Method and device for the optical spectroscopic identification of cervical cancer

• US 9,198,579 B2
• Filed: 05/11/2012
• Issued: 12/01/2015
• Est. Priority Date: 10/16/2007
• Status: Expired due to Fees

• Current Assignee: Remicalm LLC
• Original Assignee: Remicalm LLC
• Inventors: Zuluaga, Andres Felipe
• Primary Examiner(s): Jung, Unsu
• Assistant Examiner(s): Mohammed, Shahdeep
• Application Number:
  US13/469,269
• Publication Number:
  US 20120226167A1
• Time in Patent Office: 1,299 Days
• Field of Search: 600/473, 600476-478
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00186 with imaging filters
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/043 for fluorescence imaging
• CPC Class Codes: A61B 1/0646 with illumination filters
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 2560/0437 Trolley or cart-type apparatus
• 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

Abstract

A medical examination device used for the detection of pre-cancerous and cancerous tissue has an illumination source, a visualization unit, a contacting optical probe, a detector and a process unit. One embodiment of the apparatus includes both a non-contacting macroscopic viewing device (the visualization unit) for visualizing an interior surface of the cervix, as well as a fiber optic wand (contacting optical probe) for spectrally analyzing a microscopic view of the tissue.

Claims

1. A medical examination device comprising:

an illumination source, wherein the illumination source includes a lamp and a light directing device for selectably directing a beam of light from the lamp in either a first beam direction or in a second beam direction;

a visualization means positioned a set distance from a region of interest, wherein the visualization means configured for visualizing a first macroscopic image of a first macroscopic tissue site within the region of interest, wherein the visualization means receives the beam of light directed in the first beam direction from the illumination source and radiates the macroscopic tissue site with the received beam of light and visualizes the first macroscopic image from a first emitted light beam emanating from the macroscopic tissue site illuminated with the beam of light directed in the first beam direction

a fiber optic probe having a shaft, a handle, and a fiber optic bundle having a plurality of excitation fiber optic strands and a collection fiber optic strand, the excitation fibers and the collection fiber transversing the fiber optic probe from a proximal end of the probe to a transverse distal end of the probe,

wherein a proxinial end of the excitation fiber optic strands of the probe are optically coupled to the beam of light whenever the beam of light is directed in the second beam direction and wherein the proximal end of the excitation fiber optic strands at the proximal end of the probe collects the coupled beam of light and transmits the beam of light through the excitation fiber optic strands to a distal end of the excitation fiber optical strands at the distal end of the probe configured to illuminate a selected microscopic tissue are within the region of interest when in contact with the transverse distal end of the fiber optic probe,

wherein the selected microscopic tissue area is within the microscopic tissue site and wherein the visualization means configured to visualize a placement of the distal end of the probe when in contact with the microscopic tissue area when the beam of light is in the first beam direction,

and wherein a distal end of the collection fiber optic strand collects a second emitted light beam emanating from the microscopic tissue area illuminated with the beam of light transmitted by the excitation fiber optic strands and transmits the second emitted light beam to a proximal end of the collection fiber optic strand at the proximal end of the probe;

a detector in optical communication with the proximal end of the collection fiber optic strand, wherein the detector detects a plurality of emission wavelengths in the second emitted light beam; and

a processor for calculating from the detected plurality of emission wavelengths a probability that the microscopic tissue is diseased.

2. The medical examination device of claim 1, wherein the lamp includes a plurality of selectable LEDs.

3. The medical examination device of claim 1, wherein the light directing device includes a mirror that is reciprocable between a first mirror position and a second mirror position.

4. The medical examination device of claim 1, wherein the visualization means includes an ocular device wherein the user of the examination device directly views the illuminated macroscopic tissue site.

5. The medical examination device of claim 1, wherein the visualization means includes a camera for recording the first image of the macroscopic tissue.

