Catheter Assembly With Valve Crimping Accessories

Abstract

Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. In one embodiment, a catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly cap include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A valve retaining mechanism ears be included to assist in retaining the prosthetic valve prior to deployment. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

1 - 16 . (canceled) 
     
     
         17 : A method of implanting a prosthetic heart valve in a patient, comprising:
 providing a delivery catheter assembly including a handle assembly and a distal tip assembly;   encompassing a compressed prosthetic valve on the distal tip assembly with a first sleeve and a second sleeve of the distal tip assembly;   advancing the distal tip assembly that encompasses the prosthetic valve through the patient's vasculature to position the prosthetic valve at a native valvular annulus in the patient's heart;   moving a distal control knob on the handle assembly to move a first elongate member extending from the handle assembly and the first sleeve connected to the first elongate member in an axial direction to release a first portion of the prosthetic valve from the distal tip assembly;   moving a proximal control knob on the handle assembly to move a second elongate member extending from the handle assembly and the second sleeve connected to the second elongate member in an axial direction to release a second portion of the prosthetic valve from the distal tip assembly;   implanting the prosthetic valve in the patient's native valvular annulus; and   removing the distal tip assembly from the patient's vasculature.   
     
     
         18 : The method of  claim 17 , wherein the distal control knob is rotatable. 
     
     
         19 : The method of  claim 17 , wherein the proximal control knob is rotatable. 
     
     
         20 : The method of  claim 17 , wherein moving the distal control knob moves the first elongate member and the first sleeve distally. 
     
     
         21 : The method of  claim 17 , wherein moving the proximal control knob moves the second elongate member and the second sleeve proximally. 
     
     
         22 : The method of  claim 17 , wherein the prosthetic valve is self-expanding. 
     
     
         23 : The method of  claim 17 , wherein the distal control knob is connected to the first elongate member through a distal shaft boss. 
     
     
         24 : The method of  claim 23 , wherein the distal control knob is further connected to the first elongate member through a connecting bar attached to the distal shaft boss. 
     
     
         25 : The method of  claim 24 , wherein the distal control knob is further connected to the first elongate member through a proximal shaft boss coupled to the connecting bar and the first elongate member. 
     
     
         26 : The method of  claim 17 , wherein the handle assembly includes:
 a distal shaft boss engaged with the distal control knob;   a connecting bar attached to the distal shaft boss; and   a proximal shaft boss operatively coupled to the first elongate member and the connecting bar.   
     
     
         27 : The method of  claim 17 , wherein the distal tip assembly is advanced through the patent's vasculature using a transfemoral approach. 
     
     
         28 : The method of  claim 17 , wherein the distal tip assembly is advanced through the patent's vasculature using a transapical approach. 
     
     
         29 : The method of  claim 17 , wherein a portion of the distal tip assembly passes through the implanted prosthetic valve during removal. 
     
     
         30 : The method of  claim 29 , wherein the distal tip assembly includes a proximal rounded portion to prevent the portion of the distal tip assembly from damaging the implanted prosthetic valve during removal. 
     
     
         31 : The method of  claim 17 , wherein the second elongate member encompasses the first elongate member. 
     
     
         32 : The method of  claim 17 , wherein the first sleeve encompasses the second sleeve. 
     
     
         33 : The method of  claim 17 , further comprising:
 moving the distal control knob a first distance to move the first elongate member and the first sleeve a first axial distance to partially release the first portion of the prosthetic valve from the distal tip assembly; and   verifying the position of the prosthetic valve at the native valvular annulus.   
     
     
         34 : The method of  claim 33 , further comprising:
 after verifying that the prosthetic valve is correctly positioned at the native valvular annulus, moving the distal control knob a second distance to move the first elongate member and the first sleeve a second axial distance to fully release the first portion of the prosthetic valve from the distal tip assembly.   
     
     
         35 : The method of  claim 33 , further comprising:
 retracting the partially released first portion of the prosthetic valve to reposition the prosthetic valve at the native valvular annulus.