Intervertebral lumbar interbody fusion system and associated robotic system

Abstract

Orthopedic implants, systems, instruments, and methods are disclosed. A dual gate lumbar interbody fusion system can include an expandable interbody implant and a minimally invasive pedicle-based intradiscal fixation implant. The interbody implant and the intradiscal implant can be installed with intelligent instruments capable of repeatably providing accurate placement of the implants. The dual gate system can be robotically enabled to guide the instruments and implants along a desired entry trajectory to a surgical region.

Description

Technical Field

[0001] This application relates in general to orthopedic fixation devices, such as, for example, lumbar interbody fusion implants, intervertebral disc implants, related instruments and related methods for spinal surgery. Background Technology

[0002] Transforaminal lumbar interbody fusion (TLIF) is a standard surgical technique used to provide support and stabilize the vertebral and intervertebral disc spaces in the treatment of various spinal conditions, such as degenerative disc disease and spinal stenosis with anterior vertebral displacement. Clinical treatment of spinal pathology may involve precise placement of the intervertebral body to restore anterior column alignment with bilateral pedicle screw (BPS) fixation, stabilizing two or more adjacent vertebral bodies at the level of spinal fusion.

[0003] Various iatrogenic pathologies can occur with intervertebral body and bilateral pedicle screw placement. These pathologies may result from surgical access to the intervertebral disc space, inability to precisely position the intervertebral body along the annulus ossicularis for high-quality cortical bone support, and / or inability to restore normal anatomical spinal alignment. Iatrogenic pathologies associated with pedicle screw fixation may include, but are not limited to, screw misalignment, muscle / ligament rupture during insertion, adjacent segmental disease due to damage to the superior adjacent facet caused by the pedicle screw, and rod construction, procedural inefficiency, and instrument malfunction.

[0004] The instruments required for tubular access to the intervertebral disc provide valuable decompression, effectively enabling high-quality discectomy. Insertion and deployment of the intervertebral body, along with the insertion of pedicle screws and rod structures, also require extensive radiographic imaging throughout the procedure. All of these factors increase surgical time, radiation exposure, and may lead to implant and screw displacement.

[0005] There is a clinical need for robot-enabled procedures that provide preoperative planning compatible with navigational smart devices that (1) establish safe and repeatable direct decompression upon access to the intervertebral disc space; (2) provide enhanced navigational electric discectomy techniques; (3) allow for precise placement of expandable intervertebral bodies that increase surface area contact along the annulus ossicularis via a posterior approach; and / or (4) utilize minimally invasive fixation methods to stabilize adjacent vertebral bodies without damaging the superior facet. Summary of the Invention

[0006] To meet this and other needs, orthopedic implants, systems, devices, and methods are provided. Implant systems may include three-legged expandable intervertebral bodies for use alone or in combination with one or more pedicle-based intervertebral disc fixation implants. Implants may be installed using a robot-enabled double-gate lumbar intervertebral body fusion procedure, in which intelligent devices are capable of repeatedly providing clinically superior segmental correction through stabilization and fixation methods that avoid damage to the superior adjacent facet joints in patients with grade I or II degenerative disease. The procedure may include one or more aspects of the following workflows, which may be aided and enhanced by imaging, navigation, and / or robotics: (1) preoperative planning; (2) end effector setup; (3) tubular access and decompression or alternative visualization port workflows; (4) double-gate implant cannulation; (5) double-gate discectomy; (6) intervertebral body deployment, positioning, and expansion; (7) nitinol fixation construction; and (8) final validation.

[0007] According to one embodiment, an orthopedic system for stabilizing the spine includes an expandable intervertebral body implant, a first pedicle-based intradiscal implant, and a second pedicle-based intradiscal implant. The expandable intervertebral body implant may include a first expandable lateral leg, a second expandable lateral leg, and a third central leg pivotally connected between the first and second lateral legs. The first and second lateral legs may be independently extended in height to provide lordosis and / or coronal adjustment. The first and second pedicle-based intradiscal implants may each include a nitinol rod and a pedicle screw for fixation to the nitinol rod.

[0008] Pedicle-based intradiscal implants may include one or more of the following features: A nitinol rod may extend from a proximal end configured to mate with a pedicle screw to a distal end configured to engage bone. The nitinol rod may have a natural curvature and may be straightened for deployment. The curvature of the nitinol rod may be an arc of up to 180°. The nitinol rod may have a polygonal cross-section with a planar surface. The nitinol rod may be configured to be inserted through the pedicle of a lower vertebra, through the vertebral body of the lower vertebra, through the intervertebral disc space, and into the vertebral body of an upper vertebra. The proximal end of the nitinol rod may include an external threaded portion configured to mate with an internal threaded portion of the pedicle screw. The pedicle screw may include a screw head having a threaded or roughened texture configured to engage with a multiaxial tuliphead.

[0009] An expandable intervertebral body implant may include one or more of the following features. A first lateral leg and a second lateral leg of the expandable intervertebral body implant may be configured to angle at one or more pins to increase the overall footprint of the implant. Each of the first and second lateral legs may include an actuation assembly comprising a drive screw configured to extend the first and second lateral legs and the central leg of the expandable intervertebral body implant.

[0010] According to one embodiment, a pedicle-based intradiscal implant includes a flexible rod and a pedicle screw. The flexible rod may be made of a shape memory material such as nitinol. The flexible rod extends from a proximal end having an external threaded portion to a distal end having a sharp tip configured to engage bone. The flexible rod may have a polygonal cross-section with a planar surface. The pedicle screw extends from a proximal end having a screw head to a distal end having a tip configured to engage the tip of the flexible rod. The pedicle screw may have a threaded shaft with a hollow body for receiving the proximal end of the flexible rod. The threaded shaft may define an internal threaded portion configured to mate with the external threaded portion of the flexible rod.

[0011] According to another embodiment, a system for deploying a pedicle-based intradiscal implant includes a deployment device configured to load and deploy a bendable rod. The deployment device includes a body having a longitudinal axis, the body comprising: a straight deployment tube configured to introduce the bendable rod, thereby straightening the rod when it is held within the deployment tube; and a shaft having a clamping cap. The deployment device may include a T-shaped handle having a socket configured to receive on the shaft having the clamping cap. When the handle is rotated about the longitudinal axis of the deployment device, the bendable rod is drawn into the deployment tube. When the shaft of the deployment device is translated distally along the longitudinal axis of the device by striking the clamping cap, the shaft forces the bendable rod outwardly deployed from the deployment tube.

[0012] According to another embodiment, a method for stabilizing the spine includes: (1) positioning an expandable intervertebral body implant in an intervertebral disc space between a superior vertebra and a inferior vertebra, the expandable intervertebral body implant having three articulated and expandable legs; (2) deploying a first flexible rod from the ipsilateral pedicle of the inferior vertebra, through the intervertebral disc space, and into the vertebral body of the superior vertebra; (3) inserting a first pedicle screw through the ipsilateral pedicle of the inferior vertebra and driving the first pedicle screw over the first flexible rod to anchor the first flexible rod; (4) deploying a second flexible rod from the contralateral pedicle of the inferior pedicle, through the intervertebral disc space, and into the vertebral body of the superior vertebra; and (5) inserting a second pedicle screw through the contralateral pedicle of the inferior pedicle and driving the second pedicle screw over the second flexible rod to anchor the second flexible rod.

[0013] The method may further include: three legs of an expandable intervertebral body implant hinged relative to each other to increase the overall footprint of the implant. The expandable intervertebral body implant can be positioned along the bony annulus of the vertebra for cortical bone support. The expandable intervertebral body implant can be expanded to independently control sagittal and coronal alignment. The expandable intervertebral body implant can be positioned in the intervertebral disc space by: inserting a magnetic cable assembly attached to the expandable intervertebral body implant through an ipsilateral cannula; inserting a hinged magnetic retrieval tool through a contralateral cannula to magnetically attract and connect to the magnetic cable assembly; and retracting the hinged magnetic retrieval tool through the contralateral cannula, thereby pulling the cable assembly into the contralateral cannula and positioning the expandable intervertebral body implant in the intervertebral disc space. A first intradiscal implant can be deployed through the ipsilateral cannula, and a second intradiscal implant can be deployed through the contralateral cannula. The first and second intradiscal implants can be centrally positioned relative to the expandable intervertebral body implant. The first and second bendable bars can each be deployed using a deployment device having a deployment tube and a clamping cap. Each bendable bar can be deployed by impacting the clamping cap, thereby forcing the bar outward from the deployment tube.

[0014] According to another embodiment, a method for installing an expandable intervertebral body implant in the intervertebral disc space between two adjacent vertebrae may include: (1) inserting a cable assembly through an ipsilateral cannula, the cable assembly including a cable having a magnetic tip at one end and being attachable to an expandable intervertebral body implant at the other end, the expandable intervertebral body implant having a first expandable lateral leg, a second expandable lateral leg, and a third central leg pivotally connected between the first lateral leg and the second lateral leg; (2) inserting a hinged magnet retrieval tool through a contralateral cannula; (3) hinged and guided the hinged magnet retrieval tool toward the ipsilateral cannula to magnetically attract and attach to the magnetic tip of the cable assembly; and (4) retracting the hinged magnet retrieval tool through the contralateral cannula, thereby pulling the cable assembly into the contralateral cannula and positioning the expandable intervertebral body implant in the intervertebral disc space.

