Patent Description:
The present invention relates generally to general surgery, orthopaedic and neurosurgical implants used for insertion within a patient's vertebrae. More specifically, but not exclusively, the present invention concerns bone fusion devices, systems and instruments.

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>-<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> and <CIT> disclose bone fusion implant system with a drill guide and an implant engaging mechanism.

Aspects of the present invention provide bone fusion devices, systems and instruments. The methods and procedures disclosed herein do not form part of the presently claimed invention, but are useful in understanding the implementation, usefulness and advantages of the presently claimed invention.

According to the invention provided herein is a bone fusion implant system as set forth in claim <NUM>. The implant including a body with a first hole at a first end of the body, a second hole at a second end of the body, and a locking opening positioned between the first hole and the second hole.

These, and other objects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention 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 invention and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the invention.

Generally stated, disclosed herein are bone fusion systems, implants, devices and instruments. Further, surgical methods not forming part of the presently claimed invention for inserting the implants are discussed.

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.

Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current devices and methods are described herein with reference to use with the bones of the spine, the bones of the spine may be used to describe the surfaces, positions, directions or orientations of the devices, instrumentation and methods. Further, the devices and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the device and methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the scope of the invention. For example, the devices and methods, and the aspects, components, features and the like thereof, described herein with respect to a right side of the spine may be mirrored so that they likewise function with a left side of the spine and vice versa.

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>, there is illustrated an exemplary embodiment of an implant system <NUM>. The implant system <NUM> may include an insertion guide or cross bar guide tower <NUM>, a locking block <NUM>, and an implant <NUM>, as shown in <FIG>. The insertion guide <NUM> may include, for example, a base member or top block <NUM>, a coupling portion <NUM>, and a connecting member <NUM> coupled to the base member <NUM> at a first end and the coupling portion <NUM> at a second end, as shown in <FIG>, <FIG> and <FIG>. The insertion guide <NUM> and locking block <NUM> of the implant system <NUM> may be secured to the implant <NUM> during a surgical procedure to provide additional screw trajectory guidance from above the surgical incision.

Referring now to <FIG> and <FIG>, the insertion guide <NUM> may include a base member or top block <NUM> with a top surface <NUM> opposite a bottom surface <NUM>. The base member <NUM> may also include a first opening <NUM> at a first end, a second opening <NUM> at a second end, and a through hole <NUM> positioned between the first opening <NUM> and the second opening <NUM>. The first opening <NUM> may extend through the base member <NUM> from the top surface <NUM> to the bottom surface <NUM>. The first opening <NUM> may have, for example, a first trajectory which may be angled in a first direction. The first opening <NUM> may also extend, for example, parallel to the angled first end of the base member <NUM>. The second opening <NUM> may extend through the base member <NUM> from the top surface <NUM> to the bottom surface <NUM>. The second opening <NUM> may have, for example, a second trajectory which may be angled in a second direction. The second direction of the second opening <NUM> may be opposite the first direction of the first opening <NUM>. The first and second trajectories may be positioned to extend past each other to allow for the insertion of fasteners or screws (not shown) in a crossed or X-shaped arrangement. The second opening <NUM> may also extend, for example, parallel to the angled second end of the base member <NUM>. The openings or guide wire through holes <NUM>, <NUM> may be used to aid in alignment of the insertion guide or construct <NUM>. In an alternative embodiment, the base member <NUM> may include slots or slot features (not shown in <FIG> or <NUM>-<NUM>) extending into the openings <NUM>, <NUM> in the cross bar guide or insertion guide <NUM>. The slots or slot features (not shown) allow for the insertion guide or tower <NUM> to be separated from the implant, for example, implant <NUM>, by releasing the guide wire (not shown).

The through hole <NUM> may extend through the base member <NUM> from the top surface <NUM> to the bottom surface <NUM>. The through hole <NUM> may extend, for example, through the base member <NUM> perpendicular to the top and bottom surfaces <NUM>, <NUM>. As shown in <FIG> and <NUM>-<NUM>, the base member <NUM> may also include at least one hole <NUM>. The at least one hole <NUM> may extend between the sides of the base member <NUM>, for example, relatively perpendicular to the through hole <NUM> and relatively parallel to the top and bottom surfaces <NUM>, <NUM>. The at least one hole <NUM> may provide, for example, a point of reference for the surgeon for the position or location of the openings <NUM>, <NUM>. For example, the lateral holes <NUM> may align with the top surface or entrance to the openings <NUM>, <NUM> and the medial holes <NUM> may align with the bottom surface or exit of the openings <NUM>, <NUM>. Although the at least one hole <NUM> is shown as through holes, it is also contemplated that the holes <NUM> may be recesses, grooves, machine markings, and the like to provide a point of reference for the surgeon. Further, the openings <NUM> may receive a pin to provide additional visual reference point for determining the position of the locking block <NUM> and implant <NUM>. The top surface <NUM> may have, for example, a length larger than the length of the bottom surface <NUM>. The base member <NUM> may have, for example, a generally trapezoidal cross-sectional shape forming, for example, a trapezoidal prism. Alternative polygonal shapes are also contemplated including, for example, at least, rectangles, parallelograms, and the like.

As shown in <FIG>, <FIG> and <FIG>, the connecting member <NUM> may have a first end and a second end. The first end of the connecting member <NUM> may be coupled to the base member <NUM> and aligned with the through hole <NUM>. The second end of the connecting member <NUM> may be coupled to the coupling portion <NUM>. The through hole <NUM> continues through the connecting member <NUM> and the coupling portion <NUM> and is configured to receive a handle member (not shown). The handle member (not shown) may be similar to the handle member <NUM>, as described in greater detail below with reference to <FIG>, including a gripping portion and an at least partially threaded rod for engaging an implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> for insertion into a patient.

The coupling portion <NUM> may include a top surface <NUM> opposite a bottom surface <NUM> and a first side <NUM> opposite a second side <NUM>, as shown in at least <FIG>. The coupling portion <NUM> may also include a first opening <NUM> positioned at a first end and a second opening <NUM> at a second end. The first and second openings <NUM>, <NUM> may extend between the top surface <NUM> and the bottom surface <NUM>. The first and second openings <NUM>, <NUM> may also extend, for example, generally perpendicular to the top and bottom surfaces <NUM>, <NUM>. The first opening <NUM> may be, for example, offset or angled in a first direction relative to a longitudinal axis of the base member <NUM>, as shown in <FIG>. The second opening <NUM> may be, for example, offset or angled in a second direction relative to a longitudinal axis of the base member <NUM>, as also shown in <FIG>. The first and second openings <NUM>, <NUM> may be sized and shaped or configured to receive a fastener or fastening mechanism (not shown) to secure the locking block <NUM> to the coupling portion <NUM>, as shown in <FIG>. The sides <NUM>, <NUM> of the coupling portion <NUM> may be, for example, curved or slightly "S" shaped as shown in <FIG>. The coupling portion <NUM> may be, for example, angled relative to the longitudinal axis of the base member <NUM>.

