Abstract: Methods and devices that prevent stasis in the LAA by either increasing the flow through the LAA or by closing off or sealing the LAA. Increasing the flow is accomplished through shunts, flow diverters, agitators, or by increasing the size of the ostium. Closing off the LAA is accomplished using seals or by cinching the LAA.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart comprises an expandable frame can comprise a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further comprise a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

Abstract: Devices and methods of treating fluid retention caused by congestive heart failure or other conditions resulting in edema, lymphoedema, or significant fluid retention (e.g., deep vein thrombosis, cellulitis, venous stasis insufficiency, or damage to the lymphatic network) are described. Specifically, a treatment device is used to create a passage or cannula between the lymphatic system (or other area of the body) and an external drainage device. This device can be only temporarily located in the patient or can be implanted within the patient for longer periods of time. The physician can safely and reliably remove excess fluid from the body via the device and optionally inject other treatment agents.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a waist portion that expands to a deployed size having a first diameter, first and second sealing portions extending in opposite directions from the waist portion and expanding radially outward of the waist portion. The first and second sealing portions are sized to seal against first and second portions of the inner surface of the right ventricular outflow tract at the deployed position over a range of sizes of expansion larger than the first diameter. A band is secured to the waist portion of the frame, restricting expansion of the waist portion substantially beyond the first diameter, such that the waist portion is configured to be spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: An expandable stent for implantation in a right ventricular outflow tract includes a frame having a plurality of struts that define a repeating pattern of cells. The repeating pattern of cells comprises a column of exactly three generally diamond shaped cells positioned in end-to-end alignment, and a column of exactly two generally diamond shaped cells positioned in end-to-end alignment. The frame has a substantially hourglass shape with a narrow portion in between a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are configured to expand radially outward to contact a right ventricular outflow tract.

Abstract: In a method of installing an expandable stent in a right ventricular outflow tract, a frame of the expandable stent is positioned at a deployed position in the right ventricular outflow tract, the frame including a waist portion, and first and second opposed sealing portions extending from the waist portion. The frame is expanded such that the waist portion expands to a first diameter, the first sealing portion expands to a second diameter larger than the first diameter and into contact with a first portion of an inner surface of the right ventricular outflow tract, and the second sealing portion expands to a third diameter larger than the first diameter and into contact with a second portion of the inner surface of the right ventricular outflow tract, wherein the waist portion is spaced apart from the inner surface of the right ventricular outflow tract at the deployed position.

Abstract: Renal and urine collection system interventions are provided that improve kidney function by manipulating pressures and/or infusing therapeutic agents in the renal pelvis of the kidney or kidneys. Setting a vacuum and/or infusing therapeutic agents in the renal pelvis results in increased glomerular filtration rate, general solute clearance, and free water excretion via the kidney through the urinary tract and is useful for treatment of CHF, ADHF, AKI, CKD, and many other conditions characterized by fluid overload by reducing fluid buildup. The fluid drawn from the renal pelvis or pelvises is delivered to an external or implanted reservoir or to the bladder using flow manipulation mechanism such as one-way valves, occlusion balloons, multi-lumen catheters, and other mechanisms. Pumps are provided for use in establishing the vacuum pressures that are either manual or motorized.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: Methods and devices that prevent stasis in the LAA by either increasing the flow through the LAA or by closing off or sealing the LAA. Increasing the flow is accomplished through shunts, flow diverters, agitators, or by increasing the size of the ostium. Closing off the LAA is accomplished using seals or by cinching the LAA.

Abstract: An expandable docking station frame includes a waist portion, a sealing portion connected to the waist portion, and a retaining portion connected to the sealing portion. The sealing portion is expandable radially outward of the waist portion to provide a seal against a first location of an inner surface of a circulatory system at a deployed position over a range of sizes of expansion. The retaining portion is expandable radially outward to engage a second location of the inner surface of the circulatory system at the deployed position, to retain the docking station at the deployed position in the circulatory system. When the expandable docking station frame is in an expanded and unconstrained state, the sealing portion and the retaining portion are joined by a concave profile portion radially inward of each of a first outermost diameter of the sealing portion and a second outermost diameter of the retaining portion.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame with a central portion defining a lumen, and first and second opposing end portions. The frame can expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can also have a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member permits a medical instrument to be inserted through the lumen and into the left atrium, for performing a subsequent medical procedure in the left side of the heart.

Abstract: Methods, systems, and apparatuses for treating a heart are provided. Methods can include obtaining and using an implant. One or more catheters can be used to properly position and attach the implant in a desired location in a chamber of the heart, for example, such that (i) a first portion of the implant is anchored to a first site on a wall of the chamber, (ii) a second portion of the implant is anchored to a second site on the wall of the chamber, (iii) a mid-portion of the implant extends in a curved path along the wall of the chamber between the first site and the second site, and (iv) an elongate contraction member of the implant cuts across the chamber between the first site and the second site. Other embodiments are described.

Abstract: A sensor implant device includes a shunt structure comprising a flow path conduit and a plurality of arms configured to secure the shunt structure to a tissue wall, and a pressure sensor device attached to one of the plurality of arms of the shunt structure. The pressure sensor device comprises one or more sensor elements, an antenna, control circuitry electrically coupled to the one or more sensor elements and the antenna, and a housing that houses the control circuitry.

Abstract: Several embodiments of a catheter are described, having a balloon configured to slowly inflate and then quickly deflate to create an area of low pressure in the vessels. The balloon can be cycled near the vessels of the kidneys, thereby helping to draw out blood from the kidneys and enhance fluid processing to the bladder.

Abstract: Disclosed herein are devices and methods for creating a shunt between two vessels or lumens within a patient. While these devices and methods are generally described with regard to treatment of hypertension (e.g., pulmonary arterial hypertension) and/or right heart failure/disfunction, they can be used with a variety of different vessels and lumens for other purposes. The devices include puncturing guidewire embodiments that can more accurately pierce two vessels, as well as snare catheter designs that can prevent unwanted damage from a puncturing guidewire.

Abstract: Expandable docking stations for docking an expandable valve can include a valve seat, one or more sealing portions, and/or one or more retaining portions. The valve seat can be unexpandable or substantially unexpandable beyond a deployed size. The one or more sealing portions can be connected to the valve seat and extend radially outward of the valve seat. The one or more sealing portions can be constructed to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions can be connected to the one or more sealing portions. The one or more retaining portions are configured to retain the docking station at a deployed position.

Abstract: Methods and devices for increasing oxygenation levels in the blood supply and thereby treating the condition of hypoxemia. Multiple approaches such as pressure reduction in the pulmonary circulatory system, reducing triggering mechanisms in the main pulmonary artery and restricting flow in the pulmonary circulatory system are disclosed. Interventions associated with those approaches can including shunting, restrictors, compliance devices, pharmacologic substances, etc.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.