HYDRAULIC DELIVERY SYSTEMS FOR PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED METHODS

• US 20170035569A1
• Filed: 10/06/2016
• Published: 02/09/2017
• 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
• Granted Patent: US 10,258,468 B2
• Time in Patent Office: Days
• 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 system for delivering a prosthetic heart valve device for implantation at a native heart valve of a patient, the system comprising;

an elongated catheter body; and

a delivery capsule coupled to the elongated catheter body and configured to be hydraulically driven between a containment configuration for holding the prosthetic heart valve device and a deployment configuration for deploying the prosthetic heart valve device,

wherein the delivery capsule comprises a biasing device configured to urge at least a portion of the delivery capsule towards the containment configuration when the delivery capsule moves from the containment configuration towards the deployment configuration.

2. :

The system of claim 1 wherein the delivery capsule comprises a containment chamber configured to contain the prosthetic heart valve device and a fluid chamber, wherein the fluid chamber is fluidically sealed from the containment chamber and in fluid communication with a fluid lumen extending along the elongated catheter body.

3. :

The system of claim 2 wherein the biasing device includes a spring positioned to be compressed as the delivery capsule moves towards the deployment configuration to unsheathe the prosthetic heart valve device when fluid is delivered through the fluid lumen and into the fluid chamber.

4. :

The system of claim 1 wherein the delivery capsule comprises a housing configured to hold the prosthetic heart valve device, the housing including;

a first portion having a closed distal first end and an open proximal first end; and

a second portion having an open distal second end and a closed proximal second end, wherein the first and second portions are movable away from one another and at least one of the open proximal first end and the open distal second end is configured to release the prosthetic heart valve device therethrough.

5. :

The system of claim 4 wherein the delivery capsule further comprises a piston device positioned within the housing, a containment chamber, and a fluid chamber, wherein the fluid chamber is fluidically sealed from the containment chamber and in fluid communication with a fluid lumen extending along the elongated catheter body such that at least one of the first portion and the second portion is driven axially to unsheathe at least a portion of the prosthetic heart valve device positioned in the containment chamber when fluid is delivered through the fluid lumen and into the fluid chamber.

6. :

The system of claim 4 wherein the biasing device is configured to urge the first and second portions towards one another.

7. :

The system of claim 4 wherein the delivery capsule includes a piston device positioned within the housing, the piston device and the housing define a fluid chamber in fluid communication with a fluid lumen in the elongated catheter body, the delivery capsule being movable towards the deployment configuration by delivering fluid through the fluid lumen and into the fluid chamber to overcome a biasing force provided by the biasing device.

8. :

The system of claim 1 wherein the delivery capsule includes;

a distal sheath;

a proximal sheath;

a distal piston device movably positioned in the distal sheath such that the distal sheath moves distally relative to the distal piston device when fluid is delivered into a distal fluid chamber defined by the distal sheath and the distal piston device; and

a proximal piston device movably positioned in the proximal sheath such that the proximal sheath moves proximally relative to the proximal piston device when fluid is delivered into a proximal fluid chamber defined by the proximal sheath and the proximal piston device.

9. :

The system of claim 8, further comprising a prosthetic heart valve device positioned within at least one of the proximal and distal sheaths and between the distal piston device and the proximal piston device, wherein the distal sheath and the proximal sheath are movable away from one another to unsheathe at least a portion of the prosthetic heart valve device.

10. :

The system of claim 8, further comprising a prosthetic heart valve device positioned within and translationally restrained by the delivery capsule, wherein the delivery capsule is configured to release the prosthetic heart valve device after a deployed portion of the prosthetic heart valve device is seated in a native valve of the heart.

11. :

The system of claim 1 wherein the biasing device includes a spring that is compressed as the delivery capsule moves away from the containment configuration to unsheathe an entire axial length of the prosthetic heart valve device.

12. :

The system of claim 11 wherein the delivery capsule includes a sheath that is movable proximally to compress the spring between a stop coupled to the sheath and a shoulder of the elongated catheter body.

13. :

The system of claim 1 wherein the elongated catheter body includes a fluid lumen in fluid communication with the delivery capsule, the delivery capsule is configured to move from the containment configuration to the deployment configuration by delivering fluid along the fluid lumen and into the delivery capsule to overcome a biasing force provided by the biasing device.

14. :

The system of claim 1 wherein the delivery capsule includes a sheath and a piston device positioned within the sheath, the piston device has a head configured to translationally restrain the prosthetic heart valve device and a sealing member positioned between the head and the sheath to form a fluid-tight seal with the sheath.

15. :

The system of claim 1 wherein the biasing device includes a spring having a proximal end and a distal end, the distal end of the spring moves proximally along the elongated catheter body towards the proximal end of the spring when the delivery capsule moves from the containment configuration towards the deployment configuration.

16. :

The system of claim 15 wherein the elongated catheter body includes an outer member and an inner member positioned within the outer member, the outer member is coupled to the proximal sheath, the inner member is coupled to the distal sheath, and the outer member is axially movable relative to the inner member to move the proximal sheath proximally.

17-115. -115. (canceled)