IP Library Granted Patent US 11,304,804
Granted Patent B2
US 11,304,804 · App. 16/135,599 · Granted Apr 19, 2022

Prosthetic valve with connecting struts of variable size and tissue anchoring legs of variable size that extend from junctions

Inventors: Ilia Hariton (Zichron Yaackov, IL); Meni Iamberger (Kfar Saba, IL); Aviram Baum (Tel Aviv, IL); Boaz Harari (Ganey Tikva, IL)
Assignee: CARDIOVALVE, LTD.
A61F2/2427A61F2/243A61F2/2436A61F2/2445A61F2/2454A61F2/2463A61F2/246A61F2/2409A61F2/2418A61F2/2466A61F2210/0014A61F2220/0008A61F2250/007
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Quick Facts
Patent No.
US 11,304,804
App. No.
16/135,599
Granted
Apr 19, 2022
Kind
B2
Abstract

An expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an expandable valve body having an atrial end, a ventricular end opposite the atrial end, and an intermediate portion extending between the atrial end and the ventricular end. The valve body may include a plurality of struts intersecting at junctions. The prosthetic valve may also include a plurality of tissue anchoring legs extending from junctions within the intermediate portion of the valve body. At least one of the tissue anchoring legs may have a cross-sectional area which is larger by at least 20% than a cross-sectional area of a strut extending between the at least one tissue anchoring leg and an adjacent tissue anchoring leg.

Claims (45)

1. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an expandable valve body having an atrial end, a ventricular end opposite the atrial end, and an intermediate portion extending between the atrial end and the ventricular end, the valve body being formed from a plurality of struts intersecting at junctions and including an annular outer frame and an inner frame situated at least partially within the annular outer frame; and

a plurality of tissue anchoring legs extending from junctions within the intermediate portion of the valve body, wherein at least one of the tissue anchoring legs has a cross-sectional area ranging from 0.45 mm 2 -0.65 mm 2 and a strut extending between the at least one tissue anchoring leg and an adjacent tissue anchoring leg has a cross-sectional area ranging from 0.15 mm 2 -0.30 mm 2 ; and

wherein a connector pin is situated at an intersection of the at least one tissue anchoring leg and two adjacent struts of the annular outer frame.

2. The prosthetic valve of claim 1 ,

wherein the cross-sectional area of the at least one tissue anchoring leg is perpendicular to a direction of extension of the at least one tissue anchoring leg, and

wherein the cross-sectional area of the strut extending between the at least one tissue anchoring leg and the adjacent tissue anchoring leg is perpendicular to a direction of extension of the strut.

3. The prosthetic valve of claim 1 , wherein the cross-sectional area of the at least one tissue anchoring leg is four times larger than the cross-sectional area of the strut extending between the at least one tissue anchoring leg and the adjacent tissue anchoring leg.

4. The prosthetic valve of claim 1 , wherein the at least one tissue anchoring leg is configured to extend radially outward from the valve body and in a non-ventricular direction, the at least one tissue anchoring leg being configured to engage ventricular tissue of the native mitral valve.

5. The prosthetic valve of claim 1 , further comprising:

a plurality of atrial tissue anchoring arms extending radially outward from junctions within the intermediate portion of the valve body, wherein at least one atrial tissue anchoring arm is configured to extend from the valve body in an atrial direction.

6. The prosthetic valve of claim 5 , wherein the at least one atrial tissue anchoring arm is configured to extend radially outward beyond a terminal end of the at least one tissue anchoring leg.

7. The prosthetic valve of claim 1 , wherein a width of a radial outer surface of the at least one tissue anchoring leg is twice as large as a width of a radial outer surface of the strut extending between the at least one tissue anchoring leg and the adjacent tissue anchoring leg.

8. The prosthetic valve of claim 1 , further comprising:

a tissue anchoring leg base strut extending between the junction from which the at least one tissue anchoring leg extends and a ventricular end of the valve body, wherein the tissue anchoring leg base strut has a cross-sectional area which is substantially equal to the cross-sectional area of the at least one tissue anchoring leg.

9. The prosthetic valve of claim 1 , wherein the cross-sectional area of the at least one tissue anchoring leg is situated within a half of the at least one tissue anchoring leg which is radially closest to a center of the prosthetic valve.

10. The prosthetic valve of claim 9 , wherein the half of the at least one tissue anchoring leg which is radially closest to the center of the prosthetic valve has a substantially constant cross-sectional area.

11. The prosthetic valve of claim 1 , further comprising:

a second strut extending between the at least one tissue anchoring leg and the adjacent tissue anchoring leg, wherein a junction between the strut and the second strut is situated in an axial direction relative to the junction from which the at least one tissue anchoring leg extends.

12. The prosthetic valve of claim 1 , wherein a terminal end of the at least one tissue anchoring leg is configured to be situated in an axial direction relative to the atrial end of the valve body.

13. The prosthetic valve of claim 1 , wherein the at least one tissue anchoring leg and the adjacent tissue anchoring leg do not connect to the valve body at a common point of connection.

