Ultrasound Patch for Pedal Acceleration Time Detection
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Solution Overview
Problem
Current methods for diagnosing and managing peripheral arterial disease (PAD) and chronic limb-threatening ischemia (CLTI) are unreliable, especially in patients with calcified vessels, and lack real-time perfusion analysis, leading to challenges in surgical interventions and wound healing prediction.
Innovation Solution
An ultrasound device with a support structure and transducer assembly that facilitates positioning and orientation relative to the vasculature for measuring pedal acceleration time (PAT), providing a quantifiable and predictive indicator of perfusion in real-time, suitable for intraoperative guidance and postoperative surveillance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If optical technologies are used to evaluate perfusion, then microvasculature below skin surface can be detected, but vessels 1-2 cm below skin surface cannot be evaluated and reliability is reduced in severe small vessel disease
Solution Approach 1:
The patent replaces optical detection systems with ultrasound-based Doppler technology. The ultrasound transducer emits acoustic waves that penetrate deeper into tissue (1-2 cm) compared to optical methods, allowing detection of both superficial microvasculature and deeper arterial vessels. The Doppler effect measures blood flow velocity by detecting frequency shifts in reflected ultrasound waves, providing reliable perfusion assessment regardless of vessel depth or calcification status.
2Loss of information
If fluoroscopy with contrast is used for intraoperative imaging, then arterial visualization is achieved, but quantitative perfusion measurement is not possible and additional radiation exposure occurs
Solution Approach 1:
The patent replaces fluoroscopic imaging with ultrasound-based Doppler flow measurement. The ultrasound transducer continuously monitors blood flow velocity through the pedal arch vessels without requiring ionizing radiation or contrast agents. The system provides quantitative perfusion assessment by measuring Doppler waveforms and calculating flow parameters, eliminating both radiation exposure and the need for contrast media while maintaining real-time intraoperative monitoring capability.
3Reliability
If ABI or TBI tests are performed, then blood pressure comparison is achieved, but reliability is reduced when blood vessels are heavily calcified
Solution Approach 1:
The patent replaces pressure-based measurement (ABI/TBI using cuffs and sphygmomanometers) with ultrasound-based Doppler flow detection. The ultrasound transducer directly measures blood flow velocity waveforms in the pedal arch vessels, bypassing the need for pressure measurement in calcified arteries. This acoustic method remains reliable even when arterial walls are heavily calcified, as it detects flow dynamics rather than relying on pressure transmission through rigid vessels.
4Reliability
If multiple interventions are performed to improve perfusion, then blood flow to wound may be improved, but additional risks and time are incurred without knowing when to stop
Solution Approach 1:
The patent implements real-time intraoperative feedback by continuously monitoring Doppler waveforms and calculating the acceleration time (AT) parameter during surgical interventions. The system provides immediate quantitative assessment of perfusion changes, allowing the surgical team to observe the relationship between intervention intensity and perfusion improvement. By establishing objective perfusion thresholds correlated with wound healing outcomes, the system enables data-driven decision-making about when to continue or stop additional interventions, optimizing both patient outcomes and procedural efficiency.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables accurate and real-time assessment of perfusion in calcified vessels, guiding surgical interventions and predicting wound healing outcomes, thereby improving the management of PAD and CLTI.
Implementation Method 1
facilitates positioning and orientation of an ultrasound beam relative to the vasculature of the patient for the detection of Doppler signals from vessels
Implementation Method 2
an ultrasound transducer; and a coupling component for coupling ultrasound energy between the ultrasound transducer and the skin surface
Data Source
AI summary
Ultrasound systems and devices are provided that facilitate positioning and orientation of an ultrasound beam relative to the vasculature of the patient for the detection of Doppler signals from vessels and the determination of a hemodynamic measure. In some example embodiments, a support structure, such as a patch, is provided that supports one or more ultrasound transducers relative to a coupling component, the support structure being removably attachable to a skin surface of a subject. Control and processing circuitry is connectable to the one or more ultrasound transducers to generate ultrasound beams, receive ultrasound signals, and process the received ultrasound signals to provide a Doppler signal and determine an associated hemodynamic measure. In some example implementations, the example embodiments disclosed herein may be employed to determine a hemodynamic measure associated with blood flow with major and/or minor vessels of the pedal arch, such as a pedal acceleration time.


