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2.
Brain ; 2024 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-38195196

RESUMO

In Parkinson's disease, imbalances between "antikinetic" and "prokinetic" patterns of neuronal oscillatory activity are related to motor dysfunction. Invasive brain recordings from the motor network have suggested that medical or surgical therapy can promote a prokinetic state by inducing narrowband gamma rhythms (65-90 Hz). Excessive narrowband gamma in the motor cortex promotes dyskinesia in rodent models, but the relationship between narrowband gamma and dyskinesia in humans has not been well established. To assess this relationship, we used a sensing-enabled deep brain stimulator system, attached to both motor cortex and basal ganglia (subthalamic or pallidal) leads, paired with wearable devices that continuously tracked motor signs in the contralateral upper limbs. We recorded 984 hours of multisite field potentials in 30 hemispheres of 16 subjects with Parkinson's disease (2/16 female, mean age 57 ± 12 years) while at home on usual antiparkinsonian medications. Recordings were done two to four weeks after implantation, prior to starting therapeutic stimulation. Narrowband gamma was detected in the precentral gyrus, subthalamic nucleus, or both structures on at least one side of 92% of subjects with a clinical history of dyskinesia. Narrowband gamma was not detected in the globus pallidus. Narrowband gamma spectral power in both structures co-fluctuated similarly with contralateral wearable dyskinesia scores (mean correlation coefficient of ρ=0.48 with a range of 0.12-0.82 for cortex, ρ=0.53 with a range of 0.5-0.77 for subthalamic nucleus). Stratification analysis showed the correlations were not driven by outlier values, and narrowband gamma could distinguish "on" periods with dyskinesia from "on" periods without dyskinesia. Time lag comparisons confirmed that gamma oscillations herald dyskinesia onset without a time lag in either structure when using 2-minute epochs. A linear model incorporating the three oscillatory bands (beta, theta/alpha, and narrowband gamma) increased the predictive power of dyskinesia for several subject hemispheres. We further identified spectrally distinct oscillations in the low gamma range (40-60 Hz) in three subjects, but the relationship of low gamma oscillations to dyskinesia was variable. Our findings support the hypothesis that excessive oscillatory activity at 65-90 Hz in the motor network tracks with dyskinesia similarly across both structures, without a detectable time lag. This rhythm may serve as a promising control signal for closed-loop deep brain stimulation using either cortical or subthalamic detection.

3.
Brain Stimul ; 16(5): 1412-1424, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37683763

RESUMO

OBJECTIVES: The exact mechanisms of deep brain stimulation (DBS) are still an active area of investigation, in spite of its clinical successes. This is due in part to the lack of understanding of the effects of stimulation on neuronal rhythms. Entrainment of brain oscillations has been hypothesised as a potential mechanism of neuromodulation. A better understanding of entrainment might further inform existing methods of continuous DBS, and help refine algorithms for adaptive methods. The purpose of this study is to develop and test a theoretical framework to predict entrainment of cortical rhythms to DBS across a wide range of stimulation parameters. MATERIALS AND METHODS: We fit a model of interacting neural populations to selected features characterising PD patients' off-stimulation finely-tuned gamma rhythm recorded through electrocorticography. Using the fitted models, we predict basal ganglia DBS parameters that would result in 1:2 entrainment, a special case of sub-harmonic entrainment observed in patients and predicted by theory. RESULTS: We show that the neural circuit models fitted to patient data exhibit 1:2 entrainment when stimulation is provided across a range of stimulation parameters. Furthermore, we verify key features of the region of 1:2 entrainment in the stimulation frequency/amplitude space with follow-up recordings from the same patients, such as the loss of 1:2 entrainment above certain stimulation amplitudes. CONCLUSION: Our results reveal that continuous, constant frequency DBS in patients may lead to nonlinear patterns of neuronal entrainment across stimulation parameters, and that these responses can be predicted by modelling. Should entrainment prove to be an important mechanism of therapeutic stimulation, our modelling framework may reduce the parameter space that clinicians must consider when programming devices for optimal benefit.


