Intercommissural leaflet supports

Abstract

The anchor (40) is anchorable to tissue of a ventricle downstream of a heart valve of a subject. Each wing (22) of the pair of wings defines an outer surface (24) and an inner surface (26) such that the inner surface of one wing of the pair faces the inner surface of the other wing of the pair. The wings are coupled to the anchor such that when the anchor is anchored to tissue, the anchor supports the wings at the valve and the outer surface of each wing faces a respective leaflet of the valve. During systole, the outer surface of each wing contacts a respective leaflet and the inner surfaces of the wings move into contact with each other to impede retrograde blood flow. During diastole, the inner surfaces move out of contact with each other to promote antegrade blood flow. Other implementations are also described.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 138,299, entitled “Intercommissural leaflet support” (Herman et al.), filed January 15, 2021, and incorporated herein by reference. [Background technology]

[0002] Certain cardiac pathologies, such as dilatation of the heart valve annulus and ruptured chordae tendineae, can prevent the leaflets from fully coapting when the valve is closed and / or result in flapping leaflets. Regurgitation of blood from the ventricles to the atria can result in increased total stroke volume and decreased cardiac output, and eventual collapse of the ventricles secondary to atrial volume and pressure overload. Summary of the Invention

[0003] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in the examples of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized herein. [Means for solving the problem]

[0004] Some applications herein are directed to systems, devices, and methods for using leaflet supports to reduce regurgitation in a subject's heart valve. The leaflet supports can provide an alternative coaptation surface and / or can restrain the leaflets from flapping.

[0005] In some applications, leaflet supports are used to facilitate function of a heart valve. In some such applications, the leaflet supports facilitate antegrade blood flow through the valve during diastole. In some such applications, the leaflet supports prevent retrograde blood flow through the valve during systole.

[0006] In some applications, the leaflet support includes a pair of wings, each wing defining (i) an inner surface that faces the inner surface of the other wing, and (ii) an outer surface that faces away from the other wing. Often in such applications, the leaflet support is implanted (e.g., anchored to ventricular tissue) such that the outer surface of each wing faces a respective leaflet of the valve.

[0007] Additionally, in applications where the leaflet support includes a pair of wings, the leaflet support can be implanted to prevent retrograde blood flow during systole by (i) the inner surfaces of the wings contacting each other and (ii) the outer surfaces of the wings contacting the leaflets.

[0008] Additionally, in applications where the leaflet support includes a pair of wings, the leaflet support can be implanted to promote antegrade blood flow during diastole by moving the inner surfaces of the wings out of contact with each other.

[0009] In some applications, the outer surface continues to contact the leaflets during diastole. In some such applications, the wings are affixed to the leaflets. For example, the wings can be stapled and / or glued to the leaflets. Alternatively or additionally, the wings can include a material that promotes tissue ingrowth in contact with the outer surface. For example, the wings can include an integrin binding ligand.

[0010] In some applications, the leaflet support includes a coaptation element and a fixator. Often in such applications, the fixator is positioned behind a downstream surface of the leaflets of the valve such that the fixator supports the coaptation element between the first leaflet and the second leaflet (e.g., below or above the ventricular side of the leaflets). In this way, the second leaflet (i) coapts with the coaptation element during systole and (ii) is biased against the coaptation element during diastole.

[0011] More often, in applications where the leaflet support includes a fixator, the fixator passively fills with blood after implantation. In some such applications, the fixator filling with blood facilitates fixation of the fixator to the implantation site (e.g., by increasing the volume of the fixator). For example, the fixator may include an absorbent material and / or a shape memory material.

[0012] In some such applications, the blood-filled fixator can facilitate coaptation of the coaptation element with the second leaflet during systole, For example, the blood-filled fixator can press the first leaflet against the coaptation element and / or can press the first leaflet towards the second leaflet.

[0013] Thus, according to some applications, there is provided a system and / or device for use with a valve of a subject's heart, cardiac circulation between systole and diastole, and the system and / or device includes a valve leaflet support, in some applications, the valve leaflet support includes a tissue anchor securable to ventricular tissue of a ventricle downstream of the valve, and a pair of wings.

[0014] In some applications, each wing of a pair of windows defines an inner surface, such that the inner surface of one wing of the pair faces the inner surface of the other wing of the pair, and an outer surface.