14. The prosthetic valve of claim 1 , wherein the at least one tissue anchoring leg extends from a single junction of the valve body.

15. The prosthetic valve of claim 1 , wherein an entire length of the at least one tissue anchoring leg is configured to extend radially outward and toward an atrium upon implantation.

16. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an expandable annular outer frame including a plurality of struts intersecting at junctions to form closed cells, the annular outer frame further including a plurality of ventricular tissue anchoring legs configured to extend radially outward from the junctions of the annular outer frame; and

an inner frame situated at least partially within the annular outer frame, the inner frame including a plurality of struts intersecting at junctions to form closed cells and a plurality of atrial tissue anchoring arms configured to extend radially outward from the junctions of the inner frame,

wherein at least one of the ventricular tissue anchoring legs has a cross-sectional area ranging from 0.45 mm 2 -0.65 mm 2 and a strut extending between the at least one ventricular tissue anchoring leg and an adjacent ventricular tissue anchoring leg has a cross-sectional area ranging from 0.15 mm 2 -0.30 mm 2 ; and

wherein a connector pin is situated at an intersection of the at least one ventricular tissue anchoring leg and two adjacent struts of the expandable annular outer frame.

17. The prosthetic valve of claim 16 , wherein at least one of the atrial tissue anchoring arms has a cross-sectional area which is larger by 20% than a cross-sectional area of a strut extending between the at least one atrial tissue anchoring arm and an adjacent atrial tissue anchoring arm.

18. The prosthetic valve of claim 16 , wherein at least one of the atrial tissue anchoring arms has a cross-sectional area which is larger by 20% than the cross-sectional area of the strut extending between the at least one ventricular tissue anchoring leg and the adjacent ventricular tissue anchoring leg.

19. The prosthetic valve of claim 16 , wherein at least one connection between the annular outer frame and the inner frame is positioned away from respective atrial ends of the annular outer frame and inner frame.

20. The prosthetic valve of claim 16 , wherein at least one connection between the annular outer frame and the inner frame is positioned in a ventricular direction relative to at least one atrial tissue anchoring arm and to the at least one ventricular tissue anchoring leg.

21. An expandable prosthetic valve for implantation within a native mitral valve, the prosthetic valve comprising:

an expandable valve body formed from a plurality of struts intersecting at junctions and including an annular outer frame and an inner frame situated at least partially within the annular outer frame; and

a plurality of tissue anchoring legs extending from the junctions of the valve body,

wherein at least one of the tissue anchoring legs has a cross-sectional area ranging from 0.45 mm 2 -0.65 mm 2 and a first strut extending from the at least one tissue anchoring leg toward an adjacent tissue anchoring leg has a cross-sectional area ranging from 0.15 mm 2 -0.30 mm 2 ,

wherein the at least one tissue anchoring leg and the adjacent tissue anchoring leg are angularly separated by a single junction; and

wherein a connector pin is situated at an intersection of the at least one tissue anchoring leg and two adjacent struts of the annular outer frame.

22. The prosthetic valve of claim 21 , wherein the at least one tissue anchoring leg includes an opening therein.

23. The prosthetic valve of claim 21 , further comprising:

a second strut extending from the adjacent tissue anchoring leg, wherein the first strut and second strut meet at the single junction.

24. The prosthetic valve of claim 21 , wherein the at least one tissue anchoring leg includes at least one bent portion.

25. The prosthetic valve of claim 1 , wherein the at least one tissue anchoring leg has a cross-sectional area of 0.53 mm 2 .

26. The prosthetic valve of claim 1 , wherein the strut extending between the at least one tissue anchoring leg and the adjacent tissue anchoring leg has a cross-sectional area of 0.165 mm 2 .

27. The prosthetic valve of claim 1 , wherein the strut extending between the at least one tissue anchoring leg and the adjacent tissue anchoring leg has a cross-sectional area of 0.2 mm 2 .

Assignments (2)
SECURITY INTEREST Recorded Jun 10, 2021
From: CARDIOVALVE LTD.
To: BEST, LAWRENCE C.; OXO CAPITAL VALVE VENTURES LLC; PEREGRINE VC INVESTMENTS IV (IL) L.P.; PEREGRINE VC INVESTMENTS IV (US INVESTORS) L.P; PEREGRINE VC INVESTMENTS IV (OTHER INVESTORS) L.P.; NGN BIOMED OPPORTUNITY II, L.P.; IF A PE FUND II, LP; IF A PE FUND II US, LP
Reel/Frame 056539/0833 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 2, 2018
From: HARITON, LLIA; IAMBERGER, MENI; BAUM, AVIRAM; HARARI, BOAZ
To: CARDIOVALVE, LTD
Reel/Frame 047394/0010 →
Continuity (2)
Provisional Application 62560384 · Sep 19, 2017
Related Publication 20190083244A1 · Mar 21, 2019
Cited By (5)
US 12,310,575 US 12,396,851 US 12,458,493 US 12,569,335 US 12,611,305