Addressing elevated left-sided filling pressures

Abstract

Disclosed herein are technologies for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. Embodiments provide ways to decrease the temporal increase in blood flow and pressure into the heart from the venous system. Under exertion, there is a shift of blood from the 'unstressed' reservoir of vasculature, which primarily comprises the splanchnic system, to the 'stressed' reservoir, which comprises the heart and lungs. By inhibiting this acute shifting of blood from the 'unstressed' reservoir to the 'stressed' reservoir, an undesirable influx of blood volume to the already overloaded left heart can be avoided. Certain embodiments provide ways to increase atrial elasticity, or atrial compliance. This enhancement of atrial compliance enables the atrium to 'absorb' the energy of short bursts of high left atrial pressure. Consequences are a reduction in the retrograde flow in the pulmonary veins to inhibit acute pulmonary congestion.

Description

ADDRESSING ELEVATED LEFT-SIDED FILLING PRESSURESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 562,640, filed on March 7, 2024, the complete disclosure of which is hereby incorporated by reference in its entirety.BACKGROUNDField

[0002] The present disclosure relates to devices and methods that address elevated leftsided filling pressures in the heart.Description of the Related Art

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

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

[0005] Described herein are methods and / or devices that provide a variety of ways to inhibit or prevent backward propagation of elevated pressures from the left heart to the pulmonary vasculature. The methods and / or devices are configured to reduce blood flow into the heart and lungs.

[0006] Described herein are methods and / or devices that provide a variety of ways to inhibit or prevent backward propagation of elevated pressures from the left heart to the pulmonaryvasculature. The methods and / or devices are configured to enhance atrial compliance to handle temporal increases in left atrial pressure.

[0007] In some implementations, a portal vein choke device configured to reduce blood flow to the heart is provided. The portal vein choke device includes a first anchor configured to be anchored to an exterior wall of a portal vein; a second anchor configured to be anchored to an interior wall of an inferior vena cava; and a tether having a distal end secured to the first anchor and a proximal end secured to the second anchor, the tether configured to pass through the interior wall of the inferior cava and through the portal vein to pull the first anchor toward the second anchor to effectively reduce a cross-sectional lumen size of the portal vein, thereby reducing blood flow through the portal vein.

[0008] In some implementations, the first anchor and the second anchor are pledgets. In some implementations, the portal vein choke device further includes a first bulb at the distal end of the tether, the first bulb configured to secure the tether to the first anchor; and a second bulb at the proximal end of the tether, the second bulb configured to secure the tether to the second anchor. In some implementations, the tether comprises a suture and the first bulb comprises one or more knots in the suture at the distal end of the tether and the second bulb comprises one or more knots in the suture at the proximal end of the tether.

[0009] In some implementations, a portal vein choke system configured to reduce blood flow to the heart is provided. The portal vein choke system includes a first portal vein choke device comprising a first anchor configured to be anchored to an exterior wall of a portal vein; a second anchor configured to be anchored to an interior wall of an inferior vena cava; and a first conduit having a distal end secured to the first anchor and a proximal end secured to the second anchor, the first conduit configured to pass through the interior wall of the inferior cava and through the portal vein to pull the first anchor toward the second anchor to effectively reduce a cross-sectional lumen size of the portal vein, thereby reducing blood flow through the portal vein; and a second portal vein choke device comprising a third anchor configured to be anchored to the exterior wall of the portal vein; a fourth anchor configured to be anchored to the interior wall of the inferior vena cava; and a second conduit having a distal end secured to the third anchor and a proximal end secured to the fourth anchor, the second conduit configured to pass through the interior wall of the inferior cava and through the portal vein to pull the third anchor toward the fourth anchor to effectively reduce a cross-sectional lumen size of the portal vein at a location upstream of the first portal vein choke device.

[0010] In some implementations, the first portal vein choke device further comprises a temperature sensor coupled to the first conduit. In some implementations, the second conduit of the second portal vein choke device forms an injection port configured to inject liquid into the portalvein. In some implementations, a flow rate through the portal vein is determined based at least in part on a temperature of blood and injected liquid measured with the temperature sensor of the first portal vein choke device, the injected liquid provided through the injection port of the second portal vein choke device.

[0011] In some implementations, a method of implanting a portal vein choke device that is configured to reduce blood flow to the heart is provided. The method includes using a delivery device, delivering the portal vein choke device through the inferior vena cava to a point where the inferior vena cava and a portal vein are approximately parallel; puncturing through an interior wall of the inferior vena cava and through the portal vein to access an exterior wall of the portal vein; deploying a first anchor on the exterior wall of the portal vein; deploying a tether by securing a distal end of the tether to the first anchor; deploying a second anchor on the interior wall of the inferior vena cava; providing a targeted tension to the tether to approximate the first anchor to the second anchor to effectively reduce a cross-sectional lumen size of the portal vein; and securing a proximal end of the tether to the second anchor in the tensioned state to maintain force on the portal vein, thereby reducing blood flow through the portal vein.[00121 In some implementations, the first anchor and the second anchor are pledgets. In some implementations, the method further includes using a delivery device, delivering a second portal vein choke device through the inferior vena cava to a point upstream of the portal vein choke device; puncturing through the interior wall of the inferior vena cava and through the portal vein to access the exterior wall of the portal vein in a position upstream of the portal vein choke device; deploying a third anchor on the exterior wall of the portal vein; deploying a second conduit by securing a distal end of the second conduit to the third anchor; deploying a fourth anchor on the interior wall of the inferior vena cava; providing a targeted force on the second conduit to approximate the third anchor to the fourth anchor to effectively reduce a cross-sectional lumen size of the portal vein at a second location relative to the portal vein choke device; and securing a proximal end of the second conduit to the fourth anchor to maintain force on the portal vein, thereby reducing blood flow through the portal vein. The tether includes a first conduit.

[0013] In some implementations, the method further includes injecting fluid through an injection port of the second conduit of the second portal vein choke device into the portal vein. In some implementations, the method further includes measuring a temperature of blood and the injected fluid with a temperature sensor that is coupled to the first conduit of the portal vein choke device. In some implementations, the method further includes determining a flow rate through the portal vein based on the measured temperature. In some implementations, the method further includes adjusting the fourth anchor to adjust a flow rate through the portal vein.

[0014] In some implementations, a portal vein choke device configured to reduce blood flow to the heart is provided. The device includes a first anchor configured to be anchored to an exterior wall of a portal vein; a second anchor configured to be anchored to an interior wall of an inferior vena cava; a conduit comprising a pliable membrane at a proximal end and a port at a distal end, the conduit having the distal end secured to the first anchor and the proximal end secured to the second anchor, the conduit forming an open end at the distal end that is covered by the pliable membrane, the conduit configured to pass through the interior wall of the inferior cava and through the portal vein so that the pliable membrane is exposed to blood flowing within the inferior vena cava and the port is positioned external to the portal vein; and a balloon coupled to the conduit at the distal end of the conduit so that the balloon is in fluidic communication with the conduit through the port, the balloon configured to be positioned between the first anchor and the exterior wall of the portal vein when implanted, wherein the conduit and the balloon form a sealed system that is filled with a fluid, wherein the sealed system is configured so that responsive to blood pressure in the inferior vena cava exceeding blood pressure in the portal vein the pliable membrane of the conduit extends within the conduit to push the fluid into the balloon to inflate the balloon, wherein the sealed system is configured so that responsive to blood pressure in the inferior vena cava being similar to blood pressure in the portal vein the pliable membrane is approximately flat with the proximal end of the conduit resulting in deflation of the balloon by pushing the fluid back into the conduit through the port, and wherein inflation of the balloon is directed along the exterior wall of the portal vein by the first anchor to effectively reduce a cross-sectional lumen size of the portal vein, thereby reducing blood flow through the portal vein.

[0015] In some implementations, the first anchor and the second anchor are configured to be self-deploying. In some implementations, the first anchor and the second anchor comprise a shape memory alloy. In some implementations, the fluid comprises a saline solution. In some implementations, the pliable membrane comprises a baffle.

[0016] In some implementations, a device for enhancing atrial compliance is provided. The device includes an anchor structure adapted to be anchored in the interatrial septum between the left atrium and the right atrium; and a deformable membrane coupled to the anchor structure. In some implementations, the anchor structure comprises an annular seal adapted to be anchored within a hole in the interatrial septum between the left atrium and the right atrium. In some implementations, the deformable membrane comprises an inner compliant membrane coupled to the annular seal to seal the hole in the interatrial septum.

[0017] In some implementations, a device for enhancing atrial compliance is provided. The device includes an anchor structure adapted to be anchored in the interatrial septum between the left atrium and the right atrium; and a deformable membrane coupled to the anchor structure. Insome implementations, the anchor structure comprises a frame adapted to anchor to the interatrial septum. In some implementations, the deformable membrane comprises a deformable diaphragm coupled to the frame, the deformable diaphragm adapted to fill and to empty responsive to pressures in the right atrium.

[0018] In some implementations, a bulging membrane configured to be implanted in the interatrial septum to enhance atrial compliance is provided. The bulging membrane includes an annular seal configured to be anchored within a hole in the interatrial septum between the left atrium and the right atrium; and an inner compliant membrane coupled to the annular seal to seal the hole in the interatrial septum, wherein the bulging membrane is configured to respond to a threshold pressure such that responsive to pressure in the left atrium exceeding the threshold pressure, the inner compliant membrane is configured to deform into the right atrium to increase effective volume in the left atrium to enhance atrial compliance, and wherein responsive to pressure in the left atrium being at or below the threshold pressure, the inner compliant membrane is configured to be flush with the interatrial septum.

[0019] In some implementations, the threshold pressure is about 25 mmHg. In some implementations, the inner compliant membrane is configured to be stiff in one direction and compliant in another direction so that the inner compliant membrane is configured to bulge into the right atrium and to not bulge into the left atrium. In some implementations, the inner compliant membrane is configured to be compliant in both directions so that the membrane is adapted to bulge into the right atrium and into the left atrium.

[0020] In some implementations, a right atrium reservoir device includes a frame configured to anchor to the interatrial septum; and a deformable diaphragm coupled to the frame, the deformable diaphragm configured to fill and to empty responsive to pressures in the right atrium, wherein the deformable diaphragm is configured to fill with deoxygenated blood from the right atrium responsive to a pressure gradient between right atrial pressure and left atrial pressure exceeding a threshold value.

[0021] In some implementations, the threshold value is 10 mmHg. In some implementations, the threshold value is between 8 mmHg and 12 mmHg. In some implementations, the deformable diaphragm is configured to empty to become flush with the septum responsive to the pressure gradient being less than the threshold value. In some implementations, the deformable diaphragm is configured to bulge into the left atrium responsive to the pressure gradient exceeding the threshold value. In some implementations, the deformable diaphragm is configured to bulge into the right atrium responsive to the pressure gradient being less than the threshold value. In some implementations, the deformable diaphragm is configured to bulge into a space outside of the heart.In some implementations, the frame comprises a stent with anchors that extend into the right atrium to secure the frame to the septum.

