KeyLoop retractor for global gasless laparoscopy: evaluation of safety and feasibility in a porcine model.

BACKGROUND: Many surgeons in low- and middle-income countries have described performing surgery using gasless (lift) laparoscopy due to inaccessibility of carbon dioxide and reliable electricity, but the safety and feasibility of the technique has not been well documented. We describe preclinical testing of the in vivo safety and utility of KeyLoop, a laparoscopic retractor system to enable gasless laparoscopy. METHODS: Experienced laparoscopic surgeons completed a series of four laparoscopic tasks in a porcine model: laparoscopic exposure, small bowel resection, intracorporeal suturing with knot tying, and cholecystectomy. For each participating surgeon, the four tasks were completed in a practice animal using KeyLoop. Surgeons then completed these tasks using standard-of-care (SOC) gas laparoscopy and KeyLoop in block randomized order to minimize learning curve effect. Vital signs, task completion time, blood loss and surgical complications were compared between SOC and KeyLoop using paired nonparametric tests. Surgeons completed a survey on use of KeyLoop compared to gas laparoscopy. Abdominal wall tissue was evaluated for injury by a blinded pathologist. RESULTS: Five surgeons performed 60 tasks in 15 pigs. There were no significant differences in times to complete the tasks between KeyLoop and SOC. For all tasks, there was a learning curve with task completion times related to learning the porcine model. There were no significant differences in blood loss, vital signs or surgical complications between KeyLoop and SOC. Eleven surgeons from the United States and Singapore felt that KeyLoop could be used to safely perform several common surgical procedures. No abdominal wall tissue injury was observed for either KeyLoop or SOC. CONCLUSIONS: Procedure times, blood loss, abdominal wall tissue injury and surgical complications were similar between KeyLoop and SOC gas laparoscopy for basic surgical procedures. This data supports KeyLoop as a useful tool to increase access to laparoscopy in low- and middle-income countries.

Design and Development of a Novel System for Remote Control of Stationary Oxygen Concentrator Flow Rate.

Purpose: Long-term oxygen therapy involves utilizing stationary oxygen concentrators to allow patients with respiratory illnesses to attain sufficient blood oxygenation via supplemental oxygen. Disadvantages of these devices include their lack of remote adjustability and domiciliary accessibility. To adjust oxygen flow, patients typically walk across their homes - a physically taxing activity - to manually rotate the knob of the concentrator flowmeter. The purpose of this investigation was to develop a control system device that allows patients to remotely adjust the oxygen flow rates on their stationary oxygen concentrator. Methods: The engineering design process was used to develop the novel FLO2 device. The two-part system is composed of 1) a smartphone application and 2) an adjustable concentrator attachment unit that mechanically interfaces with the stationary oxygen concentrator flowmeter. Results: Product testing indicates that users successfully communicated to the concentrator attachment from a maximum distance of 41m in an open field, suggesting usability from anywhere inside a standard home. The calibration algorithm adjusted oxygen flow rates with an accuracy of ±0.019 LPM and a precision of ±0.042 LPM. Conclusion: Initial design testing suggests the device as a reliable and accurate method of wirelessly adjusting oxygen flow on a stationary oxygen concentrator, but further testing should be performed on different stationary oxygen concentrator models.

Simulation device for shoulder reductions: overview of prototyping, testing, and design instructions.

