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2023 Design of Medical Devices Conference最新文献

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NON-TRADITIONAL TRADEMARK AND DESIGN PATENT STRATEGIES FOR MEDICAL DEVICES 医疗器械非传统商标与外观设计专利策略
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-8964
Steve Baird, G. Smock, Draeke Weseman, Jake Abdo
This paper discusses non-traditional trademarks and design patents as essential Intellectual Property assets for medical device companies. The paper presents a strategy for layering the time-limited protection offered by design patents with the perpetual protection afforded to trademarks as an effective strategy for permanent exclusivity of non-functional aspects of medical device products.
本文讨论了非传统商标和外观设计专利作为医疗器械企业必不可少的知识产权资产。本文提出了一种将外观设计专利提供的限时保护与商标提供的永久保护分层的策略,作为医疗器械产品非功能方面永久排他性的有效策略。
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引用次数: 0
CREATING A FRACTURE REDUCTION AND WIRE NAVIGATION SIMULATOR FOR ORTHOPAEDIC SKILLS TRAINING AND ASSESSMENT 创建骨折复位和导线导航模拟器,用于骨科技能培训和评估
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-4204
Marcus Tatum, Steven A. Long, Don Anderson, G. Thomas
We describe a novel surgical simulator designed to train and assess an orthopaedic residents surgical skill on the tasks of fracture reduction and surgical wire navigation. We use a unique approach of combining accurate surgical models created using patient CT data along with a 3D tracking system that allows for realistic, real-time imaging along with automated performance tracking and benchmarking. Additionally, we have devised a method for tracking the surgical wire associated with the procedure to allow for a complete simulation of reducing and pinning a pediatric elbow fracture.
我们描述了一种新的手术模拟器,旨在训练和评估骨科住院医师在骨折复位和手术导线导航方面的手术技能。我们使用一种独特的方法,将使用患者CT数据创建的精确手术模型与3D跟踪系统相结合,从而实现逼真的实时成像以及自动性能跟踪和基准测试。此外,我们还设计了一种追踪与手术相关的手术线的方法,以完全模拟儿童肘部骨折的复位和固定。
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引用次数: 0
TOWARDS THE DEVELOPMENT OF A WEARABLE DEVICE TO MANAGE UPPER EXTREMITY LYMPHEDEMA 开发一种可穿戴设备来治疗上肢淋巴水肿
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-6551
L. Thomas, Seth Jarvis, Laura Wenger, Tara Newberry, Andre Muelenaer Jr., C. Arena
3 to 5 million Americans are affected by lymphedema and 140 to 200 million patients worldwide [1,2]. The chronic, progressive condition is only treatable, but not curable, leaving patients with debilitating symptoms that can significantly impair their quality of life [3]. Treatments include manual lymphatic drainage (MLD) massage and compression garments, often applied sequentially. MLD is limited by consistent access to a qualified lymphedema therapist. Our wearable device utilizes vibration to mimic the patterns of massage in MLD. The long-term goal is to enable at-home maintenance therapy between MLD sessions and improve the overall management of lymphedema. Acceleration, frequency, and sound levels of our motors were tested and compared to current clinical solutions. Acceleration testing was conducted by placing an accelerometer in a tissue model at varying distances to collect acceleration data at different duty cycles. Frequency data was calculated in MATLAB using FFT. Acceleration, sound frequency, and sound level of our motors were all within a close range of the values collected from clinical tools. The acceleration frequency of the motors rose slightly with an increased duty cycle, but did not exceed the smaller clinical tool frequency values. Based on our testing, the motors used in our device are comparable to clinical tools currently used by certified lymphedema therapists.