[0015] In some applications, the pair of wings is coupled to the tissue anchor such that when the tissue anchor is secured to the ventricular tissue, the tissue anchor flexibly supports the pair of wings on the valve. In some applications, the pair of wings are configured and / or supported such that during systole, an outer surface of each wing of the pair contacts a respective leaflet of the valve and inner surfaces of the pair of wings contact each other, such that the inner surfaces of the pair of wings move into contact with each other, thereby impeding retrograde blood flow through the valve. During diastole, the inner surfaces of the wings move out of contact with each other, thereby facilitating antegrade blood flow through the valve.

[0016] Thus, according to some applications, there is provided a system and / or device for use with a valve of a subject's heart, cardiac circulation between systole and diastole, and a system and / or device including a leaflet support. For some applications, the leaflet support includes a tissue anchor that is anchorable to ventricular tissue of a ventricle downstream of the valve, and wings. The wings have an outer surface configured to face and contact a first leaflet, and an opposing inner surface configured to face a valve opening and a second leaflet.

[0017] For some applications, the wings are coupled to the tissue anchors such that when the tissue anchors are secured to the ventricular tissue, the tissue anchors flexibly support the wings at the valve. For some applications, the wings are configured and / or supported such that during systole, an outer surface contacts the first leaflet and an inner surface moves to contact the second leaflet, thereby impeding retrograde blood flow through the valve. During diastole, an inner surface of the wings moves out of contact with the second leaflet, thereby facilitating antegrade blood flow through the valve.

[0018] In some applications, the outer surface includes the entire area of ​​the wing.

[0019] For some applications, the leaflet support has a delivery state configured such that the leaflet support is transluminally advanceable relative to the valve.

[0020] For some applications, the pair of wings is a first pair of wings and the leaflet support includes a second pair of wings. hi some applications, the leaflet support includes a third pair of wings.

[0021] For some applications, each wing of the pair includes a material that is impermeable to blood.

[0022] In some applications, each wing of the pair includes pericardial tissue.

[0023] For some applications, the pair of wings are configured such that each wing of the pair remains in contact with a respective leaflet during diastole when the tissue anchor is anchored to ventricular tissue.

[0024] For some applications, the pair of wings are configured such that an outer surface of each wing of the pair remains in contact with a respective leaflet during diastole when the tissue anchor is anchored to ventricular tissue.

[0025] For some applications, the leaflet support includes a flexible frame, with each wing of the pair fixed to the frame.

[0026] In some applications, the frame is elastically deformable.

[0027] In some applications, the frame is configured to bias the pair of wings away from each other.

[0028] In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of less than 30 g. For example, the wings may be pushed into contact with each other by a first force applied to the first wing and a second force applied to the second wing, such that the total convergence force (i.e., the sum of the first force and the second force) is less than 30 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 0.1 to 30 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 1 to 30 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of less than 20 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 0.1 to 20 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 1 to 20 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of less than 10 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 0.1 to 10 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 1 to 10 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of less than 5 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 0.1 to 5 g. In some applications, the frame is sufficiently flexible that the pair of wings can be pushed into contact with each other by a total convergence force of 1 to 5 g.

[0029] For some applications, each wing of the pair includes a fabric. For some applications, the fabric includes a polyester fabric.

[0030] For some applications, each wing of the pair comprises an integrin-binding ligand.

[0031] For some applications, each wing of the pair comprises fibronectin.

[0032] For some applications, each wing of the pair comprises vitronectin.

[0033] For some applications, each wing of the pair comprises collagen.

[0034] For some applications, each wing of the pair comprises laminin.

[0035] Further, according to some applications, there is provided a method for use with a valve of a subject's heart, the valve being upstream of a ventricle of the heart, and the method including transluminally advancing a leaflet support relative to the heart. For some applications, the leaflet support includes a tissue anchor and a pair of wings, each wing of the pair defining an inner surface and an outer surface. The method further includes anchoring the tissue anchor to ventricular tissue of the ventricle.

[0036] In some applications, the method includes positioning the leaflet support within the heart such that the tissue anchor flexibly supports the pair of wings with the valve. In some applications, this includes positioning the leaflet support such that an outer surface of each wing of the pair faces a respective leaflet of the valve and inner surfaces of the pair of wings face each other. In some applications, the leaflet support is positioned such that during systole, the outer surface of each wing contacts a respective leaflet and the inner surfaces of the wings move into contact with each other, thereby obstructing retrograde blood flow therebetween, and during diastole, the inner surfaces of the wings move out of contact with each other, thereby facilitating antegrade blood flow therebetween.