[0022] In some implementations, a method for implanting a pressure balloon syringe is provided. The method includes delivering the pressure balloon syringe to the left atrium via delivery from the right atrium to the left atrium through the septum using a delivery device comprising a delivery device conduit; deploying the pressure balloon syringe through the septum into the left atrium, the pressure balloon syringe comprising a housing forming a tail portion coupled to the delivery device conduit and a nose portion forming an opening in the nose portion, a piston within the housing between the tail portion and the nose portion, and a balloon in fluidic communication with the tail portion; rotating the pressure balloon syringe approximately 90 degrees so that the tail portion and the nose portion of the housing are configured to be approximately parallel to a wall of the septum; withdrawing the delivery device conduit to pull the pressure balloon syringe to be flush with the wall of the septum; inflating the balloon via the tail portion of the housing using the delivery device conduit to deliver fluid to the balloon, the balloon and tail portion being filled to a target pressure; anchoring the pressure balloon syringe to the wall of the septum; and decoupling the delivery device from the pressure balloon syringe, wherein the piston is configured to provide a seal between the tail portion and the nose portion, wherein, responsive to a pressure in the left atrium exceeding a target threshold, the balloon is configured to push the fluid into the tail portion causing the piston to move toward the nose portion expelling blood through the opening formed in the nose portion, and wherein, responsive to the pressure in the left atrium being less than the target threshold, the nose portion is configured to fill with blood causing the piston to move toward the tail portion pushing fluid into the balloon to inflate the balloon.

[0023] In some implementations, the target threshold is about 25 mmHg. In some implementations, the target pressure is about 15 mmHg.

[0024] In some implementations, a left atrial balloon pump is provide that includes a reservoir filled with a fluid; a catheter extending over a guidewire between the reservoir and the left atrium, the catheter providing in fluidic communication with the reservoir, the catheter comprising a central lumen for the guidewire and a second lumen; and a balloon positioned within the left atrium, coupled to the catheter via a transseptal puncture through the interatrial septum, the balloon in fluidic communication with the reservoir via the catheter to allow fluid exchange between the balloon and the reservoir through the second lumen of the catheter, wherein movement of fluid between the balloon and the reservoir is regulated by an internal pressure of the fluid in the reservoir and cavity pressure in the left atrium, wherein, during ventricular systole the balloon is configured to be deflated and during ventricular diastole the balloon is configured to be inflated.

[0025] In some implementations, the reservoir comprises an extravascular reservoir. In some implementations, the extravascular reservoir is placed in the thoracic cavity. In some implementations, the extravascular reservoir is placed in subcutaneous space.

[0026] In some implementations, the left atrial balloon pump further includes a two-way pressure regulated valve configured to provide control on fluid movement between the balloon and the reservoir. In some implementations, the balloon is configured to deflate responsive to the left atrial pressure exceeding the internal pressure of the fluid in the reservoir. In some implementations, the balloon is configured to inflate responsive to the left atrial pressure being less than the internal pressure of the fluid in the reservoir.

[0027] In some implementations, a balloon pump system configured to enhance atrial compliance is provided. The balloon pump system includes a reservoir filled with a fluid; a multilumen catheter extending over a guidewire between the reservoir and the left atrium, the catheter in fluidic communication with the reservoir, the catheter comprising a first lumen for the guidewire, a second lumen, and a third lumen; a first balloon positioned within the left atrium, coupled to the catheter via a transseptal puncture through the interatrial septum, the first balloon in fluidic communication with the reservoir via the second lumen to allow fluid exchange between the first balloon and the reservoir; and a second balloon positioned within a vessel outside of the heart, coupled to the catheter, the second balloon in fluidic communication with the reservoir via the third lumen to allow fluid exchange between the second balloon and the reservoir, the second balloon sized such that the second balloon is configured to occlude the vessel in which the second balloon is positioned when inflated; wherein movement of fluid between the first balloon, the second balloon, and the reservoir is regulated by an internal pressure of the fluid in the reservoir and atrial pressure in the left atrium, wherein, during ventricular systole, the first balloon is configured to be deflated sending fluid to the second balloon to inflate the second balloon responsive to the atrial pressure exceeding a threshold value, and wherein, during ventricular diastole, the first balloon is configured to be inflated and the second balloon is configured to deflate responsive to the atrial pressure being below the threshold value.

[0028] In some implementations, the threshold value is about 15 mmHg. In some implementations, the second balloon is configured to be positioned in the inferior vena cava. In some implementations, the second balloon is configured to be positioned in a hepatic vein. In some implementations, the balloon pump system further includes a second reservoir in fluidic communication with the second balloon, the reservoir in fluidic communication with the first balloon. In some implementations, the balloon pump system further includes a check regulator between the first balloon and the second balloon.

[0029] In some implementations, a device configured for implantation in a left atrial appendage (LAA) of a patient to provide anti-stasis compliance to a heart of the patient is provided. The device includes an inlet valve; an outlet valve; and a partitioned compliant casing defining a flow path from the inlet valve to the outlet valve. The partitioned compliant casing is configured to provide a lumen into which blood can flow into and out of responsive to changes in pressure in a left atrium of the heart. The inlet valve provides for blood flow from the left atrium into the flow path, and the outlet valve provides for blood flow from the flow path back into the left atrium.

[0030] In some implementations, the flow path through the partitioned compliant casing with the inlet valve and the outlet valve is configured to reduce thrombus formation by providing a flow of blood through the flow path without creating regions of stasis. In some implementations, the inlet valve comprises a unidirectional valve. In some implementations, the outlet valve comprises a unidirectional valve. In some implementations, the partitioned compliant casing includes a partition defining a lumen through the device, the lumen forming the flow path from the inlet valve to the outlet valve. In some implementations, the device is configured to force blood flow in one direction through the lumen defined by the partition. In some implementations, the inlet valve is configured to open responsive to an increase in left atrial pressure. In some implementations, the outlet valve is configured to open responsive to a decrease in left atrial pressure below pressure in the flow path which in turn causes the inlet valve to close. In some implementations, responsive to the increase in left atrial pressure, the partitioned compliant casing increases in size to enhance atrial compliance.

[0031] In some implementations, a device configured for implantation in a puncture in a wall of a left atrium of a patient to provide anti-stasis compliance to a heart of the patient is provided. The device includes an inlet valve; an outlet valve; and a compliant tube defining a flow path between the inlet valve to the outlet valve. The compliant tube is configured to provide a lumen into which blood can flow into and out of responsive to changes in pressure in a left atrium of the heart. The inlet valve provides for blood flow from the left atrium into the flow path, and the outlet valve provides for blood flow from the flow path back into the left atrium.

[0032] In some implementations, the flow path through the compliant tube with the inlet valve and the outlet valve is configured to reduce thrombus formation by providing a flow of blood through the flow path without creating regions of stasis. In some implementations, the inlet valve comprises a unidirectional valve. In some implementations, the outlet valve comprises a unidirectional valve. In some implementations, the device is configured to force blood flow in one direction through the compliant tube. In some implementations, the inlet valve is configured to open responsive to an increase in left atrial pressure. In some implementations, the outlet valve is configured to open responsive to a decrease in left atrial pressure below pressure in the flow pathwhich in turn causes the inlet valve to close. In some implementations, responsive to the increase in left atrial pressure, the compliant tube increases in size to enhance atrial compliance. In some implementations, the compliant tube extends into pericardial space outside of the heart.

[0033] In some implementations, a vessel compliance device configured to be implanted in a vessel of a patient to increase compliance of the vessel is provide. The vessel compliance device includes a stent configured to be anchored to a wall of a vessel; a squeezable layer covering the stent and forming an inner lumen through the stent to provide a flow path for blood through the vessel compliance device, the squeezable layer configured to change size responsive to changes in blood pressure in the vessel. The squeezable layer changes between a squeezed state and an unsqueezed state. The squeezed state occurs where inner walls of the squeezable layer are pushed radially outwards under elevated blood pressure, thereby increasing a diameter of the inner lumen. The un-squeezed state occurs where the inner walls of the squeezable layer moving radially inwards responsive to a decrease in blood pressure from the elevated blood pressure, thereby decreasing the diameter of the inner lumen.

[0034] In some implementations, the vessel compliance device is configured to be anchored against an inner wall of a pulmonary vein close to a pulmonary ostium of a left atrium. In some implementations, the vessel compliance device increases an inner diameter of the inner wall of the pulmonary vein. In some implementations, the squeezable layer is filled with a gas. In some implementations, the squeezable layer is filled with a liquid.

[0035] In some implementations, the vessel compliance device further includes a tube coupled to the squeezable layer, the tube configured to convey fluid to and from the tube; and a container apart from the stent and coupled to the tube, wherein the squeezable layer contains a fluid that moves between the container and the squeezable layer responsive to changes in pressure in blood flowing through the inner lumen. In some implementations, the squeezable layer comprises a double-walled layer that contains the fluid. In some implementations, in the squeezed state, fluid is forced from the squeezable layer through the tube to the container. In some implementations, in the un-squeezed state, fluid flows from the container to the squeezable layer via the tube. In some implementations, fluid is forced out of the container in the un-squeezed state by pressure applied by the container. In some implementations, the container is configured to be implanted outside of the vessel within which the stent is anchored.

[0036] In some implementations, an atrial enhancement balloon device adapted to enhance atrial compliance in a left atrium of a heart of a patient is provided. The atrial enhancement balloon device includes a sealing structure adapted to hold open and seal a puncture through tissue, the puncture providing a blood flow path out of the left atrium and out of the heart; and a flexible membrane mounted to the sealing structure to receive blood through the puncture through thetissue, the flexible membrane adapted to receive blood from the left atrium and to expand and contract responsive to changes in pressure in the left atrium. Responsive to elevated pressure in the left atrium, blood flows through the sealing structure into the flexible membrane, thereby increasing a volume of the flexible membrane. Responsive to a decrease in pressure in the left atrium, the volume of the flexible membrane decreases and pushes blood through the sealing structure into the left atrium.[00371 In some implementations, the flexible membrane comprises a balloon. In some implementations, the flexible membrane extends into pericardial space. In some implementations, the flexible membrane is adapted to assume a flattened configuration to conform to a pericardial plane to fit under a pericardium of the heart. In some implementations, the sealing structure is adapted to hold open a puncture in a wall of the left atrium. In some implementations, the sealing structure is adapted to hold open a puncture in a wall of the left atrial appendage.

