Patent Description:
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.

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.

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.

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.

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.

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.

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).

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.

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'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.

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.

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.

Prior art document <CIT> discloses in figures 10A-10E a coaptation element.

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.

The invention relates to an implant for treating mal-coaptation of a heart valve and is defined by the appended claims. In some embodiments, the implants comprise a coaptation assist body which remains within the blood flow path as the valve moves back and forth between an open-valve configuration and a closed valve configuration. The coaptation assist body may extend laterally across some, most, or all of the width of the valve opening, allowing coaptation between at least one of the native leaflets and the implant body. In some embodiments, also disclosed is an implant, which can be a cardiac implant, such as a coaptation assist body, cardiac patch, replacement heart valve, annuloplasty ring, pacemaker, sensor, or other device. At least one ribbon (e.g., clip) can be configured to extend from the implant body. The ribbon can be made of a shape memory material having a preformed shape with at least one curve. The ribbon is movable from a first compressed configuration to a second expanded configuration. The ribbon is configured to provide a force, such as a compressive force to clip to a body structure, such as an intracardiac structure. In some embodiments, the intracardiac structure is a single native valve leaflet, and the force is applied between a first surface of the ribbon and a second surface of the ribbon opposed from the first surface of the ribbon. The compressive force can be sufficient to secure the implant in the vicinity of the native valve annulus.

In some embodiments, an implant for treating mal-coaptation of a heart valve is provided. The heart valve can have an annulus and first and second leaflets with an open configuration and a closed configuration. The implant can include a coaptation assist body having a first coaptation surface configured to be disposed to the posterior leaflet, an opposed second surface configured to be disposed toward the anterior leaflet. The implant can include at least one ribbon configured to extend from the coaptation assist body. The ribbon can comprise a shape memory material having a preformed shape with at least one, two, or more discrete curves. The ribbon is movable from a first compressed configuration to a second expanded configuration. The ribbon can be configured to provide a compressive force on a native valve leaflet between a first surface and a second surface opposed from the first surface of the ribbon. The compressive force can be sufficient to secure the implant, such as the coaptation assist body, in the vicinity of the native valve annulus. The ribbon can be configured to provide ventricular attachment of the implant. The ribbon can comprise a nitinol alloy. The ribbon can be self-expanding. The implant can include a plurality of ribbons. The ribbon can be configured to engage the left ventricle wall. The ribbon can be configured to engage the anterior or the posterior leaflet. The ribbons resists movement of the implant. The implant can include at least one eyelet configured to accept a portion of an anchor there through. The implant can include a clip and pledget configured to secure the anchor to the coaptation assist body.

In some embodiments, an implant for treating mal-coaptation of a heart valve is provided. The heart valve can have an annulus and first and second leaflets with an open configuration and a closed configuration. The implant can include a coaptation assist body having a first coaptation surface configured to be disposed to the posterior leaflet, an opposed second surface configured to be disposed toward the anterior leaflet. The implant can include a first anchor selectively deployable at a first target location. The implant can include a first rail coupled to the first anchor. The implant can include a second anchor selectively deployable, independently of the deployment of the first anchor, at a second location of the heart. The implant can include a second rail coupled to the second anchor. The coaptation assist body can be configured to slide along the first rail and the second rail to the implantation site. The coaptation assist body can be configured to slide along the first rail and the second rail when collapsed to fit within a delivery catheter. The coaptation assist body can be configured to slide along the first rail and the second rail when expanded upon exiting a delivery catheter. The first rail can be a suture. The second rail can be a suture. The ventricular anchor can be unfolded and held in relation to the coaptation assist body when the coaptation assist body slides along the first rail and the second rail. The ventricular anchor can traverse the mitral valve when the coaptation assist body slides along the first rail and the second rail. The implant can include a clip and pledget configured to secure the first anchor to the coaptation assist body. The implant can include a clip and pledget configured to secure the second anchor to the coaptation assist body. The first rail can be configured to be removed once first anchor is secured to the coaptation assist body. The second rail can be configured to be removed once second anchor is secured to the coaptation assist body.

In some embodiments, an implant for treating mal-coaptation of a heart valve, comprises a coaptation assist body having a first coaptation surface, an opposed second surface, each surface bounded by a first lateral edge; a first anchor selectively deployable at a first target location of the heart near the second leaflet on the annulus and coupleable to the coaptation assist body near the superior edge; a second anchor selectively deployable, independently of the deployment of the first anchor, at a second location of the heart in the ventricle such that the coaptation assist body, when coupled to both the first anchor and the second anchor, extends from the first target location across the valve to the second target location; and wherein the second anchor is a ventricular anchor capable of engaging a wall of the left ventricle.

In various implementations, a method for treating mal-coaptation of a heart valve in a patient, the heart valve having an annulus and first and second leaflets, the first and second leaflets each comprising a proximal surface, a distal surface, a coaptation edge and an annular edge; the annulus further defining a valve plane, the valve plane separating an atrium proximally and a ventricle distally, the method comprises: selectively deploying a first anchor into heart tissue near anterior and posterior fibrous trigones; selectively deploying a second anchor near the left ventricle wall; coupling the first anchor and the second anchor to a coaptation assist body comprising a coaptation surface and a leaflet surface such that the coaptation assist body is suspended across the valve plane from the atrium proximally to the ventricle distally.

Disclosed herein are improved medical devices, systems, and methods, often for treatment of mitral valve regurgitation and other valve diseases including tricuspid regurgitation. While the description that follows includes reference to the anterior leaflet in a valve with two leaflets such as the mitral valve, it is understand that "anterior leaflet" could refer to one or more leaflets in a valve with multiple leaflets. For example, the aortic valve or tricuspid valve typically has <NUM> leaflets so the "anterior" could refer to one or two of the medial, lateral, and posterior leaflets. The implants described herein will generally include a coaptation assist body (sometimes referred to herein as a valve body) which is generally along the blood flow path as the leaflets of the valve move back and forth between an open-valve configuration (with the anterior leaflet separated from valve body) and a closed-valve configuration (with the anterior leaflet engaging opposed surfaces of the valve body). The valve body will be disposed between the native leaflets to close the gap caused by mal-coaptation of the native leaflets by providing a surface for at least one of the native leaflets to coapt against, while effectively replacing second native leaflet in the area of the valve which it would occlude during systole, were it functioning normally. The gaps may be lateral (such as may be caused by a dilated left ventricle and/or mitral valve annulus) and/or axial (such as where one leaflet prolapses or is pushed by fluid pressure beyond the annulus when the valve should close).

Among other uses, the coaptation assistance devices, implants, and methods described herein may be configured for treating functional and/or degenerative mitral valve regurgitation (MR) by creating an artificial coaptation zone within which at least one of the native mitral valve leaflets can seal. The structures and methods herein will largely be tailored to this application, though alternative embodiments might be configured for use in other valves of the heart and/or body, including the tricuspid valve, valves of the peripheral vasculature, the inferior vena cava, or the like.

Referring to <FIG>, the four chambers of the heart are shown, the left atrium <NUM>, right atrium <NUM>, left ventricle <NUM>, and right ventricle <NUM>. The mitral valve <NUM> is disposed between the left atrium <NUM> and left ventricle <NUM>. Also shown are the tricuspid valve <NUM> which separates the right atrium <NUM> and right ventricle <NUM>, the aortic valve <NUM>, and the pulmonary valve <NUM>. The mitral valve <NUM> is composed of two leaflets, the anterior leaflet <NUM> and posterior leaflet <NUM>. In a healthy heart, the edges of the two leaflets oppose during systole at the coaptation zone <NUM>.

The fibrous annulus <NUM>, part of the cardiac skeleton, provides attachment for the two leaflets <NUM>, <NUM> of the mitral valve <NUM>, referred to as the anterior leaflet <NUM> and the posterior leaflet <NUM>. The leaflets <NUM>, <NUM> are axially supported by attachment to the chordae tendinae <NUM>. The chordae <NUM>, in turn, attach to one or both of the papillary muscles <NUM>, <NUM> of the left ventricle <NUM>. In a healthy heart, the chordae <NUM> support structures tether the mitral valve leaflets <NUM>, <NUM>, allowing the leaflets <NUM>, <NUM> 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 <NUM>, <NUM> helps promote an effective seal or coaptation. The leading edges of the anterior and posterior leaflet come together along a funnel-shaped zone of coaptation <NUM>, with a lateral cross-section <NUM> of the three-dimensional coaptation zone (CZ) being shown schematically in <FIG>.

The anterior and posterior mitral leaflets <NUM>, <NUM> are dissimilarly shaped. The anterior leaflet <NUM> is more firmly attached to the annulus overlying the central fibrous body (cardiac skeleton), and is somewhat stiffer than the posterior leaflet <NUM>, which is attached to the more mobile posterior mitral annulus. Approximately <NUM> percent of the closing area is the anterior leaflet <NUM>. Adjacent to the commissures <NUM>, <NUM>, on or anterior to the annulus <NUM>, lie the left (lateral) <NUM> and right (septal) <NUM> fibrous trigones which are formed where the mitral annulus is fused with the base of the non-coronary cusp of the aorta (<FIG>). The fibrous trigones <NUM>, <NUM> form the septal and lateral extents of the central fibrous body <NUM>. The fibrous trigones <NUM>, <NUM> 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 <NUM> between the leaflets <NUM>, <NUM> is not a simple line, but rather a curved funnel-shaped surface interface. The first <NUM> (lateral or left) and second <NUM> (septal or right) commissures are where the anterior leaflet <NUM> meets the posterior leaflet <NUM> at the annulus <NUM>. As seen most clearly in the axial views from the atrium of <FIG>, and <FIG>, an axial cross-section of the coaptation zone <NUM> 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 leaflet <NUM> versus the anterior leaflet <NUM>. 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 <NUM>.

