Ambulatory clearance function monitor

• US 5,647,363 A
• Filed: 04/11/1994
• Issued: 07/15/1997
• Est. Priority Date: 11/18/1991
• Status: Expired due to Term

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Moore, Richard H., Rabito, Carlos A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/225,646
• Time in Patent Office: 1,191 Days
• Field of Search: 128/633, 128/653.1, 128/653.4, 128/653.3, 128/654, 128/659, 128/662, 128/664, 128/665, 356/39-41
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: G01T 1/161 Applications in the field of nuclear medicine, e.g. in vivo counting apparatus for radiation diagnosis A61B6/00

Abstract

Accurate and continuous monitoring of clearance function is obtained by determining the depletion of a labelled substance from the extracellular body fluid using an external monitor which detects from within the defined tissue volume. The detector of the external monitor is contained within a barrier which functions to both exclude external influences and to functionally isolate the volume of extracellular fluid to be monitored.

Claims

1. A device for measuring depletion of a detectable substance from a subject, comprising:

a detector having means for responding to a signal generated from a substance equilibrated within a subject'"'"'s extracellular fluid;

at least one barrier enclosing the detector and at least a portion of a body part of the subject, the barrier defining a constant volume of extracellular fluid within which the signal is detected, said at least one barrier adapted to prevent a signal external to the constant volume portion from reaching the detector; and

signal processing means for determining a clearance rate of the detectable substance, the signal processing means capable of measuring depletion of a quantity of said detectable substance within the defined constant volume of extracellular fluid.

2. The device of claim 1, wherein the signal processing means determines depletion of said detectable substance in said constant defined volume from a time change in quantity of said detectable substance within said constant volume of extracellular fluid.

3. The device of claim 2, wherein the signal processing means includes means to:

(i) obtain a first measure at a first time of the detectable substance in the defined constant volume of extracellular fluid;

(ii) obtain a second measure at a second time;

(ii) determine a slope of the first and second measures over a time interval; and

(iv) determine and express a clearance rate of said detectable substance using the slope of the first and second measures.

4. The device of claim 3, wherein said signal processing means determines and expresses a clearance rate within several minutes of said first measurement.

5. The device of claims 1 or 3, wherein said at least one barrier comprises a cuff that encloses at least a portion of the body part of the subject containing the defined tissue volume.

6. The device of claim 1, wherein said at least one barrier has defined therein an aperture for limiting signal from the subject to that signal capable of entering the aperture.

7. The device of claim 1, wherein said signal processing means includes a preamplifier.

8. The device of claim 7, wherein said signal processing means includes a discriminator.

9. The device of claim 1, wherein the signal processing means comprises a microcomputer and power supply in electrical communication with the signal processing means.

10. The device of claim 1, wherein the detector detects a signal from a radioactive label.

11. The device of claim 10, wherein the detector is a scintillation counter.

12. The device of claim 11, wherein the scintillation counter is a cadmium telluride or sodium iodide detector.

13. The device of claim 1, wherein the detector detects a signal from a fluorescent label.

14. The device of claim 13, wherein the fluorescent detector is a photodetector that includes a source of exciting radiation.

15. The device of claim 14, wherein the barrier encloses at least the portion of the body part that is substantially capable of transmitting light.

16. The device of claim 15, wherein the body part is an earlobe or fingertip.

17. The device of claim 1, wherein the detector detects a substance that ocurrs naturally within the subject.

18. The device of claim 17, wherein the detector detects creatine.

19. The device of claim 1, wherein the detector detects a substance that does not occur naturally within the subject.

20. The device of claim 19, wherein the detector detects benzene.

21. The device of claim 1, wherein said detector comprises a continuous, annular element enclosing at least the portion of the body part of the subject containing the defined tissue volume.

22. The device of claim 1, wherein the detector includes a plurality of detectors spaced apart from each other around at least the portion of the subject'"'"'s body part.

23. A portable device for measuring depletion of a detectable substance from a subject comprising:

a subject including a delectable substance;

a barrier having an elongated sheet capable of defining a volume of extracellular fluid when wrapped around an arm, the sheet having a width sufficient to encompass only a part of the arm and length sufficient to wrap around the arm, said barrier having a portion adapted to house a detector and a device for signal processing;

a detector dispersed within said portion for responding to a signal generated from a substance within the defined volume of extracellular fluid; and

a signal processing means dispersed within said portion for determining a clearance rate of the detectable substance by measuring depletion over time of a quantity of said detectable substance within the defined volume of extracellular fluid.