6. The medical examination device of claim 1, wherein the collection fiber optic strand is centrally positioned in the fiber optic bundle and is surrounded by multiple coaxial excitation fiber optic strands.

7. The medical examination device of claim 1, further comprising a selectably optically transparent sheath for covering the shaft of the fiber optic probe.

8. The medical examination device of claim 1, wherein the beam of light used to illuminate the selected microscopic tissue area has a wavelength band of 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.

9. The medical examination device, of claim 1, wherein the beam of light used to illuminate the illuminated macroscopic tissue site has a wavelength band of 400-700 nm, 455-465 nm, or 410-430 nm.

10. The medical examination device of claim 8, wherein the beam of light is polarized or unpolarized.

11. A medical examination device comprising:

an illumination source, wherein the illumination source includes a lamp and a plurality of selectable engageable filters, the lamp generates a beam of light and one of the selectably engageable filters is used to filter the beam of light to a selected wavelength;

a light directing device for seleetably directing the entire filtered beam of light from the lamp in either a first beam direction or in a second beam direction;

a visualization means positioned a set distance from a region of interest, wherein the visualizing means configured for visualizing a macroscopic view of an illuminated macroscopic tissue site within the region of interest, wherein the visualization means receives the beam of light directed in the first beam direction, illuminates the macroscopic tissue site with the directed beam of the light directed in the first beam direction, and visualize a first emitted light beam emanating from the macroscopic tissue site illuminated with the directed beam of light directed in the first direction for a direct visualization of the macroscopic view of the illuminated macroscopic tissue site by a user of the examination device;

a fiber optic probe having a shaft, a handle, and a fiber optic bundle having a plurality of excitation fiber optic strands and a collection fiber optic strand,

wherein the fiber optic probe is moveable in relationship to the visualization means and in relationship to the macroscopic tissue site,

wherein a microscopic tissue area within the macroscopic tissue is selected and wherein the visualization means configured to visualize a placement of the distal end of the probe when in contact with the microscopic tissue area when the beam of light is in the first beam direction,

wherein the excitation strands of the probe are optically coupled to the beam of light whenever the beam of light is directed in the second beam direction and wherein the excitation fiber optic strands transmit the beam of light to illuminate the selected microscopic tissue area limited by a contact surface of the distal end of the fiber optic probe,

and wherein the collection fiber optic strand collects a second emitted light beam emanating from the microscopic tissue area illuminated with the beam of light transmitted by the excitation fiber optic strands;

a detector for detecting a plurality of emission wavelengths from the second emitted light beam;

a processor in communication with the illumination source, the light directing device, the fiber optic probe, and the detector; and

a user interface unit in communication with the processor, wherein the user interface unit informs the processor to selectably direct the beam of light in the first beam direction or in the second beam direction and to selectably activate the visualization unit or the fiber optic probe.

12. The medical examination device of claim 11, wherein the visualization means includes a camera for capturing an image of the illuminated macroscopic tissue site for each wavelength of a first set of selected wavelengths.

13. The medical examination device of claim 12, wherein the first set of captured images is displayed on a monitor.

14. The medical examination device of claim 11, wherein the fiber optic probe further comprises a selectably attachable optically transparent sheath for covering the shaft of the fiber optic probe.

15. The medical examination device of claim 14, wherein the distal end of the fiber optical prode and a distal end of the sheath are transverse parallel surfaces when the sheath is attached to the probe.

16. The medical examination device of claim 11, wherein the excitation strands of the fiber optic probe sequentially transmits the beam of light to the selected microscopic tissue area for each wavelength of a second set of selected wavelengths and the collection strand of the fiber optic probe collects the second emitted light beam for each wavelength of the second set of wavelengths.

17. The medical examination device of claim 16, wherein the processor calculates a probability that the microscopic tissue area is diseased from the emission wavelengths detected by the detector in the second emitted light beams collected for the second set of wavelengths.

