Brianna L. Slatnick, Lumeng J. Yu, Alexander Yang, Kyle C Wu, Robert Crum, P. Betit, Mark Brown, Chad Pires, J. Priest, S. Staffa, Christopher Weldon, S. Fishman, Heung Bae Kim, Farokh R. Demehri
The COVID-19 pandemic created an unprecedented shortage of personal protective equipment (PPE) for healthcare workers - especially respirators. In response to a lack of commercial respirator equipment, a multidisciplinary prototyping hackathon was held and the key components required to develop an inexpensive, scalable "COVID-19 Reusable Elastomeric Respirator" (RER-19) were identified. Available hospital supplies were assessed based on their published technical specifications to meet each of the key component requirements. The fully assembled prototype was then validated through user testing, and volunteers underwent standard fit testing with cardiopulmonary monitoring while wearing the RER-19 in a small pilot study. Multiple social media platforms were then used to disseminate educational information on respirator assembly, use, and maintenance. Here we present our institution's initial experience with prototyping to meet a specific healthcare challenge, in combination with prompt dissemination of information to educate and empower healthcare workers in the face of a critical PPE shortage during an unprecedented and evolving pandemic.
{"title":"Early Experiences Designing a Scalable COVID-19 Reusable Elastomeric Respirator","authors":"Brianna L. Slatnick, Lumeng J. Yu, Alexander Yang, Kyle C Wu, Robert Crum, P. Betit, Mark Brown, Chad Pires, J. Priest, S. Staffa, Christopher Weldon, S. Fishman, Heung Bae Kim, Farokh R. Demehri","doi":"10.1115/1.4054055","DOIUrl":"https://doi.org/10.1115/1.4054055","url":null,"abstract":"\u0000 The COVID-19 pandemic created an unprecedented shortage of personal protective equipment (PPE) for healthcare workers - especially respirators. In response to a lack of commercial respirator equipment, a multidisciplinary prototyping hackathon was held and the key components required to develop an inexpensive, scalable \"COVID-19 Reusable Elastomeric Respirator\" (RER-19) were identified. Available hospital supplies were assessed based on their published technical specifications to meet each of the key component requirements. The fully assembled prototype was then validated through user testing, and volunteers underwent standard fit testing with cardiopulmonary monitoring while wearing the RER-19 in a small pilot study. Multiple social media platforms were then used to disseminate educational information on respirator assembly, use, and maintenance. Here we present our institution's initial experience with prototyping to meet a specific healthcare challenge, in combination with prompt dissemination of information to educate and empower healthcare workers in the face of a critical PPE shortage during an unprecedented and evolving pandemic.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49183327","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}
E. Malaekah, Khaled Al Awam, Husham Farouk, Elamir Abuabid, V. Mukhanov, A. Alahmari, Hasan Alshagag
Mechanical ventilators are advanced life-supporting machines in the present century. The ventilator needs to be safe, flexible, and easy for competent clinicians to use. Since ventilators supply the patient with gas, they need pneumatic components to be present. First technology ventilators were typically powered by pneumatic energy. Gas pressure is used to power ventilators as well as ventilate patients. Nowadays, ventilators are operated electronically with the useful microprocessor tool. This proposal aims to design a simple portable mechanical ventilator that includes measuring some important physiological variables such as respiratory rate, heart rate, and O2 saturation, which can be utilized in hospital and at home. The proposed system includes Arduino, Rasspary pi4, touch screen and graphical user interface. This study showed a significant individual performance for measuring some important parameters such as flow rate, tidal volume, and minute ventilation. The accuracy of measuring the flow rate was 72%. The Cohen's Kappa (CK) was estimated to be 0.61. The accuracy of calculated the tidal volume was estimated at 83% with 0.80 CK. The accuracy of measuring the O2 saturation was estimated at 99% with 0.99 CK. The advantages of the proposed design are cost-effective, safe, flexible, and easy to use. Also, this system is smart and can control its transactions, so it can be used at home without the need for professional help. The operating parameters can also be set by the user with a simple user interface.
