RESUMO
Implant-associated infection (IAI) has become an intractable challenge in clinic. The healing of IAI is a complex physiological process involving a series of spatiotemporal connected events. However, existing titanium-based implants in clinic suffer from poor antibacterial effect and single function. Herein, a versatile surface platform based on the presentation of sequential function is developed. Fabrication of titania nanotubes and poly-γ-glutamic acid (γ-PGA) achieves the efficient incorporation of silver ions (Ag+) and the pH-sensitive release in response to acidic bone infection microenvironment. The optimized PGA/Ag platform exhibits satisfactory biocompatibility and converts macrophages from pro-inflammatory M1 to pro-healing M2 phenotype during the subsequent healing stage, which creates a beneficial osteoimmune microenvironment and promotes angio/osteogenesis. Furthermore, the PGA/Ag platform mediates osteoblast/osteoclast coupling through inhibiting CCL3/CCR1 signaling. These biological effects synergistically improve osseointegration under bacterial infection in vivo, matching the healing process of IAI. Overall, the novel integrated PGA/Ag surface platform proposed in this study fulfills function cascades under pathological state and shows great potential in IAI therapy.
Assuntos
Antibacterianos , Ácido Poliglutâmico , Prata , Titânio , Animais , Titânio/química , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Camundongos , Ácido Poliglutâmico/química , Ácido Poliglutâmico/análogos & derivados , Prata/química , Prata/farmacologia , Propriedades de Superfície , Nanotubos/química , Células RAW 264.7 , Infecções Relacionadas à Prótese/tratamento farmacológico , Osseointegração/efeitos dos fármacos , Osteogênese/efeitos dos fármacos , Osteoblastos/efeitos dos fármacos , Osteoblastos/citologia , Macrófagos/efeitos dos fármacos , Macrófagos/metabolismo , Masculino , Cicatrização/efeitos dos fármacos , Próteses e ImplantesRESUMO
Bioelectronic implants featuring soft mechanics, excellent biocompatibility, and outstanding electrical performance hold promising potential to revolutionize implantable technology. These biomedical implants can record electrophysiological signals and execute direct therapeutic interventions within internal organs, offering transformative potential in the diagnosis, monitoring, and treatment of various pathological conditions. However, challenges remain in improving excessive impedance at the bioelectronic-tissue interface and thus the efficacy of electrophysiological signaling and intervention. Here, we devise orbit symmetry breaking in MXene (a low-cost scalability, biocompatible, and conductive two dimensionally layered material, which we refer to as OBXene), which exhibits low bioelectronic-tissue impedance, originating from the out-of-plane charge transfer. Furthermore, the Schottky-induced piezoelectricity stemming from the asymmetric orbital configuration of OBXene facilitates interlayered charge transport in the device. We report an OBXene-based cardiac patch applied on the left ventricular epicardium of both rodent and porcine models to enable spatiotemporal epicardium mapping and pacing while coupling the wireless and battery-free operation for long-term real-time recording and closed-loop stimulation.
Assuntos
Próteses e Implantes , Animais , Suínos , Órbita/cirurgia , Impedância Elétrica , Materiais Biocompatíveis/químicaRESUMO
Somatosensory neuroprostheses restore, replace, or enhance tactile and proprioceptive feedback for people with sensory impairments due to neurological disorders or injury. Somatosensory neuroprostheses typically couple sensor inputs from a wearable device, prosthesis, robotic device, or virtual reality system with electrical stimulation applied to the somatosensory nervous system via noninvasive or implanted interfaces. While prior research has mainly focused on technology development and proof-of-concept studies, recent acceleration of clinical studies in this area demonstrates the translational potential of somatosensory neuroprosthetic systems. In this review, we provide an overview of neurostimulation approaches currently undergoing human testing and summarize recent clinical findings on the perceptual, functional, and psychological impact of somatosensory neuroprostheses. We also cover current work toward the development of advanced stimulation paradigms to produce more natural and informative sensory feedback. Finally, we provide our perspective on the remaining challenges that need to be addressed prior to translation of somatosensory neuroprostheses.
