Systems and methods for heart valve leaflet repair

Abstract

A system (100) for use with a subject heart valve (10) includes an anchor (30) and an implant (200) including wings (220) having a contact surface (222) and an opposing surface (223) opposite the contact surface. The wings define a tip portion (232), a root portion (230), and a bending element (280q) connecting the tip portion to the root portion. The implant includes an interface (250) at the root portion of the wing. The system includes a delivery tool (150) including a catheter (140) transluminally advanceable into the heart and a shaft (160) disposed within the catheter and engaging the interface of the implant. Other embodiments are also described.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to: U.S. Provisional Application No. 63 / 387,498 to Amin et al., filed December 14, 2022, entitled "Systems and methods for heart valve leaflet repair"; U.S. Provisional Application No. 63 / 497,194 to Amin et al., filed April 19, 2023, entitled "Systems and methods for heart valve leaflet repair," and U.S. Provisional Application No. 63 / 507,068 to Amin et al., filed June 8, 2023, entitled "Systems and methods for heart valve leaflet repair."

[0002] Each of the above documents is incorporated herein by reference in its entirety for all purposes. [Background technology]

[0003] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform a critical function in ensuring the forward flow of blood properly delivered through the cardiovascular system. These heart valves can be rendered less effective by congenital malformations, inflammatory processes, infections, or disease. Such damage to the valves can lead to serious cardiovascular problems or even death. Treatment of such problems can be performed by surgically repairing or replacing the valves during open-heart surgery or by transcatheter transvascular techniques, which introduce and implant prosthetic devices in a much less invasive manner than open-heart surgery.

[0004] A healthy heart has an overall conical shape tapering from the apex to the base. The heart has four chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve in the human heart connects the left atrium and the left ventricle. The mitral valve includes an annulus, a ring-shaped portion of natural valve tissue surrounding the mitral valve opening, and a pair of leaflets (also called cusps) extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D" shape, an ellipse, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet can be larger than the posterior leaflet, and when they occlude together, they form an overall "C"-shaped boundary between the abutting free edges of the leaflets.

[0005] When functioning properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricular muscle relaxes, the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts, increased blood pressure in the left ventricle presses the two leaflets together, causing the one-way mitral valve to close. As a result, blood cannot flow back into the left atrium and instead is expelled from the left ventricle through the aortic valve. To prevent the leaflets from slipping off or swinging under pressure and from folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether each leaflet to the papillary muscles of the left ventricle.

[0006] Valve regurgitation occurs when the native valves fail to close properly during the systolic phase of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Valve regurgitation (particularly mitral valve regurgitation) is the most common form of valvular heart disease. Mitral valve regurgitation has various causes, including valve leaflet prolapse or flailiness, restricted valve leaflet movement (e.g., due to leaflet stiffness / calcification), and / or insufficient papillary muscle compliance. Summary of the Invention [Problem to be solved by the invention]

[0007] There is a continuing need for effective devices and methods for treating valve problems, including flail and prolapsed leaflets and restricted leaflet movement. [Means for solving the problem]

[0008] This Summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any feature included in the Examples of this Summary is not required by a claim unless the claim explicitly recites that feature. Also, features, components, steps, concepts, etc. described in the Examples of this Summary and elsewhere in this disclosure can be combined in various manners. Various features and steps described elsewhere in this disclosure can be included in the Examples summarized here.

[0009] In some implementations, a system is provided for use with a real or simulated heart valve, such as a mitral or tricuspid valve. In some implementations, a delivery tool including a shaft is advanced transluminally through a catheter, while the shaft engages an interface, such as via a ripcord extending through both the shaft and a portion of the interface. In some implementations, the shaft can be used to deploy an implant, which extends from the catheter.

[0010] In some such implementations, the implant is self-expandable and can expand to an expanded state when the implant is advanced from a catheter.

[0011] In some such implementations, the implant is mechanically expandable and can be actuated to expand to an expanded state as or after the implant is advanced from the catheter.

[0012] In some implementations, the system includes an implant including wings and an interface (e.g., an anchor receiving member, etc.). In some implementations, the delivery tool is reversibly engaged to the implant via the interface. In some implementations, the shaft defines a latch that reversibly engages the shaft to the interface.

[0013] In some implementations, the delivery tool includes a driver that is used to anchor the anchor through the interface and into the tissue site, hi some implementations, the driver extends through a distal end portion of the shaft and into the interface.

[0014] In some implementations, the anchor includes a helical tissue-engaging element extending from the anchor head. Alternatively or additionally, the anchor includes a shape-memory material that changes shape and / or defines barbs that expand when the anchor is released from compression.

[0015] In some implementations, the implant includes an anchor receiving member that is separate from the interface. In some implementations, for example, when a delivery tool is coupled to the implant interface, a driver extends through a lateral opening in the shaft into the anchor receiving member. In some implementations, the anchor is advanced through the interface and the face of the tissue along a curved path within the tissue, whereby a distal portion of the anchor is guided out of the tissue and received in the anchor receiving member.

[0016] In some implementations, the interface is located at a root portion of the wing, and the wing extends from the root portion of the wing to the tip portion of the wing.

[0017] In some implementations, the expansion element aids in expanding the wings and / or helps keep the wings expanded.

[0018] In some implementations, the shaft is used to position the implant relative to the interface at the tissue site so that the wings extend over the leaflets of the valve and toward the opposing leaflets of the valve.

[0019] In some implementations, the wings include a frame covered by a flexible sheet, for example, the sheet can define lateral flaps that extend laterally beyond the frame so that the lateral flaps extend into the commissures of the native valve.

[0020] In some implementations, the interface is a ratcheting interface that allows a user to pull the driver and anchor proximally relative to the interface to facilitate abutment of the implant against the tissue site.

[0021] In some implementations, the shaft branches into two branches, with corresponding drivers extending through the branches to corresponding interfaces, and in some implementations, each corresponding driver can be operated simultaneously or individually, for example, via a controller.

[0022] In some implementations, each interface extends diagonally from the wing, which can facilitate interaction between a pair of anchors and a pair of interfaces as the anchors are threaded (e.g., along non-parallel axes) into their respective tissue sites. For example, each shaft branch can be angled side-by-side to reduce the risk of "shadowing" artifacts caused by the shaft when visualizing the implant, e.g., using an imaging device pointing the wings orthogonally.

[0023] In some implementations, the implant can be configured to facilitate tissue ingrowth at the anchor receiving member and to prevent tissue ingrowth at the tip portions of the wings, thereby facilitating upstream and downstream deflection of the wings in response to the cardiac cycle.

[0024] In some implementations, the wings provide resistance to upstream deflection of the leaflets when the interface is anchored to the site.

[0025] In some implementations, the wings provide greater resistance to upstream deflection of the root portion of the leaflet while allowing the lip portion of the leaflet to behave more flexibly. For example, the root portion of the wing can include a stiffer material and / or have a more densely packed support member arrangement compared to the tip portion of the wing.

[0026] In some implementations, the wings include bending elements that facilitate movement of the tip portions of the wings relative to the root portions of the wings during the cardiac cycle. In some implementations, the bending elements bias the tip portions to deflect into the ventricle and away from the opposing leaflets of the valve. For example, the bending elements can transition away from a relaxed state (e.g., to a tense state) as the heart progresses through systole and toward a relaxed state as the heart progresses through diastole.

[0027] In some implementations, the bending element is a hinge, facilitating articulation of the tip portion of the wing relative to the root portion of the wing. In this way, the root portion of the wing (optionally stiffer than the tip portion), anchored directly to the site, can provide greater support to the portion of the leaflet experiencing prolapse, while articulation of the tip portion relative to the root portion can improve coaptation of the swinging portion of the leaflet.

[0028] In some implementations, the wings provide dynamic support to the leaflets during the cardiac cycle, ie, when the leaflets reach and / or pass their upstream deflection limits, the wings provide greater resistance to upstream deflection of the leaflets.

[0029] In some implementations, the limbs or extensions coupled to the wings extend away from the wings so that the limbs / extensions contact tissue adjacent to the roots of the opposing leaflets of the heart when the roots of the wings are positioned against the annulus. By contacting the tissue, the limbs / extensions mitigate upstream deflection of the wings. In some implementations, the limbs / extensions are legs that contact ventricular tissue, such as the underside of the valve, for example, adjacent the commissures of the valve and / or adjacent the subannular groove.

[0030] In some implementations, a pair of arms are coupled to the wing, and in some implementations, each arm arcs divergently away from the wing toward its anchor point, such that when the anchor point is anchored to the annulus, each arm arcs from the anchor point, along the annulus, to the wing, e.g., the arms thereby define an annular support.

[0031] In some such implementations, the arms are connected to the wings by hinge connections that allow the wings to articulate relative to the annular support when the wings are compressed, and expansion of the wings constrains the hinge connections, thereby preventing articulation.

[0032] In some implementations, a hinge connects each arm to a wing, and the hinge articulates in response to deflection of the wing, helping to maintain the root portion of the wing in contact with the annulus during the cardiac cycle.

[0033] In some implementations, a pair of arms extend laterally away from the tip portion of the wing to define a lateral portion of each arm.

[0034] In some implementations, the implant is implanted such that the lateral portions of the arms abut corresponding lateral portions on the downstream surface of the leaflet, pressing the leaflet in an upstream direction. In some implementations, the lateral portions of the arms abut medial portions of the upstream surface of the leaflet, pressing the wings, thereby sandwiching the leaflet between the wings and the lateral portions of the arms.

[0035] In some implementations, the implant includes a limiter that limits the upstream deflection of the wings and leaflets, for example, by limiting the range of motion of a hinge connecting the tip portion to the root portion. In some implementations, the limiter can contact the implant (e.g., an interface and / or a portion of the wing) when the wing reaches its deflection limit.

[0036] In some implementations, the restrictor includes a rear catch extending away from the wings and the interface, for example, the rear catch can be wider than the wings to increase stability of the restrictor and / or can be anchored to cardiac tissue.

[0037] In some implementations, the deflection limit of the wing can be adjusted by adjusting the limiter, for example, by pressing a posterior catch of the limiter against the annulus tissue. In some implementations, the limiter is adjusted by adjusting the depth to which the anchor is anchored into the tissue and / or by adjusting the angle of the limiter relative to the interface.

[0038] In some implementations, the interface itself is adjustable, and adjusting the interface adjusts the deflection limits of the wing, for example by changing the angle between the interface and the root portion of the wing.

[0039] In some implementations, the limiter includes a tether that is tensioned when the wing reaches a deflection limit, which in some implementations is adjustable by adjusting the length of the tether.

[0040] In some implementations, the wing can limit its own deflection. In some implementations, the frame of the wing can provide greater resistance to the wing deflecting upstream (e.g., beyond a deflection limit) compared to the wing deflecting downstream. For example, the frame can define a notch that widens when the wing deflects downstream and closes when the wing deflects upstream, thereby preventing the wing from deflecting upstream beyond the deflection limit.

[0041] In some implementations, the implant is adjustable in size, and in some implementations, actuation of the bulking elements changes the bulkiness of at least a portion of the implant (e.g., the tip, middle, or end portions of the wings, etc.).

[0042] In some implementations, the wings are adjustable in size, and in some implementations, a shape memory member is coupled to the wings, and heating (e.g., electrically heating) the shape memory member changes its shape, thereby changing the size of the wings.

[0043] In some implementations, the wings are adjustable in shape, in some implementations a beam is connected to the wing and a line is bonded to the beam so that applying tension to the line causes the beam to tighten, thereby reshaping the wing.

[0044] In some implementations, the implant includes a locking member that locks the wings so that they retain their new size even after heating of the shape memory member has ceased.

[0045] In some implementations, the delivery tool includes a locking member having multiple units that are unlockable to allow the units to translate apart. In some such implementations, when the locking member is unlocked, a tether connects the units of the locking member, and the locking member is relocked, for example, by applying tension to the tether.

[0046] In some implementations, the wings are slidable relative to the anchor (e.g., slidable within the heart using an adjustment rod) and / or pivotable relative to the anchor. In some implementations, the anchor receiving member defines an oval opening, and the wings are slidable along a longitudinal axis of the opening. In some implementations, after sliding the wings relative to the anchor and / or allowing the wings to pivot relative to the anchor, the implant is locked to the anchor, for example, by sandwiching the anchor receiving member between a first collar and a second collar of the interface.

[0047] According to some implementations, a system and / or device (e.g., for use with a cardiac valve of a live subject or a simulation, the valve having an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet) includes an anchor, an implant, and / or a delivery tool. The implant can include, among other components, wings and / or interfaces. The wings can be configured to define a first surface (e.g., a contact surface) and a second surface (e.g., an opposing surface, a surface opposite the first surface, etc.).

[0048] In some implementations, the anchor includes an anchor head and a tissue-engaging element extending from the anchor head, hi some implementations, the outer diameter of the anchor head is greater than the outer diameter of the tissue-engaging element.

[0049] In some implementations, the wings can have a root portion and a tip portion, and a bending element connecting the tip portion to the root portion.

[0050] In some implementations, the interface can be coupled to a root portion of the wing, can be configured to receive an anchor, and / or can be configured to be anchored by an anchor.

[0051] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter is transluminally advanceable into the heart chamber.

[0052] In some implementations, the shaft can engage with the interface and / or can be configured to (i) deploy the implant from the catheter and / or (ii) position the implant in place via engagement with the interface.

[0053] In some implementations, in position, the interface can be located upstream of the valve and / or the wings can extend over the first leaflet toward the opposing leaflet, with the first surface, or contact surface, facing the first leaflet.

[0054] In some implementations, the driver can be configured to engage an anchor and / or to secure the implant in place using the anchor, thereby anchoring the interface to cardiac tissue at the site.

[0055] In some implementations, the implant is sterilized, in some implementations, the anchor is sterilized, and in some implementations, the delivery tool is sterilized.

[0056] In some implementations, the bending element protrudes from the first or contact surface of the wing.

[0057] In some implementations, the bending element protrudes from a second or opposite surface of the wing.

[0058] In some implementations, the flexure element is a flexure member.

[0059] In some implementations, the flexure element is a hinge.

[0060] In some implementations, the flexure element is a living hinge.

[0061] In some implementations, the bending element includes a pair of interlocking loops, a first loop of the pair of interlocking loops defined by a root portion and a second loop of the pair of interlocking loops defined by a tip portion.

[0062] In some implementations, the bending element includes multiple coiled wires connecting the tip portion to the root portion.

[0063] In some implementations, the bending element includes multiple rings connecting the tip portion to the root portion.

[0064] In some implementations, the bending element includes a plurality of sutures connecting the tip portion to the root portion.

[0065] In some implementations, the bending element includes a tube through which corresponding distal and proximal portions extend alongside one another, thereby allowing the distal and proximal portions to articulate relative to one another.

[0066] In some implementations, the root portion is stiffer than the tip portion.

[0067] In some implementations, the implant is configured such that when the implant is secured in place, the bending element bends to facilitate deflection of the tip portion relative to the base portion in response to the cardiac cycle of the heart.

[0068] In some implementations, the bending element protrudes and the implant is configured such that when the implant is secured in place, the bending element abuts a hinge point between the valve leaflets and the valve annulus.

[0069] In some implementations, the bending element protrudes to abut against a hinge point between the valve leaflets and the valve annulus, and the bending element is positioned within the implant such that the abutment of the bending element against the hinge point positions the interface at the site.

[0070] In some implementations, the bending element protrudes and the shaft is configured to position the interface at the site by abutting the bending element against a hinge point between the valve leaflets and the valve annulus.

[0071] In some implementations, the wing includes a frame and a flexible sheet disposed over the frame, and / or the frame defines a flexure element.

[0072] In some implementations, the flexure element is a torsion spring.

[0073] In some implementations, the flexure element is a hinge.

[0074] In some implementations, the flexure element is a ball-and-socket hinge.

[0075] In some implementations, the flexibility of the delivery tool shaft can be adjusted to mitigate the possibility of deflection of the wings when the implant is anchored to the tissue, and in some implementations, the shaft can support the tissue through an interface, thereby affecting the function of the valve.

[0076] In some implementations, increasing the flexibility of the shaft can compensate for the support it provides, making it easier to assess the impact of the implant on valve function while the shaft remains engaged against the interface.

[0077] In some implementations, the anchor and interface are configured to prevent a gap from developing between the tissue and the interface, and in some implementations, a portion of the torque transmitted by the driver to the anchor head is translated into a distal pushing force on the anchor receiving member.

[0078] In some implementations, when the anchor head is fully seated within the interface, further rotation of the anchor moves the anchor proximally, away from the interface.

[0079] In some implementations, the anchor and the interface are configured to prevent non-helical advancement of the anchor distally through the interface, thereby preventing a gap from opening between the tissue and the interface.

[0080] In some implementations, the anchor head is rotatably coupled to the interface while the anchor head remains longitudinally fixed relative to the interface, hi some implementations, the interface facilitates non-helical withdrawal of the anchor proximally through the interface.

[0081] In some implementations, the interface includes a locking body configured to allow the tissue engaging element of the anchor to thread through the locking body and configured to stop the helical advancement of the anchor when the anchor head reaches the locking body.

[0082] According to some implementations, the system and / or device (e.g., for use with a cardiac valve of a live subject or a simulation, the valve having a valve annulus, a first leaflet, and an opposing leaflet opposite the first leaflet) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant can include, among other components, an interface, a first wing, and a second wing.

[0083] In some implementations, the first wing can extend from a first root portion of the first wing to a first tip portion of the first wing and can define a first surface (e.g., a contact surface) and a second surface (e.g., an opposing surface, a surface opposite the first surface, etc.).

[0084] In some implementations, the second wing can extend over a second or opposite surface of the first wing from a second root portion of the second wing to a second tip portion of the second wing, thereby allowing the first wing to be deflected toward and away from the second wing.

[0085] In some implementations, the interface is coupled to the first root portion and the second root portion.

[0086] In some implementations, the interface is configured to receive an anchor and / or be configured to be anchored to a site within a heart chamber.

[0087] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter is transluminally advanceable into the heart chamber.

[0088] In some implementations, the shaft can engage with the interface and / or can be configured to (i) deploy the implant from the catheter and / or (ii) position the implant in place via engagement with the interface.

[0089] In some implementations, in position, the interface can be located at a location upstream of the valve, the first wing can extend over the first leaflet toward the opposing leaflet with the first surface / contact surface facing the first leaflet, and / or the second wing can extend over the second surface / opposite surface of the first wing.

[0090] In some implementations, the driver can be configured to engage an anchor and / or to secure the implant in place using the anchor, thereby anchoring the interface to cardiac tissue at the site.

[0091] In some implementations, the implant is sterilized, in some implementations, the anchor is sterilized, and in some implementations, the delivery tool is sterilized.

[0092] In some implementations, the implant is configured such that the first wing deflects away from the second wing during ventricular diastole when the implant remains fixed in place.

[0093] In some implementations, the implant further includes a third wing having a third root portion coupled to the interface and extending over the second wing from the third root portion to a third tip portion of the third wing, the second wing being deflectable toward and away from the third wing.

[0094] In some implementations, the third wing is shorter than the second wing.

[0095] In some implementations, the second wing is more flexible than the third wing.

[0096] In some implementations, the first wing is more flexible than the second wing.

[0097] In some implementations, the implant is configured such that the second wing deflects away from the third wing during ventricular diastole when the implant remains fixed in place.

[0098] In some implementations, the implant is configured such that the first wing deflects away from the second wing during ventricular diastole when the implant remains fixed in place.

[0099] In some implementations, the implant is configured such that the first wing deflects into contact with the second wing during ventricular systole when the implant remains fixed in place.

[0100] In some implementations, the implant is configured such that the second wing deflects into contact with the third wing during ventricular systole when the implant remains fixed in place.

[0101] In some implementations, the first wing defines a plurality of holes therethrough.

[0102] In some implementations, the implant is configured such that, when the implant remains fixed in place, during ventricular systole, the first wing deflects to contact the second wing in a manner that obstructs blood flow through the hole.

[0103] In some implementations, the second wing defines a plurality of holes therethrough, the holes in the first wing being positioned such that the holes in the first wing are offset relative to the holes in the second wing when the first wing is in contact with the second wing.

[0104] In some implementations, the second wing is stiffer than the first wing.

[0105] In some implementations, the second wing is shorter than the first wing.

[0106] In some implementations, the implant further includes a flexible pouch, the first wing and the second wing being disposed within the pouch.

[0107] In some implementations, the pouch is configured to expand during ventricular diastole and to contract during ventricular systole.

[0108] In some implementations, the pouch is coupled to the interface.

[0109] In some implementations, on a first face of the pouch, the pouch defines a plurality of first pouch face holes that provide fluid communication between the interior and exterior of the pouch.

[0110] In some implementations, on a second surface of the pouch opposite the first surface, the pouch defines a plurality of second pouch surface holes that provide fluid communication between the interior and exterior of the pouch.

[0111] In some implementations, the pouch is configured such that when the implant is secured in place, the first side of the pouch moves toward the second side of the pouch in a manner that blocks blood flow through the first pouch side hole and the second pouch side hole when the first wing deflects toward the second wing during ventricular systole.

[0112] In some implementations, each of the first and second wings is stiffer than the pouch.

[0113] In some implementations, the first pouch face hole and the second pouch face hole are positioned such that when the implant is secured in place and the first wing is deflected toward the second wing, the first pouch face hole is offset relative to the second pouch face hole.

[0114] According to some implementations, the system and / or device (e.g., for use with a cardiac valve of a live subject or a simulation, the valve having an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet) includes an implant. In some implementations, the implant can include, among other components, wings, an interface, and / or a restrictor.

[0115] In some implementations, the wings may have a root portion and / or a tip portion and may define a first surface (e.g., a contact surface) and a second surface (e.g., an opposite surface, a surface opposite the first surface, etc.).

[0116] In some implementations, the interface is coupled to a root portion of the wing. In some implementations, the interface can be configured to receive an anchor.

[0117] In some implementations, the interface can be configured to be anchored to a site within a heart chamber such that the implant is fixed in place with the wings extending over the first leaflet toward the opposing leaflet and deflecting upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0118] In some implementations, the restrictor is configured to define a deflection limit for the wing and to provide a counter force when the wing reaches the deflection limit to prevent the wing from deflecting upstream beyond the deflection limit.

[0119] In some implementations, the implant is sterilized.

[0120] In some implementations, the implant is configured so that the wings contact the limiter when they reach their deflection limit.

[0121] In some implementations, the limiter includes a tether configured to be tensioned when the wing reaches a deflection limit.

[0122] In some implementations, the restrictor is coupled to the interface such that the interface is deflectable toward and away from the restrictor.

[0123] In some implementations, the implant is configured such that the interface contacts the limiter when the wing reaches its deflection limit.

[0124] In some implementations, the restrictor is coupled to the interface and extends away from the interface and over the wings such that the wings are deflectable toward and away from the restrictor.

[0125] In some implementations, the restrictor is stiffer than the wing.

[0126] In some implementations, the deflection limit is defined by the relative position between the restrictor and the wing.

[0127] In some implementations, the restrictor extends away from the interface and over a second surface of the wing, i.e., over the opposite surface of the wing, and the wing is deflectable toward the restrictor such that the wing contacts the restrictor when the deflection limit is reached.

[0128] In some implementations, the restrictor is shaped so that the wing contacts the restrictor at a contact portion of the wing located between the root portion of the wing and the tip portion of the wing.

[0129] In some implementations, the limiter is shaped to define a cross brace that contacts the wing spanwise against the wing when the wing reaches its deflection limit.

[0130] In some implementations, the wing is a first wing and the restrictor includes a second wing.

[0131] In some implementations, the second wing is shorter than the first wing.

[0132] In some implementations, the second wing is narrower than the first wing.

[0133] In some implementations, the restrictor has a rear catch that is configured to press against tissue of the heart chamber when anchoring the interface to the site.

[0134] In some implementations, the system / device further includes an anchor, and / or the rear locking portion defines an anchor receiving member, the anchor receiving member configured to receive the anchor in a manner that anchors the anchor receiving member to tissue of the heart chamber.

[0135] In some implementations, the rear catch is wider than the wings.

[0136] In some implementations, the rear catch extends from the interface away from the wing.

[0137] In some implementations, the restrictor is shaped to define a cross-brace along the width of the restrictor that can be configured to compress against tissue of the heart chamber upon anchoring of the interface to the site.

[0138] In some implementations, the restrictor includes a frame, the frame including a first portion including or formed from sheet metal, and / or a second portion coupled to the first portion and including or formed from wire.

[0139] In some implementations, the first portion is shaped to define a plurality of adjacent cells.

[0140] In some implementations, the wire includes or is formed from a shape memory alloy.

[0141] In some implementations, the second portion is more flexible than the first portion.

[0142] In some implementations, the implant is configured so that the interface approaches the limiter as the wings approach their deflection limits.

[0143] In some implementations, the implant is configured such that the interface contacts the limiter when the wing reaches its deflection limit.

[0144] In some implementations, the limiter is shaped to define a cradle such that when the wing reaches its deflection limit, the interface temporarily seats within the cradle.

[0145] In some implementations, the implant includes a spring configured to tension as the interface approaches the restrictor.

[0146] In some implementations, the implant includes a spring configured to bias the interface away from the restrictor.

[0147] In some implementations, the restrictor extends from the interface away from the wing.

[0148] In some implementations, the restrictor is located on the opposite side of the interface from the wing.

[0149] In some implementations, the restrictor is shaped to anchor the interface to the site, thereby pressing the restrictor against the tissue of the heart chamber.

[0150] According to some implementations, a system and / or device (e.g., for use with a cardiac valve of a live subject or a simulation, the valve having an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet) includes an implant. In some implementations, the implant can include, among other components, wings and / or an interface. The wings can have a root portion and / or a tip portion.

[0151] In some implementations, the interface is coupled to a root portion of the wing. In some implementations, the interface can be configured to receive an anchor.

[0152] In some implementations, the interface is configured to be anchored to a site within a heart chamber such that the implant is positioned with the wings extending over the first leaflet and toward the opposing leaflet.

[0153] In some implementations, the wings can be configured to deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart, the wings being configured to define deflection limits and to become resistant to upstream deflection when the deflection limits are reached.

[0154] In some implementations, the implant is sterilized.

[0155] In some implementations, the wings can be configured to resist upstream deflection by contacting the tip portion of the wing against the root portion of the wing when the wing reaches its deflection limit.

[0156] In some implementations, the wing includes a hinge that articulately connects the root portion of the wing to the tip portion of the wing.

[0157] In some implementations, the hinge can be configured with a range of motion that defines the deflection limits of the wing.

[0158] In some implementations, the tip portion includes at least a first portion and a second portion, the second portion being deflectable relative to the first portion and / or contacting the first portion when the wing reaches a deflection limit.

[0159] In some implementations, the first portion is closer to the root portion than the second portion.

[0160] In some implementations, the first portion is closer to the interface compared to the second portion.

[0161] In some implementations, the tip portion further includes a third portion, the third portion being deflectable relative to the second portion and / or contacting the second portion when the wing reaches its deflection limit.