Assuntos
Estimulação Encefálica Profunda , Doença de Parkinson , Humanos , Doença de Parkinson/terapia , Estimulação Encefálica Profunda/métodos , Gânglios da Base , Modalidades de Fisioterapia , Eletrocorticografia
4.
Neuromodulation ; 26(3): 614-619, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35715282

RESUMO

OBJECTIVE: The mechanisms of action of high-frequency stimulation (HFS) are unknown. We investigated the possible mechanism of subthreshold superexcitability of HFS on the excitability of the peripheral nerve. MATERIALS AND METHODS: The ulnar nerve was stimulated at the wrist in six healthy participants with a single (control) stimulus, and the responses were compared with the responses to a continuous train of 5 seconds at frequencies of 500 Hz, 2.5 kHz, 5 kHz, and 10 kHz. Threshold intensity for compound muscle action potential (CMAP) was defined as intensity producing a 100-µV amplitude in ten sequential trials and "subthreshold" as 10% below the CMAP threshold. HFS threshold was defined as stimulation intensity eliciting visible tetanic contraction. RESULTS: Comparing the threshold of single pulse stimulation for eliciting CMAP vs threshold for HFS response and pooling data at different frequencies (500 Hz-10 kHz) revealed a significant difference (p = 0.00015). This difference was most obvious at 10 kHz, with a mean value for threshold reduction of 42.2%. CONCLUSIONS: HFS with a stimulation intensity below the threshold for a single pulse induces axonal superexcitability if applied in a train. It can activate the peripheral nerve and produce a tetanic muscle response. Subthreshold superexcitability may allow new insights into the mechanism of HFS.


Assuntos
Axônios , Punho , Humanos , Voluntários Saudáveis , Frequência Cardíaca , Nervos Periféricos
5.
Reprod Domest Anim ; 57 Suppl 5: 90-93, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35699357

RESUMO

The aim was to assess the reproductive efficiency of different techniques used to preserve spermatozoa in artificial insemination semen doses (AI-doses) by evaluating refrigeration at 15°C, cryopreservation and encapsulation. Forty-two hyperprolific sows were treated with buserelin and inseminated once at a single fixed time. The fertility rate, embryonic vesicles viability and the early embryonic mortality (arrested conceptuses) evaluated post-mortem at 24th day of pregnancy, were analysed in order to assess the effectiveness of each proposed technique. Results show an overall reduction on fertility using the three proposal sperm preservation techniques (69.27%, 60.00% and 78.75% for refrigerated, frozen-thawed and encapsulated AI-doses, respectively). Total number of embryonic vesicles was very similar among the three treatments; yet, the number of viable vesicles was numerically different among groups, and thus, embryonic viability was 79.25%, 80.0% and 87.15% for refrigerated, frozen-thawed and encapsulated AI-doses, respectively.


Assuntos
Preservação do Sêmen , Sêmen , Animais , Busserrelina , Criopreservação/veterinária , Feminino , Fertilidade , Inseminação Artificial/métodos , Inseminação Artificial/veterinária , Masculino , Gravidez , Preservação do Sêmen/métodos , Preservação do Sêmen/veterinária , Espermatozoides , Suínos
6.
Front Hum Neurosci ; 16: 813387, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35308605

RESUMO

DBS Think Tank IX was held on August 25-27, 2021 in Orlando FL with US based participants largely in person and overseas participants joining by video conferencing technology. The DBS Think Tank was founded in 2012 and provides an open platform where clinicians, engineers and researchers (from industry and academia) can freely discuss current and emerging deep brain stimulation (DBS) technologies as well as the logistical and ethical issues facing the field. The consensus among the DBS Think Tank IX speakers was that DBS expanded in its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. After collectively sharing our experiences, it was estimated that globally more than 230,000 DBS devices have been implanted for neurological and neuropsychiatric disorders. As such, this year's meeting was focused on advances in the following areas: neuromodulation in Europe, Asia and Australia; cutting-edge technologies, neuroethics, interventional psychiatry, adaptive DBS, neuromodulation for pain, network neuromodulation for epilepsy and neuromodulation for traumatic brain injury.

