Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
1999-08-13
2001-05-01
Buiz, Michael (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S060000
Reexamination Certificate
active
06224597
ABSTRACT:
BACKGROUND OF THE INVENTION
There are five bones in the human skeleton called vertebral bodies that comprise the structure of the lumbar spine. These bones are normally in a structure which allows them to be stacked on top of one another much like building blocks. In this relationship, and through their interlocking structure, the spine can bend forward, called flexion, or bend backwards, called extension. It can bend to either side, called lateral bending, and it can also twist or rotate. These ranges of motion are facilitated by muscles which attach to the lumbar vertebrae and these motions are stabilized not only by the bones themselves but by ligaments and discs which attach to these vertebrae.
In the course of human development, human deterioration and various disease processes and trauma, the alignment of the spine can be altered in such a way that one or more bones might become loose on one another causing an instability problem. The medical term for this problem is spondylolisthesis. The vertebral bodies also might develop a curvature problem called scoliosis. The development of arthritic spurs may also distort spinal configuration. Fractures, tumors, infections, and extensive surgical procedures can also distort spinal anatomy and spinal integrity resulting in the development of deformities of the lumbar spine.
In the last 30 years, a great deal of work has been done in orthopaedics on the development of procedures to stabilize deformity in the lumbar spine, and more recently to correct that deformity. The reason to correct the deformity is that the lumbar spine serves in many ways as a foundation on which the remaining structure of the thoracic and cervical spine exists. Having the lumbar spine in a more appropriate position allows for more normal functioning of the spinal structure above it.
Surgery is sometimes required to realign the spine. Generally, the surgeon will cut into the back of the patient to access the spine. He will use a retractor to hold skin and muscle away from the spine to improve his access to the spine. To align a lumbar vertebra, a screw called a pedicle screw will be inserted into the pedicle portion of a lumbar vertebra. Then the surgeon will pull on the pedicle screw to move the lumbar vertebra into appropriate alignment. Usually, internal hardware will then be attached to the spine to maintain proper alignment. To avoid trauma to the muscles, ligaments and nerves attached to the spinal cord, it is very important that the vertebra not be yanked into alignment. However, accomplishing this objective is easier said than done. Occasionally, with the pressure that is required to “pull” the vertebra into alignment, when the resistance to realignment is overcome, the surgeon cannot react quickly enough to prevent the vertebra from being yanked. In fact, gradual, even pressure on the vertebra is difficult to accomplish, thus making the surgery one of greater risk to complication than is desirable.
What is needed is a device to allow the surgeon access the pedicle screw from various angles and a platform and device which will enable the surgeon to apply even pressure on the vertebra as it is pulled into alignment without “yanking” the vertebra into place.
The device should be one which can be manipulated through multiple degrees of freedom to align with the pedicle screw is needed.
The device must enable the surgeon to apply a steady, gently, increasing tension to the pedicle screw during the alignment process.
The device should allow the surgeon to concentrate on the delicacies of the procedure, rather than muscling a vertebra into position.
The device should allow the surgeon to make minute adjustments to vertebra during spinal surgery to reduce the risk of back surgery to a patient.
Such a device would preferably maintain spinal alignment while the surgeon attaches in-dwelling hardware.
A device satisfying these needs is believed to be lacking in the prior art.
SUMMARY OF THE INVENTION
The invention relates to equipment used in conjunction with surgery and more specifically to a device for use in conjunction with back, or spine, surgery. The device enables the surgeon to make minute vertebral adjustments. This invention is an alignment facilitator which aids the orthopedic surgeon in realigning the vertebrae of the spine; it enables the surgeon to make minute vertebral adjustments during the course of spinal surgery and greatly reduces the risk associated with such a procedure.
During a lumbar vertebrae alignment procedure, the surgeon will attach a pedicle screw to the pedicle portion of lumbar vertebrae and gently pull vertebrae into alignment by applying tension to the pedicle screw. This invention includes a tensioning device adapted to attach to the pedicle screw and apply tension to the pedicle screw. It also includes a support device adapted to support the tensioning device over the patient. The support system includes an alignment system so that the surgeon can align the tensioning device with the pedicle screw. Alternatively, the support device may include a tracking and pivoting system which includes means for supporting and aligning the tensioning device.
The tracking and pivoting system will allow the surgeon to place the tensioning device in proper alignment with the pedicle screw. The support device will generally include a forward support and a rearward support for supporting the tracking and pivoting system.
The orientation and directions used in this application are relative to a patient lying face down. A forward location is closer to the head of the patient than a rearward location. Longitudinal and lateral directions are along the body of the patient, and across the body (from side to side), respectively. These directions and orientation would change as appropriate when the invention is used in other orientations. Other positions and orientations would allow the invention to be used to align other vertebrae or bones.
The rearward support, in one embodiment, includes a sacral bridge which is adapted to sit on iliac spines, or iliac crests of the patient. This is because the hip bones generally provide a solid stable surface which would not be traumatized by the, albeit relatively minimum, weight or pressure produced when tension is applied to the pedicle screw. The forward support, generally, includes a support rod. The support rod would be adapted to fit on a stable and strong surface, such as a retractor, or the scapula portion of the back, or similar surface.
The support device includes an adjustment rod slidably connected to the sacral bridge and slidably connected to the support rod so that the adjustment rod can move laterally above the patient. The adjustment rod may be movably connected to the support rod, so that the adjustment rod can move longitudinally relative to the support rod. Alternatively, or in combination, the support rod may be movably connected to the retractor so that the adjustment rod can move relative to the retractor.
The support device also includes a gurney for supporting and aligning the tensioning device. The gurney engages the adjustment rod so that the tensioning device may move longitudinally and may pivot about an axis parallel to the adjustment rod. In one embodiment, the gurney includes bearing connections at the forward and rearward supports so that the adjustment rod may pivot. Thus, the adjustment rod can move via the gurney, and the tensioning device may, but need not, be fixedly attached to the adjustment rod. Alternatively, the gurney can move via the adjustment rod.
Alternatively, the gurney includes a longitudinal pivotal connector engaging the adjustment rod so that the gurney may pivot or rotate about an axis parallel to the adjustment rod. In one embodiment the gurney pivots about the adjustment rod. In one embodiment, the tensioning device is movably attached to the gurney.
The gurney, in one embodiment, includes a slidable connector engaging the adjustment rod so that the gurney may move longitudinally along the adjustment rod. The slidable connector engaging the adjustment rod
Buiz Michael
King Anthony S.
Waddey & Patterson
Waddey, Jr. I. C.
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