Implant for improving atrial compliance

Abstract

Disclosed herein are devices and methods for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. The disclosed technology reduces the temporary increase in blood flow and pressure from the venous system into the heart (which drains from the body). In the case of exertion, blood can shift from the "non-stressed" reservoirs of the vasculature to the "stressed" reservoirs. By inhibiting this sharp shift of blood from the non-stressed reservoirs to the stressed reservoirs, the undesirable surge of blood volume into the already overburdened left heart can be avoided. Certain embodiments provide ways to maintain or increase atrial elasticity or atrial compliance using devices implanted in the left atrium and / or the 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

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 565,917, filed March 17, 2024, the entire disclosure of which is incorporated herein by reference in its entirety. Background of the Invention Technical Field

[0003] This disclosure relates to apparatus and methods for addressing elevated left-side filling pressure in the heart. Background Technology

[0004] The heart is a pump consisting of four chambers. The heart is divided in the middle into right and left sides, and each side is further divided into two chambers—the upper chamber called the atrium and the lower chamber called the ventricle. The atria receive blood entering the heart, and the ventricles pump the blood out of the heart. The cardiac cycle is the process by which the heart repeatedly contracts and relaxes to pump blood throughout the body. When the two atria contract, the cardiac cycle begins, pushing blood into the ventricles. Then, the ventricles contract, forcing blood out of the heart. Diastole is the portion of the cardiac cycle during which the heart muscle relaxes and the chambers of the heart fill with blood. Contraction is the portion of the cardiac cycle during which the heart muscle contracts, pushing blood out of the heart and into the large blood vessels of the circulatory system.

[0005] Diastolic dysfunction refers to problems with diastole. Specifically, diastolic dysfunction occurs when the lower chambers of the heart fail to relax as they normally would. As a result, the ventricles cannot fill with blood as normally would, and the subject may experience increased cardiac pressure. This can lead to fluid buildup in the lungs, abdomen, and legs, and may develop into diastolic heart failure. Summary of the Invention

[0006] This article describes methods and / or devices that provide various ways to inhibit or prevent elevated pressure from propagating posteriorly from the left heart to the pulmonary vascular system. These methods and / or devices are configured to reduce blood flow into the heart and lungs.

[0007] This article describes methods and / or devices that provide various ways to inhibit or prevent the propagation of elevated pressure from the left heart to the pulmonary vascular system. These methods and / or devices are configured to enhance atrial compliance to address temporary increases in left atrial pressure. These methods and / or devices may include one or more components implanted in the left atrial appendage.

[0008] In some aspects, the technology described herein relates to an implant suitable for deployment in the left atrial appendage. The implant includes a proximal frame portion; a distal frame portion; and a cap extending along the proximal and distal frame portions, the cap providing a seal at the distal end of the distal frame portion to prevent 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 contract during atrial diastole to enhance left atrial compliance, thereby improving cardiac function.

[0009] In some implementations, the proximal frame portion is sized to anchor the implant at the opening of the left atrial appendage.

[0010] In some embodiments, the distal frame portion has an elliptical cross-section in the contracted state. In some embodiments, the distal frame portion has a concave surface before being deployed into the left atrial appendage. In some embodiments, the distal frame portion has a substantially peanut-shaped cross-section before being deployed into the left atrial appendage.

[0011] In some embodiments, the seal is flexible to enhance left atrial compliance during atrial contraction. In some embodiments, the seal is adapted to move proximally to enhance blood flushing within the implant during atrial diastole.

[0012] In some embodiments, the cover connects the proximal frame portion to the distal frame portion. In some embodiments, the proximal and distal frame portions are formed of nitinol. In some embodiments, the proximal and distal frame portions are made of a woven, self-expanding material.

[0013] In some embodiments, the proximal and distal support portions are made of different materials. In some embodiments, the proximal frame portion expands radially into a substantially circular cross-section during diastole.

[0014] In some implementations, the cover is made of polyester.

[0015] In some embodiments, the implant is foldable to be advanced into the left atrial appendage via catheter insertion techniques. In some embodiments, a catheter for delivering the implant is provided, having a length sufficient to advance the implant through the patient's vascular system, into the right atrium, and across the interatrial septum to reach the left atrial appendage.

[0016] In some aspects, the technology described herein relates to an elastic appendage configured for implantation in a patient's left atrial appendage, the elastic appendage comprising: a frame forming a ring at a proximal end; a first membrane coupled to the ring formed by the frame; and a second membrane coupled to the frame, wherein the frame is configured to fill a space in the patient's left atrial appendage, wherein, in a deployment configuration, the first membrane is configured to be substantially flush with the ring formed by the frame in response to low left atrial pressure, and wherein, in a deployment configuration, the first membrane is configured to deflect into a cavity formed by the frame and the second membrane in response to high left atrial pressure to enhance atrial compliance.

[0017] In some respects, the technology described herein relates to an elastic appendage in which a first membrane and a second membrane form a fluid-impermeable seal.

[0018] In some respects, the techniques described herein relate to elastic appendages in which a cavity formed by a first membrane and a second membrane contains a fluid under internal pressure.

[0019] In some respects, the techniques described herein involve elastic appendages in which the internal pressure is greater than the low left atrial pressure and less than the high left atrial pressure.

[0020] In some respects, the techniques described herein involve resilient appendages, wherein the frame is located outside the second membrane.

[0021] In some respects, the technology described herein relates to an elastic appendage in which the second membrane comprises a non-compliant material.

[0022] In some respects, the technology described herein relates to a resilient appendage that also includes a plurality of barbs at the proximal end of the frame that are configured to anchor the resilient appendage at the opening of the left atrial appendage.

[0023] In some respects, the techniques described herein involve elastic appendages in which a frame is located inside a second membrane.

[0024] In some respects, the technology described herein relates to an elastic appendage in which the second membrane comprises a compliant material.

[0025] In some respects, the techniques described herein involve elastic appendages in which a second membrane is configured to bulge outward in response to high left atrial pressure.

[0026] In some respects, the technology described herein relates to a powered left atrial appendage (LAA) pump comprising: a pump configured for implantation in a patient's left atrial appendage, the pump including a frame with a sealing cap and an active element forming the pump, the active element being housed within the frame; a power source external to the patient's heart; 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 the left atrium during atrial contraction to enhance atrial blood flow and thereby enhance left ventricular filling.

[0027] In some respects, the technology described herein relates to a powered LAA pump in which the active elements include a balloon, a movable diaphragm, a plunger, or a piston.

[0028] In some respects, the technology described herein relates to a powered LAA pump in which electrical leads include a pressure sensor configured to provide feedback for controlling the activation timing of the pump.

[0029] In some respects, the techniques described herein relate to a powered LAA pump, wherein the pump is configured to displace blood from the LAA into the left atrium in response to a mean internal chamber pressure in the left atrium exceeding 15 mmHg.

[0030] In some respects, the technology described herein relates to a powered LAA pump in which the volume of blood pumped out is configured to be greater than about 15 mL.

[0031] In some respects, the technology described herein relates to a powered LAA pump in which the volume of blood pumped out is configured to be less than about 30 mL.

[0032] In some respects, the technology described herein relates to a powered LAA pump, wherein the shape of the pump is configured to change in response to energy supplied by a power source.

[0033] In some respects, the technology described herein relates to a powered LAA pump, wherein the frame comprises a shape memory alloy, and the application of electricity from a power source causes the frame to change the shape of the pump.

[0034] In some respects, the technology described herein relates to a powered LAA pump, wherein the active element includes an element that is activated using pneumatics.

[0035] In some respects, the technology described herein relates to a powered LAA pump, wherein the pump is configured to increase the A wave and reduce the V wave.

[0036] In some respects, the technology described herein relates to a left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant comprising: a compliance membrane; and a frame connected to the compliance membrane at a proximal end of the frame, the frame forming an elliptical shape suitable for implantation in a patient's LAA, wherein the compliance membrane is configured to effectively smooth the inner surface of the LAA, wherein the compliance membrane is configured to provide pressure-mediated radial expansion of the compliance membrane during atrial filling, and wherein the compliance membrane is configured to facilitate the ejection of blood from the LAA into the left atrium during left atrial contraction.

[0037] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to cover a frame extending from the LAA orifice to the LAA neck.

[0038] In some respects, the technology described herein relates to an LAA implant in which a compliant membrane is configured to be positioned at the opening of the LAA.

[0039] In some respects, the techniques described herein relate to LAA implants, wherein the LAA implant is configured to replace volume to increase compliance, thereby reducing pressure in the left atrium.

[0040] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to bulge inward in response to increased left atrial pressure to allow blood to occupy a portion of the LAA within the frame.

[0041] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to return to the orifice in response to a decrease in left atrial pressure to drain blood from the LAA.

[0042] In some respects, the techniques described herein relate to an LAA implant in which a compliant membrane is configured to be compliant enough that it deforms in response to increased left atrial pressure to approach the distal end of the frame.

[0043] In some respects, the techniques described herein relate to LAA implants in which the amount of deflection of the compliant membrane is configured to correlate with the pressure in the left atrium.

[0044] In some respects, the technology described herein relates to LAA implants in which the frame comprises a shape memory alloy configured to curl during delivery and self-expand upon deployment.

[0045] In some respects, the technology described herein relates to a LAA implant in which the compliant membrane is configured to be impermeable to liquids.

[0046] In some respects, the technology described herein relates to a left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant comprising: a compliance membrane; and an annular frame portion coupled to the compliance membrane, the annular frame portion being configured to anchor at the opening of the patient's LAA, wherein the compliance membrane is configured to provide pressure-mediated radial expansion of the compliance membrane during atrial filling, and wherein the compliance membrane is configured to facilitate the ejection of blood from the LAA into the left atrium during left atrial contraction.

[0047] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to bulge inward into the LAA in response to high left atrial pressure.

[0048] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to return to the orifice after bulging inward into the LAA in response to low left atrial pressure, thus aiding in the ejection of blood from the LAA.

[0049] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to occlude the LAA.

[0050] In some respects, the techniques described herein relate to LAA implants, wherein the annular frame includes anchoring features to securely anchor to the mouth of the LAA.

[0051] In some aspects, the technology described herein relates to a left atrial appendage (LAA) compliant balloon configured to be implanted in the LAA to aid in the inflation and drainage of blood from the LAA. The LAA compliant balloon comprises: a balloon configured to be positioned within the LAA; and a tether connected to the balloon, configured to power the balloon to inflate and deflate it. During atrial diastole, the tether powers the balloon to deflate it to allow blood to enter the LAA, and during atrial systole, the tether powers the balloon to inflate it to drain blood from the LAA.

[0052] In some respects, the techniques described herein involve LAA compliant balloons, wherein a tether is attached to a fluid reservoir that is passively activated by hemodynamic pressure to inflate the balloon.

[0053] In some respects, the technology described herein relates to LAA compliant balloons, in which tethers are connected to a battery to power the balloon.

[0054] In some respects, the techniques described herein relate to LAA compliant balloons, wherein the balloon is configured to inflate and deflate via deformation of its internal structure.

[0055] In some respects, the techniques described herein involve LAA compliant balloons, wherein the inflation and deflation of the balloon are activated by intracardiac pressure.

[0056] In some aspects, the technology described herein relates to an elastic appendage configured for implantation in a patient's left atrial appendage (LAA), the elastic appendage comprising: a frame forming a ring at a proximal end; an elastic ring coupled to the ring formed by the frame; a plurality of panels coupled to the elastic ring; a central support hub coupled to the plurality of panels, the central support hub, the plurality of panels, and the elastic ring forming a first membrane at a 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. The frame is configured to fill the space in the left atrial appendage of the patient, wherein in a deployment configuration, a first membrane is configured to be located at or near a ring formed by the frame in response to low left atrial pressure, the low left atrial pressure causing the central hub support, multiple panels, and elastic ring to be located at or near the proximal end of the frame due to the spring pushing the rod proximally, and wherein, in a deployment configuration, the first membrane is configured to deflect inward into a cavity formed by the frame and a second membrane in response to high left atrial pressure to enhance atrial compliance, the high left atrial pressure pushing the multiple panels and elastic ring distally, the elastic ring pushing the rod distally to compress the spring, thereby regulating the inward deflection of the first membrane.

[0057] In some respects, the techniques described herein involve resilient appendages in which a frame is located within a second membrane.

[0058] In some respects, the techniques described herein involve elastic appendages in which a second membrane is within a frame.

[0059] In some respects, the techniques described herein involve elastic appendages in which a second membrane is configured to be non-compliant.

[0060] In some respects, the technology described herein relates to a resilient appendage in which multiple panels are rigid.