As shown in <FIG>, <FIG>, and <FIG>, the locking block <NUM> includes a top surface <NUM> opposite a bottom surface <NUM>. The locking block <NUM> may include a first opening <NUM> at a first end and a second opening <NUM> at a second end. The first and second openings <NUM>, <NUM> may extend from the top surface <NUM> to the bottom surface <NUM>. The locking block <NUM> may also include a slot <NUM> extending from the exterior surface at the first end into the first opening <NUM> and from the top surface <NUM> to the bottom surface <NUM>, as shown in <FIG>, <FIG>, <FIG>, <FIG> and <FIG>. The first opening <NUM> may also extend, for example, parallel to the angled first end of the locking block <NUM>. The first opening <NUM> may have, for example, a first trajectory which may be angled in a first direction. The first trajectory of the locking block <NUM> may, for example, correspond to the first trajectory of the base member <NUM> to allow for a Jamshidi needle, k-wire, screw, or the like to be inserted through the first opening <NUM> of the base member <NUM> and the first opening <NUM> of the locking block <NUM>. The second opening <NUM> may also extend, for example, parallel to the angled second end of the locking block <NUM>. The second opening <NUM> may have, for example, a second trajectory which may be angled in a second direction. The second trajectory of the locking block <NUM> may, for example, correspond to the second trajectory of the base member <NUM> to allow for a Jamshidi needle, k-wire, screw, or the like to be inserted through the second opening <NUM> of the base member <NUM> and the second opening <NUM> of the locking block <NUM>. 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>, <NUM> may be, for example, angled approximately <NUM>-<NUM> degrees from a top surface <NUM> of the locking block <NUM>, however, additional angles are also contemplated to correspond to variations in patient anatomy.

With continued reference to <FIG>, <FIG>, <FIG>, and <FIG>, the locking block <NUM> may also include a center opening or through hole <NUM>. The through hole <NUM> is configured to allow a handle member (not shown) to pass through the locking block <NUM> and engage an implant, for example, the implant <NUM>. The through hole <NUM> may extend, for example, through the locking block <NUM> generally perpendicular to the top and bottom surfaces <NUM>, <NUM>. The locking block <NUM> may further include an alignment member <NUM> positioned on a side of the locking block <NUM>, as shown in <FIG>, <FIG> and <FIG>. The alignment member <NUM> may include at least one extension member <NUM> extending from the alignment member <NUM> past the bottom surface <NUM> of the locking block <NUM>, as shown in <FIG>. The at least one extensions member <NUM> may be, for example, multiple fork extensions. The at least one extension member <NUM> may be used to accurately locate the lateral aspect of the insertion guide or device <NUM>.

The locking block <NUM> may also include at least one securement opening <NUM>, <NUM> extending into a top surface <NUM> of the locking block <NUM>, as shown in <FIG> and <FIG>. The at least one securement opening <NUM>, <NUM> may be, for example, a first securement opening <NUM> and a second securement opening <NUM>. As shown in <FIG> and <FIG>, the first securement opening <NUM> may be positioned, for example, between the first opening <NUM> and the center opening <NUM>. The first securement opening <NUM> may also be positioned on the locking block <NUM> to align with the first opening <NUM> of the coupling portion <NUM> to receive a fastener or fastener member (not shown) and secure the locking block <NUM> to the coupling portion <NUM>, as shown in <FIG>. The second securement opening <NUM> may be positioned, for example, between the second opening <NUM> and the center opening <NUM>. The second securement opening <NUM> may also be positioned on the locking block <NUM> to align with the second opening <NUM> of the coupling portion <NUM> to receive a fastener or fastener member (not shown) and secure the locking block <NUM> to the coupling portion <NUM>, as shown in <FIG>.

The cross bar guide tower or insertion guide <NUM> may couple to the connector device or implant <NUM> while placing the trajectory devices (not shown) or fixation device insertion instruments (not shown), for example, a Jamshidi needle or k-wires. The top block or base member <NUM> of the instrument <NUM> incorporates guide holes or openings <NUM>, <NUM> to facilitate the insertion of a guide device (not shown) which may be, for example, a Jamshidi needle or similar device to aid in the delivery of a guide wire for subsequent surgical activities including passing the fixation members, bone screws, fasteners, pegs, pins, and/or springs through the locking block <NUM> to their final position.

A bone fusion device may be, for example, a four piece construct including an implant or connector device <NUM>, as shown in <FIG>, two cannulated fasteners, fixation screws, bone screws, fixation members, fasteners, pegs, pins, and/or springs (not shown), and a central locking screw <NUM>, <NUM>, as shown in <FIG>. The two cannulated bone screws and central locking screw <NUM>, <NUM> are configured or sized and shaped to provide a non-co-planar screw trajectory while allow for or achieving fusion. The implant <NUM> is sized and shaped or configured to assist with guiding the two screws into a patient's vertebrae. For example, the implant <NUM> may be used to guide the fixation screws (not shown) into divergent aspects of the vertebrae and to lock the two divergent screws or other fasteners into place. Specifically, the implant <NUM> may be used to guide a first fastener into a patient's pedicle and a second fastener into the patient's facet/pedicle of a vertebrae, or vice versa.

Referring now to <FIG>, <FIG>, and <FIG>, the implant or connector device <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 implant <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> is longer than the length of the bottom surface <NUM> forming tapered ends. The implant <NUM> may have a radius on the outer diameter of the first or medial side <NUM> to accommodate the spinous process. In one embodiment, for example, the first side <NUM> of the implant <NUM> may have approximately a <NUM> degree angle transitioning into a <NUM> radius, although other angles and radius dimensions are contemplated. The implant <NUM> may also be, for example, shaped to have a low profile to avoid bone and tissue impingement. In addition, the implant <NUM> may be, for example, slightly thicker on the second or lateral outer side <NUM> and the outer ends (i.e. cephalad end and caudal end). The body <NUM> of the implant <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> and <FIG>, the implant <NUM> may also contain a first channel or hole <NUM> and a second channel or screw hole <NUM>. The first hole <NUM> may receive, for example, fixation members, fasteners, screws, pegs, pins, springs and the like as known by one of ordinary skill in the art. The fixation members, fasteners, screws, pegs, and pins may be, for example smooth or threaded. The first hole <NUM> may be, for example, angled at a first trajectory as the hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The first hole <NUM> may be oriented, for example, on the caudal end for guiding a Jamshidi needle, k-wire, screw, or the like into the trajectory for placement in the pedicle. The second hole <NUM> may receive, for example, fixation members, fasteners, screws, pegs, pins, springs and the like as known by one of ordinary skill in the art. The fixation members, fasteners, screws, pegs, and pins may be, for example smooth or threaded. The second hole <NUM> may be, for example, angled at a second trajectory as the hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The second hole <NUM> may be oriented, for example, on the cephalad end for guiding a Jamshidi needle, k-wire, screw, or the like into the desired facet/pedicle trajectory. In one embodiment, for example, the facet/pedicle trajectory enters in the cephalad channel <NUM> and moves in a caudal direction and the pedicle trajectory enters in the caudal channel <NUM> and moves in a cephalad direction. The implant <NUM> may also contain a center channel or locking opening <NUM> positioned, for example, between the first screw hole <NUM> and the second screw hole <NUM>, as shown in <FIG> and <FIG>. The center channel <NUM> may be, for example, sized and shaped or configured to receive a fastener, for example, a set screw <NUM>, <NUM>, as shown in <FIG>. The fastener <NUM>, <NUM> may be used to place pressure on the screws (not shown) inserted through the holes <NUM>, <NUM> and into the facet/pedicle and/or pedicle, thereby securing or locking the bone fusion device. In addition, the implant <NUM> may include at least one lateral side indicator <NUM>, as shown in <FIG> and <FIG>. 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, machine marking or a like feature inset into the side of the body <NUM>, to indicate the lateral side of the implant <NUM>. Further, the at least one lateral side indicator <NUM> may further designate whether the implant <NUM> is a left or right implant.

