Apparatus and methods for compensation of blood volume effects on NIR spectroscopic measurements of blood analytes

• US 7,613,488 B1
• Filed: 12/22/2003
• Issued: 11/03/2009
• Est. Priority Date: 12/20/2002
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Niresults Incorporated
• Inventors: Farrelly, Darin L., Sterne, Chris, Kaushal, Ash, Li, Mang, Morand, Kenneth Anthony, Maracas, George N., Pawluczyk, Romuald, MacIntyre, Duncan, Bednarz, Bronislaw
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/745,234
• Time in Patent Office: 2,143 Days
• Field of Search: 600/310, 600/316, 600/335, 600/322
• US Class Current: 600/322
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/0055 by applying suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes

Abstract

The present invention provides a method for measuring a blood analyte concentration of a body part comprising removing a portion or all of the blood from the body part to produce a modified body part, and recording a first absorbance value of the modified body part. This is followed by filling the body part with blood to produce a filled body part, and recording a second absorbance value of the filled body part. A difference spectrum is obtained by subtracting the first absorbance values from the second absorbance values, and a calibration algorithm for the blood analyte is applied to the difference spectrum, thereby measuring the concentration of the blood analyte. Also provided is an apparatus for determining the concentration of a blood analyte of a body part. The apparatus comprising a chamber of a size and shape to receive the body part, where the chamber comprises an element for withdrawing and reintroducing blood from the body part, when the body part is inserted within the chamber. The chamber also comprising one or more than one port for introducing electromagnetic radiation into the chamber and onto that body part, and collecting remaining electromagnetic radiation following interaction with the body part.

Claims

1. A method for measuring a blood analyte concentration of a body part comprising:

a) removing a portion or all of the blood from said body part by rolling an elastic band along said body part, or by applying a positive pressure to said body part using a pressure/vacuum system, to produce a modified body part;

b) recording first absorbance values of said modified body part;

c) filling said modified body part with blood to produce a filled body part;

d) recording second absorbance values of said filled body part;

e) obtaining a difference spectrum by subtracting said first absorbance values from said second absorbance values; and

f) applying a calibration algorithm for said blood analyte to the difference spectrum to measure the concentration of said blood analyte.

2. The method of claim 1 wherein in said step of removing (step (a)), said modified body part is partially empty of blood.

3. The method of claim 1 wherein said body part is a finger.

4. The method of claim 1 wherein said blood analyte is selected from the group consisting of:

glucose, glycosylated hemoglobin, lactate, pyruvate, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, total protein, albumin, urea, creatinine, urate, sodium, potassium, chloride, bicarbonate, total hemoglobin, hematocrit, bilirubin, immunoglobulins, transferrin and ferritin.

5. The method of claim 1 wherein in said step of filling (step (c)), filling is performed by applying a negative pressure to said body part.

6. The method of claim 5 wherein said negative pressure is less than that required to rupture one or more than one blood vessel.

7. The method of claim 1 wherein in said step of filling (step (c)), filling is achieved by controlling the temperature of said body part.

8. The method of claim 1 wherein in said step of applying (step (f)), said calibration algorithm uses one or more wavelengths selected from the range of from about 650 nm to about 2800 nm.

9. The method of claim 1 wherein in said step of applying (step (f)), said calibration algorithm is developed using a chemometrics technique selected from the group consisting of:

simple linear regression, multiple regression or multivariate analysis.

10. The method of claim 1, wherein in said step of removing (step (a)), a portion or all of the blood from said body part is removed by rolling an elastic band along said body part.

11. An apparatus for measuring a blood analyte concentration of a body part, comprising:

i) a chamber of a size and shape to receive said body part, said chamber comprising an elastic band for withdrawing and reintroducing blood from said body part when said body part is inserted within the chamber,

ii) one, or more than one, port for introducing electromagnetic radiation into the chamber and onto said body part, and collecting remaining electromagnetic radiation following interaction with said body part, and

iii) a processor configured to determine a blood analyte concentration from a difference spectrum obtained by subtracting measurements obtained after at least a portion of the blood from said body part has been withdrawn, from measurements obtained after the blood has been reintroduced into said body part.

12. The apparatus of claim 11, wherein the chamber further comprises a seal at one end of the chamber, said seal of a size and shape for receiving said body part, and said seal defining an opening through which said body part may pass when said body part is inserted within said chamber.

13. The apparatus of claim 11 wherein said chamber is sized and shaped to fit a finger.

14. The apparatus of claim 11, wherein said chamber further comprises one or more than one first optical element for delivering electromagnetic radiation from a radiation source into said chamber through the one or more than one port, and one or more than one second optical element for collecting electromagnetic radiation following interaction with said body part.

15. A method for measuring a blood analyte concentration of a body part comprising:

a) removing a portion or all of the blood from said body part by rolling an elastic band along said body part, or by applying a positive pressure to said body part using a pressure/vacuum system, to produce a modified body part;

b) recording first reflectance values of said modified body part;

c) filling said modified body part with blood to produce a filled body part;

d) recording second reflectance values of said filled body part;

e) obtaining a difference spectrum by subtracting said first reflectance values from said second reflectance values, and

f) applying a calibration algorithm for said blood analyte to the difference spectrum to measure the concentration of said blood analyte.

16. The method of claim 15, wherein in said step of removing (step (a)), said modified body part is partially empty of blood.

17. The method of claim 15, wherein said body part is a finger.

18. The method of claim 15, wherein said blood analyte is selected from the group consisting of:

glucose, glycosylated hemoglobin, lactate, pyruvate, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, total protein, albumin, urea, creatinine, urate, sodium, potassium, chloride, bicarbonate, total hemoglobin, hematocrit, bilirubin, immunoglobulins, transferrin and ferritin.

19. The method of claim 15, wherein in said step of filling (step (c)), filling is performed by applying a negative pressure to the finger.

20. The method of claim 19, wherein said negative pressure is less than that required to rupture one or more than one blood vessel.

21. The method of claim 15, wherein in said step of filling (step (c)), filling is achieved by mechanical or pneumatic pressure.

22. The method of claim 21, wherein fullness of blood in said finger is maintained by application of a tight-fitting sheath or O-ring.

23. The method of claim 15, wherein in said step of filling (step (c)), filling is achieved by temperature control of said body part.

24. The method of claim 15, wherein in said step of applying (step (f), said calibration algorithm uses one or more wavelengths selected from the range of from about 650 nm to about 2800 nm.

25. The method of claim 15, wherein in said step of applying (step (f)), said calibration algorithm is developed using a chemometrics technique selected from the group consisting of:

simple linear regression, multiple regression or multivariate analysis.

26. The method of claim 15, wherein in said step of removing (step (a)), a portion or all of the blood from said body part is removed by rolling an elastic band along said body part.