BACKGROUND: Shoulder dislocations are common occurrences, yet there are few simulation devices to train medical personnel on how to reduce these dislocations. Reductions require a familiarity with the shoulder and a nuanced motion against strong muscle tension. The goal of this work is to describe the design of an easily replicated, low-cost simulator for training shoulder reductions. MATERIALS AND METHODS: An iterative, stepwise engineering design process was used to design and implement ReducTrain. A needs analysis with clinical experts led to the selection of the traction-countertraction and external rotation methods as educationally relevant techniques to include. A set of design requirements and acceptance criteria was established that considered durability, assembly time, and cost. An iterative prototyping development process was used to meet the acceptance criteria. Testing protocols for each design requirement are also presented. Step-by-step instructions are provided to allow the replication of ReducTrain from easily sourced materials, including plywood, resistance bands, dowels, and various fasteners, as well as a 3D-printed shoulder model, whose printable file is included at a link in the Additional file 1: Appendix. RESULTS: A description of the final model is given. The total cost for all materials for one ReducTrain model is under US $200, and it takes about 3 h and 20 min to assemble. Based on repetitive testing, the device should not see any noticeable changes in durability after 1000 uses but may exhibit some changes in resistance band strength after 2000 uses. DISCUSSION: The ReducTrain device fills a gap in emergency medicine and orthopedic simulation. Its wide variety of uses points to its utility in several instructional formats. With the rise of makerspaces and public workshops, the construction of the device can be easily completed. While the device has some limitations, its robust design allows for simple upkeep and a customizable training experience. CONCLUSION: A simplified anatomical design allows for the ReducTrain model to serve as a viable training device for shoulder reductions.

Low Cost Gastroschisis Silo for Sub-Saharan Africa: Testing in a Porcine Model.

BACKGROUND: Gastroschisis mortality in sub-Saharan Africa (SSA) remains high at 59-100%. Silo inaccessibility contributes to this disparity. Standard of care (SOC) silos cost $240, while median monthly incomes in SSA are < $200. Our multidisciplinary American and Ugandan team designed and bench-tested a low-cost (LC) silo that costs < $2 and is constructed from locally available materials. Here we describe in vivo LC silo testing. METHODS: A piglet gastroschisis model was achieved by eviscerating intestines through a midline incision. Eight piglets were randomized to LC or SOC silos. Bowel was placed into the LC or SOC silo, maintained for 1-h, and reduced. Procedure times for placement, intestinal reduction, and silo removal were recorded. Tissue injury of the abdominal wall and intestine was assessed. Bacterial and fungal growth on silos was also compared. RESULTS: There were no gross injuries to abdominal wall or intestine in either group or difference in minor bleeding. Times for silo application, bowel reduction, and silo removal between groups were not statistically or clinically different, indicating similar ease of use. Microbiologic analysis revealed growth on all samples, but density was below the standard peritoneal inoculum of 105 CFU/g for both silos. There was no significant difference in bacterial or fungal growth between LC and SOC silos. CONCLUSION: LC silos designed for manufacturing and clinical use in SSA demonstrated similar ease of use, absence of tissue injury, and acceptable microbiology profile, similar to SOC silos. The findings will allow our team to proceed with a pilot study in Uganda.

Learning Environments and Evidence-Based Practices in Bioengineering and Biomedical Engineering.

This paper provides a synopsis of discussions related to the Learning Environments track of the Fourth BME Education Summit held at Case Western Reserve University in Cleveland, Ohio in May 2019. This summit was organized by the Council of Chairs of Bioengineering and Biomedical Engineering, and participants included over 300 faculty members from 100+ accredited undergraduate programs. The Learning Environments track had six interactive workshops that provided facilitated discussion and provide recommendations in the areas of: (1) Authentic project/problem identification in clinical, industrial, and global settings, (2) Experiential problem/project-based learning within courses, (3) Experiential learning in co-curricular learning settings, (4) Team-based learning, (5) Teaching to reach a diverse classroom, and (6) innovative platforms and pedagogy. A summary of the findings, best practices and recommendations from each of the workshops is provided under separate headings below, and a list of resources is provided at the end of this paper.

Multidisciplinary Development of a Low-Cost Gastroschisis Silo for Use in Sub-Saharan Africa.