[0038] In some implementations, a method for implanting an atrial enhancement balloon device in a left atrial appendage of a patient is provide. The method includes advancing a transeptal catheter into a left atrium towards the left atrial appendage; implanting a sealing ring at an opening of the left atrial appendage; mounting a valve inside the sealing structure; applying suction to a distal wall of the left atrial appendage to draw the distal wall of the left atrial appendage towards the opening of the left atrial appendage; puncturing the distal wall of the left atrial appendage; and mounting a flexible membrane to the sealing structure so that the flexible membrane extends out of the puncture in the distal wall of the left atrial appendage away from the left atrium. Responsive to elevated pressure in the left atrium, blood flows through the sealing structure into the flexible membrane, thereby increasing a volume of the flexible membrane. Responsive to a decrease in pressure in the left atrium, the volume of the flexible membrane decreases and pushes blood through the sealing structure into the left atrium.

[0039] In some implementations, the valve is a unidirectional valve adapted to ensure that suction is limited to a volume of the left atrial appendage. In some implementations, the method further includes removing the valve after implantation of the flexible membrane. In some implementations, the flexible membrane comprises a balloon. In some implementations, an ablation catheter is used to puncture the distal wall of the left atrial appendage. In some implementations, the flexible membrane is configured to extend into pericardial space.

[0040] For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the disclosure. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0042] FIG. 1 illustrates an example portal vein choke that is configured to reduce blood flow to the heart.

[0043] FIGS. 2A, 2B, 2C, 2D, and 2E illustrate another example of a portal vein choke system that includes a lower portal vein choke and an upper portal vein choke.

[0044] FIG. 3 illustrates another example of a portal vein choke that acts as a selfregulating portal vein choke.

[0045] FIGS. 4A, 4B, and 4C illustrate a bulging membrane implanted in the septum between the left atrium and the right atrium of the heart.

[0046] FIGS. 5 A and 5B illustrate a right atrium reservoir that is configured to provide interatrial fluidic communication.

[0047] FIGS. 6A, 6B, 6C, 6D, 6E, 6F, and 6G illustrate an example of a pressure balloon syringe that is configured to be implanted in the septum between the left atrium and the right atrium.

[0048] FIGS. 7A and 7B illustrate an example of a left atrial balloon pump that includes a balloon that is in fluidic communication with an extravascular reservoir through a catheter.

[0049] FIG. 7C illustrates a trio of graphs that demonstrate an example or simulation of the effect of the left atrial balloon pump of FIGS. 7A and 7B.

[0050] FIGS. 8A, 8B, 8C, and 8D illustrate an example balloon pump system to enhance atrial compliance.

[0051] FIG. 9 illustrates a device configured for implantation in the left atrial appendage (LAA), the device designed to provide anti-stasis compliance bypass to the heart.

[0052] FIG. 10 illustrates a device with a compliant tube that is configured to provide antistasis compliance bypass to the heart.

[0053] FIG. 11 illustrates an example of an atrial enhancement balloon extending from the wall of the left atrium.

[0054] FIGS. 12A, 12B, 12C, and 12D illustrate example vessel compliance devices that are configured to add compliance to a section of a pulmonary vein or other vessel.

[0055] FIG. 13 illustrates an example of an atrial enhancement balloon extending from the LAA.

[0056] FIGS. 14A, 14B, 14C, and 14D illustrate stages of a method of puncturing the LAA and mounting the atrial enhancement balloon device of FIG. 13.DETAILED DESCRIPTION

[0057] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter.Overview

[0058] Diastolic dysfunction is a heart condition that happens when there is a “stiffening” of the major pumping chambers of the organ (ventricles). This stiffness impedes the heart’s ability to fill up with blood between heartbeats. Consequently, the heart does not fill up with as much blood as it should and / or the heart pumps out less blood to the rest of the body relative to a healthy heart.

[0059] Diastolic dysfunction of the heart is characterized by high left-sided filling pressures of the left ventricle. In addition, the left atrium has elevated pressures as measured by elevated post capillary wedge pressure (PCWP) both at rest and under exertion. As the left atrial pressure increases, the walls of the left atrium dilate and stretch to a less materially compliant state. In other words, there is a loss of elasticity in the myocardium of the dilated left atrium to absorb temporal increases in left atrial pressure. The net effect is a back-up of flow from the left atrium into the pulmonary veins and subsequently into the capillary bed of the lung parenchyma. This increased pressure in the pulmonary vasculature causes an elution of water into the alveoli of the lungs which is felt as pulmonary congestion and shortness of breath by the patient. Unchecked, diastolic dysfunction can progress to diastolic heart failure.

[0060] Thus, there is a need to add compliance to the left atrium to inhibit or prevent backwards pressure transmission from the left heart to the pulmonary vasculature, which may be particularly advantageous for patients with atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). Accordingly, disclosed herein are devices and methods for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. Various embodiments provide ways to decrease the temporal increase in blood flow and pressure into the heart from the venous system (which drains from the body). Under exertion, there is a shift of blood from the ‘unstressed’ reservoir of vasculature, which primarily comprises the splanchnic system (e.g., liver, spleen, gut), to the ‘stressed’ reservoir, which comprises the heart and lungs. By inhibiting or preventing this acute shifting of blood from the ‘unstressed’ reservoir to the ‘stressed’ reservoir, an undesirable influx of blood volume to the already overloaded left heart can be avoided. Certain embodiments provide ways to maintain or to increase atrial elasticity, or atrialcompliance. This increase or enhancement of atrial compliance enables the atrium to ‘absorb’ the energy of short bursts of high left atrial pressure. Consequences of such embodiments are a reduction in the retrograde flow in the pulmonary veins to inhibit or prevent acute pulmonary congestion.

[0061] The technologies disclosed herein provide a variety of ways to inhibit or prevent backward propagation of elevated pressures from the left heart to the pulmonary vasculature. This can be achieved by reducing the blood flow into the heart and lungs and / or by enhancing atrial compliance to handle temporal increases in left atrial pressure. Examples of these technologies include balloons and balloon pumps in the left atrium to enhance atrial compliance, right-sided reservoirs, portal vein chokes to limit the amount of blood entering the left atrium, compliant materials implanted in the atrial septum to add compliance to the left heart during filling and emptying, balloons that effectively add compliant volume to the left atrium, compliant tubes with valves, and the like.

[0062] Advantageously, enhancing compliance of the left atrium can inhibit or prevent adverse effects due to diastolic dysfunction. For example, diastolic dysfunction can reduce the compliance of the left atrium, meaning that there is an increase in pressure for the same volume in the left atrium. The patient can experience elevated left atrial pressure (associated with many negative symptoms and a poor prognosis) which may progress to heart failure. Increasing or enhancing atrial compliance results in the atrium accepting more blood which may lead to beneficial results, such as a reduction in transmission back to the lungs.

[0063] In some embodiments, the disclosed technologies can be used as an alternative to shunting the left atrium. This may be beneficial because it does not introduce oxygenated blood to the right atrium.

[0064] In some embodiments, the disclosed technologies are configured to react to pressures and / or pressure differentials between in the heart. By way of reference, a typical cardiac cycle results in the ejection of about 50 mL to about 100 mL of blood per heartbeat and for a patient with heart failure the ejection volume can be lower, e.g., about 30 mL. Accordingly, to provide a clinically significant pressure drop, the disclosed technologies can be configured to provide a significant fraction of volume removal. For example, in devices disclosed herein that include balloons or other such components, the size of the balloon can be configured to generate the targeted range of volume removal (e.g., about 15 mL - 20 mL).Example Portal Vein Chokes

[0065] FIG. 1 illustrates an example portal vein choke 150 that is configured to reduce blood flow to the heart. The portal vein choke 150 is configured to constrict the portal vein 12 toreduce blood flow though that vein. The portal vein choke 150 addresses diastolic dysfunction by decreasing the blood flow from an unstressed reservoir, e.g., the splanchnic system, to the stressed reservoir, e.g., the heart and lungs.

[0066] The bulk of the unstressed blood that is recruited under exertion or stress flows through the portal vein 12. The portal vein 12 drains the spleen and the gut into the liver 14, which in turn drains into the inferior vena cava (IVC 10) and back to the right side of the heart. For example, the hepatic veins 9 drain venous blood from the liver 14 into the IVC 10. The portal vein 12 provides approximately 75% of the blood flow to the liver 14. Thus, restricting the portal vein 12 in patients with diastolic dysfunction can reduce or prevent recruitment of unstressed blood volume during exertion to enter the stressed blood reservoir (e.g., the heart). This, in turn, can prevent pulmonary congestion.

[0067] The portal vein choke 150 includes a first anchor 154a and a second anchor 154b with a tether 156 having a first bulb 152a and a second bulb 152b on either end of the tether 156. The first anchor 154a is configured to be positioned on an exterior wall of the portal vein 12 and the second anchor 154b is configured to be positioned within the IVC 10. That is, the tether 156 is configured to pass through a wall of the IVC 10 to exit the IVC 10, to pass through a first side of the wall of the portal vein 12, passing through the lumen of the portal vein 12, and to pass through a second side of the wall of the portal vein 12 to exit the portal vein 12. The first bulb 152a is configured to provide sufficient surface area against the first anchor 154a so that providing tension on the tether 156 pulls the first anchor 154a toward the second anchor 154b without the first bulb 152a pulling through the first anchor 154a. Similarly, the second bulb 152b is configured to provide sufficient surface area against the second anchor 154b so that providing tension on the tether 156 pulls the second anchor 154b toward the first anchor 154a without the second bulb 152b pulling through the second anchor 154b. Thus, the tether 156 with the first bulb 152a and second bulb 152b is configured to pull the first anchor 154a towards the second anchor 154b to cinch or restrict (e.g., to reduce a cross-sectional size of the interior lumen) the portal vein 12 to restrict blood flow through the portal vein 12.

[0068] The first anchor 154a and the second anchor 154b can be made of any sufficient biocompatible material. For example, the first and second anchors 154a, 154b can be pledgets. The first and second anchors 154a, 154b can be configured to provide sufficient surface area against the walls of the targeted vessels to enable the tether 156 to pull the first and second anchors 154a, 154b toward one another to choke the targeted vessel (e.g., the portal vein 12). The tether 156 with the first bulb 152a and second bulb 152b can be made of any sufficient biocompatible material. For example, the tether 156 can be a suture with knots forming the bulbs 152a, 152b. In someimplementations, the tether 156 does not include bulbs but is coupled to the first anchor 154a and the second anchor 154b using other means.

[0069] To implant the portal vein choke 150, a catheter or other such delivery device can descend through the IVC 10 to exit at a point where the IVC 10 and the portal vein 12 are close together and approximately parallel. The delivery device can puncture through the interior wall of the IVC 10 and through the portal vein 12 to deploy the first anchor 154a on the outside of the wall of the portal vein 12. The delivery device can deploy the second anchor 154b on an interior wall of the IVC 10. The delivery device can tension the tether 156 to pull the first anchor 154a toward the IVC 10 and / or adjust the relative positions of the first anchor 154a and the second anchor 154b to achieve targeted restriction on the portal vein 12. In some implementations, the portal vein choke 150 can be implanted into the superior mesenteric vein 13, inferior mesenteric vein, splenic vein, or the confluence of the splenic and inferior mesenteric veins 16.

