KR20050018651A - Integrated sample testing meter - Google Patents

Abstract

By way of example, the integrated sample test meter of the present invention for blood measurement includes puncture means, sensors and test strip cartridges disposed in a single modular housing. The test strip cartridge includes a stack of test strips suitable for performing electrochemical or photometric analysis of blood samples. The integrated test system automatically dispenses, locates and forms the puncture position of the test strip. Blood is transferred from the punctured position to the test strip, and the sensor automatically analyzes the blood sample after the test strip collects the sample from the punctured position.

Description

Integrated sample testing meter

The present invention relates to an integrated sample test meter for use in the sampling and analysis of analytical samples, in particular glucose in blood or interstitial fluid.

Glucose monitoring is a daily routine for individuals with diabetes. The accuracy of such monitoring can literally mean the difference between life and death. In general, diabetics measure blood glucose levels several times a day to monitor and control blood glucose levels. Failure to accurately and accurately measure blood glucose levels can lead to serious diabetes related complications including cardiovascular disease, kidney disease nerve damage and blindness. Many glucose meters are currently available, which allows individuals to test glucose levels in small amounts of blood samples.

Many glucose meter designs currently available use disposable test strips that measure the amount of glucose in the blood sample either electrochemically or photometrically in combination with the meter. To use these meters, a user first drills a finger or a body part thereof using a puncturing means, such as a lancet, to produce a small sample of blood or interstitial fluid. The sample is then delivered to a disposable test strip. The inconvenience of taking several measurements per day and the pain exerted by currently available means of drilling often leads to abandoning regular and frequent tests.

Due to the rich capillary layer of the skin at the fingertips, fingertips are generally used for blood sampling, but the fingertips are also particularly sensitive to pain due to the presence of abundant pain in the fingertips. When the perforation is too deep, recently too close to the perforation, or not deep enough, additional perforation is required, and the pain is significantly increased. It also increases when the puncturing means is punctured too slowly or withdrawn slowly. In addition, the user needs to achieve more punctures than necessary to form a sufficient amount of blood due to loss during delivery between the puncture location and the test strip.

The blood glucose level measurement process requires a number of different accessories and a number of steps, including a puncturing device, a puncturing means, a test strip supply and a glucose meter. Each accessory has a different function. The user needs a flat surface where the accessories can be laid out where they can be easily grasped. This is in itself a problem for those who need to take measurements while participating in outdoor activities. This is a disadvantage because blood glucose levels can change significantly during outdoor activities.

Even if the user can find a flat surface, the user should perform the following steps. The user replaces the puncture device with a new puncture means, opens the strip test tube, removes the strip, inserts the strip into the meter, closes the test tube again, checks the correct calibration code on the meter, holds the puncture device, holds the finger skin Or lancet other body parts, lower the puncture device, squeeze or massage the fingers to produce an appropriate blood sample, pass to the test strip for analysis of the sample, wait for the meter to analyze the sample, and from the test meter Strips should be removed, strips discarded and all accessories finally packed again. As mentioned above, the standard procedure required to take blood glucose measurements requires the use of multiple discrete components and the execution of multiple steps that require manual intervention by the user.

In general, the user needs to deliver a small volume of sample to a sample receiving location on the test strip. In general, the test strip is very small and therefore the sample receiving area is smaller. This delivery step is a difficult task for many users. Also, in recent years there has been a tendency to use test strips that require a smaller amount of sample (which allows the user to use smaller perforations, thus allowing smaller pain perforations). The use of smaller samples increases the difficulty of delivering the sample to the sample receiving area on the test strip. This is particularly difficult for users with weakened vision, a common complication of diabetes.

Pain, discomfort, cost, slow speed, complexity, and segregation taking blood glucose measurements are obstacles to frequent monitoring of glucose levels. Patients often fail to follow the doctor's recommendation to test glucose levels frequently due to the many difficulties involved.

It is an object of the present invention to provide a solution to the above-mentioned problems with minimal pain.

1 is a perspective view of an integrated blood and test meter in accordance with the present invention with the strip in a sample receiving position;

2 is a perspective view of the measuring system of FIG. 1 with the lancet cover in an open position;

3 is a perspective view of the measurement system of FIG. 1 with the subhousing in an open position;

4 is a schematic diagram showing a portion of the interior of a feed channel having a strip in place;

5 illustrates a test strip design suitable for the present invention.

