Patent Description:
This application is a continuation-in-part application of <CIT>, entitled "Bone Fusion Device, System And Methods", which application is a continuation of International Application No. <CIT>, entitled "Bone Fusion Device, System And Methods" and published under the PCT Articles in English as <CIT>, which application claimed priority from <CIT>, entitled "Bone Fusion Device, System And Methods".

The present disclosure relates generally to general surgery, orthopaedic and neurosurgical implants used for insertion within a patient's vertebrae. More specifically, but not exclusively, the present disclosure related to implant systems having a plate or an implant operable with insertion guides for establishing screw trajectories in a patient's spine. The plate or implant may also be operable in a bone fusion system with fixations elements and devices such as screws to maintain or re-establish proper spacing and alignment of a patient's spine. As used herein the term plate, implant, body, member may be used interchangeably and are not to be limiting.

Spinal deformities may result from disease, age, or trauma causing destabilization of the spine. To correct destabilization of a patient's spine, fusion devices and systems may be used. Posterior lumbar spinal fusion with pedicle screws is the most common way to fuse a patient's spine. However, the pedicle screw fusion and surgical technique used for these fusions has not changed in the last <NUM> to <NUM> years. Moreover, the large number of necessary parts and pieces involved to complete these fusions increases risk, surgical time, potential for construct failure, and cost.

When a patient presents with a spondylolisthesis or a displacement of a spinal vertebra in relation to the vertebra below, which needs to be fixed prior to inserting stabilization devices, for example, screws. Thus, improved fusion and/or fixation devices, systems and instrumentation are needed. <CIT> discloses a plate that is useful for understanding the invention.

The present disclosure provide bone fusion devices, systems, instruments and methods (not claimed) of using the same.

Shortcomings of the prior art are overcome and additional advantages are provided through the provision in one embodiment of an insertion guide assembly for use in implanting a plate in an anatomical structure. The insertion guide assembly includes, for example, an insertion guide having a body with a first portion and a second portion. The second portion has a plate engaging portion. A passageway extends through the first portion, the second portion, and opens onto the plate engaging portion with the passageway defining a longitudinal axis. The body defining a first guide passageway with a first guide trajectory extending from the first portion to the second portion and opening onto the plate engaging portion. The body defines a second guide passageway with a second guide trajectory extending from the first portion to the second portion and opening onto the plate engaging portion. A plate holder is extendable through the passageway of the body from the first portion to the second portion. The plate holder has a distal end engageable with the plate to secure the plate to the plate engaging portion of the second portion of the body. The plate holder has a passageway aligned with the passageway of the body. A docking pin is extendable through the passageway of the plate holder and extendable through the plate.

In another embodiment, a plate includes, for example, a body having a first surface and a second surface, a first opening at a first end of the body extending from the first surface to the second surface, a second opening at a first end of the body extending from the first surface to the second surface, a third opening positioned between the first opening and the second opening and extending from the first surface to the second surface, and the first surface defines a first boss extending around at least a portion of the first opening, and the first surface defines a second boss extending around at least a portion of the second opening.

A surgical method (not claimed) includes, for example, providing an implant assembly having a plate secured to an insertion guide; positioning the plate adjacent to an anatomical structure; inserting a pin through the insertion guide and the plate, and into the anatomical structure; inserting a first guide wire through the insertion guide and the plate along a first trajectory into the anatomical structure; inserting a second guide wire through the insertion guide and the plate along a second trajectory into the anatomical structure; removing the insertion guide from the plate and the inserted guide wires; inserting a first fixation element over the first guide wire, through the plate, and into the anatomical structure; inserting a second fixation element over the second guide wire, through the plate, and into the anatomical structure; and removing the first guide wire and the second guide wire from the anatomical structure so that the plate and the first and second fixation element form a bone fusion system in the anatomical structure.

In another embodiment, provided herein is an implant system having a plate, a first insertion guide, and a second insertion guide. The plate includes a first channel extending therethrough having a first axis defining first trajectory, and a second channel extending therethrough having a second axis defining a second trajectory. The first trajectory extends at an angle opposite the direction of the second trajectory. The first insertion guide includes a first passageway therethrough, and the second insertion guide includes a second passageway therethrough. A lower end of the first insertion guide is releasably attachable to the plate so that the first passageway is alignable with the first trajectory, and a lower end of the second insertion guide is releasably attachable to the plate so that the second passageway is alignable with the second trajectory.

In another embodiment, the lower end of the first insertion guide is releasably receivable in the first channel of the plate, and the lower end of the second insertion guide is releasably receivable in the second channel of the plate.

In another embodiment, the first channel includes an internal threaded upper portion, a seat, and a lower cylindrical portion, the second channel includes a threaded upper portion, a seat, and a lower cylindrical portion, the first insertion guide includes a lower portion having a stop, an external threaded portion, and a lower cylindrical portion, and the second insertion guide includes a lower portion having a stop, an external threaded portion, and a lower cylindrical portion.

In another embodiment, provided herein is a surgical method (not claimed) for using the implant system.

A surgical method (not claimed) includes, for example, attaching a lower portion of a first insertion guide having a first passageway therethrough to an plate having a first channel extending therethrough having a first axis defining a first trajectory, inserting the plate and the lower portion of the first insertion guide into a patient adjacent the vertebrae, attaching a lower portion of a second insertion guide having a second passageway therethrough to the plate having a second channel extending therethrough having a second axis defining a second trajectory.

A surgical method (not claimed), which includes, for example, providing the above-described plate; positioning the plate adjacent to an anatomical structure; inserting a first elongated member through the first opening of the plate and into the anatomical structure; inserting a second elongated member through the second opening of the plate and into the anatomical structure; verifying the placement of the plate, the first elongated member, and second elongated relative to the anatomical structure; inserting a first fixation element through the plate and into the anatomical structure; inserting a second fixation element through the plate and into the anatomical structure; and removing the elongated member and the second elongated member from the anatomical structure so that the plate and the first and second fixation element form a bone fusion system in the anatomical structure.

A surgical method (not claimed) which includes, for example, providing a plate having a first surface and a second surface, a first opening at a first end of the body extending from the first surface to the second surface and the first opening defining a first trajectory, a second opening at a first end of the body extending from the first surface to the second surface and the second opening defining a second trajectory, and the first trajectory extends at an angle opposite a direction of the second trajectory; positioning the plate adjacent to an anatomical structure; inserting a first cannula through the first opening of the plate and into the anatomical structure, and inserting a second cannula through the second opening of the plate and into the anatomical structure; verifying the placement of the plate, the first cannula, and the second cannula relative to the anatomical structure; inserting a first guide wire through the first cannula and into the anatomical structure, and inserting a second guide wire through the second cannula and into the anatomical structure; removing the first cannula from the first guide wire, and removing the second cannula from the second guide wire; inserting a first fixation element over the first guide wire, through the plate, and into the anatomical structure, and inserting a second fixation element over the second guide wire, through the plate, and into the anatomical structure; and removing the first guide wire and the second guide wire from the anatomical structure so that the plate and the first and second fixation element form a bone fusion system in the anatomical structure.

