CONTROL SOLUTION PACKETS AND METHODS FOR CALIBRATING BODILY FLUID SAMPLING DEVICES

• US 20120041341A1
• Filed: 10/24/2011
• Published: 02/16/2012
• Est. Priority Date: 06/08/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Rasch-Menges, Juergen, Jansen, Paul
• Granted Patent: US 8,772,034 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150175 Adjustment of penetration depth
• 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 5/150503 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 5/1519 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
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/104165 Lipid, cholesterol, or triglyceride standard or control
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/109163 Inorganic standards or controls

Abstract

A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Claims

1. An apparatus for calibrating a bodily fluid sampling device, comprising:

a container;

a porous material provided in the container;

a control solution provided in the porous material, the control solution being adapted to calibrate the bodily fluid sampling device; and

wherein the porous material is compressible to pressurize the control solution and dispense the control solution to the bodily fluid sampling device when the porous material is compressed.

2. The apparatus of claim 1, wherein:

the porous material is sealed inside the container; and

the container has at least a portion that is permeable by a piercing member of the bodily fluid sampling device.

3. The apparatus of claim 1, wherein the container includes a dosing attachment, the dosing attachment including:

a coupling portion adapted to couple to a control solution bottle and receive the control solution from the bottle;

a collection portion fluidly coupled to the coupling portion, the collection portion being adapted to collect the control solution from the bottle and deliver the control solution to the porous material; and

a dispensing portion fluidly coupled to the collection portion, the dispensing portion defining a cavity in which the porous material is received.

4. The apparatus of claim 3, wherein:

the collection portion has walls that define a collection cavity in which the control solution is collected; and

the walls of the collection portion are compressible for delivering the control solution to the porous material.

5. A method of calibrating a bodily fluid sampling device, comprising:

placing the bodily fluid sampling device in contact with a container that contains a control fluid;

transferring a sample of the control fluid from the container to a test area inside the bodily fluid sampling device; and

reading a value for the sample of the control fluid in the test area with the bodily fluid sampling device.

6. The method of claim 5, wherein:

the container houses a porous material wetted with the control fluid; and

the placing the bodily fluid sampling device in contact with the container includes pressing the bodily fluid sampling device against the porous material.

7. The method of claim 6, further comprising:

coupling the container to a control solution bottle that contains the control fluid, wherein the container includes a dosing attachment that includes a collection portion with a collection cavity fluidly coupled between the control solution bottle and the porous material;

delivering the control fluid from the control solution bottle to the collection cavity; and

wetting the porous material with the control fluid by compressing the collection portion.

8. The method of claim 5, wherein the transferring the sample of the control fluid includes moving the sample of the control fluid through the bodily fluid sampling device along the same flow path through which the bodily fluid sampling device collects bodily fluid.

9. The method of claim 8, wherein:

the bodily fluid sampling device includes a piercing device; and

the moving the sample of the control fluid through the bodily fluid sampling device includes collecting the sample of the control fluid with the piercing device.

10. A method for calibrating a body fluid testing device, comprising:

providing a body fluid testing device having a piercing device and a device for sampling fluid to be tested, wherein said piercing device and said device for sampling fluid to be tested are integrated into a housing;

providing a container that contains a control fluid;

actuating said piercing device to pierce a portion of the container; and

sampling control fluid from the container by said sampling device.

11. The method according to claim 10, wherein said sampling device is a cannula.

12. The method according to claim 10, wherein said sampling device is a pad.

13. The method according to claim 10, wherein said actuating and said sampling occur in the same order as a method for testing body fluid with said body fluid testing device.

14. The method according to claim 10, wherein:

the container includes a porous material; and

said actuating includes piercing the porous material.

15. The method according to claim 10, further comprising:

wherein the container houses a porous material wetted with the control fluid; and

pressing the body fluid testing device against the porous material.

16. The method of claim 15, further comprising:

coupling the container to a control solution bottle that contains the control fluid, wherein the container includes a dosing attachment that includes a collection portion with a collection cavity fluidly coupled between the control solution bottle and the porous material;

delivering the control fluid from the control solution bottle to the collection cavity; and

wetting the porous material with the control fluid by compressing the collection portion.

17. A kit for testing body fluid, comprising:

a body fluid testing device having a piercing device and a device for sampling fluid to be tested, wherein said piercing device and said device for sampling fluid to be tested are integrated into a housing,

a container that contains a control fluid and which has a porous material for holding calibration fluid.

18. The kit according to claim 17, wherein:

the porous material is sealed inside the container; and

the container has at least a portion that is permeable by the piercing device of the body fluid testing device.

19. The kit according to claim 17, wherein the container includes a dosing attachment, the dosing attachment including:

a coupling portion adapted to couple to a control fluid bottle and receive the control fluid from the bottle;

a collection portion fluidly coupled to the coupling portion, the collection portion being adapted to collect the control fluid from the bottle and deliver the control fluid to the porous material; and

a dispensing portion fluidly coupled to the collection portion, the dispensing portion defining a cavity in which the porous material is received.

20. The kit according to claim 19, wherein:

the collection portion has walls that define a collection cavity in which the control fluid is collected; and

the walls of the collection portion are compressible for delivering the control fluid to the porous material.