An assessment of introducers used for airway management.

Different introducers are available to assist with tracheal intubation. Subtle differences in the design of introducers can have a marked effect on safety and performance. The Difficult Airway Society's Airway Device Evaluation Project Team proposal states that devices should only be purchased for which there is at least a case-control study on patients assessing airway devices. However, resources are not currently available to carry out a case-control study on all introducers available on the market. This study comprised a laboratory and manikin-based investigation to identify introducers that could be suitable for clinical investigation. We included six different introducers in laboratory-based assessments (design characteristics) and manikin-based assessments involving the participation of 30 anaesthetists. Each anaesthetist attempted placement in the manikin's trachea with each of the six introducers in a random order. Outcomes included first-time insertion success rate; insertion success rate; number of attempts; time to placement; and distance placed. Each anaesthetist also completed a questionnaire. First-time insertion success rate depended significantly on the introducer used (p = 0.0016) and varied from 47% (Armstrong and P3) to 77% (Intersurgical and Frova). Median time to placement (including oesophageal placement) varied from 10 s (Eschmann and Frova) to 20 s (P3) (p = 0.0025). Median time to successful placement in the trachea varied from 9 s (Frova) to 22 s (Armstrong) (p = 0.037). We found that the Armstrong and P3 devices were not as acceptable as other introducers and, without significant improvements to their design and characteristics, the use of these devices in studies on patients is questionable. The study protocol is suitable for differentiating between different introducers and could be used as a basis for assessing other types of devices.

Low cost exoskeleton manipulator using bidirectional triboelectric sensors enhanced multiple degree of freedom sensory system.

Rapid developments of robotics and virtual reality technology are raising the requirements of more advanced human-machine interfaces for achieving efficient parallel control. Exoskeleton as an assistive wearable device, usually requires a huge cost and complex data processing to track the multi-dimensional human motions. Alternatively, we propose a triboelectric bi-directional sensor as a universal and cost-effective solution to a customized exoskeleton for monitoring all of the movable joints of the human upper limbs with low power consumption. The corresponding movements, including two DOF rotations of the shoulder, twisting of the wrist, and the bending motions, are detected and utilized for controlling the virtual character and the robotic arm in real-time. Owing to the structural consistency between the exoskeleton and the human body, further kinetic analysis offers additional physical parameters without introducing other types of sensors. This exoskeleton sensory system shows a great potential of being an economic and advanced human-machine interface for supporting the manipulation in both real and virtual worlds, including robotic automation, healthcare, and training applications.

Facing COVID-19 pandemic: development of custom-made face mask with rapid prototyping system.

BACKGROUND: COVID-19 is a global pandemic. The virus spreads through respiratory droplets and close contact. Therefore, the availability of personal protective equipment (PPE) for healthcare professionals is essential. 3D printing technology could represent a valid option to ameliorate PPE shortages. METHODOLOGY: Custom-made face mask were designed on the basis of facial scan and then 3D-printed. The whole protocol is executed with freeware software and only required a 3D printer. Six healthcare workers wore the device weekly thus expressing a judgment regarding quality of work, respiratory and skin comfort. RESULTS: The estimated total cost of a single mask is approximately 5 USD. The virtual design of a complete mask lasted 68 minutes on average. Most healthcare workers rated comfort as very good. CONCLUSIONS: Based on the encouraging results obtained, we can confidently confirm that custom-made masks are novel and useful devices that may be used in the fight against COVID-19.

Computational fluid dynamics of the right atrium: Assessment of modelling criteria for the evaluation of dialysis catheters.

