The most challenging procedure for lumbar puncture (LP) is accurately puncturing the spinal membrane (dura mater) based on an automatic needle insertion device (NID). Piezoactuated NID has shown its advantages in robotic-assisted LP with high precision and compact structure. Soft control of the NID is important for insertion safety; however, for stick-slip piezo-actuated NID, there are few studies due to the complex mechanism of stick-slip motion. Here, a modeling and admittance control method for a proposed stick-slip piezoactuated NID is proposed for safe puncture of the spinal membrane. To analytically model the NID, the compliant mechanism (CM) in the NID is reduced to a second-order system. The stick-slip friction and the spinal membrane are modeled based on the LuGre model and the Hunt-Crossley model, respectively. Based on these models, an admittance controller (AC) for the proposed NID is established to realize the precise control of the position and the safety protection against puncture errors. Simulations and preliminary experiments based on a prototype of the NID and a phantom of the spinal membrane were carried out to test the proposed modeling and control method. Results show that the proposed NID with AC has a maximum insertion error of 0.62 mm and the insertion depth decays by 80% when an unexpected force is applied. Therefore, the proposed model and control method have the potential to be used in real LP procedures by further development.
腰椎穿刺术（LP）最具挑战性的操作是在自动进针装置（NID）的基础上准确穿刺脊膜（硬脑膜）。压电式 NID 具有精度高、结构紧凑等优点，已在机器人辅助的腰椎穿刺中显示出其优势。NID 的软控制对插入安全性非常重要；然而，由于粘滑运动机制复杂，针对粘滑压电 NID 的研究很少。本文提出了一种用于脊膜安全穿刺的粘性滑动压电 NID 的建模和导纳控制方法。为了对 NID 进行分析建模，NID 中的顺应机构 (CM) 被简化为一个二阶系统。粘滑摩擦和脊膜分别根据 LuGre 模型和 Hunt-Crossley 模型建模。在这些模型的基础上，为拟议的 NID 建立了一个导纳控制器（AC），以实现对位置的精确控制和对穿刺误差的安全保护。为了测试所提出的建模和控制方法，我们基于 NID 原型和脊膜模型进行了模拟和初步实验。结果表明，所提出的带交流电的 NID 的最大插入误差为 0.62 毫米，当施加意外力时，插入深度下降 80%。因此，通过进一步开发，所提出的模型和控制方法有可能用于实际的 LP 程序。
{"title":"Modeling and Admittance Control of a Piezoactuated Needle Insertion Device for Safe Puncture of Spinal Membranes","authors":"Yuzhou Duan, Jie Ling, Yuchuan Zhu","doi":"10.1115/1.4066045","DOIUrl":"https://doi.org/10.1115/1.4066045","url":null,"abstract":"\u0000 The most challenging procedure for lumbar puncture (LP) is accurately puncturing the spinal membrane (dura mater) based on an automatic needle insertion device (NID). Piezoactuated NID has shown its advantages in robotic-assisted LP with high precision and compact structure. Soft control of the NID is important for insertion safety; however, for stick-slip piezo-actuated NID, there are few studies due to the complex mechanism of stick-slip motion. Here, a modeling and admittance control method for a proposed stick-slip piezoactuated NID is proposed for safe puncture of the spinal membrane. To analytically model the NID, the compliant mechanism (CM) in the NID is reduced to a second-order system. The stick-slip friction and the spinal membrane are modeled based on the LuGre model and the Hunt-Crossley model, respectively. Based on these models, an admittance controller (AC) for the proposed NID is established to realize the precise control of the position and the safety protection against puncture errors. Simulations and preliminary experiments based on a prototype of the NID and a phantom of the spinal membrane were carried out to test the proposed modeling and control method. Results show that the proposed NID with AC has a maximum insertion error of 0.62 mm and the insertion depth decays by 80% when an unexpected force is applied. Therefore, the proposed model and control method have the potential to be used in real LP procedures by further development.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"37 18","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141816777","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}
A. Mallick, Bijit Basumatary, Mukesh Kumar, Kamaldeep Arora, Durba Pal, A. Sahani
Objective: Pressure ulcer (PU) is a serious issue among newborns, particularly those who are premature and have medical conditions that require hospitalization. Existing conventional beds require the modifications that can reduce the chance of PU and extra effort of nursing staff. Methods: In this work, a force-sensing resistor array (FSRA) mattress is implemented that detects high-pressure points. The microcontroller processes the data that are collected from the FSRA using an electronic circuit based on the principle of voltage divider circuits. The multiplexer identifies the pixels of high-pressure points and plots the heat maps using MATLAB. Results: The results of the FSRA mattress use an alternately inflating and deflating pressure channel bed act as an anti-PU bed and compares it with the currently deployed bed. The demonstrated work was validated using the Finite Element Modeling framework. Conclusion: This anti-PU bed is effective in detecting high-pressure points; based on that, chances of PUs in neonates can be prevented. The performance evaluation of the designed and tested anti-PU bed with more accuracy and automatically varies the contact position to reduce the efforts made by the nursing staff. Clinical impact: This innovation significantly improves the quality of life as compared to the conventional methods to avoid PUs for NICUs.
