Integrated sample testing meter

• US 20030191415A1
• Filed: 04/29/2003
• Published: 10/09/2003
• Est. Priority Date: 03/29/2001
• Status: Abandoned Application

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Shaanan, Gad, Mainville, Patrick, Bode, Andreas, Orban, Benoit, Coley, Benjamin, Francpvich, Walter, Moerman, Piet, Stiene, Matthias, Griffith, Alun
• Application Number:
  US10/297,006
• Publication Number:
  US 20030191415A1
• Time in Patent Office: Days
• US Class Current: 600/584
• 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 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack

Abstract

An integrated sample testing meter, for instance for measuring blood, comprising a lancing device, an electrochemical sensor and a test strip cartridge disposed in a single modular housing. The test strip cartridge includes a stack of test strips suitable for performing an electrochemical or photometric analysis of a blood sample. The integrated test system automatically dispenses and positions a test strip in proximity to a lancet puncture site, automatically transfer, a blood sample to the test strip from the lancet puncture site and automatically analyzes the blood sample after the test strip collects the sample from the puncture site.

Claims

1. An integrated sample-testing meter comprising a single modular housing carrying:

a pressure device;

a lancet;

a lancet drive train for driving the lancet between an extended position and a retracted position;

a test strip cartridge containing a plurality of test strips, each strip having a sample-receiving area;

a sensor for analyzing a fluid sample received on a test strip; and

a test strip dispensing system for moving test strips individually from the cartridge to a sample-receiving position in which the sample-receiving area of the test strip is in proximity to the location of the end of the lancet in its extended position and in which the test strip is connected to the sensor,

the meter being arranged such that, in use, when it is located on the skin of a user and is activated, the lancet is moved to its extended position and retracted to form a puncture in the user'"'"'s skin, the pressure device causes a drop of fluid to form around the puncture, a test strip is moved from the cartridge to the sample-receiving position, the test strip receives a sample from the fluid drop and the sensor analyzes the sample.

2. The meter of claim 1, which includes electrical or electronic circuitry for controlling its operation.

3. The meter of claim 2, wherein the circuitry also includes a visual display unit.

4. The meter of claim 2 or claim 3, wherein the circuitry includes means for entering data into the meter.

5. The meter of claim 4, wherein the data entry means comprises a touch sensitive display, a microphone and voice activated software or control buttons.

6. The meter of any one of claims 1 to 5, which is arranged such that, in use, when a strip is in the sample-receiving position, its sample-receiving area is spaced from the puncture site by a distance of from about 0.4 mm to about 1.3 mm.

7. The meter of claim 6, wherein the distance is from about 0.7 mm to about 0.9 mm.

8. The meter of any one of claims 1 to 7, wherein the pressure device comprises a pressure ring arranged to be located, in use, on the user'"'"'s skin and to apply pressure at the edges of the ring to increase the amount of fluid available at the centre of the ring.

9. The meter of claim 8, wherein the pressure ring is shaped to conform to the shape of the area of the skin to which it is to be applied.

10. The meter of claim 8 or claim 9, wherein the pressure ring has a multi-contoured surface to increase the pressure gradient from the outside to the inside of the ring.

11. The meter of any one of claims 8 to 10, wherein the pressure ring is part of a lancet cap which covers the lancet in its retracted position.

12. The meter of any one of claims 1 to 10, which includes a lancet cap.

13. The meter of claim 11 or claim 12, wherein the lancet cap includes a means which co-operates with the lancet drive train to ensure that the lancet travels along approximately the same path on each activation of the drive train.

14. The meter of claim 13, wherein the means comprises a side wall.

15. The meter of any one of claims 11 to 14, wherein the lancet cap is an integral part of the housing.

16. The meter of any one of claims 11 to 14, wherein the lancet cap is detachably mounted on the housing.

17. The meter of claim 16, wherein the lancet cap is detachably mounted on the housing by use of screw-thread or bayonet type fixings or by use of a snap fit connection.

18. The meter of claim 16 or claim 17, which includes at least two interchangeable lancet caps.

19. The meter of any one of claims 1 to 18, wherein the lancet is removably attached to the lancet drive train.

20. The meter of any one of claims 1 to 19, wherein the lancet drive train is spring driven.

21. The meter of any one of claims 1 to 20, wherein the lancet drive train includes an adjustment screw which allows the user to set the extended position of the lancet.

22. The meter of claim 21, wherein the operation of the adjustment screw is arranged such that the distance of travel of the lancet remains constant.

23. The meter of any one of claims 1 to 22, wherein the lancet drive train is arranged such that the end of the lancet, in its extended position, extends to approximately the plane formed by the pressure ring or aperture in the housing which, in use, is placed on the user'"'"'s skin.

24. The meter of any one of claims 1 to 23, wherein the test strip cartridge comprises a cartridge housing defining a cavity configured to receive a stack of test strips, a partially detachable cartridge cap and a means for moving the stack of test strips towards the cartridge cap.

25. The meter of claim 24, wherein the cartridge includes a seal for sealing the cartridge cap to the cartridge housing when the cartridge cap is fully engaged with the cartridge housing.

26. The meter of claim 24 or claim 25, wherein the cartridge is manufactured from a material having dessicant properties.

27. The meter of any one of claims 1 to 26, wherein the cartridge has on it data relating to the calibration code for the strips in the cartridge.

28. The meter of claim 27, wherein the data also include data selected from a unique number identifying the specific cartridge, the number of strips originally present in the cartridge, the expiry date for the cartridge, different calibration factors for different sources of fluid (neonatal, arterial or venous blood, for instance), control solution range information and any other relevant information to assist in operation of the meter.

