Apparatus and method for characterization of acute otitis media

Inventors

Moehring, Mark A.Gates, George A.Kreindler, Daniel M.Chesavage, Jay A.Singh, Rahul

Assignees

Otonexus Medical Technologies Inc

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Publication Number

US-11627935-B2

Patent

Publication Date

2023-04-18

Expiration Date


Abstract

An ultrasound signal processor uses an excitation generator to cause displacement of a tympanic membrane while a series of ultrasound pulses are applied to the tympanic membrane. Phase differences between a transmitted signal and received signal are examined to determine the movement of the tympanic membrane in response to the applied excitation. An examination of the phase response of the tympanic membrane provides a determination as to whether the fluid type behind the tympanic membrane is one of: no fluid, serum fluid, or purulent fluid.

Core Innovation

The invention provides an apparatus/signal processor and method for diagnosing acute otitis media by characterizing a tympanic membrane and the middle-ear effusion behind the tympanic membrane. It applies a pressure modulation to displace the tympanic membrane and transmits ultrasound acoustic waves toward the tympanic membrane, with reflected ultrasound waves received for phase-based analysis.

The system compares a phase of transmitted ultrasound to a phase of received reflected ultrasound and generates a phase output in response to the comparison. The phase output is compared to the excitation, and the temporal phase response relative to the excitation is used to estimate response characteristics of the tympanic membrane, including mobility.

The processor further uses the phase-output comparison, and optionally phase-related amplitude metrics, to estimate effusion or viscosity characteristics and to classify fluid type as no fluid, serous, or purulent. The described implementations include different ultrasound transmit/receive architectures and signal-processing options, including I/Q baseband mixing or direct RF sampling, along with handling of phase wrapping and unwrapping and pulse repetition frequency or time-of-flight considerations.

Claims Coverage

The provided content describes one independent method claim and dependent claims that refine it with specific excitation mechanisms, timing relationships, ultrasound transmission characteristics, and downstream determinations for response metrics and effusion or fluid categories. The independent claim contains four inventive features centered on pressure-modulated excitation, ultrasound transmit/receive with a micro-machined ultrasound transducer, phase comparison, phase output generation, and determining displacement or mobility of the tympanic membrane.

Pressure-modulated excitation of the tympanic membrane

Applying an excitation to the tympanic membrane to cause a displacement of the tympanic membrane, the excitation comprising a pressure modulation.

Ultrasound transmit/receive using a micro-machined ultrasound transducer

Transmitting with a micro-machined ultrasound transducer transmit acoustic waves toward the tympanic membrane during a transmit interval, and receiving reflected acoustic waves from the tympanic membrane during a receive interval.

Phase comparison and phase output generation

Comparing a phase of the transmitted transmit acoustic waves to a phase of the received reflected acoustic waves, generating a phase output in response to the comparison, and comparing the phase output to the excitation.

Determining displacement or mobility from phase-output comparison

Determining one or more of the displacement or a mobility of the tympanic membrane in response to the comparison of the phase output to the excitation.

The core coverage is the use of pressure modulation to displace the tympanic membrane, ultrasound transmission and reflection using a micro-machined ultrasound transducer, phase comparison to generate a phase output, and use of the comparison to the excitation to determine tympanic membrane displacement or mobility. Dependent claims add specific excitation frequency ranges, an air puff excitation, use of a capacitive micro-machined ultrasound transducer, constraints on pulse repetition rate, and classification of effusion categories using an effusion metric derived from phase output.

Stated Advantages

Enables determining displacement or mobility of the tympanic membrane based on a phase output compared to the excitation.

Enables characterizing middle-ear effusion by distinguishing fluid categories as no effusion, serum effusion, and purulent effusion using an effusion metric derived from phase output compared to the excitation.

Documented Applications

Diagnosing acute otitis media and characterizing middle-ear effusion behind the tympanic membrane by classifying fluid type as no fluid, serous, or purulent.

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