Diagnostic transducer and method

• US 10,506,961 B1
• Filed: 03/09/2016
• Issued: 12/17/2019
• Est. Priority Date: 04/15/2015
• Status: Active Grant

• Current Assignee: Eden Medical, Inc.
• Original Assignee: Eden Medical, Inc.
• Inventors: Schoess, Jeffrey N.
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): Mustansir, Abid A
• Application Number:
  US15/065,810
• Time in Patent Office: 1,378 Days
• CPC Class Codes: A61B 5/0051 by applying vibrations
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/447 specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

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.

Claims

1. A diagnostic device for assessing ulceration risk in a tissue of a patient, the diagnostic device comprising:

a hand-held housing, wherein the hand-held housing includes a user interface;

an extension neck operatively coupled to the hand-held housing at a first end of the extension neck, wherein the extension neck has at least a first range of motion relative to the hand-held housing;

a scan head operatively coupled to the extension neck at a second end of the extension neck, wherein the scan head has at least a second range of motion relative to the extension neck, and wherein the hand-held housing, the extension neck, and the scan head are arranged such that pressure is applied to the tissue of the patient from the scan head by a person holding the hand-held housing, and wherein the scan head includes;

a light-emitting system configured to emit light at a selected wavelength of a predetermined set of wavelengths at a first time and to direct the emitted light into the tissue; and

a photodetector configured to receive light reflected from the tissue and generate an electrical signal based on the received reflected light;

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 and configured to calculate regional-perfusion-index (RPI) data based at least in part on the electrical signal generated by the photodetector.

2. The diagnostic device of claim 1, wherein the scan head includes an optical window, wherein the light-emitting system is configured to transmit the emitted light through the optical window and into the tissue, and wherein the photodetector is configured to receive the reflected light through the optical window.

3. The diagnostic device of claim 1, wherein the scan head further includes an optical window that is textured on its skin-facing surface, and wherein the processor is configured to determine the RPI data as the patient presses the optical window against the tissue and moves the scan head across the tissue to provide pressure differences to different portions of the tissue over time.

4. The diagnostic device of claim 1, wherein the scan head further includes an optical window that includes a transverse groove on an outer surface, and wherein the processor is configured to determine the RPI data as the patient presses the optical window against the tissue and moves the scan head across the tissue to provide pressure differences to different portions of the tissue over time.

5. The diagnostic device of claim 1, wherein the scan head further includes an optical window that includes a transverse ridge on an outer surface, and wherein the processor is configured to determine the RPI data as the patient presses the optical window against the tissue and moves the scan head across the tissue to provide pressure differences to different portions of the tissue over time.

6. The diagnostic device of claim 1, wherein the diagnostic device is battery powered.

7. The diagnostic device of claim 1, wherein the scan head includes a mechano-transduction vibration module configured to provide repetitive mechanical stress to the tissue.

8. The diagnostic device of claim 1, wherein the scan head includes an optical window, wherein the light-emitting system is configured to transmit the emitted light through the optical window and into the tissue, wherein the photodetector is configured to receive the reflected light through the optical window, wherein the optical window includes at least a first raised surface area, and wherein the optical window is configured to provide repetitive mechanical stress to the tissue.

9. The diagnostic device of claim 1, wherein the scan head includes a reflector panel configured to selectively control an amount of specular and diffuse light reflected to the photodetector.

10. The diagnostic device of claim 1, wherein the user interface includes an organic light-emitting diode (OLED) display configured to provide adjustable optical power, to display remaining battery life, and to display the RPI data.

11. A method for assessing ulceration risk in a tissue, the method comprising:

providing a diagnostic device, wherein the diagnostic device includes;

a hand-held housing, wherein the hand-held housing includes a user interface,

an extension neck operatively coupled to the hand-held housing at a first end of the extension neck, wherein the extension neck has at least a first range of motion relative to the hand-held housing,

a scan head operatively coupled to the extension neck at a second end of the extension neck, wherein the scan head has at least a second range of motion relative to the extension neck, wherein the scan head includes a light-emitting system and a photodetector, and wherein the hand-held housing, the extension neck, and the scan head are arranged such that pressure is applied to the tissue of the patient from the scan head by a person holding the hand-held housing,

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;

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 of a predetermined set of wavelengths from the light-emitting system at a first time and directing the emitted light into the tissue;

receiving light reflected from the tissue at the photodetector and generating an electrical signal based on the received reflected light;

calculating, via the processor, regional-perfusion-index (RPI) data based at least in part on the electrical signal; and

displaying the RPI data via the user interface.