Central venous catheters are widely used in haemodialysis therapy, having to respect design requirements for appropriate performance. These are placed within the right atrium (RA); however, there is no prior computational study assessing different catheter designs while mimicking their native environment. Here, a computational fluid dynamics model of the RA, based on realistic geometry and transient physiological boundary conditions, was developed and validated. Symmetric, split and step catheter designs were virtually placed in the RA and their performance was evaluated by: assessing their interaction with the RA haemodynamic environment through prediction of flow vorticity and wall shear stress (WSS) magnitudes (1); and quantifying recirculation and tip shear stress (2). Haemodynamic predictions from our RA model showed good agreement with the literature. Catheter placement in the RA increased average vorticity, which could indicate alterations of normal blood flow, and altered WSS magnitudes and distribution, which could indicate changes in tissue mechanical properties. All designs had recirculation and elevated shear stress values, which can induce platelet activation and subsequently thrombosis. The symmetric design, however, had the lowest associated values (best performance), while step design catheters working in reverse mode were associated with worsened performance. Different tip placements also impacted on catheter performance. Our findings suggest that using a realistically anatomical RA model to study catheter performance and interaction with the haemodynamic environment is crucial, and that care needs to be given to correct tip placement within the RA for improved recirculation percentages and diminished shear stress values.

Integration of the M6 Cyberknife in the Moderato Monte Carlo platform and prediction of beam parameters using machine learning.

PURPOSE: This work describes the integration of the M6 Cyberknife in the Moderato Monte Carlo platform, and introduces a machine learning method to accelerate the modelling of a linac. METHODS: The MLC-equipped M6 Cyberknife was modelled and integrated in Moderato, our in-house platform offering independent verification of radiotherapy dose distributions. The model was validated by comparing TPS dose distributions with Moderato and by film measurements. Using this model, a machine learning algorithm was trained to find electron beam parameters for other M6 devices, by simulating dose curves with varying spot size and energy. The algorithm was optimized using cross-validation and tested with measurements from other institutions equipped with a M6 Cyberknife. RESULTS: Optimal agreement in the Monte Carlo model was reached for a monoenergetic electron beam of 6.75 MeV with Gaussian spatial distribution of 2.4 mm FWHM. Clinical plan dose distributions from Moderato agreed within 2% with the TPS, and film measurements confirmed the accuracy of the model. Cross-validation of the prediction algorithm produced mean absolute errors of 0.1 MeV and 0.3 mm for beam energy and spot size respectively. Prediction-based simulated dose curves for other centres agreed within 3% with measurements, except for one device where differences up to 6% were detected. CONCLUSIONS: The M6 Cyberknife was integrated in Moderato and validated through dose re-calculations and film measurements. The prediction algorithm was successfully applied to obtain electron beam parameters for other M6 devices. This method would prove useful to speed up modelling of new machines in Monte Carlo systems.

Low-cost synthetic tourniquet training model. / Modelo sintético de baixo custo para treinamento do uso de torniquete.

OBJECTIVE: to present a low-cost model for bleeding control training with the use of a tourniquet and the results of the training evaluation. METHOD: low-cost and easy-to-purchase materials, such as upholstery foam, ethylene-vinyl acetate (EVA) sheet, plastic propulsion pump, saline container, water, school paint, serum equipment, rubber tubing for tourniquet, and a leg and an arm of a ghost mannequin, were used. In the model assembly, we created an active bleeding simulation system, which could only be controlled with the correct application of the tourniquet. The model was submitted to professional and academic evaluation. RESULTS: the model was similar to human anatomy, proved to be practical in the bleeding control training with the use of a tourniquet, and had low cost. CONCLUSION: the model for bleeding control training had excellent acceptability, was considered viable for educational purposes of tourniquet use, and had low cost.

OBJETIVO: apresentar um modelo de baixo custo para treinamento de controle de sangramento com o uso de torniquete e os resultados da avaliação do treinamento. MÉTODO: foram utilizados materiais de fácil aquisição e de baixo custo, como espuma de estofado, placa de etileno-acetato de vinila (EVA), bomba plástica de propulsão, recipiente de soro fisiológico, água, tinta escolar, equipos de soro, tubo de látex para garrote e manequins comerciais de perna e de braço. Na montagem, foi criado um sistema de simulação de sangramento ativo que só podia ser controlado com aplicação correta do torniquete. O modelo foi submetido à avaliação de profissionais e acadêmicos. RESULTADOS: o modelo teve semelhança com a anatomia humana, mostrou-se prático no treinamento da contenção de sangramento com uso de torniquete e teve baixo custo financeiro. CONCLUSÃO: o modelo para treinamento de controle de sangramento teve excelente aceitabilidade, foi considerado viável para fins educacionais do uso de torniquete e teve baixo custo.