[0015] A method for installing an expandable intervertebral body implant may further include: threading a cable assembly onto a first expandable lateral leg of the expandable intervertebral body implant, and then inserting the cable assembly through an ipsilateral cannula. The method may include: attaching a first insert to the expandable intervertebral body implant while the cable is placed under tension. The method may include: feeding the expandable intervertebral body implant through the ipsilateral cannula using the first insert while the cable assembly pulls the expandable intervertebral body implant into an articulated U-shaped position. After the cable assembly is removed from the expandable intervertebral body implant, a second insert may be attached to the expandable intervertebral body implant such that the first insert and the second insert are rigidly connected to the first lateral leg and the second lateral leg, respectively, thereby providing dual control of the expandable intervertebral body implant. The method may further include: inserting an actuator through each of the first and second inserts to independently expand the first and second lateral legs to control sagittal and coronal alignment.

[0016] According to another embodiment, a method for installing a pedicle-based intradiscal implant may include: (1) loading a deployment device by drawing a rod having a naturally curved shape into a straight deployment tube, the deployment device comprising a body having a longitudinal axis, the body having a straight deployment tube and an axis having a clamping cap, thereby straightening the rod when it is held within the deployment tube; (2) positioning the deployment tube at the pedicle of a lower vertebra; and (3) deploying the rod from the deployment device by striking the clamping cap to translate the axis of the deployment device along the longitudinal axis, thereby forcing the rod to be deployed outward from the deployment tube, wherein once deployed, the rod extends from the pedicle, through the intervertebral disc space and into the vertebral body of a higher vertebra. The method for installing a pedicle-based intradiscal implant may further include: fixing a pedicle screw through the pedicle of a lower vertebra and driving the pedicle screw over one end of the rod to anchor the rod.

[0017] According to another embodiment, a dual-door robot-enabled system may include a robot system and a dual-door assembly. The robot system may include: a base including a computer; a display electrically coupled to the computer; a robot arm electrically coupled to the computer and movable based on commands processed by the computer; an end effector having a guide tube electrically 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 dual-door assembly may include a guide rod assembly supporting a first navigation cannula assembly and a second navigation cannula assembly. The guide rod assembly may include: a central guide rod configured to insert into the guide tube; and a first lateral wing and a second lateral wing positioned on opposite sides of the guide rod. The first and second navigation 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.

[0018] The dual-door robot-enabled system may include one or more of the following features. The dual-door assembly may be configured to pivot about the central longitudinal axis of the guide tube of the end effector. A first navigation cannula assembly and a second navigation cannula assembly may each be configured to be independently angled relative to the central longitudinal axis of the guide tube, thereby providing a desired access trajectory to the surgical area. The width between the cannulas of the first and second navigation cannula assemblies may be adjustable. The dual-door assembly may include a plurality of tracking markers configured to monitor the guide rod assembly and the first and second navigation cannula assemblies, thereby providing navigation and / or robot assistance. A first lateral wing may support the first navigation cannula via a first support arm, and a second lateral wing may support the second navigation cannula via a second support arm. The first and second lateral wings may each include an elongated slot, and the navigation cannula assembly may slide along the respective slot to adjust the cannula width and / or angle. The guide rod may be configured to slide into the guide tube of the end effector and be axially locked to the guide tube using an axial locking cap. The axial locking cover may include a locking button configured to engage with a recess on the guide rod. Rotational movement of the guide rod assembly may be locked using a center wheel handle lock.

[0019] According to another embodiment, a dual-door assembly may include a guide rod assembly and a first navigation sleeve assembly and a second navigation sleeve assembly. The guide rod assembly may include: a central guide rod configured to insert into a guide tube of a robotic system; and a first lateral wing and a second lateral wing positioned on opposite sides of the guide rod. The first and second lateral wings may each include an elongated slot. The first navigation sleeve assembly may include a first sleeve coupled to the first lateral wing. The first sleeve may be configured to guide an instrument placed through the first sleeve along a first entry trajectory. The second navigation sleeve assembly may include a second sleeve coupled to a second lateral wing. The second sleeve may be configured to guide an instrument placed through the second sleeve along a second entry trajectory. The first and second navigation sleeve assemblies may slide along corresponding slots in the first and second lateral wings to adjust the width and / or angle of the first and second sleeves.

[0020] The dual-door assembly may include one or more of the following features. A first navigation sleeve assembly and a second navigation sleeve assembly are movable along one or more ratchet wheels, thereby providing incremental adjustment of the width and / or angle of the first and second sleeves. The ratchet wheels may include swivel ratchet wheels configured to mimic the shape of the first and second lateral wings. The ratchet wheels may be positioned above and below each elongated slot in an elongated slot. The first and second navigation sleeve assemblies may each include a rotatable knob configured to independently lock the final position of the first and second sleeves. The dual-door assembly may include multiple tracking marks located on the guide rod, the first and second lateral wings, and the first and second sleeves.

[0021] According to another embodiment, a method for enabling a dual-gate robot may include: (1) performing a preoperative plan using a robotic system with an end effector having a guide tube, the preoperative plan including taking preoperative images and planning the positioning of one or more implants; (2) introducing a guide rod of a dual-gate assembly into the guide tube of the end effector, the dual-gate assembly including a guide rod assembly supporting a first navigation cannula assembly and a second navigation cannula assembly, the first navigation cannula assembly and the second navigation cannula assembly each configured to guide the device along a desired entry trajectory; (3) entering the surgical site through the first navigation cannula assembly and the second navigation cannula assembly to perform decompression; (4) positioning the implant cannula through the first navigation cannula assembly and the second navigation cannula assembly; (5) performing a discectomy through the implant cannula; (6) deploying an intervertebral body implant through the implant cannula; (7) installing an intradiscal implant through the guide tube of the end effector; and (8) verifying the final positioning of the intervertebral body implant and the intradiscal implant. The first and second navigation cannula assemblies may each include an adjustable depth stop configured to be set at an entry depth into the surgical site.

[0022] Kits are also available, which include implants of different types and sizes, rods, fasteners or anchors, various instruments and tools, Kirschner wires, and other components for performing procedures. Attached Figure Description

[0023] A more complete understanding of the invention, along with its accompanying advantages and features, will be readily apparent when considered in conjunction with the accompanying drawings, by referring to the following detailed description, in which:

[0024] Figures 1A to 1C Anterior, lateral and axial views of adjacent vertebrae using a fixation system according to one embodiment are shown, the fixation system including a three-legged expandable intervertebral body and a pair of pedicle-based intervertebral disc fixation implants;

[0025] Figures 2A to 2D A top view, a rear view, and a side view of a three-legged expandable intervertebral body implant according to one embodiment are shown respectively;

[0026] Figure 3 A perspective view of a pedicle-based intervertebral disc fixation implant according to one embodiment is shown;

[0027] Figures 4A to 4B They are shown respectively Figure 3 Components of pedicle-based intervertebral disc fixation implants, including nitinol rods and pedicle screws coupled to the nitinol rods;

[0028] Figure 5This is a flowchart of the workflow for a bi-door lumbar interbody fusion procedure based on an implementation plan;

[0029] Figures 6A to 6B A robotic surgical system including an end effector with a guide tube is described according to one embodiment;

[0030] Figure 7 The acceptance according to one implementation scheme is shown. Figure 6B A perspective view of the robot-enabled dual-door rear access assembly in the guide tube of the end effector;

[0031] Figures 8A to 8C A method is shown according to one embodiment of attaching a guide rod assembly of a double-door assembly to a guide tube of an end effector, rotating the double-door assembly, and aligning the double-door assembly to access the spine;

[0032] Figures 9A to 9B A rear view of a dual-door assembly according to one embodiment is depicted, showing the adjustment of the cannula's width and angle for mounting an expandable intervertebral body implant.

[0033] Figure 10 A front view of a double-door assembly with an adjustable stop for controlling the entry depth of an instrument through a cannula, according to one embodiment, is shown.

[0034] Figures 11A to 11B Front and side views of a dual-door assembly according to one embodiment are shown, in which a navigation device is positioned through a cannula to enter the intervertebral disc space;

[0035] Figures 12A to 12B Front and side views of a dual-door assembly according to one embodiment are shown, wherein an alternative instrument is positioned through a cannula to enter the intervertebral disc space;

[0036] Figures 13A to 13C A port assembly connected to a guide rod assembly is shown according to one embodiment, wherein the width and angle between the ports, the taper angle of the ports, and the depth of the ports can be adjusted to increase visualization of the surgical site;

[0037] Figures 14A to 14D An exploded view and an assembled view of a navigation device assembly having an adjustable stop for controlling the depth of entry, according to one embodiment, are shown.