Referring now to <FIG>, a properly functioning mitral valve <NUM> of a heart is open during diastole to allow blood to flow along a flow path FP from the left atrium <NUM> toward the left ventricle <NUM> and thereby fill the left ventricle <NUM>. As shown in <FIG>, the functioning mitral valve <NUM> closes and effectively seals the left ventricle <NUM> from the left atrium <NUM> during systole, first passively then actively by increase in ventricular pressure, thereby allowing contraction of the heart tissue surrounding the left ventricle <NUM> to advance blood throughout the vasculature.

Referring to <FIG> and <FIG>, there are several conditions or disease states in which the leaflet edges of the mitral valve <NUM> fail to oppose sufficiently and thereby allow blood to regurgitate in systole from the left ventricle <NUM> into the left atrium <NUM>. 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.

Generally, mal-coaptation can result from either excessive tethering by the support structures of one or both leaflets <NUM>, <NUM>, 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 <NUM> becoming stretched, known as mitral valve prolapse, and in some cases tearing of the chordae <NUM> or papillary muscle <NUM>, known as a flail leaflet <NUM>, as shown in <FIG>. Or if the leaflet tissue itself is redundant, the valves may prolapse so that the level of coaptation occurs higher into the left atrium <NUM>, opening the valve <NUM> higher in the left atrium <NUM> during ventricular systole <NUM>. Either one of the leaflets <NUM>, <NUM> can undergo prolapse or become flail. This condition is sometimes known as degenerative mitral valve regurgitation.

In excessive tethering, as shown in <FIG>, the leaflets <NUM>, <NUM> of a normally structured valve may not function properly because of enlargement of or shape change in the valve annulus <NUM>: so-called annular dilation <NUM>. 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.

<FIG> illustrate the backflow BF of blood during systole in functional mitral valve regurgitation (<FIG>) and degenerative mitral valve regurgitation (<FIG>). The increased size of the annulus <NUM> in <FIG>, coupled with increased tethering due to hypertrophy of the left ventricle <NUM> and papillary muscles <NUM>, <NUM>, prevents the anterior leaflet <NUM> and posterior leaflet <NUM> from opposing, thereby preventing coaptation. In <FIG>, the tearing of the chordae <NUM> causes prolapse of the posterior leaflet <NUM> upward into the left atrium <NUM>, which prevents opposition against the anterior leaflet <NUM>. In either situation, the result is backflow of blood into the left atrium <NUM>, which decreases the effectiveness of left ventricle compression.

<FIG> show four views of an embodiment of a coaptation assistance device <NUM> which comprises a body <NUM>. The body <NUM> comprises a first surface <NUM> disposed toward a mal-coapting native leaflet, in the instance of a mitral valve <NUM>, the posterior leaflet <NUM> and a second surface <NUM> which may be disposed toward the anterior leaflet <NUM>. The first and second surfaces <NUM>, <NUM> can be considered a coaptation surface. The superior edge <NUM> of the body <NUM> may be curved to match the general shape of the annulus <NUM> or adjoining atrial wall. The coaptation assistance device <NUM> can comprise a frame <NUM> configured to provide structural support to the coaptation assistance device <NUM>. In some embodiments, the frame <NUM> is collapsible to fit within a delivery catheter, as described herein.

The coaptation assistance device <NUM> may include one or a plurality of anchors to stabilize the device, such as atrial anchors and/or ventricular anchors, with the anchors optionally providing redundant fixation. As shown in <FIG>, the implant has lateral commissural anchors <NUM> which may help maintain the shape and position of the coaptation assistance device <NUM> once deployed in the heart. In some embodiments, the lateral commissural anchors <NUM> are placed under the leaflets <NUM>, <NUM> at the site of commissures <NUM>, <NUM>. The coaptation assistance device <NUM> can also have a posterior anchor <NUM>. In some embodiments, the posterior anchor <NUM> engages the area under the posterior leaflet <NUM>. As shown in <FIG>, the commissural anchors <NUM> and the posterior anchors <NUM> can each comprise ribbons <NUM> that have a bias such that they can exert a force, and rest against the tissue of the heart, such as the ventricle. The ribbons <NUM> function as anchors and resist movement of the coaptation assistance device <NUM>, and can do so without penetrating the myocardium in some embodiments. The positioning of the ribbons <NUM> against features of the anatomy may provide stability of the coaptation assistance device <NUM>. The ribbons <NUM> may comprise bio-inert materials such as, for example, Platinum/Ir, a Nitinol alloy, and/or stainless steel. In some embodiments, the ribbons <NUM> comprise NiTi. In some embodiments, the ribbons <NUM> have a pre-determined curve. The material selection combined with the selected shape provides anchors <NUM>, <NUM> that are spring loaded. The ribbons <NUM> extend in a direction, such as downward, from the frame <NUM>. The ribbons <NUM> curve and then extend upward, forming a generally U-shaped configuration. The ribbons <NUM> comprise a rounded top surface configured to abut tissue. As disclosed herein, the coaptation assistance device <NUM> is collapsed inside the delivery catheter <NUM> as shown in <FIG>. The spring loaded ribbons <NUM> are capable of being collapsed within the delivery catheter. Upon exiting the catheter, the spring loaded ribbons <NUM> rapidly expand into the preformed shape. In some embodiments, the ribbons <NUM> are provided for ventricular attachment. The ribbons <NUM> allow for very rapid attachment of the coaptation assistance device <NUM> to the tissue, since the ribbons <NUM> do not rely on annular sutures and do not require tying knots in some embodiments. The deployment of the ribbons <NUM> can be faster than engaging a helical anchor, for instance.

In some embodiments, the coaptation assistance device <NUM> includes an annular anchor <NUM>. The annular anchor <NUM> can be, in some embodiments, a radially expandable stent-like structure, as shown in <FIG>. Like the commissural anchors <NUM>, the annular anchor <NUM> can be collapsed to fit inside a catheter, described herein. In some embodiments, the annular anchor <NUM> can be delivered to the site of the mitral valve <NUM>. In some embodiments, the annular anchor <NUM> is intended for placement in the mitral annulus <NUM>. The annular anchor <NUM> may include a plurality of barbs for acute fixation to the surrounding tissue. In some embodiments, the annular anchor <NUM> may be simply held in place via radial forces. The annular anchor <NUM>, if it is included, may be covered with biocompatible materials such as ePTFE or Dacron to promote endothelialization and, optionally, chronic tissue in-growth or encapsulation of the annular anchor for additional stability.

In other embodiments, the atrial anchors may comprise a plurality of helixes, clips, harpoon or barb-shaped anchors, or the like, appropriate for screwing or engaging into the annulus <NUM> of the mitral valve <NUM>, tissues of the ventricle <NUM>, other tissues of the atrium <NUM>, or other tissue. The body <NUM> can include one or more features such as eyelets or tethers to couple with the atrial anchors.

The coaptation assistance device <NUM> has a geometry which permits it to traverse the mitral valve <NUM> between attachment sites in the left atrium <NUM> and left ventricle <NUM>, to provide a coaptation surface <NUM> for the anterior leaflet <NUM> to coapt against, and attach to the left atrium <NUM> or annulus <NUM> such that it effectively seals off the posterior leaflet <NUM>. In the instance that the posterior leaflet <NUM> is or has been removed, the coaptation assistance device <NUM> replaces the posterior leaflet <NUM>.

Different sized coaptation assistance device <NUM>, particularly the different sized bodies <NUM>, can be placed such that the native anterior leaflet <NUM> opposes the coaptation surface <NUM> at the appropriately established coaptation point, blocking flow of blood during contraction of the left ventricle <NUM>. In order to accomplish this, a variety of sizes of coaptation assistance device <NUM> are provided, with differing dimensions configured to fit varying anatomies. As seen in the top view of <FIG>, there is a dimension A which is an inter-commissural distance. This distance may be, for example, within a range of about <NUM> to about <NUM>, and in one embodiment about <NUM>. There is a dimension B which is an anterior-posterior diameter. This diameter may be, for example, within a range of about <NUM> to about <NUM>, and in one embodiment about <NUM>. There is a dimension C which is the anterior-posterior projection. This dimension may be within a range of, e.g., about <NUM> to about <NUM> depending on the mitral valve regurgitation (MR). For degenerative MR, this dimension may be, e.g., within a range of about <NUM> to about <NUM>. For functional MR, this dimension may be, e.g., within a range of about <NUM> to about <NUM>. As shown in <FIG>, there is a dimension D which is the coaptation assistance device <NUM> height. This dimension may be, e.g., within a range of about <NUM> to about <NUM>, and in one embodiment about <NUM>.

Turning now to <FIG>, an embodiment of the coaptation assistance device <NUM> is shown. It can be seen that in some embodiments, the coaptation assistance device <NUM> is collapsed inside the delivery catheter <NUM>. The stent-like structure of the frame <NUM> of the coaptation assistance device <NUM> including the structure of the annular anchor <NUM> and commissural anchors <NUM> allows the coaptation assistance device <NUM> to be collapsed.