These, and other objects, features and advantages of this disclosure will become apparent from the following detailed description of the various aspects of the disclosure taken in conjunction with the accompanying drawings.

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the present disclosure and together with the detailed description herein, serve to explain the principles of the disclosure. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the present disclosure.

Generally stated, disclosed herein are implant systems and bone fusion systems. Further, surgical methods (not claimed) employing the systems are also discussed. As will be appreciated, the present disclosure may provide a trivergent spinal fixation. For example, the trivergent stabilization may result in divergence in three dimension, which may contribute to increased stability <NUM>) Cephalad-Caudal, <NUM>) Medial-Lateral, and <NUM>) Lateral right and lateral left. As will be further appreciated, the cephalad directed screw engages two cortices and the pedicle, similar to pedicle cortical trajectory. The caudal directed screw engages four cortical surfaces, similar to transfacet trajectory.

In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior, inferior, cephalad and caudally are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, "proximal" means the portion of an implant nearest the insertion instrument, while "distal" indicates the portion of the implant farthest from the insertion instrument. As for directional terms, "anterior" is a direction towards the front side of the body, "posterior" means a direction towards the back side of the body, "medial" means towards the midline of the body, "lateral" is a direction towards the sides or away from the midline of the body, "superior" means a direction above and "inferior" means a direction below another object or structure, "cephalad" means a direction toward the head and "caudally" means a direction toward the inferior part of the body.

Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to <FIG> and <FIG> therein illustrated are exemplary midline incision implant systems, for example, a midline incision implant system <NUM> (<FIG>), a midline incision implant system <NUM> (<FIG>), a midline incision implant system <NUM> (<FIG>), a midline incision implant system <NUM> (<FIG>), and surgical methods (<FIG> and <FIG>), according to embodiments of the present disclosure. For example, as shown in <FIG>, the midline incision implant system <NUM> may generally include an insertion guide assembly <NUM> and a plate <NUM>, according to an embodiment of the present disclosure.

With particular reference to <FIG>, therein illustrated are exemplary embodiments of a percutaneous implant system <NUM> and surgical methods. For example, as shown in <FIG>, the percutaneous implant system <NUM> may generally include a first insertion guide <NUM>, a separate second insertion guide <NUM>, and a plate <NUM>, according to an embodiment of the present disclosure.

In some of the illustrated embodiments of the present disclosure, the implant systems may be secured to a plate during a surgical procedure to aid a surgeon in establishing fixation element trajectories relative to a surgical incision. The plate, in addition to aiding guidance for providing fixation element trajectories, may also be operable in a bone fusion system for use in connection with a first plate fixation element such as a screw and second plate fixation element such as a screw in an anatomical structure such as to maintain or re-establish proper spacing and alignment within a patient's spine. In some embodiments, the plate itself may be used for providing the trajectories along with elongated members such as cannulas and/or guide wires (e.g., without insertion guides) for locating, aligning, and/or orientating the plate and subsequently installing the fixation elements.

With reference to <FIG>, the midline incision implant system <NUM> (<FIG>) may be operably attachable to a table mount <NUM> (<FIG>), according to an embodiment of the present disclosure. In this illustrated embodiment, the midline incision implant system <NUM> (<FIG>) may generally include the insertion guide assembly <NUM> having, for example, an insertion guide <NUM>, a plate holder <NUM>, a docking pin <NUM>, and a handle <NUM>, according to an embodiment of the present disclosure.

As described in greater detail below, for example, shown in <FIG> and <FIG>, the plate holder <NUM>, extends through the insertion guide <NUM> with a distal end <NUM> (<FIG>) attachable to the plate <NUM> (<FIG>) to secure the plate <NUM> (<FIG>) in a fixed relationship relative to the insertion guide assembly <NUM>. The docking pin <NUM> extends through the plate holder <NUM>. During a surgical procedure a distal end <NUM> of the docking pin <NUM> is secured into the facet/lamina of a patient's spine, which distal end <NUM> of the docking pin <NUM> along with the table mount <NUM> (<FIG>), stabilize the insertion guide assembly <NUM> and the plate <NUM> (<FIG>) relative the spine of the patient. During a surgical procedure, the insertion guide assembly <NUM> and the plate <NUM> (<FIG>) establish fixation element trajectories T1 and T2 (<FIG>) relative to a surgical incision. The plate <NUM> and a first plate fixation element such as a screw and a second plate fixation element <NUM> such as a screw are operable in a bone fusion system for maintaining or re-establishing proper spacing and alignment within a patient's spine.

With reference to <FIG>, the insertion guide <NUM> may include, for example, a body <NUM> having an upper portion <NUM>, a lower portion <NUM>, and a connecting member <NUM> extending between the upper portion <NUM> and the lower portion <NUM>. For example, the connecting member <NUM> may include a first end <NUM> attached to the upper portion <NUM> and a second end <NUM> attached to the lower portion <NUM>. In some embodiments, the insertion guide may have a generally T-shaped configuration. It will be appreciated that the body may have other suitable configurations.

As shown in <FIG>, and <FIG>, the upper portion <NUM> may be a generally elongated member with a top surface <NUM> opposite a bottom surface <NUM>. The lower portion <NUM> may be a generally elongated member with a top surface <NUM> opposite a plate engaging portion <NUM>.

As shown in <FIG>, a passageway <NUM> extends through the upper portion <NUM>, the connecting member <NUM>, and the lower member <NUM> of body <NUM>. The passageway <NUM> defines an axis A (also shown in <FIG> and <FIG>). The passageway <NUM> may be used to aid in alignment of the insertion guide assembly <NUM> (<FIG>) and the plate <NUM> (<FIG>) as described below.

With reference again to <FIG> and <FIG>, the upper portion <NUM> at a first distal end may include a first opening <NUM>, and at a second distal end a second opening <NUM>. The first opening <NUM> may extend through the upper portion <NUM> from the top surface <NUM> to the bottom surface <NUM> of the upper portion <NUM>. The second opening <NUM> may extend through the upper portion <NUM> from the top surface <NUM> to the bottom surface <NUM> of the upper portion <NUM>.

With reference to <FIG>, the lower portion <NUM> may be a generally elongated member with the top surface <NUM> opposite the plate engaging portion <NUM>. The lower portion <NUM> at a first distal end may include a first opening <NUM>, and at a second distal end a second opening <NUM>. The first opening <NUM> may extend through the lower portion <NUM> from the top surface <NUM> to the plate engaging portion <NUM> of the lower portion <NUM>. The second opening <NUM> may extend through the lower portion <NUM> from the top surface <NUM> to the plate engaging portion <NUM> of the lower portion <NUM>.