[0038] Figures 15A to 15C An adjustable implant cannula and a cannula dilator loaded in the implant cannula are shown according to one embodiment;

[0039] Figures 16A to 16B A dual-gate assembly with an adjustable implant cannula and a cannula dilator is shown according to one embodiment;

[0040] Figures 17A to 17B A navigational discectomy device according to one embodiment is shown;

[0041] Figures 18A to 18C A guided discectomy procedure via a dual-gate assembly with an adjustable implant cannula is illustrated according to one embodiment;

[0042] Figures 19A to 19B A discectomy procedure using an electric discectomy device is shown according to another embodiment;

[0043] Figures 20A to 20C A perspective view, a side view, and a front view of a tissue cutter for an electric discectomy instrument according to one embodiment are shown respectively.

[0044] Figures 21A to 21F The illustration shows a method for utilizing a magnetic retrieval and deployment tool and a traction cable assembly according to one embodiment. Figures 2A to 2D A method for installing articulated, expandable implants in the intervertebral disc space;

[0045] Figure 22 A complete overview of a dual-gate assembly with a navigable insert positioned through ipsilateral and contralateral implant cannulas is shown according to one embodiment;

[0046] Figures 23A to 23B Front and perspective views of a double-door assembly having snap-fit ​​inserts on the same side and opposite side, according to one embodiment, are shown respectively;

[0047] Figures 24A to 24C A nitinol rod fixation device is shown, which is configured for loading and deployment. Figure 3 and Figures 4A to 4B The nitinol rod shown is a pedicle-based intervertebral disc fixation implant.

[0048] Figures 25A to 25F A system and method for deploying a nitinol fixation rod and attaching pedicle screws to the rod, according to one embodiment, are shown; and

[0049] Figures 26A to 26D Rear view, side view, front view and internal disc view of the final configuration including an expandable intervertebral body implant and two intervertebral disc fixation devices according to one embodiment are shown respectively. Detailed Implementation

[0050] The embodiments disclosed herein relate generally to orthopedic implants, systems, devices, and methods. Specifically, a double-door lumbar interbody fusion procedure may include: an expandable interbody that increases surface area contact along the annulus fibrosus via a posterior approach; and minimally invasive pedicle-based disc fixation implants that stabilize adjacent vertebral bodies without damaging the superior facet. The interbody and disc implants can be installed using intelligent devices capable of repeatedly providing precise placement of the implants. The procedure can be performed with or without navigation and / or robot assistance. Robot-enabled procedures can utilize imaging, navigation, and robotics to enhance the quality and efficiency of posterior procedures through planning and navigable devices.

[0051] Further aspects, advantages, and / or other features of exemplary embodiments of the present invention will become apparent from the following detailed description. It will be apparent to those skilled in the art that the embodiments described herein are merely exemplary and illustrative, and not restrictive. Various embodiments and modifications thereof falling within the scope of this disclosure and its equivalents are contemplated.

[0052] Now for reference Figures 1A to 1C This diagram illustrates an intervertebral lumbar interbody fusion system or orthopedic fixation system 10 for fusing two adjacent vertebrae 2. The fixation system 10 may include an expandable intervertebral body implant 12 and one or more pedicle-based fixation implants 14. The expandable intervertebral body implant 12 is positioned in the intervertebral disc space 4 between the superior vertebral body 6 and the inferior vertebral body 6. The intervertebral body implant 12 may be positioned along the annulus ossicularis for cortical bone support. The expandable intervertebral body implant 12 may include dual independent expansion and angulation to adjust lordosis and / or coronal balance, thereby allowing restoration of spinal anatomical alignment. The pedicle fixation implant 14 may include an intradiscal device configured to be deployed from the inferior pedicle 8, through the inferior vertebral body 6, through the intradiscal space 4, and into the superior vertebral body 6. The first and second pedicle fixation implants 14 may pass through the pedicle 8 of the inferior vertebra 2 and be centrally positioned relative to the intervertebral body implant 12. The fixation system 10 provides excellent segmental correction from the stabilizing device 12 and independently controlled sagittal and coronal correction and increased stability from increased endplate contact along the bony ring, as well as a fixation structure that avoids damage to the superior facet joints and the potential iatrogenic effects of conventional bilateral pedicle structures.

[0053] Turn now Figures 2A to 2DThe expandable intervertebral body implant 12 may include three segments or legs 20, 22, 24 configured to hinge or pivot relative to each other at pin 26 to increase the overall width or area occupied by the implant 12. The implant 12 may include a first expandable lateral leg 20, a second expandable lateral leg 22, and a third anterior or central leg 24 having a link plate 28 connecting the first lateral leg 20 and the second lateral leg 22. Each of the lateral legs 20, 22 may include an actuation assembly 30, such as a drive screw or actuator configured to move a plurality of drive ramps that extend the height of the endplates of the lateral legs 20, 22. When the first lateral outrigger 20 and / or the second lateral outrigger 22 extend independently in height, the attached link plate 28 is configured to passively increase in height, thereby providing forward convexity and / or crown adjustment.

[0054] Turn now Figure 3 and Figures 4A to 4B The pedicle-based fixation implant 14 may consist of two biocompatible components: a rod 40 and a screw 42. The rod 40 may be made of nitinol or other shape memory materials, allowing the rod 40 to bend into a curved state upon deployment. The nitinol rod 40 may include a proximal end 44 configured to engage with the pedicle screw 42 and a distal end 46 configured to engage with bone. The hyperelasticity of nitinol allows the material to be stretched from its naturally curved state into a straight configuration. In its relaxed state, the nitinol rod 40 may have a curve or arc of 180° or more. The body of the nitinol rod 40 may have a polygonal cross-section with a planar surface. For example, the body may have a quadrilateral cross-sectional shape, such as a square. The distal end 46 may include a pointed or sharp tip configured to pierce bone. The proximal end 44 may include a threaded portion 48 that engages with the screw 42. The nickel-titanium rod 40 can be deployed through the pedicle 8 of the lower vertebra 2, and the distal end 46 can pass through the vertebral body 6 of the lower vertebra 2, through the intervertebral disc space 4 and into the vertebral body 6 of the upper vertebra 2.

[0055] Screw 42 may include a pedicle screw extending from a proximal end having a screw head 50 to a distal end having a tip 52 configured to engage a nitinol rod 40. Screw 42 may be made of titanium or any suitable biocompatible material. Screw head 52 may define a drive recess that can be engaged by a screw-driven instrument or other means. Screw head 50 may have any general shape. In the illustrated embodiment, screw head 50 has a threaded or roughened curved or spherical surface. Screw head 50 may interface with a multi-axis tulip-shaped head that retains a spinal rod. Examples of tulip-shaped head and rod constructions are described in more detail, for example, in U.S. Patent 10,368,917, which is incorporated herein by reference in its entirety for all purposes. Screw 42 has a threaded shaft 54 ​​configured to engage bone. It should be understood that the threaded shaft 54 ​​may have many different characteristics, such as lead, pitch, thread angle, shaft diameter to thread diameter, overall shaft shape, etc. It is also conceivable that the threaded shaft 54 ​​could be replaced by another suitable bone fastener, such as an anchor, clamp, etc., configured to engage the bone.

[0056] The threaded shaft 54 ​​of the pedicle screw 42 may define a hollow body for receiving the proximal end 44 of the nitinol rod 40. The hollow body may extend along a portion or the entire length of the screw 42. The hollow body defines an internal threaded portion configured to mate with an external threaded portion 48 of the nitinol rod 40. It should be understood that one or more additional features may be used to lock the screw 42 to the nitinol rod 40, such as a snap ring within the pedicle screw 42 configured to snap into an external groove 56 of the nitinol rod 40. The pedicle screw 42 may be deployed with the nitinol rod 40 through the same pedicle 8 of the lower vertebra 2. The pedicle screw 42 is inserted and driven over the proximal threads 48 of the nitinol rod 40 to grip the existing cortical bone in the pedicle 8 and anchor the proximal end 44 of the nitinol rod 40 to the lower pedicle 8.

[0057] Turn now Figure 5The intervertebral lumbar interbody fusion procedure may have a structured workflow 60 for preparing and installing an expandable interbody implant 12 and a pedicle-based fixation implant 14. The workflow 60 may include one or more of the following steps: (1) Preoperative imaging 62 may be performed on the patient's anatomy, such as CT (computed tomography), MRI (magnetic resonance imaging), or other relevant imaging. (2) Preoperative planning 64 may provide planned placement of the expandable interbody 12, planned access path, planned placement of the nitinol rod fixation device 14, and review of the planning strategy. (3) Access to and decompression 66 of the intervertebral disc space 4 may be planned. Access to the intervertebral disc space 4 may be performed via MIS (minimally invasive surgery) or open surgery. This access may be made using navigation devices and / or robot assistance. (5) A double-door discectomy 68 may be performed to improve the efficiency and overall quality of soft tissue removal. (6) Interbody deployment 70 may include deployment, positioning, articulation, and expansion of the implant 12. (7) Nitinol fixation deployment 72 may include deploying the pedicle-based intervertebral disc fixation implant 14 through the pedicle 8 of the lower vertebra 2 and into the vertebral body 6 of the upper vertebra 2. (8) Final verification 74 may include checking the position of the intervertebral body and the pedicle-based fixation implants 12, 14, and ensuring that the final construction completes the preoperative plan and achieves the desired correction. Imaging, navigation, and / or robotics may be used to assist and enhance the workflow 60.

