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 delivery device comprising:
a distal assembly comprising:
a core member extending along a longitudinal axis of the assembly;
a distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure being coupled to the core member and configured to cover a distal portion of a valve frame of a valve prosthesis, the proximal enclosure being slidably coupled to the core member and configured to cover a proximal portion of the valve frame, wherein the proximal enclosure is separable relative to the distal enclosure;
a proximal sheath, proximal to the distal carrier assembly, extending along the core member and configured to cover at least a portion of a valve anchor of the valve prosthesis; and
a control unit comprising a control handle, coupled to the core member, and configured to control an operation of the distal assembly, the control unit further comprising:
a first control element coupled to the control handle and configured to deflect the distal carrier assembly for steering the delivery device during advancement into a body lumen;
a second control element coupled to the control handle and configured to actuate the proximal sheath for proximally retracting the proximal sheath relative to the distal carrier assembly and the valve anchor for exposing the valve anchor; and
a third control element coupled to the control handle and configured to actuate a grasper mechanism for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor and the distal carrier assembly for permitting expansion of the valve frame.
2. The delivery device of claim 1 , wherein actuation of the first control element axially deflects the distal carrier assembly relative to the core member.
3. The delivery device of claim 2 , wherein rotation of the second control element distally disengages the grasper mechanism from the valve anchor.
4. The delivery device of claim 1 , wherein the valve anchor and the valve frame are movably attached and moveable between a disengaged position and an engaged position, the disengaged position allowing variable range of movement between the valve frame and the valve anchor, the engaged position providing a fixed range of movement between the valve frame and the valve anchor.
5. The delivery device of claim 4 , wherein rotation of the third control element in a first direction axially translates the distal enclosure in a first direction relative to the core member.
6. The delivery device of claim 5 , wherein rotation of the third control element in a second direction axially translates the distal enclosure in a second direction relative to the core member.
7. The delivery device of claim 1 , wherein the rotation of the third control element in a first direction axially separates the proximal enclosure from the distal enclosure uncovering the proximal and distal portions of the valve frame and permitting expansion of the valve frame, and wherein rotation of the third control element in a second direction axially draws the proximal enclosure toward the distal enclosure.
8. The delivery device of claim 1 , wherein the core member comprises a hollow shaft.
9. The delivery device of claim 1 , wherein the first control element comprises a knob that is rotatable about a longitudinal axis of the control unit.
10. The delivery device of claim 1 , wherein the second control element comprises a knob that is rotatable about a longitudinal axis of the control unit and translatable along the control handle.
11. The delivery device of claim 1 , wherein the third control element is actuatable via translation along the control handle to actuate the grasper mechanism for longitudinally moving the valve anchor relative to the core member.
12. The delivery device of claim 10 , wherein distal translation of the third control element distally advances the grasper mechanism relative to the proximal sheath to facilitate manipulation of the valve anchor.
13. The delivery device of claim 1 , wherein rotation of the third control element axially translates the proximal enclosure of the distal carrier assembly relative to the core member for exposing the valve frame.
14. The delivery device of claim 1 , wherein the grasper mechanism comprises a plurality of grasper arms coupled to a respective engagement area of the valve anchor.
15. The delivery device of claim 13 , wherein the distal carrier assembly comprises a plunger mechanism and the distal enclosure of the distal carrier assembly has a distal lumen, the plunger mechanism being slidable within the distal lumen of the distal enclosure to urge the distal portion of the valve frame proximally out of the distal lumen after the proximal enclosure is moved proximally relative to the distal enclosure.
16. The delivery device of claim 1 , wherein the first control element is positioned distal to the second control element along the control handle.
17. A valve delivery device comprising:
a core member extending along a longitudinal axis of the assembly;
a distal assembly comprising a distal carrier assembly comprising a first enclosure and a second enclosure, the first enclosure being coupled to the core member and configured to cover a first portion of a valve frame of a valve prosthesis, the second enclosure being slidably coupled to the core member and configured to cover a second portion of the valve frame, and a proximal sheath configured to cover at least a portion of a valve anchor of the valve prosthesis; and
a control unit comprising a control handle, a first control element coupled to the control handle and configured to deflect the distal carrier assembly, a second control element coupled to the control handle and configured to actuate the proximal sheath for proximally retracting the proximal sheath relative to the distal carrier assembly and the valve anchor for exposing the valve anchor, and a third control element coupled to the control handle and configured to actuate a grasper mechanism for longitudinally moving the valve anchor relative to the core member, wherein the third control element is rotatable relative to the control handle to separate the second enclosure from the first enclosure to uncover the first and second portions of the valve frame and permitting expansion of the valve frame.
18. A valve delivery device comprising:
a distal assembly comprising:
a core member;
a distal carrier assembly coupled to the core member and comprising a distal enclosure and a proximal enclosure, the distal enclosure being coupled to the core member and configured to cover a distal portion of a valve prosthesis, the proximal enclosure being slidably coupled to the core member and configured to cover a proximal portion of the valve prosthesis and being separable relative to the distal enclosure for permitting release of the valve prosthesis; and
a proximal sheath, proximal to the distal carrier assembly, extending along the core member and abutting a proximal end portion of the distal carrier assembly; and
a control unit comprising a control handle, coupled to the core member, for controlling an operation of the distal assembly, the control unit further comprising:
a first control element coupled to the control handle and configured to deflect the distal carrier assembly;
a second control element coupled to the control handle and configured to actuate the proximal sheath; and
a third control element coupled to the control handle and configured to actuate a grasper mechanism for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor and the distal carrier assembly for permitting expansion of the valve frame.
19. The delivery device of claim 18 , wherein the proximal enclosure is slidably coupled to the core member.
20. The delivery device of claim 18 , wherein the control unit is configured to axially separate the proximal enclosure from the distal enclosure and axially draw the proximal enclosure toward the distal enclosure.