Optical methods and systems for rapid screening of the cervix

• US 7,127,282 B2
• Filed: 04/12/2002
• Issued: 10/24/2006
• Est. Priority Date: 12/23/1998
• Status: Expired due to Fees

• Current Assignee: Luma Imaging Corp. (SpectraScience, Inc.)
• Original Assignee: MediSpectra, Inc. (SpectraScience, Inc.)
• Inventors: Nordstrom, Robert, Modell, Mark
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sullivan, Julianne M.
• Application Number:
  US10/122,429
• Publication Number:
  US 20020177777A1
• Time in Patent Office: 1,656 Days
• Field of Search: 600/317, 600473-478, 606/15, 356300-301, 356/318, 356450-451, 607/88, 607/94
• US Class Current: 600/477
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/4331 of the cervix A61B5/435 takes precedence

Abstract

A method and a system is provided for discriminating between healthy cervical tissue and pathologic cervical tissue based on the fluorescence response of the tissue to laser excitation (LIF) and the backscatter response to illumination by white light (in the spectral range of 360 to 750 nm). Combining LIF and white light responses, as well as evaluating a spatial correlation between proximate cervical tissue sites in conjunction with a statistically significant “distance” algorithm, such as the Mahalanobis distance between data sets, can improve the discrimination between normal and abnormal tissue. The results may be displayed in the form of a map of the cervix representing the suspected pathology.

Claims

1. A diagnostic system for optically classifying cervical tissue, the system comprising:

an optical illumination unit configured to provide UV light and broad spectrum light for illuminating a plurality of cervical tissue sites;

a detector configured to detect response signals at the tissue sites; and

a processor configured to classify the tissue by;

comparing the response signals with reference signals representative of cervical tissue of known pathology; and

comparing response signals from at least two proximate tissue sites, wherein the proximate tissue sites are spaced less than 2 mm apart along a surface of the cervical tissue.

2. The diagnostic system of claim 1, wherein the illuminated tissue sites are scanned in a predetermined pattern.

3. The diagnostic system of claim 1, further comprising at least one of a display and a printer for displaying a map of the classified cervical tissue sites.

4. The diagnostic system of claim 1, further comprising a memory for storing data.

5. The diagnostic system of claim 1, wherein the processor computes a Mahalanobis distance.

6. The diagnostic system of claim 1, wherein at least one of the optical illumination unit and the detector are spaced apart from the cervical tissue.

7. The diagnostic system of claim 1, wherein the tissue is classified as CIN (cervical intraepithelial neoplasia) tissue.

8. The diagnostic system of claim 1, wherein the UV light comprises light at a wavelength between 300 and 400 nm.

9. The diagnostic system of claim 8, wherein the UV light is produced by a laser.

10. The diagnostic system of claim 9, wherein the laser is a laser selected from the group consisting of a frequency-tripled Nd:

YAG laser, a nitrogen laser and a He-Cd laser.

11. The diagnostic system of claim 1, wherein the broad spectrum light comprises light at a wavelength in the visible spectral range.

12. The diagnostic system of claim 11, wherein the broad spectrum light is produced by a xenon lamp.

13. The diagnostic system of claim 1, wherein the response signals are normalized signals.

14. The diagnostic system of claim 1, wherein the reference signals are stored in a memory.

15. The diagnostic system of claim 1, wherein the response signals comprise a backscatter response, and wherein the backscatter response is calibrated against a target having a spectral reflectivity of approximately 10%.

16. The diagnostic system of claim 1, wherein the detector comprises a first system for detecting a UV light response and a second system for detecting a broad spectrum light response.

17. The diagnostic system of claim 1, wherein the tissue is classified as NED (normal squamous or no evidence of disease) tissue.

18. The diagnostic system of claim 1, wherein the optical illumination unit includes at least two light sources.

19. The diagnostic system of claim 1, wherein the UV light induces a fluorescence response and the broad spectrum light induces a backscatter response.

20. The diagnostic system of claim 19, wherein at least one of the fluorescence response and backscatter response is scaled with respect to the other of the backscatter response and fluorescence response.

21. The diagnostic system of claim 19, wherein the backscatter response is calibrated against a target having a known spectral reflectivity.

22. The diagnostic system of claim 1, wherein the processor is configured to compares response signals from at least two proximate tissue sites by employing a spatial discrimination algorithm.

23. The diagnostic system of claim 1, wherein illuminating the plurality of cervical tissue sites comprises illuminating the cervical tissue sites sequentially with UV light and with broad spectrum light.

24. The diagnostic system of claim 1, wherein illuminating the pluarlity of cervical tissue sites comprises illuminating the cervical tissue sites simultaneously with UV light and with broad spectrum light.

25. The diagnostic system of claim 1, wherein the comparing of response signals from the at least two proximate tissue sites comprises determining whether at least two neighboring sites return a positive classification of CIN.

26. The diagnostic system of claim 1, wherein the proximate tissue sites are spaced approximately 1 mm apart along the surface of the cervical tissue.

27. A method of optically classifying cervical tissue, the method comprising the steps of:

(a) illuminating a plurality of tissue sites;

(b) detecting response signals from the plurality of tissue sites;

(c) comparing the response signals with reference signals representative of cervical tissue of known pathology and comparing response signals from at least two proximate tissue sites, the proximate tissue sites spaced less than 2 mm apart along a surface of the cervical tissue; and

(d) classifying the cervical tissue following step (c).

28. The method of claim 27, wherein step (c) comprises determining whether the at least two proximate tissue sites return a positive classification of CIN.

29. The method of claim 27, wherein the proximate tissue sites are spaced approximately 1 mm apart along the surface of the cervical tissue.