Problem Statement

BACKGROUND

Hyperbaric chambers are pressurized chambers, most often pressurized between 3 and 6 ATM, where patients breathe 100% oxygen or other prescribed gas mixtures. This therapy can help patients recover from chronic wounds, cancer radiation therapy, and other ailments. We will be focusing on emergency patients who need to be ventilated while treated in hyperbaric chambers.

Hyperbaric chambers currently use ventilators that are not equipped to operate optimally in highly pressurized environments [1]. To ensure the ventilators are outputting the desired volume, physicians and technicians use spirometers to measure the volume of air exhaled by the patient. For the National Fire Protection Association to allow a device in a hyperbaric chamber, it must run on fewer than 12 V and be able to withstand pressures up to 6 atm [2].

Mark 8 Wright's SpirometerImage via MedEx Supply

The current state of hyperbaric spirometers is the Mark 8 Wright's Spirometer. This spirometer is purely mechanical and requires manual reset after each breath which is incredibly inconvenient. It only measures the patient's tidal volume. It cannot record or save data. It can measure neither respiratory rate nor carbon dioxide concentrations which are measurements of respiratory output that physicians find useful. This bare minimum device should be replaced with a more competent device offering more ways to assess and track a patient's respiratory health.

Need Statement

A need has been identified for a hyperbaric-safe spirometer that automatically measures, displays, and records the tidal volume, respiration rate, and carbon dioxide concentration of ventilated patients.

MARKET ANALYSIS

Per year, approximately 3.15M USD is spent on ventilated hyperbaric oxygen therapy patients. Assuming each emergency capable hyperbaric oxygen clinic needs two spirometers, with 100% market share, the prevalence market value is 520,000 USD. A visual is included below.

Identifying the gap

References

[1] F. Burman, R. Sheffield, K. Posey, “Decision process to asses medical equipment for hyperbaric use,” Undersea and Hyperbaric Medical Society, 2009. [Online]. Available: https://www.uhms.org/images/Equipment-Articles/decision_process_to_assess_m.pdf [Accessed Oct. 11, 2019]

[2] “Hyperbaric Facilities,” National Fire Protection Association.

[3] Centers for Medicare and Medicaid services, "2017 Part B National Summary Data File Code Range: 05) Medicine (90000 - 99199, 99500 - 99999)", Centers for Medicare and Medicaid Services, 2017.

[4] Dr. Christopher Logue Interview

[5] M. McCafferty, "Alert Diver | Why Are Fewer Chambers Available for Emergencies?", Alertdiver.com, 2019. [Online]. Available: http://www.alertdiver.com/Fewer-Chambers-Available-for-Emergencies. [Accessed: 17- Oct- 2019].

[6]"Want a Cheap Spirometer? | Jones Medical", Jones Medical, 2019. [Online]. Available: https://www.jonesmedical.com/want-a-cheap-spirometer/. [Accessed: 17- Oct- 2019].

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