METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

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.

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.

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. 1Bshows a cross-sectional view of the heart wherein a flexible stent100is positioned at or near the mitral valve MV. The stent100is annular and is sized and shaped to be positioned on the annulus of the mitral valve. The stent100can transition between a collapsed state of reduced size and an expanded state of enlarged size relative to the collapsed state.

The flexible stent100can 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. The stent100is 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 the stent100, 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, the stent100is delivered using a delivery catheter10that is advanced from the inferior vena cava IVC into the right atrium RA. Once the catheter10reaches the anterior side of the interatrial septum IAS, a needle12may 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 the stent100. The catheter10can also approach the heart in other manners.

FIG. 2Ashows a cross-sectional view of the heart showing one or more magnets205positioned 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 a first magnet205into an individual's heart and securing it to the mitral valve MV annulus. At least a second magnet205is 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. The magnets205can be positioned on an annular band215(shown inFIG. 2B) that is sized and shaped to be implanted on the annulus of the mitral valve. The band215can be, for example, a stent.

In one embodiment, the magnets205or the annular band215are delivered using a delivery catheter10that 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. 3represents 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. 4show a cross-sectional view of the heart with a pair of flaps mounted at or near the mitral valve.FIG. 5Ashows a schematic side view of the mitral valve leaflets LF with a flap300positioned immediately below each leaflet. The flap300can be contoured so as to conform at least approximately to the shape of a leaflet, or the flap300can be straight as shown inFIG. 4.FIG. 5Bshows 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, a first flap300with an attachment end305and a free end310is provided. The attachment end305of the first flap300is secured to the inside wall of the ventricle below the mitral valve. A second flap315with an attachment end320and a free end330is provided and is also secured to the inside wall of the ventricle below the mitral valve. The first and second flaps300,315are oriented so that they face each other and the free ends310,330are 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. 6Ashows a cross-sectional view of the heart with a membrane ring610positioned at the mitral valve annulus.FIG. 6Bshows a schematic view of the membrane ring610, which includes an annular ring on which is mounted a membrane. The membrane includes a series of perforations615extending 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. 7Ashows 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-filled bladder600. The bladder600is 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. 7Bshows 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 or bladder630is positioned between the leaflets LF along the line of coaptation of the leaflets. The bladder630provides a surface against which at least a portion of the leaflets LF can seal against. The bladder630thus serves as a coaptation device for the leaflets. The bladder can be attached to various locations adjacent to or on the mitral valve.FIG. 7Dshows 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. 8shows a cross-sectional view of the heart wherein a one-way valve device700is 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 device700into the left atrium of an individual's heart proximal the mitral valve. The valve device700is 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. 9Ashows a prosthetic ring800that is sized to fit within a mitral valve annulus The ring includes one or more anchors805that extend around the periphery of the ring800. In addition, one or more struts810struts 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. 9Bshows another embodiment of a prosthetic ring807wherein a one-way valve815is 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. 10shows 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 a ring900sized to fit within a mitral valve annulus. At least two tongues910project from the ring900in 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 or more anchors920protrude 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. 11Ashows an exemplary embodiment of one or more clips1101that are positioned on free edges of the leaflets LF. Each of the clips1101has 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 a clip1101attached 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 the clips1101can attach to one another either momentarily or permanently to coapt the leaflets, as shown inFIG. 11C.

In another embodiment, shown inFIG. 11D, a single clip1101is attached to one of the leaflets. The clip1101is sufficiently long to increase the likelihood that the clip1101will 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. 12shows a schematic, cross-sectional view of the heart with a wedge1205positioned below at least one of the leaflets of the mitral valve. The wedge1205can be positioned below one or both of the leaflets. The wedge1205is sized to fit under the valve leaflet and caudal the annulus of the heart valve. The wedge1205can 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. 13Ashows 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, a synthetic chord1005of greater length than the free length of chordae is introduced into the heart chamber. One end of the synthetic chordae1005is connected to a wall1305of 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 the chord1005that is attached the wall1305can have any of a variety of devices that facilitate such attachment.FIGS. 13B and 13Cshow enlarged views of attachment devices contained within box13ofFIG. 13A. The attachment devices can be used to attach the chord1005to the wall1305. InFIG. 13B, the attachment device1310is an enlarged ball having a distal trocar for penetrating the wall1305. InFIG. 13C, the attachment device1310is a hook that is configured to penetrate through the wall1305. It should be appreciated that the attachment device1310can 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, a chordal replacement device3805can include a laterally-stabilized spring or flexible rod. In one embodiment, the device3805can include a first portion3810that receives and/or is movable with respect to a second portion3815. The first and second portions3810,3815can be surrounded by a spring3820. Each of the first and second portions3810,3815of the device3805can have a platform region3825,3830, respectively between which the spring3820extends. The platform regions3825,3830can 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, the platform regions3825,3830can also each have one or more barbs3835or another fixation device on an external surface that can implant and attach the device3805between 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.

