Patent Publication Number: US-2022225979-A1

Title: Minimally invasive heart valve repair in a beating heart

Description:
RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Application No. 63/140,198 filed Jan. 21, 2021, which is hereby fully incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to minimally invasive repair of a heart valve while the patient&#39;s heart is beating. More particularly, embodiments of the present disclosure relate to minimally invasive systems and methods for performing an edge to edge heart valve leaflet repair on a beating heart. 
     BACKGROUND OF THE INVENTION 
     Various types of surgical procedures are currently performed to investigate, diagnose, and treat diseases of the heart and the great vessels of the thorax. Such procedures include repair and replacement of mitral, aortic, and other heart valves, repair of atrial and ventricular septal defects, pulmonary thrombectomy, treatment of aneurysms, electrophysiological mapping and ablation of the myocardium, and other procedures in which interventional devices are introduced into the interior of the heart or a great vessel. 
     Of particular interest are intracardiac procedures for surgical treatment of heart valves, especially the mitral and aortic valves. Tens of thousands of patients are diagnosed with aortic and mitral valve disease each year. Various surgical techniques may be used to repair a diseased or damaged valve, including annuloplasty (contracting the valve annulus), quadrangular resection (narrowing the valve leaflets), commissurotomy (cutting the valve commissures to separate the valve leaflets), shortening mitral or tricuspid valve chordae tendonae, reattachment of severed mitral or tricuspid valve chordae tendonae or papillary muscle tissue, and decalcification of valve and annulus tissue. Alternatively, the valve may be replaced by excising the valve leaflets of the natural valve and securing a replacement valve in the valve position, usually by suturing the replacement valve to the natural valve annulus. Valve replacement, however, can present a number of difficulties including that the invasiveness of the procedure can lead to long recovery times and that the irregular shape of the valve annulus can cause difficulty in properly fixing and orienting the replacement valve, which can lead to leaks and other problems. Therefore, in situations where patients can adequately be treating by repairing, rather than replacing, the valve, it is generally preferable to do so. 
     The mitral and tricuspid valves inside the human heart include an orifice (annulus), two (for the mitral) or three (for the tricuspid) leaflets and a subvalvular apparatus. The subvalvular apparatus includes multiple chordae tendineae, which connect the mobile valve leaflets to muscular structures (papillary muscles) inside the ventricles. Rupture or elongation of the chordae tendineae results in partial or generalized leaflet prolapse, which causes mitral (or tricuspid) valve regurgitation. A commonly used technique to surgically correct mitral valve regurgitation is the implantation of artificial chordae (usually 4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the valve and the papillary muscle. This traditionally open-heart operation was generally carried out through a median sternotomy and required cardiopulmonary bypass with aortic cross-clamp and cardioplegic arrest of the heart, as described above. 
     Using such open heart techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of a replacement valve through the atriotomy for attachment within the heart. However, these invasive open-heart procedures produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of current techniques. 
     Techniques have been developed and are under development for minimally invasive thorascopic repair of heart valves while the heart is still beating. Int&#39;l Pub. No. WO 2006/078694 A2 to Speziali discloses a thorascopic heart valve repair method and apparatus. Instead of requiring open heart surgery on a stopped heart, the thorascopic heart valve repair methods and apparatus taught by Speziali utilize fiber optic technology in conjunction with transesophageal echocardiography (TEE) as a visualization technique during a minimally invasive surgical procedure that can be utilized on a beating heart. More recent versions of these techniques are disclosed in U.S. Patent Application Publication Nos. 2009/0105751 and 2009/0105729 to Zentgraf, which disclose an integrated device that can enter the heart chamber, navigate to the leaflet, capture the leaflet, confirm proper capture, and deliver a suture as part of a mitral valve regurgitation (MR) repair. These references are hereby incorporated by reference herein in their entirety. 