In the embodiment shown in <FIG>, a number of struts <NUM> may couple to the coaptation assistance device <NUM>. The struts <NUM> may connect to the coaptation assistance device <NUM> at any number of locations, e.g., superior edge <NUM>, annular anchor <NUM>, commissural anchors <NUM>, to a ventricular hub described herein. The struts <NUM> couple the coaptation assistance device <NUM> to the catheter <NUM> and/or implant introducer <NUM>. Each strut <NUM> may comprise a single longitudinal element or be doubled over to comprise two or more strands. A single strut <NUM> may be comprised of a strand of Nitinol wire, suture, or other material which loops toward the superior aspect of the implant. This loop area may provide reinforcement around an interruption in the covering material. In some embodiments, the struts <NUM> could include clips, jaws, adhesive, or another mechanism to form a releasable attachment between the struts <NUM> and the coaptation assistance device <NUM>. The struts <NUM> may be, as shown, placed such that they are relatively evenly spaced, or may be concentrated toward the center or lateral edges of the coaptation assistance device <NUM>. The struts <NUM> may be coupleable with the anchors <NUM>, <NUM>, <NUM> which may be deployed into various locations including the mitral annulus <NUM>, left atrium <NUM>, left auricle, one of the fibrous trigones <NUM>, or the left ventricle <NUM>.

As shown in <FIG>, the body <NUM> of the coaptation assistance device <NUM> can be delivered by a delivery catheter <NUM> and may be capable of expanding from a smaller profile to a larger profile to dimensions appropriate for placement in between the valve's native leaflets <NUM>, <NUM>. The coaptation assistance device <NUM> is expanded as it is exposed from the tip of the delivery catheter <NUM>. In some embodiments, the delivery catheter <NUM> is pulled back to expose the coaptation assistance device <NUM> as shown by the arrow in <FIG>. The exposed coaptation assistance device <NUM> is detached from the delivery catheter <NUM> as shown in <FIG>, for instance by releasing the struts <NUM>.

Turning now toward implantation, a coaptation assistance device <NUM> may be implanted through a minimally invasive or transcatheter technique utilizing a delivery system <NUM>. The coaptation assistance device <NUM> can be substantially similar to the coaptation assistance device <NUM> described herein. The delivery system <NUM> can include one or more of the following devices: a transseptal sheath <NUM> shown in <FIG>, an anchor delivery catheter <NUM> shown in <FIG>, an implant delivery catheter <NUM> shown in <FIG>, and a clip delivery catheter <NUM> shown in <FIG>. As illustrated in <FIG>, the delivery system <NUM> may include a transseptal sheath <NUM> having a shaft <NUM> that may be made of a polymeric or other material. In some embodiments, the shaft <NUM> is a braid or coil reinforced polymer shaft. In some embodiments, the shaft <NUM> has multiple durometers, such as a first smaller durometer at a first location and a second larger durometer at a second location distal or proximal to the first location. In some embodiments, the transseptal sheath <NUM> is pre-shaped. The shaft <NUM> can include at least one through lumen (e.g., two, or more through lumens). In some embodiments, the transseptal sheath <NUM> comprises an actively deflectable tip <NUM> to facilitate navigation into the left ventricle <NUM>. The deflectable tip <NUM> can be controlled by various mechanisms, for instance via pullwires operably attached to the deflectable tip <NUM> and connected to a proximal control.

The transseptal sheath <NUM> may include a seal <NUM> to accommodate various instruments and guidewires inserted therein. The seal can accommodate diameters including the outer diameter of the anchor delivery catheter <NUM>, the implant delivery catheter <NUM>, and the clip delivery catheter <NUM>. In some embodiments, the accommodated diameters can be up to <NUM> Fr. Fr, where <NUM> Fr=<NUM>,<NUM>. The transseptal sheath <NUM> may include lined inner diameter <NUM>. The lined inner diameter <NUM> may be within a range of about <NUM> to about <NUM> Fr, and in one embodiment preferably <NUM> Fr. The transseptal sheath <NUM> has sufficient length over a section <NUM> to span from the access point (e.g., outside the body) to the tip of the left ventricle <NUM>. The access point may be via groin/femoral access. This length may be, e.g., within a range of about <NUM> to about <NUM>, and in one embodiment about <NUM>. The transseptal sheath <NUM> may include atraumatic tip <NUM>. The tip <NUM> may include a marker band <NUM> for visualization. The transseptal sheath <NUM> may include flush port <NUM> operably connected to the central lumen of shaft <NUM> at a proximal hub <NUM> as illustrated. The system may further include additional ports, including flush, irrigation and/or aspiration ports to remove fluid or air from the system and allow injection of fluids such as saline or contrast media to the site of implantation.

Referring now to <FIG>, aspects of the anchor delivery catheter <NUM> are illustrated. <FIG> shows an embodiment of the anchor delivery catheter <NUM>. The anchor delivery catheter <NUM> may include a shaft <NUM> made of a material such as a polymer. In some embodiments, the shaft <NUM> is a braid or coil reinforced polymer shaft. In some embodiments, the shaft <NUM> has multiple durometers, such as a first smaller durometer at a first location and a second larger durometer at a second location distal or proximal to the first location. The anchor delivery catheter <NUM> has sufficient length over a section <NUM> to span from the access point (e.g., outside the body) and through the transseptal sheath <NUM>. This length may be, e.g., within a range of about <NUM> to about <NUM>, and in one embodiment about <NUM>. In other embodiments, the anchor delivery catheter <NUM> comprises an actively deflectable tip <NUM> to facilitate navigation of the anchors to the anchoring sites. The anchor delivery catheter <NUM> is configured to deploy an anchor <NUM>.

The anchor delivery catheter <NUM> may include a drive shaft <NUM>. The drive shaft <NUM> is configured to couple with a drive continuation <NUM> to allow transmission of torque to the anchor <NUM>. In some embodiments, the drive shaft <NUM> is flexible. In some embodiments, the drive shaft <NUM> is capable of being advanced or retracted. The anchor delivery catheter <NUM> may include a handle <NUM>. The handle <NUM> may include a knob <NUM> to enable simple manipulation of the torque or position of the anchor <NUM>. The knob is internally connected to the drive shaft <NUM> thereby allowing transmission of torque to the anchor <NUM> when the knob <NUM> is rotated.

The anchor <NUM> has an outer diameter which may be within a range of about <NUM> to about <NUM>, and in one embodiment preferably <NUM>. The anchor <NUM> may be helical with a pitch within a range of about <NUM> to about <NUM>, and in one embodiment preferably <NUM>. The anchor <NUM> in some embodiments has a wire diameter which may be within a range of about <NUM> to about <NUM>, and in one embodiment preferably <NUM>. The anchor <NUM> may be coupled to the drive continuation <NUM>. As shown, the drive continuation <NUM> can be a square continuation of the anchor helix. However, the drive continuation <NUM> may be of any shape, such as triangular or hexagonal, capable of transmitting the torque imparted by the drive shaft <NUM>. The anchor <NUM> can include anchor suture <NUM>. The anchor delivery catheter <NUM> may include one or more rails <NUM> (e.g., sutures, guidewires) attached to the proximal end of anchor <NUM> and/or the anchor suture <NUM>. For the anchor <NUM> shown in <FIG>, such as the trigonal anchor, the rails <NUM> (e.g., sutures, guidewires) facilitate subsequent proper placement of the coaptation assistance device <NUM>. For some method, the rails <NUM> are cut after anchor placement.

Referring now to <FIG>, aspects of the implant delivery catheter <NUM> are illustrated. The implant delivery catheter <NUM> can be inserted into the transseptal sheath <NUM> shown. The seal <NUM> is sized to accommodate the implant delivery catheter <NUM>. The transseptal sheath <NUM> allows the introduction of the implant delivery catheter <NUM> through a lumen of the shaft <NUM> and into the left atrium <NUM>. The transseptal sheath <NUM> may include a variable stiffness outer shaft <NUM> with at least one lumen, the lumen sized to allow insertion of the implant delivery catheter <NUM> and/or coaptation assistance device <NUM> through the lumen. The deflectable tip <NUM> and/or a deflectable portion of the shaft <NUM> may facilitate alignment of the coaptation assistance device <NUM> with the valve leaflets <NUM>, <NUM>.

The implant delivery catheter <NUM> comprises a shaft <NUM>. The shaft <NUM> can be a variable stiffness shaft, with the stiffness varying along a dimension, for instance along the length. The shaft <NUM> can include at least one through lumen (e.g., two, or more through lumens). The shaft <NUM> can be include a deflectable tip <NUM> configured for deflecting along at least a distal section. The deflectable tip <NUM> can be controlled by various mechanisms, for instance via pullwires operably attached to the deflectable tip <NUM> and connected to a proximal control.

The delivery catheter may further include an implant introducer <NUM>. The implant introducer <NUM> can be sized to pass through the shaft <NUM> of the implant delivery catheter <NUM>. The implant introducer <NUM> can include a slot <NUM>. The implant delivery catheter <NUM> may further include a handle <NUM> to manipulate the implant delivery catheter <NUM> within the transseptal sheath <NUM> and/or body of the patient. The handle <NUM> may include a knob <NUM> to enable simple manipulation of the position of the coaptation assistance device <NUM>. The knob <NUM> is internally connected to the implant introducer <NUM> thereby allowing transmission of movement to the implant introducer <NUM> when the knob <NUM> is manipulated. In some embodiments, the knob <NUM> can manipulate the docking and undocking of the coaptation assistance device <NUM> with the implant delivery catheter <NUM>. The handle <NUM> may further include one or more ports <NUM>, such as a flush, irrigation and/or aspiration port to remove the air from the system and allow injection of fluids such as saline or contrast media to the site of implantation.

