CENTERING DEVICES FOR USE WITH A VALVE PROSTHESIS DELIVERY SYSTEM AND METHODS OF USE THEREOF

• US 20160235531A1
• Filed: 01/19/2016
• Published: 08/18/2016
• Est. Priority Date: 02/12/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Ciobanu, Constantin, Duffy, Niall, White, Frank
• Granted Patent: US 10,251,748 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

Embodiments hereof relate to centering devices for use with a valve delivery system and methods of delivering a valve prosthesis within a vasculature. A valve centering catheter is configured for use with a valve delivery system. The valve centering catheter includes a circumferential centering device at a distal portion thereof, and the circumferential centering device defines a central opening there-through when in an expanded configuration. The circumferential centering device is annular or has a C-shaped cross-section. The valve delivery system is tracked through the vasculature until the valve prosthesis is positioned through the central opening of the expanded circumferential centering device. The valve centering catheter may alternatively include a longitudinal centering device which acts as a marker for depth control during delivery of a valve delivery system, which may include an integral circumferential centering device.

Claims

1. A method of delivering a valve prosthesis configured for delivery within a vasculature, the method comprising the steps of:

percutaneously introducing a valve centering catheter into a vasculature, the valve centering catheter having a circumferential centering device at a distal portion thereof, wherein the circumferential centering device is in a delivery configuration;

tracking the valve centering catheter through the vasculature until the circumferential centering device is positioned at a treatment site;

radially expanding the circumferential centering device into an expanded configuration at the treatment site, wherein the circumferential centering device defines a central opening there-through when in the expanded configuration;

percutaneously introducing a valve delivery system into the vasculature, the valve delivery system having a valve prosthesis at a distal portion thereof, wherein the valve prosthesis is in a delivery configuration;

tracking the valve delivery system through the vasculature until the valve prosthesis is positioned through the central opening of the expanded circumferential centering device in order to circumferentially center the valve prosthesis within the native anatomy of the treatment site; and

deploying at least an inflow end of the valve prosthesis into apposition with the native anatomy of the treatment site, thereby anchoring and securing the circumferentially centered position of the valve prosthesis within the native anatomy of the treatment site.

2. The method of claim 1, further comprising the steps of:

radially collapsing the circumferential centering device after only the inflow end of the valve prosthesis is deployed;

removing the radially collapsed circumferential centering device from the treatment site, wherein an outflow end of the valve prosthesis in the delivery configuration during removal of the radially collapsed circumferential centering device; and

deploying the outflow end of the valve prosthesis into apposition with the native anatomy of the treatment site after the removal of the circumferential centering device.

3. The method of claim 1, further comprising the steps of:

deploying the outflow end of the valve prosthesis into apposition with the native anatomy of the treatment site after the removal of the circumferential centering device;

radially collapsing the circumferential centering device after the outflow end of the valve prosthesis is deployed; and

removing the radially collapsed circumferential centering device from the treatment site, wherein the radially collapsed circumferential centering device is of a sufficiently small profile so that the radially collapsed circumferential centering device slips past the deployed outflow end of the valve prosthesis without dislodging the valve prosthesis.

4. The method of claim 1, further comprising the steps of:

detaching the circumferential centering device from the valve centering catheter; and

removing the valve centering catheter from the treatment site, wherein the circumferential centering device remains expanded around the valve prosthesis in situ after removal of the valve centering catheter.

5. The method of claim 4, wherein the step of radially expanding the circumferential centering device into an expanded configuration includes expanding the circumferential centering device with a self-expanding injectable substance.

6. The method of claim 1, wherein the circumferential centering device is an annular component defining the central opening there-through.

7. The method of claim 6, wherein the circumferential centering device is an inflatable balloon.

8. The method of claim 6, wherein the circumferential centering device is an expandable mesh component.

9. The method of claim 6, wherein the annular component includes a plurality of deformable regions that are configured to conform to the surrounding native anatomy.

10. The method of claim 9, wherein the three vertices are formed with a first material that is more deformable than a second material of the three segments.

11. The method of claim 1, wherein the circumferential centering device has a C-shaped cross-section defining the central opening there-through.

12. The method of claim 11, wherein the circumferential centering device is an inflatable balloon.

13. The method of claim 12, wherein the step of percutaneously introducing a valve centering catheter into a vasculature includes introducing the valve centering catheter into a radial artery and the step of percutaneously introducing a valve delivery system into the vasculature includes introducing the valve delivery system into a femoral artery.

14. The method of claim 12, wherein the valve centering catheter includes a plurality of eccentric inflation ports.

15. A method of delivering a valve prosthesis configured for delivery within a vasculature, the method comprising the steps of:

percutaneously introducing a valve centering catheter into a vasculature, the valve centering catheter having a longitudinal centering device at a distal portion thereof, wherein the longitudinal centering device is in a delivery configuration;

tracking the valve centering catheter through the vasculature until the longitudinal centering device is positioned distal to a treatment site;

radially expanding the longitudinal centering device into an expanded configuration, wherein the longitudinal centering device defines a central opening there-through when in the expanded configuration;

percutaneously introducing a valve delivery system into the vasculature, the valve delivery system having a valve prosthesis mounted at a distal portion thereof and including a circumferential centering device proximal to the valve prosthesis, wherein the valve prosthesis and the circumferential centering device are in delivery configurations;

tracking the valve delivery system through the vasculature until the valve prosthesis is positioned at the treatment site, proximal to the expanded longitudinal centering device, in order to longitudinally center the valve prosthesis within the native anatomy of the treatment site;

radially expanding the circumferential centering device of the valve delivery system into an expanded configuration, wherein the circumferential centering device defines a central opening there-through when in the expanded configuration;

deploying the valve prosthesis into apposition with the native anatomy of the treatment site, thereby anchoring and securing the longitudinally and circumferentially centered position of the valve prosthesis within the native anatomy of the treatment site.

16. The method of claim 15, wherein the longitudinal centering device and the circumferential centering device are annular inflatable balloons defining the central openings there-through.

17. The method of claim 16, wherein the circumferential centering device is integrated onto a distal capsule of the valve delivery system.

18. The method of claim 17, wherein the circumferential centering device is formed from an elastic material configured to stretch when the distal capsule is retracted.

19. The method of claim 16, wherein the circumferential centering device is integrated onto an outer shaft of the valve delivery system.

20. The method of claim 15, wherein the step of tracking the valve centering catheter through the vasculature until the longitudinal centering device is positioned distal to a treatment site includes positioning the longitudinal centering device below a native valve annulus of a native aortic valve.