Methods and apparatus for sampling and analyzing body fluid

• US 8,690,798 B2
• Filed: 05/03/2012
• Issued: 04/08/2014
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Douglas, Joel S., Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/462,902
• Publication Number:
  US 20120215084A1
• Time in Patent Office: 705 Days
• Field of Search: 600/573, 600/576, 600/584, 606181-183
• 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 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 disposable includes a capillary passage with a capillary opening;

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;

retracting the disposable away from the incision;

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

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

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

2. The method of claim 1, further comprising:

discarding the disposable after said analyzing; and

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

3. The method of claim 1, 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.

4. The method of claim 3, 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.

5. The method of claim 1, wherein the skin is located at a region where the supply of the body fluid is relatively low as compared to a fingertip.

6. The method of claim 5, further comprising expressing the body fluid from the incision.

7. The method of claim 1, further comprising:

wherein the disposable includes a capillary; and

drawing the body fluid into the capillary via capillary action before said analyzing.

8. The method of claim 7, further comprising:

moving the 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 lancing device remains in contact with the skin before said drawing the body fluid.

9. The method of claim 1, 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 skin 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 1, 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.

12. The method of claim 11, further comprising:

alerting a user of drop sufficiency with the lancing device.

13. The method of claim 11, wherein said detecting the drop includes electrically detecting the drop.

14. The method of claim 1, wherein said analyzing the body fluid includes measuring current with the test strip.

15. The method of claim 1, wherein said analyzing includes measuring glucose concentration in the body fluid.

16. The method of claim 1, further comprising:

wherein the capillary passage fluidly communicates with the test strip;

wherein the lancing device includes a pusher that has the electrical leads;

wherein said contacting the capillary opening with the drop of the body fluid includes extending the capillary opening past the lancet with the pusher by moving the pusher to a lower position; and

wherein said contacting the electrical leads occurs when the pusher is at the lower position.

17. 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;

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

loading the disposable into the lancing device before said placing the lancing device against an 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 skin, wherein during said firing the lancet and the test strip of the disposable move together as a single unit towards the skin, 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 skin 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.