Projects Previously Presented

82 BME SENIOR DESIGN PROJECTS

Improving Management, Detection, and Treatment of Iron-Deficiency Anemia With Rapid, Portable, and Affordable Next-Generation Point-of-Care Diagnostic Technology

Team 27: Andrew Chan, Parth Jalihal, Sahil Mohanty, Rohun Yarala Technical Advisors: Heather Fraser (Synthera Health), Javier Fernandez-Juarez (Synthera Health), Preeti

Putcha (Synthera Health)

Around five million people in the US currently suffer from iron deficiency anemia (IDA), but expensive and inconvenient standard blood testing options tend to lead to significantly late detection of this condition, thereby reducing the effectiveness of treatment options. The cost of repeating standard blood tests, which often process in several hours to days, can quickly become a great burden for patients in areas with relatively low health care resources who wish to test frequently. Potential lack of affordable transportation to well-equipped medical facilities also proposes an obstacle to consistent testing. Furthermore, even patients in developed, high cost-of-living areas with adequate medical resources are typically not tested enough to properly track and evaluate iron levels. Most standard blood tests also rely solely on hemoglobin sample detection to interrogate iron health status, ignoring other important markers which may also provide indicative medical information. To address these shortcomings, an affordable, novel, paper-based point of care (POC) diagnostic test for iron deficiency anemia will allow for rapid at-home testing for IDA. Utilization of multiple detection analytes and chemical paper mediums, which have colorimetric properties, will allow for more comprehensive analysis and can be operated with minimal sample preparation and knowledge by the user. Testing of iron biomarkers to evaluate iron health through this device will be repeatable at any desired frequency with little to no additional cost and provide results within mere minutes, offering a convenient and efficient solution to the existing IDA diagnostic barriers.

Characterization of A Subcutaneous Bleb Model

Team 29: Jordan Barker, Thomas Settelmayer Technical Advisor: Edward Tang (Takeda Pharmaceuticals)

Subcutaneous large volume infusions play a critical role in drug therapies that require continuous delivery at low dosages. Delivered into adipose tissue underneath the epidermis and dermis, subcutaneous injections provide many advantages over intravenous administration, including offering the possibility of at-home treatment, reducing user error and reducing overall care costs. Despite these advantages, subcutaneous administration of large volume infusions can lead to the formation of blebs that produce concentrated pressure, further leading to complications for patients receiving treatment. When utilizing subcutaneous injection volumes greater than 1 mL, these complications from bleb formation can include injection pain, high subcutaneous back pressure, leakage and reactions at the injection site. Current research on the formation of subcutaneous blebs is primarily performed through costly and laborious animal studies. Furthermore, these animal studies generally lack in providing sufficient quantitative data for analysis. To solve the issues associated with conventional animal studies, a three-part in-silico computer model was developed by Takeda Pharmaceuticals with the goal of assessing the contributing factors in predicting patient complications from bleb formations. The current computer modeling relies on the assumption that human subcutaneous tissue is a uniform space, which is not representative of real-world data and was unable to reproduce in vivo testing results. By conducting ex vivo studies utilizing proprietary subcutaneous modeling, we propose research guided solutions to flaws associated with Takeda’s current computer model. Results of the conducted ex vivo studies are ultimately leading to more robust in silico modeling, capable of providing a novel and efficient alternative to in vivo testing of large volume infusion therapies.

Implantable Microdevice for Drug Efficacy Testing in Tumors

Team 35: Samantha Downing, Rebecca Janes, Maria Merhej Technical Advisors: Oliver Jonas (BWH & Harvard Medical School), Kyle Deans (BWH), Sebastian Ahn

(BWH), Sharath Bhagavtula (BWH)

Implantable microdevices (IMDs) have emerged as a useful method to improve the processes of cancer treatment. Existing tumor imaging, tumor marking analysis, and other current alternative cancer drug assessment and treatment methods expose patients to drug toxicities, require months to years for results, and may not accurately model in vivo tumor sensitivities. Utilizing IMDs for assessment of brain and deep-tissue tumors requires modifications to the size and shape of existing IMD designs. Using clinician input, the brain IMD was redesigned for placement under the meninges and is removed with surrounding tissue through a biopsy procedure. Additional adjustments were made for removal by pulling on a nylon suture in the case of an aborted procedure. Force testing was performed to determine if the suture interface would be able to withstand estimated removal forces. The brain IMD was able to withstand a force over 120% greater than the force required as estimated by the clinician. The brain IMD was also able to withstand a force over 1200% greater than the force as estimated by phantom model testing. The deep-tissue IMD shaft design was significantly modified in order to facilitate minimally invasive retrieval through a 16-gauge needle. In order to evaluate drug effectiveness, a 400 μm radius of tissue is needed. The deep-tissue IMD design was tested in phantom gels and tissue samples in order to determine the amount of tissue collected during the biopsy. We plan to further investigate the efficacy of the brain and deep-tissue IMDs by conducting animal trials to evaluate their drug eluting properties.

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Delivery Device is inserted into the brain lesion site D Dosing Device releases drug microdoses into tumor Retrieval Frozen tumor sections are prepared for histology H Histological Analysis Determines drug effectiveness for comparisson

86 BME SENIOR DESIGN PROJECTS