WO2020236417A1

WO2020236417A1 - Expandable anchor for heart valve repair devices

Info

Publication number: WO2020236417A1
Application number: PCT/US2020/030956
Authority: WO
Inventors: Grant Matthew STEARNS
Original assignee: Edwards Lifesciences Corporation
Priority date: 2019-05-22
Filing date: 2020-05-01
Publication date: 2020-11-26

Abstract

In one embodiment, an expandable anchor for use in a heart valve repair device is provided. The expandable anchor includes a mass of one or more expandable materials, such as a hydrogel, disposed within an enclosure. A connecting element connects the expandable anchor to a heart valve repair element. The heart valve repair element can include an element that urges a heart valve leaflet into coaptation with another leaflet, or which provides a surface to improve coaptation with another leaflet. The heart valve repair element can include a remodeling element, which reshapes a portion of the heart, such as a heart chamber, to improve leaflet coaptation. The remodeling element can include an anchor, including another expandable anchor. The enclosure can be delivered to an implantation site in an un¬ expanded state and the mass of one or more expandable materials then expanded to provide a desired degree of anchoring force.

Description

EXPANDABLE ANCHOR FOR HEART VALVE REPAIR DEVICES

FIELD

[001] The present disclosure generally relates to heart valve repair, and more particularly to devices and related methods for improving coaptation between heart valve leaflets.

BACKGROUND

[002] The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the unidirectional flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can result in serious cardiovascular compromise or death.

[003] For many years the definitive treatment for such disorders was the surgical repair or replacement of the valve during open heart surgery. However, such surgeries are highly invasive, and are prone to many complications. Therefore, elderly and frail patients with defective heart valves often went untreated. More recently, transcatheter techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery. Such transcatheter techniques have increased in popularity due to their high success rates.

[004] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The native tricuspid valve connects the right atrium to the right ventricle.

[005] The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets extending downwardly from the annulus into the left ventricle. The mitral valve annulus can form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally“C”- shaped boundary between the abutting free edges of the leaflets when they are closed together.

[006] When operating properly, the leaflets of a heart valve function together to allow blood to flow in a single direction. For example, in the mitral valve, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as“ventricular diastole” or“diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as“ventricular systole” or “systole”), 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 to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords, called chordae tendineae, tether the leaflets to papillary muscles in the left ventricle.

[007] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. There are many different causes of mitral regurgitation. One particular cause is excessive slack in at least one of the native leaflets. This excessive slack prevents the native leaflets from effectively closing during the systolic phase of heart contraction, thus allowing mitral regurgitation. In another case, the heart may have structural defects such that the leaflets are too far apart to provide sufficient coaptation of the leaflets to prevent flow to the left atrium during systole. In another case, the ventricle may be enlarged, pulling the leaflet coaptation edge away from the base too far below the annular plane towards the apex of the heart, preventing proper coaptation of the leaflets. The other native valves of the heart can also suffer from similar conditions that cause regurgitation.

[008] Various devices and methods for treating mitral regurgitation (and other regurgitation of the other native valves) have been developed, including implanting a prosthetic valve within the native mitral valve, surgically removing a portion of the native heart valve leaflets to reduce excessive slack, or clipping or otherwise coupling the leaflets to improve coaptation. In some cases, mitral regurgitation, and other heart conditions, can be treated by remodeling the heart, such as to decrease the size, or alter the shape of, a heart chamber. For example, a structural feature of the heart that can be associated with mitral valve

regurgitation is an increase in the septal-lateral dimension of the mitral annulus. Reducing this dimension can reduce regurgitation. [009] In many cases, implantable devices to treat heart conditions are anchored at a particular location. For example, a device may be anchored to a leaflet of a heart valve. Typical anchors include anchoring elements such as hooks, barbs, or coils, which may be formed from nitinol or another biocompatible material. However, anchors with such anchoring elements can tear out of an attachment location and fail, typically causing an attached heart repair device to cease to function, or at least reducing the effectiveness of the repair device. Thus, there is a continuing need for improved devices and methods for treating heart conditions, such as repairing native heart valve leaflets, including improved anchors for such devices.

SUMMARY

[010] Described herein are embodiments of a device for repairing a heart valve. The device can include an expandable anchor, such as in the form of an enclosure that includes a mass of one or more expandable materials, such as a hydrogel. An expandable material can be selectively expandable, and in some cases contractable, including by exposing the expandable material to a fluid, to a fluid having a suitable temperature, to a fluid having a suitable pH, to electrical stimuli, or to radiation. The enclosure can be configured to be anchored against or at least partially within a surface of the heart. The device can include a connecting element, such as a tether, that connects the enclosure to a heart repair element, such as a coapting element. The coapting element is configured to be positioned with a plurality of native heart valve leaflets.

[011] In some implementations, the connecting element can be configured to support the coapting element at a desired position within the heart valve. For example, the connecting element can be a rod. In a further implementation, an anchor can be coupled to the coapting element and configured to support an upper end of the coapting element.

[012] The enclosure can be made of a mesh material, such as to facilitate the passage of fluid into or out of the enclosure. The enclosure can have a variable-width opening. In some cases, the connecting element is configured to control the width of the variable-width opening.

[013] In another representative embodiment, the enclosure is part of a first anchor and the heart repair element of the device is a second anchor, which can be another expandable anchor as described above. In other implementations, the second anchor can include one or more barbs, hooks, or tines. A connecting element can connect the first anchor and the second anchor. The first and second anchors can be implanted at first anchor and second anchor locations with respect to a heart, and the connecting element placed in tension to draw the first and second anchor locations toward each other.

[014] In a further embodiment, an assembly is provided that includes a catheter, such as a delivery catheter, an anchor catheter, or an implantation catheter, and at least a portion of a heart repair device described above.

[015] In another embodiment, a method for improving coaptation of heart valve leaflets is provided. A first anchor is delivered to a first implantation site in or proximate a heart. The first anchor includes a mass of one or more expandable materials disposed within an enclosure. The mass of one or more expandable materials is expanded to provide a desired anchoring force. A second anchor is delivered to a second implantation site in or proximate the heart. A connecting element connected to the first anchor and to the second anchor is placed in tension to draw the first implantation site and the second implantation site toward each other.

[016] In some cases, the enclosure of the first anchor is a first enclosure and the mass of one or more expandable materials is a first mass of one or more expandable materials. The second anchor can include a second enclosure that includes a second mass of one or more expandable materials. In other cases, the second anchor includes one or more barbs, hooks, or tines.

