WO2025193713A1 - Implants for improving atrial compliance - Google Patents

Abstract

Disclosed herein are devices and methods for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. The disclosed technologies decrease the temporal increase in blood flow and pressure into the heart from the venous system (which drains from the body). Under exertion, there is a shift of blood from the 'unstressed' reservoir of vasculature to the 'stressed' reservoir. By inhibiting this acute shift of blood from the unstressed reservoir to the stressed reservoir, an undesirable influx of blood volume to the already overloaded left heart can be avoided. Certain embodiments provide ways to maintain or to increase atrial elasticity, or atrial compliance using devices implanted in the left atrium and/or left atrial appendage. This increase or enhancement of atrial compliance enables the atrium to absorb the energy of short bursts of high left atrial pressure.

Description

IMPLANTS FOR IMPROVING ATRIAL COMPLIANCE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63/565,917, filed March 17, 2024, the complete disclosure of which is hereby incorporated by reference in its entirety.

BACKGROUND

Field

[0002] The present disclosure relates to devices and methods that address elevated left-sided filling pressures in the heart.

Description of the Related Art

[0003] The heart is a pump composed of four chambers. It is divided in the middle into a right and left side, and each side is divided further into two chambers — the upper chambers, called the atria, and the lower chambers, called the ventricles. The atria receive the blood that is entering the heart, and the ventricles pump the blood out of the heart. A cardiac cycle refers to the heart repeatedly contracting and then relaxing to pump the blood around the body. The cardiac cycle begins when the two atria contract, pushing blood into the ventricles. Then, the ventricles contract, forcing blood out of the heart. Diastole refers to the portion of the cardiac cycle when the heart muscle relaxes and the chambers of the heart fill with blood. Systole refers to the portion of the cardiac cycle when the heart muscle contracts, pushing blood out of the heart and into the large blood vessels of the circulatory system.

[0004] Diastolic dysfunction refers to a problem with diastole. In particular, diastolic dysfunction occurs when the lower heart chambers fail to relax as they typically do. As a result, the ventricles do not fill with blood as they should, and a subject may experience pressure buildup in their heart. This may result in fluid buildup in the lungs, abdomen, and legs and may progress to diastolic heart failure.

SUMMARY

[0005] Described herein are methods and/or devices that provide a variety of ways to inhibit or prevent backward propagation of elevated pressures from the left heart to the pulmonary vasculature. The methods and/or devices are configured to reduce blood flow into the heart and lungs. [0006] Described herein are methods and/or devices that provide a variety of ways to inhibit or prevent backward propagation of elevated pressures from the left heart to the pulmonary vasculature. The methods and/or devices are configured to enhance atrial compliance to handle temporal increases in left atrial pressure. The methods and/or devices can include one or more components implanted in the left atrial appendage.

[0007] In some aspects, the techniques described herein relate to an implant adapted for deployment in a left atrial appendage. The implant includes a proximal frame portion; a distal frame portion; and a cover extending along the proximal frame portion and the distal frame portion, the cover providing a seal at a distal end of the distal frame portion for preventing blood from passing through the implant. The distal frame portion has a smaller diameter than the proximal frame portion. The distal frame portion is adapted to expand during atrial systole and to contract during atrial diastole for enhancing compliance of a left atrium, thereby improving heart function.

[0008] In some implementations, the proximal frame portion is sized to anchor the implant at an ostium of the left atrial appendage.

|0009| In some implementations, the distal frame portion has an oval cross-section in a contracted state. In some implementations, the distal frame portion has a concave surface before deployment in the left atrial appendage. In some implementations, the distal frame portion has a substantially peanut shaped cross-section before deployment in the left atrial appendage.

[0010] In some implementations, the seal is flexible for enhancing compliance of the left atrium during atrial systole. In some implementations, the seal is adapted to move proximally to enhance blood washout from an interior of the implant during atrial diastole.

[0011] In some implementations, the cover couples the proximal frame portion to the distal frame portion. In some implementations, the proximal frame portion and the distal frame portion are formed from Nitinol. In some implementations, the proximal frame portion and the distal frame portion are made from a braided, self-expanding material.

[0012] In some implementations, the proximal frame portion and the distal frame portion are made from different materials. In some implementations, the proximal frame portion radially expands to a substantially circular cross-section during diastole.

[0013] In some implementations, the cover is made from Dacron.

[0014] In some implementations, the implant is collapsible for advancement into the left atrial appendage via a catheterization technique. In some implementations, a catheter is provided for delivering the implant, the catheter having a length sufficient to advance the implant through a patient’s vasculature, into a right atrium, and across an atrial septum to the left atrial appendage.

[0015] In some aspects, the techniques described herein relate to an elastic appendage configured to be implanted in a left atrial appendage of a patient, the elastic appendage including: a frame forming an annulus at a proximal end; a first membrane coupled to the annulus formed by the frame; and a second membrane coupled to the frame, wherein the frame is configured to be shaped to fill a space in the left atrial appendage of the patient, wherein, in a deployed configuration, the first membrane is configured to be substantially flush with the annulus formed by the frame responsive to low left atrial pressures, and wherein, in the deployed configuration, the first membrane is configured to deflect into a cavity formed by the frame and the second membrane responsive to high left atrial pressures to enhance atrial compliance.

[0016] In some aspects, the techniques described herein relate to an elastic appendage, wherein the first membrane and the second membrane form a fluid-tight seal.

[0017] In some aspects, the techniques described herein relate to an elastic appendage, wherein a cavity formed by the first membrane and the second membrane contains a fluid under an internal pressure.

[0018] In some aspects, the techniques described herein relate to an elastic appendage, wherein the internal pressure is greater than the low left atrial pressures and less than the high left atrial pressures.

[0019] In some aspects, the techniques described herein relate to an elastic appendage, wherein the frame is external to the second membrane.

[0020] In some aspects, the techniques described herein relate to an elastic appendage, wherein the second membrane includes a non-compliant material.

[0021] In some aspects, the techniques described herein relate to an elastic appendage further including a plurality of barbs at the proximal end of the frame, the plurality of barbs configured to anchor the elastic appendage at an ostium of the left atrial appendage.

[0022] In some aspects, the techniques described herein relate to an elastic appendage, wherein the frame is internal to the second membrane.

[0023] In some aspects, the techniques described herein relate to an elastic appendage, wherein the second membrane includes a compliant material.

[0024] In some aspects, the techniques described herein relate to an elastic appendage, wherein the second membrane is configured to bulge outward responsive to the high left atrial pressures. [0025] In some aspects, the techniques described herein relate to a powered left atrial appendage (LAA) pump including: a pump configured to be implanted in a left atrial appendage of a patient, the pump including a frame with a sealing cover and an active element that forms a pump, the active element housed within the frame; a power source external to a heart of the patient; and an electrical lead electrically coupling the active element to the power source, wherein the pump is configured to displace blood from the LAA into a left atrium during atrial systole to augment an atrial kick to enhance left ventricular filling.

[0026] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the active element includes a balloon, a movable membrane, a plunger, or a piston.

[0027] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the electrical lead includes a pressure sensor configured to provide feedback for controlling timing of activation of the pump.

[0028] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the pump is configured to displace blood from the LAA to the left atrium responsive to a mean internal cavity pressure of the left atrium exceeds 15 mmHg.

[0029] In some aspects, the techniques described herein relate to a powered LAA pump, wherein a volume of blood displaced by the pump is configured to be greater than about 15 mL.

[0030] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the volume of blood displaced by the pump is configured to be less than about 30 mL.

[0031] In some aspects, the techniques described herein relate to a powered LAA pump, wherein a shape of the pump is configured to change responsive to energy provided by the power source.

[0032] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the frame includes a shape memory alloy and application of power from the power source causes the frame to change the shape of the pump.

[0033] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the active element includes an element that uses pneumatics to activate.

[0034] In some aspects, the techniques described herein relate to a powered LAA pump, wherein the pump is configured to increase an A wave and to reduce a V wave. [0035] In some aspects, the techniques described herein relate to a left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant including: a compliant membrane; and a frame coupled to the compliant membrane at a proximal end of the frame, the frame forming an oblong shape suitable for implanting in the LAA of a patient, wherein the compliant membrane is configured to effectively smooth an inner surface of the LAA, wherein the compliant membrane is configured to provide a pressure-mediated radial expansion of the compliant membrane during atrial filling, wherein the compliant membrane is configured to assist in ejection of blood from the LAA to a left atrium during left atrium systole.

[0036] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to cover the frame that extends from an ostium of the LAA to a neck of the LAA.

[0037] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to be positioned at an ostium of the LAA.

[0038] In some aspects, the techniques described herein relate to a LAA implant, wherein the LAA implant is configured to displace volume to increase compliance, thereby decreasing pressure in the left atrium.

[0039] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to bulge inward to allow blood to occupy a portion of the LAA within the frame responsive to elevated left atrial pressures.

[0040] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to return to an ostium to expel blood from the LAA responsive to reduced left atrial pressures.

[0041] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to be sufficiently compliant such that the compliant membrane deforms to approach a distal end of the frame responsive to increasing left atrial pressures.

[0042] In some aspects, the techniques described herein relate to a LAA implant, wherein an amount of deflection of the compliant membrane is configured to be correlated with pressure in the left atrium.

[0043] In some aspects, the techniques described herein relate to a LAA implant, wherein the frame includes a shape memory alloy that is configured to be crimped during delivery and to self-expand upon deployment. [0044] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to be impervious to liquid.

[0045] In some aspects, the techniques described herein relate to a left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant including: a compliant membrane; and an annular frame portion coupled to the compliant membrane, the annular frame portion configured to be anchored at an ostium of the LAA of a patient, wherein the compliant membrane is configured to provide a pressure-mediated radial expansion of the compliant membrane during atrial filling, wherein the compliant membrane is configured to assist in ejection of blood from the LAA to a left atrium during left atrium systole.

[0046] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to bulge inward into the LAA responsive to high left atrial pressures.

[0047] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to return to the ostium after bulging inward into the LAA responsive to low left atrial pressures to assist in the ejection of blood from the LAA.

[0048] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to occlude the LAA.

[0049] In some aspects, the techniques described herein relate to a LAA implant, wherein the annular frame includes anchoring features to anchor securely to the ostium of the LAA.

[0050] In some aspects, the techniques described herein relate to a left atrial appendage (LAA) compliance ballon configured to be implanted in the LAA to assist with filling and expelling of blood from the LAA, the LAA compliance balloon including: a balloon configured to be positioned in the LAA; and a tether coupled to the balloon, the tether configured to power the balloon to inflate and deflate the balloon, wherein during atrial diastole, the tether delivers power to the balloon to deflate the ballon to allow blood in the LAA, and wherein in atrial systole, the tether delivers power to the balloon to inflate the balloon to expel blood from the LAA.

[0051] In some aspects, the techniques described herein relate to a LAA compliance balloon, wherein the tether is coupled to a fluid reservoir that is activated passively by hemodynamic pressures to inflate the balloon. [0052] In some aspects, the techniques described herein relate to a LAA compliance balloon, wherein the tether is coupled to a battery to power the balloon.

[0053] In some aspects, the techniques described herein relate to a LAA compliance balloon, wherein the balloon is configured to inflate and deflate via deformation of internal structures.

[0054] In some aspects, the techniques described herein relate to a LAA compliance balloon, wherein inflation and deflation of the balloon is activated by intracardiac pressures.

[0055] In some aspects, the techniques described herein relate to an elastic appendage configured to be implanted in a left atrial appendage (LAA) of a patient, the elastic appendage including: a frame forming an annulus at a proximal end; an elastic annulus coupled to the annulus formed by the frame; a plurality of panels coupled to the elastic annulus; a central support hub coupled to the plurality of panels, the central support hub, the plurality of panels, and the elastic annulus forming a first membrane at the proximal end of the frame; a second membrane coupled to the frame, the first membrane, the second membrane, and the frame forming a cavity within the frame; a spring housing within the cavity; a spring housed within the spring housing; and a rod having a proximal end coupled to the central support hub and a distal end within the spring housing and in contact with the spring, wherein the frame is configured to be shaped to fill a space in the left atrial appendage of the patient, wherein, in a deployed configuration, the first membrane is configured to be at or near the annulus formed by the frame responsive to low left atrial pressures due at least in part to the spring pushing the rod proximally cause the central hub support, the plurality of panels, and the elastic annulus to be at or near the proximal end of the frame, and wherein, in the deployed configuration, the first membrane is configured to inwardly deflect into a cavity formed by the frame and the second membrane responsive to high left atrial pressures to enhance atrial compliance, the high left atrial pressures pushing distally on the plurality of panels and the elastic annulus which pushes the rod distally to compress the spring to regulate inward deflection of the first membrane.

[0056] In some aspects, the techniques described herein relate to an elastic appendage, wherein the frame is within the second membrane.

[0057] In some aspects, the techniques described herein relate to an elastic appendage, wherein the second membrane is within the frame.

