METHODS AND APPARATUS FOR SAMPLING AND ANALYZING BODY FLUID

• US 20080015425A1
• Filed: 07/16/2007
• Published: 01/17/2008
• Est. Priority Date: 05/17/1996
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Douglas, Joel, Duchon, Brent, Radwanski, Ryszard, Roe, Jeffrey
• Granted Patent: US 7,731,668 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 sampling device in contact with an alternate site, wherein the alternate site is at a location on a body other than a fingertip;

creating an incision in the alternate site with the sampling device; and

testing body fluid on the surface of the alternate site from the incision with the sampling device while the sampling device remains in contact with the alternate site.

2. The method of claim 1, further comprising sampling the body fluid from the incision with the sampling device before said testing.

3. The method of claim 2, wherein said sampling the body fluid includes drawing fluid into a capillary in the sampling device via capillary action.

4. The method of claim 3, wherein said testing includes analyzing the body fluid with a test strip disposed along the capillary.

5. The method of claim 2, wherein said sampling includes:

moving a capillary from a first position where the capillary is displaced from the skin to a second position where the capillary is adjacent the skin while the sampling device remains in contact with the skin; and

drawing the body fluid from the incision into the capillary via capillary action.

6. The method of claim 1, wherein said testing includes analyzing the body fluid with a test strip disposed at an end of the sampling device proximal the skin.

7. The method of claim 1, wherein the alternate site is an earlobe or a limb.

8. A method, comprising:

positioning a lancing device in contact with an alternate site that is located on skin at a body part other than a fingertip, wherein the lancing device houses a disposable that includes a lancet and a test strip;

forming an incision in the alternate site with the lancet of the disposable; and

analyzing the body fluid from the incision with the test strip of the disposable.

9. The method of claim 8, further comprising:

expressing the body fluid from the incision with the lancing device before said analyzing; and

wherein said expressing includes pushing the lancing device further against the alternate site after said placing to depress a ring of the skin around the incision to cause the incision to bulge while spreading apart the incision.

10. The method of claim 9, further comprising:

wherein the lancing device includes a stimulator member; and

wherein said expressing includes pressing the stimulator member around the incision.

11. The method of claim 8, further comprising:

removing the disposable from the lancing device after said analyzing;

discarding the disposable after said removing; and

loading a fresh disposable into the lancing device.

12. The method of claim 8, further comprising:

wherein the disposable includes a capillary; and

drawing the body fluid into the test strip via the capillary before said analyzing.

13. The method of claim 8, 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.

14. The method of claim 13, further comprising:

alerting a user of drop sufficiency with the lancing device.

15. The method of claim 13, wherein said detecting the drop includes electrically detecting the drop.

16. The method of claim 13, wherein said detecting the drop includes optically detecting the drop.

17. The method of claim 8, wherein said analyzing includes analyzing the body fluid using an optical technique.

18. The method of claim 8, wherein said analyzing includes analyzing the body fluid using an electrochemical technique.

19. The method of claim 8, wherein the alternate site includes a limb.

20. The method of claim 8, wherein the lancing device remains in contact with the alternate site during said forming and said analyzing.

21. The method of claim 8, further comprising:

loading the disposable into the lancing device before said positioning the lancing device in contact with the alternate site;

wherein the test strip has a capillary passage with a capillary opening configured to draw the body fluid via capillary action;

wherein said forming the incision includes

firing the disposable towards the alternate site, wherein during said firing the lancet and the test strip of the disposable move together as a single unit towards the alternate site, and

retracting the disposable away from the incision;

contacting the capillary opening with a drop of the body fluid from the incision on the surface of the alternate site by extending the capillary opening past the lancet;

drawing via capillary action the body fluid from the drop into the capillary passage before said analyzing the body fluid;

unloading the disposable from the lancing device after said analyzing;

discarding the disposable after said unloading; and

loading a fresh disposable into the lancing device.

22. The method of claim 21, further comprising:

wherein the lancing device includes an electrochemical meter;

wherein the test strip includes an electrochemical test strip;

electrically connecting the electrochemical meter to the electrochemical test strip; and

wherein said analyzing includes electrochemically analyzing the body fluid.

23. The method of claim 22, wherein said electrochemically analyzing the body fluid includes measuring current of the electrochemical test strip.

24. The method of claim 22, wherein said analyzing includes measuring glucose concentration in the body fluid.

25. The method of claim 21, wherein:

the test strip is an optical test strip; and

wherein said analyzing includes optically analyzing the body fluid.

26. A method, comprising:

loading a disposable into a lancing device that includes a lancet and a test strip with a capillary passage that has a capillary opening configured to draw body fluid via capillary action;

placing the lancing device in contact with skin;

firing the disposable towards the skin with the lancing device, wherein during said firing the lancet and the test strip of the disposable move together as a single unit towards the skin;

retracting the disposable away from the incision;

moving the capillary opening of the capillary passage past the lancet to contact the capillary opening with a drop of body fluid from the incision on the surface of the skin;

drawing via capillary action the body fluid from the drop into the capillary passage;

analyzing the body fluid from the incision with the test strip;

unloading the disposable from the lancing device after said analyzing;

discarding the disposable after said loading; and

loading a fresh disposable into the lancing device after said unloading.

27. The method of claim 26, further comprising:

pressing the lancing device further against the skin with force in addition to that applied by said placing to express the body fluid from the incision; and

wherein said pressing includes depressing a ring of the skin around the incision to cause the incision to bulge while spreading apart the incision.

28. The method of claim 27, further comprising:

determining automatically with a drop sensing mechanism in the lancing device whether the drop of the body fluid expressed from the incision is of sufficient size to provide a proper sample.

29. The method of claim 28, further comprising:

energizing an indicator on the lancing device when the drop of the body fluid expressed from the incision is of sufficient size to provide the proper sample.

30. A method, comprising:

placing a lancing device against a region of skin where the supply of body fluid is relatively low as compared to a fingertip, 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 at the region with the lancet of the first disposable by firing the first disposable towards the skin and retracting the first disposable away from the skin with the lancing device;

expressing body fluid from the incision by pressing the lancing device further against the skin after said forming the incision to spread open the incision;

positioning the passage opening of the capillary passage into contact with the body fluid on the surface of the skin while the lancing device remains in contact with the skin after said expressing;

drawing via capillary action the body fluid on the surface of the skin into the capillary passage while the lancing device remains in contact with the skin;

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.

31. The method of claim 30, wherein said analyzing the body fluid includes optically analyzing the body fluid.

32. The method of claim 30, wherein said analyzing the body fluid includes electrochemically analyzing the body fluid.

33. The method of claim 30, further comprising:

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

34. A method, comprising:

placing a lancing device against skin, wherein the lancing device houses a disposable that includes a lancet and a test strip;

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

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

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

contacting the electrical leads of the electrochemical meter to the printed electrical circuit paths of the test strip of the disposable after said forming the incision; and

analyzing the body fluid from the incision with the test strip of the disposable by electrochemical analysis.

35. The method of claim 34, further comprising:

discarding the disposable after said analyzing; and

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

36. The method of claim 34, further comprising:

wherein the disposable includes a capillary passage;

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

said contacting the electrical leads occurs after said lowering the capillary passage.

37. The method of claim 36, 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 after said pushing the capillary passage down with the pusher.

38. The method of claim 34, wherein the skin is located at a region where the supply of the body fluid is relatively low as compared to a fingertip.

39. The method of claim 38, further comprising expressing the body fluid from the incision.