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Evaluating Gender Differences in Treatment of Simulated Gunshot Wounds Using a Female Retrofit 评估女性改装在模拟枪伤治疗中的性别差异
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1018
Curtis M. Craig, Bradley A Drahos, Katelyn R. Schwieters, Nichole L. Morris, Mandi Lye, Timothy M. Kowalewski, Jack Norfleet, Mark V. Mazzeo
Female soldiers are at greater risk of injury and have higher death rates compared to male soldiers. Female casualties are underrepresented in existing training materials for battlefield medics and the patient simulators are often masculine in appearance. The current study assesses the suitability of a female retrofit for male patient simulators and explores the existence of disparities in treatment between male and female patient simulators among combat medic trainees. Thirty-six participants undergoing training at a U.S. Army Medical Simulation Training Center performed a series of basic procedures on both a male patient simulator and a similar patient simulator with a female retrofit. The chest seal procedure was video-recorded and coded for errors committed by the trainees and analyzed to determine whether the apparent gender and order of the patient simulators affected error likelihood and rate. The results indicated that gender and order did not affect the likelihood of optimal performance, but if trainees treated the female retrofitted patient simulator first, they tended to commit more errors. Therefore, the use of a female retrofit may be useful for providing parity in training for gender; however, the issue of gender disparities remains a pressing issue for medical device design and research.
与男兵相比,女兵受伤的风险更大,死亡率也更高。在现有的战地医务人员培训材料中,女性伤亡人数不足,而病人模拟器的外观往往是男性化的。本研究评估了男性患者模拟器的女性改装的适用性,并探讨了在战斗医学学员中男性和女性患者模拟器之间存在的治疗差异。在美国陆军医学模拟训练中心接受训练的36名参与者在男性患者模拟器和女性改装的类似患者模拟器上执行了一系列基本程序。对胸封过程进行录像并对受训者所犯的错误进行编码,并对其进行分析,以确定患者模拟器的表面性别和顺序是否会影响错误的可能性和发生率。结果表明,性别和顺序不影响最佳表现的可能性,但如果受训者首先治疗女性改装的病人模拟器,他们往往会犯更多的错误。因此,利用女性改造可能有助于在性别培训方面提供平等;然而,性别差异问题仍然是医疗器械设计和研究的一个紧迫问题。
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引用次数: 2
Additive Manufacturing of Medical Microdevices 医用微型设备的增材制造
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1042
Renc Saracaydin, S. Hara
Additive manufacturing is a growing field, but its application in the fabrication of medical microdevices has not been fully explored. Traditionally, medical microdevices are manufactured via a combination of techniques such as photolithography, laser-cutting, and micromolding, which collectively have challenges such as multiple fabrication steps, limited design freedom, high fabrication cost, and significant fabrication time. Micro vat photopolymerization is presented here as an alternative method to produce four different microscale medical devices that have applications in microfluidics, drug delivery, and bioscaffolding. In terms of minimum feature size and resolution, the presented structures are comparable, if not superior, to literature quoted parts fabricated through conventional manufacturing methods. The fabrication steps, process parameters, design considerations, learnings, and future research directions are outlined.
增材制造是一个新兴的领域,但其在医疗微器件制造中的应用尚未得到充分的探索。传统上,医疗微设备是通过光刻、激光切割和微成型等技术的组合来制造的,这些技术共同面临着诸如多个制造步骤、有限的设计自由度、高制造成本和显著的制造时间等挑战。本文介绍了微缸光聚合作为一种替代方法来生产四种不同的微尺度医疗设备,这些设备在微流体、药物输送和生物支架方面有应用。在最小特征尺寸和分辨率方面,所提出的结构与文献引用的通过传统制造方法制造的部件相媲美,如果不是优越的话。概述了制备步骤,工艺参数,设计注意事项,学习和未来的研究方向。
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引用次数: 0
Development of a Self-Decoupled Wire-Driven Robotic Universal Joint Toward Medical Application 面向医疗应用的自解耦线驱动机器人万向节的研制
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1016
A. M. M. Bulbul Chowdhury, Jinsai Cheng, Dylan Yu, Tao Shen
Robots for surgery and rehabilitation have emerged and are gaining popularity among patients and medical doctors with their obvious benefits, such as overcoming obstacles from human users’ physical restraints, reducing physicians’ workload, and enhancing the efficacy of medical treatment. The development of medical robots meets two challenges related to their special application environments, including sterilization hazards and size/weight limitation. Medical robots (e.g., surgical robots) usually need to have close contact with human skin or organs, which need to be sterilized. However, chemical or heat sterilization on the robots poses an inevitable risk of damage on the motors, sensors, and other electronic components. The size of the surgical robot needs to be compact to gain access to surgical sites. The rehabilitation robots that patients wear have to limit their size and weight. Wire-driven actuation is a potential solution to solve these issues by avoiding the use of bulky mechanical gears and links and locating the electronic components far away from the sterilization environment. This paper presents the development of a novel wire-driven universal joint for medical robot design. With its special structure, this robotic joint has self-decoupled kinematics which can simplify its control system and increase motion accuracy. Benchtop experiments are conducted to verify the functionality of this joint and the effectiveness of its self-decoupled kinematics.