[0058] In some aspects, the techniques described herein relate to an elastic appendage, wherein the second membrane is configured to be non-compliant. [0059] In some aspects, the techniques described herein relate to an elastic appendage, wherein the plurality of panels is rigid.

[0060] In some aspects, the techniques described herein relate to an elastic appendage, wherein the rod forms a plunger at the distal end of the rod.

[0061] In some aspects, the techniques described herein relate to an elastic appendage, wherein the plurality of panels is rigid.

[0062] In some aspects, the techniques described herein relate to a sequential balloon pump including: a multi-segment balloon including a plurality of segments that can be inflated individually, the multi-segment balloon configured to be implanted in a left atrium; a power source; a lead coupled to the power source and to the multi-segment balloon, the lead configured to provide power from the power source to the multi-segment balloon, wherein the multi-segment balloon is configured to inflate and deflate as activated by the power source to enhance atrial compliance.

[0063] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the plurality of segments of the multi-segment balloon are configured to be inflated sequentially in an inflation order.

[0064] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the plurality of segments of the multi-segment balloon are configured to be deflated sequentially in a deflation order.

[0065] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the deflation order of the plurality of segments of the multi-segment balloon is identical to the inflation order.

[0066] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the inflation order is configured to propel blood from a roof of the left atrium toward a mitral annulus and into a left ventricle.

[0067] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the deflation order is configured to suck in blood from a pulmonary veins and lungs to fill the left atrium for a subsequent cardiac beat.

[0068] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the multi-segment balloon is configured to inflate beginning with a segment of the plurality of segments that is adjacent to a roof of the left atrium.

[0069] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the multi-segment balloon is configured to deflate beginning with a segment of the plurality of segments that is adjacent to a roof of the left atrium. [0070] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the multi-segment balloon is configured to expand and contract in response to energy received from the power source.

[0071] In some aspects, the techniques described herein relate to a sequential balloon pump further including a pressure element configured to provide pressure measurements, the pressure measurements used to time operation of the sequential balloon pump.

[0072] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the multi-segment balloon is inflated responsive to a mean internal cavity pressure of the left atrium exceeding a threshold value.

[0073] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the threshold value is about 15 mmHg.

[0074] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein a volume displaced by the multi-segment balloon is at least 10 mL.

[0075] In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the power source is implanted in a left atrial appendage.

|0076| In some aspects, the techniques described herein relate to a sequential balloon pump, wherein the multi-segment balloon includes at least 3 segments.

[0077] In some aspects, the techniques described herein relate to a left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant including: a support structure configured to be implanted in a native appendage; a compliant membrane coupled to the support structure; and a sealing skirt coupled to the support structure, wherein the sealing skirt is configured to prevent blood from entering the native appendage, wherein the compliant membrane is configured to respond to blood flow to ensure occlusion of the native appendage is effect and to assist with regulation of blood flow, wherein the compliant membrane is configured to provide a pressure-mediated radial expansion of the compliant membrane during atrial filling, wherein the compliant membrane is configured to assist in ejection of blood from the LAA to a left atrium during left atrium systole.

[0078] In some aspects, the techniques described herein relate to a LAA implant, wherein the support structure is configured to be anchored at an ostium of the LAA of a patient.

[0079] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to bulge inward into the LAA responsive to high left atrial pressures. [0080] In some aspects, the techniques described herein relate to a LAA implant, wherein the compliant membrane is configured to return to the ostium after bulging inward into the LAA responsive to low left atrial pressures to assist in the ejection of blood from the LAA.

[0081] In some aspects, the techniques described herein relate to a LAA implant, wherein a combination of the sealing skirt and the compliant membrane is configured to occlude the LAA.

[0082] In some aspects, the techniques described herein relate to a LAA implant, wherein the support structure includes anchoring features to anchor securely to the ostium of the LAA.

[0083] In some aspects, the techniques described herein relate to an anti-clot pocket for implantation in a left atrial appendage (LAA) of a patient, the anti-clot pocket including: a frame including a plurality of frame members; and a sealing membrane, wherein the frame is configured to change shape during systole and diastole, wherein the frame is biased in a peanut shape such that responsive to an increase in pressure, the frame changes to a more oval shape to enhance atrial compliance.

[0084] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein the frame further includes barbs to facilitate implantation in the LAA.

[0085] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein, responsive to changes in pressure, the pocket changes shape to provide compliance and to enhance blood washout.

[0086] In some aspects, the techniques described herein relate to an anti-clot pocket for implantation in a left atrial appendage (LAA) of a patient, the anti-clot pocket including: a fixation frame; an oval stent; a tapered portion coupling the fixation frame to the oval stent; and a distal sealing membrane coupled to a distal end of the oval stent; and a non-porous cover coupled to the fixation frame, the tapered portion, and the oval stent, wherein the fixation frame and the oval stent are configured to change shape during systole and diastole, wherein the fixation frame and the oval stent are biased in a peanut shape such that responsive to an increase in pressure, the frame changes to a more oval shape to enhance atrial compliance.

[0087] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein the fixation frame is configured to anchor the anti-clot pocket at the ostia of the LAA. [0088] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein the oval stent further includes anchors to secure the anti-clot pocket in the LAA.

[0089] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein, responsive to an increase in pressure, the distal sealing member is configured to bulge away from the oval stent to enhance compliance.

[0090] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein, responsive to a decrease in pressure, the distal sealing member is configured to relax from a bulged state toward the oval stent to enhance blood washout.

[0091] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein the fixation frame and oval stent include nitinol.

[0092] In some aspects, the techniques described herein relate to an anti-clot pocket, wherein the fixation frame is flared radially relative to a central axis of the anti-clot pocket so as to extend over the LAA ostium.

[0093] In some aspects, the techniques described herein relate to an appendage wedge implant configured to be implanted in a left atrial appendage (LAA) of a patient, the appendage wedge implant including: a cover that defines a proximal opening; a wire spring that presses outward on the cover to define a shape of the proximal opening; and an anchor barb configured to secure the appendage wedge implant to the LAA, wherein during diastole, the proximal opening is pressed into a flat, narrow opening responsive to decreased pressure on the cover such that the wire spring presses outward on the cover, wherein during systole, the proximal opening opens wider responsive to increased pressure pressing the wire spring inward, thereby changing the shape of the opening to be wider.

[0094] In some aspects, the techniques described herein relate to an appendage wedge implant, wherein wire spring is configured to press outward along two edges to cause the appendage wedge implant to flatten at diastolic pressures.

[0095] In some aspects, the techniques described herein relate to an appendage wedge implant, wherein a volumetric change of the appendage wedge implant caused by the wire spring interacting with the cover to change a volume within the cover is configured to increase atrial compliance during a cardiac cycle.

[0096] In some aspects, the techniques described herein relate to an internal compliance assist device configured to implanted within a left atrial appendage (LAA) of a patient, the device including: a C-shaped clip configured for implanting in the LAA, wherein during high pressure, the C-shaped clip is compressed to open the ostium of the LAA, wherein during low pressure, the C-shaped clip presses outward on the LAA to flatten the opening of the LAA.

[0097] In some aspects, the techniques described herein relate to a device, wherein the C-shaped clip is configured to store energy during peak LA pressure and to squeeze during low pressure.

[0098] In some aspects, the techniques described herein relate to a magnetic device configured to be implanted in a left atrial appendage (LAA) of a patient, the device including: a first magnet implanted to a first side of the LAA; and a second magnet implanted to a second side of the LAA, the second side opposite the first side, wherein during atrial diastole, pressure presses apart the first and second magnets, wherein during atrial systole, a drop in pressure causes the first and second magnets to approximate to one another, wherein respective movement of the first and second magnets in combination with magnetic forces between the first and second magnets is configured to enhance atrial compliance and to assist with blood washout.

[0099] In some aspects, the techniques described herein relate to a device further including a stent implanted between the first and second magnets.

[0100] In some aspects, the techniques described herein relate to a device configured to be implanted in a patient to enhance atrial compliance, the device including: a first stent configured to be implanted in a first location in a heart of the patient; and a second stent to be implanted in a second location in the heart of the patient; and a spring that attaches the first stent to the second stent, wherein the spring is configured to elongate and to contract in accordance with pressures during a cardiac cycle to enhance with filling and ejection of blood in the left atrium.

[0101] In some aspects, the techniques described herein relate to a device, wherein the first location is the pulmonary vein and the second location is the left atrium.

[0102] In some aspects, the techniques described herein relate to a device, wherein the first location is a left atrial appendage (LAA) and the second location is a wall of a left atrium (LA) opposite the LAA.

[0103] In some aspects, the techniques described herein relate to a device, wherein the second stent includes an anchor that is attached to the second location.

[0104] In some aspects, the techniques described herein relate to a device, wherein the first stent is an occluder.

[0105] In some aspects, the techniques described herein relate to a device configured to be implanted at a left atrial appendage (LAA) of a patient to enhance atrial compliance, the device including: a membrane that is flexible at its perimeter around an ostium of the LA A, wherein the device is configured to provide in-plane deflection with the membrane during a cardiac cycle by deflecting outwards and in-plane with the LAA ostium.

[0106] In some aspects, the techniques described herein relate to a device, wherein the membrane is configured similar to an atrial wall that stretches in 2 dimensions in plane with the LAA ostium rather than perpendicular to the LAA ostium.

[0107] In some aspects, the techniques described herein relate to a device, wherein the membrane is tied to the ostium

[0108] In some aspects, the techniques described herein relate to a device, wherein the membrane acts as an occluder.

[0109] In some aspects, the techniques described herein relate to a device, wherein the membrane does not deflect in and out of the LAA.

[0110] In some aspects, the techniques described herein relate to a closure device for a left atrial appendage (LAA) of a patient, the closure device including: an expandable cylindrical frame; a first sealed cloth covering a circumference of the expandable cylindrical frame; a second sealed cloth coupled to a distal edge of the expandable cylindrical frame; and a flushing mechanism coupled to a proximal edge of the expandable cylindrical frame, wherein the flushing mechanism is configured to enhance blood flow out of an inner volume of the expandable cylindrical frame.

[0111] In some aspects, the techniques described herein relate to a closure device, wherein the flushing mechanism includes a pair of sails configured to act as a duck bill valve.

[0112] In some aspects, the techniques described herein relate to a closure device, wherein during systole, the pair of sails come closer to each other and flush blood from the inner volume of the expandable cylindrical frame and during diastole, the pair of sails move away from each other and fill the inner volume with blood.

[0113] In some aspects, the techniques described herein relate to a closure device, wherein the pair of sails are fixated at a distal edge and a proximal edge of the expandable cylindrical frame and material of the pair of sails between the distal edge and proximal edge is configured to move and to change shape.

[0114] In some aspects, the techniques described herein relate to a closure device, wherein the flushing mechanism includes: a support rod coupled to a proximal edge of the expandable cylindrical frame and extending toward a distal edge of the expandable cylindrical frame within the inner volume; and a set of flexible membranes coupled to the support rod, each membrane of the set of flexible membranes configured to change geometry during cardiac cycles responsive to pressure changes.

[0115] In some aspects, the techniques described herein relate to a closure device, wherein the change in geometry improves blood flow inside the closure device.

[0116] In some aspects, the techniques described herein relate to a closure device, wherein the inner volume is configured to maintain a blood volume within the LAA and to provide a flushing mechanism for the blood volume to inhibit thrombi formation.

[0117] In some aspects, the techniques described herein relate to a closure device, wherein each membrane includes a nitinol shape set wire, is encapsulated with ePTFE, includes an ePTFE membrane, or includes ePTFE encapsulated Nitinol braid.

[0118] In some aspects, the techniques described herein relate to a closure device, wherein the closure device is configured to reduce a risk of clot formation not by occluding the LAA but by increasing blood flow from and out of the LAA.

[0119] For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0120] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the disclosure. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0121] FIGS. 1A, IB, 1C, and ID illustrate an example of an elastic appendage configured to be implanted in the left atrial appendage (LAA).

101221 FIG. 2 illustrates another example of an elastic appendage configured to be implanted in the LAA.

[0123] FIGS. 3A, 3B, 3C, 3D, 3E, and 3F illustrate an example of a process for implanting the elastic appendage of FIG. 2 in the LAA.

[0124] FIG. 4 illustrates an example of a powered LAA pump configured to be implanted in the LAA. [0125] FIGS. 5A and 5B illustrate an LAA implant that is configured to be implanted in the LAA to enhance atrial compliance.

[0126] FIGS. 6A, 6B, and 6C illustrate an example of an LAA membrane that is configured to be implanted at the ostium of the LAA.

[0127] FIGS. 7A and 7B illustrate an example of an LAA compliance balloon that is configured to be implanted in the LAA to assist with expelling blood from the LAA.

[0128] FIGS. 8A, 8B, and 8C illustrate another example of an elastic appendage configured to be implanted in the LAA, the elastic appendage including a spring-loaded panel to enhance atrial compliance.