Assessment of miniaturized ultrasound-powered implants: an in vivo study.

OBJECTIVE: Therapeutic applications of implantable active medical devices have improved the quality of patient life. Numerous on-going research in the field of neuromodulation and bioelectronic medicine are exploring the use of these implants for treating diseases and conditions. Miniaturized implantable medical devices that are wirelessly powered by ultrasound (US) can be placed close to the target sites deep inside the body for effective therapy with less invasiveness. In this study, we assessed the long-term in vivo performance of miniaturized US powered implants (UPI) using a rodent model. APPROACH: Prototype UPI devices were implanted in rodents and powered wirelessly using an unfocused US transmitter over 12 weeks, and the corresponding device output was recorded. Structural integrity of UPI before and after implantation was studied using scanning electron microscopy (SEM). We also conducted qualitative histological assessment of skin and muscle surrounding the UPI and compared it to naïve control and US exposed tissues. MAIN RESULTS: We found that it is feasible to power UPI devices wirelessly with US over long-term. The encapsulation of UPIs did not degrade over time and the tissues surrounding the UPI were comparable to both naïve control and US exposed tissues. SIGNIFICANCE: This study is the first to assess the long-term performance of miniaturized UPI devices using a rodent model over 12-weeks. The set of tests used in this study can be extended to assess other US-powered miniaturized implants.

In-vitro pliability assessment of embolization coils for intracranial aneurysm treatment.

BACKGROUND: Embolization coils have routinely been used to treat intracranial aneurysms via an endovascular approach. Soft coils are typically viewed as the best design for filling and finishing the aneurysms to achieve a higher packing density and are hypothesized to exert a lower force against the aneurysm wall during deployment. We report here an in vitro pliability test method to assess clinically relevant coil softness and compare these metrics for two commercially available framing and finishing coil products. METHODS: A force measurement sensor was affixed onto a side-wall synthetic aneurysm model to continuously measure forces on the aneurysm wall during coil deployment at a fixed delivery rate. A quantitative overall energy metric (average work number or AWN) was calculated from the force-displacement graph representing coil delivery into the aneurysm. Two groups of coils were evaluated: (a) finish coil group (N = 20 ea.): Axium™ Prime Extra Soft coil (ES) and Target™ 360 Nano coil (Nano), and (b) frame coil group (N = 20 ea.): Axium™ Prime FC coil (FC) and Target™ 360 Standard coil (Standard). RESULTS: (a) In the finish coil group, AWN was measured as: ES (0.53 ±â€¯0.09 gf-cm) and Nano (0.99 ±â€¯0.21 gf-cm). (b) In the frame coil group, AWN was measured as FC (2.54 ±â€¯0.53 gf-cm) and Standard (4.48 ±â€¯0.52 gf-cm). In both groups, Axium Prime coils had statistically lower measures of AWN and therefore higher pliability compared to Target coils (p < .001). CONCLUSIONS: The in-vitro pliability test method offers quantitative metrics to assess coil softness during deployment in a clinically relevant aneurysm model.

Chest tube simulator: development of low-cost model for training of physicians and medical students. / Simulador de dreno de tórax: desenvolvimento de modelo de baixo custo para capacitação de médicos e estudantes de medicina.

