Journal of Medical Devices-Transactions of the Asme最新文献

{"title":"Designing an Interchangeable Multi-Material Nozzle System for the Three-Dimensional Bioprinting Process","authors":"Cartwright Nelson, Slesha Tuladhar, MD Habib","doi":"10.1115/1.4055249","DOIUrl":"https://doi.org/10.1115/1.4055249","url":null,"abstract":"Abstract Three-dimensional bioprinting is a rapidly growing field attempting to recreate functional tissues for medical and pharmaceutical purposes. Development of functional tissue requires deposition of multiple biomaterials encapsulating multiple cell types, i.e., bio-ink necessitating switching ability between bio-inks. Existing systems use more than one print head to achieve this complex interchangeable deposition, decreasing efficiency, structural integrity, and accuracy. Therefore, the objective of this paper is to develop an alternative deposition system that will not require more than one print head for multimaterial bioprinting. To achieve that objective, we developed a nozzle system capable of switching between multiple bio-inks with continuous deposition, ensuring the minimum transition distance so that precise deposition transitioning can be achieved. This research progressed from a prototyping stage of nozzle system to the final selection of the system. Finally, the effect of rheological properties of different biomaterial compositions on the transition distance is investigated by fabricating the sample scaffolds.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136178984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and Testing of a Superelastic Nitinol Tissue Attachment Mechanism for Long-term Gastrointestinal Device Retention","authors":"M. M. Mau, Sunandita Sarker, Seth P Harris, Benjamin Terry","doi":"10.1115/1.4057058","DOIUrl":"https://doi.org/10.1115/1.4057058","url":null,"abstract":"\u0000 Ingestible devices have become a popular means for diagnosing and treating the gastrointestinal (GI) tract due to their noninvasive nature. However, their residency period in the GI tract is limited by the transit time through it. In previous work, we designed a tissue attachment mechanism (TAM) inspired by parasitic worms' attachment methods, which were tested for implanting biosensors or drug delivery payloads to the small intestine with a swallowable capsule robot. In that work, the attachment success rate was 91.7%, and the average attachment duration of the TAM was 32.2 hours after factorial optimization of major design factors. This work develops a novel nitinol TAM (NTAM) for improving the attachment duration using the shape-changing properties of nitinol. The attachment strength of the NTAM to the intestinal tissue was assessed ex vivo and in vivo. The attachment duration of the NTAMs in live porcine models was evaluated from radiographic images, and histological analysis of the attachment location of an NTAM was performed after euthanasia. The NTAM was 100% successful in an attachment strength study and achieved a maximum attachment duration of 13 days, while the average attachment duration was 85.63±77.83 hours. Histological analysis did not report any permanent damage to the tissue. This work shows a 2.7-fold improvement in attachment duration over the previous design. This work has demonstrated a method of prolonged attachment to the intestinal wall through a swallowable device, which can be used for long-term drug delivery or biosensing.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46122770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biologic: H-Bot Kinematics Based Multi-Micro-Extrusion Bioprinter","authors":"Levent Aydin, Ayfer Peker Karatoprak, Serdar Kucuk","doi":"10.1115/1.4056375","DOIUrl":"https://doi.org/10.1115/1.4056375","url":null,"abstract":"Abstract Three-dimensional bioprinting offers a novel strategy to create large-scale complex tissue models. Nowadays, layer by layer fabrication is used to create patient specific tissue substitutes. However, commercially available bioprinters cannot be widely used especially in small research facilities due to their high cost, and may not be suitable for bioprinting of complex tissue models. Besides, most of the systems are not capable of providing the required working conditions. The aim of this study is to design and assemble of a low-cost H-Bot based bioprinter that allows multimicro-extrusion to form complex tissue models in a closed cabin and sterile conditions. In this study, a micro-extrusion based bioprinter, Bio-Logic, with three different print heads, namely, Universal Micro-Extrusion Module (UMM), Multi-Micro-Extrusion Module (MMM), and Ergonomic Multi-Extrusion Module (EMM) were developed. The print heads were tested and scaffold models were bioprinted and analyzed. Bio-Logic was compared in price with the commercially available bioprinters. Scaffold fabrication was successfully performed with Bio-Logic. The average pore size of the scaffold was determined as 0.37±0.04 mm (n = 20). Total cost of Bio-Logic was considerably less than any other commercially available bioprinters. A new system is developed for bioprinting of complex tissue models. The cost of the system is appropriate for research and features of the device may be upgraded according to the needs. Bio-Logic is the first H-Bot kinematics based bioprinter and has ability to measure atmospheric conditions in a closed cabin.