7.
J Neural Eng ; 19(2)2022 03 31.
Artigo em Inglês | MEDLINE | ID: mdl-35234664

RESUMO

Objective. To provide a design analysis and guidance framework for the implementation of concurrent stimulation and sensing during adaptive deep brain stimulation (aDBS) with particular emphasis on artifact mitigations.Approach. We defined a general architecture of feedback-enabled devices, identified key components in the signal chain which might result in unwanted artifacts and proposed methods that might ultimately enable improved aDBS therapies. We gathered data from research subjects chronically-implanted with an investigational aDBS system, Summit RC + S, to characterize and explore artifact mitigations arising from concurrent stimulation and sensing. We then used a prototype investigational implantable device, DyNeuMo, and a bench-setup that accounts for tissue-electrode properties, to confirm our observations and verify mitigations. The strategies to reduce transient stimulation artifacts and improve performance during aDBS were confirmed in a chronic implant using updated configuration settings.Main results.We derived and validated a 'checklist' of configuration settings to improve system performance and areas for future device improvement. Key considerations for the configuration include (a) active instead of passive recharge, (b) sense-channel blanking in the amplifier, (c) high-pass filter settings, (d) tissue-electrode impedance mismatch management, (e) time-frequency trade-offs in the classifier, (f) algorithm blanking and transition rate limits. Without proper channel configuration, the aDBS algorithm was susceptible to limit-cycles of oscillating stimulation independent of physiological state. By applying the checklist, we could optimize each block's performance characteristics within the overall system. With system-level optimization, a 'fast' aDBS prototype algorithm was demonstrated to be feasible without reentrant loops, and with noise performance suitable for subcortical brain circuits.Significance. We present a framework to study sources and propose mitigations of artifacts in devices that provide chronic aDBS. This work highlights the trade-offs in performance as novel sensing devices translate to the clinic. Finding the appropriate balance of constraints is imperative for successful translation of aDBS therapies.Clinical trial:Institutional Review Board and Investigational Device Exemption numbers: NCT02649166/IRB201501021 (University of Florida), NCT04043403/IRB52548 (Stanford University), NCT03582891/IRB1824454 (University of California San Francisco). IDE #180 097.


Assuntos
Estimulação Encefálica Profunda , Algoritmos , Encéfalo , Estimulação Encefálica Profunda/métodos , Retroalimentação , Humanos
8.
Front Neurosci ; 15: 732499, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34733132

RESUMO

Adaptive deep brain stimulation (aDBS) is a promising new technology with increasing use in experimental trials to treat a diverse array of indications such as movement disorders (Parkinson's disease, essential tremor), psychiatric disorders (depression, OCD), chronic pain and epilepsy. In many aDBS trials, a neural biomarker of interest is compared with a predefined threshold and stimulation amplitude is adjusted accordingly. Across indications and implant locations, potential biomarkers are greatly influenced by sleep. Successful chronic embedded adaptive detectors must incorporate a strategy to account for sleep, to avoid unwanted or unexpected algorithm behavior. Here, we show a dual algorithm design with two independent detectors, one used to track sleep state (wake/sleep) and the other used to track parkinsonian motor state (medication-induced fluctuations). Across six hemispheres (four patients) and 47 days, our detector successfully transitioned to sleep mode while patients were sleeping, and resumed motor state tracking when patients were awake. Designing "sleep aware" aDBS algorithms may prove crucial for deployment of clinically effective fully embedded aDBS algorithms.

