VERTEBRAL FIXATION PLATE SYSTEM AND METHOD FOR USE
20170224389 · 2017-08-10
Assignee
Inventors
Cpc classification
A61F2002/30578
HUMAN NECESSITIES
A61F2002/30367
HUMAN NECESSITIES
A61F2002/30331
HUMAN NECESSITIES
A61B2576/00
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
A61F2002/30433
HUMAN NECESSITIES
A61F2002/30494
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2002/3054
HUMAN NECESSITIES
A61F2002/30553
HUMAN NECESSITIES
A61F2002/30354
HUMAN NECESSITIES
International classification
Abstract
A vertebral fixation plate system and a method for its use in a surgical procedure to fuse adjacent spinal vertebrae. A mounting member is attached to the vertebral fixation plate so that the fixation plate can move with respect to the mounting member through a range of available positions. The mounting member can be attached to a spinal interbody fusion device installed in place of a removed spinal disc, thus also loosely fastening the vertebral fixation plate to the fusion device. A fastener can tighten the vertebral fixation plate to the mounting member and establish a location of the vertebral fixation plate with respect to the vertebrae to be fused. Confronting surfaces of the mounting member and the vertebral fixation plate cooperate to keep the vertebral fixation plate in a desired location while it is fastened to the vertebrae being fused.
Claims
1. A vertebral fixation plate system for use with an interbody fusion device having a front face, the system comprising: (a) a vertebral fixation plate having a principal plane, an inner face, an outer face, and a thickness and defining a plurality of primary fixation fastener receptacles each located in a respective position to receive a respective fastener extending therethrough into one of a pair of adjacent vertebrae to be held in a fixed positional relationship to each other, the vertebral fixation plate also defining a mounting member receptacle in the inner face; (b) a mounting member, the mounting member having a main body located within the mounting member receptacle, an inner face, and an outer end, and defining a bore extending through the main body from the inner face to the outer end; (c) the mounting member receptacle having a ceiling and a depth and receiving the mounting member, and having dimensions, in respective directions generally parallel with the principal plane of the vertebral fixation plate, at least great enough so that the mounting member is free to move within the mounting member receptacle, through at least a predetermined distance generally parallel with the principal plane of the vertebral fixation plate; (d) the vertebral fixation plate defining an opening extending through the vertebral fixation plate into the mounting member receptacle and located so as to receive the mounting member; and (e) the outer face of the main body of the mounting member and the ceiling of the mounting member receptacle having respective surface configurations that are capable of engaging each other, with the vertebral fixation plate in a selected one of a plurality of positions relative to the mounting member, so as to resist movement of the vertebral fixation plate relative to the mounting member.
2. The system of claim 1 wherein the vertebral fixation plate defines a recessed portion communicating with the outer face and having a planar bottom surface surrounding the opening extending through the vertebral fixation plate.
3. The system of claim 2 further including a fastener having a shaft portion slender enough to extend freely through the bore defined by the mounting member and long enough to extend further into a fastener receptacle in a front face of the interbody fusion device, the fastener having a retaining flange extending radially outward from the shaft portion, the retaining flange being in contact with the outer end of the mounting member when the shaft portion extends into the fastener receptacle.
4. The system of claim 1 further including a fastener having a shaft portion slender enough to extend freely through the bore defined by the mounting member and to extend matingly into a fastener receptacle in a front face of an interbody fusion device, the fastener having a retaining flange extending radially outward from the shaft and in contact against the outer end of the mounting member when the shaft portion extends into the fastener receptacle.
5. The system of claim 1 wherein the surface configuration of the inner face of the mounting member includes a plurality of projecting ridges and wherein the ceiling of the mounting member receptacle defines a plurality of closely-spaced small grooves adapted to receive the projecting ridges and resist movement of the vertebral fixation plate relative to the mounting member when the vertebral fixation plate is in a desired location and orientation relative to the mounting member.
