Method and apparatus for monitoring blood-glucose concentration by measuring focal properties of the eye

• US 4,750,830 A
• Filed: 11/29/1985
• Issued: 06/14/1988
• Est. Priority Date: 11/29/1985
• Status: Expired due to Fees

• Current Assignee: Arnold St. J. Lee
• Original Assignee: Arnold St. J. Lee
• Inventors: Lee, Arnold St. J.
• Primary Examiner(s): Bovernick, Rodney B.
• Application Number:
  US06/803,125
• Time in Patent Office: 928 Days
• Field of Search: 351/205, 351/211, 351/221, 128/633, 356/39
• US Class Current: 351/211
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

Optical power of a living subject'"'"'s eye is measured and compared with a calibration value that corresponds to a reference blood-glucose level. The reference level is determined conventionally, as by blood analysis. Optical power of the eye increases with blood-glucose level. The comparison can include interpolation or extrapolation from two or more calibration points. Optical power is measured by projecting an image through an external optical system and through the cornea and lens of the subject'"'"'s eye onto the subject'"'"'s retina--while monitoring sharpness of focus at the retina, and systematically modifying the conditions of projection of the image. The relation between sharpness and projection conditions provides the measure of glucose concentration. For example, for presbyopic subjects, (1) the optical power of the external system may be varied, and the value of power that produces sharpest retinal focus may be used as the measure, or (2) the power may be held constant while the object distance is varied, and the distance that yields sharpest focus may be the measure. As another example, in nonpresbyopes the shortest or longest distance at which a subject can sharply focus may serve as the measure; this may be found by fixing the optical power of the external system and varying the object distance.

Claims

1. A method of obtaining information related to blood-glucose concentration in a living subject, comprising the steps of:

obtaining a test measure of the optical power of at least one eye of such subject; and

then comparing the test measure with a calibration measure of optical power that corresponds to a reference blood-glucose level in such subject, to obtain such glucose-related information.

2. The method of claim 1, further comprising the steps of:

before the test-measure-obtaining step, obtaining the calibration measure of optical power; and

substantially contemporaneously with the calibration-measure-obtaining step, determining the reference blood-glucose level in such subject.

3. The method of claim 2, wherein:

the determining step comprises analysis of the patient'"'"'s blood.

4. The method of claim 1, wherein:

the comparing step comprises noting whether the test measure is higher or lower than the calibration measure; and

such glucose-related information comprises the conclusion that such patient'"'"'s blood glucose level is, respectively, higher or lower than the reference level.

5. The method of claim 1, wherein:

the reference level is unhealthfully high;

the comparing step comprises noting whether the test measure is or is not lower than the calibration measure; and

such glucose-related information comprises the conclusion that such patient'"'"'s blood-glucose level is or is not, respectively, improved relative to the unhealthfully high reference level.

6. The method of claim 1, wherein:

the comparing step comprises comparing the test measure with a plurality of calibration measures of optical power that correspond to a respective plurality of reference blood-glucose levels in such subject; and

such glucose-related information comprises an estimate of blood-glucose concentration in such subject, calculated from the plurality of calibration measures, the corresponding plurality of reference levels, and the test measure.

7. The method of claim 1, wherein the test-measure-obtaining step comprises:

projecting an image through an external optical system, and through the cornea and lens of such subject'"'"'s eye onto such subject'"'"'s retina;

during the projecting step, monitoring the sharpness of focus of the image on such subject'"'"'s retina;

during the monitoring step, modifying the conditions of projection of the image and determining the relationship between the projection conditions and the sharpness of focus; and

using the relationship to obtain the test measure.

8. The method of claim 7, particularly adapted for such subjects who are presbyopic, and wherein:

the external optical system has adjustable optical power, and has means for indicating the value of optical power to which the system is adjusted;

the modifying and determining step comprises adjusting the optical power of the external optical system to focus the image on such subject'"'"'s retina as sharply as possible, and while the optical power is so adjusted reading the optical power of the external system from the indicating means; and

the using step comprises using the power so read as the test measure.

9. The method of claim 7, particularly adapted for such subjects who are presbyopic, and wherein:

the image is an image of an object that is at an adjustable effective distance from such subject'"'"'s eye;

the external optical system comprises means for indicating the effective distance to which the object is adjusted;

the modifying and determining step comprises adjusting the effective distance of the object to focus the image on such subject'"'"'s retina as sharply as possible, and while the effective distance is so adjusted reading the effective distance from the indicating means; and

the using step comprises using the distance so read as the test measure.

