Patent Abstract:
The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.

Full Description:
[0001]    This application claims priority to provisional U.S. Patent Application No. 62/014,060, titled “Mitral Valve Implants for the Treatment of Valvular Regurgitation” and filed Jun. 18, 2014. The entire disclosure of the foregoing priority application is hereby incorporated by reference herein for all purposes. 
     
    
     BACKGROUND 
       [0002]    1. Field 
         [0003]    The present invention generally provides improved medical devices, systems, and methods, typically for treatment of heart valve disease and/or for altering characteristics of one or more valves of the body. Embodiments of the invention include implants for treatment of mitral valve regurgitation. 
         [0004]    The human heart receives blood from the organs and tissues via the veins, pumps that blood through the lungs where the blood becomes enriched with oxygen, and propels the oxygenated blood out of the heart to the arteries so that the organ systems of the body can extract the oxygen for proper function. Deoxygenated blood flows back to the heart where it is once again pumped to the lungs. 
         [0005]    The heart includes four chambers: the right atrium (RA), the right ventricle (RV), the left atrium (LA) and the left ventricle (LV). The pumping action of the left and right sides of the heart occurs generally in synchrony during the overall cardiac cycle. 
         [0006]    The heart has four valves generally configured to selectively transmit blood flow in the correct direction during the cardiac cycle. The valves that separate the atria from the ventricles are referred to as the atrioventricular (or AV) valves. The AV valve between the left atrium and the left ventricle is the mitral valve. The AV valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and thence to the lungs; blood returns to the left atrium via the pulmonary veins. The aortic valve directs flow through the aorta and thence to the periphery. There are normally no direct connections between the ventricles or between the atria. 
         [0007]    The mechanical heartbeat is triggered by an electrical impulse which spreads throughout the cardiac tissue. Opening and closing of heart valves may occur primarily as a result of pressure differences between chambers, those pressures resulting from either passive filling or chamber contraction. For example, the opening and closing of the mitral valve may occur as a result of the pressure differences between the left atrium and the left ventricle. 
         [0008]    At the beginning of ventricular filling (diastole) the aortic and pulmonary valves are closed to prevent back flow from the arteries into the ventricles. Shortly thereafter, the AV valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after ventricular systole (i.e., ventricular emptying) begins, the tricuspid and mitral valves normally shut, forming a seal which prevents flow from the ventricles back into the corresponding atria. 
         [0009]    Unfortunately, the AV valves may become damaged or may otherwise fail to function properly, resulting in improper closing. The AV valves are complex structures that generally include an annulus, leaflets, chordae and a support structure. Each atrium interfaces with its valve via an atrial vestibule. The mitral valve has two leaflets; the analogous structure of the tricuspid valve has three leaflets, and opposition or engagement of corresponding surfaces of leaflets against each other helps provide closure or sealing of the valve to prevent blood flowing in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as malcoaptation, and may allow blood to flow backward through the valve (regurgitation). Heart valve regurgitation can have serious consequences to a patient, often resulting in cardiac failure, decreased blood flow, lower blood pressure, and/or a diminished flow of oxygen to the tissues of the body. Mitral regurgitation can also cause blood to flow back from the left atrium to the pulmonary veins, causing congestion. Severe valvular regurgitation, if untreated, can result in permanent disability or death. 
         [0010]    2. Description of the Related Art 
         [0011]    A variety of therapies have been applied for treatment of mitral valve regurgitation, and still other therapies may have been proposed but not yet actually used to treat patients. While several of the known therapies have been found to provide benefits for at least some patients, still further options would be desirable. For example, pharmacologic agents (such as diuretics and vasodilators) can be used with patients having mild mitral valve regurgitation to help reduce the amount of blood flowing back into the left atrium. However, medications can suffer from lack of patient compliance. A significant number of patients may occasionally (or even regularly) fail to take medications, despite the potential seriousness of chronic and/or progressively deteriorating mitral valve regurgitation. Pharmacological therapies of mitral valve regurgitation may also be inconvenient, are often ineffective (especially as the condition worsens), and can be associated with significant side effects (such as low blood pressure). 
         [0012]    A variety of surgical options have also been proposed and/or employed for treatment of mitral valve regurgitation. For example, open-heart surgery can replace or repair a dysfunctional mitral valve. In annuloplasty ring repair, the posterior mitral annulus can be reduced in size along its circumference, optionally using sutures passed through a mechanical surgical annuloplasty sewing ring to provide coaptation. Open surgery might also seek to reshape the leaflets and/or otherwise modify the support structure. Regardless, open mitral valve surgery is generally a very invasive treatment carried out with the patient under general anesthesia while on a heart-lung machine and with the chest cut open. Complications can be common, and in light of the morbidity (and potentially mortality) of open-heart surgery, the timing becomes a challenge—sicker patients may be in greater need of the surgery, but less able to withstand the surgery. Successful open mitral valve surgical outcomes can also be quite dependent on surgical skill and experience. 
         [0013]    Given the morbidity and mortality of open-heart surgery, innovators have sought less invasive surgical therapies. Procedures that are done with robots or through endoscopes are often still quite invasive, and can also be time consuming, expensive, and in at least some cases, quite dependent on the surgeon&#39;s skill. Imposing even less trauma on these sometimes frail patients would be desirable, as would be providing therapies that could be successfully implemented by a significant number of physicians using widely distributed skills. Toward that end, a number of purportedly less invasive technologies and approaches have been proposed. These include devices which seek to re-shape the mitral annulus from within the coronary sinus; devices that attempt to reshape the annulus by cinching either above to below the native annulus; devices to fuse the leaflets (imitating the Alfieri stitch); devices to re-shape the left ventricle, and the like. 
         [0014]    Perhaps most widely known, a variety of mitral valve replacement implants have been developed, with these implants generally replacing (or displacing) the native leaflets and relying on surgically implanted structures to control the blood flow paths between the chambers of the heart. While these various approaches and tools have met with differing levels of acceptance, none has yet gained widespread recognition as an ideal therapy for most or all patients suffering from mitral valve regurgitation. 
         [0015]    Because of the challenges and disadvantages of known minimally invasive mitral valve regurgitation therapies and implants, still further alternative treatments have been proposed. Some of the alternative proposals have called for an implanted structure to remain within the valve annulus throughout the heart beat cycle. One group of these proposals includes a cylindrical balloon or the like to remain implanted on a tether or rigid rod extending between the atrium and the ventricle through the valve opening. Another group relies on an arcuate ring structure or the like, often in combination with a buttress or structural cross-member extending across the valve so as to anchor the implant. Unfortunately, sealing between the native leaflets and the full perimeter of a balloon or other coaxial body may prove challenging, while the significant contraction around the native valve annulus during each heart beat may result in significant fatigue failure issues during long-term implantation if a buttress or anchor interconnecting cross member is allowed to flex. Moreover, the significant movement of the tissues of the valve may make accurate positioning of the implant challenging regardless of whether the implant is rigid or flexible. 
         [0016]    In light of the above, it would be desirable to provide improved medical devices, systems, and methods. It would be particularly desirable to provide new techniques for treatment of mitral valve regurgitation and other heart valve diseases, and/or for altering characteristics of one or more of the other valves of the body. The need remains for a device which can directly enhance leaflet coaptation (rather than indirectly via annular or ventricular re-shaping) and which does not disrupt leaflet anatomy via fusion or otherwise, but which can be deployed simply and reliably, and without excessive cost or surgical time. It would be particularly beneficial if these new techniques could be implemented using a less-invasive approach, without stopping the heart or relying on a heart-lung machine for deployment, and without relying on exceptional skills of the surgeon to provide improved valve and/or heart function. 
       SUMMARY 
       [0017]    In some embodiments, disclosed herein is an implant for treating mal-coaptation of a heart valve. The implant can include one or more of a shape memory structure, a biocompatible membrane coupled to the structure, a hub placed on the proximal side of the implant and coupled to the membrane, one, two, or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular projection coupled to an anchoring device. The implant can be folded for delivery through a percutaneous catheter. A shape memory structure can include a shape memory spine, such as nitinol or PEEK for example. A part of the ventricular projection, such as the distal tip, can be radiopaque. The anchoring device could be active, or passive. The spine can include features such as microholes and microhooks for coupling to the membrane and tissue. 
         [0018]    Also disclosed herein is a steerable catheter that includes one or more of a steerable shaft, a rotatable handle that is coupled to a pullwire placed within the shaft to adjust the bend radius of the distal tip of the shaft depending on the amount of torque applied to the handle. In some embodiments, the diameter of the handle of the catheter is equal to the diameter of the steerable shaft, or no larger than the diameter of the steerable shaft. Also disclosed herein is a delivery catheter comprising one or more of the following: a rotatable handle coupled to a pullwire placed within a torqueable shaft to adjust the bend radius of the distal tip of the shaft of the catheter, a sheath designed to contain the implant when the implant is folded, and distal tip further comprising of locking features that enable coupling of delivery catheter to either a hub of an implant or to an anchor. In some embodiments, the catheter can also include a tearable and disposable funnel to aid in the folding of the implant. In some embodiments, the distal tip further comprises locking tabs which are naturally set to be in the unlocked position. The delivery catheter may be coupled to the annular hub of the implant which has features that accept the locking tabs of the delivery catheter. In some embodiments, a guidewire or another catheter may be inserted within the shaft to push the locking tabs to the companion features on the hub of the implant so that the catheter and the hub are locked. The catheter can also include a loop, such as wire running from the proximal handle to the distal tip such that the tension in the loop may be controlled via control on the handle. The delivery catheter may be coupled to the annular hub of the implant which has a cross pin. A guidewire or another catheter may be inserted within the shaft and the loop of wire is tensioned against the cross-pin and the guidewire such that the delivery catheter is locked to the hub of the implant until the tension on the loop is maintained. 
         [0019]    An implant can be operatively coupled to tissue, such as heart tissue, via a first coupling of the anchor to the delivery catheter, and a second coupling of the anchor to the implant hub where torque is applied to the delivery catheter to insert the anchor into the hub and the tissue. The first coupling can be uncoupled to retract the catheter. 
         [0020]    In some embodiments, commissure anchors can be delivered by one or more of the following steps: coupling an anchor to a shaft of a catheter, advancing the anchor and the catheter to an anchor site, delivering the anchor such that it engages with the implant and tissue, and uncoupling the anchor from the shaft. The shaft can be torqueable, and the engaging mechanism can apply torque to the shaft so that the anchor engages with the implant and tissue. The anchors can be made of shape memory materials and be compressed into the shaft of a catheter for delivery to the anchor site, where the distal tip of the catheter is shaped such that it pierces tissue. The anchors can be advanced after the delivery catheter first pierces the tissue and subsequently the catheter is retracted leaving the anchor in place. 
