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Development and characterization of silicone-based tissue phantoms for pulse oximeter performance testing
Anant Bhusal1,2, Masoud Farahmand2, Md Sadique Hasan2
1University of Massachusetts, Department of Biomedical Engineering, Amherst, Massachusetts, United States.
Journal of Biomedical Optics
|January 8, 2025
Summary
Researchers developed silicone-based finger phantoms to test pulse oximeters, addressing accuracy disparities. These tissue-mimicking materials (TMMs) enable reliable bench-top performance assessment for more equitable medical devices.
Area of Science:
- Biomedical Engineering
- Optical Sensing
- Materials Science
Background:
- Pulse oximeters are critical for patient care but require human testing and show measurement disparities based on skin pigmentation.
- Developing reliable bench-top tests using tissue-simulating phantoms can improve pre-market assessment and device accuracy.
- Customized tissue-mimicking materials (TMMs) are essential for creating realistic phantoms that mimic physiological conditions.
Purpose of the Study:
- To develop and characterize novel silicone-based tissue-mimicking materials (TMMs) for creating realistic finger phantoms.
- To implement these phantoms in a pulsatile fluid network for pulse oximetry performance testing.
- To evaluate the TMMs' ability to mimic biological optical and mechanical properties and simulate variations in epidermal melanin content.
Main Methods:
- Formulated flexible silicone elastomers with varying components and curing protocols to achieve desired mechanical and optical properties.
- Developed channelized finger phantoms and integrated them into a pulsatile pressurized fluid network.
- Utilized optical coherence tomography (OCT) for channel diameter measurements and photoplethysmographic (PPG) sensors for optical signal acquisition.
Main Results:
- Optimized TMMs exhibited a Shore OO hardness of 32 and an elastic modulus of 130 kPa.
- Phantom channel diameter showed a linear pressure-dependent compliance, measured via OCT.
- The system generated tunable photoplethysmographic (PPG) modulation levels (0.6%–18.1% at 940 nm) and simulated variations in epidermal melanin content.
Conclusions:
- Established best practices for creating silicone-based tissue phantom tools for pulse oximetry performance testing.
- Demonstrated the potential of these phantoms for facilitating pre-market assessment of pulse oximeters.
- Highlighted the importance of TMM development for creating more accurate and equitable pulse oximetry devices.
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