Universal Valve Annulus Sizing Device

• US 20100249661A1
• Filed: 03/18/2010
• Published: 09/30/2010
• Est. Priority Date: 03/19/2009
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio SPA
• Inventors: Carlino, Felice G., Righini, Giovanni, Rolando, Giovanni
• Granted Patent: US 8,715,207 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6871 Stomach
• 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 internal dimension of a native cardiac valve annulus includes an elongated support member having a proximal portion and a distal portion. A measuring portion is coupled to the distal portion, and an indicator is coupled to the proximal portion of the support member. The measuring portion is biased towards a deployed configuration such that when deployed it applies an outwardly directed radial force to the native valve annulus.

Claims

1. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising:

an elongated support member having a proximal portion and a distal portion, the distal portion including an end having a bore and a longitudinal slot;

a measuring band having a first end and a second end, the first end disposed within the bore and the second end coupled to the distal portion;

a shaft extending through the support member, the shaft having a distal end coupled to the first end of the measuring band and a proximal end; and

an indicator coupled to the proximal end of the shaft, the indicator adapted to provide an indication of the internal dimension;

wherein the measuring band has a contracted configuration in which the band is at least partially wound about a transverse axis and an expanded configuration in which the band is substantially unwound.

2. The device of claim 1 wherein the measuring band is self-expanding and is adapted to apply an outwardly directed radial force against the valve annulus.

3. The device of claim 2 wherein the measuring band is removable from the distal portion of the support member.

4. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising an elongated support member having a proximal portion and a distal portion, a measuring band coupled to the distal portion, and an indicator coupled to the proximal portion, wherein the measuring band is biased towards a deployed configuration such that when deployed it applies an outwardly directed radial force to the native valve annulus.

5. The device of claim 4 wherein the measuring band is removable from the distal portion of the support member.

6. The device of claim 5 wherein the measuring band is made from a nickel-titanium alloy.

7. The device of claim 4 wherein the measuring band is self-expanding and is adapted to apply an outwardly directed radial force against the valve annulus.

8. The device of claim 4 wherein the edges of the measuring band are softened so as to minimize damage to any adjacent anatomical tissue.

9. The device of claim 4 further comprising a torque applicator coupled to the proximal portion of the elongated support member, wherein the torque applicator is capable of transmitting a torque provided by the user to a first end of the measuring band.

10. The device of claim 9 wherein the torque applicator includes a torque limiter capable of restricting the amount of torque transmitted by the user to the first end of the measuring band to a desired torque level.

11. The device of claim 4 wherein the elongated support member is lockably flexible.

12. The device of claim 4 wherein the measuring band includes a longitudinally extending portion which is at least partially radiopaque, to facilitate visualization of the measuring band during sizing.

13. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising a body portion and a measuring portion, the measuring portion including an expandable element configured to substantially adapt to the shape of the annulus.

14. The device of claim 13 wherein the expandable element is removable from the distal portion of the support member.

15. The device of claim 13 wherein the expandable element is made from a superelastic material.

16. The device of claim 13 wherein the expandable element is a measuring band.

17. The device of claim 13 the expandable element are selected such that the expandable element generates an outwardly directed radial force against the valve annulus.

18. The device of claim 16 wherein the dimensions of the expandable element are selected such that the outwardly directed radial force has a magnitude about equal to a self-expanding prosthetic valve to be implanted.

19. The device of claim 13 wherein the expandable element is a plurality of petals.