10. The method of claim 1, particularly adapted for such subjects who are substantially not presbyopic, and wherein:

the test-measure-obtaining step is performed at the far point for such eye.

11. The method of claim 1, particularly adapted for such subjects who are substantially not presbyopic, and wherein:

the test-measure-obtaining step is performed at the near point for such eye.

12. The method of claim 2, particularly adapted for such subjects who are substantially not presbyopic, and wherein:

the test-measure-obtaining step is performed at the near point for such eye and comprises;

projecting an image of an object through the cornea and lens of such subject'"'"'s eye onto such subject'"'"'s retina from an external optical system whose optical power is preadjusted to focus such subject'"'"'s eye at a relatively large distance when the eye muscles are relaxed and when such subject'"'"'s blood-glucose concentration is substantially at said reference level;

during the projecting step, monitoring the sharpness of focus of the image on such subject'"'"'s retina;

during the monitoring step, progressively changing the position of the object, from a starting position which to such subject appears at a relatively large distance, toward subsequent closer positions;

determining the closest position at which sharpness of focus of the image on such subject'"'"'s retina is maintained; and

using said closest position as the test measure of optical power at the near point.

13. The method of claim 7, wherein:

the monitoring step is performed by means of such subject'"'"'s own visual sensation of the image on the retina.

14. The method of claim 9, wherein:

the monitoring step is performed by means of such subject'"'"'s own visual sensation of the image on the retina.

15. The method of claim 12, wherein:

the monitoring step is performed by means of such subject'"'"'s own visual sensation of the image on the retina.

16. The method of claim 13, wherein:

such subject performs the projection-condition modifying step.

17. The method of claim 14, wherein:

such subject performs the optical-power adjusting step.

18. The method of claim 15, wherein:

such subject performs the effective-object-distance adjusting step.

19. The method of claim 13, wherein:

the image is an image of the retina of a particular one of such subject'"'"'s own eyes; and

the projecting step comprises illuminating the retina of that particular eye to project an image of that retina outward through the lens and cornea of that particular eye to the external optical system, for projection through the external optical system and onto the retina recited in claim 13.

20. The method of claim 7, wherein:

the projecting step comprises projecting an image that has an intensity gradient;

the monitoring step comprises automatically scanning the image of a photoelectric detector along the gradient.

21. Apparatus for obtaining information related to blood-glucose concentration in a living subject who has at least one eye that includes a lens and a retina;

said apparatus comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina;

means for adjusting the projection conditions of the external optical system in response to the optical power of said eye; and

an indicator, responsive to the adjusting means and graduated in units of blood-glucose concentration, for indicating the approximate blood-glucose concentration in such subject that corresponds to the projecton conditions of the external optical system.

29. The apparatus of claim 21, wherein:

the external optical system comprises a spectacle lens that is particularly adapted to;

correct such subject'"'"'s vision, including astigmatism if present, and

focus such subject'"'"'s eye at a relatively large distance,

when the eye muscles are relaxed and when such subject'"'"'s blood-glucose concentration is at a predetermined reference level.

30. The apparatus of claim 29, wherein:

the relatively large distance is infinity.

22. Apparatus for obtaining information related to blood-glucose concentration in a living subject who has at least one eye that includes a lens and a retina;

said apparatus comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina;

means for adjusting the projection conditions of the external optical system; and

an indicator, responsive to the adjusting means and graduated in units of blood-glucose concentration, for indicating the approximate blood-glucose concentration in such subject that corresponds to the projection conditions of the external optical system wherein the adjustable projection conditions comprise the optical power of the external optical system.

23. Apparatus for obtaining information related to blood-glucose concentration in a living subject who has at least one eye that includes a lens and a retina;

said apparatus comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina;

means for adjusting the projection conditions of the external optical system; and

an indicator, responsive to the adjusting means and graduated in units of blood-glucose concentration, for indicating the approximate blood-glucose concentration in such subject that corresponds to the projection conditions of the external optical system wherein the adjustable projection conditions comprise the effective distance of the object from such eye lens.

26. The apparatus of claim 23, further comprising:

automatic control means for controlling the adjusting means to progressively vary the effective object distance from a relatively long distance toward a relatively short distance;

automatic means for sensing sharpness of focus of the image on such retina; and

automatic means, responsive to both the automatic control means and the automatic sensing means, for causing the indicator means to indicate the blood-glucose concentration that corresponds to the shortest effective object distance at which a substantially sharp focus is sensed by the automatic sensing means.

