Device and kit for calibrating bodily fluid sampling devices

• US 8,066,958 B2
• Filed: 05/24/2007
• Issued: 11/29/2011
• Est. Priority Date: 06/08/2001
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Rasch-Menges, Juergen, Jansen, Paul
• Primary Examiner(s): Soderquist; Arlen
• Application Number:
  US11/753,217
• Publication Number:
  US 20070239068A1
• Time in Patent Office: 1,650 Days
• Field of Search: 422/61, 422/430, 422/500, 422/558, 436/8, 436 11- 16, 436/19, 401/23, 401/130, 401/139, 401/202, 401/207, 401/262, 118/264, 118/270, 15/972, 152/441, 152/444
• US Class Current: 422/430
• 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 porous material;

a control solution bottle configured to hold an amount of control solution, the control solution being adapted to calibrate the bodily fluid sampling device;

a coupling portion adapted to couple to the 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, the collection portion has walls that define a collection cavity in which the control solution is collected, the walls of the collection portion are compressible for delivering 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, 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 coupling portion includes a cylindrical tube.

3. The apparatus of claim 1, further comprising:

an inlet check valve provided between the coupling portion and the collection portion to minimize back flow of the control solution into the bottle; and

an outlet check valve provided between the collection portion and the dispensing portion to minimize back flow of the control solution into the collection portion.

4. The apparatus of claim 1, wherein the dispensing portion has a contact edge and a portion of the porous material extends above the contact edge to control the amount of the control solution delivered to the bodily fluid sampling device.

5. 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 porous material for holding calibration fluid;

a container that contains a control fluid, wherein the container includes a dosing attachment, the dosing attachment including a coupling portion, a collection portion, and a dispensing portion;

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

wherein the collection portion is 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, the collection portion has walls that define a collection cavity in which the control fluid is collected, the walls of the collection portion are compressible for delivering the control fluid to the porous material; and

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

6. The kit according to claim 5, wherein the coupling portion includes a cylindrical tube.

7. The kit according to claim 5, further comprising:

an inlet check valve provided between the coupling portion and the collection portion to minimize back flow of the control fluid into the bottle; and

an outlet check valve provided between the collection portion and the dispensing portion to minimize back flow of the control fluid into the collection portion.

8. The kit according to claim 5, wherein the dispensing portion has a contact edge and a portion of the porous material extends above the contact edge to control the amount of the control fluid delivered to the bodily fluid sampling testing device.