Robotic spine systems and robotically assisted methods for tissue adjustment

Abstract

Various implementations of systems and methods for accessing and adjusting tissue (e.g., systems and methods for accessing and ablating nerves or other tissue within or around a vertebral body to treat chronic low back pain) are described herein. In some embodiments, assessment of vertebral endplate degeneration or defects (e.g., premodic changes) to facilitate identification of treatment sites and protocols is also provided. Some embodiments include, by way of example, robotic elements to facilitate robotically controlled access, navigation, imaging, and / or treatment.

Description

[Technical Field]

[0001] (Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 161,058, filed March 15, 2021, the entire contents of which are incorporated herein by reference.

[0002] Various implementations of systems and methods for adjusting tissue (e.g., systems and methods for ablating nerves or other tissue within or around vertebral bodies to treat chronic low back pain) are described herein, with some embodiments including, by way of example, robotic elements to facilitate robotically controlled access, navigation, imaging, and / or treatment. Augmented reality and virtual reality environments are also contemplated. [Background technology]

[0003] Back pain is a very common health problem worldwide and a leading cause of work-related disability benefits and compensation. At any given time, back pain affects nearly 30% of the U.S. population and results in 62 million annual visits to hospitals, emergency departments, outpatient clinics, and physicians' offices. Back pain can result from tense muscles, ligaments, or tendons in the back, and / or structural problems with the bones or intervertebral discs. Back pain can be acute or chronic. Existing treatments for chronic back pain vary widely and include physical therapy and exercise, chiropractic treatment, injections, rest, pharmacological therapies such as opioids, analgesics, or anti-inflammatory medications, and surgical interventions such as spinal fusion, discectomy (e.g., total disc replacement), or disc repair. Existing treatments are costly, addictive, temporary, potentially ineffective, and / or can increase pain or require long recovery times. Furthermore, existing treatments do not provide adequate relief for most patients, and only a small proportion are surgically eligible.

[0004] To facilitate the performance of various surgical procedures, such as inserting pedicle screws into the spine in conjunction with surgical spinal fusion, robotic systems for performing the surgical procedures have been developed. Summary of the Invention

[0005] Applicant's existing technology (Intracept® treatment by Relievant®) provides a safe and effective minimally invasive procedure that targets the basal nerves for the relief of chronic vertebral low back pain. As disclosed herein, some example systems, devices, and methods provide bone access tools, additional modalities of relief for patients, and / or ancillary techniques, as well as, in certain implementations, robotic elements to facilitate, by way of example, robotically controlled access, navigation, imaging, and / or treatment within the vertebral bodies of the spine.

[0006] In some implementations, automated systems for accessing and / or treating tissue (such as nerves) are provided. According to some examples, robot-enabled or robot-controlled surgical, access, and / or treatment tools can provide a high level of control and precision of movement, increased dexterity, and range of motion, thereby providing increased assurance that damage will not occur to tissue that is not desired to be affected. Robotic systems can be integrated or paired with augmented reality systems or devices. Robotic-controlled tools and technology (e.g., computer-assisted tools and technology that may incorporate artificial intelligence learning and feedback) can also be used to facilitate navigation to and surgical procedures at desired target treatment areas that may be difficult to access manually (e.g., minimally invasive neuromodulation procedures), thereby providing increased flexibility and capabilities that would be impossible with manual human surgery. Robotic-controlled tools and technology (e.g., computer-assisted tools and technology that may incorporate artificial intelligence learning and feedback) can further be used to facilitate pre- or intraoperative image capture without exposing the target treatment area to radiation or requiring large incisions. Nerve detection devices (e.g., nerve monitors or nerve finders) may also be used to detect nerves along the access path that are desired to be avoided during access. Robotic or automated tools and techniques may reduce the number and size of incisions (and therefore scarring), reduce blood loss, reduce pain, and shorten recovery time. Robotic systems may also result in reduced time spent waiting to rotate a C-arm imager back and forth between different views, as may be required in some implementations during manual insertion of tools.

[0007] The treatment procedure may include modulation of nerves within or around bone. As used herein, the terms "modulation" or "neuromodulation" should be given their ordinary meaning and should also include ablation, permanent denervation, temporary denervation, destruction, blockage, inhibition, electroporation, therapeutic stimulation, diagnostic stimulation, blockage, necrosis, desensitization, or other effects on tissue. Neuromodulation refers to the modulation of nerves (structurally and / or functionally) and / or nerve transmission. Modulation is not necessarily limited to nerves, but may include effects on other tissues, such as tumors or other soft tissues.

[0008] According to some examples, a method for ablating basal nerves and / or other intraosseous nerves within a vertebral body includes inserting an access assembly into the vertebral body using a robotic control system integrated with an augmented reality system. The access assembly includes at least one cannula. The method further includes inserting a radiofrequency energy delivery device through the cannula to a target treatment site within the vertebral body using the robotic control system and the augmented reality system, and applying power to the target treatment site using the radiofrequency energy delivery device sufficient to ablate the basal nerve.

[0009] According to some examples, a robotic-assisted method for ablating basal nerves and / or other intraosseous nerves within a vertebral body includes providing a desired trajectory for accessing a target treatment site within the vertebral body to a computer-based control system of a robotic system including one or more robotic arms. The method further includes coupling a bone access tool to the one or more robotic arms of the robotic system and controlling insertion of the bone access tool into the vertebral body through skin adjacent to the vertebral body using the robotic system. The bone access tool may include an introducer cannula. Controlling insertion of the bone access tool includes using an augmented reality device including a see-through optical head-mounted display and one or more input devices communicatively coupled to the robotic system. The method also includes inserting a radiofrequency energy delivery device through the introducer cannula to the target treatment site within the vertebral body and applying radiofrequency energy to the target treatment site using the radiofrequency energy delivery device sufficient to ablate the basal nerves and / or other intraosseous nerves within the vertebral body.

[0010] The desired trajectory may be generated automatically by a computer program or may be determined by a surgeon or other clinical professional. The bone access tool may include markers to facilitate alignment of the bone access tool by a tracking system of the robotic system.

[0011] The one or more input devices may include one or more joysticks or handheld controllers, batons, or remotes. The one or more joysticks or other input devices may be communicatively coupled to the augmented reality device (directly or indirectly via a robotic system).

[0012] The desired trajectory may be displayed as a virtual image on the display of the augmented reality device. The virtual image may be overlaid or superimposed on an anatomical image (e.g., a 2D or 3D image) of the patient. In some implementations, the desired trajectory is configured to terminate in a region that includes the basal nerve trunk.

[0013] The desired trajectory may be determined based on preoperative imaging of the spinal anatomy surrounding and including the vertebral body. The desired trajectory may be determined based on specific characteristics of the vertebral body (e.g., bone structural characteristics such as bone density, or anatomical identification of the vertebral body by vertebral level and number, such as L4, L5, S1, S2, etc.). In some implementations, controlling insertion of the bone access tool includes responding to haptic feedback provided by a robotic system.

[0014] The augmented reality system may include a headset or eyewear (e.g., goggles or glasses) device configured to be worn by a surgeon (e.g., an orthopedic surgeon or other clinician). The augmented reality device may alternatively comprise a tablet or portal that can be coupled to the arm of a robotic system or to a patient's operating table or stand, thereby allowing the tablet or portal to be positioned directly above the target treatment site. The augmented reality device may include a see-through display configured to display a virtual image overlaid or superimposed on the surgical tools and the patient's real-time field of view, thereby eliminating the need for the orthopedic surgeon to turn their head to view one or more displays or written treatment instructions outside the treatment field of view. The virtual image may provide surgical or procedural guidance. The virtual image may include a real-time video feed (e.g., fluoroscopy or computed tomography image guidance) of the target treatment site (such as a vertebral body), a planned virtual trajectory or path indicator, icon, or image, 2D, 3D, or 4D pre-operative anatomical image (e.g., magnetic resonance image or computed tomography image), and / or alphanumeric content (e.g., treatment instructions, cautions, alarms, warnings, real-time or previously acquired characteristics (e.g., heart rate, bone density measurements, vertebral body level indicators or labels (e.g., L4, L5, S1), and / or real-time treatment parameters (e.g., impedance measurements, treatment duration timer, temperature measurements, power output measurements), etc.).

[0015] The surgeon may also input text or annotations into the display of the augmented reality device using voice-activated commands, via a virtual touchscreen keyboard on the display, or via one or more joysticks or other handheld controllers wirelessly coupled to the augmented reality device. The inputted text or annotations may be reproduced on other displays in the hospital operating room, outpatient operating room, or outpatient procedure room for viewing by others. The inputted text or annotations may be recorded and stored along with intraoperative video or still images (e.g., for documentation or follow-up purposes). The annotations and video or still images may be captured and stored on a cloud server system or other proprietary physical server system. The augmented reality device may also enable the surgeon to perform procedures from a remote location via a communications network. The augmented reality device may be communicatively coupled to a robotic control system so that the surgeon can control the operation of the robotic control system in person or remotely.

[0016] In some implementations, the robotic control system includes one or more robotic arms and a surgeon control console including at least one processor. The system may include one or more imaging devices configured to provide feedback (e.g., based on artificial intelligence processing algorithms) to the robotic control system to control insertion of the access assembly and / or radiofrequency energy delivery device, and / or to control neuromodulation parameters (e.g., ablation parameters), or to determine the location of a desired target treatment site to facilitate optimal treatment.

[0017] The robotic control system may include one or more robotic arms. The one or more robotic arms may have at least six degrees of freedom. The robotic control system may include a surgeon control console with at least one processor. The robotic control system may further include one or more imaging devices configured to provide feedback to the robotic control system to control the insertion and / or operation of the access assembly and / or radiofrequency energy delivery device. The one or more imaging devices may be carried by one or more robotic arms of the robotic control system. In some cases, the robotic control system controls the insertion and / or operation of the access assembly and / or radiofrequency energy delivery device using a closed-loop system. In some cases, the robotic control system changes the configuration of the radiofrequency energy delivery device (e.g., to adjust a target treatment location or treatment or operation parameters).

[0018] The method may also include displaying a desired trajectory directed toward the target treatment site within the vertebral body on a display to a user of the robotic control system. The method may further include receiving input from the user to modify the desired trajectory directed toward the target treatment site. The display may be a display on an augmented reality device (e.g., a headset or eyewear, such as augmented reality glasses, or an augmented reality tablet or portal device).

[0019] According to some examples, a system for facilitating nerve ablation includes a surgeon control console with a computer-based control system including at least one processor configured to execute program instructions stored on a non-transitory computer-readable medium to perform a nerve ablation procedure using an automated robotic surgical arm to ablate basal nerves and / or other intraosseous nerves within one or more vertebral bodies. The system also includes one or more robotic surgical arms configured to move with six or more degrees of freedom and to support or carry an access tool, treatment device, and / or diagnostic device. The system further includes a tracking system that can be used to capture the position of at least a portion of the patient, the access tool or treatment device, and the one or more robotic surgical arms. The tracking system may include one or more imaging devices configured to acquire images of the target treatment site and / or one or more sensors, tracking devices, or markers (e.g., optical sensors, electromagnetic sensors, LIDAR sensors, infrared sensors, ultrasonic sensors, force sensors, motion sensors, proximity sensors) to facilitate detection or position tracking and / or alignment. The robotic system also includes a display, and the computer-based control system is configured to display a desired trajectory directed to a target treatment site within the vertebral body for performing the nerve ablation procedure.

[0020] In some examples, the one or more imaging devices are carried by one or more robotic surgical arms of the system. In some examples, the one or more robotic surgical arms are carried by a mobile cart. The computer-based control system may use a closed-loop system to control the insertion of the delivery access tool, treatment device, and / or diagnostic device. The system may further include a display, wherein the computer-based control system is configured to display a desired trajectory aimed at a target treatment site within the vertebral body. In some configurations, the computer-based control system is configured to receive input from a user to modify the desired trajectory aimed at the target treatment site. The computer-based control system may be configured to display an actual image and / or graphical representation of the access tool, treatment device, and / or diagnostic device over an actual image and / or graphical representation of the target treatment site.

[0021] In some examples, the display comprises a see-through display on an augmented reality or virtual reality device (e.g., a headset, goggles, glasses, eyewear, a computer tablet, or a portal), and the robotic system is configured for a user to operate in the augmented reality or virtual reality environment. The operator control console may comprise the augmented reality device.

[0022] In some configurations, the robotic system includes a surgical instrument guide configured to be coupled to one or more robotic surgical arms to facilitate guided insertion of an access tool or treatment device along a desired trajectory. In some configurations, the computer-based control system uses a closed-loop system to control the automated insertion of the access tool or treatment device. In some configurations, the closed-loop system incorporates feedback based on one or more trained neural networks.

[0023] According to some implementations, a robotic-assisted method for ablating basal and / or other intraosseous nerves within a vertebral body includes positioning a surgical instrument guide along a trajectory directed toward a target treatment site within the vertebral body using a robotic control system. The method also includes inserting an access assembly into the vertebral body through the surgical instrument guide. The method further includes inserting a radiofrequency energy delivery device through the access assembly to the target treatment site within the vertebral body, and applying, using the radiofrequency energy delivery device, power (e.g., a thermal treatment dose) to the target treatment site sufficient to ablate the basal and / or other intraosseous nerves.

[0024] In some implementations, the robotic control system includes one or more robotic arms. The one or more robotic arms may have at least six degrees of freedom. However, other degrees of freedom may be used. The robotic control system may include a surgeon control console including at least one processor. The system may also include one or more imaging devices configured to provide feedback to the robotic control system to control the insertion and / or operation of the access assembly and / or radiofrequency energy delivery device. In some implementations, the one or more imaging devices are carried by one or more arms of the robotic control system. In some implementations, the robotic control system controls the insertion and / or operation of the access assembly and / or radiofrequency energy delivery device using a closed-loop system. The closed-loop system may incorporate feedback based on artificial intelligence algorithms implementing one or more trained neural networks.

[0025] The trajectory may be automatically determined by the robotic control system based on (i) preoperative images of the vertebrae corresponding to the vertebral bodies and surrounding patient anatomy, (ii) the position of the vertebral bodies, and / or (iii) patient-specific characteristics associated with the vertebral bodies.

[0026] In some configurations, the trajectory is configured to terminate in a region that includes the basal nerve trunk. The trajectory may include one or more path subcomponents, and the various subcomponents may be straight or curved.

[0027] The preoperative images may include magnetic resonance images or computed tomography images of a portion of the patient's spine. Additionally or alternatively, intraoperative images (e.g., fluoroscopic images) may be used. The location of the vertebral body may include identification of whether the vertebral body is lumbar or sacral, and the particular level of the vertebra (e.g., L5, L4, L3, S1, S2). The patient-specific characteristics may include, for example, bone mineral density measurements of one or more vertebral bodies of the patient.

[0028] In some implementations, the trajectory is determined by a user (e.g., a surgeon or other clinical expert) based on at least preoperative images of the vertebral bodies.

[0029] In some examples, the method also includes displaying a desired trajectory directed toward the target treatment site within the vertebral body to a user of the robotic control system. The method may also include receiving a command from the user to change the desired trajectory directed toward the target treatment site.

[0030] In some examples, the method further includes manually inserting an access assembly into the vertebral body via the surgical instrument guide and / or manually inserting a radiofrequency energy delivery device to a target treatment site within the vertebral body via the access assembly. The method may include automatically adjusting, via the robotic control system, the position of the surgical instrument guide based on changes in the position of the vertebral body such that a spatial relationship between the surgical instrument guide and the vertebral body remains substantially unchanged as at least a portion of the operation of ablating the basilar nerve and / or other intraosseous nerve is performed.

[0031] According to some examples, a system for facilitating nerve ablation includes a surgeon control console with a computer-based control system including at least one processor configured to execute program instructions stored on a non-transitory computer-readable medium to perform a nerve ablation procedure using an automated robotic surgical arm to ablate basal nerves and / or other intraosseous nerves within one or more vertebral bodies. The system also includes a robotic surgical arm configured to move with at least three degrees of freedom and to support a surgical instrument guide. The system further includes a tracking system for capturing the position of the robotic surgical arm, and an access assembly and / or a radiofrequency energy delivery device configured to be inserted through the surgical instrument guide.

