US20130282059A1 - Methods, systems and devices for cardiac valve repair - Google Patents

Abstract

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a divisional of U.S. patent application Ser. No. 12/883,095 filed Sep. 15, 2010, which claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/243,459, filed Sep. 17, 2009. This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 11/349,742, filed on Feb. 7, 2006, which claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 60/650,918 entitled “Methods, Systems and Devices for Cardiac Valve Repair,” filed Feb. 7, 2005, and U.S. Provisional Patent Application Ser. No. 60/692,802 entitled “Methods, Systems and Devices for Cardiac Valve Repair,” filed Jun. 21, 2005. Priority of the aforementioned filing dates is hereby claimed, and the full disclosures of the aforementioned applications are hereby incorporated by reference in their entirety.
BACKGROUND
• The present invention relates generally to medical methods, devices, and systems. In particular, the present invention relates to methods, devices, and systems for the endovascular or minimally invasive surgical repair of the atrioventricular valves of the heart, particularly the mitral valve.
• Mitral valve regurgitation is characterized by retrograde flow from the left ventricle of a heart through an incompetent mitral valve into the left atrium. During a normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood back into the left atrium. In this way, the oxygenated blood is pumped into the aorta through the aortic valve. Regurgitation of the valve can significantly decrease the pumping efficiency of the heart, placing the patient at risk of severe, progressive heart failure.
• Mitral valve regurgitation can result from a number of different mechanical defects in the mitral valve. The valve leaflets, the valve chordae which connect the leaflets to the papillary muscles, or the papillary muscles themselves may be damaged or otherwise dysfunctional. Commonly, the valve annulus may be damaged, dilated, or weakened limiting the ability of the mitral valve to close adequately against the high pressures of the left ventricle. In some cases the mitral valve leaflets detach from the chordae tendinae, the structure that tethers them to the ventricular wall so that they are positioned to coapt or close against the other valve leaflet during systole. In this case, the leaflet “flails” or billows into the left atrium during systole instead of coapting or sealing against the neighboring leaflet allowing blood from the ventricle to surge into the left atrium during systole. In addition, mitral valve disease can include functional mitral valve disease which is usually characterized by the failure of the mitral valve leaflets to coapt due to an enlarged ventricle, or other impediment to the leaflets rising up far enough toward each other to close the gap or seal against each other during systole.
• The most common treatments for mitral valve regurgitation rely on valve replacement or strengthening of the valve annulus by implanting a mechanical support ring or other structure. The latter is generally referred to as valve annuloplasty. A recent technique for mitral valve repair which relies on suturing adjacent segments of the opposed valve leaflets together is referred to as the “bow-tie” or “edge-to-edge” technique. While all these techniques can be very effective, they usually rely on open heart surgery where the patient's chest is opened, typically via a sternotomy, and the patient placed on cardiopulmonary bypass. The need to both open the chest and place the patient on bypass is traumatic and has associated morbidity.
SUMMARY
• For the foregoing reasons, it would be desirable to provide alternative and additional methods, devices, and systems for performing the repair of mitral and other cardiac valves, including the tricuspid valve, which is the other atrioventricular valve. In some embodiments of the present invention, methods and devices may be deployed directly into the heart chambers via a trans-thoracic approach, utilizing a small incision in the chest wall, or the placement of a cannula or a port. In other embodiments, such methods, devices, and systems may not require open chest access and be capable of being performed endovascularly, i.e., using devices which are advanced to the heart from a point in the patient's vasculature remote from the heart. Still more preferably, the methods, devices, and systems should not require that the heart be bypassed, although the methods, devices, and systems should be useful with patients who are bypassed and/or whose heart may be temporarily stopped by drugs or other techniques. At least some of these objectives will be met by the inventions described hereinbelow.
• In an aspect, disclosed herein is a chordal replacement device having a proximal anchor including a flexible patch and a leaflet attachment device. The flexible patch is affixed to an upper surface of a portion of a flailing leaflet with the leaflet attachment device. The device also includes a distal anchor extending and affixed to a distal attachment site in a ventricle; and a flexible tether coupled to and tensioned between the proximal and distal anchors.
• In another aspect, there is a chordal replacement device having a proximal anchor including a flexible crimp clip having one or more barbs that embed into and affix to a portion of a flailing leaflet; a distal anchor extending and affixed to a distal attachment site in a ventricle; and a flexible tether coupled to and tensioned between the proximal and distal anchors.
• The device can include a leaflet attachment device having a pair of expandable elements interconnected by a central attachment rod. The pair of expandable elements can sandwich the flexible patch and the leaflet. The leaflet attachment device can include an expandable element. The expandable element can be self-deploying and can include a star-shaped barb, a mesh web, or a mesh ball. The proximal anchor can further include a mesh stent deployable within an atrium. The mesh stent can be coupled to a flexible rod that extends through a valve commissure into the ventricle. The distal end of the flexible rod can couple to the distal anchor and provide consistent tension on the tether during a heart cycle. The flexible rod can have a deflectable, spring-formed shape. The flexible rod can be jointed. The distal anchor and tensioned flexible tether can apply a downward force on the flailing leaflet. The distal anchor can include a weight, barb, adhesive, screw, or fluid-filled element. The distal attachment site can include a portion of the ventricle wall, ventricular septum or papillary muscle. The distal anchor can fine-tune the tension of the tether after the distal anchor is affixed to the distal attachment site. The distal anchor can include a coil screw and wherein rotation of the coil screw fine-tunes the tension on the tether. The distal anchor can include a balloon and wherein infusion of fluid into the balloon increases tension on the tether.
• The flexible tether can have a length that can be adjusted to a desired tension to apply a downward force on the flailing leaflet. The flexible tether can include one or more loops of a flexible material. The one or more loops can be drawn together at a distal end region with an enclosed element. The enclosed element can couple the one or more loops to the distal anchor. The one or more loops can be coupled to the proximal and distal anchors such that the one or more loops self-equalize and evenly distribute tension on the flailing leaflets and on distal attachment site.
• In another aspect, disclosed is a chordal replacement device including a proximal anchor comprising a flexible crimp clip having one or more barbs that embed into and affix to a portion of a flailing leaflet; a distal anchor extending and affixed to a distal attachment site in a ventricle; and a flexible tether coupled to and tensioned between the proximal and distal anchors.
• The distal anchor and flexible tether can hold down the flailing leaflet. The distal anchor can include a weight, barb, adhesive, screw, or fluid-filled element. The distal attachment site can include a portion of the ventricle wall, ventricular septum or papillary muscle. The distal anchor can fine-tune the tension of the tether after the distal anchor is affixed to the distal attachment site. The distal anchor can include a coil screw and wherein rotation of the coil screw fine-tunes the tension on the tether. The distal anchor can include a balloon and wherein infusion of fluid into the balloon increases tension on the tether. The tether can have a length that can be adjusted to a desired tension to hold the leaflet down.
• In another aspect, disclosed is a method for repairing a cardiac valve including accessing a patient's vasculature remote from the heart; advancing an interventional tool through an access sheath to a location near the cardiac valve, the interventional tool comprising a distal flange; affixing a chordal replacement device to a portion of a flailing leaflet, the chordal replacement device including a flexible patch; one or more leaflet attachment devices; a distal anchor; and a flexible tether coupled to and tensioned between the flexible patch and the distal anchor. The method also includes coupling the distal anchor to a distal attachment site in a ventricle; and applying a downward force on the flailing leaflet with the tether and distal anchor so as to prevent flail of the leaflet into the atrium.
• Affixing a chordal replacement device can further include positioning the flexible patch on an upper surface of a flailing leaflet, piercing the patch and the leaflet with the one or more leaflet attachment devices, and sandwiching the leaflet and the patch between a pair of expandable elements. The pair of expandable elements can be self-deploying. The distal anchor can include a weight, barb, adhesive, coil screw or fluid-filled element. The distal attachment site can include a portion of the ventricle wall, ventricular septum or papillary muscle. The method can further include observing flow through the cardiac valve to determine if leaflet flail, valve prolapse or valve regurgitation are inhibited. The method can further include adjusting tension of the tether coupled to and tensioned between the flexible patch and the distal anchor. The distal anchor can include a coil screw and wherein adjusting the tension of the tether comprises rotating the coil screw. The distal anchor can include a balloon and wherein adjusting the tension of the tether comprises infusing fluid into the balloon. The method can further include sensing contact between the distal anchor and the distal attachment site.
• Other features and advantages should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a schematic illustration of the left ventricle of a heart showing blood flow during systole with arrows.
• FIG. 1B shows a cross-sectional view of the heart wherein a flexible stent is positioned at or near the mitral valve.
• FIG. 2A shows a cross-sectional view of the heart showing one or more magnets positioned around the annulus of the mitral valve.
• FIG. 2B shows an annular band with magnets that can be positioned on the mitral valve annulus.
• FIG. 3 shows a cross-sectional view of the heart identifying locations for placement of valves.
• FIG. 4 show a cross-sectional view of the heart with a pair of flaps mounted at or near the mitral valve.
• FIG. 5A shows a schematic side view of the mitral valve leaflets with a flap positioned immediately below each leaflet.
• FIG. 5B shows a downward view of the mitral valve with a pair of exemplary flaps superimposed over the leaflets.
• FIG. 5C shows a pair of mitral valve leaflet flaps having complementary shapes.
• FIG. 6A shows a cross-sectional view of the heart with a membrane ring positioned at the mitral valve annulus.
• FIG. 6B shows a schematic view of the membrane ring, which includes an annular ring on which is mounted a membrane.
• FIG. 7A shows a cross-sectional view of a heart with a bladder device positioned partially within the left ventricle and partially within the left atrium.
• FIG. 7B shows a schematic side view of the mitral valve leaflets failing to coapt.
• FIG. 7C shows a schematic side view of the mitral valve leaflets with a bladder positioned between the leaflets.
• FIG. 7D shows a plan view of the mitral valve with the leaflets in an abnormal closure state such that a gap is present between the leaflets.
• FIG. 8 shows a cross-sectional view of the heart wherein a one-way valve device is located in the left atrium.
• FIG. 9A shows a prosthetic ring that is sized to fit within a mitral valve.
• FIG. 9B shows another embodiment of a prosthetic ring wherein a one-way valve is positioned inside the ring.
• FIG. 10 shows a prosthetic with one or more tongues or flaps that are configured to be positioned adjacent the flaps of the mitral valve.
• FIG. 11A shows an exemplary embodiment of one or more clips that are positioned on free edges of the leaflets.
• FIG. 11B shows pair of leaflets with a magnetic clip attached to the underside of each leaflet.
• FIG. 11C shows the leaflets coapted as a result of the magnetic attraction between the magnetic clips.
• FIG. 11D shows a pair of leaflets with a single clip attached to one of the leaflets.
• FIG. 12 shows a schematic, cross-sectional view of the heart with a wedge positioned below at least one of the leaflets of the mitral valve.
• FIG. 13A shows an artificial chordae tendon.
• FIGS. 13B and 13C show attachment devices for attaching the artificial chordae tendon to a heart wall.
• FIG. 14 shows a cross-sectional view of the heart with a first and second anchor attached to a wall of the heart.
• FIG. 15 shows a catheter that has been introduced into the heart.
• FIG. 16 shows a schematic view of a papillary muscle with a ring positioned over the muscle.
• FIG. 17 shows a cross-sectional view of the heart with one or more magnets attached to a wall of the left ventricle.
• FIG. 18A shows another embodiment of a procedure wherein magnets are implanted in the heart to geometrically reshape the annulus or the left ventricle.
• FIG. 18B shows the heart wherein tethered magnets are implanted in various locations to geometrically reshape the annulus or the left ventricle.
• FIG. 18C shows the heart wherein magnets are implanted in various locations to geometrically reshape the annulus or the left ventricle.
• FIG. 19 shows another embodiment of a procedure wherein magnets are implanted in the heart to geometrically reshape the annulus or the left ventricle.
• FIG. 20 shows a cross-sectional view of the left ventricle with a tether positioned therein.
• FIG. 21 shows a cross-sectional view of the left ventricle with a delivery catheter positioned therein.
• FIG. 22 shows a cross-sectional view of the left ventricle with the delivery catheter penetrating a wall of the left ventricle.
• FIG. 23 shows a cross-sectional view of the left ventricle with the delivery catheter delivering a patch to the wall of the left ventricle.
• FIG. 24 shows a cross-sectional view of the left ventricle with the delivery penetrating delivering a second patch.
• FIG. 25 shows a cross-sectional view of the left ventricle with two tethers attached together at opposite ends from the patches mounted in the heart.
• FIG. 26 shows a cross-sectional view of the left ventricle with a needle or delivery catheter passed transthoracically into the left ventricle LV to deliver a patch to the exterior of the ventricular wall.
• FIG. 27 shows a schematic, cross-sectional view of the left ventricle in a healthy state with the mitral valve closed.
• FIG. 28 shows the left ventricle in a dysfunctional state.
• FIG. 29 shows the left ventricle with a biasing member mounted between the papillary muscles.
• FIG. 30 shows the left ventricle with a suture mounted between the papillary muscles.
• FIG. 31 shows the left ventricle with a snare positioned around the chordae at or near the location where the chordae attach with the papillary muscles.
• FIG. 32 shows a leaflet grasping device that is configured to grasp and secure the leaflets of the mitral valve.
• FIGS. 33A-33C show the leaflet grasping device grasping leaflets of the mitral valve.
• FIG. 34 shows the left ventricle with a needle being advanced from the left atrium into the left ventricle via the leaflet grasping device.
• FIG. 35 shows the left ventricle with sutures holding the papillary muscles in a desired position.
• FIG. 36 shows a cross-sectional view of the heart with one or more clips clipped to each of the papillary muscles.
• FIG. 37 shows a cross-sectional view of the heart with tethered clips attached to opposed walls of the left ventricle.
• FIGS. 38A-38C show an embodiment of a chordal replacement device.
• FIGS. 39A-39M show another embodiment of a chordal replacement device.
