The present invention relates to a plate system or assembly, in conjunction with pedicle or bone screws, for aligning and maintaining adjacent cervical vertebrae in a desired spinal relationship during spinal fusion of the vertebrae.
Current practice in the art of cervical spinal fusion is to secure a cervical plate along two or more vertebral bodies through the use of bone screws which extend through screw holes formed in the plate. The fixation plate, as installed, serves to immobilize the vertebral bodies. This immobilization when employed with bone graft promotes the occurrence of fusion between the adjacent vertebral bodies. The goal of this procedure is to restore an appropriate disc height between the bodies and reduce the patient's pain.
Several challenges exist in the use of cervical spinal fusion plates. One, the screws employed to secure the plate to the underlying bone have a tendency to accidentally back out of the plate over time due to motion of the underlying bone segments. This backing out phenomenon will result in instability of the joint and pain for the patient. In addition, such backing out, may cause the screws and/or plate to come into unwanted contact with soft tissue and the esophagus.
Two, there are occasions when the surgeon needs to be able to reset one or more of the screws into a different location in the underlying bone or replace the plate. Thus, any back out prevention arrangement between the screws and the plate must allow the screws to be purposely backed out.
Three, since cervical fixation plates are necessarily surrounded by soft tissue and located in close proximity to the esophagus it is highly desirable for the plates to have a low profile, i.e., have a minimum thickness, while meeting the strength requirements. It is also preferable to keep the plates as narrow as possible to reduce the chances that the lateral edges of the plate will rise off of the underlying vertebral body and cause pain/dysphagia where the curvature of the plate does not exactly match the patient's anatomy.
The back out problem has been addressed in a variety of ways. See Cordaro, U.S. Pat. No. 7,220,263 which discloses a screw and cervical plate design in which the entry section of the screw hole includes a partial thread followed by a larger diameter neck section so that the screw head, once advanced into the neck section, can rotate freely to allow the plate to be pulled tightly against the underlying bone during surgery. Once installed, the threaded entry section prevents the screw from being pushed out by motion of the underlying bone, but permits the screw to be rotated out of the screw hole. While this design prevents a common screw back out problem, i.e., the screw being pushed out, it does not eliminate the possibility that movement of the underlying bone will cause the screw to rotate in a counterclockwise direction and in this manner back out of the plate.
Also see Michelson, U.S. Pat. No. 6,936,050, to which discloses the use of locking screws or removable rivets which overlay the heads of installed pedicle screws. This type of locking arrangement does not readily lend itself to a low profile contoured surface suitable for deployment on the anterior aspect of the spine. In addition, the locking screws add complexity to the system and are not particularly surgeon friendly. Also, see Koo, U.S. Patent Publication No. 2005/0021032 which teaches the use of a plate screwed over the heads of the installed screws by rivets.
Binder, publication U.S. 2005/0234455, teaches the use of an interference fit between the pedicle screw heads and the plate screw holes to prevent screw back out on the premise that the normal torsional and bending motion of the body and spine will not cause the screws to overcome the friction resulting from the interference fit. As a precautionary matter, the inventor advises the use of set screws. Without the additional set screws the system does not appear to be fail safe from a back out standpoint and with the addition of the screw screws has the same shortcomings as the Michelson system. In addition, it is customary for the fixation plates to allow the bone screws to assume different angles relative to the longitudinal axis of the screw holes, i.e., swivel relative to the plate to allow the surgeon to penetrate the vertebral bodies at an optimum angle. The Binder system would not seem to accommodate such angulation.
Several prior art patents teach the use of slidable plates which are arranged to extend over the tops of the installed pedicle screws. See Richelsoph et al, U.S. Pat. No. 6,695,846; Paul, U.S. Pat. No. 7,008,426; Lin, U.S. Patent Publication No. 2005/0261689; Baynham, U.S. Publication No. 2005/0177161; Paul et al, U.S. Pat. No. 6,755,833 and Assaker et al, U.S. Pat. No. 6,652,525.
Several prior art approaches involve the use of a spring member such as an elongated retainer inserted over the installed screw heads and held in place by recess located below the anterior surface of the plate. See Ferree, U.S. Pat. No. 7,025,769. Other approaches involve the use of split elastically deformable rings carried by a recess in the screw head or in the plate surrounding the screw hole. See Fallin et al, U.S. Pat. No. 7,309,340 (“340 patent”); Mosca et al, U.S. Publication No. 2005/0192577; Lindemann et al, U.S. Publication No. 2005/0283152; Blain, U.S. Publication No. 2006/0235412; and Campbell et al, U.S. Pat. No. 6,602,255 (“'255 patent”).