         [0021]    In some embodiments, disclosed is an implant for treating mal-coaptation of a heart valve. The implant can include one or more of the following: a removable shape memory structure, a biocompatible membrane coupled to the structure, a hub placed on the proximal side of the implant and coupled to the membrane, one, two, or more holes or perforations along the edge of the membrane on the proximal side, and a ventricular projection coupled to an anchoring device. The implant can also include at least one passageway, such as a passageway placed around the annular edge, and/or along the ventricular projection. In some embodiments, a plurality, such as 2, 3, 4, 5, or more anchors are delivered to couple an implant to the heart tissue. A delivery device can have a distal section that includes 1, 2, or more anchors rotationally coupled to a central spinning shaft. A spring-loaded mechanism can apply a pushing force so as to cause the anchors to exit the distal end. In some embodiments, the anchors can be housed in a housing with grooves on the inside diameter such that as the central spinning shaft rotates, the anchors may exit the distal end. The device can include one or more of, for example, a hollow shaft, a pointed end at the end of the hollow shaft, one, two, or more hollow barrels placed within the hollow shaft threaded by a wire, and a pusher at the proximal end such that when a force is applied to the pusher, the barrels exit the hollow shaft one by one. 
         [0022]    In some embodiments, disclosed herein is a steerable guidewire, comprising an elongate flexible body, having a longitudinal axis, a proximal end and a distal deflection zone; a control on the proximal end, for controllable deflection of the deflection zone; and a movable deflection element extending from the control to the deflection zone. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 10 French, 8 French, 6 French, or 4 French. The control can have an outside diameter that is no greater than the outside diameter of the body. Rotation of the control about the axis can cause lateral movement of the deflection zone. Rotation of the control in a first direction about the axis can cause proximal retraction of the deflection element. 
         [0023]    Also disclosed herein is an implantable coaptation assistance device, comprising a flexible body; a first, concave surface on the body, configured to restrain a posterior leaflet; a second, convex surface on the body, configured to contact an anterior leaflet; an arcuate, peripheral superior edge on the body defining an opening which faces away from the first surface; and a ventricular projection extending away from the body and configured to anchor in the ventricle. The device can also include an anchor on the ventricular projection. The anchor could be active or passive. The device can also include a flexible spine for supporting the arcuate peripheral edge. The spine can be removable in some cases. 
         [0024]    Also disclosed herein is an anchoring system for attaching a ventricular projection of an implantable coaptation device. The system can include a shoulder, having an aperture extending therethrough; a helical tissue anchor, extending distally from the hub; a first engagement structure on the anchor, for releasable engagement of a torque shaft; a second engagement structure on the torque shaft, for engaging the anchor; and an implant, having a hub dimensioned to receive the helical anchor through; wherein the torque shaft is configured for rotation to drive the helical anchor into tissue and secure the implant to tissue. The first engagement structure can be an aperture, and the second engagement structure can be a projection. The projection can be laterally moveable into and out of the aperture, such as in response to axial movement of an elongate element within the torque shaft. 
         [0025]    In some embodiments, a steerable guidewire is provided. The steerable guidewire can include an elongate flexible body, having a longitudinal axis, a proximal end and a distal deflection zone. The steerable guidewire can include a control on the proximal end, for controllable deflection of the deflection zone. The steerable guidewire can include a movable deflection element extending from the control to the deflection zone. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 10 French. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 6 French. In some embodiments, no portion of the guidewire has an outside diameter of greater than about 4 French. In some embodiments, the control has an outside diameter that is no greater than the outside diameter of the body. In some embodiments, rotation of the control about the axis causes lateral movement of the deflection zone. In some embodiments, rotation of the control in a first direction about the axis causes proximal retraction of the deflection element. 
         [0026]    In some embodiments, an implantable coaptation assistance device is provided. The implantable coaptation assistance device can include a flexible body. The implantable coaptation assistance device can include a first, concave surface on the body, configured to restrain a posterior leaflet. The implantable coaptation assistance device can include a second, convex surface on the body, configured to contact an anterior leaflet. The implantable coaptation assistance device can include an arcuate, peripheral superior edge on the body defining an opening which faces away from the first surface. The implantable coaptation assistance device can include a ventricular projection extending away from the body and configured to anchor in the ventricle. 
         [0027]    In some embodiments, the implantable coaptation assistance device can include an anchor on the ventricular projection. In some embodiments, the implantable coaptation assistance device can include an active anchor. In some embodiments, the implantable coaptation assistance device can include a passive anchor. In some embodiments, the implantable coaptation assistance device can include a flexible spine for supporting the arcuate peripheral edge. In some embodiments, the spine is removable. 
         [0028]    In some embodiments, an anchoring system for attaching a ventricular projection of an implantable coaptation device is provided. The anchoring system can include a shoulder, having an aperture extending therethrough. The anchoring system can include a helical tissue anchor, extending distally from the hub. The anchoring system can include a first engagement structure on the anchor, for releasable engagement of a torque shaft. The anchoring system can include a second engagement structure on the torque shaft, for engaging the anchor. The anchoring system can include an implant, having a hub dimensioned to receive the helical anchor through. In some embodiments, the torque shaft is configured for rotation to drive the helical anchor into tissue and secure the implant to tissue. In some embodiments, the first engagement structure is an aperture, and the second engagement structure is a projection. In some embodiments, the projection is laterally moveable into and out of the aperture. In some embodiments, the projection is laterally moveable into and out of the aperture in response to axial movement of an elongate element within the torque shaft. 
         [0029]    In some embodiments, an implantable coaptation assistance device is provided. The implantable coaptation assistance device can include a coaptation assist body comprising a first coaptation surface, an opposed second coaptation surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. The implantable coaptation assistance device can include a ventricular projection extending from the inferior edge. The implantable coaptation assistance device can include a first support extending through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. The implantable coaptation assistance device can include a second support extending through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. The implantable coaptation assistance device can include a passageway extending through at least a portion of the coaptation assist device sized to accept a steerable catheter therethrough. In some embodiments, the first support has a first configuration wherein the first support is generally linear and a second configuration wherein the first support is curved. In some embodiments, the first and second support are configured to permit percutaneous insertion of the implantable coaptation assistance device. 
         [0030]    In some embodiments, the passageway extends through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. In some embodiments, the steerable catheter comprises a distal tip configured to curve. In some embodiments, a handle of the steerable catheter is rotated to cause the distal tip to curve. In some embodiments, the first support comprises a shape memory material. In some embodiments, the first support is bonded to the coaptation assist body. In some embodiments, the coaptation assist body comprises a lumen sized to accept at least a portion of the first support. In some embodiments, the first support is removable. In some embodiments, the first support extends from the superior edge to the ventricular projection. In some embodiments, the passageway extends through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. In some embodiments, the second support comprises a shape memory material. In some embodiments, the second support is bonded to the coaptation assist body. In some embodiments, the coaptation assist body comprises a lumen sized to accept at least a portion of the second support. In some embodiments, the second support is removable. In some embodiments, the second support extends from the first lateral edge to the second lateral edge. In some embodiments, the first support is coupled to the second support. In some embodiments, the first support and the second support are coupled to a removable hub, the removable hub projecting from a surface of the coaptation assist body. 
         [0031]    In some embodiments, a kit comprising is provided. The kit can include an implantable coaptation assistance device. The implantable coaptation assistance device can include a coaptation assist body comprising a first coaptation surface, an opposed second coaptation surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge. The implantable coaptation assistance device can include a ventricular projection extending from the inferior edge. The implantable coaptation assistance device can include a passageway extending through at least a portion of the coaptation assist device sized to accept a steerable catheter therethrough. The kit can include a steerable catheter. In some embodiments, the steerable catheter is configured to pass through the mitral valve and curve toward the ventricular tissue, wherein the implantable coaptation assistance device is configured to be passed over the steerable catheter toward the ventricular tissue. 
         [0032]    In some embodiments, the passageway extends through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. In some embodiments, the steerable catheter comprises a distal tip configured to curve. In some embodiments, a handle of the steerable catheter is rotated to cause the distal tip to curve. In some embodiments, the passageway extends through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. 
         [0033]    In some embodiments, a method of using an implantable coaptation assistance device is provided. The method can include the step of inserting a coaptation assist body toward a heart valve. In some embodiments, the coaptation assist body comprising a first coaptation surface, an opposed second coaptation surface, each surface bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, a ventricular projection extending from the inferior edge. The method can include the step of manipulating a first support to cause the coaptation assist body assume a curved configuration. In some embodiments, the first support extending through at least a portion of the coaptation assist device between the superior edge and the ventricular projection. The method can include the step of manipulating a second support to cause the coaptation assist body assume a curved configuration. In some embodiments, the second support extending through at least a portion of the coaptation assist body between the first lateral edge and the second lateral edge. 
         [0034]    In some embodiment, manipulating a first support comprises releasing the coaptation assist body from a delivery catheter. In some embodiment, manipulating a second support comprises releasing the coaptation assist body from a delivery catheter. The method can include the step of guiding the coaptation assist body over a steerable catheter. The method can include the step of passing a steerable catheter from the ventricular projection toward the superior edge prior to inserting the coaptation assist body toward a heart valve. The method can include the step of moving a distal portion of the steerable catheter to curve around the posterior leaflet. The method can include the step of passing the coaptation assist device over the curve of the steerable catheter. In some embodiments, the steerable catheter is removed after the ventricular projection engages with ventricular tissue. In some embodiments, the steerable catheter remains in place as the ventricular projection is advanced toward the ventricular tissue. The method can include the step of removing the first support from the coaptation assist body. The method can include the step of removing the second support from the coaptation assist body. The method can include the step of engaging the ventricular projection with ventricular tissue. In some embodiments, the method is performed percutaneously. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0035]      FIG. 1A-1F  schematically illustrate some of the tissues of the heart and mitral valve, as described in the Background section and below, and which may interact with the implants and systems described herein 
           [0036]      FIG. 2A  illustrates a simplified cross-section of a heart, schematically showing mitral valve function during diastole. 
           [0037]      FIG. 2B  illustrates a simplified cross-section of a heart, schematically showing mitral valve function during systole 
           [0038]      FIGS. 3A-3B  illustrate a simplified cross-section of a heart, schematically showing mitral valve regurgitation during systole in the setting of mal-coaptation of the mitral valve leaflets. 
           [0039]      FIG. 4A  illustrates a stylized cross section of a heart, showing mitral valve mal-coaptation in the settings of functional mitral valve regurgitation. 
           [0040]      FIG. 4B  illustrates a stylized cross section of a heart, showing mitral valve mal-coaptation in the settings of degenerative mitral valve regurgitation. 
           [0041]      FIG. 5A  illustrates an embodiment of the coaptation assistance device. 
