APPARATUS AND METHOD FOR NON-INVASIVELY DETECTING DISEASES THAT AFFECT STRUCTURAL PROPERTIES IN BIOLOGICAL TISSUES

• US 20120203086A1
• Filed: 11/07/2011
• Published: 08/09/2012
• Est. Priority Date: 11/05/2010
• Status: Active Grant

• Current Assignee: Sinocare Meditech, Inc.
• Original Assignee: Freedom Meditech, Inc.
• Inventors: RORABAUGH, Dale A., DAVIS, Neil M., BRANCACCIO, Vincent F., WILLIAMS, Paul
• Granted Patent: US 8,989,848 B2
• Time in Patent Office: Days
• US Class Current: 600/321
• CPC Class Codes: A61B 3/1173 for examining the eye lens
• CPC Class Codes: A61B 5/0068 Confocal scanning
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: G01N 21/6486 Measuring fluorescence of biological material, e.g. DNA, RNA, cells G01N21/6428 takes precedence
• CPC Class Codes: G01N 21/65 Raman scattering
• CPC Class Codes: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism

Abstract

Apparatus and methods for spectroscopic analysis of biological tissues to classify an individual as diabetic or non-diabetic, or to determine the probability, progression or level of a disease or medical condition in an individual.

Claims

1. An apparatus for determining characteristics of biological tissue or other medium of a subject, comprising:

a. means for illuminating the medium with electromagnetic radiation directed into the medium, thereby causing the medium to react with a first action selected from the group consisting of reflecting, backscattering, transmitting, and emitting responsive radiation and a second action selected from the same group excluding the first action;

b. means for collecting the responsive radiation;

c. means, connected to the collecting means, for separating the collected radiation into a plurality of components;

d. means, connected to the separating means, for (i) measuring the intensity of each of the separated plurality of components and (ii) determining a mathematical relationship between the separated plurality of components;

e. LED fixation means for guiding the subject to self-align itself along an axis.

2. An apparatus according to claim 1 in which the illuminating means comprises:

a. a light source selected from the group consisting of lasers, laser diodes, laser diodes coupled to nonlinear frequency doubling devices, light emitting diodes and broadband sources coupled to optical filters;

b. a lens, optically responsive to the light from the light source, for focusing the light; and

c. a lens system, optically responsive to the focused light, having a focus, and defining an aperture at its focus of less than approximately 1 cm.

3. An apparatus according to claim 1 in which the illuminating means causes the medium to react by emitting responsive radiation, further comprising means for measuring the time difference between illumination of the medium and emission of the responsive radiation.

4. An apparatus for measuring molecular changes in a patient having an ocular lens that, when illuminated, is capable of backscattering radiation including fluorescent and Rayleigh components of determinable intensities, comprising:

a. means for illuminating the ocular lens with light having a wavelength between approximately 400-480 nm, thereby causing the ocular lens to backscatter radiation in response to the illumination;

b. means, responsive to the backscattered radiation, for collecting the backscattered radiation;

c. means, connected to the collecting means, for separating the backscattered radiation into its fluorescent and Rayleigh components;

d. means, connected to the separating means, for (i) detecting the intensity of each of the separated fluorescent and Rayleigh components and (ii) forming the ratio of the detected intensities, thereby producing a measurement of molecular changes in the ocular lens and

e. LED fixation means for guiding the subject to self-align itself along an axis.

5. An apparatus according to claim 4 in which the illuminating means comprises:

a. a light source selected from the group consisting of lasers, laser diodes coupled to nonlinear frequency doubling devices, light emitting diodes, and broadband sources coupled to optical filters;

b. a lens, optically responsive to the light from the light source, for focusing the light; and

c. a lens system, optically responsive to the focused light, having a focus, and defining an aperture at its focus greater than approximately fifteen micrometers.

6. An apparatus according to claim 5 further comprising an eyepiece means, responsive to the backscattered radiation, for permitting an operator to view the ocular lens.

7. An apparatus according to claim 6 in which the separating means comprises at least one dichroic beam splitter.

8. An apparatus according to claim 7 in which the detecting and forming means comprises at least one single chip silicon detector and the wavelength of the fluorescent component of the backscattered radiation is selected from the group consisting of between approximately 460-500 nm and 520-600 nm.

9. An apparatus according to claim 8 in which the detecting and forming means further comprises an amplifier.

10. An apparatus according to claim 9 in which the illuminating means further comprises means for adjusting the power level of the illuminating light.

11. An apparatus for measuring molecular changes in a patient having an ocular lens having a volume that, when illuminated, is capable of backscattering radiation including fluorescent and Rayleigh components of determinable intensities, comprising:

a. a blue LED for providing light having a selected wavelength and power level;

b. means, optically responsive to the provided light, for adjusting the power level of the light;

c. a lens, optically connected to the adjusting means, for focusing the light;

d. a first optical fiber, optically connected to the lens, for receiving the focused light;

e. a lens system, optically connected to the first optical fiber and defining an aperture having a focus greater than approximately fifteen micrometers, for delivering the focused light to a selected approximately two hundred micrometers of the volume of the ocular lens, thereby causing the ocular lens to backscatter radiation in response to the delivered light;

f. a collector (i) having a focal point encompassing the selected volume of the ocular lens to which the focused light is delivered and (ii) responsive to the backscattered radiation, for collecting the backscattered radiation;

g. a second optical fiber, optically connected to the collector, for receiving the collected radiation;

h. means, connected to the connecting means, for separating the backscattered radiation into its fluorescent and Rayleigh components; and

i. means, connected to the separating means, for (i) detecting the intensity of each of the separated fluorescent and Rayleigh components and (ii) forming the ratio of the detected intensities, thereby producing a measurement of molecular changes in the optical lens.

j. LED fixation means for guiding the patient to self-align itself along an axis.