BODY FLUID SAMPLING DEVICE

• US 20070038149A1
• Filed: 09/05/2006
• Published: 02/15/2007
• 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, Griss, Patrick, Sarofim, Emad, Jaeggi, Rainer
• Granted Patent: US 8,162,854 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 said fluid pathway is open to the environment and further comprising a fluid receiving means (40) being spaced from said fluid pathway so that fluid in said pathway will not contact the fluid receiving means initially. Said fluid receiving means may have a test zone (45) for performing an analytical reaction. Fluid from said channel is contacted with said fluid receiving means either by bringing the fluid receiving means and the fluid into mechanical contact or by electrically transporting fluid from the channel onto the fluid receiving means.

Claims

1. Device for sampling body fluid comprising

a fluid pathway (11) for receiving body fluid in a first state, wherein at least a portion of said fluid pathway (11) along its longitudinal extension is open to the environment and

a fluid receiving means (40) being separately spaced apart from said fluid pathway (11) so that body fluid in said pathway (11) is out of fluidic contact with the fluid receiving means (40) in the first separated state,

the device being adapted to undergo a physical change upon actuation so as to assume a second contacting state in which a fluid in said fluid pathway (11) contacts said fluid receiving means (40),

wherein said device having a moveable portion (13) which can be moved and at least a portion of said fluid pathway (11) or fluid receiving means (40) is located on said moveable portion (13) to assume the contacting state.

3. Device according to claim 1, further comprising a skin piercing element (10) having said fluid pathway (11).

4. Device according to claim 1, wherein the fluid receiving means (40) comprises a test zone (45).

5. Device according to claim 1, wherein the fluid receiving means (40) is separated from the fluid pathway (11) by an air gap (92).

6. Device according to claim 5, wherein the air gap (92) is maintained by spacers (90).

7. Device according to claim 3, wherein said skin piercing element (10) has a fluid transfer region and at least a portion of said fluid pathway (11) in said fluid transfer region has pointed walls (11′

).

8. Device according to claim 7, wherein said fluid receiving means (40) comprises a layer structure that can be depressed or cut by said pointed walls (11′

).

9. Device according to claim 1, wherein body fluid received in said fluid pathway (11) is moved by electrical actuation onto the fluid receiving means (40).

11. Device according to claim 1, wherein the fluid pathway (11) or the fluid receiving means (40) have confining means for confining the area of fluid transfer from the fluid pathway (11) onto the fluid receiving means (40).

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

13. Device according to claim 1, wherein a surface adjacent to the fluid pathway (11) is hydrophobic.

14. Device according to claim 1, wherein said fluid receiving means (40) comprises a test zone (45) and at least one of a reaction zone, a filtration zone and a mixing zone.

15. Device according to claim 1, wherein said skin-piercing element has two or more fluid pathways (11).

16. Device according to claim 1, wherein said fluid pathway (11) in a first region (a) has a first width and in another region (c) has a second width which is smaller than the first width.

17. Device according to claim 16, wherein said fluid pathway (11) further comprises a collecting zone (b).

18. Device according to claim 14, wherein said test zone (45) is located in or contacted with an intermediate portion of the fluid pathway (11) so that the fluid portion entering the pathway first is not contacted with the test zone (45).

19. Device according to claim 1, wherein the fluid pathway (11) has a sampling section (100) and at least one discharge section (102) located downstream the sampling section (100) and/or branching off upstream the sampling section (100) for receiving a fraction of the body fluid entering the pathway (11) first, and wherein the sampling section (100) is a test zone (45) or can be contacted with a test zone (45) for analysis of body fluid contained therein.

2. Device for sampling body fluid comprising

a fluid pathway (11) for receiving body fluid in a first state, wherein at least a portion of said fluid pathway (11) along its longitudinal extension is open to the environment and

a fluid receiving means (40) being separately spaced apart from said fluid pathway (11) by an air gap (92) so that body fluid in said pathway (11) is out of fluidic contact with the fluid receiving means (40) in the first separated state,

the device being adapted to undergo a physical change upon actuation so as to assume a second contacting state in which a fluid in said fluid pathway (11) contacts said fluid receiving means (40),

wherein body fluid received in said fluid pathway (11) is moved by electrical actuation onto the fluid receiving means (40).