           [0042]      FIG. 5B  illustrates the various cross-sections the support structure may have along the section A-A of  FIG. 5A   
           [0043]      FIG. 5C  illustrates the various shapes of the anchors at the distal end of the ventricular projection. 
           [0044]      FIG. 5D  illustrates non-limiting examples of ranges of dimensions of the coaptation assistance device. 
           [0045]      FIG. 5E  illustrates a table of non-limiting examples of variations (materials, range of dimensions) of the support structure. 
           [0046]      FIG. 5F  illustrates an embodiment of the distal end of the ventricular projection. 
           [0047]      FIG. 5G  illustrates the position of the coaptation assistance device may be maintained by utilizing the shape of the coaptation assistance device to pinch the native posterior leaflet. 
           [0048]      FIG. 5H  illustrates an embodiment of how the coaptation assistance device may be secured through the posterior leaflet from the ventricular side. 
           [0049]      FIG. 6A  illustrates a steerable catheter. 
           [0050]      FIG. 6B  illustrates the position of the steerable catheter of  FIG. 6A  in the heart. 
           [0051]      FIG. 7A  illustrates a delivery catheter. 
           [0052]      FIG. 7B  illustrates an embodiment of a locking mechanism that locks the delivery catheter to the annular hub. 
           [0053]      FIG. 7C  illustrates another embodiment of a locking mechanism that locks the delivery catheter to the annular hub. 
           [0054]      FIG. 7D  illustrates the coupling of the coaptation assistance device, the delivery catheter, and a guidewire or steerable catheter. 
           [0055]      FIGS. 8A-8D  illustrate how the coaptation assistance device is folded and pulled into an implant sheath and delivered into the heart through the femoral access. 
           [0056]      FIGS. 8E-8G  illustrate how the delivery catheter and the implant sheath are placed so that the ventricular projection of the coaptation assistance device may be anchored. 
           [0057]      FIG. 8H  illustrates the coaptation assistance device that is fully open and the delivery catheter positioned over the annular hub for anchoring the annular hub to the annulus. 
           [0058]      FIG. 8I  illustrates an embodiment of an anchor that may be used to anchor the annular hub. 
           [0059]      FIG. 9A  illustrates a method to anchor the coaptation assistance device adjacent to the commissures via holes in the frame of the coaptation assistance device. 
           [0060]      FIG. 9B  illustrates the top view of the anchor and crossbar of  FIG. 9A . 
           [0061]      FIG. 10A  illustrates another embodiment of the delivery catheter having multiple lumens and connections to the implant. 
           [0062]      FIG. 10B  illustrates a cross section of the delivery catheter shown in  FIG. 1  OA. 
           [0063]      FIGS. 11A-B  illustrate various alternative embodiments of anchors. 
           [0064]      FIG. 11C  illustrates a delivery tube through which the anchors  11 A and  11 B may be delivered. 
           [0065]      FIG. 11D  illustrates how the anchor of  FIG. 11B  may appear after the anchoring process is completed. 
           [0066]      FIG. 12  illustrates a spineless implant design (figure is shown with a structure  1220  which is later withdrawn from the implant). 
           [0067]      FIGS. 13A-B  illustrate the initial stages of the delivery procedure for the spineless implant. 
           [0068]      FIGS. 14A-B  illustrate various types of anchoring methods for spineless implants. 
           [0069]      FIG. 15A  illustrates an embodiment of an anchor catheter enabled to deliver multiple anchors. This figure also illustrates multiple anchor designs. 
           [0070]      FIG. 15B  illustrates another embodiment of an anchor catheter enabled to deliver multiple anchors. 
           [0071]      FIGS. 15C-D  illustrate how the anchors in  15 B may be coupled to the tissue. 
           [0072]      FIG. 16A  illustrates another embodiment of an anchor catheter enabled to deliver multiple anchors. 
           [0073]      FIGS. 16B-C  illustrate how the tool in  FIG. 16A  may be used to deliver multiple anchors. 
           [0074]      FIG. 17A  illustrates another embodiment of a spineless implant. 
           [0075]      FIGS. 17B-E  illustrate how the embodiment of  FIG. 17A  may be anchored. 
       
    
    
     DETAILED DESCRIPTION 
       [0076]    The devices, systems and methods described within this disclosure are generally for the treatment of mitral valve regurgitation (MR). Mitral valve regurgitation occurs when the mitral valve does not prevent the backflow of blood from the left ventricle to the left atrium during the systolic phase. The mitral valve is composed of two leaflets, the anterior leaflet and the posterior leaflet, which coapt or come together during the systolic phase to prevent backflow. There are generally two types of mitral valve regurgitations, functional and degenerative regurgitations. Functional MR is caused by multiple mechanisms including abnormal or impaired left ventricular (LV) wall motion, left ventricular dilation and papillary muscle disorders. Degenerative MR is caused by structural abnormalities of the valve leaflets and the sub-valvular tissue including stretching or rupture of the chordae. Damaged chordae may lead to prolapsing of the leaflets which means that the leaflets bulge out (generally into the atrium), or become flail if the chordae become torn, leading to backflows of blood. As will be described below, the devices, system and methods in this disclosure provide a new coaptation surface over the native posterior valve such that the backward flow of blood is minimized or eliminated. 
         [0077]    Referring to  FIGS. 1A-1D , the four chambers of the heart are shown, the left atrium  10 , right atrium  20 , left ventricle  30 , and right ventricle  40 . The mitral valve  60  is disposed between the left atrium  10  and left ventricle  30 . Also shown are the tricuspid valve  50  which separates the right atrium  20  and right ventricle  40 , the aortic valve  80 , and the pulmonary valve  70 . The mitral valve  60  is composed of two leaflets, the anterior leaflet  12  and posterior leaflet  14 . In a healthy heart, the edges of the two leaflets oppose during systole at the coaptation zone  16 . 
         [0078]    The fibrous annulus  120 , part of the cardiac skeleton, provides attachment for the two leaflets of the mitral valve, referred to as the anterior leaflet  12  and the posterior leaflet  14 . The leaflets are axially supported by attachment to the chordae tendinae  32 . The chordae, in turn, attach to one or both of the papillary muscles  34 ,  36  of the left ventricle. In a healthy heart, the chordae support structures tether the mitral valve leaflets, allowing the leaflets to open easily during diastole but to resist the high pressure developed during ventricular systole. In addition to the tethering effect of the support structure, the shape and tissue consistency of the leaflets helps promote an effective seal or coaptation. The leading edges of the anterior and posterior leaflet come together along the zone of coaptation  16 , with a lateral cross-section  160  of the three-dimensional coaptation zone (CZ) being shown schematically in  FIG. 1E . 
         [0079]    The anterior and posterior mitral leaflets are dissimilarly shaped. The anterior leaflet is more firmly attached to the annulus overlying the central fibrous body (cardiac skeleton), and is somewhat stiffer than the posterior leaflet, which is attached to the more mobile posterior mitral annulus. Approximately 80 percent of the closing area is the anterior leaflet. Adjacent to the commissures  110 ,  114 , on or anterior to the annulus  120 , lie the left (lateral)  124  and right (septal)  126  fibrous trigones which are formed where the mitral annulus is fused with the base of the non-coronary cusp of the aorta ( FIG. 1F ). The fibrous trigones  124 ,  126  form the septal and lateral extents of the central fibrous body  128 . The fibrous trigones  124 ,  126  may have an advantage, in some embodiments, as providing a firm zone for stable engagement with one or more annular or atrial anchors. The coaptation zone CL between the leaflets  12 ,  14  is not a simple line, but rather a curved funnel-shaped surface interface. The first  110  (lateral or left) and second  114  (septal or right) commissures are where the anterior leaflet  12  meets the posterior leaflet  14  at the annulus  120 . As seen most clearly in the axial views from the atrium of  FIGS. 1C ,  1 D, and  1 F, an axial cross-section of the coaptation zone generally shows the curved line CL that is separated from a centroid of the annulus CA as well as from the opening through the valve during diastole CO. In addition, the leaflet edges are scalloped, more so for the posterior versus the anterior leaflet. Mal-coaptation can occur between one or more of these A-P (anterior-posterior) segment pairs A1/P1, A2/P2, and A3/P3, so that mal-coaptation characteristics may vary along the curve of the coaptation zone CL. 
         [0080]    Referring now to  FIG. 2A , a properly functioning mitral valve  60  of a heart is open during diastole to allow blood to flow along a flow path FP from the left atrium toward the left ventricle  30  and thereby fill the left ventricle. As shown in  FIG. 2B , the functioning mitral valve  60  closes and effectively seals the left ventricle  30  from the left atrium  10  during systole, first passively then actively by increase in ventricular pressure, thereby allowing contraction of the heart tissue surrounding the left ventricle to advance blood throughout the vasculature. 
         [0081]    Referring to  FIGS. 3A-3B  and  4 A- 4 B, there are several conditions or disease states in which the leaflet edges of the mitral valve fail to oppose sufficiently and thereby allow blood to regurgitate in systole from the ventricle into the atrium. Regardless of the specific etiology of a particular patient, failure of the leaflets to seal during ventricular systole is known as mal-coaptation and gives rise to mitral regurgitation. 
         [0082]    Generally, mal-coaptation can result from either excessive tethering by the support structures of one or both leaflets, or from excessive stretching or tearing of the support structures. Other, less common causes include infection of the heart valve, congenital abnormalities, and trauma. Valve malfunction can result from the chordae tendinae becoming stretched, known as mitral valve prolapse, and in some cases tearing of the chordae  215  or papillary muscle, known as a flail leaflet  220 , as shown in  FIG. 3A . Or if the leaflet tissue itself is redundant, the valves may prolapse so that the level of coaptation occurs higher into the atrium, opening the valve higher in the atrium during ventricular systole  230 . Either one of the leaflets can undergo prolapse or become flail. This condition is sometimes known as degenerative mitral valve regurgitation. 
         [0083]    In excessive tethering, as shown in  FIG. 3B , the leaflets of a normally structured valve may not function properly because of enlargement of or shape change in the valve annulus: so-called annular dilation  240 . Such functional mitral regurgitation generally results from heart muscle failure and concomitant ventricular dilation. And the excessive volume load resulting from functional mitral regurgitation can itself exacerbate heart failure, ventricular and annular dilation, thus worsening mitral regurgitation. 
         [0084]      FIG. 4A-4B  illustrate the backflow BF of blood during systole in functional mitral valve regurgitation ( FIG. 4A ) and degenerative mitral valve regurgitation ( FIG. 4B ). The increased size of the annulus in  FIG. 4A , coupled with increased tethering due to hypertrophy of the ventricle  320  and papillary muscle  330 , prevents the anterior leaflet  312  and posterior leaflet  314  from opposing, thereby preventing coaptation. In  FIG. 4B , the tearing of the chordae  215  causes prolapse of the posterior leaflet  344  upward into the left atrium, which prevents opposition against the anterior leaflet  342 . In either situation, the result is backflow of blood into the atrium, which decreases the effectiveness of left ventricle compression. 
