Methods and apparatus for sampling and analyzing body fluid

• US 6,352,514 B1
• Filed: 04/19/2000
• Issued: 03/05/2002
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/552,243
• Time in Patent Office: 685 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 of testing for the presence or concentration of an analyte in a sample of body fluid, the method comprising:

lancing a surface of the skin other than a fingertip surface to form an incision;

pressing a nose having an angled surface on to the surface of the skin thereby depressing a ring of body tissue surrounding the incision so as to express a drop of body fluid from the incision;

moving a capillary adjacent to the incision from an area remote to the incision;

transporting the body fluid to a test area via the capillary; and

measuring the presence or concentration of the analyte contained in the body fluid at the test area.

2. The method of claim 1, wherein the body fluid comprises an interstitial fluid.

3. The method of claim 1, wherein the presence or concentration of analyte is measured electrochemically.

4. The method of claim 1, wherein the presence or concentration of analyte is measured optically.

5. The method of claim 1, wherein the analyte comprises glucose and the body fluid comprises interstitial fluid.

6. The method of claim 1, wherein the body fluid is transported without the assistance of an applied vacuum.

7. The method of claim 1, wherein the step of transporting comprises transporting a predetermined volume of the body fluid to the test area.

8. An arrangement comprising:

a lancing member for forming an incision;

a nose having an angled surface for depressing a ring of body tissue surrounding the incision and thereby expressing a drop of body fluid from the incision;

a capillary for transporting the body fluid, the capillary being movable relative to the nose;

a test area in communication with the capillary; and

an analyzing mechanism for determining the presence or concentration of an analyte in the body fluid.

9. The arrangement of claim 8, wherein the lancing member, capillary, test area and analyzing mechanism are all provided within a common housing.

10. The arrangement of claim 8, wherein the body fluid comprises interstitial fluid.

11. The arrangement of claim 8, wherein the analyzing mechanism comprises an electrochemical analyzing mechanism.

12. The arrangement of claim 8, wherein the analyzing mechanism comprises an optical analyzing mechanism.

13. The arrangement of claim 8, wherein the capillary is constructed for transporting the body fluid without the assistance of an applied vacuum.

14. The arrangement of claim 8, wherein the capillary is provided with a predetermined volume for transporting a corresponding predetermined volume of body fluid to the test area.