The '340 patent discloses an anti-backout cervical plate/screw system in which a split ring is carried in a recess in the head of the screw and expends out to rest beneath an undercut in the plate surrounding the screw hole when installed. The plate has access channels spaced around the screw hole through which the prongs of a removal tool can be inserted to compress the split ring so that the screw can be removed. A similar anti-backout arrangement is used in a prior art plate/screw system marketed by the assignee of this application, SeaSpine, Inc., under the brand name Sonoma Plate.
Cervical plate systems with an anti-backout feature which relies on an undercut around all or most of the screw holes, as in the '340 and Sonoma Plate systems, compromise the low profile criteria by requiring a greater thickness in the region of the undercut. The split ring arrangement of the '255 patent undercuts and thus compromises the medial area between the crew holes. Such area is critical to the overall strength of the plate. In addition, the locking mechanism of the '255 patent reduces the effective area of the graft window and compromises the ability of the surgeon to visually verify correct graft placement and compression.
There is a need for an improved fixation plate assembly or system which more closely meets the challenges discussed above.
A spinal fixation plate assembly in accordance with the present invention includes a fixation plate having an anterior surface, a posterior surface and at least one pair of spaced screw holes extending through the surfaces along substantially parallel axii bisected by a central perpendicular plane. Each screw hole has a generally cylindrical wall to allow the threaded shaft of a bone screw to pass therethrough, but not the enlarged head. The screw hole wall accommodates the head of the screw with a latch engaging surface of the screw head (which may be the top of the head) located below a lateral plane generally perpendicular to the associated longitudinal axis.
A v-shaped latch member or latch having a central head portion joined to a pair of wings through elastically deformable arms is carried by the plate, for example, in a recess or cavity. The latch is moveable between a deployed and a retracted position. In its deployed position the wings extend into the screw holes above the lateral plane to substantially prevent a screw positioned in the hole from backing out. In its retracted position the wings are retracted from the screw holes to allow the screw to be removed.
The application of a force to the latch head in a direction away from the screw holes serves to move the latch from its deployed to its retracted position.
Preferably the latch head is formed with a tool engaging surface and the plate is formed with a tool access opening through which a tool may be inserted to apply force to the tool engaging surface of the latch head. Alternatively, a tool may be inserted into the screw hole on top of the screw head to push a latch wing out of the way.
Additional features of the invention are discussed in the preferred embodiment section, the claims and shown in the drawings. The construction of the spinal fixation plate assembly of the present invention and the various features thereof may best be understood in reference to the following description taken in conjunction with the appended drawings.
a, 10b, 10c and 10d are enlarged cross-sectional views taken along lines 10-10 with the head of the screw positioned slightly above the latch wind (10a) engaging the latch wing to retract the same (10b, 10c) and fully inserted into the hole with the latch wing overlying the latch engaging surface of the screw head (10d);
a and 12b are top plan views of a modified six hole spinal fixation plate, respectively, with
a is an enlarged view of the plate portion of
b is a cross-sectional view of the plate portion taken along lines 15b;
a and 16b are plan views of a latch in its natural and compressed state (for insertion into the plate cavity) respectively;
a and 17b are plan views of the upper end of the plate showing a latch ready for insertion into the cavity (
a and 18b are cross-sectional views of the plate of
Referring now to the drawings, and particularly to
Reference is now directed to one of the screw holes 20, as shown in the cross-sectional view of
The plate is formed with a pair of planar latch supporting depressions or recesses 26 with stepped inner and outer walls 26a and 26b, respectively (
Each of the walls 26a and 26b extends upwardly from a floor 26e along a lower and upper portions 26f and 26g, respectively, to form an intermediate shelf 26h (
Referring again to
Referring now to
The lower outer wall 26g terminates in a corner 26i against which the inner corner 30f of the latch wing abuts in its natural state as is illustrated in
A simple latch retracting tool 34 is shown above the plate 10 in
The progression of the screw head into the screw hole pushing the latch wing tip 30f into its retracted position is illustrated in
The plate 10″ is formed with a depressed planar recesses 40 supporting the latch 30″. As is illustrated, each of the recesses 40 extend from a bone graft window 24″ to intersect an associated pair of screw holes 20″ along the same arc discussed with respect to the embodiment of
The plate 10″ is machined to form an undercut resulting in an overhang 42 represented by the area between the dashed and solid lines in
To install the latch 30″ into the cavity 41, the latch 30″ may be placed on the depressed recess 40 and then compressed and forced into the cavity so that the wings extend into the screw holes as shown in
There has thus been described an improved spinal/cervical fixation plate assembly which meets the challenges discussed previously. Further modifications or perhaps improvements of the plate assembly will occur to those skilled in the art without involving a departure from the spirit and scope of the invention as defined in the claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2008/007074 | 6/5/2008 | WO | 00 | 12/2/2010 |