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  • 刊频： Quarterly
  • NLM标题： J Med Device
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  • 1.

    【2hr】Disposable Fluidic Actuators for Miniature In-Vivo Surgical Robotics

    包量

    机译 用于微型体内手术机器人的一次性流体执行器
    摘要：Fusion of robotics and minimally invasive surgery (MIS) has created new opportunities to develop diagnostic and therapeutic tools. Surgical robotics is advancing from externally actuated systems to miniature in-vivo robotics. However, with miniaturization of electric-motor-driven surgical robots, there comes a trade-off between the size of the robot and its capability. Slow actuation, low load capacity, sterilization difficulties, leaking electricity and transferring produced heat to tissues, and high cost are among the key limitations of the use of electric motors in in-vivo applications. Fluid power in the form of hydraulics or pneumatics has a long history in driving many industrial devices and could be exploited to circumvent these limitations. High power density and good compatibility with the in-vivo environment are the key advantages of fluid power over electric motors when it comes to in-vivo applications. However, fabrication of hydraulic/pneumatic actuators within the desired size and pressure range required for in-vivo surgical robotic applications poses new challenges. Sealing these types of miniature actuators at operating pressures requires obtaining very fine surface finishes which is difficult and costly. The research described here presents design, fabrication, and testing of a hydraulic/pneumatic double-acting cylinder, a limited-motion vane motor, and a balloon-actuated laparoscopic grasper. These actuators are small, seal-less, easy to fabricate, disposable, and inexpensive, thus ideal for single-use in-vivo applications. To demonstrate the ability of these actuators to drive robotic joints, they were modified and integrated in a robotic arm. The design and testing of this surgical robotic arm are presented to validate the concept of fluid-power actuators for in-vivo applications.
  • 2.

    【2hr】Liquid Handling Optimization in High-Throughput Biodosimetry Tool

    包量

    机译 高通量生物剂量测定工具中的液体处理优化
    摘要：Due to the need of high-speed and efficient biodosimetric assays for triage and therapy in the event of radiological or nuclear attack, a robotically based automated biodosimetry tool (RABiT) has been developed over the past few years. Adapting the micronucleus assay from filter plates to V-shaped plates presented challenges in the liquid handling, namely, cell splashing out of the V-shaped well plate during the cell harvesting, poor cell distribution on the bottom of the image plate during the dispensing, and cell loss from the image plate during the aspiration in the liquid handling process. Experimental and numerical investigations were carried out to better understand the phenomena and mitigate the problems. Surface tension and contact angle among the fluids and the plate wall were accounted for in the discrete and multiphase numerical models. Experimental conditions were optimized based on the numerical results showing the relationship between nozzle speed and amount of splashed liquid, and the relationship between aspiration speed and number of escaped cells. Using these optimized parameters, numbers of micronuclei in binucleated cells showed the same dose dependence in the RABiT-prepared samples as those in the manually prepared ones. Micronucleus assay protocol was fully realized on RABiT.
  • 3.

    【2hr】A Virtual Reality Haptic Robotic Simulator for Central Venous Catheterization Training

    包量

    机译 用于中央静脉导管插入训练的虚拟现实触觉机器人模拟器
    摘要：
  • 4.

    【2hr】Velocity-Limiting Control of an Active Handheld Micromanipulator

    包量

    机译 有源手持式微操纵器的速度限制控制
    摘要：
  • 5.

    【2hr】Coating Techniques and Release Kinetics of Drug-Eluting Stents

    包量

    机译 药物洗脱支架的涂层技术和释放动力学
    摘要：Implantation of drug-eluting stents (DESs) via percutaneous coronary intervention is the most popular treatment option to restore blood flow to occluded vasculature. The many devices currently used in clinic and under examination in research laboratories are manufactured using a variety of coating techniques to create the incorporated drug release platforms. These coating techniques offer various benefits including ease of use, expense of equipment, and design variability. This review paper discusses recent novel DES designs utilizing individual or a combination of these coating techniques and their resulting drug release profiles.
  • 6.

