Independent gripper
The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.
1. A fixation system for engaging heart leaflet tissue comprising:
an implantable fixation device comprising:
a pair of fixation elements comprising a first fixation element and a second fixation element, each having a first end, an end opposite the first end, and an engagement surface therebetween to engage tissue of a native heart valve leaflet, the first ends being movably coupled such that the first and second fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other;
a fixation element actuator coupled to the first and second fixation elements and adapted to move the first and second fixation elements between the closed position and the first open position; and
a pair of gripping elements comprising a first gripping element and a second gripping element, each of the first and second gripping elements moveable relative to a respective one of the fixation elements and configured to be moved in opposition to the engagement surface of the respective one of the fixation elements so as to capture the tissue therebetween;
an elongate delivery shaft having a proximal end portion and a distal end portion, wherein the distal end portion of the elongate delivery shaft is releasably coupled to a proximal end portion of the implantable fixation device;
a first gripper actuator releasably coupled to the implantable fixation device and configured to actuate the first gripping element, the first gripper actuator having a first configuration and a second configuration, wherein actuating the first gripper actuator between the first configuration and the second configuration moves the first gripping element with respect to the first fixation element and wherein the first gripper actuator comprises a first gripper line having a proximal end portion, a distal end portion, and an intermediate portion between the proximal and distal end portions,
a second gripper actuator releasably coupled to the implantable fixation device and configured to actuate the second gripping element, the second gripper actuator having a first configuration and a second configuration, wherein actuating the second gripper actuator between the first configuration and the second configuration of the second gripper actuator moves the second gripping element with respect to the second fixation element and wherein the second gripper actuator comprises a second gripper line having a proximal end portion, a distal end portion, and an intermediate portion between the proximal and distal end portions of the second gripper line, wherein
the first gripper line is directly engaged to the first gripping element at the intermediate portion of the first gripper line and is releasable therefrom, and the second gripper line is directly engaged to the second gripping element at the intermediate portion of the second gripper line and is releasable therefrom,
the distal end portion of the first gripper line is directly engaged to the distal end portion of the elongate delivery shaft and is releasable therefrom, and the distal end portion of the second gripper line is directly engaged to the distal end portion of the elongate delivery shaft and is releasable therefrom, and
the first gripper actuator and the second gripper actuator are actuatable between the respective first configuration and second configuration independently of each other.
2. The fixation system of claim 1 , wherein the distal end portions of the first gripper line and the second gripper line are locked in position by placing the distal end portions of the first gripper line and the second gripper line adjacent the distal end portion of the elongate delivery shaft and coupling the distal end portion of the elongate delivery shaft to the proximal end portion of the implantable fixation device.
3. The fixation system of claim 1 , wherein the distal end portion of the first gripper line comprises a narrow portion and a wide portion, and wherein the distal end portion of the second gripper line comprises a narrow portion and a wide portion.
4. The fixation system of claim 3 , wherein the elongate delivery shaft and the implantable fixation device are shaped to form hollow portions when coupled together, the hollow portions configured to receive the wide portion of the first gripper line and the wide portion of the second gripper line.
5. The fixation system of claim 3 , wherein the elongate delivery shaft includes open slots.
6. The fixation system of claim 1 , wherein the distal end portion of the first gripper line comprises a first catch and the distal end portion of the second gripper line comprises a second catch.
7. The fixation system of claim 6 , wherein the first catch comprises a first ball and the second catch comprises a second ball.
8. The fixation system of claim 1 , wherein the fixation element actuator comprises an actuator rod extending through the delivery shaft and into the implantable fixation device to actuate the pair of fixation elements.
9. The fixation system of claim 8 , wherein the delivery shaft comprises an opening portion and wherein the distal end portion of the first gripper line is disposed in the opening portion and fixed when the actuator rod is extended into the implantable fixation device.
10. The fixation system of claim 9 , wherein the distal end portion of the first gripper line is released when the actuator rod is withdrawn from the implantable fixation device.
