IMPLANT IMPLANTATION UNIT AND PROCEDURE FOR IMPLANTING THE UNIT

• US 20100070027A1
• Filed: 03/19/2009
• Published: 03/18/2010
• Est. Priority Date: 08/03/2001
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc., Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Bonhoeffer, Philipp, Boudjemline, Younes
• Granted Patent: US 8,206,437 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

The implant implantation unit (2), at a determined position in the tubular element (51) with a wall comprising a cavity (50), is pushed there by a catheter (60) and the unit comprises deformable feelers (31) to, under the control of remote activation elements (42), change from a stowed form to a deployed functional form, to detect the cavity (50) and position itself there with reference to the position of the cavity.

Claims

1-10. -10. (canceled)

11. A method comprising:

providing a semilunar valve prosthesis;

placing the prosthesis in a body of a subject; and

determining a correct rotational disposition of the prosthesis with respect to a semilunar valve site based on tactile feedback.

12. The method according to claim 11, wherein providing the semilunar valve prosthesis comprises providing an aortic valve prosthesis.

13. The method according to claim 11, wherein placing the prosthesis comprises placing the prosthesis without using any imaging techniques.

14. A method comprising:

placing a semilunar valve prosthesis at a native semilunar valve site; and

causing the prosthesis to self-align with respect to the site by gently rotating the valve prosthesis.

15. The method according to claim 14, wherein the semilunar valve prosthesis includes an aortic valve prosthesis, wherein the native semilunar valve site includes a native aortic valve site, and wherein placing comprises placing the aortic valve prosthesis at the native aortic valve site.

16. The method according to claim 14, wherein causing the prosthesis to self-align comprises moving the prosthesis in an axial direction defined with respect to an axis of a downstream artery, while gently rotating the prosthesis.

17. The method of claim 16, wherein the artery comprises an ascending aorta.

18. The method according to claim 14, wherein gently rotating the prosthesis comprises moving the prosthesis in a proximal direction such that contact of the prosthesis with tissue of the native semilunar valve site causes the rotating.

19. The method according to claim 14, wherein placing the prosthesis and causing the prosthesis to self-align comprise placing the prosthesis and causing the prosthesis to self-align without using any imaging techniques.

20. The method according to claim 14, wherein causing the prosthesis to self-align comprises verifying that the prosthesis is properly aligned with respect to the semilunar valve site by attempting to rotate the prosthesis with respect to the semilunar valve site.

21. The method according to claim 14, wherein the prosthesis is shaped so as to define one or more proximal engagement arms that are configured to be positioned at least partially within respective semilunar sinuses of the native semilunar valve site, and wherein causing the prosthesis to self-align comprises causing the engagement arms to self-align with respect to the respective semilunar sinuses.

22. The method according to claim 21, wherein gently rotating the prosthesis comprises moving the prosthesis in a proximal direction such that contact of one or more of the engagement arms with tissue of the native semilunar valve site causes the rotating.

23. The method according to claim 21, wherein causing the prosthesis to self-align comprises verifying that the engagement arms are properly placed with respect to the semilunar valve site by attempting to rotate the engagement arms with respect to the semilunar valve site.

24. A method, comprising:

placing a semilunar valve prosthesis at a native semilunar valve site, the prosthesis shaped so as to define one or more proximal engagement arms;

attempting to position the engagement arms at least partially within respective semilunar sinuses of the native semilunar valve site; and

verifying that the engagement arms are properly placed with respect to the semilunar valve site by attempting to rotate the engagement arms with respect to the semilunar valve site.

25. The method according to claim 24, wherein the semilunar valve prosthesis includes an aortic valve prosthesis, wherein the native semilunar valve site includes a native aortic valve site, and wherein placing comprises placing the aortic valve prosthesis at the native aortic valve site.

26. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the prosthesis comprising a support structure, which is configured such that a correct rotational disposition of the prosthesis with respect to the native semilunar valve can be determined based on tactile feedback.

27. Apparatus comprising 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 and three native commissures, the prosthesis comprising a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures,

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, and

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 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.

28. The apparatus according to claim 27, 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.

29. The apparatus according to claim 27, wherein the engagement arms are shaped such that each of the peak complexes includes exactly one peak at its respective one of the junctures.

30. The apparatus according to claim 27, wherein the engagement arms are shaped such that each of the trough complexes includes exactly one trough.

31. The apparatus according to claim 27, wherein the engagement arms are shaped so as to define exactly one trough between each two of the peak complexes.

32. The apparatus according to claim 27, wherein the engagement arms are configured to touch respective transitions between the respective semilunar sinuses and respective native leaflet roots of the native valve complex, upon implantation of the prosthesis.

33. The apparatus according to claim 27, wherein the valve prosthesis support, upon implantation of the prosthesis, does not press upon the native commissures of the native semilunar valve.

34. The apparatus according to claim 27, wherein the prosthesis is configured to apply a radial force outwardly against the native semilunar valve.

35. The apparatus according to claim 27, wherein the prosthesis is configured, upon implantation thereof, to embrace, without squeezing, leaflets of the native semilunar valve.

36. The apparatus according to claim 27, wherein the valve prosthesis support is configured such that, upon implantation of the prosthesis, the valve prosthesis support does not fold over leaflets of the native semilunar valve.

37. The apparatus according to claim 27, wherein the prosthesis 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.

38. The apparatus according to claim 27, wherein each of the engagement arms is configured to engage a respective one of the semilunar sinuses upon implantation of the prosthesis.

39. The apparatus according to claim 37, 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 a distance of a native valve leaflet sinus to a free end of the native valve leaflet.

40. The apparatus according to claim 27, wherein the prosthesis comprises a prosthetic valve comprising 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.

41. The apparatus according to claim 40, wherein the prosthetic valve is coupled to the support structure such that at least a portion of an axial length of the prosthetic leaflets is distal to native valve leaflets of the native semilunar valve, upon implantation of the prosthesis.

42. The apparatus according to claim 27, wherein the support structure is configured to serve as a distal fixation member, wherein the valve prosthesis support 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.

43. A method for implanting a prosthesis at a native semilunar valve of a native valve complex of a subject, the native valve complex having three semilunar sinuses and three native commissures, the method comprising:

providing the prosthesis including a valve prosthesis support, which valve prosthesis support includes a support structure comprising exactly three engagement arms that meet one another at three respective junctures, 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; and

implanting the prosthesis such that each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, each of the peak complexes is disposed distal to 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.