Methods and devices for tissue grasping and assessment
Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.
1. A fixation device, comprising:
a first distal element and a second distal element;
a first proximal element moveable relative to the first distal element between a first position of the first proximal element and a second position of the first proximal element to grasp a first leaflet of a heart valve in a first target area defined by the first proximal element and the first distal element;
a second proximal element moveable relative to the second distal element between a first position of the second proximal element and a second position of the second proximal element to grasp a second leaflet of the heart valve in a second target area defined by the second proximal element and the second distal element;
a first indicator coupled with the first distal element to indicate a presence of the first leaflet in the first target area, wherein the first indicator extends into the first target area and is configured to pass through the first distal element by the presence of the first leaflet grasped within the first target area; and
a second indicator coupled with the second distal element to indicate a presence of the second leaflet in the second target area, wherein the second indicator extends into the second target area and is configured to pass through the second distal element by the presence of the second leaflet grasped within the second target area.
2. The fixation device of claim 1 , wherein the first indicator is configured to change its orientation by the presence of the first leaflet grasped within the first target area; and
wherein the second indicator is configured to change its orientation by the presence of the first leaflet grasped within the first target area.
3. The fixation device of claim 1 , wherein the first indicator comprises an enhanced visibility material viewable using a visualization technique; and
wherein the second indicator comprises an enhanced visibility material viewable using the visualization technique.
4. The fixation device of claim 3 , wherein the first distal element comprises an enhanced visibility material viewable using the visualization technique; and
wherein the second distal element comprises an enhanced visibility material viewable using the visualization technique.
5. The fixation device of claim 3 , wherein the visualization technique comprises at least one of fluoroscopy, ultrasound, and echocardiography.
6. The fixation device of claim 1 , wherein the first indicator comprises one or more wire elements; and
wherein the second indicator comprises one or more wire elements.
7. The fixation device of claim 6 , wherein the one or more wire elements of the first indicator comprise an enhanced visibility material viewable using a visualization technique; and
wherein the one or more wire elements of the second indicator comprise an enhanced visibility material viewable using the visualization technique.
8. The fixation device of claim 6 , wherein the one or more wire elements of the first indicator are biased towards the first proximal element; and
wherein the one or more wire elements of the second indicator are biased towards the second proximal element.
9. The fixation device of claim 1 , wherein:
the first indicator is configured to extend outwardly from a side of the first distal element opposite the first target area upon passing through the first distal element, and
the second indicator is configured to extend outwardly from a side of the second distal element opposite the second target area upon passing through the second distal element.
10. The fixation device of claim 9 , wherein:
the first distal element has a first engagement surface defining a first concave recess, the first indicator being positioned at least partially within the concave recess when the first leaflet is not present within the first target area, and
the second distal element has a second engagement surface defining a second concave recess, the second indicator being positioned at least partially within the second concave recess when the second leaflet is not present within the second target area.
11. The fixation device of claim 9 , wherein the first and second indicators are each comprised of wire loops coated with enhanced visibility material visible by a visualization technique and are biased toward the first and second proximal elements, respectively.
12. A fixation device, comprising: a first distal element and a second distal element; a first proximal element moveable relative to the first distal element between a first position of the first proximal element and a second position of the first proximal element to grasp a first leaflet of a heart valve in a first target area defined by the first proximal element and the first distal element; a second proximal element moveable relative to the second distal element between a first position of the first proximal element and a second position of the first proximal element to grasp a second leaflet of the heart valve in a second target area defined by the second proximal element and the second distal element; a first indicator coupled with the first distal element to indicate a presence of the first leaflet in the first target area, wherein the first indicator is moveable from a first configuration to a second configuration by the presence of the first leaflet grasped within the first target area, wherein, in the first configuration of the first indicator, the first indicator extends from a first side of the first distal element and into the first target area, and in the second configuration of the first indicator, the first indicator extends from a second side of the first distal element opposite the first side; and a second indicator coupled with the second distal element to indicate a presence of the second leaflet in the second target area, wherein the second indicator is moveable from a first configuration to a second configuration by the presence of the second leaflet grasped within the second target area, wherein, in the first configuration of the second indicator, the second indicator extends from a first side of the second distal element and into the second target area, and in the second configuration of the second indicator, the second indicator extends from a second side of the second distal element opposite the first side of the second distal element.
13. The fixation device of claim 12 , wherein the first and second indicators are biased toward their respective first configuration.
14. The fixation device of claim 12 , wherein: the first distal element has a first inner surface and a first outer surface, the first inner surface at least partially defining the first target area, and the first outer surface being disposed opposite the first inner surface, wherein the first indicator is configured to pass through the first inner and outer surfaces when transitioning from the first configuration thereof to the second configuration thereof, and the second distal element has a second inner surface and a second outer surface, the second inner surface at least partially defining the second target area, and the second outer surface being disposed opposite the second inner surface, wherein the second indicator is configured to pass through the second inner and second surfaces when transitioning from the first configuration thereof to the second configuration thereof.
15. The fixation device of claim 14 , wherein the first and second inner surfaces are each concavely shaped.
16. The fixation device of claim 14 , wherein the first and second indicators each include a flexible loop.
17. The fixation device of claim 16 , wherein the first and second indicators each include an enhanced visibility material viewable using a visualization technique.