[0061] In some respects, the techniques described herein involve resilient appendages in which a plunger is formed at the distal end of the rod.

[0062] In some respects, the technology described herein relates to a resilient appendage in which multiple panels are rigid.

[0063] In some respects, the technology described herein relates to a sequential balloon pump comprising: a multi-segment balloon including multiple segments individually inflatable, the multi-segment balloon being configured for implantation in the left atrium; a power source; and a lead connecting the power source and the multi-segment balloon, the lead being configured to supply power from the power source to the multi-segment balloon, wherein the multi-segment balloon is configured to inflate and deflate upon activation of the power source to enhance atrial compliance.

[0064] In some respects, the techniques described herein relate to sequential balloon pumps, in which multiple segments of a multi-segment balloon are configured to inflate sequentially in an inflation sequence.

[0065] In some respects, the techniques described herein relate to sequential balloon pumps, in which multiple segments of a multi-segment balloon are configured to deflate sequentially in a deflating order.

[0066] In some respects, the techniques described herein involve sequential balloon pumps, in which the deflation sequence of multiple segments of a multi-segment balloon is the same as the inflation sequence.

[0067] In some respects, the techniques described herein involve sequential balloon pumps, wherein the inflation sequence is configured to push blood from the top of the left atrium toward the mitral valve annulus and into the left ventricle.

[0068] In some respects, the techniques described herein involve sequential balloon pumps, wherein the deflation sequence is configured to draw blood from the pulmonary veins and lungs to inflate the left atrium for subsequent heartbeats.

[0069] In some respects, the techniques described herein involve sequential balloon pumps, in which a multi-segment balloon is configured to inflate starting from the segment adjacent to the top of the left atrium among multiple segments.

[0070] In some respects, the techniques described herein involve sequential balloon pumps, in which a multi-segment balloon is configured to begin deflation from the segment adjacent to the top of the left atrium among multiple segments.

[0071] In some respects, the techniques described herein relate to sequential balloon pumps, in which multi-segment balloons are configured to expand and contract in response to energy received from a power source.

[0072] In some respects, the technology described herein relates to a sequential balloon pump that also includes a pressure element configured to provide pressure measurements used to time the operation of the sequential balloon pump.

[0073] In some respects, the techniques described in this paper involve sequential balloon pumps, in which multiple balloons inflate in response to the mean internal cavity pressure of the left atrium exceeding a threshold.

[0074] In some respects, the techniques described in this paper involve sequential balloon pumps, where the threshold is approximately 15 mmHg.

[0075] In some respects, the techniques described herein involve sequential balloon pumps, wherein the volume displaced by multiple balloon segments is at least 10 mL.

[0076] In some respects, the techniques described in this article involve sequential balloon pumps, in which a power source is implanted in the left atrial appendage.

[0077] In some respects, the techniques described herein involve sequential balloon pumps, wherein a multi-segment balloon comprises at least three segments.

[0078] In some aspects, the techniques described herein relate to a left atrial appendage (LAA) implant configured to enhance atrial compliance, the LAA implant comprising: a support structure configured to be implanted in a natural atrial appendage; a compliance 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 natural atrial appendage, wherein the compliance membrane is configured to respond to blood flow to ensure that the occlusion of the natural atrial appendage is effective and to help regulate blood flow, wherein the compliance membrane is configured to provide pressure-mediated radial expansion of the compliance membrane during atrial filling, and wherein the compliance membrane is configured to facilitate the ejection of blood from the LAA into the left atrium during left atrial contraction.

[0079] In some respects, the techniques described herein relate to LAA implants, wherein a support structure is configured to anchor at the opening of the patient's LAA.

[0080] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to bulge inward into the LAA in response to high left atrial pressure.

[0081] In some respects, the techniques described herein relate to LAA implants in which a compliant membrane is configured to return to the orifice after bulging inward into the LAA in response to low left atrial pressure, thus aiding in the ejection of blood from the LAA.

[0082] In some respects, the techniques described herein relate to LAA implants in which a combination of a sealing skirt and a compliant membrane is configured to occlude the LAA.

[0083] In some respects, the techniques described herein relate to LAA implants, wherein the support structure includes anchoring features to securely anchor to the mouth of the LAA.

[0084] In some respects, the technology described herein relates to an anticoagulant pouch for implantation in a patient's left atrial appendage (LAA), the anticoagulant pouch comprising: 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 into a peanut shape such that, in response to an increase in pressure, the frame changes into a more elliptical shape to enhance atrial compliance.

[0085] In some respects, the technology described herein relates to an anti-clotting bag, wherein the frame also includes barbs to facilitate implantation into the LAA.

[0086] In some respects, the techniques described herein relate to anticoagulant bags, wherein, in response to changes in pressure, the bag changes shape to provide compliance and enhance blood flushing.

[0087] In some respects, the technology described herein relates to an anticoagulant pouch for implantation in a patient's left atrial appendage (LAA), the anticoagulant pouch comprising: a fixation frame; an elliptical support; a conical portion connecting the fixation frame to the elliptical support; a distal sealing membrane connected to the distal end of the elliptical support; and a perforated cap connected to the fixation frame, the conical portion, and the elliptical support, wherein the fixation frame and the elliptical support are configured to change shape during systole and diastole, wherein the fixation frame and the elliptical support are biased into a peanut shape such that, in response to an increase in pressure, the frame changes to a more elliptical shape to enhance atrial compliance.

[0088] In some respects, the technology described herein relates to an anticoagulant bag, wherein a fixing frame is configured to anchor the anticoagulant bag at the opening of the LAA.

[0089] In some respects, the technology described herein relates to an anti-clot bag, wherein the elliptical support also includes anchors to secure the anti-clot bag within the LAA.

[0090] In some respects, the technology described herein relates to anti-clotting bags, wherein, in response to an increase in pressure, a distal end sealing member is configured to protrude away from the elliptical support to enhance compliance.

[0091] In some respects, the technology described herein relates to anticoagulant bags, wherein, in response to a decrease in pressure, the distal end sealing member is configured to relax from a convex state to an elliptical support to enhance blood flushing.

[0092] In some respects, the technology described herein relates to an anti-clotting bag in which the fixation frame and elliptical support comprise nickel-titanium.

[0093] In some respects, the technology described herein relates to an anticoagulant bag in which a fixing frame is radially opened relative to the central axis of the anticoagulant bag to extend over the LAA orifice.

[0094] In some respects, the technology described herein relates to an appendage wedge implant configured for implantation in a patient's left atrial appendage (LAA), the appendage wedge implant comprising: a cap defining a proximal opening; a wire spring that presses outward on the cap to define the shape of the proximal opening; and an anchoring barb configured to secure the appendage wedge implant to the LAA, wherein during diastole, the proximal opening is pressed into a flattened, narrow opening in response to a reduced pressure on the cap, causing the wire spring to press outward on the cap, wherein during systole, the proximal opening opens wider in response to an increased pressure on an inwardly pressing wire spring, thereby changing the shape of the opening to a wider one.

[0095] In some respects, the technology described herein relates to an appendage wedge implant in which a wire spring is configured to press outward along both edges to flatten the appendage wedge implant under diastolic pressure.

[0096] In some respects, the technology described herein relates to an appendage wedge implant, wherein a volume change in the appendage wedge implant caused by the interaction of a wire spring with the cap to change the volume within the cap is configured to increase atrial compliance during the cardiac cycle.

[0097] In some respects, the technology described herein relates to an internal compliance aid configured for implantation in a patient's left atrial appendage (LAA), the aid comprising: a C-clamp configured for implantation in the LAA, wherein during high pressure, the C-clamp is compressed to open the opening of the LAA, and wherein during low pressure, the C-clamp is pressed outward on the LAA to flatten the opening of the LAA.

[0098] In some respects, the technology described herein relates to a device in which a C-clamp is configured to store energy during peak LA pressure and to compress during low pressure.

[0099] In some respects, the technology described herein relates to a magnetic device configured for implantation in a patient's left atrial appendage (LAA), the device comprising: a first magnet implanted on a first side of the LAA; and a second magnet implanted on a second side of the LAA, the second side opposite the first side, wherein during atrial diastole, pressure pushes the first and second magnets apart, wherein during atrial systole, a decrease in pressure causes the first and second magnets to approach each other, wherein the corresponding movement of the first and second magnets, combined with the magnetic force between the first and second magnets, is configured to enhance atrial compliance and aid blood flushing.

[0100] In some respects, the technology described herein relates to a device that also includes a scaffold implanted between a first magnet and a second magnet.

[0101] In some respects, the technology described herein relates to a device configured for implantation in a patient to enhance atrial compliance, the device comprising: a first stent configured for implantation at a first location in the patient's heart; a second stent to be implanted at a second location in the patient's heart; and a spring attaching the first stent to the second stent, wherein the spring is configured to stretch and contract according to pressure during the cardiac cycle to enhance the filling and ejection of blood in the left atrium.

[0102] In some respects, the technology described herein relates to a device in which a first location is a pulmonary vein and a second location is a left atrium.

[0103] In some respects, the technology described herein relates to a device in which a first position is the left atrial appendage (LAA) and a second position is the wall of the left atrium (LA) opposite the LAA.

[0104] In some respects, the technology described herein relates to a device in which a second support includes an anchor attached to a second location.

[0105] In some respects, the technology described herein relates to a device in which the first support is an occluder.

[0106] In some respects, the technology described herein relates to a device configured to be implanted in a patient's left atrial appendage (LAA) to enhance atrial compliance, the device comprising: a membrane that is flexible around an opening of the LAA at its periphery, wherein the device is configured to provide in-plane deflection of the membrane during a cardiac cycle by deflecting outward and in-plane with the LAA opening.

[0107] In some respects, the technology described herein relates to a device in which a membrane is configured to resemble an atrial wall that extends in two dimensions in the plane of the LAA orifice rather than perpendicular to it.

[0108] In some respects, the technology described herein relates to a device in which a membrane is attached to an opening.

[0109] In some respects, the technology described herein relates to a device in which a membrane is used as an occluder.

[0110] In some respects, the technology described herein relates to a device in which the membrane does not deflect into or out of the LAA.

[0111] In some respects, the technology described herein relates to a closure device for a patient's left atrial appendage (LAA), the closure device comprising: an expandable cylindrical frame; a first sealing cloth covering the circumference of the expandable cylindrical frame; a second sealing cloth coupled to the distal edge of the expandable cylindrical frame; and a flushing mechanism coupled to the proximal edge of the expandable cylindrical frame, wherein the flushing mechanism is configured to enhance blood flow from the internal volume of the expandable cylindrical frame.

[0112] In some respects, the technology described herein relates to a closing device in which the flushing mechanism includes a pair of sails configured to function as a duckbill valve.

[0113] In some respects, the technology described herein relates to a closure device in which, during contraction, a pair of sails move closer to each other and flush blood from the internal volume of an expandable cylindrical frame, and during relaxation, the pair of sails move away from each other and fill the internal volume with blood.

[0114] In some respects, the technology described herein relates to a closure device in which a pair of sails are fixed at the distal end edge and the proximal edge of an expandable cylindrical frame, and the material of the pair of sails between the distal end edge and the proximal edge is configured to move and change shape.

[0115] In some respects, the technology described herein relates to a closure device in which the flushing mechanism includes: a support rod coupled to a proximal edge of an expandable cylindrical frame and extending within an internal volume toward a distal edge of the expandable cylindrical frame; and a set of flexible membranes coupled to the support rod, each of the membranes being configured to change geometry in response to pressure changes during a cardiac cycle.

[0116] In some respects, the techniques described herein relate to a closure device in which changes in geometry improve blood flow within the closure device.

[0117] In some respects, the technology described herein relates to a closure device in which an internal volume is configured to retain blood volume within the LAA and to provide a flushing mechanism for the blood volume to inhibit thrombus formation.

[0118] In some respects, the technology described herein relates to a closure device in which each membrane comprises nitinol shaped yarns encapsulated with ePTFE, including an ePTFE membrane, or nitinol braids encapsulated with ePTFE.

[0119] In some respects, the techniques described herein relate to a closure device that is configured to reduce the risk of blood clot formation not by blocking the LAA, but by increasing the blood flow to and from the LAA.

[0120] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features have been described. It should be understood that not all of these advantages can necessarily be achieved according to any particular embodiment. Therefore, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages of the teachings herein, without necessarily achieving other advantages of the teachings or suggestions herein. Attached Figure Description

[0121] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of this disclosure. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments that are part of this disclosure. Throughout the drawings, reference numerals may be repeatedly used to indicate correspondences between reference elements.

[0122] Figure 1A , Figure 1B , Figure 1C and Figure 1D An example of an elastic appendage constructed for implantation in the left atrial appendage (LAA) is shown.

