Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 61/737,418, filed Dec. 14, 2012. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    This document relates generally to medical devices and particularly to a system and method for treating mitral valve regurgitation of all etiologies, and particularly degenerative mitral regurgitation due to leaflet prolapse caused by ruptured (flail) or elongated chordae tendineae. 
         [0004]    2. Background Information 
         [0005]    The mitral valve controls blood flow between the receiving and ejecting chambers of the left side of the heart, i.e., the left atrium and left ventricle. With each heartbeat, the atrium contracts to push blood into the ventricle. The leaflets of the mitral valve open to let the blood through. A properly functioning mitral valve allows blood to flow from the left atrium into the left ventricle, but not the other way. The mitral valve consists of two leaflets (anterior and posterior) attached to a fibrous ring or annulus. When the ventricle contracts to pump the blood out of the heart, the leaflets of the mitral valve close and create one of the highest pressure chambers in the body. In a healthy heart, the mitral valve leaflets overlap during contraction of the left ventricle to form a tight seal that prevents blood from flowing back into the atrium. 
       SUMMARY 
       [0006]    This document provides devices and methods for repairing a prolapsing mitral valve leaflet using minimally invasive catheter based approaches. The procedures generally involve a percutaneous “foldoplasty,” where a segment of a prolapsing leaflet is folded/pulled onto the atrial or ventricular surface of the greater mitral valve leaflet and secured. This procedure can include the following general steps. A prolapsing posterior leaflet can be approached using a minimally invasive and/or catheter-based approach. In some cases, the leaflet can be pierced to orient the grasping device. The prolapsing segment of the leaflet is captured. The prolapsing segment of the leaflet can be repositioned so as to support it and reduce or eliminate regurgitation. The prolapsing segment of the leaflet can be secured into the repositioned configuration. In some cases, an artificial chordae can be installed to further stabilize/support the leaflet. 
         [0007]    In general, one aspect of this document features methods for treating mitral valve prolapse of a mammal. A method for treating mitral valve prolapse of a mammal comprises forming a channel through at least a portion of a mitral valve leaflet, and feeding at least a portion of the mitral valve leaflet through the channel. The method can include securing the portion of the mitral valve leaflet to other cardiac structures utilizing sutures, screws, anchors, and the like. 
         [0008]    The foregoing and other embodiments can each optionally include one or more of the following features, alone or in combination. The mammal may be a human. The channel may extend from an atrial side surface of the mitral valve to a ventricle side surface of the mitral valve. A device comprising a grasper may be used to form the channel. The device may be extended through the channel and the grasper may be used to grasp an edge of the mitral valve. The device may be withdrawn from the channel while the grasper is grasping the edge of the mitral valve, and an anchor may be used to position or retain the edge of the mitral valve leaflet in relation to the channel. The anchor may be a suture or a clip device. In general, another aspect of this document features a method for treating mitral valve prolapse comprising approaching a prolapsed leaflet using a minimally invasive catheter technique, capturing a segment of the prolapsed leaflet using a grasping device, repositioning the segment on or against another portion of the prolapsed leaflet, and securing the segment to the other portion of the prolapsed leaflet using an attachment device. In some embodiments, the mitral valve leaflet may be constrained in a folded configuration as a result of applying the anchor. 
         [0009]    In general, another aspect of this document features a method for treating mitral valve prolapse comprising approaching a prolapsed leaflet using a minimally invasive catheter technique, piercing the prolapsed leaflet using an anchor device, securing a first end of the anchor device to the prolapsed leaflet, applying tension to the anchor device, and securing a second end of the anchor device to the prolapsed leaflet. In some embodiments, the mitral valve leaflet may be constrained in a folded configuration as a result of as a result of the securing the segment using the attachment device. 
         [0010]    In general, another aspect of this document features a method for treating mitral valve prolapse comprising approaching a prolapsed leaflet using a minimally invasive catheter technique, piercing the prolapsed leaflet using an anchor device, securing a first end of the anchor device to the prolapsed leaflet, applying tension to the anchor device, and securing a second end of the anchor device to a non-mitral valve area. In some embodiments, the prolapsed leaflet may be constrained in a folded configuration as a result of the securing the first and second ends of the anchor device to the prolapsed leaflet. 
         [0011]    In general, another aspect of this document features a method for treating mitral valve prolapse comprising approaching, using a minimally invasive catheter technique, a prolapsed mitral valve leaflet via an interatrial septum or interventricular septum of the heart, applying a clip onto the prolapsed leaflet, wherein an edge of the prolapsed mitral valve leaflet is constrained in a folded configuration as a result of applying the clip, and wherein an artificial chordae is attached at a first end to the clip, and anchoring a second end of the artificial chordae to an area of the heart. 
         [0012]    The foregoing and other embodiments can each optionally include one or more of the following features, alone or in combination. The tension of the artificial chordae may be adjusted while monitoring one or more characteristics of the heart such as a level of regurgitation of the mitral valve. Optionally, the clip may be a two-piece clip. In some embodiments, the method can further comprise attaching a first end of a second artificial chordae to the clip and attaching a second end of the second artificial chordae to another area of the heart. 