Referring now to <FIG>, another implant or connector device <NUM> is shown. The implant <NUM> may be, for example, a uniaxial implant. The implant <NUM> may include a body <NUM> and a movable member, bushing, spherical bushing, rotating member or rotating fastener hole <NUM>, as shown in <FIG>. The body <NUM> and bushing <NUM> provide for angular fastener or screw adjustment along a single axis. The body <NUM> may include a top surface <NUM> opposite a bottom surface <NUM> and a first side <NUM> opposite a second side <NUM>, as shown in <FIG>. The body <NUM> may also include a housing or spherical portion <NUM> at a first end. The housing <NUM> may include a through hole <NUM> extending through the body <NUM> from a top surface <NUM> to a bottom surface <NUM>, as shown in <FIG>, <FIG> and <FIG>. The housing <NUM> may also include a spherical surface <NUM> inside the housing portion <NUM>, as shown in <FIG>, <FIG>, <FIG>. The interior spherical surface <NUM> may be, for example, shaped to correspond to an exterior surface of the bushing <NUM>. The spherical surface <NUM> of the housing <NUM> may include at least one slot <NUM> inset into the interior surface <NUM>, as shown in <FIG>, <FIG> and <FIG>. The at least one slot <NUM> may extend into the through hole <NUM> from a top surface <NUM> toward a bottom surface <NUM>. The bottom of the at least one slot <NUM> may include a locking portion or bottom portion <NUM>, as shown in <FIG> and <FIG>. The locking portion <NUM> may be, for example, sized and shaped or configured to secure the bushing <NUM> within the housing <NUM>. The housing <NUM> may be, for example, positioned on the caudal end or the cephalad end. As shown, the housing <NUM> may include, for example, two slots <NUM> each with a locking portion <NUM> at the bottom of the slots <NUM>. The diameter of the bottom portion <NUM> may be, for example, sized to receive a protrusion <NUM> on the bushing <NUM>. In addition, the slot <NUM> may extend from the bottom portion <NUM> at, for example, a <NUM> degree taper to the top of the slot <NUM>.

As shown in <FIG>, and <FIG>, the body <NUM> may also include, for example, a hole or opening <NUM> at a second end of the body <NUM>. The hole <NUM> may be, for example, a fixed hole receiving a fixation member, bone screw, fastener, peg, pin, and/or spring. The hole <NUM> may be, for example, angled at a first trajectory as the hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The hole <NUM> may be oriented, for example, for guiding a Jamshidi needle, k-wire, screw, or the like into the trajectory for placement in the pedicle or the facet/pedicle. The hole <NUM> may be, for example, positioned on the caudal end or the cephalad end. In one embodiment, for example, the facet/pedicle trajectory may enter the hole <NUM>, such as a cephalad channel, and move in a caudal direction and the pedicle trajectory may enter in the caudal opening <NUM> and move in a cephalad direction. Although not shown, it is also contemplated that the second end of the body <NUM> could include another housing <NUM> for receiving a second bushing <NUM> to allow for angular screw or fastener adjustment at both ends of the body <NUM>.

The body <NUM> may further include a locking opening or through hole <NUM>, as shown in <FIG>, and <FIG>. The locking opening <NUM> may be positioned, for example, between the through hole <NUM> and the hole <NUM>. The locking opening <NUM> may be sized and shaped or configured to allow an end of a handle member (not shown) to couple to the implant <NUM> for insertion into a patient. The locking opening <NUM> may also be, for example, sized and shaped or configured to receive a fastener, for example, a set screw <NUM>, <NUM>, as shown in <FIG>. The fasteners <NUM>, <NUM> may be used to place pressure on the fasteners or screws (not shown) inserted through the through hole <NUM> and the hole <NUM> and into the facet/pedicle, to secure or lock the bone fusion device. The implant <NUM> may further include at least one lateral side indicator <NUM>, as shown in <FIG>, <FIG>, <FIG>. 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, machine marking or a like feature inset into the side of the body <NUM>, to designate the lateral side of the implant <NUM>. In the depicted embodiment, the at least one lateral side indicator <NUM> is two alignment members <NUM>. Further, the at least one lateral side indicator <NUM> may further designate whether the implant <NUM> is a left or right implant.

As shown in <FIG>, the bushing <NUM> may include a body <NUM> with a through hole <NUM> extending through the bushing <NUM>. The bushing <NUM> may also include a slot <NUM> extending from an exterior surface into the through hole <NUM>, as shown in <FIG>. The bushing <NUM> may further include at least one ear, locking portion, slotted axel, or protrusion <NUM>, as shown in <FIG>. The at least one locking portion <NUM> may include tabs <NUM> with a slot <NUM> extending between the tabs <NUM>. In the depicted embodiment, the bushing <NUM> includes two protrusions. The spherical bushing <NUM> may provide, for example, infinite angles of delivery of the bone fastener (not shown). The bushing <NUM> may also include an upper rim <NUM> positioned on a top surface of the bushing <NUM>, as shown in <FIG>, and a lower rim <NUM> positioned on a bottom surface, as shown in <FIG>. The rims <NUM>, <NUM> may be tapered at each opening of the through hole <NUM>.

The implant <NUM> may be assembled by inserting the bushing <NUM> into the housing <NUM> of the body <NUM>. The bushing <NUM> may have, for example, a diameter that may correspond to the spherical interior surface or bore <NUM> in one end of the implant <NUM>. The bore <NUM> may have, for example, a spherical shape. The implant <NUM> may be, for example, factory assembled. During factory assembly, the bushing <NUM> may be compressed via the slot <NUM> in the bushing <NUM> and inserted into the bore <NUM> of the body <NUM>. The bushing <NUM> will then expand in the bore <NUM>, securely locking the bushing <NUM> within the body <NUM>. The bushing <NUM> may provide a <NUM> degree range of motion to address changes in patient anatomy. The tapers <NUM>, <NUM> on the opening <NUM> of the bushing <NUM> match the tapers of the fastener or bone screw (not shown). Once the fastener (not shown) is implanted in a bone and the taper under the head of the fastener makes contact with the taper <NUM>, <NUM> of the bushing, the taper of the fastener (not shown) will expand the bushing <NUM> and lock the entire construct. The fastener may be, for example, a fixation member, bone screw, peg, pin, and/or spring. The taper under the head of the screw will correspond to or match the taper of the bushing <NUM>.

