A prosthetic heart valve includes a valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the prosthetic heart valve to be delivered to a heart of a patient via a delivery catheter. The valve frame is configured to transition to an expanded configuration when released from the delivery catheter. The prosthetic heart valve is configured to be seated in a native annulus when the valve frame is in the expanded configuration. The distal and proximal anchoring elements configured to be inserted through the native annulus prior to seating the prosthetic heart valve. The proximal anchoring element is ready to be deployed subannularly or is optionally configured to be transitioned from a first configuration to a second configuration after the prosthetic valve is seated.

A collapsible-expandable tubular stent (29) constructed of shape-memory material which is implantable into a human heart, which comprises proximal and distal rings (71, 73) and at least two spaced apart posts (69) that extend axially between said rings (71, 73), said distal ring (73) comprising a plurality of distal arms (77) which are connected to the distal ring (73) at only one end and which have a free opposite end; said proximal ring (71) comprising a plurality of, which are connected at only one end to the proximal ring (71) and which have a free opposite end, which proximal arms (75) are constructed to swing radially outward at their free ends.

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.

The invention relates to a connector device and a method for loading a prosthesis onto a delivery system as well as a method for delivery of the prosthesis and optionally retrieval of the prosthesis.

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable prosthesis frame. If desired, one or more expandable anchors may be used. The prosthesis frame, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the prosthesis frame may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia. The prosthesis frame is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthesis frame expands to an expanded position such that the valve and prosthesis frame expand at the implantation site and the anchor engages the lumen wall. The prosthesis frame has a non-cylindrical configuration with a preset maximum expansion diameter region about the valve opening to maintain the preferred valve geometry. The prosthesis frame may also have other regions having a preset maximum expansion diameter to avoid blockage of adjacent structures such as the coronary ostia.

The present invention provides methods and apparatus for endovascularly replacing a patient's heart valve. The apparatus includes a replacement valve and an expandable anchor configured for endovascular delivery to a vicinity of the patient's heart valve. In some embodiments, the replacement valve is adapted to wrap about the anchor, for example, by everting during endovascular deployment. In some embodiments, the replacement valve is not connected to expandable portions of the anchor. In some embodiments, the anchor is configured for active foreshortening during endovascular deployment. In some embodiments, the anchor includes expandable lip and skirt regions for engaging the patient's heart valve during deployment. In some embodiments, the anchor comprises a braid fabricated from a single strand of wire. In some embodiments, the apparatus includes a lock configured to maintain anchor expansion. The invention also includes methods for endovascularly replacing a patient's heart valve. In some embodiments, the method includes the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve, wrapping at least a portion of the replacement valve about the anchor, and expanding the anchor to a deployed, configuration.

Improved catheter devices for delivery, repositioning and/or percutaneous retrieval of percutaneously implanted heart valves are described, including a medical device handle that provides an array of features helpful in conducting a percutaneous heart valve implantation procedure while variously enabling radial expansion or contraction and/or lateral positioning control over the heart valve during the medical procedure.

A medical device system may include a delivery device including an outer sheath and an inner shaft having a coupler fixed to a distal end of the inner shaft, and a replacement heart valve implant releasably attached to the coupler, the replacement heart valve implant including an expandable anchor member and a plurality of locking mechanisms configured to engage with the coupler. The delivery device may include a plurality of collars configured to secure the coupler to the plurality of locking mechanisms. The delivery device may include a stop element configured to selectively prevent disengagement of the plurality of collars from the plurality of locking mechanisms.

A rod (508) is transfemorally advanceable to the heart. An implant (460) comprises (i) a first frame (462), compressed around a first longitudinal site of a distal portion of the rod, (ii) a second frame (464), compressed around a third longitudinal site of the distal portion, (iii) a valve member (50), disposed within the second frame, and (iv) a flexible sheet (466), coupling the first frame to the second frame, and disposed around a second longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site. An extracorporeal controller (569) is coupled to a proximal portion of the rod, and is operably coupled to the distal portion of the rod. Operating the controller bends the distal portion of the rod causing articulation between the frames. Other embodiments are also described.

Methods, devices and systems for anchoring and/or sealing a heart valve prosthesis and, in particular, a mitral valve prosthesis (202). Inflatable elements (204, 206) are used to seal and anchor the mitral valve prosthesis (202) and/or other elements associated with repairing a native mitral valve.