Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2001-06-14
2004-03-30
Reip, David O. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S064000, C606S205000, C600S219000, C600S235000
Reexamination Certificate
active
06712825
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device and method for spreading apart adjacent vertebrae of a vertebral column so that an implant may be inserted therebetween. More particularly, the present invention relates to a distractor device shaped and configured for minimally invasive insertion and use, such as for distraction of vertebrae using an anterior or anterolateral approach.
BACKGROUND OF THE INVENTION
Back pain can be caused by either one or a combination of the following: a loss of disc height, compression of nerve roots, degenerative disc disease, spondylolisthesis, and other causes. The current standard of treatment for people suffering from severe back pain requiring surgical intervention due to different types of pathology is by intervertebral fusion. Intervertebral fusion is achieved by fusing two adjacent vertebral bodies together by removing the affected disc and inserting a suitably sized implant into the disc space that allows for bone to grow between the two vertebral bodies bridging the gap left by the disc removal.
Known intervertebral fusion procedures typically involve the steps of removing a portion or all of the affected disc material, spreading apart adjacent vertebrae with a distractor, and inserting an implant into the space previously occupied by the removed disc material. This procedure can be done either from the front of the patient (anterior interbody fusion) or from the back (posterior interbody fusion). If done from the front, it is important to reduce the size of the distractor so that the procedure is as minimally invasive as possible and thus minimally interferes with and traumatizes the organs and vasculature between the vertebral region being treated and the insertion point. Posterior fusion can utilize larger implants and tools since the insertion space is more accommodating.
Current implants used for interbody fusion include allograft rings/dowels and cages such as threaded cages. However, the technique for the insertion of these implants generally does not achieve distraction because of their height limitations, thus making it difficult to restore the natural disc height. The force necessary to insert these implants (such as by drilling and tapping) may cause damage to the vertebrae or vertebral endplates at the insertion site. Moreover, allograft products and cages made out of other brittle materials (e.g., carbon fiber and ceramics) may break during insertion, particularly when distraction is not used and external force is necessary to insert the implant. Threaded cages on the other hand do not restore lordosis, and do not allow for atraumatic distraction to restore disc height. Thus, there remains a need for improvements in this area.
SUMMARY OF THE INVENTION
In accordance with the principles of the present invention, a spinal disc distractor is provided to allow for an implant insertion technique to be performed during distraction of the disc space. The implants are slid into the disc space between the distractor blades, preferably while the blades are in contact with the upper and lower surfaces of the adjacent vertebral bodies. The distractor of the present invention is formed to be as minimally invasive and atraumatic as possible such that it may readily be used in an anterior or anterolaterial approach. Thus, the distractor of the present invention is configured to be used in the confined spaces of the human anatomy through a small surgical incision and permits the use of laparoscopic approaches like Balloon Assisted Endoscopic Retroperitoneal Gasless (“BERG”).
In a preferred embodiment, the distractor of the present invention has a scissor-like configuration with a pair of handles pivotally connected together. A distractor jaw is coupled to a distal end of each handle such that movement of the handles together draws the jaws apart to separate the vertebrae being treated. In an even more preferred embodiment, the jaws and handles are pivotally coupled together in a double-acting scissor-like configuration to further reduce the space required to move the jaws apart and thus further minimize the invasiveness of the device and procedure.
Although the handles, jaws, and distractor mechanism of the present invention may all lie in the same plane, in order to facilitate visualization of the treatment site during distraction and insertion of an implant, at least the handles may be angled away from the plane of the distractor jaws. In a preferred embodiment, the distractor mechanism is angled downwardly with respect to the jaws and the handles are angled downwardly with respect to the distractor mechanism to further enhance visualization and also to permit greater space for the implant holder adjacent the proximal end of the distractor during insertion of the implant.
A locking mechanism preferably is provided adjacent to or in the handle to maintain distraction. The locking mechanism may include a spindle or threaded bolt mounted on a first handle and passing through the second handle. An internally threaded speed nut is rotatably mounted on the threaded bolt such that movement of the speed nut along the bolt selectively inhibits movement of the second handle away from the first handle and thus maintains the vertebrae at the desired distracted position.
The blades of the distractor of the present invention are configured to increase versatility of the distractor. In a first embodiment of the present invention, the blades are removably coupled to the distractor jaws. Thus, the blades may be changed, as necessary or desired, for a given procedure or patient.
In another embodiment, the blades of the distractor are gradually curved to be out of the plane of the distractor mechanism. Because of the gradual curve, the distal end of the jaws may safely be manipulated through the patient's body with as minimal contact as possible with organs and vasculature including major blood vessels such as the vena cava and aorta. Moreover, such curvature permits insertion through a smaller incision because of the increased manipulability of the gradually curved blades through small openings and spaces.
In yet another embodiment, the blades of the distractor are configured to permit insertion of any type of implant. In particular, although certain implants may be provided with slots for engagement with a surface of the distractor blades during insertion, other implants do not have such slots. The blades of the third embodiment of the present invention are configured and sufficiently spaced apart to permit insertion of either type of implant, regardless of whether slots are provided for engaging distractor blades.
The spinal disc distractor of the present invention is thus designed to distract disc space atraumatically with respect to both the vertebrae and the implant during endplate preparation, implant sizing, and implant insertion. The distractor may be used in a straight anterior, anterolateral, or lateral approach, and may be used in either an open or a laparoscopic procedure. Moreover, the distractor is designed to ensure the selection of an anatomically correct implant size by permitting the annulus to be fully stretched so that the largest possible implant may be inserted and compressed upon release of the vertebrae, thereby enhancing stability and assuring correct placement of the implant. Thus, the present invention permits disc height and lordosis to be restored. The jaws are shaped and configured to preserve the endplate and the vertebral body during distraction, as well as to permit insertion of an implant during distraction. The risk of breakage of allograft implants and other cages made from brittle materials during insertion is thereby reduced.
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patent: 2109147 (1938
Aebi Max
Cottle William A.
Paul David C.
Schenk Beat
Steffen Thomas
Jones Day
Reip David O.
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