Methods and devices for repair or replacement of heart valves or adjacent tissue without the need for full cardiopulmonary support

Abstract

Methods and systems for endovascular, endocardiac, or endoluminal approaches to a patient's heart to perform surgical procedures that may be performed or used without requiring extracorporeal cardiopulmonary bypass. Furthermore, these procedures can be performed through a relatively small number of small incisions. These procedures may illustratively include heart valve implantation, heart valve repair, resection of a diseased heart valve, replacement of a heart valve, repair of a ventricular aneurysm, repair of an arrhythmia, repair of an aortic dissection, etc. Such minimally invasive procedures are preferably performed transapically (i.e., through the heart muscle at its left or right ventricular apex).

1 - 45 . (canceled) 
     
     
         46 . A heart valve having a longitudinal axis, the valve comprising a self-expanding stent that includes a curved tissue-engaging peak that curves away from the longitudinal axis. 
     
     
         47 . The valve of  claim 46  wherein the self-expanding stent defines:
 a first circumference in a first plane perpendicular to the longitudinal axis; 
 a second circumference in a second plane perpendicular to the longitudinal axis; and 
 a third circumference in a third plane perpendicular to the longitudinal axis; 
 
       wherein:
 the second circumference is between the first and third circumferences; 
 the first and third circumferences are greater than the second circumference; and 
 the tissue-engaging peak is part of the third circumference. 
 
     
     
         48 . The valve of  claim 47  wherein the first, second and third circumferences, together, are configured to conform to a native valve rim to secure the valve against dislodgement from the native valve rim. 
     
     
         49 . The valve of  claim 47  further comprising a securement element that is supported by the self-expanding stent, the securement element providing security against dislodgement, from heart tissue, of the self-expanding stent. 
     
     
         50 . The valve of  claim 49  wherein the securement element is a hook. 
     
     
         51 . The valve of  claim 49  wherein the securement element is configured to bite into an aortic rim. 
     
     
         52 . The valve of  claim 49  wherein the securement element is configured to bite into an aortic wall. 
     
     
         53 . The valve of  claim 49  wherein the securement element is configured to grasp an aortic rim. 
     
     
         54 . The valve of  claim 49  wherein the securement element is configured to grasp an aortic wall. 
     
     
         55 . The valve of  claim 46  wherein the self-expanding stent includes a sinusoidal structure. 
     
     
         56 . The valve of  claim 46  wherein the self-expanding stent is configured to exert radial expansion forces that are strong enough to secure the valve against dislodgment. 
     
     
         57 . The valve of  claim 46  wherein the peak is included in a plurality of peaks, the plurality including proximal peaks and distal peaks. 
     
     
         58 . The valve of  claim 57  wherein the proximal peaks and distal peaks are configured to engage a native valve annulus. 
     
     
         59 . The valve of  claim 58  wherein the proximal peaks and the distal peaks are pointed or sharpened. 
     
     
         60 . The valve of  claim 46  wherein the peak is a distal peak and is configured to engage an aortic wall. 
     
     
         61 . The valve of  claim 46  further comprising a distal mounting ring supported distal to the peak by distal ends of commissure supports, the distal mounting ring corresponding to an aortic wall extending from an aortic sino-tubular junction. 
     
     
         62 . The valve of  claim 46  further comprising a stent-like support structure supported distal to the peak by distal ends of commissure supports and corresponding to an aortic wall extending from an aortic sino-tubular junction. 
     
     
         63 . The valve of  claim 62  wherein the stent-like support structure is configured to support a distal end of the valve such that the valve is supported against the aortic wall at a location distal to coronary sinuses. 
     
     
         64 . The valve of  claim 46  wherein the self-expanding stent includes a bulge that corresponds to a natural curvature below an aortic sino-tubular junction, the bulge providing securement against dislodgement of the valve relative to the curvature. 
     
     
         65 . The valve of  claim 64  wherein the bulge mimics the natural curvature. 
     
     
         66 . The valve of  claim 64  further comprising a commissure support that has a portion that is included in the bulge. 
     
     
         67 . The valve of  claim 46  further comprising valve leaflets, wherein the stent includes a stent frame that includes commissure supports configured to support the valve leaflets. 
     
     
         68 . The valve of  claim 46  further comprising attachment points designated for attachment to corresponding retraction devices. 
     
     
         69 . The valve of  claim 68  wherein the attachment points are designated for attachment to corresponding retraction wires. 
     
     
         70 . The valve of  claim 46  wherein the self-expanding stent is configured to be mechanically attached to a delivery device. 
     
     
         71 . The valve of  claim 46  wherein the self-expanding stent is compressible. 
     
     
         72 . The valve of  claim 46  further comprising commissure supports that are configured to support, distal to the peak, valve leaflets. 
     
     
         73 . The valve of  claim 46  wherein the self-expanding stent comprises a shape-memory material. 
     
     
         74 . The valve of  claim 46  wherein the peak is a proximal peak and is configured to engage a native valve annulus. 
     
     
         75 . The valve of  claim 46  wherein the peak is included in a plurality of peaks, the plurality including proximal peaks. 
     
     
         76 . The valve of  claim 46  wherein the peak is included in a plurality of peaks, the plurality including distal peaks. 
     
     
         77 . The valve of  claim 47  wherein the second and third circumferences, together, are configured to conform to a native valve rim to secure the valve against dislodgement from the native valve rim. 
     
     
         78 . The valve of  claim 77  wherein the first circumference is configured to be deployed distal to an aortic sino-tubular junction. 
     
     
         79 . The valve of  claim 77  wherein the first circumference is configured to be deployed at an aortic sino-tubular junction. 
     
     
         80 . The valve of  claim 47  wherein the third circumference is configured to conform to a native valve rim to secure the valve against dislodgement from the native valve rim. 
     
     
         81 . The valve of  claim 80  wherein the first circumference is configured to be deployed distal to an aortic sino-tubular junction. 
     
     
         82 . The valve of  claim 80  wherein the first circumference is configured to be deployed at an aortic sino-tubular junction. 
     
     
         83 . The valve of  claim 64  wherein the bulge is configured to conform to the natural curvature.