Leaflet dilator

Abstract

A dilator (30) for a first leaflet of a heart valve, the first leaflet having a labrum and a root and the valve having a second leaflet. The dilator includes a first panel (62), a second panel (64), and an anchor (38) coupled to the first panel. For some applications, the second panel is articulably coupled to the first panel by an articulable coupling (66). The dilator is expandable by increasing the angular disposition between the first panel and the second panel, thereby increasing a size of an opening (40) between the panels on opposite sides of the articulable coupling. The dilator is collapsible by reducing the angular disposition. The anchor is configured to secure the first panel to the first leaflet such that the articulable coupling is disposed closer to the root than to the labrum and the opening. Other applications are also described.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 292,353 to Ruban et al., entitled "Leaflet Augmentor With extending Coaptation Surface," filed December 21, 2021, and is incorporated by reference herein for all purposes. [Background technology]

[0002] Heart valves are damaged by a variety of causes. Damaged valves can result in the backflow of blood from the ventricles to the atria during ventricular contraction, ultimately causing heart failure. Devices designed to prevent backflow through damaged valves can be useful. Summary of the Invention [Problem to be solved by 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 an example 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 in relevant parts of this disclosure may be included in the examples summarized herein. [Means for solving the problem]

[0004] Exemplary applications described herein are directed to systems, apparatus, devices, and methods for reducing regurgitation through a heart valve, for example, by reducing flutter, prolapse, or abnormal leaflet movement, and by improving coaptation between the leaflets of the valve. For example, leaflet dilators are described. The terms augmenter and augmentor, as used herein, are interchangeable and refer to the same object.

[0005] In some applications, the leaflet expander comprises two articulably coupled panels. The first panel is fixable to the leaflet of the first valve by an anchor, e.g., a tissue piercing element, a T-bar, a thread, a suture, a pin, a clip, or a locking element. The second panel is expandable or collapsible via the articulable coupling such that the second panel moves away from or toward the first panel during a stage of the cardiac contraction cycle. That is, during ventricular expansion, the second panel moves toward the first panel in response to blood flow through the valve, while during ventricular contraction, the second panel moves away from the first panel due to increased intraventricular pressure. When the valve closes, the second panel comes into coaptation with the leaflet of the second valve that did not properly coapt with the first leaflet prior to implantation of the expander.

[0006] In some applications, the flexible connector is disposed between the first and second panels in a manner that limits the expansion of the expander by limiting the angular extent of the opening between the first and second panels. In some applications, the flexible connector may connect the lip edges of the first and second panels. In some applications, the flexible connector may connect the side edges of the first and second panels.

[0007] The connector may include at least one wire, string, or thread. In some applications, the connector includes a flexible third panel. The third panel may include a permeable net, such as an open mesh fabric, a web of interwoven threads, or other substantially open structure. In some applications, the third panel has an accordion fold.

[0008] In some applications where the connector includes a third panel, the expander further includes a flexible fourth panel, e.g., the third and fourth panels each connecting a respective lateral edge of the first and second panels, such an arrangement can stabilize the expander and limit the extent of the opening between the first and second panels.

[0009] The connector may include a cell growth inhibitor.The connector may include a cell growth promoter.

[0010] The panels may have a substantially rectangular shape or a substantially oval shape, or may have a different suitable shape.

[0011] The panels can include a flexible fabric. In some applications, the fabric can have tissue growth promoting or inhibiting properties. In some such applications, one side of each panel can include a fabric having different properties than the fabric on the opposite side of the panel, and / or the fabric of one panel can have different properties than the fabric of the other panel.

[0012] In some applications, the expander comprises a frame, which may be elastic. In applications where the panels include a fabric, the frame may support the fabric. Each panel may comprise a two-layer fabric section into which the frame is inserted. The elastic frame may be pre-tensioned within the fabric frame.

[0013] In some applications where the expander comprises a frame, the frame itself may limit the expansion of the expander in addition to or instead of the expander comprising a flexible connector that limits the expansion of the expander. The articulatable coupling may also be part of a frame that is circumferentially disposed within one or both panels, as described herein below.

[0014] The expander may be biased toward the first and second panels having a predetermined angular arrangement therebetween. In some applications, the coupling between the first and second panels may contribute to limiting the expansion of the expander. A coupling may be used to bias the expander toward the two panels in either the collapsed or expanded state. In some applications, the stiffness of the articulatable coupling, e.g., a hinge, may be biased to respond to blood flow through the valve, such that the pressure of blood passing from the atrium to the ventricle of the heart during diastole tends to collapse the second panel against the first panel.

[0015] In some applications, the expander may be biased toward the expanded or collapsed state by means other than the articulatable coupling itself, for example, elasticity and / or shape memory of the frame may provide such bias.

[0016] In some applications, discrete springs (e.g., torsion springs, leaf springs, cantilever springs, or arc springs) can provide such biasing, for example, to give the expander clothes-pin-like properties (e.g., biased either open or closed).

[0017] In some applications, the leaflet dilator includes three panels arranged around a central axis and diverging from one another. In some applications, the panels may be arranged with equal angles between each pair, i.e., 120 degrees. In some applications, the panels may be arranged such that the first and second panels are arranged less than 120 degrees from one another and the third panel is arranged greater than 120 degrees from each of the other panels. The first of the three panels can be secured to the leaflet of the first valve via an anchor. The dilator can be configured such that during contraction, one or both of the second and third panels come into coaptation with the leaflet of the second valve that did not properly coapt with the first leaflet prior to implantation of the dilator.

[0018] According to some applications, a system and / or device is provided that includes a dilator for a first leaflet of a heart valve, the first leaflet having a labrum and a root, and the valve also having a second leaflet. In some applications, the dilator includes a first panel and a second panel articulably coupled to the first panel by an articulable coupling.

[0019] In some applications, the second panel may be articulably coupled to the first panel such that the expander is expandable by increasing the angular disposition between the first panel and the second panel, thereby increasing a dimension of an opening defined between the first panel and the second panel opposite the articulable coupling. In some applications, the expander is collapsible by reducing the angular disposition.

[0020] For some applications, the dilator may further include an anchor. For some applications, the anchor is coupled or coupleable to the first panel. For some applications, the anchor is configured to secure the first panel to the first leaflet such that the first panel is positioned against the first leaflet and the articulatable coupling is positioned closer to the root than the labrum and closer to the orifice.

[0021] For some applications, the anchor is configured to secure the first panel to the first leaflet such that the expander expands during ventricular contraction and collapses during ventricular expansion.

[0022] For some applications, the anchor is configured to secure the first panel to the first leaflet with the opening facing the ventricle.

[0023] In some applications, the system / device further includes a flexible connector connected to the first panel and the second panel in a manner that limits the expansion of the expander by limiting the angular alignment between the first panel and the second panel.

[0024] In some applications, the anchor is coupled to the first panel closer to the articulatable coupling than the lip edge of the first panel.

[0025] In some applications, each of the first panel and the second panel is substantially circular or elliptical in shape.

[0026] In some applications, each of the first panel and the second panel is substantially rectangular in shape.

[0027] For some applications, the first panel is sufficiently flexible to conform to the shape of the first leaflet.

[0028] For some applications, the first panel is sized such that securing the first panel to the first leaflet with the anchor causes the first leaflet to overhang beyond the lip edge of the first leaflet.

[0029] In some applications, the second panel is sized to extend beyond the edge of the first panel.

[0030] In some applications, the second panel is articulably joined to the first panel along the entire length of the edge of each panel.

[0031] In some applications, the second panel is articulably joined to the first panel along a partial length of an edge of each panel.

[0032] In some applications, the articulatable coupling includes a stitch.

[0033] In some applications, the articulable coupling includes a hinge.

[0034] In some applications, the articulable coupling includes a flexure.

[0035] For some applications, the anchor includes a clip.

[0036] For some applications, the anchor includes a tissue-piercing element.

[0037] For some applications, the expander is configured such that securing the first panel to the first leaflet with the anchor increases the efficiency of the valve to inhibit backflow of blood through the valve during ventricular contraction.

[0038] For some applications, the first panel is sized such that when the anchor secures the first panel to the first leaflet, the first panel extends beyond the lip of the first leaflet.

[0039] In some applications, the second panel is sized to extend beyond the edge of the first panel.

[0040] In some applications, the first leaflet is a fluttering leaflet and the dilator is configured to be secured to the fluttering first leaflet such that the second panel coapts with the second leaflet, thereby inhibiting flutter of the first leaflet.

[0041] In some applications, the second leaflet is a fluttering leaflet and the dilator is configured to be secured to the first leaflet such that the second panel coapts with the fluttering second leaflet, thereby inhibiting flutter of the second leaflet.

[0042] For some applications, the expander is configured such that expansion of the expander reduces backflow of blood through the valve while the first panel is secured to the first leaflet by the anchor.

[0043] For some applications, the expander includes a polymer that is shaped to define a first panel and a second panel.

[0044] For some applications, the expander includes silicone that is shaped to define a first panel and a second panel.

[0045] For some applications, the system / device further includes a tether coupled to and extending from the first panel and configured to be attached to ventricular tissue while the anchor secures the first panel to the first leaflet.

[0046] In some applications, the anchor is a leaflet anchor and the system / apparatus further includes a ventricular anchor coupled to the tether and configured to secure the tether to ventricular tissue while the leaflet anchor secures the first panel to the first leaflet.

[0047] In some applications, the ventricular tissue is ventricular wall tissue.

[0048] In some applications, the ventricular tissue is papillary muscle tissue.

[0049] For some applications, the ventricular anchor is coupled to the tether in a manner that facilitates adjustment of the tension in the tether.

[0050] In some applications, the system / device further includes a winch coupled to the ventricular anchor, the anchor being coupled to the tether via the winch such that tension in the tether is adjustable by actuation of the winch.

[0051] For some applications, at least the first panel includes a cell proliferation-inducing material.

[0052] For some applications, the second panel comprises a cell proliferation-inducing material.

[0053] For some applications, the second panel is formed from a cell growth inhibitory material.

[0054] For some applications, the first panel and the second panel each include a flexible fabric.

[0055] For some applications, the expander further includes at least one frame.

[0056] In some applications, the at least one frame serves to strengthen the fabric.

[0057] For some applications, the fabric of each of the first and second panels is disposed over at least one frame such that the frame supports the fabric.

[0058] In some applications, the frame is shaped to define a hoop.

[0059] In some applications, the frame has an H-shape, such that the crossbars of the H cross the faces of the panels.

[0060] In some applications, at least one frame is positioned along at least one edge of each panel.

[0061] For some applications, the at least one frame includes a first frame and a second frame, the first frame articulably coupled to the second frame.

[0062] For some applications, at least one frame includes a single, unitary frame having an articulation location where the second panel is articulably coupled to the first panel.

[0063] In some applications, the integral frame includes a resilient material that biases the first panel and the second panel into a predetermined angular arrangement therebetween.

[0064] For some applications, the unitary frame includes a resilient material that defines a flex connection between the first panel and the second panel.

[0065] In some applications, at least one frame is sewn to the fabric.

[0066] For some applications, for each of the first panel and the second panel, the flexible fabric defines a first fabric layer disposed over a first side of the at least one frame, hi some applications, the panel further includes a second fabric layer disposed over a second side of the at least one frame such that the frame is sandwiched between the first and second fabric layers.