[0129] FIGS. 9A, 9B, 9C, and 9D illustrate an example of a sequential balloon pump with a multi-segment balloon coupled to a power source via a lead.

[0130] FIG. 10 illustrates an elastic appendage comprising a sealing skirt and a compliant membrane with a structural frame.

[0131] FIGS. 11A, 11B, 11C, 11D, and HE illustrate an example embodiment of an anti-clot pocket for implantation in the LAA.

|0132| FIGS. 12A, 12B, 12C, 12D, 12E, 12F, 12G, 12H, 121, and 12J illustrate an example of a deformable LAA implant that is configured to enhance atrial compliance.

[0133] FIGS. 13A, 13B, 13C, 13D, 13E, and 13F illustrate an example of a deformable LAA implant with a deformable stent.

[0134] FIGS. 14A, 14B, and 14C illustrate another example of a deformable LAA implant in which a fixation frame and a deformable stent are formed as separate components that are then coupled to each other.

[0135] FIGS. 15A, 15B, 15C, 15D, 15E, 15F, 15G, and 15H illustrate another deformable LAA implant that is adapted to have a significantly longer region of sealing.

[0136] FIGS. 16A, 16B, 16C, 16D, 16E, and 16F illustrate an example of an end- deformable stent that is configured to be implanted in the LAA to enhance atrial compliance.

[0137] FIGS. 17A and 17B illustrate an appendage wedge configured to be implanted in the LAA.

[0138] FIG. 18 illustrates an internal compliance assist device that is configured to store energy during peak LA pressure and to squeeze during low pressure.

[0139] FIGS. 19A, 19B, 19C, 19D, and 19E illustrate a magnetic device configured to enhance compliance of the LA by pressing the walls of the LAA.

[0140] FIGS. 20A, 20B, and 20C illustrate another example device configured to enhance atrial compliance. [0141] FIGS. 21A, 21B, 21C, and 21D illustrate a device configured to provide inplane deflection with a membrane.

[0142] FIGS. 22 A and 22B illustrate an example embodiment of an LAA closure device with a flushing mechanism.

[0143] FIGS. 23 A, 23B, 23C, 23D, 23E, and 23F illustrate another example embodiment of an LAA closure device with a flushing mechanism.

DETAILED DESCRIPTION

[0144] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter.

Overview

[0145] Diastolic dysfunction is a heart condition that happens when there is a “stiffening” of the major pumping chambers of the organ (ventricles). This stiffness impedes the heart’s ability to fill up with blood between heartbeats. Consequently, the heart does not fill up with as much blood as it should and/or the heart pumps out less blood to the rest of the body relative to a healthy heart.

[0146] Diastolic dysfunction of the heart is characterized by high left-sided filling pressures of the left ventricle. In addition, the left atrium has elevated pressures as measured by elevated post capillary wedge pressure (PCWP) both at rest and under exertion. As the left atrial pressure increases, the walls of the left atrium dilate and stretch to a less materially compliant state. In other words, there is a loss of elasticity in the myocardium of the dilated left atrium to absorb temporal increases in left atrial pressure. The net effect is a back-up of flow from the left atrium into the pulmonary veins and subsequently into the capillary bed of the lung parenchyma. This increased pressure in the pulmonary vasculature causes an elution of water into the alveoli of the lungs which is felt as pulmonary congestion and shortness of breath by the patient. Unchecked, diastolic dysfunction can progress to diastolic heart failure.

[0147] Accordingly, disclosed herein are devices and methods for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. Various embodiments provide ways to decrease the temporal increase in blood flow and pressure into the heart from the venous system (which drains from the body). Under exertion, there is a shift of blood from the ‘unstressed’ reservoir of vasculature, which primarily comprises the splanchnic system (e.g., liver, spleen, gut), to the ‘stressed’ reservoir, which comprises the heart and lungs. By inhibiting or preventing this acute shifting of blood from the ‘unstressed’ reservoir to the ‘stressed’ reservoir, an undesirable influx of blood volume to the already overloaded left heart can be avoided. Certain embodiments provide ways to maintain, enhance, or increase atrial compliance, or atrial elasticity. This increase or enhancement of atrial compliance enables the atrium to ‘absorb’ the energy of short bursts of high left atrial pressure. Consequences of such embodiments are a reduction in the retrograde flow in the pulmonary veins to inhibit or prevent acute pulmonary congestion.

[0148] The technologies disclosed herein provide a variety of ways to inhibit or prevent backward propagation of elevated pressures from the left heart to the pulmonary vasculature. This can be achieved by enhancing atrial compliance to handle temporal increases in left atrial pressure. The disclosed technologies implement a variety of devices and systems that use the left atrial appendage (LAA) to enhance atrial compliance. Examples of these technologies include balloons and balloon pumps, LAA occluders with compliant membranes, stents with flexible components implanted in the LAA, compliant materials implanted in the LAA, diaphragms that flex into the LAA, and the like that use the LAA in some way to add compliance to the left heart during filling and emptying.

|0149| Advantageously, enhancing compliance of the left atrium can inhibit or prevent adverse effects due to diastolic dysfunction. For example, diastolic dysfunction can reduce compliance of the left atrium, meaning that there is a reduction in pressure for the same volume in the left atrium. The patient can experience elevated left atrial pressure (associated with many negative symptoms and a poor prognosis) which may progress to heart failure. Increasing or enhancing atrial compliance results in the atrium accepting more blood which may lead to beneficial results, such as a reduction in transmission back to the lungs.

[0150] In some embodiments, the disclosed technologies can be used as an alternative to shunting the left atrium. This may be beneficial because it does not introduce oxygenated blood to the left atrium.

[0151] In some embodiments, the disclosed technologies are configured to react to pressures and/or pressure differentials between in the heart. By way of reference, a typical cardiac cycle results in the removal of about 14 mL to about 18 mL of blood per heartbeat. Accordingly, to provide a clinically significant pressure drop, the disclosed technologies can be configured to provide a similar volume removal. For example, devices implanted in the left atrial appendage (LAA) can be configured to remove a targeted range of volume removal (e.g., about 14 mL-18 mL). Elastic appendage within the left atrial appendage

[0152] FIGS. 1A, IB, 1C, and ID illustrate an example of an elastic appendage configured to be implanted in the LAA 16. FIGS. 1A and IB illustrate a first implementation of an elastic appendage 140a and FIGS. 1C and ID illustrate a second implementation of an elastic appendage 140b.

[0153] With reference to FIGS. 1A and IB, the elastic appendage 140a includes a first membrane 142, a second membrane 144, and a frame 146 coupled to the first membrane 142 and to the second membrane 144, wherein the frame 146 is within the second membrane 144. With reference to FIGS. 1C and ID, the elastic appendage 140b includes the first membrane 142, the second membrane 144, and the frame 146 coupled to the first membrane 142 and to the second membrane 144, wherein the frame 146 is external to the second membrane 144. The internal cavity formed by the first membrane 142, the second membrane 144 and the frame 146 can be filled with a low-pressure gas or fluid. For the elastic appendages 140a, 140b, both the first membrane 142 and the second membrane 144 are configured to be compliant. In some implementations, the first membrane 142 is configured to be softer or more compliant than the second membrane 144. In some implementations, the first membrane 142 is compliant and the second membrane 144 is non-compliant in which case the frame 146 is external to the second membrane 144. For the first membrane 142 and the second membrane 144, the materials can be any suitable hyperelastic and/or compliant materials such as thin silicon rubber. In addition, the frame 146 can be any suitable material including, for example, a shape memory alloy such as Nitinol. The frame 146 can form an annulus at a proximal end of the elastic appendages 140a, 140b, the annulus configured to support the first membrane 142 in such a way that the first membrane 142 is free to extend into the cavity formed by the second membrane 144 and the frame 146. This is illustrated in FIGS. IB and ID, for example.

[0154] FIGS. 1A and 1C illustrate the elastic appendages 140a, 140b in the condition of low left atrial pressure. In this condition, the first membrane 142 can be flush or flat with the annulus formed by the frame 146. In some implementations, the first membrane 142 is configured to partially deform into the space formed by the second membrane 144 and the frame 146 in the condition of low left atrial pressure. In such embodiments, the first membrane 142 is configured to more fully deform into the space formed by the second membrane 144 and the frame 146 in the condition of high left atrial pressure.

[0155] FIGS. IB and ID illustrate the elastic appendages 140a, 140b in the condition of high left atrial pressure. In this condition, the first membrane 142 deforms into the space formed by the second membrane 144 and the frame 146 while the second membrane 144 bulges radially to allow the first membrane 142 to deform more. In implementations where the second membrane 144 includes a non-compliant material, the first membrane 142 is adapted to deflect into the cavity under high left atrial pressure and the second membrane 144 is adapted to not move or bulge outward.

[0156] The elastic appendages 140a, 140b are configured to be delivered via a transcatheter delivery system that crosses the interatrial septum and is advanced into the distal pocket of the LAA 16. The delivery catheter is retracted and the elastic appendage 140a, 140b self-expands to occupy the volume of the LAA 16. The delivery catheter is then removed from the body.

[0157] The frame 146 can be a self-expanding frame structure. In some implementations, the frame 146 can be in the shape of an oblong volume with one end being flat (enface), round or circular in cross-section to conform to the ostium of the LAA 16 and the other end tapering to a blunted point. In some implementations, the frame 146 comprises a number of tines (e.g., between about 4 tolO tines) that span the length of the elastic appendage 140a, 140b in a curved geometry and terminates to a common, blunted point. This point can be configured to be near the deepest point in the LAA 16. The proximal ends of the tines attach to a ring formed from the shape memory material of the frame 146. There can also be one or more rings along the length of the frame 146, circling the tines, to enhance the structure of the frame 146. Additionally, the frame 146 can have barbs or features to anchor the assembly into the LAA once delivered.

[0158] The first membrane 142 is configured to be impenetrable to gas and fluid (e.g., air and saline) and to cover the flat end of the frame 146. The second membrane 144 is configured to be less elastic (or more stiff) relative to the first membrane 142. The second membrane 144 is also configured to be impenetrable to gas and fluid (e.g., air and saline). The second membrane 144 is configured to wrap around the circumference of the frame 146 and to extend from the flat end to the blunted tapered end, creating a pocket and sealing in the fluid (e.g., gas or liquid). In some implementations, on the outer circumference of the flat end of the elastic appendage 140a, 140b is a fabric that is configured to seal to the ostium of the LAA and to promote endothelialization.

[0159] Because the first membrane 142 and the second membrane 144 are configured to seal in the fluid, inward movement of the first membrane 142 causes the second membrane 144 to radially bulge. This interaction between the first membrane 142 and the second membrane 144 enables the elastic appendage 140a, 140b to handle temporal increases in pressure. This is accomplished by damping the increases in pressure by allowing blood to occupy a larger volume. An advantage of the elastic appendages 140a, 140b is that the frame 146 is agnostic to different shapes of the LAA 16 found in patients.

[0160] The elastic appendages 140a, 140b include a flexible membrane (the first membrane 142) attached to a rim of the frame 146 (e.g., a proximal annular portion of the frame 146). The elastic appendages 140a, 140b are filled with a compressible fluid (e.g., a liquid or gas). This allows the first membrane 142 to move into and away from the left atrium in response to changes in left atrial pressure. The support structure of the elastic appendages 140a, 140b can be in the form of a covered stent (where the stent is the frame 146 and the cover is the second membrane 144) or a support that supports a pocket-shaped balloon (where the support is the frame 146 and the balloon is the second membrane 144). The volume between the second membrane 144 and the frame 146 is filled with gas or liquid. The first membrane 142 and the second membrane 144 provide compliance to fill during systole and to empty during diastole. In certain instances, the second membrane 144 is over-sized within the LAA 16 to gain additional volume.

101611 In some implementations, the first membrane 142 can extend into the left atrium to add an atrial kick to force blood into the left ventricle. The first membrane 142 can extend inward and outward with the natural systole and diastole strokes. This advantageously adds new volume to the system for enabling a pressure drop. The two-way volume expansion and deflation can be accomplished using a soft membrane for controlling the pressure buildup profile and peak values. Thus, the first membrane 142 deflects into the left atrium as well as the LAA 16. That is, the first membrane 142 can be configured to deflect past the ostia plane into the left atrium.

[0162] During systole, the first membrane 142 expands inwards (e.g., towards the cavity formed by the frame 146) with the pressure vector to fill the volume of the expanded LAA 16. This creates a pressure drop during the peak of the systole since a new volume is added to the system. During diastole, the first membrane 142 changes direction and expands towards the left atrium. The volume of the left atrium is now reduced and the pressure momentarily rises. By tailoring the geometry and thickness of the first membrane 142, the pressure value that causes the change in direction can be controlled. In some implementations, spring-loaded struts can be added to the support the device structure and dynamics.