{"title":"Designing Hybrid Mechanical Ventilator System Based On Arduino and Raspberry Pi 4","authors":"E. Malaekah, Khaled Al Awam, Husham Farouk, Elamir Abuabid, V. Mukhanov, A. Alahmari, Hasan Alshagag","doi":"10.1115/1.4054036","DOIUrl":"https://doi.org/10.1115/1.4054036","url":null,"abstract":"\u0000 Mechanical ventilators are advanced life-supporting machines in the present century. The ventilator needs to be safe, flexible, and easy for competent clinicians to use. Since ventilators supply the patient with gas, they need pneumatic components to be present. First technology ventilators were typically powered by pneumatic energy. Gas pressure is used to power ventilators as well as ventilate patients. Nowadays, ventilators are operated electronically with the useful microprocessor tool. This proposal aims to design a simple portable mechanical ventilator that includes measuring some important physiological variables such as respiratory rate, heart rate, and O2 saturation, which can be utilized in hospital and at home. The proposed system includes Arduino, Rasspary pi4, touch screen and graphical user interface. This study showed a significant individual performance for measuring some important parameters such as flow rate, tidal volume, and minute ventilation. The accuracy of measuring the flow rate was 72%. The Cohen's Kappa (CK) was estimated to be 0.61. The accuracy of calculated the tidal volume was estimated at 83% with 0.80 CK. The accuracy of measuring the O2 saturation was estimated at 99% with 0.99 CK. The advantages of the proposed design are cost-effective, safe, flexible, and easy to use. Also, this system is smart and can control its transactions, so it can be used at home without the need for professional help. The operating parameters can also be set by the user with a simple user interface.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48847589","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}
Connie Lee, A. Crouch, A. Jha, A. Adapa, Jose Diaz, A. Pandey, J. Greve, K. Pipe
Thermal therapies have strong potential for improving outcomes for patients suffering from cardiac arrest, neonatal hypoxic-ischemic encephalopathy, or medically refractory intracranial hypertension. We propose a novel tool to manipulate blood temperature through extravascular thermoelectric heat exchange of blood vessel walls and flowing blood. This tool is a concentrated cooling probe with several thermoelectric units combined to focus cooling at the application site. Using this tool, we aim to achieve desired levels of temperature control and potentially reduce complications associated with traditional intravascular or systemic thermal therapies. Leveraging the feedback control, speed, and reversible operation of thermoelectric cooling modules, the device can adapt to cool or heat as desired. Pre-clinical testing on rodent models confirmed rapid, significant reduction of intravenous jugular blood temperature when a prototype device was brought in contact with the left carotid artery (change in blood temperature of -4.74 ± 2.9 °C/hr and -4.29 ± 1.64 °C/hr for 0 °C and -5 °C cooling trials respectively). Declines in rectal temperature were also noted, but at lesser magnitudes than for jugular blood (0 °C: -3.09 ± 1.29 °C/hr; -5 °C: -2.04 ± 1.08), indicating proof-of-concept of thermoelectric extravascular blood cooling within a relatively localized region of the body. With further improvements in the technique, there is potential for selective organ cooling via reduction in flowing blood temperature.
{"title":"Extravascular Cooling of Blood Using a Concentrated Thermoelectric Cooling Probe","authors":"Connie Lee, A. Crouch, A. Jha, A. Adapa, Jose Diaz, A. Pandey, J. Greve, K. Pipe","doi":"10.1115/1.4054003","DOIUrl":"https://doi.org/10.1115/1.4054003","url":null,"abstract":"\u0000 Thermal therapies have strong potential for improving outcomes for patients suffering from cardiac arrest, neonatal hypoxic-ischemic encephalopathy, or medically refractory intracranial hypertension. We propose a novel tool to manipulate blood temperature through extravascular thermoelectric heat exchange of blood vessel walls and flowing blood. This tool is a concentrated cooling probe with several thermoelectric units combined to focus cooling at the application site. Using this tool, we aim to achieve desired levels of temperature control and potentially reduce complications associated with traditional intravascular or systemic thermal therapies. Leveraging the feedback control, speed, and reversible operation of thermoelectric cooling modules, the device can adapt to cool or heat as desired. Pre-clinical testing on rodent models confirmed rapid, significant reduction of intravenous jugular blood temperature when a prototype device was brought in contact with the left carotid artery (change in blood temperature of -4.74 ± 2.9 °C/hr and -4.29 ± 1.64 °C/hr for 0 °C and -5 °C cooling trials respectively). Declines in rectal temperature were also noted, but at lesser magnitudes than for jugular blood (0 °C: -3.09 ± 1.29 °C/hr; -5 °C: -2.04 ± 1.08), indicating proof-of-concept of thermoelectric extravascular blood cooling within a relatively localized region of the body. With further improvements in the technique, there is potential for selective organ cooling via reduction in flowing blood temperature.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48458673","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}
B. Butters, Á. Fernández-Galiana, D. Wollin, G. Traverso, A. Slocum, J. Petrozza
The fixation and manipulation of fibroids during laparoscopic myomectomy is a persistent issue for gynecologic surgeons. In this paper, we present a laparoscopic grasper that, through a sheath-based deployment mechanism, opens into a larger multi-toothed grasper within the patient and collapses back for removal. Due to the increased number of contact points with the tumor, the expanded grasper allows for reliable fixation, aiding in manipulation during excision. We describe the nature-inspired design of the grasper from a physical foundation, establish the design theory and practical issues, and present manufacturing and testing of a full-scale 5 mm grasper. The unit was tested on synthetic fibroid models and was able to sustain a 50% higher load before tearing than a common single-tooth tenaculum. This development not only promises to improve fibroid fixation in myomectomy, but its design could be adapted to aid in the fixation of other difficult tissues in laparoscopic surgery.
