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iQbD: a TRL-indexed Quality-by-Design Paradigm for Medical Device Engineering iQbD:一种TRL索引的医疗器械工程质量设计范式
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2022-02-01 DOI: 10.1115/1.4053721
T. Bastogne
Risk assessment is a critical step in the roadmap of medical device development. Failure modes, effects and criticality analysis is a common approach based on declarative prior information that proved beneficial in the risk assessment of well established processes. But at early steps of development when innovative materials or technologies are embedded, the lack of experience on those innovations introduces too much subjectivity in FMECA for a robust risk assessment. Since mid-2000, the Quality-by-Design guideline has been proposed within the pharmaceutical industry as a proactive engineering approach of drug development. This paradigm enables a data-driven risk assessment throughout the development workflow, which completes risk assessment provided by FMECA. Nevertheless, its implementation guide is unclear and not flexible enough to be efficiently applied to the development of medical devices. To address this issue, a new QbD paradigm indexed on the technological readiness level of the innovative product is proposed. It covers the development of medical devices throughout the whole preclinical phase and is composed of at least nine learning cycles. The first part of this medical device QbD layout, composed of three consecutive risk assessment cycles, is evaluated through a real study case with the objective to demonstrate the proof of concept of a photobleaching controller in photodynamic therapy. Beyond this experimental result, this application has confirmed practical ability of the iQbD approach to complete FMECA and to provide an alternative solution to risk assessment when prior knowledge on the technological innovation is not available.
风险评估是医疗器械开发路线图中的关键一步。失效模式、影响和关键性分析是一种基于声明性先验信息的常用方法,事实证明,这种方法对已建立的过程的风险评估是有益的。但在开发的早期阶段,当嵌入创新材料或技术时,这些创新经验的缺乏在FMECA中引入了太多主观性,无法进行稳健的风险评估。自2000年年中以来,制药行业提出了设计质量指南,作为药物开发的一种积极工程方法。这种模式能够在整个开发工作流程中进行数据驱动的风险评估,从而完成FMECA提供的风险评估。然而,其实施指南尚不明确,不够灵活,无法有效应用于医疗器械的开发。为了解决这个问题,提出了一种新的基于创新产品技术准备水平的QbD范式。它涵盖了整个临床前阶段的医疗器械开发,至少由九个学习周期组成。该医疗器械QbD布局的第一部分由三个连续的风险评估周期组成,通过一个真实的研究案例进行评估,目的是证明光漂白控制器在光动力治疗中的概念验证。除了这一实验结果之外,该应用程序还证实了iQbD方法在没有技术创新的先验知识的情况下完成FMECA并为风险评估提供替代解决方案的实际能力。
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引用次数: 3
Development and Validation of a Physiological Testing Method for Sternal Closure Systems 胸骨闭合系统生理测试方法的开发与验证
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2022-01-26 DOI: 10.1115/1.4053687
Annette Kienle, Nadine Renner, Constanze Bischoff
After a median sternotomy, the sternal bone has to be refixated using implants such as wires, plates or clamps. However, there is still a lack of specifically applicable test methods to investigate the mechanical safety and effectiveness of such implant systems. The aim of this study was to develop a new test method that replicates the in vivo loads acting on the sternum and that is applicable to all types of sternal closure systems. Based on the scientific literature a setup was developed that incorporates the physiological loads acting on the sternum during breathing (91 N) and coughing (328 N). These loads are applied to a sternum replicate at 5 Hz for approximately 1.8 million cycles. This cycle number is assumed to represent the healing period. For validation, the new method was applied to two different sternal closure systems: a PEEK clamp system and wires. The new test method proved to be easily applicable. The validation tests with the two sternal closure systems showed reasonable and reproducible results regarding all outcome parameters. The pre-tension exerted by the implants significantly differed between the two implant groups and decreased after the first coughing cycles. The fracture gap separation during breathing also significantly different between the two test groups but it was similar during coughing. No implant failed. Using this new test method it is possible to compare sternal closure systems under reproducible conditions and interpret their mechanical characteristics regarding their in vivo safety and effectiveness.
