R. Pettys-Baker, N. Subash, J. Abel, Surbhi Shah, Brad Holschuh
On-body compressive therapy is an essential treatment for a variety of health conditions. Traditional compression methods like pneumatics and knit stockings offer quality compression, but present issues with user experience (donning/doffing challenges or bulk/mass issues). This paper covers two studies related to active compression stockings, which utilize knitted shape memory alloy (SMA) wire to produce dynamic compression forces on the body. When these SMA knit panels are heated with an at-home heating pad, the knit contracts and creates dynamic compression. The first study characterizes the forces produced on the body by a new iteration of an SMA knit stocking. The second study compares two versions of the SMA knit garment with a commercially available knit compression garment. The results show that SMA knit compression garments are able to produce medical grade compression on the body, but that sizing and material properties can greatly impact the forces produced. In a comparison of different compression stockings, the user experience of the SMA compression garment was preferred over the alternative garments. Overall, the potential of SMA knit compression is further highlighted, with a clear need for further development to ensure consistent medical grade compression.
身体加压疗法是治疗各种健康问题的重要方法。传统的压力方法，如气动和针织长袜，可提供高质量的压力，但在用户体验方面存在问题（穿脱困难或体积/质量问题）。本文涉及两项与主动压力袜有关的研究，它们利用形状记忆合金（SMA）针织线对人体产生动态压力。当使用家用加热垫加热这些 SMA 针织板时，针织物会收缩并产生动态压力。第一项研究描述了新型 SMA 针织长袜对人体产生的压力。第二项研究将两种版本的 SMA 针织服装与市场上销售的针织压力服装进行了比较。结果表明，SMA 针织压力衣能够对身体产生医疗级的压力，但尺寸和材料特性会对产生的压力产生很大影响。在对不同压力袜的比较中，SMA 压力服的用户体验优于其他服装。总之，SMA 针织压力袜的潜力进一步凸显，但显然需要进一步开发，以确保稳定的医疗级压力。
{"title":"Usability and Performance Comparison of Active Shape Memory and Passive Stockings for Medical Compression","authors":"R. Pettys-Baker, N. Subash, J. Abel, Surbhi Shah, Brad Holschuh","doi":"10.1115/1.4065480","DOIUrl":"https://doi.org/10.1115/1.4065480","url":null,"abstract":"\u0000 On-body compressive therapy is an essential treatment for a variety of health conditions. Traditional compression methods like pneumatics and knit stockings offer quality compression, but present issues with user experience (donning/doffing challenges or bulk/mass issues). This paper covers two studies related to active compression stockings, which utilize knitted shape memory alloy (SMA) wire to produce dynamic compression forces on the body. When these SMA knit panels are heated with an at-home heating pad, the knit contracts and creates dynamic compression. The first study characterizes the forces produced on the body by a new iteration of an SMA knit stocking. The second study compares two versions of the SMA knit garment with a commercially available knit compression garment. The results show that SMA knit compression garments are able to produce medical grade compression on the body, but that sizing and material properties can greatly impact the forces produced. In a comparison of different compression stockings, the user experience of the SMA compression garment was preferred over the alternative garments. Overall, the potential of SMA knit compression is further highlighted, with a clear need for further development to ensure consistent medical grade compression.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"76 s326","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141002340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Functional electrical stimulation (FES) is often used in post-stroke gait rehabilitation to decrease foot drop and increase forward propulsion. However, not all stroke survivors experience clinically meaningful improvements in gait function following training with FES. The purpose of this work was to develop and validate a novel adaptive FES (AFES) system to improve dorsiflexor and plantarflexor stimulation timing and iteratively adjust the stimulation amplitude at each stride based on measured gait biomechanics. Stimulation timing was determined by a series of bilateral footswitches. Stimulation amplitude was calculated based on measured dorsiflexion angle and peak propulsive force, where increased foot drop and decreased paretic propulsion resulted in increased stimulation amplitudes. Ten individuals with chronic post-stroke hemiparesis walked on an adaptive treadmill with adaptive FES for three two-minute trials. Stimulation was delivered at the correct time to the dorsiflexor muscles during 95% of strides, while stimulation was delivered to the plantarflexor muscles at the correct time during 84% of strides. Stimulation amplitudes were correctly calculated and delivered for all except two strides out of nearly 3000. The adaptive FES system responds to real-time gait biomechanics as intended, and further individualization to subject-specific impairments and rehabilitation goals may lead to improved rehabilitation outcomes.
