Patent Description:
Transforaminal lumbar interbody fusion (TLIF) procedures are a standard surgery technique to provide support and stabilize the spinal vertebra and the disc space when treating a variety of spinal conditions, such as degenerative disc disease and spinal stenosis with spondylolisthesis. Clinical treatment of spinal pathologies may include precise placement of an interbody to restore anterior column alignment with bilateral pedicle screw (BPS) fixation to stabilize two or more adjacent vertebral bodies adjacent to spinal fusion levels.

Various iatrogenic pathologies may occur in association with interbody and bilateral pedicle screw placement. These pathologies may result from the surgical access window to the disc space, failure to precisely place the interbody along the apophyseal ring for quality cortical bone support, and/or failure to restore normal anatomical spinal alignment. latrogenic pathologies associated with pedicle screw fixation, may include, but are not limited to, misplacement of screws, muscle/ligament disruption during insertion, adjacent segment disease due to superior adjacent facet violation by the pedicle screw, and rod construct, procedural efficiency, and instrumentation failure.

The instrumentation needed to provide access into the disc through a tubular approach, provide a valued decompression, complete a quality discectomy efficiently, insert and deploy an interbody, and insert the pedicle screw and rod construct also require a multitude of radiographic imaging throughout the procedure. This all increases surgical operating time, radiation exposure, and can result in the misplacement of implants and screws.

<CIT>, <CIT>, <CIT>, <CIT>, <CIT> all disclose systems known in the art.

There exists a clinical need for a robotically enabled procedure that provides pre-operative planning that is compatible with navigated, intelligent instrumentation that (<NUM>) establishes safe and repeatable direct decompression while gaining access to the disc space; (<NUM>) provides enhanced navigated, powered discectomy technique; (<NUM>) allows for precision placement of an expandable interbody that increases surface area contact along the apophyseal ring through the posterior approach; and/or (<NUM>) utilizes a minimally invasive fixation method that stabilizes the adjacent vertebral bodies without violating the superior facet.

According to the invention it is provided a bi-portal robotically-enabled system having the features of claim <NUM>. Further advantageous aspects of the invention are set forth in the dependent claims.

To meet this and other needs, orthopedic implants, systems, instruments, and methods are provided. The implant system may include a three-legged expandable interbody used alone or in combination with one or more pedicle-based intradiscal fixation implants. The implants may be installed using a robotically-enabled bi-portal lumbar interbody fusion procedure with intelligent instrumentation capable of repeatably providing clinically superior segmental correction through stabilization and fixation methods that avoid violation of the superior adjacent facet joint for patients with one- or two-level degenerative conditions. The procedure may include one or more aspects of the following workflow which may be assisted and enhanced using imaging, navigation and/or robotics: (<NUM>) pre-operative planning; (<NUM>) end-effector set-up; (<NUM>) tubular access and decompression or alternative visualization port workflows; (<NUM>) bi-portal implant cannula insertion; (<NUM>) bi-portal discectomy; (<NUM>) interbody deployment, positioning, and expansion; (<NUM>) nitinol fixation construction; and (<NUM>) final verification.

According to one embodiment, an orthopedic system for stabilizing the spine includes an expandable interbody implant and first and second pedicle-based intradiscal implants. The expandable interbody implant may include a first expandable lateral leg, a second expandable lateral leg, and a third central leg pivotably connected between the first and second lateral legs. The first and second lateral legs are independently expandable in height to provide lordotic and/or coronal adjustments. The first and second pedicle-based intradiscal implants may each include a nitinol rod and a pedicle screw securable to the nitinol rod.

The pedicle-based intradiscal implant may include one or more of the following features. The nitinol rod may extend from a proximal end configured to mate with the pedicle screw to a distal end configured to engage bone. The nitinol rod may have a naturally curved state and the nitinol rod may be straightened for deployment. The curved state of the nitinol rod may be an arc up to <NUM>°. The nitinol rod may have a polygonal cross-section with planar faces. The nitinol rod may be configured to be inserted through a pedicle of an inferior vertebra, through a vertebral body of the inferior vertebra, through a disc space, and into a vertebral body of a superior vertebra. The proximal end of the nitinol rod may include an externally threaded portion configured to mate with an internally threaded portion of the pedicle screw. The pedicle screw may include a screw head with a threaded or roughened texture configured to be engaged by a polyaxial tulip head.

The expandable interbody implant may include one or more of the following features. The first and second lateral legs of the expandable interbody implant may be configured to angulate at one or more pins to increase the overall footprint of the implant. The first and second lateral legs may each include an actuation assembly including a drive screw configured to expand the first and second lateral legs and the central leg of the expandable interbody implant.

According to one embodiment, a pedicle-based intradiscal implant includes a bendable rod and a pedicle screw. The bendable rod may be comprised of a shape-memory material, such as nitinol. The bendable rod may extend from a proximal end having an outer threaded portion to a distal end with a sharp tip configured to engage bone. The bendable rod may have a polygonal cross-section with planar faces. The pedicle screw may extend from a proximal end with a screw head to a distal end with a tip configured to engage the bendable rod. The pedicle screw may have a threaded shaft with a hollow body for receiving the proximal end of the bendable rod. The threaded shaft may define an internal threaded portion configured to mate with the outer threaded portion of the bendable rod.

According to another embodiment, a system for deploying the pedicle-based intradiscal implant includes a deployment instrument configured to load and deploy the bendable rod. The deployment instrument includes a body having a longitudinal axis with a straight deployment tube configured to draw in the curved rod, thereby straightening the rod when held within the deployment tube, and a shaft with an impaction cap. The deployment instrument may include a T-shaped handle with a socket configured to be received over the shaft with the impaction cap. When the handle is rotated about the longitudinal axis of the deployment instrument, the bendable rod is drawn into the deployment tube. When the shaft of the deployment instrument is translated distally along the longitudinal axis of the instrument by striking the impaction cap, the shaft forces the bendable rod to deploy out of the deployment tube.

It is further described even if does not form part of the scope of the invention, a method for stabilizing the spine includes (<NUM>) positioning an expandable interbody implant in a disc space between superior and inferior vertebrae, the expandable interbody implant having three articulating and expandable legs; (<NUM>) deploying a first bendable rod from an ipsilateral pedicle of the inferior vertebra, thru the disc space, and into a vertebral body of the superior vertebra; (<NUM>) inserting a first pedicle screw through the ipsilateral pedicle of the inferior vertebra and driving the first pedicle screw over the first bendable rod to anchor the first bendable rod; (<NUM>) deploying a second bendable rod from a contralateral pedicle of the inferior pedicle, thru the disc space, and into the vertebral body of the superior vertebra; and (<NUM>) inserting a second pedicle screw through the contralateral pedicle of the inferior pedicle and driving the second pedicle screw over the second bendable rod to anchor the second bendable rod.

The method may further include articulating the three legs of the expandable interbody implant relative to one another to increase the overall footprint of the implant. The expandable interbody implant may be placed along the apophyseal ring of the vertebrae for cortical bone support. The expandable interbody implant may be expanded to independently control sagittal and coronal correction. The expandable interbody implant may be positioned in the disc space by inserting a magnetic cable assembly attached to the expandable interbody implant through an ipsilateral cannula, inserting an articulating magnet retrieval tool through a contralateral cannula to magnetically attract and connect to the magnetic cable assembly, and retracting the articulating magnet retrieval tool back through the contralateral cannula, thereby pulling the cable assembly into the contralateral cannula and positioning the expandable interbody implant in the disc space. The first intradiscal implant may be deployed through an ipsilateral cannula and the second intradiscal implant may be deployed through a contralateral cannula. The first and second intradiscal implants may be positioned medially relative to the expandable interbody implant. The first and second bendable rods may each be deployed with a deployment instrument having a deployment tube and a shaft with an impaction cap. Each bendable rod may be deployed by striking the impaction cap, thereby forcing the rod to deploy out of the deployment tube.

It is further described even if does not form part of the scope of the invention, a method of installing an expandable interbody implant in a disc space between two adjacent vertebrae may include: (<NUM>) inserting a cable assembly through an ipsilateral cannula, the cable assembly including a cable with a magnetic tip at one end and attachable to an expandable interbody implant at the other end, the expandable interbody implant having a first expandable lateral leg, a second expandable lateral leg, and a third central leg pivotably connected between the first and second lateral legs; (<NUM>) inserting an articulating magnet retrieval tool through a contralateral cannula; (<NUM>) articulating and guiding the articulating magnet retrieval tool toward the ipsilateral cannula to magnetically attract and connect to the magnetic tip of the cable assembly; and (<NUM>) retracting the articulating magnet retrieval tool back through the contralateral cannula, thereby pulling the cable assembly into the contralateral cannula and positioning the expandable interbody implant in the disc space.