[0123] Figure 2 Another example of an elastic appendage constructed to be implanted in an LAA is shown.

[0124] Figure 3A , Figure 3B , Figure 3C , Figure 3D , Figure 3E and Figure 3F Examples are shown for using Figure 2 An example of the process of implanting elastic appendages into a LAA.

[0125] Figure 4 An example of a powered LAA pump configured to be implanted in a LAA is shown.

[0126] Figure 5A and Figure 5B An example of an LAA implant is shown, which is configured to be implanted in an LAA to enhance atrial compliance.

[0127] Figure 6A , Figure 6B and Figure 6C An example of an LAA membrane configured to be implanted at the opening of the LAA is shown.

[0128] Figure 7A and Figure 7BAn example of a LAA compliant balloon is shown, which is configured to be implanted in the LAA to help drain blood from the LAA.

[0129] Figure 8A , Figure 8B and Figure 8C Another example of an elastic appendage configured for implantation in a LAA is illustrated, which includes a spring-loaded panel to enhance atrial compliance.

[0130] Figure 9A , Figure 9B , Figure 9C and Figure 9D An example of a sequential balloon pump with a multi-segment balloon connected to a power source via leads is shown.

[0131] Figure 10 An example is an elastic appendage comprising a sealing skirt and a compliant membrane having a structural frame.

[0132] Figure 11A , Figure 11B , Figure 11C , Figure 11D and Figure 11E An example implementation of an anticoagulant pouch for implantation in a LAA is illustrated.

[0133] Figure 12A , Figure 12B , Figure 12C , Figure 12D , Figure 12E , Figure 12F , Figure 12G , Figure 12H , Figure 12I and Figure 12J Examples of deformable LAA implants configured to enhance atrial compliance are illustrated.

[0134] Figure 13A , Figure 13B , Figure 13C , Figure 13D , Figure 13E and Figure 13F An example of a deformable LAA implant with a deformable scaffold is shown.

[0135] Figure 14A , Figure 14B and Figure 14C Another example of a deformable LAA implant is illustrated, in which the fixation frame and the deformable scaffold are formed as separate components and then connected to each other.

[0136] Figure 15A , Figure 15B , Figure 15C , Figure 15D , Figure 15E , Figure 15F , Figure 15G and Figure 15H Another deformable LAA implant suitable for having a significantly longer sealing area is illustrated.

[0137] Figure 16A , Figure 16B , Figure 16C , Figure 16D , Figure 16E and Figure 16F An example of an end-deformable stent is illustrated, which is configured to be implanted in the LAA to enhance atrial compliance.

[0138] Figure 17A and Figure 17B An example is shown of an appendage wedge configured to be implanted in an LAA.

[0139] Figure 18 An internal compliance aid is illustrated, which is configured to store energy during peak LA pressure and squeeze during low pressure.

[0140] Figure 19A , Figure 19B , Figure 19C , Figure 19D and Figure 19E An example is a magnetic device configured to enhance the compliance of the LA by pressing the wall of the LAA.

[0141] Figure 20A , Figure 20B and Figure 20C Another example device configured to enhance atrial compliance is illustrated.

[0142] Figure 21A , Figure 21B , Figure 21C and Figure 21D An example is shown of a device configured to provide in-plane deflection using a membrane.

[0143] Figure 22A and Figure 22B An example implementation of an LAA closure device with a flushing mechanism is illustrated.

[0144] Figure 23A , Figure 23B , Figure 23C , Figure 23D , Figure 23E and Figure 23F Another example implementation of an LAA closure device with a flushing mechanism is illustrated. Detailed Implementation

[0145] The headings provided in this document are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter.

[0146] Overview

[0147] Diastolic dysfunction is an organ condition that occurs when the heart's main pumping chambers (ventricles) become "stiff." This stiffness hinders the heart's ability to fill with blood between heartbeats. As a result, the heart does not fill with as much blood as a healthy heart and / or pumps less blood to the rest of the body.

[0148] Diastolic dysfunction of the heart is characterized by high left-sided filling pressure in the left ventricle. Additionally, there is elevated pressure in the left atrium, as measured by increased postcapillary wedge pressure (PCWP) at rest and during exertion. As left atrial pressure increases, the walls of the left atrium dilate and stretch into a less substantially compliant state. In other words, there is a loss of elasticity in the myocardium of the dilated left atrium to absorb the temporary increase in left atrial pressure. The net effect is the return of blood from the left atrium to the pulmonary veins, and subsequently to the capillary bed of the lung parenchyma. This increase in pressure in the pulmonary vascular system causes water to wash away from the alveoli, resulting in pulmonary congestion and shortness of breath. If left uncontrolled, diastolic dysfunction can develop into diastolic heart failure.

[0149] Therefore, this paper discloses apparatus and methods for addressing elevated left-sided filling pressure to mitigate the effects of diastolic dysfunction. Various implementations provide ways to reduce the temporary increase in blood flow and pressure (which is expelled from the body) from the venous system into the heart. Under exertion, blood shifts from “non-stress” reservoirs in the vascular system (primarily including visceral systems such as the liver, spleen, and intestines) to “stress” reservoirs (including the heart and lungs). By inhibiting or preventing this abrupt shift of blood from “non-stress” reservoirs to “stress” reservoirs, unintended surges of blood volume into an already overloaded left heart can be avoided. Some implementations provide ways to maintain, enhance, or increase atrial compliance or atrial elasticity. This increase or enhancement of atrial compliance allows the atria to “absorb” the energy of brief bursts of high left-sided atrial pressure. The result of such implementations is reduced reflux in the pulmonary veins to inhibit or prevent acute pulmonary congestion.

[0150] The techniques disclosed herein provide a variety of ways to inhibit or prevent the propagation of elevated pressure from the left heart to the pulmonary vascular system. This can be achieved by enhancing atrial compliance to address the time-dependent increase in left atrial pressure. The disclosed techniques implement various devices and systems for enhancing atrial compliance using the left atrial appendage (LAA). Examples of these techniques include balloons and balloon pumps, LAA occluders with compliant membranes, stents with compliant components implanted in the LAA, compliant materials implanted in the LAA, diaphragms bent into the LAA, etc., using the LAA in a manner to increase left heart compliance during filling and emptying.

[0151] Advantageously, improving left atrial compliance can suppress or prevent the adverse effects of diastolic dysfunction. For example, diastolic dysfunction can reduce left atrial compliance, meaning that the pressure in the same volume of the left atrium is reduced. Patients may experience elevated left atrial pressure (associated with many adverse symptoms and poor prognosis), which can develop into heart failure. Increasing or enhancing atrial compliance leads to the atria receiving more blood, which may result in beneficial outcomes such as reduced return to the lungs.

[0152] In some implementations, the disclosed technique can be used as an alternative to shunt the left atrium. This can be advantageous because it does not introduce oxygenated blood into the left atrium.

[0153] In some embodiments, the disclosed techniques are configured to respond to pressure and / or pressure differentials in the heart. For reference, a typical cardiac cycle results in the removal of approximately 14 mL to approximately 18 mL of blood with each heartbeat. Therefore, in order to provide a clinically significant pressure drop, the disclosed techniques can be configured to provide a similar volume removal. For example, a device implanted in the left atrial appendage (LAA) can be configured to remove a volume within a target range (e.g., approximately 14 mL to 18 mL).

[0154] Elastic appendages in the left atrial appendage

[0155] Figure 1A , Figure 1B , Figure 1C and Figure 1D An example of an elastic appendage constructed for implantation in LAA 16 is shown. Figure 1A and Figure 1B A first embodiment of the elastic appendage 140a is illustrated, and Figure 1C and Figure 1D A second embodiment of the elastic appendage 140b is illustrated.

[0156] refer to Figure 1A and Figure 1B The elastic appendage 140a includes a first membrane 142, a second membrane 144, and a frame 146 coupled to the first membrane 142 and the second membrane 144, wherein the frame 146 is within the second membrane 144. (Reference) Figure 1C and Figure 1DThe elastic appendage 140b includes a first membrane 142, a second membrane 144, and a frame 146 coupled to the first membrane 142 and the second membrane 144, wherein the frame 146 is located outside the second membrane 144. The internal cavity formed by the first membrane 142, the second membrane 144, and the frame 146 may be filled with a low-pressure gas or fluid. For the elastic appendages 140a and 140b, both the first membrane 142 and the second membrane 144 are configured to be compliant. In some embodiments, the first membrane 142 is configured to be softer or more compliant than the second membrane 144. In some embodiments, the first membrane 142 is compliant, and the second membrane 144 is non-compliant, in which case the frame 146 is located outside the second membrane 144. For the first membrane 142 and the second membrane 144, the material can be any suitable hyperelastic and / or compliant material, such as thin silicone rubber. Additionally, the frame 146 can be any suitable material, including, for example, shape memory alloys such as nitinol. The frame 146 may form a ring at the proximal end of the elastic appendages 140a, 140b, the ring being configured to support the first membrane 142 in such a way that the first membrane 142 extends freely into the cavity formed by the second membrane 144 and the frame 146. For example, this is in Figure 1B and Figure 1D Example in.

[0157] Figure 1A and Figure 1C Examples of elastic appendages 140a and 140b under low left atrial pressure conditions are illustrated. In this case, the first membrane 142 may be flush with or flat against the ring formed by the frame 146. In some embodiments, the first membrane 142 is configured to partially deform into the space formed by the second membrane 144 and the frame 146 under low left atrial pressure conditions. In such embodiments, the first membrane 142 is configured to deform more completely into the space formed by the second membrane 144 and the frame 146 under high left atrial pressure conditions.

[0158] Figure 1B and Figure 1D Examples of elastic appendages 140a and 140b are illustrated under conditions of high left atrial pressure. In this case, 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 for greater deformation of the first membrane 142. In embodiments where the second membrane 144 comprises 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 not to move outward or bulge.

[0159] The resilient appendages 140a and 140b are configured for delivery via a transcatheter delivery system that passes through the interatrial septum and is advanced into the distal end pocket of the LAA 16. The delivery catheter retracts, and the resilient appendages 140a and 140b self-expand to occupy the volume of the LAA 16. The delivery catheter is then removed from the body.

[0160] Frame 146 may be a self-expanding frame structure. In some embodiments, frame 146 may be elliptical in shape, with one end flat (front) and a circular or rounded cross-section to conform to the opening of LAA 16, and the other end tapering to a blunt point. In some embodiments, frame 146 includes a plurality of serrations (e.g., between about 4 and 10 serrations) that span the length of the resilient appendages 140a, 140b in a curved geometry and terminate at a common blunt point. This point may be configured to be near the deepest point in LAA 16. The proximal ends of the serrations are attached to loops formed of shape memory material of frame 146. One or more loops may also be present along the length of frame 146 surrounding the serrations to reinforce the structure of frame 146. Additionally, frame 146 may have barbs or features to anchor the component to the LAA upon delivery.

[0161] The first membrane 142 is configured to be impermeable to gases and fluids (e.g., air and saline solution) and covers the flat end of the frame 146. The second membrane 144 is configured to have less elasticity (or greater rigidity) relative to the first membrane 142. The second membrane 144 is also configured to be impermeable to gases and fluids (e.g., air and saline solution). The second membrane 144 is configured to wrap around the circumference of the frame 146 and extend from the flat end to a blunt tapering end, thereby forming a balloon and sealing it in a fluid (e.g., gas or liquid). In some embodiments, a fabric is applied to the outer periphery of the flat end of the elastic appendages 140a, 140b, which is configured to seal to the opening of the LAA and promote endothelialization.

[0162] Because the first membrane 142 and the second membrane 144 are configured to be sealed within the fluid, inward movement of the first membrane 142 causes the second membrane 144 to bulge radially. This interaction between the first membrane 142 and the second membrane 144 enables the elastic appendages 140a, 140b to handle temporary increases in pressure. This is achieved by allowing blood to occupy a larger volume, thereby suppressing the increase in pressure. An advantage of the elastic appendages 140a, 140b is that the frame 146 can be adapted to different shapes of the LAA 16 found in patients.

[0163] The resilient appendages 140a and 140b include a flexible membrane (first membrane 142) attached to the edge of the frame 146 (e.g., the proximal annular portion of the frame 146). The resilient appendages 140a and 140b are filled with a compressible fluid (e.g., liquid or gas). This allows the first membrane 142 to move into and out of the left atrium in response to changes in left atrial pressure. The support structure for the resilient appendages 140a and 140b may be in the form of a covered stent (where the stent is the frame 146 and the cap is the second membrane 144) or a support for a bag-like 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 inflate during systole and deflate during diastole. In some cases, the second membrane 144 is oversized within the LAA 16 to obtain additional volume.

