Heart valve leaflet modifier

Abstract

Systems and methods for modifying heart valve leaflets with leaflet crossing tools and cutting elements.

Description

[0001] Related Applications

[0002] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63 / 364,263, filed on May 5, 2022, entitled “Heart Valve Leaflet Modification,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to novel and advantageous transcatheter delivered valve repair devices. More specifically, the devices herein address problems associated with the treatment of pathologies involving heart valves, such as the mitral, aortic, pulmonary, and tricuspid valves. Background Art

[0004] The background description provided is to generally present the context of the present disclosure. To the extent described in this background section, the work of the presently designated inventors and aspects of the description that may not qualify as prior art at the time of filing are neither explicitly nor implicitly admitted as prior art with respect to the present disclosure.

[0005] A common cardiovascular pathology is valvular heart disease, which may involve narrowing (i.e., stenosis), incompetence (i.e., insufficiency or regurgitation), or a combination of both affecting a patient's heart valves. When valvular heart disease occurs, the chambers of the heart are adversely remodeled, leading to heart failure, severe morbidity, and impaired survival.

[0006] Open surgery is usually performed to address this condition, but transcatheter therapy to repair or replace the valve is often preferred. The minimally invasive treatment approach offered by transcatheter therapy minimizes perioperative and postoperative recovery.

[0007] Transcatheter approaches to treating valvular heart disease involve repairing the valve or performing a complete replacement, whereby a prosthesis is implanted within the patient's native valve. In other cases, a prosthesis may be implanted within a previously placed prosthesis (e.g., a valve-in-valve) that has become dysfunctional or dislodged.

[0008] Transcatheter treatment for valvular heart disease is usually performed with the native leaflets or prosthetic material intact. Unfortunately, the native leaflets or prosthetic material left in place may interfere with the success of subsequent repair or replacement. In some cases, the risk of interference is too high and successful transcatheter treatment is not possible.

[0009] One specific example is transcatheter mitral valve replacement, in which a valve prosthesis is implanted into the patient's native mitral valve device or a previously placed prosthesis. Due to the proximity of the mitral annulus to the left ventricular outflow tract, transcatheter mitral valve replacement can result in positioning of the native or prosthetic leaflets in the direction of systolic flow and cause obstruction.

[0010] Another specific example is transcatheter aortic valve replacement, in which a valve prosthesis is implanted into a patient's native aortic valve device or a previously placed prosthesis. Because the aortic valve annulus is close to the coronary arteries, transcatheter aortic valve replacement can result in displacement of the native or prosthetic leaflets near the origin of the coronary arteries and compromise coronary flow. This impairment of coronary flow can lead to myocardial infarction, ischemia, and death.

[0011] In yet another example, it is desirable to modify or remove the native valve leaflets or prosthetic valve leaflets in order to perform valve repair or replacement. These situations may occur due to severe degeneration of the leaflets (e.g., large calcifications). Such leaflet modification or removal can improve the safety of subsequent valve implantation, as well as increase the effectiveness of valve implantation by creating more space for the prosthesis (i.e., increasing the effective orifice area).

[0012] Due to the challenges of open-heart surgery and the preference for transcatheter-delivered therapies, catheter-based approaches are needed to modify and / or remove both native and prosthetic leaflets. Summary of the invention

[0013] The following presents a simplified summary of one or more embodiments of the present disclosure in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments, and is neither intended to identify key or critical elements of all embodiments nor to indicate the scope of any or all embodiments.

[0014] The present invention relates to systems and methods for modifying and removing autologous valve leaflets and prosthetic valve leaflets. The present invention is composed of a delivery catheter (DC), a leaflet crossing tool (LCT) and a cutting element (CE). Each part or the entire device contains a biocompatible material. In at least one embodiment, the DC is steerable and assembled in another steerable guide catheter (SGC). In at least one embodiment, the LCT is first placed across the leaflet to determine the site and amount of cutting to be performed, and then engaged with the CE. The CE takes into account the size and shape suitable for cutting the target tissue and is then used to cut the valve leaflet. In at least one embodiment, the CE and LCT are used as a closed loop to capture the cut leaflet tissue for removal. In at least one alternative embodiment, the cut tissue is removed by mechanical suction of the SGC or DC.

[0015] Although multiple embodiments are disclosed, other embodiments of the present disclosure will be apparent to those skilled in the art from the detailed description that shows and describes the illustrative embodiments below. As will be appreciated, the various embodiments of the present disclosure can be modified in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Therefore, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter regarded as forming the various embodiments of the present disclosure, it is believed that the disclosure will be better understood from the following description taken in conjunction with the accompanying drawings, in which:

[0017] 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 leaflet (AML), posterior mitral leaflet (PML), left ventricle (LV), left atrium (LA); the anterior (A) and posterior (P) parts of the MV are labeled;

[0018] Figure 2A-2B is a top view of the MV showing the AML, PML, and free edge (FE) of the leaflet; the A, P, medial (Med), and lateral (Lat) parts are labeled; Figure 2A It is a cross-sectional view of the heart during systole; Figure 2B It is a cross-sectional view of the heart in diastole;

[0019] Figure 3 An embodiment of LCT and CE delivered within DC and SGC is shown. The CE is shown as a ring-shaped configuration, which can be enlarged or changed in shape to accommodate the desired amount and location of tissue to be removed;

[0020] Figure 4A-4H Various embodiments of LCTs that can be used to traverse and entrap cut tissue are shown;

[0021] Figure 5A-5F A technique for modifying and removing leaflet tissue involving the MV using the present disclosure is shown; the aorta, left atrium (LA), MV, and left ventricle (LV) are shown;

[0022] Figure 5G-Figure 5L An embodiment for modifying and removing lobular tissue is shown;

[0023] Figure 6A-6K shows an MV after using the present disclosure in several embodiments, indicating that a portion of a valve leaflet is removed and a new leaflet edge (NE) is created;

[0024] Figure 7A-7F is a cross-sectional view of the heart focused on the AV;

[0025] Figure 8A-8H An AV after use of the present disclosure is shown, showing the left (L), right (R), and non-coronary (N) cusps of the AV and a portion of the valve leaflet being removed, and a new leaflet edge (NE) being created;

[0026] Figure 9A-9H Different embodiments of CEs that can be used to cut lobular tissue are shown; cutting elements on the CE are represented by dots;

[0027] Fig.10 An embodiment of an LCT is shown;

[0028] Fig.11 An embodiment of a CE is shown;

[0029] Fig.12 A rendering of the mitral valve is shown;

[0030] Figures 13A-13F A method of modifying a leaflet of a mitral valve is shown;

[0031] Fig.14 Elements of a method for modifying leaflets of a mitral valve are shown;

[0032] Fig.15 Elements of a method for modifying leaflets of a mitral valve are shown;

[0033] Fig.16 Elements of a method for modifying leaflets of a mitral valve are shown; and,

[0034] Fig.17 Leaflet modifications are shown. DETAILED DESCRIPTION

[0035] The present disclosure relates to treating pathologies in the aortic root and ascending aorta using devices deployed via catheters. Although the present disclosure discusses embodiments herein with respect to the aortic root and ascending aorta of a patient, these embodiments may be applicable to any valve of a patient's heart, and the present disclosure should not be construed as limited to this application. The embodiments described herein may be applicable to repairing other valves and chambers of the human heart.

[0036] In the following detailed description, many specific details are set forth in order to provide a comprehensive understanding of some embodiments. However, it will be appreciated by those skilled in the art that some embodiments may be practiced without these specific details. In other instances, well-known methods, processes, components, units, and / or circuits are not described in detail to avoid obscuring the discussion.

[0037] Heart valve leaflets may be autologous or prosthetic. Modification and / or removal of heart valve leaflets may be performed to directly repair the function of the valve, or to facilitate its subsequent repair or treatment with valve replacement by other means. Modification and / or removal of heart valve leaflets may be customized to the patient and subsequent treatment (when indicated).

[0038] refer to Figure 1 and Figure 2A-2B , the MV is generally composed of two leaflets, the AML and PML with the FE of the two leaflets, in which coaptation occurs for valve function in both systole and diastole.

[0039] When transcatheter MV replacement (TMVR) is performed, the AML generally remains intact. Remnants of the AML exist around the neovalvular frame that protrudes into the native LVOT. Under different circumstances (such as if the size of the native LVOT is relatively small, if it is set at an unfavorable angle relative to the MV, or if the TMVR prosthetic frame has a configuration that protrudes into the LVOT), TMVR may obstruct flow in the LVOT.