{"title":"Adaptive FES Delivers Stimulation Amplitudes Based on Real-Time Gait Biomechanics","authors":"Margo C. Donlin, Jill Higginson","doi":"10.1115/1.4065479","DOIUrl":"https://doi.org/10.1115/1.4065479","url":null,"abstract":"\u0000 Functional electrical stimulation (FES) is often used in post-stroke gait rehabilitation to decrease foot drop and increase forward propulsion. However, not all stroke survivors experience clinically meaningful improvements in gait function following training with FES. The purpose of this work was to develop and validate a novel adaptive FES (AFES) system to improve dorsiflexor and plantarflexor stimulation timing and iteratively adjust the stimulation amplitude at each stride based on measured gait biomechanics. Stimulation timing was determined by a series of bilateral footswitches. Stimulation amplitude was calculated based on measured dorsiflexion angle and peak propulsive force, where increased foot drop and decreased paretic propulsion resulted in increased stimulation amplitudes. Ten individuals with chronic post-stroke hemiparesis walked on an adaptive treadmill with adaptive FES for three two-minute trials. Stimulation was delivered at the correct time to the dorsiflexor muscles during 95% of strides, while stimulation was delivered to the plantarflexor muscles at the correct time during 84% of strides. Stimulation amplitudes were correctly calculated and delivered for all except two strides out of nearly 3000. The adaptive FES system responds to real-time gait biomechanics as intended, and further individualization to subject-specific impairments and rehabilitation goals may lead to improved rehabilitation outcomes.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"83 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yu Wu, Xingchi Liu, Yuchuan Zhong, Jianchang Zhao, Jinhua Li
Hemorrhage can lead to shock and even death of patients, making one of the main risks in surgical procedures. With the increasing complexity of bleeding during surgical procedures, there is a growing demand for the clip appliers with more functions. However, most traditional clip appliers are rigid, have limited flexibility, and can only fire a single clip within each insertion, which cannot meet the needs of surgeons to efficiently and flexibly control bleeding vessels. In this study, a novel hand-held Hem-o-lok clip applier is proposed, which is designed to have a high flexibility and allow multiple fires of clips. The wrist at the end-effector consists of discrete joints and a flexible shaft, allowing bending in two directions. The tong head at the end-effector enables multiple fires of hemostats, and can be delivered to different positions for clamping blood vessels and human tissues. And it also can be driven to rotate by the flexible shaft. Additionally, an ergonomic handle is designed to control the multi-degree-of-freedom movements of the instrument tip. Finally, the effectiveness of the entire system is evaluated through performance experiments. The design method of this paper can also provide theoretical guidance for other hand-held surgical instruments.
{"title":"Design of a Hand-held Multi-fire Clip Applier with Multiple Dofs for Minimally Invasive Surgery","authors":"Yu Wu, Xingchi Liu, Yuchuan Zhong, Jianchang Zhao, Jinhua Li","doi":"10.1115/1.4065436","DOIUrl":"https://doi.org/10.1115/1.4065436","url":null,"abstract":"\u0000 Hemorrhage can lead to shock and even death of patients, making one of the main risks in surgical procedures. With the increasing complexity of bleeding during surgical procedures, there is a growing demand for the clip appliers with more functions. However, most traditional clip appliers are rigid, have limited flexibility, and can only fire a single clip within each insertion, which cannot meet the needs of surgeons to efficiently and flexibly control bleeding vessels. In this study, a novel hand-held Hem-o-lok clip applier is proposed, which is designed to have a high flexibility and allow multiple fires of clips. The wrist at the end-effector consists of discrete joints and a flexible shaft, allowing bending in two directions. The tong head at the end-effector enables multiple fires of hemostats, and can be delivered to different positions for clamping blood vessels and human tissues. And it also can be driven to rotate by the flexible shaft. Additionally, an ergonomic handle is designed to control the multi-degree-of-freedom movements of the instrument tip. Finally, the effectiveness of the entire system is evaluated through performance experiments. The design method of this paper can also provide theoretical guidance for other hand-held surgical instruments.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"121 S17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141017377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The timely and accurate identification of syringe defects plays a key role in effectively improving product quality in production lines of syringes. In this article, we collected a dataset of image samples representing five common types of syringe defects found on the production line. The dataset comprises over 5000 images, with an average of 3 different syringe defects per image. Based on this dataset, we designed a syringe defect detection model based on an improved YOLOv7-Tiny proposed in this paper. The model combines the Res-PAN structure, the ACmix mixed attention mechanism, the FReLU activation function, and the SIoU loss function. The comparative experiments are conducted on the self-built dataset SYR-Dat to evaluate the performance of the proposed syringe defect detection model. The average precision of the model reaches 94.1%. To ensure the effectiveness of the model, it is compared with other models, including SSD300, Faster R-CNN, EfficientDet, RetinaNet, YOLOv5s, YOLOv6, and YOLOv7. The results demonstrate that the proposed improved YOLOv7-Tiny model can better capture the features of syringe defects. Furthermore, the generalization of the improved YOLOv7-Tiny model is validated on the VOC2012 dataset. The results indicate that the improved model continues to outperform the baseline models. The proposed syringe defect detection model shows promising application prospects, as it can ?weduce the rate of defective products and improve product quality.
