Systems and techniques for heart valve leaflet repair - Patents.com

Abstract

A system and method for use with a heart valve is disclosed. The implant (100) includes wings (120), a flexible frame (124), and a pair of anchor receivers (150). A pair of shafts (660) are advanced transluminally through a catheter (40) while each shaft engages a respective anchor receiver (150), deploying the implant from the catheter such that the wings extend away from the anchor receivers and toward the opposing leaflet of the valve and over a first leaflet of the valve, with the contact surface (122) of the wings facing the first leaflet. A pair of drivers (70) secure the implant using a pair of anchors (30) to secure each anchor receiver to tissue at a respective site of the heart. Other implementations are also described.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority from the following: U.S. Provisional Patent Application No. 63 / 291,291, to Chau et al., entitled “Systems and Techniques for Heart Valve Leaflet Repair,” filed December 17, 2021; and U.S. Provisional Patent Application No. 63 / 321,546, filed March 18, 2022, by Chau et al., entitled "Systems and Techniques for Heart Valve Leaflet Repair."

[0002] This application is related to International Patent Application PCT / US2021 / 039587 by Cau et al., published as International Publication No. WO 2022 / 006087, entitled "Systems and methods for heart valve leaflet repair," filed June 29, 2021.

[0003] Each of the above references is incorporated herein by reference for all purposes.

[0004] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves may be rendered less effective by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves may lead to severe cardiovascular damage or even death. Treatment of such damage may be performed by surgical repair or replacement of the valves during open-heart surgery, or by transcatheter vascular techniques to introduce and implant prosthetic devices in a much less invasive manner than open-heart surgery.

[0005] A healthy heart has a generally conical shape that tapers toward the apex and 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 native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve includes an annular portion of native valve tissue that surrounds the mitral valve opening, the annulus portion, and a pair of leaflets (called cusps) that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting free ends of the leaflets.

[0006] When operating properly, the anterior and posterior leaflets function together as a one-way valve that can only allow blood to flow from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricular muscle expands, oxygen-rich blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts, the increased blood pressure in the left ventricle urges the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is ejected out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing or flapping under pressure and folding back through the mitral valve annulus toward the left atrium, multiple fibrous chordae, called chordae tendineae, anchor the leaflets to papillary muscles in the left ventricle.

[0007] Valve regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Valve regurgitation is the most common form of valvular heart disease. Mitral valve regurgitation has different causes, including prolapse or flail of the leaflets, restricted leaflet movement (e.g., due to leaflet stiffness / leaflet calcification), and / or stretching of dysfunctional papillary muscles.

[0008] There is a continuing need for effective devices and methods for treating fluttering, prolapse, and restricted leaflet motion. Summary of the Invention

[0009] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described in relevant parts of this disclosure may be included in the examples summarized herein.

[0010] Examples herein are directed to systems, devices, apparatus, methods, etc. that may mitigate leaflet flutter, prolapse, abnormal leaflet motion, and / or other problems. For example, various examples of the systems, devices, etc. provide contact pressure to areas of flutter, prolapse, or restriction of the leaflets. Some implementations of the systems, devices, etc. herein are anchored within the nearby vasculature.

[0011] Some implementations of the systems, devices, etc. herein are fixed directly to the valve annulus and / or leaflets. Some implementations of the systems, devices, etc. are placed over the leaflets to be treated.

[0012] In some implementations, the system and / or device (which may be used with a heart, e.g., a valve of a live subject or a simulated heart) may include an implant. In some implementations, the implant is configured to be implanted in a chamber of the heart upstream of the valve, e.g., within the ventricle. In some implementations, the implant may include wings and an anchor receiver (e.g., one anchor receiver, two anchor receivers, multiple anchor receivers, etc.). In some implementations, the wings define a contact surface and an opposing surface opposing the contact surface.

[0013] In some implementations, the wings may include a flexible frame having elastic and / or shape memory properties (e.g., including Nitinol, stainless steel, and / or polymers) such that the wings may be compressed, folded, or rolled for delivery into a chamber of the heart within a shaft that may pass through a catheter, and may automatically expand (e.g., self-expand) once deployed within the chamber of the heart. The implant may be delivered into the heart and secured to the tissue to restore the function of the native valve leaflets.

[0014] In some implementations, the frame is encased in a flexible sheet (e.g., comprising a textile and / or a polymer). In some implementations, the frame is encased in a braided mesh (e.g., formed from metal or polymer wire). In some implementations, the wing includes a braided mesh that serves the function of the frame, e.g., the wing does not include a separate frame in addition to the braided mesh.

[0015] In some implementations, the anchor receiver can be coupled to the wing. In some implementations, the anchor receiver is disposed at an edge of the wing, e.g., at an end of the wing opposite the tip of the wing. For example, the anchor receiver can be disposed at the root of the implant.

[0016] In some implementations, the anchor receiver can be configured to be secured to the annulus of the valve in a manner such that, for example, the wings extend over a first leaflet of the valve toward the opposing leaflet (i.e., second leaflet) of the valve, and the wings extend away from the anchor receiver such that a contact surface faces the first leaflet. For example, a tip of the wing can extend away from the anchor receiver toward the opposing leaflet.

[0017] In some implementations, during ventricular contraction, the contact surface may guide the first leaflet toward the opposing leaflet so that the first leaflet coapts with the opposing leaflet (e.g., at least a majority of the contact surface is in contact with the first leaflet). In some implementations, the tip of the wing may participate in the coaptation between the two leaflets, e.g., may be sandwiched between the two leaflets. However, in some implementations, the tip of the wing may extend beyond the lip of the first leaflet (e.g., may be located in the ventricle downstream of the valve being treated).

[0018] In some implementations, fixation of the implant (e.g., of its anchor receiver) is performed using a delivery tool that is also used to deliver the implant and position the implant relative to the tissue to which it is to be fixed. Thus, in some implementations, a system is provided that includes an implant and a delivery tool therefor.

[0019] In some implementations, the delivery tool may include one or more shafts and one or more drivers configured to advance anchors through their respective shafts and into their respective anchor receivers, thereby driving tissue engaging elements of each anchor through their respective anchor receivers and into tissue, e.g., where the heads of the anchors are retained (e.g., shielded) by the anchor receivers.

[0020] In some implementations, the coupling between the implant and the delivery tool can be such that the distal opening of each shaft faces its respective anchor receiver. This coupling can be provided in the anchor receiver (e.g., a coupling between a shaft and its respective anchor receiver) or can be provided, for example, by a separate connector on the delivery tool that couples to a separate interface on the implant.

[0021] In some implementations, the implant includes legs or extensions that extend from the tips of the wings to 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 a chamber downstream of the valve being treated. The legs or extensions may be configured to bias the wings of the implant toward a particular position and / or orientation and / or to prevent the wings from prolapsing into the atrium upstream of the valve being treated.

[0022] In some implementations, the legs are configured to maintain contact between the wings and the leaflets as the leaflets oscillate through multiple cardiac cycles.

[0023] In some implementations, the implant may include an adjustment node and an adjustment element that may be defined by or coupled to a frame, among other components. In some implementations, the adjustment node may be (or may be at) an anchor receiver of the implant. The adjustment node may be connected to the adjustment element, which extends from the adjustment node to another portion of the implant. For example, a first end of the adjustment element may be connected to the adjustment node, while a second end of the adjustment element is connected or connectable to another portion of the implant.

[0024] In some implementations, other portions of the implant may be a section of the frame, an anchor receiver, a second / another adjustment node and / or anchor receiver, a flexible sheet, and / or a braided mesh.

[0025] The adjustment element can be configured to facilitate intracardiac change (e.g., intracardiac adjustment) of the distance between the adjustment node and another portion of the implant. For example, the adjustment element can apply a force to the frame, which can in turn cause a change in the distance between the adjustment node and another portion of the implant.

[0026] In some implementations, the frame may be configured to facilitate intracardial variation (e.g., intracardial adjustment) of the distance between the adjustment node and other portions of the implant by changing its shape and / or size in response to a force applied by the adjustment element. For example, the width of the frame and / or the width of the implant may be adjusted intracardially to a set distance between the adjustment node and other portions of the implant.

[0027] In some implementations, the width and / or shape of the wings may be determined by changing the shape and / or width of the implant and / or frame. For example, decreasing the width of the frame may in turn decrease the width of the wings. The change in width of the wings within the heart may allow the size and / or shape of the wings to better match the treated leaflets.

[0028] In some implementations, the adjustment element is a tension member, such as a tether. In some implementations, the adjustment element is a compression member, such as a rod.

[0029] In some implementations, the implant can include two anchor receivers, each coupled to a wing and configured to be secured to the annulus of the valve.

[0030] In some implementations, the anchor receiver can be secured to the tissue of the heart in a manner such that, for example, the wings can extend away from the anchor receiver and over the first leaflet toward the opposing leaflet, with the contact surface facing the first leaflet.

[0031] In some implementations, the flexibility of the wings (e.g., their frames) can allow the distance between the first anchor receiver and the second anchor receiver to be altered within the heart. Changing the distance between the first anchor receiver and the second anchor receiver can affect the size and / or shape (e.g., width and / or length) of the wings.

[0032] In some implementations, the distance between the two anchor receivers is adjustable using an adjustment element coupled to both of the anchor receivers and / or an adjustment element coupled to one or more other portions of the implant.

[0033] In some implementations, the distance between the two anchor receivers is adjustable using a component of a delivery tool used to deliver and implant the implant, e.g., a component of the delivery tool that is coupled to the anchor receiver, such as a shaft of the delivery tool through which an anchor may subsequently be introduced to secure the anchor receiver to tissue. For example, one or both of the shafts may be movable to adjust the distance of separation between the shafts, and thereby, the anchor receivers.

[0034] In some implementations, at least one lance (e.g., spike) can be used to improve stabilization of the implant to tissue. For example, the lance can prevent and / or reduce the likelihood of inadvertent movement of the implant (e.g., its anchor receiver) before, during, and / or after fixation. In some implementations where the implant includes two anchor receivers, the lance can prevent and / or reduce the likelihood of inadvertent changes in the separation distance and / or orientation between the two anchor receivers.

[0035] In some implementations, the lance is a component of the implant, for example, coupled to the anchor receiver and / or the wing or any portion thereof (such as the root of the wing). In some implementations, the lance is a component of the delivery tool.

[0036] In some implementations, the system and / or device (which may be used, for example, in a live subject or in a simulated cardiac tissue) may include an implant including wings having a root and a tip, and a delivery tool.

[0037] In some implementations, the implant may further include an anchor receiver at the wing root that may include a lance and that is configured to receive the anchor, among other components. In some implementations, the lance may be attached to the wing root and / or the anchor receiver and configured to stabilize the implant relative to tissue, e.g., the lance may prevent the implant from pivoting about a central axis of the anchor receiver and / or a central axis of the anchor, e.g., primarily if the implant includes a single anchor receiver, and / or may prevent the implant from moving along the tissue.

[0038] In some implementations, the delivery tool can include a shaft that can be configured to position the implant at a location where the root is at a site within the heart, for example, via engagement with the root and / or anchor receiver.

[0039] In some implementations, the shaft may also be configured to secure the root to tissue at the site, e.g., by driving the lance into tissue via engagement with the root and / or anchor receiver, and then reorienting the lance within the tissue (e.g., transitioning the lance from a deformed position and / or first angle toward a rest position and / or second angle). For example, the shaft may position the implant in a position where the lance engages the tissue such that at least a portion of the lance may be inserted into the tissue in a manner that stabilizes the implant relative to the tissue.

[0040] It is believed that stabilizing the implant, in general, and in particular the root of the alar (and / or anchor receiver disposed at the root) relative to tissue during implantation, e.g., prior to and / or during fixation, is advantageous. It is further believed that stabilization may advantageously prevent undesired movement of the implant after implantation, e.g., due to natural movement of the heart and / or blood flow.

[0041] In some implementations, the implant can include one or more lances, among other components. For example, the lance can be attached to the wing root, the anchor receiver, the frame, the wing, and / or any other component of the implant.

[0042] In some implementations, the lances can be attached to the implant such that each lance can be oriented in a different direction, for example, to increase the stability of the implant.

[0043] In some implementations, for example, where the implant includes multiple anchor receivers, the lance may be attached to each of the anchor receivers and / or to any other element of the implant, such as the root portion around each anchor receiver.

[0044] In some implementations, the implant can be articulated to the tissue of the heart rather than using an anchor driven through an anchor receiver of the implant. For example, the anchor receiver of the implant can be connected to the anchor by a rail. The implant can be slidably coupled to the rail.

[0045] In some implementations, the implant can include a wing and an anchor receiver coupled to the wing.

[0046] In some implementations, the anchors (e.g., the first anchor and the second anchor) can be configured to secure the rail to tissue of the heart and indirectly secure the anchor receiver to the tissue by coupling the anchor receiver to the rail. The anchors can be configured to be secured to tissue of the heart and can be similar to the anchors described elsewhere herein. For example, the anchors can be configured to be implantable at the first site and the second site, respectively.

[0047] In some implementations, the rail may extend from the first anchor to the second anchor, defining an axis of movement between the anchors. In some implementations, the rail may be threaded through the first anchor receiver and the second anchor receiver, thereby allowing movement, e.g., sliding, of the implant or any portion thereof, such as the wing, along the rail. Thus, the anchor receiver may be configured to allow movement of the wing along the rail and the axis of movement. For example, the first and second anchor receivers may be movable along the rail, and the wing may be movable along the axis of movement via movement of the anchor receiver.

[0048] In some implementations, the anchor receiver can be structured to have a receiving portion configured to receive the rail. For example, the rail can pass through the receiving portion.

[0049] In some implementations, each of the anchor receivers may further include a corresponding slider (e.g., a lacing eye or loop). Each slider may be configured to facilitate the anchor receiver being slidable along the rail, for example, by allowing the rail to pass between the slider and another portion of the implant (e.g., the root of the ala). For example, the slider may protrude slightly into the chamber upstream of the valve.

[0050] In some implementations, at least one stopper can be used to fix the implant (e.g., its wings) at a particular position along the movement axis, e.g., after a particular position identified as optimal. In some implementations, at least one stopper is used to limit, but not completely eliminate, movement of the implant along the movement axis. In some implementations, multiple stops can be used, e.g., at least one per anchor receiver.

[0051] The rails can be flexible, semi-flexible, or rigid. For example, the rails can be tethers, strings, wires, or rods. In some implementations, different portions of the rails can be formed from different materials. In some implementations, the ends of the rails can be flexible while the section in between can be rigid, or vice versa.

[0052] The implant can be implantable, for example, with first and second anchors such that the rail can be threaded through the anchor receiver in such a manner that the wings can extend away from the anchor receiver, for example, over the first leaflet toward the opposing leaflet, and the contact surface faces the first leaflet.

[0053] In some implementations, the system and / or device (which may be used in the heart, e.g., valves of a living subject or a simulated heart) includes, among other components, two or more shafts and / or drivers that may be used within the heart. The system may use two or more shafts and / or drivers simultaneously, which may be advanceable transluminally into the chambers of the heart while positioned alongside one another within a delivery tool.

[0054] In some implementations, the system may include, among other components, a delivery tool and an implant, such as, for example, any one of the implants and variations thereof, including two or more anchor receivers, as disclosed herein, mutatis mutandis. For example, the implant may include, among other components, a flexible frame and may include wings that may define a contact surface and an opposing surface opposing the contact surface.

[0055] In some implementations, two anchor receivers, e.g., a first anchor receiver and a second anchor receiver, can be coupled to the wings, and each of the anchor receivers can be configured to be secured to the annulus of the valve in a manner such that the wings can extend away from the anchor receiver and over the first leaflet toward the opposing leaflet, with the contact surface facing the first leaflet.

[0056] In some implementations, the anchor receiver can be secured to the heart tissue directly or indirectly, for example, by a first anchor and a second anchor configured to be coupled to the wing via a first and second anchor receiver, respectively, hi some implementations, the two anchors can be implanted at a site upstream of the valve and configured to support the implant therefrom.

[0057] In some implementations, the delivery tool can include, among other components, a catheter advanceable transluminally into a chamber of the heart that can facilitate two shafts and / or two drivers simultaneously. For example, a first shaft and a second shaft can be positioned alongside one another within the catheter.

[0058] In some implementations, each shaft can be configured to engage a corresponding anchor receiver and, through engagement with the corresponding anchor receiver, position the implant, for example, at a required location. For example, the shaft can first deploy the implant out of the catheter in the chamber such that the wings can extend away from the anchor receiver.

[0059] In some implementations, once the implant is deployed, e.g., with the wings expanded, the shaft can position the implant in a position where the first anchor receiver is at a first site of the heart and the second anchor receiver is at a second site of the heart. In some implementations, the implant can be implanted (e.g., via positioning of the anchor receivers) such that the wings extend over the first leaflet towards the opposing leaflet and the contact surface faces the first leaflet.

[0060] In some implementations, the drivers, e.g., a first driver and a second driver, can each be engaged with a corresponding anchor. In some implementations, after positioning the anchor receivers at their sites, the drivers can secure the implant in place by using the first anchor to secure the first anchor receiver to tissue of the heart at the first site and the second anchor to secure the second anchor receiver to tissue at the second site of the heart.

[0061] In some implementations, the anchors may be secured simultaneously or sequentially.

[0062] In some implementations, the flexibility of the fixation procedure made possible by the simultaneous introduction of two shafts into the heart chambers may allow the implant to be adjusted within the heart and fixed to the tissue according to in situ requirements such as the natural movement of the heart, blood pressure, etc., which may constantly change.

[0063] In some implementations, each of the shafts may be independently moved within a chamber of the heart, for example, a first shaft engaging a first anchor receiver may move the first anchor receiver within the chamber and / or position it at a first location, while a second shaft engaging a second anchor receiver may independently move the second anchor receiver within the chamber and / or position it at a second location.

[0064] In some implementations, movement and / or positioning of the second anchor receiver within the chamber can occur simultaneously with movement and / or positioning of the first anchor receiver. In some implementations, flexibility of the implant's frame facilitates this independence. For example, the distance between the first anchor receiver and the second anchor receiver can be alterable within the heart by movement of the first shaft relative to movement of the second shaft.

[0065] In some implementations, the distance between the first anchor receiver and the second anchor receiver may be determined by the orientation between the shafts and / or the distance between the end of the first shaft and the end of the second shaft. For example, the distance between the first anchor receiver and the second anchor receiver, and consequently the shape and / or size of the implant and / or wings, may be set by anchoring of the second anchor with a second driver at a second site of the heart relative to anchoring of the first anchor at the first site.

[0066] In some implementations, the system and / or device (e.g., which may be used in a living subject or a simulated heart) includes, among other components, an implant including an anchor and an anchor receiver (e.g., one anchor receiver, two anchor receivers, multiple anchor receivers, etc.), and a delivery tool including an engagement portion (e.g., a shaft including a shaft coupling mechanism) configured to engage with the receiver coupling of the anchor receiver of the implant.

[0067] In some implementations, the engagement portion can be configured to maintain engagement between the shaft coupling and the receiver coupling, thereby securing the shaft to the anchor receiver. Securing the anchor receiver to the shaft allows the shaft to manipulate and / or position the anchor receiver, which can aid in positioning the implant at a site within the chamber.

[0068] In some implementations, the delivery tool can include, among other components, a shaft having an engagement portion at its distal end such that the engagement portion can engage with the anchor receiver. For example, a shaft coupling of the shaft can be engaged with a receiver coupling of the anchor receiver.

[0069] In some implementations, the engagement portion and the anchor can be configured to maintain engagement between the shaft (e.g., its shaft coupling) and the anchor receiver (e.g., its receiver coupling) while the anchor is disposed in the engagement portion.

[0070] In some implementations, the delivery tool may include a driver configured to secure the implant to the cardiac tissue by engaging the anchor and using the anchor to secure the anchor receiver to the cardiac tissue.

[0071] In some implementations, the engagement portion can be biased toward disengagement from the anchor receiver, e.g., a portion of the engagement portion can be biased to move away from the anchor receiver.

[0072] In some implementations, an anchor disposed in the engagement portion may prevent the engagement portion from disengaging from the anchor receiver, for example, by holding components of the engagement portion together.

[0073] The anchor receiver may have a variety of different heights and / or shapes, as detailed herein. The shape and / or dimensions of the anchor receiver may be configured to allow the tissue engaging element of the anchor to pass therethrough.

[0074] In some implementations, regardless of its height and / or shape, the anchor receiver can define a receiver coupling. In some implementations, the receiver coupling can be on an outer surface of the anchor receiver, e.g., for a tubular anchor receiver, the receiver coupling can be on an outer surface of the tube. In some implementations, the receiver coupling can include a protrusion, such as a ridge or arm.

[0075] In some implementations, each shaft of the delivery tool defines a respective lumen. In some implementations, the lumens can have a central longitudinal axis, such that a midplane in which the central longitudinal axis lies is defined by the delivery tool at the distal end of the shaft. In some implementations, the midplane can be a plane of symmetry with respect to at least the distal end of the shaft.

[0076] In some implementations, the distal end of the shaft may define an engagement portion.

[0077] In some implementations, the engagement portion can include a jaw and a locker. For example, the engagement portion can be comprised of a first jaw and a second jaw opposing the first jaw, such that at least one of the jaws defining the shaft coupling is configured to engage a receiver coupling. For example, the shaft coupling can be a recess, slot, notch, receptacle, or similar opening configured to facilitate the receiver coupling, such as a ridge, or any type of protrusion configured to be secured within an opening in the shaft coupling.

[0078] In some implementations, the shaft coupling may include an opening configured to accommodate and thereby secure a protrusion of any type of receiver coupling therein.

[0079] In some implementations, the jaws can be biased to pivot away from each other and away from the mid-plane. For example, the jaws can be made of a shape memory material and / or the shaft coupling can include at least one spring configured to urge at least one of the jaws away from the mid-plane. In some implementations, one jaw can be stationary while the other jaw can be biased to pivot away from the stationary jaw and away from the mid-plane.

[0080] In some implementations, the rockers may be secured to one or both of the jaws. For example, a first rocker may be secured to a first jaw such that pivoting the first jaw away from the mid-plane allows at least a portion of the first rocker to move toward the mid-plane. Respectively, a second rocker may be secured to a second jaw such that pivoting the second jaw away from the mid-plane allows at least a portion of the second rocker to move toward the mid-plane.

[0081] In some implementations, the anchor can be dimensioned such that the anchor (e.g., a head of the anchor) can be positioned between the first jaw and the second jaw in a manner that maintains the engagement portion's engagement with the anchor receiver, e.g., by maintaining the engagement between the shaft coupling and the receiver coupling, while the engagement portion engages with the anchor receiver (e.g., via engagement between the shaft coupling and the receiver coupling). For example, the position of the anchor between the jaws can prevent the first rocker portion and the second rocker portion from moving toward the midplane.

[0082] In some implementations, the system and / or device may include a delivery tool having two (or more) shafts and an implant having two (or more) corresponding anchor receivers. In some implementations, the system may also include a connector (e.g., as a component of the delivery tool) and an interface (e.g., as a component of the implant).

[0083] In some implementations, the connection between the connector and the interface can, for example, maintain each of the anchor receivers aligned with the distal opening of a corresponding one of the shafts without the shaft engaging (at least not directly) with the anchor receivers, or in some cases even contacting the anchor receivers.

[0084] In some implementations, the system can include a delivery tool and an implant, where the implant includes two or more anchor receivers and an interface. For example, the implant can include a first anchor receiver and a second anchor receiver that can be coupled to the wing, and an interface that can be adjacent to the first and / or second anchor receiver.

[0085] In some implementations, the delivery tool can include a catheter, two shafts, two drivers, and a connector. In some implementations, the two shafts (e.g., a first shaft and a second shaft) can extend parallel to one another through a lumen of the catheter.

[0086] In some implementations, the first and second shafts each terminate in a distal opening configured to align with a corresponding anchor receiver that is held in alignment, for example, by a connection between the connector and the interface.

[0087] In some implementations, each of the two drivers, e.g., a first driver and a second driver, can be configured to advance a corresponding one of the anchors through a corresponding one of the shafts and secure a corresponding one of the anchor receivers to tissue of the heart by driving the corresponding anchor into the tissue.

[0088] In some implementations, the connector may extend within the lumen of the catheter parallel to the first and second shafts such that the shafts and connectors are all surrounded by the inner wall of the catheter. Because the connector is external to the shafts, the connector may be disposed in space within the lumen not occupied by the shafts.

[0089] In some implementations, the connector may be coupled to at least the distal end of the shaft, for example, by being disposed through a cuff attached to the shaft, In some implementations, the connector may define a flange dimensioned to maintain engagement between the connector and the cuff, and thereby between the cuff and the interface.

[0090] In some implementations, the connector may have a distal end that may be connected to the interface, for example, the distal end may be removably attached to the interface (e.g., via threads), which may allow the connector to be removed from the implant after the implant is secured to tissue.

[0091] In some implementations, the connectors can be connected to the interface in a manner that maintains each of the anchor receivers aligned with the distal opening of a corresponding one of the shafts. For example, the distal opening of the shaft can be aligned with the anchor receivers such that a driver can advance an anchor directly into the anchor receiver. Additionally, the connectors can be removably attached to the interface such that separation of the connector from the interface can release the implant from the delivery tool.

[0092] In some implementations, a system and / or device (e.g., that may be used in a live subject or a simulated heart) may include an implant, two anchors, and a delivery tool. In some implementations, the system may include (i) a delivery tool including a shaft (e.g., a single shaft) and a connector (e.g., a single connector) coupled to the shaft, (ii) an implant including multiple anchor receivers and corresponding multiple interfaces, and (iii) multiple anchors, each advanced through the shaft to secure a corresponding anchor receiver. In some implementations, a connection between the connector and the multiple interfaces may initially maintain the multiple anchor receivers aligned with the distal opening of the shaft and may facilitate selective deployment (e.g., disalignment) of the anchor receivers during anchoring.

[0093] In some implementations, each of the multiple anchor receivers may have a different aperture size (e.g., width / diameter), and each of the multiple anchors may have a different head size (e.g., width / diameter) such that the head size of each anchor is compatible with the aperture size of the corresponding anchor receiver. For example, in some implementations, a first anchor receiver to be fixed may have a smaller aperture size than a second anchor receiver to be fixed, and the first anchor (used to fix the first anchor receiver) may have a smaller aperture size than the second anchor (used to fix the second anchor receiver).

[0094] In some implementations, the head size of the first anchor can be smaller than the aperture size of the second anchor receiver (but e.g., larger than the aperture size of the first anchor receiver), e.g., the first anchor can be advanced completely through the second anchor receiver to reach and secure in the second anchor receiver. However, in some implementations, the head size of the second anchor can be larger than the aperture size of the second anchor receiver, e.g., the second anchor can secure the second anchor receiver.

[0095] In some implementations, the system may include an anchor, a delivery tool, and an implant, which may include two or more anchor receivers and thus may be similar to the implants disclosed herein and / or variations thereof, mutatis mutandis, at least in its generality, except that the presently disclosed implants may include two anchor receivers having different aperture sizes and two interfaces. For example, the implant may include, among other components, two anchor receivers, e.g., a first anchor receiver defining a first aperture and a second anchor receiver defining a second aperture.

[0096] In some implementations, each of the anchor receivers may be connected to a corresponding interface, e.g., a first interface may be connected to a first anchor receiver and a second interface may be connected to a second anchor receiver.