[0067] In some applications, the frame and fabric are sized relative to one another so that the frame and fabric are pre-tensioned.

[0068] In some applications, when the fabric is placed on a frame, the frame provides a particular form and shape to the panel.

[0069] In some applications, the dilator is biased toward the first panel and the second panel and has a predetermined angular orientation therebetween.

[0070] In some applications, the expander is biased to collapse by reducing the angular orientation between the second panel and the first panel.

[0071] In some applications, the expander is biased to expand by increasing the angular alignment between the second panel and the first panel.

[0072] For some applications, the first panel has a lip opposite the articulable coupling and a lateral edge extending between the articulable coupling and the lip of the first panel. For some applications, the second panel has a lip opposite the articulable coupling and a lateral edge extending between the articulable coupling and the lip of the second panel. For some applications, the opening is defined by the lip of the first panel and the lip of the second panel.

[0073] In some applications, the system / device further includes a flexible connector connected to the first panel and the second panel in a manner that limits the expansion of the expander by limiting the angular alignment between the first panel and the second panel.

[0074] In some applications, the flexible connector is located opposite an articulatable coupling that extends between the first panel and the second panel.

[0075] In some applications, a flexible connector connects the lip of the first panel to the lip of the second panel.

[0076] In some applications, the flexible connector connects a substantially central portion of the lip of the first panel to a substantially central portion of the lip of the second panel.

[0077] For some applications, the flexible connector is a first flexible connector and the dilator further includes a second flexible connector. For some applications, the first flexible connector connects a first lateral portion of the lip of the first panel to a first lateral portion of the lip of the second panel.

[0078] In some applications, the second flexible connector connects a second side portion of the lip of the first panel substantially opposite the first side portion of the lip of the first panel to a second side portion of the lip of the second panel substantially opposite the first side portion of the lip of the second panel.

[0079] In some applications, the flexible connector connects (i) a portion on a first panel midway between the articulatable coupling and the lip of the first panel, and (ii) a portion on a second panel midway between the articulatable coupling and the lip of the second panel.

[0080] In some applications, a flexible connector connects a side edge of a first panel to a side edge of a second panel.

[0081] In some applications, the flexible connector includes a flexible third panel extending between the first panel and the second panel.

[0082] For some applications, the flexible connector includes a cell growth inhibitor.

[0083] For some applications, the flexible connector includes a cell growth promoting substance.

[0084] In some applications, a flexible third panel connects the lip of the first panel to the lip of the second panel.

[0085] For some applications, the third panel includes a fabric.

[0086] In some applications, the third panel includes netting.

[0087] For some applications, the anchor is configured to secure the first panel to the first leaflet such that the third panel coapts with the second leaflet during systole.

[0088] For some applications, the anchor is configured to secure the first panel to the first leaflet such that the third panel faces the ventricle during systole.

[0089] For some applications, the lateral edge of the first panel is the first lateral edge of the first panel. For some applications, the lateral edge of the second panel is a first lateral edge of the second panel substantially aligned with the first lateral edge of the first panel. For some applications, the first panel has a second lateral edge substantially opposite the first lateral edge of the first panel and extending between the articulable coupling and a lip edge of the first panel. For some applications, the second panel has a second lateral edge substantially opposite the first lateral edge of the second panel and extending between the articulable coupling and a lip edge of the second panel and substantially aligned with the second lateral edge of the first panel. For some applications, the third panel extends between the first lateral edge of the first panel and the first lateral edge of the second panel.

[0090] For some applications, the expander further includes a flexible fourth panel extending between the second lateral edge of the first panel and the second lateral edge of the second panel.

[0091] For some applications, the third panel and the fourth panel include folds configured to fold inwardly when the opening is folded.

[0092] For some applications, the flexible connector includes at least one connector element selected from the group consisting of wires and threads.

[0093] In some applications, the flexible connector includes exactly one connector element selected from the group.

[0094] In some applications, the anchor is coupled to the first panel closer to the articulatable coupling than the lip edge of the first panel.

[0095] For some applications, the anchor includes a toggle anchor.

[0096] For some applications, the toggle anchor has a blunt end and a sharp end and is configured to be advanced through the first leaflet from the sharp end.

[0097] In some applications, the anchor is coupled to the first panel by a flexible thread.

[0098] For some applications, the anchor is a first anchor and the dilator further includes a second anchor coupled to the first panel and configured to secure the first panel to the first leaflet.

[0099] For some applications, the first anchor includes a first toggle anchor and the second anchor includes a second toggle anchor.

[0100] In some applications, the expander is configured such that (i) the first panel is secured to the first leaflet, and (ii) while the articulatable coupling is positioned closer to the root than the labrum and the opening, blood flow within the heart transitions the expander toward its expanded configuration during ventricular contraction and toward its collapsed configuration during ventricular expansion.

[0101] For some applications, the system / device further includes a flexible connector connected to the first panel and the second panel in a manner that limits expansion of the expander during ventricular contraction.

[0102] According to some applications, a system and / or device is provided that includes a dilator for a first leaflet of a heart valve, the first leaflet having a labrum and a root, and the valve having a second leaflet. The system / device includes a first panel, a second panel, a third panel, and / or an anchor.

[0103] For some applications, each of the panels has a respective outer edge. For some applications, each of the panels extends inwardly from the outer edge such that the first, second, and third panels converge at an axis of the dilator. For some applications, each of the panels defines a panel plane substantially parallel to the axis. For some applications, the anchor is configured to secure the first panel to the first leaflet. For some applications, the dilator is sterile.

[0104] For some applications, the expander includes a polymer that is shaped to define a first panel, a second panel, and a third panel.

[0105] For some applications, the expander includes silicone that is shaped to define a first panel, a second panel, and a third panel.

[0106] For some applications, the anchor is configured to attach the first panel to the first leaflet such that the second panel extends away from the first panel toward the second leaflet.

[0107] For some applications, the anchor is configured to secure the first panel to the first leaflet such that the third panel extends away from the first panel toward the ventricle.

[0108] For some applications, the anchor is coupled to the first panel closer to an edge of the first panel than the shaft of the dilator.

[0109] In some applications, each of the first panel, the second panel, and the third panel are substantially circular or elliptical in shape.

[0110] In some applications, each of the first panel, the second panel, and the third panel are substantially rectangular in shape.

[0111] For some applications, the first panel is sufficiently flexible to conform to the shape of the first leaflet.

[0112] For some applications, the first panel is sized such that securing the first panel to the first leaflet with the anchor causes the third panel to extend beyond the lip edge of the first leaflet.

[0113] In some applications, the second panel and the third panel collectively define a surface, and the anchor is configured to secure the first panel to the first leaflet such that (i) the first panel is positioned against the first leaflet and (ii) the surface is presented as a coaptation surface to the second leaflet.

[0114] For some applications, the anchor is configured to secure the first panel to the first leaflet such that the third panel is disposed within the ventricle.

[0115] For some applications, the anchor is configured to secure the first panel to the first leaflet such that during ventricular contraction, the second panel moves away from the first panel and extends across an upstream surface of the second leaflet.

[0116] For some applications, the anchor is configured to secure the first panel to the first leaflet such that the second panel is disposed against an upstream surface of the second leaflet during ventricular contraction.

[0117] For some applications, the anchor is configured to secure the first panel to the first leaflet such that a lip edge of the second leaflet contacts the third panel during ventricular contraction.

[0118] For some applications, the system / device further includes a tether coupled to and extending from the first panel and configured to anchor the first panel to ventricular tissue of the heart.

[0119] In some applications, the anchor is a leaflet anchor and the system / apparatus further includes a ventricular anchor coupled to the tether and configured to secure the tether to ventricular tissue while the leaflet anchor secures the first panel to the first leaflet.

[0120] In some applications, the ventricular tissue is ventricular wall tissue.

[0121] In some applications, the ventricular tissue is papillary muscle tissue.

[0122] For some applications, the ventricular anchor is coupled to the tether in a manner that facilitates adjustment of the tension in the tether.

[0123] In some applications, the system / device further includes a winch coupled to the ventricular anchor, the anchor being coupled to the tether via the winch such that tension in the tether is adjustable by actuation of the winch.

[0124] For some applications, at least the first panel includes a cell proliferation-inducing material.

[0125] For some applications, the second panel comprises a cell proliferation-inducing material.

[0126] For some applications, the third panel comprises a cell proliferation-inducing material.

[0127] For some applications, the second panel comprises a cell growth inhibitory material.

[0128] For some applications, the third panel comprises a cell growth inhibitory material.

[0129] For some applications, the first panel, the second panel, and the third panel each include a flexible fabric.

[0130] For some applications, the expander further includes a frame.

[0131] In some applications, the frame serves to strengthen the fabric.

[0132] In some applications, the fabric of each of the first panel, the second panel, and the third panel is disposed on a frame such that the frame supports the fabric.

[0133] In some applications, for each of the first, second, and third panels, the frame extends along an outer edge of the panel substantially parallel to the axis.

[0134] In some applications, the frame includes a single, integral frame that defines the first panel, the second panel, and the third panel.

[0135] In some applications, the unitary frame includes a resilient material that biases the first panel, the second panel, and the third panel into a predetermined angular orientation relative to one another.

[0136] In some applications, the unitary frame comprises a resilient material.

[0137] In some applications, the frame is sewn to the fabric.

[0138] In some applications, for each of the first panel, the second panel, and the third panel, (i) the flexible fabric defines a first fabric layer disposed over a first side of the frame, and (ii) the panel further includes a second fabric layer disposed over a second side of the frame such that the frame is sandwiched between the first fabric layer and the second fabric layer.

[0139] In some applications, the frame and fabric are sized relative to one another so that the frame and fabric are pre-tensioned.

[0140] In some applications, when the fabric is placed over a frame, the frame provides a particular form and shape to the first panel, the second panel, and the third panel.

[0141] Further, according to some applications, a method is provided for use with a real or simulated heart valve having a first leaflet and a second leaflet, the method including advancing a dilator transluminally to the heart and securing the dilator to the first leaflet. For some applications, the dilator includes a first panel, a second panel articulably coupled to the first panel, and an anchor.

[0142] For some applications, the method includes securing a first panel of the expander to the first leaflet using an anchor such that the first panel is positioned relative to the first leaflet. For some applications, the method includes securing the first panel to the first leaflet using an anchor such that the second panel (i) deflects away from the first panel toward the second leaflet during ventricular contraction and (ii) deflects away from the second leaflet toward the first panel during ventricular diastole in response to blood flow in the heart.

[0143] In some applications, securing the first panel to the first leaflet includes securing the first panel to the first leaflet such that the second panel coapts with the second leaflet during ventricular contraction in response to blood flow in the heart, thereby reducing regurgitation through the valve.

[0144] In some applications, deflection of the second panel during ventricular contraction causes the second panel to coapt with the second leaflet.

[0145] For some applications, the method further includes anchoring the first panel to ventricular tissue using a tether connected to the first panel.

[0146] For some applications, the system and / or device further includes adjusting tension in the tether.

[0147] For some applications, anchoring the first panel to the ventricular tissue includes securing the tether to the ventricular tissue using a tissue anchor attached to the tether.

[0148] For some applications, the system / apparatus further includes coupling the tissue anchor to the tether via a winch.

[0149] In some applications, the system / apparatus further includes adjusting the tension of the tether by actuating a winch.

[0150] For some applications, the method further includes attaching a flexible third panel between the first panel and the second panel.