[017] Suitable implantation sites for the first anchor or the second anchor include beneath the posterior mitral valve leaflet, within the myocardium, within the coronary sinus, within the atrial septum, within the ventricular septum, or against an exterior surface of the heart.

[018] All or a portion of the mass of one or more expandable materials of the first anchor can be present when the enclosure is delivered to the heart, or all or a portion of the mass of one or more expandable materials can be introduced into the enclosure after the enclosure has been delivered to the heart.

[019] According to a further embodiment, a method is provided for implanting a heart repair device. An anchor is delivered to an implantation site in or proximate a heart, such as within the myocardium proximate a lower apex of the heart. The anchor includes a mass of one or more expandable materials disposed within an enclosure. The mass of one or more expandable materials is expanded to provide a desired anchoring force. A coapting element is delivered proximate a heart valve. The coapting element is connected to the anchor by a connecting element. The anchor helps secure the coapting element at a desired implantation location. If desired, one or more additional anchors can be coupled to the coapting element to help secure the coapting element. [020] The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[021] FIG. 1 is a cutaway view of a human heart showing an expandable anchor implanted within the myocardium at the lower apex of the heart using a catheter extending through the tricuspid valve.

[022] FIGS. 2A-2C are detailed views of the delivery and implantation of the expandable anchor of FIG. 1.

[023] FIG. 3 is a cross section of a portion of the right ventricle of the heart, illustrating the deployment of a pair of expandable anchors, where portions of the connecting elements of the expandable anchors pass through a guide tube.

[024] FIG. 4 is a cutaway view of the right side of a heart illustrating an example expandable anchor coupled to a coapting element, where the coapting element is supported within the tricuspid valve by additional stabilizing elements.

[025] FIG. 5 is a cross section of a portion of the left side of the heart, illustrating an example expandable first anchor, disposed within the coronary sinus, connected to a second anchor using a connecting element, where the first anchor, second anchor, and connecting element function as a heart repair device to remodel the left atrium and improve coaptation of the mitral valve leaflets.

[026] FIG. 6 is a cross section of a portion of the left side of the heart, illustrating an example first expandable anchor connected to a second expandable anchor using a connecting element, where the first anchor, second anchor, and connecting element function as a heart repair device to remodel the left ventricle and improve coaptation of the mitral valve leaflets.

[027] FIG. 7 is a cross section of a portion of the left side of the heart, illustrating an example expandable first anchor, placed beneath the posterior mitral valve leaflet, connected to a second anchor using a connecting element, where the first anchor, second anchor, and connecting element function as a heart repair device to remodel the left atrium and improve coaptation of the mitral valve leaflets.

DETAILED DESCRIPTION

[028] Described herein are embodiments of an expandable anchor that can be part of a heart repair device and used to secure a heart repair element of the device. The heart repair device can be primarily intended to be used to improve coaptation of the leaflets of the mitral, aortic, tricuspid, or pulmonary heart valves. Typically, a heart repair device is coupled to a disclosed expandable anchor using a connecting element, such as a tether. In some cases, a heart repair device can be a set of two or more anchors connected by at least one connecting element, where at least one of the anchors is a disclosed expandable anchor.

[029] The expandable anchor can include an expandable material disposed within a flexible enclosure or sack. The flexible enclosure or sack can be fluid-permeable, but configured to retain the expandable material. For example, the flexible enclosure or sack can be a mesh.

[030] The expandable anchor can be coupled to a connecting element. The connecting element can be coupled to the flexible enclosure or sack of the expandable anchor. In other configurations, the connecting element can be secured within the interior of the flexible enclosure or sack. In some cases, the flexible or enclosure or sack can have an opening, such as a variable- sized opening. The connecting element may be secured about the variable-size opening and used to control the size of the opening, such by applying a desired degree of tension to cause the opening to expand or contract. In other cases, the size of the opening can be controlled other than by the connecting element. For example, a separate cord may be disposed about the opening in the flexible enclosure or sack, which can allow the connecting element to be tensioned separately from tension applied to the opening/cord.

[031] Disclosed expandable anchors, and repair elements attached to such anchors, can be introduced into the heart in any suitable manner. In a particular example, an expandable anchor delivery device can access a heart valve, or other portion of a heart, using a transcatheter technique that does not involve a cardiopulmonary bypass machine (referred to as an“off-pump” or a“beating-heart” procedure), or a minimally invasive technique that uses catherization but may include a bypass machine. For example, a delivery device can access the mitral valve using a transcatheter technique to deliver an expandable anchor to the left atrium or left ventricle. Or, a transcatheter technique can be used to deliver an expandable anchor to the right atrium or right ventricle, such as in a procedure to repair the tricuspid valve.

[032] Typically, an expandable anchor is delivered to an anchoring or implantation site.

The expandable anchor may include the expandable material during initial deployment, or the expandable material can be introduced into the enclosure of the expandable anchor after deployment. When the expandable anchor is at the anchoring site, and the expandable material is within the flexible enclosure or sack, the expandable material can be expanded, such as by exposing the expandable material to a fluid or to electrical stimuli or radiation. The expandable material can be expanded to provide a desired degree of anchoring force. In at least some cases, expansion of the expandable material is reversable, such as to facilitate repositioning or removal of the expandable anchor.

[033] Referring first to FIG. 1, a cutaway view of a heart, a catheter 10 is shown inserted through the superior vena cava 12, into the right atrium 14, through the tricuspid valve 16, and into the right ventricle 18 for delivering and implanting an implantable device 6 (FIG. 4). The implantable device 6 includes an expandable anchor 28, which is shown implanted within the myocardium 30 at the lower apex 32 of the heart. The expandable anchor 28 is further described in U.S. Patent Publication No. 2019/0167429, incorporated by reference herein.

[034] With additional reference to FIG. 2A, the implantable device 6 in the illustrated embodiment includes a connecting element 36, which can be a tether, extending from an opening 56 of the expandable anchor 28 and through a lumen 44 of the catheter 10. The opposite end of the connecting element 36 can be coupled to a heart valve repair element, such as a coapting element 70 (described below, FIG. 4).

[035] As shown in FIGS. 1 and 2A, an enclosure 48 of the expandable anchor 28 is disposed at least partially or fully within the myocardium 30. The enclosure 48 can be in the form of a sack or envelope. The connecting element 36 extends from the enclosure 48, through the myocardium 30, into the right ventricle 18, and into the lumen 44 of the catheter 10.

