Method for delivering a surgical heart valve

Inventors

Conklin, Brian S.

Assignees

Edwards Lifesciences Corp

Abstract

Valve holders and introducers for delivering a prosthetic heart valve to an implant site are configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient's body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, such as a handle that prevents implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate temporary deformation of a nitinol prosthetic valve to pass between adjacent ribs of a patient without rib spreading. Valves are provided having a wireform and stiffener band made of materials that exhibit superelastic properties. Valve holders, introducers, and valves according to the various embodiments can be used in minimally invasive procedures, such as thoracotomy procedures.

Core Innovation

The disclosed invention provides a method for delivering a surgical prosthetic heart valve to a native annulus via a thoracotomy. The prosthetic heart valve is prepared for delivery having an undeformed circular shape looking along a central axis, and includes a superelastic flexible frame with commissure posts extending distally from a proximal/inflow end and flexible leaflets forming occluding surfaces for one-way blood flow. The proximal/inflow end is detachably coupled to a valve holder connectable to a delivery handle so that the heart valve points distally from the handle.

An access pathway to the native annulus is created by forming a thoracotomy incision between adjacent ribs. A valve introducer funnel is positioned within the thoracotomy incision, with a proximal end having a circular cross-sectional shape sized to receive the heart valve in an undeformed configuration and a smaller distal end having an oval cross-sectional shape corresponding to the size and shape of the thoracotomy incision. The introducer funnel includes a smooth transition zone connecting the proximal and distal ends substantially free from corners.

The heart valve and valve holder are inserted into the proximal end using the handle and then pushed toward the smaller distal end so the heart valve elastically deforms and squeezes through the oval cross-sectional shape past the adjacent ribs before returning to the undeformed circular shape. The handle is then advanced to deliver the heart valve and valve holder to the native annulus for implantation therein. The documented material further frames this delivery approach as addressing implantation errors by reducing suture looping and preventing implantation until proper handle attachment and alignment.

Claims Coverage

The independent claim coverage is directed to delivering a surgical prosthetic heart valve to a native annulus via a thoracotomy using an introducer funnel with a circular proximal end and an oval distal end that elastically deforms the valve and then allows return to an undeformed circular shape for advancement to the native annulus. The dependent claim set refines this method with additional structural and dimensional limits and, in at least one dependency, adds commissure-post and suture-management mechanics and a cloth-covered sewing ring.

Overall claim coverage centers on delivery of a superelastic prosthetic heart valve through a thoracotomy by using an introducer funnel whose oval distal cross-section forces elastic deformation past adjacent ribs, followed by return toward an undeformed circular shape for advancement to the native annulus. Dependent claims further specify rib-spacing and incision length, the major and minor diameters of the oval distal funnel, funnel material, mitigation of suture looping through radially inward commissure-post flex in a delivery position, and mitral valve delivery into the left atrium.

Stated Advantages

Documented Applications