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 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 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.

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.

A catheter system may include a steering catheter and a steering cable extending through a lumen in the wall of the steering catheter. A steering assembly may include a spool assembly having an outer spool, an inner spool received within the outer spool, and a spool shaft received within the inner spool. The spool shaft and a recess of the inner spool may be shaped so that rotation of the spool shaft causes rotation of the inner spool. The inner spool may include splines that engage with complementary recesses of the inner spool, such that the outer spool is prevented from rotating relative to the inner spool. The steering cable may be fixed to the outer spool and may be configured to be wound around the spool assembly upon rotation of the outer spool about the longitudinal axis of the spool shaft.

An intravascular device delivery system has an elongated member with a flexible hypotube. The hypotube can be rotationally keyed to a steerable catheter. The flexible hypotube includes one or more cuts to allow bending of the flexible hypotube within a first plane. The steerable catheter is steerable to bend the flexible hypotube within the first plane, and longitudinally movable relative to the flexible hypotube to allow distal movement of the steerable catheter relative to a distal end of the flexible hypotube.

A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

A delivery system for delivering an implantable medical device, such as a prosthetic heart valve, intravascularly to a target site, such as a heart valve annulus in a patient. The system includes a catheter assembly consisting of a plurality of concentrically arranged catheters positioned within an outer sheath and a handle assembly that includes a plurality of controls that selectively translate the catheters relative to one another to deploy the medical device from the outer sheath. An optional inflatable balloon on the catheter assembly helps to visualize the position of the medical device prior to deployment. The delivery system accommodates both the deployment of the medical device as well as re-sheathing should that become necessary.