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1.
Eur Arch Otorhinolaryngol ; 280(10): 4371-4379, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37010602

RESUMO

PURPOSE: Minimally invasive cochlear implant surgery using a micro-stereotactic surgical targeting system with on-site moulding of the template aims for a reliable, less experience-dependent access to the inner ear under maximal reduction of trauma to anatomic structures. We present an accuracy evaluation of our system in ex-vivo testing. METHODS: Eleven drilling experiments were performed on four cadaveric temporal bone specimens. The process involved preoperative imaging after affixing the reference frame to the skull, planning of a safe trajectory preserving relevant anatomical structures, customization of the surgical template, execution of the guided drilling and postoperative imaging for determination of the drilling accuracy. Deviation between the drilled and desired trajectories was measured at different depths. RESULTS: All drilling experiments were successfully performed. Other than purposely sacrificing the chorda tympani in one experiment, no other relevant anatomy, such as facial nerve, chorda tympani, ossicles or external auditory canal were harmed. Deviation between the desired and achieved path was found to be 0.25 ± 0.16 mm at skulls' surface and 0.51 ± 0.35 mm at the target level. The closest distance of the drilled trajectories' outer circumference to the facial nerve was 0.44 mm. CONCLUSIONS: We demonstrated the usability for drilling to the middle ear on human cadaveric specimen in a pre-clinical setting. Accuracy proved to be suitable for many applications such as procedures within the field of image-guided neurosurgery. Promising approaches to reach sufficient submillimetre accuracy for CI surgery have been outlined.


Assuntos
Implante Coclear , Implantes Cocleares , Cirurgia Assistida por Computador , Humanos , Cirurgia Assistida por Computador/métodos , Implante Coclear/métodos , Osso Temporal/diagnóstico por imagem , Osso Temporal/cirurgia , Cadáver
2.
Ear Hear ; 42(4): 1034-1041, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33480625

RESUMO

OBJECTIVES: (1) To assess variations of the human intracochlear anatomy and quantify factors which might be relevant for cochlear implantation (CI) regarding surgical technique and electrode design. (2) Search for correlations of these factors with clinically assessable measurements. DESIGN: Human temporal bone study with micro computed tomography (µCT) data and analysis of intracochlear geometrical variations: µCT data of 15 fresh human temporal bones was generated, and the intracochlear lumina scala tympani (ST) and scala vestibuli were manually segmented using custom software specifically designed for accurate cochlear segmentation. The corresponding datasets were processed yielding 15 detailed, three-dimensional cochlear models which were investigated in terms of the scalae height, cross-sectional size, and rotation as well as the interrelation of these factors and correlations to others. RESULTS: The greatest anatomical variability was observed within the round window region of the cochlea (basal 45°), especially regarding the cross-sectional size of the ST and its orientation relative to the scala vestibuli, which were found to be correlated (p < 0.001). The cross-sectional height of the ST changes substantially for both increasing cochlear angles and lateral wall distances. Even small cochleae were found to contain enough space for all commercially available CI arrays. Significant correlations of individual intracochlear parameters to clinically assessable ones were found despite the small sample size. CONCLUSION: While there is generally enough space within the ST for CI, strong intracochlear anatomical variations could be observed highlighting the relevance of both soft surgical technique as well as a highly flexible and self-adapting cochlear implant electrode array design. Cochlear dimensions (especially at the round window) could potentially be used to indicate surgically challenging anatomies.


Assuntos
Implante Coclear , Implantes Cocleares , Cóclea/diagnóstico por imagem , Cóclea/cirurgia , Estudos Transversais , Humanos , Rampa do Tímpano/diagnóstico por imagem , Osso Temporal/diagnóstico por imagem , Microtomografia por Raio-X
3.
Int J Audiol ; 59(7): 534-547, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32091289

RESUMO

Objective: Statistical knowledge about many patients could be exploited using machine learning to provide supporting information to otolaryngologists and other hearing health care professionals, but needs to be made accessible. The Common Audiological Functional Parameters (CAFPAs) were recently introduced for the purpose of integrating data from different databases by providing an abstract representation of audiological measurements. This paper aims at collecting expert labels for a sample database and to determine statistical models from the labelled data set.Design: By an expert survey, CAFPAs as well as labels for audiological findings and treatment recommendations were collected for patients from the database of Hörzentrum Oldenburg.Study sample: A total of 287 single patient cases were assessed by twelve highly experienced audiological experts.Results: The labelled data set was used to derive probability density functions for categories given by the expert labels. The collected data set is suitable for estimating training distributions due to realistic variability contained in data for different, distinct categories. Suitable distribution functions were determined. The derived training distributions were compared regarding different audiological questions.Conclusions: The method-expert survey, sorting data into categories, and determining training distributions - could be extended to other data sets, which could then be integrated via the CAFPAs and used in a classification task.


