Integrated disposable for automatic or manual blood dosing

• US 7,322,942 B2
• Filed: 05/07/2004
• Issued: 01/29/2008
• Est. Priority Date: 05/07/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N.
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US10/840,931
• Publication Number:
  US 20050251064A1
• Time in Patent Office: 1,362 Days
• Field of Search: 604/411, 604/272, 604/322, 600/583, 600/584, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/150213 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable

Abstract

An integrated sampling device defines a first opening and a second opening. The first opening is connected to a channel for drawing fluid automatically towards a test media upon incision by an incision portion. The second opening is positioned over the test media allowing manual sampling of fluid if the channel fails to draw a sufficient amount of fluid onto the test media.

Claims

1. An integrated sampling device for analyzing body fluid, comprising:

a sampling portion defining a channel with a first opening;

a test media positioned along said channel for analyzing the body fluid;

wherein said sampling portion defines a second opening that is positioned closer to said test media than said first opening for dosing the body fluid onto said test media via said second opening when dosing of the body fluid via said first opening is unsuccessful;

wherein said second opening opens into said channel directly over said test media;

a blade extending from said first opening to cut an incision in tissue; and

a collection sheet distally extending beyond said blade from said first opening, said collection sheet being flexible to bend as said blade cuts the incision in the tissue, said collection sheet being hydrophilic to draw the body fluid into said first opening.

2. The device of claim 1, wherein said sampling portion is generally flat.

3. The device of claim 1, wherein said sampling portion and said test media are incorporated into a cassette.

4. The device of claim 1, wherein said sampling portion includes:

a lancet with a blade that extends from said first opening;

at least two spacers on said lancet defining opposite sides of said channel, wherein said second opening is defined in at least one of said two spacers; and

a collection sheet covering said two spacers, said collection sheet having a portion extending from said first opening for drawing fluid into said first opening.

5. The device of claim 1, wherein said test media is disposed opposite the second opening to have the body fluid drop onto the test media.

6. An integrated sampling device for analyzing body fluid, comprising:

a sampling portion defining a channel with a first opening;

a test media positioned along said channel for analyzing the body fluid;

wherein said sampling portion defines a second opening that is positioned closer to said test media than said first opening for dosing the body fluid onto said test media via said second opening when dosing of the body fluid via said first opening is unsuccessful;

wherein said second opening opens into said channel directly over said test media; and

wherein said sampling portion includes a lancet, wherein said lancet includes a body portion and a blade that extends from said body portion at said first opening, said second opening being defined in said body portion of said lancet.

7. The device of claim 6, wherein said channel is sized to draw the body fluid via capillary action.

8. The device of claim 6, wherein said sampling portion includes:

at least two spacers on said lancet defining opposite sides of said channel; and

a collection sheet covering said two spacers, said collection sheet having a portion extending from said first opening for drawing fluid into said first opening.

9. The device of claim 8 wherein said collection sheet is transparent to allow determination of sufficiency of the body fluid in said channel.

10. The device of claim 6, wherein the second opening is located away from the blade.

11. A method, comprising:

forming an incision with a lancet of an integrated sampling device that includes a capillary channel with a first opening, test media disposed along the capillary channel and a second opening located along the capillary channel;

drawing body fluid from the incision automatically into the capillary channel via the first opening of the integrated sampling device;

detecting that the body fluid in the capillary channel is insufficient to allow analysis;

depositing the body fluid from the incision manually into the second opening after said detecting; and

analyzing the body fluid with the test media of the integrated sampling device.

12. The method of claim 11, wherein said drawing includes:

contacting a fluid collection sheet of the integrated sampling device to the body fluid; and

wicking the body fluid into the first opening with the fluid collection sheet.

13. The method of claim 11, wherein said analyzing includes optical testing.

14. The method of claim 11, wherein said analyzing includes electrochemical testing.

15. The method of claim 11, wherein said detecting includes visually determining that the body fluid drawn into the first opening is insufficient.

16. The method of claim 11, wherein said detecting includes automatically determining that the body fluid drawn into the first opening is insufficient with a sensor in the integrated sampling device.

17. The method of claim 11, further comprising:

expressing the body fluid from the incision before said detecting.

18. The method of claim 11, further comprising:

loading the integrated sampling device into a firing mechanism before said forming;

wherein said forming includes firing the integrated sampling device with the firing mechanism; and

disposing of the integrated sampling device by unloading the integrated sampling device from the firing mechanism after said analysis.

19. A method, comprising:

loading an integrated disposable into a body fluid sampling device that includes a firing mechanism, wherein the integrated disposable includes a lancet, a capillary channel with a first opening, test media disposed along the capillary channel and a second opening located along the capillary channel remote from the first opening;

forming an incision by firing the lancet of the integrated disposable into tissue with the firing mechanism;

drawing body fluid from the incision into the first opening of the capillary channel of the integrated disposable via capillary action;

detecting that the body fluid in the capillary channel is insufficient to allow analysis;

positioning the second opening of the integrated disposable at the incision after said detecting;

depositing the body fluid from the incision into the second opening;

analyzing the body fluid with the test media of the integrated disposable;

unloading the integrated disposable from body fluid sampling device; and

disposing of the integrated disposable.

20. The method of claim 19, wherein said positioning the second opening includes moving the second opening manually to the incision.

21. The method of claim 20, wherein said unloading the integrated disposable occurs before said moving the second opening manually to the incision.

22. The method of claim 20, wherein the integrated disposable remains attached to the body fluid sampling device during said moving the second opening manually to the incision.

23. The method of claim 19, wherein said drawing body fluid from the incision into the first opening includes wicking the fluid up a hydrophilic sheet into the first opening.