Cephea Valve Technologies, Inc.

A system for heart valve replacement includes a collapsible and expandable replacement heart valve and a packaging assembly for storing the replacement heart valve. The packaging assembly includes a funnel extending from a first end to a second end. The funnel has a first interior diameter at the first end and a second interior diameter, the second interior diameter smaller than the first interior diameter. The funnel defines an internal lumen extending between the first and second ends. The funnel defines a plurality of longitudinal slots extending along an interior surface of the funnel between the first and second ends.

A medical device delivery system includes a steering catheter including a first steering ring having a plurality of apertures positioned in the wall of the first steering ring. The plurality of apertures are positioned at spaced distances around a circumference of the first steering ring. A first steering cable passes through a first one of the apertures, and a first return cable passes through a second one of the apertures. A second steering cable passes through a third one of the apertures, and a second return cable passes through a fourth one of the apertures. The first steering cable is positioned about 180 degrees from the second steering cable. A handle is operably coupled to a proximal end of the steering catheter. A first control member controls the first steering and first return cable, and a second control member controls the second steering and second return cable.

A prosthetic heart valve system includes a collapsible and expandable outer frame extending from an atrial end to a ventricular end, the atrial and ventricular ends coupled by a central portion, the outer frame including a plurality of suture receiving rings formed around a circumference of the ventricular end. The system further includes a collapsible and expandable inner frame positioned radially inward of and coupled to the outer frame. The system further includes a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame, and a strand extending from a first free end to a second free end. A middle portion of the strand passes through each of the suture receiving rings in a delivery configuration of the prosthetic heart valve system. The first and second free ends are configured to be pulled simultaneously by a user to radially collapse the ventricular end of the outer frame.

A prosthetic mitral valve includes a stent frame and an anchor assembly coupled to and peripherally surrounding the stent frame. The anchor assembly includes atrial anchors on the inflow end, ventricular anchors on the outflow end, and a central waist portion disposed therebetween. The anchor assembly generally defines an hourglass shape wherein the atrial and ventricular anchors flare radially outward and the central waist portion has a relatively smaller diameter. The prosthetic valve may include a gasket disposed peripherally around the central waist portion to seal the space between the body of the valve and the native valve annulus to prevent paravalvular leakage without increasing the profile of the valve to allow for smooth insertion into and deployment from a delivery device. The prosthetic valve may alternatively include a sealing fabric surrounding the anchor assembly defining a radial protrusion around the central waist portion to seal the native annulus.

A loading device for crimping a prosthetic heart valve without an internal support member includes a cone having a cone body with a tapering diameter and defining a lumen therethrough and a cone base extending radially from the cone body. The cone base may couple to a funnel also having a tapering diameter and defining a lumen therethrough. The cone may be coupled to the funnel such that the lumen of the cone is aligned with the lumen of the funnel along a longitudinal axis of the loading device. The cone body may define a plurality of slots configured to receive the tines extending from the prosthetic heart valve as the valve is pulled through the loading device and compressed from an expanded state to a collapsed state by the tapering diameter of the cone and the funnel to be disposed inside a delivery device.

A suture rigging assembly for use with a prosthetic heart valve delivery device includes a coupling ring having a plurality of apertures, and at least one tether coupled to the apertures of the coupling ring and extending distally therefrom. Each tether is formed by two lengths of suture thread, the lengths of suture thread joined together at a position spaced from the coupling ring, and a second joining of the lengths of suture thread forming an attachment loop at the distal end of the tether. The first connection in the tethers collectively define the shortest and longest lengths of each of the tethers, and the attachment loops provide a mechanism to releasably attach the tethers to a prosthetic heart valve. Optionally, knots can be used to join the tethers and one or more tethers may include a radiopaque marker secured thereon between two knots.

A medical device delivery system includes a steering catheter including a first steering ring having a plurality of apertures positioned in the wall of the first steering ring. The plurality of apertures are positioned at spaced distances around a circumference of the first steering ring. A first steering cable passes through a first one of the apertures, and a first return cable passes through a second one of the apertures. A second steering cable passes through a third one of the apertures, and a second return cable passes through a fourth one of the apertures. The first steering cable is positioned about 180 degrees from the second steering cable. A handle is operably coupled to a proximal end of the steering catheter. A first control member controls the first steering and first return cable, and a second control member controls the second steering and second return cable.

A prosthetic mitral valve includes a stent frame and an anchor assembly coupled to and peripherally surrounding the stent frame. The anchor assembly includes atrial anchors on the inflow end, ventricular anchors on the outflow end, and a central waist portion disposed therebetween. The anchor assembly generally defines an hourglass shape wherein the atrial and ventricular anchors flare radially outward and the central waist portion has a relatively smaller diameter. The prosthetic valve may include a gasket disposed peripherally around the central waist portion to seal the space between the body of the valve and the native valve annulus to prevent paravalvular leakage without increasing the profile of the valve to allow for smooth insertion into and deployment from a delivery device. The prosthetic valve may alternatively include a sealing fabric surrounding the anchor assembly defining a radial protrusion around the central waist portion to seal the native annulus.

Systems and methods are provided for positioning an intravascular device. A sensing device includes a plurality of nodes disposed on a distal portion of the sensing device. The distal portion of the sensing device is inserted into a circumflex artery. A plurality of node locations of the plurality of nodes are determined in a coordinate system when the distal portion of the sensing device is inserted into the circumflex artery. A projected plane of a mitral annulus is determined in the coordinate system based on the plurality of node locations. A projected deployment point for the intravascular device is determined in the coordinate system based on the plurality of node locations.

An intravascular device delivery system includes an elongated member with a distal end cap and a delivery disc that are longitudinally movable using a disc handle. A main body of the disc handle is configured to move the distal end cap and a movable body of the disc handle is configured to move the delivery disc. The movable body is movable relative to the main body, and the main body and movable body are movable together.