         [0085]      FIG. 5A  illustrates an embodiment of a coaptation assistance device  500 . The coaptation assistance device  500  can include a coaptation assistance body  515 . The coaptation assist body  515  can include a first coaptation surface  535 . The first coaptation surface  535  can be disposed toward a mal-coapting native leaflet, in the instance of a mitral valve, the posterior leaflet when implanted. The coaptation assist body  515  can include a second coaptation surface  540 . The second coaptation surface  540  can be opposed to the first coaptation surface  535  as shown in  FIG. 5A . The second coaptation surface  540  can be disposed toward a mal-coapting native leaflet, in the instance of a mitral valve, the anterior leaflet when implanted. The first coaptation surface  535  and the second coaptation surface  540  can be bounded by a first lateral edge and a second lateral edge. The first coaptation surface  535  and the second coaptation surface  540  can be bounded by an inferior edge and a superior edge  545 . 
         [0086]    The first coaptation surface  535  and the second coaptation surface  540  are two sides of the same implant structure forming the coaptation assistance body  515 . The shape of the coaptation assistance body  515  may be characterized generally, in some embodiments, by the shape of the superior edge  545 , the shape of the first coaptation surface  535 , and the second coaptation surface  540 . 
         [0087]    The coaptation assistance device  500  can include a ventricular projection  525  as shown in  FIG. 5A . The ventricular projection  525  can extend from the inferior edge of the coaptation assistance body  515 . The ventricular projection  525  can be placed within the left ventricle when implanted. The ventricular projection  525  can provide an anchoring mechanism. The distal end  530  of the ventricular projection  525  generally provides the anchoring mechanism. 
         [0088]    The distal end  530  of the ventricular projection  525  may have different shapes as shown in  FIG. 5C .  FIG. 5C  shows five embodiments of the distal end  530 . It is noted that more variations are possible and they are not limited to the five embodiments shown in  FIG. 5C . Generally, and in other embodiments, there are two types of anchors. Examples of passive anchors are shown in embodiments  555 . 1  through  555 . 4  in  FIG. 5C . Passive anchors rely on entrapment behind and/or interference with the chordae. With respect to the passive anchors, in some embodiments, the largest dimension or the dimension responsible for entanglement (usually the width) with the chordae may range from 10 mm to 40 mm, such as 25 mm. 
         [0089]    Distal end  555 . 1  includes one or more prongs. The prongs can be an elongate rod which extends from a central hub as shown. In the illustrated embodiment, four prongs extend from the central hub. In other embodiments, one or more prongs extend from the central hub. The prongs can extend at an angle from the central hub, thereby increasing the surface area of the distal end  530 . Distal end  555 . 2  can be generally rectangular, rectangular, generally square, square, generally diamond shaped or diamond shaped. The distal end  555 . 2  can include one or more cut outs. The cut outs can increase the ability to grip tissue. In the illustrated embodiment, four cutouts are formed in the distal end. In other embodiments, one or more cut outs are provided. 
         [0090]    Distal end  555 . 3  includes one or more prongs. The prongs can be an elongate rod which extends from a central hub as shown. In the illustrated embodiment, two prongs extend from the central hub. In other embodiments, one or more prongs extend from the central hub. The prongs can extend at a right angle from the central hub, thereby increasing the surface area of the distal end  530 . 
         [0091]    Distal end  555 . 4  includes one or more barbs. The barbs can extends from a central hub as shown. The barbs can extend back toward the central hub. In the illustrated embodiment, three or more barbs extend from the central hub. In other embodiments, one or more barbs in one or more directions are provided. 
         [0092]    Distal end  555 . 5  includes one or more prongs, and is similar to the configuration shown as distal end  555 . 1 . Distal end  555 . 5  is an example of an active anchor. Active anchors may have features such as sharp points, barbs, or screws that may couple to the ventricular tissue. Active anchors may require a driving force, such as a torque, to embed within the tissue. Either passive or active anchors may be made of implant grade biocompatible materials such as silicone, PEEK, pebax, polyurethane. 
         [0093]    The size of the coaptation assistance device  500  is described in detail in  FIG. 5D . This figure shows the top view and front view of the coaptation assistance body  515  of the coaptation assistance device  500 . The three parameters “x”, “y” and “z” shown in the figure characterize the coaptation assistance device  500 . Non-limiting examples of ranges and magnitudes of these variables x, y, and z are shown in the “Dimension Table” in the figure. 
         [0094]    The coaptation assistance device  500  can include a support structure  505 . The support structure  505  can be referred to as a spine. The support structure  505  can define, at least in part, the shape of the coaptation assistance device  500 . 
         [0095]    Returning back to  FIG. 5A , the support structure  505  is shown by dotted lines. In some embodiments, the support structure  505  is made of a shape memory material such as but not limited to nitinol (NiTi), polyether ether ketone (PEEK) or other stiff polymer or fatigue resistant metal. The use of shape memory materials enables advantages described herein. For example, one advantage of a shape memory material is that its superelastic properties helps the coaptation assistance device  500  maintain its shape and functionality as a coaptation assistance device as the heart contracts and dilates and exerts pressure on the coaptation assistance device  500 . Another example of an advantage is that a shape memory material lends itself to percutaneous delivery methods which will be described herein. 
         [0096]    The support structure  505  can include one or more section. In some embodiments, the support structure  505  includes one section. In some embodiments, the support structure  505  includes two sections. In some embodiments, the support structure  505  includes three or more sections. In some embodiments, one or more sections of the support structure  505  can include one or more subsection. In the embodiment shown in  FIG. 5A , the support structure  505  includes two sections: a first section  505 . 2  and a second section  505 . 1 . 
         [0097]    The first section  505 . 2  can extend through at least a portion of the coaptation assistance device  500  between the superior edge  545  and the ventricular projection  525 . In some embodiments, the first section  505 . 2  can extend through the entire length between of the coaptation assistance device  500  between the superior edge  545  and the ventricular projection  525 . In some embodiments, the first section  505 . 2  extends from a location between the superior edge  545  and the inferior edge of the coaptation assistance body  515 . In some embodiments, the first section  505 . 2  extends from a location between the inferior edge of the coaptation assistance body  515  and the ventricular projection  525 . In some embodiment, the first section  505 . 2  extends along the coaptation assistance body  515  and continues on to support the ventricular projection  525 . 
         [0098]    The second section  505 . 1  can extend through at least a portion of the coaptation assist body  515  between the first lateral edge and the second lateral edge. In some embodiments, the second section  505 . 1  can extend through the entire length between of the first lateral edge and the second lateral edge. In some embodiments, the second section  505 . 1  extends from a location between the superior edge  545  and the inferior edge of the coaptation assistance body  515 . In some embodiments, the second section  505 . 1  extends from a location closer to the superior edge  545  than the inferior edge of the coaptation assistance body  515 . In some embodiments, the second section  505 . 1  extends from the first lateral edge toward the second lateral edge. In some embodiments, the second section  505 . 1  extends from the second lateral edge toward the first lateral edge. In some embodiments, the second section  505 . 1  extends along a section between the first lateral edge and the second lateral edge. In some embodiments, the second section  505 . 1  extends along the edge of the coaptation assistance device  500 . 
         [0099]    In some embodiments, the first section  505 . 2  and the second section  505 . 1  of the support structure  505  may be one integral piece or unitary structure. In some embodiments, the first section  505 . 2  and the second section  505 . 1  of the support structure  505  are separate components. In some embodiments, the first section  505 . 2  and the second section  505 . 1  may be two separate sections joined together by methods such as but not limited to crimping and laser welding. 
         [0100]    In some embodiments, the first section  505 . 2  is integrated within the coaptation assistance body  515  as described herein. In some embodiments, the first section  505 . 2  in integrated within the ventricular projection  525  as described herein. In some embodiments, the first section  505 . 2  is removable from the coaptation assistance body  515  as described herein. In some embodiments, the first section  505 . 2  is removable from the ventricular projection  525  as described herein. In some embodiments, the second section  505 . 1  is integrated within the coaptation assistance body  515  as described herein. In some embodiments, the second section  505 . 1  is removable from the coaptation assistance body  515  as described herein. In some embodiments, the first section  505 . 2  can have a first zone that is generally oriented substantially parallel to a longitudinal axis of the body  515 , and a second zone that is generally oriented substantially perpendicular to the longitudinal axis of the body  515  as illustrated. 
         [0101]    The support structure  505  that supports the shape of the ventricular projection  525  may have various cross sections as shown by section AA in  FIG. 5A  and illustrated in detail in  FIG. 5B . In  FIG. 5B , five embodiments of the cross-section are shown; however, it is noted that the embodiments of the cross section of the support structure  505  are not limited to these five. Cross-section  550 . 1  is circular or generally circular. Cross-section  505 . 2  is circular or generally circular. Cross-section  550 . 1  can have a larger cross-sectional area than cross-section  550 . 2 . Cross-section  550 . 3  comprises a plurality of circular or generally circular cross-sections. In the illustrated embodiment, seven circular or generally circular cross-sections collectively form the cross-section  550 . 3 . In other embodiments, two or more circular or generally circular cross-sections collectively form the cross-section  550 . 3 . Cross-section  550 . 3  can be in the form of a cable. Cross-section  550 . 4  is rectangular or generally rectangular. Cross-section  550 . 5  is rectangular or generally rectangular. Cross-section  550 . 4  can have a larger cross-sectional area than cross-section  550 . 5 . 
         [0102]    It is also noted that the first section  505 . 2  and the second section  505 . 1  may have different cross-sections as well. Each cross-section or embodiment shown in  FIG. 5B  may have certain advantages such as some cross sections may bend easily in one direction and not in another. Some other cross sections may have higher reliability properties than others. The characteristics of each type of cross-section is described along with the ranges and non-limiting possible dimensions of the cross section in Table 2 in  FIG. 5E  for two different materials nitinol and PEEK. Although various configurations are presented in Table 2, in some embodiments, cross-sections  550 . 4  and  550 . 5  can be utilized for both materials. 
         [0103]    When the coaptation assistance device  500  is placed within the heart, the coaptation assistance device  500  is such that, in some embodiments, the ventricular projection  525  will generally be placed within the left ventricle as shown in  FIG. 5G . The ventricular projection  525  provides a mechanism to anchor the coaptation assistance device  500  using the structure of the ventricles. An example of positioning of the coaptation assistance device  500  over the posterior leaflet is illustrated in  FIG. 5G . 