6. The system of claim 1 wherein the vertebral fixation plates are connected with each other but movable with respect to each other;
7. A method of implanting a vertebral fixation plate as part of a procedure for fusing a pair of mutually adjacent vertebrae to each other, comprising: a. creating an incision and gaining access to a portion of a person's spinal column; b. retracting soft tissue and thereby exposing an aspect of a pair of vertebrae to be fused; c. removing at least a portion of an intervertebral disc from between the vertebrae to be fused and placing an interbody fusion device between the vertebrae; d. providing a vertebral fixation plate having an outer face and an inner face, a mounting member receptacle being defined in the inner face thereof and the vertebral fixation plate having a mounting member retained partially within the mounting member receptacle and movable therein with respect to the vertebral fixation plate; e. placing the vertebral fixation plate adjacent a face of the interbody fusion device with an outer face of the mounting member facing toward the interbody fusion device; f. providing a fastener having a shaft portion and a flange extending radially from the shaft portion; g. placing the fastener with respect to the vertebral fixation plate and the interbody fusion device so that the shaft portion extends through an opening defined by the vertebral fixation plate and through a bore defined in the mounting member and into a fastener receptacle defined in the interbody fusion device, thereby attaching the mounting member to the interbody fusion device; h. placing the vertebral fixation plate in a selected location with respect to the mounting member, thereby placing the vertebral fixation plate into a position bridging a space between the vertebrae to be fused, while the mounting member remains within the mounting member receptacle; i. moving a retainer along the shaft portion of the fastener, thereby urging the vertebral fixation plate into immobilizing contact with the mounting member with the vertebral fixation plate in the selected location with respect to the mounting member; and j. thereafter, fastening the fixation plate to both of the vertebrae to be fused, thereby immobilizing the vertebrae with respect to each other.
8. The method of claim 7 including using the fastener to fasten the mounting member to the interbody fusion device tightly while the vertebral fixation plate remains movable with respect to the mounting member, thereafter placing the vertebral fixation plate into the position bridging the space between the vertebrae to be fused and then fastening the vertebral fixation plate to the mounting member while keeping the vertebral fixation plate stationary with respect to the mounting member.
9. The method of claim 8 including radiographically observing the position of the vertebral fixation plate with respect to the vertebrae to be fused after fastening the vertebral fixation plate into the selected location with respect to the mounting member and before fastening the fixation plate to the vertebrae to be fused, and thereafter loosening the vertebral fixation plate with respect to the mounting member and moving the vertebral fixation plate to an adjusted position, thereafter tightening the retainer, and thereafter fastening the vertebral fixation plate to the vertebrae.
10. The method of claim 8 including observing the position of the vertebral fixation plate with respect to the vertebrae to be fused, after attaching the mounting member and the vertebral fixation plate to the interbody fusion device and before fastening the vertebral fixation plate to the vertebrae to be fused, and thereafter moving the vertebral fixation plate with respect to the mounting member to an adjusted position, and thereafter fastening the fixation plate to both of the vertebrae to be fused while the vertebral fixation plate remains in the adjusted position.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0048] Referring now to the drawings that form part of the disclosure herein, in
[0049] Each of the receptacles 38 may be bowl-shaped, or approximately hemispherical, and the respective hole 40 associated with each receptacle 38 may be larger than the shaft of the screw 36 extending through the hole, so that the screw 36 may be oriented either perpendicular to the fixation plate 26 or at an angle a within a range of a few degrees from being perpendicular to the fixation plate 26. This can simplify installation of the screws 36 and allow each of the screws to be placed into a vertebra at a selected angle α intended to provide a secure attachment of the plate 26 to the vertebra concerned and to provide improved security by virtue of the screws 36 not being parallel with each other.
[0050] As with conventional vertebral fixation plates, the screws 36 used may be of any one of several different types, including screws for which bores must be tapped after being made, self-tapping screws, or self-drilling screws, at the election of the surgeon carrying out the spinal fusion procedure utilizing the vertebral fixation plate system 24 disclosed herein.