Assuntos
Audiologia/estatística & dados numéricos , Correção de Deficiência Auditiva/estatística & dados numéricos , Conjuntos de Dados como Assunto , Sistemas Inteligentes , Modelos Estatísticos , Interpretação Estatística de Dados , Bases de Dados Factuais , Testes Auditivos/estatística & dados numéricos , Humanos , Probabilidade , Reprodutibilidade dos Testes
4.
Int J Audiol ; 58(4): 231-245, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30900518

RESUMO

OBJECTIVE: As a step towards objectifying audiological rehabilitation and providing comparability between different test batteries and clinics, the Common Audiological Functional Parameters (CAFPAs) were introduced as a common and abstract representation of audiological knowledge obtained from diagnostic tests. DESIGN: Relationships between CAFPAs as an intermediate representation between diagnostic tests and audiological findings, diagnoses and treatment recommendations (summarised as "diagnostic cases") were established by means of an expert survey. Expert knowledge was collected for 14 given categories covering different diagnostic cases. For each case, the experts were asked to indicate expected ranges of diagnostic test outcomes, as well as traffic light-encoded CAFPAs. STUDY SAMPLE: Eleven German experts in the field of audiological rehabilitation from Hanover and Oldenburg participated in the survey. RESULTS: Audiological findings or treatment recommendations could be distinguished by a statistical model derived from the experts' answers for CAFPAs as well as audiological tests. CONCLUSIONS: The CAFPAs serve as an abstract, comprehensive representation of audiological knowledge. If more detailed information on certain functional aspects of the auditory system is required, the CAFPAs indicate which information is missing. The statistical graphical representations for CAFPAs and audiological tests are suitable for audiological teaching material; they are universally applicable for real clinical databases.


Assuntos
Audiologia/estatística & dados numéricos , Correção de Deficiência Auditiva/estatística & dados numéricos , Sistemas Inteligentes , Transtornos da Audição/diagnóstico , Testes Auditivos/estatística & dados numéricos , Aprendizado de Máquina , Interpretação Estatística de Dados , Transtornos da Audição/classificação , Transtornos da Audição/terapia , Humanos , Valor Preditivo dos Testes , Probabilidade , Reprodutibilidade dos Testes
5.
Eur Arch Otorhinolaryngol ; 275(12): 2947-2956, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30302574

RESUMO

PURPOSE: Latest research on cochlear implantations focuses on hearing preservation during insertion of the implant's electrode array by reducing insertion trauma. One parameter which may influence trauma is insertion speed. The objective of this study was to extend the range of examined insertion speeds to include ultra-low velocities, being lower than manually feasible, and investigate whether these reduce insertion forces. METHODS: 24 custom-made cochlear implant test samples were fabricated and inserted into an artificial scala tympani model using 12 different insertion speeds while measuring the resulting insertion forces. Three commercially available slim straight electrode carriers were inserted using the same setup to analyze whether the results are comparable. RESULTS: Insertions of the test samples using high insertion speeds (2.0/2.8 mm/s) showed significantly higher insertion forces than insertions done with low insertion speeds (0.2 mm/s) or ultra-low insertion speeds (< 0.1 mm/s). The insertions with commercial slim straight electrode arrays showed significantly reduced insertion forces when using a low insertion speed as well. CONCLUSIONS: Slow insertions showed significantly reduced insertion forces. Insertion speeds which are lower than manually feasible showed even lower insertion forces.


