Method and Apparatus Useful for Transcatheter Aortic Valve Implantation

Abstract

A guide catheter ( 30 ) is described for introduction into a patient's vasculature, to provide a substantially continuous guide lumen ( 28 ) within the vasculature to the ascending aorta ( 34 ), through which one or more other functional catheters ( 44 ) may be introduced and removed during the procedure. The guide catheter includes an aligner ( 70 ) at its distal region for aligning the position and/or inclination of the distal region of the guide catheter with respect to the ascending aorta. The aligner includes an embolic protection filter ( 88 ). The guide catheter is made of material collapsible/distensible in cross section to adopt a small shape when no catheter is present inside, and to distend to a large shape to accommodate passage of functional catheter therethrough. The cross-section shape collapses/distends by folding/unfolding of material without elastic stretching of the material.

1 . A flexible guide catheter for use in a transvascular aortic valve replacement procedure, the guide catheter defining a substantially tubular delivery lumen through which one or more other functional catheters may be introduced to the site of the aortic valve, wherein the guide catheter comprises flexible material that permits the lumen of the guide catheter to change shape in at least one of the following ways: (i) to collapse in cross-section to a compact form for introduction into the vasculature, and (ii) to distend in cross-section to a distended form to accommodate the size of said functional catheter introduced therethrough. 
     
     
         2 . The guide catheter of  claim 1 , wherein the wall of the guide catheter comprises sufficient material that the catheter can adopt the distended state without significant stretching of the material. 
     
     
         3 . The guide catheter of  claim 1 , wherein in the compact form, the material is folded. 
     
     
         4 . The guide catheter of  claim 1 , wherein the material of the guide catheter is biased to return towards the compact form after distending to the distended form as said functional catheter passes therethrough. 
     
     
         5 . The guide catheter of  claim 1 , further comprising flexible filaments extending longitudinally within respective wall lumens defined within the wall material of the guide catheter, the flexible filaments being configured to define or actuate an aligner at the distal end region of the guide catheter, the aligner being configured to deform substantially reversibly from a collapsed condition to a deployed condition in response to application of mechanical forces from the proximal end of the guide catheter via the filaments. 
     
     
         6 . (canceled) 
     
     
         7 . A guide catheter for use in a transvascular aortic valve replacement procedure, the guide catheter defining a substantially tubular delivery lumen through which one or more other catheters or devices may be introduced. 
     
     
         8 . The guide catheter of  claim 7 , wherein the guide catheter has a sufficient length to extend from a site of a skin incision, along a vasal route of the vasculature, to a position in the ascending aorta, and
 wherein the guide catheter provides a common guide for the introduction of one or more other catheters or devices therethrough during the procedure, while the guide catheter remains in situ.   
     
     
         9 . (canceled) 
     
     
         10 . The guide catheter of  claim 7 , wherein the guide catheter comprises an aligner operative to align at least a portion of a distal region of the guide catheter with respect to the native vasculature. 
     
     
         11 . The guide catheter of  claim 10 , wherein the aligner comprises one or more elements that, in an operative configuration, are arranged to change shape in at least one of the following ways: (a) to expand towards the wall of the vasculature and (b) to abut the wall of the vasculature. 
     
     
         12 . The guide catheter of  claim 11 , wherein at least one of the elements is selected from: a wire, a filament, a flap, a cantilever, a lattice, a skeletal structure; and a braid. 
     
     
         13 . The guide catheter of  claim 11 , wherein the element is configured to change shape controllably in response to application of stress or strain. 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . The guide catheter of  claim 10 , wherein the aligner is configured to provide controllable alignment of the inclination of the longitudinal axis of the distal region of the guide catheter. 
     
     
         17 . The guide catheter  claim 10 , wherein the aligner is movable to a non-operative configuration in which the aligner is retracted or collapsed towards the guide-catheter. 
     
     
         18 . The guide catheter of  claim 7 , wherein the guide catheter comprises an embolic protection filter that is deployable to capture debris in the blood stream. 
     
     
         19 . The guide catheter of  claim 7 , configured to establish keyed engagement with a device or catheter introduced therethrough, in order to maintain the device/catheter in the same rotational orientation with respect to the guide catheter, while the device/catheter is advanced towards the distal region of the guide catheter. 
     
     
         20 . The guide catheter of  claim 7 , comprising at or near its proximal end, a surrounding sleeve or sheath sealed to the wall of the guide catheter, the sleeve having a generally smooth outer profile, and the guide catheter comprising a catheter wall having a generally non-smooth outer profile (for example, a fluted, pleated or star shape). 
     
     
         21 . The guide catheter of  claim 7 , further comprising, at least initially for introduction into the vasculature and advancement to the ascending aorta, a tapered or rounded tip device at the distal region. 
     
     
         22 . The guide catheter of  claim 21 , wherein the tip is at least one of (a) openable and (b) removable once the guide catheter has been placed in situ in the vasculature. 
     
     
         23 . Apparatus for aligning, within the ascending aorta, a transvascular delivery catheter for delivering a prosthetic valve to an implantation site, the apparatus comprising at least one aligner element movable from a non-operative configuration in which the aligner element does not protrude substantially, to an operative configuration in which the aligner protrudes in at least one of the following ways: (a) outwardly towards the wall of the ascending aorta and (b) abutting, the wall of the ascending aorta. 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . The guide catheter of  claim 3 , wherein in the compact form, the material folds to a configuration comprising at least one selected from: a pleated shape; a fluted shape; an annular shape with S-folds; folds that are asymmetric with respect to a radial direction; and folds that are partially rolled up.