Apparatus and Method for Measuring Body Orifice

• US 20110098602A1
• Filed: 10/27/2009
• Published: 04/28/2011
• Est. Priority Date: 10/27/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Campbell, Louis A., Oba, Travis Z.
• Granted Patent: US 8,449,625 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• 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. An apparatus for measuring an expanded internal orifice of a patient, the apparatus comprising:

an orifice-expanding device located at or near a distal end of the apparatus, the orifice-expanding device being radially expandable from a first configuration to a second, expanded configuration to cause corresponding radial expansion of the orifice;

a pressure-measuring device configured to measure a pressure applied to the orifice by the orifice-expanding device; and

a size-measuring device that allows a user to measure a dimension of the orifice after it has been expanded by the orifice-expanding device, wherein the measurement of the dimension is obtained independently of the pressure measurement measured by the pressure measuring device.

2. The apparatus according to claim 1, wherein the size-measuring device comprises a coiled member, the coiled member surrounding at least a portion of the orifice-expanding device and being configured to uncoil when the orifice-expanding device expands from the first configuration to the second configuration.

3. The apparatus according to claim 2, wherein the coiled member has an outer face, the outer face having visual indicia that correspond to different dimensions for measuring the size of the expanded orifice.

4. The apparatus according to claim 3, wherein the coiled member has a first end and a second end, the first end being attached to a portion of the orifice-expanding device, and

wherein the position of the second end of the coiled member relative to the outer face of the coiled member identifies the dimension of the expanded orifice.

5. The apparatus according to claim 1, further comprising a shaft member connected to the orifice-expanding device,

wherein the size-measuring device comprises a wire member, the wire member surrounding at least a portion of the orifice-expanding device, and

wherein the wire member has a first end and a second end, the first end being fixed in position relative to the orifice-expanding device and the second end having a marker that is free to move longitudinally along the shaft, wherein the position of the marker along the shaft identifies the dimension of the expanded orifice.

6. The apparatus according to claim 5, wherein the wire member passes through openings in one or more bar members that are attached to the orifice-expanding device.

7. The apparatus according to claim 1, wherein the size-measuring device comprises a locking member, the locking member surrounding at least a portion of the orifice-expanding device, the locking member being configured to increase in diameter from a first position to a plurality of second positions, and

wherein when the locking member is expanded to one of the plurality of second positions, the locking member locks in that position, thereby preventing the locking member from returning to the first position.

8. The apparatus according to claim 7, wherein the locking member is a one-way locking member that permits an increase in radial size of the size measuring member but prevents a decrease in radial size of the size measuring member.

9. The apparatus according to claim 1, wherein the orifice-expanding device is an inflatable balloon.

10. The apparatus of claim 9, wherein the pressure-measuring device measures the pressure exerted by the balloon based on the volume of fluid added to the balloon.

11. The apparatus according to claim 1, wherein the orifice-expanding device has one or more linkages that effect radial expansion of the orifice-expanding device, and the pressure-measuring device comprises one or more strain gauges positioned on the orifice-expanding device.

12. A method comprising:

accessing an internal orifice of a patient'"'"'s body;

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

expanding the orifice-expanding device to cause it to exert a desired pressure against the orifice to cause the orifice to expand; and

measuring a dimension of the expanded orifice independently of the pressure exerted by the orifice-expanding device.

13. The method of claim 12, wherein the orifice comprises an annulus of a heart valve and the method further comprises selecting a prosthetic heart valve based on the measured dimension of the annulus, and implanting the heart valve in the annulus.

14. The method of claim 12, wherein the act of measuring a dimension of the expanded orifice is accomplished while the orifice-expanding device is in the expanded orifice.

15. The method of claim 14, wherein the act of measuring a dimension of the expanded orifice comprises reading visual indicia on the sizing apparatus and recording the measured dimension.

16. The method of claim 14, 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 orifice comprises observing the position of the second end of the coiled member relative to the visual indicia.

17. The method of claim 14, 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 orifice comprises observing the position of the movable indicator relative to a location on the shaft.

18. The method of claim 12, wherein the act of measuring a dimension of the expanded orifice is accomplished after the orifice-expanding device is removed from the body.

19. The method of claim 18, 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 orifice.

20. The method of claim 12, further comprising measuring the pressure exerted by the orifice-expanding device.

21. The method according to claim 12, wherein the orifice-expanding device is a balloon and the act of expanding comprises inflating the balloon to expand the orifice.

22. The method according to claim 12, 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 orifice by the orifice-expanding device from the measured strain.

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

24. A method comprising:

radially expanding an orifice in a patient'"'"'s body; and

indicating a dimension of the expanded orifice, wherein the act of indicating the dimension of the expanded orifice does not include calculating the dimension based on the pressure exerted by the orifice-expanding device against the orifice.

25. The method of claim 24, wherein the orifice comprises an annulus of a heart valve and the method further comprises selecting a prosthetic heart valve based on the dimension of the annulus, and implanting the heart valve in the annulus.

26. The method of claim 25, wherein the act of radially expanding the orifice 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 measuring the pressure exerted by the orifice-expanding device against the annulus in order to expand the annulus to a desired pressure.

27. The method of claim 25, wherein the act of radially expanding the orifice 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.

28. The method of claim 26, 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.

29. An apparatus for measuring a heart valve annulus of a patient, comprising:

expansion means for expanding the heart valve annulus; and

measuring means for measuring the diameter of the expanded annulus.

30. The apparatus of claim 29, further comprising means for measuring the pressure exerted by the expansion means against the annulus to allow expansion of the annulus to a desired pressure.