[0051] The vertebral fixation plate 26 bridges the space 42 from which the natural intervertebral disc has been removed from between the pair of adjacent vertebrae 20, 22 and where an interbody fusion device 44, hereinafter also called an intervertebral graft body, has been installed. In
[0052] As shown in
[0053] An outer face 64 of the base member 52 may be provided with locators 66 in the form of small raised ridges as shown in
[0054] As may be seen from an opposite viewpoint in
[0055] The outer face 64 of the base member, as shown in
[0056] A group of small locating cavities 70 with shapes and sizes corresponding to those of the locators 66, 66′, etc. on a base member 52 are provided, closely spaced in the bottom, or ceiling, surface 68 of the receptacle 58 in the inner side 59 of a mating vertebral fixation plate. Appropriately located ones of the locating cavities 70 can receive the locators 66 with the vertebral fixation plate 26 in any of several slightly different available positions relative to the base member 52 with the base member 52 seated in the receptacle 58 in the inner side 59 of the vertebral fixation plate 26.
[0057] For example, as shown in
[0058] Referring now to
[0059] While a suitable base member 52, made to mate with a particular vertebral fixation plate 26 or 26′, etc., may be fastened to a conventional interbody fusion device or graft body 44, a shown in
[0060] In order to quickly establish an optimum location for the vertebral fixation plate of the fixation plate system disclosed herein, a surgeon will make an incision leading to the patient's spine and will retract intervening tissue to gain access to the spine at the level where a disc is to be removed and the adjacent vertebrae are to be fused. The defective disc is removed and a graft body 44 is installed in its place. If the graft body is a conventional interbody fusion device as shown in
[0061] With the base member 52 exposed and overlapping, or at least not hidden between, the adjacent vertebrae 20, 22, the vertebral fixation plate 26 is placed atop the base member 52 or 87, so that the base member 52 extends into the recessed receptacle 58 in the inner side 59 of the vertebral fixation plate 26. The surgeon estimates the correct position for the vertebral fixation plate 26 and places the fixation plate against the vertebrae 20, 22 so that the base member 52 or 87 is received in the receptacle 58. Optionally, the surgeon may use a tool such as the tool shown 48 in
[0062] A radiographic image can then be obtained to determine whether the vertebral fixation plate 26 is in the desired location with respect to the vertebrae 20, 22 to which it is to be fastened. If an image suggests that a revised position is necessary, adjustment can be made in defined small steps in the desired direction, either angularly or in translation, depending upon the version of the fixation plate 26 and corresponding base member 52 being used. With marks 86 provided on the outer face 64 of the base member 87 and an arrow 84 on the outer face 82 of the vertebral fixation plate 26, as shown in
[0063] The vertebral fixation plate 26 can then be held in that position, mated against the base member 52, by simple pressure, either using the tool 48 or by manual pressure exerted by the surgeon while the screws 36 are inserted into the receptacles 38 and through the associated holes 40 to fasten the vertebral fixation plate 26 to the vertebrae 20, 22 in a minimum amount of time. It may be most efficient to place a screw 36 into the vertebrae at each of a pair of diagonally opposite corners of the fixation plate 26 initially.
[0064] The definite retention of the vertebral fixation plate 26 in the chosen position, as a result of the mating of the locators 66 in the locator cavities 70 within the receptacle 58 defined in the inner side 59 of the vertebral fixation plate 26, gives the assurance that the vertebral fixation plate 26 will be located properly with respect to the space 42 between the vertebrae 20, 22 and as to alignment with the portion of the spine where vertebral fusion is to take place.
[0065] While the vertebral fixation plate system 24 disclosed above has addressed a single-level spinal fusion procedure, the system can similarly be used for fusion at one or more adjacent additional levels by utilizing a similar but longer vertebral fixation plate, long enough to extend to where it can be fastened to each of the involved vertebrae and including a recessed receptacle 58 to be mated with a base member 52 attached to a graft body 44 or incorporated in a graft body 90 implanted in the intervertebral space 42 at one of the levels where fusion is to take place.