6 is a schematic diagram of an electronic device that may be included in an integrated measurement system in accordance with the present invention.

7 is a cross-sectional view of a cartridge device that may be used in the integrated measurement system according to the present invention.

8 is a cross-sectional view showing another device of a cartridge that can be used in the integrated measuring system according to the present invention.

Thus, in the first aspect, the present invention provides an integrated sample-test measurement system comprising a single modular housing,

The single modular housing,

Drilling means;

A drive train for driving said puncturing means between an extended position and a retracted position;

A test strip cartridge containing a plurality of test strips each having a sample receiving area;

A sensor for analyzing a fluid sample received on the test strip; And

A test strip dispensing system for individually moving the test strip from a cartridge to a sample receiving position to which the test strip is connected to the sensor,

When in use, the measuring system, when placed and operated in a first position on the user's skin, moves the perforation means to its extended position and then contracts to form a perforation in the user's skin, and a test strip is formed from the cartridge. An integrated sample test meter is provided that is arranged to be moved to a receiving position.

In use, after perforation is made, the user moves the measurement system to a second position where the sample receiving area of the test strip is located in the drop and receives the sample from the fluid drop. The sensor then analyzes the sample.

The measuring system of the present invention includes an electric or electronic circuit for controlling its operation. Such circuits may be hard-wired or include microcomputers or similar devices. This circuit includes in particular all the components in the sensor and is arranged to carry out the analysis of the sample.

In addition, the circuit comprises a visual display unit, and it is suitable for the user to be able to read certain specific test results therefrom. In addition, the display may be adapted to provide a display of data, as will be described in more detail below.

The circuit suitably includes means such as a touch-sensitive display, control buttons or microphone and voice activated software for entering data into the measurement system.

The measuring system preferably further comprises a pressurizing device arranged to facilitate the formation of fluid droplets around the perforation.

The pressurization device may comprise a pump adapted to apply a negative pressure to a volume in a measurement system having an opening relative to a location on the user's skin. The part of the measuring system which forms the opening through which the puncturing means extends is made of an anti-slip material, so that it is advantageous that the measuring system can be more firmly positioned on the user's skin during the puncturing operation.

However, the pressurization device comprises a pressurization ring, which pressurization ring is positioned on the user's skin in use to apply pressure to the edge of the ring to increase the amount of fluid available at the center of the ring. The pressing ring is preferably made of an anti-slip material to allow the meter to be more firmly positioned on the user's skin during the drilling operation.

The pressure ring may be shaped to match the shape of the area of the skin to which it is applied. As an example, when a measuring system is used on the forearm, the pressure ring is generally planar. However, when the measuring system is used on the finger, the pressing ring is curved.

The press ring is suitably having a multi-contoured surface for increasing the pressure gradient from outside the ring to the inside.

The pressing ring is advantageously part of a cap covering the puncturing means in its retracted position. The cap suitably includes means such as sidewalls that cooperate with the drive train to ensure that the drilling means travel along substantially the same path in each actuation of the drive train.

The cap is suitably part of a housing. However, the cap may be detachably mounted to the housing. This can be achieved by the use of snap-coupled connections, hinged connections, or screw-screw or bayonet type fastenings.

If desired, the meter may comprise two or more replaceable caps, such as a forearm cap and a finger cap.

The drilling means may be any type of drilling means existing in the prior art. The term "perforation means" includes lancets and finger-sticking devices of the type known in the art. The puncturing means are suitably removably attached to the drive train so that the puncturing means can be discarded after one or several uses.

The drive train is suitably spring driven. Alternatively, the drive train is electromagnetically driven. The drive train is arranged such that during operation the puncturing means moves to an extended position and then contracts.

The drive train comprises an adjusting screw which allows the user to set the extension position of the drilling means. This allows the user to calibrate the operation of the meter so that it is punctured sufficiently to allow his or her skin to form sufficient droplets without causing too much pain.

The operation of the adjusting screw is arranged such that the movement distance of the puncturing means remains constant, but the extension position of the puncturing means is changed. This ensures that the amount of pain experienced by the user does not disproportionately increase in the depth of puncture.

