Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
1999-10-13
2003-03-18
Smith, Jeffrey A. (Department: 3625)
Surgery
Instruments
Orthopedic instrumentation
Reexamination Certificate
active
06533786
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the field of instrumentation and systems for the spine, and more particularly to instrumentation and systems for use in treatment of various pathologies of the cervical spine.
As with any bony structure, the spine is subject to various pathologies that compromise its load bearing and support capabilities. Such pathologies of the spine include, for example, degenerative diseases, the effects of tumors and, of course, fractures and dislocations attributable to physical trauma. Spinal surgeons have addressed these problems using a wide variety of instrumentation in a broad range of surgical techniques. The use of elongated rigid plates has been helpful in the stabilization and fixation of the lower spine, most particularly in the thoracic and lumbar spine. These same plating techniques have found some level of acceptance by surgeons specializing in the treatment of the cervical spine.
The cervical spine can be approached either anteriorly or posteriorly, depending upon the spinal disorder or pathology to be treated. Many well-known surgical exposure and fusion techniques of the cervical spine are described in the publication entitled
Spinal Instrumentation
, edited by Drs. Howard An and Jerome Cotler. This text also describes instrumentation that has been developed in recent years for the cervical spine. Plating systems have become predominant for providing internal instrumentation in techniques that achieve fusion of the cervical spinal from an anterior approach.
During the development of cervical plating systems, particularly for the anterior approach, various needs have been recognized. For example, the system should provide strong mechanical fixation that can control movement of each vertebral segment. The system should be able to withstand axial loading and continuity with each of the three columns of the spine. The system should also be able to maintain stress levels below the endurance limits of the plate material, while at the same time exceeding the strength of the anatomic structures or vertebrae to which the plating system is engaged. The thickness of the system should be small to lower its prominence, particularly at the smaller spaces of the cervical spine. Also, the screws used to connect the plate to the vertebrae must not loosen over time or back out from the plate.
While the plating system should satisfy certain mechanical requirements, the system should also satisfy certain anatomic and surgical considerations. For example, the cervical plating system should minimize the intrusion into the patient and reduce the trauma to the surrounding soft tissue. This is particularly important in such procedures that relate to the cervical spine because the complications can be very devastating, such as injury to the brain stem, spinal cord, or vertebral arteries. It has also been found that the optimum plating system permits placement of more than one screw in each of the instrumented vertebrae. Also, the system should be designed to contact the vertebrae for greater stability.
Many spinal plating systems have been developed in the last couple of decades to address some of the needs and requirements for cervical fixation systems. However, even with the more refined plating system designs, there still remains a need for a system that effectively addresses the requirements for such a system.
There is also a need for a plating system that addresses procedures designed to achieve fusion of the cervical spine. In cases where a graft or implant is implanted to maintain a disc space and/or replace one or more diseased vertebral bodies, it is desirable to increase the rate of fusion and incorporation of the graft or implant into the spine. A plating system that allows pre-loading of the graft or implant and/or provides continual loading thereafter is preferred.
While the prior art plating systems relating to cervical plating systems are steps in the right direction, there remains a need for additional improvements. The present invention is directed to satisfying these needs, among others.
SUMMARY OF THE INVENTION
The present invention contemplates a system for anterior fixation of the spine that utilizes an elongated fixation plate. In one aspect of the invention, the plating system promotes fusion and incorporation of a graft or implant in a spinal column portion. The plating system provides continual loading of the graft or interbody implant. In another aspect, the plating system allows a compressive load to be applied to the spinal column portion. This pre-loading and continual loading avoids stress-shielding and promotes fusion and incorporation of the graft or implant into the spinal column portion.
In one aspect of the invention, the fixation plate has a first end with a pair of holes. Bone engaging fasteners extend through the holes to rigidly secure the plate to a first vertebra. A second end of the plate is provided with a pair of slots through which bone engaging fasteners extend for engagement with a second vertebra. The bone engaging fasteners extending through the slots are translatable in the slots to allow settlement and compression of the second vertebra with respect to the first vertebra. In a preferred embodiment, the plating system includes a retainer assembly that prevents fastener back out.
According to another aspect of the invention, a bone fixation system for a spinal column segment is provided. The bone fixation system includes a plate with a central axis, a length between a first end and a second end, and top and bottom surfaces. The plate defines a plurality of first openings and a plurality of second openings between the top and bottom surfaces. At least one of the plurality of first openings is positioned adjacent the first end of the plate and defines a circular hole though the plate. At least one of the plurality of second openings is positioned adjacent the second end of the plate and defines a slotted hole having a first width and a first length adjacent the bottom surface. A number of bone engaging fasteners extend through the first and second openings. Each bone engaging fastener has a threaded shank and an enlarged head. The fastener has a substantially cylindrical portion with a third diameter that interfaces with the plate in the first opening such that the fastener inserted in the first opening assumes a fixed orientation with the plate. The head of said bone engaging fastener inserted into the second opening is translatable along the length of the second opening to maintain compression of the spinal column portion.
In another aspect of the invention, a bone fixation system for a spinal column portion is provided. The bone fixation system includes a plate with a length along a central axis that extends between a first end and a second end. The plate has a top surface and a bottom surface and defines a plurality of first and second openings between the surfaces. At least a pair of the first openings is positioned adjacent the first end, and the first openings define a circular opening having a first diameter. At least a pair of the second openings is positioned adjacent the second end, and the second openings define a slot having a first width and a first length. A number of bone engaging fasteners with an elongated threaded shank and an enlarged head are provided. The bone engaging fasteners extend through the first and second holes from the top surface. A retainer assembly retains the bone engaging fasteners in the first and second openings. In one form, the retainer assembly includes a washer having a length that substantially corresponds to the length of the plate.
In yet another aspect of the invention, a bone fixation system for a spinal column segment is provided. The system includes four bone engaging fasteners that have an enlarged head and a threaded shank. An elongated plate has a length extending between a first end and a second end sized to span between at least two vertebrae. The plate defines one pair of holes adjacent the first end and one pair of slots adj
Herkowitz Harry N.
Needham Dusty Anna
Poyner Jeffrey Wade
Zdeblick Thomas A.
SDGI Holdings Inc.
Smith Jeffrey A.
Sterne Kessler Goldstein & Fox P.L.L.C.
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