With reference again to <FIG> (the section being taken as shown in <FIG>), the first opening <NUM> of the upper portion <NUM> and the first opening <NUM> of the lower portion <NUM> have aligned axes, which axes define the first trajectory T1, which may be angled in a first direction. The second opening <NUM> of the upper portion <NUM> and the second opening <NUM> of the lower portion <NUM> have aligned axes, which axes define the second trajectory T2, which may be angled in a second direction. The second direction may be opposite the first direction. The first and second trajectories may be selected, for example, to correspond to the desired placement in a patient's facet and/or pedicle. In an embodiment, the openings <NUM> and <NUM> may be, for example, angled approximately <NUM>-<NUM> degrees from the top surface <NUM> of the upper portion <NUM> of body <NUM>, however, other angles are also contemplated to correspond to variations in patient anatomy.

As shown in <FIG>, the first and second trajectories T1 and T2 may be positioned and offset to extend past each other on opposite sides of distal end <NUM> of docking pin <NUM> to allow for, as described below, the insertion of fixation fasteners or screws (not shown) in a crossed or X-shaped arrangement. With reference again to <FIG>, portions <NUM> and <NUM> of the distal ends of the upper portion <NUM> of the body <NUM> may be angled parallel to the first opening <NUM> and the second opening <NUM>, respectively.

As best shown in <FIG>, the upper portion <NUM> may include slots or slot features <NUM> and <NUM> in the insertion guide <NUM>. The bottom portion <NUM> may include slots or slot features <NUM> and <NUM>. The slots or slot features allow for the insertion guide <NUM> to be separated from guide wires (not shown) inserted in the openings of the insertion guide and plate as described further below.

With reference again to <FIG>, the lower portion <NUM> of insertion guide assembly <NUM> (<FIG>) may include the top surface <NUM> opposite the plate engaging portion <NUM>. The plate engaging surface <NUM> may be configured to register and properly align the plate <NUM> (<FIG>) in position relative to insertion guide assembly <NUM>. For example, the plate engaging portion <NUM> may have a center portion <NUM>, a first angled recess <NUM> and a second angled recess <NUM> relative to axis A (<FIG>), which as described below correspond to the shape of bosses <NUM> and <NUM> (<FIG>) on the plate <NUM> (<FIG>).

With reference to <FIG> and <FIG>, the handle <NUM> may be operably attachable to body <NUM> of insertion guide <NUM> and to the table mount <NUM> (<FIG>). The handle <NUM> may include an elongated body <NUM> having a first end portion <NUM> and a second end portion <NUM>. The second end portion <NUM> may have a cavity <NUM> (<FIG>) configured or sized and shaped to receive a first end <NUM> of a table mount connector <NUM>, and attached together with a pin <NUM> (<FIG>) extending through aligned openings. A second end of the table mount connector <NUM> may include a circular portion <NUM> having spaced apart teeth <NUM> as shown in <FIG>, to allow insertion guide assembly <NUM> to be rotatable about an axis Y.

With reference again to <FIG> and <FIG>, the first end <NUM> of handle <NUM> may have a post <NUM> having six sides, which post is receivable in a corresponding shaped cavity <NUM> (<FIG>) having a hexagon cross-section.

As shown in <FIG> and <FIG>, a connector <NUM> may include an internally threaded first end <NUM> for threadably attaching to external threads <NUM> of body <NUM>, and a counter bore <NUM> (<FIG>) for receiving end portion <NUM> of handle <NUM>. The end portion <NUM> includes an outwardly-extending ridge <NUM>. The handle <NUM> is rotatably attached to connector <NUM> by inserting end <NUM> into the connector <NUM>, and as shown in <FIG>, installing square pins <NUM> into opening <NUM> in connector <NUM>. Thereafter, the connector <NUM> is threadably attached to the threaded end <NUM> of body <NUM>. For example, post <NUM> is inserted and received into cavity <NUM> as the connector <NUM> is rotated.

With reference now to <FIG>, <FIG>, and <FIG>, the plate holder <NUM> includes a knob <NUM> having a cavity <NUM> (<FIG>) with internal threads <NUM> (<FIG>), and an elongated hollow shaft <NUM>. The elongated shaft <NUM> is receivable in the passageway <NUM> (FIG. <NUM>) of body <NUM> of the insertion guide <NUM>. The elongated shaft <NUM> also include a passageway <NUM> (<FIG>). The threaded distal end <NUM> of the elongated hollow shaft <NUM> includes a passageway <NUM> (<FIG>). As described below, the threaded distal end <NUM> is attachable to the plate <NUM> (<FIG>).

The docking pin <NUM> includes a knob <NUM> having an externally threaded end <NUM>, and an elongated pin <NUM>. The elongated pin <NUM> is receivable in the passageway <NUM> (<FIG>) of the plate holder <NUM>. A distal end <NUM> of the elongated pin <NUM> may include a reduced diameter that is received and passes through passageway <NUM> (<FIG>) of threaded connector <NUM> of plate connector <NUM>.

Referring now to <FIG>, the plate <NUM> includes a body <NUM> with a top surface <NUM> opposite a bottom surface <NUM>, and a first side <NUM> opposite a second side <NUM>. The plate <NUM> may be, for example, a three-dimensional misshapen parallelogram which may be rounded on the ends, bottom surface and at least one side. The length of the top surface <NUM> may be, for example, longer than the length of the bottom surface <NUM> forming tapered ends. The plate <NUM> may have a radius on the outer diameter of the first or medial side <NUM> to accommodate the spinal anatomy.

In one embodiment, for example, the first side <NUM> of the plate <NUM> may have approximately a <NUM> degree angle transitioning into a <NUM> radius, although other angles and radius dimensions are contemplated. The plate <NUM> may also be, for example, shaped to have a low profile to avoid bone and tissue impingement. In addition, the plate <NUM> may be, for example, generally symmetric, for example, when viewed from above as shown in <FIG>. The body <NUM> of the plate <NUM> may also have, for example, additional smoothing or rounded edges to accommodate a feature of a patient's anatomy while maintaining the necessary wall thickness in critical areas of the body <NUM> to maintain strength while reducing the incident of bone or tissue impingement.

As shown in <FIG>, <FIG>, the plate <NUM> may also contain a first channel <NUM> and a second channel <NUM>. The first channel <NUM> may extend through the body <NUM> from the top surface <NUM> to the bottom surface <NUM>. The second channel <NUM> may extend through the body <NUM> from the top surface <NUM> to the bottom surface <NUM>.

As shown in <FIG>, the first channel <NUM> may define a first axis or first trajectory T3, which when the plate <NUM> is attached to the lower portion of the insertion guide assembly <NUM> (<FIG>), the first trajectory T3 aligns with and is coaxial with the first trajectory T1 (<FIG>). The first channel <NUM> may include upper internal threads <NUM>, a conical seat <NUM>, a Morse tapered section <NUM>, and a lower cylindrical guide <NUM>.

As shown in <FIG>, the second channel <NUM> may define a second axis or second trajectory T4, which when the plate <NUM> is attached to the lower portion of the insertion guide assembly <NUM> (<FIG>), the first trajectory T4 aligns with and is coaxial the second trajectory T2 (<FIG>). The second channel <NUM> may include upper internal threads <NUM>, a conical seat <NUM>, a Morse tapered section <NUM> and a lower cylindrical guide <NUM>.