Assuntos
Córtex Somatossensorial , Humanos , Córtex Somatossensorial/fisiologia , Retroalimentação Sensorial/fisiologia , Pesquisa Translacional Biomédica/tendências , Pesquisa Translacional Biomédica/métodos , Próteses Neurais , Interfaces Cérebro-Computador/tendências , Estimulação Elétrica/métodos , Próteses e Implantes/tendênciasRESUMO
BACKGROUND: Bilateral malignant glaucoma induced by a capsular tension ring associated with ring-shaped cysts of the ciliary body post-cataract surgery is rare. Herein, we present a case to highlight the possibility of capsular tension ring-induced malignant glaucoma. CASE PRESENTATION: A 59-year-old woman underwent phacoemulsification combined with capsular tension ring implantation for cataracts and zonular fibre laxity in both eyes. Upon admission, annular ciliary masses were detected in both eyes using ultrasound biomicroscopy. Two months post-surgery, the patient experienced vision deterioration, high intraocular pressure, and an axial shallowing anterior chamber in the right eye, and responded poorly to traditional anti-glaucoma medication. Ten days later, similar symptoms appeared in the left eye. Ultrasound biomicroscopy detected contact between the ciliary body and the capsular tension ring. Subsequently, malignant glaucoma was diagnosed. Anterior and posterior capsulotomies performed peripheral to intraocular lens optics using neodymium: YAG laser restored communication and alleviated the symptoms. A one-year follow-up revealed stable intraocular pressure and anterior chamber in both eyes. CONCLUSIONS: This is the first case report of bilateral malignant glaucoma after cataract surgery induced by capsular tension ring, which is associated with bilateral ring-shaped cysts of the ciliary body. Blockage between the ciliary body and capsular tension ring was confirmed using ultrasound biomicroscopy.
Assuntos
Corpo Ciliar , Glaucoma , Pressão Intraocular , Facoemulsificação , Humanos , Feminino , Pessoa de Meia-Idade , Pressão Intraocular/fisiologia , Glaucoma/etiologia , Glaucoma/cirurgia , Facoemulsificação/efeitos adversos , Corpo Ciliar/diagnóstico por imagem , Microscopia Acústica , Complicações Pós-Operatórias , Implante de Lente Intraocular/efeitos adversos , Catarata/etiologia , Próteses e Implantes/efeitos adversos , Implantação de Prótese/efeitos adversosRESUMO
In this work, a novel tool for small-scale filament production is presented. Unlike traditional methods such as hot melt extrusion (HME), the device (i) allows filament manufacturing from small material amounts as low as three grams, (ii) ensures high diameter stability almost independent of the viscoelastic behavior of the polymer melt, and (iii) enables processing of materials with rheological profiles specifically tailored toward fused filament fabrication (FFF). Hence, novel materials, previously difficult to process due to HME limitations, become easily accessible for FFF for the first time. Here, we showcase the production of highly flexible drug-free, and drug-loaded filaments based on ethylene-vinyl acetate polymers with a vinyl acetate content of 28 w% (EVA28) and unprecedented high melt flow rates of up to 400 g/10 min. Owing to their low viscosity, FFF with low print nozzle sizes of 250 µm was achieved for the first time for EVA28. These small nozzle diameters facilitate 3D-printing of high-resolution structures in small-dimensional dosage forms such as subcutaneous implantable drug delivery systems, which can later be used for personalization. Consequently, the material portfolio for FFF is tremendously broadened, allowing material and formulation optimization toward FFF, independent of a preliminary extrusion process.
Assuntos
Polivinil , Impressão Tridimensional , Polivinil/química , Viscosidade , Sistemas de Liberação de Medicamentos , Reologia , Próteses e Implantes , Elasticidade , Medicina de Precisão , HumanosRESUMO
Cranioplasty is a reconstructive neurosurgical procedure that fixes the cranial bone defects after the craniotomy for brain surgeries like tumours, aneurysms, arterio-venous malformations, subdural empyemas and hematomas. Personalized 3D-printed implants offer various advantages, including anatomical accuracy, functional restoration, time-sparing surgery, excellent cosmetic outcomes through their impeccable adjustment to cranial vault defects, and better clinical outcomes. PEEK has a meritorious profile in terms of high success rate, low complication rate, fracture resistance and low toxicity profile, high strength, high toughness, and excellent biocompatibility in cranioplasty. On the other hand, the need for more cost-effective yet ideal biomaterials must be met for nations and patients with financial constraints. Nevertheless, this additively manufactured 3D-printed cranial implant marks the dawn of a new era in precision and personalized neurosurgery.
