Ge Zhu, David Minnie, Nora Watson, Yihao Zheng, Quan Zhang
{"title":"Patient-Specific Blood Pressure Estimation Using Elastography-Integrated Arterial Tonometry: Design, Development, and Experimental Evaluation in a Phantom Model.","authors":"Ge Zhu, David Minnie, Nora Watson, Yihao Zheng, Quan Zhang","doi":"10.1115/1.4071991","DOIUrl":"10.1115/1.4071991","url":null,"abstract":"<p><p>Accurate assessment of arterial blood pressure (BP) and vascular stiffness is critical for diagnosing and monitoring cardiovascular disease. Arterial tonometry (AT) enables direct pulse wave acquisition and has been widely explored for noninvasive, continuous, wearable BP estimation. However, tonometry-based approaches typically rely on generalized arterial biomechanical parameters that exhibit substantial intersubject variability and can limit accuracy, particularly in pathological conditions. To address this limitation, we present a hybrid sensing framework that integrates shear wave elastography (SWE) with arterial tonometry to enable patient-specific biomechanical parameterization. The proposed device simultaneously acquires arterial stiffness metrics and pulse pressure waveforms, which are incorporated into a validated physics-driven model for continuous BP estimation. By combining elastography-derived mechanical priors with direct pulse wave measurements, this approach improves personalization and physiological fidelity of noninvasive, continuous BP monitoring. The proposed hybrid system demonstrates the potential for more accurate, patient-specific, and continuous blood pressure assessment, with implications for wearable cardiovascular monitoring and precision diagnostics.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 5","pages":"051008"},"PeriodicalIF":0.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148354508","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}
{"title":"Design of a Novel Insertion Training System for Central Venous Catheterization.","authors":"William Worrall, Jason Z Moore","doi":"10.1115/1.4071877","DOIUrl":"10.1115/1.4071877","url":null,"abstract":"<p><p>Central venous catheterization (CVC) is a common medical procedure with a complication rate of over 15%. Current CVC manikin-based simulators lack anatomical variation and objective feedback of user interaction skills, which greatly hinders effective skill acquisition. To address these limitations, a novel CVC insertion training system was developed and integrated with the Advanced Dynamic Haptic Robotic Trainer (DHRT+). This insertion training system contains a sensorized syringe, custom tissue phantom, and a tool detection subsystem, allowing residents to practice nearly the entire CVC procedure with realistic haptics and automated feedback on subcutaneous tool positioning. Five experiments were conducted to assess the haptic fidelity of the sensorized syringe and custom tissue and to evaluate the accuracy of subcutaneous tool detection. Results showed that the sensorized syringe, which detects aspiration and simulates arterial and venous flash, accurately reproduced clinical aspiration forces. The custom tissue phantom provided realistic force feedback during ultrasound (US) compression and needle insertion, comparable to that of commercial tissue phantoms at a substantially lower cost. The color sensors used to distinguish between inserted guidewires and catheters accurately verified tool depth and enabled tool insertion across multiple positions on the tissue surface. Overall, novel CVC insertion training system components were presented that enabled CVC simulation and provided accurate measurement on aspiration, guidewire depth, and catheter depth.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 5","pages":"051007"},"PeriodicalIF":0.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313113/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148354521","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}
Peter Connor, Joshua Gafford, Patrick Anderson, Scott Webster, S Duke Herrell, Keith L Obstein, Nithesh Kumar, Caleb Rucker, Robert J Webster
{"title":"Steerable Sheaths That Turn Endoscopes into Robotic Platforms for Colon Interventions.","authors":"Peter Connor, Joshua Gafford, Patrick Anderson, Scott Webster, S Duke Herrell, Keith L Obstein, Nithesh Kumar, Caleb Rucker, Robert J Webster","doi":"10.1115/1.4071745","DOIUrl":"10.1115/1.4071745","url":null,"abstract":"<p><p>Both the feasibility and clinical benefits of endoscopic interventions for colon lesions have been demonstrated by pioneering surgeons. Yet endoscopic approaches have not been widely deployed clinically because they are challenging to learn and perform with conventional endoscopes. Motivated by this, several robotic platforms have been created over the past few years with the goal of enhancing surgeon dexterity. To date, all such robots have used custom-made endoscopes with integrated manipulators. This typically results in robots significantly larger than conventional endoscopes, and the systems proposed would ultimately require hospitals to completely replace their conventional endoscopes with