Devices and Methods for Accessing and Analyzing Physiological Fluid

• US 20080009768A1
• Filed: 09/20/2007
• Published: 01/10/2008
• Est. Priority Date: 05/09/2002
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: SOHRAB, Borzu
• Application Number:
  US11/858,642
• Publication Number:
  US 20080009768A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• 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 5/15126 Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15159 Piercing elements stocked in or on a disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Systems, devices and methods for determining the concentration of physiological fluid analytes are provided. The subject systems have a plurality of biosensor devices present on a disposable cartridge. Each biosensor device includes a biosensor and a skin penetration means. In practicing the subject methods, a movement means of the device is used to move each biosensor device in a first direction that provides for penetration of the skin-piercing means into a skin layer followed by movement of the biosensor in a second direction that provides for removal of the skin-piercing means from the skin layer, where this movement profile provides for physiological fluid access and analyte concentration determination by the analyte sensor means. The subject systems, devices and methods for using the same find use in determining the concentration of a variety of different physiological fluid analytes, and are particularly suited for use in detection of physiological fluid glucose concentration.

Claims

1. A system comprising:

a housing including a plurality of devices, each device comprising;

(i) a skin-piercing member configured to access physiological fluid beneath a skin surface;

(ii) a biosensor configured to measure a characteristic of the accessed physiological fluid, the skin-piercing member being integrated with the biosensor via a physiological fluid transfer pathway; and

the housing having a ramped surface and an advancing member configured to move each device so that the skin-piercing member cooperates with the ramped surface to deflect the skin-piercing member and penetrate the skin surface at an oblique angle relative to the skin surface.

2. The system according to claim 1, wherein each device comprises a planar configuration wherein the skin-piercing member extends therefrom.

3. The system according to claim 2, wherein the skin-piercing member extends substantially within a same plane as the planar configuration.

4. The system according to claim 3, wherein each device defines a biosensor having a test strip configuration and the skin-piercing member extends from the biosensor.

5. The system according to claim 2, wherein the skin-piercing member extends in a direction substantially transverse to the device.

6. The system according to claim 5, wherein each device defines a frame having a biosensor portion and a skin-piercing portion spaced apart from each other.

7. The system according to claim 1 wherein each device comprises an angled configuration having a distal end defining the skin-piercing member and a proximal end defining the biosensor.

26. The system according to claim 1, wherein the plurality of devices is provided in a cartridge, the cartridge comprising a frame and a plurality of torsion bars attached to the frame, wherein each device is operatively attached to a torsion bar.

27. The system according to claim 26, wherein each torsion bar allows the device to be movable relative to the frame.

28. The system according to claim 27, wherein each torsion bar allows the device to rotate at least partially about an axis defined by the torsion bar.

29. The system according to claim 28, wherein the axis of rotation is perpendicular to a path along which the cartridge is caused to travel.

30. The system according to claim 26, wherein the cartridge comprises a disk configuration and wherein a serial arrangement of the plurality of devices is about a circumference of the cartridge.

8-9. -9. (canceled)

10. A system comprising:

a housing, the housing having a skin-facing portion;

an aperture within the skin-facing portion;

a cartridge receivable within the housing, the cartridge comprising a plurality of devices, each device comprising;

(i) a skin-piercing member configured to access physiological fluid beneath a skin surface;

(ii) a biosensor configured to measure a characteristic of the accessed physiological fluid, the skin-piercing member being integrated with the biosensor via a physiological fluid transfer pathway;

the housing further comprising a ramped surface;

an advancing member configured to move each device so that the skin-piercing member cooperates with the ramped surface to deflect the skin-piercing member towards the aperture and pierce the skin surface; and

a meter disposed within the housing, the meter configured to measure a characteristic of the physiological fluid by applying a signal to the biosensor and receiving a resulting signal from the biosensor.

16. The system according to claim 10, wherein the advancing member is configured to move each device relative to the aperture in a forward and a reverse direction.

17. The system according to claim 10, wherein the advancing member is configured to rotate the cartridge.

18. The system according to claim 10, wherein a motor is configured to move the advancing member.

11-15. -15. (canceled)

19-25. -25. (canceled)

31-36. -36. (canceled)

37. A method for accessing a physiological fluid sample of a host and measuring the concentration of an analyte within the physiological fluid, comprising:

(a) providing a cartridge in planar apposition to a skin surface of the host, the cartridge comprising a plurality of devices;

(b) moving the cartridge in a first direction, thereby causing an advancing member to cause a skin-piercing member to penetrate a skin surface at an oblique angle relative to the skin surface

(c) transferring the physiological fluid from the skin-piercing member to the biosensor via a physiological fluid pathway; and

(d) moving the cartridge in a second direction to cause the advancing member to retract the skin-piercing member from the skin surface.

38. The method according to claim 37, further comprising repeating steps (b), (c) and (d) for each device of the plurality of devices.

39. The method according to claim 38, wherein the step of repeating occurs according to a predefined time schedule.

40. A method for accessing a physiological fluid of a host, comprising

(a) providing a system including

a housing having a skin-facing portion;

an aperture within the skin-facing portion;

a cartridge receivable within the housing, the cartridge comprising a plurality of devices, each device comprising;

(i) a skin-piercing member configured to access physiological fluid beneath a skin surface;

(ii) a biosensor configured to measure a characteristic of the accessed physiological fluid, the skin-piercing member being integrated with the biosensor via a physiological fluid transfer pathway;

the housing further comprising a ramped surface;

an advancing member configured to move each device so that the skin-piercing member cooperates with the ramped surface to deflect the skin-piercing member towards the aperture and pierce the skin surface; and

a meter disposed within the housing, the meter configured to measure a characteristic of the physiological fluid by applying a signal to the biosensor and receiving a resulting signal from the biosensor,

wherein the skin-facing portion of the housing is in contact with a section of a skin surface;

(b) moving the cartridge in a first direction to cause an advancing member to permit the skin-piercing member to move towards the aperture in the housing and penetrate the skin surface;

(c) transferring the physiological fluid from the skin-piercing member to the biosensor via the physiological fluid pathway; and

(d) moving the cartridge in a second direction to cause the advancing member to retract the skin-piercing member from the skin surface.

41. The method according to claim 40, further comprising repeating steps (b), (c), and (d) for each device of the plurality of devices.

42. The method according to claim 40, further comprising the step of measuring the analyte concentration.

43. The method according to claim 42, further comprising the step of displaying the analyte concentration following the measurement step.

44. The method according to claim 41, wherein the step of repeating occurs according to a predefined time schedule.

45-50. -50. (canceled)

51. A system comprising:

a housing, the housing including

a skin-facing portion and

an aperture within the skin-facing portion;

a cartridge receivable within the housing, the housing including a plurality of devices, each device comprising;

(i) a skin-piercing member configured to access physiological fluid beneath a skin surface;

(ii) a biosensor configured to measure a characteristic of the accessed physiological fluid, the skin-piercing member being integrated with the biosensor via a physiological fluid transfer pathway;

an advancing member configured to move the cartridge within the housing so that each device is positioned relative to an aperture, the advancing member having a clip configured to hold the biosensor; and

a meter disposed within the housing, the meter configured to measure a characteristic of the physiological fluid by applying a signal to the biosensor and receiving a resulting signal from the biosensor.