[0058] Figures 6A to 6B An example of a surgical robot and navigation system 80 is shown. The surgical robot system 80 may include, for example, a surgical robot 82, a base 86 including a computer, a display or monitor 88 electrically coupled to the computer (and optionally a wireless tablet), one or more computer-controlled robotic arms 84, and an end effector 90 including a guide tube 92 electrically coupled to the robotic arms 84. The surgical robot system 80 may also utilize a camera 94, for example, positioned on a separate camera mount 96. The camera mount 96 may have any suitable configuration to move, orient, and support the camera 94 at a desired location. The camera 94 may include any suitable camera or multiple cameras, such as one or more infrared cameras (e.g., dual-focal or stereophotogrammetry cameras), capable of identifying active and / or passive tracking markers in a given measurement volume, for example, visible from the viewpoint of the camera 94. The camera 94 may scan the given measurement volume and detect light from the markers to identify and determine the markers' positions in three dimensions. For example, active markers may include infrared emitting markers activated by electrical signals (e.g., infrared light-emitting diodes (LEDs)), and passive markers may include retroreflective markers that reflect infrared light emitted, for example, by an illuminator on camera 94 or another suitable device (e.g., they reflect incident IR radiation into the direction of the incident light).

[0059] The surgical robot 82 is capable of controlling the translation and orientation of the end effector 90. For example, the robot 82 may be able to move the end effector 90 along the x-axis, y-axis, and z-axis. The end effector 90 may be configured to selectively rotate about one or more of the x-axis, y-axis, and z-axis, as well as the Z-frame axis (such that one or more of the Euler angles associated with the end effector 90 (e.g., roll, pitch, and / or yaw) can be selectively controlled). In some exemplary embodiments, selective control of the translation and orientation of the end effector 90 can allow medical procedures to be performed with significantly improved accuracy.

[0060] Robotic positioning system 82 includes one or more computer-controlled robotic arms 84 to assist a surgeon in planning the position of one or more navigation instruments relative to intraoperative patient images. System 80 includes 2D and 3D imaging software that allows for preoperative planning, navigation, and guidance via dynamic reference datum, navigation instruments, and positioning camera 94 for the placement of spinal, orthotics, or other devices. Further examples of surgical robots and / or navigation systems can be found, for example, in U.S. Patent 10,675,094 and U.S. Patent 9,782,229, which are incorporated herein by reference in their entirety for all purposes.

[0061] Turn now Figure 7 and Figures 8A to 8C This diagram illustrates a dual-door posterior access system and technique that can be robotically enabled to assist surgeons during surgery. A dual-door assembly 100 is configured to attach to a guide tube 92 of an end effector 90 of a robot 82. In this manner, the robot 82 is configured to control the position and orientation of the dual-door assembly 100 relative to the surgical area. The dual-door assembly 100 includes a guide rod assembly 102, a first navigation cannula assembly 104, and a second navigation cannula assembly 106. The entire dual-door assembly 100 is configured to pivot or rotate about a central longitudinal axis A of the guide tube 92 of the end effector 90. The first navigation cannula assembly 104 and the second navigation cannula assembly 106 are each configured to be independently angled relative to the central longitudinal axis A, thereby providing a desired access trajectory to the surgical area. The dual-door assembly 100 may include a plurality of tracking markers 108 configured to monitor various features of the dual-door assembly 100 and provide navigation and / or robotic assistance during surgery.

[0062] like Figure 8ABest viewed from above, the guide rod assembly 102 includes a central guide rod 110 configured to insert into the bottom of the guide tube 92 of the end effector 90. The guide rod assembly 102 includes a central support arm 112 for retaining a first lateral wing 114 and a second lateral wing 116. The first lateral wing 114 and the second lateral wing 116 are positioned on opposite sides of the guide rod 110 and extend outward in opposite directions to each other. The first lateral wing 114 supports a first navigation sleeve 120 via a first support arm 124, and the second lateral wing 116 supports a second navigation sleeve 122 via a second support arm 126. Each navigation sleeve 120, 122 includes a long, hollow tubular body defining a central longitudinal axis A1, A2, respectively. Each navigation sleeve 120, 122 is configured to guide an instrument placed through the respective sleeve 120, 122 along a desired trajectory to the surgical site.

[0063] Further details Figure 8A The guide rod 110 is configured to slide into and axially lock into the guide tube 92 of the end effector 90. For example, the guide rod 110 may snap into an axial locking cover 130. The axial locking cover 130 may snap onto an inner portion of the end effector 90 to avoid obstructing infrared LEDs 132, which act as tracking markers for the end effector 90. The upper portion of the locking cover 130 may rest on the top surface of the end effector 90 above the guide tube 92. The locking cover 130 may include a locking button 134 configured to engage a recess 136 of the guide rod 110. The recess 136 may be positioned between two annular rings at the proximal end of the guide rod 110. The locking button 134 may be spring-loaded to automatically engage the recess 136 as the guide rod 110 slides upward through the inner diameter of the guide tube 92 of the end effector 90. When locked with locking cover 130, guide rod assembly 102 is axially constrained to guide tube 92, but is still allowed to rotate about longitudinal axis A of guide tube 92. Alternatively, locking connection to end effector 90 of robot 82 may be constructed into guide rod 110, rather than through end effector 90. It should be understood that other suitable locking mechanisms may also be used.

[0064] After the guide rod assembly 120 is axially locked to the end effector 90, the guide rod assembly 120 can be rotated to the desired position. For example... Figure 8BAs shown, the first lateral wing 114 and the second lateral wing 116 are rotatable about the longitudinal axis A of the guide tube 92. Once the desired rotational position is achieved, the rotational movement of assembly 102 can be secured using a center wheel handle lock 140. The center wheel handle lock 140 may have a threaded bolt 148 that is mounted into a threaded hole in the guide rod assembly 120. Rotation of the center wheel handle lock 140 tightens, retains, and locks the guide rod assembly 120 in its final position. It should be understood that another suitable lock can also be used to secure the guide rod assembly 120.

[0065] Key Introduction Figures 9A to 9B After the rotational position has been locked, the width and / or angle of the first navigation sleeve 120 and the second navigation sleeve 122 can be adjusted independently. The first lateral wing 114 and the second lateral wing 116 may be curved or angled to allow for angle adjustment of the sleeves 120, 122 as they move along the lateral wings 114, 116. For example, the first lateral wing 114 and the second lateral wing 116 may be curved or angled such that the ends of the wings 114, 116 point downwards, thereby providing a greater degree of angle as the sleeves 120, 122 move further from the central guide rod 110.

[0066] Each of the first lateral wing 114 and the second lateral wing 116 may include an elongated slot 142 for securing a corresponding first navigation sleeve assembly 104 and a corresponding navigation sleeve assembly 106. Navigation sleeve assemblies 104, 106 may slide along the corresponding slot 142 to adjust the width and / or angle of the sleeves 120, 122. Figure 8B Ideally, the top surfaces of the wings 114, 116 may each include graduations, indicator scales, or other markings 144 to provide visual feedback on the distance and / or angle of the sleeves 120, 122. For example, each graduation scale 144 of each sleeve 120, 122 may be in the range of 10°–24°, with increments of 2°. Openings 150 in the top surfaces of the support arms 124, 126 of the sleeve assemblies 104, 106 provide accurate readings of the graduation marks on the indicator scales 144.

[0067] Cannula assemblies 104, 106 are movable along one or more ratchet 146. The ratchet 146 may include linear or curved ratchet 146 configured to mimic the shape of the lateral wings 114, 116. The ratchet 146 may be positioned above and below the elongated slot 142. The ratchet 146 may include a rack and pinion system for independently moving the cannula assemblies 104, 106 along the lateral wings 114, 116. The ratchet 146 can provide incremental adjustment of the width and / or angle of the cannulas 120, 122. For example, the angle of the first cannula 120 may be aligned to match a desired position of a first lateral leg 20 of the implant 12, and the angle of the second cannula 122 may be aligned to match a desired position of a second lateral leg 22 of the implant 12. Additionally, the width between the first cannula 120 and the second cannula 122 may match a desired width between the lateral legs 20, 22 of the implant 12. The width and / or angle of sleeves 120 and 122 can be locked independently with each of the rotatable knobs 152. Rotation of each knob in 152 tightens, retains, and locks the final position of each of sleeves 120 and 122. It should be understood that any suitable lock can be used to secure sleeves 120 and 122.

[0068] The dual-door assembly 100 may include multiple tracking marks 108, such as passive spherical marks, configured to monitor the positions of the guide rod assembly 102 and the first navigation sleeve assembly 104 and the second navigation sleeve assembly 106, respectively. In the illustrated embodiment, nine marks 108 are used to track the positioning and location of the components; however, it should be understood that any suitable number and configuration of marks may be selected. The distal end of the guide rod 110 may include a first tracking mark 108. The end of the first lateral wing 114 may include a second tracking mark 108, and the end of the second lateral wing 116 may include a third tracking mark 108. The bottom of the first support arm 124 may include a fourth tracking mark 108, and the bottom of the second support arm 126 may include a fifth tracking mark 108. The first navigation sleeve 120 may include a sixth and a seventh tracking mark 108 aligned along the central longitudinal axis A1 of the sleeve 120. The second navigation sleeve 122 may include an eighth and a ninth tracking mark 108 aligned along the central longitudinal axis A2 of the sleeve 122. In this way, the tracking marker 108 is configured to provide the robot system 80 with information about the sleeves 120, 122 and the double-door assembly 100, such as position, orientation, distance, angle and other relevant information.

