Hydraulic delivery systems for prosthetic heart valve devices and associated methods

• US 9,579,198 B2
• Filed: 02/28/2013
• Issued: 02/28/2017
• Est. Priority Date: 03/01/2012
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Deem, Mark, Gifford, Hanson III, Morriss, John, McLean, Matt, Luna, Michael
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US13/781,504
• Publication Number:
  US 20130231735A1
• Time in Patent Office: 1,461 Days
• Field of Search: 623/1.46
• US Class Current: 1/1
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

Abstract

Systems, apparatuses, and methods for treating native heart valves are disclosed herein. A system for delivering a prosthetic device into a heart of a patient includes an elongated catheter body and a delivery capsule. The delivery capsule can be hydraulically driven to deploy at least a portion of a prosthetic heart valve device. The delivery capsule can release the prosthetic heart valve device at a desired treatment site in a patient.

Claims

1. A method for delivering a prosthetic heart valve device for repair or replacement of a native valve a heart of a human patient, the method comprising:

positioning a delivery capsule of a catheter within the heart of the patient, the delivery capsule carrying the prosthetic heart valve device;

hydraulically moving the delivery capsule in a proximal direction from a containment configuration towards a deployment configuration by delivering fluid through an elongated catheter body and into a fluidically sealed fluid chamber of the delivery capsule, wherein the fluidically sealed chamber is proximal to the prosthetic heart valve device and defined by a space between an inner proximal end surface of the delivery capsule and a proximal head of a piston device located within the delivery capsule, and wherein hydraulically moving the delivery capsule in a proximal direction comprises—

delivering fluid to the fluidically sealed chamber thereby increasing the space between the proximal head and the inner proximal end surface and unsheathe the prosthetic heart valve device; and

allowing the prosthetic heart valve device to radially expand to engage tissue of the heart when the delivery capsule moves from the containment configuration towards the deployment configuration.

2. The method of claim 1 wherein allowing the prosthetic heart valve device to radially expand includes restraining an end portion of the prosthetic heart valve device within the delivery capsule while an opposing end portion of the prosthetic heart valve device moves outwardly through an opening defined by the delivery capsule.

3. The method of claim 1 wherein hydraulically moving the delivery capsule further comprises overcoming a force provided by a biasing device which urges at least a portion of the delivery capsule towards the containment configuration.

4. The method of claim 1 wherein hydraulically moving the delivery capsule includes:

moving a sheath of the delivery capsule proximally to unsheathe at least a portion of the prosthetic heart valve device; and

translationally restraining the prosthetic heart valve device while an unsheathed portion of the prosthetic heart valve device moves into contact with tissue of the heart.

5. The method of claim 4 wherein translationally restraining the prosthetic heart valve device includes holding the prosthetic heart valve device substantially stationary relative to an elongated catheter body of the catheter coupled to the delivery capsule.

6. The method of claim 4 wherein translationally restraining the prosthetic heart valve device includes holding the prosthetic heart valve device substantially stationary relative to a native annulus surrounding leaflets of a valve of the heart.

7. The method of claim 1, further comprising substantially preventing axial movement of the prosthetic heart valve device relative to an elongated catheter body coupled to the delivery capsule while the delivery capsule moves from the containment configuration to the deployment configuration.

8. The method of claim 1, further comprising restraining a proximal end of the prosthetic heart valve device with a holder on the proximal head of the piston device.

9. The method of claim 1 wherein hydraulically moving the delivery capsule in a proximal direction comprises delivering fluid to the fluidically sealed chamber located proximal to the prosthetic heart valve device such that the fluidically sealed chamber draws a sheath of the delivery capsule proximally.