[0151] In some applications, deflection of the second panel during ventricular contraction accompanies a flexible third panel coapting with the second leaflet.

[0152] The above methods and steps may be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0153] According to some applications, a method is provided for use with a real or simulated heart valve having a first and second leaflet and disposed between an atrium and a ventricle of the heart, the method comprising: advancing a dilator transluminally to the heart and securing the dilator to the first leaflet. For some applications, the dilator comprises a first panel, a second panel, a third panel, and an anchor.

[0154] For some applications, the method includes securing a first panel to the first leaflet.

[0155] In some applications, each of the panels has a respective outer edge and extends inwardly from the outer edge such that the first, second, and third panels converge at the axis of the expander and define respective panel planes substantially parallel to the axis.

[0156] In some applications, securing the first panel to the first leaflet includes securing the first panel to the first leaflet while the second panel and the third panel are disposed within a delivery tool, and the method further includes thereafter deploying the second panel and / or the third panel from the delivery tool.

[0157] In some applications, deploying the second panel and the third panel from the delivery tool includes deploying the second panel and the third panel from the delivery tool such that the second panel and the third panel are biased away from one another.

[0158] The above methods and steps may be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0159] According to some applications, a system and / or device is provided that includes a leaflet dilator for use with a heart valve having at least a first leaflet and a second leaflet. For some applications, the system / device includes a first panel, a second panel articulably connected to the first panel, and a tissue-piercing element coupled to the first panel and configured to secure the first panel to the first leaflet, such that during ventricular contraction, closure of the valve involves articulation of the second panel away from the first panel and toward the second leaflet.

[0160] Any of the above systems, devices, instruments, etc. in this summary of the invention may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.), and the methods described herein may include sterilization of one or more of the systems, devices, instruments, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0161] The present invention will be more fully understood from the following detailed description of its application, taken together with the drawings. [Brief description of the drawings]

[0162] [Figure 1A] 1 is a schematic diagram of a subject native heart valve. [Figure 1B] 1 is a schematic diagram of a subject native heart valve. [Figure 1C] 1 is a schematic diagram of a subject native heart valve. [Figure 2A] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 2B] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 2C] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 2D] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 2E] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 2F]1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 3A] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 3B] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 3C] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 3D] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 3E] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 3F] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 4A] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 4B] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 4C] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 4D] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 4E] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 4F] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 5A] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 5B] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 5C] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 5D] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 5E] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 5F]1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 6A] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 6B] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 6C] 1 is a schematic diagram of an exemplary application of a leaflet dilator, in accordance with some applications. [Figure 7] 1 is a schematic diagram of an exemplary application of a system including a leaflet expander implanted in a native heart valve, according to some applications. [Figure 8] 1 is a schematic diagram of an exemplary application of a system including a leaflet expander implanted in a native heart valve, according to some applications. [Figure 9A] 1 is a schematic diagram showing a leaflet expander implanted in a native heart valve, according to some applications. [Figure 9B] 1 is a schematic diagram showing a leaflet expander implanted in a native heart valve, according to some applications. [Figure 10A] 1 is a schematic diagram of a leaflet dilator, according to some applications. [Figure 10B] 1 is a schematic diagram of a leaflet dilator, according to some applications. [Figure 10C] 1 is a schematic diagram of a leaflet dilator, according to some applications. [Figure 11] 1 is a schematic diagram showing a leaflet expander implanted in a heart valve, according to some applications. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0163] Reference is now made to Figures 1A-1C, which are schematic illustrations of a portion of a native valve 10 of a subject's heart 4 in various states. Figure 1A represents a heart having normal and / or healthy anatomical structure and function. The valve 10 includes a first leaflet 12 and at least a second leaflet 14, each of which has a root 13 that is attached, for example, to the annulus of the valve. For simplicity, only the root 13 of the first leaflet 12 is labeled. The valve 10 may be located between an atrium 6 and a ventricle 8 of the heart, i.e., an atrioventricular valve, such as the mitral valve or tricuspid valve. In some applications, the valve 10 may be a valve between a chamber of the heart and a major blood vessel leading into or out of the chamber. Figure 1A illustrates the heart 4 during ventricular systole, with the leaflets 12 and 14 coapting, thereby preventing the backflow of blood from the ventricle 8 into the atrium 6.

[0164] 1B and 1C show a heart 4 having a valve 10 in which the leaflets 12 and 14 do not close completely during ventricular contraction, i.e., the leaflets do not fully coapt. The cause of improper closure may be valve prolapse or other damage or structural changes to the leaflets, roots, tendon bands, or annulus of the valve. As a result, regurgitation through the valve 10 occurs during ventricular contraction. FIG. 1B shows leaflet 14 not reaching leaflet 12, while FIG. 1C shows the lip 17 of leaflet 14 swinging upward into atrium 6. If leaflets 12 and 14 cannot coapt, the valve 10 will not be effective in preventing the backflow of blood from the ventricle 8 into the atrium 6 during ventricular contraction.

[0165] Reference is now made to Figures 2A-F, 3A-F, 4A-F, 5A-F, and 6A-C, which are schematic illustrations of various variations of leaflet dilator 30 according to some applications. Figures 2A-F show dilator 30A, Figures 3A-F show dilator 30B, Figures 4A-F show dilator 30C, Figures 5A-F show dilator 30D, and Figures 6A-C show dilator 30E according to some applications. For example, exemplary variations of leaflet dilator 30 implanted in a heart are subsequently shown in Figures 7, 8, and 9A-B. It should be understood that dilator 30 of Figures 7, 8, and / or 9A-B may represent any one of the variations (30, 30A, 30B, 30C, 30D, or 30E) shown in Figures 2A-6C.

[0166] Each of the expanders 30A, 30B, 30C, and 30D includes panels 62 and 64, and expander 30E includes panels 32 and 34. In each variation, panels 62 and 64, or panels 32 and 34, are joined along one adjacent / parallel edge with an articulatable coupling 66. In the embodiment shown, each of the panels 62 and 64 has a substantially rectangular shape, and each of the panels 32 and 34 has a substantially oval shape. In the following description, references to panels 62 and 64 may be understood to apply to panels 32 and 34 as well.

[0167] Each of the panels 62 and 64 may include a flexible material. In some applications, each panel may have a single layer of flexible material. In some applications, the panels include a double layer of biocompatible woven or mesh webbing. The dimensions of the panels 62 and 64 may be provided according to the size of the valve and / or regurgitant portion of the valve that the expander 30 is intended to repair.

[0168] The articulatable coupling 66 between the panels 62 and 64 is such that the expander 30 is expandable by increasing the angular disposition between the panels and collapsible by decreasing the angular disposition. When the expander expands, the size of the opening 40 defined between the panels on opposite sides of the articulatable coupling increases, and when the expander collapses, the size of the opening decreases.

[0169] Each panel (e.g., its flexible material) may be imparted with cell growth modulating properties. In some applications, the fabric may have tissue growth promoting or inhibiting properties. In some such applications, one side of each panel may include a fabric having different properties than the fabric on the opposite side of the panel, and / or the fabric of one panel may have different properties than the fabric of the other panel.

[0170] 2A-B, 3A-B, 4A-B, 5A-B, and 6A show the dilator 30 (e.g., various embodiments thereof) in a state in which the panels 62 and 64 have a minimum angular separation therebetween, e.g., a folded state. In the folded state, the lip edges 63 may be adjacent to one another (even in contact with one another) and the dilator 30 may appear as substantially a single panel, e.g., the panels 62 and 64 may behave substantially as a single panel.

[0171] 2E-F, 3E-F, 4E-F, 5E-F, and 6C show the dilator 30, e.g., various embodiments thereof, with the panels 62 and 64 having a maximum angular separation therebetween, e.g., the maximum angular separation allowed by the configuration of the dilator. Expansion of the dilator may be limited by an articulatable coupling 66 or may be limited by a flexible connector (e.g., as described below).

[0172] 2C-D, 3C-D, 4C-D, 5C-D, and 6B, for example, show the expander 30 (eg, various embodiments thereof) in intermediate states in which the expander may transition between the collapsed state and the expanded state.

[0173] The coupling 66 between panels 62 and 64 may include, for example, a hinge, a stitch, a flexure, a metal formed in a particular configuration, such as Nitinol with a particular shape and memory, or other flexible stitching, or another means for articulably joining the two panels along an edge. The articulable coupling 66 may connect panels 62 and 64 along the entire length of the edge of each panel. In some cases, the panels are articulably joined along a partial length of the edge of each panel.

[0174] In some applications, the articulation connection may be biased such that the panels 62 and 64 have a predetermined angular arrangement therebetween, i.e., the coupling may be designed with a stiffness that, under stress-free conditions, tends to hold the two panels a predetermined distance apart. The expander 30 may be biased to fold by reducing the angular arrangement between the second panel and the first panel. The expander 30 may be biased to expand by increasing the angular arrangement between the second panel and the first panel. In some cases, the predetermined angular arrangement may be greater than 10 degrees and / or less than 120 degrees, e.g., between 10 and 120 degrees (e.g., between 20 and 90 degrees, e.g., between 20 and 60 degrees), i.e., such that the expander is biased to expand or open.

[0175] For example, a bias toward collapsing may be desirable if the valve is stenotic or the ventricle is small, e.g., to keep the effective valve orifice as open as possible during diastole (e.g., so that the dilator does not substantially impede blood flow during diastole). A bias toward dilation may be advantageous if coaptation is particularly difficult to achieve during dilation, e.g., if large gaps exist between the leaflets of the valve and / or the hemodynamic properties of the subject's heart are not optimal for the flow-inducing opening of the dilator. Thus, the advantages of using a dilator that is biased toward either collapsing or dilating may depend on factors such as the anatomical features and pathology of the valve and heart being treated.

[0176] In some applications, the first and second panels of dilator 30 may be substantially circular or elliptical in shape, as shown, for example, in panels 32 and 34 of dilator 30E. In some applications, the panels may be substantially rectangular in shape, as shown, for example, in panels 62 and 64 of dilators 30A, 30B, 30C, and 30D. Note that the scope of the present disclosure also includes panels of any other suitable shape.

[0177] The panels of any shape may include a flexible fabric or may include a plastic or flexible material, such as silicone or a polymer, that is shaped to define the first and second panels. Panels 62 and 64 may be sufficiently flexible to conform to the shape of the leaflets, i.e., the two panels may be shaped to conform to the contours of the leaflets of the valve, or may have different shapes. Panel 62 may be sized to overhang beyond the lip edge 15 of leaflet 12, for example, as further described in Figures 7, 8, and 9A-B below.

[0178] The panels 62 and 64 may be self-supporting so as not to require flexible connectors to restrict the opening 40. The panels 62 and 64 may be reinforced with a frame 72 (or a pair of frames), for example with metal inserts, strips of metal such as Nitinol, or metal wire. The frame may be woven onto or into the fabric of the panels. In some applications, the reinforcing mechanism may be metal threads or strips woven into the fabric.

[0179] In some applications, as shown, the frame 72 extends along one or more edges and / or lips of the panels. In some such applications, as shown, the frame 72 may extend across a central region of each panel between the coupling 66 and the lip 63, for example, such that the frame defines an H-shape. Each panel of the dilator 30 may include two layers of biocompatible fabric between or within which a wire loop is secured, the wire loop providing flexible rigidity to the panel.

