Apparatus and method for measuring a bodily constituent

• US 5,179,288 A
• Filed: 09/30/1991
• Issued: 01/12/1993
• Est. Priority Date: 09/30/1991
• Status: Expired due to Term

• Current Assignee: Ortho Pharmaceutical Corporation (Johnson & Johnson)
• Original Assignee: Ortho Pharmaceutical Corporation (Johnson & Johnson)
• Inventors: Hovorka, George, Miffitt, Donald, Costaris, Arthur, Poto, Edward
• Primary Examiner(s): Nelms, David C.
• Assistant Examiner(s): ALLEN, STEPHONE B
• Application Number:
  US07/769,031
• Time in Patent Office: 470 Days
• Field of Search: 250/564, 250/565, 250/573, 250/574, 128/632, 128/633, 356/36, 356/39-42, 364/413.02, 364/413.07
• US Class Current: 250/564
• CPC Class Codes: B64D 17/78 in association with other load-retarding apparatus
• CPC Class Codes: G01J 2001/4406 Plural ranges in circuit, e.g. switchable ranges; Adjusting sensitivity selecting gain values
• CPC Class Codes: G01N 2021/8494 Measuring or storing parameters of the band
• CPC Class Codes: G01N 21/27 using photo-electric detection G01N21/31 takes precedence; circuits for computing concentration logarithmic circuits G06G7/24; photometric circuits in general G01J
• 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
• CPC Class Codes: G01N 2201/126 Microprocessor processing
• CPC Class Codes: G01N 2201/12753 and storage

Abstract

An apparatus and method for measuring a bodily constituent such as glucose or cholesterol by analyzing a sample taken from the body such as blood, saliva or urine. The sample is placed on a test strip inserted into the test block portion of the apparatus where the portion of the sample containing the constituent desired to be measured reacts with a chemical reagent. Products of this reaction have an absorbance/reflectance characteristic which is mathematically related to the concentration of the constituent in the bodily sample. The reflected light is absorbed by a photodiode and the output of the photodiode converted to a digital form where a microprocessor can calculate the concentration of the constituent using the mathematical relationship between the reflected light and concentration stored in memory means of the apparatus.

Claims

1. An apparatus for measuring the concentration of a constituent in a bodily sample comprising:

a test block adapted to receive said bodily sample and adapted to receive chemical reagent means reactive with the constituent desired to be measured, said test block producing an electrical output having a mathematical relation to the concentration of said constituent,

a plurality of electrical gain devices operably connected to the test block to receive said test block electrical output,

an analog-to-digital converter capable of accepting a maximum analog input, operably connected to the electrical output of said plurality of electrical gain devices, said electrical gain devices applying electrical gain to said test block output and said analog-to-digital converter selecting the largest device output which is less than the maximum acceptable analog input,

memory means containing characterization information for said chemical reagent means and for said mathematical relation,

a microprocessor operatively connected to the output of said analog-to-digital converter to receive the digital output of said converter and operatively connected to the memory means to read the contents of said memory means, said microprocessor adapted to calculate the concentration of said constituent, and

a display means operably connected to said microprocessor to receive said calculated concentration of said constituent and display said concentration in human understandable form.

2. The apparatus of claim 1 wherein said test block comprises a light emitting diode adapted to expose said portion of constituent reacted with said chemical reagent means to electromagnetic radiation and a photodiode adapted to receive the electromagnetic radiation generated by the light emitting diode and reflected by said bodily sample reacted with said chemical reagent means and wherein said photodiode produces the electrical output having a mathematical relation to the concentration of said constituent.

3. The apparatus of claim 2 wherein said light emitting diode emits electromagnetic radiation in the visible light spectrum.

4. The apparatus of claim 1 wherein said bodily sample is a portion of blood.

5. The apparatus of claim 4 wherein said light emitting diode emits visible light of 660 nanometers.

6. The apparatus of claim 1 wherein said plurality of electrical gain devices comprises operational amplifiers.

7. The apparatus of claim 1 wherein said gain is set to be less than or equal to said maximum input of said analog-to-digital converter divided by the test block output.

8. The apparatus of claim 1 wherein a buffer is operatively connected to said selective electrical gain device, said buffer applying a voltage to said gain device in order that the output from said gain device to said microprocessor is always greater than zero and the output provided by the gain device to said microprocessor is the sum of the output of said gain device and the buffer voltage.

