Granted Patent B2

US 9,949,824 · App. 14/576,344 · Granted Apr 24, 2018

Abstract

Claims (50)

1. A prosthesis for implantation at a native semilunar valve site of a subject, the valve site having three semilunar sinuses and three native commissures, the prosthesis comprising:

a valve prosthesis support structure comprising:

a carrier structure configured to carry prosthetic valve leaflets, and

exactly three engagement arms that meet one another at three respective junctures, wherein the engagement arms are shaped so as to define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes,

wherein in an implanted position of the prosthesis:

each of the engagement arms is configured to be at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses, and

the prosthesis is configured such that the native valve leaflets are configured to be positioned between the carrier structure and the engagement arms.

2. The prosthesis according to claim 1 , wherein:

the prosthesis is configured to be implanted at a native aortic valve site of the subject, the semilunar sinuses including respective aortic sinuses; and

in the implanted position of the prosthesis, each of the engagement arms is configured to be at least partially disposed within the respective one of the aortic sinuses.

3. The prosthesis according to claim 1 , wherein:

the native semilunar valve has native leaflet roots and transitions between the semilunar sinuses; and

the engagement arms are configured to contact respective transitions between the respective semilunar sinuses and respective native leaflet roots of the native valve complex during implantation of the prosthesis.

4. The prosthesis according to claim 1 , wherein, in said implanted position, the prosthesis is configured to apply a radial force outwardly against the native semilunar valve.

5. The prosthesis according to claim 1 , wherein the prosthesis is configured, upon implantation thereof at the native semilunar valve site, to embrace leaflets of the native semilunar valve.

6. The prosthesis according to claim 1 , wherein the prosthesis is configured such that, upon implantation at the native semilunar valve site, the engagement arms are alignable with respective ones of the semilunar sinuses by rotation of the prosthesis.

7. The prosthesis according to claim 1 , wherein each of the engagement arms is configured to engage a respective one of the semilunar sinuses upon implantation of the prosthesis.

8. The prosthesis according to claim 1 , wherein:

the prosthesis defines a longitudinal axis; and

each of the engagement arms is shaped to define a length, parallel to the prosthesis longitudinal axis, between (a) at least one of the junctures and (b) a contact point of one of the engagement arms that is configured to meet at the juncture with a sinus floor of the respective one of the semilunar sinuses upon implantation of the prosthesis, which length is greater than a distance of a native valve leaflet sinus to a free end of the native valve leaflet.

9. The prosthesis according to claim 1 , wherein:

the prosthesis comprises a prosthetic valve comprising one or more prosthetic leaflets; and

at least a portion of each of the prosthetic leaflets is configured to assume a closed position during diastole and an open position during systole.

10. The prosthesis according to claim 9 , wherein at least the portion of the prosthetic leaflets is not directly coupled to any of the engagement arms.

11. The prosthesis according to claim 9 , wherein:

the prosthesis defines a longitudinal axis; and

the prosthetic valve is coupled to the support structure such that at least a portion of a length of the prosthetic leaflets parallel to said longitudinal axis is configured to be positioned distal to native valve leaflets of the native semilunar valve, upon implantation of the prosthesis.

12. A prosthesis for implantation at a native valve site, the prosthesis comprising:

a fixation member configured to be positioned at least partially downstream of the native valve, the fixation member comprising:

a plurality of leaflet engagement arms configured to contact respective downstream sides of leaflets of the native valve in an implantation position of the prosthesis, the plurality of leaflet engagement arms being configured to apply a first force to tissue of the native valve in the implantation position,

a carrier element configured to contact an upstream side of leaflets of the native valve in the implantation position of the prosthesis, the carrier element being configured to apply a second force to tissue of the native valve in the implantation position of the prosthesis,

wherein the prosthesis is configured to be anchored in the implantation position at the native valve site via application of the first and second forces, and

wherein the leaflet engagement arms and the carrier element are configured to capture leaflets of the native valve therebetween in the implantation position of the prosthesis; and

prosthetic valve leaflets supported within and coupled to the carrier element.

13. The prosthesis of claim 12 , wherein the prosthesis is configured to embrace, without clamping, leaflets of the native valve during implantation of the prosthesis.

14. The prosthesis of claim 12 , wherein the prosthesis is configured to be implanted at a semilunar valve site.

15. The prosthesis of claim 12 , wherein:

the prosthesis is configured to be implanted at a native valve site comprising three leaflets and three commissures; and

the plurality of leaflet engagement arms comprises three leaflet engagement arms.

16. The prosthesis of claim 12 , wherein the plurality of leaflet engagement arms are spaced from each other by gaps therebetween such that, in the implantation position of the prosthesis, the leaflet engagement arms are configured to be respectively rotationally aligned with the leaflets of the native valve and the gaps between the leaflet engagement arms are configured to be respectively rotationally aligned with commissures of the native valve.

17. The prosthesis of claim 12 , wherein the fixation member is self-expandable.

18. The prosthesis of claim 12 , wherein the prosthetic valve leaflets are biological valve leaflets.

19. The prosthesis of claim 12 , wherein the plurality of leaflet engagement arms comprises a number of leaflet engagement arms equal to a number of the prosthetic valve leaflets.

20. The prosthesis of claim 12 , wherein the prosthesis is configured to be implanted in an endovascular procedure.

21. The prosthesis of claim 12 , wherein the second force comprises a radial outwardly directed force.

22. A prosthesis for implantation at a native semilunar valve site of a subject, the prosthesis comprising:

a valve prosthesis support structure comprising:

a tubular carrier element configured to support a valve prosthesis; and

exactly three engagement arms that meet one another at three respective junctures, the three engagement arms being shaped so as to define three peak complexes at the three respective junctures, and to define three trough complexes, each trough complex being located between two of the peak complexes;

wherein the engagement arms are positioned at respective angular locations around the tubular carrier element, at least a portion of each engagement arm being positioned radially outwardly of the tubular carrier element.

Assignments (8)