[0162] In some implementations, the second portion is closer to the root portion than the third portion.

[0163] In some implementations, the second portion is closer to the interface than the third portion.

[0164] In some implementations, at least one of the first portion, the second portion, and the third portion has a different flexibility relative to at least another of the first portion, the second portion, and the third portion.

[0165] In some implementations, the wings include a flexible frame, the frame being more flexible for downstream deflection compared to upstream deflection.

[0166] In some implementations, the frame has a number of notches cut therein.

[0167] In some implementations, the implant is configured such that deflecting the wings in a downstream direction widens the notch, and deflecting the wings in an upstream direction narrows the notch.

[0168] In some implementations, the notches are a first set of notches and the frame has a second set of notches cut therein, and in some implementations, the implant is configured such that (i) deflection of the frame in a downstream direction widens the first set of notches and narrows the second set of notches, and / or (ii) deflection of the frame in an upstream direction narrows the first set of notches and widens the second set of notches.

[0169] In some implementations, the notch is located upstream from the frame.

[0170] In some implementations, the notches are a first set of notches and the frame has a second set of notches cut therein, the second set of notches being located downstream from the frame.

[0171] In some implementations, the frame is configured such that bending the frame in a first direction widens the first set of notches and narrows the second set of notches, and such that bending the frame in a second direction narrows the first set of notches and widens the second set of notches.

[0172] According to some implementations, a system and / or device (e.g., for use with a cardiac valve of a live subject or a simulation, the valve having an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet) includes an implant, a delivery tool, a first anchor, and a second anchor. In some implementations, the implant can include wings, a first interface, and a second interface.

[0173] In some implementations, the wings may have a root portion and / or a tip portion and may define a first surface (e.g., a contact surface) and a second surface (e.g., an opposite surface, a surface opposite the first surface, etc.).

[0174] In some implementations, the first interface can define a first longitudinal axis and the second interface can define a second longitudinal axis, each of the first interface and the second interface being disposed at the root portion and coupled to the wing such that the first longitudinal axis is non-parallel to the second longitudinal axis.

[0175] In some implementations, the delivery tool includes, among other components, a catheter, a first shaft, a second shaft, a first driver, and a second driver, wherein the catheter is transluminally advanceable into the heart chamber.

[0176] In some implementations, the first shaft and the second shaft are capable of engaging with corresponding first and second interfaces and / or are configured to (i) deploy the implant from the catheter and (ii) position the implant in place via engagement with the corresponding interfaces.

[0177] In some implementations, in a predetermined position, the first interface is located at a first portion upstream of the valve, the second interface is located at a second portion upstream of the valve, and / or the wings can extend over the first leaflet toward the opposing leaflet with the contact surface facing the first leaflet.

[0178] In some implementations, each driver can be engaged with a corresponding first anchor and second anchor and configured to secure the implant in place by threading the first anchor along a first longitudinal axis to anchor the first interface to tissue at a first location and by threading the second anchor along a second longitudinal axis to anchor the second interface to tissue at a second location.

[0179] In some implementations, the implant is sterilized, in some implementations, the first anchor and the second anchor are sterilized, and in some implementations, the delivery tool is sterilized.

[0180] In some implementations, for each of the first and second interfaces, the interface has a proximal end that is perpendicular to the longitudinal axis of the interface.

[0181] In some implementations, each of the first and second interfaces has a circular proximal end.

[0182] In some implementations, the root portion of the wing defines a plane that is inclined relative to both the first longitudinal axis and the second longitudinal axis.

[0183] In some implementations, when the first and second shafts are engaged with their corresponding interfaces, each shaft is inclined relative to a plane defined by the root portions of the wings.

[0184] In some implementations, the angle between the first longitudinal axis and the plane defined by the root portion of the wing is equal to the angle between the second longitudinal axis and the plane defined by the root portion of the wing.

[0185] In some implementations, the angle between the first longitudinal axis and the plane defined by the root portion of the wing is not equal to the angle between the second longitudinal axis and the plane defined by the root portion of the wing.

[0186] In some implementations, the implant defines a first angle between the first longitudinal axis and a planar area disposed between the first interface and the second interface, and a second angle between the second longitudinal axis and the planar area, hi some implementations, the first angle is greater than the second angle.

[0187] In some implementations, the first angle and the second angle are both acute angles.

[0188] In some implementations, the first angle is an obtuse angle.

[0189] In some implementations, the second angle is an acute angle.

[0190] In some implementations, the first interface includes a first cylindrical tube extending along a first longitudinal axis, and / or the second interface includes a second cylindrical tube extending along a second longitudinal axis.

[0191] In some implementations, each of the first and second cylindrical tubes has a circular cross-section transverse to the respective longitudinal axis and / or a non-circular, elliptical distal end.

[0192] In some implementations, each of the first and second interfaces has a distal end that is angled relative to the longitudinal axis of the respective interface.

[0193] In some implementations, the distal ends of each of the first and second interfaces are parallel to a plane defined by the root portions of the wings.

[0194] In some implementations, the first interface and the second interface each have a proximal end that is angled relative to a plane defined by the root portion.

[0195] In some implementations, the anchors have anchor heads from which tissue engaging elements extend, and / or for each of the first anchor and second anchor, a corresponding driver can be configured to thread the anchor along a corresponding longitudinal axis until the anchor head abuts the proximal end of the corresponding interface.

[0196] According to some implementations, a system and / or device (e.g., that can be used with tissue, e.g., of a live subject or a simulated subject) includes an anchor, an implant, and a delivery tool. The implant can include a ratcheting interface that can be configured to be anchored to a site in the tissue.

[0197] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter is transluminally advanceable into the heart chamber.

[0198] In some implementations, the shaft can engage with the interface and / or can be configured to (i) deploy the implant from the catheter and / or (ii) position the implant in place via engagement with the interface.

[0199] In some implementations, in place, the interface can be located at a site upstream from the valve, and the driver can engage the anchor and / or can be configured to anchor the interface to the site by spirally advancing the anchor distally through the interface and into tissue at the site.

[0200] In some implementations, the interface can be configured to prevent non-helical advancement of the anchor distally through the interface and to facilitate non-helical withdrawal of the anchor proximally through the interface.

[0201] In some implementations, the implant is sterilized, in some implementations, the anchor is sterilized, and in some implementations, the delivery tool is sterilized.

[0202] In some implementations, the interface includes a tubular anchor-receiving member defining a lumen and / or a tab projecting into the lumen, such that application of a non-helical distal force to the anchor prevents non-helical distal advancement by the anchor abutting against the tab.

[0203] In some implementations, the tabs can be configured to deflect outward in response to application of a non-helical proximal force to the anchor, thereby facilitating non-helical proximal withdrawal.

[0204] In some implementations, the anchor includes a helical tissue-engaging element and / or the tab can be configured such that when a non-helical distal force is applied to the anchor, the helical tissue-engaging element abuts against the tab, thereby preventing non-helical distal advancement.

[0205] In some implementations, the helical tissue-engaging element is configured to slide helically over the tab upon helical distal advancement of the anchor through the interface.

[0206] In some implementations, the tabs are configured such that when a non-helical proximal force is applied to the anchor, the helical tissue engaging element biases the tabs outward to facilitate non-helical proximal withdrawal.

[0207] In some implementations, the tab is configured such that when a non-helical proximal force is applied to the anchor, the helical tissue engaging element ratchets proximally through the lumen past the tab to facilitate non-helical proximal withdrawal.

[0208] According to some implementations, a system and / or apparatus (e.g., usable with a cardiac valve of a live subject or a simulation) includes an implant and a delivery tool. In some implementations, the implant can be a wing and can include wings extending from a wing root portion to a wing tip portion, and / or can include wings defining a first surface (e.g., a contact surface) and a second surface (e.g., an opposing surface, a surface opposite the first surface, etc.).

[0209] In some implementations, the wings have a compressed state and an extended state.

[0210] In some implementations, the wings include a flexible frame that includes a shape memory material and biases the wings toward the expanded state, hi some such implementations, the wings and / or the flexible frame are self-expandable and can expand to the expanded state when the wings are advanced from a catheter.

[0211] In some such implementations, the wings and / or frame are mechanically expandable and can be actuated to expand into an expanded state when or after the wings are advanced from the catheter.

[0212] In some implementations, the wings can include extension elements coupled to the wings, the extension elements having a compact state and an extended state in which the extension elements resist compression of the wings toward the compressed state.

[0213] The valve may have a first leaflet and an opposing leaflet, and / or the heart may have a chamber located upstream from the valve.

[0214] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. In some implementations, the catheter is transluminally advanceable into the heart chamber, where it contains the implant when the wings are in a compressed state and the expansion element is in a compact state.

[0215] In some implementations, the catheter is transluminally advanceable into the heart chamber, where the shaft is disposed within the catheter, and the shaft engages the implant.

[0216] In some implementations, the delivery tool is configured to deploy the implant from the catheter within the heart chamber with the wings in an expanded state and the expansion element in an extended state.

[0217] In some implementations, the delivery tool is configured to position the implant in a predetermined position with the wings extending over the first leaflet toward the opposing leaflet and the first surface, i.e., the contact surface, facing the first leaflet.

[0218] In some implementations, the implant is sterilized. In some implementations, the delivery tool is sterilized.

[0219] In some implementations, the expansion element is configured to resist transitioning from the extended state towards the compact state.

[0220] In some implementations, the expansion element includes a spring.

[0221] In some implementations, the expandable element includes multiple subunits, and the expandable element is configured such that the subunits interlock with one another as the expandable element extends to the extended state.

[0222] In some implementations, the expansion element includes multiple sub-units that are configured to lock together when the expansion element is in the extended state.

[0223] In some implementations, the expansion element is straighter in the extended state compared to the compact state.

[0224] In some implementations, the expansion element includes a hinge, and the expansion element can be configured such that straightening the hinge straightens the expansion element.

[0225] In some implementations, the delivery tool further includes an expansion actuator configured to transluminally extend the expansion element from the compact state to the extended state.

[0226] In some implementations, the implant is configured to apply an expansion force to the wings by extending the expansion element from a compact state to an extended state, the expansion force facilitating the expansion of the wings from the compressed state to the expanded state.

[0227] In some implementations, the implant includes a pair of interfaces at the root portions of the wings, and in some implementations, the shaft branches into two branches at the distal portion of the shaft, each of which engages a corresponding one of the interfaces.

[0228] In some implementations, the expandable element is configured to compress the interfaces apart as the expandable element extends toward its expanded state.

[0229] In some implementations, the extension element is coupled to the wing via a pair of interfaces.

[0230] In some implementations, the expansion actuators are positioned between the branches.

[0231] According to some implementations, the system and / or device (e.g., for use with a cardiac valve of a live subject or a simulation, the valve having an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant can include, among other components, wings, a frame that provides mechanical support to the wings, and / or an interface located at the root portion.

[0232] In some implementations, the wings can have root and / or tip portions and a flexible sheet that covers the frame and extends beyond the frame to define side flaps.

[0233] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter can be configured to be transluminally advanceable into a chamber of the heart.

[0234] In some implementations, the shaft can engage with the interface and / or can be configured to (i) deploy the implant from the catheter and / or (ii) position the implant in place via engagement with the interface.

[0235] In some implementations, in position, the interface can be located at an upstream portion of the valve, and / or the wings can extend over the first leaflet toward the opposing leaflet and the lateral flaps can extend over the first leaflet toward the respective commissure of the valve.

[0236] In some implementations, the driver can be configured to engage an anchor and / or to secure the implant in place using the anchor, thereby anchoring the interface to cardiac tissue at the site.

[0237] In some implementations, the implant is sterilized, in some implementations, the anchor is sterilized, and in some implementations, the delivery tool is sterilized.

[0238] In some implementations, the wings are more flexible at the side flaps compared to the inner region where the frame is located.

[0239] In some implementations, the flexible sheet has a shape similar to that of a manta ray.

[0240] In some implementations, each of the side flaps defines a lateral end between a root portion of the side flap and a tip portion of the side flap.

[0241] In some implementations, the lateral ends are angled.

[0242] According to some implementations, a system and / or device (e.g., usable with a cardiac valve of a live subject or a simulation) includes an implant, the implant including a wing and an interface located at a root portion. In some implementations, the wing extends from the wing root portion to the wing tip portion, the root portion being stiffer than the tip portion, and the wing defines a first surface (e.g., a contact surface) and a second surface (e.g., an opposite surface, a surface opposite the first surface, etc.).

[0243] The valve may have a first leaflet and an opposing leaflet, and / or the heart may have a chamber located upstream from the valve.

[0244] In some implementations, the implant is configured to be implanted in a predetermined position where the interface is located at a location upstream of the valve and the wings extend over the first leaflet toward the opposing leaflet and the first surface / contact surface faces the first leaflet.

[0245] In some implementations, the implant is sterilized.

[0246] In some implementations, the wings include a flexible frame that provides mechanical support for the root portion of the wing.

[0247] In some implementations, the tip portions of the wings include a flexible sheet.

[0248] In some implementations, the flexible sheet comprises a polymer.

[0249] In some implementations, the wing includes a flexible frame that provides mechanical support for the wing.

[0250] In some implementations, the flexible frame defines a smaller open space at the root portion of the wings compared to the tip portion of the wings.

[0251] In some implementations, the frame members are thicker at the root of the wing compared to the tip of the wing.

[0252] In some implementations, the frame members are spaced closer to each other at the root portion of the wing compared to the tip portion of the wing.

[0253] In some implementations, the flexible frame comprises a wire frame, the wire frame comprising thicker wire at the root portion of the wing compared to the tip portion of the wing.

[0254] In some implementations, the frame at the root portion of the wing comprises a first material and the frame at the tip portion of the wing comprises a second material, hi some implementations, the first material is harder than the second material.

[0255] In some implementations, the flexible frame includes a wire frame in which the wires are more densely arranged at the root portion of the wing compared to the tip portion of the wing.

[0256] In some implementations, the wire frame includes thicker wire at the root portion of the wing compared to the tip portion of the wing.

[0257] In some implementations, the wings include a mesh (eg, a mesh formed from wire).

[0258] In some implementations, the wing further includes a flexible frame with a mesh disposed thereover.

[0259] In some implementations, the mesh has a tighter weave at the root portion than at the tip portion.

[0260] In some implementations, the mesh includes thicker wires in the root portion compared to the tip portion.

[0261] In some implementations, the wing defines a bending element that connects a tip portion of the wing to a root portion of the wing.

[0262] In some implementations, the implant is configured such that when the implant is secured in place, the bending element bends to facilitate deflection of the tip portion relative to the base portion in response to the cardiac cycle of the heart.

[0263] According to some implementations, the method (which may be used to treat a valve in a heart, e.g., of a live subject or a simulation, where the valve may have an annulus, a first leaflet, and an opposing leaflet) includes advancing a catheter, a shaft, and an implant into a heart chamber. In some implementations, the implant includes an interface engaged to a distal end of the shaft and flexible wings coupled to the interface.

[0264] In some implementations, the method includes deploying the implant from the catheter into the heart chamber using the shaft and positioning the implant in a predetermined position with the interface located at a site on the valve annulus and the wings extending over the first leaflet toward the opposing leaflet.

[0265] In some implementations, the method includes anchoring the interface at the site.

[0266] In some implementations, the method includes subsequently pulling the ripcord to release the distal end of the shaft from the interface and / or subsequently withdrawing the catheter and shaft from the subject.

[0267] In some implementations, the method further includes sterilizing the implant.

[0268] In some implementations, the method further includes sterilizing the catheter and shaft.

[0269] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0270] According to some implementations, the method (which may be used to treat a valve in a heart, e.g., of a live subject or a simulation, where the valve may have an annulus, a first leaflet, and an opposing leaflet) includes advancing a shaft and an implant within a catheter into a heart chamber. In some implementations, the implant includes an interface engaged to a distal end of the shaft and flexible wings coupled to the interface.

[0271] In some implementations, the method includes deploying the implant from the catheter into the heart chamber using the shaft.

[0272] In some implementations, the method includes positioning the implant in a predetermined location with the interface located at a site on the valve annulus and the wings extending over the first leaflet toward the opposing leaflet.

[0273] In some implementations, the method includes anchoring the interface at the site.

[0274] In some implementations, the method includes subsequently pulling the ripcord to release the distal end of the shaft from the interface and / or subsequently withdrawing the catheter and shaft from the subject.

[0275] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0276] According to some implementations, a system and / or device (e.g., which can be used with tissue of a living subject or a simulation) includes an implant including a first anchor and a second anchor, a first interface and a second interface, and a delivery tool.

[0277] In some implementations, the delivery tool includes, among other components, a catheter, a first driver, a second driver, and a shaft extending distally through the catheter.

[0278] In some implementations, the catheter is transluminally advanceable into tissue, and the distal portion of the shaft branches into a first branch and a second branch, each branch positioned alongside one another within the catheter.

[0279] In some implementations, the first and second prongs can mate with corresponding ones of the first and second interfaces.

[0280] In some implementations, a first driver can extend distally through the shaft into the first branch, and within the first branch, a drive head of the first driver can be configured to engage the first anchor and anchor the first interface to the tissue by driving the anchor distally through the first interface and into the tissue.

[0281] In some implementations, a second driver can extend distally through the shaft alongside the first driver into the second branch, where the drive head of the second driver can be configured to engage a second anchor and drive the anchor distally through the second interface and into the tissue, thereby anchoring the second interface to the tissue.

[0282] In some implementations, the implant is sterilized, in some implementations, the first anchor and the second anchor are sterilized, and in some implementations, the delivery tool is sterilized.

[0283] In some implementations, the first branch has a first width and the second branch has a second width, and / or the portion of the shaft located proximal to the first and second branches is narrower than the sum of the first and second widths.

[0284] In some implementations, the catheter defines a first lumen and a second lumen juxtaposed to the first lumen, and / or each of the first and second drivers extends from a proximal portion to a distal portion within a corresponding lumen.

[0285] In some implementations, the delivery tool further includes a controller configured to drive the first driver and the second driver.

[0286] In some implementations, the controller is capable of transitioning between a first setting in which the controller drives the first driver and the second driver simultaneously, and a second setting in which the controller drives only one of the first driver or the second driver at a given time.

[0287] In some implementations, any of the implants described above can include legs or extensions extending from the tips of the wings to the end portions of the legs. In some implementations, when the implant is implanted, the legs or extensions extend from the wings of the implant such that, upon implantation, the legs or extensions protrude into the heart chamber downstream from the valve being treated.

[0288] In some implementations, the legs or extensions are configured to bias the wings of the implant toward a particular position and / or orientation and / or to prevent the wings from protruding into the atrium upstream of the valve being treated.

[0289] In some implementations, the legs are configured to maintain contact between the wings and the leaflets as the leaflets oscillate through multiple cardiac cycles.

[0290] According to some implementations, a method usable with a valve of a real or simulated heart (e.g., the valve can have a first valve leaflet and an opposing valve leaflet, and / or the heart can have a first heart chamber located upstream of the valve and a second heart chamber located downstream of the valve) includes advancing a shaft and / or implant within a catheter into the first heart chamber, the implant including an interface engaged with a distal end of the shaft and / or flexible wings coupled to the interface.

[0291] In some implementations, the method can include deploying the implant from the catheter into the first heart chamber using the shaft and / or anchoring the implant.

[0292] In some implementations, the implant can be implanted in a predetermined position where the interface is located at a site within the first heart chamber and the wings extend over the first leaflet toward the opposing leaflet, and where the wings deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0293] In some implementations, the method includes adjusting the deflection range of the wings within the heart (eg, after implantation).

[0294] In some implementations, the method further includes sterilizing the implant, the shaft, and the catheter.

[0295] In some implementations, the site is located at an annulus of the valve, and / or anchoring the implant in place includes anchoring the interface to the annulus of the valve.

[0296] In some implementations, the interface is coupled to a root portion of the wing, and / or anchoring the interface to the annulus includes anchoring the interface to the annulus with the root portion positioned at the annulus and the wings extending from the root portion over the first leaflet and toward the opposing leaflet.

[0297] In some implementations, the implant further includes a limiter that defines a deflection limit of the wing during a cardiac cycle of the heart by preventing the wing from deflecting upstream beyond the deflection limit, and / or adjusting the deflection range of the wing includes adjusting the deflection limit of the wing within the heart by adjusting the limiter.

[0298] In some implementations, anchoring the implant in place includes driving an anchor into tissue at the site, and / or adjusting the limiter includes adjusting the limiter by applying a torque to the anchor.

[0299] In some implementations, the limiter includes a tether coupled to the wing, and / or adjusting the deflection range of the wing includes adjusting the deflection limit of the wing by adjusting tension on the tether within the heart.

[0300] In some implementations, the method further includes anchoring the tether to tissue of the second heart chamber before adjusting the tension.

[0301] In some implementations, a portion of the tether is wound around a rotatable spool, and / or adjusting the tension on the tether includes adjusting the tension on the tether via the catheter by rotating the spool using an external controller.

[0302] In some implementations, adjusting tension on the tether within the heart includes sliding the tether within the heart relative to the wings.

[0303] In some implementations, a first portion of the tether is coupled to the wing and / or adjusting the tension on the tether includes passing a second portion of the tether upstream through a root portion of the wing.

[0304] In some implementations, adjusting the tension on the tether includes passing a second portion of the tether upstream through the interface.

[0305] In some implementations, anchoring the implant in place includes anchoring the interface to the tissue by driving the anchor into the tissue at the site, and further wherein the anchor has an anchor head and a tissue engaging element extending from the anchor head to define an anchor axis of the anchor, and / or adjusting the limiter includes biasing the limiter relative to the anchor axis.

[0306] In some implementations, deflecting the restrictor includes changing the curvature of the restrictor.

[0307] In some implementations, deflecting the restrictor includes bringing the restrictor into greater contact with the wing.

[0308] In some implementations, deflecting the restrictor includes deflecting the restrictor such that a portion of the restrictor contacts the wing when the wing reaches a deflection limit.

[0309] In some implementations, deflecting the restrictor includes deflecting the restrictor such that a portion of the restrictor does not contact the wing during a ventricular diastole of a cardiac cycle.

[0310] In some implementations, anchoring the implant in place includes driving anchors into tissue at the site, and / or adjusting the limiter includes adjusting the limiter by driving anchors deeper into tissue at the site.

[0311] In some implementations, the anchor has an anchor head and a tissue engaging element, the tissue engaging element extending from the anchor head and defining an anchor axis of the anchor, and / or adjusting the limiter includes biasing the limiter relative to the anchor axis.

[0312] In some implementations, the restrictor defines a rear catch, and / or adjusting the restrictor includes pressing the rear catch against tissue of the first heart chamber.

[0313] In some implementations, the rear catch defines a spring, and / or pressing the rear catch against tissue of the first heart chamber includes applying tension to the spring.

[0314] In some implementations, the rear catch portion is an expandable rear catch portion, and / or pressing the rear catch portion against tissue of the first heart chamber includes expanding the rear catch portion to press the rear catch portion against the tissue.

[0315] In some implementations, the implant includes a tether coupled to the wing, and / or adjusting the range of deflection of the wing within the heart includes adjusting the range of deflection of the wing within the heart by adjusting tension on the tether.

[0316] In some implementations, the tether is coupled to a tip portion of the wing, and / or adjusting the tension on the tether includes adjusting the deflectability of the tip portion of the wing.

[0317] In some implementations, the tether is coupled to the wing and / or the method further includes anchoring the tether to tissue of the second heart chamber.

[0318] In some implementations, the tether defines a rail portion to which a proximal portion of the tether is slidably coupled.

[0319] In some implementations, the anchoring step includes anchoring a first portion of the rail portion to the trabeculae at a first location in the second heart chamber and / or anchoring a second portion of the rail portion to the trabeculae at a second location in the second heart chamber.

[0320] In some implementations, a first portion of the tether is coupled to the wing and / or adjusting the tension on the tether includes passing a second portion of the tether upstream through a root portion of the wing.

[0321] In some implementations, adjusting the tension on the tether includes passing a second portion of the tether upstream through the interface.

[0322] In some implementations, adjusting the range of deflection of the wing by adjusting the tension on the tether includes adjusting the tension on the tether to pivot the wing relative to the interface.

[0323] In some implementations, anchoring the implant in place includes anchoring the interface to the site by driving an anchor into tissue at the site, the anchor defining (i) an anchor head and / or (ii) a tissue engaging element extending from the anchor head along an anchor axis.

[0324] In some implementations, adjusting the tension on the tether to pivot the wing relative to the interface includes adjusting the tension on the tether to pivot the wing relative to the anchor axis.

[0325] In some implementations, the interface is an adjustable interface, and / or adjusting the deflection range of the wings includes adjusting the deflection range within the heart by adjusting the interface.

[0326] In some implementations, the adjustable interface defines a seat, and anchoring the implant includes seating the seat against tissue at a location within the first heart chamber, and / or adjusting the interface includes adjusting an angle between a root portion of the wing and the seat of the interface.

[0327] In some implementations, the anchoring step includes anchoring the implant in place using an anchor.

[0328] In some implementations, the anchor defines an anchor head and a tissue engaging element extending from the anchor head along the anchor axis.

[0329] In some implementations, adjusting the interface includes adjusting an angle between a root portion of the wing and the anchor axis.

[0330] In some implementations, the adjustable interface includes an adjustment mechanism.

[0331] In some implementations, adjusting the angle between the root portion of the wing and the seat of the interface includes adjusting the angle between the root portion of the wing and the seat of the interface by actuating an adjustment mechanism.

[0332] In some implementations, the adjustable interface includes a base to which root portions of the wings are fixedly coupled.

[0333] In some implementations, adjusting the angle between the root portion of the wing and the seat of the interface includes adjusting the angle between the base and the seat of the interface by actuating an adjustment mechanism.

[0334] In some implementations, the adjustment mechanism includes a lead screw, and / or driving the adjustment mechanism includes rotating the lead screw.

[0335] In some implementations, the anchoring step includes anchoring the implant in place using an anchor.

[0336] In some implementations, the anchor defines an anchor head and a tissue engaging element extending from the anchor head along the anchor axis.

[0337] In some implementations, threading the lead screw includes threading the lead screw along a lead screw axis that is offset relative to the anchor axis.

[0338] In some implementations, the anchoring step includes anchoring the implant in place using an anchor.

[0339] In some implementations, the anchor defines an anchor head and a tissue engaging element extending from the anchor head along the anchor axis.

[0340] In some implementations, threading the lead screw includes threading the lead screw along a lead screw axis that is collinear with the anchor axis.

[0341] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0342] According to some implementations, a method usable with a valve of a real or simulated heart (e.g., the valve can have an annulus, a first leaflet, and an opposing leaflet, and the heart can have a chamber located upstream from the valve) includes advancing an implant into the heart (e.g., into a chamber of the heart). In some implementations, the implant includes wings that are wings and extend from a root portion of the wings to a tip portion of the wings, an interface located at the root portion of the wings, and / or a shape memory member coupled to the wings.

