Rapid blood expression and sampling

• US 7,766,846 B2
• Filed: 01/28/2008
• Issued: 08/03/2010
• Est. Priority Date: 01/28/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wong, Daniel, Patel, Paul
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/020,766
• Publication Number:
  US 20090192409A1
• Time in Patent Office: 918 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584
• 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 5/150022 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 5/150152 by an adequate mechanical impact on the puncturing location
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Claims

1. A method of sampling body fluid before reflexive action occurs, comprising:

pressing an expression unit against skin;

piercing the skin with a skin-piercing member that includes a fluid collection structure;

collecting the body fluid with the fluid collection structure after said piercing the skin;

removing the skin-piercing member from the skin; and

said collecting the body fluid and said removing the skin-piercing member occur before the reflexive action occurs as a result of said piercing the skin, in which said collecting the body fluid and said removing the skin-piercing member occur within 150 ms from the beginning of said piercing the skin.

2. The method of claim 1, in which said collecting the body fluid includes collecting the body fluid with the skin-piercing member that has a tip with an open section that has a length of at least 350 μ

m and at most 600 μ

m.

3. The method of claim 2, in which the length of the open section is about 425 μ

m.

4. The method of claim 2, further comprising:

wherein the skin-piercing member includes a micro-sampler and the fluid collection structure includes an open capillary channel of the micro-sampler;

wherein the open section that has a length of about 425 μ

m;

wherein said pressing includes applying at least 10 N of force to the skin;

wherein said collecting the body fluid and said removing the skin-piercing member occur within 75 ms from the beginning of said piercing the skin;

wherein said collecting the body fluid includes collecting 20 nl to 1 μ

l of the body fluid; and

depositing the body fluid onto an analysis means of the micro-sampler within 200 ms of said piercing the skin.

5. The method of claim 1, wherein said collecting results in at least a 90% success rate.

6. The method of claim 1, in which said collecting the body fluid and said removing the skin-piercing member occur within 100 ms from the beginning of said piercing the skin.

7. The method of claim 1, in which said collecting the body fluid and said removing the skin-piercing member occur within 75 ms from the beginning of said piercing the skin.

8. The method of claim 1, further comprising:

detecting a predetermined force is reached with a pressure sensitive trigger; and

initiating said piercing the skin in response to said detecting.

9. The method of claim 1, in which said pressing includes applying at least 6 N of force to the skin.

10. The method of claim 1, in which said pressing includes applying at least 8 N of force to the skin.

11. The method of claim 1, in which said pressing includes applying at least 10 N of force to the skin.

12. The method of claim 1, in which said pressing includes applying at least 12 N of force to the skin.

13. The method of claim 1, in which said collecting the body fluid includes collecting 20 nl to 1 μ

l of the body fluid.

14. The method of claim 1, in which said collecting the body fluid includes collecting 200 to 300 nl of the body fluid.

15. The method of claim 1, wherein:

said piercing includes an extension phase where the piercing member extends to a maximum penetration depth followed by a withdraw phase where the piercing member retracts from the maximum penetration depth; and

the withdraw phase is longer than the extension phase.

16. The method of claim 15, in which said piercing includes maintaining the piercing member at a dwell depth beneath the skin during the withdraw phase.

17. The method of claim 1, further comprising:

wherein the fluid collection structure includes an open capillary channel; and

depositing the body fluid onto an analysis means within 200 ms of said piercing the skin.

18. The method of claim 17, in which said depositing occurs within 75 ms of said piercing the skin.

19. The method of claim 17, further comprising analyzing the body fluid with the analysis means.

20. The method of claim 1, further comprising:

said collecting the body fluid includes adhering body fluid on the outside of the skin-piercing member; and

drawing the body fluid on the outside of the skin-piercing member into the fluid collection structure after said removing the skin-piercing member from the skin.

21. The method of claim 1, further comprising:

analyzing the fluid sample within 10 seconds of said piercing.

22. The method of claim 1, further comprising:

said collecting the body fluid and said removing the skin-piercing member occur from 75 to 200 ms from the beginning of said piercing the skin.