Assuntos
Benzofenonas , Procedimentos Neurocirúrgicos , Polímeros , Impressão Tridimensional , Próteses e Implantes , Crânio , Humanos , Crânio/cirurgia , Procedimentos Neurocirúrgicos/métodos , Cetonas , Procedimentos de Cirurgia Plástica/métodos , Medicina de Precisão/métodos , Materiais Biocompatíveis , Craniotomia/métodos , Polietilenoglicóis , NeurocirurgiaRESUMO
Bioelectronic bone implants are being widely recognized as a promising technology for highly personalized bone/implant interface sensing and biophysical therapeutic stimulation. Such bioelectronic devices are based on an innovative concept with the ability to be applied to a wide range of implants, including in fixation and prosthetic systems. Recently, biointerface sensing using capacitive patterns was proposed to overcome the limitations of standard imaging technologies and other non-imaging technologies; moreover, electric stimulation using capacitive patterns was proposed to overcome the limitations of non-instrumented implants. We here provide an innovative low-power miniaturized electronic system with ability to provide both therapeutic stimulation and bone/implant interface monitoring using network-architectured capacitive interdigitated patterns. It comprises five modules: sensing, electric stimulation, processing, communication and power management. This technology was validated using in vitro tests: concerning the sensing system, its ability to detect biointerface changes ranging from tiny to severe bone-implant interface changes in target regions was validated; concerning the stimulation system, its ability to significantly enhance bone cells' full differentiation, including matrix maturation and mineralization, was also confirmed. This work provides an impactful contribution and paves the way for the development of the new generation of orthopaedic biodevices.
Assuntos
Técnicas Biossensoriais , Técnicas Biossensoriais/instrumentação , Humanos , Estimulação Elétrica , Próteses e Implantes , Interface Osso-Implante/fisiologia , AnimaisRESUMO
Dynamic tracking of spinal instrumentation could facilitate real-time evaluation of hardware integrity and in so doing alert patients/clinicians of potential failure(s). Critically, no method yet exists to continually monitor the integrity of spinal hardware and by proxy the process of spinal arthrodesis; as such hardware failures are often not appreciated until clinical symptoms manifest. Accordingly, herein, we report on the development and engineering of a bio-adhesive metal detector array (BioMDA), a potential wearable solution for real-time, non-invasive positional analyses of osseous implants within the spine. The electromagnetic coupling mechanism and intimate interfacial adhesion enable the precise sensing of the metallic implants position without the use of radiation. The customized decoupling models developed facilitate the precise determination of the horizontal and vertical positions of the implants with incredible levels of accuracy (e.g., <0.5 mm). These data support the potential use of BioMDA in real-time/dynamic postoperative monitoring of spinal implants.
Assuntos
Metais , Próteses e Implantes , Coluna Vertebral , Dispositivos Eletrônicos Vestíveis , Humanos , Coluna Vertebral/cirurgia , Metais/química , Adesivos , Fusão Vertebral/instrumentação , Fusão Vertebral/métodosRESUMO
The current primary treatment approach for malignant pelvic tumors involves hemipelvic prosthesis reconstruction following tumor resection. In cases of Enneking type II + III pelvic tumors, the prosthesis necessitates fixation to the remaining iliac bone. Prevailing methods for prosthesis fixation include the saddle prosthesis, ice cream prosthesis, modular hemipelvic prosthesis, and personalized prosthetics using three-dimensional printing. To prevent failure of hemipelvic arthroplasty protheses, a novel fixation method was designed and finite element analysis was conducted. In clinical cases, the third and fourth sacral screws broke, a phenomenon also observed in the results of finite element analysis. Based on the original surgical model, designs were created for auxiliary dorsal iliac, auxiliary iliac bottom, auxiliary sacral screw, and auxiliary pubic ramus fixation. A nonlinear quasi-static finite element analysis was then performed under the maximum load of the gait cycle, and the results indicated that assisted sacral dorsal fixation significantly reduces stress on the sacral screws and relative micromotion exceeding 28 µm. The fixation of the pubic ramus further increased the initial stability of the prosthesis and its interface osseointegration ability. Therefore, for hemipelvic prostheses, incorporating pubic ramus support and iliac back fixation is advisable, as it provides new options for the application of hemipelvic tumor prostheses.