[0343] In some implementations, the method includes positioning the implant at a predetermined location where the interface is located at a site within the heart chamber and / or where the wings extend from the site, over the first leaflet, and toward the opposing leaflet.

[0344] In some implementations, the method includes anchoring the interface to the site.

[0345] In some implementations, the method includes inducing the shape memory member to permanently change the size of the wings by temporarily heating the shape memory member while the implant remains in place.

[0346] In some implementations, the method further includes sterilizing the implant.

[0347] In some implementations, the inducing step includes inducing the shape memory member to permanently change the width of the wings by temporarily heating the shape memory member while the implant remains in place.

[0348] In some implementations, the inducing step includes inducing the shape memory member to permanently change the length of the wings by temporarily heating the shape memory member while the implant remains in place.

[0349] In some implementations, a first end of the shape memory member is coupled to a root portion of the wing and / or a second end of the shape memory member is coupled to a tip portion of the wing.

[0350] In some implementations, the inducing step includes inducing the shape memory member by temporarily heating the shape memory member while the implant remains in place, thereby permanently changing the distance between the first end of the shape memory member and the second end of the shape memory member.

[0351] In some implementations, the heating step includes temporarily heating the shape memory member by applying electrical power to the shape memory member.

[0352] In some implementations, powering the shape memory member includes wirelessly powering the shape memory member.

[0353] In some implementations, applying power to the shape memory member includes applying power to the shape memory member via a catheter.

[0354] In some implementations, the wings include a locking mechanism that configures the wings to permanently stay at the changed size, and / or the method further includes temporarily unlocking the locking mechanism.

[0355] In some implementations, the shape memory member is a first shape memory member and the locking mechanism includes a second shape memory member, and / or temporarily unlocking the locking mechanism includes temporarily heating the second shape memory member.

[0356] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0357] According to some implementations, a method usable with or for use with a valve of a real or simulated heart (e.g., the valve can have an annulus, a first leaflet, and / or an opposing leaflet, and the heart can have a heart chamber located upstream from the valve) includes advancing an implant into the heart chamber. In some implementations, the implant includes one or more of: wings extending from a root portion of the wings to a tip portion of the wings; an interface located at the root portion of the wings; and / or a shape memory member coupled to the wings.

[0358] In some implementations, the method includes positioning the implant at a predetermined location where the interface is located at a site within the heart chamber and / or where the wings extend from the site, over the first leaflet, and toward the opposing leaflet.

[0359] In some implementations, the method includes anchoring the interface to the site.

[0360] In some implementations, the method includes inducing the shape memory member to permanently change the size of the wings by temporarily heating the shape memory member while the implant remains in place.

[0361] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0362] According to some implementations, systems and / or devices are provided that can be used with valves of a real or simulated heart (e.g., the valve can have an annulus, a first valve leaflet, and / or an opposing valve leaflet, and the heart can have a first chamber located upstream from the valve and a second chamber located downstream from the valve). In some implementations, the system / device can include an implant, the implant including one or more of: flexible wings, wings extending from a wing root portion to a wing tip portion, and / or limbs / extensions coupled to the wings.

[0363] In some implementations, the root portion of the wing is configured to be positioned against the annulus adjacent to the root of the first leaflet in a manner that supports the wing extending from the root portion of the wing, over the first leaflet, and toward the opposing leaflet.

[0364] In some implementations, the limbs or extensions are shaped so that when the base of the wing is placed against the site, the limbs / extensions extend away from the wing in a manner that reduces upstream deflection of the wing relative to the site and contacts tissue in the heart adjacent to the base of the opposing valve leaflet.

[0365] In some implementations, the implant is sterilized.

[0366] In some implementations, the implant is configured such that when the base portions of the wings are placed against the site and the limbs / extensions extend away from the wings to contact cardiac tissue, the tip portions of the wings deflect back and forth upstream and downstream relative to the base portions of the wings in response to the cardiac cycle.

[0367] In some implementations, the limbs / extensions are shaped such that when the base of the wing is placed against the site, the limbs / extensions extend away from the base of the wing and contact cardiac tissue in a manner that reduces upstream deflection of the wing relative to the site.

[0368] In some implementations, the limbs / extensions are shaped such that when the root portions of the wings are placed against the site, the limbs / extensions extend away from the tip portions of the wings and contact cardiac tissue in a manner that reduces upstream deflection of the wings relative to the site.

[0369] In some implementations, the limbs / extensions are shaped such that when the root portions of the wings are placed against the site, the limbs / extensions extend away from the wings and contact the annular tissue in a manner that reduces upstream deflection of the wings relative to the site.

[0370] In some implementations, the limbs / extensions define arms that are shaped such that when the root portions of the wings are positioned against the site, the arms are positioned against the atrial surface of the annulus in a manner that mitigates upstream deflection of the wings relative to the site.

[0371] In some implementations, the implant further includes an interface at a root portion of the wing, the interface configured to be secured to a site on the annulus by driving an anchor into tissue at the site.

[0372] In some implementations, the arms include anchor receiving members that are configured to be secured against the atrial surface of the annulus when the root portions of the wings are positioned against the site by driving anchors through the anchor receiving members and into tissue at the atrial surface of the annulus.

[0373] In some implementations, the arms are shaped such that when the root portions of the wings are placed against the site, the anchor receiving members are positioned adjacent to the commissures of the valve.

[0374] In some implementations, the arms are shaped such that when the root portions of the wings are positioned against the site, the anchor receiving member is positioned adjacent to the root portion of the first leaflet.

[0375] In some implementations, the arms are shaped such that when the root portions of the wings are placed against the site, the anchor receiving member is positioned adjacent to the root portions of the opposing leaflets.

[0376] In some implementations, the limbs / extensions define legs that are shaped such that when the bases of the wings are positioned against the site, the legs contact the tissue of the ventricle in a manner that reduces upstream deflection of the wings relative to the site.

[0377] In some implementations, the implant further includes an interface at a root portion of the wing, the interface configured to be secured to a site on the annulus by driving an anchor into tissue at the site.

[0378] In some implementations, the legs are shaped so that when the root portions of the wings are placed against the site, the legs contact the tissue below the valve in a manner that reduces upstream deflection of the wings relative to the site.

[0379] In some implementations, the legs are shaped such that when the root portions of the wings are placed against the site, the legs are positioned adjacent the commissures of the valve.

[0380] In some implementations, the legs are shaped such that when the root portions of the wings are placed against the site, the legs are positioned within the subannular groove of the valve.

[0381] In some implementations, the implant further includes an atrial support coupled to the wings and configured such that when the root portions of the wings are positioned against the site, the atrial support presses against the atrial surface of the annulus in a manner that presses the legs against the ventricular tissue.

[0382] In some implementations, the atrial support is shaped to surround the atrial surface of the annulus.

[0383] In some implementations, the atrial support is defined by a pair of arms that extend in opposite directions from a root portion around the atrial face of the annulus.

[0384] In some implementations, the ventricle is the left ventricle, the valve is the mitral valve, the first leaflet is the posterior leaflet of the mitral valve, and the opposing leaflet is the anterior leaflet of the mitral valve.

[0385] In some implementations, the legs are shaped so that when the root portions of the wings are placed against the site, the legs contact the tissue of the left ventricle posterior to the anterior leaflet.

[0386] In some implementations, the legs are shaped so that when the base of the wings is placed against the site, the legs contact the fibrous trigone of the left ventricle.

[0387] In some implementations, the wings have a compressed state, in some implementations, the wings are biased to expand to an expanded state, and in some implementations, the wings can be actuated to expand to an expanded state.

[0388] In some implementations, the limb / extension includes an annular support. In some implementations, the annular support is coupled to a root portion of the wing. In some implementations, the annular support is configured such that, in the compressed state of the wing, the wing has a hinged connection to the annular support and articulation of the wing relative to the annular support is facilitated at the hinged connection. In some implementations, expansion of the wing toward the expanded state prevents articulation due to constraint at the hinged connection.

[0389] In some implementations, the implant further includes an interface at the root portion of the wing.

[0390] In some implementations, the wing defines a contact surface and an opposing surface opposite the contact surface.

[0391] In some implementations, the system further includes an anchor and / or a delivery tool, hi some implementations, the delivery tool includes a catheter that is transluminally advanceable into the atrium with the implant housed within the catheter when the wings are in a compressed state.

[0392] In some implementations, the delivery tool further includes a driver configured to deploy the implant from the catheter with the wings in an expanded state within the first heart chamber, and the driver configured to position the implant in a predetermined position with the wings extending over the first leaflet toward the opposing leaflet and / or with the contact surface facing the first leaflet.

[0393] In some implementations, when the implant is in place and the wings are in an expanded state, anchors are configured to be driven through the interface and into the tissue of the annulus, thereby securing the interface to the annulus.

[0394] In some implementations, the annular support is shaped to rest against the atrial surface of the annulus when the implant is secured to the annulus and the wings are in an expanded state, thereby constraining the hinge joint and preventing deflection of the wing roots relative to the annulus.

[0395] In some implementations, the interface is a first interface and the annular support includes a first annular arm extending away from the hinge joint to the first interface, and / or the annular support further includes a second annular arm, and the second annular arm is coupled to the hinge joint and / or extends away from the hinge joint to the second interface.

[0396] In some implementations, the first annular arm is joined to the second annular arm at a hinge joint.

[0397] In some implementations, the implant is configured such that the hinge joint includes a sleeve defining an opening.

[0398] In some implementations, the implant is configured such that when the wings are in a compressed state, a thinned portion of the annular support is disposed within the opening.

[0399] In some implementations, the implant is configured such that the wings expand toward the expanded state to slide the sleeve from the thinned portion into the thickened portion of the annular support, hi some implementations, the thickened portion has a cross-section sized to fit into the opening and thereby restrain the hinge joint.

[0400] In some implementations, the thickened portion of the annular support has an oval cross section sized to fit into the opening and thereby restrain the hinge joint.

[0401] In some implementations, the sleeve is a first sleeve defining a first opening. In some implementations, the hinge joint further includes a second sleeve defining a second opening.

[0402] In some implementations, the annular support includes a pair of annular arms, each having a thinned portion where the arms are joined and / or a thickened portion extending away from the thinned portion.

[0403] In some implementations, the wings expand toward the expanded state, causing each sleeve to slide from a thinned portion to a thickened portion of the corresponding annular arm, thereby constraining the hinge joint.

[0404] According to some implementations, a system and / or device usable with a valve of a real or simulated heart (e.g., the valve can have a first leaflet and an opposing leaflet, and the heart can have a chamber located upstream from the valve) includes an implant, the implant being a wing and including wings extending from a wing root portion to a wing tip portion. In some implementations, the implant can include an interface located at the wing root portion.

[0405] In some implementations, the interface is configured to be anchored to a site within the first heart chamber such that the implant is fixed in a predetermined position where the wings extend over the first leaflet toward the opposing leaflet and / or deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0406] In some implementations, the system / device includes an adjustment member that is adjustable in a manner that adjusts the range of deflection of the wing.

[0407] In some implementations, the implant is sterilized.

[0408] In some implementations, the adjustment member is an adjustment mechanism that is actuatable by the application of torque.

[0409] In some implementations, the adjustment member includes an adjustable limiter that prevents the wing from deflecting upstream beyond the deflection limit, thereby defining the deflection limit of the wing during the cardiac cycle of the heart, and / or the limiter is adjustable in a manner that adjusts the deflection limit of the wing within the heart.

[0410] In some implementations, the system / device further includes a catheter and / or an external controller, the controller configured to adjust the restrictor via the catheter.

[0411] In some implementations, the limiter defines a rear stop and / or the limiter is adjustable by pressing the rear stop against tissue of the first heart chamber.

[0412] In some implementations, the rear catch defines a spring, and / or the limiter can be configured to apply tension to the spring to press the rear catch against tissue of the first heart chamber.

[0413] In some implementations, the rear catch is an expandable rear catch, and / or the restrictor can be configured to expand the rear catch to press the rear catch against tissue of the first heart chamber.

[0414] In some implementations, the restrictor is configured so that a portion of the restrictor contacts the wing when the wing reaches its deflection limit.

[0415] In some implementations, the restrictor is configured such that no portion of the restrictor contacts the wing during the ventricular diastole of the cardiac cycle.

[0416] In some implementations, the system / device further includes an anchor and / or a driver that engages with the anchor.

[0417] In some implementations, the system / device is configured to drive anchors into tissue at the site, using the anchors to secure the implant in place and anchor the interface to the site, and / or to adjust the limiter by driving anchors deeper into tissue at the site.

[0418] In some implementations, the driver is configured to drive anchors into tissue at the site to secure the implant in place and further anchor the interface to the site.

[0419] In some implementations, the anchor includes an anchor head and a tissue engaging element extending from the anchor head and defining an anchor axis of the anchor, and / or the limiter can be configured such that driving the anchor deeper into tissue at the site adjusts the limiter by biasing the limiter relative to the anchor axis.

[0420] In some implementations, the driver is configured to apply a torque to the anchor to drive the anchor deeper into tissue at the site.

[0421] In some implementations, the limiter is configured such that the limiter is adjusted by driving the anchor deeper into the tissue at the site, causing the limiter to make greater contact with the wings.

[0422] In some implementations, the limiter is configured such that the limiter is adjusted by driving the anchor deeper into the tissue at the site, thereby changing the curvature of the limiter.

[0423] In some implementations, the limiter includes a tether, and the tether is coupled to the wing, and / or the limiter is configured such that the deflection limits of the wing are adjusted by adjusting tension on the tether within the heart.

[0424] In some implementations, the limiter is configured such that the deflection limits of the wings are adjusted by adjusting the tension on the tether within the heart by sliding the tether relative to the wings within the heart.

[0425] In some implementations, a portion of the tether is wound around a rotatable spool, and / or the limiter is configured such that the tension on the tether is adjusted within the heart by rotating the spool, thereby adjusting the deflection limits of the wings.

[0426] In some implementations, a first portion of the tether is coupled to the wing and / or the tether is configured such that tension on the tether is adjusted by passing a second portion of the tether upstream through the root portion of the wing.

[0427] In some implementations, the tether is configured such that tension on the tether is adjusted by passing a second portion of the tether upstream through the interface.

[0428] In some implementations, the adjustment member includes a tether and / or the implant is configured such that adjusting the tension on the tether adjusts the range of deflection of the wings.

[0429] In some implementations, the system / device further includes a catheter and / or an external controller, the controller configured to adjust tension on the tether via the catheter.

[0430] In some implementations, a tether is coupled to the tip portion of the wing, and / or the implant is configured such that adjusting the tension on the tether adjusts the deflectability of the tip portion of the wing.

[0431] In some implementations, a first portion of the tether is coupled to the wing, and / or the implant is configured such that the range of deflection of the wing is adjusted by passing a second portion of the tether through a base portion of the wing.

[0432] In some implementations, the implant is configured such that the range of deflection of the wings is adjusted by passing a second portion of the tether through the interface.

[0433] In some implementations, the implant is configured such that the range of deflection of the wings is adjusted by adjusting the tension on the tethers to pivot the wings relative to the interface.

[0434] In some implementations, the system / device further includes an anchor having an anchor head and a tissue engaging element extending from the anchor head and defining an anchor axis.

[0435] In some implementations, the implant is configured such that the range of deflection of the wings is adjusted by adjusting the tension on the tethers to pivot the wings relative to the anchor axis.

[0436] In some implementations, the adjustment member is defined by an interface, the interface being an adjustable interface that includes an adjustment mechanism that is adjustable in a manner that adjusts the range of deflection of the wing.

[0437] In some implementations, the system / device further includes a catheter and / or an external controller, the controller configured to adjust the adjustment mechanism via the catheter.

[0438] In some implementations, the adjustment mechanism (i) defines a seat configured to seat against tissue at the site, and / or (ii) can be configured to adjust the range of deflection of the wing by adjusting the angle between the base of the wing and the seat.

[0439] In some implementations, the system / device further includes an anchor having an anchor head and a tissue engaging element extending from the anchor head and defining an anchor axis.

[0440] In some implementations, the adjustment mechanism is configured to adjust the deflection range of the wing by adjusting the angle between the root portion of the wing and the anchor axis.

[0441] In some implementations, the system / device further includes a catheter and / or an external controller, the controller configured to adjust the adjustment mechanism via the catheter.

[0442] In some implementations, the adjustment mechanism can be configured to (i) include a base to which the root portion of the wing is fixedly coupled, and / or (ii) adjust the angle between the base and the seat to adjust the deflection range of the wing.

[0443] In some implementations, the adjustment mechanism can (i) include a lead screw and / or (ii) be configured such that the angle between the base and the seat is adjusted by rotating the lead screw.

[0444] In some implementations, the system / device further includes an anchor having an anchor head and a tissue engaging element extending from the anchor head and defining an anchor axis of the anchor, and the lead screw defining a lead screw axis offset relative to the anchor axis.

[0445] In some implementations, the system / device further includes an anchor having an anchor head and a tissue engaging element extending from the anchor head and defining an anchor axis of the anchor, and the lead screw defining a lead screw axis collinear with the anchor axis.

[0446] According to some implementations, a system and / or device usable with a valve of a real or simulated heart (e.g., the valve can have an annulus, a first leaflet, and / or an opposing leaflet, and the heart can have a chamber located upstream from the valve) includes an implant. In some implementations, the implant can include a flexible wing extending from a root portion of the wing to a tip portion of the wing, and a pair of arms coupled to and spaced divergently from the wing.

[0447] In some implementations, each of the arms has an anchor point configured to be anchored to the annulus, such that the arms arc from the anchor point along the annulus to the wings.

[0448] In some implementations, the wings are fixed in place with the root portion positioned against the annulus, and the wings extend from the root portion over the first leaflet and toward the opposing leaflet.

[0449] In some implementations, the wings deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0450] In some implementations, the implant is sterilized.

[0451] In some implementations, each of the pair of arms forms an arc spaced apart along the plane of the wing.

[0452] In some implementations, each of the pair of arms forms an arc spaced apart from each other and away from the plane of the wing.

[0453] In some implementations, each arm is connected to a root portion of the wing and / or forms an arc diverging away from the root portion of the wing.

[0454] In some implementations, the system / device further includes a pair of anchors, each of the anchors having an anchor head and a tissue engaging element extending from the anchor head and defining an anchor axis of the anchor, the anchor axis being generally perpendicular to a portion of each corresponding arm.

[0455] In some implementations, each arm is articulatably coupled to the wing by a hinge such that the arm articulates relative to the wing in response to reciprocating deflection of the wing when the wing is fixed in place by the anchor point of each arm anchored to the annulus.

[0456] In some implementations, each arm is articulably coupled to a wing such that when the wings are fixed in place by anchor points anchored to the annulus, the angle defined by the pair of arms becomes more acute as the wings deflect upstream.

[0457] In some implementations, the implant further includes an interface at a root portion of the wing, the interface configured to anchor the interface to the annulus, thereby securing the root portion relative to the annulus.

[0458] In some implementations, the system / device further includes a plurality of anchors, each anchor defining an anchor head and a tissue engaging portion extending from the anchor head along the anchor axis.

[0459] In some implementations, the plurality of anchors include (i) a root anchor configured to be driven into tissue of the annulus along a root anchor axis to anchor the interface to the annulus, and / or (ii) a pair of arm anchors configured to be driven into tissue of the annulus along an arm anchor axis to anchor a corresponding one of the anchor points of the arms to the annulus.

[0460] In some implementations, the wings are secured in place by multiple anchors, and the upstream deflection of the wings is closer to parallel to the root anchor axis compared to the arm anchor axis.

[0461] In some implementations, when the wings are secured in place by multiple anchors, the upstream deflection of the wings is oriented generally parallel to the root anchor axis.

[0462] In some implementations, the implant further includes a restrictor.

[0463] In some implementations, the restrictor is coupled to the wing and / or configured to prevent deflection of the wing.

[0464] In some implementations, the limiter is configured to prevent the wing from deflecting upstream beyond the deflection limit, thereby defining a deflection limit for the wing during a cardiac cycle.

[0465] In some implementations, the limiter defines a rear stop portion configured to bear against and press against tissue of the heart chamber when the anchor receiving member is anchored to the annulus.

[0466] According to some implementations, a system and / or device usable with a valve of a heart of a living subject or a simulated subject (e.g., the valve can have an annulus, a first leaflet, and / or an opposing leaflet to the first leaflet, and the heart can have a first chamber located upstream from the valve and a second chamber located downstream from the valve) includes an implant. In some implementations, the implant can include flexible wings extending from root portions of the wings to tip portions of the wings and / or legs extending from the wings to end portions of the legs.

[0467] In some implementations, the implant is configured to be secured in place with the root portion positioned against a site at the atrial surface of the valve annulus and / or the wings extending from the root portion over the first leaflet toward the opposing leaflet and / or the legs extending away from the wings to press against the underside of the valve.

[0468] In some implementations, the implant is sterilized.

[0469] In some implementations, the implant further includes an interface at the root portion of the wing.

[0470] In some implementations, the system / device further includes an anchor and / or a delivery tool.

[0471] In some implementations, the delivery tool includes a catheter that is transluminally advanceable into the first heart chamber and configured to receive the implant.

[0472] In some implementations, the delivery tool includes a shaft that houses the anchor and engages the interface.

[0473] In some implementations, the shaft is configured, via engagement with the interface, when the anchor remains within the shaft, to (i) deploy the implant from the catheter within the first heart chamber with the wings extending away from the interface, and / or (ii) position the implant in a predetermined location where (a) the interface is located at the site of the valve annulus and / or (b) the wings extend over the first leaflet toward the opposing leaflet, and / or (c) the legs extend from the tip portion and away from the wings toward the tissue of the second heart chamber.

[0474] In some implementations, the delivery tool includes a driver configured to engage the anchor and secure the implant in place using the anchor to anchor the interface to the annulus.

[0475] In some implementations, the implant is configured such that when the root portions of the wings are placed against the site and the legs extend away from the wings to press against the underside of the valve, the tip portions of the wings deflect upstream and downstream relative to the root portions of the wings in a reciprocating manner in response to the cardiac cycle.

[0476] In some implementations, the legs are shaped so that when the root portions of the wings are placed against the site, the legs extend away from the root portions of the wings in a manner that reduces upstream deflection of the wings relative to the site, thereby abutting and pressing against the underside of the valve.

[0477] In some implementations, the legs are shaped such that when the root portions of the wings are placed against the site, the legs extend away from the tip portions of the wings to contact the cardiac tissue in a manner that reduces upstream deflection of the wings relative to the site.

[0478] In some implementations, the legs are shaped so that when the root portions of the wings are placed against the site, the legs press against the underside of the valve in a manner that reduces upstream deflection of the wings relative to the site.

[0479] In some implementations, the implant further includes an interface at a root portion of the wing, the interface configured to be secured to the site by driving anchors into tissue at the site.

[0480] In some implementations, the legs are shaped so that when the root portions of the wings are placed against the site, the legs press against the tissue adjacent the commissures of the valve.

[0481] In some implementations, the legs are shaped so that when the base of the wings is placed against the site, the legs press against the tissue at the subannular groove of the valve.

[0482] In some implementations, the implant further includes an atrial support coupled to the wings and configured such that when the root portions of the wings are positioned against the site, the atrial support presses against the atrial surface of the annulus in a manner that presses the legs against tissue of the second heart chamber.

[0483] In some implementations, the atrial support is shaped to surround the atrial surface of the annulus.

[0484] In some implementations, the atrial support is defined by a pair of arms that extend in opposite directions from a root portion around the atrial face of the annulus.

[0485] In some implementations, the second heart chamber is the left ventricle and the valve is the mitral valve, and further, the first leaflet is the posterior leaflet of the mitral valve and / or the opposing leaflet is the anterior leaflet of the mitral valve.

[0486] In some implementations, the legs are shaped so that when the base of the wings is placed against the site, the legs press against left ventricular tissue posterior to the anterior leaflet.

[0487] In some implementations, the legs are shaped so that when the base of the wings is placed against the site, the legs press against the fibrous trigone of the left ventricle.

[0488] According to some implementations, a system and / or device (e.g., usable with or for use with a valve of a real or simulated heart, the valve having a first leaflet and an opposing leaflet, the heart having a chamber located upstream from the valve) can include an implant, which can include flexible wings extending from a root portion of the wings to a tip portion of the wings, and / or a restrictor coupled to the wings.

[0489] In some implementations, the implant is configured to be anchored to a site within a heart chamber, ie, the implant is fixed in place such that the wings extend over the first leaflet toward the opposing leaflet and / or deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0490] In some implementations, the limiter prevents the wing from deflecting upstream beyond the deflection limit by providing a counter force when the wing reaches the deflection limit.

[0491] In some implementations, the implant is sterilized.

[0492] In some implementations, the wing frame is laser cut from a piece of sheet metal.

[0493] In some implementations, the frame is shaped to define a buttress at the root of the wing, such that the root of the wing is stiffer than the tip of the wing.

[0494] In some implementations, the implant further includes a pair of arcuate arms, each connected to a wing at a first portion of the arm and configured to contact tissue of the heart chamber at a second portion of the arm when the implant is secured in place.

[0495] In some implementations, the pair of arms form an arc that symmetrically moves away from the wing.

[0496] In some implementations, the pair of arms form an arc that is asymmetrically spaced apart from the wing.

[0497] In some implementations, each arm is coupled to a wing in a manner that allows the arm to pivot relative to the wing.

[0498] In some implementations, the pair of arms form an arc that is asymmetrically spaced away from the wing, such that when the arms pivot relative to one another, they nest within one another.

[0499] In some implementations, each arm defines an anchor receiving member configured to be anchored to a site by advancing an anchor through the anchor receiving member and into tissue of the heart chamber.

[0500] In some implementations, each arm is shaped such that, when the implant is secured in place, each anchor receiving member is positioned adjacent a corresponding commissure of the valve.

[0501] In some implementations, the implant is configured such that when the implant is secured in place by advancing the anchor through the anchor receiving member and into the tissue of the heart chamber, the root portions of the wings maintain contact with the site as the wings deflect in response to the cardiac cycle.

[0502] In some implementations, the implant is configured such that when the implant is secured in place by advancing the anchor through the anchor receiving member and into the tissue of the heart chamber, the angle defined by the arms becomes more acute as the wings deflect upstream.

[0503] In some implementations, the limiter defines a rear stop that is shaped to press against the tissue of the heart chamber when the wings reach their limit of deflection.

[0504] In some implementations, the rear catch is shaped to define an anchor receiving member, and the implant is configured to be secured to the site by advancing an anchor through the anchor receiving member and into tissue at the site.

[0505] In some implementations, the restrictor further defines a plurality of ribs extending along the wing from the aft catch and extending from the root portion of the wing toward the tip portion of the wing.

[0506] In some implementations, when the implant is fixed in place, the limiter prevents the wings from deflecting upstream beyond their deflection limits by providing a counter force from the ribs when the wings reach their deflection limits.

[0507] In some implementations, the limiter defines a pair of arms, each arm forming an arc away from the rear catch.