OBJECTIVE: by using a 3D printer, to create a low-cost human chest cavity simulator that allows the reproduction of the closed chest drainage technique (CCD), comparing its effectiveness with that of the animal model. METHODS: it was made a 3D printing of the bony framework of a human thorax from a chest computerized tomography scan. After printing the ribs, we performed tests with several materials that contributed to form the simulation of the thoracic cavity and pleura. An experimental, randomized, and controlled study, comparing the efficacy of the simulator to the efficacy of the animal model, was then carried out in the teaching of CCD technique for medical students, who were divided into two groups: animal model group and simulator model group, that trained CCD technique in animals and in the simulator model, respectively. RESULTS: the chest reconstruction required anatomical knowledge for tomography analysis and for faithful 3D surface editing. There was no significant difference in the safety of performing the procedure in both groups (7.61 vs. 7.73; p=0.398). A higher score was observed in the simulator model group for "use as didactic material" and "learning of the chest drainage technique", when compared to the animal model group (p<0.05). CONCLUSION: the final cost for producing the model was lower than that of a commercial simulator, what demonstrates the feasibility of using 3D printing for this purpose. In addition, the developed simulator was shown to be equivalent to the animal model in relation to the simulation of the drainage technique for practical learning, and there was preference for the simulator model as didactic material.

OBJETIVO: criar, em impressora 3D, um simulador de baixo custo de caixa torácica humana que permita a reprodução da técnica de drenagem fechada de tórax (DFT) comparando sua eficácia com a do modelo animal. MÉTODOS: foi realizada impressão 3D do arcabouço ósseo de um tórax humano a partir de uma tomografia de tórax. Após a impressão das costelas, foram realizados testes com diversos materiais que contribuíram para formar a simulação da caixa torácica e da pleura. Foi, então, realizado um estudo experimental, randomizado e controlado comparando sua eficácia ao modelo animal no ensino da DFT para estudantes de medicina, que foram divididos em dois grupos: Grupo Modelo Animal e Grupo Modelo Simulador, que treinaram DFT em animais e no modelo simulador, respectivamente. RESULTADOS: a reconstrução do tórax exigiu o conhecimento anatômico para análise da tomografia e para edição fiel da superfície 3D. Não houve diferença significativa quanto à segurança de realizar o procedimento entre os grupos (7,61 vs. 7,73; p=0,398). Foi observada maior pontuação no grupo modelo simulador para uso como material didático e aprendizado da técnica de drenagem torácica quando comparado ao grupo modelo animal (p<0,05). CONCLUSÃO: o custo final para a confecção do modelo foi inferior ao de um simulador comercial, o que demonstra a viabilidade do uso da impressão 3D para esse fim. Além disso, o simulador desenvolvido se mostrou equivalente ao modelo animal quanto à simulação da técnica de drenagem para aprendizado prático e houve preferência pelo modelo simulador como material didático.

A Low-Cost Indoor Activity Monitoring System for Detecting Frailty in Older Adults.

Indoor localization systems have already wide applications mainly for providing localized information and directions. The majority of them focus on commercial applications providing information such us advertisements, guidance and asset tracking. Medical oriented localization systems are uncommon. Given the fact that an individual's indoor movements can be indicative of his/her clinical status, in this paper we present a low-cost indoor localization system with room-level accuracy used to assess the frailty of older people. We focused on designing a system with easy installation and low cost to be used by non technical staff. The system was installed in older people houses in order to collect data about their indoor localization habits. The collected data were examined in combination with their frailty status, showing a correlation between them. The indoor localization system is based on the processing of Received Signal Strength Indicator (RSSI) measurements by a tracking device, from Bluetooth Beacons, using a fingerprint-based procedure. The system has been tested in realistic settings achieving accuracy above 93% in room estimation. The proposed system was used in 271 houses collecting data for 1⁻7-day sessions. The evaluation of the collected data using ten-fold cross-validation showed an accuracy of 83% in the classification of a monitored person regarding his/her frailty status (Frail, Pre-frail, Non-frail).

