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A 4 mo old male goldendoodle puppy was evaluated for chronic hematochezia with a history of recurrent rectal prolapse and tenesmus. A colo-colonic intussusception was diagnosed via abdominal imaging. Surgery was elected to reduce the intussusception, wherein a colonic mass was discovered. Colonic resection and anastomosis was performed, and the tissue were submitted for histopathological examination. The puppy was diagnosed with colonic hamartomatous ganglioneuromatosis based on the presence of markedly hyperplastic submucosal and myenteric plexi with infiltration and expansion of the mucosa and submucosa by Schwann cells and neuronal cell bodies. Ganglioneuromatosis is a rarely reported entity in the veterinary literature, and limited clinical follow up data is available for described cases. In humans, ganglioneuromatosis is associated with a PTEN genetic mutation, which confers increased susceptibility to the development of neoplasia of endocrine organs. Approximately 1 yr after the operation, this puppy appeared clinically normal with no abnormalities on repeated imaging. This case report describes the clinical presentation, surgical treatment, and histologic features of colonic hamartomatous ganglioneuromatosis with 1 yr postoperative clinical follow up data in a dog. Although uncommon, ganglioneuromatosis should be considered as a differential diagnosis list as a cause of gastrointestinal masses in puppies and young dogs.
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Doenças do Cão , Intussuscepção , Humanos , Cães , Animais , Masculino , Intussuscepção/veterinária , Doenças do Cão/diagnóstico , Doenças do Cão/cirurgia , Colo , Anastomose Cirúrgica/veterinária , Diagnóstico DiferencialRESUMO
This article describes the concept of Medical Device Interface Data Sheets (MDIDSs) to document and characterize medical device interface data requirements, the processes for creating MDIDSs, and its role in supporting patient safety and cybersecurity of current systems while enabling innovation in the area of next-generation medical Internet of Things (IoT) platforms for integrating sensors, actuators, and applications (apps).
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Segurança Computacional , Prestação Integrada de Cuidados de Saúde , Equipamentos e Provisões , Interoperabilidade da Informação em Saúde , Internet das Coisas , Telemedicina , Interface Usuário-Computador , Redes de Comunicação de Computadores , Desenho de Equipamento , Segurança de Equipamentos , Humanos , Segurança do Paciente , Design de Software , Integração de SistemasRESUMO
A technology-focused review of respiratory gas analysis, with an emphasis on carbon dioxide analysis, is presented. The measurement technologies deployed commercially are highlighted, and the basic principles and technical concerns of infrared spectroscopy and mainstream versus sidestream gas sampling are discussed. The specifications of particular interest to the clinician, accuracy and response time, and the related standard, with typical values for a capnometer, are presented. Representative time and volumetric capnograms are shown with the clinically relevant parameters described. Aspects of the terminology in present-day use and the need for clarity in defining what is a breath and an end-tidal value are reviewed. The applications of capnography of particular interest to the anesthesiologist are noted, and key references are provided. Ongoing developments with respect to respiratory gas analysis, and those that will impact it, are noted.
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Gasometria/métodos , Dióxido de Carbono/análise , Monitorização Intraoperatória/métodos , Mecânica Respiratória/fisiologia , Capnografia/métodos , HumanosRESUMO
OBJECTIVE: Laser tissue soldering using photothermal solders is a technology that facilitates rapid sealing using heat-induced changes in the tissue and the solder material. The solder material is made of gold nanorods embedded in a protein matrix patch that can be placed over the tissue rupture site and heated with a laser. Although laser tissue soldering is an attractive approach for surgical repair, potential photothermal damage can limit the success of this approach. Development of predictive mathematical models of photothermal effects including cell death, can lead to more efficient approaches in laser-based tissue repair. METHODS: We describe an experimental and modeling investigation into photothermal solder patches for sealing porcine and mouse cadaver intestine sections using near-infrared laser irradiation. Spatiotemporal changes in temperature were determined at the surface as well as various depths below the patch. A mathematical model, based on the finite element method, predicts the spatiotemporal temperature distribution in the patch and surrounding tissue, as well as concomitant cell death in the tissue is described. RESULTS: For both the porcine and mouse intestine systems, the model predicts temperatures that are quantitatively similar to the experimental measurements with the model predictions of temperature increase often being within a just a few degrees of experimental measurements. CONCLUSION: This mathematical model can be employed to identify optimal conditions for minimizing healthy cell death while still achieving a strong seal of the ruptured tissue using laser soldering. Lasers Surg. Med. 50:143-152, 2018. © 2017 Wiley Periodicals, Inc.