[0070] The portal vein choke 150 is configured to provide a functional approach to reducing blood volume to the heart because the portal vein choke 150 acts as a limiter. For example, the change in blood flow is represented by a first blood flow 111 below the portal vein choke 150 that is reduced to the second blood flow 113 above the portal vein choke 150. Restricting blood flow through the portal vein 12 reduces blood volume to the heart, which in turn reduces pressure in the left atrium. Advantageously, this approach to addressing diastolic dysfunction does not introduce oxygenated blood into the right atrium and does not change flow patterns in the heart, as would be the case of shunting between the left and right atria. Shunting between the left and right atria results in a tradeoff, a reduction in pressure but an increase in volume. In contrast, the portal vein choke 150 results in a different tradeoff, putting more blood into other systems (e.g., the splanchnic system) but reducing the volume of blood to the heart.

[0071] A method can be implemented for implanting the portal vein choke 150 to reduce blood flow to the heart. The method includes using a delivery device, such as a catheter, to deliver the portal vein choke 150 through the IVC 10 to a point where the IVC 10 and the portal vein 12 are approximately parallel. The method includes puncturing through an interior wall of the IVC 10 and through the portal vein 12 to access an exterior wall of the portal vein 12. Puncturing can be accomplished using a puncturing device, such as a needle, extending from the delivery device. The method then includes deploying the first anchor 154a on the exterior wall of the portal vein 12. The method then includes deploying the tether 156 by securing a distal end of the tether 156 to the first anchor 154a. The method then includes deploying the second anchor 154b on the interior wall of the IVC 10. The method then includes adjusting the tension on the tether 156 to provide a targeted tension configured to approximate the first anchor 154a to the second anchor 154b to effectively reduce a cross-sectional lumen size of the portal vein 12. The method includes securing a proximalend of the tether 156 to the second anchor 154b in the tensioned state to maintain force on the portal vein 12, thereby reducing blood flow through the portal vein 12.

[0072] FIG. 2A illustrates another example of a portal vein choke system 250 that includes a lower portal vein choke 250a and an upper portal vein choke 250b. The lower portal vein choke 250a and the upper portal vein choke 250b are each similar to the portal vein choke 150 described herein with reference to FIG. 1, with some differences. In particular, the lower portal vein choke 250a includes a lower conduit 256 and the upper portal vein choke 250b includes an upper conduit 255 that each serves a function similar to the tether 156 of the portal vein choke 150. In addition, each of the lower conduit 256 and the upper conduit 255 provides additional functionality relative to the tether 156. In particular, the lower conduit 256 includes an injection port 258 through which fluid can be injected into the portal vein 12 and the upper conduit 255 includes a temperature sensor 257 that is configured to measure the temperature of the fluid flowing through the portal vein 12. In combination, the lower portal vein choke 250a and the upper portal vein choke 250b can be used to calculate flow rates through the portal vein 12 using thermal dilution. For example, the injection port 258 can be used to inject a warm saline solution into the portal vein 12 and the temperature sensor 257 can be used to measure the temperature of the fluid at the upper conduit 255 (the fluid being a combination of the injected saline solution and blood). Based on the measured temperature, the portal vein choke system 250 can be used to determine a flow rate through the portal vein 12. The upper portal vein choke 250b can also be considered to be downstream of the lower portal vein choke 250a or the lower portal vein choke 250a can be considered to be upstream of the upper portal vein choke 250b.

[0073] FIGS. 2B-2E illustrate an example of implanting the portal vein choke system 250. FIG. 2B illustrates a delivery device 210 that includes a first conduit 210a through which the lower portal vein choke 250a is delivered and a second conduit 210b through which the upper portal vein choke 250b is delivered. The delivery device 210 descends through the IVC 10 and the first conduit 210a is used to puncture through the interior wall of the IVC 10 and through the portal vein 12, as described in greater detail herein with reference to FIG. 1. A first lower anchor 254a is deployed outside of the portal vein 12.

[0074] FIG. 2C illustrates the second conduit 210b puncturing through the interior wall of the IVC 10 and through the portal vein 12 above the lower portal vein choke 250a. A first upper anchor 253a is deployed outside of the portal vein 12. In addition, the first lower anchor 254a is pulled to begin cinching the portal vein 12 with the lower portal vein choke 250a. This positions the injection port 258 within the portal vein 12.

[0075] FIG. 2D illustrates the first upper anchor 253a being pulled to cinch a second portion of the portal vein 12. This positions the temperature sensor 257 within the portal vein 12.The upper portal vein choke 250b is configured to cinch the portal vein at a location above or downstream of the location where the lower portal vein choke 250a cinches the portal vein 12.

[0076] FIG. 2E illustrates deployment of a second lower anchor 254b and a second upper anchor 253b configured to anchor the lower portal vein choke 250a and the upper portal vein choke 250b, respectively, to the IVC 10 and the portal vein 12. After anchoring the lower portal vein choke 250a and the upper portal vein choke 250b the delivery device 210 can be withdrawn leaving the lower conduit 256 and the upper conduit 255 communicably coupled to the first conduit 210a and the second conduit 210b, as illustrated in FIG. 2A. In some implementations, the lower conduit 256 is a distal portion of the first conduit 210a and the upper conduit 255 is a distal portion of the second conduit 210b.

[0077] With reference to FIG. 2A, thermal dilution can be used to measure flow rate through the portal vein 12. This can be used as feedback to an operator who can then adjust the restriction of the portal vein 12 by adjusting the second lower anchor 254b and / or the second upper anchor 253b.

[0078] FIG. 3 illustrates another example of a portal vein choke 350 that acts as a selfregulating portal vein choke. Similar to the portal vein choke 150 described herein with reference to FIG. 1, the portal vein choke 350 includes a first anchor 354a and a second anchor 354b with a conduit 356 between the first anchor 354a and the second anchor 354b. Unlike the portal vein choke 150, the portal vein choke 350 includes a balloon 358 configured to be positioned between the first anchor 354a and the outer wall of the portal vein 12. The conduit 356 includes a port 357 from the conduit 356 to the balloon 358. The port 357 is configured to be positioned external to the portal vein 12. The conduit 356 and the balloon 358 act as a sealed system with a fluid 320 (gas or liquid) within the sealed system. Furthermore, the conduit 356 includes a pliable membrane 353 at a second end of the portal vein choke 350 near the second anchor 354b, the conduit 356 forming an open end at the second end that is covered by the pliable membrane 353, forming a seal for the sealed system, the sealed system comprising the pliable membrane 353, the conduit 356, and the balloon 358. The pliable membrane 353 is exposed to the blood flow through the IVC 10.

[0079] The portal vein choke 350 is configured to adjust inflation of the balloon 358 based on differentials in central venous pressure (CVP) and portal vein pressure. When CVP is greater than portal vein pressure, the blood pushes the pliable membrane 353 inside the conduit 356, pushing fluid 320 from the conduit 356 to the balloon 358 through the port 357. Inflation of the balloon 358 restricts the portal vein 12, thereby restricting flow through the portal vein 12. The first anchor 354a acts as a backstop to influence the balloon 358 to spread along the portal vein 12 rather than away from the portal vein 12. This aids in restricting the portal vein 12 responsive to the pliable membrane 353 inflating. When portal vein pressure is similar to CVP, the pliable membrane353 returns to being approximately flat or flush with the wall of the IVC 10 due at least in part to the pressure within the sealed system, resulting in the balloon 358 deflating and pushing the fluid 320 back into the conduit 356 through the port 357. Thus, the portal vein choke 350 acts as a selfregulating portal vein choke because it automatically responds to pressure differentials between CVP in the IVC 10 and pressure in the portal vein 12.

[0080] The first anchor 354a and / or the second anchor 354b can be made of any suitable material, such as a shape memory alloy. The shape of the second anchor 354b can be configured to influence the balloon 358 to spread along the exterior of the wall of the portal vein 12 when the balloon 358 inflates with the fluid 320. The fluid can be a gas or a liquid, such as a saline solution. The conduit 356 can be a shunt or other similar conduit. The pliable membrane 353 can be a baffle or other similar membrane.

[0081] The portal vein choke 350 can be implanted in a similar manner to the portal vein choke 150 described herein with reference to FIG. 1 and / or the portal vein choke system 250 described herein with reference to FIGS. 2A-2E. The first anchor 354a and the second anchor 354b can be configured to be in a delivery configuration (e.g., crimped) and can be configured to selfdeploy or to be deployed after being removed from a delivery device, such as a catheter.Bulging membrane between right atrium and left atrium

[0082] FIGS. 4A, 4B, and 4C illustrate a bulging membrane 430 implanted in the septum 20 between the left atrium 2 and the right atrium 5 of the heart 1. FIGS. 4 A and 4B illustrate a cross-section of the bulging membrane 430 as implanted in the heart 1. FIG. 4C illustrates a front view of the bulging membrane 430.

[0083] The bulging membrane 430 includes an anchor structure, such as an annular seal 432, supporting a deformable membrane, such as an inner compliant membrane 434. The annular seal 432 is configured to be anchored between in the septum 20 between the left atrium 2 and the right atrium 5 in an opening made there. This allows a pressure differential to cause the inner compliant membrane 434 to bulge into the right atrium 5 to effectively increase or enhance atrial compliance and / or to effectively increase the volume of the left atrium 2 in response to a left atrial pressure that exceeds the right atrial pressure. For example, FIG. 4A illustrates the bulging membrane 430 where the pressure in the left atrium 2 is less than about 25 mmHg and FIG. 4B illustrates the bulging membrane 430 where the pressure in the left atrium is greater than about 25 mmHg.

[0084] The inner compliant membrane 434 is configured to respond to a threshold pressure and / or a threshold pressure differential. In some implementations, the amount that the inner compliant membrane 434 bulges into the right atrium 5 can be related to the pressure differentialbetween the atria. In certain implementations, the inner compliant membrane 434 can be configured to bulge a relatively fixed amount when the pressure or pressure differential exceeds a targeted amount (e.g., about 25 mmHg or between about 20 mmHg and about 30 mmHg).

[0085] The bulging membrane 430 is configured to be positioned flush within the septum 20 between the left atrium 2 and right atrium 5. In various implementations, when the pressure in the left atrium exceeds a clinically relevant value, e.g., about 25 mmHg, the inner compliant membrane 434 is configured to deform into the right atrium 5 to increase the effective volume in the left atrium 2 and thus increase atrial compliance. When the pressure starts to reduce to below the critical value, e.g., about 25 mmHg, during ventricular diastole, the inner compliant membrane 434 is configured to return to its original configuration and aid in ventricular diastolic filling. In some implementations, the material properties of the inner compliant membrane 434 are such that it deforms at specific pressure conditions in the left atrium 2. In some implementations, the inner compliant membrane 434 is configured to be stiff in one direction and compliant in another direction. In such implementations, the inner compliant membrane 434 is configured to bulge into the right atrium 5 and to not bulge into the left atrium 2. In some implementations, the inner compliant membrane 434 is configured to be compliant in both directions. In such implementations, the inner compliant membrane 434 is configured to bulge into the right atrium 5 and into the left atrium 2.

