Sinus-engaging valve fixation member

• US 8,834,564 B2
• Filed: 03/11/2010
• Issued: 09/16/2014
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuval, Yossi, Benary, Raphael, Kilemnik, Ido
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US12/721,789
• Publication Number:
  US 20100262231A1
• Time in Patent Office: 1,650 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.3, 623 21- 219, 623/2.38, 623/2.39, 623/2.41
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Claims

1. A valve prosthesis support structure, comprising:

a collapsible outer support structure having exactly three distal outer strut supports and exactly three proximal engagement arms, each engagement arm linking two distal outer strut supports, and each engagement arm having an upwardly concave shape so as to define respective peaks at junctures with the distal outer strut supports and respective troughs between each of respective peaks, wherein the engagement arms diverge radially outward from a longitudinal axis of the valve prosthesis support structure as the engagement arms extend in a proximal direction; and

a collapsible inner support structure having exactly three distal inner strut supports extending from a proximal skirt, wherein the proximal skirt includes a flared distal portion, a narrowed throat portion, and a bulging proximal portion;

wherein each engagement arm and the proximal skirt define a space configured to receive a native valve leaflet radially between the respective engagement arm and the proximal skirt, wherein each engagement arm forms a radial outer boundary of the space, and

wherein the outer support structure is coupled to the inner support structure at respective outer and inner strut supports.

2. The valve prosthesis support structure of claim 1, wherein ends of each engagement arm are at a distance of about 0.5 mm to about 8 mm from ends of the other respective engagement arms.

3. The valve prosthesis support structure of claim 1, wherein the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the inner support structure.

4. The valve prosthesis support structure of claim 1, wherein the inner diameter at the level of the inner support struts of the inner support structure has a diameter of at least about 23 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the inner support structure.

5. The valve prosthesis support structure of claim 1, wherein the engagement arms are configured such that the troughs of the engagement arms engage surfaces of semilunar sinuses of a native valve complex.

6. The valve prosthesis support structure of claim 1, wherein the engagement arms axially overlap portions of the flared distal portion and the narrowed throat portion of the proximal skirt.

7. The valve prosthesis support of claim 1, wherein the bulging proximal portion defines a proximal edge of the valve prosthesis.

8. The valve prosthesis support of claim 1, wherein a distal edge of the flared distal portion of the proximal skirt is proximal to a distal edge of the valve prosthesis.

9. The valve prosthesis support of claim 8, wherein the distal edge of the flared distal portion of the proximal skirt is substantially and circumferentially aligned with the junctures.

10. The valve prosthesis support of claim 1, wherein the distal outer strut supports and the distal inner strut supports diverge radially outward from the longitudinal axis as the distal outer strut supports and the distal inner strut supports extend in a distal direction.

11. The valve prosthesis of claim 1, wherein the space defined by each engagement arm and the proximal skirt is sized and configured such that each engagement arm embraces a respective native valve leaflet without folding over the respective native valve leaflet.

12. The valve prosthesis of claim 1, wherein substantially entire portions of the engagement arms diverge radially outward.

13. A valve prosthesis, comprising:

a distal fixation member having exactly three distal outer strut supports and exactly three proximal engagement arms, each engagement arm linking two distal outer strut supports, and each engagement arm having an upwardly concave shape so as to define respective peaks at junctures with the distal outer strut supports and respective troughs between each of respective peaks, wherein the engagement arms diverge radially outward from a longitudinal axis of the valve prosthesis support structure as the engagement arms extend in a proximal direction;

a proximal fixation member having exactly three distal inner strut supports extending from a proximal skirt, wherein the proximal skirt includes a flared distal portion, a narrowed throat portion, and a bulging proximal portion, wherein the distal fixation member is coupled to the proximal fixation member at respective outer and inner strut supports; and

a valve sutured to the proximal fixation member

wherein each engagement arm and the proximal skirt define a space configured to receive a native valve leaflet radially between the respective engagement arm and the proximal skirt, wherein each engagement arm forms a radial outer boundary of the space.

14. The valve prosthesis of claim 13, wherein ends of each engagement arm are at a distance of about 0.5 mm to about 8 mm from ends of the other respective engagement arms.

15. The valve prosthesis support structure of claim 13, wherein the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the proximal fixation member.

16. The valve prosthesis support structure of claim 13, wherein the inner diameter at the level of the inner support struts of the proximal fixation member has a diameter of at least about 23 mm, and the trough of each engagement arm is at a distance of about 1 mm to about 14 mm from the proximal skirt of the proximal fixation member at a distance of about 1 mm to about 10 mm from the proximal skirt of the proximal fixation member.

17. The valve prosthesis of claim 13, wherein the engagement arms are configured such that the troughs of the engagement arms engage surfaces of semilunar sinuses of a native valve complex.

18. The valve prosthesis of claim 13, wherein the engagement arms axially overlap portions of the flared distal portion and the narrowed throat portion of the proximal skirt.

19. The valve prosthesis of claim 13, wherein the bulging proximal portion defines a proximal edge of the valve prosthesis.

20. The valve prosthesis of claim 13, wherein a distal edge of the flared distal portion of the proximal skirt is proximal to a distal edge of the valve prosthesis.

21. The valve prosthesis of claim 20, wherein the distal edge of the flared distal portion of the proximal skirt is substantially and circumferentially aligned with the junctures.

22. The valve prosthesis of claim 13, wherein the distal outer strut supports and the distal inner strut supports diverge radially outward from the longitudinal axis as the distal outer strut supports and the distal inner strut supports extend in a distal direction.

23. The valve prosthesis of claim 13, wherein the space defined by each engagement arm and the proximal skirt is sized and configured such that each engagement arm embraces a respective native valve leaflet without folding over the respective native valve leaflet.

24. The valve prosthesis of claim 13, wherein substantially entire portions of the engagement arms diverge radially outward.