手术和康复机器人已经出现,并受到患者和医生的欢迎,因为它们具有明显的好处,例如克服了人类使用者身体限制的障碍,减轻了医生的工作量,提高了医疗效果。医疗机器人的发展面临着与其特殊应用环境相关的两个挑战,包括灭菌危害和尺寸/重量限制。医疗机器人(如外科手术机器人)通常需要与人体皮肤或器官密切接触,这些皮肤或器官需要消毒。然而,对机器人进行化学或热消毒会对电机、传感器和其他电子元件造成不可避免的损坏风险。手术机器人的尺寸需要紧凑,以便进入手术部位。病人佩戴的康复机器人必须限制它们的大小和重量。通过避免使用笨重的机械齿轮和连杆,并将电子元件放置在远离灭菌环境的地方,线驱动驱动是解决这些问题的潜在解决方案。本文介绍了一种用于医疗机器人设计的新型线驱动万向节的研制。由于其特殊的结构,该机器人关节具有自解耦的运动特性,可以简化其控制系统,提高运动精度。通过台架实验验证了该关节的功能性及其自解耦运动学的有效性。
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引用次数: 1
Assessment of Task and Joint-Based Exoskeleton Designs for Elbow Joint Rehabilitation 基于任务和关节的肘关节康复外骨骼设计评估
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1034
Pablo Delgado, Lieth Jaradat, Yimesker Yihun
Exoskeletons and robots have been used as a common practice to assist and automate rehabilitation exercises. Exoskeleton fitting and alignments are important factors and challenges that need to be addressed for smooth and safe operations and better outcomes. Such challenges often dictate the exoskeleton design approaches. Some focus on simplifying and mimicking human joints (joint-based) while others have a focus on a specific task (task-based), which does not need to align with the corresponding limb joint/s to generate the desired anatomical motion. In this study, the two design approaches are assessed in an elbow flexion-extension task. The muscle responses have been collected and compared with and without the exoskeletons. Based on 6 with no disability participants, the normalized Electromyography (EMG) RMS values are plotted. The plot profiles and magnitudes are used as a base to assess the exoskeleton alignment. For this specific task, the task-based exoskeleton has shown a profile closer to the one without exoskeleton with a relatively identical support as the joint-based one; the latter is evidenced through most subjects’ muscle response magnitudes. This preliminary data has shown a good methodology and insight towards the assessment of exoskeletons, but more human subject data is needed with different task combinations to further strengthen the findings.
外骨骼和机器人已被用作辅助和自动化康复练习的常见做法。外骨骼装配和校准是实现顺利、安全操作和更好结果所需要解决的重要因素和挑战。这些挑战往往决定了外骨骼的设计方法。一些专注于简化和模仿人类关节(基于关节),而另一些专注于特定任务(基于任务),它不需要与相应的肢体关节对齐以产生所需的解剖运动。在本研究中,两种设计方法在肘关节屈伸任务中进行评估。肌肉反应已经被收集起来,并在有外骨骼和没有外骨骼的情况下进行了比较。基于6名无残疾的参与者,绘制归一化肌电(EMG) RMS值。图的轮廓和大小被用作评估外骨骼排列的基础。对于这个特定的任务,基于任务的外骨骼已经显示出更接近于没有外骨骼的轮廓,与基于关节的外骨骼具有相对相同的支撑;后者可以通过大多数受试者的肌肉反应幅度来证明。这些初步数据显示了对外骨骼评估的良好方法和洞察力,但需要更多的人类受试者数据和不同的任务组合来进一步加强研究结果。
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引用次数: 0
Computer Vision Enabled Smart Tray for Central Venous Catheterization Training 中心静脉置管训练的计算机视觉智能托盘
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1020
Dailen C. Brown, Hang-Ling Wu, Y. Satpathy, Jessica M. Gonzalez-Vargas, Haroula M. Tzamaras, Scarlett R. Miller, J. Moore
A Computer Vision enabled Smart Tray (CVST) was designed for use in medical training for Central Venous Catheterization (CVC). The effects of background color on the ability of the computer vision algorithm to distinguish between tools and the tray was investigated. In addition, the computer vision algorithm was evaluated for accuracy in tool detection. Results indicate that a white monochromatic background is the most useful for segregating background from medical tools, and the algorithm was successfully able to detect 5 different CVC tools both individually and as a group in various arrangements, even when tools overlapped or touched. When the system was in error, it was nearly always due to one tool which has a color similar to that of the background. The CVST shows promise as a CVC training tool and demonstrates that computer vision can be used to accurately detect medical tools.