[036] The enclosure 48 of the expandable anchor 28 can contain a mass 52 of an expandable material, such as a swellable material. The enclosure 48 may have an opening 56, which can have a variable-width or variable-diameter. The connecting element 36 can be coupled to the enclosure 48, about the opening 56. As the connecting element 36 is placed under tension, the width of the opening 56 is reduced, in a similar manner as a purse string or drawstring. As described above, in some cases, a separate cord can be placed about the opening 56 and used to adjust the size of the opening. In such cases, the connecting element 36 can be coupled to the enclosure 48 in another manner, such as being tied to material forming the enclosure, being adhered to the enclosure, or being mechanically coupled to the enclosure, such as using a clip or clamp. In some cases, an end of the connecting element 36 can pass into an interior portion of the enclosure 48, and can be secured within such interior portion using a fastener, such as a suture clip, that grips the end of the connecting element, and is sufficiently large to resist passing through the material forming the enclosure. Various suture clips and deployment techniques for suture clips that can be used in the methods disclosed in the present application are disclosed in U.S. Patent Nos. 9,498,202, 8,753,373, and 7,628,797, which are incorporated herein by reference.

[037] The connecting element 36 can be a cord, line, or rail constructed from various materials, including various biocompatible polymers or metals. For example, the connecting element 36 can be a length of suture (e.g., a single filament or multi-filament suture), or can be a wire, rod or cable. The properties of the connecting element 36 can be selected based on a particular heart repair element to be used with an expandable anchor 28. In some embodiments, the connecting element 36 is sufficiently flexible such that it can flex from side to side. In applications where the connecting element 36 is relatively flexible (e.g., the connecting element comprises a suture or cable), the coapting element 70 can include an additional anchor to resist movement of the coapting element toward the anchor 28 (e.g., anchors 74 in FIG. 4). In other applications, it may be desirable for a connecting element 36 to be sufficiently rigid to maintain a heart repair element at a desired position within the heart without additional anchoring at the coapting element 70. In such cases, the connecting element 28 can be a metal or polymeric rod that has sufficient rigidity to resist movement of the coapting element toward the anchor 28. The connecting element 36 desirably is constructed from material that prevents or minimizes longitudinal expansion of the connecting element under tensions that will be applied to the connecting element in use.

[038] Various changes may be made to the expandable anchor 28. For example, the expandable anchor 28 can have an enclosure 48 that does not include an opening 56 (e.g., the expandable anchor has a contiguous surface). In such example, the mass 52 of expandable material may be expanded by fluid permeating through the enclosure 48, or by applying electrical stimuli or radiation. Or, the opening can be of a fixed size. The connecting element 36 can be secured to the enclosure 48 as otherwise described above, including have a connecting element that is secured to material forming the enclosure or which is enclosed within a sleeve formed by such material.

[039] The mass 52 can comprise any suitable expandable material, or a combination of multiple expandable materials, or a combination of one or more expandable materials with one or more non-expandable materials. In some cases, the expandable material can be a polymeric material, such as a hydrogel. Suitable hydrogel materials can include crosslinked carboxymethylated chitosan/poly(ethylene glycol) polymers, lignin hydrogels, and poly (N- isopropylacrylamide) hydrogels. Suitable hydrogels are typically biocompatible and physiologically inert. [040] The mass 52 can be selectively expandable. In some cases, the mass 52 is expanded after the expandable anchor 28 is introduced into, or delivered proximate to, the heart. For example, the mass 52 may be brought in contact with suitable fluids, such as blood, to cause expansion of the mass, and corresponding expansion of the enclosure 48. When contacted with physiological fluids, the amount of material in the mass 52, as well as its expansive properties, are typically selected such that the mass will expand to a desired degree after implantation. That is, the amount of material in the mass 52, its size, and maximum expansion, can be determined prior to implantation, and exposure of the mass to

physiological fluids can cause expansion to such predetermined size.

[041] Fluids used to expand the mass 52 can include externally-introduced fluids, such as fluids introduced through the catheter 10. The mass 52 can include a temperature or pH sensitive material, such as a hydrogel, that expands, and in some cases, contracts, when brought into contact with a fluid having a suitable temperature or pH. The degree of expansion or contraction of the mass 52 can be controlled by the amount of fluid placed in contact with the mass, the amount of time the fluid is kept in contact with the mass, or the temperature or pH of the fluid (e.g., a higher temperature or pH fluid may cause a more rapid expansion, or a greater degree of expansion, than a comparatively lower temperature or pH fluid), or combinations of these factors. The mass 52 may also be expanded, and in some cases, contracted, using other stimuli, such electrical stimuli or radiation (e.g., particular wavelengths of light). Again, the degree (e.g., voltage or current, radiation intensity), duration of exposure, or extent of stimulation can affect how rapidly expansion or contraction of the mass 52 occurs, as well as the degree of expansion or contraction. In some cases, the mass 52 can include materials that are responsive to multiple types of stimulation, including having one type of stimulation used to expand the mass and another type of stimulation used to contract the mass.

[042] As discussed, in at least some cases, the mass 52 can be both expanded and contracted. Having a mass 52 that can be expanded, and then contracted, can provide a number of benefits. For example, during implantation, a physician can expand the mass 52, gauge the anchoring force, and adjust the size of the mass if desired to adjust such anchoring force, but typically otherwise minimizing the size of the mass 52 to avoid disruption to tissue or physiological function. In addition, having a contractable mass 52 can be beneficial if the expandable anchor 28, and optionally an attached heart repair element, is to be removed from the heart. [043] In some cases, the mass 52 can be prepared in a desired shape, such as to conform to native anatomy and provide a desired degree anchoring force, or assist with other

functionality, such as leaflet repositioning. The mass 52 may also be compliant. Having a compliant mass 52 can facilitate conforming the enclosure 48 to native anatomy, as well helping the expandable anchor 28 adapt to anatomical changes that may occur after implantation of the expandable anchor 28. For example, if a higher degree of pressure is placed on the mass 52, the mass may respond by contracting, and spreading laterally.

Correspondingly, if pressure on the mass 52 is reduced, the mass may expand, assuming a more symmetrical shape.