11. The fixation system of claim 10 , wherein the distal end portion of the second gripper line is disposed in the opening portion and fixed when the actuator rod is extended into the implantable fixation device.
12. The fixation system of claim 11 , wherein the distal end portion of the second gripper line is released when the actuator rod is withdrawn from the implantable fixation device.
13. The fixation system of claim 8 , wherein the proximal end portion of the implantable fixation device comprises a pair of apertures, wherein the distal end portion of the elongate delivery shaft comprises a pair of L-shaped ends resiliently biased to fit into the pair of apertures.
14. The fixation system of claim 13 , wherein the L-shaped ends are fixed to the pair of apertures when the actuator rod is extended into the implantable fixation device.
15. The fixation system of claim 13 , wherein the L-shaped ends are released from the pair of apertures when the actuator rod is withdrawn from the implantable fixation device.
16. A fixation system for engaging heart leaflet tissue comprising:
an implantable fixation device comprising:
a pair of fixation elements comprising a first fixation element and a second fixation element, each having a first end, an end opposite the first end, and an engagement surface therebetween to engage tissue of a native heart valve leaflet, the first ends being movably coupled such that the first and second fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other;
a fixation element actuator coupled to the first and second fixation elements and adapted to move the first and second fixation elements between the closed position and the first open position; and
a pair of gripping elements comprising a first gripping element and a second gripping element, each of the first and second gripping elements moveable relative to a respective one of the fixation elements and configured to be moved in opposition to the engagement surface of the respective one of the fixation elements so as to capture the tissue therebetween;
an elongate delivery shaft having a proximal end portion and a distal end portion, wherein the distal end portion of the elongate delivery shaft is releasably coupled to a proximal end portion of the implantable fixation device;
a first gripper actuator releasably engaged to the implantable fixation device and configured to actuate the first gripping element, the first gripper actuator having a first configuration and a second configuration, wherein actuating the first gripper actuator between the first configuration and the second configuration moves the first gripping element with respect to the first fixation element and wherein the first gripper actuator comprises a first gripper line having a proximal end portion, a distal end portion, and an intermediate portion extending between the proximal end portion and distal end portion, the intermediate portion being releasably engaged to the first gripping element,
a second gripper actuator releasably engaged to the implantable fixation device and configured to actuate the second gripping element, the second gripper actuator having a first configuration and a second configuration, wherein actuating the second gripper actuator between the first configuration and the second configuration of the second gripper actuator moves the second gripping element with respect to the second fixation element and wherein the second gripper actuator comprises a second gripper line having a proximal end portion, a distal end portion, and an intermediate portion extending between the proximal and distal end portions of the second gripper line, the intermediate portion of the second gripper line being releasably engaged to the second gripping element, wherein
the respective distal end portions of the first and second gripper lines are directly connected to the distal end portion of the elongate delivery shaft so as to prohibit relative movement thereof and are releasable therefrom, and
the first gripper actuator and the second gripper actuator are actuatable between the respective first configuration and second configuration independently of each other.
17. The fixation system of claim 16 , wherein the distal end portions of the first gripper line and the second gripper line are locked in position by placing the distal end portions of the first gripper line and the second gripper line adjacent the distal end portion of the elongate delivery shaft and coupling the distal end portion of the elongate delivery shaft to the proximal end portion of the implantable fixation device.
18. The fixation system of claim 16 , wherein the distal end portion of the first gripper line comprises a narrow portion and a wide portion, and wherein the distal end portion of the second gripper line comprises a narrow portion and a wide portion.
19. The fixation system of claim 18 , wherein the elongate delivery shaft and the implantable fixation device are shaped to form hollow portions when coupled together, the hollow portions configured to receive the wide portion of the first gripper line and the wide portion of the second gripper line.
20. The fixation system of claim 18 , wherein the elongate delivery shaft includes open slots.