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Intestinos/efeitos da radiação , Intestinos/cirurgia , Fotocoagulação a Laser/métodos , Nanocompostos , Animais , Análise de Elementos Finitos , Técnicas In Vitro , Fotocoagulação a Laser/instrumentação , Lasers de Estado Sólido , Camundongos , Suínos , Temperatura , Fatores de TempoRESUMO
In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.
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Analgesia Controlada pelo Paciente/métodos , Analgésicos/administração & dosagem , Coleta de Dados/métodos , Medicina Baseada em Evidências/métodos , Segurança do Paciente , Avaliação da Tecnologia Biomédica/métodos , Analgesia Controlada pelo Paciente/efeitos adversos , Analgesia Controlada pelo Paciente/instrumentação , Analgésicos/efeitos adversos , Alarmes Clínicos , Comportamento Cooperativo , Documentação , Desenho de Equipamento , Falha de Equipamento , Humanos , Bombas de Infusão , Comunicação Interdisciplinar , Equipe de Assistência ao Paciente , Medição de Risco , Fatores de Risco , Fluxo de TrabalhoRESUMO
Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.
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Coleta de Dados/normas , Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Informática Médica/normas , Segurança do Paciente/normas , Integração de Sistemas , Avaliação da Tecnologia Biomédica/normas , Biomarcadores/sangue , Comportamento Cooperativo , Coleta de Dados/métodos , Eletrocardiografia , Registros Eletrônicos de Saúde , Desenho de Equipamento , Equipamentos e Provisões/efeitos adversos , Frequência Cardíaca , Humanos , Comunicação Interdisciplinar , Informática Médica/métodos , Registro Médico Coordenado , Oximetria/normas , Oxigênio/sangue , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Avaliação da Tecnologia Biomédica/métodosRESUMO
Quantitative features derived from the time-based and volumetric capnogram such as respiratory rate, end-tidal PCO2, dead space, carbon dioxide production, and qualitative features such as the shape of capnogram are clinical metrics recognized as important for assessing respiratory function. Researchers are increasingly exploring these and other known physiologically relevant quantitative features, as well as new features derived from the time and volumetric capnogram or transformations of these waveforms, for: (a) real-time waveform classification/anomaly detection, (b) classification of a candidate capnogram into one of several disease classes, (c) estimation of the value of an inaccessible or invasively determined physiologic parameter, (d) prediction of the presence or absence of disease condition, (e) guiding the administration of therapy, and (f) prediction of the likely future morbidity or mortality of a patient with a presenting condition. The work to date with respect to these applications will be reviewed, the underlying algorithms and performance highlighted, and opportunities for the future noted.
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Capnografia/métodos , Monitorização Fisiológica/métodos , Algoritmos , Dióxido de Carbono/química , Sistemas Computacionais , Registros Eletrônicos de Saúde , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa , Respiração Artificial , Taxa Respiratória , Processamento de Sinais Assistido por Computador , Software , Volume de Ventilação Pulmonar , Fatores de TempoRESUMO
The purpose of this retrospective study of 72 dogs was to compare a vessel sealing device with a surgical stapling device for performance of splenectomy. The results of this study demonstrate a statistically significant shorter surgical time for splenectomy, without an adverse effect on outcomes, performed in dogs with the vessel sealing device (mean time, 58.4 min ± 3.3 min; median time, 60 min; range, 22-131 min) compared with a traditional stapling device (mean time, 66.9 min ± 2.4 min; median time, 66 min; range, 40-100 min). No other significant differences were found between the two groups of patients.
