Method and apparatus for performing a procedure on a cardiac valve

Abstract

The present invention comprises a method for deploying an aortic valve prosthesis. This valve prosthesis may include any of the known aortic valves including, but not limited to, stented and unstented bioprosthetic valves, stented mechanical valves, and expandable or self-expanding valves, whether biological or artificial. The method involves the steps of: making a first opening leading to the left atrium; passing a valve prosthesis through the opening and into a cardiac chamber of the left side of the heart using a first manipulation instrument; making a second opening in the arterial system and advancing one end of a second manipulation instrument through the arterial opening and into the aforementioned cardiac chamber; securing the second manipulation instrument to the valve prosthesis; and using the second manipulation instrument to retract at least some portion of the valve prosthesis out of the aforementioned cardiac chamber.

1 . A method of inserting a prosthesis or device from a lower pressure region into a higher pressure region of the cardiovascular system comprising the steps of: 
 making an opening in a wall of a lower pressure region of the cardiovascular system;    advancing the prosthesis or device through the opening and into the lower pressure region; and    advancing the prosthesis or device through a natural barrier between the lower pressure region and the higher pressure region.    
   
   
       2 . The method of  claim 1  wherein the lower pressure region comprises at least one from the group consisting of the left atrium, the right atrium, a pulmonary vein, the pulmonary artery, and the venous system.  
   
   
       3 . The method of  claim 1  wherein the higher pressure region comprises at least one from the group consisting of the left ventricle, the right ventricle and the arterial system.  
   
   
       4 . The method of  claim 1  wherein the natural barrier comprises at least one of the group consisting of a valve, a wall between chambers of the heart, and the venous system.  
   
   
       5 . The method of  claim 4  wherein the valve is a cardiac valve.  
   
   
       6 . The method of  claim 5  wherein the cardiac valve is an atrioventricular valve.  
   
   
       7 . The method of  claim 6  wherein the cardiac valve is the mitral valve.  
   
   
       8 . The method of  claim 6  wherein the cardiac valve is the tricuspid valve.  
   
   
       9 . The method of  claim 5  wherein the cardiac valve is the aortic valve.  
   
   
       10 . The method of  claim 5  wherein the cardiac valve is the pulmonic valve.  
   
   
       11 . The method of  claim 4  wherein the wall between chambers of the heart comprises at least one from the group consisting of the interatrial septum and the interventricular septum.  
   
   
       12 . A method of inserting a prosthesis or device into a vessel within the arterial system comprising the steps of: 
 making an opening in a wall of a low pressure region of the heart;    advancing the prosthesis or device through the opening and into the low pressure region;    advancing the prosthesis or device through a natural barrier between the low pressure region and the left ventricle; and    advancing the prosthesis or device from the left ventricle into the arterial system and the vessel.    
   
   
       13 . The method of  claim 12  wherein the natural barrier comprises at least one from the group consisting of the mitral valve and the interatrial septum.  
   
   
       14 . The method of  claim 12  wherein the wall is the external wall of the left atrium, and the natural barrier is the mitral valve.  
   
   
       15 . The method of  claim 12  wherein the wall is the wall of the right atrium, and the natural barrier is the interatrial septum and the mitral valve.  
   
   
       16 . A method of inserting a prosthesis or device into a vessel within the arterial system comprising the steps of: 
 making an opening in a wall of the left atrium;    advancing the prosthesis or device through the opening and into the left atrium;    advancing the prosthesis or device through the mitral valve and into the left ventricle; and    advancing the prosthesis or device from the left ventricle into the arterial system and the vessel.    
   
   
       17 . The method of  claim 16  further comprising the use of first and second manipulation instruments for advancing the prosthesis or device, wherein: 
 the first manipulation instrument is used to advance the prosthesis or device through the opening, into the left atrium, through the mitral valve and into the left ventricle; and    the second manipulation instrument, passing through a second incision into the arterial system and advanced into the left ventricle, is used to advance the prosthesis or device from the left ventricle into the arterial system and the vessel.    
   