Assuntos
Implante Coclear/métodos , Implantes Cocleares , Humanos , Modelos Anatômicos
6.
Eur Arch Otorhinolaryngol ; 275(5): 1077-1085, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29532169

RESUMO

PURPOSE: Patient specific selection of cochlear implants would benefit from pre-operative knowledge of cochlear length. Several methods for its measurement or estimation have been described in literature. This study focused on the achievable accuracy in clinically available imaging. METHODS: Five simplified cochlea models milled into porcine bone were scanned in water using clinical cone beam computed tomography. Due to their well-known dimensions these phantoms served as gold standard for the length measurements. Each phantom was measured ten times using the custom software Comet. In addition, cochleae in ten image datasets taken indiscriminately from clinical routine were measured ten times each to test the precision under realistic conditions. The results were also compared to estimations based on the diameter of the basal turn (A value) as described in literature. RESULTS: Measurement accuracy of the phantoms' lengths was high (average error: - 0.2 mm; standard deviation: 0.3 mm). The pooled standard deviation for the measurements in clinical datasets was 0.6 mm. Errors resulted mainly from problems locating the helicotrema. The estimations differed on average - 1.7 to + 0.4 mm from the manual measurements and had standard deviations between 0.5 and 0.6 mm depending on the algorithm. CONCLUSIONS: The program Comet was successfully used to accurately measure the length of the cochlea models in clinically available imaging. The lower image quality of patient scans reduced the precision of the measurement. Estimations using the A value are a quicker alternative for averagely sized cochleae in cases where the lack of accuracy is tolerable.


Assuntos
Ducto Coclear/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Animais , Ducto Coclear/anatomia & histologia , Implante Coclear/instrumentação , Implantes Cocleares , Humanos , Modelos Anatômicos , Imagens de Fantasmas , Software , Suínos
7.
Eur Arch Otorhinolaryngol ; 274(8): 3049-3056, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28589320

RESUMO

This study was conducted to evaluate the effect of the round window membrane accessibility on the residual hearing after cochlear implantation surgery in adults. Moreover, the effects of the other demographics and intra-operative factors on the residual hearing loss have been evaluated. The hearing preservation cochlear implantation surgery was performed on 64 adults with residual hearing thresholds ≤80 dB at 250 and 500 Hz, who had referred to our tertiary academic center. All the patients underwent a standardized surgical approach with the same straight electrode inserted through the round window membrane. The hearing thresholds at 250, 500, and 1000 Hz were compared in pre-operative and 1 month postoperative pure-tone audiograms. The average hearing threshold shifts at these frequencies was used to evaluate the hearing preservation. The effects of the round window accessibility and other factors (including gender, age, side of the surgery, necessity of anterior-inferior drilling of the round window margin and average insertion speed) on hearing threshold shifts were analyzed. The mean low-frequency hearing threshold shift was found to be 17.5 dB for all the patients. The hearing preservation goal (threshold shifts ≤30 dB) was achieved in 58 patients. Among the evaluated parameters, only accessibility of the round window membrane could change the hearing threshold shifts significantly (p = 0.026), and was a predictor for the hearing loss (B coefficient = 7.5, p = 0.006). Incomplete accessibility of the round window membrane may be a predictor for increased hearing threshold shifts in short-term evaluations after cochlear implantation.


Assuntos
Implante Coclear , Perda Auditiva , Complicações Intraoperatórias/etiologia , Complicações Pós-Operatórias , Janela da Cóclea/cirurgia , Adulto , Fatores Etários , Audiometria de Tons Puros/métodos , Implante Coclear/efeitos adversos , Implante Coclear/métodos , Implantes Cocleares , Feminino , Perda Auditiva/diagnóstico , Perda Auditiva/etiologia , Perda Auditiva/prevenção & controle , Humanos , Irã (Geográfico) , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Fatores de Risco , Fatores Sexuais
8.
Eur Arch Otorhinolaryngol ; 274(5): 2131-2140, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28238160

RESUMO

The aim of the study was to evaluate insertion forces during manual insertion of a straight atraumatic electrode in human temporal bones, and post-implantation histologic evaluation of the samples to determine whether violation of intracochlear structures is related to insertion forces. In order to minimize intracochlear trauma and preserve residual hearing during cochlear implantation, knowledge of the insertion forces is necessary. Ten fresh frozen human temporal bones were prepared with canal wall down mastoidectomy. All samples were mounted on a one-axis force sensor. Insertion of a 16-mm straight atraumatic electrode was performed from different angles to induce "traumatic" insertion. Histologic evaluation was performed in order to evaluate intracochlear trauma. In 4 of 10 samples, dislocation of the electrode into scala vestibuli was observed. The mean insertion force for all 10 procedures was 0.003 ± 0.005 N. Insertion forces measured around the site of dislocation to scala vestibuli in 3 of 4 samples were significantly higher than insertion forces at the same location of the cochleae measured in samples without trauma (p < 0.04). Mean force during the whole insertion process of the straight atraumatic electrode is lower than reported by other studies using longer electrodes. Based on our study, insertion forces leading to basilar membrane trauma may be lower than the previously reported direct rupture forces.