As shown in <FIG>, the coaptation assistance device <NUM> is inserted into the implant delivery catheter <NUM>. The coaptation assistance device <NUM> is shown in the top view of <FIG>. In some embodiments, the coaptation assistance device <NUM> is unfolded in the direction of the arrows as shown in the middle view of <FIG>. The coaptation assistance device <NUM> can be coupled to the implant introducer <NUM>. In some embodiments, a portion of the coaptation assistance device <NUM> is held within the slot <NUM>. In some embodiments, a portion of the coaptation assistance device <NUM> folds around the deflectable tip <NUM> of the implant delivery catheter <NUM> in the direction of the arrows shown in the bottom view of <FIG>. The coaptation assistance device <NUM> can be coupled to the implant introducer <NUM> and the deflectable tip <NUM> of the implant delivery catheter <NUM>. As shown in <FIG>, the attached coaptation assistance device <NUM> can slide along (e.g., engage) one or more rails <NUM> (e.g., two rails <NUM>), which may be rails <NUM> coupled to anchor <NUM>. The rails <NUM> can extend through transseptal sheath <NUM> from the anchor <NUM> to the coaptation assistance device <NUM>. The coaptation assistance device <NUM> can advance over two rails as shown in <FIG>. In some embodiments, the rails <NUM> extend through eyelets or other apertures of the coaptation assistance device <NUM>. The rails <NUM> can extend through (e.g., be pulled through) the implant delivery catheter <NUM>. The rails <NUM> can help guide the coaptation assistance device <NUM> toward the implantation site and/or toward the anchor <NUM>. The rails <NUM> in some embodiments are flexible guidewires and/or sutures. In some embodiments, the rails <NUM> are pulled in the direction of the arrows to advance the coaptation assistance device <NUM> and/or implant delivery catheter <NUM> through the transseptal sheath <NUM> In some embodiments, systems that include a plurality of rails <NUM>, such as two rails <NUM> for example advantageously allows for more controlled and symmetric deployment of the coaptation assistance device.

Referring now to <FIG>, aspects of the clip delivery catheter <NUM> are illustrated. The clip delivery catheter <NUM> comprises a shaft <NUM>. The shaft <NUM> can be a variable stiffness shaft, with the stiffness varying along a dimension, for instance along the length. The shaft <NUM> may include a polymer shaft. In some embodiments, the shaft <NUM> is a braid or coil reinforced polymer shaft. In some embodiments, the shaft <NUM> has multiple durometers. The shaft <NUM> can include at least one through lumen (e.g., two, or more through lumens). In some embodiments, the shaft <NUM> comprises an actively deflectable tip <NUM> to facilitate navigation of various clips <NUM> and/or pledgets <NUM> to the anchoring sites. The clips <NUM> and pledgets <NUM> may be comprised of any suitable material, such as suture, flexible material, Nitinol, metal, or plastic. In one embodiment, the preferred material is Nitinol. The deflectable tip <NUM> can be configured for deflecting along at least a distal section. The deflectable tip <NUM> can be controlled by various mechanisms, for instance via pullwires operably attached to the deflectable tip <NUM> and connected to a proximal control.

The clip delivery catheter <NUM> has sufficient length to fully pass through the transseptal sheath <NUM> with additional length provided for tip deflection. This distance may be within a range of, e.g., about <NUM> to about <NUM>, and in one embodiment about <NUM>. The delivery catheter may further include a hypotube <NUM>. The implant hypotube 196can be sized to pass through the shaft <NUM> of the clip delivery catheter <NUM>. The clip delivery catheter <NUM> may further include a handle <NUM> to manipulate the clip delivery catheter <NUM> within the transseptal sheath <NUM> and/or body of the patient to steer the hypotube <NUM> of the clip delivery catheter. The handle <NUM> may also deploy the clip <NUM> and/or pledget <NUM> to the intended site. The handle <NUM> may further include one or more ports <NUM>, such as a flush, irrigation and/or aspiration port to remove the air from the system and allow injection of fluids such as saline or contrast media to the site of implantation.

The hypotube <NUM> or other elongate member extends through the clip <NUM> and/or the pledget <NUM>. In some embodiments, the clip <NUM> and/or the pledget <NUM> are initially loaded on the hypotube <NUM>, as shown. In some embodiments, a second hypotube <NUM> coaxial with and having a larger diameter than the hypotube <NUM> is used to push the clip <NUM> and/or the pledget <NUM> from the hypotube <NUM>. In some embodiments, the deflectable tip <NUM> having a larger diameter than the hypotube <NUM> is used to push the clip <NUM> and/or the pledget <NUM> from the hypotube <NUM>. Other mechanism can be used to push the clip <NUM> and/or the pledget <NUM> (e.g., pusher wire, jaws).

The clip delivery catheter <NUM> may include pledget <NUM>. The pledget <NUM> may be of generally circular shape as shown, or may be square or rectangular, elliptical, or any other desired form. The pledget <NUM> may be comprised of any one of a number of suitable materials known to those of skill in the art. In some instances it may be advantageous to use a material which promotes tissue ingrowth, enhancing the connection of the coaptation assist device <NUM> to the patient's tissue. In other embodiments, a material which inhibits or is inert with respect to tissue ingrowth may be preferred, such as ePTFE, VTFE, PTFE (poly tetrafluoroethylene), Teflon, polypropylene, polyester, polyethylene terephthalate, or any suitable material. In some embodiments, a coating may be placed on the pledget <NUM> to inhibit or encourage tissue ingrowth. One or more anchors <NUM> may penetrate the material of the pledget <NUM> at a suitable position, securing the pledget <NUM> to underlying cardiac tissue. Thus, in some embodiments, the pledget <NUM> may comprise an easily punctured material, such as structural mesh, felt, or webbing.

The clip delivery catheter <NUM> may include clip <NUM>. In one embodiment, the clip <NUM> is made from twisted strands of a metal or alloy, e.g., NiTi <NUM>-<NUM> to form a cable. In some embodiments, eight strands are twisted to form clip <NUM>. In one embodiment, the strand diameters are within a range of about <NUM>,<NUM> to about <NUM>,<NUM> (<NUM> to about <NUM> inches, inches) and in one embodiment about <NUM> (<NUM> inches).

Referring now to <FIG>, the implantation steps of one implementation of the method is shown. As shown in <FIG>, a transseptal method for treatment of MR will often include gaining access to the left atrium <NUM> via a transseptal sheath <NUM>. Access to the femoral vein may be obtained, for example, using the Seldinger technique. From the femoral vein, access can then be obtained via the right atrium <NUM> to the left atrium <NUM> by a transseptal procedure. A variety of conventional transseptal access techniques and structures may be employed, so that the various imaging, guidewire advancement, septal penetration, and contrast injection or other positioning verification steps need not be detailed herein.

Transseptal sheaths, such as the transseptal sheath <NUM> and/or other transseptal sheaths, can have an elongate outer sheath body of the shaft <NUM> extending between a proximal handle <NUM> to a distal end, with the handle <NUM> having an actuator (not shown) for steering a distal segment and/or deflectable tip <NUM> of the shaft <NUM> similar to that described above. A distal electrode and/or marker <NUM> near the distal end of sheath body can help position the sheath within the left atrium. In some embodiments, an appropriately sized deflectable transseptal sheath <NUM> without steering capability may be guided into position in the left atrium <NUM> by a steerable transseptal sheath <NUM> or may be advanced into the left atrium <NUM> without use of a steerable transseptal sheath <NUM>. Alternatively, deployment may proceed through a lumen of the steerable sheath. Regardless, in some embodiments an outer access sheath will preferably be positioned so as to provide access to the left atrium LA via a sheath lumen.

Referring now to <FIG>, the anchor delivery catheter <NUM> may be advanced through the outer transseptal sheath <NUM> and into the left atrium <NUM>. The distal end and/or the deflectable tip <NUM> of the anchor delivery catheter <NUM> moves within the left atrium <NUM> by manipulating the proximal handle <NUM> and by articulating the actuator of the handle (not shown) so as to selectively bend the distal end and/or the deflectable tip <NUM> of the anchor delivery catheter <NUM>, bringing the distal end of the anchor delivery catheter <NUM> into alignment and/or engagement with candidate locations for deployment of an anchor <NUM>. The anchor delivery catheter <NUM> can be aligned optionally under guidance of 2D or 3D intracardiac, transthoracic, and/or transesophageal ultrasound imaging, Doppler flow characteristics, fluoroscopic or X-ray imaging, or another imaging modality.

In some embodiments, an electrode (not shown) at the distal end of the anchor delivery catheter <NUM> optionally senses electrogram signals and transmits them to an electrogram system EG so as to help determine if the candidate site is suitable, such as by determining that the electrogram signals include a mix of atrial and ventricular components within a desired range (such as within an acceptable threshold of <NUM>:<NUM>). Contrast agent or saline may be introduced through the anchor delivery catheter <NUM>.

As shown in <FIG>, the anchor <NUM>, for instance a first trigonal anchor, is delivered and engaged with the implantation site. Another anchor, for instance a second trigonal anchor is delivered and engaged with another implantation site. The locations of the anchors <NUM> are shown in relationship to the anterior leaflet <NUM> and the posterior leaflet <NUM> as shown in the smaller snapshot. As shown in <FIG>, in some embodiments, each anchor <NUM> comprises at least one rail <NUM> (e.g., suture, guidewire) such that the coaptation assistance device <NUM> can be advance over the rail <NUM>. The coaptation assistance device <NUM> is advanced over one or more rails <NUM> (e.g., two rails) as shown by the arrows in <FIG>. In this way, the rails <NUM> facilitate placement of the coaptation assistance device <NUM>. The coaptation assistance device <NUM> is advanced over the posterior leaflet <NUM>, as shown.

As shown in <FIG>, the coaptation assistance device <NUM> is extended through the mitral valve <NUM> into the left ventricle <NUM>. In some embodiments, the coaptation assistance device <NUM> may have a ventricular anchor <NUM> (e.g., ribbon such as the ribbons described herein or other ventricular anchor) that is expanded and engaged to attach the coaptation assistance device <NUM>. After placement of the coaptation assistance device <NUM> the coaptation assistance device <NUM> can be locked on the anchors <NUM> (such as trigonal anchors) by one or more clips <NUM> and/or one or more pledgets <NUM>, as shown in <FIG>. After the coaptation assistance device <NUM> is deployed and/or locked on the anchors <NUM>, the delivery system <NUM> is removed, as shown in <FIG>.