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Doenças do Cão/cirurgia , Esplenectomia/veterinária , Esplenopatias/veterinária , Animais , Cães , Hemostasia Cirúrgica/instrumentação , Hemostasia Cirúrgica/veterinária , Estudos Retrospectivos , Esplenopatias/cirurgia , Fatores de TempoRESUMO
INTRODUCTION: The need for remote ventilator control has been highlighted by the COVID-19 Public Health Emergency. Remote ventilator control from outside a patient's room can improve response time to patient needs, protect health care workers, and reduce personal protective equipment (PPE) consumption. Extending remote control to distant locations can expand the capabilities of frontline health care workers by delivering specialized clinical expertise to the point of care, which is much needed in diverse health care settings, such as tele-critical care and military medicine. However, the safety and effectiveness of remote ventilator control can be affected by many risk factors, including communication failures and network disruptions. Consensus safety requirements and test methods are needed to assess the resilience and safety of remote ventilator control under communication failures and network disruptions. MATERIALS AND METHODS: We designed two test methods to assess the robustness, usability, and safety of a remote ventilator control prototype system jointly developed by Nihon Kohden OrangeMed, Inc. and DocBox, Inc. ("the NK-DocBox system") to control the operation of an NKV-550 critical care ventilator under communication failures and network disruptions. First, the robustness of the NKV-550 ventilator was tested using a remote-control application developed on OpenICE - an open-source medical device interoperability platform - to transmit customized high-frequency and erroneous remote-control commands that could be caused by communication failures in a real-world environment. The second method utilized a network emulator to create different types and severity of network quality of service (QoS) degradation, including bandwidth throttling, network delay and jitter, packet drop and reordering, and bit errors, in the NKV-DocBox system to quantitatively assess the impact on system usability and safety. RESULTS: The NKV-550 ventilator operated as expected when remote-control commands arrived as fast as once per second. It ignored erroneous commands attempting to adjust invalid ventilation parameters. When facing commands that set the ventilation mode and parameters to invalid values, it reset the ventilation mode or parameters to default values, the safety implication of which may merit further evaluation. When any network QoS attribute (except for packet reordering) started to degrade, the NK-DocBox System experienced interference to its remote-control function, such as delays in the transmission of ventilator data and remote-control commands within the system. When the network QoS was worse than 500 ms network delay, 100 ms network jitter, 1% data drop rate, 12 Mbps minimal bandwidth, or 1e-6 bit error rate, the system became unsafe to use. For example, ventilator waveforms visualized on the remote-control application demonstrated freezes, out-of-synchronization, and moving backwards; and the connection between the ventilator and the remote-control application became unstable. CONCLUSION: The presented test methods confirmed the robustness of the NKV-550 ventilator against high-frequency and erroneous remote control, quantified the impact of network disruptions on the usability, reliability, and safety of the NK-DocBox system and identified the minimum network QoS requirements for it to function safely. These generalizable test methods can be customized to evaluate other remote ventilator control technologies and remote control of other types of medical devices against communication failures and network disruptions.
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COVID-19 , SARS-CoV-2 , Ventiladores Mecânicos , Humanos , COVID-19/prevenção & controle , Ventiladores Mecânicos/normas , Reprodutibilidade dos Testes , Telemedicina/normas , Telemedicina/instrumentação , Cuidados Críticos/métodos , Cuidados Críticos/normas , ComunicaçãoRESUMO
OBJECTIVE: To compare laparoscopic gastropexy using 2 self-anchoring barbed sutures to gastropexy using laparoscopically tied intracorporeal knots. STUDY DESIGN: Prospective, randomized controlled, clinical trial. ANIMALS: Dogs (n = 30) weighing >16 kg. METHODS: Dogs were randomly assigned to 1 of 3 laparoscopic gastropexy groups: group 1 (controls), intracorporeal 2-0 polydioxanone sutures (PDSII, Ethicon); group 2, barbed suture (0 Quill™ PDO; Angiotech); and group 3, barbed suture (2-0 V-Loc™ 180; Covidien). Gastropexy suturing time (GST) and total surgery time (TST) were recorded for each dog. Complications were recorded. Each dog was examined by ultrasound (1, 3, and 6 months postoperatively) to ensure persistence of the gastropexy. One dog each in group 2 and group 3 had 2nd look laparoscopy to evaluate the gastropexy. RESULTS: All gastropexies were intact at 6 months. Mean GST was significantly longer for group 1 (36 minutes; range, 25-46 minutes) than for groups 2 (20 minutes; range, 16-37 minutes) and 3 (19 minutes; range, 15-30 minutes; P < .05), which were not significantly different from each other. Likewise TSTs for groups 2 and 3 were significantly shorter than for group 1 (P < .05). CONCLUSION: Barbed sutures (Quill™ and V-Loc™) allowed for effective intracorporeal laparoscopic suturing of an incisional gastropexy without tying intracorporeal knots.