         [0013]    Particular embodiments of the subject matter described in this specification can be implemented so as to realize one or more of the following advantages. In some embodiments, prolapsed mitral valve leaflets can be treated using minimally invasive treatment techniques. As such, surgery risks in comparison to open-chest surgery can be mitigated; patient recovery and dismissal from hospital can be expedited; and risks of complications such as secondary infections can be reduced. Patients who are not candidates for open-chest surgery due to the associated risks may be able to receive treatment for a prolapsing mitral valve condition using the systems and techniques provided herein. Early quality of life and return to work can be improved following minimally invasive mitral valve repair. The personal and societal cost associated with this therapy may be more favorable due to resumption of normal daily activities and employment within a short period of time following percutaneous mitral valve repair. 
         [0014]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. 
         [0015]    The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a schematic cross-section of a heart with a close-up view of the mitral valve leaflets. 
           [0017]      FIGS. 2A-2F  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with one example embodiment. 
           [0018]      FIGS. 3A-3D  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0019]      FIGS. 4A-4B  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0020]      FIGS. 5A-5C  are a series of figures illustrating an example anchor device and anchoring technique. 
           [0021]      FIGS. 6A-6C  are a series of figures illustrating another example anchor device and anchoring technique. 
           [0022]      FIGS. 7A-7B  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0023]      FIGS. 8A-8B  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0024]      FIGS. 9A-9C  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0025]      FIGS. 10A-10C  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0026]      FIGS. 11A-11F  are a series of figures illustrating systems and methods of treating mitral valve prolapse in accordance with other example embodiments. 
           [0027]      FIGS. 12A and 12B  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0028]      FIGS. 13A-13D  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0029]      FIGS. 14A and 14B  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0030]      FIGS. 15A and 15B  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0031]      FIGS. 16A-16C  are a series of figures illustrating a system and method of treating mitral valve prolapse in accordance with another example embodiment. 
           [0032]      FIG. 17  is a flowchart describing a method of treating mitral valve prolapse using the systems provided herein. 
       
    
    
       [0033]    Like reference numbers and designations in the various drawings indicate like elements. 
       DETAILED DESCRIPTION 
       [0034]    As shown in  FIG. 1 , a heart  10  has multiple chambers including a left atrium  20  and a left ventricle  30 . The mitral valve  40  separates the left atrium  20  and left ventricle  30 . The mitral valve  40  includes a first (posterior) leaflet  42  and a second (anterior) leaflet  44 , that are both attached to a peripheral fibrous skeleton of the heart known as the mitral valve annulus  46 . 
         [0035]    In a healthy heart, the leaflets  42  and  44  of the mitral valve  40  close the valve opening when the left ventricle  30  contracts. In such a case, blood from left ventricle  30  will be expelled from left ventricle  30  via aortic valve  50  to aorta  60 . From aorta  60 , blood will be supplied to parts of the body. 
         [0036]    In some cases, leaflet  42  or  44  of mitral valve  40  or the chordae tendineae anchoring the leaflets to the papillary muscles can become floppy, elongated or rupture (flail chordae), leading to subluxation of the leaflets  42  or  44  past the annular plane during ventricular contraction, which can be referred to as mitral valve prolapse (MVP). When MVP exists, leaflets  42  and  44  of mitral valve  40  do not seal tightly. As a result, when left ventricle  30  contracts, a portion of blood from left ventricle  30  will flow backward into left atrium  20 . This is known as mitral regurgitation. Regurgitation can result in heart enlargement, congestive heart failure (shortness of breath, chest pain, and edema), atrial fibrillation (irregular heartbeats), pulmonary hypertension (elevated pressure in the lungs), and death. International heart valve consensus statements recommend correction of mitral valve prolapse and elimination of mitral regurgitation before symptoms develop. Many patients delay surgery to avoid open chest surgery, post-operative complications, and the necessary six to eight weeks of postoperative recovery. Decreasing the invasiveness of MVP correction to decrease mitral regurgitation is a sought-after therapy that may save lives. 
         [0037]      FIGS. 2A-2F  illustrate example devices and a series of steps for an example method of treating MVP. The procedure generally involves a percutaneous “foldoplasty,” where the redundant prolapsing segment of the prolapsing leaflet is folded or pulled down onto the ventricular or atrial surface of the mitral valve leaflet body and secured. The procedure uses a medical device system  200 , which can be delivered percutaneously to the site of mitral valve  40 . 
         [0038]    In  FIG. 2A , a schematic of a mitral valve  40  is illustrated with its two leaflets  42  and  44 . In this example, leaflet  42  is depicted as having a prolapse. Also shown is a medical device system  200  for treating the MVP. In some embodiments, medical device system  200  can approach the site of mitral valve  40  by being directed through the right atrium and into the left atrium. In some embodiments, medical device system  200  can approach the site of mitral valve  40  left ventricle (such as through the left ventricular apex) to the mitral valve site. In some embodiments, medical device system  200  can approach the site of mitral valve  40  by being directed through the right ventricle and into the left ventricle. In some embodiments, medical device system  200  can approach the site of mitral valve  40  by being directed through the aortic valve and left ventricular outflow tract and into the left ventricle. In some embodiments, medical device system can approach the site of the mitral valve  40  through the atrioventricular septum. In some embodiments, any other suitable mitral valve access path can be used. In some embodiments, a combination of such approach techniques can be used. The procedure can be performed, for example, using ultrasound visualization and/or x-ray visualization. In some embodiments, the procedure can be performed using assistance from robotics. 