The aforementioned method can be performed by a physician. In one embodiment, a manufacturer can provides one, some or all of the following: coaptation assistance devices, for instance coaptation assistance device <NUM>, transseptal sheath <NUM>, anchor delivery catheter <NUM>, implant delivery catheter <NUM>, and clip delivery catheter <NUM>. In some embodiments, the manufacturer provides a kit containing some or all of the devices previously described.

In some embodiments, the manufacturer provides instructions for use of the system including one or more of the following steps, or any step previously described in the drawings. The steps may include: gaining access to the left atrium <NUM> via the transseptal sheath <NUM>; gaining access to the femoral vein via the Seldinger technique; gaining access via the right atrium <NUM> to the left atrium <NUM> by a transseptal procedure, utilizing a variety of conventional transseptal access techniques and structures. The steps may include: positioning the transseptal sheath <NUM> within the left atrium <NUM>; deploying the anchor delivery catheter <NUM> through the transseptal sheath <NUM> and into the left atrium <NUM>; bringing the distal end of the anchor delivery catheter <NUM> into alignment and/or engagement with candidate locations for deployment of the anchor <NUM>; and determining if the candidate site is suitable. The steps may include: delivering and/or engaging the anchor <NUM>, which may be the first trigonal anchor; deploying the rail <NUM> attached to the anchor <NUM>; advancing the coaptation assistance device <NUM> over the rail <NUM>; delivering and/or engaging the second anchor <NUM>, which may be a second trigonal anchor; deploying the rail <NUM> attached to the second anchor; advancing the coaptation assistance device <NUM> over the rail <NUM> of the first anchor <NUM> and the rail <NUM> of the second anchor <NUM>; facilitating placement of the coaptation assistance device <NUM> with the rails <NUM>; and positioning the coaptation assistance device <NUM> over the posterior leaflet <NUM>. The steps may include: extending the coaptation assistance device <NUM> through the mitral valve <NUM> into the left ventricle <NUM>; expanding a ventricular anchor <NUM> of the coaptation assistance device <NUM>; locking the coaptation assistance device <NUM> on the one or more anchors <NUM> by the clip <NUM> and/or the pledget <NUM>; and removing the delivery system <NUM>. These instructions can be written, oral, or implied.

Referring now to <FIG>, the method of clip <NUM> and pledget <NUM> placement is shown. As shown in <FIG>, in some embodiments the clip <NUM> and pledget <NUM> are initially loaded on the hypotube <NUM>. A guide suture <NUM> extends in a loop from the hypotube <NUM>. The guide suture <NUM> can engage the anchor suture <NUM>. The anchor suture <NUM> is connected to the anchor <NUM> as shown in <FIG>. The hypotube <NUM> is retracted into the clip delivery catheter <NUM>, as shown by the upward arrow in <FIG>. The distal tip of the clip delivery catheter <NUM> pushes downward on the clip <NUM>, as shown by the downward arrow in <FIG>. The clip <NUM> presses against the pledget <NUM> and both the clip <NUM> and the pledget <NUM> are pressed downward by the clip delivery catheter <NUM>. The clip <NUM> and the pledget <NUM> are advanced along the anchor suture <NUM>. The compression force of the clip <NUM> on the anchor suture <NUM> locks the clip <NUM> on the anchor suture <NUM>. The pledget <NUM> is prevented from translation along the anchor suture <NUM> by the locking of the clip <NUM>. In some embodiments, the second hypotube <NUM> is pressed downward on the clip <NUM> and the pledget <NUM> instead of, or in addition to, the tip of the clip delivery catheter <NUM>.

As shown in <FIG>, the guide suture <NUM> can extend from the hypotube <NUM>. In some embodiments, the hypotube <NUM> is crimped over the guide suture <NUM>. This crimping allows easy introduction of the clip <NUM> and/or the pledget <NUM> over the guide suture <NUM>. This crimping also ensures a proper connection between the hypotube <NUM> and the anchor <NUM>. After the clip <NUM> and/or the pledget <NUM> is locked, the guide suture <NUM> can be cut and retracted through the clip delivery catheter <NUM>, as shown in <FIG>.

The aforementioned method can be performed by a physician. In one implementation, a manufacturer can provide one, some or all of the following: the clip <NUM>, the pledget <NUM>, the hypotube <NUM>, the second hypotube <NUM>, the anchor <NUM>, the anchor suture <NUM>, the guide suture <NUM>, and clip delivery catheter <NUM>. In some embodiments, the manufacture provides a kit containing some or all of the devices previously described.

In some embodiments, the manufacturer provides instructions for use of the system including one or more of the following steps, or any step previously described or inherent in the drawings. The steps may include: initially loading the clip <NUM> and/or the pledget <NUM> on the hypotube <NUM>; extending the guide suture <NUM> from the hypotube <NUM>; engaging the guide suture <NUM> to the anchor suture <NUM>; connecting the anchor suture <NUM> to the anchor <NUM>; retracting the hypotube <NUM> into the clip delivery catheter <NUM>; pressing the distal tip of the clip delivery catheter <NUM> downward on the clip <NUM>; pressing the clip <NUM> against the pledget <NUM>; pressing both the clip <NUM> and the pledget <NUM> downward; and advancing the clip <NUM> and the pledget <NUM> along the anchor suture <NUM>. The steps may include: crimping the hypotube <NUM> over the guide suture <NUM>; cutting the guide suture <NUM> after the clip <NUM> is locked; and retracting the guide suture <NUM> through the clip delivery catheter <NUM>. These instructions can be written, oral, or implied.

Turning now to <FIG>, an embodiment of the coaptation assistance device <NUM> is shown. The coaptation assistance device <NUM> can be substantially similar to the coaptation assistance device <NUM>, <NUM> described herein. The coaptation assistance device <NUM> can include frame <NUM> configured to provide structural support to the coaptation assistance device <NUM>. In some embodiments, the frame <NUM> is collapsible to fit within a delivery catheter, as described herein. In some embodiments, the frame <NUM> defines a superior edge <NUM>. The frame <NUM> can include anchor eyelets <NUM> configured to accept an anchor, such as anchor <NUM> or other trigonal anchors. The eyelets <NUM> can be integrated into the surface of the coaptation assistance device <NUM> or coupled to the coaptation assistance device <NUM> by any mechanism known in the art. The eyelets <NUM> correspond to the region of the coaptation assistance device <NUM> that may be secured to the anterior and posterior fibrous trigones <NUM>, <NUM>. In general, the trigones <NUM>, <NUM> are located approximately <NUM>-<NUM> lateral or medial to their respective commissures <NUM>, <NUM>, and about <NUM>-<NUM> more anterior than the commissures <NUM>, <NUM>. In other embodiments, different anchor arrangements may connect the superior edge <NUM> of the coaptation assistance device <NUM> can to an anchor, such as anchor <NUM>. For instance, the superior edge <NUM> can include a hub (not shown) for an anchor to extent or a tether (not shown) connecting the anchor or a hub to the superior edge <NUM>. In some embodiments, the medial end of a tether or the hub is connected to the eyelet <NUM>.

Alternate engagement means are contemplated for connecting the coaptation assistance device <NUM> to each anchor, including the eyelets <NUM> and hubs (not shown), but also including other connection means such as, for example, sutures, staples, adhesive or clips. In alternative embodiments, the anchors may form an integrated part of the device. In some embodiments, both anchors inserted within the eyelet <NUM> are helical anchors. There are many possible configurations for anchoring means, compositions of anchors, and designs for anchoring means.

The coaptation assistance device <NUM> comprises a body <NUM>. The body <NUM> comprises a first surface <NUM> disposed toward a mal-coapting native leaflet, in the instance of a mitral valve <NUM>, the posterior leaflet <NUM> and a second surface <NUM> which may be disposed toward the anterior leaflet <NUM>. The first and second surfaces <NUM>, <NUM> can be considered cooptation surface. The coaptation assistance device <NUM> can have a geometry which permits it to traverse the mitral valve <NUM> between attachment sites in the left atrium <NUM> and/or the left ventricle <NUM>, to provide a coaptation surface <NUM> for the anterior leaflet <NUM> to coapt against, and attach to the left atrium <NUM> or annulus <NUM> such that it effectively seals off the posterior leaflet <NUM>. In the instance that the posterior leaflet <NUM> is or has been removed, the coaptation assistance device <NUM> replaces the posterior leaflet <NUM>.

In some embodiments, the coaptation surface <NUM>, <NUM> of the coaptation assistance device <NUM> passes superiorly and radially inwardly from the superior edge <NUM>, before passing distally, in a longitudinal direction perpendicular to the valve plane, or radially inwardly or outwardly with respect to the valve plane.

In some embodiments, the first surface <NUM> and the second surface <NUM> of the coaptation assistance device <NUM> further comprise a covering comprised of ePTFE, polyurethane foam, polycarbonate foam, biologic tissue such as porcine pericardium, or silicone.

One possible frame <NUM> structure is shown, with frame <NUM> connecting the eyelets <NUM>. Other frame elements may be incorporated into the coaptation assistance device <NUM>. The frame <NUM> may be shaped in any number of ways to assist in maintaining the desired shape and curvature of the coaptation assistance device <NUM>. The frame <NUM> can be made of Nitinol, stainless steel, polymer, or other appropriate materials, and can substantially assist in maintain the geometry of the coaptation assistance device <NUM>, permitting choice of any of a wide variety of covering materials best suited for long term implantation in the heart and for coaptation against the anterior leaflet <NUM>.