BACKGROUND: Gastroschisis silos are often unavailable in sub-Saharan Africa (SSA), contributing to high mortality. We describe a collaboration between engineers and surgeons in the United States and Uganda to develop a silo from locally available materials. METHODS: Design criteria included the following: < $5 cost, 5 ± 0.25 cm opening diameter, deformability of the opening construct, ≥ 500 mL volume, ≥ 30 N tensile strength, no statistical difference in the leakage rate between the low-cost silo and preformed silo, ease of manufacturing, and reusability. Pugh scoring matrices were used to assess designs. Materials considered included the following: urine collection bags, intravenous bags, or zipper storage bags for the silo and female condom rings or O-rings for the silo opening construct. Silos were assembled with clothing irons and sewn with thread. Colleagues in Uganda, Malawi, Tanzania, and Kenya investigated material cost and availability. RESULTS: Urine collection bags and female condom rings were chosen as the most accessible materials. Silos were estimated to cost < $1 in SSA. Silos yielded a diameter of 5.01 ± 0.11 cm and a volume of 675 ± 7 mL. The iron + sewn seal, sewn seal, and ironed seal on the silos yielded tensile strengths of 31.1 ± 5.3 N, 30.1 ± 2.9 N, and 14.7 ± 2.4 N, respectively, compared with the seal of the current standard-of-care silo of 41.8 ± 6.1 N. The low-cost silos had comparable leakage rates along the opening and along the seal with the spring-loaded preformed silo. The silos were easily constructed by biomedical engineering students within 15 min. All silos were able to be sterilized by submersion. CONCLUSIONS: A low-cost gastroschisis silo was constructed from materials locally available in SSA. Further in vivo and clinical studies are needed to determine if mortality can be improved with this design.

Fifty Years of Biomedical Engineering Undergraduate Education.

Undergraduate education in biomedical engineering (BME) and bioengineering (BioE) has been in place for more than 50 years. It has been important in shaping the field as a whole. The early undergraduate programs developed shortly after BME graduate programs, as universities sought to capitalize on the interest of students and the practical advantages of having BME departments that could control their own resources and curriculum. Unlike other engineering fields, BME did not rely initially on a market for graduates in industry, although BME graduates subsequently have found many opportunities. BME undergraduate programs exploded in the 2000s with funding from the Whitaker Foundation and resources from other agencies such as the National Institute of Biomedical Imaging and Bioengineering. The number of programs appears to be reaching a plateau, with 118 accredited programs in the United States at present. We show that there is a core of material that most undergraduates are expected to know, which is different from the knowledge base of other engineers not only in terms of biology, but in the breadth of engineering. We also review the role of important organizations and conferences in the growth of BME, special features of BME education, first placements of BME graduates, and a few challenges to address in the future.

Using a Teaching Intervention and Calibrated Peer Review™ Diagnostics to Improve Visual Communication Skills.

Rice University's bioengineering department incorporates written, oral, and visual communication instruction into its undergraduate curriculum to aid student learning and to prepare students to communicate their knowledge and discoveries precisely and persuasively. In a tissue culture lab course, we used a self- and peer-review tool called Calibrated Peer Review™ (CPR) to diagnose student learning gaps in visual communication skills on a poster assignment. We then designed an active learning intervention that required students to practice the visual communication skills that needed improvement and used CPR to measure the changes. After the intervention, we observed that students performed significantly better in their ability to develop high quality graphs and tables that represent experimental data. Based on these outcomes, we conclude that guided task practice, collaborative learning, and calibrated peer review can be used to improve engineering students' visual communication skills.

Maji: a new tool to prevent overhydration of children receiving intravenous fluid therapy in low-resource settings.

We designed and evaluated the accuracy and usability of a device to regulate the volume of fluid dispensed during intravenous drip therapy. The mechanical system was developed in response to a pressing need articulated by clinicians in pediatric wards throughout sub-Saharan Africa, who require a tool to prevent overhydration in children receiving intravenous fluid in settings that lack burettes or electronic infusion pumps. The device is compatible with most intravenous bags and limits the volume dispensed to a preset amount that can be adjusted in 50 mL increments. Laboratory accuracy over a range of clinically-relevant flow rates, initial bag volumes, and target volumes was within 12.0 mL of the target volume. The ease of use is "excellent," with a mean system usability score of 84.4 out of 100. Use of the device limits the volume of fluid dispensed during intravenous therapy and could potentially reduce the morbidity and mortality associated with overhydration in children receiving intravenous therapy.