         [0039]    In some embodiments, medical device system  200  can include an introducer catheter  210 . Introducer catheter  210  can have one or more lumens. In some embodiments, introducer catheter  210  can be steerable and/or exchangeable to aid in insertion and positioning of medical device system  200 . Introducer catheter  210  can include a sharp-pointed distal tip (or exchangeable puncturing tip)  212  that can be used to puncture tissue such as the atrial septum and leaflet  42 . In some cases, medical device system  200  can include two or more separate catheters or instruments. 
         [0040]    As shown in  FIG. 2A , in some embodiments medical device system  200  can puncture through leaflet  42  from one side of the leaflet, such that distal tip  212  of medical device system  200  is positioned on an opposite side of leaflet  42  in comparison to more the proximal portions of medical device system  200 . For example, distal tip  212  of introducer catheter  210  can puncture through leaflet  42  from the top at a puncture point  46 , such that distal tip  212  is positioned below leaflet  42 , or vice versa. However, in some embodiments, the procedure can be performed without puncturing leaflet  42 . 
         [0041]    A second device, such as a grasping device  220  can be deployed to the area of mitral valve  40 . In some cases, grasping device  220  can be located in a lumen of introducer catheter  210 . In some cases, grasping device  220  can be introduced into the area of mitral valve  40  without the use of a catheter to guide it. Grasping device  220  can be any of a variety of different types of devices. For example, grasping device  220  can be straight forceps, a directional forceps, a reverse forceps, a vacuum device, a thermal device (ice or heat “welding”), and the like. In this specification, grasping device  220  may alternately be referred to as a “forceps,” without limiting the types of grasping devices that are within the scope of the disclosure. 
         [0042]    As shown in  FIG. 2B , grasping device  220  can capture a prolapsing segment of leaflet  42 . For example, a forceps device  220  can pinch and firmly hold a prolapsing portion  48  of leaflet  42 . 
         [0043]    As shown in  FIG. 2C , medical device system  200  can be retracted from the previous position at which grasping device  220  captured prolapsing portion  48 , to a position at which prolapsing portion  48  is protruding through puncture point  46 . Retracting medical device system  200  while prolapsed portion  48  is captured in grasping device  220  can pull prolapsing portion  48  through tunnel  45  in leaflet  42  that was created by the puncturing of leaflet  42  by medical device system  200 . In this manner, prolapsed portion  48  of leaflet  42  can be folded onto greater leaflet  42 . In some embodiments, the folding can be performed without pulling prolapsed portion  48  through tunnel  45  in leaflet  42 . Rather, for example, prolapsed portion  48  can be folded using the space between leaflets  42  and  44 . In either case, at least a segment of prolapsed “tip” portion  48  can be positioned on the “body” or greater portion of leaflet  42 . 
         [0044]    As shown in  FIG. 2D , another instrument of medical device system  200  can be introduced to mitral valve  40  area to secure prolapsed portion  48  to greater leaflet  42 . For example, one or more suture loops  230  can be used to secure prolapsed portion  48  in position near puncture point  46 . In other embodiments, other devices and methods of securing prolapsed portion  48  to leaflet  42  can be used. For example, in some embodiments, prolapsed portion  48  can be sutured to leaflet  42  using a variety of techniques. In some embodiments, a locking or anchoring element can be used, such as a suture clip. In some embodiments, a pledget can also be utilized to increase the area over which the force from the folded prolapsed leaflet portion is distributed, thereby increasing the holding capacity resulting from the securing procedure. For example, a polymer pledget can be used in some cases. 
         [0045]      FIG. 2E  depicts leaflets  42  and  44  of mitral valve  40  at the completion of the procedure. Leaflet  42  that had prolapsed portion  48  is shown as being folded onto itself. Prolapsed portion  48  of leaflet  42  is secured to the body of greater leaflet  42  by use of a securing technique such as a suture loop  232 . In some cases, a pledget can be installed in between suture loop  232  and leaflet  42 . In this manner, prolapsed portion  48  has been stabilized such that leaflet  42  can present a reconfigured and reinforced edge to interface with the other leaflet  44 , apposing to each other at the plane of the mitral annulus, thereby eliminating MVP and mitral regurgitation. 
         [0046]      FIG. 2F  also depicts leaflets  42  and  44  of mitral valve  40  at the completion of the procedure. Leaflet  42  that had prolapsed portion  48  is shown as being folded onto itself. Prolapsed portion  48  of leaflet  42  is secured to greater leaflet  42  by use of a suture  234  securing technique. In other embodiments, other securing devices and techniques can be used such as suture clips, pledgets, and other types of anchors. 
         [0047]      FIG. 3A  illustrates another example of a type of medical device system  300  for treating a prolapsing leaflet  42 . In this example, medical device system  300  includes a reverse or backbiting forceps  320 . As shown, in some embodiments, reverse forceps  320  can be placed at the site of mitral valve  40  using an introducer catheter  310 . In some cases, introducer catheter  310  may have multiple lumens that can be used for multiple devices or other purposes, such as visualization. Medical device system  300  can be routed to the site of mitral valve  40  in a number of paths as described above. 