[0163] FIG. 2 illustrates another example of an elastic appendage 240 configured to be implanted in the LAA 16. Similar to the elastic appendage 140b, the elastic appendage 240 includes a first membrane 242, a second membrane 244, and a frame 246 coupled to the first membrane 242 and to the second membrane 244, wherein the frame 246 is within the second membrane 244. The frame 246 includes a plurality of barbs 241 or anchors configured to anchor the elastic appendage 240 within the LAA 16, e.g., at or near the ostium. The internal cavity formed by the first membrane 242, the second membrane 244, and the frame 246 can be filled with a low-pressure gas or liquid. Both the first membrane 242 and the second membrane 244 are configured to be compliant. In some implementations, the first membrane 242 is configured to be softer or more compliant than the second membrane 244. In some implementations, the first membrane 242 is compliant and the second membrane 244 is non- compliant in which case the frame 246 is external to the second membrane 244. For both the first membrane 242 and the second membrane 244, the materials can be any suitable hyperelastic and/or compliant materials such as thin silicon rubber. In addition, the frame 246 can be any suitable material including, for example, a shape memory alloy such as Nitinol. The frame 246 can form an annulus at a proximal end of the elastic appendage 240, the annulus configured to support the first membrane 242 in such a way that the first membrane 242 is free to extend into the cavity formed by the second membrane 244 and the frame 246.

[0164] FIGS. 3A, 3B, 3C, 3D, 3E, and 3F illustrate an example of a process for implanting the elastic appendage 240 of FIG. 2 in the LAA 16. FIG. 3A illustrates a delivery catheter 310 that is advanced across the interatrial septum to the ostium of the LAA 16. The elastic appendage 240 is delivered in a delivery configuration in which the frame 246 and the second membrane 244 are crimped down to fit within the delivery catheter 310.

[0165] FIG. 3B illustrates an internal catheter 312 that pushes the elastic appendage 240 out of the delivery catheter 310 to transition the elastic appendage 240 from the delivery configuration to a deployed configuration. The frame 246 is configured to expand upon being pushed out of the delivery catheter 310. For example, the frame 246 can be a wireframe comprising a shape memory alloy, such as Nitinol. As the frame 246 expands, the second membrane 244 expands as well due at least in part to the second membrane 244 being coupled to the frame 246.

[0166] FIG. 3C illustrates the elastic appendage 240 being fully expelled from the delivery catheter 310 by the internal catheter 312. This releases the plurality of barbs 241 at the proximal end of the elastic appendage 240, the plurality of barbs 241 being coupled to the frame 246. The frame 246 continues to expand to fill the space in the LAA 16. In some implementations, the internal catheter 312 can be configured to inflate the second membrane 244 with a fluid, such as a liquid or gas. After expelling the elastic appendage 240, the delivery catheter 310 can begin to be withdrawn.

[0167] FIG. 3D illustrates that the elastic appendage 240 is released from the internal catheter 312 and the delivery catheter 310 is withdrawn. The plurality of barbs 241 are configured to anchor to the LAA 16 to secure the elastic appendage 240 within the LAA 16.

[0168] Once implanted or deployed, the elastic appendage 240 is configured to enhance atrial compliance by allowing the first membrane 242 to deflect into the cavity under high pressure and to remain substantially flat under low pressure. In some implementations, the pressure of the fluid within the cavity can be configured to cause the first membrane 242 to deflect into the left atrium under low pressure.

[0169] FIG. 3E illustrates an example of the elastic appendage 240 in a situation in which there is relatively low left atrial pressure (e.g., the internal pressure of the elastic appendage 240 is greater than or equal to the left atrial pressure). The pressure of the fluid within the elastic appendage 240 pushes the first membrane 242 to be substantially flat and even with the annulus formed by the frame 246. In some implementations, responsive to low atrial pressure, the first membrane can extend into the left atrium to provide an atrial kick to help push blood to the ventricle.

[0170] FIG. 3F illustrates the elastic appendage 240 in a situation in which there is a higher left atrial pressure than the internal pressure of the fluid within the cavity of the elastic appendage 240. In this situation, the first membrane 242 deflects into the cavity formed by the second membrane 244 and the frame 246. As described herein, this deflection enhances left atrial compliance to address issues arising from elevated left atrial filling pressures. Advantageously, this can mitigate the effects of diastolic dysfunction.

Powered LAA pump

[0171] FIG. 4 illustrates an example of a powered LAA pump 440 configured to be implanted in the LAA 16. The powered LAA pump 440 includes an active element 442 tethered to a power source 448 via an electrical lead 446. The powered LAA pump 440 can be configured similar to an LAA occluder device with added functionality provided by the active element 442. In some implementations, the active element 442 comprises flexible or movable element, such as a plunger or a balloon.

[0172] The powered LAA pump 440 can be implanted using a transseptal approach to implant the powered LAA pump 440 in the LAA 16. The electrical lead 446 can be directed out of the LAA 16 to the power source 448. The power source 448 can be placed within the subcutaneous space, the electrical lead 446 being routed through venous access and a transseptal puncture.

[0173] The powered LAA pump 440 includes a frame (e.g., a Nitinol wire cage) with a sealing cover, forming a pump. Inside the frame is the active element 442, (e.g. a balloon, a movable membrane, a plunger, a piston, etc.) that is configured to displace blood from the LAA 16 into the left atrium during atrial systole. This augments the atrial kick or A wave pressure to enhance left ventricular filling. In some implementations, the electrical lead 446 includes a pressure sensor that allows for feedback for controlling the timing of activation of the active element 442. In some implementations, the additional atrial kick from the LAA 16 to increase left ventricular filling occurs when the mean internal cavity pressure of the left atrium exceeds a threshold value (e.g., at least about 15 mmHg or between about 10 mmHg and about 20 mmHg). The volume displaced by the powered LAA pump 440 can be between about 15 mL and about 30 mL, based at least in part on the size of the LAA 16.

[0174] The powered LAA pump 440 is configured to increase the A wave and to decrease the V wave of a patient with diastolic dysfunction. Increasing the A wave advantageously increases the volume of blood pushed into the left ventricle and reduces the V wave. By pushing out into the left atrium with the active element 442, the A wave is increased. In addition, the volume available in the left atrium decreases, the compliance of the left atrium is enhanced, and the V wave is decreased. In some implementations, the active element 442 includes an element that uses pneumatics to activate. In some implementations, the shape of the powered LAA pump 440 is affected by application of power, e.g., by way of a shape memory alloy. For example, the shape of the powered LAA pump 440 can be changed from a disk to a rod by application of power to the active element 442 when the active element 442 comprises a shape memory alloy. Other methods can be employed to push a portion of the powered LAA pump 440 out of the LAA 16 such as pushing air to move a piston, changing the shape of wires to change the shape of the powered LAA pump 440, using electromagnets to push a portion of the powered LAA pump 440 out of the LAA 16, etc.

Left atrial appendage implant

[0175] FIGS. 5A and 5B illustrate a passive LAA implant 540 that is configured to be implanted in the LAA 16 by transseptal approach to enhance atrial compliance. The passive LAA implant 540 comprises a compliant elastic material implanted in the LAA 16 to smooth the inner surface of the LAA 16. The shape of the passive LAA implant 540 is adapted to be suitable for particular LAA anatomies and may be ‘finger-like’ in shape, extending from the LAA ostium, into the distal portion of the LAA 16 (or the LAA ‘neck’). The passive LAA implant 540 is configured to improve blood flow efficiency in and out of the LAA 16, which increases the effective compliance of the left atrium and inhibits or prevents thrombus formation within the LAA 16 (where the heterogenous topology of the LAA wall is a contributor to thrombus formation). Additionally, the passive LAA implant 540 may be configured to provide a pressure-mediated radial expansion of the material during atrial filling, resulting in more ejection of blood from the LAA 16 to the left atrium during left atrium systole.

[0176] The passive LAA implant 540 includes a compliant membrane 542 covering a frame 544 that extends from the ostium to the neck of the LAA 16. The compliant membrane 542 is configured to be positioned at or near the ostium of the LAA 16. The passive LAA implant 540 is configured to displace volume to increase compliance, thereby decreasing pressure in the left atrium. As illustrated in FIG. 5B, with elevated pressure (e.g., a pressure above a threshold pressure, such as at least about 15 mmHg or between about 10 mmHg and about 20 mmHg), the compliant membrane 542 bulges inward to allow blood to occupy a portion of the LAA 16 within the confines of the frame 544. As the pressure decreases, the compliant membrane 542 returns to the ostium, thereby expelling blood from the LAA 16. The compliant membrane 542 is attached to the frame 544 at the proximal end of the frame 544, which is configured to be at or near the ostium of the LAA 16. With increase in pressure, the compliant membrane 542 deforms to approach the distal end of the frame 544, effectively increasing the volume of the left atrium as pressure increases. In some implementations, the amount of deflection of the compliant membrane 542 relative to the frame 544 can be correlated with the pressure in the left atrium. In some implementations, the frame 544 comprises a shape memory alloy that is configured to be crimped during delivery and to self-expand upon deployment. In some implementations, the compliant membrane 542 is configured to be impervious to liquid to more efficiently deflect and assist in the ejection of blood from the LAA 16. In some implementations, the frame 544 is configured to be rigid.

[0177] In some implementations, the passive LAA implant 540 includes an annular frame portion (e.g., formed by the frame 544) and a distal frame portion (e.g., the portion of the frame extending distally from the annular frame portion). The distal frame portion is coupled to the annular frame portion to form a cavity into which the compliant membrane 542 can extend. The compliant membrane 542 is coupled to the annular frame portion. The compliant membrane 542 extends into the cavity formed by the distal frame portion to provide a pressure-mediated radial expansion of the compliant membrane during atrial filling. The annular frame portion is configured to anchored at an ostium of the LAA 16. The annular frame portion can include anchoring features to anchor securely to the ostium of the LAA 16.

Left atrial appendage membrane

[0178] FIGS. 6A, 6B, and 6C illustrate an example of an LAA membrane 640 that is configured to be implanted at the ostium of the LAA 16. The LAA membrane 640 includes an annular frame 642, configured to be anchored to the LAA ostium. The annular frame 642 supports a compliant membrane 644. As illustrated in FIG. 6B, an increase in pressure in the left atrium causes the compliant membrane 644 to bulge inward into the LAA 16. In response to a decrease in pressure, the compliant membrane 644 returns to be flush with the annular frame 642, the return to this flush configuration aiding in expelling blood from the LAA 16. The LAA membrane 640 additionally acts to occlude the LAA 16. The annular frame 642 can be configured to include tissue engaging features or a Nitinol frame.

[0179] The LAA membrane 640 is configured to be implanted at the LAA ostium through a transseptal approach. With atrial filling and increasing pressure, the compliant membrane 644 is deformed into the LAA 16, increasing the effective compliance of the left atrium (as the LAA 16 does not adequately contribute to left atrial filling and emptying in patients with left atrial myopathies or atrial fibrillation). When the left atrium is emptying into the left ventricle, and the pressure in the left atrium is decreasing, the compliant membrane 644 is configured to return to its ‘resting’ configuration. The return of the compliant membrane 644 to its resting configuration actively contributes to left atrial systole.

Left atrial appendage compliance balloon

[0180] FIGS. 7A and 7B illustrate an example of an LAA compliance balloon 740 that is configured to be implanted in the LAA 16 to assist with filling and expelling of blood from the LAA 16. The LAA compliance balloon 740 includes a balloon 742 adapted to be positioned within the LAA 16 and a tether 744 that powers the balloon 742. FIG. 7A illustrates that in atrial diastole, the balloon 742 is deflated, allowing blood in the LAA 16. FIG. 7B illustrates that in atrial systole, the balloon 742 inflates, expelling blood from the LAA 16.

[0181] The balloon 742 is placed within the LAA 16, with access achieved through a transseptal approach. The shape of the balloon 742 may vary depending on the anatomy of the LAA 16 of the patient. The balloon 742 is inflated during left atrial systole to eject blood from the LAA 16, as illustrated in FIG. 7B. During atrial diastole, the balloon 742 is deflated, aiding in pulling blood into the LAA 16, as illustrated in FIG. 7A. In patients with left atrial myopathies (often associated with HFpEF and atrial fibrillation), the LAA loss of contractility reduces its active contribution to left atrial compliance. The active expansion and contraction of the LAA compliance balloon 740 increases the compliance of the left atrium during systole and diastole.

101821 The LAA compliance balloon 740 can be powered in several ways. For example, a gas or fluid reservoir that is activated passively by hemodynamic pressures to enlarge the balloon 742 or powered by a power source such as a battery. The tether 744 can be coupled to the gas or fluid reservoir and/or to the power source. This reservoir or power source can implanted either intravascularly, extracorporeal, or subcutaneous (pneumatic operation). The expansion and contraction can also be executed by deformation of internal Nitinol structures, activated by intracardiac pressures or (mechanical operation). In some implementations, inlet and outlet valves can be incorporated to regulate the inflation and deflation of the balloon 742. In some implementations, the tether 744 penetrates the left atrium wall to connect to a reservoir or power source. In some implementations, the reservoir or power source is implanted within the heart so that the tether 744 does not penetrate the left atrium wall.