一种计算机视觉智能托盘(CVST)设计用于中心静脉置管(CVC)的医学培训。研究了背景颜色对计算机视觉算法区分工具和托盘能力的影响。此外,还对计算机视觉算法在刀具检测中的精度进行了评价。结果表明,白色单色背景对于从医疗工具中分离背景最有用,并且该算法能够成功地检测到5种不同的CVC工具,无论是单独的还是作为不同排列的一组,即使工具重叠或接触。当系统出错时,几乎总是由于一个工具的颜色与背景相似。CVST显示了作为CVC训练工具的前景,并证明了计算机视觉可以用于准确检测医疗工具。
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引用次数: 0
Reported Device Failure and the Coronavirus Pandemic: Cardiovascular Interventions 报告的器械失效和冠状病毒大流行:心血管干预
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1019
E. Zhou, S. Bhatia
Regular cardiology practices were interrupted by the COVID-19 pandemic. To better understand the pandemic’s effects on cardiology practices, we investigated whether the pandemic affected reporting of cardiovascular medical device failure by examining whether adverse event reports per week attributed to different cardiovascular devices changed significantly during the pandemic. By using data from FDA’s MAUDE database, we compared weekly rates of adverse event reports over the course of three years attributed to each of four devices: ‘Implantable Cardioverter Defibrillator (Non-CRT)’, ‘Coronary Drug-Eluting Stent’, ‘Aortic Valve, Prosthesis, Percutaneously Delivered’, and ‘Heart Valve, Non-Allograft Tissue’. Specifically, we looked at trends per week for the adverse events 'Malfunction’, ‘Injury’, and ‘Death’ for March 2018-March 2019, the pre-pandemic year of March 2019-March 2020, and the pandemic year March 2020-March 2021. We report a 46% decrease in reported deaths attributed to ICDs, a 27% decrease in reported injuries attributed to coronary DES, a 107% increase in reported deaths and a 45% increase in reported malfunctions attributed to percutaneous aortic valve prostheses, as well as a 27% decrease in reported injuries attributed to non-allograft tissue heart valves (all comparisons pandemic to pre-pandemic). That these four cardiovascular medical devices did not homogeneously increase or decrease suggests that changing care patterns that differently affected each device were the root of these trends, rather than a broader factor like underreporting which one would expect to affect the devices similarly.
