Abstract: A delivery apparatus can include a handle portion and at least one rotatable drive shaft. The handle portion can have an actuation mechanism with a motor. The rotatable drive shaft can have a proximal end portion and a distal end portion. The proximal end portion of the rotatable drive shaft can be coupled to the motor, and the distal end portion of the rotatable drive shaft can be configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism can be configured to control and monitor expansion of the prosthetic heart valve and to control and monitor torque of the motor.

Abstract: A method of delivering a percutaneous heart valve is disclosed. The percutaneous heart valve includes an expandable frame having a plurality of cells and a valve seated inside the expandable frame. The heart valve also includes a proximal anchoring portion and a distal anchoring portion having a plurality of distal anchors. After expansion, the proximal anchoring portion extends distally and a portion of each distal anchor extends proximally. A portion of each distal anchor is positioned radially outwardly from the frame and extends in a direction that is substantially parallel with the longitudinal axis. Proximal portions of the distal anchors are preferably spaced apart by less than two cell lengths from a distal portion of the proximal anchoring portion. During deployment, radial expansion of the frame draws the proximal anchoring portion and the distal anchors into closer proximity with body tissue positioned therebetween.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

Abstract: A method for delivering a heart valve prosthesis to a native valve annulus comprises expanding an expandable frame at the native valve annulus and positioning a replacement heart valve within the expandable frame. The expandable frame preferably includes a first anchoring portion that is positioned on a first side of the native valve annulus and a second anchoring portion that is positioned on a second side of the native valve annulus. The first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus for securing the expandable frame to the native valve annulus. The replacement heart valve comprises a plurality of leaflets for replacing the function of the native valve.

Abstract: An endoluminal support structure includes strut members interconnected by swivel joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A delivery apparatus comprises a handle portion and at least one rotatable drive shaft. The handle portion has an actuation mechanism and a display. The actuation mechanism includes a motor and one or more actuators. The rotatable drive shaft has a proximal end portion and a distal end portion. The proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve, and the display is configured to display a diameter of the prosthetic heart valve.

Abstract: A mitral valve implant includes a force-expanding mitral valve lattice having an interior orifice and a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice. The mitral valve lattice is self-expandable to a first configuration and force expandable from the first configuration to a second configuration. The configurations can be circular or D-shaped. The mitral valve lattice comprises jack screws adjusting configurations of the mitral valve lattice. The valve trampoline has a cylindrical central region comprising valve leaflets. An outwardly flaring implant skirt is attached to the mitral valve lattice exterior. Wall-retaining wires are attached to the mitral valve lattice, are petal-shaped, and have a pre-set, radially outward, memory shape. The wires and skirt impart a force on a respective side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an annular flap positioned around an exterior of the expandable frame. In some embodiments, the annular flap can extend outward from the frame and have a collapsed configuration and an expanded configuration.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Abstract: A support structure includes strut members interconnected by rotatable joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

Abstract: A valve prosthesis can be configured to be deployed within a native heart valve and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the native heart valve, a flap assembly positioned around an exterior of the expandable frame, a proximal end of the flap assembly being positioned at or proximate a proximal end of the expandable frame. In some embodiments, the flap assembly can extend outward from the frame and have an expanded configuration configured to create a barrier to fluid flow exterior to the frame when deployed within the native heart valve.

Abstract: Embodiments of the present disclosure provide a prosthetic heart valve. The prosthetic heart valve includes an outer frame, an inner frame positioned at least partially within the outer frame, and an occluder member positioned at least partially within the inner frame. The prosthetic heart valve also includes an atrial flange extending from an atrial end of the outer frame, and a ventricular flange extending from a ventricular end of the outer frame, wherein at least a portion of the atrial flange extends radially outward beyond the ventricular flange.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Abstract: A percutaneous heart valve for deployment within a body cavity is described. The percutaneous heart valve includes an expandable frame having a plurality of cells adapted for allowing the frame to expand and collapse. A one-way valve is positioned within the expandable frame. The frame includes a proximal anchoring portion and a distal anchoring portion. The distal anchoring portion includes a plurality of distal anchors, each distal anchor having at least a portion positioned radially outwardly from the frame and extending in a direction that is substantially parallel with a longitudinal axis. The distal anchors preferably bend radially outwardly before bending to extend toward the proximal anchoring portion. Radial expansion of the frame causes the proximal and distal anchoring portions to move closer together for capturing body tissue therebetween, thereby anchoring the percutaneous heart valve to the body tissue.

Abstract: A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus. The prosthetic heart valve has a plurality of pivotably connected struts and one or more adjustable elements rotatably coupled to the struts. Rotating the adjustable elements in a first direction relative to the struts radially expands the prosthetic heart valve. Rotating the adjustable elements in a second direction relative to the struts radially contracts the prosthetic heart valve. The delivery apparatus includes one or more motors, one or more drive wires coupled to the motors, and a memory. The drive wires are coupled to the adjustable elements of the prosthetic heart valve. The motors are configured to rotate the drive wires and the adjustable elements to expand and contract the prosthetic heart valve. The memory is configured for storing one or more characteristics of the motors, the drive wires, or the prosthetic heart valve.

Abstract: A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.