| abstract |
A homogeneous, solid, elastic, biocompatible sheath which is conformal and performs as if integral to the diagnostic and/or therapeutic medical ultrasound transducer, and comprised of 20 to 95% biocompatible liquid, preferably about 70% to about 95% biocompatible liquid, that render properties to the sheath resulting in the desirable level of acoustic coupling, with acceptable low levels of acoustic artifacts, distortion and attenuation and provides a microbial barrier between the transducer and a surgical field or skin. Such sheaths are fabricated from a group of hydrophilic block co-polymers whose chemistry and physical properties provide ability to form products by dipping, casting, molding or extrusion. The device of this invention is a conformal ultrasound acoustic energy coupling and microbial barrier sheath that replaces gel or fluid ultrasound couplants and/or protective latex or synthetic elastomer covers, which require placement of ultrasound coupling fluids or gels between the cover and the transducer as well as between the cover and the body. The invention eliminates biological reactions from latex contact and harmful gel or fluid couplant spills into body orifices, organs, tissue and blood. The inventive sheath is sterilizable, replaceable, disposable, biocompatible, and leaves no harmful residue when used within the body orifices, intraoperatively, or during biopsy and aspiration, and remains lubricous when in contact with water based fluids. |