Medical device and delivery system for modification of left atrial appendage and methods thereof
Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.
1. A medical device delivery system for occluding a left atrial appendage of a heart, the medical device delivery system comprising:
a medical device including an occluder portion and an anchor portion each independently moveable between a non-deployed position and a deployed position, the anchor portion, upon being moved to the deployed position, is at least partially distal of a distal most end of the occluder portion;
a delivery catheter with an anchor tether extending through a lumen defined through the delivery catheter, the anchor tether coupled to the medical device;
an actuation assembly coupled to a handle housing, the actuation assembly including:
an actuation member; and
an anchor operator moveable by actuating the actuation member, the anchor operator moveable between a proximal position and a distal position relative to the handle housing, wherein, upon the occluder portion being maintained in the deployed position, movement of the anchor operator between the proximal position and the distal position moves the anchor portion between the non-deployed position and the deployed position;
a release assembly coupled to the handle housing, the release assembly including:
a release knob, the release knob configured to be rotatably movable from a release knob first position to a release knob second position, and the release knob configured to be linearly moveable from the release knob second position to a release knob third position;
a release enable rod coupled to the release knob and configured to facilitate the release knob to be moved dependent upon a position of the actuation assembly;
an anchor release member operatively coupled to the release enable rod and coupled to the anchor tether; and
an occluder release member coupled to an occluder tether.
2. The system of claim 1 , wherein the delivery catheter defines a central lumen and a secondary lumen extending longitudinally therethrough, the anchor tether extending through the central lumen and the occluder tether extending through the secondary lumen.
3. The system of claim 1 , further comprising a sheath with a lumen extending longitudinally therethrough, the medical device being moveable through the sheath to advance the medical device to the left atrial appendage.
4. The system of claim 3 , wherein the sheath comprises a sheath hub at a proximal end of the sheath, the sheath hub sized and configured to advance the medical device therethrough, the sheath hub including transparent material to enable viewability through the sheath hub.
5. The system of claim 3 , wherein the sheath comprises a sheath hub at a proximal end of the sheath, the sheath hub having a valve configuration including an open position and a closed position, the open position configured to facilitate advancing the medical device through the valve configuration and the closed position configured to prevent back-flow of blood from the sheath hub.
6. The system of claim 3 , wherein the occluder portion is distal a distal end of the delivery catheter and is moved from the non-deployed position to the deployed position by the sheath being moved proximally.
7. The system of claim 3 , wherein the occluder portion is moveable between the non-deployed position and the deployed position with movement of the sheath.
8. The system of claim 1 , wherein the anchor portion in the non-deployed position is at least partially pulled into and proximal a distal end of the delivery catheter; and the anchor portion in the deployed position is moved out of the distal end of the delivery catheter.
9. The system of claim 1 , wherein the anchor portion comprises multiple engaging members extending therefrom, the engaging members sized and configured to substantially prevent proximal and distal movement of the medical device relative to the left atrial appendage.
10. The system of claim 1 , wherein movement of the release knob from the release knob first position to the release knob second position operatively couples the release enable rod to the occluder release member.
11. The system of claim 10 , wherein movement of the release knob from the release knob second position to the release knob third position simultaneously moves both the anchor release member and the occluder release member to facilitate simultaneous detachment of the anchor tether and the occluder tether from the medical device.
12. The system of claim 1 , wherein the release enable rod includes a flat portion configured to prevent rotation of the release knob when the anchor operator is movable by the actuation knob.
13. A medical device delivery system for occluding a left atrial appendage of a heart, the medical device delivery system comprising:
a medical device including an occluder portion and an anchor portion, the anchor portion configured to be retractable with the occluder portion maintained in a deployed position;
a delivery catheter with one or more tethers extending through one or more lumens defined through the delivery catheter, the one or more tethers coupled to the medical device;
an actuation assembly coupled to a handle housing, the actuation assembly including:
an actuation member;
an anchor operator moveable by the actuation member between one or more proximal positions and a distal position, the anchor operator coupled to at least one of the one or more tethers, wherein, upon the occluder portion being maintained in the deployed position, movement of the anchor operator between the one or more proximal positions and the distal position moves the anchor portion between a retractable position and a deployed position, the anchor portion, upon being moved to the deployed position, is at least partially distal of the distal most end of the occluder portion;
a release assembly coupled to the handle housing, the release assembly including:
a release knob, the release knob configured to be rotatably movable from a release knob first position to a release knob second position, and the release knob configured to be linearly moveable from the release knob second position to a release knob third position;
a release enable rod coupled to the release knob and configured to facilitate the release knob to be moved dependent upon a position of the actuation assembly;
an anchor release member operatively coupled to the release enable rod and coupled to the anchor tether; and
an occluder release member coupled to an occluder tether.
14. The system of claim 13 , wherein the anchor portion and the occluder portion are configured to be moveable between deployed and non-deployed positions independent of each other.
15. The system of claim 13 , further comprising a sheath with a lumen extending longitudinally therethrough, the medical device being moveable through the sheath to advance the medical device to the left atrial appendage.
16. The system of claim 15 , wherein the occluder portion is moveable between a non-deployed position and the deployed position with movement of the sheath.
17. The system of claim 15 , wherein the occluder portion is distal a distal end of the delivery catheter and is moved from a non-deployed position to the deployed position by the sheath being manually moved proximally.
18. The system of claim 13 , wherein the anchor portion in the retracted position is at least partially pulled into and proximal a distal end of the delivery catheter; and the anchor portion in the deployed position is moved out of the distal end of the delivery catheter.
19. The system of claim 13 , wherein the anchor portion comprises multiple engaging members extending therefrom, the engaging members sized and configured to substantially prevent proximal and distal movement of the medical device relative to the left atrial appendage.