Simulador de dreno de tórax: desenvolvimento de modelo de baixo custo para capacitação de médicos e estudantes de medicina / Chest tube simulator: development of low-cost model for training of physicians and medical students

RESUMO Objetivo: criar, em impressora 3D, um simulador de baixo custo de caixa torácica humana que permita a reprodução da técnica de drenagem fechada de tórax (DFT) comparando sua eficácia com a do modelo animal. Métodos: foi realizada impressão 3D do arcabouço ósseo de um tórax humano a partir de uma tomografia de tórax. Após a impressão das costelas, foram realizados testes com diversos materiais que contribuíram para formar a simulação da caixa torácica e da pleura. Foi, então, realizado um estudo experimental, randomizado e controlado comparando sua eficácia ao modelo animal no ensino da DFT para estudantes de medicina, que foram divididos em dois grupos: Grupo Modelo Animal e Grupo Modelo Simulador, que treinaram DFT em animais e no modelo simulador, respectivamente. Resultados: a reconstrução do tórax exigiu o conhecimento anatômico para análise da tomografia e para edição fiel da superfície 3D. Não houve diferença significativa quanto à segurança de realizar o procedimento entre os grupos (7,61 vs. 7,73; p=0,398). Foi observada maior pontuação no grupo modelo simulador para uso como material didático e aprendizado da técnica de drenagem torácica quando comparado ao grupo modelo animal (p<0,05). Conclusão: o custo final para a confecção do modelo foi inferior ao de um simulador comercial, o que demonstra a viabilidade do uso da impressão 3D para esse fim. Além disso, o simulador desenvolvido se mostrou equivalente ao modelo animal quanto à simulação da técnica de drenagem para aprendizado prático e houve preferência pelo modelo simulador como material didático.

ABSTRACT Objective: by using a 3D printer, to create a low-cost human chest cavity simulator that allows the reproduction of the closed chest drainage technique (CCD), comparing its effectiveness with that of the animal model. Methods: it was made a 3D printing of the bony framework of a human thorax from a chest computerized tomography scan. After printing the ribs, we performed tests with several materials that contributed to form the simulation of the thoracic cavity and pleura. An experimental, randomized, and controlled study, comparing the efficacy of the simulator to the efficacy of the animal model, was then carried out in the teaching of CCD technique for medical students, who were divided into two groups: animal model group and simulator model group, that trained CCD technique in animals and in the simulator model, respectively. Results: the chest reconstruction required anatomical knowledge for tomography analysis and for faithful 3D surface editing. There was no significant difference in the safety of performing the procedure in both groups (7.61 vs. 7.73; p=0.398). A higher score was observed in the simulator model group for "use as didactic material" and "learning of the chest drainage technique", when compared to the animal model group (p<0.05). Conclusion: the final cost for producing the model was lower than that of a commercial simulator, what demonstrates the feasibility of using 3D printing for this purpose. In addition, the developed simulator was shown to be equivalent to the animal model in relation to the simulation of the drainage technique for practical learning, and there was preference for the simulator model as didactic material.

Modelo sintético de baixo custo para treinamento do uso de torniquete / Low-cost synthetic tourniquet training model

RESUMO Objetivo: apresentar um modelo de baixo custo para treinamento de controle de sangramento com o uso de torniquete e os resultados da avaliação do treinamento. Método: foram utilizados materiais de fácil aquisição e de baixo custo, como espuma de estofado, placa de etileno-acetato de vinila (EVA), bomba plástica de propulsão, recipiente de soro fisiológico, água, tinta escolar, equipos de soro, tubo de látex para garrote e manequins comerciais de perna e de braço. Na montagem, foi criado um sistema de simulação de sangramento ativo que só podia ser controlado com aplicação correta do torniquete. O modelo foi submetido à avaliação de profissionais e acadêmicos. Resultados: o modelo teve semelhança com a anatomia humana, mostrou-se prático no treinamento da contenção de sangramento com uso de torniquete e teve baixo custo financeiro. Conclusão: o modelo para treinamento de controle de sangramento teve excelente aceitabilidade, foi considerado viável para fins educacionais do uso de torniquete e teve baixo custo.