[0180] The flexible fabric may define a first fabric layer disposed on a first side of the frame 72. The panel may further include a second fabric layer disposed on a second side of the frame 72 such that the frame is sandwiched between the first and second fabric layers. The fabric layers on each side of each panel may include the same or different types of fabric. The different types of fabric may differ, for example, in their tissue growth promoting properties.

[0181] The dilator 30 can include one or more anchors 38 configured to secure the panel 62 (and thereby the entire dilator) to the first leaflet 12 of the valve, as shown in Figures 7-9. For example, as described in more detail below, the anchors 38 can be configured to secure the panel 62 to the leaflet 12 (e.g., positioned relative to the panel 62) such that the articulatable coupling 66 is disposed closer to the root 13 than either the labrum edge 63 or the opening 40.

[0182] Anchor 38 may include, for example, a pin, a tissue piercing element, a T-bar, a thread, a clip, a suture, or a locking element.

[0183] In some applications, the anchors 38 may be provided and / or introduced separately and then attached to the panel 62 (e.g., during implantation of the expander 30). In some applications, the expander 30 may be provided with the anchors 38 pre-attached to the panel 62.

[0184] The location where the anchor 38 is attached to the panel 62 can be near the coupling 66, e.g., substantially at the coupling 66, closer to the coupling than the lip 63. The anchor 38 can be flexibly connected to the panel 62 such that the anchor is movable and can be oriented to penetrate the leaflets of the valve. In some cases, the anchor is a toggle anchor, with one end sharper than the other, i.e., having a sharp end that is used to penetrate the leaflets 12, and a blunt end. The anchor can be attached to the dilator, i.e., panel 62, via a flexible thread, string, or wire woven into the panel 62.

[0185] In some applications, panels 62 and 64 are substantially the same size and / or shape. In some applications, panel 64 is a different size (e.g., different length) than panel 62. For example, panel 64 may be larger (e.g., longer) than panel 64 such that panel 64 extends beyond lip edge 63 of panel 62, e.g., as described below with reference to FIG. 9A. In some applications, panel 62 may extend beyond lip edge 63 of panel 64.

[0186] 2A-2F show expander 30A, a variation of expander 30, for some applications. FIGS. 2A, 2C, and 2E show expander 30A in a sequence of conformations from closed (FIG. 2A) through partially open (FIG. 2C) to fully open (FIG. 2E) when viewed isometrically. FIGS. 2B, 2D, and 2F show the same sequence of conformations from closed to fully open when viewed in two dimensions from one side of the expander. In general, FIGS. 2A and 2B can be considered to represent the conformation of expander 30A during diastole (after the expander is implanted), and FIGS. 2E and 2F can be considered to represent its conformation during contraction.

[0187] 2A-F, the frame 72 functions to support and / or reinforce the panels 62 and 64, e.g., providing shape and strength. The frame 72 may be a single, integral frame that defines the articulable coupling 66, and generally, the frame 72 is referred to herein in the singular. However, in some applications, an individual frame may be provided for each panel of the expander 30, and these individual frames may be articulably coupled to one another at the coupling 66. It should be noted that in applications where a separate frame 72 is provided for each panel of the expander 30A, the frames are only coupled at the articulable coupling 66.

[0188] In contrast to applications 30B, 30C, and 30D shown in Figures 3A-F through 5A-F, respectively, dilator 30A lacks separate flexible connectors between panels 62 and 64 to limit angular expansion. Rather, frame 72 itself can provide a limiting function with respect to angular expansion of dilator 30A. In Figures 2A-2F, frame 72 is coupled only with articulatable coupling 66.

[0189] 3A-3F show expander 30B, a variation of expander 30, for some applications. FIGS. 3A, 3C, and 3E show expander 30B in a sequence of conformations from closed (FIG. 3A) through partially open (FIG. 3C) to fully open (FIG. 3E) when viewed isometrically. FIGS. 3B, 3D, and 3F show the same sequence of conformations from closed to fully open when viewed in two dimensions from one side of the expander. In general, FIGS. 3A and 3B can be considered to represent the conformation of expander 30B during diastole (after the expander is implanted), and FIGS. 3E and 3F can be considered to represent its conformation during contraction.

[0190] The dilator 30B further comprises a flexible connector 67, such as a string, thread, or wire. The connector 67 is attached to and between the lip 63 of the panel 62 and the lip 63 of the panel 64, opposite the articulated coupling 66. The connector 67 limits the angular disposition between the panels 62 and 64 to the extent of the opening 40. The connector 67 may be sized according to the desired maximum angular disposition between the panels 62 and 64, if necessary, to define the extent of the opening 40 when the device is in the open configuration.

[0191] The connectors 67 prevent the panels 64 from flapping wider than a predetermined or desired extent of the opening 40 during deflation. During diastole, when the panels 62 and 64 tend to fold toward each other, the connectors 67 can hang from the lip edges of the panels 62 and 64 rather than being under tension. In some applications, multiple connectors can be attached between the panels 62 and 64, e.g., one connector on each corner framing opening 40 or several connectors along the lip edges 63 of the panels 62 and 64. Similarly, in some applications, one or more connectors 67 can connect the sides 61 of the panels 62 and 64. Additionally, in some applications, one or more connectors 67 can connect other areas of the panels, e.g., the center of each panel (e.g., compared to the location of the connectors 67 in Figs. 3A-F near the articulatable coupling 66). The number and material composition of the connectors can depend on the desired strength of the connectors, which can also depend on the size and shape of the panels and, in some cases, on the type of articulation connection.

[0192] 4A-4F show expander 30C, a variation of expander 30, for some applications. Similar to FIGS. 2 and 3, FIGS. 4A, 4C, and 4E show expander 30C in a sequence of conformations from closed (FIGS. 4A, 4B) through partially open (FIGS. 4C, 4D) to fully open (FIGS. 4E, 4F) when viewed isometrically. FIGS. 4B, 4D, and 4F show the same sequence of conformations from closed to fully open when viewed in two dimensions from one side of the expander. In general, FIGS. 4A and 4B can be considered to represent the conformation of expander 30B during diastole (after the expander is implanted), and FIGS. 4E and 4F can be considered to represent its conformation during contraction.

[0193] In Figures 4A-F it is shown that the expander may further comprise a third panel 65 of flexible material. In addition to being flexible, the panel 65 may be highly permeable, i.e., allowing blood to flow therethrough. The third panel 65 may comprise a variety of flexible materials having openings or holes of a given size, such as a mesh fabric or a net of metal wires or woven threads. In some applications, the holes are sized to allow the free passage of blood therethrough. The panel 65 may comprise a tissue growth inhibitor.

[0194] A third panel 65 is disposed along and between the lip edges 63 of panels 62 and 64, typically connecting the edges of panels 62 and 64 opposite the articulation connection, spanning the opening 40. Panel 65 is attached to lip edges 63 of panels 62 and 64 opposite the hinge, providing a means for constraining the flap of the dilator to a predetermined angular opening. Panel 65 may thus be considered to be a flexible connector, functioning, for example, mutatis mutandis, similarly to flexible connector 67 described herein above. Panel 65 may be sized, if necessary, according to the maximum desired angular disposition between panels 62 and 64, defining opening 40 when the device is in an open configuration.

[0195] Alternatively or additionally, the panel 65 may be designed to interface with the second leaflet 14, providing support to the second leaflet and preventing it from flapping into the atrium during ventricular contraction (e.g., as described with reference to FIG. 8).

[0196] 5A-5F show expander 30D, a variation of expander 30, according to some applications. Figures 5A, 5C, and 5E show expander 30D in a sequence of conformations from closed (Figures 5A, 5B) through partially open (Figures 5C, 5D) to fully open (Figures 5E, 5F) when viewed isometrically. Figures 5B, 5D, and 5F show the same sequence of conformations from closed to fully open when viewed in two dimensions from one side of the expander. In general, Figures 5A and 5B can be considered to represent the conformation of expander 30D during diastole (after the expander is implanted), and Figures 5E and 5F can be considered to represent its conformation during contraction.

[0197] The expander 30D comprises panels 62 and 64 and an articulation joint 66. In some applications, the panels 62 and 64 are supported or their angular separation is constrained by one or more third panels 68, such as, for example, accordion folds, flexible fabric, netting, or other flexible sheets, connecting the sides of the panels 62 and 64. The panels 68 may be disposed perpendicular to the articulation joint 66. The panels or folds 68 provide stability to the expander and the frame opening 40 on the opposite side of the articulation joint. As shown in Figures 5A-5B, the accordion folds 68 are fully folded or folded (e.g., between panels 62 and 64) such that, when fully closed, the panels 62 and 64 are approximately adjacent. As in Figures 5E-5F, the extent of the opening 40 may be limited by the size of the folds or additional panels 68 on either side when fully open. Thus, the panels 68 may be considered to be flexible connectors, functioning similarly to, for example, the flexible connectors 67 described hereinabove, mutatis mutandis. Panel 68 may be sized as needed according to the desired maximum angular alignment between panels 62 and 64 to create opening 40 when the device is in an open configuration. In some applications, the folds include a flexible fabric that may collapse or expand outwardly upon folding or closing of dilator 30D.

[0198] 6A-6C show expander 30E, a variation of expander 30, for some applications. Expander 30E is shown in a sequence of configurations, when viewed isometrically, from closed (FIG. 6A), through partially open (FIG. 6B), to fully open (FIG. 6C). In general, FIG. 6A can be considered to represent the configuration of expander 30E during diastole (after the expander is implanted), and FIG. 6C can be considered to represent its configuration during contraction.

[0199] Dilator 30E has a shape with panels 32 and 34 having an oval (e.g., circular) outline, corresponding to panels 62 and 64 of applications 30A-30D. The panels are sewn together along one area to create articulation connection 36. As in Figures 2A-F through 5A-F, opening 40 can be a free space or an opening at lip edge 63 of panels 32 and 34. Dilator 30E can be self-supporting or can be folded or restrained at the dimensions of the angular opening by string, wire, netting, or side accordion folds, or any of the other mechanisms for the flexible connectors mentioned in the description of Figures 2-5. That is, the description of panels 62 and 64 also applies to panels 32 and 34. In applications involving flexible connectors, the connectors can be sized as needed according to the desired maximum angular placement between panels 32 and 34 to create opening 40 when the device is in an open configuration.

[0200] Panels 32 and 34 may include a flexible fabric. The fabric may be placed on and supported by a frame (not shown) that includes metal, plastic, or other material with bendable rigidity such that the frame supports the fabric. In some applications, each panel may have its own frame, with the individual frames articulably coupled to one another. In some applications, a single integral frame that extends between both panels and has articulation points may be used. Each panel may include two layers of fabric, sandwiching the frame therebetween. In some applications, the frame may be held within the two layers of fabric without being sewn directly to the panel itself (e.g., within each panel, the frame is restrained within a pocket defined by the two layers of fabric). In some applications, the frame may be sewn directly to the fabric.

[0201] Please refer to Figs. 7, 8, and 9A-B, which are schematic diagrams of the system 20 in which the expander 30 (e.g., a variation thereof) is implanted in the valve 10 according to some applications. The system applications may be used to treat cases of valve dysfunction, such as prolapse, regurgitation, or flail leaflets. The expander 30 may be fixed to the leaflet 12, or in some applications, to the leaflet 14. In some applications, the expander 30 is fixed to the incompetent leaflet. In some applications, the expander 30 is fixed to the healthy leaflet (e.g., opposite the incompetent leaflet). In some applications, a respective expander 30 is fixed to each of the leaflets. In each figure, the upper image represents the valve 10 of the heart 4 during contraction, and the lower image represents the valve during expansion. These notations also apply to Fig. 11, described below, for the expander 130.

