Abstract
Long-term, body-adhered medical devices rely on an adhesive interface to maintain contact with the patient. The greatest threat to on-body adhesion is mechanical stress imparted on the medical device. Several factors contribute to the ability of the device to withstand such stresses, such as the mechanical design, shape, and size of the device. This analysis investigates the impact that design changes to the device have on the stress and strain experienced by the system when acted on by a stressor. The analysis also identifies the design changes that are most effective at reducing the stress and strain. An explicit dynamic finite element analysis method was used to simulate several design iterations and a regression analysis was performed to quantify the relationship between design and resultant stress and strain. The shape, height, size, and taper of the medical device were modified, and the results indicate that, to reduce stress and strain in the system, the device should resemble a square in shape, be short in height, and small in size with a large taper. The square shape experienced 17.5% less stress compared to the next best performing shape. A 10% reduction in device height resulted in a 21% reduction in stress and 24% reduction in strain. A 20% reduction in device size caused a 7% reduction in stress and 2% reduction in strain. A 20% increase in device taper size led to a negligible reduction in stress and a 6% reduction in strain. The height of the device had the greatest impact on the resultant stress and strain.
Highlights
Long-term, body-adhered medical devices are products that are either not implanted or only partially implanted within a patient and adhered to the skin for a period of longer than 24 hours [1]
The maximum strain consistently occurs within the tissue substrate directly below the medical device
The stressor is moved over the device and it has clearly pressed the medical device downwards into the resilient tissue
Summary
Long-term, body-adhered medical devices are products that are either not implanted or only partially implanted within a patient and adhered to the skin for a period of longer than 24 hours [1] They can perform diagnostic or therapeutic tasks, such as biometric sensing and drug infusion. These devices rely on an adhesive patch or adhesive substrate to maintain attachment to the patient’s body (Figure 1). Since the adhesive material cannot be solely relied upon to increase reliability, other factors must be explored and optimized to ensure that the medical device remains on-body. The investigation uses an explicit dynamic finite element analysis (ANSYS v. 2020) to quantify the mechanical shear stress and shear strain experienced by a medical device system under defined conditions in a time-varying environment
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