Handheld raman blood analyzer

• US 7,524,671 B2
• Filed: 01/27/2005
• Issued: 04/28/2009
• 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:
  US10/905,956
• Publication Number:
  US 20060166302A1
• Time in Patent Office: 1,552 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 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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

Abstract

Methods and apparatus for in vitro detection of an analyte in a blood sample using low resolution Raman spectroscopy are disclosed. The blood analyzer includes a disposable strip for receiving a sample of blood 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 a 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 blood sample.

Claims

1. An apparatus for in vitro detection of an analyte in a blood sample using low resolution Raman spectroscopy comprising:

a port sized and configured for receiving a test strip comprising a sample of blood on a target region of the test strip;

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 blood sample,

wherein the low resolution diffraction grating dispersion element provides the apparatus with a resolution in the range of 10 cm<sup>−

1</sup> to 100 cm<sup>−

1</sup>.

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

3. The apparatus of claim 2, wherein the multiple analytes further comprise at least one blood 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 1, wherein the concentration of the analyte within the blood sample is calculated.

8. The apparatus of claim 1, wherein the apparatus further comprises the test strip for delivery of the sample and wherein the test strip is disposable.

9. The apparatus of claim 8, wherein the disposable strip further comprises a gold sol-gel strip to provide surface enhanced Raman scattering.

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

11. The apparatus of claim 1, wherein the processor includes a library of spectral properties of analytes for comparing with spectral information obtained from the blood sample.

12. The apparatus of claim 1, including a screen for displaying information related to the analyte detected within the blood sample.

13. 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.

14. The apparatus of claim 1, wherein the detected analyte in the blood sample is selected from the group consisting of cardiac enzymes, cardiovascular stent coatings, poisons, prescription drugs, illicit drugs, hormones, steroids, and combinations thereof.

15. The apparatus of claim 1, including a lancet to puncture a patient'"'"'s skin.

17. The apparatus of claim 1, wherein the analyte is hemoglobin A1c.

18. The apparatus of claim 11, further comprising the test strip, wherein the target region of the test strip includes gold.

19. The apparatus of claim 11, further comprising the test strip wherein the target region of the test strip includes a sol-gel.

21. The apparatus of claim 1, wherein the port is sized and configured for insertion of the test strip in a longitudinal direction with respect to the longitudinal axis of the test strip.

22. The apparatus of claim 1, wherein the resolution is in the range of 30 cm⁻

1 to 50 cm<sup>−

1</sup>.

16. An apparatus for in vitro detection of an analyte in a blood sample using low resolution Raman spectroscopy comprising:

a strip for receiving a sample of blood on a target region, the target region including a 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 blood sample,

wherein the low resolution diffraction grating dispersion element provides the apparatus with a resolution in the range of 10 cm<sup>−

1</sup> to 100 cm<sup>−

1</sup>.

23. The apparatus of claim 16, wherein the resolution is in the range of 30 cm⁻

1 to 50 cm<sup>−

1</sup>.

20. A method for in vitro detection of an analyte in a blood sample using low resolution Raman spectroscopy comprising:

providing a disposable strip for receiving a sample of blood on a target region;

depositing a sample of blood on the target region of the disposable strip;

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

receiving and separating the scattered radiation into different wavelength components using a low resolution diffraction grating dispersion element providing a resolution in the range of 10 cm<sup>−

1</sup> to 100 cm<sup>−

1</sup>;

detecting at least some of the wavelength components of the scattered light using a detection array;

processing data from the detector array and calculating information about an analyte within the blood sample with a processor; and

displaying information related to the analyte detected within the blood sample on a screen.

24. The method of claim 20, wherein the resolution is in the range of 30 cm⁻

1 to 50 cm<sup>−

1</sup>.