[044] The mass 52 can be a unitary mass of material, such as hydrogel, or can be composed of multiple, discrete particles of the same or varying shapes or sizes, such as multiple hydrogel beads. In some cases, when the mass 52 is formed from multiple particles, the particles need not be joined together. For example, the mass 52 can include multiple hydrogel beads, which can move with respect to one another inside the enclosure 48, but are otherwise contained within the enclosure so as to function similarly to a unitary mass. In other cases, when the mass 52 is formed from multiple particles, the particles can be adhered or otherwise joined together. In some embodiments, the mass 52 is included in the enclosure 48 prior to the expandable anchor 28 being inserted into a patient. In other cases, all or a portion of the mass 52 can be introduced into the enclosure 48 during an implantation procedure, such as after the expandable anchor 28 has been delivered to an anchoring site. In FIG. 2A, the mass 52 is represented by a single particle. However, it should be understood that the enclosure 48 can contain multiple particles of the same or varying sizes.

[045] The enclosure 48 can be fluid-impermeable, in some embodiments, such as when the mass 52 is to be expanded other than through contact with a fluid, or when an amount of fluid is to be retained within the enclosure, thus also contributing to expansion of the expandable anchor 28. In other cases, the enclosure 48 can be permeable, for example, having a mesh structure (e.g., a braided or woven construction) or being constructed from a material that has a desired permeability with respect to a particular fluid. Having a permeable enclosure 48 can be beneficial when physiological fluids, such as blood, are to be used to expand the mass 52, or when external fluids are used to expand the mass, but such fluids are not desired to be retained within the enclosure. The enclosure 48 can be, for example, any biocompatible fabric or another type of biocompatible textile with a desired degree of porosity to a selected fluid. In particular embodiments, the enclosure 48 can be formed from a polyethylene terephthalate (PET) fabric. In alternative embodiments, the enclosure 48 can be formed from a non-textile sheet or membrane formed from a material such as nylon, polyesters, polypropylenes, polytetrafluoroethylene, and expanded polytetrafluoroethylene, and can optionally include apertures or perforations (e.g., formed by laser cutting or by spinning threads of the material into a mesh) with apertures or perforations sized to allow a desired degree of porosity to a selected fluid. In other examples, the enclosure 48 can be formed from braided or woven metal wires or filaments.

[046] If the mass 52 is to be expanded by contact with blood in the heart, the enclosure 48 can be selected to have openings large enough that allow blood in the heart to come into contact with the mass inside the enclosure but small enough to contain the mass or particles that form the mass inside the enclosure. When the enclosure 48 is formed from a woven fabric or a braided material, the weave or braid density can be selected to have openings that perform this particular function.

[047] The enclosure 48 can be expandable to accommodate expansion of the mass 52. In other cases, the enclosure 48 can have an at least substantially fixed interior volume. The enclosure 48 can be constructed with other properties, such as being constructed from a material that encourages tissue ingrowth, such as a PET fabric.

[048] The connecting element 36 can be used to cinch the opening 56 to a desired diameter, which can help retain the mass 52 within the enclosure 48. Having an opening 56 with a variable- width can, among other benefits, allow the enclosure 48 to better adapt to expansion and contraction of the mass 52, such as relieving strain that might be caused by expansion of the mass. The connecting element 36 (or another cord serving the same function) can be coupled to the enclosure 48 by any suitable means, such as being secured within a channel or sleeve formed in the enclosure around the opening 56, or being retained by passing through a plurality of loops coupled to or formed in the enclosure. Or, the connecting element 36 can be threaded through or woven into the material of the enclosure 48, or secured inside the enclosure using a locking member, such as a suture clip

[049] As shown in FIG. 1, the connecting element 36 can pass through myocardium 30 and into the interior of the right ventricle 18. The connecting element 36 can be in the form of an elongated loop, which can extend proximally from the enclosure 48, proximally through the catheter 10, and can have free ends located at or in the vicinity of the proximal end of a delivery apparatus used with the catheter. The free ends of the connecting element 36 can be exposed at the proximal end of the delivery apparatus so that a user can grasp the ends and manually apply force directly to the connecting element to increase the tension in the connecting element and reduce the size of the opening 56, or otherwise tension the connecting element. Alternatively, the free ends of the connecting element 36 can be operatively connected to one or more actuators (e.g., one or more knobs or levers) on a handle of the delivery apparatus, which, when actuated, can increase and decrease the tension in the connecting element to vary the size of the opening 56, or to otherwise tension the connecting element.

[050] In another embodiment, the connecting element 36 can form a loop around the opening 56 and one end (the distal end) of the connecting element can be secured to the enclosure 48, such as by adhering or fastening (e.g., tying a knot) an end of the connecting element to material of the enclosure 48, or to a mounting structure coupled to, or formed on, the enclosure. The connecting element 36 can then extend through the catheter 10, and the opposite end (proximal end) of the connecting element can be exposed at the proximal end of the delivery apparatus for manipulation by a user or can be operatively coupled to an actuator (e.g., a knob or lever) on a handle of the delivery apparatus, which actuator is configured to increase and decrease tension in the connecting element, including to vary the size of the opening 56.

[051] As shown in FIGS. 1 and 2A-2C, the enclosure 48 of the expandable anchor 28 is fully disposed within the myocardium 30. In other examples, the expandable anchor 28 can be partially disposed within the myocardium 30, or other tissue. Typically, when an expandable anchor 28 is partially disposed within the myocardium 30, a widest portion of the enclosure 48 is disposed within the myocardium, which helps maintain the position of the expandable anchor/resist pullout forces. As will be further described, an expandable anchor 28 may be secured other than by being retained within tissue. For example, the expandable anchor 28 can abut a surface of the heart, such as the surface of a leaflet, a surface of the interatrial septum or the ventricular septum, or an outer surface of the heart, or can be retained within a structure proximate the heart, such as a blood vessel, for instance, the coronary sinus.

[052] FIGS. 2A-2C illustrate a method for delivering an expandable anchor 28 to the heart, and securing the expandable anchor in position. As shown in FIG. 2A, the expandable anchor 28 can be delivered through the catheter 10, which acts as a sheath for the enclosure 48. The catheter 10 can help maintain the enclosure 48 in a collapsed state to facilitate delivery. FIG. 2A illustrates the enclosure 48 as including the mass 52 of expandable material, but with the mass being in an unexpanded, or less expanded, state. FIG. 2A illustrates the catheter 10 having its tip 60 within the myocardium 30, at the implantation site. The tip 60 of the catheter 10 can be sharp, or fitted with a needle, in order to assist inserting the tip into the myocardium 30.

