Edge to edge repair device for valves
A valve fixation device may comprise a unitary elongate member that is biased towards a closed configuration wherein at least a pair of tissue engaging surfaces of the elongate member are held adjacent to each other by a bias force. The bias force is at least equal to a valve leaflet grasping force, enabling the fixation device to grasp and retain leaflets as part of cardiac treatment. A delivery tool including a spreader may independently translate the tissue engaging surfaces to enable cardiac leaflets to be captured and retained by and/or between the tissue engaging surfaces. The valve fixation device may include at least two arms, each of which may be independently controlled to grasp and capture opposing leaflets of a valve, such as the anterior and posterior leaflets of a mitral valve, to reduce the size of the valve opening and improve cardiac performance.
1. A fixation device configured and sized for affixing to a heart valve leaflet, the fixation device comprising:
a unitary elongate body having a proximal end and a distal end with a length therebetween, the proximal end having a proximal neck portion comprising a proximal tissue engaging surface, and the distal end having a distal portion with a length, a width, and a thickness, and apportioned to define a plurality of arms each extending distally away from the proximal end of the unitary elongate body to an end of the arm;
wherein:
an arm of the plurality of arms curves to extend the end of the arm proximally toward the proximal end of the unitary elongate body and is configured to have a closed configuration wherein a tissue engaging surface defined along the end of the arm is retained adjacent the proximal tissue engaging surface of the proximal neck portion by a bias force at least equal to a leaflet grasping force; and
the arm of the plurality of arms is movable towards an open configuration wherein the tissue engaging surface of the arm is spaced away from the proximal tissue engaging surface of the proximal neck portion.
2. The leaflet fixation device of claim 1 , wherein each arm of the plurality of arms has a tissue engaging surface along an end thereof biased proximally towards a closed configuration adjacent to the proximal neck portion of the unitary elongate body.
3. The leaflet fixation device of claim 2 , wherein, in the closed configuration, a first arm of the plurality of arms is adjacent to a first proximal tissue engaging surface of the proximal neck portion of the unitary elongate body and a second arm of the plurality of arms is adjacent to a second, opposing proximal tissue engaging surface of the proximal neck portion of the unitary elongate body.
4. The leaflet fixation device of claim 1 , wherein the proximal neck portion, the distal portion, or both include a tissue retention feature configured to penetrate but not puncture tissue, puncture tissue or both.
5. The leaflet fixation device of claim 4 , wherein the tissue retention feature is one of a plurality of tissue retention features disposed on the proximal neck portion, the distal portion or a combination of the proximal neck portion and the distal portion.
6. The leaflet fixation device of claim 4 , wherein the tissue retention feature includes a barb, a hook, a tooth, a tine or a combination thereof.
7. The leaflet fixation device of claim 4 , wherein the tissue retention feature comprises a feature that promotes tissue ingrowth into the unitary elongate body.
8. The leaflet fixation device of claim 1 , wherein each arm of the plurality of arms is configured to move independently from other arms of the plurality of arms.
9. The leaflet fixation device of claim 1 , wherein a weight of the leaflet fixation device is between 50-150 milligrams.
10. The leaflet fixation device of claim 1 , wherein the unitary elongate body comprises a length and a width, and the distal portion of the unitary elongate body is apportioned along its thickness or along its width to define the plurality of arms.
11. The leaflet fixation device of claim 1 , wherein the proximal neck portion is apportioned into a plurality of necks, and wherein the unitary elongate body comprises a biased configuration wherein at least one arm is adjacent to at least one neck.
