Project Lead: Maggie Vuong
Project Members: Christal Chan, Darsh Jain, Saif Rjaibi, Hafsa Sohail, and Jenny Wei
Project Members: Christal Chan, Darsh Jain, Saif Rjaibi, Hafsa Sohail, and Jenny Wei
Summary
Cystic Fibrosis (CF) is a genetic disease that affects around 70,000 people around the globe. Individuals with CF are often challenged with respiratory and digestive system complications and are more prone to infection. Recent advancements in treatment and commercialized airway clearance devices have dramatically increased the quality of living and life expectancy of CF patients; however, there is a high cost of operating these devices over a patient’s lifetime, often rendering them financially inaccessible. The UT BIOME Device Team aims to develop an automated, airway clearing device for the treatment of patients with Cystic Fibrosis. After completing this project, the team will be looking into biomedical design competitions to share their work.
The Problem
Figure 1: Goblet Cell Anatomy [1]
Cystic Fibrosis is a genetically inherited disease characterized by the abnormal production of mucus by goblet cells (Figure 1) [1], leading to progressive damage to the respiratory and digestive systems. Normally, the mucus is thin and slippery but due to a defective gene caused by CF the secretions of the mucus become thick and sticky. The buildup of such mucus can clog airways, leading to damaged airways, chronic bacterial infections, pneumothorax, tissue scars, cysts formation, etc. Therapeutic advances in Cystic Fibrosis Treatment have increased life expectancy to 50-60 years, however these advancements impose a financial burden. With around 70,000 CF cases worldwide and approximately over 1000 new cases each year, it poses a need for technological advancements that considers the financial abilities of individuals to battle this disease. [2]
The lifestyle of cystic fibrosis patients is burdened by the need for constant medical attention and limited outdoor mobility. On average, patients depend on three oral and three inhaled medications daily, with multidisciplinary care team visits to 4 times or more in a year [3]. Additionally, the use of personal medical devices such as high-frequency chest wall oscillation allows the mitigation and evasion of mucus accumulation, but such devices can cost up to $15,000 to $20,000 CAD [4]. This financial burden presents a significant challenge for accessibility to such devices for low-economic areas.
The three main classes of airway clearance device for cystic fibrosis include: high-frequency chest compression (HFCC) devices, positive expiratory pressure (PEP) devices, and airway oscillating devices (AOD) [5]. HFCC vests are considered a standard of care for airway clearance devices [6]. The vest rapidly inflates and deflates to thin and loosen the mucus, allowing it to be coughed out. Patients are required to stay in close proximity while in use for about half an hour, twice a day. PEP devices help create airpaths which moves mucus from the lugs and airway wall through a mouthpiece. Similarly, AOD devices are handheld mechanical devices that creates vibrations in addition to PEP, further loosening the mucus [7]. These existing solutions are thoroughly researched by the Device Team to successfully design an accessible, affordable, and functional option to assist patients with CF.
The lifestyle of cystic fibrosis patients is burdened by the need for constant medical attention and limited outdoor mobility. On average, patients depend on three oral and three inhaled medications daily, with multidisciplinary care team visits to 4 times or more in a year [3]. Additionally, the use of personal medical devices such as high-frequency chest wall oscillation allows the mitigation and evasion of mucus accumulation, but such devices can cost up to $15,000 to $20,000 CAD [4]. This financial burden presents a significant challenge for accessibility to such devices for low-economic areas.
The three main classes of airway clearance device for cystic fibrosis include: high-frequency chest compression (HFCC) devices, positive expiratory pressure (PEP) devices, and airway oscillating devices (AOD) [5]. HFCC vests are considered a standard of care for airway clearance devices [6]. The vest rapidly inflates and deflates to thin and loosen the mucus, allowing it to be coughed out. Patients are required to stay in close proximity while in use for about half an hour, twice a day. PEP devices help create airpaths which moves mucus from the lugs and airway wall through a mouthpiece. Similarly, AOD devices are handheld mechanical devices that creates vibrations in addition to PEP, further loosening the mucus [7]. These existing solutions are thoroughly researched by the Device Team to successfully design an accessible, affordable, and functional option to assist patients with CF.
Our Solution
The UT BIOME Device Team aims to develop an automated, airway clearing device for the treatment of patients with Cystic Fibrosis. Particular attention will be devoted to incorporating ergonomic and user-friendly architecture and minimizing costs. Secondarily, the design will aim to determine the extent of mucus-induced airway obstruction and cater to individuals with other disabilities.
The primary function of the device will be to clear the airway of mucus - similar to current means of vibration and/or physiotherapy. It should also be able to do so automatically once prompted by the user. As current solutions can range in the thousands of dollars, the device aims to have a lower cost while still accomplishing the necessary functions. It will be focused on ergonomic and user-design, meaning it should operate with as little hindrance as possible and be intuitive enough to use by patients with little to no formal training. Additionally, a few "stretch goals" will be considered. Mucus quantification is the ability for the device to assess the extent of mucus accumulation and to sense when the airways have been sufficiently cleared. By taking device shape, size, and weight into consideration, the design aims to be more portable than existing solutions. Finally, the device interface and method of use will work towards accommodating patients who experience conditions or disabilities additional to CF. These stretch goals are not imperative to the design, but would enhance the proposed solution.
