METHODS AND SYSTEMS FOR DETECTING A CONDITION OF COMPARTMENT SYNDROME

• US 20100145169A1
• Filed: 11/30/2007
• Published: 06/10/2010
• Est. Priority Date: 12/01/2006
• Status: Abandoned Application

• Current Assignee: Hegln (Dalian) Pharmaceuticals, Inc.
• Original Assignee: Urodynamix Technologies Ltd.
• Inventors: Walls, Matthew Peter, Koay, Phaik, Zhu, Qichao, Li, Luya
• Application Number:
  US12/517,054
• Publication Number:
  US 20100145169A1
• Time in Patent Office: Days
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

Methods and systems for detecting and alerting one to a condition of Compartment Syndrome provide for determining concentration data of biochemical compounds in tissues, preferably at a shallow depth beneath the skin; analysing the concentration data to detect a condition of Compartment Syndrome; and triggering an alarm if a condition of Compartment Syndrome is detected. The concentration of biochemical compounds may be measured using Near Infrared Spectroscopy. The biochemical compounds may comprise at least one compound from the group consisting of Hemoglobin, Oxygenated Hemoglobin, Cytochromes and Myoglobin.

Claims

1. Apparatus for detecting a condition of a compartment syndrome, the apparatus comprising:

a non-invasive sensor positionable on a subject'"'"'s skin to detect a concentration of one or more biochemical compounds within the subject;

a trend analysis system coupled to measure a trend in the concentration of the one or more biochemical compounds; and

an alarm system connected to trigger an alarm signal in response to an output of the trend analysis system.

2. Apparatus according to claim 1 wherein the non-invasive sensor has a greatest sensitivity to detect the one or more biochemical compounds at a subcutaneous depth of 40 mm or less.

3. Apparatus according to claim 2 wherein the subcutaneous depth is in the range of 10 mm to 30 mm.

4. Apparatus according to claim 1 wherein the one or more biochemical compounds comprises a plurality of biochemical compounds and the trend analysis system determines trends in the concentrations of each of the plurality of biochemical compounds.

5. Apparatus according to claim 4 wherein the alarm system is configured to trigger the alarm signal based on the trends in concentrations of the plurality of biochemical compounds.

6. Apparatus according to claim 1 comprising a compartmental pressure estimator system for estimating inter-compartmental pressure based on the concentration of the one or more biochemical compounds.

7. Apparatus according to claim 6 wherein the alarm system is configured to trigger the alarm signal in response to the estimated inter-compartmental pressure exceeding an inter-compartmental pressure threshold.

10. Apparatus according to claim 6 wherein the alarm system is configured to trigger a first alarm signal if the estimated inter-compartmental pressure equals or exceeds a first inter-compartmental pressure threshold and to trigger a second alarm signal if the estimated inter-compartmental pressure equals or exceeds a second inter-compartmental pressure threshold.

11. Apparatus according to claim 1 wherein the non-invasive sensor comprises a near infrared spectrometry (NIRS) sensor.

12. Apparatus according to claim 11 wherein the NIRS sensor delivers near infrared (NIR) light in one or more bands in the wavelength range of 700 to 950 nm.

13. Apparatus according to claim 11 wherein the NIRS sensor comprises a NIRS light source and a NIR detector separated by a distance in the range of 30 to 60 mm.

14. Apparatus according to claim 13 wherein the distance is in the range of 40 to 60 mm.

15. Apparatus according to claim 1 wherein the non-invasive sensor is adapted to be held in place on a subject'"'"'s limb.

16. Apparatus according to claim 1 wherein the non-invasive sensor is adapted to be held in place on a subject'"'"'s abdomen.

17. Apparatus according to claim 1 wherein the trend analysis system comprises a differentiator configured to evaluate a first derivative of the concentration of the one or more biochemical compounds.

18. Apparatus according to claim 17 wherein the alarm system is configured to compare the first derivative to a predetermined first derivative threshold.

19. Apparatus according to claim 1 wherein the one or more biochemical compounds detected by the non-invasive sensor include one or more of hemoglobin (Hb), oxygenated hemoglobin (HbO2), a cytochrome (Cyt) and myoglobin (Mb).

20. Apparatus according to claim 19 wherein the apparatus comprises a processor configured to compute total hemoglobin concentration by summing concentrations of Hb and HbO2 measured by the non-invasive sensor and the trend analysis system monitors a trend of the total hemoglobin concentration.

21. Apparatus according to claim 20 wherein the alarm system is configured to trigger a total hemoglobin alarm if the total hemoglobin concentration exceeds a total hemoglobin threshold.

22. Apparatus according to claim 19 wherein the alarm system is configured to evaluate at least three of the following trigger conditions:

a) a first derivative of a concentration of HbO2 is less than or equal to a first threshold;

b) a first derivative of a sum of a concentration of Hb and the concentration of HbO2 is greater than or equal to a second threshold;

c) a first derivative of a concentration of Mb is greater than or equal to a third threshold;

d) a measured change in the sum of the concentration of Hb and the concentration of HbO2 is greater than or equal to a fourth threshold;

e) a measured change in the concentration of Mb is greater than or equal to a fifth threshold;

and the alarm system is configured to trigger the alarm system if any of the evaluated trigger conditions are satisfied.

