Levels of autonomy in FDA-cleared surgical robots: a systematic review.

The integration of robotics in surgery has increased over the past decade, and advances in the autonomous capabilities of surgical robots have paralleled that of assistive and industrial robots. However, classification and regulatory frameworks have not kept pace with the increasing autonomy of surgical robots. There is a need to modernize our classification to understand technological trends and prepare to regulate and streamline surgical practice around these robotic systems. We present a systematic review of all surgical robots cleared by the United States Food and Drug Administration (FDA) from 2015 to 2023, utilizing a classification system that we call Levels of Autonomy in Surgical Robotics (LASR) to categorize each robot's decision-making and action-taking abilities from Level 1 (Robot Assistance) to Level 5 (Full Autonomy). We searched the 510(k), De Novo, and AccessGUDID databases in December 2023 and included all medical devices fitting our definition of a surgical robot. 37,981 records were screened to identify 49 surgical robots. Most surgical robots were at Level 1 (86%) and some reached Level 3 (Conditional Autonomy) (6%). 2 surgical robots were recognized by the FDA to have machine learning-enabled capabilities, while more were reported to have these capabilities in their marketing materials. Most surgical robots were introduced via the 510(k) pathway, but a growing number via the De Novo pathway. This review highlights trends toward greater autonomy in surgical robotics. Implementing regulatory frameworks that acknowledge varying levels of autonomy in surgical robots may help ensure their safe and effective integration into surgical practice.

Bone Cements Used in Vertebral Augmentation: A State-of-the-art Narrative Review.

Vertebral compression fractures (VCFs) are common in osteoporotic patients, with a frequency projected to increase alongside a growing geriatric population. VCFs often result in debilitating back pain and decreased mobility. Cement augmentation, a minimally invasive surgical technique, is widely used to stabilize fractures and restore vertebral height. Acrylic-based cements and calcium phosphate cements are currently the two primary fill materials utilized for these procedures. Despite their effectiveness, acrylic bone cements and calcium phosphate cements have been associated with various intraoperative and postoperative incidents impacting VCF treatment. Over the past decade, discoveries in the field of biomedical engineering and material science have shown advancements toward addressing these limitations. This narrative review aims to assess the potential pitfalls and barriers of the various types of bone cements.

Surgical techniques for evacuation of chronic subdural hematoma: a mini-review.

Chronic subdural hematoma is one of the most common neurosurgical pathologies with over 160,000 cases in the United States and Europe each year. The current standard of care involves surgically evacuating the hematoma through a cranial opening, however, varied patient risk profiles, a significant recurrence rate, and increasing financial burden have sparked innovation in the field. This mini-review provides a brief overview of currently used evacuation techniques, including emerging adjuncts such as endoscopic assistance and middle meningeal artery embolization. This review synthesizes the body of available evidence on efficacy and risk profiles for each critical aspect of surgical technique in cSDH evacuation and provides insight into trends in the field and promising new technologies.

Endoscopic odontoidectomy for brainstem compression in association with posterior fossa decompression and occipitocervical fusion.