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136178986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of a Negative Pressure Containment Pod Within Ambulance-Workspace During Pandemic Response.","authors":"Mirle Pena, Dylan T Neu, H Amy Feng, Duane R Hammond, Kenneth R Mead, Rupak K Banerjee","doi":"10.1115/1.4056694","DOIUrl":"10.1115/1.4056694","url":null,"abstract":"<p><p>Emergency medical service (EMS) providers have a higher potential exposure to infectious agents than the general public (Nguyen et al., 2020, \"Risk of COVID-19 Among Frontline Healthcare Workers and the General Community: A Prospective Cohort Study,\" Lancet Pub. Health, <b>5</b>(9), pp. e475-e483; Brown et al., 2021, \"Risk for Acquiring Coronavirus Disease Illness Among Emergency Medical Service Personnel Exposed to Aerosol-Generating Procedures,\" Emer. Infect. Disease J., <b>27</b>(9), p. 2340). The use of protective equipment may reduce, but does not eliminate their risk of becoming infected as a result of these exposures. Prehospital environments have a high risk of disease transmission exposing EMS providers to bioaerosols and droplets from infectious patients. Field intubation procedures may be performed causing the generation of bioaerosols, thereby increasing the exposure of EMS workers to pathogens. Additionally, ambulances have a reduced volume compared to a hospital treatment space, often without an air filtration system, and no control mechanism to reduce exposure. This study evaluated a containment plus filtration intervention for reducing aerosol concentrations in the patient module of an ambulance. Aerosol concentration measurements were taken in an unoccupied research ambulance at National Institute for Occupational Safety and Health (NIOSH) Cincinnati using a tracer aerosol and optical particle counters (OPCs). The evaluated filtration intervention was a containment pod with a high efficiency particulate air (HEPA)-filtered extraction system that was developed and tested based on its ability to contain, capture, and remove aerosols during the intubation procedure. Three conditions were tested (1) baseline (without intervention), (2) containment pod with HEPA-1, and (3) containment pod with HEPA-2. The containment pod with HEPA-filtered extraction intervention provided containment of 95% of the total generated particle concentration during aerosol generation relative to the baseline condition, followed by rapid air cleaning within the containment pod. This intervention can help reduce aerosol concentrations within ambulance patient modules while performing aerosol-generating procedures.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9987460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9137240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Translatable System For Bi-directional Stimulation And Evoked Response Measurement To Enable Neuronal Network Exploration","authors":"Kristin N. Hageman, E. Peterson, P. Stypulkowski, Rob Corey, R. Jensen, T. Billstrom, T. Netoff, S. Stanslaski","doi":"10.1115/1.4056945","DOIUrl":"https://doi.org/10.1115/1.4056945","url":null,"abstract":"\u0000 Neural stimulation therapies and neural sensing continues to evolve as new technologies are introduced into clinical practice. A major confound in these types of neural recordings is the contamination of the signal of interest with electrical stimulus artifact, which can obscure short latency evoked activity and corrupt spectral analysis of longer duration signals. Approach. Here we describe the design and early pre-clinical evaluation of a neurostimulator with improved capabilities for both sensing and stimulation, with particular emphasis on managing stimulus artifact. The system was tested in three ovine deep brain stimulation (DBS) subjects, one with a DBS lead targeting the hippocampus, and two with DBS leads targeting the subthalamic nucleus (STN). All leads were externalized with percutaneous lead extensions. Results demonstrate that