         [0104]    Bearing in mind that other examples of positioning are possible and are discussed elsewhere within this disclosure, in this particular example, the coaptation assistance device  500  is illustrated with a ventricular projection  525  that has a curved shape. The ventricular projection  525  and/or the first support  505 . 2  may be composed of shape memory materials, in which case the curved shape is retained after implantation. The curved shape may enable the coaptation assistance device  500  to stay in position as engages to the native posterior leaflet  14 . 
         [0105]      FIG. 5F  shows an embodiment of a passive anchor for the ventricular projection  525 . In this embodiment, a tube  560  running along the length of the ventricular projection  525  terminates in two tubes  565 . 1  and  565 . 2 , at the distal end of the coaptation assistance device  500 . The coaptation assistance device  500  may be delivered to the left side of the heart with straightening wires such that the two tubes  565 . 1  and  565 . 2  are approximately straight as shown by the dotted lines  565 . 1  and  565 . 2  (Position A) indicating that the straightening wires are in an advanced state. In some embodiments, the two tubes  565 . 1  and  565 . 2  may be made of shape memory material including but not limited to polyurethane, silicone, polyethylene, pebax and nylon. Without the straightening wires, the two tubes  565 . 1  and  565 . 2  may have a default shape that may be curled or coiled as shown by the solid lines  565 . 1  and  565 . 2  (Position B) in  FIG. 5F . 
         [0106]    After the implant is appropriately delivered and placed in the heart, the straightening wires may be withdrawn allowing the two tubes  565 . 1  and  565 . 2  to assume their default shape (Position B). The two tubes  565 . 1  and  565 . 2  may provide anchoring support due to entanglement with the chordae. The advantage of this type of anchoring is that the straightening wires may be advanced back into the two tubes  565 . 1  and  565 . 2 , straightening out the two tubes  565 . 1  and  565 . 2  and causing the two tubes  565 . 1  and  565 . 2  to disentangle from the chordae structure should it become necessary to reposition the coaptation assistance device  500  due to unsatisfactory placement. Although the example above describes two tubes  565 . 1  and  565 . 2 , it will be understood that there may be one, two, or more tubes. 
         [0107]    Yet another embodiment of anchoring the coaptation assistance device  500  is illustrated in  FIG. 5H . An active anchor may be coupled to the distal end of the ventricular projection  525 . After delivery of the implant, the active anchor may be driven through the posterior leaflet to couple to the coaptation assistance device  500  at the annular (atrial) section as shown. Methods to position and drive the anchors will be discussed herein. 
         [0108]    In another embodiment, the tips of the ventricular projection  525  may be radiopaque or echogenic to aid in placement and anchoring of the coaptation assistance device  500  while the coaptation assistance device  500  is being placed percutaneously. In such a procedure, fluoroscopic or ultrasound imaging modalities may be used to visualize the heart and the coaptation assistance device  500 . 
         [0109]    Returning back to  FIG. 5A , in another embodiment, the coaptation assistance device  500  can include a hub  510 . The hub  510  can have one or more purposes. One purpose can be to serve as an anchoring device as discussed herein. Another purpose can be to provide a mechanism to deliver the coaptation assistance device  500  percutaneously as discussed herein. In some embodiments, a hub (not shown) may be present at the distal end of the coaptation assistance device  500 . The hub can be located at the end of the ventricular projection  525 . The ventricular hub may be placed at the very distal tip of the distal end  530  of the ventricular projection  525 . To distinguish the two hubs, the hub  510  on the proximal side will be called simply the “hub”, the “annular hub” or the “proximal hub”. The hub at the distal tip of the ventricular projection will specifically be called the “ventricular hub”. 
         [0110]    Still referring to  FIG. 5A , the coaptation assistance body  515  of the coaptation assistance device  500  may be made of various biocompatible materials such as expanded polytetrafluoroethylene (ePTFE). This material provides the coaptation surface against which the anterior leaflet will close. The coaptation assistance body  515  of the coaptation assistance device  500  can be coupled to the support structure  505  such that the shape of the support structure  505  gives the general shape of the coaptation assistance device  500 . 
         [0111]    The shape of the coaptation assistance device  500  may be further supported by one or more ribs  546  (not shown). There may be one, two, or more ribs  546 . The ribs  546  may be made of various materials such as but not limited to suture, polypropylene, nylon, NiTi cable, NiTi wire and PEEK. The process of coupling the coaptation assistance body  515  of the coaptation assistance device  500  to the support structure  505  and/or the ribs  546  (if ribs  546  are present) is described herein. 
         [0112]    In some methods of manufacturing, the process may commence by slipping polyethylene (PE) tubes on the support structure  505  and/or the ribs  546  (if ribs  546  are present). This combination is placed between two ePTFE sheets after which heat and pressure are applied. The ePTFE bonds with the PE tubes due to pores in the ePTFE material into which the polyethylene material of the tube may melt into, creating a mechanical bond. Similarly, the PE tube material may melt into microholes in the support structure  505  and/or the ribs  546  when heat and compression are applied. The microholes in the support structure  505  and/or the ribs  546  may be deliberately placed to improve the bonding. 
         [0113]    In a variation of the process described above, PE sheets may be placed where no PE tubes may be present. In this variation, just as described above, a similar process of heat and compression is applied and a more uniform composite structure may be generated. In a further embodiment, the support structure  505  and/or the ribs  546  may have features such as microholes that couple the ePTFE membrane. The micro-hole diameters may be in the range of 0.005″ to 0.030″, for example. 
         [0114]    In a variation on the type of materials that may be used to make the coaptation assistance body  515  of the coaptation assistance device  500 , other materials such as but not limited to sponge material, polyurethane, silicone, bovine or porcine pericardium may be utilized. Bonding processes may include but may not be limited to heat bonding, suturing and gluing. 
         [0115]    Continuing to refer to  FIG. 5A , in some embodiments, the coaptation assistance device  500  has perforations or slots  520 . There may be one or multiple such perforations or slots  520 . These perforations  520  can serve the purpose of providing sites where anchors may be placed as discussed herein. 
         [0116]    One of the advantages of the coaptation assistance device  500  is that the coaptation assistance device  500  may be folded into a smaller structure. The coaptation assistance device  500  can be delivered percutaneously through a delivery catheter. In some embodiments, the support structure  505  is made of a shape memory material. When the coaptation assistance device  500  is unfolded inside the heart, the desired shape of the coaptation assistance device  500  is regained. Many embodiments now describe the various methods, devices and systems that are used to deliver the coaptation assistance device  500  into the heart. 
         [0117]    In some methods of use, the first support has a first configuration wherein the first support  505 . 2  is generally linear and a second configuration wherein the first support  505 . 2  is curved. In some methods of use, the first support  505 . 2  and the second support  505 . 1  are configured to permit percutaneous insertion of the coaptation assistance device  500 . 
         [0118]    The first few steps in the delivery procedure can be similar to those that are known in the art. The body of the patient is punctured for example in the lower torso/upper thigh area (groin) to get access to the femoral vein. Generally a trans-septal sheath and needle are inserted into the inferior vena cava and advanced up to the atrial septum, at which point a trans-septal puncture is performed and the trans-septal sheath is advanced into the left atrium. The needle is removed and the trans-septal sheath now provides access to the left atrium. More details about the above steps may be found in publicly available medical literature. 
         [0119]    The method can include various steps including those that are now described. The ventricular projection  525  of the coaptation assistance device  500  can be generally be placed within the left ventricle. It may be advantageous to guide the coaptation assistance device  500  to this location using various guiding techniques. For example a simple guidewire may be placed inside the trans-septal sheath and guided into the left ventricle by first entering the left atrium and going through the mitral valve. However, simple guidewire may not provide sufficient accuracy in placement of the ventricular projection  525 . 
         [0120]    In some embodiments, a method of placing a guidewire inside a steerable sheath may be used. The steerable sheath with a guidewire may be advanced through the trans-septal sheath and subsequently advanced through the mitral valve into the left ventricle where the steering ability of the steerable sheath would give additional support to position the guidewire appropriately. After the guidewire is placed, the steerable sheath requires to be removed prior to delivery of the coaptation assistance device. This method, although providing a more accurate positioning of the guidewire, involves an extra step of removing the steerable sheath. To improve on this process in terms of reducing the number of steps needed to perform the implantation, a various embodiments of a steerable sheath are disclosed herein. 
       Small Diameter Steerable Catheter 
       [0121]    Referring to  FIG. 6A , a small diameter steerable catheter  600  is illustrated. In some embodiments, the diameter  615  of a handle  610  of the steerable catheter  600  can be equal or substantially equal to the diameter  620  of the body  605  of the steerable catheter  600 . The steerable catheter  600  can have within it a pullwire  625 . When the handle  610  is rotated, for example in the direction of the arrow  632 , the distal portion of the steerable catheter  600  moves along arrow  635  from the linear position  630  to the curved position  640 . The curved position  640  may be beneficial to position the ventricular projection  625  as discussed herein. When the handle  610  is rotated, for example in the opposite direction of the arrow  632 , the distal portion of the steerable catheter  600  moves along from the curved position  640  to the linear position  630 . The linear position  630  of the steerable catheter  600  is shown by dotted lines, not to be confused with the pullwire  625  which is also shown in dotted lines. The linear position  630  may be beneficial for insertion or retraction of the steerable catheter  600  from the anatomy. 
         [0122]    In some embodiments, the diameter of the handle  610  can be equal to the diameter of the body  605 . This can be advantageous as the coaptation assistance device  500  may slide over the handle  610  and/or the body  605  smoothly after the steerable catheter  600  is placed in the ventricle. In some embodiments, the steerable catheter  600  can include an extension  612  at the proximal end which extends from the handle  610 . The extension  612  can be a wire or other elongate structure. The purpose of the extension  612  is to aid in the loading of other catheters or devices while allowing a physician or other operators to retain control of the steerable catheter  600 . Subsequent to loading of the other catheters or devices on the extension  612 , the steerable catheter  600  is utilized to guide the other catheters or devices. The length of the extension  612  can match or exceed the length of the catheter or device that is being loaded such that during the process of loading and delivering the other catheter or device, control of the steerable catheter  600  is retained. 
         [0123]    In some embodiments, the extension  612  may be coupled to the handle  610  only when necessary. For example if during a procedure, the medical team decides that a longer catheter is necessary, the extension  612  may be coupled to the handle  610 . Coupling mechanisms may include but are not limited to a threaded junction, a compression fit, or other mechanisms. 
         [0124]    Non-limiting examples of dimensions of the various subcomponents in some embodiments (the body  605 , handle  615 , extension  612 ) can be as follows: the diameter  620  of the body  605  may range from 2 to 10 Fr, such as 4 Fr, between about 2 Fr and about 6 Fr, between about 3 Fr and about 5 Fr, or less than 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, or 2 Fr. The handle  610  length may range in some cases from about ½″ to about 2″, such as about 1″, the handle linear travel (for pullwire activation) may range in some cases from about ⅛″ to about 3″, such as about ¾″. 