10. Device according to claim 2, wherein the skin piercing element (10) has a collection zone (26) in which upstanding elements (26′

) are located.

20. Device for sampling body fluid comprising a skin piercing element (10) with a capillary channel as a laterally open fluid pathway (11) for receiving body fluid, wherein the channel has a sampling section (100) and at least one discharge section (102) located downstream the sampling section (100) and/or branching off upstream the sampling section (100) for receiving and discharging a fraction of the body fluid entering the capillary first, and wherein the sampling section (100) is a test zone (45) or is contacted with a test zone (45) for analysis of body fluid contained therein.

21. Device according to claim 20, wherein the sampling section (100) is filled through an inlet section (106) of the capillary channel (11), the capillarity of the inlet section (106) being smaller than the capillarity of the at least one discharge section (102) branching off the inlet section.

22. Device according to claim 20, wherein the capillarity of the discharge section (102) is increased by means of a lid (110) closing an open side portion of the discharge section (102).

23. Device according to claim 20, wherein the discharge section (102) has a waste region (114) and a reservoir region (116) upstream of the waste region (114), and wherein body fluid from the reservoir region (116) is fed to the sampling section (100) after an uptake phase.

24. Device according to claim 20, wherein the capillarity of the sampling section (100) is increased through contact of a fluid receiving means (40) after filling of the discharge section (102).

25. Device according to claim 20, wherein the volume of the discharge section (102) is larger than the volume of the sampling section (100).

26. Device for body fluid analysis comprising

a skin piercing element (10) with a fluid pathway (11) for receiving body fluid, wherein at least a portion of said fluid pathway (11) is open to the environment and

a fluid receiving means (40) being spaced from said fluid pathway (11) so that fluid in said pathway is out of fluidic contact with the fluid receiving means (40),

said fluid receiving means (40) comprising a test zone (45).

27. Device according to claim 26, comprising a meter with a detection unit for receiving signals from said test zone (45) to determine the presence and/or concentration of an analyte.

28. Device according to claim 27, wherein said meter includes a holder in which said fluid receiving means (40) is received and signal transmission from the test zone (45) to the detector is enabled.

29. Device according to claim 26, comprising a contacting means which contacts a portion of the fluid pathway (11) with the fluid receiving means (40) to provide the test zone (45) with sample fluid.

30. Device according to claim 28, wherein said meter has a processing unit that receives a signal indicating that the contacting means has contacted the fluid pathway (11) with the fluid receiving means (40) or that sample fluid has reached the test zone (45).

31. Device according to claim 29, wherein said contacting means comprises voltage means for applying an electrical potential between said fluid pathway (11) and said fluid receiving means (40) so that fluid from the fluid pathway (11) contacts the fluid receiving means (40).

32. Device according to claim 29, wherein said contacting means applies a force to a moveable portion (13) of the fluid pathway (11) or the fluid receiving means (40) to bring the fluid pathway (11) and the fluid receiving means (40) into mutual contact.

33. Device according to claim 26, comprising a magnetic contacting means (74,76) for applying a magnetic field (72) to bring the fluid pathway (11) and the fluid receiving means (40) into fluid transferring contact.

34. Device according to claim 33, wherein the magnetic contacting means (74,76) includes a permanent magnet, an electromagnet (76), a solenoid or a current carrying wire.

35. Device according to claim 33, wherein at least one of a paramagnetic or ferromagnetic material (74) 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 (11) and/or of the fluid receiving means (40).

36. Device according to claim 29, wherein the contacting means has an optical matching element (80) for coupling the test zone (45) to an optical detection unit, the optical matching element (80) being adapted for exerting a mechanical force to bring the fluid pathway (11) and the fluid receiving means (40) into a contacting state.