胸骨正中切开术后,胸骨必须用金属丝、钢板或夹子等植入物进行再固定。然而,仍然缺乏专门适用的测试方法来研究这种植入系统的机械安全性和有效性。本研究的目的是开发一种新的测试方法,该方法可以复制作用在胸骨上的体内负荷,并适用于所有类型的胸骨闭合系统。在科学文献的基础上,开发了一种装置,该装置结合了呼吸(91牛)和咳嗽(328牛)时作用于胸骨的生理负荷。这些负荷以5赫兹的频率在胸骨上重复约180万次。这个周期数被假定为表示治疗周期。为了验证,新方法应用于两种不同的胸骨闭合系统:PEEK夹紧系统和钢丝。新的测试方法被证明是易于应用的。两种胸骨闭合系统的验证试验在所有结局参数方面显示出合理和可重复的结果。两组患者的预张力差异显著,且在第一次咳嗽后降低。呼吸时骨折间隙分离在两组之间也有显著差异,但在咳嗽时相似。没有植入失败。使用这种新的测试方法,可以在可重复的条件下比较胸骨闭合系统,并解释其体内安全性和有效性的机械特性。
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引用次数: 0
Patient-Customised Theatre Mattress Supports for Spinal Surgery: A Pilot Study Presenting a Novel Engineering Virtual Design and Manufacturing Technique 脊柱外科患者定制的剧院床垫支架:一项新的工程虚拟设计和制造技术的初步研究
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2022-01-19 DOI: 10.1115/1.4053604
J. P. Little, D. Green, M. Izatt, Gregory Moloney, G. Askin
Optimal patient positioning for spine surgery is vital for surgical success and the minimisation of complications intra-/post-operatively. In patients with complex co-morbidities, commercially available surgical positioning equipment is inadequate. To overcome this, a novel method was developed to create custom-fit patient-specific theatre mattresses for patients undergoing spine surgery. An innovative digital workflow involving 3D surface scanning, 3D simulation and computer aided design was developed to manufacture customised theatre supports with patient-specific requirements. These supports offered the surgeon an enhanced ability to relieve load bearing on prominent anatomical features or where desired, to tailor the support surface to the patient's anatomy for lengthy surgery. The bespoke theatre mattress was evaluated by whether the support resulted in a complication-free surgery. Using this new workflow, case examples for two patients with complex co-morbidities were described. The spine surgeon and anaesthetist reported the patient-specific custom mattresses were fit as per the required design, provided sufficient clearance around anatomical prominences and areas that required to be unloaded, had sufficient clearance for the anaesthetic method and cannulation, provided excellent surgical access and stability during surgery, and postoperatively no soft tissue overload over bony prominence and implanted devices. Positive patient outcomes after successful lengthy surgical interventions were associated with these patient-specific, contoured mattress supports. Future projects will seek to utilise this technology for other types of surgeries and intra-operative positioning requirements, and for a broader demographic of patients in both the paediatric and adult setting.
脊柱手术患者的最佳体位对手术成功和减少术中/术后并发症至关重要。对于有复杂合并症的患者,市售的手术定位设备是不够的。为了克服这一问题,研究人员开发了一种新方法,为接受脊柱手术的患者定制适合患者的剧院床垫。创新的数字工作流程包括3D表面扫描、3D模拟和计算机辅助设计,以制造符合患者特定要求的定制手术室支架。这些支撑为外科医生提供了一种增强的能力,可以减轻突出解剖特征上的负荷,或者在需要的地方,根据患者的解剖结构定制支撑表面,以进行长时间的手术。通过支持是否导致无并发症的手术来评估定制的剧院床垫。利用这一新的工作流程,描述了两例复杂合并症患者的病例。脊柱外科医生和麻醉师报告说,患者定制的床垫符合要求的设计,在解剖突起和需要卸载的区域周围提供足够的间隙,为麻醉方法和插管提供足够的间隙,在手术过程中提供良好的手术通路和稳定性,术后没有软组织超载在骨突起和植入装置上。在成功的长时间手术干预后,积极的患者结果与这些患者特定的、轮廓的床垫支撑有关。未来的项目将寻求将这项技术用于其他类型的手术和术中定位要求,并用于儿科和成人环境中更广泛的患者。
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引用次数: 0
Evaluation of a Pneumatic Vest to Treat Symptoms of ARDS Caused by COVID-19 气动背心治疗COVID-19引起的ARDS症状的评价
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-27 DOI: 10.1115/1.4053387
Alexander B. Ambrose, Joshua F. Detelich, M. Weinmann, F. Hammond