Assuntos
Membrana Basilar , Implante Coclear , Implantes Cocleares/efeitos adversos , Complicações Intraoperatórias , Osso Temporal , Membrana Basilar/lesões , Membrana Basilar/patologia , Implante Coclear/efeitos adversos , Implante Coclear/métodos , Humanos , Complicações Intraoperatórias/patologia , Complicações Intraoperatórias/prevenção & controle , Modelos Anatômicos , Ruptura/etiologia , Ruptura/patologia , Ruptura/prevenção & controle , Osso Temporal/patologia , Osso Temporal/cirurgia
9.
Eur Arch Otorhinolaryngol ; 274(3): 1397-1403, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27909890

RESUMO

The objective is to investigate whether there is a correlation between the severity of typical brain lesions in congenital cytomegalovirus (cCMV) infection and cochlear implant (CI) outcome. The design of the study is a retrospective single-institutional chart review (2005-2015), performed in a tertiary academic referral center. 23 children with typical signs of cCMV infection on cerebral magnetic resonance imaging (MRI) and bilateral severe-to-profound sensorineural hearing loss were retrospectively evaluated. They were graded in three groups according to the severity of brain involvement. The average implantation age of the first CI is 1.8 years (range 0.6-5.8). Five patients were implanted unilaterally, 18 bilaterally. The average follow-up time after implantation was 3.3 years (range 0.6-6.9). Hearing performance was assessed using the Categories of Auditory Performance (CAP), and speech development was assessed using Speech Intelligibility Rating (SIR). The outcome in each group showed great variation. The majority of children achieved moderate-to-good auditory and speech rehabilitation. The children with severe MRI changes had comparatively better auditory than speech scores. There were children with good auditory performance (CAP ≥6) both in grades II and III, while poor performers (CAP ≤3) were encountered in each group. The severity of brain lesions on its own does not directly correlate with the outcome of cochlear implantation. Despite good retrospective diagnostic evidence of cCMV infection through MRI patterns, this has no predictive role for future hearing and speech rehabilitation.


Assuntos
Encéfalo/diagnóstico por imagem , Implantes Cocleares , Infecções por Citomegalovirus/complicações , Imageamento por Ressonância Magnética , Índice de Gravidade de Doença , Criança , Pré-Escolar , Feminino , Seguimentos , Perda Auditiva Neurossensorial/cirurgia , Perda Auditiva Neurossensorial/virologia , Testes Auditivos , Humanos , Lactente , Masculino , Polimicrogiria/diagnóstico por imagem , Estudos Retrospectivos , Inteligibilidade da Fala
10.
Biomed Microdevices ; 18(2): 36, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27032960

RESUMO

Within the field of hearing prosthetics it is known that patients with sufficient residual hearing benefit from the simultaneous employment of hearing aid and cochlear implant. Several attempts have been proposed to combine the sources of the corresponding acoustic and electric stimuli in a single, implantable device. However, since only little is known about the effect of also applying the acoustic stimulus locally from within the inner ear, the current state of research lacks detailed knowledge on the optimal stimulation at the corresponding bionic interface. Within this manuscript, a simple but yet physiologically-based inner ear model is presented which was designed specifically for the analysis of local acoustic or mechanical inner ear stimulation. A detailed model analysis is performed showing that it is capable of mirroring the known mechanical phenomena of this particular stimulation approach. Using the model, it is demonstrated how amplitude and phase shift values of stimuli applied from within the inner ear should be chosen for optimal inner ear stimulation.