[0069] Turn now Figure 10 , Figures 11A to 11B and Figures 12A to 12BEach cannula assembly 104, 106 may include adjustable stops 160, 162 configured to set an entry depth into a surgical site. Depth control may be set independently for each trajectory in a customized entry trajectory, for example, for abnormal patient anatomy. Each stop 160, 162 may include a sleeve or tubular body configured to slide over or along the respective cannula 120, 122. Stops 160, 162 may slide along an elongated slit 164 extending along the central longitudinal axes A1, A2 of the cannulas 120, 122. Pins or other engaging members from stops 160, 162 may be received in the slit 164 to guide stops 160, 162 to the desired depth. The depth may be locked using a lever latch 166. Lever latch 166 may include a pair of pivotable thumb latches positioned on opposite sides of the cannulas 120, 122. When pressed and squeezed together, lever latch 166 allows depth stops 160, 162 to slide along the length of sleeves 120, 122. When released, lever latch 166 locks the depth stops 160, 162 in position, thereby providing maximum access depth for any instrument placed through sleeves 120, 122. Figure 10 The illustrated implementation provides deeper access to the intervertebral disc space 4 via a right trajectory along axis A1 compared to a left trajectory along axis A2. It should be understood that stops 160 and 162 can be independently adjusted to provide the same or different access depths. Alternatively, instead of manual control, robot 82 can control and automatically generate width, angle, and / or adjustable depth control settings for cannulas 120 and 122.

[0070] Key Introduction Figures 11A to 11B The navigation device 170 can be positioned through each cannula 120, 122 to access the surgical site. The navigation device 170 can extend from a proximal end 172 to a distal end 174, the proximal end having a handle configured for user gripping, and the distal end having a tip configured for access to the surgical site. The navigation device 170 may include an array 176 with multiple tracking markers 178, such as spherical passive markers, configured to be identified and monitored by the navigation and robotic system 80 to monitor the movement of the device 170. The navigation device 170 is compatible with expanders, eccentric sheaths, docking facet expanders, and other instruments. Figures 12A to 12B Instruments 180, positioned through cannulas 120 and 122, are shown. Stops 160 and 162 are adjustable using the existing instruments 180. By removing the navigation array 176, instruments 180 can provide improved visualization of the surgical site.

[0071] Key Introduction Figures 13A to 13CThe diagram illustrates direct visualization port assemblies 190 and 192 according to one embodiment. Direct visualization port assemblies 190 and 192 can replace cannula assemblies 104 and 106 to increase visualization of neurons during decompression. A first lateral wing 114 of guide rod assembly 102 supports the first port assembly 190, and a second lateral wing 116 of guide rod assembly 102 supports the second port assembly 192. Each of the port assemblies 190 and 192 may include an access port 194, a movable attachment assembly 196, and an extension arm 198 connecting the access port 194 to the attachment assembly 196. In the same manner as cannula assemblies 104 and 106, the attachment assembly 196 can slide along a corresponding slot 142 through the first lateral wing 114 and the second lateral wing 116 to adjust the width and / or angle between the port assemblies 190 and 192. Figure 13A As shown, each attachment component 196 and access port 194 can be aligned along the central longitudinal axis B1, B2.

[0072] Access port 194 may include a hollow tubular body for accessing a surgical site. Port 194 may be attached to the distal end of extension arm 198 via collar 202, which provides a pivotable joint at the proximal end of access port 194. Collar 202 may have a tapered, spherical, or other suitable interface with port 194 to allow independent angulation of port 194. Figure 13B As shown, the right port 194 can be angled laterally outward and offset from the longitudinal axis B1. Figure 13C In the middle, the right port 194 can be angled inward toward the midline, but still off-axis with respect to the longitudinal axis B1. It should be understood that both the left and right ports 194 have independent angles based on the desired entry into the surgical site. The depth of the ports 194 can also be controlled via the extension arm 198. The extension arm 198 can translate the ports 194 toward or away from the surgical site, thereby providing customized adjustability for each of the ports 194. Therefore, the width and angle between the ports 194, the cone angle of the ports 194, and the depth of the ports 194 can be adjusted to increase visualization and improve the safety of neurons surrounding the spine.

[0073] Figures 14A to 14DA navigable instrument assembly 210 according to one embodiment is depicted. The navigable instrument assembly 210 may include an instrument 212 and an adjustable stop 160. Although stop 160 is described, it should be understood that stop 162 is identical, or another suitable stop may be substituted. Instrument 212 may include a body extending from a proximal end 214 configured to attach to an electric handle to a distal end 216 having an instrument tip. Instrument tip 216 may include a bone drill, drill bit, bone chisel, reamer, or other suitable instrument for cutting and / or removing bone. Instrument 212 may be powered to provide high-speed, oscillating, or other suitable electric tip 216. A shaft 218 of instrument 212 may support an array 220 having a plurality of tracking markers 222, such as spherical passive markers, configured to identify and monitor the movement of instrument 212 by a navigation and robotic system 80. The shaft 218 of instrument 212 can be received by a retaining sleeve 222, which attaches the adjustable stop 160 to instrument 212. The retaining sleeve 222 is positioned through the tubular body of the adjustable stop 160. The retaining sleeve 222 includes an enlarged neck 226 located at its proximal end, configured to abut the proximal end of the stop 160 when received. The retaining sleeve 22 includes one or more rib-like portions 228 configured to interface with a pivotable thumb latch of lever latch 166, thereby securing the position of the stop 160. Instrument assembly 210 can be navigated independently or via a cannula such as navigation cannulas 120, 122 to perform surgical procedures.

[0074] Turn now Figures 15A to 15C and Figures 16A to 16B An adjustable implant cannula 230 according to one embodiment is shown. The adjustable implant cannula 230 includes a hollow cannula body 232 and an adjustable threaded cap 234. The cannula body 232 extends from a proximal end 236 to a distal end 238. The proximal portion 236 may be externally threaded to engage with the internally threaded cap 234. The overall length of the implant cannula 230 is adjusted as the cap 234 is rotated. An indicator 240 is used to set the adjustable implant cannula 230 to a planned depth. The indicator 240 may include a window through the threaded cap 234 and markings that can be aligned with graduations such as those in increments of 2 between 0 and 12. After the depth has been set, a cannula dilator 242 may be loaded into the implant cannula 230, such as... Figure 15C As shown. The cannula dilator 242 may include a cap 244 located at its proximal end and a distal tip 246 configured to expand. The distal tip 246 of the cannula dilator 242 may be keyed into a corresponding recess 248 located at the distal end 238 of the cannula body 232.

[0075] like Figure 16AAs shown, the adjustable implant cannula 230 can pass through the navigation cannulas 120 and 122 for positioning. Figure 16B In this configuration, each cannula expander 242 is positioned through the implant cannula 230. For assembly, the cap 244 of the expander 242 is struck until it impacts the surfaces of the navigation cannulas 120, 122, and the implant cannula 230 is simultaneously locked into the navigation cannulas 120, 122 at the planned depth. The expander 242 can then be expanded to create or enlarge space in the bone. After the expander 242 is removed, the implant cannula 230 can be used for discectomy.

[0076] Turn now Figures 17A to 17B A navigable discectomy instrument 250 according to one embodiment is shown. The navigable discectomy instrument 250 includes an elongated fixation body 252, an elongated slidable body 254 adjacent to the fixation body 252, a fixation handle 256 connected to the fixation body 252, a hinged clamping member 258 pinned to the fixation handle 256, and a hinged distal tip 260 configured to cut bone. When the hinged clamping member 258 is pressed toward the fixation handle 256, the slidable body 254 translates longitudinally along the fixation body 252, thereby pivoting the hinged tip 260 about a pivot pin. Figure 17A The hinged tip 260 is shown in the open, extended position, and Figure 17B A hinged clamp 258 is shown that presses inward to pivot the tip 260, thereby folding the tip 260 toward the fixing body 252 to cut and remove soft tissue.

[0077] The navigable discectomy instrument 250 may include one or more tracking markers 264, 268 for positioning and orientation of the instrument 250 and for articulating the discectomy tip 260. A fixed body 252 may support a tracking array 262 having multiple tracking markers 264, such as spherical passive markers, identified and monitored by a navigation and robotic system 80. Additionally, a pivotable arm 266 may support a single marker 268 that moves when the articulated gripper 258 is compressed. Thus, a single marker 268 is movable relative to the array 262 of fixed markers 264. Figure 17A As shown, a single mark 268 has a first position pointing proximally when the hinged tip 260 extends distally. When the clamp 258 is pressed and the tip 260 is pivoted, the single mark 268 pivots to a second position pointing distally, as shown. Figure 17B As shown. In this way, the navigation and robotic system 80 is able to track the placement and articulation of the distal tip 260 to confirm soft tissue removal and endplate preparation. This can be used to enhance discectomy by helping to confirm placement and orientation.