     An alternative to the above-described techniques that insert a suture through a single valve leaflet and anchor the suture to the heart is an edge to edge valve repair. In a traditional Alfieri edge to edge procedure, the edges of adjacent valve leaflets are sutured together to coapt the leaflets using an open surgical approach. This technique has been mimicked in minimally invasive, beating heart procedures by employing a clip that joins the leaflets together rather than a suture. U.S. Patent Publication No. 2004/0044365 to Bachman discloses a technique for minimally invasively accessing the heart through an endovascular approach to perform an edge to edge repair. There is, however, a need for a technique for performing an edge to edge repair on a beating heart of a patient that secures the leaflets together at a proper tension in a more effective manner. 
     SUMMARY OF THE INVENTION 
     Disclosed herein are minimally invasive systems and methods for performing an edge to edge repair of a heart valve on a beating heart of a patient. One or more sutures are inserted into a plurality of leaflets of the heart valve while the heart is beating through a minimally invasive access. The sutures can be threaded through a suture crimp that is advanced to the leaflets. A movable gate on the suture crimp can be actuated to secure the sutures at an appropriate tension to maintain the leaflets in a coapted position. 
     In an embodiment, a suture crimping system is configured to crimp a suture attached to a heart valve leaflet in a beating heart of a patient. The suture crimp can include a crimp body having an open interior and a pair of locking grooves and a suture clamping gate movable within the crimp body and having a pair of locking tabs corresponding to the locking grooves. The suture crimp can define a loading aperture through the crimp body configured to enable a suture to pass through the crimp body. The system can further include a crimp holder having a first plate and a second plate defining a suture crimp space therebetween configured to releasably contain the suture crimp. The crimp holder can further comprise a pull rod extending between the first plate and the second plate and a pair of lock tab actuators extending between the first plate and the second plate configured to interface with corresponding lock tab actuator apertures in the suture clamping gate of the suture crimp to enable the crimp holder to move the suture clamping gate. When a force is applied proximally on the pull rod of the crimp holder, the crimp holder and the suture clamping gate can move proximally with respect to the crimp body to move the suture clamping gate from an open position in which the suture can slide freely through the loading aperture and a closed position in which the locking tabs of the suture clamping gate interface with the locking grooves in the crimp body to lock the suture clamping gate in the closed position to securely hold a tensioned suture between the suture clamping gate and the crimp body. 
     A suture crimp configured to crimp a suture attached to a heart valve leaflet in a beating heart of a patient can include a crimp body having an open interior and a pair of locking grooves and further defining a loading aperture through the crimp body configured to enable a suture to pass through the crimp body. A suture clamping gate can be movable within the crimp body and have a pair of locking tabs corresponding to the locking grooves. The suture clamping gate can be configured to move proximally with respect to the crimp body to move the suture clamping gate from an open position in which the suture can slide freely through the loading aperture and a closed position in which the locking tabs of the suture clamping gate interface with the locking grooves in the crimp body to lock the suture clamping gate in the closed position to securely hold a tensioned suture between the suture clamping gate and the crimp body. 
     In an embodiment, a method of crimping a suture attached to a heart valve leaflet in a beating heart of a patient can include minimally invasively inserting a suture into a heart valve leaflet in a beating heart of a patient such that a pair of free ends of the suture extend from the leaflet out of the body, threading the free ends of the suture through a loading aperture of a crimp body of a suture crimp and delivering the suture crimp along the suture to the leaflet with a delivery catheter. The tension on the suture can then be adjusted to a desired tension. A force can them be applied proximally on a suture clamping gate disposed within the crimp body to move the suture clamping gate proximally with respect to the crimp body from an open position in which the suture can slide freely through the loading aperture and a closed position in which locking tabs of the suture clamping gate interface with locking grooves in the crimp body to lock the suture clamping gate in the closed position to securely hold the suture between the suture clamping gate and the crimp body at the desired tension. 
     In an embodiment, a method of crimping a suture attached to a heart valve leaflet in a beating heart of a patient can include minimally invasively inserting a suture into a heart valve leaflet in a beating heart of a patient such that a pair of free ends of the suture extending from the leaflet out of the body, threading the free ends of the suture through a loading aperture of a crimp body of a suture crimp and delivering the suture crimp and a crimp holder releasably connected to the suture crimp along the suture to the leaflet with a delivery catheter. A tension on the suture can then be adjusted to a desired tension. A proximal force can then be applied on a pull rod of the crimp holder to cause the crimp holder and the suture clamping gate to move proximally with respect to the crimp body to move the suture clamping gate from an open position in which the suture can slide freely through the loading aperture and a closed position in which locking tabs of the suture clamping gate interface with locking grooves in the crimp body to lock the suture clamping gate in the closed position to securely hold the suture between the suture clamping gate and the crimp body at the desired tension. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
         FIG. 1A  is a plan view of a suture crimp according to an embodiment. 
