Fracturing calcifications in heart valves
A device for fracturing calcifications in heart valves including an expandable stabilizer and expandable impactor arms assembled on and deployed by a delivery system, wherein the delivery system is operable to move the impactor arms, while in an expanded position, with respect to the stabilizer with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between the stabilizer and the impactor arms.
1. A method for heart valve treatment comprising:
providing a first heart valve treatment member movable along a first shaft portion and comprising at least one expandable, non-inflatable member;
providing a second heart valve treatment member movable along a second shaft portion and comprising at least one expandable, non-inflatable member; and
wherein said first and second heart valve treatment members are movable between first and second structural positions along said first and second shaft portions, respectively; and
in the first structural portion, causing said first heart valve treatment member to be positioned on a proximal side of a heart valve leaflet and causing said second heart valve treatment member to be positioned on a distal side of the heart valve leaflet, and wherein there is a first gap between said first and second heart valve treatment members, said first gap being sized such that none of said first and second heart valve treatment members fractures a portion of the heart valve leaflet, and
in the second structural position, causing said at least one expandable, non-inflatable member of said first heart valve treatment member to be in a first expanded shape in which it extends outwards from said first shaft portion at an acute angle with respect to said first shaft portion, and said at least one expandable, non-inflatable member of said second heart valve treatment member to be in a second expanded shape in which a portion of said second heart valve treatment member extends outwards from said second shaft portion at an obtuse angle relative to said acute angle, such that there is a second gap between said first and second heart valve treatment members, said second gap being smaller than said first gap and said second gap being sized such that both of said first and second heart valve treatment members contact the heart valve leaflet and said first heart valve treatment member comprises a fracture edge located on an outer surface thereof directed at said acute angle towards the heart valve leaflet; and
fracturing a portion of the heart valve leaflet by axial movement of said first heart valve treatment member, with said fracture edge remaining at said acute angle, towards said second heart valve treatment member which remains expanded at said obtuse angle.
2. The method according to claim 1 , wherein said fracture edge pulverizes the portion of the heart valve leaflet.
3. The method according to claim 1 , wherein said fracture edge breaks the portion of the heart valve leaflet.
4. The method according to claim 1 , wherein said fracture edge grinds the portion of the heart valve leaflet.
5. The method according to claim 1 , wherein said fracture edge chops the portion of the heart valve leaflet.
6. The method according to claim 1 , wherein said fracture edge cuts the portion of the heart valve leaflet.
7. A heart valve treatment device comprising:
a first heart valve treatment member movable along a first shaft portion and comprising at least one expandable, non-inflatable member;
a second heart valve treatment member movable along a second shaft portion and comprising at least one expandable, non-inflatable member; and
wherein said first and second heart valve treatment members are movable between first and second structural positions along said first and second shaft portions, respectively;
wherein in the first structural position, said first heart valve treatment member is positioned on a proximal side of a heart valve leaflet and said second heart valve treatment member is positioned on a distal side of the heart valve leaflet, and wherein there is a first gap between said first and second heart valve treatment members, said first gap being sized such that none of said first and second heart valve treatment members fractures a portion of the heart valve leaflet, and
in the second structural position, said at least one expandable, non-inflatable member of said first heart valve treatment member is in a first expanded shape in which it extends outwards from said first shaft portion at an acute angle with respect to said first shaft portion, and said at least one expandable, non-inflatable member of said second heart valve treatment member is in a second expanded shape in which a portion of said second heart valve treatment member extends outwards from said second shaft portion at an obtuse angle relative to said acute angle, and here is a second gap between said first and second heart valve treatment members, said second gap being smaller than said first gap and said second gap being sized such that both of said first and second heart valve treatment members contact the heart valve leaflet and said first heart valve treatment members comprises a fracture edge located on an outer surface thereof directed at said acute angle towards the heart valve leaflet which is configured to fracture a portion of the heart valve leaflet by axial movement of said first heart valve treatment member, with said fracture edge remaining at said acute angle, towards said second heart valve treatment member which remains expanded at said obtuse angle.
8. The device according to claim 7 , wherein said at least one expandable member of said first heart valve treatment member is lockable in said second expanded shape.
9. The device according to claim 7 , wherein said first heart valve treatment member comprises a cover.
10. The device according to claim 7 , wherein said at least one expandable, non-inflatable member of said first heart valve treatment member comprises at least two arms circumferentially separated from each other about said first shaft, each of said arms having a base coupled to said first shaft and an end opposite said base, wherein in said first expanded shape said ends of each of said arms are radially distanced from said first shaft and said bases remain coupled to said first shaft.
11. The device according to claim 7 , wherein said fracture edge comprises a pulverizing edge.
12. The device according to claim 7 , wherein said fracture edge comprises a breaking edge.
13. The device according to claim 7 , wherein said fracture edge comprises a grinding edge.
14. The device according to claim 7 , wherein said fracture edge comprises a chopping edge.
15. The device according to claim 7 , wherein said fracture edge comprises a cutting edge.