Body fluid sampling device

• US 8,162,854 B2
• Filed: 09/05/2006
• Issued: 04/24/2012
• Est. Priority Date: 03/06/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Calasso, Irio G., Griss, Patrick, Jaeggi, Rainer, Sarofim, Emad
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/470,021
• Publication Number:
  US 20070038149A1
• Time in Patent Office: 2,058 Days
• Field of Search: 600/583, 600/584
• US Class Current: 600/584
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150435 Specific design of proximal end
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap

Abstract

Body fluid sampling device comprising a skin-piercing element (10) having a fluid pathway (11) for receiving body fluid, at least a portion of the fluid pathway is open to the environment and further comprising a fluid receiving element (40) being spaced from the fluid pathway so that fluid in the pathway will not contact the fluid receiving element initially. The fluid receiving element may have a test zone (45) for performing an analytical reaction. Fluid from the channel is contacted with the fluid receiving element either by bringing the fluid receiving element and the fluid into mechanical contact or by electrically transporting fluid from the channel onto the fluid receiving element.

Claims

1. A device for sampling body fluid, comprising:

a fluid pathway for receiving body fluid in a first state, wherein said fluid pathway along its longitudinal extension is open to the environment,

a skin piercing element having said fluid pathway,

a fluid receiving means being separately spaced apart from said fluid pathway so that body fluid in said pathway is out of fluidic contact with the fluid receiving means in the first separated state,

the device being adapted to undergo a physical change upon actuation after body fluid is received in said fluid pathway so as to assume a second contacting state in which body fluid in said fluid pathway contacts said fluid receiving means, and

wherein said device having a moveable portion which can be moved and at least a portion of said fluid pathway or fluid receiving means is located on said moveable portion to assume the contacting state.

3. The device according to claim 1, wherein the fluid receiving means comprises a test zone.

4. The device according to claim 1, wherein the fluid receiving means is separated from the fluid pathway by an air gap.

5. The device according to claim 4, wherein the air gap is maintained by spacer.

6. The device according to claim 1, wherein said skin piercing element has a fluid transfer region and at least a portion of said fluid pathway in said fluid transfer region has pointed walls.

7. The device according to claim 6, wherein said fluid receiving means comprises a layer structure that can be depressed or cut by said pointed walls.

8. The device according to claim 1, wherein body fluid received in said fluid pathway is moved by electrical actuation onto the fluid receiving means.

10. The device according to claim 1, wherein the fluid pathway or the fluid receiving means have confining means for confining the area of fluid transfer from the fluid pathway onto the fluid receiving means.

11. The device according to claim 1, wherein said fluid pathway has protruding wall portions and a surface adjacent to the fluid pathway is recessed with respect to the protruding wall portions.

12. The device according to claim 1, wherein a surface adjacent to the fluid pathway is hydrophobic.

13. The device according to claim 1, wherein said fluid receiving means comprises a test zone and at least one of a reaction zone, a filtration zone and a mixing zone.

14. The device according to claim 1, wherein said skin-piercing element has two or more fluid pathways.

15. The device according to claim 1, wherein said fluid pathway in a first region has a first width and in another region has a second width which is smaller than the first width.

16. The device according to claim 15, wherein said fluid pathway further comprises a collecting zone.

17. The device according to claim 13, wherein said test zone is located in or contacted with an intermediate portion of the fluid pathway so that the fluid portion entering the pathway first is not contacted with the test zone.

18. The device according to claim 1, wherein the fluid pathway has a sampling section and at least one discharge section located downstream the sampling section and/or branching off upstream the sampling section for receiving a fraction of the body fluid entering the pathway first, and wherein the sampling section is a test zone or can be contacted with a test zone for analysis of body fluid contained therein.

2. A device for sampling body fluid, comprising:

a fluid pathway for receiving body fluid in a first state, wherein said fluid pathway along its longitudinal extension is open to the environment and

a fluid receiving means being separately spaced apart from said fluid pathway by an air gap so that body fluid in said pathway is out of fluidic contact with the fluid receiving means in the first separated state, and

the device being adapted to undergo a physical change upon actuation after body fluid is received in said fluid pathway so as to assume a second contacting state in which body fluid in said fluid pathway contacts said fluid receiving means.