         [0125]    During the implantation process, some methods involve the guidewire or guidewire and steerable sheath. In some methods, the steerable catheter  600  may be advanced through the femoral access. Since the handle  610  is outside the patient&#39;s body, it may be rotated such that the distal portion of this steerable catheter  600  is placed in an appropriate position under the posterior leaflet. The extension  612  can be attached to the proximal end of the handle  610  to allow subsequent loading of the coaptation assistance device  500  and delivery catheter  700  prior to insertion into the trans-septal sheath  650 , described herein. This delivery catheter  700  may then be used as a guide for introducing the coaptation assistance device  500  as will be explained herein. 
         [0126]      FIG. 6B  illustrates the placement of the steerable catheter  600  in the heart. An embodiment of the trans-septal sheath  650  is shown. The left atrium  655 , left ventricle  660 , the posterior leaflet  665  of the mitral valve and the anterior leaflet  670  of the mitral valve are also shown. The steerable catheter  600  is shown going through the mitral valve and being positioned under the posterior leaflet  665 . It may be now appreciated how having the ability to deflect the distal potion of steerable catheter  600  can be advantageous so that an appropriate position of the coaptation assistance device  500  may be achieved. The distal portion of the steerable catheter  600  is able to curve under the posterior leaflet  665  as shown. In some methods, the next general step after placing the steerable catheter  600  is to deliver the coaptation assistance device  500  to the heart. Further embodiments are now described with regards to methods and devices to achieve delivery. 
         [0127]    Delivery Catheter 
         [0128]    Referring to  FIG. 7A , a delivery catheter  700  is now described. The function of the delivery catheter  700  is to carry the coaptation assistance device  500  to the heart. The shaft body  710  of the delivery catheter  700  can be torqueable and deflectable. The shaft body  710  is shown by the cross hatched lines. The delivery catheter  700  can include a handle  730 . The handle  730  can have rotation mechanisms, for example pull wires etc. The rotation mechanism can deflect and steer the shaft body  710 . Distal to the handle  730  is an implant sheath  725  which as explained herein may carry the coaptation assistance device  500  to the heart. In some embodiments, and even more distal to the implant sheath  725  is a tear away funnel  720 . The tear away funnel  720  can facilitate the folding of the coaptation assistance device  500 . In some embodiments, the most distal end of the shaft body  710  has features that may lock the shaft body  710  to the coaptation assistance device  500  so that the coaptation assistance device  500  may be transported to the heart and placed appropriately. The locking process and features are now described in relation to  FIGS. 7B ,  7 C and  7 D. 
         [0129]    Referring to  FIG. 7D , the delivery catheter  700  and the coaptation assistance device  500  can have matching features that enable them to be locked temporarily. In some embodiments, the delivery catheter  700  includes one or more distal locking tabs  705 . The coaptation assistance device  500  can include the annular hub  510  as described herein. The distal locking tabs  705  of the delivery catheter  700  may couple with features in the annular hub  510  of the coaptation assistance device  500  as will be explained herein. 
         [0130]    In some methods, the steerable catheter  600  or other guiding wires or catheters may be advanced through the ventricular projection  525  and/or anchoring mechanism  530 . In some embodiment, the anchoring mechanism  530  can have a hole or passageway in the center to allow the steerable catheter  600  to pass through, as shown in  FIG. 7D . The steerable catheter  600  can pass from the anchoring mechanism  530  to the annular hub  510 . Other paths through the coaptation assistance device  500  are contemplated. The steerable catheter  600  can pass from the anchoring mechanism  530  to the annular hub  510  and further to the delivery catheter  700 . 
         [0131]    Referring to  FIG. 7B , the tip of the delivery catheter  700  is shown in a magnified view. The annular hub  510  of coaptation assistance device  500  is also shown. Distal locking tabs  705  may be made of some shape memory material such as nitinol. The natural position of the locking tabs  705  is set such that they bend inwards and towards each other as illustrated in  FIG. 7A . In some methods, a guidewire or a catheter such as steerable catheter  600  can be inserted into the annular hub  510  and between the distal locking tabs  705 , and the distal locking tabs  705  can be pushed out against the annular hub  510 . The annular hub  510  is designed with matching pockets  740  such that the distal locking tabs  705  fit into these pockets  740 . As long as the steerable catheter  600  is present to force the distal locking tabs  705  outwards into the pockets  740 , the tip of the delivery catheter  700  remains locked to the annular hub  510 . Other locking mechanisms are possible and one such alternative is now described in  FIG. 7C . 
         [0132]    Referring to  FIG. 7C , the annular hub  510  can include a cross-pin  745 . The cross-pin  745  can be a solid piece that goes across the annular hub  510  and is held in place by methods that are known in the art. The delivery catheter  700  can include a loop of wire or suture  750 . The suture  750  which may loop around an object such as a guidewire or the steerable catheter  600  within the annular hub  510 . The suture  750  may extend into the handle  730  of the delivery catheter  700 . The handle  730  may have a mechanism which controls the tension of the suture  750 . By controlling the tension, the coaptation assistance device  500  can be pulled against and held securely to the distal end of the delivery catheter  700 . When steerable catheter  600  is retracted past the level of the cross-pin  745 , the loop  755  of the suture  750  can slip over the cross-pin  745 , thereby releasing the cross-pin  745  and the coaptation assistance device  500 . 
         [0133]    Delivery Procedure 
         [0134]      FIGS. 8A-8D  show a method of delivery. In some methods, the implant sheath  725  and the funnel  720  are advanced over the coaptation assistance device  500 . The implant sheath  725  and the funnel  720  can be advanced over the coaptation assistance device  500  after the delivery catheter  700  is locked with the coaptation assistance device  500 . The shape of the funnel  720  aids in the coaptation assistance device  500  closing or folding in on itself. The advancement of the implant sheath  725  and the funnel  720  is shown in  FIGS. 8A and 8B . The arrow  760  in  FIG. 8A  indicates how the coaptation assistance device  500  is pulled into the funnel  720 . Once the coaptation assistance device  500  is within the implant sheath  725 , the funnel  720  is removed. In some embodiments, the funnel  720  is removed by pulling on a tab  715 , thereby splitting the funnel  720 , shown in  FIG. 8C . The funnel  720  and the tab  715  can be then discarded. In some methods, the implant sheath  725  containing the coaptation assistance device  500  can be advanced over the guidewire or the steerable catheter  600 . To reiterate, the advantage of the design of the steerable catheter  600  becomes evident as the coaptation assistance device  500  can glide smoothly over the steerable catheter without having any difficulty due to different size diameters of the handle  610  and the body  605 . The implant sheath  725  can be inserted into the trans-septal sheath  650  as shown  FIG. 8D . 
         [0135]    The system of the coaptation assistance device  500  and the implant sheath  725  is advanced until it exits the trans-septal sheath  650  as shown in  FIG. 8E . The delivery catheter  700  is deflected such that the implant sheath  725  is positioned between the leaflets of the mitral valve, which is shown in  FIG. 8E . The implant sheath  725  is placed between the chordae  765  (“P2” location). Once the implant sheath  725  attains this position, the delivery catheter  700  is held in place and the implant sheath  725  is retracted slowly, causing the coaptation assistance device  500  to start exiting the implant sheath  725  as illustrated in  FIG. 8F . It is to be noted that the steerable catheter  600  or an equivalent guide wire is still in place under the posterior leaflet and can still be actively adjusted or deflected using the control handle  610 . In some methods, as the delivery catheter  700  is advanced, the coaptation assistance device  500  is pushed out, following the path of the steerable catheter  600  until the distal end  530  of the ventricular projection  525  is coupled to the ventricular tissue. This is illustrated in  FIG. 8G . While the coaptation assistance device  500  is being pushed out, the implant sheath  725  can be retracted. In some methods, rotational adjustments may be made to the delivery catheter  700  to ensure appropriate placement. 
       Anchoring 
       [0136]    Once the coaptation assistance device  500  is open, the method can include the step of anchoring the coaptation assistance device  500  on the atrial aspect of the mitral valve namely, on the on the mitral valve annulus. Several embodiments now describe the methods and systems to achieve anchoring. 
         [0137]    A support structure  505  made of a shape memory material can be advantageous. As the coaptation assistance device  500  opens, the coaptation assistance device  500  assumes the shape that was intended due to the action of the shape memory material. The shape of the coaptation assistance device  500 , as described herein, can be intended to provide a new coaptation surface so that regurgitant flows are reduced or eliminated. Returning back to the explanation of the delivery and anchoring process, the delivery catheter  700 , which can be still coupled to the annular hub  510  of the coaptation assistance device  500 , may now be manipulated (rotationally and axially) to position the coaptation assistance device  500  appropriately over the posterior leaflet of the native valve. In an embodiment, the support structure  505  of the coaptation assistance device  500  may have features which may attach to the tissue. In some embodiments, these features are passive hooks. In some methods, these features engage the annulus such that the coaptation assistance device  500  may be held in place while anchoring is commenced.  FIG. 8H  shows the state of the delivery catheter  700  with the implant sheath  725  retracted and the shaft body  710  still coupled to the annular hub  510 . 
         [0138]    An embodiment of an anchor  800  is illustrated in detail in  FIG. 8I . The anchor  800  may be coupled to the delivery catheter  700  and/or the coaptation assistance device  500  in various ways. The annular hub  510  may have a cross-pin  512 . The cross-pin  512  can provide a site about which a helical structure  815  of the anchor  800  may wrap around as shown. The anchor  800  can have a shoulder  805 . The shoulder  805  may fit around the shaft body  710  of the delivery catheter  700 . The shoulder  805  may have features such as windows  810  which can lock the distal locking tabs  705  of the delivery catheter  700 . The distal locking tabs  705  of the delivery catheter  700  can lock when a pin, guidewire or a catheter such as the steerable catheter  600  is present within the shaft body  710  of delivery catheter  700 . In some methods, the anchor  800  can be preloaded onto the coaptation assistance device  500  and locked in place with the delivery catheter  700  during the process of mounting the coaptation assistance device  500  onto the delivery catheter  700 . This can occur prior to when the coaptation assistance device  500  is pulled into the implant sheath  725  and being readied for insertion into the femoral vein. Returning back to  FIG. 8H , torque can be applied to the shaft body  710  such that the anchor  800  is driven into the tissue. To provide feedback whether the anchor  800  is secured appropriately, fluoroscopic markers may be present on the anchor  800 . The markers may be located at the proximal end. These markers may inform the medical team about how far the anchor  800  may have travelled towards the annular hub  510  and may be informative about when the anchor  800  is securely in place. In some embodiments, to ensure that appropriate torque is applied, the torque level at the handle  730  may spike as the anchor  800  bottoms out on the annular hub  510 . This increased torque level may be felt at the handle  730  providing feedback that appropriate torque has been applied. The central guidewire or the steerable catheter  600  can be retracted. This causes the distal locking tabs  705  to fall back from the windows  810  of the anchor  800 , thus unlocking the delivery catheter  700  and the anchor  800 . This can cause the releasing the coaptation assistance device  500 . The delivery catheter  700  and steerable catheter  600  may now be completely retracted. 
