IP Library Granted Patent US 12,409,034
Granted Patent B2
US 12,409,034 · App. 17/595,916 · Granted Sep 9, 2025

Annuloplasty ring with posterior leaflet for minimally invasive treatment

Inventors: Andrea Colli (Padua, IT); Nadav Yellin (Aven Yehuda, IL); Samuel Shaolian (Newport Beach, CA); Shuki Porath (Haifa, IL); Guy Shimel (Tel Aviv, IL)
Assignee: Valcare Medical, Inc.
A61F2/2448A61F2/2463A61F2/2466A61F2210/0014A61F2220/0016A61F2220/0033
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Quick Facts
Patent No.
US 12,409,034
App. No.
17/595,916
Granted
Sep 9, 2025
Kind
B2
Abstract

An annuloplasty ring is disclosed. The annuloplasty ring includes an outer tube, a plurality of anchors, and at least one synthetic leaflet. The synthetic leaflets are in mechanical communication with the annuloplasty ring at a plurality of points. The outer tube includes a plurality of windows. The plurality of anchors are positioned inside the outer tube and about a perimeter of the outer tube. The plurality of anchors are configured to be emitted from the plurality of windows in order to anchor the annuloplasty ring to a heart valve of a patient.

Claims (36)

1. An annuloplasty device comprising:

an annuloplasty ring comprising a first end and a second end opposite the first end, the annuloplasty ring configured to transition between an elongate insertion geometry and an annular operable geometry;

a plurality of anchors disposed within the annuloplasty ring, the plurality of anchors configured to assume a deployment configuration when the annuloplasty ring is in the annular operable geometry; and

a plurality of leaflets in mechanical communication with and mechanically coupled directly to the annuloplasty ring at a plurality of points, at least one leaflet of the plurality of leaflets comprising (i) a valve frame comprising a proximal opening, and (ii) a synthetic leaflet material mechanically coupled to the valve frame, the synthetic leaflet material disposed within the proximal opening,

wherein the plurality of leaflets comprises a first leaflet positioned adjacent to the first end of the annuloplasty ring and a second leaflet positioned adjacent to the second end of the annuloplasty ring.

2. The annuloplasty device of claim 1 , wherein the valve frame comprises a shape memory metal.

3. The annuloplasty device of claim 1 , wherein the synthetic leaflet material comprises a polymeric material.

4. An annuloplasty device comprising:

an annuloplasty ring comprising a first end and a second end opposite the first end, the annuloplasty ring configured to transition between an elongate insertion geometry and an annular operable geometry;

a plurality of anchors disposed within the annuloplasty ring, the plurality of anchors configured to assume a deployment configuration when the annuloplasty ring is in the annular operable geometry; and

a plurality of leaflets in mechanical communication with and mechanically coupled directly to the annuloplasty ring at a plurality of points,

wherein the plurality of leaflets comprises a first leaflet positioned adjacent to the first end of the annuloplasty ring and a second leaflet positioned adjacent to the second end of the annuloplasty ring, at least a portion of each of the first leaflet and the second leaflet mechanically coupled to one another.

5. The annuloplasty device of claim 4 , wherein the plurality of points are on a posterior side of a native valve.

6. The annuloplasty device of claim 4 , wherein at least one leaflet of the plurality of leaflets is in mechanical communication with the annuloplasty ring at a subset of points of the plurality of points on an anterior side of the native valve.

7. The annuloplasty device of claim 4 , wherein the annuloplasty ring further comprises a plurality of anchor windows through which the plurality of anchors are deployable.

8. The annuloplasty device of claim 4 , wherein the annuloplasty ring comprises a coating.

9. The annuloplasty device of claim 8 , wherein the coating comprises a polyethylene terephthalate coating.

10. The annuloplasty device of claim 4 , wherein the annuloplasty ring comprises a shape memory metal.

11. The annuloplasty device of claim 4 , wherein the annuloplasty ring further comprises at least one snap mechanism configured to connect the first end and the second end.

12. The annuloplasty device of claim 4 , wherein at least one leaflet of the plurality of leaflets comprises a synthetic leaflet material.

13. An annuloplasty device comprising:

an annuloplasty ring comprising a first end and a second end opposite the first end, the annuloplasty ring configured to transition between an elongate insertion geometry and an annular operable geometry;

a plurality of anchors disposed within the annuloplasty ring, the plurality of anchors configured to assume a deployment configuration when the annuloplasty ring is in the annular operable geometry; and

a plurality of leaflets in mechanical communication with and mechanically coupled directly to the annuloplasty ring at a plurality of points, at least one leaflet of the plurality of leaflets comprising one or more lace holes configured to receive a suture therethrough,

wherein the plurality of leaflets comprises a first leaflet positioned adjacent to the first end of the annuloplasty ring and a second leaflet positioned adjacent to the second end of the annuloplasty ring.

14. A method of implanting an annuloplasty device within a patient, the method comprising:

delivering, into the patient, an annuloplasty ring in an elongate insertion geometry, the annuloplasty ring comprising a plurality of leaflets in mechanical communication with and mechanically coupled directly to the annuloplasty ring at a plurality of points; and

positioning the annuloplasty ring parallel to a plane of a valve annulus of the patient,

wherein the plurality of leaflets comprise a first leaflet positioned adjacent to the first end of the annuloplasty ring and a second leaflet positioned adjacent to the second end of the annuloplasty ring, at least a portion of each of the first leaflet and the second leaflet mechanically coupled to one another.

15. The method of claim 14 , wherein the annuloplasty ring is delivered using one of a trans-apical approach, a trans-septal approach, a trans-femoral approach, a trans-jugular approach, or a trans-atrial approach.

16. The method of claim 14 , wherein at least one leaflet of the plurality of leaflets comprises:

a valve frame comprising a proximal opening; and

a synthetic leaflet material mechanically coupled to the valve frame, wherein the synthetic leaflet material is disposed within the proximal opening.

17. The method of claim 16 , wherein the valve frame comprises a shape memory metal.

18. The method of claim 16 , wherein the synthetic leaflet material comprises a polymeric material.

19. The method of claim 14 , wherein at least one leaflet of the plurality of leaflets comprises a synthetic leaflet material.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2023
From: VALCARE, INC.
To: VALCARE MEDICAL, INC.
Reel/Frame 065835/0401 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 5, 2022
From: COLLI, ANDREA; YELLIN, NADAV; SHAOLIAN, SAMUEL; PORATH, SHUKI; SHIMEL, GUY
To: VALCARE, INC.
Reel/Frame 061973/0892 →
Continuity (2)
Provisional Application 62859975 · Jun 11, 2019
Related Publication 20220226116A1 · Jul 21, 2022
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