目的：压疮（PU）是新生儿中的一个严重问题，尤其是那些早产儿和患有需要住院治疗的疾病的新生儿。需要对现有的传统病床进行改造，以减少压疮发生的几率和护理人员的额外工作量。方法：在这项工作中，采用了一种力感应电阻阵列（FSRA）床垫来检测高压点。微控制器利用基于分压电路原理的电子电路处理从 FSRA 收集到的数据。多路复用器可识别高压点像素，并使用 MATLAB 绘制热图。结果：FSRA 床垫使用交替充气和放气的压力通道床作为防 PU 床，并将其与当前部署的床进行比较。使用有限元建模框架对演示工作进行了验证。结论：这种防 PU 床能有效检测高压点，从而防止新生儿发生 PU。对设计和测试的防 PU 床进行了性能评估，结果表明其准确性更高，并能自动改变接触位置，从而减少护理人员的工作量。临床影响：与避免新生儿重症监护病房发生 PU 的传统方法相比，这项创新大大提高了新生儿的生活质量。
{"title":"Performance Evaluation of Neonatal Anti-Pressure Ulcer Bed Using a Novel Force Sensing Array","authors":"A. Mallick, Bijit Basumatary, Mukesh Kumar, Kamaldeep Arora, Durba Pal, A. Sahani","doi":"10.1115/1.4065892","DOIUrl":"https://doi.org/10.1115/1.4065892","url":null,"abstract":"\u0000 Objective: Pressure ulcer (PU) is a serious issue among newborns, particularly those who are premature and have medical conditions that require hospitalization. Existing conventional beds require the modifications that can reduce the chance of PU and extra effort of nursing staff. Methods: In this work, a force-sensing resistor array (FSRA) mattress is implemented that detects high-pressure points. The microcontroller processes the data that are collected from the FSRA using an electronic circuit based on the principle of voltage divider circuits. The multiplexer identifies the pixels of high-pressure points and plots the heat maps using MATLAB. Results: The results of the FSRA mattress use an alternately inflating and deflating pressure channel bed act as an anti-PU bed and compares it with the currently deployed bed. The demonstrated work was validated using the Finite Element Modeling framework. Conclusion: This anti-PU bed is effective in detecting high-pressure points; based on that, chances of PUs in neonates can be prevented. The performance evaluation of the designed and tested anti-PU bed with more accuracy and automatically varies the contact position to reduce the efforts made by the nursing staff. Clinical impact: This innovation significantly improves the quality of life as compared to the conventional methods to avoid PUs for NICUs.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":" 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141677547","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 Berger, Jan T. Sehrt, Thomas Brinkmann, Niclas Norman Henrichs, Oguzhan Bilec, Karl-Hermann Fuchs, Alexander Meining
Development of medical products begins with the “in silico” phase, where the development and simulation of new stent types is carried out. This is followed by the “in vitro” phase. Here, tests are done in a test stand to obtain initial conclusions about the interaction of the environment. The approval process is completed in the “in vivo” phase, where testing in living beings happen. Here, preclinical studies are carried out in animals first, followed by clinical studies on patients. A big part of the development fails in this final phase, as this is where the interactions of all influences from the stent environment are investigated. Since this not only causes high costs for the developers, but also unnecessarily destroys living resources in animal studies, this publication describes the development of a test stand called "SwallowSim" that superimposes the mechanical influences of the esophagus, the chemical stress caused by hydrochloric acid and increased body temperature. Furthermore, tests of the acting pressures are carried out using esophageal manometry, a temperature test of the test stand and a test run of the gastric juice. At the end of this publication, the results are evaluated with a six-week test of a Nickel Titanium Naval Ordnance Laboratory stent, which loses much of its mechanical properties and is partially destroyed by the load. The results show a clear correlation with the findings from reality. The test stand should be further optimised and examined in more detail in further tests and subjected to a reality check.