[0097] In some implementations, each anchor can have a head and a tissue-engaging element, e.g., a first anchor can have a first head and a first tissue-engaging element and a second anchor can have a second head and a second tissue-engaging element, In some implementations, the first head can be smaller (e.g., in diameter) than the second head.

[0098] In some implementations, the second opening may be wider than the first opening. In some implementations, the first head may be sized to pass through but be blocked by the first opening, while the second head may be sized to be blocked by the second opening.

[0099] In some implementations, the delivery tool can include a connector having a distal end that can be connected to the first and second interfaces, among other components. The connector can be connected to the interfaces in a manner that maintains both anchor receivers aligned with the distal opening of the shaft. For example, the connector can be connected to the interfaces in a manner that maintains the first and second anchor receivers stacked with the first and second openings aligned with one another and the distal opening of the shaft.

[0100] In some implementations, at least one driver of the delivery tool can be configured to secure the first anchor receiver to a first tissue site of the heart. For example, the first anchor can be advanced through the shaft, completely through the second opening (e.g., without the anchor engaging the second anchor receiver), and drive its driven tissue engaging element (but not its head) through the first opening and into the first tissue site, thereby securing the first anchor receiver to the first site.

[0101] In some implementations, once the first anchor receiver is secured, the connector may be disconnected from the first interface while remaining connected to the second interface, thereby facilitating movement of the second anchor receiver away from the first anchor receiver, for example, to a second tissue site in the heart. The driver may then secure the second anchor receiver to the second tissue site, for example, by advancing a second tissue engaging element through the shaft and driving the tissue engaging element (but not its head) through the second opening and into the second tissue site.

[0102] In some implementations, the system and / or device (which may be used in a heart, e.g., a valve in a live subject or a simulated heart) includes an implant, at least one anchor, and a delivery tool (or delivery system).

[0103] The valve can have a first leaflet and an opposing leaflet, e.g., a second leaflet.The heart has a chamber upstream of the valve.

[0104] In some implementations, the implant includes a wing, hi some implementations, the wing defines a contact surface and a facing surface opposite the contact surface and includes a flexible frame.

[0105] In some implementations, the implant also includes at least one anchor receiver. In some implementations, the at least one anchor receiver includes a first anchor receiver and a second anchor receiver. In some implementations, additional anchor receivers may also be included. In some implementations, each of the anchor receivers is coupled to a wing and configured to be secured to an annulus of the valve.

[0106] In some implementations, the anchor receiver is configured to be secured to the annulus of the valve with the wings extending away from the anchor receiver and over the first leaflet toward the opposing leaflet, and with the contact surface facing the first leaflet.

[0107] In some implementations, the at least one anchor includes a first anchor and a second anchor configured to be coupled to the wing via the first and second anchor receivers, hi some implementations, the anchor may be implantable at a site upstream of the valve and / or may be configured to support an implant.

[0108] In some implementations, the delivery tool or system includes a catheter transluminally advanceable to the chamber. In some implementations, the delivery tool includes a first shaft and a second shaft disposed parallel to one another. In some implementations, the first shaft and the second shaft are disposed within the catheter. In some implementations, each of the first shaft and the second shaft engages with a corresponding anchor receiver (e.g., the first shaft engaging with the first anchor receiver and the second shaft engaging with the second anchor receiver).

[0109] In some implementations, the first shaft and the second shaft are configured to deploy the implant out of the catheter within the chamber via engagement with a corresponding anchor receiver such that the wings extend away from the anchor receiver, and to position the implant in a position where the first anchor receiver is at a first location of the heart and the second anchor receiver is at a second location of the heart, the wings extend over the first leaflet toward the opposing leaflet, and the contact surface faces the first leaflet.

[0110] In some implementations, the delivery tool or system includes a first driver and a second driver, each driver engaging a corresponding anchor (e.g., a first anchor and a second anchor). In some implementations, the delivery tool or system is configured to secure the implant in place by using the first anchor to secure the first anchor receiver to tissue of the heart at a first location and using the second anchor to secure the second anchor receiver to tissue of the heart at a second location.

[0111] In some implementations, the implant is sterile. In some implementations, the delivery tool is sterile. In some implementations, the first anchor and the second anchor are sterile.

[0112] In some implementations, the frame defines a tuning node that is connected to a tether that extends from the tuning node to another portion of the wing, such that increasing tension in the tether decreases the distance between the tuning node and the other portion of the wing.

[0113] In some implementations, the delivery tool further includes a dry balance configured to stabilize the delivery tool with tissue.

[0114] In some implementations, the delivery tool is configured to simultaneously position the first driver and the second driver within the chamber of the heart.

[0115] In some implementations, the implant further includes a plurality of barbs extending from the contact surface.

[0116] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0117] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0118] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0119] In some implementations, the flexibility of the frame can allow the distance between the first anchor receiver and the second anchor receiver to be altered within the heart.

[0120] In some implementations, the distance between the first anchor receiver and the second anchor receiver can be varied within the heart by positioning the first anchor receiver at a first location by a first shaft and by positioning the second anchor receiver at a second location by a second shaft.

[0121] In some implementations, the distance between the first anchor receiver and the second anchor receiver can be fixed by anchoring of the second anchor with a second driver at a second site of the heart relative to anchoring of the first anchor at the first site.

[0122] In some implementations, (i) the implant further includes an interface adjacent at least one of the first and second anchor receivers, and (ii) the delivery tool includes a connector that (1) extends within the lumen of the catheter parallel to the first and second shafts and (2) has a distal end connected to the interface in a manner that (i) maintains at least one of the first and second anchor receivers in alignment with a corresponding distal opening of one of the shafts, and (ii) such that separation of the connector from the interface releases the implant from the delivery tool.

[0123] In some implementations, the implant further includes a third anchor receiver such that a distal end of the connector is connected to the interface adjacent the third anchor receiver.

[0124] In some implementations, the system further includes a third shaft that is transluminally slidable over and along the connector into the third anchor receiver.

[0125] In some implementations, the implant further includes a lance attached to the first anchor receiver and configured to stabilize the implant relative to tissue.

[0126] In some implementations, engagement between the first shaft and the first anchor receiver maintains the lance in the deformed position.

[0127] In some implementations, the lance is biased towards the rest position such that the lance moves towards the rest position in response to disengagement of the first shaft from the first anchor receiver.

[0128] In some implementations, the implant further includes an adjustment element extending from the first anchor receiver to the second anchor receiver and configured to facilitate intracardiac variation of the distance between the first anchor receiver and the second anchor receiver.

[0129] In some implementations, the delivery tool further includes an adjustment actuator configured to adjust a length of the adjustment element.

[0130] In some implementations, the tuning element is a compression member.

[0131] In some implementations, the adjustment element is a tether.

[0132] According to some implementations, the system and / or device (which may be used with a heart, e.g., a valve in a live subject or a simulated heart) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant may include flexible wings, an anchor receiver, and / or an attachment element, among other components.

[0133] In some implementations, the flexible wing may have a root portion and / or a tip portion and may define a first (eg, contact) surface and a second surface opposite the first surface.

[0134] In some implementations, the anchor receiver may be coupled to the root portion of the wing and may be configured to receive the anchor and / or be configured to be secured by the anchor.

[0135] In some implementations, the attachment element may be configured to be attached to the labial edge of the first leaflet and / or may be positioned at a tip portion.

[0136] In some implementations, multiple anchor receivers and multiple anchors can be included.

[0137] The valve of the heart may have an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet, and / or the heart may have a chamber upstream of the valve.

[0138] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter is transluminally advanceable into the chamber.

[0139] In some implementations, the shaft may be configured to engage with the anchor receiver and / or, via engagement with the anchor receiver, (i) deploy the implant out of the catheter and / or (ii) position the implant at a location where the anchor receiver may be at a site within the heart and / or where the wings may extend over the first leaflet towards the opposing leaflet with the first (e.g., contact) surface facing the first leaflet.

[0140] In some implementations, the driver can be configured to secure the implant in place by engaging the anchor and / or using the anchor to secure the anchor receiver to tissue of the heart.

[0141] In some implementations, the delivery tool can be configured to attach the attachment element to the labial edge of the first leaflet.

[0142] In some implementations, the implant is sterile, in some implementations, the anchor is sterile, in some implementations, the delivery tool is sterile.

[0143] In some implementations, the attachment element includes a clip, the clip having an open state and a closed state.

[0144] In some implementations, the clip is articulably coupled to a tip portion of the wing.

[0145] In some implementations, the system / apparatus further includes (i) a tether connected to the clip, and (ii) a rod connected to the tether and operable by the delivery tool in a manner to actuate the clip to transition between an open state and an occluded state by changing the amount of tension in the tether.

[0146] In some implementations, the rod is a component of an implant.

[0147] In some implementations, the tether is a component of the implant.

[0148] In some implementations, the delivery tool is configured to actuate the clip by sliding a rod longitudinally along the wings.

[0149] In some implementations, the rod is connected to the clip via a tether such that in the open configuration, the rod extends beyond the tip portion of the wing.

[0150] In some implementations, the catheter is configured to accommodate the implant.

[0151] In some implementations, the implant has a delivery configuration in which the attachment element is adjacent the first surface.

[0152] In some implementations, the anchor receiver is configured to be secured to the annulus in a manner such that the wings extend away from the anchor receiver and over the first leaflet toward the opposing leaflet, with the first surface facing the first leaflet and the second surface facing the chamber.

[0153] In some implementations, the shaft is configured to position the implant in a position such that the attachment element is at the labial edge region of the first leaflet.

[0154] In some implementations, the delivery tool further includes a tip driver configured to position the attachment element at a lip edge region of the first leaflet.

[0155] In some implementations, the tip driver is configured to attach the attachment element to the first leaflet at a labial edge region of the first leaflet.

[0156] In some implementations, the system is for further use with a distal anchor, where (i) the anchor receiver is a root anchor receiver, (ii) the anchor is a root anchor, and (iii) the attachment element is a distal anchor receiver configured to receive the distal anchor and secured to the first leaflet by the distal anchor.

[0157] In some implementations, the root anchor is a first root anchor and the implant further includes a second root anchor.

[0158] According to some implementations, the system and / or device (which may be used with a heart, e.g., a valve in a live subject or a simulated heart) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant may include flexible wings and / or an anchor receiver, among other components.

[0159] In some implementations, the flexible wing may have a root portion and / or a tip portion and may define a first (eg, contact) surface and a second surface opposite the first surface.

[0160] In some implementations, the anchor receiver may be coupled to the root portion of the wing and / or may be configured to receive an anchor and / or may be configured to be secured by an anchor. In some implementations, multiple anchor receivers and multiple anchors may be included.

[0161] The system / device may be configured for use with a valve of the heart, the valve of the heart may have an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet, and / or the heart may have a first chamber upstream of the valve and a second chamber downstream of the valve.

[0162] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter can be transluminally advanceable into the first chamber. In some implementations, the shaft can be configured to engage an anchor receiver and, via engagement with the anchor receiver, (i) deploy the implant out of the catheter, and (ii) position the implant in a location.

[0163] In that position, the anchor receiver may be at a site within the heart and / or the wing may extend over the first leaflet toward the opposing leaflet, with the first surface (e.g., the contact surface) facing the first leaflet.

[0164] In some implementations, the driver can be configured to secure the implant in place by engaging the anchor and / or using the anchor to secure the anchor receiver to tissue of the heart.

[0165] In some implementations, the system includes a rod that engages the implant and is operable by the delivery tool to alter a structure of the implant through engagement with the implant.

[0166] In some implementations, the implant is sterile, in some implementations, the anchor is sterile, in some implementations, the delivery tool is sterile.

[0167] In some implementations, the rod is a component of an implant.

[0168] In some implementations, the delivery tool is configured to modify the structure of the implant by extending the rod beyond the tip portion of the wing.

[0169] In some implementations, (i) the implant includes a clip attached to a tip portion of the wing and configured to be attached to a lip edge of the first leaflet, and (ii) the rod is operable by the delivery tool to transition the clip between an open configuration and a closed configuration.

[0170] In some implementations, the delivery tool is configured to facilitate a driver to secure the implant in place prior to attaching the clip to the labial edge of the first leaflet.

[0171] In some implementations, the delivery tool is configured to facilitate a driver to secure the implant in place following attachment of the clip to the labial edge of the first leaflet.

[0172] In some implementations, the clip is articulably coupled to a tip portion of the wing.

[0173] In some implementations, the system includes (i) a tether connected to the clip, and (ii) a rod connected to the tether and operable by the delivery tool in an actuated manner to transition the clip between an open configuration and a closed configuration by changing the amount of tension in the tether.

[0174] In some implementations, the tether is a component of the implant.

[0175] In some implementations, the delivery tool is configured to actuate the clip by sliding a rod longitudinally along the wings.

[0176] In some implementations, the rod is connected to the clip via a tether such that in the released state, the rod extends beyond the tip portion of the wing.

[0177] In some implementations, (i) the rods act as legs or extensions extending from the tip portions of the wings, and (ii) the rods are operable by a delivery tool to transition between (1) a storage structure and (2) an extended structure in which contact portions of the legs contact tissue in the second chamber while the implant is in position.

[0178] In some implementations, (i) the tissue of the second chamber is a wall of the second chamber, and (ii) the expansion structure is such that the contact portion of the leg contacts the wall of the second chamber while the implant is in position.

[0179] In some implementations, (i) the tissue of the second chamber is a papillary muscle, and (ii) the expansion structure is such that the contact portion of the leg contacts the papillary muscle while the implant is in place.

[0180] In some implementations, the delivery tool is configured to advance the implant into the first chamber while the rod is in the storage structure.

[0181] In some implementations, (i) the implant defines a frame, the frame providing mechanical support to the wings, and (ii) the delivery tool is configured to transition the rod from the stored configuration to the expanded configuration by advancing the rod longitudinally relative to the frame.

[0182] In some implementations, (i) the leg has an end and extends from a tip portion to an end, and (ii) along the leg, the end extends beyond the contact portion.

[0183] In some implementations, the contact portion extends laterally further than the wing.

[0184] In some implementations, the legs are configured such that (i) the implant is fixed in position and (ii) while the rod is in the expanded configuration, contact between a contact portion of the legs and tissue in the second chamber limits pivoting of the wing about the anchor.

[0185] In some implementations, the legs are configured such that (i) the implant is fixed in position and (ii) while the rod is in the expanded configuration, contact between a contact portion of the leg and tissue of the second chamber limits the wing's pivoting about the site of the annulus.

[0186] According to some implementations, the system and / or device (which may be used with a heart, e.g., a valve in a live subject or a simulated heart) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant may include flexible wings and / or an anchor receiver, among other components.

[0187] In some implementations, the flexible wing can have a root portion and a tip portion and can define a first (eg, contact) surface and a second surface opposite the first surface.

[0188] In some implementations, the anchor receiver may be coupled to the wing root portion and / or configured to receive an anchor and / or be secured by an anchor. In some implementations, multiple anchor receivers and multiple anchors may be included.

[0189] The system / device may be configured for use with a valve of the heart, the valve of the heart may have an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet, and / or the heart may have a first chamber upstream of the valve and a second chamber downstream of the valve.

[0190] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter is transluminally advanceable into the first chamber.

[0191] In some implementations, the shaft can be configured to engage with the anchor receiver and, through engagement with the anchor receiver, (i) deploy the implant out of the catheter, and (ii) position the implant at a position where the anchor receiver is at a site within the heart, the wings extend over the first leaflet toward the opposing leaflet, and the first surface (e.g., the contact surface) faces the first leaflet.

[0192] In some implementations, the driver can be configured to engage the anchor and secure the implant in place by using the anchor to secure the anchor receiver to the tissue of the heart.

[0193] In some implementations, the implant is sterile, in some implementations, the anchor is sterile, in some implementations, the delivery tool is sterile.

[0194] In some implementations, the implant defines a frame that provides mechanical support to the wings and defines the legs or extensions.

[0195] In some implementations, the delivery tool is configured to have legs extending from the tip portion into the heart.

[0196] In some implementations, the legs are configured such that contact portions of the legs contact tissue in the second chamber while the implant is fixed in position.

[0197] In some implementations, the end portion extends from the tip portion along the leg and beyond the contact portion.

[0198] In some implementations, the contact portion is not at the end portion.

[0199] In some implementations, the contact portion extends laterally further than the wing.

[0200] In some implementations, the legs are configured such that contact between a contact portion of the leg and tissue of the second chamber limits the wing from pivoting about the anchor while the implant is fixed in position.

[0201] In some implementations, the legs are configured such that while the implant is fixed in position, the legs are at least partially attracted to forces exerted on the implant by cardiac tissue, resulting in a reversible change in shape of the legs as the second chamber contracts and expands during the cardiac cycle.

[0202] In some implementations, the leg defines an articulation portion articulably connecting the tip portion of the wing to an end portion of the leg, the articulation portion being more flexible than the end portion.

[0203] In some implementations, the articulation portion is elastic.

[0204] In some implementations, the articulation portion defines a hinge.

[0205] In some implementations, the articulation portion defines a torsion spring.

[0206] In some implementations, the articulation portion defines a bend.

[0207] In some implementations, (i) the legs have a first length and a second length, and (ii) the delivery tool is configured to extend the legs within the heart from the first length to the second length.

[0208] In some implementations, the second length is greater than the first length and the delivery tool is configured to advance the implant into the chamber while the legs have the first length.

[0209] In some implementations, the implant defines a frame having (i) a stationary portion that provides mechanical support to the wing, and (ii) a sliding portion that defines the legs.

[0210] In some implementations, the delivery tool is configured to extend the legs within the heart from a first length to a second length by longitudinally advancing the sliding portion relative to the stationary portion.

[0211] In some implementations, the implant is configured such that (i) the implant is fixed in position and (ii) the contact portions of the legs contact tissue in the second chamber while the legs are extended to the second length.

[0212] In some implementations, the end portion extends from the tip portion along the leg and beyond the contact portion.

[0213] In some implementations, the contact portion is not at the end portion.

[0214] In some implementations, the contact portion extends laterally further than the wing.

[0215] In some implementations, the legs are configured such that, while the implant is fixed in position and the legs are extended to the second length, contact between a contact portion of the leg and tissue of the second chamber limits the wing from pivoting about the site of the annulus.

[0216] In some implementations, the legs are configured such that while the implant is fixed in position and the legs are extended to the second length, the legs are at least partially attracted to forces exerted on the implant by cardiac tissue, resulting in a reversible change in shape of the legs as the second chamber contracts and expands during the cardiac cycle.

[0217] In some implementations, the leg defines an articulation portion articulably connecting the tip portion of the wing to an end portion of the leg, the articulation portion being more flexible than the end portion.

[0218] According to some implementations, the system and / or device (which may be used in a valve of the heart, e.g., a living subject or a simulated heart) includes an implant including a contact surface and an opposing surface opposing the contact surface, wings defining a flexible frame, and a first anchor receiver and a second anchor receiver.

[0219] The system / device may be configured for use with a valve of the heart. The valve may have a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0220] In some implementations, each anchor receiver may be coupled to a wing and / or configured to be secured to tissue of the valve annulus in a manner such that the wings extend away from the first and second anchor receivers, toward the opposing leaflet, and over the first leaflet, with the contact surface facing the first leaflet.

[0221] In some implementations, the flexibility of the frame facilitates intracardiac change of the position of the second anchor receiver relative to the first anchor receiver.

[0222] In some implementations, the frame defines first and second portions of the wings and is configured to facilitate intracardiac change in the position of the second anchor receiver relative to the first anchor receiver by facilitating a change in overlap between the first and second portions.

[0223] In some implementations, the implant further includes a plurality of barbs extending from the contact surface.

[0224] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0225] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0226] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0227] In some implementations, the system / device further includes a third anchor receiver coupled to the wing and configured to be secured to the annulus of the valve.

[0228] In some implementations, the wing includes a braided mesh disposed over a flexible frame.

[0229] In some implementations, the flexible frame is defined by a braided mesh.

[0230] In some implementations, the wing is configured to guide the first leaflet into coaptation with the opposing leaflet.

[0231] In some implementations, the frame comprises a polymer.

[0232] In some implementations, the implant further includes at least one lance attached to at least one of the first and second anchor receivers and configured to stabilize the implant relative to tissue.

[0233] In some implementations, the wing has a root portion and a tip portion, and the implant further includes an attachment element at the tip portion configured to be attached to the labial edge of the first leaflet.

[0234] In some implementations, the wing has a root portion and a tip portion, and the implant further includes an attachment element at the tip portion configured to be attached to the labial edge of the opposing leaflet.

[0235] In some implementations, the attachment element is pivotally coupled to the wing.

[0236] In some implementations, the attachment element includes a jaw.

[0237] In some implementations, the attachment element is configured to be attached to the lip edge of the opposing leaflet by pinching the lip edge of the opposing leaflet against the tip portion.

[0238] In some implementations, the attachment element further includes a leaflet anchor coupled to the jaw and configured to be driven through the opposing leaflet, thereby securing the attachment element to the opposing leaflet.

[0239] In some implementations, the jaw is a first jaw and the attachment element further includes a second jaw, the first and second jaws configured to securely attach the lip edges of the opposing leaflets by clamping the lip edges of the opposing leaflets between the first jaw and the second jaw.

[0240] In some implementations, the first jaw is biased relative to the wing to move toward the second jaw.

[0241] In some implementations, the second jaw is biased relative to the wing to move toward the first jaw.

[0242] In some implementations, the second jaw is pivotally fixed relative to the first jaw such that the second jaw is moveable relative to the first jaw.

[0243] In some implementations, the system / apparatus further includes (i) an anchor and (ii) a delivery tool including (1) a catheter transluminally advanceable to the chamber and configured to receive the implant, and (2) a shaft engaged with the anchor receiver.

[0244] In some implementations, the shaft is configured, through engagement with the anchor receiver, to (i) deploy the implant out of the catheter within the chamber such that the wings extend away from the anchor receiver and the attachment elements extend away from the wings, and (ii) position the implant at a location within the heart such that the anchor receiver is at a site with the wings extending over a first leaflet toward the opposing leaflet and the contact surface facing the first leaflet.

[0245] In some implementations, the driver is configured to secure the implant in place by engaging the anchor and using the anchor to secure the anchor receiver to the tissue of the heart.

[0246] In some implementations, the delivery tool is configured to attach the attachment element to the lip edge of the opposing leaflet.

[0247] In some implementations, the shaft is configured to position the implant in a position such that the attachment elements are at the labial edge regions of the opposing leaflets.

[0248] In some implementations, the delivery tool further includes a tip driver configured to position the attachment element at the lip edge region of the opposing leaflet.

[0249] In some implementations, the tip driver is configured to attach the attachment element to the opposing leaflet at a lip edge region of the opposing leaflet.

[0250] In some implementations, the system / apparatus further includes (i) a catheter transluminally advanceable into the chamber and configured to house the implant; and (ii) a delivery tool configured to deploy the implant out of the catheter within the chamber such that the wings extend away from the first anchor receiver and the second anchor receiver.

[0251] In some implementations, the delivery tool includes (i) a first shaft coupled to the first anchor receiver and configured to position the first anchor receiver at a first location on the tissue; (ii) a second shaft coupled to the second anchor receiver and configured to position the first anchor receiver at a second location on the tissue; (iii) a first driver slidable through the first shaft and configured to secure the first anchor receiver at the first location; and (iv) a second driver slidable through the second shaft and configured to secure the second anchor receiver at the second location.

[0252] In some implementations, the delivery tool is configured to change the position of the second anchor receiver relative to the first anchor receiver within the heart.

[0253] In some implementations, the delivery tool is configured to alter the position of the second anchor receiver relative to the first anchor receiver within the heart prior to fixation of the first anchor receiver and prior to fixation of the second anchor receiver.

[0254] In some implementations, the delivery tool is configured to change the position of the second anchor receiver relative to the first anchor receiver within the heart after fixation of the first anchor receiver and before fixation of the second anchor receiver.

[0255] In some implementations, the delivery tool is configured to change the position of the second anchor receiver relative to the first anchor receiver within the heart after fixation of the first anchor receiver and after fixation of the second anchor receiver.

[0256] In some implementations, the system / apparatus further includes a first anchor and a second anchor, and (i) the first driver is configured to advance the first anchor out of the first shaft and secure the first anchor receiver to the first location by driving a tissue engaging element of the first anchor through the second anchor receiver and into tissue at the first location, and (ii) the second driver is configured to advance the second anchor out of the second shaft and secure the second anchor receiver to the second location by driving a tissue engaging element of the second anchor through the second anchor receiver and into tissue at the second location.

[0257] In some implementations, for each of the first and second shafts, (i) at a distal end of the shaft, the shaft has an engagement portion that engages with the anchor receiver, (ii) the engagement portion is biased to disengage from the anchor receiver, and (iii) a respective anchor is disposed in the engagement portion and prevents the engagement portion from disengaging from the anchor receiver.

[0258] In some implementations, for each of the first and second shafts, the respective driver is configured to disengage the shaft from the respective anchor receiver by advancing the respective anchor out of the shaft such that the engagement portion responsively disengages from the anchor receiver.

[0259] In some implementations, the flexibility of the frame facilitates intracardiac variation of the distance between the second anchor receiver and the first anchor receiver.

[0260] In some implementations, the frame is configured to facilitate intracardiac changes in distance by changing shape in response to forces applied thereto.

[0261] In some implementations, the frame is configured to facilitate intracardiac change in distance by changing shape in response to a compressive force that urges the second anchor receiver closer to the first anchor receiver.

[0262] In some implementations, the frame is configured to facilitate intracardiac change in distance by changing shape in response to an expansive force that urges the second anchor receiver away from the first anchor receiver.

[0263] In some embodiments, the frame is configured such that intracardiac changes in the position of the second anchor receiver relative to the first anchor receiver adjust the width of the frame.

[0264] In some implementations, the frame is configured such that intracardiac changes in the position of the second anchor receiver relative to the first anchor receiver adjust the width of the wing.

[0265] In some implementations, the flexibility of the frame facilitates intracardiac changes in orientation between the second anchor receiver and the first anchor receiver.

[0266] In some implementations, the frame is configured to facilitate intracardiac changes in orientation by changing shape in response to an external force applied thereto.

[0267] In some implementations, the system / apparatus further includes a coordination element extending between the first anchor receiver and the second anchor receiver.

[0268] In some implementations, the adjustment element is configured to apply a force to the frame, and the frame is configured to facilitate an intracardiac change in distance in response to the force applied by the adjustment element.

[0269] In some implementations, the adjustment element is a tension member.

[0270] In some implementations, the tension member is a tether.

[0271] In some implementations, the tuning element is a compression member.

[0272] In some implementations, the tuning element is a rigid element.

[0273] In some implementations, the frame comprises a metal.

[0274] In some implementations, the frame comprises a shape memory alloy.

[0275] In some implementations, the wing further includes a sheet disposed over the frame.

[0276] In some implementations, the sheet defines a plurality of holes therethrough, the holes being configured to facilitate blood flow through the wing.

[0277] In some implementations, (i) the wing extends from the wing root to the wing tip, (ii) the first anchor receiver and the second anchor receiver are disposed at the wing root, and (iii) the sheet extends from the tip toward the root at least halfway.

[0278] In some implementations, the sheet terminates midway through the root, thereby defining an uncovered zone of the wing proximate the root.

[0279] In some implementations, the sheet comprises at least one material selected from the group consisting of polylactic-co-glycolic acid, polyvinyl chloride, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyethersulfone, polyglycolic acid, polylactic acid, poly-D-lactide, poly-4-hydroxybutyrate, and polycaprolactone.