[0032] In some configurations, the computer-based control system is configured to provide feedback to a user to control insertion and / or operation of the access assembly and / or radiofrequency energy delivery device. In some exemplary configurations, the computer-based control system controls insertion and / or operation of the access assembly and / or radiofrequency energy delivery device using a closed-loop system. The computer-based control system can be configured to display to a user of the system on a display a desired trajectory directed toward a target treatment site within a vertebral body.

[0033] According to some implementations, a method for facilitating nerve ablation in a patient includes generating, by a computer system having at least one processor, a virtual trajectory, the virtual trajectory being a virtual axis, the virtual axis being a three-dimensional digital representation indicating a position, orientation, or combination thereof for advancing one or more physical surgical tools or instruments toward a treatment site. The method also includes displaying, using a display, a position, orientation, or combination thereof of the virtual surgical axis on a representation of a portion of the patient's anatomy to superimpose the virtual trajectory on the patient's anatomy, the display of the position, orientation, or combination thereof of the virtual axis being configured to be maintained by the computer system in relation to the one or more anatomical structures as the patient moves, the one or more anatomical structures being registered to a coordinate system, and the virtual axis being registered to the coordinate system.

[0034] In some implementations, the method further includes displaying the virtual axis with a see-through optical head-mounted display aligned to the coordinate system. The method may further include inserting a surgical tool into a vertebral body of the patient along the virtual trajectory and ablating a basal nerve trunk in the vertebral body of the patient.

[0035] According to some implementations, a system for facilitating nerve ablation in a patient includes at least one processor, at least one display, and at least one user interface. The system is configured to generate a virtual trajectory, the virtual trajectory being a virtual axis, the virtual axis being a three-dimensional digital representation illustrating a desired path of insertion of multiple instruments toward a target site within a vertebral body, the target site corresponding to a location of a basal nerve trunk within the vertebral body.

[0036] According to some examples, a system for facilitating nerve ablation includes a surgeon control console with a computer-based control system including at least one processor configured to execute program instructions stored on a non-transitory computer-readable medium to perform a nerve ablation procedure using automated robotic surgical arms to ablate basal nerves within one or more vertebral bodies. The one or more robotic surgical arms are configured to move with six or more degrees of freedom and to support or carry bone access tools (e.g., cannulas, stylets, bone drills, curettes), treatment devices (e.g., radiofrequency probes, microwave ablation catheters, ultrasound probes), and / or diagnostic devices (e.g., cameras, sensors, etc.). The system may optionally include one or more imaging devices configured to acquire images of the target treatment site before, during, and / or after the treatment procedure.

[0037] According to some examples, a method for ablating basal nerves and / or other intraosseous nerves within a vertebral body includes inserting an access assembly (e.g., a bone access introducer cannula and / or stylet) into the vertebral body using a robotic control system. The method also includes inserting an ablation device (e.g., a radiofrequency energy delivery device, a microwave energy delivery device, a laser energy delivery device, an ultrasound energy delivery device, a thermal energy delivery device, a cryoablation device, a chemical ablation device, a steam or vapor delivery device) through the cannula to a target treatment site within the vertebral body using the robotic control system, and providing treatment (e.g., applying power) to the target treatment site using the ablation device sufficient to ablate the basal nerves and / or other intraosseous nerves.

[0038] According to some implementations, a method for facilitating ablation of basal nerves within a vertebral body includes applying radiofrequency energy to a location within the vertebral body according to the following treatment parameters: a frequency of 400 kHz to 600 kHz (e.g., 400 kHz to 500 kHz, 450 kHz to 500 kHz, 470 kHz to 490 kHz, 500 kHz to 600 kHz, overlapping ranges thereof, or any value within the recited ranges), a target temperature of 80°C to 90°C (e.g., 80°C, 85°C, 90°C), a temperature gradient of 0.5°C to 3°C per second (e.g., 0.5°C per second, 1°C per second, 1.5°C per second, 2°C per second, 2.5°C per second, 3°C per second), and an active energy delivery time of 10 to 20 minutes (e.g., 10 minutes, 12 minutes, 14 minutes, 15 minutes, 16 minutes, 18 minutes, 20 minutes). In some implementations, the targeted ablation zone has a major dimension along the major axis of 20 mm to 30 mm and a minor dimension along the minor axis of 5 mm to 15 mm. According to some examples, a robotic-enabled or robotically-controlled surgical system can be configured to position and / or operate a probe to facilitate ablation of the basal nerve within a vertebral body in accordance with the methods described above.

[0039] According to some configurations, a kit for facilitating nerve ablation includes one or more biological assays configured to determine at least one biological marker (e.g., cytokine, substance P or other indicator of pain, heat shock protein). The determination includes at least one of binary detection of the presence of the at least one biological marker and / or quantification (e.g., total amount) of the at least one biological marker. The determination may also optionally include displaying the location of any of the at least one biomarker or the location of the highest concentration of the at least one biomarker. According to some configurations, the robotic-enabled or robotic-controlled surgical system is configured to acquire and / or display images and / or measurements from the patient before and after treatment and may compare the presence of one or more biomarkers in pre- and post-treatment samples to confirm treatment effectiveness. The comparison may include comparing the level or activity of the biomarkers in the samples and displaying such results to a user using the robotic surgical system.

[0040] The kit may optionally include one or more bone access tools (e.g., stylet, cannula, curette, bone drill) configured to access the target nerve (e.g., basal nerve) to be treated. The kit may also, or alternatively, include one or more treatment tools configured to modulate (e.g., ablate, stimulate, denervate, inhibit, necrotize, electroporate, molecular dissociate) the target nerve. Optional treatment tools include one or a combination of radiofrequency energy delivery devices, microwave energy delivery devices, ultrasound energy delivery devices, cryogenic conditioning devices (e.g., cryoablation devices), laser energy delivery devices, and / or drug elution devices (e.g., chemical or fluid ablation devices configured to elute a fluid capable of denervating or ablating the nerve, such as alcohol or phenol). According to some configurations, a robot-enabled or robot-controlled surgical system can be configured to position a surgical guide instrument through which one or more bone access tools (e.g., stylet, cannula, curette, bone drill) can be inserted to access the target nerve (e.g., basal nerve) to be treated.

[0041] According to some implementations, a method for detecting and treating back pain in a subject includes acquiring an image of a vertebral body of the subject and analyzing the image to determine whether the vertebral body exhibits one or more symptoms associated with premodic changes. The method also includes modulating (e.g., ablation, denervation, stimulation) an intraosseous nerve (e.g., a basilar nerve) within the vertebral body if the vertebral body is determined to exhibit one or more symptoms associated with premodic changes. According to some configurations, a robotic-enabled or robotic-controlled surgical system can be configured to control the modulation.

[0042] The images may be 2D, 3D, or 4D images obtained using, for example, MRI, CT, X-ray, ultrasound, or fluoroscopy. The one or more symptoms associated with premodic changes may include characteristics likely to result in Modic changes (e.g., Type 1 Modic changes, Type 2 Modic changes). The one or more symptoms associated with premodic changes may include early signs or precursors of edema or inflammation in the vertebral endplate prior to formal characterization or diagnosis as Modic changes. The one or more symptoms may include edema, inflammation, and / or tissue changes within the vertebral body or along a portion of the vertebral endplate of the vertebral body. The tissue changes may include tissue lesions or changes in the tissue type or characteristics of the vertebral endplate and / or tissue lesions or changes in the tissue type or characteristics of the bone marrow of the vertebral body. The one or more symptoms may include focal defects, erosive defects, marginal defects, and corner defects in the vertebral endplate of the vertebral body.

[0043] The applied thermal treatment dose may include delivery of one or more of radiofrequency energy, ultrasound energy, microwave energy, and laser energy. Ablation of the basal nerve within the vertebral body may include applying a thermal treatment dose of at least 240 CEM to a location within the vertebral body using a cumulative equivalent unit ("CEM") at 43°C model. In some implementations, the thermal treatment dose is 200 to 300 CEM (e.g., 200 to 240 CEM, 230 to 260 CEM, 240 to 280 CEM, 235 to 245 CEM, 260 to 300 CEM), or greater than a predetermined threshold (e.g., greater than 240 CEM). The target thermal treatment dose may also be based on an Arrhenius model.

[0044] In some implementations, ablating the basal nerve within a vertebral body includes advancing at least a distal end of a radiofrequency energy delivery probe with two electrodes (e.g., a bipolar probe having an active electrode and a return electrode) to a target treatment location within the vertebral body and applying radiofrequency energy to the location using the energy delivery probe to generate a thermal treatment dose sufficient to modulate (e.g., ablate, denervate, stimulate) the intraosseous nerve (e.g., the basal nerve). The radiofrequency energy may have a frequency of 400 kHz to 600 kHz (e.g., 400 kHz to 500 kHz, 425 kHz to 475 kHz, 450 kHz to 500 kHz, 450 kHz to 550 kHz, 475 kHz to 500 kHz, 500 kHz to 600 kHz, overlapping ranges thereof, or any value within the recited ranges). In some cases, the thermal treatment dose is configured to achieve a target temperature at the location of 70°C to 95°C (e.g., between 70°C and 85°C, between 80°C and 90°C, between 85°C and 95°C, overlapping ranges thereof, or any value within the recited range). The thermal treatment dose may be delivered at a temperature gradient of 0.1 to 5°C per second (e.g., 0.5 to 1.5°C per second, 1 to 2°C per second, 1.5 to 3°C per second, 0.5 to 3°C per second, 1.5 to 5°C per second, overlapping ranges thereof, or any value within the recited ranges. In some implementations, the temperature gradient is greater than 5°C per second. The radiofrequency energy may be applied for an active energy delivery time of 5 to 30 minutes (e.g., 5 to 15 minutes, 10 to 20 minutes, 15 to 30 minutes, overlapping ranges thereof, or any value within the recited ranges). The thermal treatment dose may form a target lesion area at the target treatment location having a maximum cross-sectional dimension of less than 15 mm. In some implementations, the radiofrequency energy delivery probe is controlled and operated by a surgical robotic system.

[0045] Ablating the basal ganglia may include creating a target ablation zone formed by a lesion having a "football" or elliptical profile shape. Ablating the basal ganglia may include creating a target ablation zone having a maximum cross-sectional dimension (e.g., diameter, height, width, length) of less than 15 mm. In some implementations, ablating the basal ganglia includes creating a target ablation zone having a maximum cross-sectional dimension along its major axis (e.g., major diameter) of 20 mm to 30 mm and a maximum cross-sectional dimension along its minor axis (e.g., minor diameter) of 5 mm to 15 mm.

[0046] In some implementations, the method is performed without the use of a cooling fluid. The method may further include modulating (e.g., ablat- ing, denervating, stimulating) an intraosseous nerve (e.g., a basilar nerve) within a second vertebral body above or below the first vertebral body.

[0047] According to some implementations, a method for detecting and treating back pain in a subject includes identifying a candidate vertebral body for treatment based on a determination that the vertebral body exhibits one or more symptoms or defects associated with vertebral endplate degeneration, and ablating basal nerves within the identified candidate vertebral body by applying a thermal treatment dose of at least 240 CEM to a location within the vertebral body using a cumulative equivalent dose ("CEM") in a 43°C model. The one or more symptoms associated with vertebral endplate degeneration or defects include premodical alteration characteristics.

[0048] In some embodiments, the determination is based on an image of the candidate vertebral body (e.g., an MRI image, a CT image, an X-ray image, a fluoroscopic image, an ultrasound image). In some embodiments, the determination is based on obtaining biomarkers from the subject. The biomarkers may be obtained, for example, from one or more serum samples (e.g., plasma). The biomarkers may be obtained over an extended period of time (e.g., a period of days, weeks, or months) or at a single time instance. In some embodiments, the image of the candidate vertebral body is displayed on a display of the robotic surgical system.

[0049] In some implementations, the location of the applied thermal treatment dose is in the posterior half of the vertebral body. The location may include the geometric center of the vertebral body. The location may be at least 5 mm (e.g., at least 1 cm) from the posterior edge (e.g., posterior cortical aspect) of the vertebral body.

[0050] In some implementations, the method includes advancing at least a distal end of a bipolar radiofrequency energy delivery probe having two electrodes to the location. The method may further include forming a passageway through the pedicle into the vertebral body, then advancing at least the distal end of the bipolar radiofrequency energy delivery probe along the passageway to the location, and then applying a thermal treatment dose to the location using the bipolar radiofrequency energy delivery probe. In some implementations, the method includes advancing the bipolar radiofrequency energy delivery probe through a surgical guide instrument positioned by a robotic control system. In some implementations, the movement and / or position of the surgical guide instrument and / or the energy delivery probe are coupled to a robotic arm of a robotic surgical system.

[0051] In some implementations, the method further includes applying radiofrequency energy to a second location within a second vertebral body. The second vertebral body may be at a different vertebral level than the first vertebral body, or may be at an adjacent vertebra to the first vertebral body.

[0052] According to some configurations, an introducer system adapted to facilitate percutaneous access to a target treatment location (e.g., a vertebral body) within a bone includes an introducer cannula having a proximal handle and a distal elongated hypotube extending from the proximal handle. The system further includes an introducer stylet having a proximal handle and a distal elongated shaft extending from the proximal handle. The introducer proximal handle includes a central opening on its upper surface coupled to the lumen of the distal elongated hypotube to facilitate insertion of the introducer stylet into the central opening in the distal elongated hypotube of the introducer cannula. The introducer cannula proximal handle includes one or more slots configured to receive at least a portion of the introducer stylet proximal handle to facilitate engagement and alignment between the introducer stylet and the introducer cannula. The proximal handle of the introducer stylet includes an anti-rotation tab configured to be received in one of one or more slots to prevent rotation of the introducer stylet within the introducer cannula. The distal end of the distal elongate shaft of the introducer stylet includes a distal cutting tip and a scalloped portion proximal to the distal cutting tip to provide a gap between the outer diameter of the distal end of the distal elongate shaft and the inner diameter of the introducer cannula. According to some configurations, a robotic-enabled or robotically-controlled surgical system can be configured to introduce the introducer system through skin adjacent to the vertebral body and into a pedicle connected to the vertebral body. According to some configurations, a robotic-enabled or robotically-controlled surgical system can be configured to position a surgical guide instrument so that the introducer system can be inserted through the surgical guide instrument, through the skin adjacent to the vertebral body, and into a pedicle connected to the vertebral body.

[0053] In some configurations, the proximal handle of the introducer stylet further includes a push button that, when depressed, (a) disengages the anti-rotation tab, allowing rotation of the introducer stylet within the introducer stylet, and (b) allows removal of the introducer stylet from the introducer cannula. The proximal handle of the introducer stylet may include a ramp configured to provide mechanical assistance for removing the introducer stylet from the introducer cannula. The proximal handle of the introducer cannula may include a T-shaped or smoke stack-shaped design.

[0054] The introducer system may further include a curved cannula assembly. The curved cannula assembly may include a cannula including a proximal handle with a curved insertion slot and a distal polymer tube. The distal polymer tube may include a curved distal end having a preformed curve but configured to bend when placed under restraint (e.g., restraint by insertion through a straight introducer cannula). The curved cannula assembly may further include a stylet including a proximal handle and a distal elongate shaft. The distal elongate shaft includes a curved distal end having a preformed curve but configured to bend when placed under restraint (e.g., restraint by insertion into a cannula or bone tissue), and a distal channeling tip. The length of the curved distal end of the distal elongate shaft proximal to the distal channeling tip (e.g., spring plate or platform portion) may include a smaller cross-sectional circumferential profile than the full cross-sectional circumferential profile (e.g., the cross-sectional circumferential profile of the distal elongate shaft or portion near or adjacent to the distal channeling tip) such that there is a larger gap between the outer cross-sectional dimension of the curved distal end of the distal elongate shaft and the inner diameter of the curved distal end of the cannula along the length of the curved distal end of the distal elongate shaft proximal to the distal channeling tip. The less-than-full cross-sectional circumferential profile may include a "D" shape. Thus, the full cross-sectional circumferential profile may be asymmetric (e.g., not uniform or constant along its entire length).

