The present teachings relate generally to orthopedic surgical procedures. More particularly, the present teachings relate to a system for fixating the cervical spine.
In certain orthopedic surgical procedures, it is necessary to secure multiple bones or bone portions relative to each other. For example, in certain spinal surgeries, the fusion of two or more vertebral bodies is required to secure a portion of the spinal column in a desired position. This need may be the result of physical trauma from fractures or dislocations, degenerative diseases, or tumors.
One such spinal fixation procedure involves the attachment of a prosthesis or plate to the anterior side of the cervical portion of the spine. The procedure requires anteriorly accessing the spine and securing a prosthetic plate to two or more cervical vertebrae. This allows fusion of the two or more cervical vertebrae in a particular orientation to facilitate healing or to alleviate a condition of a patient.
Various fusion plates and plating systems are known for anteriorly fusing the cervical spine. Examples of known plating systems are shown in commonly assigned U.S. Pat. No. 6,599,290, which is hereby incorporated by reference as if fully set forth herein. Such plates and plating systems must meet several requirements associated with spinal stability and system reliability over an extended period of use. Additionally, it may be further desirable to ensure that the bone fasteners placed into the bone through the plate do not loosen or back out from the plate. Furthermore, locking mechanisms for preventing loosening of the bone fasteners should adequately permit the removal of an associated bone fastener when required, and allow sufficient angular freedom for bone fasteners relative to a bone plate.
It remains desirable in the pertinent art to provide an improved bone plating system that addresses all the requirements discussed above.
In accordance with one aspect, the present teachings provide a bone plating system having a plate and a locking element. The plate has a bone screw aperture. The bone screw aperture is defined by a sidewall including first and second generally planar segments. The locking element is coupled to the plate and is at least partially positioned in the aperture. The locking element has an external geometry defining first and second generally planar surfaces and an internal geometry for receiving a head of a bone fastener and preventing the bone fastener from backing out of the plate. The locking element is expandable from a first state to a second state such that in the first state the locking element is permitted to articulate relative to the plate and in the second state the first and second substantially planar surfaces of the locking element engage the first and second substantially planar segments of the aperture sidewall, respectively, to prevent relative movement between the locking element and the plate.
In accordance with another aspect, the present teachings provide a bone plating system having a plate and a locking element. The plate has a bone screw aperture. The bone screw aperture is defined by a sidewall including first and second sidewall openings. The locking element is coupled to the plate and at least partially positioned in the aperture. The locking element has an internal geometry for receiving a head of a bone fastener and preventing the bone fastener from backing out of the plate and an external geometry defining first and second tabs extending into the first and second sidewall openings, respectively. The first and second tabs and sidewall openings are configured to normally allow articulation of the locking element relative to the plate in a first plane. At least one of the first and second tabs and at least one of the sidewall openings define cooperating stop surfaces for limiting a range of articulation in the first plane.
In accordance with yet another aspect, the present teachings provide a bone plating system having a plate with a bone screw aperture. The plating system additionally includes a constrained bone screw having a constrained head and a semi-constrained bone screw having a semi-constrained head. The plating system further includes a locking element at least partially positioned in the aperture and coupled to the plate for relative articulation within at least a first plane generally perpendicular to the plane of the plate. The locking element is configured to interchangeably receive both the constrained bone screw and the semi-constrained bone screw such that the respective constrained and semi-constrained heads are captured relative to the locking element for articulation with the locking element and prevented from backing out of the plate. The locking element is expandable from a first state to a second state such that in the first state the locking element is permitted to articulate relative to the plate and in the second state relative movement between the locking element and the plate is prevented. The constrained head is configured to expand the locking element to the second state when captured by the locking element. The locking element remains in the first state upon capture of the semi-constrained head.