Critical care patients who experience symptoms of acute respiratory distress syndrome are commonly placed on mechanical ventilators to increase the oxygen provided to their pulmonary systems and monitor their condition. With the pulmonary inflammation typically accompanying ARDS, patients can experience lower ventilation-perfusion ratios resulting in lower blood oxygenation. In these cases, patients are typically rotated into a prone position to facilitate improved blood flow to portions of the lung that were not previously participating in the gas exchange process. However, proning a patient increases the risk of complications, requires up to seven hospital staff members to carry out, and does not guarantee an improvement in the patient's condition. The low-cost vest presented here was designed to reproduce the effects of proning while also requiring less hospital staff than the proning process. Additionally, the V/Q Vest helps hospital staff predict whether patients would respond well to a proning treatment. A pilot study was conducted on nine patients with ARDS from Coronavirus disease 2019 (COVID-19). The average increase in oxygenation with the V/Q Vest treatment for all patients was 19.7 ± 38.1%. Six of the nine patients responded positively to the V/Q Vest treatment, exhibiting increased oxygenation. The V/Q Vest also helped hospital staff predict that three of the five patients that were proned would experience an increase in oxygenation. An increase in oxygenation resulting from V/Q Vest treatment exceeded that of the proning treatment in two of these five proned patients.
出现急性呼吸窘迫综合征症状的重症监护患者通常使用机械呼吸机,以增加向肺系统提供的氧气并监测其病情。急性呼吸窘迫综合征通常伴有肺部炎症,患者通气灌注比较低,导致血液氧合降低。在这种情况下,患者通常被旋转成俯卧位,以促进血液流向先前不参与气体交换过程的肺部分。然而,为病人做手术会增加并发症的风险,需要多达七名医院工作人员来执行,而且不能保证病人的病情得到改善。这里展示的低成本背心是为了重现俯卧过程的效果,同时也比俯卧过程需要更少的医院人员。此外,V/Q背心可以帮助医院工作人员预测患者对长期治疗的反应是否良好。对9例2019冠状病毒病(COVID-19)急性呼吸窘迫综合征患者进行了初步研究。V/Q Vest治疗组患者氧合平均增加19.7±38.1%。9名患者中有6名对V/Q Vest治疗反应积极,表现出氧合增加。V/Q背心还帮助医院工作人员预测,五名患者中有三名会出现氧合增加。在这5例易感患者中,有2例因V/Q Vest治疗导致的氧合增加超过了易感治疗。
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引用次数: 1
Preoperative Motion Planner for Steerable Needles Using Cost Map Based on Repulsive Field and Empirical Model of Needle Deflection 基于斥力场成本图和针偏转经验模型的可操纵针术前运动规划
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-16 DOI: 10.1115/1.4053285
Shan Jiang, Bowen Jiang, Peina Fang, Zhiyong Yang
Needle insertion is a common procedure in percutaneous puncture. A motion planner for a steerable needle that considers the risk level of the path in anatomical environment and the actual deflection of clinical needle is necessary. A novel preoperative motion planner for a steerable needle controlled by robot is proposed. Our method utilizes sampling-based planner to compute candidate path in the reachable region, the path solutions are optimized by calculating the cost of a path based on a cost map. The cost-map, which is built based on repulsive field theory from CT image, encodes the information of the obstacle locations and the criticality of the anatomical environment. The empirical formula that can predict needle trajectory is obtained by insertion experiments. Experiments shown that positioning error in gelatin phantom under the guidance of our planner is less than 1.1mm. Comparing with the straight-line insertion method, the positioning error was reduced by 80%. The results indicate that the motion planner has the potential to provide effective guidance for robot-assisted puncture surgery while enhancing the position precision and patient safety.
