Atrioventricular regurgitation solutions

Abstract

Devices and methods for reducing atrioventricular heart valve regurgitation. Some implementations include a compressible and expandable spacer with a proximal end and a distal end and sized to fit within and to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween. The spacer has a compressed delivery configuration and a radially expanded implant configuration. Supra-annular anchoring arms connect to the proximal end of the spacer via a malleable central mount extending axially from the spacer. The anchoring arms extend outward from a proximal end of the central mount sufficiently far to reach the atrioventricular annulus. Each anchoring arm terminates in a tissue anchor, wherein the central mount has one or more plastically- deformable components such that a position of the spacer relative to the atrioventricular annulus may be adjusted from leaflet contact therewith.

Description

ATRIOVENTRICULAR REGURGITATION SOLUTIONSRELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Patent Application No. 63 / 645,582, filed May 10, 2024, the contents of which are expressly incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure relates generally to devices and methods for reducing atrioventricular heart valve regurgitation.BACKGROUND

[0003] Heart valve disease, such as valve regurgitation, is typically treated by replacing or repairing the diseased valve during open-heart surgery. However, open-heart surgery is highly invasive and is therefore not an option for many patients. For high-risk patients, a less- invasive method for repair of heart valves is considered generally advantageous. In patients with severe / torrential tricuspid valve regurgitation, the tricuspid valve annulus and the right ventricle are often seen to have dilated abnormally large amounts, often times resulting in a severe loss of tricuspid valve leaflet coaptation.

[0004] One solution is seen in the FORMA Transcatheter Tricuspid Repair System from Edwards Lifesciences, Inc. of Irvine, CA, as well as solutions disclosed in U.S. Patent No. 9,474,605 and WO2022 / 164557A1, both expressly incorporated herein, which introduce a gapfilling element into the tricuspid valve that restores leaflet coaptation, reduces tricuspid regurgitation (TR) and right atrium (RA) pressure, and thereby alleviates classic TR patient symptoms and improves quality of life. In one solution, a flexible rail having a ventricular anchor on the distal end thereof adapted to anchor into tissue within a ventricle is first deployed percutaneously. A repair catheter passes along the flexible rail, and a leaflet coaptation member or spacer on a distal end of the catheter is located within the native valve leaflets. When in place, the spacer fills gaps between the tricuspid leaflets and reduces or eliminates regurgitationthrough the native valve. Various alternative anchoring techniques include deployment of the anchor trans-pcricardial (through the base of the RV and through the pericardium) and transseptal (through the interventricular septum from the RV through to the LV). Both US 9,474,605 and WO2022 / 164557A1 document alternative anchoring techniques and are expressly incorporated herein.

[0005] Despite these and other cardiac implants anchored in subvalvular spaces, the task of successfully and consistently reducing regurgitation, especially while the heart is beating, remains difficult and requires improvements.SUMMARY

[0001] The present invention relates generally to devices and methods for reducing atrioventricular’ heart valve regurgitation, meaning through either the tricuspid or mitral valves.

[0002] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a compressible and expandable spacer. The compressible and expandable spacer can include a proximal end and a distal end. The compressible and expandable spacer can be sized to fit within and coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween. In some implementations, the spacer has a compressed delivery configuration. In some implementations, the spacer has a radially expanded implant configuration.

[0003] In some implementations, the device can include supra-annular anchoring arms. The supra-annular anchoring arms can connect to the spacer. In some instances, the anchoring arms can connect to the proximal end of the spacer. In some implementations, the supra-annular anchoring aims a e connected to the spacer via a malleable central mount extending axially from the spacer. The anchoring arms extend outward from the central mount.

[0004] In some implementations, the anchoring arms extend from a proximal end of the central mount to the atrioventricular annulus. The anchoring arms can terminate in a tissue anchor. In some implementations, the central mount has one or more plastically-deformable components. The one or more plastically-deformable components can permit the position of the spacer relative to the atrioventricular annulus to be adjusted from leaflet contact therewith.

[0005] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes an adjustable spacer. The adjustable spacer can have a proximal endand a distal end. The adjustable spacer can be sized to fit within the leaflets of an atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer having a compressed delivery configuration and a radially expanded implant configuration.

[0006] In some implementations, the system device, and / or apparatus can include a central mount. The central mount can be a malleable central mount that extends axially from the spacer, e.g., from a proximal end of the spacer. In some implementations, the system device, and / or apparatus can include supra-annular anchoring arms coupled to the central mount. In some implementations, each supra-annular anchoring arm comprising a tissue anchor. In some implementations, the central mount includes one or more plastically-deformable components. The one or more plastically-deformable components can allow a position of the spacer relative to the atrioventricular annulus to be adjusted from leaflet contact.

[0007] In some implementations, a heart valve system, device, and / or apparatus is adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween. The atrioventricular valve can have an annulus and leaflets extending inward therefrom.

[0008] In some implementations, the heart valve system, device, and / or apparatus comprises a compressible and expandable spacer. The compressible and / or expandable spacer can have a proximal end and a distal end. The compressible and / or expandable spacer can be sized to fit within the leaflets of the atrioventricular valve. The compressible and / or expandable spacer can be configured to coapt against the leaflets to reduce regurgitation therebetween. The spacer can have a compressed delivery configuration and a radially expanded implant configuration.

[0009] In some implementations, the heart valve system, device, and / or apparatus includes supra-annular anchoring arms connected to the proximal end of the spacer by a central mount. The central mount can be a malleable central mount. The central mount can extend axially from the spacer. In some implementations, the anchoring arms are generally evenly distributed around and extending outward from a proximal end of the central mount. The anchoring arms can extend sufficiently far to reach the atrioventricular annulus. Each anchoring arm can terminate in a tissue anchor.

[0010] In some implementations, the central mount has one or more plastically-deformable components such that a position of the spacer relative to the valve annulus may be adjusted from leaflet contact therewith.

[0011] In some implementations, the tissue anchor may be selected from one or more of corkscrew-type anchors, barbs and clips. In some implementations, there may be four generally evenly distributed anchoring arms. In some implementations, The plastically-deformable components of the central mount may comprise a coiled neck.

[0012] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes an adjustable spacer. The adjustable spacer can be a compressible and expandable spacer. The spacer can have a proximal end and a distal end. The spacer can be sized to fit within the leaflets of the atrioventricular' valve and configured to coapt against the leaflets to reduce regurgitation therebetween. The spacer having a compressed delivery configuration and a radially expanded implant configuration.

[0013] In some implementations, the a system, device, and / or apparatus can include supraannular anchoring frame. The frame can have an inner ring attached to a proximal end of the spacer . The frame can have an outer ring connected to the inner ring. The inner and outer rings can be connected via a plurality of radial struts. The inner and outer rings along with the plurality of radial struts can define a plurality of spaces therebetween.

[0014] In some implementations, the outer ring is sized to be in contact with the atrioventricular annulus. In some implementations, the outer ring is coupled to a plurality of tissue anchors. In some implementations, the frame further has a porous mesh or net that extends across a portion but not all of the spaces between the radial struts.

[0015] In some implementations, each tissue anchor may be selected from a group consisting of corkscrew-type anchors, barbs and clips. In some implementations, each tissue anchor may pass through a grommet or cleat fixed to the outer ring. In some implementations, the inner ring and outer ring may be circular. In some implementations, the inner ring may be a separate component from the spacer and attached to the spacer in vivo. In some implementations, the porous mesh or net may extend between each of the radial struts near an outer periphery of the spaces adjacent the outer ring in polygonal segments.

[0016] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes an adjustable spacer having a proximal end and a distal end. The adjustable spacer can be sized to fit within leaflets of an atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer has a compressed delivery configuration and a radially expanded implant configuration.

[0017] In some implementations, the system, device, and / or apparatus includes a supraannular anchoring frame. The frame can include an inner ring. The inner ring can be attached to a proximal end of the spacer. The frame can include an outer ring. The outer ring can be sized to be in contact with the atrioventricular annulus. The frame can include a plurality of radial struts connecting the inner ring and the outer ring, the plurality of radial struts having spaces defined therebetween. In some implementations, the system, device, and / or apparatus includes a plurality of tissue anchors coupled to the outer ring. In some implementations, a porous mesh or net extends across a portion but not all of the spaces between the radial struts.

[0018] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes an adjustable spacer. The adjustable spacer can be a compressible and expandable spacer. The spacer can have a proximal end and a distal end and be sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer has a compressed delivery configuration and a radially expanded implant configuration.

[0019] In some implementations, the system, device, and / or apparatus includes a supraannular winding or reel mechanism. The winding or reel mechanism can be provided on the spacer. The winding or reel mechanism can be coupled to a plurality of tethers. The plurality of tethers may be adjustable.

[0020] In some implementations, a plurality of tissue anchors are each connected to an outer end of one of the tethers. In some implementations, the tissue anchor may be selected from a group consisting of corkscrew-type anchors, barbs and clips. In some implementations, the winding or reel mechanism may be remotely controlled.

[0021] In some implementations, each tissue anchor may have magnetic properties and the tethers connect to the tissue anchors using a magnetic cap on the end of each tether. A length of each tether may be separately controlled with the winding or reel mechanism.

[0022] In some implementations, a method of deploying the device includes steering a guidewire through vasculature and through the target annulus, advancing a delivery sheath to a location in the atrium adjacent the target annulus, pre-installing the tissue anchors around the target annulus, advancing the spacer into position within the valve leaflets, and attaching the tethers to the tissue anchors.

[0023] In some implementations, the method can include using fluoroscopy, echocardiography, ultrasound, or an imaging camera to observe an amount of regurgitation through the target annulus, and adjusting the tethers until a desired reduction in regurgitation is observed.

[0024] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a spacer. The spacer can be defined by a generally tubular wall having a hollow interior and a generally cylindrical exterior sized. The spacer can be sized to fit within leaflets of an atrioventricular valve. The spacer can be configured to coapt against the leaflets to reduce regurgitation therebetween.

[0025] In some implementations, the system, device, and / or apparatus includes supra-annular anchoring arms. The anchoring arms can be formed of flexible bars. The anchoring arms can each include an outer length connected to the proximal end of the spacer wall and an inner end bent 180° and attached to a control disk. A movable shaft can be attached to the control disk. In some implementations, the movable shaft has a central throughbore sized to travel over a central rod. The central rod can extend distally into the spacer interior such that the shaft and control disk may be displaced into the spacer interior. In some implementations, distal displacement of the shaft and control disk causes each anchoring arm to buckle and bend outward in a midsection and extend outward a distance sufficient to reach the target annulus.

[0026] In some implementations, a plurality of tissue anchors are each connected to an outer extent of the mid-section of one of the anchoring arms. In some implementations, further distaldisplacement of the shaft and control disk into the spacer interior causes the outer extent of the mid-section of the anchoring arms to retract radially.

[0027] In some implementations, each tissue anchor may be selected from a group consisting of corkscrew-type anchors, barbs and clips. The anchoring arms may be formed of Nitinol.

[0028] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a spacer. In some implementations, the spacer can be a compressible and expandable spacer. In some implementations, the spacer has a proximal end and a distal end. In some implementations, the spacer is sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer has a compressed delivery configuration and a radially expanded implant configuration.

[0029] In some implementations, the system, device, and / or apparatus includes a control shaft. The control shaft can be coupled to an upper control disk. In some implementations, the control shaft includes a lumen. The lumen can be sized to travel over a concentric inner control tube. The concentric inner control tube can terminate in a lower control disk. In some implementations, the control shaft and inner control tube are aligned with a central axis of the spacer.

[0030] In some implementations, the system, device, and / or apparatus includes a plurality of supra- annular flexible anchoring arms. The anchoring arms can be distributed around the proximal end of the spacer. In some implementations, Distal end portions of the anchoring arms connect to the lower control disk. In some implementations, proximal end portions of the anchoring arms connect to the upper control disk. In some implementations, proximal displacement of the control shaft and upper control disk relative to the lower control disk lengthens and radially constricts the anchoring arms into a delivery configuration. In some implementations, distal displacement of the control shaft and upper control disk relative to the lower control disk causes mid- sections of the anchoring arms to buckle and bend outward into a pyramidal configuration such that the mid-sections extend outward a distance sufficient to reach the annulus.

[0031] In some implementations, the system, device, and / or apparatus includes a plurality of tissue anchors. The plurality of tissue anchors are each connected to an outer extent of the midsection of one of the anchoring arms. In some implementations, further distal displacement of the control shaft and upper control disk relative to the lower control disk causes the outer extent of the mid- section of the anchoring arms to retract radially.

