Methods and apparatus for sampling and analyzing body fluid

• US 7,247,144 B2
• Filed: 07/03/2003
• Issued: 07/24/2007
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Apanius; Michael
• Application Number:
  US10/612,852
• Publication Number:
  US 20040006285A1
• Time in Patent Office: 1,482 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/150213 Venting means
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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
• 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

Abstract

A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Claims

1. A method, comprising:

placing a stimulator sleeve of a lancing device against a region of skin where nerve density is low and supply of body fluid is low, wherein the lancing device houses a first disposable that includes a lancet and a test strip;

cutting an incision in the skin at the region with the lancet of the first disposable;

expressing the body fluid from the incision with the stimulator sleeve;

drawing the body fluid into the test strip from the surface of the skin while the stimulator sleeves remains in contact with the skin;

analyzing the body fluid from the incision with the test strip of the first disposable;

discarding the first disposable after said analyzing;

loading a second disposable into the lancing device after said discarding the first disposable;

wherein the first disposable includes a capillary passage;

wherein said cutting the incision includes

firing the first disposable with the lancet, the test strip, and the capillary passage towards the skin at the region, and

retracting the first disposable from the skin;

wherein the lancet, the test strip, and the capillary passage of the first disposable move together as a single unit during said firing and said retracting; and

wherein said drawing the body fluid into the test strip includes

lowering the capillary passage into contact with the body fluid on the surface of the skin after said retracting and said expressing, and

transporting via capillary action the body fluid from the surface of the skin to the test strip through the capillary passage.

2. The method of claim 1, further comprising:

detecting drop sufficiency of the body fluid with a drop detection mechanism in the lancing device before said drawing.

3. The method of claim 1, wherein said expressing includes pressing the stimulator sleeve against the skin.

4. The method of claim 1, wherein the region of the skin where nerve density is low and supply of body fluid is low is an earlobe or a limb.

5. The method of claim 1, wherein said analyzing the body fluid includes optically analyzing the body fluid.

6. The method of claim 1, wherein said analyzing the body fluid includes electrochemically analyzing the body fluid.

7. The method of claim 6, further comprising:

wherein the test strip of the first disposable includes printed electrical circuit paths;

wherein the lancing device includes an electrochemical meter with electrical leads; and

contacting the electrical leads of the electrochemical meter to the printed electrical circuit paths of the test strip of the first disposable.

8. The method of claim 7, wherein said contacting the electrical leads occurs as a result of said lowering the capillary passage.

9. The method of claim 8, wherein:

the lancing device includes a pusher;

the pusher has the electrical leads;

said lowering the capillary passage into contact with the body fluid on the surface of the skin includes pushing the capillary passage down with the pusher; and

said contacting the electrical leads occurs as a result of said pushing the capillary passage down with the pusher.

10. The method of claim 8, further comprising:

loading the first disposable into the lancing device; and

said contacting the electrical leads occurs after said loading the first disposable.

11. The method of claim 10, wherein said contacting the electrical leads occurs after said cutting the incision.

12. The method of claim 1, wherein said drawing the body fluid into the test strip includes relieving backpressure by venting air through a vent opening.

13. A method, comprising:

placing a lancing device against skin, wherein the lancing device houses a first disposable that includes a lancet, a test strip, and a capillary passage with a passage opening;

forming an incision in the skin, wherein said forming the incision includes firing the first disposable towards the skin, wherein during said firing the lancet, the test strip and the capillary passage of the first disposable move together as a single unit towards the skin;

positioning the passage opening of the capillary passage into contact with body fluid from the incision on the surface of the skin, wherein during said positioning the passage opening of the capillary passage extends past the lancet;

drawing via capillary action the body fluid on the surface of the skin into the capillary passage;

transporting the body fluid from the capillary passage to the test strip;

analyzing the body fluid from the incision with the test strip of the first disposable;

discarding the first disposable after said analyzing; and

loading a second disposable into the lancing device after said discarding the first disposable.