Spring-loaded panel elastic appendage

[0183] FIGS. 8A, 8B, and 8C illustrate another example of an elastic appendage 840 configured to be implanted in the LAA 16, the elastic appendage 840 including a spring- loaded panel to enhance atrial compliance. Similar to the elastic appendage 140a of FIGS. 1A and IB, the elastic appendage 140b of FIGS. 1C and ID, and the elastic appendage 240 of FIG. 2, the elastic appendage 840 includes a second membrane 844 and a frame 846 coupled to the second membrane 844. The frame 846 can be within the second membrane 844 (similar to the elastic appendage 140a) or external to the second membrane 844 (similar to the elastic appendage 140b, 240). The second membrane 844 is configured to be non-compliant. In some implementations, the elastic annulus 842, the plurality of panels 843, and the central support hub 841 form a structure with functionality similar to the first membrane 142 of the elastic appendages 140a, 140b and/or the first membrane 242 of the elastic appendage 240.

[0184] The frame 846 is configured to form an annulus at a proximal end, the annulus configured to support an elastic annulus 842 coupled to the frame 846. Coupled to the elastic annulus 842 is a plurality of panels 843. The plurality of panels 843 can be rigid or semi- rigid. The plurality of panels 843 is coupled to a rod 845 by way of a central support hub 841. The rod 845 is configured to enter a spring housing 847 that houses a spring 848 that is in contact with a distal end of the rod 845. In some implementations, the distal end of the rod 845 forms a plunger or other enlarged piece to fit snugly within the spring housing 847. The spring housing 847 can thus be configured to guide movement of the rod 845 and to inhibit or prevent the spring 848 from buckling under compression. 0185] FIG. 8B illustrates the elastic appendage 840 under low left atrial pressure. In this situation, the spring 848 pushes the rod 845 proximally so that the elastic annulus 842 and plurality of panels 843 are approximately even with the proximal end of the frame 846. FIG. 8C illustrates the elastic appendage 840 under high left atrial pressure. In this situation, the higher pressure pushes the elastic annulus 842 and the plurality of panels 843 distally, causing the rod 845 to move distally, thereby compressing the spring 848 within the spring housing 847. The compressive force of the spring 848 (e.g., the spring constant) can be configured to resist a targeted low left atrial pressure and to compress a targeted amount in response to a targeted high left atrial pressure. This can be done to enhance atrial compliance to address issues related to high left-sided filling pressures. Advantageously, this can mitigate at least some of the effects of diastolic dysfunction.

[0186] In some implementations, the frame 846 includes a plurality of barbs configured to anchor the elastic appendage 840 within the LAA 16, e.g., at or near the ostium. The internal cavity formed by the first membrane (comprising the central support hub 841, the elastic annulus 842, and the plurality of panels 843), the second membrane 844, and the frame 846 can be filled with a low-pressure gas or liquid. For the elastic annulus 842, the material can be any suitable hyperelastic and/or compliant materials such as thin silicon rubber. In addition, the frame 846 can be any suitable material including, for example, a shape memory alloy such as Nitinol. The frame 846 can form an annulus at a proximal end of the elastic appendage 840, the annulus configured to support the elastic annulus 842 in such a way that the first membrane is free to extend into the cavity formed by the second membrane 844 and the frame 846.

Active left atrial sequential balloon pump

[0187] FIGS. 9A, 9B, 9C, and 9D illustrate an example of a sequential balloon pump 940 with a multi-segment balloon 942 coupled to a power source 944 via a lead 946. The power source 944 is illustrated as being implanted in the LAA 16, but the power source 944 can be implanted elsewhere. [0188] The sequential balloon pump 940 includes the multi-segment balloon 942 that is configured to inflate segmentally in order of segments 1, 2, 3, 4 to propel blood from the left atrium roof (near the pulmonary vein ostium) toward the mitral annulus and into the left ventricle. That is, segment 1 of the multi-segment balloon 942 inflates (as seen in FIG. 9A), then segment 2 of the multi-segment balloon 942 inflates (as seen in FIG. 9B), then segment 3 of the multi-segment balloon 942 inflates (as seen in FIG. 9C), and then segment 4 of the multi-segment balloon 942 inflates (as seen in FIG. 9D). Additionally, the multi-segment balloon 942 is configured to deflate in the same order, that is segment 1 deflates, then segment 2 deflates, and so forth. The sequential balloon pump 940 can include an inflatable balloon (the multi-segment balloon 942) or a shaped nitinol structure in place of the multisegment balloon 942 that can expand and contract as a result of application of active energy (e.g., using the power source 944).

[0189] The sequential balloon pump 940 is configured to augment atrial kick during atrial systole to increase left ventricle filling. In some implementations, a pressure element can be incorporated to time the operation of the sequential balloon pump 940 so that the sequential balloon pump 940 can activate when the mean internal cavity pressure of the left atrium exceeds a threshold value (e.g., at least about 15 mmHg or between about 10 mmHg and about 20 mmHg). The volume displaced by the sequential balloon pump 940 can be configured to be on the order of about 10 mL to about 100 mL, based in part on the size of the left atrium of the patient. In addition, the sequential balloon pump 940 can be configured so that during deflation of the multi-segment balloon 942 blood from the pulmonary veins and lungs is sucked in to fill the left atrium for the next cardiac beat.

[0190] In some implementations, there are a different number of segments in the multi-segment balloon 942. For example, the multi-segment balloon 942 can include at least 2 segments, at least 3 segments, at least 5 segments, at least 6 segments, and/or less than or equal to 10 segments, etc. In some implementations, all of the required electronics and power are housed inside a housing that occupies the LAA, with some implementations potentially incorporating external charging capabilities via inductive charging from a device outside the body. In some implementations, the inflation and deflation of the segments of the multisegment balloon 942 is not uniform. In some implementations, the sequential balloon pump 940 comprises a peristaltic balloon pump. Elastic appendage with sealing skirt and compliant membrane

[0191] FIG. 10 illustrates an elastic appendage 1040 comprising a sealing skirt 1046 and a compliant membrane 1044 with a structural frame 1042. The structural frame 1042 supports the sealing skirt 1046 and the compliant membrane 1044. The compliant membrane 1044 can be a balloon or a parachute element. The structural frame 1042 provides structural integrity, while the sealing skirt 1046 acts as a barrier, preventing blood from entering the LAA 16. The compliant membrane 1044 is adapted to accommodate and to respond to blood flow, ensuring that the occlusion is effective, and that blood flow is appropriately regulated. In some implementations, the compliant membrane 1044 is configured to bulge both into the LAA 16 and out of the LAA 16. Bulging out of the LAA 16, the compliant membrane 1044 can provide an atrial kick to help flush blood from the LAA 16 and into the ventricle.

[0192] The structural frame 1042 comprises a biocompatible, expandable frame that conforms to the anatomy of the LAA 16, providing structural stability. Attached to the structural frame 1042 is the sealing skirt 1046 that is made of a flexible, biocompatible material. The sealing skirt 1046 is positioned at the distal end of the elastic appendage 1040 to block blood flow into the LAA 16, effectively isolating it. The material of the sealing skirt 1046 can be compliant, ensuring a seal against the inner surface of the LAA 16 to prevent or inhibit blood from entering the LAA 16.

[0193] The interior of the elastic appendage 1040 contains the compliant membrane 1044 that is adapted to accommodate the inflow of blood. As blood enters the elastic appendage 1040, it is directed into the compliant membrane 1044, which expands to allow temporary storage of blood. The elasticity of the compliant membrane 1044 allows the compliant membrane 1044 to return to its original state, pushing blood back out of the elastic appendage 1040. This mechanism ensures that blood does not stagnate within the elastic appendage 1040, thereby reducing the risk of clot formation within the elastic appendage 1040.

[0194] The elastic appendage 1040 is designed for deployment via a transcatheter approach, which can be performed using either transseptal or femoral access. The catheter delivers the elastic appendage 1040 to the desired location in the LAA 16, where the structural frame 1042 is expanded to anchor the elastic appendage 1040 in place. Once deployed, the elastic appendage 1040 conforms to the anatomy of the LAA 16, and the sealing skirt 1046 ensures complete occlusion of blood flow.

[0195] Upon deployment, blood is deflected into the elastic appendage 1040 and subsequently enters the compliant membrane 1044. The elastic properties of this component ensure that blood is expelled from the elastic appendage 1040, preventing pooling and maintaining a healthy circulation dynamic.

[0196] The structural frame 1042 is designed not only for structural support but also to work in concert with the sealing skirt 1046 to ensure an effective seal. The interaction between the structural frame 1042 and the sealing skirt 1046 is engineered to inhibit or prevent leakage around the elastic appendage 1040, enhancing its efficacy in isolating the LAA 16. The expandable nature of the structural frame 1042 enables the structural frame 1042 to adapt to sizes and shapes of the LAA 16, thereby providing a customizable fit.

[0197] The design of the elastic appendage 1040 incorporates features that allow the device to deflect blood flow into the compliant membrane 1044, ensuring efficient blood management within the elastic appendage 1040. The combination of the structural frame 1042 and the sealing skirt 1046 ensures a durable and reliable seal, preventing any blood from re-entering the native appendage after implantation. The ability of the elastic appendage 1040 to accommodate blood flow into the compliant membrane 1044 reduces pressure within the LAA 16, preventing blood stagnation and lowering the risk of thromboembolism. The transcatheter delivery method allows for minimally invasive implantation, reducing patient recovery time and procedural risks. The structural frame 1042 and the sealing skirt 1046 provide a secure and customizable fit, ensuring effective occlusion regardless of anatomical variability.

Anti-clot pocket

[0198] FIGS. 11 A, 11B, 11C, 11D, and HE illustrate an example embodiment of an anti-clot pocket 1140 for implantation in the LAA 16. The anti-clot pocket 1140 includes a plurality of frame members 1144 with a sealing membrane 1142 or cover. In some implementations, the sealing membrane 1142 covers a distal end of the anti-clot pocket 1140 and does not cover a proximal end of the anti-clot pocket 1140 to form the pocket of the anticlot pocket 1140. The plurality of frame members 1144 is configured to change shape during systole and diastole, as illustrated in FIGS. 1 IB-1 IE. The plurality of frame members 1144 is biased in a peanut shape or oval, as illustrated in FIGS. 1 IB and 11C. Thus, during low pressures, the plurality of frame members 1144 maintain the biased shape (or slightly deform relative to the biased shape). During increases in pressure, the plurality of frame members 1144 changes to a more circular shape to enhance atrial compliance, as illustrated in FIGS. HD and HE. [0199] The anti-clot pocket 1140 can include barbs 1146 or other anchors to facilitate implantation in the LAA 16. Responsive to changes in pressure, the anti-clot pocket 1140 changes shape. That is, the anti-clot pocket 1140 opens up (e.g., changing shape from a peanut or oval to a circle) providing compliance and enhancing blood washout.

Deformable LAA implant with a deformable stent and compliant distal diaphragm

[0200] FIGS. 12A, 12B, 12C, 12D, 12E, 12F, 12G, 12H, 121, and 12J illustrate an example of a deformable LAA implant 1240 that is configured to enhance atrial compliance. The deformable LAA implant 1240 features a deformable stent 1246 that can transition between different configurations or shapes to accommodate changes in left atrial pressure and to promote compliance and effective blood washout. The deformable LAA implant 1240, similar to other implants and devices described herein, is adapted to mimic the operation of a healthy heart. That is, the deformable LAA implant 1240 expands and contracts to provide similar functionality to a stretchable or compliant LAA.

[0201] The deformable LAA implant 1240 also includes a distal sealing membrane 1248 coupled to the deformable stent 1246 to aid the deformable stent 1246 in enhancing atrial compliance. The distal sealing membrane 1248 can be configured to bulge into the LAA 16 responsive to elevated or high pressures in the left atrium. The deformable LAA implant 1240 includes a fixation frame 1242 flared radially and configured to secure the deformable LAA implant 1240 against the ostium of the LAA 16 in a sealed manner. The deformable LAA implant 1240 also includes a deformable stent 1246 configured to extend through the LAA 16 and a distal sealing membrane 1248 that is close-ended at the distal end of the deformable LAA implant 1240. In some implementations, the deformable stent can be a covered, oval stent.

[0202] The deformable LAA implant 1240 is designed for deployment in the LAA. This stent transitions between an oval and circular configuration in response to varying left atrial (LA) pressure during the systolic and diastolic phases of the cardiac cycle. This adaptive shape change facilitates blood washout from the appendage while maintaining compliance with the surrounding anatomical structures. The deformable stent 1246 is adapted to expand during atrial systole and to contract during atrial diastole for enhancing compliance of the left atrium, thereby improving heart function.