OBJECTIVE: Endonasal endoscopic odontoidectomy (EEO) is an alternative to transoral surgery for symptomatic ventral compression of the anterior cervicomedullary junction (CMJ), allowing for earlier extubation and feeding. Because the procedure destabilizes the C1-2 ligamentous complex, posterior cervical fusion is often performed concomitantly. The authors' institutional experience was reviewed to describe the indications, outcomes, and complications in a large series of EEO surgical procedures in which EEO was combined with posterior decompression and fusion. METHODS: A consecutive, prospective series of patients who underwent EEO between 2011 and 2021 was studied. Demographic and outcome metrics, radiographic parameters, extent of ventral compression, extent of dens removal, and increase in CSF space ventral to the brainstem were measured on the preoperative and postoperative scans (first and most recent scans). RESULTS: Forty-two patients (26.2% pediatric) underwent EEO: 78.6% had basilar invagination, and 76.2% had Chiari type I malformation. The mean ± SD age was 33.6 ± 3.0 years, with a mean follow-up of 32.3 ± 4.0 months. The majority of patients (95.2%) underwent posterior decompression and fusion immediately before EEO. Two patients underwent prior fusion. There were 7 intraoperative CSF leaks but no postoperative CSF leaks. The inferior limit of decompression fell between the nasoaxial and rhinopalatine lines. The mean ± SD vertical height of dens resection was 11.98 ± 0.45 mm, equivalent to a mean ± SD resection of 74.18% ± 2.56%. The mean increase in ventral CSF space immediately postoperatively was 1.68 ± 0.17 mm (p < 0.0001), which increased to 2.75 ± 0.23 mm (p < 0.0001) at the most recent follow-up (p < 0.0001). The median (range) length of stay was 5 (2-33) days. The median time to extubation was 0 (0-3) days. The median time to oral feeding (defined as, at minimum, toleration of a clear liquid diet) was 1 (0-3) day. Symptoms improved in 97.6% of patients. Complications were rare and mostly associated with the cervical fusion portion of the combined surgical procedures. CONCLUSIONS: EEO is safe and effective for achieving anterior CMJ decompression and is often accompanied by posterior cervical stabilization. Ventral decompression improves over time. EEO should be considered for patients with appropriate indications.

Combined transarterial and percutaneous preoperative embolization of transosseous meningioma.

Meningiomas with transosseous extension provide opportunities for extensive preoperative embolization, through conventional trans-arterial approaches, and also through less commonly used percutaneous methods. This video demonstrates embolization of a 7.6 × 9.5 × 9.9 cm transosseous WHO grade II meningioma.1 Trans-arterial embolization was conducted via the left middle meningeal, occipital, and superficial temporal arteries. Only one superficial temporal artery was embolized to preserve vascular supply to the skin flap. To further devascularize the tumor, concomitant percutaneous embolization was performed. Transosseous extension of the tumor facilitated extensive percutaneous embolization of both the intracranial and extracranial components of the mass. Intraoperative bleeding from the scalp and extracranial component of the tumor was minimal. The intracranial tumor was soft and necrotic and was removed with suction and gentle dissection. Residual tumor was left behind within and adjacent to the superior sagittal sinus. The patient recovered without neurological deficit and was referred for radiation of the residual tumor.

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique.

BACKGROUND: Middle meningeal artery (MMA) embolization has been recognized as a promising treatment for patients with subdural hematoma (SDH). OBJECTIVE: To present the technical feasibility and efficacy of n-butyl cyanoacrylate (n-BCA) embolization in the largest consecutive cohort to date. METHODS: We retrospectively reviewed our consecutive cases of recurrent SDH treated with MMA embolization using diluted n-BCA with the "sugar rush" technique. In brief, a 2.1-Fr microcatheter was used to selectively catheterize the frontal and posterior branches of the MMA. 5% dextrose in water (D5W) was injected through an intermediate catheter while injecting n-BCA through the microcatheter. Complete obliteration of MMA and lack of SDH recurrence in a 3-6 months follow-up computed tomography scan were defined as efficacy outcomes. Cranial nerve palsy, vision loss, transient neurological deficit, and stroke were defined as safety outcomes. RESULTS: A total of 61 patients were identified with a mean (±standard deviation) age of 62.5 ± 9 years. In 6 patients (10%), coil embolization of the origin of the frontal or posterior branch was performed because super-selective catheterization of the branch was unsuccessful because of tortuous anatomy. Complete obliteration of frontal and posterior branches was achieved in 100% of the cases. Recurrent SDH was seen in 3 patients (5%). No incidence of cranial nerve palsy, vision loss, or stroke occurred. One patient suffered a transient neurological deficit. CONCLUSION: MMA embolization using diluted n-BCA with concomitant D5W injection is associated with a high degree of distal penetration and complete branch occlusion and minimal risk of cranial nerve palsy or other thromboembolic complications.

Robotic Resection of a Nerve Sheath Tumor Via a Retroperitoneal Approach.