[0086] The bulging membrane 430 is configured to be delivered in an approach similar to a transseptal approach. That is, it is similar to implanting a device where the septum 20 is crossed. This allows the bulging membrane 430 to be positioned within the septum 20. The annular seal 432 of the device is configured to anchor to the septum wall. The annular seal 432 can be made of any suitable material. For example, the annular seal 432 can include an oversized Nitinol frame and / or tissue engaging bars. The bulging membrane 430 is different from a shunt because the inner compliant membrane 434 seals the hole created in the septum 20 rather than allowing for fluid to flow between the left atrium 2 and the right atrium 5.

[0087] The bulging membrane 430 is configured to effectively reduce pressures in the left atrium 2 by providing more volume when the pressure exceeds a target value. Advantageously, this also effectively dampens peak high pressure in the left atrium 2.Right atrium reservoir

[0088] FIGS. 5A and 5B illustrate a right atrium reservoir 530 that is configured to provide interatrial fluidic communication. The right atrium reservoir 530 includes an anchor structure, such as a frame 532, configured to anchor to the septum 20 and a deformable membrane, such as a deformable diaphragm 534, that is configured to inflate (or fill) and to deflate (or empties)responsive pressures in the right atrium 5. FIG. 5A illustrates that the deformable diaphragm 534 diaphragm inflates and fills with deoxygenated blood from the right atrium 5 when the right atrial pressure exceeds a threshold value (e.g., about 10 mmHg or between about 8 mmHg and about 12 mmHg). FIG. 5B illustrates that the deformable diaphragm 534 deflates and becomes flush with the septum 20 on the left atrial side when the right atrial pressure is less than the threshold value (e.g., about 10 mmHg or between about 8 mmHg and about 12 mmHg). 0089] The right atrium reservoir 530 is an implant positioned in the interatrial septum 20 and contains the deformable diaphragm 534 that is configured to allow the right atrium 5 to accommodate increased venous return (e.g., during exercise or during increased sympathetic activation) to prevent increases in left atrium volume and left atrial pressure. The deformable diaphragm 534 has material properties that are tailored to allow deformation to occur once the net pressure gradient between the right atrium and the left atrium exceeds a threshold value (e.g., about 10 mmHg or between about 8 mmHg and about 12 mmHg). The deformable diaphragm 534 can either bulge into the left atrium 2 to attenuate right atrial pressure or to bulge into the right atrium 5 to attenuate left atrial pressure. In some implementations, decreasing the volume in the left atrium 2 causes the blood volume in the left atrium 2 to decrease advantageously resulting in a reduction in left atrial pressure. Furthermore, decreasing the fill in the left atrium 2 may also advantageously generate less pressure upon contraction.

[0090] In some implementations, the deformable diaphragm 534 can be configured to fill another space other than the left atrium 2 and / or the right atrium 5. For example, the deformable diaphragm 534 can be configured to extend outside of the heart 1 to effectively increase the volume of the left atrium 2 or the right atrium 5. Such implementations may provide certain benefits because effectively decreasing the volume of one atrium while effectively increasing the volume of the other atrium may undesirably increase the pressure in the atrium whose volume was effectively reduced due to the inflation of the deformable diaphragm 534.Pressure balloon syringe

[0091] FIGS. 6A, 6B, 6C, 6D, 6E, 6F, and 6G illustrate an example of a pressure balloon syringe 630 that is configured to be implanted in the septum 20 between the left atrium 2 and the right atrium 5. The pressure balloon syringe 630 includes a body or housing that forms a nose portion 634 and a tail portion 636 with a piston 632 forming a movable seal between the nose portion 634 and the tail portion 636 to change the volume of the nose portion 634 and the tail portion 636. The pressure balloon syringe 630 also includes a balloon 638 in fluidic communication with the tail portion 636. In addition, the nose portion 634 forms an opening 635 to be in fluidic communication with the left atrium 2, when implanted in the septum 20. The pressure balloonsyringe 630 also includes an anchor 631 that is configured to seal the tail portion 636 and the balloon 638 that together form a closed fluid system after implanting in the septum 20.

[0092] FIG. 6 A illustrates a delivery device 610 configured to deliver and implant the pressure balloon syringe 630. The delivery device 610 is configured to cross the septum 20, forming an opening in the septum 20, similar to a transseptal approach.

[0093] FIG. 6B illustrates deployment of the pressure balloon syringe 630 from the delivery device 610. The delivery device 610 includes a delivery conduit 612 that is in fluidic communication with the tail portion 636 of the pressure balloon syringe 630. The delivery device 610 is configured to push out the pressure balloon syringe 630 from a distal end of the delivery device 610 into the left atrium 2. Upon delivery into the left atrium 2, the opening 635 of the tail portion 636 is primed with blood from the left atrium 2. In some implementations, this is done by withdrawing the piston 632 away from the nose portion 634 when the pressure balloon syringe 630 is positioned in the left atrium 2.

[0094] FIG. 6C illustrates the delivery device 610 retracting and pivoting the pressure balloon syringe 630 to cause the pressure balloon syringe 630 to be positioned against the septum 20. In some implementations, the pressure balloon syringe 630 is rotated about 90 degrees. Once in this position, the delivery device 610 is configured to inflate the balloon 638 with fluid (e.g., gas) through the delivery conduit 612, as illustrated in FIG. 6D. The pressure of the fluid system comprising the tail portion 636 and the balloon 638 is configured to be a target pressure (e.g., about 15 mmHg).

[0095] FIG. 6E illustrates decoupling of the delivery device 610 from the pressure balloon syringe 630. In addition, the pressure balloon syringe 630 is anchored to the septum 20 using the anchor 631. In addition to anchoring the pressure balloon syringe 630 to the septum 20, the anchor 631 seals the fluid system comprising the tail portion 636 and the balloon 638.

[0096] FIGS. 6F and 6G illustrate operation of the pressure balloon syringe 630 once it is implanted in the septum 20. FIG. 6F illustrates that when the left atrial pressure exceeds a threshold amount (e.g., about 25 mmHg or between about 20 mmHg and about 30 mmHg), the balloon 638 deflates because the threshold pressure exceeds the target pressure in the balloon 638. This pushes the piston 632 into the nose portion 634, expelling blood from the nose portion 634 through the opening 635. FIG. 6G illustrates that when the left atrial pressure is less than a threshold amount (e.g., about 10 mmHg or between about 8 mmHg and about 12 mmHg), the balloon 638 inflates and the piston 632 is pushed toward the tail portion 636 by blood filling the nose portion 634 because the blood is at a higher pressure than the target pressure in the balloon 638.

[0097] By way of example, as illustrated in FIGS. 6A-6E, the pressure balloon syringe 630 is delivered via a catheter-based system that delivers the pressure balloon syringe 630 into the leftatrium. First, the distal tip of the catheter is advanced from the right atrium 5 through the interatrial septum 20 and into the left atrium 2 via a piercing tip on the distal end of the catheter. The distal tip is conical in shape, which is then advanced further into the left atrium 2 via translation of a nested catheter, intraluminal to the larger access catheter, which is attached to the conical distal tip. The conical distal tip is comprised of a syringe type cavity, with an internal, moveable piston 632, and an open orifice or opening 635 at the very distal tip or nose portion 634 of the cone. Behind the piston 632, inside the conical syringe, is a fluid (e.g., air). The proximal end or tail portion 636 of the distal cone syringe is connected to a gas filled balloon 638 which unfolds to sit in the left atrium. For delivery, the distal cone is rotated and retracted back onto the septum 20 where it is anchored in-place to the septum 20. The balloon 638 is inflated through the delivery catheter to a target pressure and volume. The delivery catheter is then fully retracted.

[0098] The pressure balloon syringe 630 operates as follows, as illustrated in FIGS. 6F and 6G. During lower pressure hemodynamic filling of the left atrium (left atrium diastole), the difference between the (high) gas pressure in the balloon 638 and the (low) pressure in the left atrium causes the balloon 638 to expand and the piston 632 to draw blood into the nose portion 634 of the pressure balloon syringe 630. During atrial systole, the relative difference between the (high) left atrium pressure and the (low) balloon pressure causes a restriction to the balloon 638 thereby pushing the piston 632 to expunge blood from the nose portion 634. The effect is to give the left atrium a measure of hemodynamic compliance. With the balloon inflated, filling of the left atrium is limited. With the balloon deflated, the blood in the nose portion 634 is expelled for advantageous late filling of the left atrium.Left atrial balloon pump

[0099] FIGS. 7A and 7B illustrate an example of a left atrial balloon pump 740 that includes a balloon 742 that is in fluidic communication with an extravascular reservoir 748 through a catheter 746. The left atrial balloon pump 740 also includes a guidewire 744 with an atraumatic tip for delivery of the balloon 742 into the left atrium 2 of the heart 1. The left atrial balloon pump 740 can be an active or passive balloon pump.|01001 FIG. 7A illustrates the left atrial balloon pump 740 during ventricular systole. In this portion of the cardiac cycle, the balloon 742 is deflated. In some implementations, the balloon 742 is configured to deflate when the left atrial pressure is greater than the pressure of the fluid in the extravascular reservoir 748. FIG. 7B illustrates the left atrial balloon pump 740 during ventricular diastole. In this portion of the cardiac cycle, the balloon 742 is inflated. In some implementations, the balloon 742 is configured to inflate when the left atrial pressure is less than the pressure of the fluid in the extravascular reservoir 748.- l-

[0101] The left atrial balloon pump 740 comprises a passive balloon pump positioned in the left atrium 2 via a transseptal puncture through the interatrial septum and delivery through a percutaneous sheath positioned in a peripheral vein (e.g., a femoral vein or internal jugular vein). The left atrial balloon pump 740 includes the balloon 742 that is coupled to a multi-lumen catheter body, the catheter 746. The catheter 746 has a central lumen for the guidewire 744 to ensure atraumatic delivery into the heart chambers. The catheter 746 has a separate lumen that allows for fluid exchange (e.g., helium gas or another inert gas) between the balloon 742 and the extravascular reservoir 748. By way of example, the extravascular reservoir 748 can be placed in the thoracic cavity or in the subcutaneous space. Movement of fluid between the balloon 742 and the extravascular reservoir 748 is regulated by the internal pressure of the extravascular reservoir 748 and the cavity pressure in the left atrium 2. In some implementations, the left atrial balloon pump 740 can include a two-way pressure regulated valve that provides additional control on fluid movement between the balloon 742 and the extravascular reservoir 748.