         [0048]    In some embodiments, introducer catheter  310  can include a sharp pointed distal tip  312  that can puncture tissue, such as atrial/ventricular walls of the heart (interatrial/interventricular or atrioventricular septums) and the leaflet of a mitral valve  40 . For example, as shown in  FIG. 3A , distal tip  312  can pierce leaflet  42  at a puncture point  46 , and be pushed all the way through leaflet  42  to create a tunnel  45  through the leaflet—thereafter distal tip  312  of catheter  310  being positioned on the ventricular side of leaflet  42  that is opposite of puncture point  46 . After the formation of tunnel  45 , a grasping device can be inserted through a lumen of introducer catheter  310 . As shown, the grasping device can include a reverse forceps  320 , as well as other types of grasping devices as described above. 
         [0049]    As shown in  FIG. 3B , grasping device  320  can capture prolapsed tip portion  48 . For example, reverse forceps  320  can pinch and hold prolapsed portion  48  to capture it. An intermediate assessment can be performed with various imaging modalities including echocardiogram, ventriculogram, CT, MRI, etc. Repositioning would therefore be facilitated at this stage to ensure optimal leaflet capture of the prolapsing leaflet tip  48 . Once reverse forceps  320  have grasped prolapsed portion  48 , the step of partially withdrawing medical device system  300  can be performed. 
         [0050]      FIG. 3C  depicts medical device system  300  and leaflets  42  and  44  after medical device system  300  has been withdrawn through tunnel  45  in leaflet  42 . In addition, prolapsed portion  48  has also been pulled through tunnel  45  so as to fold leaflet  42  onto itself. In this position, prolapsed portion  48  is ready to be secured by medical device system  300  to greater leaflet  42 . 
         [0051]      FIG. 3D  depicts the step of securing the prolapsed portion  48  to greater leaflet  42 . A securing device  330  can be deployed to the site of the folded leaflet  42  to perform the task of securing the prolapsed portion  48  to greater leaflet  42 . For example, as shown, the securing task can be performed by a suture loop  330 . As described above, a variety of other devices and techniques can be used for securing the prolapsed portion  48  to greater leaflet  42 . In some embodiments, supplemental devices such as clips, pledgets, nitinol discs, and various anchoring devices can be deployed for the securing procedure. 
         [0052]      FIGS. 4A-4B  illustrate a system  400  and method of treating mitral valve  40  prolapse in accordance with another example embodiment. Mitral valve  40  includes leaflets  42  and  44  as described above. Leaflet  42  is depicted as having a prolapse. 
         [0053]    In  FIG. 4A , a medical device system  400  is introduced to the site of mitral valve  40 . The route of medical device system  400  can be any of the routes as described above. Medical device system  400  can include a first catheter  410 , a second catheter  420 , and an anchoring device  430 . 
         [0054]    First catheter  410  and second catheter  420  can be conjoined in a telescoping manner. For example, second catheter  420  can be smaller than first catheter  410  such that second catheter  420  can be at least partially positioned inside of a lumen of first catheter  410 . In some embodiments, second catheter  420  can puncture leaflet  42  at puncture point  46 . By pushing second catheter  420  through leaflet  42 , a tunnel  45  can be formed through leaflet  42 . However, in some embodiments, catheters  410  and  420  may not puncture the leaflets. 
         [0055]    Anchor device  430 , for example, can be a wire or a suture material. Anchor device  430  can be routed through the lumens of both first catheter  410  and second catheter  420 . Anchor device  430  can include a distal end anchor  432 . Distal end anchor  432  can be configured with a sharp point to pierce leaflet  42  (as described further below in reference to  FIGS. 5A-5C  and  6 A- 6 C). As shown in  FIG. 4A , anchor device  430  can pierce all the way through leaflet  42 . In such a case, distal end anchor  432  can be positioned on the opposite side of leaflet  42  as compared to the rest of anchor device  430 . 
         [0056]      FIG. 4B  depicts anchor device  430  in place on leaflet  42  after the removal of medical device system  400 . To achieve this arrangement, second catheter  420  can be removed from tunnel  45  in leaflet  42 . However, anchor device  430  can remain in tunnel  45  and in catheters  410  and  420 . Next, a proximal anchor member  434  can be installed around anchor device  430  in a position in relation to leaflet  42  so that anchor device  430  is in tension, and distal end anchor  432  can retract prolapsed leaflet  42  into a less distended configuration. With proximal anchor member  434  in place, anchor device  430  can be cut at a location proximal to proximal anchor member  434  so as to result in the arrangement shown. 
         [0057]      FIGS. 5A-5C  illustrate an example anchor device  500  that can be used as part of a medical device system for performing the mitral valve leaflet anchoring techniques provided herein. The anchor device generally includes an elongate element  510 , a first barb  520 , and a second barb  530 , with barbs  520  and  530  being at the distal end of anchor device  500 . In some embodiments, barbs  520  and  530  can be hinged to pivot on elongate element  510 . Anchor device  500  can thereby include two or more configurations. For example, anchoring device  500  can include a piercing configuration and a deployed or anchoring configuration. 
         [0058]    As shown in  FIG. 5A , anchor device  500  can be presented to leaflet  42  so that it is poised to pierce leaflet  42 . At this stage, anchoring device  500  can be in the piercing configuration. As such, both barbs  510  and  520  are retracted, and the distal end of anchor device  500  resembles an arrow head. 