[0037] In some applications, positioning the leaflet support within the heart such that the tissue anchor flexibly supports the pair of wings on the valve includes positioning the leaflet support within the heart such that each wing of the pair extends from a first commissure of the valve to a second commissure of the valve.

[0038] In some applications, positioning the leaflet support within the heart includes positioning the leaflet support within the heart such that during diastole, an outer surface of each wing of the pair remains in contact with a respective leaflet, thereby impeding antegrade blood flow between the respective outer surface and the respective leaflet, and an inner surface of the pair of wings moves away from one another to define an inner passage therebetween, thereby facilitating antegrade blood flow through the inner passage.

[0039] In some applications, positioning the leaflet support within the heart includes coupling a pair of wings to a tissue anchor and then anchoring the tissue anchor to ventricular tissue.

[0040] In some applications, the valve is a tricuspid valve of the heart, and positioning the leaflet support within the heart such that the tissue anchors flexibly support the pair of wings at the valve includes positioning the leaflet support within the heart such that the tissue anchors flexibly support the pair of wings at the tricuspid valve.

[0041] In some applications, the valve is a mitral valve of the heart, and positioning the leaflet support within the heart such that the tissue anchor flexibly supports the pair of wings at the valve includes positioning the leaflet support within the heart such that the tissue anchor flexibly supports the pair of wings at the mitral valve.

[0042] In some applications, anchoring the tissue anchor to ventricular tissue of the ventricle includes anchoring the tissue anchor to a papillary muscle of the ventricle.

[0043] For some applications, the method includes affixing an outer surface of at least one of the pair of wings to a respective leaflet of the valve.

[0044] For some applications, affixing the outer surface of the at least one wing to the respective leaflet of the valve includes fastening the outer surface of the at least one wing to the respective leaflet of the valve using staples.

[0045] For some applications, affixing an outer surface of the at least one wing to a respective leaflet of the valve includes adhering an outer surface of the at least one wing to a respective leaflet of the valve using an adhesive.

[0046] The above methods can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), or the like. Further, according to some applications, a system and / or device is provided for use with a valve of a subject's heart, the valve having a first leaflet and a second leaflet, the system and / or device including a leaflet support, hi some applications, the leaflet support including a coaptation element having a first leaflet contacting surface and a second leaflet contacting surface, and a fixator fixedly coupled to the coaptation element.

[0047] In some applications, the fixator is implantable at a site behind the downstream surface of the first leaflet (e.g., below or above the ventricular side of the leaflet) and is configured to passively fill with blood while positioned behind the downstream surface of the first leaflet and to support a coaptation element between the first and second leaflets such that the second leaflet contacts the coaptation element during systole of the heart.

[0048] In some applications, the leaflet support has a delivery state, in which the leaflet support collapses for transluminal advancement relative to the valve.

[0049] For some applications, the fixator includes a shape memory structure.

[0050] For some applications, the fixator includes an absorbent material, the absorbent material configured to passively fill with blood.

[0051] For some applications, the fixator is configured such that the absorbent material passively fills with blood while the leaflet support is implanted at the site, thereby securing the fixator at the site.

[0052] For some applications, the fixator is configured such that the absorbent material passively fills with blood while the leaflet support is implanted at the site, thereby pushing the first leaflet towards the second leaflet. For some applications, the fixator is configured such that the absorbent material passively fills with blood while the leaflet support is implanted at the site, thereby pressing the first leaflet against the first leaflet contact surface of the coaptation element.

[0053] In some applications, the leaflet support includes a flexible frame, and the coaptation element is secured on the frame.

[0054] In some applications, the frame is elastically deformable.

[0055] In some applications, the frame is biased such that the frame maintains a first leaflet contact surface in contact with the first leaflet while the fixator is implanted at the site and supports a coaptation element between the first leaflet and the second leaflet.

[0056] In some applications, the interface element comprises a fabric. In some applications, the fabric comprises a polyester fabric.

[0057] In some applications, the interface element comprises an integrin-binding ligand.

[0058] For some applications, the joining elements include fibronectin.

[0059] For some applications, the conjugation element comprises vitronectin.

[0060] For some applications, the joining element includes collagen.

