Needle insertion is a common procedure in percutaneous puncture. A motion planner for a steerable needle that considers the risk level of the path in anatomical environment and the actual deflection of clinical needle is necessary. A novel preoperative motion planner for a steerable needle controlled by robot is proposed. Our method utilizes sampling-based planner to compute candidate path in the reachable region, the path solutions are optimized by calculating the cost of a path based on a cost map. The cost-map, which is built based on repulsive field theory from CT image, encodes the information of the obstacle locations and the criticality of the anatomical environment. The empirical formula that can predict needle trajectory is obtained by insertion experiments. Experiments shown that positioning error in gelatin phantom under the guidance of our planner is less than 1.1mm. Comparing with the straight-line insertion method, the positioning error was reduced by 80%. The results indicate that the motion planner has the potential to provide effective guidance for robot-assisted puncture surgery while enhancing the position precision and patient safety.
{"title":"Preoperative Motion Planner for Steerable Needles Using Cost Map Based on Repulsive Field and Empirical Model of Needle Deflection","authors":"Shan Jiang, Bowen Jiang, Peina Fang, Zhiyong Yang","doi":"10.1115/1.4053285","DOIUrl":"https://doi.org/10.1115/1.4053285","url":null,"abstract":"\u0000 Needle insertion is a common procedure in percutaneous puncture. A motion planner for a steerable needle that considers the risk level of the path in anatomical environment and the actual deflection of clinical needle is necessary. A novel preoperative motion planner for a steerable needle controlled by robot is proposed. Our method utilizes sampling-based planner to compute candidate path in the reachable region, the path solutions are optimized by calculating the cost of a path based on a cost map. The cost-map, which is built based on repulsive field theory from CT image, encodes the information of the obstacle locations and the criticality of the anatomical environment. The empirical formula that can predict needle trajectory is obtained by insertion experiments. Experiments shown that positioning error in gelatin phantom under the guidance of our planner is less than 1.1mm. Comparing with the straight-line insertion method, the positioning error was reduced by 80%. The results indicate that the motion planner has the potential to provide effective guidance for robot-assisted puncture surgery while enhancing the position precision and patient safety.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41636267","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}
Toby Elery, Emma Reznick, Staci M. Shearin, Karen J. McCain, R. Gregg
This paper presents the novel design of a Multi-Degree-Of-Freedom joint (M-DOF) for an Ankle-Foot Orthosis (AFO) that aims to improve upon the commercially available Double Action Joint (DAJ). The M-DOF is designed to maintain the functionality of the DAJ, while increasing dorsiflexion stiffness and introducing inversion/eversion. This increase in range of motion is designed to produce greater engagement from lower limb muscles during gait. The M-DOF was experimentally validated with one able-bodied and one stroke subject. Across walking speeds, the M-DOF AFO minimally affected the able-bodied subject's joint kinematics. The stroke subject's ankle dorsiflexion/plantarflexion and knee flexion were not heavily altered when wearing the M-DOF AFO, compared to the DAJ AFO. The new DOF allowed by the M-DOF AFO increased the inversion/eversion of the ankle by ~3°, without introducing any new compensations compared to their gait with the DAJ AFO.
