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

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 . A method for performing an interventional surgical procedure, comprising:
 introducing a catheter into the vasculature of a patient, said delivery catheter having an inner shaft and an outer sheath substantially surrounding said inner shaft;   causing relative rotation between said inner shaft and said outer sheath.   
     
     
         2 . The method of  claim 1 , further comprising the step of:
 deploying a prosthetic device at a treatment location within the patient.   
     
     
         3 . The method of  claim 2 , wherein said treatment location is a blood vessel. 
     
     
         4 . The method of  claim 2 , wherein said prosthetic device is a prosthetic heart valve. 
     
     
         5 . The method of  claim 4 , wherein said catheter comprises a deployment mechanism operatively connected to said outer sheath and said inner shaft, said deployment mechanism adapted to maintain said prosthetic heart valve in a contracted state and to transform said prosthetic heart valve to a fully expanded state. 
     
     
         6 . The method of  claim 5 , wherein said deployment mechanism includes a first tube having a plurality of slots attached to said outer sheath. 
     
     
         7 . The method of  claim 6 , wherein said deployment mechanism includes a second tube having a plurality of slots attached to said inner shaft. 
     
     
         8 . The method of  claim 6 , further comprising a plurality of pins attached to said inner shaft. 
     
     
         9 . The method of  claim 8 , wherein rotation of said outer sheath relative to said inner shaft causes rotation of said first tube relative to said plurality of pins, thereby transforming said prosthetic valve from its contracted state to at least a partially expanded state. 
     
     
         10 . The method of  claim 8 , further comprising the step of:
 retracting said outer sheath proximally relative to said inner shaft.   
     
     
         11 . The method of  claim 10 , wherein said retracting step allows said prosthetic valve to transform to its fully expanded state. 
     
     
         12 . The method of  claim 11 , wherein said deployment mechanism includes at least one restraining member adapted to restrain said prosthetic valve in its fully expanded state. 
     
     
         13 . The method of  claim 12 , wherein said restraining member comprise one or more tethers. 
     
     
         14 . The method of  claim 12 , further comprising the step of:
 using said at least one restraining member to reposition said prosthetic device at said treatment location.   
     
     
         15 . The method of  claim 12 , further comprising the step of:
 using said at least one restraining member to return said prosthetic valve to its contracted state within said catheter.