[053] The catheter 10 can include a steering mechanism to facilitate delivery of the expandable anchor 28 to an implantation site. For example, the catheter 10 can have a steering mechanism (e.g., a pull wire and a corresponding adjustment mechanism on a handle of the catheter) to steer or adjust the curvature of the distal end portion of the catheter. For example, the curvature of the distal end portion of the catheter 10 extends towards the desired implantation site. Further details regarding the construction of a steerable catheter are disclosed in U.S. Patent No. 10,076,638, which is incorporated herein by reference.

[054] FIG. 2B illustrates the expandable anchor 28 being expanded, such as by contacting the mass of expandable material 52 with a fluid introduced from the tip 60 of the catheter 10 into an interior volume of the enclosure 48 through the opening 56. The opening 56 can have a comparatively large size to facilitate fluid delivery. The majority of the enclosure 48 is shown removed from the tip 60 of the catheter 10, such as by slightly retracting the catheter in the direction shown. The opening 56 of the enclosure 48 remains within, or is in contact with, the tip 60 of the catheter 10 in the illustrated example. In other implementations, other methods can be used to expand the mass 52 of expandable material, such as expanding the mass through contact with a physiological fluid (e.g., blood) or applying suitable electrical stimuli or radiation. Compared with FIG. 2A, the mass 52 has a larger size, and causes the enclosure 48 to correspondingly expand.

[055] FIG. 2C (and FIG. 1) illustrates the expandable anchor 28 in a deployed, fully expanded state. Once the mass 52 of expandable material has been expanded to a desired degree, the catheter 10 can be removed from the implantation site, leaving the expandable anchor 28 in place. As the expandable anchor 28 is larger than any remaining opening (i.e., through which the connecting element 36 extends) in the myocardium 30, which opening typically will be greatly reduced in size due to resilience of the surrounding tissue, the expandable anchor resists movement when the connecting element is placed under tension.

[056] Expanding the mass 52 of expandable material to a desired degree to achieve the state shown in FIG. 2C can include adjusting the size of the expanded expandable anchor 28 by expanding the mass 52 and then reducing the size of the mass if the anchor is determined to be too large. The size of the expandable anchor 28 can be adjusted through a series of expansion and/or contraction steps in order to achieve the desired size/anchoring force.

[057] Once the expandable anchor 28 has been expanded to a desired size, the size of the opening 56 can be reduced, such as by applying tension to the connecting element 36, helping maintain the mass 52 within the enclosure 48. A free end of the connecting element 36 (distal to the expandable anchor 28) can be pulled to apply the tension. Once the opening 56 has reached a desired size, and the connecting element 36 is otherwise suitably tensioned, the free end of the connecting element 36 can be secured to maintain the desired tension. For example, the connecting element 36 can be secured under the desired degree of tension to a heart repair element positioned at the free end of the connecting element.

[058] Although FIGS. 1 and 2A-2C show a single expandable anchor 28 being used, a plurality of expandable anchors can be used as part of a heart repair device. Or, a plurality of expandable anchors 28 coupled by one or more connecting elements 36 can function as a heart repair device, such as to reposition a heart structure, such as a valve leaflet (e.g., to improve leaflet coaptation), or to remodel the heart, such as to adjust the shape of the heart to improve coaptation of valve leaflets. Among other things, multiple expandable anchors 28 can be used to provide a stronger anchoring force for an attached heart repair element (which could be an anchor, including being another expandable anchor).

[059] FIG. 3 is a cross section of a portion of a heart illustrating a pair of expandable anchors 28, each having a separate connecting element 36. Unlike the embodiment shown in FIGS. 1 and 2A-2C, in FIG. 3, the anchors 28 are shown as partially embedded in the myocardium 30. The connecting elements 36 can be retained within the lumen of a guide tube 66, which can help maintain the connecting elements at a desired position. Retaining the connecting elements 36 at a desired position can, for example, reduce the chance of the connecting elements 36 becoming entangled with other heart structures, such as the chordae tendineae. The connecting elements 36 may be coupled to the same heart repair element or mechanism, or to different heart repair elements or mechanisms, which repair elements or mechanisms are not shown in FIG. 3.

[060] When multiple expandable anchors 28 are used with a single heart repair element, the multiple anchors can help provide additional anchor strength and resistance to pull out compared with using a single anchor. Similarly, when connecting elements 36 are used to provide positional or structural support for a repair element, such as maintaining the element at a desired position, the use of multiple connecting elements and/or expandable anchors 28 can provide a higher degree of support compared with using a single anchor, and can provide support from multiple directions, which can also help maintain a heart repair element at a desired position. In cases where it may be beneficial to support a heart repair element from multiple directions, or multiple heart repair elements are used, and are implanted at different locations, the guide tube 66 can be omitted, or multiple guide tubes can be included, such as having a guide tube for each group of one or more connecting elements 36 proximate a particular location.

[061] FIG. 4 is a cutaway view of a heart, showing an expandable anchor 28 in use with a heart repair element in the form of a coapting element or spacer 70. The coapting element 70 can be a heart repair element disclosed in U.S. Patent Nos. 9,474,605 or 9,636,223, each of which is incorporated by reference herein. The connecting element 36 of the expandable anchor 28 is connected to the coapting element 70. As noted above, the connecting element 36 in some embodiments can be sufficiently rigid, such as being formed from a metal rod, to support the coapting element 70 in an implantation location, such as between the native leaflets of the tricuspid valve 16 and prevent migration of the coapting element toward the anchor 28 into the right ventricle without any additional anchors. Although shown in use with the tricuspid valve 16, the coapting element 70 can also be used with the mitral valve.

[062] In one embodiment, the heart repair device 6 can be implanted in a patient by first delivering the expandable anchor 28 via the catheter 10 of FIG. 1, which can be referred to as an anchor catheter. The expandable anchor 28 can be expanded as shown in FIGS. 2A-2C. The anchor catheter 10 can then be removed from the patient. The coapting element 70 can be delivered using a delivery catheter 72, guided over the connecting element 36, to a desired position within the tricuspid valve 16. In the illustrated embodiment, the coapting element 70 is connected to the distal end of the delivery catheter 72. The position of the coapting element 70 along the length of the connecting element 36 can then be fixed, such as with a locking member, for example a locking collet, that secures a section of the delivery catheter 72 to the connecting element. The portion of the delivery catheter 72 and the connecting element 36 proximal to the locking member can be severed. The locking member and the portion of the delivery catheter 72 and the connecting element 36 extending distally from the locking member can remain inside the body and can be sutured or otherwise secured in place, such as to subcutaneous tissue outside the subclavian vein. Further details regarding the coapting element, the delivery catheter, the locking member, and methods for implanting these components are described in detail in U.S. Patent Nos. 9,474,605 or 9,636,223, each of which is incorporated by reference herein.

