Heart valve prostheses having multiple support arms and methods for percutaneous heart valve replacement

• US 10,321,992 B2
• Filed: 02/01/2016
• Issued: 06/18/2019
• Est. Priority Date: 02/01/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Quill, Jason, Savage, Padraig, Dwork, Joshua, Garde, Kshitija, Ahlberg, Sarah, Kovalsky, Igor
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/012,533
• Publication Number:
  US 20170216026A1
• Time in Patent Office: 1,233 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, wherein the main support arm includes a first arm segment coupled to the second end of the tubular portion at a first attachment point and a second attachment point and the first arm segment defines a first loop between the first and second attachment points, the first length being defined between a terminal tip of the first loop and the first and second attachment points,

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 wherein each of the first set of supplemental support arms includes a second arm segment coupled to the second end of the tubular portion at a third attachment point and a fourth attachment point and the second arm segment defines a second loop between the third and fourth attachment points, the second length being defined between a terminal tip of the second loop and the third and fourth attachment points, 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 includes a third arm segment coupled to the second end of the tubular portion at a fifth attachment point and a sixth attachment point and the third arm segment defines a third loop between the fifth and sixth attachment points, and wherein each of the second set of supplemental support arms has a third length that is less than the second length, the third length being defined between a terminal tip of the third loop and the fifth and sixth attachment points,

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 so as to be configured to pinch 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 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. The valve prosthesis of claim 1, wherein the tubular portion of the frame has a plurality of struts geometrically arranged to provide a latticework capable of being radially compressed.

13. The valve prosthesis of claim 1, wherein the first arm segment of the main support arm is an inner arm segment, and the main support arm further includes an outer arm segment coupled to the second end of the tubular portion at a seventh attachment point and an eighth attachment point and the outer arm segment defines a fourth loop between the seventh and eighth attachment points, wherein the fourth loop of the outer arm segment generally follows the shape of the first loop of the inner arm segment.

14. The valve prosthesis of claim 13, wherein the fourth loop of the outer arm segment is connected to the first loop of the inner arm segment.

15. 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 and having a first length, wherein the main support arm includes a first arm segment coupled to the second end of the valve support at a first attachment point and a second attachment point and the first arm segment defines a first loop between the first and second attachment points, the first length being defined between a terminal tip of the first loop and the first and second attachment points,

a plurality of tall supplemental support arms extending from the second end of the valve support, wherein each of the tall supplemental support arms has a second length and wherein each of the tall supplemental support arms includes a second arm segment coupled to the second end of the valve support at a third attachment point and a fourth attachment point and the second arm segment defines a second loop between the third and fourth attachment points, the second length being defined between a terminal tip of the second loop and the third and fourth attachment points, and

a plurality of short supplemental support arms extending from the second end of the valve support, wherein each of the short supplemental support arms has a third length and wherein each of the short supplemental support arms includes a third arm segment coupled to the second end of the valve support at a fifth attachment point and a sixth attachment point and the third arm segment defines a third loop between the fifth and sixth attachment points, the third length being defined between a terminal tip of the third loop and the fifth and sixth attachment points, and wherein the first length of the main support arm is longer than the respective second and third lengths of 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 relative to the second end of the valve support such that the terminal tip of the third loop of each short supplemental support arm is at the same longitudinal position as the terminal tip of the second loop of each long supplemental support arm.

16. The valve prosthesis of claim 15, wherein in the expanded configuration end portions of the tall and short supplemental support arms contact the inflow portion so as to be configured to pinch annular tissue of the heart therebetween when deployed.

17. The valve prosthesis of claim 15, 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.

18. The valve prosthesis of claim 17, wherein the main support arm and the plurality of tall supplemental support arms are disposed about the circumference of the second end so as to be configured 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 so as to be configured to engage a posterior leaflet of a native mitral valve when the valve prosthesis is in the expanded configuration within a heart.

19. The valve prosthesis of claim 15, wherein the first arm segment of the main support arm is an inner arm segment, and the main support arm further includes an outer arm segment coupled to the second end of the valve support at a seventh attachment point and an eighth attachment point and the outer arm segment defines a fourth loop between the seventh and eighth attachment points, wherein the fourth loop of the outer arm segment generally follows the shape of the first loop of the inner arm segment.

20. 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, wherein the main support arm includes an outer arm segment and an inner arm segment, the outer arm segment being coupled to the second end of the tubular portion at a first attachment point and a second attachment point and the inner arm segment being coupled to the second end of the tubular portion at a third attachment point and a fourth attachment point and the outer arm segment defining a first loop between the first and second attachment points and the inner arm segment defining a second loop between the third and fourth attachment points, the first length being defined between a terminal tip of the second loop and the third and fourth attachment points,

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 wherein each of the first set of supplemental support arms includes a first arm segment coupled to the second end of the tubular portion at a fifth attachment point and a sixth attachment point and the first arm segment defines a third loop between the fifth and sixth attachment points, the second length being defined between a terminal tip of the third loop and the fifth and sixth attachment points, 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 includes a second arm segment coupled to the second end of the tubular portion at a seventh attachment point and an eighth attachment point and the second arm segment defines a fourth loop between the seventh and eighth attachment points, and wherein each of the second set of supplemental support arms has a third length that is less than the second length, the third length being defined between a terminal tip of the fourth loop and the seventh and eighth attachment points,

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.