Methods and Devices for Delivery of Prosthetic Heart Valves and Other Prosthetics

Abstract

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures. The preferred delivery device includes a catheter having a deployment mechanism attached to its distal end, and a handle mechanism attached to its proximal end. A plurality of tethers are provided to selectively restrain the valve during deployment. A number of mechanisms for active deployment of partially expanded prosthetic valves are also described.

1 . Apparatus for delivering a prosthetic device to a treatment location within a patient by way of the patient's vasculature, comprising:
 a catheter having proximal and distal ends, the distal end of said catheter being adapted to carry a prosthetic device, said prosthetic device having a longitudinal axis, a fully contracted state for delivery to a treatment location, and an expanded state for deployment at the treatment location, and   one or more tethers associated with said distal end of said catheter, said one or more tethers adapted to axially engage and to selectively restrain said prosthetic device.   
   
   
       2 . The apparatus of  claim 1 , wherein said tethers are adapted to selectively restrain said prosthetic device in a partially contracted state different from said fully contracted state. 
   
   
       3 . The apparatus of  claim 2 , wherein said prosthetic device comprises a multi-segment support member having segments that invert to form the partially contracted state. 
   
   
       4 . The apparatus of  claim 3 , wherein said prosthetic device comprises a three-paneled, three-hinged support member, and wherein said partially contracted state comprises a tri-star. 
   
   
       5 . The apparatus of  claim 1 , wherein said tethers are adapted to selectively restrain said prosthetic device in its expanded state. 
   
   
       6 . The apparatus of  claim 1 , further comprising a tubular member carried on the distal end of said catheter and substantially surrounding said prosthetic device, said tubular member provided with a plurality of slots, a portion of said prosthetic device selectively extending through at least one of said plurality of slots when said prosthetic device is in a partially contracted state different from said fully contracted state. 
   
   
       7 . The apparatus of  claim 6 , wherein rotation of said tubular member relative to said prosthetic device causes a portion of said prosthetic device to extend through at least one of said plurality of slots. 
   
   
       8 . The apparatus of  claim 7 , further comprising a control member located on the proximal end of said catheter, said control member configured to cause rotation of said tubular member relative to said prosthetic device. 
   
   
       9 . The apparatus of  claim 8 , wherein said control member is configured to retract said tubular member in a proximal direction relative to said prosthetic device such that the tubular member no longer substantially surrounds said prosthetic device. 
   
   
       10 . The apparatus of  claim 9 , wherein said tethers are adapted to selectively restrain said prosthetic device in said partially contracted state. 
   
   
       11 . The apparatus of  claim 10 , wherein said prosthetic device comprises a multi-segment support member having segments that invert to form the partially contracted state. 
   
   
       12 . The apparatus of  claim 11 , wherein said prosthetic device comprises a three-paneled, three-hinged support member, and wherein said partially contracted state comprises a tri-star. 
   
   
       13 . The apparatus of  claim 6 , further comprising a hub carrying a plurality of wrapping pins extending distally from said hub and being substantially surrounded by said tubular member, wherein said prosthetic device is carried on said wrapping pins when the prosthetic device is in its fully contracted state and its partially contracted state. 
   
   
       14 . The apparatus of  claim 13 , wherein said prosthetic device is transformed from its fully contracted state to its partially contracted state by relative rotation between said tubular member and said hub carrying a plurality of wrapping pins. 
   
   
       15 . The apparatus of  claim 13 , further comprising a control member located on the proximal end of said catheter, said control member configured to cause rotation of said tubular member relative to said prosthetic device. 
   
   
       16 . The apparatus of  claim 15 , wherein said control member is configured to retract said tubular member in a proximal direction relative to said prosthetic device such that the tubular member no longer substantially surrounds said prosthetic device, and further wherein said control member is configured to independently retract said plurality of wrapping pins in a proximal direction relative to said prosthetic device such that the prosthetic device is no longer carried on said wrapping pins. 
   
   
       17 . The apparatus of  claim 16 , wherein said tethers are adapted to selectively restrain said prosthetic device in said partially contracted state when said plurality of wrapping pins are retracted. 
   
   
       18 . The apparatus of  claim 17 , wherein said prosthetic device comprises a multi-segment support member having segments that invert to form the partially contracted state. 
   
   
       19 . The apparatus of  claim 18 , wherein said prosthetic device comprises a three-paneled, three-hinged support member, and wherein said partially contracted state comprises a tri-star. 
   
   
       20 . The apparatus of  claim 1 , further comprising a deployment member adapted to convert the prosthetic device to its fully expanded state after the prosthetic device has been disengaged from the catheter. 
   
   
       21 . The apparatus of  claim 20 , wherein said deployment member comprises a first movable member adapted to movably engage a shaft portion of said catheter, and a radially expandable member that is able to be selectively expanded radially by moving said movable member along said shaft portion. 
   
   
       22 . The apparatus of  claim 21 , wherein said radially expandable member is caused to expand when said movable member moves distally along said shaft portion. 
   
   
       23 . The apparatus of  claim 20 , wherein said deployment member comprises an inflatable member that is selectively located internally of said prosthetic device such that inflation of said inflatable member causes said prosthetic device to transition to its fully expanded state. 
   
   
       24 . The apparatus of  claim 23 , wherein said deployment member comprises a plurality of inflatable members. 
   
   
       25 . The apparatus of  claim 23 , wherein said inflatable member comprises a balloon having at least two portions having different radial dimensions. 
   
   
       26 . The apparatus of  claim 20 , wherein said deployment member comprises an inflatable member that is selectively attached externally of said prosthetic device such that inflation of said inflatable member causes said prosthetic device to transition to its fully expanded state. 
   
   
       27 . The apparatus of  claim 20 , wherein said deployment member comprises a roller that engages an interior surface of said prosthetic device, and a pincher that engages an external surface of said prosthetic device. 
   
   
       28 . The apparatus of  claim 20 , wherein said deployment member comprises a separator that engages an internal surface of said prosthetic device, and a guide member that engages an external surface of said prosthetic device. 
   
   
       29 . The apparatus of  claim 20 , wherein said deployment member comprises a torsional spring attached to a hinge formed on said prosthetic device.