{"title":"Design and Initial Validation of a Multiple Degree-of-Freedom Joint for an Ankle-Foot Orthosis","authors":"Toby Elery, Emma Reznick, Staci M. Shearin, Karen J. McCain, R. Gregg","doi":"10.1115/1.4053200","DOIUrl":"https://doi.org/10.1115/1.4053200","url":null,"abstract":"\u0000 This paper presents the novel design of a Multi-Degree-Of-Freedom joint (M-DOF) for an Ankle-Foot Orthosis (AFO) that aims to improve upon the commercially available Double Action Joint (DAJ). The M-DOF is designed to maintain the functionality of the DAJ, while increasing dorsiflexion stiffness and introducing inversion/eversion. This increase in range of motion is designed to produce greater engagement from lower limb muscles during gait. The M-DOF was experimentally validated with one able-bodied and one stroke subject. Across walking speeds, the M-DOF AFO minimally affected the able-bodied subject's joint kinematics. The stroke subject's ankle dorsiflexion/plantarflexion and knee flexion were not heavily altered when wearing the M-DOF AFO, compared to the DAJ AFO. The new DOF allowed by the M-DOF AFO increased the inversion/eversion of the ankle by ~3°, without introducing any new compensations compared to their gait with the DAJ AFO.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42563413","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}
Justin Brooks, C. Feltch, J. Lam, C. Earley, R. Robucci, Sanjay Agarwal, Nilanjan Banerjee
Several sleep disorders are characterized by periodic leg movements during sleep including Restless Leg Syndrome, and can indicate disrupted sleep in otherwise healthy individuals. Current technologies to measure periodic leg movements during sleep are limited. Polysomnography and some home sleep tests use surface electromyography to measure electrical activity from the anterior tibilias muscle. Actigraphy uses 3-axis accelerometers to measure movement of the ankle. Electromyography misses periodic leg movements that involve other leg muscles and is obtrusive because of the wires needed to carry the signal. Actigraphy based devices require large amplitude movements of the ankle to detect leg movements (missing the significant number of more subtle leg movements) and can be worn in multiple configurations precluding precision measurement. These limitations have contributed to their lack of adoption as a standard of care for several sleep disorders. In this study, we develop the RestEaze sleep assessment tool as an ankle-worn wearable device that combines capacitive sensors and a 6-axis inertial measurement unit to precisely measure periodic leg movements during sleep. This unique combination of sensors and the form-factor of the device addresses current limitations of periodic leg movements during sleep measurement techniques. Pilot data collected shows high correlation with polysomnography across a heterogeneous participant sample and high usability ratings. RestEaze shows promise in providing ecologically valid, longitudinal measures of leg movements that will be useful for clinicians, researchers, and patients to better understand sleep.
{"title":"RestEaze: An Emerging Technology to Characterize Leg Movements During Sleep","authors":"Justin Brooks, C. Feltch, J. Lam, C. Earley, R. Robucci, Sanjay Agarwal, Nilanjan Banerjee","doi":"10.1115/1.4053160","DOIUrl":"https://doi.org/10.1115/1.4053160","url":null,"abstract":"\u0000 Several sleep disorders are characterized by periodic leg movements during sleep including Restless Leg Syndrome, and can indicate disrupted sleep in otherwise healthy individuals. Current technologies to measure periodic leg movements during sleep are limited. Polysomnography and some home sleep tests use surface electromyography to measure electrical activity from the anterior tibilias muscle. Actigraphy uses 3-axis accelerometers to measure movement of the ankle. Electromyography misses periodic leg movements that involve other leg muscles and is obtrusive because of the wires needed to carry the signal. Actigraphy based devices require large amplitude movements of the ankle to detect leg movements (missing the significant number of more subtle leg movements) and can be worn in multiple configurations precluding precision measurement. These limitations have contributed to their lack of adoption as a standard of care for several sleep disorders. In this study, we develop the RestEaze sleep assessment tool as an ankle-worn wearable device that combines capacitive sensors and a 6-axis inertial measurement unit to precisely measure periodic leg movements during sleep. This unique combination of sensors and the form-factor of the device addresses current limitations of periodic leg movements during sleep measurement techniques. Pilot data collected shows high correlation with polysomnography across a heterogeneous participant sample and high usability ratings. RestEaze shows promise in providing ecologically valid, longitudinal measures of leg movements that will be useful for clinicians, researchers, and patients to better understand sleep.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43134886","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}
D. I. Mahcicek, Korel D. Yildirim, Gokce Kasaci, O. Kocaturk
In clinical routine, the prostate biopsy procedure is performed with the guidance of transrectal ultrasound (TRUS) imaging to diagnose prostate cancer. However, the TRUS-guided prostate biopsy brings reliability concerns due to the lack of contrast difference between prostate tissue and lesions. In this study, a novel hydraulic needle delivery system that is designed for performing magnetic resonance imaging (MRI)-guided prostate biopsy procedure with transperineal approach is introduced. The feasibility of the overall system was evaluated through in vitro phantom experiments under an MRI guidance. The in vitro experiments performed using a certified prostate phantom (incorporating MRI visible lesions). MRI experiments showed that overall hydraulic biopsy needle delivery system has excellent MRI compatibility (signal to noise ratio (SNR) loss < 3%), provides acceptable targeting accuracy (average 2.05±0.46 mm) and procedure time (average 40 min).