With reference again to <FIG>, the plate <NUM> may include the top surface <NUM> defining a partial raised boss <NUM> disposed around the first channel <NUM>. The plate <NUM> may include the top surface <NUM> defining a partial raised boss <NUM> disposed around the second channel <NUM>.

With reference to <FIG>, the plate <NUM> may include a center through-hole <NUM> such as counter sunk hole having an upper internally threaded portion <NUM> (<FIG>) and a lower smaller sized through-hole <NUM> (<FIG>). The threaded portion is sized to attach to the threaded distal end <NUM> (<FIG>) of the plate holder <NUM> (<FIG>). The smaller through-hole <NUM> is sized to receive the distal end <NUM> (<FIG>) of the docking pin <NUM> (<FIG>).

<FIG> illustrates the nesting of the upper portion and bosses of the plate <NUM> to lower portion <NUM> of insertion guide <NUM> with the distal end <NUM> threadably received in the threaded central opening <NUM> to secure the plate <NUM> to the insertion guide <NUM>. From the present disclosure, it will be appreciated that other plate and insertion guide configurations and/or securing mechanisms may be employed. In addition, the plate <NUM> and/or the insertion guide assembly <NUM> (<FIG>) may include markings or other indicia to aid a surgeon orienting the implant system <NUM> (<FIG>) visually or using fluoroscopy.

-With reference to <FIG>, a bone fusion system <NUM> may be, for example, a three piece construct including the plate <NUM>, a first fixation element <NUM>, and a second fixation element <NUM>. The fixation elements may be cannulated fasteners, fixation screws, bone screws, fixation members, fasteners, screws, pegs, pins, and the like as known by one of ordinary skill in the art. The fixation elements may be, for example smooth or threaded. The two fixation elements are configured or sized and shaped to provide a non-co-planar screw trajectory while allow for or achieving fusion. The plate <NUM> is sized and shaped or configured to assist or aid with the positioning of the two insertion guides as described above, and also with aiding and guiding the two fixation elements into a patient's vertebrae. For example, the plate <NUM> may be used to aid the guiding of the fixation elements into divergent aspects of the vertebrae and to lock the two divergent fixation elements into place. Specifically, the plate <NUM> may be used to aid in the guiding of a first fixation element into a patient's pedicle and a second fixation element into the patient's facet/pedicle of a vertebrae, or vice versa. In other embodiment, a bone fusion system for use with guide assembly <NUM> may be a five piece construct including a first set screw and a second set screw as described in greater detail below.

As described below, the fixation elements <NUM> may be guided by guide wires (not shown in <FIG>) and guided by the channels in the plate <NUM> and into the bone. The second fixation element <NUM> is implanted at the opposite angle from the first fixation element <NUM> and may be offset by a distance d1 such as to allow the screws to pass to their desired final position. The compound angle of the fixation elements generally forms a "V" shape, where the fixation elements are at opposing angles and where one fixation element may be medial or lateral to the opposite fixation element by a distance d2 between the centers of the fixation elements. The compound angle may be, for example, approximately <NUM>-<NUM> degrees. The two fixation elements that form the "V" shape are then securely locked into place in the plate <NUM>, thus locking the fixation elements to prevent rotation and axial displacement to secure the entire rigid construct.

As shown in <FIG>, the fixation element <NUM> may include an upper potion <NUM> having a taper <NUM> that matches the taper of the lower cylindrical guide <NUM> (<FIG>) of the first channel in the plate <NUM>. Once the fixation element <NUM> is implanted in a bone and the taper on the upper portion <NUM> of the fixation element <NUM> makes contact with the taper of the lower portion of the channel <NUM> (<FIG>) of the plate <NUM>, the taper of the fixation element <NUM> will lock to the plate. The taper may be between <NUM> degree and <NUM> degrees, or any suitable taper and form a Morse taper connection. Other connections such as snap fit connections (whether using snap rings or not), and the like may be suitably employed. The fixation element <NUM> may include a drive opening at an upper end for use in installation in plate <NUM> as shown in <FIG>. The second fixation element <NUM> (<FIG>) may be similarly attached to the implant <NUM>. The fixation elements may be curved at the distal ends.

<FIG> illustrate method (not claimed) steps for using implant system <NUM> (<FIG>) and a plate <NUM>, according to an embodiment of the present disclosure. Initially, the method may include operably assembling and attaching the plate <NUM> (<FIG>) to the insertion guide <NUM> (<FIG>) with the plate holder <NUM> (<FIG>) without the docking pin <NUM> (<FIG>). The table mount <NUM> (<FIG>) is mounted to the table and assembled insertion guide, plate holder, and plate may then be attached to the table mount <NUM> (<FIG>).

After determining an initial incision for the patient, for example, using lateral fluoroscopy, a midline skin incision is marked and made, the ipsilateral fascia is cut, and the paraspinal muscles are dissected from the spinous processes.

As shown in <FIG>, the assembled insertion guide <NUM>, plate holder <NUM>, and plate <NUM> is placed directly over the vertebrae or disc space intended to be stabilized. For example, the center portion <NUM> of the insertion guide <NUM> may be lined up over and placed into the incision or over the inferior endplate depending on the level and the patient's anatomy.

As shown in <FIG>, the docking pin <NUM> is inserted into the passageway in the plate holder <NUM>, and rotated so that the distal end of the docking pin <NUM> extends below the bottom of the plate <NUM> and is inserted into the lamina/facet for about <NUM> to about <NUM> millimeters (mm) as shown in <FIG>. For example, the docking pin <NUM> is rotated so that the distal end extends from the bottom of the plate <NUM> into the facet/lamina. Once the docking pin <NUM> is installed into the facet/lamina, using fluoroscopy the docking pin <NUM> is tilted and pointed, e.g., parallel to the inferior endplates. Incisions for cannulas <NUM> and <NUM> (e.g., Jamshidi-type needles) are made, and the cannulas <NUM> and <NUM> or drills may be inserted. Using fluoroscopy, the assembled insertion guide plate holder, and docking pin tilt is checked and re-pointed if necessary. e.g., parallel to inferior endplate, as shown in <FIG>. Using fluoroscopy, the height above the lamina/facet is adjusted, to optimize the trajectories T1 and T2 to match the patient anatomy, for example, by rotating pin device <NUM> or moving the insertion guide assembly, as shown in <FIG>. With reference to <FIG>, the table mount <NUM> (<FIG>) may be adjusted to angle or twist the implant system <NUM> to twist the caudal-aimed guide arm toward the midline ML and to aim both fixation elements such as screws toward the pedicles. For example, the insertion guide assembly is rotated to that the implant lines are parallel with the midline ML. Using fluoroscopy, the trajectories are verified in the sagittal plane.