         FIG. 1B  is a section view of the suture crimp of  FIG. 1A . 
         FIG. 1C  is an isometric view of the suture crimp of  FIGS. 1A-1B . 
         FIG. 2A  is an isometric view of a suture crimp with a covering according to an embodiment. 
         FIG. 2B  is a plan view of the suture crimp and covering of  FIG. 2A . 
         FIG. 3A  is a section view of a suture with an open suture crimp according to an embodiment. 
         FIG. 3B  is section view of a suture with the suture crimp of  FIG. 3A  in a closed position. 
         FIG. 4A  is a plan view of a suture crimp shown without a top plate in an open position according to an embodiment. 
         FIG. 4B  is a plan view of the suture crimp of  FIG. 4B  shown without a top plate in a closed position. 
         FIG. 5A  is a plan view of crimp holder according to an embodiment. 
         FIG. 5B  is an isometric view of the crimp holder of  FIG. 5A . 
         FIG. 6  is an isometric view of a suture crimp contained within a crimp holder according to an embodiment. 
         FIG. 7A  is a plan view of the suture crimp and crimp holder of  FIG. 6  in an open position. 
         FIG. 7B  is a plan view of the suture crimp and crimp holder of  FIG. 6  in a closed position. 
         FIG. 8  depicts a suture crimp and crimp holder positioned in the distal tip of a delivery catheter according to an embodiment. 
         FIGS. 9A and 9B  depict a catheter tip of the delivery catheter of  FIG. 8 . 
         FIG. 10  depicts the suture crimp and crimp holder positioned in the delivery catheter of  FIG. 8  with the catheter tip removed. 
         FIG. 11  is a schematic cross-sectional view of a heart. 
         FIG. 12  is a schematic top plan view of a mitral valve. 
         FIG. 13A  is a schematic cross-sectional view of a heart with a normal mitral valve. 
         FIG. 13B  is a partial schematic cross-sectional view of a heart with an abnormal mitral valve. 
         FIG. 14  is an isometric view of an instrument that can be employed with some embodiments of the disclosure. 
         FIG. 15  is a detailed isometric view of the distal end of the instrument of  FIG. 14 . 
         FIG. 16A  is a detailed side elevation view of the distal end of the instrument of  FIG. 14  showing the tip in a closed position. 
         FIG. 16B  is a detailed side elevation view of the distal end of the instrument of  FIG. 14  showing rods inside the instrument that are capable of sliding to move the tip to an open position. 
         FIG. 17  is a detailed isometric view of the distal end of the instrument of  FIG. 14  showing the needle lumen and four fiberoptic channels that are disposed around the needle lumen. 
         FIGS. 18A-8F  depict detailed isometric view of a suture being deployed into a heart valve leaflet according to embodiments of the disclosure. 
         FIGS. 19A-19C  schematically depict a procedure for inserted a suture crimp for an edge to edge heart valve repair according to an embodiment. 
         FIG. 20  depicts a suture crimp according to an embodiment. 
         FIGS. 21A-21D  are endoscopic images depicting sutures inserted into leaflets as described herein. 
         FIGS. 22A-22D  are endoscopic images depicting a suture crimp having been delivered along the sutures of  FIGS. 21A-22D  to the leaflets. 
         FIGS. 23A-23D  are endoscopic images depicting the suture crimp of  FIGS. 22A-22D  after actuation. 
         FIGS. 24A-24D  are endoscopic images depicted the suture crimp of  FIGS. 23A-23D  on the leaflets after the excess suture has been cut. 
     
    
    
     While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. 