The housing <NUM> of the implant <NUM> may allow for an angular adjustment of one of the screw fixation elements, bone screws, or fasteners (not shown). For example, a first fastener or screw (not shown) may be inserted through the hole <NUM> and into a patient's vertebrae. Then, a second fastener or screw (not shown) may be inserted through the through hole <NUM> and the direction of the fastener may be altered by the bushing <NUM> to accommodate the specific patient anatomy. In addition, the instrumentation, for example, the insertion guide <NUM> and locking block <NUM> may be configured or sized and shaped to allow for the angular adjustment positioning of the second fastener or fixation screw (not shown).

The implant <NUM> may be a part of a bone fusion device which may also include, for example, two cannulated fasteners, fixation screws or bone screws (not shown), and a central locking screw <NUM>, <NUM>, as shown in <FIG>. The two cannulated bone screws and central locking screw <NUM>, <NUM> are configured or sized and shaped to provide a non-co-planar screw trajectory while allow for or achieving fusion. The implant <NUM> may be sized and shaped or configured to assist with guiding the two fasteners or screws into a patient's vertebrae. For example, the implant <NUM> may be used to guide the fixation screws (not shown) into divergent aspects of the vertebrae and to lock the two divergent fasteners or screws into place. Specifically, the implant <NUM> may be used to guide a first fastener or screw into a patient's pedicle and a second fastener or screw into the patient's facet/pedicle of a vertebrae.

Referring now to <FIG>, another implant, connector device or polyaxial implant <NUM> is shown. The implant <NUM> may be, for example, a polyaxial implant. The implant <NUM> may include a body <NUM> and a bushing, spherical bushing, rotating member or rotating fastener hole <NUM>, as shown in <FIG>. The body <NUM> and bushing <NUM> provide for angular fastener or screw adjustment along multiple axes. The body <NUM> may include a top surface <NUM> opposite a bottom surface <NUM> and a first side <NUM> opposite a second side <NUM>, as shown in at least <FIG>. The body <NUM> may also include a housing or spherical portion <NUM> at a first end. The housing <NUM> may include a through hole <NUM> extending through the body <NUM> from the top surface <NUM> to the bottom surface <NUM>, as shown in <FIG>, <FIG>. The housing <NUM> may also include an interior surface or spherical surface <NUM> inside the housing portion <NUM>, as shown in <FIG>, <FIG> and <FIG>. The interior surface <NUM> may be, for example, shaped to correspond to an exterior surface of the bushing <NUM>. The interior surface <NUM> of the housing <NUM> may include a rim <NUM> surrounding the interior surface <NUM> near the top surface <NUM>. The housing <NUM> may also include a tapered portion from the rim <NUM> to the top surface <NUM>. The housing <NUM> may be, for example, positioned on the caudal end or the cephalad end.

As shown in <FIG>, <FIG>, the body <NUM> may also include, for example, a hole <NUM> at a second end of the body <NUM>. The hole <NUM> may be, for example, a fixed hole for receiving a fixation member, bone screw, fastener, peg, pin, and/or spring. The hole <NUM> may be, for example, angled at a first trajectory as the hole <NUM> extends from the top surface <NUM> to a bottom surface <NUM>. The hole <NUM> may be oriented, for example, for guiding a Jamshidi needle, k-wire, screw, or the like into the trajectory for placement in the pedicle or the facet/pedicle. The hole <NUM> may be, for example, positioned on the caudal end or the cephalad end. In one embodiment, for example, the facet/pedicle trajectory may enter the hole <NUM>, such as a cephalad channel, and move in a caudal direction and the pedicle trajectory may enter in the caudal opening <NUM> and move in a cephalad direction. Although not shown, it is also contemplated that the second end of the body <NUM> could include another housing <NUM> for receiving a second bushing <NUM> to allow for angular screw or fastener adjustment at both ends of the body <NUM>.

The body <NUM> may further include a locking opening or through hole <NUM>, as shown in <FIG>, <FIG>. The locking opening <NUM> may be positioned, for example, between the through hole <NUM> and the hole <NUM>. The locking opening <NUM> may be sized and shaped or configured to allow an end of a handle member (not shown) to couple to the implant <NUM> for insertion into a patient. The locking opening <NUM> may also be, for example, sized and shaped or configured to receive a fastener, for example, a set screw <NUM>, <NUM>, as shown in <FIG>. The fasteners <NUM>, <NUM> may be used to place pressure on the fasteners or screws (not shown) inserted through the through hole <NUM> and the hole <NUM> and into the facet/pedicle and pedicle, to secure or lock the bone fusion device. The implant <NUM> may further include at least one lateral side indicator <NUM>, as shown in <FIG> and <FIG>. 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, machine marking or a like feature inset into the side of the body <NUM>, to designate the lateral side of the implant <NUM>. In the depicted embodiment, the at least one lateral side indicator <NUM> is two alignment members <NUM>. Further, the at least one lateral side indicator <NUM> may further designate whether the implant <NUM> is a left or right implant.

As shown in <FIG>, the bushing <NUM> may include a body <NUM> with a through hole <NUM> extending through the bushing <NUM>. The bushing <NUM> may also include a slot <NUM> extending from an exterior surface into the through hole <NUM>, as shown in <FIG>. The bushing <NUM> may further include an upper rim <NUM>. The upper rim <NUM> may include, for example, a taper from the largest diameter of the exterior surface to a first end of the bushing <NUM>. The bushing <NUM> may also include a lower rim <NUM>. The lower rim <NUM> may include, for example, a taper from the largest diameter of the exterior surface to a second end of the bushing <NUM>. The spherical bushing <NUM> may provide, for example, infinite angles of delivery of the fastener or bone screw (not shown).

The implant <NUM> may be assembled by inserting the bushing <NUM> into the housing <NUM> of the body <NUM>. The body <NUM> may have, for example, a diameter that is smaller than the rim <NUM> for insertion of the movable member <NUM> within the body <NUM>. The implant <NUM> may be, for example, factory assembled. During factory assembly, the bushing <NUM> may be positioned to align the through hole <NUM> to be parallel with the top surface <NUM> of the implant <NUM> and the bushing <NUM> is then inserted into the bore <NUM> of the body <NUM>. The bushing <NUM> may then be rotated and the rim <NUM> of the body <NUM> will securely lock rims <NUM>, <NUM> of the bushing <NUM> within the body <NUM>. The bushing <NUM> may provide <NUM> degrees range of articulation to address changes in patient anatomy. Once the fastener or screw (not shown) is implanted in a bone and the fastener contacts the bushing <NUM> to lock the entire construct.