300万至500万美国人患有淋巴水肿,全世界有1.4亿至2亿患者[1,2]。慢性进行性疾病只能治疗,但无法治愈,患者会出现衰弱症状,严重影响他们的生活质量[3]。治疗包括手动淋巴引流(MLD)按摩和压缩服装,通常依次应用。MLD是有限的一致获得一个合格的淋巴水肿治疗师。我们的可穿戴设备利用振动来模仿MLD的按摩模式。长期目标是在MLD期间实现家庭维持治疗,并改善淋巴水肿的整体管理。我们测试了马达的加速度、频率和声级,并与目前的临床解决方案进行了比较。加速度测试通过在不同距离的组织模型中放置加速度计来收集不同占空比下的加速度数据。在MATLAB中使用FFT计算频率数据。我们的马达的加速度、声频和声级都在临床工具收集的值的接近范围内。随着占空比的增加,电机的加速频率略有上升,但不超过较小的临床工具频率值。根据我们的测试,我们设备中使用的马达与目前经认证的淋巴水肿治疗师使用的临床工具相当。
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引用次数: 0
SURROGATE MODELS OF BLOOD FLOW DYNAMICS IN BRAIN ANEURYSMS USING DYNAMIC MODE DECOMPOSITION 采用动态模态分解的脑动脉瘤血流动力学替代模型
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-8522
Trung Le, Tam Nguyen, Phat K. Huynh, T. Le
The evolution of blood flow is vital in understanding the pathogenesis of brain aneurysms. Several past studies have shown evidence for a turbulent inflow jet at the aneurysm neck. Even though there is a great need for analyzing inflow jet dynamics in clinical practice, data summarized in non-invasive modalities such as Magnetic Resonance Imaging or Computed Tomography are usually limited in spatial and temporal resolutions, and thus cannot account for the hemodynamics. In this work, Dynamic Mode Decomposition (DMD) is used to pinpoint the dominant modes of the inflow jet in patient-specific models of internal sidewall aneurysms utilizing high-resolution data from Computational Fluid Dynamics. The purpose of this thesis is to prove that the dynamic modes are not only governed by the hemodynamics of the parent artery but by the inflow jet interaction with the distal wall. Our work indicates that DMD is an essential tool for analyzing blood flow patterns of brain aneurysms and is a promising tool to be used in in-vivo context.
血流的演变对了解脑动脉瘤的发病机制至关重要。过去的几项研究表明,在动脉瘤颈部存在湍流流入射流。尽管在临床实践中非常需要分析流入射流动力学,但在磁共振成像或计算机断层扫描等非侵入性方式中总结的数据通常在空间和时间分辨率上受到限制,因此无法解释血流动力学。在这项工作中,利用计算流体动力学的高分辨率数据,动态模式分解(DMD)用于确定患者特定的内侧壁动脉瘤模型中流入射流的主要模式。本文的目的是证明血流动力学模式不仅受母动脉血流动力学的支配,而且受流入射流与远端壁相互作用的支配。我们的工作表明,DMD是分析脑动脉瘤血流模式的重要工具,是一种有希望在体内使用的工具。
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引用次数: 0
ON THE DESIGN OF A NOVEL PHONOENTEROGRAM SENSING DEVICE USING AI ASSISTED COMPUTER-AIDED AUSCULTATION 一种新型人工智能辅助计算机听诊声图传感装置的设计
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-7977
S. Damani, D. Damani, Renisha Redij, Arshia K. Sethi, Pratyusha Muddaloor, Anoushka Kapoor, Anjali Rajagopal, K. Gopalakrishnan, X. J. Wang, V. Chedid, Alexander J. Ryu, Christopher A. Aakre, S. P. Arunachalam
Bowel sounds have been previously used to study intestinal motility and overall digestive health in various clinical settings. However, the blurred definition of bowel sounds and their subtypes, limited resources for interpretation, poor sensitivity, and low positive predictive value led to their restricted utility. Recent advances in artificial intelligence and machine learning have steered interest in developing unique tools using the phonoenterogram to analyze diverse bowel sounds. In our study, bowel sounds were recorded from eight healthy volunteers using the Eko Duo stethoscope. A novel deep-learning algorithm was designed to classify the recordings into baseline or prominent bowel sounds. A total of 11,210 data points (5,605 balanced sounds) were used to train and test the model to yield an accuracy of 0.895, a precision of 0.890, and a recall of 0.854 reflecting successful segregation of these sounds into respective groups. More extensive studies enrolling healthy and diseased subjects with a device specifically tailored to record bowel sounds are needed to generalize these results and determine their application in the patient population.
