Glucose medical monitoring system

• US 4,787,398 A
• Filed: 07/25/1986
• Issued: 11/29/1988
• Est. Priority Date: 04/08/1985
• Status: Expired due to Fees

• Current Assignee: Arthur R. Kudd, Judson M. Dayton, Queststar Medical, Inc.
• Original Assignee: Garid, Inc.
• Inventors: Anderson, Paul J., Linde, David E., Garcia, Fernando S., Hudson, Bertram J., Merkert, Hartmut G.
• Primary Examiner(s): Coven, Edward M.
• Application Number:
  US06/889,185
• Time in Patent Office: 858 Days
• Field of Search: 128/770, 128/771, 128/329 R, 128/314, 128/315, 128/763, 128/636, 128/637, 356/39-42
• US Class Current: 600/583
• 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 5/150022 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 glucose medical monitoring system for checking measurement of blood glucose or other body qualities. The system includes a disposable diagnostic reagent-lancet unit which carries a chemcial reagent strip of blood reacting chemistry. The system includes a housing structure having a visual LCD readout, a microprocessor, and photosensing circuitry which measures the change of color of the blood reacting chemistry of the disposable unit. The housing also includes a spring arrangement for actuating a lancet into the skin for sampling and transporting blood from a finger to a chemical reagent. The disposable unit includes medical and fluid configurations for transporting of the blood to the reagent strip. The system inlcudes verification and calibration sequences for the electronics, the chemistry of an unused disposable unit, the presence of a blood sample, and multiple readings to an average result. The system also provides for storing a plurality of readings.

Claims

1. A disposable diagnostic lancet reagent unit for operative engagement with a glucose medical monitoring diagnostic system, said system including a hammer means, said disposable unit comprising:

a. a housing;

b. means for operatively connecting said unit to said system;

c. puncturing means supported within said housing and aligned to be actuated by the hammer means and driven from within said housing through a first opening therethrough to puncture a surface adjacent said housing and cause a flow of liquid from said punctured surface;

c. blood reagent chemistry means supported within said housing;

d. fluid transporting means including said first opening in said housing for transporting a liquid substance flowing from said punctured surface to said reagent means;

e. at least one opening in said housing for providing a liquid substance to said reagent means; and

,

f. aperture means through said housing adjacent said system positioned to pass light from at least a portion of said reagent means in said diagnostic unit to a sensing means in said system for a determination of color change of said reagent means by the system whereby said color change indicates a diagnostic condition.

2. The disposable diagnostic unit of claim 1 wherein said puncturing means is movable between a retracted position in which said puncturing means is retracted substantially within said housing, and a puncturing position in which said puncturing means extends outwardly from said housing.

3. The disposable diagnostic unit of claim 2 including spring means serving to bias said puncturing means towards said retracted position.

4. The disposable diagnostic unit of claim 1 wherein said puncturing means includes a puncturing point mounted in cantilevered relationship with respect to a portion of said housing.

5. The disposable diagnostic unit of claim 3 wherein said puncturing means includes a puncturing point mounted in a cantilevered relationship with respect to a portion of said housing.

6. The disposable diagnostic unit of claim 5 wherein said puncturing means is spring biased toward said retracted position by said cantilevered relationship.

7. The disposable diagnostic unit of claim 1 wherein said puncturing means includes a puncturing end and an actuation force receiving end.

8. The disposable diagnostic unit of claim 7 wherein said housing includes opposed, substantially parallel first and second upper and lower wall portions.

9. The disposable diagnostic unit of claim 8 wherein said first and second wall portions include first and second openings respectively, each being substantially aligned with said puncturing means, and wherein said first opening is substantially aligned with said puncturing end and said second opening is substantially aligned with said actuation force receiving end.

10. The disposable diagnostic unit of claim 9 wherein said opening for providing a liquid substance to said reagent means includes said first opening.

11. The disposable diagnostic unit of claim 9 including a removable first protective barrier covering said first opening.

12. The disposable diagnostic unit of claim 11 including a second protective barrier covering said second opening.

13. The disposable unit of claim 1 wherein said fluid transporting means includes filter means for filtering at least one component from said liquid substance.

14. The disposable diagnostic unit of claim 3 wherein said spring means positions said puncturing means to travel in an arcuate path.

15. The disposable diagnostic unit of claim 1 including calibration means supported in an aperture in said housing next to said reagent means.

16. The disposable diagnostic unit of claim 1 wherein said fluid transporting means comprises a wicking means.

17. A disposable diagnostic lancet reagent unit for operating in engagement and use with a medical diagnostic system on a type having actuation means for driving of a puncturing means, connection means for operatively receiving said unit on said system and means in said system for reading a color change on the reagent means, said disposable diagnostic lancet reagent unit comprising:

a. a housing;

b. means on said housing for operatively connecting said unit to said system;

c. puncturing means supported within said housing and aligned with a first opening in said housing for allowing said puncturing means to protrude therethrough and to puncture a surface adjacent said housing and cause a flow of liquid substance from said punctured surface when driven by said actuating means;

d. reagent means, having a front side facing said surface and a back side away from said surface, supported within said housing;

e. liquid conveying means including said first opening in said housing for conveying said liquid substance from said punctured surface to said reagent means; and

,

f. aperture means through said housing at a point adjacent said system unit for conveying light from a back side portion of said reagent means to said system for determination of color change, thereby indicating a diagnostic condition.

18. The disposable diagnostic unit of claim 17 wherein said liquid conveying means includes means for filtering at least one component of said liquid substance.

19. The disposable diagnostic unit of claim 17 wherein said surface is skin and said liquid substance is blood.

20. The disposable diagnostic unit of claim 17 wherein the color change of said reagent is caused by glucose in said liquid substance and said diagnostic condition is glucose level.

21. The disposable diagnostic unit of claim 17 wherein said fluid conveying means comprises a wicking means between said first opening and said reagent means.

22. A disposable diagnostic lancet reagent unit for operating in engagement and use with a medical diagnostic system of a type having actuation means for driving of a puncturing means, connection means for operatively receiving said reagent unit on said system and means in said system for reading a color change on the reagent means, said disposable diagnostic lancet reagent unit comprising:

a. a housing including opposing finger gripping taps and a bottom plate;

b. means on said system housing for operatively connecting said reagent unit to said system;

c. puncturing means supported within said housing and a first opening in a base of said housing for allowing said puncturing means to protrude therethrough when driven by said actuating means and puncture a surface adjacent said housing and cause a flow of liquid from said puncturing surface;

d. reagent means, having a variable color responsive to the concentration of a material, supported within said housing;

e. liquid conveying means including said first opening in said housing for conveying a liquid substance from said punctured surface to said reagent means; and

,

f. aperture means through said housing for providing access for reading said reagent means for change of color by said system thereby indicating a diagnostic condition.

23. The unit of claim 22 wherein said liquid conveying means includes wicking means between said first opening and said aperture.

24. The unit of claim 22 wherein said liquid conveying means includes filter means between said reagent and said wicking means.

25. The unit of claim 22 including a second opening in said housing and a lot/lot calibration positioned about said second opening.

26. The unit of claim 22 including a sterility barrier means adhesively mounted on said bottom plate of said housing member.