Assuntos
Cóclea/fisiologia , Fenômenos Mecânicos , Modelos Biológicos , Acústica , Fenômenos Biomecânicos , Próteses Neurais
11.
Eur Arch Otorhinolaryngol ; 273(11): 3641-3646, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27015665

RESUMO

The objective of the study was to examine the impact of the surgical wound closure technique as protection of the obliterated tympanomastoid cavity on the revision surgery rate after subtotal petrosectomy (SP). This is a retrospective case series conducted in a tertiary care referral center. 199 patients (212 ears) with recurrent chronic otitis media underwent SP followed by tympanomastoid obliteration with abdominal fat at a single tertiary referral center between 2005 and 2015. 124 SP were carried out without (group A), 74 with temporalis muscle flap (group B) and 14 with reinforcing material like polydioxanone foil or bovine pericardium or allogenic fascia lata (group C) for wound closure. The evaluated follow-up was either until the scheduled device implantation or 6 months postoperatively. We assessed the rate of postoperative wound healing disorder with revision surgery according to the surgical technique for closure of the obliterated cleft. Revision surgery due to impaired wound healing was necessary in 16 % of the total cases (group A: 18.5 %, group B: 10.8 %, group C: 21.4 %). Further analysis concerning the dehiscent area in both sites (retroauricular and blind sac of the external auditory canal) was conducted and discussed. There was no significant difference observed in the rate of revision surgery between the three groups. The wound healing process after SP is determined by many factors and cannot be significantly influenced solely by reinforcing tissue like the temporalis muscle flap or supporting materials.


Assuntos
Otite Média/cirurgia , Procedimentos Cirúrgicos Otológicos , Técnicas de Fechamento de Ferimentos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Animais , Bovinos , Criança , Doença Crônica , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Ferida Cirúrgica , Resultado do Tratamento , Cicatrização , Adulto Jovem
12.
Eur Arch Otorhinolaryngol ; 273(11): 3573-3585, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26961519

RESUMO

The integration of a shape memory actuator is a potential mechanism to achieve a consistent perimodiolar position after electrode insertion during cochlear implant surgery. After warming up, and therefore activation of the shape memory effect, the electrode array will change from a straight configuration into a spiral shaped one leading to a final position close to the modiolus. The aim of this study was to investigate whether the integration of an additional thin wire (referred to as an "inlay") made of Nitinol, a well-established shape memory alloy, in a conventional hearing preservation electrode array will affect the insertion behaviour in terms of increased risk of insertion trauma. Six conventional Hybrid-L electrode arrays (Cochlear Ltd., Sydney, Australia) were modified to incorporate a wire inlay made of Nitinol. The diameter of the wires was 100 µm with a tapered tip region. Electrodes were inserted into human temporal bone specimens using a standard surgical approach. After insertion and embedding in epoxy resin, histological sections were prepared to evaluate insertion trauma. Insertion was straightforward and no difficulties were observed. The addition of a shape memory wire, thin but also strong enough to curl the electrode array, does not result in histologically detectable insertion trauma. Atraumatic insertion seems possible.


Assuntos
Ligas , Implante Coclear/métodos , Implantes Cocleares , Osso Temporal/cirurgia , Cadáver , Implante Coclear/efeitos adversos , Humanos , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/prevenção & controle , Desenho de Prótese
13.
Audiol Neurootol ; 19(5): 293-309, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25277083

