Prosthetic Mitral Valves And Apparatus And Methods For Delivery Of Same

An apparatus, comprising:

• an outer sheath defining a lumen;
• an inner sheath movably disposed within the lumen of the outer sheath and defining a lumen;
• a tube member movably disposed within the lumen of the outer sheath and defining a lumen;
• a valve holder movably disposed within the lumen of the inner sheath and within a lumen defined by the tube member;
• a prosthetic heart valve disposed at least partially within the lumen of the outer sheath and at least partially within the lumen of the inner sheath,
• the prosthetic heart valve including an outer frame coupled to an inner frame, the inner frame being removably coupled to a distal end portion of the valve holder,
• the outer frame being movable between a first configuration relative to the inner frame and a second configuration relative to the inner frame in which the outer frame is inverted relative to the inner frame, the prosthetic heart valve being disposed within the lumen of the outer sheath and the lumen of the inner sheath with the outer frame in the second configuration;
• a first actuation wire releasably coupled to a first portion of an open free end portion of the outer frame and releasably coupled to the tube member at a first location on the tube member;
• and
• a second actuation wire releasably coupled to a second portion of the open free end portion of the outer frame and releasably coupled to the tube member at a second location on the tube member.

A method, comprising:

• inserting a distal end portion of a delivery sheath into a left atrium of a heart, the delivery sheath having a prosthetic mitral valve disposed within a lumen of the delivery sheath, the prosthetic mitral valve having an outer frame coupled to an inner frame, the outer frame being movable between a first position relative to the inner frame and a second position relative to the inner frame in which the outer frame is inverted relative to the inner frame, the prosthetic mitral valve being disposed within the lumen of the delivery sheath with the outer frame in the second positon relative to the inner frame;
• moving the prosthetic mitral valve distally out of the delivery sheath;
• causing the outer frame of the prosthetic mitral valve to revert back to the first position relative to the inner frame such that the prosthetic mitral valve at least partially assumes a biased expanded configuration;
• and
• positioning the prosthetic mitral valve within a mitral annulus of the heart.