[0203] The deformable LAA implant 1240 includes the fixation frame 1242, the deformable stent 1246, a tapered portion 1244, and a distal sealing membrane 1248. The fixation frame 1242 and/or the deformable stent 1246 can comprise a Nitinol wire frame. The deformable stent 1246 is adapted to take on a peanut-shaped or oval configuration. The deformable LAA implant 1240 includes a non-porous cover that covers the fixation frame 1242 and the deformable stent 1246. The fixation frame 1242 is at a proximal end of the deformable LAA implant 1240 and is adapted to anchor the deformable LAA implant 1240 within the LAA 16. In some implementations, the deformable LAA implant 1240 also includes barbs to secure it to the LAA ostia. The deformable LAA implant 1240 forms a closed pocket for further sealing the LAA using the distal sealing membrane 1248. The deformable LAA implant 1240 is a compliance enhancing implant that includes an oval stent residing inside the LAA, configured to transition between oval and circular configurations thereof in response to LA pressure changes during systolic and diastolic cycles.

[0204] The deformable LAA implant 1240 includes the deformable stent 1246 configured to extend through the LAA, a proximal attachment portion (e.g., the fixation frame 1242) configured to secure the deformable LAA implant 1240 against the ostium of the LAA 16 (in a sealed manner), and a distal sealing membrane 1248 close-ended at the distal end to seal off the portion of the LAA 16 closer to the pericardial side, so as to prevent clots that may be formed therein from flowing through the deformable stent 1246 into the left atrium. The deformable stent 1246 can be oval-shaped, peanut-shaped, round, and can include spring-like elements, or the like. The fixation frame 1242 is covered by a sleeve which can be made of a clot preventing material, wherein the tapered portion 1244 and the distal sealing membrane 1248 portions can be integral portions of the sleeve covering the deformable LAA implant 1240 itself.

[0205] In some embodiments, the proximal attachment portion can include a fixation frame 1242 covered by a proximal portion of the sleeve, wherein the fixation frame 1242 can be flared radially relative to a central axis of the implant, so as to extend over the LAA ostium 1211. The sleeve surrounding the deformable stent 1246 is adhered to the surrounding LAA wall 1215, such that during normal operation of the oval stent, the LAA wall will move therewith as it transitions between its oval and circular configurations.

[0206] The deformable LAA implant 1240 can also be implemented with a proximal frame portion (e.g., the fixation frame 1242) and a distal frame portion (e.g., the deformable stent 1246). The distal frame portion has a smaller diameter than the proximal frame portion. In such implementations, the distal frame portion is adapted to expand during atrial systole and to contract during atrial diastole to enhance compliance of the left atrium. In some implementations, the proximal frame portion and the distal frame portion are separate frame portions coupled together by the cover. In some implementations, the proximal frame portion and the distal frame portion connect directly to each other. In some implementations, the proximal frame portion and/or the distal frame portion are formed from Nitinol. In some implementations, the proximal frame portion and/or the distal frame portion are made from a braided, self-expanding material.

[0207] In some implementations, the distal frame portion has an oval cross-section in a contracted state. In some implementations, the distal frame portion has a concave surface before deployment in the LAA 16. In some implementations, the distal frame portion has a substantially peanut shaped cross-section before deployment in the LAA 16.

[0208] The proximal frame portion and the distal frame portion can be covered by a cover that extends along the proximal frame portion and the distal frame portion. The cover is adapted to provide a seal at a distal end of the distal frame portion for preventing blood from passing through the deformable LAA implant 1240. In some implementations, the seal is flexible for enhancing compliance of the left atrium during atrial systole. In some implementations, the seal is adapted to move proximally to enhance blood washout from an interior of the deformable LAA implant 1240 during atrial diastole.

|0209| In some embodiments, implantation can be performed as a two-stage procedure, as illustrated in FIGS. 12H, 121, and 12J. A sleeve 1216 is first adhered to the LAA 16 while using an expandable element, such as a balloon 1212, delivered via a delivery catheter 1210, as illustrated in FIG. 12H. After which the deformable LAA implant 1240 is introduced into the sleeve 1216 (at a mid-portion thereof). The method includes expansion of the sleeve 1216 over a balloon 1212 towards the LAA wall and adhering the sleeve 1216 to the LAA 16 by glue injection. The balloon 1212 can remain in its inflated state for a sufficient time during which the glue can cure. Afterward, the balloon 1212 can be deflated and retracted from the sleeve 1216. While the balloon 1212 is shown, it is to be understood that any other type of expanding member (such as a mechanical expanding member) is contemplated. Thereafter, the deformable LAA implant 1240 can be advanced into the sleeve 1216 and deployed there-against, as illustrated in FIG. 121. The deformable LAA implant 1240 can be collapsible for advancement into the left atrial appendage via a catheterization technique. The delivery catheter 1210 can have a length sufficient to advance the deformable LAA implant 1240 through a patient’s vasculature, into the right atrium, and across the atrial septum to the LAA 16.

[0210] In some implementations, the sleeve 1216 and the deformable LAA implant 1240 are not necessarily provided as separate components (e.g., the sleeve 1216 can be disposed around and optionally attached to the deformable LAA implant 1240 to begin with), and implantation can be performed as a one-stage procedure. While glue injection is demonstrated, it is to be understood that adherence can be accomplished by any suitable procedure or mechanism. The deformable stent 1246 can be used to increase compliance as it transitions between its oval configuration and the more circular configuration in response to the varying pressure during systolic and diastolic phases.

[0211] The sleeve 1216 and the deformable stent 1246 can be designed to have an outer diameter of about 30 mm, with the sleeve 1216 having a length of about 25 mm and the deformable stent 1246 having a length of about 15 mm (these dimensions are mentioned by way of example only). The change in cross-sectional area during transition between the oval and circular configuration can be in the range of 2 cm² to 3 cm² to facilitate change in pressure in a range of about 10 mmHg to about 40 mmHg. Blood contained in the distal portion of the LAA 16, between the deformable LAA implant 1240 (e.g., the distal sealing membrane 1248) and the pericardial side of the LAA 16, as illustrated in FIG. 12J, may form a hardened thrombotic region that may impact compliance. To maintain desirable tissue compliance and to prevent such hardening, a method of implantation can optionally include a preliminary step of draining blood from the portion of the LAA 16 enclosed between the deformable LAA implant 1240 and the pericardial side of the LAA 16 by appropriate suction means. In some implementations, the deformable LAA implant 1240 can further include a pressure sensor, which can be optionally mounted on the distal or proximal portions of the sleeve 1216.

[0212] The deformable stent 1246 is adapted to transition between an oval configuration (or a peanut-shaped configuration) and a more circular configuration in response to pressure changes in the left atrium during the systolic and diastolic phases of the cardiac cycle. This transition provides compliance with the anatomical structure and promotes blood washout, reducing the risk of thrombus formation. The shape change occurs as a pocket within the deformable stent 1246 opens up from a peanut-shaped configuration to a circular shape, increasing its internal volume and compliance. This compliance feature ensures that the deformable LAA implant 1240 adapts to blood flow dynamics, reducing pressure build-up and promoting efficient circulation within the LAA.

[0213] The deformable LAA implant 1240 can be encased in a cover (e.g., a non- porous cover) that prevents blood from permeating the structure and ensures complete occlusion of the LAA 16. The cover can be made of any suitable material, such as Dacron. The deformable stent 1246 can be constructed with a nitinol wire frame, which is either peanut-shaped or oval. The nitinol allows for flexibility and shape-memory properties, enabling the deformable stent 1246 to adapt to changing pressures. The proximal section of the deformable LAA implant 1240 features the fixation frame 1242 that transitions into the deformable stent 1246 upon deployment, anchoring the deformable LAA implant 1240 to the LAA ostia. Barbs can be located along the fixation frame 1242 to securely anchor the deformable LAA implant 1240 within the LAA ostia, preventing migration and ensuring stability. A closed pocket feature ensures occlusion of the LAA 16, preventing blood from pooling or clotting within the LAA 16. The deformable LAA implant 1240 includes a sealing mechanism and the distal sealing membrane 1248 that together provide a robust seal to prevent blood from re-entering the LAA 16. In some implementations, the distal sealing membrane 1248 can bulge distally once implanted, responsive to elevated atrial pressure (e.g., during atrial systole), as illustrated in FIG. 12H. Responsive to reduced atrial pressure (e.g., during atrial diastole), the distal sealing membrane 1248 can move proximally, aiding in expelling blood from the LAA 16. This movement of the distal sealing membrane 1248 helps to enhance compliance of the left atrium, thereby improving heart function. In some implementations, the distal sealing membrane 1248 is adapted to remain relatively stationary, so that it does not significantly bulge proximally or distally.

[0214] The device is configured to mitigate clot formation by promoting blood flow around the structure and preventing stagnation. This pocket can also act as an area of compliance to further adapt to blood flow dynamics within the LAA. The device includes a left atrial appendage sleeve, which is segmented into three distinct zones. The proximal zone is configured for fixation to the ostium and to provide sealing at the point of attachment. The middle zone incorporates the compliance feature of the device, which can take on an oval or peanut shape, or other spring-like configurations. If necessary, this zone can also contribute to the sealing function. The distal zone facilitates the transition area and contains the closed pocket to fully isolate the LAA from blood flow. The LAA sleeve is made from materials that are resistant to clot formation, enhancing its efficacy in preventing thrombus development within the appendage.

Deformable LAA implant with a deformable stent

[0215] FIGS. 13A, 13B, 13C, 13D, 13E, and 13F illustrate an example of a deformable LAA implant 1340 with a deformable stent 1346. The deformable LAA implant 1340 is similar to the deformable LAA implant 1240 of FIGS. 12A-12J, except that the deformable LAA implant 1340 includes a longer proximal portion to improve sealing an anchoring to the LAA 16 and the deformable LAA implant 1340 does not include a distal sealing membrane.

[0216] The deformable LAA implant 1340 is a passive deformable stent structure covered by a non-permeable elastic membrane. The deformable LAA implant 1340 is delivered into the LAA 16 from a series of nested access and delivery catheters, whereby it self-expands and anchors and seals to the ostium of the LAA. When in place, the deformable LAA implant 1340 has a circular section that seals and anchors to the ostium of the LAA 16 and the distal section of the deformable LAA implant 1340 has as its cross-section a collapsed geometry (e.g., a peanut) that is adapted to expand under rising pressures in the left atrium. As a result, the deformable LAA implant 1340 is adapted to reduce the effective peak left atrial pressure. When the left atrial pressures lower, the deformable LAA implant 1340 contracts back to the peanut-shape and blood is extracted back out of the implant pocket into the left atrium, thereby inhibiting or preventing blood stasis in the deformable LAA implant 1340. This repeats each cardiac cycle with the cumulative effect being the overall lowering of left atrial pressures over time and consequently reducing symptoms of heart failure.

102171 FIG. 13A illustrates the deformable LAA implant 1340 with a cover, the deformable LAA implant 1340 including a fixation frame 1342 with a tapered portion 1344 transitioning to the deformable stent 1346 that is adapted to change shape between a flattened oval or a peanut shape to a rounder oval or more circular shape. The cover can be a non- permeable, elastic membrane similar to other embodiments described herein. FIGS. 13B and 13C illustrate a top view and a side view of the deformable LAA implant 1340 that is uncovered to show the underlying structure that includes a braided, self-expanding wire frame. In some implementations, the deformable stent 1346 can be shrouded inside a cylindrical section to protect the dynamic, deforming portion of the deformable LAA implant 1340 from the walls of the LAA tissue.

[0218] The deformable LAA implant 1340 includes the tapered portion 1344 between the deformable stent 1346 and the fixation frame 1342, the fixation frame 1342 being flanged radially outwards. The flanged portion of the fixation frame 1342 is configured to be relatively rigid to anchor and seal against the LAA 16. This is in contrast to the deformable stent 1346 that is configured to move between an oval or peanut-shape and an expanded shape (e.g., a more circular shape). The deformable stent 1346 is configured to have a smaller radius than the fixation frame 1342. The tapered portion 1344 is configured to taper from the fixation frame 1342 to the deformable stent 1346 and is configured to be sufficiently flexible to inhibit or prevent motion transmission between the deformable stent 1346 and the fixation frame 1342. The different behavior of the different portions of a braid can be achieved by changing the rigidities of the portions corresponding to the fixation frame 1342 and the deformable stent 1346. This may be accomplished by changing the weave density and implementing appropriate weaving patterns between the filaments of the braid.