[0508] In some implementations, each arm defines an anchor receiving member configured to be anchored to a site by advancing an anchor through the anchor receiving member and into tissue of the heart chamber.

[0509] In some implementations, each arm is shaped such that, when the implant is secured in place, each anchor receiving member is positioned adjacent a corresponding commissure of the valve.

[0510] According to some implementations, a system usable with a valve of a real or simulated heart (e.g., the valve can have a first leaflet and an opposing leaflet, and the heart can have a heart chamber located upstream of the valve) includes an anchor and an implant, the implant including wings extending from a base portion of the wings to a tip portion of the wings, and an anchor receiving member located at the base portion of the wings.

[0511] In some implementations, the implant is configured to be anchored to a site within the heart chamber by extending an anchor through the anchor-receiving member and into tissue at the site.

[0512] In some implementations, the system includes a delivery tool including a catheter transluminally advanceable into a chamber of the heart and a shaft disposed within the catheter, the shaft being capable of engaging an implant and configured to deploy the implant from the catheter via engagement with the implant.

[0513] In some implementations, the shaft is configured to position the implant through engagement with the implant at a predetermined location with the anchor receiving member at the site and the wings extending over the first leaflet toward the opposing leaflet.

[0514] In some implementations, an adjustment rod is reversibly coupled to the wings such that, as the anchor extends through the anchor receiving member and into the tissue at the site, axial movement of the adjustment rod adjusts the position of the wings by sliding the anchor receiving member relative to the tissue and anchor.

[0515] In some implementations, the anchor, implant, and delivery tool are sterilized.

[0516] According to some implementations, a system usable with a valve of a real or simulated heart (e.g., the valve can have a first leaflet and an opposing leaflet, and the heart can have a chamber located upstream from the valve) includes an anchor having an anchor head with a diameter and a tissue engaging element extending from the anchor head.

[0517] In some implementations, the system includes an implant, the implant including an anchor receiving member defining an oblong opening defined by a rim, hi some implementations, the implant can be configured to be anchored to the site by seating the anchor head against the rim of the opening when the tissue engaging element extends through the opening into tissue at the site within the heart.

[0518] In some implementations, the opening has a first dimension that is smaller than the diameter and a second dimension that is transverse to the first dimension and larger than the diameter.

[0519] In some implementations, the anchor and implant are sterilized.

[0520] In some implementations, the system includes a delivery tool, the delivery tool including a catheter advanceable transluminally into the heart chamber.

[0521] In some implementations, the system includes a delivery tool including a shaft. In some implementations, the shaft can be engaged to the implant. In some implementations, the shaft can be disposed within a separate catheter.

[0522] In some implementations, the shaft is configured, through engagement with the implant, to (i) deploy the implant from the catheter and / or (ii) position the implant at the site and in a predetermined position where the implant extends over the first leaflet and toward the opposing leaflet.

[0523] In some implementations, an adjustment rod is reversibly coupled to the implant such that as the tissue engaging element extends through the opening into the tissue at the site, axial movement of the adjustment rod adjusts the position of the implant by sliding the implant relative to the tissue and anchor.

[0524] In some implementations, the second dimension is oriented along the length of the implant.

[0525] In some implementations, the implant is configured such that when the tissue engaging element extends through the opening to a first depth in the tissue at the site, the implant is slidable along a second dimension relative to the tissue and anchor.

[0526] In some implementations, when the tissue engaging element extends through the opening to a second, deeper depth in the tissue at the site, the anchor head seats against the rim and / or the implant is no longer slidable relative to the anchor.

[0527] According to some implementations, a system (e.g., a system usable with or for use with a valve of a real or simulated heart) can include an anchor having an anchor head and a tissue engaging element extending from the anchor head.

[0528] In some implementations, the system includes an implant including an implant body, an interface having a diameter, and an anchor receiving member defining an oval opening defined by a rim.

[0529] In some implementations, the opening has a first dimension smaller than the diameter and a second dimension transverse to the first dimension and larger than the diameter. In some implementations, the anchor receiving member is configured to be anchored to a site within the heart by extending a tissue engaging element of the anchor through the interface and the anchor receiving member into tissue at the site.

[0530] In some implementations, the anchor and implant are sterilized.

[0531] In some implementations, the implant is configured to be anchored to the site by seating the interface against the rim of the opening when the tissue engaging element extends through the interface and the opening into tissue at the site.

[0532] In some implementations, the system includes a delivery tool, the delivery tool including a catheter advanceable transluminally into the heart.

[0533] In some implementations, the system includes a delivery tool, the delivery tool including a shaft engaged with the interface. In some implementations, the shaft is configured to (i) deploy the implant from the catheter and / or (ii) position the implant in place with the anchor-receiving member at the site via engagement with the interface. In some implementations, the shaft can be disposed within the catheter.

[0534] In some implementations, an adjustment rod is reversibly coupled to the implant such that axial movement of the adjustment rod adjusts the position of the implant by sliding the implant body and anchor receiving member relative to the tissue and anchor as the tissue engaging element extends through the interface and into the tissue at the site.

[0535] In some implementations, the adjustment rod is reversibly coupled to the implant such that, as the tissue engaging element extends through the interface and into the tissue at the site, axial movement of the adjustment rod adjusts the position of the implant by sliding the implant body and anchor receiving member relative to the interface, tissue, and anchor.

[0536] In some implementations, the interface includes (i) a collar having a diameter and / or (ii) a neck that is narrower than the collar.

[0537] In some implementations, the implant is configured to be anchored to the site by the anchor head seating the collar against the rim of the opening when the anchor receiving member surrounds the neck of the interface.

[0538] In some implementations, the collar is a first collar and the interface further includes a second collar, and / or the implant is configured to be anchored to the site by sandwiching the anchor-receiving member between the first collar and the second collar.

[0539] According to some implementations, a method (e.g., a method usable with or for use with a valve of a real or simulated heart) can include advancing an anchor and an implant into the heart, the anchor including an anchor head and a tissue engaging element extending from the anchor head, and the implant including an anchor receiving member.

[0540] In some implementations, the anchor receiving member defines an oblong opening defined by a rim, the oblong opening having a longitudinal axis.

[0541] In some implementations, the method includes advancing a tissue engaging element of the anchor through the anchor receiving member and into tissue at a site of the heart to a first tissue depth, and sliding the implant along a longitudinal axis relative to the anchor while the tissue engaging element remains within the tissue. The method can then include locking the implant relative to the anchor such that the implant is not slidable relative to the anchor.

[0542] In some implementations, the method further includes sterilizing the anchor and the implant.

[0543] In some implementations, the locking step includes (i) advancing the tissue engaging element of the anchor further through the anchor receiving member and into the tissue at the site to a second tissue depth, and / or (ii) seating the anchor head against the rim.

[0544] According to some implementations, a method usable with a real or simulated heart valve can include advancing an anchor into the heart, the anchor including an anchor head and a tissue-engaging element extending from the anchor head. In some implementations, the method can include advancing an implant into the heart, the implant including an implant body, an interface having a diameter, and an anchor-receiving member defining an oval opening defined by a rim. In some implementations, the oval opening has a major axis.

[0545] In some implementations, the method includes anchoring the implant to the cardiac site by advancing a tissue engaging element of the anchor through the interface and the anchor receiving member into tissue at the cardiac site to a first tissue depth.

[0546] In some implementations, the method can include thereafter locking the implant body relative to the interface by sliding the implant body along the longitudinal axis relative to the interface and / or by advancing a tissue engaging element of the anchor further through the interface and anchor receiving member and into the tissue at the site to a second tissue depth and / or by using the anchor head to seat the interface against the rim.

[0547] In some implementations, the method further includes sterilizing the anchor and the implant.

[0548] In some implementations, the interface includes a first collar and a second collar, and / or the step of seating the interface includes using an anchor head to sandwich the anchor-receiving member between the first collar and the second collar.

[0549] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0550] According to some implementations, a method usable with a valve of a real or simulated heart can include advancing an anchor into the heart, the anchor including an anchor head and a tissue engaging element extending from the anchor head.

[0551] In some implementations, the method can include advancing an implant into the heart, the implant including an implant body, an interface having a diameter, and / or an anchor receiving member defining an oval opening defined by a rim, the oval opening having a longitudinal axis.

[0552] In some implementations, the method includes anchoring the implant to the cardiac site by advancing a tissue engaging element of the anchor through the interface and the anchor receiving member into tissue at the cardiac site to a first tissue depth.

[0553] In some implementations, the method can include thereafter locking the implant body relative to the interface by sliding the implant body along the longitudinal axis relative to the interface and / or by advancing a tissue engaging element of the anchor further through the interface and anchor receiving member and into the tissue at the site to a second tissue depth and / or by using the anchor head to seat the interface against the rim.

[0554] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0555] According to some implementations, the system can be used with a valve of a real heart or a simulated heart, for example, the valve can have a first leaflet and an opposing leaflet, and the heart can have a heart chamber located upstream of the valve. In some implementations, the system can include an implant, the implant being a wing extending from a root portion of the wing to a tip portion of the wing, and / or an interface located at the root portion of the wing. In some implementations, the interface can be configured to be anchored to a site within the heart chamber.

[0556] In some implementations, the bulking element can be coupled (e.g., fixedly coupled, connected, etc.) to a portion of the wing (e.g., a tip portion of the wing, a middle portion of the wing, a proximal portion of the wing, a distal portion of the wing, etc.).

[0557] In some implementations, the system includes a delivery tool that can include a catheter transluminally advanceable into the heart chamber and a shaft disposed within the catheter.

[0558] In some implementations, the shaft is configured to engage the interface and deploy the implant from the catheter via engagement with the interface, and / or to position the implant in a predetermined position where the interface is located at the site and the wings extend over the first leaflet and the tip portion is disposed between the first and opposing leaflets.

[0559] In some implementations, the system includes an actuator operatively coupled to the bulking element, and actuation of the actuator can change the bulkiness of the tip portion.

[0560] In some implementations, the implant and delivery tool are sterilized.

[0561] In some implementations, the actuator is externally controllable to transition the bulking element from a delivery state to an actuation state.

[0562] In some implementations, the bulking element includes a braided structure, the braided structure having a delivery state and an actuation state, and / or transitioning from the delivery state to the actuation state causes the braided structure to become shorter and wider.

[0563] According to some implementations, a method (e.g., a method usable with or for use with a valve of a real or simulated heart, the valve having a first valve leaflet and an opposing valve leaflet, the heart having a first heart chamber located upstream from the valve and a second heart chamber located downstream from the valve) can include advancing a shaft and / or implant within a catheter into the first heart chamber, the implant including an interface engaged with a distal end of the shaft and / or flexible wings coupled to the interface.

[0564] In some implementations, the wing extends from a root portion of the wing to a tip portion of the wing, and the bulking element is coupled (e.g., fixedly coupled, connected, etc.) to the wing (e.g., to the tip portion of the wing, to a mid-region of the wing, to an end of the wing, to a distal portion of the wing, to a proximal portion of the wing, etc.).

[0565] In some implementations, the shaft can be used to deploy the implant from the catheter into the first heart chamber and / or anchor the implant in place with the interface located at a site within the first heart chamber and the wings extending over the first leaflet toward the opposing leaflet, the wings deflecting upstream and downstream in a reciprocating manner in direct response to the cardiac cycle of the heart.

[0566] In some implementations, the actuator can be used to drive the bulking element in a manner that changes the bulk of the implant (e.g., tip portion, middle portion, end portion, distal portion, proximal portion, etc.).

[0567] In some implementations, the method further includes sterilizing the catheter, shaft, and implant.

[0568] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0569] According to some implementations, a system (e.g., a system usable with or for use with a valve of a real or simulated heart) can include an implant that can be configured to be implanted transluminally within the heart. In some implementations, the implant can include wings that are wings and extend from a wing root portion to a wing tip portion and / or a shape memory member coupled to the wings.

[0570] In some implementations, the shape memory member is configured to be heated within the heart to a temperature greater than 40°C.

[0571] In some implementations, the wings are configured to be resized to a predetermined size by temporarily heating the shape memory member to a temperature, and the wings are configured to retain the predetermined size after the temporary heating is stopped.

[0572] In some implementations, the implant is sterilized.

[0573] In some implementations, the wings are configured to temporarily heat the shape memory member to a temperature that changes the shape of the shape memory member, thereby resizing the wings.

[0574] In some implementations, the implant includes a power source configured to heat the shape memory member.

[0575] In some implementations, the implant further includes an antenna configured to wirelessly receive power to heat the shape memory member.

[0576] According to some implementations, a system usable with a valve of a real or simulated heart (e.g., the valve can have a first leaflet and an opposing leaflet, and the heart can have a chamber located upstream of the valve) can include an implant, the implant including wings extending from a base portion of the wing to a tip portion of the wing, an interface located at the base portion of the wing, and / or a shape memory member.

[0577] In some implementations, the shape memory member is bonded to the wings and / or configured to permanently change the size of the wings by temporarily heating the shape memory member.

[0578] In some implementations, the system includes an anchor and a delivery tool, where the delivery tool can include a catheter transluminally advanceable into the heart chamber and a shaft disposed within the catheter.

[0579] In some implementations, the shaft can engage the interface and can be configured to deploy the implant from the catheter via this engagement, and / or can be configured to position the implant in a predetermined position where the interface is located at a site upstream from the valve and the wings extend over the first leaflet toward the opposing leaflet.

[0580] In some implementations, the delivery tool includes a driver that engages the anchor, the driver configured to anchor the interface to cardiac tissue at the site by securing the implant in place using the anchor. In some implementations, the delivery tool can be electrically connected to the shape memory member and / or can be configured to electrically heat the shape memory member via the electrical connection.

[0581] In some implementations, the implant, anchor, and delivery tool are sterilized.

[0582] In some implementations, the implant is configured to temporarily heat the shape memory member to change the shape of the shape memory member, thereby permanently changing the size of the wings.

[0583] In some implementations, the implant is configured to change the shape of the shape memory member by heating the shape memory member.

[0584] In some implementations, the implant includes a locking member configured to transition between (i) a locked state in which a shape change of the shape memory member does not change the size of the wings, and / or (ii) an unlocked state in which a shape change of the shape memory member changes the size of the wings.

[0585] According to some implementations, a system (e.g., a system usable with or for use with a valve of a real or simulated heart) can include an implant, an anchor, and / or a delivery tool. In some implementations, the implant can include an interface. In some implementations, the anchor can include an anchor head and / or a tissue-engaging element. In some implementations, the tissue-engaging element can extend from the anchor head.

[0586] In some implementations, the delivery tool can include a catheter, a shaft, and / or a driver. The catheter can be transluminally advanceable into the heart.

[0587] In some implementations, the shaft may be positioned within the catheter with a distal end portion of the shaft engaged with the interface, and through that engagement, the implant may be configured to (i) deploy from the catheter and / or (ii) position the implant such that the interface is disposed at a site within the heart.

[0588] In some implementations, the driver can be engageable with or can engage with an anchor and can be configured to use the anchor to secure the implant at the site, thereby anchoring the interface to cardiac tissue at the site.

[0589] In some implementations, the distal segment of the shaft can have (i) a rigid state and (ii) a flexible state in which the distal segment is more flexible than when it is in the rigid state, and / or can be transitionable between the rigid state and the flexible state while the distal end portion remains connected to the interface.

[0590] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0591] In some implementations, the shaft defines a shaft lumen, and in some implementations, a driver can be slidably advanceable through the shaft lumen such that a drive head of the driver engages with the anchor head.

[0592] In some implementations, the driver can include a drive shaft that is more flexible than a distal segment of the shaft when the distal segment is in a rigid state.

[0593] In some implementations, the distal segment has an outer diameter that is no more than 10 percent larger than the outer diameter of the proximal portion of the shaft.

[0594] In some implementations, the distal segment of the shaft can include a spring that can be transitioned between a rigid state and a flexible state by varying the tension of the spring.

[0595] In some implementations, the distal segment of the shaft includes a tether, and the distal segment can be transitionable between a rigid state and a flexible state by varying the tension on the tether.

[0596] In some implementations, the distal segment of the shaft is transitionable between a rigid state and a flexible state while the driver remains engaged with the anchor.

[0597] In some implementations, the distal segment of the shaft is transitionable between a rigid state and a flexible state, with the interface anchored to the cardiac tissue at the site.

[0598] In some implementations, the distal segment of the shaft includes a hinge, and the distal segment can be transitionable between a rigid state and a flexible state by adjusting the articulation of the hinge.

[0599] In some implementations, the system is configured such that transitioning the distal segment from a rigid state to a flexible state increases the range of articulation of the hinge along the articulation axis.

[0600] In some implementations, the hinge is a first hinge and the articulation axis is a first articulation axis, hi some implementations, the distal segment can further include a second hinge configured to articulate along a second articulation axis that is non-parallel to the first articulation axis.

[0601] In some implementations, the distal segment is configured such that transitioning from a rigid state to a flexible state increases a second range of articulation of the hinge along a second axis of articulation.

[0602] In some implementations, the second joint movement axis is orthogonal to the first joint movement axis.

[0603] In some implementations, the distal segment is transitionable between a rigid state and a flexible state by moving an anchor longitudinally through the distal segment.

[0604] In some implementations, the distal segment is transitionable from a rigid state to a flexible state by anchoring the interface to cardiac tissue at a site.

[0605] According to some implementations, a method usable with a valve of a real or simulated heart can include advancing an implant including an interface into a heart using a catheter. In some implementations, the implant can be deployed from a distal opening of the catheter using a shaft, with a distal end portion of the shaft coupled to the interface.

[0606] In some implementations, a driver that engages the anchor can be used to drive the anchor into the tissue, thereby anchoring the interface to the tissue at the heart site.

[0607] In some implementations, following the deploying step, the distal segment of the shaft can be transitioned from a rigid state to a flexible state in which the distal segment is more flexible compared to when it was in the rigid state, while the distal end portion of the shaft remains coupled to the interface.

[0608] In some implementations, the method can further include subsequently disengaging the driver from the anchor and / or disengaging the distal end portion of the shaft from the interface.

[0609] In some implementations, the transitioning step occurs after the anchoring step.

[0610] In some implementations, the distal segment of the shaft includes a docking station at which the distal end portion of the shaft is reversibly coupled to the proximal portion of the shaft, and / or the transitioning step includes transitioning the distal segment of the shaft from a rigid state to a flexible state by decoupling the distal end portion of the shaft from the proximal portion of the shaft.

[0611] In some implementations, the shaft includes a tether, and / or the transitioning step includes transitioning the distal segment of the shaft from a rigid state to a flexible state by reducing tension on the tether to decouple the distal end portion of the shaft from the proximal portion of the shaft.

[0612] In some implementations, the method further includes, prior to the disengaging step, reconnecting the distal end portion of the shaft to the proximal portion of the shaft by increasing tension on the tether.

[0613] In some implementations, the method further includes sterilizing the implant, the shaft, and the catheter.

[0614] In some implementations, the shaft includes a tether, and the transitioning step can include transitioning the distal segment from a rigid state to a flexible state by adjusting tension on the tether.

[0615] In some implementations, the distal segment of the shaft includes a spring, and the transitioning step can include transitioning the distal segment from the rigid state to the flexible state by adjusting the tension of the spring.

[0616] In some implementations, the method further includes, prior to the anchoring step, using the shaft to position the interface at the site prior to anchoring the interface to the tissue.

[0617] In some implementations, the positioning step includes positioning the interface at the site when the distal segment of the shaft is in a rigid state.

[0618] In some implementations, the method further includes, after the anchoring step, transitioning the distal segment from the flexible state to the rigid state again and / or withdrawing the shaft and driver from the subject.

[0619] In some implementations, the method further includes assessing valve function prior to the remigrating step.

[0620] In some implementations, the evaluating step occurs before the disengaging step.

[0621] In some implementations, the evaluating step occurs before the unbinding step.

[0622] In some implementations, the site is a first site, and / or the method further includes, in response to the evaluating step, (i) using a driver to remove the anchor from the tissue at the first site, (ii) using the shaft to redeploy the implant to a second site in the heart, and / or (iii) using a driver to drive the anchor into the tissue at the second site in the heart, thereby anchoring the interface to the tissue at the second site.

[0623] In some implementations, the method further includes the re-migrating step occurring before the re-anchoring step.

[0624] In some implementations, the transitioning step includes transitioning the distal segment from the rigid state to the flexible state by driving anchors through the interface and into tissue.

[0625] In some implementations, the distal segment includes a hinge. In some implementations, the transitioning step can include increasing a range of articulation of the hinge along the articulation axis.

[0626] In some implementations, the hinge is a first hinge having a first range of articulation along a first axis of articulation, and the distal segment further includes a second hinge having a second range of articulation along a second axis of articulation, hi some implementations, the transitioning step can further include increasing the second range of articulation of the second hinge.

[0627] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0628] According to some implementations, a method (e.g., a method usable with or for use with a valve of a real or simulated heart of a subject (e.g., a live subject or a simulation)) can include advancing an implant including an interface into the heart using a catheter. In some implementations, the method can include deploying the implant from a distal opening of the catheter using a shaft having a distal end portion coupled to the interface.

[0629] In some implementations, the interface can be anchored to tissue at a cardiac site by using a driver that engages the anchor to drive the anchor into the tissue.

[0630] In some implementations, the method may further include, after the deploying step, (i) transitioning the distal segment of the shaft from a rigid state to a flexible state in which the distal segment is more flexible than when the distal segment was in the rigid state, while the distal end portion of the shaft remains coupled to the interface, and / or (ii) thereafter (a) disengaging the driver from the anchor and / or (b) uncoupling the distal end portion of the shaft from the interface.

[0631] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0632] According to some implementations, a system usable with a valve of a real or simulated heart (e.g., the valve has a first leaflet and an opposing leaflet, and the heart has a chamber located upstream from the valve) can include an implant, an anchor, and / or a delivery tool.

[0633] In some implementations, the implant can include wings and / or interfaces, hi some implementations, the wings can extend from a wing root portion to a wing tip portion.

[0634] In some implementations, the interface can be located at the root portion of the wing. In some implementations, the interface can be located at an edge of the implant (e.g., the upper edge, the proximal edge, etc.).

[0635] In some implementations, the anchor can be rotatably coupled to the interface and axially fixed, hi some implementations, the anchor can include an anchor head and / or a tissue engaging element extending from the anchor head to define an anchor axis of the anchor.

[0636] In some implementations, the delivery tool can include a catheter, a shaft, and / or a driver. The catheter can be transluminally advanceable into the heart chamber.

[0637] In some implementations, the shaft may be disposed within a catheter and may engage with the interface, which engagement may be configured to (i) deploy the implant from the catheter and / or (ii) position the implant in a predetermined position where the interface is located at a site upstream of the valve and the wings extend over the first leaflet toward the opposing leaflet.

[0638] In some implementations, the driver can be configured to engage an anchor and use the anchor to secure the implant in place, thereby anchoring the interface to cardiac tissue at the site.

[0639] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0640] According to some implementations, a system (e.g., a system usable with or for use with a real or simulated heart, whether real or simulated) can include an implant, an anchor, and / or a delivery tool.

[0641] In some implementations, the implant can include an interface, an anchor receiving member, and / or wings coupled to the interface and the anchor receiving member.

[0642] In some implementations, the delivery tool can include a catheter, a shaft, and / or a driver. The catheter can be transluminally advanceable into the heart and can define a distal opening and a lateral opening.

[0643] In some implementations, the shaft may be disposed within the catheter and may be engaged with the interface, through which engagement may be configured to (i) deploy the implant from a distal opening of the catheter and / or (ii) position the implant such that the anchor receiving member is disposed at a site in the heart.

[0644] In some implementations, the driver can be engaged with the anchor and configured to secure the implant to the heart by (i) advancing the anchor from the side opening of the catheter toward the anchor receiving member, and / or (ii) driving the anchor through the anchor receiving member and into the tissue of the heart at the site.

[0645] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0646] In some implementations, the implant has a compressed state and an expanded state. In some implementations, the implant includes a flexible frame that includes a shape memory material and biases the implant toward the expanded state. In some implementations, the implant and / or frame can be actuated (e.g., mechanically actuated, etc.) to cause the implant and / or frame to expand to the expanded state.

[0647] In some implementations, the implant can include an expansion element having (i) a compact state and / or (ii) an extended state in which the expansion element resists compression of the implant toward the compressed state.

[0648] In some implementations, the catheter is configured to accommodate the implant when the implant is in a compressed state and the expansion element is in a compact state.

[0649] In some implementations, the shaft is configured to deploy the implant from the distal opening of the catheter via engagement, thereby placing the implant in an expanded state and the expansion element in an extended state within the heart.

[0650] In some implementations, the implant is configured such that an expansion force is applied to the implant by extension of the expansion element from a compact state to an extended state, the expansion force facilitating expansion of the implant from the compressed state to the expanded state.

[0651] In some implementations, the expansion element is configured to resist transitioning from the extended state towards the compact state.

[0652] In some implementations, the expansion element includes a spring.

[0653] In some implementations, the expandable element includes multiple subunits, and the expandable element is configured such that the subunits interlock with one another as the expandable element extends to the extended state.

[0654] In some implementations, the expansion element includes multiple sub-units that are configured to lock together when the expansion element is in the extended state.

[0655] In some implementations, the expansion element is straighter in the extended state compared to the compact state.

[0656] In some implementations, the expansion element includes a hinge, and the expansion element can be configured such that straightening the hinge straightens the expansion element.

[0657] In some implementations, the delivery tool further includes an expansion actuator configured to transluminally extend the expansion element from the compact state to the extended state.

[0658] In some implementations, the anchor is a first anchor and the system further includes a second anchor. The anchor receiving member can be a first anchor receiving member and the implant further includes a second anchor receiving member.

[0659] In some implementations, the driver is a first driver and the delivery tool can further include a second driver. In some implementations, the lateral opening is a first lateral opening and the catheter can further define a second lateral opening opposite the first lateral opening.

[0660] In some implementations, each of the first and second drivers can engage a corresponding anchor and can be configured to secure the implant to the heart by (i) advancing it through one of the side openings toward one of the anchor receiving members and / or (ii) driving one of the first and second anchors through one of the anchor receiving members and into the tissue of the heart at the site.

[0661] In some implementations, the first driver and the second driver are configured to diverge from one another when the first driver and the second driver are advanced through one of the side openings toward the anchor receiving member.

[0662] In some implementations, the catheter further includes a gate at the side opening, the gate comprising a shape-memory material. In some implementations, the catheter can be configured to transition between (i) a delivery state in which the gate is closed, and / or (ii) a deployed state in which the gate is open.

[0663] In some implementations, the system is configured to facilitate transition of the catheter from the delivery state to the deployed state by deploying the implant from the distal opening.

[0664] In some implementations, the catheter is configured such that when the catheter is deployed, an open gate guides the driver and anchor out of a side opening in the catheter toward the anchor receiving member.

[0665] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart, e.g., of a live subject or a simulation) can include advancing an implant compressed within a catheter into the heart. In some implementations, the implant can include an interface, an anchor receiving member, and / or wings coupled to the interface and the anchor receiving member.