it was possible to record evoked potentials with a latency of 1–2 ms following stimulation in all subjects with the new system. Recordings from the hippocampal target showed clear short-latency responses exhibiting behavior consistent with evoked compound action potentials (ECAPs). In contrast, recordings from the STN target demonstrated highly resonant activity, dependent upon stimulus frequency, which could persist for 20–30 ms following individual stimuli. Both directional stimulation and directional recordings were evaluated to determine their influence on this evoked resonant neural activity (ERNA). The system was also characterized for sensing in one spinal cord stimulation (SCS) ovine subject and one sacral nerve modulation (SNM) ovine subject.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41919152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gravity Augmented Fused Filament Fabrication Additive Manufacturing","authors":"J. Huss, A. Erdman","doi":"10.1115/1.4056909","DOIUrl":"https://doi.org/10.1115/1.4056909","url":null,"abstract":"\u0000 This article introduces the design, methods, and use cases of a novel Gravity Augmented Additive Manufacturing (GAAM) approach to Fused Filament Fabrication (FFF) using a novel seven degree of freedom (DoF) delta robotic system. Capable of rotating parts and approaching the workpiece with the deposition head from user-specified or algorithm-determined angles, this system allows users the design freedom to create objects using less support material, while improving the performance of 3D printed components. Not only is time saved by reducing (or eliminating) support material, but components may be able to resist higher loading. Additionally, this system and the methods of operation described below allow users to create objects that are otherwise impossible or impractical to construct using traditional three axis FFF 3D printing, while maintaining compatibility with existing G-code preparation techniques. Finally, this more flexible 3D printing system has advanced applications in generating patient specific objects, which may benefit from more highly specialized toolpaths and design freedom afforded by this system.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43599761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal Design and Experiment of Cable-Driven Puncturing Surgery Robot for Soft Needle","authors":"Jihua Li, Qi Jiang","doi":"10.1115/1.4056865","DOIUrl":"https://doi.org/10.1115/1.4056865","url":null,"abstract":"\u0000 In this paper, a cable-driven puncturing surgery robot named CPSR is proposed for soft needle. The cable-driven mechanism has lower mass, smaller dimension and smooth transmission. The motor driving the rotational joints is separated using cable which strengthen the dynamic performance of the robot. A decoupling mechanism based on movable pulley is also proposed to reduce the transmission error. Transmission error of cable-driven mechanism are also analysed to improve the control accuracy. The simulation of transmission error is completed to optimize the design parameters of cable-driven mechanism. In puncturing experiments, the feasibility of the CPSR driving the soft needle using cable-based mechanism is validated. Also the insertion error less than 0.7 mm and repeatability less than 2.5 mm are achieved. Finally the reasons limiting the accuracy and corresponding solutions are discussed. In the future research, the shape sensor will be fabricated using optic fiber and mounted on the slim needle which is helpful to complete automated operations.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41596744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Novel Perturbation Platform System for Balance Response Testing and Rehabilitation Interventions","authors":"Corey Pew, Soroosh Sadeh, H. Hsiao, R. Neptune","doi":"10.1115/1.4056831","DOIUrl":"https://doi.org/10.1115/1.4056831","url":null,"abstract":"\u0000 Balance perturbations are often used to gain insight into reactive control strategies used to prevent falls. We developed a Perturbation Platform System (PPS) that can induce perturbations in both vertical and angled directions. The PPS was evaluated using human subject testing to verify its function and performance. The final system consisted of two box platforms that can individually perform vertical and angled surface perturbations. Following a perturbation, the system can automatically reset for the next iteration under the weight of the standing participant. The PPS achieves a peak downward acceleration of 4.4 m/s2 during drop events that simulate sudden surface changes. The experimental testing revealed that the perturbation induced a peak limb loading of 280 ± 38 % of body weight (BW) during vertical drops and that participants' center of mass displacements were consistent with previous balance studies evaluating vertical perturbations. The system can be used in a laboratory or clinical setting to better understand balance response and control mechanisms and assist in rehabilitation training to improve balance control and help mitigate the incidence of falls.