    【2hr】Sensorless Force Sensing for Minimally Invasive Surgery

    包量

    机译 微创手术的无传感器力感测
    摘要：Robotic minimally invasive surgery (R-MIS) has achieved success in various procedures; however, the lack of haptic feedback is considered by some to be a limiting factor. The typical method to acquire tool–tissue reaction forces is attaching force sensors on surgical tools, but this complicates sterilization and makes the tool bulky. This paper explores the feasibility of using motor current to estimate tool-tissue forces and demonstrates acceptable results in terms of time delay and accuracy. This sensorless force estimation method sheds new light on the possibility of equipping existing robotic surgical systems with haptic interfaces that require no sensors and are compatible with existing sterilization methods.
  • 7.

    【2hr】A Compact Bone-Attached Robot for Mastoidectomy

    包量

    机译 紧凑的用于骨骼切除术的骨骼附着机器人
    摘要：Otologic surgery often involves a mastoidectomy, which is the removal of a portion of the mastoid region of the temporal bone, to safely access the middle and inner ear. The surgery is challenging because many critical structures are embedded within the bone, making them difficult to see and requiring a high level of accuracy with the surgical dissection instrument, a high-speed drill. We propose to automate the mastoidectomy portion of the surgery using a compact, bone-attached robot. The system described in this paper is a milling robot with four degrees-of-freedom (DOF) that is fixed to the patient during surgery using a rigid positioning frame screwed into the surface of the bone. The target volume to be removed is manually identified by the surgeon pre-operatively in a computed tomography (CT) scan and converted to a milling path for the robot. The surgeon attaches the robot to the patient in the operating room and monitors the procedure. Several design considerations are discussed in the paper as well as the proposed surgical workflow. The mean targeting error of the system in free space was measured to be 0.5 mm or less at vital structures. Four mastoidectomies were then performed in cadaveric temporal bones, and the error at the edges of the target volume was measured by registering a postoperative computed tomography (CT) to the pre-operative CT. The mean error along the border of the milled cavity was 0.38 mm, and all critical anatomical structures were preserved.
  • 8.

    【2hr】Design of Novel Mixer and Applicator for Two-Component Surgical Adhesives

    包量

    机译 新型两组分手术胶粘剂混合器和涂布器的设计
    摘要：Current mixer and applicator devices on the market are not able to properly and efficiently mix two-component surgical adhesives in small volumes necessary to achieve economic viability. Furthermore, in these devices a significant amount of adhesive is wasted during the application process, as material within the dead space of the mixing chamber must be discarded. We have designed and demonstrated a new active mixer and applicator system capable of rapidly and efficiently mixing two components of an adhesive and applying it to the surgical site. Recently, Messersmith et al. have developed a tissue adhesive inspired by the mussel byssus and have shown that it is effective as a surgical sealant, and is especially suited for wet environments such as in fetal surgery. Like some other tissue sealants, this one requires that two components of differing viscosities be thoroughly mixed within a specified and short time period. Through a combination of compression and shear testing, we demonstrated that our device could effectively mix the adhesive developed by Messersmith et al. and improve its shear strength to significantly higher values than what has been reported for vortex mixing. Overall, our mixer and applicator system not only has potential applications in mixing and applying various adhesives in multiple surgical fields but also makes this particular adhesive viable for clinical use.
  • 9.

    【2hr】An On-Site Thermoelectric Cooling Device for Cryotherapy and Control of Skin Blood Flow

    包量

    机译 用于冷冻疗法和控制皮肤血流量的现场热电冷却装置
    摘要：Cryotherapy involves the surface application of low temperatures to enhance the healing of soft tissue injuries. Typical devices embody a remote source of chilled water that is pumped through a circulation bladder placed on the treatment site. In contrast, the present device uses thermoelectric refrigeration modules to bring the cooling source directly to the tissue to be treated, thereby achieving significant improvements in control of therapeutic temperature while having a reduced size and weight. A prototype system was applied to test an oscillating cooling and heating protocol for efficacy in regulating skin blood perfusion in the treatment area. Data on 12 human subjects indicate that thermoelectric coolers (TECs) delivered significant and sustainable changes in perfusion for both heating (increase by (±SE) 173.0 ± 66.0%, P < 0.005) and cooling (decrease by (±SE) 57.7 ± 4.2%, P < 0.0005), thus supporting the feasibility of a TEC-based device for cryotherapy with local temperature regulation.
  • 10.

