{"title":"Development of a pO<sub>2</sub>-Guided Fine Needle Tumor Biopsy Device.","authors":"Robert C McDonald","doi":"10.1115/1.4052900","DOIUrl":"https://doi.org/10.1115/1.4052900","url":null,"abstract":"<p><p>Tumor biopsies are an important aspect of oncology providing a guide for medical treatment and evaluation of disease progression. Highly heterogenous tumors have complex regions of active cancer cells interdigitated with necrotic tissue and healthy noncancerous tissue. The reliable access to tumor tissue pathology is therefore challenging and usually requires multiple needle insertions with accompanying patient discomfort and risk of infection. Oxygen levels provide a means of detecting and evaluating tumor tissue with levels reduced by 2-fold to 22-fold, depending on the type of organ. However, if the biopsy needle is placed in an area of normal tissue, there is always a chance that no diagnostic cells will be acquired for meaningful pathology and molecular analysis. While not the case in all tumors, there are cases where the in vivo oxygen levels differ with tumor cells having a value of pO<sub>2</sub> lying between the anoxic necrotic tissue and normoxic normal tissue. The level of oxygen in tumor cells can also vary with time as related to complex biochemical pathways. The efficacy of radiation therapy is also sensitive to oxygen levels in tumors. Lower levels of oxygen present greater resistance to treatment. To address these concerns, a pO<sub>2</sub>-guided biopsy needle (OGBN) was developed to determine oxygen levels and fluctuations in highly resolved regions of tumors, in order to aide in determining the optimal region for cell sampling help in determining medical treatment options.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822461/pdf/med-21-1061_021003.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9547340","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}
Jacob F Oeding, Sam Bockman, Harriet Chiu, Cheyenne Hua, James Connor, Alexander Slocum
{"title":"A Novel Approach to Open Reduction and Internal Fixation of Distal Radius Fractures Utilizing a Multi-Degree-of-Freedom Traction and Stabilization Device.","authors":"Jacob F Oeding, Sam Bockman, Harriet Chiu, Cheyenne Hua, James Connor, Alexander Slocum","doi":"10.1115/1.4052901","DOIUrl":"https://doi.org/10.1115/1.4052901","url":null,"abstract":"<p><p>Open reduction and internal fixation (ORIF) is a surgical procedure performed with the objectives of restoring normal alignment and providing stability to broken bone fragments after a fracture. This procedure is increasingly used to treat fractures of the distal end of the radius. Reduction is achieved by the surgeon pulling and manipulating the hand while looking at real-time X-rays, and frequently requires large forces to distract impacted fragments from the proximal bone. This study presents the design and preliminary testing of a multi-degree-of-freedom (DOF) device capable of performing both distraction and reduction of fractured bone fragments using a traction splint mechanism with locking ball joints. A prototype was manufactured, and tests were conducted by a practicing hand surgeon. Both qualitative and quantitative tests using a phantom arm were performed. Quantitative force testing found an 80% reduction in the maximum force required to create needed traction, while qualitative tests with a hand surgeon found the device's ability to reduce and stabilize bone fragments while the hardware is secured to be more intuitive and less obstructive than existing techniques.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905091/pdf/med-21-1169_021006.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9555616","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}
Josh Leipheimer, Max Balter, Alvin Chen, Martin Yarmush
{"title":"Design and Evaluation of a Handheld Robotic Device for Peripheral Catheterization.","authors":"Josh Leipheimer, Max Balter, Alvin Chen, Martin Yarmush","doi":"10.1115/1.4053688","DOIUrl":"10.1115/1.4053688","url":null,"abstract":"<p><p>Medical robots provide enhanced dexterity, vision, and safety for a broad range of procedures. In this article, we present a handheld, robotic device capable of performing peripheral catheter insertions with high accuracy and repeatability. The device utilizes a combination of ultrasound imaging, miniaturized robotics, and machine learning to safely and efficiently introduce a catheter sheath into a peripheral blood vessel. Here, we present the mechanical design and experimental validation of the device, known as VeniBot. Additionally, we present results on our ultrasound deep learning algorithm for vessel segmentation, and performance on tissue-mimicking phantom models that simulate difficult peripheral catheter placement. Overall, the device achieved first-attempt success rates of 97 ± 4% for vessel punctures and 89 ± 7% for sheath cannulations on the tissue mimicking models (n = 240). The results from these studies demonstrate the viability of a handheld device for performing semi-automated peripheral catheterization. In the future, the use of this device has the potential to improve clinical workflow and reduce patient discomfort by assuring a safe and efficient procedure.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905093/pdf/med-21-1191_021015.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9926950","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}