[0666] In some implementations, a shaft coupled to the interface can be used to deploy the implant from a distal opening in the catheter, with the wings expanding inside the heart.

[0667] In some implementations, a driver can be used to (i) advance an anchor through a side opening in the catheter into the anchor receiving member, and / or (ii) drive a tissue engaging element of the anchor through the anchor receiving member and into the tissue, thereby anchoring the implant to the cardiac tissue.

[0668] In some implementations, the method further includes sterilizing the implant and the catheter.

[0669] In some implementations, the deploying step includes deploying the implant from a distal opening of the catheter in a direction generally parallel to the longitudinal axis of the distal portion of the shaft, hi some implementations, the advancing step includes advancing the anchor from a side opening of the catheter in a direction oblique to the longitudinal axis of the distal portion of the shaft.

[0670] In some implementations, the driver is a first driver, the lateral opening is a first lateral opening of the catheter, the anchor receiving member is a first anchor receiving member, and the implant further includes a second anchor receiving member.

[0671] In some implementations, the advancing step can include using a first driver and a second driver to (i) advance a first anchor from a first side opening of the catheter into the first anchor receiving member, and / or (ii) advance a second anchor from a second side opening of the catheter into the second anchor receiving member.

[0672] In some implementations, the anchoring step can include anchoring the implant to the cardiac tissue by driving each anchor through a corresponding anchor-receiving member into the cardiac tissue.

[0673] In some implementations, the advancing step includes divergently advancing the first driver and the second driver away from one another.

[0674] In some implementations, the catheter further includes a shape memory gate at the side opening, hi some implementations, the catheter can be transitioned from a delivery state with the gate closed to a deployed state with the gate open.

[0675] In some implementations, the transitioning step includes transitioning the catheter from the delivery state to the deployed state by deploying the implant from a distal opening of the catheter.

[0676] In some implementations, the transitioning step includes transitioning the catheter from the delivery state to the deployed state by proximally retracting a driver within the catheter.

[0677] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0678] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart, e.g., of a living subject or a simulation) can include advancing an implant compressed within a catheter into the heart, the implant including (i) an interface, (ii) an anchor receiving member, and / or (iii) wings coupled to the interface and the anchor receiving member.

[0679] In some implementations, the method can include deploying the implant from a distal opening of the catheter using a shaft coupled to the interface so that the wings expand inside the heart.

[0680] In some implementations, the method can include using a driver to (i) advance an anchor through a side opening in the catheter and into the anchor receiving member, and / or (ii) anchor the implant to the tissue by driving a tissue engaging element of the anchor through the anchor receiving member and into the tissue of the heart.

[0681] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0682] According to some implementations, a system (e.g., a system usable with or for use with a real or simulated heart, of a live subject or a simulation) can include an implant, anchor, catheter, latch, shaft, driver, and / or insert.

[0683] In some implementations, the implant can include an interface. The catheter can be transluminally advanceable into the heart.

[0684] In some implementations, the shaft (i) can be positioned inside the catheter, (ii) can be reversibly engaged to the interface via a latch, and / or (iii) can be configured to, via engagement, (a) deploy the implant from the catheter and / or (b) position the implant at a predetermined location where the interface is located at a cardiac site.

[0685] In some implementations, a driver may be disposed within the catheter and configured to anchor the implant in place by driving the anchor into tissue at the site.

[0686] In some implementations, an insert can be disposed between the shaft and the interface and can be slidable in a manner that displaces a latch to disengage the shaft from the interface.

[0687] In some implementations, at least one of the implant, anchor, catheter, and shaft is sterile.

[0688] In some implementations, the shaft is shaped to define a latch.

[0689] In some implementations, the driver is shaped to define the insert.

[0690] In some implementations, the driver is configured to anchor the implant in place by driving the anchor through the interface and into tissue at the site.

[0691] In some implementations, the system is configured so that the driver extends distally through the shaft from outside the subject to the interior of the catheter.

[0692] In some implementations, the interface is shaped to define a window. In some implementations, the system can be configured such that the latch is disposed within the window when the shaft is engaged with the interface. In some implementations, the insert can be slidable such that displacing the latch from the window disengages the shaft from the interface.

[0693] In some implementations, the anchor defines an anchor head and a helical tissue-engaging element extending along the anchor axis and away from the anchor head.

[0694] In some implementations, the system is configured such that the insert is rotatable about the anchor axis relative to the latch in a manner that displaces the latch, thereby disengaging the shaft from the interface.

[0695] In some implementations, the system is configured such that the insert is slidable along the anchor axis relative to the latch in a manner that displaces the latch, thereby disengaging the shaft from the interface.

[0696] In some implementations, the latch comprises a shape memory material having a compressed shape and a relaxed shape. In some implementations, the insert can be slidable such that transitioning the latch between the compressed and relaxed shapes decouples the shaft from the interface. In some implementations, the insert can be slidable such that decoupling the latch from the interface decouples the shaft from the interface.

[0697] In some implementations, the insert includes an intervening tube disposed between the shaft and the interface.

[0698] In some implementations, the interposer tube is slidable relative to the shaft and the interface.

[0699] In some implementations, the interstitial tube surrounds a portion of the driver.

[0700] In some implementations, the interposition tube surrounds a portion of the anchor.

[0701] In some implementations, the interstitial tube surrounds a portion of the interface.

[0702] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart, e.g., of a living subject or a simulation) can include advancing into the heart (i) an anchor, (ii) an implant defining an interface, (iii) a catheter containing the implant, (iv) a latch, (v) a shaft reversibly engaging the interface via the latch, and / or (vi) an insert disposed between the shaft and the interface. In some implementations, the implant can be deployed from the catheter.

[0703] In some implementations, the shaft can be used to position the implant so that the interface is located at the site of the heart.

[0704] In some implementations, a driver can be used to drive a portion of the anchor through the interface and into the tissue at the site to secure the implant in place, after which the shaft can be disengaged from the implant by sliding an insert between the shaft and the interface.

[0705] In some implementations, the method further includes sterilizing the implant, the anchor, the shaft, and the catheter.

[0706] In some implementations, the disengaging step includes displacing the latch from the interface.

[0707] In some implementations, the interface is shaped to define a window, and the disengaging step can include displacing the latch from within the window.

[0708] In some implementations, the latch can include a shape memory material having a compressed shape and a relaxed shape, and the disengaging step can include displacing the latch from the interface by sliding an insert between the shaft and the interface in a manner that allows the latch to transition between the compressed and relaxed shapes.

[0709] In some implementations, the disengaging step includes displacing the latch from the interface by sliding an insert between the shaft and the interface in a manner that causes the latch to expand laterally relative to the interface.

[0710] In some implementations, the anchor defines an anchor head and / or an anchor shaft along which the helical tissue-engaging element extends from the anchor head, hi some implementations, the disengaging step can include displacing the latch from the interface by sliding the insert relative to the latch along the anchor shaft.

[0711] In some implementations, the anchor defines an anchor head and / or an anchor shaft along which extends a helical tissue-engaging element from the anchor head.

[0712] In some implementations, the disengaging step can include displacing the latch from the interface by rotating the insert relative to the latch about an anchor axis.

[0713] In some implementations, the anchor is a first anchor, the interface is a first interface, and the implant further includes a second interface, the second interface defining a longitudinal axis along which the second interface can be configured to receive the second anchor.

[0714] In some implementations, the latch can be a first latch, the shaft can be a first branch of the shaft, and / or the insert can be a first insert.

[0715] In some implementations, the method may further include advancing into the heart (i) a second anchor, (ii) a second latch, (iii) a second branch of the shaft reversibly engaged to the second interface via the second latch, and / or (iv) a second insert disposed between the second branch of the shaft and the second interface.

[0716] In some implementations, the disengaging step can include disengaging the shaft from the implant by (a) rotating the first insert relative to the first latch in a first orientation about a longitudinal axis of the first interface, and / or (b) rotating the second insert relative to the second latch in an opposite second orientation about a longitudinal axis of the second interface.

[0717] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0718] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart, e.g., of a living subject or a simulation) can include advancing into the heart (i) an anchor, (ii) an implant defining an interface, (iii) a catheter containing the implant, (iv) a latch, (v) a shaft reversibly engaging the interface via the latch, and / or (vi) an insert disposed between the shaft and the interface. The method can include deploying the implant from the catheter.

[0719] In some implementations, the method can include using the shaft to position the implant such that the interface is disposed at the site of the heart.

[0720] In some implementations, the method can include using a driver to drive a portion of the anchor through the interface and into tissue at the site, thereby securing the implant in place.

[0721] In some implementations, the method can then include disengaging the shaft from the implant by sliding an insert between the shaft and the interface.

[0722] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0723] In some implementations, a system (e.g., a system usable with or for use with a valve of a real or simulated heart of a subject (e.g., a live subject or a simulation), e.g., the valve has a first leaflet and an opposing leaflet, and the heart has a heart chamber located upstream from the valve) can include an anchor and / or an implant.

[0724] In some implementations, the implant can include wings and / or anchor receiving members. In some implementations, the wings can extend from a wing root portion to a wing tip portion.

[0725] In some implementations, the anchor-receiving member can be configured to promote tissue ingrowth onto the upper surface.

[0726] In some implementations, the anchor receiving member can be coupled to a root portion of the wing (e.g., at or near the edge of the implant or at another location) such that anchoring the anchor receiving member to the valve annulus positions the wing such that (i) the wing extends over the first leaflet toward the opposing leaflet, and / or (ii) the wing deflects upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0727] In some implementations, the implant can define an obstacle that can be configured to block tissue ingrowth from proceeding from the anchor-receiving member toward the tip portion of the wing.

[0728] In some implementations, at least one of the implant and the anchor is sterilized.

[0729] In some implementations, the wing defines a contact surface and an opposing surface opposite the contact surface. In some implementations, the obstacle can include a cage.

[0730] In some implementations, a cage is disposed at the root portion of the wing on the opposite surface, hi some implementations, the cage can include a barrier configured to mechanically inhibit tissue ingrowth from proceeding from the anchor-receiving member toward the tip portion of the wing.

[0731] In some implementations, the barrier is a bilayer barrier, the bilayer barrier including an interface opposing layer including a material that promotes tissue ingrowth onto an upper surface, hi some implementations, the bilayer barrier can include an opposing layer including a material that inhibits tissue ingrowth onto an upper surface.

[0732] In some implementations, the cage defines a rear catch portion that is configured to abut and press against tissue of the heart chamber when the anchor-receiving member is anchored to the annulus.

[0733] In some implementations, the obstruction is configured to prevent tissue ingrowth from proceeding from the anchor-receiving member toward the tip portion of the wing by reducing contact between the root portion of the wing and the first leaflet.

[0734] In some implementations, the wings are shaped to define an obstruction such that a root portion of the wing curves upstream, away from the first leaflet, when the anchor-receiving member is anchored to the annulus, and a tip portion of the wing can curve downstream, toward the first leaflet.

[0735] In some implementations, the wing defines a contact surface and an opposing surface opposite the contact surface, hi some implementations, the obstruction can include a raised platform attached to the contact surface at a root portion of the wing, the raised platform configured to prevent contact between the root portion of the wing and the first leaflet as the wing extends over the first leaflet toward the opposing leaflet.

[0736] According to some implementations, a system (e.g., a system usable with or for use with a real or simulated heart of a subject (e.g., a live subject or a simulation)) can include an implant and / or an anchor. In some implementations, the implant can include an anchor-receiving member.

[0737] In some implementations, the anchor can include an anchor head and / or a helical tissue-engaging element extending distally from the anchor head along the anchor shaft, the helical tissue-engaging element configured to be threaded through the anchor receiving member and into tissue by rotating the anchor head in a rotational orientation, at least until the anchor head reaches the anchor receiving member.

[0738] In some implementations, the anchor head and anchor receiving member can be shaped such that when the anchor head reaches the anchor receiving member, further rotation of the anchor head in the rotational direction causes the anchor receiving member to be pushed distally against the anchor.

[0739] In some implementations, at least one of the implant and the anchor is sterilized.

[0740] In some implementations, the system can further include a delivery tool including a catheter transluminally advanceable into the heart and a shaft disposed within the catheter, the distal end portion of the shaft engaging the implant and configured through the engagement to (i) deploy the implant from the catheter and / or (ii) position the implant such that the interface is disposed at a site within the heart.

[0741] In some implementations, the delivery tool can include a driver configured to anchor the anchor-receiving member to cardiac tissue at the site by using the anchor to secure the implant at the site.

[0742] In some implementations, the anchor head and anchor receiving member are shaped such that when the anchor head reaches the anchor receiving member, further rotation of the anchor head in the rotational direction pushes the anchor head proximally away from the anchor receiving member.

[0743] In some implementations, the anchor head and anchor receiving member are each shaped to define complementary contoured surfaces where the anchor head and anchor receiving member interact.

[0744] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart of a subject (e.g., a live subject or a simulation)) can include advancing into the heart (i) an anchor including an anchor head and a tissue-engaging portion extending from the anchor head, and / or (ii) an implant compressed within a catheter and including an anchor-receiving member.

[0745] In some implementations, a shaft coupled to the anchor receiving member can be used to position the anchor receiving member at a site in the heart and deploy the implant from a distal opening in the catheter.

[0746] In some implementations, a driver can be used to rotate the anchor head at least until the anchor head reaches the anchor receiving member, thereby threading the anchor through the anchor receiving member and into the tissue at the site.

[0747] In some implementations, after the anchor head reaches the anchor receiving member, the anchor head can be further rotated to push the anchor receiving member into the tissue at the site.

[0748] In some implementations, the method further includes sterilizing the shaft, the anchor, and the implant.

[0749] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0750] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart of a subject (e.g., a live subject or a simulation)) can include advancing into the heart (i) an anchor including an anchor head and a tissue-engaging portion extending from the anchor head, and / or (ii) an implant compressed within a catheter and including an anchor-receiving member.

[0751] In some implementations, the method can include deploying the implant from a distal opening of the catheter using a shaft coupled to the anchor receiving member such that the anchor receiving member is positioned at the site of the heart.

[0752] In some implementations, the method can include using a driver to rotate the anchor head at least until the anchor head reaches the anchor receiving member to thread the anchor through the anchor receiving member and into tissue at the site.

[0753] In some implementations, the method can include, after the anchor head reaches the anchor receiving member, further rotating the anchor head to push the anchor receiving member into the tissue at the site.

[0754] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0755] According to some implementations, a system (e.g., a system usable with or for use with a real or simulated heart of a subject (e.g., a live subject or a simulation)) can include an implant. In some implementations, the implant can include a frame and an interface, where the interface includes (i) a first collar configured to interact with the anchor head, (ii) a second collar, and / or (iii) a neck portion connecting the first collar and the second collar, the neck portion extending through the loop portion of the frame.

[0756] In some implementations, the interface can have a relaxed state in which the loop portion is loosely coupled to the interface.

[0757] In some implementations, the interface can have a tight fit in which the loop portion is sandwiched between the first collar and the second collar.

[0758] In some implementations, the implant is sterilized.

[0759] In some implementations, the system further includes an anchor, and the interface can be configured to transition from the relaxed state to the compacted state by advancing the anchor distally through the interface.

[0760] In some implementations, the anchor includes an anchor head and a tissue engaging portion extending along the anchor shaft and spaced from the anchor head.

[0761] In some implementations, the system is configured such that when the interface is in a relaxed state, at least a portion of the tissue engaging portion protrudes distally through the interface.

[0762] In some implementations, the anchor includes an anchor head and a tissue engaging portion extending along the anchor shaft and spaced from the anchor head.

[0763] In some implementations, the interface is configured to transition from the relaxed state to the compact state by advancing the tissue engaging portion distally through the interface, whereby (i) the anchor head abuts and presses distally against the interface, and / or (ii) the tissue engaging portion passes distally through the interface.

[0764] In some implementations, the system is configured to reduce the likelihood of deflection of the implant along the anchor axis as the interface transitions from a relaxed state to a tight state.

[0765] In some implementations, the system can include a delivery tool that includes (i) a catheter that is transluminally advanceable to the site; and (ii) a shaft disposed within the catheter, the shaft having a distal end portion that engages the interface and that is configured, via the engagement, to (a) deploy the implant from the catheter and / or (b) position the implant such that the interface is disposed at the tissue site.

[0766] In some implementations, the delivery tool can also include a driver configured to (i) secure the implant at the site and / or (ii) advance an anchor distally through the interface, thereby transitioning the interface from a relaxed state to a tight state.

[0767] In some implementations, the system is configured such that the drive head engages the anchor head when the interface is in a relaxed state, hi some implementations, the system is configured such that the shaft engages the interface when the interface is in a relaxed state.

[0768] In some implementations, the interface can be configured to transition from a relaxed state to a tight state when the drive head remains engaged with the anchor head. In some implementations, the interface can be configured to transition from a relaxed state to a tight state when the shaft remains engaged with the interface.

[0769] In some implementations, the system is configured such that when the interface is in a relaxed state, the implant is deflectable relative to the interface along an evaluation deflection range that is generally equal to the deployed deflection range through which the implant is deflectable when the system is configured in a deployed state in which (i) the interface is in a tight state and / or (ii) the shaft is disengaged from the interface.

[0770] According to some implementations, a method (e.g., a method usable with or for use in real or simulated tissue of a subject (e.g., a living subject or a simulation)) can include advancing an anchor and / or an implant including a frame and an interface to a site in the tissue using a catheter.

[0771] In some implementations, the interface can include (i) a first collar configured to interact with the anchor head, (ii) a second collar, and / or (iii) a neck portion connecting the first collar and the second collar and extending through the loop portion of the frame.

[0772] In some implementations, a driver can be used to transition the interface from a relaxed state, in which the loop portion is loosely coupled to the interface, to a tight state, in which the loop portion is sandwiched between the first and second collars.

[0773] In some implementations, the method further includes sterilizing the anchor and the implant.

[0774] In some implementations, the anchor includes an anchor head and a tissue engaging portion extending along the anchor shaft and spaced from the anchor head.

[0775] In some implementations, the transitioning step can include transitioning the interface from a relaxed state to a tight state by advancing an anchor through the interface and into the tissue at the site.

[0776] In some implementations, the transitioning step includes transitioning the interface from a relaxed state to a compact state such that the anchor head abuts and presses distally against the interface.

[0777] In some implementations, the transitioning step includes reducing the likelihood of deflection of the implant along the anchor axis.

[0778] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0779] According to some implementations, a method (e.g., a method usable with or for use with real or simulated tissue of a subject (e.g., a live subject or a simulation)) can include advancing an anchor and / or implant to a site in the tissue using a catheter. In some implementations, the implant can include a frame and an interface.

[0780] In some implementations, the interface can include (i) a first collar configured to interact with the anchor head, (ii) a second collar, and / or (iii) a neck portion connecting the first collar and the second collar and extending through the loop portion of the frame.

[0781] In some implementations, a driver can be used to transition the interface from a relaxed state, in which the loop portion is loosely coupled to the interface, to a tight state, in which the loop portion is sandwiched between the first and second collars.

[0782] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0783] In some implementations, a system (e.g., a system usable with or for use with a valve of a real or simulated heart of a subject (e.g., a live subject or a simulation), e.g., the valve has a first leaflet and an opposing leaflet, and the heart has a heart chamber located upstream from the valve) can include an anchor, an implant, and / or a delivery tool.

[0784] In some implementations, the anchor defines an anchor axis.

[0785] In some implementations, the implant can include wings and / or interfaces located at the base of the wings.

[0786] In some implementations, the delivery tool can include a catheter that is transluminally advanceable to the heart, a shaft disposed within the catheter, a coupling, and / or a driver.

[0787] In some implementations, the coupling can be attached to a distal end of the shaft, the shaft being configured to deploy the implant from the catheter via engagement of the coupling with the interface.

[0788] In some implementations, the shaft is configured to position the implant through engagement of the coupling portion with the interface in a predetermined position such that (i) the wings extend over the first leaflet toward the opposing leaflet, and / or (ii) the wings deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0789] In some implementations, the driver is configured to drive anchors into the tissue of the heart, thereby securing the implant in place.

[0790] In some implementations, the delivery tool is configured to transition the system between (i) a first state in which the coupling portion is engaged with the interface, (ii) a second state in which the coupling portion is engaged with the interface and the wings have a greater deflection potential relative to the anchor axis than in the first state, and / or (iii) a deployed state in which the coupling portion is disengaged from the interface.

[0791] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0792] In some implementations, the shaft has a proximal portion located proximal to the joint and a distal end of the shaft, and in some implementations, when the system is in the first state, the distal end of the shaft is fixed relative to the proximal portion of the shaft.

[0793] In some implementations, the delivery tool is configured to transition the system to the second state by releasing the distal end of the shaft from the proximal portion of the shaft.

[0794] In some implementations, the delivery tool is configured such that the distal end of the shaft is fixed relative to the proximal portion of the shaft when the delivery tool is in the deployed state.

[0795] In some implementations, the shaft further includes a tether and / or the delivery tool is configured to transition between the first state and the second state by adjusting the tension on the tether.

[0796] In some implementations, the distal end of the shaft is reversibly coupled to the proximal portion of the shaft such that increasing tension on the tether secures the distal end of the shaft to the proximal portion of the shaft and / or decreasing tension on the tether uncouples the distal end of the shaft from the proximal portion of the shaft.

[0797] In some implementations, the deflection potential of the wing along the anchor axis when the system is in the second state is approximately equal to the deflection potential of the wing along the anchor axis when the system is in the deployed state.

[0798] In some implementations, the coupling portion has an outer diameter that is no more than 10 percent larger than the outer diameter of the proximal portion of the shaft.

[0799] In some implementations, the coupling includes a spring, and in some implementations, the system can be transitionable between a first state and a second state by varying the tension on the spring.

[0800] In some implementations, the coupling comprises a tether, and in some implementations, the system can be transitionable between a first state and a second state by varying tension on the tether.

[0801] In some implementations, the system is transitionable between a first state and a second state when the driver is engaged with the anchor.

[0802] In some implementations, the system is transitionable between a first state and a second state when the interface is anchored to cardiac tissue.

[0803] In some implementations, the joint includes a hinge, and in some implementations, the system can be transitionable between the first state and the second state by adjusting the articulation of the hinge.

[0804] In some implementations, the system is configured such that transitioning the system from the second state to the first state increases the range of articulation of the hinge along the articulation axis.

[0805] In some implementations, the hinge is a first hinge and the articulation axis is a first articulation axis.

[0806] In some implementations, the joint can further include a second hinge configured to articulate along a second articulation axis that is non-parallel to the first articulation axis.

[0807] In some implementations, the joint is configured such that transitioning the system from the second state to the first state increases a second range of articulation of the hinge along a second axis of articulation.

[0808] In some implementations, the second joint movement axis is orthogonal to the first joint movement axis.

[0809] In some implementations, the system is transitionable between the first and second states by longitudinally moving the anchor through the joint.

[0810] In some implementations, the system is transitionable from the second state to the first state by anchoring the interface to cardiac tissue.

[0811] In some implementations, the interface includes a first collar, a second collar, and / or a neck portion, hi some implementations, the neck portion can connect the first collar to the second collar, and to the neck portion are coupled loop portions of the wings.

[0812] In some implementations, the system is configured such that when the system is in the first state, the loop portion is sandwiched between the first collar and the second collar, and in some implementations, when the system is in the second state, the loop portion can be loosely coupled to the interface.

[0813] In some implementations, the system is configured to transition from the second state to the first state by advancing the anchor distally through the interface.

[0814] In some implementations, the anchor includes an anchor head and a tissue engaging portion extending spaced apart from the anchor head.

[0815] In some implementations, the system is configured to transition from the second state to the first state by advancing the tissue engaging portion distally through the interface, causing the anchor head to abut and press distally against the interface.

[0816] In some implementations, the system is configured such that when the interface is in the second state, at least a portion of the anchor protrudes distally through the interface.

[0817] According to some implementations, a system (e.g., a system usable with or for use with real or simulated tissue of a subject (e.g., a living subject or a simulation)) may include an anchor and / or an implant.

[0818] In some implementations, the anchor can define an anchor head and a helical tissue-engaging element extending distally from the anchor head along the anchor axis.

[0819] In some implementations, the implant includes an interface configured to be anchored to a tissue site by helically advancing a tissue engaging element through the interface and into the tissue.

[0820] In some implementations, the interface can include a tubular anchor-receiving member defining a lumen and / or a locking body disposed within the lumen. In some implementations, the locking body can define a window dimensioned to facilitate helical advancement of the tissue-engaging element therethrough until the anchor head abuts the locking body.

[0821] In some implementations, the stop can define a wall configured to prevent non-helical advancement of the anchor distally through the interface.

[0822] In some implementations, at least one of the anchor and the implant is sterilized.

[0823] According to some implementations, a system and / or device (e.g., one usable with or intended for use with a real or simulated cardiovascular system of a subject (e.g., a live subject or a simulation)) may include anchors and / or drivers.

[0824] In some implementations, the anchor can include a helical tissue-engaging element defining an anchor axis of the anchor and having a distal point, the helical tissue-engaging element configured to (i) be threaded into tissue of the cardiovascular system by rotating the anchor about the anchor axis in a first rotational sense, and / or (ii) be unthreaded from tissue by rotating the anchor about the anchor axis in a second rotational sense opposite the first rotational sense.

[0825] In some implementations, the anchor can include an anchor head attached to the proximal end of the tissue engaging element and shaped to define (i) a smooth forward torque surface oriented in a second rotational direction and / or (ii) an anchor hook oriented in a first rotational direction about the anchor axis.

[0826] In some implementations, the driver can include a drive shaft and / or a drive head defining (i) a smooth driver threading surface facing in a first rotational direction, and / or (ii) a driver hook facing in a second rotational direction and shaped complementary to the anchor hook.

[0827] In some implementations, the driver is configured to apply torque to the anchor head in a first rotational direction by pressing the driver threading surface against the forward torque surface while pressing the anchor head distally, thereby threading the helical tissue engaging element into tissue.

[0828] In some implementations, the driver is configured to apply torque to the anchor head in a second rotational direction by engaging the driver hook with the anchor hook and pressing the driver hook against the anchor hook while pulling the anchor hook proximally, thereby unthreading the helical tissue engaging element from the tissue.

[0829] In some implementations, the anchor is sterilized.

[0830] In some implementations, the anchor head and tissue engaging element are configured to be cut from a unitary stock tube.

[0831] In some implementations, the anchor head and drive head are configured to be cut from a unitary stock tube.

[0832] According to some implementations, a system (eg, a system usable with or for use with a tissue of a subject) can include an anchor and / or a delivery tool.

[0833] In some implementations, the anchor can have a helical tissue-engaging element with a distal tip.

[0834] In some implementations, the anchor is an anchor head located at the proximal end of the tissue engaging element and can have the anchor head shaped to define (i) a forward torque surface and / or (ii) a reverse torque surface.