[0055] The proximal handle of the stylet may include an actuation mechanism or means for actuation (e.g., a bail actuator, a threaded knob or screw actuation mechanism, a slide actuator, a pull wire actuator, a lever, a hydraulic actuator, a pneumatic actuator, an electric actuator, a push button actuator, a mechanical linear actuator). The actuation mechanism or means is adapted to cause axial movement (e.g., proximal movement upon actuation) of the distal channeling tip of the distal elongate shaft of the stylet relative to the cannula to facilitate insertion of the curved cannula assembly through the introducer cannula and withdrawal of the stylet of the curved cannula assembly from the cannula of the curved cannula assembly after forming a curved pathway within the bone.

[0056] According to some implementations, a method for accessing a target treatment location within a vertebral body identified as having bone includes advancing an introducer assembly through skin adjacent to the vertebral body and into a pedicle connected to the vertebral body, the introducer assembly including an introducer stylet inserted into an introducer cannula, with a distal cutting tip of the introducer stylet extending from the introducer cannula. The method further includes removing the introducer stylet from the introducer cannula, leaving the introducer cannula in place. The method also includes inserting an introducer drill through the introducer cannula, past the introducer cannula, through the pedicle, and into the cancellous bone of the vertebral body. Inserting the introducer drill includes rotating the introducer drill. The introducer drill includes a fluted distal portion and a distal drill tip. The drill flutes of the fluted distal portion taper from the distal drill tip to facilitate improved bone tip packing within the open volume defined by the drill flutes as the bone tip is created by the action of the introducer drill. According to some configurations, a robotic-enabled or robotically-controlled surgical system can be configured to introduce the introducer assembly through the skin adjacent to the vertebral body and into a pedicle connected to the vertebral body. According to some configurations, a robotic-enabled or robotically-controlled surgical system can be configured to position a surgical guide instrument such that the introducer assembly can be inserted through the surgical guide instrument, through the skin adjacent to the vertebral body, and into a pedicle connected to the vertebral body.

[0057] According to some implementations, inserting the introducer drill may not include hammering the introducer drill. In some implementations, inserting the introducer drill includes hammering the proximal handle of the introducer drill. The method may further include removing the introducer drill from the introducer cannula. The method may also include inserting a curved cannula assembly into a curved slot in the proximal handle of the introducer cannula. The curved cannula assembly may include a second cannula including a proximal handle with a curved insertion slot and a distal polymer tube, the distal polymer tube having a preformed curve but including a curved distal end configured to bend when placed under restraint. The curved cannula assembly may also include a second stylet including a proximal handle and a distal elongate shaft. The distal elongate shaft of the second stylet has a preformed curve but includes a curved distal end configured to bend when placed under restraint, and a distal channeling tip. The length of the curved distal end of the distal elongate shaft proximal to the distal channeling tip may include a cross-sectional circumferential profile that is shorter than the overall cross-sectional circumferential profile such that a greater gap exists between the outer cross-sectional dimension of the curved distal end of the distal elongate shaft and the inner diameter of the curved distal end of the second cannula along the length of the curved distal end of the distal elongate shaft proximal to the distal channeling tip. According to some configurations, a robotic-enabled or robotically-controlled surgical system can be configured to remove and insert the introducer drill and / or the curved cannula assembly.

[0058] In some implementations, the method further includes removing the second stylet from the second cannula. The method may also include inserting a third stylet into a slot in the proximal handle of the second cannula, beyond the open distal tip of the second cannula, where the third stylet is configured to form a linear path starting from the open distal tip of the second cannula toward the target treatment location (e.g., beyond a curved path formed by the curved cannula assembly), and removing the third stylet from the second cannula after the linear path is formed. The method may include inserting a treatment device into the slot in the proximal handle of the second cannula, beyond the open distal tip of the second cannula, to the target treatment location, and performing treatment at the target treatment location using the treatment device. The treatment may include ablating at least 75% of the branches of the basal nerve within the bone (e.g., a vertebral body). According to some configurations, a robotically enabled or robotically controlled surgical system can be configured to remove and insert the instruments described above.

[0059] Some embodiments of the present invention have one or more of the following advantages: (i) improved procedural precision, (ii) increased efficacy and improved safety, (iii) improved efficiency, (iv) improved accuracy, (v) synergistic results, (vi) a "one-and-done" procedure without the need for further surgical intervention, (vii) treatment of chronic back pain, (viii) pain prevention through early detection of factors that may cause future pain, (ix) ease of use (e.g., due to reduced friction or force), and / or (x) robotic control or guidance for easier access or navigation.

[0060] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features of embodiments of the present disclosure have been described herein. It should be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment of the disclosure provided herein. Thus, the embodiments disclosed herein may be embodied or performed to achieve or optimize one advantage or group of advantages as taught or suggested herein, without necessarily achieving other advantages as taught or suggested herein.

[0061] The methods summarized above and described in more detail below describe specific actions taken by a practitioner. However, it should be understood that they may also include the command of those actions by another party. Thus, an action such as "applying thermal energy" includes "commanding the application of thermal energy." Further aspects of embodiments of the present disclosure are described below in this specification. With respect to the drawings, elements from one figure may be combined with elements from other figures. [Brief explanation of the drawings]

[0062] Some embodiments of the present disclosure may be more fully understood by reference to the following drawings, which are for illustrative purposes only.

[0063] [Figure 1] 1 illustrates various vertebral levels and vertebrae that can be treated by the systems and methods described herein.

[0064] [Figure 2] 1 shows a human pelvis to illustrate potential methods of accessing specific vertebral bodies.

[0065] [Figure 3] 1 illustrates an exemplary kit or system of access tools configured to access vertebral bodies.

[0066] [Figure 3A] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3B] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3C] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3D] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3E] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3F] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3G] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3. [Figure 3H] 4 illustrates various steps of a method of accessing and treating tissue within a vertebral body using one or more of the access tools of the kit or system of FIG. 3.

[0067] [Figure 4] FIG. 1 shows a schematic block diagram of a robot-enabled system.

[0068] [Figure 5] 1 shows an example of a robotic-enabled system positioned in an operating room.

[0069] [Figure 5A] 1 shows a lateral view of a spine that can be displayed on the display of a robotic-enabled system.

[0070] [Figure 5B] FIG. 10 shows a posterior view of the spine that can be displayed on the display of a robotic-enabled system.

[0071] [Figure 5C] 1 shows an axial view of the spine that can be displayed on the display of a robotic-enabled system.

[0072] [Figure 6] FIG. 5 shows an example of a robot arm of a robot-enabled system.

[0073] [Figure 7] 7 shows an example of a surgical guide for the robotic arm of FIG. 6.

[0074] [Figure 8] 8 illustrates a surgical tool being inserted through the surgical guide of FIG. 7.

[0075] [Figure 9] 8 shows an example of an introducer cannula that can be inserted through the surgical guide of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0076] Some implementations described herein relate to systems and methods for modulating intraosseous or adjacent (e.g., peri) bone nerves using a robotic system. The robotic system may be integrated with a navigation system. The robotic system or a navigation system integrated with the robotic system may incorporate an augmented reality system and a device that incorporates real-time navigation images from intraoperative imaging (e.g., fluoroscopy or CT-guided imaging) into a 3D reconstructed model (e.g., a 3D model of a portion of the spine) within the surgeon's field of view. The 3D reconstructed model may be created from preoperative images (e.g., MRI or CT images) of a specific patient. Virtual reality systems and devices may be incorporated to facilitate the training of orthopedic surgeons in performing various spinal surgical or interventional procedures (e.g., spinal neuromodulation procedures such as ablation of intraosseous nerves within one or more vertebral bodies or ablation of nerves innervating one or more vertebral endplates and / or intervertebral discs). In some implementations, intraosseous nerves within spinal bones (e.g., vertebral bodies) (e.g., basal nerves or other nerves branching from the sinus vertebral nerves) are modulated for the treatment or prevention of chronic back pain. The nerve may be one or more nerves that innervate a vertebral endplate. The vertebral body may be located at any level of the spinal column (e.g., cervical, thoracic, lumbar, and / or sacral).

[0077] FIG. 1 schematically illustrates the spinal column and various vertebral segments or levels. Multiple vertebral bodies can be treated (simultaneously or sequentially) in a single visit or procedure. The multiple vertebral bodies can be located in a single spinal segment (e.g., two adjacent vertebral bodies in a sacral segment (e.g., S1 and S2) or lumbar segment (e.g., L3, L4, and / or L5) or thoracic or cervical segment) or in different spinal segments (e.g., the L5 vertebra in a lumbar segment and the S1 vertebra in a sacral segment). Intraosseous nerves within bones other than within vertebral bodies can also be modulated. For example, nerves within the humerus, radius, femur, tibia, calcaneus, tarsus, hip, knee, and / or phalanges can be modulated.

[0078] In some implementations, the nerve or nerves being adjusted are extraosseous nerves located outside the vertebral body or other bone (e.g., before the nerve enters the bone hole or after the nerve exits the bone hole). In addition to or instead of nerves, other tissues may be treated or otherwise affected (e.g., tumors or other cancerous tissue or fractures). Portions of nerves in or on one or more vertebral endplates or intervertebral discs between adjacent vertebral bodies may be adjusted.

[0079] Nerve or other tissue modulation may be performed to treat one or more indications, including, but not limited to, chronic lower back pain, upper back pain, acute back pain, joint pain, bone tumors, and / or fractures. Neural modulation may also be performed in conjunction with bone fixation or arthrodesis procedures to provide a synergistic or complete all-in-one "one-and-done" treatment that does not require additional surgical or minimally invasive intervention.

[0080] In some implementations, in addition to denervation treatment and / or tumor ablation, bone fractures can be treated by applying heat or energy and / or delivering drugs or bone filler materials to the bone. For example, bone morphogenetic proteins and / or bone cement can be delivered in conjunction with vertebroplasty or other procedures to treat fractures or promote bone growth or bone healing. In some implementations, energy is applied, and then drugs and / or bone filler materials are delivered in a combined procedure. In some embodiments, vertebral compression fractures (which may be caused by osteoporosis or cancer) are treated in conjunction with energy delivery to modulate nerves and / or cancerous tissue to treat back pain.

[0081] According to some implementations, the systems and methods (e.g., robotic systems and methods) for treating back pain or facilitating neuromodulation of intraosseous nerves described herein can be performed without surgical resection, without general anesthesia, without cooling (e.g., without cooling fluids), and / or substantially without blood loss. In various implementations, the systems and methods described herein are used to deliver non-implantable bone access tools and treatment devices. In some implementations, the systems and methods described herein allow for reduced radiation exposure and shortened procedure times. In some implementations, the systems and methods for treating back pain or facilitating neuromodulation of intraosseous nerves described herein facilitate easy retreatment if necessary. According to some implementations, successful treatments can be performed in difficult or hard-to-access locations, and access can be varied depending on bone structure (e.g., different bone densities) or different bone anatomies (e.g., different vertebral levels). One or more of these advantages also apply to treatments of tissues outside the spine (e.g., other orthopedic applications or other tissues).

[0082] Access to the vertebral body Access methods Various access methods may be used to access the vertebral body or other bone. In some implementations, the vertebral body is accessed transvertebrally (through one or both pedicles). In other implementations, the vertebral body is accessed extravertebrally (e.g., without crossing the pedicles). In some implementations, the vertebral body is accessed using an extreme lateral approach or a transforaminal approach, such as those used in XLIF and TLIF interbody fusion procedures. In some implementations, an anterior approach is used to access the vertebral body. Access may be assisted using a robotic system, such as the robotic system described in connection with Figures 4-9.

[0083] Certain vertebrae at the sacral or lumbar level (e.g., the S1 vertebra, the L5 vertebra) can also be accessed generally posterolaterally using a transiliac approach (e.g., an approach through the ilium). Referring to FIG. 2 , an access hole can be formed through the ilium at a location designed to facilitate access to a vertebral body or bodies in the sacrum or lumbar region. For example, an access tool (e.g., an introducer assembly including a cannula / stylet combination) can be delivered to the S1 vertebra via the ilium and / or sacroiliac joint or ala of the sacrum under image guidance (e.g., CT image guidance and / or fluoroscopy) and / or using a stereotactic or robotic-assisted surgical and / or navigation system, such as the robotic systems described in connection with FIGS. 4-9 . A treatment device can then be inserted through the introducer and / or other access cannula of the access tool to the target treatment location within the sacrum or lumbar spine. The transiliac approach may advantageously enhance a clinician's ability to access target treatment locations in certain portions or regions of the vertebral body (e.g., the posterior or posterior region) that cannot be adequately accessed using a translaminar approach. In some implementations, the vertebral body may be accessed directly through the dura to the posterior region of the vertebral body via the cerebrospinal fluid.

[0084] In some implementations, vertebral bodies can be accessed transforaminally through the basal vertebral foramen using stereotactic or robotic-assisted surgery and / or navigation systems, such as the robotic systems described in connection with Figures 4-9. Transforaminal access through the spinal canal can include the insertion of a "nerve finder" or nerve locator device and / or imaging / diagnostic tools to avoid spinal nerve damage during entry by the access tool or treatment device. The nerve locator device may comprise a handheld stimulation system, such as the Checkpoint Stimulator and Locator offered by Checkpoint Surgical® or the EZstim® peripheral nerve stimulator / nerve locator offered by Avanos Medical, Inc. The nerve finder or nerve locator device can advantageously identify sensitive nerves that should be avoided by the access tool to avoid risking paralysis or spinal cord injury when accessing the target treatment site. The nerve locator device can be configured to apply a stimulation signal between two points or locations and then evaluate the response to determine the presence of a nerve within the area between the two points or locations. The neural locator device may include a bipolar pair of stimulating electrodes or monopolar electrodes. In some implementations, the neural locator functionality may be implemented in the access tool or treatment device itself, as opposed to a separate, standalone device.

[0085] Access Tools and Treatment Devices The access tool (e.g., bone access tool) may include an introducer assembly including an outer cannula and a sharp stylet, an inner cannula configured to be introduced through the outer cannula, and / or one or more additional stylets, curettes, or drills to facilitate access to intraosseous locations within the vertebral body or other bone. The access tools (e.g., outer cannula, inner cannula, stylet, curette, drill) may have pre-curved distal ends or may be actively steerable or bendable. Any of the access tools may have a beveled tip or other sharp tip, or may have a blunt tip or a rounded, atraumatic distal tip. A curved drill may be used to facilitate the formation of a curved access path within the bone. In some implementations, any of the access tools may be advanced over a guidewire.

[0086] The access tools may be formed from a variety of flexible materials (e.g., ethylene vinyl acetate, polyethylene, polyethylene-based polyolefin elastomers, polyether ether ketone, polypropylene, polypropylene-based elastomers, styrene butadiene copolymers, thermoplastic polyester elastomers, thermoplastic polyurethane elastomers, thermoplastic vulcanizate polymers, metal alloy materials such as Nitinol, etc.). Combinations of two or more of these materials may also be used. The access tools may include chevron or other shaped designs or patterns or slits along their tips to enhance flexibility or bendability. Any of the access tools may be rotated manually or automatically (e.g., using a robotic control system such as those described in connection with Figures 4-9) to facilitate the desired trajectory.

[0087] In some implementations, the outer cannula assembly (e.g., introducer assembly) includes a straight outer cannula and a straight stylet configured to be received within the outer cannula. The outer cannula assembly may be initially inserted through an incision in the patient's skin to penetrate the outer cortical shell of the bone and provide a conduit for additional access tools to the inner cancellous bone. The inner cannula assembly may include a cannula with a pre-curved or steerable distal end and a stylet with a corresponding pre-curved or steerable distal end. Multiple stylets with distal ends having different curvatures may be provided in the kit and selected by the clinician. Alternatively, the inner cannula assembly may be configured to remain straight and uncurved.