29. The meter of claim 27 or claim 28, wherein the data are present as visually readable indicia and the meter includes means to allow the user to enter data into the meter.

30. The meter of claim 27 or claim 28, wherein the data on the cartridge are present in machine-readable format.

31. The meter of claim 30, wherein the data are present as a bar code or a resistance bridge circuit.

32. The meter of claim 30, wherein the data are or stored in an electronic memory module.

33. The meter of claim 32, wherein the electronic memory module comprises a rewritable memory and the meter is arranged to write back into the memory module.

34. The meter of any one of claims 1 to 33, wherein the test strip dispensing system includes a slider adapted to engage with only one of the test strips in the cartridge and move it to the sample-receiving position.

35. The meter of any one of claims 1 to 33, which includes a feeding channel which receives the strip from the cartridge and guides it to the sample-receiving position.

36. The meter of claim 35, wherein the feeding channel includes a step arranged such, when the strip has been moved past the step, the strip drops, or is forced, into the step, thereby preventing the strip from moving back towards the cartridge.

37. The meter of claim 36, wherein the strip is forced into the step by springs located on the meter.

38. The meter of claim 37, wherein the springs are electrically conductive and are arranged to make electrical contact with electrodes or a conductive bar on the strip.

39. The meter of any one of claims 35 to 38, wherein the feeding channel is arranged such that the major plane of the strip, when in the sample-receiving position, is at an angle of from about 30°

to about 60°

to the direction of movement of the lancet towards its extended position.

40. The meter of claim 39, wherein the feeding channel is arranged such that the major plane of the strip, when in the sample-receiving position, is at an angle of about 45°

to the direction of movement of the lancet towards its extended position.

41. The meter of any one of claims 1 to 40, which includes an ejection means for ejecting a used test strip from the meter once a test has been completed.

42. The meter of claim 41 when dependent on claim 11 or claim 12 or any claim dependent thereon, wherein the ejection means is operated as the cartridge cap is closed.

43. The meter of any one of claims 1 to 42, which includes a deviator which prevents the test strip dispensing system moving a further test strip into the sample-receiving position while a first test strip is still in position.

44. The meter of claim 43 when dependent on claim 11 or claim 12 or any claim dependent thereon, wherein the deviator operates in conjunction with the cartridge cap.

45. The meter of any one of claims 1 to 44, which includes a means for verifying that a strip is in the sample-receiving position.

46. The meter of claim 45, which is adapted to carry out electrochemical measurements and the verifying means includes electrodes on the meter which contact the electrodes on the strip.

47. The meter of claim 45 or claim 46, wherein the verifying means is also used to activate fully the circuitry in the meter.

48. The meter of any one of claims 45 to 47, wherein the verifying means is also arranged to start a timer in the circuitry of the meter and the timer is stopped by the ejection of a used strip from the meter.

49. The meter of claim 48, wherein the circuitry is arranged to sum the total time that the cartridge has been open and to produce a warning signal if the total exceeds a pre-set maximum.

50. The meter of any one of claims 1 to 49, which includes circuitry which counts the number of strips dispensed from each cartridge.

51. The meter of any one of claims 1 to 50, which is activated manually by use of a single movement.

52. The meter of claim 51, which is activated manually by use of a single movement of a multi-functional handle assembly carried by the housing.

53. The meter of claim 52, wherein the actuation of the handle assembly cocks the lancet drive train and moves a single test strip into the sample-receiving position.

54. The meter of any one of claims 1 to 53, wherein the lancet drive train is fired by actuation of a trigger.

55. The meter of any one of claims 1 to 54, which is adapted to produce and analyze a sample of blood for glucose levels.

56. The meter of claim 55, wherein the strips are adapted to carry out electrochemical analyses and the circuitry in the meter is arranged to contact the electrodes in such strips.

57. A disposable test strip cartridge adapted to be loaded into the meter of any one of claims 1 to 56, the cartridge including a cartridge housing defining a cavity configured to receive a stack of test strips, a partially detachable cartridge cap and a stack of test strips disposed in the cavity.

58. The test strip cartridge of claim 57, further comprising a push-up mechanism for pushing said stack of test strips in the direction of the cartridge cap.

59. The test strip cartridge of claim 58, wherein the push-up mechanism comprises a constant-force spring and a loader contacting said stack of test strips.

60. The test strip cartridge of any one of claims 57 to 59, wherein the cartridge is adapted to dispense strips on a one-by-one basis.

61. A multi-function handle assembly for the meter of any one of claims 1 to 56.

62. The multi-function handle assembly of claim 61, which comprises a lever.

63. A strip dispensing system for forwarding test strips from a test strip cartridge to the sample-receiving position in the meter of any one of claims 1 to 56 on a one-by-one basis, the strip dispensing system including a slider for pushing a test strip from the cartridge to a feeding channel and a deviator for preventing a plurality of test strips from being positioned in the feeding channel at one time.

64. The system of claim 63, wherein the deviator diverts the slider inside the test cartridge cap when a test strip is positioned in the feeding channel.

65. An integrated method of sampling and testing a sample of a bodily fluid comprising loading a test strip cartridge into an integrated testing meter of any one of claims 1 to 56, depressing a handle assembly on the testing meter to cock a lancing device and push a test strip into a sample-receiving position, pressing the integrated testing meter on the skin of a user and pressing a trigger of the testing meter to drive a lancet into the skin in order to form a drop of blood or other fluid on the skin surface, which drop is absorbed by the strip and an automated analysis of the sample by the integrated testing meter is carried out.