{"title":"A Retractable Six-Prong Laparoscopic Grasper for Laparoscopic Myomectomy","authors":"B. Butters, Á. Fernández-Galiana, D. Wollin, G. Traverso, A. Slocum, J. Petrozza","doi":"10.1115/1.4054013","DOIUrl":"https://doi.org/10.1115/1.4054013","url":null,"abstract":"\u0000 The fixation and manipulation of fibroids during laparoscopic myomectomy is a persistent issue for gynecologic surgeons. In this paper, we present a laparoscopic grasper that, through a sheath-based deployment mechanism, opens into a larger multi-toothed grasper within the patient and collapses back for removal. Due to the increased number of contact points with the tumor, the expanded grasper allows for reliable fixation, aiding in manipulation during excision. We describe the nature-inspired design of the grasper from a physical foundation, establish the design theory and practical issues, and present manufacturing and testing of a full-scale 5 mm grasper. The unit was tested on synthetic fibroid models and was able to sustain a 50% higher load before tearing than a common single-tooth tenaculum. This development not only promises to improve fibroid fixation in myomectomy, but its design could be adapted to aid in the fixation of other difficult tissues in laparoscopic surgery.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42236276","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}
N. Onwudiwe, R. Charter, B. Gingles, P. Abrishami, Henry Alder, Ameet Bahkai, Diane Civic, M. Kosaner Kließ, C. Lessard, Carla Zema
Background: Health Technology Assessment methods have become an important health policy tool. Yet recommendations for what constitutes appropriate and reliable evidence for assessment of medical devices are still debated because methods to evaluate pharmaceuticals are often, and incorrectly, the starting point for assessments. Objectives: The study aims to: (i) propose recommendations on appropriate methodologies to assess the evidence on medical devices (ii) identify assessment methods that can be used to measure device value and (iii) suggest key areas for future work Methods: ISPOR's Medical Devices and Diagnostics Special Interest Group conducted a comprehensive search of databases and gray literature on evidence development and value assessment on medical devices. The literature search was supplemented with hand searching from high impact journals in the related field. The 10-person expert working group obtained written comments through multiple rounds of review from internal and external stakeholders. Recommendations were made to guide future research. Results: Multi-criteria decision analysis was identified as a useful approach to assess the value of treatment. Consideration should be given to resource use measures; valid and reliable functional status questionnaires; and general and disease-specific, health-related, quality-of-life measures in economic evaluations of device use. For future work, best practices for value framework design. Conclusions: Integration of value-based evidence in an evidence-generation and -synthesis process is needed to support market access and adoption. Methodological recommendations for measuring value can be challenging when the selection of domains and assessment of value are not device-specific.