[0088] 3 , in one implementation, an access tool kit or system includes an introducer assembly 110 comprised of an introducer cannula 112 and an introducer stylet 114, a curved cannula assembly 210 comprised of a curved cannula 212 and a J-stylet 214, and a straight stylet 314. The introducer stylet 114 may be beveled, trocar-tipped, and / or diamond-tipped. The introducer stylet 114 is configured to be received in the lumen of the introducer cannula 112 such that the distal tip of the introducer stylet 114 protrudes from the open distal tip of the introducer cannula 112, thereby combining to form the introducer assembly 110. The J-stylet 214 is configured to be received within the lumen of the curved cannula 212 such that the distal tip of the J-stylet 214 protrudes from the open distal tip of the curved cannula 212, thereby combining to form the curved cannula assembly 210. The curved cannula 212 and the J-stylet 214 may each include a straight proximal body portion and a curved distal end. The curvatures of the curved distal ends of the curved cannula 212 and the J-stylet 214 may correspond to one another. The straight stylet 314 is a flexible, channeling stylet configured to form and maintain a straight or nearly straight path as it is delivered through the curved cannula 212 and then exits the open distal tip of the curved cannula 212. Some of the tools are optional and may not be used in various implementations.

[0089] The access tool may be provided as a kit that may optionally further include one or more additional introducer cannulas, one or more additional introducer stylets (e.g., having different tips, such as one with a beveled tip and one with a diamond or trocar tip), one or more additional curved cannulas (e.g., having a curved distal end with a different curvature than the first curved cannula), additional J-stylets (e.g., having a different curvature or a different design configured to access bone), an introducer drill, and / or additional straight stylets (e.g., having a different length than the first straight stylet).

[0090] In some configurations, the access tool (e.g., kit) may be specially designed and adapted to facilitate access to hard, non-osteoporotic bone (e.g., bone within vertebral bodies such as the cervical, thoracic, lumbar, or sacrum). Hard bone may be determined based on bone mass density testing, compressive strength determination, compressive modulus determination, imaging modality, or based on tactile sensation by the surgeon as the access instrument is advanced. In some implementations, hard bone may be determined as bone having a bone density score within the standard deviation of that of a normal, healthy young adult (e.g., a T-score of -1 or greater). In some implementations, hard bone may be identified as bone having a compressive strength greater than 4 MPa and / or a compressive modulus greater than 80 MPa for cancellous bone, or a compressive modulus greater than 5.5 MPa and / or a compressive modulus greater than 170 MPa for cortical bone. Some kits may include at least two of all the access instruments. Some kits may include optional add-on components or accessory kit modules for accessing hard bone (e.g., an introducer drill 440 and a J-stylet 214 specially configured to access hard bone). Some kits may include any additional access tool components or accessory kit modules adapted to access one or more additional vertebrae in the same or different spinal segments. The kits may also include one or more (e.g., at least two) treatment devices (e.g., radiofrequency energy delivery probes). Each of the access tools may include one or more tracking devices or sensors (e.g., optical sensors, electromagnetic sensors, ultrasonic sensors, force sensors, motion sensors, proximity sensors) to facilitate alignment and tracking by the robotic system's navigation system, as further described herein.

[0091] 3A-3H illustrate example steps of a method of using an access tool to facilitate access to a location within a vertebral body 500 for a procedure (e.g., modulation of an intraosseous nerve such as the basal nerve, bone cement delivery for treatment of a vertebral fracture, and / or ablation of a bone tumor). One, some, or all of the method steps may be performed or facilitated by a robotic system, such as the robotic systems 700, 800 described and illustrated in connection with FIGS. 4-9. The robotic system may be configured to operate in a manual mode in which the surgeon applies forces (e.g., hammering or manually pushing, pulling, or rotating) to one or more surgical tools (e.g., an access tool, a treatment device, or a diagnostic device); a semi-automatic mode in which the surgeon controls one or more robotic arms via a joystick or handheld controller (e.g., in an augmented reality environment using an augmented reality system including a headset and one or more handheld joysticks or other input devices); and / or a fully automatic mode in which one or more robotic arms are automatically controlled upon execution of a computer program or algorithm. Input from the surgeon may also be received via voice commands using voice recognition software.

[0092] 3A, the distal portion of the introducer assembly 110 (including the distal tip 125 of the introducer stylet 114 and the distal tip of the introducer cannula 112) is inserted through the pedicle 502 adjacent to the vertebral body 500 after insertion and aligned engagement of the introducer stylet 114 within the introducer cannula 112. The introducer assembly 110 may be coupled to a robotic arm of a robotic system (e.g., systems 700, 800) or may be inserted through a guide placed by the robotic system.

[0093] According to some implementations, the method may optionally include removing the introducer stylet after initial penetration of the pedicle 502 (e.g., if the surgeon determines that the bone density is sufficiently dense or hard that additional steps and / or tools are required to obtain the desired curvilinear trajectory to access the posterior portion (e.g., posterior half) of the vertebral body 500). Referring to FIG. 3B , the method may optionally include inserting an introducer drill 440 into and through the introducer cannula 112 (e.g., via coupling to a robotic arm of a robotic system) to complete traversal of the pedicle 502 and penetration of the cortical bone region 503 of the vertebral body 500 until the cancellous bone region 504 of the vertebral body 500 is reached. The distal drill tip 448 of the introducer drill 440 may be advanced into the cancellous bone region 504 (particularly if the cancellous bone region 504 is determined to be sufficiently hard or dense), or advancement may be stopped at the boundary between the cortical bone region 503 and the cancellous bone region 504. This step may include both rotating the introducer drill 440 and advancing the introducer drill 440, or simply rotating the introducer drill 440. Referring to FIG. 3C , the introducer drill 440 may be removed and the introducer stylet 114 may be reinserted into the introducer cannula 112. 3D , the introducer assembly 110 (e.g., via coupling to a robotic arm of a robotic system) may then be advanced to advance the distal tip 122 of the introducer cannula 112 to an entry site in (or within) the cancellous bone region 504 of the vertebral body 500. The introducer stylet 114 may then be removed from the introducer cannula 112.

[0094] The curved cannula assembly 210 may then be inserted into the introducer cannula 112. With reference to FIG. 3E, the collective distal ends of the curved cannula assembly 210 may be advanced together (e.g., in an automated manner via coupling to a robotic arm of a robotic system, or by manual hammering on the proximal handle of the J-stylet 214) from the distal tip of the introducer cannula 112 along a curved path within the cancellous bone region 504. The curved distal end of the J-stylet 214 is configured to remain within the curved cannula 212 at all times during operation, such that the distal channeling tip 218, or only a portion of the distal channeling tip 218, extends from the curved distal end 225 of the curved cannula 212. With reference to FIG. 3F, the J-stylet 214 may then be removed from the curved cannula 212 while maintaining the curved cannula 212 in place. According to some implementations, the path formed by conventional instruments may advantageously allow the curved cannula assembly 210 to have a head start and begin to curve as soon as it exits the open distal tip of the introducer cannula 112.

[0095] 3G , if a further straight path beyond the curved path is desired to reach the target treatment location, a straight stylet 314 may be inserted through the curved cannula 212 (e.g., via coupling to a robotic arm of a robotic system) such that the distal channeling tip 318 of the straight stylet 314 extends beyond the open distal tip of the curved cannula 212 along a straight path toward the target treatment location (e.g., the basal nerve trunk or vertebral basilar foramen). In some implementations, the straight stylet 314 may not be needed, and this step may be skipped.

[0096] 3H , a treatment device 501 (e.g., a flexible bipolar radiofrequency probe) may be inserted through the curved cannula 212 (e.g., via coupling to a robotic arm of a robotic system) (after removing the straight stylet 314, if used) and advanced from the open distal tip of the curved cannula 212 to the target treatment location. The treatment device 501 may then perform the desired treatment. For example, if the treatment device 501 is a radiofrequency probe, the treatment device 501 may be actuated to ablate an intraosseous nerve (e.g., the basilar nerve) or a tumor inside the vertebral body 500. After the treatment device 501 is removed from the curved cannula 212, bone cement or other agents, or a diagnostic device (such as a nerve stimulator or imaging device to confirm nerve ablation) may optionally be delivered through the curved cannula 212.

[0097] At certain levels of the spine (e.g., sacral and lumbar levels) and for certain patient spinal anatomy requiring a steeper curvature to access the desired target treatment location within the vertebral body, a curette / curved introducer combination may be inserted first (e.g., via coupling to a robotic arm of a robotic system) to begin a curvature trajectory (e.g., forming an initial curve or shelf) into the vertebra. The curette may have a pre-curved distal end or may be configured so that the distal end can be controllably articulated or curved (e.g., manually via a pull wire, by rotating a handle member coupled to one or more pull wires coupled to the distal end, or automatically by a robotic or artificial intelligence-driven navigation system). The curette / curved introducer combination may then be removed, and an outer straight cannula and inner curved cannula / curved stylet assembly may then be inserted to continue the curvature toward the target treatment location.

[0098] According to some implementations, either the access tool (e.g., a cannula or stylet) or the treatment device may include a rheological and / or magnetizable material (e.g., a magnetorheological fluid) along the distal end of the access tool configured to bend in situ after insertion into a desired location within bone (e.g., a vertebra). A magnetic field is applied to the distal end of the access tool and / or treatment device using the magnetizable fluid or other material and may be adjusted or varied using one or more permanent magnets or electromagnets to bend the distal end of the access tool and / or treatment device toward the magnetic field. In some implementations, the treatment probe may include a magnetic wire along a portion of its length (e.g., the distal end). A voltage applied to the magnetic wire may be increased or decreased to increase or decrease the curvature of the magnetic wire. These implementations may advantageously facilitate controlled steering without manual pull wires or other mechanical mechanisms. The voltage may be applied by an instrument controlled and operated by an automated robotic control system, such as the robotic systems described in connection with Figures 4-9.

[0099] The treatment device (e.g., treatment probe) may be any device capable of modulating tissue (e.g., nerve, tumor, bone tissue). Any energy delivery device capable of delivering energy may be used (e.g., RF energy delivery device, microwave energy delivery device, laser device, infrared energy device, other electromagnetic energy delivery device, ultrasound energy delivery device, etc.). The treatment device 501 may be an RF energy delivery device. The RF energy delivery device may include a bipolar electrode pair at the distal end of the device. The bipolar electrode pair may include an active tip electrode and a return ring electrode spaced apart from the active tip electrode. The RF energy delivery device may include one or more temperature sensors (e.g., thermocouples, thermistors) disposed on the exterior surface of or embedded within the shaft of the energy delivery device. According to some implementations, the RF energy delivery device may not use internal circulatory cooling.

[0100] According to some implementations, thermal energy can be applied within the cancellous bone portion of the vertebral body (e.g., by one or more radio frequency (RF) energy delivery instruments coupled to one or more RF generators). The thermal energy can be conducted by heat transfer to the surrounding cancellous bone, thereby heating the cancellous bone portion. According to some implementations, the thermal energy is applied within a specific frequency range and with a sufficient temperature and duration to heat the cancellous bone such that the basal nerves extending through the cancellous bone of the vertebral body are modulated. In some implementations, the modulation includes permanent ablation or denervation or cell perforation (e.g., electroporation). In some implementations, the modulation includes temporary denervation or inhibition. In some implementations, the modulation includes stimulation or denervation without tissue necrosis.

[0101] In the case of thermal energy, the temperature of the thermal energy can be in the range of about 70 to about 115°C (e.g., about 70 to about 90°C, about 75 to about 90°C, about 83 to about 87°C, about 80 to about 100°C, about 85 to about 95°C, about 90 to about 110°C, about 95 to about 115°C, or overlapping ranges thereof). The temperature gradient can be in the range of 0.1 to 5°C / sec (e.g., 0.1 to 1.0°C / sec, 0.25 to 2.5°C / sec, 0.5 to 2.0°C / sec, 1.0 to 3.0°C / sec, 1.5 to 4.0°C / sec, 2.0 to 5.0°C / sec). Treatment times can range from about 10 seconds to about 1 hour (e.g., 10 seconds to 1 minute, 1 minute to 5 minutes, 5 minutes to 10 minutes, 5 minutes to 20 minutes, 8 minutes to 15 minutes, 10 minutes to 20 minutes, 15 minutes to 30 minutes, 20 minutes to 40 minutes, 30 minutes to 1 hour, 45 minutes to 1 hour, or overlapping ranges thereof). Pulsed energy can be delivered as an alternative to or sequentially with continuous energy. For radiofrequency energy, the applied energy can range from 350 kHz to 650 kHz (e.g., 400 kHz to 600 kHz, 350 kHz to 500 kHz, 450 kHz to 550 kHz, 500 kHz to 650 kHz, overlapping ranges thereof, or any value within a recited range, such as 450 kHz ± 5 kHz, 475 kHz ± 5 kHz, 487 kHz ± 5 kHz, etc.). The radiofrequency energy output can range from 5 W to 30 W (e.g., 5 W to 15 W, 5 W to 20 W, 8 W to 12 W, 10 W to 25 W, 15 W to 25 W, 20 W to 30 W, 8 W to 24 W, and overlapping ranges thereof, or any value within the listed range). According to some implementations, the thermal treatment dose (e.g., using a cumulative equivalent minute (CEM) 43°C thermal dose calculation metric model) is 200 to 300 CEM (e.g., 200 to 240 CEM, 230 CEM to 260 CEM, 240 CEM to 280 CEM, 235 CEM to 245 CEM, 260 CEM to 300 CEM) or greater than a predetermined threshold (e.g., greater than 240 CEM). The CEM number can represent the average thermal cumulative dose value at the target treatment region or location, or a number representing the desired dose for a particular biological endpoint. Alternatively, an Arrhenius model may be used to estimate and quantify the desired thermal dose.Thermal damage can occur via necrosis or apoptosis.

[0102] Cooling may optionally be provided to prevent heating of surrounding tissue during neuromodulation procedures. Cooling fluid may be circulated internally through the delivery device from and to a fluid reservoir in a closed-circuit manner (e.g., using inflow and outflow lumens). The cooling fluid may include pure water or saline solution having a temperature sufficient to cool the electrodes (e.g., 2-10°C, 5-10°C, 5-15°C). Cooling may be provided by the same device used to deliver thermal energy (e.g., heat) or by a separate device. According to some implementations, no cooling is used.

[0103] In some implementations, ablative cooling can be applied to nerve or bone tissue instead of heat (e.g., for cryoneurolysis or cryoablation applications). The temperature and duration of cooling can be sufficient to modulate intraosseous nerves (e.g., ablation or localized freezing due to excessive cooling). Low temperature can disrupt the myelin capsule or sheath surrounding the nerve. Low temperature can also advantageously reduce the sensation of pain. Cooling can be delivered using a hollow needle under fluoroscopy or other imaging modalities.

[0104] In some implementations, one or more fluids or agents may be delivered to the target treatment site to modulate the nerve. The agent may include, for example, a bone morphogenetic protein. In some implementations, the fluid or agent may include a chemical agent (e.g., a chemical disruptant, alcohol, phenol, a nerve inhibitor, or a nerve stimulant) for modulating the nerve. The fluid or agent may be delivered using a hollow needle or injection device under fluoroscopy or other imaging modality.

[0105] One or more treatment devices (e.g., probes) can be used simultaneously or sequentially. For example, the distal ends of two treatment devices can be inserted into different locations within a vertebral body or other bone, or within different vertebral bodies or bones. Radiofrequency treatment probes can include multiple electrodes configured to act as monopolar or unipolar electrodes or as a pair of bipolar electrodes. Treatment devices can also be pre-curved or bendable so that a curved stylet is not required, or they can have a sharp distal tip so that an additional sharp stylet is not required. In some implementations, any or all of the access tool and treatment device are MR compatible so that they can be visualized under MR imaging.