[0061] For some applications, the conjugation element comprises laminin.

[0062] Further, in accordance with some applications, a method is provided for use with a valve of a subject's heart, the valve having a first leaflet and a second leaflet, the method including transluminally advancing a leaflet support relative to the valve, In some applications, the leaflet support includes a coaptation element having a first leaflet contacting surface and a second leaflet contacting surface, and a fixator fixedly coupled to the coaptation element.

[0063] The method may further include subsequently positioning the fixator at a location posterior to the downstream surface of the first leaflet such that the fixator expands from a contracted state to an expanded state, passively fills with blood, and supports the coaptation element between the first leaflet and the second leaflet such that the second leaflet coapts with the coaptation element during systole of the heart.

[0064] In some applications, positioning the fixator at a site behind the downstream surface of the first leaflet to support a coaptation element between the first leaflet and the second leaflet includes positioning the fixator at a site such that the coaptation element extends from a first commissure of the valve to a second commissure of the valve.

[0065] In some applications, positioning the fixator at a location behind the downstream surface of the first leaflet to support a coaptation element between the first leaflet and the second leaflet includes positioning the fixator at a location such that the first leaflet contact surface maintains constant contact with the first leaflet.

[0066] For some applications, placing the fixator at the site includes placing the fixator between the chordae tendineae of the heart.

[0067] For some applications, placing the fixator at the site includes placing the fixator behind a chordae tendineae connected to the first leaflet.

[0068] For some applications, placing the fixator at the site includes placing the fixator in a subannular groove of the valve.

[0069] In some applications, positioning the fixator at a location posterior to the downstream surface of the first leaflet such that the fixator expands from a contracted state to an expanded state includes positioning the fixator at a location such that the fixator presses the first leaflet against the coaptation element.

[0070] In some applications, positioning the fixator at a location posterior to the downstream surface of the first leaflet such that the fixator expands from a contracted state to an expanded state includes positioning the fixator at a location such that the fixator urges the first leaflet toward the second leaflet.

[0071] For some applications, placing the fixator at the site such that the fixator passively fills with blood includes placing the fixator at the site such that passive filling with blood secures the fixator to the site.

[0072] For some applications, the fixator includes an absorbent material, and placing the fixator at the site includes placing the fixator at the site such that the absorbent material passively fills with blood.

[0073] In some applications, the valve is a mitral valve of the heart. Transluminally advancing the leaflet support into the valve includes transluminally advancing the leaflet support into the mitral valve.

[0074] In some applications, the first leaflet is a posterior leaflet of the mitral valve, the second leaflet is an anterior leaflet of the mitral valve, the site is a site behind a downstream surface of the posterior leaflet, and placing the fixator at the site includes placing the fixator at the site behind the downstream surface of the posterior leaflet.

[0075] The above methods can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), or the like.

[0076] Further, according to some applications, a system and / or device is provided for use with a valve of a subject's heart, the valve having a first leaflet and a second leaflet, and the system and / or device includes a leaflet support. For some applications, the leaflet support includes a coaptation element having a first leaflet contacting surface and a second leaflet contacting surface, and a fixator coupled to the coaptation element.

[0077] In some applications, the fixator can be implantable at a site downstream of the valve, e.g., within the ventricle, and configured to support a coaptation element between the first and first leaflets such that during systole of the heart, the first leaflet contacts the first leaflet contact surface and the second leaflet coapts with the second leaflet contact surface.

[0078] In some applications, during diastole, the first leaflet remains in contact with the first leaflet contact surface, while the second leaflet moves away from the second leaflet contact surface, thereby facilitating antegrade blood flow through the valve.

[0079] In some applications, the fixator can be implantable at a site behind the downstream surface of the first leaflet and configured to passively fill with blood while disposed behind the downstream surface of the first leaflet.

[0080] In some applications, the fixator may be a tissue anchor that can be secured to ventricular tissue of the ventricle downstream of the valve.