[0164] In some embodiments, the first membrane 142 may extend into the left atrium to increase atrial pumping, thereby forcing blood into the left ventricle. The first membrane 142 may extend inward and outward with the natural contraction and relaxation strokes. This advantageously adds new volume to the system to achieve a pressure drop. Bidirectional volume expansion and deflation can be achieved using a soft membrane for controlling the pressure accumulation curve and peak value. Thus, the first membrane 142 is deflected into the left atrium and LAA 16. That is, the first membrane 142 may be configured to deflect across the portacaval plane into the left atrium.

[0165] During contraction, the first membrane 142 expands inward (e.g., toward the cavity formed by the frame 146) using a pressure vector to fill the expanded volume of the LAA 16. This creates a pressure drop during the peak of contraction as the new volume is added to the system. During diastole, the first membrane 142 changes direction and expands toward the left atrium. The volume of the left atrium is now reduced and the pressure rises instantaneously. The pressure value causing the change of direction can be controlled by customizing the geometry and thickness of the first membrane 142. In some embodiments, spring-loaded struts may be added to support the device structure and dynamics.

[0166] Figure 2Another example of an elastic appendage 240 configured for implantation in a LAA 16 is illustrated. Similar to elastic appendage 140b, elastic appendage 240 includes a first membrane 242, a second membrane 244, and a frame 246 coupled to the first membrane 242 and 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, for example, at or near an opening. The internal cavity formed by the first membrane 242, the second membrane 244, and the frame 246 may 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 embodiments, the first membrane 242 is configured to be softer or more compliant than the second membrane 244. In some embodiments, the first membrane 242 is compliant and the second membrane 244 is non-compliant, in which case the frame 246 is located outside the second membrane 244. For both the first membrane 242 and the second membrane 244, the material can be any suitable hyperelastic and / or compliant material, such as thin silicone rubber. Additionally, the frame 246 can be any suitable material, including, for example, shape memory alloys such as nitinol. The frame 246 may form a ring at the proximal end of the elastic appendage 240, which is configured to support the first membrane 242 such that the first membrane 242 extends freely into the cavity formed by the second membrane 244 and the frame 246.

[0167] Figure 3A , Figure 3B , Figure 3C , Figure 3D , Figure 3E and Figure 3F Examples are shown for using Figure 2 An example of the process of implanting the elastic appendage 240 into LAA16. Figure 3A An example is a delivery catheter 310 that is advanced through the interatrial septum to the opening of LAA 16. An elastic appendage 240 is used for delivery in a delivery configuration, wherein a frame 246 and a second membrane 244 are rolled downwards to fit within the delivery catheter 310.

[0168] Figure 3B An internal conduit 312 is illustrated, which extends the resilient appendage 240 out of the delivery conduit 310 to change the resilient appendage 240 from a delivery configuration to a deployment configuration. A frame 246 is configured to expand when extended from the delivery conduit 310. For example, the frame 246 may be a wireframe comprising a shape memory alloy, such as nitinol. When the frame 246 expands, the second membrane 244 also expands, at least in part, due to its attachment to the frame 246.

[0169] Figure 3CThe resilient appendage 240 is illustrated as being completely discharged from the delivery catheter 310 via the internal conduit 312. This releases a plurality of barbs 241 at the proximal end of the resilient appendage 240, which are engaged with the frame 246. The frame 246 continues to expand to fill the space within the LAA 16. In some embodiments, the internal conduit 312 may be configured to inflate the second membrane 244 with a fluid, such as a liquid or gas. After the resilient appendage 240 has been discharged, withdrawal of the delivery catheter 310 can begin.

[0170] Figure 3D The example illustrates the release of the resilient appendage 240 from the internal conduit 312 and the retraction of the delivery conduit 310. Multiple barbs 241 are configured to anchor to the LAA 16 to secure the resilient appendage 240 within the LAA 16.

[0171] 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 remain substantially flat under low pressure. In some embodiments, the pressure of the fluid within the cavity may be configured to deflect the first membrane 242 into the left atrium under low pressure.

[0172] Figure 3E An example of the elastic appendage 240 in the presence of 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 substantially flat and flush with the ring formed by the frame 246. In some embodiments, in response to low atrial pressure, the first membrane may extend into the left atrium to provide atrial pumping to help push blood into the ventricles.

[0173] Figure 3F An example of the elastic appendage 240 is illustrated when the left atrial pressure is higher than the internal pressure of the fluid within the cavity of the elastic appendage 240. In this case, 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 problems caused by elevated left atrial filling pressure. Advantageously, this can mitigate the effects of diastolic dysfunction.

[0174] Power LAA pump

[0175] Figure 4An example is illustrated of a powered LAA pump 440 configured for implantation in an 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 may be configured similarly to an LAA occluder device, with additional functionality provided by the active element 442. In some embodiments, the active element 442 includes a flexible or movable element, such as a plunger or balloon.

[0176] A powered LAA pump 440 can be implanted into the LAA 16 using a transseptal approach. An electrical lead 446 can be led from the LAA 16 to a power source 448. The power source 448 can be placed in a subcutaneous space, with the electrical lead 446 passing through a venous access and via transseptal puncture.

[0177] The powered LAA pump 440 includes a frame (e.g., a nitinol wire cage) with a sealed cap, forming the pump. Inside the frame is an active element 442 (e.g., a balloon, a movable membrane, a plunger, a piston, etc.) configured to divert blood from the LAA 16 into the left atrium during atrial contraction. This increases atrial pumping or wave pressure to enhance left ventricular filling. In some embodiments, the electrical lead 446 includes a pressure sensor that allows feedback for controlling the activation timing of the active element 442. In some embodiments, additional atrial pumping from the LAA 16 to increase left ventricular filling occurs when the mean internal chamber pressure of the left atrium exceeds a threshold (e.g., at least about 15 mmHg or between about 10 mmHg and about 20 mmHg). The volume discharged by the powered LAA pump 440 can be between about 15 mL and about 30 mL, at least in part based on the size of the LAA 16.

[0178] The powered LAA pump 440 is configured to increase A waves and decrease V waves in patients with diastolic dysfunction. Increased A waves advantageously increase the amount of blood pushed into the left ventricle and decreased V waves. A waves are increased by pushing the pump outward into the left atrium using the active element 442. Furthermore, the available volume in the left atrium decreases, left atrial compliance increases, and V waves decrease. In some embodiments, the active element 442 includes an element activated using pneumatics. In some embodiments, the shape of the powered LAA pump 440 is influenced by the application of power, for example, by a shape memory alloy. For example, when the active element 442 comprises a shape memory alloy, the shape of the powered LAA pump 440 can be changed from a disc to a rod shape by applying electricity to the active element 442. Other methods can be used 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 a wire to change the shape of the powered LAA pump 440, using an electromagnet to push a portion of the powered LAA pump 440 out of the LAA 16, etc.

[0179] Left atrial appendage implant

[0180] Figure 5A and Figure 5B A passive LAA implant 540 is illustrated, which is configured to be implanted into LAA 16 via a transseptal approach to enhance atrial compliance. The passive LAA implant 540 includes a compliant elastic material implanted in LAA 16 to smooth the inner surface of LAA 16. The passive LAA implant 540 is shaped to fit a specific LAA anatomy and may be “finger-like,” extending from the LAA orifice to the distal portion (or “neck”) of LAA 16. The passive LAA implant 540 is configured to improve the efficiency of blood flow in and out of LAA 16, thereby improving effective left atrial compliance and inhibiting or preventing thrombus formation within LAA 16 (where heterogeneous topology of the LAA wall is a factor in thrombus formation). Additionally, the passive LAA implant 540 may be configured to provide pressure-mediated radial expansion of the material during atrial filling, resulting in more blood ejected from LAA 16 into the left atrium during left atrial contraction.

[0181] The passive LAA implant 540 includes a compliance membrane 542 covering a frame 544 that extends from the orifice of the LAA 16 to the neck. The compliance membrane 542 is configured to be positioned at or near the orifice of the LAA 16. The passive LAA implant 540 is configured to displace volume to increase compliance, thereby reducing pressure in the left atrium. Figure 5B As shown, under elevated pressure (e.g., 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 boundaries of the frame 544. As the pressure decreases, the compliant membrane 542 returns to the orifice, thereby draining blood from the LAA 16. The compliant membrane 542 is attached to the frame 544 at its proximal end, which is configured to be located at or near the orifice of the LAA 16. As the pressure increases, the compliant membrane 542 deforms to approach the distal end of the frame 544, thereby effectively increasing the volume of the left atrium with increasing pressure. In some embodiments, the amount of deflection of the compliant membrane 542 relative to the frame 544 may be correlated with the pressure in the left atrium. In some embodiments, the frame 544 comprises a shape memory alloy configured to curl during delivery and self-expand upon deployment. In some embodiments, the compliant membrane 542 is configured to be impermeable to liquids to more effectively deflect and facilitate the ejection of blood from LAA16. In some embodiments, the frame 544 is configured to be rigid.

[0182] In some embodiments, the passive LAA implant 540 includes an annular frame portion (e.g., formed by frame 544) and a distal frame portion (e.g., a 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 a compliance membrane 542 may extend. The compliance membrane 542 is coupled to the annular frame portion. The compliance membrane 542 extends into the cavity formed by the distal frame portion to provide pressure-mediated radial expansion of the compliance membrane during atrial filling. The annular frame portion is configured to anchor at the orifice of the LAA 16. The annular frame portion may include anchoring features to securely anchor to the orifice of the LAA 16.

[0183] Left atrial tympanic membrane

[0184] Figure 6A , Figure 6B and Figure 6C An example of an LAA membrane 640 configured for implantation at the orifice of an LAA 16 is illustrated. The LAA membrane 640 includes an annular frame 642 configured to be anchored to the LAA orifice. The annular frame 642 supports a compliant membrane 644. Figure 6B As shown, increased 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 flush with the annular frame 642; this return-to-flush configuration facilitates the drainage of blood from the LAA 16. The LAA membrane 640 also serves to occlude the LAA 16. The annular frame 642 may be configured to include tissue-interlocking features or a nitinol frame.

[0185] The LAA membrane 640 is configured to be implanted at the LAA orifice via a transseptal route. As atrial filling and pressure increase, the compliant membrane 644 deforms into the LAA 16, thereby increasing effective left atrial compliance (because the LAA 16 cannot adequately promote left atrial filling and emptying in patients with left atrial myopathy or atrial fibrillation). When the left atrium empties into the left ventricle and the pressure in the left atrium decreases, the compliant membrane 644 is configured to return to its "resting" configuration. The return of the compliant membrane 644 to its resting configuration actively facilitates left atrial contraction.

[0186] Left atrial appendage compliant balloon

[0187] Figure 7A and Figure 7B An example of a LAA compliant balloon 740 is illustrated, which is configured to be implanted in a LAA 16 to assist in the inflation and drainage of blood in the LAA 16. The LAA compliant balloon 740 includes a balloon 742 adapted for positioning within the LAA 16 and a tether 744 for powering the balloon 742. Figure 7AAn example is shown where balloon 742 deflates during atrial diastole, allowing blood to be present in LAA 16. Figure 7B This illustrates how, during atrial contraction, balloon 742 inflates and drains blood from LAA 16.

[0188] Balloon 742 is placed within the LAA 16 and accessed via a transseptal approach. The shape of balloon 742 can be varied according to the anatomy of the patient's LAA 16. Balloon 742 inflates during left atrial systole to eject blood from the LAA 16, such as... Figure 7B As shown. During atrial diastole, balloon 742 deflates, which helps draw blood into LAA 16, as... Figure 7A As shown. In patients with left atrial myopathy (often associated with HFpEF and atrial fibrillation), loss of LAA contractility reduces its positive contribution to left atrial compliance. Active dilation and contraction of the LAA compliance balloon 740 increases left atrial compliance during systole and diastole.

[0189] The LAA compliant balloon 740 can be powered in several ways. For example, a gas or fluid reservoir passively activated by hemodynamic pressure to expand the balloon 742, or a power source such as a battery. A tether 744 can be attached to the gas or fluid reservoir and / or the power source. The reservoir or power source can be implanted intravascularly, externally, or subcutaneously (pneumatically). Inflation and contraction can also be performed by deformation of an internal nitinol structure activated by intracardiac pressure or (mechanically). In some embodiments, inlet and outlet valves can be combined to regulate the inflation and deflation of the balloon 742. In some embodiments, the tether 744 penetrates the left atrial wall to connect to the reservoir or power source. In some embodiments, the reservoir or power source is implanted intracardiacly such that the tether 744 does not penetrate the left atrial wall.

