Vascular flow diagnostic system
Inventors
Assignees
Publication Number
US-11903688-B2
Publication Date
2024-02-20
Expiration Date
2038-10-01
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Abstract
A diagnostic system includes one or more blood flow sensors adapted to contact but not penetrate the skin of the pedal arch and aligned with blood vessels of the pedal arch. Readings from the blood flow sensors are transformed into blood flow acceleration times, and the blood flow acceleration times are used to identify a blood flow pathology.
Core Innovation
The invention relates to a diagnostic system that utilizes one or more blood flow sensors adapted to contact but not penetrate the skin of the pedal arch. The system measures blood flow acceleration times through these sensors aligned with blood vessels of the pedal arch, and uses the computed acceleration times to identify blood flow pathologies, providing an alternative diagnostic approach to conventional methods based on blood pressure measurements such as ankle-brachial indices (ABI) and toe-brachial indices (TBI).
The core problem addressed is the unreliability of current diagnostic techniques like ABI and TBI, particularly in patients with diabetes where such measurements often yield erroneous results. Peripheral arterial disease (PAD) leads to narrowing or occlusion of arteries in the legs, which reduces blood flow and can cause serious complications including amputation. Existing methods do not provide vascular specialists with reliable, real-time physiological data, especially during surgical interventions, to conclusively determine whether adequate blood flow has been restored to the foot.
Claims Coverage
The patent includes multiple independent claims focusing on a diagnostic system and methods for performing pedal Doppler ultrasound measurements using spatially arranged sensors aligned with pedal arch blood vessels.
Diagnostic system with multiple ultrasound sensors aligned with pedal arch vessels
A sensor mount incorporates a plurality of spatially separated ultrasound sensors that contact but do not penetrate the skin, each aligned with specific blood vessels of the pedal arch to measure ultrasound signals simultaneously from multiple vessels.
Control and processing circuitry for collective ultrasound signal analysis
The system includes control and processing circuitry that controls the emission and detection of ultrasound energy by the sensors and collectively analyzes the detected ultrasound signals from the multiple blood vessels to obtain a measure characterizing blood flow within the pedal arch at a given time.
Sensor mount configurations
The sensor mount can be configured as a pad, non-weightbearing surface, a pad placed on a technician's hand, or a glove wearable by a clinician to facilitate alignment of the sensors with the pedal arch vessels during measurement.
Method of using spatially arranged ultrasound sensors for pedal arch measurement
A method involving arranging and aligning multiple ultrasound sensors in a sensor mount with the pedal arch vessels, emitting ultrasound energy, detecting signals, obtaining readings from each sensor, and collaboratively analyzing these signals to characterize blood flow at the pedal arch.
The independent claims cover a diagnostic system and method using a spatially arranged array of ultrasound sensors that non-invasively contact the pedal arch to measure and collectively analyze blood flow signals from multiple vessels, with various sensor mount configurations to facilitate proper alignment and measurement.
Stated Advantages
Provides reliable, real-time physiological feedback on blood flow to the distal foot, especially useful during surgical procedures.
Offers an alternative diagnostic approach that is more accurate than conventional ankle-brachial and toe-brachial indices, particularly in diabetic patients where traditional methods often yield erroneous results.
Enables non-invasive measurement of blood flow acceleration times correlated with arterial occlusion, which helps predict areas with low arterial blood supply critical for wound healing and amputation prevention.
Allows for continuous monitoring with sensor arrays strategically positioned to align with key blood vessels, facilitating comprehensive vascular assessment.
Documented Applications
Diagnosing peripheral arterial disease (PAD) and critical limb ischemia by measuring blood flow acceleration times in the pedal arch arteries.
Providing real-time intraoperative monitoring of blood flow to the foot during vascular interventions to verify restoration of adequate perfusion.
Predicting wound healing capacity by identifying areas of low arterial blood supply via acceleration time measurements.
Use in non-invasive vascular diagnostics through sensor pads worn on the foot, technician’s hand, gloves, or non-weightbearing surfaces.
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