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Doenças do Cão/cirurgia , Gastropexia/veterinária , Laparoscopia/veterinária , Volvo Gástrico/veterinária , Técnicas de Sutura/veterinária , Suturas/veterinária , Animais , Cães , Feminino , Gastropexia/instrumentação , Gastropexia/métodos , Laparoscopia/métodos , Masculino , Volvo Gástrico/cirurgiaRESUMO
Introduction: The objective of this study was to investigate the effect of a novel screw type on stiffness and failure characteristics of a tibial plateau leveling osteotomy (TPLO) construct under cyclic loading conditions. The authors hypothesized that bone-screw-fasteners (BSF) would result in superior biomechanical stability compared with locking buttress screws (LBS). Materials and Methods: Twelve pairs of canine cadaveric pelvic limbs were included in this ex vivo biomechanical study. A TPLO was performed using a 3.5mm locking TPLO plate and stabilized using either LBS or BSF. Cyclic loading was performed for 30,000 cycles at 4Hz with a peak-load of 1000N (50N valley). The cyclic test was then continued by stepwise incremental increase of peak-load at a rate of 75N per 500 cycles until failure. Results: Cycles to failure for LBS (44,260 ± 5,770) and BSF (41,540 ± 7,686) were not significantly different (p = 0.36). Maximum force for LBS (3,134 ± 797N) and BSF (2,940 ± 831N) was not significantly different either (p = 0.58). Dynamic stiffness for LBS (1,778 ± 932 N/mm) and BSF (1,574 ± 677 N/mm) was not significantly different (p = 0.58). Discussion: Stabilization of the TPLO with BSF provided similar biomechanical stability under cyclic axial loading conditions as the LBS. BSF may be an acceptable alternative to traditional locking screws for TPLO.
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Frontal plane slab fractures account for the majority of third carpal bone (C3) fractures in racing and performance horses. Recommended treatment is stabilization with a lagged AO cortical screw. Associated complications are fragment splitting, fragment spinning, and irritation of dorsal soft tissue structures. A novel, headless, cannulated screw with interlocking threads the Headless Compression Screw Fastener (HCSF) has been developed to resist multidirectional forces and bending moments; however, it has not been applied in the horse. Simulated C3 frontal plane slab fractures were created in nine paired carpi from equine cadaver limbs, fixed with either the HCSF or AO cortical bone screw, and loaded in shear to failure. The effect of screw type on stiffness, maximum load to failure, and yield load was assessed in separate linear mixed models. No significant (P< .05) difference between screw types was detected in terms of maximum load to failure (P= .084), stiffness (P= .26), or yield load (P= .088). Mode of failure was screw bending in all specimens. For some samples in both groups, failure was associated with the sagittal fracture at the screw-bone interface. The HCSF was successfully used to repair simulated third carpal bone fractures. The different head and thread pitches of the HCSF effectively compressed the fracture. The headless design eliminates the need for counter sinking. There was no significant difference in maximum load to failure, stiffness, nor yield load compared to the cortical screws. These results invite clinical application to be investigated.
