Blood sampler and component tester with guide member

• US 5,231,993 A
• Filed: 11/20/1991
• Issued: 08/03/1993
• Est. Priority Date: 11/20/1991
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Smedley, William H., Haber, Terry M.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Tucker, Guy V.
• Application Number:
  US07/795,133
• Time in Patent Office: 622 Days
• Field of Search: 128/763, 128/770, 128/760, 128/762, 128/767, 128/743, 606/181, 606/182, 606/167, 606/185, 206/568, 206/569, 206/570, 206/363, 206/365, 206/366, 206/367
• US Class Current: 600/583
• 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 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A reagent strip (10) and lance (6) are integrated to form a blood sampler and component tester (2). The reagent strip (10) is adapted for application against the skin of a patient and carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith. The lance (6), which is used to pierce the skin of a patient, is coupled to the reagent strip (10) through a resilient dome (4) which translates the lance between an extended position (where the lance through a guide member (20) extends beyond the reagent strip to puncture the skin of a patient) and a retracted position.

Claims

1. A device for testing the concentration of a blood component present in a blood sample, said device comprising:

a member adapted for application against the skin of a patient, said member carrying a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith;

a lance for piercing the skin of a patient, said lance having a proximal end and a distal end;

a flexible dome-shaped member for translating said lance between a first position where the distal end of said lance is positioned on one side of said reagent carrying member and a second position where the distal end of said lance is positioned on another side of said reagent carrying member, said dome-shaped member being coupled to the proximal end of said lance;

a substrate comprising a layer of material that is positioned between said dome-shaped member and said reagent carrying member; and

a guide member for guiding said lance through said substrate and said reagent carrying member.

2. The device for testing the concentration of a blood component present in a blood sample of claim 1 further comprising a chart having regions of different hue, whereby the hue of the reagent after the reagent has reacted with a blood sample is compared to at least one of said regions to determine the sugar level of the blood sample.

3. The device of claim 2 wherein said chart and substrate are integrated in a single construction.

4. The device of claim 3 wherein said substrate comprises clear plastic.

5. The device of claim 3 wherein said dome-shaped member and substrate comprise clear plastic.

6. A device for testing the concentration of a blood component present in a blood sample, said device comprising:

a member adapted for application against the skin of a patient, said member carrying a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith;

a lance for piercing the skin of a patient, said lance having a proximal end a distal end; and

a flexible dome-shaped member for translating said lance between a first position where the distal end of said lance is positioned on one side of said reagent carrying member and a second position where the distal end of said lance is positioned on another side of said reagent carrying member said dome-shaped member being coupled to the proximal end of said lance;

a substrate comprising a layer of material that is positioned between said dome-shaped member and said reagent carrying member;

said substrate includes an opening, said opening being aligned with said lance such that said lance extends through said opening when said lance is in said second position; and

a hub member for guiding said lance through said substrate, said hub member having a central aperture aligned with said opening in said substrate.

7. The device of claim 6 wherein said reagent carrying member comprises paper.

8. The device of claim 6 wherein said reagent comprises a substance that changes color according to the sugar level of a blood sample placed in contact therewith.

9. The device of claim 6 wherein said dome-shaped member and said lance are integrally formed as a single piece.

10. The device of claim 6 wherein said dome-shaped member comprises means for biasing said lance away from said reagent carrying member.

11. The device of claim 6 wherein said dome-shaped member is fixedly secured to said substrate.

12. The device of claim 6 wherein said lance includes a portion having a lateral dimension greater than the corresponding lateral dimension of said central aperture, thereby limiting the length of the lance that can extend beyond said reagent pad when said lance is in said second position.

13. The device of claim 6 further including a protective strip of material releasably secured to said reagent carrying member.

14. The device of claim 6 further including a color code integrated therewith, said color code having regions of different color, whereby the color of the reagent after reaction with a blood sample is compared to at least one of said color regions to determine the sugar level of the blood sample.

15. The device of claim 6 further including a pad that carries at least a portion of said reagent, said pad being coupled to said reagent carrying member.

16. The device of claim 15 wherein said pad is adhesively attached to said reagent carrying member.

17. The device of claim 15 wherein said pad is mechanically attached to said reagent carrying member.

18. The device of claim 15 wherein said pad is embedded in said reagent carrying member.

19. A diagnostic system including a plurality of disposable modules that are coupled in series, each module comprising:

a member that carries a reagent which changes color according to sugar present in a substance placed in contact therewith;

an actuator coupled to said reagent carrying member;

a layer of material positioned between said actuator and said carrying member, said layer of material including an aperture;

a lance that extends from said actuator in a direction toward said reagent carrying member; and

means for guiding said lance through said aperture.

20. The system of claim 19 wherein said actuator comprises a member having a flexible convex portion.

21. A method for monitoring blood glucose level in a pate int comprising the steps of:

providing a module with a carrier carrying a sugar sensitive reagent, a lance movingly mounted relative to the carrier, and a guide member;

placing the module against the skin of a patient;

guiding the lance in the guide member toward the carrier;

reciprocating the lance through the carrier a distance sufficient to puncture the patient'"'"'s skin and draw a capillary blood sample;

applying at least a portion of the blood sample to the reagent.

22. The method for monitoring blood glucose level in a patient of claim 21 further comprising the step of comparing the hue of the reagent that has reacted with the blood sample with the different regions of a chart carried by the module to determine the blood glucose level.