Pneumoniacheck: a device for sampling lower airway aerosols
Scholz, Tamera Lee
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The pathogens causing pneumonia are difficult to identify because a high quality specimen from the lower lung is difficult to obtain. A specimen collection device, named the PneumoniaCheck, was previously designed to collect aerosol specimens selectively from the lower lung generated during deep coughing to aid in the diagnosis of specific pathogens causing pneumonia. The device also includes several specially designed features to exclude oral contaminants from the sample, and a filter to collect the aerosolized pathogens. The objective of this thesis is to develop tests to verify the functionality of the device, called the Design Inputs. Nine verification tests were performed to demonstrate the ability to collect lower airway aerosols separate from upper airway aerosols, successful exclusion of oral contents, and capture of pathogens in the filter. Further, the PneumoniaCheck was tested for proper sampling of the lower airway aerosols during deep cough at a very low volumetric flow rate to simulate patients with severe restrictive lung disease and with mal-positioning to simulate incorrect patient placement. Verification testing of the PneumoniaCheck demonstrates effective separation of upper airway gas from the lower airway gas (p<0.0001) and exclusion of both liquid and viscous oral material (p<0.0001) from the collection chamber. Testing also demonstrated the selective sampling of the lower airway, even during low volumetric flow rates or incorrect positioning of the device. The complex shape of the PneumoniaCheck presents a manufacturing challenge. Making the device from a solid and then drilling out the tubes would be difficult because the outer channels do not align with the inner channel. Rapid prototyping, vacuum molding, and injection molding are all manufacturing options. Rapid prototyping is slow, and usually only economic for small numbers of parts. For vacuum molding or injection molding, the PneumoniaCheck would need to be cut in half and molded, and then the halves connected with fasteners, glued, or welded. Vacuum molding is inexpensive, but there would be a lip at the connection that may be uncomfortable for patients. If the lip is on the inside of the device, it may interrupt air flow through the device. Injection molding is inexpensive and fast. The PneumoniaCheck could be injection molded in halves, and then glued or sonically welded together. Injection molding would be an efficient and economical way to manufacture the device. Verification tests were developed and performed, and the results demonstrate that the PneumoniaCheck successfully collects lower airway aerosols separate from upper airway aerosols, excludes oral contents, and captures pathogens in the filter, even during non-ideal conditions. After considering three different manufacturing options, injection molding was recommended for the device.