[0032] In some implementations, the upper control disk, anchoring arms and lower control disk may be formed of a single-piece element. In some implementations, the single-piece element may be formed by a single tube of Nitinol which is laser cut to form the upper control disk, anchoring arms and lower control disk. In some implementations, there may be exactly four anchoring arms.

[0033] In some implementations, the device may further include a mechanism for advancing the tissue anchors into the tissue. In some implementations, the mechanism for advancing the tissue anchors into the tissue can include actuating rods extending along each of the anchoring arms. The actuating rods can cooperate via elements extending through the control shaft with an exterior control handle.

[0034] In some implementations, each of the anchoring arms may have an outer bifurcated portion in the mid-section which forms an aperture through which an associated tissue anchor projects, and an outer end of an actuating rod engages each tissue anchor.

[0035] In some implementations, each tissue anchor may be a corkscrew-type anchor. In some implementations, the actuating rods are configured to rotate about their own axes to deploy the tissue anchors.

[0036] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a mesh-like member formed of flexible connected filaments or struts. The mesh-like member may comprise a generally tubular shape that radially expands when compressed and radially contracts when elongated. The mesh-like member comprises a proximal end portion opposite a distal end portion.

[0037] In some implementations the system, device, and / or apparatus includes a spacer. The spacer can comprise defined a flexible fabric or bioprosthetic skirt attached to the mesh-like member. In some implementations, the flexible fabric can form a generally tubular wall having ahollow interior and a generally cylindrical exterior. The spacer can be sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer includes a resilient inner ring. The resilient inner ring can be disposed near the proximal end portion.

[0038] In some implementations the system, device, and / or apparatus includes a delivery tube. The delivery tube can comprise a lumen within which the radially contracted mesh-like member and spacer can be received. In some implementations, the proximal end portion and distal end portion of the mesh-like member arc displaced apart while inside the delivery tube. In some implementations, the delivery tube is attached to the proximal end portion of the mesh-like member.

[0039] In some implementations the system, device, and / or apparatus includes an inner control shaft that extends through the delivery tube and through the inner lumen. The control shaft can be attached to the distal end of the mesh-like member. In some implementations, the inner control shaft is movable relative to the delivery tube such that a distance between the proximal end and distal end of the mesh-like member may be adjusted.

[0040] In some implementations, distal displacement of the delivery tube relative to the inner control shaft causes the proximal end of the mesh-like member to advance toward the distal end of the mesh-like member. Responsive to this movement a proximal portion of the mesh-like member can expand and splay radially outward to form a supra-annular flange. In some implementations, the diameter of the supra-annular flange is sufficient to reach the annulus.

[0001] In some implementations the system, device, and / or apparatus includes a plurality of tissue anchors. In some implementations, each tissue anchor engages the supra-annular flange and embeds in annulus tissue to anchor the supra-annular flange thereto.

[0042] In some implementations, further distal movement of the delivery tube relative to the inner control shaft causes an outer periphery of the supra-annular flange to retract radially. This retraction of the supra-annular flange can cause decrease the size of the annulus to reduce regurgitation.

[0043] In some implementations, each tissue anchor may be selected from a group consisting of corkscrew-type anchors, barbs and clips. In some implementations, the relative positions ofthe distal and proximal ends of the mesh-like member may be fixed by detaching a distal tip of the delivery tube and affixing the distal tip relative to the inner control shaft.

[0044] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween.

[0045] In some implementations the system, device, and / or apparatus includes a hollow axial post through which passes a fixation bolt having a cylindrical slider affixed to a distal end thereof. In some implementations, a housing connects to the proximal end of the spacer, the housing having an inner cavity and a proximal throughbore through which the fixation bolt passes to accommodate relative lateral movement of the bolt. In some implementations, wherein the cylindrical slider is held within the inner cavity and also has room for relative lateral movement therein.

[0046] In some implementations the system, device, and / or apparatus includes a plurality of support arms connect to and extend outward from the post. In some implementations, the plurality of support arms terminate in tissue anchors for securing to the annulus. In this manner, the device may be anchored to the annulus using the tissue anchors with the spacer suspended between the leaflets. In some implementations, the spacer is laterally movable by forces exerted by the leaflets.

[0047] In some implementations, the device includes a lock nut at the distal end of the fixation bolt. Tightening the lock nut can fix the lateral position of the slider within the cavity of the housing.

[0048] In some implementations, the fixation bolt may have a faceted proximal end exposed on the proximal end of the axial post for tightening the lock nut. In some implementations, the device may prevent the spacer from moving in the atrium-ventricular axis but allow complete freedom to move along lateral axes. In some implementations, at least some of the support arms may be articulated with locking pivots along their lengths that permit additional range of movement of the spacer.

[0049] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes an axial post having a proximal hub. In some implementations the system, device, and / or apparatus includes a spacer having a proximal end and a distal end is sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer has an outer generally tubular wall connected to the post via a pair of flexible membranes that extend across proximal and distal ends of an inner cavity of the spacer in order to provide a seal across the ends irrespective of the relative lateral positions of the spacer and post.

[0050] In some implementations the system, device, and / or apparatus includes a plurality of support arms connected to and extending outward from the hub. In some implementations the plurality of support arms can terminate in tissue anchors for securing to the annulus. In this manner, the device may be anchored to the annulus using the tissue anchors with the spacer suspended between the leaflets and being laterally movable by forces exerted by the leaflets.

[0051] In some implementations, the membranes may be corrugated or pleated to allow stretching on one side and compression on another side of the post. In some implementations, the tubular wall may have an outwardly -bulged portion at its midplane formed by an outer skin covering a compressible inner material. In some implementations, the compressible inner material may be foam.

[0052] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a proximal hub. In some implementations the system, device, and / or apparatus includes a malleable spacer. The spacer can have a proximal end connected to the hub and a distal end sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween.

[0053] In some implementations, The spacer has an expanding or weakly-expanding frame. In some implementations, the spacer includes a pouch. The expanding frame can provide inner support to the pouch. In some implementations, the pouch is made at least partly of a permeable fabric. The permeable fabric can allows passage of cells and liquid. In some implementations, the expanding frame biases the spacer to expand. The spacer can expand by being filling with blood through the permeable fabric. In some implementations, the permeable fabric is configured to prevent passage of clots.

[0054] In some implementations the system, device, and / or apparatus includes a plurality of support arms connected to and extending at an angle from the hub. The plurality of support arms can terminate in tissue anchors for securing to the annulus. In this manner, the device may be anchored to the annulus using the tissue anchors with the spacer suspended between the leaflets. In some implementations, the spacer can be laterally movable by forces exerted by the leaflets. In some implementations, the pouch may be primarily impermeable, with a window of permeable fabric.

[0055] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a generally cylindrical spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween.

[0056] In some implementations, the spacer includes a hollow bushing. In some implementations the spacer includes a dynamic skirt. The dynamic skirt can surround the bushing. The dynamic skirt can have an open distal end and a closed proximal end.

[0057] In some implementations the system, device, and / or apparatus includes an anchoring rail. In some implementations the anchoring rail is a ventricular anchoring rail. In some implementations, the anchoring rail is slidingly received within the bushing. The anchoring rail can have a length sufficient to extend from the spacer when positioned at the atrioventricular valve, and terminate in a tissue anchor for anchoring in ventricular tissue.

[0058] In some implementations the system, device, and / or apparatus includes an atrial anchoring assembly. The atrial anchoring assembly can include a hub. In some implementations, the hub attaches to the bushing. In some implementations, the atrial anchoring assembly includes a rigid crossbeam. The rigid crossbeam can be attached to and extend radially outward in opposite directions from the hub. In some implementations, the rigid crossbeam is at each opposite end to a mid-portion of a flexible lateral beam. In some implementations, the atrial anchoring assembly includes atrial tissue anchors at the terminal ends of each lateral beam for anchoring into tissue at the annulus. In some implementations, the device may be anchored at the annulus using the atrial tissue anchors with the spacer suspended between the leaflets. The spacer can be axially movable by blood flowing in and out to alternately inflate and deflate the dynamic skirt.

[0059] In some implementations, the lateral beams may be pivotally connected to the opposite ends of the crossbeam. The lateral beams can have lengths sufficient to anchor on opposite sides of commissures of the atrioventricular valve. The lateral beams may be made of a flexible polymer or a fabric.

[0060] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a generally cylindrical spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer has a hollow interior having an opening to permit inflation with blood.

[0061] In some implementations, the system, device, and / or apparatus includes an atrial anchoring assembly. The atrial anchoring assembly can include a rigid linkage member. The rigid linkage member can be pivotally attached to a proximal end of the spacer.

[0062] In some implementations, the atrial anchoring assembly can include a rigid crossbeam pivotally attached at a mid-portion of the linkage member. In some implementations, the atrial anchoring assembly can include a pair of flexible lateral beams connected to opposite ends of the crossbeam. In some implementations, the atrial anchoring assembly can include atrial tissue anchors at the terminal ends of each lateral beam for anchoring into tissue at the annulus.

[0063] In some implementations, the device can be anchored at the annulus using the atrial tissue anchors with the spacer suspended between the leaflets. The device can be alternately inflated and deflated by blood flowing in and out of the spacer and movable within the annulus due to the pivoting connections.

[0064] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a generally spherical spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween. In some implementations, the spacer has an inner collapsible and expandable structure including a plurality of connected walls defining a plurality of open cells. The open cells can be surrounded by a biocompatible cover which allows blood to pass through and enter the cells.

[0065] In some implementations a system, device, and / or apparatus for delivering a device to within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween. The atrioventricular valve can have an annulus and leaflets extending inward therefrom, and ventricular chordae extending from the leaflets to a ventricular wall.

[0066] In some implementations, the system, device, and / or apparatus comprises a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular valve. In some implementations, the system, device, and / or apparatus comprises generally cylindrical spacer radially compressible to enable passage though the access sheath. The spacer can be configured to expand when outside the access sheath and coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween. In some implementations, the spacer has a central throughbore. In some implementations, the spacer includes a plurality of dogleg guides fixed to a distal end of the central thoroughbore and extending radially outward.

[0067] In some implementations, the system, device, and / or apparatus comprises a plurality of flexible anchor legs. The anchor legs can collectively attach to a plunger. The plunger can be arranged to move axially in the throughbore of the spacer. In some implementations, each ventricular anchor leg is constrained to pass through one of the dogleg guides.

[0068] In some implementations, the system, device, and / or apparatus comprises a control rod extends proximally through the access sheath and attached to displace the plunger. In some implementations, wherein the anchor legs may be deployed to the underside of the leaflets, e.g., in a subannular groove. The anchor legs can be deployed by advancing the control rod once the spacer is positioned by the access sheath at the annulus.

[0069] In some implementations, each dogleg guide may define an arc of approximately 150- 180°. In some implementations, each ventricular anchor leg may terminate in a rounded or bulbous end, and may be covered in fabric. In some implementations, each dogleg guide may commence with a curled tubular segment that terminates at an outlet pointed in a proximal direction, and each ventricular anchor leg may be a wire that passes through the curled tubular segment and continues in a loop and returns to be secured within a grommet or crimp at a distal end of the curled tubular segment, wherein displacement of the ventricular anchor leg changes the size of the loop.

[0070] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular valve. In some implementations, the system, device, and / or apparatus can include a generally cylindrical spacer. The spacer can be radially compressible to enable passage though the access sheath and be configured to expand when outside the access sheath. The spacer can be configured to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween.

[0071] In some implementations, the system, device, and / or apparatus can include a plurality of flexible anchor legs that are movable axially from within a throughbore in the spacer to a position extending out of a distal end thereof. In some implementations, the plurality of anchor legs are constrained together in a narrow delivery configuration by a primary cinch.

[0072] In some implementations, each ventricular anchor leg extends distally in a first section and has a terminal end bent in a proximal direction and held inward aligned with the first section by secondary cinches. In some implementations, removal of the primary cinch permits the plurality of ventricular anchor legs to radially separate and removal of the secondary cinches permits the terminal ends to separate from the first sections.

[0073] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular valve. In some implementations, the system, device, and / or apparatus can include a generally cylindrical spacer. The spacer can be radially compressible to enable passage though the access sheath and configured to expand when outside the access sheath. The spacer can be configured to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween.

[0074] In some implementations, the system, device, and / or apparatus can include a plurality of flexible anchor legs to collectively attach to a plunger and arranged to move axially in the throughbore of the spacer to a position extending out of a distal end thereof. In some implementations, each anchor leg extends distally in a first section and has a terminal end bent in a proximal direction and constrained when in the throughbore.