[0102] The left atrial balloon pump 740 is configured to reduce the peak left atrial pressure during ventricular systole (the V wave). The left atrial balloon pump 740 operates to reduce the peak left atrial pressure during the V wave by way of pressure differentials between the extravascular reservoir 748 and the pressure in the left atrium 2. That is, when the cavity pressure in the left atrium 2 exceeds the internal pressure inside the balloon 742, fluid is moved from the balloon 742 to the extravascular reservoir 748 through compression of the gas (that is, the balloon 742 is deflated). The reduction of balloon volume in the left atrium 2 enhances compliance of the left atrium 2 which lowers the pressure in the left atrium 2. When the cavity pressure in the left atrium 2 is less than the reservoir pressure, the balloon 742 inflates because fluid is moved from the extravascular reservoir 748 to the balloon 742. The pressure in the extravascular reservoir 748 can be set so that in ventricular diastole the extravascular reservoir 748 pushes blood into the left ventricle (e.g., by inflating balloon 742) and when in ventricular systole, the balloon 742 deflates. In some implementations, the left atrial balloon pump 740 is an active system that sends energy to the left atrial balloon pump 740 to inflate and deflate the balloon 742. In some implementations, the left atrial balloon pump 740 is configured to inflate the balloon 742 to reduce volume in the left atrium 2 so that when the left atrium 2 contracts, there is less volume to push against, reducing the overall blood volume.

[0103] FIG. 7C illustrates a trio of graphs that demonstrate an example or simulation of the effect of the left atrial balloon pump 740 in a patient. The top graph represents a sample ECG tracing of a single cardiac beat. The middle graph represents the left atrial pressure (LAP, in mmHg) for a sample healthy adult (without operation of the left atrial balloon pump 740). The solid line in the bottom graph represents the left atrial pressure (LAP, in mmHg) for a patient with heartfailure with elevated left atrial pressure. This is indicated by an increase in magnitude of the V wave. The dashed line represents the left atrial pressure for the patient while the left atrial balloon pump 740 is operating. This indicates a reduced V wave pressure and an increased A wave pressure. Together, these graphs illustrate the hemodynamic change of left atrial pressure during the cardiac cycle with the left atrial balloon pump 740. In other words, when the balloon 742 collapses or deflates, the pressure is damped in the left atrium thereby advantageously reducing the V wave. The balloon 742 therefore enhances compliance of the left atrium and improves ventricular filling.Passive left atrium and IVC / HV balloon pump

[0104] FIGS. 8A and 8B illustrate an example of a balloon pump system 840a that acts as a passive pump for balloons in the left atrium 2 and the IVC 10. FIGS. 8C and 8D illustrate an example of a balloon pump system 840b that acts as a passive pump for balloons in the left atrium 2 and one or more of the hepatic veins 9. Each balloon pump system 840a, 840b includes a first balloon 842 positioned in the left atrium 2, an extravascular reservoir 848, a catheter 846 that is in fluid communication with the extravascular reservoir 848, and a guidewire 844 for delivery and implantation of the balloon pump systems 840a, 840b. FIGS. 8 A and 8B illustrate that the balloon pump system 840a includes a second balloon 843 positioned in the IVC 10 while FIGS. 8C and 8D illustrate that the balloon pump system 840b includes a second balloon 845 positioned in one or more of the hepatic veins 9. In some implementations, the catheter 846 comprises a three-lumen catheter.

[0105] FIG. 8A illustrates the balloon pump system 840a during ventricular diastole. The first balloon 842 inflates when left atrial pressure is below the fluid pressure in the extravascular reservoir 848. In turn, the second balloon 843 deflates when the left atrial pressure is below a threshold value (e.g., about 15 mmHg).

[0106] FIG. 8B illustrates the balloon pump system 840a during ventricular systole. The first balloon 842 deflates and the second balloon 843 inflates when the left atrial pressure is above the threshold value (e.g., about 15 mmHg).101071 FIG. 8C illustrates the balloon pump system 840b during ventricular diastole. The extravascular reservoir 848 is pressurized to fill the first balloon 842 when left atrial pressure is less than the threshold value (e.g., about 15 mmHg). In addition, the second balloon 845 is deflated when the first balloon 842 is inflated because the first balloon 842 and the second balloon 845 are in fluidic communication.

[0108] FIG. 8D illustrates the balloon pump system 840a during ventricular systole. The first balloon 842 deflates, moving the fluid from the first balloon 842 to the second balloon 845 toinflate the second balloon 845. This occurs when the left atrial pressure is below the threshold value (e.g., about 15 mmHg).

[0109] In some embodiments, the balloon pump systems 840a, 840b each include two passive balloons, the first balloon 842 and the second balloon 843 or 845, that are inflated from the extravascular reservoir 848. To implant either balloon pump system 840a, 840b, venous access is used with a standard transseptal (atrial) puncture to access the left atrium. Over the guidewire 844, the catheter 846 comprising a triple lumen catheter is advanced using the central lumen for the guidewire rail. One lumen is used to inflate the first balloon 842 and the remaining lumen is used to inflate the second balloon 843 or 845. Balloon inflation is managed by the extravascular reservoir 848.

[0110] The extravascular reservoir 848 is configured to pressurize the first balloon 842 (where the total balloon volume depends at least in part on the left atrial volume of the patient) while the left atrial pressure is below the threshold value (e.g., about 15 mmHg) which is configured to occur during ventricular diastole. While in this portion of the cardiac cycle, the second balloon 843 or 845 is deflated. Once the mitral valve closes signaling the start of ventricular systole and the filling pressure in the left atrium rises above the threshold value (e.g., about 15 mmHg), the first balloon 842 is configured to deflate and to send the gas into the second balloon 843. The second balloon 843 or 845 (either in the IVC 10 or the hepatic vein(s) 9, respectively) is configured to be sufficiently sized and inflated to occlude the respective vessel while the second balloon 843 or 845 is inflated. In some implementations, there is an extravascular reservoir for each balloon (the first balloon 842 and the second balloon 843 or 845). In some implementations, there is a check regulator between the first balloon 842 and the second balloon 843 or 845. In some implementations, the balloon pump system 840b may provide benefits to certain patients because the second balloon 845 does not increase the load the kidney sees.Anti-stasis Compliance Bypass

[0111] FIG. 9 illustrates a device 900 configured for implantation in the left atrial appendage (LAA) 920, the device 900 designed to provide anti-stasis compliance bypass to the heart. As described herein, there is a need to add compliance to the left atrium to prevent backwards pressure transmission from the left heart to the pulmonary vasculature in patients with atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). The device 900 includes a compliant casing 902 that is partitioned with a partition 904 placed in the LAA 920. The compliant casing 902 defines a flow path from an inlet valve 906 to an outlet valve 908. This flow path provides a lumen for blood flow responsive to changes in left atrial pressure. The device 900 increases atrial compliance in a manner that reduces or eliminates the risk of thrombus formationby providing a flow of blood through the lumen without creating regions of stasis. In some implementations, the device 900 includes a partition 904 that defines the lumen through the device 900 from the inlet valve 906 to the outlet valve 908.

[0112] A risk that may present in balloons or other such devices is blood stasis in the balloon. Specifically, if the balloon is not completely drained at lower pressures, blood that accumulates within the balloon for a relatively long period of time may lead to thrombosis and clots that can flow into the blood stream and cause adverse clinical outcomes.

[0113] The device 900 provides an anti-stasis compliance bypass valve to force blood flow through the valve while providing enhanced atrial compliance. The device 900 can include unidirectional valves (e.g., the inlet valve 906 and / or the outlet valve 908) that force blood flow in one direction through the lumen defined by the partition 904 in the device 900. The inlet valve 906 provides for blood flow from the left atrium 2 into the lumen of the device 900, and the outlet valve 908 provides for blood flow from the lumen of the device 900 back into the left atrium 2.

[0114] The device 900 can be compliant so that the device 900 can expand under elevated pressures. When the pressure inside the left atrium 2 increases, the inlet valve 906 opens (while the outlet valve 908 closes), allowing blood to flow from the left atrium 2 into the additional volume available in the device 900. In some implementations, the device 900 expands responsive to the elevated or high pressures. When the pressure in the left atrium 2 drops, the higher blood pressure still inside the device 900 causes the inlet valve 906 to close and causes the outlet valve 908 to open. This allows at least a portion of the blood within the device 900 to exit the device 900 through the outlet valve 908 and into the left atrium 2. In some implementations, this can shrink the device 900 back to its free-state diameter.

[0115] In some embodiments, the device 900 includes the compliant casing 902 with the partition 904 that is placed in the LAA 920. The partition 904 and the compliant casing 902 form a lumen to provide a flow path through the device 900 from the inlet valve 906 to the outlet valve 908. Advantageously, the flow of blood through the flow path of the compliant casing 902 from the inlet valve 906 to the outlet valve 908 inhibits stasis and reduces or eliminates risks associated with thrombosis due to flow stagnation. In some implementations, the device 900 does not include the inlet valve 906 and / or the outlet valve 908.

[0116] FIG. 10 illustrates a device 1000 with a compliant tube 1002 that is configured to provide anti-stasis compliance bypass to the heart. The device 1000 is similar to the device 900 described herein with reference to FIG. 9 except that the device 900 is implanted within the LAA.

[0117] As described herein, there is a need to add compliance to the left atrium to prevent backwards pressure transmission from the left heart to the pulmonary vasculature in Afib and HFpEF patients. The device 1000 comprises a compliant tube 1002 extending through a punctureformed in the wall of the left atrium 2. The compliant tube 1002 defines a flow path between an inlet valve 1006 to an outlet valve 1008. In some implementations, the inlet valve 1006 and / or the outlet valve 1008 is a unidirectional valve. The compliant tube 1002 with the inlet valve 1006 and the outlet valve 1008 provide a lumen into which blood can flow into and out of in response to changes in left atrial pressure. This flow path increases left atrial compliance in a manner that reduces or eliminates the risk of thrombus formation due at least in part to a constant flow of blood through the lumen without creating regions of stasis.

[0118] In some implementations, the device 1000 can be implanted in a puncture of the left atrial wall using a sealing ring 1004. The sealing ring 1004 can be configured to reduce or eliminate blood leakage through the puncture in the left atrial wall. The compliant tube 1002 extends from the puncture of the left atrial wall and utilizes the inlet valve 1006 and the outlet valve 1008 to define a flow path for blood flow to effectively increase atrial compliance. In some implementations, the inlet valve 1006 and the outlet valve 1008 can be configured to force the flow of blood in one direction along the compliant tube 1002 through the use of unidirectional valves. The inlet valve 1006 is configured to allow blood to flow from the left atrium 2 into the compliant tube 1002 and the outlet valve 1008 is configured to allow blood to flow from the compliant tube 1002 back into the left atrium 2.

[0119] The compliant tube 1002 is itself compliant. This allows the compliant tube 1002 to expand under elevated pressures. Thus, when the pressure inside the left atrium 2 increases, the inlet valve 1006 opens (while the outlet valve 1008 is closed), allowing blood to flow from the left atrium 2 into the additional volume available in the compliant tube 1002. In some implementations, the compliant tube 1002 also expands under elevated pressures in the left atrium 2. When the pressure in the left atrium 2 drops, the higher blood pressure still inside the compliant tube 1002 causes the inlet valve 1006 to close and causes the outlet valve 1008 to open. This allows blood to evacuate through the outlet valve 1008 from the compliant tube 1002 into the left atrium 2. In some implementations, this can also result in the compliant tube 1002 shrinking back to a low-pressure size that is smaller than the high-pressure size.