27. The apparatus of claim 23, further comprising:

manually manipulable control means for use, by such subject or by an assistant, in controlling the adjusting means to progressively vary the effective object distance from a relatively long distance toward a relatively short distance;

automatic means for sensing sharpness of focus of the image on such retina; and

automatic means, responsive to both the manually manipulable control means and the automatic sensing means, for causing the indicator means to indicate the blood-glucose concentration that corresponds to the shortest effective object distance at which a substantially sharp focus is sensed by the automatic sensing means.

28. The apparatus of claim 23, further comprising:

manually manipulable control means for use, by such subject or by an assistant, in controlling the adjusting means to progressively vary the effective object distance from a relatively long distance toward a relatively short distance;

whereby such subject, while perceiving by such subject'"'"'s own visual sensation the degree of sharpness of focus of the image on such retina, can cause the manually controlled progressive variation of effective object distance to be halted when such subject perceives that the image is not substantially sharp; and

whereby the indicator means can be read to obtain the blood-glucose concentration that corresponds to the shortest effective object distance at which the subject perceives a substantially sharp focus.

24. Apparatus for obtaining information related to a blood-glucose concentration in a living subject who has at least one eye that includes a lens and a retina;

said apparatus being paritcularly adapted for such subjects that are presbyopic, said apparatus comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina;

means for adjusting the projection conditions of the external optical system;

an indicator, responsive to the adjusting means and graduated in units of blood-glucose concentration, for indicating the approximate blood-glucose concentation in such subject that corresponds to the projection conditions of the external optical system;

automatic means for sensing sharpness of focus of the image on such retina;

means responsive to the automatic sensng means, for controlling the adjusting means to maximize the sharpness; and

whereby the apparatus automatically focuses the image on such retina to maximum sharpness and indicates the blood-glucose concentration level in such subject that corresponds to the power of the external optical system.

25. Apparatus for obtaining information related to blood-glucose concentration in a living subject who has at least one eye that includes a lens and a retina;

said apparatus being particularly adapted fro such subjects that are presbyopic, said apparatus comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina;

means for adjusting the projection conditions of the external optical system; and

an indicator responsive to the adjusting means and graduated in units of blood-glucose concentration, for indicating the approximate blood-glucose concentration in such subject that corresponds to the projection conditions of the external optical system and wherein;

the adjusting means are manually adjustable by such living subject; and

the sharpness of focus of the image on such retina is perceptible by such subject'"'"'s own visual sensation of the image on such retina;

whereby such subject can focus the image on such retina to maximum sharpness and can read from the indicator such subject'"'"'s own blood-glucose concentration level that corresponds to the power of the external optical system.

31. Apparatus for obtaining information related to blood-glucose concentration in a living subject who has at least one eye that includes a lens and a retina;

said apparatus being particularly for use if such subject'"'"'s eye has glycemia-induced astigmatism and such astigmatism is characterized by an axis meridian, and comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina;

the image of said object on such retina including a plurality of parallel lines that are aligned substantially perpendicular to the axis meridian of glycemia-induced astigmatism in such subject'"'"'s astigmatic eye;

means for adjusting the projection conditions of the external optical system in response to the optical power of said eye; and

an indicator, responsive to the adjusting means, for providing as indication related to the projection conditions of the external optical system;

whereby the indicator provides an indication related to the approximate blood-glucose concentration in such subject that corresponds to the projection conditions; and

whereby sharpness of focus of the image onto such retina is substantially independent of glycermia-induced astigmatism exceeding that which corresponds to said predetermined blood-glucose reference level.

32. Apparatus for obtaining information related to blood-glucose concentration in a living subject whose has at least one eye that includes a lens and a retina;

said apparatus being particularly for use with such subjects whose eye-pupil dilation capability is substantially normal to at least well beyond five-millimeter pupil diameter, and comprising;

means for projecting, under adjustable projection conditions, an image of an object through an external optical system and through such eye lens onto such retina, said image appearing on a field, and said image and field being characterized by brightness;

means for adjusting the brightness of the image to a level that causes the pupil diameter of such subject'"'"'s eye to be approximately five millimeters;

means for adjusting the projection conditions of the external optical system in response to the optical power of said eye; and

an indicator, responsive to the adjusting means, for providing an indication related to the projection conditions of the external optical system;

whereby the indicator provides an indication related to the approximate blood-glucose concentration in such subject that corresponds to the projection conditions; and

whereby the relationship between said indication and such glucose concentration has a sensitivity that is substantially optimized for depth of field and aberrations.

33. The apparatus of claim 32, wherein:

the object is illuminated at roughly two to ten candelas per square meter.