Medical droplet whole blood and like monitoring

• US 4,995,402 A
• Filed: 10/12/1988
• Issued: 02/26/1991
• Est. Priority Date: 10/12/1988
• Status: Expired due to Fees

• Current Assignee: Thorne Smith Astill Technologies Incorporated
• Original Assignee: Thorne Smith Astill Technologies Incorporated
• Inventors: Thorne, Gale H., Smith, Roger E., Smith, Jay L., Astill, Mark E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/256,678
• Time in Patent Office: 867 Days
• Field of Search: 128/760, 128/762, 128/771, 606/181-183, 204/206, 206/569-571
• US Class Current: 600/584
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/6816 characterised by the detection means C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 1/6823 Release of bound markers
• CPC Class Codes: C12Q 2563/137 Metal/ion, e.g. metal label
• CPC Class Codes: C12Q 2565/607 being a sensor, e.g. electrode
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/5438 Electrodes
• CPC Class Codes: G01N 33/581 with enzyme label (including co-enzymes, co-factors, enzyme inhibitors or substrates)
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 435/81 Packaged device or kit

Abstract

An assay employing a tracer comprising a ligand having a mercury label wherein mercury label is released from at least one of a bound or free tracer phase and iunteracts with a metal. Analyte is determined by a change in at least one property of the metal caused by such interaction. The invention also relates to a device for such an assay wherein mercury ions released from a free or bound tracer are caused to eventually amalgamate with a metal, and the presence and/or amount of analyte is determined by changes in the metal resulting from the eventual amalgamation which may be measured electrically or by other means. The invention also relates to novel assay instruments, novel lancets, assay sensors, assay sensor packets, instrumentation and combinations of assay components, and related methods.

Claims

1. Whole blood analyte sensor structure comprising:

packet means comprising a plurality of disposable analyte sensor means for respective sequential use in testing of samples of whole blood for a predetermined analyte, the packet means comprising means by which the sensor means are contemporaneously loaded into an analyte instrument and means by which sensor means are sequentially disassociated from the packet means and discarded after use;

each sensor means comprising testing means responsive to said predetermined whole blood analyte upon delivery of the whole blood to the testing means and means by which said response is measured.

2. Whole blood analyte sensor structure according to claim 1 wherein the sensor means of the packet means are joined one to the next in series by frangible linkage means.

3. Whole blood analyte sensor structure according to claim 2 wherein the load means comprise distally disposed insertion tab means for manual grasping and manipulation.

4. Whole blood analyte sensor structure according to claim 1 further comprising proximal end connector means by which the packet means are accurately matched to, aligned with and releasibly attached to the analyte instrument.

5. Whole blood analyte sensor structure according to claim 1 wherein the testing means of each sensor means comprise mercury-aluminum interacting means.

6. Whole blood analyte sensor structure according to claim 1 wherein each measure means comprise means for ascertaining electrical responsive activity at the testing means.

7. Whole blood analyte sensor structure according to claim 6 wherein each sensor means comprise electrical conductor means by which the ascertained electrical test activity is communicated to a site remote from the sensor packet.

8. Whole blood analyte sensor structure according to claim 7 wherein the electrical conductor means comprise means by which the presence and adequacy of a whole blood sample is electrically ascertained.

9. Whole blood analyte sensor structure according to claim 1 wherein the whole blood analyte testing means of each sensor means comprise electrode means which are common to all sensor means by which test activity sequentially occurring at the respective whole blood analyte testing means of successively used sensor means is sensed and communicated to a site remote from the packet means.

10. Whole blood analyte sensor structure according to claim 1 further comprising housing means in which each testing means are disposed in substantially concealed relation, the housing means comprising means by which whole blood is displaced to the testing means of each sensor means

11. Whole blood analyte sensor structure according to claim 1 wherein the sensor means of the packet means are serially connected by linkage means, the packet means further comprising detent means by which the packet means are held in a selected position in respect to the instrument, the detent means accommodating indexing of the packet means in respect to the instrument.

12. Whole blood analyte sensor structure according to claim 11 wherein the detent mean comprise spaced notches.

13. Whole blood analyte sensor structure according to claim 1, the packet means further comprising electrical communicating means and proximal end means by which the packet means are physically and electrically connected in matched and aligned relation to the analyte instrument.