[0280] In some implementations, the system / apparatus further includes (i) a first anchor configured to be received by the first anchor receiver and secure the first anchor receiver to a first location on the tissue, and (ii) a second anchor configured to be received by the first anchor receiver and secure the first anchor receiver to the first location on the tissue.

[0281] In some implementations, for each of the first anchor and the second anchor, the anchor includes (i) a tissue engaging element configured to be driven through a respective anchor receiver and into tissue, and (ii) a head configured to be retained by the anchor receiver.

[0282] In some implementations, (i) the first anchor receiver defines a first opening therethrough, with the head of the first anchor being wider than the first opening, (ii) the second anchor receiver defines a second opening therethrough, with the second opening being wider than the head of the first anchor, and (iii) the head of the second anchor being wider than the second opening.

[0283] In some implementations, the system / apparatus further includes a delivery tool including: (i) a connector configured to hold the first anchor receiver and the second anchor receiver aligned in a stack; (ii) a shaft coupled to the connector in a manner to align a distal opening of the shaft with the first opening and the second opening; and (iii) an anchor driver configured to advance the first anchor through the shaft and the second opening and secure the first anchor receiver at the first site by driving a tissue engaging element of the first anchor through the first opening and into tissue.

[0284] In some implementations, (i) the connector is configured to selectively release the first anchor receiver after securing the first anchor receiver at the first location and facilitate repositioning of the second anchor receiver to the second location, and (ii) the anchor driver is configured to secure the second anchor receiver at the second location by advancing the second anchor through the shaft and driving a tissue engaging element of the second anchor through the second opening and into tissue.

[0285] In some implementations, the first anchor is defined by a first leg of the staple and the second anchor is defined by a second leg of the staple, the staple further defining an intermediate section connecting the first leg and the staple.

[0286] In some implementations, the central section is adjustable in length.

[0287] In some implementations, the implant further includes a mounting indicator configured to indicate engagement between at least one of the first and second anchor receivers and cardiac tissue.

[0288] In some implementations, the attachment indicator is a mechanical pressure indicator.

[0289] In some implementations, the attachment indicator is an electrical pressure indicator.

[0290] In some implementations, the attachment indicator includes a spring connected to at least one of the first and second anchor receivers.

[0291] In some implementations, (i) the attachment indicator includes a hollow needle having an outlet and fixedly positioned relative to at least one of the first and second anchor receivers such that placing at least one of the first and second anchor receivers against tissue causes the outlet to be positioned within the tissue, and (ii) the system / device further includes a dispenser in fluid communication with the needle and configured to dispense the contrast agent out of the outlet.

[0292] In some implementations, the implant further includes a pressure sensor configured to detect blood pressure, hi some implementations, the pressure sensor is configured to measure left atrial pressure.

[0293] In some implementations, the pressure sensors are located on opposing surfaces of the wing.

[0294] In some implementations, the implant further includes a transmitter configured to wirelessly transmit a signal indicative of the detected blood pressure.

[0295] According to some implementations, the system and / or device (which may be used in a valve of a heart, e.g., a live subject or a simulated heart) includes an implant including a wing defining a contact surface and an opposing surface opposing the contact surface. The valve may have a first leaflet and an opposing leaflet, and / or a heart having a chamber upstream of the valve. The anchor receiver may be coupled to the wing and configured to be secured to the annulus of the valve in a manner that the wing extends away from the anchor receiver and toward the opposing leaflet on the first leaflet, and the contact surface faces the first leaflet. The wing may include a flexible frame defining an adjustment node that may be connected to an adjustment element extending from the adjustment node to another portion of the implant. The adjustment element may be configured to facilitate an intracardiac change in a distance between the adjustment node and another portion of the implant via application of a force on the frame by the adjustment element.

[0296] In some implementations, the other portion of the implant is an anchor receiver.

[0297] In some implementations, the other portion of the implant is a second anchor receiver.

[0298] In some implementations, another portion of the implant is a second tuning node.

[0299] In some implementations, the implant further includes a second anchor receiver.

[0300] In some implementations, the wings are a braided mesh.

[0301] In some implementations, the contact surface is configured to guide the first leaflet into coaptation with the opposing leaflet during ventricular contraction.

[0302] In some implementations, the tuning element is a compression member.

[0303] In some implementations, the tuning element is a rigid element.

[0304] In some implementations, the coordination node has a diameter smaller than that of the anchor receiver.

[0305] In some implementations, the frame comprises a polymer.

[0306] In some implementations, the system / device further includes an anchor configured to be received by the anchor receiver and driven into the annulus, thereby securing the anchor receiver to the annulus.

[0307] In some implementations, the implant further includes at least one lance attached to the anchor receiver and configured to stabilize the implant relative to tissue of the heart.

[0308] In some implementations, the frame is configured to facilitate intracardiac variation of the distance by changing shape in response to a force applied by the adjustment element.

[0309] In some implementations, the width of the frame is adjustable within the heart to a set distance between the adjustment node and other portions of the implant.

[0310] In some implementations, the wing width is adjustable within the heart relative to a set distance between the tuning node and other parts of the implant.

[0311] In some implementations, the implant further includes a plurality of barbs extending from the contact surface.

[0312] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0313] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0314] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0315] In some implementations, the adjustment element is a tension member.

[0316] In some implementations, the tension member is a tether.

[0317] In some implementations, the frame comprises a metal.

[0318] For some applications, the frame includes a shape memory material.

[0319] In some implementations, the wing further includes a sheet disposed over the frame.

[0320] In some implementations, the sheet defines a plurality of holes therethrough, the holes being configured to facilitate blood flow through the wing.

[0321] In some implementations, (i) the wing extends from the wing root to the wing tip, (ii) the anchor receiver is disposed at the wing root, and (iii) the seat extends from the tip at least part way towards the root.

[0322] In some implementations, the sheet terminates midway through the root, thereby defining an uncovered zone of the wing proximate the root.

[0323] In some implementations, the sheet comprises at least one sheet material selected from the group consisting of polylactic-co-glycolic acid, polyvinyl chloride, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyethersulfone, polyglycolic acid, polylactic acid, poly-D-lactide, poly-4-hydroxybutyrate, and polycaprolactone.

[0324] In some implementations, the system / device further includes a mounting indicator configured to indicate engagement between the anchor receiver and cardiac tissue.

[0325] In some implementations, the attachment indicator is a mechanical pressure indicator.

[0326] In some implementations, the attachment indicator is an electrical pressure indicator.

[0327] In some implementations, the attachment indicator includes a spring connected to the anchor receiver.

[0328] In some implementations, (i) the attachment indicator includes a hollow needle having an outlet and fixedly positioned relative to the anchor receiver such that placement of the anchor receiver against cardiac tissue results in the outlet being positioned within the tissue, and (ii) the system / device further includes a dispenser in fluid communication with the needle and configured to dispense contrast agent out of the outlet.

[0329] In some implementations, the implant further includes a pressure sensor configured to detect blood pressure.

[0330] In some implementations, the pressure sensor is configured to measure left atrial pressure.

[0331] In some implementations, the implant further includes a transmitter configured to wirelessly transmit a signal indicative of the detected blood pressure.

[0332] In some implementations, the wing has a root portion and a tip portion, and the implant further includes an attachment element at the tip portion configured to be attached to the labial edge of the opposing leaflet.

[0333] In some implementations, the attachment element is pivotally coupled to the wing.

[0334] In some implementations, the attachment element includes a jaw.

[0335] In some implementations, the attachment element is configured to be attached to the lip edge of the opposing leaflet by pinching the lip edge of the opposing leaflet against the tip portion.

[0336] In some implementations, the attachment element further includes a leaflet anchor coupled to the jaw and configured to be driven through the opposing leaflet, thereby securing the attachment element to the opposing leaflet.

[0337] In some implementations, the jaw is a first jaw and the attachment element further includes a second jaw, the first and second jaws configured to securely attach the lip edges of the opposing leaflets by clamping the lip edges of the opposing leaflets between the first jaw and the second jaw.

[0338] In some implementations, the first jaw is biased relative to the wing to move toward the second jaw.

[0339] In some implementations, the second jaw is biased relative to the wing to move toward the first jaw.

[0340] In some implementations, the second jaw is pivotally fixed relative to the first jaw such that the second jaw is moveable relative to the first jaw.

[0341] In some implementations, the system / apparatus further includes (i) an anchor, and (ii) a delivery tool.

[0342] In some implementations, the delivery tool includes (i) a catheter transluminally advanceable into the chamber and configured to receive the implant, and (ii) a shaft engaged with the anchor receiver.

[0343] In some implementations, the shaft is configured, through engagement with the anchor receiver, to (i) deploy the implant out of the catheter within the chamber such that the wings extend away from the anchor receiver and the attachment elements extend away from the wings, and (ii) position the implant at a location within the heart such that the anchor receiver is at a site with the wings extending over a first leaflet toward the opposing leaflet and the contact surface facing the first leaflet.

[0344] In some implementations, the delivery tool includes a driver configured to engage the anchor and secure the implant in place by using the anchor to secure the anchor receiver to the tissue of the heart.

[0345] In some implementations, the delivery tool is configured to attach the attachment element to the lip edge of the opposing leaflet.

[0346] In some implementations, the shaft is configured to position the implant in a position such that the attachment elements are at the labial edge regions of the opposing leaflets.

[0347] In some implementations, the delivery tool further includes a tip driver configured to position the attachment element at the lip edge region of the opposing leaflet.

[0348] In some implementations, the tip driver is configured to attach the attachment element to the opposing leaflet at a lip edge region of the opposing leaflet.

[0349] According to some implementations, a system and / or device (which may be used in a valve of a heart, e.g., a live subject or a simulated heart) includes an implant including a wing, a central anchor receiver, a first lateral anchor receiver, and a second lateral anchor receiver. In some implementations, the wing may define a contact surface and an opposing surface opposing the contact surface and may include a flexible frame.

[0350] In some implementations, the wing can include a first sheet and a second sheet, each of which spans a respective portion of the frame.

[0351] The valve of the heart may have a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0352] In some implementations, the central anchor receiver, the first side anchor receiver, and the second side anchor receiver are each coupled to wings and each configured to be secured to the valve annulus in a manner such that the wings extend away from the anchor receiver and over the first leaflet toward the opposing leaflet, with the contact surface facing in the direction of the first leaflet.

[0353] In some implementations, the frame can allow the distance between at least two of the anchor receivers to be varied within the heart in a manner that varies the overlap between the first sheet and the second sheet.

[0354] In some implementations, at least two of the first, second, and central anchor receivers are a first lateral anchor receiver and a second lateral anchor receiver.

[0355] In some implementations, at least two of the first, second, and central anchor receivers are a central anchor receiver and at least one of first and second side anchor receivers.

[0356] In some implementations, the wings are configured such that a change in distance between the first side anchor receiver and the second side anchor receiver changes a shape of the overlap between the first sheet and the second sheet.

[0357] In some implementations, the wings are configured such that a change in the distance between the first side anchor receiver and the second side anchor receiver changes the area of ​​overlap between the first sheet and the second sheet.

[0358] In some implementations, the frame is defined by a single flexible wire.

[0359] In some implementations, the wings are configured such that the width of the implant is determined by the distance between the first and second lateral anchor receivers.

[0360] In some implementations, the wings are configured such that a change in overlap changes the effective surface area of ​​the contact surfaces of the wings.

[0361] In some implementations, the wings are configured such that a change in overlap changes the width of the contact surface of the wings.

[0362] In some implementations, the implant further includes at least one lance attached to at least one of the first, second, and central anchor receivers and configured to stabilize the implant relative to tissue of the heart.

[0363] In some implementations, the implant further includes a plurality of barbs extending from the contact surface.

[0364] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0365] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0366] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0367] According to some applications, the system and / or device (which may be used, for example, in a live subject or simulated cardiac anchor) includes an implant, a hollow needle, and a dispenser. In some implementations, the implant includes an anchor receiver configured to be secured to cardiac tissue by the anchor.

[0368] In some implementations, the hollow needle has an outlet and is fixedly positioned relative to the anchor receiver such that placement of the anchor receiver relative to tissue causes the outlet to be disposed within the tissue.

[0369] In some implementations, the dispenser is in fluid communication with the needle and configured to dispense the contrast agent out of the outlet.

[0370] In some implementations, the hollow needle includes a first section including an outlet and configured to be inserted into tissue, and a second section opposite the first section in fluid communication with the dispenser and configured to be positioned within a chamber of the heart.

[0371] In some implementations, the hollow needle includes (i) a first section including an outlet configured to be inserted into tissue, and (ii) a second section opposite the first section that is in fluid communication with a dispenser configured to be positioned within a chamber of the heart.

[0372] In some implementations, the outlet is a plurality of outlets such that the first section is perforated.

[0373] In some implementations, (i) the dispenser includes a connection port positioned at a distal end of the dispenser configured to be in fluid communication with the second section, (ii) the second section of the needle includes a seal, and (iii) the connection port is configured to be removably attached to the seal to enable a sealed fluid communication connection between the dispenser and the second section of the needle.

[0374] In some implementations, the system further includes an anchor and a delivery tool including: (i) a shaft that engages with the anchor receiver, the shaft configured to, through engagement with the anchor receiver, (1) deploy the implant out of the catheter and (2) position the implant at a location where the anchor receiver is at a site within the heart; and (ii) a driver configured to engage with the anchor and secure the implant in its position by using the anchor to secure the anchor receiver to tissue of the heart such that the outlet is disposed within the tissue.

[0375] In some implementations, the dispenser is coupled to the shaft.

[0376] In some implementations, the hollow needle is secured to the anchor receiver.

[0377] In some implementations, the hollow needle is configured to stabilize the implant relative to the tissue.

[0378] In some implementations, the hollow needle is configured to prevent the implant from pivoting about the anchor receiver.

[0379] According to some implementations, the system and / or device (which may be used in a heart, e.g., a valve of a live subject or a simulated heart) includes an implant including a wing, a first anchor receiver, a second anchor receiver, a first anchor, a second anchor, and a rail.

[0380] The valve may have a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0381] In some implementations, the wing defines a contact surface and an opposing surface opposite the contact surface and includes a flexible frame. In some implementations, the first anchor receiver and the second anchor receiver are each coupled to the wing. In some implementations, the first anchor and the second anchor are implantable at a first site and a second site, respectively, of the valve annulus.

[0382] In some implementations, the rail extends from the first anchor to the second anchor, and the first anchor receiver and the second anchor receiver are coupled to the rail in a manner such that the wings extend away from the rail and over the first leaflet toward the opposing leaflet, with the contact surface facing the first leaflet.

[0383] In some implementations, the implant further includes a plurality of barbs extending from the contact surface.

[0384] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0385] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0386] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0387] In some implementations, the rails are flexible. In some implementations, the rails are rigid.

[0388] In some implementations, the rail has at least one rigid portion and at least one flexible portion.

[0389] In some implementations, a first portion of the rail is formed from a first material and a second portion of the rail is formed from a second material that is different from the first material.

[0390] In some implementations, the implant is implantable such that the wings are indirectly secured to the tissue of the heart.

[0391] In some implementations, the first and second anchor receivers are slidably coupled to the rail.

[0392] In some implementations, the system / apparatus further includes at least one stopper configured to be secured to the rail in a manner that prevents sliding of at least one of the first and second anchor receivers along the rail.

[0393] In some implementations, the rail is configured to facilitate intracardiac variation of the distance between the first anchor and the second anchor.

[0394] In some implementations, the rail is configured to facilitate intracardiac contraction of tissue between the first anchor and the second anchor via tension in the rail.

[0395] In some implementations, the rail is configured to facilitate intracardiac extension of tissue between the first anchor and the second anchor via increasing a length within the heart of the rail disposed between the first anchor and the second anchor.

[0396] According to some implementations, the system and / or device (which may be used, for example, in a living subject or a simulated tissue and / or heart) is an implant that includes a first anchor receiver and a second anchor receiver, and an interface adjacent to the first anchor receiver.

[0397] In some implementations, the implant is configured for use with the first anchor and / or the second anchor. In some implementations, the system / apparatus includes a first anchor and a second anchor.

[0398] In some implementations, a delivery tool or system includes a catheter defining a lumen, a first shaft and a second shaft extending parallel to one another through the lumen, each of the shafts terminating in a distal opening.

[0399] In some implementations, the delivery tool or system also includes a first driver and a second driver, each of the drivers configured to advance a corresponding one of the anchors through a corresponding one of the shafts and secure a corresponding one of the anchor receivers to tissue of the heart by driving the corresponding anchor into the tissue.

[0400] In some implementations, the delivery tool or system also includes a connector extending within the lumen parallel to the first and second shafts and having a distal end connected to the interface in a manner that (i) maintains each of the anchor receivers aligned with the distal opening of a corresponding one of the shafts, and (ii) such that separation of the connector from the interface causes the implant to be released from the delivery tool.

[0401] In some implementations, the distal end of the connector is removably attached to the interface.

[0402] In some implementations, the distal end of the interface is connected to the interface via complementary threads defined by the distal end of the connector and the interface.

[0403] In some implementations, the implant further includes a wing having a first anchor receiver and a second anchor receiver coupled thereto, the wing including a flexible frame, the frame being deformable such that the distance between the first anchor receiver and the second anchor receiver is alterable within the heart.

[0404] In some implementations, (i) the heart tissue includes heart valve annulus tissue, (ii) the implant includes a wing defining (1) a contact surface and an opposing surface opposing the contact surface, and (2) a plurality of barbs extending from the contact surface, and (iii) the implant is configured to be implanted at a location where the anchor receiver is on the annulus, the wing extending over a first leaflet toward the opposing leaflet, and the plurality of barbs facing the first leaflet.

[0405] In some implementations, the barbs are configured to progressively pierce the first leaflet during the course of one or more cardiac cycles of the heart while the implant is implanted in position.

[0406] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0407] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0408] In some implementations, (i) the implant further includes a second interface adjacent to the second anchor receiver, and (ii) the delivery tool further includes a second connector extending within the lumen parallel to the first and second shafts and the first connector and having a distal end connected to the second interface.

[0409] In some implementations, the delivery tool further includes a first cuff and a second cuff, each cuff secured to a distal end of a corresponding one of the first shaft and the second shaft.

[0410] In some implementations, the first and second connectors each have a distal end configured to thread through a corresponding one of the first and second cuffs and connect to a corresponding one of the interfaces to secure the implant to the delivery tool.

[0411] In some implementations, the lumen is dimensioned to facilitate simultaneous advancement therethrough of the first and second shafts and the first and second connectors.

[0412] In some implementations, the delivery tool further includes a cuff secured to a distal end of at least one of the first shaft and the second shaft.

[0413] In some implementations, the connector has a distal end configured to thread through the cuff and connect to the interface to secure the implant to the delivery tool.

[0414] According to some implementations, the system and / or device (which may be used in a valve of a heart, e.g., a live subject or a simulated heart) includes an anchor, an anchor receiver, and a delivery tool / system. In some implementations, the anchor receiver includes a tube sized to allow the anchor to pass therethrough and defines a receiver coupling on an outer surface of the tube.

[0415] In some implementations, the delivery tool or system includes a shaft defining an internal lumen having a central longitudinal axis, hi some implementations, the delivery tool or system defines a midplane at a distal end of the shaft on which the central longitudinal axis lies.

[0416] In some implementations, the delivery tool or system defines an engagement portion at a distal end of a shaft. In some implementations, the engagement portion includes a first jaw and a second jaw opposite the first jaw. In some implementations, at least one of the jaws defines a shaft coupling configured to engage a receiver coupling. In some implementations, the jaws are biased to pivot away from each other and away from the midplane.

[0417] In some implementations, the first rocker is secured to the first jaw such that pivoting the first jaw away from the mid-plane moves at least a portion of the first rocker toward the mid-plane, and in some implementations, the second rocker is secured to the second jaw such that pivoting the second jaw away from the mid-plane moves at least a portion of the second rocker toward the mid-plane.

[0418] In some implementations, the anchor is dimensioned such that (i) the engagement portion engages with the anchor receiver via engagement between the shaft coupling and the receiver coupling, and (ii) while the anchor is disposed between the first jaw and the second jaw, the anchor maintains engagement of the engagement portion with the anchor receiver by maintaining engagement between the shaft coupling and the receiver coupling by impeding movement toward the midplane of the first rocker portion and the second rocker portion.

[0419] In some implementations, removal of the anchor from within the engagement portion disengages the delivery tool from the anchor receiver.

[0420] In some implementations, the first jaw is configured to pivot away from the midplane in a first direction and the second jaw is configured to pivot away from the midplane in a second, opposite direction such that the first rocker applies a force to the anchor in the first direction and the second rocker applies a force to the anchor in the second direction while the anchor maintains engagement of the engagement portion with the anchor receiver.

[0421] In some implementations, at least one of the rockers penetrates the midplane while the engagement portions are closed.

[0422] In some implementations, the first rocker extends sufficiently far about the central axis to circumferentially coincide with at least a portion of the second jaw while the engagement portion is closed.

[0423] In some implementations, a gap is defined between the first jaw and the second jaw while the engagement portion is closed, and the midplane passes along the gap.

[0424] In some implementations, the first locker is configured to pass through the second locker.

[0425] In some implementations, each rocker is shaped as an arc extending partway around the central longitudinal axis.

[0426] In some implementations, the shaft coupling is dimensioned to engage the receiver coupling by receiving the receiver coupling therein.

[0427] In some implementations, each of the first and second shaft couplings is shaped to define an opening.

[0428] In some implementations, each of the first and second receiver couplings defines a protrusion extending laterally from a corresponding one of the first and second anchor receivers.

[0429] According to some implementations, the system and / or device (which may be used, for example, in a live subject or a simulated heart) includes an anchor, an implant including an anchor receiver, and a delivery tool / system. In some implementations, the delivery tool or system includes a shaft having an engagement portion at a distal end of the shaft.

[0430] In some implementations, the engagement portion engages / engageable with the anchor receiver and the anchor is disposed / disposed in the engagement portion.

[0431] In some implementations, the delivery tool or system includes a driver configured to secure the implant to the cardiac tissue by engaging the anchor and using the anchor to secure the anchor receiver to the cardiac tissue.

[0432] In some implementations, the engagement portion is biased toward disengagement from the anchor receiver. In some implementations, an anchor is disposed on the engagement portion and prevents the engagement portion from disengaging from the anchor receiver.

[0433] In some implementations, removal of the anchor from within the engagement portion disengages the delivery tool from the anchor receiver.

[0434] According to some implementations, the system and / or device (which may be used, for example, in a living subject or in simulated cardiac tissue) includes an anchor, an implant, and a delivery tool / system. In some implementations, the implant may include an anchor receiver configured to receive the anchor and a lance that may be attached to the anchor receiver and / or configured to stabilize the implant relative to the tissue.

[0435] In some implementations, the delivery tool includes a shaft configured to position the implant at a site within the heart via engagement with the root of the wing (e.g., with the anchor receiver of the root of the wing) and / or to secure the root to tissue at the site by driving a lance into the tissue and / or reorienting within the tissue. For example, the lance can be engaged with the tissue in a manner that stabilizes the implant relative to the tissue.

[0436] In some implementations, engagement between the shaft and the root maintains the lance at a first angle.

[0437] In some implementations, the lance is made of a shape memory material.

[0438] In some implementations, the lance is a first of a plurality of lances attached to the root and configured to stabilize the implant relative to the tissue.

[0439] In some implementations, the implant further includes an anchor receiver at the root configured to receive the anchor.

[0440] In some implementations, (i) the system further includes an anchor, and (ii) the delivery tool further includes a driver configured to secure the root to tissue at the site by using the anchor to secure the anchor receiver to tissue at the site.

[0441] In some implementations, the driver is configured to use the anchor to secure the anchor receiver to tissue at the site while the lance remains disposed within the tissue at the site.

[0442] In some implementations, engagement between the shaft and the root maintains the lance at a first angle.

[0443] In some implementations, the lance is biased toward a rest position in which the lance is at a second angle relative to the root, the second angle being different from the first angle, and the bias is such that the lance moves toward the rest position in response to disengagement of the shaft from the root.

[0444] In some implementations, the anchor receiver has a contact surface that defines a receiver plane, and in a rest position, the lance is generally parallel to the receiver plane.

[0445] In some implementations, at a first angle, the lance projects away from the receiver plane.

[0446] In some implementations, in the rest position, the lance is surrounded by the anchor receiver.

[0447] According to some implementations, the system and / or device (which may be used with a heart, e.g., a valve of a live subject or a simulated heart) includes an implant, a first anchor, a second anchor, and / or a delivery tool / delivery system. In some implementations, the implant may include a first anchor receiver defining a first opening and a first interface connected to the first anchor receiver. In some implementations, the implant may include a second anchor receiver defining a second opening and a second interface connected to the second anchor receiver.

[0448] In some implementations, the first anchor can have a first head and a first tissue-engaging element, hi some implementations, the second anchor can have a second head and a second tissue-engaging element.

[0449] In some implementations, the delivery tool or delivery system may include a connector having a distal end that is (i) connected to the first and second interfaces in a manner that can maintain the first and second anchor receivers stacked with the first opening aligned with the second opening, and (ii) disconnectable from the first interface while remaining connected to the second interface in a manner that can facilitate movement of the second anchor receiver relative to the first anchor receiver.

[0450] In some implementations, the delivery tool or system may include at least one driver configured to secure the first anchor receiver to a first tissue site of the heart. In some implementations, the at least one driver may be configured to secure the first anchor receiver to the first tissue site of the heart by advancing the first anchor through the second opening and / or by driving the first tissue engaging element through the first opening and into the first tissue site. In some implementations, the second anchor receiver may then be secured to the second tissue site of the heart by advancing the second tissue engaging element through the second opening and into the second tissue site.

[0451] In some implementations, the second opening is wider than the first opening.

[0452] In some implementations, the second opening is wider than the first head.

[0453] In some implementations, the second opening is narrower than the second head.

[0454] In some implementations, the second head is wider than the first head.

[0455] In some implementations, the first head is sized to be intercepted by the first opening.

[0456] In some implementations, the second head is dimensioned to be intercepted by the second opening.

[0457] In some implementations, (i) the implant includes a third anchor receiver defining a third opening, and (ii) the system / device includes a third anchor having a third head and a third tissue engaging element.

[0458] In some implementations, the at least one driver is configured to secure the first anchor receiver to a first tissue site in the heart by (i) advancing the first anchor through the third opening and the second opening, and (ii) driving the first tissue engaging element through the first opening and to the first tissue site.

[0459] In some implementations, the at least one driver is configured to secure the third anchor receiver to a third tissue site in the heart by advancing the third tissue engaging element through the third opening and to the third tissue site after securing the second anchor receiver to the second tissue site.

[0460] In some implementations, (i) the delivery tool includes a catheter and a shaft extending through the catheter parallel to the connector, (ii) the shaft is coupled to the connector such that a connection between the connectors to the first and second interfaces maintains a distal opening of the shaft aligned with and facing the first and second openings of the stacked first and second anchor receivers, and (iii) at least one driver is configured to advance each of the first and second anchors through the shaft.

[0461] According to some implementations, the method (which may be used with a valve of a heart, e.g., a live subject or a simulated heart) includes advancing, within a catheter, an implant including a first anchor receiver, a second anchor receiver, and / or flexible wings coupled to the anchor receiver into a chamber. In some implementations, the wings may have a contact surface and an opposing surface opposing the contact surface.

[0462] In some implementations, the method can include advancing a first shaft and a second shaft parallel to one another through the catheter, with each of the shafts engaging a corresponding one of the anchor receivers.