In accordance with still yet another aspect, the present teachings provide a spinal plating system for securing a first vertebra and a second vertebra. The spinal plating system includes a plate and a locking element. The plate has first and second bone screw apertures for overlying the first vertebra and third and fourth bone screw apertures for overlying the second vertebra. At least one of the bone screw apertures is defined by a sidewall including first and second substantially planar segments. The first and second substantially planar segments include first and second sidewall openings, respectively. The locking element is at least partially positioned in the one of the apertures. The locking element has an external geometry defining first and second substantially planar surfaces and first and second tabs extending from the first and second substantially planar surfaces, respectively. The first and second tabs extend into the first and second sidewall openings, respectively. The locking element further includes an internal geometry for receiving a head of a bone fastener and preventing the bone fastener from backing out of the plate. The locking element is expandable from a first state to a second state such that in the first state the locking element is permitted to articulate relative to the plate and in the second state the first and second substantially planar surfaces of the locking element engage the first and second substantially planar segments of the aperture sidewall, respectively, to prevent relative movement between the locking element and the plate. At least one of the first and second tabs and at least one of the sidewall openings define cooperating stop surfaces for limiting a range of articulation in the sagittal plane.
Additional advantages and further areas of applicability of the present invention will become apparent from the following detailed description and appended claims. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
The following description is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. For example, although the present teachings are illustrated for internal fixation of the cervical spine, the present teachings can also be used for other orthopedic procedures in which it is necessary to secure two bone portions relative to one another.
With general reference to the drawings, various bone plating systems are illustrated. The bone plating systems will be understood to generally include a bone plate and bone fasteners or screws for securing the plate to bone. Additionally, the bone plating systems include locking elements or mechanisms for locking the bone fasteners relative to the respective plate. For ease of reference and despite differences between the various embodiments, reference character 10 has been used throughout the drawings to generally identify the various bone plating systems of the present teachings. Similarly, the bone plates are identified throughout with reference character 12, the locking elements are identified throughout with reference character 14, and the bone fasteners are identified throughout with reference character 16. The differences between the various embodiments will be addressed below and are further shown in the drawings.
With reference to
The bone plate or plate member 12 includes a first pair of nodes having a first nodule 20 and a second nodule 22. The first and second nodules 20 and 22 define first and second plate holes or bone screw apertures 24A and 24B, respectively. The first and second nodules 20 and 22 are generally laterally spaced apart from one another in a first direction. In the embodiment illustrated and in a manner to be more fully discussed below, the first and second bone screw apertures 24A and 24B are intended to receive the fasteners 16 for engaging a first vertebral body. In a similar manner, the plate member 12 includes a second pair of nodes having a third nodule 28 and a fourth nodule 30. The third and fourth nodules 28 and 30 define third and fourth plate holes or bone screw apertures 24C and 24D, respectively. Again, the third and fourth nodules 28 and 30 are generally spaced apart from one another in a lateral direction. The third and fourth bone screw apertures 24C and 24D are intended to receive the fasteners 16 for engaging a second vertebral body.
The plate member 12 is further shown to include a plurality of linking segments 36 which connect the first and second pairs of nodes. The linking segments 36 extend in a longitudinal or axial direction which is essentially perpendicular to the lateral direction in which the nodules 20, 22 and 28, 30 of the first and second pairs of nodes are spaced apart. The linking segments 36 define a viewing window 38. Explaining further, the viewing window 38 may permit intra-operative visualization of a bone graft, as well as post-operative visualization of bone graft consolidation and spinal orientation on an anterior/posterior x-ray.
As shown in the top view of
As particularly shown in
The plate 12 may be provided with chamfered cephalad and caudal edges. The chamfered edges may provide a smooth finish to the edges of the plate 12. The chamfered edges may decrease the chances of dysphasia and may also give a sleek lateral X-ray post-operatively. The chamfered cephalad and caudal edges are shown particularly in
The plate 12 may be provided with instrument fixation grooves 44. The instrument fixation grooves 44 may be cut along the medial/lateral edges of the plate 12 and may allow for fixation of instrumentation which seats into the grooves 44 without resting underneath the plate 12. In this manner, the instrumentation will not induce lifting of the plate 12 from a vertebral body. Instrumentation fixation undercuts may additionally be provided in the form of pockets on the underside of the plate 12 that are located at the cephalad and caudal ends and at the edges of graft visualization windows near fastener holes.