[0202] Although the following description refers to panels 62 and 64, the description is equally applicable, mutatis mutandis, to the variation of expander 30 that includes panels 32 and 34.

[0203] 7 shows the system 20 after the dilator 30 has been transluminally advanced into the heart 4 and the panels 62 have been secured to the leaflets 12 using anchors 38. The dilator 30 can be any one of dilators 30A, 30B, 30C, 30D, or 30E from FIGS. 2A-F through 6A-C, or a combination of these variations.

[0204] The dilator 30 is configured to be secured to the leaflet 12, such as via an anchor 38, as shown in Figs. 7, 8, and 9A-B. The dilator 30 may be secured to either a healthy leaflet (e.g., as shown in Fig. 7) or a dysfunctional leaflet (e.g., as shown in Fig. 8). Although the dilator 30 is shown secured to the leaflet 12 in each of Figs. 7, 8, and 9A-B, different clinical scenarios are illustrated and described in these figures. That is, in some applications, the dilator may be secured to the more severely or most dysfunctional leaflet, and in some cases, the leaflet opposite the leaflet having dysfunctional performance. Which leaflet the dilator is secured to depends on the performance of the valve during contraction, and which leaflet, or scallops or segments of that leaflet, may have the greatest need for reinforcement. In some applications, multiple dilators may be used to treat a given valve.

[0205] Anchors 38 are used to connect the panels 62 to the leaflets 12. In some applications, as shown, the anchoring is such that the articulatable coupling 66 is disposed between the root 13 and labial edge 15 of the leaflet, i.e., closer to the root than the labial edge. In some applications, the dilator 30 may be secured such that the articulatable coupling 66 is disposed at the annulus of the valve 10. In some applications, the dilator 30 may be sized such that the panels 62 cover a majority of the leaflets 12. In some applications, the dilator 30 may cover only the area of ​​the leaflet 12 near the labial edge 15 and / or may cover only one scallop of the leaflet.

[0206] In some applications, the first and second panels are the same size and shape (e.g., as shown above). In some applications, either panel may be larger in at least one dimension than the other, such that, for example, lip 63 of panel 64 opposite the hinge extends beyond lip 63 opposite panel 62, as shown in Figures 9A-B.

[0207] The panel 62 may be flush with the surface of the first leaflet 12 and may comprise a material configured (e.g., sufficiently flexible) to follow the contours of the first leaflet. In some cases, the first panel conforms to the changing morphology of the first leaflet as it opens and closes during diastole and systole.

[0208] In some applications, the expander 30 is provided with anchors 38 pre-attached to the panel 62, for example as shown.

[0209] In some applications, anchor 38 is provided as a separate element that is introduced during implantation (e.g., coupled to panel 64). The anchor is designed to be attached or coupled to the first panel generally near articulatable coupling 66, or at least closer to the articulatable coupling than labrum 63.

[0210] In FIG. 7, a system 20 is shown for treating a valve 10 of a subject's heart 4, the valve having a malfunction, e.g., as shown in FIG. 1B, where leaflet 14 does not normally coapt with leaflet 12. Dilator 30 bridges a potential gap between leaflets 12 and 14 during systole, such that leaflet 14 contacts panel 64 of dilator 30. Dilator 30 is in an open or expanded configuration during systole, such that opening 40 faces ventricle 8, panel 62 is attached to leaflet 12, and panel 64 coapts with leaflet 14. During ventricular diastole, shown in the bottom image of FIG. 7, as leaflets 12 and 14 separate (allowing blood into ventricle 8), panels 62 and 64 of dilator 30 fold towards each other, minimizing the opening between them, thereby reducing blockage of blood flow through valve 10 (e.g., compared to when the dilator remains in its expanded state).

[0211] FIG. 8 shows a dilator 30C implanted such that the third panel 65 is positioned against the leaflet 14 during at least ventricular contraction. The opening 40 faces the ventricle 8, for example, during both ventricular systole and diastole. The panel 64 of the dilator 30 coapts with the upstream surface of the leaflet 14 during ventricular contraction, depicted in the top image of FIG. 8. Coaptation closes the opening between the leaflet 12 and the leaflet 14, preventing backflow of blood from the ventricle 8 into the atrium 6. During ventricular diastole, depicted in the bottom image of FIG. 8, as the leaflets 12 and 14 separate (allowing blood into the ventricle 8), the panels 62 and 64 of the dilator 30 fold toward each other, minimizing the opening therebetween, thereby reducing obstruction of blood flow through the valve 10 (e.g., compared to when the dilator remains in its expanded state).

[0212] Reference is now made to Figures 9A and 9B, which illustrate additional and distinct features present in some applications. The expander 30 may further comprise a tether 70 made of metal wire, suture, textile thread, or other connecting filament configured to anchor the panel 62 to ventricular tissue 80. The tether 70 is coupled to and extends from the panel 62 and is attached to the ventricular tissue 80 via a ventricular anchor 74, while the anchor 38 secures the panel 62 to the leaflets 12. The anchor 74 may secure the tether 70 to a papillary muscle, ventricular wall, ventricular interspace, or other tissue of the ventricle. The tether 70 may be attached to the lip 63 of the panel 62, or elsewhere on the panel 62.

[0213] In some applications, the tether is hypothesized to advantageously stabilize the dilator by regulating the movement of the first panel 32 relative to the first leaflet 12, providing additional support to the dilator. The tether may be used to stabilize or further secure the dilator in place, for example, in the case of a torn tendon. The tether 70 is configured to increase the efficiency of the valve leaflet dilator in preventing backflow through the valve.

[0214] Reference is now made to Figures 10A-C and 11, which are schematic illustrations of a leaflet dilator 130 according to some applications. Figure 10A illustrates a variation 130A of the dilator 130, and Figures 10B-C illustrate a variation 130B.

[0215] The dilator 130 includes three panels 52, 54, and 56 disposed about an axis 82 (e.g., a central axis) of the dilator. In some applications (e.g., as shown in FIG. 10B), each panel defines a respective plane 84 that is substantially parallel to the axis 82. In some applications, each panel may be somewhat curved (e.g., as shown in FIG. 10C). Each panel may be substantially circular or elliptical in shape. In some applications, each panel may be substantially rectangular in shape. The panels may include a cell proliferation inducer. The panels may include a cell proliferation inhibitor. Anchors 58 are used to secure the panels 52 to the leaflets of the valve. The anchors 58 may be coupled to the panels 52 closer to the edges of the panels than to the axis 82 of the dilator.

[0216] Variation 130A illustrates that in some applications, panels 52, 54, and 56 may be distributed at angles of 120 degrees about axis 82 and / or diverge at angles of 120 degrees from one another. Variation 130B illustrates that in some applications, two of the panels are oriented closer to one another, for example, such that the angle between panels 54 and 56 is greater than 120 degrees. In FIG. 10C, expander 130B is shown substantially facing such that axis 82 extends through the two-dimensional surface of the image, i.e., in and out of the plane of the page or surface on which the image is drawn.

[0217] In some applications, one or more aspects of the variations of expander 30 (e.g., panel composition, panel size, panel shape, panel reinforcement, and panel anchoring) can be applied to expander 130. For example, the composition, support, and stiffness of panels 52, 54, and 56 can be similar to the composition, support, and stiffness of panels 62 / 32 and 64 / 34, mutatis mutandis. In some applications, expander 130 can include a plastic or flexible material, such as a silicone or polymer, that is shaped to define a first panel, a second panel, and a third panel. The material properties of the material can allow the panels to be folded or pressed together for delivery.

[0218] In some applications, the expander 130 lacks a hinge mechanism, such that the expander essentially retains its three-dimensional shape after implantation during both diastole and systole. Nevertheless, the expander 130 can be configured to be compressed for transluminal delivery, e.g., with two or more of its panels closer to one another (e.g., in contact with one another), and automatically assume the configuration shown upon deployment in the heart.

[0219] In FIG. 11, a schematic diagram of a system 120 according to some applications is shown, showing a dilator 130 implanted in a heart. A first panel 52 is secured to a first leaflet 12 by at least one anchor 58. The anchor 58 may be as described for the anchor 38, mutatis mutandis. The anchor 58 may be coupled to the panel 52 closer to an edge of the panel than the axis 82 of the dilator. When the first panel 52 is secured to the first leaflet 12, it may or may not conform to the shape of the leaflet. In some applications, the panel 52 may be secured closer to the root 13 of the leaflet 12. When the panel 52 is secured to the leaflet 12, the panels 54 and 56 maintain a substantially parallel relationship with the axis 82.

[0220] The panel 52 may be secured to the leaflet 12 such that the panel 56 extends into the ventricle 8, e.g., toward the overhanging leaflet 12. In some cases, a portion of the panel 56 contacts the leaflet 12.

[0221] The top image of FIG. 11 represents the valve 10 of the heart 4 during contraction, and the bottom image represents the valve during expansion. Features described in FIGS. 7, 8, and 9A-B may be incorporated into the application shown in FIG. 11. A dilator 130 may be attached to the leaflet 12, or in some applications, to the leaflet 14. Either the leaflet 12 or the leaflet 14 may be a healthy leaflet or a dysfunctional leaflet. The dilator 130 bridges a potential gap between the leaflets 12 and 14 such that the panel 54 and / or panel 56 coapts with the leaflet 14 during contraction.

[0222] In some applications, panels 54 and 56 collectively define a surface such that after panel 52 is anchored to leaflet 12, the surface is presented as a coaptation surface to leaflet 14 during ventricular contraction.

[0223] Anchor 58 may be configured to secure panel 52 to leaflet 12 such that panel 56 is disposed within ventricle 8 and panel 54 is disposed within atrium 6 during ventricular systole, e.g., panel 54 extends within atrium 6, away from leaflet 12 and across an upstream surface of leaflet 14. Thus, during ventricular systole, panel 54 may be disposed against the upstream surface of leaflet 14. In some cases, lip edge 17 of leaflet 14 contacts panel 56 during ventricular systole. During ventricular diastole, both panel 56 and panel 54 are typically disposed in ventricle 8.

[0224] System 120 may further comprise a tether (not shown, as in Figs. 9A-B) coupled to and extending from panel 52 or panel 56, for example, and configured to connect the panel to ventricular tissue of the heart. The system / apparatus may further comprise a ventricular anchor coupled to the tether and configured to secure the tether to the ventricular tissue. The ventricular tissue may be, for example, tissue of the ventricular wall or tissue of the papillary muscles. The ventricular anchor may be coupled to the tether in a manner that facilitates adjustment of the tension of the tether. A winch may be used to couple the ventricular anchor to the tether such that the tension of the tether is adjustable by actuation of the winch. The tether is configured to increase the efficiency of the valve leaflet dilators in preventing regurgitation through the valve.

[0225] The system 120 may further include a delivery tool for delivering the expander 130 to the heart 4. The delivery tool may secure the first panel to the first leaflet while the second and third panels are disposed within the delivery tool. The second and third panels may then be deployed from the delivery tool.