在经皮穿刺中,针的插入是一种常见的方法。考虑解剖环境下路径的危险程度和临床针的实际偏转,设计可操纵针的运动规划是必要的。提出了一种新的机器人可操纵针术前运动规划方法。该方法利用基于采样的规划器在可达区域内计算候选路径,并基于代价图计算路径的代价来优化路径解。该代价图是基于CT图像的斥力理论构建的,对障碍物位置信息和解剖环境的临界性信息进行编码。通过插针实验,得到了预测针迹轨迹的经验公式。实验表明,在规划器的指导下,明胶体的定位误差小于1.1mm。与直线插入法相比,定位误差减小了80%。结果表明,该运动规划器可为机器人辅助穿刺手术提供有效指导,同时提高定位精度和患者安全性。
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引用次数: 2
Design and Initial Validation of a Multiple Degree-of-Freedom Joint for an Ankle-Foot Orthosis 踝足矫形器多自由度关节的设计与初步验证
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-11 DOI: 10.1115/1.4053200
Toby Elery, Emma Reznick, Staci M. Shearin, Karen J. McCain, R. Gregg
This paper presents the novel design of a Multi-Degree-Of-Freedom joint (M-DOF) for an Ankle-Foot Orthosis (AFO) that aims to improve upon the commercially available Double Action Joint (DAJ). The M-DOF is designed to maintain the functionality of the DAJ, while increasing dorsiflexion stiffness and introducing inversion/eversion. This increase in range of motion is designed to produce greater engagement from lower limb muscles during gait. The M-DOF was experimentally validated with one able-bodied and one stroke subject. Across walking speeds, the M-DOF AFO minimally affected the able-bodied subject's joint kinematics. The stroke subject's ankle dorsiflexion/plantarflexion and knee flexion were not heavily altered when wearing the M-DOF AFO, compared to the DAJ AFO. The new DOF allowed by the M-DOF AFO increased the inversion/eversion of the ankle by ~3°, without introducing any new compensations compared to their gait with the DAJ AFO.
本文提出了一种用于踝足矫形器(AFO)的多自由度关节(M-DOF)的新颖设计,旨在改进商用双动关节(DAJ)。M-DOF旨在保持DAJ的功能,同时增加背屈刚度并引入倒置/外翻。这种运动范围的增加是为了在步态过程中使下肢肌肉产生更大的参与。M-DOF在一名健全和一名中风受试者身上进行了实验验证。在步行速度上,M-DOF AFO对健全受试者的关节运动学影响最小。与DAJ AFO相比,当佩戴M-DOF AFO时,中风受试者的踝关节背屈/跖屈和膝关节屈曲没有严重改变。M-DOF AFO允许的新DOF将脚踝的内翻/外翻增加了约3°,与DAJ AFO的步态相比,没有引入任何新的补偿。
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引用次数: 2
RestEaze: An Emerging Technology to Characterize Leg Movements During Sleep RestEaze:一种描述睡眠中腿部运动的新兴技术
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-06 DOI: 10.1115/1.4053160
Justin Brooks, C. Feltch, J. Lam, C. Earley, R. Robucci, Sanjay Agarwal, Nilanjan Banerjee
Several sleep disorders are characterized by periodic leg movements during sleep including Restless Leg Syndrome, and can indicate disrupted sleep in otherwise healthy individuals. Current technologies to measure periodic leg movements during sleep are limited. Polysomnography and some home sleep tests use surface electromyography to measure electrical activity from the anterior tibilias muscle. Actigraphy uses 3-axis accelerometers to measure movement of the ankle. Electromyography misses periodic leg movements that involve other leg muscles and is obtrusive because of the wires needed to carry the signal. Actigraphy based devices require large amplitude movements of the ankle to detect leg movements (missing the significant number of more subtle leg movements) and can be worn in multiple configurations precluding precision measurement. These limitations have contributed to their lack of adoption as a standard of care for several sleep disorders. In this study, we develop the RestEaze sleep assessment tool as an ankle-worn wearable device that combines capacitive sensors and a 6-axis inertial measurement unit to precisely measure periodic leg movements during sleep. This unique combination of sensors and the form-factor of the device addresses current limitations of periodic leg movements during sleep measurement techniques. Pilot data collected shows high correlation with polysomnography across a heterogeneous participant sample and high usability ratings. RestEaze shows promise in providing ecologically valid, longitudinal measures of leg movements that will be useful for clinicians, researchers, and patients to better understand sleep.
一些睡眠障碍的特征是睡眠中周期性的腿部运动,包括不宁腿综合征,这可能表明在其他健康个体中睡眠中断。目前测量睡眠期间腿部周期性运动的技术是有限的。多导睡眠图和一些家庭睡眠测试使用表面肌电图来测量胫骨前肌的电活动。活动记录仪使用3轴加速度计来测量脚踝的运动。肌电图忽略了涉及其他腿部肌肉的周期性腿部运动,并且由于需要携带信号的电线而显得突兀。基于活动仪的设备需要踝关节的大幅度运动来检测腿部运动(忽略了大量更细微的腿部运动),并且可以在多种配置中佩戴,从而妨碍了精确测量。这些限制导致它们没有被采纳为治疗几种睡眠障碍的标准。在这项研究中,我们开发了RestEaze睡眠评估工具,作为一种踝关节穿戴式可穿戴设备,它结合了电容传感器和6轴惯性测量单元,以精确测量睡眠期间的周期性腿部运动。这种独特的传感器组合和设备的形状因素解决了当前睡眠测量技术中周期性腿部运动的局限性。收集的试点数据显示,在异质参与者样本和高可用性评级中,多导睡眠图具有高度相关性。RestEaze有望为临床医生、研究人员和患者更好地了解睡眠提供生态学上有效的、纵向的腿部运动测量。
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引用次数: 1
Using Smartphones for Clinical Assessment in Cervical Spondylotic Myelopathy a Feasibility Study. 使用智能手机进行脊髓型颈椎病临床评估的可行性研究。
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-01 Epub Date: 2021-10-22 DOI: 10.1115/1.4052609
Julien Francisco Zaldivar-Jolissaint, François Lechanoine, Bernard Krummenacher, Rivus Ferreira Arruda, Lukas Bobinski, Emmanuel de Schlichting, John Michael Duff

Degenerative cervical myelopathy (DCM) is characterized by a progressive deterioration in spinal cord function. Its evaluation requires subjective clinical examination with wide interobserver variability. Objective quantification of spinal cord function remains imprecise, even though validated myelopathy-grading scales have emerged and are now widely used. We created a Smartphone Application, the N-Outcome App, with the aim of quantifying accurately and reliably spinal cord dysfunction using a 5-minute Test. A patient suffering from DCM was clinically evaluated before surgery, at 3 and 6 months follow-up after surgical decompression of the cervical spinal cord. Standard scores (Nurick grade, modified Japanese Orthopedic Association (mJOA) score) were documented at these time points. A 5-minute motor and proprioceptive performance test aided by a smartphone with the N-outcome App was also performed. Motor performance in rapid alternating movements and finger tapping improved in correlation with improvements in standard grading scale scores. Clinical improvements were seen in maximum reflex acceleration and in Romberg testing which showed less closed/open eyes variation, suggesting pyramidal and proprioceptive function recovery. We demonstrate that using the N-Outcome App as an adjunct to clinical evaluation of compressive myelopathy is feasible and potentially useful. The results correlate with the results of clinical assessment obtained by standard validated myelopathy scores.

退行性脊髓型颈椎病(DCM)以脊髓功能进行性恶化为特征。它的评价需要主观的临床检查和广泛的观察者之间的差异。脊髓功能的客观量化仍然不精确,即使有效的脊髓病分级量表已经出现,现在广泛使用。我们创建了一个智能手机应用程序,N-Outcome应用程序,目的是通过5分钟的测试准确可靠地量化脊髓功能障碍。对1例DCM患者术前、颈脊髓减压术后随访3个月和6个月进行临床评估。在这些时间点记录标准评分(Nurick评分,修改的日本骨科协会(mJOA)评分)。在带有N-outcome App的智能手机的辅助下,还进行了5分钟的运动和本体感觉性能测试。快速交替运动和手指敲击的运动表现与标准评分量表得分的提高相关。在最大反射加速和Romberg测试中观察到临床改善,闭/睁眼变化较少,表明锥体和本体感觉功能恢复。我们证明,使用N-Outcome App作为临床评估压缩性脊髓病的辅助手段是可行的,并且可能有用。结果与通过标准验证的脊髓病评分获得的临床评估结果相关。
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引用次数: 1
Apparatus for In Vivo Knee Laxity Assessment Using High-Speed Stereo Radiography. 高速立体放射摄影在体膝关节松弛度评估装置。
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-01 Epub Date: 2021-09-10 DOI: 10.1115/1.4051834
Thor E Andreassen, Landon D Hamilton, Donald Hume, Sean E Higinbotham, Yashar Behnam, Chadd Clary, Kevin B Shelburne

Computational modeling is of growing importance in orthopedics and biomechanics as a tool to understand differences in pathology and predict outcomes from surgical interventions. However, the computational models of the knee have historically relied on in vitro data to create and calibrate model material properties due to the unavailability of accurate in vivo data. This work demonstrates the design and use of a custom device to quantify anterior-posterior (AP) and internal-external (IE) in vivo knee laxity, with an accuracy similar to existing in vitro methods. The device uses high-speed stereo radiography (HSSR) tracking techniques to accurately measure the resulting displacements of the femur, tibia, and patella bones during knee laxity assessment at multiple loads and knee flexion angles. The accuracy of the knee laxity apparatus was determined by comparing laxity data from two cadaveric specimens between the knee laxity apparatus and an existing in vitro robotic knee joint simulator. The accuracy of the knee laxity apparatus was within 1 mm (0.04 in.) for AP and 2.5 deg for IE. Additionally, two living subjects completed knee laxity testing to confirm the laboratory use of the novel apparatus. This work demonstrates the ability to use custom devices in HSSR to collect accurate data, in vivo, for calibration of computational models.