{"title":"The Development of a Novel Peristaltic Test Stand “Swallow-Sim” for the Mechanical Evaluation of Esophageal Stents","authors":"Daniel Berger, Jan T. Sehrt, Thomas Brinkmann, Niclas Norman Henrichs, Oguzhan Bilec, Karl-Hermann Fuchs, Alexander Meining","doi":"10.1115/1.4065906","DOIUrl":"https://doi.org/10.1115/1.4065906","url":null,"abstract":"\u0000 Development of medical products begins with the “in silico” phase, where the development and simulation of new stent types is carried out. This is followed by the “in vitro” phase. Here, tests are done in a test stand to obtain initial conclusions about the interaction of the environment. The approval process is completed in the “in vivo” phase, where testing in living beings happen. Here, preclinical studies are carried out in animals first, followed by clinical studies on patients. A big part of the development fails in this final phase, as this is where the interactions of all influences from the stent environment are investigated. Since this not only causes high costs for the developers, but also unnecessarily destroys living resources in animal studies, this publication describes the development of a test stand called \"SwallowSim\" that superimposes the mechanical influences of the esophagus, the chemical stress caused by hydrochloric acid and increased body temperature. Furthermore, tests of the acting pressures are carried out using esophageal manometry, a temperature test of the test stand and a test run of the gastric juice. At the end of this publication, the results are evaluated with a six-week test of a Nickel Titanium Naval Ordnance Laboratory stent, which loses much of its mechanical properties and is partially destroyed by the load. The results show a clear correlation with the findings from reality. The test stand should be further optimised and examined in more detail in further tests and subjected to a reality check.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"72 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141691369","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 natural orifice transluminal endoscopic surgery, the flexible endoscopic surgical robot utilizes a continuum configuration to navigate narrow, multi-curvature esophageal pathways. However, the tool channel's dimensional limitations and the restricted internal layout make it challenging to reduce the outside diameter and highly efficient variable stiffness function significantly. As a result, safe insertion into the esophagus and precise operation remains hugely challenging. In this paper, an esophageal sleeve with variable stiffness and internal diameter is developed for endoscopic procedures. The proposed esophageal sleeve adopts specially designed spiral elastic deployable parts that allow for variations in internal diameter. Furthermore, the elastic deployable parts are designed with serrated protrusion structures that can realize rapid transition between rigidity and flexibility under negative pressure. Fundamental experimental results showed that the outer diameter of the proposed esophageal sleeve can expand from 17 mm to 20 mm, providing inner access up to 13 mm for endoscopic instruments. The serrated protrusion structure allows the esophageal sleeve to rapidly transition from a flexible to a rigid state, resulting in a stiffness gain of approximately 5. Phantom experiments validated the effectiveness and usability of the proposed Esophageal sleeve in assisting endoscope insertion, demonstrating its potential clinical value in endoscopic procedures.
