Device for placement in the tricuspid annulus

• US 9,445,893 B2
• Filed: 11/21/2012
• Issued: 09/20/2016
• 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
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/359,646
• Publication Number:
  US 20140350662A1
• Time in Patent Office: 1,399 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• 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 flexible blood flow control element having an expanded state with a convex dome shape sized to cover most or all of a natural tricuspid annulus and said convex dome shape having an internal volume adapted to capture a volume of blood therein, and

a ring shaped support element configured to fit and be anchored to at least a portion of the tricuspid annulus between an atrium and a ventricle, said blood flow control element coupled to at least two points across said ring shaped support element to extend said blood flow control element across said tricuspid annulus when said support element is anchored to said tricuspid annulus, said blood flow control element configured to extend away from said support element in said expanded state toward said atrium such that said internal volume is inside an atrium during ventricle systole when said support element is anchored to said tricuspid annulus.

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

3. A device according to claim 1, wherein said internal volume is between 5 and 20 ml.

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

5. 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.

6. A device as in claim 5, 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 mm².

7. A device as in claim 5, wherein said flow control element comprises one or more apertures for said regurgitation.

8. 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.

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

10. A device according to claim 1, wherein said support element is adapted to contact and be anchored to at least a portion of said annulus including at least 180 degrees of a circumference thereof.

11. A device according to claim 10, wherein said blood flow control element spans at least 90% of said circumference.

12. A device according to claim 1, wherein said support element is radially expandable.

13. A device according to claim 1, wherein said device comprises a plurality of tissue fixation elements.

14. A device as in claim 13, 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.

15. A device according to claim 1, 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.

16. A device according to claim 1, wherein said support is sized to surround the tricuspid annulus over an arc length of at least 180 degrees.

17. A device according to claim 1, said device configured for replacing a tricuspid valve, said device wherein said support element is relatively rigid, said support element comprising a plurality of tissue fixation elements adapted to pierce tissue or otherwise interfere with conduction in-fixed to tissue;

and

a prosthetic valve or part thereof coupled to said support.

18. The device of claim 1, wherein said blood flow element is adapted to allow said volume of blood to regurgitate through said annulus during at least some part of a systole.

19. The device of claim 1, wherein said flow control element is coupled to only a portion of said support element such that blood is allowed to flow between said flow control element and said support element when said blood flow control element is in the collapsed state during ventricle diastole.

20. A device as in claim 19, wherein said flow control member includes a pleat for folding during said collapsed state.

21. The device of claim 1, wherein said flow control element is coupled to only a portion of said support element such that blood is allowed to flow between said flow control element and said support element is in said expanded state during ventricle systole.

22. A device as in claim 1, further comprising an inversion prevention element extending from said support into a space between said flow control element and a ventrical side of said support, said inversion prevention element blocking movement of said flow control element toward said ventrical side of said support.

23. A device as in claim 1, further comprising an inversion prevention element extending inward from said support, said inversion prevention element preventing movement of said flow control element toward said ventrical side of said support, wherein said inversion prevention element spans said support.

24. A device as in claim 1, wherein said flow control element is structured and selected to have an elasticity weak enough to be expanded by systolic flow, but which is not overcome by diastolic flow, so that said flow control element does not invert toward a ventrical side of said support during diastolic flow.

25. A device as in claim 1, wherein said flow control member is of non-uniform thickness and wherein the thickness of the flow control element is increased in at least one location where the flow control member joins the base.

26. A method of treating tricuspid regurgitation in a patient in need of treatment thereof comprising:

percutaneously deploying a device into a tricuspid annulus of the patient;

contacting a ring shaped support element of the device to at least 180 degrees of the circumference of the tricuspid annulus;

anchoring said support element to said tricuspid annulus;

coupling a dome shaped blood flow control element to at least two points across the support element thereby extending the dome shaped blood flow control element across the tricuspid annulus; and

temporarily storing regurgitating blood from a ventricle of the patient in an atrium of the patient in an inner volume of the dome shaped blood flow control element.

27. A method according to claim 26, 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.

28. A method as in claim 26, wherein said device is deployed without contacting at least one of an atrioventricular node and a bundle of his.

29. A method according to claim 26, comprising selecting said device to reduce an amount of regurgitated blood by 30%-80%, thereby treating said regurgitation.

30. A method according to claim 26, comprising selecting said device to temporarily capture at least 50% of regurgitated blood, thereby treating said regurgitation.

31. A method according to claim 26, 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.