[0190] Spring-loaded panel elastic attachment

[0191] Figure 8A , Figure 8B and Figure 8C Another example is illustrated of an elastic appendage 840 configured for implantation in an LAA 16, the elastic appendage 840 including a spring-loaded panel to enhance atrial compliance. Similar to... Figure 1A and Figure 1B Elastic appendage 140a, Figure 1C and Figure 1D The elastic appendage 140b and Figure 2The resilient appendage 240 includes a second membrane 844 and a frame 846 coupled to the second membrane 844. The frame 846 may be inside the second membrane 844 (similar to resilient appendage 140a) or outside the second membrane 844 (similar to resilient appendages 140b, 240). The second membrane 844 is configured to be non-compliant. In some embodiments, the resilient ring 842, the plurality of panels 843, and the central support hub 841 form a structure having a similar function to the first membrane 142 of resilient appendages 140a, 140b and / or the first membrane 242 of resilient appendage 240.

[0192] Frame 846 is configured to form a ring at its proximal end, which is configured to support a resilient ring 842 coupled to frame 846. A plurality of panels 843 are coupled to the resilient ring 842. The plurality of panels 843 may be rigid or semi-rigid. The plurality of panels 843 are coupled to rod 845 via a central support hub 841. Rod 845 is configured to enter a spring housing 847, which houses a spring 848 that contacts the distal end of rod 845. In some embodiments, the distal end of rod 845 forms a plunger or other expansion to fit tightly within spring housing 847. Thus, spring housing 847 may be configured to guide movement of rod 845 and inhibit or prevent spring 848 from buckling under compression.

[0193] Figure 8B An example of an elastic appendage 840 under low left atrial pressure is illustrated. In this case, a spring 848 pushes a rod 845 proximally, causing the elastic ring 842 and multiple panels 843 to be substantially flush with the proximal end of the frame 846. Figure 8C An example of an elastic appendage 840 under high left atrial pressure is illustrated. In this configuration, the higher pressure pushes the elastic ring 842 and multiple 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 target low left atrial pressure and compress a target amount in response to a target high left atrial pressure. Doing so can improve atrial compliance to address problems associated with high left-side filling pressure. Advantageously, this can mitigate at least some of the effects of diastolic dysfunction.

[0194] In some embodiments, frame 846 includes a plurality of barbs configured to anchor the resilient appendage 840 within LAA 16, for example, at or near the opening. The internal cavity formed by the first membrane (including a central support hub 841, a resilient ring 842, and a plurality of panels 843), the second membrane 844, and frame 846 can be filled with a low-pressure gas or liquid. For the resilient ring 842, the material can be any suitable hyperelastic and / or compliant material, such as thin silicone rubber. Additionally, frame 846 can be any suitable material, including, for example, shape memory alloys such as nitinol. Frame 846 may form a ring at the proximal end of the resilient appendage 840, configured to support the resilient ring 842, allowing the first membrane to extend freely into the cavity formed by the second membrane 844 and frame 846.

[0195] Active left atrial sequential balloon pump

[0196] Figure 9A , Figure 9B , Figure 9C and Figure 9D An example of a sequential balloon pump 940 is illustrated, wherein multiple balloon segments 942 are connected to a power source 944 via leads 946. The power source 944 is illustrated as being implanted in an LAA 16, but the power source 944 can be implanted in other locations.

[0197] The sequential balloon pump 940 includes a multi-segment balloon 942, which is configured to inflate segmentally in the order of segments 1, 2, 3, and 4 to push blood from the top of the left atrium (near the pulmonary vein orifice) towards the mitral valve annulus and into the left ventricle. That is, segment 1 of the multi-segment balloon 942 inflates (e.g., Figure 9A (as shown), then segment 2 of the multi-segment balloon 942 is inflated (as shown). Figure 9B (as shown), then segment 3 of the multi-segment balloon 942 is inflated (as shown). Figure 9C (as shown), then segment 4 of the multi-segment balloon 942 is inflated (as shown). Figure 9D (As shown). Additionally, the multi-segment balloon 942 is configured to deflate in the same sequence, i.e., segment 1 deflates, then segment 2 deflates, and so on. The sequential balloon pump 940 may include an inflatable balloon (multi-segment balloon 942) or, instead of the multi-segment balloon 942, a molded nitinol structure that can expand and contract upon application of active energy (e.g., using a power source 944).

[0198] The sequential balloon pump 940 is configured to enhance atrial expulsion during atrial contraction to increase left ventricular filling. In some embodiments, a pressure element may be incorporated to time the operation of the sequential balloon pump 940, such that the sequential balloon pump 940 can be activated when the mean internal chamber pressure of the left atrium exceeds a threshold (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 may be configured in the range of about 10 mL to about 100 mL, depending in part on the size of the patient's left atrium. Furthermore, the sequential balloon pump 940 may be configured such that during the deflation of the multi-segment balloon 942, blood from the pulmonary veins and lungs is drawn in to inflate the left atrium for the next heartbeat.

[0199] In some embodiments, the multi-segment balloon 942 contains a varying number of segments. For example, the multi-segment balloon 942 may include at least two segments, at least three segments, at least five segments, at least six segments, and / or less than or equal to ten segments, etc. In some embodiments, all necessary electronics and power supplies are housed within a shell occupying the LAA, and some of these embodiments potentially integrate external charging capabilities via inductive charging from a device external to the body. In some embodiments, the inflation and deflation of the segments of the multi-segment balloon 942 are non-uniform. In some embodiments, the sequential balloon pump 940 includes a peristaltic balloon pump.

[0200] Elastic appendages with sealing skirts and conformable membranes

[0201] Figure 10 An example of an elastic appendage 1040 is shown, which includes a sealing skirt 1046 and a compliant membrane 1044 having a structural frame 1042. The structural frame 1042 supports the sealing skirt 1046 and the compliant membrane 1044. The compliant membrane 1044 may be a balloon or parachute element. The structural frame 1042 provides structural integrity, while the sealing skirt 1046 acts as a barrier to prevent blood from entering the LAA 16. The compliant membrane 1044 is adapted to adapt to and respond to blood flow, ensuring that the occlusion is effective and that blood flow is properly modulated. In some embodiments, the compliant membrane 1044 is configured to protrude both into and out of the LAA 16. Protruding from the LAA 16, the compliant membrane 1044 can provide atrial expulsion to help flush blood from the LAA 16 into the ventricles.

[0202] The structural frame 1042 includes a biocompatible expandable frame that conforms to the anatomy of the LAA 16, thereby providing structural stability. A sealing skirt 1046 is attached to the structural frame 1042 and is made of a flexible, biocompatible material. The sealing skirt 1046 is positioned at the distal end of the resilient appendage 1040 to prevent blood flow into the LAA 16, thereby effectively isolating it. The material of the sealing skirt 1046 may be compliant, ensuring a seal is formed against the inner surface of the LAA 16 to prevent or inhibit blood entry into the LAA 16.

[0203] The interior of the elastic appendage 1040 includes a compliant membrane 1044 adapted to accommodate blood inflow. When blood enters the elastic appendage 1040, it is guided into the compliant membrane 1044, which expands to allow temporary storage of blood. The elasticity of the compliant membrane 1044 allows it to return to its original state, pushing the 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.

[0204] The elastic appendage 1040 is designed for deployment via a transcatheter approach, which can be performed using transseptal or femoral artery access. The catheter delivers the elastic appendage 1040 to the desired location within the LAA 16, where the structural frame 1042 expands 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.

[0205] During 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 drained from the elastic appendage 1040, thereby preventing pooling and maintaining healthy circulatory dynamics.

[0206] The structural frame 1042 is designed not only for structural support but also to work in conjunction with the sealing skirt 1046 to ensure an effective seal. The interaction between the structural frame 1042 and the sealing skirt 1046 is designed to suppress or prevent leakage around the resilient appendage 1040, thereby enhancing its effectiveness in isolating the LAA 16. The expandable nature of the structural frame 1042 allows it to be adapted to the size and shape of the LAA 16, providing a customizable fit.

[0207] The design of the resilient appendage 1040 incorporates features that allow the device to deflect blood flow into the compliant membrane 1044, thereby ensuring effective blood management within the resilient 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 natural appendage after implantation. The ability of the resilient appendage 1040 to adapt to blood flow into the compliant membrane 1044 reduces pressure within the LAA 16, preventing blood stagnation and reducing the risk of thromboembolism. The transcatheter delivery method allows for minimally invasive implantation, reducing patient recovery time and surgical risks. The structural frame 1042 and the sealing skirt 1046 provide a robust and customizable fit, ensuring effective occlusion regardless of anatomical variability.

[0208] Anticoagulant bags

[0209] Figure 11A , Figure 11B , Figure 11C , Figure 11D and Figure 11E An example embodiment of an anticoagulant pouch 1140 for implantation in LAA 16 is illustrated. The anticoagulant pouch 1140 includes a plurality of frame members 1144 having a sealing membrane 1142 or cap. In some embodiments, the sealing membrane 1142 covers the distal end of the anticoagulant pouch 1140 and does not cover the proximal end of the anticoagulant pouch 1140 to form a pouch for the anticoagulant pouch 1140. The plurality of frame members 1144 are configured to change shape during contraction and relaxation, such as... Figures 11B to 11E As shown. Multiple frame members 1144 are biased into peanut or elliptical shapes, as... Figure 11B and Figure 11C As shown. Therefore, during low pressure, multiple frame members 1144 maintain an offset shape (or are slightly deformed relative to the offset shape). During increased pressure, multiple frame members 1144 change to a more rounded shape to enhance atrial compliance, as... Figure 11D and Figure 11E As shown.

[0210] The anticoagulant pouch 1140 may include barbs 1146 or other anchors for easy implantation into the LAA 16. In response to changes in pressure, the anticoagulant pouch 1140 changes shape. That is, the anticoagulant pouch 1140 opens (e.g., changing its shape from peanut-shaped or oval to round), providing compliance and enhancing blood flushing.

[0211] Deformable LAA implant with deformable scaffold and compliant distal septum

[0212] Figure 12A , Figure 12B , Figure 12C , Figure 12D , Figure 12E , Figure 12F , Figure 12G , Figure 12H , Figure 12I and Figure 12J An example of a deformable LAA implant 1240 configured to enhance atrial compliance is illustrated. The deformable LAA implant 1240 is characterized by a deformable stent 1246 that can transform between different configurations or shapes to accommodate changes in left atrial pressure and promote compliance and effective blood flushing. Similar to other implants and devices described herein, the deformable LAA implant 1240 is adapted to mimic the function of a healthy heart. That is, the deformable LAA implant 1240 expands and contracts to provide functionality similar to that of a stretchable or compliant LAA.

[0213] The deformable LAA implant 1240 also includes a distal sealing membrane 1248 coupled to the deformable stent 1246 to help enhance atrial compliance of the deformable stent 1246. The distal sealing membrane 1248 may be configured to protrude into the LAA 16 in response to increased pressure or high pressure in the left atrium. The deformable LAA implant 1240 includes a fixation frame 1242 that is radially open and configured to secure the deformable LAA implant 1240 against the opening of the LAA 16 in a sealing 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 closes at the distal end of the deformable LAA implant 1240. In some embodiments, the deformable stent may be a covered elliptical stent.

[0214] The deformable LAA implant 1240 is designed for deployment in the LAA. This stent changes between an elliptical and a circular configuration in response to varying left atrial (LA) pressure during systole and diastole of the cardiac cycle. This adaptive shape change facilitates blood flushing from the appendage while maintaining compliance with surrounding anatomy. The deformable stent 1246 is adapted to expand during atrial systole and contract during atrial diastole to enhance left atrial compliance, thereby improving cardiac function.

[0215] The deformable LAA implant 1240 includes a fixation frame 1242, a deformable support 1246, a tapered portion 1244, and a distal sealing membrane 1248. The fixation frame 1242 and / or the deformable support 1246 may include a nitinol wire frame. The deformable support 1246 is adapted to present a peanut-shaped or elliptical configuration. The deformable LAA implant 1240 includes a non-perforated cap covering the fixation frame 1242 and the deformable support 1246. The fixation frame 1242 is located at the proximal end of the deformable LAA implant 1240 and is adapted to anchor the deformable LAA implant 1240 within the LAA 16. In some embodiments, the deformable LAA implant 1240 also includes barbs to secure it to the LAA orifice. The deformable LAA implant 1240 forms a closed pouch for further sealing of the LAA using the distal sealing membrane 1248. The deformable LAA implant 1240 is a compliance-enhancing implant that includes an elliptical scaffold located inside the LAA, configured to change between its elliptical and circular configurations in response to changes in LA pressure during systolic and diastolic cycles.