{"title":"Development of an Esophageal Sleeve with Variable Stiffness and Internal Diameter for Endoscopic Surgery","authors":"Haibo Wang, Xinwei Liu, Zongyu Chang","doi":"10.1115/1.4065836","DOIUrl":"https://doi.org/10.1115/1.4065836","url":null,"abstract":"\u0000 In natural orifice transluminal endoscopic surgery, the flexible endoscopic surgical robot utilizes a continuum configuration to navigate narrow, multi-curvature esophageal pathways. However, the tool channel's dimensional limitations and the restricted internal layout make it challenging to reduce the outside diameter and highly efficient variable stiffness function significantly. As a result, safe insertion into the esophagus and precise operation remains hugely challenging. In this paper, an esophageal sleeve with variable stiffness and internal diameter is developed for endoscopic procedures. The proposed esophageal sleeve adopts specially designed spiral elastic deployable parts that allow for variations in internal diameter. Furthermore, the elastic deployable parts are designed with serrated protrusion structures that can realize rapid transition between rigidity and flexibility under negative pressure. Fundamental experimental results showed that the outer diameter of the proposed esophageal sleeve can expand from 17 mm to 20 mm, providing inner access up to 13 mm for endoscopic instruments. The serrated protrusion structure allows the esophageal sleeve to rapidly transition from a flexible to a rigid state, resulting in a stiffness gain of approximately 5. Phantom experiments validated the effectiveness and usability of the proposed Esophageal sleeve in assisting endoscope insertion, demonstrating its potential clinical value in endoscopic procedures.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"55 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141716165","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}
Emmanuel Yangue, Ashish Ranjan, Yu Feng, Chenang Liu
Medical imaging is a crucial tool in clinics to monitor tumor treatment progress. In practice, many imaging tools (such as MRI and CT scans) are in general costly and may also expose patients to radiation, leading to potential side effects. Recent studies have demonstrated that ultrasound imaging, which is safe, low-cost, and easy to access, can monitor the drug delivery progress in solid tumors. However, the noisy nature of ultrasound images and the high-level uncertainty of cancer disease progression are still challenging in ultrasound-based tumor treatment monitoring. To overcome these barriers, this work presents a comparative study to explore the potential advantages of the emerging diffusion generative models against the commonly applied state-of-the-art generative models. Namely, the denoising diffusion models (DDMs), against the generative adversarial networks (GAN), and variational autoencoders (VAE), are used for analyzing the ultrasound images through image augmentation. These models are evaluated based on their capacity to augment ultrasound images for exploring the potential variations of tumor treatment monitoring. The results across different cases indicate that the DDIM/KID-IS model leveraged in this work outperforms the other models in the study in terms of similarity, diversity, and predictive accuracy. Therefore, further investigation of such diffusion generative models could be considered as they can potentially serve as a great predictive tool for ultrasound image-enabled tumor treatment monitoring in the future.
{"title":"Toward Smart Ultrasound Image Augmentation to Advance Tumor Treatment Monitoring: Exploring the Potential of Diffusion Generative Model","authors":"Emmanuel Yangue, Ashish Ranjan, Yu Feng, Chenang Liu","doi":"10.1115/1.4065905","DOIUrl":"https://doi.org/10.1115/1.4065905","url":null,"abstract":"\u0000 Medical imaging is a crucial tool in clinics to monitor tumor treatment progress. In practice, many imaging tools (such as MRI and CT scans) are in general costly and may also expose patients to radiation, leading to potential side effects. Recent studies have demonstrated that ultrasound imaging, which is safe, low-cost, and easy to access, can monitor the drug delivery progress in solid tumors. However, the noisy nature of ultrasound images and the high-level uncertainty of cancer disease progression are still challenging in ultrasound-based tumor treatment monitoring. To overcome these barriers, this work presents a comparative study to explore the potential advantages of the emerging diffusion generative models against the commonly applied state-of-the-art generative models. Namely, the denoising diffusion models (DDMs), against the generative adversarial networks (GAN), and variational autoencoders (VAE), are used for analyzing the ultrasound images through image augmentation. These models are evaluated based on their capacity to augment ultrasound images for exploring the potential variations of tumor treatment monitoring. The results across different cases indicate that the DDIM/KID-IS model leveraged in this work outperforms the other models in the study in terms of similarity, diversity, and predictive accuracy. Therefore, further investigation of such diffusion generative models could be considered as they can potentially serve as a great predictive tool for ultrasound image-enabled tumor treatment monitoring in the future.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"34 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141688877","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}
Robotic Laparoendoscopic Single Site Surgery (LESS) is emerging as a hot research topic with the advancement of robotics. However, the movement of the rigid catheter inserted through a fixed incision into the patient's body cavity is constrained to a conical workspace, and the surgical instruments introduced through channels in the catheter can hardly perform necessary operations when the target tissue is close to the boundary of this workspace. In this paper, we present a novel robotic system for LESS with a bendable catheter that allows the catheter centerline to be oriented towards the target tissue over a larger area, thus providing a better initial position for the surgical instruments and enlarging the workspace of the instruments. The diameter of the bendable catheter is 30 mm and the length is 22 mm. The bendable portion of the catheter provides 2 degrees of freedom (DOF) within the body cavity and can be bent up to 45°. The system consists of two continuum instruments with 6 DOF and a 3D endoscope with 5 DOF. System design, kinematic analysis and teleoperation algorithm are introduced in detail. Preliminary experiments are performed to verify the feasibility and effectiveness of the proposed system. The results prove the applicability of the system in LESS.
