Robotic devices are commonly used in surgical simulators to provide tactile, or haptic, feedback. They can provide customized feedback that can be rapidly modified with minimal hardware changes in comparison to non-robotic systems. This work describes the design, development, and evaluation of one such tool: a novel uniaxial torque haptic device for a surgical training simulator. The objective of the work was to design a single connection haptic device that could augment an existing six degree of freedom haptic device to mimic a Concorde Clear vacuum curette. Design and evaluations focused on the tool's ability to deliver adequate torque, imitate a surgical tool, and be integrated into the haptic device. Twenty-nine surgeons tested the tool in the simulator and evaluated it via a questionnaire. The device was found to deliver the 800 N·mm of torque necessary to mimic an orthopedic procedure. Surgeons found it accurately imitated surgical tool physical appearance and maneuverability, scoring them 3.9±1.0 and 3.3±1.2, respectively, on a 1-5 Likert scale. By virtue of the functionality necessary for testing and evaluation, the device could be connected to the haptic device for mechanical and electrical engagement. This device is a step forward in the field of augmentable haptic devices for surgical simulation. By changing the number of robotically-controlled degrees of freedom of a haptic device, existing devices can be tuned to meet the demands of a particular simulator, which has the potential to improve surgeon training standards.
{"title":"Design Synthesis of a Robotic Uniaxial Torque Device for Orthopedic Haptic Simulation","authors":"T. Cotter, R. Mongrain, Mark Driscoll","doi":"10.1115/1.4054344","DOIUrl":"https://doi.org/10.1115/1.4054344","url":null,"abstract":"\u0000 Robotic devices are commonly used in surgical simulators to provide tactile, or haptic, feedback. They can provide customized feedback that can be rapidly modified with minimal hardware changes in comparison to non-robotic systems. This work describes the design, development, and evaluation of one such tool: a novel uniaxial torque haptic device for a surgical training simulator. The objective of the work was to design a single connection haptic device that could augment an existing six degree of freedom haptic device to mimic a Concorde Clear vacuum curette. Design and evaluations focused on the tool's ability to deliver adequate torque, imitate a surgical tool, and be integrated into the haptic device. Twenty-nine surgeons tested the tool in the simulator and evaluated it via a questionnaire. The device was found to deliver the 800 N·mm of torque necessary to mimic an orthopedic procedure. Surgeons found it accurately imitated surgical tool physical appearance and maneuverability, scoring them 3.9±1.0 and 3.3±1.2, respectively, on a 1-5 Likert scale. By virtue of the functionality necessary for testing and evaluation, the device could be connected to the haptic device for mechanical and electrical engagement. This device is a step forward in the field of augmentable haptic devices for surgical simulation. By changing the number of robotically-controlled degrees of freedom of a haptic device, existing devices can be tuned to meet the demands of a particular simulator, which has the potential to improve surgeon training standards.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48506893","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}
Background: The continuum over tube applied to natural orifice transluminal endoscopic surgery (NOTES) should be flexible during insertion and provide sufficient stiffness upon arrival at the lesion. In order to satisfy these two properties, a variable stiffness continuum over tube was proposed. Method: The over tube realizes stiffness variation through the heating and cooling of filling materials. Polyethylene glycol, cocoa butter and gallium metal are selected as filling materials. Several experiments were designed to test its rigid and response characteristic and suitable material was selected. The risk management test was carried out, and the frequency and risk level of the risk point was recorded. Results: According to experimental data, the polyethylene glycol and gallium shows better variable stiffness performance, with the 20 times stiffness variation range, and polyethylene glycol was selected as suitable materials for its low cost and non-toxic characteristic. The average heating time and cooling time of polyethylene glycol-filled over tube are 52.3s and 36s respectively. Moreover, three kinds of high frequency risk points including smoke, thread ejection and uneven distribution of the material were found, and corresponding design improvement and use principle are proposed. Conclusion: The proposed continuum over tube can satisfy the requirement of colorectal NOTES, and the safety of the instrument can be improved by controlling high frequency risk points with relevant methods.