[0835] In some implementations, the delivery tool can include a catheter that is transluminally advanceable into the tissue and / or a driver that includes a drive shaft and a drive head located at a distal end of the drive shaft, the drive head being configured to apply a forward torque to the forward torque surface by rotating the drive head in a forward direction while the drive shaft is compressed, thereby threading the tissue engaging element into the tissue.

[0836] In some implementations, the drive head can be configured such that rotating the drive head in a counter-rotational direction (i) latches the drive head onto the anchor head in a manner that facilitates applying tension to the drive shaft while the drive head remains in contact with the anchor head, and / or (ii) applies a reverse torque to the counter torque surface while the drive head remains latched onto the anchor head and tension is applied to the drive shaft, thereby unthreading the tissue engaging element from the tissue.

[0837] In some implementations, the drive head can be configured such that applying tension to the drive shaft when the drive head is not latched onto the anchor head will pull the drive head away from the anchor head.

[0838] In some implementations, at least one of the anchor and the catheter is sterile.

[0839] In some implementations, the reverse torque surface of the anchor head can be configured to latch the drive head in a manner that maintains contact between the anchor head and the drive head when tension is applied to the drive shaft.

[0840] In some implementations, the forward torque surface of the anchor head defines a smooth surface that is closer to being perpendicular to the forward torque compared to being parallel to the forward torque.

[0841] In some implementations, the driver is configured to (i) thread the tissue engaging element into tissue, (ii) latch the drive head onto the anchor head, (iii) unscrew the tissue engaging element from the tissue, and (iv) disengage from the anchor head without changing the shape of the anchor head.

[0842] In some implementations, the driver is configured to (i) thread the tissue engaging element into tissue, (ii) latch the drive head onto the anchor head, (iii) unthread the tissue engaging element from the tissue, and (iv) disengage the drive head from the anchor head without changing the shape of the drive head.

[0843] According to some implementations, a method (e.g., a method usable with or for use with real or simulated tissue of a subject (e.g., a living subject or a simulation)) can include using a driver including a drive shaft and a drive head located at a distal end of the drive shaft to advance into tissue an anchor having (i) an anchor head defining (a) a forward torque surface and / or (b) a reverse torque surface, and / or (ii) a helical tissue-engaging element extending from the anchor head.

[0844] In some implementations, when the drive head is engaged with the anchor head, the driver can be used to apply a forward torque to the forward torque surface to drive the helical tissue engaging element into the cardiac tissue, thereby anchoring the anchor into the tissue.

[0845] In some implementations, the drive head can be disengaged from the anchor head. The disengaging step may include not changing the shape or configuration of the drive head or the anchor head.

[0846] In some implementations, the method further includes sterilizing the anchor.

[0847] In some implementations, the method further includes thereafter unthreading the tissue engaging element from the tissue by latching the drive head onto the anchor head and / or by applying a reverse torque to the reverse torque surface while pulling the anchor proximally using the drive head latched onto the anchor head.

[0848] In some implementations, the latching step includes rotating the driver in a counter-rotational direction to latch the drive head onto the anchor head.

[0849] In some implementations, the latching step includes latching the drive head onto the anchor head by sliding the drive head proximally relative to the anchor head.

[0850] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0851] According to some implementations, a method (e.g., a method usable with or for use with real or simulated tissue of a subject (e.g., a living subject or a simulation)) can include using a driver including a drive shaft and a drive head located at a distal end of the drive shaft to advance into tissue an anchor having (i) an anchor head defining (a) a forward torque surface and / or (b) a reverse torque surface, and / or (ii) a helical tissue-engaging element extending from the anchor head.

[0852] In some implementations, when the drive head is engaged with the anchor head, the driver can be used to apply a forward torque to the forward torque surface to drive the helical tissue engaging element into the cardiac tissue, thereby anchoring the anchor into the tissue.

[0853] In some implementations, the drive head can be disengaged from the anchor head, and in some implementations, the disengaging step can include not changing the shape or structure of the drive head or the anchor head.

[0854] Any of the above methods may be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0855] According to some implementations, a system (e.g., a system usable or intended for use with real or simulated tissue of a subject (e.g., a live subject or a simulation)) can include an implant, an elongate anchor, and / or a delivery tool. In some implementations, the implant can include an interface and an anchor-receiving member. In some implementations, the delivery tool can extend from a proximal portion to a distal portion.

[0856] In some implementations, the delivery tool can include a catheter containing the implant and adapted to be transluminally advanced into the tissue.

[0857] In some implementations, the delivery tool can include a shaft extending distally through the catheter, the shaft configured to (i) deploy the implant from the catheter and / or (ii) position the implant to position the interface and anchor receiving member against a tissue surface.

[0858] In some implementations, the delivery tool is configured to anchor the implant to the tissue by driving the anchor through the interface and the face of the tissue along a curved path within the tissue, whereby a distal portion of the anchor is guided out of the tissue and received by the anchor receiving member.

[0859] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0860] In some implementations, a distal portion of the shaft extends distally through the catheter, the distal portion of the shaft bifurcating into a first branch and a second branch, the branches positioned alongside each other within the catheter. In some implementations, the first branch can engage with the interface. In some implementations, the second branch can engage with the anchor receiving member.

[0861] In some implementations, the delivery tool further includes a flexible needle containing an anchor, the needle being deliverable through the shaft, through the interface and the tissue surface, and along a curved path within the tissue to the anchor receiving member.

[0862] In some implementations, the anchor comprises a shape memory material. In some implementations, the needle is configured to restrain the anchor in a compressed state. In some implementations, the needle can be retractable relative to the anchor, such that retracting the needle releases the anchor from the compressed state to the expanded state.

[0863] According to some implementations, a method (e.g., a method usable with or for use with a real or simulated heart of a subject (e.g., a live subject or a simulation)) can include transluminally advancing, within a catheter, into the heart (i) an implant including an interface and an anchor receiving member, and / or (ii) a shaft coupled to the interface.

[0864] In some implementations, the shaft can be used to deploy the implant from a distal opening in the catheter to position the interface and anchor receiving member against a tissue surface.

[0865] In some implementations, the implant can be anchored to the tissue by driving the anchor through the interface and the surface of the tissue along a curved path within the tissue, thereby causing a distal portion of the anchor to be guided out of the tissue and received by the anchor receiving member.

[0866] In some implementations, the system further includes sterilizing the implant, the shaft, and the catheter.

[0867] In some implementations, the anchor comprises a shape memory material. In some implementations, driving the anchor can include driving the anchor within the flexible needle through the interface and the face of the tissue and along a curved path within the tissue, causing a distal portion of the anchor to be guided out of the tissue and received by the anchor receiving member.

[0868] In some implementations, the needle can then be proximally retracted from the anchor, causing the anchor to transition from the compressed state to the expanded state.

[0869] In some implementations, the distal portion of the shaft bifurcates into a first branch coupled to the interface and a second branch coupled to the anchor receiving member.

[0870] In some implementations, the advancing step can include transluminally advancing the first branch and the second branch at the distal portion of the shaft side-by-side within the catheter.

[0871] In some implementations, the method further includes sterilizing the implant, the shaft, and the catheter.

[0872] According to some implementations, the system and / or device includes an implant for use with a valve of a subject's heart, the valve defining an annulus and having a first leaflet and an opposing leaflet, and the heart having a chamber located upstream from the valve.

[0873] In some implementations, the implant includes wings extending from a wing root portion to a wing tip portion.

[0874] In some implementations, the wings have a compressed state and / or an expanded state. In some implementations, the wings are biased to expand to the expanded state. In some implementations, the wings are mechanically expandable to transition to the expanded state.

[0875] In some implementations, the interface is connected to a root portion of the wing and configured to be anchored to tissue of the annulus such that the wing extends over the first leaflet and toward the opposing leaflet.

[0876] In some implementations, the implant is configured such that when the wings are in a compressed state, the implant has a hinge joint between the root portion and the interface, the hinge joint facilitating articulation of the root portion relative to the interface at the hinge joint, and in some such implementations, expansion of the wings to an expanded state constrains the hinge joint, thereby preventing articulation.

[0877] In some implementations, the implant is sterilized.

[0878] According to some implementations, the system includes an implant for use with a valve of a subject's heart, the valve defining an annulus and having a first leaflet and an opposing leaflet, and the heart having a chamber located upstream from the valve.

[0879] In some implementations, the implant includes wings extending from a wing root portion to a wing tip portion, and / or an interface. In some such implementations, the system includes an anchor and / or a delivery tool.

[0880] In some implementations, the delivery tool includes a catheter that is transluminally advanceable into the heart chamber and configured to receive the implant when the wings are in a compressed state, hi some implementations, the delivery tool includes a shaft engaged with the interface and configured to deliver the implant from the catheter into the heart chamber through engagement with the interface.

[0881] In some implementations, the delivery tool includes a driver configured to secure the implant within the expanded heart chamber by anchoring the interface to the heart tissue using anchors.

[0882] In some implementations, the implant is configured such that when the wings are in a compressed state, the root portion has a hinge joint with the interface, the hinge joint facilitating articulation of the root portion with respect to the interface at the hinge joint.

[0883] In some implementations, the wings are biased to expand to an expanded state upon deployment and / or expand to an expanded state to constrain the hinge joint and prevent articulation.

[0884] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0885] According to some implementations, the system includes an implant or device for use with a valve of a subject's heart, the valve defining an annulus and having a first leaflet and an opposing leaflet, and the heart having a chamber located upstream from the valve.

[0886] In some implementations, the implant / device includes wings extending from a wing root portion to a wing tip portion. In some implementations, the wings have a compressed state and / or an expanded state. In some implementations, the wings are biased to expand to the expanded state. In some implementations, the wings can be actuated to expand to the expanded state.

[0887] In some implementations, the implant / device includes an annular support connected to the root portion of the wing.

[0888] In some implementations, the implant / device is configured such that in the compressed state of the wings, the wings have hinge joints with the annular support, which facilitate articulation of the wings relative to the annular support at the hinge joints. In some such implementations, expansion of the wings toward the expanded state constrains the hinge joints, thereby preventing articulation.

[0889] In some implementations, the implant is sterilized.

[0890] In some implementations, the wing defines a contact surface and an opposing surface opposite the contact surface.

[0891] In some implementations, the system further includes an anchor and / or a delivery tool, hi some implementations, the delivery tool is a catheter and is transluminally advanceable into the heart chamber with the wings in a compressed state and the implant housed within the catheter.

[0892] In some implementations, the delivery tool includes a driver configured to deploy the implant from the catheter to expand the wings within the heart chamber, and the driver configured to position the implant in a predetermined position such that the wings extend over the first leaflet toward the opposing leaflet and / or the contact surface faces toward the first leaflet.

[0893] In some implementations, the implant / device defines an interface, and in some implementations, the driver is configured to secure the interface to the annulus by driving anchors through the interface and into tissue of the annulus when the implant is positioned in place and the wings are in an expanded state.

[0894] In some implementations, the annular support is shaped to rest against the atrial surface of the annulus when the implant is secured to the annulus and the wings are in an expanded state, thereby constraining the hinge joint and preventing deflection of the wing roots relative to the annulus.

[0895] In some implementations, the interface is a first interface and the annular support includes a first annular arm extending away from the hinge joint to the first interface, and / or the annular support further includes a second annular arm, and the second annular arm is coupled to the hinge joint and / or extends away from the hinge joint to the second interface.

[0896] In some implementations, the first annular arm is joined to the second annular arm at a hinge joint.

[0897] In some implementations, the implant / device is configured such that the hinge joint includes a sleeve defining an opening such that when the wings are in a compressed state, a thinned portion of the annular support is positioned within the opening.

[0898] In some implementations, the implant / device is configured such that the wings expand to an expanded state, causing the sleeve to slide from the thinned portion into the thickened portion of the annular support, the thickened portion having a cross-section sized to fit into the opening and restrain the hinge joint.

[0899] In some implementations, the thickened portion of the annular support has an oval cross section sized to fit into the opening and thereby restrain the hinge joint.

[0900] In some implementations, the sleeve is a first sleeve defining a first opening, and the hinge joint further includes a second sleeve defining a second opening.

[0901] In some implementations, the annular support includes a pair of annular arms, each having a thinned portion where the arms are joined and / or a thickened portion extending away from the thinned portion.

[0902] In some implementations, the wings expand toward the expanded state, causing each sleeve to slide from a thinned portion to a thickened portion of the corresponding annular arm, thereby constraining the hinge joint.

[0903] In some implementations, the annular support includes an expansion element having a compact state and / or an extended state in which the expansion element resists compression of the wings toward the compressed state.

[0904] In some implementations, the annular support is configured to apply an expansion force to the wings by extending the expansion element from a compact state to an extended state, the expansion force facilitating the expansion of the wings from the compressed state to the expanded state.

[0905] In some implementations, the expansion element is configured to resist transitioning from the extended state towards the compact state.

[0906] In some implementations, the expansion element includes a spring.

[0907] In some implementations, the expandable element includes multiple subunits, and the expandable element is configured such that the subunits interlock with one another as the expandable element extends to the extended state.

[0908] In some implementations, the expansion element includes multiple sub-units that are configured to lock together when the expansion element is in the extended state.

[0909] In some implementations, the expansion element is straighter in the extended state compared to the compact state.

[0910] In some implementations, the expansion element includes a hinge, and the expansion element is configured such that straightening the hinge straightens the expansion element.

[0911] In some implementations, the delivery tool further includes an expansion actuator configured to transluminally extend the expansion element from the compact state to the extended state.

[0912] According to some implementations, the system includes an implant / device for use with a valve of a subject's heart, the valve having a first leaflet and an opposing leaflet, the heart having an upstream chamber located upstream from the valve and a downstream chamber located downstream from the valve, hi some implementations, the implant / device is transitionable between a compressed state and an expanded state.

[0913] In some implementations, the implant / device includes wings extending from a wing root portion to a wing tip portion, hi some implementations, the wings define a contact surface and an opposing surface opposite the contact surface.

[0914] In some implementations, the implant / device and / or wing includes one or more arms (e.g., one arm, a pair of arms, three arms, etc.). In some implementations, each arm of the one or more arms is fixed relative to a distal portion of the wing and / or extends away from the wing and further extends away from the other arm of the pair to define a lateral portion of the arm disposed laterally from the wing.

[0915] In some implementations, the system includes a delivery tool including a catheter transluminally advanceable into the heart chamber, the catheter containing the implant when the implant is in a compressed state.

[0916] In some implementations, the system (e.g., a delivery tool, etc.) is configured to deploy the implant from the catheter and to position the implant in its expanded state and in a predetermined position with the wings extending from the root portion over the first leaflet and toward the opposing leaflet.

[0917] In some implementations, the system (e.g., a delivery tool, etc.) is configured to deploy the implant from the catheter and position the implant in its expanded state and at a predetermined location where the wings extend from the root portion over the first leaflet toward the opposing leaflet and the lateral portion of each arm abuts against and presses upstream against the downstream surface of the first leaflet at a corresponding lateral site located laterally from the wings, with the contact surface abutting against and pressing against the upstream surface of the first leaflet between the lateral sites.

[0918] In some implementations, at least one of the implant and the delivery tool is sterilized.

[0919] In some implementations, the catheter is configured to contain the implant when the implant is in a compressed state, and / or the implant includes a flexible frame that biases the implant to expand to an expanded state upon deployment from the catheter.

[0920] In some implementations, the delivery tool further includes a shaft reversibly engageable with the implant, the shaft configured to deploy the implant from the catheter, to position the implant in place, and / or to release the implant when it is in place.

[0921] In some implementations, the implant is configured to hold the first leaflet in place by sandwiching it between the wings and the lateral portions of each arm when the implant is in place and the shaft releases the implant.

[0922] In some implementations, when the implant is positioned in place, the lateral portions of each arm are configured to abut against and press upstream against the downstream surface of the first valve leaflet at a corresponding lateral site located laterally from the wing, with the contact surface of the wing root portion abutting against and pressing against the upstream surface of the first valve leaflet between the lateral sites, and / or the tip portions of the wings, in cooperation with the lateral portions of each arm and with tissue at the lateral sites, deflect upstream and downstream in a reciprocating manner in response to the cardiac cycle of the heart.

[0923] In some implementations, when the implant is positioned in place, the contact surfaces of the root portions of the wings abut and press against the upstream surface of the first leaflet between the lateral portions, thereby preventing the root portions from deflecting upstream.

[0924] In some implementations, when the implant is positioned in place, the contact surfaces of the root portions of the wings abut and press against the upstream surface of the first leaflet between the lateral portions, preventing the wings from deflecting upstream beyond the deflection limit, thereby defining the deflection limit of the wing during the cardiac cycle.

[0925] According to some implementations, a system for use with a subject's heart includes an anchor, an implant / device including an interface, and / or a delivery tool. In some implementations, the delivery tool includes a driver that engages with the anchor.

[0926] In some implementations, the delivery tool includes a shaft, the shaft including a coupling portion engageable with the interface and / or a locking member located at a distal portion of the shaft.

[0927] In some implementations, the locking member includes a first unit and a second unit and has a locked state in which the first unit is engaged with the second unit and / or an unlocked state in which the first unit is separated from the second unit and is translatable.

[0928] In some implementations, the delivery tool is configured to position the implant inside the heart via engagement of the coupling with the interface when the locking member is locked, and / or to secure the implant to the tissue by driving anchors into the tissue of the heart using a driver.

[0929] In some implementations, the delivery tool is configured to reversibly and repeatedly transition the locking member between locked and unlocked states and / or to disengage the coupling from the interface while the implant remains fixed relative to the tissue.

[0930] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0931] In some implementations, the coupling is configured to remain coupled to the interface as the locking member transitions between the locked and unlocked states.

[0932] In some implementations, the delivery tool is configured to disengage the coupling from the interface when the locking member is locked.

[0933] In some implementations, the delivery tool is configured to disengage the coupling from the interface when the locking member is unlocked.

[0934] In some implementations, the distal portion of the shaft on which the locking member is located is located more proximal than the bond.

[0935] In some implementations, a distal end portion of the shaft defines a joint.

[0936] In some implementations, transitioning the locking member from a locked state to an unlocked state while the coupling portion remains coupled to the interface and the implant remains fixed relative to the tissue facilitates deflection of the implant in response to the cardiac cycle of the heart.

[0937] In some implementations, the heart has a valve having a first leaflet and an opposing leaflet and / or a heart chamber located upstream from the valve, and the implant includes wings defining a contact surface and an opposing surface opposite the contact surface. In some implementations, the shaft can be configured to position the implant in a predetermined position where the wings extend over the first leaflet and toward the opposing leaflet via engagement of the coupling portion with the interface.

[0938] In some implementations, the system can be configured such that the lock can be transitioned from a locked state to an unlocked state to facilitate upstream and downstream deflection of the wings in response to the cardiac cycle while the implant remains in place and the coupling remains coupled to the interface and the implant remains fixed to the tissue.

[0939] In some implementations, the implant interface is located at the root portion of the wing, and the wing extends away from the interface to the tip portion of the wing, over the first leaflet, and toward the opposing leaflet.

[0940] In some implementations, the delivery tool is configured to secure the root portion of the wing to the tissue of the heart chamber by using a driver to drive the anchor through the interface and into the tissue of the heart chamber.

[0941] In some implementations, the delivery tool is configured to transition the locking member from a locked state to an unlocked state in a manner that facilitates deflection of the tip portions of the wings in an upstream and downstream direction in response to the cardiac cycle while the root portions of the wings remain fixed relative to the tissue of the heart chamber.

[0942] In some implementations, the system includes a pair of anchors. In some implementations, the interface is a first interface and the implant further includes a second interface. In some implementations, the coupling portion includes a first branch engageable with the first interface along a first branch axis and / or a second branch engageable with the second interface along a second branch axis that is non-parallel to the first branch axis.

[0943] In some implementations, the delivery tool includes a pair of drivers, each configured to drive one of the anchors along a respective axis, through a respective interface, and into tissue.

[0944] In some implementations, the distal end portion of the shaft defines a joint and / or the distal end portion bifurcates into a first branch and a second branch distal to the locking member.

[0945] In some implementations, when the locking member is in a locked state, the coupling is fixed relative to the proximal portion of the shaft, and in some implementations, when the locking member is in an unlocked state, the coupling is released from the proximal portion of the shaft.

[0946] In some implementations, the delivery tool includes a catheter configured to accommodate the implant and the shaft such that the first branch of the coupling and the second branch of the coupling are oriented along a proximal shaft axis of a proximal portion of the shaft.

[0947] In some implementations, the linkage includes a shape memory material that biases the first and second branches to flex away from each other upon release from the catheter.

[0948] In some implementations, the first branch and the second branch are configured to flex away from each other upon release from the catheter, where each of the first branch axis and the second branch axis is oblique with respect to the proximal shaft axis.

[0949] In some implementations, the delivery tool can include a tether and / or be configured to transition the locking member between a locked state and an unlocked state by adjusting tension on the tether within the heart.

[0950] In some implementations, the delivery tool is configured such that when the locking member is in an unlocked state, the first unit is separated from the second unit and / or the tether connects the first unit to the second unit.

[0951] According to some implementations, a method (e.g., a method usable with or for use with tissue of a subject (e.g., a live subject or a simulation), a real or simulated heart) can include transluminally advancing (i) an implant including an interface and / or (ii) a shaft coupled to the interface within a catheter into the heart. In some implementations, the shaft includes a locking member at a distal portion of the shaft, the locking member having a first unit and a second unit.

[0952] In some implementations, the method includes, when the locking member is locked to engage the first unit with the second unit, (a) deploying the implant from the catheter and / or securing the interface to the tissue by using a driver engaged with the anchor to drive the anchor through the interface and into the tissue.

[0953] In some such implementations, the method includes unlocking the locking member to separate the first unit from the second unit, thereby disengaging the coupling from the interface and / or withdrawing the shaft from the object.

[0954] In some implementations, the method further includes sterilizing the implant, the anchor, the shaft, and the catheter.

[0955] In some implementations, the disengaging step includes disengaging the coupling from the interface while the locking member remains unlocked.

[0956] In some implementations, the method further includes relocking the locking member to engage the first unit to the second unit before the disengaging step.

[0957] In some implementations, the disengaging step includes disengaging the coupling from the interface while the locking member remains locked.

[0958] In some implementations, the shaft includes a tether adjustably coupled to the locking member, and / or the unlocking step includes unlocking the locking member by reducing tension on the tether within the heart.

[0959] In some implementations, the method further includes, prior to the disengaging step, engaging the first unit to the second unit by relocking the locking member by increasing tension on the tether.

[0960] In some implementations, the method further includes assessing the functionality of the implant prior to the disengaging step and while the locking member remains unlocked.

[0961] In some implementations, the evaluating step includes evaluating the function of the implant while the driver remains engaged with the anchor. In some implementations, the method further includes disengaging the driver from the anchor prior to the evaluating step.

[0962] In some implementations, the evaluating step includes evaluating a deflection of the implant in response to a cardiac cycle of the heart.

[0963] In some implementations, the heart includes a valve having a first leaflet and an opposing leaflet, and / or a heart chamber located upstream from the valve, and / or the implant includes wings defining a contact surface and an opposing surface located opposite the contact surface.

[0964] In some implementations, the securing step includes securing the interface to tissue of the heart chamber by driving anchors through the interface and into the tissue of the heart chamber.

[0965] In some implementations, the unlocking step includes facilitating upstream and downstream deflection of the wings in response to the cardiac cycle. In some implementations, the evaluating step includes evaluating upstream and downstream deflection of the wings in response to the cardiac cycle.

[0966] In some implementations, the interface is disposed at a root portion of the wing, and the securing step includes securing the root portion of the wing to the tissue of the heart chamber by driving an anchor through the interface and into the tissue of the heart chamber, ie, such that the wing extends away from the interface to a tip portion of the wing, over the first leaflet, and toward the opposing leaflet.

[0967] In some implementations, the unlocking step includes unlocking the locking member while the root portions of the wings remain fixed relative to the tissue of the heart chamber, thereby facilitating deflection of the tip portions of the wings in an upstream and downstream direction in response to the cardiac cycle.

[0968] In some implementations, the evaluating step includes evaluating upstream and downstream deflections of the tip portions of the wings in response to the cardiac cycle.

[0969] In some implementations, the disengaging and withdrawing steps include disengaging the coupling from the interface and / or withdrawing the shaft from the object in response to the evaluating step.

[0970] In some implementations, the method further includes relocking the locking member to engage the first unit to the second unit before the disengaging step.

[0971] In some implementations, the method further includes, prior to the disengaging step, removing the anchor from the tissue using a driver in response to the evaluating step, repositioning the implant using the shaft, and / or repeating the securing and evaluating steps.

[0972] According to some implementations, the system includes an implant or device for use with a valve of a subject's heart, the valve having a first leaflet and an opposing leaflet, and the heart having a chamber located upstream from the valve. In some implementations, the implant / device includes an interface and a flexible wing coupled to the interface. In some implementations, the flexible wing has a contact surface and an opposing surface located opposite the contact surface.

[0973] In some implementations, the beam is connected to the wing along a portion of the wing (and / or is integral to the wing), and in some implementations, a line is coupled to the beam, and applying tension to the line causes the beam to become taut.

[0974] In some implementations, the system includes an anchor and / or a delivery tool, hi some implementations, the delivery tool includes a catheter that is transluminally advanceable into the heart chamber and configured to receive the implant.

[0975] In some implementations, the delivery tool includes a shaft engaged with the interface, the shaft configured to deploy the implant from the catheter via engagement with the interface to cause the wings to extend away from the interface within the heart chamber, and / or to position the implant at a predetermined location where the interface is located at a site within the heart and the wings extend over the first leaflet toward the opposing leaflet, with the contact surface facing the first leaflet.

[0976] In some implementations, a driver is adapted to engage the anchor, the driver being configured to anchor the interface to cardiac tissue by securing the implant in place using the anchor.

[0977] In some implementations, the delivery tool can be configured to apply tension to the line, thereby tightening the beam and thereby reshaping the wings within the heart.

[0978] In some implementations, at least one of the implant, anchor, and delivery tool is sterilized.

[0979] In some implementations, the line extends from a proximal portion of the line at a proximal portion of the delivery tool to a distal portion of the line that is coupled to the beam.

[0980] In some implementations, the proximal portion of the delivery tool can be configured to reshape the wings within the heart by applying tension to the proximal portion of the line, thereby tightening the beam.

[0981] In some implementations, the line extends from a proximal portion of the line, through the interface, to a distal portion of the line.

[0982] In some implementations, the wing defines a root portion where the interface is located and a tip portion along which the beam is connected to the wing.

[0983] In some implementations, the beam is connected to the wing along a portion of the periphery of the tip portion of the wing.

[0984] In some implementations, the line extends from a proximal portion of the line at the proximal portion of the delivery tool to a beam at the tip portion of the wing.

[0985] In some implementations, the proximal portion of the delivery tool is configured to reshape the tip portions of the wings within the heart by applying tension to the proximal portion of the line, thereby tightening the beam.