   
       18 . The method of  claim 16  wherein the prosthesis or device is an aortic valve prosthesis.  
   
   
       19 . The method of  claim 16  wherein the vessel is the aorta.  
   
   
       20 . The method of  claim 16  further comprising the use of a manipulation instrument capable of advancing the prosthesis or device and articulating in a region near the attachment site of the manipulation instrument to the prosthesis or device, wherein the manipulation instrument is used to advance the prosthesis or device into the left ventricle and is then articulated at said region in order to allow advancement of the prosthesis or device into the arterial system.  
   
   
       21 . A method of inserting a prosthesis or device into a vessel within the arterial system comprising the steps of: 
 making an opening in a pulmonary vein;    advancing the prosthesis or device through the opening into the left atrium;    advancing the prosthesis or device through the mitral valve and into the left ventricle; and    advancing the prosthesis or device from the left ventricle into the arterial system and to the vessel.    
   
   
       22 . A method of inserting a prosthesis or device into a vessel within the arterial system comprising the steps of: 
 making an opening into the right atrium;    advancing the prosthesis through this incision;    making an opening in the interatrial septum;    advancing the prosthesis through this opening in the interatrial septum;    advancing the prosthesis or device through the opening into the left atrium;    advancing the prosthesis or device through the mitral valve and into the left ventricle; and    advancing the prosthesis or device from the left ventricle into the arterial system and to the vessel.    
   
   
       23 . A method for inserting a prosthesis or device into a vessel within the arterial system comprising the steps of: 
 inserting a manipulation instrument into the left ventricle;    advancing the manipulation instrument through the mitral valve and into the left atrium;    attaching the prosthesis or device onto the manipulation instrument; and    withdrawing the manipulation instrument out of the left atrium, across the mitral valve and into the left ventricle.    
   
   
       24 . The method of  claim 16  wherein the prosthesis or device is releasably attached to a prosthesis holding apparatus as the prosthesis or device is advanced through the left atrium and the left ventricle to the vessel.  
   
   
       25 . The method of  claim 16  wherein the prosthesis holding apparatus and the attached prosthesis are advanced by means of a manipulation instrument to which the prosthesis holding apparatus is releasably attached.  
   
   
       26 . An apparatus for deploying an arterial prosthesis comprising: 
 a flexible holder having means for engaging and supporting an arterial prosthesis; and    at least one mount projecting from said holder in position to be releasably engaged by a manipulation instrument.    
   
   
       27 . An apparatus according to  claim 26  wherein said holder has two mounts projecting therefrom at different angles relative to said prosthesis.  
   
   
       28 . An apparatus according to  claim 26  wherein said holder has a substantially conical shape.  
   
   
       29 . An arterial prothesis assembly for deploying an arterial prosthesis for implantation in an arterial vessel, said assembly comprising: 
 an arterial prosthesis adapted for implantation in a vessel within an arterial system; and    a holder having means for releasably engaging and supporting said arterial prosthesis, and at least one mount for attachment to a manipulation instrument, said mount projecting outwardly from said holder.    
   
   
       30 . An arterial prosthesis assembly according to  claim 29  wherein said holder has two mounts for attachment to a manipulation instrument, said mounts projecting outwardly from said holder at different angles relative to said prosthesis.  
   
   
       31 . An arterial prosthesis assembly according to  claim 30  wherein said prosthesis is an arterial valve prosthesis.  
   
   
       32 . An arterial prosthesis assembly according to  claim 31  wherein said prosthesis is an aortic valve prosthesis.  
   
   
       33 . An arterial prosthesis assembly to  claim 29  wherein said prosthesis has a flow orifice, and said mount is aligned with said orifice.  
   
   
       34 . An arterial prosthesis assembly according to  claim 29  wherein said mount comprises a spherical termination.  
   
   
       35 . An arterial prosthesis assembly according to  claim 34  wherein said holder comprises a hollow conically-shaped body with an open end, and said prosthesis is attached to said holder at said open end.  
   