9.
Front Hum Neurosci ; 15: 714256, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34322004

RESUMO

Closed-loop neurostimulation is a promising therapy being tested and clinically implemented in a growing number of neurological and psychiatric indications. This therapy is enabled by chronically implanted, bidirectional devices including the Medtronic Summit RC+S system. In order to successfully optimize therapy for patients implanted with these devices, analyses must be conducted offline on the recorded neural data, in order to inform optimal sense and stimulation parameters. The file format, volume, and complexity of raw data from these devices necessitate conversion, parsing, and time reconstruction ahead of time-frequency analyses and modeling common to standard neuroscientific analyses. Here, we provide an open-source toolbox written in Matlab which takes raw files from the Summit RC+S and transforms these data into a standardized format amenable to conventional analyses. Furthermore, we provide a plotting tool which can aid in the visualization of multiple data streams and sense, stimulation, and therapy settings. Finally, we describe an analysis module which replicates RC+S on-board power computations, a functionality which can accelerate biomarker discovery. This toolbox aims to accelerate the research and clinical advances made possible by longitudinal neural recordings and adaptive neurostimulation in people with neurological and psychiatric illnesses.

10.
Exp Neurol ; 345: 113825, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34331900

RESUMO

Dystonia is a disabling movement disorder characterized by excessive muscle contraction for which the underlying pathophysiology is incompletely understood and treatment interventions limited in efficacy. Here we utilize a novel, sensing-enabled, deep brain stimulator device, implanted in a patient with cervical dystonia, to record local field potentials from chronically implanted electrodes in the sensorimotor cortex and subthalamic nuclei bilaterally. This rechargeable device was able to record large volumes of neural data at home, in the naturalistic environment, during unconstrained activity. We confirmed the presence of theta (3-7 Hz) oscillatory activity, which was coherent throughout the cortico-subthalamic circuit and specifically suppressed by high-frequency stimulation. Stimulation also reduced the duration, rate and height of theta bursts. These findings motivated a proof-of-principle trial of a new form of adaptive deep brain stimulation - triggered by theta-burst activity recorded from the motor cortex. This facilitated increased peak stimulation amplitudes without induction of dyskinesias and demonstrated improved blinded clinical ratings compared to continuous DBS, despite reduced total electrical energy delivered. These results further strengthen the pathophysiological role of low frequency (theta) oscillations in dystonia and demonstrate the potential for novel adaptive stimulation strategies linked to cortico-basal theta bursts.


Assuntos
Estimulação Encefálica Profunda/métodos , Neuroestimuladores Implantáveis , Córtex Motor/fisiologia , Ritmo Teta/fisiologia , Torcicolo/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Torcicolo/fisiopatologia
11.
Front Surg ; 6: 58, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31632981

RESUMO

Facial nerve damage has a detrimental effect on a patient's life, therefore safety mechanisms to ensure its preservation are essential during lateral skull base surgery. During robotic cochlear implantation a trajectory passing the facial nerve at <0.5 mm is needed. Recently a stimulation probe and nerve monitoring approach were developed and introduced clinically, however for patient safety no trajectory was drilled closer than 0.4 mm. Here we assess the performance of the nerve monitoring system at closer distances. In a sheep model eight trajectories were drilled to test the setup followed by 12 trajectories during which the ENT surgeon relied solely on the nerve monitoring system and aborted the robotic drilling process if intraoperative nerve monitoring alerted of a distance <0.1 mm. Microcomputed tomography images and histopathology showed prospective use of the technology prevented facial nerve damage. Facial nerve monitoring integrated in a robotic system supports the surgeon's ability to proactively avoid damage to the facial nerve during robotic drilling in the mastoid.

12.
PLoS One ; 14(8): e0220543, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31374092

RESUMO

To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.


Assuntos
Cóclea/cirurgia , Implante Coclear/métodos , Implantes Cocleares , Perda Auditiva/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Adulto , Idoso , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
13.
Eur Arch Otorhinolaryngol ; 276(5): 1283-1289, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30739180