     DETAILED DESCRIPTION 
     A mitral valve is schematically depicted in  FIGS. 11-13B . Situated between the left atrium and left ventricle, the mitral valve consists of two flaps of tissue, or leaflets (a posterior leaflet and an anterior leaflet). The mitral valve annulus forms a ring around the valve leaflets, thereby connecting the leaflets to the heart muscle. Papillary muscles are located at the base of the left ventricle. Tendon-like cords called chordae tendineae anchor the mitral valve leaflets to the papillary muscles. Normal chordae tendineae prevent the leaflets from prolapsing, or inverting, into the left atrium, as depicted in  FIG. 13A . 
     A properly functioning mitral valve opens and closes fully. When the mitral valve fails to fully close, as depicted in  FIG. 13B , blood from the left ventricle is able to flow backward into the left atrium instead of flowing forward into the aorta. This backflow of blood through the heart valve is called regurgitation. The regurgitation of blood through the heart due to the failure of the mitral valve to close properly (coapt) is the condition known as mitral valve regurgitation (MR). A common symptom of mitral valve regurgitation is congestion of blood within the lungs. If left untreated, severe MR can eventually lead to serious cardiac arrhythmia and/or congestive heart failure (CHF). 
     Mitral valve regurgitation can be caused by any number of conditions, including mitral valve prolapse (a condition in which the leaflets and chordae tendineae of the mitral valve are weakened resulting in prolapse of the valve leaflets, improper closure of the mitral valve, and the backflow of blood within the heart with each contraction of the left ventricle), damaged chords (wherein the chordae tendineae become stretched or ruptured, causing substantial leakage through the mitral valve), ventricular enlargement, rheumatic fever (the infection can cause the valve leaflets to thicken, limiting the valve&#39;s ability to open, or cause scarring of the leaflets, leading to regurgitation), endocarditis (an infection inside the heart), deterioration of the mitral valve with age, prior heart attack (causing damage to the area of the heart muscle that supports the mitral valve), and a variety of congenital heart defects. As MR becomes exacerbated over time, the condition can become more severe, resulting in life-threatening complications, including atrial fibrillation (an irregular heart rhythm in which the atria beat chaotically and rapidly, causing blood clots to develop and break loose and potentially result in a stroke), heart arrhythmias, and congestive heart failure (occurring when the heart becomes unable to pump sufficient blood to meet the body&#39;s needs due to the strain on the right side of the heart caused by fluid and pressure build-up in the lungs). 
     The present application describes various devices and methods that can be employed on the beating heart of a patient in a minimally invasive manner to treat mitral valve regurgitation as described above. Embodiments as described herein can be used to restrain a prolapsing leaflet to prevent leaflet prolapse and to promote leaflet coaptation. Specifically, the disclosed embodiments can provide a minimally invasive edge to edge treatment of MR. This treatment significantly decreases trauma to surgical patients by facilitating transapical access of a beating heart via a lateral thoracotomy in a manner that eliminates certain surgical steps normally required to complete mitral valve repair procedure by sternotomy. 
     In certain embodiments, the methods and apparatus described herein can be performed or configured for edge to edge leaflet repair via transapical access. Transapical access to a heart includes all entry points that are within approximately the bottom third of the heart. As used in this patent application, transapical access to a heart includes all directions of entry and points of entry, as well as all angles of entry at each entry point. Further details regarding one embodiment of an instrument suitable for such transapical access can be found in PCT Publication No. WO 2006/078694 to Speziali, which is hereby incorporated herein by reference in its entirety, although other transapical instruments may also be utilized with various embodiments as disclosed herein. 
     In other embodiments, the methods and apparatus described herein can be performed or configured for edge to edge leaflet repair via an endovascular approach, such as a transfemoral, transeptal approach. Further details regarding one embodiment of an instrument suitable for such an endovascular access approach can be found in U.S. Patent Publication No. 2016/014737, U.S. Patent Publication No. 2019/0290260 and U.S. Patent Publication No. 2020/0093478, each of which is hereby incorporated by reference in its entirety, although other transapical instruments may also be utilized with various embodiments as disclosed herein. 
