Control solution packets and methods for calibrating bodily fluid sampling devices

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.

1 . A control solution packet for use with a pressure-type bodily fluid sampling device having a piercing member, comprising:
 a container having at least a portion that is permeable by the piercing member of the bodily fluid sampling device; and   a control solution sealed within the container, the control solution being adapted to calibrate the bodily fluid sampling device, the control solution being pressurized to force at least some of the control solution into the bodily fluid sampling device when the device pierces the container.   
     
     
         2 . The control solution packet of  claim 1 , wherein the container includes a capsule permeable by the piercing member of the bodily fluid sampling device. 
     
     
         3 . The control solution packet of  claim 2 , wherein the container further includes a membrane provided around the capsule to seal around the piercing member during piercing by the piercing member. 
     
     
         4 . The control solution packet of  claim 2 , further comprising a porous material contained in the capsule for controlling penetration depth of the piercing member. 
     
     
         5 . The control solution packet of  claim 2 , wherein the capsule has a wall with a thickness of about 0.1 mm to about 10 mm. 
     
     
         6 . The control solution packet of  claim 1 , wherein the portion of the container that is permeable by the piercing member includes a membrane to prevent leakage of the control solution around the piercing member. 
     
     
         7 . The control solution packet of  claim 6 , wherein the membrane has a thickness of about 0.0005 mm to about 10 mm. 
     
     
         8 . The control solution packet of  claim 6 , wherein the membrane includes silicon tape. 
     
     
         9 . The control solution packet of  claim 6 , further comprising a sponge-foam material provided within the container to regulate delivery of the control solution to the bodily fluid sampling device. 
     
     
         10 . The control solution packet of  claim 1 , wherein:
 the container defines an opening; and   the portion of the container that is permeable by the piercing member includes a membrane covering and sealing the opening.   
     
     
         11 . The control solution packet of  claim 1 , wherein the control solution has a viscosity to limit delivery of excess amounts of the control solution to the bodily fluid sampling device. 
     
     
         12 . The control solution packet of  claim 11 , wherein the viscosity of the control solution is between about 250 centipoise and about 25,000 centipoise. 
     
     
         13 . The control solution packet of  claim 11 , wherein the control solution includes up to about 10% alginic acid to increase the viscosity of the control solution. 
     
     
         14 . The control solution packet of  claim 1 , wherein the control solution includes up to about 1% to about 5% alginic acid. 
     
     
         15 . The control solution packet of  claim 1 , wherein the control solution packet has a cavity wall with a height of about 0.1 mm to about 10 cm to ensure single sided penetration of the control packet solution by the piercing member. 
     
     
         16 . The control solution packet of  claim 1 , wherein the container is made of polyvinyl chloride. 
     
     
         17 . A calibration system for use with a pressure-type bodily fluid sampling device having a piercing device, comprising:
 a container;   a membrane covering at least part of the container, wherein the membrane is permeable by the piercing device of the bodily fluid sampling device; and   a pressurized fluid contained within the container for calibrating the bodily sampling device.   
     
     
         18 . The calibration system of  claim 17 , further comprising a sponge-like material contained within the container. 
     
     
         19 . The calibration system of  claim 17 , further comprising the bodily sampling device having the piercing device. 
     
     
         20 . The calibration system of  claim 19 , wherein the piercing device includes a needle. 
     
     
         21 . The calibration system of  claim 19 , wherein:
 the bodily sampling device has a test area in which a property of the fluid is determined; and   the fluid has a viscosity to minimize flooding of the test area with the fluid.   
     
     
         22 . The calibration system of  claim 19 , wherein:
 the piercing device has a maximum penetration depth; and   the container has a depth greater than the penetration depth of the piercing device.   
     
     
         23 . A method of calibrating a bodily fluid sampling device having a piercing device, comprising:
 providing a pressurized control solution within a permeable packet;   placing the bodily fluid sampling device against the permeable packet;   piercing the packet with the piercing device;   collecting in the bodily fluid sampling device a sample of the control solution from the packet;   reading a value for the sample of the control solution with the bodily fluid sampling device; and   removing the piercing device from the packet.   
     
     
         24 . The method of  claim 23 , wherein the removing occurs after the reading. 
     
     
         25 . The method of  claim 23 , wherein the removing occurs before the reading. 
     
     
         26 . The method of  claim 23 , wherein the providing the pressurized control solution includes compressing the packet with the bodily fluid sampling device to pressurize the control solution in the packet. 
     
     
         27 . The method of  claim 23 , wherein the providing the pressurized control solution includes providing the packet with the control solution already pressurized before the placing of the bodily fluid sampling device against the permeable packet. 
     
     
         28 . 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.   
     
     
         29 . The apparatus of  claim 28 , 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.   
     
     
         30 . The apparatus of  claim 28 , 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.   
     
     
         31 . The apparatus of  claim 30 , wherein the coupling portion includes a cylindrical tube. 
     
     
         32 . The apparatus of  claim 30 , 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.   
     
     
         33 . The apparatus of  claim 30 , 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.   
     
     
         34 . The apparatus of  claim 30 , 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 device. 
     
     
         35 . 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.   
     
     
         36 . The method of  claim 35 , wherein:
 the container includes a permeable packet containing the control fluid;   the bodily fluid sampling device includes a piercing device; and   the placing the bodily fluid sampling device in contact with the container includes piercing the packet with the piercing device.   
     
     
         37 . The method of  claim 36 , wherein the placing the bodily fluid sampling device in contact with the container further includes pressing the bodily fluid sampling device against the packet to pressurize the control fluid in the packet. 
     
     
         38 . The method of  claim 36 , further comprising providing the control fluid in the packet in a pressurized state. 
     
     
         39 . The method of  claim 36 , wherein the transferring the sample of the control fluid includes passing the sample from the container to the test area via the piercing device. 
     
     
         40 . The method of  claim 35 , 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.   
     
     
         41 . The method of  claim 40 , 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.   
     
     
         42 . The method of  claim 35 , 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. 
     
     
         43 . The method of  claim 42 , 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.   
     
     
         44 . Method for calibrating a body fluid testing device with the steps of
 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 (membrane or foam)   sampling control fluid from the container by said sampling device.   
     
     
         45 . Method according to  claim 44 , wherein said sampling device is a cannula. 
     
     
         46 . Method according to  claim 44 , wherein said sampling device is a pad. 
     
     
         47 . Method according to  claim 44 , wherein said method for calibration employs the same steps in the same order as a method for testing body fluid with said body fluid testing device. 
     
     
         48 . Kit for testing body fluid including a calibration, 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 either has a membrane to be pierced by said piercing device or a porous material for holding calibration fluid.