[063] However, the heart repair device 6, or another heart repair device using an expandable anchor 28, can be implanted within a patient using various other techniques and delivery devices. In an alternative embodiment, for example, the anchor 28 can be delivered and implanted using catheter 10 as described above. The coapting element 70 can then be delivered over the connecting element 36 using a separate delivery catheter with the coapting element 70 releasably connected to a distal end portion of the delivery catheter. The delivery catheter is used to position the coapting element 70 between the native leaflets of the valve (e.g., the tricuspid valve, as described above) and the position of the coapting element relative to the connecting element 36 is fixed, such as by actuating a locking member (e.g., a locking collet) on the coapting element. The delivery catheter can then be released from the coapting element 70 and removed from the patient’s body. The portion of the connecting element 36 proximal to the coapting element 70 can be severed and removed from the patient’s body.

[064] In another embodiment, the coapting element 70 and the expandable anchor 28, connected using the connecting element 36, can be assembled to form the implantable device 6 prior to implantation and delivered to the right side of the heart as a single unit, such as using the same delivery catheter (e.g., catheter 10). In particular embodiments, for example, the implantable device 6 is mounted on a distal end portion of a shaft of the delivery catheter. The delivery catheter can include an outer sheath that extends over the shaft and the implantable device 6 as the implantable device is advanced through the patient’s vasculature. The expandable anchor 28 can be deployed from the sheath and implanted first (e.g., in the manner described above), followed by deployment of the coapting element 70 from the sheath. Thereafter, the delivery catheter can be removed from the patient’s body.

[065] In some cases, and as shown in FIG. 4, additional anchors 74 can be used to secure the coapting element 70 in a desired position. In addition to the expandable anchor 28, which is longitudinally spaced with respect to the coapting element 70, the additional anchors 74 are laterally spaced with respect to the coapting element 70, and can help maintain the coapting element at a desired lateral position within the tricuspid valve 16. The additional anchors 74 can also provide additional resistance to longitudinal movement or migration of the coapting element 70, such as if the connecting element 36 is formed from relatively flexible material, such as a suture or cord. The anchors 74 can be coupled to the coapting element 70, or to the delivery catheter 72 (if the distal end portion of the catheter is left in the patient’s body), by stabilizing elements 78.

[066] The coapting element 70 can be configured to improve coaptation of heart valve leaflets. For example, in the event that heart valve leaflets do not properly coapt during systole to prevent regurgitation through the tricuspid valve 16, the coapting element 70 serves as a spacer that provides a coaptation surface for the leaflets of the tricuspid valve. That is, during diastole, when the tricuspid valve 16 is open, the leaflets of the tricuspid valve can be removed from contact with the coapting element 70 such that blood can flow from the right atrium 14 into the left ventricle 18. During systole, when then tricuspid valve 16 closes, the leaflets of the tricuspid valve can coapt against the coapting element 70, thus preventing or minimizing blood from regurgitating through the tricuspid valve from the right ventricle into the right atrium.

[067] As shown, the additional anchors 74 can include a plurality of circumferentially extending fastening or anchoring elements, such as hooks, barbs, or tines. Each additional anchor 74 can be coupled to the coapting element 70 (or the catheter 72) by a stabilizing element 78, such as a rod, cable, or wire. The fastening elements of the additional anchors 74 can pierce the tissue of the annulus of the tricuspid valve 16, securing the stabilizing element to the valve, and thereby helping maintain the coapting element 70 within the opening of the tricuspid valve, at a desired lateral and longitudinal position.

[068] In an alternative embodiment, one or both of the additional anchors 74 can be an expandable anchor 28 deployed at least partially in adjacent tissue of the heart. Alternatively, where one or both anchors 74 are replaced with expandable anchor(s) 28, the expandable anchor(s) 28 can be deployed at least partially in tissue of the heart at respective locations in the sub-annular gutter of the tricuspid valve 16 (where the anchor(s) 28 can contact inferior surfaces of respective leaflets), securing the stabilizing elements 78. However, the expandable anchors 28 can be secured in other manners, such as placing an expandable anchor against an exterior portion of the myocardium (e.g., against the outer surface of the heart), placing an expandable anchor in the left side of the heart (e.g., in the left atrium, proximate the inter-atrial septum), or in the left ventricle 22, proximate the ventricular septum.

[069] If the securing force provided by the additional anchors 74 is sufficiently strong, the expandable anchor 28 disposed at the apex 32 of the heart can be omitted. Although shown in use with a coapting element 70 in the form of a spacer, an expandable anchor 28 can be used with other types of heart repair elements or mechanisms, including other types of devices that provide, or augment, a coaptation surface, devices that improve leaflet coaptation, such as leaflet clips, or devices that urge leaflets into better position for coaptation, such as devices that can be placed underneath a leaflet or which alter the dimensions of the heart about a valve in order to better position the leaflets to coapt with one another.

[070] While FIG. 4 illustrated an expandable anchor 28 in use with a coapting element 70 that provides a coaptation surface, FIGS. 5-7 illustrate how an expandable anchor 28 coupled to another anchor by a connecting element 36 form a heart repair device, such as to remodel the heart to improve leaflet coaptation. FIG. 5 illustrates a remodeling device comprising an expandable anchor 28 coupled by a connecting element 36 to a second anchor 82. The expandable anchor 28 is disposed with the coronary sinus 84 (for simplicity of presentation, the boundary between the heart wall and the coronary sinus is not shown). The enclosure 48 of the expandable anchor 28 abuts a lateral wall of the coronary sinus 84, providing an anchoring force. The second anchor 82 is shown in the right atrium 14, abutting the interatrial septum 86. The second anchor 82 is shown as a mechanical anchor, attaching to the tissue of the interatrial septum 86 by one or more fastening elements, such as described for the additional anchors 74 of FIG. 4. Alternatively, the second anchor 82 can be anchored onto the septum 86 within the left atrium 20. By placing the connecting element 36 under a desired amount of tension, the cross-sectional dimension of the left atrium 20 and the mitral valve 92 can be reduced, which can improve coaptation between the anterior leaflet 88 and the posterior leaflet 90 of the mitral valve.