BACKGROUND: Resection of large nerve sheath tumors in the lumbar spine using minimally invasive approaches is challenging, as approaches to tumors in this region may require facetectomy or partial resection of adjacent ribs for access to the involved neuroforamen and instrumentation across the involved joint to prevent subsequent kyphotic deformity. OBJECTIVE: To describe a robot-assisted retroperitoneal approach for resection of a lumbar nerve sheath tumor, obviating the need for facetectomy and instrumentation. The operation is described, together with intraoperative images and an annotated video, in the context of a schwannoma arising from the right L1 root. METHODS: The operation was performed by a urologic surgeon and a neurosurgeon. The patient was placed in lateral position, and the da Vinci Xi robot was used for retroperitoneal access via 5 ports along the right flank. Ultrasound was used to localize the tumor within the psoas. The tumor capsule was defined and released. Encountered nerves were stimulated, allowing small sensory nerves to be identified and safely divided. The tumor was traced into the right L1-L2 neuroforamen and removed. RESULTS: Complete en bloc resection of the tumor was achieved, including the paraspinal and foraminal components, without any removal of bone and without violation of the dura. CONCLUSION: In selected patients, a robot-assisted retroperitoneal approach represents a minimally invasive alternative to traditional approaches for resection of lumbar nerve sheath tumors. This approach obviates the need for bone removal and instrumented spinal fusion. Interdisciplinary collaboration, as well as use of adjunctive technologies, including intraoperative ultrasound and neurophysiologic monitoring, is advised.

Limited utility of 5-ALA optical fluorescence in endoscopic endonasal skull base surgery: a multicenter retrospective study.

OBJECTIVE: Incomplete resection of skull base pathology may result in local tumor recurrence. This study investigates the utility of 5-aminolevulinic acid (5-ALA) fluorescence during endoscopic endonasal approaches (EEAs) to increase visibility of pathologic tissue. METHODS: This retrospective multicenter series comprises patients with planned resection of an anterior skull base lesion who received preoperative 5-ALA at two tertiary care centers. Diagnostic use of a blue light endoscope was performed during EEA for all cases. Demographic and tumor characteristics as well as fluorescence status, quality, and homogeneity were assessed for each skull base pathology. RESULTS: Twenty-eight skull base pathologies underwent blue-light EEA with preoperative 5-ALA, including 15 pituitary adenomas (54%), 4 meningiomas (14%), 3 craniopharyngiomas (11%), 2 Rathke's cleft cysts (7%), as well as plasmacytoma, esthesioneuroblastoma, and sinonasal squamous cell carcinoma. Of these, 6 (21%) of 28 showed invasive growth into surrounding structures such as dura, bone, or compartments of the cavernous sinus. Tumor fluorescence was detected in 2 cases (7%), with strong fluorescence in 1 tuberculum sellae meningioma and vague fluorescence in 1 pituicytoma. In all other cases fluorescence was absent. Faint fluorescence of the normal pituitary gland was seen in 1 (7%) of 15 cases. A comparison between the particular tumor entities as well as a correlation between invasiveness, WHO grade, Ki-67, and positive fluorescence did not show any significant association. CONCLUSIONS: With the possible exception of meningiomas, 5-ALA fluorescence has limited utility in the majority of endonasal skull base surgeries, although other pathology may be worth investigating.

Innovations in the Neurosurgical Management of Epilepsy.

Technical limitations and clinical challenges have historically limited the diagnostic tools and treatment methods available for surgical approaches to the management of epilepsy. By contrast, recent technological innovations in several areas hold significant promise in improving outcomes and decreasing morbidity. We review innovations in the neurosurgical management of epilepsy in several areas, including wireless recording and stimulation systems (particularly responsive neurostimulation [NeuroPace]), conformal electrodes for high-resolution electrocorticography, robot-assisted stereotactic surgery, optogenetics and optical imaging methods, novel positron emission tomography ligands, and new applications of focused ultrasonography. Investigation into genetic causes of and susceptibilities to epilepsy has introduced a new era of precision medicine, enabling the understanding of cell signaling mechanisms underlying epileptic activity as well as patient-specific molecularly targeted treatment options. We discuss the emerging path to individualized treatment plans, predicted outcomes, and improved selection of effective interventions, on the basis of these developments.

