Not applicable.
Not Applicable.
The present invention relates to fixation devices used in orthopaedic and spinal surgery and particularly to bone fixation plates useful for positioning and immobilizing bone segments.
For a number of known reasons, bone fixation devices are useful for promoting proper healing of injured or damaged vertebral bone segments caused by trauma, tumor growth, or degenerative disc disease. The fixation devices immobilize the injured bone segments to ensure the proper growth of new osseous tissue between the damaged segments. These types of bone fixation devices often include internal bracing and instrumentation to stabilize the spinal column to facilitate the efficient healing of the damaged area without deformity or instability, while minimizing any immobilization and post-operative care of the patient.
One such device is an osteosynthesis plate, more commonly referred to as a bone fixation plate, that can be used to immobilize adjacent skeletal parts such as bones. Typically, the fixation plate is a rigid metal or polymeric plate positioned to span bones or bone segments that require immobilization with respect to one another. The plate is fastened to the respective bones, usually with bone screws, so that the plate remains in contact with the bones and fixes them in a desired position. Bone plates can be useful in providing the mechanical support necessary to keep vertebral bodies in proper position and bridge a weakened or diseased area such as when a disc, vertebral body or fragment has been removed.
Such plates have been used to immobilize a variety of bones, including vertebral bodies of the spine. These bone plate systems usually include a rigid bone plate having a plurality of screw openings. The openings are either holes or slots to allow for freedom of screw movement. The bone plate is placed against the damaged vertebral bodies and bone screws are used to secure the bone plate to the spine, usually with the bone screws being driven into the vertebral bodies. Exemplary systems are described in U.S. Pat. No. 6,159,213 to Rogozinski; U.S. Pat. No. 6,017,345 to Richelsoph; U.S. Pat. No. 5,676,666 to Oxland et al.; U.S. Pat. No. 5,616,144 to Yapp et al.; U.S. Pat. No. 5,549,612 to Yapp et al.; U.S. Pat. No. 5,261,910 to Warden et al.; and U.S. Pat. No. 4,696,290 to Steffee.
Despite the existence of these bone plate systems, there remains a need for a bone plate system that can be implanted with a minimum number of steps and with minimal tissue retraction, tissue dissection, and damage.
Disclosed herein are bone plate systems comprising a bone plate and bone screws having unique geometry and dimensions that minimize the width of the plate. In one aspect, the bone plate has a width that is less than that of conventional bone plates, and the bone screws used with the plate have a larger major diameter than conventional bone screws. Combined, these features facilitate bone plate fixation with minimal damage to soft tissue and bone, and also allow implantation of the bone plate system with fewer steps.
The narrow width of the bone plate is advantageous as it reduces trauma to soft tissue by requiring minimal tissue retraction and dissection for implantation. As a result, patients suffer less discomfort and can recover more quickly. In addition, the large diameter of the bone screws provide enhanced fixation such that fewer bone screws are required. For example, in one embodiment, it is possible to implant the plate using only one bone screw per vertebral body. Compared with conventional bone plates, the present system can thus reduce the magnitude of osseous tissue damage incurred by bone structures due to bone screws. As a further advantage, the number of steps required to implant the bone plate system is reduced because the number of screws a surgeon must implant is reduced.
In one embodiment, the bone plate system comprises an elongate bone plate having a first surface, a second bone-contacting surface opposed to the first surface, a maximum plate width, and a plurality of apertures extending through the plate from the first surface to the second surface. The system also includes a plurality of bone screws matable within the apertures for insertion into bone, each screw having a major screw diameter. The dimensions of the bone plate and bone screws are such that, in an exemplary embodiment, the ratio of the maximum plate width to the major screw diameter is less than or equal to approximately 2.7.
In one aspect, the bone plate system includes additional features such as a locking mechanism for preventing bone screw backout. The bone plate can also include bone-engaging protrusions extending from at least one surface of the plate to provide enhanced rotational and torsional stability. These protrusions can extend from a side edge of the bone plate.