[0216] The deformable LAA implant 1240 includes a deformable stent 1246 configured to extend through the LAA, a proximal attachment portion (e.g., a fixation frame 1242) configured to secure the deformable LAA implant 1240 against the opening of the LAA 16 (in a sealing manner), and a distal sealing membrane 1248 closed at the distal end to seal the portion of the LAA 16 closer to the pericardial side, thereby preventing clots that may form therein from flowing into the left atrium through the deformable stent 1246. The deformable stent 1246 may be elliptical, peanut-shaped, circular, and may include spring-like elements, etc. The fixation frame 1242 is covered by a cannula, which may be made of a clot-preventing material, wherein the tapered portion 1244 and the distal sealing membrane 1248 may be integral portions of the cannula covering the deformable LAA implant 1240 itself.

[0217] In some embodiments, the proximal attachment portion may include a fixation frame 1242 covered by the proximal portion of the cannula, wherein the fixation frame 1242 is radially flared relative to the central axis of the implant to extend over the LAA orifice 1211. The cannula surrounding the deformable stent 1246 adheres to the surrounding LAA wall 1215 such that during normal operation of the elliptical stent, as the LAA wall transforms between its elliptical and circular configurations, the LAA wall will move accordingly.

[0218] The deformable LAA implant 1240 can also be implemented using a proximal frame portion (e.g., a fixed frame 1242) and a distal frame portion (e.g., a deformable stent 1246). The distal frame portion has a smaller diameter than the proximal frame portion. In such embodiments, the distal frame portion is adapted to expand during atrial systole and contract during atrial diastole to enhance left atrial compliance. In some embodiments, the proximal and distal frame portions are separate frame portions joined together by a cap. In some embodiments, the proximal and distal stent portions are directly connected to each other. In some embodiments, the proximal and / or distal frame portions are formed of nitinol. In some embodiments, the proximal and / or distal frame portions are made of a braided, self-expanding material.

[0219] In some embodiments, the distal frame portion has an elliptical cross-section in the contracted state. In some embodiments, the distal frame portion has a concave surface before deployment in the LAA 16. In some embodiments, the distal frame portion has a substantially peanut-shaped cross-section before deployment in the LAA 16.

[0220] The proximal and distal frame portions can be covered by a cap extending along the proximal and distal frame portions, respectively. The cap is adapted to provide a seal at the distal end of the distal frame portion to prevent blood from flowing through the deformable LAA implant 1240. In some embodiments, the seal is flexible to enhance left atrial compliance during atrial contraction. In some embodiments, the seal is adapted to move proximally to enhance blood flushing of the interior of the deformable LAA implant 1240 during atrial diastole.

[0221] In some implementation schemes, implantation can be performed as a two-stage procedure, such as Figure 12H , Figure 12I and Figure 12J As shown. Figure 12H As shown, when using an expandable element (such as balloon 1212) delivered via delivery catheter 1210, a cannula 1216 is first adhered to the LAA 16. Subsequently, a deformable LAA implant 1240 is introduced into the cannula 1216 (at its intermediate portion). The method involves expanding the cannula 1216 above the balloon 1212 toward the LAA wall and adhering the cannula 1216 to the LAA 16 by injecting adhesive. The balloon 1212 can be held in its inflated state for a sufficient time during which the adhesive can cure. The balloon 1212 can then be deflated and retracted from the cannula 1216. Although balloon 1212 is shown, it should be understood that any other type of expansion member (such as a mechanical expansion member) can be contemplated. Thereafter, the deformable LAA implant 1240 can be advanced into the cannula 1216 and deployed against it, as... Figure 12IAs shown. The deformable LAA implant 1240 can be foldable to be advanced into the left atrial appendage via catheter insertion technique. The delivery catheter 1210 can be of sufficient length to advance the deformable LAA implant 1240 through the patient's vascular system, into the right atrium, and across the interatrial septum to reach the LAA 16.

[0222] In some embodiments, the cannula 1216 and the deformable LAA implant 1240 are not necessarily provided as separate components (e.g., the cannula 1216 may be positioned around and optionally attached to the deformable LAA implant 1240 to initiate implantation), and implantation may be performed as a staged procedure. While glue injection has been shown, it should be understood that adhesion can be achieved by any suitable procedure or institution. The deformable stent 1246 can be used to increase compliance as it transitions between its elliptical and more circular configurations in response to varying pressures during systole and diastole.

[0223] The sleeve 1216 and the deformable support 1246 can be designed to have an outer diameter of approximately 30 mm, wherein the sleeve 1216 has a length of approximately 25 mm and the deformable support 1246 has a length of approximately 15 mm (these dimensions are mentioned only by way of example). The change in cross-sectional area during the transition between the elliptical and circular configurations can be within 2 cm. 2 up to 3cm 2 Within a certain range, to promote pressure variation within the range of approximately 10 mmHg to approximately 40 mmHg. For example... Figure 12J As shown, blood contained in the distal portion of the LAA 16 between the deformable LAA implant 1240 (e.g., distal sealing membrane 1248) and the pericardial side of the LAA 16 can form a hardened thrombus-forming area that may affect compliance. To maintain desired tissue compliance and prevent such hardening, the implantation method may optionally include a preliminary step of draining blood from the portion of the LAA 16 sealed between the deformable LAA implant 1240 and the pericardial side of the LAA 16 using a suitable aspiration device. In some embodiments, the deformable LAA implant 1240 may also include a pressure sensor, which may optionally be mounted on the distal or proximal portion of the cannula 1216.

[0224] The deformable stent 1246 is adapted to transform between an elliptical (or peanut-shaped) configuration and a more circular configuration in response to pressure changes in the left atrium during systole and diastole of the cardiac cycle. This transformation provides compliance with the anatomy and promotes blood flushing, reducing the risk of thrombosis. A shape change occurs when the pocket within the deformable stent 1246 opens from the peanut-shaped configuration to a circular shape, thereby increasing its internal volume and compliance. This compliance feature ensures that the deformable LAA implant 1240 adapts to hemodynamics, reduces pressure buildup, and promotes effective circulation within the LAA.

[0225] The deformable LAA implant 1240 can be encased in a cap (e.g., a non-porous cap) that prevents blood from penetrating the structure and ensures complete occlusion of the LAA 16. The cap can be made of any suitable material, such as polyester. The deformable stent 1246 can be constructed using a peanut-shaped or oval nitinol wire frame. Nitinol allows for flexibility and shape memory properties, enabling the deformable stent 1246 to adapt to varying pressures. The proximal portion of the deformable LAA implant 1240 is characterized by a fixation frame 1242 that transforms into the deformable stent 1246 upon deployment, anchoring the deformable LAA implant 1240 to the LAA ostium. Barbs can be positioned along the fixation frame 1242 to firmly anchor the deformable LAA implant 1240 within the LAA ostium, thereby preventing migration and ensuring stability. A closed pouch 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 a distal sealing membrane 1248, which together provide a robust seal to prevent blood re-entry into the LAA 16. In some embodiments, the distal sealing membrane 1248, once implanted, can bulge distally in response to increased atrial pressure (e.g., during atrial contraction), such as... Figure 12H As shown. In response to reduced atrial pressure (e.g., during atrial diastole), the distal sealing membrane 1248 can move proximally to aid in the drainage of blood from the LAA 16. This movement of the distal sealing membrane 1248 helps to enhance left atrial compliance, thereby improving cardiac function. In some embodiments, the distal sealing membrane 1248 is adapted to remain relatively stationary so that it does not bulge significantly proximally or distally.

[0226] The device is configured to mitigate clot formation by promoting blood flow around the structure and preventing stagnation. The pouch also acts as a compliance zone to further adapt to hemodynamics within the left atrial appendage (LAA). The device includes a left atrial appendage cannula segmented into three distinct regions. The proximal region is configured for fixation to the orifice and to provide a seal at the attachment point. The intermediate region incorporates the device's compliance features and can be oval, peanut-shaped, or other spring-like configurations. This region can also contribute to the sealing function if desired. The distal region facilitates transition and contains a closed pouch to completely isolate the LAA from blood flow. The LAA cannula is made of an anti-clot-forming material, enhancing its effectiveness in preventing thrombosis within the appendage.

[0227] Deformable LAA implant with deformable scaffold

[0228] Figure 13A , Figure 13B , Figure 13C , Figure 13D , Figure 13E and Figure 13F An example of a deformable LAA implant 1340 having a deformable scaffold 1346 is illustrated. The deformable LAA implant 1340 is similar to... Figures 12A to 12J The deformable LAA implant 1240 differs from the deformable LAA implant 1340 in that it includes a longer proximal portion to improve the seal and anchorage of the LAA 16, and the deformable LAA implant 1340 does not include a distal sealing membrane.

[0229] The deformable LAA implant 1340 is a passive deformable scaffold structure covered by an impermeable elastic membrane. The deformable LAA implant 1340 is delivered into the LAA 16 via a series of nested entry and delivery catheters, thereby achieving self-expansion and anchoring and sealing to the orifice of the LAA. When in place, the deformable LAA implant 1340 has a circular cross-section that seals and anchors to the orifice of the LAA 16, and the distal cross-section of the deformable LAA implant 1340 has a collapsed geometry (e.g., peanut) as its cross-section, which is adapted to expand when pressure in the left atrium increases. Therefore, the deformable LAA implant 1340 is adapted to reduce the effective peak left atrial pressure. When the left atrial pressure decreases, the deformable LAA implant 1340 contracts back into a peanut shape, and blood is drawn from the implant pocket back into the left atrium, thereby inhibiting or preventing blood stasis in the deformable LAA implant 1340. This process repeats with each cardiac cycle, and its cumulative effect is to reduce left atrial pressure over time, thereby alleviating the symptoms of heart failure.

[0230] Figure 13AAn example is a deformable LAA implant 1340 with a cap. The deformable LAA implant 1340 includes a fixation frame 1342 having a tapered portion 1344 that transforms into a deformable support 1346 adapted to change shape between a flattened oval or peanut shape and a more rounded oval or more rounded shape. The cap may be an impermeable elastic membrane similar to other embodiments described herein. Figure 13B and Figure 13C Top and side views of a deformable LAA implant 1340 are illustrated, showing the underlying structure including a braided, self-expanding wire frame. In some embodiments, the deformable scaffold 1346 may be enclosed within a cylindrical cross-section to protect the dynamically deformable portion of the deformable LAA implant 1340 from the walls of the LAA tissue.

[0231] The deformable LAA implant 1340 includes a tapered portion 1344 between a deformable scaffold 1346 and a fixation frame 1342, the fixation frame 1342 having a radially outwardly flanged shape. The flanged portion of the fixation frame 1342 is configured to have relative rigidity for anchoring and sealing against the LAA 16. This contrasts with the deformable scaffold 1346, which is configured to move between an elliptical or peanut-shaped form and an expanded shape (e.g., a more rounded shape). The deformable scaffold 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 scaffold 1346 and is configured to have sufficient flexibility to suppress or prevent motion transmission between the deformable scaffold 1346 and the fixation frame 1342. Different behaviors of different portions of the braid can be achieved by varying the stiffness of the portions corresponding to the fixation frame 1342 and the deformable scaffold 1346. This can be achieved by varying the braid density and implementing an appropriate braid pattern between the filaments of the braid.

[0232] The deformable LAA implant 1340 is mechanically attached to the central lumen of the delivery catheter 1310, such as Figure 13DAs shown. The central lumen also serves as a means of draining blood from the distal portion of the LAA 16 after deployment of the deformable LAA implant 1340 (e.g., by aspiration at the operator's end via the lumen in the internal catheter). The delivery catheter 1310 comprises a larger external 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 threaded features (e.g., male / female threads on the tip of the internal catheter and the end of the deformable LAA implant 1340, respectively) or via other mechanical connections that can be removed during deployment of the deformable LAA implant 1340. When connected to the end of the internal catheter, the deformable LAA implant 1340 is adapted to collapse downward into the lumen of the larger external catheter. During deployment, the internal catheter is adapted to translate distal to the actuation device (operated by the surgeon), after which the deformable LAA implant 1340 is configured to exit the distal end of the external catheter and self-expand to the orifice of the LAA 16, as shown. Figure 13E As shown. The internal catheter is then disconnected from the deformable LAA implant 1340 and removed. The internal catheter is configured with an open lumen extending the catheter length. The lumen of the internal catheter is adapted to serve as a conduit for blood to be drawn from the other side of the deformable LAA implant 1340 within the cavity of the LAA 16. In some embodiments, a one-way valve (e.g., a duckbill valve) is present to allow blood to be drawn only in the direction away from the LAA 16.

