Microcavity-containing polymeric medical devices for enhanced ultrasonic echogenicity
Inventors
O'BRIEN-COON, DEVIN • Narrow, David
Assignees
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Publication Number
US-11858181-B2
Publication Date
2024-01-02
Expiration Date
Abstract
An ultrasound-detectable polymeric device that offers superior visibility of the body of the device and decreased ultrasound angle dependence through the use of microcavities and methods of manufacturing thereof is disclosed. These microcavities enable superior ultrasound visualization due to diffuse reflection of sound waves when compared to solid polymeric objects, ensuring that a strong signal is received at the source of the ultrasound transducer and providing strong image contrast throughout the entire cross-section of the implant that is also robust to variable angles of insonation.
Core Innovation
The invention relates to an ultrasound-detectable polymeric medical device containing dispersed microcavities configured to reflect ultrasonic signals. The microcavities are positioned within a second region of a polymer material that is continuously enveloped by a first region over an entirety of a surface area of the device. When the device is implanted in a patient, the microcavities reflect ultrasonic signals transmitted at one or more angles toward the device.
A central aspect is that the microcavities enhance B-mode visibility across the device volume using diffuse reflection and reduced dependence on insonation angle. The disclosure explains limitations of prior polymer ultrasound approaches, including edge-specular or surface-divot approaches for polymers, motivating a device in which microcavities act as ultrasound-reflecting structures distributed through the device volume.
The disclosed microcavity design enables echogenic performance described as maintaining contrast at ultrasound depths and providing stability after implantation conditions. The device includes a microcavity-containing region and an outer skin/barrier layer, and the document lists polymer material options that include resorbable and non-resorbable polymers.
Claims Coverage
The disclosed claims include one independent claim. The inventive features focus on an ultrasound-detectable implantable polymer device with a continuously enveloping first region and an internal microcavity-containing second region that reflects ultrasonic signals at one or more angles, with dependent claims further defining microcavity size, volume fraction, gas content, microcavity formation approach, and echogenic-marker behavior.
Ultrasound-detectable device with enveloping polymer regions and angle-reflecting microcavities
A polymer material including a first region and a second region, the first region continuously enveloping the second region over an entirety of a surface area of the device; and a plurality of microcavities dispersed within the second region and configured to reflect ultrasonic signals transmitted at one or more angles toward the device when the device is implanted in a patient.
Microcavity diameter range
At least one microcavity has a diameter between 0.1 and 950 microns.
Microcavities occupying 12% to 50% of total volume
The microcavities occupy between 12% and 50% of the device’s total volume.
Gas selection within microcavities
At least one gas selected from CO2 or N2.
Foaming with a blowing agent injected into the polymer material
The plurality of microcavities are formed by foaming a polymer material using a blowing agent injected into the polymer material.
Echogenic marker configured to receive and reflect ultrasonic signals
The ultrasound-detectable device is an echogenic marker that receives ultrasonic signals from an ultrasonic probe and reflects the signals back to the probe.
Overall, the claim coverage centers on a continuously enveloped polymer structure with a microcavity-containing second region in which dispersed microcavities are configured to reflect ultrasound at one or more insonation angles. Dependent refinements specify microcavity diameter, microcavity volume fraction, microcavity gas content, microcavity formation by foaming/blowing agent injection, and echogenic-marker receive/reflect behavior.
Stated Advantages
Enhances B-mode visibility across the device volume via diffuse reflection.
Reduces dependence on insonation angle.
Provides ultrasonic echogenic performance with multi-angle B-mode detection.
Maintains contrast at ultrasound depths of 1–5 cm.
Provides stability for ≥72 hours under dark/moist ~40°C conditions.
Documented Applications
Use as an ultrasound-detectable medical device that is implanted in a patient and imaged using B-mode ultrasound with multi-angle insonation.
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