Heart valve leaflet locator

• US 7,004,176 B2
• Filed: 10/17/2003
• Issued: 02/28/2006
• Est. Priority Date: 10/17/2003
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Lau, Jan
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US10/688,712
• Publication Number:
  US 20050085903A1
• Time in Patent Office: 865 Days
• Field of Search: 128/898, 623/2.12, 623/904, 606/113, 606/114, 606/127, 600 13- 16
• US Class Current: 128/898
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2472 Devices for testing

Abstract

Disclosed are methods and devices for determining valve leaflet orientation. A catheter is provided with a conformable, radiopaque target. The target is deployed within a valve, such as the mitral valve. The conformable target conforms to the coaptation axis in response to closing of the valve leaflets. That coaptation axis may then be visualized, and utilized to determine information about valve operation, or to assist in placement of devices in the vicinity of the valve.

Claims

1. A method of assessing the functionality of a heart valve, comprising the steps of:

positioning a device within the valve, the device being conformable for conforming to the coaption axis of the valve and moveable in response to opening and closing of the valve; and

observing the device when the valve is closed, to determine the spatial orientation of the coaptation axis for evaluating valve function.

2. A method of assessing the functionality of a heart valve as in claim 1, wherein the positioning step comprises transluminally positioning.

3. A method of assessing the functionality of a heart valve as in claim 2, comprising the steps of transluminally advancing the device through the aortic valve and into the mitral valve.

4. A method of assessing the functionality of a heart valve as in claim 2, comprising the steps of transluminally advancing the device into the right atrium and across the atrial septum into the mitral valve.

5. A method of assessing the functionality of a heart valve as in claim 1, wherein the positioning step comprises positioning a plurality of radiopaque markers within the valve.

11. A method of assessing the functionality of a heart valve as in claim 1, comprising positioning an implant within the coronary sinus in a preselected relationship to the device.

12. A method of assessing the functionality of a heart valve as in claim 11, wherein the implant is positioned such that it applies pressure on a posterior leaflet of the mitral valve.

6. A method of determining leaflet orientation of a mitral valve, comprising the steps of:

advancing the distal end of a catheter through the left ventricle to a position adjacent the mitral valve;

deploying a radiopaque target from the distal end of the catheter to a location within the mitral valve, the radiopaque target being sufficiently conformable to reconfigure in response to opening and closing of the mitral valve; and

observing the alignment of the radiopaque target in response to closing of the mitral valve.

7. A method as in claim 6, wherein the radiopaque target comprises a plurality of radiopaque markers.

8. A method as in claim 7, further comprising a plurality of wires and wherein the plurality of radiopaque markers are disposed on the plurality of wires.

9. A method as in claim 7, further comprising an expandable basket and wherein the plurality of radiopaque markers are disposed on the expandable basket.

10. A method of assessing the functionality of a valve, comprising the steps of:

providing a conformable target, the conformable target having a primary axis and configured to conform to the coaption axis of the valve during opening and closing of the valve;

positioning the conformable target within the valve;

visualizing the target along a viewing axis which is transverse to the primary axis, in the vicinity of the valve; and

observing the orientation of the target when the valve is open and closed for assessing the functionality of the valve.