• FIGS. 39N-39O show an embodiment of a dual function clamp and deployment of an embodiment of a chordal replacement device.
• FIGS. 40A-40B show another embodiment of a chordal replacement device.
• FIGS. 41A-41B show a cross-sectional view of the chordal replacement device ofFIGS. 40A-40B being deployed.
• FIGS. 41C-41E show an embodiment of an attachment device fixing a chordal replacement device to a valve leaflet.
• FIG. 41F shows an embodiment of an expandable feature of an attachment device having a star-shaped design.
• FIGS. 41G-41P show embodiments of a leaflet stabilizing mechanism.
• FIGS. 42A-42D show various embodiments of an expandable feature of an attachment device.
• FIGS. 43A-43B show an embodiment of attachment devices fixing a patch to a valve leaflet.
• FIGS. 44A-44D show various steps in the deployment of an embodiment of a chordal replacement device.
• FIGS. 45A-45D show various embodiments of a distal attachment assembly deployed in the ventricle wall.
• FIGS. 46A-46B show an embodiment of a sensor used in the adjustment of artificial chordae tension.
• FIG. 47 illustrates an embodiment of fine-tuning the tension on the artificial chordae.
• FIGS. 48A-48B illustrate another embodiment of fine-tuning the tension on the artificial chordae.
• FIGS. 49A-49B show another embodiment of an attachment assembly for a chordal replacement device.
• FIGS. 50A-50B show another embodiment of an attachment assembly for a chordal replacement device.
• FIGS. 50C-50E show an embodiment of a jointed rod having mechanical locking feature.
• FIG. 50F illustrates the independent pivot axes of a jointed rod system.
• FIGS. 51A-51B show another embodiment of an attachment assembly for a chordal replacement device.
• FIGS. 52A-52C show an embodiment of a leaflet extension device blocking valve leaflet flail.
DETAILED DESCRIPTION
• The present invention provides methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction (systole), most particularly the mitral valve between the left atrium and the left ventricle. By “endovascular,” it is meant that the procedure(s) of the present invention are performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously, i.e., through an access sheath, or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart. Thus, the procedures of the present invention will generally not require penetrations made directly through the exterior heart muscle, i.e., myocardium, although there may be some instances where penetrations will be made interior to the heart, e.g., through the interatrial septum to provide for a desired access route.
• While the procedures of the present invention will usually be percutaneous and intravascular, many of the tools will find use in minimally invasive and open surgical procedures as well that includes a surgical incision or port access through the heart wall. In particular, the tools for capturing the valve leaflets prior to attachment can find use in virtually any type of procedure for modifying cardiac valve function.
• The atrioventricular valves are located at the junctions of the atria and their respective ventricles. The atrioventricular valve between the right atrium and the right ventricle has three valve leaflets (cusps) and is referred to as the tricuspid or right atrioventricular valve. The atrioventricular valve between the left atrium and the left ventricle is a bicuspid valve having only two leaflets (cusps) and is generally referred to as the mitral valve. In both cases, the valve leaflets are connected to the base of the atrial chamber in a region referred to as the valve annulus, and the valve leaflets extend generally downwardly from the annulus into the associated ventricle. In this way, the valve leaflets open during diastole when the heart atria fill with blood, allowing the blood to pass into the ventricle.
• During systole, however, the valve leaflets are pushed together and closed to prevent back flow of blood into the atria. The lower ends of the valve leaflets are connected through tendon-like tissue structures called the chordae, which in turn are connected at their lower ends to the papillary muscles. Interventions according to the present invention may be directed at any one of the leaflets, chordae, annulus, or papillary muscles, or combinations thereof. It will be the general purpose of such interventions to modify the manner in which the valve leaflets coapt or close during systole so that back flow or regurgitation is minimized or prevented.
• The left ventricle LV of a normal heart H in systole is illustrated inFIG. 1A. The left ventricle LV is contracting and blood flows outwardly through the tricuspid (aortic) valve AV in the direction of the arrows. Back flow of blood or “regurgitation” through the mitral valve MV is prevented since the mitral valve is configured as a “check valve” which prevents back flow when pressure in the left ventricle is higher than that in the left atrium LA. The mitral valve MV comprises a pair of leaflets having free edges FE which meet evenly to close, as illustrated inFIG. 1A. The opposite ends of the leaflets LF are attached to the surrounding heart structure along an annular region referred to as the annulus AN. The free edges FE of the leaflets LF are secured to the lower portions of the left ventricle LV through chordae tendineae CT (referred to hereinafter as the chordae) which include plurality of branching tendons secured over the lower surfaces of each of the valve leaflets LF. The chordae CT in turn, are attached to the papillary muscles PM which extend upwardly from the lower portions of the left ventricle and interventricular septum IVS.
• While the procedures of the present invention will be most useful with the atrioventricular valves, at least some of the tools described hereinafter may be useful in the repair of other cardiac valves, such as peripheral valves or valves on the venous side of the cardiac circulation, or the aortic valve.
• The methods of the present invention can comprise accessing a patient's vasculature at a location remote from the heart, advancing an interventional tool through the vasculature to a ventricle and/or atrium, and engaging the tool against a tissue structure which forms or supports the atrioventricular valve. By engaging the tool against the tissue structure, the tissue structure is modified in a manner that reduces valve leakage or regurgitation during ventricular systole. The tissue structure may be any of one or more of the group consisting of the valve leaflets, chordae, the valve annulus, and the papillary muscles, atrial wall, ventricular wall or adjacent structures. Optionally, the interventional tool will be oriented relative to the atrioventricular valve and/or tissue structure prior to engaging the tool against the tissue structure. The interventional tool may be self-orienting (e.g., pre-shaped) or may include active mechanisms to steer, adjust, or otherwise position the tool.
• Alternatively, orientation of the interventional tool may be accomplished in whole or in part using a separate guide catheter, where the guide catheter may be pre-shaped and/or include active steering or other positioning means such as those devices set forth in United States Patent Publication Numbers 2004/0044350, 2004/0092962, and 2004/0087975, all of which are expressly incorporated by reference herein. In all cases, it will usually be desirable to confirm the position prior to engaging the valve leaflets or other tissue structures. Such orienting step may comprise positioning the tool relative to a line of coaptation in the atrioventricular valve, e.g., engaging positioning elements in the valve commissures and confirming the desired location using a variety of imaging means such as magnetic resonant imaging (MRI), intracardiac echocardiography (ICE), transesophageal echo (TEE), fluoroscopy, endoscopy, intravascular ultrasound (IVUS) and the like.
• In some embodiments, heart disease in general, and valve repair in particular, are treated by targeting the pacing of the heartbeat. In one embodiment, heart disease is treated by introducing one or more pacing leads into a heart chamber. The pacing leads are placed in contact with a heart muscle and are in electrical communication with a power source. The power source provides paced electrical stimuli to the heart muscle. The electrical stimuli are provided during or immediately after systole to extend systolic contraction of the heart, thereby extending the range of systole during each heartbeat. This extension of systole extends the amount of time in which the heart muscle tightens when it would otherwise be relaxing, when there is most mitral regurgitation in diseased mitral valves.
• Other embodiments are directed to annuloplasty to treat heart disease in general and valve repair in particular. In one embodiment, shown generally inFIG. 1B, a stent is used to treat the mitral valve.FIG. 1B shows a cross-sectional view of the heart wherein aflexible stent100 is positioned at or near the mitral valve MV. Thestent100 is annular and is sized and shaped to be positioned on the annulus of the mitral valve. Thestent100 can transition between a collapsed state of reduced size and an expanded state of enlarged size relative to the collapsed state.
• Theflexible stent100 can be percutaneously introduced into an individual's heart while being biased toward the collapsed state. The stent is advanced partially through the annulus of the mitral valve so that it is coaxially positioned within the annulus, as shown inFIG. 1B. Thestent100 is then secured to the annulus such that the stent exerts an inward force on the annulus thereby causing the annulus to resist dilation during diastole of the heart.
• In yet another embodiment, a device is disclosed for treating the mitral valve. The device can be a stent, such as thestent100, that is sized to fit coaxially within an annulus of a mitral valve. The stent includes a hollow frame. The frame can be annular such that it has a cross-sectional diameter that is sized such that an outer surface of the frame is in continuous coaxial contact with the annulus. The frame also includes one or more anchors protruding from it for securing the stent to the annulus. The anchors can be prongs, barbs, protrusions, or any structure adapted to secure the stent to the annulus. The stent is flexible between an expanded configuration and a contracted configuration and is biased toward the contracted configuration so that it exerts an inward force on the annulus.
• In one embodiment, thestent100 is delivered using adelivery catheter10 that is advanced from the inferior vena cava IVC into the right atrium RA. Once thecatheter10 reaches the anterior side of the interatrial septum IAS, aneedle12 may be advanced so that it penetrates through the septum at the fossa ovalis FO or the foramen ovale into the left atrium LA. At this point, a delivery device can be exchanged for the needle and the delivery device used to deliver thestent100. Thecatheter10 can also approach the heart in other manners.
• FIG. 2A shows a cross-sectional view of the heart showing one ormore magnets205 positioned around the annulus of the mitral valve MV. A corresponding method of treating heart disease involves the use of magnets. The method includes percutaneously introducing at least afirst magnet205 into an individual's heart and securing it to the mitral valve MV annulus. At least asecond magnet205 is percutaneously introduced into the heart and advanced so that it is within a magnetic field of the first magnet. The second magnet is secured to the heart. The polarity of one of the two magnets is then cyclically changed in synchronization with the heart beat so that the magnets attract and repel each other in synchronization with the heart beat. The first magnet therefore moves in relation to the second magnet and exerts an inward closing force on the mitral valve during systole. Themagnets205 can be positioned on an annular band215 (shown inFIG. 2B) that is sized and shaped to be implanted on the annulus of the mitral valve. Theband215 can be, for example, a stent.
• In one embodiment, themagnets205 or theannular band215 are delivered using adelivery catheter10 that is advanced from the inferior vena cava IVC into the right atrium RA, as described above with reference toFIG. 1. Any of the devices described herein can be percutaneously delivered into the heart by coupling the device to a delivery device, such as a steerable delivery catheter.
• In yet another embodiment involving magnets, two or more magnets are percutaneously introduced into an individual's coronary sinus such that they attract or repel each other to reshape the coronary sinus and an underlying mitral valve annulus.
• Other embodiments involve various prosthetics for treating heart disease in general and defective or diseased mitral valves in particular. In one embodiment, a method of treatment includes placing one or more one-way valves in one or more pulmonary veins of an individual either near the ostium of the vein or at some point along the length of the PV. Valves that may be used, for example may be stentless valves such as designs similar to the TORONTO SPV® (Stentless Porcine Valve) valve, mechanical or tissue heart valves or percutaneous heart valves as are known in the art provided they are sized appropriately to fit within the lumen of the pulmonary vein, as shown inFIG. 3. InFIG. 3, the locations in the left atrium LA where valves can be positioned in pulmonary vein orifices are represented by an “X”. In addition, certain venous valve devices and techniques may be employed such as those described in U.S. Pat. Nos. 6,299,637 and 6,585,761, and United States Patent Publication Numbers 2004/0215339 and 2005/0273160, the entire contents of which are incorporated herein by reference. A valve prosthesis for placement in the ostia of the pulmonary vein from the left atrium may be in the range of 6-20 mm in diameter. Placement of individual valves in the pulmonary vein ostia (where the pulmonary veins open or take off from the left atrium) may be achieved by obtaining trans septal access to the left atrium with a steerable catheter, positioning a guidewire through the catheter and into the targeted pulmonary vein, and deploying a valve delivery catheter over the guidewire and deploying the valve out of the delivery catheter. The valve may be formed of a deformable material, such as stainless steel, or of a self-expanding material such as NiTi, and include tissue leaflets or leaflets formed of a synthetic material, such as is known in the art. A line of +++++ symbols inFIG. 3 represents a mid-atrial location above the mitral valve where a single valve can be positioned as disclosed later in this specification.
• The following references, all of which are expressly incorporated by reference herein, describe devices (such as steerable catheters) and methods for delivering interventional devices to a target location within a body: United States Patent Publication Numbers 2004/0044350, 2004/0092962 and 2004/0087975.
• FIG. 4 show a cross-sectional view of the heart with a pair of flaps mounted at or near the mitral valve.FIG. 5A shows a schematic side view of the mitral valve leaflets LF with aflap300 positioned immediately below each leaflet. Theflap300 can be contoured so as to conform at least approximately to the shape of a leaflet, or theflap300 can be straight as shown inFIG. 4.FIG. 5B shows a downward view of the mitral valve with a pair of exemplary flaps superimposed over the leaflets LF. As shown inFIG. 5C, the flaps can have complementary shapes with a first flap having a protrusion that mates with a corresponding recess in a second flap.
• In corresponding method of treatment, shown inFIGS. 4 and 5C, afirst flap300 with anattachment end305 and afree end310 is provided. Theattachment end305 of thefirst flap300 is secured to the inside wall of the ventricle below the mitral valve. Asecond flap315 with anattachment end320 and afree end330 is provided and is also secured to the inside wall of the ventricle below the mitral valve. The first andsecond flaps300,315 are oriented so that they face each other and the free ends310,330 are biased toward each other and approximate against each other during systole. This system provides a redundant valving system to assist the function of the native mitral valve.
• In other embodiments, devices and methods that involve prosthetic discs are disclosed. For example,FIG. 6A shows a cross-sectional view of the heart with amembrane ring610 positioned at the mitral valve annulus.FIG. 6B shows a schematic view of themembrane ring610, which includes an annular ring on which is mounted a membrane. The membrane includes a series ofperforations615 extending through the membrane surface. One or more anchor devices, such as prongs, can be located on the ring for securing the ring to the mitral valve.
