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Research Papers

J. Med. Devices. 2018;12(2):021001-021001-6. doi:10.1115/1.4039209.

Current techniques for diagnosing skin cancer lack specificity and sensitivity, resulting in unnecessary biopsies and missed diagnoses. Automating tissue palpation and morphology quantification will result in a repeatable, objective process. LesionAir is a low-cost skin cancer diagnostic tool that measures the full-field compliance of tissue by applying a vacuum force and measuring the precise deflection using structured light three-dimensional (3D) reconstruction. The technology was tested in a benchtop setting on phantom skin and in a small clinical study. LesionAir has been shown to measure deflection with a 0.085 mm root-mean-square (RMS) error and measured the stiffness of phantom tissue to within 20% of finite element analysis (FEA) predictions. After biopsy and analysis, a dermatopathologist confirmed the diagnosis of skin cancer in tissue that LesionAir identified as noticeably stiffer and the regions of this stiffer tissue aligned with the bounds of the lesion. A longitudinal, full-scale study is required to determine the clinical efficacy of the device. This technology shows initial promise as a low-cost tool that could rapidly identify and diagnose skin cancer.

Commentary by Dr. Valentin Fuster

Design Innovation Paper

J. Med. Devices. 2018;12(2):025001-025001-3. doi:10.1115/1.4039208.

Tube thoracostomy (TT) insertion can serve as a life-saving adjunct for thoracic trauma. Unfortunately, suboptimal positioning using the open, standard of care technique is associated with complications resulting in impaired TT function. Using a porcine model, we aimed to determine whether a magnetic chest tube positioning system (MCTPS) could be utilized to direct the intrathoracic TT position. Using recently deceased cross-bred domestic swine, we performed TT using our MCTPS and the standard of care open technique. The operator held one magnet outside of the thorax. The second magnet was positioned at the distal aspect of the TT. The operator was tasked with positioning the TT to distinct premarked intra-thoracic locations under blinded conditions. The experiment was video-recorded through an open sternotomy incision. As a control, TT was inserted using the standard of care open technique. The utilization of MCTPS successfully directed TT from one premarked location to another in 4 of 5 attempts (80%). Conversely, the control TT without magnetic guidance failed to navigate the premarked intra-thoracic locations with 0 of 5 attempts successful (p = 0.05). Positional flaws after TT placement are common. We demonstrate the feasibility of the MCTPS as an alternative to traditional hand-guided technique under simulated TT insertion conditions. The MCTPS is possibly superior to the current standard of care technique of TT. Additional studies are needed to develop this emerging technology in humans.

Commentary by Dr. Valentin Fuster

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