Combined lancet and electrochemical analyte-testing apparatus

• US 6,706,159 B2
• Filed: 03/02/2000
• Issued: 03/16/2004
• Est. Priority Date: 03/02/2000
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Diabetes Diagnostics, Inc. (Johnson & Johnson)
• Inventors: Moerman, Piet H. C., Stiene, Matthias, McAleer, Jerome F.
• Primary Examiner(s): Olsen, Kaj K.
• Application Number:
  US09/518,075
• Publication Number:
  US 20020130042A1
• Time in Patent Office: 1,475 Days
• Field of Search: 204/403, 204/403.01, 204/403.02, 204/403.03, 204/403.04, 204/403.05, 600/584, 600/576, 600/583, 606/181, 606/182, 606/184, 606/185, 606/167
• US Class Current: 204/403.03
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150503 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An apparatus for detection and quantitation of an electrochemically-detectable analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid. In one version, the lancet moves from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position. The electrochemical sensor is disposed such that the absorptive member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus. In an alternative version, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. In either version, the apparatus provides single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing the apparatus against the users skin.

Claims

1. An apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid, comprising:

a plurality of electrochemical sensors;

an equal plurality of cutting members wherein the plurality of electrochemical sensors are provided on a disk;

a meter unit comprising a housing, means disposed within the housing for engaging one of the cutting members and moving the engaged cutting member, a connector disposed within the housing for engaging one of the electrochemical sensors specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to a user;

wherein

the cutting member is engaged within the housing; and

the electrochemical sensor comprises an absorptive member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial position to a piercing position in which skin of the user is pierced, the electrochemical sensor being disposed such that the means for engaging and moving the cutting member causes the cutting member to pierce the sensor prior to piercing the skin of the user;

the absorptive member taking up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus.

2. The apparatus of claim 1, wherein the housing is a flattened disk having a top and a bottom surface, and further comprising a strap for holding the bottom surface of the housing against the skin of a user, wherein the electrochemical sensors are disposed adjacent to the bottom surface and the cutting members move to pierce the skin adjacent to the bottom surface.

3. The apparatus of claim 2, wherein the display is visible to the user when the bottom surface is held against the skin of the user.

4. The apparatus of claim 2, further comprising a timer operatively connected to the plurality of cutting members for automatically taking and evaluating a sample at predefined time intervals.

5. The apparatus of claim 4, wherein the time intervals are adjusted in response to amounts of analyte as determined by the apparatus.

6. The apparatus of claim 4, further comprising an alarm for indicating to the user that sufficient sample has been collected.

7. The apparatus of claim 6, further comprising an alarm for indicating to the user that it is time to take a sample.

8. The apparatus of claim 2, further comprising an alarm for indicating measured levels of analyte which are above or below preestablished thresholds.

9. The apparatus of claim 8, wherein the alarm transmits a signal to a remote receiver.

10. An apparatus for detection and quantitation of an electrochemically-detectable analyte in blood or interstitial fluid, comprising:

a plurality of electrochemical sensors;

a meter unit comprising a housing, means disposed within the housing for engaging a cutting member and moving the engaged cutting member, a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal from the sensor indicative of the amount of analyte, and a display operatively-associated with the connector for displaying the amount of the analyte to user;

wherein

the cutting member is engaged within the housing;

the electrochemical sensor comprises an absorptive member for the uptake of a sample of blood or interstitial fluid, wherein the means for engaging and moving the cutting member moves the cutting member in a cycle from an initial position to a piercing position in which skin of the user is pierced, and wherein the electrochemical sensor is disposed such that the absorptive member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus;

the cutting member is a hollow cannula having a proximal end and a distal end, and wherein the proximal end is in juxtaposition with the electrochemical sensor to permit absorption of fluid passing through the hollow cannula by the absorptive member; and

the plurality of electrochemical sensors are provided on a disk.