{"title":"Enhanced Detection of Syringe Defects Based on an Improved YOLOv7-Tiny Deep-Learning Model","authors":"Wenxuan Zhao, Ling Wang, Chentao Mao, Xiai Chen, Yanfeng Gao, Binrui Wang","doi":"10.1115/1.4065355","DOIUrl":"https://doi.org/10.1115/1.4065355","url":null,"abstract":"\u0000 The timely and accurate identification of syringe defects plays a key role in effectively improving product quality in production lines of syringes. In this article, we collected a dataset of image samples representing five common types of syringe defects found on the production line. The dataset comprises over 5000 images, with an average of 3 different syringe defects per image. Based on this dataset, we designed a syringe defect detection model based on an improved YOLOv7-Tiny proposed in this paper. The model combines the Res-PAN structure, the ACmix mixed attention mechanism, the FReLU activation function, and the SIoU loss function. The comparative experiments are conducted on the self-built dataset SYR-Dat to evaluate the performance of the proposed syringe defect detection model. The average precision of the model reaches 94.1%. To ensure the effectiveness of the model, it is compared with other models, including SSD300, Faster R-CNN, EfficientDet, RetinaNet, YOLOv5s, YOLOv6, and YOLOv7. The results demonstrate that the proposed improved YOLOv7-Tiny model can better capture the features of syringe defects. Furthermore, the generalization of the improved YOLOv7-Tiny model is validated on the VOC2012 dataset. The results indicate that the improved model continues to outperform the baseline models. The proposed syringe defect detection model shows promising application prospects, as it can ?weduce the rate of defective products and improve product quality.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":" 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140686829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This work details the Point Based Value Iteration (PBVI) algorithm for use in multi-sensor systems. Specifically a sensor system capable of heart rate (HR) estimation. An end-to-end embedded Human Activity Recognition (HAR) System was developed to represent the observation uncertainty, and two motion artifact filters (MA) reducing filters are proposed as actions. PBVI allows optimal action decision-making based on an uncertain observation, effectively balancing correct action choice and sensor system cost. Two central systems are proposed to accompany these algorithms, one for unlimited observation access and one for limited observation access. Through simulation, it can be shown that the limited observation system performs optimally when sensor cost is negligible, while limited observation access performs optimally when sensor cost is considered. The final general framework for POMDP and PBVI that was applied to a specific HR estimation example in this work can be expanded on and used as a basis for future work on any similar multi-sensor system.