RESUMO

PURPOSE: A recent clinical trial has shown the feasibility of robotic cochlear implantation. The electrode was inserted through the robotically drilled tunnel and an additional access through the external auditory canal was created to provide for means of visualization and manipulation. To obviate the need for this additional access, the utilization of multiple robotically drilled tunnels targeting the round window has been proposed. The objective of this study was to assess the feasibility of electrode insertion through a robotic multiport approach. METHODS: In four ex vivo human head specimens (left side), four trajectories through the facial recess (2x) and the retrofacial and suprameatal region were planned and robotically drilled. Optimal three-port configurations were determined for each specimen by analyzing combinations of three of the four trajectories, where the three trajectories were used for the electrode, endoscopic visualization and manipulative assistance. Finally, electrode insertions were conducted through the optimal configurations. RESULTS: The electrodes could successfully be inserted, and the procedure sufficiently visualized through the facial recess drill tunnels in all specimens. Effective manipulative assistance for sealing the round window could be provided through the retrofacial tunnel. CONCLUSIONS: Electrode insertion through a robotic three-port approach is feasible. Drill tunnels through the facial recess for the electrode and endoscope allow for optimized insertion angles and sufficient visualization. Through a retrofacial tunnel effective manipulation for sealing is possible.


Assuntos
Implante Coclear/métodos , Implantes Cocleares , Procedimentos Cirúrgicos Robóticos/métodos , Janela da Cóclea/cirurgia , Meato Acústico Externo/cirurgia , Estudos de Viabilidade , Humanos , Técnicas In Vitro
14.
IEEE Trans Biomed Eng ; 66(1): 237-245, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29993441

RESUMO

Reported studies pertaining to needle guidance suggest that tissue impedance available from neuromonitoring systems can be used to discriminate nerve tissue proximity. In this pilot study, the existence of a relationship between intraoperative electrical impedance and tissue density, estimated from computer tomography (CT) images, is evaluated in the mastoid bone of in vivo sheep. In five subjects, nine trajectories were drilled using an image-guided surgical robot. Per trajectory, five measurement points near the facial nerve were accessed and electrical impedance was measured (≤1 KHz) using a multipolar electrode probe. Micro-CT was used postoperatively to measure the distances from the drilled trajectories to the facial nerve. Tissue density was determined from coregistered preoperative CT images and, following sensitivity field modeling of the measuring tip, tissue resistivity was calculated. The relationship between impedance and density was determined for 29 trajectories passing or intersecting the facial nerve. A monotonic decrease in impedance magnitude was observed in all trajectories with a drill axis intersecting the facial nerve. Mean tissue densities intersecting with the facial nerve (971-1161 HU) were different (p <0.01) from those along safe trajectories passing the nerve (1194-1449 HU). However, mean resistivity values of trajectories intersecting the facial nerve (14-24 Ωm) were similar to those of safe passing trajectories (17-23 Ωm). The determined relationship between tissue density and electrical impedance during neuromonitoring of the facial nerve suggests that impedance spectroscopy may be used to increase the accuracy of tissue discrimination, and ultimately improve nerve safety distance assessment in the future.


Assuntos
Implante Coclear/métodos , Impedância Elétrica/uso terapêutico , Nervo Facial/fisiologia , Procedimentos Cirúrgicos Robóticos/métodos , Animais , Traumatismos do Nervo Facial/prevenção & controle , Humanos , Ovinos
15.
Otol Neurotol ; 39(10): 1326-1335, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30239434

RESUMO

HYPOTHESIS: Combining novel registration strategies and advanced image guidance technology enable submillimeter accurate and noninvasive navigation for middle ear and lateral skull base surgery. BACKGROUND: Surgery in the internal auditory canal and the petrous apex present a cognitive and motoric challenge for the surgeon. To date, image guidance rarely assists these procedures, mainly due to the lack of navigation solutions providing submillimeter accuracy associated with low cost in terms of invasiveness, radiation, and time. METHODS: This study proposes an approach to clinically viable image guidance by using a combination of advanced image guidance technology and noninvasive registration strategies. Based on accuracy-optimized optical tracking hardware (accuracy: 0.05 ±â€Š0.025 mm), 14 novel registration strategies were investigated. In human cadaveric temporal bone specimens n = 36 registration attempts per strategy were conducted. Target registration errors at 10 anatomical targets were measured. RESULTS: The most accurate registration strategies were identified as paired-point-matching using eight landmarks located in the external auditory canal and middle ear and surface matching using combined surfaces of the middle ear, the external auditory canal and the mastoid cortex yielding target registration errors of 0.51 ±â€Š0.28 mm and 0.36 ±â€Š0.13 mm respectively. CONCLUSIONS: This study demonstrates submillimeter TREs achieved with noninvasive, anatomy-based registration strategies in combination with advanced image guidance technology. Clinically viable LSB and ME navigation is realized without additional invasiveness, radiation and time associated with artificial fiducials. The appropriate registration strategy can be chosen by the surgeon depending on the pathology and surgical approach.


