Markers for prosthetic heart valves

• US 9,089,422 B2
• Filed: 01/23/2009
• Issued: 07/28/2015
• Est. Priority Date: 01/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R., Tabor, Charles
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/358,765
• Publication Number:
  US 20090192591A1
• Time in Patent Office: 2,377 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.11, 623/2.18, 623/1.34, 623/1.43
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A replacement prosthetic heart valve for engagement with a structure of an original prosthetic heart valve that includes at least one visually detectable marker. The replacement heart valve includes a stent structure having a generally tubular body portion and at least one visually detectable marker on a portion of the stent structure, and at least two leaflets attached within the interior area of the tubular body portion of the stent structure. At least one visually detectable marker of the stent structure is alignable with at least one visually detectable marker of the original prosthetic heart valve.

Claims

1. A replacement prosthetic heart valve for engagement with a structure of an original prosthetic heart valve that comprises a tubular base from which multiple commissure posts extend in an axial direction, wherein at least one of the commissure posts comprises at least one visually detectable commissure marker, the replacement prosthetic heart valve comprising:

a stent structure comprising;

a generally tubular body portion having a longitudinal axis; and

at least one visually detectable and directionally distinguishable marker on a portion of the stent structure; and

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

wherein the at least one visually detectable and directionally distinguishable marker of the stent structure is positionable relative to the at least one visually detectable commissure marker of the original prosthetic heart valve and is directionally distinguishable such that the directionally distinguishable marker appears differently if the directionally distinguishable marker is on a portion of the generally tubular portion towards the viewer than if the directional distinguishable marker is on a portion of the generally tubular portion away from the viewer;

wherein the visually detectable and directionally distinguishable marker of the replacement heart valve is radiopaque; and

wherein the visually detectable and directionally distinguishable marker of the replacement heart valve is c-shaped, wherein the c-shape is transverse to the longitudinal axis and configured to indicate a rotational orientation around the longitudinal axis of the replacement heart valve.

2. The replacement heart valve of claim 1, wherein at least one visually detectable commissure marker of the original heart valve is directionally distinguishable.

3. The replacement heart valve of claim 2, wherein the at least one marker of the replacement heart valve comprises indicia that is the same as the at least one commissure marker of the original prosthetic heart valve.

4. The replacement heart valve of claim 1, wherein at least one of the visually detectable markers is visible with fluoroscopic visualization techniques.

5. The replacement heart valve of claim 1, wherein the replacement heart valve further comprises at least one visually detectable skirt that extends around at least a portion of the generally tubular body portion.

6. The replacement heart valve of claim 5, wherein the at least one skirt comprises a deformable sealing skirt, wherein deformation of the sealing skirt is visually detectable.

7. The replacement heart valve of claim 1, wherein the at least one visually detectable marker of the replacement prosthetic valve comprises multiple markers.

15. The replacement heart valve of claim 1, wherein the visually detectable and directionally distinguishable marker of the replacement heart valve extends entirely through a non-radiopaque portion of the stent structure.

8. A replacement prosthetic heart valve having a longitudinal axis and associated with an original heart valve, wherein the original valve comprises a tubular base from which multiple commissure posts extend in an axial direction and at least one visually detectable marker associated therewith, and wherein the replacement heart valve comprises at least one visually detectable and directionally distinguishable marker that is c-shaped, wherein the c-shape is transverse to the longitudinal axis and alignable with the at least one marker of the original heart valve and directionally distinguishable such that the visually detectable and directionally distinguishable marker appears differently if the visually detectable and directionally distinguishable marker is on a portion of the replacement heart valve towards the viewer than if the visually detectable and directionally distinguishable marker is on a portion of the replacement heart valve away from the viewer, wherein the visually detectable and directionally distinguishable marker of the replacement heart valve is radiopaque, and wherein the visually detectable and directionally distinguishable marker of the replacement heart valve is configured to indicate a rotational orientation around the longitudinal axis of the replacement heart valve.

9. The combination of claim 8, wherein the at least one visually detectable marker of the original heart valve comprises at least one of an annular marker, a one sinus marker, and a commissure marker associated with at least one of the commissure posts.

10. The combination of claim 9, wherein at least one annular marker, or at least one sinus marker, or at least one commissure marker is associated with the original heart valve.

11. The combination of claim 9, wherein at least one annular marker is associated with the original heart valve, and wherein the at least one visually detectable marker of the replacement heart valve comprises a skirt comprising at least one skirt marker for alignment with the at least one annular marker associated with the original heart valve.

12. The combination of claim 9, wherein the at least one visually detectable marker of the replacement heart valve comprises at least one commissure marker for alignment with at least one commissure marker associated with the original heart valve.

13. The combination of claim 8, wherein the at least one visually detectable marker of the replacement valve comprises at least one deformable sealing skirt, wherein deformation of the sealing skirt is visually detectable.

16. The combination of claim 8, wherein the visually detectable and directionally distinguishable marker of the replacement heart valve extends entirely through a non-radiopaque portion of the replacement heart valve.

14. A method of implanting a replacement prosthetic heart valve within an original prosthetic heart valve comprising a tubular base from which multiple commissure posts extend in an axial direction, wherein at least one of the commissure posts comprises at least one visually detectable commissure marker, the method comprising:

positioning a replacement prosthetic heart valve in an internal area defined by a generally tubular structure of the original prosthetic heart valve, wherein the replacement heart valve comprises;

a stent structure comprising;

a generally tubular body portion having a longitudinal axis; and

at least one visually detectable and directionally distinguishable marker on a portion of the stent structure, that is c-shaped, wherein the c-shape is transverse to the longitudinal axis and directionally distinguishable such that the visually detectable and directionally distinguishable marker appears differently if the visually detectable and directionally distinguishable marker is on a portion of the generally tubular portion towards the viewer than if the visually detectable and directionally distinguishable marker is on a portion of the generally tubular portion away from the viewer; and

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

adjusting the location of the replacement heart valve by aligning at least one visually detectable marker of the replacement heart valve with at least one visually detectable commissure marker of the original heart valve,

wherein the visually detectable and directionally distinguishable marker of the replacement heart valve is radiopaque, and

wherein the visually detectable and directionally distinguishable marker of the replacement heart valve is configured to indicate a rotational orientation around the longitudinal axis of the replacement heart valve.

17. The method of claim 14, wherein the visually detectable and directionally distinguishable marker of the replacement heart valve extends entirely through a non-radiopaque portion of the stent structure.