[0075] In some implementations, the system, device, and / or apparatus can include a pusher that extends proximally through the access sheath and attaches to displace the plunger. In some implementations, the anchor legs may be expelled from the throughbore by advancing the pusher and plunger once the spacer is positioned by the access sheath at the annulus to permit the terminal ends to expand radially away from the first sections.

[0076] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a control shaft having a length sufficient to extend from outside the body to the atrioventricular valve. In some implementations, the system, device, and / or apparatus can include a generally cylindrical spacer attaches at a distal end of the control shaft and is sized to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween.

[0077] hi some implementations, the spacer has a plurality of arcuate ventricular grasping legs projecting outward therefrom. The grasping legs can be convertible between a delivery position and a deployed position where pairs of grasping legs combined to capture one or more ventricular chordae. In some implementations, the grasping legs may convert between the delivery position and the deployed position by rotation or extension and actuated by the control shaft. In some implementations, the grasping legs may convert between the delivery position and the deployed position in conjunction with the spacer changing shape from a generally circular cross-section to an elongated or more elliptical cross-section.

[0078] In some implementations, the system, device, and / or apparatus can include a mechanism within the spacer including two racks arranged to move away from one another when actuated by the control shaft, the racks each engaging pinion gears connected to the grasping legs to rotate the grasping legs when the racks move away from one another.

[0079] In some implementations a system, device, and / or apparatus for reducing heart valve regurgitation includes a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular’ valve. In some implementations, the system, device, and / or apparatus can include a generally cylindrical spacer at a distal end of the access sheath. The spacer is configured to expand and coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween.

[0080] In some implementations, the spacer has an internal blood pump system comprising a rigid inner tube surrounded by an inflatable outer skin connected thereto. The innertube defines an inner chamber that receives a plunger that may be displaced axially via the access sheath. In some implementations, the inner tube also has an inlet valve open to an external environment and an outlet valve open to a space between the inner tube and the outer skin. In some implementations, reciprocating movement of the plunger alternately opens and closes the valves to pull blood in through the inlet valve and transfer it to the space to inflate the spacer.

[0081] In some implementations, a plurality of supra-annular anchoring arms connect to and extend outward at an angle from a proximal end of the spacer such that the device may be anchored to the annulus with the spacer suspended between the leaflets. In some implementations, the plunger can be rigidly connected to a threaded actuator at a proximal end of the spacer which may be engaged via the access sheath to axially displace the plunger. In some implementations, the system can include a fluid conduit extending through the access sheath and open to the space, wherein saline may be injected or removed through the fluid conduit to test the efficacy of the spacer in reducing regurgitation.

[0082] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0083] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0084] A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.BRIEF DESCRIPTION OF THE DRAWINGS

[0085] To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to variousaspects of the appended drawings. It is appreciated that these drawings depict some implementations of the present disclosure and arc therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures may be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments of the present disclosure will be described and explained with additional specificity and detail using the accompanying drawings.

[0086] Figure 1 is a schematic illustration of a human body showing a femoral access path for a delivery sheath for placing a regurgitation reduction spacer and associated atrial anchors at the tricuspid valve, with an enlarged view of the heart in section;

[0087] Figure 2 is an enlarged sectional view of the right side of the heart illustrating an array of both sub- and supra-annular anchors distributed around a regurgitation reduction spacer as disclosed in the prior ail;

[0088] Figures 3A and 3B are enlarged views of the right side of the heart in section illustrating a regurgitation reduction spacer positioned between tricuspid valve leaflets and having supra-annular anchoring arms and a malleable central mount;

[0089] Figure 3C is an enlargement of the end of one of the supra-annular anchoring arms of Figure 3A;

[0090] Figure 4A is an enlarged supra-annular view of a proximal end of the spacer of Figures 3A and 3B showing the central mount immediately post-implant, and Figure 4B is the same view showing the central mount having been deflected after a period of time in the body;

[0091] Figure 5 A is a supra-annular view of a proximal end of an alternative spacer of the present application anchored at the tricuspid annulus, and Figure 5B is a partial sectional view thereof;

[0092] Figures 6A-6C are sectional views showing several steps in the deployment of supra-annular anchors of another spacer of the present application, and Figure 6D is a perspective view of the spacer implanted at the tricuspid annulus;

[0093] Figures 7A and 8A are perspective and sectional views of another spacer assembly with supra-annular anchors in a first step of deployment;

[0094] Figures 7B and 8B show the spacer of Figures 7A and 8A with the supra-annular anchors radially extended to anchor at the tricuspid annulus;

[0095] Figures 7C and 8C show the spacer of Figures 7A and 8A with the supra-annular anchors radially retracted to pull the tricuspid annulus inward towards the spacer;

[0096] Figure 9A is a supra-annular perspective of a further spacer and anchoring assembly prior to deployment;

[0097] Figures 9B and 9C are sectional views showing two steps in deployment of the spacer and anchoring assembly of Figure 9A;

[0098] Figures 10A-10C are detailed views of the spacer and anchoring assembly of Figure 9A;

[0099] Figure 10D is a perspective view of a single -piece element forming flexible anchoring arms and control discs for the spacer and anchoring assembly of Figure 9A;

[0100] Figures 11A and 12A arc perspective and sectional views of another spacer and supra-annular anchor assembly in a first step of deployment;

[0101] Figures 11B and 12B show the assembly of Figures 11A and 12A with the anchor apparatus radially extended to the tricuspid annulus;

[0102] Figures 11C and 12C show the assembly of Figures 11A and 12A with the anchor apparatus radially retracted to pull the tricuspid annulus inward towards the spacer;

[0103] Figure 13 A is a supra-annular perspective of a still further spacer and supra- annular anchoring assembly after deployment, and Figure 13B is a sectional view thereof illustrating a range of lateral movement of the spacer;

[0104] Figures 14A and 14B are sectional views of the spacer and anchoring assembly of Figures 13A and 13B showing a range of motion post- implant prior to fixation;

[0105] Figure 15 is a top plan view of the tricuspid annulus showing the spacer and anchoring assembly of Figures 13A and 13B after fixation;

[0106] Figure 16A is a supra-annular perspective of a still further spacer and supra- annular anchoring assembly after deployment, and Figure 16B is a sectional view thereof illustrating a range of lateral movement of the spacer;

[0107] Figure 17 is a sectional view through a malleable spacer having supra-annular anchors;

[0108] Figures 18A and 18B are plan views of the tricuspid annulus showing sectional views of the malleable spacer of Figure 17 before and after a shape change thereof;

[0109] Figure 19 is an enlarged sectional view of the right side of the heart showing one exemplary spacer of the prior art having a ventricular anchor;

[0110] Figure 20 is an enlarged sectional view of the right side of the heart showing a spacer of the present application with both supra- and sub-annular anchors;

[0111] Figures 21A and 21B are schematic perspective views of the spacer of Figure 20 during a diastolic phase of the cardiac cycle;

[0112] Figures 22A and 22B are schematic perspective views of the spacer of Figure 20 during a systolic phase of the cardiac cycle;

[0113] Figures 23A and 23B are schematic perspective views of an alternative spacer similar to that in Figure 20 in both diastolic and systolic phases, respectively;

[0114] Figures 24A and 24B arc sectional views through an atrioventricular annulus schematically illustrating how sub-annular anchors of a regurgitation reduction spacer are deployed using techniques of the prior art, and Figure 25 is a perspective view of the spacer and sub-annular anchors after implant;

[0115] Figures 26 A and 26B are sectional views through an atrioventricular annulus schematically illustrating deployment of sub-annular anchors from a spacer of the present application;

[0116] Figures 27A-27C are perspective views of three alternative anchor guides that may be used in the spacer system shown in Figures 26A and 26B;

[0117] Figures 28A-28C are sectional views through an atrioventricular schematically illustrating deployment of a further sub-annular anchoring system of the present application;

[0118] Figures 29A-29C are sectional views through the atrioventricular annulus schematically illustrating deployment of a still further sub-annular anchoring system of the present application;

[0119] Figures 30A and 30B are perspective views of the atrioventricular annulus illustrating two steps in deployment of a sub-annular anchoring system for a spacer of the present application, Figures 31A and 3 IB are sectional views thereof, and Figures 32A and 32B are schematic plan views thereof;

[0120] Figures 33A and 33B are schematic plan views of an alternative sub-annular anchoring system utilizing chordae capturing legs in two stages;

[0121] Figures 34A and 34B are sectional views through an atrioventricular annulus illustrating two stages in deployment of a spacer having chordae capturing legs;

[0122] Figures 35A and 35B are schematic plan views of the spacer of Figures 34A and 34B before and after capturing chordae, and Figures 36A and 36B are schematic sectional views thereof;

[0123] Figure 37 is an enlarged sectional view of the right side of the heart showing a still further exemplary spherical spacer having supra-annular anchoring aims;

[0124] Figure 38 is a partially cutaway view of the spherical spacer in an expanded configuration;

[0125] Figures 39A-39C schematically illustrates three steps in expansion or deployment of the spherical spacer;

[0126] Figure 40 is an enlarged sectional view of the right side of the heart showing deployment of an inflatable spherical spacer having supra-annular anchoring arms;

[0127] Figures 41A and 41B are sectional views through the spacer of Figure 40 showing an internal blood pump system for inflating the spacer;

[0128] Figure 42 is an enlarged sectional view of the right side of the heart showing deployment of another inflatable spacer having supra-annular anchoring arms; and

[0129] Figures 43A and 43B are sectional views through the spacer of Figure 42 showing an internal blood pump system for inflating the spacer as well as a supplemental inflation lumen.DETAILED DESCRIPTION

[0130] The following description refers to the accompanying drawings, which illustrate specific implementations. Other implementations having different structures and operation do not depart from the scope of the present disclosure.

[0131] The techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representationsof body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (c.g., if they arc just demonstrating in the air on an imaginary heart, etc.)

[0132] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0133] The present application discloses systems and methods for anchoring cardiac implants, in particular as illustrated a heart valve regurgitation reduction spacer within an atrioventricular' hear! valve. Such heart valve regurgitation reduction systems may be implanted within the left or right side of the heart and may extend out of the heart into the vasculature, for example, to the subclavian vein. However, the principles disclosed herein for anchoring such an implanted device are suitable for other applications as well. The present application relates generally to devices and methods for reducing atrioventricular heart valve regurgitation, meaning through either the tricuspid or mitral valves.

[0134] Materials used for the various implantable structures include biocompatible metals, polymers, and even bioprosthetic tissue, such as for example the exterior of regurgitation reduction spacers with which the valve leaflets coapt. Highly flexible elements may be Nitinol or other super-elastic alloy, while compressible elements may be soft polymers or the like. The material of any one element is typically dictated by its functional properties - i.e., rigidity, strength, expandability, etc., and should not otherwise be considered limited.

[0135] Figure 1 is a schematic illustration of a human body showing a delivery sheath 20 inserted along a femoral access path in the process of placing a regurgitation reduction spacer and associated atrial anchors at the tricuspid valve, in accordance with various implementations described herein. The sheath 20 is percutaneously placed within the femoral vein through a small incision 22 in the upper leg using the so-called Seidinger technique. In this process, the physician accesses and then punctures a desired vessel or cavity with a sharp hollow needle, and advances a round-tipped guidewire through the lumen of the needle. The needle is withdrawn, and a sheath or blunt cannula can now be passed over the guidewire into the cavity or vessel. The process may also include insertion and subsequent removal of one or more obturators over the guidewire to define gradually increasing diameter access holes into the vessel.

[0136] With reference to the enlarged view of the heart in section, a distal end 24 of the sheath 20 emerges from the inferior vena cava IVC within the right atrium RA and adjacent to the tricuspid valve TV. As will be understood by those of skill in the art, the access pathway to the right atrium RA shown in Figure 1 can be used to deploy a number of the regurgitation reduction spacers and associated anchors described herein. It will also be understood that different access paths are used for repairs on the left side of the heart at the mitral valve, and that the devices disclosed herein may be used or easily adapted for use at that target annulus.

[0137] Figure 2 illustrates an array of both sub- and supra-annular anchors distributed around a regurgitation reduction spacer 30 positioned within the leaflets of a tricuspid valve and tethered to surrounding tissue using an array of both sub- and supra-annular anchors. Subannular tether / anchor pairs 32, 34 are anchored within the right ventricle RV, while supra- annular tether / anchor pairs 36, 38 anchor to the tricuspid annulus TA. Each tether 32, 26 is desirably length-adjustable, and the ability to customize the placement and length of the tether / anchor pairs greatly expands the spacer anchoring choices.