{"title":"A Continuum Over Tube with Variable Stiffness for Transrectal Notes","authors":"Jinhua Li, Lan Zhang, Yuan Xing, R. Liu","doi":"10.1115/1.4054343","DOIUrl":"https://doi.org/10.1115/1.4054343","url":null,"abstract":"\u0000 Background: The continuum over tube applied to natural orifice transluminal endoscopic surgery (NOTES) should be flexible during insertion and provide sufficient stiffness upon arrival at the lesion. In order to satisfy these two properties, a variable stiffness continuum over tube was proposed.\u0000 Method: The over tube realizes stiffness variation through the heating and cooling of filling materials. Polyethylene glycol, cocoa butter and gallium metal are selected as filling materials. Several experiments were designed to test its rigid and response characteristic and suitable material was selected. The risk management test was carried out, and the frequency and risk level of the risk point was recorded.\u0000 Results: According to experimental data, the polyethylene glycol and gallium shows better variable stiffness performance, with the 20 times stiffness variation range, and polyethylene glycol was selected as suitable materials for its low cost and non-toxic characteristic. The average heating time and cooling time of polyethylene glycol-filled over tube are 52.3s and 36s respectively. Moreover, three kinds of high frequency risk points including smoke, thread ejection and uneven distribution of the material were found, and corresponding design improvement and use principle are proposed.\u0000 Conclusion: The proposed continuum over tube can satisfy the requirement of colorectal NOTES, and the safety of the instrument can be improved by controlling high frequency risk points with relevant methods.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46147740","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}
Marianna J. Coulentianos, Ilka Rodriguez-Calero, S. Daly, Jocelyn Burridge, K. Sienko
Successful medical device design entails an understanding of stakeholder-driven requirements early in the process to assure device safety and usability and support successful and positive patient experiences. Prototypes can be used during stakeholder engagement in the design front end to gather information to inform design decisions. However, an understanding of medical device industry practices of front-end stakeholder engagement with prototypes is lacking. Through interviews with medical device design practitioners, this study explored the variety of stakeholder groups engaged by design practitioners, prototype types used during stakeholder engagements, and settings in which engagements took place during front-end design activities. This study describes the 14 types of stakeholders, 14 types of prototypes, and six types of settings described by practitioners as well as patterns across engagement strategies, stakeholders, prototypes, and/or settings in front-end activities. These outcomes can contribute to broadening designers' stakeholder engagement planning and practices.
{"title":"Stakeholders, Prototypes, and Settings of Front-End Medical Device Design Activities","authors":"Marianna J. Coulentianos, Ilka Rodriguez-Calero, S. Daly, Jocelyn Burridge, K. Sienko","doi":"10.1115/1.4054207","DOIUrl":"https://doi.org/10.1115/1.4054207","url":null,"abstract":"\u0000 Successful medical device design entails an understanding of stakeholder-driven requirements early in the process to assure device safety and usability and support successful and positive patient experiences. Prototypes can be used during stakeholder engagement in the design front end to gather information to inform design decisions. However, an understanding of medical device industry practices of front-end stakeholder engagement with prototypes is lacking. Through interviews with medical device design practitioners, this study explored the variety of stakeholder groups engaged by design practitioners, prototype types used during stakeholder engagements, and settings in which engagements took place during front-end design activities. This study describes the 14 types of stakeholders, 14 types of prototypes, and six types of settings described by practitioners as well as patterns across engagement strategies, stakeholders, prototypes, and/or settings in front-end activities. These outcomes can contribute to broadening designers' stakeholder engagement planning and practices.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46521970","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}
Complications after transcatheter closure of the ventricular septal defect (VSD) is significantly associated with the mechanical behaviour of the VSD occluder. This study aims to investigate the effect of structural parameters of the VSD occluder. A mechanical model of the VSD occluder was constructed by theoretical modelling. The mechanical properties of the VSD occluders with different braiding angles (30°, 45°, 60°), materials (nitinol (NiTi), polydioxanone (PDO)) and waist-heights (3 mm, 4 mm) were analysed and validated by bench tests. For the 30°NiTi, 45°NiTi, 60°NiTi and 45°PDO occluders, the bending angles at the waist under 1 mm radial shrinkage were 112°, 121°, 155° and 155°, respectively. And the maximum principal strains at the waist were 16.62%, 8.19%, 1.20%, and 0.66%, respectively. The maximum radial deformations with 0.5 rad axial bending at the waist were 1.73, 1.44, 0.41 and 1.68 mm, respectively. When the occluders were implanted into VSD with the mean thickness of 3.5 mm, high stress appeared at the margin and the contact area, and the area with the 3-mm-occluder was much larger. In conclusion, the 60°NiTi occluder showed better ability to fit the deformation of the defect than the other NiTi occluders, and the 45°PDO occluder performed better under compression conditions but poorly under bending conditions than the 45°NiTi occluder. The choice of the appropriate waist-height is beneficial to eliminate associative complication by reducing the contact stress.
