Methods of measuring heart valve annuluses for valve replacement

• US 8,449,625 B2
• Filed: 10/27/2009
• Issued: 05/28/2013
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Campbell, Louis A., Oba, Travis Z., Pintor, Rafael
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US12/606,945
• Publication Number:
  US 20110098602A1
• Time in Patent Office: 1,309 Days
• Field of Search: 600/587, 600590-591, 623/2, 623/900, 623 21- 242, 623902-904, 623912-913, 623/918, 623/920, 623/922, 604/104, 606/194, 33511-512
• US Class Current: 623/904
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 90/08 Accessories or related features not otherwise provided for
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A device for measuring an expanded internal orifice of a patient includes an orifice-expanding device, a pressure measuring device, and a size-measuring device. The size-measuring device measures a dimension of the orifice after it has been expanded by the orifice-expanding device.

Claims

1. A method of sizing a heart valve annulus for implant of a prosthetic heart valve, comprising:

accessing a patient'"'"'s heart valve annulus;

placing an orifice-expanding device of a sizing apparatus into the annulus;

expanding the orifice-expanding device to a desired pressure against the annulus such that the annulus expands, wherein the desired pressure is between about 250 mmHg and 500 mmHg;

measuring a dimension of the expanded annulus; and

selecting a prosthetic heart valve based on the measured dimension of the annulus.

2. The method of claim 1, wherein the method further comprises implanting the heart valve in the annulus.

3. The method of claim 1, wherein the act of measuring a dimension of the expanded annulus is accomplished while the orifice-expanding device is in the expanded annulus.

4. The method of claim 3, wherein the act of measuring a dimension of the expanded annulus comprises reading visual indicia on the sizing apparatus and recording the measured dimension.

5. The method of claim 3, wherein the sizing apparatus comprises a coiled member surrounding at least a portion of the orifice-expanding device and which uncoils upon expansion of the orifice-expanding device, the coiled member having a first end and a second end, the first end being fixed relative to the orifice-expanding device, the coiled member having visual indicia on a surface of the coiled member, and wherein the act of measuring a dimension of the expanded annulus comprises observing the position of the second end of the coiled member relative to the visual indicia.

6. The method of claim 3, wherein the sizing apparatus comprising an elongated shaft and a movable indicator coupled to the orifice-expanding device and operable to move longitudinally of the shaft upon expansion of the orifice-expanding device, wherein the act of measuring a dimension of the expanded annulus comprises observing the position of the movable indicator relative to a location on the shaft.

7. The method of claim 1, wherein the act of measuring a dimension of the expanded annulus is accomplished after the orifice-expanding device is removed from the body.

8. The method of claim 7, further comprising retaining the orifice-expanding device in an expanding state after the act of expanding the orifice-expanding device and removing the orifice-expanding device from the body in its expanded state in order to measure the dimension of the expanded annulus.

9. The method of claim 1, wherein the desired pressure exerted by the orifice-expanding device is at least the physiological pressure experienced by the annulus at its greatest diameter during the cardiac cycle.

10. The method according to claim 1, wherein the orifice-expanding device is a balloon and the act of expanding comprises inflating the balloon to expand the annulus.

11. The method according to claim 1, wherein the orifice-expanding device comprises one or more strain gauges and the method further comprises measuring the strain on the orifice-expanding device when it is expanded and determining the pressure exerted against the annulus by the orifice-expanding device from the measured strain.

12. The method according to claim 1, wherein the orifice-expanding device comprises a non-cylindrical outer surface that generally corresponds to the shape of the annulus.

13. The method of claim 1, wherein the desired pressure is about 350 mmHg.

14. The method of claim 1, wherein the desired pressure approximates the pressure the annulus will experience during expansion of an expandable prosthetic valve.

26. The method of claim 12, wherein the non-cylindrical outer surface is a tri-lobe configuration that corresponds with the shape of an aortic valve annulus.

27. The method of claim 9, wherein the annulus is the aortic valve annulus, and the pressure that occurs when the annulus is at its greatest diameter occurs at the end of systole.

28. The method of claim 27, wherein the desired pressure is the physiological pressure experience by the annulus at its greatest diameter during the cardiac cycle plus an additional amount of pressure to ensure that the measured dimension of the annulus corresponds to a valve size that will provide a proper interference fit with the annulus.

15. A method of sizing a heart valve annulus for implant of a prosthetic heart valve, comprising:

radially expanding a patient'"'"'s heart valve annulus using a desired pressure on the annulus which is equal to at least the physiological pressure experienced by the annulus at its greatest diameter during the cardiac cycle, wherein the desired pressure is between about 250 mmHg and 500 mmHg;

measuring a dimension of the expanded annulus; and

selecting a prosthetic heart valve based on the measured dimension of the annulus.

16. The method of claim 15, wherein the method further comprises implanting the heart valve in the annulus.

17. The method of claim 16, wherein the act of radially expanding the annulus comprises inserting an orifice-expanding device in the heart valve annulus and expanding the orifice-expanding device to expand the annulus, and the method further comprises determining the pressure exerted by the orifice-expanding device against the annulus in order to expand the annulus to the desired pressure.

18. The method of claim 16, wherein the act of radially expanding the annulus comprises inserting an orifice-expanding device in the heart valve annulus and expanding the orifice-expanding device to expand the annulus, the act of indicating comprises indicating the diameter of the expanded annulus after it is expanded by the orifice expanding device, and the act of implanting the heart valve comprises inserting the heart valve in the annulus and expanding the heart valve to expand the annulus and anchor the heart valve in the expanded annulus, wherein the diameter of the expanded annulus after implanting the heart valve is approximately the same as the diameter of the annulus after it was expanded by the orifice-expanding device.

19. The method of claim 17, wherein the act of implanting the heart valve comprises inserting the heart valve in the annulus and expanding the heart valve to expand the annulus and anchor the heart valve in the expanded annulus, wherein the pressure exerted by the expanded heart valve is approximately the same as the desired pressure.

20. The method of claim 15, wherein the act of radially expanding the annulus comprises inserting an orifice-expanding device in the heart valve annulus and expanding the orifice-expanding device to expand the annulus, and wherein the orifice- expanding device comprises a non-cylindrical outer surface that generally corresponds to the shape of the annulus.

21. The method of claim 20, wherein the non-cylindrical outer surface is a tri-lobe configuration that corresponds with the shape of an aortic valve annulus.

22. The method of claim 15, wherein the annulus is the aortic valve annulus, and the pressure that occurs when the annulus is at its greatest diameter occurs at the end of systole.

23. The method of claim 15, wherein the desired pressure is about 350 mmHg.

24. The method of claim 15, wherein the desired pressure is the physiological pressure experienced by the annulus at its greatest diameter during the cardiac cycle plus an additional amount of pressure to ensure that the measured dimension of the annulus corresponds to a valve size that will provide a proper interference fit with the annulus.

25. The method of claim 15, wherein the desired pressure approximates the pressure the annulus will experience during expansion of an expandable prosthetic valve.