In another aspect, the apertures in the bone plate are aligned along a longitudinal axis of the bone plate. In this embodiment, each aperture is adapted to be positioned adjacent a different vertebral body.
In another embodiment, a bone plate has a first surface and an opposed second, bone-contacting surface, and a plurality of apertures extending through the bone plate from the first surface to the second surface, such that each of the plurality of apertures is adapted to receive a bone screw and is aligned with a longitudinal axis of the bone plate. The bone plate further includes an integrated retaining member to inhibit backout of a screw from the apertures. Moreover, the bone plate has a width that varies along the longitudinal axis including a maximum width and a minimum width, wherein the ratio of the maximum width to a minimum diameter of the apertures, measured in a direction transverse to the longitudinal axis, is less than or equal to approximately 2.5.
In a further embodiment, the bone plate system includes a bone plate having a superior end, a central portion, an inferior end, a first surface, and a second, bone-contacting surface opposed to the first surface. The bone plate includes a plurality of apertures extending therethough from the first surface to the second surface. The system also includes a plurality of bone screws implantable within the apertures for insertion into bone, each screw having a major screw diameter. The bone plate also includes a width which may vary along a portion of its length.
In yet another aspect, the bone plate system includes a bone plate having a first surface and a second bone-contacting surface opposed to the first surface, and a plurality of apertures extending from the first surface to the second surface for receiving bone screws. The apertures can be positioned along a longitudinal axis of the bone plate and spaced such that each aperture is adapted for placement adjacent to a different vertebral body. The bone plate can have an elongate shape with a width that varies along the longitudinal axis of the bone plate, wherein a maximum width is less than or equal to approximately 10.5 mm. The system also includes a plurality of bone screws capable of insertion through an aperture into bone, wherein each screw has a major screw diameter of at least approximately 4.6 mm.
In an additional aspect, the bone plate can include a portion with a greater width than other portions of the bone plate. The portion of greater width may have two apertures oriented transverse to a longitudinal axis of the bone plate and adapted for placement adjacent the same vertebral body. In one embodiment, the bone plate also includes at least one additional aperture at a portion of the plate having a lesser width and the ratio of the bone plate width at the portion of the plate having a lesser width, measured across the at least one additional aperture, to the major bone screw diameter is equal to or less than approximately 2.5.
In yet another aspect, the bone plate includes a portion having a wider width at one end of the bone plate. The wider end of the plate preferably includes multiple apertures arranged across the wider width, the multiple apertures being oriented transverse to a longitudinal axis of the plate and each aperture being adapted for placement adjacent to the same vertebral body. The end of the plate having a lesser width preferably includes at least one aperture, each aperture in the end having a lesser width is aligned with the longitudinal axis of the plate and is adapted for placement adjacent to a different vertebral body. In one embodiment, the ratio of the plate width as measured across an aperture in the narrow end to the major screw diameter is less than approximately 2.7.
The present invention also encompasses methods of implanting a bone plate system. In one embodiment, the method includes providing an elongate bone plate having a first surface, a second bone-contacting surface opposed to the first surface, a maximum plate width, a minimum plate width, and a plurality of apertures extending therethrough from the first to the second surface for receiving bone screws. A plurality of bone screws are also provided, each screw having a major screw diameter and a minor screw diameter, wherein the ratio of the maximum plate width to the major screw diameter is less than or equal to approximately 2.7. The method further includes the steps of creating at least one incision to provide access to a site on or adjacent to a patient's spinal column, inserting the bone plate through the at least one incision, and placing the bone plate at a desired location spanning at least two vertebral bodies. The bone screws are then inserted through the at least one incision and through an aperture in the bone plate. In one exemplary technique, each bone screw is implanted in a different vertebral body.
The invention can be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
In general, disclosed herein are spinal fixation plates having at least two apertures for receiving a bone screw. The plate may be adapted to be attached to adjacent vertebrae to maintain the vertebrae in a fixed position and thereby provide biomechanical stability to the vertebrae. The shape and structure of the bone plate system facilitate its use in a variety of surgical procedures, including minimally invasive surgical procedures. In one aspect, the plate has a width that is narrower than conventionally used bone plates, permitting the use of a smaller incision. In addition, the bone screws used with the plate system have a larger major diameter than conventional bone screws. As a result, fewer bone screws are needed to affix the plate to bone, and it is possible to use only a single bone screw for each vertebral body to which the plate is to be affixed, thus reducing the time and number of steps required by a surgeon to implant the plate.