[0078] like Figures 18A to 18CAs shown, discectomy can be performed using the discectomy instrument 250. After the implant cannula 230 is inserted and axially locked in the navigation cannulas 120, 122, discectomy can be performed through the implant cannula 230 to improve the efficiency and overall quality of soft tissue removal. Figures 18A to 18C In this procedure, a pair of discectomy instruments 250 are inserted through the implant cannula 230 and into the intervertebral disc space 4, and the hinged tip 260 is pivoted to remove soft tissue. Dual discectomy allows for easier intervertebral body insertion and positioning, and increases the volume of bone grafts within the intervertebral disc space to promote faster fusion. The discectomy instruments 250 can utilize navigation to track placement and hinge at the distal tip 260 to confirm soft tissue removal and endplate preparation within the automatically generated volume space of the intervertebral disc.

[0079] Key Introduction Figures 19A to 19B and Figures 20A to 20C An electrically powered discectomy device 270 according to another embodiment is shown. The discectomy device 270 may be powered, for example, by a motor, to provide enhanced removal of disc material between the endplates of adjacent vertebrae. The electrically powered discectomy device 270 may include an articulated soft tissue cutter, curette, or cutting tip 272 that can be configured to simultaneously release both the nucleus pulposus and annulus fibrosus from the inferior and superior endplates of vertebra 2. Figures 19A to 19B As shown, a discectomy instrument 270, including a cutting tip 272, is configured to pass through an implant cannula 230 to enter the intervertebral disc space 4. The cutting tip 272 may be hinged to reach around the intervertebral disc space 4. Although only one implant cannula 230 and instrument 270 are shown, it should be understood that for bimanual discectomy, the instrument 270 may be used alone on the contralateral side or may be used simultaneously on the contralateral side with the ipsilateral side.

[0080] like Figures 20A to 20C As shown, the cutting tip 272 may include a superior endplate 274 and a inferior endplate 276, which have multiple teeth configured to cut and release intervertebral disc material. The cutting tip 272 of the discectomy instrument 270 may be configured for passive expansion. The superior endplate 274 and the inferior endplate 276 may be able to expand away from each other. As the intervertebral disc material is cut, released, and emptied, a space is created between the inferior and superior endplates of the vertebra 2. One or more spring-loaded incisions 278 in the cutter 272 may allow passive expansion. Figure 20C As shown in the best embodiment, the spring cut 278 can be bifurcated by a central slit 280, which provides a built-in gap for the cutter 272 in its collapsed state.

[0081] Turn now Figures 21A to 21FThis paper illustrates a method for inserting and positioning an expandable intervertebral body implant 12 according to one embodiment. The intervertebral body implant 12 can be positioned in the intervertebral disc space 4 using a first insert 300 by inserting the intervertebral body 12 through an implant cannula 230, using a cable 296 to pull the lateral legs 20 of the implant 12 to the opposite implant cannula 230, and connecting a second insert 302 through the opposite implant cannula 230. A cable assembly 292 threaded to one of the legs 20 of the implant 12 can use a magnet 294 to pull the intervertebral body 12 into its natural U-shaped position, wherein the proximal ends of the lateral legs 20, 22 are connected to the inserts 300, 302 through the respective implant cannulas 230.

[0082] Key Introduction Figure 21A A hinged magnetic retrieval and deployment tool 290 can be deployed through the contralateral implant cannula 230. The hinged magnetic tool 290 can be hinged to guide the tool 290 toward the ipsilateral implant cannula 230. The hinged magnetic tool 290 can magnetically attract and connect to a magnetic tip 294 of a cable assembly 292 positioned through the ipsilateral implant cannula 230. The cable assembly 292 includes a magnetic tip 294 attached to a traction cable 296. The traction cable 296 may include a cable, wire, rope, chain, or other suitable line configured to traction between implant cannulas 230. The traction cable 296 may have a coiled end at the magnetic tip 294. Opposite ends of the traction cable 296 may be coupled to the ends of the lateral legs 20 of the implant 12. For example, the traction cable 296 may be secured to the implant 12 using a proximal threaded cap 298.

[0083] like Figure 21B As shown, the articulated magnetic tool 290 retracts through the contralateral implant cannula 230, thereby pulling the magnetic tip 294 and the attached cable 296 into the contralateral implant cannula 230. After the articulated magnetic retrieval tool 290 has connected through the contralateral implant cannula 230 and pulled the coiled end of the cable assembly 292, the cable 296 can be placed under tension because the ipsilateral insert device 300 is rigidly connected to the second lateral leg 22 of the implant 12.

[0084] exist Figure 21C In this configuration, implant 12 is fed through insert 300 and ipsilateral implant cannula 230, wherein cable assembly 292 remains attached to the opposite end of implant 20. Implant 12 is hinged at pin 26. Figure 21DAs shown, cable 296 helps pull intervertebral body 12 into its articulated U-shaped position, where lateral legs 20, 22 bend at pin 26 to increase the overall width or area occupied by implant 12. Threaded cap 298 aligns with the outlet of the contralateral implant cannula 230. It is desirable to check the rigidity of the insert connection before unscrewing the proximal threaded cap 298 from intervertebral body 12 to release the cable assembly from intervertebral body 12.

[0085] Figure 21E Views of inserts 300 and 302 are shown, with the cannula 230 omitted for clarity. Inserts 300 and 302 may each include an outer sleeve 304 through which a shaft 306 extends. The end of the shaft 306 may provide threaded engagement with the ends of the lateral legs 20 and 22 of the implant 12. Figure 21E In the middle, the threaded sleeve 304 and the anti-torque shaft 306 of the second insert instrument 302 are positioned through the contralateral implant cannula 230. Figure 21F In the final configuration shown, the second insert 302 is threaded onto the opposite leg 20 of the implant 20, while the first insert 300 remains rigidly connected to the same-side leg 22 of the implant 20. This dual connection provides dual intervertebral body control of the implant 12. Therefore, the overall position of the implant 12 and each of the lateral legs 20, 22 can be manipulated or moved by both inserts 300, 302.

[0086] Figure 22 A complete overview of the dual-gate assembly 100 with both navigable inserts 300 and 302 is shown. The guide rod assembly 102 secures the first navigation cannula assembly 104 and the second navigation cannula assembly 106 along a desired trajectory. An implant cannula 230 is positioned through the respective navigation cannula assemblies 104 and 106. Inserts 300 and 302 are positioned through the respective implant cannulas 230. Once both inserts 300 and 302 are attached to the lateral support legs 20 and 22 of the implant 12, the navigable array 308 can be attached to the inserts 300 and 302 for precise placement of the intervertebral body 12, thereby providing excellent segmental correction and stability.

[0087] Turn now Figures 23A to 23BOnce the collapsed intervertebral body implant 12 is accurately placed and positioned, the actuator 310 can be placed through inserts 300, 302 to expand the implant 12. After removing the handles of inserts 300, 302 and the array 308, the actuator 310 can be placed on both the ipsilateral insert 300 and the contralateral insert 302 and axially clamped to the respective inserts 300, 302. The distal tip of each actuator 310 can interface with the actuating member 30 of the implant 12 to allow independent expansion of the lateral legs 20, 22 of the implant 12. The handle of the actuator 310 can be rotated to rotate the actuating member 30, thereby expanding the respective legs 20, 22 of the implant 12. Arrays and / or smart devices can be used to ensure parallel, anteflex, coronal, or other desired expansion of the implant 12.

[0088] Turn now Figures 24A to 24C and Figures 25A to 25F After the intervertebral body 12 is implanted, an intervertebral disc fixation implant 14 based on the pedicle can be installed. Figures 24A to 24C A rod fixation device 320 according to one embodiment is shown. The rod fixation device 320 is configured to load and deploy a rod 40 of a pedicle-based intervertebral disc fixation implant 14. The rod fixation device 320 may include a body 322, with a deployment tube 324 located at the distal end of the body. The deployment tube 324 is straight and configured to introduce a bent rod 40, thereby straightening the rod when it is held within the deployment tube 324. The device 320 loads the nitinol rod 40 into the straight deployment tube 324 by introducing the rod 40 from a threaded proximal end 48. The deployment tube 324 can be customized for a specific product size because the bend diameter or head-to-tail height of the nitinol rod 40 can have a proportional rod thickness to improve hyperelastic properties proportional to its strength.

[0089] The rod retainer 320 may include a T-shaped handle 326 having a socket 328 configured to receive on a shaft 330 having a clamping cap 336. The socket 328 snaps into engagement with a button 332. As the handle 326 rotates about the longitudinal axis of the device 320, the nitinol rod 40 is drawn into the deployment tube 324. The handle 326 can be released by actuating the engagement of the button 332. Figure 24C As shown, after the guide rod assembly 102 has been removed from the guide tube 92 of the end effector 90, the Nitinol deployment device 320 is then positioned through the guide tube 92 of the end effector 90. The device 320 can be locked into the axial locking cover 130 via an external circumferential groove 334 in the body 322 of the device 320.