The method of installing the expandable interbody implant may further include threading the cable assembly on the first expandable lateral leg of the expandable interbody implant before inserting the cable assembly through the ipsilateral cannula. The method may include attaching a first inserter to the expandable interbody implant while placing the cable under tension. The method may include feeding the expandable interbody implant through the ipsilateral cannula with the first inserter while the cable assembly pulls the expandable interbody implant into an articulated U-shaped position. After removing the cable assembly from the expandable interbody implant, a second inserter may be attached to the expandable interbody implant such that the first and second inserters are rigidly connected to the first and second lateral legs, respectively, thereby providing for dual control of the expandable interbody implant. The method may also include inserting a driver through each of the first and second inserters to independently expand the first and second lateral legs to control sagittal and coronal correction.

It is further described even if does not form part of the scope of the invention, a method for installing a pedicle-based intradiscal implant may include (<NUM>) loading a deployment instrument including a body having a longitudinal axis with a straight deployment tube and a shaft with an impaction cap, by drawing a rod having a naturally curved shape into the straight deployment tube, thereby straightening the rod when held within the deployment tube; (<NUM>) positioning the deployment tube at a pedicle of an inferior vertebra; and (<NUM>) deploying the rod from the deployment instrument by striking the impaction cap to translate the shaft of the deployment instrument along the longitudinal axis, thereby forcing the rod to deploy out of the deployment tube, wherein once deployed, the rod extends from the pedicle, thru a disc space, and into a vertebral body of a superior vertebra. The method for installing the pedicle-based intradiscal implant may further include securing a pedicle screw through the pedicle of the inferior vertebra and driving the pedicle screw over one end of the rod to anchor the rod.

According to another embodiment, a bi-portal robotically-enabled system may include a robotic system and a bi-portal assembly. The robotic system may include a base, including a computer, a display electronically coupled to the computer, a robot arm electronically coupled to the computer and movable based on commands processed by the computer, an end-effector having a guide tube electronically coupled to the robot arm, the guide tube having a central longitudinal axis, and a camera configured to detect one or more tracking markers. The bi-portal assembly may include a guide bar assembly supporting first and second navigated cannula assemblies. The guide bar assembly may include a central guide bar configured to be inserted into the guide tube and first and second lateral wings positioned on opposite sides of the guide bar. The first and second navigated cannula assemblies may each include a hollow tubular cannula configured to guide an instrument placed through the respective cannula along a desired access trajectory to a surgical area.

The bi-portal robotically-enabled system may include one or more of the following features. The bi-portal assembly may be configured to pivot about the central longitudinal axis of the guide tube of the end-effector. The first and second navigated cannula assemblies may each be configured to independently angulate with respect to the central longitudinal axis of the guide tube, thereby providing the desired access trajectories to the surgical area. The width between the cannulas of the first and second navigated cannula assemblies may be adjustable. The bi-portal assembly may include a plurality of tracking markers configured to monitor the guide bar assembly and first and second navigated cannula assemblies, thereby providing navigated and/or robotic assistance. The first lateral wing may support the first navigated cannula via a first supporting arm and the second lateral wing may support the second navigated cannula via a second supporting arm. The first and second lateral wings may each include an elongate slot, and the navigated cannula assemblies may slide along the respective slots to adjust the width and/or angulation of the cannulas. The guide bar may be configured to slide into and lock axially to the guide tube of the end-effector with an axial locking cap. The axial locking cap may include a locking button configured to engage with a groove on the guide bar. Rotational movement of the guide bar assembly may be lockable with a central wheel handle lock.

According to another embodiment, a bi-portal assembly may include a guide bar assembly and first and second navigated cannula assemblies. The guide bar assembly may include a central guide bar configured to be inserted into a guide tube of a robot system and first and second lateral wings positioned on opposite sides of the guide bar. The first and second lateral wings may each including an elongate slot. The first navigated cannula assembly may include a first cannula coupled to the first lateral wing. The first cannula may be configured to guide an instrument placed through the first cannula along a first access trajectory. The second navigated cannula assembly may include a second cannula coupled to the second lateral wing. The second cannula may be configured to guide an instrument placed through the second cannula along a second access trajectory. The first and second navigated cannula assemblies may slide along the respective slots in the first and second lateral wings to adjust the width and/or angulation of the first and second cannulas.

The bi-portal assembly may include one or more of the following features. The first and second navigated cannula assemblies may move along one or more ratchets, thereby providing for incremental adjustment of the width and/or angle of the first and second cannulas. The ratchets may include curvilinear ratchets configured to mimic the shape of the first and second lateral wings. The ratchets may be positioned above and below each of the elongate slots. The first and second navigated cannula assemblies may each include a rotatable knob configured to independently lock a final position of the first and second cannulas. The bi-portal assembly may include a plurality of tracking markers on the guide bar, the first and second lateral wings, and the first and second cannulas.

According to yet another embodiment, a bi-portal robotically-enabled method may include: (<NUM>) performing pre-operative planning with a robotic system having an end-effector with a guide tube including taking pre-operative images and planning positioning of one or more implants; (<NUM>) introducing a guide bar of a bi-portal assembly into the guide tube of the end-effector, the bi-portal assembly comprising a guide bar assembly supporting first and second navigated cannula assemblies each configured to guide an instrument along a desired access trajectory; (<NUM>) accessing a surgical site through the first and second navigated cannula assemblies to perform a decompression; (<NUM>) positioning implant cannulas through the first and second navigated cannula assemblies; (<NUM>) performing a discectomy through the implant cannulas; (<NUM>) deploying an interbody implant through the implant cannulas; (<NUM>) installing intradiscal implants through the guide tube of the end-effector; and (<NUM>) verifying final positioning of the interbody and intradiscal implants. The first and second navigated cannula assemblies may each include an adjustable depth stop configured to set the access depth into the surgical site.

Also provided are kits including implants of varying types and sizes, rods, fasteners or anchors, various instruments and tools, k-wires, and other components for performing the procedures.

A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein:.

Embodiments of the disclosure are generally directed to orthopedic implants, systems, instruments. In particular, a bi-portal lumbar interbody fusion procedure may include an expandable interbody that increases surface area contact along the apophyseal ring through the posterior approach and minimally invasive pedicle-based intradiscal fixation implants that stabilize the adjacent vertebral bodies without violating the superior facet. The interbody and intradiscal implants may be installed with intelligent instrumentation capable of repeatably providing precision placement of the implants. The procedure may be performed with or without navigation and/or robotic assistance. The robotically-enabled procedure may utilize imaging, navigation, and robotics to enhance the quality and efficiency of the posterior procedure through planning and navigable instrumentation.

Additional aspects, advantages and/or other features of example embodiments of the invention will become apparent in view of the following detailed description. It should be apparent to those skilled in the art that the described embodiments provided herein are merely exemplary and illustrative and not limiting. Numerous embodiments and modifications thereof are contemplated as falling within the scope of this disclosure and equivalents thereto.

Referring now to <FIG>, an interlaminar lumbar interbody fusion system or orthopedic fixation system <NUM> is shown for fusing two adjacent vertebrae <NUM>. The fixation system <NUM> may include an expandable interbody implant <NUM> and one or more pedicle-based fixation implants <NUM>. The expandable interbody implant <NUM> is positioned in the disc space <NUM> between the superior and inferior vertebral bodies <NUM>. The interbody implant <NUM> may be placed along the apophyseal ring for cortical bone support. The expandable interbody implant <NUM> may include dual, independent expansion and angulation to adjust lordosis and/or coronal balance, thereby allowing for restoration of spinal anatomical alignment. The pedicle fixation implant <NUM> may include an intradiscal device configured to be deployed from the inferior pedicle <NUM>, thru inferior vertebral body <NUM>, thru the intradiscal space <NUM>, and into the superior vertebral body <NUM>. First and second pedicle fixation implants <NUM> may be positioned through the pedicles <NUM> of the inferior vertebra <NUM> and medially relative to the interbody implant <NUM>. The fixation system <NUM> may provide for superior segmental correction from stabilization device <NUM> with independently controlled sagittal and coronal correction and increased stability from increased endplate contact along the apophyseal ring as well as a fixation construct that avoids violation of the superior facet joint and the potential iatrogenic effects of a traditional bilateral pedicle construct.

Turning now to <FIG>, the expandable interbody implant <NUM> may include three sections or legs <NUM>, <NUM>, <NUM>, which are configured to articulate or pivot relative to one another at pins <NUM> to increase the overall width or footprint of the implant <NUM>. The implant <NUM> may include a first expandable lateral leg <NUM>, a second expandable lateral leg <NUM>, and a third anterior leg or central leg <NUM> with link plates <NUM>, which connect the first and second lateral legs <NUM>, <NUM>. Each of the lateral leg <NUM>, <NUM> may include an actuation assembly <NUM>, for example, including a drive screw or actuator configured to move a plurality of driving ramps, which expand the endplates of the lateral legs <NUM>, <NUM> in height. When the first and/or second lateral legs <NUM>, <NUM> are independently expanded in height, the attached link plates <NUM> are configured to passively increase in height, thereby providing lordotic and/or coronal adjustments.

