Percutaneous transvalvular intrannular band for mitral valve repair

Abstract

Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

1 . A method of delivering a transvalvular intraannular implant, comprising:
 providing a delivery catheter, the delivery catheter comprising an elongate body; a movable outer sheath; and a transvalvular intraannular implant having a longitudinal axis from a first end to a second end and comprising a valve leaflet support portion and an anchoring portion, the valve leaflet support portion at least partially longitudinally offset from the anchoring portion;   percutaneously delivering the delivery catheter to the vicinity of a heart valve annulus;   transforming the implant from a first radially reduced configuration to a second radially enlarged configuration; and   positioning the implant in its second radially enlarged configuration within the heart valve annulus such that the implant is oriented in the valve annulus such that the longitudinal axis of the implant is oriented substantially transversely to a coaptive edge of a heart valve positioned within the valve annulus.   
   
   
       2 . The method of  claim 1 , wherein the heart valve annulus is the mitral valve annulus. 
   
   
       3 . The method of  claim 1 , wherein the heart valve annulus is the aortic valve annulus. 
   
   
       4 . The method of  claim 1 , wherein transforming the implant from the first radially reduced configuration to the second radially enlarged configuration comprises retracting the movable outer sheath of the delivery catheter, exposing the implant. 
   
   
       5 . The method of  claim 1 , wherein the delivery catheter further comprises a self-expandable support structure operably connected to the transvalvular implant. 
   
   
       6 . The method of  claim 5 , wherein the expandable support structure comprises a stent. 
   
   
       7 . The method of  claim 1 , wherein percutaneously delivering the delivery catheter to the vicinity of the valve annulus comprises approaching the valve annulus from a supraannular location. 
   
   
       8 . The method of  claim 1 , wherein percutaneously delivering the delivery catheter to the vicinity of the valve annulus comprises approaching the valve annulus from an infraannular location. 
   
   
       9 . The method of  claim 1 , wherein percutaneously delivering the delivery catheter to the vicinity of the valve annulus comprises passing the delivery catheter through the cardiac septum. 
   
   
       10 . The method of  claim 9 , wherein percutaneously delivering the delivery catheter to the vicinity of the valve annulus comprises passing the delivery catheter through the intra-atrial septum. 
   
   
       11 . The method of  claim 1 , wherein percutaneously delivering the delivery catheter to the vicinity of the valve annulus comprises a vascular cut-down. 
   
   
       12 . The method of  claim 1 , wherein percutaneously delivering the delivery catheter to the vicinity of the valve annulus comprises passing a thoracoscope through a chest cavity incision, and passing the delivery catheter through the chest cavity incision into a blood vessel. 
   
   
       13 . The method of  claim 1 , further comprising securing the anchoring portion of the implant to tissue of the valve annulus. 
   
   
       14 . The method of  claim 1 , wherein securing the anchoring portion of the implant to tissue of the valve annulus comprises passing a tissue anchor through the anchoring portion of the implant and tissue of the valve annulus. 
   
   
       15 . The method of  claim 1 , wherein providing a delivery catheter comprises providing a control wire operably attached to the implant, and wherein positioning the implant comprises applying tension to the control wire to move the implant. 
   
   
       16 . The method  claim 15 , further comprising detaching the control wire from the implant. 
   
   
       17 . A transvalvular intraannular delivery system, comprising:
 a percutaneous delivery catheter comprising an elongate body;   a movable outer sheath; and   a transvalvular intraannular implant having a longitudinal axis from a first end to a second end and comprising a valve leaflet support portion and an anchoring portion, the valve leaflet support portion at least partially longitudinally offset from the anchoring portion, wherein the transvalvular implant is configured to be transformable from a first radially reduced configuration to a second radially enlarged configuration; wherein the transvalvular implant is configured to be housed within the percutaneous delivery catheter in its first radially reduced configuration, wherein the transvalvular implant is configured to be positioned in its second radially enlarged configuration within a heart valve annulus such that the implant is oriented in the valve annulus such that the longitudinal axis of the implant is oriented substantially transversely to a coaptive edge of a heart valve positioned within the valve annulus.   
   
   
       18 . The system of  claim 17 , further comprising a control wire operably attached to the implant for positioning the implant within the heart valve annulus. 
   
   
       19 . The system of  claim 17 , further comprising at least one tissue anchor for attaching the implant to tissue of the valve annulus. 
   
   
       20 . The system of  claim 17 , further comprising a self-expandable support structure operably connected to the transvalvular implant, for securing the implant to tissue of the valve annulus.