Sinus-engaging valve fixation member

• US 9,301,834 B2
• Filed: 10/16/2009
• Issued: 04/05/2016
• 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): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US12/580,642
• Publication Number:
  US 20100131054A1
• Time in Patent Office: 2,363 Days
• Field of Search: 623/1.26, 623/1.24, 623 21- 219, 623 238- 241
• 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 2/2418 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 medical device for treating a diseased native heart valve having sinuses and native leaflets, comprising:

a prosthetic valve; and

a metallic support structure for supporting the prosthetic valve, the support structure comprising;

a first plurality of arms configured to be respectively positioned within the sinuses of the diseased native heart valve, wherein each of the first plurality of arms includes a substantially U-shaped or V-shaped structure having a downstream open end and an upstream closed end, and wherein each of the first plurality of arms is biased to pivot radially outward from a longitudinal axis of the medical device without outside forces acting upon the first plurality of arms, and

a second plurality of arms, wherein each of the second plurality of arms includes a substantially U-shaped or V-shaped structure,

wherein each of the first plurality of arms is associated with each of the second plurality of arms such that a native leaflet of the native heart valve is radially between each associated first arm and second arm when the medical device is implanted such that each first arm is radially outside a native leaflet of the native heart and each second arm is radially inside and in contact with a native leaflet of the native heart, and

wherein each downstream end portion of a respective first arm is joined to a downstream end portion of an associated second arm by a strut support extending substantially in the longitudinal direction of the prosthesis.

2. The medical device of claim 1, in which the support structure is configured to expand from a first collapsed mode when the medical device is being introduced into the patient'"'"'s body to a second expanded mode when the medical device is in the implanted state.

3. The medical device of claim 1, in which the support structure is made from a shape memory material so that the support structure can be expanded from a collapsed shape to an expanded shape under the effect of an external stimulus.

4. The medical device of claim 1, in which the first plurality of arms is configured to be expandable from a first collapsed mode to a second expanded mode independently from the second plurality of arms.

5. The medical device of claim 1, in which the first plurality of arms are configured to expand from a collapsed mode to an expanded form and be positioned within the sinuses of the diseased native heart valve.

6. The medical device of claim 1, wherein:

each of the first plurality of arms defines a first trough complex;

each of the second plurality of arms defines a second trough complex; and

each first trough complex of the first plurality of arms is axially aligned with a second trough complex of a respective arm of the second plurality of arms.

7. The medical device of claim 1, wherein:

each of the first plurality of arms defines a first trough complex;

each of the second plurality of arms defines a second trough complex; and

each first trough complex of the first plurality of arms is axially between a downstream end portion of a respective associated arm of the second plurality of arms and a trough complex of the respective associate arm of the second plurality of arms.

8. The medical device of claim 1, wherein the first plurality of arms consists essentially of three arches, and the second plurality of arms consists essentially of three arches.

9. The medical device of claim 1, wherein the first plurality of arms and the second plurality of arms are part of a single-piece construction.

10. The medical device of claim 1, wherein each of the first plurality of arms consists essentially of one U-shaped or V-shaped structure.

11. The medical device of claim 1, wherein the medical device is configured to be implanted using a procedure selected from the group consisting of a transapical procedure, a transaortic procedure, a transseptal procedure, a transarterial procedure, a transcardiac procedure, a percutaneous procedure, and an endovascular procedure.

12. The medical device of claim 1, wherein the native heart valve is a mitral valve, an aortic valve, a pulmonary valve, or a tricuspid valve.

13. A support structure comprising:

a plurality of first elements each including first and second arm segments connected at respective proximal ends thereof to one another, forming a plurality of first closed ends, and connected at respective distal ends thereof to a respective first or second arm segment of an adjacent first element, forming a plurality of first joints wherein each of the first elements is biased to pivot radially outward from a longitudinal axis of the medical device without outside forces acting upon the first elements; and

a plurality of second elements each including third and fourth arm segments connected at respective proximal ends thereof to one another, forming a plurality of second closed ends, and connected at respective distal ends thereof to a respective third or fourth arm segment of an adjacent second element, forming a plurality of second joints;

wherein;

each of the plurality of first elements is joined to a respective one of the plurality of second elements via a strut support; and

each of the plurality of first closed ends is axially between the plurality of second closed ends and the plurality of the second joints,

wherein the support structure is metallic.