[0120] In some implementations, the compliant tube 1002 can extend through the puncture in the left atrial wall into pericardial space. In some implementations, the compliant tube 1002 can assume a relatively flattened or oblong path to fit under the pericardium.

[0121] It is to be understood that, in some implementations, the wall of the left atrium 2 does not have to be punctured twice, one for the inlet and one for the outlet of the compliant tube 1002. Instead, the device 1000 can be implanted through a single puncture in the wall of the left atrium 2. Through the single puncture, the inlet valve 1006 and the outlet valve 1008 can be positioned side-by-side.Atrial Enhancement Balloon Extending from the Wall of the Atrium

[0122] FIG. 11 illustrates an atrial enhancement balloon device 1100 extending from the wall of the left atrium 2. The atrial enhancement balloon device 1100 is configured to add compliance to the left atrium 2 to inhibit or prevent backwards pressure transmission from the left heart to the pulmonary vasculature. The atrial enhancement balloon device 1100 comprises a balloon 1102 extending through a puncture formed in the wall of the left atrium 2. The balloon 1102 provides an expandable volume that is adapted to inflate during systole to add available volume to the left atrium 2 and to shrink during diastole, thereby increasing atrial compliance.

[0123] The atrial enhancement balloon device 1100 includes the balloon 1102 (or a membrane) with a sealing structure 1104, such as a sealing clip or sealing ring. The sealing structure 1104 is adapted to seal an opening through the wall of the left atrium 2. In some implementations, the sealing structure 1104 is configured to act as a mounting for the balloon 1102. The sealing structure 1104 holds open a hole through the wall of the left atrium 2 for blood flow between the left atrium 2 and the balloon 1102. The balloon 1102 can be configured to have a predetermined compliance and flexible volume. The atrial enhancement balloon device 1100 enhances the compliance of the left atrium 2 by providing an additional volume that can expand and contract responsive to changes in left atrial pressures.

[0124] In some implementations, the atrial enhancement balloon device 1100 can be implanted in a puncture of the left atrial wall using the sealing structure 1104. The sealing structure 1104 can be configured to reduce or eliminate blood leakage through the puncture in the wall of the left atrium 2. The balloon 1102 extends out of the puncture of the left atrial wall to define a compliant volume for blood to effectively increase atrial compliance.

[0125] To implant the atrial enhancement balloon device 1100, a puncture is formed in the left atrial wall. The balloon 1102 (or other flexible membrane) is then passed through the puncture and coupled to the left atrial wall. The balloon 1102 is in fluid communication with the left atrium 2 and extends outwardly from the left atrial wall. The sealing structure 1104 is adapted to couple the balloon 1102 to the atrial wall. In some implementations, the sealing structure 1104 is designed to provide adequate sealing around the opening formed in the atrial wall. The sealing structure 1104 can be any suitable type of sealing clip. To access and puncture the atrial wall, any suitable procedure can be used such as a procedure that uses percutaneous transatrial access to pericardial space.

[0126] Once implanted, the atrial enhancement balloon device 1100 is configured to enhance atrial compliance in the following manner, by way of example. During systole, the increased pressure in the left atrium 2 expands the balloon 1102, thus adding the expanded volume of the balloon 1102 to the volume of the left atrium 2. This results in a pressure drop in the leftatrium 2. During diastole, the lower pressure in the left atrium 2 deflates or shrinks the balloon 1102. The result is that the effective volume of the left atrium 2 returns to be approximately the same as the original volume of the left atrium (e.g., the volume of the left atrium 2 prior to implanting the atrial enhancement balloon device 1100). This is accompanied by a momentary rise in pressure.

[0127] In some implementations, the atrial enhancement balloon device 1100 can extend through the puncture in the left atrial wall into pericardial space. In some implementations, the atrial enhancement balloon device 1100 can assume a relatively flattened or oblong path to fit under the pericardium. That is, the balloon 1102 can assume a flattened or expanded configuration along a plane that can generally conform to the pericardial or myocardial plane.Vessel Compliance Device in the Pulmonary Vein

[0128] FIGS. 12A and 12B illustrate a vessel compliance device 1200 that is configured to add compliance to a section of a pulmonary vein 1205 leading into the left atrium. The vessel compliance device 1200 is thus adapted to add compliance to inhibit or prevent backwards pressure transmission from the left heart to the pulmonary vasculature. The vessel compliance device 1200 includes a stent 1202 deployed in the pulmonary vein 1205. In some implementations, the vessel compliance device 1200 can be deployed close to the pulmonary ostium at the left atrium. The vessel compliance device 1200 includes a squeezable layer 1204 configured to be squeezed under elevated pressure of blood flowing through an inner lumen 1206 defined by the squeezable layer1204. The vessel compliance device 1200 is thus configured to increase compliance of the section of the pulmonary vein 1205 next to the left atrium. It should be understood that the vessel compliance device 1200 can be deployed in any suitable vessel to increase compliance of the vessel and / or chambers of the heart near the vessel in which the vessel compliance device 1200 is deployed.

[0129] The stent 1202 can be anchored against the inner wall 1210 of the pulmonary vein1205. In some implementations, the vessel compliance device 1200 increases or stretches an inner diameter of the inner wall 1210 of the pulmonary vein 1205. The stent 1202 is covered by a squeezable cylindrical wall, forming the squeezable layer 1204, that defines the inner lumen 1206 through which blood can flow. The squeezable layer 1204 is configured to change the size (e.g., diameter) of the inner lumen 1206 defined thereby (through which blood flows into the left atrium). The squeezable layer 1204 changes between a squeezed state, in which the inner walls of the squeezable layer 1204 are pushed radially outwards under elevated internal pressure, and an unsqueezed state in which the inner walls of the squeezable layer 1204 can return to their free state (moving radially inwards), thereby increasing and decreasing the diameter of the inner lumen 1206through which the blood flows, so as to increase venous compliance at the section leading to the left atrium. In some embodiments, the squeezable layer 1204 can be filled with a compressible gas. In some embodiments, the squeezable layer 1204 can be filled with a material that can change its phase between gas and liquid due to changes in luminal pressure at body temperature.

[0130] FIGS. 12C and 12D illustrate an example vessel compliance device 1220 wherein a stent 1222 includes a squeezable layer 1224 that comprises a double- walled layer that contains a fluid (a gas or liquid) configured to move via a thin tube 1228 connected to a chamber 1230 at a separate location. In some implementations, the chamber 1230 is implanted within the same vessel that the stent 1222 is anchored. In such implementations, high blood pressure inside of an inner lumen 1226 defined by the squeezable layer 1224 squeezes the squeezable layer 1224 by forcing the fluid to flow through the thin tube 1228 to the chamber 1230. Pressure applied by the chamber 1230 is adapted to force the fluid to flow therefrom back towards the squeezable layer 1224 to reexpand the squeezable layer 1224, responsive to blood pressure inside of the inner lumen 1206 dropping to lower values. In some implementations, more than one compliance device can be placed in more than one pulmonary vein branched from the left atrium.Atrial Enhancement Balloon Extending from the Left Atrial Appendage

[0131] FIG. 13 illustrates an example of an atrial enhancement balloon device 1300 that extends from the LAA 1320. Similar to the atrial enhancement balloon device 1100 described herein with reference to FIG. 11, the atrial enhancement balloon device 1300 is configured to enhance compliance of the left atrium 2. The atrial enhancement balloon device 1300 includes a balloon 1302 or other such flexible membrane. The balloon 1302 provides an expandable volume that is adapted to inflate during systole to add available volume to the left atrium 2 and to shrink during diastole, thereby increasing atrial compliance.

[0132] The atrial enhancement balloon device 1300 is adapted to be act as an appendage replacement, or to effectively replace the LAA 1320 with the balloon 1302. The balloon 1302 is implanted at a location where the LAA 1320 is punctured so that the balloon 1302 extends out of the LAA 1320, the balloon 1302 being mounted via a sealing structure 1304, such as a sealing clip or sealing ring.

[0133] FIGS. 14A, 14B, 14C, and 14D illustrate stages of a method of puncturing the LAA 1320 and mounting the atrial enhancement balloon device 1300. FIG. 14A illustrates a transeptal catheter 1350 advanced into the left atrium 2 and towards the LAA 1320. The transeptal catheter 1350 implants the sealing structure 1304 at the opening of the LAA 1320. In addition, a valve 1306 (e.g., a temporary valve and / or a unidirectional valve) is mounted inside the sealing structure 1304.

[0134] FIG. 14B illustrates that the transeptal catheter 1350 then applies suction to the LAA 1320. This moves the distal end wall of the LAA 1320 closer to the transeptal catheter 1350 (or a suction catheter that is part of the transeptal catheter 1350). The valve 1306 is adapted to ensure that suction is limited to the volume of the LAA 1320.

[0135] FIG. 14C illustrates that with the wall of the LAA 1320 in close proximity to the opening of the LAA 1320, an ablation catheter 1352 is advanced through the valve 1306 to puncture the wall of the LAA 1320. FIG. 14D illustrates that after puncturing the wall of the LAA 1320, the balloon 1302 is mounted such that the balloon 1302 extends outwards from the LAA 1320, serving to increase LA compliance in a similar manner to the atrial enhancement balloon device 1100 described herein with reference to FIG. 11. In some implementations, after implanting the balloon 1302 and the sealing structure 1304, the valve 1306 can be retrieved along with the rest of the puncturing delivery system (e.g., the transeptal catheter 1350).

[0136] Once implanted, the atrial enhancement balloon device 1300 is configured to enhance atrial compliance in the following manner, by way of example. During systole, the increased pressure in the left atrium 2 expands the balloon 1302, thus adding the expanded volume of the balloon 1302 to the volume of the left atrium 2. This results in a pressure drop in the left atrium 2. During diastole, the lower pressure in the left atrium 2 deflates or shrinks the balloon 1302. The result is that the effective volume of the left atrium 2 returns to be approximately the same as the original volume of the left atrium (e.g., the volume of the left atrium 2 prior to implanting the atrial enhancement balloon device 1100). This is accompanied by a momentary rise in pressure.

