Handheld Raman body fluid analyzer

• US 7,651,851 B2
• Filed: 01/27/2006
• Issued: 01/26/2010
• Est. Priority Date: 01/27/2005
• Status: Expired due to Fees

• Current Assignee: Prescient Medical, Inc.
• Original Assignee: Prescient Medical, Inc.
• Inventors: Clarke, Richard H., Womble, M. Edward
• Primary Examiner(s): Weber; Jon P
• Assistant Examiner(s): Shen; Bin
• Application Number:
  US11/340,712
• Publication Number:
  US 20060240401A1
• Time in Patent Office: 1,460 Days
• Field of Search: None
• US Class Current: 435/287.1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G01N 2021/656 Raman microprobe
• CPC Class Codes: G01N 21/65 Raman scattering
• CPC Class Codes: G01N 21/658 enhancement Raman, e.g. surface plasmons
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

Abstract

Methods and apparatus for in vitro detection of an analyte in a body fluid sample using low resolution Raman spectroscopy are disclosed. The body fluid analyzer includes a disposable strip for receiving a sample of body fluid on a target region, the target region including gold sol-gel to provide surface enhanced Raman scattering. A light source irradiates the target region to produce a Raman spectrum consisting of scattered electromagnetic radiation that is separated into different wavelength components by a dispersion element. A detection array detects at least some of the wavelength components of the scattered light and provides data to a processor for processing the data. The results of the processed data are displayed on a screen to inform a user about an analyte within the body fluid sample.

Claims

1. An apparatus for in vitro detection of an analyte in a body fluid sample using low resolution Raman spectroscopy with a resolution of between 10 cm⁻

1 and 100 cm<sup>−

1</sup> comprising;

a disposable strip for receiving a sample of body fluid on the target region;

a light source for irradiating the target region to produce a Raman spectrum consisting of scattered electromagnetic radiation;

a low resolution diffraction grating dispersion element positioned to receive and separate the scattered radiation into different wavelength components;

a detection array, optically aligned with the dispersion element for detecting at least some of the wavelength components of the scattered light; and

a processor for processing data from the detector array and calculating information about an analyte within the body fluid sample.

2. The apparatus of claim 1, wherein the processor calculates information about multiple analytes within the body fluid sample.

3. The apparatus of claim 2, wherein the multiple analytes further comprise at least one body fluid component.

4. The apparatus of claim 2, wherein the multiple analytes further comprise at least one drug.

5. The apparatus of claim 2, wherein the multiple analytes further comprise at least one disease marker.

6. The apparatus of claim 2, wherein the multiple analytes further comprise at least one poison.

7. The apparatus of claim 2, wherein the multiple analytes comprise at least two analytes related to a single preselected condition.

8. The apparatus of claim 7, wherein the single preselected condition is a single preselected health condition.

9. The apparatus of claim 2, wherein the multiple analytes comprise at least two analytes related to cardiac health.

10. The apparatus of claim 1, wherein the concentration of the analyte within the body fluid sample is calculated.

11. The apparatus of claim 1, wherein the disposable strip comprises a SERS-active material.

12. The apparatus of claim 11, wherein the disposable strip comprises a gold sol-gel strip to provide surface-enhanced Raman scattering.

13. The apparatus of claim 1, wherein the light source is a multi-mode laser.

14. The apparatus of claim 1, wherein the processor comprises a library of spectral properties of analytes for comparing with spectral information obtained from the body fluid sample.

15. The apparatus of claim 14, wherein the test strip target region comprises gold.

16. The apparatus of claim 14, wherein the test strip target region comprises a sol-gel.

17. The apparatus of claim 1, further comprising a screen for displaying information related to the analyte detected within the body fluid sample.

18. The apparatus of claim 17, wherein the at least one other analyte comprises hemoglobin Alc.

19. The apparatus of claim 1, wherein the analyte is selected from the group consisting of urea-based compounds, ammonium-based compounds, uric acid based compounds, nitrogen-based compounds, and combinations thereof.

20. The apparatus of claim 1, wherein the detected analyte in the body fluid sample is selected from the group consisting of cardiac enzymes, cardiovascular stent coatings, poisons, therapeutic drugs, drugs of abuse, hormones, steroids, and combinations thereof.

21. The apparatus of claim 1, further comprising a lancet to puncture a patient'"'"'s skin.

22. The apparatus of claim 1, wherein the analyte is a therapeutic drug.

23. The apparatus of claim 1, wherein the analyte is a metabolite of a therapeutic drug.

24. The apparatus of claim 2, wherein the multiple analytes comprise a therapeutic drug and one or more metabolites of the drug.

25. An apparatus for in vitro detection of an analyte in a body fluid sample using low resolution Raman spectroscopy with a resolution of between 10 cm⁻

1 and 100 cm<sup>−

1</sup> comprising;

a test strip for receiving a sample of body fluid on a target region, the target region comprising a metallic material to provide surface enhanced Raman scattering;

a laser for irradiating the target region to produce a Raman spectrum consisting of scattered electromagnetic radiation;

a low resolution diffraction grating dispersion element positioned to receive and separate the scattered radiation into different wavelength components;

a detection array, optically aligned with the dispersion element for detecting at least some of the wavelength components of the scattered light; and

a processor for processing data from the detector array and calculating glucose concentration and information about at least one other analyte within the body fluid sample.