Leaflet-sensitive valve fixation member

• US 8,876,894 B2
• Filed: 03/23/2007
• Issued: 11/04/2014
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Kilemnik, Ido, Benary, Raphael
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/726,863
• Publication Number:
  US 20080071361A1
• Time in Patent Office: 2,783 Days
• Field of Search: 623 124- 126, 623 214- 219, 623 238- 241
• US Class Current: 623/2.18
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and to apply a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof. The prosthesis is configured, upon implantation thereof, to embrace, without squeezing, leaflets of the native semilunar valve. Other embodiments are also described.

Claims

1. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the prosthesis comprising:

a distal fixation member including exactly three engagement arms, wherein each of the engagement arms is configured to extend into a respective sinus of a heart when the prosthesis is implanted in a native valve complex, wherein the distal fixation member has an upstream end and a downstream end, the upstream end being configured to be positioned closer to a ventricle of a subject when the prosthesis is implanted in a subject, and wherein the distal fixation member is configured to apply a first axial force directed toward a ventricle of the subject;

a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of a native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof; and

a replacement cardiac valve, wherein the replacement cardiac valve includes commissures, and wherein the commissures are attached to the downstream end of the distal fixation member.

2. The apparatus according to claim 1, wherein the prosthesis is configured, upon implantation thereof, to gently embrace, without squeezing, leaflets of a native semilunar valve.

3. The apparatus according to claim 1, wherein the distal fixation member is configured to be positioned in an ascending aorta.

4. The apparatus according to claim 1, wherein the distal fixation member is configured to be positioned in a pulmonary trunk.

5. The apparatus according to claim 1, wherein the prosthesis is configured such that any radial force applied by the prosthesis outwardly against a native semilunar valve is insufficient by itself to chronically maintain the prosthesis in position with respect to a native valve complex under conditions of normal cardiac motion.

6. The apparatus according to claim 1, wherein the prosthesis is configured to apply the first axial force such that a ratio of (a) the first axial force to (b) a radial force applied outwardly by the prosthesis against a native semilunar valve is greater than 1.5:

1.

7. The apparatus according to claim 1, wherein the prosthesis is configured to apply the second axial force such that a ratio of (a) the second axial force to (b) a radial force applied outwardly by the prosthesis against a native semilunar valve is greater than 1.5:

1.

8. The apparatus according to claim 1, wherein the prosthesis is configured to apply a radial force of less than 0.5 pounds outwardly against a native semilunar valve.

9. The apparatus according to claim 1, wherein the distal fixation member does not press upon native valve commissures of a native semilunar valve upon implantation of the prosthesis.

10. The apparatus according to claim 1, wherein the prosthesis is configured to apply the first axial force with a force of at least 40 g during diastole.

11. The apparatus according to claim 1, wherein the prosthesis is configured to apply the second axial force with a force of at least 1 g during systole.

12. The apparatus according to claim 1, wherein the prosthesis is configured to apply the second axial force with a force of at least 5 g during systole.

13. The apparatus according to claim 1, wherein the distal fixation member is configured such that it does not fold over leaflets of a native semilunar valve upon implantation of the prosthesis.

14. The apparatus according to claim 1, wherein the prosthesis is configured to less than fully open leaflets of a native valve complex when the prosthesis is implanted at the native valve complex.

15. The apparatus according to claim 1, wherein the replacement cardiac valve is configured to assume a closed position during diastole and an open position during systole.

16. The apparatus according to claim 15, wherein the replacement cardiac valve comprises a collapsible pliant material, configured to assume the open and closed positions.

17. The apparatus according to claim 15, wherein the distal and proximal fixation members and the replacement cardiac valve are configured to define a single flow field through the distal and proximal fixation members and the replacement cardiac valve.

18. The apparatus according to claim 15, wherein the distal and proximal fixation members and the replacement cardiac valve are configured to define a plurality of flow fields through the distal and proximal fixation members and the replacement cardiac valve.

19. The apparatus according to claim 15, wherein the replacement cardiac valve comprises one or more prosthetic leaflets, and wherein the replacement cardiac valve is coupled to the prosthesis such that at least 50% of an axial length of the prosthetic leaflets is distal to native valve leaflets of a native semilunar valve upon implantation of the prosthesis.