A team of U.S. Army scientists working at the Institute of Surgical Research (USAISR) has recently developed a system for automated three and four-dimensional ultrasound quantification and surveillance of free fluid in body cavities and intravascular volume. The patented technology is available via patent license agreement to companies that would make, use, or sell it commercially.
In the trauma setting, free fluid is presumed to be abnormally present blood. The Focused Assessment with Sonography for Trauma (FAST) examination represents the current state of the art in free fluid sonographic detection. Trained technicians visually analyze two-dimensional (B-mode) images acquired in transverse and longitudinal planes in order to determine whether the fluid is present. FASTs primary limitations are that it must be performed and interpreted by an individual with advanced medical training, and it utilizes less accurate two-dimensional ultrasound.
In order to overcome those limitations, USAISR scientists have developed a three-dimensional ultrasound system with automated volume acquisition that is faster than two-dimensional ultrasound systems and requires minimal operator dependence, thus allowing for use by providers with no ultrasound experience.
The discovery automates FAST examinations and quantifies the volume of free fluid. It can quantify increasing fluid volume over time, allowing for interval change assessment for treatment optimization. The system provides detection, quantification, and monitoring of hemothorax, hemoperitoneum, subcapsular hematoma (e.g., liver, spleen, kidney), retroperitoneal hematoma, and/or automated volume status assessment and monitoring. For trauma resuscitation, the system is vascular targeting capable.
Providing automated three and four-dimensional ultrasound imaging (X-axis, Y-axis, Z-axis, and time) for hemorrhage detection and monitoring, the system can monitor the neck (e.g., internal Jugular vein, Carotid artery), abdomen (e.g., inferior vena cava) and/or groin (e.g., femoral vein and arteries). Examples of transducers that can be used in the system include a two-dimensional transducer used to sweep across an anatomic volume (region) of interest with the resulting sequential frames integrated into a three-dimensional volume data set representation; an automated transducer sweep acquisition of a three-dimensional volume; a recurrent automated sweep acquisition of the same volume to calculate changes over time (four-dimensional—i.e. dynamic or recurrent three-dimensional acquisitions); and/or numerous integrated sensors spread over space within a flexible material serving as a transducer, acquiring volumetric data sets, which are then further integrated via post-processing to create a larger volume set.
Vascular detection and identification of adjacent veins and arteries can be differentiated by wall thickness (arteries are thicker), wall collapsibility (veins compress more readily with pressure), Doppler direction of flow (arteries away from heart/veins toward heart), and/or Doppler waveform (distinct waveforms, velocities, and resistive indices). Anatomical atlas data are referenced to identify vessel and branch. This allows for the identification of vessels that have been disrupted or contain thrombus (no flow, altered flow).
Region of interest boundaries is determined by differences in echogenicity between fluid and more echogenic material such as organ parenchyma. While acute fluid collections tend to be hypoechoic, as blood products age and clot, collections may become complex. As a result, pre-programmed targeting of adjacent organs is offered to reduce the chance that a portion of an organ is inadvertently incorporated into a fluid region of interest.
- Automated volume detection allows for monitoring over time
- May be configured for use with various transducers
- Can be used in semi- or fully automated modes
- Allows for vascular detection and identification
- Can be constructed with or without a display
- Generates a 3D sonographic image
- Multiple scans of the same area allow for the calculation of an estimated rate of hemorrhage
- Businesses can commercialize the technology by licensing U.S. Patent App. 16/315,543 from the Army
- License fees paid to the Army are typically negotiable
- Businesses that license the technology may have access to the inventors
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