The housing <NUM> of the implant <NUM> may allow for an angular adjustment of one of the screw fixation elements, bone screws, or fasteners (not shown). For example, a first fastener or screw (not shown) may be inserted through the hole <NUM> and into a patient's vertebrae. Then, a second fastener or screw (not shown) may be inserted through the through hole <NUM> and the direction of the fastener or screw may be altered by the bushing <NUM> to accommodate the specific patient anatomy. In addition, the instrumentation, for example, the insertion guide <NUM> and locking block <NUM> may be configured or sized and shaped to allow for the angular adjustment positioning of the second fixation screw (not shown).

The implant <NUM> may be a piece of a bone fusion device which may also include, for example, two cannulated fasteners, fixation screws or bone screws (not shown), and a central locking screw <NUM>, <NUM>, as shown in <FIG>. The two cannulated bone screws and central locking screw <NUM>, <NUM> are configured or sized and shaped to provide a non-co-planar screw trajectory while allow for or achieving fusion. The implant <NUM> may be sized and shaped or configured to assist with guiding the two fasteners or screws into a patient's vertebrae. For example, the implant <NUM> may be used to guide the fixation screws (not shown) into divergent aspects of the vertebrae and to lock the two divergent fasteners or screws into place. Specifically, the implant <NUM> may be used to guide a first fastener or screw into a patient's pedicle and a second fastener or screw into the patient's facet/pedicle of a vertebrae.

Referring now to <FIG>, another insertion guide or cross bar guide tower <NUM> is shown. The insertion guide <NUM> may include a base member or top block <NUM> with a top surface <NUM> opposite a bottom surface <NUM>. The base member <NUM> may also include a first slot <NUM> forming an opening at a first end, a second slot <NUM> forming an opening at a second end, and a through hole <NUM> positioned between the first slot <NUM> and the second slot <NUM>. The first slot <NUM> may extend through the base member <NUM> from the top surface <NUM> to the bottom surface <NUM>. The first slot <NUM> may have, for example, a first trajectory which may be angled in a first direction. The first slot <NUM> may also extend, for example, parallel to the angled first end of the base member <NUM>. The second slot <NUM> may extend through the base member <NUM> from the top surface <NUM> to the bottom surface <NUM>. The second slot <NUM> may have, for example, a second trajectory which may be angled in a second direction. The second direction of the second slot <NUM> may be opposite the first direction of the first slot <NUM>. The first and second trajectories may be positioned to extend past each other to allow for insertion of fasteners or screws (not shown) in a crossed, X-shaped or V-shaped arrangement. The second slot <NUM> may also extend, for example, parallel to the angled second end of the base member <NUM>. The slots <NUM>, <NUM> may be, for example, angled approximately <NUM>-<NUM> degrees from a top surface <NUM> of the base member <NUM>, however, additional angles are also contemplated to correspond to variations in patient anatomy. The slots or guide wire through holes <NUM>, <NUM> may be used to aid in alignment of the insertion guide or construct <NUM>. The slots or slot features <NUM>, <NUM> allow for the insertion guide or tower <NUM> to be separated from the implant, for example, implant <NUM>, <NUM>, <NUM>, by releasing the guide wire (not shown). Although guide tower <NUM> is shown with a first and second slot <NUM>, <NUM>, it is also contemplated that the guide tower <NUM> may include either the first slot <NUM> or the second slot <NUM> and a through hole (not shown).

The through hole <NUM> may extend through the base member <NUM> from the top surface <NUM> to the bottom surface <NUM>. The through hole <NUM> may extend, for example, through the base member <NUM> perpendicular to the top and bottom surfaces <NUM>, <NUM>. As shown in <FIG> and <FIG>, the base member <NUM> may also include at least one hole <NUM>. The at least one hole <NUM> may extend between the sides of the base member <NUM>, for example, relatively perpendicular to the through hole <NUM> and relatively parallel to the top and bottom surfaces <NUM>, <NUM>. The at least one hole <NUM> may provide, for example, a point of reference for the surgeon for the position or location of the slots <NUM>, <NUM>. For example, the lateral holes <NUM> may align with the top surface or entrance to the slots <NUM>, 330and the medial holes <NUM> may align with the bottom surface or exit of the slots <NUM>, <NUM>. Although the at least one hole <NUM> is shown as through holes, it is also contemplated that the holes <NUM> may be recesses, grooves, machine markings, and the like to provide a point of reference for the surgeon. Further, the openings <NUM> may receive a pin to provide additional visual reference point for determining the position of the locking block <NUM> and a coupled implant during insertion into a patient. The top surface <NUM> may be, for example, longer than the bottom surface <NUM>. The base member <NUM> may have, for example, a generally trapezoidal cross-sectional shape forming, for example, a trapezoidal prism. Alternative polygonal shapes are also contemplated including, for example, at least, rectangles, parallelograms, and the like.

As shown in <FIG>, the connecting member <NUM> may have a first end and a second end. The first end of the connecting member <NUM> may be coupled to the base member <NUM> and aligned with the through hole <NUM>. The second end of the connecting member <NUM> may be coupled to the implant coupling portion or locking block <NUM>. The through hole <NUM> continues through the locking block <NUM> and is configured to receive a handle member (not shown). The handle member (not shown) may be similar to the handle member <NUM>, as described in greater detail below with reference to <FIG>, including a gripping portion and an at least partially threaded rod for engaging an implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> for insertion into a patient.

As shown in <FIG>, the locking block <NUM> includes a top surface <NUM> opposite a bottom surface <NUM> and a first side <NUM> opposite a second side <NUM>. The locking block <NUM> may also include a first slot <NUM> at a first end and a second slot <NUM> at a second end. The first and second slots <NUM>, <NUM> may extend from the top surface <NUM> to the bottom surface <NUM>. The first slot <NUM> may also extend from the exterior surface at the first end into the base member <NUM> to form a first opening and from the top surface <NUM> to the bottom surface <NUM>, as shown in <FIG> and <FIG>. The second slot <NUM> may also extend from the exterior surface at the second end into the base member <NUM> to form a second opening and from the top surface <NUM> to the bottom surface <NUM>, as shown in <FIG> and <FIG>. The first opening formed by the first slot <NUM> may also extend, for example, parallel to the angled first end of the locking block <NUM>. The first slot <NUM> may have, for example, a first trajectory which may be angled in a first direction. The first trajectory of the locking block <NUM> may, for example, correspond to the first trajectory of the base member <NUM> to allow for a Jamshidi needle, k-wire, screw, or the like to be inserted and removed through the first <NUM> of the base member <NUM> and the first slot <NUM> of the locking block <NUM>. The second slot <NUM> may also extend, for example, parallel to the angled second end of the locking block <NUM>. The second slot <NUM> may have, for example, a second trajectory which may be angled in a second direction. The second trajectory of the locking block <NUM> may, for example, correspond to the second trajectory of the base member <NUM> to allow for a Jamshidi needle, k-wire, screw, or the like to be inserted and removed through the second slot <NUM> of the base member <NUM> and the second slot <NUM> of the locking block <NUM>. The first and second trajectories may be selected, for example, to correspond to the desired placement in a patient's facet/pedicle and pedicle. The first and second slots <NUM>, <NUM> may be, for example, angled approximately <NUM>-<NUM> degrees from a top surface <NUM> of the locking block <NUM>, however, additional angles are also contemplated to correspond to variations in patient anatomy.

