Method and apparatus for a point of care device

• US 7,604,592 B2
• Filed: 06/14/2004
• Issued: 10/20/2009
• Est. Priority Date: 06/13/2003
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique M., Mauze, Ganapati
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/560,272
• Publication Number:
  US 20060276724A1
• Time in Patent Office: 1,954 Days
• Field of Search: 600/309, 600/310, 600/345, 600/347, 600/584, 436/95, 422/68.1, 422/82.05, 422/82.06, 422/82.07, 422/82.08
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc

Abstract

A plurality of Point-of-Care (POC) tests on a single cartridge (300) is provided such that sequential or nonsequential tests may be performed in an integrated fashion without changing the test cartridge. Each cartridge can contain a penetrating member sensor (302) combination in a radial disk format, interrogated and read by a single illumination/detection device. Alternatively a series of tests can be measured electrochemically and reported. Only those tests, which are required at the time, the sample is taken need to be reported, though all tests are carried out.

Claims

1. A body fluid sampling device comprising:

a cartridge containing a plurality of penetrating members;

a drive force generator coupled to a processor and configured to be coupled to an active one of said penetrating members and to move said active one of said penetrating members;

the processor configured to provide information relative to a depth of penetration of said active one of said penetrating members through a skin surface when said active one of said penetrating members is moved; and

a plurality of analyte detecting members each associated with one of said penetrating members, the plurality of analyte detecting members being attached to a bottom surface of said cartridge, wherein a first portion of the analyte detecting members measure a first analyte and a second portion of the analyte detecting members measure a second analyte.

2. The device of claim 1 wherein the penetrating member driver is coupled to a position sensor in communication with the processor, said position sensor used to detect a position of the active one of said penetrating members while penetrating tissue.

3. The device of claim 1 wherein said first portion of analyte detecting members are all located on one area of the cartridge while said second portion of analyte detecting members are all located on a second area of the cartridge.

4. The device of claim 1 wherein said first portion of analyte detecting members measure analytes related to blood gases.

5. The device of claim 1 wherein said second portion of analyte detecting members measure analytes related to electrolytes.

6. The device of claim 1 wherein said second portion of analyte detecting members measure analytes related to at least one of the following:

blood gases, electrolytes, coagulation, or metabolites.

7. The device of claim 1 further comprising a handheld, two way communication, data management system.

8. The device of claim 1 further comprising an integrated sampling/POC testing device for one step sample to read.

9. The device of claim 1 wherein body fluid requirement for each analyte detecting member is less than 1 microliter.

10. The device of claim 1 wherein the processor is configured to measure the first and the second analyte while reporting only those results which are desired at the time the sample is taken.

11. The device of claim 1 wherein said analyte detecting members use either electrochemical, optical, or combinations of the measurement techniques.

12. The device of claim 1 further comprising a companion cartridge wherein additional analyte detecting members are coupled for more complex less common tests if required.

13. The device of claim 1 further comprising vents, seals, and/or fill detectors.

14. The device of claim 1 further comprising a cartridge vent system that opens by piercing mechanism to allow on board calibration fluids to start flowing into relevant fluidic structures.

15. A body fluid sampling device comprising:

a cartridge containing a plurality of penetrating members;

a plurality of analyte detecting members each associated with one of the plurality of penetrating members on said cartridge, wherein a first portion of the analyte detecting members measure a first analyte and a second portion of the analyte detecting members measure a second analyte;

a penetrating member driver for moving an active one of said penetrating members from a first position outward to penetrate tissue; and

many tests on a single penetrating member/analyte detecting member combination.

16. A body fluid sampling device comprising:

a cartridge containing a plurality of penetrating members;

a plurality of analyte detecting members each associated with one of the plurality of penetrating members on said cartridge, wherein a first portion of the analyte detecting members measure a first analyte and a second portion of the analyte detecting members measure a second analyte;

a penetrating member driver for moving an active one of said penetrating members from a first position outward to penetrate tissue;

an upstream fixed volume chamber which empties instantaneously when full so that all tests start simultaneously.

17. A body fluid sampling device comprising:

a cartridge containing a plurality of penetrating members;

a plurality of analyte detecting members each associated with one of the plurality of penetrating members on said cartridge, wherein a first portion of the analyte detecting members measure a first analyte and a second portion of the analyte detecting members measure a second analyte;

a penetrating member driver for moving an active one of said penetrating members from a first position outward to penetrate tissue;

an array detection having a storage area having a sensing area;

another storage area having an enzyme area separate from the sensing area prior to tissue piercing;

wherein said storage areas and sensing area are positioned to cause fluid to first flow to the enzyme area and then to the sensing area.

18. A method of body fluid sampling comprising:

moving a penetrating member conforming to a selectable velocity profile or motion waveform;

piercing a storage area having a sensing area;

piercing another storage area having an enzyme area separate from the sensing area prior to piercing;

causing fluid to first flow to the enzyme area and then to the sensing area.

19. The method of claim 18 further comprising storing said enzyme area in an inert environment different from an environment for the sensing area.

20. A device for body fluid sampling usable with a cartridge housing a plurality of penetrating members, the device comprising:

a housing;

a penetrating member driver coupled to said housing and for use with said cartridge;

a processor for controlling said penetrating member driver to move at least one of said penetrating members at velocities which conform with a selectable velocity profile;

a storage area having a sensing area;

another storage area having an enzyme area separate from the sensing area prior to piercing;

wherein said penetrating member pierces opens both storage areas upon member actuation and causes body fluid to first flow to the enzyme area and then to the sensing area.