The coaptation assistance device <NUM> may include one or a plurality of anchors, such as anchor <NUM>, to stabilize the coaptation assistance device <NUM>. The coaptation assistance device <NUM> can also have a ventricular anchor <NUM> (e.g., ribbons described herein). In some embodiments, the ventricular anchor <NUM> engages the area under the posterior leaflet <NUM>. the atrial and/or ventricular anchors optionally providing redundant fixation. The anchors may include a plurality of barbs for acute fixation to the surrounding tissue. In other embodiments, the anchors may comprise a plurality of helixes, clips, harpoon or barb-shaped anchors, or the like, appropriate for screwing or engaging the annulus <NUM> of the mitral valve <NUM>, tissues of the ventricle, and/or other tissues of the atrium, or the atrial or ventricular anchors may attach to the tissue by welding using RF or other energy delivered via the elongate anchor coupling body.

In some embodiments, a ventricular anchor <NUM> may be included in the form of a tether or other attachment means extending from the valve <NUM> thru the ventricle septum to the right ventricle <NUM>, or through the apex into the epicardium or pericardium, which may be secured from outside the heart in and combined endo/epi procedure. When helical anchors are used, they may comprise bio-inert materials such as Platinum/Ir, a Nitinol alloy, and/or stainless steel.

Referring now to <FIG>, the implantation steps of one implementation of the method is shown. As shown in <FIG>, a transseptal method for treatment of MR can include gaining access to the left atrium <NUM> via the transseptal sheath <NUM>. Access to the femoral vein may be obtained using the Seldinger technique. From the femoral vein, access can then be obtained via the right atrium <NUM> to the left atrium <NUM> by a transseptal procedure. A variety of conventional transseptal access techniques and structures may be employed, so that the various imaging, guidewire advancement, septal penetration, and contrast injection or other positioning verification steps need not be detailed herein.

Referring now to <FIG>, non-limiting candidate locations are illustrated for deployment of an anchor, such as anchor <NUM>, optionally under guidance of 2D or 3D intracardiac, transthoracic, and/or transesophageal ultrasound imaging, Doppler flow characteristics, fluoroscopic or X-ray imaging, or another imaging modality. In some embodiments, a guidewire is used to advance the anchors <NUM> to the desired location. In some embodiment, a posteromedial trigonal anchor <NUM> is placed and an anterolateral trigonal anchor <NUM> is placed using the guidewire.

As shown in <FIG>, the first and second trigonal anchors <NUM> are delivered and engaged. The locations of the trigonal anchors <NUM> are shown in relationship to the anterior leaflet <NUM>, the posterior leaflet <NUM>, and mitral valve <NUM> as shown. In some embodiments, each trigonal anchor <NUM> comprises at least one guidewire or rail <NUM> such that the coaptation assistance device <NUM> can be advanced over the rails <NUM>. In some embodiments, the rails <NUM> advance through a portion of the coaptation assistance device <NUM> and through the transseptal catheter <NUM>. In some embodiments, the rails <NUM> extend through eyelets <NUM>.

It can be seen that in some embodiments, the coaptation assistance device <NUM> is collapsed inside the anchor delivery catheter <NUM>. The radially expandable and/or collapsible structure including frame <NUM>, which can be stent-like in some embodiments, allows the implant to be collapsed. In some embodiments, the coaptation assistance device <NUM> is collapsed and delivered through the transseptal catheter <NUM> over the rails <NUM>.

As shown, after two trigonal anchors <NUM> are delivered and received; the coaptation assistance device <NUM> is advanced over two rails <NUM> as shown by the arrows in <FIG>. In this way, the rails <NUM> facilitate placement of the coaptation assistance device <NUM>. As the coaptation assistance device <NUM> is delivered over the rails <NUM>, the coaptation assistance device <NUM> exits the implant delivery catheter <NUM>, allowing the coaptation assistance device <NUM> to be exposed and expanded.

The coaptation assistance device <NUM> can be delivered by the implant delivery catheter <NUM> and may be capable of expanding from a smaller profile to a larger profile to dimensions appropriate for placement in between the valve's native leaflets <NUM>, <NUM>. The coaptation assistance device <NUM> is expanded as it is exposed from the tip of the implant delivery catheter <NUM> as shown. In some embodiments, the implant delivery catheter <NUM> is pulled back to expose the coaptation assistance device <NUM>. The coaptation assistance device <NUM> is advanced over the posterior leaflet <NUM>.

As shown in <FIG>, the coaptation assistance device <NUM> can extend through the mitral valve <NUM> into the left ventricle <NUM>. In some embodiments, the coaptation assistance device <NUM> may have a ventricular anchor <NUM> that is expanded to attach the coaptation assistance device <NUM> to ventricular tissue. The ventricular anchor <NUM> of the coaptation assistance device <NUM> can be delivered by the implant delivery catheter <NUM>. A shown in <FIG>, the implant delivery catheter <NUM> is retracted into the transseptal catheter <NUM>. The ventricular anchor <NUM> of the coaptation assistance device <NUM> is released and can assume a curved shape as shown. After placement of the coaptation assistance device <NUM>, in some embodiments, the coaptation assistance device <NUM> is locked on the anchors <NUM> by one or more clips <NUM> and/or pledget <NUM>, as shown in <FIG>. After the coaptation assistance device <NUM> is locked on the anchors <NUM>, the catheter delivery system <NUM> is removed. In some embodiments, the rails <NUM> are also removed.

The aforementioned method can be performed by a physician. In one embodiment, a manufacturer can provide one, some or all of the following: coaptation assistance device <NUM>, transseptal sheath <NUM>, anchor delivery catheter <NUM>, implant delivery catheter <NUM>, and clip delivery catheter <NUM>. In some embodiments, the manufacturer provides a kit containing some or all of the devices previously described.

In some embodiments, the manufacturer provides instructions for use of the system including one or more of the following steps, or any step previously described or inherent in the drawings. The steps may include: gaining access to the left atrium <NUM> via a transseptal sheath <NUM>; gaining access to the femoral vein via the Seldinger technique; gaining access via the right atrium <NUM> to the left atrium <NUM> by a transseptal procedure, utilizing a variety of conventional transseptal access techniques and structures. The steps may include: positioning the transseptal sheath <NUM> within the left atrium <NUM>; deploying an anchor delivery catheter <NUM> through the transseptal sheath <NUM> and into the left atrium <NUM>; bringing the distal end of the anchor delivery catheter <NUM> into alignment and/or engagement with candidate locations for deployment of an anchor <NUM>; and determining if the candidate site is suitable. The steps may include: collapsing the coaptation assistance device <NUM> inside the implant delivery catheter <NUM>; delivering the coaptation assistance device <NUM> through the transseptal sheath <NUM> over the rails <NUM>; expanding the coaptation assistance device <NUM> as it exits the implant delivery catheter <NUM>; and retracting the implant delivery catheter <NUM>. The steps may include: delivering and/or engaging the anchor <NUM>, which may be the first trigonal anchor; deploying a raid <NUM> attached to each anchor <NUM>; advancing the coaptation assistance device <NUM> over the rail <NUM>; delivering and/or engaging the second anchor <NUM>, which may be the second trigonal anchor; deploying the rail <NUM> attached to the second anchor; advancing the coaptation assistance device <NUM> over the rails <NUM> delivering and/or engaging the second anchor <NUM>; facilitating placement of the coaptation assistance device <NUM>; and positioning the coaptation assistance device <NUM> over the posterior leaflet <NUM>. The steps may include: extending the coaptation assistance device <NUM> through the mitral valve <NUM> into the left ventricle <NUM>; expanding a ventricular anchor <NUM> of the coaptation assistance device <NUM>; locking the coaptation assistance device <NUM> on the anchors <NUM> by one or more clips <NUM> and/or pledgets <NUM>; and removing the catheter delivery system <NUM>. These instructions can be written, oral, or implied.

Turning now to <FIG>, an embodiment of the coaptation assistance device <NUM> is shown. The coaptation assistance device <NUM> can be substantially similar to the coaptation assistance device <NUM>, <NUM>, <NUM> described herein. The coaptation assistance device <NUM> can include frame <NUM> configured to provide structural support to the coaptation assistance device <NUM>. In some embodiments, the frame <NUM> is collapsible to fit within a delivery catheter, such as implant delivery catheter <NUM>. In some embodiments, the frame <NUM> defines a superior edge <NUM>. The frame <NUM> can include anchor eyelets <NUM> configured to accept an anchor, such as anchor <NUM>. In some embodiments, such as shown in <FIG>, the eyelets <NUM> are configured to accept a commissure anchor <NUM>. Commissure anchor locations are provided, such as at lateral ends of an arcuate body portion of the coaptation assistance device <NUM> as shown. In some embodiments, the commissure anchor <NUM> is substantially similar or identical to the anchor <NUM> described herein. The eyelets <NUM> can be integrated into the surface of the coaptation assistance device <NUM> or coupled to the coaptation assistance device <NUM> by any mechanism known in the art. The eyelets <NUM> correspond to the region of the coaptation assistance device <NUM> that may be secured to the lateral commissures <NUM>, <NUM>. In other embodiments, different anchor arrangements may connect the frame <NUM> of the coaptation assistance device <NUM> to anchors. In other embodiments, different anchor arrangements may connect the frame <NUM> and/or edge of the coaptation assistance device <NUM> to the corresponding anatomic structure. In some embodiments, one or more of the commissure anchors <NUM> are helical anchors, as shown. There are many possible configurations for anchoring, compositions of anchors, and designs as, for example, previously described.

The coaptation assistance device <NUM> comprises a body <NUM>, which may be configured to permit relatively normal circulation of blood in the ventricular chamber. The body <NUM> may be elongate and narrow between the anterior and posterior surfaces, taking up minimal space and allowing movement of blood from one side to another and past both lateral aspects of the coaptation assistance device <NUM>.

