Diagnosing peripheral vascular disease by monitoring oxygen saturation changes during a hyperemia phase

• US 7,582,060 B2
• Filed: 07/09/2008
• Issued: 09/01/2009
• Est. Priority Date: 05/05/2003
• Status: Active Grant

• Current Assignee: ViOptix, Inc.
• Original Assignee: ViOptix, Inc.
• Inventors: Mao, Jimmy Jian-min
• Primary Examiner(s): Nasser; Robert L
• Application Number:
  US12/170,305
• Publication Number:
  US 20080269574A1
• Time in Patent Office: 419 Days
• Field of Search: None
• US Class Current: 600/481
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06

Abstract

Peripheral vascular disease is diagnosed through measurements of oxygen saturation. In a specific implementation, peripheral vascular disease is diagnosed based on changes in oxygen saturation in tissue. Ischemia is induced, and then measurements of changes in oxygen saturation in tissue are made. Based on changes in oxygen saturation during a hyperemia phase, a diagnosis is provided of whether a patient has or does not have peripheral vascular disease.

Claims

1. A method of diagnosing peripheral vascular disease by causing a body part of a patient to experience occlusion, which comprises an ischemia phase, the method comprising:

measuring oxygen saturation in tissue of the patient during a hyperemia phase after the ischemia phase;

analyzing the oxygen saturation in the tissue during the hyperemia phase; and

diagnosing the patient as having peripheral vascular disease according to changes in the oxygen saturation in the tissue during the hyperemia phase.

2. The method of claim 1 comprising:

determining a midpoint of the hyperemia phase.

3. The method of claim 1 wherein the analyzing the oxygen saturation comprises calculating a rate of change of oxygen saturation during the hyperemia phase.

4. The method of claim 3 wherein the rate of change is calculated at approximately a midpoint of the hyperemia phase.

5. The method of claim 3 wherein the diagnosing the patient comprises determining if the rate of change crosses a threshold.

6. The method of claim 5 wherein the rate of change is calculated at approximately a midpoint of the hyperemia phase.

7. The method of claim 1 wherein the analyzing the oxygen saturation comprises calculating a time for oxygen saturation to reach a specified percentage during the hyperemia phase.

8. The method of claim 7 wherein the diagnosing the patient comprises determining if the time for oxygen saturation to reach a specified percentage crosses a threshold.

9. The method of claim 1 wherein the analyzing the oxygen saturation comprises:

calculating a rate of change of oxygen saturation during the hyperemia phase; and

calculating a time for oxygen saturation to reach a specified percentage during the hyperemia phase.

10. The method of claim 9 wherein the diagnosing the patient comprises determining if the rate of change and the time for oxygen saturation during the hyperemia phase cross thresholds.

11. The method of claim 1 comprising:

providing a visual indication of a positive or negative diagnosis of peripheral vascular disease on a display.

12. A method of diagnosing peripheral vascular disease by causing a body part of a patient to experience occlusion, which comprises an induced ischemia phase, the method comprising:

measuring oxygen saturation of the tissue of the patient during a hyperemia phase after inducing ischemia; and

diagnosing the patient as having peripheral vascular disease based on changes in the oxygen saturation of the tissue during the hyperemia phase after inducing ischemia.

13. The method of claim 12 comprising:

providing a visual indication of a positive diagnosis of peripheral vascular disease on a display when a measured rate of change in the oxygen saturation during the hyperemia phase crosses a threshold value.

14. The method of claim 12 comprising

providing a visual indication of a positive diagnosis of peripheral vascular disease on a display when a measured time for the oxygen saturation to crosses a percentage value during the hyperemia phase exceeds a specific time value.

15. The method of claim 12 comprising:

providing a visual indication of a positive diagnosis of peripheral vascular disease on a display when a measured time, from a starting time value to an ending time value, for the oxygen saturation to cross a percentage value exceeds a specific time value, wherein the ending time is within the hyperemia phase.

16. The method of claim 12 comprising:

providing a visual indication of a positive diagnosis of peripheral vascular disease on a display when a measured time, from a starting time value to an ending time value, for the oxygen saturation to cross a percentage value exceeds a specific time value, wherein the starting time is within the hyperemia phase.

17. A system for diagnosing peripheral vascular disease comprising:

a probe comprising a first detector input;

a computer, coupled to process signals received via the first detector input, to determine changes in oxygen saturation in tissue of a patient and make a diagnosis of peripheral vascular disease based on the oxygen saturation changes; and

a display, coupled to the computer, to provide a visual indication of a positive diagnosis of peripheral vascular disease,

wherein the diagnosis of peripheral vascular disease is positive when the computer determines a rate of change in the oxygen saturation crosses a threshold value during a hyperemia phase after induced ischemia.

18. A system for diagnosing peripheral vascular disease comprising:

a probe comprising a first detector input;

a computer, coupled to process signals received via the first detector input, to determine changes in oxygen saturation in tissue of a patient and make a diagnosis of peripheral vascular disease based on the oxygen saturation changes; and

a display, coupled to the computer, to provide a visual indication of a positive diagnosis of peripheral vascular disease,

wherein the diagnosis of peripheral vascular disease is positive when a measured time for the oxygen saturation to cross a percentage value during a hyperemia phase after induced ischemia exceeds a specific time value.

19. A system for diagnosing peripheral vascular disease comprising:

a probe comprising a first detector input;

a computer, coupled to process signals received via the first detector input, to determine changes in oxygen saturation in tissue of a patient and make a diagnosis of peripheral vascular disease based on the oxygen saturation changes; and

a display, coupled to the computer, to provide a visual indication of a positive diagnosis of peripheral vascular disease,

wherein the diagnosis of peripheral vascular disease is positive when a measured time, from a starting time value to an ending time value, for the oxygen saturation to cross a percentage value exceeds a specific time value, and the ending time is within a hyperemia phase after induced ischemia.

20. A system for diagnosing peripheral vascular disease comprising:

a probe comprising a first detector input;

a computer, coupled to process signals received via the first detector input, to determine changes in oxygen saturation in tissue of a patient and make a diagnosis of peripheral vascular disease based on the oxygen saturation changes; and

a display, coupled to the computer, to provide a visual indication of a positive diagnosis of peripheral vascular disease,

wherein the diagnosis of peripheral vascular disease is positive when a measured time, from a starting time value to an ending time value, for the oxygen saturation to cross a percentage value exceeds a specific time value, and the starting time is within a hyperemia phase after induced ischemia.

21. A system for diagnosing peripheral vascular disease comprising:

a probe comprising a first detector input;

a computer, coupled to process signals received via the first detector input, to determine changes in oxygen saturation in tissue of a patient;

a cuff, controllable by the computer and attachable to the patient, wherein the cuff causes a body part of the patient to experience occlusion, which includes an ischemia phase; and

a display, coupled to the computer, wherein the computer makes a diagnosis of peripheral vascular disease based on oxygen saturation changes in the tissue during a hyperemia phase after the ischemia phase, and the display provides a visual indication of a positive diagnosis of peripheral vascular disease.

22. The system of claim 21 wherein the probe comprises a second detector input and a source output, and a first distance between the first detector input and the source output is different from a second distance between the second detector input and the source output.

23. The system of claim 21 wherein the probe comprises a second detector input, a first source output, and a second source output, and a first distance between the first detector input and the first source output is different from a second distance between the second detector input and the second source output.

24. The system of claim 21 wherein the probe comprises a second detector input, a first source output, and a second source output, and a first distance between the first detector input and the first source output is substantially the same as a second distance between the second detector input and the second source output.