14. The method of claim 13, wherein the skin is located at a region where the supply of the body fluid is relatively low as compared to a fingertip.

15. The method of claim 14, further comprising expressing the body fluid from the incision before said drawing.

16. The method of claim 15, wherein said expressing includes pressing a stimulator sleeve of the lancing device against the skin.

17. The method of claim 13, wherein the lancing device remains in contact with the skin during said positioning.

18. The method of claim 13, further comprising:

wherein the lancing device includes a drop detecting mechanism; and

detecting that a drop of the body fluid on the skin is of sufficient size with the drop detecting mechanism before said drawing.

19. The method of claim 18, further comprising:

alerting a user of drop sufficiency with the lancing device.

20. The method of claim 18, wherein said detecting includes electrically detecting the drop.

21. The method of claim 18, wherein said detecting includes optically detecting the drop.

22. The method of claim 13, wherein said analyzing the body fluid includes optically analyzing the body fluid.

23. The method of claim 13, wherein said analyzing the body fluid includes electrochemically analyzing the body fluid.

24. The method of claim 13, wherein the region of the skin where the supply of body fluid is relatively low is an earlobe or a limb.

25. A method, comprising:

placing a stimulator sleeve of a lancing device against a region of skin where nerve density is low and supply of body fluid is low, wherein the lancing device houses a first disposable that includes a lancet and a test strip;

cutting an incision in the skin at the region with the lancet of the first disposable;

expressing the body fluid from the incision with the stimulator sleeve;

drawing the body fluid into the test strip from the surface of the skin while the stimulator sleeves remains in contact with the skin;

analyzing the body fluid from the incision with the test strip of the first disposable;

discarding the first disposable after said analyzing;

loading a second disposable into the lancing device after said discarding the first disposable;

wherein said analyzing the body fluid includes electrochemically analyzing the body fluid;

wherein the test strip of the first disposable includes printed electrical circuit paths;

wherein the lancing device includes an electrochemical meter with electrical leads;

contacting the electrical leads of the electrochemical meter to the printed electrical circuit paths of the test strip of the first disposable;

wherein the first disposable includes a capillary passage;

wherein said drawing the body fluid into the test strip includes lowering the capillary passage into contact with the body fluid on the surface of the skin; and

wherein said contacting the electrical leads occurs as a result of said lowering the capillary passage.

26. The method of claim 25, wherein:

the lancing device includes a pusher;

the pusher has the electrical leads;

said lowering the capillary passage into contact with the body fluid on the surface of the skin includes pushing the capillary passage down with the pusher; and

said contacting the electrical leads occurs as a result of said pushing the capillary passage down with the pusher.

27. The method of claim 25, further comprising:

loading the first disposable into the lancing device; and

said contacting the electrical leads occurs after said loading the first disposable.

28. The method of claim 27, wherein said contacting the electrical leads occurs after said cutting the incision.

29. The method of claim 25, wherein:

said cutting the incision includes

firing the first disposable with the lancet, the test strip, and the capillary passage

against the skin at the region, and

retracting the first disposable from the skin;

the lancet, the test strip, and the capillary passage of the first disposable move together as a single unit during said firing and said retracting; and

said lowering the capillary passage into contact with the body fluid on the surface of the skin occurs after said retracting.

30. The method of claim 25, further comprising:

detecting a drop of the body fluid from the incision is sufficient for said analyzing with a drop sensing mechanism in the lancing device.

31. The method of claim 30, further comprising:

alerting a user of drop sufficiency with the lancing device.

32. The method of claim 30, wherein said detecting the drop includes electrically detecting the drop.

33. The method of claim 30, wherein said detecting the drop includes optically detecting the drop.

34. The method of claim 25, wherein said expressing includes pressing the stimulator sleeve against the skin.

35. The method of claim 25, wherein the region of the skin where nerve density is low and supply of body fluid is low is an earlobe or a limb.