12. A system comprising:
a heart valve leaflet fixation device having a proximal end and a distal end and comprising:
a unitary elongate body having a first end, a distal end, a first surface extending between the first end and the second end and facing a first direction, and a second surface extending between the first end and the second end and facing a second direction opposite the first direction, the body further comprising a proximal neck portion formed along the proximal end of the fixation device and having a first proximal tissue engaging surface along the first surface, and a first arm having a tissue engaging surface along the first surface and extending distally away from the proximal neck portion and then curving to extend proximally toward the proximal neck portion, wherein the first arm is biased towards a closed configuration with a bias force at least equal to a leaflet grasping force retaining the tissue engaging surface of the first arm adjacent to the first proximal tissue engaging surface of the proximal neck portion;
and
a delivery tool including a spreader mechanism configured to independently translate the first arm between a closed configuration in which the tissue engaging surface of the first arm is retained adjacent to the proximal tissue engaging surface of the proximal neck portion by a bias force, and an open configuration in which the tissue engaging surface of the first arm is spaced away from the proximal tissue engaging surface of the proximal neck portion.
13. The system of claim 12 , wherein the proximal neck portion has a second proximal tissue engaging surface along the second surface, and the body further comprises a second arm having a second tissue-engaging surface along the second surface, the second arm extending distally away from the proximal neck portion and then curving to extend proximally towards the proximal neck portion, wherein the second arm is biased proximally towards a closed configuration with a bias force at least equal to a leaflet grasping force retaining the second distal tissue engaging surface adjacent to the second proximal tissue engaging surface of the proximal neck portion.
14. The system of claim 12 , wherein the spreader mechanism comprises:
a jaw, pivotably coupled to a distal end of the delivery tool, the jaw including a coupler configured to releasably couple the first arm to the jaw;
wherein rotation of the jaw in a first direction pulls the first arm away from the proximal neck portion of the leaflet fixation device to the open configuration to provide a space therebetween configured for valvular tissue; and
wherein rotation of the jaw in a second direction returns the first arm to the closed configuration.
15. The system of claim 12 , wherein the spreader mechanism includes:
a spreader arm, rotatably coupled to a distal end of the delivery tool, the spreader arm disposed to push the first arm away from the proximal neck portion of the leaflet fixation device to the open configuration when rotated in a first direction to provide a space therebetween configured for valvular tissue; and
wherein rotation of the spreader arm in a second direction returns the first arm to the closed configuration.
16. The system of claim 12 , wherein the proximal neck portion, the first arm, or both include a tissue retention feature configured to penetrate but not puncture tissue, puncture tissue, or both, and the spreader mechanism is configured to independently translate the first arm between the closed configuration and the open configuration and to inhibit engagement between a tissue engagement feature and tissue during placement of the leaflet fixation device.
17. A fixation device configured and sized for affixing to a heart valve leaflet and having a proximal end and a distal end, the fixation device comprising:
a unitary elongate body having a first end, a second end, a first surface extending between the first end and the second end and facing a first direction, and a second surface extending between the first end and the second end and facing a second direction opposite the first direction, the body further comprising a proximal neck portion formed along the proximal end of the fixation device and having a first proximal tissue engaging surface along the first surface, and a first arm having a first tissue engaging surface along the first surface;
wherein the first arm extends distally away from the proximal neck portion and then curves to extend proximally toward the proximal neck portion, and is biased towards a closed configuration with a bias force at least equal to a leaflet grasping force retaining the first tissue engaging surface of the first arm adjacent to the first proximal tissue engaging surface of the proximal neck portion.
18. The leaflet fixation device of claim 17 , wherein:
the proximal neck portion has a second proximal tissue engaging surface along the second surface; and
the body further comprises a second arm having a second tissue engaging surface along the second surface and biased proximally towards a closed configuration with the second tissue engaging surface of the second arm adjacent to the second proximal tissue engaging surface of the proximal neck portion.
19. The leaflet fixation device of claim 17 , wherein the proximal neck portion has a second proximal tissue engaging surface along the second surface, and the body further comprises a second arm having a second tissue-engaging surface along the second surface and extending distally away from the proximal neck portion and then curving to extend proximally toward the proximal neck portion, wherein the second arm is biased proximally towards a closed configuration with a bias force at least equal to a leaflet grasping force retaining the second tissue engaging surface of the second arm adjacent to the second proximal tissue engaging surface of the proximal neck portion.
20. The system of claim 17 , wherein the proximal neck portion, the first arm, or both include a tissue retention feature configured to penetrate but not puncture tissue, puncture tissue, or both.