9. The device according to claim 2, wherein the skin piercing element has a collection zone in which upstanding elements are located.

19. A device for body fluid analysis, comprising:

a skin piercing element with a fluid pathway for receiving body fluid, wherein said fluid pathway along its longitudinal extension is open to the environment; and

a fluid receiving means being physically spaced from said fluid pathway so that fluid in said pathway is out of fluidic contact with the fluid receiving means in a first condition, and said fluid receiving means physically contacting said fluid pathway after body fluid is received in said fluid pathway so that fluid in said fluid pathway is in fluidic contact with the fluid receiving means in a second condition,

said fluid receiving means comprising a test zone.

20. The device according to claim 19, comprising a meter with a detection unit for receiving signals from said test zone to determine the presence and/or concentration of an analyte.

21. The device according to claim 20, wherein said meter includes a holder in which said fluid receiving means is received and signal transmission from the test zone to the detector is enabled.

22. The device according to claim 19, comprising a contacting means which brings a portion of the fluid pathway into physical contact with the fluid receiving means to provide the test zone with sample fluid.

23. The device according to claim 21, wherein said meter has a processing unit that receives a signal indicating that the contacting means has contacted the fluid pathway with the fluid receiving means or that sample fluid has reached the test zone.

24. The device according to claim 22, wherein said contacting means comprises voltage means for applying an electrical potential between said fluid pathway and said fluid receiving means so that fluid from the fluid pathway contacts the fluid receiving means.

25. The device according to claim 22, wherein said contacting means applies a force to a moveable portion of the fluid pathway or the fluid receiving means to bring the fluid pathway and the fluid receiving means into mutual contact.

26. The device according to claim 19, comprising a magnetic contacting means for applying a magnetic field to bring the fluid pathway and the fluid receiving means into fluid transferring contact.

27. The device according to claim 26, wherein the magnetic contacting means includes a permanent magnet, an electromagnet, a solenoid or a current carrying wire.

28. The device according to claim 26, wherein at least one of a paramagnetic or ferromagnetic material or a current carrying element or a preferably ring-like element for producing a magnetic dipole moment under time-varying magnetic fields is incorporated or attached to a portion of the fluid pathway and/or of the fluid receiving means.

29. The device according to claim 22, wherein the contacting means has an optical matching element for coupling the test zone to an optical detection unit, the optical matching element being adapted for exerting a mechanical force to bring the fluid pathway and the fluid receiving means into a contacting state.

30. The device according to claim 29, wherein the optical detection unit includes a reflectometer connected to the optical matching element via an optics comprising lenses, optical waveguides and/or optical fibres.

31. The device according to claim 29, wherein the optical matching element is provided by a coating of the optics facing the test zone.

32. The device according to claim 29, wherein the optical matching element has a refractive index matched to the refractive index of the test zone.

33. The device according to claim 29, wherein the optical matching element consists of an elastomeric material.

34. The device according to claim 29, wherein the optical matching element is arranged on a side of the test zone opposite to the fluid pathway and is designed preferably as a lever arm or ram for the transduction of mechanical displacement to assume a contacting state between the fluid pathway and the test zone.

35. The device according to claim 19, comprising a drive means for driving the skin piercing element into skin to pierce the skin for obtaining a body fluid sample.

36. A system for body fluid analysis, comprising:

a skin-piercing element with a fluid pathway for receiving body fluid, wherein said fluid pathway along its longitudinal extension is open to the environment,

a fluid receiving means being spaced from said fluid pathway so that fluid in said pathway will not contact the fluid receiving means, said fluid receiving means comprising a test zone, and

a transport means to transport the skin piercing element into contact with the fluid receiving means after body fluid is received in the fluid pathway.

37. The system according to claim 36, further comprising:

a magazine storing multiple fluid receiving means.

38. The system according to claim 37, further comprising:

an exposing unit for successively exposing fluid receiving means from said magazine to receive fluid.

39. A device for sampling body fluid, comprising:

a skin piercing element with a capillary channel for receiving body fluid, wherein the channel is open along its longitudinal extension, and wherein the channel has a sampling section and at least one discharge section located downstream the sampling section and/or branching off upstream the sampling section for receiving and discharging a fraction of the body fluid entering the capillary first, and

wherein the sampling section is a test zone or is contacted with a test zone after body fluid is received in the capillary channel for analysis of body fluid contained therein.