[0137] In some implementations, the atrial enhancement balloon device 1300 can extend through the puncture in the LAA wall into pericardial space. In some implementations, the atrial enhancement balloon device 1300 can assume a relatively flattened or oblong path to fit under the pericardium. That is, the balloon 1302 can assume a flattened or expanded configuration along a plane that can generally conform to the pericardial or myocardial plane.Additional Features and Embodiments|0138| The present disclosure provides methods and devices (including various medical implants) for addressing elevated left-sided filling pressures to mitigate the effects of diastolic dysfunction. The term “implant” is used herein according to its plain and / ordinary meaning and may refer to any medical implant, frame, valve, shunt, stent, anchor, and / or similar devices for use in treating various conditions in a human body. Implants may be delivered via catheter (i.e., transcatheter) for various medical procedures and may have a generally sturdy and / or flexible structure. The term “catheter” is used herein according to its broad and / ordinary meaning and mayinclude any tube, sheath, steerable sheath, steerable catheters, and / or any other type of elongate tubular delivery device comprising an inner lumen configured to slidably receive instrumentation, such as for positioning within an atrium or coronary sinus, including for example delivery catheters and / or cannulas. Some transcatheter processes described herein can utilize a single catheter or multiple catheters.

[0139] Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0140] The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0141] The above description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed above. While specific embodiments, and examples, are described above for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while processes or blocks are presented in a given order, alternative embodiments may perform routines having steps, or employ systems having blocks, in a different order, and some processes or blocks may be deleted, moved, added, subdivided, combined, and / ormodified. Each of these processes or blocks may be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks may instead be performed in parallel or may be performed at different times.

[0142] Certain terms of location are used herein with respect to the various disclosed embodiments. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe a spatial relationship of one device / element or anatomical structure relative to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s) / structures(s), as illustrated in the drawings. Spatially relative terms are intended to encompass different orientations of the element(s) / structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element / structure described as “above” another element / structure may represent a position that is below or beside such other element / structure with respect to alternate orientations of the subject patient or element / structure, and vice-versa.

[0143] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment.

[0144] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited. In some contexts, description of an operation or event as occurring or being performed “based on,” or “based at least in part on,” a stated event or condition can be interpreted as being triggered by or performed in response to the stated event or condition.

[0145] With respect to the various methods and processes disclosed herein, although certain orders of operations or steps are illustrated and / or described, it should be understood that the various steps and operations shown and described may be performed in any suitable or desirable temporal order. Furthermore, any of the illustrated and / or described operations or steps may be omitted from any given method or process, and the illustrated / described methods and processes may include additional operations or steps not explicitly illustrated or described.

[0146] It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above but should be determined only by a fair reading of the claims that follow.

[0147] Unless the context clearly requires otherwise, throughout the description and the claims, the terms “comprise,” “comprising,” “have,” “having,” “include,” “including,” and the like are to be construed in an open and inclusive sense, as opposed to a closed, exclusive, or exhaustive sense; that is to say, in the sense of “including, but not limited to.”

[0148] The word “coupled”, as generally used herein, refers to two or more elements that may be physically, mechanically, and / or electrically connected or otherwise associated, whether directly or indirectly (e.g., via one or more intermediate elements, components, and / or devices. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole, including any disclosure incorporated by reference, and not to any particular portions of the present disclosure. Where the context permits, words in present disclosure using the singular or plural number may also include the plural or singular number, respectively.

[0149] The word “or” in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, as used herein, the term “and / or” used between elements (e.g., between the last two of a list of elements) means any one or more of the referenced / related elements. For example, the phrase “A, B, and / or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C,” or “A, B, and C.”

[0150] As may be used herein, the terms “substantially” and “approximately” provides an industry- accepted tolerance for its corresponding term and / or relativity between items. For some industries, an industry-accepted tolerance is less than one percent, while for other industries, the industry- accepted tolerance may be 10 percent or more. Other examples of industry-accepted tolerances range from less than one percent to fifty percent. Industry-accepted tolerances correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise and fall times, thermal noise, dimensions, signaling errors, dropped packets, temperatures, pressures, material compositions, and / or performance metrics. Within an industry, tolerance variances of accepted tolerances may be more or less than a percentage level (e.g., dimension tolerance of less than approximately + / - 1%). Some relativity between items may range from a difference of less than a percentage level to a few percent. Other relativity between items may range from a difference of a few percent to magnitude of differences.

[0151] One or more embodiments have been described above with the aid of method steps illustrating the performance of specified functions and relationships thereof. The boundaries and sequence of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternate boundaries and sequences can be defined so long as the specified functions and relationships are appropriately performed. Any such alternate boundaries or sequences are thus within the scope and spirit of the claims. Further, the boundaries of these functional building blocks have been arbitrarily defined for convenience of description. Alternate boundaries could be defined as long as the certain significant functions are appropriately performed. Similarly, flow diagram blocks may also have been arbitrarily defined herein to illustrate certain significant functionality.

[0152] To the extent used, the flow diagram block boundaries and sequence could have been defined otherwise and still perform the certain significant functionality. Such alternate definitions of both functional building blocks and flow diagram blocks and sequences are thus within the scope and spirit of the claims. One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.

[0153] The one or more embodiments are used herein to illustrate one or more aspects, one or more features, one or more concepts, and / or one or more examples. A physical embodiment of an apparatus, an article of manufacture, a machine, and / or of a process may include one or more of the aspects, features, concepts, examples, etc. described with reference to one or more of the embodiments discussed herein. Further, from figure to figure, the embodiments may incorporate the same or similarly named functions, steps, modules, etc. that may use the same, related, orunrelated reference numbers. The relevant features, elements, functions, operations, modules, etc. may be the same or similar functions or may be unrelated.

Claims

WHAT IS CLAIMED IS:

1. A vessel compliance device for implanting in a vessel of a patient to increase compliance of the vessel, the vessel compliance device comprising: a stent adapted to be anchored to a wall of a vessel; a squeezable layer covering the stent and forming an inner lumen through the stent to provide a flow path for blood through the vessel compliance device, the squeezable layer adapted to change size responsive to changes in blood pressure in the vessel, wherein the squeezable layer changes between a squeezed state and an un-squeezed state, wherein the squeezed state occurs where inner walls of the squeezable layer are pushed radially outwards under elevated blood pressure, thereby increasing an inner diameter of the inner lumen, wherein the un-squeezed state occurs where the inner walls of the squeezable layer move radially inwards responsive to a decrease in blood pressure from the elevated blood pressure, thereby decreasing the inner diameter of the inner lumen.

2. The vessel compliance device of claim 1, wherein the vessel compliance device is adapted to be anchored against an inner wall of a pulmonary vein close to a pulmonary ostium of a left atrium.

3. The vessel compliance device of claim 2, wherein the stent increases an inner diameter of the inner wall of the pulmonary vein.

4. The vessel compliance device of claim 1, wherein the squeezable layer is filled with a gas.

5. The vessel compliance device of claim 1, wherein the squeezable layer is filled with a liquid.

6. The vessel compliance device of claim 1, wherein the squeezable layer is filled with a material that changes phase between gas and liquid due to changes in luminal pressure.

7. The vessel compliance device of claim 1, wherein the squeezable layer comprises a squeezable cylindrical wall that covers the stent.

8. The vessel compliance device of claim 1 further comprising:a tube coupled to the squeezable layer, the tube adapted to convey fluid to and from the tube; and a container apart from the stent and coupled to the tube, wherein the squeezable layer contains a fluid that moves between the container and the squeezable layer responsive to changes in pressure in blood flowing through the inner lumen.

9. The vessel compliance device of claim 8, wherein the squeezable layer comprises a double-walled layer that contains the fluid.

10. The vessel compliance device of claim 8, wherein in the squeezed state, fluid is forced from the squeezable layer through the tube to the container.

11. The vessel compliance device of claim 10, wherein in the un-squeezed state, fluid flows from the container to the squeezable layer via the tube.

12. The vessel compliance device of claim 11, wherein fluid is forced out of the container in the un-squeezed state by pressure applied by the container.

13. The vessel compliance device of claim 8, wherein the container is adapted to be implanted outside of the vessel within which the stent is anchored.

14. The vessel compliance device of claim 8, wherein the container is adapted to be implanted within the vessel within which the stent is anchored.

15. The vessel compliance device of claim 8, wherein the fluid comprises a liquid.

16. A device for enhancing atrial compliance, the device comprising: an anchor structure adapted to be anchored in the interatrial septum between the left atrium and the right atrium; and a deformable membrane coupled to the anchor structure.

17. The device of claim 16, wherein the anchor structure comprises an annular seal adapted to be anchored within a hole in the interatrial septum between the left atrium and the right atrium.

18. The device of claim 17, wherein the deformable membrane comprises an inner compliant membrane coupled to the annular seal to seal the hole in the interatrial septum.

19. The device of claim 18, wherein the deformable membrane is adapted to respond to a threshold pressure such that responsive to pressure in the left atrium exceeding the threshold pressure, the inner compliant membrane adapted to deform into the right atrium to increase effective volume in the left atrium to enhance atrial compliance.

20. The device of claim 19, wherein responsive to pressure in the left atrium being at or below the threshold pressure, the inner compliant membrane is adapted to be flush with the interatrial septum.

21. The device of claim 18, wherein the inner compliant membrane is adapted to be compliant in both directions so that the inner compliant membrane is adapted to bulge into the right atrium and into the left atrium.

22. The device of claim 18, wherein the inner compliant membrane is adapted to be stiff in one direction and compliant in another direction so that the inner compliant membrane is adapted to bulge into the right atrium and to not bulge into the left atrium.

23. The device of claim 16, wherein the anchor structure comprises a frame adapted to anchor to the interatrial septum.

24. The device of claim 23, wherein the deformable membrane comprises a deformable diaphragm coupled to the frame, the deformable diaphragm adapted to fill and to empty responsive to pressures in the right atrium.

25. The device of claim 24, wherein the deformable diaphragm is adapted to fill with deoxygenated blood from the right atrium responsive to a pressure gradient between right atrial pressure and left atrial pressure exceeding a threshold value.

26. The device of claim 25, wherein the deformable diaphragm is adapted to empty to become flush with the septum responsive to the pressure gradient being less than the threshold value.

27. The device of claim 25, wherein the deformable diaphragm is adapted to bulge into the left atrium responsive to the pressure gradient exceeding the threshold value.

28. The device of claim 25, wherein the deformable diaphragm is adapted to bulge into the right atrium responsive to the pressure gradient being less than the threshold value.

29. An atrial enhancement balloon device adapted to enhance atrial compliance in a left atrium of a heart of a patient, the atrial enhancement balloon device comprising:a sealing structure adapted to hold open and seal a puncture through tissue, the puncture providing a blood flow path out of the left atrium and out of the heart; and a flexible membrane mounted to the sealing structure to receive blood through the puncture through the tissue, the flexible membrane adapted to receive blood from the left atrium and to expand and contract responsive to changes in pressure in the left atrium; wherein, responsive to elevated pressure in the left atrium, blood flows through the sealing structure into the flexible membrane, thereby increasing a volume of the flexible membrane, wherein, responsive to a decrease in pressure in the left atrium, the volume of the flexible membrane decreases and pushes blood through the sealing structure into the left atrium.

30. The atrial enhancement balloon device of claim 29, wherein the flexible membrane is adapted to assume a flattened configuration to conform to a pericardial plane to fit under a pericardium of the heart.

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