Heart valve prosthesis delivery system
The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.
1. A valve prosthesis delivery device for delivering a valve prosthesis, the valve prosthesis comprising a valve frame and a valve anchor, the delivery device comprising:
an elongate core member extending along a longitudinal axis of the device;
a distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure being coupled to the core member and comprising a distal lumen, the distal enclosure being configured to receive a distal portion of the valve frame within the distal lumen in a compressed configuration, the proximal enclosure being coupled to the core member proximal to the distal enclosure and comprising a proximal lumen, the proximal enclosure being configured to receive a proximal portion of the valve frame within the proximal lumen in a compressed configuration;
a sheath component having a sheath lumen configured to receive the valve anchor, wherein in a delivery configuration, the sheath component supports the valve anchor in a position longitudinally spaced apart from and proximal to the proximal lumen of the proximal enclosure, the sheath component being proximally retractable along the core member relative to the proximal enclosure for permitting expansion of the valve anchor; and
a plunger mechanism and a biasing means disposed within the distal lumen of the distal carrier assembly, the plunger mechanism being moveable between a distal position and a proximal position within the distal lumen, the plunger mechanism being biased toward the proximal position by the biasing means for urging the valve frame out of the distal lumen.
2. The delivery device of claim 1 , wherein the plunger mechanism comprises a plunger head that is moveable between the distal position and the proximal position within the distal lumen, the plunger head being biased toward the proximal position by the biasing means.
3. The delivery device of claim 2 , wherein in the proximal position, the plunger head extends at least partially proximally out of the distal lumen.
4. The delivery device of claim 2 , wherein in the proximal position, an outer surface of the plunger head is in contact with both an inner surface of the distal lumen and an inner surface of the proximal lumen when the proximal enclosure is distally advanced over the plunger head.
5. The delivery device of claim 2 , further comprising the valve prosthesis, wherein when the valve frame is positioned within the distal lumen, the plunger head is urged to the distal position.
6. The delivery device of claim 2 , wherein the biasing means comprises a spring.
7. The delivery device of claim 6 , wherein the biasing means comprises a spring, the spring being interposed between a proximal face of the distal enclosure and a distal face of the plunger head.
8. The delivery device of claim 1 , wherein the plunger mechanism comprises a proximal portion that tapers in a proximal direction.
9. The delivery device of claim 8 , wherein the plunger mechanism comprises a plunger head with a plurality of petals extending from the plunger head, wherein the plurality of petals each form a ramped surface.
10. The delivery device of claim 9 , wherein the plurality of petals are configured to deflect radially inward within the distal lumen.
11. The delivery device of claim 9 , wherein the plurality of petals are configured to deflect radially outward when a portion of the plurality of petals exits the distal enclosure.
12. The delivery device of claim 11 , wherein in the proximal position, the plunger mechanism extends at least partially proximally out of the distal lumen, the proximal enclosure being distally advanceable over the ramped surfaces of the plurality of petals to align an outer surface of the distal enclosure with an outer surface of the proximal enclosure for facilitating removal of the delivery device from a patient.
13. The delivery device of claim 1 , wherein the sheath lumen and the proximal lumen of the proximal enclosure have about the same diameter.
14. A valve prosthesis delivery device for delivering a valve prosthesis, the valve prosthesis comprising a valve frame and a valve anchor, the delivery device comprising:
an elongate core member;
a distal carrier assembly being coupled to the core member and comprising a distal enclosure and a proximal enclosure, the distal enclosure having a distal lumen configured to receive a distal portion of the valve frame therein, the proximal enclosure having a proximal lumen configured to receive a proximal portion of the valve frame therein;
a sheath component comprising a sheath lumen configured to receive at least a portion of the valve anchor and a distal end portion that is configured to proximally abut the proximal enclosure, the sheath component being proximally retractable relative to the proximal enclosure for permitting expansion of the valve anchor;
a plunger mechanism; and
a biasing means disposed within the distal lumen of the distal carrier assembly, the plunger mechanism being moveable between a distal position and a proximal position within the distal lumen, the plunger mechanism being biased toward the proximal position by the biasing means for urging the valve frame out of the distal lumen.
15. The delivery device of claim 14 , wherein the proximal enclosure comprises a proximal section that extends within the sheath lumen when the sheath component distal end portion abuts the proximal enclosure.
16. The delivery device of claim 14 , wherein the sheath component encloses the valve anchor therein when the sheath component abuts the proximal enclosure.
17. A valve prosthesis delivery device for delivering a valve prosthesis, the valve prosthesis comprising a valve frame and a valve anchor, the delivery device comprising:
an elongate core member extending along a longitudinal axis of the device;
a distal carrier assembly being coupled to the core member and comprising a distal enclosure and a proximal enclosure, proximal to the distal enclosure, the distal enclosure comprising a distal lumen configured to receive a distal portion of the valve frame, the proximal enclosure comprising a proximal lumen configured to receive a proximal portion of the valve frame; and
a plunger mechanism and a biasing means disposed within the distal lumen of the distal carrier assembly, the plunger mechanism being moveable between a distal position and a proximal position within the distal lumen, the plunger mechanism being biased toward the proximal position by the biasing means for urging the valve frame out of the distal lumen, wherein the plunger mechanism comprises a plunger head with a plurality of petals extending from the plunger head.
18. The delivery device of claim 17 , wherein each of the plurality of petals comprises a ramped surface.
19. The delivery device of claim 18 , wherein each of the plurality of petals is configured to deflect radially inward within the distal lumen.
20. The delivery device of claim 18 , wherein each of the plurality of petals is configured to deflect radially outward when a portion of the plurality of petals exits the distal enclosure.
21. The delivery device of claim 20 , wherein each of the plurality of petals comprises an engagement tooth configured to engage with the distal enclosure in the proximal position such that the plunger mechanism extends proximally out of the distal lumen and the proximal enclosure is distally advanceable over the ramped surfaces of the plurality of petals to align an outer surface of the distal enclosure with an outer surface of the proximal enclosure for facilitating removal of the delivery device from a patient.