{"title":"PBVI for Optimal Photoplethysmography Noise Filter Selection Using Human Activity Recognition Observations for Improved Heart Rate Estimation on Multi-Sensor Systems","authors":"Jacob Sindorf, S. Redkar","doi":"10.1115/1.4065219","DOIUrl":"https://doi.org/10.1115/1.4065219","url":null,"abstract":"\u0000 This work details the Point Based Value Iteration (PBVI) algorithm for use in multi-sensor systems. Specifically a sensor system capable of heart rate (HR) estimation. An end-to-end embedded Human Activity Recognition (HAR) System was developed to represent the observation uncertainty, and two motion artifact filters (MA) reducing filters are proposed as actions. PBVI allows optimal action decision-making based on an uncertain observation, effectively balancing correct action choice and sensor system cost. Two central systems are proposed to accompany these algorithms, one for unlimited observation access and one for limited observation access. Through simulation, it can be shown that the limited observation system performs optimally when sensor cost is negligible, while limited observation access performs optimally when sensor cost is considered. The final general framework for POMDP and PBVI that was applied to a specific HR estimation example in this work can be expanded on and used as a basis for future work on any similar multi-sensor system.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"44 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140783717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ashley Carver, Ashley Bjorklund, J. Broomhead, E. Graba, Sadhika Prabhu, Gwen Fischer
Background: ICU patients can require a central venous catheter (CVC) which medical trainees often place. Objective: The purpose of this study was to create a novel 3-dimensional (3D) printed model, based on actual patient anatomy from a deidentified computed tomography (CT) scan, with improved anatomy, tactile properties and realism beyond current task trainers for pediatric CVC simulation. Design/Methods: Bakken researchers converted CT DICOM slices into a 3D model using multiple computer programs and multiple 3D printers. Faculty of various subspecialties at our institution attempted to place a CVC line into the model and then evaluated the model in 5 categories using an anonymous REDCap survey. Results: 15 faculty participated and 14 completed their survey. Feedback, based on a 0-10 scale with 10 being highest, was as follows: the model's size scored an average of 8.4, the model's tactile properties scored a 6.1, the model's anatomy received a 7.1, the model's perceived usefulness for practicing central lines received a 7.6, and the model received a 7.6 in regard to whether it should be utilized in procedural training curriculums. Additional comments were collected in the survey and participants requested the model's blood vessels be fully visible on ultrasound and that the model be firmer. Conclusion(s): Creating a 3D simulation model for pediatric CVC placement is possible. Next steps for this project include revision of the model to be firmer and with improved vessel appearance on ultrasound.
{"title":"Development of an Anatomically Accurate 3D Simulation Model for Pediatric Central Line Placement","authors":"Ashley Carver, Ashley Bjorklund, J. Broomhead, E. Graba, Sadhika Prabhu, Gwen Fischer","doi":"10.1115/1.4065172","DOIUrl":"https://doi.org/10.1115/1.4065172","url":null,"abstract":"\u0000 Background: ICU patients can require a central venous catheter (CVC) which medical trainees often place.\u0000 Objective: The purpose of this study was to create a novel 3-dimensional (3D) printed model, based on actual patient anatomy from a deidentified computed tomography (CT) scan, with improved anatomy, tactile properties and realism beyond current task trainers for pediatric CVC simulation.\u0000 Design/Methods: Bakken researchers converted CT DICOM slices into a 3D model using multiple computer programs and multiple 3D printers. Faculty of various subspecialties at our institution attempted to place a CVC line into the model and then evaluated the model in 5 categories using an anonymous REDCap survey.\u0000 Results: 15 faculty participated and 14 completed their survey. Feedback, based on a 0-10 scale with 10 being highest, was as follows: the model's size scored an average of 8.4, the model's tactile properties scored a 6.1, the model's anatomy received a 7.1, the model's perceived usefulness for practicing central lines received a 7.6, and the model received a 7.6 in regard to whether it should be utilized in procedural training curriculums. Additional comments were collected in the survey and participants requested the model's blood vessels be fully visible on ultrasound and that the model be firmer.\u0000 Conclusion(s): Creating a 3D simulation model for pediatric CVC placement is possible. Next steps for this project include revision of the model to be firmer and with improved vessel appearance on ultrasound.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"104 25","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140379896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shail V Jadav, Karthik Subramanya Karvaje, S. Kadam, V. Vashista, James Sulzer, Ashish Deshpande, H. Palanthandalam-Madapusi
A majority of robotic gait trainers to facilitate physical therapy for gait rehabilitation in humans are based on multi-degree-of-freedom exoskeleton-based systems with sophisticated elctromechanical hardware and software, and consequently remain inaccessible to vast sections of the populations around the world. This study seeks to advance the development of a single degree-of-freedom gait trainer for gait therapy for individuals with neuromuscular impairments. The goal is to offer a cost-effective, accessible solution to cater to the global need for rehabilitation. We build upon the initial gait trainer design presented in Yul Shin, S.(2018) and provide an in-depth analysis and experimental validation of its kinematic performance. Performance of device is also tested and successfully demonstrated through trials involving two healthy individuals to examine its kinematic behaviour under human-induced load conditions. The gait trainer demonstrates satisfactory performance under both no load conditions and a 2kg load, exhibiting an area difference of 1% and 7% respectively. However, when subjected to a 5kg loading condition, a significant area difference of 27% is observed, primarily attributed to the cantilever loading at the driving shaft. A method to adjust link lengths based on specific human gait trajectories is proposed and validated. Additionally, a cost-effective tool for ankle trajectory measurement is introduced for validation. The study demonstrates the potential of an affordable, single DOF gait trainer in facilitating high-volume therapy for those with walking disorders. This research represents a step towards making gait therapy more accessible worldwide.