Assuntos
Análise de Elementos Finitos , Neoplasias Pélvicas , Humanos , Neoplasias Pélvicas/cirurgia , Ílio/cirurgia , Feminino , Parafusos Ósseos , Ossos Pélvicos/cirurgia , Masculino , Desenho de Prótese , Impressão Tridimensional , Próteses e Implantes , Sacro/cirurgiaRESUMO
PURPOSE: To assess the effectiveness of prophylactic capsular tension ring (CTR) implantation during cataract surgery in highly myopic eyes. SETTING: Eye and Ear, Nose, and Throat Hospital of Fudan University, Shanghai, China. DESIGN: Prospective cohort study. METHODS: Consecutive highly myopic patients treated with cataract surgery were recruited and randomized to undergo CTR implantation or not. The outcomes compared between the 2 groups included axial lens position (ALP), intraocular lens (IOL) decentration and tilt, area of anterior capsule opening, severity of anterior capsular opacification (ACO), and posterior capsular opacification (PCO) at 1 year postoperatively. RESULTS: A total of 55 highly myopic eyes with CTRs implanted and 55 without were included in the analysis. At 1 year postoperatively, no significant differences were detected between the CTR and non-CTR groups for the mean ALP, IOL decentration, or tilt (all P > .05). However, the CTR group had a significantly larger area of anterior capsule opening (23.62 ± 3.30 mm2 vs 21.85 ± 2.30 mm2, P = .003), and less severe ACO (P = .033) and PCO (PCO-3 mm: 0.06 ± 0.13 vs 0.13 ± 0.20, P = .038; PCO-C: 0.15 ± 0.18 vs 0.25 ± 0.26, P = .026) than the non-CTR group. The corrected distance visual acuity, prediction error, and higher-order aberrations did not differ between the 2 groups (all P > .05). CONCLUSIONS: In highly myopic eyes, although prophylactic CTR implantation can reduce the severity of capsular contraction and opacification, it does not significantly affect postoperative IOL stability or visual outcomes.
Assuntos
Implante de Lente Intraocular , Miopia Degenerativa , Facoemulsificação , Acuidade Visual , Humanos , Estudos Prospectivos , Miopia Degenerativa/complicações , Miopia Degenerativa/cirurgia , Miopia Degenerativa/fisiopatologia , Masculino , Feminino , Acuidade Visual/fisiologia , Pessoa de Meia-Idade , Idoso , Implantação de Prótese , Próteses e Implantes , Cápsula do Cristalino/cirurgia , Lentes Intraoculares , Opacificação da Cápsula/prevenção & controle , Opacificação da Cápsula/cirurgiaRESUMO
BACKGROUND: This study aims to accelerate revision surgery and treatment using X-ray imaging and deep learning to identify shoulder implant manufacturers in advance. METHODS: A feature engineering approach based on principal component analysis and a k-means algorithm was used to cluster shoulder implant data. In addition, a pre-trained DenseNet201 combined with a capsule network (DenseNet201-Caps) shoulder implant classification model was proposed. RESULTS: DenseNet201-Caps was the most effective classification model on the clustered dataset with an accuracy of 94.25% and an F1 score of 96.30%. Notably, clustering the dataset in advance improved the accuracy and the Caps implementations successfully enhanced the performance of all convolutional neural network models. The analysed results indicate that DenseNet201-Caps struggled to distinguish between the Cofield and Depuy manufacturers. Hence, a multistage classification approach was developed with an improved accuracy of 96.55% achieved. CONCLUSIONS: The DenseNet201-Caps method enables the accurate identification of shoulder implant manufacturers.
