HEART VALVE PROSTHESES HAVING MULTIPLE SUPPORT ARMS AND METHODS FOR PERCUTANEOUS HEART VALVE REPLACEMENT

• US 20170216026A1
• Filed: 02/01/2016
• Published: 08/03/2017
• Est. Priority Date: 02/01/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Savage, Padraig, Garde, Kshitija, Ahlberg, Sarah, Quill, Jason, Dwork, Joshua, Kovalsky, Igor
• Granted Patent: US 10,321,992 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/0037 differing in height or in length

Abstract

Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.

Claims

1. A valve prosthesis having a compressed delivery configuration and an expanded deployed configuration for deployment within a heart comprising:

a frame having

a tubular portion for retaining a prosthetic valve component therein, the tubular portion having a first end and a second end;

an inflow portion that radially extends from the first end of the tubular portion when the valve prosthesis is in the expanded configuration;

a main support arm extending from the second end of the tubular portion having a first length;

a first set of supplemental support arms extending from the second end of the tubular portion, wherein each of the first set of supplemental support arms has a second length; and

a second set of supplemental support arms extending from the second end of the tubular portion, wherein each of the second set of supplemental support arms has a third length that is less than the second length,

wherein the first length of the main support arm is longer than the respective second and third lengths of the supplemental support arms in the first and second sets of supplemental support arms.

2. The valve prosthesis of claim 1, wherein the main support arm, the first set of supplemental support arms and the second set of supplemental support arms are spaced about a circumference of the second end of the tubular portion of the frame.

3. The valve prosthesis of claim 2, wherein at least one of the second set of supplemental support arms is positioned to be diametrically opposed with the main support arm.

4. The valve prosthesis of claim 3, wherein one of the first set of supplemental support arms is circumferentially positioned on each side of the main support arm.

5. The valve prosthesis of claim 1, wherein in the expanded configuration the main support arm, the first set of supplemental support arms and the second set of supplemental support arms bend toward the first end of the tubular portion of the frame.

6. The valve prosthesis of claim 5, wherein in the expanded configuration each end portion of the supplemental support arms of the first and second sets of supplemental support arms are disposed at substantially the same longitudinal position or height relative to the tubular portion of the frame.

7. The valve prosthesis of claim 6, wherein in the expanded configuration each end portion of the supplemental support arms of the first and second sets of supplemental support arms contacts the inflow portion for pinching tissue of the heart therebetween.

8. The valve prosthesis of claim 5, wherein in the expanded configuration

a first angle is defined between the main support arm and the tubular portion of the frame;

a second angle is defined between each supplemental support arm of the first set of supplemental support arms and the tubular portion of the frame; and

a third angle is defined between each supplemental support arm of the second set of supplemental support arms and the tubular portion of the frame,

wherein the first, second and third angles are not equal.

9. The valve prosthesis of claim 8, wherein the first angle is greater than the second angle and the second angle is greater than the third angle.

10. The valve prosthesis of claim 1, further comprising:

a prosthetic valve secured within the tubular portion of the frame; and

sealing material secured to the frame to cover one or more of portions of the tubular portion, the inflow portion, and at least an end portion of the main support arm and an end portion of each of the supplemental support arms of the first and second sets of supplemental support arms.

11. The valve prosthesis of claim 10, further comprising:

a cushioning strip disposed around a portion of a perimeter of the second end of the frame to cover and extend between curved portions of each of the supplemental support arms of the first and second sets of supplemental support arms when the valve prosthesis is in the expanded configuration

12. A valve prosthesis having a compressed delivery configuration and an expanded deployed configuration for deployment within a heart comprising:

a frame having

a valve support with a first end and a second end;

an inflow portion that radially extends from the first end of the valve support when the valve prosthesis is in the expanded configuration;

a main support arm extending from the second end of the valve support;

a plurality of tall supplemental support arms extending from the second end of the valve support; and

a plurality of short supplemental support arms extending from the second end of the valve support, wherein the main support arm is longer than the pluralities of tall and short supplemental support arms, and

wherein in the expanded configuration the main support arm, the plurality of tall supplemental support arms and the plurality of short supplemental support arms bend toward the first end of the valve support, and

wherein in the expanded configuration each of the plurality of tall supplemental support arms and each of the plurality of short supplemental support arms has substantially the same deployed height.

13. The valve prosthesis of claim 12, wherein in the expanded configuration end portions of the tall and short supplemental support arms contact the inflow portion for pinching annular tissue of the heart therebetween when deployed.

14. The valve prosthesis of claim 12, wherein the main support arm and the pluralities of tall and short supplemental support arms are spaced about a circumference of the second end of the valve support.

15. The valve prosthesis of claim 14, wherein the main support arm and the plurality of tall supplemental support arms are disposed about the circumference of the second end to engage an anterior leaflet of a native mitral valve when the valve prosthesis is in the expanded configuration within a heart, and wherein the plurality of short supplemental support arms are disposed about the circumference of the second end to engage a posterior leaflet of a native mitral valve when the valve prosthesis is in the expanded configuration within a heart.

16. A method of deploying a valve prosthesis having a compressed configuration for delivery to a treatment site and an expanded configuration for deployment within a heart comprising:

providing transatrial access to a left atrium of the heart;

advancing a distal portion of a delivery catheter having the valve prosthesis in the compressed configuration therein into the left atrium via the transatrial access, wherein the valve prosthesis includes a frame having a main support arm and a plurality of supplemental support arms;

deploying within the left atrium the main support arm and the plurality of supplemental support arms of the valve prosthesis such that the main support arm and each of the plurality of supplemental support arms assumes a bent deployed state as it extends from the distal portion of the delivery catheter;

advancing the distal portion of the delivery catheter toward an annulus of a native mitral valve of the heart until the main support arm and the plurality of supplemental support arms in the bent deployed state are pushed through the annulus and into a left ventricle of the heart;

proximally retracting the delivery catheter until each of the main support arm and the plurality of supplemental support arms engages at least a portion of anterior and posterior leaflets of the native mitral valve; and

deploying a remainder of the valve prosthesis from the delivery catheter to replace the native mitral valve.

17. The method of claim 16, further comprising:

orienting the main support arm of the valve prosthesis with an A2 segment of the anterior leaflet of the native mitral valve prior to performing the step of advancing the distal portion of the delivery catheter toward an annulus of the native mitral valve.

18. The method of claim 17, wherein during the step of proximally retracting the delivery catheter the main support arm of the valve prosthesis is configured to engage and capture the anterior leaflet at the A2 segment prior to the plurality of supplemental support arms engaging remaining segments of the anterior leaflet and segments of the posterior leaflet.

19. The method of claim 16, wherein during the step of proximally retracting the delivery catheter end portions of the plurality of supplemental support arms are forced against the annulus and the force is maintained against the annulus while the step of deploying a remainder of the valve prosthesis is performed.

20. The method of claim 19, wherein the step of deploying a remainder of the valve prosthesis includes releasing within the left atrium an inlet section of the frame of the valve prosthesis to act against a floor of the left atrium in opposition to the plurality of supplemental support arms that act against an inferior side of the annulus to thereby anchor the valve prosthesis within the native mitral valve.