The chordal replacement device3805can be delivered into the left atrium through a guide catheter3840(seeFIG. 38B). A tether3845can hold the device3805normal to the tip of the guide catheter3840. The tether3845can be threaded through the guide catheter3840, through the implant3805, and back out the guide catheter3840. When the procedure is completed, the tether3845can be pulled out of the guide catheter3840from either end releasing the implant, allowing deployment. Other mechanisms of attachment to the implant3805are considered herein. For example, the tether3845can 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 the implant3805. The threaded region of the implant can be rotatable such that the implant3805can 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, a second tether3850can be used to longitudinally compress the spring3820between the platforms3825,3830such that they approximate one another and the first portion3810receives a greater length of the second portion3815than it receives in the uncompressed state and the overall length of the device3805is reduced as defined by the distance between the barbs. This second tether3850can thread through the guide catheter3840in a similar manner as the first tether3845as described above. The second tether3850can be tensioned to compress the spring3820and after removal can be withdrawn similarly as the first tether3845. In an embodiment, a barb3835can be planted into a portion of the flailing valve leaflet and another barb3835can 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 the barbs3835into the desired locations.

The device3805can exert a force between the atrium roof and the valve leaflet through the spring3820to 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-39O, a chordal replacement device3905can include a clip3910, a distal anchor3915and a tether3920extending therebetween. The clip3910can attach to a portion of a flailing leaflet LF and the distal anchor3915can extend into the ventricle such that the flailing leaflet is held down. For example, the anchor3915can be implanted in the left ventricular wall or septum or papillary head or other appropriate tissue site. The length of the tether3920can be variable and/or adjusted such that the tension applied to the leaflet LF by the chordal replacement device3905is tailored to an individual patient's needs. For example, once the clip3910is positioned, the tether3920can be tensioned, tied and trimmed as will be described in more detail below.

The clip3910can 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, the clip3910can 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. The clip3910can have surface feature3950, such as small barbs or a textured surface, that aids in the capture of the leaflet LF upon deforming the clip3910to the leaflet LF. As best shown inFIG. 39A, the clip3910can also include an eyelet, aperture or other attachment feature3945that provides a location for coupling to or extending the tether3920through a portion of the clip3910. The distal anchor3915can similarly include an eyelet, aperture or attachment feature3945that provides a location for the tether3920to couple to or extend through a portion of the anchor3915(seeFIG. 39A, for example).

The anchor3915can vary in configuration and can include a weight, barb, corkscrew, adhesive or other mechanism such that the tether3920extends down and is secured in place within the ventricle. In an embodiment, the anchor3915extends into the ventricle from the clip3910and is secured to the bottom of the ventricle or toward the ventricular septum or papillary head. In an embodiment, the barbs of the anchor3915can 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, the tether3920can attach to the clip3910in a variety of ways. The clip3910can include an attachment feature3945that provides a location for coupling the clip3910to the tether3920. For example and as shown inFIG. 39D-39H, a knot or crimp3930can be applied to one end of the tether3920such that end will lodge into a portion of the clip3910or will lodge into the attachment feature3945. The opposite, unknotted end of the tether3920can extend through the delivery catheter3960and be retracted until the crimp3930lodges with the attachment feature3945on the clip3910, which is attached to the leaflet LF. The delivery catheter3960can be used to deploy the clip3910to the leaflet (FIG. 39E) and can then be withdrawn (FIG. 39F). At this stage the tether3920can still have both ends extending outside the body (FIG. 39G). An anchor3915also coupled to the tether3920can be loaded over the tether3920and delivered to the ventricle as will be described in more detail below.

In another embodiment shown inFIG. 39J-39M, the delivery system3955for the chordal replacement device3905can include a guide catheter3966having a lumen3965for a clip delivery catheter3970and a lumen3975for an anchor pusher or mandrel3980used to push the anchor3915out of the delivery system3955. The anchor3915is shown as a barbed anchor, but it should be appreciated that other configurations are considered herein. The anchor3915can be attached to a distal end of the mandrel3980such as by corresponding threads3990or another coupling mechanism. Upon being pushed out the distal end of the guide catheter3966, the anchor3915can be uncoupled from the mandrel3980(such as by an unthreading rotation) and released in its position within the heart. Alternatively, the anchor3915can be unattached to the mandrel3980and simply pushed out the distal end of the guide catheter3966. Once the anchor3915is implanted, the mandrel3980can be withdrawn.