• In one embodiment, a device for treating heart disease in general and defective or diseased mitral valves in particular includes a disc having a ring, a membrane stretched across an opening of the ring, and one or more anchors for securing the disc to an annulus of a mitral valve. The disc is sized to cover the annulus of the mitral valve, and the membrane includes one or more perforations that permit one way fluid flow through the disc. Methods of treatment using the device are also provided.
• In other embodiments, devices and methods that involve fluid-filled bladders are disclosed.FIG. 7A shows a cross-sectional view of a heart with a bladder device positioned partially within the left ventricle and partially within the left atrium. A device for treating heart disease in general and defective or diseased mitral valves in particular includes a fluid-filledbladder600. Thebladder600 is placed across the mitral valve between the left atrium and the left ventricle. Upon compression of the left ventricle, the volume of the bladder is expanded on the left atrial side of the heart, providing a baffle or sealing volume to which the leaflets of the mitral valve coapt. The bladder may also act as a blocking device in the case of flail of a leaflet, blocking said flailing leaflet from billowing into the left atrium causing regurgitation. The bladder also includes one or more anchors for securing the bladder to an annulus of a mitral valve, or may be formed on a cage or other infrastructure to position it within the line of coaptation of the mitral valve.
• A bladder can also be used to treat functional mitral valve disease. As mentioned, functional mitral valve disease is usually characterized by the failure of the mitral valve leaflets to coapt due to an enlarged ventricle, or other impediment to the leaflets rising up far enough toward each other to close the gap or seal against each other during systole.FIG. 7B shows a schematic side view of the mitral valve leaflets LF failing to coapt such that regurgitation can occur (as represented by the arrow RF.) With reference toFIG. 7C, a baffle orbladder630 is positioned between the leaflets LF along the line of coaptation of the leaflets. Thebladder630 provides a surface against which at least a portion of the leaflets LF can seal against. Thebladder630 thus serves as a coaptation device for the leaflets. The bladder can be attached to various locations adjacent to or on the mitral valve.FIG. 7D shows a plan view of the mitral valve with the leaflets LF in an abnormal closure state such that a gap G is present between the leaflets. In one embodiment, the bladder is attached or anchored to the mitral valve at opposite edges E of the gap G.
• Methods of treatment using the bladder include providing the bladder and inserting it through an annulus of a mitral valve such that the bladder is coaxially positioned through the mitral valve. An atrial portion of the bladder extends into the left atrium, and a ventricular portion of the bladder extends into the left ventricle. A mid portion of the bladder may be secured to the annulus of the mitral valve such that the mid portion remains stationery while the atrial and ventricular portions expand and contract passively between the atrium and ventricle based on pressure differentials during systole and diastole.
• FIG. 8 shows a cross-sectional view of the heart wherein a one-way valve device700 is located in the left atrium. The valve device is represented schematically inFIG. 8. A corresponding method of treating heart disease includes introducing a one-way valve device700 into the left atrium of an individual's heart proximal the mitral valve. Thevalve device700 is configured to permit fluid flow in one direction while preventing fluid flow in an opposite direction. The valve device can have various structures. For example, the device can comprise a valve that is mounted on a stent that is sized to be positioned in the left atrium. Valves that may be used, for example may be stentless valves such as the TORONTO SPV® (Stentless Porcine Valve) valve, mechanical or tissue heart valves or percutaneous heart valves as are known in the art. The outer wall of the one-way valve device is sealed to the inner wall of the atrium so that a fluid-tight seal is formed between the outer wall of the one-way valve device and the inner wall of the left atrium. In this regard, the valve device can include a seal member that is configured to seal to the inner wall of the atrium.
• Another embodiment involves a prosthetic for treating heart disease in general and defective or diseased mitral valves in particular.FIG. 9A shows aprosthetic ring800 that is sized to fit within a mitral valve annulus The ring includes one ormore anchors805 that extend around the periphery of thering800. In addition, one ormore struts810 struts extend across the diameter of the ring, and can be made of a material that includes Nitinol or magnetic wires for selectively adjusting the shape of the ring. The struts can also be instrumental in baffling mitral valve leaflet “flail”.FIG. 9B shows another embodiment of aprosthetic ring807 wherein a one-way valve815 is positioned inside the ring such that blood flow BF can flow through the valve in only one direction. The valve can be manufactured of various materials, such as silicone.
• FIG. 10 shows a prosthetic with one or more tongues or flaps that are configured to be positioned adjacent the flaps of the mitral valve. The prosthetic includes aring900 sized to fit within a mitral valve annulus. At least twotongues910 project from thering900 in a caudal direction when the ring is implanted into a heart of an individual. The ring is flexible between an expanded configuration and a contracted configuration and is biased toward the contracted configuration. One ormore anchors920 protrude from the flexible ring for coupling the ring coaxially to the annulus such that the contracted configuration of the ring exerts an inward force to the annulus. Alternatively, or in addition, the two tongues can each have a length sufficient to prevent prolapse of a mitral valve when the ring is placed atop the leaflets of the mitral valve. In a further embodiment the tongue elements may be attached at a central point.
• In yet another embodiment, a prosthetic for treating heart disease in general and a defective or diseased mitral valve in particular includes a wedge. The wedge has a length that is about equal to a length of the line of coaptation of a mitral valve. The wedge has a depth sufficient to prevent prolapse of a mitral valve when the wedge is placed atop an annulus of the mitral valve along the line of coaptation, and may provide a point of coaptation for each leaflet. One or more anchors protrude from the wedge for coupling the wedge to the annulus of the mitral valve. Methods of treatment using the wedge are also disclosed. The methods include inserting the wedge into an individual's heart, placing the wedge lengthwise along the line of coaptation of the mitral valve. The wedge is then secured to an annulus of the mitral valve along the line of coaptation. The wedge may be positioned also just under one segment of the leaflet (likely P2 in the case of functional MR).
• In yet another embodiment, a device for treating heart disease includes a clip for attachment to a free end of a heart valve leaflet.FIG. 11A shows an exemplary embodiment of one ormore clips1101 that are positioned on free edges of the leaflets LF. Each of theclips1101 has a shape that prevents flail of the leaflet by catching against an underside of an opposing leaflet. Methods of treatment using the clip are also disclosed. The methods include introducing the clip into an individual's heart and attaching the clip to a free end of a heart valve leaflet opposite the free end of an opposing leaflet of the heart valve so that the clip catches to the underside of the opposing leaflet during systole. In a further embodiment, a clip may be placed on both leaflets such that the clips meet or catch when the leaflets are in proximity. The clips may attach momentarily during systole, and then detach during diastole, or may clip permanently resulting in a double orifice mitral valve anatomy. The clips of this embodiment may include a magnetic element, or one may be magnetic and the other of a metal material attracted to said electromagnetic field of the magnetic clip.
• In the case of magnetic clips, the clip elements may be placed on the underside of the leaflets (e.g. not necessarily on the free edge of the leaflet), provided that the magnetic field of the clip is sufficient to attract the opposing magnetic or metal clip element. This is further described with reference toFIG. 11B, which shows pair of leaflets LF with aclip1101 attached to the underside of each leaflet. At least one of the clips is magnetic, while the other clip is of an opposite magnetic polarity than the first clip or of a metal attracted to the magnetic field of the first clip. The magnetic field is sufficiently strong such that theclips1101 can attach to one another either momentarily or permanently to coapt the leaflets, as shown inFIG. 11C.
• In another embodiment, shown inFIG. 11D, asingle clip1101 is attached to one of the leaflets. Theclip1101 is sufficiently long to increase the likelihood that theclip1101 will coapt with the opposite leaflet.
• In yet another embodiment, a device for treating heart disease includes a wedge for placement under a heart valve leaflet.FIG. 12 shows a schematic, cross-sectional view of the heart with awedge1205 positioned below at least one of the leaflets of the mitral valve. Thewedge1205 can be positioned below one or both of the leaflets. Thewedge1205 is sized to fit under the valve leaflet and caudal the annulus of the heart valve. Thewedge1205 can have a shape that is contoured so as to provide support to a lower surface of the leaflet. (InFIG. 12, the left atrium is labeled LA and the left ventricle is labeled LV.) An anchor is attached to the wedge for coupling the wedge to a wall of the heart chamber adjacent the heart valve. The wedge forms a fixed backstop against the bottom side of the heart valve leaflet, thereby providing a location for the leaflet to coapt against, and/or providing support or “pushing up” a restricted leaflet.
• Other embodiments are directed to altering the size, shape, chemistry, stiffness, or other physical attributes of heart valve leaflets. In one embodiment in particular, a method of treating heart disease includes obtaining access to a heart valve leaflet and injecting a stiffening agent into the leaflet to stiffen the leaflet and minimize flail.
• Other embodiments are directed to the chordae that connect heart valve leaflets to the inner walls of the heart. In one embodiment in particular, a method of treating heart disease includes obtaining access to a heart valve chord and cutting it mechanically or with energy such as a laser, or by heating the chordae to elongate them, thereby allowing the previously restricted leaflet to be less restricted so that it can coapt with the opposing leaflet.
• In another embodiment directed to the chordae that connect heart valve leaflets to the inner walls of the heart, a cam-shaped ring is disclosed. The cam-shaped ring is sized to fit within a left ventricle of a heart. The ring forms a hole that is sized to receive two or more chordae tendineae. The ring is formed by connecting two detachable ends of the ring.
• Methods of treatment using the cam-shaped ring are also disclosed. One method in particular includes introducing the ring into a left ventricle of a heart. One or more chordae tendineae are then surrounded by the ring, and the two ends of the ring are then attached to form a closed ring around the chordae tendineae. The ring is then rotated such that one or more of the chordae tendineae are shifted away from their initial orientation by the rotation of the cam-shaped ring. The ring may then be fixed in the rotated or tightened position.
• An embodiment directed at the chordae of heart valve leaflets is now described.FIG. 13A shows a device that can be used to alter a chordae. A method includes obtaining access to a chordae tendinea (chord) within an individual's heart chamber. The chordae is then cut at a point along its length so that a length of the chordae tendinea is freed from the heart chamber leaving behind a length of chordae tendinea having a free end and an end attached to an edge of a heart valve.
• With reference toFIG. 13A, asynthetic chord1005 of greater length than the free length of chordae is introduced into the heart chamber. One end of thesynthetic chordae1005 is connected to awall1305 of the heart chamber or to a muscle attached to the wall of the heart chamber. Another end of the synthetic chord is attached to the free end of the chorda tendinea or to the leaflet.
• In this regard, the end of thechord1005 that is attached thewall1305 can have any of a variety of devices that facilitate such attachment.FIGS. 13B and 13C show enlarged views of attachment devices contained withinbox13 ofFIG. 13A. The attachment devices can be used to attach thechord1005 to thewall1305. InFIG. 13B, theattachment device1310 is an enlarged ball having a distal trocar for penetrating thewall1305. InFIG. 13C, theattachment device1310 is a hook that is configured to penetrate through thewall1305. It should be appreciated that theattachment device1310 can have other structures and it not limited to the structures shown inFIGS. 13B and 13C. In variations of these embodiments, it may be advantageous to adjust the length of the chordae (synthetic, or modified), determine the therapeutic effect of the shortening or lengthening, and then fix the chordae at the most efficacious location.
• Valve regurgitation due to flail or broken chordae can occur. Such valve impairments can be treated percutaneously through chordal replacement or the supplementing of the chordae tendineae of the mitral valve. Although the embodiments described herein are with reference to treating mitral valve impairments it should be appreciated that other valves could similarly be treated with the embodiments described herein. The configuration of the chordal replacement devices described herein can vary. Features of the various devices and their anchoring systems can be used in combination with any of the embodiments described herein.
• The chordal replacement devices described herein can be delivered using interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The chordal replacement devices described herein can be compressed to a low profile for minimally-invasive or percutaneous delivery. They can be advanced from the remote access site through the vasculature until they reach the heart. For example, the chordal replacement devices can be advanced from a venous site such as the femoral vein, jugular vein, or another portion of the patient's vasculature. It is also appreciated that chordal replacement devices can be inserted directly into the body through a chest incision. A guidewire can be steered from a remote site through the patient's vasculature into the inferior vena cava (IVC) through the right atrium so that the guidewire pierces the interatrial septum. The guidewire can then extend across the left atrium and then downward through the mitral valve MV to the left ventricle. After the guidewire is appropriately positioned, a catheter can be passed over the guidewire and used for delivery of a chordal replacement device.
• Embodiments of the chordal replacement devices described herein can also be delivered using a catheter advanced through retrograde access through, for example an artery, across the aortic arch and the aortic valve and to the mitral valve by way of the ventricle. Alternative delivery methods of chordal replacement device embodiments described herein can include inserting the device through a small access port such as a mini-thoracotomy in the chest wall and into the left ventricle apex. From there, the chordal replacement device can be advanced through the left ventricle into the left atrium. It should be appreciated the device can also be delivered via the left atrial apex as well. Positioning of the tool and/or chordal replacement devices described herein can be confirmed using a variety of imaging means such as magnetic resonant imaging (MRI), intracardiac echocardiography (ICE), transesophageal echo (TEE), fluoroscopy, endoscopy, intravascular ultrasound (IVUS) and the like.