23. A method of collecting fluid from skin to achieve a high collection success rate, comprising:

pressurizing the fluid beneath the skin by pressing an expression member against the skin;

penetrating the skin with a micro-sampler, wherein the micro-sampler has a shaft with a tip, an open capillary channel defined along the shaft, and an entrance of the capillary channel that is recessed 350 to 600 μ

m from the tip of the shaft;

withdrawing the micro-sampler from the skin at a speed slower than during said penetrating the skin; and

removing the micro-sampler completely from the skin with a sufficient fluid sample for accurate testing at least clung to the micro-sampler within 150 ms of said penetrating.

24. The method of claim 23, further comprising:

wherein said pressurizing includes pressing the expression member against the skin with at least 10 N of force;

wherein said removing occurs within 75 ms of said penetrating; and

wherein the entrance of the capillary channel is recessed about 425 μ

m from the tip of the shaft.

25. The method of claim 23, in which said pressurizing includes pressing the expression member against the skin with at least 6 N of force.

26. The method of claim 23, in which said removing occurs within 75 ms of said penetrating.

27. The method of claim 26, in which said pressurizing includes pressing the expression member against the skin with at least 8 N of force.

28. The method of claim 27, in which the expression member is ring-shaped.

29. The method of claim 28, in which the expression member includes a flexible cone-type expression ring.

30. The method of claim 27, in which the entrance of the capillary channel is recessed about 425 μ

m from the tip of the shaft.

31. The method of claim 23, in which said pressurizing includes pressing the expression member against the skin with at least 8 N of force.

32. The method of claim 23, in which said pressurizing includes pressing the expression member against the skin with at most 12 N of force.

33. The method of claim 23, in which the sufficient fluid sample for accurate testing is at least 200 nl and at most 1 μ

l.

34. The method of claim 23, further comprising:

drawing at least some of the fluid clung to the micro-sampler that is outside the capillary channel into the capillary channel after said removing the micro-sampler completely from the skin.

35. The method of claim 23, further comprising:

drawing the sufficient fluid sample for accurate testing is inside the capillary channel before said removing the micro-sampler completely from the skin.

36. The method of claim 23, further comprising:

firing the micro-sampler when the expression member is pressed at least to a predetermined force against the skin.

37. The method of claim 23, further comprising depositing the fluid sample onto an analysis means of the micro-sampler before significant evaporation of the fluid sample occurs.

38. The method of claim 37, in which said depositing the fluid sample onto the analysis means occurs within about 500 ms of said penetrating the skin.

39. The method of claim 38, in which said depositing the fluid sample onto the analysis means occurs within about 75 ms of said penetrating the skin.

40. The method of claim 23, further comprising:

loading the micro-sampler into a meter before said penetrating the skin; and

unloading the micro-sampler from the meter after said removing the micro-sampler completely from the skin.

41. An apparatus, comprising:

a micro-sampler configured to collect body fluid from skin, the micro-sampler including

a body,

a shaft with a pointed tip extending from the body to penetrate the skin,

an open capillary channel extending along the shaft with a capillary channel opening for collecting the body fluid via capillary action, the capillary channel being hydrophilic, the capillary channel opening being located between 350 to 600 μ

m from the pointed tip; and

wherein the shaft has an open section located between the capillary channel opening and the pointed tip, the open section being configured to provide an insufficient contact area to draw fluid via capillary action.

42. The apparatus of claim 41, wherein the capillary channel opening is located about 425 μ

m from the pointed tip.

43. The apparatus of claim 41, the pointed tip having a blade angle from 20°

to 40°

.

44. The apparatus of claim 41, the capillary channel having an aspect ratio from 0.7 to 1.6.

45. The apparatus of claim 41, further comprising:

a firing mechanism for firing the micro-sampler into the skin, the firing mechanism including a pressure sensitive trigger configured to fire the firing mechanism when at least 6 N of force is applied against the skin.

46. The apparatus of claim 41, further comprising:

a meter in which the micro-sampler is loaded, the meter including an expression ring made from a hard inner ring that is over molded with a flexible material.

47. The apparatus of claim 41, further comprising:

the capillary channel opening being located about 425 μ

m from the pointed tip;

the pointed tip having a blade angle from 20°

to 40°

; and

the capillary channel having an aspect ratio from 0.7 to 1.6.