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Research Papers

Custom-Fit Three-Dimensional-Printed BiPAP Mask to Improve Compliance in Patients Requiring Long-Term Noninvasive Ventilatory Support

[+] Author and Article Information
Ying Ying Wu

Department of Mechanical Engineering,
Carnegie Mellon University,
5000 Forbes Avenue,
Pittsburgh, PA 15213
e-mail: yingyinw@alumni.cmu.edu

Deepshikha Acharya

Department of Biomedical Engineering,
Carnegie Mellon University,
5000 Forbes Avenue,
Pittsburgh, PA 15213
e-mail: dacharya@andrew.cmu.edu

Camilla Xu

Department of Mechanical Engineering,
Carnegie Mellon University,
5000 Forbes Avenue,
Pittsburgh, PA 15213
e-mail: qinx@andrew.cmu.edu

Boyle Cheng

Neuroscience Institute,
Allegheny General Hospital,
320 E North Avenue,
Pittsburgh, PA 15212
e-mail: bcheng@wpahs.org

Sandeep Rana

Department of Neurology,
Allegheny General Hospital,
320 E North Avenue,
Pittsburgh, PA 15212
e-mail: Sandeep.RANA@ahn.org

Kenji Shimada

Department of Mechanical Engineering,
Carnegie Mellon University,
5000 Forbes Avenue,
Pittsburgh, PA 15213
e-mail: shimada@cmu.edu

Manuscript received November 10, 2017; final manuscript received April 17, 2018; published online July 13, 2018. Assoc. Editor: Matthew R. Myers.

J. Med. Devices 12(3), 031003 (Jul 13, 2018) (8 pages) Paper No: MED-17-1346; doi: 10.1115/1.4040187 History: Received November 10, 2017; Revised April 17, 2018

Noninvasive ventilator support using bi-level positive airway pressure/continuous positive airway pressure (BiPAP/CPAP) is commonly utilized for chronic medical conditions like sleep apnea and neuromuscular disorders like amyotrophic lateral sclerosis (ALS) that lead to weakness of respiratory muscles. Generic masks come in standard sizes and are often perceived by patients as being uncomfortable, ill-fitting, and leaky. A significant number of patients are unable to tolerate the masks and eventually stop using their devices. The goal of this project is to develop custom-fit masks to increase comfort, decrease air leakage, and thereby improve patient compliance. A single-patient case study of a patient with variant ALS was performed to evaluate the custom-fit masks. His high nose bridge and overbite of lower jaw caused poor fit with generic masks, and he was noncompliant with his machine. Using desktop Stereolithography three-dimensional (3D) printing and magnetic resonance imaging (MRI) data, a generic mask was extended with a rigid interface such that it was complementary to the patient's unique facial contours. Patient or clinicians interactively select a desired mask shape using a newly developed computer program. Subsequently, a compliant silicone layer was applied to the rigid interface. Ten different custom-fit mask designs were made using computer-aided design software. Patient evaluated the comfort, extent of leakage, and satisfaction of each mask via a questionnaire. All custom-fit masks were rated higher than the standard mask except for two. Our results suggest that modifying generic masks with a 3D-printed custom-fit interface is a promising strategy to improve compliance with BiPAP/CPAP machines.

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References

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Figures

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Fig. 1

Schematic drawing of the modified custom-fit BiPAP mask

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Fig. 2

Interactive computer program: (a) custom 2D mask outline viewed perpendicular to the coronal plane and (b) the 3D computer-aided design model generated from the selected 2D mask outline

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Fig. 3

Photos of the interfacing side of the patient's previous mask, the original unmodified generic mask (mask 0) and ten modified custom-fit masks (masks 1–10)

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Fig. 4

Patient wearing one of the custom-fit masks

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