Systems and methods for anchoring an implant
The invention relates in some aspects to a device for use in anchoring an implant, including anchors, sutures, implants, clips, tools, lassos, and methods of anchoring among other methods. Anchors as disclosed herein could be utilized to secure a coaptation assistance device, an annuloplasty ring, an artificial valve, cardiac patch, sensor, pacemaker, or other implants. The implant could be a mitral valve ring or artificial mitral valve in some embodiments.
1. A system comprising:
an anchor comprising a proximal end and a distal end, wherein the distal end is configured to be secured to tissue, wherein the anchor comprises a cross pin, wherein the anchor comprises a helical shaft,
a coaptation assistance device comprising a first surface configured to be disposed toward a posterior leaflet of a valve when implanted and a second surface, opposed to the first surface, the second surface configured to be disposed toward an anterior leaflet of the valve when implanted, where the first surface and the second surface are bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, the coaptation assistance device comprising a support structure comprising a shape memory material configured to maintain the shape and functionality of the coaptation assistance device as the heart contracts and dilates and exerts pressure on the coaptation assistance device, wherein the anchor is configured to secure the coaptation assistance device to an annulus, wherein the coaptation assistance device is configured to directly engage the anterior leaflet for coaptation without reshaping the annulus, wherein the coaptation assistance device provides a new coaptation surface over the posterior leaflet, wherein opposition or engagement of coaptation assistance device and the anterior leaflet against each other provides closure or sealing of the valve,
an anchor driver comprising a distal housing and a torque shaft, wherein the cross pin of the anchor is configured to fit into a cutout at a distal end of the torque shaft, wherein the anchor is disposed within the distal housing during delivery, wherein the anchor is configured to be rotated by the torque shaft relative to the distal housing to secure the anchor into tissue of the annulus, and
a loading suture configured to hold the anchor in position while the anchor is being driven into tissue, wherein the loading suture is releasably secured to the anchor such that the loading suture is configured to slip from the anchor to release the loading suture from the anchor after the anchor is driven into tissue.
2. The system of claim 1 , wherein the distal housing comprises a tapered portion.
3. The system of claim 1 , wherein the anchor driver is configured to secure the loading suture during delivery.
4. The system of claim 3 , wherein the loading suture is configured to be loosened once the anchor is secured.
5. The system of claim 1 , wherein the distal end of the anchor comprises a sharpened tip.
6. The system of claim 1 , wherein the helical shaft comprises an outer diameter of between about 3-5 mm.
7. The system of claim 1 , wherein the helical shaft comprises a wire having a diameter between about 0.010″ and about 0.030″.
8. The system of claim 1 , wherein the helical shaft has a pitch between about 1 mm and about 2 mm.
9. The system of claim 1 , wherein the helical shaft has a gap between coils between about 0.5 mm and about 2 mm.
10. A system comprising:
an anchor comprising a proximal end and a distal end, wherein the distal end is configured to engage tissue, wherein the anchor comprises a cross pin and a helical shaft,
a coaptation assistance device comprising a first surface configured to be disposed toward a posterior leaflet when implanted and a second surface configured to be disposed toward an anterior leaflet when implanted, wherein the anchor is configured to secure the coaptation assistance device to an annulus,
an anchor driver comprising a distal housing and a torque shaft, wherein the cross pin of the anchor is configured to fit into a forked end of the torque shaft, wherein the anchor is configured to be delivered to a tissue site within the distal housing, wherein the anchor is configured to be rotated by the torque shaft to engage tissue of the annulus, and
a loading suture engaging the anchor when the anchor is rotated, the loading suture extending through the anchor driver and extending proximally from the anchor driver, wherein the anchor driver is configured to apply tension on the loading suture during delivery of the anchor, wherein tension on the loading suture holds the anchor against the torque shaft during rotation of the anchor.
11. The system of claim 10 , wherein the distal housing comprises a tapered portion.
12. The system of claim 10 , wherein the distal end of the anchor comprises a sharpened tip.
13. The system of claim 10 , wherein the helical shaft comprises an outer diameter of between about 3-5 mm.
14. The system of claim 10 , wherein the helical shaft comprises a wire having a diameter between about 0.010″ and about 0.030″.
15. The system of claim 10 , wherein the helical shaft has a pitch between about 1 mm and about 2 mm.
16. The system of claim 10 , wherein the helical shaft has a gap between coils between about 0.5 mm and about 2 mm.
17. A system comprising:
a primary anchor comprising a proximal end and a distal end, wherein the distal end is configured to be driven into tissue, wherein the primary anchor comprises a cross pin, wherein the anchor comprises a helical shaft,
a coaptation assistance device comprising a support structure comprising a shape memory material configured to maintain the shape and functionality of the coaptation assistance device, wherein the coaptation assistance device comprises a tubular extension connected to the support structure and extending upward from the support structure, wherein the tubular extension is configured to receive the primary anchor, wherein the primary anchor is configured to secure the coaptation assistance device to an annulus, wherein the coaptation assistance device comprises a superior edge configured to reside within the annulus, an inferior edge configured to extend toward the ventricle, and lateral edges extending between the superior edge and the inferior edge, wherein the lateral edges taper inward from the superior edge to the inferior edge such that the coaptation assistance device is generally triangular, wherein the coaptation assistance device comprising a first surface configured to be overlie a posterior leaflet of a valve when implanted and a second surface, opposed to the first surface, configured to be disposed toward an anterior leaflet of the valve when implanted, where the first surface and the second surface are bounded by the superior edge, the inferior edge, the lateral edges, wherein the coaptation assistance device provides a new coaptation surface over the posterior leaflet, wherein opposition or engagement of coaptation assistance device and the anterior leaflet against each other provides closure or sealing of the valve,
an anchor driver comprising a distal housing and a torque shaft, wherein the cross pin of the primary anchor is configured to fit within a distal end of the torque shaft, wherein the torque shaft and the primary anchor are disposed within the distal housing, wherein the torque shaft and the primary anchor are rotatable relative to the distal housing to drive the primary anchor into tissue, and
at least one secondary anchor spaced from the tubular extension and the primary anchor, the one or more secondary anchors having a different configuration than the primary anchor.
18. The system of claim 17 , wherein the anchor driver is configured to secure a suture during delivery.
19. The system of claim 17 , wherein the helical shaft comprises an outer diameter of between about 3-5 mm.
20. The system of claim 17 , wherein the helical shaft comprises a wire having a diameter between about 0.010″ and about 0.030″.