{"title":"Finite Element Analysis and Bench Testing of Ventricular Septal Defect Occluder","authors":"Yiming Li, Chengli Song, Kun Sun","doi":"10.1115/1.4054082","DOIUrl":"https://doi.org/10.1115/1.4054082","url":null,"abstract":"\u0000 Complications after transcatheter closure of the ventricular septal defect (VSD) is significantly associated with the mechanical behaviour of the VSD occluder. This study aims to investigate the effect of structural parameters of the VSD occluder. A mechanical model of the VSD occluder was constructed by theoretical modelling. The mechanical properties of the VSD occluders with different braiding angles (30°, 45°, 60°), materials (nitinol (NiTi), polydioxanone (PDO)) and waist-heights (3 mm, 4 mm) were analysed and validated by bench tests. For the 30°NiTi, 45°NiTi, 60°NiTi and 45°PDO occluders, the bending angles at the waist under 1 mm radial shrinkage were 112°, 121°, 155° and 155°, respectively. And the maximum principal strains at the waist were 16.62%, 8.19%, 1.20%, and 0.66%, respectively. The maximum radial deformations with 0.5 rad axial bending at the waist were 1.73, 1.44, 0.41 and 1.68 mm, respectively. When the occluders were implanted into VSD with the mean thickness of 3.5 mm, high stress appeared at the margin and the contact area, and the area with the 3-mm-occluder was much larger. In conclusion, the 60°NiTi occluder showed better ability to fit the deformation of the defect than the other NiTi occluders, and the 45°PDO occluder performed better under compression conditions but poorly under bending conditions than the 45°NiTi occluder. The choice of the appropriate waist-height is beneficial to eliminate associative complication by reducing the contact stress.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41782796","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}
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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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}
Linsey Griffin, Minji Yu, Alison Cloet, Susan Arnold, Neil Carlson, Marc Hillmyer, Qisheng Ou, Chenxing Pei, Qingfeng Cao, David Pui, Rhonda Franklin, William Durfee
At the beginning of the COVID-19 pandemic when traditional N95 respirators were in short supply in the United States, there was a need for alternative products that did not rely on traditional avenues of sourcing and manufacturing. The purpose of this research was to develop and test alternatives to N95 respirators that could be produced locally without specialized materials and processes. Through an interdisciplinary team of experts, new mask designs that use repurposed filtration media and commercially available components were developed and tested for filtration and fit against current N95 standards. Filtration efficiency test results showed that the filtration media can be used for high-quality facemasks and quantitative fit testing demonstrated that the new mask designs could be viable alternatives to traditional N95 facemasks when those masks are in short supply. Manufacturing viability was tested utilizing a workforce to create 6000 masks over 10 days. The ability to quickly produce masks at scale using a workforce without specialized skills demonstrated the feasibility of the mask designs and manufacturing approach to address shortages of critical healthcare equipment, mitigate risk for healthcare and essential workers, and minimize the transmission and spread of disease.
{"title":"Protective Masks Utilizing Nonendangered Components.","authors":"Linsey Griffin, Minji Yu, Alison Cloet, Susan Arnold, Neil Carlson, Marc Hillmyer, Qisheng Ou, Chenxing Pei, Qingfeng Cao, David Pui, Rhonda Franklin, William Durfee","doi":"10.1115/1.4053720","DOIUrl":"https://doi.org/10.1115/1.4053720","url":null,"abstract":"<p><p>At the beginning of the COVID-19 pandemic when traditional N95 respirators were in short supply in the United States, there was a need for alternative products that did not rely on traditional avenues of sourcing and manufacturing. The purpose of this research was to develop and test alternatives to N95 respirators that could be produced locally without specialized materials and processes. Through an interdisciplinary team of experts, new mask designs that use repurposed filtration media and commercially available components were developed and tested for filtration and fit against current N95 standards. Filtration efficiency test results showed that the filtration media can be used for high-quality facemasks and quantitative fit testing demonstrated that the new mask designs could be viable alternatives to traditional N95 facemasks when those masks are in short supply. Manufacturing viability was tested utilizing a workforce to create 6000 masks over 10 days. The ability to quickly produce masks at scale using a workforce without specialized skills demonstrated the feasibility of the mask designs and manufacturing approach to address shortages of critical healthcare equipment, mitigate risk for healthcare and essential workers, and minimize the transmission and spread of disease.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905092/pdf/med-21-1189_015001.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10800334","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}
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.
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