Turning now to <FIG>, the pedicle-based fixation implant <NUM> may be made up of two biocompatible components: a rod <NUM> and a screw <NUM>. The rod <NUM> may be composed of nitinol or other shape-memory material, which allows the rod <NUM> to bend into a curved state upon deployment. The nitinol rod <NUM> may include a proximal end <NUM> configured to mate with the pedicle screw <NUM> and a distal end <NUM> configured to engage bone. The super elasticity of nitinol allows for the material to be drawn into a straight configuration from its naturally curved state. In its relaxed state, the nitinol rod <NUM> may have a curve or arc of <NUM>° or a curve or arc up to <NUM>°. The body of the nitinol rod <NUM> may have a polygonal cross-section with planar faces. For example, the body may have a quadrilateral cross-sectional shape, such as a square. The distal end <NUM> may include a pointed or sharp tip configured to pierce bone. The proximal end <NUM> may include a threaded portion <NUM> which mates with the screw <NUM>. The nitinol rod <NUM> may be deployed through the pedicle <NUM> of the inferior vertebra <NUM> and the distal end <NUM> may pass through the vertebral body <NUM> of the inferior vertebra <NUM>, through the disc space <NUM>, and into the vertebral body <NUM> of the superior vertebra <NUM>.

The screw <NUM> may include a pedicle screw that extends from a proximal end with a screw head <NUM> to a distal end with a tip <NUM> configured to engage the nitinol rod <NUM>. The screw <NUM> may be comprised of titanium or any suitable biocompatible material. The screw head <NUM> may define a drive recess that can be engaged by a screw-driving instrument or other device. The screw head <NUM> may have any general shape. In the embodiment shown, the screw head <NUM> has a curved or spherical surface that is threaded or roughened. The screw head <NUM> may interface with a polyaxial tulip head, which may retain a spinal rod. Examples of tulip heads and rod constructs are described in more detail, for example, in <CIT>. The screw <NUM> has a threaded shaft <NUM> configured to engage bone. It will be appreciated that the threaded shaft <NUM> may have a number of different features, such as lead(s), thread pitch, thread angle, shaft diameter to thread diameter, overall shaft shape, and the like. It is also contemplated that the threaded shaft <NUM> could be substituted with another suitable bone fastener, such as an anchor, clamp, or the like configured to engage bone.

The threaded shaft <NUM> of the pedicle screw <NUM> may define a hollow body for receiving the proximal end <NUM> of the nitinol rod <NUM>. The hollow body may extend along a portion or the entire length of the screw <NUM>. The hollow body defines an internal threaded portion configured to mate with the outer threaded portion <NUM> of the nitinol rod <NUM>. It will be appreciated that one or more additional features may be used to lock the screw <NUM> to the nitinol rod <NUM>, such as a snap ring within the pedicle screw <NUM> configured to snap into an external groove <NUM> of the nitinol rod <NUM>. The pedicle screw <NUM> may be deployed through the same pedicle <NUM> of the inferior vertebra <NUM> as the nitinol rod <NUM>. The pedicle screw <NUM> is inserted and driven over the proximal threads <NUM> of the nitinol rod <NUM> to purchase the existing cortical bone in the pedicle <NUM> and anchor the proximal end <NUM> of the nitinol rod <NUM> to the inferior pedicle <NUM>.

Turning now to <FIG>, the interlaminar lumbar interbody fusion procedure may have a structured workflow <NUM> for preparing and installing the expandable interbody implant <NUM> and pedicle-based fixation implants <NUM>. The workflow <NUM> may include one or more of the following steps. (<NUM>) Pre-operative imaging <NUM> may be performed of the patient anatomy, such as CT (computed tomography), MRI (magnetic resonance imaging), or other relevant imaging. (<NUM>) Pre-operative planning <NUM> may provide for planned placement of the expandable interbody <NUM>, planned access paths, planned placement of the nitinol rod fixation devices <NUM>, and a review of the plan strategy. (<NUM>) Access and decompression <NUM> of the disc space <NUM> may be set according to the plan. The disc space <NUM> may be accessed through a MIS (minimally invasive surgery) or open surgery. The access may utilize navigated instrumentation and/or robotic assistance. (<NUM>) A bi-portal discectomy <NUM> may be performed to increase the efficiency and overall quality of soft tissue removal. (<NUM>) Interbody deployment <NUM> may include deploying, positioning, articulating, and expanding the implant <NUM>. (<NUM>) Nitinol fixation deployment <NUM> may include deploying the pedicle-based intradiscal fixation implants <NUM> through the pedicles <NUM> of the inferior vertebra <NUM> and into the vertebral body <NUM> of the superior vertebra <NUM>. (<NUM>) Final verification <NUM> may include checking the location of the interbody and pedicle-based fixation implants <NUM>, <NUM> and ensuring the final construct is accomplishing the pre-operative plan and achieving the desired correction. The workflow <NUM> may be assisted and enhanced using imaging, navigation and/or robotics.

<FIG> illustrate an example of a surgical robotic and navigation system <NUM>. The surgical robot system <NUM> may include, for example, a surgical robot <NUM>, a base <NUM> including a computer, a display or monitor <NUM> (and optional wireless tablet) electronically coupled to the computer, one or more robot arms <NUM> controlled by the computer, and an end-effector <NUM> including a guide tube <NUM> electronically coupled to the robot arm <NUM>. The surgical robot system <NUM> may also utilize a camera <NUM>, for example, positioned on a separate camera stand <NUM>. The camera stand <NUM> can have any suitable configuration to move, orient, and support the camera <NUM> in a desired position. The camera <NUM> may include any suitable camera or cameras, such as one or more infrared cameras (e.g., bifocal or stereophotogrammetric cameras), able to identify, for example, active and/or passive tracking markers in a given measurement volume viewable from the perspective of the camera <NUM>. The camera <NUM> may scan the given measurement volume and detect the light that comes from the markers in order to identify and determine the position of the markers in three-dimensions. For example, active markers may include infrared-emitting markers that are activated by an electrical signal (e.g., infrared light emitting diodes (LEDs)), and passive markers may include retro-reflective markers that reflect infrared light (e.g., they reflect incoming IR radiation into the direction of the incoming light), for example, emitted by illuminators on the camera <NUM> or another suitable device.

The surgical robot <NUM> is able to control the translation and orientation of the end-effector <NUM>. The robot <NUM> may be able to move end-effector <NUM> along x-, y-, and z-axes, for example. The end-effector <NUM> can be configured for selective rotation about one or more of the x-, y-, and z-axis, and a Z Frame axis (such that one or more of the Euler Angles (e.g., roll, pitch, and/or yaw) associated with end-effector <NUM> can be selectively controlled). In some exemplary embodiments, selective control of the translation and orientation of end-effector <NUM> can permit performance of medical procedures with significantly improved accuracy.

The robotic positioning system <NUM> includes one or more computer controlled robotic arms <NUM> to assist the surgeon in planning the position of one or more navigated instruments relative to intraoperative patient images. The system <NUM> includes 2D & 3D imaging software that allows for preoperative planning, navigation, and guidance through a dynamic reference base, navigated instruments, and positioning camera <NUM> for the placement of spine, orthopedic, or other devices. Further examples of surgical robotic and/or navigation systems can be found, for example, in <CIT> and <CIT>.

Turning now to <FIG> and <FIG>, a bi-portal posterior access system and technique is shown, which may be robotically-enabled to assist a surgeon during surgery. A bi-portal assembly <NUM> may be configured to attach to the guide tube <NUM> of the end-effector <NUM> of the robot <NUM>. In this manner, the robot <NUM> is configured to control the location and orientation of the bi-portal assembly <NUM> relative to the surgical area. The bi-portal assembly <NUM> includes a guide bar assembly <NUM>, a first navigated cannula assembly <NUM>, and a second navigated cannula assembly <NUM>. The entire bi-portal assembly <NUM> is configured to pivot or rotate about the central longitudinal axis A of the guide tube <NUM> of the end-effector <NUM>. The first and second navigated cannula assemblies <NUM>, <NUM> are each configured to independently angulate with respect to the central longitudinal axis A, thereby providing the desired access trajectories to the surgical area. The bi-portal assembly <NUM> may include a plurality of tracking markers <NUM> configured to monitor the various features of the bi-portal assembly <NUM> and provide navigated and/or robotic assistance during the surgery.

As best seen in <FIG>, the guide bar assembly <NUM> includes a central guide bar <NUM> configured to be inserted into the bottom of the guide tube <NUM> of the end-effector <NUM>. The guide bar assembly <NUM> includes a central support arm <NUM> for holding first and second lateral wings <NUM>, <NUM>. The first and second lateral wings <NUM>, <NUM> are positioned on opposite sides of the guide bar <NUM> and extend outwardly in opposite directions from one another. The first lateral wing <NUM> supports a first navigated cannula <NUM> via a first supporting arm <NUM> and the second lateral wing <NUM> supports a second navigated cannula <NUM> via a second supporting arm <NUM>. The navigated cannulas <NUM>, <NUM> each include a long hollow tubular body defining a central longitudinal axis A1, A2, respectively. Each navigated cannula <NUM>, <NUM> is configured to guide an instrument placed through the respective cannula <NUM>, <NUM> along the desired trajectory to the surgical site.