[0226] Referring again to Figures 1A-11, several possible advantages of the design shown in the present application may be identified. The dilator 30, 130 requires attachment to only the leaflets of a single valve. The design lends itself to the possibility of adapting or scaling the size of the dilator to the optimal size and shape of the valve being treated. In addition to being suitable for valves with incomplete coaptation, the application of the present system may be applicable to the treatment of mitral annular calcification treatment, since it does not require contraction of the annulus. Some applications of the dilator 30, 130 may have advantages in transluminal insertion, since the design allows the panels to be shorter or smaller than a comparable single panel patch. Although optional tethers are described herein above, it is assumed that in some applications, the dilators described herein advantageously do not require a ventricular tether.

[0227] The above-described systems, devices, and techniques may be used in combination with those described in one or more of the following references, each of which is incorporated herein by reference in its entirety. For example, the techniques described in one or more of the following references, each of which is incorporated herein by reference for all purposes, for attachment to ventricular tissue and / or valve leaflets and / or for adjusting tension of tethers (e.g., artificial tendons), may be used in combination with one or more of the devices and techniques described herein. Similarly, any of the expanders described herein may be used as a component of an implant (e.g., as a "patch" or "upstream assembly" of an implant) described in any of the following references. PCT International Publication No. 2022 / 101817 by Tennenbaum et al. U.S. Provisional Patent Application No. 63 / 11 3,430, filed November 13, 2020, by Tennenbaum et al. U.S. Patent No. 9,277,994 to Miller et al. U.S. Patent No. 9,180,007 to Reich et al.

[0228] The various systems, devices, instruments, etc. of the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the methods described herein may include such sterilization of the associated systems, devices, instruments, etc. Additionally, the scope of the present disclosure includes, for some applications, sterilizing any one or more of the various systems, devices, instruments, etc. of the present disclosure.

[0229] Any of the techniques, methods, operations, steps, etc. described or suggested herein may be performed on live animals (e.g., humans, other mammals, etc.) or may be performed on non-biological simulations, such as cadavers, cadaver hearts, anthropomorphic phantoms, and / or simulator devices (which may include electronic and / or physical representations of body parts, tissues, etc.).

[0230] Although some operations of the disclosed methods are described in a particular sequential order for convenience of presentation, it should be understood that the described method encompasses rearrangements, unless a particular order is required by specific language described below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various aspects in which the disclosed systems, devices, apparatus, methods, etc. may be used in combination with other systems, devices, apparatus, methods, etc. EXAMPLES

[0231] Example Applications (Some non-limiting examples of the concepts herein are listed below):

[0232] Example 1. 1. A system or device comprising a dilator for a first leaflet of a heart valve, the first leaflet having a labrum, the valve having a second leaflet and an annulus, the valve being disposed between an atrium and a ventricle of the heart, a root of the first leaflet attached to the annulus, the dilator comprising: (A) a first panel; and (B) a second panel articulably coupled to the first panel by an articulable coupling, such that the dilator is (i) expandable by increasing an angular disposition between the first panel and the second panel, thereby increasing a dimension of an opening defined between the first panel and the second panel on an opposite side of the articulable coupling, and (ii) collapsible by decreasing the angular disposition.

[0233] Example 2. The system / apparatus described in Example 1, wherein the expander further comprises an anchor coupled to the first panel and configured to secure the first panel to the first leaflet, such that (i) the first panel is positioned against the first leaflet and (ii) the articulatable coupling is positioned closer to the root than the labrum and the orifice.

[0234] Example 3. The system / device of any one of Examples 1-2, wherein the anchor is configured to secure the first panel to the first leaflet such that the expander expands during ventricular contraction and collapses during ventricular expansion.

[0235] Example 4. The system / device of any one of Examples 1-3, wherein the anchor is configured to secure the first panel to the first leaflet with the opening facing the ventricle.

[0236] Example 5. The system / apparatus of any one of Examples 1-4, further comprising a flexible connector connected to the first panel and the second panel in a manner that limits the expansion of the expander by limiting the angular arrangement between the first panel and the second panel.

[0237] Example 6. The system / device of any one of Examples 1-5, wherein the anchor is coupled to the first panel closer to the articulatable coupling than the lip edge of the first panel.

[0238] Example 7. The system / apparatus of any one of Examples 1-6, wherein each of the first panel and the second panel is substantially circular or elliptical in shape.

[0239] Example 8. The system / apparatus of any one of Examples 1-7, wherein each of the first panel and the second panel is substantially rectangular in shape.

[0240] Example 9. The system / device of any one of Examples 1-8, wherein the first panel is sufficiently flexible to conform to the shape of the first leaflet.

[0241] Example 10. A system / device described in any one of Examples 1-9, wherein the first panel is dimensioned such that fixing the first panel to the first leaflet by the anchor causes the first leaflet to extend beyond the lip edge of the first leaflet.

[0242] Example 11. The system / apparatus of any one of Examples 1-10, wherein the second panel is articulably connected to the first panel along the entire length of each panel's edge.

[0243] Example 12. The system / apparatus of any one of Examples 1-11, wherein the second panel is articulably coupled to the first panel along a partial length of an edge of each panel.

[0244] Example 13. The system / apparatus of any one of Examples 1-12, wherein the articulatable coupling comprises a stitch.

[0245] Example 14. The system / apparatus of any one of Examples 1-13, wherein the articulatable coupling comprises a hinge.

[0246] Example 15. The system / apparatus of any one of Examples 1-14, wherein the articulatable coupling comprises a flexure.

[0247] Example 16. The system / apparatus of any one of Examples 1-15, wherein the anchor comprises a clip.

[0248] Example 17. The system / device of any one of Examples 1-16, wherein the anchor comprises a tissue-piercing element.

[0249] Example 18. The system / device described in any one of Examples 1-17, wherein the expander is configured such that fixing the first panel to the first valve leaflet by the anchor increases the efficiency of the valve in inhibiting backflow of blood through the valve during ventricular contraction.

[0250] Example 19. A system / device described in any one of Examples 1-18, wherein the first panel is dimensioned such that when the first panel is secured to the first leaflet by the anchor, the first panel extends beyond the lip edge of the first leaflet.

[0251] Example 20. The system / apparatus of any one of Examples 1-19, wherein the second panel is sized to extend beyond an edge of the first panel.

[0252] Example 21. The system / device of any one of Examples 1-20, wherein the first leaflet is a fluttering leaflet and the expander is configured to be secured to the fluttering first leaflet such that the second panel interfaces with the second leaflet, thereby inhibiting fluttering of the first leaflet.

[0253] Example 22. The system / device described in any one of Examples 1-21, wherein the second leaflet is a fluttering leaflet and the expander is configured to be secured to the first leaflet such that the second panel interfaces with the fluttering second leaflet, thereby inhibiting flutter of the second leaflet.

[0254] Example 23. A system / device described in any one of Examples 1-22, wherein the expander is configured such that expansion of the expander reduces backflow of blood through the valve while the first panel is secured to the first valve leaflet by the anchor.

[0255] Example 24. The system / device of any one of Examples 1-23, wherein the expander comprises a polymer that is shaped to define a first panel and a second panel.

[0256] Example 25. The system / device of any one of Examples 1-24, wherein the expander comprises silicone shaped to define the first panel and the second panel.

[0257] Example 26. The system / device described in any one of Examples 1-25, further comprising a tether coupled to the first panel, extending therefrom, and configured to be attached to ventricular tissue while the anchor secures the first panel to the first leaflet.

[0258] Example 27. The system / device described in Example 26, wherein the anchor is a leaflet anchor, and the system / device further includes a ventricular anchor coupled to the tether and configured to secure the tether to ventricular tissue while the leaflet anchor secures the first panel to the first leaflet.

[0259] Example 28. The system / device of Example 26, wherein the ventricular tissue is ventricular wall tissue.

[0260] Example 29. The system / device of Example 26, wherein the ventricular tissue is papillary muscle tissue.

[0261] Example 30. The system / device described in Example 26, wherein the ventricular anchor is coupled to the tether in a manner that facilitates adjustment of the tension of the tether.

[0262] Example 31. The system / apparatus described in Example 30, further comprising a winch coupled to the ventricular anchor, the anchor being coupled to the tether via the winch such that the tension of the tether is adjustable by actuation of the winch.

[0263] Example 32. The system / apparatus of any one of Examples 1-31, wherein at least a first panel comprises a cell proliferation-inducing material.

[0264] Example 33. The system / apparatus of Example 32, wherein the second panel comprises a cell proliferation-inducing material.

[0265] Example 34. The system / device of Example 32, wherein the second panel is formed from a cell growth inhibitory material.

[0266] Example 35. The system / device of any one of Examples 1-34, wherein the first panel and the second panel each comprise a flexible fabric.

[0267] Example 36. The system / device of Example 35, wherein the expander further comprises at least one frame.

[0268] Example 37. The system / apparatus of Example 36, wherein at least one frame serves to reinforce the fabric.

[0269] Example 38. The system / apparatus of Example 36, wherein the fabric of each of the first panel and the second panel is disposed on at least one frame such that the at least one frame supports the fabric.

[0270] Example 39. The system / apparatus of Example 36, wherein at least one frame is shaped to define a hoop.

[0271] Example 40. The system / apparatus of Example 36, wherein at least one frame has an H-shape defining a crossbar, the crossbar of the H transverse to the face of the panel.

[0272] Example 41. The system / apparatus of Example 36, wherein at least one frame is positioned along at least one edge of each panel.

[0273] Example 42. The system / apparatus of Example 36, wherein the at least one frame includes a first frame and a second frame, and the first frame is articulably coupled to the second frame.

[0274] Example 43. The system / device of Example 36, wherein at least one frame comprises a single, integral frame having an articulation connection portion at which the second panel is articulably connected to the first panel.

[0275] Example 44. The system / device of Example 43, wherein the integral frame comprises a resilient material that biases the first panel and the second panel into a predetermined angular position therebetween.

[0276] Example 45. The system / device of Example 43, wherein the one-piece frame comprises an elastic material that defines a flex connection between the first panel and the second panel.

[0277] Example 46. The system / device of Example 36, wherein at least one frame is sewn to the fabric.

[0278] Example 47. The system / apparatus of Example 36, wherein for each of the first panel and the second panel, (i) the flexible fabric defines a first fabric layer disposed over a first side of the at least one frame, and (ii) the panel further includes a second fabric layer disposed over a second side of the at least one frame such that the frame is sandwiched between the first fabric layer and the second fabric layer.

[0279] Example 48. The system / apparatus of Example 36, wherein the at least one frame and the fabric are dimensioned relative to each other such that the at least one frame and the fabric are pre-tensioned.

[0280] Example 49. The system / apparatus of Example 48, wherein the at least one frame provides a particular form and shape to the panel when the textile is placed over the at least one frame.

[0281] Example 50. The system / device of any one of Examples 1-49, wherein the expander is biased toward the first panel and the second panel and has a predetermined angular arrangement therebetween.

[0282] Example 51. The system / device of Example 50, wherein the expander is biased to collapse by reducing the angular arrangement between the second panel and the first panel.

[0283] Example 52. The system / device of Example 50, wherein the expander is biased to expand by increasing the angular alignment between the second panel and the first panel.

[0284] Example 53. A system / apparatus as described in any one of Examples 1-52, wherein (A) the first panel has (i) a lip edge opposite the articulatable coupling and (ii) a lateral edge extending between the articulatable coupling and the lip edge of the first panel, (B) the second panel has (i) a lip edge opposite the articulatable coupling and (ii) a lateral edge extending between the articulatable coupling and the lip edge of the second panel, and (C) the opening is defined by the lip edge of the first panel and the lip edge of the second panel.

