SIZING DEVICE AND METHOD OF POSITIONING A PROSTHETIC HEART VALVE

• US 20140107768A1
• Filed: 03/07/2013
• Published: 04/17/2014
• Est. Priority Date: 10/12/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Venkatasubramanian, Ramji T.
• Granted Patent: US 9,801,721 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped

Abstract

A sizing device for a collapsible prosthetic heart valve includes a collapsible and expandable stent. A microelectromechanical sensor is coupled to the stent, the sensor being capable of collecting information related to the size and stiffness of tissue.

Claims

1. A sizing device for use in implanting a collapsible prosthetic heart valve in a native valve annulus, the sizing device comprising:

a collapsible and expandable stent having an annulus section and an aortic section; and

a sensor coupled to the annulus section of the stent, the sensor being capable of collecting information related to the native valve annulus.

2. The device of claim 1, wherein the stent is self-expandable.

3. The device of claim 2, wherein the stent comprises nitinol.

4. The device of claim 2, wherein the sensor is flexible.

5. The device of claim 1, wherein the information includes the diameter of the native valve annulus.

6. The device of claim 1, wherein the information includes data relating to the extent of calcification of tissue of the native valve annulus.

7. The device of claim 1, wherein the sensor includes at least one capacitor having variable capacitance, the capacitance corresponding to the information.

8. The device of claim 1, wherein the sensor includes at least one piezoelectric material.

9. The device of claim 1, wherein the sensor comprises a polymer.

10. The device of claim 9, wherein the polymer comprises polydimethylsiloxane.

11. The device of claim 1, wherein the sensor is a microelectromechanical sensor.

12. The device of claim 1, wherein the sensor comprises at least two electrodes mounted on a fabric.

13. The device of claim 1, further comprising a deployment device configured to expand the collapsible and expandable stent via a series of rotations.

14. A method for determining the proper fitment of a prosthetic heart valve within a native valve annulus, comprising:

introducing a sizing device into the native valve annulus, the sizing device including (i) a collapsible and expandable stent having an annulus section and an aortic section and (ii) a sensor coupled to the annulus section of the stent, the sensor being capable of collecting information related to the native valve annulus;

expanding the diameter of the stent within the native valve annulus; and

acquiring information related to the native valve annulus via the sensor.

15. The method of claim 14, wherein the information includes the diameter of the native valve annulus.

16. The method of claim 14, wherein the information includes data relating to an extent of calcification of tissue of the native valve annulus.

17. The method of claim 14, wherein the step of expanding the diameter of the stent includes rotating a first portion of a deployment device relative to a second portion of the deployment device within the native valve annulus.

18. The method of claim 14, wherein the stent is self-expandable, the sizing device further includes a removable cannula disposed about the stent to maintain the stent in a collapsed configuration, and the step of expanding the diameter of the stent includes removing the cannula from around the stent.

19. The method of claim 17, further comprising expanding the diameter of the stent in-vitro to establish a relationship between the number of rotations of the first portion of the deployment device relative to the second portion of the deployment device and a diameter of the stent.

20. The method of claim 19, wherein the step of acquiring information related to the native valve annulus includes comparing the number of rotations within the native valve annulus to the relationship.

21. The method of claim 17, wherein the expanding step comprises expanding the diameter of the stent within the native valve annulus until the sensor measures a radial force of a predetermined value.