{"title":"Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An Ispor Medical Devices and Diagnostics Special Interest Group Report","authors":"N. Onwudiwe, R. Charter, B. Gingles, P. Abrishami, Henry Alder, Ameet Bahkai, Diane Civic, M. Kosaner Kließ, C. Lessard, Carla Zema","doi":"10.1115/1.4053928","DOIUrl":"https://doi.org/10.1115/1.4053928","url":null,"abstract":"\u0000 Background: Health Technology Assessment methods have become an important health policy tool. Yet recommendations for what constitutes appropriate and reliable evidence for assessment of medical devices are still debated because methods to evaluate pharmaceuticals are often, and incorrectly, the starting point for assessments.\u0000 Objectives:\u0000 The study aims to: (i) propose recommendations on appropriate methodologies to assess the evidence on medical devices (ii) identify assessment methods that can be used to measure device value and (iii) suggest key areas for future work\u0000 Methods:\u0000 ISPOR's Medical Devices and Diagnostics Special Interest Group conducted a comprehensive search of databases and gray literature on evidence development and value assessment on medical devices. The literature search was supplemented with hand searching from high impact journals in the related field. The 10-person expert working group obtained written comments through multiple rounds of review from internal and external stakeholders. Recommendations were made to guide future research.\u0000 Results:\u0000 Multi-criteria decision analysis was identified as a useful approach to assess the value of treatment. Consideration should be given to resource use measures; valid and reliable functional status questionnaires; and general and disease-specific, health-related, quality-of-life measures in economic evaluations of device use. For future work, best practices for value framework design.\u0000 Conclusions:\u0000 Integration of value-based evidence in an evidence-generation and -synthesis process is needed to support market access and adoption. Methodological recommendations for measuring value can be challenging when the selection of domains and assessment of value are not device-specific.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45177337","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}
Paul L. Briant, J. Bischoff, M. Dharia, Franck Le Navéaux, Xuemei Li, Sanjeev M. Kulkarni, Danny Levine, David Ramos, Payman Afshari
Evaluating the credibility of computational models used in medical device development is increasingly important as medical devices become more complex and modeling takes on a more critical role in the device development process. While bench-testing based comparisons are common for assessing model credibility and have many advantages, such as control over test specimens and the ability to quantify outputs, the credibility assessments performed with bench tests often do not evaluate the clinical relevance of key aspects of model form (such as boundary conditions, constitutive models/properties, and geometries) selected when simulating in vivo conditions. Real-world data (outcomes data generated through clinical use of a device) offer an opportunity to assess the applicability and clinical relevance of a computational model. Although real-world data are frequently less controlled and more qualitative than benchtop data, real-world data are often a direct assessment of a particular clinical complication and therefore of high clinical relevance. Further, real-world data have the potential to reveal failure modes not previously identified in pre-clinical failure modes analysis, thereby motivating testing advancements. To review the use of clinical data in medical device modeling, this paper presents a series of examples related to tibial tray fracture that incorporate varying levels of benchtop data and real world data when evaluating model credibility. The merits and drawbacks of the credibility assessment for each example are discussed in order to provide practical and actionable guidance on the use of real world data for establishing and demonstrating model credibility.
{"title":"Use of Real-World Data for Enhancing Model Credibility: Applications to Medical Device Development","authors":"Paul L. Briant, J. Bischoff, M. Dharia, Franck Le Navéaux, Xuemei Li, Sanjeev M. Kulkarni, Danny Levine, David Ramos, Payman Afshari","doi":"10.1115/1.4053888","DOIUrl":"https://doi.org/10.1115/1.4053888","url":null,"abstract":"\u0000 Evaluating the credibility of computational models used in medical device development is increasingly important as medical devices become more complex and modeling takes on a more critical role in the device development process. While bench-testing based comparisons are common for assessing model credibility and have many advantages, such as control over test specimens and the ability to quantify outputs, the credibility assessments performed with bench tests often do not evaluate the clinical relevance of key aspects of model form (such as boundary conditions, constitutive models/properties, and geometries) selected when simulating in vivo conditions.\u0000 Real-world data (outcomes data generated through clinical use of a device) offer an opportunity to assess the applicability and clinical relevance of a computational model. Although real-world data are frequently less controlled and more qualitative than benchtop data, real-world data are often a direct assessment of a particular clinical complication and therefore of high clinical relevance. Further, real-world data have the potential to reveal failure modes not previously identified in pre-clinical failure modes analysis, thereby motivating testing advancements. To review the use of clinical data in medical device modeling, this paper presents a series of examples related to tibial tray fracture that incorporate varying levels of benchtop data and real world data when evaluating model credibility. The merits and drawbacks of the credibility assessment for each example are discussed in order to provide practical and actionable guidance on the use of real world data for establishing and demonstrating model credibility.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48066375","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}
David S. Kirn, William F. Whitman, Richard D. Hisel, J. Price
Background: Tube patency is essential for patients who receive enteral nutrition via a small bore naso-enteral feeding tube. Formation of a clog within these tubes interrupts and delays delivery of nutrition. Unfortunately, current tubes are prone to clogging. A small-bore naso-enteral feeding tube that gradually increases in diameter over its length could mitigate the risk of clog formation. Methods: Small-bore feeding tubes that increase in diameter over their length, were evaluated relative to current (constant diameter) tubes to determine if a tapered tube design could reduce the pressure required to clear an established clog in benchtop testing at pressures representative of those achieved safely in the clinical environment. Results: Incorporating a tapered design into an 8F nasal feeding tube significantly reduced the pressure to expel an established clog by 62% (p < 0.05; 258.6 kPa vs. 710.8 kPa, respectively). Conclusion: When compared to constant diameter tubes with the same proximal outside diameter, a tapered tube design permits clearance of an established clog at lower pressure.
