EndoPil: A Magnetically Actuated Swallowable Capsule for Weight Management: Development and Trials

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Annals of Biomedical Engineering (Ó 2020) https://doi.org/10.1007/s10439-020-02692-w

Original Article

EndoPil: A Magnetically Actuated Swallowable Capsule for Weight Management: Development and Trials PHUOC THIEN PHAN,1 ANTHONY MENG HUAT TIONG,1 MUNEAKI MIYASAKA,1 LIN CAO ,1 HUNG LENG KAAN,2 KHEK YU HO,3 and SOO JAY PHEE1 1

School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore; 2Department of General Surgery, National University Hospital, Singapore, Singapore; and 3Department of Medicine, National University of Singapore, Singapore, Singapore (Received 2 June 2020; accepted 11 November 2020) Associate Editor Jane Grande-Allen oversaw the review of this article.

Abstract—Intragastric balloons (IGBs), by occupying the stomach space and prolonging satiety, is a promising method to treat obesity and consequently improves its associated comorbidities, e.g. coronary heart disease, diabetes, and cancer. However, existing IGBs are often tethered with tubes for gas or liquid delivery or require endoscopic assistance for device delivery or removal, which are usually uncomfortable, costly, and may cause complications. This paper presents a novel tetherless, magnetically actuated capsule (EndoPil) which can deploy an IGB inside the stomach after being swallowed and being activated by an external magnet. The external magnet attracts a small magnet inside the EndoPil to open a valve, triggering the chemical reaction of citric acid and potassium bicarbonate to produce carbon dioxide gas, which inflates a biocompatible balloon (around 120 mL). A prototype, 13 mm in diameter and 35 mm in length, was developed. Simulations and bench-top tests were conducted to test the force capability of the magnetic actuation mechanism, the required force to activate the valve, and the repeatability of balloon inflation. Experiments on animal and human were successfully conducted to demonstrate the safety and feasibility of inflating a balloon inside the stomach by an external magnet. Keywords—Intragastric balloons, Obesity treatment, Ingestible capsule, Weight loss pill.

INTRODUCTION Obesity is a medical condition that happens when a person accumulates an excessive amount of body fat. This is a major risk factor for many comorbidities, Address correspondence to Lin Cao, School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore. Electronic mail: [email protected]

including hypertension, stroke, gallbladder and liver disease, cardiovascular morbidity and mortality, musculoskeletal disorders, type 2 diabetes mellitus, and certain types of cancer.6 The global prevalence of overweight and obesity is increasing rapidly. According to Non-communicable Disease Risk Factor Collaboration (NCD-RisC), the number of obese people nearly tripled during the period 1975–2016. In 2016, more than 2.3 billion people worldwide were overweight, and over 34% of this number were obese.1 A wide range of weight loss therapies, from lifestyle changing, to pharmacotherapy, to bariat