     One embodiment of an instrument  10  that can be used in performing the methods described herein is depicted in  FIGS. 14 and 15 . Instrument  10  includes a rigid metal shaft  100  having a handle  120  at its extrathoracic (proximal) end that enables the instrument to be manipulated and guided into position. Actuating mechanisms for controlling the grasping mechanism and needle mechanism located at the distal end  140  of the instrument are also mounted near the handle  120 . The grasping mechanism is operated by squeezing the scissor-grip handle  120 , and the needle mechanism is operated by moving an up-turned control shaft  122 . 
     Located on the distal, intracardiac end  140  of the instrument  10  is a grasping mechanism which can be operated to hold a valve leaflet. As shown in  FIGS. 15, 16A, 16B, and 17 , in one embodiment this mechanism is a tip  160  which is supported on the distal end of the shaft  100  by a set of rods  162 . The rods  162  slide within the shaft  100  to move the tip  160  between an open position as shown in  FIGS. 16B and 17  and a closed position as shown in  FIG. 16A  when the scissor-grip handle  120  is operated. As will be explained below, a valve leaflet is located in the gap between the open tip  160  and the distal end of shaft  100  and it is captured by closing the tip  160  to pinch the valve leaflet therebetween. 
     Disposed in a needle lumen  164  formed in the shaft  100  is a needle  180  which connects to the control shaft  122  at the proximal end of shaft  100 . Needle mechanism  180  slides between a retracted position in which it is housed in the lumen  164  near the distal end of the shaft  100  and an extended position in which it extends into the sliding tip  160  when the tip is in its closed position. As a result, if a valve leaflet has been captured between the tip  160  and the distal end of shaft  100  the needle may be extended from the lumen  164  by moving control shaft  122  to puncture the captured leaflet and pass completely through it. 
     The distal end of the shaft  100  can also contain an artificial chorda, or suture  18  that is to be deployed in the patient&#39;s heart. The suture  18  is typically a 4-0 or 5-0 suture manufactured by a company such as Gore-Tex. This suture  18  is deployed by the operation of the grasping mechanism and the needle mechanism  180  as described in more detail below. Further details regarding example embodiments of such devices can be found in U.S. Pat. Nos. 8,465,500; 8,758,393; and 9,192,374, each of which is hereby incorporated by reference herein in its entirety. 
     As shown in  FIGS. 18A-18F , a suture can be deployed into a heart valve leaflet of a beating heat of a patient with instrument  10  and other similar instruments described herein. Instrument  10  is positioned around a valve leaflet  16  to be repaired as shown in  FIG. 18A . In one embodiment, the suture  18  can be folded at the middle to form a loop  19  that is positioned in the tip  160 . Both ends of the suture  18  can be disposed in a suture lumen  165  formed in the shaft  100  beneath the rods  162 . As shown in  FIG. 18B , the valve leaflet  16  is grasped by closing the tip  160 , and the needle  180  is extended to puncture the leaflet  16  and extend into the tip  160 . A notch  166  formed on one side of the needle  180  hooks the suture loop  19 . The needle  180  is then retracted back through the leaflet  16  to pull the suture loop  19  through the puncture opening as shown in  FIG. 18C . The leaflet  16  is then released and the instrument  10  is withdrawn from the heart as shown in  FIG. 18D  pulling both ends and the midpoint of the suture  18  with it. As shown in  FIG. 18E , the suture  18  is released by the instrument  10  and the surgeon inserts the two suture ends  21  through the loop  19  at its midpoint. The ends  21  are then pulled and the loop  19  slides along the suture  18  back into the heart chamber  14  where it forms a Larks head around the edge of the valve leaflet as shown in  FIG. 18F . At this point, the two free ends  21  of the suture  18  are external to the heart wall at the apex  12  of the heart. Multiple sutures  18  may be implanted in this manner. 
       FIGS. 1A-1C  depict a suture crimp  200  for crimping one or more sutures in the heart according to an embodiment. The sutures can be inserted using one or more of the devices and methods described above, e.g., transcatheter, transapically, etc. or with any other known devices and methods. In the depicted embodiment, the two free ends  21  of two sutures are depicted extending through the suture crimp, but it should be understood that greater or fewer sutures could be crimped with suture crimp. In one embodiment, a first suture is inserted through a first leaflet, a second suture is inserted through a second leaflet, and the suture crimp is employed to crimp the sutures at an appropriate tension to hold the leaflets in coaptation for an edge to edge repair of, e.g., the mitral valve. 
