Valve prosthesis and method for delivery

• US 10,213,302 B2
• Filed: 06/24/2015
• Issued: 02/26/2019
• Est. Priority Date: 01/08/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kovalsky, Igor, Hariton, Ilia, Tuval, Yossi, Yellin, Nadav
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US14/748,693
• Publication Number:
  US 20150289977A1
• Time in Patent Office: 1,343 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

Heart valve prostheses are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame including a first portion and a second portion. In the collapsed configuration, the first portion is positioned adjacent to the second portion. In the expanded configuration, the first portion moves to be positioned within an interior area of the second portion.

Claims

1. A valve prosthesis comprising:

a valve body; and

a unitary frame including

a first tubular portion connected to the valve body, and

a second tubular portion configured to contact and conform to a native valve annulus in situ,

the unitary frame having

a delivery configuration in which the first tubular portion is positioned in series with the second tubular portion along a longitudinal axis of the unitary frame and the first tubular portion is longitudinally adjacent to the second tubular portion, and

an expanded configuration in which the first tubular portion is positioned within an interior area of the second tubular portion, such that the second tubular portion surrounds the first tubular portion and both of the first tubular portion and the second tubular portion extend parallel to the longitudinal axis of the unitary frame.

2. The valve prosthesis of claim 1, wherein the unitary frame in the expanded configuration includes the entire first tubular portion positioned within the interior area of the second tubular portion.

3. The valve prosthesis of claim 1, wherein the first tubular portion and the second tubular portion of the unitary frame are integrally formed and are connected to each other by a third portion of the unitary frame extending between the first tubular portion and the second tubular portion.

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

engagement arms configured to engage native valve leaflets, the engagement arms being connected to the unitary frame in the first tubular portion.

5. A valve prosthesis comprising:

a valve body; and

a unitary frame including

a first tubular portion connected to the valve body,

a second tubular portion configured to contact and conform to a native valve annulus in situ, and

a third portion that connects the first tubular portion with the second tubular portion,

wherein the unitary frame includes a delivery configuration in which the first tubular portion is positioned in series with the second tubular portion along a longitudinal axis of the unitary frame and the first tubular portion is longitudinally separated from the second tubular portion by the third portion, and

wherein the unitary frame includes an expanded configuration in which the first tubular portion is positioned within an interior area of the second tubular portion, such that the second tubular portion surrounds the first tubular portion and both of the first tubular portion and the second tubular portion extend parallel to the longitudinal axis of the unitary frame with the third portion at least partially radially extending therebetween.

6. The valve prosthesis of claim 5, wherein the first tubular portion, the second tubular portion, and the third portion of the unitary frame are integrally formed.

7. The valve prosthesis of claim 5, wherein the third portion of the unitary frame comprises a plurality of connecting arms having first ends attached to the first tubular portion of the unitary frame and second ends attached to the second tubular portion of the unitary frame.

8. The valve prosthesis of claim 7, wherein each of the first and second tubular portions of the unitary frame includes a plurality of cells that form a cell pattern.

9. The valve prosthesis of claim 5, wherein the third portion of the unitary frame comprises a plurality of V-shaped connecting arms.

10. The valve prosthesis of claim 9, wherein a pair of first ends of each V-shaped connecting arm is attached to the first tubular portion of the unitary frame and wherein a second end of each V-shaped connecting arm is attached to the second tubular portion of the unitary frame.

11. The valve prosthesis of claim 10, wherein each of the first and second tubular portions of the unitary frame includes a plurality of cells that form a cell pattern.

12. The valve prosthesis of claim 5, wherein a longitudinal length of the first tubular portion of the unitary frame is greater than a longitudinal length of the second tubular portion of the unitary frame.

13. The valve prosthesis of claim 5, wherein the unitary frame further comprises a pair of engagement arms configured to engage native valve leaflets, the pair of engagement arms being connected to the unitary frame in the first tubular portion.

14. The valve prosthesis of claim 13, wherein a first engagement arm of the pair of engagement arms has a longitudinal length that is different from a longitudinal length of the second engagement arm of the pair of engagement arms.

15. A valve prosthesis comprising:

a valve body; and

a unitary frame including

an inner tubular portion connected to the valve body, the inner tubular portion defining a plurality of cells,

an outer tubular portion configured to contact and conform to a native valve annulus in situ, the outer tubular portion defining a plurality of cells, and

a plurality of connecting arms extending between and connecting the inner tubular portion and the outer tubular portion,

wherein the unitary frame includes a delivery configuration in which the inner tubular portion is positioned in series with the outer tubular portion along a longitudinal axis of the unitary frame and the inner tubular portion is longitudinally separated from the outer tubular portion by the plurality of connecting arms, and

wherein the unitary frame includes an expanded configuration in which the inner tubular portion is positioned at least partially within an interior area of the outer tubular portion such that the outer tubular portion surrounds the inner tubular portion and both of the inner tubular portion and the outer tubular portion extend parallel to the longitudinal axis of the unitary frame with the plurality of connecting arms at least partially radially extending therebetween.

16. The valve prosthesis of claim 15, wherein the plurality of connecting arms each have a first end attached to the inner tubular portion of the unitary frame and a second end attached to the outer tubular portion of the unitary frame.

17. The valve prosthesis of claim 15, wherein each connecting arm of the plurality of connecting arms is V-shaped and wherein a pair of first ends of each connecting arm is attached to the inner tubular portion of the unitary frame and wherein a second end of each connecting arm is attached to the outer tubular portion of the unitary frame.

18. The valve prosthesis of claim 15, wherein a longitudinal length of the inner tubular portion of the unitary frame is greater than a longitudinal length of the outer tubular portion of the unitary frame and the unitary frame in the expanded configuration includes a first section of the inner tubular portion positioned within the interior area of the outer tubular portion and a second section of the inner tubular portion positioned outside the interior area of the outer tubular portion.

19. The valve prosthesis of claim 15, wherein a longitudinal length of the inner tubular portion of the unitary frame is less than or equal to a longitudinal length of the outer tubular portion of the unitary frame and the unitary frame in the expanded configuration includes the entire inner tubular portion positioned within the interior area of the outer tubular portion.

20. The valve prosthesis of claim 15, wherein the unitary frame further comprises a pair of engagement arms configured to engage native valve leaflets, the pair of engagement arms being connected to the unitary frame in the inner tubular portion.