[0040] In this case, the protrusion of the neovalvular frame with the surrounding AML can obstruct the systolic flow of the heart, leading to impaired stroke volume, low cardiac output, and possible death. The likelihood of LVOT obstruction with TMVR is predicted by preoperative imaging with cardiac computed tomography or echocardiography. Patients with a significant likelihood of LVOT obstruction with TMVR are generally not permitted to undergo TMVR implantation due to the perioperative risks.

[0041] The incision and modification of AML by off-label use of catheters, traps, and wires (also known as the "LAMPOON" procedure) has been described. The procedure is limited by the relative lack of control over the location of the incision, the amount of incision, and the inability to remove lobular tissue.

[0042] Herein, a tool and method thereof are described for accurately and precisely cutting and removing MV leaflets to minimize the risk of LVOT obstruction by TMVR, thereby allowing more patients to receive this beneficial therapy to treat mitral valve disease.

[0043] Figure 3 At least one embodiment is shown with LCT and CE delivered via a DC housed within an SGC. The LCT is comprised of a needle or straight segment 300 with a traversing element 302 at the distal tip of the straight segment 300, the function of which is facilitated by mechanical and / or electrical energy. The LCT is applied to a target site of a valve leaflet for leaflet traversal. Figure 4A As shown, in at least one embodiment, the LCT is a straight element.

[0044] like Figure 4B-Figure 4H As shown, in other embodiments, the LCT can be spiral, square or rectangular, circular or elliptical, curved or another geometric configuration, together with a proximal portion P, which can be pre-formed into a foldable configuration and used as an adhesion mechanism for adhering tissue. In at least one embodiment, the proximal portion P is exposed after the leaflet is traversed. In at least one embodiment, the proximal portion P can be folded to have an anchoring function to hold the leaflet tissue after the leaflet tissue is cut. In at least one embodiment, the LCT contains one or more elements E that allow energy to be delivered to cut the leaflet tissue.

[0045] Figure 5A-5F Modification and / or removal of leaflet tissue involving a MV is shown in at least one embodiment of the present disclosure.

[0046] refer to Figure 5A , the system was delivered to the desired lobular site with SGCs and DCs were positioned adjacent to AMLs.

[0047] refer to Figure 5B , the SGC has been withdrawn, exposing the DC. The LCT is then advanced beyond the DC. The LCT is then used to engage and traverse the AML using, for example, radiofrequency, electrical, or mechanical energy, and is subsequently advanced further into the LV.

[0048] The location selected for placement and engagement of the LCT is based on the location and amount of leaflet tissue cutting and / or removal desired, as indicated by the bidirectional arrows. For example, one may choose to target relatively more tissue by positioning the LCT near the annulus, or relatively less tissue by positioning the LCT near the free edge (FE) of the leaflet. The CE may also be positioned across any segment of the MV to get as close as possible to the FE or MV annulus as desired.

[0049] See also Figure 5C In at least one embodiment, the CE is then advanced through the MV orifice and diverted to wrap around the LCT. In at least one other embodiment, the CE has a distal tip that allows it to pass directly through the valve leaflets, similar to the function of the LCT. In the latter case, one may choose to perform the traversal of the CE in this manner so as not to modify the FE of the MV.

[0050] refer to Figure 5D and Figure 5E , the CE is placed over the LCT and then retracted proximally to engage the MV leaflet, as indicated by the directional arrows, and the CE cuts the leaflet tissue using mechanical and / or electrical power. In one embodiment, the cut tissue remains adhered to the LCT, and the CE is configured to close around the cut tissue and hold the CE against the LCT so as to entrap the cut leaflet tissue.

[0051] refer to Fig. 5F In at least one other embodiment, the cut lobule tissue is held in place by an adhesion mechanism in the form of at least one proximal portion P of the LCT, which adhesion mechanism is exposed prior to cutting. As previously described, in at least one embodiment, the proximal portion P can be spiral, square or rectangular, circular or elliptical or another geometric configuration, and the proximal portion P can be preformed into a foldable configuration. In at least one embodiment, the retaining element can have a braid or adhesive material that facilitates adhesion of the cut tissue to the LCT. In at least one embodiment, the proximal portion P can have a geometric configuration that is exposed after the lobule is traversed.