With continued reference to <FIG> and <FIG>, the locking block <NUM> may also include a center opening or through hole <NUM>. The through hole <NUM> is configured to allow a handle member (not shown) to pass through the locking block <NUM> and engage an implant, for example, the implant <NUM>, <NUM>, <NUM>. The through hole <NUM> may extend, for example, through the locking block <NUM> generally perpendicular to at least the bottom surface <NUM> of the locking block <NUM>. The locking block <NUM> may further include an alignment member <NUM> positioned on a side of the locking block <NUM>, as shown in <FIG> and <FIG>. The alignment member <NUM> may include at least one extension member <NUM> extending past the bottom surface <NUM> of the locking block <NUM>. The at least one extension member may be, for example, multiple fork extensions <NUM>. The at least one extension member of the alignment member <NUM> may be used to accurately locate the lateral aspect of an implant <NUM>, <NUM>, <NUM>.

The cross bar guide tower or insertion guide <NUM> may couple to the connector device or implant <NUM>, <NUM>, <NUM> while placing the trajectory devices (not shown) or fixation device insertion instruments (not shown), for example, a Jamshidi needle or k-wires. The top block or base member <NUM> of the instrument <NUM> incorporates guide holes or slots <NUM>, <NUM> to facilitate the insertion of a guide device (not shown) which may be, for example, a Jamshidi needle or similar device to aid in the delivery of a guide wire for subsequent surgical activities including passing the fixation screws through the locking block <NUM> to their final position.

Referring now to <FIG>, another implant or connector device <NUM> is shown. The implant or connector device <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 implant <NUM> may be, for example, a three-dimensional misshapen parallelogram which may be angled on the ends, bottom surface and at least one side. The length of the top surface <NUM> is longer than the length of the bottom surface <NUM> forming tapered ends, as shown in <FIG>. The implant <NUM> may also be, for example, shaped to have a low profile to avoid bone and tissue impingement. In addition, the body <NUM> of the implant <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>, the implant <NUM> may also contain a first channel or screw hole <NUM> and a second channel or screw hole <NUM>. The first hole <NUM> may be, for example, angled at a first trajectory as the hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The first hole <NUM> may be oriented, for example, on the caudal end for guiding a Jamshidi needle, k-wire, screw, or the like into the trajectory for placement in the pedicle. The second hole <NUM> may be, for example, angled at a second trajectory as the hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The second hole <NUM> may be oriented, for example, on the cephalad end for guiding a Jamshidi needle, k-wire, screw, or the like into the desired facet/pedicle trajectory. In one embodiment, for example, the facet/pedicle trajectory enters in the cephalad channel <NUM> and moves in a caudal direction and the pedicle trajectory enters in the caudal channel <NUM> and moves in a cephalad direction. The first and second trajectories may be positioned to extend past each other to allow for insertion of fasteners or screws (not shown) in a crossed, X-shaped or V-shaped arrangement. The first and second holes <NUM>, <NUM> may be, for example, angled approximately <NUM>-<NUM> degrees from a top surface <NUM> of the implant <NUM>, however, additional angles are also contemplated to correspond to variations in patient anatomy.

The implant <NUM> may also contain a center channel or locking opening <NUM> positioned, for example, between the first screw hole <NUM> and the second screw hole <NUM>, as shown in <FIG> and <FIG>. The center channel <NUM> may be, for example, sized and shaped or configured to receive a fastener, for example, a set screw <NUM>, <NUM>, as shown in <FIG>. The fastener <NUM>, <NUM> may be used to place pressure on the screws (not shown) inserted through the holes <NUM>, <NUM> and into the facet and/or pedicle, thereby securing or locking the bone fusion device. The center channel <NUM> may include, for example, threads <NUM>. In addition, the implant <NUM> may include at least one lateral side indicator <NUM>, as shown in <FIG>. 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, machine marking or a like feature inset into the side of the body <NUM>, to designate the lateral side of the implant <NUM>. Further, the at least one lateral side indicator <NUM> may further designate whether the implant <NUM> is a left or right implant.

Referring now to <FIG>, another implant or connector device <NUM> is shown. The implant or connector device <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 implant <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> is longer than the length of the bottom surface <NUM> forming tapered ends. The implant <NUM> may have a radius on the outer diameter of the first or medial side <NUM> to accommodate the spinous process. In one embodiment, for example, the first side <NUM> of the implant <NUM> may have approximately a <NUM> degree angle transitioning into a <NUM> radius, although other angles and radius sizes are contemplated. The implant <NUM> may also be, for example, shaped to have a low profile to avoid bone and tissue impingement. In addition, the body <NUM> of the implant <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>, the implant <NUM> may also contain a first channel or hole <NUM> and a second channel or hole <NUM>. The first hole <NUM> may be, for example, angled at a first trajectory as the hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The first hole <NUM> may be oriented, for example, on the caudal end for guiding a Jamshidi needle, k-wire, screw, or the like into the trajectory for placement in the pedicle. The second hole <NUM> may be, for example, angled at a second trajectory as the second hole <NUM> extends from a top surface <NUM> to a bottom surface <NUM>. The second hole <NUM> may be oriented, for example, on the cephalad end for guiding a Jamshidi needle, k-wire, screw, or the like into the desired facet/pedicle trajectory. In one embodiment, for example, the facet/pedicle trajectory enters in the cephalad channel <NUM> and moves in a caudal direction and the pedicle trajectory enters in the caudal channel <NUM> and moves in a cephalad direction. The first and second trajectories may be positioned to extend past each other (non-intersecting) to allow for insertion of fasteners or screws (not shown) in a crossed, X-shaped or V-shaped arrangement.

The implant <NUM> may also contain a center channel or locking opening <NUM> positioned, for example, between the first hole <NUM> and the second hole <NUM>, as shown in <FIG> and <FIG>. The center channel <NUM> may be, for example, sized and shaped or configured to receive a fastener, for example, a set screw <NUM>, <NUM>, as shown in <FIG>. The fastener <NUM>, <NUM> may be used to place pressure on the screws (not shown) inserted through the holes <NUM>, <NUM> and into the facet/pedicle and pedicle, thereby securing or locking the bone fusion device. The center channel <NUM> may include, for example, threads <NUM>. In addition, the implant <NUM> may include at least one lateral side indicator <NUM>, as shown in <FIG> and <FIG>. 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, machine marking or a like feature inset into the side of the body <NUM>, to designate the lateral side of the implant <NUM>. Further, the at least one lateral side indicator <NUM> may further designate whether the implant <NUM> is a left or right implant.

The implant <NUM>, <NUM> may be a piece or part of a bone fusion device which may also include, for example, two cannulated fasteners, fixation screws or bone screws (not shown), and a central locking screw <NUM>, <NUM>, as shown in <FIG>. The two cannulated bone screws and central locking screw <NUM>, <NUM> are configured or sized and shaped to provide a non-co-planar screw trajectory while allow for or achieving fusion. The implant <NUM>, <NUM> may be sized and shaped or configured to assist with guiding the two fasteners or screws into a patient's vertebrae. For example, the implant <NUM>, <NUM> may be used to guide the fixation screws (not shown) into divergent aspects of the vertebrae and to lock the two divergent fasteners or screws into place. Specifically, the implant <NUM>, <NUM> may be used to guide a first fastener or screw into a patient's pedicle and a second fastener or screw into the patient's facet/pedicle of a vertebrae.