In the case where the meter comprises a cap, as described above, the cap suitably provides a means for guiding the drive train such that the puncturing means punctures the skin at substantially the same position during each operation of the drive train.

The test strip cartridge suitably includes a cartridge housing forming a cavity configured to receive a stack of strips, a partially detachable cartridge cap and a means for moving the stack strip towards the cartridge cap.

The test strips used for some measurements are air- or moisture-sensitive. Thus, the cartridge suitably includes a seal for sealing the cartridge cap against the cartridge housing when the cartridge cap is fully engaged with the cartridge housing. This seal may be on the cartridge cap or on the cartridge housing.

In use, upon operation of the meter, the cartridge cap is partially separated from the cartridge housing to allow the first test strip in the stack to be moved by the test strip dispensing system to the sample receiving position. Once the measurements have been made, it is suitable for the cartridge cap to be manually placed on the cartridge housing to close the cartridge and seal its contents from atmospheric effects.

The cartridge preferably has data on it on the calibration code for the strip in the cartridge. This data may be present as a visually readable indicator. In this case, the measurement system must have a means for allowing a user to enter a calibration code into the measurement system, as described above.

However, it is suitable for the data on the cartridge to be present in a machine readable format, such as a barcode or a resistive bridge circuit, or stored in an electronic memory module.

If the data is provided as a barcode, the measurement system includes a barcode reader. It may be a scanning reader or a fixed reader. Scanning readers are more complex but can be used when the cartridge is stuck to the meter. Fixed readers are less complex, but can only be used when the cartridge is inserted or ejected into the meter.

If data is present in the electronic memory module, it may include read-only memory (ROM) or rewritable memory, eg EPROM or EEPROM.

The data also includes the unique number identifying the designated cartridge, the number of strips originally present in the cartridge, the cartridge effective date, different calibration factors for different fluid sources (eg, neonatal, arterial or venous blood), and acceptable performance ranges. And some other relevant information, preferably in a machine readable format, to assist in the operation of the measurement system.

If the memory module on the cartridge is rewritable, the meter will measure the number of strips used, the date of first cartridge use, the length of time the cartridge remains open, the date, time and result of each test performed on the strip from the cartridge. It may be arranged to write information back to the memory module.

The test strip dispensing system suitably includes a slider adapted to engage with only one of the test strips in the cartridge and move it to the sample receiving position.

The measuring system advantageously includes a feed channel for receiving the strip from the cartridge and guiding it to the sample receiving position.

The feed channel suitably includes a step arranged to prevent the strip from falling off or being pushed into the step as the strip moves past the step so that the strip does not move back toward the cartridge.

The strip is suitably pushed into the step by means of a spring arranged on the meter. The spring is also electrically conductive and advantageously arranged to be in electrical contact with an electrode on the strip or a conductive bar (see below).

Alternatively, the strip may have, for example, a triangular shaped cutout, which mates with a spring biased contact that fits within the cutout to keep the strip in its sample receiving position.

The measuring system advantageously comprises a discharging means for discharging the used test strip from the measuring system after the test is completed. Preferably, where the cartridge comprises a cartridge cap, the ejection means is activated when the cartridge cap is opened.

The measuring system suitably comprises interlock means for preventing the test strip dispensing system from moving the additional test strip to the sample receiving position while the first test strip is still in place. This is advantageous because in some cases one drilling operation is required when adjustment of the drilling depth is required to form a sufficiently large fluid drop, allowing the user to perform one drilling operation with the same strip in place. It is characteristic.

The interlocking means is preferably operated in conjunction with a cartridge cap. While the cartridge cap is partially detached from the cartridge housing, the interlock means block the normal path for a test strip dispensing system such as a slider to introduce the cartridge cap into the cartridge cap rather than the normal path.

The interlocking means may also comprise a separate knob for cocking the puncturing means for dispensing the strip independently from the cartridge.

The meter includes means for confirming that the strip is in the sample receiving position. This may include a reflectometer. Typically the test strip has a higher or lower reflectance than the surface of the supply channel. Thus, the reflectance indicates whether the test strip is in place.

However, it is suitable for the identification means to include an electrical system. In its simplest form, each strip has a conductive bar arranged thereon to short the two electrodes of the meter. This arrangement is useful for strips arranged to make photometric measurements.

