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 . A replacement valve for use within a human body comprising: 
 a valve component; and    a stent component comprising a first section, a second section for housing the valve component, and a third section,    wherein the first section comprises an annular groove.    
   
   
       2 . The replacement valve of  claim 1 , wherein the annular groove is configured to receive and secure circumferentially to an annulus of the valve in need of replacement.  
   
   
       3 . The replacement valve of  claim 1 , further comprising a second stent component comprising an annular projection, wherein the annular projection is configured for matable attachment to the annular groove when the stent component is positioned within the second stent component.  
   
   
       4 . The replacement valve of  claim 1 , wherein the valve component comprises a biological valve.  
   
   
       5 . The replacement valve of  claim 1 , wherein the valve component comprises a synthetic valve.  
   
   
       6 . The replacement valve of  claim 1 , wherein the stent component is self-expandable.  
   
   
       7 . The replacement valve of  claim 1 , wherein the second section of the stent component follows a contour of the valve component.  
   
   
       8 . The replacement valve of  claim 1 , wherein the stent component comprises a lattice structure comprising a plurality of cells, wherein the cells are most densely populated in the first section of the stent-valve.  
   
   
       9 . The replacement valve of  claim 8 , wherein substantially all of the cells of the stent component are closed cells.  
   
   
       10 . The replacement valve of  claim 1 , wherein the annular groove is formed from a plurality of independently bendable elements, wherein each bendable element comprises a bending deformation the location of which is determined by the lengths of an attached pair of struts.  
   
   
       11 . The replacement valve of  claim 1 , wherein the second region comprises at least one locking element protruding outwardly from an outer surface of the second region.  
   
   
       12 . The replacement valve of  claim 11 , wherein the second region comprises a plurality of locking elements that protrude outwardly from the outer surface of the second region and wherein at least two of the plurality of locking elements are positioned at different positions along a central axis of the stent component.  
   
   
       13 . A replacement valve for use within a human body comprising: 
 a valve component;    a stent component comprising a first section, a second section for housing the valve component, and a third section,    wherein the third section comprises at least one attachment element configured for removable attachment to a delivery device.    
   
   
       14 . The replacement valve of  claim 13 , wherein the at least one attachment element comprises a geometric opening configured for removable attachment to a complimentary element of the delivery device.  
   
   
       15 . The replacement valve of  claim 13 , wherein the at least one attachment element comprises a wire, hook, or strap configured for removable attachment to a complimentary element of the delivery device.  
   
   
       16 . The replacement valve of  claim 13 , wherein the at least one attachment element comprises at least two attachment elements.  
   
   
       17 . The replacement valve of  claim 13 , wherein the at least one attachment element comprises at least three attachment elements.  
   
   
       18 . The replacement valve of  claim 13 , wherein the at least one attachment element comprises at least six attachment elements.  
   
   
       19 . The replacement valve of  claim 13 , wherein the stent component comprises a lattice structure comprising: 
 at least one commissural post; and    the at least one attachment element.    
   
   
       20 . The replacement valve of  claim 19 , wherein the lattice structure further comprises at least one supporting element for connecting the at least one commissural post to the at least one attachment element.  
   
   
       21 . The replacement valve of  claim 13 , wherein the at least one attachment element projects at least partially inwardly toward a center axis of the stent component.  
   
   
       22 . The replacement valve of  claim 13 , wherein the third section has a diameter that is less than a diameter of the second section.  
   
   
       23 . A replacement valve for use within a human body comprising: 
 a valve component; and    a stent component comprising: 
 a first section comprising a fixation element;  
 a second section configured to house the valve component; and  
 a third section comprising at least one attachment element.  
   
   
   
       24 . The replacement valve of  claim 23 , wherein the fixation element comprises an annular groove.  
   
   
       25 . The replacement valve of  claim 24 , wherein the annular groove is formed from a plurality of independently bendable elements, wherein each bendable element comprises a bending deformation the location of which is determined by the lengths of an attached pair of struts.  
   
   
       26 . The replacement valve of  claim 23 , wherein the attachment element comprises a wire that forms an opening, hook, or strap.  
   
   
       27 . The replacement valve of  claim 23 , wherein the second region comprises at least one locking element protruding outwardly from an outer surface of the second region.  
   
   
       28 . A replacement valve for use within a human body comprising: 
 a valve component; and    at least two stent components affixed to one another comprising: 
 a first section comprising a first cone or crown and a second stent structure collectively forming a fixation element; and  
 a second section configured to house the valve component.  
   
   
   
       29 . The replacement valve of  claim 28 , wherein the second stent structure comprises a cone or a crown.  
   