Referring now to <FIG>, the first locking screw <NUM> is shown. The first locking screw <NUM> may include a threaded body <NUM>. The first locking screw <NUM> may also include a drive opening <NUM> at a first end and an engagement protrusion <NUM> at a second end. The drive opening <NUM> may be, for example, hexagonal, square, Phillips or another multi-lobed configuration for coupling with an insertion instrument. The engagement protrusion <NUM> may have a pointed end <NUM> and a triangular cross section. The base of the protrusion <NUM> may have a larger diameter than the connector portion.

A second locking screw <NUM> is shown in <FIG>. The second locking screw <NUM> may include a threaded body <NUM>. The second locking screw <NUM> may also include a drive opening <NUM> at a first end and an engagement protrusion <NUM> at a second end. The drive opening <NUM> may be, for example, hexagonal, square, Phillips or another multi-lobed configuration for coupling with an insertion instrument. The engagement protrusion <NUM> may be tapered as the engagement protrusion <NUM> extends away from the threaded portion of the threaded body <NUM>.

Referring now to <FIG> and <FIG>, a reduction tool <NUM> is shown. The reduction tool <NUM> may be used, for example, when a patient presents with spondylolisthesis or a displacement of a spinal vertebra in relation to an adjacent vertebra, to fix the spondylolisthesis prior to inserting stabilization devices, such as, fasteners, screws, connecting devices and the like. The reduction tool <NUM> may include a tower bolt or handle member <NUM>, a base member or holder <NUM>, coupling member <NUM>, bone contacting member <NUM>, and a ball lock, wing nut, or securement member <NUM>. The base member <NUM> may be coupled to the tower bolt <NUM> by the securement member <NUM>. In addition, the coupling member <NUM> may engage the base member <NUM> and may receive the bone contacting member <NUM>. The bone contacting member <NUM> may engage a patient's bone during insertion of a connector device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. Further, an end of the tower bolt <NUM> may be sized and shaped or configured to engage an implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. The handle member <NUM> may be used for directing the reduction tool <NUM> into the wound site. While the bone contacting member <NUM> may be used to apply pressure on the lamina once attached to the handle member <NUM> and inserted into the patient.

As shown in <FIG> and <FIG>, the handle member <NUM> may include a rod or shaft <NUM> with a first end <NUM> and a second end <NUM>. The first end <NUM> may be configured or sized and shaped to engage an implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. The second end <NUM> may be configured or sized and shaped to couple to a handle <NUM>. The base member <NUM> may include a body <NUM> with a slot or opening <NUM> positioned near a middle of the base member <NUM>. The opening <NUM> may also include a channel or cavity <NUM> extending from the opening <NUM> into the body <NUM>, as shown in <FIG>. The cavity <NUM> may be configured to receive a spring loaded mechanism or spring loaded ball <NUM>, as shown in <FIG>. The base member <NUM> may also include an arm <NUM> at a first end. The arm <NUM> may include a through hole <NUM> for receiving the bone contacting member <NUM>. The through hole <NUM> may be, for example, threaded. The base member <NUM> may further include a first leg or first fork portion <NUM>, a second leg or second fork portion <NUM> with a channel, recess or groove <NUM> extending between the first and second legs <NUM>, <NUM>. The channel <NUM> may be sized and shaped or configured to receive the shaft <NUM> of the handle member <NUM>. As shown in <FIG> and <FIG>, the base member <NUM> may also include a recess <NUM> in a portion of the legs <NUM>, <NUM> and a portion of the body <NUM> where the legs <NUM>, <NUM> engage the body <NUM>. The recess <NUM> is sized and shaped or configured to receive the body <NUM> of the securement member <NUM>.

The coupling member <NUM> may include a body <NUM> and an engagement member <NUM> extending away from one side of the body <NUM>. The body <NUM> may include a through hole <NUM>, which may be, for example, threaded. The engagement member <NUM> may be inserted into the opening <NUM> to couple the coupling member <NUM> to the base member <NUM>, as shown in <FIG>. The engagement member <NUM> may include a plurality of detents or grooves <NUM> positioned along the top surface of the engagement member <NUM>, as shown in <FIG>. The spring loaded ball <NUM> of the base member <NUM> may engage the detents <NUM> when the engagement member <NUM> is inserted into the slot <NUM>, as shown in <FIG>. As force is applied to the coupling member <NUM> to move the engagement member <NUM> within the slot <NUM> the spring loaded ball <NUM> may engage the detents <NUM> until a desired distance between the handle member <NUM> and the bone contact member <NUM> is achieved. Once the desired distance is selected, the spring loaded ball <NUM> will remain in the corresponding detent <NUM> at that distance to secure the bone contacting member <NUM> in the desired location for reducing the patient's vertebrae. The bone contacting member <NUM> may include a shaft <NUM> with a threaded end <NUM> at a first end and a foot <NUM> at a second end. The threaded end <NUM> is sized and shaped or configured to engage the through hole <NUM> of the coupling member <NUM>. The foot <NUM> may include at least one spike, tooth, concavity, curvature or other surface texture <NUM>.

The securement member <NUM> may have a body or coupling member <NUM> with a through hole <NUM> extending through the coupling member <NUM>, as shown in <FIG> and <FIG>. The securement member <NUM> may also include at least one wing, arm, or member <NUM> extending away from the body <NUM> for rotating the securement member <NUM>. The through hole <NUM> may be threaded onto the shaft <NUM> of the handle member <NUM>, as shown in <FIG>. In addition, after the base member <NUM> is aligned in the desired position on the shaft <NUM>, the securement member <NUM> may be rotated to engage the body <NUM> with the recess <NUM> of the base member <NUM> to secure the securement member <NUM> to the shaft <NUM>.

Referring now to <FIG>, a holder <NUM> is shown. The holder <NUM> may be, for example, a monolithic base member <NUM>, a coupling member <NUM> and a bone contacting member <NUM>. The holder <NUM> may include a base portion <NUM> with an arm <NUM> extending away from the base portion <NUM>. As shown in <FIG>, the arm <NUM> may include an opening or through hole <NUM>. The base portion <NUM> may also include a first leg or fork portion <NUM> and a second leg or fork portion <NUM> with a channel, recess, or groove <NUM> extending between the legs <NUM>, <NUM>. The base portion <NUM> may also include a recess <NUM> inset into a portion of the base portion <NUM> and a portion of each of the legs <NUM>, <NUM>, as shown in <FIG>. The holder <NUM> may also include a projection <NUM> with a first end of the projection <NUM> extending out from a middle portion of the holder <NUM>. The holder <NUM> may further include a bone contacting portion <NUM> coupled to a second end of the projection <NUM>. The bone contacting portion <NUM> may also include a shaft <NUM> with a distal end or foot <NUM> and a proximal end <NUM>. The proximal end <NUM> may be coupled to the projection <NUM>. The distal end or foot <NUM> may include at least one spike, tooth, concavity, curvature or other surface texture <NUM>.

