Combined lancet and electrochemical analyte-testing apparatus

• US 20020130042A1
• Filed: 03/02/2000
• Published: 09/19/2002
• Est. Priority Date: 03/02/2000
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Diabetes Diagnostics, Inc. (Johnson & Johnson)
• Inventors: Moerman, Piet H.C., Stiene, Matthias, McAleer, Jerome F.
• Granted Patent: US 6,706,159 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• 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) a meter unit comprising a housing, means disposed within the housing for engaging a cutting member and moving an 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;

(b) a cutting member engaged within the housing;

(c) an electrochemical sensor comprising 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.

2. The apparatus of claim 1, wherein the electrochemical sensor and the cutting member are 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.

3. The apparatus of claim 2, wherein the means for moving the cutting member moves the cutting member back to a retracted position which may be the same or different from the first retracted position after piercing the skin of the user.

4. The apparatus of claim 2, further comprising a skin-contact ring disposed to apply pressure to an area surrounding the piercing of the skin when the apparatus is pressed against the skin of the user.

5. The apparatus of claim 2, further comprising a vacuum mechanism disposed within the housing to accelerate extraction of sample after piercing when the apparatus is pressed against the skin of the user.

6. The apparatus of claim 2, comprising a plurality of electrochemical sensors and an equal plurality of cutting members.

7. The apparatus of claim 6, wherein the plurality of electrochemical sensors are provided on a disk.

8. The apparatus of claim 7, 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.

9. The apparatus of claim 8, wherein the display is visible to the user when the bottom surface is held against the skin of the user.

10. The apparatus of claim 8, further comprising a timer operatively connected to the plurality of cutting members for automatically taking and evaluating a sample at pre-defined time intervals.

11. The apparatus of claim 10, wherein the time intervals are adjusted in response to amounts of analyte as determined by the apparatus.

12. The apparatus of claim 10, further comprising an alarm for indicating to the user that sufficient sample has been collected.

13. The apparatus of claim 12, further comprising an alarm for indicating to the user that it is time to take a sample.

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

15. The apparatus of claim 14, wherein the alarm transmits a signal to a remote receiver.

16. The apparatus of claim 5, further comprising a timer operatively connected to the plurality of cutting members for automatically taking and evaluating a sample at pre-defined time intervals.

17. The apparatus of claim 16, wherein the time intervals are adjusted in response to amounts of analyte as determined by the apparatus.

18. The apparatus of claim 16, further comprising an alarm for indicating to the user that sufficient sample has been collected.

19. The apparatus of claim 16, further comprising an alarm for indicating to the user that it is time to take a sample.

20. The apparatus of claim 16, further comprising an alarm for indicating measured levels of analyte which are above or below preestablished thresholds.

21. The apparatus of claim 20, wherein the alarm transmits a signal to a remote receiver.

22. The apparatus of claim 2, further comprising an alarm for indicating to the user that sufficient sample has been collected.

23. The apparatus of claim 2, further comprising an alarm for indicating to the user that it is time to take a sample.

24. The apparatus of claim 23, wherein intervals between activation of the alarm are adjusted in response to amounts of analyte as determined by the apparatus.

25. The apparatus of claim 2, further comprising a skin-contact ring disposed to apply pressure to an area surrounding the piercing of the skin when the apparatus is pressed against the skin of the user.

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

27. The apparatus of claim 26, wherein the alarm transmits a signal to a remote receiver.

28. The apparatus of claim 1, further comprising an alarm for indicating to the user that sufficient sample has been collected.

29. The apparatus of claim 1, further comprising an alarm for indicating to the user that it is time to take a sample.

30. The apparatus of claim 29, wherein intervals between activation of the alarm are adjusted in response to amounts of analyte as determined by the apparatus.

31. The apparatus of claim 1, further comprising an alarm for indicating measured levels of analyte which are above or below preestablished thresholds.

32. The apparatus of claim 31, wherein the alarm transmits a signal to a remote receiver.

33. The apparatus of claim 1, wherein 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.

34. The apparatus of claim 33, further comprising a skin-contact ring disposed to apply pressure to an area surrounding the piercing of the skin when the apparatus is pressed against the skin of the user.

35. The apparatus of claim 34, wherein the means for moving the cutting member moves the cutting member back to a retracted position which may be the same or different from the first retracted position after piercing the skin of the user.

36. The apparatus of claim 35, further comprising a skin-contact ring disposed to apply pressure to an area surrounding the piercing of the skin when the apparatus is pressed against the skin of the user.

37. The apparatus of claim 33, comprising a plurality of electrochemical sensors.

38. The apparatus of claim 37, wherein the plurality of electrochemical sensors are provided on a disk.

40. The sensor assembly of claim 1, wherein the sensor is disposed between the skin contact ring and the collar member, and wherein the collar member further comprising an electrical connector in contact with the electrical contact portion of the electrochemical sensor for transmitted an electrical signal from the electrical contact to an electrical contact in a meter unit received within the collar member.

39. A sensor assembly for electrochemical detection of an analyte when associated with a meter unit, said assembly comprising a collar member, a skin-contact ring and an electrochemical sensor, wherein

the skin-contact ring comprises a wall member having a central opening with first and second open ends formed therethrough,

the electrochemical sensor is disposed adjacent to the skin-contact ring and extends across the first open end of the skin-contact ring, said sensor comprising reagents for generation of an electrochemical signal in response to the presence of analyte and an adsorptive member for absorbing fluid placed within the central opening of the ring and transporting the fluid into reactive proximity to the reagents, and an electrical contact for transmitting the electrochemical signal from the sensor;

and

the collar member comprises a wall member having a central opening for receiving a portion of the meter unit and holding it in position with respect to the electrochemical sensor and the skin-contacting portion.

41. A sensor assembly for electrochemical detection of an analyte when associated with a meter unit, said assembly comprising a housing formed from a collar portion and a base portion, a cutting member in the form of a hollow tube and an electrochemical sensor, wherein

the electrochemical sensor is disposed in contact with a first surface of the base portion, said sensor comprising reagents for generation of an electrochemical signal in response to the presence of analyte and an adsorptive member for absorbing and transporting fluid into reactive proximity to the reagents, and an electrical contact for transmitting the electrochemical signal from the sensor;

the cutting member passes through the base portion thereby forming a channel for passage of fluid between the electrochemical sensor disposed in contact with the first surface of the base portion and a second opposed surface of the base portion, and

the collar portion comprises a wall member having a central opening for receiving a portion of the meter unit and an electrical connector in contact with the electrical contact of the sensor for transmitting an electrical signal from the electrical contact to an electrical contact in the meter.