ABSTRACT Objective: to present a low-cost model for bleeding control training with the use of a tourniquet and the results of the training evaluation. Method: low-cost and easy-to-purchase materials, such as upholstery foam, ethylene-vinyl acetate (EVA) sheet, plastic propulsion pump, saline container, water, school paint, serum equipment, rubber tubing for tourniquet, and a leg and an arm of a ghost mannequin, were used. In the model assembly, we created an active bleeding simulation system, which could only be controlled with the correct application of the tourniquet. The model was submitted to professional and academic evaluation. Results: the model was similar to human anatomy, proved to be practical in the bleeding control training with the use of a tourniquet, and had low cost. Conclusion: the model for bleeding control training had excellent acceptability, was considered viable for educational purposes of tourniquet use, and had low cost.

A Low-Cost Stove Use Monitor to Enable Conditional Cash Transfers.

Conditional cash transfers (CCTs)-cash payments provided to households or specific household members who meet defined conditions or fulfill certain behaviors-have been extensively used in India to encourage antenatal care, institutional delivery, and vaccination. This paper describes the social design and technical development of a low-cost, meal-counting stove use monitor (the Pink Key) that enables a CCT based on liquefied petroleum gas (LPG) usage and presents pilot data from its testing and the initial deployment. The system consists of a sensing harness attached to a two-burner LPG stove and an easily removable datalogger. For each cooking event with LPG, households receive 2 rupees-less than the cost of fuel, but enough to partially defray LPG refill costs. The system could enable innovative "self-monitoring" at a large scale-participants initiate the CCT by bringing their Pink Key to antenatal clinic visits, where care providers download data and initiate payments, and participants return the sensor to their stove at home. The system aligns with existing Indian programs to improve health among poor, pregnant women, and contributes a new method to encourage the use of clean cooking technologies.

High-Speed Microscopy of Diffusion in Pore-Spanning Lipid Membranes.

Pore-spanning membranes (PSMs) provide a highly attractive model system for investigating fundamental processes in lipid bilayers. We measure and compare lipid diffusion in the supported and suspended regions of PSMs prepared on a microfabricated porous substrate. Although some properties of the suspended regions in PSMs have been characterized using fluorescence studies, it has not been possible to examine the mobility of membrane components on the supported membrane parts. Here, we resolve this issue by employing interferometric scattering microscopy (iSCAT). We study the location-dependent diffusion of DOPE 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine) lipids (DOPE) labeled with gold nanoparticles in (1,2-dioleoyl-sn-glycero-3-phosphocholine) (DOPC) bilayers prepared on holey silicon nitride substrates that were either (i) oxygen-plasma-treated or (ii) functionalized with gold and 6-mercapto-1-hexanol. For both substrate treatments, diffusion in regions suspended on pores with diameters of 5 µm is found to be free. In the case of functionalization with gold and 6-mercapto-1-hexanol, similar diffusion coefficients are obtained for both the suspended and the supported regions, whereas for oxygen-plasma-treated surfaces, diffusion is almost 4 times slower in the supported parts of the membranes. We attribute this reduced diffusion on the supported parts in the case of oxygen-plasma-treated surfaces to larger membrane-substrate interactions, which lead to a higher membrane tension in the freestanding membrane parts. Furthermore, we find clear indications for a decrease of the diffusion constant in the freestanding regions away from the pore center. We provide a detailed characterization of the diffusion behavior in these membrane systems and discuss future directions.

Syringe Port: A Convenient, Safe, and Cost-Effective Tubular Retractor for Transportal Removal of Deep-Seated Lesions of the Brain.