[0081] The present invention will be more fully understood from the following detailed description taken in conjunction with the drawings, in which: [Brief description of the drawings]

[0082] [Figure 1] 1-2 are schematic diagrams illustrating a leaflet support and its use to facilitate coaptation of the leaflets of a valve in a subject's heart, according to some applications. [Diagram 2] 1-2 are schematic diagrams illustrating a leaflet support and its use to facilitate coaptation of the leaflets of a valve in a subject's heart, according to some applications. [Diagram 3]3-4 are schematic diagrams illustrating a leaflet support and its use to facilitate coaptation of the leaflets of a valve, according to some applications. [Figure 4] 3-4 are schematic diagrams illustrating a leaflet support and its use to facilitate coaptation of the leaflets of a valve, according to some applications. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0083] Reference is now made to Figures 1-2, which are schematic diagrams illustrating a leaflet support 20 and its use to facilitate coaptation of leaflets 61, 63 of a valve 60 of a subject's heart 90, according to some applications.

[0084] The leaflet support 20 includes a pair of wings 22 (e.g., a first wing 22a and a second wing 22b) that are coupled to one another such that, when the leaflet support is implanted in a heart 90, (i) during systole, the inner surfaces of the pair of wings move into contact with one another, thereby impeding retrograde blood flow through the valve, and (ii) during diastole, the inner surfaces of the wings move out of contact with one another, thereby promoting antegrade blood flow through the valve. For example, and as shown in FIG. 1, the wings 22 may be coupled to one another via a flexible frame 30, such as a wire.

[0085] In some applications, and as shown, the wings 22 are positioned such that each wing has an inner surface 26 that faces the inner surface of the other wing and an outer surface 24 that faces away from the other wing. In some such applications, and as shown, the wings 22 may be shaped as contoured sheets that curve away from one another as they extend (e.g., extend upstream) along the contours of each of the leaflets 61, 63. For example, the upstream wing span d1 between the upstream ends of the wings may be greater than the downstream wing span d2 between the downstream ends of the wings.

[0086] In some applications, and as illustrated, the support 20 further comprises a tissue anchor 40 (e.g., a pair of tissue anchors 40a, 40b). Often in such applications, the support 20 is coupled to the anchor 40 such that the anchor flexibly supports the wings 22 at the valve 60. In some applications (not shown), the anchor 40 is coupled directly to the frame 30 of the support 20. In some applications, and as illustrated, a rod 42 is used to couple the wings 22 to the anchor 40. In some applications (not shown), the frame 30 comprises a hinge (e.g., by a hinge coupling the frame to the anchor 40 and / or the rod 42).

[0087] In some applications, and as shown, the wings 22 are secured onto a flexible frame (e.g., wire) 30 such that the frame acts as a scaffold for the wings. The wings 22 may be made of a material that is more flexible than the frame, so that the wings can generally assume a shape defined by the frame. For example, and as shown, the frame 30 may be secured along one or more edges of the wings 22. Alternatively or additionally, it may be desirable for the frame 30 to support the wings 22 between the edges.

[0088] In some applications, the frame 30 is elastically deformable (e.g., comprises an elastic, superelastic, or shape memory material such as Nitinol) and is biased to keep the wings 22 apart in the absence of a force applied thereto. In some such applications, the frame 30 is sufficiently flexible that the wings 22 can be brought into contact with each other by forces experienced during systole (e.g., forces exerted by blood and / or leaflets 61, 63). For example, the frame 30 may be sufficiently flexible to allow the wings 22 to be pushed into contact with one another (e.g., during systole) by a total inward pushing force (i.e., convergence force) of less than 30 g (e.g., less than 20 g, e.g., less than 10 g, e.g., less than 5 g) and / or more than 0.1 g (e.g., more than 1 g), e.g., 0.1-30 g (e.g., 0.1-20 g, 0.1-10 g, e.g., 0.1-5 g) or 1-30 g (e.g., 1-20 g, e.g., 1-10 g, e.g., 1-5 g). Such a configuration is hypothesized to facilitate maintenance of contact between the leaflets 61, 63 and the wings 22 as the heart cycles from diastole to systole.

[0089] 2 shows the support 20 implanted in the heart 90 (e.g., after the support has been advanced transluminally in a delivery state in which the frame 30 and / or wings 22 are compressed, and after the support has subsequently expanded within the heart). In some applications, and as shown, the anchor 40 is secured to tissue of the left ventricle 64 downstream of the mitral valve 60 (e.g., its papillary muscles 66). Although the support 20 is described herein as being used to promote coaptation of the leaflets of the mitral valve 60 (e.g., the anterior leaflet 61 and the posterior leaflet 63), this is not intended to exclude the use of the support 20 in other valves of the heart 90, mutatis mutandis. Thus, while a pair of wings 22 may be sufficient to promote coaptation of the leaflets 61, 63 of the mitral valve 60, it may be desirable to position additional pairs of wings 22 in other valves. For example, in a tricuspid valve, it may be desirable to utilize two or three pairs of wings 22 (e.g., two or three pairs of leaflet supports 20, or leaflet supports that themselves include two or three pairs of wings).