• In an embodiment and as shown inFIGS. 38A-38C, achordal replacement device3805 can include a laterally-stabilized spring or flexible rod. In one embodiment, thedevice3805 can include afirst portion3810 that receives and/or is movable with respect to asecond portion3815. The first andsecond portions3810,3815 can be surrounded by aspring3820. Each of the first andsecond portions3810,3815 of thedevice3805 can have aplatform region3825,3830, respectively between which thespring3820 extends. Theplatform regions3825,3830 can be of sufficient surface area or diameter that they can push against the heart wall and the leaflet surface without damaging or puncturing the surfaces. In an embodiment, theplatform regions3825,3830 can also each have one ormore barbs3835 or another fixation device on an external surface that can implant and attach thedevice3805 between the valve leaflet and the roof of the atrium (seeFIG. 38C). It should also be appreciated that other attachment mechanisms for attaching one or more of the platform sections to the valve leaflet and/or the roof of the atrium are possible and that the device is not limited to including barbs. For example, one or more of the platforms can include clips such as a clip similar to the Mitraclip® to grasp the leaflet, and an adhesive or screw to attach to the roof of the atrium.
• Thechordal replacement device3805 can be delivered into the left atrium through a guide catheter3840 (seeFIG. 38B). Atether3845 can hold thedevice3805 normal to the tip of theguide catheter3840. Thetether3845 can be threaded through theguide catheter3840, through theimplant3805, and back out theguide catheter3840. When the procedure is completed, thetether3845 can be pulled out of theguide catheter3840 from either end releasing the implant, allowing deployment. Other mechanisms of attachment to theimplant3805 are considered herein. For example, thetether3845 can be replaced by a flexible rod having, for example threads at a distal end. The threads of the rod can attach to corresponding threads on theimplant3805. The threaded region of the implant can be rotatable such that theimplant3805 can rotate perpendicular to the guide catheter3840 (see the position shown inFIG. 38B) in order to couple and uncouple with the rod through rotational threading and unthreading.
• As shown inFIG. 38B, asecond tether3850 can be used to longitudinally compress thespring3820 between theplatforms3825,3830 such that they approximate one another and thefirst portion3810 receives a greater length of thesecond portion3815 than it receives in the uncompressed state and the overall length of thedevice3805 is reduced as defined by the distance between the barbs. Thissecond tether3850 can thread through theguide catheter3840 in a similar manner as thefirst tether3845 as described above. Thesecond tether3850 can be tensioned to compress thespring3820 and after removal can be withdrawn similarly as thefirst tether3845. In an embodiment, abarb3835 can be planted into a portion of the flailing valve leaflet and anotherbarb3835 can be planted into the roof of the left atrium LA. The barbs can be planted by actuating the distal curved section of the guide catheter so as to guide thebarbs3835 into the desired locations.
• Thedevice3805 can exert a force between the atrium roof and the valve leaflet through thespring3820 to hold the leaflet down and prevent flail up into the left atrium LA. The tension can be adjusted by varying the spring coupled to the device prior to inserting it into the body. Alternatively, the desired length of the device after implantation can be adjusted and tuned prior to introduction with an adjustable bolt and nut type design that limits how far one platform can move in relation to the other. It should be appreciated that the embodiments of chordal replacement devices described herein are exemplary and that variations are possible.
• In another embodiment shown inFIGS. 39A-390, achordal replacement device3905 can include aclip3910, adistal anchor3915 and atether3920 extending therebetween. Theclip3910 can attach to a portion of a flailing leaflet LF and thedistal anchor3915 can extend into the ventricle such that the flailing leaflet is held down. For example, theanchor3915 can be implanted in the left ventricular wall or septum or papillary head or other appropriate tissue site. The length of thetether3920 can be variable and/or adjusted such that the tension applied to the leaflet LF by thechordal replacement device3905 is tailored to an individual patient's needs. For example, once theclip3910 is positioned, thetether3920 can be tensioned, tied and trimmed as will be described in more detail below.
• Theclip3910 can be an elastic element that can be deformed to attach it to a portion of the leaflet LF, such as by crimping. In an embodiment, theclip3910 can be attached to a portion of the valve leaflet LF where flail occurs, for example it can be fastened to an edge of the anterior or posterior mitral valve leaflet with the damaged chord. Theclip3910 can havesurface feature3950, such as small barbs or a textured surface, that aids in the capture of the leaflet LF upon deforming theclip3910 to the leaflet LF. As best shown inFIG. 39A, theclip3910 can also include an eyelet, aperture orother attachment feature3945 that provides a location for coupling to or extending thetether3920 through a portion of theclip3910. Thedistal anchor3915 can similarly include an eyelet, aperture orattachment feature3945 that provides a location for thetether3920 to couple to or extend through a portion of the anchor3915 (seeFIG. 39A, for example).
• Theanchor3915 can vary in configuration and can include a weight, barb, corkscrew, adhesive or other mechanism such that thetether3920 extends down and is secured in place within the ventricle. In an embodiment, theanchor3915 extends into the ventricle from theclip3910 and is secured to the bottom of the ventricle or toward the ventricular septum or papillary head. In an embodiment, the barbs of theanchor3915 can be collapsible such that they conform to a narrow configuration and fit within the lumen of the guide catheter and expand upon being advanced out of the guide catheter (seeFIGS. 39B-39C).
• As mentioned above, thetether3920 can attach to theclip3910 in a variety of ways. Theclip3910 can include anattachment feature3945 that provides a location for coupling theclip3910 to thetether3920. For example and as shown inFIG. 39D-39H, a knot or crimp3930 can be applied to one end of thetether3920 such that end will lodge into a portion of theclip3910 or will lodge into theattachment feature3945. The opposite, unknotted end of thetether3920 can extend through thedelivery catheter3960 and be retracted until thecrimp3930 lodges with theattachment feature3945 on theclip3910, which is attached to the leaflet LF. Thedelivery catheter3960 can be used to deploy theclip3910 to the leaflet (FIG. 39E) and can then be withdrawn (FIG. 39F). At this stage thetether3920 can still have both ends extending outside the body (FIG. 39G). Ananchor3915 also coupled to thetether3920 can be loaded over thetether3920 and delivered to the ventricle as will be described in more detail below.
• In another embodiment shown inFIG. 39J-39M, thedelivery system3955 for thechordal replacement device3905 can include aguide catheter3966 having alumen3965 for aclip delivery catheter3970 and alumen3975 for an anchor pusher ormandrel3980 used to push theanchor3915 out of thedelivery system3955. Theanchor3915 is shown as a barbed anchor, but it should be appreciated that other configurations are considered herein. Theanchor3915 can be attached to a distal end of themandrel3980 such as by correspondingthreads3990 or another coupling mechanism. Upon being pushed out the distal end of theguide catheter3966, theanchor3915 can be uncoupled from the mandrel3980 (such as by an unthreading rotation) and released in its position within the heart. Alternatively, theanchor3915 can be unattached to themandrel3980 and simply pushed out the distal end of theguide catheter3966. Once theanchor3915 is implanted, themandrel3980 can be withdrawn.
• It should be appreciated that theclip3910 can be deployed prior to, during or after delivery of theanchor3915. The embodiments ofFIGS. 39D-39H andFIG. 39K illustrate the deployment of theclip3910 prior to theanchor3915 being delivered.FIGS. 39L-39M illustrate an embodiment in which theclip3910 is deployed after theanchor3915 is delivered.
• As mentioned above, once theclip3910 is positioned on the leaflet LF and theanchor3915 deployed and secured within the ventricle, thetether3920 can be tensioned. For example, thetether3920 can be pulled manually to tension an end of thetether3920 extending outside the body, to the desired tension to hold the leaflet LF down. Tension on thetether3920 can be tuned and adjusted until an appropriate tension on the leaflet LF is achieved evidenced by thetether3920 simulating the tension of a healthy chord. The appropriate tension can be assessed as is known in the art. For example, an echocardiogram can be performed to assess leaflet flail or prolapse as well as the effect on mitral regurgitation. Once the appropriate tension is achieved, thetether3920 can be clamped and cut to remove the excess length of thetether3920.FIGS. 39N-390 illustrate an embodiment of a dual-function cutting clamp3935 having thetether3920 extending therethrough. The cuttingclamp3935 can have dual functions and can be used to clamp onto thetether3920 to secure it near the distal end and it can also be used to cut thetether3920 proximal of the secured section. As best shown inFIG. 39O, the cuttingclamp3935 can have anouter shell3937 that can be coupled or attached to theanchor3915. Theshell3937 of the cuttingclamp3935 can have apertures orslots3939 at opposite ends through which thetether3920 can extend into an inner region of theshell3937. From one end of theshell3937, thetether3920 extends towards theclip3910. At the opposite end of theshell3937, thetether3920 extends back through thedelivery catheter3970 to the outside of the body. The cuttingclamp3935 can also include an aperture orslot3941 through which anactuator line3943 can pass and extend to the outside of the body. Theactuator line3943 can be actuated to effect clamping and/or cutting of thetether3920 with the cuttingclamp3935.
• Still will respect toFIG. 39O, the cuttingclamp3935, which may or may not already be coupled to theanchor3915 can be actuated such that thetether3920 is engaged by a ratcheting clamp mechanism. The ratcheting clamp mechanism prevents the release of the tension on thetether3920. The ratcheting clamp mechanism can include opposingclamp elements3946 that extend inward from aratchet recess3947 open at an inner surface of theshell3937. The opposingclamp elements3946 have textured surfaces at one end that are designed to come together to releasably engage thetether3920. At an opposite end the opposingclamp elements3946 can have aratchet mechanism3949 that engages corresponding features in theratchet recess3947 of theshell3937. The opposingclamp elements3946 can be actuated by pulling theactuator line3943 at the outside of the body. Theactuator line3943 engages the opposingclamp elements3946 such that they extend out from theratchet recess3947 and approach one another until thetether3920 is caught between their textured surfaces. After the opposingclamp elements3946 are engaged with one another and the tension on thetether3920 is maintained, theactuation line3943 can be actuated further until the opposingcutting elements3951 are engaged by theactuation line3943, extend from theirrespective ratchet recess3947 until their cutting surfaces come in contact to cut thetether3920 therebetween. Once thetether3920 is cut by the opposingcutting elements3951 theactuation line3943 can be released and the loose end of thetether3920 can be removed from outside the body. In an embodiment, multiplechordal replacement devices3905 can be used to attach to the chordae on the opposite or same side as the flailing leaflet. The secondchordal replacement device3905 can incorporate a similar cutting clamp as described above.
• In another embodiment as shown inFIG. 40A-40B, achordal replacement device4005 can include a flexible material orpatch4010 that can be attached to the valve leaflet LF. A single strand ofartificial chordae4015 can loop through and underneath thepatch4010. The strand ofartificial chordae4015 can include one, two, three or more individual loops and can be made of suture or another flexible material. The loops ofartificial chordae4015 can be drawn together at one end with aring4020 or other enclosed shape going through the loops ofartificial chordae4015. Thering4020 can be attached to the ventricle wall or papillary muscle or ventricular septum with a distal attachment assembly as described in more detail below.
• The loops ofartificial chordae4015 can be a single strand of material that freely slides through thepatch4010 and thering4020 such that theloops4015 can self-equalize to evenly distribute the load. Asingle loop4015 can thread through thepatch4010 and thering4020, for example three times, such that one loop is short and there are two other loops that are long. Pulling thering4020 away from thepatch4010 will engage the short loop and redistribute the long loops to the length of the shortest loop such that the three loops are equally long and equally distribute the force. The loops ofartificial chordae4015 are not fixed such that they can slip and distribute the force equally between them. This self-equalizing characteristic along with theflexible patch4010 reduces the stress on the leaflet LF.
• As shown inFIGS. 41A-41B, thedevice4005 can be delivered to the valve leaflet (posterior or anterior). Thepatch4010 can be folded and loaded into adelivery catheter4025 such that theartificial chordae4015 trail behind and are delivered through aguide catheter4030 to the vicinity of the valve. A mandrel orpusher tube4035 can push thepatch4010 out the distal end of the delivery catheter4025 (seeFIG. 41C).
• The leaflet LF can be stabilized using a vacuum or a hook attached to a guidewire or another stabilizing device. In an embodiment shown inFIGS. 41G-41N, the leaflet LF can be captured and/or stabilized using aguidewire4141 having a distal end that has a needle point. Theneedle point guidewire4141 can be delivered using a protective sheath ordelivery catheter4143 that prevents pricking of the vessel as it is passed therethrough. The sheath ordelivery catheter4143 can be retracted slightly exposing the distal needle point to the leaflet LF. The distal needle point can be urged through the leaflet LF near an edge or positioned closer to the valve annulus. Theneedle point guidewire4141 can be pre-formed to have a hook shape such that when it is advanced out of thesheath4143 and extends through the leaflet LF it can curve upward back toward thesheath4143 to form a hook. In another embodiment shown inFIGS. 41O-41P, theguidewire4141 can include athicker needle point4145 attached to a moreflexible cable4147 or guidewire or thinner wire. Theneedle point4145 can also be preformed such that it takes on a sharper curve or hook shape when advanced beyond the distal end of thedelivery catheter4143. Theneedle point4145 can be formed of a variety of materials such as Nitinol or other shape memory alloy or other suitable material.
• Tension can be applied to theneedle point guidewire4141 such that the leaflet LF remains hooked and stabilized. Alternatively, the chordae can provide the resistance allowing theneedle point guidewire4141 to puncture the leaflet LF. Theneedle point guidewire4141 as it forms the hook shape can penetrate the leaflet LF a second time (seeFIG. 41K) although it should be appreciated that the guidewire need only penetrate the leaflet LF a single time to effect capture and stabilization (seeFIG. 41M). To release the leaflet LF from theneedle point guidewire4141, thesheath4143 can be advanced distally back over the needle point as shown inFIG. 41N. The portion of theguidewire4141 penetrating the leaflet LF is slowly withdrawn as thesheath4143 is advanced distally.
• Thepatch4010 can be affixed to the valve leaflet LF by activating aleaflet attachment device4040 through theguide catheter4030. In an embodiment, theleaflet attachment device4040 can include a pair ofexpandable elements4045 connected centrally by arod4050. One or more of theexpandable elements4045 can have asharp needle point4055. Thepatch4010 can lie on top of the valve leaflet LF and thesharp needle point4055 of the leadingexpandable element4045 can pierce through thepatch4010 and the leaflet LF such that the leadingexpandable element4045 emerges from the underneath side of the leaflet LF and therod4050 extends through the leaflet (seeFIGS. 41D and 41E). Thepatch4010 on the upper surface of the leaflet LF can be sandwiched between the leading and trailingexpandable elements4045 of theleaflet attachment device4040. Theleaflet attachment device4040 and each of theexpandable elements4045 can be a shape-memory metal (e.g. Nitinol, Nitinol alloys) or some other spring material. The spring material of theexpandable elements4045 allows them to spring out as theleaflet attachment device4040 is advanced from the distal end of thedelivery catheter4025. The leaflet attachment can be facilitated by stabilizing the leaflet as described above. The position of the patch prior to securement of theexpandable element4045 can be maintained for example, by attaching the patch to the first expandable element prior to being deployed from the delivery catheter. The delivery catheter can then be used to maneuver into position the patch prior to deploying the first expandable element.
