Method for evaluating extracellular water concentration in tissue

• US 7,657,292 B2
• Filed: 11/18/2005
• Issued: 02/02/2010
• Est. Priority Date: 03/16/2001
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Nellcor Puritan Bennett LLC (Medtronic Plc)
• Inventors: Campbell, Shannon, Debreczeny, Martin, Schmitt, Joseph, Durr, Nick, Ostrowski, Rafeal, Hoarau, Carine, Baker, Clark R. Jr.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Berhanu; Etsub D
• Application Number:
  US11/283,506
• Publication Number:
  US 20070118027A1
• Time in Patent Office: 1,537 Days
• Field of Search: 600/309, 600/310, 600/407, 600/473, 600/476
• US Class Current: 600/310
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

The present disclosure provides systems, devices, and/or methods for assessing body fluid-related metrics and/or changes therein. The disclosure further provides systems, devices, and/or methods for correlating body fluid-related metrics in a particular tissue with the corresponding whole-body metric. The disclosure also provides, systems, devices, and/or methods for assessment of such metrics to facilitate diagnosis and/or therapeutic interventions related to maintaining and/or restoring body fluid balance.

Claims

1. A method for assessing an extracellular water metric in a subject, said method comprising:

using at least one sensor;

emitting light of at least one wavelength toward a tissue site of interest, wherein a portion of the emitted light is reflected by the tissue site of interest;

detecting at least one wavelength of the light reflected by the tissue site of interest from a position about one millimeter to about five millimeters from the tissue site of interest;

emitting light of at least one wavelength toward a reference tissue site, wherein a portion of the emitted light is reflected by the reference tissue site;

detecting at least one wavelength of the light reflected by the reference tissue site from a position about one millimeter to about five millimeters from the reference tissue site; and

using a processor;

processing detected reflected light from the tissue site of interest and detected reflected light from the reference tissue site to compute the extracellular water metric, wherein the hydrostatic pressure of the tissue site of interest differs from the hydrostatic pressure of the reference tissue site.

2. A method according to claim 1, wherein the extracellular water metric comprises intravascular water fraction, f_w^IV, interstitial water fraction f_w^IS, extracellular water fraction, f_w^EC, or water balance index, Q or combinations thereof.

3. A method according to claim 1, wherein the extracellular water metric comprises changes in the intravascular water fraction, Δ

f_w^IV, changes in the interstitial water fraction, Δ

f_W^IS, changes in the extracellular water fraction, Δ

f_W^EC, or changes in the water balance index, Δ

Q or combinations thereof.

4. A method according to claim 1, wherein the extracellular water metric is a metric of at least a portion of the subject'"'"'s whole body.

5. A method according to claim 4 further comprising comparing the extracellular water metric with a control and determining from that comparison whether the at least a portion of the subject'"'"'s whole body is dehydrated or over-hydrated.

6. A method according to claim 5 further comprising administering a hydration therapy to a dehydrated subject.

7. A method according to claim 5 further comprising administering a dehydration therapy to an over-hydrated subject.

8. A method according to claim 1 further comprising exhibiting the extracellular water metric on a display.

9. A method according to claim 1, wherein detecting at least one wavelength of the light reflected by the tissue site of interest comprises detecting light comprising a wavelength of 950-1400 nm, 1500-1800 nm, or 2000-2300 nm or any combination thereof.

10. A method according to claim 9 wherein the light comprises a wavelength of 1180 nm, 1125 nm, 1168 nm, 1170 nm, 1185 nm, 1190 nm, 1230 nm, 1245 nm, 1250 nm, 1274 nm, 1275 nm, 1300 nm, 1330 nm, 1710 nm, 1730 nm, or 1740 nm, or any combination thereof.

11. A method according to claim 9, wherein detecting at least one wavelength of the light reflected by the tissue site of interest comprises detecting at least two wavelengths of light with a first detector.

12. A method according to claim 11, wherein the wavelengths differ by at least 10 nm.

13. A method according to claim 9, wherein detecting at least one wavelength of the light reflected by the reference tissue site comprises detecting light comprising at least one wavelength within a wavelength band of 950-1400 nm, 1500-1800 nm, or 2000-2300 nm or any combination thereof.

14. A method according to claim 13, wherein the comprises a wavelength of 1180 nm, 1125 nm, 1168 nm, 1170 nm, 1185 nm, 1190 nm, 1230 nm, 1245 nm, 1250 nm, 1274 nm, 1275 nm, 1300 nm, 1330 nm, 1710 nm, 1730 nm, or 1740 nm, or combinations thereof.

15. A method according to claim 13, wherein detecting at least one wavelength of the light reflected by the reference tissue site comprises detecting at least two wavelengths of light with a second detector.

16. A method according to claim 15, wherein the wavelengths differ by at least 10 nm.

17. A method according to claim 1, wherein the emitting light of at least one wavelength toward the tissue site of interest comprises emitting light from a light source and wherein the emitting light of at least one wavelength toward the reference tissue site comprises emitting light from said light source.