Assuntos
Procedimentos Neurocirúrgicos/métodos , Procedimentos Cirúrgicos Otológicos/métodos , Base do Crânio/cirurgia , Cirurgia Assistida por Computador/métodos , Pontos de Referência Anatômicos , Meato Acústico Externo/diagnóstico por imagem , Meato Acústico Externo/cirurgia , Orelha Média/diagnóstico por imagem , Orelha Média/cirurgia , Humanos , Osso Petroso/diagnóstico por imagem , Osso Petroso/cirurgia , Reprodutibilidade dos Testes , Base do Crânio/anatomia & histologia , Tomografia Computadorizada por Raios X
16.
Ann Biomed Eng ; 46(10): 1568-1581, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30051248

RESUMO

During robotic cochlear implantation a drill trajectory often passes at submillimeter distances from the facial nerve due to close lying critical anatomy of the temporal bone. Additional intraoperative safety mechanisms are thus required to ensure preservation of this vital structure in case of unexpected navigation system error. Electromyography based nerve monitoring is widely used to aid surgeons in localizing vital nerve structures at risk of injury during surgery. However, state of the art neuromonitoring systems, are unable to discriminate facial nerve proximity within submillimeter ranges. Previous work demonstrated the feasibility of utilizing combinations of monopolar and bipolar stimulation threshold measurements to discretize facial nerve proximity with greater sensitivity and specificity, enabling discrimination between safe (> 0.4 mm) and unsafe (< 0.1 mm) trajectories during robotic cochlear implantation (in vivo animal model). Herein, initial clinical validation of the determined stimulation protocol and nerve proximity analysis integrated into an image guided system for safety measurement is presented. Stimulation thresholds and corresponding nerve proximity values previously determined from an animal model have been validated in a first-in-man clinical trial of robotic cochlear implantation. Measurements performed automatically at preoperatively defined distances from the facial nerve were used to determine safety of the drill trajectory intraoperatively. The presented system and automated analysis correctly determined sufficient safety distance margins (> 0.4 mm) to the facial nerve in all cases.


Assuntos
Implante Coclear , Implantes Cocleares , Eletromiografia , Procedimentos Cirúrgicos Robóticos , Adulto , Implante Coclear/instrumentação , Implante Coclear/métodos , Eletromiografia/instrumentação , Eletromiografia/mortalidade , Feminino , Humanos , Masculino , Monitorização Fisiológica/instrumentação , Monitorização Fisiológica/métodos , Procedimentos Cirúrgicos Robóticos/instrumentação , Procedimentos Cirúrgicos Robóticos/métodos
17.
Acta Otolaryngol ; 137(4): 447-454, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28145157

RESUMO

CONCLUSION: A system for robotic cochlear implantation (rCI) has been developed and a corresponding surgical workflow has been described. The clinical feasibility was demonstrated through the conduction of a safe and effective rCI procedure. OBJECTIVES: To define a clinical workflow for rCI and demonstrate its feasibility, safety, and effectiveness within a clinical setting. METHOD: A clinical workflow for use of a previously described image guided surgical robot system for rCI was developed. Based on pre-operative images, a safe drilling tunnel targeting the round window was planned and drilled by the robotic system. Intra-operatively the drill path was assessed using imaging and sensor-based data to confirm the proximity of the facial nerve. Electrode array insertion was manually achieved under microscope visualization. Electrode array placement, structure preservation, and the accuracy of the drilling and of the safety mechanisms were assessed on post-operative CT images. RESULTS: Robotic drilling was conducted with an accuracy of 0.2 mm and safety mechanisms predicted proximity of the nerves to within 0.1 mm. The approach resulted in a minimal mastoidectomy and minimal incisions. Manual electrode array insertion was successfully performed through the robotically drilled tunnel. The procedure was performed without complications, and all surrounding structures were preserved.