The following exemplary embodiments are described herein with reference to bone plates used to span and immobilize adjacent vertebral bodies in spinal fixation techniques. However, it is understood that the bone plate systems described herein may be applicable to the fixation of any type of adjacent bones or bone segments.
As indicated above, plate 12 is adapted to mate to at least two vertebrae. The system and plate illustrated in
Bone plate 12 can have a variety to shapes, however, the bone plate generally includes a non-uniform width along its length. In one embodiment, the bone plate has a substantially hourglass shape as illustrated in
Apertures 14 in bone plate 12 can have a variety of shapes, as long as they are suitable to receive a fixation element. In one exemplary embodiment, the apertures 14 can be generally circular. In another embodiment, including the illustrated embodiment, the apertures can be in the form of a circle that is slightly elongated in the longitudinal direction. One or more apertures 14 include a diameter that may vary between the non-bone-contacting surface 26 and the bone-contacting surface 28. In one exemplary embodiment, one or more of the apertures 14 has a diameter that tapers from the non-bone contacting surface 26 to the bone-contacting surface 28. For example, as shown in
The spacing between apertures 14 depends on distance between vertebral bodies (and/or bone grafts) along the length of a patient's spinal column. In one embodiment, where the bone plate is adapted to provide a single screw per vertebral body (or bone graft), the exemplary hole-to-hole spacing between apertures is preferably in the range of approximately 8 mm to approximately 25 mm. In one embodiment, the ratio of plate width to hole-to-hole spacing is preferably in the range of approximately 0.2 to approximately 1.0, and even more preferably in the range of approximately 0.3 to approximately 0.9.
Bone plate 12 also includes a bone plate thickness T (
In an exemplary embodiment, the plate 12 is adapted to be mounted upon the anterior surface of vertebrae in the cervical or lumbar region of the spine. For example, the bone-contacting surface 28 of the exemplary plate 12 can have a longitudinal curve X that approximates the lordotic curvature of the vertebrae upon which the plate is to be mounted. As shown in
While the exemplary plate 12 may be curved only along longitudinal axis L, in another embodiment, plate 12 can also include a transverse curve Y that approximates the transverse curvature of the vertebrae upon which the plate is to be mounted, as illustrated in
The bone screws 16 useful with the present system preferably have a larger diameter than conventional bone screws used for fixing a bone plate to a vertebral segment.
In one embodiment, the dimensions of the bone plate and the bone screws are adapted such that the ratio of the maximum plate width to the major screw diameter is less than or equal to approximately 2.7. In another embodiment, maximum plate width to the major screw diameter is preferably in the range of approximately 1.1 to approximately 2.7, more preferably in the range of approximately 1.5 to approximately 2.5, and even more preferably in the range of approximately 1.9 to approximately 2.5. In an exemplary embodiment, the range is approximately 2.0 to approximately 2.3.
In one aspect of the present system, the major diameter of bone screw 16 is larger than the major diameter of conventional bone screws. The major screw diameter SD1 for a standard screw used with system 10 is in the range of approximately 4.4 to approximately 5.0 mm. In an exemplary embodiment, the major screw diameter of a standard screw is equal to or more than approximately 4.6 mm. In another embodiment, system 10 can include oversized revision screws, which are particularly useful when a problem is encountered with implanting the screws (e.g., a new oversized hole must be drilled in place of an existing hole in a vertebral body). In one embodiment, the oversized revision screws have a major diameter in the range of approximately 5.0 mm to approximately 5.6 mm. In an exemplary embodiment, the oversized revision screws have a major screw diameter of approximately 5.2 mm. In yet another aspect, the major diameter of the revision screw is at least 0.6 mm greater than the major diameter of the standard screw.