[0219] The deformable LAA implant 1340 forms a central lumen which mechanically attaches to a delivery catheter 1310, as illustrated in FIG. 13D. The central lumen also acts as a way in which to evacuate the blood from the distal section of the LAA 16 after deployment of the deformable LAA implant 1340 (e.g., through the lumen in the internal catheter using suction at the operator’s end). The delivery catheter 1310 includes an external, larger catheter and a nested, smaller internal catheter. The internal catheter is adapted to translate within the external catheter and the deformable LAA implant 1340 is configured to connect to the internal catheter via a threaded feature (e.g., male/female threads on the end of the internal catheter tip and the deformable LAA implant 1340, respectively) or via other mechanical connections that can be removed upon deployment of the deformable LAA implant 1340. The deformable LAA implant 1340, while connected to the end of the internal catheter, is adapted to collapse down into the lumen of the external, larger catheter. Upon deployment, the internal catheter is adapted to translate distal to the actuation device (being operated by the physician) whereupon the deformable LAA implant 1340 is configured to exit the distal end of the external catheter and to self-expand into place at the ostium of the LAA 16, as shown in FIG. 13E. The internal catheter then disconnects from the deformable LAA implant 1340 and is removed. The internal catheter is configured to have a patent lumen running the length of the catheter. The lumen of the internal catheter is adapted to be a conduit for blood to be evacuated from the opposite side of the deformable LAA implant 1340 in the cavity of the LAA 16. In some implementations, there is a one-way valve (e.g., a duckbill valve) to allow blood to be evacuated only in the direction leaving the LAA 16.

[0220] The deformable LAA implant 1340 is adapted to mimic the functionality of a healthy heart. For example, the distal frame portion of the deformable LAA implant 1340 expands during atrial systole, as illustrated in FIG. 13E, and to contract during atrial diastole, as illustrated in FIG. 13F. This expansion and contraction of the distal frame portion enhances compliance of the left atrium, thereby improving heart function.

[0221] Similar to the deformable LAA implant 1240, the deformable LAA implant 1340 can also be implemented with a proximal frame portion (e.g., the fixation frame 1342) and a distal frame portion (e.g., the deformable stent 1346) where the distal frame portion has a smaller diameter than the proximal frame portion. The distal frame portion is adapted to expand during atrial systole and to contract during atrial diastole to enhance compliance of the left atrium. The proximal frame portion and the distal frame portion can be covered by a cover that extends along the proximal frame portion and the distal frame portion. The cover is adapted to provide a seal at a distal end of the distal frame portion for preventing blood from passing through the deformable LAA implant 1340.

[0222] FIGS. 14A, 14B, and 14C illustrate another example of a deformable LAA implant 1440 in which a fixation frame 1442 (e.g., a proximal frame portion) and a deformable stent 1446 (e.g., a distal frame portion) are formed as separate components that are then coupled to each other. The deformable LAA implant 1440 is similar to the deformable LAA implant 1240 and the deformable LAA implant 1340 described herein. The deformable LAA implant 1440 also includes a tapered portion 1444 between the fixation frame 1442 and the deformable stent 1446. To couple the fixation frame 1442 to the deformable stent 1446, appropriate couplers, such as loops 1445 or other types of flexible connectors, are used. The deformable stent 1446 can be formed from a laser-cut Nitinol, which has been previously shown to properly move between the compressed and expanded states. The fixation frame 1442 can be formed of a braid.

[0223] It is to be understood that although certain figures do not show a cover, the deformable LAA implants described herein are configured to include a cover over the deformable stent and the distal end portion.

[0224] FIGS. 15A, 15B, 15C, 15D, 15E, 15F, 15G, and 15H illustrate another deformable LAA implant 1540 that is adapted to have a significantly longer region of sealing compared to the deformable LAA implant 1240, deformable LAA implant 1340, and the deformable LAA implant 1440. With these deformable LAA implants, a challenge relates to the short sealing portion (e.g., the fixation frame and the tapered portion), making it difficult to achieve adequate sealing within the LAA. Thus, the deformable LAA implant 1540 includes a longer region of sealing, e.g., a sealing portion 1544. The deformable LAA implant 1540 does not include a flanged fixation frame as with the other deformable LAA implants described herein. This is because the axis of the LAA (and the implant extending therein) is not completely perpendicular to the ostium which means that fixation of the deformable LAA implant 1540 can rely on anchors instead of a flanged fixation frame to provide adequate anchoring.

[0225] The deformable LAA implant 1540 includes an elongated cylindrical outer sealing portion, the sealing portion 1544, that is configured to expand against the walls of the LAA 16 and seal thereagainst. The deformable LAA implant 1540 includes a deformable stent 1546 that is situated within a lumen formed by the sealing portion 1544. The deformable stent 1546 is connected to the sealing portion 1544 by a transition portion 1542 extending between a proximal edge of the sealing portion 1544 and a proximal edge of the deformable stent 1546. The deformable LAA implant 1540 is covered by a membrane, such that while the deformable stent 1546 can pump blood volume contained within, the sealing portion 1544 disposed over the deformable stent 1546 serves to seal against the LAA. This configuration advantageously provides a significantly longer and larger area of sealing. In some implementations, the deformable LAA implant 1540 is adapted to be delivered to the LAA in a compacted configuration by which the sealing portion 1544 is compressed over the deformable stent 1546.

[0226] FIGS. 15D-15F illustrate another delivery configuration in which the deformable stent 1546 is proximal to the sealing portion 1544 during delivery. This can advantageously result in a smaller crimped profile. Upon reaching the LAA, the sealing portion 1544 can be expanded against the LAA walls, as illustrated in FIG. 15G. Then, the delivery catheter 1510 can be used to push the deformable stent 1546 into the sealing portion 1544 (which maintains its position due to being anchored against the LAA at this stage), as illustrated in FIG. 15H.

End-deformable stent

[0227] FIGS. 16A, 16B, 16C, 16D, 16E, and 16F illustrate an example of an end- deformable stent 1640 that is configured to be implanted in the LAA to enhance atrial compliance. The end-deformable stent 1640 includes a distal portion that is adapted to pulsate between a concave and a convex configuration. The end-deformable stent 1640 includes a frame 1642 extending between a proximal end and a distal end along a length adapted to provide desirable sealing against the wall of the LAA. The end-deformable stent 1640 also includes a movable distal end portion 1646 comprised of a plurality of struts which are archshaped and extend both radially inwards and to some extent in an axial direction. A cover 1644 is disposed around the frame 1642 to seal against the LAA wall, and over the distal arcuate radial struts of the movable distal end portion 1646 to serve as a distal diaphragm that is closed at the distal end of the end-deformable stent 1640.

[0228] In some implementations, the body of the end-deformable stent 1640 can be roughly barrel-shaped to improve sealing engagement with the surrounding LAA anatomy. The distal arcuate radial struts of the movable distal end portion 1646 are configured to move between convex and concave configurations in response to increases and decreases in blood pressure. For example, FIG. 16E illustrates the end-deformable stent 1640 in the convex configuration and FIG. 16F illustrates the end-deformable stent 1640 in the concave configuration. This change in configurations changes the volume of the end-deformable stent 1640 to enhance atrial compliance.

[0229] In some implementations, blood can be drained from the LAA portion enclosed between the end-deformable stent 1640 and the distal end of the LAA by an appropriate suction means. For example, a guide catheter can be advanced and terminate at a distal portion of the LAA 16. The end-deformable stent 1640 can be deployed inside the LAA 16, and after suctioning the blood, the guide catheter can be retracted. In some implementations, the catheter can suction the blood through the center of the end-deformable stent 1640. This can be achieved by various means that allow a suction catheter to extend through a central opening formed at the distal end of the end-deformable stent 1640 (such as the central ring 1645 that can be seen in FIG. 16C). The suction catheter is configured to be released from the end-deformable stent 1640 and retrieved, such that the opening at the central ring 1645 can be closed after releasing the suction catheter to seal the distal end. For example, a suction catheter can be threadedly coupled at the central ring 1645, and a flap can be configured to closed over the distal opening as soon as the catheter is released and removed. In some implementations, the catheter can extend through a one-way valve configured to prevent backflow in a proximal direction after removal thereof.

Appendage wedge

[0230] FIGS. 17A and 17B illustrate an appendage wedge 1740 configured to be implanted in the LAA 16. The appendage wedge 1740 includes a proximal opening defined by a cover 1742 that is shaped by a wire spring 1744 that presses outward on the cover 1742. The appendage wedge 1740 also includes an anchor barb 1746 configured to secure the appendage wedge 1740 to the LAA. During diastole, the opening is pressed into a flat, narrow opening due to the decreased pressure on the cover 1742 that allows the wire spring 1744 to press outward on the cover 1742. During systole, the opening opens wider due to the increase in pressure pressing the wire spring 1744 inward, thereby changing the shape of the opening to be wider.

[0231] The wire spring 1744 presses outward along two edges which causes the appendage wedge 1740 to flatten at diastolic pressures. The anchor barb 1746 at the apex of the wedge may be used to anchor the appendage wedge 1740 to the tissue. As pressure in the LA increases, the wedge inflates thus increasing its internal volume. Energy is stored in the spring wire as the pressure increases from diastole to systole. This energy is returned as the pressure decreases from systole to diastole. The volumetric change of the appendage wedge 1740 increases atrial compliance during the cardiac cycle. Blood flow washing in and out each cardiac cycle reduces or minimizes thrombus formation.

[0232] The appendage wedge 1740 can be crimped and delivered to the LA A 16 using a delivery catheter 1710. The delivery catheter 1710 can be configured to have a length sufficient to advance the appendage wedge 1740 through a patient’s vasculature, into a right atrium, and across an atrial septum to the LAA 16.

C-Shaped Clip

[0233] FIG. 18 illustrates an internal compliance assist device 1840 that is configured to store energy during peak left atrial pressure and to squeeze during low pressure. The device 1840 includes a C-shaped clip implanted in the LAA 16. During high pressure, the C- shaped clip of the device 1840 is compressed to open the ostium of the LAA 16. During low pressure, the C-shaped clip of the device 1840 presses outward on the LAA 16 to flatten the opening of the LAA 16.

Magnetic squeeze

[0234] FIGS. 19A, 19B, 19C, 19D, and 19E illustrate a magnetic device 1940 configured to enhance compliance of the left atrium by pressing the walls of the LAA 16. The magnetic device 1940 includes a pair of magnets 1942 attached to the walls of the LAA 16, with the magnets 1942 oriented in polarity such that the magnets are drawn toward each other. Note that magnets oriented in polarity so as to repel each other may also be considered, depending on the implant configuration. The magnets 1942 may comprise soft/flexible magnetic sheets (not shown), which may he secured to opposing sides of an LAA implant device.

[0235] FIGS. 19A-19C illustrate implantation of the magnetic device 1940. In FIG. 19A, access to the LAA 16 is achieved using a transseptal approach with a delivery catheter 1910 where a balloon 1912 with the pair of magnets 1942 are deployed. In FIG. 19B, the balloon 1912 is inflated using the delivery catheter 1910 to attach the pair of magnets 1942 on the upper and lower surfaces of the LAA 16. In FIG. 19C, the balloon 1912 is deflated and the delivery catheter 1910 is retrieved.

[0236] FIG. 19D illustrates the magnetic device 1940 during atrial diastole where the pressure presses apart the pair of magnets 1942. FIG. 19E illustrates the magnetic device 1940 during atrial systole where the drop in pressure allows the pair of magnets 1942 to approximate to one another. This interaction with systole and diastole pushes and pulls the walls of the LAA 16 to facilitate blood washout and to enhance atrial compliance. That is, increased pressure separates the pair of magnets 1942 allowing the LAA 16 to fill with blood. During atrial systole, pressure reduces and the pair of magnets 1942 close again and aid in ejection of blood from the LAA 16. In some implementations, a stent is also placed in the LAA to enhance support for the pair of magnets 1942.

External spring

[0237] FIGS. 20A, 20B, and 20C illustrate another example device 2040 configured to enhance atrial compliance. The device 2040 includes a first stent 2042 configured to be implanted in a pulmonary vein and a second stent 2044 to be implanted in the left atrium. A spring 2046 attaches the first stent 2042 and the second stent 2044. The spring 2046 is adapted to elongate and contract in accordance with the pressures during the cardiac cycle to enhance filling and ejection of blood in the LA, as shown in FIGS. 20A and 20B.

[0238] In some implementations, the device 2040 is configured to be implanted with the first stent 2042 in the LAA 16. In such implementations, the spring 2046 can couple the first stent 2042 to an anchor or other element 2045 that is attached to the opposite left atrial wall from the LAA 16. Similarly, the spring 2046 is adapted to elongate and contract in accordance with the pressures during the cardiac cycle to enhance with filling and ejection of blood in the left atrium. In certain implementations, the first stent 2042 is an occluder.

Membrane with in-plane deflection

[0239] FIGS. 21A, 21B, 21C, and 21D illustrate a device 2140 configured to provide in-plane deflection with a membrane 2142. The membrane 2142 is flexible at its perimeter around the ostium, so it can deflect in-plane with the LAA ostium during the cardiac cycle (and not immobilize the tissue surrounding the ostium). The membrane 2142 thus deflects outwards/in-plane with the LAA ostium.