The coaptation assistance device <NUM> may include one or a plurality of ventricular anchors <NUM>. The atrial anchors and ventricular anchors can optionally provide redundant fixation. The atrial anchors may include a plurality of barbs for acute fixation to the surrounding tissue. In other embodiments, the atrial anchors may comprise a plurality of helixes, clips, harpoon or barb-shaped anchors, or the like, appropriate for engaging tissues of the ventricle. As shown in <FIG>, the ventricular anchor can comprise two ribbons <NUM> that rest against the wall of the left ventricle <NUM>. While two ribbons <NUM> are shown, in some embodiments one or more ribbons <NUM> are used (e.g.,. one, two, three, four etc.). This position may provide stability of the coaptation assistance device <NUM> and/or the base <NUM> of the coaptation assistance device <NUM>. When ventricular anchors <NUM> are used, they may comprise bio-inert materials such as, for example, Platinum/Ir, a Nitinol alloy, and/or stainless steel. In some embodiments, the ribbons <NUM> comprise NiTi. In some embodiments, the ribbons <NUM> have a pre-determined curve. The material selection combined with the selected shape provides a ventricular anchor <NUM> that is spring loaded. In some embodiments, the spring loaded ribbons <NUM> engage tissues of the left ventricle <NUM> as shown. Each ribbon <NUM> can form, for example, a generally U-shaped configuration. The ribbons <NUM> function as anchors and resist movement of the coaptation assistance device <NUM>. The ribbons <NUM> together can form a generally W-shaped configuration. The ribbons <NUM> comprise a rounded surface configured to abut tissue. In some embodiments, the anchors abut tissue and can exert a force on the tissue to stabilize the coaptation assistance device <NUM>, but do not penetrate through one or more tissue layers, e.g., the endocardium or myocardium. In some embodiments, the anchors include a pair of arms with a bias that when in an unstressed configuration can clip onto a portion of the ventricular wall to stabilize the coaptation assistance device, such as in a non-traumatic manner with respect to the ventricular wall. The size and shape of the ribbons can be determined based upon the dimensions of the left ventricle <NUM>, and the left ventricle wall which the ribbons <NUM> may abut. The ribbons <NUM> can be generally parallel to the base of the posterior leaflet <NUM>. Other shapes for the ribbons <NUM> are contemplated. As disclosed herein, the coaptation assistance device <NUM> is collapsed inside the delivery catheter, such as implant delivery catheter <NUM>. The spring loaded ribbons <NUM> are capable of being collapsed within the delivery catheter. Upon exiting the catheter, the spring loaded ribbons <NUM> rapidly expand into the preformed shape. In some embodiments, the ribbons <NUM> are provided for ventricular attachment. The ribbons <NUM> allow for very rapid attachment of the coaptation assistance device <NUM> to the tissue, since the ribbons <NUM> do not rely on annular sutures and do not require tying knots. The deployment of the ribbons <NUM> can be faster than engaging a helical anchor, for instance.

Turning now to <FIG>, an embodiment of the coaptation assistance device <NUM> is shown. The coaptation assistance device <NUM> can be substantially similar to the coaptation assistance device <NUM>, <NUM>, <NUM>, <NUM> described herein. The coaptation assistance device <NUM> can include frame <NUM> configured to provide structural support to the coaptation assistance device <NUM>. In some embodiments, the frame <NUM> is collapsible to fit within a delivery catheter, such as implant delivery catheter <NUM>. In some embodiments, the frame <NUM> defines a superior edge <NUM>. The frame <NUM> can include anchor eyelets <NUM> configured to accept an anchor, such as anchor <NUM>. In some embodiments, such as shown in <FIG>, the eyelets <NUM> are configured to accept an anchor <NUM>. A plurality of locations for eyelets <NUM> are provided as shown in <FIG>. In other embodiments, different anchor arrangements may connect the edge of the coaptation assistance device <NUM> to the corresponding anatomic structure. In some embodiments, the anchors <NUM> are helical anchors, as shown. There are many possible configurations for anchoring means, compositions of anchors, and designs for anchoring means. In some embodiments, the anchor <NUM> can be substantially similar or identical to anchor <NUM>.

The coaptation assistance device <NUM> may include one or a plurality of atrial anchors <NUM> and ventricular anchors <NUM>, with the anchors optionally providing redundant fixation. In some embodiments, the atrial anchors <NUM> may comprise a plurality of helixes, clips, harpoon or barb-shaped anchors, or the like, appropriate for engaging tissues of the ventricle. The atrial anchors <NUM> may extend through the posterior leaflet as shown. As shown in <FIG>, the ventricular anchor <NUM> comprises a plurality of, e.g., three spring-loaded clips or ribbons <NUM> configured to engage at least a portion of a mitral valve <NUM>, e.g., a portion of posterior leaflet <NUM> resides in between the ribbons <NUM> and the body <NUM>. A clip or ribbon can has a bias (e.g., by virtue of its shape memory properties) such that one, two, or more surfaces exert a force, such as a compressive force, on a body structure such as a valve leaflet as shown sufficient to anchor the implant in place. For example, a first portion of a clip can apply a force against a first surface of a valve leaflet as illustrated, and a second portion of the clip can apply a force or rest against a second side of the leaflet, the second side of the leaflet opposite the first side of the leaflet. While three ribbons <NUM> are shown, in some embodiments any number of ribbons <NUM> can be used (e.g., one, two, three, four, etc.). This position may provide stability of the coaptation assistance device <NUM> and/or the implant base <NUM>. This position may not require additional anchoring of the coaptation assistance device to the ventricle <NUM> or elsewhere. When ribbons <NUM> are used, they may comprise, e.g., bio-inert materials such as Platinum/Ir, a Nitinol alloy, and/or stainless steel. In some embodiments, the ribbons <NUM> comprise NiTi. In some embodiments, the ribbons <NUM> have a pre-determined curve. The material selection combined with the selected shape provides a ventricular anchor <NUM> that is spring loaded. The ribbons <NUM> rest against the posterior leaflet, as shown. In some embodiments, the spring loaded ribbons <NUM> engage other tissues of the mitral valve. Each ribbon <NUM> can form a generally S-shaped configuration. The ribbons <NUM> function as anchors and resist movement of the coaptation assistance device <NUM>. The ribbons <NUM> comprise a rounded surface configured to abut tissue. The size and shape of the ribbons <NUM> can be determined based upon the dimensions of the posterior leaflet <NUM> which the ribbons <NUM> may abut. The ribbons <NUM> can be generally parallel to the tip of the posterior leaflets <NUM>. Other shapes for the ribbons <NUM> are contemplated. As disclosed herein, the coaptation assistance device <NUM> is collapsed inside the delivery catheter. The spring loaded ribbons <NUM> are capable of being collapsed within the delivery catheter, such as implant delivery catheter <NUM>. Upon exiting the catheter, the spring loaded ribbons <NUM> rapidly expand into the preformed shape. In some embodiments, the ribbons <NUM> are provided for ventricular attachment. The ribbons <NUM> allow for very rapid attachment of the coaptation assistance device <NUM> to the tissue, since the ribbons <NUM> do not rely on annular sutures and do not require tying knots. The deployment of the ribbons <NUM> can be faster than engaging a helical anchor, for instance.

In an alternative embodiment, the ribbons <NUM> are provided. The ribbons <NUM> extend to the base of the posterior leaflet <NUM> and align with the anchor <NUM>. The anchor <NUM> positioned on the posterior leaflet <NUM> may penetrate the leaflet <NUM> and connect with the ribbon <NUM>. Alternatively, anchors <NUM> positioned on the ribbons <NUM> may penetrate the posterior leaflet from the opposite direction. In some embodiments, the anchor <NUM> can engage the upper, left atrium side of the coaptation assistance device <NUM> and the ribbons <NUM> located in the left ventricle. This configuration may improve the stability of the coaptation assistance device <NUM>. Each ribbon <NUM> can form a generally L-shaped configuration. The ribbons <NUM> comprise a rounded surface configured to abut the ventricular side of the posterior leaflet <NUM>. The size and shape of the ribbons can be determined based upon the dimensions of the posterior leaflet <NUM> which the ribbons <NUM> may abut. The ribbons <NUM> can be generally parallel to the tip of the posterior leaflet <NUM>. Other shapes for the ribbons <NUM> are contemplated. As disclosed herein, the coaptation assistance device <NUM> is collapsed inside the delivery catheter. The spring loaded ribbons <NUM> are capable of being collapsed within the delivery catheter, such as implant delivery catheter <NUM>. Upon exiting the catheter, the spring loaded ribbons <NUM> rapidly transform from a first compressed configuration into the preformed shape of the second expanded configuration. In some embodiments, the clips or ribbons <NUM> are linear or substantially linear in a compressed configuration. In some embodiments, the ribbons <NUM> are provided for ventricular attachment. The ribbons <NUM> allow for very rapid attachment of the coaptation assistance device <NUM> to the tissue, since the ribbons <NUM> do not rely on annular sutures and do not require tying knots. The deployment of the ribbons <NUM> can be faster in some cases than engaging a helical anchor, for instance.

In some embodiments, the clips or ribbons as disclosed in connection with various embodiments herein can be advantageously utilized with a wide variety of cardiac implants not limited to the coaptation assistance devices disclosed herein. For example, the clips or ribbons can be operably connected to replacement heart valves such as mitral or aortic valves, for example, for anchoring and stabilization. In some embodiments, the clips or ribbons can exert a force to clip or otherwise attach onto one or more native valve leaflets, in order to anchor a replacement heart valve in the valve annulus.