[0106] One or more treatment devices (e.g., a probe, such as a radiofrequency probe, or treatment device 501 of a kit or system) may include an indicator configured to alert a clinician about the current operating state of the treatment device. For example, the indicator may include a light ring disposed along the length of the treatment device and extending around the treatment device. The light ring may be configured to illuminate in different colors and / or indicate other visual effects (e.g., pulsing on / off in a particular pattern). One or more treatment devices may also be configured to provide audible alerts (e.g., beeps with a particular frequency or intonation) corresponding to different operating states. In one implementation, the light ring may be dim or unlit when the treatment device is not connected to a radiofrequency generator or is not ready for RF energy delivery. The light ring may pulse at a first rate (e.g., one pulse every 2-3 seconds) to indicate an operating state in which the treatment device and generator system are ready to begin RF energy delivery. The light ring may be continuously illuminated to indicate an operating state in which the treatment device is actively delivering RF energy. The light ring may pulse at a second rate different from the first rate (e.g., faster, slower) to indicate an operating condition in which an error is detected by the generator or if a particular treatment parameter is determined to be outside of a range of acceptable values. In one implementation, the second rate is greater than the first rate (e.g., 2 pulses per second). Haptic feedback may be provided to the clinician for at least some of the operating conditions to provide further warning in addition to the visual warning.

[0107] In some implementations, the treatment device (e.g., treatment device 501) includes a microchip pre-programmed with treatment parameters (e.g., treatment duration, target temperature, temperature gradient rate). When the treatment device is electrically connected to the generator, the treatment parameters are transmitted to the generator and displayed on the generator's display, providing the clinician confirmation of the desired treatment.

[0108] Extravertebral access To access locations outside the bone (e.g., extraskeletal locations, such as outside the vertebral body), visualization or imaging modalities and techniques can be used to facilitate targeting. For example, the vertebral foramen (e.g., basilar foramen) of a vertebral body can be located using MRI guidance provided by an external MR imaging system, CT guidance provided by an external tomographic imaging system, fluoroscopic guidance using an external X-ray imaging system, and / or a laparoscopically inserted endoscope. Once the foramen is located, a therapy (e.g., heat or energy delivery, chemical ablative agent delivery, cryotherapy, brachytherapy, and / or mechanical cutting) sufficient to modulate (e.g., ablate, denervate, stimulate) any nerves entering through the foramen can be applied to the foramen. For example, an endoscope can be used to directly visualize the foramen, and then the basilar nerve can be mechanically cut near the foramen. In some implementations, the intervertebral disc and vertebral body can be denervated by treating (e.g., ablating) the sinovertebral nerve before it branches into the basilar nerve that enters the basal foramen of the vertebral body.

[0109] Robotic-assisted access and / or procedures Access and / or treatment within bone or adjacent bone (e.g., vertebral bodies) can be facilitated by the use of a robotic navigation system or robotic control device (e.g., a computerized or computer-assisted system or device). For example, a robot can be used to facilitate or assist positioning, targeting, deployment (e.g., hammering or malleting), avoid over-insertion that could cause injury or damage, and / or facilitate nerve sensing. FIG. 4 schematically illustrates an example of a robot-enabled system 700. The robotic system 700 can be a robotic control, surgical, and / or navigation system capable of performing various medical and / or diagnostic procedures and / or providing guidance and enhanced imaging to clinicians. The robotic system 700 can be a robotic-assisted spine surgery system or a spinal robotic system.

[0110] The robotic system 700 may include an operator workstation or control console 702 from which a clinician can control the movement of one or more robotic arms 703 to provide improved ease of use and precise control of movement. The workstation or control console 702 may include a computer-based control system configured to store and execute (e.g., using one or more processors) program instructions stored on a non-transitory computer-readable storage medium (e.g., a solid-state storage drive, a magnetic storage drive, other memory).

[0111] The robotic arm 703 may be configured to move with six or more degrees of freedom and to support or carry access tools, treatment devices, and / or diagnostic devices. The robotic arm 703 may include multiple separate arm sections connected to each other at joints or pivot points to facilitate movement with six or more degrees of freedom along various axes of rotation. The robotic arm 703 may comprise multiple separate arms, each separately controllable and each configured to hold and manipulate a different surgical instrument (e.g., access tool or treatment device). The robotic arm 703 may be controlled by one or more instrument drive systems coupled to the support system and controlled by the control console 702. The instrument drive systems may include electromechanical components and mechanisms (e.g., drive motors, gears, pulleys, joints, hydraulics, wires, etc.) configured to actuate and move the robotic arm 703.

[0112] The robotic system 700 may also include one or more imaging devices 704 (such as a camera, endoscope, laparoscope, ultrasound imaging modality, fluoroscopic imaging modality, CT imaging modality, MR imaging modality, etc.). The imaging device 704 may be supported or carried by one or more of the robotic arms 703. The imaging device 704 may be a component of an imaging system that facilitates 360-degree scanning of the patient. The imaging device 704 may include a stereotactic camera, an optical sensor, and / or an electromagnetic field sensor. In some implementations, the imaging device 704 of the robotic system 700 reduces the patient's exposure to radiation. The imaging device 704 may be calibrated to the patient's anatomy or using reference pins or tracking devices placed at one or more locations on the patient's body by an alignment or localization system. The alignment system may include multiple computing devices (e.g., a processor and a computer-readable memory for storing instructions executed by the processor). Alignment may include identifying natural landmarks of one or more vertebrae (e.g., using a pointer device of the alignment system).

[0113] The imaging system may be configured to communicate with software (e.g., running on the surgeon workstation or control console 702 or registration system) configured to generate a real-time 3D map that can be registered to the robotic arm 703 or instruments supported by the robotic arm 703. The software may include surgical planning software configured to plan a desired trajectory for accessing a target treatment location within a vertebral body or other bone based on 2D, 3D, or 4D preoperative images (e.g., obtained via CT, MRI, fluoroscopy, or other imaging modalities). However, in some implementations, preoperative planning is not used and navigation may be performed intraoperatively. The software may include navigation software configured to control the robotic arm 703 and provide feedback regarding navigation (e.g., trajectory and positioning information) to the surgeon on the surgeon workstation or a separate display device (e.g., a display on an augmented reality headset or eyewear or tablet). The computing device of the control console 702 is configured to direct the movement of the robotic arm 703 based on instructions executed by the computing device (via input from a clinician (e.g., manual joystick control or voice-activated commands) or via automated programs and artificial intelligence algorithms stored in memory). The computing device includes one or more dedicated processors. The robotic system 700 can be used to perform any of the access, diagnostic, or treatment methods described herein while providing controlled movements to reduce the likelihood of injury caused by manual operator error or misjudgment.

[0114] In some implementations, the robotic system 700 includes a closed-loop system that modifies the trajectory of an access tool or treatment device based on feedback. Feedback may include feedback based on the use of neural network-based artificial intelligence or deep learning models trained using supervised or unsupervised training techniques that include a large database of pre- and post-operative patient images undergoing a particular neuromodulation procedure. The images may include images of patients with different bone structures (e.g., bone density), bone anatomy, and vertebral bodies with degradation or defects (e.g., pre-modulation characteristics such as degeneration or defects of vertebral endplates or diagnosed Modic changes). Feedback may be based only on images of the specific level of the vertebral body being treated, images of vertebral bodies with similar densities to the vertebral body being treated, or images of vertebral bodies from patients with similar patient characteristics (e.g., age, lifestyle, gender, pain score). Neuromodulation (e.g., optimal neuromodulation parameters) may also be robotically implemented based on intelligent (e.g., artificial intelligence) feedback. The robotic system 700 may include a machine-driven navigation system that deploys an energy source toward a target within the vertebral body being treated. Detection and monitoring of the energy source's proximity to the target may be provided by one or more imaging devices. The robotic system 700 can independently change trajectory and / or neuromodulation parameters in response to imaging or other alignment modalities. Trajectory changes can be due to changes in the configuration of the drive system (e.g., robotic arm 703) and / or due to changes in the configuration of the energy delivery device or assembly. Trajectory changes can be automatic (e.g., closed loop) or based on a feedback mechanism to the surgeon (e.g., open loop). Open loop modes may or may not include boundary conditions (e.g., haptic conditions). Detection and monitoring functions can rely on pre-operative and / or intra-operative data. Alignment and targeting can be proactive or interactive.

[0115] 5 illustrates another exemplary robotic-enabled system 800 that can be used to facilitate or assist in the positioning, targeting, and / or deployment (e.g., hammering) of one or more of the access or surgical tools described above. In certain applications, the robotic-enabled system 800 can provide a guide to the surgeon to help accurately perform one or more methods for modulating nerves within a bone or adjacent (e.g., surrounding) bone, such as intraosseous nerves within a bone (e.g., basal nerves or other nerves within a vertebral body, or nerves innervating a vertebral endplate). For example, the robotic-enabled system 800 can provide robotic guidance of a surgical tool (e.g., one or more of the surgical tools, bone access tools, or treatment devices described herein) to ensure proper trajectory of the tool (e.g., introducer assembly 110, curved cannula assembly 210, introducer drill 440, and / or treatment device 501).

[0116] 5, the robotic system 800 may include an operator workstation or control console 801 from which a clinician can control the movement of the tool holder to provide improved ease of use and precise control of movement. The workstation or control console 801 may include a computer-based control system configured to store and execute (e.g., using one or more processors) program instructions stored on a non-transitory computer-readable storage medium (e.g., a solid-state storage drive, a magnetic storage drive, other memory). The control console 801 may include various instruments for a user to provide input to the control system, such as a joystick or other handheld controller and / or a keyboard, as shown in FIG. 5.

[0117] In certain implementations, the surgical robotic system 800 includes a surgical robot 802 on a mobile cart 814. The surgical robot 802 can be positioned near the operating table 812 without being attached to the operating table 812. In the configuration shown, the control console 801 is also on the mobile cart 814. In certain implementations, the control console 801 and the mobile cart 814 can be separate units and / or the surgical robot 802 can be fixed. For example, in certain configurations, the surgical robot 802 can be fixable to or formed as part of the operating table 812. For example, in certain implementations, the surgical robot 802 can be positioned on a rail system (not shown) positioned on and / or above the operating table 812.

[0118] The mobile cart 814 may allow a user (operator) to move the surgical robot 802 to different locations before, during, and / or after a surgical procedure and / or may allow the surgical robot 802 to move in and out of the operating room 803. The mobile cart 814 may include wheels and / or may be positioned on a track system. The mobile cart 814 may also include a handle 805 so that the mobile cart 814 can be moved by the user. In certain implementations, the cart 814 can be motorized, and the position of the cart 814 can be remotely controlled by the user.

[0119] The cart 814 may include a stabilization system that can be used to increase the rigidity of the cart 814 to aid in the precision of the surgical procedure. For example, in certain implementations, the wheels may include a locking or braking mechanism that prevents the cart 814 from moving after being placed in a locked or braked configuration. In certain configurations, the stabilization, braking, and / or locking mechanism may be activated when the surgical robot 802 is turned on. The stabilization, braking, and / or locking mechanism may be activated and deactivated entirely mechanically and / or electronically, and / or may be activated and deactivated manually and / or automatically.

[0120] As shown in FIG. 5 , the surgical robot 802 can include a robotic arm 803 mounted on a mobile cart 814. The robotic arm 803 can be configured to move with one or more degrees of freedom (e.g., four degrees of freedom with two translations and two rotations, or six degrees of freedom with three translations and three rotations) and to support or carry an end effector or tool holder 809 that holds a surgical tool 806, which can be a surgical guide 806, as described below. The arm 803 can include multiple arm sections connected with pivot joints to facilitate movement around multiple degrees of freedom or rotations. The arm 803 can include electromechanical components and mechanisms (e.g., motors, gears, pulleys, joints, hydraulics, wires, etc.) configured to actuate and move the robotic arm 803.

[0121] In certain configurations, the end effector 809 of the robotic arm 803 is configured to releasably hold a surgical tool 806 (e.g., an access tool, a treatment device, a diagnostic device, a surgical guide), allowing the surgical tool 806 to be removed and replaced with a second surgical tool. The system 800 may allow the surgical tool (e.g., an access tool or a treatment device described herein) to be replaced without realignment of the position of the end effector 809 or with automatic or semi-automatic realignment.

[0122] As shown in the illustrated example of FIG. 5 , the system 800 can include a tracking system 808 that can be used to capture the positions of different components of the patient and surgical robot 802, and a display screen 810 that displays, for example, real-time patient data and / or real-time surgical robot trajectory. The tracking system 808 can be used to monitor the position of the patient and surgical robot 802. The tracking system 808 can include one or more cameras, video cameras, infrared detectors, localizers, field generators, and / or sensors for electromagnetically and / or optically tracking the robot 802 and / or the patient. The display screen 810 can also be coupled to the cart 814, and / or multiple display screens can be provided. In certain implementations, the display screen 810 can be incorporated into or replicated in one or more headsets worn by the user. In certain implementations, the headset with the display screen (e.g., a head-up display) can be an augmented reality headset, eyewear, or virtual reality headset, and the system 800 is configured for the surgeon to operate in an augmented reality or virtual reality environment. The display screen 810 may also include a see-through display on a tablet or portal configured to be positioned directly above the surgical access location.

[0123] In certain configurations, the robotic system 800 can be used with an augmented reality device 820 (such as, but not limited to, Google Glass, Microsoft's HoloLens headset, or Osterhout Design Group's augmented reality smart glasses and virtual reality headsets) to display the optimal position of surgical instruments positioned by the robotic system 800. In certain configurations, the glasses or headset can include an optical head-mounted display. An optical head-mounted display (OHMD) can be a wearable display capable of reflecting projected images and allowing a user to see through it. The augmented reality device 820 may alternatively comprise a tablet or portal that can be coupled to the arm of the robotic system 800 or to the patient's operating table or stand, allowing the tablet or portal to be positioned directly above the target treatment site.

[0124] A silhouette of the tool (e.g., a surgical tool such as an access tool or treatment device) and / or target site in an optimal position may be shown within the field of view of the augmented reality device 820. Positioning indicators may also be shown within the field of view to guide or direct positioning. The augmented reality device 820 may collect information from internal sensors (e.g., optical, electromagnetic, ultrasonic, force, motion, proximity) within the robotic system 800 and / or tracking system 808. In certain configurations, the robotic system 800 may include a head-mounted display configured to operate in both tracked and non-tracked modes, provide an optical view of the patient, and include an internal tracking device configured to inject or project received data content on top of the optical view to form an augmented reality view of the patient and determine the position of surgical instruments positioned by the robotic system 800 relative to the patient and the target anatomy and / or treatment site.

[0125] The augmented reality device 820 may include a see-through display configured to display a virtual image overlaid or superimposed on the real-time field of view of the surgical tools and the patient, thereby eliminating the need for the orthopedic surgeon to turn their head to view one or more displays or written treatment instructions outside the treatment field. The virtual image may provide surgical or treatment guidance overlaid or superimposed on the optical field of view. The virtual image may include a real-time video or imaging feed (e.g., fluoroscopy or computed tomography image guidance) of the target treatment site (such as a vertebral body), a planned virtual trajectory or path displayed as indicators, icons, lines, arrows, or other images, pre-operative 2D, 3D, or 4D anatomical images (e.g., magnetic resonance images or computed tomography images), and / or alphanumeric content (e.g., treatment instructions, cautions, alarms, warnings, real-time or previously acquired characteristics (e.g., heart rate, bone density measurements, vertebral body level indicators or labels (e.g., L4, L5, S1), and / or real-time treatment parameters (e.g., impedance measurements, treatment duration timer, temperature measurements, power output measurements), etc.). In some implementations, intraoperative 3D imaging technology is not used.

[0126] The surgeon may also input text or annotations into the display of the augmented reality device 820 using voice-activated commands, via a virtual touchscreen keyboard on the display, or via one or more input devices (e.g., joysticks) wirelessly coupled to the augmented reality device 820. The entered text or annotations may be reproduced on other displays in the hospital operating room, outpatient operating room, or outpatient procedure room for others to view. The entered text or annotations may be recorded and stored with intraoperative video or still images (e.g., for documentation or follow-up purposes). The augmented reality device 820 may also enable the surgeon to perform procedures from a remote location via a communications network. The augmented reality device may be communicatively coupled to the robotic system 800, allowing the surgeon to control the operation of the robotic system 800 in person or remotely.