With further emphasis on <FIG>, the guide bar <NUM> is configured to slide into and lock axially to the guide tube <NUM> of the end-effector <NUM>. For example, the guide bar <NUM> may snap into an axial locking cap <NUM>. The axial locking cap <NUM> may be snapped on an inside portion of the end-effector <NUM> to avoid blocking the infrared LEDs <NUM>, which act as tracking markers for the end-effector <NUM>. An upper portion of the locking cap <NUM> may rest on a top surface of the end-effector <NUM> above the guide tube <NUM>. The locking cap <NUM> may include a locking button <NUM> configured to engage with a groove <NUM> of the guide bar <NUM>. The groove <NUM> may be located between two annular rings at the proximal end of the guide bar <NUM>. The locking button <NUM> may be spring-loaded to automatically engage the groove <NUM> when the guide bar <NUM> is slid upwards through the inner diameter of the guide tube <NUM> of the end-effector <NUM>. When locked with the locking cap <NUM>, the guide bar assembly <NUM> is axially constrained to the guide tube <NUM>, but is still permitted to rotate about the longitudinal axis A of the guide tube <NUM>. Alternatively, the locking connection to the end-effector <NUM> of the robot <NUM> could be built into the guide bar <NUM> rather connecting through the end-effector <NUM>. It will be appreciated that other suitable locking mechanisms may also be utilized.

After the guide bar assembly <NUM> is axially locked to the end-effector <NUM>, the guide bar assembly <NUM> may be rotated to the desired location. As shown in <FIG>, the first and second lateral wings <NUM>, <NUM> may be rotated about the longitudinal axis A of the guide tube <NUM>. Once the desired rotational position is obtained, the rotational movement of the assembly <NUM> may be fixed with a central wheel handle lock <NUM>. The central wheel handle lock <NUM> may have a threaded stud <NUM> mounted into a threaded hole in the guide bar assembly <NUM>. Rotation of the central wheel handle lock <NUM> tightens, holds, and locks the final position of the guide bar assembly <NUM>. It will be appreciated that another suitable lock may also be utilized to secure the guide bar assembly <NUM>.

With emphasis on <FIG>, after the rotational position has been locked, the width and/or angulation of the first and second navigated cannulas <NUM>, <NUM> may be independent adjusted. The first and second lateral wings <NUM>, <NUM> may be curved or angled to allow for angular adjustments of the cannulas <NUM>, <NUM> as the cannulas <NUM>, <NUM> move along the lateral wings <NUM>, <NUM>. For example, the first and second lateral wings <NUM>, <NUM> may be curved or angled such that the terminal ends of the wings <NUM>, <NUM> point downwards, thereby providing for a greater degree of angulation as the cannulas <NUM>, <NUM> move further from the central guide bar <NUM>.

Each of the first and second lateral wings <NUM>, <NUM> may include an elongate slot <NUM> for securing the respective first and second navigated cannula assemblies <NUM>, <NUM>. The navigated cannula assemblies <NUM>, <NUM> may slide along the respective slots <NUM> to adjust the width and/or angulation of the cannulas <NUM>, <NUM>. As best seen in <FIG>, a top surface of the wings <NUM>, <NUM> may each include graduations, an indicator scale, or other markings <NUM> to provide visual feedback on the distance and/or angle of the cannulas <NUM>, <NUM>. For example, each graduated scale <NUM> may range from <NUM>-<NUM>° in increments of <NUM>° for each cannula <NUM>, <NUM>. An opening <NUM> in the top face of support arm <NUM>, <NUM> of the cannula assembly <NUM>, <NUM> may provide an exact reading of the graduated marking on the indicator scale <NUM>.

The cannula assemblies <NUM>, <NUM> may move along one or more ratchets <NUM>. The ratchets <NUM> may include linear or curvilinear ratchets <NUM> configured to mimic the shape of the lateral wings <NUM>, <NUM>. The ratchets <NUM> may be positioned above and below the elongate slots <NUM>. The ratchets <NUM> may include a rack and pinion system for independently moving the cannula assemblies <NUM>, <NUM> along the lateral wings <NUM>, <NUM>. The ratchets <NUM> may provide for incremental adjustment of the width and/or angle of the cannulas <NUM>, <NUM>. For example, the angle of the first cannula <NUM> may be aligned to match the desired location of the first lateral leg <NUM> of the implant <NUM> and the angle of the second cannula <NUM> may be aligned to match the desired location of the second lateral leg <NUM> of the implant <NUM>. In addition, the width between the first and second cannulas <NUM>, <NUM> may be matched to the desired width between the lateral legs <NUM>, <NUM> of the implant <NUM>. The width and/or angle of the cannulas <NUM>, <NUM> may each be independently locked with a rotatable knob <NUM>. Rotation of each of the knobs <NUM> tightens, holds, and locks the final position of each of the cannulas <NUM>, <NUM>. It will be appreciated that any suitable lock may be utilized to secure the cannulas <NUM>, <NUM>.

The bi-portal assembly <NUM> may include a plurality of tracking markers <NUM>, such as passive spherical markers, configured to monitor the position of the guide bar assembly <NUM> and first and second navigated cannula assemblies <NUM>, <NUM>, respectively. In the embodiment shown, nine markers <NUM> are used to track the locations and positions of the components, but it will be appreciated that any suitable number and configuration of markers may be selected. The distal end of the guide bar <NUM> may include a first tracking marker <NUM>. The terminal end of first lateral wing <NUM> may include a second tracking markers <NUM> and the terminal end of the second lateral wing <NUM> may include a third tracking marker <NUM>. The bottom of the first supporting arm <NUM> may include a fourth tracking marker <NUM> and the bottom of the second supporting arm <NUM> may include a fifth tracking marker <NUM>. The first navigated cannula <NUM> may include sixth and seventh tracking markers <NUM> aligned along the central longitudinal axis A1 of the cannula <NUM>. The second navigated cannula <NUM> may include eighth and ninth tracking markers <NUM> aligned along the central longitudinal axis A2 of the cannula <NUM>. In this manner, the tracking markers <NUM> are configured to provide information to the robot system <NUM> regarding the cannulas <NUM>, <NUM> and the bi-portal assembly <NUM>, such as the location, orientation, distance, angles, and other relevant information.

Turning now to <FIG>, <FIG>, each cannula assembly <NUM>, <NUM> may include an adjustable stop <NUM>, <NUM> configured to set the access depth into the surgical site. Depth control may be set independently for each of the trajectories for customized access, for example, for abnormal patient anatomy. Each stop <NUM>, <NUM> may include a sleeve or tubular body configured to slide over or along the respective cannula <NUM>, <NUM>. The stop <NUM>, <NUM> may slide along an elongate slit <NUM> extending along the central longitudinal axis A1, A2 of the cannula <NUM>, <NUM>. A pin or other engagement member from the stop <NUM>, <NUM> may be receivable in the slit <NUM> to guide the stop <NUM>, <NUM> to the desired depth. The depth may be locked with a lever latch <NUM>. The lever latch <NUM> may include a pair of pivotable thumb latches positioned on opposite sides of the cannula <NUM>, <NUM>. When depressed and squeezed together, the lever latch <NUM> allows the depth stop <NUM>, <NUM> to slide along the length of the cannula <NUM>, <NUM>. When released, the lever latch <NUM> locks the position of the depth stop <NUM>, <NUM>, thereby providing a maximum access depth for any instruments placed through the cannula <NUM>, <NUM>. For the embodiment shown in <FIG>, the right trajectory along axis A1 provides for deeper access to the disc space <NUM> than the left trajectory along axis A2. It will be appreciated that the stops <NUM>, <NUM> may be independently adjusted to provide the same or different access depths. Alternatively, instead of manual control, the robot <NUM> may control and auto-generate the width, angulation, and/or adjustable depth control settings for the cannulas <NUM>, <NUM>.

With emphasis on <FIG>, a navigated instrument <NUM> may be positioned through each cannula <NUM>, <NUM> to access the surgical site. The navigated instrument <NUM> may extend from a proximal end <NUM> with a handle configured to be gripped by a user to a distal end <NUM> with a tip configured to access the surgical site. The navigated instrument <NUM> may include an array <NUM> with a plurality of tracking markers <NUM>, such as spherical passive markers, configured to identify and monitor movement of the instrument <NUM> by the navigation and robotic system <NUM>. The navigated instrument <NUM> may be compatible with dilators, off-center sheaths, docking facet dilators, and other instrumentation. <FIG> show instruments <NUM> positioned through cannulas <NUM>, <NUM>, respectively. The stops <NUM>, <NUM> may be adjusted with the instrumentation <NUM> present. By removing the navigated array <NUM>, instruments <NUM> may provide improved visualization of the surgical site.