在不同的临床环境中,肠道声音已经被用来研究肠道运动和整体消化系统健康。然而,肠道声音及其亚型的定义模糊,解释资源有限,灵敏度差,阳性预测值低,导致其实用性受到限制。人工智能和机器学习的最新进展引起了人们对开发独特工具的兴趣,这些工具使用声肠图来分析各种肠道声音。在我们的研究中,使用Eko Duo听诊器记录了8名健康志愿者的肠道声音。设计了一种新的深度学习算法,将录音分为基线或突出的肠道声音。总共使用了11,210个数据点(5605个平衡的声音)来训练和测试模型,得到了0.895的准确度,0.890的精度和0.854的召回率,反映了这些声音成功地分离到各自的组中。需要对健康和患病受试者进行更广泛的研究,使用专门定制的设备记录肠道声音,以推广这些结果并确定其在患者群体中的应用。
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引用次数: 0
BLOOD PRESSURE PREDICTION FROM PHOTOPLETHYSMOGRAM SIGNAL USING ARTIFICIAL INTELLIGENCE 利用人工智能从光容积图信号预测血压
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-2769
Rutuja M. Shinde, Manga Manga, Neha Muthavarapu, K. Gopalakrishnan, Christopher A. Aakre, Alexander J. Ryu, S. P. Arunachalam
Blood pressure measurement in current medical practice relies on manual methods with the most widely used modality being sphygmomanometers. Utilizing the principle of Photoplethysmography, it is possible to provide an accurate reading of one’s blood pressure through light signals and photodetector devices. This research paper introduces a new Artificial Intelligence driven approach to predict Blood pressure levels and classify them according to the updated ACC (American College of Cardiology) criteria as Normal, Elevated, Stage I, and II Hypertension from the given PPG signal values using Machine Learning Models. This research paper aims to accurately read the Systolic and Diastolic Blood Pressure using Artificial Intelligence, place them into the correct value bins and further prove that the blood pressure values differ based on different skin tones in different light wavelengths such as red, infrared, and green. Machine Learning models such as the Support Vector Machine have shown an accuracy of 70.58% for Systolic Blood Pressure and Decision Tree with an accuracy of 74.4% for Diastolic Blood Pressure classification. The models used in this research are Support Vector Machine, Decision Tree and K-Nearest Neighbor. This research study has future applications and extensions to predict blood pressure levels for patients with different skin tones under different light radiations and PPG signal readings. Neural Network models will be developed to compare the blood predictions from this work.
在目前的医疗实践中,血压测量依赖于手工方法,最广泛使用的方式是血压计。利用光电容积脉搏图的原理,可以通过光信号和光电探测器装置提供一个人的血压的准确读数。本研究介绍了一种新的人工智能驱动的方法来预测血压水平,并根据最新的ACC(美国心脏病学会)标准,根据给定的PPG信号值,使用机器学习模型将其分类为正常、升高、I期和II期高血压。本研究论文旨在利用人工智能准确读取收缩压和舒张压,并将其放入正确的数值箱中,进一步证明不同肤色在不同波长(如红光、红外线、绿光)下的血压值是不同的。支持向量机等机器学习模型显示,收缩压和决策树的准确率为70.58%,舒张压分类的准确率为74.4%。本研究使用的模型有支持向量机、决策树和k近邻。本研究在预测不同肤色患者在不同光辐射和PPG信号读数下的血压水平方面具有未来的应用和扩展。将开发神经网络模型来比较这项工作的血液预测。
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引用次数: 0
UMBRELAA: DESIGN OF A VARIABLE-SIZED LEFT ATRIAL APPENDAGE OCCLUSION DEVICE FOR STROKE PREVENTION 伞:用于预防脑卒中的可变尺寸左心耳闭塞装置的设计
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-1984
Madison Reddie, Gari Eberly, Aviva Jesse Levi, Diego Quevedo-Moreno, Keegan L. Mendez, E. Roche
Blood clots originating in the left atrial appendage (LAA) are the leading cause of ischemic stroke in patients with nonvalvular atrial fibrillation (AF). Complications from and contraindications to oral anticoagulants (OACs), in addition to the recent successes of endocardial LAA closure devices, have driven increased interest in mechanical LAA occlusion. However, current devices are limited in their abilities to accommodate diverse LAA anatomies, motivating the development of a novel endocardial LAA occluder that supports more anatomical variability. We present the design of an in-situ expandable plug as well as an accompanying pacifier module for LAA occlusion. The final design accommodates LAA diameter ranges of 14 millimeters for each device size (10-24mm and 24-38mm), double that of any approved device. This adaptability can help to overcome imperfect pre-procedural imaging and suboptimal device fit. Benchtop tug and leak tests demonstrate the stability and sealing capacities of the design.
