Abstract: A method for delivering a prosthetic valve to a native annulus of a heart can include inserting a delivery apparatus into a patient's body, advancing the delivery apparatus to an implantation location within the native annulus, retracting a delivery sheath of the delivery apparatus relative to the prosthetic valve to expose the prosthetic valve from a distal end of the delivery sheath, and after the prosthetic valve is exposed from the delivery sheath, expanding the prosthetic valve from a radially compressed state to a radially expanded state by reducing axial tension on a first end and a second end of the prosthetic valve.

Abstract: A delivery apparatus for a prosthetic implant can include an elongate first shaft, a first suture guide coupled to the first shaft, an elongate second shaft, and a second suture guide coupled to the second shaft. The first shaft can extend coaxially through the second shaft and the second suture guide, the first suture guide can be disposed distal to the second suture guide, and the first suture guide and the second suture guide can be configured to be axially movable relative to each other.

Abstract: A method for preparing a prosthetic valve and a delivery system for an implantation procedure. The method comprises (a) obtaining a tray, the tray containing the delivery system, the prosthetic valve coupled to the delivery system, and a valve cover in which the prosthetic valve is disposed. The tray comprises a storage cavity comprising an open end, a floor, and a peripheral side wall defining the depth of the cavity, wherein the prosthetic valve and the valve cover are disposed in the storage cavity; and a mounting surface that substantially immobilizes and maintains the valve cover and prosthetic valve within the storage cavity. The method further comprises (b) at least partially filing the storage cavity with a first hydrating fluid to completely immerse the prosthetic valve; and (c) removing the delivery device with the prosthetic valve from the tray, including disengaging the prosthetic valve from the mounting surface.

Abstract: A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system includes a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.

Abstract: A delivery cylinder for a prosthetic implant can include a first tubular portion and a second tubular portion. The second tubular portion has a plurality of strut members coupled to the first tubular portion that define a volume for containing the prosthetic implant in a radially compressed state. The strut members can include respective flex regions configured such that application of force to the strut members causes deformation of the flex regions and corresponding radially inward or outward movement of the strut members relative to a longitudinal axis of the delivery cylinder between an expanded configuration and a contracted configuration.

Abstract: A delivery apparatus for a prosthetic implant can include an elongate first shaft, a first suture guide coupled to the first shaft, an elongate second shaft, and a second suture guide coupled to the second shaft. The first shaft can extend coaxially through the second shaft and the second suture guide, the first suture guide can be disposed distal to the second suture guide, and the first suture guide and the second suture guide can be configured to be axially movable relative to each other.

Abstract: A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system comprises a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.

Abstract: A loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue grasping member attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the tissue grasping member. In an embodiment, the tissue grasping member includes a pair of jaws configured to open to an included angle between the jaws of 180 degrees or more. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.

Abstract: Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another. Once the edges are brought towards one another, they may be joined such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner. Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another.

Abstract: An articulatable, steerable tool guide includes a maneuverable head subassembly, a flexible or rigid insertion tube subassembly, and a handle subassembly. The tool guide defines at least one inner lumen extending through the length of the tool guide, with each such lumen being adapted to receive a flexible endoscopic medical device.

Abstract: Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another. Once the edges are brought towards one another, they may be joined such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner. Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another.

Abstract: Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another. Once the edges are brought towards one another, they may be joined such that a flexible tubular liner is formed having the coated first surface formed as an inner surface of the flexible tubular liner. Flexible tubular liner coating systems are described herein. A method for coating and forming the flexible tubular inner liner may comprise, in one example, coating at least a first surface of a flexible elongate strip having a first and a second edge and then bringing the first and second edges of the flexible elongate strip into proximity of one another.

Abstract: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue grasping member attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the tissue grasping member. In an embodiment, the tissue grasping member includes a pair of jaws configured to open to an included angle between the jaws of 180 degrees or more. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.

Abstract: A tissue grasping apparatus includes a control member, an elongated shaft, and a tissue penetrating and grasping member attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the tissue penetrating and grasping member. In an embodiment, the tissue penetrating and grasping member includes a rigid penetrating member that is rotatably attached to the distal end of the elongated shaft. In an embodiment, the activation mechanism includes a flexible drive wire attached to the penetrating member.