Method for treating a vertebral body
View Patent ↗A structure adapted to assume an expanded geometry having a desired configuration when used in bone includes material that limits the expanded geometry. The structure undergoes stress when expanded during its first use in bone. As a result, the structure can not be relied upon to reach its desired configuration during subsequent use in bone. Accordingly, the structure is packaged in a sterile kit, which verifies to the physician or user that the device packaged within it is sterile and has not be subjected to prior use. The physician or user is thereby assured that the expandable structure meets established performance and sterility specifications, and will have the desired configuration when expanded for use.
1. A method comprising
selecting a vertebral body for treatment having a cortical wall enclosing a cancellous bone volume,
providing a void creation device including an expandable structure adapted to undergo expansion in the cancellous bone volume, the expandable structure having at least one dimension so that the expandable structure will assume a predetermined shape and size when substantially expanded that compacts only a first volume of the cancellous bone volume to form a void, leaving a second volume of the cancellous bone volume substantially uncompacted by the expandable structure,
introducing the void creation device into the vertebral body through a percutaneous access path,
expanding the expandable structure in the cancellous bone volume to the predetermined shape and size to create the void,
leaving the second volume of the cancellous bone volume substantially uncompacted by the expandable structure, and
placing a filling material within the void through the percutaneous access path.
2. A method according to claim 1 ,
wherein the first volume of the cancellous bone volume comprises about 30% to 90% of the cancellous bone volume.
3. A method according to claim 1 wherein the first volume of the cancellous bone volume comprises about 40% to 90% of the cancellous bone volume.
4. A method according to claim 1 wherein the structure comprises an inflatable body.
5. A method according to claim 1 wherein the structure comprises a balloon.
6. A method according to claim 1 wherein the filling material placed within the void hardens within the void.
7. A method according to claim 1 , further including removing the structure from the void.