Transcatheter Prosthetic Heart Valve Delivery System and Method with Controlled Expansion of Prosthetic Heart Valve

• US 20140172075A1
• Filed: 12/03/2013
• Published: 06/19/2014
• Est. Priority Date: 04/21/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Murray, Robert J. III, Tabor, Charles, Crisman, Andrew, Shipley, Adam
• Granted Patent: US 9,173,738 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

Claims

1-22. -22. (canceled)

23. A method of performing a therapeutic procedure on a defective heart valve of a patient, the method comprising:

receiving a delivery system loaded with a self-expanding prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a shaft assembly slidably positioned within a delivery sheath, the shaft assembly including a first coupling structure disposed near a distal end of the shaft assembly and coupled to a distal end of the prosthetic heart valve via a first tether, the delivery sheath containing the prosthetic heart valve in a compressed arrangement;

manipulating the delivery system to guide the prosthetic heart valve through the patient'"'"'s vasculature and into the defective heart valve;

withdrawing the delivery sheath from the prosthetic heart valve;

rotating the first coupling structure in a first direction to provide a controlled expansion of the distal end of the prosthetic heart valve; and

releasing the prosthetic heart valve from the delivery system.

24. The method of claim 23, and further comprising:

evaluating a position of the prosthetic heart valve after providing the controlled expansion;

rotating the first coupling structure in a second direction to provide a controlled contraction of the prosthetic heart valve; and

manipulating the delivery system to reposition the prosthetic heart valve after providing the controlled contraction.

25. The method of claim 23, wherein the shaft assembly includes a second coupling structure coupled to a proximal end of the prosthetic heart valve via a second tether, and wherein the method further comprises:

rotating the second coupling structure in the first direction to provide a controlled expansion of the proximal end of prosthetic heart valve.