Stent-valves for valve replacement and associated methods and systems for surgery

Abstract

Stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.

1 - 9 . (canceled) 
     
     
         10 . An apparatus comprising:
 a stent-valve comprising a valve component and a stent component, wherein the stent component includes a first section, a second section configured to house the valve component, and a third section comprising at least one attachment element, and wherein the stent component and the valve component are configured with a collapsed configuration for delivery and an expanded configuration after implantation, and   a delivery system comprising a stent holder to which the at least one attachment element of the stent-valve is removably attachable and an outer sheath,   wherein in a closed position the outer sheath encompasses the stent-valve still attached to the stent holder and thus constrains expansion of the stent-valve,   wherein the sheath and the stent holder are configured for relative movement with respect to one another in order to transition from the closed position, to a partially open position, to an open position,   wherein in the partially-open position, the stent-valve expands partially but does not detach from the stent holder because the outer sheath still encompasses the at least one attachment element of the stent-valve and the stent holder, while in the open position the outer sheath does not constrain expansion of the stent-valve and thus the stent-valve detaches from the stent holder and expands to the expanded configuration,   wherein the stent-valve is returnable from the partially expanded configuration to the collapsed configuration within a patient's body, by sliding the outer sheath over the first section of the stent component to recapture the stent-valve within the outer sheath, and   wherein the stent-valve is automatically detachable from the delivery system by moving the outer sheath clear of the attachment element and the stent holder.   
     
     
         11 . An apparatus comprising:
 a stent-valve comprising a valve component and a stent component, wherein the stent component includes a first section, a second section configured to house the valve component, and a third section comprising at least one attachment element, the stent component and the valve component configured with a collapsed configuration for delivery and an expanded configuration after implantation, and   a delivery system comprising a stent holder to which the at least one attachment element of the stent-valve is removably attachable and an outer sheath,   wherein the outer sheath is positionable over the attachment element and the stent holder so as to maintain the stent-valve in the collapsed configuration and attached to the delivery system,   wherein the outer sheath is partially removable from at least the first section of the stent-valve, and optionally the second section, to allow partial expansion of the stent-valve within a patient's body while the attachment elements of the stent-valve remain constrained by the outer sheath onto the stent holder,   the stent-valve is returnable from the partially expanded configuration to the collapsed configuration within a patient's body, by sliding the outer sheath over the first section of the stent component to recapture the stent-valve within the outer sheath, and   the stent-valve is automatically detachable from the delivery system by moving the outer sheath clear of the attachment element and the stent holder, thereby allowing the stent-valve to self-expand to the expanded configuration.   
     
     
         12 . The apparatus of  claim 10 , wherein the stent valve is fully contained within the outer sheath. 
     
     
         13 . The apparatus of  claim 10 , wherein the outer sheath is a single outer sheath. 
     
     
         14 . The apparatus of  claim 10 , wherein the outer sheath is partially removable from the first and second sections of the stent-valve to allow said partial expansion of the stent-valve while the attachment elements of the stent-valve remain constrained by the outer sheath. 
     
     
         15 . The apparatus of  claim 10 , wherein the partially expanded condition of the stent-valve allows testing of the functionality of the stent valve within the patient's body before finalizing deployment of the stent-valve at the implantation site. 
     
     
         16 . The apparatus of  claim 15 , wherein the stent-valve may be fully recaptured by the delivery device and retrieved from the patient's body if the stent-valve malfunctions during the test, in particular if the valve does not permit sufficient blood-flow. 
     
     
         17 . The apparatus of  claim 10 , wherein the first section is a proximal section, the third section is a distal section, and the second section is disposed axially between the first and third sections. 
     
     
         18 . The apparatus of  claim 10 , wherein the stent component comprises a lattice structure with a plurality of cells. 
     
     
         19 . The apparatus of  claim 18 , wherein all of the cells are closed cells to facilitate recapture of the stent-valve from the partially expanded configuration to the collapsed configuration. 
     
     
         20 . The apparatus of  claim 18 , wherein the first section has a denser population of lattice cells than the second section and/or the third section. 
     
     
         21 . The apparatus of  claim 10 , wherein each attachment element corresponds to all or a portion of a commissural post to which a commissure between two valve leaflets is attached. 
     
     
         22 . The apparatus of  claim 21 , wherein the first, second and third sections comprise a lattice structure with a plurality of cells. 
     
     
         23 . The apparatus of  claim 10 , wherein the first section comprises a fixation element, optionally configured for fixing the stent-component in place at the implantation site. 
     
     
         24 . A method for implanting a stent-valve at an implantation site for cardiac valve replacement, comprising the steps of:
 (a) removably attaching the stent-valve to a delivery device, the stent-valve comprising a valve component and a stent component, the stent component and the valve component configured with a collapsed configuration for delivery and an expanded configuration after implantation;   (b) delivering the stent-valve to the implantation site in the collapsed condition;   (c) partially expanding the stent-valve while maintaining the stent-valve attached to the delivery device;   (d) determining whether the partially expanded stent-valve is positioned correctly at the implantation site;   (e) wherein upon the determination being positive, detaching the stent-valve from the delivery device to cause the stent-valve to expand from the partially expanded configuration to the expanded configuration; and   (f) wherein upon the determination being negative, returning the stent-valve to the collapsed configuration and repositioning the stent-valve at the implantation site.   
     
     
         25 . The method of  claim 24 , wherein the delivery system comprises a stent-holder configured to removably receive at least one attachment element of the stent-valve, and an outer sheath, wherein:
 in a closed position, the outer sheath encompasses the stent-valve attached to the stent holder and constrains expansion of the stent-valve,   the sheath and the stent holder are configured for relative movement with respect to one another in order to transition from the closed position, to a partially-open position, to an open position,   step (b) comprises delivering the stent-valve in the closed position of the delivery system in which the outer sheath encompasses the stent-valve in the collapsed configuration;   step (c) comprises sliding the sheath to transition to the partially-open position in which the stent-valve expands partially but does not detach from the stent-holder because the outer sheath still encompasses the at least one attachment element of the stent-valve, and   step (e) comprises sliding the sheath to transition to the open position in which the outer sheath does not constrain expansion of the stent-valve.   
     
     
         26 . The method of  claim 25 , wherein the step of returning the stent-valve to the collapsed condition comprises sliding the sheath to transition the delivery system from the partially-open position to the closed position to recapture the stent-valve within the outer sheath. 
     
     
         27 . The method of  claim 25 , wherein in the open position, the stent-valve automatically detaches from the stent-holder. 
     
     
         28 . The method of  claim 24 , wherein the step of repositioning includes returning to step (b). 
     
     
         29 . The method of  claim 24 , wherein after returning and repositioning, the method further includes repetition of said partial expansion at the implantation site. 
     
     
         30 . The method of  claim 24 , wherein after the steps of returning and repositioning, the method further comprises releasing the stent-valve at the implantation site. 
     
     
         31 . The method of  claim 24 , wherein determining comprises determining whether the valve component of the partially expanded stent-valve is functioning properly. 
     
     
         32 . The method of  claim 31 , wherein upon determining a negative valve function, the method further comprises the steps of:
 returning the stent-valve to the collapsed configuration, and   removing the stent-valve from a patient's body.   
     
     
         33 . The method of  claim 24 , wherein step (a) comprises accessing a patient's body through an intercostal space and penetrating the left ventricle at the apex of the heart.