         [0059]      FIG. 5B  shows anchor device  500  after having pierced through leaflet  42 . At this point, barbs  520  and  530  can be extended as indicated by arrows  525  and  535 . 
         [0060]      FIG. 5C  depicts anchor device  500  with barbs  520  and  530  extended to provide a substantially flat surface to bear against the outer surface of leaflet  42 . For example, pulling on elongate element  510  can cause barbs  520 / 530  to reconfigure to their anchoring configuration. At this point, elongate element  510  of anchor device  500  can be pulled further so as to retract leaflet  42  into a desired position to treat the prolapse. 
         [0061]      FIGS. 6A-6C  illustrate another example anchor device  600  that can be used as part of a medical device system for performing a mitral valve leaflet anchoring technique provided herein. Anchor device  600  can generally include an elongate element  600  and a distal anchor  620 . Distal anchor  620  can be hinged on elongate element  610  so as to have multiple configurations, such as a piercing configuration and an anchoring configuration. 
         [0062]    In  FIG. 6A  anchor device  600  is positioned and configured to pierce leaflet  42 .  FIG. 6B  shows distal anchor  620  of anchor device  600  having pierced through leaflet  42 .  FIG. 6C  shows anchor device  600  after having tension applied to elongate element  610 . In this arrangement, distal anchor  620  is in the anchoring configuration, and leaflet  42  is retracted to treat the prolapse. 
         [0063]      FIGS. 7A-7B  illustrate another example medical device system  700  and method of treating mitral valve prolapse in accordance with another example embodiment. In general, medical device system  700  includes a first grasping device  710 , a suture device  720 , an introducer catheter  730 , and a second grasping device  740 . In this example, medical device system  700  is shown as treating a mitral valve  40  having leaflets  42  and  44 . Leaflet  42  is depicted as being in a prolapsed condition. Additionally, a papillary muscle  70  is included as part of this example technique for treating MVP. 
         [0064]    As shown in  FIG. 7A , a first grasping device  710  is placed between leaflets  42  and  44 . First grasping device  710  holds a suture device  720 , including a needle and an anchor thread  724  that can be a wire or another type of suitable material. First grasping device  710  can be used to pierce papillary muscle  70  with suture device  720 . Suture device  720  can be pushed through papillary muscle  70  such that at least the distal tip of the needle is protruding on the opposite side of papillary muscle  70 . 
         [0065]    An introducer catheter with a sharp distal tip  732  can be used to pierce leaflet  42  at a puncture site  46 , and to push all the way through the thickness of leaflet  42  as shown. A tunnel  45  is thereby created. At this point, a second grasper device  740  can be inserted through a lumen of introducer catheter  730  such that the distal operative grasping member of second grasper device  740  can capture the needle of suture device  720 . At this point, first grasper device  710  can release suture device  720 . Then introducer catheter  730  and second grasper device  740  can be withdrawn through tunnel  45  of leaflet  42 . In this manner, anchor thread  724  of suture device  720  can be pulled through tunnel  45 . 
         [0066]      FIG. 7B  depicts the final position of anchor thread  724 . As shown, anchor thread  724  is connected on one end to papillary muscle  70 , and to leaflet  42  on the other end, thereby creating an artificial chordae. Anchor members  726  and  728  abut papillary muscle  70  and leaflet  42 , respectively. These anchor members  726  and  728 , for example, can be of the types described above. As shown, with anchor thread  724  in tension, papillary muscle  70  is capable of applying a force via anchor thread  724  to leaflet  42  so as to treat the prolapse condition of leaflet  42 . 
         [0067]      FIGS. 8A-8B  illustrate another example medical device system  800  and method of treating mitral valve prolapse in accordance with another example embodiment. In general, this embodiment of an example medical device system  800  includes a catheter  810  and an anchor device  820 . Medical device system  800  can be used to treat some instances of MVP. For example, in some cases, a prolapsed leaflet  42  of a mitral valve  40  can be treated by folding the wall of leaflet  42  onto itself to create a portion that has a double-thickness of leaflet  42  tissue. 
         [0068]    As shown in  FIG. 8A , a catheter  810  can be positioned near leaflet  42 . An anchor device  820  can be made to extend from a lumen of catheter  810 . In some embodiments, anchor device  820  can include a distal anchor member  830 , such as those described in reference to  FIGS. 5A-5C  and  6 A- 6 C. As shown, anchor device  820  can be pushed through two layers of leaflet  42 . Distal anchor member  830  can be on the opposite side of the pierced side of the leaflet walls. Anchor thread  840  can be connected to distal anchor member  830  and located through two walls of leaflet  42 . 
         [0069]      FIG. 8B  illustrates the deployed configuration of anchor device  820 . As shown, distal anchor member  830  can be reconfigured to an anchoring configuration. A second anchor device  850  can be installed on the other end of anchor thread  840 . Second anchor device  850  can be a suture loop, a clip, a suture to attach to the leaflet, and so on as described above. Second anchor device  850  can be installed such that the anchor thread is in tension. Thus, the two layers of leaflet  42  can be pulled together as shown so as to treat the prolapse condition of leaflet  42 . 