It should be appreciated that the clip3910can be deployed prior to, during or after delivery of the anchor3915. The embodiments ofFIGS. 39D-39HandFIG. 39Killustrate the deployment of the clip3910prior to the anchor3915being delivered.FIGS. 39L-39Millustrate an embodiment in which the clip3910is deployed after the anchor3915is delivered.

As mentioned above, once the clip3910is positioned on the leaflet LF and the anchor3915deployed and secured within the ventricle, the tether3920can be tensioned. For example, the tether3920can be pulled manually to tension an end of the tether3920extending outside the body, to the desired tension to hold the leaflet LF down. Tension on the tether3920can be tuned and adjusted until an appropriate tension on the leaflet LF is achieved evidenced by the tether3920simulating 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, the tether3920can be clamped and cut to remove the excess length of the tether3920.FIGS. 39N-39Oillustrate an embodiment of a dual-function cutting clamp3935having the tether3920extending therethrough. The cutting clamp3935can have dual functions and can be used to clamp onto the tether3920to secure it near the distal end and it can also be used to cut the tether3920proximal of the secured section. As best shown inFIG. 39O, the cutting clamp3935can have an outer shell3937that can be coupled or attached to the anchor3915. The shell3937of the cutting clamp3935can have apertures or slots3939at opposite ends through which the tether3920can extend into an inner region of the shell3937. From one end of the shell3937, the tether3920extends towards the clip3910. At the opposite end of the shell3937, the tether3920extends back through the delivery catheter3970to the outside of the body. The cutting clamp3935can also include an aperture or slot3941through which an actuator line3943can pass and extend to the outside of the body. The actuator line3943can be actuated to effect clamping and/or cutting of the tether3920with the cutting clamp3935.

Still will respect toFIG. 39O, the cutting clamp3935, which may or may not already be coupled to the anchor3915can be actuated such that the tether3920is engaged by a ratcheting clamp mechanism. The ratcheting clamp mechanism prevents the release of the tension on the tether3920. The ratcheting clamp mechanism can include opposing clamp elements3946that extend inward from a ratchet recess3947open at an inner surface of the shell3937. The opposing clamp elements3946have textured surfaces at one end that are designed to come together to releasably engage the tether3920. At an opposite end the opposing clamp elements3946can have a ratchet mechanism3949that engages corresponding features in the ratchet recess3947of the shell3937. The opposing clamp elements3946can be actuated by pulling the actuator line3943at the outside of the body. The actuator line3943engages the opposing clamp elements3946such that they extend out from the ratchet recess3947and approach one another until the tether3920is caught between their textured surfaces. After the opposing clamp elements3946are engaged with one another and the tension on the tether3920is maintained, the actuation line3943can be actuated further until the opposing cutting elements3951are engaged by the actuation line3943, extend from their respective ratchet recess3947until their cutting surfaces come in contact to cut the tether3920therebetween. Once the tether3920is cut by the opposing cutting elements3951the actuation line3943can be released and the loose end of the tether3920can be removed from outside the body. In an embodiment, multiple chordal replacement devices3905can be used to attach to the chordae on the opposite or same side as the flailing leaflet. The second chordal replacement device3905can incorporate a similar cutting clamp as described above.

In another embodiment as shown inFIG. 40A-40B, a chordal replacement device4005can include a flexible material or patch4010that can be attached to the valve leaflet LF. A single strand of artificial chordae4015can loop through and underneath the patch4010. The strand of artificial chordae4015can include one, two, three or more individual loops and can be made of suture or another flexible material. The loops of artificial chordae4015can be drawn together at one end with a ring4020or other enclosed shape going through the loops of artificial chordae4015. The ring4020can 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 of artificial chordae4015can be a single strand of material that freely slides through the patch4010and the ring4020such that the loops4015can self-equalize to evenly distribute the load. A single loop4015can thread through the patch4010and the ring4020, for example three times, such that one loop is short and there are two other loops that are long. Pulling the ring4020away from the patch4010will 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 of artificial chordae4015are not fixed such that they can slip and distribute the force equally between them. This self-equalizing characteristic along with the flexible patch4010reduces the stress on the leaflet LF.

