Medical diagnostic system

• US 5,279,294 A
• Filed: 03/26/1990
• Issued: 01/18/1994
• Est. Priority Date: 04/08/1985
• Status: Expired due to Fees

• Current Assignee: Arthur R. Kudd, Judson M. Dayton, Queststar Medical, Inc.
• Original Assignee: Cascade Medical, Inc.
• Inventors: Anderson, Paul J., Jones, Richard E., Christenson, Paul E., Linde, David R., Jessen, Ross A., Walter, Bert
• Primary Examiner(s): Shay, David M.
• Application Number:
  US07/499,085
• Time in Patent Office: 1,394 Days
• Field of Search: 128/770, 128/771, 128/763, 128/636, 128/637, 128/633, 128/634, 128/632, 356/39-42, 606/181, 606/182
• US Class Current: 600/322
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72

Abstract

Hand-held shirt-pocket portable instrument for quantitative measurement of glucose or analysis in biological fluids. The system accepts a disposable diagnostic reagent test device which has a reagent carrier and mode of identifying to the instrument the reagent lot characteristics. The instrument includes a housing structure having a visual LCD readout, a microprocessor, and photosensing circuitry which measures the change of color of the reagent carrier upon reaction in the reacting chemistry of the disposable test device. The housing also includes a spring arrangement for actuating a disposable lancet into the skin for generating blood. The disposable diagnostic reagent unit includes a configuration for transporting of the blood in the regent unit. The system includes verification and calibration sequences for the electronics, the chemistry of an unused disposable unit, the presence of a blood sample, and the ambient temperature. The system also provides for storing a plurality of analysis readings.

Claims

1. System for extraction and analysis of a component of a liquid, said system receiving a disposable diagnostic reagent unit which exhibits a color change on sensing a predetermined component in the liquid, said system comprising:

a. optical measurement means including a light source and light sensor for measuring light emanating from said source and reflected by reagent chemistry in said unit and having an optical characteristic proportional to the component of a liquid to be measured after transporting said liquid to said reagent;

b. said optical measurement means also for generating an electrical signal responsive to a change of said reagent chemistry and therefore also to the component to be measured;

c. microprocessor means for processing said generated electrical signal;

d. display means responsive to said processed signal for providing a visual readout representative of the analysis on said display means in said housing member; and

,

e. means for removably receiving a disposable diagnostic reagent unit including said reagent chemistry.

2. System for extraction and analysis of a component of blood in a body, said system receiving a disposable diagnostic reagent unit which exhibits a color change on sensing a predetermined condition, said system comprising:

a. housing member including a spring actuated hammer means in said housing member for driving a lancet and a disposable lancet removably positioned on said hammer means;

b. optical measurement means including a light source and light sensor for measuring light emanating from said source and reflected by blood reagent chemistry in said unit and having an optical characteristic proportional to the component of a liquid to be measured after transporting said liquid to said reagent;

c. said optical measurement means also for generating an electrical signal responsive to a change of said blood reagent chemistry and therefore also to the component to be measured;

d. microprocessor means for processing said generated electrical signal;

e. display means responsive to said processed signal for providing a visual readout representative of the analysis on said display means in said housing member; and

,

f. means for removably receiving a disposable diagnostic reagent unit including said blood reagent chemistry.

3. Hand-held pocketable medical monitoring diagnostic system for extraction and analysis of a component of blood in a body, said system comprising:

a. pocketable housing member including a spring actuated hammer means in said housing member for driving a means for puncturing and a disposable lancet removably positioned on said hammer means;

b. optical measurement means including a light source and light sensor for measuring light emanating from said source and reflected by blood reagent chemistry having a color optical characteristic proportional to the component of a liquid to be measured when in contact with said liquid;

c. said optical measurement means for generating an electrical signal responsive to a color change of said blood reagent chemistry and therefore also to the component to be measured;

d. microprocessor means for processing said generated electrical signal;

e. display means responsive to said electrical signal for providing a visual readout representative of the analysis on said display means in said housing member;

f. means for removably receiving a disposable diagnostic reagent unit; and

,

g. disposable diagnostic reagent unit for operative engagement in said receiving means of said glucose medical monitoring diagnostic system, said unit including housing means for operatively connecting said unit to said receiving means of said system, said blood reagent chemistry supported within said housing, at least one opening in said housing means includes means for said means for puncturing to pass through and means for transporting a liquid substance to said blood reagent chemistry, means for transporting said liquid substance to said blood reagent chemistry, and aperture means through said housing for reading a portion of said blood reagent chemistry whereby said blood reagent chemistry yields a responsive optical characteristic which is read by said optical measurement means, processed by said microprocessor means, and displayed by said display means thereby yielding a numerical value useful for diagnosing a condition.

4. The system of claim 3 wherein said transporting means is a wicking material.

5. The system of claim 3 wherein said blood reagent chemistry is glucose oxidase.

6. The system of claim 3 including means to return said hammer means to an original rest position.

7. The system of claim 3 including cocking means for storing energy in said spring and connected to said hammer means.

8. The system of claim 3 including means for excluding ambient light including a light-tight enclosure of said housing of said unit.

9. The system of claim 3 including a calibration sensor for sensing visual calibration color said reagent chemistry at predetermined times as sequenced by said microprocessor means.

10. The system of claim 3 including piezoelectric audio means, said audio means being connected to said microprocessor means for beeping on predetermined conditions.

11. The system of claim 3 wherein said microprocessor means includes means for displaying operational messages on said display means.

12. The system of claim 3 wherein said microprocessor means includes means for displaying a plurality of previous readings.

13. The system of claim 3 including a dust cover adjacent to said optical measurement means, and said dust cover including a calibration chart means for reading by said optical measurement means.

14. The system of claim 3 wherein said housing is rectangular.

15. The system of claim 3 including means for clipping into a shirt pocket of a user.

16. The system of claim 3 including means in said housing for allowing batteries to be replaced battery replacement.

17. The system of claim 3 including switch means on said housing and connected to said microprocessor means for setting and displaying time.

18. The system of claim 3 including means in said microprocessor for displaying numerical values in the English system and metric system.

19. The system of claim 3 wherein said microprocessor means includes a four bit microprocessor.

20. The system of claim 3 wherein said reagent chemistry is a solid.

21. The system of claim 3 wherein said optic measurement means comprises two LED'"'"'s and a photodiode.

22. The system of claim 3 wherein said housing is of a size to comfortably fit in a users hand.

23. The system of claim 3 including a dust cover means rotatable on said housing for protecting said said optical measurement means.

24. The system of claim 23 including calibration means internally mounted on said dust cover means for reading by said optical measurement means.

25. The system of claim 24 including means in said microprocessor to verify LOT/LOT reagent specific calibration codes of said calibration means.