• FIG. 41F shows a top view of anexpandable element4045 deployed on the upper surface of the leaflet. The embodiment is shown having barbed arms in a star-shaped configuration although it should be appreciated that other shapes and configurations are considered. For example, as shown inFIGS. 42A-42B, theleaflet attachment device4040 can includeexpandable elements4045 of a spring metal mesh. The spring metal meshexpandable element4045 can form a web shape and flatten out as it is deployed. Alternatively, the Nitinol or other spring material can spring into anexpandable element4045 shaped like a mesh ball (seeFIG. 42C). Upon expansion, the mesh ballexpandable element4045 can protectively cover thesharp needle point4055 on the underneath side of the valve leaflet. It should also be appreciated that theleaflet attachment device4040 can includeexpandable elements4045 that are a combination of configurations including flat mesh design, ball mesh design, a star-shaped design or other configuration. For example, oneexpandable element4045 can have a star-shaped design and the otherexpandable element4045 can have a mesh ball design (seeFIG. 42D). The expandable devices such as the mesh ball design can be collapsed sufficiently small to pass through a needle hole without ripping the leaflet. In an embodiment, the needle bore can be a larger hypotube such that insertion of the tube needle can punch a hole in the leaflet. Thepatch4010 can cover the hole such that leaks are avoided. Further, the hypotube can be dull at the base of the bore such that punched out tissue remains attached to avoid creation of an embolism.
• It should be appreciated that more than oneleaflet attachment device4040 can be used to affix apatch4010 to the valve leaflet LF. As shown inFIG. 43A, thepatch4010 can be attached to the atrial side of the valve leaflet LF with multipleleaflet attachment devices4040 oriented side-by-side on the upper and lower surface of the leaflet LF. Using multipleleaflet attachment devices4040 to affix thepatch4010 reduces stress in the leaflet LF, in part, due to distribution of forces across multiple attachment locations. As shown inFIG. 43B, the multipleleaflet attachment devices4040 can be stacked and deployed in series from adelivery catheter4025. In another embodiment, the multipleleaflet attachment devices4040 can be deployed using a guide wire between deployments of eachleaflet attachment device4040. For example, thepatch4010 can be deployed followed by the firstleaflet attachment device4040. Thedelivery catheter4025 can be withdrawn leaving aguide wire4060 in place. Another catheter with the secondleaflet attachment device4040 can then be advanced along theguide wire4060 and the secondleaflet attachment device4040 deployed. The process can be repeated depending on the number of attachment devices desired to be deployed.
• Once thepatch4010 is positioned and affixed to the leaflet LF, such as with the leaflet attachment device(s)4040, the loops ofartificial chordae4015 can be deployed distally within the ventricle such as to the ventricular wall, septum or papillary muscle. As shown inFIG. 44A, thedelivery catheter4025 that deployed thepatch4010 and leaflet attachment device(s)4040 can be removed from theguide catheter4030 leaving aguide wire4060 attached to aring4020 through which theartificial chordae4015 loop (attachment device(s) are not shown in the figure for simplicity). Theguide wire4060 can be previously looped through thering4020, for example, during manufacturing. Another catheter can be advanced over theguide wire4060 through theguide catheter4030. In an embodiment, thering4020 is attached to the distal end of thecatheter4030 as shown inFIG. 44B-44C. For example, thering4020 can be inserted or snapped into aflanged channel4065 near the distal end of thecatheter4030 using theguide wire4060 looped through thering4020. Thecatheter4030 with thering4020 in thechannel4065 can advance through the valve distally into the ventricle (seeFIG. 44D).
• As shown inFIGS. 45A-45D, thering4020 with the attached loops ofartificial chordae4015 can be anchored to the ventricular wall or papillary muscle forming adistal attachment assembly4070 of the chordal replacement device. In an embodiment acoil screw4075 is coupled to thedistal attachment assembly4070. Thecoil screw4075 can be advanced like a cork screw through the distal end of thecatheter4030 into the ventricular tissue, for example, by rotating an actuator knob on the proximal end of the catheter. The rotation of the actuator knob can rotate the coil screw, advancing it out of the catheter and into the ventricular tissue.
• In another embodiment, thedistal attachment assembly4070 can be coupled to or can include afillable element4080 delivered through ahollow needle4085 that pierces the ventricular wall (SeeFIGS. 45B-45C). Thefillable element4080 can include a balloon or mesh bag or other expandable element. A hardening agent or other material can be used to fill theelement4080 expanding it such that it anchors theartificial chordae4015 and thedistal attachment assembly4070 to the ventricle. Theneedle4085 can be retracted leaving the filledelement4080 inserted in the ventricle wall and coupled to thedistal attachment assembly4070. The hardening agent can be a two-part hardening agent, such that a small quantity of a second agent can be delivered through another smaller tube in the catheter to activate the first part and main bulk of the hardening agent.
• After the distal anchor (e.g. coil screw4075 or filled element4080) of thedistal attachment assembly4070 is attached to the ventricular wall or papillary muscle, thedistal attachment assembly4070 can be released from theguide catheter4030. Theassembly4070 can be released, for example, using a mandrel that runs through the catheter and has a threaded end that threads into the distal attachment assembly. In another embodiment, the distal end of the catheter can be a sleeve that pinches circumferentially onto the attachment assembly and then by retracting a lever proximally, a mandrel is retracted which pulls the pinching sleeve backwards over the catheter slightly, expanding the pinching sleeve and releasing the attachment assembly. The two ends of theguide wire4060 can extend all the way up through theguide catheter4030. As thedelivery catheter4025 is removed, theguide wire4060 can still be looped through thering4020. Theguide wire4060 can be removed before, during or after thedelivery catheter4025 is removed. Theguide wire4060 can be removed by pulling one end, allowing the trailing end to pull through thering4020 and then out of theguide catheter4030 leaving thedistal attachment assembly4070 anchored in the ventricle and theartificial chordae4015 extending up to the valve leaflet LF where thepatch4010 is affixed to the leaflet LF with the leaflet attachment device(s)4040.
• Once the chordal replacement device is deployed, the tension of theartificial chordae4015 can be adjusted. In an embodiment, asensor4090 such as a pin or pressure sensor can be used to adjust tension in theartificial chordae4015. Thesensor4090 can provide the user with information regarding contact between theguide catheter4030 and the ventricular wall. As shown inFIG. 46A-46B, thesensor4090 can include apin4095 near the distal tip of thecatheter4030. Thepin4095 is shown inFIG. 46A as fully extended indicating no contact with the ventricular wall. Upon contact with the wall as shown inFIG. 46B, thepin4095 can compress and activate delivery of a signal to the user such as an electrical signal or visual signal indicating that contact is made with the wall of the ventricle. If thesensor4090 indicates contact with the ventricular wall and an echocardiogram suggests no flail or prolapse and mitral regurgitation (MR) is reduced then the distal anchor (e.g. coil screw4075 or element4080) can be advanced into the ventricular wall to secure attachment. If thesensor4090 indicates contact with the ventricular wall, but the echocardiogram suggests flail and/or prolapse and poor MR results, thecatheter4030 can be moved further down into the ventricle to increase tension on theartificial chordae4015 and the test repeated. If thesensor4090 indicates contact with the ventricular wall, and the echocardiogram suggests no flail and/or prolapse but the MR results are still poor, the leaflet is pulled down too far and thecatheter4030 can be moved proximally to release tension on theartificial chordae4015. The test can be repeated until desirable results are achieved.
• Once the distal anchor is advanced into the ventricular wall and adequate results are obtained, fine-tuning of the tension can be performed (seeFIG. 47). In an embodiment, the distal anchor can be acoil screw4075 that is advanced and locked. Thedistal attachment assembly4070 can be rotated clockwise by thecatheter4030 to draw thering4020 slightly closer to the ventricular wall. Thedistal attachment assembly4070 can also be rotated by thecatheter4030 in a counter-clockwise direction to push thering4020 away such that the valve leaflet LF can rise up slightly.
• In another embodiment as shown inFIGS. 48A-48B, the distal anchor can be an expandable element, such as a balloon anchor filled with a two-part epoxy as described above. This embodiment can also be fine-tuned. As theexpandable element4080 expands within the ventricular wall, thedistal attachment assembly4070 attached to theexpandable element4080 is pulled toward the ventricular wall. The material of theexpandable element4080 can be finitely expanded such that fine-tuning of the distance between thedistal attachment assembly4070 and the ventricular wall can be performed. As theexpandable element4080 is unexpanded theartificial chordae4015 can pull thedistal attachment assembly4070 away from ventricular wall and the valve leaflet can rise slightly. Once gross adjustments are performed, fine-tuning the tension on theartificial chordae4015 attached to the valve leaflet can be performed. The first part epoxy (i.e. prior to hardening) can be used to fill theexpandable element4080 and also fine-tune the positioning and tension on thechordae4015. Once the proper position is confirmed, the second part of the epoxy can be infused such that it hardens and sets in place the chordae. It should be appreciated that the epoxy can be embedded directly into the attachment site or can be used to fill a expandable element pre-embedded in the distal attachment site. Ideally, very little of the second part epoxy is used so as not to interfere with the fine-tuning achieved.
• The chordal replacement device need not include a distal attachment assembly4070 (seeFIGS. 49A-49B). For example, the chordal replacement device can be attached to an attachment assembly that is deployed proximal to the valve. In an embodiment, the chordal replacement device can include aring4020 and loops ofartificial chordae4015 attached to arod4105 extending from a spring material (e.g. shape-memory metal such as Nitinol or other material) that forms a stent-like mesh4100 deployed in the left atrium, just above the mitral valve. Therod4105 can be attached to themesh4100 and extend from themesh4100 through the mitral valve such as at one of the commissures into the ventricle. Therod4105 can be straight or curved or jointed. The distal end of therod4105 can be attached to thering4020 such as by extending through thering4020.Rod4105 andmesh4100 can be moved to adjust tension on theartificial chordae4015. Once in a desirable location and the desired tension is achieved, themesh4100 androd4105 can be secured within the atrium or to the valve leaflets, for example using theleaflet attachment devices4040 discussed above (seeFIG. 49B; note the rod, ring and replacement chordae are not shown).
• As shown inFIG. 50A, therod4105 andmesh4100 can be delivered through adelivery catheter4025 in which themesh4100 is collapsed. As mentioned above, therod4105 can be jointed. Thejoints4110 can lock in place once therod4105 is deployed and/or can have limited travel around the joint4110. As shown inFIGS. 50C-50E, one or more of therod joints4110 can lock into place using a mechanical/physical feature incorporated within the joint4110. In an embodiment, one or more of thejoints4110 can have asurface feature4112 such that when therod4105 rotates over thesurface feature4112 on the adjacent portion of the joint4110 it can pop over and lock in place relative to the adjacent portion of the joint4110.
• Even in the locked position, one or more of thejoints4110 can have limited travel around the joint4110 to provide theartificial chordae4015 with some degree of slack (seeFIG. 50B). Therod4105 andmesh4100 can passively rise and fall with the mitral annulus during the cardiac cycle. In diastole, when the annulus rises, excessive tension on theartificial chordae4015 can be avoided due to this limited travel around the joint4110. In an embodiment, the top joint4110 can lock and the bottom joint does not lock. In this embodiment, the lower joint can pivot without detriment to the system as the annulus rises during diastole. During systole, the lower joint can pivot in the opposite direction due to tension on the chordae until the physical stop incorporated in the joint limits the travel. In this position the rod system can then provide tension to the chordae and hold the leaflets down. As shown inFIG. 50F, the top joint4110 rather than being fixed can pivot about an axis that is orthogonal to the axis of the bottom joint. This arrangement can prevent the forces of the cardiac cycle from bending the top joint once deployed.
• With reference toFIGS. 51A-51B, rather than using a jointed rod, therod4105 can be flexible so that it can fit in adelivery catheter4025 and expand to its spring-formed shape when deployed from thedelivery catheter4025. Flexibility ofrod4105 can be designed so that it provides a predictable spring force on theartificial chordae4015. Therod4105 can deflect and provide consistent tension on theartificial chordae4015.
• It should be appreciated that in addition to a chordal replacement system, theleaflet attachment devices4040 described above can be used to attach a leaflet extension patch for the treatment of mitral valve prolapse or flail. As shown inFIGS. 52A-52C, theleaflet extension patch5210 can be attached to the atrial side of the valve leaflet. Theleaflet extension patch5210 can be a stiff or a flexible material. Theleaflet extension patch5210 can prevent mitral regurgitation in the case of prolapse or flail in that it can block the leaflet from flailing upwards into the atrium. For functional mitral regurgitation, theleaflet extension patch5210 can bridge any coaptation gap between the leaflets.
• FIG. 52A shows theleaflet extension patch5210 during diastole. Thepatch5210 can follow the leaflet downwards such that flow through the valve is not impeded. During systole, theleaflet extension patch5210 can block flow by coapting with the opposite leaflet LF as well as prevent flail or prolapse by physically blocking it from moving upwards into the atrium (seeFIGS. 52B and 52C).
• Other embodiments are directed to atrial or ventricular remodeling to alter the shape of an atrium or ventricle. Now with respect toFIG. 14 which shows a cross-sectional view of the heart with a first and second anchor attached to a wall of the heart. The system includes afirst anchor1410ahaving a screw portion1415 for screwing into a wall of the heart and a connector portion. The connector portion is rotatable around an axis of rotation. The first anchor includes a power source to power rotation of the connector portion and a receiver for receiving telemetric signals from an external controller for controlling the rotation of the connector portion. The system includes asecond anchor1410bhaving ascrew portion1415bfor screwing into a wall of the heart and a connector portion. Also included is atether1420 having two free ends. One of the free ends is coupled to the connector portion of the first anchor, and the other free end is coupled to the connector portion of the second anchor. An external controller is also included. The external controller has a telemetric transmitter for communicating with the receiver and controls the rotation of the connector portion. Alternatively, the anchors may be placed with a torqueable catheter.