As shown in <FIG>, a first K-wire <NUM> is inserted through the first cannula <NUM> and driven into the bone, a second K-wire <NUM> is inserted through the second cannula <NUM> and driven into the bone, and the trajectories of the K-wires is confirmed on the sagittal and AP view.

With reference to <FIG>, the cannulas <NUM> and <NUM> (<FIG>) are removed and then the insertion guide system is removed. For example, the docking pin <NUM> (<FIG>) is rotated, e.g., unthreaded, and removed from the plate holder <NUM>, and the plate holder <NUM> is rotated and disconnected from the plate <NUM>. Alternatively, the plate holder <NUM> (<FIG>) may be rotated, and removed along with the docking pin <NUM> (<FIG>). To remove the insertion guide, the K-wires are bent out of lateral slots in the insertion guide (outside and inside the incision). If bilateral fixation is desired, the process may be repeated to install a second set of guidewires.

With reference to <FIG> and <FIG>, pilot holes are drilled into the hard bone. A first cannulated facet/pedicle fixation element <NUM> (<FIG>) is slid over the first K-wire <NUM> and passed through the plate <NUM>. The first fixation element <NUM> (<FIG>) is then and driven into the bone, for example, the facet and pedicle, and confirming the placement with fluoroscopy. A second cannulated facet/pedicle fixation element <NUM> (<FIG>) is slide over the second K-wire <NUM> and passed through the plate <NUM>. The second fixation element <NUM> (<FIG>) is then and driven into the bone, for example, the facet and pedicle, and confirming the placement with fluoroscopy. For example, to advance the fixation elements to provisionally engage the plate and screw threads, alternate <NUM>/<NUM> turns between the first and second fixation elements until the heads of the fixation elements are seated in the plate. For hard bone, the threads of the fixation element may be cut.

With reference to <FIG>, the K-wires <NUM> and <NUM> (<FIG>) are removed and the fixation elements <NUM> are tightened with counter-torque. The plate and fixation elements are confirmed using A/P and lateral placement fluoroscopy. If desired, a surgeon can proceed to a contralateral side or an adjacent level with another plate and repeat the above process.

With reference to <FIG> therein is illustrated a surgical method (not claimed) <NUM>, which may include, for example, at <NUM> providing an implant assembly having a plate secured to an insertion guide, at <NUM> positioning the plate adjacent to an anatomical structure, and at <NUM> inserting a pin through the insertion guide and the plate, and into the anatomical structure. At <NUM> a first guide wire is inserted through the insertion guide and the plate along a first trajectory into the anatomical structure, at <NUM> a second guide wire is inserted through the insertion guide and the plate along a second trajectory into the anatomical structure. At <NUM> the insertion guide is removed from the plate and the inserted guide wires, at <NUM> a first fixation element is inserted over the first guide wire, through the plate, and into the anatomical structure, and at <NUM> a second fixation element is inserted over the second guide wire, through the plate, and into the anatomical structure. At <NUM>, the first guide wire and the second guide wire are removed from the anatomical structure so that the plate and the first and second fixation element form a bone fusion system in the anatomical structure. In other embodiments, the method <NUM> may include inserting cannulas through the insertion guides, and inserting the guide wires through the cannulas.

<FIG> illustrates another midline incision implant system <NUM>, according to an embodiment of the present disclosure. The midline incision implant system <NUM> may be operably attachable to a table mount. In this illustrated embodiment, the midline incision implant system <NUM> may generally include the insertion guide assembly <NUM> having, for example, an insertion guide <NUM>, a plate holder <NUM>, a docking pin <NUM>, and a support <NUM>. The midline incision implant system <NUM> may be used in the surgical method <NUM> (<FIG>) described above to install the plate <NUM> along with fixation elements in the patient.

<FIG> illustrates another midline incision implant system <NUM>, according to an embodiment of the present disclosure. The midline incision implant system <NUM> may be operably attachable to a table mount. In this illustrated embodiment, the midline incision implant system <NUM> may be essentially the same as midline incision implant system <NUM> (<FIG>). For example, midline incision implant system <NUM> may generally include an insertion guide assembly <NUM> having, for example, an insertion guide <NUM>, a plate holder <NUM>, a docking pin <NUM>, and a handle <NUM>.

In this embodiment, the plate <NUM> itself provides the guide holes for use in forming the first trajectory T1 and the second trajectory T2. For example, a lower portion may have a plate engaging surface that is operable to align the plate <NUM>, e.g., recesses for receiving portions of the bosses of the plate <NUM>, so that the channels in plate <NUM> are disposed in proper relation to the guide holes in an upper portion <NUM> for forming first trajectory T1 and second trajectory T2. For example, the lower portion <NUM> need not include guide holes in this illustrated embodiment. It will be appreciated that other configurations of the lower portion of the alignment guide and the plate may be employed for aligning the plate to the insertion guide, for example, aligned detents, projections, recesses, or other suitable features. The midline incision implant system <NUM> may be used in the surgical method <NUM> (<FIG>) described above.

Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to <FIG>, there is illustrated an exemplary embodiment of the implant system <NUM>, which may include the first insertion guide <NUM>, the second insertion guide <NUM>, and plate <NUM> according to the present disclosure. The insertion guides <NUM> and <NUM> of the implant system <NUM> may be secured to the plate <NUM> during a surgical procedure to establish fixation element trajectories above a surgical incision. As described in greater detail below, and as shown in <FIG>, the plate <NUM> in addition to aiding guidance for providing fixation element trajectories, the plate <NUM> may be operable in a bone fusion system <NUM> for use in connection with a first plate fixation element <NUM> and second plate fixation element <NUM> to maintain or re-establish proper spacing and alignment within a patients spine.

With reference again to <FIG>, the first insertion guide <NUM> may include, for example, a generally cylindrical hollow body <NUM> such as a cylindrical hollow elongated body having an upper end portion <NUM> and a lower end portion <NUM>. The lower end portion <NUM> is operably attachable to the plate <NUM> as described below.

With reference to <FIG>, the first insertion guide <NUM> may include, for example, a first passageway <NUM> having an axis A1 extending therethrough. The first passageway <NUM> has a first opening <NUM> opening onto the end portion <NUM> of the body <NUM>, and a lower opening <NUM> opening onto the second end portion <NUM> of the body <NUM>. The first passageway <NUM> may be a generally constant cylindrical passageway having a constant diameter D1. The upper end of the first passageway <NUM> may be countersunk having an upper enlarged opening that tapers to the constant diameter. The first passageway <NUM> may also extend, for example, generally parallel to the outer cylindrical surface of the first insertion guide <NUM>. Alternative outer surfaces of the insertion guides may be employed other than cylindrical and are also contemplated including, for example, outer cross-sectional surfaces that are square, rectangular, polygonal, non-symmetric, or other shapes, and combination thereof.