计算建模在骨科和生物力学中越来越重要,它是一种理解病理差异和预测手术干预结果的工具。然而,由于无法获得准确的体内数据,膝关节的计算模型一直依赖于体外数据来创建和校准模型材料特性。这项工作展示了定制设备的设计和使用,以量化体内前后(AP)和内外(IE)膝关节松弛,其准确性与现有的体外方法相似。该设备采用高速立体x线摄影(HSSR)跟踪技术,在多种负荷和膝关节屈曲角度下评估膝关节松弛时,精确测量股骨、胫骨和髌骨的位移。通过比较两具尸体标本的松弛数据,确定了膝关节松弛仪的准确性。膝关节松弛仪的精度AP在1毫米(0.04英寸)以内,IE在2.5度以内。此外,两名活着的受试者完成了膝关节松弛测试,以确认实验室使用这种新型仪器。这项工作证明了在HSSR中使用定制设备收集准确数据的能力,在体内,用于校准计算模型。
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引用次数: 2
Preliminary Evaluation of Hydraulic Needle Delivery System for Magnetic Resonance Imaging-Guided Prostate Biopsy Procedures 磁共振成像引导前列腺活检液压针头输送系统的初步评价
IF 0.9 4区 医学 Q3 Medicine Pub Date : 2021-12-01 DOI: 10.1115/1.4051610
D. I. Mahcicek, Korel D. Yildirim, Gokce Kasaci, O. Kocaturk
In clinical routine, the prostate biopsy procedure is performed with the guidance of transrectal ultrasound (TRUS) imaging to diagnose prostate cancer. However, the TRUS-guided prostate biopsy brings reliability concerns due to the lack of contrast difference between prostate tissue and lesions. In this study, a novel hydraulic needle delivery system that is designed for performing magnetic resonance imaging (MRI)-guided prostate biopsy procedure with transperineal approach is introduced. The feasibility of the overall system was evaluated through in vitro phantom experiments under an MRI guidance. The in vitro experiments performed using a certified prostate phantom (incorporating MRI visible lesions). MRI experiments showed that overall hydraulic biopsy needle delivery system has excellent MRI compatibility (signal to noise ratio (SNR) loss < 3%), provides acceptable targeting accuracy (average 2.05±0.46 mm) and procedure time (average 40 min).
在临床常规中,前列腺活检程序是在经直肠超声(TRUS)成像的指导下进行的,以诊断前列腺癌症。然而,由于前列腺组织和病变之间缺乏对比度差异,TRUS引导的前列腺活检带来了可靠性问题。在这项研究中,介绍了一种新型的液压针头输送系统,该系统旨在通过会阴入路进行磁共振成像(MRI)引导的前列腺活检程序。在MRI指导下,通过体外体模实验评估了整个系统的可行性。使用经认证的前列腺模型(包括MRI可见病变)进行的体外实验。MRI实验表明,整个液压活检针输送系统具有良好的MRI兼容性(信噪比(SNR)损失 < 3%),提供可接受的瞄准精度(平均2.05±0.46 mm)和手术时间(平均40 分钟)。
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引用次数: 0
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Journal of Medical Devices-Transactions of the Asme
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