{"title":"Kinematic Performance of a Customizable Single Degree-of-Freedom Gait Trainer for Cost-Effective Therapy Aimed at Neuromuscular Impairments","authors":"Shail V Jadav, Karthik Subramanya Karvaje, S. Kadam, V. Vashista, James Sulzer, Ashish Deshpande, H. Palanthandalam-Madapusi","doi":"10.1115/1.4065120","DOIUrl":"https://doi.org/10.1115/1.4065120","url":null,"abstract":"\u0000 A majority of robotic gait trainers to facilitate physical therapy for gait rehabilitation in humans are based on multi-degree-of-freedom exoskeleton-based systems with sophisticated elctromechanical hardware and software, and consequently remain inaccessible to vast sections of the populations around the world. This study seeks to advance the development of a single degree-of-freedom gait trainer for gait therapy for individuals with neuromuscular impairments. The goal is to offer a cost-effective, accessible solution to cater to the global need for rehabilitation. We build upon the initial gait trainer design presented in Yul Shin, S.(2018) and provide an in-depth analysis and experimental validation of its kinematic performance. Performance of device is also tested and successfully demonstrated through trials involving two healthy individuals to examine its kinematic behaviour under human-induced load conditions. The gait trainer demonstrates satisfactory performance under both no load conditions and a 2kg load, exhibiting an area difference of 1% and 7% respectively. However, when subjected to a 5kg loading condition, a significant area difference of 27% is observed, primarily attributed to the cantilever loading at the driving shaft. A method to adjust link lengths based on specific human gait trajectories is proposed and validated. Additionally, a cost-effective tool for ankle trajectory measurement is introduced for validation. The study demonstrates the potential of an affordable, single DOF gait trainer in facilitating high-volume therapy for those with walking disorders. This research represents a step towards making gait therapy more accessible worldwide.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"83 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140236631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In view of the lack of commercially available localization grids for MRI-guided interventional procedures, two customizable and easily fabricable grids are proposed. The first one is a patient-specific 3D-printed localization grid that incorporates MRI markers, while the second one is a grid constructed with Superflex Transparent Bolus material. MRI scans were performed with the grids attached on an abdominal phantom. The patient-specific 3D printed grid is visible in T1-weighted, T2-weighted, proton density (PD) and FLAIR MR images, whereas the Superflex grid is visible only in T1-weighted and PD images. However, the Superflex grid offers the advantage of a simpler fabrication process and being more cost-effective. Both proposed localization grids can facilitate the determination of the optimal needle entry positions for MRI-guided interventional procedures, leading to reduced overall procedure time and improved efficiency.
{"title":"Patient-Specific 3D-Printed and Bolus Material-Based Localization Grids for MRI-Guided Interventional Procedures","authors":"Vivien W S Chu, Wing Ki Wong, Louis Lee","doi":"10.1115/1.4065054","DOIUrl":"https://doi.org/10.1115/1.4065054","url":null,"abstract":"\u0000 In view of the lack of commercially available localization grids for MRI-guided interventional procedures, two customizable and easily fabricable grids are proposed. The first one is a patient-specific 3D-printed localization grid that incorporates MRI markers, while the second one is a grid constructed with Superflex Transparent Bolus material. MRI scans were performed with the grids attached on an abdominal phantom. The patient-specific 3D printed grid is visible in T1-weighted, T2-weighted, proton density (PD) and FLAIR MR images, whereas the Superflex grid is visible only in T1-weighted and PD images. However, the Superflex grid offers the advantage of a simpler fabrication process and being more cost-effective. Both proposed localization grids can facilitate the determination of the optimal needle entry positions for MRI-guided interventional procedures, leading to reduced overall procedure time and improved efficiency.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140245860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
During total knee arthroplasty (TKA) surgery, an important step is determining the correct insert thickness for each patient. When the insert is too thick, it leads to stiffness, or when the insert is too thin, it can cause instability. One common method used to determine the insert thickness is manually assessing the joint laxity; this is a qualitative method that depends on the surgeon's experience and 'feel' and is unreliable. The lack of objective methods to reliably determine the correct insert thickness creates a need to develop such a method. One possible method is to measure the force required to push a trial insert into position, requiring a specialized tool to measure the push force. Hence, a new measuring tool was designed to measure the push force intraoperatively, accurately, and safely. To demonstrate functionality, the tool was tested on three patients. During the tests, the surgeon determined the appropriate thicknesses of the insert to trial and proceeded to position three different insert thicknesses ranging from 10 mm to 12 mm, and example forces were recorded. The new tool met all the design criteria, and the example results from the patient testing show promise in using the peak force to identify the insert with the correct thickness.