[0127] The robotic system 800 may further include an augmented reality computing system (not shown) comprising one or more processors, one or more computer-readable tangible storage devices, and program instructions stored in at least one of the one or more storage devices for execution by at least one of the one or more processors. In certain configurations, a stereoscopic augmented view of the patient from a static or dynamic viewpoint of the surgeon or other clinician can be provided, using real-time three-dimensional surface reconstruction for pre- and intra-operative image registration. In such configurations, a stereoscopic camera can provide real-time images of the scene including the patient. A stereoscopic video display or displays on the augmented reality device 820 can be used by the surgeon to view a graphical representation of the pre- or intra-operative images stereoscopically blended with the video image through a see-through display. While the above controller and display embodiments are described in the context of an augmented reality application, the teachings disclosed herein can be used in connection with other digital reality applications, such as virtual reality and mixed reality. Therefore, the description of augmented reality is for illustrative purposes only, and does not limit the present disclosure to augmented reality applications.

[0128] For example, the robotic system 800 may be integrated with a virtual reality system to facilitate training of surgeons or other clinicians in performing neuromodulation procedures (e.g., intraosseous nerve ablation procedures described herein) using the access tools and treatment devices described herein. The virtual reality system for providing the virtual reality environment may include a processor (e.g., a processor configured to implement computer-executable instructions stored in a memory) for generating the virtual reality environment (e.g., minimally invasive spinal neuromodulation, such as basal nerve ablation, virtual reality environment, etc.). The virtual reality system may also include a head-mounted display (e.g., in a headset or goggles) wearable by the surgeon and one or more handheld controllers (e.g., joysticks) that can be manipulated by the surgeon to interact with the virtual environment provided by the virtual reality system.

[0129] In some implementations, the head-mounted display includes an immersive virtual reality display that displays the virtual environment to the surgeon (e.g., from a first-person perspective of the virtual environment). The virtual reality system may additionally or alternatively include one or more external displays for displaying the virtual environment to others in addition to the surgeon (e.g., for training or evaluation purposes). The immersive display and the one or more external displays may be duplicated or synchronized with each other to show the same content. According to some configurations, the virtual reality system may be configured to generate a virtual environment in which a surgeon (e.g., a surgeon or other clinician) can navigate around a virtual operating room (e.g., in an outpatient operating room or ambulatory surgery center) and interact with a virtual patient and surgical tools (e.g., bone access instruments, diagnostic tools, treatment devices typically used in spinal neuromodulation procedures) via the head-mounted display and / or handheld controllers.

[0130] The virtual reality system may be used to prepare to perform a spinal neuromodulation procedure (e.g., a basal nerve ablation procedure) using a robotic system, including, but not limited to, training, simulation, and / or collaboration between multiple surgeons, students, researchers, or other clinicians.

[0131] In some implementations, the virtual reality system may interface with an actual, real-world operating room. In some implementations, the virtual reality system may include one or more computer processors configured to provide visualization of the robotic spine neuromodulation environment (via a head-mounted display) and generate the virtual robotic spine neuromodulation environment, including at least one virtual robotic arm or robotic manipulator and at least one sensor or tracking device (e.g., optical sensor, electromagnetic sensor, ultrasonic sensor, force sensor, motion sensor, proximity sensor). The sensor or tracking device may be communicatively coupled to the one or more computer processors and configured to detect a state of a real robotic arm or robotic manipulator corresponding to the virtual robotic arm or robotic manipulator. The one or more processors may be configured to receive the detected state of the robotic arm or robotic manipulator and modify the virtual robotic arm or robotic manipulator based on the detected state, such that the virtual robotic arm or robotic manipulator copies or mimics the real robotic arm or robotic manipulator.

[0132] As an example, a trainer or observer (e.g., a student or peer clinician) may monitor an actual robotic spinal neuromodulation procedure in an actual operating room via a virtual reality system that interfaces with the actual operating room (e.g., the trainer or observer may interact with a virtual reality environment that reflects actual operating room conditions).

[0133] Continuing with reference to FIG. 5 , the robotic system 800 may also include one or more imaging devices 824 (such as a camera, endoscope, laparoscope, ultrasound imaging modality, fluoroscopic imaging modality, MR imaging modality, etc.). The imaging device 804 may be supported or carried by the robot 802. The imaging device 824 may be a component of an imaging system that facilitates 360-degree scanning of the patient. The imaging device 824 may include a stereotactic camera and / or an electromagnetic field sensor. The imaging device 824 may be calibrated to the patient's anatomy or using reference pins or tracking devices placed at one or more locations on the patient's body by an alignment or localization system. The alignment system may include multiple computing devices (e.g., a processor and a computer-readable memory for storing instructions executed by the processor). Alignment may include identifying natural landmarks of one or more vertebrae (e.g., spinous process, superior articular process, transverse process, pedicle, infralaminar foramen) (e.g., using a pointer device of the alignment system). Tracking devices and / or tactile sensors may be attached to external skin locations corresponding to the location of one or more spinous processes of the vertebrae to help determine the shape and / or position of the one or more spinous processes, which shape or position can then be fitted to a three-dimensional model of the spine (or portion of the spine) for alignment purposes.

[0134] In certain implementations, the display screen 810 can be used to display a projected or virtual trajectory and / or a proposed trajectory of a tool being inserted through the tool holder 806, the virtual trajectory forming a virtual axis. By continuously monitoring the position of the patient and robotic arm using tracking detectors 808 and / or internal sensors (e.g., optical encoders and / or other position sensors) located within the surgical robot 802, the surgical system can calculate updated trajectories and visually display these trajectories on the display screen 810 to inform and guide an operator (e.g., a surgeon and / or technician) in the operating room using the surgical robot. Furthermore, in certain implementations, the surgical robot 802 can also change its position and position automatically based on a trajectory calculated from the robotic arm position captured using the real-time patient and tracking detectors 808. For example, the trajectory of the end effector can be automatically adjusted in real time to account for movement of the vertebrae and / or other parts of the patient 104 and / or movement of the arm 803 during the surgical procedure.

[0135] As described above, the imaging device 824 may be calibrated to the patient's anatomy or using reference pins or tracking devices placed at one or more locations on the patient's body by a registration or localization system. The registration system may include multiple computing devices (e.g., a processor and computer-readable memory for storing instructions executed by the processor). Registration may include identifying natural landmarks of one or more vertebrae (e.g., spinous processes, superior articular processes, transverse processes, pedicles, infralaminal foramina) (e.g., using a pointer device or registration system). The imaging system may be configured to communicate with software (e.g., running on a surgeon workstation or control console or registration system) configured to generate a real-time 3D map that can be registered to the robotic arm 803 or an instrument supported by the robotic arm 803. The software may include surgical planning software configured to plan a desired trajectory for accessing a target treatment location within a vertebral body or other bone based on preoperative images (e.g., obtained via CT, MRI, fluoroscopy, or other imaging modality). The desired trajectory or path may be suggested by the surgical planning software. However, in some implementations, preoperative planning may not be used and navigation may be performed intraoperatively.

[0136] The desired trajectory may be generated automatically through automated surgical planning, generated using machine learning algorithms including trained neural networks, or determined by the surgeon or other clinical expert. The desired trajectory may be based on one or more factors or parameters, such as the bone density of the target vertebra, whether the access is performed transvertebrally or extravertebrally, the vertebral level (e.g., sacral, lumbar, thoracic, cervical, S1, S2, S3, S4, L1, L2, L3, L4, L5, etc.), the location of the vertebral foramen, the preset curvature of the access instrument, whether the access is performed using straight instruments, pre-curved instruments, or steerable instruments, and / or other factors or parameters. The desired trajectory may also be based on pre- or intraoperative patient images and / or the surgeon's past experience. The software may include navigation software configured to control the robotic arm 803 and provide navigation feedback (e.g., trajectory and positioning information) to the surgeon at the surgeon workstation or a separate display device. The computing device of the control console is configured to direct the movement of the robotic arm 803 based on instructions executed by the computing device (via input from a clinician (e.g., a joystick control) or via automated programs and artificial intelligence algorithms stored in memory). The computing device includes one or more dedicated processors. The robotic system 800 can be used to perform any of the access, diagnostic, or treatment methods described herein while providing controlled movements to reduce the likelihood of injury caused by manual operator error or poor judgment. In some implementations, the robotic system 800 includes a closed-loop system that alters the trajectory of an access tool or treatment device based on feedback (e.g., artificial intelligence using one or more trained neural networks or other machine learning methods).

[0137] 5A and 5B show lateral and posterior views, respectively, of the lower segment of the spine. In certain implementations, these views, which may be live and / or recently captured images (e.g., fluoroscopic views) of the spine captured by the imaging system 824, may be displayed on the display screen 810 to aid in guidance. In certain configurations, the system 800 is configured to display an actual image or graphical representation 850 of the surgical tool 806 projected in the lateral and posterior views. Additionally, the system 800 may display trajectory aids, such as a projection line 852. In this manner, the display screen 810 may be used to display a projected and / or proposed trajectory of the tool being inserted through the tool holder 806.

[0138] FIG. 5C illustrates an image that can be generated by system 800 to assist in navigation. The image in FIG. 5C can correspond to a cross-sectional top view through the vertebrae. System 800 can be configured to create and display this view from an image from imaging system 800 and / or a model of the spine (e.g., a pre-operative model). Additionally, system 800 can display trajectory aids, such as projection lines 852. In this manner, display screen 810 can be used to display a projected trajectory and / or a proposed trajectory of a tool being inserted through tool holder 806.

[0139] The system 800 can allow the surgeon to physically manipulate the tool holder 806 to safely achieve proper alignment of the tool insertion through the tool holder 806 to perform critical steps in the surgical procedure (e.g., the initial insertion step, which affects the final trajectory of the subsequent access tool, which may be pre-curved). Manipulation of the robotic arm 803 by the surgeon (or other operator) in force-controlled mode can allow the tool to be moved in a measured manner that ignores the surgeon's accidental small movements. In this way, the surgeon can move the tool holder 806 to achieve the proper trajectory of the tool (e.g., a stylet) prior to manipulation or insertion of the tool into the patient. Once the robotic arm 803 is in the desired position, the arm 803 and tool holder 806 can be sequentially fixed to maintain the desired trajectory. The tool holder 806 can then serve as a stable and secure guide along which the tool can be moved or slid at precise angles.

[0140] FIG. 6 shows an exemplary configuration of a robotic arm 803. The robotic arm 803 can include an end effector 804 that can in turn hold a surgical instrument guide 806. A manipulator (not shown in FIG. 6 ), such as a handle, on the robotic arm 803 and / or near the end effector and / or off the cart can be used by a surgeon or other clinician for user-assisted and / or unassisted positioning and / or movement of the surgical instrument guide 806 to align the axes defined by the instrument guide 806 in a desired trajectory with respect to the patient's context. The axes can be aligned with the desired trajectory with respect to the patient's context via the manipulator using a display (e.g., the display of the augmented reality device 820) to help obtain the desired trajectory as described above.

[0141] The surgical instrument guide 806 is coupled to the robotic arm 803 to guide the instrument during surgery. For example, the surgical instrument guide 806 may be coupled to the robotic arm 803 via a flange. The surgical instrument guide 806 is configured to retain and / or limit the movement of a surgical instrument (e.g., an introducer assembly, a stylet drill, or a treatment device) therethrough. As shown in FIG. 6 , in some implementations, the surgical instrument guide 806 includes an introducer assembly 110, a curved cannula assembly 210, and a cannula through which tools, such as the treatment device 501 described above, can be inserted.

[0142] FIG. 7 illustrates in more detail an exemplary configuration of a surgical instrument guide 806 for use with the robotic surgical system 800. In some implementations, the same surgical instrument guide 806 is used to guide all instruments utilized by the robotic surgical system. For example, once a desired trajectory is selected, the robotic system 800 may not move during steps to access a bone (e.g., a vertebral body) and then may not move during steps to modulate nerves (e.g., basal nerves and / or other intraosseous nerves) within or adjacent to (e.g., surrounding) the bone (e.g., vertebral body). Such steps may include inserting an introducer assembly including an outer cannula and a sharp stylet, an inner cannula configured to be introduced through the outer cannula, and / or one or more access tools, such as additional stylets, curettes, or drills, to facilitate access to an intraosseous location within a vertebral body or other bone. A treatment device 501 can then be inserted into the introducer assembly to modulate (e.g., ablate or stimulate) the nerve. The path may be curved or straight.

[0143] 7 , surgical instrument guide 806 can include a rigid hollow tubular structure 807 having a first open end 807A and a second open end 807B. Surgical guide 806 can include one or more flanges that can be configured to secure guide 806 to an end effector of a robotic surgical system. Tubular structure 807 can define an insertion axis along which a surgical instrument slides through structure 807. That is, in certain configurations, tubular structure 807 can inhibit or limit movement except along a longitudinal axis defined by tubular structure 807. This insertion axis can correspond to a projected and / or proposed trajectory shown on a display (e.g., a display of an augmented reality device), as described above.

[0144] FIG. 8 shows a surgical instrument sliding through a surgical instrument guide 806. As described above, the guide 806 can include a notch 822 extending along the length of the guide 806. The surgical instrument (e.g., any one of the surgical instruments described herein, such as an access tool or a treatment device) can include an alignment pin that can slide through the notch 822. In this manner, the notch 822 allows the surgical instrument to slide along an axis defined by the guide while the guide is held in a fixed position by the robotic surgical system 800. In certain implementations, a navigational marker 812 can be provided on the alignment pin such that the navigational marker 812 is visible by the navigation camera along the full range of movement of the surgical instrument through the guide 806. FIG. 9 shows an introducer assembly 110 that can be modified to include an alignment pin 811 and a marker 812. As described above, alignment pin 811 can be used to slide introducer assembly 110 along an axis defined by guide 806 while guide 806 is held in a fixed position by robotic surgical system 800.

[0145] The guide 806 and tool 811 can include various sensors and markers configured to provide an indication of the relative depth to which the tool 811 has been inserted into the guide. This information can be used by the system 800 to help determine the position of the tool 811 relative to the patient's anatomy. In certain implementations, the tool may include a sensor or marker near or proximal to the end of the tool, and the position of the sensor or marker can be measured by the system and displayed on a display (e.g., the display of an augmented reality device) to assist the surgeon.

[0146] In certain applications, the robotic system 800 can use automated planning (e.g., a closed-loop mechanism). For example, in certain applications, the system 800 can be used to acquire medical images of a patient. These medical images can be obtained from MRI, CT, fluoroscopy, CT, or 3D fluoroscopy (or a combination of images from multiple imaging modalities). These images can be acquired preoperatively and provided to the system 800, as is often the case with MRI or CT, or can be provided intraoperatively, as is often the case with fluoroscopy, ultrasound, and 3D fluoroscopy. The patient can then be registered by locating and correlating the actual patient anatomy with the medical images. This can be done automatically for intraoperative medical imaging. For example, patient navigation markers can be attached to the spine or vertebrae or other parts of the patient before preoperative images are taken. The patient navigation markers can be recognized on the images by software, and by knowing the location of the imaging device, the medical images can be associated with the location of the patient navigation markers for further use. Other approaches to registering the patient can include manual point-to-point registration, surface matching, and fluoroscopy-based registration (e.g., intraoperative fluoroscopic images are matched with preoperative CT images).

[0147] In certain systems, trajectories can be automatically planned based on medical images acquired preoperatively or intraoperatively (from one or more imaging modalities). The automatic planning program can be configured to take preoperative or intraoperative medical images as input, recognize vertebrae based on these medical images, and propose an optimal trajectory or propose an initial trajectory that can be modified by the user. The automatic planning program may recognize sensitive anatomical structures (e.g., spinal tissue or nerves not intended for treatment) and display a warning indicator if the proposed trajectory encounters such sensitive anatomical structures and / or violates certain surgical guidelines.

[0148] A modified method of selecting a trajectory can be based on the user specifying a target or endpoint within the patient's vertebrae, and the system automatically presents one or more suggested trajectories based on specific rules or guides, or based on the known, preset curvature of the access tool and / or known or measured bone density. In another example, the user can position the robotic arm 803, whose position is known to the system 800, and the tool axis through the surgical guide tool at the end of the arm can be projected onto an image as described above with respect to FIGS. 5A and 5B. As described above, the surgeon can then be provided with a virtual projection of the trajectory (e.g., on the display of the robotic surgical system or an augmented reality device). Typically, the surgeon reviews the trajectory using lateral and anterior-posterior medical views (although other and / or additional views can be used as well).

