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: Disclosed herein are embodiments of a prosthesis and delivery device, as well as methods of use. The delivery device can be composed of an inner retention assembly configured to carry an expandable prosthesis to an in situ target location. The inner retention assembly can slide within an outer elongate hollow member which can cover the expandable prosthesis. The outer elongate hollow member can further be longitudinally collapsed into a receiving member located at the distal end of the outer elongate hollow member.

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 outer skirt positioned annularly around an exterior of the expandable frame. In some embodiments, the outer skirt can extend outward from the frame and be secured to an outwardly extending anchor on the frame to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity.

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 medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

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: Sealable and repositionable implant devices are provided with one or more improvements that increase the ability of implants such as endovascular grafts to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, having adjustable elements, and operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

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: Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

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: Sealable and repositionable implant devices are provided with features that increase the ability of implants such as endovascular grafts and valves to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, the assembly having adjustable elements and being operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

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: 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 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: 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 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: A prosthesis can be deployed within a body cavity. The prosthesis can include an expandable frame, a plurality of proximal prongs, and a plurality of distal prongs. Each prong of the proximal and distal pluralities is connected to the frame. When the frame is expanded, the ends of the prongs are positioned radially outward from the frame. The frame is configured such that radial expansion of the frame causes the ends of the proximal prongs and the ends of the distal prongs to draw closer together.

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: A method is disclosed of enhancing the securing of an intralumenal frame assembly to intralumenal tissue at an in situ target location. The method can comprise delivering an intralumenal frame assembly mounted on a delivery device to a treatment location. The intralumenal frame can be deployed to expand in situ so that anchors on the intralumenal frame atraumatically grasp intralumenal tissue at the target location. A radially inward force can be exerted on the frame assembly to cause the proximal and distal anchors to grasp more forcefully the intralumenal tissue.

Abstract: A prosthesis can be configured to be deployed within a body cavity. The prosthesis has an expandable frame, a plurality of proximal anchors, and a plurality of distal anchors, where the various anchors are connected to the frame. Radial expansion of the frame can cause the ends of the proximal anchors and the ends of the distal anchors to draw closer together.