[0138] In some implementations, there are at least two of the supra-annular anchors 38 to center the spacer 30 within the tricuspid valve, however, four tethers 36 and anchors 38 are preferably. The anchors 38 can be distributed generally evenly around the tricuspid annulus. In some implementations distribution of the tethers avoids placement near to the sensitive atrioventricular node. The anchors 38 are illustrated as simple corkscrew-type anchors.

[0139] In addition to supra-annular anchors, the tethering arrangement of Figure 2 also shows a plurality of sub-annular anchors. Specifically, there are three pairs of tethers 32 and anchors 34 connected to a distal end of the spacer 30 and attached to tissue within the right ventricle. The anchors 34 are shown attached to the outer wall, adjacent the right ventricular apex RVA, and in the inner septal wall SW.

[0140] Deployment of the system shown in Figure 2 can involve first securing the subannular anchors 34 and then the supra-annular anchors 38, and extending the associated tethers 36, 32 outside of the body. The tethers 36, 32 are then connected to the spacer 30, or routed through the spacer to a control handle for length adjustment. Then, the physician advances the spacer 30 along the array of tethers 36, 32 until it is properly positioned within the valve leaflets, as may be determined under fluoroscopy. Finally, after adjusting the length or slack in thetethers to produce good regurgitation reduction, the tethers 36, 32 are locked with respect to the spacer 30.

[0141] Figures 3A and 3B are enlarged views of the right side of the heart in section illustrating a regurgitation reduction spacer 50 positioned between tricuspid valve leaflets and having supra-annular anchoring arms 52 and a malleable central mount 54. Figure 3C is an enlargement of the end of one of the supra-annular anchoring arms 52 of Figure 3A showing an anchor 56 embedded into surrounding annulus tissue. The anchor 56 is shown as a corkscrewtype, but may be any of a variety of tissue anchors as is known in the art. There are four generally evenly-distributed anchoring arms 52 that extend outward to the fibrous tissue of the tricuspid annulus. The anchors 56 may be screwed into the tissue using a separate instrument extended from outside the body that is then removable, as will be described below. Alternatively, the anchors 56 are simple barbs which are pushed directly into the tissue, or clips which self-actuate.

[0142] The spacer 50 connects to the anchoring arms 52 and is suspended within the leaflets via the central mount 54 which has one or more plastically-deformable components (e.g., a coiled neck or strut). Upon implantation, if there is initially more coaptation or contact on one side than the other, the leaflet(s) on the contacting side may apply greater lateral force to the spacer 50 compared to the leaflet(s) on the side with less coaptation. That is, the repetitive buffeting by the leaflets contacts the spacer 50 and moves it, typically towards the center of the annulus.

[0143] Figure 4A shows a proximal end of the spacer 50 with the central mount 54 straight as it is immediately post-implant. The central mount 54 plastically deforms in response to the asymmetrical forces applied to the spacer 50 by the surrounding leaflets, such that the spacer becomes suddenly or gradually “centered” (although this centering may be a center of force / coaptation rather than a geometric center - e.g., of the valve annulus). Figure 4B is the same view showing the central mount 54 having been deflected by the leaflets after a period of time in the body. The movement arrow shows the direction in which the spacer 50 moves, such that the central mount 54 now has an S-shape. This approach may also have a long-term advantage as the implant adapts to gradual changes in the valve anatomy. That is, the equilibrium position of the spacer 54 may change over time.

[0144] Figure 5A is a supra-annular view of a proximal end of an alternative spacer 60 of the present application anchored at the tricuspid annulus, and Figure 5B is a partial sectional view thereof. In this version, a disk-shaped frame 62 is secured (e.g., anchored) to the annulus by the peripheral anchors 64, and extends from these anchors across the upstream side of the valve. Again, the anchors 64 may be a corkscrew-type, as shown, or any other tissue anchors known in the art.

[0145] The frame 62 is highly permeable to blood flow, to the extent that, alone, it does not materially obstruct blood flow. However, it may advantageously obstruct a previously- flailing leaflet from flapping into the atrium. At or near the center of the frame 62 and / or the valve, the spacer 60 is shown as a cylindrical object supported or suspended between the valve leaflets. The spacer 60 may be a separate component that may be attached to the frame 62 during manufacture, or that may be attached to the frame in vivo. For some applications, the spacer may be defined, at least in part, by part of the frame 62. The frame 62 serves to hold the spacer 60 in place, but may also guide the leaflets toward better coaptation. The spacer 60 may be inflatable, such as with blood, or constructed in any manner described herein or as disclosed in prior applications.

[0146] As illustrated, the frame 62 comprises a circular outer ring 66 connected to a circular inner ring 68 via a plurality of radial struts 70. The anchors 64 pass through grommets or cleats 72 fixed to the outer ring 66. A porous mesh or net 74 extends across a portion but not all of the spaces defined between the radial struts 70. In particular, as shown, the net 74 extends between each of the radial struts near the outer periphery of the spaces adjacent the outer ring 66 in polygonal segments. The partial panel provided by the net 74 both permits adequate blood flow through the frame 62 but also treats leaflet prolapse by preventing any of the three leaflets from inverting from its normal curvature toward the ventricle into the atrium. That is, sometimes when the valve closes, fluid pressures act on the leaflets to cause them to prolapse into the atrium. The various components of the frame 62 including struts and net may be made of one or more biocompatible metals or polymers.

[0147] Figures 6A-6C are sectional views showing several steps in the deployment of supra-annular anchors 80 of another spacer 82 of the present application, and Figure 6D is a perspective view of the spacer implanted at the tricuspid annulus.

[0148] Both the anchors 80 and the spacer 82 are advanced to the target annulus by passing them through a sheath 84. A guidewire 86 may be steered through the vasculature and through the target valve annulus to guide the sheath 84 and spacer components. The anchors 80 may be advanced within or at the distal end of one or more smaller delivery tubes 88 that pass through the larger access sheath 84 and may be manipulated from a proximal end thereof, or in other words from outside the body. The delivery tubes 88 are directed to pre-determined locations around the target annulus using visualization technique such as fluoroscopy, echocardiography, ultrasound, imaging cameras, and the like. The particular anchor 80 is shown as a corkscrew-type, such that the associated delivery tube 88 may be used to rotate it into the tissue. Of course, as mentioned elsewhere, the particular type of anchor 80 may change. Each anchor 80 may have a tether 90 connected thereto which passes up through the delivery tube 88.

[0149] Figure 6B schematically shows a number of anchors 80 pre-installed around the target annulus with the tethers 90 coupled to a winding or reel mechanism 92 on the spacer 82. The spacer 82 advances through the access sheath 84 until it is positioned within the valve leaflets, as seen in Figures 6C and 6D. Again using visualization, once the spacer 82 is positioned the extent of any blood regurgitation through the valve is observed. Depending on the amount of regurgitation, the tethers 90 are retracted toward the spacer 82 using the reel mechanism 92. The reel mechanism 92 may be configured to pull all of the tethers 90 inward simultaneously, or the tethers may be separately controlled. Furthermore, the reel mechanism 92 may be remotely controlled, such as via wireless signals, or a control instrument may remain connected to the spacer 82 for such purpose (not shown).

[0150] One variation on the retractable tether configuration described above is to first embed untethered anchors 80 which have magnetic properties. After the separate anchors 80 arc deployed, the tethers 90 which extend outward from the reel mechanism 92 are then connected to the anchors 80 using a magnetic cap or disk 94. This technique may speed up the process of embedding the anchors 80 and simplify the mechanism by aggregating the tethers 90 and magnetic disks 94 with the spacer 82.

[0151] Figures 7 A and 8A are perspective and sectional views of another spacer assembly 100 with supra-annular anchors in a first step of deployment. The spacer assembly 100 comprises a spacer 102 having a tubular wall with a generally cylindrical exterior terminating in a hemisphere, and a hollow interior. A plurality of supra-annular anchoring arms 104, whose deployment is controlled by a proximal shaft 106, have outer lengths that are incorporated into or otherwise attached to the cylindrical wall of the spacer 102. The anchoring arms 104 are initially elongated into linear orientations as shown for passage through an access sheath (not shown). More particularly, the anchoring arms 104 may be formed of highly flexible bars that are initially bent into elongated J’s, with the inner end of each J inner end bent 180° and connected to a control disk 108 to which the shaft 106 is attached. The shaft 106 has a central throughbore sized to travel over a central rod 109 which extends distally into the spacer 102 interior.

[0152] Figures 7B and 8B show the spacer assembly 100 with the supra-annular anchoring arms 104 radially extended to anchor at the tricuspid annulus. More particularly, the shaft 106 and control disk 108 may be displaced downward toward and eventually into the spacer 102 interior which allows the J-shaped anchoring arms 104 to bend or flex radially outward. The anchoring arms 104 may be formed of a super-elastic material such as Nitinol that assumes an outward bend as the control disk 108 moves downward. That is, the control disk 108 initially constrains the arms 104 into the linearly elongated configurations, but when the disk moves downward it forces the arms to buckle and bend outward in a mid-section due to the outer lengths of the arms being fixed to the spacer wall.

[0153] Tissue anchors 110 shown as corkscrew -type anchors are coupled to the outer extent of the mid-section of each of the anchoring arms 104 and configured to be embedded into the annulus tissue. Although not shown, a separate control instrument such as shown above at 88 in Figure 6 A may be utilized to individually embed the anchors 110, or the driver for the anchors may be incorporated into the implant, such as shown in Figures 9-10 as described below. Alternatively, a different type of anchor 110 such as a barbed tip (or a self-deploying clip) may be utilized which is simply pierced into the annulus tissue once the anchoring arms 104 extend far enough radially outward. Those of skill in the art understand that there are various ways to anchor structure to the fibrous annulus tissue.

[0154] Figure 8B shows the control disk 108 in an intermediate position, which is approximately level with the plane of the annulus. At this stage, the flexible aims 104 have beenfully extended outward, with their inner ends remaining connected to the control disk 108. Further downward movement of the control disk 108 then pulls the inner ends of the flexible arms 104 downward within the spacer 102. This distal displacement of the shaft 106 and control disk 108 into the spacer interior causes the outer extent of the mid-section of the anchoring arms 104 to retract radially.

[0155] Figures 7C and 8C show the spacer assembly 100 after further distal displacement of the shaft 106 and control disk 108 into the spacer 102. As mentioned, the control disk 108 pulls the inner ends of the flexible arms 104 into the spacer 102, which retracts the anchored ends of the arms 104 radially inward. By virtue of the anchors 110 embedded in tissue, the arms 104 radially pull the tricuspid annulus inward towards the spacer 102. This operation may be controlled under external visualization to optimize r reduction. That is, the control shaft 106 may remain connected and manipulated from outside the body while the physician monitors regurgitation and adjusts the length of the flexible anus 104 in real-time. Once the regurgitation has been minimized, the shaft and central rod 109 are disconnected from the control disk 108 and removed from the body.

[0156] Figure 9A is a perspective of a further spacer and supra-annular anchoring assembly 120 prior to deployment, and Figures 9B and 9C are sectional views showing two steps in deployment of the spacer and anchoring assembly. The assembly 120 includes a distal spacer 122 which is shown in an expanded configuration attached at the distal end of a control shaft 124. The control shaft engages a plurality of flexible anchoring arms 126 which are shown in Figure 9 A in their linearly constricted states for delivery. An inner control tube 128 has a lower control disk 130 attached thereto. Distal ends of the flexible anchoring arms 126 connect to the control disk 130, while proximal ends thereof connect to an upper control disk 132 affixed to the control shaft 124 (see Figure 10A). The control shaft 124 and control tube 128 are aligned with a central axis of the spacer 122.

[0157] Figures 10A-10C are detailed views of the spacer and anchoring mechanism 120 of Figure 9A. The inner control tube 128 is linearly displaceable within the control shaft 124 and movement thereof determines the configuration of the anchoring arms 126, as will be shown. Initially, the control shaft 124 and upper control disk 132 are retracted proximally to cause the anchoring arms 126 to lengthen and radially constrict into the configuration of Figure 9A. Oncethe spacer 122 is positioned within the tricuspid valve leaflets, the control shaft 124 and upper control disk 132 advance distally such that the proximal ends of the anchoring amis 126 arc displaced toward the distal ends. This causes mid- sections of the flexible anchoring aims 126 to buckle and bend outward into the pyramidal configuration shown such that the mid-sections extend outward a distance sufficient to reach the target annulus. It should be mentioned that there can be four anchoring aims 126, although there may be as few as three and more than four.