a new robotic solution, leading to undesirable cost and workflow ramifications. It has never before been possible to use conventional endoscopes directly with this type of system, because there were no robotic manipulators small, dexterous, and strong enough to pass through existing endoscope ports and enable the maneuvers needed to perform the surgery. In this paper, we show that the recent invention of steerable sheaths based on the concentric push-pull principle makes it possible to convert conventional endoscopes into multi-arm robotic platforms for colon procedures. We demonstrate our system in endoscopic submucosal dissection (ESD) in ex vivo porcine feasibility experiments. Even users with no prior experience in endoscopic submucosal dissection were able to successfully perform the procedure using our system.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 5","pages":"051004"},"PeriodicalIF":0.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148354496","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}
Nathan Tappen, Ahmad Faryami, Rajesh Kumar Madhavan, Christopher Roberts, Nicholos Popczun, Bryn A Martin, Carolyn A Harris
{"title":"The Impact of Ventricular Catheter Biomaterial Selection: Mechanical Properties and Protein Adsorption.","authors":"Nathan Tappen, Ahmad Faryami, Rajesh Kumar Madhavan, Christopher Roberts, Nicholos Popczun, Bryn A Martin, Carolyn A Harris","doi":"10.1115/1.4071990","DOIUrl":"10.1115/1.4071990","url":null,"abstract":"<p><p>Ventricular catheter (VC) obstruction remains one of the most common causes of cerebrospinal fluid (CSF) shunt failure in hydrocephalus patients. Material properties of VCs are hypothesized to contribute to failure, yet few studies have systematically compared alternative biomaterials using a consistent VC design and manufacturing process. This study aimed to evaluate the feasibility of producing VCs from a range of commercially available elastomeric biomaterials using a rapid prototyping process and subjecting VCs to testing aimed at validating mechanical and surface properties relative to a commercial VC. A lost-wax casting technique was employed to fabricate VCs from five biomaterials: three silicones of select hardness ratings, polyisoprene, and polyurethane. Biomaterial performance was assessed via standardized tests, including tear strength, raw material hardness, contact angle, fluid resistance, protein adsorption, and surface morphology. A benchtop system improved with oscillatory flow was used to assess protein adsorption. All fabricated VCs had similar dimensions to the commercial VC. Polyisoprene demonstrated the highest tear strength, while polyurethane exhibited the smoothest surface. Despite assessing VCs with different hardnesses, surface textures, and surface energy, there was no significant difference in protein adsorption. This work represents an effort that combines rapid lab-based manufacturing, VC material testing, and VC biological testing under clinically relevant flow direction and volume. In this way, this work offers new insight into new VC materials, a shift in prototype and testing protocols for VCs used in hydrocephalus, and suggests the need for environmental control and exposure in future testing to improve shunt longevity.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 5","pages":"051005"},"PeriodicalIF":0.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313133/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148354498","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}
Alex J Chiluisa, Kang Zhang, Lucas Burstein, Yao Shen, Thomas L Carroll, Yuxiang Liu, Loris Fichera
{"title":"Steerable Optical Fiber for Office-Based Laser Surgery of the Larynx: Design, Development, and Experimental Evaluation in a Phantom Model.","authors":"Alex J Chiluisa, Kang Zhang, Lucas Burstein, Yao Shen, Thomas L Carroll, Yuxiang Liu, Loris Fichera","doi":"10.1115/1.4070782","DOIUrl":"10.1115/1.4070782","url":null,"abstract":"<p><p>This paper describes the design, development, and experimental evaluation of a novel steerable optical fiber for endoscopic laser surgery. The proposed device consists of an off-the shelf optical fiber installed into a flexible sheath (outer diameter: 1.6 mm) equipped with a custom distal steering mechanism. Thanks to its compact size, the proposed device can be easily deployed through the instrument channel of most commercially available clinical endoscopes. Among the procedures where we believe the new device could be beneficial, in this paper we focus on laser surgery of the larynx, i.e., the voice box. We report experimental findings, collected in in vitro models (additively-manufactured phantoms), demonstrating that the steerable fiber significantly expands surgical access, thus enabling physicians to address disease in locations that would normally be beyond reach.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 3","pages":"031001"},"PeriodicalIF":0.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13313114/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148354500","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}