[0090] In some applications, the wings 22 and leaflets 61, 63 move in line (e.g., toward and away from each other) as the heart cycles between diastole (left frame of FIG. 2) and systole (right frame of FIG. 2). It is noteworthy that in contrast to the leaflets of a prosthetic heart valve, where a first portion of one leaflet moves relative to a first portion of another leaflet while a second portion of each leaflet remains stationary (e.g., the second portion remains anchored to the valve frame), the wings 22 of the leaflet support 20 typically move in their entirety toward and away from each other. For example, both the upstream wing span d1 and the downstream wing span d2 increase during diastole and decrease during systole.

[0091] The leaflets of a prosthetic heart valve typically contact each other at the edges of the leaflets, but in some applications the inner surfaces 26 of the wings 22 contact each other on the plane of the wings but not at the edges of the wings.

[0092] Typically, it is desirable for the wings 22 to facilitate antegrade (downstream) blood flow (e.g., from the left atrium 62 to the left ventricle 64, or through the mitral valve 60) during diastole (indicated by the arrows in the left frame of FIG. 2). During diastole, blood typically flows downstream through inner passages 68 between the inner surfaces 26 (e.g., between the inner surfaces 26a, 26b of each wing).

[0093] In some applications, each wing 22 (e.g., its outer surface 24) remains in contact with its respective leaflet 61, 63 during diastole. In some such applications, the resilience of the frame is such that the wings 22 apply a mild lateral pushing force against the leaflets 61, 63 while positioned therebetween, thereby maintaining the wings (e.g., their outer surface 24) in contact with the leaflets. It is hypothesized that the wings 22 contacting the leaflets during diastole helps to reduce obstruction of antegrade blood flow by the wings.

[0094] In some applications, maintaining contact between the outer surface 24 and the respective leaflets during diastole is facilitated by affixing the outer surface 24 to the leaflets 61, 63. For example, staples can be used to fasten each wing to the leaflets. Alternatively, or additionally, an adhesive can be used to adhere the outer surface to the leaflets. Still alternatively, or additionally, the outer surface 24 can include a material that promotes in-growth of the tissue of the leaflets 61, 63 onto the outer surface. For example, the outer surface 24 can include a fabric such as a polyester (e.g., polyethylene terephthalate) fabric, and / or an integrin binding ligand (e.g., fibronectin, vitronectin, collagen, and / or laminin).

[0095] In some applications, the wings 22 are sized to avoid obstruction of antegrade blood flow during diastole. For example, the entirety of each wing 22 may be positioned flat against its respective leaflet 61, 63 (e.g., the outer surface includes the entire area of ​​the wing 22) while the support is secured to the ventricular tissue. In this manner, the wings 22 may not be expected to impede significantly more antegrade blood flow than the leaflets.

[0096] In some applications, during systole, the coaptation between the inner surfaces 26 of the wings 22 closes the support 20 against blood flow therethrough. It is hypothesized that the contacts between (i) the outer surface 24a and the anterior leaflet 61, (ii) the outer surface 24b and the posterior leaflet 63, and (iii) the respective inner surfaces 26a and 26b, each alone and in tandem, obstruct retrograde blood flow through the mitral valve 60 during systole. It is further hypothesized that obstructing retrograde blood flow through the mitral valve 60 during systole may facilitate antegrade blood flow through the aortic valve 70 into the aorta 72 (illustrated by the arrows in the right frame of FIG. 2b).

[0097] In some applications, wings 22 include a material that is impermeable to blood. In some applications, wings 22 include pericardial tissue. It is hypothesized that such a material may facilitate occlusion of retrograde blood flow through mitral valve 60 during systole.

[0098] In some applications, the support 20 is dimensioned such that each wing 22 extends from a first commissure to a second commissure of the valve (e.g., from the anterior commissure to the posterior commissure of the mitral valve 60). It is hypothesized that each wing of the support 20 extending from commissure to commissure more effectively facilitates occlusion of retrograde blood flow by the support than if the wings 22 extended only partially between the commissures.

