Transcatheter aortic valvuloplasty device

Abstract

A valvuloplasty device comprises an expandable anchor and an expansion member mounted about an outer surface of the expandable anchor. The expansion member is either an annular balloon or a sleeve. The valvuloplasty device can be used for valvuloplasty and for valve implantation.

1 . A valvuloplasty device comprising:
 an expandable anchor having a proximal end, a distal end, an outer surface extending between the proximal end and the distal end, and an inner surface extending between the proximal end and the distal end, the inner surface defining a lumen; and   an expansion member selected from the group consisting of:
 an annular expandable balloon having an inner surface and an outer surface, the annular balloon disposed around the outer surface of the expandable anchor such that the inner surface of the balloon directly contacts the outer surface of the expandable anchor; and 
 a sleeve disposed around the outer surface of the expandable anchor. 
   
     
     
         2 . The valvuloplasty device of  claim 1 , wherein the expansion member is affixed to at least one location on the outer surface of the anchor. 
     
     
         3 . The valvuloplasty device of  claim 2 , wherein the distal end of expansion member is affixed to the distal end of the anchor. 
     
     
         4 . The valvuloplasty device of  claim 1 , wherein the expansion member extends axially over at least a portion of the anchor. 
     
     
         5 . The valvuloplasty device of  claim 1 , wherein the valvuloplasty device has:
 a delivery configuration wherein the anchor is in a delivery state and the expansion member is in a delivery state;   a deployed configuration, wherein the anchor is in an deployed state and the expansion member is in the deployed state.   
     
     
         6 . The valvuloplasty device of  claim 5 , wherein the expansion member is the sleeve, the sleeve in the delivery state having a smooth outer surface and a smooth inner surface, and the sleeve in the deployed state having a corrugated outer surface and a corrugated inner surface. 
     
     
         7 . The valvulplasty device of  claim 5 , wherein the expansion member is the balloon, the balloon being inflatable, the balloon in the delivery state being uninflated, the balloon in the deployed state being inflated. 
     
     
         8 . The valvuloplasty device of  claim 7 , the valvuloplasty device further having a partially deployed configuration wherein the anchor is in the deployed state and the balloon is in the delivery state. 
     
     
         9 . The valvuloplasty device of  claim 7 , wherein the balloon has a plurality of folds when the expandable anchor is in the delivery state. 
     
     
         10 . The valvuloplasty device of  claim 7 , wherein the balloon has a plurality of spines engaged to an inner wall of the balloon, the plurality of spines being positioned about a circumference of the inner wall of the balloon. 
     
     
         11 . A method for a valvuloplasty device,
 the valvuloplasty device comprising:
 an expandable anchor having a proximal end, a distal end, an outer surface extending between the proximal end and the distal end, and an inner surface extending between the proximal end and the distal end, the inner surface defining a lumen; and 
 an expansion member selected from the group consisting of:
 an annular expandable balloon having an inner surface and an outer surface, the annular balloon disposed around the outer surface of the expandable anchor such that the inner surface of the balloon directly contacts the outer surface of the expandable anchor; and 
 a sleeve disposed around the outer surface of the expandable anchor; 
 
   the method comprising expanding the valvuloplasty device at a deployment location wherein the valvuloplasty device is expanded from a delivery configuration to a deployed configuration.   
     
     
         12 . The method of  claim 11 , wherein the expansion member is the balloon, the method further comprising:
 expanding the anchor from a delivery state to a deployed state so that the valvuloplasty device is in a partially deployed configuration; and   then expanding the balloon from a delivery state to a deployed state so that the valvuloplasty device is in a deployed configuration.   
     
     
         13 . The method of  claim 11 , wherein the expansion member is the sleeve, the sleeve having an outer surface and an inner surface, wherein when the anchor is in the delivery state the sleeve has a smooth outer surface and a smooth inner surface, and when the anchor is in the deployed state the sleeve has a corrugated outer surface and a corrugated inner surface. 
     
     
         14 . The method of  claim 11 , wherein only a distal end of the expansion member is affixed to the expansion member. 
     
     
         15 . The method of  claim 11 , wherein the expansion member is the annular balloon, the annular balloon being detachably connected to a detachable inflation mechanism in fluid communication with a fluid source. 
     
     
         16 . The method of  claim 11 , further comprising retrieving the valvuloplasty device from the lumen. 
     
     
         17 . The method of  claim 11 , the valvuloplasty device being delivered to the deployment location by a delivery device, the delivery device comprising:
 a tubular sheath, the tubular sheath defining a lumen, the valvuloplasty device being positioned within the lumen of the tubular sheath in the delivery configuration.   
     
     
         18 . The method of  claim 17 , the tubular sheath having a flared distal end. 
     
     
         19 . The method of  claim 17 , the delivery device further comprising a control mechanism comprising at least one suture line or at least one wire woven through an opening extending between the outer surface of the anchor to an inner surface of the anchor, wherein the control mechanism is configured to retrieve the valvuloplasty device. 
     
     
         20 . The method of  claim 17 , the anchor further comprising an inner surface defining an anchor lumen, the method further comprising deploying a replacement valve within the anchor lumen.