{"title":"Preliminary Evaluation of Hydraulic Needle Delivery System for Magnetic Resonance Imaging-Guided Prostate Biopsy Procedures","authors":"D. I. Mahcicek, Korel D. Yildirim, Gokce Kasaci, O. Kocaturk","doi":"10.1115/1.4051610","DOIUrl":"https://doi.org/10.1115/1.4051610","url":null,"abstract":"\u0000 In clinical routine, the prostate biopsy procedure is performed with the guidance of transrectal ultrasound (TRUS) imaging to diagnose prostate cancer. However, the TRUS-guided prostate biopsy brings reliability concerns due to the lack of contrast difference between prostate tissue and lesions. In this study, a novel hydraulic needle delivery system that is designed for performing magnetic resonance imaging (MRI)-guided prostate biopsy procedure with transperineal approach is introduced. The feasibility of the overall system was evaluated through in vitro phantom experiments under an MRI guidance. The in vitro experiments performed using a certified prostate phantom (incorporating MRI visible lesions). MRI experiments showed that overall hydraulic biopsy needle delivery system has excellent MRI compatibility (signal to noise ratio (SNR) loss < 3%), provides acceptable targeting accuracy (average 2.05±0.46 mm) and procedure time (average 40 min).","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43372231","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}
Orthotic treatments for knee osteoarthritis (OA) typically rely on simple mechanisms such as three-point bending straps and single-pin hinges. These commonly prescribed braces cannot treat bicompartmental knee OA, do not consider the muscle weakness that typically accompanies the condition, and employ hinges that restrict the knee's natural biomechanics. Utilizing a novel, personalized joint mechanism in conjunction with magnetorheological dampers, we have developed and evaluated a brace which attempts to address these shortcomings. This process has respected three principal design goals: reducing the load experienced across the entire knee joint, generating a supportive moment to aid the thigh muscles in shock absorption, and interfering minimally with gait kinematics. Two healthy volunteers were chosen to test the system's basic functionality through gait analysis in a motion capture laboratory. Combining the collected kinematic and force-plate data with data taken from sensors onboard the brace, we integrated the brace and leg system into a single inverse dynamics analysis, from which we were able to evaluate the effect of the brace design on the subjects' knee loads and moments. Of the three design goals: a reduction in knee contact forces was demonstrated; increased shock absorption was observed, but not to statistical significance; and natural gait was largely preserved. Taken in total, the outcome of this study supports additional investigation into the system's clinical effectiveness, and suggests that further refinement of the techniques presented in this paper could open the doors to more effective OA treatment through patient specific braces.
{"title":"Functional Evaluation of a Personalized Orthosis for Knee Osteoarthritis: A Motion Capture Analysis","authors":"M. Huber, M. Eschbach, K. Kazerounian, H. Ilies","doi":"10.1115/1.4051626","DOIUrl":"https://doi.org/10.1115/1.4051626","url":null,"abstract":"\u0000 Orthotic treatments for knee osteoarthritis (OA) typically rely on simple mechanisms such as three-point bending straps and single-pin hinges. These commonly prescribed braces cannot treat bicompartmental knee OA, do not consider the muscle weakness that typically accompanies the condition, and employ hinges that restrict the knee's natural biomechanics. Utilizing a novel, personalized joint mechanism in conjunction with magnetorheological dampers, we have developed and evaluated a brace which attempts to address these shortcomings. This process has respected three principal design goals: reducing the load experienced across the entire knee joint, generating a supportive moment to aid the thigh muscles in shock absorption, and interfering minimally with gait kinematics. Two healthy volunteers were chosen to test the system's basic functionality through gait analysis in a motion capture laboratory. Combining the collected kinematic and force-plate data with data taken from sensors onboard the brace, we integrated the brace and leg system into a single inverse dynamics analysis, from which we were able to evaluate the effect of the brace design on the subjects' knee loads and moments. Of the three design goals: a reduction in knee contact forces was demonstrated; increased shock absorption was observed, but not to statistical significance; and natural gait was largely preserved. Taken in total, the outcome of this study supports additional investigation into the system's clinical effectiveness, and suggests that further refinement of the techniques presented in this paper could open the doors to more effective OA treatment through patient specific braces.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41475684","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}