[0240] The membrane 2142 is similar to a drum head or elastic sheet with nothing behind it. The membrane 2142 is thus configured similar to an atrial wall that is stretchy in 2 dimensions (e.g., along the surface area rather than perpendicular to it). The membrane 2142 can be tied to the ostium. In some implementations, the membrane 2142 acts as an occluder. In some implementations, the membrane 2142 does not deflect in and out of the LAA, rather it allows the ostium to open. This is in contrast to typical occluder devices. LAA closure with flushing mechanism

[0241] FIGS. 22 A and 22B illustrate an example embodiment of an LA A closure device 2240 with a flushing mechanism. The LAA closure device 2240 is configured to reduce the risk of clot formation not by occluding the appendage but by increasing the flow from and out of it. Because the appendage is not being occluded, the LAA still acts as an extra blood volume for the left atrium during systole and diastole, thereby increasing the compliance of the heart.

[0242] The LAA closure device 2240 is implanted in a similar way to a typical LAA occlusion procedure, minimally invasive transcatheter procedure. The LAA closure device 2240 includes an expandable cylindrical frame 2242 on its circumference. The circumference is covered with sealed cloth 2244. On the proximal edge there is an opening to an inner volume reservoir. On the distal edge there is a second sealed cloth 2246 (as in a typical LAA occluder). The inner volume of the device can change, it does that using sails 2248 that act like a duck bill valve. During systole, the sails 2248 come closer to each other, thereby flushing blood from the inner volume. During diastole, the sails 2248 move away from each other, thereby filling the inner volume with blood. The LAA closure device 2240 moves the occlusion plane deeper into the LAA, which is usually narrower and more difficult to flush. The sails 2248 are fixated at the distal and proximal planes of the LAA closure device 2240. The material in between is configured to move and to change shape.

[0243] In some implementations, the LAA closure device 2240 is cylindrical, cloth- sealed, with a self-expandable frame. The LAA closure device 2240 includes a proximal surface, a distal surface, with sails 2248 in between. The sealed cloth 2244 provides an occlusion area. During diastole, the sails 2248 open and during systole, the sails 2248 close.

[0244] FIGS. 23 A, 23B, 23C, 23D, 23E, and 23F illustrate another example embodiment of an LAA closure device 2340 with a flushing mechanism. Like the embodiment with the sails in FIGS. 22A and 22B, the LAA closure device 2340 comprises a self-expandable cylindrical frame 2342 on its circumference. The circumference is covered with sealed cloth 2343. On the proximal edge there is an opening to an inner volume reservoir. Inside the inner volume of the LAA closure device 2340 there is a set of flexible membranes 2346 which can change their geometry during heart cycles due to pressure changes. The membranes 2346 concave during systole and convex during diastole, as illustrated in FIGS. 23B and 23C. The change in geometry of the membranes 2346 change in geometry improves the blood flow inside the LAA closure device 2340. The membranes 2346 can be coupled to a support rod 2344 extending from the proximal edge of the cylindrical frame 2342.

[0245] The LAA closure device 2340 is configured to keep the extra blood volume of the LAA and to provide a flushing mechanism for the blood to prevent thrombi formation. The LAA closure device 2340 moves the occlusion plane deeper into the LAA, which is usually narrower and more difficult to flush. The LAA closure device 2340 includes a cylindrical, cloth sealed, self-expandable frame with a plurality of flexible membranes within. FIGS. 23E and 23F illustrate example membranes 2346. The membrane 2346 can be Nitinol shape set wire, encapsulated with ePTFE, an ePTFE membrane, and/or ePTFE encapsulated Nitinol braid.

Additional Features and Embodiments

[0246] The present disclosure provides methods and devices (including various medical implants) for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. The term “implant” is used herein according to its plain and/ordinary meaning and may refer to any medical implant, frame, valve, shunt, stent, anchor, and/or similar devices for use in treating various conditions in a human body. Implants may be delivered via catheter (i.e., transcatheter) for various medical procedures and may have a generally sturdy and/or flexible structure. The term “catheter” is used herein according to its broad and/ordinary meaning and may include any tube, sheath, steerable sheath, steerable catheters, and/or any other type of elongate tubular delivery device comprising an inner lumen configured to slidably receive instrumentation, such as for positioning within an atrium or appendage, including for example delivery catheters and/or cannulas. Some transcatheter processes described herein can utilize a single catheter or multiple catheters.

[0247] Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0248] The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0249] The above description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed above. While specific embodiments, and examples, are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while processes or blocks are presented in a given order, alternative embodiments may perform routines having steps, or employ systems having blocks, in a different order, and some processes or blocks may be deleted, moved, added, subdivided, combined, and/or modified. Each of these processes or blocks may be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks may instead be performed in parallel or may be performed at different times.

[0250] Certain terms of location are used herein with respect to the various disclosed embodiments. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe a spatial relationship of one device/element or anatomical structure relative to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. Spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.

[0251] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment.

[0252] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited. In some contexts, description of an operation or event as occurring or being performed “based on,” or “based at least in part on,” a stated event or condition can be interpreted as being triggered by or performed in response to the stated event or condition.

[0253] With respect to the various methods and processes disclosed herein, although certain orders of operations or steps are illustrated and/or described, it should be understood that the various steps and operations shown and described may be performed in any suitable or desirable temporal order. Furthermore, any of the illustrated and/or described operations or steps may be omitted from any given method or process, and the illustrated/described methods and processes may include additional operations or steps not explicitly illustrated or described.

[0254] It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above but should be determined only by a fair reading of the claims that follow.

[0255] Unless the context clearly requires otherwise, throughout the description and the claims, the terms “comprise,” “comprising,” “have,” “having,” “include,” “including,” and the like are to be construed in an open and inclusive sense, as opposed to a closed, exclusive, or exhaustive sense; that is to say, in the sense of “including, but not limited to.”

[0256] The word “coupled”, as generally used herein, refers to two or more elements that may be physically, mechanically, and/or electrically connected or otherwise associated, whether directly or indirectly (e.g., via one or more intermediate elements, components, and/or devices. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole, including any disclosure incorporated by reference, and not to any particular portions of the present disclosure. Where the context permits, words in present disclosure using the singular or plural number may also include the plural or singular number, respectively.

[0257] The word “or” in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, as used herein, the term “and/or” used between elements (e.g., between the last two of a list of elements) means any one or more of the referenced/related elements. For example, the phrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C,” or “A, B, and C.”

[0258] As may be used herein, the terms “substantially” and “approximately” provides an industry- accepted tolerance for its corresponding term and/or relativity between items. For some industries, an industry-accepted tolerance is less than one percent, while for other industries, the industry-accepted tolerance may be 10 percent or more. Other examples of industry-accepted tolerances range from less than one percent to fifty percent. Industry- accepted tolerances correspond to, but are not limited to, component values, integrated circuit

-M- process variations, temperature variations, rise and fall times, thermal noise, dimensions, signaling errors, dropped packets, temperatures, pressures, material compositions, and/or performance metrics. Within an industry, tolerance variances of accepted tolerances may be more or less than a percentage level (e.g., dimension tolerance of less than approximately +/- 1%). Some relativity between items may range from a difference of less than a percentage level to a few percent. Other relativity between items may range from a difference of a few percent to magnitude of differences.

[0259] One or more embodiments have been described above with the aid of method steps illustrating the performance of specified functions and relationships thereof. The boundaries and sequence of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternate boundaries and sequences can be defined so long as the specified functions and relationships are appropriately performed. Any such alternate boundaries or sequences are thus within the scope and spirit of the claims. Further, the boundaries of these functional building blocks have been arbitrarily defined for convenience of description. Alternate boundaries could be defined as long as the certain significant functions are appropriately performed. Similarly, flow diagram blocks may also have been arbitrarily defined herein to illustrate certain significant functionality.

[0260] To the extent used, the flow diagram block boundaries and sequence could have been defined otherwise and still perform the certain significant functionality. Such alternate definitions of both functional building blocks and flow diagram blocks and sequences are thus within the scope and spirit of the claims. One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.

[0261] The one or more embodiments are used herein to illustrate one or more aspects, one or more features, one or more concepts, and/or one or more examples. A physical embodiment of an apparatus, an article of manufacture, a machine, and/or of a process may include one or more of the aspects, features, concepts, examples, etc. described with reference to one or more of the embodiments discussed herein. Further, from figure to figure, the embodiments may incorporate the same or similarly named functions, steps, modules, etc. that may use the same, related, or unrelated reference numbers. The relevant features, elements, functions, operations, modules, etc. may be the same or similar functions or may be unrelated.

Claims

WHAT IS CLAIMED IS:

1. An implant adapted for deployment in a left atrial appendage, the implant comprising: a proximal frame portion; a distal frame portion; and a cover extending along the proximal frame portion and the distal frame portion, the cover providing a seal at a distal end of the distal frame portion for preventing blood from passing through the implant, wherein the distal frame portion has a smaller diameter than the proximal frame portion, wherein the distal frame portion is adapted to expand during atrial systole and to contract during atrial diastole for enhancing compliance of a left atrium, thereby improving heart function.

2. The implant of claim 1, wherein the proximal frame portion is sized to anchor the implant at an ostium of the left atrial appendage.

3. The implant of claim 1, wherein the distal frame portion has an oval crosssection in a contracted state.

4. The implant of claim 3, wherein the distal frame portion has a concave surface before deployment in the left atrial appendage.

5. The implant of claim 4, wherein the distal frame portion has a substantially peanut shaped cross-section before deployment in the left atrial appendage.

6. The implant of claim 1, wherein the seal is flexible for enhancing compliance of the left atrium during atrial systole.

7. The implant of claim 6, wherein the seal is adapted to move proximally to enhance blood washout from an interior of the implant during atrial diastole.

8. The implant of claim 1, wherein the cover couples the proximal frame portion to the distal frame portion.

9. The implant of claim 1, wherein the proximal frame portion and the distal frame portion are formed from Nitinol.

10. The implant of claim 1, wherein the proximal frame portion and the distal frame portion are made from a braided, self-expanding material.

11. The implant of claim 1 , wherein the proximal frame portion and the distal frame portion are made from different materials.

12. The implant of claim 11, wherein the proximal frame portion radially expands to a substantially circular cross-section during diastole.

13. The implant of claim 1, wherein the cover is made from Dacron.

14. The implant of claim 1 , wherein the implant is collapsible for advancement into the left atrial appendage via a catheterization technique.

15. The implant of claim 14, wherein a catheter is provided for delivering the implant, the catheter having a length sufficient to advance the implant through a patient’s vasculature, into a right atrium, and across an atrial septum to the left atrial appendage.

16. An end-deformable stent adapted to be implanted in a left atrial appendage (LAA) of a patient to enhance atrial compliance, the end-deformable stent comprising: a frame extending between a proximal end and a distal end; and a movable distal end portion comprising a plurality of struts that are arch-shaped and that extend radially inwards as well as in an axial direction, wherein the movable distal end portion is configured to pulsate between a convex configuration and a concave configuration responsive to changes in left atrial pressure.

17. The end-deformable stent of claim 16 further comprising a cover that is disposed around the frame and the movable distal end portion.

18. The end-deformable stent of claim 17, wherein the cover acts as a distal diaphragm as the movable distal end portion pulsates between the convex configuration and the concave configuration.

19. The end-deformable stent of claim 16, wherein the frame is barrel-shaped to enhance sealing with the LAA.

20. The end-deformable stent of claim 16, wherein the plurality of struts of the movable distal end portion are coupled to a central ring.

21. The end-deformable stent of claim 20, wherein a delivery catheter is adapted to couple to the central ring to enable suction of blood from the LAA upon delivery and implantation of the end-deformable stent.

22. The end-deformable stent of claim 21, wherein the central ring is configured to close after removal of the delivery catheter.

23. The end-deformable stent of claim 22, wherein the central ring includes a flap that is configured to close the central ring after removal of the delivery catheter.

24. The end-deformable stent of claim 21, wherein the delivery catheter extends through a one-way valve at the central ring.

25. A left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant comprising: a compliant membrane; and an annular frame portion coupled to the compliant membrane, the annular frame portion configured to be anchored at an ostium of a LAA of a patient, wherein the compliant membrane is configured to provide a pressure-mediated radial expansion of the compliant membrane during atrial filling, wherein the compliant membrane is configured to assist in ejection of blood from the LAA to a left atrium during left atrium systole.

26. The LAA implant of claim 25, wherein the compliant membrane is configured to bulge inward into the LAA responsive to high left atrial pressures.

27. The LAA implant of claim 26, wherein the compliant membrane is configured to return to the ostium after bulging inward into the LAA responsive to low left atrial pressures to assist in the ejection of blood from the LAA.

28. The LAA implant of claim 25, wherein the compliant membrane is configured to occlude the LAA.

29. The LAA implant of claim 25, wherein the annular frame portion includes anchoring features to anchor securely to the ostium of the LAA.

30. The LAA implant of claim 25 further comprising a distal frame portion extending distally into the LAA, the distal frame portion coupled to the annular frame portion to form a cavity into which the compliant membrane is configured to extend.