[0463] The valve of the heart may have a first leaflet and an opposing leaflet (eg, a second leaflet), and / or the heart may have a chamber upstream of the valve.

[0464] In some implementations, the method may include using the shaft to deploy the implant out of the catheter within the chamber such that the wings extend away from the first and / or second anchor receivers. In some implementations, the method may then include using the shaft to position the implant in a position where the first anchor receiver is at a first location of the heart and the second anchor receiver is at a second location of the heart, with the wings extending over the first leaflet towards the opposing leaflet and / or the contact surface facing the first leaflet.

[0465] In some implementations, the method may then include fixing the implant at the first location and the second location by fixing the first anchor receiver and / or the second anchor receiver, respectively, to tissue of the heart.

[0466] In some implementations, the method further includes sterilizing the catheter. In some implementations, the method further includes sterilizing the implant. In some implementations, the method further includes sterilizing the first and second shafts.

[0467] In some implementations, the method further includes adjusting a distance between the first anchor receiver and the second anchor receiver within the heart by moving the first shaft relative to the second shaft.

[0468] According to some implementations, the method (which may be used with a valve of a heart, e.g., a live subject or a simulated heart) includes advancing, within a catheter, an implant including a first anchor receiver, a second anchor receiver, and / or flexible wings coupled to the anchor receiver into a chamber. In some implementations, the wings may have a contact surface and an opposing surface opposing the contact surface.

[0469] In some implementations, the method can include advancing a first shaft and a second shaft parallel to one another through the catheter, with each of the shafts engaging a corresponding one of the anchor receivers.

[0470] The valve may have a first leaflet and an opposing leaflet (eg, a second leaflet), and / or the heart may have a chamber upstream of the valve.

[0471] In some implementations, the method may include using the shaft to deploy the implant out of the catheter within the chamber such that the wings extend away from the first and / or second anchor receivers. In some implementations, the method may then include using the shaft to position the implant in a position where the first anchor receiver is at a first location of the heart and the second anchor receiver is at a second location of the heart, with the wings extending over the first leaflet towards the opposing leaflet and / or the contact surface facing the first leaflet.

[0472] In some implementations, the method may then include fixing the implant at the first location and the second location by fixing the first anchor receiver and / or the second anchor receiver, respectively, to tissue of the heart.

[0473] According to some implementations, the system and / or device (which may be used in a heart, e.g., a valve of a live subject or a simulated heart) includes an implant. The implant may include flexible wings, anchor receivers, and / or attachment elements, among other components. The flexible wings may have a root portion and / or a tip portion and may define a first (e.g., contact) surface and a second surface opposite the first surface.

[0474] The valve may have an annulus, a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0475] In some implementations, the anchor receiver may be coupled to a root portion of the wing and configured to receive the anchor and / or configured to secure by the anchor in a manner such that the wing extends away from the anchor receiver and over the first leaflet toward the opposing leaflet with a first surface facing the first leaflet and a second surface facing the chamber. The attachment element may be configured to attach to a labial edge of the first leaflet and / or may be positioned at a tip portion.

[0476] In some implementations, the attachment element is pivotally coupled to the wing.

[0477] In some implementations, the attachment element is flexible.

[0478] In some implementations, the attachment element is an anchor.

[0479] In some implementations, the attachment element is a clip.

[0480] In some implementations, the attachment elements are staples.

[0481] In some implementations, the attachment element is a pin.

[0482] In some implementations, the attachment element is configured to be sewn to the lip edge of the opposing leaflet.

[0483] In some implementations, the wing includes a braided mesh disposed over a flexible frame.

[0484] In some implementations, the wings are defined by a braided mesh.

[0485] In some implementations, the wing is configured to guide the first leaflet into coaptation with the opposing leaflet.

[0486] In some implementations, the wing includes a polymer frame.

[0487] In some implementations, the wing includes a metal frame.

[0488] In some implementations, the implant further includes at least one lance attached to the anchor receiver and configured to stabilize the implant relative to tissue of the heart.

[0489] In some implementations, the implant further includes a mounting indicator configured to indicate engagement between the anchor receiver and cardiac tissue.

[0490] In some implementations, the implant further includes a plurality of barbs extending from the first surface.

[0491] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0492] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0493] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0494] In some implementations, the system / device is for further use with a distal anchor, where (i) the anchor receiver is a root anchor receiver, (ii) the anchor is a root anchor, and (iii) the attachment element is a distal anchor receiver configured to receive the distal anchor and secured to the opposing leaflet by the distal anchor.

[0495] In some implementations, the root anchor receiver is a first root anchor receiver and the implant further includes a second root anchor receiver.

[0496] In some implementations, the flexibility of the wings facilitates intracardiac change of orientation between the second root anchor receiver and the first root anchor receiver.

[0497] In some implementations, the system / apparatus further includes a distal anchor.

[0498] In some implementations, the attachment element includes a jaw.

[0499] In some implementations, the attachment element is configured to be attached to the lip edge of the opposing leaflet by pinching the lip edge of the opposing leaflet against the tip portion.

[0500] In some implementations, the attachment element further includes a leaflet anchor coupled to the jaw and configured to be driven through the opposing leaflet, thereby securing the attachment element to the opposing leaflet.

[0501] In some implementations, the jaw is a first jaw and the attachment element further includes a second jaw, the first and second jaws configured to securely attach the lip edges of the opposing leaflets by clamping the lip edges of the opposing leaflets between the first jaw and the second jaw.

[0502] In some implementations, the first jaw is biased relative to the wing to move toward the second jaw.

[0503] In some implementations, the second jaw is biased relative to the wing to move toward the first jaw.

[0504] In some implementations, the second jaw is pivotally fixed relative to the first jaw such that the second jaw is moveable relative to the first jaw.

[0505] In some implementations, the implant has a delivery configuration in which the attachment element is adjacent the second surface.

[0506] In some implementations, the implant has a deployed configuration in which the wings extend away from the anchor receiver and the attachment elements extend away from the wings.

[0507] In some implementations, the attachment element extends away from the tip portion.

[0508] In some implementations, the attachment element is coupled to the wing at an oblique angle relative to the second surface.

[0509] In some implementations, the attachment element is coupled to the wing at an acute angle relative to the second surface.

[0510] In some implementations, the attachment element is coupled to the wing at an obtuse angle relative to the second surface.

[0511] In some implementations, the attachment element is coupled to the wing at a right angle to the second surface.

[0512] In some implementations, the system / apparatus further includes an anchor and a delivery tool.

[0513] In some implementations, the delivery tool includes (i) a catheter transluminally advanceable into the chamber and configured to receive the implant, and (ii) a shaft that engages with the anchor receiver.

[0514] In some implementations, the shaft is configured, through engagement with the anchor receiver, to (i) deploy the implant out of the catheter within the chamber such that the wings extend away from the anchor receiver and the attachment elements extend away from the wings, and (ii) position the implant at a location within the heart such that the anchor receiver is at a site with the wings extending over a first leaflet toward the opposing leaflet and the first surface facing the first leaflet.

[0515] In some implementations, the delivery tool includes a driver configured to engage the anchor and secure the implant in place by using the anchor to secure the anchor receiver to the tissue of the heart.

[0516] In some implementations, the delivery tool is configured to attach the attachment element to the lip edge of the opposing leaflet.

[0517] In some implementations, the shaft is configured to position the implant in a position such that the attachment elements are at the labial edge regions of the opposing leaflets.

[0518] In some implementations, the delivery tool further includes a tip driver configured to position the attachment element at the lip edge region of the opposing leaflet.

[0519] In some implementations, the tip driver is configured to attach the attachment element to the opposing leaflet at a lip edge region of the opposing leaflet.

[0520] In some implementations, the wing further includes a frame and a sheet disposed over the frame.

[0521] In some implementations, the sheet defines a plurality of holes therethrough, the holes being configured to facilitate blood flow through the wing.

[0522] In some implementations, the wing further includes a flexible frame that defines an adjustment node, the adjustment node being connected to an adjustment element that extends from the adjustment node to another portion of the implant.

[0523] In some implementations, the adjustment element is configured to facilitate intracardiac variation of the distance between the adjustment node and other portions of the implant via the application of a force by the adjustment element on the frame.

[0524] According to some implementations, the system and / or device (which may be used with a heart, e.g., a valve in a live subject or a simulated heart) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant may include flexible wings, an anchor receiver, and / or an attachment element, among other components.

[0525] In some implementations, the flexible wing may have a root portion and / or a tip portion and may define a first (eg, contact) surface and a second surface opposite the first surface.

[0526] In some implementations, the anchor receiver may be coupled to the root portion of the wing and may be configured to receive the anchor and / or be configured to be secured by the anchor.

[0527] The valve may have an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet, and / or the heart may have a chamber upstream of the valve.

[0528] The attachment element can be configured to attach to the labial edge of the first leaflet and / or can be positioned at the tip portion. In some implementations, multiple anchor receivers and multiple anchors can be included.

[0529] In some implementations, the delivery tool includes a catheter, a shaft, and a driver, among other components. In some implementations, the catheter is transluminally advanceable into the chamber.

[0530] In some implementations, the shaft may be configured to engage with the anchor receiver and / or, via engagement with the anchor receiver, (i) deploy the implant out of the catheter and / or (ii) position the implant at a location where the anchor receiver may be at a site within the heart and / or where the wings may extend over the first leaflet towards the opposing leaflet and where the first surface (e.g., the contact surface) faces the first leaflet.

[0531] In some implementations, the driver can be configured to secure the implant in place by engaging the anchor and / or using the anchor to secure the anchor receiver to tissue of the heart.

[0532] In some implementations, the delivery tool can be configured to attach the attachment element to the lip edge of the opposing leaflet.

[0533] In some implementations, the implant has a delivery configuration in which the attachment element is adjacent the second surface.

[0534] In some implementations, the implant has a deployed configuration in which the wings extend away from the anchor receiver and the attachment elements extend away from the wings.

[0535] In some implementations, the anchor receiver is configured to be secured to the annulus in a manner such that the wings extend away from the anchor receiver and over the first leaflet toward the opposing leaflet, with the first surface facing the first leaflet and the second surface facing the chamber.

[0536] In some implementations, the shaft is configured to position the implant in a position such that the attachment elements are at the labial edge regions of the opposing leaflets.

[0537] In some implementations, the catheter is configured to accommodate the implant.

[0538] In some implementations, the delivery tool further includes a tip driver configured to position the attachment element at the lip edge region of the opposing leaflet.

[0539] In some implementations, the tip driver is configured to attach the attachment element to the opposing leaflet at a lip edge region of the opposing leaflet.

[0540] In some implementations, the system is for further use with a distal anchor, where (i) the anchor receiver is a root anchor receiver, (ii) the anchor is a root anchor, and (iii) the attachment element is a distal anchor receiver configured to receive the distal anchor and secured to the opposing leaflet by the distal anchor.

[0541] In some implementations, the root anchor is a first root anchor and the implant further includes a second root anchor.

[0542] According to some implementations, the method (which may be used with a valve of a heart, e.g., a live subject or a simulated heart, the heart having a chamber) includes advancing, within a catheter, an implant, which may include a shaft and an anchor receiver engaging a distal end of the shaft and a flexible wing coupled to the anchor receiver, into the chamber. In some implementations, the wing may have a contact surface and a second surface opposite the contact surface.

[0543] The valve may have an annulus, a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0544] In some implementations, the method includes using a shaft to deploy the implant out of the catheter and into the chamber.

[0545] In some implementations, the method includes using the shaft to position the implant at the site of the annulus, the wings extending over a first leaflet toward the opposing leaflet, and the contact surface facing the first leaflet.

[0546] In some implementations, the tip portion of the wing can be attached to the lip edge of the opposing leaflet and the anchor receiver can be secured to the site.

[0547] In some implementations, the method further includes sterilizing the catheter. In some implementations, the method further includes sterilizing the implant. In some implementations, the method further includes sterilizing the shaft.

[0548] In some implementations, attaching the tip portion to the lip of the opposing leaflet includes attaching the tip portion to the lip of the opposing leaflet prior to securing the anchor receiver.

[0549] In some implementations, attaching the tip portion to the lip of the opposing leaflet includes attaching the tip portion to the lip of the opposing leaflet after securing the anchor receiver.

[0550] In some implementations, (i) the chamber is an upstream chamber, (ii) the heart has a downstream chamber downstream of the valve, and (iii) positioning the implant at the location includes positioning the implant such that a tip portion is disposed within the downstream chamber.

[0551] In some implementations, positioning the implant at the location includes positioning the implant such that a tip portion is disposed downstream of a lip edge of the first leaflet.

[0552] In some implementations, the contact surface is concave, and positioning the implant at the location includes positioning the implant such that the concave contact surface contacts the first leaflet.

[0553] In some implementations, positioning the implant at the location includes positioning the implant such that the second surface contacts the opposing leaflet.

[0554] In some implementations, the valve is a mitral valve of the heart, the chamber is a left atrium of the heart, and advancing the implant into the chamber includes advancing the implant into the left atrium.

[0555] In some implementations, the valve is a tricuspid valve of the heart, the chamber is a right atrium of the heart, and advancing the implant into the chamber includes advancing the implant into the right atrium.

[0556] In some implementations, the valve is an aortic valve of the heart, the chamber is a left ventricle of the heart, and advancing the implant into the chamber includes advancing the implant into the left ventricle.

[0557] In some implementations, the valve is a pulmonary valve of the heart and the chamber is a right ventricle of the heart, and advancing the implant into the chamber includes advancing the implant into the right ventricle.

[0558] In some implementations, securing the anchor receiver to the heart tissue includes pinning the first leaflet to the heart tissue.

[0559] In some implementations, securing the anchor receiver at the site includes using a driver to drive the anchor into the cardiac tissue.

[0560] In some implementations, attaching the tip portion of the wing to the labial edge of the opposing leaflet includes attaching an attachment element of the implant to the labial edge.

[0561] In some implementations, deploying the implant includes deploying the implant within the chamber such that the wings extend away from the anchor receiver and the attachment elements extend away from the wings.

[0562] In some implementations, attaching the attachment element to the lip edge includes sandwiching the lip edge between a first jaw and a second jaw of the attachment element.

[0563] In some implementations, positioning the implant at the location includes deploying the wings completely out of the catheter before positioning the implant at the location.

[0564] In some implementations, positioning the implant at the location includes positioning the implant at the location after the implant is deployed completely out of the catheter.

[0565] In some implementations, (i) the location is a first location, (ii) the site is the first site, and (iii) the method further includes, after installing the implant at the first location, repositioning the implant to a second location in the heart, where the anchor receiver is at a second site, the wings extend over the first leaflet toward the opposing leaflet, and the contact surface faces the first leaflet, the second location being different from the first location, and the second site being different from the first site.

[0566] According to some implementations, the method (which may be used with a valve of a heart, e.g., a live subject or a simulated heart) includes advancing, within a catheter, an implant into a chamber, which may include a shaft and an anchor receiver that engages a distal end of the shaft and a flexible wing coupled to the anchor receiver. The wing may have a contact surface and a second surface opposite the contact surface.

[0567] The valve may have an annulus, a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0568] In some implementations, the method includes using a shaft to deploy the implant out of the catheter and into the chamber.

[0569] In some implementations, the method includes using the shaft to position the implant at the site of the annulus, the wings extending over a first leaflet toward the opposing leaflet, and the contact surface facing the first leaflet.

[0570] In some implementations, a tip portion of the wing can be attached to the labial edge of the first leaflet and the anchor receiver can be secured to the site.

[0571] In some implementations, the method further includes sterilizing the catheter. In some implementations, the method further includes sterilizing the implant. In some implementations, the method further includes sterilizing the shaft.

[0572] In some implementations, attaching the tip portion to the lip of the first leaflet includes attaching the tip portion to the lip of the first leaflet prior to securing the anchor receiver.

[0573] In some implementations, attaching the tip portion to the lip edge of the first leaflet includes attaching the tip portion to the lip edge of the first leaflet after securing the anchor receiver.

[0574] In some implementations, the attaching step includes attaching a tip portion of the wing to a labial edge of the first leaflet by actuating a clip attached to the tip portion of the wing.

[0575] In some implementations, the deploying step includes deploying the implant out of the catheter and into the chamber while the clip is in the occluded state.

[0576] In some implementations, the attaching step includes (i) opening the clip, (ii) positioning the wing such that the lip edge of the first leaflet is disposed between the clip and a contact surface of the wing while the clip remains open, and (iii) closing the clip while the lip edge of the first leaflet remains between the clip and a contact surface of the wing.

[0577] In some implementations, the implant includes a rod and a tether connecting the rod to the clip, and the method includes manipulating a delivery tool to slide the rod along the wing such that the tether pulls the clip open.

[0578] In some implementations, manipulating the delivery tool to slide the rod along the wing includes manipulating the delivery tool to slide the rod longitudinally such that the rod extends beyond the labial edge of the first leaflet.

[0579] In some implementations, manipulating the delivery tool to slide the rod along the wing includes manipulating the delivery tool to slide the rod longitudinally such that the rod extends beyond the tip portion of the wing.

[0580] In some implementations, (i) the chamber is an upstream chamber, (ii) the heart has a downstream chamber downstream of the valve, and (iii) positioning the implant at the location includes positioning the implant such that a tip portion is disposed within the downstream chamber.

[0581] In some implementations, positioning the implant at the location includes positioning the implant such that a tip portion is disposed downstream of a lip edge of the first leaflet.

[0582] In some implementations, the contact surface is concave, and positioning the implant at the location includes positioning the implant such that the concave contact surface contacts the first leaflet.

[0583] In some implementations, positioning the implant at the location includes positioning the implant such that the second surface contacts the opposing leaflet.

[0584] In some implementations, the valve is a mitral valve of the heart, the chamber is a left atrium of the heart, and advancing the implant into the chamber includes advancing the implant into the left atrium.

[0585] In some implementations, the valve is a tricuspid valve of the heart, the chamber is a right atrium of the heart, and advancing the implant into the chamber includes advancing the implant into the right atrium.

[0586] In some implementations, the valve is an aortic valve of the heart, the chamber is a left ventricle of the heart, and advancing the implant into the chamber includes advancing the implant into the left ventricle.

[0587] In some implementations, the valve is a pulmonary valve of the heart and the chamber is a right ventricle of the heart, and advancing the implant into the chamber includes advancing the implant into the right ventricle.

[0588] In some implementations, securing the anchor receiver to the heart tissue includes pinning the first leaflet to the heart tissue.

[0589] In some implementations, securing the anchor receiver at the site includes using a driver to drive the anchor into the cardiac tissue.

[0590] In some implementations, attaching the tip portion of the wing to the labial edge of the first leaflet includes attaching an attachment element of the implant to the labial edge.

[0591] In some implementations, attaching the attachment element to the lip edge includes sandwiching the lip edge between the attachment element and the contact surface.

[0592] In some implementations, positioning the implant at the location includes deploying the wings completely out of the catheter before positioning the implant at the location.

[0593] In some implementations, positioning the implant at the location includes positioning the implant at the location after the implant is deployed completely out of the catheter.

[0594] In some implementations, (i) the location is a first location, and (ii) the site is the first site, and the method further includes, after installing the implant at the first location, repositioning the implant to a second location in the heart, where the anchor receiver is at a second site, the wings extend over the first leaflet toward the opposing leaflet, and the contact surface faces the first leaflet, the second location being different from the first location, and the second site being different from the first site.

[0595] In some implementations, the second location is a second location on an annulus of the valve.

[0596] According to some implementations, the method (which may be used with a valve of a heart, e.g., a live subject or a simulated heart, where the heart may have a chamber) includes advancing, within a catheter, an implant, which may include a shaft and an anchor receiver that engages with a distal end of the shaft, and flexible wings coupled to the anchor receiver, into the chamber.

[0597] In some implementations, the airfoil can have a contact surface and a second surface opposite the contact surface.

[0598] The valve may have an annulus, a first leaflet and an opposing leaflet, and / or the heart may have a chamber upstream of the valve.

[0599] In some implementations, the method can include using a shaft to deploy the implant out of the catheter and into the chamber.

[0600] In some implementations, the method can include using the shaft to position the implant at a site on the annulus with the anchor receiver at the site, the wing extending over the first leaflet toward the opposing leaflet, and the contact surface facing the first leaflet. A tip portion of the wing can be attached to the labrum of the first leaflet, and the anchor receiver can be secured to the site.

[0601] According to some implementations, the system and / or device (which may be used in the heart, e.g., in valves of a live subject or a simulated heart) includes an anchor and an implant, which may include flexible wings, an anchor receiver, and / or attachment elements, among other components.

[0602] In some implementations, the flexible wing may have a root portion and / or a tip portion and may define a first (e.g., contacting) surface and a second surface opposite the first surface, and a number of barbs extending from the contact surface.

[0603] In some implementations, the anchor receiver may be coupled to the root portion of the wing and may be configured to receive the anchor and / or be configured to be secured by the anchor.

[0604] In some implementations, the attachment element may be configured to be attached to the labial edge of the first leaflet and / or may be positioned at a tip portion.

[0605] In some implementations, multiple anchor receivers and multiple anchors can be included.

[0606] The valve may have an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet, and / or the heart may have a first chamber upstream of the valve and a second chamber downstream of the valve.

[0607] In some implementations, the delivery tool includes a catheter, a shaft, and a driver, among other components. In some implementations, the catheter is transluminally advanceable into the chamber.

[0608] In some implementations, the shaft may engage with the anchor receiver and / or may be configured to (i) deploy the implant out of the catheter and / or (ii) position the implant at a location where the anchor receiver may be at a site within the heart and / or where the wings may extend over the first leaflet towards the opposing leaflet with the first (e.g., contact) surface facing the first leaflet.

[0609] In some implementations, the driver can be configured to secure the implant in place by engaging the anchor and / or using the anchor to secure the anchor receiver to tissue of the heart.

[0610] In some implementations, the shaft is configured to position the implant in a manner that presses at least a portion of the barb into the first leaflet.

[0611] In some implementations, the barb is configured to progressively penetrate the first leaflet during the course of one or more cardiac cycles of the heart.

[0612] In some implementations, at least some of the barbs are sized to only partially penetrate the first leaflet.

[0613] In some implementations, at least a portion of the barb is sized to penetrate completely through the first leaflet.

[0614] According to some implementations, the system and / or device (which may be used with a heart, e.g., a valve in a live subject or a simulated heart) includes an anchor, an implant, and / or a delivery tool. In some implementations, the implant may include flexible wings, an anchor receiver, and / or an attachment element, among other components.

[0615] In some implementations, the flexible wing may have a root portion and / or a tip portion and may define a first (eg, contact) surface and a second surface opposite the first surface.

[0616] In some implementations, the anchor receiver may be coupled to the root portion of the wing and may be configured to receive the anchor and / or be configured to be secured by the anchor.

[0617] In some implementations, the attachment element may be configured to be attached to the labial edge of the first leaflet and / or may be positioned at a tip portion.

[0618] In some implementations, multiple anchor receivers and multiple anchors can be included.

[0619] The valve may have an annulus, a first leaflet, and an opposing leaflet opposite the first leaflet, and / or the heart may have a chamber upstream of the valve.

[0620] In some implementations, the delivery tool includes, among other components, a catheter, a shaft, and a driver. The catheter is transluminally advanceable into the chamber.

[0621] In some implementations, the shaft may engage with the anchor receiver and / or may be configured to (i) deploy the implant out of the catheter and / or (ii) position the implant at a location where the anchor receiver may be at a site within the heart and / or where the wings may extend over the first leaflet towards the opposing leaflet with the first (e.g., contact) surface facing the first leaflet.

[0622] In some implementations, the driver can be configured to secure the implant in place by engaging the anchor and / or using the anchor to secure the anchor receiver to tissue of the heart.

[0623] In some implementations, a fastening tool can be advanceable through the catheter and configured to fasten the wing to the first leaflet within the heart.

[0624] In some implementations, the fastening tool is configured to fasten the wing to the first leaflet in the heart by at least partially piercing a portion of the wing.

[0625] In some implementations, the fastening tool is configured to fasten the wing to the first leaflet in the heart by at least partially piercing a portion of the first leaflet.

[0626] In some implementations, the fastening tool is configured to fasten the wing to the first leaflet intracardially by delivering a fastener to the wing via the catheter.

[0627] In some implementations, the fastening tool is configured to intracardially fasten the wing to the first leaflet by delivering a pledget via the catheter to the wing and the first leaflet.

[0628] In some implementations, the fastening tool is configured to fasten the wing to the first leaflet within the heart by delivering staples to the wing and the first leaflet via the catheter.

[0629] In some implementations, the fastening tool is configured to intracardially fasten the wing to the first leaflet by delivering darts via the catheter to the wing and the first leaflet.

[0630] In some implementations, the fastening tool is configured to fasten the wing to the first leaflet intracardially by delivering a clip to the wing and the first leaflet via the catheter.

[0631] In some implementations, the fastening tool is configured to intracardially fasten the wing to the first leaflet by delivering a suture to the wing and the first leaflet via the catheter.

[0632] According to some implementations, the method (which may be used with a valve of a heart, e.g., of a living subject or a simulated heart, the valve having a valve annulus, a first leaflet, and an opposing leaflet, and the heart having a chamber upstream of the valve) includes determining that the implant is positioned such that flexible wings of the implant extend over the first leaflet, toward the opposing leaflet, and / or a contact surface of the wing faces the upstream surface of the first leaflet.

[0633] In some implementations, a fastening tool can be advanced transluminally into the chamber and used to fasten the wing to the first leaflet with the contact surface in contact with the upstream surface.

[0634] In some implementations, the method further includes sterilizing the fastening tool.

[0635] In some implementations, the method further includes sterilizing the implant.

[0636] In some implementations, the fastening step includes fastening the wing to the first leaflet by piercing the wing.

[0637] In some implementations, the fastening step includes fastening the wing to the first leaflet by piercing the first leaflet.

[0638] In some implementations, the fastening step includes fastening the wing to the first leaflet by delivering a fastener to the wing via the catheter.

[0639] In some implementations, the determining step includes determining that a root portion of the implant is secured to the annulus.

[0640] In some implementations, the wing has a root portion and a tip portion opposite the root portion, and the method further includes actuating the anchor to secure the root portion to the annulus.

[0641] In some implementations, the fastening step includes fastening the wing to the first leaflet by delivering a pledget via the catheter to the wing and the first leaflet.

[0642] In some implementations, the fastening step includes fastening the wing to the first leaflet by delivering staples via the catheter to the wing and the first leaflet.

[0643] In some implementations, the fastening step includes fastening the wing to the first leaflet by delivering a dart via the catheter to the wing and the first leaflet.

[0644] In some implementations, the fastening step includes fastening the wing to the first leaflet by delivering a clip via the catheter to the wing and the first leaflet.

[0645] In some implementations, the fastening step includes fastening the wing to the first leaflet by delivering a suture via the catheter to the wing and the first leaflet.

[0646] According to some implementations, the method (which may be used with a valve of a heart, e.g., of a living subject or a simulated heart, the valve having a valve annulus, a first leaflet, and an opposing leaflet, and the heart having a chamber upstream of the valve) includes determining that the implant is positioned such that flexible wings of the implant extend over the first leaflet, toward the opposing leaflet, and / or a contact surface of the wing faces the upstream surface of the first leaflet.

[0647] In some implementations, a fastening tool can be advanced transluminally into the chamber and used to fasten the wing to the first leaflet with the contact surface in contact with the upstream surface.