    【2hr】A Passive Parallel Master–Slave Mechanism for Magnetic Resonance Imaging-Guided Interventions

    包量

    机译 磁共振成像引导干预的被动并行主从机制
    摘要：A passive, parallel master–slave mechanism is presented for magnetic resonance imaging (MRI)-guided interventions in the pelvis. The mechanism allows a physician to stand outside the MRI scanner while manipulating a needle inside the bore and, unlike a powered robot, does not place actuators in proximity to the patient. The manipulator combines two parallel mechanisms based on the Delta robot architecture. The mechanism also includes a two-axis gimbal to allow for tool angulation, giving a total of five degrees of freedom so that the physician can insert and steer a needle using continuous natural arm and wrist movements, unlike simple needle guides. The need for access between the patient’s legs and within the MRI scanner leads to an unusual asymmetric design in which the sliding prismatic joints form the vertices of an isosceles triangle. Kinematic analysis shows that the dexterity index of this design is improved over the desired workspace, as compared to an equilateral design. The analysis is extended to estimate the effect of friction and model the input:output force transmission. Prototypes, with final dimensions selected for transperineal prostate interventions, showed force transmission behavior as predicted by simulation, and easily withstood maximum forces required for tool insertion.
  • 11.

    【2hr】Low Cost Magnetic Resonance Imaging-Compatible Stepper Exercise Device for Use in Cardiac Stress Tests

    包量

    机译 适用于心脏压力测试的低成本磁共振成像兼容步进运动设备
    摘要：Cardiovascular disease is the leading cause of death worldwide. Many cardiovascular diseases are better diagnosed during a cardiac stress test. Current approaches include either exercise or pharmacological stress echocardiography and pharmacological stress magnetic resonance imaging (MRI). MRI is the most accurate noninvasive method of assessing cardiac function. Currently there are very few exercise devices that allow collection of cardiovascular MRI data during exercise. We developed a low-cost exercise device that utilizes adjustable weight resistance and is compatible with magnetic resonance (MR) imaging. It is equipped with electronics that measure power output. Our device allows subjects to exercise with a leg-stepping motion while their torso is in the MR imager. The device is easy to mount on the MRI table and can be adjusted for different body sizes. Pilot tests were conducted with 5 healthy subjects (3 male and 2 female, 29.2 ± 3.9 yr old) showing significant exercise-induced changes in heart rate (+42%), cardiac output (+40%) and mean pulmonary artery (PA) flow (+%49) post exercise. These data demonstrate that our MR compatible stepper exercise device successfully generated a hemodynamically stressed state while allowing for high quality imaging. The adjustable weight resistance allows exercise stress testing of subjects with variable exercise capacities. This low-cost device has the potential to be used in a variety of pathologies that require a cardiac stress test for diagnosis and assessment of disease progression.
  • 12.

    【2hr】Development and Validation of Endovascular Chemotherapy Filter Device for Removing High-Dose Doxorubicin: Preclinical Study