Transforaminal Endoscopic Lumbar Discectomy and Foraminotomy with Modified Radiofrequency Nerve Stimulator and Continuous Electromyography Under General Anesthesia.

BACKGROUND: Transforaminal endoscopic lumbar approaches involve working in Kambin's triangle. These procedures are performed on awake patients or under general anesthesia with continuous electromyography. Potential morbidity of this approach includes injury to exiting and traversing nerve roots, as substantial dissection or cauterization of overlying tissues is required for visualization. METHODS: We developed a novel connection system that accepts input from a bipolar radiofrequency probe to allow direct nerve stimulation in conjunction with electromyography. This study included 30 consecutive patients undergoing transforaminal endoscopic lumbar approaches for discectomies (73.3%), foraminal stenosis (23.3%), or lateral recess stenosis (3.3%). Demographic, operative, and outcomes data were collected. RESULTS: Average age of patients was 61.4 years, and the L4-5 segment was most commonly treated (65.6%). Electrophysiologic mapping of the exiting nerve root was attempted in 28 patients with an average stimulation threshold of 8.6 ± 0.9 mA. Mapping of the traversing nerve root was attempted in 12 patients with an average stimulation threshold of 6.0 ± 0.8 mA. There were no instances of new postoperative sensorimotor deficits or dysesthesia. These findings persisted through mean and median follow-up of 294 days and 165 days, respectively. No patient required subsequent lumbar surgery. CONCLUSIONS: Our modified instrumentation and technique allow for accurate identification of the exiting and traversing nerve roots with minimal changes to the workflow of transforaminal endoscopic lumbar approaches. Modification of a bipolar radiofrequency device connection arrangement is simple, inexpensive, and reusable. In this study, no patients developed injury or pain related to nerve root dysfunction.

Middle meningeal artery embolization for chronic subdural hematoma: Endovascular technique and radiographic findings.

Background and purpose Embolization of the middle meningeal artery (MMA) has recently been proposed as an alternative to surgery for treatment of chronic subdural hematoma (SDH), and several case reports have been published supporting its efficacy. It has been suggested that the primary pathologic process in chronic SDH is repeated microhemorrhaging into the subdural collection from fragile neovasculature within the SDH membrane that arises from distal branches of the MMA. Embolization could thus provide a means of eliminating this chronic rebleeding. Materials and methods Images were selected from MMA embolization procedures performed at our institution in order to illustrate the technique and theory behind its efficacy for treatment of chronic SDH. Results Images from MMA angiograms demonstrate the variability of MMA anatomy and help illustrate the importance of avoiding potential ophthalmic collaterals and branches supplying cranial nerves. The findings of irregular wispiness of the distal MMA vasculature, contrast outlining of the SDH membrane on angiography, and homogenous increased density within the SDH on postembolization head computed tomography are described. Conclusion MMA embolization may provide a safe alternative for treatment of chronic SDH, but careful angiographic assessment of MMA anatomy should be performed to avoid potential complications. The findings illustrated here lend support to the theory that the pathologic process of chronic SDH is repeated leakage of blood products from an inflamed, abnormal arterial neovasculature within the SDH membrane that arises from the MMA, and thus selective embolization could provide an effective treatment.

Middle Meningeal Artery Embolization as Treatment for Chronic Subdural Hematoma: A Case Series.