[0090] like Figures 25A to 25BAs shown, the rod fixation device 320 is positioned for deploying the rod 40. After accessing the posterior portion of the spine, the end effector 90 is positioned in place. A hole can be pre-drilled into the pedicle 8 of the lower vertebra 2. The nitinol rod 40 can be positioned in the prepared hole, locked into the end effector 90, and ready to be clamped for deployment.

[0091] exist Figures 25C to 25D In this process, the Nitinol rod 40 is deployed through the lower vertebral body 6, through the intervertebral disc space 4, and into the upper vertebral body 6. The axis 330 of the deployment device 320 can be translated distally along the longitudinal axis of the device 320, for example, by striking the clamping cap 336 with a surgical hammer. The axis 330 forces the Nitinol rod 40 outward from the deployment tube 324. The hyperelastic properties of Nitinol allow the Nitinol rod 40 to return to its natural curvature throughout the deployment process, thereby sweeping across the lower pedicle 8, through the intervertebral disc space 4, centered laterally towards the intervertebral body legs 20, 22, and into the upper vertebral body 6. After the clamping cap 336 is lowered to its lowest point, the rod 40 is fully deployed, and the deployment device 320 can be removed.

[0092] exist Figures 25E to 25F In this procedure, the pedicle screw 42 is fixed and anchored to the nitinol rod 40. The pedicle screw is inserted into the lower pedicle 8 via the actuator 340 positioned through the guide tube 92. The pedicle screw 42 is inserted and driven over the proximal thread 48 of the nitinol rod 40 to grip the existing cortical bone in the pedicle 8 and anchor the proximal end 44 of the nitinol rod 40 to the lower pedicle 8. This process can then be repeated for the contralateral second intervertebral disc fixation implant 14. Figures 25A to 25F The process is shown.

[0093] Figures 26A to 26D An example of a complete construction 10 including an intervertebral body implant 12 and two intervertebral disc implants 14 is shown. Figure 26A A rear view is provided of the spine located in the pedicle 8 of the lower vertebra 2 and the two intervertebral disc implants 14. Figure 26B A side view of the spine is shown, in which the intervertebral body implant 12 is positioned in the intervertebral disc space 4 between the vertebrae 2. Figure 26C A front view of the spinal and intervertebral body implant 12 is shown. Figure 26D This is an internal view of the intervertebral disc of the system 10, which includes an intervertebral body implant 12 and two intradiscal implants 14. The complete configuration 10 provides excellent stability according to the posterior approach. The intradiscal implants 14 do not damage the superior facet joints, thereby limiting adjacent segmental disease that could result from damage to the superior adjacent facet joints.

[0094] According to one implementation, the procedure may be performed using navigation and / or robot assistance. Robot-enabled procedures may include workflows enhanced with the use of imaging, navigation, and robot assistance, including: (1) preoperative planning; (2) end effector setup; (3) tubular access and decompression or alternative visualization port workflows; (4) double-door implant cannula insertion; (5) double-door discectomy; (6) intervertebral body deployment, positioning, and extension; (7) nitinol fixation construction; and (8) final validation. Robot-enabled procedures may utilize imaging, navigation, and robotics to enhance the quality and efficiency of posterior procedures through planning and navigable instruments.

[0095] The first step in the workflow may include preoperative planning. The importance of a structured workflow for robot-enabled dual-gate interbody fusion techniques is highlighted in the preoperative imaging and planning phases. A step-by-step user interface can be provided on the monitor 88 of the robot 80 to guide healthcare professionals through precise interbody placement, depth-controlled access to decompression devices, and fixation plan deployment. Control over these aspects can be enhanced with sagittal, axial, coronal, and 3D volumetric views of the patient's anatomy, with the addition of a combined CT-MRI display for identifying and visualizing neurons, for a safe and repeatable procedure.

[0096] The planning phase can follow a detailed checklist. After selecting the level to be corrected on monitor 88, a virtual representation of the anterior or central leg 24 of the three-legged intervertebral body implant 12 can be placed along the anterior side of the annulus fibrosus on the midline. The intervertebral body 12 has dual independent extensions and angulations on the lateral legs 20, 22. The intervertebral body 12 can be accessed into the intervertebral disc space 4 using a double-gate system based on the width of the anterior leg 24 and the angulations and lengths of the lateral legs 20, 22. The angulations of the lateral legs 20, 22 can be controlled in the transverse plane at the planning level, thus shifting from central to lateral. The parallel and lordotic extensions of the lateral legs 20, 22 can be planned independently or mirror-image of each other before the procedure. All size settings, positioning, and extensions of the intervertebral body's occupies the area to help tailor the correction to the patient's anatomy.

[0097] Once the planned anterior width and outrigger angulation are set, the surgeon can plan the removal of posterior bony structures to access the intervertebral disc space 4. For example, pre-planned depth stops can be used to enter the instrument along a given trajectory. In one embodiment, stops 160, 162 can be provided to protect neuroanatomical structures from the influence of the powered instrument. The planned implant cannula depth can be set independently relative to the proximal ends of the left outrigger 20 and right outrigger 22 of the intervertebral body 12.

[0098] The final stage of the preoperative planning checklist involves planning the trajectory, rod size setting, and pedicle screw size setting for the nitinol fixation implant 14. The nitinol fixation implant 14 is positioned centered relative to the lateral supports 20, 22 and posteriorly to the anterior support 24 of the intervertebral body 12. The size of the implant is determined based on which curvature fits within the inferior and superior vertebral bodies 6, without damaging the facet or the axis of the pedicle 8 of the superior vertebra 2. The size of the pedicle screw 42 is set to ensure that the screw 42 captures the proximal end 44 of the nitinol rod 40 when the screw head 50 protrudes from the pedicle 8.

[0099] The second step in the workflow may include manual setup of the end effector. Once the preoperative planning overview is complete, the guide rod assembly 102 can be introduced into the end effector 90 to introduce single-position dual-door control. An axial locking cap 130 can snap onto the inner portion of the end effector 90 to avoid obstructing the infrared LED 132. The guide rod 110 can slide through the inner diameter of the guide tube 92 of the end effector 90 to axially lock the assembly to the end effector. In an alternative design, the connection to the robot 82 can be built into the guide rod 110 instead of being connected through the end effector 90.

[0100] Once the guide rod 110 snaps in and is axially locked, assembly 100 can rotate about end effector 90 until the planned horizontal plane is parallel to navigation sleeves 120, 122. Marker 108 is identified by camera system 94 to indicate the angle of deviation from the plane, and when the mark is at 0°, guide rod 110 can be finally locked. After rotatably locking guide rod 110, the width of guide rod assembly 102 can be manually adjusted to match the width of the anterior outriggers, and then the angles of navigation sleeves 120, 122 can be adjusted to conform to preoperative planning, sizing, and positioning. The axes of navigation sleeves 120, 122 can be aligned with the center-lateral angle of lateral outriggers 20, 22 as identified in the planning overview. Navigation sleeves 120, 122 can be finally locked to ensure guide rod and navigation sleeve stiffness before forward movement to depth control.

[0101] Working using an outside-in approach, decompression can begin removal of the bilateral facet joints. For example, safety and protective measures can be taken to exit the neuron by setting adjustable stops 160, 162 to their initial depth. Depth control can be set according to the plan and remains independent of the left and right trajectories for customized access to anomalous patient anatomy. An alternative design for this manual setting is to power a single-position dual-gate end effector that automatically generates width, angulation, and adjustable depth control settings based on the preoperative plan.

[0102] The third step in the workflow may include tubular access and decompression or alternative direct visualization ports. Surgeon comfort using the tubular approach remains variable compared to direct visualization when removing posterior anatomical structures and protecting neurons anterior to the facet joints. To accommodate this, alternative workflows consisting of direct visualization ports 194 can be utilized in conjunction with the guide rod system 102, in addition to the tubular access and decompression workflow. A combination of high-speed bone drills, oscillating drills, and manual bone chisels can be used to enhance comfort for surgeons from diverse technical backgrounds and training levels. Alternative workflows maintain the same planned trajectory and offer the benefits of each workflow.

[0103] The MIS access workflow utilizing navigation cannulas 120 and 122 provides tubular access and decompression benefits, including: (1) depth control compatibility; (2) navigation cannula compatibility with expanders, eccentric sheaths, docking facet expanders, and instruments; (3) reduced posterior structural anatomy; and (4) streamlined for immediate insertion of the intervertebral body cannula. The direct visualization access workflow utilizing port 194 can have a cone-shaped angle. Direct visualization provides increased visualization for thorough decompression, and increased visualization increases safety regarding neurons.

[0104] The fourth step in the workflow may include the insertion of a double-door implant cannula. After thorough access and decompression have adequately removed all obstructing bone from the bilateral tracks, regardless of the access workflow used, the navigation cannulas 120, 122 can be used with adjustable stops 160, 162 locked to their lowest height for implant cannula insertion. The implant cannula 230 can be adjusted to the planned depth according to the plan, and then the cannula dilator 242 can be loaded into the keying feature 248 at the distal tip 238 of the cannula 232. The proximal end of the cannula dilator 242 can be impacted until the cap 242 impacts the face of the navigation cannulas 120, 122, and the implant cannula 230 is simultaneously locked into the navigation cannulas 120, 122 at the planned depth. The cannula dilator 242 can be removed to begin the discectomy.