[0233] 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 contraction, such as... Figure 13E As shown, and contracts during atrial diastole, such as Figure 13F As shown. This expansion and contraction of the distal frame portion enhances the compliance of the left atrium, thereby improving cardiac function.

[0234] Similar to the deformable LAA implant 1240, the deformable LAA implant 1340 can also be implemented using a proximal frame portion (e.g., a fixed frame 1342) and a distal frame portion (e.g., a deformable stent 1346), wherein 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 contract during atrial diastole to enhance left atrial compliance. The proximal and distal frame portions can be covered by a cap extending along the proximal and distal frame portions. The cap is adapted to provide a seal at the distal end of the distal frame portion to prevent blood from flowing through the deformable LAA implant 1340.

[0235] Figure 14A , Figure 14B and Figure 14CAnother example of a deformable LAA implant 1440 is illustrated, wherein a fixation frame 1442 (e.g., a proximal frame portion) and a deformable scaffold 1446 (e.g., a distal frame portion) are formed as separate components and then coupled to each other. The deformable LAA implant 1440 is similar to the deformable LAA implants 1240 and 1340 described herein. The deformable LAA implant 1440 also includes a tapered portion 1444 between the fixation frame 1442 and the deformable scaffold 1446. To couple the fixation frame 1442 to the deformable scaffold 1446, a suitable connector, such as a ring 1445 or other type of flexible connector, is used. The deformable scaffold 1446 may be formed from laser-cut nitinol, a material previously shown to be capable of proper movement between a compressed and expanded state. The fixation frame 1442 may be formed from a braided fabric.

[0236] It should be understood that, although the cap is not shown in some of the figures, the deformable LAA implant described herein is configured to include a cap above the deformable stent and the distal end portion.

[0237] Figure 15A , Figure 15B , Figure 15C , Figure 15D , Figure 15E , Figure 15F , Figure 15G and Figure 15H Another deformable LAA implant 1540 is illustrated, which is adapted to have a significantly longer sealing region compared to deformable LAA implants 1240, 1340, and 1440. A challenge with these deformable LAA implants is the relatively short sealing portion (e.g., the fixation frame and tapered portion), which makes it difficult to achieve a sufficient seal within the LAA. Therefore, deformable LAA implant 1540 includes a longer sealing region, such as sealing portion 1544. Deformable LAA implant 1540 does not include the flange fixation frame as seen in other deformable LAA implants described herein. This is because the axis of the LAA (and the implant extending therein) is not perfectly perpendicular to the opening, meaning that the fixation of deformable LAA implant 1540 can rely on anchors rather than a flange fixation frame to provide sufficient anchorage.

[0238] The deformable LAA implant 1540 includes an elongated cylindrical external sealing portion, namely a sealing portion 1544, configured to abut against and seal against the wall expansion of the LAA 16. The deformable LAA implant 1540 includes a deformable stent 1546 located within a lumen formed by the sealing portion 1544. The deformable stent 1546 is connected to the sealing portion 1544 via a transition portion 1542 extending between the proximal edge of the sealing portion 1544 and the proximal edge of the deformable stent 1546. The deformable LAA implant 1540 is covered by a membrane such that the sealing portion 1544 disposed on the deformable stent 1546 seals the LAA when the deformable stent 1546 can pump a volume of blood contained therein. This configuration advantageously provides a significantly longer and larger sealing area. In some embodiments, the deformable LAA implant 1540 is adapted to be delivered to the LAA in a compression configuration, in which the sealing portion 1544 is compressed over the deformable stent 1546.

[0239] Figures 15D to 15F Another delivery configuration is illustrated, in which the deformable support 1546 approaches the sealing portion 1544 during delivery. This can advantageously result in a smaller crimp profile. Upon arrival at the LAA, the sealing portion 1544 can expand against the LAA wall, as... Figure 15G As shown. The delivery catheter 1510 can then be used to push the deformable stent 1546 into the sealing portion 1544 (the deformable stent retains its position due to being anchored to the LAA at this stage), as... Figure 15H As shown.

[0240] Deformable end bracket

[0241] Figure 16A , Figure 16B , Figure 16C , Figure 16D , Figure 16E and Figure 16F An example of an end-deformable stent 1640 is illustrated, configured for implantation in the atrial artery (LAA) to enhance atrial compliance. The end-deformable stent 1640 includes a distal portion adapted to pulsate between a concave and convex configurations. The end-deformable stent 1640 includes a frame 1642 extending between a proximal and distal end along a length adapted to provide a desired seal against the wall of the LAA. The end-deformable stent 1640 also includes a movable distal end portion 1646 consisting of a plurality of arched struts that extend radially inward and to a certain extent in an axial direction. A cap 1644 is disposed around the frame 1642 to seal the LAA wall and is disposed on the distal arcuate radial struts of the movable distal end portion 1646 to serve as a distal septum for closure at the distal end of the end-deformable stent 1640.

[0242] In some embodiments, the body of the end deformable support 1640 may be generally cylindrical to improve the seal with the surrounding LAA anatomy. The distal arcuate radial strut of the movable distal end portion 1646 is configured to move between convex and concave configurations in response to increases and decreases in blood pressure. For example, Figure 16E An example is an end deformable support 1640 in a convex configuration, and Figure 16F An example is an end deformable stent 1640 in a concave configuration. This configuration change alters the volume of the end deformable stent 1640 to enhance atrial compliance.

[0243] In some embodiments, blood can be drained from the LAA portion enclosed between the distal end of the end deformable stent 1640 and the LAA using a suitable aspiration device. For example, a guiding catheter can be advanced and terminated in the distal portion of the LAA 16. The end deformable stent 1640 can be deployed within the LAA 16 and can be retracted after blood aspiration. In some embodiments, the catheter can aspirate blood through the center of the end deformable stent 1640. This can be achieved by allowing the aspiration catheter to extend through a central opening formed at the distal end of the end deformable stent 1640 (such as one that can be used to aspirate blood through the center of the end deformable stent 1640). Figure 16C This is achieved through various means, including the central ring 1645 (as seen in the diagram). The suction catheter is configured to release and retract from the end deformable support 1640, such that the opening at the central ring 1645 can be closed to seal the distal end after the suction catheter is released. For example, the suction catheter may be threaded at the central ring 1645, and the flaps may be configured to close above the distal opening once the catheter is released and removed. In some embodiments, the catheter may extend through a one-way valve configured to prevent backflow in the proximal direction after removal.

[0244] Accessory wedge

[0245] Figure 17A and Figure 17B An appendage wedge 1740 configured for implantation in an LAA 16 is illustrated. The appendage wedge 1740 includes a proximal opening defined by a cap 1742 formed by a wire spring 1744 that presses outwards onto the cap 1742. The appendage wedge 1740 also includes an anchoring barb 1746 configured to secure the appendage wedge 1740 to the LAA. During diastole, the opening is flattened into a narrow opening due to reduced pressure on the cap 1742, which allows the wire spring 1744 to press outwards onto the cap 1742. During contraction, the opening opens wider due to increased pressure on the inwardly pressing wire spring 1744, thus widening the shape of the opening.

[0246] The wire spring 1744 presses outward along its two edges, causing the appendage wedge 1740 to flatten under diastolic pressure. Anchoring barbs 1746 at the apex of the wedge can be used to anchor the appendage wedge 1740 to the tissue. As pressure in the LA increases, the wedge inflates, thereby increasing its internal volume. Energy is stored in the spring wire as pressure increases from diastole to systole. This energy is returned as pressure decreases from systole to diastole. The volume change of the appendage wedge 1740 increases atrial compliance during the cardiac cycle. The inflow and outflow of blood during each cardiac cycle reduces or minimizes thrombus formation.

[0247] The accessory wedge 1740 can be coiled and delivered to the LAA 16 using a delivery catheter 1710. The delivery catheter 1710 may be configured to have a length sufficient to advance the accessory wedge 1740 through the patient's vascular system, into the right atrium, and across the interatrial septum to reach the LAA 16.

[0248] C-clamp

[0249] Figure 18 An internal compliance assist device 1840 is illustrated, which is configured to store energy during peak left atrial pressure and compress during low pressure. Device 1840 includes a C-clamp implanted in a left atrial artery (LAA) 16. During high pressure, the C-clamp of device 1840 is compressed to open the opening of the LAA 16. During low pressure, the C-clamp of device 1840 presses outward on the LAA 16 to flatten the opening of the LAA 16.

[0250] Magnetic extrusion

[0251] Figure 19A , Figure 19B , Figure 19C , Figure 19D and Figure 19E An example is illustrated of a magnetic device 1940 configured to enhance left atrial compliance by pressing the walls of an LAA 16. The magnetic device 1940 includes a pair of magnets 1942 attached to the walls of the LAA 16, wherein the polarities of the magnets 1942 are oriented such that they are attracted to each other. It should be noted that, depending on the implant configuration, magnets oriented in polarity to repel each other may also be considered. The magnets 1942 may include soft / flexible magnetic sheets (not shown) that can be secured to opposite sides of the LAA implant.

[0252] Figures 19A to 19C An example of the implantation of a magnetic device in 1940 is shown. Figure 19AIn this process, access to LAA 16 is achieved using a transseptal method with a delivery catheter 1910, wherein a balloon 1912 with a pair of magnets 1942 is deployed. Figure 19B In this process, a delivery catheter 1910 is used to inflate a balloon 1912 to attach a pair of magnets 1942 to the upper and lower surfaces of the LAA 16. Figure 19C In the middle, balloon 1912 deflates and delivery catheter 1910 retracts.

[0253] Figure 19D An example is shown of a magnetic device 1940 during atrial diastole, in which pressure forces a pair of magnets 1942 apart. Figure 19E An example of a magnetic device 1940 during atrial contraction is illustrated, wherein a decrease in pressure allows a pair of magnets 1942 to approach each other. This interaction with contraction and relaxation pushes and pulls the walls of the LAA 16 to promote blood flushing and enhance atrial compliance. That is, increased pressure causes the pair of magnets 1942 to separate, thereby allowing the LAA 16 to fill with blood. During atrial contraction, the pressure decreases and the pair of magnets 1942 closes again and helps eject blood from the LAA 16. In some embodiments, a stent is also placed in the LAA to enhance support for the pair of magnets 1942.

[0254] external spring

[0255] Figure 20A , Figure 20B and Figure 20C Another example device 2040 configured to enhance atrial compliance is illustrated. Device 2040 includes a first stent 2042 configured for implantation in a pulmonary vein and a second stent 2044 to be implanted in the left atrium. A spring 2046 is attached to the first stent 2042 and the second stent 2044. The spring 2046 is adapted to stretch and contract according to pressure during the cardiac cycle to enhance the filling and ejection of blood in the LA, such as... Figure 20A and Figure 20B As shown.

[0256] In some embodiments, the device 2040 is configured to be implanted in the LAA 16 together with the first stent 2042. In such embodiments, a spring 2046 may connect the first stent 2042 to an anchor or other element 2045 attached to the left atrial wall opposite the LAA 16. Similarly, the spring 2046 is adapted to stretch and contract according to pressure during the cardiac cycle to enhance the filling and ejection of blood into the left atrium. In some embodiments, the first stent 2042 is an occluder.

[0257] In-plane flexed membrane

[0258] Figure 21A , Figure 21B , Figure 21C and Figure 21D An example is illustrated of a device 2140 configured to provide in-plane deflection using a membrane 2142. The membrane 2142 is flexible at its periphery surrounding the orifice, thus allowing it to deflect in-plane with the LAA orifice during the cardiac cycle (and without fixing the tissue around the orifice). Therefore, the membrane 2142 deflects outward / in-plane with the LAA orifice.

[0259] Membrane 2142 is similar to a drumhead or elastic sheet, with nothing behind it. Therefore, membrane 2142 is constructed to resemble a stretchable atrial wall in two dimensions (e.g., along the surface area rather than perpendicular to it). Membrane 2142 can be attached to the orifice. In some embodiments, membrane 2142 functions as an occluder. In some embodiments, membrane 2142 does not deflect into or out of the LAA, but instead allows the orifice to open. This contrasts with typical occluder devices.

[0260] LAA closure with flushing mechanism

[0261] Figure 22A and Figure 22B An example embodiment of a LAA closure device 2240 with a flushing mechanism is illustrated. The LAA closure device 2240 is configured to reduce the risk of clot formation not by blocking the appendage but by increasing the flow rate to and from the appendage. Because the atrial appendage is not blocked, the LAA still acts as additional blood volume in the left atrium during systole and diastole, thereby increasing cardiac compliance.