         [0070]      FIGS. 9A-9C  illustrate a medical device system  900  and method of treating mitral valve prolapse in accordance with another example embodiment. This example is a method where a dual approach can be used to secure prolapsed leaflet  42  to the apex or ventricular septum of the left ventricle. In this method, a first catheter  910  approaches as per the embodiments provided herein, and pierces leaflet  42  with a wire anchor device  920  with a hook  922  at the distal end of wire anchor device  920 . A second catheter (not shown) is placed in the right ventricle or outside the apex of the left ventricle. The second catheter can place a capture wire  930  with a loop  932  into the left ventricle via the ventricular septum or apex of the left ventricle. The second catheter can position the wire at the bottom surface of leaflet  42  as shown. 
         [0071]    As depicted in  FIGS. 9B and 9C , wire loop  932  can capture hook  922 . Capture wire  930  can then pull wire anchor device  920  back to the left ventricular septal wall, or the wall of the apex. A suture with an anchoring element  940  can be attached to the proximal end of wire anchor device  920 . As wire anchor device  920  is pulled, wire  920  travels through leaflet  42  until anchoring element  940  stops at the surface of leaflet  42 . Capture wire  930  is pulled to final position at the left ventricular septum or left ventricle apex. Capture wire  930  can pull wire  920  to such a distal position, at which point a second anchoring element (not shown) can be installed to fix wire  920  in place. 
         [0072]    With reference to  FIGS. 10A-10C , a series of figures illustrate a system  1000  for treating a leaflet  42  with MVP in accordance with another example embodiment. The system  1000  performs a treatment including a foldoplasty and the installation of an artificial chordae. 
         [0073]    System  1000  includes a catheter  1010 , an artificial chordae  1020 , and a capture wire  1030 . Catheter  1010  can access the site of leaflet  42  using any suitable path as described above, e.g., via the intraatrial septum. Catheter  1010  can deliver artificial chordae  1020 . 
         [0074]    With reference to  FIG. 10A , an artificial chordae  1020  includes a piercing tip  1022 . In some embodiments, piercing tip  1022  can penetrate leaflet  42  twice so as to facilitate a foldoplasty technique where the redundant prolapsing segment of leaflet  42  is folded or pulled onto the ventricular or atrial surface of mitral valve leaflet  42  and secured. 
         [0075]    In some cases, a capture wire  1030  can approach mitral valve leaflet  42  from the opposite side as catheter  1010 . Capture wire  1020  can include a wire loop  1032  that can act as a lasso to capture and engage piercing tip  1022  as shown in  FIG. 10B . In some cases, capture wire  1030  can be passed through a septum such as the ventricular septum, and in some cases through a papillary muscle. Such anatomical structures can be used as anchorages for artificial chordae  1020 . With capture wire  1020  engaged with artificial chordae  1020 , capture wire  1030  can be pulled to draw artificial chordae  1020  through leaflet  42  and through the septum and/or papillary muscle anchorage location. 
         [0076]    With reference to  FIG. 10C , in some cases, a pair of pledgets  1040  and  1042  can be installed on folded leaflet  42  to contain leaflet  42  in the folded configuration. In some cases, sutures, clips, nitinol discs, and the like can be used rather than or in addition to pledgets. Artificial chordae  1020  can be anchored in a papillary muscle, septum, ventricular or atrial free wall, a combination of a papillary muscle and septum or wall, or any other suitable anatomical anchorage location. Artificial chordae  1020  can be cut to remove extra length. 
         [0077]    With reference to  FIGS. 11A-11F , this series of figures illustrate systems and methods of treating MVP in accordance with additional example embodiments. For example,  FIGS. 11A and 11B  illustrate a system  1100  including a catheter  1110  and a grasping device  1120 . Grasping device  1120  includes a first clip  1140  and a second clip  1142  that are releasably coupled to the jaws of grasping device  1120 . In some cases, grasping device  1120  can be introduced to the mitral valve via the left atrium and positioned such that closure of the jaws of grasping device  1120  will fold the prolapsed portion of leaflet  42 . 
         [0078]    As shown in  FIG. 11B , grasping device  1120  can be closed onto leaflet  42  to fold an edge of leaflet  42  on itself. The closure of grasping device  1120  can bring first clip  1140  into engagement with second clip  1142 . In some cases, first clip  1140  and second clip  1142  can couple to each other using a mechanical latching mechanism. For example, in some cases, one of the clips  1140  or  1142  can have one or more barbed projections and the other clip  1140  or  1142  can have complimentary receptacles in which the barbed projections can be locked. Any suitable coupling mechanism can be used to engage first clip  1140  to second clip  1142 . In some cases, sutures, screws, anchors, barbs and the like can be used instead of clips  1140  and  1142 . 
         [0079]    With reference to  FIG. 11D , first clip  1140  and second clip  1142  are shown in an engaged configuration on leaflet  42 . The configuration of first clip  1140  and second clip  1142  can be referred to herein as a “jawless clip.” That is, first clip  1140  and second clip  1142  do not include a hinge or jaw to couple them together. Therefore, the folded edge of posterior leaflet  42  that is presented to the anterior leaflet  44  can be free from obstructions related to the clip. In some cases, the use of this foldoplasty system and technique is the extent of the MVP treatment provided. In some cases, this foldoplasty system and technique can be augmented to include installation of artificial chordae as described herein. 