C. Christianson, K. Pillay, John Z Chen, W. Finlay, Andrew R. Martin
Portable oxygen concentrators (POCs) are widely used to administer long-term oxygen therapy (LTOT) and employ pulsed delivery modes to conserve oxygen. Efficient pulsed delivery requires that POCs are triggered by patient inhalation. Triggering is known to fail for some patients during periods of quite breathing, as occurs during sleep. The present article describes a new nasal interface designed to improve triggering of pulsed oxygen delivery from portable oxygen concentrators (POCs). In vitro experiments incorporating realistic nasal airway replicas and simulated breathing were conducted. The pressure monitored via oxygen supply tubing (the signal pressure) was measured over a range of constant inhalation flow rates with the nasal interface inserted into the nares of the nasal airway replicas, and compared with signal pressures measured for standard and flared nasal cannulas. Triggering efficiency and the fraction of inhaled oxygen (FiO2) were then evaluated for the nasal interface and cannulas used with a commercial POC during simulated tidal breathing through the replicas. Higher signal pressures were achieved for the nasal interface than for nasal cannulas at all flow rates studied. The nasal interface triggered pulsed delivery from the POC in cases where nasal cannulas failed to trigger. FiO2 was significantly higher for successful triggering cases than for failed triggering cases. The nasal interface improved triggering of pulsed oxygen delivery from a POC and presents a simple solution that could be used with commercially-available POCs to reliably supply oxygen during periods of quiet breathing.
{"title":"In Vitro Evaluation of a Nasal Interface Used to Improve Delivery from a Portable Oxygen Concentrator","authors":"C. Christianson, K. Pillay, John Z Chen, W. Finlay, Andrew R. Martin","doi":"10.1115/1.4053115","DOIUrl":"https://doi.org/10.1115/1.4053115","url":null,"abstract":"\u0000 Portable oxygen concentrators (POCs) are widely used to administer long-term oxygen therapy (LTOT) and employ pulsed delivery modes to conserve oxygen. Efficient pulsed delivery requires that POCs are triggered by patient inhalation. Triggering is known to fail for some patients during periods of quite breathing, as occurs during sleep. The present article describes a new nasal interface designed to improve triggering of pulsed oxygen delivery from portable oxygen concentrators (POCs). In vitro experiments incorporating realistic nasal airway replicas and simulated breathing were conducted. The pressure monitored via oxygen supply tubing (the signal pressure) was measured over a range of constant inhalation flow rates with the nasal interface inserted into the nares of the nasal airway replicas, and compared with signal pressures measured for standard and flared nasal cannulas. Triggering efficiency and the fraction of inhaled oxygen (FiO2) were then evaluated for the nasal interface and cannulas used with a commercial POC during simulated tidal breathing through the replicas. Higher signal pressures were achieved for the nasal interface than for nasal cannulas at all flow rates studied. The nasal interface triggered pulsed delivery from the POC in cases where nasal cannulas failed to trigger. FiO2 was significantly higher for successful triggering cases than for failed triggering cases. The nasal interface improved triggering of pulsed oxygen delivery from a POC and presents a simple solution that could be used with commercially-available POCs to reliably supply oxygen during periods of quiet breathing.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47366711","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}
Hamed Mohammadbagherpoor, Alperen Acemoglu, L. Mattos, D. Caldwell, James J. Johnson, J. Muth, E. Grant
Biomedical robotic systems continue to hold unlimited potential for surgical procedures. Robotized laser endoscopic tools provide surgeons with increased accuracy in the laser ablation of tissue and tumors. The research here catalogs the design and implementation of a new laser endoscopic tool for tissue ablation. A novel feature of this new device is the inclusion of a feedback loop that measures the position of the laser beam via a photo-detector sensor. The scale of this new device was governed by the dimensions of the photo-detector sensor. The tip of the laser's fiber optic cable is controlled by the torque interaction between permanent magnet rings surrounding the fiber optic and the custom designed solenoid coils. Prior to building the physical test-bed the system was modeled and simulated using COMSOL software. In pre-clinical trials, the physical experimental results showed that the designed prototype laser scanner system accurately track different ablation patterns and gives a consistent output position for the laser beam however, the heat diffusion into the tissue around the desired line of the geometric shape would give wider ablation margins than was desirable.