正常的心脏病学实践因COVID-19大流行而中断。为了更好地了解大流行对心脏病学实践的影响,我们通过检查在大流行期间每周归因于不同心血管装置的不良事件报告是否发生显著变化,来调查大流行是否影响心血管医疗器械失效的报告。通过使用FDA MAUDE数据库的数据,我们比较了三年来四种设备的每周不良事件报告率:“植入式心律转复除颤器(非crt)”,“冠状动脉药物洗脱支架”,“主动脉瓣,假体,经皮输送”和“心脏瓣膜,非同种异体移植组织”。具体而言,我们研究了2018年3月至2019年3月、2019年3月至2020年3月的大流行前年和2020年3月至2021年3月的大流行年,每周的不良事件“故障”、“伤害”和“死亡”的趋势。我们报告了由icd引起的死亡报告减少了46%,由冠状动脉DES引起的损伤报告减少了27%,由经皮主动脉瓣假体引起的死亡报告增加了107%,由非同种异体组织心脏瓣膜引起的损伤报告增加了45%(所有的大流行与大流行前的比较)。这四种心血管医疗设备并没有均匀地增加或减少,这表明改变护理模式对每种设备的影响不同,这是这些趋势的根源,而不是一个更广泛的因素,如漏报,人们会期望对设备产生类似的影响。
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引用次数: 0
Novel Hydrogel for Stone Fragment Control During Ureteroscopic Lithotripsy 新型水凝胶用于输尿管镜碎石术中控制结石碎片
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1052
Rohan Bhattaram, Ryan J Reichert, Victoria Marino
Surgical treatment of kidney stones commonly involves ureteroscopic lithotripsy with laser-assisted stone fragmentations. Particles that remain are considered “clinically insignificant” and are left behind, though these fragments are associated with downstream complications such as infection and stone reformation. The researchers aimed to develop a novel hydrogel that would prevent stone retropulsion intraoperatively and facilitate complete fragment removal. A novel inversely thermosensitive gel was developed which would theoretically stay solid to surround kidney stone, suspend stone fragments and would become liquid for gel removal. The aim of this study was to better understand the gel delivery mechanism considering its unique thermal properties. It was hypothesized that due to the gel’s thermal properties, an active cooling method, i.e. an intracatheter cooled guide wire, would be necessary to maintain gel fluidity to reach the intended destination. The researchers designed an experiment to test gel delivery through a 5 French, 70 cm long catheter surrounded by body temperature water with and without a cooled guide wire. We found there was no significant difference between both trial groups, indicating the gel does not require an active cooling method and can be administered directly. The lack of easy-to-use and cost-effective commercially available options to effectively reduce residual stone fragments presents a path for clinical adoption of the proposed hydrogel. Future trials will look into the fluid mechanics of gel administration and potential clinical outcomes such as stone free rates and rates of complications.
肾结石的外科治疗通常包括输尿管镜碎石术和激光辅助的结石碎裂。残留的颗粒被认为是“临床无关紧要的”,并被留下,尽管这些碎片与下游并发症如感染和结石重组有关。研究人员旨在开发一种新型水凝胶,以防止术中结石的反冲,并促进碎片的完全清除。一种新型的逆热敏凝胶被开发出来,理论上它可以保持固体状态来包裹肾结石,悬浮结石碎片,然后变成液体以去除凝胶。考虑到其独特的热性能,本研究的目的是更好地了解凝胶的输送机制。据推测,由于凝胶的热特性,需要一种主动冷却方法,即导管内冷却导丝,以保持凝胶的流动性以达到预定的目的地。研究人员设计了一项实验,测试凝胶通过一根长70厘米、由体温水包围的导管输送,有或没有冷却的导丝。我们发现两个试验组之间没有显著差异,表明凝胶不需要主动冷却方法,可以直接给药。缺乏易于使用和具有成本效益的商业选择来有效地减少残留的结石碎片,这为临床采用拟议的水凝胶提供了一条途径。未来的试验将研究凝胶给药的流体力学和潜在的临床结果,如结石的游离率和并发症的发生率。
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引用次数: 0
Optimizing COVID-19 Vaccine Diffusion in Respiratory Mucosa through Stokes-Einstein Modeling Stokes-Einstein模型优化COVID-19疫苗在呼吸道粘膜中的扩散
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1065
Richard T. Zhu, S. Bhatia
SARS-COV-2 vaccines, all of which are currently intramuscular shots, have the ability to prevent serious injury. However, the absence of sufficient mucosal immunity is a major concern. To counteract this deficiency that has led to continued transmission from vaccinated individuals and breakthrough cases, reformulating vaccines to be inhalable presents a logical administration route. Predecessor research has reported the inhalable route to be viable as aerosolized vaccine nanoparticles, AAV phage nanoparticles, and PIV-5 viruses were recently identified to elicit immune responses. In this study, the diffusion of vaccine nanoparticles across the mucosa is characterized and modeled, with respect to their observed behavior from previous studies in relation to the Stokes-Einstein equation, to predict the most efficient model of an inhalable COVID-19 vaccine. The Stokes-Einstein equation has been used in several studies to predict diffusion coefficients. These predictions may be modified to fit the specifications of mucosal interactions. It was determined that mucosal interactions play a significant role in vaccine nanoparticle diffusion, as demonstrated by the viral vector and virus-like nanoparticle diffusion, and can be characterized by an equivalent hydrodynamic radius. Moreover, as a counter to mucosal interactions, PEGylation was found to drastically decrease the viscous slowing of the mucus medium.