Sebastian Barrutia, Christian Knuth, Daniel Ferris
{"title":"Design and Preliminary Testing of a Lightweight and Low-Cost Knee Exoskeleton For Human Gait Assistance.","authors":"Sebastian Barrutia, Christian Knuth, Daniel Ferris","doi":"10.1115/1.4069564","DOIUrl":"https://doi.org/10.1115/1.4069564","url":null,"abstract":"<p><p>Pediatric exoskeletons have the potential to aid the walking of children with neuromuscular conditions such as crouch gait. However, current exoskeleton devices often rely on bulky batteries and motors. Recent developments in 3D-printing technologies now allow the construction of lightweight yet stiff parts that are easy to customize and use for pediatric applications. We present the mechanical design of a 3D-printed and spring-powered knee exoskeleton for gait assistance. The device had a mass of ∼1.25 kg per leg and provided a knee extensor moment during the stance phase of gait, simulating the spring-like behavior of the knee. Conversely, the exoskeleton provided no resistance during swing to allow free motion of the joint. To validate the device, we recruited two neurologically intact children to walk on a treadmill with and without the exoskeleton while we recorded kinematics, kinetics, and muscle activity data. Our exoskeleton generated knee extensor moments proportional to its angular excursion and had a peak mean moment of ∼0.1 N·m/kg during stance. Kinetic data showed that subjects decreased their biological knee moment and joint spring-like behavior to compensate for the added exoskeleton moment and stiffness, respectively. We ultimately show that the device is robust and capable of generating extensor moments comparable to devices used to assist the knee in children with crouch gait.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 2","pages":"021009"},"PeriodicalIF":0.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12849226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087836","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}
{"title":"Verification and Validation of an Autotuning Proportional-Integral-Derivative Controller for Spatially Confined Magnetic Particle Hyperthermia.","authors":"Shreeniket Pawar, Hayden Carlton, Yash Sharad Lad, Lyndsey Werhane, Ma'Moun Abu-Ayyad, Preethi Korangath, Robert Ivkov, Anilchandra Attaluri","doi":"10.1115/1.4070364","DOIUrl":"10.1115/1.4070364","url":null,"abstract":"<p><p>We have previously verified the capabilities of a prototype magnetic nanoparticle (MNP) heater (called HYPER) that can perform spatially confined heating; however, the design lacked temperature control capabilities. In this work, we designed, verified, and validated a relay-based autotuning proportional-integral-derivative (PID) controller to be used with the HYPER during in vivo experiments. The PID controller is an autotuning, relay-based controller with several design constraints: The controller must: (1) maintain tumor temperature within hyperthermic range of 41-46 °C; (2) rise time ≤ 5 min; (3) steady-state temperature must be within ±0.5 °C of the setpoint; (4) standard deviation of steady-state temperature within ±0.5 °C; and (5) temperature overshoot within 5%. The relay-based autotuning PID controller was designed in LabVIEW<sup>®</sup> with real-time thermal dose monitoring. Verification experiments were performed by heating aqueous suspensions of high-performance iron oxide MNPs. For validation, we injected the MNPs into tumor-bearing mice and analyzed the ability of the controller to maintain in vivo temperature. The results of the study show that controller was able to maintain the temperature within the hyperthermic range with a rise time ∼4 min and steady-state error ∼0.1 °C. Validation was performed on six mice, where four mice showed the temperature was maintained within design criteria and two mice partially met the design criteria. The autotuning controller can maintain the temperature within the design criteria and monitor thermal dose in real-time.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 2","pages":"021004"},"PeriodicalIF":0.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12755161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145890470","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}
Owen Kresse, Evelyn Khong, Gerhardus O Loohuis, R Elayne Shelby, Maxwell Boakye, Michael J Voor, Stuart J Williams