[0066] Referring now to
[0067] A vertebral fixation plate 126 has a pair of opposite ends 128, 130, respectively facing in cephalad and caudal directions, and a pair of opposite lateral sides 132, 134. Fasteners such as screws 36 are mounted in respective receptacles 138 in the corners of the fixation plate 126, from which the fasteners extend through respective holes 140 in the fixation plate 126 into each of the vertebrae 20 and 22, as may be seen in
[0068] Each of the receptacles 138 may be bowl-shaped, or approximately hemispherical, and the respective hole 140 associated with each receptacle 138 and extending through the fixation plate 126 may be larger than the shaft of the screw 36 extending through the hole, so that the screw 36 may be oriented either perpendicular to the fixation plate 26 or at an angle a within a range of a few degrees from being perpendicular to the fixation plate 26, as seen in
[0069] As seen best in
[0070] In
[0071] A fastener 164, which may be a specially designed screw, has a shaft 166 including a threaded distal end portion that can pass freely through the tube 152 and a central opening 168 through the main body 149 of the mounting member 148, at the base of the tube 152, which is located within the opening 156 through the vertebral fixation plate 126. The threaded end of the shaft 166 extends into and is mated in an internally threaded receptacle 170 in a front face of the graft body 144. The fastener 164 includes a radially-extending flange 172 located at an appropriate distance from the distal end of shaft 166 so that the flange 172 of the fastener 164 can be brought to bear against the retaining flange 160 at the flared outer end 158 of the tube 152 as the fastener 164 is screwed into the receptacle 170, to fasten the mounting member 148 tightly to the graft body 144.
[0072] As shown in
[0073] The recessed area 146 and the opening 156 may be oval, allowing the vertebral fixation plate 126 to move a greater distance in a lateral direction than in a longitudinal direction with respect to the mounting member 148, or they may be of another shape, if desired, so long as there is space surrounding the flange 160 permitting the vertebral fixation plate 126 to be rotated about the mounting member 148 with respect to the graft body 144, as indicated by the arrow 178 in
[0074] Referring to
[0075] The fastener 164 includes an externally threaded portion 184 spaced apart from the flange 172 in the direction opposite the threaded distal end of the shaft 166. A plate retainer 186 includes a tubular body portion 188 with internal threads that can engage the externally threaded portion 184 of the fastener 164. The plate retainer 186 includes a retainer, or pressing, flange 190 extending radially away from the distal end of the tubular body 188. The pressing flange 190 preferably has a diameter that is great enough to span the recessed portion 146 of the intervertebral fixation plate, and may have a depending outer rim to provide clearance for the flared outer end 158 of the tube 152. Tightening the retainer flange 190 along the fastener 164 and against the fixation plate 126 with the shaft portion 166 of the fastener 164 extending through the tube 152 of the mounting member 148, forces the interior or ceiling surface 198 of the receptacle 150 against the outer face 154 of the mounting member 148 and fixes the location of the vertebral fixation plate 126 with respect to the mounting member 144 and thus also with respect to the graft body 144 and the adjacent vertebrae 20 and 22.
[0076] The outer face 154 of the main body 149 of the mounting member 148 may be provided with a surface configuration adapted to resist relative movement and maintain the relative positions of the mounting member 148 and the vertebral fixation plate 126. For example, there may be a set of small ridges 194 radiating outwardly from the tube 152, as shown in a simplified view in
[0077] Since the vertebral fixation plate 126 is attached to the mounting member 148, a surgeon performing a vertebral fusion procedure can install the graft body 144 between the vertebrae 20, 22 to be fused and thereafter can install the mounting member 148 and the vertebral fixation plate 126 as a unit. Tightening the fastener 164 into the graft body 144 attaches the mounting member securely and in a fixed location on the graft body 144. The intervertebral fixation plate 126 can then be placed in what the surgeon estimates to be the required location and orientation with respect to the vertebrae to be fused and can be held there by screwing the plate retainer 186 down so that the pressing retainer flange 190 pushes the vertebral fixation plate 126 against the mounting member 148. The location and orientation of the vertebral fixation plate 126 can be adjusted if necessary after a radiographic check, as explained above. The plate retainer 186 can then be re-tightened to maintain the desired relationship between the vertebral fixation plate 126 and the vertebrae 20 and 22 while the screws 36 are installed through the vertebral fixation plate to fasten it to the vertebrae. For example, the fixation plate 126 has been moved from an initial position shown in
[0078] The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow.