Journal of Medical Devices-Transactions of the Asme最新文献

Mechanical Viability and Functionality Assessment of a New Sutureless Endoluminal Microvascular Device: A Preliminary In Vivo Rabbit Study. 新型无缝线腔内微血管装置的机械活力和功能评估：兔子体内初步研究。

IF 0.8 4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2025-03-01 Epub Date: 2024-10-22 DOI: 10.1115/1.4066555

Jordi Descarrega, Joan Fontdevila, Erica Segura, Héctor Oyonate, German Bellemi, Brittany Taylor

{"title":"Mechanical Viability and Functionality Assessment of a New Sutureless Endoluminal Microvascular Device: A Preliminary In Vivo Rabbit Study.","authors":"Jordi Descarrega, Joan Fontdevila, Erica Segura, Héctor Oyonate, German Bellemi, Brittany Taylor","doi":"10.1115/1.4066555","DOIUrl":"10.1115/1.4066555","url":null,"abstract":"Our group has developed a new nitinol endoluminal self-expandable device for microvascular anastomosis. It attaches to each vessel ending with opposite directed microspikes and reaches complete expansion at body temperature, using the nitinol shape memory capacity. The main purpose of this first in vivo trial is to evaluate the mechanical viability of the device and its immediate and early functionality. A recuperation study with seven New Zealand White rabbits was designed. A 1.96 mm outer diameter prototype of the new device was placed on the right femoral artery of each rabbit. Each anastomosis was reassessed on the seventh postoperative day to reevaluate the device function. The average anastomosis time with the new device was 18 min and 45 seg (±0.3 seg). It could be easily placed in all the cases with an average of 1.14 (1) complementary stitches needed to achieve a sealed anastomosis. Patency test was positive for all the cases on the immediate assessment. On the 1 week revision surgery, patency test was negative for the seven rabbits due to blood clot formation inside the device. The new device that we have developed is simple to use and shows correct immediate functionality. On the early assessment, the presence of a foreign body in the endoluminal space caused blood clot formation. We speculate that a heparin eluting version of the device could avoid thrombosis formation. We consider that the results obtained can be valuable for other endoluminal sutureless devices.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Design and Implementation of a Computer-Controlled Hybrid Oscillatory Ventilator. 计算机控制的混合振荡通风机的设计与实施。

IF 0.8 4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2025-03-01 Epub Date: 2024-10-22 DOI: 10.1115/1.4066679

Andrea F Cruz, Jacob Herrmann, Bakir Hajdarevic, Monica L Hawley, Donald Fox, Jason H T Bates, David W Kaczka

{"title":"Design and Implementation of a Computer-Controlled Hybrid Oscillatory Ventilator.","authors":"Andrea F Cruz, Jacob Herrmann, Bakir Hajdarevic, Monica L Hawley, Donald Fox, Jason H T Bates, David W Kaczka","doi":"10.1115/1.4066679","DOIUrl":"10.1115/1.4066679","url":null,"abstract":"During mechanical ventilation, lung function and gas exchange in structurally heterogeneous lungs may be improved when volume oscillations at the airway opening are applied at multiple frequencies simultaneously, a technique referred to as multifrequency oscillatory ventilation (MFOV). This is in contrast to conventional high-frequency oscillatory ventilation (HFOV), for which oscillatory volumes are applied at a single frequency. In the present study, as a means of fully realizing the potential of MFOV, we designed and tested a computer-controlled hybrid oscillatory ventilator capable of generating the flows, tidal volumes, and airway pressures required for MFOV, HFOV, conventional mechanical ventilation (CMV), as well as oscillometric measurements of respiratory impedance. The device employs an iterative spectral feedback controller to generate a wide range of oscillatory waveforms. The performance of the device meets that of commercial mechanical ventilators in volume-controlled mode. Oscillatory modes of ventilation also meet design specifications in a mechanical test lung, over frequencies from 4 to 20 Hz and mean airway pressure from 5 to 30 cmH2O. In proof-of-concept experiments, the oscillatory ventilator maintained adequate gas exchange in a porcine model of acute lung injury, using combinations of conventional and oscillatory ventilation modalities. In summary, our novel device is capable of generating a wide range of conventional and oscillatory ventilation waveforms with potential to enhance gas exchange, while simultaneously providing less injurious ventilation.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142516706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Controlled Ice Nucleation With a Sand-PDMS Film Device Enhances Cryopreservation of Mouse Preantral Ovarian Follicles. 利用 Sand-PDMS 薄膜装置控制冰核形成可提高小鼠前卵巢卵泡的冷冻保存效果。

IF 0.8 4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2024-12-01 Epub Date: 2024-09-30 DOI: 10.1115/1.4066445

Samantha Stewart, Alisa White, Wenquan Ou, Wei Liu, Jennifer Nagashima, Nucharin Songsasen, Xiaoming He

{"title":"Controlled Ice Nucleation With a Sand-PDMS Film Device Enhances Cryopreservation of Mouse Preantral Ovarian Follicles.","authors":"Samantha Stewart, Alisa White, Wenquan Ou, Wei Liu, Jennifer Nagashima, Nucharin Songsasen, Xiaoming He","doi":"10.1115/1.4066445","DOIUrl":"10.1115/1.4066445","url":null,"abstract":"Ovarian follicle cryopreservation is a promising strategy for fertility preservation; however, cryopreservation protocols have room for improvement to maximize post-thaw follicle viability and quality. Current slow-freezing protocols use either manual ice-seeding in combination with expensive programmable-rate freezers or other clinically incompatible ice initiators to control the ice-seeding temperature in the extracellular solution, a critical parameter that impacts post-cryopreservation cell/tissue quality. Previously, sand has been shown to be an excellent, biocompatible ice initiator, and its use in cryopreservation of human induced pluripotent stem cells enables high cell viability and quality after cryopreservation. This study applies sand as an ice initiator to cryopreserve multicellular microtissue, preantral ovarian follicles, using a simple slow-freezing protocol in the mouse model. Ovarian follicles cryopreserved using the sand partially embedded in polydimethylsiloxane (PDMS) film to seed ice in the extracellular solution exhibit healthy morphology, high viability, and the ability to grow similarly to fresh follicles in culture post-thaw. This sand-based cryopreservation strategy can facilitate convenient ovarian follicle cryopreservation using simple equipment, and this study further demonstrates the translatability of this strategy to not only single cells but also multicellular tissues.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Novel Design Method for the Knee Joint of the Exoskeleton Based On the Modular Wearable Sensor 基于模块化可穿戴传感器的外骨骼膝关节设计新方法

4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-10-07 DOI: 10.1115/1.4063672

Jian Cao, Chang Wang, Jianhua Zhang, Kexiang Li, Jianjun Zhang

{"title":"A Novel Design Method for the Knee Joint of the Exoskeleton Based On the Modular Wearable Sensor","authors":"Jian Cao, Chang Wang, Jianhua Zhang, Kexiang Li, Jianjun Zhang","doi":"10.1115/1.4063672","DOIUrl":"https://doi.org/10.1115/1.4063672","url":null,"abstract":"Abstract This paper innovatively proposes an artificial knee joint customization design scheme based on modular wearable sensors. It aims to solve the compatibility and security problem of wearable devices for different individual knee joints. The method consists of two main parts: measurement and customization. A wearable sensor with three joints is proposed and analyzed. The sensor can measure the kinematic characteristics of human knee joints to obtain the customized design parameters of artificial joints. Designed a bionic four-link knee joint, and the parameters of the connecting rod were optimized by a genetic algorithm based on the measured data. In particular, the measuring device and knee joint are designed in a modular way, and they can be used on the same platform. The modular design method can be used to customize joints for different individuals, which simplifies the difficulty of customization and effectively reduces the cost. After the modular knee joint's optimized design, this paper mainly conducted a number of comparative tests. The comparative test results of three joints show that the dynamic tracking accuracy of customized joints is 54.9% higher than that of ordinary joints and 70.5% higher than that of hinge joints. The results show that personalized customization for individuals can improve human-machine coupling performance.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135254599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Experimental Investigation of the Calcified Plaque Material Removal Rate in Coronary Rotational Atherectomy 冠脉旋转动脉粥样硬化切除术中钙化斑块材料去除率的实验研究

4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-10-07 DOI: 10.1115/1.4063671

Xinxiao Li, Jiaqi Yang, Patrick Chernjavsky, Katerina Angjeli, Yang Liu, Yihao Zheng

{"title":"Experimental Investigation of the Calcified Plaque Material Removal Rate in Coronary Rotational Atherectomy","authors":"Xinxiao Li, Jiaqi Yang, Patrick Chernjavsky, Katerina Angjeli, Yang Liu, Yihao Zheng","doi":"10.1115/1.4063671","DOIUrl":"https://doi.org/10.1115/1.4063671","url":null,"abstract":"Abstract Rotational atherectomy (RA) is a minimally invasive procedure to remove the calcified atherosclerotic plaque from arteries to restore blood flow. It uses a high-speed, metal-bonded diamond abrasive grinding wheel to pulverize the calcified plaque into absorbable debris via a catheter through the artery. Although RA has been clinically used for over two decades, procedural complications persist and there remains a lack of consensus on the optimal device parameters. This study aims to investigate RA material removal rate (MRR) with respect to grinding wheel sizes and rotational speeds based on a tissue-mimicking phantom. Three grinding wheel sizes, 1.25, 1.5, and 1.75 mm in diameter, and three rotational speeds, 120,000, 150,000, and 180,000 rpm, were investigated. The RA MRR was presented as the luminal area gain and measured by microscopy and image processing. The results show the increase of the grinding wheel size or rotational speed leads to a higher MRR and luminal gain in RA. With a 1.75 mm diameter grinding wheel rotating at 180,000 rpm in a 2 mm initial diameter lumen, the max MRR and the luminal gain are 2.49 mm2/(three passes) and 5.09 mm2, respectively. The MRR decreases as the number of grinding passes increases during RA with the same grinding wheel rotating at a constant speed. This study provides a thorough understanding of the wheel size and speed effects on RA MRR for improvements in RA devices and clinical operational guidelines.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135254788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessment of a Novel Application of the Capture-Trap-Terminate Approach for Treating Aerosol Products During Dental Procedures 评估捕获-捕获-终止方法在牙科过程中处理气溶胶产品的新应用

4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-09-16 DOI: 10.1115/1.4063457

Muh Anshar, Erni Marlina, Yossy Yoanita, Muhammad Ruslin, Dewiani Djamaluddin, Muhammad Arsyad Thaha, Muhammad Rusman, Andi Sitti Hajrah Yusuf

引用次数: 0

Development And Mechanical Testing Of Implant For Cranial Reconstruction After Burr Hole Trepanation 钻孔后颅骨重建种植体的研制及力学性能测试

IF 0.9 4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-09-04 DOI: 10.1115/1.4063344

Julia Bodnarova, Adam Kratochvil, Matej Daniel

{"title":"Development And Mechanical Testing Of Implant For Cranial Reconstruction After Burr Hole Trepanation","authors":"Julia Bodnarova, Adam Kratochvil, Matej Daniel","doi":"10.1115/1.4063344","DOIUrl":"https://doi.org/10.1115/1.4063344","url":null,"abstract":"\u0000 Burr hole trepanation is a surgical procedure in which one or more small holes, or trephines, are made in the skull to allow for the drainage of fluids or to relieve pressure within the skull. Burr hole trepanation is generally considered a safe and effective treatment for conditions such as brain abscesses and subdural hematomas. However, the bone defects must be closed after the surgery with a suitable implant. Current designs are mostly based on bone plates with limited lifetime, revision access, and low aesthetic. Within this study, a new type of cranial implant is proposed made using additive manufacturing (AM) techniques. The implant is anchored in the burr hole and does not penetrate the skull space or prominate the skull. Four different types of implants have been proposed on the basis of an analytical model and verified using finite element analysis (FEA). New push-in mechanical tests are introduced using artificial bone to determine the strength of the locking mechanisms and ensure the safety of implants. The burr-hole implant with an overlap on the bone surface after implantation was proven to be the safest solution. The design of the new cranial implant can significantly improve the aesthetic outcome after surgery and minimize invasiveness in reoperations.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2023-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43064307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Preliminary Assessment of a Laparoscopic Training System Using Magneto-Rheological Clutches and Virtual Reality 基于磁流变离合器和虚拟现实的腹腔镜训练系统的初步评估

4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-09-01 DOI: 10.1115/1.4063389

Bruno-Pier Busque, Louis-Philippe Lebel, Yves Collin, Jean-Sébastien Plante

{"title":"Preliminary Assessment of a Laparoscopic Training System Using Magneto-Rheological Clutches and Virtual Reality","authors":"Bruno-Pier Busque, Louis-Philippe Lebel, Yves Collin, Jean-Sébastien Plante","doi":"10.1115/1.4063389","DOIUrl":"https://doi.org/10.1115/1.4063389","url":null,"abstract":"Abstract Although laparoscopy has revolutionized modern medicine, its training remains long and complex due to reduced haptic feedback and loss of depth perception. Training also poses an ethical challenge when performed on living patients, and access to cadavers is becoming rare and difficult. In the early 2000s, medical simulators began to appear to help mitigate these problems: virtual reality simulators (VRS) and physical reality simulators (PRS). Current VRS can provide guidance and performance evaluation with fewer instructors but are expensive and bulky. PRS, on the other hand, are less expensive, compact and offer haptic feedback through real physical interactions with mockup objects. However, they require guidance from an instructor, and cannot provide objective assessment or complex and realistic surgical scenarios. This paper assesses the potential of a VRS based on magneto-rheological (MR) actuators that could offer the haptic capabilities of current VRS with the size envelopes of PRS. Technical specifications for a laparoscopic VRS are extracted from the literature, a prototype is built and evaluated experimentally. In addition, three simulation scenarios are built and presented to surgeons to confirm simulation capabilities. In its current form, the MR-powered prototype is shown to meet targeted functional specifications but future work is needed to reduce friction, reduce size, and optimize packaging.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135248680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

In Vitro Thrombogenicity Testing of Biomaterials in a Dynamic Flow Loop: Effects of Length and Quantity of Test Samples. 动态流动环路中生物材料的体外血栓形成性测试：测试样本长度和数量的影响。

IF 0.8 4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-09-01 Epub Date: 2023-07-25 DOI: 10.1115/1.4062863

Megan A Jamiolkowski, Madelyn D Golding, Richard A Malinauskas, Qijin Lu

{"title":"In Vitro Thrombogenicity Testing of Biomaterials in a Dynamic Flow Loop: Effects of Length and Quantity of Test Samples.","authors":"Megan A Jamiolkowski, Madelyn D Golding, Richard A Malinauskas, Qijin Lu","doi":"10.1115/1.4062863","DOIUrl":"10.1115/1.4062863","url":null,"abstract":"The results of in vitro dynamic thrombogenicity testing of biomaterials and medical devices can be significantly impacted by test conditions. To develop and standardize a robust dynamic in vitro thrombogenicity tool, the key test parameters need to be appropriately evaluated and optimized. We used a flow loop test system previously developed in our laboratory to investigate the effects of sample length and the number of samples per test loop on the thrombogenicity results. Porcine blood heparinized to a donor-specific target concentration was recirculated at room temperature through polyvinyl chloride (PVC) tubing loops containing test materials for 1 h at 200 mL/min. Four test materials (polytetrafluoroethylene (PTFE), latex, PVC, and silicone) with various thrombotic potentials in two sample lengths (12 and 18 cm) were examined. For the 12-cm long materials, two different test configurations (one and two samples per loop) were compared. Thrombogenicity was assessed through percent thrombus surface coverage, thrombus weight, and platelet count reduction in the blood. The test system was able to effectively differentiate the thrombogenicity profile of the materials (latex > silicone > PVC ≥ PTFE) at all test configurations. Increasing test sample length by 50% did not significantly impact the test results as both 12 and 18 cm sample lengths were shown to equally differentiate thrombotic potentials between the materials. The addition of a second test sample to each loop did not increase the test sensitivity and may produce confounding results, and thus a single test sample per loop is recommended.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10405281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10319263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Novel Quasilinear Viscoelastic Model of the Bending of a Steerable Catheter 一种新型的可操纵导管弯曲拟线性粘弹性模型

IF 0.9 4区医学

Journal of Medical Devices-Transactions of the Asme Pub Date : 2023-08-23 DOI: 10.1115/1.4063215

Jajun Ryu, Jung-Hwa Ahn, Hwa-Young Kim

引用次数: 0