随着机器人技术的发展，机器人腹腔镜单部位手术（LESS）正成为一个热门研究课题。然而，通过固定切口插入患者体腔的刚性导管的运动受限于一个锥形工作空间，当目标组织接近该工作空间的边界时，通过导管中的通道引入的手术器械很难进行必要的操作。在本文中，我们介绍了一种新型 LESS 机器人系统，该系统采用可弯曲导管，导管中心线可在更大范围内朝向靶组织，从而为手术器械提供更好的初始位置，并扩大器械的工作空间。可弯曲导管的直径为 30 毫米，长度为 22 毫米。导管的可弯曲部分在体腔内提供 2 个自由度 (DOF)，最大可弯曲 45°。该系统由两个具有 6 个自由度的连续器械和一个具有 5 个自由度的 3D 内窥镜组成。详细介绍了系统设计、运动学分析和远程操作算法。为验证所提系统的可行性和有效性，进行了初步实验。结果证明了该系统在 LESS 中的适用性。
{"title":"A Robotic System with a Bendable Catheter for Laparoendoscopic Single Site Surgery","authors":"Zhenxuan Hu, Jinhua Li, Xingchi Liu, Shuxin Wang","doi":"10.1115/1.4065730","DOIUrl":"https://doi.org/10.1115/1.4065730","url":null,"abstract":"\u0000 Robotic Laparoendoscopic Single Site Surgery (LESS) is emerging as a hot research topic with the advancement of robotics. However, the movement of the rigid catheter inserted through a fixed incision into the patient's body cavity is constrained to a conical workspace, and the surgical instruments introduced through channels in the catheter can hardly perform necessary operations when the target tissue is close to the boundary of this workspace. In this paper, we present a novel robotic system for LESS with a bendable catheter that allows the catheter centerline to be oriented towards the target tissue over a larger area, thus providing a better initial position for the surgical instruments and enlarging the workspace of the instruments. The diameter of the bendable catheter is 30 mm and the length is 22 mm. The bendable portion of the catheter provides 2 degrees of freedom (DOF) within the body cavity and can be bent up to 45°. The system consists of two continuum instruments with 6 DOF and a 3D endoscope with 5 DOF. System design, kinematic analysis and teleoperation algorithm are introduced in detail. Preliminary experiments are performed to verify the feasibility and effectiveness of the proposed system. The results prove the applicability of the system in LESS.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"12 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141340752","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}
yan zhang, Haipo Cui, Kewei Du, Xudong Guo, Ruonan Fu, Qi Zhang
Identifying the optimal position for Kirschner wire (K-wire) is crucial in tension band wiring for patellar fracture. This study analyzed the ideal position and designed a guide device to aid precise K-wire insertion. The stress and displacement at 90° of flexion were compared to determine the optimal positions. The number of insertions and fluoroscopies, and operating times were recorded in a retrospective study. Intraoperative radiographs were used to measure the K-wire position relative to the patella in the coronal and sagittal planes to assess accuracy. The least stability occurred when the distance between the K-wires was 1/2 of the patellar width in the coronal plane and close to the patellar anterior surface. The number of K-wire insertions in the experimental group and control group (1.33 ±0.58 vs 3.8 ±1.03; P = 0.009), the number of fluoroscopies (2.67 ±0.58 vs 10 ±1.33; P = 0.007), and the operating time (55 ±8.66 min vs 82 ±9.49 min; P = 0.001) were significantly different. K-wires should parallel to each other, spaced 1/4 or 1/3 of the patellar width in the coronal plane, and 1/2 to 3/4 of the patellar thickness in the sagittal plane away from the patellar anterior surface. The surgeon could improve insertion accuracy with guide device.