RESUMO

OBJECTIVES: In recent years, it has been possible to preserve hearing after cochlear implantation in patients with significant amounts of low-frequency residual hearing. Due to the dimensions and characteristics of the cochlear implants (CIs) Nucleus® Hybrid™-L24 and Nucleus Freedom™ CI422, both can be used to preserve residual hearing. The aim was to investigate the degree and progression of hearing preservation over a longitudinal postoperative period in a large consecutive cohort of implanted patients with preoperative residual hearing who received either the Nucleus Hybrid-L24 or the Nucleus Freedom CI422 implant. The intention was to examine potential characteristics and triggers of resulting postoperative hearing loss which may support a differentiation of CI candidacy criteria for a certain implant type. METHODS: A retrospective data analysis of patient files on consecutively implanted subjects presenting with a severe-to-profound sensorineural hearing loss at frequencies>1,500 Hz and substantial residual hearing at frequencies≤1,500 Hz, implanted with a Nucleus Hybrid-L24 (n=97) or a CI422 implant (n=100), was undertaken. A single-subject repeated-measure design comparing the mean threshold shift for pure-tone thresholds under headphones up to 24 months after implantation was used. RESULTS: Hearing preservation is observed in the majority of subjects with either implant (250-1,500 Hz frequency range). Hybrid-L24 patients exhibited a median hearing loss of 10 dB at initial fitting (n=97) and of 15 dB after 24 months (n=51). A 14.4-dB decrease in median hearing loss at initial fitting (n=100) and a 30-dB decrease after 24 months (n=28) was observed with the CI422 electrode. At initial fitting, 54.6% of the Hybrid-L24 (n=97) and 49.0% of the CI422 (n=100) subjects showed a mean threshold shift<15 dB. After 24 months, 58.8% (Hybrid-L24, n=51) and 28.6% (CI422, n=28) of the patients showed a mean threshold shift<15 dB. CONCLUSIONS: The results indicate that residual hearing was preserved for the majority of implanted patients with the Hybrid-L24 and the CI422 implant. Patients implanted with the Hybrid-L24 implant demonstrate greater stability and less median hearing loss over time than those with the CI422 implant. Assessments of onset and stability of hearing loss prior to implantation are important factors to consider during candidacy evaluation for electrode selection to potentially maximize the performance outcome for each patient.


Assuntos
Limiar Auditivo , Implante Coclear , Implantes Cocleares , Perda Auditiva Neurossensorial/cirurgia , Audiometria de Tons Puros , Eletrodos Implantados , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
14.
J Otolaryngol Head Neck Surg ; 53: 19160216241248669, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38903014

RESUMO

BACKGROUND: Minimally invasive cochlear implant surgery by using a microstereotactic frame demands solid connection to the bone. We aimed to determine the stability of commercially available orthodontic miniscrews to evaluate their feasibility for frame's fixation. In addition, which substitute material most closely resembles the mechanical properties of the human temporal bone was evaluated. METHODS: Pull-out tests were carried out with five different types of orthodontic miniscrews in human temporal bone specimens. Furthermore, short fiber filled epoxy (SFFE), solid rigid polyurethane (SRPU50), bovine femur, and porcine iliac bone were evaluated as substitute materials. In total, 57 tests in human specimens and 180 tests in the substitute materials were performed. RESULTS: In human temporal bone, average pull-out forces ranged from 220 N to 285 N between screws. Joint stiffness in human temporal bone ranged between 14 N/mm and 358 N/mm. Statistically significant differences between the tested screws were measured in terms of stiffness and elastic energy. One screw type failed insertion due to tip breakage. No significant differences occurred between screws in maximum pull-out force. The average pull-out values of SFFE were 14.1 N higher compared to human specimen. CONCLUSION: Orthodontic miniscrews provided rigid fixation when partially inserted in human temporal bone, as evidenced by pull-out forces and joint stiffness. Average values exceeded requirements despite variations between screws. Differences in stiffness and elastic energy indicate screw-specific interface mechanics. With proper insertion, orthodontic miniscrews appear suitable for microstereotactic frame anchoring during minimally invasive cochlear implant surgery. However, testing under more complex loading is needed to better predict clinical performance. For further pull-out tests, the most suitable substitute material is SFFE.


Assuntos
Parafusos Ósseos , Osso Temporal , Osso Temporal/cirurgia , Humanos , Animais , Suínos , Implante Coclear/métodos , Teste de Materiais , Cadáver , Bovinos , Procedimentos Cirúrgicos Minimamente Invasivos
15.
IEEE Trans Biomed Eng ; 70(1): 390-398, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35939462

RESUMO

OBJECTIVES: Drilling a minimally invasive access to the inner ear is a demanding task in which a computer-assisted surgical system can support the surgeon. Herein, we describe the design of a new micro-stereotactic targeting system dedicated to cochlear implant (CI) surgery and its experimental evaluation in an ex vivo study. METHODS: The proposed system consists of a reusable, bone-anchored reference frame, and a patient-specific drilling jig on top of it. Individualization of the jig is simplified to a single counterbored hole drilled out of a blank. For accurate counterboring, the setup includes a manufacturing device for individual positioning of the blank. The system was tested in a preclinical setting using twelve human cadaver donors. Cone beam computed tomograph (CBCT) scans were obtained and a drilling trajectory was planned pointing towards the basal part of the cochlea. The surgical drill was moved forward manually and slowly while the jig constrained the drill along the predetermined path. RESULTS: Drilling could be performed with preservation of facial nerve in all specimens. The mean error caused by the system at the target point in front of the cochlea was 0.30 mm ± 0.11 mm including an inaccuracy of 0.09 mm ± 0.03 mm for counterboring the guiding aperture into the jig. CONCLUSION: Feasibility of the proposed system to perform a minimally invasive posterior tympanotomy approach was shown successfully in all specimens. SIGNIFICANCE: First evaluation of the new system in a comprehensive ex vivo study demonstrating sufficient accuracy and the feasibility of the whole concept.


