Device And Methods For Reducing Cardiac Valve Regurgitation

• US 20090131880A1
• Filed: 05/22/2006
• Published: 05/21/2009
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Speziali, Giovanni, Bruce, Charles
• Granted Patent: US 7,854,762 B2
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Devices and methods that may be used to reduce valve regurgitation are disclosed by locating a body across the regurgitant valve. When the valve closes, the body obliterates/ameliorates the regurgitant orifice in the valve, thereby reducing or preventing valve regurgitation. The body may be expandable. The devices may be implantable such that they can remain in place within a subject for extended periods of time.

Claims

1. A device for reducing regurgitant flow through a cardiac valve, the device comprising:

an expandable body, wherein the body comprises a collapsed profile adapted for percutaneous delivery of the body to an internal body location and an expanded profile larger than the collapsed profile, wherein the body is adapted to close a regurgitant orifice in a cardiac valve when in the expanded profile;

a tether attached to the body, wherein the tether comprises a proximal end attached to the body and a distal end distal from the body; and

an anchor located at the distal end of the tether, wherein the anchor is adapted to fix the position of the distal end of the tether at a selected location.

2. A device according to claim 1, wherein the expandable body comprises an inflatable balloon, and wherein the device further comprises an inflation lumen in fluid communication with the inflatable balloon, wherein the inflatable balloon can be expanded to place the expandable body in the expanded profile by delivering an inflation fluid into the inflatable balloon through the inflation lumen.

3. A device according to claim 2, wherein the inflation fluid comprises a radio-opaque substance.

4. A device according to claim 1, wherein the expandable body comprises a supporting structure and a sheet material attached to the supporting structure.

5. A device according to claim 4, wherein the sheet material comprises a polymeric film.

6. A device according to claim 1, wherein the expandable body is constructed of fluid-impermeable materials.

7. A device according to claim 1, wherein the expandable body comprises a dynamic hemodynamic conformational shape that changes in response to fluid flow and/or pressure variations around the expandable body.

8. A device according to claim 1, wherein a location of the expandable body on the tether can be adjusted.

9. A device according to claim 1, wherein the cross-sectional profile of the expandable body is selected from the group consisting of round, oval, flattened oval, triangular, fluted, and combinations of two or more thereof.

10. A method of reducing regurgitant flow through a cardiac valve, the method comprising:

providing a device comprising;

an expandable body, wherein the body comprises a collapsed profile adapted for percutaneous delivery of the body to an internal body location and an expanded profile larger than the collapsed profile, wherein the body is adapted to close a regurgitant orifice in a cardiac valve when in the expanded profile;

a tether attached to the body, wherein the tether comprises a proximal end attached to the body and a distal end distal from the body; and

an anchor located at the distal end of the tether;

delivering the device to an internal body location;

attaching the anchor to tissue at a selected location, wherein the expandable body is located across a regurgitant cardiac valve; and

expanding the expandable body from its collapsed profile to its expanded profile.

11. A method according to claim 10, wherein expanding the expandable body comprises inflating a balloon located within the expandable body.

12. A method according to claim 11, wherein the inflating comprises delivering an inflation fluid to the expandable body, wherein the inflation fluid comprises a radio-opaque substance.

13. A method according to claim 10, wherein the expandable body comprises a supporting structure and a sheet material attached to the supporting structure, wherein expanding the expandable body comprises expanding the supporting structure.

14. A method according to claim 13, wherein the sheet material comprises a polymeric film.

15. A method according to claim 10, wherein the expandable body is constructed of fluid-impermeable materials.

16. A method according to claim 10, wherein the expandable body comprises a dynamic hemodynamic conformational shape that changes in response to fluid flow and/or pressure variations around the expandable body.

17. A method according to claim 10, further comprising adjusting a location of the expandable body on the tether after attaching the anchor.

18. A method according to claim 10, wherein the cross-sectional profile of the expandable body is selected from the group consisting of round, oval, flattened oval, triangular, fluted, and combinations of two or more thereof.

19. A method according to claim 10, further comprising selecting the expandable body to correlate with the shape of a regurgitant orifice in the regurgitant valve.

20. A device for reducing regurgitant flow through a cardiac valve, the device comprising:

an expandable body in the form of an inflatable balloon, wherein the expandable body comprises a collapsed profile adapted for percutaneous delivery of the expandable body to an internal body location and an expanded profile larger than the collapsed profile, wherein the expandable body is adapted to close a regurgitant orifice in a cardiac valve when in the expanded profile;

an inflation lumen in fluid communication with the inflatable balloon, wherein the inflatable balloon can be expanded to place the expandable body in the expanded profile by delivering an inflation fluid into the inflatable balloon through the inflation lumen;

a tether attached to the expandable body, wherein the tether comprises a proximal end attached to the expandable body and a distal end distal from the expandable body, wherein a location of the expandable body on the tether can be adjusted; and

an anchor located at the distal end of the tether, wherein the anchor is adapted to fix the position of the distal end of the tether at a selected location.

21. A method of reducing regurgitant flow through a cardiac valve, the method comprising:

providing a device comprising;

an expandable body, wherein the body comprises a collapsed profile adapted for percutaneous delivery of the body to an internal body location and an expanded profile larger than the collapsed profile, wherein the body is adapted to close a regurgitant orifice in a cardiac valve when in the expanded profile;

a tether attached to the body, wherein the tether comprises a proximal end attached to the body and a distal end distal from the body; and

an anchor located at the distal end of the tether;

identifying the shape of a regurgitant orifice in a cardiac valve;

selecting the expandable body to correlate with the shape of a regurgitant orifice in the regurgitant valve;

delivering the device to an internal body location;