[0648] According to some implementations, the method (which may be used with a valve of a heart, e.g., of a living subject or a simulated heart, the valve having a valve annulus, a first leaflet, and an opposing leaflet, and the heart having a chamber upstream of the valve) includes determining that the implant is positioned such that flexible wings of the implant extend over the first leaflet, toward the opposing leaflet, and / or a contact surface of the wing faces the upstream surface of the first leaflet.

[0649] In some implementations, the rods that engage the wings can be manipulated in a manner that alters the structure of the implant.

[0650] In some implementations, the method further includes sterilizing the rod.

[0651] In some implementations, the method further includes sterilizing the implant.

[0652] In some implementations, the implant defines a frame, the frame providing mechanical support to the wing, and the manipulating step includes extending the rod by advancing the rod longitudinally relative to the frame.

[0653] In some implementations, the rod defines a leg or extension extending from a tip portion of the wing, and the manipulating step includes extending the rod such that contact between a contact portion of the leg and tissue of the second chamber restricts pivoting of the wing about the site of the annulus.

[0654] In some implementations, the extending step includes extending the rod such that a contact portion of the leg contacts a wall of the second chamber.

[0655] In some implementations, the extending step includes extending the rod such that a contact portion of the leg contacts the papillary muscle.

[0656] In some implementations, the manipulating step is performed after the positioning step.

[0657] In some implementations, the method further includes securing a root portion of the wing to a site at the annulus.

[0658] In some implementations, the fixing step is performed before the manipulating step.

[0659] In some implementations, the fixing step is performed after the manipulating step.

[0660] In some implementations, the manipulating step includes sliding a rod longitudinally along the wing in a manner that alters the structure of the implant.

[0661] In some implementations, the manipulating step includes extending the rod longitudinally beyond the tip portion of the wing in a manner that alters the structure of the implant.

[0662] In some implementations, (i) the implant includes a clip attached to a tip portion of the wing, (ii) the positioning step includes positioning the implant such that the tip portion of the wing faces a lip portion of the first leaflet, and (iii) the manipulating step includes manipulating the rod to transition the clip between an open configuration and a closed configuration.

[0663] In some implementations, the manipulating step includes manipulating the rod in a manner to articulate the clip between an open configuration and a closed configuration.

[0664] In some implementations, the implant further includes a tether connected to the clip, and the manipulating step includes manipulating the rod in a manner that transitions the clip between the open and closed configurations by changing an amount of tension in the tether.

[0665] In some implementations, the implant further includes a tether connected to the clip, and the manipulating step includes manipulating the rod in a manner that transitions the clip toward the open configuration by increasing tension on the tether.

[0666] In some implementations, the method further includes securing a root portion of the wing to a site at the annulus.

[0667] In some implementations, the fixing step is performed before the manipulating step.

[0668] In some implementations, the fixing step is performed after the manipulating step.

[0669] According to some implementations, the method (which may be used with a valve of a heart, e.g., a live subject or a simulated heart, the valve having a valve annulus, a first leaflet, and an opposing leaflet) includes determining that the implant is positioned such that flexible wings of the implant extend over the first leaflet toward the opposing leaflet and / or a contact surface of the wing faces an upstream surface of the first leaflet.

[0670] In some implementations, the rods that engage the wings can be manipulated in a manner that alters the structure of the implant.

[0671] Any of the methods listed in this Summary can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, a body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include a computerized or physical representation.

[0672] Any of the above systems, devices, instruments, etc. in this summary of the invention may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.), and the methods described herein may include (or in some additional methods consist of) sterilization of one or more of the systems, devices, instruments, etc. herein (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0673] The concepts herein will be more fully understood from the following detailed description of implementations thereof, taken in conjunction with the drawings. [Brief description of the drawings]

[0674] [Figure 1A] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 1B] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2A] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2B] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2C] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2D] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2E] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2F] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 2G] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Diagram 3]1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 4A] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 4B] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Diagram 5] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 6A] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 6B] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 6C] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 7] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 8] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 9] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 10] 1 is a schematic diagram of an implant including its aesthetic features according to some implementations. [Figure 11A] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 11B] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 11C] 1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 11D]1 is a schematic diagram of a system, including its aesthetic features, for use in a heart valve according to some implementations. [Figure 12A] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 12B] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 13A] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 13B] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 14] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 15A] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 15B] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 16A] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 16B] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 17A] 1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 17B] 1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 17C] 1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 17D]1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 18] 1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 19A] 1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 19B] 1 is a schematic diagram of an implant with a fit indicator including its aesthetic features according to some implementations. [Figure 20] 1 is a schematic diagram of a system, including its aesthetic features, for use in cardiac tissue according to some implementations. [Figure 21] 1 is a schematic diagram of a system, including its aesthetic features, for use in cardiac tissue according to some implementations. [Figure 22A] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 22B] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 22C] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 23A] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 23B] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 23C] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 23D] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 23E]1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 24A] 1 is a schematic diagram of an implant having wings, including their aesthetic features, indirectly secured to cardiac tissue, according to some implementations. [Figure 24B] 1 is a schematic diagram of an implant having wings, including their aesthetic features, indirectly secured to cardiac tissue, according to some implementations. [Figure 25A] 1 is a schematic diagram of an implant having wings, including their aesthetic features, indirectly secured to cardiac tissue, according to some implementations. [Figure 25B] 1 is a schematic diagram of an implant having wings, including their aesthetic features, indirectly secured to cardiac tissue, according to some implementations. [Figure 26A] 1 is a schematic diagram of a system for use with a heart valve, including its aesthetic features, according to some implementations. [Figure 26B] 1 is a schematic diagram of a system for use with a heart valve, including its aesthetic features, according to some implementations. [Figure 26C] 1 is a schematic diagram of a system for use with a heart valve, including its aesthetic features, according to some implementations. [Figure 26D] 1 is a schematic diagram of a system for use with a heart valve, including its aesthetic features, according to some implementations. [Figure 26E] 1 is a schematic diagram of a system for use with a heart valve, including its aesthetic features, according to some implementations. [Figure 26F] 1 is a schematic diagram of a system for use with a heart valve, including its aesthetic features, according to some implementations. [Figure 27A] FIG. 1 is a schematic diagram of a system, including its aesthetic features, for use with an implant, according to some implementations. [Figure 27B] FIG. 1 is a schematic diagram of a system, including its aesthetic features, for use with an implant, according to some implementations. [Figure 27C]FIG. 1 is a schematic diagram of a system, including its aesthetic features, for use with an implant, according to some implementations. [Figure 28A] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Figure 28B] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Figure 29A] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Figure 29B] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Figure 30A] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Figure 30B] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Figure 30C] 1 is a schematic diagram of a system, including its aesthetic features, for use within the heart, according to some implementations. [Diagram 31] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Diagram 32] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Diagram 33] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Diagram 34] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Diagram 35] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Diagram 36] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 37] 1 is a schematic diagram of an implant, including its aesthetic features, for use in a heart valve, according to some implementations. [Figure 38A] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 38B] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 38C] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 39A] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 39B] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 39C] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 39D] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 39E] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 40A] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 40B] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 41A] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Figure 41B] 1A-1C are schematic diagrams of various implants including their aesthetic features according to some implementations. [Diagram 42] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Diagram 43] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Diagram 44] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Diagram 45] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Diagram 46] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Figure 47] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Figure 48] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Figure 49A] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. [Figure 49B] 1 is a schematic diagram of an implant including at least one leg or extension, including its aesthetic features, according to some implementations. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0675] Systems, devices, apparatus, methods, etc. for reducing regurgitation in a heart valve are described herein. In some implementations, the systems, devices, apparatus, methods, etc. include an implant / device secured to an annulus of a valve. The systems, devices, apparatus, methods, etc. may be configured to provide contact pressure to a leaflet region, support the leaflet region, and / or induce movement of a leaflet region experiencing flail, prolapse, stiffness, etc. Various examples of methods for delivering and implanting such implants and devices into a valve are described.

[0676] The disclosed systems, devices, apparatus, 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 as well as in various combinations and subcombinations with one another. The disclosed systems, devices, apparatus, methods, etc. are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed systems, devices, apparatus, methods, etc. require that any one or more particular advantages be present or problems be solved. Furthermore, the techniques, operations, steps, etc. described or proposed herein can be performed on living subjects (e.g., humans, other animals, etc.) or can be performed on non-living subjects (e.g., simulations such as cadavers, cadaver hearts, simulators, anthropomorphic phantoms, etc.). When performed in a simulation, body parts, e.g., hearts, tissues, valves, etc., can optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.) and can include computerized and / or physical representations of body parts, tissues, etc.

[0677] Various implementations of prosthetic implant systems, devices, embodiments, etc. are disclosed herein, and any combination of the described features, components, and options may be made unless specifically excluded. For example, the various descriptions of anchors may be used with any suitable prosthetic device and / or delivered and implanted by any suitable method, even if a particular combination is not explicitly described. Similarly, different structures and features of devices and systems may be mixed and matched, such as by combining any implant device types / features, attachment types / features, repair sites, etc., even if not explicitly disclosed. In summary, individual components of the disclosed systems may be combined unless otherwise mutually exclusive or physically impossible.

[0678] Although some operations of the disclosed methods are described in a particular sequential order for convenience of presentation, it should be understood that the described method encompasses rearrangements, unless a particular order is required by specific language described below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various aspects in which the disclosed systems, devices, apparatus, methods, etc. may be used in combination with other systems, devices, apparatus, methods, etc.

[0679] 1A-B, 2A-G, 3, 4A-B, and 5-9, which are schematic diagrams of an exemplary system 20 according to some implementations. In some implementations, the system 20 may be configured for use with a valve of a heart 4 (e.g., a living subject and / or a simulated heart). In some figures, the system 20 is shown for use with a mitral valve 10 of a heart, where the heart chamber upstream of the mitral valve is the left atrium 6 and the heart chamber downstream of the mitral valve is the left ventricle 8. However, the system 20 may also be used, mutatis mutandis, with other atrioventricular valves (tricuspid valves) from which another atrium (right atrium) is upstream and another ventricle (right ventricle) is downstream. The system 20 may also be used with a vena cava valve or a pulmonary valve from which the upstream heart chamber is a ventricle (left ventricle and right ventricle, respectively).

[0680] In some implementations, the system 20 includes a catheter 40, a delivery tool 50, and an implant 100 that may function as a repair device, a leaflet repair device, a prolapse / flaccid repair device, a contact pressure device, a support device, or the like.

[0681] In some implementations, the implant 100 includes an interface 110 and a flexible wing 120 coupled to the interface. The wing 120 can have a contact surface 122 and an opposing surface 123 opposite the contact surface.

[0682] In some implementations, the implant 100 is secured using anchors, and such anchors may be provided. The implant may be secured in a variety of manners. In some implementations, the implant 100 may be secured to the annulus of the valve at the site of the implant, for example, as shown in FIGS. 2F-G. The implant may be configured to guide the leaflets, for example, by applying contact pressure or additional support to the leaflets (e.g., to a portion of the leaflets).

[0683] 2G and 5, the implant may be implanted into a native valve (e.g., in a mitral, tricuspid, or the like) such that the contact surface 122 is located on the upstream surface (e.g., on the atrial side) of the native leaflet (shown as the posterior leaflet) at the site of flutter, prolapse, stiffness, and / or other leaflet abnormality. In some implementations, the contact surface may provide contact pressure and / or support to flatten and / or reshape the protuberance, protrusion, flutter, etc., thereby directing the portion of the leaflet experiencing flutter, prolapse, stiffness, etc., to reduce regurgitant blood flow.

[0684] In some implementations, once the implant 100 is implanted, two (e.g., both) of the leaflets of the valve may abut against a portion of the wing 120 (i.e., one leaflet abuts against the contact surface 122 and the other leaflet abuts against the opposing surface 123, thereby sandwiching a portion of the wing between the leaflets). This portion of the wing may thus be considered to be the abutting portion of the wing.

[0685] In some implementations, the wings are configured to extend beyond the lower edge of the native leaflet (eg, into the ventricle 8).

[0686] In some implementations, the implant 100 has a covering that spans the contact surface and can help provide guidance, contact pressure and / or support for flail, prolapse, stiffness, leaflet abnormalities, etc. In some implementations, the covering is a mesh sheet. In some implementations, the covering is one or more of a woven sheet, a polymer sheet, a pericardial sheet, etc. The contact surface and / or covering can be configured to allow blood and plasma to flow therethrough such that pressure from the blood does not break, deflect, or dislodge the implant. A mesh covering can be particularly useful for allowing blood and plasma to flow therethrough while still providing functionality of the implant.

[0687] In some implementations (not illustrated in this application), the implant may include an optional support (e.g., a counterforce support, an atrial support, etc.), which may be similar in structure and / or function to one or more of those described in Cau et al., PCT International Publication WO 2022 / 006087, incorporated herein by reference. In some implementations, the support may be in the general shape of a flower or clover, for example, having multiple petals. The support may be configured to press or abut against the wall of the heart (e.g., the wall of the atrium) or against the annulus of the valve to help orient and / or maintain the position of the implant, which may help the implant maintain contact pressure and / or support on the native leaflets. The support may also be configured to help prevent the contact surface and / or a covering thereon from fluttering or otherwise moving back into or toward the atrium in an undesirable manner. In some implementations, as shown, the support includes (e.g., consists essentially of) a wire loop.

[0688] In some implementations, the implant 100 further includes an anchor 30 that secures the implant 100 to the valve annulus. In some implementations, the anchor 30 is a threaded anchor having a helical tissue-engaging element 34 and a head 32 (e.g., as shown in FIG. 1A).

[0689] In some implementations, the delivery tool 50 may include a shaft 60 and a driver 70. The shaft 60 is configured to engage the interface 110 and, through this engagement, deploy and position the implant 100, for example, as described in more detail below. This engagement may be achieved by the shaft 60 having a shaft head 62 with one or more couplings 64, such as latches or arms, that engage one or more couplings 114 (e.g., recesses, slots, notches, or receptacles) of the interface 110.

[0690] In some implementations, the driver 70 is configured to secure the implant 100 to cardiac tissue by engaging the anchor 30 (e.g., its head 32) and using the anchor to secure the interface 110 to the tissue. In some implementations, the driver 70 includes a flexible drive shaft 74 and a drive head 72 at a distal end of the driver, the drive head adapted to engage the head 32 of the anchor.

[0691] In some implementations, as shown, the wing 120 comprises a frame (e.g., a wire frame) 124 and a sheet 126 that spans the frame. In some implementations, the wing 120 has a root 130 that is coupled to the interface 110 and a tip 132 at the opposite end of the wing from the root. The tip 132 represents the free end of the wing 120.

[0692] In some implementations, the frame 124 is attached to the interface 110. For example, as shown, at the root 130, the frame 124 may define a ring 128 that fits around the interface 110. The wing 120 may define two lateral sides 134 (e.g., a first lateral side 134a and a second lateral side 134b) that extend from the root to the tip.

[0693] In some implementations, as shown, the frame 124 defines two loops 136 (e.g., a first loop 136a and a second loop 136b) that extend parallel to one another from the root 130, for example, all the way to the tip 132. Note that, as shown, the loops 136 can be individual loops rather than cells of a cellular or lattice structure. For example, the loops 136 can be disconnected from one another and / or any other metal components of the implant 100, except for the root 130 (e.g., at the ring 128 and / or interface 110). Additionally, each of the loops 136 can be configured to enclose a space 137 that is substantially free of frame components. In some implementations, as shown, each of the loops 136 is substantially teardrop shaped.

[0694] In some implementations in which the frame 124 defines a loop 136, the frame 124 defines an elongated space 138 between the two loops. The space 138 may extend from the root 130 towards the tip 132, such as all the way to the tip (e.g., such that the frame 124 does not bridge the two loops at the tip). In some implementations, as shown, the space 138 extends along a plane of reflective symmetry of the wing 120.

[0695] In some implementations in which the frame 124 defines loops 136, the sheet 126 can be configured to extend over and between the loops, for example, across both the loops and the spaces 138.

[0696] In some implementations, the sheet 126 has a plurality of holes 140 therethrough. In some implementations, the holes 140 are checkered relative to one another. In some implementations, the holes 140 are oval (e.g., circular). In some implementations, as shown, the holes 140 are polygonal. For example, as shown, the holes 140 can be hexagonal. As shown, some of the holes 140 can be disposed over the spaces 137. Alternatively or additionally, some of the holes 140 can be disposed over the spaces 138. In some implementations, as shown, the size and number of holes 140 are such that the holes collectively cover more than 20 percent and / or less than 80 percent of the wing 120 (e.g., by area), e.g., between 20 and 80 percent of the wing, e.g., between 20 and 70 percent of the wing (e.g., between 30 and 70 percent of the wing, e.g., between 30 and 60 percent of the wing or between 40 and 70 percent of the wing), or between 30 and 80 percent of the wing (e.g., between 40 and 80 percent of the wing).

[0697] In some implementations, the wings 120 are curved such that the contact surface 122 is concave. That is, the curvature of the wings 120 is such that in a cross section of the implant 100 through the interface 110 and the wings, the contact surface 122 is concave. As shown, this cross section can be in a plane of reflection symmetry of the implant between the loops 136, for example, along the space 138. FIG. 1A shows the location of the cross section using indicator A, and FIG. 1B is a schematic diagram of this cross section. FIG. 1B shows the implant 100 with the anchor 30 in place, for example, as if the implant had been implanted.

[0698] In some implementations, as shown, the curvature of the wing 120 increases with distance from the interface 110, e.g., such that the curvature is greatest at the tip 132. For example, as shown in FIG. 1B , at the tip 132, after fixation of the implant 100 by the anchor 30, the tangent ax2 of the curvature of the wing 120 can be less than 60 degrees (e.g., less than 45 degrees, such as less than 35 degrees) relative to the anchor axis ax1 of the anchor 30. This angle between the tangent ax2 and the axis ax1 can be determined at least in part by the geometry of the interface 110 and / or the anchor receiver 150 at the interface (described below), e.g., with respect to the geometry of the anchor 30.

[0699] In some implementations, as described in more detail below, the angular orientation of the wings 120 relative to the interface 110 and / or anchor receiver 150 is such that the interface is positioned relative to tissue of the atrium of the heart (e.g., relative to the annulus of the atrioventricular valve of the heart or relative to the wall of the atrium) such that the tip 132 is positioned within the ventricle downstream of the atrium and atrioventricular valve.

[0700] 2A-G show at least some steps in an exemplary implantation of an implant 100 according to some implementations. The implant 100 is advanced within a catheter 40 into a heart chamber (e.g., left atrium 6) upstream of a heart valve (e.g., mitral valve 10) to be treated (FIG. 2A). For example, the catheter 40 may be advanced into the chamber prior to advancing the implant 100 through the catheter, or the catheter may be advanced into the chamber with the implant already positioned therein. The mitral valve 10 has a first leaflet (e.g., posterior leaflet) 12 and an opposing leaflet (e.g., anterior leaflet) 14. In the illustrated example, a portion 16 of the posterior leaflet 12 is experiencing flutter. It is noted that the system 20 may be used mutatis mutandis to treat flutter of the anterior leaflet 14 as well.

[0701] In the embodiment shown, catheter 40 is advanced transluminally (e.g., transfemorally) into the heart chamber; however, meridian (e.g., surgical) approaches are also within the scope of this disclosure. Similarly, although a transfemoral approach is shown, the scope of this disclosure includes advancement via the superior vena cava. Note that while the catheter is shown taking a septal approach from right atrium 5 to left atrium 6, the actual septum is not shown, as it is behind aorta 7. A portion of catheter 40 is shown in phantom to show that it is behind aorta 7 (FIGS. 2A-B).

[0702] As shown, in some implementations, advancement of the implant 100 through the catheter 40 is performed while the shaft 60 (e.g., its head 62) is engaged with the implant's interface 110. In some implementations, the implant 100 is advanced through the catheter 40 while the wings 120 are constrained (e.g., compressed, folded, and / or rolled) within the catheter.

[0703] In some implementations, using the shaft 60, the implant 100 is deployed out of the catheter 40 within the atrium 6 such that the wings 120 extend away from the interface 110 (FIGS. 2B-C). In some implementations, the wings 120 expand upon deployment toward the shape described with reference to FIGS. 1A-B, for example, due to the elasticity and / or shape memory of the frame 124. In some implementations, as shown, the wings 120 (and optionally the entire implant 100) are fully deployed (i.e., exposed) from the catheter 40 before being positioned against tissue. Then, using the shaft 60, the implant 100 is positioned such that the wings 120 extend over the first leaflet 12 toward the opposing leaflet 14, with the contact surface 122 facing the first leaflet, when the interface 110 is positioned at the site 18 within the heart (FIG. 2D). In some implementations, as shown, the wing 120 extends over the first leaflet 12 such that the tip 132 is disposed beyond (e.g., downstream of) the lip of the first leaflet, e.g., with the opposing surface 123 facing the opposing leaflet 14, e.g., within the left ventricle 8. In some implementations, this is due at least in part to the geometry and dimensions of the implant 100 and / or the site 18. For example, as shown, the site 18 can be on the annulus of the valve being treated, e.g., at the root of the leaflet experiencing flutter. Thus, in the example shown, the wing 120 extends from the interface 110 of the site 18 on the mitral valve annulus 11 at the root of the posterior leaflet 12, over the posterior leaflet 12 toward the opposing leaflet 14, curving downstream between the leaflets 12 and 14 beyond the lip of the leaflet 12 such that the tip 132 is disposed within the ventricle 8.

[0704] The wings 120 may be positioned at various angles relative to the catheter shaft and / or the natural anatomy (e.g., the valve annulus and / or leaflets) during delivery. For example, the implant may be angled during delivery at 20-160 degrees relative to the axis of the distal portion of the catheter (and / or relative to the plane of the valve annulus), such as 30-150 degrees, 40-140 degrees, 50-130 degrees, 60-120 degrees, or 70-110 degrees.

[0705] In some implementations, the optimality of a given position of the implant 100 may be determined during the implantation procedure, e.g., prior to securing the implant to tissue. For example, optimality may be determined using blood pressure sensing and / or imaging techniques such as fluoroscopy and echocardiography. For example, a Doppler echocardiogram may be used to determine the degree to which regurgitation through the valve has been reduced.

[0706] To illustrate the advantages of the system 20, FIG. 2D shows the implant 100 initially suboptimally positioned, for example with the wings 120 positioned away from the flap 16. That is, the site 18 is the initial site 18a where the interface 110 is positioned. At this point, the implant 100 is not yet secured to the tissue, and the interface 110 can simply be moved to another site 18, for example, the second site 18b (FIG. 2E). For example, the interface 110 can simply be slid along the annulus 11. In some implementations, the interface can be lifted away from the tissue at the first location and then seated against the tissue at the second location. As shown, this repositioning can be performed without withdrawal (e.g., even partial withdrawal) of the implant 100 into the catheter 40. In the illustrated embodiment, this second position of the implant 100 is more preferable than the first position, for example, at the second site 18b, where the wings 120 are positioned above the flap 16, and valve regurgitation is minimized or eliminated.

[0707] Upon determining that the implant 100 is suitably (e.g., optimally) positioned, the implant is secured in place, for example, by securing the interface 110 to the heart tissue at site 18 (FIG. 2F). This may be accomplished using the driver 70 to advance the anchor 30 distally (e.g., via the catheter 40) toward the interface 110 within the heart while maintaining the position of the wings with the leaflets, and then using the anchor to secure the interface to the heart tissue at site 18. The driver 70 (e.g., its drive head 72) is then disengaged from the anchor 30, the shaft 60 (e.g., its shaft head 62) is disengaged from the interface 110, the tool 50 is removed, and the implant 100 is implanted into the heart (FIG. 2G).

[0708] Reference is again made to FIG. 3, FIG. 4A-B, and FIG. 5, which are schematic illustrations of the valve 10 during the transition from ventricular diastole to ventricular systole, according to some implementations. In each of FIG. 3-5, frames A-D represent sequential snapshots during the transition from ventricular diastole to ventricular systole. When viewed in reverse order, frame DA may be considered to represent sequential snapshots during the transition from ventricular systole back to ventricular diastole. In frames B-D of each of these figures, a series of small arrows pointing upwards represent pressure from the ventricle 8 contracting during ventricular systole. FIG. 3 shows the valve 10 as a healthy valve 10, while FIG. 4A-B shows the valve 10 as a damaged valve 10 in which the leaflets 12 are experiencing flutter 16 (FIG. 4A) or prolapse 19 (FIG. 4B). FIG. 5 shows the valve after implantation of an implant, according to some implementations.

[0709] In a healthy valve 10 (FIG. 3), the leaflets 12 and 14 close synchronously during ventricular contraction, thereby preventing coaptation and retrograde flow into the atrium 6. In a damaged valve 10 (FIGS. 4A-B), flutter 16 or prolapse 19 occurs at a site on the leaflet 12 (e.g., due to one or more damaged chordae tendineae), thereby allowing retrograde leakage into the atrium 6. Previously described treatments for flutter are based on preventing the leaflet from moving toward the atrium (e.g., along the ventricular axis ax3) by implanting a restraining implant in the ventricle (e.g., artificial chordae tendineae) or atrium (e.g., an occlusion frame) that opposes (e.g., directly opposes) the atrial movement of the flutter, thereby requiring substantial strength to counter the force that ventricular pressure exerts on the leaflet. Implant 100 advantageously manipulates or influences the force of ventricular pressure to deflect otherwise atrial motion of leaflet 12 toward the opposing leaflet 14, so that the portion of leaflet 12 that would otherwise flap comes into coaptation with leaflet 14 despite the wings 120 being sandwiched between leaflets 12 and 14.

[0710] This directed coaptation is believed to simulate physiological coaptation in a healthy valve, allowing the leaflets to cooperatively resist ventricular pressure. That is, directed coaptation allows leaflet 14 to provide support to leaflet 12 to resist flutter. Thus, implant 100 advantageously does not require substantial strength that would be necessary to counteract forces exerted by ventricular pressure. Instead, implant 100 advantageously may be secured by a single anchor (although multiple anchors may also be used), may be implanted using a simple and maneuverable delivery system, and wings 120 may be highly flexible. In some implementations, implant 100 and / or its anchoring may be insufficient to directly resist (e.g., close) flutter of leaflet 12 in response to forces from ventricular pressure, but may still reduce or eliminate flutter by (re)orienting the leaflet toward the opposing leaflet.

[0711] A comparison of Figures 4A-B to 5 further illustrates examples of this behavior, but these examples should not be construed as limiting the scope of the present disclosure. In Figures 4A-B, frames B-D show an undamaged leaflet 14 pivoting toward leaflet 12 in response to intraventricular pressure. That is, the ventricular pressure is directed broadly toward the atrium (e.g., along axis ax3), and leaflet 14 moves toward the atrium in response to this pressure, but leaflet 14 also pivots / deflects toward leaflet 12. In a healthy valve, both leaflets behave in this manner, thereby coapting (Figure 3). In contrast, in Figures 4A-B, the damaged leaflet 12 (e.g., flail portion 16 or its prolapsed portion 19) has relatively less movement toward leaflet 14 and therefore does not coapt with leaflet 14. In FIG. 5, the implant 100 (eg, its wings 120 ) redirects the leaflet 12 towards the leaflet 14 to facilitate sealing of the valve 10 .