     Suture crimp  200  can include a crimp body including a front plate  202  and a back plate  204  each with a corresponding loading aperture  206 ,  208  through which the one or more sutures can be inserted and a pair of slots  210 ,  212 . In embodiments, the sutures can be inserted through the loading apertures  206 ,  208  outside of the body and the suture crimp  200  advanced along the sutures to the leaflet(s) into which the sutures have previously been inserted. Suture crimp  200  can further include a spacer plate  214  to which the front plate and back plate are welded or otherwise connected to establish crimp body with a desired width between plates. As can be seen most clearly in  FIG. 1C , spacer plate  214  can be thicker than front plate  202  and back plate  204  but otherwise have a generally matching shape, including a pair of slots  218  that align with the slots  210 ,  212  in the front and back plates  202 ,  204  to define actuation slots described below. As will be described in more detail below, a movable suture clamping gate  216  can be disposed within suture crimp between front  202  plate and back plate  204 . In embodiments, suture crimp  200  can be laser cut from a stainless steel sheet. 
     In some embodiments, suture crimp  200  can include an anti-thrombotic cover  220  depicted in  FIGS. 2A-2B . Cover  220  can be formed from a variety of material including, for example a woven or knitted polyester material such as Dacron, an electrospun polymer, etc. In embodiments, cover  200  can be thermally sealed around the edge of the suture crimp  200  or otherwise adhered to the metal material of the crimp  200  as shown in the figures. Cover  220  may be employed to resist clotting or thrombosis on the suture crimp  200  and/or to enhance tissue integration around the suture crimp. 
       FIG. 3A  depicts how sutures  18  can be inserted straight through the loading apertures  206 ,  208  of the suture crimp  200 . Suture clamping gate  216 , which also includes a loading aperture through which sutures can be inserted, can be spaced between front plate  202  and back plate  204  to define a pair of suture compression gaps  222  on each side of suture clamping gate  216 . As will be described in more detail below, when the suture clamping gate  216  is moved from the open position to the closed position within suture crimp  200  as depicted in  FIG. 3B , the suture  18  is clamped within the suture crimp  200  across a tortuous path in the compression gap  222  between front plate  202  and suture clamping gate  216 , around suture clamping gate  216  and between the compression gap  222  between the suture clamping gate  216  and the back plate  204 . In embodiments, the suture compression gaps  222  have a smaller width than a diameter of the suture  18  in order to compress the suture to aid in suture clamping and retention. 
       FIGS. 4A-4B  depict suture crimp  200  with front plate removed for sake of clarity in order to illustrate the operation of suture clamping gate  216  within suture crimp. Suture clamping gate  216  includes a pair of locking tabs  224  and spacer plate  214  can include a corresponding pair of locking grooves  226 . When suture clamping gate  216  is moved from the open position, the locking tabs  224  nest within the locking grooves  226  in spacer plate  214  to lock the suture clamping gate  216  in the closed position. Suture clamping gate  216  can further include a pair of lock tab actuator apertures  228 . 
       FIGS. 5A-5B  depict a suture crimp holder  250  according to an embodiment. Suture crimp holder  250  can include a pull rod  252  and a pair of lock tab actuator rods  254  extending between a front plate  256  and a back plate  258 . Referring now to  FIG. 6 , crimp holder  250  is sized to receive the suture crimp  200  between the front plate  256  and back plate  258  of the crimp holder  250 . Lock tab actuators  254  of crimp holder  250  (see  FIG. 5B ) are initially inserted through actuation slots defined by slots  210 ,  212  in front plate  202  and back plate  204  and into lock tab actuator apertures  228  of suture crimp  200  (See  FIG. 4B ) to interface crimp holder  250  with suture crimp  200  in the open position as depicted in  FIG. 7A . The suture clamping gate  216  is moved to the closed position by further moving the crimp holder  250  attached to the suture clamping gate  216  to pull the suture clamping gate  216  within the suture crimp  200 . When the suture locking tabs  224  reach the locking grooves  226 , the suture locking tabs  224  lock the suture locking gate  216  in the closed position clamping the suture. In an embodiment, suture locking gate  216  slides freely within suture crimp  200  until suture locking tabs  224  are disposed adjacent grooves  226 , and then an additional amount of force can cause suture locking tabs  224  to deflect and move passed grooves  226  and then deflect back to nest in grooves  226 . In some embodiments, crimp holder causes tabs to plastically deform into grooves. The crimp holder  250  can then slide back out of the slots  210 ,  212  of the suture crimp  200  to disengage the crimp holder  250  leaving the suture clamping gate  216  in the closed position. 
