DEVICE FOR PLACEMENT IN THE TRICUSPID ANNULUS

• US 20140350662A1
• Filed: 11/21/2012
• Published: 11/27/2014
• Est. Priority Date: 11/21/2011
• Status: Active Grant

• Current Assignee: Trisol Medical Ltd.
• Original Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Inventors: Vaturi, Mordehay
• Granted Patent: US 9,445,893 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A device (200) for implantation in or near an annulus of a tricuspid valve comprising at least one blood flow control element (202) adapted to capture a volume of blood therein. Optionally or alternatively, the blood flow control element is adapted to allow at least some volume of blood (406) to regurgitate through the annulus during at least some part of systole. Optionally or alternatively, the device comprises a relatively rigid annulus with an arc length of less than 300 degrees. Optionally or alternatively, the relatively rigid annulus comprises a plurality of tissue fixation elements positioned along no more than 300 degrees of a circumference of the annulus, for example to avoid damaging conduction pathways between an atria and a chamber.

Claims

1. A device for implantation at or near an annulus of a tricuspid valve comprising at least one blood flow control element adapted to capture a volume of blood therein, wherein the volume of blood is held by said at least one blood flow control element in an atrium;

wherein said device is configured to be anchored to at least a portion of the tricuspid annulus.

5. A device according to claim 1, wherein said blood flow control element is a sail.

6. A device according to claim 1, wherein said volume of blood is between 5 and 20 ml.

8. A device according to claim 1, wherein said volume of blood is at least 8 mL.

9. A device according to claim 1, wherein said device is adapted for allowing at least some blood to regurgitate through said annulus during systole, wherein said at least some blood is between 3 and 25 mL.

11. A device as in claim 9, wherein said device is adapted for allowing at least some blood to regurgitate through said annulus during systole, and wherein a total area for said blood regurgitation is no more than 20 mm ².

16. A device according to claim 1, wherein said device comprises one or more members adapted to retain most of said blood flow control element in an atrial aspect of said device during diastole.

19. A device as in claim 1, wherein said size of said device is sufficiently short to preserve function of a septal leaflet.

22. A device according to claim 1, further comprising a support element adapted to contact at least a portion of said annulus, said element coupled to said support element, wherein said support element has an incomplete circumference of between 180 and 300 degrees.

25. A device according to claim 22, wherein said blood flow control element spans at least 90% of said incomplete circumference.

26. A device according to claim 22, wherein said support element is radially expandable.

27. A device according to claim 1, wherein said device comprises a plurality of tissue fixation elements, said tissue fixation elements located along no more than 270 degrees along a circumference of said device, leaving a gap of at least 7 mm.

28. A device as in claim 27, wherein at least some of said tissue fixation elements are positioned to fixate to at least one of a ventricular aspect of said annulus and an atrial aspect of said annulus.

30. A device according to claim 22, wherein said support element has a non-symmetrical shape and said support element is adapted to have an open contiguous area of at least 1 cm², said contiguous area is adapted to be placed towards a coronary sinus.

31. A device according to claim 1, wherein said device is sized to maintain a gap of at least 3 mm between said blood flow control element and at least one remaining functional tricuspid leaflet, said gap along at least 50% of a length of said leaflet.

32. A device according to claim 1, wherein said device is configured for replacing at least one leaflet of a tricuspid valve, said device further comprising:

a relatively rigid support, said support having an arc length of between 180 degrees and 300 degrees;

wherein said at least one blood flow control element is configured for controlling flow, said element coupled to said rigid support, wherein said element resists flow less for flow from the atrium than for flow from the ventricle.

33. A device according to claim 1, said device configured for replacing a tricuspid valve, said device further comprising:

a relatively rigid support, said support comprising a plurality of tissue fixation elements adapted to pierce tissue or otherwise interfere with conduction in-fixed to tissue, positioned along no more than 300 degrees of a circumference thereof; and

a prosthetic valve or part thereof coupled to said support.

2-4. -4. (canceled)

7. (canceled)

10. (canceled)

12-15. -15. (canceled)

17-18. -18. (canceled)

20-21. -21. (canceled)

23-24. -24. (canceled)

29. (canceled)

36-37. -37. (canceled)

38. A method of treating tricuspid regurgitation comprising percutaneously deploying a device, said device comprises a blood flow control element adapted to temporarily store blood from the ventricle in an atrium, in said element, and/or allow a reduced amount of regurgitation through or past the device, in a tricuspid annulus of a subject in need of treatment thereof;

wherein said device is con anchored to at least a portion of the tricuspid annulus.

34. A method according to claim 38, said deploying including deploying in an annulus of a tricuspid valve, said method further comprising expanding said device without said device contacting a membranous septum when in an implanted state.

35. A method as in claim 38, wherein said device is deployed without contacting at least one of an atrioventricular node and a bundle of His.

39. A method according to claim 38, comprising selecting said device to reduce an amount of regurgitated blood by 30%-80%, thereby treating said regurgitation.

40. A method according to claim 38, comprising selecting said device to temporarily capture at least 50% of regurgitated blood, thereby treating said regurgitation.

44. A method according to claim 38, said device configured for:

capturing at least some volume of regurgitated blood in said blood flow control element during at least some part of systole; and

releasing at least some volume of said captured blood into a right ventricle during at least some part of diastole.

41-42. -42. (canceled)

43. A device for implantation in the annulus of a tricuspid valve comprising at least one blood flow element adapted to allow a volume of blood to regurgitate through said annulus during at least some part of a systole;

wherein said device is configured to be anchored to at least a portion of the tricuspid annulus.

45. A device according to claim 43, wherein the volume is at least 3 mL.