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Publication Number
US-10506961-B1
Publication Date
2019-12-17
Expiration Date
Abstract
Devices and methods for assessing ulceration risk in a tissue. Some embodiments include a device having a scan head on an extension neck extending from housing and having range of motion relative to the housing. The scan head includes light-emitting system that alternately emits light at different selected wavelengths into the tissue, and a photodetector that generates an electrical signal based on the receive light. A processor calculates regional-perfusion-index (RPI) data based on the electrical signal. Some embodiments provide a tissue-vibration mechanism to help measure mechano-transduction induced recovery from vibratory stimulation for determining short-term metabolic deficit. In some embodiments, the scan head has a topological feature (such as one or more grooves, holes, bumps and/or ridges) that provides pressure-change stimulation for measuring vascular recovery from pressure changes. In some embodiments, the device includes accelerometers and/or pressure sensors to determine where the scan head is positioned relative to the patient's foot.
Core Innovation
The invention relates to a diagnostic device and method for assessing ulceration risk in a tissue of a patient by applying pressure from a scan head while a user holds a hand-held housing. The scan head is arranged with an extension neck such that both the extension neck and the scan head provide at least first and second ranges of motion.
Light is emitted at a selected wavelength of a predetermined set of wavelengths into the tissue, and reflected light is received by a photodetector to generate an electrical signal that is used for calculating regional-perfusion-index (RPI) data. The device includes a controller operatively coupled to a user interface and configured to control the light-emitting system and the photodetector, and a processor operatively coupled to the photodetector and the controller configured to calculate RPI data based at least in part on the electrical signal.
The invention further includes rolling the scan head in a medial and lateral direction across tissue while holding the hand-held housing, emitting the light at a first time, receiving reflected light, calculating RPI data, and displaying the RPI data via the user interface. The partial content also describes calculating oxygenated hemoglobin (oxy-Hb) and deoxygenated hemoglobin (deoxy-Hb) values based on intensity ratios and extinction coefficients.
Claims Coverage
The partial content provides three independent claims, each grounded in an RPI-based ulceration-risk assessment using a hand-held, position-adjustable scan head that emits light, detects reflected light, calculates RPI data, and displays the result. Across the independent claims, there are multiple inventive features related to mechanical positioning and pressure application, optical emission and detection architecture, RPI calculation, and medial/lateral scanning with user-interface display.
Hand-held pressure-applied rolling scan head with ranges of motion
A diagnostic device with a hand-held housing, an extension neck having at least a first range of motion relative to the hand-held housing, and a scan head having at least a second range of motion relative to the extension neck, arranged such that pressure is applied to the tissue from the scan head by a person holding the hand-held housing.
Multi-wavelength emission into tissue with reflected-light photodetection
A light-emitting system configured to emit light at a selected wavelength of a predetermined set of wavelengths at a first time and direct emitted light into the tissue, and a photodetector configured to receive light reflected from the tissue and generate an electrical signal based on received reflected light.
RPI calculation from photodetector electrical signal
A controller operatively coupled to the user interface and configured to control the light-emitting system and the photodetector, and a processor operatively coupled to the photodetector and the controller configured to calculate regional-perfusion-index (RPI) data based at least in part on the electrical signal.
Rolling scan across tissue with RPI calculation and display via user interface
A method that includes rolling the scan head in a medial and lateral direction across the tissue while holding the hand-held housing, emitting light at a selected wavelength at a first time, receiving reflected light and generating an electrical signal, calculating RPI data via the processor based at least in part on the electrical signal, and displaying the RPI data via the user interface.
Ulceration-risk assessment apparatus configured to press-and-roll scan head and display RPI data
An apparatus that includes a diagnostic device and means for pressing and rolling the scan head in a medial and lateral direction across the tissue while holding the hand-held housing, with pressure applied to the tissue from the scan head; means for emitting light at a selected wavelength at a first time; means for receiving reflected light and generating an electrical signal; means for controlling emitting and receiving; means for calculating RPI data based at least in part on the electrical signal; and means for displaying the RPI data.
Across the independent claims, ulceration risk is assessed by applying pressure using a hand-held, position-adjustable scan head that emits light at a selected wavelength into tissue, detects reflected light with a photodetector, and uses a processor to calculate regional-perfusion-index (RPI) data for display. The method claim additionally requires medial-and-lateral rolling across the tissue while holding the hand-held housing.
Stated Advantages
Documented Applications
No documented applications found
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