[0262] The LAA closure device 2240 is implanted in a manner similar to typical LAA occlusion procedures and minimally invasive transcatheter procedures. The LAA closure device 2240 includes an expandable cylindrical frame 2242 on its circumference, surrounded by a sealing cloth 2244. An opening leading to an internal volume reservoir is present at the proximal edge. A second sealing cloth 2246 is present at the distal edge (as in a typical LAA occluder). The internal volume of the device can be altered, which is achieved using sails 2248 that function like a duckbill valve. During contraction, the sails 2248 move closer together, flushing blood from the internal volume. During diastole, the sails 2248 move away from each other, filling the internal volume with blood. The LAA closure device 2240 moves the occlusion plane deeper into the LAA, which is typically narrower and more difficult to flush. The sails 2248 are secured at the distal and proximal planes of the LAA closure device 2240. The intermediate material is configured to move and change shape.

[0263] In some embodiments, the LAA closure device 2240 is cylindrical, fabric-sealed, and has a self-expanding frame. The LAA closure device 2240 includes a proximal surface, a distal surface, and a sail 2248 between them. The sealing fabric 2244 provides the closure area. During diastole, the sail 2248 opens, and during contraction, the sail 2248 closes.

[0264] Figure 23A , Figure 23B , Figure 23C , Figure 23D , Figure 23E and Figure 23F Another example embodiment of the LAA closure device 2340 with a flushing mechanism is illustrated. Similar to having... Figure 22A and Figure 22B In one embodiment of the sail section, the LAA closure device 2340 includes a self-expanding cylindrical frame 2342 on its circumference. It is surrounded by a sealing cloth 2343. An opening leading to an internal volume reservoir is present on the proximal edge. Within the internal volume of the LAA closure device 2340, there is a set of flexible membranes 2346 that can change their geometry due to pressure changes during the cardiac cycle. The membranes 2346 are concave during systole and convex during diastole, as... Figure 23B and Figure 23C As shown. The change in the geometry of membrane 2346 improves blood flow within the LAA closure device 2340. Membrane 2346 can be coupled to a support rod 2344 extending from the proximal edge of the cylindrical frame 2342.

[0265] LAA closure device 2340 is configured to maintain additional blood volume in the LAA and provide a flushing mechanism to prevent thrombosis. LAA closure device 2340 moves the obstruction plane deeper into the LAA, which is typically narrower and more difficult to flush. LAA closure device 2340 includes a cylindrical, cloth-sealed, self-expanding frame with multiple flexible membranes inside. Figure 23E and Figure 23F An exemplary membrane 2346 is illustrated. Membrane 2346 may be a nitinol shaped yarn encapsulated with ePTFE, an ePTFE membrane, and / or an ePTFE-encapsulated nitinol braid.

[0266] Additional features and implementation schemes

[0267] This disclosure provides methods and apparatus (including various medical implants) for addressing elevated left-sided filling pressure to mitigate the effects of diastolic dysfunction. The term "implant" is used herein in its ordinary and / or common sense and can refer to any medical implant, frame, valve, shunt, stent, anchor, and / or similar device used to treat a variety of conditions in the human body. Implants can be delivered via catheter (i.e., transcatheter) for a variety of medical procedures and can have a generally robust and / or flexible structure. The term "catheter" is used herein in its broad and / or common sense and can include any tube, sheath, steerable sheath, steerable catheter, and / or any other type of elongated tubular delivery device comprising an endometrium configured to slidably receive an instrument, such as for positioning within the atrium or appendages, including, for example, delivery catheters and / or cannulas. Some of the transcatheter procedures described herein can utilize a single catheter or multiple catheters.

[0268] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the resulting claims is not limited to any particular embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple discrete operations in a manner conducive to understanding certain embodiments; however, the order of description should not be construed as implying that these operations are sequentially related. Additionally, the structures, systems, and / or apparatuses described herein may be implemented as integrated components or separate components. For comparison of the various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one or a set of advantages taught herein, without necessarily achieving other aspects or advantages also taught or suggested herein.

[0269] The term “associated with” is used herein in its broad and general sense. For example, when 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 to indicate that the first feature, element, component, device, or member is physically connected, attached, integrated, at least partially embedded therein, or otherwise physically related to the second feature, element, component, device, or member, directly or indirectly.

[0270] The above description of embodiments of this disclosure is not intended to be exhaustive of all embodiments, nor is it intended to limit this disclosure to the precise form disclosed above. While specific embodiments and examples have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of this disclosure. For example, although processes or blocks are presented in a given order, alternative embodiments may execute routines with steps or employ systems with 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 various different ways. Furthermore, although processes or blocks are sometimes shown as being executed sequentially, these processes or blocks may alternatively be executed in parallel or may be executed at different times.

[0271] This document uses certain positional terms regarding various disclosed embodiments. While this document uses certain spatially relative terms, such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms to describe the spatial relationship of one device / element or anatomical structure relative to another device / element or anatomical structure, it should be understood that, for ease of description, these terms are used herein to describe the positional relationship between elements / structures, as illustrated in the figures. In addition to the orientations depicted in the figures, spatially relative terms are intended to encompass different orientations of elements / structures in use or operation. For example, an element / structure described as “above” another element / structure may indicate a position relative to the patient being tested or an alternative orientation of the element / structure below or beside such other element / structure, and vice versa.

[0272] The conditional language used herein, such as “can,” “able,” “may,” “possibly,” “for example,” etc., unless explicitly stated otherwise or understood as used in the context, generally expresses that some embodiments include certain features, elements, and / or components, while other embodiments do not include certain features, elements, and / or steps. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are necessary in any of the embodiments, or that one or more embodiments must, with or without user input or prompts, include logic for determining whether such features, elements, and / or steps are included in or will be performed in any particular embodiment.

[0273] 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 order. Therefore, as used herein, ordinal terms used to modify elements (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate the priority or order of said element relative to any other element, but can generally distinguish said element from another element with a similar or identical name (but using ordinal terms). Additionally, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one”. Furthermore, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly stated. In some contexts, describing an operation or event as “based on” or “at least partially based on” the occurrence or execution of the stated event or condition can be interpreted as being triggered by or in response to the stated event or condition.

[0274] Regarding the various methods and processes disclosed herein, although a certain order of operations or steps is shown and / or described, it should be understood that the various steps and operations shown and described can be performed in any suitable or desired chronological order. Furthermore, any operation or step shown and / or described may be omitted from any given method or process, and the methods and processes shown / described may include additional operations or steps not explicitly shown or described.

[0275] It should be understood that in the above description of the embodiments, various features are sometimes combined in a single embodiment, drawing, or description thereof for the purpose of simplifying this disclosure and aiding in the understanding of one or more aspects of the invention. However, this approach of the disclosure should not be construed as reflecting an intention in any claim to require more features than those expressly recited in the claim. Furthermore, any component, feature, or step illustrated and / or described in the specific embodiments herein may be applied to or used with any other embodiment. Moreover, for each embodiment, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of the invention disclosed herein and claimed below should not be limited to the specific embodiments described above, but should be determined solely by a careful reading of the appended claims.

[0276] Unless the context explicitly requires otherwise, throughout the description and claims, the terms “comprise / comprising,” “have / having,” “include / including,” etc., should be interpreted in an open and inclusive sense, rather than in a closed, exclusive, or exhaustive sense; that is, in the sense of “including but not limited to.”

[0277] As commonly used herein, the term "connection" means two or more elements that can be physically, mechanically, and / or electrically connected or otherwise associated, directly or indirectly (e.g., via one or more intermediary elements, components, and / or devices). Additionally, when used herein, the terms "in this document," "above," "below," and similar introductory terms should refer to the entire application, including any disclosure incorporated by reference, but not any specific portion of this disclosure. Where the context permits, singular or plural terms used in this disclosure may also include the plural or singular, respectively.

[0278] When the word "or" refers to a list of two or more items, it encompasses all of the following interpretations: any item in the list, all items in the list, and any combination of items in the list. Furthermore, as used herein, the term "and / or" used between elements (e.g., between the last two in a list of elements) means any one or more of the mentioned / 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".

[0279] As may be used herein, the terms “substantially” and “approximately” provide industry-accepted tolerances for the correlation between their corresponding terms and / or items. For some industries, industry-accepted tolerances are less than one percent, while for others they can be 10% or higher. Other examples of industry-accepted tolerance ranges from less than one percent to fifty percent. Industry-accepted tolerances correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise and fall times, thermal noise, dimensions, transmission errors, dropped packets, temperature, pressure, material composition, and / or performance metrics. Within an industry, tolerance variations in acceptable tolerances can be greater than or less than a certain percentage level (e.g., a size tolerance of less than approximately + / - 1%). A certain relativity between items can range from a difference of less than one percentage level to several percentages. Other relativity between items can range from a difference of several percentages to a large difference.

[0280] One or more embodiments have been described above by way of illustrating the execution of specified functions and their relationships. For ease of description, the boundaries and order of these functional building blocks and method steps have been arbitrarily defined herein. Alternative boundaries and sequences can be defined as long as the specified functions and relationships are properly performed. Therefore, any such alternative boundaries or sequences are within the scope and spirit of the claims. Furthermore, for ease of description, the boundaries of these functional building blocks have been arbitrarily defined. Alternative boundaries can be defined as long as certain important functions are properly performed. Similarly, flowchart blocks can also be arbitrarily defined herein to illustrate certain important functionalities.

[0281] Within the scope of use, flowchart block boundaries and sequences can be defined in other ways and still perform certain important functionalities. Therefore, this alternative definition of functional building blocks and flowchart blocks and sequences is within the scope and spirit of the claims. Those skilled in the art will also recognize that the functional building blocks and other illustrative blocks, modules, and components described herein can be implemented as shown or by discrete components, application-specific integrated circuits, processors executing appropriate software, or any combination thereof.

[0282] One or more embodiments are used herein to illustrate one or more aspects, features, concepts, and / or examples. Physical embodiments of equipment, articles of manufacture, machines, and / or processes may include one or more of the aspects, features, concepts, examples, etc., described with reference to one or more embodiments discussed herein. Furthermore, from figure to figure, embodiments may incorporate functions, steps, modules, etc., with the same or similar names that may be used with the same, related, or unrelated reference numerals. Related features, elements, functions, operations, modules, etc., may be the same or similar functions or may be unrelated.

Claims

1. An implant suitable for deployment in the left atrial appendage, the implant comprising: Proximal frame portion; The distal frame portion; and A cap, extending along the proximal frame portion and the distal frame portion, provides a seal at the distal end of the distal frame portion to prevent blood from penetrating 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 contract during atrial diastole to enhance left atrial compliance and thereby improve cardiac function.

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

3. The implant of claim 1, wherein the distal frame portion has an elliptical cross-section in the contracted state.

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

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

6. The implant of claim 1, wherein the seal is flexible to enhance left atrial compliance during atrial contraction.

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

8. The implant of claim 1, wherein the cap connects 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 of nitinol.

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

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

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

13. The implant of claim 1, wherein the cap is made of polyester.

14. The implant of claim 1, wherein the implant is foldable for insertion into the left atrial appendage via catheter insertion technique.

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

16. An end-cap deformable stent suitable for implantation in a patient's left atrial appendage (LAA) to enhance atrial compliance, said end-cap deformable stent comprising: A frame that extends between a proximal end and a distal end; and The movable distal end portion includes a plurality of pillars that are arched and extend radially inward and axially. The movable distal end portion is configured to pulsate between a convex configuration and a concave configuration in response to changes in left atrial pressure.

17. The end deformable bracket of claim 16, further comprising a cover disposed around the frame and the movable distal end portion.

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

19. The end deformable bracket of claim 16, wherein the frame is cylindrical to enhance the seal with the LAA.

20. The end deformable support 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 the delivery catheter is adapted to be coupled to the central ring to enable blood aspiration from the LAA during 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 the delivery catheter is removed.

23. The end deformable support of claim 22, wherein the central ring includes a flap configured to close the central ring after removal of the delivery conduit.

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

25. A left atrial appendage (LAA) implant, said LAA implant being configured to enhance atrial compliance, said LAA implant comprising: Compliant membrane; and An annular frame portion, which is connected to the compliant membrane, is configured to anchor at the opening of the patient's LAA. The compliance membrane is configured to provide pressure-mediated radial expansion during atrial filling. The compliant membrane is configured to help eject blood from the LAA into the left atrium during left atrial contraction.

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

27. The LAA implant of claim 26, wherein the compliant membrane is configured to return to the orifice after bulging inward into the LAA in response to low left atrial pressure to aid in the ejection of blood from the LAA.

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

29. The LAA implant of claim 25, wherein the annular frame portion includes anchoring features for securely anchoring to the opening 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 being coupled to the annular frame portion to form a cavity, the compliant membrane being configured to extend into the cavity.

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