The strip already arranged to make electrochemical measurements already comprises an electrode system. Thus, the identification system may include an electrical contact on the measurement system that contacts the electrodes on the strip. As mentioned above, the electrical contacts on the measurement system are preferably spring loaded and advantageously arranged to push the strip into the step in the feed channel.

It is advantageously also possible for the verification means to be used to fully operate the circuit in the measuring system. The measuring system is in a low power mode in which only the active circuit in the steady state is used to control the verification means. After the verification means indicate that the strip is provided, the measuring system then automatically switches to the high power mode in which all of its associated circuits will function.

The checking means is also preferably arranged to start a timer in the circuit of the measuring system. The timer is stopped by the discharge of the used strip from the meter, preferably by closing the cartridge cap. This allows the circuit to determine the length of time the cartridge has been open in the atmosphere. The circuit is advantageously arranged to add up the total time the cartridge has been opened and to generate an alarm signal, such as an audible acoustic or visual signal, when the total exceeds a preset maximum.

The circuit in the metering system also advantageously counts the number of strips dispensed from each cartridge. The circuit is advantageously designed to generate an alarm signal such as an audible acoustic or visual signal when the number of strips remaining in the cartridge is small.

If the cartridge has data on the permissible performance range thereon, it is advantageous for the circuit to be arranged such that the measurement system is disabled while the cartridge is in the measurement system, in which case the control test provides results outside the performance range. This arrangement ensures that if the strips in a particular cartridge are degraded they will not be used.

As mentioned above, the cartridge comprises a rewritable memory module, and the circuitry in the meter is suitably arranged to reply to the cartridge memory module useful information such as the number of remaining strips in the cartridge and the length of time the cartridge has been open in the atmosphere. Do. The rewrite function is particularly useful when the user is likely to be out of its normal environment for a length of time that requires the use of more strips than are present in the cartridge. In this case, the user can remove the old cartridge and insert a new complete cartridge. After the new cartridge is used, the user can insert the old cartridge even if it is old. As long as the meter can read the data on the old cartridge, it can determine that the old cartridge can be used.

In addition, the provision of a rewritable memory module enables other possible uses. By way of example, data and measurement results for the time and date of use may be recorded in the memory module of the cartridge. The used cartridge is then returned to the user's health manager, who can then study the data to determine whether the user complies with the treatment and monitor the condition. Alternatively, the used cartridge may be returned to the manufacturer to allow general research of the use performed. These data illustrating the effective use of the strips may provide a health manager's tool for confirming the actual use of the strip in which they have been strained.

The measuring system is suitably operated manually by the use of a single movement of the multifunctional assembly, for example carried out by the housing. The assembly may include a lever pivoted to the housing. However, the assembly suitably includes a sliding knob that cocks the drive train and slides to move the strip to the sample receiving position.

Movement of the assembly may also activate the circuitry of all measurement systems.

The drive train can be triggered by further movement of the lever, or preferably by actuation of the trigger.

Thus, the use of the integrated sample testing meter of the present invention can be seen very simply. If necessary, the user can replace the existing drilling means with a new one. At this time, the measuring system is caulked by use of the assembly. This also moves the strip to the sample receiving position. The movement of the lever or the reception of the strip in the sample receiving position also activates the circuit of all measuring systems. The user then places an appropriate portion of the meter, such as an opening or cap, on his or her skin and activates the trigger.

If the first actuation of the trigger does not lead to the formation of a sufficiently large fluid drop, the measuring system can be caulked, placed and triggered once more without the need to insert a new strip.

Once enough fluid has accumulated around the perforation, the user moves the measurement system to the second position, where the strip is placed in the drop, and the sample receiving position takes a sample of the fluid.

Thus, the use of the measurement system of the present invention avoids most of the steps currently required, and in particular makes it possible to avoid steps in which agility and good vision of manual manipulation are useful.

The measuring system is suitably used to generate and analyze a sample of blood or interstitial fluid, in particular to analyze the blood sample for blood glucose levels. Strips used to make such measurements are well known in the art. These may be electrochemical or photometric strips.

The strip is suitably adapted to perform electrochemical analysis, and the circuitry in the measuring system is suitably arranged to be in contact with the electrodes in this strip.

