# US 8,772,034 B2 · Control solution packets and methods for calibrating bodily fluid sampling devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,772,034 B2 - Document ID: US8772034B2 - Status: Granted - Kind: B2 - Application number: 13/279,560 - Filed: 2011-10-24 - Published: 2012-02-16 - Granted: 2014-07-08 - Earliest claimed: 2002-06-10 - Assignees: Roche Diagnostics Operations, Inc. - Applicants: Juergen Rasch-Menges; Paul Jansen - Inventors: Juergen Rasch-Menges; Paul Jansen - Web page: https://patentgrep.com/patent/US8772034B2 ## CPC - A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood - A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/150358: {Strips for collecting blood, e.g. absorbent} - A61B 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)} - A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)} - A61B 5/15144: {comprising driving means, e.g. a spring, for retracting the piercing unit into the housing} - A61B 5/1519: {comprising driving means, e.g. a spring, for propelling the piercing unit} - 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} - A61B 5/150175: {Adjustment of penetration depth} - A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 - Y10T 436/10: Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing - Y10T 436/102499: Blood gas standard or control - Y10T 436/103332: Bilirubin or uric acid standard or control - Y10T 436/104165: Lipid, cholesterol, or triglyceride standard or control - Y10T 436/104998: Glucose, ketone, nitrate standard or control - Y10T 436/105831: Protein or peptide standard or control [e.g., hemoglobin, etc.] - Y10T 436/106664: Blood serum or blood plasma standard or control - Y10T 436/109163: Inorganic standards or controls - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## 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 ### Claim 1 An apparatus for calibrating a bodily fluid sampling device, comprising: a bodily fluid sampling device configured to receive a sample of bodily fluid under pressure, the bodily fluid sampling device having a piercing member; a first layer configured to form a sealed packet: a second layer that surrounds and contacts the first layer; a pressurized control solution provided in the sealed packet, the control solution being adapted to calibrate the bodily fluid sampling device; and wherein a sample of the pressurized control solution is expelled through a bodily fluid flow path in the bodily fluid sampling device as the piercing member pierces the first and second layers to create an opening, the second layer configured to form a seal around the piercing member to prevent leakage of the control solution from the sealed packet. ### Claim 2 (depends on 1) The apparatus of claim 1, further comprising: a porous material is sealed inside the packet; the first layer and the second layer each have at least a portion that is permeable by the piercing member of the bodily fluid sampling device. ### Claim 3 A method of calibrating a bodily fluid sampling device, comprising: providing a sealed container that contains a pressurized control fluid, the sealed container having an inner wall configured to contain the control fluid and an outer wall that surrounds and contacts the inner wall; placing the bodily fluid sampling device having a piercing device in contact with the sealed container that contains the pressurized control fluid; piercing the inner and outer walls of the container with the piercing device to create an opening in both the inner and outer walls, the outer wall configured to form a seal around the piercing device to prevent leakage of the control fluid from the container; expelling a sample of the pressurized control fluid from the container through a bodily fluid flow path in the bodily fluid sampling device 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. ### Claim 4 (depends on 3) The method of claim 3, 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 container to increase the pressure of the control fluid. ### Claim 5 (depends on 3) The method of claim 3, wherein the expelling 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. ### Claim 6 (depends on 5) The method of claim 5, wherein: 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. ### Claim 7 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 packet having a first layer that surrounds and encloses a porous material wetted with a pressurized control fluid therein, the packet having a second layer that surrounds and encloses the first layer; actuating said piercing device to pierce the first and second layers of the packet to create an opening in both the first and second layers of the packet, the second layer configured to form a seal around the piercing device to prevent leakage of the control fluid from the packet, said piercing device piercing the porous material; and sampling the pressurized control fluid from the packet by capillary action into said sampling device. ### Claim 8 (depends on 7) The method according to claim 7, wherein said sampling device is a cannula. ### Claim 9 (depends on 7) The method according to claim 7, wherein said sampling device is a pad. ### Claim 10 (depends on 7) The method according to claim 7, wherein said actuating occurs first and said sampling occurs second and in the same order as a method for testing body fluid with said body fluid testing device. ### Claim 11 (depends on 7) The method according to claim 7, further comprising: stopping the piercing device in the porous material to prevent the piercing device from creating a second opening in the packet. ### Claim 12 (depends on 7) The method according to claim 7, further comprising: pressing the body fluid testing device against the porous material to increase the pressure of the control fluid. ### Claim 13 A kit for testing body fluid, comprising: a body fluid testing device having a piercing device located inside 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, said housing having a wall that defines a capillary space that surrounds a piercing tip of said piercing device, wherein the capillary space is configured to draw fluid via capillary action; and a container having a first wall that contains and seals a pressurized control fluid therein and which has a porous material therein for holding the control fluid in the container, the container having a second wall that surrounds the first wall, the first and second walls each having a portion that is permeable by the piercing device of the body fluid testing device, the second wall further configured to form a seal around the piercing device to prevent leakage of the control fluid from the container. ### Claim 14 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; an inlet check valve provided between the coupling portion and the collection portion to minimize back flow of the control solution into the bottle; a dispensing portion fluidly coupled to the collection portion, the dispensing portion defining a cavity in which the porous material is received; 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. ### Claim 15 (depends on 14) The apparatus according to claim 14, 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. ### Claim 16 (depends on 3) The method of claim 3, wherein: the pressure of the control fluid in the container is from above 0 psig to about 20 psig prior to contact of the bodily fluid sampling device.