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 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, a second end opposite the first end, and an engagement surface therebetween configured to engage tissue, the pair of fixation elements being moveable between a first position and a second 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 tissue therebetween; and
a delivery device comprising:
a delivery catheter having a proximal end portion and a distal end portion, the distal end portion of the delivery catheter being releasably coupled to the implantable fixation device,
an actuator rod extending from the distal end portion of the delivery catheter and into engagement with the implantable fixation device, the actuator rod being configured to move the first and second fixation elements between their respective first and second positions upon the actuation of the actuator rod,
a first gripper line extending through the delivery catheter and having a proximal end portion defining a proximal terminal end of the first gripper line, a distal end portion defining a distal terminal end of the first gripper line, and an intermediate portion between the proximal and distal end portions of the first gripper line, the intermediate portion of the first gripper line engaging the first gripping element, and the distal end portion of the first gripper line being releasably secured to the distal end portion of the delivery catheter via the actuator rod, wherein actuating the first gripper line moves the first gripping element with respect to the first fixation element, and
a second gripper line extending through the delivery catheter and having a proximal end portion defining a proximal terminal end of the second gripper line, a distal end portion defining a distal terminal end of the second gripper line, and an intermediate portion between the proximal and distal end portions of the second gripper line, the intermediate portion of the second gripper line engaging the second gripping element, and the distal end portion of the second gripper line being releasably secured to the distal end portion of the delivery catheter via the actuator rod, wherein actuating the second gripper line moves the second gripping element with respect to the second fixation element.
2 . The fixation system of claim 1 , wherein the actuator rod is configured to be disengaged from the implantable fixation device, and wherein disengaging the actuator rod from the implantable fixation device releases the distal end portion of the respective first gripper line and the second gripper line from the distal end portion of the delivery catheter and from the respective first and second gripping elements.
3 . The fixation system of claim 2 , wherein the actuator rod has a threaded distal end configured to threadedly engage the implantable fixation device.
4 . The fixation system of claim 3 , wherein:
the distal end portion of the delivery catheter includes a first lumen and first and second windows extending through the distal end portion of the delivery catheter and into communication with the first lumen, and
the distal end portion of each of the first and second gripper lines extends through the respective first and second windows such that the distal terminal ends are disposed within the first lumen.
5 . The fixation system of claim 4 , wherein the actuator rod is disposed within the first lumen and is axially moveable therein between a distal position and a proximal position, wherein in the distal position, the actuator rod extends distal relative to the first and second windows so as to intersect the first and second windows, and in the proximal position, the actuator rod is positioned proximal relative to the first and second windows.
6 . The fixation system of claim 5 , wherein the delivery catheter includes second and third lumens, the first gripper line extends through the second lumen, and the second gripper line extends through the second lumen.
7 . The fixation system of claim 6 , wherein the distal end portion of the delivery catheter includes a shaft releasably coupled to the implantable fixation device, the first lumen extends through the shaft, and the first and second windows extend transversely through the shaft.
8 . The fixation system of claim 7 , wherein the shaft includes first and second liners hingedly connected thereto and extending over the first and second windows.
9 . The fixation system of claim 1 , wherein the delivery device includes a handle coupled to the proximal end portion of the delivery catheter, and the proximal terminal end of each of the first and second gripper lines is secured to the handle.
10 . The fixation system of claim 1 , wherein each of the first and second gripping elements includes a line loop, and the intermediate portion of each of the first and second gripper lines engages the line loop of the respective first and second gripping elements.
11 . A fixation system 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, a second end opposite the first end, and an engagement surface therebetween configured to engage tissue, the pair of fixation elements being moveable between a first position and a second 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; and
a delivery device comprising:
a delivery catheter having a proximal end portion and a distal end portion, the distal end portion of the delivery catheter having a shaft releasably coupled to the implantable fixation device, the shaft having a shaft lumen and first and second openings extending through the shaft and into communication with the shaft lumen,
an actuator rod extending through the shaft lumen and into engagement with the implantable fixation device, the actuator rod being configured to move the first and second fixation elements between their respective first and second positions upon the actuation of the actuator rod,
a first gripper line having a proximal end portion, a distal end portion, and an intermediate portion between the proximal and distal end portions of the first gripper line, the intermediate portion of the first gripper line engaging the first gripping element, and the distal end portion of the first gripper line extending into the first opening in the shaft so as to be at least partially disposed within the shaft lumen where it is releasably secured by the actuator rod, wherein actuating the first gripper line moves the first gripping element with respect to the first fixation element, and
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, the intermediate portion of the second gripper line engaging the first second gripping element, and the distal end portion of the second gripper line extending into the second opening so as to be at least partially disposed within the shaft lumen where it is releasably secured by the actuator rod, wherein actuating the second gripper line moves the second gripping element with respect to the second fixation element.
12 . The fixation system of claim 11 , wherein implantable fixation device includes a coupling member having a pair of apertures, and the shaft includes a pair of flexible arms moveable from a first position in which the arms engage the apertures to couple the shaft to the implantable fixation device and a second position in which the flexible arms are disengaged from the apertures to release the fixation device from the shaft, the flexible arms being biased toward the second position.
13 . The fixation system of claim 12 , wherein the actuator rod is moveable within the shaft lumen from a first position and a second position, wherein when the actuator rod is in the first position, the actuator rod is disposed between the flexible arms and pushes them into their first position, and when the actuator rod is in the second position, the actuator rod is removed from between the flexible arms allowing them to return to their second position.
14 . The fixation system of claim 13 , wherein, when the actuator rod is in the first position, the actuator rod is positioned between the first and second openings to secure the distal end portion of each of the first and second gripper lines within their respective first and second openings, and when the actuator rod is in the second position, the actuator rod is removed from between the first and second openings allowing the first and second gripper lines to be released from the shaft and their respective first and second gripping elements.
15 . The fixation system of claim 14 , wherein the shaft includes first and second hinged liners that extend over the first and second openings, and when the actuator rod is in the first position, the actuator rod is disposed between the hinged liners which pushes the hinged liners into engagement with the first and second gripper lines to trap the first and second gripper lines within their respective first and second openings, and when the actuator rod is in the second position, the actuator rod is removed from between the hinged liners which releases the first and second gripper lines from the shaft.