[0149] Once a trajectory is selected, in certain implementations, the robot can automatically move the surgical guide tool to the trajectory as directed by the user. In other implementations, the user uses a display to manually control the movement of the robot so that one or more surgical guides inserted therein are positioned along the selection.

[0150] In certain configurations, the robotic system 800 includes a force sensor. The force sensor can be used to identify a collision by an increase in force (e.g., if the force sensor is not attempting to measure a force, the system can detect a collision if a force is detected). Similarly, additional sensors (e.g., artificial skin, laser scanners, electrical / capacitive proximity sensors, etc.) can be added to the robotic arm 803 for the purpose of detecting collisions. Upon detecting a collision, the robot can respond accordingly, such as by stopping or adapting its movement.

[0151] As mentioned above, in some implementations, rather than using automatic movement, the surgeon / user moves the robot "manually," as in hands-on planning (e.g., open-loop mechanisms). However, the robot may still provide assistance to the surgeon in finding a trajectory by providing haptic feedback (e.g., force and / or torque). This assistance can be provided by simulating attractive forces / torques to guide the surgeon to bring the robot to the target position. In certain implementations, these forces / torques make movement in the direction of the correct trajectory easier while preventing / making movement in other directions more difficult (e.g., by providing a resistive force). For example, a spring-like force (proportional to distance) or a magnetic-like force (proportional to the square of the distance) may be used to guide the user to the trajectory. Haptic feedback may be delivered to the user (e.g., surgeon) by an actuator associated with the robotic arm controlled by a processor. The amount (strength) of force feedback to be delivered to the user may be calculated in real time as a function of the position of the robotic arm relative to the calculated correct trajectory. Haptic feedback may be computed and delivered in association with a haptic guide, which may constrain to a particular area, point, and / or surface, or the haptic guide may provide detents or force fields to encourage movement toward a particular location in 3D space with a particular orientation (yaw, pitch, roll).

[0152] As described above, once the robot is along the correct trajectory, it can be locked in place. In embodiments in which the robot holds a surgical guide instrument, a manually controlled instrument may be inserted through the surgical guide instrument. In other implementations in which the surgical instrument is also controlled by the robotic arm, the user is allowed to move the surgical instrument only along the trajectory or rotate along the trajectory if tool rotation is not critical (e.g., if it is a line in space). In certain implementations, if the user attempts to move outward from the trajectory, a repulsive force is provided, thereby preventing the surgeon from moving the instrument outward from the trajectory. Similarly, movement along the length of the trajectory can be limited to prevent the tool from being inserted too far into the patient. Various other feedback mechanisms can be used, such as visual feedback (lighting, color change, etc.) and / or audio alerts when the surgeon deviates from the trajectory or advances the tool too far. For example, an alert may be displayed or sounded if there is a risk of overdrive.

[0153] In certain implementations, once positioned along a trajectory, a tool held by the robotic arm 803 may become misaligned with the trajectory due to, for example, patient movement (e.g., breathing), forces applied to the vertebrae, or overall table movement. In this case, an appropriate mode may be activated to provide assistance in re-finding the trajectory to move the robot to the correct new trajectory. In some cases, movement (e.g., of the patient or table) is measured, and the robot automatically responds to the movement (e.g., the system tracks the vertebrae). For example, in certain implementations, the robotic system 800 provides real-time compensation to follow the movement of the vertebrae. Thus, in certain implementations, the robotic system 800 is configured to automatically adjust the position of the instrument based on changes in the position of the vertebral body, such that the spatial relationship between the surgical instrument and the vertebral body remains substantially unchanged when at least a portion of an operation to ablate a basal nerve or other neuromodulation operation is performed. In certain configurations, the robotic system 800 automatically adjusts the position of the surgical instrument guide based on changes in the position of the vertebral body so that the spatial relationship between the surgical instrument guide and the vertebral body remains substantially unchanged when at least a portion of an operation to ablate a basilar nerve or other intraosseous nerve within the vertebral body, or other neuromodulation operation, is performed.

[0154] In an example of a method for modulating intraosseous or adjacent (e.g., periosseous) nerves, in some implementations, intraosseous nerves (e.g., basilar nerves) within a spinal bone (e.g., a vertebral body) are modulated for the treatment or prevention of chronic back pain. A surgeon or other operator / assistant identifies a trajectory or planned path for a surgical tool (e.g., a bone access introducer tool). In certain cases, the trajectory or path may be identified preoperatively, intraoperatively, or a combination thereof. The trajectory may be based on preoperative imaging of a particular patient's anatomy (e.g., one or more vertebral levels of the spine). The trajectory or path may be influenced by which vertebral body or bodies are targeted (e.g., the L4 vertebra, the L5 vertebra, the S1 vertebra). For example, the trajectory or planned path for the lumbar spine may differ from the trajectory or planned path for the sacrum. The trajectory or path may also be based on the patient's known or measured bone density or other bone structure characteristics. The trajectory or path may also take into account the location of the desired treatment site within the vertebral body. In the case of a transpedicular access approach, the trajectory or path may take into account that a curved approach may be required after exiting the pedicle to access the location of the desired treatment site (e.g., the predicted or known location of the basal nerve trunk or other intraosseous nociceptive nerves signaling from the vertebral endplate). In some implementations, the trajectory is defined by a computer algorithm (e.g., based on the selected access approach, the level of the vertebral body, the bone density of the vertebral body, the bony structure of the vertebral body, the specific patient anatomy surrounding the vertebral body, or other patient characteristics). The computer may define the trajectory or path with or without the assistance of the surgeon. In some implementations, the trajectory or path is presented to the surgeon for approval. Once the planned or desired trajectory or path is established, the trajectory or path may be transferred to the robotic system 700, 800 to perform the insertion of one or more access tools (e.g., an introducer assembly and / or an introducer drill) along the planned trajectory or path.

[0155] The surgeon then positions the end effector of the robotic arm (e.g., using a surgical guide) according to the desired trajectory or path. The positioning may or may not be assisted by the robotic surgical system. In some implementations, the surgeon may be assisted using various types of instructions, such as visual and / or audio instructions. The surgeon may be assisted through the use of an augmented reality device display. The augmented reality device display may include a virtual image of the desired trajectory or path to facilitate proper alignment of the surgical tool with the desired trajectory or path. The display may also include a 2D, 3D, or 4D virtual image (e.g., a virtual 3D model based on preoperative patient images) of the portion of the patient's spine below the skin, providing an enhanced user experience by allowing the surgeon to "visualize" (like "X-ray vision") the portion of the patient's spine requiring treatment and increasing the confidence in the trajectory or path. Visual or audio instructions may be provided to the surgeon via the augmented reality device. Augmented reality devices may be used with or without a robotic system, but may need to be used in conjunction with a navigation, imaging, alignment, or localization system such as those described above to determine the actual position of the surgical tool relative to a desired or planned trajectory or path.

[0156] After the position of the robotic arm 803 is fixed at the desired trajectory, the surgical instruments (e.g., the introducer assembly 110, the curved cannula assembly 210, the introducer drill 440, and / or the treatment device 501) are manipulated along the desired trajectory or path (e.g., as constrained by the surgical instrument guide). For example, the distal portion of the introducer assembly 110 (including the alignment pin 811 and / or marker 814) can be inserted through the pedicle adjacent to the vertebral body by inserting and advancing the introducer assembly 110 after the insert and aligned engagement of the introducer stylet 114 into the introducer cannula 112. The insertion can be monitored or supported by the surgeon using a display on the augmented reality device 820 to provide assurance of proper insertion. The display of the augmented reality device 820 can include a fluoroscopic imaging feed and / or a live video stream of still images or 3D models based on the patient's preoperative anatomical images. The surgeon may control advancement using an augmented reality device communicatively coupled to the control system or control console 801 of the robotic system 700, 800 or controls associated with the robotic system 700, 800 (e.g., voice-activated commands, via a joystick or other handheld controller). In some implementations, the robotic system 700, 800 may automatically control advancement without requiring surgeon control, and the surgeon need only monitor insertion by the robotic system 700, 800. The method may optionally include removing the introducer stylet 114 after initial penetration of the pedicle. The method may optionally include inserting the introducer drill 440 into and through the introducer cannula 112 (e.g., along a desired or planned trajectory or path) to complete pedicle traversal and penetration of the cortical bone region of the vertebral body until reaching the cancellous bone region of the vertebral body. The insertion of the introducer drill 440 may be monitored or guided by the surgeon using a display on the augmented reality device 820, or may be automated in a manner similar to that described above for the introducer assembly 110.As described below, one, some, or all of the tools inserted (e.g., via a surgical instrument guide) may include markers and / or sensors so that the robotic system 700, 800 can display the location of the tool's distal end to the user (e.g., on the display of an augmented reality device) to assist the user in the surgical procedure. Because the robotic system 700, 800 is used, some of the access tools may not be needed due to the precision and control provided by the robotic system 700, 800. Furthermore, some of the access tools may be introduced using the robotic system 700, 800, while others may be introduced manually by the surgeon.

[0157] After reaching the cancellous bone, the introducer drill 440 is removed, and the introducer stylet may be reinserted into the introducer cannula 112 and advanced to advance the distal tip of the introducer cannula 112 (e.g., along a desired or planned trajectory or path) to an entry site within the cancellous region of the vertebral body. The introducer stylet 114 may then be removed from the introducer cannula 112. In some implementations, fluoroscopic imaging is not used during insertion of the introducer tool (e.g., introducer assembly 110 and / or introducer drill 440) by the robotic system 700, 800, thereby reducing radiation exposure.

[0158] The curved cannula assembly 210 may then be inserted into the introducer cannula 112 and advanced along a desired or planned trajectory or path. When the curved cannula assembly 210 is advanced by coupling to a robotic system, the advancement may be automatically adjusted by the robotic system if the actual path deviates from the planned trajectory or path. For example, the curved cannula assembly 210 may be partially or fully retracted and advanced again to more accurately follow the planned trajectory or path. In some implementations, the robotic system or the surgeon may determine that the current curved cannula assembly should be replaced with a different curved cannula assembly having a different preset radius of curvature. In some implementations, a steerable or bendable channeling instrument may be used in place of the curved cannula assembly 210 to facilitate active adjustments to steering without relying on a pre-curved device.

[0159] A treatment device (e.g., a flexible bipolar radiofrequency probe) 501 may be inserted through the curved cannula 212 (e.g., after removing the J-stylet 214 from the curved cannula 212) and advanced from the open distal tip of the curved cannula 212 to the target treatment location. If a steerable channeling instrument is used instead of a curved cannula assembly, the treatment device 501 may be inserted along the curved path formed by the steerable channeling instrument. The treatment device 501 may be inserted manually by a surgeon or other operator, or automatically by coupling to a robotic system 700, 800. The treatment device 501 may then be used to perform the desired treatment. For example, if the treatment device 501 is a radiofrequency probe, the treatment device 501 may be actuated to ablate an intraosseous nerve (e.g., the basilar nerve) or a tumor within a vertebral body. Bone cement or other medications, or diagnostic devices (such as a nerve stimulator or imaging device to confirm nerve ablation) may optionally be delivered through the curved cannula 212 after the treatment device is removed from the curved cannula.

[0160] The display of the augmented reality device 820 may be used by the surgeon or other operator to monitor the procedure (e.g., monitor treatment parameters from the radiofrequency generator's display, which may be replicated on the display of the augmented reality device 820). In some implementations, the robotic system and / or the augmented reality device are used to facilitate insertion of the introducer access tool (e.g., the introducer assembly 110 and / or the introducer drill 440), but the robotic system 700, 800 and / or the augmented reality device 820 are not used to insert other access tools or treatment devices (e.g., the curved cannula assembly 210, the steerable channeling instrument, the treatment device 501). For example, the robotic system 700, 800 and / or the augmented reality device 820 may be used only to facilitate access from the skin insertion location to a location within the cancellous portion of the vertebral body. In other implementations, the robotic system 700, 800 and / or the augmented reality device 820 are used for all of the access and treatment steps.

[0161] In certain implementations, a sterile barrier can be formed between portions of the robotic system 800 and the patient. For example, in certain instances, a sterile drape is provided that is configured to maintain sterility, allow for sterile placement of surgical tools into the sterile field, and further allow for sterile removal of the surgical tools for manual manipulation.

[0162] According to some examples, any of the access or treatment instruments or devices described herein may include one or more sensors, tracking devices, or positioning markers (e.g., positioning beads, optical markers, GPS sensors) configured to facilitate detection or identification of the instrument by existing commercially available (e.g., non-proprietary) spinal robotic surgical guidance or navigation systems, instead of requiring a specially tailored and configured robotic system specifically designed for the particular access or treatment instrument. The positioning markers may be attached to or integrated into the access or treatment instrument or device. The spinal robotic guidance or navigation system may be adapted to detect and / or identify various instruments and track or manipulate (e.g., control) the instruments.

[0163] Feedback from the robotic systems described herein can be combined with other inputs or information described herein to provide an optimal solution for a particular patient situation. For example, feedback determined from one or more imaging modalities indicating premodal change characteristics (e.g., vertebral endplate degeneration or endplate defects or multifidus atrophy) or other symptoms can be combined with feedback or information from the robotic system to adjust treatment parameters or target regions. For example, PET scans, single-photon emission CT, or MRI scans can indicate areas of inflammation, which can indicate areas indicating the presence or potential presence of premodal change characteristics. This imaging input (along with other inputs described herein, such as information regarding biomarker activity or levels, nerve location based on nerve detection techniques, or other information) can be combined with feedback from the robotic system to determine the desired target region within the vertebral body and / or the desired ablation parameters (e.g., thermal dose, lesion size, shape, duration, temperature, etc.).

[0164] According to some implementations, target or candidate vertebrae for treatment can be identified prior to treatment. Target or candidate vertebrae can be identified based on identifying various types or factors associated with endplate degeneration and / or defects (e.g., focal defects, erosive defects, rim defects, corner defects, all of which can be considered premodic change characteristics).

[0165] For example, one or more imaging modalities (e.g., MRI, CT, X-ray, fluoroscopic imaging) may be used to determine whether a vertebral body or vertebral endplate exhibits active Modic or "pre-Modic change" characteristics (e.g., features likely to result in Modic change, such as Type 1 Modic change, which includes findings of inflammation and edema, or Type 2 Modic change, which includes changes in bone marrow (e.g., fibrosis) and increased visceral fat content). For example, images obtained via MRI (e.g., ideal MRI) may be used to identify early signs or precursors of edema or inflammation in the vertebral endplate (e.g., via application of one or more filters) prior to formal characterization or diagnosis as Type 1 Modic change.

[0166] Examples of pre-modic change characteristics include mechanical characteristics (e.g., loss of soft nuclear material in the disc adjacent to a vertebral body, loss of disc height, loss of hydrostatic pressure, microfractures, focal endplate defects, erosive endplate defects, rim endplate defects, angular endplate defects, osteitis, spondylodiscitis, Schmorl's nodes) or bacterial characteristics (e.g., detection of bacteria that have entered the disc adjacent to a vertebral body, disc herniation or annular tears that may have allowed bacteria to enter the disc, inflammation or new capillary formation that may be caused by bacteria), or other pathogenic mechanisms that provide early signs or precursors of potential modic change or vertebral endplate degeneration or loss.

[0167] Thus, vertebral bodies may be identified as potential targets for treatment before Modic changes occur (or before painful symptoms appear in the patient), allowing the patient to be proactively treated before chronic back pain occurs, preventing or reducing the likelihood of chronic back pain. In this way, the patient does not need to suffer from debilitating back pain for a period of time before treatment. Modic changes may or may not be correlated with endplate defects and may or may not be used to select or screen candidates. In some embodiments, Modic changes are not evaluated, and only vertebral endplate degeneration and / or defects (e.g., pre-modic change characteristics prior to the onset or ability to identify Modic changes) are identified. The rostral and / or caudal endplates may be evaluated for pre-modic changes (e.g., endplate defects that appear before Modic changes, which may affect the subchondral and vertebral bone marrow adjacent to the vertebral endplate).