{"title":"Analysis of a Novel Nasoenteral Tube Design","authors":"David S. Kirn, William F. Whitman, Richard D. Hisel, J. Price","doi":"10.1115/1.4053876","DOIUrl":"https://doi.org/10.1115/1.4053876","url":null,"abstract":"\u0000 Background: Tube patency is essential for patients who receive enteral nutrition via a small bore naso-enteral feeding tube. Formation of a clog within these tubes interrupts and delays delivery of nutrition. Unfortunately, current tubes are prone to clogging. A small-bore naso-enteral feeding tube that gradually increases in diameter over its length could mitigate the risk of clog formation.\u0000 Methods: Small-bore feeding tubes that increase in diameter over their length, were evaluated relative to current (constant diameter) tubes to determine if a tapered tube design could reduce the pressure required to clear an established clog in benchtop testing at pressures representative of those achieved safely in the clinical environment.\u0000 Results: Incorporating a tapered design into an 8F nasal feeding tube significantly reduced the pressure to expel an established clog by 62% (p < 0.05; 258.6 kPa vs. 710.8 kPa, respectively).\u0000 Conclusion: When compared to constant diameter tubes with the same proximal outside diameter, a tapered tube design permits clearance of an established clog at lower pressure.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"1 1","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41565019","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}
This paper presents the design, analysis, and fabrication of a capacitive-based three-axis force sensor as the building block of a wearable sensing system to directly measure all the components of three-dimensional (3D) ground reaction forces (3D GRFs) during walking. The proposed sensor is low-cost and easy to fabricate with high accuracy, which promotes its accessibility and usability for gait analysis in clinical and research settings. The sensor is comprised of only three parallel capacitors that enable three-axial force measurement while significantly reducing the complexity of fabrication and maintenance prevalent in three-axis force sensors. Comprehensive experiments were conducted to rigorously quantify different aspects of the sensor's performance. The static and dynamic errors along the three axes are less than 2.28%, which is well within the acceptable range for the intended application. The force sensor can decouple three-axial forces with a cross-sensitivity of less than 2%. The developed sensor also demonstrates desirable repeatability and hysteresis behaviors with almost no drift over long periods of usage.
{"title":"A Low-Cost Three-Axis Force Sensor for Wearable Gait Analysis Systems","authors":"Md Shafiqur Rahman, B. Hejrati","doi":"10.1115/1.4053725","DOIUrl":"https://doi.org/10.1115/1.4053725","url":null,"abstract":"\u0000 This paper presents the design, analysis, and fabrication of a capacitive-based three-axis force sensor as the building block of a wearable sensing system to directly measure all the components of three-dimensional (3D) ground reaction forces (3D GRFs) during walking. The proposed sensor is low-cost and easy to fabricate with high accuracy, which promotes its accessibility and usability for gait analysis in clinical and research settings. The sensor is comprised of only three parallel capacitors that enable three-axial force measurement while significantly reducing the complexity of fabrication and maintenance prevalent in three-axis force sensors. Comprehensive experiments were conducted to rigorously quantify different aspects of the sensor's performance. The static and dynamic errors along the three axes are less than 2.28%, which is well within the acceptable range for the intended application. The force sensor can decouple three-axial forces with a cross-sensitivity of less than 2%. The developed sensor also demonstrates desirable repeatability and hysteresis behaviors with almost no drift over long periods of usage.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44888645","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}
Risk assessment is a critical step in the roadmap of medical device development. Failure modes, effects and criticality analysis is a common approach based on declarative prior information that proved beneficial in the risk assessment of well established processes. But at early steps of development when innovative materials or technologies are embedded, the lack of experience on those innovations introduces too much subjectivity in FMECA for a robust risk assessment. Since mid-2000, the Quality-by-Design guideline has been proposed within the pharmaceutical industry as a proactive engineering approach of drug development. This paradigm enables a data-driven risk assessment throughout the development workflow, which completes risk assessment provided by FMECA. Nevertheless, its implementation guide is unclear and not flexible enough to be efficiently applied to the development of medical devices. To address this issue, a new QbD paradigm indexed on the technological readiness level of the innovative product is proposed. It covers the development of medical devices throughout the whole preclinical phase and is composed of at least nine learning cycles. The first part of this medical device QbD layout, composed of three consecutive risk assessment cycles, is evaluated through a real study case with the objective to demonstrate the proof of concept of a photobleaching controller in photodynamic therapy. Beyond this experimental result, this application has confirmed practical ability of the iQbD approach to complete FMECA and to provide an alternative solution to risk assessment when prior knowledge on the technological innovation is not available.
