Prosthetic valve with atrial arms

• US 10,736,742 B2
• Filed: 10/02/2019
• Issued: 08/11/2020
• Est. Priority Date: 02/05/2015
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US16/591,330
• Publication Number:
  US 20200038181A1
• Time in Patent Office: 314 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements

Abstract

A valve frame is shaped to define a plurality of atrial arms, and a tubular portion that defines a lumen along a longitudinal axis of the valve frame. Prosthetic leaflets within the lumen are coupled to the frame. An outer frame defines a ring and a plurality of ventricular legs coupled to the ring. The ring circumscribes the tubular portion, and is defined by a pattern of alternating peaks and troughs. The tubular portion defines a row of upstream cells, and a row of downstream cells that is tessellated with the row of upstream cells. Each of the atrial arms is attached to, and extends from, a respective connection site at which adjacent upstream cells are connected to each other. Other embodiments are also described.

Claims

1. Apparatus for use with a native valve that is disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising:

a valve frame, shaped to define a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis;

a plurality of prosthetic leaflets, coupled to the frame, disposed within the lumen, and arranged to provide unidirectional flow of blood from an upstream end of the lumen to a downstream end of the lumen; and

an outer frame, shaped to define;

a first ring, circumscribing the tubular portion, and defined by a pattern of alternating peaks and troughs, the peaks being longitudinally closer to the upstream end than to the downstream end, the troughs being longitudinally closer to the downstream end than to the upstream end,

a second ring, circumscribing the tubular portion, and defined by a pattern of alternating peaks and troughs, and

a plurality of legs, each of the legs coupled to the first ring and to the second ring, and defining a tissue-engaging flange configured to engage tissue of the ventricle,

wherein;

the tubular portion defines;

a plurality of upstream cells arranged in an upstream row that circumscribes the axis, each of the upstream cells being connected to each of two adjacent upstream cells at a respective upstream-cell-connection site; and

a plurality of downstream cells arranged in a downstream row that circumscribes the axis and is tessellated with the upstream row, each of the downstream cells being connected to each of two adjacent downstream cells at a respective downstream-cell-connection site, and

the valve frame is further shaped to define a plurality of atrial arms, each of the atrial arms;

attached to, and extending from, a respective upstream-cell-connection site, and

configured to be placed against an upstream surface of the native valve.

2. The apparatus according to claim 1, wherein the downstream row is tessellated with the upstream row such that each of the upstream-cell-connection sites is an upstream extremity of a respective downstream cell.

3. The apparatus according to claim 1, wherein a respective atrial arm of the plurality of atrial arms extends from every one of the upstream-cell-connection sites.

4. The apparatus according to claim 1, wherein each of the upstream cells is roughly diamond-shaped.

5. The apparatus according to claim 4, wherein each of the downstream cells is roughly diamond-shaped.

6. The apparatus according to claim 1, wherein each of the legs is coupled to the first ring at a respective one of the troughs of the first ring.

7. The apparatus according to claim 6, wherein each of the legs is coupled to the second ring at a respective one of the troughs of the second ring.

8. The apparatus according to claim 1, wherein the second ring is longitudinally closer than the first ring to the upstream end, and wherein the outer frame is fixed to the tubular portion at a plurality of coupling points, the plurality of coupling points being circumferentially arranged around the axis on a transverse plane that is (i) orthogonal to the axis, and (ii) longitudinally between the upstream end and the downstream end, but not at the upstream end or the downstream end.

9. The apparatus according to claim 1, wherein the second ring is longitudinally closer than the first ring to the upstream end, and wherein the outer frame is fixed to the tubular portion at a plurality of coupling points, the plurality of coupling points being circumferentially arranged around the axis on a transverse plane that is (i) orthogonal to the axis, and (ii) longitudinally between the troughs of the second ring and the troughs of the first ring.

10. The apparatus according to claim 9, wherein the transverse plane is longitudinally between the troughs of the second ring and the peaks of the first ring.

11. The apparatus according to claim 1, wherein the pattern of the first ring and the pattern of the second ring are in phase, such that the peaks of the first ring are circumferentially aligned with the peaks of the second ring, and the troughs of the first ring are circumferentially aligned with the troughs of the second ring.

12. The apparatus according to claim 1, wherein:

the second ring is longitudinally closer than the first ring to the upstream end,

each of the legs has a first portion that extends between the first ring and the second ring, and

the flange of each of the legs is longitudinally closer than the second ring to the upstream end.

13. The apparatus according to claim 12, wherein the first ring is coupled to each of the legs at a downstream end of the leg.

14. The apparatus according to claim 12, wherein each of the arms extends radially outward, upstream of a respective peak of the second ring.

15. The apparatus according to claim 1, wherein each of the peaks of the first ring is circumferentially aligned with a respective one of the arms.

16. The apparatus according to claim 1, wherein each of the peaks of the first ring is circumferentially aligned with a respective one of the upstream-cell-connection sites.