Assuntos
Implante Coclear , Implantes Cocleares , Cirurgia Assistida por Computador , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Cóclea/diagnóstico por imagem , Cóclea/cirurgia
16.
J Biomed Mater Res B Appl Biomater ; 110(11): 2494-2505, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35678249

RESUMO

For cochlear implants (CI) a final position of the electrode array (EA) along the inner wall of the spirally shaped cochlea is considered to be beneficial because it results in a closer proximity to the auditory nerve fibers. A shape memory effect (SME) could facilitate such shift of the EA toward the cochlear inner wall, but its implementation remains to be solved. The current study presents an EA prototype featuring the SME with minute adjustments of the material properties of Nitinol, a shape memory alloy, in combination with a suitable cooling strategy to prevent premature curling. Ten samples were successfully inserted by a CI surgeon into an artificial cochlear model submerged into a temperature-controllable water bath to simulate temporary hypothermia of the inner ear (31°C). Gentle insertions were possible, with an average insertion speed of 0.81 ± 0.14 mm/s. After recovery of body temperature, the desired position shift toward the modiolus was observed in all trials. Angular insertion depth increased by approximately 81.8° ± 23.4°. We demonstrate for the first time that using the body temperature responsive SME for perimodiolar EA positioning is feasible and does not impede a gentle surgical insertion.


Assuntos
Implante Coclear , Implantes Cocleares , Cóclea/cirurgia , Implante Coclear/métodos , Eletrodos Implantados , Ligas de Memória da Forma , Água
17.
J Med Imaging (Bellingham) ; 8(1): 015003, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33634206

RESUMO

Purpose: We explain our concept for customization of a guidance instrument, present a prototype, and describe a set of experiments to evaluate its positioning and drilling accuracy. Methods: Our concept is characterized by the use of bone cement, which enables fixation of a specific configuration for each individual surgical template. This well-established medical product was selected to ensure future intraoperative fabrication of the template under sterile conditions. For customization, a manually operated alignment device is proposed that temporary defines the planned trajectory until the bone cement is hardened. Experiments ( n = 10 ) with half-skull phantoms were performed. Analysis of accuracy comprises targeting validations and experiments including drilling in bone substitutes. Results: The resulting mean positioning error was found to be 0.41 ± 0.30 mm at the level of the target point whereas drilling was possible with a mean accuracy of 0.35 ± 0.30 mm . Conclusion: We proposed a cost-effective, easy-to-use approach for accurate instrument guidance that enables template fabrication under sterile conditions. The utilization of bone cement was proven to fulfill the demands of an easy, quick, and prospectively intraoperatively doable customization. We could demonstrate sufficient accuracy for many surgical applications, e.g., in neurosurgery. The system in this early development stage already outperforms conventional stereotactic frames and image-guided surgery systems in terms of targeting accuracy.

18.
Ear Hear ; 31(3): 413-9, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20440115

RESUMO

OBJECTIVES: Radiological evaluation of the position of cochlear implant (CI) devices is an upcoming method for quality control after CI surgery. First, results of imaging of the middle and inner ear with digital volume tomography (DVT) show considerable advantages such as exceptional image quality, thin slice thickness, and low radiation dose. The aim of this study was to evaluate whether DVT is an appropriate method for postoperative imaging of CI patients and to identify the exact position of the implant array within the cochlear by multiple measurements. DESIGN: Thirteen formalin-fixed temporal bone specimens were implanted with a CI array and scanned in DVT. To determine the exact electrode position, these specimens were ground and stained for microscopic measurements. The measurements on grindings acted as a referee and were compared with the measurements in DVT scans. The statistical analysis between the two measurement protocols was performed using the Bland-Altman method. RESULTS: Best achievable agreement between DVT scans and histological reference was shown. Mean differences between DVT and grindings from -1.55 to -65.40 microm were calculated. All means are within the region of accuracy. General positioning of the implant into the cochlea could be verified in all specimens. The exact position of the implanted array within the cochlear scalae could be recognized correctly in 11 of 13 cases in DVT. It was possible to identify shiftings between the tympanic and vestibular scalae in all cases. CONCLUSION: DVT seems to be a convenient technique for postoperative position control after cochlear implantation.