With emphasis on <FIG>, direct visualization port assemblies <NUM>, <NUM> are shown according to one embodiment. The direct visualization port assemblies <NUM>, <NUM> may replace the cannula assemblies <NUM>, <NUM> to increase visualization of the neural elements during decompression. The first lateral wing <NUM> of the guide bar assembly <NUM> supports the first port assembly <NUM> and the second lateral wing <NUM> of the guide bar assembly <NUM> supports the second port assembly <NUM>. Each of the port assemblies <NUM>, <NUM> may include an access port <NUM>, a moveable attachment assembly <NUM>, and an extension arm <NUM> connecting the access port <NUM> to the attachment assembly <NUM>. In the same manner as the cannula assemblies <NUM>, <NUM>, the attachment assemblies <NUM> may slide along the respective slots <NUM> through the first and second lateral wings <NUM>, <NUM> to adjust the width and/or angulation between the port assemblies <NUM>, <NUM>. As shown in <FIG>, each attachment assembly <NUM> and access port <NUM> may be aligned along a central longitudinal axis B1, B2.

The access port <NUM> may include a hollow tubular body for accessing the surgical site. The port <NUM> may be attached to the distal end of the extension arm <NUM> with a collar <NUM> that provides for a pivotable joint at the proximal end of the access port <NUM>. The collar <NUM> may have a conical, spherical, or other suitable interface with the port <NUM> to allow for independent angulation of the port <NUM>. As shown in <FIG>, the right port <NUM> is able to angulate laterally outward and off-axis of longitudinal axis B1. In <FIG>, the right port <NUM> is able to angulate inwardly toward mid-line but still off-axis of longitudinal axis B1. It will be appreciated that both the left and right ports <NUM> have independent angulation based on the desired access to the surgical site. The depth of the ports <NUM> may also be controlled via the extension arms <NUM>. The extension arm <NUM> may translate the port <NUM> toward or away from the surgical site, thereby providing for customized adjustability of each of the ports <NUM>. Accordingly, the width and angulation between the ports <NUM>, the conical angulation of the ports <NUM>, and the depth of the ports <NUM> may be adjusted to increase visualization and improve safety around the neural elements of the spine.

<FIG> depict a navigatable instrument assembly <NUM> according to one embodiment. The navigatable instrument assembly <NUM> may include an instrument <NUM> and adjustable stop <NUM>. Although stop <NUM> is described, it will be appreciated that stop <NUM> is the same or another suitable stop may be substituted. The instrument <NUM> may include a body that extends from a proximal end <NUM> configured to attach to a powered handle to a distal end <NUM> having the instrument tip. The instrument tip <NUM> may include burrs, drills, osteotomes, reamers, or other suitable instruments for cutting and/or removing bone. The instrument <NUM> may be powered to provide for high-speed, oscillating, or other suitable powered tips <NUM>. The shaft <NUM> of the instrument <NUM> may support an array <NUM> having a plurality of tracking markers <NUM>, such as spherical passive markers, configured to identify and monitor movement of the instrument <NUM> by the navigation and robotic system <NUM>. The shaft <NUM> of the instrument <NUM> is receivable through a securing sleeve <NUM> which attaches the adjustable stop <NUM> to the instrument <NUM>. The securing sleeve <NUM> is positioned through the tubular body of the adjustable stop <NUM>. The securing sleeve <NUM> includes an enlarged neck <NUM> at its proximal end configured to abut the proximal end of the stop <NUM> when received therethrough. The securing sleeve <NUM> includes one or more ribbed portions <NUM> configured to interface with the pivotable thumb latches of the lever latch <NUM>, thereby securing the position of the stop <NUM>. The instrument assembly <NUM> may be navigated alone or through a cannula, such as one of the navigated cannulas <NUM>, <NUM>, to perform the surgical procedure.

Turning now to <FIG> and <FIG>, an adjustable implant cannula <NUM> is shown according to one embodiment. The adjustable implant cannula <NUM> includes a hollow cannula body <NUM> and an adjustable threaded cap <NUM>. The cannula body <NUM> extends from a proximal end <NUM> to a distal end <NUM>. The proximal portion <NUM> may be externally threaded to engage with the internally threaded cap <NUM>. As the cap <NUM> is rotated the overall length of the implant cannula <NUM> is adjusted. An indicator <NUM> may be used to set the adjustable implant cannula <NUM> to a planned depth. The indicator <NUM> may include a window through the threaded cap <NUM> and a marking that can be aligned to a graduated value, such as between <NUM> and <NUM> in increments of <NUM>. After the depth has been set, the cannula dilator <NUM> may be loaded into the implant cannula <NUM> as shown in <FIG>. The cannula dilator <NUM> may include a cap <NUM> at its proximal end and a distal tip <NUM> configured to expand. The distal tip <NUM> of the cannula dilator <NUM> may be keyed into a corresponding recess <NUM> at the distal end <NUM> of the cannula body <NUM>.

As shown in <FIG>, the adjustable implant cannulas <NUM> may be positioned through the navigation cannulas <NUM>, <NUM>. In <FIG>, each cannula dilator <NUM> is positioned through the implant cannula <NUM>. To assemble, the cap <NUM> of the dilator <NUM> may be impacted until the cap <NUM> hits the face of the navigation cannula <NUM>, <NUM> and the implant cannula <NUM> may simultaneously lock into the navigation cannula <NUM>, <NUM> at the planned depth. The dilators <NUM> may then be expanded to create or enlarge a space in the bone. After the dilators <NUM> are removed, the implant cannulas <NUM> may be used for the discectomy.

Turning now to <FIG>, a navigatable discectomy instrument <NUM> is shown according to one embodiment. The navigatable discectomy instrument <NUM> includes an elongate stationary body <NUM>, an elongate slidable body <NUM> abutting the stationary body <NUM>, a stationary handle <NUM> connected to the stationary body <NUM>, an articulating grip <NUM> pinned to the stationary handle <NUM>, and an articulating distal tip <NUM> configured to cut bone. When the articulating grip <NUM> is squeezed toward the stationary handle <NUM>, the slidable body <NUM> translates longitudinally along the stationary body <NUM> to thereby pivot the articulating tip <NUM> about a pivot pin. <FIG> shows the articulating tip <NUM> in an open extended position and <FIG> shows the articulating grip <NUM> squeezed inwardly to pivot the tip <NUM>, thereby folding the tip <NUM> toward the stationary body <NUM> to cut and remove soft tissue.

The navigatable discectomy instrument <NUM> may include one or more tracking markers <NUM>, <NUM> to track the placement and orientation of the instrument <NUM> and the articulation of the discectomy tip <NUM>. The stationary body <NUM> may support a tracking array <NUM> with a plurality of tracking markers <NUM>, such as spherical passive markers, identified and monitored by the navigation and robotic system <NUM>. In addition, a pivotable arm <NUM> may support a single marker <NUM>, which moves when the articulating grip <NUM> is squeezed. The single marker <NUM> is thus moveable relative to the array <NUM> of stationary markers <NUM>. As shown in <FIG>, the single marker <NUM> has a first position pointing proximally when the articulating tip <NUM> is extended distally. When the grip <NUM> is squeezed and the tip <NUM> is pivoted, the single marker <NUM> pivots to a second position pointing distally as shown in <FIG>. In this manner, the navigation and robotic system <NUM> is able to track placement and articulation of the distal tip <NUM> to confirm soft tissue removal and endplate preparation. This may be used to enhance the discectomy by helping confirm placement and orientation.

As shown in <FIG>, a discectomy may be performed with the discectomy instrument <NUM>. After the implant cannulas <NUM> are inserted and locked axially in the navigated cannulas <NUM>, <NUM>, a discectomy may be performed through both implant cannulas <NUM> to increase the efficiency and overall quality of soft tissue removal. In <FIG>, a pair of discectomy instruments <NUM> are inserted through the implant cannulas <NUM> and into the disc space <NUM> and the articulating tips <NUM> are pivoted to remove soft tissue. The dual discectomy may lead to easier interbody insertion and positioning, and may increase the volume of bone graft in the disc space to promote faster fusion. The discectomy instrumentation <NUM> may utilize navigation to track placement and articulation at the distal tip <NUM> to confirm soft tissue removal and endplate prep in auto-generated volumetric space of the disc.

With emphasis on <FIG> and <FIG>, a powered discectomy instrument <NUM> is shown according to another embodiment. The discectomy instrument <NUM> may be powered, for example, by a motor, to provide for enhanced removal of disc material between the endplates of adjacent vertebrae. The powered discectomy instrument <NUM> may include an articulating soft tissue cutter, curette, or cutting tip <NUM> that may be configured to release both the nucleus pulpous and annulus fibrosus from the inferior and superior endplates of the vertebrae <NUM> simultaneously. As shown in <FIG>, the discectomy instrument <NUM> including cutting tip <NUM> is configured to fit through the implant cannulas <NUM> to access the disc space <NUM>. The cutting tip <NUM> may be articulated to reach around the disc space <NUM>. Although only one implant cannula <NUM> and instrument <NUM> is shown, it will be appreciated that the instrument <NUM> may be used on the contralateral side alone or simultaneously with the ipsilateral side for a bi-portal discectomy.