[0052] The procedure using LCT and CE can be applied multiple times to the same MV leaflet or to different locations on the MV (including AML and PML) to modify and remove tissue when necessary. The shape and size of both CE and LCT can be varied to suit the needs of the patient and subsequent treatment.

[0053] Figure 5G-Figure 5L Another embodiment of the present disclosure is shown involving modification and / or removal of leaflet tissue of a MV.

[0054] The system is delivered with SGCs to the desired lobular site, and DCs are placed in a manner similar to Figure 5A The approach shown in is positioned adjacent to the AML.

[0055] refer to Figure 5G , the SGC has been withdrawn, exposing the DC. The LCT is then advanced beyond the DC. The LCT is then used to engage and traverse the AML, for example, by radiofrequency, electrical, or mechanical energy, and subsequently further advanced into the LV. The LCT has a retaining element in the form of a barb B at or near its tip. The LCT also has an adhesion mechanism in the form of a tensioning element TE proximal to the barb B for tensioning the leaflet during the procedure.

[0056] The location selected for placement and engagement of the LCT is based on the location and amount of leaflet tissue cutting and / or removal desired, as indicated by the bidirectional arrows. For example, one may choose to target relatively more tissue by positioning the LCT near the annulus, or relatively less tissue by positioning the LCT near the free edge (FE) of the leaflet. The CE may also be positioned as needed to traverse any segment of the MV to get as close as possible to the FE or MV annulus.

[0057] refer to Figure 5HIn at least one embodiment, the CE is then advanced through the MV orifice and diverted to wrap around the LCT. In at least one other embodiment, the CE has a distal tip that allows it to pass directly through the valve leaflets, similar to the function of the LCT. In the latter case, one may choose to perform the traversal of the CE in this manner so as not to modify the FE of the MV.

[0058] refer to Fig.5I and Figure 5J , the CE is placed over the LCT and then retracted proximally to engage the MV leaflet, as indicated by the directional arrows. When retracted to engage the MV leaflet, the tensioning element TE is used to "backstop" or hold the leaflet against the CE in tension. In other words, the TE is used to counteract the cutting force of the LCT. The CE then cuts the leaflet tissue using mechanical and / or electrical power. In one embodiment, the cut tissue remains adhered to the LCT, and the CE is configured to close around the cut tissue and hold the CE against the LCT so as to entrap the cut leaflet tissue.

[0059] refer to Figure 5K In at least one other embodiment, the cut lobule tissue is held or retained by at least the barbs B of the LCT.

[0060] In yet another embodiment, a structure similar to the tensioning element TE may be incorporated at the tip instead of the barb. The operation of this embodiment is similar to that described with respect to the previously discussed embodiments.

[0061] The procedure using LCT and CE can be applied multiple times to the same MV leaflet or to different locations on the MV (including AML and PML) to modify and remove tissue when necessary. The shape and size of both CE and LCT can be varied to suit the needs of the patient and subsequent treatment.

[0062] Figure 6A-6K MV after use of the present disclosure in at least several embodiments is shown, wherein portions of the valve leaflets removed create a newly formed leaflet edge (NE). The different amounts and configurations of leaflet tissue removed vary depending on the shape and size of the CE and the traversal location of the LCT.

[0063] Similar to the methods used for MV, other native heart valve leaflets and prosthetic leaflets can be modified and removed with the present invention. Heart valve leaflets and prosthetic leaflets are most commonly in a tri-leaflet configuration that is different from MV, but the technical use of the present invention is similar regardless of the number of valve leaflets present and whether the leaflets are native or prosthetic. The SGC and DC can be used to access the valve leaflets antegrade or retrograde for their modification and removal using the present invention.

[0064] For example, Figure 7A-7F The use of the present disclosure for an aortic valve AV is shown. Fig. 7A , after the vessel enters the ascending aorta, the DC advances to a small leaflet apex of the AV. Figure 7B , the cutting element of the LCT is used to engage and traverse the AV leaflet, for example, by electrical or mechanical energy, which is then further advanced into the LV. As described above for the MV, the location of placement of the LCT is based on the location and amount of leaflet tissue cutting and / or removal desired. For example, a user can choose to target relatively more tissue by positioning the LCT near the aortic annulus, or relatively less tissue by positioning the LCT near the FE. The LCT can also be positioned to traverse any segment of the AV (i.e., the L, R, or N cusps) close to the FE or AV annulus as desired.