{"title":"Designing and Testing a Closed-loop Magnetically Actuated Laser Scanning System for Tissue Ablation","authors":"Hamed Mohammadbagherpoor, Alperen Acemoglu, L. Mattos, D. Caldwell, James J. Johnson, J. Muth, E. Grant","doi":"10.1115/1.4053073","DOIUrl":"https://doi.org/10.1115/1.4053073","url":null,"abstract":"\u0000 Biomedical robotic systems continue to hold unlimited potential for surgical procedures. Robotized laser endoscopic tools provide surgeons with increased accuracy in the laser ablation of tissue and tumors. The research here catalogs the design and implementation of a new laser endoscopic tool for tissue ablation. A novel feature of this new device is the inclusion of a feedback loop that measures the position of the laser beam via a photo-detector sensor. The scale of this new device was governed by the dimensions of the photo-detector sensor. The tip of the laser's fiber optic cable is controlled by the torque interaction between permanent magnet rings surrounding the fiber optic and the custom designed solenoid coils. Prior to building the physical test-bed the system was modeled and simulated using COMSOL software. In pre-clinical trials, the physical experimental results showed that the designed prototype laser scanner system accurately track different ablation patterns and gives a consistent output position for the laser beam however, the heat diffusion into the tissue around the desired line of the geometric shape would give wider ablation margins than was desirable.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42565241","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}
Beatrice Ncho, Andrew W. Siefert, V. Sadri, Jillian Ortner, A. Yoganathan
Transcatheter aortic valve replacement devices vary in leaflet material and in the height for which leaflets attach to the stented valve frame. Combinations of these features can influence leaflet dynamics, neo-sinus geometries, and fluid dynamics, thereby reducing or exacerbating the potential for blood flow stasis and leaflet thrombosis. To investigate these interconnected relationships, this study evaluated the effects of transcatheter valve leaflet type (porcine vs. bovine pericardium) and the leaflet-stent attachment height (low, mid, and high) on flow stasis and potential for leaflet thrombosis. Transcatheter valve models were manufactured and tested within an aortic simulator under pulsatile left heart hemodynamic conditions. Transvalvular hemodynamics, leaflet kinematics, and flow structures were evaluated by direct measurement, high-speed imaging, and two differing techniques of particle image velocimetry. Transcatheter valves with porcine pericardial leaflets were observed to be less stiff, exhibit a lesser resistance to flow, were associated with reduced regions of neo-sinus flow stasis, and superior sinus washout times. More elevated attachments of the leaflets were associated with less neo-sinus flow stasis. These initial results and observations suggest combinations of leaflet type and stent attachment height may reduce transcatheter aortic valve flow stasis and the potential for leaflet thrombosis.
{"title":"Effect of Leaflet Type and Leaflet-Stent Attachment Height on Transcatheter Aortic Valve Leaflet Thrombosis Potential","authors":"Beatrice Ncho, Andrew W. Siefert, V. Sadri, Jillian Ortner, A. Yoganathan","doi":"10.1115/1.4052902","DOIUrl":"https://doi.org/10.1115/1.4052902","url":null,"abstract":"\u0000 Transcatheter aortic valve replacement devices vary in leaflet material and in the height for which leaflets attach to the stented valve frame. Combinations of these features can influence leaflet dynamics, neo-sinus geometries, and fluid dynamics, thereby reducing or exacerbating the potential for blood flow stasis and leaflet thrombosis. To investigate these interconnected relationships, this study evaluated the effects of transcatheter valve leaflet type (porcine vs. bovine pericardium) and the leaflet-stent attachment height (low, mid, and high) on flow stasis and potential for leaflet thrombosis. Transcatheter valve models were manufactured and tested within an aortic simulator under pulsatile left heart hemodynamic conditions. Transvalvular hemodynamics, leaflet kinematics, and flow structures were evaluated by direct measurement, high-speed imaging, and two differing techniques of particle image velocimetry. Transcatheter valves with porcine pericardial leaflets were observed to be less stiff, exhibit a lesser resistance to flow, were associated with reduced regions of neo-sinus flow stasis, and superior sinus washout times. More elevated attachments of the leaflets were associated with less neo-sinus flow stasis. These initial results and observations suggest combinations of leaflet type and stent attachment height may reduce transcatheter aortic valve flow stasis and the potential for leaflet thrombosis.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45495826","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}
Carpal tunnel syndrome and tendonitis are two common upper extremity cumulative trauma disorders (CTD) related to repetitive and forceful activities in industrial environments. Reducing the muscular force during activities such as the operation of a pistol grip hand tool could result in lower incidence of CTDs. The objective of this research was to reduce the muscular contribution to the grip force using an active orthosis system. A novel soft, pneumatic grasp assist device, that used a unique design of sinusoidal bellows oriented at 45 degrees, was designed to augment the users' strength during operation of pistol grip hand tool. The optimized design was fabricated using rapid prototyping. Device effectiveness was quantified by measuring muscle activity and grip force during an in vivo study of a common industrial activity. Nine subjects experienced with power tools employed by an automobile manufacturer installed 18 fasteners using a pistol grip DC tool with and without the grasp assist device. Surface electromyography (sEMG) was used to measure the activity of four muscles commonly associated with grasping. Results showed that the grasp assist significantly reduced the mean, combined, normalized muscle activity by 18% (p<0.05). Muscle activation results were contextualized using the revised strain index (RSI). The grasp assist device trial yielded a significantly lower mean RSI value than the typical trial by 13% (p<0.05). The study showed that using an active grasp assist orthosis could reduce the incidence of CTDs in able bodied industrial workers using DC hand tools.
