Sinus-engaging valve fixation member

• US 8,414,643 B2
• Filed: 03/23/2007
• Issued: 04/09/2013
• 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: Kilemnik, Ido, Benary, Raphael, Tuval, Yosi
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/726,893
• Publication Number:
  US 20080071368A1
• Time in Patent Office: 2,209 Days
• Field of Search: 623/1.24, 623/2.38, 623 21- 219, 623/1.26
• 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 2/2418 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 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 prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having three semilunar sinuses, three native leaflets, and three native commissures, the prosthesis comprising:

a prosthesis support having a longitudinal axis, wherein the prosthesis support comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures,

wherein the engagement arms extend radially outward from the longitudinal axis,

wherein the engagement arms are shaped so as to define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes,

wherein the engagement arms each define a radial outer boundary of an area configured to receive a respective one of the native leaflets of the native semilunar valve,

wherein, 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, and

wherein the engagement arms are configured and sized such that the trough complexes touch respective transitions between the respective semilunar sinuses and respective native leaflet roots of the native valve complex, upon implantation of the prosthesis.

2. The prosthesis according to claim 1,

wherein the native semilunar valve includes a native aortic valve of the subject,

wherein the semilunar sinuses include respective aortic sinuses, and

wherein, upon implantation of the prosthesis, each of the engagement arms is disposed at least partially within the respective one of the aortic sinuses.

3. The prosthesis according to claim 1,

wherein the native semilunar valve includes a native pulmonary valve of the subject,

wherein the semilunar sinuses include respective pulmonary sinuses, and

wherein, upon implantation of the prosthesis, each of the engagement arms is disposed at least partially within the respective one of the pulmonary sinuses.

4. The prosthesis according to claim 1, wherein the engagement arms are shaped such that each of the peak complexes includes exactly one peak at its respective one of the junctures.

5. The prosthesis according to claim 1, wherein the engagement arms are shaped such that each of the trough complexes includes exactly one trough.

6. The prosthesis according to claim 1, wherein the engagement arms are shaped so as to define exactly one trough between each two of the peak complexes.

7. The prosthesis according to claim 1, wherein the engagement arms are configured such that, during implantation of the prosthesis, the peak complexes self-align with the respective native commissures.

8. The prosthesis according to claim 1, wherein the prosthesis support, upon implantation of the prosthesis, does not press upon the native commissures of the native semilunar valve.

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

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

11. The prosthesis according to claim 1, wherein the prosthesis support is configured, upon implantation thereof, to embrace, without squeezing, leaflets of the native semilunar valve.

12. The prosthesis according to claim 1, wherein the prosthesis support is configured such that, upon implantation of the prosthesis, the prosthesis support does not fold over leaflets of the native semilunar valve.

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

14. The prosthesis according to claim 1, wherein the prosthesis support is configured such that, upon implantation at the native valve complex, the engagement arms are aligned by rotation with respective ones of the semilunar sinuses.

15. The prosthesis according to claim 1, wherein each of the engagement arms is configured to engage a respective one of the semilunar sinuses upon implantation of the prosthesis.

16. The prosthesis according to claim 15, wherein each of the engagement arms is shaped to define a length, parallel to a longitudinal axis of the prosthesis, between (a) at least one of the junctures and (b) a contact point of one of the engagement arms that meets at the juncture with a sinus floor of the respective one of the semilunar sinuses upon implantation of the prosthesis, which length is greater than 6 mm.

17. The prosthesis according to claim 1, further comprising a prosthetic valve having one or more prosthetic leaflets, wherein at least a portion of each of the prosthetic leaflets is configured to assume a closed position during diastole and an open position during systole, and wherein the at least a portion is not directly coupled to any of the engagement arms.

18. The prosthesis according to claim 17, wherein the prosthetic valve is coupled to the support structure such that at least 50% of an axial length of the prosthetic leaflets is distal to the native valve leaflets of the native semilunar valve, upon implantation of the prosthesis.

19. The prosthesis according to claim 1, wherein at least one engagement arms comprises an upwardly concave portion, wherein the upwardly concave portion is shaped so as to curve outward from the longitudinal axis in a radial direction when the prosthesis support is in an expanded state.

20. The prosthesis according to claim 1,

wherein the support structure is configured to serve as a distal fixation member,

wherein the prosthesis support further comprises a proximal fixation member, and

wherein the proximal fixation member and the engagement arms of the distal fixation member are configured to axially sandwich the native valve complex from ventricular and downstream sides thereof, respectively, upon implantation of the prosthesis.