   
       36 . An arterial prosthesis assembly for deploying an arterial prosthesis for implantation in an arterial vessel, said assembly comprising: 
 an arterial prosthesis adapted for implantation in a vessel within an arterial system, said prosthesis comprising an annular portion defining an orifice; and    a holder having first and second means for releasably supporting said arterial prosthesis, said first means releasably engaging said annular portion on a first side of said orifice and said second means extending through said orifice and releasably engaging said annular portion on a second side of said orifice, whereby said first and second means exert opposing forces on said annular portion to prevent movement of said prosthesis relative to said holder.    
   
   
       37 . An assembly according to  claim 36  wherein each of said first and second means engage said annular portion at a plurality of circumferentially spaced points.  
   
   
       38 . An assembly according to  claim 36  wherein said holder comprises a central portion and said first means comprises a plurality of arms pivotally attached to said central portion.  
   
   
       39 . An assembly according to  claim 38  wherein said arms are pivotable between a first retracted position in which they extend substantially parallel to the center axis of said central portion and a second expanded position in which they extend at an acute angle to said central portion.  
   
   
       40 . An assembly according to  claim 39  wherein said arms have first ends pivotally connected to said central portion and second ends that are adapted to engage said annular portion of said prosthesis.  
   
   
       41 . An assembly according to  claim 40  wherein said second means comprises a plurality of spring fingers having curved outer ends that engage said annular portion of said prosthesis.  
   
   
       42 . A holder for an arterial prosthesis comprising: 
 a hollow center member having first and second opposite ends;    a plurality of supporting arms mutually spaced about the center axis of said center member, said arms having inner and outer ends and being pivotally attached to said center member adjacent said first end of said center member so that said arms can pivot between a first retracted position in which said outer ends lie close to said center member and a second extended position in which said outer ends are spaced from said center member;    an actuating shaft having first and second opposite ends, said actuating shaft being slidably disposed within said center member and movable between first and second limit positions relative to said center member;    means acting between said actuating shaft and said inner ends of said arms for causing said arms to pivot to said first retracted position from said second extended position when said actuating shaft is moved from its second limit position to its first limit position and for causing said arms to pivot to said second extended position from said first retracted position when said actuating shaft is moved from its said first limit position to its said second limit position; and    a plurality of spring fingers mutually spaced about the center axis of said center member, said fingers each having first and second ends, with said first ends attached to said actuating shaft and said second ends projecting beyond the said first end of said center member, said second ends of said spring fingers being curved outwardly from said center axis of said center member, whereby said outer ends of said arms and said second ends of said spring fingers can coact to grip a prosthesis.    
   
   
       43 . A holder according to  claim 42  further including means for biasing said spring fingers so as to move said second ends of said spring fingers inwardly toward said center axis of said center member when said actuating shaft is moved to its first limit position.  
   
   
       44 . The method of  claim 1  wherein a filament is positioned in the left atrium, advanced across the mitral valve, and advanced across the left ventricle and into the arterial system and the vessel, and further wherein the prosthesis or device is advanced along the filament from the left atrium to the vessel.  
   
   
       45 . The method of  claim 1  wherein a tube is positioned in the left atrium, advanced across the mitral valve, and advanced across the left ventricle and into the arterial system and the vessel, and further wherein the prosthesis or device is advanced within the tube from the left atrium to the vessel.  
   
   
       46 . A system for deploying an arterial prosthesis comprising: 
 a first manipulation instrument for attachment to the arterial prosthesis;    a second manipulation instrument for attachment to the arterial prosthesis; and    a guide for directing the second manipulation instrument to the arterial prosthesis when the arterial prosthesis is attached to the first manipulation instrument, said guide comprising a first mount for mounting said first manipulation instrument to said guide, and a second mount for mounting said second manipulation instrument to said guide, said second mount being configured relative to said first mount so as to direct said second manipulation instrument at the arterial prosthesis when the arterial prosthesis is held by said first manipulation instrument and said first manipulation instrument is mounted to said first mount.