[0986] In some implementations, the delivery tool is configured to apply tension to the line to change the radius of curvature of the wings within the heart along orthogonal planes of the wings extending from the root portion to the tip portion.

[0987] In some implementations, the delivery tool is configured to apply tension to the line to increase the radius of curvature of the wings within the heart along orthogonal planes of the wings extending from the root portion to the tip portion.

[0988] In some implementations, the delivery tool is configured to apply tension to the line to reduce the radius of curvature of the wings within the heart along orthogonal planes of the wings extending from the root portion to the tip portion.

[0989] In some implementations, the beam is a rigid beam and / or is connected to the wing along a portion of the periphery of the tip portion of the wing such that the tip portion has greater stiffness than the root portion along an orthogonal plane of the wing extending from the root portion to the tip portion.

[0990] In some implementations, the distal portion of the line is generally parallel to the orthogonal plane of the wing extending from the root portion to the tip portion.

[0991] In some implementations, the delivery tool is configured to reshape the wings within the heart by applying tension to the line to reshape the beam.

[0992] In some implementations, the wings include a braided mesh, and / or the delivery tool is configured to reshape the wings within the heart by applying tension to the lines to reshape the beams, thereby reorienting the stitches of the braided mesh.

[0993] In some implementations, the line is a first line connected to a first portion of the beam and the implant further includes a second line connected to a second portion of the beam, and / or applying tension to the first line and the second line reshapes the wing by changing the distance between the first portion of the beam and the second portion of the beam.

[0994] In some implementations, the delivery tool is configured to vary the width of the wings within the heart by applying tension to the line to change the radius of curvature of the beam.

[0995] In some implementations, the delivery tool is configured to apply tension to the line to reduce the radius of curvature of the beam, thereby reducing the width of the wings within the heart.

[0996] According to some implementations, a method (e.g., a method usable with or for use with simulated tissue of a subject (e.g., a live subject or a simulation), a real or simulated heart) can include transluminally advancing, within a catheter, into the heart (i) an implant including an interface and an anchor receiving member, and / or (ii) a shaft coupled to the interface.

[0997] In some implementations, the method can include deploying the implant from a distal opening of the catheter using the shaft to position the interface and the anchor receiving member against a tissue surface.

[0998] In some implementations, the method can include anchoring the implant to the tissue by driving the anchor through the interface and a face of the tissue along a curved path within the tissue, thereby directing a distal portion of the anchor from the tissue and being received by the anchor receiving member.

[0999] Any of the methods described above, and any methods using the systems, assemblies, apparatus, devices, etc. herein, can be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, a body part can optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[1000] Any of the above systems, assemblies, devices, apparatus, components, etc. in this summary can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use on patients, and the methods herein can include (or can include additional methods that include or consist of) sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more systems, devices, apparatus, components, etc. herein.

[1001] The concepts herein will be more fully understood from the following detailed description of implementations taken in conjunction with the drawings. [Brief explanation of the drawings]

[1002] [Figure 1] FIG. 1 is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 2A] FIG. 2A is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 2B] FIG. 2B is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 3A]FIG. 3A is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 3B] FIG. 3B is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 3C] FIG. 3C is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 3D] FIG. 3D is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 3E] FIG. 3E is a schematic illustration showing a system including a delivery tool and an implant, including its aesthetic features, according to some implementations. [Figure 4] FIG. 4 is a schematic illustration showing implants defining lateral flaps, including their aesthetic features, according to some implementations. [Figure 5] FIG. 5 is a schematic illustration showing implants defining lateral flaps, including their aesthetic features, according to some implementations. [Figure 6] FIG. 6 is a schematic illustration showing an implant including a first wing and a second wing, including their aesthetic features, according to some implementations. [Figure 7] FIG. 7 is a schematic illustration showing an implant including a first wing and a second wing, including their aesthetic features, according to some implementations. [Figure 8A] FIG. 8A is a schematic illustration showing implants including expansion elements, including their aesthetic features, according to some implementations. [Figure 8B] FIG. 8B is a schematic illustration showing implants including expansion elements, including their aesthetic features, according to some implementations. [Figure 9A]FIG. 9A is a schematic illustration showing implants including expansion elements, including their aesthetic features, according to some implementations. [Figure 9B] FIG. 9B is a schematic illustration showing implants including expansion elements, including their aesthetic features, according to some implementations. [Figure 10A] FIG. 10A is a schematic illustration showing implants including expansion elements, including their aesthetic features, according to some implementations. [Figure 10B] FIG. 10B is a schematic illustration showing implants including expansion elements, including their aesthetic features, according to some implementations. [Figure 11] FIG. 11 is a schematic illustration showing the distal portion of a delivery tool, including its aesthetic features, according to some implementations. [Figure 12] FIG. 12 is a schematic illustration showing the distal portion of a delivery tool, including its aesthetic features, according to some implementations. [Figure 13A] FIG. 13A is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 13B] FIG. 13B is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 13C] FIG. 13C is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 13D] FIG. 13D is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 13E]FIG. 13E is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 13F] FIG. 13F is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 13G] FIG. 13G is a schematic illustration showing the use of a distal portion of a delivery tool to implant the ratcheting interface of an implant against tissue, including its aesthetic features, according to some implementations. [Figure 14] FIG. 14 is a schematic illustration showing the frames of implants, including their aesthetic features, according to some implementations. [Figure 15] FIG. 15 is a schematic illustration showing the frames of implants, including their aesthetic features, according to some implementations. [Figure 16] FIG. 16 is a schematic illustration showing the frames of implants, including their aesthetic features, according to some implementations. [Figure 17] FIG. 17 is a schematic illustration showing the frames of implants, including their aesthetic features, according to some implementations. [Figure 18] FIG. 18 is a schematic illustration showing the frames of implants, including their aesthetic features, according to some implementations. [Figure 19] FIG. 19 shows a schematic illustration of an implant including wings containing mesh, including its aesthetic features, according to some implementations. [Figure 20] FIG. 20 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 21] FIG. 21 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 22]FIG. 22 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 23] FIG. 23 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 24] FIG. 24 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 25] FIG. 25 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 26] FIG. 26 is a schematic illustration showing implants including bending elements, including their aesthetic features, according to some implementations. [Figure 27] FIG. 27 is a schematic illustration showing an implant including a tip portion and a root portion that can articulate relative to one another, including their aesthetic features, according to some implementations. [Figure 28] FIG. 28 is a schematic illustration showing an implant including a tip portion and a root portion that can articulate relative to one another, including their aesthetic features, according to some implementations. [Figure 29] FIG. 29 is a schematic illustration showing an implant including a tip portion and a root portion that can articulate relative to one another, including their aesthetic features, according to some implementations. [Figure 30] FIG. 30 is a schematic illustration showing an implant including a tip portion and a root portion that can articulate relative to one another, including their aesthetic features, according to some implementations. [Figure 31] FIG. 31 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 32] FIG. 32 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 33]FIG. 33 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 34] FIG. 34 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 35] FIG. 35 is a schematic illustration showing implants including restrictors, including their aesthetic features, according to some implementations. [Figure 36] FIG. 36 is a schematic illustration showing implants including restrictors, including their aesthetic features, according to some implementations. [Figure 37] FIG. 37 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 38] FIG. 38 is a schematic illustration showing implants including restrictors, including their aesthetic features, according to some implementations. [Figure 39] FIG. 39 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 40] FIG. 40 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 41] FIG. 41 is a schematic illustration showing implants including restrictors, including their aesthetic features, according to some implementations. [Figure 42] FIG. 42 is a schematic illustration showing restrictor-containing implants, including their aesthetic features, according to some implementations. [Figure 43] FIG. 43 is a schematic illustration showing implants including restrictors, including their aesthetic features, according to some implementations. [Figure 44] FIG. 44 is a schematic illustration showing implants including restrictors, including their aesthetic features, according to some implementations. [Figure 45]FIG. 45 shows a schematic illustration of an implant including wings that define the deflection limits of the wings, including their aesthetic features, according to some implementations. [Figure 46A] FIG. 46A is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 46B] FIG. 46B is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 47] FIG. 47 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 48] FIG. 48 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 49A] FIG. 49A is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 49B] FIG. 49B is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 50] FIG. 50 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 51] FIG. 51 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 52] FIG. 52 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 53] FIG. 53 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 54A] FIG. 54A is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 54B] FIG. 54B is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 55A] FIG. 55A is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 55B] FIG. 55B is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 56] FIG. 56 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 57] FIG. 57 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 58] FIG. 58 is a schematic illustration showing implants including annular arms, including their aesthetic features, according to some implementations. [Figure 59A] FIG. 59A is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 59B] FIG. 59B is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 59C] FIG. 59C is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 60A] FIG. 60A is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 60B] FIG. 60B is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 61A]FIG. 61A is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 61B] FIG. 61B is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 62A] FIG. 62A is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 62B] FIG. 62B is a schematic illustration showing implants with adjustable restrictors, including their aesthetic features, according to some implementations. [Figure 63A] FIG. 63A is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 63B] FIG. 63B is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 64A] FIG. 64A is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 64B] FIG. 64B is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 65] FIG. 65 is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 66A] FIG. 66A is a schematic illustration showing implants, each including legs, including their aesthetic features, according to some implementations. [Figure 66B] FIG. 66B is a schematic illustration showing implants, each including legs, including their aesthetic features, according to some implementations. [Figure 67A] FIG. 67A is a schematic illustration showing implants, each including legs, including their aesthetic features, according to some implementations. [Figure 67B] FIG. 67B is a schematic illustration showing implants each including legs, including their aesthetic features, according to some implementations. [Figure 68] FIG. 68 is a schematic illustration showing implants, each including legs, including their aesthetic features, according to some implementations. [Figure 69] FIG. 69 is a schematic illustration showing implants, each including legs, including their aesthetic features, according to some implementations. [Figure 70A] FIG. 70A is a schematic illustration showing implants each including legs, including their aesthetic features, according to some implementations. [Figure 70B] FIG. 70B is a schematic illustration showing implants each including legs, including their aesthetic features, according to some implementations. [Figure 71] FIG. 71 is a schematic illustration showing implants, each including legs, including their aesthetic features, according to some implementations. [Figure 72] FIG. 72 is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 73A] FIG. 73A is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 73B] FIG. 73B is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 73C] FIG. 73C is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 74A]FIG. 74A is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 74B] FIG. 74B is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 74C] FIG. 74C is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Fig. 74D] FIG. 74D is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 75A] FIG. 75A is a schematic illustration showing implants including restrictors that are adjustable by varying the tension of the tether, including their aesthetic features, according to some implementations. [Figure 75B] FIG. 75B is a schematic illustration showing implants including restrictors that are adjustable by varying the tension in the tether, including their aesthetic features, according to some implementations. [Figure 75C] FIG. 75C is a schematic illustration showing implants including restrictors that are adjustable by varying the tension in the tether, including their aesthetic features, according to some implementations. [Figure 75D] FIG. 75D is a schematic illustration showing implants including restrictors that are adjustable by varying the tension in the tether, including their aesthetic features, according to some implementations. [Figure 76A] FIG. 76A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 76B] FIG. 76B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 77A]FIG. 77A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 77B] FIG. 77B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 78A] FIG. 78A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 78B] FIG. 78B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 79A] FIG. 79A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 79B] FIG. 79B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 79C] FIG. 79C is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 80A] FIG. 80A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 80B] FIG. 80B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 80C] FIG. 80C is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 81A] FIG. 81A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 81B] FIG. 81B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 81C]FIG. 81C is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 81D] FIG. 81D is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 82A] FIG. 82A is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 82B] FIG. 82B is a schematic illustration showing adjustable implants, including their aesthetic features, according to some implementations. [Figure 83A] FIG. 83A is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 83B] FIG. 83B is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 84A] FIG. 84A is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 84B] FIG. 84B is a schematic illustration showing implants including tethers, including their aesthetic features, according to some implementations. [Figure 85A] FIG. 85A is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 85B] FIG. 85B is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 85C] FIG. 85C is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 85D] FIG. 85D is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 85E]FIG. 85E is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 86A] FIG. 86A is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 86B] FIG. 86B is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 86C] FIG. 86C is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 87A] FIG. 87A is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 87B] FIG. 87B is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 87C] FIG. 87C is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 87D] FIG. 87D is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 88A] FIG. 88A is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 88B] FIG. 88B is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 88C] FIG. 88C is a schematic illustration showing adjustable shafts, including their aesthetic features, according to some implementations. [Figure 89A] FIG. 89A is a schematic illustration showing implants and anchors, including their aesthetic features, according to some implementations. [Figure 89B] FIG. 89B is a schematic illustration showing implants and anchors, including their aesthetic features, according to some implementations. [Figure 89C] FIG. 89C is a schematic illustration showing implants and anchors, including their aesthetic features, according to some implementations. [Figure 90A] FIG. 90A is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 90B] FIG. 90B is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 90C] FIG. 90C is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 91A] FIG. 91A is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 91B] FIG. 91B is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 91C] FIG. 91C is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 91D] FIG. 91D is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 92A] FIG. 92A is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 92B] FIG. 92B is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 93A] FIG. 93A is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 93B] FIG. 93B is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 93C] FIG. 93C is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 93D] FIG. 93D is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 93E] FIG. 93E is a schematic illustration showing the use of a delivery tool to deploy implants, including their aesthetic features, according to some implementations. [Figure 94A] FIG. 94A is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 94B] FIG. 94B is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 94C] FIG. 94C is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 94D] FIG. 94D is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 94E] FIG. 94E is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 95] FIG. 95 is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 96A]FIG. 96A is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 96B] FIG. 96B is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 96C] FIG. 96C is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 96D] FIG. 96D is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 96E] FIG. 96E is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 97A] FIG. 97A is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 97B] FIG. 97B is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 97C] FIG. 97C is a schematic illustration showing the use of anchors for use with a driver, including their aesthetic features, according to some implementations. [Figure 98] FIG. 98 shows a schematic illustration of a system for driving anchors, including its aesthetic features, according to some implementations. [Figure 99] FIG. 99 is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 100] FIG. 100 is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 101]FIG. 101 is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 102] FIG. 102 is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 103A] FIG. 103A is a schematic illustration showing the implantation of an implant, including its aesthetic features, according to some implementations. [Figure 103B] FIG. 103B is a schematic illustration showing the implantation of an implant, including its aesthetic features, according to some implementations. [Figure 103C] FIG. 103C is a schematic illustration showing the implantation of an implant, including its aesthetic features, according to some implementations. [Figure 104A] FIG. 104A is a schematic illustration showing an implant, including its aesthetic features, according to some implementations. [Figure 104B] FIG. 104B is a schematic illustration showing an implant, including its aesthetic features, according to some implementations. [Figure 105A] FIG. 105A is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 105B] FIG. 105B is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 105C] FIG. 105C is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 105D] FIG. 105D is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 105E] FIG. 105E is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 106A] FIG. 106A is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 106B] FIG. 106B is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 106C] FIG. 106C is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 106D] FIG. 106D is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 106E] FIG. 106E is a schematic illustration showing a distal portion of a system for delivering an implant to a heart, including its aesthetic features, according to some implementations. [Figure 107] FIG. 107 is a schematic illustration showing the use of an adjustable implant, including its aesthetic features, according to some implementations. [Figure 108A] FIG. 108A is a schematic illustration showing the use of an adjustable implant, including its aesthetic features, according to some implementations. [Figure 108B] FIG. 108B is a schematic illustration showing the use of an adjustable implant, including its aesthetic features, according to some implementations. [Figure 109A] FIG. 109A is a schematic illustration showing the use of an adjustable implant, including its aesthetic features, according to some implementations. [Figure 109B] FIG. 109B is a schematic illustration showing the use of an adjustable implant, including its aesthetic features, according to some implementations. [Figure 110A] FIG. 110A is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 110B] FIG. 110B is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 110C] FIG. 110C is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 111A] FIG. 111A is a schematic illustration showing implants, including their aesthetic features, according to some implementations. [Figure 111B] FIG. 111B is a schematic illustration showing implants, including their aesthetic features, according to some implementations. DETAILED DESCRIPTION OF THE INVENTION

[1003] The described systems, apparatus, devices, methods, etc. should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and subcombinations with each other. The disclosed systems, apparatus, devices, methods, etc. are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed systems, apparatus, devices, methods, etc. require the presence of one or more particular advantages or the existence of a problem to be solved.

[1004] 1, 2A-2B, and 3A-3E, which are schematic illustrations showing a system 100 including a delivery tool 150 and an implant 200, according to some implementations. As described below, the delivery tool 150 can be used to deliver the implant 200 to the heart (e.g., its native valve 10) of a subject (e.g., a living subject, a simulation, etc.).

[1005] As shown, the delivery tool 150 can include a controller 120 for operating and / or steering the tool transluminally, such as from outside the subject. Thus, the controller 120 can be located at a proximal (e.g., extracorporeal) portion 143 of the tool, with the delivery catheter 140 extending from the proximal portion to the distal portion 142 of the tool. In some implementations, the catheter 140 contains a shaft 160 that extends from the proximal portion 143 to the distal portion 142 within the catheter.

[1006] In some implementations, catheter 140 is itself steerable (e.g., it may include one or more pull wires that may be pulled by controller 120 to bend a distal portion of the catheter). In some implementations, catheter 140 is configured to be passively steered, for example, by being advanced within and / or through an outer catheter (not shown).

[1007] In some implementations, as shown in the inset of FIG. 1 , the shaft 160 bifurcates at a distal portion of the shaft into two branches 161 that are juxtaposed within the catheter 140 at the distal portion 142 of the tool 150. In some implementations, each branch 161 is thinner than the portion of the shaft 160 proximal to the bifurcation. In some implementations, as shown in more detail in the inset of FIG. 3B , the shaft 160 (e.g., proximal to the branches 161) is thinner than the combined width of the branches 161. This configuration can advantageously allow the shaft 160 to be advanced into the heart through the catheter 140, which is thinner than the distal portion of the tool along most of its length (e.g., from the controller 120 to the distal portion 142 of the delivery tool 150).

[1008] As shown, each branch 161 of shaft 160 can be engaged with implant 200. In some implementations, as shown in more detail in FIG. 3B , each branch 161 is engaged at its distal end portion 162 with a corresponding interface or anchor receiving member 250 of implant 200. In some implementations, as shown, each distal end portion 162 defines a window 166 through which a ring 252 defined by the corresponding interface 250 protrudes.

[1009] In some implementations, one or more ripcords 180 extend from the proximal portion 143 (e.g., from the controller 120) to the distal portion 142, where the one or more ripcords 180 maintain engagement between the shaft 160 (e.g., its branch 161) and the interface 250. In some implementations, as shown, the ripcords 180 can extend within the shaft 160 and out of an opening 146 defined by the shaft. For example, as shown, the ripcords 180 can extend distally from the opening 146 and through the rings 252, such that the distal portion 182 of each ripcord is positioned distal to its corresponding ring, reversibly securing the implant 200 to the shaft 160. The ripcords 180 can be retracted transluminally (e.g., outside the body using the controller 120) to release the implant 200 from the shaft 160, as described below with reference to FIG. 3D . In some implementations, a single common ripcord is provided, which bifurcates at the distal end to function as two ripcords.

[1010] Implant 200 includes flexible wings 220, shown in Figures 1 and 2A, compressed (e.g., in a compressed state) within catheter 140 for delivery to the heart. When shaft 160 slides distally within catheter 140 (Figure 2B), wings 220 emerge from distal end 141 of the catheter, allowing the wings to gradually expand to the expanded state shown in Figure 3A. As shown, wings 220 extend from a root portion 230, where wing interface 250 is located, to a tip portion 232 of the wing.

[1011] In some implementations, as shown, the wings 220 include a flexible frame 224 (eg, a wire frame, such as a hollow tubular wire frame) that provides mechanical support for the wings.

[1012] In some implementations, the frame 224 includes a shape memory material (eg, a shape memory wire) that biases the wings toward an expanded state, such as when exposed from the catheter 140.

[1013] In some implementations, the frame 224 can be configured to be mechanically expandable such that it can be actuated to transition to an expanded state.

[1014] In some implementations, as shown, wings 220 include flexible sheet 226. In some implementations, as shown, wings 220 can include sheet 226 and frame 224, with the sheet covering the frame. In some implementations, sheet 226 defines holes 240 therethrough, which facilitate blood flow through the sheet and, therefore, through the wings.

[1015] 3B shows the wing 220 in an expanded state and positioned using the shaft 160 within the atrium 6 of the heart. As shown, the interface 250 is positioned at the annulus 11 of the mitral valve 10 of the heart such that the wing 220 extends over the native leaflet (e.g., the posterior leaflet 12) toward the opposing opposite leaflet (e.g., the anterior leaflet 14). With the wing 220 so positioned, a first or contacting surface 222 of the wing faces (e.g., contacts) the posterior leaflet 12, and a second or opposing surface 223 faces the atrium 6.

[1016] 3B, the tool 150 includes a pair of drivers 170 extending from the proximal portion 143 through the shaft 160 to the distal portion 142. Each driver has a drive head 172 at its distal end that engages with a corresponding anchor 30 (e.g., with its anchor head 32). As shown, the drive head 172 and / or anchor 30 is positioned at (e.g., within) the corresponding branch 161. The system 100 can be provided in this configuration, e.g., the implant 200 is advanced by the tool 150 with the drivers 170 and / or anchors 30 in this position.

[1017] As shown in FIG. 3C , with each interface 250 positioned at the valve annulus 11, a driver 170 is used to advance (e.g., thread) each anchor 30 through the interface 250 so that a portion of each anchor (e.g., the helical tissue-engaging element 34) emerges from the distal end portion 162 of one of the shaft branches 161 and enters the annular tissue, thereby securing the implant 200 to the annular tissue. In some implementations, as shown, the helical tissue-engaging element 34 advances through the annular tissue until the anchor head 32 abuts against the interface 250, securing the interface, and therefore the implant 200, to the tissue. Thus, each interface 250 can be considered to function as an anchor receiving member. In some implementations, as shown, the interface 250 is tubular with a proximal end and a distal end. In some implementations, the anchor head 32 can press against the proximal end of the tubular interface. In some implementations, as shown, the interface 250 defines teeth 254, and compressive force applied by the anchor head 32 against the interface can advantageously cause the teeth to protrude into the tissue.

[1018] As shown in Figure 3D, after the interfaces 250 are anchored to the annular tissue, the ripcords 180 can be retracted (e.g., pulled using the controller 120), thereby releasing the distal end portions 162 of the shaft branches 161 from their respective interfaces 250. The distal portion 142 of the delivery tool 150 can then be retracted, thereby withdrawing the catheter 140 and shaft 160 from the subject, while the implant 200 remains fixed to the annular tissue (Figure 3E).

[1019] In some implementations, the drive head 172 remains inside the prong 161 as the tool 150 is withdrawn.

[1020] 4-5, which are schematic illustrations of implants 200a, 200b according to some implementations. Implants 200a, 200b may be considered to be variations of implant 200, and may be similar, mutatis mutandis, to implant 200 disclosed above, at least in its general purpose, i.e., to be anchored to cardiac tissue to restore the function of native valve leaflets, except that flexible sheets 226a, 226b of implants 200a, 200b define lateral flaps 261a, 261b, respectively.

[1021] In some implementations, the flexible sheets 226a, 226b of the implants 200a, 200b are shaped so that when the implant is positioned over the mitral valve 10 as shown in FIG. 3B, the lateral flaps 260a, 260b extend laterally, e.g., bilaterally, onto the posterior leaflet 12 toward their respective commissures of the valve. In some implementations, the wings 220a, 220b are more flexible in the lateral flaps 260a, 260b compared to the medial regions 264a, 264b where the frame is located. The greater flexibility of the lateral flaps 260a, 260b facilitates attachment of the lateral flaps within the commissures, and in some implementations, the lateral flaps can be curved to further facilitate attachment within the commissures.

[1022] 5, the side flaps 260b define lateral ends (e.g., angled ends) 263 between the root portion 261 and the tip portion 262 of each side flap. For example, as shown, the lateral ends 263 can be shaped to impart a manta ray-like shape to the sheet 226b.

[1023] 6-7, which are schematic illustrations of implants 200c and 200d according to some implementations. Implants 200c and 200d may be considered variations of implant 200, and may be similar, mutatis mutandis, to implant 200 disclosed above, at least in its general purpose, i.e., to anchor to cardiac tissue to restore the function of native valve leaflets, except that implants 200c and 200d each include a second wing (e.g., secondary wing) 251 in addition to a first wing, such as wing 220. Accordingly, the second wing of implant 200c is designated as 251c, and the second wing of implant 200d is designated as 251d.

[1024] 6 and 7 show root portions 230, 230c, 230d of corresponding wings 220, 251c, 251d secured to the annulus 11 via interface 250. Thus, for each implant, second wing 251 extends from the root portion on the second / opposite surface 223 of wing 220 to tip portions 232c, 232d of the second wing.

[1025] In some implementations, as shown in FIGS. 6-7 , wing 220 is more flexible than second wing 251, for example, causing wing 220 to deflect (e.g., pivot relative to interface 250) farther into the ventricle during diastole than second wing 251 (upper frame in FIGS. 6 and 7 ). In some implementations, wing 251 has holes therethrough to facilitate antegrade blood flow despite little or no wing deflection. In some implementations, wing 251 simply comprises a frame with no covering. Note that such a configuration may facilitate antegrade blood flow between wings 251, 220 during diastole.

[1026] During ventricular systole (lower frames in FIGS. 6-7), wing 220 deflects toward the opposing leaflet 14 (e.g., as described above with respect to other implants) and also deflects toward second wing 251, which facilitates (e.g., controls or regulates) this movement of wing 220. For example, second wing 251 may be sufficiently stiff (e.g., stiffer than wing 220) to prevent wing 220 from deflecting (e.g., protruding) into the atrium and / or to support the protruding portion of native valve leaflet 12 during ventricular systole.

[1027] In some implementations in which the wings 220 define holes therethrough, the wings 220 deflect into a contacting position against the second wing 251 during systole, thereby blocking blood flow through the holes. That is, during systole, the wings 220 coapt and / or seal against the leaflets 14 and the second wing 251. In some implementations, the wings 220 also define holes therethrough to facilitate antegrade blood flow during diastole. However, these holes through the wings 220 can be offset (e.g., non-overlapping) relative to the holes in the second wing 251 such that, upon coaptation, the two wings collectively block blood flow through the implant.

[1028] In some implementations, wings 220, 251 can have substantially the same length, width, and / or shape as one another. This is shown with respect to wing 251c of implant 200c. In some implementations, during systole, second wing 251 is sandwiched between wing 220 and opposing leaflet 14. In some implementations, second wing 251 can have a different shape than wing 220 and / or a different length and / or width than wing 220.

[1029] In the example shown by implant 200d, second wing 251d is shorter than wing 220 (e.g., tip portion 232d of second wing is closer to interface 250 than tip portion 232 of wing 220).