Assuntos
Algoritmos , Aprendizado Profundo , Redes Neurais de Computação , Humanos , Prótese de Ombro , Análise de Componente Principal , Ombro/cirurgia , Ombro/diagnóstico por imagem , Ombro/anatomia & histologia , Reoperação , Articulação do Ombro/cirurgia , Articulação do Ombro/diagnóstico por imagem , Próteses e ImplantesRESUMO
BACKGROUND AND OBJECTIVES: 3-Dimensional (3D) printing has become a common tool to aid implant molding for cranioplastic surgery of large skull defects. Until now, 3D printing of cranial implants itself has not been used, mainly because of medicolegal concerns. With a 3D printer developed for printing medical applications and with implant-grade polyetheretherketone (PEEK) filament available, we established a workflow (in compliance with medical device regulations) to 3D print cranial implants for cranioplastic surgery directly at the point of care (POC). Here, we describe the implementation of 3D printing these PEEK implants for cranioplastic surgery at our academic hospital. METHODS: A thorough design and 3D printing process, in accordance with local medical device regulations, was developed. Implants are digitally designed based upon pre- and post-craniectomy cranial computed tomography scans by trained 3D printing experts from the department of medical engineering at our institution. Implants are then produced on a medical 3D printer with implant-grade PEEK filament using the fused filament fabrication process. After postprocessing and steam sterilization, implantation for reconstruction of the skull can be performed. RESULTS: Cranioplastic surgery with a 3D-printed PEEK implant was performed at our institution in a patient with a large frontotemporoparietal skull defect after traumatic brain injury with consecutive decompressive craniectomy. No intra- or post-operative complications occurred. Postoperative cranial computed tomography scans showed perfect reconstruction of precraniectomy skull shape. The aesthetic result was promising and satisfactory to the patient. CONCLUSION: This novel 3D printing workflow enables the production of patient-specific cranial implants from PEEK, to reconstruct large skull defects directly at the POC in accordance with the European Medical Device Regulation. This marks an unprecedented technological and legal advancement, enabling the hospital infrastructure not only to deliver the cranioplastic surgery itself, but also additive manufacturing of the implant directly at the POC.
Assuntos
Benzofenonas , Cetonas , Sistemas Automatizados de Assistência Junto ao Leito , Polietilenoglicóis , Polímeros , Impressão Tridimensional , Crânio , Humanos , Crânio/cirurgia , Próteses e Implantes , Procedimentos de Cirurgia Plástica/métodos , Procedimentos de Cirurgia Plástica/instrumentação , Desenho de PróteseRESUMO
Achieving negative surgical margins, defined as no tumor found on the edges of the resected tissue, during lumpectomy for breast cancer is critical for mitigating the risk of local recurrence. To identify nonpalpable tumors that cannot be felt, pre-operative placements of wire and wire-free localization devices are typically employed. Wire-free localization approaches have significant practical advantages over wired techniques. In this study, we introduce an innovative localization system comprising a light-emitting diode (LED)-based implantable device and handheld system. The device, which is needle injectable and wire free, utilizes multiple wirelessly powered LEDs to provide direct visual guidance for lumpectomy. Two distinct colors, red and blue, provide a clear indication of tissue depth: blue light is absorbed strongly in tissue, visible within a close range of <1 cm, while red light remains visible through several centimeters of tissue. The LEDs, integrated with an impedance-matching circuit and receiver coil, are encapsulated in biocompatible epoxy for injection with a 12 G needle. Our findings demonstrate that the implant exhibits clearly perceivable depth-dependent color changes and remains visible through >2 cm of ex vivo chicken breast and bovine muscle tissue using less than 4 W of transmitted power from a handheld antenna. These miniaturized needle-injectable localization devices show promise for improving surgical guidance of nonpalpable breast tumors.