[071] Various changes can be made to the remodeling scenario shown in FIG. 5. For example, the securement locations of the expandable anchor 28 and the second anchor 82 can be switched. If desired, the second anchor 82 can be an expandable anchor 28 instead of an anchor having anchoring elements such as barbs, hooks, or tines.

[072] FIG. 6 illustrates a heart repair device, and in particular a remodeling device, comprising a pair of expandable anchors 28a, 28b, connected by a common connecting element 36, being used to reduce the cross-sectional diameter of the left ventricle 22. A first expandable anchor 28a can be disposed in the right ventricle 18, such as abutting the ventricular septum 96. The connecting element 36 extends laterally across the left ventricle 22 to a second expandable anchor 28b disclosed against the exterior of the myocardium 30. Although shown as a pair of expandable anchors 28a, 28b, another type of anchor, such as an anchor having anchoring elements such as hooks, barbs, or tines, could be used in place of one of the expandable anchors. In addition, although shown as adjacent the ventricular septum 96, the expandable anchor 28a could instead be located fully or partially within the tissue of the ventricular septum. Similarly, the expandable anchor 28b could be located fully or partially within the myocardium 30, rather than abutting the myocardium.

[073] Tension in the connecting element 36 can be increased as previously described with respect to the embodiments of FIGS. 1-5 to bring the outer wall of the left ventricle 20 closer to the septum 96 to improve function of the left ventricle. In some applications, the remodeling device can be implanted within or adjacent the sub-annular gutter of the mitral valve such that tensioning of the connecting element 36 is effective to remodel the mitral valve and improve coaptation of the native leaflets 88, 90. The remodeling device altematively can be implanted at similar locations on the right side of the heart to remodel the right ventricle and/or the tricuspid valve.

[074] FIG. 7 illustrates a heart repair device 98 that includes a first expandable anchor 28 and a second anchor 82. The second anchor 82 can be placed in the right atrium 14, against the interatrial septum 86. The second anchor 82 can be as described with respect to the embodiment of FIG. 5, including, in a particular example, also being an expandable anchor. The expandable anchor 28 is disposed against the inferior surface 102 of the posterior mitral valve leaflet 90.

[075] A connecting element 36 connects the expandable anchor 28 and the second anchor 82. The connecting element 36 can be placed under tension, thus drawing the posterior leaflet 90 superiorly and anteriorly, improving coaptation with the anterior mitral valve leaflet 88, which can reduce regurgitation through the mitral valve 92. Including the expandable anchor 28 underneath the posterior mitral valve leaflet 90 can be beneficial, as it can help lift the leaflet when expanded, in addition to reducing the distance between the leaflet and the interatrial septum 86 and the anterior leaflet 88.

[076] As described with respect to FIG. 5, various changes may be made to the

embodiment shown in FIG. 7. For example, if the second anchor 82 is an expandable anchor, the expandable anchor 28 can be replaced with a different type of anchor, such as an anchor that includes hooks, barbs, or tines. The second anchor 82 also can have various other configurations as disclosed in U.S. Patent Publication No. 2017/0340443, which is incorporated herein by reference.

[077] Expandable anchors 28 can provide a number of advantages. For example, when an expandable anchor is implanted at least partially within tissue, by being implantable in a compressed or un-expanded state, an incision or hole used to insert an expandable anchor 28 can be comparatively small. The expandable anchor 28 can be expanded after implantation to provide a desired degree of anchoring force.

[078] The degree of swelling of the expandable anchor 28 can depend on the compliance of the tissue in which the expandable anchor is implanted, and can automatically adjust to provide an anchoring force. For instance, it would be expected that, in more compliant tissue, more swelling of the expandable anchor 28 would be needed to provide a desired anchoring force. However, as the tissue is more compliant, the expandable anchor 28 will naturally swell to a larger degree than if implanted in less compliant tissue. Correspondingly, less expansion would be expected to be needed to achieve an equivalent anchoring force when the expandable anchor 28 is implanted in less compliant tissue. Since the tissue is less compliant, the expandable anchor 28 will naturally expand to a smaller degree. As the degree of swelling is naturally correlated with the compliance of the tissue in which the expandable anchor 28 is implanted, the chances of tissue damage being caused by swelling of the expandable anchor can be reduced. The expandable anchors 28 thus self-adapt to their implantation environment, compared with other anchoring methods, such as hooks or barbs, that function the same way regardless of the nature of the tissue in which they are implanted.

[079] The ability to have the desired degree of expansion with a reduced- size incision or hole can further reduce tissue damage compared with other anchoring methods. However, the ability to expand the expandable anchor 28 can allow for higher tensions to be used compared with other anchoring mechanisms.

[080] Other methods of anchoring heart repair devices, or elements of such devices, such as the use of anchors having anchoring elements such as hooks, barbs, or tines, can be difficult to remove without damaging tissue at the implantation site. At least certain disclosed expandable anchors 28 can be shrunk after being expanded at an implantation site. Shrinking an expandable anchor 28 can reduce tissue damage associated with removing the anchor. Similarly, the ability to shrink an expandable anchor 28 can facilitate repositioning of the expandable anchor, and adjustment of the size of the anchor to provide a desired anchoring force.

[081] Repair devices using the expandable anchor 28 described herein have been described in the context of improving the function of a tricuspid or mitral valve, such as by improving leaflet coaptation. The expandable anchors 28 can generally be used with repair devices for repairing native heart valves, or artificial heart valves or artificial heart valve components (e.g., artificial leaflets), including using various transcatheter techniques (e.g., transatrial, trans ventricular, etc.).

[082] A variety of methods can be used to deliver an expandable anchor 28 to an implantation location. For example, when used to provide anchoring in, or proximate to, the left atrium or the left ventricle, a trans-septal delivery technique can be used to deliver an expandable anchor, and other components of a heart repair device, through a patient’ s vasculature where a delivery apparatus can be inserted through a femoral vein and the vena cava to the right side of the heart in an antegrade direction and then through the atrial septum to access the left side of the heart.

[083] Alternatively, in a transfemoral procedure, a delivery device for an expandable anchor 28 and/or other components of an implantable device can be inserted through a femoral artery and the aorta to the heart in a retrograde direction. Alternatively, a delivery apparatus for an expandable anchor 28 and/or other components of an implantable device can be inserted through a femoral vein and the vena cava to the right side of the heart in an antegrade direction, such as for delivering an expandable anchor to an implantation site proximate the tricuspid valve.