As shown inFIGS. 41A-41B, the device4005can be delivered to the valve leaflet (posterior or anterior). The patch4010can be folded and loaded into a delivery catheter4025such that the artificial chordae4015trail behind and are delivered through a guide catheter4030to the vicinity of the valve. A mandrel or pusher tube4035can push the patch4010out 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 a guidewire4141having a distal end that has a needle point. The needle point guidewire4141can be delivered using a protective sheath or delivery catheter4143that prevents pricking of the vessel as it is passed therethrough. The sheath or delivery catheter4143can 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. The needle point guidewire4141can be pre-formed to have a hook shape such that when it is advanced out of the sheath4143and extends through the leaflet LF it can curve upward back toward the sheath4143to form a hook. In another embodiment shown inFIGS. 41O-41P, the guidewire4141can include a thicker needle point4145attached to a more flexible cable4147or guidewire or thinner wire. The needle point4145can also be preformed such that it takes on a sharper curve or hook shape when advanced beyond the distal end of the delivery catheter4143. The needle point4145can be formed of a variety of materials such as Nitinol or other shape memory alloy or other suitable material.

Tension can be applied to the needle point guidewire4141such that the leaflet LF remains hooked and stabilized. Alternatively, the chordae can provide the resistance allowing the needle point guidewire4141to puncture the leaflet LF. The needle point guidewire4141as 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 the needle point guidewire4141, the sheath4143can be advanced distally back over the needle point as shown inFIG. 41N. The portion of the guidewire4141penetrating the leaflet LF is slowly withdrawn as the sheath4143is advanced distally.

The patch4010can be affixed to the valve leaflet LF by activating a leaflet attachment device4040through the guide catheter4030. In an embodiment, the leaflet attachment device4040can include a pair of expandable elements4045connected centrally by a rod4050. One or more of the expandable elements4045can have a sharp needle point4055. The patch4010can lie on top of the valve leaflet LF and the sharp needle point4055of the leading expandable element4045can pierce through the patch4010and the leaflet LF such that the leading expandable element4045emerges from the underneath side of the leaflet LF and the rod4050extends through the leaflet (seeFIGS. 41D and 41E). The patch4010on the upper surface of the leaflet LF can be sandwiched between the leading and trailing expandable elements4045of the leaflet attachment device4040. The leaflet attachment device4040and each of the expandable elements4045can be a shape-memory metal (e.g. Nitinol, Nitinol alloys) or some other spring material. The spring material of the expandable elements4045allows them to spring out as the leaflet attachment device4040is advanced from the distal end of the delivery catheter4025. The leaflet attachment can be facilitated by stabilizing the leaflet as described above. The position of the patch prior to securement of the expandable element4045can 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. 41Fshows a top view of an expandable element4045deployed 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, the leaflet attachment device4040can include expandable elements4045of a spring metal mesh. The spring metal mesh expandable element4045can form a web shape and flatten out as it is deployed. Alternatively, the Nitinol or other spring material can spring into an expandable element4045shaped like a mesh ball (seeFIG. 42C). Upon expansion, the mesh ball expandable element4045can protectively cover the sharp needle point4055on the underneath side of the valve leaflet. It should also be appreciated that the leaflet attachment device4040can include expandable elements4045that are a combination of configurations including flat mesh design, ball mesh design, a star-shaped design or other configuration. For example, one expandable element4045can have a star-shaped design and the other expandable element4045can 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. The patch4010can 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 one leaflet attachment device4040can be used to affix a patch4010to the valve leaflet LF. As shown inFIG. 43A, the patch4010can be attached to the atrial side of the valve leaflet LF with multiple leaflet attachment devices4040oriented side-by-side on the upper and lower surface of the leaflet LF. Using multiple leaflet attachment devices4040to affix the patch4010reduces stress in the leaflet LF, in part, due to distribution of forces across multiple attachment locations. As shown inFIG. 43B, the multiple leaflet attachment devices4040can be stacked and deployed in series from a delivery catheter4025. In another embodiment, the multiple leaflet attachment devices4040can be deployed using a guide wire between deployments of each leaflet attachment device4040. For example, the patch4010can be deployed followed by the first leaflet attachment device4040. The delivery catheter4025can be withdrawn leaving a guide wire4060in place. Another catheter with the second leaflet attachment device4040can then be advanced along the guide wire4060and the second leaflet attachment device4040deployed. The process can be repeated depending on the number of attachment devices desired to be deployed.