SARS-COV-2疫苗目前都是肌肉注射,能够防止严重伤害。然而,缺乏足够的粘膜免疫是一个主要问题。这一缺陷导致了疫苗接种个体和突破性病例的持续传播,为了消除这一缺陷,将疫苗重新配制为可吸入疫苗是一种合乎逻辑的给药途径。先前的研究报道了可吸入途径是可行的,因为雾化疫苗纳米颗粒、AAV噬菌体纳米颗粒和PIV-5病毒最近被发现可引起免疫反应。在本研究中,疫苗纳米颗粒在粘膜上的扩散被表征并建模,根据先前研究中与Stokes-Einstein方程相关的观察行为,预测可吸入性COVID-19疫苗的最有效模型。斯托克斯-爱因斯坦方程在一些研究中被用来预测扩散系数。这些预测可能被修改以适应粘膜相互作用的规格。我们确定,粘膜相互作用在疫苗纳米颗粒扩散中起着重要作用,正如病毒载体和病毒样纳米颗粒扩散所证明的那样,并且可以用等效流体动力半径来表征。此外,作为对粘膜相互作用的对抗,PEGylation被发现可以显著降低黏液介质的粘性减缓。
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引用次数: 0
Fully Untethered and Stretchable Wearable Electronic Bandage for Measuring Knee Motion 用于测量膝关节运动的完全无系带和可拉伸的可穿戴电子绷带
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1026
Matthew McManigal, Renick Wilson, Patrick McManigal, Brooke Beran, E. Wellsandt, Eric J. Markvicka
Wearable electronics capable of measuring three-dimensional knee joint angle would provide new methods to predict both anterior cruciate ligament (ACL) injuries and the risk of developing early knee osteoarthritis. However, knee joint angle assessment is currently limited, due to the lack of validated wearable and untethered technologies that can be deployed in natural environments and rural or community settings. To address this challenge, we created a fully untethered, wearable electronic device to continuously measure knee joint angle using two inertial measurement unit (IMU) sensors. The wearable device is composed of a stretchable circuit assembled on a spandex-blend fabric substrate that allows the device to conform to the knee without restricting natural human movement. The fabric substrate allows the electronic circuit to be reused, while increasing the robustness of the device. Finally, we demonstrate the ability of the device to continuously measure sagittal plane knee joint angle during natural human movements outside of a laboratory environment.
能够测量三维膝关节角度的可穿戴电子设备将为预测前交叉韧带(ACL)损伤和早期膝关节骨关节炎的风险提供新的方法。然而,由于缺乏可在自然环境、农村或社区环境中部署的经过验证的可穿戴和非拴技术,膝关节角度评估目前受到限制。为了应对这一挑战,我们创造了一种完全不受束缚的可穿戴电子设备,使用两个惯性测量单元(IMU)传感器连续测量膝关节角度。该可穿戴设备由可拉伸电路组成,该电路组装在氨纶混合织物衬底上,该衬底允许该设备符合膝盖而不限制自然的人体运动。织物衬底允许电子电路被重复使用,同时增加了设备的坚固性。最后,我们展示了该设备在实验室环境之外的自然人体运动期间连续测量膝关节矢状面角度的能力。
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引用次数: 0
A Portable Robot to Perform Prostate Brachytherapy with Active Needle Steering and Robot-Assisted Ultrasound Tracking 一种便携式机器人进行前列腺近距离治疗与主动针导向和机器人辅助超声跟踪
Pub Date : 2022-04-11 DOI: 10.1115/dmd2022-1014
Mahsa Rabiei, B. Konh
Brachytherapy is an internal radiation therapy method for prostate cancer that involves placement of radioactive seeds close to the cancerous cells. Robotic needle insertion systems have been proposed in the past to help physicians to improve outcomes of brachytherapy. This work presents design and development of a portable robotic brachytherapy system to operate a tendon-driven active needle based on physician’s input. The system enables manual positioning of the needle to choose appropriate puncture positions as well as robotic manipulation mechanisms for needle insertion and bending. The system also allows for automatic movement of an ultrasound probe to visualize the needle tip in a needle insertion task in real time.
近距离放射治疗是前列腺癌的一种内部放射治疗方法,它将放射性种子放置在癌细胞附近。机器人针头插入系统在过去已经被提出,以帮助医生改善近距离治疗的结果。这项工作提出了一种便携式机器人近距离放射治疗系统的设计和开发,该系统可以根据医生的输入操作肌腱驱动的主动针。该系统可以手动定位针头以选择合适的穿刺位置,也可以通过机器人操作机制进行针头插入和弯曲。该系统还允许超声探头的自动移动,以便在插针任务中实时可视化针尖。
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引用次数: 2
期刊
2022 Design of Medical Devices Conference
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