As shown in <FIG>, the cutting tip <NUM> may include upper and lower endplates <NUM>, <NUM> with a plurality of teeth configured to cut and release disc material. The cutting tip <NUM> of the discectomy instrument <NUM> may be configured for passive expandability. The upper and lower endplates <NUM>, <NUM> may be able to expand away from one another. As the disc material is cut, released, and evacuated, space is created between inferior and superior endplates of the vertebrae <NUM>. One or more spring cuts <NUM> in the cutter <NUM> may allow for the passive expansion. As best seen in <FIG>, the spring cut <NUM> may be bifurcated by a central slit <NUM>, which provides built in clearance for the cutter <NUM> in its collapsed state.

Turning now to <FIG>, a method of inserting and positioning the expandable interbody implant <NUM> is shown according to one embodiment. The interbody implant <NUM> may be positioned into the disc space <NUM> with a first inserter <NUM> by inserting the interbody <NUM> through one implant cannula <NUM>, using a cable <NUM> to fish the lateral leg <NUM> of the implant <NUM> to the opposite implant cannula <NUM>, and connecting the second inserter <NUM> through the opposite implant cannula <NUM>. A cable assembly <NUM> threaded onto one leg <NUM> of the implant <NUM> may use a magnet <NUM> to pull the interbody <NUM> into its natural U-shaped position with the proximal ends of the lateral legs <NUM>, <NUM> connected to inserters <NUM>, <NUM> through the respective implant cannulas <NUM>.

With emphasis on <FIG>, an articulated magnet retrieval and deployment tool <NUM> may be deployed through the contralateral implant cannula <NUM>. The articulated magnet tool <NUM> may be articulated to guide the tool <NUM> toward the ipsilateral implant cannula <NUM>. The articulated magnet tool <NUM> may magnetically attract and connect to a magnetic tip <NUM> of the cable assembly <NUM> positioned through the ipsilateral implant cannula <NUM>. The cable assembly <NUM> includes the magnetic tip <NUM> attached to a fishing cable <NUM>. The fishing cable <NUM> may include a cable, wire, rope, chain, or other suitable line configured to be fished between the implant cannulas <NUM>. The fishing cable <NUM> may have a crimped end at the magnetic tip <NUM>. The opposite end of the fishing cable <NUM> may be coupled to the end of the lateral leg <NUM> of the implant <NUM>. For example, the fishing cable <NUM> may be secured to the implant <NUM> with a proximal threaded cap <NUM>.

As shown in <FIG>, the articulated magnet tool <NUM> is retracted back through the contralateral implant cannula <NUM>, thereby pulling the magnetic tip <NUM> and attached cable <NUM> into the contralateral implant cannula <NUM>. After articulating the magnet retrieval tool <NUM> to connect and pull the crimped end of the cable assembly <NUM> through the contralateral implant cannula <NUM>, the cable <NUM> may be placed under tension as an ipsilateral inserter instrument <NUM> is rigidly connected to the second lateral leg <NUM> of the implant <NUM>.

In <FIG>, the implant <NUM> is fed through the ipsilateral implant cannula <NUM> via inserter <NUM> with the cable assembly <NUM> still attached to the opposite end of the implant. The implant <NUM> articulates at pins <NUM>. As shown in <FIG>, the cable <NUM> may help to pull the interbody <NUM> into its articulated U-shaped position with the lateral legs <NUM>, <NUM> bent at pins <NUM> to increase the overall width or footprint of the implant <NUM>. The threaded cap <NUM> may be aligned to the outlet of the contralateral implant cannula <NUM>. It may be desirable to check the rigidity of inserter connection before unthreading proximal threaded cap <NUM> from the interbody <NUM> to release the cable assembly from interbody <NUM>.

<FIG> shows a view of the inserters <NUM>, <NUM> with the cannulas <NUM> omitted for clarity. The inserters <NUM>, <NUM> may each include an outer sleeve <NUM> with a shaft <NUM> extending therethrough. The terminal end of the shaft <NUM> may provide for threaded engagement with the end of the lateral leg <NUM>, <NUM> of the implant <NUM>. In <FIG>, the threaded sleeve <NUM> and counter torque shaft <NUM> of the second inserter instrument <NUM> is positioned through the contralateral implant cannula <NUM>. In the final configuration shown in <FIG>, the second inserter <NUM> is threaded onto the contralateral leg <NUM> of the implant <NUM> while the first inserter <NUM> is still rigidly connected to the ipsilateral leg <NUM> of the implant <NUM>. This dual connection provides for dual interbody control of the implant <NUM>. Thus, the overall position of the implant <NUM> and each of the lateral legs <NUM>, <NUM> may be manipulated or moved by both inserters <NUM>, <NUM>.

<FIG> shows a complete overview of the bi-portal assembly <NUM> with both navigable inserters <NUM>, <NUM>. The guide bar assembly <NUM> secures the first and second navigated cannula assemblies <NUM>, <NUM> along the desired trajectories. The implant cannulas <NUM> are positioned through the respective navigated cannula assemblies <NUM>, <NUM>. The inserters <NUM>, <NUM> are positioned through the respective implant cannulas <NUM>. Once both inserters <NUM>, <NUM> are connected to the lateral legs <NUM>, <NUM> of the implant <NUM>, navigable arrays <NUM> may be attached to the inserters <NUM>, <NUM> for precise placement of the interbody <NUM>, thereby providing for superior segmental correction and stabilization.

Turning now to <FIG>, once the collapsed interbody implant <NUM> is accurately placed and positioned, drivers <NUM> may be placed through the inserters <NUM>, <NUM> to expand the implant <NUM>. After the handle and array <NUM> of the inserter <NUM>, <NUM> is removed, the drivers <NUM> may be placed down both the ipsilateral and contralateral inserters <NUM>, <NUM> and clipped in axially to the respective inserters <NUM>, <NUM>. The distal tip of each driver <NUM> may interface with the actuation members <NUM> of the implant <NUM> to allow for independent expansion of the lateral legs <NUM>, <NUM> of the implant <NUM>. The handle of the driver <NUM> may be rotated to rotate the actuation member <NUM>, thereby expanding the respective leg <NUM>, <NUM> of the implant <NUM>. Arrays and/or smart instrumentation may be utilized to ensure parallel, lordotic, coronal, or other desired expansion for the implant <NUM>.

Turning now to <FIG> and <FIG>, after the interbody <NUM> is implanted, the pedicle-based intradiscal fixation implants <NUM> may be installed. <FIG> show a rod fixation instrument <NUM> according to one embodiment. The rod fixation instrument <NUM> is configured to load and deploy the rod <NUM> of the pedicle-based intradiscal fixation implant <NUM>. The rod fixation instrument <NUM> may include a body <NUM> with a deployment tube <NUM> at its distal end. The deployment tube <NUM> is straight and configured to draw in the curved rod <NUM>, thereby straightening the rod <NUM> when held within the deployment tube <NUM>. The instrument <NUM> may load the nitinol rod <NUM> into the straight deployment tube <NUM> by drawing the rod <NUM> in from the threaded proximal end <NUM>. The deployment tube <NUM> may be customized for specific size offerings as the bend diameter, or cephalad-caudal height, of the nitinol rod <NUM> may have a proportional rod thickness to improve super elastic properties in proportion to its strength.

The rod fixation instrument <NUM> may include a T-shaped handle <NUM> with a socket <NUM> configured to be received over a shaft <NUM> with an impaction cap <NUM>. The socket <NUM> snaps in drive engagement with button <NUM>. When the handle <NUM> is rotated about the longitudinal axis of the instrument <NUM>, the nitinol rod <NUM> is drawn into the deployment tube <NUM>. The handle <NUM> may be released by snap release of the drive engagement button <NUM>. As shown in <FIG>, after the guide bar assembly <NUM> has been removed from the guide tube <NUM> of the end-effector <NUM>, the nitinol deployment instrument <NUM> is subsequently positioned through the guide tube <NUM> of the end-effector <NUM>. The instrument <NUM> may be locked into the axial locking cap <NUM> by an outer circumferential groove <NUM> in the body <NUM> of the instrument <NUM>.

As shown in <FIG>, the rod fixation instrument <NUM> is set into position for deploying the rod <NUM>. The end-effector <NUM> is set in position after the posterior of the spine is accessed. A hole may be pre-drilled into the pedicle <NUM> of the inferior vertebra <NUM>. The nitinol rod <NUM> may be set into the prepped hole, locked into the end-effector <NUM>, and ready for impaction for deployment.

In <FIG>, the nitinol rod <NUM> is deployed through the inferior vertebral body <NUM>, through the disc space <NUM>, and into the superior vertebral body <NUM>. The shaft <NUM> of the deployment instrument <NUM> may be translated distally along the longitudinal axis of the instrument <NUM>, for example, by striking the impaction cap <NUM> with a surgical mallet. The shaft <NUM> forces the nitinol rod <NUM> to deploy out of the deployment tube <NUM>. The properties of super elastic nitinol allow for the nitinol rod <NUM> to return to its natural, curved state throughout the deployment process, sweeping from the inferior pedicle <NUM>, thru the intradiscal space <NUM>, medially to the lateral interbody legs <NUM>, <NUM>, and into the superior vertebral body <NUM>. After the impaction cap <NUM> bottoms-out, the rod <NUM> is fully deployed, and the deployment instrumentation <NUM> may be removed.