[0285] Example 54. The system / apparatus described in Example 53, further comprising a flexible connector connected to the first panel and the second panel in a manner that limits the expansion of the expander by limiting the angular arrangement between the first panel and the second panel.

[0286] Example 55. The system / apparatus of Example 54, wherein the flexible connector is located on an opposite side of the articulatable coupling extending between the first panel and the second panel.

[0287] Example 56. The system / device of Example 55, wherein the flexible connector connects the lip edge of the first panel and the lip edge of the second panel.

[0288] Example 57. The system / device of Example 56, wherein the flexible connector connects a substantially central portion of the lip edge of the first panel to a substantially central portion of the lip edge of the second panel.

[0289] Example 58. The system / apparatus described in Example 56, wherein (A) the flexible connector is a first flexible connector, (B) the expander further comprises a second flexible connector, (C) the first flexible connector connects a first side portion of the lip edge of the first panel to a first side portion of the lip edge of the second panel, and (D) the second flexible connector connects a second side portion of the lip edge of the first panel substantially opposite the first side portion of the lip edge of the first panel to a second side portion of the lip edge of the second panel substantially opposite the first side portion of the lip edge of the second panel.

[0290] Example 59. The system / device of Example 55, wherein the flexible connector connects (i) a portion on the first panel midway between the articulatable coupling and the lip edge of the first panel, and (ii) a portion on the second panel midway between the articulatable coupling and the lip edge of the second panel.

[0291] Example 60. The system / device of Example 54, wherein the flexible connector connects the side edge of the first panel to the side edge of the second panel.

[0292] Example 61. The system / device of Example 54, wherein the flexible connector includes a flexible third panel extending between the first panel and the second panel.

[0293] Example 62. The system / apparatus of Example 54, wherein the flexible connector comprises a cell growth inhibitor.

[0294] Example 63. The system / apparatus of Example 54, wherein the flexible connector comprises a cell growth promoting substance.

[0295] Example 64. The system / device of Example 61, wherein a flexible third panel connects the lip edge of the first panel to the lip edge of the second panel.

[0296] Example 65. The system / device of Example 61, wherein the third panel comprises at least one of a fabric and a net.

[0297] Example 66. The system / device of Example 61, wherein the anchor is configured to secure the first panel to the first leaflet such that the third panel joins with the second leaflet during contraction.

[0298] Example 67. The system / device of Example 61, wherein the anchor is configured to secure the first panel to the first leaflet so that the third panel faces the ventricle during contraction.

[0299] Example 68. (i) the lateral edge of the first panel is a first lateral edge of the first panel, (ii) the lateral edge of the second panel is a first lateral edge of the second panel that is substantially aligned with the first lateral edge of the first panel, (iii) the first panel has a second lateral edge substantially opposite the first lateral edge of the first panel and extending between the articulatable coupling and a lip edge of the first panel, and (iv) the second panel is substantially aligned with the first lateral edge of the second panel. The system / apparatus of Example 61, wherein (i) the third panel has a second lateral edge extending between the articulatable coupling and the lip edge of the second panel opposite the first lateral edge and substantially aligned with the second lateral edge of the first panel, (v) the third panel extends between the first lateral edge of the first panel and the first lateral edge of the second panel, and (vi) the expander further comprises a flexible fourth panel extending between the second lateral edge of the first panel and the second lateral edge of the second panel.

[0300] Example 69. The system / device of Example 68, wherein the third panel and the fourth panel have folds configured to fold inward when the opening is folded.

[0301] Example 70. The system / device of Example 54, wherein the flexible connector comprises at least one connector element selected from the group consisting of wires and threads.

[0302] Example 71. The system / apparatus of Example 71, wherein the flexible connector comprises exactly one connector element selected from the group.

[0303] Example 72. The system / device of Example 53, wherein the anchor is coupled to the first panel closer to the articulatable coupling than the lip edge of the first panel.

[0304] Example 73. The system / apparatus of any one of Examples 1-72, wherein the anchor comprises a toggle anchor.

[0305] Example 74. The system / device described in Example 73, wherein the toggle anchor has a blunt end and a sharp end and is configured to be advanced through the first leaflet from the sharp end.

[0306] Example 75. The system / device of Example 73, wherein the anchor is attached to the first panel by a flexible yarn.

[0307] Example 76. The system / device of Example 73, wherein the anchor is a first anchor and the expander further comprises a second anchor coupled to the first panel and configured to secure the first panel to the first leaflet.

[0308] Example 77. The system / apparatus of Example 73, wherein the first anchor includes a first toggle anchor and the second anchor includes a second toggle anchor.

[0309] Example 78. The system / device of any one of Examples 1-77, wherein the expander is configured such that (i) the first panel is secured to the first leaflet, and (ii) the articulatable coupling is positioned closer to the root than the lip and the opening, while blood flow through the heart transitions the expander toward its expanded configuration during ventricular contraction and toward its folded configuration during ventricular expansion.

[0310] Example 79. The system / device described in Example 78, further comprising a flexible connector connected to the first panel and the second panel in a manner that limits expansion of the expander during ventricular contraction.

[0311] Example 80. The system / apparatus of any one of Examples 1-79, wherein the system / apparatus is sterilized.

[0312] Example 81. 1. A system or device comprising: a dilator for a first leaflet of a heart valve, the first leaflet having a lip, the valve being positioned between an atrium and a ventricle of the heart and having a second leaflet, the system or device comprising: (A) a first panel; (B) a second panel; (C) a third panel; and (D) an anchor, each of the panels (i) having a respective outer edge; (ii) extending inwardly from the outer edge such that the first, second, and third panels converge at an axis of the dilator; and (iii) defining a panel plane substantially parallel to the axis, the anchor configured to secure the first panel to the first leaflet.

[0313] Example 82. The system / device of Example 81, wherein the system / device is sterilized.

[0314] Example 83. The system / device of any one of Examples 81-82, wherein the expander comprises a polymer shaped to define a first panel, a second panel, and a third panel.

[0315] Example 84. The system / device of any one of Examples 81-83, wherein the expander comprises silicone shaped to define a first panel, a second panel, and a third panel.

[0316] Example 85. The system / device of any one of Examples 81-84, wherein the anchor is configured to attach the first panel to the first leaflet such that the second panel extends away from the first panel toward the second leaflet.

[0317] Example 86. The system / device of any one of Examples 81-85, wherein the anchor is configured to secure the first panel to the first leaflet such that the third panel extends away from the first panel toward the ventricle.

[0318] Example 87. The system / device of any one of Examples 81-86, wherein the anchor is coupled to the first panel closer to the edge of the first panel than the axis of the expander.

[0319] Example 88. The system / device of any one of Examples 81-87, wherein each of the first panel, the second panel, and the third panel is substantially circular or elliptical in shape.

[0320] Example 89. The system / apparatus of any one of Examples 81-88, wherein each of the first panel, the second panel, and the third panel is substantially rectangular in shape.

[0321] Example 90. The system / device described in any one of Examples 81-89, wherein the first panel is sufficiently flexible to conform to the shape of the first leaflet.

[0322] Example 91. The system / device of any one of Examples 81-90, wherein the first panel is dimensioned such that fixing the first panel to the first leaflet by the anchor causes the third panel to extend beyond the lip edge of the first leaflet.

[0323] Example 92. The system / device of any one of Examples 81-91, wherein (A) the second panel and the third panel collectively define a surface, and (B) the anchor is configured to secure the first panel to the first leaflet such that (i) the first panel is positioned relative to the first leaflet, and (ii) the surface is presented as a coaptation surface to the second leaflet.

[0324] Example 93. The system / device of Example 92, wherein the anchor is configured to secure the first panel to the first leaflet such that the third panel is positioned within the ventricle.

[0325] Example 94. The system / device of Example 92, wherein the anchor is configured to secure the first panel to the first leaflet such that during ventricular contraction, the second panel extends into the atrium, away from the first panel, and across the upstream surface of the second leaflet.

[0326] Example 95. The system / device of Example 92, wherein the anchor is configured to secure the first panel to the first leaflet such that during ventricular contraction, the second panel is positioned against the upstream surface of the second leaflet.

[0327] Example 96. The system / device of Example 92, wherein the anchor is configured to secure the first panel to the first leaflet such that the lip edge of the second leaflet contacts the third panel during ventricular contraction.

[0328] Example 97. The system / device described in any one of Examples 81-96, further comprising a tether coupled to the first panel, extending therefrom, and configured to anchor the first panel to ventricular tissue of the heart.

[0329] Example 98. The system / device described in Example 97, wherein the anchor is a leaflet anchor, and the system / device further includes a ventricular anchor coupled to the tether and configured to secure the tether to ventricular tissue while the leaflet anchor secures the first panel to the first leaflet.

[0330] Example 99. The system / device of Example 97, wherein the ventricular tissue is ventricular wall tissue.

[0331] Example 100. The system / device of Example 97, wherein the ventricular tissue is papillary muscle tissue.

[0332] Example 101. The system / device described in Example 97, wherein the ventricular anchor is coupled to the tether in a manner that facilitates adjustment of the tension of the tether.

[0333] Example 102. The system / apparatus described in Example 97, further comprising a winch coupled to the ventricular anchor, the anchor being coupled to the tether via the winch such that the tension of the tether is adjustable by actuation of the winch.

[0334] Example 103. The system / apparatus of any one of Examples 81-102, wherein at least the first panel comprises a cell proliferation-inducing material.

[0335] Example 104. The system / device of Example 103, wherein the second panel comprises a cell proliferation-inducing material.

[0336] Example 105. The system / device described in Example 103, wherein the third panel comprises a cell proliferation-inducing material.

[0337] Example 106. The system / device of Example 103, wherein the second panel comprises a cell proliferation inhibitory material.

[0338] Example 107. The system / device of Example 103, wherein the third panel comprises a cell proliferation inhibitory material.

[0339] Example 108. The system / device of any one of Examples 81-107, wherein each of the first panel, the second panel, and the third panel comprises a flexible fabric.

[0340] Example 109. The system / apparatus of Example 108, wherein the expander further comprises a frame.

[0341] Example 110. The system / apparatus of Example 109, wherein the frame serves to strengthen the fabric.

[0342] Example 111. The system / apparatus of Example 109, wherein the fabric of each of the first panel, the second panel, and the third panel is placed on a frame such that the frame supports the fabric.

[0343] Example 112. The system / apparatus of Example 109, wherein for each of the first, second, and third panels, the frame extends along an outer edge of the panel substantially parallel to the axis.

[0344] Example 113. The system / apparatus of Example 109, wherein the frame comprises a single integral frame that defines the contours of the first panel, the second panel, and the third panel.

[0345] Example 114. The system / device of Example 109, wherein the integral frame comprises an elastic material that biases the first panel, the second panel, and the third panel into a predetermined angular position relative to one another.

[0346] Example 115. The system / device of Example 109, wherein the integral frame comprises an elastic material.

[0347] Example 116. The system / device of Example 109, wherein the frame is sewn to the fabric.

[0348] Example 117. The system / apparatus of Example 109, wherein for each of the first panel, the second panel, and the third panel, (i) the flexible fabric defines a first fabric layer disposed over a first side of the frame, and (ii) the panel further includes a second fabric layer disposed over a second side of the frame such that the frame is sandwiched between the first fabric layer and the second fabric layer.

