Replacement prosthetic heart valves and methods of implantation

• US 20080215144A1
• Filed: 02/15/2008
• Published: 09/04/2008
• Est. Priority Date: 02/16/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R., Morrow, Joseph C.
• Granted Patent: US 7,871,436 B2
• Time in Patent Office: Days
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve, the replacement heart valve including a stent structure and at least two leaflets attached within the interior area of a tubular body portion of the stent structure. The stent structure includes a generally tubular body portion having an interior area, at least two upper flange portions for positioning at an outflow end of the previously implanted heart valve, wherein the upper flange portions extend radially outward from the tubular body portion and are biased toward an inflow end of the replacement heart valve, and at least one lower flange portion for positioning at an inflow end of the previously implanted heart valve, wherein the lower flange portions extend radially outward from the tubular body portion and are biased toward an outflow end of the replacement heart valve.

Claims

1. A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve, the replacement heart valve comprising:

a stent structure comprising;

a generally tubular body portion having an interior area;

at least two upper flange portions for positioning at an outflow end of the previously implanted heart valve, wherein the upper flange portions extend radially outward from the tubular body portion and are biased toward an inflow end of the replacement heart valve; and

at least one lower flange portion for positioning at an inflow end of the previously implanted heart valve, wherein the lower flange portions extend radially outward from the tubular body portion and are biased toward an outflow end of the replacement heart valve; and

at least two leaflets attached within the interior area of the tubular body portion of the stent structure.

2. The replacement heart valve of claim 1, wherein the tubular body portion further comprises at least one upper vertical member extending toward the outflow end of the replacement heart valve and configured for contacting an internal area of a stent post of the previously implanted prosthetic heart valve, and wherein each upper vertical member is positioned circumferentially between two adjacent upper flange portions.

3. The replacement heart valve of claim 2, wherein the tubular body portion further comprises at least one lower vertical member extending toward the inflow end of the replacement heart valve and configured for contacting an internal area of a stent ring of the previously implanted prosthetic heart valve, and wherein each lower vertical member is positioned circumferentially between two adjacent lower flange portions.

4. The replacement heart valve of claim 2, wherein the number of upper vertical members is the same as the number of stent posts of the previously implanted prosthetic heart valve.

5. The replacement heart valve of claim 2, wherein at least one of the upper vertical members further comprises a distal end having an eyelet for engagement with a portion of a delivery system.

6. The replacement heart valve of claim 1, wherein at least one of the upper and lower flange portions is self-expandable from a collapsed position to an expanded position in response to removal of an external compressive force.

7. The replacement heart valve of claim 1, wherein the stent structure comprises at least one portion that is self-expandable with the removal of an external compressive force and at least one portion that is expandable with the application of an outward radial force.

8. The replacement heart valve of claim 7, wherein the self-expandable portion of the stent structure comprises at least one of the upper and lower flange portions.

9. The replacement heart valve of claim 1, wherein each of the upper flange portions is configured for positioning in a space between two adjacent stent posts of the previously implanted prosthetic heart valve.

10. The replacement heart valve of claim 2, wherein the tubular body portion further comprises at least one upper connecting member extending between distal ends of first and second adjacent upper vertical members.

11. The replacement heart valve of claim 1, wherein the tubular body portion further comprises at least one upper vertical member extending toward the outflow end of the replacement heart valve and configured for contacting an internal area of a stent post of the previously implanted prosthetic heart valve, and wherein at least two upper flange portions are positioned circumferentially between two adjacent upper vertical members.

12. The replacement heart valve of claim 1, wherein at least one of the upper and lower flange portions comprises a visually detectable marker.

13. The replacement heart valve of claim 1, further comprising a sealing gasket surrounding at least a portion of a perimeter of the generally tubular body.

14. A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve, the replacement heart valve comprising:

a stent structure comprising;

a generally tubular body portion having an interior area;

at least one upper vertical member extending toward the outflow end of the replacement heart valve and configured for contacting an internal surface of a stent post of the previously implanted prosthetic heart valve; and

at least one stent post engaging structure extending outwardly from the body portion for engaging with an outer surface of a stent post of the previously implanted prosthetic heart valve.

15. The replacement heart valve of claim 14, wherein the stent structure further comprises at least one lower vertical member extending toward the inflow end of the replacement heart valve.

16. The replacement heart valve of claim 14, wherein the stent structure further comprises at least one lower flange member extending outwardly from the tubular body portion and biased toward an outflow end of the replacement heart valve.

17. The replacement heart valve of claim 16, wherein the stent structure further comprises at least one leaflet engaging structure for engaging with leaflet material from the previously implanted prosthetic heart valve, wherein the at least one leaflet engaging structure is positioned circumferentially between two adjacent lower flange members for contact with an internal area of a stent ring of the previously implanted prosthetic heart valve.

18. The replacement heart valve of claim 14, wherein at least one stent post engaging structure comprises a visually detectable marker.

19. The replacement heart valve of claim 14, further comprising a sealing gasket surrounding at least a portion of a perimeter of the generally tubular body portion.

20. A method of implanting a replacement prosthetic heart valve within a previously implanted prosthetic heart valve, the method comprising:

positioning a replacement prosthetic heart valve in an internal area defined by the structure of the previously implanted prosthetic heart valve, wherein the replacement heart valve comprises;

a stent structure comprising;

a generally tubular body portion having an interior area;

at least two upper flange portions for positioning at an outflow end of the previously implanted heart valve, wherein the upper flange portions extend outwardly from the tubular body portion and are biased toward an inflow end of the replacement heart valve; and

at least one lower flange portion for positioning at the inflow end of the previously implanted heart valve, wherein the lower flange portions extend outwardly from the tubular body portion and are biased toward an outflow end of the replacement heart valve; and

at least two leaflets attached within the interior area of the tubular body portion;

wherein a first portion of the stent structure is self-expandable with the removal of an external compressive force and a second portion of the stent structure is expandable with the application of an internal radial force;

removing the external compressive force on the stent structure to allow the first portion of the stent structure to radially expand; and

applying an internal radial force to the stent structure to expand the second portion of the stent.