# Pulsed Focused Ultrasound (pFUS) exposures and devices for tissue permeabilization without contrast agents

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2021 · $306,746

## Abstract

PROJECT SUMMARY
According to recent reports from across the world, the need to continuously evaluate lung edema in critically ill
COVID-19 patients is essential. Chest x-ray has reduced sensitivity early in the disease; the contagiousness of
the virus and the risk of transporting unstable patients with hypoxemia make chest CT a limited option for the
patient with suspected or established COVID-19. Lung ultrasound (LUS) is non-ionizing and safe, and has
recently emerged as a useful triage and monitoring tool for lung edema quantification in COVID-19 patients. In
LUS, imaging artifacts termed A-lines (periodic horizontal lines parallel to the lung surface indicating a normal
aeration pattern) and B-lines (comet-like hyperechoic regions indicating an alveolar or interstitial abnormality)
are evaluated. B-lines stem from acoustic reverberations within regions of alveolar edema, and their number and
thickness are known to be correlated with edema severity. However, visualization and quantification of B-lines
requires substantial training, and even then, are highly operator and machine dependent. This is in part due to
a still incomplete understanding of the exact physical mechanism of B-line formation. In this emergency
competitive revision to the current award on ultrasound cavitation-aided drug delivery to solid tumors we propose
to build on our expertise in dissecting the origins of US imaging artifacts and ultrasound instrumentation
capabilities to 1) identify the origins of B-line artifact in LUS and specific associated RF signal features, and 2)
based on the attained understanding, develop a single-element, wearable, automated, non-imaging lung
ultrasound sensor (LUSS) for continuous monitoring of lung pathology while minimizing provider time, risk of
virus exposure, and radiation. Individual adhesive LUSS elements will be attached to patients in specific
anatomic locations similarly to ECG leads, and ultrasound signals will be collected and processed with
automated algorithms to provide lung edema score that can be used in clinical decision making. We have
designed a proof of principle study scaled to the shortest timeline possible to get the device into the clinic quickly,
with the following specific aims. In SA1 we will perform standard LUS exams in non-COVID patients with
cardiogenic pulmonary edema while collecting raw RF signal data to understand the manifestation of B-lines in
raw RF signals and develop automated signal processing algorithm. In SA2 we will design and fabricate single-
element LUSS prototype and validate the automated signal processing algorithm against LUS imaging in lung-
mimicking sponge-based phantom. By the end of the 9-month project the prototype device will be ready for use
in not only COVID19 patients, but other ED patients for whom continuous evaluation of lung condition is essential
(bacterial pneumonia, cardiogenic edema, dialysis). Our commercialization approach here is to broadly license
this simple technology...

## Key facts

- **NIH application ID:** 10208594
- **Project number:** 3R01EB023910-04S1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Tatiana Khokhlova
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $306,746
- **Award type:** 3
- **Project period:** 2021-01-19 → 2021-09-18

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10208594

## Citation

> US National Institutes of Health, RePORTER application 10208594, Pulsed Focused Ultrasound (pFUS) exposures and devices for tissue permeabilization without contrast agents (3R01EB023910-04S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10208594. Licensed CC0.

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