Once the patch4010is positioned and affixed to the leaflet LF, such as with the leaflet attachment device(s)4040, the loops of artificial chordae4015can be deployed distally within the ventricle such as to the ventricular wall, septum or papillary muscle. As shown inFIG. 44A, the delivery catheter4025that deployed the patch4010and leaflet attachment device(s)4040can be removed from the guide catheter4030leaving a guide wire4060attached to a ring4020through which the artificial chordae4015loop (attachment device(s) are not shown in the figure for simplicity). The guide wire4060can be previously looped through the ring4020, for example, during manufacturing. Another catheter can be advanced over the guide wire4060through the guide catheter4030. In an embodiment, the ring4020is attached to the distal end of the catheter4030as shown inFIG. 44B-44C. For example, the ring4020can be inserted or snapped into a flanged channel4065near the distal end of the catheter4030using the guide wire4060looped through the ring4020. The catheter4030with the ring4020in the channel4065can advance through the valve distally into the ventricle (seeFIG. 44D).

As shown inFIGS. 45A-45D, the ring4020with the attached loops of artificial chordae4015can be anchored to the ventricular wall or papillary muscle forming a distal attachment assembly4070of the chordal replacement device. In an embodiment a coil screw4075is coupled to the distal attachment assembly4070. The coil screw4075can be advanced like a cork screw through the distal end of the catheter4030into 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, the distal attachment assembly4070can be coupled to or can include a fillable element4080delivered through a hollow needle4085that pierces the ventricular wall (SeeFIGS. 45B-45C). The fillable element4080can include a balloon or mesh bag or other expandable element. A hardening agent or other material can be used to fill the element4080expanding it such that it anchors the artificial chordae4015and the distal attachment assembly4070to the ventricle. The needle4085can be retracted leaving the filled element4080inserted in the ventricle wall and coupled to the distal 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 screw4075or filled element4080) of the distal attachment assembly4070is attached to the ventricular wall or papillary muscle, the distal attachment assembly4070can be released from the guide catheter4030. The assembly4070can 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 the guide wire4060can extend all the way up through the guide catheter4030. As the delivery catheter4025is removed, the guide wire4060can still be looped through the ring4020. The guide wire4060can be removed before, during or after the delivery catheter4025is removed. The guide wire4060can be removed by pulling one end, allowing the trailing end to pull through the ring4020and then out of the guide catheter4030leaving the distal attachment assembly4070anchored in the ventricle and the artificial chordae4015extending up to the valve leaflet LF where the patch4010is affixed to the leaflet LF with the leaflet attachment device(s)4040.

Once the chordal replacement device is deployed, the tension of the artificial chordae4015can be adjusted. In an embodiment, a sensor4090such as a pin or pressure sensor can be used to adjust tension in the artificial chordae4015. The sensor4090can provide the user with information regarding contact between the guide catheter4030and the ventricular wall. As shown inFIG. 46A-46B, the sensor4090can include a pin4095near the distal tip of the catheter4030. The pin4095is shown inFIG. 46Aas fully extended indicating no contact with the ventricular wall. Upon contact with the wall as shown inFIG. 46B, the pin4095can 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 the sensor4090indicates 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 screw4075or element4080) can be advanced into the ventricular wall to secure attachment. If the sensor4090indicates contact with the ventricular wall, but the echocardiogram suggests flail and/or prolapse and poor MR results, the catheter4030can be moved further down into the ventricle to increase tension on the artificial chordae4015and the test repeated. If the sensor4090indicates 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 the catheter4030can be moved proximally to release tension on the artificial 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 a coil screw4075that is advanced and locked. The distal attachment assembly4070can be rotated clockwise by the catheter4030to draw the ring4020slightly closer to the ventricular wall. The distal attachment assembly4070can also be rotated by the catheter4030in a counter-clockwise direction to push the ring4020away 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 the expandable element4080expands within the ventricular wall, the distal attachment assembly4070attached to the expandable element4080is pulled toward the ventricular wall. The material of the expandable element4080can be finitely expanded such that fine-tuning of the distance between the distal attachment assembly4070and the ventricular wall can be performed. As the expandable element4080is unexpanded the artificial chordae4015can pull the distal attachment assembly4070away from ventricular wall and the valve leaflet can rise slightly. Once gross adjustments are performed, fine-tuning the tension on the artificial chordae4015attached to the valve leaflet can be performed. The first part epoxy (i.e. prior to hardening) can be used to fill the expandable element4080and also fine-tune the positioning and tension on the chordae4015. 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 a ring4020and loops of artificial chordae4015attached to a rod4105extending from a spring material (e.g. shape-memory metal such as Nitinol or other material) that forms a stent-like mesh4100deployed in the left atrium, just above the mitral valve. The rod4105can be attached to the mesh4100and extend from the mesh4100through the mitral valve such as at one of the commissures into the ventricle. The rod4105can be straight or curved or jointed. The distal end of the rod4105can be attached to the ring4020such as by extending through the ring4020. Rod4105and mesh4100can be moved to adjust tension on the artificial chordae4015. Once in a desirable location and the desired tension is achieved, the mesh4100and rod4105can be secured within the atrium or to the valve leaflets, for example using the leaflet attachment devices4040discussed above (seeFIG. 49B; note the rod, ring and replacement chordae are not shown).