In order to achieve these goals, the project will be divided into three phases:
Phase 1 - Research aims to be completed by January 2021. This phase includes providing sufficient research, prototyping, and completing an initial conceptual design. The electrical and mechanical components will be assembled to produce a finalized conceptual design.
Phase 2 - Detailed Design will occur until February 2021. The design from Phase 1 will be iterated and modified to produce the detailed design.
Phase 3 - Systems and Verification/Validation will be completed by March 2021. Testing protocols will be finished, as well as Verification/Validation.
The primary function of the device will be to clear the airway of mucus - similar to current means of vibration and/or physiotherapy. It should also be able to do so automatically once prompted by the user. As current solutions can range in the thousands of dollars, the device aims to have a lower cost while still accomplishing the necessary functions. It will be focused on ergonomic and user-design, meaning it should operate with as little hindrance as possible and be intuitive enough to use by patients with little to no formal training. Additionally, a few "stretch goals" will be considered. Mucus quantification is the ability for the device to assess the extent of mucus accumulation and to sense when the airways have been sufficiently cleared. By taking device shape, size, and weight into consideration, the design aims to be more portable than existing solutions. Finally, the device interface and method of use will work towards accommodating patients who experience conditions or disabilities additional to CF. These stretch goals are not imperative to the design, but would enhance the proposed solution.
In order to achieve these goals, the project will be divided into three phases:
Phase 1 - Research aims to be completed by January 2021. This phase includes providing sufficient research, prototyping, and completing an initial conceptual design. The electrical and mechanical components will be assembled to produce a finalized conceptual design.
Phase 2 - Detailed Design will occur until February 2021. The design from Phase 1 will be iterated and modified to produce the detailed design.
Phase 3 - Systems and Verification/Validation will be completed by March 2021. Testing protocols will be finished, as well as Verification/Validation.
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References
[1] Katy McLaughlin, P. (2020, June 09). Goblet Cells. Retrieved September 29, 2020, from https://biologydictionary.net/goblet-cells/
[2] About Cystic Fibrosis. (n.d.). Retrieved September 16, 2020, from
https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/
[3] Preserving Access for People with CF: The Importance of Cost and Affordability. (n.d.). Retrieved September 16, 2020, from https://www.cff.org/About-Us/Our-Approach-to-Federal-State-and-Local-Policy/Policy-Spotlight/ Why-Cystic-Fibrosis-Treatments-and-Care-Need-to-Be-More-Affordable/
[4] L. Alma, “Airway Clearance Vest Systems for Cystic Fibrosis,” Verywell Health. [Online]. Available: https://www.verywellhealth.com/airway-clearance-vests-998326. [Accessed: 13-Sep-2020].
[5] “Airway Clearance Devices for Cystic Fibrosis An Evidence-Based Analysis,” Ontario Health Technology Assessment Series, Nov. 2009.
[6] I. M. MSc, “Airway Clearance Vests Fail to Show Measurable Lung Benefits in...,” Cystic Fibrosis News Today, 14-Aug-2018. [Online]. Available: https://cysticfibrosisnewstoday.com/2018/08/13/high-frequency-chest-wall-oscillation-vests-fail-t o-show-lung-function-benefits-using-standard-measures-in-study/. [Accessed: 13-Sep-2020].
[7] “High-Frequency Chest Wall Oscillation (the Vest),” CF Foundation. [Online]. Available: https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Airway-Clearance/High-Frequency- Chest-Wall-Oscillation. [Accessed: 13-Sep-2020].
[2] About Cystic Fibrosis. (n.d.). Retrieved September 16, 2020, from
https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/
[3] Preserving Access for People with CF: The Importance of Cost and Affordability. (n.d.). Retrieved September 16, 2020, from https://www.cff.org/About-Us/Our-Approach-to-Federal-State-and-Local-Policy/Policy-Spotlight/ Why-Cystic-Fibrosis-Treatments-and-Care-Need-to-Be-More-Affordable/
[4] L. Alma, “Airway Clearance Vest Systems for Cystic Fibrosis,” Verywell Health. [Online]. Available: https://www.verywellhealth.com/airway-clearance-vests-998326. [Accessed: 13-Sep-2020].
[5] “Airway Clearance Devices for Cystic Fibrosis An Evidence-Based Analysis,” Ontario Health Technology Assessment Series, Nov. 2009.
[6] I. M. MSc, “Airway Clearance Vests Fail to Show Measurable Lung Benefits in...,” Cystic Fibrosis News Today, 14-Aug-2018. [Online]. Available: https://cysticfibrosisnewstoday.com/2018/08/13/high-frequency-chest-wall-oscillation-vests-fail-t o-show-lung-function-benefits-using-standard-measures-in-study/. [Accessed: 13-Sep-2020].
[7] “High-Frequency Chest Wall Oscillation (the Vest),” CF Foundation. [Online]. Available: https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Airway-Clearance/High-Frequency- Chest-Wall-Oscillation. [Accessed: 13-Sep-2020].