Medical droplet whole blood and like monitoring

• US 5,047,044 A
• Filed: 02/23/1990
• Issued: 09/10/1991
• Est. Priority Date: 10/12/1988
• Status: Expired due to Fees

• Current Assignee: Roger E. Smith, 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
• Application Number:
  US07/484,154
• Time in Patent Office: 564 Days
• Field of Search: 128/760, 128/762, 128/771, 606/181-183, 204/206, 206/569-571
• US Class Current: 606/182
• 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 interacts 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. Multiple lancet structure comprising:

instrument means;

packet means associated with the instrument means and comprising a plurality of closely associated individually usable and disposable finger piercing elements for respective sequential acquisition of blood droplets, biasing means associated with each finger piercing element by which the associated finger piercing element when in a ready to use position in the instrument means is displaced to penetrate a fingertip or other patient site and thereafter retracted.

2. Multiple lancet structure according to claim 1 wherein the biasing means comprise a single element.

3. Multiple lancet structure according to claim 1 wherein the packet means comprises means encapsulating each associated finger piercing means and biasing means and frangible linkage means serially joining together the encapsulating means.

4. Multiple lancet structure according to claim 3 wherein tab means are disposed at the distal end of at least one encapsulating means.

5. Multiple lancet structure according to claim 1 further comprising connector means by which the packet means are accurately matched to and aligned with the instrument means.

6. Multiple lancet structures according to claim 1 wherein the packet means comprise housing means encapsulating each associated finger piercing element and biasing means, in substantially concealed relation, each housing means comprising port means by which the encapsulated finger piercing element is displaced and retracted.

7. Multiple lancet structure according to claim 1 wherein each biasing means are disposed within the packet means in a cocked condition counter to memory of each biasing means.

8. Multiple lancet structure comprising:

disposable encapsulating means;

a plurality of individually usable and disposable finger piercing elements each carried within the encapsulating means for respective sequential acquisition of blood droplets;

a plurality of biasing means one associated with each finger piercing element within the encapsulating means by which the associated finger piercing element is selectively actuated to leave the encapsulating means and penetrate a fingertip or other patient site and thereafter retract under reverse force of the associated biasing means into the encapsulating means.

9. Multiple lancet structure according to claim 8 wherein the biasing means comprise a single biasing element.

10. Multiple lancet structure according to claim 8 further comprising instrument means into which the encapsulating means with finger piercing means and biasing contained therein are inserted.

11. Multiple lancet structure according to claim 10 wherein the encapsulating means further comprise detent means by which the encapsulating means are held in a selected position in respect to the instrument, the detent means accommodating indexing of the encapsulating means in respect to the instrument.

12. Multiple lancet structure according to claim 11 wherein the detent means comprise spaced notches in the encapsulating means.

13. Multiple lancet structure according to claim 8 wherein the encapsulating means comprise frangible segments each containing one finger piercing means with its associated biasing means.

14. Multiple lancet structure according to claim 13 wherein manual separation of one frangible segment from another exposes pathway means in the encapsulating means for selective reciprocation of finger piercing means.

15. Multiple lancet structure according to claim 8 wherein each biasing means are disposed within the encapsulating means in a cocked condition counter to memory of each biasing means.

16. Multiple lancet structure according to claim 8 further comprising actuator means carried by the encapsulating means adjacent each biasing means for selectively causing the biasing means to displace the associated finger piercing means.

17. A method of accommodating the provision of sequential droplet samples of blood comprising the steps of:

placing a packet of individual encapsulated separately biased finger piercing elements in a receptacle of an instrument;

securing the packet in a releasibly restrained condition within the receptacle so that one end of the packet is exposed at the distal end of the instrument;

uncovering egress/ingress pathway means to one finger piercing element at the distal end of the sensor encapsulating packet;

selectively actuating the distal finger piercing element by releasing said bias whereby said distal finger piercing element is reciprocated along the egress/ingress pathway means to penetrate a fingertip or the like of a medical patient and thereafter to retract the distal finger piercing means into the encapsulation;

indexing the packet distally against said restraint until the distal encapsulated finger piercing element and at least part of the next encapsulating finger piercing element is exposed beyond the distal end of the instrument;

manually breaking the packet between the two exposed piercing elements to uncover the egress/ingress pathway means to the next enclosed encapsulated piercing element.

18. A method according to claim 17 wherein the recited steps are repeated until the supply of the encapsulated piercing elements of the packet are exhausted.