In <FIG>, the pedicle screw <NUM> is secured and anchored to the nitinol rod <NUM>. A driver <NUM> positioned through guide tube <NUM> inserts the pedicle screw into the inferior pedicle <NUM>. The pedicle screw <NUM> is inserted and driven over the proximal threads <NUM> of the nitinol rod <NUM> to purchase the existing cortical bone in the pedicle <NUM> and anchor the proximal end <NUM> of the nitinol rod <NUM> to the inferior pedicle <NUM>. The process shown in <FIG> may then be repeated for the second intradiscal fixation implant <NUM> on the contralateral side.

<FIG> show an example of the completed construct <NUM> including the interbody implant <NUM> and two intradiscal implants <NUM>. <FIG> provides a posterior view of the spine and the two intradiscal implants <NUM> positioned into the pedicles <NUM> of the inferior vertebra <NUM>. <FIG> shows a lateral view of the spine with the interbody implant <NUM> positioned in the disc space <NUM> between the vertebrae <NUM>. <FIG> shows an anterior view of the spine and the interbody implant <NUM>. <FIG> is an intradiscal view of the system <NUM> including the interbody implant <NUM> and two intradiscal implants <NUM>. The completed construct <NUM> provides superior stabilization from a posterior approach. The intradiscal implants <NUM> do not violate the superior facet joint, limiting adjacent segment disease that can be a result of superior adjacent facet violation.

According to one embodiment, the procedure may be performed with navigation and/or robotic assistance. The robotically-enabled procedure may include a workflow assisted and enhanced using imaging, navigation and robotics including: (<NUM>) pre-operative planning; (<NUM>) end-effector set-up; (<NUM>) tubular access and decompression or alternative visualization port workflows; (<NUM>) bi-portal implant cannula insertion; (<NUM>) bi-portal discectomy; (<NUM>) interbody deployment, positioning, and expansion; (<NUM>) nitinol fixation construction; and (<NUM>) final verification. The robotically-enabled procedure may utilize imaging, navigation, and robotics to enhance the quality and efficiency of the posterior procedure through planning and navigable instrumentation.

The first step in the workflow may include pre-operative planning. The importance of a structured workflow for the robotically-enabled bi-portal interbody fusion technique is stressed in pre-operative imaging and planning stages. A step-by-step user interface may be provided on the monitor <NUM> of the robot <NUM> to walk healthcare professionals through precise interbody placement, depth-controlled access-decompression instrumentation, and fixation planned deployment. The control of these aspects may be enhanced with sagittal, axial, coronal, and 3D volumetric views of patient anatomy with the addition of CT-MRI merge displays to recognize and visualize neural elements for safe and repeatable procedures.

The planning stage may follow a detailed checklist. After selecting the level to be corrected on the monitor <NUM>, a virtual representation of the anterior or center leg <NUM> of the <NUM>-legged interbody implant <NUM> may be placed along the anterior side of the apophyseal ring on midline. This interbody <NUM> has dual, independent expansion and angulation on the lateral legs <NUM>, <NUM>. The interbody <NUM> may utilize bi-portal access into the disc space <NUM> based of the width of the anterior leg <NUM> and angulation and length of the lateral legs <NUM>, <NUM>. Angulation of lateral legs <NUM>, <NUM> may be controlled on the transverse plane on the planned level, shifting from medial to lateral. Parallel and lordotic expansion of the lateral legs <NUM>, <NUM> may be planned prior to the procedure either independently or mirrored to one another. All sizing, positioning, and expansion of the interbody footprint are to help customize the correction to patient anatomy.

Once the planned anterior width and leg angulation are set, a surgeon may plan for the removal of posterior bone anatomy to gain access into the disc space <NUM>. For example, pre-planned depth stops may be used for access instrumentation on the given trajectory. In one embodiment, stops <NUM>, <NUM> may be set to protect neural anatomy from powered instrumentation. The planned implant cannula depth may be set independently in relation to the proximal ends of the left and right lateral legs <NUM>, <NUM> of the interbody <NUM>.

The final stage in the pre-op planning checklist is to plan the nitinol fixation implants <NUM> with regards to trajectory, rod sizing, and pedicle screw sizing. The nitinol fixation implant <NUM> may be set medially to the lateral legs <NUM>, <NUM> and posteriorly to the anterior leg <NUM> of the interbody <NUM>. Size offerings are determined based on which bend diameter fits within the inferior and superior vertebral bodies <NUM> without violating the facet or damaging the axis of the pedicle <NUM> of the superior vertebra <NUM>. Pedicle screws <NUM> may be sized to ensure the capture of the proximal end <NUM> of the nitinol rod <NUM> with the screw <NUM> while the screw head <NUM> is protruding from the pedicle <NUM>.

The second step in the workflow may include end-effector manual set-up. Once the pre-op plan summary is complete, the guide bar assembly <NUM> may be introduced to the end-effector <NUM> to introduce single position, bi-portal control. The axial locking cap <NUM> may be snapped on an inside portion of the end-effector <NUM> to avoid blocking the infrared LEDs <NUM>. The guide bar <NUM> may be slid through the inner diameter of the guide tube <NUM> of the end-effector <NUM> to lock the assembly axially with the end-effector height. In an alternative design, the connection to the robot <NUM> could be built into the guide bar <NUM> rather connecting through the end-effector <NUM>.

Once the guide bar <NUM> snaps in and locks axially, the assembly <NUM> may be rotated about the end-effector <NUM> until the planned levels plane is parallel with the navigated cannulas <NUM>, <NUM>. Markers <NUM> are identified by the camera system <NUM> to callout the degrees off the plane, and the guide bar <NUM> may be final locked when the callout is at <NUM>°. Following rotationally locking the guide bar <NUM>, the width of the guide bar assembly <NUM> may be manually adjusted to match the anterior legs width and then angles of the navigated cannulas <NUM>, <NUM> may be adjusted to be consistent with the pre-op plan, sizing, and positioning. Axis of the navigated cannula <NUM>, <NUM> may line up with the medial-lateral angle of the lateral leg <NUM>, <NUM> found in the plan summary. The navigated cannulas <NUM>, <NUM> may be final locked to ensure guide bar and nav cannula rigidity before moving forward to depth control.

Working with an outside-in approach, access-decompression may begin to remove the bilateral facet joints. Safety and protective precautions may be taken for exiting neural elements, for example, by setting the adjustable stop <NUM>, <NUM> to its initial depth. Depth control may be set according to plan and remains independent on the left and right trajectories for customized access for abnormal patient anatomy. An alternative design to this manual set-up is providing power to a single position, bi-portal end-effector that can auto-generate the width, angulation, and adjustable depth control settings according to the pre-operative plan.

The third step in the workflow may include tubular access and decompression or alternative direct visualization ports. There remains variability in surgeons' comfort with the tubular approach in comparison to direct visualization while removing posterior structural anatomy and protecting neural elements anteriorly to the facet joint. To accommodate, alternative workflow consisting of direct visualization ports <NUM> can be utilized with the guide bar system <NUM> in addition to the tubular access and decompression workflow. Hybrid use of high-speed burrs, oscillating drills, and manual osteotome instrumentation may be utilized to enhance comfort for surgeons from different technical backgrounds and training. Alternative workflows keep the same trajectory planned with benefits provided with each workflow.

The MIS access workflow with the navigated cannulas <NUM>, <NUM> provides tubular access and decompression benefits including: (<NUM>) depth control compatibility; (<NUM>) navigated cannula compatibility with dilator, off-center sheath, docking facet dilator, and instrumentation; (<NUM>) reduced amount of posterior structural anatomy; and (<NUM>) streamlined to insert interbody cannula immediately. The direct visualization access workflow with ports <NUM> may have conical angulation. The direct visualization may provide for increased visualization for thorough decompression and increased visualization may increase safety with regards to neural elements.

The fourth step in the workflow may include bi-portal implant cannula insertion. After a thorough access and decompression have sufficiently removed all obstructing bone from the bilateral trajectories, regardless of access workflow used, navigated cannulas <NUM>, <NUM> may be used with the adjustable stop <NUM>, <NUM> locked into its lowest height for implant cannula insertion. Implant cannula <NUM> may be adjusted to planned depth according to plan, and then cannula dilator <NUM> may be loaded into the keyed feature <NUM> at the distal tip <NUM> of the cannula <NUM>. The proximal end of cannula dilator <NUM> may be impacted until the cap <NUM> hits the face of the navigated cannula <NUM>, <NUM>, and implant cannula <NUM> simultaneously locks into the navigated cannula <NUM>, <NUM> at the planned depth. The cannula dilator <NUM> may be removed to begin the discectomy.

The fifth step in the workflow may include the discectomy. Once both implant cannulas <NUM> are inserted and locked axially, a discectomy may be performed through both implant cannulas <NUM> to increase the efficiency and overall quality of soft tissue removal. This may lead to easier interbody insertion, positioning and increase the volume of bone graft in the disc space to promote faster fusion. A heat map may be automatically generated based on interbody placement to calculate a volumetric area where tools can and should be placed to remove soft tissue.