[0105] The fifth step in the workflow may include discectomy. Once the implant cannula 230 is inserted and axially locked, discectomy can be performed through the implant cannula 230 to improve the efficiency and overall quality of soft tissue removal. This results in easier intervertebral body insertion and positioning, and increases the volume of bone graft in the intervertebral disc space to promote faster fusion. A heat map can be automatically generated based on the intervertebral body placement to calculate the volume area where the tool can and should be placed to remove soft tissue.

[0106] The discectomy instrument 250 utilizes navigation to track placement and articulation at the distal tip 260 to confirm soft tissue removal and endplate preparation within the automatically generated volumetric space of the disc. The array spheres 268 track the mechanical articulation according to a customized array positioning. This enhances discectomy by aiding in confirmation of placement and orientation. The robot 82 can also read areas that the tool path has traversed or has not yet traversed to ensure sufficient soft tissue removal and prepared endplate surface area.

[0107] Dual-gate guided discectomy offers technical variability, allowing surgeons to choose between a guided manual instrument 250, a powered discectomy instrument 270, or a combination of both. Both techniques can be performed via manual endplate preparation to help ensure increased fusion rate and validate instrument transfer throughout the automatically generated volumetric thermogram.

[0108] The sixth step in the workflow may include intervertebral body deployment and positioning. After complete discectomy, the three-legged intervertebral body 12 can be positioned by: inserting the intervertebral body 12 through the ipsilateral implant cannula 230; using cable 292 to pull the contralateral outrigger 20 to the contralateral implant cannula 230; and connecting the second insert 302 through the contralateral implant cannula 230. The three outriggers 20, 22, and 24 are connected by two hinge pins 26 and the cable assembly 292 is threaded onto the contralateral outrigger 20. Magnets pull the intervertebral body 12 into its natural U-shaped position, wherein the proximal ends of the lateral outriggers 20 and 22 are connected to the inserts 300 and 302 through the implant cannula 230.

[0109] After the articulated magnet retrieval tool 290 connects through the contralateral implant cannula 230 and pulls the coiled end of the cable assembly 292, the cable 296 can be placed under tension because the contralateral insert 300 is rigidly connected to the lateral support leg 22. The rigidity of the insert connection can be checked before the proximal threaded cap 298 is unscrewed from the intervertebral body 12 to release the cable assembly 292 from the intervertebral body 12.

[0110] Once inserts 300 and 302 are connected to the lateral outriggers 20 and 22, the navigable array 308 can be attached to inserts 300 and 302 for precise placement of the intervertebral body 12, achieving excellent segmental correction and stability. Views from the sagittal, axial, and coronal planes, as well as 3D volumetric views, enhance the surgeon's ability to place the intervertebral body 12 in the planned position with dual insert control. The trajectory can be locked due to preoperative planning and guide bar setup, but the depth and orientation of the anterior outrigger 20 and lateral outrigger 22 can be confirmed using navigation prior to extension.

[0111] Once the collapsed intervertebral body 12 is accurately positioned, the actuator 310 can be placed in and axially clamped to both the ipsilateral insert 300 and the contralateral insert 302. Arrays and / or smart instruments can be used to read out the parallel post-anterior lordosis extension for both the left and right sides. Similar to the rest of the procedure, the planning overview outlines the target height of the expandable implant, lordosis, and coronal correction.

[0112] The seventh step in the workflow may include installing the nitinol fixation assembly 14. Due to the superior segmental correction from the intervertebral body stabilizing device 12 and the increased contact between the cortical bone on the annulus fibrosus and the intervertebral body endplate, the inferior pedicle-based pedicle fixation device 14 can be centrally deployed to the planned lateral supports 20, 22 of the intervertebral body. The hyperelasticity of nitinol allows the material to be drawn from its bent state into a straight deployment tube 324. The device 320 can load nitinol into the straight deployment tube 324 by drawing nitinol from the threaded proximal end 48. The deployment tube 324 is customized for specific product sizes because the bend diameter or head-to-tail height of the nitinol rod 40 has a rod thickness proportional to its strength to improve the hyperelastic properties.

[0113] Before the end effector 90 is moved onto the planned trajectory for fixation deployment, navigation prompts the surgeon to re-register with sagittal and coronal C-arm shots to account for segmental corrections and displacement of the lower and upper vertebrae 2 due to intervertebral body extension. Once re-registered, the preoperative plan for the Nitinol fixation device 14 can be confirmed and / or modified to suit the modified patient anatomy. Once the plan is set, the end effector 90 is moved into place, and a power-operated pedicle preparation drill can be used to drill a hole into the lower pedicle 8 at the planned depth of the deployment device 320. The Nitinol deployment device 320 is then lowered into the end effector 90 and locked into the axial locking cap 130 after the guide rod assembly 102 has been removed.

[0114] The nitinol rod 40 can be positioned in the preparation hole, locked into the end effector 90, and prepared for clamping for deployment. The hyperelastic properties of the nitinol allow it to return to its natural curvature throughout deployment, sweeping across the inferior pedicle 8, through the intervertebral disc space 4, centered laterally towards the intervertebral body legs 20, 22, and into the superior vertebral body 6. After the clamping cap 336 is lowered to its lowest point and the rod 40 is fully deployed, the instrument 320 can be removed. The pedicle screw 42 can be inserted and driven onto the proximal thread 48 of the nitinol rod 40 to grip the existing cortical bone in the pedicle 8 and anchor the proximal end 44 of the nitinol rod 40 to the inferior pedicle 8. Additional features are available for locking the screw 42 to the nitinol rod 40, such as a snap-fit ​​ring in the pedicle screw 42 for engaging with the external groove of the nitinol rod 40. The process of installing a second nitinol fixation assembly 14 can be repeated for the contralateral side.

[0115] The eighth step in the workflow may include final verification. After the fixation device 14 is deployed and assembled, final verification can be used to ensure that the final construct achieves the preoperative planned target position and segmental correction in the sagittal and coronal planes. The complete construct provides excellent stability according to the posterior approach, and the fixation device 14 does not damage the superior facet joints, thereby limiting disease in adjacent segments.

[0116] Robotically-enabled procedures utilize imaging, navigation, and robotics to enhance the quality and efficiency of posterior procedures through planned and navigable instruments. Overall, the procedure reduces radiation exposure compared to conventional surgery. Dual-door components and discectomy instruments provide safe and repeatable direct decompression within the access window of the tubular approach. The discectomy instruments increase the percentage of soft tissue removed to enlarge the volume area available for intervertebral body placement and bone grafts. Segmental correction from the intervertebral body stabilizing device, along with independently controlled sagittal and coronal correction, provides increased stability from increased endplate contact along the annulus annulus. Posterior MIS nitinol fixation implants avoid damage to the superior facet joints and potential iatrogenic effects that could result from bilateral pedicle structures.

[0117] Although the invention has been described in detail and with reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention. Therefore, it is intended that the invention cover modifications and variations thereof, provided that such modifications and variations fall within the scope of the appended claims and their equivalents. For example, it is expressly intended that all components of the various devices disclosed above be combined or modified in any suitable configuration.

Claims

1. A system for enabling a two-door robot, comprising: A robot system comprising: a base including a computer; a display electrically coupled to the computer; a robot arm electrically coupled to the computer and capable of movement based on commands processed by the computer; an end effector having a guide tube electrically coupled to the robot arm, the guide tube having a central longitudinal axis; and a camera configured to detect one or more tracking markers; and A dual-door assembly comprising: a guide rod assembly supporting a first navigation cannula assembly and a second navigation cannula assembly, the guide rod assembly including a central guide rod configured to be inserted into the guide tube; and a first lateral wing and a second lateral wing positioned on opposite sides of the guide rod, the first and second navigation cannula assemblies each including a hollow tubular cannula configured to guide an instrument placed through the respective cannula along a desired entry trajectory to the surgical area; The first and second navigation cannula assemblies are each configured to be independently angled relative to the central longitudinal axis of the guide tube, thereby providing the desired entry trajectory to the surgical area; and The first lateral wing supports the first navigation sleeve assembly via a first support arm, and the second lateral wing supports the second navigation sleeve assembly via a second support arm.

2. The system of claim 1, wherein the dual-door assembly is configured to pivot about the central longitudinal axis of the guide tube of the end effector.

3. The system of claim 1, wherein the width between the sleeves of the first navigation sleeve assembly and the second navigation sleeve assembly is adjustable.

4. The system of claim 1, wherein the dual-door assembly includes a plurality of tracking markers configured to monitor the guide rod assembly and the first navigation sleeve assembly and the second navigation sleeve assembly, thereby providing navigation and / or robot assistance.

5. The system of claim 1, wherein the first lateral wing and the second lateral wing each include an elongated slot, and the navigation sleeve assembly slides along the respective slot to adjust the width between the sleeves and / or the angle of the sleeves.

6. The system of claim 1, wherein the guide rod is configured to slide into the guide tube of the end effector and be axially locked to the guide tube using an axial locking cap.

7. The system of claim 6, wherein the axial locking cover includes a locking button configured to engage with a groove on the guide rod.

8. The system of claim 1, wherein the rotational movement of the guide rod assembly can be locked using a center wheel handle lock.

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