Assuntos
Cóclea/diagnóstico por imagem , Implantes Cocleares/efeitos adversos , Orelha Média/diagnóstico por imagem , Osso Temporal/diagnóstico por imagem , Microtomografia por Raio-X/métodos , Artefatos , Cadáver , Cóclea/lesões , Orelha Média/lesões , Eletrodos/efeitos adversos , Formaldeído , Humanos , Complicações Pós-Operatórias/diagnóstico por imagem , Controle de Qualidade , Reprodutibilidade dos Testes , Osso Temporal/lesões , Microtomografia por Raio-X/normas
19.
Cochlear Implants Int ; 21(2): 67-74, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31553273

RESUMO

Background: The aim of the study was to investigate the extent of MRI artefacts due to the magnet of selected auditory implants.Study design: Artefacts of the Synchrony cochlear implant at 1.5 T as well as at 3 T MRI devices were examined in cadavers and compared to the artefacts in MRI scans at 1.5 T of 17 patients implanted with CI (n = 12) and auditory brainstem implants (ABI) (n = 5).Results: None of the scanned implants showed any failure after MRI. After removal of the magnet, only a portion of the images in the direct neighbourhood of the implant, especially in the temporal and parietal lobe, contained artefacts. More anatomical substructures were visible without artefacts using the MedEl Synchrony device.Conclusion: Artefacts can be markedly reduced by rotating, self-aligning magnet. Removal of the magnet also results in reduction of artefacts.


Assuntos
Artefatos , Implantes Auditivos de Tronco Encefálico/efeitos adversos , Implantes Cocleares/efeitos adversos , Perda Auditiva Neurossensorial/diagnóstico por imagem , Imageamento por Ressonância Magnética , Tronco Encefálico/diagnóstico por imagem , Perda Auditiva Neurossensorial/cirurgia , Humanos , Imãs/efeitos adversos , Lobo Parietal/diagnóstico por imagem , Período Pós-Operatório , Estudos Retrospectivos , Lobo Temporal/diagnóstico por imagem
20.
Otol Neurotol ; 41(2): 178-185, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31789806

RESUMO

OBJECTIVE: The intracochlear position of an electrode array may influence the outcome after cochlear implantation. The design of the electrode array can increase the risk of trauma causing penetration of the basilar membrane or shift of the electrode array into the scala vestibuli. The aim of the present study was to identify a scalar shift after implantation of two different electrode arrays developed by one manufacturer. STUDY DESIGN: Retrospective analysis. SETTING: Tertiary referral center. PATIENTS AND INTERVENTION: Cochlear implant recipients implanted between 2010 and 2014 and receiving either a mid-scala (n = 30) or a perimodiolar (n = 30) electrode array. MAIN OUTCOME MEASURE: Occurrence of scalar shift in association with the electrode type. RESULTS: Scalar shift occurred in 26.7% (8 of 30) of the patients implanted with a perimodiolar electrode array and in 6.7% (2 of 30) of the patients implanted with the mid-scala electrode array. The mean insertion depth in the patients experiencing scalar shift after implantation of the mid-scala electrode was much deeper (21.59 ±â€Š0.34 mm) when compared with the mean insertion depth of the patients with scalar shift after implantation with a perimodiolar electrode array (17.85 ±â€Š2.19 mm). There tends to be a correlation between the cochlear length and the occurrence of a scalar shift. However, the number of patients with scalar shift in the mid-scala group is rather small. CONCLUSION: Based on the presented data, more patients implanted with a perimodiolar electrode array have a scalar shift when compared with the midscalar electrode array.


Assuntos
Implante Coclear , Implantes Cocleares , Cóclea/cirurgia , Eletrodos Implantados , Humanos , Estudos Retrospectivos , Rampa do Tímpano/cirurgia
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