14. The support structure of claim 13, wherein each of the first and second elements generally forms an arch having a generally rounded tip portion formed at a respective one of the plurality of first and second closed ends.

15. The support structure of claim 13, wherein the support structure is configured to be expandable from a collapsed mode to an expanded mode.

16. The support structure of claim 13, wherein the plurality of first elements includes three first elements.

17. The support structure of claim 13, wherein the support structure is made from a shape-memory alloy.

18. The support structure of claim 13, wherein the plurality of first elements consists essentially of three arches, and the plurality of second elements consists essentially of three arches.

19. The medical device of claim 13, wherein each of the plurality of first closed ends is axially aligned with a respective second closed end of the plurality of closed ends.

20. The medical device of claim 13, wherein each of the plurality of first elements is configured to be positioned on a first side of native leaflets of a native heart valve;

and wherein each of the plurality of second elements is configured to be positioned on a second side of the native leaflets such that the native valve leaflets are positioned radially inward of at least a portion of the plurality of first elements and positioned radially outward of at least a portion of the plurality of second elements when the medical device is implanted.

21. The medical device of claim 20, wherein the native heart valve is a mitral valve, an aortic valve, a pulmonary valve, or a tricuspid valve.

22. The medical device of claim 13, wherein the medical device is configured to be implanted using a procedure selected from the group consisting of a transapical procedure, a transaortic procedure, a transseptal procedure, a transarterial procedure, a transcardiac procedure, a percutaneous procedure, and an endovascular procedure.

23. A medical device for treating a diseased native heart valve having native leaflets and sinuses, comprising:

a prosthetic valve;

a support structure for supporting the prosthetic valve, the support structure comprising;

a first plurality of arms configured to be respectively positioned within the sinuses of the native heart valve on a radially outward side of the native valve leaflets, wherein each of the first plurality of arms is biased to pivot radially outward from a longitudinal axis of the medical device without outside forces acting upon the first plurality of arms;

a second plurality of arms configured to be positioned on a radial inward side of the native leaflets; and

a plurality of strut supports joining the first plurality of arms to the second plurality of arms;

wherein each of the first plurality of arms forms a first distal open end and a first proximal closed end, each of the first plurality of arms is connected at the first distal open end thereof to a respective strut support, such that each of the first plurality of arms defines a first single trough between two adjacent strut supports; and

wherein each of the second plurality of arms forms a second distal open end and a second proximal closed end, each of the second plurality of arms is connected at the second distal open end thereof to a respective strut support, such that each of the second plurality of arms defines a second single trough between two adjacent strut supports.

24. The medical device of claim 23, wherein the first plurality of arms includes a substantially U-shaped or V-shaped structure.

25. The medical device of claim 23, wherein the second plurality of arms includes a substantially U-shaped or V-shaped structure.

26. The medical device of claim 23, wherein the medical device is configured to expand from a first collapsed mode when the medical device is being introduced into the patient'"'"'s body and to a second expanded mode when the medical device is in the implanted state.

27. The medical device of claim 23, wherein the support structure is made from a shape memory material so that the medical device can be expanded from a collapsed shape to an expanded shape under the effect of an external stimulus.

28. The medical device of claim 23, wherein the first plurality of arms consists essentially of three arches, and the second plurality of arms consists essentially of three arches.

29. The medical device of claim 23, wherein the medical device is configured to be implanted using a procedure selected from the group consisting of a transapical procedure, a transaortic procedure, a transseptal procedure, a transarterial procedure, a transcardiac procedure, a percutaneous procedure, and an endovascular procedure.

30. The medical device of claim 23, wherein the native heart valve is a mitral valve, an aortic valve, a pulmonary valve, or a tricuspid valve.