[0158] Figure 9B shows the anchoring arms 126 splayed outward and a plurality of anchors 134 embedded into the annular tissue. The assembly 120 incorporates a mechanism for advancing the anchors 134 into the tissue. As shown, the anchors 134 are of the corkscrew type, and each one has a rotatable actuation rod 136 engaged therewith. The actuating rods 136 extend along and within a portion of each of the anchoring aims 126, and cooperate via elements extending through the control shaft 124 with an exterior control handle (not shown). As illustrated, each of the anchoring aims 126 has an outer bifurcated portion in the mid-section which forms an aperture 138 (see Figure 10C) through which the associated anchor 134 projects, and which enables engagement by the inner actuating rod 136. The actuating rods 136 are flexible so as to enable bending with the anchoring arms 126. After rotating and embedding the corkscrew anchors 134 into tissue, the actuating rods 136 remain within the assembly 120, though proximal actuating shafts (not shown) extending to the control handle are disengaged.

[0159] Once the assembly 120 is deployed, the spacer 122 will block the gap between the leaflets and ensure better coaptation. The anchoring arms 126 may be formed by thin bands of a super elastic material such as Nitinol, and the four anchors are helical or corkscrew-type, or other tissue anchor as is well known. Once the arms 126 are deployed to reach the annulus and the anchors 134 screwed into the tissue, the arms may be retracted to fine-tune the effectiveness of the spacer 122 in preventing or minimizing regurgitation. More particularly, by changing the distance between the lower and upper discs 130, 132, one can alter the diameter described by the anchors 134, and thus the relative distance between the spacer 122 and the surrounding annulus. This action is accomplished by proximally and distally displacing the inner control tube 128, which in turn displaces the lower disk 130 attached to the distal ends of the arms 126. Anchoring only in the annulus has advantage of reducing the risk of entanglement in the ventricular chordae.

[0160] Figure 10D is a perspective view of a single -piece element forming the thin bandlike flexible anchoring arms 136 and control discs 130, 132 for the spacer and anchoring assembly of Figure 9A. The single-piece element may be formed exclusively of a single tube of Nitinol which is laser cut to form the shapes as shown. Instead of solid discs, the control discs 130, 132 are formed from and / or can comprise tube segments which have apertures that can be engaged for axial displacement thereof.

[0161] Figures 11A and 12A are perspective and sectional views of another spacer and supra-annular anchor assembly 150 in a first step of deployment. The assembly 150 comprises a mesh-like member 152 having a fabric or bioprosthetic skirt 154 that forms the spacer. An inner control shaft 156 extends from within a delivery tube 158 and the shape of the mesh-like member 152 may be adjusted by displacing its proximal and distal ends relative to one another, as will be shown. That is, the mesh-like member 152 is formed of flexible connected filaments or struts in a generally tubular shape that radially expands when compressed and radially contracts when elongated. In the initial delivery configuration, the mesh-like member 152 is elongated and radially narrowed until it reaches a position within the tricuspid valve.

[0162] Figures 11B and 12B show the assembly 150 with the mesh-like member 152 radially extended outward to the tricuspid annulus. More particularly, the delivery tube 158 which is attached to a proximal end of the mesh-like member 152 is advanced while the control shaft 156 attached to the distal end is held stationary. This inverts the proximal end of the meshlike member 152 to the inside, which causes the intermediate struts to splay radially outward into a flange 160 having a diameter Di. Figures 1 IB and 12B also show a plurality of anchors 162 that are installed through the stmts at the outer circumference of the flange 160. The anchors 162 may be the corkscrew-type, as described herein, or another type. Separate installation of each of the anchors 162 may be accomplished using a tubular instrument 164 as shown.

[0163] Figures 11C and 12C show the assembly 150 with the flange 160 radially retracted to pull the tricuspid annulus inward towards the spacer 154. In some implementations, the spacer 154 may incorporate an inner ring 166 which, though flexible, ensures a resilient annular shape. If the distal end of the delivery tube 158 is further advanced into the ring 166, the proximal end of the mesh-like member 152 is further inverted to the inside of the structure which pulls the upper flange 160 with it. This reduces the outer diameter of the flange 160 to a smallerdiameter D2 and constricts the annulus. This operation may be conducted under visualization, as described above, to optimize the regurgitation reduction of the assembly 150. Once the appropriate amount of regurgitation reduction is observed, the relative positions of the distal and proximal ends of the mesh-like member 152 may be fixed, such as by detaching a distal tip of the delivery tube 158 which can be affixed relative to the inner control shaft 156.

[0164] Figure 13A is a perspective of a still further spacer and supra-annular anchoring assembly 180 after deployment, and Figure 13B is a sectional view thereof illustrating a range of lateral movement of the spacer. The assembly 180 comprises a spacer 182 which is supported on an axial post 184 between the valve leaflets. A plurality, e.g., four, support arms 186 extend outward at an angle from the post 184 and are secured to the annulus using anchors 188. Again, a variety of different anchors can be used.

[0165] With reference to Figure 13B, an axial fixation bolt 190 extends through the hollow post 184 and terminates in a lock nut 192. The lock nut 192 resides within a cavity formed by a generally cylindrical slider 194 which, in turn, is positioned for lateral movement within a housing 196 attached at a proximal end of the spacer 182.

[0166] Figures 14A and 14B are sectional views of the spacer and anchoring assembly 180 showing a range of motion post-implant prior to fixation of the lock nut 192. Depending on the influence of the valve leaflets, the spacer 182 and its housing 196 are urged into a particular position which represents an equilibrium within the leaflets. This position most reliably prevents regurgitation through the leaflets based on the forces from the leaflets themselves. The housing 196 defines a large throughbore 198 that accommodates relative lateral movement of the bolt 190, and an enlarged cavity 200 that accommodates relative lateral movement of the slider 194. Figure 14A shows the spacer 182 and its housing 196 buffeted to the right, so that the bolt 190 and slider 194 move to the left within their respective cavities. Conversely, Figure 14B shows the spacer 182 displaced to the left, and the bolt 190 and slider 194 moved to the right within their respective cavities. After a period of time, the physician can detect via visualization no or minimal regurgitation and a generally stationary position of the spacer 182, and lock the position thereof. This is accomplished using the bolt 190 which may have a proximal end with a faceted recess 191 (e.g., hex) for applying rotation to the bolt to tighten against the lock nut 192.

[0167] As shown in Figures 13-14, the spacer 182 will be “floating” along the anterior- posterior (A-P) and septal-lateral (S-L) axis of the annular plane. By floating, the spacer 182 allows the leaflet contact to push it, centering it to the maximal gap area - which is the optimal position for the spacer. Some current spacer fixation solutions also allow the spacer to be moved by the leaflets during systole, but during diastole the spacer is pulled back, by a resilient fixation for example, to the original orientation. There may be a few issues with these pendulum motions. By the time it takes the leaflet to move the spacer during systole, the valve closing is delayed, increasing the closing volume. When the tricuspid valve closure is delayed, the pulmonary artery (PA) opening is delayed potentially decreasing stroke volume. Leaflet abrasion sometimes occurs from the repeated motion against the spacer. Also, the leaflet force may not be enough to overcome the force from the resilient mounting placing the spacer in a suboptimal location at peak systole. The assembly 180 holding the spacer 182 prevents it from moving in the atrium-ventricular axis but allows complete freedom to move in the A-P and S-L axis, allowing the spacer to be pushed by the leaflets during systole but with no motivation to change position during diastole and by that preventing the issues described above. The spacer 182 should be of the same specific gravity as the blood so that the only forces applied are by the leaflets.

[0168] Figure 15 is a top plan view of the tricuspid annulus showing a spacer and anchoring assembly similar to the assembly 180 after fixation. As shown in this Figure, there are two different types of support arms. Rigid support arms 202 may be rotationally fixed with respect to a central post 204. Articulated support arms 206 may include locking pivots 208 along their lengths which can be used to permit additional range of movement of the spacer. Each of the pivots 208 may have a locking nut thereon for fixation once the proper spacer position is found.

[0169] Figure 16A is a perspective of a still further spacer and supra-annular anchoring assembly 220 after deployment, and Figure 16B is a sectional view thereof illustrating a range of lateral movement of the spacer. The assembly 220 again includes a regurgitation reduction spacer 222 suspended on a post 224 from a central hub 226. Support arms 228 extend outward at angles from the hub 226 to anchors 230 at the annulus, much as described above. The assembly220 operates somewhat similarly to the assembly 180 described above, in that the spacer 222 can self-position laterally between the leaflets.

[0170] Figure 16B shows the assembly 220 in section. The spacer 222 comprises an outer generally tubular wall 232 connected to the post 224 via a pair of flexible membranes 234. The membranes 234 extend across the ends of an inner cavity of the spacer 222 in order to provide sealing irrespective of the lateral position of the spacer. The membranes 234 are shown as corrugated or pleated to allow stretching / compression on one side or the other and accommodate this lateral movement. The spacer 222 may further include an outwardly-bulged portion 236 at its midplane which may be formed by an outer skin covering a compressible inner material such as foam. The outwardly-bulged portion 236 may help coapt against the leaflets and further reduce regurgitation.

[0171] Figure 17 is a sectional view of an assembly 240 having a malleable spacer 242 attached to supra-annular arms 244 via a central hub 246, the arms terminating in anchors 248 at the annulus. Figures 18A and 18B are plan views of the tricuspid annulus showing sectional views of the malleable spacer 242 before and after a shape change thereof.

[0172] In this construction, a weakly-expanding frame biases the spacer 242 to expand, filling it with blood. Because the frame is weakly-expanding, its shape is affected by the leaflets pressing against it, and therefore naturally optimizes into irregular shapes to fill the gap between the leaflets. The weakly-expanding frame is attached to (e.g., covered in or lined by) a pouch that comprises a permeable fabric that allows cells and liquid in, but does not allow clots out. Because the frame is weakly-expanding, the shape of the pouch is affected by the leaflets pressing against it, which typically forms an irregular triangle with non-linear sides. Once the blood clots and fibrosis occurs, the shape becomes chronic. This approach could be used for any type of spacer mounting - e.g., ventricular, atrial, or annular. Not all of the pouch needs to be made from the permeable fabric. It could be primarily impermeable, with a “window” of permeable fabric. Optionally, rather than a weak frame that extends over substantially all of the surface of the pouch, the frame could be a minimalistic armature that pulls the pouch open to increase its volume, but that doesn't particularly contribute to its shape.

[0173] Figure 19 is an enlarged sectional view of the right side of the heart showing one an example spacer 250 of the prior art in position for regurgitation reduction. In this configuration, the spacer 250 may be anchored on the atrial end via a shaft 252. Additionally, a distal rail 254 extends to a ventricular anchor 256, which is illustrated as positioned to the outside of the heart muscle. There are various ways to anchor a spacer in this regard, including corkscrew anchors to the inner wall of the ventricle.

[0174] Figure 20 is an enlarged sectional view of the right side of the heart showing a generally cylindrical spacer 260 of the present application with both supra- and sub-annular anchors, the spacer being sized to fit within the leaflets of the atrioventricular valve. Primarily, the spacer 260 is supported on an atrial side of the valve by a crossbeam 262, and is attached to a ventricular anchor rail 264 on the ventricular side that terminates in an anchor 266. The ventricular anchor rail 264 has a length sufficient to extend from the spacer 260 when positioned at the atrioventricular valve and terminates in a tissue anchor (not shown) for anchoring in ventricular tissue.

[0175] With reference to Figures 21A and 21B, the spacer 260 has a dynamic sail or skirt 270 capable of expanding and contracting with an open distal end and a closed proximal end. The dynamic skirt 270 is mounted on and surrounds a hollow bushing 272 which slides along the ventricular anchoring rail 264. The bushing 272 is secured to a hub 276 forming a part of the crossbeam 262. Terminal ends of the crossbeam 262 fix via pivots 278 to flexible lateral beams 280 secured on each end to the annulus by anchors 282. In these images, the valve is open during the diastolic or filling phase such that blood flow arrows are shown passing downward, which tends to minimize the size of the dynamic skirt 270 because it is open on its ventricular side.

[0176] Figures 22A and 22B are schematic perspective views of the spacer 260 during a systolic phase of the cardiac cycle. The valve leaflets close against the spacer 260 which has now expanded because of the blood flow direction towards the atrium. Moreover, forces from the filling dynamic sail or skirt 270 tend to push the crossbeam 262 along the ventricular anchoring rail 264 towards the atrium which, in turn, pulls on both of the lateral beams 280. Because the ends of the lateral beams 280 are anchored at spaced apart locations, such as on both sides of the valve commissures, this tends to cinch the annulus in between which further helpsprevent regurgitation by pulling the outer ends of the leaflets together. In other words, the structure of the dynamic skirt 270 augments the coaptation of the leaflets during systole.

