Design, Development and Pre-clinical Validation of a Novel Instrument to Faciltate Transcanal Endoscopic Ear Surgery

Transcanal (or totally) endoscopic ear surgery (TEES) is a minimally invasive ear surgical technique that has been shown to improve outcomes, reduce patient post-operative pain, recovery time, and hospital costs. The primary challenge with TEES is that it requires a one-handed surgical technique as the non-dominant hand controls the endoscope, which remains dynamic during surgery in order to visualize the surgical sites. In order to address the challenges surgeons experience while performing this type of surgery, this manuscript presents the motivation, design requirements, design, development and validation testing of a new instrument to facilitate this technique.Current TEES instruments are presented first to outline the design specifications for new instrumentation to be compatible with the TEES environment. The functional design requirements for a new instrument were motivated by a surgeon survey and a workflow study analysing instruments used during TEES. A new instrument that enables accessibility of anatomy visualized by the endoscope, dissection and removal of a benign skin tumor (cholesteatoma) as well as suction was called for. Next, the design process of developing a new instrument with intermittent surgeon feedback is presented. The feedback was obtained by testing the latest version of the prototype at conferences and surgical dissection courses over the course of the project. The feedback was used to design the final instrument that was shown to be able to do the following tasks in a TEES environment: (1) access more difficult to access anatomical structures than current tools in an anatomical validation study, using 3D printed temporal bone models; (2) dissect and remove an allograft (mockup cholesteatoma) from the middle ear space of a cadaveric goat model; and (3) enable suction within cadaveric goat and human models. Lastly, the final instrument prototype was shown to be able to (1) articulate to touch the boundary of the viewing angle of an endoscope; (2) enable suction at a similar rate as a currently used straight suction tool; and (3) safely withstand surgically relevant mechanical loading conditions expected during surgery via benchtop experiments.Ph.D

Using Role-Playing Simulations to Teach Quality Control in the Design of Medical Devices

A simulation is used to facilitate cooperative and team-based learning to introduce concepts of human factors, risk analysis, and quality control applied to the design of medical devices. We further use a friendly game-based approach to simulate the dynamics between a customer, a regulatory agency, and competitive manufacturers. Students are divided into manufacturing teams/companies and teaching assistants act as the customer and regulator. To promote positive interdependence and individual accountability, each student within a company is assigned roles of CEO, inspector, marketer, and designer. The goal for each company is to design and produce as many eye patch medical devices as possible, which must be approved by the regulator, within a tight deadline. Products are evaluated by the customer, who decides what price to pay for each unit, at the end of production. The most successful company is determined by the greatest amount of money earned after two rounds of production and sales.The authors gratefully acknowledge financial support from the Canadian Institutes of Health Research Operating Grants (CIHR MOP 142178) (VK), the AGE-WELL Network of Centres of Excellence in Technology and Aging Graduate Student Scholarships (VK), and Toronto Rehabilitation Institute Graduate Student Scholarships (VK). VK also gratefully acknowledges funding from the University of Toronto’s Institute of Biomaterials and Biomedical Engineering to present at CEEA 2017

Using a Multidisciplinary Team-Based Challenge to Promote Brainstorming and Prototyping of Medical Devices

Multidisciplinary teams of engineering and life science students are challenged to remove a foreign object from a child’s ear canal. Each group is provided with a model ear canal and asked to remove objects of different shapes and materials. The experience of iterative problem solving serves to encourage brainstorming and practice the prototyping process, which each team should complete in their over-arching design projects to be successful. Surveys taken from the students before and after the prototype challenge showed they learned more about the brainstorming method they used, but also learned what worked well for other groups. Student feedback indicates that this activity prepared them to be creative and tackle the larger challenge of developing a solution to their own design project as part of the Biomedical Engineering Capstone Design course.The authors gratefully acknowledge financial support from the Canadian Institutes of Health Research Operating Grants (CIHR MOP 142178) (VK), the AGE-WELL Network of Centres of Excellence in Technology and Aging Graduate Student Scholarships (VK), and Toronto Rehabilitation Institute Graduate Student Scholarships (VK). VK also gratefully acknowledges funding from the University of Toronto’s Institute of Biomaterials and Biomedical Engineering to present at CEEA 2017

Natural Gum-Based Functional Bioactive Films and Coatings: A Review

Edible films and coatings are a current and future food packaging trend. In the food and envi-ronmental sectors, there is a growing need to understand the role of edible packaging and sus-tainability. Gums are polysaccharides of natural origin that are frequently utilized as thickeners, clarifying agents, gelling agents, emulsifiers, and stabilizers in the food sector. Gums come in a variety of forms, including seed gums, mucilage gums, exudate gums, and so on. As a biodegradable and sustainable alternative to petrochemical-based film and coatings, gums could be a promising option. Natural plant gum-based edible packaging helps to ensure extension of shelf-life of fresh and processed foods while also reducing microbiological alteration and/or oxidation processes. In this review, the possible applications of gum-based polymers and their functional properties in development of edible films and coatings, were comprehensively dis-cussed. In the future, technology for developing natural gum-based edible films and coatings might be applied commercially to improve shelf life and preserve the quality of foods