Thus, in a preferred embodiment, the present invention provides an integrated blood glucose test meter. The integrated meter of this aspect of the present invention enables a simple, one-step blood glucose monitoring process and significantly reduces the obstacles associated with frequent glucose monitoring. The integrated measuring system provides automatic dispensing and placement of test strips and user drilling in a repeatable manner. After user-initiated delivery of the test strip of the blood sample, an automatic analysis of the blood sample is made.

According to yet another aspect of the present invention, an integrated method for sampling and testing blood glucose levels or other analytes in a body fluid is provided. The integrated method includes mounting a test strip cartridge into an integrated test meter, operating an assembly on the test meter to cock the puncturing means drive train and move the test strip to a sample receiving position, and to use the integrated test meter. Pressing on the skin of the step of pressing the trigger of the test meter to drive the puncturing means into the skin to form a drop of blood or other fluid on the skin surface. The user moves the measurement system so that the test strip can absorb the amount of blood or other fluid needed for automated analysis of the integrated test measurement system.

According to another feature of the invention, there is provided a cartridge for holding and dispensing a test strip, the cartridge comprising:

A housing having an opening for containing a test strip;

A lid adapted to join a test strip from the housing and slidably attached to the housing;

A seal for sealing the opening;

In the first position the cover closes the opening and engages with the seal, in the second position the cover is released from the seal and in combination with the test strip in the housing, thus from the second position the first position Movement of the furnace releases the test strip from the housing.

Thus, unsealing the lid from the housing, dispensing the strip from the housing, and resealing the housing can be reliably accomplished in a two step movement of the lid. There is no need for a separate cover and strip dispenser. The operation of the lid and thus the step of sealing-dispensing-resealing can be accomplished in a single size of motion.

Preferably, the lid has a sliding surface in parallel to the mating surface of the housing at the edge of the opening.

Preferably, the sliding surface has a step for joining a test strip.

The step allows the top test strip from the stack of test strips in the housing to be obtained from the housing and pressed outward.

In one embodiment of the invention, at least one portion of the sliding surface is inclined with respect to the engagement surface such that the sliding of the lid from the first position to the second position releases the lid from the seal. The sliding surface acts as a ramp against the mating surface of the housing such that the lid is pressed away from the seal as it slides open. Deflection means on the measurement system in which the cartridge is disposed maintains the seal between the lid and the housing in a closed position and also maintains a sliding surface that is pressed against the mating surface when the lid is slipped to the open position. Deflect the lid against.

In another embodiment of the invention, the cartridge also includes a reference surface that is attached to the housing in which the lid is slipped and at least one portion is inclined with respect to the mating surface of the opening edge. The reference surface also acts as a lamp against the sliding surface of the lid.

Preferably, there is a strip deflecting means in the housing to deflect the test strips contained in the housing relative to the sliding surface. For example, the strip biasing means may be a helical spring or a spring of constant force.

Preferably, there is cover deflection means for deflecting the cover relative to the seal in the first position. The cover biasing means may be a leaf spring. In one embodiment, the lid biasing means is integral with the cartridge. Alternatively, the cover biasing means can be fixed to the measurement system.

Preferably, the cartridge comprises a dry material in the housing. In this way, moisture entering the housing can be absorbed, which is important to keep the test strip in good condition. Such material may be formed into a liner in the housing.

In one embodiment of the invention, the cartridge comprises identification means for holding data with respect to the test strip in the housing.

Preferably, the recognition means is a readable and writable electronic memory chip.

The memory chip may be accessed by a measurement system in which a cartridge is located or any other device is suitably employed for the same purpose.

In another feature of the invention, a method is provided for dispensing a test strip from a cartridge housing, the method comprising:

Sliding the lid from a first position in which the lid closes the opening in the housing and engages the seal around the opening, from the seal to a second position where the lid is released from the seal and engaged with the test strip in the housing;

By sliding the lid from the second position to the first position, the joined test strip is pressed out of the housing by the lid.

The above and other features and advantages of the present invention will be better understood with reference to the following detailed description in conjunction with the accompanying drawings, in which like reference characters designate like elements.