Assuntos
Implante Coclear/métodos , Robótica , Estudos de Viabilidade , Humanos , Tomografia Computadorizada por Raios X , Fluxo de Trabalho
18.
Ann Biomed Eng ; 45(4): 1122-1132, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-27830489

RESUMO

Nerve monitoring is a safety mechanism to detect the proximity between surgical instruments and important nerves during surgical bone preparation. In temporal bone, this technique is highly specific and sensitive at distances below 0.1 mm, but remains unreliable for distances above this threshold. A deeper understanding of the patient-specific bone electric properties is required to improve this range of detection. A sheep animal model has been used to characterize bone properties in vivo. Impedance measurements have been performed at low frequencies (<1 kHz) between two electrodes placed inside holes drilled into the sheep mastoid bone. An electric circuit composed of a resistor and a Fricke constant phase element was able to accurately describe the experimental measurements. Bone resistivity was shown to be linearly dependent on the inter-electrode distance and the local bone density. Based on this model, the amount of bone material between the electrodes could be predicted with an error of 0.7 mm. Our results indicate that bone could be described as an ideal resistor while the electrochemical processes at the electrode-tissue interface are characterized by a constant phase element. These results should help increasing the safety of surgical drilling procedures by better predicting the distance to critical nerve structures.


Assuntos
Impedância Elétrica , Processo Mastoide/química , Animais , Processo Mastoide/metabolismo , Ovinos
20.
Ann Biomed Eng ; 44(5): 1576-86, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26358479

RESUMO

Surgical robots have been proposed ex vivo to drill precise holes in the temporal bone for minimally invasive cochlear implantation. The main risk of the procedure is damage of the facial nerve due to mechanical interaction or due to temperature elevation during the drilling process. To evaluate the thermal risk of the drilling process, a simplified model is proposed which aims to enable an assessment of risk posed to the facial nerve for a given set of constant process parameters for different mastoid bone densities. The model uses the bone density distribution along the drilling trajectory in the mastoid bone to calculate a time dependent heat production function at the tip of the drill bit. Using a time dependent moving point source Green's function, the heat equation can be solved at a certain point in space so that the resulting temperatures can be calculated over time. The model was calibrated and initially verified with in vivo temperature data. The data was collected in minimally invasive robotic drilling of 12 holes in four different sheep. The sheep were anesthetized and the temperature elevations were measured with a thermocouple which was inserted in a previously drilled hole next to the planned drilling trajectory. Bone density distributions were extracted from pre-operative CT data by averaging Hounsfield values over the drill bit diameter. Post-operative [Formula: see text]CT data was used to verify the drilling accuracy of the trajectories. The comparison of measured and calculated temperatures shows a very good match for both heating and cooling phases. The average prediction error of the maximum temperature was less than 0.7 °C and the average root mean square error was approximately 0.5 °C. To analyze potential thermal damage, the model was used to calculate temperature profiles and cumulative equivalent minutes at 43 °C at a minimal distance to the facial nerve. For the selected drilling parameters, temperature elevation profiles and cumulative equivalent minutes suggest that thermal elevation of this minimally invasive cochlear implantation surgery may pose a risk to the facial nerve, especially in sclerotic or high density mastoid bones. Optimized drilling parameters need to be evaluated and the model could be used for future risk evaluation.


Assuntos
Densidade Óssea , Cóclea , Implante Coclear , Implantes Cocleares , Processo Mastoide , Procedimentos Cirúrgicos Minimamente Invasivos , Modelos Biológicos , Procedimentos Cirúrgicos Robóticos , Animais , Ovinos , Temperatura
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