The upper end portion <NUM> of the first insertion guide <NUM> may have an outer knurled surface <NUM> as best shown in <FIG>. With reference again to <FIG>, the lower end portion <NUM> of the first insertion guide <NUM> may have an outer cylindrical stop <NUM>, outer threads <NUM>, and a reduced size projection <NUM>. For example, the outer cylindrical surface may have a diameter D2, and the projection <NUM> may have an outer cylindrical surface having a diameter D3 sized smaller than diameter D2. As described in greater detail below, the insertion guides are releasably attachable to the plate <NUM> (<FIG>).

With reference again to <FIG>, in some embodiments, the second insertion guide <NUM> may be, for example, the same as the first insertion guide <NUM>. It will be appreciated the length, size of the passageway, the size of overall outer cylindrical surface may be appropriated selected. In other embodiments, the first and second insertion guides employed in the plate system may be sized and configured differently, e.g., having different sized passageways, having different outer cylindrical surfaces, and/or having different overall lengths. In some embodiments, an insertion guide may have a length of about <NUM> (<NUM> inches), an outer cross-sectional diameter of about <NUM> (. <NUM> inches), and an internal passageway cross-sectional diameter of about <NUM> (. <NUM> inches). The first and second insertion guides <NUM>, <NUM> may be various lengths to accommodate a patient.

As shown in <FIG>, the plate <NUM> may also include at least one lateral side indicator <NUM>. The at least one lateral side indicator <NUM> may be, for example, at least one protrusion, extension or a like feature extending away from a side of the body <NUM> or alternatively, a slot, recess, grooves, machine marking or a like feature inset into the side of the body <NUM>, to indicate the lateral side of the plate <NUM> and e.g., a visual reference point for determining the position of the plate <NUM>. Further, the at least one lateral side indicator <NUM> may further designate whether the plate <NUM> is a left or right plate. The at least one lateral side indicator <NUM> may provide, for example, a point of reference for the surgeon for the position or location of the plate <NUM>. The plate <NUM> may include a center hole <NUM> such as an internally threaded hole. In some embodiments, a plate may not include a center hole or may include a center hole not having internal threads.

Referring now to <FIG>, the plate <NUM> includes a body <NUM> with a top surface <NUM> opposite a bottom surface <NUM>, and a first side <NUM> opposite a second side <NUM>. The plate <NUM> may be, for example, a three-dimensional misshapen parallelogram which may be rounded on the ends, bottom surface and at least one side. The length of the top surface <NUM> may be, for example, longer than the length of the bottom surface <NUM> forming tapered ends. The plate <NUM> may have a radius on the outer diameter of the first or medial side <NUM> to accommodate the spinal anatomy. In one embodiment, for example, the first side <NUM> of the plate <NUM> may have approximately a <NUM> degree angle transitioning into a <NUM> radius, although other angles and radius dimensions are contemplated. The plate <NUM> may also be, for example, shaped to have a low profile to avoid bone and tissue impingement. In addition, the plate <NUM> may be, for example, generally symmetric, for example, when viewed from above as shown in <FIG>. The body <NUM> of the plate <NUM> may also have, for example, additional smoothing or rounded edges to accommodate a feature of a patient's anatomy while maintaining the necessary wall thickness in critical areas of the body <NUM> to maintain strength while reducing the incident of bone or tissue impingement.

As shown in <FIG>, <FIG>, <FIG>, the plate <NUM> may also contain a first channel <NUM> and a second channel <NUM>. The first channel <NUM> may extend through the body <NUM> from the top surface <NUM> to the bottom surface <NUM>. The second channel <NUM> may extend through the body <NUM> from the top surface <NUM> to the bottom surface <NUM>.

As best shown in <FIG>, the first channel <NUM> may define a first axis or first trajectory T1. The first channel <NUM> may include upper internal threads <NUM>, a conical seat <NUM>, and a lower cylindrical guide <NUM>. As best shown in <FIG>, the second channel <NUM> may define a second axis or second trajectory T2. The second channel <NUM> may include upper internal threads <NUM>, a conical seat <NUM>, and a lower cylindrical guide <NUM>. The first channel <NUM> (<FIG>) may receive the lower end portion <NUM> (<FIG>) of first insertion guide <NUM> (<FIG>). The second channel <NUM> may receive the lower end portion <NUM> of the second insertion guide <NUM>.

With reference again to <FIG>, when first insertion guide <NUM> is operably connected to plate <NUM>, axis A1 of the passageway <NUM> of the first insertion guide <NUM> is aligned with the first trajectory T1, which may be angled in a first direction. With reference again to <FIG>, when the second insertion guide <NUM> is operably connected to the plate <NUM>, the axis A2 of the second passageway <NUM> of the second insertion guide <NUM> is aligned with the second trajectory T2, which may be angled in a second direction. The second direction of the second passageway <NUM> may be opposite the first direction of the first passageway <NUM>. The first and second trajectories may be positioned to extend past each other to allow for guiding a Jamshidi needle, k-wire, screw, or the like through the insertion guides into the trajectory into, for example, the divergent aspect of the vertebrae. For example, the first trajectory T1 may be oriented, for example, on the cephalad end for guiding a Jamshidi needle, k-wire, screw, or the like into the cephalad to caudal trajectory for placement in the pedicle. The second trajectory T2 may be oriented, for example, on the caudal end for guiding a Jamshidi needle, k-wire, screw, or the like into the desired caudal to cephalad facet/pedicle trajectory. In one embodiment, for example, the facet/pedicle trajectory extends along the first passageway A1 and moves in a caudal direction and the pedicle trajectory enters in the second passageway A2 and moves in a cephalad direction.

As described below, once the insertion guides are removed, the alignment and insertion of fixation may be made in a crossed or X-shaped arrangement as described below.

With reference to <FIG>, a bone fusion system <NUM> may be, for example, a five piece construct including the plate <NUM>, a first fixation element <NUM>, the second fixation element <NUM>, a first set screw <NUM>, and a second set screw <NUM>. The fixation elements may be cannulated fasteners, fixation screws, bone screws, fixation members, fasteners, screws, pegs, pins, and the like as known by one of ordinary skill in the art. The fixation elements may be, for example smooth or threaded. The two fixation elements are configured or sized and shaped to provide a non-co-planar screw trajectory while allow for or achieving fusion. The plate <NUM> is sized and shaped or configured to assist or aid with the positioning of the two insertion guides as described above, and also with aiding and guiding the two fixation elements into a patient's vertebrae. For example, the plate <NUM> may be used to aid the guiding of the fixation elements into divergent aspects of the vertebrae and to lock the two divergent fixation elements into place. Specifically, the plate <NUM> may be used to aid in the guiding of a first fixation element into a patient's pedicle and a second fixation element into the patient's facet/pedicle of a vertebrae, or vice versa.

With reference still to <FIG>, the bone fusion system <NUM> may include the first set screw <NUM> and the second set screw <NUM>. First set screw <NUM> may be, for example, sized and shaped or configured to be receive in the threaded portion of the channel <NUM>. Second set screw <NUM> may be, for example, sized and shaped or configured to be receive in the threaded portion of the channel <NUM>. The first set screw <NUM> may be used to place pressure on first fixation element <NUM> inserted through the channel <NUM> and the second set screw <NUM> may be used to place pressure on the second fixation element <NUM> inserted through the channel <NUM> and into the facet/pedicle and/or pedicle, thereby securing or locking the bone fusion device.