• In another embodiment, a method of altering a geometry of a heart includes introducing a first coupler into a heart chamber. The first coupler has an anchor portion and a connector portion. The connector portion is rotatable around an axis of rotation and is connected to a power source to power rotation of the connector portion. The power source is in communication with a telemetric signal receiver. The first coupler is secured to the wall of the heart chamber by anchoring the anchor portion to the wall. A second coupler is introduced into the heart chamber. The second coupler includes an anchor portion and a connector portion. The second coupler is secured to the wall of the heart chamber by anchoring the anchor portion to the wall at a distance from the first coupler.
• A tensile member is introduced into the heart chamber. One end of the tensile member is connected to the connector portion of the first coupler, and another end of the tensile member is connected to the connector portion of the second coupler. The distance between the first and second couplers is adjusted by transmitting a telemetric signal to the receiver, thus causing the connector portion to rotate around the axis of rotation and threading the tensile member around the connector portion to reduce the distance between the first and second couplers.
• In another embodiment, a system for altering the geometry of a heart chamber includes a planar tensile member having substantially inelastic material. At least two anchors are included for anchoring the planar tensile member to an inner wall of a heart chamber. The planar tensile member is substantially shorter in length than a left ventricle of a heart so that when the planar tensile member is anchored in a caudal direction along a length of the left ventricle a tensile force exerted by the planar tensile member between the two anchors prevents the left ventricle from dilating caudally.
• In another embodiment, a method for altering the geometry of a heart includes providing a tensile member having a substantially inelastic material. The tensile member is substantially shorter in length than a left ventricle of a heart. The tensile member is inserted into the left ventricle of the heart and a proximal end of the tensile member is anchored to the left ventricle adjacent the mitral valve. A distal end of the tensile member is anchored to the left ventricle caudal the proximal end so that a tensile force exerted by the tensile member between the two anchors prevents the left ventricle from dilating caudally.
• Other embodiments are directed to strengthening or reshaping the left ventricle of the heart. In one embodiment in particular, a method of reinforcing the left ventricle includes injecting a strengthening agent into a wall of the left ventricle in an enlarged region of the ventricle, as shown inFIG. 15.FIG. 15 shows a catheter1510 that has been introduced into the heart. The catheter1510 has an internal lumen through which thestrengthening agent1512 can be injected. A proximal end of the catheter is connected to a source of the strengthening agent and a distal end of the catheter is configured to release the strengthening agent. As shown inFIG. 15, the distal end of the catheter is positioned at or near a wall of the heart and thestrengthening agent1512 is injected into the wall of the heart.
• In another embodiment, a method is directed to altering the geometry of a heart. The method includes injecting a polymerizing agent into a pericardial space adjacent a left ventricle, thereby exerting a medial (inward) force against the left ventricle.
• In yet another embodiment, a method of altering the geometry of a heart includes inserting a balloon into a pericardial space adjacent to a left ventricle of the heart, or extend into the pericardium of the heart. The balloon is inflated by injecting it with a fluid, and it exerts a medial force against the left ventricle upon inflation. In certain embodiments, the balloon can be inflated at the time of implantation, or at a later time. If inflated at a later time, the balloon would be self-sealing, and may be inflated by accessing the balloon with a needle placed through the chest wall.
• Other embodiments are directed to adjusting the length or orientation of papillary muscles.FIG. 16 shows a schematic view of the heart showing the papillary muscles PM. With reference toFIG. 16, a method of treating heart disease includes inserting an anchor, cuff orsleeve1205 into the left ventricle of an individual's heart, and sliding a cuff or sleeve around a papillary muscle PM. The size of the cuff or sleeve is reduced so that the cuff or sleeve squeezes the papillary muscle. As the size of the cuff or sleeve is reduced, the papillary muscle stretches and increased in length.
• In yet another embodiment, a method of treating heart disease includes obtaining access to a papillary muscle in a left ventricle of the heart. The papillary muscle is cut and reattached at a new location on an inner wall of the ventricle closer to the mitral valve.
• Additional embodiments that employ magnets in the heart are now described with reference toFIGS. 17-19, which show cross-sectional views of the heart. With reference toFIG. 17, in one embodiment one ormore magnets1705 are implanted or otherwise attached to awall1710 of the left ventricle LV. One or moreother magnets1715 are implanted or otherwise attached to awall1720 of the right ventricle. Themagnets1705 and1715 are attached to thewalls1710 and1720 such that they assert an attractive magnetic force (as represented by thearrows1725 inFIG. 17) toward each other. Themagnetic force1725 assists in remodeling of the left ventricle during pumping of the heart. That is, themagnets1705 and1715 are urged toward one another (thereby also urging thewalls1710 and1720 toward one another) to re-shape either the annulus AN or the left ventricle LV. The annulus or the left ventricle LV are re-shaped in a manner that reduces or eliminates backflow through the mitral valve MV. It should be appreciated that a similar procedure can be performed on the right ventricle RV and associated valves.
• FIG. 18A shows another embodiment of a procedure wherein magnets are implanted in the heart to geometrically reshape the annulus or the left ventricle. One ormore magnets1705 are implanted or otherwise attached to afirst wall1710aof the left ventricle LV. One ormore magnets1705 are also implanted or otherwise attached to a second, opposedwall1710bof the left ventricle. The magnets on theopposed walls1710a,1710bexert an attractive magnetic force toward one another to draw thewalls1710a,1710btoward one another and re-shape the left ventricle LV or the annulus AN.
• Another embodiment of a procedure uses magnets to anchor tethers within the heart at various locations to optimize the shape of cardiac structures to improve cardiac function. The tethers are placed to either reshape the cardiac structure or to prevent dilatation of the structure over time. The tethers must be securely anchored to the heart structures. A method of anchoring which enables tethering in various positions and directions within the cardiac structures is important for the clinician to optimize cardiac reshaping based on each individual patient anatomy and disease state. A method of anchoring which is atraumatic is also desirable.
• FIG. 18B shows a side view of the heart with sets of magnets A, A1, B, and B1 positioned to various locations of the heart or to anatomical structures adjacent the heart. In one embodiment, at least one magnet A is placed on the interventricular septum within the right ventricle RV. At least one magnet A1 is placed within the left ventricle LV opposite magnet A. The magnetic force between A and A1 maintains the position of the magnets. The magnets may be enclosed in materials that will promote tissue in-growth and healing to the interventricular septum to ensure stability of location and to eliminate the need for long term anti-coagulation. Additionally, the enclosure material which is flexible and can be delivered in a low profile can be significantly larger in size than the magnets to increase the surface area of contact with the heart wall which will increase the tension that can ultimately be placed on the anchor over time.
• A second set of magnets B and B1 are then delivered to another location selected within or adjacent to the heart. The set of magnets A/A1 are attached to the set of magnets B/B1 using at least onetether1805, as shown inFIG. 18B. Thetether1805 can be attached to either or both of the magnets A/A1 at one end and to either of both of the magnets B/B1 at an opposite end. When the set of magnets B/B1 are tethered under tension to the set of magnets A/A1, a change in the shape of the cardiac structure results to improve cardiac function.FIG. 18B shows magnet B positioned in the LV and B1 positioned in a blood vessel BV adjacent to the heart. The magnetic force between B and B1 maintains the location of B and B1. Magnets B and B1 are delivered on or within materials and structures which promote healing and increase the amount of tension that can be placed on the anchor over time. For example, magnet B1 can be delivered on a stent which is of a length, diameter and material which will heal within the BV to provide sufficient resistance to forces placed on it by the tethers.
• The tethers may be pre-attached to the magnets A and B1 or they may be attached after A and B1 have been positioned. The tether length may be shortened and/or adjusted after placement of the anchors. Alternatively the final tether length may be pre-selected based on the patient's cardiac structure geometry and the effect the clinician desires. Placing sets of magnets in this method, enables anchoring of tethers within the heart in various positions and angles which provides increased flexibility and variation for clinicians to select optimal re-shaping of the cardiac structures based on specific patient characteristics.
• Examples which demonstrate the flexibility of this approach include placing anchors at the annulus and at the apex of the heart and tethered to shorten the length of the LV; anchors can be placed in the around the annulus and tethered to change the shape of the annulus. More specifically, one or more sets of magnets can be placed in the RA and LA at the level of the mitral valve annulus (on the anterior side of the annulus) and one or more sets of magnets can be placed in the LA and LV on opposite sides of the annulus on the posterior portion of the annulus. The posterior sets of magnets can then be tethered to the anterior sets of magnets to change the shape of the annulus. Alternatively, the magnet anchors can be placed at the level of the annulus in the LA and in a BV adjacent to the heart at the level of the annulus and these then tethered to the anterior annulus magnet anchor described above.
• The magnets A and A1 can also be a single magnet that extends through the interventricular septum. Moreover, only one of the magnets A or A1 need be implanted. One or more magnets B and/or B2 are located opposite the location of the magnet(s) A and/or A1. The magnet(s) B is located within the left ventricle opposite the magnets A/A1, such as on the left ventricular wall. The magnet B1 is located on an anatomical structure adjacent the heart, such as on a blood vessel BV.
• In another embodiment shown inFIG. 18C, the magnets A, A1, B, and B1, or combinations thereof, are implanted in the heart without tethers. The magnets A, A1, B, and B1 can be positioned in various combinations so as to exert magnetic attractions to one another to re-shape the left ventricle or the mitral valve annulus. For example, the magnets A and B can be implanted such that they exert an attractive magnetic force relative to one another. The magnets A and B2 can alternately be implanted. Other possible combinations are the magnets A1 and B or the magnets A1 and B2. The magnets can be implanted without tethers such that an attractive magnetic force F causes the magnets and the attached region of the heart to move toward one another to re-shape the heart. Alternately, the magnets can be attached to one another with tethers.
• In yet another embodiment, one ormore magnets1705 are implanted in thewalls1710 of the left ventricle LV and/or the right ventricle RV, as shown inFIG. 19. Themagnets1705 are positioned in opposed locations on thewalls1710 and one ormore tethers1905 attach opposed pairs ofmagnets1705 to one another. One or more of thetethers1905 extend through the interventricular septum to connect a first magnet disposed in the left ventricle and a second magnet disposed in the right ventricle. In certain embodiments, magnet elements do not include tethers, but rely on the magnetic attraction to each other to remodel the tissue between them. For example, a magnetic element may be placed on either side of the interventricular septum, or one element within the septum. Another magnetic element may be placed on or within the opposite left ventricular wall, or in an adjacent vessel on the left ventricular wall. The electromagnetic field of such elements can then interact to cause a remodeling of the left ventricle to assist with ventricular function.
• Thetethers1905 can be elastic so to exert an attractive force between the attachedmagnets1705 and re-shape the left ventricle LV or annulus AN. Alternately, or in combination with elastic tethers, thetethers1905 can be shortened in length after placement to thereby pull the walls of the left ventricle LV toward one another and re-shape the left ventricle LV or the annulus AN. In combination with the force provided by thetethers1905, themagnets1705 exert an attractive magnetic force toward one another to assist in pulling the heart walls toward each other.
• It should be appreciated that one or more magnets can be positioned in other locations of the heart or adjacent anatomical structures for re-shaping of the heart. For example, one or more magnets can be positioned around the annulus AN or can be positioned in the coronary sinus in such a manner that the magnets exert attractive forces toward one another to cause re-shaping of a desired portion of the heart.
• In another embodiment, cardiac re-shaping is achieved through percutaneous placement of one or more tethers that are cinched or anchored in the walls of the left ventricle LV. The tethers provide tension between the walls of the left ventricle to reshape the left ventricle LV in a desired manner.FIG. 20 shows a cross-sectional view of the left ventricle LV with atether2010 positioned therein. Thetether2010 has a first end anchored to a first wall of the left ventricle LV and a second end anchored to an opposed wall of the left ventricle LV. Thetether2010 is tensioned to pull the walls toward one another (as represented by thephantom lines2012 inFIG. 20) and re-shape the left ventricle LV. It should be appreciated that thephantom lines2012 inFIG. 20 are merely representative of the geometric re-shaping. The left ventricle LV can be re-shaped in various manners and the amount of re-shaping can vary depending on the tension applied to thetether2010 and the location of attachment to the walls of the left ventricle LV. The tether may be inelastic or somewhat elastic.
• Thetether2010 can be anchored or otherwise attached to the walls in various manners. In an exemplary embodiment, a patch2015 (shown inFIG. 20) of material is positioned on an exterior surface of the ventricular wall and is attached to one end of thetether2010. A similar patch can also be positioned on the opposed wall and attached to the opposite end of the tether.
• With reference toFIG. 21, the patch is delivered to a desired location using acatheter2105 having a sharpeneddistal end2110 that is positioned within the left ventricle LV. Thecatheter2105 can be delivered to the left ventricle LV in various manners, including trans-aortically (via the aorta), trans-septally (by piercing the interventricular septum), and trans-atrially (via the left atrium LA) pursuant to well-known methods. As shown inFIG. 22, the sharpeneddistal end2110 pierces the ventricular wall such that thedistal end2110 is positioned exterior to the ventricular wall. Thecatheter2105 has an internal delivery lumen having an opening at thedistal end2110. Thepatch2015 is configured to be transported in a contracted state through the delivery lumen and delivered out of the opening at thedistal end2110, where thepatch2015 expands into an expanded state at the exterior of the ventricular wall to seal against the exterior of the left ventricular wall.