{"title":"iQbD: a TRL-indexed Quality-by-Design Paradigm for Medical Device Engineering","authors":"T. Bastogne","doi":"10.1115/1.4053721","DOIUrl":"https://doi.org/10.1115/1.4053721","url":null,"abstract":"\u0000 Risk assessment is a critical step in the roadmap of medical device development. Failure modes, effects and criticality analysis is a common approach based on declarative prior information that proved beneficial in the risk assessment of well established processes. But at early steps of development when innovative materials or technologies are embedded, the lack of experience on those innovations introduces too much subjectivity in FMECA for a robust risk assessment. Since mid-2000, the Quality-by-Design guideline has been proposed within the pharmaceutical industry as a proactive engineering approach of drug development. This paradigm enables a data-driven risk assessment throughout the development workflow, which completes risk assessment provided by FMECA. Nevertheless, its implementation guide is unclear and not flexible enough to be efficiently applied to the development of medical devices. To address this issue, a new QbD paradigm indexed on the technological readiness level of the innovative product is proposed. It covers the development of medical devices throughout the whole preclinical phase and is composed of at least nine learning cycles. The first part of this medical device QbD layout, composed of three consecutive risk assessment cycles, is evaluated through a real study case with the objective to demonstrate the proof of concept of a photobleaching controller in photodynamic therapy. Beyond this experimental result, this application has confirmed practical ability of the iQbD approach to complete FMECA and to provide an alternative solution to risk assessment when prior knowledge on the technological innovation is not available.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49177481","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}
After a median sternotomy, the sternal bone has to be refixated using implants such as wires, plates or clamps. However, there is still a lack of specifically applicable test methods to investigate the mechanical safety and effectiveness of such implant systems. The aim of this study was to develop a new test method that replicates the in vivo loads acting on the sternum and that is applicable to all types of sternal closure systems. Based on the scientific literature a setup was developed that incorporates the physiological loads acting on the sternum during breathing (91 N) and coughing (328 N). These loads are applied to a sternum replicate at 5 Hz for approximately 1.8 million cycles. This cycle number is assumed to represent the healing period. For validation, the new method was applied to two different sternal closure systems: a PEEK clamp system and wires. The new test method proved to be easily applicable. The validation tests with the two sternal closure systems showed reasonable and reproducible results regarding all outcome parameters. The pre-tension exerted by the implants significantly differed between the two implant groups and decreased after the first coughing cycles. The fracture gap separation during breathing also significantly different between the two test groups but it was similar during coughing. No implant failed. Using this new test method it is possible to compare sternal closure systems under reproducible conditions and interpret their mechanical characteristics regarding their in vivo safety and effectiveness.
{"title":"Development and Validation of a Physiological Testing Method for Sternal Closure Systems","authors":"Annette Kienle, Nadine Renner, Constanze Bischoff","doi":"10.1115/1.4053687","DOIUrl":"https://doi.org/10.1115/1.4053687","url":null,"abstract":"\u0000 After a median sternotomy, the sternal bone has to be refixated using implants such as wires, plates or clamps. However, there is still a lack of specifically applicable test methods to investigate the mechanical safety and effectiveness of such implant systems. The aim of this study was to develop a new test method that replicates the in vivo loads acting on the sternum and that is applicable to all types of sternal closure systems.\u0000 Based on the scientific literature a setup was developed that incorporates the physiological loads acting on the sternum during breathing (91 N) and coughing (328 N). These loads are applied to a sternum replicate at 5 Hz for approximately 1.8 million cycles. This cycle number is assumed to represent the healing period. For validation, the new method was applied to two different sternal closure systems: a PEEK clamp system and wires.\u0000 The new test method proved to be easily applicable. The validation tests with the two sternal closure systems showed reasonable and reproducible results regarding all outcome parameters. The pre-tension exerted by the implants significantly differed between the two implant groups and decreased after the first coughing cycles. The fracture gap separation during breathing also significantly different between the two test groups but it was similar during coughing. No implant failed.\u0000 Using this new test method it is possible to compare sternal closure systems under reproducible conditions and interpret their mechanical characteristics regarding their in vivo safety and effectiveness.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46816216","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}
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