Theodore Geoghegan, Kaustubh Patwardhan, Nicholas Nelson, Patrick Hill, Ryan Flynn, Blake Smith, Daniel Hyer
{"title":"Mechanical Characterization and Validation of the Dynamic Collimation System Prototype for Proton Radiotherapy.","authors":"Theodore Geoghegan, Kaustubh Patwardhan, Nicholas Nelson, Patrick Hill, Ryan Flynn, Blake Smith, Daniel Hyer","doi":"10.1115/1.4053722","DOIUrl":"https://doi.org/10.1115/1.4053722","url":null,"abstract":"<p><p>Radiation therapy is integral to cancer treatments for more than half of patients. Pencil beam scanning (PBS) proton therapy is the latest radiation therapy technology that uses a beam of protons that are magnetically steered and delivered to the tumor. One of the limiting factors of PBS accuracy is the beam cross-sectional size, similar to how a painter is only as accurate as the size of their brush allows. To address this, collimators can be used to shape the beam along the tumor edge to minimize the dose spread outside of the tumor. Under development is a dynamic collimation system (DCS) that uses two pairs of nickel trimmers that collimate the beam at the tumor periphery, limiting dose from spilling into healthy tissue. Herein, we establish the dosimetric and mechanical acceptance criteria for the DCS based on a functioning prototype and Monte Carlo methods, characterize the mechanical accuracy of the prototype, and validate that the acceptance criteria are met. From Monte Carlo simulations, we found that the trimmers must be positioned within ±0.5 mm and ±1.0 deg for the dose distributions to pass our gamma analysis. We characterized the trimmer positioners at jerk values up to 400 m/s<sup>3</sup> and validated their accuracy to 50 <i>μ</i>m. We measured and validated the rotational trimmer accuracy to ±0.5 deg with a FARO<sup>®</sup> ScanArm. Lastly, we calculated time penalties associated with the DCS and found that the additional time required to treat one field using the DCS varied from 25-52 s.</p>","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8905094/pdf/med-21-1157_021013.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9555615","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}
I. Mohedas, Carrie Bell, Betregiorgis Hailu Zegeye, KevinC Jiang, Caroline Soyars, Madeleine Walsh, K. Sienko
{"title":"Pre-Clinical Evaluation of a Task-Shifting Contraceptive Implant Insertion Device for Use in Low- and Middle-Income Countries","authors":"I. Mohedas, Carrie Bell, Betregiorgis Hailu Zegeye, KevinC Jiang, Caroline Soyars, Madeleine Walsh, K. Sienko","doi":"10.1115/1.4054684","DOIUrl":"https://doi.org/10.1115/1.4054684","url":null,"abstract":"\u0000 Worldwide, 225 million women have unmet contraceptive needs which, every year, leads to 52 million unintended pregnancies. A challenge to providing universal access to contraception is the large proportion of the population living in rural, difficult to access settings in low- and middle-income countries. The availability and delivery of effective contraception in rural areas is limited by the lack of trained healthcare providers. Barriers to the use of long-acting contraceptives in rural areas are more pronounced due to the advanced skill and training to administer. In this study, we describe the design and testing of the SubQ Assist, a task-shifting contraceptive implant insertion device that aims to reduce the training requirements for administering contraceptive implants while simultaneously ensuring safe and high quality administration. Cadaver testing in conjunction with ultrasound depth measurements were used to evaluate the efficacy of the SubQ Assist. Implant insertion between the SubQ Assist and a trained physician are compared. Cadaver testing and ultrasound depth measurements demonstrate that the SubQ Assist results in implant insertions that are statistically equivalent to implants inserted by a trained physician. Additionally, the results show that the lateral positioning of these implants would facilitate uncomplicated removal at a later date. These findings demonstrate proof of concept for the SubQ Assist and provide evidence for moving towards clinical testing. They demonstrate that the SubQ Assist may be an effective method of task-shifting the insertion of contraceptive implants to minimally trained providers in order to expand access in rural areas.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46920206","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}