9. An apparatus for measuring the concentration of a constituent in a bodily sample comprising:

a test block adapted to receive said bodily sample and adapted to receive chemical reagent means reactive with the constituent desired to be measured and producing an electrical output having a mathematical relation to the concentration of said constituent,

said test block having a light emitting diode that radiates electromagnetic radiation onto said bodily sample reacted with said reagent means and a photodiode that receives electromagnetic radiation reflected from said constituent reacted with said reagent means,

said light emitting diode operably connected to a current source, the current from said current source causing said light emitting diode to emit electromagnetic radiation,

said current source operably connected to a current control means, said means regulating the electromagnetic output of said light emitting diode by providing a plurality of current source current values,

said photodiode adapted to receive electromagnetic radiation emitted by said light emitting diode and reflected by said chemical reagent means reacted with said constituent, said photodiode producing said test block output having said mathematical relation to the concentration of said constituent,

an analog-to-digital converter operably connected to said photodiode and producing a digital equivalent of said test block output,

memory means containing characterization information for said chemical reagent means and for said mathematical relation,

a microprocessor operatively connected to the out put of said analog-to-digital converter to receive the digital output of said converter and operatively connected to the memory means to selectively read the contents of said memory means, said microprocessor adapted to calculate the concentration of said constituent, and

a display means operably connected to said microprocessor to receive said calculated concentration of said constituent and display said concentration in human understandable form.

10. The apparatus of claim 9 wherein said light emitting diode radiates electromagnetic radiation in a visible light spectrum.

11. The apparatus of claim 9 wherein said microprocessor is operably connected to said current control means and said current source is regulated by said current control means such that the output of said light emitting diode is within a predetermined range calculated by said microprocessor so that the electromagnetic radiation reflected by said chemical reagent means reacted with said constituent and received by said photodiode is within a range that the photodiode produces an electrical output having an accurate mathematical relation to the concentration of said constituent.

12. The apparatus of claim 9 wherein said current control means comprises a digital-to-analog converter receiving an input from said microprocessor and receiving a further input from a fixed voltage source, said current control means having an output which is one of a plurality of voltage values.

13. The apparatus of claim 12 wherein said current source comprises a voltage to current converter circuit which receives a voltage input from the output of said current control means.

14. The apparatus of claim 9 wherein said bodily sample is blood.

15. The apparatus of claim 14 wherein said constituent in the blood is cholesterol.

16. A apparatus for self-testing to determine the concentration of cholesterol comprising:

a test block adapted to receive a bodily sample containing cholesterol and adapted to receive chemical reagent means reactive with cholesterol,

means for entering into said apparatus a characterization value associated with said reactive chemical reagent means,

an emitter and a receiver which comprise a portion of said test block, the output of said emitter impinging on the reagent means reacted with cholesterol and said receiver receiving a portion of the output after the output has interacted with the reagent means reacted with cholesterol,

means for isolating said bodily sample, said reagent means and said receiver contained within said test block from extraneous environmental noise and contaminants,

a microprocessor electrically connected to said receiver and in communication with the characterization value entered into said apparatus, adapted to calculate the concentration of cholesterol in the bodily sample deposited in the apparatus, and

a display for presenting said calculated concentration of cholesterol in a human understandable form.

17. The apparatus of claim 16 wherein said bodily sample is a portion of blood.

18. The apparatus of claim 16 wherein said chemical reagent means reactive with cholesterol comprises a test strip coated with a chemical reagent and adapted to be inserted into the test block portion of said device.

19. The apparatus of claim 16 wherein said means for entering into said device a characterization value comprises means for scrolling a menu of values on said display means and a means for entering one such value into the device.

20. The apparatus of claim 16 wherein said means for entering into said device a characterization value comprises a bar code on said chemical reagent means and a bar code reader comprising a portion of said apparatus.

21. The apparatus of claim 16 wherein said emitter is a light emitting diode.

22. The apparatus of claim 16 wherein said receiver is a photodiode.

23. The apparatus of claim 17 wherein said portion of the output of the light emitting diode received by the photodiode after having interacted with the reagent means reacted with said blood portion is reflected light.

24. The apparatus of claim 22 wherein said microprocessor is electrically connected to said photodiode by having the current output of said photodiode pass through a current to voltage converter, the voltage of which provides an input to said microprocessor.