37. Device according to claim 36, wherein the optical detection unit includes a reflectometer connected to the optical matching element (80) via an optics comprising lenses, optical waveguides and/or optical fibres (94).

38. Device according to claim 36, wherein the optical matching element (80) is provided by a coating of the optics facing the test zone (45).

39. Device according to claim 36, wherein the optical matching element (80) has a refractive index matched to the refractive index of the test zone (45).

40. Device according to claim 36, wherein the optical matching element (80) consists of an elastomeric material.

41. Device according to claim 36, wherein the optical matching element (80) is arranged on a side of the test zone (45) opposite to the fluid pathway (11) 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 (11) and the test zone (45).

42. Device according to claim 26, comprising a drive means for driving the skin piercing element (10) into skin to pierce the skin for obtaining a body fluid sample.

43. Method for determining an analyte concentration in body fluid comprising the steps of:

a) receiving body fluid in a fluid pathway (11) preferably of a skin piercing element (10), the fluid pathway (11) being spatially separated from a fluid receiving means (40) during filling,

b) contacting the fluid pathway (11) with the fluid receiving means (40) so that body fluid from the fluid pathway (11) contacts the fluid receiving means (40) and reaches a test zone (45),

c) receiving signals from said test zone (45) which are characteristic for an analyte concentration,

d) processing said signals to determine the analyte concentration.

44. Method according to claim 43, wherein a time period beginning with step b) is monitored and determination of analyte concentration is initiated based on the time passed.

45. Method according to claim 43, 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.

46. Method according to claim 43, comprising pricking skin with said skin piercing element (10).

47. Analytical device comprising

a support structure having a channel (11) therein which is accessible from the surrounding in at least an access region, said channel having a fluid introduction region (a) as well as a discharge region (d) located downstream the access region

a fluid receiving means (40),

the fluid receiving means (40) being spaced from the channel in a first state and the fluid receiving means (40) being in contact with fluid located in the access region in a second state to receive fluid, so that the fluid receiving means (40) is not contacted with a fluid from the discharge region.

48. Method of sampling fluid comprising the steps of

introducing fluid into an introduction region of a support structure which has a channel therein, said fluid filling an access region of the support structure which is accessible from the surrounding and having a waste region (114) located downstream the access region

contacting a fluid receiving means (40) with fluid located in the access region to receive fluid but not with a fluid portion in the discharge region.

49. Analytical device comprising

a support structure having a channel for receiving fluid therein which is accessible from the surrounding in at least an access region,

a fluid receiving means (40) being spaced from the channel

a source of electrical potential which when turned on applies an electrical potential between fluid in said access region and said fluid receiving means (40) so that fluid from said access region is transported onto said fluid receiving means (40).

50. Analytical device according to claim 49, wherein the fluid receiving means (40) comprises a test zone (45).

51. Analytical device according to claim 49, wherein the access region is an enlarged portion of the channel which forms an open chamber and in the chamber there are located upstanding elements.

52. Method for transporting fluid from a support structure to a fluid receiving means (40), comprising the steps of

holding a support structure having a channel for receiving fluid therein which is accessible from the surrounding in at least an access region in a spaced relationship to a fluid receiving means (40),

applying an electrical potential between fluid in said access region and said fluid receiving means (40) so that fluid from said access region is transported onto said fluid receiving means (40).

53. System for body fluid analysis comprising

a skin-piercing element with a fluid pathway (11) for receiving body fluid, wherein at least a portion of said fluid pathway (11) is open to the environment and

a fluid receiving means (40) being spaced from said fluid pathway (11) so that fluid in said pathway will not contact the fluid receiving means (40), said fluid receiving means (40) comprising a test zone (45),

a transport means to transport the skin piercing element (10) into contact with the fluid receiving means (40).

54. System according to claim 53, further comprising

a magazine storing multiple fluid receiving means (40).

55. System according to claim 54, further comprising an exposing unit for successively exposing fluid receiving means (40) from said magazine to receive fluid.