Devices, systems, and methods for reshaping a heart valve annulus, including the use of a bridge implant having an adjustable bridge stop
Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial adjustability and retrievability years after implant. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize an adjustable bridge stop to secure the implant, and the methods of implantation employ various tools.
1 . A bridge stop apparatus comprising
a bridge stop housing having a length and a width,
an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow a bridging element to extend through at least a portion of the length of the aperture, and
an adjustment mechanism coupled to the bridge stop housing to allow adjustment of a length of the bridging element.
2 . A bridge stop according to claim 1
wherein the adjustment mechanism includes a catheter releasably coupled to the bridge stop to activate the adjustment mechanism.
3 . A bridge stop according to claim 1
wherein the adjustment mechanism is located within the aperture within the bridge stop housing.
4 . A bridge stop according to claim 1
wherein the adjustment mechanism comprises a locking collar.
5 . A bridge stop according to claim 1
wherein the adjustment mechanism allows for only lengthening or only shortening of the bridging element.
6 . A bridge stop according to claim 1
wherein the adjustment mechanism allows for both lengthening and shortening of the bridging element.
7 . A bridge stop according to claim 1
wherein the adjustment mechanism is sized and configured to allow for repeatable adjustment.
8 . A bridge stop according to claim 1
wherein the bridge stop adjustment mechanism includes a static state, and
the bridge stop adjustment mechanism restrains the bridging element in the adjustment mechanism's static state, thereby requiring a positive activation force necessary to allow the bridging element to be adjusted.
9 . A bridge stop according to claim 1
wherein the bridging element includes discrete stop beads to allow the bridging element to be adjusted in discrete lengths.
10 . A bridge stop according to claim 1
wherein the bridging element includes a toothed ribbon portion or a perforated ribbon portion or a threaded shaft portion extending through at least a portion of the aperture in the bridge stop housing.
11 . A bridge stop according to claim 1
wherein the length of the bridge stop housing is greater than the width of the bridge stop housing.
12 . A bridge stop according to claim 1
wherein the bridge stop housing further includes at least one radio-opaque marker.
13 . A bridge stop according to claim 1
wherein the bridge stop includes a relocation element.
14 . A bridge stop according to claim 13
the relocation element further including at least one radio-opaque marker.
15 . A bridge stop apparatus comprising
a bridge stop housing, the housing comprising an inner portion and an outer portion, the housing having a length and a width,
an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow a bridging element to extend through at least a portion of the length of the aperture, and
an adjustment mechanism coupled to the bridge stop housing to allow adjustment of the bridging element.
16 . A bridge stop according to claim 15
wherein the adjustment mechanism comprises rotation of either the inner portion or the outer portion.
17 . A bridge stop according to claim 15
wherein the inner portion is positioned completely within the outer portion.
18 . A bridge stop according to claim 15
wherein the inner portion extends partially outside the outer portion.
19 . An implant system comprising
a bridging element sized and configured to span a left atrium between a great cardiac vein and an interatrial septum,
a first bridge stop coupled to the bridging element,
a second bridge stop coupled to the bridging element, the second bridge stop comprising,
a bridge stop housing having a length and a width,
an aperture extending through the length of the bridge stop housing, the aperture sized and configured to allow a bridging element to extend through at least a portion of the length of the aperture, and
an adjustment mechanism coupled to the bridge stop housing to allow adjustment of the bridging element.
20 . An implant system according to claim 19
wherein the bridge stop housing further comprises an inner portion and an outer portion.
21 . An implant system according to claim 20
wherein the adjustment mechanism comprises rotation of either the inner portion or the outer portion to allow the bridging element to be lengthened or shortened.
22 . A method of adjusting a bride stop as defined in claim 1 .
23 . A method of adjusting a length of a bridging element comprising
providing a bridge stop having an adjustment mechanism as defined in claim 1 , and
operating the adjustment mechanism to lengthen or to shorten the bridging element.
24 . A method according to claim 23 further including
repeating the operating the adjustment mechanism to lengthen or shorten the bridging element until a desired length of the bridging element is achieved.
25 . A method according to claim 24 further including
allowing the bridging element to settle for a predetermined time before repeating the operating the adjustment mechanism step.
26 . A method according to claim 23 further including
coupling a catheter to the bridge stop, the catheter being used to operate the adjustment mechanism.
27 . A method according to claim 23 further including
coupling a catheter to the bridging element, the catheter being used to lengthen or shorten the bridging element.
28 . A method according to claim 23 further including
providing a catheter, the catheter including a proximal end and a distal end, the catheter having a first adjustment mechanism on its proximal end and a second adjustment mechanism on its proximal end,
coupling the first adjustment mechanism to the bridge stop,
coupling the second adjustment mechanism to the bridging element,
operating the first adjustment mechanism to allow adjustment of the bridging element,
operating the second adjustment mechanism to lengthen or shorten the bridging element, and
operating the first adjustment mechanism again to re-secure the bridging element.