[0099] Reference is now made to Figures 3-4, which are schematic diagrams illustrating a leaflet support 120 and its use to facilitate coaptation of the leaflets 61, 63 of a valve 60, according to some applications.

[0100] Similar to support 20 described above, support 120 has been used to promote coaptation of mitral valve 60, however, this description is not intended to exclude the use of support 120 to promote coaptation of other valves of the heart, mutatis mutandis.

[0101] 3, the support 120 includes a fixator 128 coupled to the coaptation element 122. The support 120 is shown in an expanded operating state. However, the support 120 can be delivered transluminally to the valve 60 in a delivery state in which both the coaptation element 122 and the fixator 128 are compressed.

[0102] The support 120 shares some features with the support 20 described above. In particular, the coaptation element 122 shares some commonality with the wings 22 (although in contrast to the support 20 which includes a pair of wings, the support 120 includes a single coaptation element 122). For example, the coaptation element 122 may include a frame (e.g., including a shape memory material) 130 which acts as a scaffold defining the shape of the coaptation element. In some such applications, and as illustrated in FIG. 4, the frame 130 is biased to maintain the first leaflet contact surface 124 in contact (e.g., in constant contact) with the posterior leaflet 63.

[0103] In some applications, and as described above with reference to the outer surfaces 24 of the wings 22 of the support 20, the first leaflet contacting surface 124 includes a material that promotes the growth of tissue positioned within the first leaflet contacting surface (e.g., tissue of the posterior leaflet 63). For example, the first leaflet contacting surface 124 may include a fabric such as a polyester (e.g., polyethylene terephthalate) fabric, and / or an integrin binding ligand (e.g., fibronectin, vitronectin, collagen, and / or laminin).

[0104] As shown in Figure 4, the coaptation element 122 can be deployed such that the first leaflet contacting surface 124 faces the posterior leaflet 63 and the second leaflet contacting surface 126 faces the anterior leaflet 61. As illustrated in the right panel of Figure 4, the anterior leaflet 61 can coapt with the coaptation element 122 (e.g., its second leaflet contacting surface 126) during systole, impeding retrograde blood flow through the valve 60. During systole (left panel of Figure 4), the anterior leaflet 61 can deflect against the second leaflet contacting surface 126, promoting antegrade blood flow through the valve 60.

[0105] As discussed above, in conjunction with wings 22 of support 20, coaptation element 122 may extend from the anterior commissure of mitral valve 60 to the posterior commissure of the mitral valve. It is hypothesized that a coaptation element 122 extending from the anterior commissure to the posterior commissure will impede retrograde blood flow through mitral valve 60 during systole more effectively than support 120 where the coaptation element extends only partially between the commissures.

[0106] FIG. 4 shows the fixator 128 positioned (e.g., implanted) at an implantation site posterior (e.g., downstream) of the downstream surface 65 of the posterior leaflet 63 of the mitral valve 60. In some applications, the fixator 128 can be expanded and operative while positioned at the implantation site such that the fixator contacts the posterior leaflet 63 (e.g., its downstream surface 65) and other ventricular tissue (e.g., its chordae tendineae) of the heart 90. In some applications, the fixator 128 is positioned behind the posterior leaflet 63 and the chordae tendineae connected to the posterior leaflet, such as, for example, the annular groove. The fixator 128 expands after its implantation such that the volume it will ultimately occupy (e.g., the majority of it) is fixed in place. It is hypothesized that the contact between the fixator 128, the posterior leaflet 63, and other ventricular tissue may obviate the use of tissue anchors to secure the leaflet support 120.

[0107] In some applications, for example where the fixator 128 is positioned downstream of the mitral valve 60, the fixator 128 may be replaced by a tissue anchor, for example, tissue anchor 40, sharing the same characteristics as those described above with respect to Figures 1 and 2.

[0108] In some applications, expansion of the fixator 128 may push the posterior leaflet 63 against the coaptation element 122 (e.g., against its first leaflet contact surface 124) and / or may push the posterior leaflet toward the anterior leaflet 61. In some applications, it is hypothesized that this may facilitate coaptation of the anterior leaflet 61 and the coaptation element 122 during systole.