{"title":"A New Handheld Tool To Select The Correct Tibial Insert Thickness By Measuring The Force To Push A Trial Insert Into Position During Total Knee Arthroplasty Surgery","authors":"Gabriel Santana, Stephen M Howell, Maury L. Hull","doi":"10.1115/1.4064973","DOIUrl":"https://doi.org/10.1115/1.4064973","url":null,"abstract":"\u0000 During total knee arthroplasty (TKA) surgery, an important step is determining the correct insert thickness for each patient. When the insert is too thick, it leads to stiffness, or when the insert is too thin, it can cause instability. One common method used to determine the insert thickness is manually assessing the joint laxity; this is a qualitative method that depends on the surgeon's experience and 'feel' and is unreliable. The lack of objective methods to reliably determine the correct insert thickness creates a need to develop such a method. One possible method is to measure the force required to push a trial insert into position, requiring a specialized tool to measure the push force. Hence, a new measuring tool was designed to measure the push force intraoperatively, accurately, and safely. To demonstrate functionality, the tool was tested on three patients. During the tests, the surgeon determined the appropriate thicknesses of the insert to trial and proceeded to position three different insert thicknesses ranging from 10 mm to 12 mm, and example forces were recorded. The new tool met all the design criteria, and the example results from the patient testing show promise in using the peak force to identify the insert with the correct thickness.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"12 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140412235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel J Orr, Christian Payne, Hailey E Jones, JAmes Anderson, Alek Sperry, Brandon Sargent, Bruce Frankel, Larry L Howell, Anton E. Bowden
As spinal fusion surgery continues to transition to less invasive techniques, there remains an unmet need for ever smaller and more complex interbody cages to meet the unique needs of this difficult surgery. This work focuses on the hypothesis that this need can be met using the inherent advantages of compliant mechanisms in a way no previous device has. Deployable Euler Spiral Connectors optimized using a gradient based optimization algorithm were used as the foundation for a device that can stow to a very small size for device insertion then bilaterally deploy to a substantially larger device footprint. Additionally, a continuously adjustable lordotic angle was achieved using the same device so as to result in a customized anatomical fit while potentially reducing hospital inventory requirements. Several tests including finite element analysis, compression testing, shear testing, and deployment in a cadaver were performed as initial verification and validation that the concept device performs reasonably well under typical testing paradigms used for interbody cages.
{"title":"Leveraging Compliance to Design a Minimally Invasive, Expandable Interbody Cage Capable of Customized Anatomical Fit for Spinal Fusion Surgery","authors":"Daniel J Orr, Christian Payne, Hailey E Jones, JAmes Anderson, Alek Sperry, Brandon Sargent, Bruce Frankel, Larry L Howell, Anton E. Bowden","doi":"10.1115/1.4064963","DOIUrl":"https://doi.org/10.1115/1.4064963","url":null,"abstract":"\u0000 As spinal fusion surgery continues to transition to less invasive techniques, there remains an unmet need for ever smaller and more complex interbody cages to meet the unique needs of this difficult surgery. This work focuses on the hypothesis that this need can be met using the inherent advantages of compliant mechanisms in a way no previous device has. Deployable Euler Spiral Connectors optimized using a gradient based optimization algorithm were used as the foundation for a device that can stow to a very small size for device insertion then bilaterally deploy to a substantially larger device footprint. Additionally, a continuously adjustable lordotic angle was achieved using the same device so as to result in a customized anatomical fit while potentially reducing hospital inventory requirements. Several tests including finite element analysis, compression testing, shear testing, and deployment in a cadaver were performed as initial verification and validation that the concept device performs reasonably well under typical testing paradigms used for interbody cages.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140414958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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