{"title":"Design and Preliminary Validation of Grasp Assistive Device for an Industrial Environment","authors":"Daniel Loewen, N. Chandrashekar","doi":"10.1115/1.4052899","DOIUrl":"https://doi.org/10.1115/1.4052899","url":null,"abstract":"\u0000 Carpal tunnel syndrome and tendonitis are two common upper extremity cumulative trauma disorders (CTD) related to repetitive and forceful activities in industrial environments. Reducing the muscular force during activities such as the operation of a pistol grip hand tool could result in lower incidence of CTDs. The objective of this research was to reduce the muscular contribution to the grip force using an active orthosis system. A novel soft, pneumatic grasp assist device, that used a unique design of sinusoidal bellows oriented at 45 degrees, was designed to augment the users' strength during operation of pistol grip hand tool. The optimized design was fabricated using rapid prototyping. Device effectiveness was quantified by measuring muscle activity and grip force during an in vivo study of a common industrial activity. Nine subjects experienced with power tools employed by an automobile manufacturer installed 18 fasteners using a pistol grip DC tool with and without the grasp assist device. Surface electromyography (sEMG) was used to measure the activity of four muscles commonly associated with grasping. Results showed that the grasp assist significantly reduced the mean, combined, normalized muscle activity by 18% (p<0.05). Muscle activation results were contextualized using the revised strain index (RSI). The grasp assist device trial yielded a significantly lower mean RSI value than the typical trial by 13% (p<0.05). The study showed that using an active grasp assist orthosis could reduce the incidence of CTDs in able bodied industrial workers using DC hand tools.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2021-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48043745","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}
A. Trulson, M. Küper, Artur Leis, U. Stöckle, F. Stuby, M. Hossfeld
Background: Recently presented minimally invasive endoscopic surgical techniques demonstrated the feasibility of implanting standard osteosynthesis plates for pelvic fractures. The reconstruction and internal fixation of complex acetabular fractures is still challenging. The goal of this study is to introduce a divisible implant, with a positive-locking in situ linking mechanism for plate osteosynthesis, making it possible to stabilize large and complex acetabular fractures with involvement of the quadrilateral surface. Method: Standard implants were used to recreate a base design. Using computer aided design (CAD), a three-dimensional standard implant was divided into two parts, so they could be re-allocated in situ. A critical objective was to reduce the cross-section of each part (clearance gauge). To connect the separated parts in situ, a new linking mechanism (cone in cone) was created. The new construct also features self-stabilization, self-centering, reinforced positional movement and preloading effects. Results: A linking system for plate osteosynthesis was developed entitled PEGASOS ("Percutaneous Endoscopic Guided Acetabulum-Stabilizing Osteosynthesis System"). Endoscopic implantation and in-situ-linking could be performed in a human cadaver. Therefore, we could demonstrate, that buttressing the quadrilateral surface of the acetabulum could be performed minimally invasive using a divisible suprapectineal buttress plate. Conclusion: We created a linking mechanism to couple two plates in situ. This mechanism enables an extremely strong, positive-locking connection, whereas its geometric shape allows for different relative movements during the locking procedure, with a single screw.
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