[0712] In some implementations, as shown, the wings 120 move in response to the cardiac cycle, for example, facilitated by the manner in which the implant 100 is secured and / or by the flexibility of the wings (e.g., of the frame 124). For example, as the treated leaflet is pushed upstream by intraventricular pressure, the leaflet pushes the wings 120 upstream. The transition from Frame A to Frame B in FIG. 5 depicts the implant 100 pivoting as a whole about the anchor in response to the leaflet 12 being pushed against the wings 120, for example, due to the implant 100 being secured only to the interface 110. The transition from Frame B to Frame C in FIG. 5 depicts the wings 120 deflecting against the interface 110 and anchor 30 in response to further pushing of the wings by the leaflet 12, for example, due to the flexibility of the wings (e.g., of the frame 124).

[0713] In some implementations, the portion of the native leaflet being treated (e.g., leaflet 12) still directly coapts to the opposing native leaflet, in some cases, more than 20%, more than 30%, more than 40%, more than 50%, more than 60%, or more than 70% of the native leaflet being treated (or of the coaptation surface of the native leaflet) directly coapts to another native leaflet.

[0714] Furthermore, in some implementations, during at least a portion of the cardiac cycle (e.g., ventricular diastole), the native leaflet to be treated (in this case leaflet 12) separates from the wing 120 (FIG. 5, Frame A), and during another portion of the cardiac cycle (e.g., ventricular systole), the leaflet is pressed against the wing 120 by ventricular pressure. Thus, in some implementations, the wing 120 does not function as a prosthetic leaflet, but rather as a guide and / or support for the native leaflet, helping it to assume the proper configuration for coaptation with the opposing leaflet. In at least some implementations, it is believed that the shape of the wing 120 and / or the position and orientation at which the implant 100 is implanted are such that during systole, the native leaflet molds and / or conforms to the shape of the wing 120. For example, contact between the native leaflet and the wing propagates toward the leaflet lip and the wing tip 132, for example, as shown.

[0715] In some implementations, implant 100 (and any of the implants herein) may be beneficially configured to extend beyond (and / or below) the edges of the native leaflets (e.g., when the valve is closed). This may beneficially help ensure that the leaflets assume the correct shape without the need for tips 132 to be fixed to the ventricle or clipped to the edges of the native leaflets.

[0716] In some implementations, the openings in the wings 120 (e.g., holes 140) may facilitate blood flow downstream through the wings 120 during diastole (e.g., pushing the leaflets 12 away from the wings) and allow blood to escape between the leaflets and the wings during the first brief period of systole, thereby allowing the leaflets to quickly flatten against the wings and coapt with the opposing leaflets, and thus facilitating a small regurgitation volume. Uncovered portions of the wings 120 may provide similar benefits. Moreover, such holes or uncovered portions may also facilitate implantation of the implant into a beating heart and allow easier positioning of the implant, for example, because the openings (e.g., holes 140) reduce the amount of circulating blood that may be trapped by the wings, thereby causing undesired movement of the wings or implant. This may likewise help to avoid undesired implant movement after implantation.

[0717] In some implementations, and as shown in FIG. 5, the tip 132 is not fixed to tissue during the implantation process. That is, the tip 132 can be a free tip of the wing. In some implementations where the interface 110 is fixed to the valve annulus 11, the implant 100 may not be attached (e.g., fixed) to the heart downstream of the leaflets of the valve to be treated (e.g., in the ventricle downstream of the valve to be treated). For example, the implant 100 does not include a downstream anchor (e.g., a ventricular anchor). As shown, in some implementations where the interface 110 is fixed to the valve annulus 11, any anchoring of the implant 100 to the tissue of the heart can be provided from the atrium upstream of the valve to be treated.

[0718] In some implementations, the implant 100 can be repositioned and / or removed via the anchor by a driver 70 used to detach the anchor interface 110 from the tissue after fixation of the implant to the tissue (e.g., by unscrewing the anchor 30).

[0719] The simplification of repositioning of the implant 100 is possible at least in part due to the simplification of the implant itself and / or its anchoring (e.g., to the valve annulus). Also, because the shaft 60 holds the implant 100 in the position where it is potentially anchored (e.g., because the shaft holds the interface 110 at (e.g., relative to) each site 18 where the interface will potentially be anchored), and because subsequent anchoring of the implant results in minimal (e.g., no) change in the position of the implant, the determination of position optimality described above is particularly accurate and reliable for the system 20. This advantage may be further facilitated by full deployment of the wings 120 (e.g., the entire implant 100) prior to placing the implant in each position.

[0720] Additionally, if the decision is made to abort the implantation after implant 100 has been deployed in the atrium, the implant can be withdrawn into catheter 40 and out of the subject by simply retracting shaft 60 into the catheter. The shape and flexibility of wings 120 facilitates the wings being recompressed upon their re-entry into the catheter. If interface 110 has already been secured before the decision to abort is made, driver 70 may be used to detach anchor 30 prior to retraction of shaft 60.

[0721] Further, with regard to the simplification of the implant 100, in some implementations, the implant 100 consists essentially of the interface 110 and the wings 120 (ie, the frame 124 and the sheet 126).

[0722] In some implementations, as shown, the driver 70 can be disposed within the shaft 60 and the anchor 30 can be advanced through the shaft. In some implementations, as shown, the driver 70 and anchor 30 can be present within the shaft 60 throughout the procedure (e.g., during deployment of the wings 120). In some implementations, the driver 70 and anchor 30 can be introduced into the shaft 60 after the implant 100 has been introduced into the heart.

[0723] The anchor 30 may include a tissue engaging element 34, and the driver 70 may secure the interface 110 to the tissue by driving the tissue engaging element into the tissue. The tissue engaging element 34 may take one of a variety of forms known in the art, such as a helix, a dart, a staple, etc. In the embodiment shown, the tissue engaging element 34 is a helical tissue engaging element that the driver 70 screws into the tissue.

[0724] In some implementations, implant 100 includes an anchor receiver (e.g., exactly one anchor receiver) 150 at interface 110 (or interface 110 includes anchor receiver 150), such that anchoring of the interface to tissue is achieved by anchoring the receiver to tissue. This may itself be achieved by using driver 70 to secure anchor 30 to receiver 150, for example, by driving the anchor through the receiver and into tissue.

[0725] In some implementations, as shown, the receiver 150 defines an opening therethrough and includes an obstruction 152 that protrudes inwardly into or across the opening. In some implementations, the anchor 30 and driver 70 may be configured such that the driver may drive the tissue engaging element 34 past the obstruction 152 until the head 32 is obstructed by the obstruction.

[0726] In some implementations, ring 128 functions as anchor receiver 150 and / or interface 110, for example, without the need for additional mechanisms. For example, shaft 60 may engage ring 128 (thereby causing the ring to function as interface 110) and / or driver 70 may drive anchor 30 through ring 128 until head 32 is obstructed by and pressed against the ring (thereby causing the ring to function as anchor receiver 150).

[0727] FIG 6A illustrates implant 100a, FIG 6B illustrates implant 100b, and FIG 6C illustrates implant 100c. Implants 100a, 100b, and 100c may be considered variations of implant 100. Implants 100a, 100b, and 100c may be identical to one another, except that implant embodiment 100a includes receiver 150a or interface 110 of anchor receiver 150, implant embodiment 100b includes receiver 150b or interface 110 of anchor receiver 150, and implant embodiment 100c includes receiver 150c or interface 110 of anchor receiver 150.

[0728] The receiver 150a includes an exemplary obstacle element 152a of the obstacle 152. The obstacle element 152a is defined by a portion of the sheet 126 that extends over an opening defined by the anchor receiver. During anchoring, the tissue engaging element 34 is driven through and over (e.g., through) the sheet until the head 32 is shielded by (e.g., abuts) the sheet, e.g., pressing / pinching the sheet toward / against the tissue.

[0729] The receiver 150b includes an exemplary obstacle element 152b of the obstacle 152. The obstacle element 152b includes (or is defined by) a crossbar that traverses an opening defined by the anchor receiver. During anchoring, the tissue engaging element 34 is driven over the crossbar until the head 32 is shielded by (e.g., abuts) the crossbar, e.g., presses / pinches the crossbar toward / against the tissue.

[0730] The receiver 150c includes an exemplary obstacle element 152c of the obstacle 152. The obstacle element 152c includes (or is defined by) a collar. During anchoring, the tissue engaging element 34 is driven over the collar until the head 32 is shielded by (e.g., abuts) the collar, e.g., presses / pinches the collar toward / against the tissue. In some implementations, the ring 128 functions as the obstacle element 152c.

[0731] A variety of different types of obstruction elements are also possible, such as, for example, a sheet, a fabric, a pattern, a panel, metal (e.g., a metal sheet, a metal fabric, a metal structure configured to couple with the anchor, etc.), one or more holes (e.g., holes sized to allow the tissue penetrating portion of the anchor to pass but not the anchor head), a crossbar, a collar, a hub, a polymer layer, a mesh, a nut, a threaded portion (e.g., with threads that interact with the anchor to allow tissue penetration but keep the anchor attached to the implant), a stop, etc.

[0732] In some implementations, the implant 100 includes a lateral (e.g., tubular) wall 112 that defines at least a portion of the interface 110 and may have a coupling 114 defined therein. For example, the implant 100 may include a housing 108 that includes or defines the interface 110 (e.g., the wall 112 and its coupling 114) and the receiver 150 (e.g., its obstruction 152). The housing 108 may be formed from a single piece of stock that integrates all of these elements.

[0733] 7, which is a schematic diagram of multiple implants 100 implanted in a single heart valve, according to some implementations. Advantageously, at least in part due to the simplicity of the implant 100, the implant typically allows for the implantation of multiple implants 100 in the same valve. Due to the simplicity of the implant 100 and / or the flexibility of the wings 120, multiple implants could be implanted without preventing the base leaflet from coapting with the opposing leaflet, even when the wings 120 of the implants overlap, for example, as shown.

[0734] Although all three implants 100 in FIG. 7 are shown on the same leaflet, it should be understood that the scope of the present disclosure includes implanting one or more implants 100 on one leaflet of the valve and one or more implants 100 on another leaflet of the valve.

[0735] Furthermore, the implant 100 is compatible with the implantation of other implants, either before or after implantation of the implant 100. For example, because the implant 100 has a relatively small mounting area on the valve annulus, an annuloplasty structure may also be implanted, if desired. Similarly, because the wings 120 are flexible, if it is subsequently determined that the subject requires a prosthetic valve to be implanted in the heart valve (e.g., due to further deterioration of the condition being treated), a transluminally delivered prosthetic valve may be implanted without removing the implant 100, for example, by simply pushing / deflecting the wings 120 laterally by the expansion of the prosthetic valve. The size and simple design of the wings 120 may help ensure that the wings do not obscure the outflow of the implanted prosthetic valve (e.g., thus not requiring removal of the implant).

[0736] Additionally, it may be possible to implant an implant 100 having wings 120 over a portion of a leaflet and perform an edge-to-edge repair (e.g., by implanting a leaflet clip that holds the edges of the leaflets together) that may be performed in another portion of the leaflet not covered by the implant, or in some implementations may be performed over or through a portion of the implant 100.

[0737] Reference is now made to Figures 8 and 9, which are schematic illustrations of the implant 100 according to some implementations, implanted in a different location than that shown above.

[0738] 2A-G and 5, the interface 110 is anchored to the annulus 11, facing the valve 10 and more lateral than the root 13 of the leaflet 12). In contrast, in FIG. 8, the interface 110 is anchored medially from the root of the leaflet, with the tissue engaging element 34 of the anchor 30 penetrating completely through the leaflet and into the wall 9 of the ventricle 8. This causes the portion of the leaflet closest to the root 13 to be pinned to the ventricular wall 9, thereby reducing the effective length of the leaflet. Such an anchoring site may be particularly useful in the event of a prolapsed leaflet.

[0739] In some implementations where this anchor site is used, the interface 110 can be pressed against the leaflet prior to anchoring so that the leaflet is sandwiched between the delivery tool 50 (e.g., its shaft 60) and the ventricular wall 8.

[0740] As shown in Figures 2A-G and 5, the implant 100 is shown as being implanted medially onto the leaflet 12 (e.g., at the P2 scallop). In contrast, in Figure 9, the implant 100 is implanted more laterally onto the leaflet, e.g., near or at the commissure 15 of the valve 10. The flexibility of the wings 120 may allow the wings to conform to the anatomy while still improving coaptation. Furthermore, this flexibility may make the implant 100 particularly suitable for implantation at such sites compared to more rigid implants that may, for example, prevent the first leaflet from moving towards and coapting with the opposing leaflet. In the illustrated embodiment, the implant 100 is implanted in a position and orientation where the wings 120 are asymmetrically deflected to promote coaptation between the P3 scallop of leaflet 12 and the A3 scallop of leaflet 14 at the commissure 15. In some implementations, the two-loop structure of the wing 120 may facilitate such asymmetric deflection, for example, allowing the wing to fold along the central longitudinal axis of the wing (e.g., on which resides the cross section indicated by indicator A in FIG. 1A ).

[0741] Reference is now made to Figure 10, which is a schematic diagram of an implant 100d according to some implementations. Implant 100d is substantially identical to implant 100 described above, mutatis mutandis, except that implant 100d is secured using multiple anchors. In some implementations, implant 100d may include multiple individual anchor receivers 150, or multiple anchors may be received by a single anchor receiver or interface.

[0742] In some implementations, as shown, implant 100d may have a single interface 110 and / or a single anchor receiver 150 that receives a single anchor 30, with additional anchors 30a driven through seat 126 proximate interface 110 (e.g., rather than being received by a separate anchor receiver). In some implementations, implant 100d may include multiple interfaces 110, each with a respective anchor receiver. In some implementations, implant 100d (e.g., its anchor interfaces) is configured to receive multiple anchors at different angular arrangements, e.g., such that the multiple anchors cooperate to provide improved anchor fixation.

[0743] 11A, 11B, 11C, and 11D are schematic diagrams of an exemplary system 20a for use with a valve of a subject or simulated heart 4 according to some implementations. In some implementations, the system 20a may be used with a mitral valve 10 of a heart, where the heart chamber upstream of the mitral valve is the left atrium 6 and the heart chamber downstream of the mitral valve is the left ventricle 8, similar to the heart chambers of the system 20 described above with respect to FIGS. 1-10, mutatis mutandis. Similarly, the system / apparatus may also be used with other atrioventricular valves (tricuspid valves), mutatis mutandis, from which another atrium (right atrium) is upstream and another ventricle (right ventricle) is downstream. The system 20a may also be used with a vena cava or pulmonary valve, where the upstream heart chambers are the ventricles (left and right ventricles, respectively).

[0744] In some implementations, the system 20a includes the implant 100e and may be used with the anchor 30, a delivery tool (such as the tool 50 or a variation thereof), and a catheter that may or may not be a component of the delivery tool.

[0745] In some implementations, the implant 100e is substantially identical to the implant 100 disclosed above, mutatis mutandis, except that the implant 100e includes an adjustment node 252 and an adjustment element 255.

[0746] In some implementations, the implant 100e includes a flexible wing 220 and an anchor receiver 250 coupled to the wing. The wing 220 can have a contact surface 222 and an opposing surface 223 opposite the contact surface.

[0747] In some implementations, the wings 220 can have a flexible frame 224 that can define adjustment nodes 252. In some implementations, the adjustment nodes 252 can be used to adjust the size, shape, and / or width of the frame 224 and / or the wings 220 within the heart.

[0748] In some implementations, as shown, the adjustment element 255 may extend from the adjustment node 252 (e.g., from the point where the adjustment element connects to the adjustment node) to a fixed node on the implant. For example, a first end of the adjustment element 255 may be connected to the adjustment node 252, while a second end of the adjustment element may be connected or connectable to the fixed node. In some implementations, the fixed node may be a frame, an anchor receiver, a second / another adjustment node and / or anchor receiver, or a section of a wing or any portion thereof. Although the term "fixed" node is used, it should be understood that this node may be an adjustment node as well or may facilitate adjustment of the adjustment element.

[0749] In some implementations, the adjustment node 252 may be connected to a fixed node (which may be, for example, in another part of the wing) via an adjustment element 255. The adjustment element 255 may be manipulated (e.g., pulled / tensioned or pressed / compressed) to apply a force to the frame 224. The force applied to the frame may cause the frame to change its shape (e.g., its width or length), for example, by contracting and / or expanding.

[0750] In some implementations, the flexibility of the frame 224 allows it to deform, e.g., compress and / or expand, such that the distance between the adjustment node 252 and the fixed node may be alterable within the heart. FIGS. 11A and 11B show an implant 100e in which the adjustment element 255 is in the form of a tether 255a or other tensioning element. The tether 255a is shown connected at its first end to the wing portion 225 and slidably coupled (e.g., screwed) to the adjustment node 252 according to some implementations. FIG. 11A shows the tether 255a and wings 220 at rest, e.g., with the tether 255a not under tension and not applying any force to the wings. FIG. 11B shows the tether 255a tensioned and fastened at the adjustment node 252 by fastener 253, with the excess of the tether trimmed.

[0751] In some implementations, this tension causes tether 255a to apply a force to wing 220 (e.g., its frame 224), pulling component 225 towards adjustment node 252. In some implementations, fastener 253 can be a bead, lock, clasp, tie, bolt, or any other element configured to fasten and hold tether 255a to adjustment node 252.

[0752] In some implementations, a change in the shape of the frame, e.g., compression or expansion, may cause the adjusted distance d2 between the adjustment node and the fixed node to be less than the original distance d1 between the adjustment node and the fixed node, or vice versa. The change between the original distance d1 and the adjusted distance d2 may cause a deformation of the frame 224 that may reduce the width of the wing (e.g., the distance between its lateral sides 234, i.e., 234a and 234b). In some implementations, the adjustment element may be directly or indirectly connected to any portion of the frame, additional adjustment nodes, additional anchor receivers, and / or anchor receiver 250. As shown, tether 255a pulls part 225 toward adjustment node 252, which in turn reduces the width w2 of the wing, e.g., relative to the rest width w1.

[0753] 11C is a schematic diagram of implant 100e', which is identical to implant 100e unless noted otherwise. In implant 100e', adjustment node 252 is connected to anchor receiver 250 by adjustment element 255 in the form of tether 255a. That is, the fixed node is anchor receiver 250. As shown, tether 255a is connected at its first end to anchor receiver 250 and threads through adjustment node 252. Tensioning tether 255a applies a force to frame 224 such that the tether pulls anchor receiver 250 toward adjustment node 252.

[0754] In some implementations, a change in the shape of the frame, e.g., compression or expansion, may cause the adjusted distance d3 between the adjustment node 252 and the anchor receiver 250 to be smaller than the rest / original distance. The difference between the original distance d1 and the adjusted distance d3 may cause a deformation of the frame 224, which in some implementations may reduce the wing's width w3 and / or length (e.g., the distance between its lateral sides 234, i.e., 234a and 234b).

[0755] FIG. 11D is a schematic diagram of implant 100e″, which is identical to implant 100e unless noted. In implant 100e″, adjustment node 252 is connected to anchor receiver 250 by adjustment element 255 in the form of compression member (e.g., beam, bar, or post) 255b. As shown, compression member 255b can apply an expansion force to frame 224, for example, by compression member 255b pushing anchor receiver 250 away from adjustment node 252. In some implementations, the expansion force applied to frame 224 can be used to increase a dimension (e.g., width w4 and / or length) of wing 220. As shown, compression member 255b pushes anchor receiver 250 away from adjustment node 252, which in turn increases wing width w4.

[0756] In some implementations, the coordination node may have a variety of different sizes and / or shapes. For example, the coordination node may be equal in size to the anchor receiver, smaller in size than the anchor receiver, or larger in size than the anchor receiver. The coordination node may have a variety of shapes, such as round, oval, square, etc. In some implementations, the coordination node 252 is smaller in size than the anchor receiver 250, as shown in FIGS. 11A-11D. Note that in some implementations, the coordination node 252 may also function as an additional anchor receiver, similar in function to the anchor receiver 250. In some implementations, the coordination node may be a lacing hole or a grommet.

[0757] See Figures 12A, 12B, 13A, 13B, 14, 15A, 15B, 16A, and 16B. According to some implementations, Figures 12A-B show implant 200, Figures 13A-B show implant 200a, Figure 14 shows implant 200b, Figures 15A-B show implant 200c, and Figures 16A-B show implant 200d.

[0758] As shown, implants 200, 200a, 200b, 200c, 200d are generally similar to implant 100 disclosed above, mutatis mutandis, except that implants 200, 200a, 200b, 200c, 200d each include at least two anchor receivers 250, 350. Components with the same name between the implants typically share similar features and perform similar functions as one another. Accordingly, the following description of implants 200, 200a, 200b, 200c, 200d will focus on features specific to these implants.

[0759] The frames 224, 324 of the implants 200, 200a, 200b, 200c, 200d may be sufficiently flexible to allow the distance between the anchor receivers 250, 350 to be varied within the heart.

[0760] In some implementations, changing the distance between the anchor receivers 250, 350 can affect the size and / or shape (e.g., width and / or length) of the frame 224, 324 and / or the wings 220, 320. That is, the difference between the rest distance d5 between the first and second anchor receivers and the adjusted distance between the two receivers (e.g., after adjusting the implant by changing the position / distance between the first and second anchor receivers) can result in a deformation of the frame 224 that can make the adjusted width of the wing smaller or larger than that of the rest width w5 of the wing.

[0761] In some implementations, an adjusted angle different from the static angle may be created between the two anchor receivers. Achieving the adjusted angle may cause deformation of the frame, which in turn may affect the width and / or shape of the wings.

[0762] In some implementations, the anchoring position of the second anchor receiver relative to the anchoring position of the first anchor receiver may result in an adjustment of the distance between the anchor receivers. For example, a delivery tool coupled to both anchor receivers may be used to adjust the distance between the anchor receivers prior to anchoring one or both of the anchor receivers. Alternatively or additionally, the delivery tool may adjust the distance by manipulating components of the implant, for example, in a manner similar to that described above with respect to Figures 11A, 11B, 11C and / or 11D, mutatis mutandis.

[0763] As shown in FIG. 12A, the implant 200 includes a first anchor receiver 250, 250a and a second anchor receiver 250, 250b. In some implementations, each anchor receiver 250 can be secured by a respective anchor 30. Alternatively or additionally, both anchor receivers 250 can be secured by a single anchor spanning both anchor receivers, e.g., via a single staple anchor 31 (FIG. 12B). As shown, the staple anchor 31 has multiple (e.g., two) legs, each of which passes through a respective anchor receiver and secures the anchor receiver to tissue of the heart (e.g., tissue of the annulus). In some implementations, a central section 255c of the anchor (e.g., a portion of the anchor connecting the legs of the anchor) can function as an adjustment element, e.g., by being plastically deformable. Thus, in some implementations, the anchor 31 can also function as an adjustment element.

[0764] In some implementations, as shown, the wing 220 includes a frame 224 (e.g., a wire nitinol, stainless steel, and / or polymer frame) and a sheet 226 that extends over a portion of the frame. In some implementations, the wing 220 has at least one root 230, e.g., a first root 230a and a second root 230b, each coupled to an anchor receiver 250, and a tip 232 at an opposite end of the wing from the root. The tip 232 represents a free end of the wing 220. The anchor receiver 250 can be secured to the annulus of the valve in a manner such that the wing 220 extends over the first leaflet, away from the anchor receiver, toward the opposing leaflet (i.e., the second leaflet), with the contact surface 222 facing the first leaflet, for example, in a manner similar to that described above with respect to the implant 100.

[0765] In some implementations, as shown, at the root 230, the frame 224 may define a ring that fits around the anchor receiver 250. In some implementations, the ring may function as a "flat" anchor receiver, such as anchor receiver 350 described below. The wing 220 may define two lateral sides 234 (e.g., first lateral side 234a and second lateral side 234b) that extend from the root to the tip.

[0766] In some implementations, as shown, the frame 224 defines two loops 236 (e.g., a first loop 236a and a second loop 236b) that extend from the root 230 toward the tip 232, e.g., with the two loops parallel to each other. Note that the loops 236 can be separate loops that can be connected to each other. In some implementations, the frame 224 is formed from a single flexible wire. The loops 236 can be connected to each other (e.g., at the tip) and / or to any other components of the implant 200 (e.g., metal components). However, each of the loops 236 can enclose a space 237 that is substantially free of frame components (optionally, in the case of tuning nodes, except in implementations with tuning nodes located on the wings).

[0767] In some implementations where the frame 224 defines the loop 236, the frame 224 defines an adjustable space 238 between the two loops. The space 238 can extend from the root 230 towards the tip 232, for example all the way to the tip, and in some implementations the frame 224 bridges the two loops at the tip. In some implementations, as shown, the space 238 extends along the plane of reflective symmetry of the wings 220 when placed in the implant rest position / shape.

[0768] In some implementations, adjustment of the distance between the anchor receivers is facilitated primarily by the space 238 becoming wider or narrower, for example, without the loops 236 themselves substantially changing shape. For example, the loops 236 may pivot / articulate toward one another, with the wing tips serving as pivot / articulation points. Alternatively or additionally, adjustment of the distance between the anchor receivers is facilitated by compression or expansion of the loops 236.

[0769] In some implementations in which the frame 224 defines loops 236, the sheet 226 may extend over and between the loops, for example across both loops and the spaces 238.

[0770] In some implementations, as shown, the sheet 226 extends only partway from the tip towards the root, such that, for example, a zone 227 of the wing near the root and / or anchor receiver is substantially open / uncovered. Although zone 227 is shown and labeled only in FIG. 12A, other implants described herein (e.g., wings thereof) may have such zones, whether or not shown.

[0771] In some implementations, the shaft may position the implant 200 within the heart in a state of the implant that is different from the rest state of the implant. This may be accomplished by positioning and / or fixing the first anchor receiver 250a at a first location of the heart and then positioning and / or fixing the second anchor receiver 250b at a second location of the heart, which results in an intracardiac change (e.g., intracardiac adjustment and / or deformation) of the implant. The intracardiac change may cause deformation of the frame, which may in turn affect the shape and / or size of the wings. In some implementations, such adjustment affects (e.g., primarily affects) the shape and / or size of the space 238. For example, positioning the second anchor receiver 250b at a second location close to the first location where the first anchor receiver 250a is positioned may reduce the size of the space 238. In contrast, positioning the second anchor receiver 250b at a second location away from the first location where the first anchor receiver 250a is positioned may increase the size of the space 238. In some implementations, such adjustments may alternatively or additionally affect the shape and / or size of spaces 237a and / or 237b.

[0772] In some implementations, the sheet 226 has a plurality of holes therethrough, for example, as described with reference to the implant 100, mutatis mutandis. In some implementations, the holes may be polygonal and interdigitated with one another, similar to those described above with respect to the implant 100. As shown, some of the holes may be disposed above the space 237. Alternatively or additionally, some of the holes may be disposed above the space 238. In some implementations, as shown, the size and number of the holes are such that the wings 220 are generally more than 20 percent and / or less than 80 percent open, e.g., 20-80 percent open, e.g., 20-70 percent open (e.g., 30-70 percent open, e.g., 30-60 percent open or 40-70 percent open) or 30-80 percent open (e.g., 40-80 percent open). Additionally or alternatively, the sheet 226 may be comprised of a material that allows blood and / or plasma to flow therethrough. Sheet 226 may comprise a fabric, a polymer, and / or a tissue such as pericardium. Sheet 226 comprises at least one sheet material selected from the group consisting of polylactic-co-glycolic acid, polyvinyl chloride, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyethersulfone, polyglycolic acid, polylactic acid, poly-D-lactide, poly-4-hydroxybutyrate, and polycaprolactone.