As shown inFIG. 50A, the rod4105and mesh4100can be delivered through a delivery catheter4025in which the mesh4100is collapsed. As mentioned above, the rod4105can be jointed. The joints4110can lock in place once the rod4105is deployed and/or can have limited travel around the joint4110. As shown inFIGS. 50C-50E, one or more of the rod joints4110can lock into place using a mechanical/physical feature incorporated within the joint4110. In an embodiment, one or more of the joints4110can have a surface feature4112such that when the rod4105rotates over the surface feature4112on the adjacent portion of the joint4110it can pop over and lock in place relative to the adjacent portion of the joint4110.

Even in the locked position, one or more of the joints4110can have limited travel around the joint4110to provide the artificial chordae4015with some degree of slack (seeFIG. 50B). The rod4105and mesh4100can passively rise and fall with the mitral annulus during the cardiac cycle. In diastole, when the annulus rises, excessive tension on the artificial chordae4015can be avoided due to this limited travel around the joint4110. In an embodiment, the top joint4110can 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 joint4110rather 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, the rod4105can be flexible so that it can fit in a delivery catheter4025and expand to its spring-formed shape when deployed from the delivery catheter4025. Flexibility of rod4105can be designed so that it provides a predictable spring force on the artificial chordae4015. The rod4105can deflect and provide consistent tension on the artificial chordae4015.

It should be appreciated that in addition to a chordal replacement system, the leaflet attachment devices4040described above can be used to attach a leaflet extension patch for the treatment of mitral valve prolapse or flail. As shown inFIGS. 52A-52C, the leaflet extension patch5210can be attached to the atrial side of the valve leaflet. The leaflet extension patch5210can be a stiff or a flexible material. The leaflet extension patch5210can 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, the leaflet extension patch5210can bridge any coaptation gap between the leaflets.

FIG. 52Ashows the leaflet extension patch5210during diastole. The patch5210can follow the leaflet downwards such that flow through the valve is not impeded. During systole, the leaflet extension patch5210can 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. 14which shows a cross-sectional view of the heart with a first and second anchor attached to a wall of the heart. The system includes a first anchor1410ahaving a screw portion1415for 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 a second anchor1410bhaving a screw portion1415bfor screwing into a wall of the heart and a connector portion. Also included is a tether1420having 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. 15shows a catheter1510that has been introduced into the heart. The catheter1510has an internal lumen through which the strengthening agent1512can 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 the strengthening agent1512is 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. 16shows 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 or sleeve1205into 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 or more magnets1705are implanted or otherwise attached to a wall1710of the left ventricle LV. One or more other magnets1715are implanted or otherwise attached to a wall1720of the right ventricle. The magnets1705and1715are attached to the walls1710and1720such that they assert an attractive magnetic force (as represented by the arrows1725inFIG. 17) toward each other. The magnetic force1725assists in remodeling of the left ventricle during pumping of the heart. That is, the magnets1705and1715are urged toward one another (thereby also urging the walls1710and1720toward 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. 18Ashows another embodiment of a procedure wherein magnets are implanted in the heart to geometrically reshape the annulus or the left ventricle. One or more magnets1705are implanted or otherwise attached to a first wall1710aof the left ventricle LV. One or more magnets1705are also implanted or otherwise attached to a second, opposed wall1710bof the left ventricle. The magnets on the opposed walls1710a,1710bexert an attractive magnetic force toward one another to draw the walls1710a,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. 18Bshows a side view of the heart with sets of magnets A, A1, B, and B1positioned 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 A1is placed within the left ventricle LV opposite magnet A. The magnetic force between A and A1maintains 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 B1are then delivered to another location selected within or adjacent to the heart. The set of magnets A/A1are attached to the set of magnets B/B1using at least one tether1805, as shown inFIG. 18B. The tether1805can be attached to either or both of the magnets A/A1at one end and to either of both of the magnets B/B1at an opposite end. When the set of magnets B/B1are 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. 18Bshows magnet B positioned in the LV and B1positioned in a blood vessel BV adjacent to the heart. The magnetic force between B and B1maintains the location of B and B1. Magnets B and B1are 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 B1can 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 B1or they may be attached after A and B1have 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 A1can also be a single magnet that extends through the interventricular septum. Moreover, only one of the magnets A or A1need be implanted. One or more magnets B and/or B2are 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 B1is 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 B1can 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 B2can alternately be implanted. Other possible combinations are the magnets A1and B or the magnets A1and 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 or more magnets1705are implanted in the walls1710of the left ventricle LV and/or the right ventricle RV, as shown inFIG. 19. The magnets1705are positioned in opposed locations on the walls1710and one or more tethers1905attach opposed pairs of magnets1705to one another. One or more of the tethers1905extend 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.