18. A method according to claim 1, wherein the emitting light of at least one wavelength toward the tissue site of interest comprises emitting light from a first light source and wherein the emitting light of at least one wavelength toward the reference tissue site comprises emitting light from a second light source.

19. A method according to claim 1, wherein the detecting light of at least one wavelength reflected by the tissue site of interest comprises detecting light with a first detector and wherein the detecting light of at least one wavelength reflected by the reference tissue site comprises detecting light with a second detector.

20. A method according to claim 1, wherein the tissue site of interest and reference tissue site are located at two different sites within a single, contiguous organ.

21. A method according to claim 1, wherein the assessment is substantially independent of light scattering variations and temperature variations.

22. A method according to claim 1, wherein emitting light of at least one wavelength toward a tissue site of interest comprises emitting light with a light source about one millimeter to about five millimeters from the tissue site of interest.

23. A method according to claim 1, wherein emitting light of at least one wavelength toward a tissue site of interest comprises emitting light with a light source about one millimeter to about five millimeters from the reference tissue site.

24. A method according to claim 1, wherein the subject is a mammal.

25. A method according to claim 24, wherein the mammal is a human.

26. A method, for assessing an extracellular water metric in a subject, the method comprising:

using at least one sensor;

emitting light of at least one wavelength toward a tissue site of interest, wherein a portion of the emitted light is reflected by the tissue site of interest;

detecting at least one wavelength of the light reflected by the tissue site of interest from a position about one millimeter to about five millimeters from the tissue site of interest;

emitting light of at least one wavelength toward a reference tissue site, wherein a portion of the emitted light is reflected by the reference tissue site;

detecting at least one wavelength of the light reflected by the reference tissue site from a position about one millimeter to about five millimeters from the reference tissue site; and

using a processor;

processing detected reflected light from the tissue site of interest and detected reflected light from the reference tissue site to compute the extracellular water metric, wherein the detecting light of at least one wavelength reflected by the tissue site of interest comprises detecting light with a detector and wherein the detecting light of at least one wavelength reflected by the reference tissue site comprises detecting light with said detector.

27. A method, for assessing an extracellular water metric in a subject, the method comprising:

using at least one sensor;

emitting light of at least one wavelength toward a tissue site of interest, wherein a portion of the emitted light is reflected by the tissue site of interest;

detecting at least one wavelength of the light reflected by the tissue site of interest from a position about one millimeter to about five millimeters from the tissue site of interest;

emitting light of at least one wavelength toward a reference tissue site, wherein a portion of the emitted light is reflected by the reference tissue site;

detecting at least one wavelength of the light reflected by the reference tissue site from a position about one millimeter to about five millimeters from the reference tissue site; and

using a processor;

processing detected reflected light from the tissue site of interest and detected reflected light from the reference tissue site to compute the extracellular water metric, wherein the tissue site of interest and reference tissue site are located within different organs.

28. A method, for assessing an extracellular water metric in a subject, the method comprising:

using at least one sensor;

emitting light of at least one wavelength toward a tissue site of interest, wherein a portion of the emitted light is reflected by the tissue site of interest;

detecting at least one wavelength of the light reflected by the tissue site of interest from a position about one millimeter to about five millimeters from the tissue site of interest;

emitting light of at least one wavelength toward a reference tissue site, wherein a portion of the emitted light is reflected by the reference tissue site;

detecting at least one wavelength of the light reflected by the reference tissue site from a position about one millimeter to about five millimeters from the reference tissue site; and

using a processor;

processing detected reflected light from the tissue site of interest and detected reflected light from the reference tissue site to compute the extracellular water metric, wherein the tissue site of interest and reference tissue site are at substantially the same site under differing hydrostatic pressures, wherein the hydrostatic pressure of the tissue site of interest is altered to differ from the hydrostatic pressure of the reference tissue site.

29. A method, for assessing an extracellular water metric in a subject, the method comprising:

using at least one sensor;

emitting light of at least one wavelength toward a tissue site of interest, wherein a portion of the emitted light is reflected by the tissue site of interest;

detecting at least one wavelength of the light reflected by the tissue site of interest from a position about one millimeter to about five millimeters from the tissue site of interest;

emitting light of at least one wavelength toward a reference tissue site, wherein a portion of the emitted light is reflected by the reference tissue site;

detecting at least one wavelength of the light reflected by the reference tissue site from a position about one millimeter to about five millimeters from the reference tissue site; and

using a processor;

processing detected reflected light from the tissue site of interest and detected reflected light from the reference tissue site to compute the extracellular water metric;

and further comprising;

(a) excising from the subject the site of interest before the emitting;

(b) excising from the subject the reference site before the emitting, or

(c) excising from the subject both the site of interest and the reference site before the emitting.

30. A system for assessing an extracellular fluid metric in a subject, said system comprising:

a local fluid content probe configured to assess a local fluid content metric at a tissue site;

a location information sensor configured to assess location information of the probe, the tissue site of interest, or the probe and the tissue site of interest; and

a processor, wherein the processor is operably coupled to the local fluid content probe, operably coupled to the location information sensor, and configured to process a local fluid content metric and location information to produce an extracellular fluid metric.