Assessing the location and performance of replacement heart valves

• US 9,005,273 B2
• Filed: 04/04/2007
• Issued: 04/14/2015
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Brandt, Brian D., Morejohn, Dwight P., Haug, Ulrich R., Dueri, Jean-Pierre, Valencia, Hans F., Geshlider, Robert A., Krolik, Jeff
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/732,906
• Publication Number:
  US 20070244552A1
• Time in Patent Office: 2,932 Days
• Field of Search: 623/1.26
• US Class Current: 623/1.26
• 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 2/2439 Expansion controlled by filaments
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

Methods and devices for assessing the operation of a replacement heart valve. The method includes endovascularly delivering a replacement heart valve to a vicinity of a heart valve in an unexpanded configuration, and assessing the operation of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve. Methods and devices for assessing the location of a replacement heart valve. The method includes endovascularly delivering a replacement heart valve to a vicinity of the heart valve in an unexpanded configuration, expanding the replacement heart valve to a partially deployed configuration, and assessing the location of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve.

Claims

1. A method of assessing the operation of a replacement heart valve, the method comprising:

endovascularly delivering a replacement heart valve to a vicinity of a heart valve in an unexpanded configuration; and

assessing the operation of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve.

2. The method of claim 1 wherein the replacement heart valve comprises a proximal end and a distal end, and wherein assessing the operation of the replacement heart valve comprises assessing the operation of the heart valve when the proximal end of the replacement heart valve is not engaging native tissue.

3. The method of claim 2 wherein delivering comprises delivering the replacement heart valve within a delivery catheter, and wherein assessing the operation of the replacement heart valve comprises assessing the operation of the replacement heart valve while the proximal end of the replacement heart valve is disposed within the delivery sheath.

4. The method of claim 1 wherein assessing the operation of the replacement heart valve comprises controlling blood flow through the replacement heart valve.

5. The method of claim 1 wherein expanding the replacement heart valve to a fully expanded configuration comprises expanding the replacement heart valve to a partially deployed configuration.

6. The method of claim 5 wherein expanding the replacement heart valve to a partially deployed configuration comprises allowing the replacement heart valve to self-expand to the partially deployed configuration.

7. The method of claim 5 wherein assessing the operation of the replacement heart valve comprises controlling blood flow through the replacement heart valve.

8. The method of claim 7 wherein assessing the operation of the replacement heart valve occurs after the replacement heart has self-expanded to the partially deployed configuration and before the replacement heart valve is expanded to the fully expanded configuration.

9. The method of claim 1 wherein assessing the operation of the replacement heart valve comprises visually observing the operation of the replacement heart valve.

10. The method of claim 9 wherein visually observing comprises visually observing with at least one medical imaging technique.

11. The method of claim 10 wherein assessing the operation of the replacement heart valve comprises assessing the blood flow through or around the replacement heart valve.

12. The method of claim 11 wherein assessing the blood flow through or around the replacement heart valve comprises assessing at least one of effective orifice, ejection fraction, and regurgitation.

13. The method of claim 11 wherein assessing the blood flow through or around the replacement heart valve comprises assessing at least one of valve leakage, valve positioning, and valve sizing.

14. The method of claim 10 wherein assessing the operation of the replacement heart valve comprises using an injectable marker.

15. The method of claim 1 further comprising assessing the function of a mitral valve.

16. The method of claim 1, further comprising reassessing the operation of the replacement heart valve after expanding the replacement heart valve to the fully expanded configuration.

17. The method of claim 1, further comprising repositioning the replacement heart valve after assessing the operation of the replacement heart valve, and further comprising reassessing the operation of the replacement heart valve after repositioning the replacement heart valve.

18. The method of claim 17 wherein repositioning the replacement heart valve comprises collapsing and re-expanding the replacement heart valve.

19. The method of claim 1 further comprising assessing the location of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve.

20. The method of claim 1 wherein assessing the operation of the replacement heart valve occurs before the replacement heart valve self-expands to an at-rest configuration.