{"title":"Intraoperative Dual-Cantilever Probe for Rapid Measurement of Cancellous Bone Compressive Strength Within the Vertebral Body.","authors":"Owen Kresse, Evelyn Khong, Gerhardus O Loohuis, R Elayne Shelby, Maxwell Boakye, Michael J Voor, Stuart J Williams","doi":"10.1115/1.4070666","DOIUrl":"https://doi.org/10.1115/1.4070666","url":null,"abstract":"<p><p>Dual X-ray absorptiometry (DEXA) scans are the current standard in assessing bone mineral density (BMD) and are used to identify patients who may need screw augmentation during spinal fusion. DEXA scans are not always available and tend to overestimate BMD. This paper describes the development of a dual-cantilever mechanical probe and tested in polyurethane foam blocks with varying compressive strengths. The probe was modeled after a 5.5 mm tap and foam block holes were prepared replicating intra-operative conditions. Calibration curves were acquired for each probe using six foam blocks (1.5-12.9 MPa). Verification tests were performed in a different set of four foam blocks (2.05-9.65 MPa). Four probes were machined and tested for repeatability. Three users separately acquired measurements of foam blocks to test for reliability. The root-mean-square error of all four probes measuring the 2.05 MPa, 3.65 MPa, 5.80 MPa, and 9.65 MPa samples were 0.89 MPa, 0.32 MPa, 1.41 MPa, and 1.71 MPa, respectively. There was not a significant difference between different probes or different users. The dual-cantilever probe provided measurements within the clinically relevant range of compressive strengths for vertebral trabecular bone. A targeted and reliable bone strength measurement technique could reduce the occurrence and revision surgeries and improve patient outcomes.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"20 2","pages":"021010"},"PeriodicalIF":0.7,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12849225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087789","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}
Miguel A Martinez, Seungil Kim, Johannes Bonatti, William R Wagner, Cameron N Riviere
{"title":"Design and Validation of a Recirculating Cooling System for Robotic Cardiac Injection Therapy to Improve Patient Safety and Surgeon Workflow.","authors":"Miguel A Martinez, Seungil Kim, Johannes Bonatti, William R Wagner, Cameron N Riviere","doi":"10.1115/1.4068896","DOIUrl":"10.1115/1.4068896","url":null,"abstract":"<p><p>HeartLander is a miniature mobile robot designed to navigate on the surface of the heart using a crawling motion and is well-suited for delivering myocardial injections. Previous work has incorporated a cooling system to enable delivery of a thermally responsive anti-ventricular remodeling hydrogel to a target injection site. However, the previous setup required the saline coolant to be discharged at the distal end of the system and into the patient's pericardial space, hindering the hydrogel from forming a deposit at the target site, presenting an additional burden to the surgeon's workflow, and increasing the risk to the patient. To prevent this, we redesigned the system to include a return channel for the coolant, which discharges to a reservoir outside the patient. We validated this design with a multiphysics simulation, static water bath tests, and by demonstration of controlled injections in an ovine heart ex vivo at 37°C.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"19 4","pages":""},"PeriodicalIF":0.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12851536/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087833","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}
Jingsen Ma, Chao-Tsung Hsiao, Aswin Gnanaskandan, Xiaolong Deng
{"title":"MBaFus: A Virtual Lab of Microbubble-Augmented Focused Ultrasound for Noninvasive Tumor Ablation Based on Two-Way Coupled Euler-Lagrange Modeling.","authors":"Jingsen Ma, Chao-Tsung Hsiao, Aswin Gnanaskandan, Xiaolong Deng","doi":"10.1115/1.4068489","DOIUrl":"10.1115/1.4068489","url":null,"abstract":"<p><p>Focused ultrasound (FUS), especially when augmented by microbubbles (MBs), shows the potential for noninvasive ablation of deep-seated tumors, but its clinical adoption is hindered due to its dependency on multiple controllable parameters of FUS and MBs. To accelerate the clinical transition of this noninvasive and target therapy, a virtual lab featuring a two-way coupled Euler-Lagrange computation platform, capable of capturing physics down to individual MBs thus their nonlinear interactions, has been developed to accurately predict the acoustic and thermal fields for microbubble-augmented FUS (MBaFus), and subsequently the resultant temperature rise at the treatment spots. This technical brief concisely summarizes the main features of its numerical algorithms for prediction and high-performance computing schemes for speedup, as well as its preliminary validation against in vitro experiments. Recent progress on further evaluating the numerical virtual lab under ex vivo settings is reported, where FUS treatment for ex vivo porcine liver was conducted and MB augmentation effects to treatment outcome under different MB conditions were compared. It is found that the agreement between our numerical prediction and experimental measurements in the referred ex vivo study is reasonably satisfactory. Though more extensive validations are needed when extra ex vivo studies in the public domain become available, this intermediate progress illustrates the potential of this novel numerical platform serving as a virtual lab of microbubble-augmented FUS for noninvasive tumor ablation.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":"19 3","pages":"034501"},"PeriodicalIF":0.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12147931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267794","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}