• When positioned at the exterior of the ventricular wall, thepatch2015 is configured to act as a reservoir that receives a fluid material that can be delivered to the patch via the delivery lumen of thecatheter2105. The fluid material has a first viscous state of sufficient fluidity such that the material can flow through the delivery lumen of thecatheter2105 and out of thedistal end2110 to the location of thepatch2015. The fluid material changes to a second viscous state when positioned exterior to the ventricular wall at thepatch2015. The second viscous state is of greater viscosity (i.e., more resistant to flow) than the first viscous state such that the fluid material provides support and a level of rigidity to thepatch2015 and to the left ventricular wall. The fluid material can change to the second viscous state after a predetermined time period, after contact with the patch, or when the patch is completely filled. A catalyst can be injected into the fluid material to cause it to change to the second viscous state.
• As shown inFIG. 23, thecatheter2105 can then be disengaged from thepatch2015 such that thepatch2015 is disposed exterior to the ventricular wall. Thepatch2015 can be firmly attached to the ventricular wall (such as using an adhesive) to minimize wear or friction between the patch and the ventricular wall. Next, an end of thetether2010 is attached to thepatch2015. Thecatheter2105 can be used to deliver thetether2010 to thepatch2015 or, alternately, a second catheter can be used. In one embodiment, thetether2010 is already positioned in a delivery lumen of thecatheter2105 while thepatch2015 is being delivered. Thecatheter2105 is then pulled back while the end of thetether2010 remains attached to thepatch2015 to thereby let thetether2010 out from thecatheter2105, as shown inFIG. 23.
• With reference now toFIG. 24, asecond patch2415 is deployed in or exterior to an opposed ventricular wall in a manner similar to that described above. The opposite end of thetether2010 is then attached to thesecond patch2415 such that thetether2010 extends between the two patches, as shown inFIG. 20. Alternately, as shown inFIG. 24, asecond tether2420 is attached at a first end to thesecond patch2415. As shown inFIG. 25, the twotethers2010 and2420 can then be attached together at opposite ends from the patches, such as by using aclip2510, to form a single attachment tether between thepatches2015 and2415. Thetethers2010 and2420 can be twisted or adjusted within theclip2510 to tension the resulting attachment tether between thepatches2415 and2015 and pull the ventricular walls toward one another via the tether. Once properly tensioned, the tether can be clipped or clamped to maintain its position.
• In another embodiment, shown inFIG. 26, aneedle2610 or delivery catheter is passed trans-thoracically into the left ventricle LV to deliver apatch2615 to the exterior of the ventricular wall, as described above. A sealing means, such as a sealing balloon, can be used to seal one or more puncture holes in the wall of the left ventricle caused by theneedle2610 during delivery of thepatch2615. Visualization means, such as fluoroscopy, can be used to visualize proper placement of theneedle2610. A second patch is attached to an opposed wall to form a tether attachment between the walls, as shown inFIG. 20. The tether is then tensioned to pull the walls together and re-shape the left ventricle or annulus of the mitral valve in a desired manner.
• In other embodiments, described with reference toFIGS. 27-31, cardiac re-shaping is achieved by manipulation of the papillary muscles.FIG. 27 shows a schematic, cross-sectional view of the left ventricle LV in a healthy state with the mitral valve closed. The valve chordae CH connect the leaflets LF of the mitral valve to the papillary muscles PM. The papillary muscles PM and the and chordae CH are positioned such that at least a portion of the leaflets LF contact one another when the mitral valve is in the closed state, resulting in functional coaptation of the leaflets.
• FIG. 28 shows the left ventricle LV in a dysfunctional state. The valve chordae CH or the papillary muscles PM are damaged or otherwise dysfunctional such that the leaflets LF do not properly coapt (contact one another). The dysfunction can be manifested by excess tension in the chordae CH such that a gap is located between the leaflets LF, or in some cases one leaflet may function at a different level from the other (e.g. lower (prolapse) or higher (flail)) thereby limiting the ability of the mitral valve to close resulting in mitral regurgitation. The dysfunctional left ventricle LV and in some cases leaflet prolapse or flail, can be treated by manipulating papillary muscles PM to adjust the position of the leaflets LF. In one embodiment, the papillary muscles PM are repositioned toward one another to reduce the distance between the papillary muscles PM.
• In an embodiment described with reference toFIG. 29, a biasing member, such as a rod of adjustable length, or aspring2910, is mounted between the papillary muscles PM with a first end of thespring2910 attached to a first papillary muscle and a second end of thespring2910 attached to a second papillary muscle. Thespring2910 has a pre-load such that thespring2910 provides a biasing force (represented by thearrows2915 inFIG. 29) that pulls the papillary muscles PM toward one another. Such a spring may be covered with polyester fabric or other coating to promote ingrowth into the muscle tissue and minimize the potential for clot formation. The repositioning of the papillary muscles PM re-shapes the left ventricle and/or changes the distance that the leaflets need to move on the chordae CH such that the leaflets LF contact one another to close the mitral valve. The tension provided by thespring2910 can be varied or different springs can be used to achieve a proper repositioning of the papillary muscles PM. The tension may be modified at the time of the procedure or during a subsequent procedure if it is determined that additional coaptation is required.
• In another embodiment, described with reference toFIG. 30, asuture3010 is mounted between the papillary muscles PM with a first end of thesuture3010 attached to a first papillary muscle and a second end of thesuture3010 attached to a second papillary muscle. Thesuture3010 can be attached to the papillary muscles in various manners. For example, anattachment device3015, such as an anchor, cuff or sleeve, can be positioned around or partially around each of the papillary muscles. The ends of thesuture3010 are attached to theattachment devices3015 to secure thesuture3010 to the suture to the papillary muscles.
• Thesuture3010 is tensioned such that it provides a force that pulls the papillary muscles PM toward one another. Thesuture3010 can be tensioned, for example, by twisting thesuture3010 to reduce its the overall length and thereby reduce the distance between the papillary muscles PM, and fixing the suture with a crimping element or other stay element. The amount of twisting or shortening can be varied to vary the tension provided by thesuture3010. In addition, a crimping member may be used to fix the sutures once a desired tension between the muscles is reached. Exemplary crimping members are described in International Patent Publication Number WO 2003/073913, which is incorporated herein by reference in its entirety. As in the previous embodiment, the repositioning of the papillary muscles PM re-shapes the left ventricle and/or changes the tension on the chordae CH such that the leaflets LF contact one another to close the mitral valve. Cuffs or sleeves may be placed around the papillary muscles PM to such as those previously described, to affect the repositioning.
• With reference now toFIG. 31, the papillary muscles PM can also be repositioned by snaring the papillary muscles. Asnare3110 comprised of a looped strand of material is positioned around the chordae CH at or near the location where the chordae attach with the papillary muscles PM. Thesnare3110 is tightened to draw the papillary muscles PM toward one another and re-shape the left ventricle and/or changes the distance that the leaflets need to travel during systole such that the leaflets LF contact one another to close the mitral valve.
• In yet another embodiment, shown inFIG. 36, one ormore clips3610 are clipped to each of the papillary muscles PM. The structure of theclips3610 can vary. Atether3615 attaches theclips3610 to one another. Thetether3615 is cinched to shorten the length of thetether3615 and pull the papillary muscles PM toward one another and re-shape the left ventricle and/or changes the distance that the leaflets need to travel during systole such that the leaflets LF contact one another to close the mitral valve.
• In yet another embodiment, shown inFIG. 37, one ormore clips3610 are clipped to opposed walls of the left ventricle LV. Theclips3610 can be delivered to the left ventricle using adelivery catheter2105. A tether attaches the clips to one another. The tether is cinched to shorten the length of the tether and pull the ventricular walls toward one another and re-shape the left ventricle and/or changes the distance that the leaflets need to travel during systole such that the leaflets LF contact one another to close the mitral valve.
• In all embodiments, once the papillary muscles are fixed or repositioned, it may be advantageous to further treat the area by selectively elongating or shortening the chordae tendinae to achieve further optimal valve function. In addition, a mitral valve clip may be deployed to augment the desired valve function, either before papillary or chordal manipulation, or after, if the desired leaflet coaptation is not achieved with one particular approach.
• As discussed above with reference toFIG. 28, a dysfunctional left ventricle can be manifested by excess tension in the chordae CH such that a gap is positioned between the valve leaflets LF. It can be desirable to eliminate or relieve the excess tension by cutting the chordae CH, and/or cutting the chordae and replacing them with artificial chordae. Prior to cutting the chordae, it can be desirable to evaluate the placement of the artificial chordae to confirm that implantation of the chordae will indeed provide the desired clinical result. This process is now described with reference toFIGS. 32-35.
• FIG. 32 shows aleaflet grasping device1100 that is configured to grasp and secure the leaflets of the mitral valve. Thedevice1100 and corresponding methods of use are described in more detail in U.S. Patent Publication No. 2004/0030382, entitled “Methods and Apparatus For Cardiac Valve Repair”, which is incorporated herein by reference in its entirety. Additional leaflet grasping devices are described in U.S. Patent Publication No. 2004/0092962, U.S. Pat. No. 6,269,819, issued Aug. 7, 2001, and U.S. U.S. Pat. No. 6,461,366, issued Oct. 8, 2002, all of which are expressly incorporated by reference herein.
• Referring toFIG. 32, thedevice1100 is comprised of acatheter shaft1102 having adistal end1104 and aproximal end1106. Thecatheter shaft1102 is comprised of, among others, aconduit1108, a coaxialouter sheath1110, acentral lumen1111 through which a double-jaw grasper1113 may be inserted, and acentral guidewire lumen1105. Thecatheter shaft1102 can have additional lumens for the passage of one or more needles, as described more fully below.
• Toward thedistal end1104, an optional pair ofstabilizers1112 are fixedly mounted on theouter sheath1110 at theirproximal end1114 and fixedly attached toextenders1116 at theirdistal end1118. Thestabilizers1112 are shown in an outwardly bowed position, however they may be inwardly collapsed by either extending theextenders1116 or retracting theouter sheath1110. Bowing may be achieved by the reverse process.
• The double-jaw grasper1113 is comprised of two articulatingjaw arms1120 which may be opened and closed against the central shaft1122 (movement depicted by arrows) either independently or in tandem. Thegrasper1113 is shown in the open position inFIG. 32. The surfaces of thejaw arms1120 andcentral shaft1122 may be toothed, as shown, or may have differing surface textures for varying degrees of friction. Thejaw arms1120 each include a needle passageway1121 comprised of a cutout or a slot that extends at least partially along the length of eachjaw arm1120. As described in more detail below, the needle passageway provides a location where a needle can pass through thejaw arm1120 during manipulation of the papillary muscle.
• The above described components may be manipulated and controlled by ahandle1126 connected to theproximal end1106 of thecatheter shaft1102, as shown inFIG. 32 the handle1026 permits independent control of the components described above.
• Referring toFIGS. 33A-C, thedevice1100 may be used at least temporarily grasp and restrain the valve leaflets LF of the mitral valve MV. The double-jaw grasper1113 extends through the valve such that the leaflets LF1, LF2 are grasped from below. Thus, thedevice1100 is termed “atrial-ventricular.”
• Referring toFIG. 33A, theatrial device1100 may be stabilized against the mitral valve MV. Thestabilizers1112 may be positioned on the superior surface of the valve leaflets LF1, LF2 at a 90 degree angle to the line of coaptation. Thegrasper1113 may be advanced in its closed position from theconduit1108 between the leaflets LF1, LF2 until thejaw arms1120 are fully below the leaflets in the ventricle. At this point, thegrasper1113 may be opened and retracted so that thejaw arms1120 engage the inferior surface of the leaflets LF1, LF2. In this manner, the leaflets are secured between thestabilizers1112 and thejaw arms1120.
• Referring toFIG. 33B, thegrasper1113 will gradually close, drawing the leaflets LF1, LF2 together while maintaining a secure hold on the leaflets between thejaw arms1120 and thestabilizers1112. This may be accomplished by number of methods. For example, thestabilizers1112 may be gradually collapsed by either extending theextenders1116 or retracting theouter sheath1110. As thestabilizers1112 collapse, thejaw arms1120 may collapse due to spring loading to gradually close thegrasper1113. Alternatively, thejaw arms1120 may be actuated to close against thecentral shaft1122 applying force to thestabilizers1112 causing them to collapse. In either case, such action allows thestabilizers1112 to simultaneously vertically retract and withdraw from the leaflets as the leaflets are clamped between thejaw arms1120 and thecentral shaft1122. In this manner, the leaflets are effectively “transferred” to thegrasper1113. Referring toFIG. 33C, once thecollapsed stabilizers1112 are completely withdrawn, the leaflets LF1, LF2 are held in vertical opposition by thegrasper1113 in a more natural coaptation geometry.
• With reference now toFIG. 34, aneedle3410 is advanced from the left atrium into the left ventricle. Theneedle3410 can be passed through a lumen in thedevice1100 or it can be passed external to thedevice1100. In any event, theneedle3410 passes through a leaflet LF and into a papillary muscle PM. As mentioned, thejaw arms1120 have needle passageways1121 (shown inFIG. 32) that permit passage of the needle through thejaw arms1120.
• Theneedle3410 is attached to asuture3415 that extends distally through thedevice1100. Thesuture3415 is then anchored to the papillary muscle PM such that thesuture3415 provides an attachment for holding, pulling, or otherwise manipulating the papillary muscle PM. The tension in thesuture3415 can be adjusted to re-position the papillary muscle PM such that the leaflets LF contact one another to close the mitral valve. The same process can be performed with the other papillary muscle.
• With thesutures3415 holding the papillary muscles PM in a desired position, as shown inFIG. 35, the chordae CH may be cut. Thesutures3415 function as artificial chordae that retain the leaflets LF and papillary muscles PM in a desired orientation.
• A fixation device such as a clip can then be attached to the leaflets using methods and device described in U.S. Patent Publication Nos. 2004/0030382, filed Aug. 5, 2003, and 2004/0092962, filed May 19, 2003, U.S. Pat. No. 6,269,819, issued Aug. 7, 2001, and U.S. Pat. No. 6,461,366, issued Oct. 8, 2002, all of which are expressly incorporated by reference herein. Thesutures3415 can be attached to the clip3510 or directly to the leaflets LF. It should be appreciated that any quantity ofsutures3415 can be used as artificial chordae between the leaflets and the papillary muscles. It should be appreciated that the leaflet clips can also be used in conjunction with cutting, elongating, or shortening of the chordae pursuant to the methods described above.
• Prior to permanently placing the chordae or clips, the result can be previewed on ultrasound (TEE, ICE, echocardiography), to determine if the appropriate valve coaptation is restored. In addition, it is within the scope of the present invention to implant a mitral valve clip in addition to performed papillary muscle approximation or chordal implantation.
• As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope of the subject matter described herein. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.
• Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims (22)