BACKGROUND: Traditional treatment for symptomatic subdural hematoma (SDH) has been surgical evacuation, but recurrence rates are high and patients often harbor complex medical comorbidities. Growth and recurrence is thought to be due to the highly friable nature of the vascularized membrane that forms after initial injury. There have been reported cases of middle meningeal artery (MMA) embolization for treatment of recurrent SDH after surgical evacuation with the goal of eliminating the arterial supply to this vascularized membrane. OBJECTIVE: To present the first known case series of MMA embolization as upfront treatment for symptomatic chronic SDHs that have failed conservative management in lieu of surgical evacuation. METHODS: Five patients with symptomatic chronic SDHs underwent MMA embolization using PVA microparticles at our institution. Size of SDH was recorded in maximum diameter and total volume. RESULTS: Four patients underwent unilateral and 1 underwent bilateral MMA embolization successfully. All cases had significant reduction in total volume of SDH at longest follow-up scan: 81.4 to 13.8 cc (7 wk), 48.5 to 8.7 cc (3 wk), 31.7 and 88 to 0 and 17 cc (14 wk, bilateral), 79.3 to 24.2 cc (8 wk), and 53.5 to 0 cc (6 wk). All patients had symptomatic relief with no complications. Histologic analysis of the chronic SDH membrane in a separate patient that required surgery revealed rich neovascularization with many capillaries and few small arterioles. CONCLUSION: MMA embolization could present a minimally invasive and low-risk initial treatment alternative to surgery for symptomatic chronic SDH when clinically appropriate.

Cranial neuropathy due to intradural disc herniation.

BACKGROUND AND IMPORTANCE: Herniated intervertebral disc fragments rarely penetrate the thecal sac, and intracranial hypotension attributable to such penetrating fragments is even more unusual. We describe the first reported case of a cranial neuropathy due to intradural herniation of a disc fragment, in which intracranial hypotension from a resulting cerebrospinal fluid leak caused bilateral abducens palsies. CLINICAL PRESENTATION: A 45-year-old man presented with a positional headache after having experienced a "popping" sensation in his back while lifting a heavy object. He also reported blurred vision and was noted to have lateral gaze palsies bilaterally. Magnetic resonance imaging (MRI) of the brain revealed bilateral subdural collections, abnormal pachymeningeal enhancement, and cerebellar tonsillar herniation, suggesting intracranial hypotension. T2-weighted MRI of the spine revealed extrusion of the T12-L1 disc and suggested the presence of a disc fragment in the intradural space, displacing the caudal nerve roots. A myelogram demonstrated a filling defect extending into the subarachnoid space adjacent to the disc herniation, consistent with a free disc fragment in the intradural space. A diagnosis of intracranial hypotension due to a cerebrospinal fluid leak resulting from an intradural herniated disc was made. The diagnosis was confirmed intraoperatively. CONCLUSION: Surgical removal of the herniated disc fragment and repair of the dural defect resulted in complete resolution of the cranial neuropathy. This rare etiology of a cranial neuropathy, arising from pathology in the thoracolumbar spine, illustrates the clinical teaching that the sixth cranial nerve is highly sensitive to deformation induced by intracranial hypotension.

Third-ventricular neurocysticercosis: hydraulic maneuvers facilitating endoscopic resection.

BACKGROUND: Neurocysticercosis, an infection of the central nervous system with the larval cysts of the pork tapeworm, Taenia solium, is the most common parasitic disease of the central nervous system. The disease is a major global cause of acquired epilepsy and may also manifest as intracranial hypertension due to mass effect from large cysts or to cerebrospinal fluid flow obstruction by intraventricular cysts or inflammation of the subarachnoid space. While the condition is endemic in several regions of the world and has been appreciated as a public health problem in such regions for several decades, its emergence in the USA in areas far from the Mexican border is a more recent phenomenon. METHODS: We present a case of surgically corrected acute hydrocephalus in a recent Haitian emigrant child due to a third ventricular neurocysticercal cyst complex. RESULTS: We describe the endoscope-assisted en bloc removal of the complex, together with hydraulic maneuvers facilitating the removal of the intact cyst. CONCLUSIONS: Simple hydraulic maneuvers can facilitate the endoscopic en bloc removal of third ventricular neurocysticercal cysts.

Real-time brain oscillation detection and phase-locked stimulation using autoregressive spectral estimation and time-series forward prediction.

