Mitral valve therapy device, system and method
An assembly and method for effecting the condition of a mitral valve annulus of a heart includes a guide wire configured to be fed into the coronary sinus of the heart, and a mitral valve annulus therapy device configured to be slidingly received on the guide wire and advanced into the coronary sinus of the heart on the guide wire. A guide tube may further be employed for guiding the device into the coronary sinus. An introducer which may be employed for pushing the device into or pulling device out of the heart has a mechanism for releasably locking to the device. This enables substitution of the device if needed. Also, the crossover point of the circumflex artery and coronary sinus may be determined and avoided when the device is deployed.
1 .- 15 . (Canceled)
16 . A method of deploying a mitral valve annulus constricting device within the coronary sinus of a heart, the method including the steps of:
A. providing an elongated flexible guide wire having a cross sectional dimension;
B. feeding the guide wire into the coronary sinus of the heart;
C. providing an elongated flexible guide tube having an inner lumen, the inner lumen having a cross sectional dimension greater than the cross sectional dimension of the guide wire;
D. feeding the guide tube into the coronary sinus of the heart over the guide wire with the guide wire within the inner lumen of the guide tube;
E. providing a mitral valve annulus device configured to be slidingly received on the guide wire and within the inner lumen of the guide tube, the device including a proximal end;
F. providing a flexible elongated introducer configured to be slidingly received on the guide wire and within the inner lumen of the guide tube, the introducer having a distal end;
G. placing the device onto the guide wire;
H. placing the introducer onto the guide wire;
I. engaging the distal end of the introducer with the proximal end of the device, the engaging step including releasably locking the proximal end of the device to the distal end of the introducer;
J. pushing the device with the introducer in a distal direction along the guide wire and within the guide tube until the device is at least partially encircling the mitral valve within the coronary sinus of the heart; and
K. withdrawing the introducer and the guide tube from the heart:
17 . (Canceled)
18 . The method of claim 16 including the further step J( 1 ) of releasing the proximal end of the device from the distal end of the introducer prior to withdrawing the introducer.
19 . The method of claim 18 including the further step L of testing the effectiveness of the device after the withdrawing step.
20 . The method of claim 19 including the further steps of replacing the device with a further device, the replacing steps including: feeding the guide tube into the coronary sinus of the heart over the guide wire and the device; feeding the introducer over the guide wire and into the guide tube; releasably locking the distal end of the introducer to the proximal end of the device in a proximal direction and from the guide tube; and repeating steps E and G through L with a further device.
21 .- 30 . (Canceled)
31 . A method of deploying a mitral valve annulus reshaping device within the coronary sinus of a heart, the method including the steps of:
inserting a guide wire into the coronary sinus of the heart;
deforming the mitral valve annulus reshaping device from an unstressed shape having a radius smaller than the radius of a mitral valve annulus of the heart to a deformed shape; and
advancing the mitral valve annulus reshaping device on the guide wire and into the coronary sinus into a position such that the device at least partially encircles the mitral valve of the heart.
32 . The method of claim 31 wherein the advancing step further includes the steps of slidingly mounting an elongated flexible introducer onto the guide wire proximal to the device, engaging the distal end of the introducer with the proximal end of the device, and pushing the device distally into the coronary sinus with the introducer.
33 . The method of claim 32 including the further step of withdrawing the introducer after deploying the device.
34 . The method of claim 33 wherein the engaging step includes releasably locking the proximal end of the device to the distal end of the introducer.
35 . The method of claim 34 including the further step of releasing the proximal end of the device from the distal end of the introducer prior to withdrawing the introducer.
36 . The method of claim 32 including the further steps of: providing an elongated flexible guide tube having an inner lumen, the inner lumen having a cross sectional dimension greater than the cross sectional dimension of the guide wire; feeding the guide tube into the coronary sinus of the heart over the guide wire with the guide wire within the inner lumen of the guide tube; and wherein the pushing step includes pushing the device along the guide wire and within the guide tube.
37 . The method of claim 36 wherein the engaging step includes releasably locking the proximal end of the device to the distal end of the introducer.
38 . The method of claim 37 including the further steps of releasing the proximal end of the device from the distal end of the introducer and withdrawing the introducer and the guide tube after deploying the device.
39 .- 57 . (Canceled)