[0109] In some applications, the fixator 128 passively fills with blood upon implantation at the implantation site. In some such applications, the fixator 128 filling with blood facilitates securing the fixator 128 to the implantation site (e.g., by increasing the volume of the fixator, thereby increasing contact between the fixator and the implantation site). In some such applications, the fixator 128 includes an absorbent material. In some such applications, the absorbent material filling with blood promotes clotting of blood within the fixator 128 and / or tissue growth on the fixator. For example, clotting of blood within the fixator 128 may serve to secure the posterior leaflet 63 while the fixator is in contact with the posterior leaflet.

[0110] Alternatively, or in addition to including an absorbent material, the fixator 128 can further comprise a self-expanding structure. For example, a non-absorbable fixator 128 can include a shape memory spring or other structure.

[0111] The present invention is not limited to the embodiments specifically illustrated and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof not present in the prior art that would occur to one of ordinary skill in the art upon reading the above description. Furthermore, the techniques, methods, acts, steps, etc. described or suggested herein can be performed in live animals or in non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., body parts, tissues, etc. being simulated).

Claims

1. 1. A system for use with a valve of a subject's heart, the heart cycling between systole and diastole, the system comprising a leaflet support, the leaflet support comprising: a tissue anchor securable to ventricular tissue of a ventricle downstream of the valve; A pair of wings, each wing of the pair comprising: an inner surface, the inner surface of one wing of the pair facing the inner surface of the other wing of the pair; an outer surface; and a pair of wings defining an outer surface; the pair of wings are coupled to the tissue anchor such that, when the tissue anchor is secured to the ventricular tissue, the tissue anchor flexibly supports the pair of wings on the valve, and the outer surface of each wing of the pair faces a respective leaflet of the valve, such that: During systole, the outer surface of each wing of the pair contacts the respective leaflet; moving the inner surfaces of the pair of wings into contact with one another, thereby obstructing retrograde blood flow through the valve; During diastole, the inner surfaces of the wings move out of contact with one another, thereby facilitating antegrade blood flow through the valve.

2. The system of claim 1 , wherein the outer surface includes the entire area of ​​the wing.

3. The system of claim 1 , wherein the leaflet support has a delivery state configured such that the leaflet support is transluminally advanceable relative to the valve.

4. The system of claim 1 , wherein the pair of wings is a first pair of wings and the leaflet support further comprises a second pair of wings.

5. The system of claim 4 , wherein the leaflet support further comprises a third pair of wings.

6. 2. The system of claim 1, wherein the pair of wings are configured such that each wing of the pair remains in contact with its respective leaflet during diastole when the tissue anchor is secured to the ventricular tissue.

7. 7. The system of claim 6, wherein the pair of wings are configured such that the outer surface of each wing of the pair remains in contact with its respective leaflet during diastole when the tissue anchor is secured to the ventricular tissue.

8. The system of claim 1 , wherein the leaflet support further comprises a flexible frame, each wing of the pair being fixed onto the frame.

9. The system of claim 8 , wherein the frame is elastically deformable.

10. The system of claim 9 , wherein the frame is configured to bias the pair of the wings away from one another.

11. The system of claim 10 , wherein the frame is sufficiently flexible such that the pair of wings can be forced into contact with one another with a total convergent force of less than 30 g.

12. 12. The system of claim 11, wherein the frame is sufficiently flexible such that the pair of wings can be forced into contact with one another with a total convergent force of less than 20 g.

13. The system of claim 12 , wherein the frame is sufficiently flexible such that the pair of wings can be forced into contact with one another with a total convergent force of less than 10 g.

14. The system of claim 13, wherein the frame is sufficiently flexible such that the pair of wings can be forced into contact with one another with a total convergent force of 0.1 to 10 g.

15. The system of claim 14, wherein the frame is sufficiently flexible such that the pair of wings can be forced into contact with one another with a total convergent force of 1 to 10 g.

16. 14. The system of claim 13, wherein the frame is sufficiently flexible such that the pair of wings can be forced into contact with one another with a total convergent force of less than 5 g.

17. The system of claim 1 , wherein each wing of the pair comprises an integrin-binding ligand.

18. 20. The system of claim 17, wherein each wing of the pair comprises at least one of fibronectin, vitronectin, collagen, and laminin.

19. The system of claim 1 , wherein each wing of the pair comprises a material that is impermeable to blood.

20. The system of claim 1 , wherein each wing of the pair comprises pericardial tissue.

21. The system of claim 1 , wherein each wing of the pair comprises fabric.

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