[0065] refer to Figure 7C In at least one embodiment, the CE is then advanced through the AV orifice and diverted to wrap around the LCT. In at least one other embodiment, the LCT has a distal tip that allows it to pass directly through the valve leaflets, similar to the function of the CE (using mechanical or electrical energy). In the latter case, one may choose to perform the crossing of the LCT there to preserve the native FE of the AV. The CE can be delivered across the AV in its own sleeve or in an expanded state.

[0066] refer to Fig.7D , the CE is placed over the LCT and then retracted proximally to engage the AV leaflets, as indicated by the directional arrows.

[0067] refer to Fig. 7E , using, for example, mechanical force and / or electrical force, the CE cuts the lobule tissue. In one embodiment, the cut tissue remains adhered to the LCT, and the CE closes to the LCT as a trap to hold the cut lobule tissue.

[0068] refer to Figure 7F In at least one other embodiment, the cut lobule tissue is held in place by at least one proximal element P of the LCT, which in one embodiment is exposed prior to cutting (as described above, the proximal element P can be used to help apply a reaction force during the cutting process). As previously described, in at least one embodiment, such a retaining element P can be spiral, square or rectangular, circular or oval, or another geometric configuration, and can be preformed into a foldable configuration. The retaining element P can have a braid or adhesive material that facilitates adhering the cut tissue to the LCT.

[0069] refer to Figure 8A-8H, shows an example of a resulting leaflet configuration of an AV in which portions of the valve leaflets are removed to create a new leaflet edge (NE). The location, size, and amount of tissue removed 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.

[0070] refer to Figure 9A-9H , various embodiments of CEs that can be used to cut lobular tissue are shown. Cutting features on a CE are represented by points on the line portion of the CE. In at least one embodiment, a CE has multiple cutting components that can be positioned according to the desired cutting configuration.

[0071] Various types of cutting 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 herein by reference in its entirety.

[0072] In at least one embodiment, mechanical suction can be applied to hold the cut leaflets in place while being removed from the body.

[0073] In at least one embodiment, a capture basket can be deployed distally or proximally to help hold the cut leaflet in place while being removed from the body. In at least one embodiment, the basket facilitates the passage of the cut leaflet tissue into the delivery catheter for removal. A basket configuration that can be used in this manner 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.

[0074] refer to Fig.10 , discloses an additional embodiment of the LCT 100 of the present disclosure. In one embodiment, the LCT 100 has three extensions 102 for penetrating and traversing lobular tissue. In one embodiment, the tips of the extensions include electrodes for applying cutting energy (e.g., RF energy) to the lobular tissue.

[0075] refer to Fig.11 , shows an additional embodiment of the CE 110 of the present disclosure. The CE 110 has a ring that can cut tissue in a manner similar to the previously disclosed embodiments of the CE. In one embodiment, the CE 110 includes an electrode for applying electrical cutting energy to lobular tissue.

[0076] refer to Fig.12, a rendering of the mitral valve MV with an anterior mitral valve leaflet 120 and a posterior mitral valve leaflet 122 is shown.

[0077] refer to Figures 13A-13F , showing a method according to the present disclosure, wherein Fig.13A The extended portion 102 of the LCT 100 is shown having pierced or penetrated the anterior mitral valve leaflet 120 .

[0078] refer to Fig. 13B , the CE 110 has extended through the mitral valve opening into the left ventricle and is directed toward the extension 102 of the LCT 100 .

[0079] refer to Fig. 13C , the CE 110 has been secured around the extension 102 , and the electrode is placed in contact with the anterior mitral leaflet tissue 120 .

[0080] refer to Fig.13D , the electrodes of CE 110 are activated to produce a cutting effect on the tissue of the anterior leaflet 120 of the mitral valve.

[0081] refer to Fig.13E , the CE 110 has been retracted and the cut tissue 132 has been excised from the anterior mitral valve leaflet 120 and remains on or near the extension 102 of the LCT 100 .

[0082] refer to Fig.13F , depicts the final leaflet configuration after LCT 100 withdrawal.

[0083] See also Fig.14 and Fig.15 They are shown as Fig.13A and Fig. 13C A drawing of the operations that occur as shown in .

[0084] refer to Fig.16 , shows another embodiment of a method according to the present disclosure. After the extension 102 penetrates 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 cone or "teepee". This action is used to create tension or tightness in the tissue to facilitate the cutting action of the CE 110.