Assuntos
Neoplasias da Mama , Luz , Mastectomia Segmentar , Tecnologia sem Fio , Feminino , Mastectomia Segmentar/instrumentação , Animais , Neoplasias da Mama/cirurgia , Tecnologia sem Fio/instrumentação , Humanos , Próteses e Implantes , Bovinos , GalinhasRESUMO
BACKGROUND: Titanium has been the conventional implant material of choice for fixation in both primary and metastatic spine tumour surgeries (MSTS). However, these implants result in artefact generation during post-operative computed tomography (CT) or magnetic resonance imaging (MRI), resulting in poor planning of radiotherapy (RT) and suboptimal tumour surveillance. Carbon fibre-reinforced polyetheretherketone (CFR-PEEK) implants have gained momentum for instrumentation in MSTS due to their radiolucent properties. This in turn does not sacrifice the biomechanical strength of the implants. In this study, we compared the peri-operative outcomes, post operative imaging artefacts and dosimetricdata of CFR-PEEK implants to titanium implants to asses for potential benefits in post-operative RT planning in patients who underwent MSTS. METHODS: This is a retrospective study involving 42 patients operated for MSTS. Patient-related data including demographics, tumour pathology, intra-operative data, functional outcome, and RT-related data were collected for both groups. All patients were followed-up post-operatively for a minimum of 2 years or until demise, whichever was earlier. RESULTS: In our study, 20 (47.6%) patients had CFR-PEEK implants, while 22 (52.4%) of patients had titanium implants used for MSTS. Both groups of patients had similar clinical outcomes for pain and overall survival predictability pre-operatively (P>0.05). Mean number of levels instrumented by titanium screws were 6.8±2.93, while for the CFR-PEEK screws were 4.07±1.05. Mean volume of artefact generated during post operative CT was 75.1±43.4 mm3 in titanium group and 13.3±14.2 mm3 in CFR-PEEK group (P=0.005). The mean time taken to contour the artefacts was 17.3±5.84 minutes in the titanium group, while the CFR-PEEK group took 9.60±7.17 minutes (P=0.049). CONCLUSIONS: Our study suggests that carbon fibre reinforced PEEK screws significantly reduce artefact generation and the time taken to contour them during post-operative RT planning, while delivering equivalent clinical and functional outcomes as compared to standard titanium implants.
Assuntos
Benzofenonas , Fibra de Carbono , Cetonas , Polietilenoglicóis , Polímeros , Próteses e Implantes , Neoplasias da Coluna Vertebral , Humanos , Estudos Retrospectivos , Masculino , Feminino , Pessoa de Meia-Idade , Polietilenoglicóis/uso terapêutico , Neoplasias da Coluna Vertebral/cirurgia , Neoplasias da Coluna Vertebral/secundário , Adulto , Idoso , Metástase NeoplásicaRESUMO
Cardiovascular diseases (CVDs) are a predominant global health concern, accounting for over 17.9 million deaths in 2019, representing approximately 32% of all global fatalities. In North America and Europe, over a million adults undergo cardiac surgeries annually. Despite the benefits, such surgeries pose risks and require precise postsurgery monitoring. However, during the postdischarge period, where monitoring infrastructures are limited, continuous monitoring of vital signals is hindered. In this area, the introduction of implantable electronics is altering medical practices by enabling real-time and out-of-hospital monitoring of physiological signals and biological information postsurgery. The multimodal implantable bioelectronic platforms have the capability of continuous heart sensing and stimulation, in both postsurgery and out-of-hospital settings. Furthermore, with the emergence of machine learning algorithms into healthcare devices, next-generation implantables will benefit artificial intelligence (AI) and connectivity with skin-interfaced electronics to provide more precise and user-specific results. This Review outlines recent advancements in implantable bioelectronics and their utilization in cardiovascular health monitoring, highlighting their transformative deployment in sensing and stimulation to the heart toward reaching truly personalized healthcare platforms compatible with the Sustainable Development Goal 3.4 of the WHO 2030 observatory roadmap. This Review also discusses the challenges and future prospects of these devices.
Assuntos
Doenças Cardiovasculares , Humanos , Monitorização Fisiológica/instrumentação , Monitorização Fisiológica/métodos , Doenças Cardiovasculares/diagnóstico , Dispositivos Eletrônicos Vestíveis , Coração , Próteses e Implantes , Inteligência ArtificialRESUMO
Alloplastic materials are well suited for use in rhinoplasty in the right clinical scenarios, specifically in patients with platyrrhine noses and in challenging revision cases. The most commonly used materials today are silicone and high-density porous polyethylene. Both implant materials carry a unique set of properties and offer various advantages and disadvantages for use. Complications can be minimized with appropriate utilization of implants and using proper technique.
Assuntos
Próteses e Implantes , Rinoplastia , Silicones , Humanos , Rinoplastia/métodos , Rinoplastia/instrumentação , Desenho de Prótese , Materiais Biocompatíveis , Nariz/cirurgia , Nariz/anatomia & histologia , PolietilenoRESUMO
Background: Perspectives of patients, parents and professional experts on personalized regenerative implants for regenerative medicine purposes are largely unknown.Method: To better understand these perspectives, we conducted four focus groups with professional experts of mixed European nationality (n = 8), Dutch patients with regular implants (n = 8), Dutch and Belgian (n = 5) and Spanish (n = 8) parents of children with cleft palate.Results: Two overarching themes were identified: 'patient-centered research and care' and 'ambivalent attitudes toward personalized regenerative implants'.Discussion: The results reveal that stakeholders should adopt a participatory rather than an impairment discourse and address the ambivalence among professional experts, patients and parents.Conclusion: Considering stakeholder perspectives facilitates ethical and responsible development and use of personalized regenerative implants.