       Commissure Anchoring 
       [0139]    Several embodiments illustrate the commissure anchoring. One such embodiment is shown in  FIG. 9A . The delivery catheter  700  (not shown) has been retracted and an anchor catheter  900  has been advanced through the femoral access. The anchor catheter  900  is torqueable. One or more anchor catheters  900  can be provided. The distal tip of the anchor catheter  900  may have one or more features to lock the anchors in place during the delivery of the anchor. In  FIG. 9A , the distal tip has a cut-out  905  which may receive a portion of the helical anchor  915 . The anchor catheter  900  may also have central pin  920 . The central pin  920  can have a pointed end on the distal tip. In some embodiments, the central pin  920  can have the ability to be retracted. 
         [0140]      FIG. 9A  shows a loop  910 . The ends (not shown) of the loop  910  may travel to the handle of the anchor catheter  910  or some length therebetween such that the tension of the loop  910  may be controlled. The loop  910  go over a crossbar  917  or other portion which forms the proximal part of the helical anchor  915 . The top view of the helical anchor  915  with the crossbar  917  is shown in  FIG. 9B . While outside the body, prior to entry into the trans-septal sheath (not shown), the helical anchor  915  may be placed adjacent to the central pin  920 . The loop  910  may be arranged in such a manner that when tension is applied to the loop  910 , the loop  910  keeps the helical anchor  915 , and the central pin  920  locked in place. In  FIG. 9A , this arrangement is retracted so that the cutouts  905  receive the proximal portion of the helical anchor  915 . Keeping the loop  910  in tension, the entire arrangement is advanced into the trans-septal sheath. 
         [0141]    Once in the desired location within the body, the anchor catheter  900  is adjusted so that the distal end of the anchor catheter  900  is positioned over a commissure hole  520 . The central pin  920  and the helical anchor  915  are advanced such that the central pin  920  first pierces the tissue after going through a commissure hole  520 . Torque is applied to the anchor catheter  900  and the helical anchor  915  pierces the tissue. The helical anchor  915  anchors the support structure  505  or frame of the coaptation assistance device  500  to the tissue. After the helical anchor  915  is in place, the central pin  920  is retracted. The retraction of the central pin  920  can allows the loop  910  to slip over the crossbar  917  of the helical anchor  915 , thereby releasing the anchor  915 . This process can be repeated for the other commissure site to anchor both extreme projections of the coaptation assistance device  500 . 
       Alternative Anchoring Techniques 
       [0142]      FIG. 10A  shows an alternative anchoring technique in another embodiment. In this embodiment, a delivery catheter  1000  may have multiple lumens  1040 . The delivery catheter  1000  may have a cross-section as shown in  FIG. 10B . The lumens  1040  may carry individual torqueable drive shafts. Each drive shaft can be locked onto an anchor as the case is for shafts  1020  and  1030  or onto the annular hub  510  as is shown for shaft  1010 . Each torqueable shaft  1010 ,  1020 ,  1030  may have the design of the anchor catheter  900  illustrated in  FIG. 9A . The delivery catheter  1000  may have a central lumen  1050  through which a guidewire or the steerable catheter  600  may pass. The multiple torqueable drive shafts  1010 ,  1020 ,  1030 , a guidewire or the steerable catheter  600  along with the coaptation assistance device  500  can all be loaded and retracted into the implant sheath of the delivery catheter  1000  prior to entry into the trans-septal sheath. This entire arrangement can be advanced and the same procedure as explained herein can be followed to place the coaptation assistance device  500 . The advantageous aspect of this arrangement is that the anchoring process may be accomplished without the need to retract the anchor catheter multiple times, reloading the anchors and reentering the body. 
       Alternative Designs for Anchors 
       [0143]    While some anchors have been described herein, other alternative embodiments are contemplated.  FIG. 11A  shows an anchor with grappling hooks.  FIG. 11B  shows an anchor that resembles an umbrella. In both embodiments, the anchors may be made of a shape memory material. In both embodiments, the anchors may be loaded into a delivery catheter such as the delivery catheter illustrated in  FIG. 11C . 
         [0144]    Locking mechanisms such as those described herein may be used to lock the anchors to the delivery catheter. The delivery catheter may have a pointed end so that the delivery catheter may be guided to an appropriate location and initially pierce the tissue. After the delivery catheter is placed at an appropriate location and the initial piercing is accomplished, one or more of the anchors may be advanced and set in place. This step is followed by unlocking and retracting the delivery catheter. 
         [0145]      FIG. 11D  is an illustration of how the umbrella anchor of  FIG. 11B  may look after it has been set into the tissue to anchor the coaptation assistance device  500 . Due to the natural unstressed shape of the anchor, when deployed in the tissue over the coaptation assistance device  500 , the deformed shape would have an effective spring-force on the face of the coaptation assistance device  500 , ensuring a good foothold. 
       Spineless Implants 
       [0146]    The coaptation assistance device  500  described in  FIGS. 5A-F  can include the support structure  505 . The support structure  506  can be made of shape memory material as described herein. In some embodiments of the coaptation assistance device, another configuration is contemplated. This configuration can be called the spineless coaptation assistance device to indicate that the support structure is removed after placement of the coaptation assistance device in the heart. Both types of coaptation assistance devices can have certain advantages. The spineless coaptation assistance device may be advantageous due to fewer components and materials and no possible metal fatigue. 
         [0147]      FIG. 12  shows an embodiment of the spineless coaptation assistance device  1200 . The spineless coaptation assistance device  1200  can include a tube or a passageway  1210 . The passageway  1210  can be placed around the annular edge. This passageway  1210  can be called the annular tube. The spineless coaptation assistance device  1200  can include a tube or passageway  1212  along the ventricular projection. This passageway  1212  can be called the ventricular tube. 
         [0148]    The profile of the passageway  1210  can be shown towards the ends of the annular tube. Although a circular profile is illustrated, the tubes or passageways  1210 ,  1212  may have other profiles including but not limited to oval and flat. 
         [0149]    The support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  is shown by dotted lines except at the annular edges where the support structures  1210 . 1  and  1210 . 3  protrude. The support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  may have three distinct sections, where  1210 . 1  and  1210 . 3  are placed in the annular tube and  1210 . 2  is placed in the ventricular tube. The support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  can be coupled within a spine hub  1220 . In some embodiments, the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  may be distinct and separate sections. In some embodiments, the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  may be joined together by using one of various methods such as, but not limited to, crimping and laser welding. This arrangement of the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  and the coaptation assistance device  1200  allows the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  to be extracted from the coaptation assistance device  1200 . In some methods, the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  is extracted by applying a pulling force on spine hub  1220 . More detail about the coaptation assistance device  1200 , and the procedure to deliver and anchor the coaptation assistance device  1200 , will be provided herein. 
       Delivery Procedure of the Spineless Implant 
       [0150]      FIGS. 13A and 13B  illustrate the delivery procedure of the coaptation assistance device  1200 .  FIG. 13A  shows the coaptation assistance device  1200  of  FIG. 12 .  FIG. 13A  shows an additional feature, an anchor site  1300 . This anchor site  1300  will be described in greater detail herein. 
         [0151]    The steerable catheter  600  can inserted into the coaptation assistance device  1200 . The steerable catheter  600  can be inserted from the distal tip of the ventricular projection  1212 . The steerable catheter  600  can exits from an exit aperture  1335 . A delivery catheter  1320  can be provided. The delivery catheter  1320  can include a torqueable shaft  1310 . The delivery catheter  1320  can include a hub locking feature  1330  that couples with a hub anchor  1300 . In  FIG. 13A , the hub locking feature  1330  is shown as a screw. Other locking mechanisms explained herein may be utilized. 
         [0152]      FIG. 13B  illustrates more detail with regard to the delivery catheter  1320 . The distal tip of the delivery catheter  1320  can include a funnel  1360 . Proximal to the funnel  1360 , an implant introducer  1340  may be present. At the very proximal end, the delivery catheter  1320  may have a handle  1370 . 
         [0153]    The steerable catheter  600  can be threaded through the coaptation assistance device  1200  as described herein. The funnel  1360  can be inserted on to the distal tip of the delivery catheter  1320 . The coaptation assistance device  1200  can be locked in place using the locking feature  1330 , such that the hub anchor  1300  is connected to the torqueable shaft  1310 . 
         [0154]    The steerable catheter  600  can be threaded through an angled side port  1350  on the implant introducer  1340 . The coaptation assistance device  1200  and the steerable catheter  600  can be pulled through the funnel  1360  by retracting the delivery catheter  1320 . With continued retraction, the coaptation assistance device  1200  will fold upon itself within the implant introducer  1340 . Once the implant is in the introducer  1340 , the funnel  1360  is removed and discarded. The funnel  1360  may be designed such that it may be easily removed. Designs for the funnel include but are not limited to the peel away design (shown previously in  FIGS. 8A-8C ) or a clamshell design ( FIG. 13B ). 
         [0155]    The delivery catheter  1320  along with the implant introducer  1340  can be advanced over the steerable catheter  600  until the implant introducer  1340  couples with the hub of the trans-septal sheath  650 . At this point, the implant introducer  1340  may not be able to advance further but the coaptation assistance device  1200  itself can be advanced into the trans-septal sheath. The next several steps are similar to that shown in  FIGS. 8E through 8G , except in this example, no implant sheath is used. The coaptation assistance device  1200  is placed over the posterior leaflet and the ventricular projection  1212  is placed in the left ventricle. The steerable catheter  600  can be retracted allowing the ventricular projection  1212  to curl or coil under P2. Once the ventricular projection  1212  is anchored, the hub anchor  1300  can be rotated or otherwise activated. The hub anchor  1300  can anchor the proximal side of the coaptation assistance device  1200  to the annulus. The torqueable shaft  1310  can retracted. After additional anchoring, which will be explained herein, the hub locking feature  1330  is retracted pulling the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  along with it. The coaptation assistance device  1200  may now be operational in the left heart without the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3 . 