First set screw <NUM> may include a threaded body, and may also include a drive opening at a first end and an engagement protrusion (not shown) at a second end. The drive opening may be, for example, hexagonal, square, Phillips or another multi-lobed configuration for coupling with an insertion instrument. The engagement protrusion may be tapered as the engagement protrusion extends away from the threaded portion of the threaded body. Second set screw <NUM> may be similarly configured.

As shown in <FIG>, the first fixation element <NUM> may include an upper potion <NUM> having a taper <NUM> that matches the taper of the lower cylindrical guide <NUM> (<FIG>) of the first channel <NUM> in the plate <NUM>. Once the first fixation element <NUM> is implanted in a bone and the taper on the upper portion <NUM> of the first fixation element <NUM> makes contact with the taper of the lower portion of the first channel <NUM> of the plate <NUM>, the taper of the first fixation element <NUM> will lock to the plate. The taper may be between <NUM> degree and <NUM> degrees, or any suitable taper and form a Morse taper connection. Other connections such as snap fit connections (whether using snap rings or not), and the like may be suitably employed. The first fixation element <NUM> may include a drive opening at an upper end for use in installation in plate <NUM> as shown in <FIG>. The second fixation element <NUM> may be similarly attached to the plate <NUM>. <FIG> illustrates another embodiment of a fixation element <NUM> having a tapered portion <NUM> and a threaded portion <NUM>. The threaded portion <NUM> may be readily engageable with the internal threads of the implant channels.

<FIG> illustrate a method (not claimed) of using implant system <NUM> (<FIG> and <FIG>) which may include operably assembling and attaching first insertion guide <NUM> to plate <NUM>. After determining an initial incision using lateral fluoroscopy, an appropriate caudal incision is made to enable dissection of the plate through the muscle so that plate <NUM> may be placed onto the lamina/facet directly over the vertebrae <NUM> or disc space, e.g., using the first insertion guide <NUM> to rock and slide the plate <NUM> in the direction of arrow F under the soft tissue, as shown in <FIG>. Using lateral fluoroscopy, a second incision is made to enable inserting the cephalad or second insertion guide <NUM> toward the plate so that the lower end of the second insertion guide <NUM> is insertable into in cephalad channel <NUM> (<FIG>) and operably attachable to the plate <NUM> as shown in <FIG>. Using lateral fluoroscopy, the position of insertion assembly <NUM> is checked. With reference to <FIG>, a first Jamshidi (not shown) is tapped in lightly through first insertion guide <NUM> and a second Jamshidi (not shown) is tapped in lightly through second insertion guide <NUM>, and check the lateral position. Implant system <NUM> is moved back and forth with the two Jamshidis to a desired position and confirmed with lateral flouro, i.e., position the plate <NUM> over the disc space and almost resting on the lamina. Once the positioned is confirmed with the lateral flouro, further confirmation is made with AP fluoro to ensure the trajectories are going to engage the pedicles. The optional, empty center hole <NUM> (<FIG>) in the plate is helpful for visualization during imaging.

The method may then include removing the Jamshidi needle stylets when the correct position is achieved. With reference still to <FIG>, the method may further include inserting k-wires <NUM> through the insertion guides and confirming the desired k-wire <NUM> placement with fluoroscopy. Next, the method may include removing the insertion guides <NUM> and <NUM> from the plate <NUM> and the k-wires <NUM> leaving the plate <NUM> and k-wires <NUM> in place within the patient. Then, the method may include sliding a cannulated facet/pedicle fixation element over the facet/pedicle k-wire, driving the facet/pedicle fixation element into the bone, for example, the facet and pedicle, and confirming the placement with fluoroscopy. The method may also include sliding a cannulated fixation element over the k-wire, driving the pedicle fixation element into the pedicle, and confirming the placement with fluoroscopy. Next, the method may include removing the k-wires and inserting the set screw <NUM>, <NUM> until the set screw pushes the facet/pedicle and pedicle fixation elements slightly. Finally, the method may include confirming the correct placement of the bone fusion device with fluoroscopy. The above method may be performed by a surgeon by suitably grasping and positioning the insertion guides and plate relative to the patient's vertebrae during the above steps.

As shown in <FIG>, a handle member <NUM> may be operably attached to implant system <NUM>. The handle member <NUM> may include a rod or shaft <NUM> with a distal end <NUM> and a proximal end <NUM>. The distal end <NUM> may be configured or sized and shaped to engage the plate <NUM>. The proximal end <NUM> may be configured or sized and shaped to couple to a handle <NUM>. The distal end <NUM> may be threaded and receivable in an internally threaded opening <NUM> (<FIG>) disposed along the top surface <NUM> between the first channel <NUM> and the second channel <NUM>. It will be appreciated that in another embodiments, a handle member may have a passageway therethrough that is operable for receiving a docking pin as described above.

Another method (not claimed) of using implant system <NUM> may include, for example, making a mid-line incision large enough for portions of the pre-assembled plate <NUM> and the insertions guides <NUM> and <NUM> to fit as it is placed along the vertebrae <NUM>. The plate <NUM> may be coupled to the handle member <NUM>. Next, the method may include placing the implant system <NUM> and positioning the plate <NUM> on the appropriate side of the vertebrae <NUM>, as shown in <FIG>. The method may also include inserting a first Jamshidi needle (not shown) through the first passageway in first insertion guide <NUM> and confirming the Jamshidi needle placement using fluoroscopy. The method may further include inserting a second Jamshidi needle (not shown) through the second passageway in the second insertion guide <NUM> and confirming the Jamshidi needle placement using fluoroscopy. Next, the method may include confirming the trajectories of both Jamshidi needles with anteroposterior (AP) and lateral fluoroscopy. Then, the method may include removing the Jamshidi needle stylets when the correct position is achieved. The method may further include inserting k-wires <NUM> through the insertion guides <NUM>, <NUM> and confirming the desired k-wire <NUM> placement with fluoroscopy. Next, the method may include removing the insertion guides <NUM>, <NUM> and disengaging the insertion guides <NUM>, <NUM> from the k-wires <NUM> and the plate <NUM> leaving the plate <NUM> and k-wires <NUM> in place within the patient. Then, the method may include sliding a cannulated facet/pedicle fixation element over the facet/pedicle k-wire, driving the facet/pedicle fixation element into the bone, for example, the facet and pedicle, and confirming the placement with fluoroscopy. The method may also include sliding a cannulated fixation element over the k-wire, driving the pedicle fixation element into the pedicle, and confirming the placement with fluoroscopy. Next, the method may include removing the k-wires and inserting the set screw <NUM>, <NUM> (<FIG>) until the set screw pushes the facet/pedicle and pedicle fixation elements slightly. Finally, the method may include confirming the correct placement of the bone fusion device with fluoroscopy.