[0177] The skirt 270 acts as a gap filler between the leaflets and also as an actuator for the annular cinching mechanism. The skirt 270 deflates during diastole to decrease atrial / ventricular pressure gradient and is fixated around the bushing 272 which slides along the anchoring rail 264. During systole, the skirt 270 pushes the assembly toward the atrium which causes the stiff crossbeam 262 to pull on the flexible lateral beams 280. These flexible beams 280 pull inward during systole which causes the cinching effect as they pull the annular anchors closer to each other. The beams 280 may be made of a flexible polymer or even a fabric or tether-like structure. During diastole, the rod returns to its original position (at the annular plane) because the skirt 270 is deflated.

[0178] The coaptation-augmenting structure of the spacer 260 may also be anchored to the annulus via connectors or tethers arranged in a manner such that when pressure during ventricular systole forces the coaptation-augmenting structure atrially, the sites at which the connectors are anchored are pulled together. These sites may be on either side of commissures, thereby drawing opposing leaflets toward each other and improving coaptation precisely at the time that it is needed. Thus, the coaptation-augmenting structure and the dynamic contraction mutually augment each other. Note that, due to the dynamic nature of the contraction, the valve orifice is able to fully open during diastole, for ventricular filling.

[0179] Figures 23A and 23B are schematic perspective views of an alternative spacer assembly similar to that in Figure 20 in both diastolic and systolic phases, respectively. The assembly includes an inflatable spacer 300 suspended on a rigid linkage member 302 that pivots on a rigid crossbeam 304. The linkage member 302 pivotally attaches to a proximal end of the spacer 300 which has an opening (not shown) to permit inflation with blood. Once again, the crossbeam 304 connects at either end to flexible lateral beams 306 secured at spaced apart locations by tissue anchors 308. Figure 23A shows the diastolic phase in which the spacer 300 is deflated and moved aside by virtue of the linkage member 302 to allow blood flow into the ventricle. Figure 23B shows the spacer 300 inflated with pressured blood and centered by the closing leaflets. Once again, the closing fluid forces pushes the leaflets and the spacer 300 towards the atrium which, in turn, pushes the crossbeam 304 and lateral beams 306 in the samedirection. The lateral beams 306 are flexible and tend to cinch the annulus which augments the leaflet coaptation of the spacer 300 by shrinking the annulus circumference.

[0180] Figures 24A and 24B are sectional views through an atrioventricular annulus illustrating how sub-annular anchors of a regurgitation reduction spacer 320 are deployed using techniques of the prior art, and Figure 25 is a perspective view of the spacer and sub-annular anchors after implant. The spacer 320 is shown being delivered through an access sheath 322. At the distal end of the spacer, a plurality of flexible sub-annular anchors 324 extend axially in a constricted configuration for delivery. Figure 24B illustrates the spacer 320 having been advanced or the sheath 322 retracted such that the flexible anchors 324 are expelled below the atrioventricular annulus. The anchors 324 are biased to curl in a proximal direction underneath the leaflets of the valve.

[0181] Figure 25 shows the desired result. However, this process of expelling the anchors 324 and allowing them to curl backward upon themselves under the leaflets runs into problems. For example, one or more anchors 324 may become tangled in the chordae and not fully deploy. In such cases, the entire assembly may need to be retracted back into the sheath 322 and a second attempt at deployment made, or in the worst case the entire spacer assembly must be removed and replaced.

[0182] Figures 26A and 26B are sectional views through a tricuspid annulus schematically illustrating deployment of sub-annular anchors from a spacer 330 of the present application. The spacer 330 is once again delivered through an access sheath 332 and has a plurality of flexible ventricular anchor legs 334 configured to be delivered through a number of dogleg guides 336 fixed to a distal end of the spacer. The flexible anchor legs 334 collectively attach to a plunger 338 arranged to move axially in a throughbore of the spacer 330 when pushed by a control rod 340. Figure 26B shows the control rod 340 pushed downward to push the plunger 338 and flexible anchor legs 334 out of the dogleg guides 336. The guides 336 are each shaped so as to redirect the flexible legs 334 from a distal to a proximal direction. In some implementations, the guides can redirect flexible legs 334 with some outward lateral displacement away from the spacer 330. For example, the guides 336 may each extend along an arc of approximately 150- 180°. This enables the user to place the anchoring legs 334 at theunderside of the leaflets in the subannular groove without risk of tangling with the chordae. That is, the legs 334 pass linearly between the chordae.

[0183] Figures 27A-27C are perspective views of three alternative anchor guides that may be used in the spacer system shown in Figures 26A and 26B. Figure 27A shows a flexible anchor leg 342 passing along a first guide 344 featuring two pairs of side flanges 346. One pair of flanges 346 is positioned on a first segment of the guide 344 before the distal dogleg, and a second pair of flanges is positioned toward the terminal end of the guide. In this way, the anchor leg 342 may be constrained laterally to follow the guide 344. The anchor leg 342 may terminate in a rounded or bulbous end 348 to minimize tissue damage when positioning in the subannular groove, and may also be fabric covered. Figure 27B shows the same anchor leg 342 passing along a second dogleg guide 350. In this version, a pair of rings or eyelets 352 are provided on both segments of the guide 350 for greater security that the anchor leg will remain aligned. Finally, Figure 27C shows a wire-like anchor leg 354 passing along a dogleg guide 356. The guide 356 commences with a curled tubular segment that terminates at an outlet 358 pointed in a proximal direction. The wire-like leg 354 continues around in a loop and returns to be secured within a grommet or crimp 360. Distal displacement of the leg 354 indicated by the arrows increases the size of the loop between the outlet 358 and the crimp 360; the loop forming an atraumatic anchor that seats in the subannular groove.

[0184] Figures 28A-28C are sectional views through the tricuspid annulus schematically illustrating deployment of a further sub-annular anchoring system of the present application. As mentioned above, deploying ventricular anchors that curl backwards upon themselves is problematic in that they can become tangled in the chordae. The idea is to avoid requiring ventricular legs to deflect or “swing” laterally because this increases their chance of undesirably engaging chordae.

[0185] A spacer 380 is shown being delivered by an access sheath 382. The ventricular anchor legs 382 are movable axially from within the spacer 380 to a position extending out of a distal end thereof, as seen. Once expelled from the distal end of the spacer 380, ventricular anchor legs 384 are part of a mechanical linkage whereby connectors deflect laterally but movement of the actual legs is primarily translation. More particularly, each of the legs 384 is flexible and is constrained in a narrow delivery configuration. The legs 384 arc first pushedaxially out from within the spacer 380 below the valve annulus and chordae. A first constraint 386, such as a suture or other such primary cinch, constrains all of the anchor legs 384. Figure 28B shows the anchor legs 384 having splayed outward from each other after release of the first constraint 386. Each ventricular anchor leg extends distally in a first section and has a terminal end bent in a proximal direction and held inward aligned with the first section by secondary constraints 388. The terminal ends of each of the anchor legs 384 remain held inward by secondary constraints or cinches 388 which are individual to each leg. Figure 28C shows release of the terminal ends of the anchor legs 384 by removing the secondary constraints 388. This causes the anchor legs 384 to spring outward. At this stage, either the anchor legs 384 or the entire spacer 380 may be axially retracted to pull the terminal ends of the anchor legs into the subannular groove. The primary and secondary constraints or cinches may be wires encircling the respective legs or groups of legs that are remotely releasable from outside the body.

[0186] Figures 29A-29C are sectional views through an atrioventricular annulus schematically illustrating deployment of a still further sub-annular anchoring system of the present application. Again, a spacer 400 is shown after having been positioned within the leaflets. A plurality of flexible ventricular anchor legs 402 are shown constrained within an inner throughbore 404 of the spacer. Each ventricular anchor leg 402 extends distally in a first section and has a terminal end bent in a proximal direction and held inward when in the throughbore. Figure 29B shows distal displacement of a pusher 406 acting on a plunger 408 which displaces all of the anchor legs 402 in a distal direction. The pusher 406 extending proximally through an access sheath (not shown) and attached to displace the plunger 408. The legs 402 remain constrained until their terminal ends are expelled from the end of the throughbore 404. Figure 29C shows in dashed line expansion of the anchor legs 402 once they are expelled from beyond the distal end of the spacer throughbore such that the terminal ends open up to expand radially away from the first sections. At this stage, the plunger 408 is retracted to pull the terminal ends of the legs 402 up into the annular groove; again, reducing the chance of entanglement with the chordae.

[0187] Figures 30A and 30B are perspective views of an atrioventricular annulus illustrating two steps in deployment of a sub-annular anchoring system for a spacer of the present application, Figures 31A and 3 IB are sectional views thereof, and Figures 32A and 32B areschematic plan views thereof. The system includes a spacer 420 at the distal end of a control shaft 422. A plurality of arcuate ventricular grasping legs 424 projects outward from the spacer 420 usable and / or for use in gathering chordae 426. Initially, the spacer 420 is delivered so that the grasping legs 424 are in a sub-annular position within the chordae 426. Figures 30B, 3 IB and 32B illustrate deployment of the grasping legs 424 to capture the chordae 426. This deployment comprises either rotation or extension of the arcuate grasping legs 424. Figure 32B best shows the end result where pairs of grasping legs 424 combined to capture a number of chordae 426. At the same time, the spacer 420 converts from a generally circular cross-section to an elongated or more elliptical cross- section, which can be done via an internal mechanism in conjunction with movement of the grasping legs 424.

[0188] Figures 33A and 33B are schematic plan views of an alternative sub-annular anchoring system utilizing chordae capturing legs in two stages. As shown, the spacer 440 also has a number of arcuate grasping legs 442 extending outward therefrom. Each of the grasping legs 442 rotate with a pinion gear 444 acted on by a rack 446 within the spacer 440. As shown, there are two racks 446 that move away from one another and act on two of the pinion gears 444. Although not shown in Figure 33B, outward movement of the racks 446 brings two pairs of grasping legs 442 together, thus capturing chordae 448.

[0189] One sequence of deploying the systems of Figures 30-32 or Figure 33A is to first advance a delivery sheath into the left atrium through I VC or the right atrium via a transeptal procedure. The spacer is then expelled from the delivery sheath inside the atrium which opens the ventricular grasping legs from each side of the device. The spacer is positioned at the appropriate coaptation line within the leaflets, and then lowered beneath the leaflet / coaptation plane. The grasping legs are thus positioned in between and over the chordae. The spacer is then deployed in way that it changes from a circular to an elliptical geometry, while at the same time the grasping mechanism is activated by rotating or extending the arcuate grasping legs. The mechanism could be a rack and pinion configuration as seen in Figure 33A, wherein the rack is connected to the outer geometry of the spacer to change it from a circular to an elliptical shape. Further, as the racks move away from the center of the circular structure, they activate the pinion gear's which rotate the grasping elements. The grasping elements pull the chordae together towards the center of the implant (from each side). The locking element acts as gap filler inorder to eliminate residual regurgitant flow, and the leaflet movement facilitates an annulus reduction effect.

[0190] Figures 34A and 34B are sectional views through an atrioventricular annulus illustrating two stages in deployment of a spacer 460 having ventricular legs 462 for capturing chordae 464. A delivery sheath 466 is shown emerging from the IVC. Figures 35A and 35B are schematic plan views of the spacer 460 before and after capturing chordae, and Figures 36A and 36B are schematic sectional views thereof. In this case, the ventricular legs 462 are arranged in a spiral configuration relative to one another such that rotation of the spacer 460 causes each leg to grasp a number of chordae. At the same time, the spacer 460 once again converts from a generally rounded or circular configuration to a more oval lengthened shape.

[0191] Figure 37 is an enlarged sectional view of the right side of the heart showing an example spherical spacer 480 having supra-annular anchoring arms 482. The arms 482 may be configured much like any of the other supra-annular anchors described herein.

[0192] Figure 38 is a partially cutaway view of the spherical spacer 480 in an expanded configuration. The spacer 480 includes a plurality of inner connected walls 484 which may be expanded into a honeycomb structure to define a plurality of open cells 486. A fabric or other biocompatible cover 488 surrounds the inner collapsible / expandable structure. The cover 488 is desirably a thin fabric which allows blood to pass through and enter the cells 46 and solidify.

