Abstract: In some embodiments, an apparatus includes an introducer sheath and a dilator. The introducer sheath can include a body portion and a tip portion. The body portion can be coupled to the tip portion via a seal portion. The dilator can be configured to be inserted into a lumen defined by the introducer sheath such that the dilator can engage with the tip portion and translate the tip portion relative to the body portion such that the tip portion moves the seal portion from a biased neutral configuration to an extended configuration for delivery of the apparatus to a location in a patient's body. The seal portion can have a larger outermost diameter in the neutral configuration than in the extended configuration.

Abstract: This invention relates to the design and function of a single-tether compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed combats the process of wear on anchoring tethers over time by using a plurality of stent-attached, centering tethers, which are themselves attached to a single anchoring tether, which extends through the ventricle and is anchored to a securing device located on the epicardium.

Abstract: Apparatus and methods are described herein for use in in establishing an improved AV loop with the use of a pulley/snare device at the base of a ventricle of a heart. In some methods described herein, a pulley/snare device is established to create a path with inherent concentricity to the aortic and mitral valves, allowing the valves to function normally during an interventional procedure in the heart, without impeding the motion of any leaflets. The pulley/snare device described herein minimizes the forces that are applied on the valves or associated cardiac tissue to “make the turn” from the aortic valve to the mitral valve.

Abstract: Apparatus and methods are described herein for a secondary valve apparatus that can be deployed within an existing implanted prosthetic heart valve. In some embodiments, a secondary prosthetic heart valve apparatus is implanted in series with an existing deteriorating implanted prosthetic valve. The secondary valve apparatus can restore proper valve function without disruption to the failing previously implanted valve. In some embodiments, the secondary valve apparatus can be positioned on an atrial portion of the existing valve, and be delivered transseptally. In other embodiments, the secondary valve apparatus can be positioned at a ventricular portion of the existing valve and delivered transapically. Devices and methods to prepare the existing valve to receive a secondary valve apparatus are also described herein. In some embodiments, a balloon expansion device can be used to expand an inner diameter of the existing valve to provide space for the secondary valve to be disposed.

Abstract: Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when the valve is in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The distal end portion of the delivery sheath is inserted into a left atrium of a heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. In some embodiments, actuation wires are used to assist in the reversion of the outer frame. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

Abstract: Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when the valve is in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The distal end portion of the delivery sheath is inserted into a left atrium of a heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. In some embodiments, actuation wires are used to assist in the reversion of the outer frame. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve (200) having a body (242) expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchoring tether (191) extending from the prosthetic heart valve can be secured to a wall (Vw) of the heart (H). An electrode (189) coupled to at least one of the prosthetic heart valve or the anchoring tether can then be used to at least one of pace the heart or sense a signal associated with the heart.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Abstract: Apparatus and methods are described herein for various embodiments of a prosthetic heart valve that have a tether securement feature that can be used to secure an anchoring tether to the prosthetic heart valve such that the tether can maintain the prosthetic heart valve in a desired position within the heart under high tensile forces applied to the tether during functioning of the heart. In some embodiments the tether securement feature can also include an engagement member that can be used to help position the prosthetic heart valve within a heart. Such an engagement member can be matingly engaged by a positioning device that can be used to help in radial positioning of the prosthetic heart valve during delivery and deployment of the prosthetic heart valve.

Abstract: A prosthetic heart valve can include an outer frame coupled to an inner frame such that the outer frame can be moved between a first position and a second position in which the outer frame is inverted relative to the inner frame. The inner frame and the outer frame define between them an annular space, and a pocket closure can bound the annular space to form a pocket in which thrombus can form and be retained. The pocket closure can include a stretchable pocket covering that can move from a first position in which the pocket covering has a first length when the outer frame is in the first position relative to the inner frame and a second position in which the pocket covering has a second length greater than the first length when the outer frame is in the second position relative to the inner frame.

Abstract: Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

Abstract: Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Abstract: A prosthetic heart valve can include an outer support assembly, an inner valve assembly, which define between them an annular space, and a pocket closure that bounds the annular space to form a pocket in which thrombus can be formed and retained. Alternatively, or additionally, the outer support assembly and the inner valve assembly can be coupled at the ventricle ends of the outer support assembly and the inner valve assembly, with the outer support assembly being relatively more compliant in hoop compression in a central, annulus portion than at the ventricle end, so that the prosthetic valve can seat securely in the annulus while imposing minimal loads on the inner valve assembly that could degrade the performance of the valve leaflets.

Abstract: Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic heart valve. In some embodiments, an apparatus includes an outer sheath, a tube member movably disposed within the outer sheath, a retention device coupled to the tube member, and a valve holder. A prosthetic heart valve is disposed within the outer sheath and includes an outer frame and an inner frame that is removably coupled to the valve holder. The outer frame is disposed in an inverted configuration relative to the inner frame. A first actuation wire is releasably coupled to a first portion of the outer frame and releasably coupled to the retention device at a first location on the retention device. A second actuation wire is releasably coupled to a second portion of the outer frame and releasably coupled to the retention device at a second location on the retention device.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: In some embodiments, a method for transfemoral retrieval and/or repositioning of a prosthetic valve (400) implanted within a heart includes inserting a retrieval assembly through a femoral vein and into a heart until a distal end portion of the retrieval assembly is disposed in an atrium of the heart. The prosthetic valve is formed with a shape-memory material. The retrieval assembly (402) includes an outer catheter (403), a middle catheter (404), a snare catheter (406), and a snare member (415). The snare member is moved distally out of a lumen of the snare catheter and into engagement with an inner frame (440) of the prosthetic valve. The retrieval assembly can invert an outer frame (410) of the prosthetic valve to collapse and retract the valve into a lumen of the retrieval assembly. In some embodiments, a positioning catheter (419) can be inserted through the apex of the heart to assist in positioning and inverting the prosthetic valve.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: An apparatus for use in the delivery of a prosthetic mitral valve may include an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

Abstract: Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.