         [0080]    With reference to  FIG. 11C , another example system  1150  for performing a foldoplasty to treat MVP of a leaflet  42  is provided. System  1150  can include a catheter  1110  and a grasping device  1120 . Grasping device  1120  can include a first clip  1140  and a second clip  1142  that are releasably coupled to the jaws of grasping device  1120  as described herein. In some cases, grasping device  1120  can be introduced to the mitral valve via the left ventricle, and positioned such that closure of the jaws of grasping device  1120  will fold the prolapsed portion of leaflet  42 . 
         [0081]    In some cases, system  1150  can include a bending device  1154  delivered via catheter  1110 . Bending device  1154  can cooperate with grasping device  1120  to induce a fold in the prolapsed portion of leaflet  42  prior to or at the time of closure of grasping device  1120 . Bending device  1154  can have a blunt distal tip and can comprise any suitable material, e.g., nitinol, stainless steel, and polymeric materials. In some cases, bending device  1154  can be steerable. In some cases, a portion of bending device  1154  can remain implanted between the folds of leaflet  42 . In some cases, bending device  1154  can be removed from folded leaflet  42 . System  1150  can apply a jawless clip as shown in  FIG. 11D . 
         [0082]    With reference to  FIGS. 11E and 11F , jawless clips can include one or more artificial chordae  1160  and  1162 . In some cases, artificial chordae  1160  and  1162  can be sutures or wires. Artificial chordae  1160  and  1162  can be anchored to various areas of the heart so as to stabilize a mitral valve leaflet. 
         [0083]    With reference to  FIG. 11E , in some cases, a single artificial chordae  1160  can be attached to clip  1140  or  1142 . In some cases, artificial chordae  1160  can be pre-attached to clip  1140  or  1142  as delivered by grasping device  1120 . In some cases, artificial chordae  1160  can be attached to clip  1140  or  1142  after installation of the jawless clip. 
         [0084]    With reference to  FIG. 11F , in some cases, two artificial chordae  1160  and  1162  can be attached to clip  1140  or  1142 . As will be described further below in reference to  FIG. 15A , two artificial chordae  1160  and  1162  can be used to anchor to two different locations within the heart. 
         [0085]    With reference to  FIGS. 12A and 12B , a system  1200  for performing a foldoplasty to treat MVP of a leaflet  42  is provided. System  1200  can include a catheter  1210  and a grasping device  1220 . In some cases, grasping device  1220  can be introduced to the mitral valve via the left atrium (e.g., an intraatrial septum approach) and positioned such that closure of the jaws of grasping device  1220  will fold the prolapsed portion of leaflet  42 . In some cases, other suitable access paths can be utilized, e.g., via the aorta or intraventricular septum. In some cases, one jaw of grasping device  1220  can penetrate leaflet  42  as shown. 
         [0086]    In some cases, grasping device  1220  can include a first clip  1240  and a second clip  1242  that are releasably coupled to the jaws of grasping device  1220 , comprising a jawless clip as described herein. In some embodiments, the penetration of leaflet  42  by one jaw of grasping device  1220  can enable a clip with a hinged portion  1244  to be used without obstructing the interface between leaflets  42  and  44 . For example,  FIG. 12B  depicts a hinged clip  1246  installed on leaflet  42 . In some cases, such clips can include one or more artificial chordae. 
         [0087]    With reference to  FIGS. 13A-13D , a system  1300  for performing a foldoplasty to treat MVP of a leaflet  42  is provided. System  1300  can include a catheter  1310  and a grasping device  1320 . As shown in  FIG. 13A , in some cases, grasping device  1320  can approach the mitral valve via the left atrium (e.g., an intraatrial septum approach) and be positioned such that closure of the jaws of grasping device  1320  will fold the prolapsed portion of leaflet  42 . In some cases, other suitable approaches can be utilized, e.g., via the aorta or intraventricular septum. In some cases, one jaw of grasping device  1320  can penetrate leaflet  42  as shown in  FIG. 13C . 
         [0088]    In some cases, grasping device  1320  can include a first clip  1340  and a second clip  1342  that are releasably coupled to the jaws of grasping device  1320 , comprising a jawless clip as described above. In some embodiments, the penetration of leaflet  42  by one jaw of grasping device  1320  can enable a clip with a hinged portion  1344  to be used without obstructing the interface between leaflets  42  and  44 . For example,  FIG. 13D  depicts a hinged clip  1346  installed on leaflet  42 . In some cases, such clips can include one or more artificial chordae. 
         [0089]    With reference to  FIGS. 14A and 14B , a system  1400  for installing an artificial chordae is depicted. The artificial chordae can be attached to either or both of the anterior and posterior valve leaflets, and in any location thereon. Therefore, it should be understood that the figures are provided as examples of the techniques, and that such techniques can be applied to either or both leaflets. System  1400  can include a catheter  1410  and an artificial chordae  1420 . In some cases, an intraventricular septum approach by catheter  1410  can be used. In some cases, other suitable approaches can be used. In some cases, catheter  1410  can be advanced through a papillary muscle  70 . 
         [0090]    In some cases, artificial chordae  1420  can be used to pierce leaflet  44  and a distal end of artificial chordae  1420  can be attached to leaflet  44  using a first pledget  1430 , or a suture, clip, anchor, etc. as described above. In some cases, catheter  1410  can deliver a lasso device to couple with a pre-installed artificial chordae, such as an artificial chordae attached to a foldoplasty clip as described herein in reference to  FIGS. 11E and 11F . 