[0193] Figures 39A-39C schematically illustrates three steps in expansion or deployment of the spherical spacer 480. First of all, the inner connected walls 484 are collapsed flat and the entire structure rolled into a spiral as shown. This can be delivered through a relatively small access sheath to the target annulus. Figure 39B shows the structure after having been unrolled into a semi-circular Hat object. The leaves of the connected walls 44 can then be opened up as shown, sweeping one end-layer around an axis of rotation to meet the other end-layer - the honeycomb structure shown in Figure 39C becoming apparent during this process. These operations can be accomplished using various constraints and tethers such as sutures to pull the structure into its three-dimensional shape.

[0194] In its implanted state, the spacer 480 appears similar to a honeycomb-like paper decoration, but rather than having openings at its surface (the openings being of cavities that taper inward to the center of the object), the surface is covered with the thin fabric 488. Theentire structure may be made from fabric - although the inner parts may be a different fabric than the cover 488.

[0195] Figure 40 is an enlarged sectional view of the right side of the heart showing deployment of an inflatable spherical spacer 500 having supra-annular anchoring aims 502, and Figures 41A and 41B are sectional views through the spacer showing an internal blood pump system for inflating the spacer. A delivery sheath 504 is shown extending from the IVC in contact with the spacer 500. Various deployment tools may be passed through the sheath 504, as is well known.

[0196] With reference to Figure 41A, the spacer 500 includes a rigid inner tube 506 surrounded by an outer inflatable skin 504 connected thereto. The inner tube 506 defines an inner chamber 510 that is acted on by a plunger 512 which forms a part of a reciprocating pump. The plunger 512 may be displaced axially using a number of means, including a schematically shown threaded actuator 514. The inner tube 506 also features a pair of valves 516, 518.

[0197] Figure 41A shows a first step in inflating the spacer 500 by retracting the plunger 512. This creates a negative pressure within the chamber 510 which opens an inlet check-valve 516 at the lower end of the tube 506. Blood flows into the chamber 510 because the lower end of the tube 506 is open to the ventricle. Figure 4 IB shows a reverse displacement of the plunger 512 which closes the inlet check-valve 516 and opens an outlet check-valve 518. The outlet check-valve 518 opens into the space between the tube 506 and the outer skin 508 such that blood flows into the space and inflates the spacer 500. Because the volume of the chamber 510 is typically smaller than the volume of the space within the skin 508, a number of reciprocating movements of the piston 512 may be required to inflate the spacer 500.

[0198] The piston 512 (and shaft) as shown may remain part of the implant, and the threading 514 at the top may represent a reversible coupling to the delivery tool. Some expandable heart valve spacers (gap-fillers) of the prior art may be expanded by a sheet-covered self-expanding frame, but the result is often not a smooth surface (e.g., inner frame shape is apparent from outside). Others arc inflated with saline, but this can leak over time, reducing the size of the spacer. Blood is less likely to leak than saline - especially once it solidifies within the spacer.

[0199] Figure 42 is an enlarged sectional view of the right side of the heart showing deployment of another inflatable spacer 520 having supra- annular anchoring arms 522 being delivered by a sheath 524. Figures 43A and 43B are sectional views through the spacer 520 showing an internal blood pump system for inflating the spacer as well as a supplemental inflation lumen.

[0200] The spacer 500 of Figures 40-41 may be actively inflated with the subject’s own blood as described above. However, it may be advisable to add a pretest function by which the spacer is first reversibly inflated with saline in order to determine / optimize efficacy - e.g., the amount of inflation required, and will the inflated implant be effective for the subject. The idea is to initially use a different mechanism (e.g., an extracorporeal pump or syringe) to reversibly inflate the spacer with saline to determine / optimize efficacy prior to filling with blood (which is chronic, e.g., due to clotting). During the pretesting stage, the blood pump could be in a locked state, or simply not be operated until desired.

[0201] In some implementations, the inner structure of the spacer 520 is generally similar to that described above, with a rigid tube 526 surrounded by a flexible skin 528. An inner chamber 530 may be filled and emptied using check-valves 534, 536 and a piston 537, as described above. In addition, a fluid conduit 538 may be extended from the delivery sheath 524 to the interior of the skin 528. Figure 43A shows an input of saline through the fluid conduit 538 to inflate the spacer 520 to the shape in Figure 43B. At this stage, more saline can be injected or removed to test the efficacy of the spacer in reducing regurgitation, such as under visualization. Ultimately, the saline is removed through the conduit 538, and the pump mechanism activated to fill the spacer with blood, as described above.

[0202] An example sequence of use of the device of Figures 42-43 is shown below:

[0203] 1. Anchoring I positioning the device in place

[0204] 2. Pushing saline to inflate balloon with saline only - efficacy evaluation

[0205] 3. Optionally reposition I re-inflate I change volume - decide

[0206] 4. Pull saline to deflate balloon

[0207] 5. Activate blood valve - e.g., pulling a wire, unscrewing a shaft

[0208] 6. Pull syringe - blood coming into the device shaft

[0209] 7. Push syringe - blood inflating the balloon

[0210] 8. Repeat these steps to inflate more

[0211] 9. Release

[0212] While the foregoing is a complete description of the preferred implementations of the invention, various alternatives, modifications, and equivalents may be used. Moreover, it will be obvious that certain other modifications may be practiced within the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween; and supra-annular anchoring arms connected to the proximal end of the spacer by a malleable central mount extending axially from the spacer, the anchoring arms being generally evenly distributed around and extending outward from a proximal end of the central mount sufficiently far to reach the atrioventricular annulus, each anchoring arm terminating in a tissue anchor, wherein the central mount has one or more plastically- deformable components such that a position of the spacer relative to the atrioventricular annulus may be adjusted from leaflet contact therewith.

2. The device of claim 1, wherein each tissue anchor is selected from a group consisting of corkscrew-type anchors, barbs and clips.

3. The device of claim 1, wherein there are four generally evenly distributed anchoring arms.

4. The device of claim 1, wherein the plastically-deformable components of the central mount comprises a coiled neck.

5. A device adapted to be positioned within a valve, the valve having an annulus and leaflets extending inward therefrom, the device comprising: an adjustable spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having a compressed delivery configuration and a radially expanded implant configuration;a malleable central mount extending axially from the spacer; and supra-annular anchoring arms coupled to the malleable central mount, each supraannular anchoring arm comprising a tissue anchor, wherein the central mount comprises one or more plastically-deformable components such that a position of the spacer relative to the atrioventricular annulus may be adjusted from leaflet contact therewith.

6. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween,; and a supra-annular anchoring frame having an inner ring attached to a proximal end of the spacer and an outer ring connected to the inner ring via a plurality of radial struts having spaces defined therebetween, the outer ring being sized to be in contact with the atrioventricular annulus and having a plurality of tissue anchors, the frame further having a porous mesh or net that extends across a portion but not all of the spaces between the radial struts.

7. The device of claim 6, wherein each tissue anchor is selected from a group consisting of corkscrew-type anchors, barbs and clips.

8. The device of claim 6, wherein each tissue anchor passes through a grommet or cleat fixed to the outer ring.

9. The device of claim 6, wherein the inner ring and outer ring are circular.

10. The device of claim 6, wherein the inner ring is a separate component from the spacer and attached to the spacer in vivo.11 . The device of claim 6, wherein the porous mesh or net extends between each of the radial struts near an outer periphery of the spaces adjacent the outer ring in polygonal segments.

12. A device adapted to be positioned within a valve, the valve having an annulus and leaflets extending inward therefrom, the device comprising: an adjustable spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having a compressed delivery configuration and a radially expanded implant configuration; and a supra-annular anchoring frame, the frame comprising: an inner ring attached to a proximal end of the spacer; an outer ring sized to be in contact with the atrioventricular annulus; and a plurality of radial stmts connecting the inner ring and the outer ring, the plurality of radial struts having spaces defined therebetween; a plurality of tissue anchors coupled to the outer ring; and a porous mesh or net that extends across a portion but not all of the spaces between the radial stmts.

13. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween; a supra-annular winding or reel mechanism on the spacer to which a plurality of tethers are adjustably coupled; and a plurality of tissue anchors each of which is connected to an outer end of one of the tethers.

14. The device of claim 13, wherein each tissue anchor is selected from a group consisting of corkscrew-type anchors, barbs and clips.

15. The device of claim 13, wherein the winding or reel mechanism is remotely controlled.

16. The device of claim 13, wherein each tissue anchor has magnetic properties and the tethers each connect to the tissue anchors using a magnetic cap on the end of each tether.

17. The device of claim 13, wherein a length of each tether is separately controlled with the winding or reel mechanism.

18. A method of deploying the device of claim 13, including first steering a guidewire through vasculature and through the target annulus, and advancing a delivery sheath to a location in the atrium adjacent the target annulus, pre-installing the tissue anchors around the target annulus, advancing the spacer into position within the valve leaflets, and attaching the tethers to the tissue anchors.

19. The method of claim 18, further including using fluoroscopy, echocardiography, ultrasound, or an imaging camera to observe an amount of regurgitation through the target annulus, and adjusting the tethers until a desired reduction in regurgitation is observed.

20. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular' valve having an annulus and leaflets extending inward therefrom, the device comprising: a spacer defined by a generally tubular' wall having a hollow interior and a generally cylindrical exterior sized to fit within the leaflets of the atrioventricular' valve and configured to coapt against the leaflets to reduce regurgitation therebetween; supra-annular anchoring arms formed of flexible bars each arm having an outer length connected to the proximal end of the spacer wall and an inner end bent 180° and attached to a control disk to which a movable shaft is attached, the shaft having a centralthroughbore sized to travel over a central rod which extends distally into the spacer interior such that the shaft and control disk may be displaced into the spacer interior, wherein distal displacement of the shaft and control disk causes each anchoring arm to buckle and bend outward in a mid-section and extend outward a distance sufficient to reach the target annulus; and a plurality of tissue anchors each of which is connected to an outer extent of the mid- section of one of the anchoring arms, wherein further distal displacement of the shaft and control disk into the spacer interior causes the outer extent of the mid-section of the anchoring arms to retract radially.

21. The device of claim 20, wherein each tissue anchor is selected from a group consisting of corkscrew-type anchors, barbs and clips.

22. The device of claim 20, wherein the anchoring arms are formed of Nitinol.

23. An implantable device comprising: a spacer comprising a cylindrical housing surrounding a hollow interior, the spacer sized to fit within the leaflets of an atrioventricular valve and configured to coapt against leaflets of the valve to reduce regurgitation therebetween; anchoring arms, the anchoring arms comprising: a first portion connected to a proximal end of the spacer; and a second portion comprising a 180° bend; an anchoring actuation assembly comprising: a control disk coupled to the second portion of the anchoring arms; and a movable shaft, the shaft having a central throughbore; a central rod extending distally into the hollow interior such that the shaft and control disk are displaced into the hollow interior and the movable shaft travels over the central rod, wherein distal displacement of the shaft and control disk causes each anchoring arm to buckle and bend outward in a mid-section and extend outward a distance sufficient to reach an annulus of the atrioventricular valve; anda plurality of tissue anchors each of which is connected to an outer extent of the mid-section of one of the anchoring arms, wherein further distal displacement of the shaft and control disk into the spacer interior causes the outer extent of the mid-section of the anchoring arms to retract radially.

24. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular' valve having an annulus and leaflets extending inward therefrom, the device comprising: a spacer having a proximal end and a distal end and being sized to fit within the leaflets of the atrioventricular' valve and configured to coapt against the leaflets to reduce regurgitation therebetween; a control shaft comprising an upper control disk affixed thereto and a lumen sized to travel over a concentric inner control tube that terminates in a lower control disk, the control shaft and inner control tube being aligned with a central axis of the spacer; a plurality of supra-annular flexible anchoring arms distributed around the proximal end of the spacer, a first portion of the anchoring arms coupled to the lower control disk while a second portion of the anchoring arms are coupled to the upper control disk, wherein proximal displacement of the control shaft and upper control disk relative to the lower control disk lengthens and radially constricts the anchoring arms into a delivery configuration, and distal displacement of the control shaft and upper control disk relative to the lower control disk causes mid-sections of the anchoring arms to buckle and bend outward into a pyramidal configuration such that the mid- sections extend outward a distance sufficient to reach the target annulus; and a plurality of tissue anchors each of which is connected to the mid-section of one of the anchoring arms, wherein further distal displacement of the control shaft and upper control disk relative to the lower control disk causes the outer extent of the mid-section of the anchoring arms to retract radially.