Alizée Koszulinski, J. Sandoval, T. Vendeuvre, S. Zeghloul, M. Laribi
{"title":"Comanipulation Robotic Platform for Spine Surgery with Exteroceptive Visual Coupling: Development and Experimentation","authors":"Alizée Koszulinski, J. Sandoval, T. Vendeuvre, S. Zeghloul, M. Laribi","doi":"10.1115/1.4054550","DOIUrl":"https://doi.org/10.1115/1.4054550","url":null,"abstract":"\u0000 In this paper, a novel surgical robotic platform intended to assist surgeons in cervical spine surgery is presented. The purpose of this surgery is to treat cervical spine instabilities. The surgical procedure requires drilling into specific region of the vertebrae in order to attach spinal implants and ensure a normal spacing between each vertebra. In this context, the proposed robotic platform allows to control and restrict surgeon's movements to a specific drilling direction set by the surgeon. The current platform is composed of a collaborative robot with 7 DoF equipped with a drilling tool and directly comanipulated by the surgeon. A motion capture system, as an exteroceptive sensor device, provides the robot controller with the movement data of the vertebra to be drilled. Robot Operating System (ROS) framework is used to enable real-time communication between the collaborative robot and the visual exteroceptive device. In addition, an implemented compliance control program allows to enhance the safety aspect of the robotic platform. Indeed, the collaborative robot follow the patient's movements while constraining the tool movements to an optimal trajectory as well as a limited drilling depth selected by the surgeon. The robot's elbow movements are also restricted by exploiting the null-space in order to avoid collisions with other equipment or medical team members. Experimental drilling trials have been performed by an orthopedic surgeon to validate the usefulness and different functionalities of the developed robotic platform, and provide that a collaborative robot can comply with spine surgery procedure.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45983880","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}
Yazan M. Dweiri, Abdullah F. Al-Dwairi, Mousa Al-Zanina, Reham Al Diabat
{"title":"Elliptical Trainer Redesign to Diversify Muscles Recruitment","authors":"Yazan M. Dweiri, Abdullah F. Al-Dwairi, Mousa Al-Zanina, Reham Al Diabat","doi":"10.1115/1.4054548","DOIUrl":"https://doi.org/10.1115/1.4054548","url":null,"abstract":"\u0000 This work aims to introduce simple-to-implement modifications to the elliptical trainer device to increase its utility with added new exercise options. The effectiveness of the introduced modifications was assessed on 51 subjects, with effectiveness representing the recruitment of a broader range of muscle groups with desired intensity levels. The improvements include a new in-phase mode, where bilateral body synchronization creates a skiing-like motion, and a variable range of motion through adjusting the stride length of a rotating-link mechanism.\u0000 The impact of these modifications on muscle recruitment was assessed by recording surface electromyogram (sEMG) from eleven major muscles while performing a total of six exercise routines. The routines have various combinations of mode and intensity to cover the traditional mechanism and the newly- introduced mechanism adjustments for comparative analysis.\u0000 The results have shown that increasing the stride length increases the demand on lower limbs muscles during the anti-phase mode while decreasing it on upper limb muscles. When comparing the two exercise modes, all muscle groups showed significantly higher activity in the in-phase mode except for thigh muscles (Hamstrings and Quadriceps). Hamstrings revealed significantly higher activity in the anti-phase mode, while Quadriceps showed no significantly different activity between the two modes.\u0000 The introduced design modifications are shown to diversify the demand on major skeletal muscles hence improving its functionality at low added cost. Furthermore, these results can be exploited to implement gradual physiotherapeutic rehabilitation plans targeting various muscle groups with desired intensity levels.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44497712","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}
