Methods and apparatus for sampling and analyzing body fluid

• US 7,727,168 B2
• Filed: 06/19/2007
• Issued: 06/01/2010
• 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: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US11/765,045
• Publication Number:
  US 20070293747A1
• Time in Patent Office: 1,078 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
• 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 collecting a bodily fluid sample from an incision in skin comprising:

forming the incision in the skin with a needle of a bodily fluid sampling device;

pressing against the skin a stimulator sleeve of the bodily fluid sampling device around the incision to express the bodily fluid sample;

moving a capillary tube of the bodily fluid sampling device towards the incision by moving the capillary tube relative to the stimulator sleeve while the sleeve remains in contact with the skin;

drawing the bodily fluid sample from the incision into the capillary tube via capillary action;

wherein the needle and the capillary tube are distinct components;

wherein said forming the incision in the skin includes

extending the needle towards the skin to form the incision, and

retracting the needle from the incision;

wherein said moving the capillary tube of the bodily fluid sampling device towards the incision occurs after said retracting the needle from the incision;

wherein said drawing the bodily fluid sample from the incision into the capillary tube occurs after said moving the capillary tube of the bodily fluid sampling device towards the incision; and

wherein said drawing the bodily fluid sample from the incision into the capillary tube includes collecting the bodily fluid sample on the surface of the skin.

2. The method of claim 1, further comprising transferring the bodily fluid onto a test strip located at one end of the capillary tube.

3. The method of claim 2, further comprising analyzing the bodily fluid with the test strip.

4. The method of claim 3, further comprising:

wherein the needle, the capillary tube and the test strip are integrated together in a first disposable;

removing the first disposable from the bodily fluid sampling device after said drawing the bodily fluid sample from the incision into the capillary tube;

disposing of the first disposable; and

loading a second disposable into the bodily fluid sampling device after said removing the first disposable from the bodily fluid sampling device.

5. A method of collecting a bodily fluid sample from an incision in skin comprising:

forming the incision in the skin with a needle of a bodily fluid sampling device;

pressing against the skin a stimulator sleeve of the bodily fluid sampling device around the incision to express the bodily fluid sample;

moving a capillary tube of the bodily fluid sampling device towards the incision by

moving the capillary tube relative to the stimulator sleeve while the sleeve remains in contact with the skin;

drawing the bodily fluid sample from the incision into the capillary tube via capillary action;

wherein the needle and the capillary tube are distinct components;

wherein the needle and the capillary tube are integrated together in a first disposable;

removing the first disposable from the bodily fluid sampling device after said drawing the bodily fluid sample from the incision into the capillary tube;

disposing of the first disposable; and

loading a second disposable into the bodily fluid sampling device after said removing the first disposable from the bodily fluid sampling device.

6. The method of claim 5, further comprising transferring the bodily fluid onto a test strip located at one end of the capillary tube.

7. The method of claim 6, further comprising analyzing the bodily fluid on the test strip.

8. The method of claim 7, wherein the analyzing the bodily fluid on the test strip includes an optical analyzing mechanism.

9. The method of claim 7, wherein the analyzing the bodily fluid on the test strip includes an electrochemical mechanism.

10. The method of claim 6, further comprising:

wherein the capillary tube includes a head and an absorbent pad; and

wherein the absorbent pad is disposed between the test strip and the head of the capillary tube.

11. The method of claim 10, wherein the head defines an air vent opening to relieve pressure.

12. A method of collecting a bodily fluid sample from an incision in skin, comprising:

pressing against the skin a bodily fluid sampling device housing a first disposable that includes a skin-lancing member, chemicals for analyzing the bodily fluid sample, and a capillary passage with a capillary passage opening, wherein the skin-lancing member and the capillary passage are distinct components;

cutting the incision in the skin with the skin-lancing member of the first disposable by firing the skin-lancing member and the capillary passage of the first disposable as a single unit towards the skin;

retracting the skin-lancing member and the capillary passage of the first disposable as a single unit off the skin;

collecting via capillary action from the incision the bodily fluid sample on the surface of the skin with the capillary passage by extending the passage opening of the capillary passage past the skin-lancing member;

analyzing the bodily fluid sample with the chemicals of the first disposable;

disposing of the first disposable; and

loading a second disposable into the bodily fluid sampling device after said disposing of the first disposable.

13. The method of claim 12, wherein said collecting includes venting air from the capillary passage via a vent as the bodily fluid sample fills the capillary passage.

14. The method of claim 12, wherein said analyzing the bodily fluid sample includes optical analysis.

15. The method of claim 12, wherein said analyzing the bodily fluid sample includes electrochemical analysis.

16. The method of claim 12, wherein the capillary passage is located inside a capillary tube.

17. The method of claim 12, wherein the chemicals for analyzing the bodily fluid samples. part of a test strip.