As particularly shown in dotted lines in
Referring now to
As illustrated, each of the bone fasteners 16A and 16B may generally include a head or head portion 46, a neck portion 48 and a shaft portion 50. The head portion 46 may include an upper portion 52 that tapers as it extends downwardly and a lower, circumferentially extending lip 54. The lip 54 may have a tapered lower surface 55. The upper portion 52 may be configured to cooperate with one or more insertion/removal tools in any manner well known in the art. The specific features of the shaft portion 50, such as thread pitch, shaft diameter, and the like, are a matter of design choice and surgical preference. The diameter of the lip 54 of the bone fastener 16 may be larger than an opening 56 of the locking element 14, thereby preventing the bone fastener 16 from passing completely through the locking element 14 and capturing the head portion 46 of the fastener 16.
The locking element 14 may be at least partially positioned in the respective aperture 24. In this regard, the locking element 14 may sit proud of the aperture 24 or may extend partially from the aperture 24 through its range of articulation. The locking element 14 may be in the form of a locking ring. More particularly, the locking element 14 may be a split locking ring and may be retained within the aperture 24.
As such, discrete fasteners or other locking mechanisms may be eliminated. As will be addressed further below, the locking element 14 may be expanded from a first state (see
As noted above, the outer geometry of the locking element 14 may be generally oval and the bone screw apertures 24 may be generally rectangular with rounded edges. Alternatively, the outer diameter of the locking element 14 may be circular, square or of any other suitable shape. The opening or thru-hole 56 in the locking element 14 may be generally circular. In certain applications, a central axis of the locking element thru-hole 56 may be offset approximately 0.010 in (0.25 mm) from a central axis of the locking element 14. As such, when the locking element 14 is placed in the aperture 24 in the plate 12, the central axis of the locking element 14 and the central axis of the aperture 24 may be offset approximately 0.005 in (0.125 mm). Resultantly, the central axis of the thru-hole 56 in the locking element 14 and the central axis of the aperture 24 may be offset approximately 0.015 in (0.375 mm). Alternatively, the respective axes may be aligned.
The inner geometry of the locking element 14 may define an enlarged and generally circular opening 57 for receiving at least a portion of the head 46 of the bone fastener 16. As will be addressed further below, the outer periphery of both the upper portion 52 of the head 46 and the lip 54 may engage the inner geometry of the locking element 14 in line contact such that the bone fastener 16 and the locking element 14 will articulate together relative to the plate 12.
In order for the locking elements 14 to capture the associated bone fasteners 16, the locking elements 14 may elastically flex or spring open and shut. In this regard, the locking element 14 may flex open to create a friction lock at the fastener/locking element and locking element/plate interfaces.
With reference to
In particular, the embodiment of
With continued reference to
The exterior geometry of the locking element 14 may be further configured to couple the locking element 14 to the plate 12. In certain applications, the exterior geometry may be configured to define the range of permissible movement of the locking element 14 relative to the plate 12. In this regard, the exterior geometry of the locking element 14 may include a pair of tabs 62 for coupling the locking element 14 to the plate 12 and defining the range of movement between the locking element 14 and the plate 12.
The tabs 62 on the locking element 14 may be disposed in the sidewall openings 42. In certain applications, the sidewall openings 42 may be formed as undercuts within the plate 12. The sidewall openings 42 may be positioned at laterally opposite sides of the aperture 24. The tabs 62 and sidewall openings 42 may cooperate to define the relative movement normally permitted between the locking element 14 and the respective aperture 24.
The sidewall openings 42 and associated tabs 62 on the locking element 14 may be any suitable shape and any suitable size. The shapes and sizes may be modified to increase or decrease angulation of the locking element 14 (and in turn the associated bone fastener 16) in the cephalad/caudal direction. Such increased angulation may be facilitated through modification of the tabs 62 and/or the plate 12 ensuring that the plate 12 (1) does not interfere with the angulation of the locking element 14; and (2) captures the tabs 62 in a way that allows the locking element 14 to maximize its angulation in the cephalad/caudal direction.