18. The medical examination device of claim 11, wherein the detector includes a spectrophotometer and a plurality of selectably engageable filters for filtering the second emitted light beam before the second emitted light beam enters the detector.

19. The medical examination device of claim 11, wherein the collection fiber optic strand is centrally positioned and surrounded by multiple coaxial excitation fiber optic strands.

20. A method of detecting cervical cancer comprising the steps of:

generating a beam of light from an illumination source;

directing the entire beam of light in a first beam direction;

illuminating a macroscopic tissue site of a cervix with the beam of light in the first beam direction;

visualizing the illuminated macroscopic tissue site by visualizing an emitted light beam from the illuminated macroscopic tissue site;

selecting a microscopic tissue site within the illuminated macroscopic tissue site for further investigation;

watching a placement of a distal end of a fiber optic probe in contact with the selected microscopic tissue site while the macroscopic tissue site is still illuminated by the beam of light in the first beam direction;

activating a light directing device to direct the entire beam of light in a second beam direction;

generating a set of selected wavelengths from the beam of light by sequentially engaging a set of filters to filter the beam of light from the illumination source;

transmitting the set of wavelengths in the second beam direction to the fiber optic probe having a plurality of excitation optic fibers and a collection optic fiber;

sequentially transmitting the set of wavelengths through the excitation fibers to illuminate the selected microscopic tissue site, wherein a surface area of the microscopic tissue site is less than or equal to a contact surface of the distal end of the fiber optic probe;

sequentially collecting an emitted light beam emanating from the illuminated microscopic tissue site through the collection fiber for each transmitted wavelength;

transmitting each emitted light beam emanating from the illuminated microscopic tissue site to a spectrometer;

conducting a spectral analysis of each emitted light beam emanating from the illuminated microscopic tissue site using the spectrometer to generate a set of spectral data; and

calculating as probability that the selected microscopic tissue site is cancerous by comparing the spectral analysis of the selected microscopic tissue site to a spectral analysis of a known non-cancerous tissue site.

21. A method of detecting diseased cervical tissue comprising the steps of:

generating a beam of light from an illumination source having a lamp, a plurality of selectably engageable filters and a light directing device for selectably directing the beam of light in a first direction or a second direction;

directing the entire beam of light in the first beam direction;

illuminating a macroscopic tissue site of a cervix with a first set of selected wavelengths by sequentially filtering the beam of light with a set of the selectably engageable filters to generate the first set of selected wavelengths from the beam of light directed in the first beam direction;

concurrently visualizing and photographing the illuminated macroscopic tissue site by splitting a first set of emitted light beams from the macroscopic tissue site illuminated with the first set of selected wavelengths;

selecting a microscopic tissue site within the illuminated macroscopic tissue site for further investigation;

watching a placement of a transverse distal end of a fiber optic probe in contact with the selected microscopic tissue site while the macroscopic tissue site is still illuminated by the beam of light in the first beam direction;

activating a light directing device to direct the entire beam of light in a second beam direction;

generating a second set of selected wavelengths from the beam of light by sequentially engaging a set of the selectably engageable filters to filter the beam of light from the illumination source, wherein the second set of selected wavelength has at least one wavelength that is contained within the first set of selected wavelengths;

transmitting the second set of wavelengths in the second beam direction to the fiber optic probe having a plurality of excitation optic fibers and a collection optic fiber;

sequentially transmitting the second set of wavelengths through the excitation fibers to illuminate the selected microscopic tissue site, wherein the microscopic tissue site is limited by a contact surface of the distal end of the fiber optic probe;

sequentially collecting a second set of emitted light beams emanating from the illuminated microscopic tissue site through the collection fiber for each transmitted wavelength;

transmitting each emitted light beam of the second set to a spectrometer;

conducting a spectral analysis of each emitted light beam of the second set using the spectrometer to generate a set of spectral data;

recording the set of spectral data in a processor; and

calculating a probability that the selected microscopic tissue site is cancerous using programmed algorithms to analyze the set of spectral data.