25. A method for measuring the concentration of a constituent in a bodily sample comprising:

taking said bodily sample and reacting said sample with a chemical reagent reactive with the constituent desired to be measured,

producing an electrical output having a mathematical relation to the concentration of said constituent,

producing a plurality of voltage values each of which is a multiple of the voltage associated with said electrical output of the test block,

providing the plurality of voltages to an analog-to-digital converter,

selecting for digital processing the largest voltage of the plurality which is less than or equal to the maximum input voltage of the analog-to-digital converter,

providing the digital output of the analog-to-digital converter to a microprocessor which can address a memory means containing characterization information for said chemical reagent means,

calculating in said microprocessor the concentration of said constituent from the digital form of the test block electrical output and the characterization information for said chemical reagent means, and

displaying the calculated concentration of said constituent in human understandable form on a visible display output.

26. A method for measuring the concentration of a bodily constituent comprising:

storing in a memory device characterization information defining a mathematical relationship between the concentration of said constituent and electromagnetic radiation reflected by a chemical reagent means reacted with said constituent,

receiving in a test block a bodily sample and said chemical reagent means reactive with the constituent desired to be measured in the bodily sample,

producing electromagnetic radiation and directing it to impinge upon said constituent reacted with said reagent means,

measuring electromagnetic radiation reflected from said sample reacted with said reagent means,

producing an analog electrical output from said electromagnetic radiation reflected from said constituent reacted with said reagent means, said analog electrical output having said mathematical relationship to the concentration of said constituent,

converting said analog electrical output to a digital equivalent, controlling the amount of electromagnetic radiation impinging upon said constituent reacted with said reagent means by controlling the power provided to the source of said electromagnetic radiation to produce an analog electrical output within a predetermined range,

electronically calculating the concentration of said constituent by using the mathematical relation of the digital equivalent of the electrical output of the test block to the concentration of said constituent, and

displaying said calculated concentration of constituent in human understandable form.

27. The method of claim 26 comprising the additional steps of:

measuring the ambient electromagnetic radiation within said test block when no electromagnetic radiation is produced,

converting an analog output from such measurement into a digital value,

subtracting said ambient digital value from said digital equivalent of radiation reflected generated by impinging with electromagnetic radiation, and

performing said calculation of said constituent concentration.

28. An apparatus for measuring the concentration of a bodily constituent comprising:

a test block adapted to receive a bodily sample and adapted to receive a chemical reagent strip reactive with the constituent desired to be measured and producing an electrical output having a mathematical relation to the concentration of said constituent,

said test block having an emitter that radiates electromagnetic radiation onto said constituent reacted with said reagent strip and a receiver that receives electromagnetic radiation reflected from said constituent reacted with said reagent strip,

said test block having separate, non-intersecting passages in said test block, a first passage containing the emitter and terminating at said chemical reagent strip and a second passage containing the receiver and terminating at said chemical reagent strip, said passages forming substantially different angles with respect to the surface of the chemical reagent strip,

said test block further having a chamber with a plurality of surfaces, said surfaces disposed at individual angles to said chemical reagent strip such that electromagnetic radiation from said emitter passing through said chemical reagent strip is reflected substantially away from said chemical reagent strip,

said emitter operably connected to a current source, the current from said current source causing said emitter to emit electromagnetic radiation,

said receiver adapted to receive electromagnetic radiation emitted by said emitter and reflected by said chemical reagent strip reacted with said constituent, said receiver producing said test block output having said mathematical relation to the concentration of said constituent,

an analog-to-digital converter operably connected to said receiver and producing a digital equivalent of said test block output,

memory means containing said mathematical relation,

a microprocessor operatively connected to the output of said analog-to-digital converter to receive the digital output of said converter and operatively connected to the memory means to selectively read the contents of said memory means, said microprocessor adapted to calculate the concentration of said constituent, and

a display means operably connected to said microprocessor to receive said calculated concentration of said constituent and display said concentration in human understandable form.

29. The apparatus of claim 28 wherein said bodily sample is blood.

30. The apparatus of claim 28 wherein said constituent is cholesterol.

31. The apparatus of claim 28 wherein said emitter is a light emitting diode.

32. The apparatus of claim 28 wherein said receiver is a photodiode.

33. The apparatus of claim 31 wherein said current source is operably connected to a current control means, said means regulating the electromagnetic output of said light emitting diode by providing a plurality of current source values.