With particular reference to
As illustrated, the recess 66 may define a portion of a generally cylindrical shape. In the embodiment illustrated, the recess 66 provides for extreme angulation in one of the caudal or cephalad directions. Additional similar recesses may be defined to provide for extreme angulation in more than one direction. Further in the embodiment illustrated, in which the fastener 16 may angulate relative to the plate 12 approximately 30 degrees, the cylinder may extend at an angle of at least about 30 degrees relative to an axis of the aperture. It will be understood that the aperture axis is generally perpendicular to the plane of the plate 12. In certain applications, the cylinder may extend at an angle of at least approximately 25 degrees to the aperture axis. In particular applications, the cylinder may extend at an angle of at least approximately 30 degrees relative to the aperture axis. In embodiment illustrated, cylinder may extend at an angle of approximately 35 relative to the aperture axis.
As illustrated most clearly in
The shape and size of the tabs 62 may be determined by choosing a diameter equivalent to or smaller than the height of the sidewall opening 42 and connecting straight lines tangent to that circle at a predetermined angle which mirrors the desired extreme angulation requirements. If the original circle is neglected and the straight lines are connected to each other, a rhombus is formed. This rhombus creates a large surface area so that when the locking element 14 is angulated to its most extreme cephalad/caudal position, the edges of the rhombus bottom out on the upper and lower lips of the sidewall opening.
In the embodiment shown particularly in
The tab 62 and the sidewall opening 42 may define cooperating stop surfaces for limiting the range of articulation in the first plane. When the locking element 14 is articulated fully in a first direction (
Turning to
As shown particularly in
The cooperating geometries of the tabs 62 and the sidewall opening 42 may be modified to normally allow articulation of the locking element 14 relative to the plate 12 in the second plane. With reference to
In the embodiments illustrated throughout the drawings, the various locking elements 14 are adapted to interchangeably receive both fixed-angle bone fasteners 16A and variable-angle bone fasteners 16B. Alternatively, the internal geometry of the locking element 14 may vary in accordance with whether the locking element 14 is to be used with the constrained or fixed-angle bone fasteners 16A or with the semi-constrained or variable-angle bone fasteners 16B. When the locking elements 14 are paired with the corresponding bone fasteners 16A, 16B: (1) a mechanical lock is created such that the bone fastener 16A, 16B cannot back out of the construct in vivo; and (2) the bone fastener 16A, 16B may be inserted at any angle within a predetermined range. As discussed further below, the internal geometries may utilize a taper that can be used to splay the locking element 14 open to work with the fixed-angle bone fastener 16A, or an undercut that can work to capture the variable-angle bone fastener 16B.
With particular reference to
The cooperative action between the bone fasteners 16 and the locking elements 14 will be described in further detail with reference back to the cross-sectional views of
Upon seating the head 46 of the constrained fastener 16A (see
The semi-constrained fastener 16B may be arranged similarly to the fixed fastener 16A in that it may have the upper tapered portion 80 utilized in combination with the inner geometry of the locking element 14 to create a mechanical lock for precluding back-out of the fastener 16B. However, the semi-constrained fastener 16B does not rely on frictional interference between the locking element 14 and the fastener 16B. Instead, the upper portion of the head 46 of the semi-constrained fastener 16B is slightly undersized and the lip 54 of the fastener 16B snapping into the undercut 84 activates the mechanical lock. In this way, the locking element 14 is not splayed open to thereby cause it to lock by friction to the plate 12. Instead, the fastener 16B remains variable or semi-constrained, which allows for micro-motion and settling upon graft subsidence.
Similarly, both the constrained and semi-constrained fasteners 16A and 16B may be removed from the locking element 14 by applying pressure to a top surface 90 of the locking element 14 while the fastener 16 is forced upward. Due to the small amount of interference between the fastener 16 and the upper tapered portion 80 of the locking element 14, the fastener 16 itself may assist to reverse the locking process by splaying the locking element 14 open when the fastener 16 is forced upwards and the locking element 14 is held down. These cooperating geometries may provide for easy removal and rework when necessary.
Alternate designs for the upper tapered portion 80, the lower tapered portion 82, and the undercut 84 are shown in
The embodiment of
With reference to the various figures and particular reference to
In addition to the increased security of the construct due to increased surface area contact between components, this type of configuration may also make the construct stronger in compression. When the construct is under a compressive load, the bone fastener 16 desires to sweep in the cephalad or caudal direction towards the center of the plate 12. By having the aperture 24 trapezoidal in shape, the locking element 14 prevents the fastener 16 from moving in the sweeping motion by forcing the locking element 14 deeper into the wedge created by the angled trapezoidal geometry.