The bone plate system may include different types of bone screws having varying functionalities. For example, the bone screws can be of a rigid type in which after a screw locking mechanism is engaged, movement of the screw in any direction is prevented. The bone screws can also be of a semi-rigid type in which after a screw locking mechanism is engaged, screw backout is prevented, but the screw is able to move in all directions (i.e., polyaxially). Further, the bone screws can also be of a hybrid type in which after a screw locking mechanism is engaged, screw backout is prevented, but the screw is able to move in only one selected direction (e.g., the superior-inferior or the transverse direction). Moreover, the bone screws may translate within an aperture of a plate. For example, a bone screw may translate along the length of an elongated slot defining an aperture in the plate. One skilled in the art will appreciate that a bone plate system may be provided having any single screw type or a combination of all or any of the screw types.
As noted above, the present bone plate system also encompasses multi-level plates, such as a two level plate 112 shown in
The multi-level plates may include the features of the single level bone plates described above, and thus the dimensions and geometry of the multi-level plates are similarly adapted for a variety of surgical procedures, including minimally invasive surgical procedures. That is, the ratios and dimensions discussed above with respect to a single level plate are equally applicable to multi-level plates.
The present system also encompasses plate system designs in which only a portion of the plate has the dimensions and geometry discussed above. That is, only a portion of the plate is designed such that only a single aperture will be placed adjacent a vertebral body while another portion of the plate can have more traditional or alternative designs. In one embodiment, the bone plate can include an extra wide portion that includes multiple screw apertures adapted to be positioned adjacent to a single vertebral body. Examples of such designs are illustrated in
The plates illustrated in
The bone plate 212, 212′, 212″ illustrated in
In an alternative embodiment, illustrated in
The various embodiments of the bone plate system can include additional features that provide bone plate stabilization. For example, the bone contacting surface of the bone plate may include surface features that facilitate engagement of the plate to a surface of a vertebra. In the exemplary plate 12 described above, for example, the bone-contacting surface 28 of the plate 12 may include one or more cleats 29 to facilitate engagement of the bone contacting surface 28 to a surface of a vertebra. The cleats 29, in the exemplary embodiment, are oriented transverse to the longitudinal axis L of the plate 12 and span the width of the plate 12. The bone plates may include other surface features. For example, in one embodiment, the bone plate (12, 112, 212) includes one or more bone-engaging spikes positioned adjacent to the lateral edge of the bone plate. As shown in
One skilled in the art will appreciate that the bone-engaging spikes 50 can be positioned anywhere along the edge of the bone plate, or elsewhere on the bone-contacting surface of the plate. In one embodiment, the bone-engaging spikes are positioned on the edge of the bone plate at the maximum plate width. In another embodiment, at least one set of bone-engaging spikes is positioned adjacent an aperture, and in yet another embodiment, bone-engaging spikes are positioned adjacent to each aperture.
The various embodiments of the bone plate system can additionally include a locking or retaining mechanism 18 for preventing bone screw backout. For example, the bone plate (12, 112, 212) can include an integrated locking mechanism present on the non-bone-contacting surface of the plate 12. The integrated locking mechanism can be in the form of a rotatable cam 52 which can be rotated between a locked and an unlocked position.
The exemplary bone plate systems described herein may be constructed of any biocompatible material including, for example, metals, such as stainless steel and titanium, polymers, and composites thereof. In certain exemplary embodiments, the bone plate system may be constructed of a bio-resorbable material, such as, for example polylactic acid (PLA) and polyglycolic acid (PGA), and blends or copolymers thereof.
The bone plate system, as described above, can be implanted by any type of surgical procedure, including minimally invasive surgical techniques. For example, the exemplary bone plate systems described herein may be implanted through a minimally invasive access system, including for example a port or a retractor. Exemplary minimally invasive access systems and methods are described in U.S. Pat. No. 6,159,179; U.S. Patent Application Publication No. 2003/0083689; U.S. Patent Application Publication No. 2003/0083688; and U.S. Patent Application Ser. No. 60/589,727, filed Jul. 21, 2004, each of which is incorporated herein by reference. One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.