Neural oscillations are important features in a working central nervous system, facilitating efficient communication across large networks of neurons. They are implicated in a diverse range of processes such as synchronization and synaptic plasticity, and can be seen in a variety of cognitive processes. For example, hippocampal theta oscillations are thought to be a crucial component of memory encoding and retrieval. To better study the role of these oscillations in various cognitive processes, and to be able to build clinical applications around them, accurate and precise estimations of the instantaneous frequency and phase are required. Here, we present methodology based on autoregressive modeling to accomplish this in real time. This allows the targeting of stimulation to a specific phase of a detected oscillation. We first assess performance of the algorithm on two signals where the exact phase and frequency are known. Then, using intracranial EEG recorded from two patients performing a Sternberg memory task, we characterize our algorithm's phase-locking performance on physiologic theta oscillations: optimizing algorithm parameters on the first patient using a genetic algorithm, we carried out cross-validation procedures on subsequent trials and electrodes within the same patient, as well as on data recorded from the second patient.

Efficient universal computing architectures for decoding neural activity.

The ability to decode neural activity into meaningful control signals for prosthetic devices is critical to the development of clinically useful brain- machine interfaces (BMIs). Such systems require input from tens to hundreds of brain-implanted recording electrodes in order to deliver robust and accurate performance; in serving that primary function they should also minimize power dissipation in order to avoid damaging neural tissue; and they should transmit data wirelessly in order to minimize the risk of infection associated with chronic, transcutaneous implants. Electronic architectures for brain- machine interfaces must therefore minimize size and power consumption, while maximizing the ability to compress data to be transmitted over limited-bandwidth wireless channels. Here we present a system of extremely low computational complexity, designed for real-time decoding of neural signals, and suited for highly scalable implantable systems. Our programmable architecture is an explicit implementation of a universal computing machine emulating the dynamics of a network of integrate-and-fire neurons; it requires no arithmetic operations except for counting, and decodes neural signals using only computationally inexpensive logic operations. The simplicity of this architecture does not compromise its ability to compress raw neural data by factors greater than [Formula: see text]. We describe a set of decoding algorithms based on this computational architecture, one designed to operate within an implanted system, minimizing its power consumption and data transmission bandwidth; and a complementary set of algorithms for learning, programming the decoder, and postprocessing the decoded output, designed to operate in an external, nonimplanted unit. The implementation of the implantable portion is estimated to require fewer than 5000 operations per second. A proof-of-concept, 32-channel field-programmable gate array (FPGA) implementation of this portion is consequently energy efficient. We validate the performance of our overall system by decoding electrophysiologic data from a behaving rodent.

A glucose fuel cell for implantable brain-machine interfaces.

We have developed an implantable fuel cell that generates power through glucose oxidation, producing 3.4 µW cm(-2) steady-state power and up to 180 µW cm(-2) peak power. The fuel cell is manufactured using a novel approach, employing semiconductor fabrication techniques, and is therefore well suited for manufacture together with integrated circuits on a single silicon wafer. Thus, it can help enable implantable microelectronic systems with long-lifetime power sources that harvest energy from their surrounds. The fuel reactions are mediated by robust, solid state catalysts. Glucose is oxidized at the nanostructured surface of an activated platinum anode. Oxygen is reduced to water at the surface of a self-assembled network of single-walled carbon nanotubes, embedded in a Nafion film that forms the cathode and is exposed to the biological environment. The catalytic electrodes are separated by a Nafion membrane. The availability of fuel cell reactants, oxygen and glucose, only as a mixture in the physiologic environment, has traditionally posed a design challenge: Net current production requires oxidation and reduction to occur separately and selectively at the anode and cathode, respectively, to prevent electrochemical short circuits. Our fuel cell is configured in a half-open geometry that shields the anode while exposing the cathode, resulting in an oxygen gradient that strongly favors oxygen reduction at the cathode. Glucose reaches the shielded anode by diffusing through the nanotube mesh, which does not catalyze glucose oxidation, and the Nafion layers, which are permeable to small neutral and cationic species. We demonstrate computationally that the natural recirculation of cerebrospinal fluid around the human brain theoretically permits glucose energy harvesting at a rate on the order of at least 1 mW with no adverse physiologic effects. Low-power brain-machine interfaces can thus potentially benefit from having their implanted units powered or recharged by glucose fuel cells.