    包量

    机译 去除大剂量阿霉素的血管内化疗过滤器装置的开发和验证：临床前研究
    摘要：To develop a novel endovascular chemotherapy filter (CF) able to remove excess drug from the blood during intra-arterial chemotherapy delivery (IAC), thus preventing systemic toxicities and thereby enabling higher dose IAC. A flow circuit containing 2.5 mL of ion-exchange resin was constructed. Phosphate-buffered saline (PBS) containing 50 mg doxorubicin (Dox) was placed in the flow model with the hypothesis that doxorubicin would bind rapidly to resin. To simulate IAC, 50 mg of doxorubicin was infused over 10 min into the flow model containing resin. Similar testing was repeated with porcine serum. Doxorubicin concentrations were measured over 60 min and compared to controls (without resin). Single-pass experiments were also performed. Based on these experiments, an 18F CF was constructed with resin in its tip. In a pilot porcine study, the device was deployed under fluoroscopy. A control hepatic doxorubicin IAC model (no CF placed) was developed in another animal. A second CF device was created with a resin membrane and tested in the infrarenal inferior vena cava (IVC) of a swine. In the PBS model, resin bound 76% of doxorubicin in 10 min, and 92% in 30 min (P  <  0.001). During IAC simulation, 64% of doxorubicin bound in 10 min and 96% in 60 min (P  <  0.001). On average, 51% of doxorubicin concentration was reduced during each pass in single pass studies. In porcine serum, 52% of doxorubicin bound in 10 min, and 80% in 30 min (P  <  0.05). CF device placement and administration of IAC were successful in three animals. No clot was present on the resin within the CF following the in vivo study. The infrarenal IVC swine study demonstrated promising results with up to 85% reduction in peak concentration by the CF device. An endovascular CF device was developed and shown feasible in vitro. An in vivo model was established with promising results supporting high-capacity rapid doxorubicin filtration from the blood that can be further evaluated in future studies.
  • 13.

    【2hr】A System for Optimizing Medical Device Development Using Finite Element Analysis Predictions

    包量

    机译 基于有限元分析预测的医疗器械开发优化系统
    摘要：
  • 14.

    【2hr】The Vascular Model Repository: A Public Resource of Medical Imaging Data and Blood Flow Simulation Results

    包量

    机译 血管模型资料库：医学影像数据和血流模拟结果的公共资源
    摘要：Patient-specific blood flow simulations may provide insight into disease progression, treatment options, and medical device design that would be difficult or impossible to obtain experimentally. However, publicly available image data and computer models for researchers and device designers are extremely limited. The National Heart, Lung, and Blood Institute sponsored Open Source Medical Software Corporation (contract nos. HHSN268200800008C and HHSN268201100035C) and its university collaborators to build a repository () including realistic, image-based anatomic models and related hemodynamic simulation results to address this unmet need.
  • 15.

    【2hr】Patient-Specific Finite Element Simulations of Standard Incisional Astigmatism Surgery and a Novel Patterned Collagen Crosslinking Approach to Astigmatism Treatment

    包量

    机译 标准切开散光手术的患者特定有限元模拟和新颖的图案化胶原蛋白交联方法治疗散光
    摘要：
  • 16.

    【2hr】Blood Damage Quantification in Cardiovascular Flows Through Medical Devices Using a Novel Suspension Flow Method

    包量

    机译 使用新型悬浮流方法对通过医疗器械的心血管流中的血液损害进行量化
    摘要：
  • 17.

    【2hr】Open Knee: A Pathway to Community Driven Modeling and Simulation in Joint Biomechanics

    包量

    机译 张开膝盖：社区驱动的联合生物力学建模和仿真的途径。
    • 作者：Ahmet Erdemir
    • 刊名：Journal of Medical Devices
    • -1年第4期
    摘要：
  • 18.

    【2hr】Development of a Portable Knee Rehabilitation Device That Uses Mechanical Loading

    包量

    机译 使用机械负载的便携式膝盖康复设备的开发
    摘要：Joint loading is a recently developed mechanical modality, which potentially provides a therapeutic regimen to activate bone formation and prevent degradation of joint tissues. To our knowledge, however, few joint loading devices are available for clinical or point-of-care applications. Using a voice-coil actuator, we developed an electromechanical loading system appropriate for human studies and preclinical trials that should prove both safe and effective. Two specific tasks for this loading system were development of loading conditions (magnitude and frequency) suitable for humans, and provision of a convenient and portable joint loading apparatus. Desktop devices have been previously designed to evaluate the effects of various loading conditions using small and large animals. However, a portable knee loading device is more desirable from a usability point of view. In this paper, we present such a device that is designed to be portable, providing a compact, user-friendly loader. The portable device was employed to evaluate its capabilities using a human knee model. The portable device was characterized for force-pulse width modulation duty cycle and loading frequency properties. The results demonstrate that the device is capable of producing the necessary magnitude of forces at appropriate frequencies to promote the stimulation of bone growth and which can be used in clinical studies for further evaluations.
  • 19.