The tethers1905can be elastic so to exert an attractive force between the attached magnets1705and re-shape the left ventricle LV or annulus AN. Alternately, or in combination with elastic tethers, the tethers1905can 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 the tethers1905, the magnets1705exert 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. 20shows a cross-sectional view of the left ventricle LV with a tether2010positioned therein. The tether2010has 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. The tether2010is tensioned to pull the walls toward one another (as represented by the phantom lines2012inFIG. 20) and re-shape the left ventricle LV. It should be appreciated that the phantom lines2012inFIG. 20are 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 the tether2010and the location of attachment to the walls of the left ventricle LV. The tether may be inelastic or somewhat elastic.

The tether2010can 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 the tether2010. 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 a catheter2105having a sharpened distal end2110that is positioned within the left ventricle LV. The catheter2105can 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 sharpened distal end2110pierces the ventricular wall such that the distal end2110is positioned exterior to the ventricular wall. The catheter2105has an internal delivery lumen having an opening at the distal end2110. The patch2015is configured to be transported in a contracted state through the delivery lumen and delivered out of the opening at the distal end2110, where the patch2015expands 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, the patch2015is configured to act as a reservoir that receives a fluid material that can be delivered to the patch via the delivery lumen of the catheter2105. The fluid material has a first viscous state of sufficient fluidity such that the material can flow through the delivery lumen of the catheter2105and out of the distal end2110to the location of the patch2015. The fluid material changes to a second viscous state when positioned exterior to the ventricular wall at the patch2015. 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 the patch2015and 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, the catheter2105can then be disengaged from the patch2015such that the patch2015is disposed exterior to the ventricular wall. The patch2015can 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 the tether2010is attached to the patch2015. The catheter2105can be used to deliver the tether2010to the patch2015or, alternately, a second catheter can be used. In one embodiment, the tether2010is already positioned in a delivery lumen of the catheter2105while the patch2015is being delivered. The catheter2105is then pulled back while the end of the tether2010remains attached to the patch2015to thereby let the tether2010out from the catheter2105, as shown inFIG. 23.

With reference now toFIG. 24, a second patch2415is deployed in or exterior to an opposed ventricular wall in a manner similar to that described above. The opposite end of the tether2010is then attached to the second patch2415such that the tether2010extends between the two patches, as shown inFIG. 20. Alternately, as shown inFIG. 24, a second tether2420is attached at a first end to the second patch2415. As shown inFIG. 25, the two tethers2010and2420can then be attached together at opposite ends from the patches, such as by using a clip2510, to form a single attachment tether between the patches2015and2415. The tethers2010and2420can be twisted or adjusted within the clip2510to tension the resulting attachment tether between the patches2415and2015and 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, a needle2610or delivery catheter is passed trans-thoracically into the left ventricle LV to deliver a patch2615to 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 the needle2610during delivery of the patch2615. Visualization means, such as fluoroscopy, can be used to visualize proper placement of the needle2610. 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. 27shows 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. 28shows 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 a spring2910, is mounted between the papillary muscles PM with a first end of the spring2910attached to a first papillary muscle and a second end of the spring2910attached to a second papillary muscle. The spring2910has a pre-load such that the spring2910provides a biasing force (represented by the arrows2915inFIG. 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 the spring2910can 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, a suture3010is mounted between the papillary muscles PM with a first end of the suture3010attached to a first papillary muscle and a second end of the suture3010attached to a second papillary muscle. The suture3010can be attached to the papillary muscles in various manners. For example, an attachment device3015, such as an anchor, cuff or sleeve, can be positioned around or partially around each of the papillary muscles. The ends of the suture3010are attached to the attachment devices3015to secure the suture3010to the suture to the papillary muscles.

The suture3010is tensioned such that it provides a force that pulls the papillary muscles PM toward one another. The suture3010can be tensioned, for example, by twisting the suture3010to 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 the suture3010. 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. A snare3110comprised 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. The snare3110is 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 or more clips3610are clipped to each of the papillary muscles PM. The structure of the clips3610can vary. A tether3615attaches the clips3610to one another. The tether3615is cinched to shorten the length of the tether3615and 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 or more clips3610are clipped to opposed walls of the left ventricle LV. The clips3610can be delivered to the left ventricle using a delivery 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. 32shows a leaflet grasping device1100that is configured to grasp and secure the leaflets of the mitral valve. The device1100and 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. Pat. No. 6,461,366, issued Oct. 8, 2002, all of which are expressly incorporated by reference herein.

