SoftVueTM System - Delphinus Medical Technologies

Soft Vue

SoftVue™ is a true innovation and as the first of its kind, it introduces a new way of imaging the breast through the sophisticated capture and treatment of sound signals. Featuring proprietary TriAD™ (triple acoustic detection) technology, the system captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast. SoftVue™ has received FDA clearance for diagnostic imaging purposes and is not intended for use as a replacement for screening mammography.

The SoftVue Procedure

During the SoftVue™ procedure, the technologist assists the patient to lie prone with her breast suspended in a warm water reservoir. The Sequr™ Breast Interface is soft anatomically-formed gel guide that engages with the front of the breast in the warm water reservoir to center, shape and steady it during the imaging procedure.

A uniquely-designed comfort-pad and soft membrane layer are integrated with the table surface for patient comfort during the exam.

  • No breast compression is experienced by the patient
  • The system is designed to accommodate all breast sizes
  • The scan averages 2-4 minutes per breast
  • The membrane is flexible and pliant, contouring to the chest wall

Novel Ultrasound Tomography Design

By introducing a singularly unique approach in transducer design, SoftVue™ incorporates over 2000 transducer elements within a uniform ring configuration. Multi-parameter sound characteristics of reflection, sound speed, and attenuation are collected and retained in a circumferential, tomographic series analyzed by proprietary algorithms, providing volumetric measurements.

  • Each transducer element emits ultrasound signals in a sequenced 360° circular array surrounding the entire breast, scanning automatically from the nipple to the chest wall

system

  • Image acquisition is conducted in 2mm increments
  • TriAD™ technology captures not only reflection echoes that define anatomic detail, but also the transmission signals of sound speed and attenuation passing through the breast, that are measured
  • Three coronal cross-section image sets are presented of the entire breast, displayed in volumetric stacked format for interpretation and comparison with other breast imaging studies

Traditional hand-held ultrasound and automated breast ultrasound systems obtain only reflected echoes returning in the direction of the linear transducer. By contrast, SoftVue™ captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, something no other ultrasound system, currently available, can do.

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  • Sound speed and attenuation properties, deduced from signals transmitted through the breast, are essential in providing breast tissue characterization for evaluating tissue stiffness and density
  • Research has shown increased sound speed and attenuation to be associated with breast cancer.1 Greater breast density, a known factor for an increase in breast cancer risk, has shown to exhibit increased sound speed as well2

Ongoing research for future SoftVue™ applications includes evaluating the elastic properties of tumors and applying proprietary curved ray tomography to generate images based on through-transmission data. Our vision for SoftVue™ moves beyond anything that has been introduced before by combining the sound properties of reflection, speed, and attenuation.

 

1 Ranger, B., Littrup, P. J., Duric, N., Chandiwala-Mody, P., Li, C., Schmidt, S., &Lupinacci, J. (2012). Breast Ultrasound Tomography Versus MRI for Clinical Display of Anatomy and Tumor Rendering: Preliminary Results. American Journal of Roentgenology, 198(1), 233-239.

2 Duric, N., Boyd, N., Littrup, P., Sak, M., Myc, L., Li, C., …& Albrecht, T. (2013). Breast density measurements with ultrasound tomography: A comparison with film and digital mammography. Medical physics, 40, 013501.