起源于左心耳(LAA)的血凝块是导致非瓣膜性心房颤动(AF)患者缺血性卒中的主要原因。口服抗凝剂(OACs)的并发症和禁忌症,加上最近心内膜LAA闭合装置的成功,促使人们对机械LAA闭合的兴趣增加。然而,目前的设备在适应不同LAA解剖结构的能力上是有限的,这促使了新型心内膜LAA封堵器的发展,以支持更多的解剖变异性。我们提出了一种原位可膨胀塞的设计,以及一种用于LAA闭塞的伴随安抚模块。最终设计可容纳每个设备尺寸(10-24mm和24-38mm)的LAA直径范围为14毫米,是任何批准设备的两倍。这种适应性可以帮助克服不完美的术前成像和次优的设备适配。台式拖船和泄漏试验证明了该设计的稳定性和密封能力。
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引用次数: 0
DEPLOYING COMPUTER VISION DETECTION METHOD IN MEDICAL SIMULATION TRAINING USING MACHINE LEARNING 利用机器学习将计算机视觉检测方法应用于医学模拟训练
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-3868
Hang-Ling Wu, Dailen C. Brown, Scarlett R. Miller, Jason E. Moore
A machine learning (ML) object detection algorithm was developed to replace the original color-based image detection algorithm for the Dynamic Haptic Robotic Trainer Plus (DHRT+). This image recognition system was used for medical training in Central Venous Catheterization (CVC). This image tracking allows for the training system to provide accurate performance feedback to the user during the training process. The ML object detection algorithm was developed and evaluated using training data. The results indicate that increasing the training data set improves the detection system’s accuracy. The system was found to have an overall precision rate of 90.9% and a recall rate of 81.69%. This new ML model will be implemented into the DHRT+ system and used to train medical residents.
开发了一种机器学习(ML)目标检测算法,以取代原来的基于颜色的图像检测算法,用于Dynamic Haptic Robotic Trainer Plus (DHRT+)。该图像识别系统用于中心静脉置管(CVC)的医学培训。这种图像跟踪允许训练系统在训练过程中向用户提供准确的性能反馈。使用训练数据开发并评估了ML对象检测算法。结果表明,增加训练数据集可以提高检测系统的准确率。该系统的总体准确率为90.9%,召回率为81.69%。这个新的ML模型将被应用到DHRT+系统中,并用于培训住院医师。
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引用次数: 0
A LIGHTWEIGHT, FOLDABLE MOTORIZED TRANSPORT CHAIR TO EASE CAREGIVER BURDEN 一种轻便、可折叠的电动运输椅,减轻护理人员的负担
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-6138
Kimberly Gustafson, W. Durfee, Gregory O. Voss, Andrew H Hansen, G. Goldish
As the population ages, the number of caregivers in the Unites States is growing rapidly. The burden on these caregivers is exacerbated by steadily increasing obesity rates, which are highest in adults aged 50 to 70. The Caregiver-Assist Transport Chair (CATC) is designed to address the difficulty many caregivers experience assisting in the transportation of moderate to low mobility care recipients outside of the home for appointments, community engagements, or fresh air excursions. It is not uncommon for the caregiver to be elderly or of a smaller build than the care recipient, increasing the difficulty of pushing a transport chair for extended distances or across uneven or unlevel terrain. The CATC is equipped with intelligent motorized wheels that engage in the forward or reverse directions to maintain a consistently low effort required from the caregiver, independent of the weight of the care recipient. The chair assists on uphill terrain and slows on downhill descents to match the walking speed of the caregiver. In addition, the chair has a drop-down footplate mechanism that eliminates the need for the legs of the care recipient to be lifted onto foot pedals once seated. This footplate also serves as a brake to eliminate safety concerns associated with the chair rolling back as the user transitions between sitting and standing. While the CATC contains motorized elements, unlike a typical motorized wheelchair, it is lightweight, foldable, and easy to maneuver in and out of a vehicle.