确定 Kirschner 线（K 线）的最佳位置对于髌骨骨折的张力带布线至关重要。本研究分析了理想位置，并设计了一种引导装置，以帮助精确插入 K 线。通过比较屈曲 90° 时的应力和位移来确定最佳位置。回顾性研究记录了插入和透视次数以及手术时间。术中X光片用于测量K线在冠状面和矢状面相对于髌骨的位置，以评估准确性。在冠状面上，当K线之间的距离为髌骨宽度的1/2且靠近髌骨前表面时，稳定性最低。实验组和对照组的 K 线插入次数（1.33 ±0.58 vs 3.8 ±1.03；P = 0.009）、透视次数（2.67 ±0.58 vs 10 ±1.33；P = 0.007）和手术时间（55 ±8.66 min vs 82 ±9.49 min；P = 0.001）有显著差异。K线应相互平行，在冠状面上间距为髌骨宽度的1/4或1/3，在矢状面上间距为髌骨厚度的1/2至3/4，远离髌骨前表面。外科医生可通过导引装置提高插入的准确性。
{"title":"Design and Evaluation of Kirschner Wire Guide Device for Patellar Fracture Fixation","authors":"yan zhang, Haipo Cui, Kewei Du, Xudong Guo, Ruonan Fu, Qi Zhang","doi":"10.1115/1.4065578","DOIUrl":"https://doi.org/10.1115/1.4065578","url":null,"abstract":"\u0000 Identifying the optimal position for Kirschner wire (K-wire) is crucial in tension band wiring for patellar fracture. This study analyzed the ideal position and designed a guide device to aid precise K-wire insertion. The stress and displacement at 90° of flexion were compared to determine the optimal positions. The number of insertions and fluoroscopies, and operating times were recorded in a retrospective study. Intraoperative radiographs were used to measure the K-wire position relative to the patella in the coronal and sagittal planes to assess accuracy. The least stability occurred when the distance between the K-wires was 1/2 of the patellar width in the coronal plane and close to the patellar anterior surface. The number of K-wire insertions in the experimental group and control group (1.33 ±0.58 vs 3.8 ±1.03; P = 0.009), the number of fluoroscopies (2.67 ±0.58 vs 10 ±1.33; P = 0.007), and the operating time (55 ±8.66 min vs 82 ±9.49 min; P = 0.001) were significantly different. K-wires should parallel to each other, spaced 1/4 or 1/3 of the patellar width in the coronal plane, and 1/2 to 3/4 of the patellar thickness in the sagittal plane away from the patellar anterior surface. The surgeon could improve insertion accuracy with guide device.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141114130","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}
John Mould, Alex Kelly, Ashley Peterson, Nuno Rebelo
We describe a phenomenological constitutive model for representing Nitinol in medical device applications. The intent is to capture some of the response features important to medical device applications that are neglected in prevalent state of the art models. These features include better representation of the response under compression which is needed to assess bending, and asymmetric plastic yield. We will refer to this implementation as the Thornton Tomasetti (TT) model to distinguish it from other existing implementations that have evolved from the baseline underlying theory. We implement the model in a modular form suitable for use in commercial finite element software and describe initialization from laboratory test data.
{"title":"A Modular Nitinol Model with Lode Angle-Based Asymmetry and Improved Representation of the Superelastic Loops for Medical Device Applications","authors":"John Mould, Alex Kelly, Ashley Peterson, Nuno Rebelo","doi":"10.1115/1.4065513","DOIUrl":"https://doi.org/10.1115/1.4065513","url":null,"abstract":"\u0000 We describe a phenomenological constitutive model for representing Nitinol in medical device applications. The intent is to capture some of the response features important to medical device applications that are neglected in prevalent state of the art models. These features include better representation of the response under compression which is needed to assess bending, and asymmetric plastic yield. We will refer to this implementation as the Thornton Tomasetti (TT) model to distinguish it from other existing implementations that have evolved from the baseline underlying theory. We implement the model in a modular form suitable for use in commercial finite element software and describe initialization from laboratory test data.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"40 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140970468","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}
Robert Knutson, Justin Whitten, David Graham, Craig Shankwitz, Corey Pew
Trips and falls are a major concern for older adults. The resulting injury and loss of mobility can have a significant impact on quality of life. An emerging field of study, known as Perturbation Training, has been shown to reduce injury rates associated with trips and falls in older adults. Treadmills traditionally used for Perturbation Training are large, expensive, and immobile, forcing users to travel long distances to receive care. A portable treadmill would serve a larger portion of the at-risk population than current methods. We developed a portable, low-cost, twin-belt perturbation treadmill capable of high-intensity Perturbation Training. Belt speeds are controlled by a custom mechanical and software interface, allowing operators with no programming experience to control the device. The treadmill can accommodate users up to 118 kg and provides a maximum acceleration and speed of 12 m/s2 and 3.3 m/s, respectively, under full load. The total weight is 180 kg, and the treadmill can be moved like a wheelbarrow, with handles in the back and wheels in the front. The prototype was validated with mechanical and human participant testing, showing it as a viable device for Perturbation Training. In this paper, we will go over the design, fabrication, and validation processes used to create the Portable Perturbation Treadmill.
