Device for measuring an aortic valve annulus in an expanded condition

• US 10,231,646 B2
• Filed: 03/17/2017
• Issued: 03/19/2019
• 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 Zenyo, Pintor, Rafael
• Primary Examiner(s): Towa, Rene T
• Application Number:
  US15/462,386
• Publication Number:
  US 20170188889A1
• Time in Patent Office: 732 Days
• 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 aortic valve annulus of a patient, the apparatus comprising:

a proximal handle having a shaft extending distally therefrom;

an orifice-expanding device located at or near a distal end of the shaft, the orifice-expanding device having three arms connected rigidly and extending from the distal end of the shaft in a distal direction, each of the three arms being connected rigidly to one of three circumferentially-spaced expanding portions with outer surfaces that are shaped to conform to the tri-lobe shape of the aortic valve annulus, the expanding portions being radially expandable from a first configuration to a second, expanded configuration to cause corresponding radial expansion of an aortic valve annulus, the expanding portions being interlocked by locking mechanisms that permit the expanding portions to move away from one another, while at the same time the locking mechanisms prevent the expanding portions from collapsing back towards each other, wherein the locking mechanisms include grooves or teeth that mate with opposing grooves or teeth on the inside of the expanding portions;

a pressure-measuring device configured to measure a pressure applied to the aortic valve annulus by the expanding portions; and

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

2. The apparatus of claim 1, wherein the pressure-measuring device comprises one or more strain gauges positioned on one or more arms.

3. The apparatus of claim 1, wherein the orifice-expanding device includes an inflatable balloon positioned within the expanding portions and configured to force the expanding portions outward and thus circumferentially away from each other.

4. The apparatus of claim 3, wherein the pressure-measuring device includes a pressure monitoring gauge that measures the pressure exerted by the balloon on the expanding portions.

5. The apparatus of claim 1, wherein the orifice-expanding device has one or more mechanical linkages within the expanding portions that effect radial expansion of the three expanding portions.

6. The apparatus of claim 1, wherein expansion of the expanding portions causes distal ends of the arms to flex outward.

7. The apparatus of claim 1, further including a visual alpha numeric display located on the handle that displays the pressure applied to the aortic valve annulus.

8. The apparatus of claim 1, wherein the size-measuring device comprises a secondary hole gauge having various size openings configured to receive the expanding portions such that the size of the expanding portions may be determined by placing the expanding portions them in the various openings until the proper size of the expanding portions is matched.

9. An apparatus for measuring an expanded aortic valve annulus of a patient, the apparatus comprising:

a proximal handle having a shaft extending distally therefrom;

an orifice-expanding device located at or near a distal end of the shaft, the orifice-expanding device having three arms connected rigidly and extending from the distal end of the shaft in a distal direction, each of the three arms being connected rigidly to one of three circumferentially-spaced expanding portions with outer surfaces that are shaped to conform to the tri-lobe shape of the aortic valve annulus, and a balloon extending from the shaft and positioned within the expanding portions to radially expand the expanding portions from a first configuration to a second, expanded configuration and cause corresponding radial expansion of an aortic valve annulus, wherein expansion of the expanding portions causes distal ends of the arms to flex outward, the expanding portions being interlocked by locking mechanisms that permit the expanding portions to move away from one another, while at the same time the locking mechanisms prevent the expanding portions from collapsing back towards each other;

a pressure-measuring device that measures the pressure exerted by the balloon on the expanding portions and thus the pressure applied to the aortic valve annulus by the expanding portions; and

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

10. The apparatus of claim 9, wherein the pressure-measuring device includes a pressure monitoring gauge that measures the pressure exerted by the balloon on the expanding portions.

11. The apparatus of claim 10, further including one or more strain gauges positioned on one or more arms to provide a secondary measure of the pressure exerted by the balloon on the expanding portions.

12. The apparatus of claim 9, further including a visual alpha numeric display located on the handle that displays the pressure applied to the aortic valve annulus.

13. The apparatus of claim 9, wherein the size-measuring device comprises a secondary hole gauge having various size openings configured to receive the expanding portions such that the size of the expanding portions may be determined by placing the expanding portions in the various openings until the proper size of the expanding portions is matched.

14. The apparatus of claim 9, wherein the locking mechanisms include grooves or teeth that mate with opposing grooves or teeth on the inside of the expanding portions.

15. An apparatus for measuring an expanded aortic valve annulus of a patient, the apparatus comprising:

a proximal handle having a shaft extending distally therefrom;

an orifice-expanding device located at or near a distal end of the shaft, the orifice-expanding device having three circumferentially-spaced expanding portions with outer surfaces that are shaped to conform to the tri-lobe shape of the aortic valve annulus, and a balloon extending from the shaft and positioned within the expanding portions to radially expand the expanding portions from a first configuration to a second, expanded configuration and cause corresponding radial expansion of an aortic valve annulus, the expanding portions being interlocked by locking mechanisms that permit the expanding portions to move away from one another, while at the same time the locking mechanisms prevent the expanding portions from collapsing back towards each other, wherein the locking mechanisms include grooves or teeth that mate with opposing grooves or teeth on the inside of the expanding portions;

a pressure-measuring device that measures the pressure exerted by the balloon on the expanding portions and thus the pressure applied to the aortic valve annulus by the expanding portions; and

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

16. The apparatus of claim 15, wherein the pressure-measuring device includes a pressure monitoring gauge that measures the pressure exerted by the balloon on the expanding portions.

17. The apparatus of claim 16, wherein the orifice-expanding device further includes three arms connected rigidly and extending from the shaft in a distal direction and each connected rigidly to one of the expanding members, wherein expansion of the expanding members causes distal ends of the arms to flex outward.

18. The apparatus of claim 17, further including one or more strain gauges positioned on one or more arms to provide a secondary measure of the pressure exerted by the balloon on the expanding portions.