Transcatheter Prosthetic Heart Valve Delivery System with Flush Report

• US 20110264199A1
• Filed: 04/21/2011
• Published: 10/27/2011
• Est. Priority Date: 04/21/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wiemeyer, Nathan, Tran, Don
• Granted Patent: US 8,740,976 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

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 portion and an intermediate portion, and an inner lumen extending through the shaft assembly. The delivery system includes a sheath assembly defining an outer lumen sized to slidably receive the shaft assembly. At least one flush port is formed in the intermediate portion. The at least one flush port is in fluid communication with the inner lumen and the outer lumen. 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in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve.

Claims

1. A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached, the system comprising:

a shaft assembly including a distal portion and an intermediate portion, and an inner lumen extending through the shaft assembly;

a sheath assembly defining an outer lumen sized to slidably receive the shaft assembly;

at least one flush port formed in the intermediate portion, the at least one flush port in fluid communication with the inner lumen and the outer lumen; and

wherein 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in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve.

2. The delivery system of claim 1, wherein the at least one flush port is formed adjacent to a distal end of the intermediate portion.

3. The delivery system of claim 1, and further comprising:

a connector in fluid communication with the inner lumen, the connector configured to be connected to a fluid source.

4. The delivery system of claim 3, wherein the connector is formed at a proximal end of the delivery system.

5. The delivery system of claim 1, wherein a distal end of the distal portion is configured to be fluidly sealed.

6. The delivery system of claim 5, wherein sealing of the distal end of the distal portion facilitates a flow of fluid from the inner lumen through the at least one flush port and into the outer lumen.

7. The delivery system of claim 1, wherein the intermediate portion has a larger outer diameter than the distal portion.

8. The delivery system of claim 7, wherein the prosthetic heart valve is configured to be slid over the distal portion and releasably attached to the intermediate portion.

9. The delivery system of claim 1, wherein the inner lumen is a guide wire lumen configured to slidably receive a guide wire.

10. A system for performing a therapeutic procedure on a defective heart valve of a patient, the system comprising:

a delivery system including;

a shaft assembly including a distal portion, an intermediate portion, and an inner lumen extending through the shaft assembly;

a sheath assembly defining an outer lumen sized to slidably receive the shaft assembly; and

at least one flush port formed in the intermediate portion, the at least one flush port in fluid communication with the inner lumen and the outer lumen;

a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame and forming at least two valve leaflets, the prosthetic heart valve being self-expandable from a compressed arrangement to a natural arrangement; and

wherein the delivery system is configured to slidably receive the prosthetic heart valve over the distal portion within the sheath assembly and is configured to be operable 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 to permit the prosthetic heart valve to self-expand to the natural arrangement and release from the delivery system.

11. The system of claim 10, wherein the at least one flush port is formed adjacent to a distal end of the intermediate portion.

12. The system of claim 10, and further comprising:

a connector in fluid communication with the inner lumen, the connector configured to be connected to a fluid source.

13. The system of claim 12, wherein the connector is formed at a proximal end of the delivery system.

14. The system of claim 10, wherein a distal end of the distal portion is configured to be fluidly sealed.

15. The system of claim 14, wherein sealing of the distal end of the distal portion facilitates a flow of fluid from the inner lumen through the at least one flush port and into the outer lumen.

16. The system of claim 10, wherein the intermediate portion has a larger outer diameter than the distal portion.

17. The system of claim 16, wherein the prosthetic heart valve is configured to be slid over the distal portion and releasably attached to the intermediate portion.

18. The system of claim 10, wherein the inner lumen is a guide wire lumen configured to slidably receive a guide wire.

19. A method of flushing a prosthetic heart valve delivery system, 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 sheath assembly, the shaft assembly including a distal portion, an intermediate portion, and an inner lumen extending through the shaft assembly, the intermediate portion including at least one flush port formed therein, the delivery sheath defining an outer lumen and containing the prosthetic heart valve in a compressed arrangement, the at least one flush port in fluid communication with the inner lumen and the outer lumen;

fluidly sealing a distal end of the inner lumen; and

introducing fluid into the inner lumen while the distal end is fluidly sealed, thereby simultaneously flushing the inner lumen and the outer lumen.

20. The method of claim 19, and further comprising:

connecting a fluid source to a connector at a proximal end of the inner lumen to introduce the fluid into the inner lumen.