12. The method of claim 11, wherein the scan head further includes an optical window that is textured, the method further including pressing the optical window against the tissue and moving the scan head across the tissue to provide pressure differences to different portions of the tissue over time.

13. The method of claim 11, wherein the scan head further includes an optical window that has a transverse groove on an outer surface, the method further including pressing the optical window against the tissue and moving the scan head across the tissue to provide pressure differences to different portions of the tissue over time.

14. The method of claim 11, wherein the displaying includes indicating a concentration of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in blood flowing through the tissue.

15. The method of claim 11, wherein the scan head further includes a vibration transducer on an outer surface, the method further including pressing the vibration transducer against the tissue and moving the scan head across the tissue to provide pressure differences to different portions of the tissue over time.

16. The method of claim 11, further comprising providing a repetitive mechanical stress to the tissue.

17. The method of claim 11, wherein the rolling includes rolling the scan head in a medial and lateral direction across chest tissue and rolling the scan head in a medial and lateral direction across foot tissue, wherein the RPI data includes an RPI value that is equivalent to a first oxygenated hemoglobin value of the chest tissue divided by a second oxygenated hemoglobin value of the foot tissue.

18. An apparatus for assessing ulceration risk in a tissue, the apparatus comprising:

a diagnostic device that includes a hand-held housing, a scan head, and means for pressing and rolling the scan head in a medial and lateral direction across the tissue while holding the hand-held housing, wherein the means for pressing and rolling the scan head has at least a first range of motion relative to the hand-held housing, wherein the scan head has at least a second range of motion relative to the means for pressing and rolling the scan head, and wherein the hand-held housing, the scan head, and the means for pressing and rolling the scan head are arranged such that pressure is applied to the tissue of the patient from the scan head by a person holding the hand-held housing;

means for emitting light from the scan head at a selected wavelength of a predetermined set of wavelengths from the light-emitting system at a first time and directing the emitted light into the tissue;

means for receiving light reflected from the tissue and for generating an electrical signal based on the received reflected light;

means for controlling the means for emitting light and the means for receiving light;

means for calculating regional-perfusion-index (RPI) data based at least in part on the electrical signal; and

means for displaying the RPI data.

19. The apparatus of claim 18, further comprising:

means, in the diagnostic device, for determining a first physiological state of the tissue by obtaining a first sequence of near-infrared (NIR) readings of the tissue during a first time interval while the subject is at rest;

means for combining spatial information from the first sequence of NIR readings to find an oxygenated hemoglobin concentration parameter and a deoxygenated hemoglobin concentration parameter and a light-absorption parameter to characterize the first physiological state;

means for applying a repetitive stress condition to the tissue for a second time interval;

means for removing the repetitive stress condition that was applied to the tissue;

means, in the diagnostic device, for determining a second physiological state of the tissue by obtaining a second sequence of NIR readings of the tissue during a third time interval while the subject is at rest;

means for combining spatial information from the second sequence of NIR readings to find an oxygenated hemoglobin concentration parameter and a deoxygenated hemoglobin concentration parameter and a light-absorption parameter to characterize the second physiological state;

means for comparing the first set of readings with the second set of NIR readings to determine a difference between the first and second physiological states of the tissue, wherein the oxyhemoglobin concentration in the arms and feet of ulcerated subjects is lower than oxyhemoglobin concentration in diabetics;

means for characterizing a pattern of ulceration susceptibility by a time-delay interval required to minimize the difference between the first and second physiological states, wherein the time-delay interval is a time period of perfusion recovery and/or the absolute difference in oxyhemoglobin concentration with the subject at rest with the lowest level of oxyhemoglobin concentration during recovery, wherein the risk of ulceration is determined by comparing the difference between the first and second physiological states of the subject at two different anatomical sites of the subject;

means for determining a ratio of oxyhemoglobin concentration at the two different anatomical sites to generate a first metric used to distinguish healthy tissue from tissue that is ulcerated or at risk of ulceration; and

means for determining a ratio of oxyhemoglobin concentration at the two different anatomical sites via an absolute difference in oxyhemoglobin concentration with the subject at rest with a lowest level of oxyhemoglobin during recovery to generate a second metric for distinguishing between healthy tissue from ulcerated tissue or tissue at risk of ulceration.

20. The apparatus of claim 18, wherein the scan head includes means for providing a repetitive mechanical stress to the tissue.