   
       30 . The replacement valve of  claim 28 , wherein the second stent structure comprises a plurality of locking elements protruding outwardly from an outer surface of the first section and wherein at least two of the plurality of locking elements are positioned at different vertical positions along a central axis of the first section.  
   
   
       31 . The replacement valve of  claim 28 , wherein: 
 the at least two stent components further comprise a third section comprising at least one attachment element for removable attachment to a delivery device; and    at least one of the first cone or crown and the second cone or crown has cross-section substantially in the shape of a pyramid.    
   
   
       32 . A method for replacing a failed cardiac valve comprising: 
 providing a stent-valve comprising a valve component and a stent component, wherein the stent component comprises an annular groove; and    securing the annular groove axially to an annulus of the valve.    
   
   
       33 . The method of  claim 32 , wherein providing a stent-valve comprises suturing the valve component to the stent component.  
   
   
       34 . The method of  claim 32 , wherein providing a stent-valve comprises expanding the valve component within the stent component in order to form a friction fitting.  
   
   
       35 . The method of  claim 32 , wherein providing a stent-valve comprises securing the valve component to the stent component with a hook-and-loop fastening system.  
   
   
       36 . A method for replacing a worn or diseased cardiac valve comprising: 
 implanting a first stent component comprising an annular element, wherein at least a portion of the stent component is housed within the worn or diseased valve; and    positioning a stent-valve comprising a second stent component and a valve component within the first stent component, wherein the second stent component comprises a complimentary annular element for matably attaching to the first stent component.    
   
   
       37 . A cardiac stent-valve delivery system comprising: 
 a first assembly comprising an outer sheath and a guide wire tubing; and    a second assembly comprising a stent holder configured for removable attachment to at least one attachment element of a stent-valve, the stent-valve positioned over the guide wire tubing of the first assembly,    wherein the first assembly and the second assembly are configured for relative movement with respect to one another in order to transition from a closed position to an open position, such that in the closed position the outer sheath encompasses the stent-valve still attached to the stent holder and thus constrains expansion of the stent-valve, and such that 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 a fully expanded configuration.    
   
   
       38 . The stent-valve delivery system of  claim 37 , wherein the first assembly and the second assembly are configured to transition from the closed position, to a partially-open position, to the open position, wherein in the partially-open position, the stent-valve expands partially proximally 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.  
   
   
       39 . The stent-valve delivery system of  claim 38 , further comprising a flush mechanism.  
   
   
       40 . The stent-valve delivery system of  claim 37 , further comprising at least one balloon configured to cause at least one of valvuloplasty prior to implantation of the stent-valve and expansion or post-dilation of the stent-valve upon inflation of the at least one balloon.  
   
   
       41 . The stent-valve delivery system of  claim 40 , wherein the at least one balloon is housed proximally to the stent-valve.  
   
   
       42 . The stent-valve delivery system of  claim 40 , wherein the at least one balloon is housed distally to the stent-valve.  
   
   
       43 . The stent-valve delivery system of  claim 40 , wherein the at least one balloon is housed at least partially within the stent valve.  
   
   
       44 . The stent-valve delivery system of  claim 37 , further comprising a push handle for causing the relative movement of the first assembly and the second assembly.  
   
   
       45 . The stent-valve delivery system of  claim 37 , further comprising a screw mechanism for translating rotational movement of a handle into the relative movement of the first assembly and the second assembly.  
   
   
       46 . The stent-valve delivery system of  claim 37 , further comprising an integrated introducer within which the first assembly and the second assembly are positioned during delivery of the stent-valve to an implantation site, wherein the integrated introducer is configured to remain within a patient's body even after the first assembly and the second assembly are removed.  
   
   
       47 . The stent-valve delivery system of  claim 37 , wherein after expansion of the stent-valve to the fully expanded configuration, the delivery system is configured to return to the closed position by passing the second assembly through the stent-valve towards a distal end of the first assembly.  
   
   
       48 . The stent-valve delivery system of  claim 37 , wherein the at least one attachment element of the stent-valve comprises a geometrical opening configured for removable attachment to a complimentary structure of the stent holder.  
   
   
       49 . The stent-valve delivery system of  claim 48 , wherein the geometrical opening comprises a circular or ovular opening.  
   
   
       50 . The stent-valve delivery system of  claim 37 , wherein the at least one attachment element of the stent-valve comprises a wire, hook, or strap configured for removable attachment to a complimentary structure of the stent holder.  
   
   
       51 . The stent-valve delivery system of  claim 37 , wherein the at least one attachment element of the stent-valve comprises at least two attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.  
   
   
       52 . The stent-valve delivery system of  claim 37 , wherein the at least one attachment element of the stent-valve comprises at least three attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.  
   
   
       53 . The stent-valve delivery system of  claim 37 , wherein the at least one attachment element of the stent-valve comprises at least six attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.  
   