Discectomy instrumentation <NUM> may utilize navigation to track placement and articulation at the distal tip <NUM> to confirm soft tissue removal and endplate prep in auto-generated volumetric space of the disc. The array sphere <NUM> may track the mechanical articulation according to the customized array positioning. This may enhance the discectomy by helping confirm placement and orientation. The robot <NUM> may also read out areas in which a tool path has or has not passed through to ensure sufficient soft tissue removal and surface area of endplates have been prepped.

Bi-portal navigated discectomy may have variability in technique allowing for surgeon preference to select between navigated manual instrumentation <NUM>, powered discectomy instrumentation <NUM>, or a hybrid use of both. Both technique workflows may be completed with manual endplate prep instrumentation to help ensure increased fusion rates and to verify the passing of instrumentation throughout the auto-generated volumetric heat map.

The sixth step in the workflow may include interbody deployment and positioning. After a thorough discectomy is completed, the <NUM>-legged interbody <NUM> may be positioned by inserting the interbody <NUM> through the ipsilateral implant cannula <NUM>, using a cable <NUM> to fish the contralateral lateral leg <NUM> to the contralateral implant cannula <NUM>, and connecting the second inserter <NUM> through the contralateral implant cannula <NUM>. Utilizing two hinge pins <NUM> to connect the three legs <NUM>, <NUM>, <NUM> and a cable assembly <NUM> threaded onto the contralateral leg <NUM>, a magnet pulls the interbody <NUM> into its natural U-shaped position with the proximal ends of the lateral legs <NUM>, <NUM> connected to inserters <NUM>, <NUM> through the implant cannula <NUM>.

After articulating the magnet retrieval tool <NUM> to connect and pull the crimped end of the cable assembly <NUM> through the contralateral implant cannula <NUM>, the cable <NUM> may be placed under tension as the contralateral inserter <NUM> is rigidly connected to the lateral leg <NUM>. Rigidity of inserter connection may be checked before unthreading the proximal threaded cap <NUM> from the interbody <NUM> to release the cable assembly <NUM> from the interbody <NUM>.

Once both inserters <NUM>, <NUM> are connected to the lateral legs <NUM>, <NUM>, navigable arrays <NUM> may be attached to the inserters <NUM>, <NUM> for precise placement of the interbody <NUM> for superior segmental correction and stabilization. Views from the sagittal, axial, and coronal planes as well as a 3D volumetric view may enhance a surgeon's ability to place the interbody <NUM> in the planned position with dual inserter control. Trajectories may be locked as a result of the pre-op plan and guide bar set-up, but depth and orientation of the anterior and lateral legs <NUM>, <NUM> may be confirmed using navigation prior to expansion.

Once the collapsed interbody <NUM> is accurately placed, drivers <NUM> may be placed down both the ipsilateral and contralateral inserters <NUM>, <NUM> and clipped in axially to the respective inserters <NUM>, <NUM>. Arrays and/or smart instrumentation may be utilized to read-out both parallel, followed by lordotic, expansion for both the left and right sides individually. Same as the rest of the procedure, the planned summary may list the expandable implant's target height, lordotic, and coronal correction.

The seventh step in the workflow may include installing the nitinol fixation assembly <NUM>. As a result of superior segmental correction from the interbody stabilization device <NUM> with increased cortical bone on the apophyseal ring contact with interbody endplates, inferior pedicle-based intradiscal fixation devices <NUM> may be deployed medially to the lateral legs <NUM>, <NUM> of interbody plan. The super elasticity of nitinol allows for the material to be drawn into the straight deployment tube <NUM> from its curved state. The instrument <NUM> is able to load the nitinol into the straight deployment tube <NUM> by drawing it in from the threaded proximal end <NUM>. The deployment tube <NUM> is customized for specific size offerings as the bend diameter, or cephalad-caudal height, of the nitinol rod <NUM> has a proportional rod thickness to improve super elastic properties in proportion to its strength.

Before shifting the end-effector <NUM> onto the planned trajectory for fixation deployment, navigation may prompt the surgeon to re-register with a sagittal and coronal c-arm shot to account for the segmental correction and a shift of inferior and superior vertebrae <NUM> from interbody expansion. Once re-registered, the pre-op plan for nitinol fixation <NUM> may be confirmed and/or altered to fit revised patient anatomy. Once the plan is set, the end-effector <NUM> moves into position and a powered pedicle prep drill may be used to drill a hole to the planned depth of the deployment instrumentation <NUM> into the inferior pedicle <NUM>. The nitinol deployment instrument <NUM> is subsequently sent down the end-effector <NUM> and locked into the axial locking cap <NUM> after the guide bar assembly <NUM> has been removed.

The nitinol rod <NUM> may be set into the prepped hole, locked into the end-effector <NUM>, and is ready for impaction for deployment. The properties of super elastic nitinol allow for the nitinol to return to its natural, curved state throughout the deployment process, sweeping from the inferior pedicle <NUM>, thru the intradiscal space <NUM>, medially to the lateral interbody legs <NUM>, <NUM>, and into the superior vertebral body <NUM>. After the impaction cap <NUM> bottoms-out and the rod <NUM> is fully deployed, the instrumentation <NUM> may be removed. The pedicle screw <NUM> may be inserted and driven over the proximal threads <NUM> of the nitinol rod <NUM> to purchase the existing cortical bone in the pedicle <NUM> and anchor the proximal end <NUM> of the nitinol rod <NUM> to the inferior pedicle <NUM>. Additional features may be used to lock the screw <NUM> to the nitinol rod <NUM>, such as a snap ring in the pedicle screw <NUM> to snap into an external groove of the nitinol rod <NUM>. The process of installing the second nitinol fixation assembly <NUM> may be repeated for the contralateral side.

The eighth step in the workflow may include final verification. After fixation <NUM> is deployed and assembled, a final verification may be used to ensure the final construct accomplished the pre-op plan targeted positions, and achieved segmental correction in the sagittal and coronal planes. The completed construct provides superior stabilization from a posterior approach and the fixation devices <NUM> do not violate the superior facet joint, thereby limiting adjacent segment disease.

The robotically-enabled procedure utilizes imaging, navigation, and robotics to enhance the quality and efficiency of the posterior procedure through planning and navigable instrumentation. The overall procedure may reduce radiation exposure compared to traditional surgeries. The bi-portal assembly and discectomy instruments provide for safe and repeatable direct decompression within the access window of the tubular approach. The discectomy instrumentation may increase the percent volume of soft tissue removed to increase volumetric area for interbody placement and bone graft. Segmental correction from the interbody stabilization device with independently controlled sagittal and coronal correction may provide for increased stability from increased endplate contact along the apophyseal ring. The posterior, MIS nitinol fixation implants avoid violation of superior facet joint and the potential iatrogenic effects bilateral pedicle constructs can cause.

Claim 1:
A bi-portal robotically-enabled system comprising:
- a robotic system (<NUM>) comprising a base (<NUM>), including a computer, a display (<NUM>) electronically coupled to the computer, a robot arm (<NUM>) electronically coupled to the computer and movable based on commands processed by the computer,
- an end-effector (<NUM>) including a guide tube (<NUM>) electronically coupled to the robot arm (<NUM>) so that the surgical robot (<NUM>) is able to control the translation and orientation of the end-effector (<NUM>), the guide tube (<NUM>) having a central longitudinal axis, and a camera (<NUM>) configured to detect one or more tracking markers; and characterized in that the system comprises
- a bi-portal assembly (<NUM>) configured to attach to the guide tube (<NUM>) of the end-effector (<NUM>) of so that the robotic system (<NUM>) is configured to control the location and orientation of the bi-portal assembly (<NUM>) relative to the surgical area
- the bi-portal assembly (<NUM>) configured to pivot or rotate about the central longitudinal axis (A) of the guide tube (<NUM>) of the end-effector (<NUM>) and comprising a guide bar (<NUM>) assembly (<NUM>) supporting first and second navigated cannula assemblies (<NUM>, <NUM>),
- the guide bar assembly (<NUM>) includes a central guide bar (<NUM>) configured to be inserted into the guide tube (<NUM>), a central support arm (<NUM>) for holding first and second lateral wings (<NUM>, <NUM>) positioned on opposite sides of the guide bar (<NUM>) and extending outwardly in opposite directions from one another,
- the first and second navigated cannula assemblies (<NUM>, <NUM>) each include a hollow tubular cannula (<NUM>, <NUM>) configured to guide an instrument placed through the respective cannula (<NUM>, <NUM>) along a desired access trajectory to a surgical area, wherein the first and second lateral wings (<NUM>, <NUM>) support the hollow tubular cannula (<NUM>, <NUM>) via a first and a second supporting arms (<NUM>, <NUM>),
- and wherein the first and second navigated cannula assemblies (<NUM>, <NUM>) are each configured to independently angulate with respect to the central longitudinal axis (A) of the guide tube (<NUM>), thereby providing the desired access trajectories to the surgical area.