Diagnostic kit to assist with heart valve annulus adjustment

• US 7,211,110 B2
• Filed: 12/09/2004
• Issued: 05/01/2007
• Est. Priority Date: 12/09/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Solem, Jan Otto, Rowe, Stanton J., Bourang, Henry, Fariabi, Sepehr
• Primary Examiner(s): Pezzuto; Robert
• Assistant Examiner(s): Lee; Yun Haeng
• Application Number:
  US11/008,055
• Publication Number:
  US 20060129051A1
• Time in Patent Office: 873 Days
• Field of Search: 600/508, 623/2.36, 623/2.37
• US Class Current: 623/2.37
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape

Abstract

A diagnostic device for determining the amount of change required in a coronary sinus to reduce valve regurgitation. The device includes a distal tube having a distal anchor at a distal end portion of the distal tube, a proximal tube having a proximal anchor at a distal end portion of the proximal tube, and an adjustor to move the distal tube relative to the proximal tube. The proximal tube and the distal tube together form a telescoping elongate body adapted to fit within the coronary sinus, and the device includes a scale to measure the movement of the distal anchor relative to the proximal anchor.

Claims

1. A method for determining an amount of adjustment to a coronary sinus necessary to reduce heart valve regurgitation comprising:

inserting a diagnostic device into a coronary sinus, the diagnostic device including a distal anchor and a proximal anchor and an elongate member extending between the distal and proximal anchors,

anchoring the distal anchor to the coronary sinus,

anchoring the proximal anchor to the coronary sinus,

adjusting a length of the elongate member between the distal and proximal anchors to reduce heart valve regurgitation,

measuring the amount of adjustment required to achieve a desired reduction of heart valve regurgitation,

disengaging the distal and proximal anchors from the coronary sinus, and

removing the diagnostic device from the coronary sinus.

2. The method of claim 1, wherein anchoring the proximal and distal anchors comprises expanding the anchors from a compressed state to an expanded state.

3. The method of claim 2, wherein expanding the distal anchor and the proximal anchor comprises expanding by a fluid.

4. The method of claim 1, wherein inserting the diagnostic device comprises inserting the diagnostic device into a great cardiac vein portion of the coronary sinus.

5. The method of claim 1, wherein adjusting the length of the elongate member straightens the curvature of the coronary sinus.

6. The method of claim 1 wherein adjusting the length of the elongate member cinches the coronary sinus.

7. The method of claim 1 further comprising selecting a therapy device and securing the therapy device to the coronary sinus.

8. A method of determining the amount of adjustment to a coronary sinus necessary for reducing mitral valve regurgitation, comprising:

providing an elongate diagnostic device having a proximal tube with a proximal anchor mounted thereon and a distal tube with a distal anchor mounted thereon;

advancing the diagnostic device at least partially into a coronary sinus of a heart;

expanding the distal anchor;

expanding the proximal anchor;

moving the distal tube proximally relative to the proximal tube to alter a curvature of the coronary sinus and thereby cause the coronary sinus to press against the mitral valve annulus;

measuring a degree of mitral valve regurgitation;

measuring an amount of movement of the distal tube necessary to achieve a desired reduction in mitral valve regurgitation; and

removing the diagnostic device from the coronary sinus.

9. The method of claim 8, further comprising selecting an implantable valve repair device configured for deployment in the coronary sinus based on the measured movement of the distal tube.

10. The method of claim 8, wherein the amount of movement of the distal tube is measured using markers disposed on the diagnostic device.

11. The method of claim 8, wherein the degree of mitral valve regurgitation is measured using ultrasound.

12. A method of treating mitral valve regurgitation, comprising:

advancing an elongate diagnostic device through a patient'"'"'s vasculature and at least partially into a coronary sinus;

adjusting a length of the diagnostic device for applying a force to the mitral valve annulus;

measuring a change in mitral valve regurgitation after adjusting the length of the diagnostic device to determine whether the patient can be treated using an implantable mitral valve repair d vice;

measuring a chain e in length of the diagnostic device; and

removing the diagnostic device from the patient'"'"'s vasculature.