   
       54 . The stent-valve delivery system of  claim 37 , wherein the stent-valve comprises a lattice structure comprising: 
 at least one commissural post; and    the at least one attachment element.    
   
   
       55 . The stent-valve delivery system of  claim 54 , wherein the lattice structure of the stent-valve further comprises at least one supporting element for connecting the at least one commissural post to the at least one attachment element.  
   
   
       56 . A method for delivering a cardiac stent-valve to an implantation site comprising: 
 removably attaching the stent-valve to a delivery device;    delivering the stent-valve to the implantation site in a collapsed configuration;    partially proximally expanding the stent-valve while maintaining the stent-valve attached to the delivery device; and    making a determination with respect to the stent-valve when the stent-valve is in the partially-expanded configuration.    
   
   
       57 . The method of  claim 56 , wherein the making a determination comprises determining whether the stent-valve is positioned correctly at the implantation site.  
   
   
       58 . The method of  claim 57 , further comprising returning the stent-valve to the collapsed configuration and repositioning the stent-valve when the stent-valve is not positioned correctly at the implantation site.  
   
   
       59 . The method of  claim 56 , wherein the making a determination comprises determining whether a valve component of the stent-valve is functioning properly.  
   
   
       60 . The method of  claim 59 , wherein determining whether the valve component is functioning properly comprises testing whether the valve component will permit sufficient blood-flow.  
   
   
       61 . The method of  claim 59 , further comprising returning the stent-valve to the collapsed configuration and removing the stent-valve from a patient's body when the stent-valve is not functioning properly.  
   
   
       62 . The method of  claim 56 , further comprising causing the stent-valve to fully expand by causing the stent-valve to detach from the delivery device, when the making a determination yields a positive response.  
   
   
       63 . The method of  claim 56 , wherein the delivering the stent-valve to the implantation site comprises delivering the stent-valve to the heart for replacement of a cardiac valve, wherein the delivering further comprises: 
 accessing a patient's body through an intercostal space; and    penetrating the left ventricle at the apex of the heart.    
   
   
       64 . The method of  claim 63 , wherein the accessing comprises accessing the patient's body through a fifth intercostal space.  
   
   
       65 . An occluder for sealing an orifice in tissue comprising: 
 a first portion capable of expansion from a collapsed configuration on a luminal side of the orifice to an expanded configuration; and    a second portion capable of expansion from a collapsed configuration to an expanded configuration on a side of the orifice opposite to the luminal side,    wherein said first portion and said second portion form a central, hollow channel for housing a guide wire.    
   
   
       66 . The occluder of  claim 65 , further comprising a connector for connecting the occluder to a catheter.  
   
   
       67 . The occluder of  claim 66 , wherein the connector comprises a hollow screw mechanism for connecting the catheter to a threaded catheter.  
   
   
       68 . The occluder of  claim 66 , further comprising a second catheter for housing the occluder for delivery to the tissue orifice.  
   
   
       69 . The occluder of  claim 65 , wherein the first portion of the occluder further comprises a channel sealing mechanism for preventing blood-flow from the luminal side of the tissue orifice.  
   
   
       70 . The occluder of  claim 69 , wherein the channel sealing mechanism comprises at least one of a membrane and foam.  
   
   
       71 . The occluder of  claim 69 , wherein the channel sealing mechanism comprises a valve.  
   
   
       72 . The occluder of  claim 65 , wherein the top portion of the occluder comprises a first material and the bottom portion of the occluder comprises a second material, wherein the second material is coarser than the first material.  
   
   
       73 . A method for sealing an orifice in tissue, comprising: 
 connecting an expandable and collapsible occlusion device to a first catheter, the occlusion device comprising (i) a first portion capable of expansion from a collapsed configuration to an expanded configuration and a second portion capable of expansion from a collapsed configuration to an expanded configuration, (ii) a central channel for housing a guide wire, and (iii) a connector for connecting the occluder device to the first catheter;    inserting the occlusion device into a second catheter in a collapsed condition;    receiving, by the first catheter and central channel, a guide wire;    positioning the second catheter in the orifice, such that a first end of the second catheter is positioned on a luminal side of the orifice; and    causing relative movement between the collapsed occlusion device and the second catheter to move the occlusion device out of the second catheter, wherein upon the occlusion device emerging from the first end of the second catheter, the first portion of the occlusion device expands on the luminal side of the orifice and wherein upon the occlusion device being completely emerged from the second catheter, the second portion expands.    
   
   
       74 . The method of  claim 73 , wherein the tissue orifice comprises a tissue orifice in the left ventricle of the heart, and the positioning the second catheter in the tissue orifice comprises delivering the second catheter to the left ventricle via an intercostal space.