       FIGS. 8-10  depict the interaction of a delivery catheter  300  than can be used to deliver and actuate a suture crimp  200  according to an embodiment. The distal tip  302  of delivery catheter  300  is sized to hold crimp holder  250  and suture crimp  200 . In one embodiment, distal tip  302  includes crimp holder ends  304  that define an opening  306  sized to hold suture crimp  200  and crimp holder  250 . As can be seen in  FIG. 10  (shown without distal tip for sake of clarity), an actuation wire  350  extends through delivery catheter  300  and is looped around the pull rod  252  of crimp holder  250 . The crimp holder  250  can therefore be actuated to move the suture clamping gate  216  from the open position to the closed position as described above by pulling proximally on the actuation wire  350  from outside of the body. Once the suture clamping gate  216  is locked in the closed position the actuation wire  350  can pull the lock tab actuators  254  out of the slots  228  in the suture crimp  200  to remove the crimp holder  250  from the suture crimp  200 , leaving the suture crimp  200  in place on the leaflet. Any remaining suture on the opposite side of the crimp from the attached tissue can then be cut and removed. In embodiments, the delivery catheter is a separate device used to deliver the suture crimp and is not the same device as is used to insert the sutures. 
       FIG. 20  depicts a suture crimp  200 A according to another embodiment. Crimp  200 A is substantially similar to suture crimp  200 . However, in this embodiment suture crimp  200 A is configured to be delivered into the heart and actuated without use of crimp holder  250 . Instead, suture crimp  200  is actuated with a pair of actuation wires  352 . Each actuation wire  352  can extend through a delivery catheter and the actuation slots in crimp to be positioned within one of the actuation slots  228  of the suture clamping gate  216  such that pulling on the wires from outside the body will actuate the suture clamping gate  216  to crimp sutures extending through suture apertures  206 . Once the suture clamping gate has been pulled all the way upwardly, the force of the actuation wires on the suture locking tabs  224  can help the tabs to plastically deform and nest into the locking grooves  226 . Further force on the actuation wires  352  can remove the wires from the suture crimp  200  leaving the crimp locked on the sutures. In another embodiment, the pair of actuation wires  352  are not extended through the delivery catheter, but are instead operably interfaced proximal to the suture crimp  200  with a single actuation wire  350  similar to that shown in  FIG. 10  that extends through the catheter. In other similar embodiments, the pair of actuation wires  352  are interfaced with a single set of actuation wires in place of a single actuation wire  350 . 
       FIGS. 19A-19C  schematically depict insertion of a suture crimp such as suture crimp  200  or  200 A into the body. First  18 A and second  18 B sutures are inserted through first  16 A and second  16 B leaflets and the free ends  21 A,  21 B of each suture  18 A,  18 B are inserted through the crimp  200 . Once the sutures  18 A,  18 B have been adjusted to a tension that achieves desired leaflet  16 A,  16 B function, the crimp  200  is actuated in one of the manners set forth above to clamp the sutures at the desired tension. The suture ends  21 A,  21 B of each suture  18 A,  18 B can then be severed adjacent the crimp  200  with an appropriate cutting tool with the crimp  200  remaining in the body locked to the leaflets  16 A,  16 B by the sutures  18 A,  18 B to correct valve function. Applicant has conducted studies utilizing an embodiment of a crimp suture as described herein. As shown in the sequence of endoscopic images presented in  FIGS. 21A-21D and 25A-25D , it will be apparent to a person skilled in the art that use of such crimps in the manner described herein to repair valve function can provide a significant reduction in mitral valve regurgitation. 
     Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions. 
     Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. 
     Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. 
     Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. 
     For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.