[0085] refer to Fig.17 , an embodiment of an implemented leaflet modification is shown as a triangular shape having 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, many different locations and shapes of leaflet modifications may be implemented as described in other embodiments of the present disclosure.

[0086] As used herein, any reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in conjunction with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in different places in this specification are not necessarily all referring to the same embodiment.

[0087] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to the process, method, article, or apparatus.

[0088] In addition, "a" or "an" is used to describe elements and components of the embodiments of this document. This is done only for convenience and to give a general meaning to the specification. The description should be understood to include one or at least one, and the singular also includes the plural unless it is obvious that there is another meaning.

[0089] Still further, the drawings depict the preferred embodiments for purposes of illustration only. Those skilled in the art will readily recognize from the discussion herein that alternative embodiments of the structures and methods shown herein may be employed without departing from the principles described herein.

[0090] Upon reading this disclosure, those skilled in the art will recognize additional alternative structures and functional designs. Therefore, although specific embodiments and applications have been illustrated and described, it should be understood that the disclosed embodiments are not limited to the precise configurations and components disclosed herein. Without departing from the spirit and scope defined in the appended claims, those skilled in the art can obviously make various modifications, changes and variations to the arrangement, operation and details of the methods and devices disclosed herein.

Claims

1. A system for modifying a heart valve leaflet, comprising: Leaflet traversing tool, the leaflet traversing tool comprising: distal tip; the distal tip being sized and shaped for placement at a plurality of different locations on a heart valve leaflet; a tissue penetrating mechanism disposed at the distal tip; an adhesion mechanism disposed on the leaflet-traversing tool and associated with the distal tip to adhere the cut leaflet tissue to the leaflet-traversing tool; A cutting element is associated with the leaflet-traversing tool.

2. The system according to claim 1, wherein: The distal tip includes an energy delivery contact point.

3. The system according to claim 1, wherein: The adhesion mechanism includes a shape of the leaflet-traversing tool at a location proximal to the distal tip.

4. The system according to claim 1, wherein: The adhesion mechanism includes a coating disposed on the leaflet traversing tool.

5. A method of modifying a heart valve leaflet, comprising: Identify target locations on the leaflet; penetrating one side of the leaflet at the target location with a leaflet-penetrating tool; introducing a cutting tool into opposite sides of the leaflet; The leaflet is cut with the cutting tool to produce a modified leaflet.

6. The method according to claim 5, wherein: Cutting the leaflet includes forming a slit in the leaflet.

7. The method of claim 5, further comprising cutting the leaflet to produce resected leaflet tissue.

8. The method according to claim 7, further comprising: adhering the excised lobule tissue to the lobule-traversing tool; The excised lobular tissue is removed.

9. The method according to claim 5, further comprising: advancing the traversing tool after penetrating one side of the leaflet so that tissue at the target location is pulled in the same direction as the advancing traversing tool; After the cutting tool is introduced to the opposite side of the leaflet, the cutting tool is then positioned around the tissue at the target location pulled with the advancing traversing tool.

10. A system for modifying a heart valve leaflet, comprising: a leaflet-traversing tool configured to penetrate tissue of a heart valve leaflet; a cutting element associated with the leaflet traversing tool and having a ring sized for placement around the leaflet traversing tool; A proximal portion is disposed on the leaflet traversing tool for capturing tissue cut from a heart valve leaflet.

11. The system according to claim 10, wherein: The loop of the leaflet crossing tool is tightenable.

12. The system according to claim 10, wherein: The proximal portion is foldable.

13. The system according to claim 10, wherein: Electrodes are disposed on the leaflet-traversing tool for cutting tissue of the heart valve leaflets.

14. A system for modifying a heart valve leaflet, comprising: Leaflet traversing tool, the leaflet traversing tool comprising: distal tip; The distal tip is sized and shaped for placement at a plurality of different locations on a heart valve leaflet; a tissue penetrating mechanism disposed at the distal tip; a retaining mechanism disposed at the region of the distal tip for contacting tissue; an adhesion mechanism disposed on the leaflet-traversing tool and associated with the distal tip to adhere the cut leaflet tissue to the leaflet-traversing tool; A cutting element is associated with the leaflet-traversing tool.

15. The system of claim 14, wherein: The retaining mechanism is a barb.

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