[1030] In some implementations, wing 251d can prevent deflection of wing 220 while allowing tip portion 232 of wing 220 to behave in its flexible manner and optimally coapt against leaflet 14. For example, as shown with implant 200d, during systole, wing 251 can be sandwiched not between wing 220 and opposing leaflet 14, but rather directly between leaflets 12, 14.

[1031] Based on the above-described effects of second wing 251, in some implementations, second wing 251 can be considered a restrictor. Moreover, wing 251 (and / or its features) and other restrictors (and / or their features) described elsewhere herein can be interchangeable.

[1032] In some implementations, wing 220 and second wings 251c, 251d are disposed within a flexible pouch (not shown) that allows wing 220 to deflect toward and away from second wing 251c, 251d. In some implementations, the pouches are more flexible than their respective wings, allowing the pouches to expand during diastole and contract during systole, for example.

[1033] In some implementations, the pouch defines holes (e.g., on both sides of the pouch; one side covering the first / contact surface 222 of wing 220 and the other side covering second wings 251c, 251d). In some implementations, the holes facilitate antegrade blood flow during diastole. In some implementations, deflection of wing 220 away from second wing 251 expands the pouch, drawing blood in from outside the pouch (e.g., expanding the pouch) during diastole, while deflection of wing 220 toward second wing 251 compresses the pouch (e.g., contracting the pouch), expelling blood from the pouch during systole.

[1034] In some implementations in which the pouch defines holes, the pouch helps to prevent retrograde blood flow during systole. In some implementations, opposing sides of the pouch move toward each other during ventricular systole in a manner that prevents blood flow through the holes. For example, the holes on one side of the pouch can be offset (e.g., non-overlapping) relative to the holes on the other side of the pouch.

[1035] In some implementations, implants 200c, 200d include a third wing (not shown) that is also coupled to interface 250 at a root portion of the third wing and extends over second wings 251c, 251d to a distal portion of the third wing. In some implementations, the third wing is shorter and / or less flexible than second wings 251c, 251d. For example, the third wing can be the stiffest of the three wings, and wing 220 can be the most flexible of the three wings.

[1036] In some implementations, second wings 251c, 251d are deflectable toward and away from the third wing similar to how wing 220 is deflectable toward and away from second wings 251c, 251d. In some implementations, second wings 251c, 251d deflect away from the third wing during ventricular diastole, e.g., when wing 220 deflects away from second wings 251c, 251d. In some implementations, wing 220 deflects into contact with second wings 251c, 251d during ventricular systole, e.g., when second wings 251c, 251d deflect into contact with the third wing.

[1037] 8A-8B, 9A-9B, and 10A-10B, which are schematic illustrations showing implants 200e, 200f, 200g according to several implementations. Implants 200e, 200f, 200g may be considered to be variations of implant 200 and may be similar, mutatis mutandis, to implant 200 disclosed above, at least in its general purpose, i.e., to be anchored to cardiac tissue to restore the function of native valve leaflets, except that implants 200e, 200f, 200g each include expansion elements 270e, 270f, 270g coupled to wings 220.

[1038] In some implementations, implants 200e, 200f, 200g are delivered into catheter 140 with wings 220 in a compressed state (FIGS. 1 and 2A) and with corresponding expansion elements (e.g., expansion elements 270e, 270f, or 270g) in a compact state. Wings 220 can include shape memory frames 224 that bias the wings toward the expanded state, and expansion elements 270e, 270f, 270g are coupled to the wings such that each expansion element 270e, 270f, 270g transitions from the compact state to the extended state as wings 220 transition from the compressed state to the expanded state.

[1039] In some implementations, even though the shape memory frame 224 biases the wings toward the expanded state, in some cases, the implant 200 may be subjected to obstructing forces (e.g., from surrounding anatomical structures) that may resist the shape memory expansion force of the frame 224 toward the expanded state and / or distort the shape of the wings even after they reach the expanded state. For example, such forces may obstruct movement of the interface 250 away from one another. In some implementations, the expansion elements 270e, 270f, 270g are configured to resist such obstructing forces, thereby facilitating the expansion of the wings 220e, 220f, 220g to their respective expanded states and / or subsequently maintaining the wings in the expanded state.

[1040] Figures 8A, 9A, and 10A each show wings 220 in an intermediate state between the compressed and expanded states. That is, although implants 200e, 200f, and 200g are shown deployed from within catheter 140, wings 220 are still not fully expanded. Figures 8B, 9B, and 10B each show wings 220 fully expanded, with corresponding expansion elements 270e, 270f, and 270g extending from their compact states to their extended states. Note that interfaces 250 are spaced farther apart in Figures 8B, 9B, and 10B compared to Figures 8A, 9A, and 10A.

[1041] In some implementations, the expansion elements 270e, 270f, 270g apply an expansion force to the wings 220 as the expansion elements extend toward their extended state. In some implementations, the expansion force pushes the interfaces 250 apart, e.g., the expansion elements can be coupled to the interfaces 250 as shown. Alternatively or additionally, the expansion elements 270e, 270f, 270g can push or pull portions of the frame 224 and / or the branches 161 of the shaft 160.

[1042] In some implementations, the expansion element is more straight in its extended state than in its compact state and is straightened from the compact state to the extended state. For example, the expansion element can include an articulating hinge (expansion element 270f, FIGS. 9A-9B) and / or collinearly aligned subunits (expansion element 270g, FIGS. 10A-10B) to straighten the expansion element from the compact state to the extended state.

[1043] In some implementations, the expansion elements can be locking expansion elements, for example, including subunits that lock together when expansion elements 270f, 270g are in the extended state shown in Figures 9B and 10B. In some implementations, the expansion elements can only provide such locking, but not expansion force.

[1044] In some implementations, the expansion elements are "passive" expansion elements that apply an expansion force to wings 220 without needing to be actuated. Expansion element 270e is an example of such a passive expansion element. In some implementations, as shown, expansion element 270e can include a spring (FIGS. 8A-8B) that relaxes (e.g., expands) toward its extended state, and the spring is deformed (e.g., compressed), for example, while remaining in its compact state.

[1045] In some implementations, the expansion element is an "active" expansion element that applies an expansion force to the wings 220 when the expansion element is actuated. Expansion element 270f is an example of such an active expansion element. In some implementations, delivery tool 150 includes an expansion actuator 184 (FIGS. 9A-9B) that is used to transluminally actuate the expansion element from a compact state to an extended state to facilitate expansion of wings 220 from a compressed state to an expanded state. In some implementations, the expansion actuator 184 is used by extending, thereby compressing the expansion element. In the particular configuration shown, the expansion actuator 184 extends from the shaft 160 between the shaft branches 161.

[1046] 10A-10B show an expansion actuator 186 that includes a wire that is pulled (e.g., pulled from outside the subject, such as via controller 120) in a manner that causes the subunits of expansion element 270g to fit together.

[1047] In some implemen...

Claims

1. 1. A system for use with a valve of a subject's heart, the valve having an annulus, a first leaflet, and an opposing leaflet, the heart having an atrium located upstream from the valve and a ventricle located downstream from the valve, the system including an implant, the implant comprising: A flexible wing, a flexible wing extending from a root portion of the wing to a tip portion of the wing; a limb coupled to the wing; the root portion of the wing is configured to be positioned against an atrial region on the valve annulus adjacent the root of the first leaflet in a manner to support the wing extending from the root portion of the wing over the first leaflet toward the opposing leaflet; The system is configured such that when the root portion of the wing is positioned against the site, the limb extends away from the wing in a manner that reduces upstream deflection of the wing relative to the site and contacts tissue of the heart adjacent the root of the opposing valve leaflet.

2. The system of claim 1 , wherein the implant is sterile.

3. 3. The system of claim 1, wherein the implant is configured such that when the root portions of the wings are positioned against the site and when the limbs extend away from the wings to contact tissue of the heart, the tip portions of the wings deflect relative to the root portions of the wings in the reciprocating upstream and downstream directions in response to a cardiac cycle of the heart.

4. 4. The system of claim 1, wherein the limbs are configured such that when the root portions of the wings are placed against the site, the limbs extend away from the root portions of the wings and contact tissue of the heart in a manner that reduces the upstream deflection of the wings relative to the site.

5. 5. The system of claim 1, wherein the limbs are configured such that when the root portions of the wings are placed against the site, the limbs extend away from the tip portions of the wings and contact tissue of the heart in a manner that reduces the upstream deflection of the wings relative to the site.

6. 6. The system of claim 1, wherein the limbs are configured such that when the root portions of the wings are positioned against the site, the limbs extend away from the wings and contact tissue of the annulus in a manner that reduces the upstream deflection of the wings relative to the site.

7. 7. The system of claim 6, wherein the limbs define arms shaped such that when the root portions of the wings are positioned against the site, the arms are positioned against the atrial surface of the annulus in a manner that mitigates the upstream deflection of the wings relative to the site.

8. 8. The system of claim 7, wherein the implant further comprises an interface at the root portion of the wing, the interface configured to be secured to the site on the annulus by driving an anchor into tissue at the site.

9. 8. The system of claim 7, wherein the arms include anchor receiving members configured to be secured against the atrial surface of the annulus when the root portions of the wings are positioned against the site by driving anchors through the anchor receiving members and into tissue at the atrial surface of the annulus.

10. 10. The system of claim 9, wherein the arms are shaped such that when the root portions of the wings are positioned against the site, the anchor receiving members are positioned adjacent to commissures of the valve.

11. 10. The system of claim 9, wherein the arms are shaped such that when the root portions of the wings are positioned against the site, the anchor receiving member is positioned adjacent to the root portion of the first leaflet.

12. 10. The system of claim 9, wherein the arms are shaped such that when the root portions of the wings are positioned against the site, the anchor receiving member is positioned adjacent to the root portions of the opposing leaflets.

13. 6. The system of claim 1, wherein the limbs define legs that are shaped such that when the root portions of the wings are positioned against the site, the legs contact tissue of the ventricle in a manner that reduces upstream deflection of the wings relative to the site.

14. 14. The system of claim 13, wherein the implant further includes an interface at the root portion of the wing, the interface configured to be secured to the site on the annulus by driving an anchor into tissue at the site.

15. 14. The system of claim 13, wherein the legs are shaped such that when the root portions of the wings are positioned against the site, the legs contact tissue below the valve in a manner that cushions the wings from deflecting upstream relative to the site.

16. 16. The system of claim 15, wherein the legs are shaped such that when the root portions of the wings are positioned against the site, the legs are positioned adjacent commissures of the valve.

17. 16. The system of claim 15, wherein the legs are shaped such that when the root portions of the wings are placed against the site, the legs are positioned within the subannular groove of the valve.

18. 14. The system of claim 13, wherein the implant further includes an atrial support coupled to the wings and configured such that when the root portions of the wings are positioned against the site, the atrial support presses against the atrial surface of the annulus in a manner that presses the legs against the tissue of the ventricle.

19. 20. The system of claim 18, wherein the atrial support is shaped to surround the atrial surface of the annulus.

20. 20. The system of claim 18, wherein the atrial support is defined by a pair of arms extending in opposite directions from the root portion around the atrial surface of the annulus.

21. the ventricle is the left ventricle; the valve is a mitral valve; the first leaflet is the posterior leaflet of the mitral valve; the opposing leaflet is the anterior leaflet of the mitral valve; 14. The system of claim 13, wherein the legs are shaped such that when the root portions of the wings are positioned against the site, the legs contact tissue of the left ventricle posterior to the anterior leaflet.

22. 22. The system of claim 21, wherein the legs are shaped such that when the root portions of the wings are positioned against the site, the legs contact the fibrous trigone of the left ventricle.

23. the wings have a compressed state and are biased to expand to an expanded state; The limb includes an annular support coupled to the root portion of the wing, the annular support comprising: wherein in the compressed state of the wing, the wing has a hinged connection to the annular support at which articulation of the wing relative to the annular support is facilitated; and The system of claim 1 , wherein expansion of the wings toward the expanded state is configured to prevent the joint movement by constraining the hinge joint.

24. the implant further includes an interface at the root portion of the wing; the wing defines a contact surface and an opposing surface opposite the contact surface; The system comprises: Anchor and a delivery tool, said delivery tool comprising: a catheter, the catheter being transluminally advanceable into the atrium with the implant contained within the catheter when the wings are in the compressed state; and a driver, the driver comprising: deploying the implant from the catheter with the wings in the expanded state within the atrium; The implant the wings extend over the first leaflet toward the opposing leaflet; and to position the contact surface facing the first valve leaflet; and 24. The system of claim 23, wherein when the implant is positioned at the location and the wings are in the expanded state, the anchors are driven through the interface into tissue of the annulus, thereby securing the interface to the annulus.

25. 25. The system of claim 24, wherein the annular support is shaped to rest against the atrial surface of the annulus when the implant is secured to the annulus and the wings are in the expanded state, thereby constraining the hinge joint and preventing the root portions of the wings from deflecting relative to the annulus.

26. the interface is a first interface; the annular support includes a first annular arm extending away from the hinge joint to the first interface; The annular support further comprises a second annular arm, the second annular arm comprising: connected to the hinge joint; 26. The system of claim 25, extending away from the hinge joint to a second interface.

27. 27. The system of claim 26, wherein the first annular arm is joined to the second annular arm at the hinge joint.

28. The implant comprises: the hinge joint includes a sleeve defining an opening; a thinned portion of the annular support disposed within the opening when the wing is in the compressed state; and 24. The system of claim 23, wherein the wings are configured to expand toward the expanded state to slide the sleeve from the thinned portion into a thickened portion of the annular support, the thickened portion having a cross-section sized to fit into the opening and thereby restrain the hinge joint.

29. 30. The system of claim 28, wherein the thickened portion of the annular support has an oval cross-section sized to fit within the opening and thereby restrain the hinge joint.

30. the sleeve is a first sleeve defining a first opening; the hinge joint further includes a second sleeve defining a second opening; The annular support includes a pair of annular arms, each annular arm having: a thinned portion to which the annular arm is joined; a thickened portion extending away from the thinned portion, 29. The system of claim 28, wherein expansion of the wings toward the expanded state causes each sleeve to slide from the thinned portion to the thickened portion of the corresponding annular arm, thereby constraining the hinge joint.

31. 1. A device for use with a valve of a subject's heart, the valve having a first leaflet and an opposing leaflet, the heart having a chamber located upstream from the valve, the device including an implant, the implant comprising: A wing, extending from a root portion of the wing to a tip portion of the wing, the root portion being harder than the tip portion; a wing defining a contact surface and an opposing surface opposite the contact surface; an interface located at the root portion; The implant comprises: the interface is located upstream of the valve; and the wings extend over the first leaflet toward the opposing leaflet; and The device is configured to be implanted in a position where the contact surface faces the first leaflet.

32. 33. The device of claim 31 or 32, wherein the tip portions of the wings comprise flexible sheets.

33. An apparatus according to any one of claims 31 to 33, wherein the wing comprises a flexible frame that provides mechanical support to the root portion of the wing.

34. 34. The device of claim 33, wherein the frame defines a smaller open space at the root portion of the wings compared to the tip portion of the wings.

35. 34. The device of claim 33, wherein the frame members are thicker at the root portions of the wings compared to the tip portions of the wings.

36. 34. The device of claim 33, wherein members of the frame are spaced closer to one another at the root portions of the wings compared to the tip portions of the wings.

37. 34. The device of claim 33, wherein the frame comprises a wire frame, the wire frame comprising thicker wire at the root portion of the wings compared to the tip portion of the wings.

38. the frame at the root portion of the wing comprises a first material; the frame at the tip portions of the wings comprises a second material; 34. The device of claim 33, wherein the first material is harder than the second material.

39. 34. The device of claim 33, wherein the frame comprises a wire frame, the wire frame having wires more densely arranged at the root portion of the wing compared to the tip portion of the wing.

40. 40. The device of claim 39, wherein the wire frame comprises thicker wire at the root portion of the wings compared to the tip portion of the wings.

41. 34. The device of any one of claims 31 to 33, wherein the wings comprise a wire mesh.

42. 42. The device of claim 41, wherein the wing further comprises a flexible frame over which the wire mesh is disposed.

43. 42. The device of claim 41, wherein the wire mesh includes at least one of: (i) a tighter weave at the root portion than at the tip portion; and (ii) a thicker wire region at the root portion than at the tip portion.

44. 44. The device of any one of claims 31 to 43, wherein the wing defines a bending element, the bending element connecting the tip portion of the wing to the root portion of the wing.

45. 45. The device of claim 44, wherein the implant is configured such that when the implant is fixed in position, the bending element bends to facilitate deflection of the tip portion relative to the root portion in response to a cardiac cycle of the heart.

46. 1. A method for use with a simulated valve of a simulated heart, the simulated valve having a simulated annulus, a first simulated valve leaflet, and an opposing simulated valve leaflet, the simulated heart having a simulated heart chamber located upstream from the simulated valve, the method comprising: Inside the catheter A shaft and and advancing an implant into the simulated heart chamber, the implant comprising: an interface engaged to a distal end of the shaft; a flexible wing coupled to the interface; and deploying the implant from the catheter into the simulated heart chamber using the shaft; positioning the implant using the shaft so that the interface is located at a location on the simulated valve annulus and the wings extend over the first simulated valve leaflet toward the opposing simulated valve leaflet; anchoring the interface at the site; thereafter, pulling a ripcord to release the distal end of the shaft from the interface; and then withdrawing the catheter and the shaft from the simulated subject.

47. 1. A method for use with a simulation valve of a simulated heart, the simulation valve having a first simulation valve leaflet and an opposing simulation valve leaflet, the simulation heart having a first simulation chamber located upstream from the simulation valve and a second simulation chamber located downstream from the simulation valve, the method comprising: Inside the catheter A shaft and and advancing an implant into the first simulated heart chamber, the implant comprising: an interface engaged to a distal end of the shaft; a flexible wing coupled to the interface; and Using the shaft, deploying the implant from the catheter into the first simulated heart chamber; The implant the interface is located at a site within the first simulated heart chamber; and the wings extend over the first simulation leaflet toward the opposing simulation leaflet; and anchoring the wings in a position where they deflect upstream and downstream in a reciprocating manner in response to cardiac cycles of the simulated heart; thereafter adjusting the deflection range of the wings within the simulated heart.

48. 48. The method of claim 47, further comprising sterilizing the implant, the shaft, and the catheter.

49. the site is located at a simulated annulus of the simulated valve; 49. The method of claim 47 or 48, wherein anchoring the implant in position comprises anchoring the interface to the simulated annulus of the simulated valve.

50. the interface is coupled to a root portion of the wing; 50. The method of claim 49, wherein anchoring the interface to the simulated annulus comprises anchoring the interface to the simulated annulus with the root portion positioned at the simulated annulus and with the wings extending from the root portion over the first simulation leaflet and toward the opposing simulation leaflet.

51. the implant further includes a limiter that prevents the wing from deflecting in the upstream direction beyond the deflection limit, thereby defining the deflection limit of the wing during the cardiac cycle of the simulated heart; 51. The method of any one of claims 47 to 50, wherein adjusting the deflection range of the wing comprises adjusting the deflection limit of the wing by adjusting the limiter within the simulated heart.

52. Anchoring the implant at the location includes driving an anchor into tissue at the site; 52. The method of claim 51, wherein adjusting the restrictor comprises adjusting the restrictor by applying a torque to the anchor.

53. the restrictor includes a tether coupled to the wing; 52. The method of claim 51, wherein adjusting the deflection range of the wings comprises adjusting the deflection limits of the wings by adjusting tension on the tethers within the simulated heart.

54. 54. The method of claim 53, further comprising anchoring the tether to tissue of the second simulated heart chamber before adjusting the tension.

55. a portion of the tether wound around a rotatable spool; 54. The method of claim 53, wherein adjusting the tension on the tether comprises adjusting the tension on the tether via the catheter by rotating the spool using an external controller.

56. 54. The method of claim 53, wherein adjusting the tension on the tether comprises sliding the tether relative to the wing.

57. a first portion of the tether coupled to the wing; 56. The method of claim 55, wherein adjusting the tension on the tether includes passing a second portion of the tether upstream through a root portion of the wing.

58. 58. The method of claim 57, wherein adjusting the tension on the tether comprises passing the second portion of the tether in the upstream direction through the interface.

59. Anchoring the implant at the location includes anchoring the interface to the tissue by driving an anchor into tissue at the site, the anchor having an anchor head and a tissue engaging element extending from the anchor head to define an anchor axis of the anchor; 52. The method of claim 51, wherein adjusting the restrictor comprises biasing the restrictor relative to the anchor shaft.

60. 60. The method of claim 59, wherein deflecting the restrictor comprises at least one of: (i) changing a curvature of the restrictor; and (ii) causing the restrictor to make greater contact with the wing.

61. 61. The method of claim 60, wherein deflecting the restrictor includes deflecting the restrictor such that a portion of the restrictor contacts the wing when the wing reaches the deflection limit.

62. Anchoring the implant at the location includes driving an anchor into tissue at the site; 52. The method of claim 51, wherein adjusting the limiter comprises adjusting the limiter by driving the anchor deeper into the tissue at the site.

63. the anchor having an anchor head and a tissue-engaging element extending from the anchor head and defining an anchor axis of the anchor; 63. The method of claim 62, wherein adjusting the restrictor comprises biasing the restrictor relative to the anchor shaft.

64. the restrictor defining a rear catch; 52. The method of claim 51, wherein adjusting the restrictor comprises pressing the rear catch against tissue of the first simulated heart chamber.

65. the rear catch portion defines a spring; 65. The method of claim 64, wherein pressing the rear catch against the tissue of the first simulated heart chamber comprises applying tension to the spring.

66. the rear catch is an inflatable rear catch; 65. The method of claim 64, wherein pressing the rear catch against the tissue of the first simulated heart chamber comprises expanding the rear catch to press the rear catch against the tissue.

67. the implant includes a tether coupled to the wing; 67. The method of any one of claims 47 to 66, wherein adjusting the range of deflection of the wing comprises adjusting tension on the tether to adjust the range of deflection of the wing.

68. the tether is coupled to a tip portion of the wing; 68. The method of claim 67, wherein adjusting the tension on the tether comprises adjusting the deflectability of the tip portion of the wing.

69. the tether is slidably coupled to the root portion of the wing; 68. The method of claim 67, wherein adjusting the tension on the tether comprises adjusting the deflectability of the root portion of the wing by sliding the tether through a sleeve at the root portion of the wing.

70. the tether is slidably coupled to the root portion of the wing; 68. The method of claim 67, further comprising anchoring the tether to tissue of the first simulated heart chamber.

71. the tether is coupled to the wing; 68. The method of claim 67, further comprising anchoring the tether to tissue of the second simulated heart chamber.

72. the tether defining a rail portion to which a proximal portion of the tether is slidably coupled; The step of anchoring comprises: anchoring a first portion of the rail portion to a trabecula at a first location of the second simulated heart chamber; and anchoring a second portion of the rail portion to the trabeculae at a second location of the second simulated heart chamber.

73. a first portion of the tether coupled to the wing; 68. The method of claim 67, wherein adjusting the tension on the tether includes passing a second portion of the tether upstream through a root portion of the wing.

74. 74. The method of claim 73, wherein adjusting the tension on the tether comprises passing the second portion of the tether in the upstream direction through the interface.

75. 68. The method of claim 67, wherein adjusting the range of deflection of the wing by adjusting tension on the tether comprises adjusting tension on the tether to pivot the wing relative to the interface.

76. Anchoring the implant at the location includes anchoring the interface to the site by driving an anchor into tissue at the site, the anchor comprising: Anchorhead and a tissue engaging element extending from the anchor head along an anchor axis, 76. The method of claim 75, wherein adjusting tension on the tether to pivot the wings relative to the interface comprises adjusting tension on the tether to pivot the wings relative to the anchor axis.

77. the interface is an adjustable interface; A method according to any one of claims 47 to 76, wherein adjusting the range of deflection of the wing comprises adjusting the range of deflection by adjusting the interface.

78. the adjustable interface defining a seat; anchoring the implant includes seating the seat against tissue at the location within the first simulated heart chamber; 78. The method of claim 77, wherein adjusting the interface comprises adjusting an angle between a root portion of the wing and the seat of the interface.

79. the anchoring step includes anchoring the implant in the position using an anchor; the anchor defining an anchor head and a tissue engaging element extending from the anchor head along an anchor axis; 79. The method of claim 78, wherein adjusting the interface comprises adjusting an angle between the root portion of the wing and the anchor axis.

80. the adjustable interface includes an adjustment mechanism; 79. The method of claim 78, wherein adjusting the angle between the root portion of the wing and the seat of the interface comprises adjusting the angle between the root portion of the wing and the seat of the interface by actuating the adjustment mechanism.

81. the adjustable interface includes a base to which the root portions of the wings are fixedly coupled; 81. The method of claim 80, wherein adjusting the angle between the root portion of the wing and the seat of the interface comprises adjusting the angle between the base and the seat of the interface by actuating the adjustment mechanism.

82. the adjustment mechanism includes a lead screw; 82. The method of claim 81, wherein driving the adjustment mechanism comprises rotating the lead screw.

83. the anchoring step includes anchoring the implant in the position using an anchor; the anchor defining an anchor head and a tissue engaging element extending from the anchor head along an anchor axis; 83. The method of claim 82, wherein threading the lead screw comprises threading the lead screw along a lead screw axis that is offset relative to the anchor axis.

84. 1. A system for use with a target tissue, comprising: an anchor defining an anchor head and a helical tissue engaging element extending distally from the anchor head along an anchor axis; an implant including an interface configured to be anchored to the tissue site by helically advancing the tissue engaging element through the interface and into the tissue; The interface is a tubular anchor receiving member defining a lumen; a stop disposed within the lumen, a window sized to facilitate helical advancement of the tissue engaging element therethrough until the anchor head abuts the stop; a wall configured to prevent non-helical advancement of the anchor distally through the interface.

85. 1. A system for use at a target tissue, comprising: an implant including an interface and an anchor receiving member; A long anchor and a delivery tool extending from a proximal portion to a distal portion, a catheter containing the implant and transluminally advanceable into the tissue; a shaft extending distally through the catheter, configured to deploy the implant from the catheter; a shaft configured to position the implant to place the interface and the anchor receiving member against the tissue surface; a delivery tool configured to anchor the implant to the tissue by driving the anchor through the interface and a face of the tissue along a curved path within the tissue, whereby a distal portion of the anchor is delivered from the tissue and received by the anchor receiving member.

86. a distal portion of the shaft extending distally through the catheter, the distal portion of the shaft bifurcating into a first branch and a second branch; The branches are arranged side by side within the catheter; the first branch engages the interface; 86. The system of claim 85, wherein the second branch is engaged with the anchor receiving member.

87. 87. The system of claim 85 or 86, wherein the delivery tool further includes a flexible needle containing the anchor, the needle being deliverable through the shaft, through the interface and the tissue face, and along the curved path within the tissue to the anchor receiving member.

88. the anchor comprises a shape memory material; The needle configured to restrain the anchor in a compressed state; 88. The system of claim 87, wherein the anchor is retractable such that retracting the needle releases the anchor from the compressed state to an expanded state.

Images