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

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 pO₂ 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 pO₂-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.

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.

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.