[Box: see text].
Assuntos
Grupos Focais , Pais , Medicina Regenerativa , Humanos , Medicina Regenerativa/métodos , Pais/psicologia , Masculino , Feminino , Próteses e Implantes , Pesquisa Qualitativa , Adulto , Medicina de Precisão/métodos , Pacientes/psicologiaAssuntos
Olho , Próteses e Implantes , Pesquisadores , Humanos , Traumatismos Oculares/cirurgia , Oftalmopatias/cirurgiaRESUMO
Mechanical testing machines are used to evaluate kinematics, kinetics, wear, and efficacy of spinal implants. The simulation of "physiological" spinal loading conditions necessitates the simultaneous use of multiple actuators. The challenge in achieving a desired loading profile lies in achieving close synchronization of these actuators. Errors in load application can be attributed to both the control system and the intrinsic sample response. Moreover, the presence of friction in the setup can have an impact on the measured outcome. The optimization of setup parameters can substantially improve the ability to simulate spinal loading conditions and obtain reliable data on implant performance. In this study, a reproducible kinematic test protocol was developed to evaluate the sensitivity of the kinetic response (i.e., measured loads, moments, and stiffnesses) of a cervical disc prosthesis to several testing parameters. In this context, five ceramic ball and socket sample implants were mounted in a 6 DOF material testing machine and tested with a constant axial compressive force of 100 N in two motion modes: 1) flexion-extension (±7.5°) and 2) lateral bending (±6°). Parameters including rotation rate, slider friction, friction between the samples' articulating surfaces, and moment arm were considered to determine their effects on measured kinetic parameters. The sensitivity analysis indicated that all setup parameters except friction between the samples' articulating surfaces had a substantial effect on the results. The findings were then compared to predictions from a free body diagram to determine the optimal setup parameters. Consequently, the setup with the lowest rotation rate and employing passive sliders yielded results that were consistent with the free body diagram. This study demonstrated the significance of a comprehensive setup evaluation for reliable and reproducible testing of spinal implants, also for comparison between labs.
Assuntos
Vértebras Cervicais , Teste de Materiais , Cinética , Vértebras Cervicais/cirurgia , Vértebras Cervicais/fisiologia , Próteses e Implantes , Disco Intervertebral/fisiologia , Disco Intervertebral/cirurgia , Fenômenos Biomecânicos , Fricção , Testes Mecânicos , Humanos , Suporte de CargaRESUMO
PURPOSE: To compare the postoperative outcomes following implantation of KERATACx ring segments (Imperial Medical Technologies Europe GmbH) in patients having eccentric keratoconus with three different topographic patterns. METHODS: This retrospective cohort study was conducted at Maadi Eye Subspeciality Center, Cairo, Egypt. The study included patients with keratoconus who had implantation of KERATACx ring segments. Three groups were segregated based on topographic keratoconus patterns using the Sirius CSO Topographer (CSO Italia): type I ectasia where the cone coincides with the corneal flat axis, type II ectasia in which the cone coincides with neither the steep nor the flat axis and lies between the two axes, and type II ectasia for cones coinciding with the corneal steep axis. The visual and topographic outcomes were compared preoperatively and postoperatively for the three enrolled groups. RESULTS: This study enrolled 92 eyes of 92 patients and had a mean ± standard deviation follow-up of 16.9 ± 9.2 months. The patients' medical records revealed that night vision complaints and halos around the light were experienced the most by the type III ectasia group (31.25%). For the type III ectasia group, four topographic indices and one visual parameter did not show statistically significant differences between the preoperative and postoperative data (inferior-superior difference at 2- and 4-mm diameter, coma aberration, higher order aberrations, and uncorrected distance visual acuity), contrary to the type I and II ectasia groups, which showed significant improvements in all evaluated parameters. CONCLUSIONS: The type III morphological pattern of ectasia is the least likely to benefit from KERATACx ring segments implantation. [J Refract Surg. 2024;40(9):e625-e634.].