Mitral valve therapy assembly and method

• US 20040153052A1
• Filed: 09/10/2003
• Published: 08/05/2004
• Est. Priority Date: 05/14/2001
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mathis, Mark L.
• Granted Patent: US 6,966,926 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: Y10S 623/904 Heart

Abstract

An assembly for effecting the condition of a mitral valve of a heart includes a mitral valve therapy device, a guide wire, and a guide tube. The mitral valve therapy device is configured to reshape the mitral valve annulus of the heart when placed within the coronary sinus adjacent the mitral valve annulus. The guide wire is configured to be fed into the coronary sinus of the heart adjacent the mitral valve annulus. The guide tube has a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The guide tube further includes a side port, intermediate the distal and proximal ends which communicates with the lumen. This permits the guide tube to be slidingly received on the guide wire with the guide wire extending from the distal end, through the lumen, and out the side port. In use, the guide tube is slid along the guide wire into the coronary sinus. The mitral valve therapy device is then delivered by the guide tube into the coronary sinus adjacent the mitral valve annulus.

Claims

1. An assembly for effecting the condition of a mitral valve annulus of a heart comprising:

a mitral valve therapy device configured to reshape the mitral valve annulus of the heart when placed within the coronary sinus adjacent the mitral valve annulus;

a guide wire configured to be fed into the coronary sinus of the heart adjacent the mitral valve annulus; and

a guide tube having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the guide tube further including a side port, intermediate the distal end and the proximal end and communicating with the lumen, to permit the guide tube to be slidingly received on the guide wire with the guide wire extending from the distal end, through the lumen, and out the side port,

whereby the guide tube is slidable along the guide wire to a position adjacent the mitral valve annulus within the coronary sinus and the mitral valve therapy device is guidable within the guide tube for placement in the coronary sinus adjacent the mitral valve annulus.

2. The assembly of claim 1 further including an introducer dimensioned to be received within the guide tube lumen for pushing the mitral valve therapy device towards the distal end of the guide tube.

3. The assembly of claim 2 wherein the introducer includes a lumen for being slidably received on the guide wire within the guide tube lumen.

4. The assembly of claim 1 wherein the mitral valve annulus therapy device is further configured to be slidably received on the guide wire.

5. The assembly of claim 4 further including an introducer dimensioned to be received within the guide tube lumen for pushing the mitral valve therapy device towards the distal end of the guide tube.

6. The assembly of claim 2 wherein the introducer includes a lumen for being slidably received on the guide wire within the guide tube lumen.

7. The assembly of claim 6 wherein the introducer has a distal end and a slot extending proximally from the introducer distal end and communicating with the introducer lumen.

8. The assembly of claim 1 wherein the guide tube further includes a delivery slot communicating with the lumen and proximal to the side port to release the mitral valve therapy device from the guide tube.

9. The assembly of claim 8 further including an introducer dimensioned to be received within the guide tube lumen for pushing the mitral valve therapy device towards and out of the delivery slot.

10. The assembly of claim 1 wherein the guide wire is an elongated coil.

11. The assembly of claim 1 wherein the guide wire is formed of a material visible under X ray fluoroscopy.

12. The assembly of claim 1 wherein at least a portion of the device is visible under X ray fluoroscopy.

13. The assembly of claim 1 wherein the device is visible under X ray fluoroscopy.

14. The assembly of claim 1 further including an elongated introducer configured to engage the device proximal to the device to advance the device into the coronary sinus.

15. The assembly of claim 14 wherein the introducer is an elongated coil.

16. A method of deploying a mitral valve therapy device within the coronary sinus of a heart adjacent the mitral valve annulus, the method including the steps of:

A. providing an elongated flexible guide wire having a cross sectional dimension;

B. feeding guide wire into the coronary sinus of the heart;

C. providing an elongated flexible guide tube having a proximal end, a distal end, a lumen, and a side port communicating with the lumen;

D. feeding the guide tube into the coronary sinus of the heart with the guide wire extending through the lumen from the distal end to and through the side port;

E. providing a mitral valve therapy device configured to be slidingly received within the lumen of the guide tube, the device including a proximal end;

F. providing a flexible elongated introducer configured to be slidingly received within the lumen of the guide tube, the introducer having a distal end;

G. placing the device into the guide tube lumen;

H. placing the introducer into the guide tube lumen;

I. engaging the distal end of the introducer with the proximal end of the device;

J. pushing the device with the introducer in a distal direction within the guide tube lumen until the device is at least partially encircling the mitral valve within the coronary sinus of the heart; and

K. releasing the device from the guide tube into the coronary sinus of the heart adjacent to the mitral valve annulus.

17. The method of claim 16 wherein the step of placing the device into the guide tube lumen includes the step of placing the device on the guide wire.

18. The method of claim 16 wherein the step of placing the introducer into the guide tube lumen includes the step of placing the introducer on the guide wire.

19. The method of claim 16 including the further step of providing a delivery slot in the guide tube proximal to the side port and communicating with the lumen, and wherein the releasing step includes the step of advancing the device from the lumen through the delivery slot and into the coronary sinus.

20. The method of claim 16 wherein the releasing step includes the step of releasing the device from the distal end of the guide tube.

21. The method of claim 16 wherein the step of placing the device into the guide tube lumen includes placing the device on the guide wire and wherein the step of releasing the device includes releasing the device from the distal end of the guide tube.

22. The method of claim 21 including the further step of testing the effectiveness of the device while the device is on the guide wire.

23. The method of claim 16 including the further step of withdrawing the introducer, the guide tube, and the guide wire from the coronary sinus.

24. The method of claim 16 wherein the guide wire is visible under X ray fluoroscopy and wherein the method includes the further steps of:

inserting a second wire into the circumflex artery of the heart, the second wire being visible under X ray fluoroscopy;

subjecting the heart to X ray fluoroscopic examination to visualize the crossover point of the guide wire and the second wire; and

releasing the mitral valve annulus therapy device within the coronary sinus in a position such that the device is proximal to the crossover point of the guide wire and the second wire.