Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
1997-06-09
2001-06-19
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S092000, C606S192000
Reexamination Certificate
active
06248110
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the treatment of bone conditions in humans and other animals.
BACKGROUND OF THE INVENTION
When cancellous bone becomes diseased, for example, because of osteoporosis, avascular necrosis, or cancer, the surrounding cortical bone becomes more prone to compression fracture or collapse. This is because the cancellous bone no longer provides interior support for the surrounding cortical bone.
There are 2 million fractures each year in the United States, of which about 1.3 million are caused by osteoporosis alone. There are also other bone disease involving infected bone, poorly healing bone, or bone fractured by severe trauma. These conditions, if not successfully treated, can result in deformities, chronic complications, and an overall adverse impact upon the quality of life.
U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose apparatus and methods for the fixation of fractures or other conditions of human and other animal bone systems, both osteoporotic and non-osteoporotic. The apparatus and methods employ an expandable body to compress cancellous bone and provide an interior cavity. The cavity receives a filling material, which hardens and provides renewed interior structural support for cortical bone.
The better and more efficacious treatment of bone disease that these Patents promise can be more fully realized with improved systems and methods for making and deploying expandable bodies in bone.
SUMMARY OF THE INVENTION
The invention provides improved systems and methods for treating bone, including vertebral bodies, as well as in other bone types, using one or more expandable bodies.
One aspect of the invention provides systems and methods for treating bone using an expandable wall in association with a nozzle for discharging a material. According to this aspect of the invention, the systems and methods insert both the body and the nozzle into a bone having cortical bone surrounding an interior volume occupied, at least in part, by cancellous bone. The systems and methods causing the body to assume an expanded geometry while occupying the interior volume in the presence of the nozzle to compact cancellous bone and form a cavity in the interior volume. The systems and methods convey a material for discharge through the nozzle into the cavity at least partially while the body occupies the interior volume.
In a preferred embodiment, the systems and methods convey bone cement for discharge through the nozzle, while the body is in the expanded geometry or a partially expanded geometry. The systems and methods can also cause the expanded geometry of the body to decrease in volume in relation to volume of material discharged by the nozzle into the cavity.
In one embodiment, the expandable body and nozzle are deployed separately into the targeted bone. In a preferred embodiment, the expandable body and nozzle form a integrated tool and are deployed simultaneously into the targeted bone.
Another aspect of the invention provides systems and methods for treating bone using first and second expandable bodies. The first expandable body is inserted into the interior bone volume through a first access path in cortical bone. The second expandable body is inserted into the same interior bone volume through a second access path in cortical bone different than the first access path. The systems and methods cause each of the bodies to assume an expanded geometry for jointly compacting cancellous bone to form a cavity in the interior volume.
In one embodiment, the first and second access paths comprise different ipsilateral posterolateral accesses. In another embodiment, the first and second access paths comprise different transpedicular accesses. In yet another embodiment, the first a second access paths comprise a transpedicular access and a postereolateral access.
Another aspect of the invention provides a body for insertion into a bone, which comprises two expandable zones. The first zone assumes an elongated expanded geometry. The elongated geometry presents a first dimension, which extends substantially across the interior volume, to form a barrier within the interior volume. The elongated geometry also presents a second dimension less than the first dimension, which leaves a region of substantially uncompacted cancellous bone extending from the barrier within the interior volume. The second expandable zone assumes a different expanded geometry, which compacts cancellous bone to form a cavity in the region. The barrier formed by the first zone directs expansion of the second zone in the region away from the first zone.
In one embodiment, the first and second expandable zones comprise separate expandable assemblies. In another embodiment, the first and second expandable zone comprise parts of a single expandable assembly.
Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended Claims.
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Reiley Mark A
Scholten Arie
Scribner Robert M
Talmadge Karen D
Kyphon Inc.
Recla Henry J.
Ryan Kromholz & Manion S.C.
Woo Julian W.
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