24. The device of claim 23, wherein the detectable substance emits radiation.

25. The device of claim 24, wherein said barrier comprises a material substantially opaque to detectable radiation.

26. The device of claim 25, wherein said barrier comprises lead.

27. The device of claim 23, wherein said barrier, detector and signal processing means are portable.

28. The device of claim 23, wherein said barrier has defined therein an opening adjacent to, and co-extensive with, a portion of the detector that is sensitive to the signal.

29. The device of claim 23, wherein said barrier comprises a sheet of vinyl lead and a sheet of radiotransparent material, the radiotransparent material providing a comfortable layer between the arm and the vinyl lead sheet.

30. The device of claim 29, wherein the radiotransparent material comprises plastic.

31. The device of claim 29, wherein the radiotransparent material comprises fabric.

32. A device for measuring renal clearance of a detectable substance from a subject, comprising:

a detector having means for responding to a signal generated from a substance equilibrated within a subject'"'"'s extracellular fluid;

at least one barrier enclosing the detector and at least a portion of a body part of subject body part, the barrier defining a constant volume of extracellular fluid within which the signal is detected, said at least one barrier adapted to prevent a signal external to the constant volume portion from reaching the detector; and

signal processing means for determining a renal clearance rate of the detectable substance, the signal processing means adapted to;

(i) obtain a first measurement of a quantity of said detectable substance at a first time, (ii) obtain a second measurement of a quantity of said detectable substance at a second time, (iii) determine a slope of the first and second measurements over a time interval and (iv) determine and express a clearance rate of said detectable substance using the slope of the first and second measurements within several minutes of said first measurement.

33. A device for measuring depletion of a detectable substance from a subject, comprising:

a detector responsive to a signal generated from a detectable substance equilibrated within a subject'"'"'s extracellular fluid;

at least one barrier enclosing the detector and at least a portion of a body part of the subject, the barrier defining a volume of extracellular fluid within which the signal is detected, said at least one barrier adapted to prevent a signal external to the volume portion from reaching the detector; and

signal processing means for determining a clearance rate of the detectable substance by measuring depletion of a quantity of said detectable substance within the defined volume of extracellular fluid further comprising a second detector responsive to a signal generated from a second detectable substance within the defined volume of extracellular fluid, wherein the signal froth the second detectable substance indicates a change in the defined volume of extracellular fluid.

35. The device of claim 33 or 34, wherein said detectable substance is a filtration marker used to monitor glomerular filtration rate and said another detectable substance is a non-clearing agent used to monitor a change in the defined volume of extracellular fluid.

34. A device for measuring depletion of a detectable substance from a subject, comprising:

a detector responsive to a signal generated from a detectable substance equilibrated within a subject'"'"'s extracellular fluid;

at least one barrier enclosing the detector and at least a portion of a body part of the subject, the barrier defining a volume of extracellular fluid within which the signal is detected, said at least one barrier adapted to prevent a signal external to the volume portion from reaching the detector; and

signal processing means for determining a clearance rate of the detectable substance by measuring depletion of a quantity of said detectable substance within the defined volume of extracellular fluid wherein said detector is responsive to multiple signals and further comprising a discriminator for resolving multiple signals, such that the signals generated by the detectable substance may be distinguished from a signal generated by another substance, wherein said signal by said another detectable substance indicates a change in the defined volume of extracellular fluid.

36. A method for measuring depletion of a detectable substance from a subject comprising:

providing a detectable substance to a subject, said detectable substance capable of equilibrating in a subject'"'"'s extracellular fluid;

allowing said detectable substance to equilibrate in the subject'"'"'s extracellular fluid;

wrapping a barrier around an upper arm portion of the subject, said upper arm portion defining a constant volume of the equilibrated extracellular fluid,

positioning a detector housed within the barrier on the upper arm portion of the subject;

allowing the detector to respond to a signal generated from the equilibrated substance within the defined constant volume;

measuring a response of said detector to the equilibrated substance, the response indicative of the quantity of said detectable substance within the defined constant volume of said equilibrated extracellular fluid; and

determining the depletion of said detectable substance from the measurement of a change in the quantity of said substance within the defined constant volume of said equilibrated extracellular fluid without withdrawing a fluid sample from the subject.

37. The method of claim 36, wherein the step of allowing said detectable substance to equilibrate comprises allowing equilibration for 15 to 20 minutes.

38. The method of claim 36, wherein the time interval between the step of measuring a response of said detector to said equilibrated substance and the step of determining the depletion of said substance is in the order of minutes.