         [0091]    Catheter  1410  can be retracted to the right side of the heart, and a second pledget  1440  can be installed on the right ventricle side of the ventricular septum. Prior to finalizing the placement of the second pledget  1440 , the tension on artificial chordae  1420  can be optimized. To optimize the tension on artificial chordae  1420 , an intermediate assessment can be performed using various imaging modalities including echocardiogram, ventriculogram, CT, MRI, etc. to monitor regurgitation levels at various tensions. The desired tension of artificial chordae  1420  can be determined based on minimizing regurgitation. 
         [0092]    With reference to  FIGS. 15A and 15B , additional exemplary configurations of artificial chordae are provided. The artificial chordae can be attached to either or both of the anterior and posterior valve leaflets, and in any location thereon. Therefore, it should be understood that the figures are provided as examples of the techniques, and that such techniques can be applied to either or both leaflets. In  FIG. 15A , two artificial chordae  1520  and  1550  are attached to a foldoplasty clip  1530 . Artificial chordae  1520  can be routed through a first papillary muscle  70  and anchored on the wall of the right ventricle using a pledget  1540 . A second artificial chordae  1550  can be routed through a second papillary muscle  72  and anchored on the wall of the right ventricle using a pledget  1542 . 
         [0093]    In  FIG. 15B , a single artificial chordae  1550  is attached to leaflet  42  using a pledget  1544 , which could also be a foldoplasty clip, suture, anchor, barb, and so on. Artificial chordae  1550  can be routed through a papillary muscle  72 , then through another papillary muscle  70  and anchored on the wall of the right ventricle using a pledget  1542 . Any suitable anchorage location can be used, e.g., the left ventricle free wall or a papillary muscle. 
         [0094]    With reference to  FIGS. 16A-16C , a system  1600  for installing an artificial chordae  1620  using an atrioventricular septum approach is illustrated. The artificial chordae can be attached to either or both of the anterior and posterior valve leaflets, and in any location thereon. Therefore, it should be understood that the figures are provided as examples of the techniques, and that such techniques can be applied to either or both leaflets. System  1600  includes a catheter  1610  which can approach a mitral valve leaflet  44 . Artificial chordae  1620  can be attached to leaflet  44  using a clip  1630 , or a pledget, a nitinol disc, suture, or other suitable device. Catheter  1610  can be retracted such that the distal tip of catheter  1610  is in the right atrium. A second anchoring device, such as a pledget  1640 , can be installed on the wall of the atrioventricular septum in the right atrium. The tension on artificial chordae  1620  can be adjusted to minimize mitral valve regurgitation prior to the final placement of pledget  1640 . 
         [0095]    With reference to  FIG. 17 , an exemplary process  1700  for treating MVP is provided. Process  1700  can be performed in accordance with many of the systems and techniques described herein. 
         [0096]    At operation  1710 , a foldoplasty is performed. For example, systems and techniques such as those provided herein in reference to  FIGS. 2A-2F ,  3 A- 3 D,  4 A- 4 B,  11 A- 11 F,  12 A- 12 B, and  13 A- 13 D can be utilized for the foldoplasty procedure. In some cases, a clip can be installed to fold a prolapsed leaflet. In some cases, the clip can be a jawless clip. Various other devices and techniques, such as those described herein, can also be used to perform the foldoplasty. The technique can include the attachment of an artificial chordae to the leaflet. In some cases, the artificial chordae can be pre-attached to a clip used to perform the foldoplasty. 
         [0097]    At operation  1720 , an artificial chordae attached to the prolapsed leaflet is captured. For example, the artificial chordae can be captured by a forceps or by a lasso device. The device used to capture the artificial chordae can be located so as to enable the anchoring of the artificial chordae in the desired anatomical location. For example, if it is desired to attach the artificial chordae to a papillary muscle, the device used to capture the artificial chordae can be routed through the papillary muscle. In that case, when the device is retracted the artificial chordae will be pulled through the papillary muscle as desired. 
         [0098]    At operation  1730 , the tension of the artificial chordae is established. This operation can be performed by monitoring the regurgitation of the mitral valve while adjusting the tension of the artificial chordae. In some cases, the regurgitation can be monitored using various imaging modalities including echocardiogram, ventriculogram, CT, MRI, etc. to monitor regurgitation levels at various tensions. The tension of the artificial chordae can be established based on minimizing regurgitation. 
         [0099]    At operation  1740 , the artificial chordae can be anchored in the desired location to maintain the optimum tension of the artificial chordae. In some cases, the anchoring can be performed using a pledget on the opposite side of a septum. In some cases, an anchor device, such as a helical anchor, can be used to anchor the artificial chordae in tissue, such as the ventricular wall. 
         [0100]    In some cases, both anterior and posterior mitral valve leaflets can be repaired using the systems and methods provided herein. For example, a foldoplasty can be performed on one or both the anterior and posterior mitral valve leaflets. In some cases, artificial chordae can be installed for one or both the anterior and posterior mitral valve leaflets. 
         [0101]    While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination. 
         [0102]    Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various systems and components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated together in a product or packaged into multiple products. 
         [0103]    Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.

Technology Category: 1