23. Apparatus according to claim 22 wherein the apparatus is configured to evaluate four of the trigger conditions.

24. Apparatus according to claim 22 wherein the apparatus is configured to evaluate five of the trigger conditions.

25. Apparatus according to claim 19 wherein the trend analysis system is configured to determine a trend for a combination of at least two biochemical compounds selected from the group consisting of Hb, HbO2, Cyt and Mb.

26. Apparatus according to claim 19 wherein the alarm system is configured to trigger the alarm signal in response to a measured change in the concentration of Mb being greater than or equal to a predetermined Mb threshold.

27. Apparatus according to claim 19 wherein the alarm system is configured to trigger a first alarm signal if a first derivative of the concentration of HbO2 is less than a first threshold and to trigger a second alarm signal if the first derivative of the concentration of HbO2 is less than a second threshold that is more negative than the first threshold.

28. Apparatus according to claim 27 wherein the alarm system is configured to trigger a third alarm signal if a difference between initial values of the concentration of HbO2 is more negative than a third threshold and to trigger a fourth alarm signal if the difference between initial values of the concentration of HbO2 is more negative than a fourth threshold that is more negative than the third threshold.

29. Apparatus according to claim 19 wherein the alarm system is configured to trigger a first alarm signal if a difference between initial values of the concentration of HbO2 is more negative than a first threshold and to trigger a second alarm signal if the difference between initial values of the concentration of HbO2 is more negative than a second threshold that is more negative than the first threshold.

30. Apparatus according to claim 1 comprising a display wherein the apparatus is configured to display on the display a plot showing concentration of the one or more biochemical compounds as a function of time.

31. Apparatus according to claim 30 wherein the apparatus is configured to display on the display a total difference between initial and current values of the concentration of the one or more biochemical compounds.

32. Apparatus according to claim 30 wherein the apparatus is configured to display on the display a visual indication that the alarm system has triggered the alarm signal.

33. Apparatus according to claim 1 wherein the trend analysis system and alarm system comprise a programmed data processor.

38. Apparatus according to claim 33 wherein the inter-compartmental pressure estimator system is configured to estimate inter-compartmental pressure by extrapolation from an initial measured inter-compartmental pressure and initial values for the concentration of the one or more biochemical compounds in the subcutaneous region within the subject.

8. Apparatus according to claim wherein the compartmental pressure estimator system is configured to determine an estimated inter-compartmental pressure based at least in part on an initial measured inter-compartmental pressure and a difference between current and initial values of the concentration of the one or more biochemical compounds.

9. Apparatus according to claim 8 comprising a memory storing the initial measured inter-compartment pressure and an initial value of the concentration of the one or more biochemical compounds measured by the non-invasive sensor.

34. Apparatus for detecting a condition of a compartment syndrome, the apparatus comprising:

a non-invasive sensor positionable on a subject'"'"'s skin to detect a concentration of one or more biochemical compounds in a subcutaneous region within the subject;

an inter-compartmental pressure estimator system for estimating inter-compartmental pressure based on the concentration of the one or more biochemical compounds; and

,

an alarm system connected to trigger an alarm signal in response to an output of the inter-compartmental pressure estimator system.

35. Apparatus according to claim 34 wherein the noninvasive sensor comprises a near infrared spectrometry (NIRS) sensor.

36. Apparatus according to claim 35 wherein the NIRS sensor delivers near infrared (NIR) light in one or more bands in the wavelength range of 700 to 950 nm.

37. Apparatus according to claim 35 wherein the NIRS sensor comprises a NIRS light source and a NIR detector separated by a distance in the range of 30 to 60 mm.

39. A method for detecting a condition of compartment syndrome, the method comprising:

non-invasive monitoring a concentration of one or more biochemical compounds at a sub-cutaneous location within a subject; and

triggering an alarm based on at least one of;

a) a trend in the concentrations of at least one of the one or more biochemical compounds; and

,

b) comparison of the value of at least one of the one or more biochemical compounds to a threshold.

40. A method according to claim 39 comprising evaluating one or more of the following trigger conditions:

a) a first derivative of a concentration of HbO2 is less than or equal to a first threshold;

b) a first derivative of a sum of a concentration of Hb and the concentration of HbO2 is greater than or equal to a second threshold;

c) a first derivative of a concentration of Mb is greater than or equal to a third threshold;

d) a measured change in the sum of the concentration of Hb and the concentration of HbO2 is greater than or equal to a fourth threshold;

e) a measured change in the concentration of Mb is greater than or equal to a fifth threshold;

and triggering the alarm if any of the evaluated trigger conditions is satisfied.