<FIG> and <FIG> illustrates the implant system <NUM> supported by a support assembly <NUM> in accordance with an embodiment of the present disclosure. The support assembly <NUM> may allow a surgeon to operably fixedly position the assembled implant system <NUM>, e.g., the assembled insertion guides <NUM>, <NUM> (<FIG>) and plate <NUM> (<FIG>), relative to the patient's vertebrae <NUM> during the above method steps. For example, as best shown in <FIG>, the support assembly <NUM> may include a table mount <NUM>, a plurality of connection rods <NUM>, <NUM>, and <NUM>, a plurality of movable joints <NUM>, <NUM>, <NUM>, and <NUM>, and an arm assembly <NUM>. The table mount may be fixedly secured to a suitable structure fixed relative to a patient. As best shown in <FIG>, arm assembly <NUM> may include a first arm <NUM> and a second arm <NUM> that are disposed in a fixed orientation relative to each other. Attached to the distal end of the first arm <NUM> is a first guide connector <NUM>. Attached to the distal end of the second arm <NUM> is a second guide connector <NUM>. The guide connectors may have suitable passageways for receiving the first insertion guide <NUM> and the second insertion guide. The combination of the arm assembly and the assembled implant system <NUM> form a fixed structure that may be fixedly positioned relative to the patient during the various method steps noted above.

The bone fixation element insertion angle may be, for example, predetermined by the plate <NUM> and targets the fixation element trajectory via channels in the plate. The fixation elements are implanted in such a fashion as to accomplish a non co-planer, axial divergent fixation element trajectory.

With reference again to <FIG>, in an embodiment, the first fixation element <NUM> will be guided by the plate <NUM> and secured into bone through one of the through hole features or guide holes. The second fixation element <NUM> is implanted at the opposite angle through one of the guide holes in the plate <NUM> and may be offset by a distance d1 such as to allow the screws to pass to their desired final position. The compound angle of the fixation elements generally forms a "V" shape, where the fixation elements are at opposing angles and where one fixation element may be medial or lateral to the opposite fixation element by a distance d2 of the diameter of the fixation element. The compound angle may be, for example, approximately <NUM>-<NUM> degrees. The two fixation elements that form the "V" shape are then securely locked into place by the set screws that are tightened until contact is made with each fixation element, thus locking the fixation elements to prevent rotation and axial displacement to secure the entire rigid construct.

The plate <NUM> itself is not fixed to bone. The plate <NUM>, two fixation elements and set screws form a construct, which construct is fixed to bone via the fixation elements.

The implant guide channels for fixation element delivery are positioned at an optimum insertion based on anatomical and surgical data. The guide channels may be sized to be slightly larger than the outer diameter of the screws. The plates of the present disclosure may be configured as a right or left plate.

The medial aspect of the plate <NUM> is configured to enable insertion with respect to the anatomy of the spinous process and the radial transition into the lamina.

While the plate <NUM> as described above for fixation using one facet and one pedicle location, this is an exemplary embodiment. The plate <NUM> could also be used to fix or span different anatomic locations of bone fracture segments to facilitate a surgical correction, fracture healing or bone fusion. While the descriptions utilized are for screw fixation, the fixation elements could be, for example, smooth rods, splined or fluted rods, pins, or a combination of the elements described above, as would be known by one of ordinary skill in the art.

<FIG> is a perspective view of a midline incision implant system <NUM>, according to an embodiment of the present disclosure. For example, a surgeon may be operable using the plate <NUM> and a pair of cannulas to align and position the implant system <NUM> in a proper location and orientation for use in installing the fixation elements and forming a bone fusion system as described below in connection a surgical method (not claimed) <NUM> illustrated in <FIG> below. In this illustrated embodiment, such an implant system and method need not employ an insertion guide assembly, and instead rely on the surgeon and the plate for providing the proper location, alignment, and/or orientation of the plate and the fixation element.

As shown in <FIG>, therein illustrated is the surgical method <NUM>, according to an embodiment of the present disclosure. For example, the method <NUM> may include at <NUM> providing a plate having a first surface and a second surface, a first opening at a first end of the body extending from the first surface to the second surface and the first opening defining a first trajectory, a second opening at a first end of the body extending from the first surface to the second surface and the second opening defining a second trajectory, and the first trajectory extends at an angle opposite a direction of the second trajectory. At <NUM>, the plate is positioned adjacent to an anatomical structure, and at <NUM> a first cannula is inserted through the first opening of the plate and into the anatomical structure, and a second cannula is inserted through the second opening of the plate and into the anatomical structure. At <NUM>, the placement of the plate, the first cannula, and the second cannula are verified relative to the anatomical structure. At <NUM>, a first guide wire is inserted through the first cannula and into the anatomical structure, and a second guide wire is inserted through the second cannula and into the anatomical structure. At <NUM>, the first cannula is removed from the first guide wire, and the second cannula is removed from the second guide wire. At <NUM>, a first fixation element is inserted over the first guide wire, through the plate, and into the anatomical structure, and a second fixation element is inserted over the second guide wire, through the plate, and into the anatomical structure. At <NUM>, the first guide wire and the second guide wire are removed from the anatomical structure so that the plate and the first and second fixation element form a bone fusion system in the anatomical structure.

The present disclosure may be operable in connection with an expandable interbody fusion system.

In the various embodiments, the insertion guides may be formed from a biocompatible polymeric or metallic, or combinations thereof. The insertion guides may be a one-piece or monolithic structure. The plate and fixation elements may be formed from a metallic or other suitable material. The insertion guides and the plates may include marking or other indicia for allowing a surgeon to visually align or reposition the insertion guide and/or plate, and/or or using fluoroscopy align or reposition the insertion guide and/or plate.

As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present disclosure without departing from the scope of the disclosure. The plates, screws, and other components of the devices and/or systems as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the devices and systems may include more or fewer components or features than the embodiments as described and illustrated herein. Accordingly, this detailed description of the currently-preferred embodiments is to be taken as illustrative, as opposed to limiting the present disclosure.

Claim 1:
A plate (<NUM>), configurated to be implanted in an anatomical structure, comprising:
a body (<NUM>) comprising:
a first surface (<NUM>) and a second surface (<NUM>);
a first opening (<NUM>) at a first end of the body (<NUM>) extending from the first surface (<NUM>) to the second surface (<NUM>);
a second opening (<NUM>) at a second end of the body (<NUM>) extending from the first surface (<NUM>) to the second surface (<NUM>);
a third opening (<NUM>) positioned between the first opening (<NUM>) and the second opening (<NUM>) and extending from the first surface (<NUM>) to the second surface (<NUM>);
the first surface (<NUM>) defining a first boss (<NUM>) extending around at least a portion of the first opening (<NUM>) and wherein the first boss (<NUM>) extends away from the first surface (<NUM>); and
the first surface (<NUM>) defining a second boss (<NUM>) extending around at least a portion of the second opening (<NUM>) and wherein the second boss (<NUM>) extends away from the first surface (<NUM>).