OBJECTIVE: Minimally invasive transportal resection of deep intracranial lesions has become a widely accepted surgical technique. Many disposable, mountable port systems are available in the market for this purpose, like the ViewSite Brain Access System. The objective of this study was to find a cost-effective substitute for these systems. METHODS: Deep-seated brain lesions were treated with a port system made from disposable syringes. The syringe port could be inserted through minicraniotomies placed and planned with navigation. All deep-seated lesions like ventricular tumours, colloid cysts, deep-seated gliomas, and basal ganglia hemorrhages were treated with this syringe port system and evaluated for safety, operative site hematomas, and blood loss. RESULTS: 62 patients were operated on during the study period from January 2015 to July 2017, using this innovative syringe port system for deep-seated lesions of the brain. No operative site hematoma or contusions were seen along the port entry site and tract. CONCLUSIONS: Syringe port is a cost-effective and safe alternative to the costly disposable brain port systems, especially for neurosurgical setups in developing countries for minimally invasive transportal resection of deep brain lesions.

Simple, low-cost fabrication of semi-circular channel using the surface tension of solder paste and its application to microfluidic valves.

This work presents a simple, low-cost method to fabricate semi-circular channels using solder paste, which can amalgamate the cooper surface to form a half-cylinder mold using the surface tension of Sn-Pd alloy (the main component in solder paste). This technique enables semi-circular channels to be manufactured with different dimensions. These semi-circular channels will then be integrated with a polymethylmethacrylate frame and machine screws to create miniaturized, portable microfluidic valves for sequential liquid delivery and particle synthesis. This approach avoids complicated fabrication processes and expensive facilities and thus has the potential to be a useful tool for lab-on-a-chip applications.

A New Device for Securing Sternal Wires After Median Sternotomy: Biomechanical Study and Retrospective Clinical Assessment.

OBJECTIVE: Morbidity due to sternotomy continues to be a significant clinical problem. Poor approximation of the sternum may lead to complications such as sternal dehiscence, infection, and pain. A device to assist in tensioning and twisting standard steel wires during sternal closure has been developed (TORQ sternal closure device). Manually tightened interrupted wire closures were compared with those tightened and secured with the aid of the device. Performance of the device was assessed clinically. METHODS: Four cardiovascular surgeons performed manual and device-assisted closures on a biofidelic model. Closure force was measured to determine the residual force and its intraoperator variation. A retrospective review of patients treated before and after the introduction of the device was conducted. Predicted and actual outcomes were compared for the two groups (manual closure and device-assisted closure). RESULTS: Biomechanical testing measured a 75% increase in residual closure force (P < 0.001) and a significant reduction in the variability of the closure force (P = 0.045) for device-assisted closures compared with manual closures. In the retrospective study, 3 of 173 manually closed patients had sterile sternal dehiscence and 1 of 173 had a deep sternal wound infection. In the device closure group, 2 of 127 had a sterile sternal dehiscence and no deep sternal wound infections were reported. No other device-related serious adverse events were reported. CONCLUSIONS: Biomechanical data showed stronger, more consistent closure forces with the device. The retrospective data attest to the performance of the device.

Assessment of tobacco heating product THP1.0. Part 2: Product design, operation and thermophysical characterisation.

A novel tobacco heating product, THP1.0, that heats tobacco below 245 °C is described. It was designed to eliminate tobacco combustion, while heating tobacco to release nicotine, tobacco volatiles and glycerol to form its aerosol. The stewardship assessment approach behind the THP 1.0 design was based on established toxicological principles. Thermophysical studies were conducted to examine the extent of tobacco thermal conversion during operation. Thermogravimetric analysis of the tobacco material revealed the major thermal behaviour in air and nitrogen up to 900 °C. This, combined with the heating temperature profiling of the heater and tobacco rod, verified that the tobacco was not subject to combustion. The levels of tobacco combustion markers (CO, CO2, NO and NOx) in the aerosol of THP1.0 were significantly lower than the levels if there were any significant pyrolysis or combustion. Quantification of other tobacco thermal decomposition and evaporative transfer markers showed that these levels were, on average, reduced by more than 90% in THP1.0 aerosol as compared with cigarette smoke. The physical integrity of the tobacco consumable rod showed no ashing. Taken together, these data establish that the aerosol generated by THP1.0 is produced mainly by evaporation and distillation, and not by combustion or pyrolysis.