随着人口老龄化,美国护理人员的数量正在迅速增长。肥胖率的稳步上升加剧了这些照顾者的负担,肥胖率在50至70岁的成年人中最高。护理人员辅助运输椅(CATC)的设计是为了解决许多护理人员在帮助中低行动能力的护理对象外出约会、社区活动或新鲜空气游览时遇到的困难。通常情况下,照顾者比被照顾者年长或身材矮小,这增加了推运输椅长距离或穿越不平坦或不平坦地形的难度。CATC配备了智能电动车轮,可以进行正向或反向操作,从而保持护理人员的低工作量,与护理对象的体重无关。这把椅子在上坡时起到辅助作用,在下坡时减慢速度,以配合护理者的行走速度。此外,椅子有一个下拉式脚踏板机构,这样就不需要在坐下后将被护理者的腿抬到脚踏板上。这个踏板还可以作为刹车,以消除用户在坐姿和站立之间转换时椅子向后滚动带来的安全问题。虽然CATC包含机动元素,但与典型的机动轮椅不同,它重量轻,可折叠,易于进出车辆。
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引用次数: 0
DESIGN OF A CUSTOM SENSING AND ACTUATING CUSHION FOR USE IN PRESSURE RELIEF IN WHEELCHAIR USERS 设计一种用于轮椅使用者减压的定制传感和驱动垫
Pub Date : 2023-04-17 DOI: 10.1115/dmd2023-6305
Jason Robinson, Vishakh H. Shewalkar, Isaiah Rigo, Asaiah Rock, Lucy Cinnamon, Daniella Chapman-Rienstra, Jooyoung Hong, Joohyung Kim, Holly M. Golecki
Pressure sores impact a wide range of individuals including wheelchair users. Solutions to address pressure sore prevention are limited. This work is aimed at developing devices to prevent pressure sores in wheelchair users with limited mobility or sensation. Informed by stakeholder input, we present a dynamic cushion design to sense areas of high pressure and actuate to relieve that pressure. We experimented using resistive sensors in a grid formation to map pressure across the seat. To relieve pressure, we propose a grid of custom pneumatic bladders to inflate in response to sensor thresholds. Bladders will inflate to redistribute pressure. After experimenting with a variety of possible bladder geometries, we selected torus-shaped actuators to optimize durability, stability, and increase breathability in the final design. Given the ability to fabricate custom bladders and program controls, the proposed device can be tailored to users’ specific needs. While static cushion solutions exist on the market, our custom design allows users to dynamically alleviate pressure eliminated the need to constantly readjust position and ultimately reduce time spent treating sores.
压疮影响广泛的个人,包括轮椅使用者。解决压疮预防的方法是有限的。这项工作的目的是开发设备,以防止压疮的轮椅使用者的行动不便或感觉有限。根据利益相关者的意见,我们提出了一种动态缓冲设计,以感知高压区域并启动以缓解该压力。我们尝试用电阻传感器在一个网格中绘制整个座椅的压力图。为了减轻压力,我们提出了一个定制的充气膀胱网格,以响应传感器阈值进行充气。膀胱会膨胀以重新分配压力。在试验了多种可能的气囊几何形状后,我们选择了环形驱动器,以优化最终设计的耐用性、稳定性和透气性。考虑到能够制造定制膀胱和程序控制,提议的设备可以根据用户的特定需求进行定制。虽然市场上存在静态缓冲解决方案,但我们的定制设计允许用户动态减轻压力,从而消除了不断调整位置的需要,最终减少了治疗疮的时间。
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引用次数: 0
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2023 Design of Medical Devices Conference
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