    【2hr】Performance of Biopsy Needle With Therapeutic Injection System to Prevent Bleeding Complications

    包量

    机译 治疗性注射系统活检针预防出血并发症的性能
    摘要：Renal disease is epidemic in the United States with approximately 8 × 106 people having chronic kidney disease. Renal biopsies are widely used to provide essential diagnostic information to physicians. However, the risk of bleeding complications possibly leading to life-threatening situations results in the contra-indication of biopsy in certain patient populations. Safer renal biopsies will allow more accurate diagnosis and better management of this epidemic health problem. We report the preclinical testing of a novel biopsy device called the therapeutic injection system (TIS). The device introduces a third stage to the standard two-stage side-cut percutaneous biopsy process. The third stage is designed to reduce bleeding complications by injecting a hemostatic plug at the time of biopsy. Laboratory evaluation and preliminary in vivo animal testing using an anticoagulated porcine model of the TIS and Bard Monopty® (Bard Medical, Covington, GA) control device were performed. The hemostatic material Gelfoam® (Pfizer, Brussels, Belgium) was selected as the active material comprising the hemostatic plugs. The performance of two composite plugs, one composed of polyvinyl alcohol (PVA) combined in 2:1 and 12:1 ratios with the hemostatic material, and one plug composed of 100% hemostatic material were tested. Stroke sequence and hemostatic plug deployment were verified by sequential firing of the TIS biopsy needle into clear gelatin and ex vivo bovine kidney specimens. In vivo trials with porcine specimens revealed a significant reduction in blood loss (8.1 ± 3.9 ml, control versus 1.9 ± 1.6 ml, 12:1 PVA/hemostatic, TIS, α = 0.01, n = 6). The 100% hemostatic plug showed a substantial and immediate reduction in blood loss (9.2 ml, control versus 0.0 ml, TIS, n = 1). The prototype device was shown to work repeatedly and reliably in laboratory trials. Initial results show promise in this approach to control post biopsy bleeding. This solution maintains the simplicity and directness of the percutaneous approach, while not significantly changing the standard percutaneous biopsy procedure.
  • 20.

    【2hr】Mock Circulatory Loop Compliance Chamber Employing a Novel Real-Time Control Process

    包量

    机译 模拟循环回路遵从室采用新型实时控制过程
    摘要：The use of compliance chambers in mock circulatory loop construction is the predominant means of simulating arterial compliance. Utilizing mock circulatory loops as bench test methods for cardiac assist technologies necessitates that they must be capable of reproducing the circulatory conditions that would exist physiologically. Of particular interest is the ability to determine instantaneous compliance of the system, and the ability to change the compliance in real-time. This capability enables continuous battery testing of conditions without stopping the flow to change the compliance chamber settings, and the simulation of dynamic changes in arterial compliance. The method tested involves the use of a compliance chamber utilizing a circular natural latex rubber membrane separating the fluid and air portions of the device. Change in system compliance is affected by the airspace pressure, which creates more reaction force at the membrane to the fluid pressure. A pressure sensor in the fluid portion of the chamber and a displacement sensor monitoring membrane center deflection allow for real-time inputs to the control algorithm. A predefined numerical model correlates the displacement sensor data to the volume displacement of the membrane. The control algorithm involves a tuned π loop maintaining the volume distention of the membrane via regulation of the air space pressure. The proportional integral (PI) controller tuning was achieved by creating a computational model of the compliance chamber using Simulink™ Simscape® toolboxes. These toolboxes were used to construct a model of the hydraulic, mechanical, and pneumatic elements in the physical design. Parameter Estimation™ tools and Design Optimization™ methods were employed to determine unknown physical parameters in the system, and tune the process controller used to maintain the compliance setting. It was found that the resulting control architecture was capable of maintaining compliance along a pressure-volume curve and allowed for changes to the compliance set point curve without stopping the pulsatile flow.
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