[0168] The systems and methods described herein may also include evaluation of one or more biomarkers (e.g., biomarkers related to pain, inflammation, or neurotransmission). Biomarkers may also be used to assess whether a particular subject is likely to be a candidate for nerve ablation treatment for the treatment of back pain. For example, biomarkers may indicate symptoms (e.g., inflammation, edema, bone marrow lesions, or fibrosis) that are likely to lead to pre-modic changes or modic changes or endplate damage. Evaluation of biomarker levels may indicate which vertebral bodies in a particular subject are candidates for treatment to prevent (or reduce the likelihood of) the onset or worsening of back pain or to treat existing back pain. Pre-treatment biomarker evaluation may also be combined with pre-treatment imaging. Biomarkers may include one or more of inflammatory cytokines (e.g., interleukins, interferons, tumor necrosis factors, prostaglandins, and chemokines), pain indicators (e.g., substance P, calcitonin gene-related peptide (CGRP)), edema factors, and / or other inflammatory factors. Biomarkers may be obtained, for example, from one or more serum samples (e.g., plasma). Biomarkers may be obtained over an extended period of time (e.g., over a period of days, weeks, or months) or at a single time instance. Biomarkers may also be identified in the image itself, and may be tissue features, changes in bone marrow intensity, or other variations as described above. Evaluation of biomarkers may include application of a trained neural network based on biomarker measurements of several (e.g., hundreds) of back pain patients previously obtained and used to train the neural network.

[0169] In some implementations, levels of one or more biomarkers (e.g., substance P, cytokines, high-sensitivity C-reactive protein, or other compounds associated with inflammatory processes and / or pain and / or correlated with vertebral endplate degeneration or loss (e.g., premodical changes) or pathophysiological processes associated with modal changes such as disc resorption, degradation and formation of types III and IV collagen, or myelofibrosis) may be obtained from the patient (e.g., via a blood (e.g., serum) or cerebrospinal fluid sample) to determine whether the patient is a candidate for basal nerve ablation treatment (e.g., whether they have one or more candidate vertebrae that exhibit factors or symptoms associated with endplate degeneration or loss (e.g., premodal changes characteristic)). Cytokine biomarker samples (e.g., proangiogenic serum cytokines such as vascular endothelial growth factor (VEGF)-C, VEGF-D, tyrosine-protein kinase receptor 2, VEGF receptor 1, intercellular adhesion molecule 1, and vascular cell adhesion molecule 1) can be obtained from multiple different discs or vertebral bodies or foramina of a patient and compared to each other to determine which vertebral bodies to target for treatment. Other biomarkers, such as neoepitopes of type III and type IV procollagen (e.g., PRO-C3, PRO-C4) and type III and type IV collagen degradation neoepitopes (e.g., C3M, C4M), can also be evaluated.

[0170] Biomarkers may include genetic markers, gene expression products, autoantibodies, cytokines / growth factors, proteins or enzymes (such as heat shock proteins), and / or acute phase reactants. Biomarkers may include compounds that correlate with back pain, such as inflammatory cytokines, interleukin-1-beta (IL-1-beta), interleukin-1-alpha (IL-1-alpha), interleukin-6 (IL-6), IL-8, IL-10, IL-12, tumor necrosis factor-alpha (TNF-alpha), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-gamma), prostaglandin E2 (PGE2), aggrecan, proteoglycan, or glycosaminoglycan. Biomarkers may also indicate the presence of tumor cells or tissue if tumor tissue is targeted by treatment. Biomarkers may be found in serum / plasma, urine, synovial fluid, tissue biopsies, foramina, disc, cerebrospinal fluid, or cells from blood, body fluids, lymph nodes, and / or tissues (including, for example, deviations from a healthy disc, such as abnormal pH levels, or disc damage, including, for example, a ruptured, degenerated, or prolapsed disc, nucleus pulposus, fluid leak, or other damage impinging on a nerve resulting in pain and / or inflammation). In some embodiments, the biomarker may be an indicator identified from an image.

[0171] In some implementations, samples are obtained over a period of time and compared to determine changes in levels over time. For example, biomarkers may be measured weekly, bimonthly, monthly, quarterly, or six months over a period of time and compared to analyze trends or changes over time. If significant changes are observed between biomarker levels (e.g., changes indicative of endplate degeneration or loss (e.g., characteristic of premodic changes) or modic changes as described above), treatment may be recommended and implemented to prevent or treat back pain.

[0172] Biomarker levels (e.g., substance P, cytokine protein levels, PRO-C3, PRO-C4, C3M, C4M levels, abnormal pH levels, or intervertebral disc damage) can be measured using a variety of in vivo or in vitro kits, systems, and techniques (e.g., radioimmunoassay kits / methods, enzyme-linked immunosorbent assay kits, immunohistochemistry techniques, array-based systems, bioassay kits, in vivo injection of anti-cytokine immunoglobulins, multiplexed fluorescent microsphere immunoassays, homogeneous time-resolved fluorescent assays, bead-based techniques, interferometry, flow cytometry, etc.). Cytokine proteins can be measured directly or indirectly, such as by measuring mRNA transcripts.

[0173] According to some implementations, biomarkers may be used to confirm treatment efficacy (e.g., whether the treatment resulted in effective ablation of the basal nerve within the vertebral body or the intraosseous nerve within another bone, achieving the desired treatment response). Biomarkers may include anatomical, physiological, biochemical, molecular parameters, or imaging features that can be used to confirm treatment efficacy. Biomarkers can be detected and measured by various methods, including, but not limited to, physical examination, laboratory assays (such as blood samples), and medical imaging. Biomarkers may be obtained via biological tissue sampling or minimally invasively (e.g., from blood, saliva, cerebrospinal fluid, or urine). Tissue imaging may also be used to detect and measure biomarkers.

[0174] Measurement of biomarker levels can utilize one or more capture or detection agents that specifically bind to the biomarker, such as a labeled antibody that binds to and detects the biomarker. In some implementations, measurement of the biomarker can utilize a detection agent that functionally interacts with the biomarker. In other implementations, measurement of the biomarker can be performed using imaging / spectroscopy techniques that allow biomarker levels to be assessed noninvasively or via tissue sampling. A capture or detection agent may be used. In some implementations, binding of the biomarker to the capture agent and / or interaction of the biomarker with the detection agent results in a quantitative or detectable signal. The signal may include, for example, a colorimetric signal, a fluorescent signal, a thermal signal, an energy signal, or an electrical signal. The detectable quantitative signal may be transmitted to an external output or monitoring device. In some implementations, binding of the biomarker to the capture agent results in a signal that can be transmitted to an external monitoring device. For example, binding of the biomarker to the capture or detection agent can be detected using highly sensitive fluorescence techniques such as resonance energy transfer (e.g., Förster resonance energy transfer, bioluminescence resonance energy transfer, or surface plasmon resonance energy transfer).

[0175] In various implementations, measurements of pre- and post-treatment biomarker levels can be performed using the same device used to perform the treatment (e.g., ablation, denervation) or components attached to the treatment device. Alternatively, biomarker levels or activity can be performed using a device separate from the treatment device. A separate biomarker assessment device can be inserted through the same introducer as the treatment device or a separate introducer.

[0176] One or more samples, images, and / or measurements may be obtained from the patient before and after treatment, and the presence of one or more biomarkers in the pre- and post-treatment samples may be compared to confirm the effectiveness of the treatment. The comparison may include a comparison of the level or activity of the biomarkers in the samples. For example, there may be a burst or spike in biomarker concentration after ablation of the basal nerve trunk or its branches, which can be detected or measured in the collected biological sample.

[0177] As another example, changes in biomarker levels or activity may be an indirect response to ablation of the basal nerve trunk or its branches (e.g., inflammatory or anti-inflammatory proteins, such as cytokine proteins, heat shock proteins, or stress response proteins triggered in response to ablation energy applied to the target treatment area, or non-protein biomarkers associated with neural activity, such as catecholamines, neurotransmitters, norepinephrine levels, neuropeptide Y levels, epinephrine levels, and / or dopamine levels). Post-treatment samples may be obtained immediately after treatment (e.g., within seconds after treatment, within about 15 minutes after treatment, or within about 30 minutes after treatment) and / or at a more significant time after treatment (e.g., 24 hours after treatment, 3 days after treatment, 1 week after treatment, 2 weeks after treatment, 1 month after treatment, 3 months after treatment, 6 months after treatment).

[0178] Various inputs (e.g., biomarker activity or levels, physiological parameter measurements indicative of neuronal activity, temperature measurements, impedance measurements, and / or images) may be combined (e.g., weighted combination) to generate a quantitative pain score that can be used to confirm pain relief (as an adjunct to, or as an alternative to, subjective pain relief confirmation). The pain score may be generated using an automated algorithm executed by a processor of the pain analyzer system. The pain analyzer system may receive inputs from various sensors, imaging devices, etc., which may be weighted and / or processed by one or more circuits or processing modules of the pain analyzer system to generate a quantitative pain score. The quantitative pain score may be output to a display (e.g., of the generator).

[0179] conclusion In some implementations, the system includes various features that exist as a single feature (rather than multiple features). For example, in one embodiment, the system includes a single radiofrequency generator, a single introducer cannula with a single stylet, a single radiofrequency energy delivery device or probe, and a single bipolar electrode pair. A single thermocouple (or other means for measuring temperature) may also be included. In alternative embodiments, multiple features or components are provided.

[0180] In some implementations, the system comprises one or more of a tissue adjustment means (e.g., an ablation or other type of adjustment catheter or delivery device), a means for monitoring temperature (e.g., a thermocouple, thermistor, infrared sensor), a means for imaging (e.g., MRI, CT, fluoroscopy), a means for accessing (e.g., an introducer assembly, a curved cannula, a drill, a curette), a means for actuating (e.g., a threaded knob or screw actuation mechanism, a slide actuator, a pull wire actuator, a lever, a hydraulic actuator, a pneumatic actuator, an electric actuator, a push button actuator, a mechanical linear actuator, etc.).

[0181] While specific embodiments and examples have been described herein, aspects of the methods and apparatus shown and described in this disclosure may be differently combined and / or modified to form further embodiments. Furthermore, the methods described herein may be practiced using any apparatus suitable for performing the recited steps. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc., disclosed herein (including the drawings) related to various embodiments may be used in all other embodiments described herein. Section headings used herein are provided solely for ease of reading and are not intended to limit the scope of the embodiments disclosed in a particular section to the features or elements disclosed in that section.

[0182] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. It should be understood, however, that the embodiments are not limited to the particular forms or methods disclosed; on the contrary, the embodiments encompass all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. The methods disclosed herein need not be performed in the order listed. The methods disclosed herein include specific actions performed by a practitioner. However, they may also include, explicitly or implicitly, any third-party instruction of those actions. For example, an action such as "apply thermal energy" includes "commanding the application of thermal energy."

[0183] The terms "top," "bottom," "first," "second," "upper," "lower," "height," "width," "length," "end," "side," "horizontal," "vertical," and similar terms may be used herein. It should be understood that these terms refer only to the structures shown in the figures and are utilized solely to facilitate the description of the embodiments of the present disclosure. The terms "proximal" and "distal" are opposite terms. For example, the distal end of a device or component is the end of the component farthest from the surgeon during normal use. The distal end or tip does not necessarily refer to the furthest distal terminus. The proximal end refers to the opposite end, or the end closest to the surgeon during normal use. Various embodiments of the present disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. The ranges disclosed herein encompass any and all overlaps, subranges, and combinations thereof, as well as individual numerical values ​​within the range. For example, description of a range such as 70 degrees to 115 degrees should be considered to specifically disclose subranges such as 70 degrees to 80 degrees, 70 degrees to 100 degrees, 70 degrees to 110 degrees, 80 degrees to 100 degrees, etc., as well as individual numbers within that range, e.g., 70, 80, 90, 95, 100, 70.5, 90.5, and any whole and partial increments therebetween. Phrases such as "up to," "at least," "greater than," "less than," "between," and the like, include the recited numbers. Numbers preceded by terms such as "about" or "approximately" include the recited numbers. For example, "about 2:1" includes "2:1." For example, as used herein, the terms "approximately," "about," and "substantially" refer to an amount near the recited amount that still performs a desired function or achieves a desired result.

Claims

1. 1. A robotic system for facilitating intraosseous nerve ablation, comprising: an operator control console comprising a computer-based control system including at least one processor configured to execute program instructions stored on a non-transitory computer-readable medium to perform an intraosseous nerve ablation procedure to ablate intraosseous nerves within a vertebral body; one or more robotic surgical arms configured to move with six or more degrees of freedom and to support or carry an access tool or treatment device; a tracking system that can be used to capture the position of at least a portion of a patient, the access tool or treatment device, and the one or more robotic surgical arms; a display, wherein the computer-based control system is configured to display a desired trajectory directed to a target treatment site within the vertebral body for performing the intraosseous nerve ablation procedure.

2. The robotic system of claim 1 , wherein the computer-based control system uses a closed-loop system to control the automated insertion of the access tool or treatment device.

3. The robotic system of claim 2 , wherein the closed-loop system incorporates feedback based on one or more trained neural networks.

4. 10. The robotic system of claim 1, wherein the computer-based control system is configured to receive input from a user via the operator control console to modify the desired trajectory directed toward the target treatment site.

5. The robotic system of claim 1 , wherein the display comprises a see-through display on an augmented reality headset or eyewear, and the robotic system is configured for a user to operate in an augmented reality environment.

6. The robotic system of claim 1 , wherein the one or more robotic surgical arms are carried by a mobile cart.

7. 6. The robotic system of claim 1, further comprising a surgical instrument guide configured to be coupled to the one or more robotic surgical arms to facilitate guided insertion of the access tool or treatment device along the desired trajectory.

8. The robotic system of claim 1 , wherein the operator control console comprises an augmented reality device.

9. 1. A system for facilitating nerve ablation, comprising: a surgeon control console comprising a computer-based control system including at least one processor configured to execute program instructions stored on a non-transitory computer-readable medium to perform a nerve ablation procedure to ablate intraosseous nerves within one or more vertebral bodies; a robotic surgical arm configured to move with at least three degrees of freedom and to support a surgical instrument guide; a tracking system for capturing the position of the robotic surgical arm; an access assembly and / or a radiofrequency energy delivery device configured to be inserted through the surgical instrument guide.

10. The system of claim 9 , wherein the computer-based control system is configured to provide feedback to a user to control insertion of the access assembly and / or the radiofrequency energy delivery device.

11. The system of claim 9 , wherein the computer-based control system uses a closed-loop system to control insertion of the access assembly and / or the radiofrequency energy delivery device.

12. 12. The system of claim 9, wherein the computer-based control system is configured to display to a user of the system on a display a desired trajectory directed toward a target treatment site within a vertebral body.

13. The system of claim 12 , wherein the desired trajectory is displayed as a virtual image on a display of an augmented reality device.

14. The system of claim 12 , wherein the desired trajectory is configured to terminate in a region that includes a basal nerve trunk.

15. The system of claim 12 , wherein the desired trajectory is determined based on pre-operative images of the spinal anatomy surrounding and including the vertebral body.

16. The system of claim 12 , wherein the desired trajectory is determined based on particular characteristics of the vertebral body.

17. The system of claim 16 , wherein the characteristics include bone structure characteristics.

18. The system of claim 17 , wherein the bone structural characteristics include bone density.

19. The system of claim 16 , wherein the characteristics include an anatomical identification of the vertebral body by vertebral level and number.

20. 12. The system of claim 9, wherein the robotic surgical arm has at least six degrees of freedom.

21. 1. A robotic system for facilitating nerve ablation in a patient, comprising: a surgeon control console comprising a computer-based control system including at least one processor; one or more robotic surgical arms configured to move with six or more degrees of freedom and to support or carry a surgical instrument; a tracking system configured to capture a position of at least a portion of the patient and the one or more robotic surgical arms; at least one display; at least one user interface; the computer-based control system is configured to generate a virtual trajectory; the virtual trajectory is a virtual axis, the virtual axis being a three-dimensional digital representation illustrating a desired insertion path of multiple instruments toward a target site within a vertebral body; The robotic system, wherein the target site corresponds to the location of a basal nerve trunk within the vertebral body.

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