[0773] 13A and 13B are schematic diagrams of an implant 200a including an adjustment element 255b in the form of a compression member (such as a rod or bar, as shown). In the illustrated embodiment of the compression member 255b (e.g., FIG. 11D and FIG. 13A-B), the compression member includes a threaded fastener operable to increase and / or decrease the length of the compression member.

[0774] In some implementations, instead of a compression member, the adjustment element of implant 200a can be a tether, such as tether 255a shown in FIG. 11C. In some implementations, the adjustment element can be in the form of a tether that can be threaded through each of the anchor receivers such that the anchors can secure the corresponding anchor receiver to tissue without detaching the tether from the corresponding anchor receiver.

[0775] In some implementations, the implant 200a is adjusted prior to anchoring. In some implementations, the implant 200a can be implanted without first removing the adjustment element 255b.

[0776] In some implementations, the implant 200b is adjusted after anchoring. Note that changing the distance between the anchor receivers after they are anchored to the cardiac tissue can cause the cardiac tissue disposed between the anchor receivers to contract (e.g., plicate) or expand.

[0777] As shown in FIGS. 12A-B, d5 can be considered to be the rest distance of implants 200a, 200b, and 200c, and w5 (the distance between lateral sides 234a and 234b) can be considered to be the rest width of these same implants.

[0778] 13A illustrates the use of compression members 255b to apply an expansion force to the frame 224 of implant 200a by pushing anchor receivers 250 apart. In some implementations, and as shown in FIGS. 13A-B, compression or expansion of adjustment element 255b can result in an adjusted distance greater (d6, FIG. 13A) or less (d7, FIG. 13B) than d5.

[0779] Use of an expansion force applied to the frame 224 can increase a dimension (e.g., width) of the wing 220, which in turn increases the width w6 of the wing, for example, relative to the rest width w5. In some implementations, the transition from the rest distance d5 to the adjusted distance d6 or d7 increases or decreases the width of the wing 220. In some implementations, this transition causes the loops 236a, 236b to translate and / or pivot relative to one another (e.g., at the tips 232).

[0780] Additionally, the space 238 is larger (e.g., wider) in FIG. 13A compared to FIG. 12A, e.g., as a result of the expansion force applied by the compression member of FIG. 13A. FIG. 13B illustrates the use of compression member 255b to apply a contraction force to frame 224 of implant 200a, e.g., compression member 255b pulls two anchor receivers 250 toward each other. The use of a contraction force can reduce a dimension of wing 220 (e.g., width d7), e.g., relative to rest width w5. As illustrated, the space 238 is smaller (e.g., narrower) in FIG. 13B compared to FIG. 12A.

[0781] Reference is now made to FIG. 14, which is a schematic diagram of an implant 200b, which may be considered a variation of the implant 200 and may be similar to the implants 100 and 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., anchored to cardiac tissue to restore the function of the native valve leaflets, except that the implant 200b includes the use of an adjustment element in the form of a tether. As shown, the tether 255a is connected at its first end to a first adjustment node 252a and at its second end to a second adjustment node 252b. Tensioning the tether 255a pulls the adjustment nodes 252 towards each other, thereby contracting the frame of the implant 200b. Using a contraction force applied to the frame 224, the dimensions (e.g., width) of the wings 220 may be reduced, which in turn reduces the width w8 of the wings, e.g., relative to the resting width w5. As shown, the space 238 shown in FIG. 14 is reduced relative to the space 238 shown in FIG. 12A. Tether 255a may be fastened by fastener 253 to one or both of adjustment nodes 252a and 252b.

[0782] Although not shown, in some implementations, one or more of the adjustment nodes of any of the implants described herein may be defined by the sheet (e.g., rather than the frame) of the implant. Such adjustment nodes may be referred to as sheet adjustment nodes. Similarly, in some implementations, one or more of the anchor receivers of any of the implants described herein may be defined by the sheet (e.g., rather than the frame) of the implant. Such anchor receivers may be referred to as sheet anchor receivers. For example, the sheet adjustment nodes and / or sheet anchor receivers may be formed from the sheet 226 or any portion thereof, such as holes 240 or other dedicated holes and / or loops formed in the sheet. Thus, the sheet adjustment nodes and / or sheet anchor receivers may be spaced apart from the frame 224, for example, positioned over the spaces 237 and / or 238. Additionally or alternatively, the sheet 226 may be configured to apply a force to the flexible frame to change the width of the implant within the heart.

[0783] In some implementations, for example, when the implant includes an adjustment element as described above, the delivery tool may include an adjustment actuator configured to engage the adjustment element and adjust the length of the adjustment element. For example, the adjustment actuator can adjust the length of the adjustment element, which in turn can change the distance between two points to which the adjustment element is attached, e.g., the adjustment element can change the distance between two anchor receivers attached thereto. In some implementations, adjusting the distance between the anchor receivers after the anchor receivers are secured to tissue (e.g., by anchors) can also result in deformation, such as contraction or expansion, of the valve annulus.

[0784] Reference is now made to Figures 15A and 15B, which are schematic illustrations of implant 200c, which may be considered a variation of implant 200 and may be similar to implants 100 and 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., being fixed to cardiac tissue so as to restore the function of the native valve leaflets, except that the sheet of the implant is replaced by a braided mesh 226' which performs a similar (e.g., substantially identical) function to the sheet.

[0785] In some implementations, the braided mesh 226' may have multiple gaps therethrough and may be configured to seat against the first leaflet. The gaps in the braided mesh 226' may allow blood and / or plasma to flow therethrough while maintaining implant function, similar to the holes 240 described above, for example. In some implementations, the braided mesh may be flexibly fixable such that its shape and / or size may be adjusted and then maintain its adjusted shape and / or size. Thus, through the use of the braided mesh 226', the shape and / or size of the implant and / or wings may be adjusted within the heart.

[0786] While the sheet 226 may facilitate contraction of the implant by sheet rampling, in some implementations the braided mesh 226' may facilitate contraction of the implant without rampling, e.g., via sliding of wires of the mesh over one another. In some implementations the braided mesh 226' may act as an adjustment element, e.g., manipulating the braided mesh may itself adjust the shape and / or size of the implant. In some implementations the braided mesh may impart inherent stability onto the implant for multiple shapes and / or sizes of the implant and / or its wings (including, in some implementations, inherent stability across a continuum of shapes and / or sizes), e.g., such that locking is not required.

[0787] In some implementations, the implant 200c, or any portion thereof, may be adjusted prior to anchoring of the first anchor and / or without the use of any adjustment element or adjustment node. Additionally or alternatively, the implant, or any portion thereof, may be adjusted after anchoring the first anchor receiver 350a and / or the second anchor receiver 350b to tissue using a bleed mesh.

[0788] Figure 15A shows implant 200c having a distance d9 between the two anchor receivers that is smaller than the distance d10 between the two anchor receivers shown in Figure 15B. As shown, adjusting the distance between the two anchor receivers can change the orientation (e.g., angle) of the wires of mesh 226' relative to one another.

[0789] In some implementations, the above-mentioned properties of the mesh 226' may be imparted by the materials used (e.g., metals such as Nitinol or stainless steel, and / or polymers) and / or the structure of the braid (e.g., distance between wires, wire thickness, wire density). The flexibly fixed nature of the mesh 226' may allow such easy adjustment of the frame and / or maintain the adjusted shape and / or size without the use of adjustment elements.

[0790] In some implementations, the use of available adjustment options such as a braided mesh, one or more anchors, two or more anchor receivers, the use of force applied by one or more adjustment nodes and / or sheets, and / or the use of one or more adjustment elements (e.g., different varieties thereof that can apply expansive or compressive forces) may allow for multiple adjustment options for the frame and / or wings, such as changes in the shape, width, size, area, contact surface of the contact surface, implant to the leaflet, applied pressure of the wings and / or contact surface, or any combination thereof, depending on the individual subject.

[0791] In some implementations, the braided mesh 226' also serves as a frame for the implant. That is, in some implementations, each of the implants described herein as including a frame and a sheet may be replaced with an implant that includes the braided mesh 226' rather than a separate frame or separate sheet. In some implementations, the implant may include a braided mesh that serves as a frame for the implant and further includes a sheet covering at least a portion of the frame.

[0792] 16A and 16B. In general, the implant may include several additional anchor receivers, e.g., three or more anchor receivers. For example, the implant may include, for example, a central anchor receiver, a first side anchor receiver, and a second side anchor receiver, each anchor receiver coupled to a wing. Similar to the implants disclosed above, the anchor receiver may be configured to be secured to the valve annulus in a manner in which the wing extends away from the anchor receiver toward the opposing leaflet (i.e., the second leaflet) and over the first leaflet, with the contact surface facing in the direction of the first leaflet. In some implementations, the frame may allow the distance between at least two of the anchor receivers to be altered within the heart.

[0793] 16A and 16B are schematic diagrams of implant 200d, which may be considered a variation of implant 200 and which may be similar to implants 100 and 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., for being fixed to cardiac tissue to restore the function of native valve leaflets, except that implant 200d includes three anchor receivers.

[0794] In some implementations, implant 200d can include anchor receivers 350a and 350b that function as side anchor receivers, and a third anchor receiver 350c that functions as a central anchor receiver 350c. In some implementations, frame 324 of implant 200d can be formed from a single flexible wire that can be optionally coupled to and / or define the anchor receivers. For example, as shown, at root 330 (e.g., root 330a, root 330b, and root 330c), frame 324 can define ring 328 that can fit around and / or form part of anchor receiver 350.

[0795] The frame 324 can define two portions of the wing 320, such as a first portion 336a and a second portion 336b. The portions 336a and 336b are disposed at least partially laterally to one another in at least some configurations of the implant 200d, but in at least some configurations of the implant, the portions at least partially overlap.

[0796] A first lateral side of the wing of implant 200d is defined by a first lateral side 334a of first portion 336a. A second lateral side of the wing of the implant is defined by a first lateral side 334b ​​of second portion 336b. First portion 336a may also have a second lateral side 334c, and second portion 336b may also have a second lateral side, which do not define a lateral side of the wing of the implant, but instead typically at least partially overlap with another portion of the implant.

[0797] The wing 320 can include a first sheet 326a and a second sheet 326b, each of which extends across a respective portion of the frame. In some implementations, when the first sheet 326a and the second sheet 326b cover a respective portion, such as the first portion 336a and the second portion 336b, the covered portion can resemble a feather or scale-like element.

[0798] Portions 336a and 336b, and thereby sheets 326a and 326b, may overlap, thereby defining overlap portion 338. Overlap portion 338 may alternatively or additionally be considered the space between side 334c and side 334d. Overlap portion 338 may extend from anchor receiver 350c and / or root 330c toward tip 332, for example, all the way to the tip. In some implementations, overlap portion 338 extends along a plane of reflective symmetry of wing 320. However, upon adjustment of the implant, the implant may be moved laterally.

[0799] In some implementations, lateral sides 334c and 334d intersect with one another at intersection point 334e. Although intersection point 334e is shown to be located on a plane of reflective symmetry of the implant and / or wing, upon adjustment of the implant, the implant may be moved laterally, for example, closer to lateral side 334a or lateral side 334b.

[0800] In some implementations, the frame may allow for variation in the distance between first lateral anchor receiver 350a and second lateral anchor receiver 350b within the heart in a manner that varies the overlap between the first sheet and the second sheet. The ability to vary the overlap of portions 336a and 336b may facilitate adjustment of implant 200d (e.g., adjusting the distance between its anchor receivers), for example, without fracturing the sheets of the implant.

[0801] In some implementations, changing the relative positions (e.g., the distance between) of the first and second side anchor receivers 350a, 350b may change the shape of the overlap portion 338 between the first and second sheets 326a, 326b. For example, in some implementations, moving the anchor receivers further away from each other may change the overlap portion 338 to a thinner shape. Similarly, in some implementations, moving the anchor receivers closer to each other may change the overlap portion 338 to a wider and / or rounder shape.

[0802] In some implementations, changing the relative positions (e.g., the distance between) of the first side anchor receiver 350a and the second side anchor receiver 350b may change the size of the area of ​​the overlap portion 338. For example, in some implementations, moving the anchor receivers further away from each other may decrease the total area of ​​the overlap portion 338. Similarly, in some implementations, moving the anchor receivers closer to each other may increase the total area of ​​the overlap portion 338, or vice versa.

[0803] In some implementations, the frame may allow for variation in the distance between the central anchor receiver 350c relative to the lateral anchor receivers 350a and 350b. For example, the frame may allow for intracardial variation in the distance between the first and second lateral anchor receivers and the central anchor receiver, e.g., in a manner that varies the overlap between the first and second sheets. In some implementations, the distance between the first and second lateral anchor receivers 350a and 350b and the central anchor receiver 350c may change the shape and / or size of the overlap portion 338 between the first and second sheets 326a and 326b. For example, positioning the central anchor receiver 350c closer to the wing tips 332 may make the overlap portion 338 more elongated. Alternatively, positioning the central anchor receiver further away from the tips, e.g., past the roots 330a and 330b, may make the overlap portion 338 more elongated.

[0804] It should be noted that the shape of the overlapping portion may be altered while maintaining the total overlapping area, and vice versa. For example, having the overlapping portion have a narrower but longer shape, or a wider but shorter shape, may be accomplished without changing the total overlapping area. Changes in the shape and / or area of ​​the overlapping portion may be tailored, for example, based on the individual subject.

[0805] Similar to the implants disclosed above, the width of implant 200d may be determined by the distance between first lateral anchor receiver 350a and second lateral anchor receiver 350b. Additionally or alternatively, a change in the shape and / or size of overlapping portion 338 may result in a change in the width of the wing contact surface. A change in the wing contact surface may in turn result in a change in the width of the implant.

[0806] In some implementations, one or more of the anchor receivers of the implant may be left unanchored relative to the tissue of the heart. For example, one of the side anchor receivers may be left unanchored. In some implementations, the central anchor receiver of implant 200d may be left unanchored. For example, a decision may be made (e.g., by a physician) to leave the anchor receivers unanchored for anatomical reasons, such as the presence of a mechanical obstruction or tissue inadequacy (e.g., the presence of an underlying vessel).

[0807] In some implementations, the central anchor receiver 350c of the implant 200d may be omitted and replaced with a hinge or pivot point, such as a loop, formed by a frame.

[0808] In some implementations, the implant may include two or more adjustment elements (e.g., in the case of an implant with two adjustment nodes and at least one anchor receiver, and / or an implant with two anchor receivers and at least one adjustment node). The adjustment elements may be connected to different portions of the implant. For example, a first adjustment element may connect a first adjustment node to a first anchor receiver, while a second adjustment element may connect the first adjustment node to a second adjustment node, thereby facilitating deformation of the frame in several directions. As another example, a first anchor receiver may be connected to a second anchor receiver by a first adjustment element, and a first adjustment node may be connected to a second adjustment node by a second adjustment element.

[0809] See Figures 17A-D, 18, and 19A-B. In some implementations, one or more of the implants described herein may further comprise a mounting indicator. The mounting indicator may be configured to indicate sufficient and / or complete contact and / or engagement between the anchor receiver of the implant and the tissue of the heart to which the anchor receiver is secured. For example, the mounting indicator may indicate that at least a majority of the contact surface of the anchor receiver is in contact with tissue. This may be used, for example, prior to anchoring to verify that the anchor receiver is optimally positioned for anchoring, and / or after anchoring has begun to verify that the anchor receiver has been optimally secured (e.g., the anchor has been sufficiently driven into the tissue).

[0810] In some implementations, the attachment indicator can be a mechanical indicator (e.g., a mechanical pressure indicator). In some implementations, the attachment indicator can be an electrical sensor (e.g., an electrical pressure sensor).

[0811] 17A and 17B are schematic diagrams of an implant 100f that may be considered a variation of the implant 100 and may resemble the implant 100 disclosed above, mutatis mutandis, at least in its general purpose, i.e., anchored to cardiac tissue to restore the function of the native valve leaflets, except that the implant 100f includes a mechanical attachment indicator 160. The indicator 160 may be in the form of a spring or spring-like element that may be connected to a contact surface of the anchor receiver. In some implementations, the attachment indicator 160 is compressed against the tissue during anchoring of the implant. Fluoroscopic visualization (e.g., when viewed from the side, as illustrated in FIG. 17B) may indicate whether the anchor receiver is positioned in full contact with the tissue, e.g., whether there is a gap between the anchor receiver and the tissue. For example, the attachment indicator 160 (e.g., a spring or another component thereof) may be radiopaque. If the attachment indicator 160 is observed to be short and / or not visible, this may indicate full compression and indicate that the anchor receiver is in full contact with the tissue. It should be noted that a mechanical indicator such as mechanical indicator 160 may be connected to the anchor receiver of any of the implants described herein, mutatis mutandis.

[0812] 17C and 17D are schematic diagrams of an implant 100f' that may be considered a variation of implant 100 and may be similar to implant 100 disclosed above, mutatis mutandis, at least in its general purpose, i.e., anchored to cardiac tissue to restore the function of native valve leaflets, except that implant 100f' includes a spring indicator 166. Indicator 166 may be in the form of a coil (e.g., as shown) or another spring-like element that may be connected to anchor receiver 350 on an opposing surface 223 of implant 100f'. Spring indicator 166 is compressed between the anchor and the implant (e.g., its anchor receiver) during anchoring of the implant. For example, the head of the anchor compresses spring indicator 166 as the anchor is driven through the anchor receiver (FIG. 17D). Due to the resulting energy stored in spring indicator 166, the spring indicator can secure (e.g., press) anchor receiver 350 against tissue even if the anchor is not fully secured in the tissue, for example, if a gap remains between the anchor head and the anchor receiver. Thus, spring indicator 166 can function as a spring washer.

[0813] Fluoroscopic visualization (e.g., when viewed from the side as shown in FIG. 17D) may indicate whether the anchor receiver is positioned in full contact with the tissue, e.g., whether there is a gap between the anchor head and the opposing surface of the anchor receiver. For example, the spring indicator 166 (e.g., the spring or another component thereof) may be radiopaque. If the spring indicator 166 is observed to be short and / or not visible, this may indicate sufficient compression and that the anchor receiver is in full contact with the tissue. However, if three or more coils of the spring indicator 166 are observed, this may indicate that the anchor is not fully secured or has come loose from the tissue. Thus, in addition to the spring washer function described above, the spring indicator 166 may also serve a similar function to the attachment indicator 160, mutatis mutandis. It is noted that a spring indicator such as the spring indicator 166 may be connected to the anchor receiver of any of the implants described herein, mutatis mutandis.

[0814] In some implementations, as shown, indicator 160 and / or indicator 166 are stationary frusto-conical helices, which may facilitate efficient compression of the indicator, for example, by allowing each turn to nest within the adjacent turn, such that if the indicator were fully compressed, it would form a helix.

[0815] FIG. 18 is a schematic diagram of implant 100g which may be considered a variation of implant 100 and which may be similar to implant 100 disclosed above, mutatis mutandis, at least in its general purpose, i.e., secured to cardiac tissue so as to restore the function of the native valve leaflets, and except that implant 100g includes a sensor 162, e.g., an electronic pressure sensor, a biometric sensor, a strain gauge, etc.

[0816] In some implementations, the sensor 162 detects and / or measures pressure between the anchor receiver 250 and tissue. In some implementations, the implant 100g further includes a transmitter 164 through which a signal indicative of the detected and / or measured pressure may be transmitted (e.g., wirelessly) to a receiver that may be located, for example, external to the subject. In some implementations, a delivery tool of the implant 100g is configured to transmit a signal indicative of the detected and / or measured pressure via a wire.

[0817] In some implementations, sensor 162 and / or another sensor (e.g., positioned on an opposing surface of the implant that faces the upstream chamber of the heart, such as the outer surface of the anchor receiver and / or the opposing surface of the wing as shown) can sense intracardiac pressure, such as left atrial pressure, which can be transmitted to a receiver located at a location external to the subject, for example, to monitor the subject's cardiac condition. In some implementations, transmitter 164 can also be positioned on the opposing surface of the implant that faces the chamber, e.g., the outer surface of the anchor receiver.

[0818] Sensors (eg, pressure sensors, etc.), along with transmitters such as sensor 162 and transmitter 164, may be connected to any of the implants described herein, mutatis mutandis.

[0819] In some implementations, although not illustrated, a attachment indicator (either mechanical, radiopaque, and / or electronic) may be part of the delivery tool. For example, the attachment indicator may be disposed on a portion of the delivery tool that is positioned between the anchor receiver and the tissue. The attachment indicator may be connected to an output (e.g., a visual and / or audible output) that indicates contact and / or pressure between the anchor receiver and the tissue.

[0820] In some implementations, the attachment indicator may use a contrast agent introduced into and / or by a portion of the indicator. Generally, systems (e.g., configured for use with live subjects and / or simulated cardiac anchors) that may include, among other components, an implant, a attachment indicator, and a dispenser that may be in fluid communication with the attachment indicator are disclosed below. The attachment indicator may be configured to provide an indication of a state of anchoring of the implant or any component thereof, such as unsecured, semi-secured, and / or fully secured, for use with the heart.

[0821] In some implementations, the attachment indicator may include a hollow needle. The hollow needle may have an outlet. In some implementations, the hollow needle may be fixedly positioned relative to the anchor receiver, for example, such that placement of the anchor receiver relative to tissue places the outlet within the tissue. Through fluid communication between the dispenser and the needle, the needle may dispense contrast agent into the needle and / or out of the outlet. For example, contrast agent may be dispensed to ensure that the anchor receiver is in full contact with the tissue. Based on the presence (e.g., presence vs. absence and / or amount) of contrast agent within the heart (visible with fluoroscopy), it may be determined whether the anchor receiver is placed relative to the tissue.

[0822] In some implementations, the hollow needle is fixedly positioned relative to the anchor receiver such that, when the anchor receiver is in full contact with the tissue and thereby the outlet is disposed within the tissue, contrast agent introduced into the needle is substantially contained within the needle and / or the tissue in which the needle is disposed, for example. However, when the outlet is not fully disposed within the tissue (e.g., because the anchor receiver is not fully disposed relative to the tissue), contrast agent introduced into the needle may be observed to enter the heart chamber, for example, as a transient bulge or cloudiness.

[0823] 19A and 19B are schematic diagrams of a system 21 for use within a heart (e.g., of a live subject and / or a simulation) according to some implementations. System 21 may be used similarly, mutatis mutandis, to that of systems 20 and 20a described above with respect to Figures 1-11. Additionally, features of system 21 may be used to augment other systems and / or implants described herein.

[0824] In some implementations, system 21 includes implant 200e that may be used with anchor 30 and a delivery tool. Implant 200e may be considered a variation of implant 100 or 200 and may be similar to implants 100 and 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., being secured to cardiac tissue to restore the function of the native valve leaflets, and except that implant 200e includes, among other components, attachment indicators in the form of hollow needles (e.g., one per anchor receiver) fixedly positioned relative to at least one of the anchor receivers.

[0825] In some implementations, the implant 200e includes a flexible wing 220 and an anchor receiver 350 coupled to the wing. The wing 220 can have a contact surface 222 and an opposing surface 223 opposite the contact surface.

[0826] In some implementations, the wing 220 can have a flexible frame 224 that can define a first anchor receiver 350a at the root 330a and a second anchor receiver 350b at the root 330b of the implant 200e.

[0827] In some implementations, hollow needles 260 and 261 are fixedly positioned adjacent each of the anchor receivers and point in generally the same direction as the anchors that will ultimately be used to secure the implant.

[0828] In some implementations, each hollow needle includes a first section 260a configured to be inserted into tissue and a second section 260b opposing the first section configured to be disposed within a chamber of the heart while the first section is disposed within the tissue. In some implementations, the first section 260a is in fluid communication with the second section 260b, which can be placed in fluid communication with a dispenser 270, for example, as shown in FIG. 19B.

[0829] In some implementations, the first section 260a defines at least one outlet 262 configured to allow for the exit of contrast agent therethrough. In some implementations, as shown, the section 260a defines multiple outlets 262 (e.g., the first section may be perforated). The at least one outlet may be defined at a distal tip of the needle. In some implementations, multiple outlets 262 may be defined in a lateral wall of the needle, e.g., distributed along the first section 260a.

[0830] In some implementations, having multiple exit / perforations 262 disposed along the first section may provide enhanced viewing during the anchoring procedure. For example, as the anchor is progressively driven into tissue and the anchor receiver 350 progressively approaches the tissue, the hollow needle is inserted progressively deeper into the tissue, thereby progressively blocking more of the exit / perforations and resulting in progressively less contrast leaking into the heart chambers.

[0831] In some implementations, the system 21 may further comprise a delivery tool, which may be considered to be a variation of the delivery tools described above and / or below, mutatis mutandis, except that the delivery tools of the present disclosure may be configured to deliver or further comprise a dispenser 270. The dispenser 270 may be a component of the delivery tool and may be placed in fluid communication with the hollow needle 260 during (e.g., as a result of) coupling the delivery tool to the implant 200e (e.g., coupling the shaft 60 to the anchor receiver 350), as shown in Figures 19A and 19B. In some implementations, this coupling may be performed outside the subject, for example, during manufacture or immediately prior to use.

[0832] In some implementations, the dispenser 270 is configured to deliver the contrast agent from a source located outside the subject. In some implementations, the dispenser 270 is configured to deliver the contrast agent from a source located within a delivery tool. The distal end 270a of the dispenser 270 can be configured to engage with the second section 260b of the hollow needle 260 such that the contrast agent can be delivered from the source to the hollow needle, i.e., such that the dispenser and the source can be in fluid communication with the second section of the hollow needle. For example, the distal end 270a of the dispenser can be removably attached to the second section 260b, through which the dispenser 270 can deliver the contrast agent, for example, from the source to the hollow needle 260. Because the second section 260b is in fluid communication with the outlet 262, the delivered contrast agent can thus be dispensed through the outlet 262.

[0833] In some implementations, the dispenser 270 may include a connection port 271 positioned at a distal end 270a of the dispenser. The connection port 271 may be configured to be in fluid communication with the second section 260b, which may include a seal, e.g., seal 264. In some implementations, the connection port 271 may be configured to be removably attached to the seal 264, e.g., to enable a sealed fluid communication connection between the dispenser 270 and the second section 260b of the needle, and then be removed.

[0834] The scope of the present disclosure includes modifying any of the other implants described herein to include and / or be used with any of the attachment indicators described with reference to Figures 17A-19B, mutatis mutandis. Additionally, the attachment indicator may be coupled to a portion of the implant other than the anchor receiver, such as a wing. Although shown with an implant with two anchor receivers, a attachment indicator such as a hollow needle may be used with an implant with a single anchor receiver, and / or with three or more anchor receivers. When using an implant with two or more anchor receivers, the hollow needle may be positioned adjacent to all or some of the anchor receivers.

[0835] In some implementations, not shown, hollow needle 260 may be a component of a delivery tool rather than an implant. For example, the hollow needle may be secured to a shaft (e.g., shaft 60) or connector (e.g., connector 80, described below) such that upon anchoring of the corresponding anchor receiver, the hollow needle is positioned adjacent to the corresponding anchor receiver.

[0836] In some implementations, the hollow needle may be configured to stabilize the implant relative to tissue, e.g., when coupled and / or removably attached to the implant and / or any portion thereof. For example, upon insertion of a first section of the hollow needle into tissue, e.g., upon fixation of the implant, the hollow needle may prevent the implant from pivoting about a central axis of the anchor receiver and / or about a central axis of the anchor. Thus, in some implementations, the hollow needle may be considered to be a lance or spike having functionality similar to one or more of the lances and / or spikes described below.

