Integrated Sample Acquisition and Analyte Measurement Device

• US 20080027302A1
• Filed: 07/30/2007
• Published: 01/31/2008
• Est. Priority Date: 06/27/2000
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Buse, John, Moses, Alan
• Granted Patent: US 8,795,176 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• 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: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

Claims

1. An integrated sample acquisition and analyte measurement device, comprising a housing having an aperture defined therein and having contained therein:

(i) a skin piercing member extendable to the edge or out of the aperture to pierce the skin of a user and retract to cause blood to flow so that it can be collected;

(ii) a removable sensor; and

(iii) a skin piercing member retraction mechanism.

2. The device of claim 1, further comprising a sensor guide.

3. The device of claim 1, wherein the sensor is disposed to collect blood from a pierced site through the aperture without moving the device.

4. The device of claim 1, further comprising a sensor guide.

5. The device of claim 1, wherein the skin piercing member comprises a flat lancet.

6. The device of claim 5, wherein the flat lancet is mounted together with the removable sensor.

7. The device of claim 6, wherein the long dimension of the flat lancet is disposed substantially perpendicular to a surface of the sensor upon which the flat lancet is mounted.

8. A method of determining a concentration of glucose in blood, comprising:

(a) stimulating a region of skin other than the fingertips for at least 1 second;

(b) after stimulating the region of skin, creating an opening in the region of skin to obtain a blood sample from the region by contacting the region of skin with a portion of a housing having an aperture defined therein, wherein the housing contains each of;

(i) a skin piercing member extendable to the edge or out of the aperture to pierce the skin of a user and retract to cause blood to flow so that it can be collected;

(ii) a removable sensor; and

(iii) a skin piercing member retraction mechanism; and

(c) contacting the removable sensor to the blood sample;

(d) transporting no more than 1 microliter of blood sample to the sensor; and

(e) determining the concentration of glucose in the blood sample using the sensor.

9. The method of claim 8, wherein the creating of an opening in the region of skin comprises lancing the region of skin.

10. The method of claim 8, wherein the stimulating of the region of skin comprises rubbing the region of skin.

11. The method of claim 10, wherein the rubbing of the region of skin comprises rubbing the region of skin for at least two seconds.

12. The method of claim 8, wherein the stimulating of the region of skin comprises manually rubbing the region of skin.

13. The method of claim 8, wherein the stimulating of the region of skin comprises mechanically rubbing the region of skin.

14. The method of claim 8, wherein the transporting of no more than 1 microliter of blood sample to the sensor strip comprises transporting no more than 1 microliter of blood sample into a sample chamber of the sensor strip.

15. The method of claim 8, wherein the transporting of no more than 1 microliter of blood sample to the sensor strip comprises transporting no more than 0.5 microliter of blood sample to the sensor.

16. The method of claim 8, wherein the transporting of no more than 1 microliter of blood sample to the sensor comprises transporting no more than 0.25 microliter of blood sample to the sensor.

17. An integrated sample acquisition and analyte measurement device to determine a concentration of glucose in blood, comprising:

(a) means for stimulating a region of skin other than the fingertips for at least 1 second;

(b) means for creating an opening in the region of skin to obtain a blood sample from the region by contacting the region of skin with a portion of a housing having a skin piercing member extended to the edge of out of an aperture defined in the housing portion, wherein the housing further contains each of a removable sensor and a skin piercing member retraction mechanism;

(c) means for contacting the removable sensor to the blood sample, whereby no more than 1 microliter of blood sample is transported to the sensor; and

(e) means for determining the concentration of glucose in the blood sample using the sensor.

18. The device of claim 17, wherein the means for stimulating of the region of skin comprises means for rubbing the region of skin.

19. The device of claim 17, wherein the means for stimulating of the region of skin comprises means for manually rubbing the region of skin.

20. The device of claim 17, wherein the means for stimulating of the region of skin comprises means for mechanically rubbing the region of skin.