Transcatheter Prosthetic Heart Valve Delivery Device with Stability Tube and Method

Abstract

A device for percutaneous delivery of a stented prosthetic heart valve. The device includes a sheath, a handle, and an outer stability tube. The sheath includes a distal capsule and a proximal shaft. The handle has a housing maintaining an actuator mechanism that is coupled to the shaft. The actuator mechanism is configured to selectively move the shaft, and thus the capsule, relative to the housing. The stability tube is coupled to the housing and is coaxially received over the shaft such that the shaft is slidable relative to the stability tube. In a delivery state, the capsule encompasses the prosthetic valve. In a deployed state, the capsule is withdrawn from the prosthetic valve. The shaft slides relative to the stability tube in transitioning from the loaded state to the deployed state. When used with an introducer device, the stability tube frictionally isolates the sheath.

What is claimed is: 
     
         1 . A method for restoring a defective heart valve of a patient, the method comprising:
 receiving a delivery device loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath containing the prosthetic heart valve in a compressed arrangement and an outer stability tube coaxially received over the delivery sheath and terminating proximal the prosthetic heart valve in a delivery state of the delivery device;   establishing an access portal to a bodily lumen of the patient with an introducer device including an introducer sheath and a valve;   inserting the prosthetic heart valve into the bodily lumen through the introducer valve while the prosthetic heart valve is constrained within the delivery sheath, including hemostasis being established between the introducer valve and the outer stability tube;   manipulating the delivery system to guide the prosthetic heart valve through the patient's vasculature and into the defective heart valve; and   withdrawing the delivery sheath from the prosthetic heart valve, including the delivery sheath sliding relative to the outer stability tube to release the prosthetic heart valve from the delivery sheath and permitting the prosthetic heart valve to self-expand into engagement with the native heart valve.   
     
     
         2 . The method of  claim 1 , wherein withdrawing the delivery sheath includes the outer stability tube isolating the delivery sheath from the introducer valve. 
     
     
         3 . The method of  claim 2 , wherein withdrawing the delivery sheath is characterized by the absence of frictional contact between the delivery sheath and the introducer device. 
     
     
         4 . The method of  claim 2 , wherein withdrawing the delivery sheath is characterized by the absence of a sliding force being transmitted from the delivery sheath onto the introducer device.