       Anchoring Procedure for Spineless Implant 
       [0156]      FIG. 14A  shows an embodiment for anchoring the coaptation assistance device  1200 . As no rigid structure such as the support structure  1210 . 1 ,  1210 . 2 ,  1210 . 3  can be present after implantation, the coaptation assistance device  1200  may need additional anchors. In some embodiments, the coaptation assistance device  1200  may utilize closely spaced anchors. In some embodiments, the coaptation assistance device  1200  may utilize additional and closely spaced anchors than a similar coaptation assistance device with a support structure  505 , described herein.  FIG. 14A  shows an embodiment of anchors  1400 , which may be used to couple the coaptation assistance device  1200  and the tissue.  FIG. 14B  shows another embodiment. In  FIG. 14B , a suture or tape  1410  is used to “sew” the coaptation assistance device  1200  to the tissue. The suture or tape  1410  may be made of one of several materials including, but not limited to, polypropylene or nylon. Several embodiments describing how the multiple anchors are placed are now explained herein. 
         [0157]      FIG. 15A  shows an embodiment of an anchor catheter  1500  that delivers multiple anchors. Several anchors  1510 , including anchor  1510 . 1  and anchor  1510 . 2 , are stacked within the anchor catheter  1500 . Although  FIG. 15A  shows two anchors  1510 . 1  and  1510 . 2  stacked within the anchor catheter  1500 , more or fewer anchors may be stacked. Each anchor  1510  may include a coil section  1550 . The coil section  1550  can include a pointed end  1570 . The anchor  1510  may include an anchor head  1560 . The anchor head  1560  may have one of several cross sections shown by  1545 . 1 ,  1545 . 2 ,  1545 . 3  and  1545 . 4  in  FIG. 15A . Other cross sections are possible. 
         [0158]    To initially load the anchor catheter  1500 , the anchors  1510  are loaded onto a central shaft  1520  of the anchor catheter  1500 . The central shaft  1520  and the anchors  1510  may have a matching cross section such that the anchors  1510  may be rotationally coupled to the central shaft  1520 . At the proximal end of the anchor catheter  1500 , a spring  1540  can be included. This spring  1540  provides a pushing force such that as the central shaft  1520  is rotated, the anchors  1510  exit the distal end of the anchor catheter  1500  in the direction of arrow  1550 . As the anchors  1510  exit, the anchor  1510  can engage with the coaptation assistance device  1200  and the tissue to couple the coaptation assistance device  1200  to the tissue. The rotation of the central shaft  1520  may be controlled by an operator such as a doctor. In some embodiments, the central shaft  1520  is coupled to a torqueable wire (not shown) which may be coupled at the proximal end to a handle (not shown). In some embodiments, the torqueable wire may be controlled manually. In some embodiments, the torqueable wire may be controlled via an electric motor. Other methods to impart a rotational motion to the central shaft  1520  are contemplated. A feature that is not shown in the  FIG. 15A  is the ability to steer and position the distal end of the anchor catheter  1500 . As one anchor  1510  is delivered, the distal tip may need to be repositioned to deliver the next anchor  1510 . A steering mechanism such as pull wires may be included to steer the distal tip of the anchor catheter  1500 . 
         [0159]      FIG. 15B  shows another embodiment of an anchor catheter  1600  that delivers multiple anchors.  FIG. 15B  shows only the distal tip of an anchor catheter  1600 . The anchor catheter  1600  can include multiple anchors  1610  such as  1610 . 1  and  1610 . 2 . Although the anchor catheter  1600  shows five anchors, more or fewer anchors  1610  may be loaded at any one time. The anchor catheter  1600  may have a central shaft  1630 . The anchor catheter  1600  can include threads such as  1620  on the inside of the housing  1605 . These threads  1620  can house the coils of the anchors  1610  as shown. To initially load the anchor catheter  1600 , the anchors  1610  are inserted into the housing  1605 . The anchors  1610  are inserted onto the central shaft  1630 . As described previously, the cross-section of the central shaft  1630  may match the cross-section of the anchors  1610  so that the anchors  1610  may be mounted on the central shaft  1630 . The rotation of the central shaft  1630  may be controlled by a torqueable cable (not shown) which may couple the central shaft  1630  to a handle (not shown) of the anchor catheter  1600 . The operator such as a doctor may control the rotation. In some embodiments, the torqueable wire may be controlled manually. 
         [0160]    In some embodiments, the torqueable wire may be controlled via an electric motor. As the central shaft  1630  rotates, the threads will force the anchors  1610  to exit the anchor catheter  1600  and engage with the coaptation assistance device  1200  and the tissue to couple the coaptation assistance device  1200  and the tissue together. The anchor catheter  1600  may also have pull wires to steer the distal tip of the anchor catheter  1600  so that as one anchor  1610  is delivered, the anchor catheter  1600  may be positioned to deliver the next anchor  1610 . 
         [0161]      FIG. 15B  illustrates a central suture  1635 . The central suture  1635  can include a ball  1640  coupled to the end of the central suture  1635 .  FIGS. 15C and 15D  illustrate how the central suture  1635  and ball  1640  may be used. The ball  1640  can sit in a pocket inside the first anchor  1610 . 1 . The central suture  1635  can connect the first anchor  1610 . 1  to the second anchor  1610 . 2  and others anchors  1610  (not shown in the figure). This arrangement may provide the ability to use the central suture  1635  as a guide wire to return back to an anchor  1610  after the anchor  1610  has been screwed into the tissue  1645 . The operator may wish to return to the anchor  1610  to reposition or adjust the anchor  1610 . In addition, if one or more anchors  1610  came loose, the central suture  1635  may provide a tether for the loose anchors  1610 , therefore preventing embolic events. 
         [0162]      FIG. 16A-C  shows another embodiment of an anchor catheter  1700  that delivers multiple anchors. The anchor catheter  1700  can have a hollow shaft. The hollow shaft can be pointed at the distal end which may be used to pierce the coaptation assistance device  1200  and tissue. Multiple anchors  1710  such as  1710 . 1 ,  1710 . 2  may be arranged within the hollow shaft of the anchor catheter  1700 . The anchors  1710  can be hollow barrels. 
         [0163]    A suture  1720  may be threaded through the anchors  1710  as shown. The suture  1720  may be secured to the first anchor  1710 . 1  by arranging the suture  1720  to exit the second anchor  1710 . 2  and enter the first anchor  1710 . 1  through a side aperture  1740 . The suture  1720  may then be secured by means of a knot as depicted in dotted lines within the first anchor  1710 . 1 . The suture  1720  in the other anchors  1710 , except the first anchor  1710 . 1 , may appear as illustrated for the anchor  1710 . 2 . The anchors  1710 , except the first anchor  1710 . 1  have a portion of their walls cut out. The cut outs can aids in better trapping the anchors within the tissue, similar to a toggle-bolt. At the proximal end of the anchor catheter  1700 , a feature such as a pusher tube  1750  may be present to cause the anchors  1710  such as  1710 . 1  and  1710 . 2  to exit the anchor catheter  1700  at the distal end. The pusher  1750  may be attached to a handle (not shown) so as to enable an operator such as a doctor to deposit one or more anchors  1710  when appropriate. The arrow  1760  indicates the direction of the push. 
         [0164]      FIG. 16B-C  illustrates how the anchor catheter  1700  of  FIG. 16A  may operate. In  FIG. 16B , the anchor catheter  1700  is advanced through the coaptation assistance device  1200  through a slot such as described by  520  in  FIG. 5A . The anchor catheter  1700  then pierces the tissue  1645 . The operator pushes the first anchor  1710 . 1  out of the anchor catheter  1700 , depositing the anchor  1710 . 1  within the tissue. Once the first anchor  1710 . 1  is deposited, the rest of the anchors  1710  are deposited as illustrated in  FIG. 16C . In  FIG. 16C , the anchor catheter  1700  is pulled out of the tissue after depositing the first anchor  1710 . 1  in order to enter a second location. At the second location, the anchor catheter  1700  can deposit the second anchor  1710 . 2 . This process is continued until desired to secure the coaptation assistance device  1200  to the tissue. After the last anchor  1710  is delivered, a cutter (not shown) can be advanced inside the anchor catheter  1700  to cut the suture  1720 , leaving behind the anchors  1710 . 
         [0165]    In some embodiments, the anchors  1710  may be radio opaque or they may be covered by a radio graphic marker. During the process of delivery of the anchors  1710 , the radio opaque markers may be visualized if a fluoroscope is used. This may help in spacing the anchors  1710  around the annulus of the coaptation assistance device  1200 . 
         [0166]    In some embodiments, the MR is assessed while securing the coaptation assistance device  1200  and the pitch and/or the location of the sewing action is determined according to the presence or absence of the MR. 
         [0000]    Spineless Implant with Annular Tube 
         [0167]      FIG. 17A  illustrates another embodiment of a spineless coaptation assistance device  1800 . In this embodiment, the support structure  1810  may only traverse down the ventricular projection  1820 . A tube or passageway  1830  may be present around the annular edge of the coaptation assistance device  1800 . Instead of utilizing a support structure  1810  to maintain the shape of the coaptation assistance device  1800 , an anchor catheter  1850  can be inserted into the tube  1830  as shown in  FIG. 17B . In  FIG. 17B , the anchor catheter  1850  can be a deflectable anchor catheter. 
         [0168]      FIG. 17B  also shows a first site  1860 . 1  where an anchor such as that described by  1560  in  FIG. 15A  can be delivered. At this site  1860 . 1  and all anchor sites  1860 , the tip of the anchor catheter  1850  would be deflected by controls located outside the body. The anchors (not shown) may be delivered securing the coaptation assistance device  1800  to the tissue. The tip of the anchor catheter  1850  may be radio opaque which may then be visualized during the anchor delivery process. The visualization of the tip may be utilized to locate the anchors around the annulus of the coaptation assistance device  1800 .  FIG. 17B  illustrates a first anchor location  1860 . 1  and  FIG. 17C  illustrates a second anchor location  1860 . 2 . After the appropriate number of anchors are delivered, the anchor catheter  1850  is retracted completely as shown in  FIG. 17D . Finally the support structure  1810  can be removed as shown in  FIG. 17E . 
         [0169]    In a variation of the embodiment shown in  FIGS. 17A-17E , the support structure  1810  may not be limited only to the ventricular projection; it may also be inserted through the annular tube  1830  such that a desired shape may be maintained. The support structure can be a shape memory material. Utilizing a support structure around the annular tube  1830  may result in an anchor catheter which may have relatively simpler control mechanisms compared to the anchor catheter  1850  used for the coaptation assistance device  1800  described in  FIG. 17A . 
         [0170]    It is contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments disclosed above may be made and still fall within one or more of the inventions. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above. Moreover, while the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “inserting a coaptation assist body proximate the mitral valve” includes “instructing the inserting of a coaptation assist body proximate the mitral valve.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers, and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.

Technology Classification (CPC): 0