14. Whole blood analyte sensor structure according to claim 1 wherein the packet means comprise electrical communicating means extending through each sensor testing means, the packet means further comprising electrical calibration means in electrical contact with the electrical communicating means.

15. Whole blood analyte sensor structure according to claim 1 further comprising lancet means carried by each sensor means comprising means for piercing the skin and subcutaneous tissue of a medical patient to obtain a liquid whole blood sample for delivery to the testing means.

16. Whole blood analyte sensor structure according to claim 15 wherein the lancet means comprise means precocking the piercing means.

17. Whole blood analyte sensor structure according to claim 16 further comprising means encapsulating the testing means and each precocked lancet means of each sensor means of the packet means.

18. Whole blood analyte sensor structure according to claim 17 comprising actuator means juxtaposed the lancet means for releasing the lancet means from its precocked condition.

19. Whole blood analyte sensor structure according to claim 18 wherein the actuator means comprise frangible means of the encapsulating means.

20. Liquid analyte sensor structure comprising:

packet means comprising a plurality of disposable analyte sensor means for respective sequential testing of liquid for analyte, the packet means comprising means by which the sensor means are contemporaneously loaded into analyte instrument means;

each sensor comprising testing means to which analyte liquid is delivered, the testing means being carried by support structure.

21. Liquid analyte sensor structure according to claim 20 wherein the sensor means of the packet means are joined one to the next in series by frangible linkage means.

22. Liquid analyte sensor structure according to claim 20 wherein the load means comprise distally disposed insertion tab means.

23. Liquid analyte sensor structure according to claim 20 further comprising proximal end connector means by which the packet means are accurately matched to and aligned with the analyte instrument.

24. Liquid analyte sensor structure according to claim 20 wherein the testing means of each sensor means comprise means measuring test activity.

25. Liquid analyte sensor structure according to claim 24 wherein each measuring means comprise means for ascertaining electrical activity at the testing means.

26. Liquid analyte sensor structure according to claim 25 wherein each sensor means comprise electrical conductor means by which the ascertained electrical test activity is communicated to a site remote from the testing means.

27. Liquid analyte sensor structure according to claim 20 wherein the testing means of each sensor means comprise electrode means which are common to all sensor means by which test activity sequentially occurring at the respective analyte testing means of successively used sensor means is sensed and communicated to a site remote from the packet means.

28. Liquid analyte sensor structure according to claim 20 wherein each sensor means comprise mercury-aluminum testing means.

29. Liquid analyte sensor structure according to claim 20 wherein the support structure comprises housing means in which each testing means are disposed in substantially concealed relation, the housing means comprising means by which liquid sample is displaced to the testing means of each sensor means.

30. Liquid analyte sensor structure according to claim 20 wherein the sensor means of the packet means are serially releasibly linked together, the packet means further comprising detent means by which the packet means are held in a selected position in respect to the instrument, the detent means accommodating indexing of the packet means in respect to the instrument.

31. Liquid analyte sensor structure according to claim 30 wherein the detent means comprise spaced notches in the support means.

32. Liquid analyte sensor structure according to claim 20, the packet means further comprising electrical communicating means and proximal end means by which the packet means are physically and electrically connected in matched and aligned relation to the instrument.

33. Liquid analyte sensor structure according to claim 20 wherein the packet means comprise electrical communicating means extending through each sensor testing means, the packet means further comprising electrical calibration means in electrical contact with the electrical communicating means.

34. Liquid analyte sensor structure according to claim 20 further comprising lancet means carried by each sensor means comprising means for piercing the skin and subcutaneous tissue of a medical patient to obtain a liquid sample comprising whole blood for delivery to the testing means.

35. Liquid analyte sensor structure according to claim 34 wherein the lancet means comprise means precocking the piercing means.

36. Liquid analyte sensor structure according to claim 35 wherein the support structure comprises means encapsulating the testing means and the precocked lancet means of each sensor means of the packet means.

37. Liquid analyte sensor structure according to claim 36 comprising actuator means juxtaposed the lancet means for releasing the lancet means from its precocked condition.

38. Liquid analyte sensor structure according to claim 37 wherein the actuator means comprise frangible means of the encapsulating means.