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49331652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Bilayer Elasto-Hydrogel Adhesive Film for Facilitating Wet-Occlusive Therapy for Atopic Dermatitis","authors":"Joshua Pillai, Jonathan Pillai","doi":"10.1115/1.4056833","DOIUrl":"https://doi.org/10.1115/1.4056833","url":null,"abstract":"\u0000 Atopic dermatitis (AD) is a common chronic multifactorial skin disease that causes skin inflammation owing to defects in the skin barrier, immune dysregulation, or infectious agents. The most common treatment of AD utilizes wet-occlusion therapies to create a protective skin barrier by providing moisture to the epidermis. However, these treatments are suboptimal in managing disease symptoms owing to their limited ability to retain or restore skin hydration and inefficient drug delivery. Currently, there are no effective approaches for treating AD that are specifically designed to improve drug delivery efficacy and skin hydration. This study aims to introduce a new approach of localized drug delivery and facilitate more efficient dermal hydration using hydrogels and elastomers. Herein, we report a simple yet effective bilayer elasto-hydrogel adhesive film (BEHAF) dressing made from an interpenetrating alginate and polyacrylamide (alginate/AAm) hydrogel layer backed by a thin film of polydimethylsiloxane elastomer. In an in vitro hydration study, it was found that the BEHAF dressing enabled efficient retention and delivery of hydration to porcine skin and model epidermis for more than 48 h and showed potential for drug delivery of both hydrophobic and hydrophilic drugs. Furthermore, mechanical testing results indicate that the BEHAF mimics the elastic behavior of human skin and shows good adhesion sensitivity, thereby suggesting biomechanical compatibility and suitability for long-term usage. Overall, the BEHAF dressing may provide a viable vehicle for dermal hydration and drug delivery, thereby improving the efficacy of wet-occlusive therapy for treating AD.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43870432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Noninvasive Device to Predict Postoperative Ileus Using Acoustic Biomarkers","authors":"J. Hrabe, I. Gribovskaja-Rupp, K. Guyton, Muneera R. Kapadia, J. Cromwell","doi":"10.1115/1.4056832","DOIUrl":"https://doi.org/10.1115/1.4056832","url":null,"abstract":"\u0000 Purpose: For patients undergoing gastrointestinal surgery, postoperative ileus (POI) is difficult to predict and occurs at rates up to 30%. We hypothesized that discrete gastrointestinal acoustic biomarkers correlating to POI development may present in early postoperative hours. To test this hypothesis, we conducted a two-phase investigation to record and analyze intestinal sounds, then prospectively test the feasibility of predicting POI using a noninvasive device trained with an algorithm developed from Phase 1 results.\u0000 Methods: In Phase 1, a library of intestinal sounds from normal volunteer subjects and patients undergoing intestinal resection were recorded. An acoustic biomarker most correlated with POI was identified and used to develop a predictive algorithm. In Phase 2, an autonomous, wearable device possessing listening and signal processing capability was developed and prospectively tested for prediction of POI in patients undergoing bowel resection.\u0000 Results: In Phase 1, 30 patients undergoing resection were studied, 9 of whom developed POI, from which an acoustic biomarker was identified and analyzed. In Phase 2, prospective prediction of POI in 75 enrolled subjects undergoing bowel resection was assessed. POI was correctly predicted in 12 of 14 subjects who developed POI; prediction that POI would not occur was correct in 39 of 51 subjects. Sensitivity and specificity were 85.7% and 63.9%, respectively. Negative predictive value and accuracy were 95.1%, and 68%, respectively.\u0000 Conclusions: Our study demonstrates feasibility of POI prediction based on gastrointestinal sounds using a noninvasive device. This device may help risk stratify patients likely to develop POI.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47529162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}