{"title":"High-Speed Jet Injector for Pharmaceutical Applications","authors":"Priyanka Hankare, Ashish Agrawala, V. Menezes","doi":"10.1115/1.4054549","DOIUrl":"https://doi.org/10.1115/1.4054549","url":null,"abstract":"\u0000 A shock wave-driven needle-free syringe was developed and tested for liquid jet delivery into an artificial skin model and porcine skin samples. The device could deliver an adequate volume of liquid to a depth sufficient for drug dissemination in skin samples. The device is equipped with a splash-proof conduit and a silencer for smooth operation. The concept is expected to minimize the pain of liquid injection by a) minimally breaching the blood vessels in the skin, b) reducing trauma, inflammation and aiding regeneration of the incised spot by the liquid of the jet, and c) preserving most of the micro-circulation system in the target, enabling an effective drug uptake. A theoretical model that predicts jet penetration into viscoelastic targets is derived and presented. A sound agreement has been observed between the experimental jet penetration depths and the corresponding theoretical predictions. The development can offer a cost-effective, minimally invasive health care solution for immunization and drug delivery.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43131626","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}
G. Villalba-Alumbreros, Carlos Moron-Alguacil, M. Fernández-Muñoz, I. Valiente-Blanco, E. Díez-Jiménez
{"title":"Scale Effects on Performance of BLDC Micromotors for Internal Biomedical Applications: a Finite Element Analysis","authors":"G. Villalba-Alumbreros, Carlos Moron-Alguacil, M. Fernández-Muñoz, I. Valiente-Blanco, E. Díez-Jiménez","doi":"10.1115/1.4054495","DOIUrl":"https://doi.org/10.1115/1.4054495","url":null,"abstract":"\u0000 This paper theoretically analyses the miniaturization effects on torque, efficiency and thermal behaviour of high torque permanent magnet BLDC motors with ferromagnetic core coils for internal medical devices. Using a finite element model of a 2-phase BLDC motor, scalability laws are provided for diameters between 0.1 and 100 mm and current densities between 1 and 1000 A/mm2. Based in the impact of the cogging torque and overheating of the motor, scale dependent operational limits are calculated. Operational threshold can be determined at the point where cogging torque becomes dominating over total torque, limiting the use of traditional iron-core motors in the micro-scale. To overcome such limitation, a potential solution is to increase the current density in the windings. However, overheating of the motor limits such increase in the current density which is critical for internal medical applications. Current density limits are provided based on three representative in-body thermal scenarios: respiratory tract, body fluid and blood torrent. Maximum current densities and corresponding torque and efficiency have been obtained for different micro-motor sizes considering safe in-body operation as threshold. It is demonstrated the potential application of micro-motors in internal body environments with acceptable performance for sizes down to 0.1 mm diameter.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42831496","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}
{"title":"Study On Device System to Reduce Tracheal Mucosal Injury in Intubation Patients","authors":"Dai Won Suh, Seung Bong Lee, Sung Min Kim","doi":"10.1115/1.4054334","DOIUrl":"https://doi.org/10.1115/1.4054334","url":null,"abstract":"\u0000 The purpose of this study was to develop an automatic bronchial aspiration system to minimize tracheal mucosal damage in ventilator patients. Operation performances of the system's suction pressure, bronchial intubation depth, suction cycle, and tube cuff pressure were tested. To check clinical results, subjects underwent endoscopy after applying the previous manual method for 24 hours. After that, they underwent endoscopy after applying the proposed suction system for 24 hours. For quantitative evaluation of test results, tracheal mucosal injury was divided into five grades: Grade 0 = normal, Grade 1 = erythema or edema, Grade 2 = erosion, Grade 3 = hemorrhage, and Grade 4 = ulcer or necrosis. In the performance test, an error of up to 12 mmHg occurred within the normal operation error range for suction pressure control. The insertion depth control had a maximum error of 7.0 mm within the normal operation error range. On the other hand, there was no error in the time control or the tube cuff pressure control. In the clinical trial, after using the proposed system for five subjects to find changes in tracheal mucosal injury by endoscopy, reduced injury or no change in injury was found. The system proposed in this study is confirmed to be able to remove sputum while minimizing tracheal mucosal injury that can occur when using previous manual suction device.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45704739","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}