{"title":"Design, Fabrication, and Validation of a Portable Perturbation Treadmill for Balance Recovery Research","authors":"Robert Knutson, Justin Whitten, David Graham, Craig Shankwitz, Corey Pew","doi":"10.1115/1.4065514","DOIUrl":"https://doi.org/10.1115/1.4065514","url":null,"abstract":"\u0000 Trips and falls are a major concern for older adults. The resulting injury and loss of mobility can have a significant impact on quality of life. An emerging field of study, known as Perturbation Training, has been shown to reduce injury rates associated with trips and falls in older adults. Treadmills traditionally used for Perturbation Training are large, expensive, and immobile, forcing users to travel long distances to receive care. A portable treadmill would serve a larger portion of the at-risk population than current methods. We developed a portable, low-cost, twin-belt perturbation treadmill capable of high-intensity Perturbation Training. Belt speeds are controlled by a custom mechanical and software interface, allowing operators with no programming experience to control the device. The treadmill can accommodate users up to 118 kg and provides a maximum acceleration and speed of 12 m/s2 and 3.3 m/s, respectively, under full load. The total weight is 180 kg, and the treadmill can be moved like a wheelbarrow, with handles in the back and wheels in the front. The prototype was validated with mechanical and human participant testing, showing it as a viable device for Perturbation Training. In this paper, we will go over the design, fabrication, and validation processes used to create the Portable Perturbation Treadmill.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"56 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140971001","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}
Qiye Wen, Chang Cai, Jiayi Fang, Zifeng Luo, Yuanwei Luo, Chong Wang, Weixiong Liang, Song Wang
Thyroid surgeons have increasingly emphasized functional protection in thyroid surgery, including the hot and difficult issue of intraoperative identification and functional protection of parathyroid glands. Intraoperative parathyroid imaging methods can identify parathyroid glands to some extent, but they have limitations in cases where contrast agents are used preoperatively or frozen sections are used postoperatively.This paper presents the design and validation of a miniaturized and integrated all-in-one parathyroid-specific lumenscope. The device integrates Raman spectroscopy and laser scattering technology and utilizes algorithms to locate the parathyroid glands. Its purpose is to provide real-time protection of the parathyroid glands without the need for dye-based tissue identification. The device comprises two distinct parts: the mechanics of the cavity lens used for surgical operations and the design of the software system that fuses the image signals. It has been validated in ex vivo tissue experiments and preliminary clinical trials to enable miniaturization and integration of visual fluorescence localization techniques. The device aims to achieve objective, safe, accurate, and convenient parathyroid function protection.
{"title":"A miniaturized endoscopic device integrating Raman spectroscopy and laser speckle technology via an image fusion algorithm for intraoperative identification and functional protection of parathyroid glands","authors":"Qiye Wen, Chang Cai, Jiayi Fang, Zifeng Luo, Yuanwei Luo, Chong Wang, Weixiong Liang, Song Wang","doi":"10.1115/1.4065481","DOIUrl":"https://doi.org/10.1115/1.4065481","url":null,"abstract":"\u0000 Thyroid surgeons have increasingly emphasized functional protection in thyroid surgery, including the hot and difficult issue of intraoperative identification and functional protection of parathyroid glands. Intraoperative parathyroid imaging methods can identify parathyroid glands to some extent, but they have limitations in cases where contrast agents are used preoperatively or frozen sections are used postoperatively.This paper presents the design and validation of a miniaturized and integrated all-in-one parathyroid-specific lumenscope. The device integrates Raman spectroscopy and laser scattering technology and utilizes algorithms to locate the parathyroid glands. Its purpose is to provide real-time protection of the parathyroid glands without the need for dye-based tissue identification. The device comprises two distinct parts: the mechanics of the cavity lens used for surgical operations and the design of the software system that fuses the image signals. It has been validated in ex vivo tissue experiments and preliminary clinical trials to enable miniaturization and integration of visual fluorescence localization techniques. The device aims to achieve objective, safe, accurate, and convenient parathyroid function protection.","PeriodicalId":506673,"journal":{"name":"Journal of Medical Devices","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141005126","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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