Referring toFIG. 32, the device1100is comprised of a catheter shaft1102having a distal end1104and a proximal end1106. The catheter shaft1102is comprised of, among others, a conduit1108, a coaxial outer sheath1110, a central lumen1111through which a double-jaw grasper1113may be inserted, and a central guidewire lumen1105. The catheter shaft1102can have additional lumens for the passage of one or more needles, as described more fully below.

Toward the distal end1104, an optional pair of stabilizers1112are fixedly mounted on the outer sheath1110at their proximal end1114and fixedly attached to extenders1116at their distal end1118. The stabilizers1112are shown in an outwardly bowed position, however they may be inwardly collapsed by either extending the extenders1116or retracting the outer sheath1110. Bowing may be achieved by the reverse process.

The double-jaw grasper1113is comprised of two articulating jaw arms1120which may be opened and closed against the central shaft1122(movement depicted by arrows) either independently or in tandem. The grasper1113is shown in the open position inFIG. 32. The surfaces of the jaw arms1120and central shaft1122may be toothed, as shown, or may have differing surface textures for varying degrees of friction. The jaw arms1120each include a needle passageway1121comprised of a cutout or a slot that extends at least partially along the length of each jaw arm1120. As described in more detail below, the needle passageway provides a location where a needle can pass through the jaw arm1120during manipulation of the papillary muscle.

The above described components may be manipulated and controlled by a handle1126connected to the proximal end1106of the catheter shaft1102, as shown inFIG. 32the handle1026permits independent control of the components described above.

Referring toFIGS. 33A-C, the device1100may be used at least temporarily grasp and restrain the valve leaflets LF of the mitral valve MV. The double-jaw grasper1113extends through the valve such that the leaflets LF1, LF2are grasped from below. Thus, the device1100is termed “atrial-ventricular.”

Referring toFIG. 33A, the atrial device1100may be stabilized against the mitral valve MV. The stabilizers1112may be positioned on the superior surface of the valve leaflets LF1, LF2at a 90 degree angle to the line of coaptation. The grasper1113may be advanced in its closed position from the conduit1108between the leaflets LF1, LF2until the jaw arms1120are fully below the leaflets in the ventricle. At this point, the grasper1113may be opened and retracted so that the jaw arms1120engage the inferior surface of the leaflets LF1, LF2. In this manner, the leaflets are secured between the stabilizers1112and the jaw arms1120.

Referring toFIG. 33B, the grasper1113will gradually close, drawing the leaflets LF1, LF2together while maintaining a secure hold on the leaflets between the jaw arms1120and the stabilizers1112. This may be accomplished by number of methods. For example, the stabilizers1112may be gradually collapsed by either extending the extenders1116or retracting the outer sheath1110. As the stabilizers1112collapse, the jaw arms1120may collapse due to spring loading to gradually close the grasper1113. Alternatively, the jaw arms1120may be actuated to close against the central shaft1122applying force to the stabilizers1112causing them to collapse. In either case, such action allows the stabilizers1112to simultaneously vertically retract and withdraw from the leaflets as the leaflets are clamped between the jaw arms1120and the central shaft1122. In this manner, the leaflets are effectively “transferred” to the grasper1113. Referring toFIG. 33C, once the collapsed stabilizers1112are completely withdrawn, the leaflets LF1, LF2are held in vertical opposition by the grasper1113in a more natural coaptation geometry.

With reference now toFIG. 34, a needle3410is advanced from the left atrium into the left ventricle. The needle3410can be passed through a lumen in the device1100or it can be passed external to the device1100. In any event, the needle3410passes through a leaflet LF and into a papillary muscle PM. As mentioned, the jaw arms1120have needle passageways1121(shown inFIG. 32) that permit passage of the needle through the jaw arms1120.

The needle3410is attached to a suture3415that extends distally through the device1100. The suture3415is then anchored to the papillary muscle PM such that the suture3415provides an attachment for holding, pulling, or otherwise manipulating the papillary muscle PM. The tension in the suture3415can 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 the sutures3415holding the papillary muscles PM in a desired position, as shown inFIG. 35, the chordae CH may be cut. The sutures3415function 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. The sutures3415can be attached to the clip3510or directly to the leaflets LF. It should be appreciated that any quantity of sutures3415can 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.

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.