The described geometrical relationship between the locking element 14 and plate aperture 24 may also be reversed. In this regard, since the locking element 14 opens at an angle between approximately 1 and 10 degrees when the fastener 16A is placed into the locking element 14, material can be removed from the edges of the locking element 14 to accommodate for the angular splay. If material is removed from the locking element 14, the edges of the aperture 24 should remain parallel to one another. In this way, after the constrained fastener 16A is placed into the locking element 14 within the plate 12, the locking element 14 will splay open such that its walls align with the planar segments 40A and 40B defining the aperture 24, thereby causing a more secure lock due to increased surface area contact.
Increased rigidity may also be accomplished by using other geometric forms that give edges similar to those described above for both the plate aperture 24 and the walls of the locking element 14. For example, other means of obtaining similar geometries may utilize ovals, ellipses, shapes that consist of a series of straight lines, concave curves, and/or convex curves linked together, polygons with rounded corners, and polygons with sharp corners.
The plate aperture 24 may also be tapered as it passes though the plate 12 to provide extra strength to the construct. By having a taper greater than 0 degrees in which the top of the aperture 24 is smaller than the bottom of the aperture 24, the same wedging concept is created when the fastener 16 is placed at extreme angles in the cephalad/caudal direction. Alternatively, the top of the aperture 24 may be larger than the bottom of the aperture or the top and bottom of the aperture 24 may be equal. In the same way, when the fastener 16 beings to sweep from its extreme angulation towards the center of the plate 12, the tapering of the aperture 24 stops the motion of the fastener/locking element assembly by forcing the locking element 14 deeper into the wedge created by the tapered geometry.
The locking concept discussed above may also be applied to the locking element 14, rather than to the plate aperture 24. In this case, an angle greater than 0 degrees may be applied to the faces 60A, 60B of the locking element 14 from which the tabs 62 originate. The larger distance from face 60A to face 60B across the opening 56 in the locking element 14 may be located near the top surface 90 of the locking element 14 and the smaller distance would be near the bottom surface 92. Alternatively, the larger surface may be near the bottom surface 92 or the top and bottom of the aperture 24 may be equal. In this way, when the fastener 16 is placed in the locking element 14 at an extreme cephalad/caudal angulation and the construct is placed under compressive load, the locking element 14 will act as a wedge. The wedge impedes the motion of the fastener and holds it fixed to the plate 12 when the fastener/locking element assembly tries to sweep towards the center of the plate 12. This increased rigidity may once again be accomplished by using other geometric forms that define features similar to the ones described above.
Both of the tapered options described above may be used independently or in combination to help increase the rigidity of the constrained fastener 16B construct. In certain applications, the plate 12 may utilize both the trapezoidal geometries and the tapered geometries as discussed above. Similarly, the taper options discussed above with respect to the locking element 14 may also be used in the combination to help increase the rigidity of the constrained fastener 16B construct. Finally, one tapered locking element option may be paired with the tapered plate hole.
While specific examples have been described in the specification and illustrated in the drawings, it will be understood by those skilled in the art that various changes may be made and equivalence may be substituted for elements thereof without departing from the scope of the present teachings as defined in the claims. Furthermore, the mixing and matching of features, elements and/or functions between various examples may be expressly contemplated herein so that one skilled in the art would appreciate from the present teachings that features, elements and/or functions of one example may be incorporated into another example as appropriate, unless described otherwise above. Moreover, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope thereof. Therefore, it may be intended that the present teachings not be limited to the particular examples illustrated by the drawings and described in the specification as the best mode of presently contemplated for carrying out the present teachings but that the scope of the present disclosure will include any embodiments following within the foregoing description and any appended claims.
This application claims priority to U.S. Provisional Patent Application No. 61/024,698 filed 30 Jan. 2008, which application is herein expressly incorporated by reference.
Number | Date | Country | |
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61024698 | Jan 2008 | US |