One method not part of the claimed invention, of using a bone fusion system includes, for example, making a mid-line incision large enough for a tower instrument <NUM>, <NUM> and pre-assembled connector implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to fit as it is placed along the spinous process. Next, the method may include placing the coupled tower instrument <NUM>, <NUM> and connector implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> through the incision and positioning the connector implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> on the appropriate side of the spinous process <NUM>, as shown in <FIG>. The method may also include inserting a first Jamshidi needle through a first slot or facet slot on the tower instrument <NUM>, <NUM> and confirming the Jamshidi needle placement using fluoroscopy. The method may further include inserting a second Jamshidi needle through a second slot or pedicle slot on the tower instrument <NUM>, <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 Jamshidi tubes and confirming the desired k-wire <NUM> placement with fluoroscopy. Next, the method may include removing the Jamshidi tubes and disengaging the tower instrument <NUM>, <NUM> from the k-wires <NUM> and the connector implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. The method may further include removing the tower instrument <NUM>, <NUM> leaving the connector implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and k-wires <NUM> in place within the patient. Then, the method may include sliding a cannulated facet/pedicle screw over the facet/pedicle k-wire, driving the facet/pedicle screw into the bone, for example, the facet and pedicle, and confirming the placement with fluoroscopy. The method may also include sliding a cannulated screw over the k-wire, driving the pedicle screw into the pedicle, and confirming the placement with fluoroscopy. Next, the method may include removing the k-wires and inserting the center locking screw <NUM>, <NUM> until the locking screw pushes the facet/pedicle and pedicle screws slightly. Finally, the method may include confirming the correct placement of the bone fusion device with fluoroscopy.

In an example where the patient presents with a spondylolisthesis, after placing the two k-wires into the pedicle and the facet/pedicle, the guide tower <NUM>, <NUM> may be removed. Next, a cannulated screw may be placed over the k-wire and secured in place. The reduction tool <NUM> may then be coupled to the implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> through the incision before the second screw is placed, for example, before a screw is placed in the facet/pedicle. The foot <NUM>, <NUM> of the reduction tool <NUM> may be placed onto the inferior lamina and placement may be verified by fluoroscopy. The base member <NUM>, coupling member <NUM> and bone contacting member <NUM> may be attached to the superior aspect of the handle member <NUM>, then the securement member <NUM> may secure the base member <NUM> to the handle member <NUM>. When the securement member <NUM> is attached to the handle member <NUM> and engages the base member <NUM>, the securement member <NUM> pushes down on the bone contacting member <NUM>, which places a force on the lamina and may bend the shaft <NUM>. As the securement member <NUM> is rotated, the foot <NUM> contacts the lamina and the vertebrae is loaded to assist with realignment. Once the reduction tool <NUM> is assembled and bone contacting member <NUM> is firmly placed on the lamina, the coupled reduction tool <NUM> and implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be tilted caudally to use the reduction tool <NUM> as a lever to tilt the superior vertebra with the inserted screw into the pedicle. The length of the rod <NUM> may be selected to assist with the leverability during reduction. The reduction tool <NUM> is then used to change the relative position of the vertebrae and ultimately reducing the lysthesis. After reduction, the second screw, for example, the screw into the facet/pedicle can be placed over the second k-wire and fixed through the facet to complete the stabilization.

The anatomic fastener or screw insertion angle may be, for example, predetermined by the implant <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and targets the fastener trajectory via fastener holes in the device. The fasteners are implanted in such a fashion as to accomplish a non co-planer, axial divergent fastener trajectory.

In an example the first screw will be guided by the device <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and secured into bone through one of the through hole features or guide holes. The second screw is implanted at the opposite angle through one of the guide holes in the device <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and may be offset by a distance such as to allow the screws to pass to their desired final position. The compound angle of the screw generally forms a "V" shape, where the screws are at opposing angles and where one screw may be medial or lateral to the opposite screw by a distance of the diameter of the screw. The compound angle may be, for example, approximately <NUM>-<NUM> degrees. The two screws that form the "V" shape are then securely locked into place by a locking screw that is driven down an axis approximately at the center of the "V" shape until contact is made with each screw, loading both screws in a manner that forces the screws apart by, for example, slightly deforming or displacing the screw axis, into the locking block thus locking the screws to prevent rotation and axial displacement to secure the entire rigid construct.

The device <NUM>, <NUM>, <NUM>, <NUM>, <NUM> is not fixed to bone, the device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, two screws and locking screw will securely lock the bone screws to form a construct.

The device guide holes for fastener delivery are positioned at an optimum insertion based on anatomical and surgical data. The guide hole tolerances will provide several degrees of additional translation or angulation to address the variation in patient anatomy.

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

While the implants or devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are described above for fixation using one facet and one pedicle location, this is an example. The implants or devices <NUM>, <NUM>, <NUM>, <NUM>, <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, or a combination of the elements described above, as would be known by one of ordinary skill in the art.

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 invention. In addition, the devices and systems may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features of <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> may all be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. In addition, the components and features of, for example, <FIG> and <FIG> and <FIG> may all be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Accordingly, this detailed description of the currently-preferred embodiments is to be taken as illustrative, as opposed to limiting the invention.

Claim 1:
A bone fusion implant system (<NUM>), comprising:
a bone fusion insertion guide (<NUM>, <NUM>) comprising:
a base member (<NUM>, <NUM>) having a first opening (<NUM>, <NUM>) with a first trajectory and a second opening (<NUM>, <NUM>) with a second trajectory;
a connecting member (<NUM>, <NUM>) having a first end and a second end, wherein the first end is coupled to the base member (<NUM>, <NUM>); and
a locking block (<NUM>, <NUM>) coupled to the second end of the connecting member (<NUM>, <NUM>), wherein the locking block (<NUM>, <NUM>) has a first guide hole (<NUM>, <NUM>) and a second guide hole (<NUM>, <NUM>);
wherein the first trajectory of the first opening (<NUM>, <NUM>) corresponds to a first trajectory of the first guide hole (<NUM>, <NUM>) and the second trajectory of the second opening (<NUM>, <NUM>) corresponds to a second trajectory of the second guide hole (<NUM>, <NUM>); and
an implant (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) with a body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>), the body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprising:
a first hole (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) at a first end of the body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
a second hole (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) at a second end of the body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>); and
a locking opening (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) positioned between the first hole (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and the second hole (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
a top surface (<NUM>);
a bottom surface (<NUM>) opposite the top surface (<NUM>);
a first side (<NUM>); and
a second side (<NUM>) opposite the first side (<NUM>);
wherein the first side (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and the second side (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) extend from the top surface (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to the bottom surface (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>), and wherein the top surface (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) has a length, the bottom surface (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) has a length, and the length of the top surface (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is longer than the length of the bottom surface (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>).