What is claimed is:

1. A chordal replacement device comprising:

a proximal anchor comprising a flexible patch and a leaflet attachment device, wherein the flexible patch is affixed to an upper surface of a portion of a flailing leaflet with the leaflet attachment device;

a distal anchor extending and affixed to a distal attachment site in a ventricle; and

a flexible tether coupled to and tensioned between the proximal and distal anchors.

2. The device ofclaim 1, wherein the leaflet attachment device comprises a pair of expandable elements interconnected by a central attachment rod.

3. The device ofclaim 2, wherein the pair of expandable elements sandwich the flexible patch and the leaflet.

4. The device ofclaim 1, wherein the leaflet attachment device comprises an expandable element.

5. The device ofclaim 1, wherein the expandable element is self-deploying.

6. The device ofclaim 5, wherein the expandable element comprises a star-shaped barb, a mesh web, or a mesh ball.

7. The device ofclaim 1, wherein the proximal anchor further comprises a mesh stent deployable within an atrium.

8. The device ofclaim 7, wherein the mesh stent is coupled to a flexible rod that extends through a valve commissure into the ventricle.

9. The device ofclaim 8, wherein a distal end of the flexible rod couples to the distal anchor and provides consistent tension on the tether during a heart cycle.

10. The device ofclaim 8, wherein the flexible rod has a deflectable, spring-formed shape.

11. The device ofclaim 8, wherein the flexible rod is jointed.

12. The device ofclaim 1, wherein the distal anchor and tensioned flexible tether apply a downward force on the flailing leaflet.

13. The device ofclaim 1, wherein the distal anchor comprises a weight, barb, adhesive, screw, or fluid-filled element.

14. The device ofclaim 1, wherein the distal attachment site comprises a portion of the ventricle wall, ventricular septum or papillary muscle.

15. The device ofclaim 14, wherein the distal anchor fine-tunes the tension of the tether after the distal anchor is affixed to the distal attachment site.

16. The device ofclaim 15, wherein the distal anchor comprises a coil screw and wherein rotation of the coil screw fine-tunes the tension on the tether.

17. The device ofclaim 15, wherein the distal anchor comprises a balloon and wherein infusion of fluid into the balloon increases tension on the tether.

18. The device ofclaim 1, wherein the flexible tether has a length that can be adjusted to a desired tension to apply a downward force on the flailing leaflet.

19. The device ofclaim 1, wherein the flexible tether comprises one or more loops of a flexible material.

20. The device ofclaim 19, wherein the one or more loops are drawn together at a distal end region with an enclosed element.

21. The device ofclaim 20, wherein the enclosed element couples the one or more loops to the distal anchor.

22. The device ofclaim 21, wherein the one or more loops are coupled to the proximal and distal anchors such that the one or more loops self-equalize and evenly distribute tension on the flailing leaflets and on distal attachment site.

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