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Ossos do Carpo , Fraturas Ósseas , Traumatismos da Mão , Doenças dos Cavalos , Traumatismos do Punho , Cavalos , Animais , Fixação Interna de Fraturas/métodos , Fixação Interna de Fraturas/veterinária , Fenômenos Biomecânicos , Parafusos Ósseos/veterinária , Fraturas Ósseas/cirurgia , Fraturas Ósseas/veterinária , Traumatismos do Punho/veterinária , Traumatismos da Mão/veterinária , Osso CorticalRESUMO
A series of bio-based hydrophobically modified isosorbide dimethacrylates, with para-, meta-, and ortho- benzoate aromatic spacers (ISBGBMA), are synthesized, characterized, and evaluated as potential dental restorative resins. The new monomers, isosorbide 2,5-bis(4-glyceryloxybenzoate) dimethacrylate (ISB4GBMA), isosorbide 2,5-bis(3-glyceryloxybenzoate) dimethacrylate (ISB3GBMA), and isosorbide 2,5-bis(2-glyceryloxybenzoate) dimethacrylate (ISB2GBMA), are mixed with triethylene glycol dimethacrylate (TEGDMA) and photopolymerized. The resulting polymers are evaluated for the degree of monomeric conversion, polymerization shrinkage, water sorption, glass transition temperature, and flexural strength. Isosorbide glycerolate dimethacrylate (ISDGMA) is synthesized, and Bisphenol A glycerolate dimethacrylate (BisGMA) is prepared, and both are evaluated as a reference. Poly(ISBGBMA/TEGDMA) series shows lower water sorption (39-44 µg/mm3) over Poly(ISDGMA/TEGDMA) (73 µg/mm3) but higher than Poly(BisGMA/TEGDMA) (26 µg/mm3). Flexural strength is higher for Poly(ISBGBMA/TEGDMA) series (37-45 MPa) over Poly(ISDGMA/TEGDMA) (10 MPa) and less than Poly(BisGMA/TEGDMA) (53 MPa) after immersion in phosphate-buffered saline (DPBS) for 24 h. Poly(ISB2GBMA/TEGDMA) has the highest glass transition temperature at 85 °C, and its monomeric mixture has the lowest viscosity at 0.62 Pa·s, among the (ISBGBMA/TEGDMA) polymers and monomer mixtures. Collectively, this data suggests that the ortho ISBGBMA monomer is a potential bio-based, BPA-free replacement for BisGMA, and could be the focus for future study.
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The ability to measure carbon dioxide (CO(2)) in the breath of a patient or capnometry, is one of the fundamental technological advances of modern medicine. I will chronicle the evolution and commercialization of mainstream capnometry based upon infrared measurement of CO(2) in the breath using information from the historical record and personal interviews with many of the developers.
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Anestesiologia/história , Anestesiologia/instrumentação , Testes Respiratórios/instrumentação , Capnografia/história , Capnografia/instrumentação , Dióxido de Carbono/análise , História do Século XX , Monitorização Fisiológica/instrumentação , Testes Respiratórios/métodos , Desenho de Equipamento , Humanos , Raios Infravermelhos , Intubação Intratraqueal/instrumentação , Intubação Intratraqueal/métodos , Monitorização Fisiológica/métodosRESUMO
The discovery of electric fields in biological tissues has led to efforts in developing technologies utilizing electrical stimulation for therapeutic applications. Native tissues, such as cartilage and bone, exhibit piezoelectric behavior, wherein electrical activity can be generated due to mechanical deformation. Yet, the use of piezoelectric materials have largely been unexplored as a potential strategy in tissue engineering, wherein a piezoelectric biomaterial acts as a scaffold to promote cell behavior and the formation of large tissues. Here we show, for the first time, that piezoelectric materials can be fabricated into flexible, three-dimensional fibrous scaffolds and can be used to stimulate human mesenchymal stem cell differentiation and corresponding extracellular matrix/tissue formation in physiological loading conditions. Piezoelectric scaffolds that exhibit low voltage output, or streaming potential, promoted chondrogenic differentiation and piezoelectric scaffolds with a high voltage output promoted osteogenic differentiation. Electromechanical stimulus promoted greater differentiation than mechanical loading alone. Results demonstrate the additive effect of electromechanical stimulus on stem cell differentiation, which is an important design consideration for tissue engineering scaffolds. Piezoelectric, smart materials are attractive as scaffolds for regenerative medicine strategies due to their inherent electrical properties without the need for external power sources for electrical stimulation.