Turning now to <FIG>, an embodiment of the coaptation assistance device <NUM> is shown. The coaptation assistance device <NUM> can be substantially similar to the coaptation assistance device <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described herein. The coaptation assistance device <NUM> can include frame <NUM> configured to provide structural support to the coaptation assistance device <NUM>. In some embodiments, the frame <NUM> is collapsible to fit within a delivery catheter, such as implant delivery catheter <NUM>. In some embodiments, the frame <NUM> defines a superior edge <NUM>. The frame <NUM> can include anchor eyelets <NUM> configured to accept an anchor, such as anchor <NUM>. In some embodiments, such as shown in <FIG>, the eyelets <NUM> are configured to accept a trigonal anchor such as anchor <NUM>. In some embodiments, the eyelets <NUM> correspond to the region of the coaptation assistance device <NUM> that may be secured to the anterior and posterior fibrous trigones <NUM>, <NUM>. In some embodiments, the coaptation assistance device <NUM> comprises a ventricular anchor hub <NUM>. In some embodiments, the hub <NUM> provides an attachment structure for a ventricular anchor <NUM>.

The coaptation assistance device <NUM> comprises a body <NUM>. The body <NUM> comprises a first surface <NUM> disposed toward a mal-coapting native leaflet, in the instance of a mitral valve <NUM>, the posterior leaflet <NUM> and a second surface <NUM> which may be disposed toward the anterior leaflet <NUM>. The first and second surfaces <NUM>, <NUM> can be considered cooptation surface. The coaptation assistance device <NUM> can have a geometry which permits it to traverse the mitral valve <NUM> between attachment sites in the left atrium <NUM> and left ventricle <NUM>, to provide a coaptation surfaces <NUM> for the anterior leaflet <NUM> to coapt against, and attach to the atrium <NUM> or annulus <NUM> such that it effectively seals off the posterior leaflet <NUM>. In the instance that the posterior leaflet <NUM> is or has been removed, the coaptation assistance device <NUM> replaces the posterior leaflet <NUM>.

In some embodiments, the coaptation surface <NUM> of the coaptation enhancement element passes superiorly and radially inwardly from the superior edge, before passing distally, in a longitudinal direction perpendicular to the valve plane, or radially inwardly or outwardly with respect to the valve plane.

In some embodiments, the anterior surface <NUM> and posterior surface <NUM> of the coaptation assist device <NUM> further comprise a covering comprised of ePTFE, polyurethane foam, polycarbonate foam, biologic tissue such as porcine pericardium, or silicone.

One possible frame <NUM> is shown, with frame connecting the eyelets <NUM>. Other frame elements may be incorporated into the coaptation assistance device <NUM>. The frame <NUM> may be shaped in any number of ways to assist in maintaining the desired shape and curvature of the coaptation assistance device <NUM>. The frame can be made of Nitinol, stainless steel, polymer or other appropriate materials, can substantially assist in maintain the geometry of the coaptation assistance device <NUM>, permitting choice of any of a wide variety of covering materials best suited for long term implantation in the heart and for coaptation against the anterior leaflet <NUM>.

The coaptation assistance device <NUM> may include one or a plurality of anchors to stabilize the coaptation assistance device <NUM>, with the anchors optionally providing redundant fixation. The anchors may include a plurality of barbs for acute fixation to the surrounding tissue. In other embodiments, the anchors may comprise a plurality of helixes, clips, harpoon or barb-shaped anchors, or the like, appropriate for screwing or engaging into the annulus of the mitral valve <NUM>, tissues of the left ventricle <NUM>, and/or other tissues of the left atrium <NUM>. The anchors may attach to the tissue by welding using RF or other energy delivered via the elongate anchor coupling body.

Referring now to <FIG>, the implantation steps of one implementation of the method is shown. As shown in <FIG>, a delivery catheter <NUM> is advanced into the left atrium <NUM>. The delivery catheter <NUM> can be substantially similar to implant delivery catheter <NUM>. In some embodiments, the delivery catheter <NUM> may be advanced through the outer transseptal sheath <NUM> and into the left atrium <NUM>. <FIG> shows an embodiment of the delivery catheter <NUM>. The delivery catheter <NUM> may include a shaft <NUM> made of a polymer for example. In some embodiments, the shaft <NUM> is a braid or coil reinforced polymer shaft. In some embodiments, the shaft <NUM> has multiple durometers. In other embodiments, the delivery catheter <NUM> comprises an actively deflectable tip <NUM> to facilitate navigation of one or more anchors <NUM> to the anchoring sites. For instance, the deflectable tip <NUM> can access the site under the posterior leaflet. The delivery catheter <NUM> may include a deflection knob <NUM> to control the deflectable tip <NUM>.

The delivery catheter may include a drive shaft <NUM>. The drive shaft <NUM> has a feature at the tip to engage with and allow transmission of torque to the anchor <NUM>. In some embodiments, the drive shaft <NUM> is flexible. In some embodiments, the drive shaft <NUM> is capable of being advanced or retracted. The delivery catheter <NUM> may include a knob <NUM> that is connected to the drive shaft <NUM>. The knob <NUM> is internally connected to the drive shaft <NUM> thereby allowing transmission of torque to the anchor <NUM> when the knob <NUM> is rotated. This enables simple manipulation of the anchor position and torque.

The coaptation assistance device <NUM> can be delivered by the delivery catheter <NUM> and may be capable of expanding from a smaller profile to a larger profile to dimensions appropriate for placement in between the valve's native leaflets <NUM>, <NUM>. The coaptation assistance device <NUM> is expanded as it is exposed from the tip of the delivery catheter <NUM>. In some embodiments, the delivery catheter <NUM> is pulled back to expose the coaptation assistance device <NUM>. The delivery catheter <NUM> may further include a control handle <NUM> to manipulate the coaptation assistance device <NUM> and/or, to manipulate the docking and undocking of the coaptation assistance device <NUM> with the delivery catheter <NUM> and/or to facilitate placement of the coaptation assistance device <NUM>.

Referring now to <FIG>, the distal end of the delivery catheter <NUM> moves within the left atrium <NUM> by manipulating the control handle <NUM> and by articulating the actuator of deflection knob <NUM> so as to selectively bend the deflectable tip <NUM> and/or the distal end of the delivery catheter <NUM>. The deflectable tip <NUM> and/or the distal end of the delivery catheter <NUM> can be brought into alignment and/or engagement with candidate locations for deployment of the anchor <NUM>. The deflectable tip <NUM> and/or distal end of the delivery catheter <NUM> can be deflected to access the site under the posterior leaflet <NUM>. In some embodiments, the distal end of the delivery catheter <NUM> is brought into alignment with the wall of the left ventricle <NUM> to facilitate placement of the ventricle hub <NUM> and/or ventricle anchor <NUM>.

As shown in <FIG>, the trigonal anchors <NUM> are delivered and engaged as described herein. The coaptation assistance device <NUM> is extended through the mitral valve <NUM> into the left ventricle <NUM>. In some embodiments, the coaptation assistance device <NUM> may have a ventricular hub <NUM> and/or ventricular anchor <NUM>. The ventricular anchor <NUM> as shown is a helical anchor, but other anchor designs are contemplated. In some embodiments, the ventricular anchor <NUM> extends from the left ventricle <NUM> to the left atrium <NUM> as shown.

As shown in <FIG>, the coaptation assistance device <NUM> is anchored and the delivery catheter <NUM> is removed. The coaptation surface <NUM> is placed between the anterior leaflet <NUM> and the posterior leaflet <NUM>. The ventricular anchor <NUM> and the trigonal anchors <NUM> are secured. In some embodiments, there is an anteriolateral trigonal anchor <NUM> and a posteriomedial trigonal anchor <NUM> as shown in <FIG>.

The aforementioned method can be performed by a physician. In one embodiment, the manufacturer can provide one, some or all of the following: coaptation assistance device <NUM>, delivery catheter <NUM>, trigonal anchor <NUM>, and ventricular anchor <NUM>. In some embodiments, the manufacturer provides a kit containing some or all of the devices previously described.

Claim 1:
An implant (<NUM>) for treating mal-coaptation of a heart valve, the heart valve having an annulus (<NUM>) and first and second native leaflets with an open configuration and a closed configuration, the implant (<NUM>) comprising:
a coaptation assist body (<NUM>) having a first coaptation surface configured to be disposed toward the native posterior leaflet (<NUM>), an opposed second surface configured to be disposed toward the native anterior leaflet (<NUM>),
wherein, during use, the coaptation assist body (<NUM>) is disposed between the native leaflets to close the gap caused by mal-coaptation of the native leaflets (<NUM>, <NUM>) by providing a surface for the anterior native leaflet (<NUM>) to coapt against, while effectively replacing the posterior native leaflet (<NUM>) in the area of the valve which it would occlude during systole, were it functioning normally;
wherein the coaptation assist body (<NUM>) is elongate and narrow between anterior and posterior surfaces;
wherein a superior edge of the coaptation assist body (<NUM>) is curved to match the general shape of the annulus (<NUM>) or adjoining atrial wall;
wherein the coaptation assist body (<NUM>) comprises at least one ribbon (<NUM>), wherein the at least one ribbon (<NUM>) resists movement of the implant (<NUM>), wherein the at least one ribbon (<NUM>) extends in a direction from the coaptation assist body (<NUM>), wherein the at least one ribbon (<NUM>) comprises a shape memory material having a preformed shape with at least one curve, wherein the ribbon is movable from a first compressed configuration to a second expanded configuration, characterized in that the at least one ribbon (<NUM>) has a generally U-shaped configuration, and wherein the at least one ribbon (<NUM>) is configured to abut tissue and the at least one ribbon (<NUM>) has a bias such that the at least one ribbon (<NUM>) exerts a force and rests against the tissue of the heart.