[0837] Reference is now made to Figures 20, 21, 22A-C, and 23A-E. Generally, at least one lance (e.g., spike) may be used to improve stabilization of the implant to the tissue. For example, the lance may inhibit and / or reduce the likelihood of inadvertent movement of the implant (e.g., its anchor receiver) before, during, and / or after fixation. In some implementations where the implant comprises two anchor receivers, the lance may inhibit and / or reduce the likelihood of inadvertent changes in orientation between the two anchor receivers that may otherwise result in undesirable changes in the shape and / or size of the frame.

[0838] Stabilization of the implant in general, and the anchor receiver in particular, relative to tissue may be advantageous during implantation, e.g., prior to and / or during anchoring, and stabilization may advantageously inhibit undesired movement of the implant after implantation, e.g., due to natural heart movement and / or blood flow.

[0839] 20 and 21 are schematic diagrams of an exemplary system 22 (which may be configured for use with, for example, a live subject and / or simulated cardiac tissue) according to some implementations. The system 22 may be used similarly to the systems described above, mutatis mutandis. In some implementations, the system 22 comprises at least one anchor, a delivery tool, and an implant.

[0840] In some implementations, implant 100h or implant 200f may be similar to implants 100 and 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., to be anchored to cardiac tissue to restore the function of the native valve leaflets, except that implants 100h and 200f include a lance attached to the root of the wing, e.g., the anchor receiver. In some implementations, as seen in FIG. 20, a lance 552 is attached to the anchor receiver at the root of implant 100h with a single anchor receiver, while FIG. 21 shows a lance 552 attached to both anchor receivers 350a and 350b of implant 200f. In some implementations, lance 552 is configured to anchor the root of the implant to the tissue, e.g., by driving the lance into the tissue to stabilize the implant against the tissue.

[0841] As shown, the lance 552 may be oriented in various directions. For example, the lance may be aligned with the contact surface of the implant 200f (e.g., along the receiver plane pl1) and / or toward the wall of the heart chamber to improve stabilization of the implant (e.g., as shown for lances 552a, 552b, 552c, 552d, and 552e). Alternatively or additionally, the lance may be oriented to extend away from the contact surface of the implant (e.g., away from the receiver plane pl1 and / or parallel to the anchor that secures the implant), e.g., to project into the same tissue to which the implant is secured (e.g., as shown for lance 552f). The lance 552 may prevent the anchor receiver from moving across the surface of the tissue, may prevent the implant from pivoting about the anchor receiver (e.g., about the axis ax4 of the anchor and / or anchor receiver), and / or may prevent the implant and / or implant receiver from pivoting (e.g., deflection of axis ax4 relative to the surface of the tissue).

[0842] In some implementations, the shaft of the delivery tool can be configured to position implant 100h and / or 200f at a location where the anchor receiver is at a site within the heart, e.g., via engagement with anchor receiver 250 and / or 350. In some implementations, the shaft can be further configured to position the anchor receiver such that at least one of the lances 552 engages tissue in a manner that stabilizes the implant relative to the tissue. For example, at least a portion of at least one of the lances 552 can be inserted into the tissue of the heart to reduce the likelihood of the implant moving along the tissue and / or pivoting around the anchor and / or anchor receiver.

[0843] In some implementations, lance 552 in general, and lance 552f in particular, may be (or may be modified to be) the hollow needle 260 described above, or a variation thereof.

[0844] 22A and 22B are schematic diagrams of example implants 200g and 200h (which may be configured for use in a heart, e.g., a valve of a living subject and / or a simulated heart), according to some implementations. In some implementations, the implants may be considered to be a variation of implant 200f described above, mutatis mutandis, except that implants 200g and 200h may have a different structural design and / or a different manufacturing process. For example, implants 200g and 200h (e.g., their frames and / or anchor receivers) may be cut from a single Nitinol sheet, or any other material having functional properties, such as stainless steel and / or a polymer sheet.

[0845] Additionally, and as shown in FIGS. 22A and 22B, implants 200g and 200h may include three anchor receivers 350, e.g., a central anchor receiver, a first lateral anchor receiver, and a second lateral anchor receiver. In some implementations, one or more of the anchor receivers may have at least one lance disposed on its outer surface, which may perform a similar (e.g., substantially identical) function to lance 552 described above with respect to implant 200f or implant 100h. In some implementations, such implants (e.g., cut from a single sheet) may also be manufactured without a lance. For example, FIG. 22C is a schematic diagram of implant 200i, which may be considered a variation of implants 200g and / or 200h, but lacking any lance.

[0846] In some implementations, what is shown in each of Figures 22A-C represents substantially the entirety of the implant. For example, the frame may not need to be covered with a sheet or braided mesh. In some implementations, what is shown in each of Figures 22A-C represents merely the frame and anchor receiver of the implant, which is intended to be covered with a sheet or braided mesh, for example, as described elsewhere herein, mutatis mutandis.

[0847] The structures and techniques described with respect to Figures 22A-C may alternatively or additionally be applied, mutatis mutandis, to implants that include only a single anchor receiver, such as implant 100.

[0848] In some implementations, the lance may function as a counterforce support, which may be similar, at least in its general function, to one or more of those described in International Patent Application PCT / US2021 / 039587, filed June 29, 2021, by Cau et al., which is incorporated herein by reference. The lance may be configured to engage (e.g., penetrate, press, or abut) the surface tissue and / or walls of the heart to inhibit and / or reduce the likelihood of inadvertently displacing the implant, which may help the implant provide contact pressure and / or support to the native leaflets (e.g., to reduce or eliminate flail, prolapse, stiffness problems, and / or other leaflet abnormalities).

[0849] In some implementations, the orientation of the lance relative to the root and / or anchor receiver may be altered when the shaft disengages the anchor receiver. For example, the lance may have shape memory properties such that when the anchor receiver engages the shaft, the lance may be constrained (e.g., compressed, folded, and / or rolled) for delivery, e.g., along with the implant, to a chamber of the heart.

[0850] In some implementations, the lances may then automatically change their orientation relative to the anchor receiver (e.g., toward a resting state) upon deployment of the anchor receiver at a site within the heart and / or when the shaft disengages from the anchor receiver. Such lances may be made of materials such as, for example, Nitinol, stainless steel, and / or polymers.

[0851] In some implementations, when the shaft engages the root of the wing and / or the anchor receiver, the shaft can apply a force directly to the lance and / or the anchor receiver. The force applied by the shaft can, for example, deform a lance attached to the anchor receiver as long as the force is applied. For example, the lance can be positioned at an angle relative to the receiver plane different from the angle of its rest position as long as the force is applied by the shaft.

[0852] 23A, 23B, 23C, 23D and 23E are schematic diagrams of an exemplary implant 100i (which may be configured for use with a heart, e.g., a valve of a living subject and / or a simulated heart), according to some implementations. The implant may be used with a valve of a heart similar to those of the systems described above, mutatis mutandis.

[0853] The implant 100i includes a lance 522' in the anchor receiver 250 of the implant. FIG. 23A shows the implant 100i in a rest position, with the lance 552' in its rest position. FIG. 23B shows a front view of the implant 100i positioned by the shaft 60 at a site on the valve annulus, with the lance 552' in a transitional deformation position where it can be inserted into the tissue of the annulus and inserted. FIG. 23D shows a side view of the implant 100i positioned by the shaft 60 at a site on the valve annulus, with the lance 552' in a transitional deformation position where it can be inserted into the tissue of the annulus (e.g., at the root of the wing, at a first angle relative to the rest position and / or relative to the plane pl2). The shaft 60 (e.g., its presence and / or the force applied by the shaft) can maintain the lance in this deformation position.

[0854] 23C and 23E show front views of the secured implant 100i. FIG 23C shows the implant 100i secured to tissue with the reoriented lance 552'. This reorientation can be accomplished by removing the shaft 60 so that the lance responsively moves back toward its resting position, e.g., disposed at a second angle relative to the root of the wing and / or relative to the plane pl2.

[0855] FIG. 23E shows implant 100i being secured to tissue by both (i) lance 552′ and (ii) introduction of anchors 30 into anchor receivers. In some implementations, the anchors are introduced before allowing lances 552′ to return to their resting positions. In some implementations, the anchors are introduced afterwards, allowing lances 552′ to return to their resting positions. Thus, while FIGS. 23B-C may be seen as illustrating two steps in a technique for anchoring implant 100i according to some implementations, FIGS. 23D-E may be seen as illustrating two steps in another technique for anchoring implant 100i according to some implementations.

[0856] Implant 100i may be used mutatis mutandis, for example, without and / or with an anchor (such as anchor 30), a delivery tool (such as delivery tool 50), and a catheter as described above. Implant 100i may be similar to implants 100 and 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., to be secured to cardiac tissue to restore the function of native valve leaflets, and except that implant 100i includes a lance that is attached to an anchor receiver.

[0857] In some implementations, the anchor receiver 250 can have a contact surface that defines a receiver plane pl2 and an opposing surface opposite the contact surface. The opposing surface of the anchor receiver can be configured to face a chamber of the heart and to engage with the shaft. The lance 552' has a rest position that can be generally parallel to the receiver plane pl2, such that the lance is biased back to this position. While FIG. 23A shows an example of the lance 552' in a rest position, the plane pl2 is only shown in FIGS. 23B-E. However, engagement between the shaft and the anchor receiver 250 can, for example, transition, e.g., change, the orientation of the lance 552' from their rest position to a deformed position, e.g., such that the lance can protrude past the receiver plane pl2 (FIGS. 23B and 23D). This can facilitate insertion of the lance 552' into the tissue of the heart (e.g., actuation of the lance) upon positioning of the anchor receiver 250 at a site within the heart, e.g., as shown in FIGS. 23B and 23D.

[0858] In some implementations, the shaft 60 can engage with the root of the implant and / or the anchor receiver 250 in a manner that applies a force (e.g., a lateral pushing force) to the lance (e.g., at the root of each lance where the lance is attached to the anchor receiver) such that the end of the shaft is positioned within the anchor receiver in a manner that forces the lance to protrude through the receiver plane pl2, e.g., as shown in FIG. 23B.

[0859] In some implementations, the shaft may be engaged with the root of the implant and / or the anchor receiver in a manner such that an end of the shaft is disposed outside the anchor receiver, e.g., secured to an outer wall of the anchor receiver (e.g., as described in more detail below with respect to FIGS. 26A-27C). In some implementations, a force applied by the shaft to the outer wall of the anchor receiver may deform the lances 552', such as to change their orientation so as to protrude through the receiver plane pl2, as shown in FIG.

[0860] In some implementations, the lances 552' change their orientation relative to the anchor receiver 250 once the shaft is disengaged from the anchor receiver 250 as the lances are biased to move toward the rest position. For example, the lances 552' change their orientation back toward the rest position (FIGS. 23C and 23E). The change in orientation of the lances may strengthen their hold on the tissue and better stabilize the anchor receiver to the tissue. In some implementations, the lances are biased to return their orientation toward the rest position, but because the lances are fixed in the tissue, the tissue may inhibit their return and the lances may not be able to return all the way to their rest position.

[0861] In some implementations, as shown when disposed in its rest position, the lance 552' may be disposed within the anchor receiver. For example, the lance 552' may be surrounded by the anchor receiver.

[0862] It is noted that the scope of the present disclosure includes other lances described herein (including lances disposed along the outer wall of the anchor receiver, such as lance 552 described with reference to Figures 20, 21, 22A, and 22B) that have been modified to function similarly to lance 552', for example, mutatis mutandis, for manipulation by a shaft.

[0863] In some implementations, not illustrated, the lance can have a rest position that is approximately perpendicular to the receiver plane pl2. Thus, when the shaft is engaged with the anchor receiver, the lance changes its orientation to be approximately parallel to the receiver plane pl2. After positioning the anchor receiver at a site within the heart, and when the shaft disengages the anchor receiver, the lance can move back toward its rest position, for example, such that the lance protrudes into the tissue of the heart.

[0864] In some implementations, a lance may be used to stabilize the anchor receiver against tissue, and a driver engaging the anchor may facilitate securing the anchor receiver to the tissue of the heart, which may allow some degree of freedom while securing the anchor receiver to tissue according to in situ conditions such as, for example, the natural movement of the heart, blood pressure, number of anchors requiring anchoring, etc.

[0865] In some implementations in which a hollow needle 260 (described above) is a component of the implant, the hollow needle can also function as a lance to stabilize the implant against the tissue.

[0866] Reference is now made to Figures 24A, 24B, 25A and 25B. In some implementations, the exemplary implant may be indirectly secured to the tissue of the heart, rather than in implementations where the anchor 30 is driven through the anchor receiver of the implant. For example, the anchor receiver may be connected to the anchor by rails 455. In some implementations, implants including wings that may be indirectly secured to tissue are disclosed below. In some implementations, the implant may be considered a variation of implant 200, and may be similar to implant 200 disclosed above, mutatis mutandis, at least in its general purpose, i.e., secured to the tissue of the heart to restore the function of the native leaflets, except that the implants disclosed herein may be slidably secured to the anchors by rails. However, the scope of the present disclosure includes similar variations of implant 100.

[0867] 24A, 24B, 25A and 25B are schematic diagrams of an exemplary implant having wings indirectly secured to heart tissue according to some implementations. In some implementations, the implant may be used in a similar heart valve with an anchor (such as anchor 30), a delivery tool (such as delivery tool 50), a catheter, and the like, mutatis mutandis, to those of the systems described above or below.

[0868] 24A and 24B are schematic diagrams of an exemplary implant 200j that may be considered a variation of implant 200 and may be similar to implants 100 and 200 disclosed above, mutatis mutandis, except that implant 200j includes rails 455 along which its wings are movable that are secured to the tissue of the heart so as to restore the function of the native valve leaflets. In the example shown, the rails are in the form of tethers. However, in some implementations, rails 455 may be wires, rigid rods, or any other form of rails. The implant may be connected to an anchor by rails 455 via an anchor receiver. FIGS. 25A and 25B are schematic diagrams of an exemplary implant 200j' that may be considered a variation of implant 200j, mutatis mutandis, except that implant 200j' includes a slider (e.g., lacing hole) configured to allow the anchor receiver to be easily slidable along rails 455. In some implementations, the implant can be connected to the anchor by a rail via a coupling (eg, a slidable coupling) of the anchor receiver to the anchor.

[0869] In some implementations, the implant 200j may include, among other components, a flexible wing 220, a first anchor receiver 450a and a second anchor receiver 450b coupled to the wing. In some implementations, the anchor receiver 450 may be used to facilitate intracardiac changes (e.g., intracardiac adjustments) of the size and / or shape of the frame 224 and / or the wing 220, as detailed hereinabove. The implant 200j may alternatively or additionally include one or more adjustment elements that may be used to adjust the size and / or shape of the implant, for example, as described above. In some implementations, as illustrated, the longitudinal axis of the rail 455 extending between the anchor receivers defines a movement axis ma1 between the first anchor 30a and the second anchor 30b. In some implementations, the movement axis ma1 defines an axis along which the wing 220 may be moved via movement of the anchor receivers.

[0870] In some implementations, and as shown in FIGS. 24A and 24B, the rail 455 is threaded through the first receiving portion 452a of the first anchor receiver 450a and the second receiving portion 452b of the second anchor receiver 450b, so that the implant 200j is implantable with the wings 220 extending away from the anchor receiver and over the first leaflet toward the opposing leaflet (i.e., the second leaflet) and its contact surface facing the first leaflet. In some implementations, the anchor receiver of the implant is coupled to a slider 454 that is configured to allow the anchor receiver to easily slide along the rail. FIGS. 25A and 25B show an implant 200j' in which the anchor receiver 450 is coupled to the slider. In this example, the rail 455 is threaded between the anchor receiver and the slider.

[0871] As shown, the wing 220 may be moved along the rail and its axis of movement ma1, for example, by sliding the anchor receiver along the rail 455. In some implementations, the ability of the wing to be moved along the axis of movement may provide the implant with an additional degree of freedom, for example, when adjusting the position of the wing over the leaflet.

[0872] In some implementations, where the wings are not fixed directly to tissue, at least along the axis of movement of the implant, the wings may allow for realignment of the wings over the leaflets after implantation of the implant. For example, in some implementations, the wings may remain realignable even months or years after their implantation. In some implementations, the wings may be realigned without extracting and / or repositioning fixation anchors and / or without fastening additional anchors.

[0873] In some implementations, once the wing 220 is in the desired position, the wing is secured to the rail. In some implementations, this securing is achieved by allowing a portion of the anchor receiver to grip the rail, e.g., by being positioned at an angle to the rail, optionally with a high friction side facing the rail (FIG. 24A). Alternatively or additionally, this securing is achieved using one or more stops 460, which may be pre-threaded onto the rail, e.g., pre-secured to the wing or anchor receiver, or as separate components that are movable along the rail independently of the wing (FIGS. 25A-B).

[0874] In some implementations, a stopper may be introduced into the rail within the heart. Additionally or alternatively, in some implementations where sliders are used, at least one of the sliders may comprise or be fixedly attached to a stopper. In some implementations, when sliders that include a stopper are used, the stopper may be in the form of a tightenable screw, clasp, bead, lock, or any other element configured with wings to inhibit unintended movement along the rail.

[0875] In some implementations, the rail may additionally facilitate intracardiac changes (e.g., intracardiac adjustments) of the distance between the first and second anchors to contract or expand the tissue therebetween. For example, if the rail is shorter than the original / resting distance d11, attachment of the end of the rail to the anchor may contract the annulus therebetween. In some implementations, for example, if the rail is stiffer and longer than d11, attachment of the rail to the anchor may expand or stretch the annulus therebetween.

[0876] 24B, the rails 455 are shorter than in FIG. 24A, but the distance (d11) at which the anchors 30 are initially secured to one another is the same. This therefore results in an adjusted distance d12 that is smaller than the distance d11. In some implementations, the rails are fastened to the anchors 30 using fasteners 453, such as beads, locks, clasps, ties, bolts, or any other elements configured to hold the rails 455 fastened to the anchors 30.

[0877] In some implementations, causing deformation of the annulus, e.g., having two points of the annulus compressed toward each other, can help address insufficiency of leaflet coaptation, e.g., can function as an annuloplasty component of the treatment, and / or can further adjust the position of the wing relative to the leaflets of the valve.

[0878] In some implementations, implant 200j and variations thereof may be implantable in a manner such that anchors 30 may first be secured to the tissue of the heart prior to positioning rails 455 and / or wings 220. For example, one or both ends of rails 455 may be connected to the anchors after fixation of the anchors.

[0879] In some implementations, attachment of the rails to one or both of the anchors may be performed after threading the rails through the receiving portion 452 of the anchor receiver 450 or between the receiving portion 452 and a corresponding slider 454, which may be done before withdrawing the wings and rails into the heart chambers.

[0880] In some implementations, all of the components of the implant may be provided pre-connected to one another prior to withdrawing them from the shaft into the heart chambers, for example, anchor 30 may first be connected to rail 455 before being secured to tissue.

[0881] In some implementations, the anchor receiver is configured to be attached to the rail even after the rail has previously been attached to the anchor. For example, the anchor receiver can be designed as a snap hook or carabiner shackle to allow for such implementations.

[0882] 26A, 26B, 26C, 26D, 26E, and 26F. In some implementations, for example, when fixing two or more implants in a proximal position and / or when fixing an implant including two or more anchor receivers, a delivery tool may be used that may include two or more shafts and / or drivers. In some implementations, using multiple shafts and / or drivers introduced simultaneously into a chamber of the heart may allow for better, e.g., more precise intracardiac positioning of the anchor receivers relative to each other and / or a more efficient, e.g., less time-consuming, anchoring procedure. For example, using a delivery tool with two shafts and / or two drivers may allow for a more precise anchoring procedure, e.g., more precise positioning of two or more anchor receivers relative to each other, such as intracardiac setting of the implant wing shape and / or intracardiac positioning of two implants relative to each other. Additionally or alternatively, using two or more shafts and / or drivers may allow for a more rapid anchoring procedure, e.g., because two drivers can fix two anchors simultaneously.

[0883] In general, the system (which may be configured for use with a heart, e.g., a valve of a living subject and / or a simulated heart) may be similar in function to the other systems disclosed above generally, and to systems 20 and / or 20a in particular, mutatis mutandis, except that it comprises two or more shafts and / or drivers for use within the heart, e.g., to deliver an implant to a chamber of the heart and secure it to tissue of the heart. In some implementations, the system may simultaneously use two or more shafts and / or drivers, which may be transluminally advanceable into a chamber of the heart while positioned alongside one another within a delivery tool.

[0884] In some implementations, the delivery tool may include a catheter advanceable transluminally into a chamber of the heart that may facilitate, among other components, two shafts and / or two drivers simultaneously. For example, a first shaft and a second shaft may be positioned alongside one another within the catheter. In some implementations, each shaft may be configured to engage a corresponding anchor receiver and, through engagement with the corresponding anchor receiver, position the implant, for example, at a required location. For example, the shaft may first deploy the implant out of the catheter within the chamber such that the wings may extend away from the anchor receiver.

[0885] In some implementations, once the implant is deployed, for example when the wings are expanded, the shaft can position the implant in a position where the first anchor receiver is at a first location in the heart and the second anchor receiver is at a second location in the heart.

[0886] In some implementations, the implant can be secured (e.g., via positioning of the anchor receiver and anchoring to tissue) so that the wings extend over the first leaflet toward the opposing leaflet (i.e., the second leaflet) and the contact surface faces the first leaflet.

[0887] In some implementations, the flexibility of the anchoring procedure made possible by the simultaneous introduction of two shafts into the heart chambers may allow the implant to be adjusted and secured to tissue within the heart according to in situ requirements such as the natural movement of the heart, blood pressure, etc., which may constantly change.

[0888] 26A, 26B, 26C, 26D, 26E, and 26F are schematic diagrams of an exemplary system 23 (which may be configured to be usable with valves of a heart, e.g., a living subject and / or a simulated heart), according to some implementations. The system 23 is used with a mitral valve 10 of a heart similar to the hear...

Claims

1. A system for use with a heart valve, the valve having a first leaflet and an opposing leaflet, the heart having a chamber upstream of the valve, the system comprising: An implant, an airfoil defining a contact surface and an opposing surface opposing the contact surface, the airfoil comprising a flexible frame; a first anchor receiver and a second anchor receiver, each of the first and second anchor receivers coupled to the wings, the wings extending away from the first and second anchor receivers toward the opposing leaflet and over the first leaflet, and the contact surface facing the first leaflet; and an implant comprising: a first anchor and a second anchor configured to be coupled to the wing via the first and second anchor receivers, the first and second anchors being implantable at a site upstream of the valve and configured to support the implant; A delivery tool comprising: a catheter transluminally advanceable into said chamber; a first shaft and a second shaft disposed parallel to one another within the catheter, each of the first and second shafts comprising: engages a corresponding one of the first and second anchor receivers; receiving a corresponding one of the first and second anchors; a first shaft and a second shaft; First and second anchor drivers, each of the first and second anchor drivers comprising: extending distally within a corresponding one of the first and second shafts; a shaft engaging the corresponding one of the first and second anchors proximal to the corresponding one of the first and second anchors; first and second anchor drivers; a delivery tool comprising: A system comprising:

2. Further comprising a rod, engages the implant; The system of claim 1 , wherein the delivery tool is operable to alter the structure of the implant through engagement with the implant.

3. The system of claim 1, wherein the delivery tool is configured to deliver the implant to the chamber so that the implant extends distally from the first and second shafts within the catheter.

4. The system described in claim 3, wherein the delivery tool is configured to deliver the implant to the chamber so that the wings extend distally from the first and second anchor receivers within the catheter.

5. The first shaft and the second shaft are engaged with the corresponding anchor receivers, deploying the implant out of the catheter within the chamber such that the wings extend away from the first and second anchor receivers; and 2. The system of claim 1, wherein the implant is configured to position the first anchor receiver at a first location of the heart, the second anchor receiver at a second location of the heart, the wings extending over the first leaflet toward the opposing leaflet, and the contact surface facing the first leaflet.

6. The blade has a root portion and a tip portion, 6. The system of claim 5, wherein the implant further comprises legs extending from the tip portions of the wings to end portions of the legs, the legs configured such that contact portions of the legs contact the tissue of the heart downstream of the valve while the implant is fixed in place.

7. The blade has a root portion and a tip portion; 6. The system of claim 5, wherein the implant comprises an attachment element at the tip portion of the wing, the attachment element operable by the delivery tool to attach to a labial edge of the first leaflet.

8. The system described in claim 7, wherein the attachment element comprises a clip attached to the tip portion of the wing, the clip being configured to be attached to the labial edge of the first leaflet by transitioning between an open configuration and a closed configuration while the implant is in the position.

9. The system of claim 5, wherein the delivery tool further comprises a first driver and a second driver, each driver configured to engage with a corresponding one of the first and second anchors and secure the implant in the position by using the first anchor to secure the first anchor receiver to tissue of the heart at the first location and the second anchor to secure the second anchor receiver to tissue at the second location of the heart.

10. The system of claim 9, wherein the delivery tool is configured to simultaneously position the first driver and the second driver within the chamber of the heart.

11. The system of claim 9, wherein the delivery tool further comprises a dry balance configured to stabilize the delivery tool at the tissue.

12. The system of claim 9, wherein the implant further comprises a lance attached to the first anchor receiver and configured to stabilize the implant relative to the tissue.

13. The system described in claim 12, wherein the lance is maintained in a deformed position by engagement between the first shaft and the first anchor receiver.

14. The system described in claim 13, wherein the lance is biased toward a rest position, such that the lance moves toward the rest position in response to disengagement of the first shaft from the first anchor receiver.

15. The system of claim 1, wherein at least one of the implant, the delivery tool, the first anchor, and the second anchor is sterilized.

16. The system described in claim 1, wherein the frame defines an adjustment node connected to a tether extending from the adjustment node to another portion of the wing, such that increasing tension in the tether decreases the distance between the adjustment node and the other portion of the wing.

17. The system of claim 1, wherein the implant further comprises a plurality of barbs extending from the contact surface.

18. The system described in claim 17, wherein the barb is configured to progressively penetrate the first valve leaflet during the course of one or more cardiac cycles of the heart.

19. The system described in claim 17, wherein at least a portion of the barb is sized to penetrate only partway through the first valve leaflet.

20. The system described in claim 17, wherein at least a portion of the barb is sized to completely penetrate the first valve leaflet.

21. The system described in claim 1, wherein the flexibility of the frame allows the distance between the first anchor receiver and the second anchor receiver to be changed within the heart.

22. The system described in claim 21, wherein the distance between the first anchor receiver and the second anchor receiver is changeable within the heart by positioning the first anchor receiver at the first location by the first shaft and by positioning the second anchor receiver at the second location by the second shaft.

23. The system described in claim 22, wherein the distance between the first anchor receiver and the second anchor receiver can be fixed by anchoring the second anchor by the second driver at the second portion of the heart relative to the anchoring of the first anchor at the first portion.

24. The system of claim 1, wherein the implant further comprises an adjustment element extending from the first anchor receiver to the second anchor receiver and configured to facilitate intracardiac change in the distance between the first anchor receiver and the second anchor receiver.

25. The system described in claim 24, wherein the delivery tool further comprises an adjustment actuator configured to adjust the length of the adjustment element.

26. The system described in claim 24, wherein the adjustment element is a compression member.

27. ​​The system described in claim 24, wherein the adjustment element is a tether.

Images