[084] In a transventricular procedure, a delivery apparatus for an expandable anchor 28 and/or other components of an implantable device can be inserted through a surgical incision made in the chest and at a location on the left or right ventricle to access implantation locations proximate valves on the left and right sides of the heart. For example, the delivery apparatus can be inserted through an incision made on the bare spot on the lower anterior ventricle wall to access implantation locations proximate the left ventricle. Similarly, the delivery apparatus for an expandable anchor 28 and/or other components of an implantable device can be inserted through a surgical incision on the wall of the right ventricle to access implantation locations proximate the pulmonary or tricuspid valves. In a transatrial procedure, the delivery apparatus can be inserted through a surgical incision made in the wall of the left or right atrium to access the native valves on the left or right sides, respectively, of the heart. In a transaortic procedure, the delivery apparatus can be inserted through a surgical incision made in the ascending aorta and advanced toward the heart. Further details of delivery techniques for accessing the native valves of the heart are disclosed in U.S. Patent No. 9,414,918, which is incorporated herein by reference.

[085] It should be noted that the positioning of the disclosed expandable anchor 28, and heart repair devices used therewith, can be confirmed visually using imaging modalities such as fluoroscopy, X-ray, CT, and MR imaging. Echocardiography in either 2D or 3D can also be used to help guide the positioning of the expandable anchor 28.

General Considerations

[086] For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another.

The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present, or problems be solved.

[087] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The present disclosure is not restricted to the details of any foregoing embodiments. The present disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[088] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods.

[089] As used herein, the terms“a”,“an” and“at least one” encompass one or more of the specified element. That is, if two of a particular element are present, one of these elements is also present and thus“an” element is present. The terms“a plurality of’ and“plural” mean two or more of the specified element.

[090] As used herein, the term“and/or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase“A, B, and/or C” means“A,”“B,”“C,”“A and B,”“A and C,”“B and C” or“A, B and C.”

[091] As used herein, the term“coupled” generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.

[092] As used herein, the term“proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term“distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device toward the user, while distal motion of the device is motion of the device away from the user. The terms“longitudinal” and“axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined. [093] As used herein, the terms“integrally formed” and“unitary construction” refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[094] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. I therefore claim as my invention all that comes within the scope and spirit of these claims.

Claims

What is claimed is:

1. A device for repairing a heart valve, the device comprising:

an enclosure comprising a mass of one or more expandable materials and configured to be anchored against or at least partially within a surface of the heart;

a coapting element configured to be positioned between a plurality of native heart valve leaflets; and

a connecting element coupled to the enclosure and the coapting element.

2. The device of claim 1, wherein the mass of one or more expandable materials comprises a hydrogel.

3. The device of any previous claim, wherein the connecting element comprises a tether.

4. The device of any previous claim, further comprising an anchor coupled to the coapting element and configured to support an upper end of the coapting element.

5. The device of any previous claim, wherein the connecting element is configured to support the coapting element at a desired position with respect to the heart valve.

6. The device of any previous claim, wherein the connecting element comprises a rod.

7. The device of any previous claim, wherein the enclosure is made from a mesh material.

8. The device of any previous claim, wherein the enclosure comprises a variable- width opening.

9. The device of claim 8, wherein the connecting element is configured to control a width of the variable-width opening.

10. A heart remodeling device comprising:

a first anchor, the first anchor comprising an enclosure comprising a mass of one or more expandable materials and configured to be anchored at a first location with respect to a heart;

a second anchor configured to be anchored at a second location with respect to the heart; and

a connecting element connecting, and extending between, the first anchor and the second anchor.

11. The device of claim 10, wherein the mass of one or more expandable materials is a first mass of one or more expandable materials and the enclosure is a first enclosure, and the second anchor comprises a second enclosure comprising a second mass of one or more expandable materials.

12. The device of claim 10, wherein the mass of one or more expandable materials comprises a hydrogel.

13. The device of any of claims 10-12, wherein the second anchor comprises one or more barbs, hooks, or tines.

14. The device of any of claims 10-13, wherein the connecting element is configured to be placed in tension to draw the first and second locations of the heart toward each other.

15. An assembly comprising:

a catheter; and

the heart repair device of any previous claim.

16. A method for improving coaptation of heart valve leaflets, the method comprising: delivering a first anchor to a first implantation site in or proximate a heart, the first anchor comprising a mass of one or more expandable materials disposed within an enclosure; expanding the mass of one or more expandable materials to provide a desired anchoring force;

delivering a second anchor to a second implantation site in or proximate the heart; and placing a connecting element connected to the first anchor and the second anchor in tension to draw the first implantation site and the second implantation site toward each other.

17. The method of claim 16, wherein the mass of one or more expandable materials is a first mass of one or more expandable materials and the enclosure is a first enclosure, and the second anchor comprises a second mass of one or more expandable materials disposed within a second enclosure.

18. The method of claim 16 or claim 17, wherein the first implantation site or the second implantation site is beneath the posterior mitral valve leaflet.

19. The method of any of claims 16-18, wherein the first implantation site or the second implantation site is within the myocardium.

20. The method of any of claims 16-19, wherein the first implantation site or the second implantation site is within the coronary sinus.

21. The method of any of claims 16-20, wherein the first implantation site or the second implantation site is against an exterior surface of the heart.

22. The method of any of claims 16-21, wherein the first implantation site or the second implantation site is within the atrial septum or the ventricular septum.

23. The method of any of claims 16-22, wherein delivering a first anchor to an implantation site comprises:

delivering the enclosure to the implantation site; and

delivering at least a portion of the mass of one or more expandable materials to the enclosure while the enclosure is at the implantation site.

24. A method for implanting a heart repair device, the method comprising:

delivering an anchor to an implantation site in or proximate a heart, the anchor comprising a mass of one or more expandable materials disposed within an enclosure;

expanding the mass of one or more expandable materials to provide a desired anchoring force; and delivering a coapting element to a location between the native leaflets of a heart valve, wherein the coapting element is connected to the anchor by a connecting element.

25. The method of claim 24, wherein the implantation site is within the myocardium proximate a lower apex of the heart.

26. The method of claim 24 or claim 25, further comprising one or more additional anchors coupled to the coapting element.