[0349] Example 118. The system / apparatus of Example 109, wherein the frame and fabric are sized relative to each other so that the frame and fabric are pre-tensioned.

[0350] Example 119. The system / apparatus of Example 109, wherein when the fabric is placed on the frame, the frame provides a particular form and shape to the first panel, the second panel, and the third panel.

[0351] Example 120. 1. A method for use with a simulated valve in a simulated heart, the simulated valve having a first leaflet and a second leaflet, and positioned between an atrium and a ventricle of the heart, the method comprising: (A) transluminally advancing a dilator into the simulated heart, the dilator comprising: (i) a first panel, (ii) a second panel articulably coupled to the first panel, and (iii) an anchor; and (B) securing the first panel to the first leaflet using the anchor, such that (i) the first panel of the dilator is positioned against the first leaflet and (ii) the second panel responsive to blood flow in the simulated heart: (a) deflects away from the first panel toward the second leaflet during ventricular contraction, and (b) deflects away from the second leaflet toward the first panel during ventricular expansion.

[0352] Example 121. The method of Example 120, wherein fixing the first panel to the first valve leaflet includes fixing the first panel to the first valve leaflet such that the second panel coapts with the second valve leaflet during ventricular contraction in response to blood flow in the heart, thereby reducing regurgitation through the simulated valve.

[0353] Example 122. 122. The method of any one of Examples 120-121, wherein deflection of the second panel during ventricular contraction causes the second panel to coapt with the second leaflet.

[0354] Example 123. The method of any one of Examples 120-122, further comprising anchoring the first panel to ventricular tissue using a tether connected to the first panel.

[0355] Example 124. The method of any one of Examples 120 to 123, further comprising adjusting the tension of the tether.

[0356] Example 125. The method of any one of Examples 120 to 124, wherein anchoring the first panel to the ventricular tissue includes fixing the tether to the ventricular tissue using a tissue anchor attached to the tether.

[0357] Example 126. The method of any one of Examples 120 to 125, further comprising coupling the tissue anchor to the tether via a winch.

[0358] Example 127. 127. The method of any one of examples 120-126, further comprising adjusting tension in the tether by actuating a winch.

[0359] Example 128. 128. The method of any one of Examples 120-127, further comprising attaching a flexible third panel between the first panel and the second panel.

[0360] Example 129. The method of any one of Examples 120-128, wherein deflection of the second panel during ventricular contraction accompanies coaptation of the flexible third panel with the second leaflet.

[0361] Example 130. 1. A method for use with a simulated valve in a simulated heart, the simulated valve having a first leaflet and a second leaflet and being positioned between an atrium and a ventricle of the heart, the method comprising: (A) transluminally advancing a dilator into the simulated heart, the dilator comprising: (i) a first panel, (ii) a second panel, (iii) a third panel, and (iv) an anchor; and (B) securing the first panel to the first leaflet, each of the panels (i) having a respective outer edge and (ii) extending inwardly from the outer edge such that the first, second, and third panels converge at an axis of the dilator and (iii) define respective panel planes substantially parallel to the axis.

[0362] Example 131. The method of Example 130, wherein (i) fixing the first panel to the first leaflet comprises fixing the first panel to the first leaflet while the second panel and the third panel are disposed within a delivery tool, and (ii) thereafter, further comprising deploying the second panel and the third panel from the delivery tool.

[0363] Example 132. The method of any one of Examples 130 to 131, wherein deploying the second panel and the third panel from the delivery tool includes deploying the second panel and the third panel from the delivery tool such that the second panel and the third panel are deflected away from each other.

[0364] Example 133. 1. A system or device comprising a leaflet dilator for use with a heart valve, the valve having at least a first leaflet and a second leaflet, the system or device comprising: (i) a first panel and a second panel articulably connected to the first panel; and (ii) a tissue-piercing element coupled to the first panel and configured to secure the first panel to the first leaflet, such that during ventricular contraction, closure of the valve involves articulation of the second panel away from the first panel and toward the second leaflet.

Claims

1. 1. An apparatus comprising a dilator for a first leaflet of a heart valve, the first leaflet having a lip, the valve having a second leaflet and an annulus, the valve being disposed between an atrium and a ventricle of the heart, the root of the first leaflet being attached to the annulus, and the dilator comprising: The first panel; a second panel articulably coupled to the first panel by an articulable coupling, such that the expander comprises: expandable by increasing the angular alignment between the first panel and the second panel, thereby increasing a size of an opening defined between the first panel and the second panel on opposite sides of the articulatable coupling; a second panel that is foldable by reducing the angular configuration; and an anchor coupled to the first panel and configured to secure the first panel to the first leaflet, such that: the first panel is positioned relative to the first leaflet; the articulatable coupling is positioned closer to the root than the labrum and the opening; and an anchor.

2. The device of claim 1 , wherein the device is sterilized.

3. 3. The device of claim 1, wherein the anchor is configured to secure the first panel to the first leaflet such that the expander expands during ventricular contraction and collapses during ventricular expansion.

4. The device of any one of claims 1 to 3, wherein the anchor is configured to secure the first panel to the first leaflet such that the opening faces the ventricle.

5. 5. The device of claim 1, further comprising a flexible connector connected to the first panel and the second panel in a manner that limits the angular arrangement between the first panel and the second panel, thereby limiting the expansion of the expander.

6. The apparatus of any one of claims 1 to 5, wherein the anchor is coupled to the first panel closer to the articulatable coupling than a lip edge of the first panel.

7. The apparatus of any one of claims 1 to 6, wherein each of the first panel and the second panel is substantially circular or elliptical in shape.

8. The apparatus of any one of claims 1 to 7, wherein each of the first panel and the second panel is substantially rectangular in shape.

9. The device of any one of claims 1 to 8, wherein the first panel is sufficiently flexible to conform to a shape of the first leaflet.

10. 10. The device of claim 1, wherein the first panel is dimensioned such that securing the first panel to the first leaflet by the anchor causes the first leaflet to overhang beyond the lip edge of the first leaflet.

11. An apparatus according to any preceding claim, wherein the second panel is articulably connected to the first panel along the entire length of each panel's edge.

12. An apparatus as claimed in any preceding claim, wherein the second panel is articulably connected to the first panel along a partial length of an edge of each panel.

13. An apparatus according to any preceding claim, wherein the articulatable coupling comprises a stitch.

14. An apparatus according to any preceding claim, wherein the articulatable coupling comprises a hinge.

15. An apparatus according to any preceding claim, wherein the articulatable coupling comprises a flexure.

16. The device of any one of claims 1 to 15, wherein the anchor comprises a clip.

17. The device of any one of claims 1 to 16, wherein the anchor comprises a tissue-piercing element.

18. 18. The device of any one of claims 1 to 17, wherein the expander is configured such that fixing the first panel to the first leaflet by the anchor increases the efficiency of the valve to inhibit backflow of blood through the valve during ventricular contraction.

19. 19. The device of any one of claims 1 to 18, wherein the first panel is sized such that when the anchor secures the first panel to the first leaflet, the first panel extends beyond the lip edge of the first leaflet.

20. An apparatus according to any preceding claim, wherein the second panel is dimensioned to extend beyond an edge of the first panel.

21. 21. The device of any one of claims 1 to 20, wherein the first leaflet is a fluttering leaflet and the dilator is configured to be secured to the fluttering first leaflet such that the second panel coapts with the second leaflet, thereby inhibiting flutter of the first leaflet.

22. 22. The device of any one of claims 1 to 21, wherein the second leaflet is a fluttering leaflet and the dilator is configured to be secured to the first leaflet such that the second panel coapts with the fluttering second leaflet, thereby inhibiting flutter of the second leaflet.

23. 23. The device of any one of claims 1 to 22, wherein the expander is configured such that expansion of the expander reduces backflow of blood through the valve while the first panel is secured to the first leaflet by the anchor.

24. The device of any one of claims 1 to 23, wherein the expander comprises a polymer that is shaped to define the first panel and the second panel.

25. The device of any one of claims 1 to 24, wherein the expander comprises silicone shaped to define the first panel and the second panel.

26. 26. The device of any one of claims 1-25, further comprising a tether coupled to and extending from the first panel and configured to be attached to ventricular tissue while the anchor secures the first panel to the first leaflet.

27. 27. The device of claim 26, wherein the anchor is a leaflet anchor, the device further comprising a ventricular anchor coupled to the tether and configured to secure the tether to the ventricular tissue while the leaflet anchor secures the first panel to the first leaflet.

28. 27. The apparatus of claim 26, wherein the ventricular tissue is tissue of a wall of the ventricle.

29. 27. The apparatus of claim 26, wherein the ventricular tissue is papillary muscle tissue.

30. 27. The device of claim 26, wherein the ventricular anchor is coupled to the tether in a manner that facilitates adjustment of the tension in the tether.

31. 31. The apparatus of claim 30, further comprising a winch coupled to the ventricular anchor, the anchor being coupled to the tether via the winch such that the tension in the tether is adjustable by actuation of the winch.

32. The device of any one of claims 1 to 31, wherein at least the first panel comprises a cell proliferation inducing material.

33. 33. The device of claim 32, wherein the second panel comprises a cell proliferation-inducing material.

34. 33. The device of claim 32, wherein the second panel is formed from a cell growth inhibitory material.

35. The apparatus of any one of claims 1 to 34, wherein the first panel and the second panel each comprise a flexible fabric.

36. 36. The device of claim 35, wherein the expander further comprises at least one frame.

37. 37. The apparatus of claim 36, wherein the at least one frame serves to reinforce the fabric.

38. 37. The apparatus of claim 36, wherein the fabric of each of the first panel and the second panel is disposed on the at least one frame such that the at least one frame supports the fabric.

39. 37. The apparatus of claim 36, wherein the at least one frame is shaped to define a hoop.

40. 37. The apparatus of claim 36, wherein the at least one frame has an H-shape defining a crossbar, the crossbar of the H transverse to a face of the panel.

41. 37. The apparatus of claim 36, wherein the at least one frame is positioned along at least one edge of each panel.

42. 37. The apparatus of claim 36, wherein the at least one frame includes a first frame and a second frame, the first frame being articulably coupled to the second frame.

43. 37. The apparatus of claim 36, wherein the at least one frame comprises a single, unitary frame having an articulation location at which the second panel is articulably coupled to the first panel.

44. 44. The apparatus of claim 43, wherein the unitary frame includes a resilient material that biases the first panel and the second panel into a predetermined angular orientation therebetween.

45. 44. The apparatus of claim 43, wherein the unitary frame includes a resilient material defining a flex connection between the first panel and the second panel.

46. 37. The device of claim 36, wherein the at least one frame is sewn to the fabric.

47. For each of the first panel and the second panel, the flexible fabric defines a first fabric layer disposed on a first side of the at least one frame; 37. The apparatus of claim 36, wherein the panel further includes a second fabric layer disposed on a second side of the at least one frame such that the frame is sandwiched between the first and second fabric layers.

48. 37. The apparatus of claim 36, wherein the at least one frame and the fabric are dimensioned relative to one another such that the at least one frame and the fabric are pre-tensioned.

49. 49. The apparatus of claim 48, wherein the at least one frame provides a particular form and shape to the panel when the fabric is placed over the at least one frame.

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