Integrated blood sampling analysis system with multi-use sampling module

• US 7,537,571 B2
• Filed: 06/12/2002
• Issued: 05/26/2009
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique M., Mauze, Ganapati
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Naqi; Sharick
• Application Number:
  US10/363,507
• Publication Number:
  US 20040092842A1
• Time in Patent Office: 2,540 Days
• Field of Search: 600/573, 600/575, 600/576, 600/577, 600/578, 600/579, 600/580, 600/581, 600/582, 600/583, 600/584, 606/181, 606/182, 606/183, 606/184, 606/185, 606/186
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 15/01 specially adapted for biological cells, e.g. blood cells investigating sedimentation of particle suspensions in blood G01N15/05
• CPC Class Codes: G01N 15/06 Investigating concentration of particle suspensions by weighing G01N5/00; investigating sedimentation of particle suspensions G01N15/04; investigating individual particles G01N15/10
• CPC Class Codes: G01N 15/075 by optical means
• CPC Class Codes: G01N 2035/00891 Displaying information to the operator
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A simple, miniaturized, disposable acquisition and test module for monitoring glucose or other analytes successively for multiple times is described. The apparatus is designed to collect and test small volumes of blood in a single step. Many samples can be acquired and analyzed using a single disposable sampling module, minimizing the number of disposables and improving ease of use of the system.

Claims

1. An apparatus for collecting blood from a patient'"'"'s skin, the apparatus comprising

a disc shaped sampling module radially partitioned into a plurality of sampling segments positioned near a periphery of the disc shaped sampling module, each sampling segment having components to perform a single blood sampling and testing event and including a sampling port, a lancet having a tip, the tip adjacent the sampling port, the lancet maintained within a housing and operable to extend the lancet tip through the sampling port to pierce the patient'"'"'s skin positioned adjacent the sampling port, the disc shaped sampling module having a plurality of sample test chambers, each of a sample test chamber in fluid communication with a sampling port via a capillary channel with a diameter that is less than 0.1 mm, the sample test chambers associated with testing means, each of a sample test chamber being sized to hold no more than about 0.4 microliter of a blood sample;

a driver configured to be coupled to the lancet, the driver being associated with a driver port;

a first seal that seals each of a lancet tip prior to use;

a second seal adjacent to a lancet head that seals the driver port;

a contact interface that aligns the sampling module with a reader device; and

a rotation device coupled to the sampling module and configured to rotate the sampling module into position for a new sampling event.

2. The apparatus of claim 1, wherein each sampling segment further comprises a sampling site contoured for positioning the patients'"'"' skin, the sampling site defining an opening contiguous with the sampling port.

3. The apparatus of claim 1, wherein the sampling module includes at least 10 sampling segments.

4. The apparatus of claim 1, wherein each sampling segment is configured to allow integrated lancing, collection, and testing.

5. The apparatus of claim 1, wherein the sample test chamber is smaller than about 0.6 mm long by 0.6 mm wide by 0.4 mm deep.

6. The apparatus of claim 1, wherein each sampling segment further comprises a calibrant reservoir in fluid communication with a calibration chamber, the calibration chamber associated with calibrant testing means.

7. A blood sampling system comprising the apparatus of claim 1, the blood sampling system further comprising a reader device associated with the apparatus of claim 1.

8. The blood sampling system of claim 7 configured to allow integrated lancing of the skin, collection of blood, testing of the blood, display of information about the blood, and advancement of the apparatus of claim 1 to bring another sampling segment online.

9. A method of collecting and testing a series of blood samples, the method comprising

a) obtaining a disc shaped sampling module that is radially portioned into a plurality of sampling segments with sample test chambers, and a reader device, each sampling segment adapted to perform a single blood sampling cycle of lancing, collecting, communicating in fluid form, and testing of a blood sample, the sampling module coupled to a rotation device to rotate the sampling module into position for a new sampling event, each of a sample test chamber in fluid communication with a sampling port via a capillary channel with a diameter that is less than 0.1 mm, the sample test chambers associated with testing means, each of a sample test chamber being sized to hold no more than about 0.4 microliter of a blood sample, a driver configured to be coupled to the lancet, the driver being associated with a driver port;

a first seal that seals each of a lancet tip prior to use a second seal adjacent to a lancet head that seals the driver port;

a contact interface that aligns the sampling module with a reader device,

b) coupling the sampling module to the reader device,

c) initiating the blood sampling cycle,

d) using the rotating device to rotate the sampling module and advancing the sampling module to bring another sampling segment online,

e) repeating steps c) and d) until substantially all sampling segments on the sampling module have been used, and coupling the sampling module and reader device.

10. The method of claim 9, wherein steps c) and d) may be repeated at least 10 times before performing step f).

11. The method of claim 9, wherein each sampling segment is configured to allow integrated lancing, collection, and testing.