25. The device of claim 24, wherein the upper control disk, anchoring arms and lower control disk arc formed of a single-piece clement.

26. The device of claim 25, wherein the single-piece element is formed by a single tube of Nitinol which is laser cut to form the upper control disk, anchoring arms and lower control disk.

27. The device of claim 24, wherein there are exactly four anchoring arms.

28. The device of claim 24, further including a mechanism for advancing the tissue anchors into the tissue including actuating rods extending along each of the anchoring arms that cooperate via elements extending through the control shaft with an exterior control handle, wherein each of the anchoring arms has an outer bifurcated portion in the mid-section which forms an aperture through which an associated tissue anchor projects, and an outer end of an actuating rod engages each tissue anchor.

29. The device of claim 28, wherein each tissue anchor is a corkscrew-type anchor, and the actuating rods are configured to rotate about their own axes to deploy the tissue anchors.

30. A device adapted to be positioned within a valve, the valve having an annulus and leaflets extending inward therefrom, the device comprising: a mesh-like member formed of flexible connected filaments or struts in a generally tubular- shape, the mesh-like member configured to radially expand when compressed and radially contract when elongated, the mesh-like member a proximal end portion opposite a distal end portion; a spacer comprising a flexible fabric or bioprosthetic skirt attached to the meshlike member and forming a generally tubular- wall having a hollow interior and a generally cylindrical exterior sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having a resilient inner ring at a proximal end thereof;a delivery tube having a lumen within which the radially contracted mesh-like member and spacer can be received when the proximal end portion and the distal end portion of the mesh-like member are displaced apart, wherein the delivery tube is attached to the proximal end portion of the mesh-like member; an inner control shaft extending through the delivery tube and through the lumen, the inner control shaft attached to the distal end portion of the mesh-like member, the inner control shaft movable relative to the delivery tube such that a distance between the proximal end portion and the distal end portion of the mesh-like member is adjustable, wherein distal displacement of the delivery tube relative to the inner control shaft causes the proximal end portion of the mesh-like member to advance toward the distal end portion of the mesh-like member such that a proximal portion of the mesh-like member expands radially outward to form a supra-annular flange having a diameter sufficient to reach the target annulus; and a plurality of tissue anchors each of which engages the supra-annular flange and embeds in annulus tissue to anchor the supra-annular flange thereto, wherein further distal movement of the delivery tube relative to the inner control shaft causes an outer periphery of the supra-annular flange to retract radially.

31. The device of claim 30, wherein each tissue anchor is selected from a group consisting of corkscrew-type anchors, barbs and clips.

32. The device of claim 30, wherein the relative positions of the distal and proximal ends of the mesh-like member are fixed by detaching a distal tip of the delivery tube and affixing the distal tip relative to the inner control shaft.

33. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a spacer having a proximal end portion and a distal end portion and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween;an axial post through which passes a fixation bolt having a cylindrical slider affixed to a distal end thereof; a housing connected to the proximal end portion of the spacer, the housing having an inner cavity and a proximal throughbore through which the fixation bolt passes that accommodates relative lateral movement of the bolt, the cylindrical slider being held within the inner cavity and also having room for relative lateral movement therein; and a plurality of support arms connected to and extending outward from the post and terminating in tissue anchors for securing to the annulus, such that the device may be anchored to the annulus using the tissue anchors with the spacer suspended between the leaflets and being laterally movable by forces exerted by the leaflets.

34. The device of claim 33, further including a lock nut at the distal end of the fixation bolt, wherein tightening the lock nut fixes the lateral position of the slider within the cavity of the housing.

35. The device of claim 34, wherein the fixation bolt has a faceted proximal end exposed on the proximal end of the axial post for tightening the lock nut.

36. The device of claim 33, wherein the device prevents the spacer from moving in the atrium-ventricular axis but allows complete freedom to move along lateral axes.

37. The device of claim 33, wherein at least some of the support arms are articulated with locking pivots along their lengths that permit additional range of movement of the spacer.

38. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: an axial post having a proximal hub; a spacer having a proximal end portion and a distal end portion and being sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having an outer generally tubular wall connected to the post via a pair of flexible membranes that extend across proximaland distal ends of an inner cavity of the spacer in order to provide a seal across the ends irrespective of the relative lateral positions of the spacer and post; a plurality of support arms connected to and extending outward at an angle from the hub and terminating in tissue anchors for securing to the annulus, such that the device may be anchored to the annulus using the tissue anchors with the spacer suspended between the leaflets and being laterally movable by forces exerted by the leaflets.

39. The device of claim 38, wherein the membranes are corrugated or pleated to allow stretching on one side and compression on another side of the post.

40. The device of claim 38, wherein the tubular wall has an outwardly-bulged portion at its midplane formed by an outer skin covering a compressible inner material.41 . The device of claim 40, wherein the inner material is foam.

42. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a hub; a spacer connected to the hub, the spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer comprising an expanding frame and a pouch, the expanding frame providing inner support to the pouch, wherein the expanding frame biases the spacer to expand, filling it with blood through permeable fabric of the pouch, the permeable fabric configured to prevent passage of clots; and a plurality of support arms connected to and extending outward at an angle from the hub and terminating in tissue anchors for securing to the annulus, such that the device may be anchored to the annulus using the tissue anchors with the spacer suspended between the leaflets and being laterally movable by forces exerted by the leaflets.

43. The device of claim 42, wherein the pouch is primarily impermeable, with a window of permeable fabric.

44. A device adapted to be positioned within a target atrioventricular valve, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a generally cylindrical spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having a hollow bushing and a dynamic skirt surrounding the bushing, the dynamic skirt having an open distal end and a closed proximal end; an anchoring rail slidingly received within the bushing, anchoring rail having a length sufficient to extend from the spacer when positioned at the atrioventricular valve and terminating in a tissue anchor for anchoring in ventricular tissue; and an atrial anchoring assembly including a hub attached to the bushing, a rigid crossbeam attached to and extending radially outward in opposite directions from the hub and connected at each opposite end to a mid-portion of a flexible lateral beam, and atrial tissue anchors at the terminal ends of each lateral beam for anchoring into tissue at the annulus, wherein the device may be anchored at the annulus using the atrial tissue anchors with the spacer suspended between the leaflets and being axially movable by blood flowing in and out to alternately inflate and deflate the dynamic skirt.

45. The device of claim 44, wherein the lateral beams are pivotally connected to the opposite ends of the crossbeam.

46. The device of claim 44, wherein the lateral beams have lengths sufficient to anchor on opposite sides of commissures of the atrioventricular valve.

47. The device of claim 44, wherein the lateral beams are made of a flexible polymer or a fabric.

48. A device adapted to be positioned within a target atrioventricular valve, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising:a generally cylindrical spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having a hollow interior having an opening to permit inflation with blood; an atrial anchoring assembly including a rigid linkage member pivotally attached to a proximal end of the spacer, a rigid crossbeam pivotally attached at a mid-portion of the linkage member, a pair of flexible lateral beams connected to opposite ends of the crossbeam, and atrial tissue anchors at the terminal ends of each lateral beam for anchoring into tissue at the annulus, wherein the device may be anchored at the annulus using the atrial tissue anchors with the spacer suspended between the leaflets and being alternately inflated and deflated by blood flowing in and out of the spacer and movable within the annulus due to the pivoting connections.

49. A system for delivering a device to within a target atrioventricular valve, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the system comprising: a hollow access sheath having a length sufficient to extend from outside a body to the atrioventricular valve; a generally cylindrical spacer configured to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween, the spacer having a central throughbore and a plurality of dogleg guides fixed to a distal end thereof and extending radially outward; a plurality of flexible anchor legs collectively attached to a plunger arranged to move axially in the throughbore of the spacer, each anchor leg constrained to pass through one of the dogleg guides; and a control rod extending proximally through the access sheath and attached to displace the plunger, wherein the anchor legs may be deployed to the underside of the leaflets in a subannular groove by advancing the control rod once the spacer is positioned by the access sheath at the annulus.

50. The system of claim 49, wherein each dogleg guide defines an arc of approximately 150-180°.

51. The system of claim 49, wherein each anchor leg terminates in a rounded or bulbous end.

52. The system of claim 51, wherein each rounded or bulbous end is covered in fabric.

53. The system of claim 49, wherein each dogleg guide commences with a curled tubular segment that terminates at an outlet pointed in a proximal direction, and each anchor leg is a wire that passes through the curled tubular segment and continues in a loop and returns to be secured within a grommet or crimp at a distal end of the curled tubular segment, wherein displacement of the anchor leg changes the size of the loop.

54. A system for delivering a device to a target atrioventricular valve, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the system comprising: a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular valve; a generally cylindrical spacer configured to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween; and a plurality of flexible anchor legs movable axially from within a throughbore in the spacer to a position extending out of a distal end thereof, the plurality of anchor legs being constrained together in a narrow delivery configuration by a primary cinch, and each anchor leg extending distally in a first section and having a terminal end bent in a proximal direction and held inward aligned with the first section by secondary cinches, wherein removal of the primary cinch permits the plurality of anchor legs to radially separate and removal of the secondary cinches permits the terminal ends to separate from the first sections.

55. A system for delivering a device to within a target atrioventricular valve, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the system comprising: a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular valve; a generally cylindrical spacer configured to coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween; a plurality of flexible anchor legs collectively attach to a plunger arranged to move axially in the throughbore of the spacer to a position extending out of a distal end thereof, each anchor leg extending distally in a first section and having a terminal end bent in a proximal direction and being constrained when in the throughbore; and a pusher extending proximally through the access sheath and attached to displace the plunger, wherein the anchor legs may be expelled from the throughbore by advancing the pusher and plunger once the spacer is positioned by the access sheath at the annulus to permit the terminal ends to expand radially away from the first sections.

56. A system for delivering a device to a target atrioventricular valve, the system comprising: a control shaft having a length sufficient to extend from outside the body to the atrioventricular valve; and a generally cylindrical spacer attached at a distal end of the control shaft and sized to coapt against leaflets of the atrioventricular valve to reduce regurgitation therebetween, the spacer having a plurality of arcuate ventricular grasping legs projecting outward therefrom, wherein the grasping legs are convertible between a delivery position and a deployed position where pairs of grasping legs combined to capture one or more ventricular chordae.

57. The system of claim 56, wherein the grasping legs convert between the delivery position and the deployed position by rotation or extension and actuated by the control shaft.

58. The system of claim 57, wherein the grasping legs convert between the delivery position and the deployed position in conjunction with the spacer changing shape from a generally circular cross-section to an elongated or more elliptical cross-section.

59. The system of claim 56, further including a mechanism within the spacer including two racks arranged to move away from one another when actuated by the control shaft, the racks each engaging pinion gears connected to the grasping legs to rotate the grasping legs when the racks move away from one another.

60. A device adapted to be positioned within a target atrioventricular valve between an atrium and a ventricle and reduce regurgitation therebetween, the atrioventricular valve having an annulus and leaflets extending inward therefrom, the device comprising: a generally spherical spacer sized to fit within the leaflets of the atrioventricular valve and configured to coapt against the leaflets to reduce regurgitation therebetween, the spacer having an inner collapsible and expandable structure including a plurality of connected walls defining a plurality of open cells surrounded by a biocompatible cover which allows blood to pass through and enter the cells.

61. A system for delivering a device to within a target atrioventricular valve, the system comprising: a hollow access sheath having a length sufficient to extend from outside the body to the atrioventricular valve; a generally cylindrical spacer at a distal end of the access sheath and configured to expand and coapt against the leaflets of the atrioventricular valve to reduce regurgitation therebetween, the spacer having an internal blood pump system comprising a rigid inner tube surrounded by an inflatable outer skin connected thereto, the inner tube defining an inner chamber that receives a plunger that may be displaced axially via the access sheath, the inner tube also having an inlet valve open to an external environment and an outlet valve open to a space between the inner tube and the outer skin, wherein reciprocating movement of the plunger alternately opens and closes the valves to pull blood in through the inlet valve and transfer it to the space to inflate the spacer; anda plurality of supra-annular anchoring arms connected to and extending outward at an angle from a proximal end of the spacer such that the device may be anchored to the annulus with the spacer suspended between the leaflets.

62. The system of claim 61, wherein the plunger is rigidly connected to a threaded actuator at a proximal end of the spacer which may be engaged via the access sheath to axially displace the plunger.

63. The system of claim 61, further including a fluid conduit extending through the access sheath and open to the space, wherein saline may be injected or removed through the fluid conduit to test the efficacy of the spacer in reducing regurgitation.

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