40. The device according to claim 39, wherein the sampling section is filled through an inlet section of the capillary channel, the capillarity of the inlet section being smaller than the capillarity of the at least one discharge section branching off the inlet section.

41. The device according to claim 39, wherein the capillarity of the discharge section is increased by means of a lid closing an open side portion of the discharge section.

42. The device according to claim 39, wherein the discharge section has a waste region and a reservoir region upstream of the waste region, and wherein body fluid from the reservoir region is fed to the sampling section after an uptake phase.

43. The device according to claim 39, wherein the capillarity of the sampling section is increased through contact of a fluid receiving means after filling of the discharge section.

44. The device according to claim 39, wherein the volume of the discharge section is larger than the volume of the sampling section.

45. A method for determining an analyte concentration in body fluid comprising the steps of:

a) receiving body fluid in a fluid pathway preferably of a skin piercing element, the fluid pathway being physically separated from a fluid receiving means during filling,

b) physically contacting the fluid pathway with the fluid receiving means after body fluid is received in the fluid pathway so that body fluid from the fluid pathway contacts the fluid receiving means and reaches a test zone,

c) receiving signals from said test zone which are characteristic for an analyte concentration, and

d) processing said signals to determine the analyte concentration.

46. The method according to claim 45, wherein a time period beginning with step b) is monitored and determination of analyte concentration is initiated based on the time passed.

47. The method according to claim 45, wherein step b) initiates a monitoring of signals and the change of signal over time is employed to determine a point in time for concentration determination.

48. The method according to claim 45, comprising pricking skin with said skin piercing element.

49. The method according to claim 45, wherein the fluid receiving means includes the test zone.

50. The method according to claim 45, wherein the fluid pathway includes a support structure and the fluid receiving means includes a support structure, and wherein the fluid pathway support structure is connected to the fluid receiving means support structure.

51. A device for body fluid analysis, comprising:

a skin piercing element including

a holder frame, and

an elongated portion including

a protruding portion having a front end region with a sharpened tip protruding from the holder frame,

a moveable portion located in the holder frame, wherein the moveable portion is shaped in a form of a tongue to promote bending of the moveable portion, and

a fluid pathway being open to the environment along the elongated portion from the front end region of the protruding portion to the moveable portion;

a fluid receiving element spaced away from the fluid pathway so that a body fluid sample within the fluid pathway does not contact the fluid receiving element, the fluid receiving element including

a holding structure spacing the fluid receiving element from the fluid pathway of the skin piercing element, and

a test zone containing reagent chemistry for analyzing the body fluid sample; and

the moveable portion being bendable relative to the holder frame from a first state where the fluid pathway does not contact the fluid receiving element to a second state where the fluid pathway contacts the fluid receiving element to wet the test zone with the body fluid sample.

52. The device of claim 51, further comprising:

the fluid pathway at the moveable portion having an end section located opposite the front end region and an intermediate section located between the front end region and the end section; and

the test zone being located to contact the intermediate section and not the end section of the fluid pathway when the moveable portion is bent to reduce contamination of the test zone.

53. A method, comprising:

piercing skin with a sharpened end of a skin piercing element, wherein the skin piercing element includes a holder frame, and an elongated portion, wherein the elongated portion includes a protruding portion having a front end region with the sharpened tip protruding from the holder frame, a moveable portion located in the holder frame, and a fluid pathway that is open to the environment along the elongated portion from the front end region of the protruding portion to the moveable portion;

filling the fluid pathway with body fluid from the skin while a fluid receiving element is spaced away from the fluid pathway so that the body fluid within the fluid pathway does not contact the fluid receiving element, wherein the fluid receiving element includes a test zone containing reagent chemistry; and

after said filling the fluid pathway, bending the moveable portion relative to the holder frame to a position where the fluid pathway contacts the fluid receiving element to wet the test zone with the body fluid.

54. The method of claim 53, further comprising:

wherein the fluid pathway at the moveable portion has an end section located opposite the front end region and an intermediate section located between the front end region and the end section; and

wherein said bending the moveable portion includes contacting the intermediate section and not the end section of the fluid pathway to reduce contamination of the test zone.