The present invention provides an integrated measurement system for sampling and analyzing samples of body fluids, such as blood, comprising a disposable test strip cartridge having a stack of test strips disposed therein. The present invention facilitates the monitoring of blood glucose levels by, for example, integrating the steps involved in blood sampling and analysis into a single meter in a simple process using a single meter.

The invention is described below with respect to exemplary embodiments. Those skilled in the art will appreciate that the present invention can be implemented in many other applications and embodiments, and its use is not limited to the specific embodiments described herein.

Although those skilled in the art can also be used to analyze other types of fluids, the present invention is described below in connection with blood sampling.

1-3 illustrate an integrated blood glucose sampling and test meter 10 according to an exemplary embodiment of the present invention. This meter is designed to perform electrochemical analysis of blood samples. However, the same mechanical component can be used in conjunction with photometric analysis if desired. The sampling and test measurement system includes a modular housing 11 that surrounds the integrated system for extruding and subsequent analysis of the sample. The meter 10 includes an assembly for puncturing the skin of the user to extrude a drop of blood on the surface of the skin. The assembly comprises a lancet 13 as a puncturing means and a drive train 14 for driving the lancet into and out of the skin.

A transparent cap 16 is attached to the housing 11 by a hinge at the proximal end of the device 10. The housing 11 includes a recess 17 that allows the cap 16 to be moved to the open position shown in FIG. 2. In this position, the lancet can be removed and replaced. The cap 16 also includes an opening that allows passage of the lancet 13 through the cap 16 into the user's skin. Cap 16 may have a multi-contoured surface to promote, enhance or facilitate the compression of blood by pressing the device onto the skin. The assembly further comprises a depth adjustment knob 18 located at the distal end of the drive train opposite the lancet. Rotation of the depth adjustment knob reduces or increases the puncture depth of the lancet. The depth adjustment knob adjusts the drilling depth in accordance with known techniques.

The test strip cartridge 19 is loaded in the meter 10 and includes a stacked source of test strips disposed within the cavity or hollow of the cartridge housing. The test strip cartridge is adapted to dispense individual test strips into the supply channel 20. The outlet of the supply channel is connected to the outside of the measuring system 10.

The housing may include an inner wall that defines the inside of the cap 16. Alternatively, the housing wall may be a frusto-conical or funnel shape, or have any suitable shape for precisely controlling the movement of the lancet.

The cap is precisely dimensioned such that the lancet 13 slides through the cap. In this arrangement, the lancet 13 is precisely positioned in the same position at each deployment. Correspondingly, each test strip is precisely located in the same position at each time it is moved from the cartridge to the sample receiving position.

The test strip cartridge 19 includes replaceable and one-time parts of the sampling and test meter. When the source of the test strip is depleted or exhausted, the user opens the meter 10, removes the used test strip cartridge 19, and shows a new test strip containing a new test strip source, as shown in FIG. The cartridge can be inserted. Details of the test strip cartridge 19 are described in greater depth below.

The strip dispensing system operates in cooperation with the test strip cartridge 19 to dispense the test strips one by one through the supply channel 20 to a sample receiving position for performing sampling and analysis of blood samples. According to the illustrated embodiment, when the user slides the knob 21 of the meter 10 in a direction away from the cap 16, the strip dispensing system feeds the foremost test strip in the stack to the outside of the test strip cartridge. Push into me According to a preferred embodiment, the knob 21 has the additional function of simultaneously caulking the lancet assembly to prepare the lancet assembly for puncturing the user's skin when the user presses the cap 16 against the skin. To perform. Operation of the strip dispensing system and knob 21 is further described below.

To enable electrochemical analysis of the sample, the meter further comprises an electrical contact disposed in the supply channel 20 and configured to contact the electrode formed on the test strip. The electrical contacts are connected to electronics 22 located in the modular housing 11 of the sampling and test measurement system. The electronics are arranged to cause the meter to switch from a "low" power mode to a "high" power mode after contact with the electrodes in the strip makes contact.

The test strip generates an electrochemical signal delivered by electrical contacts to the housing electronics. The electronics process the signal and produce a blood glucose level or other electrochemically detectable sample of blood or interstitial fluid sampled by the test device. The electronics transmit instructions for output related to the appropriate display or analysis.

As shown in FIG. 4, the feed channel 20 has a pair of arms therein biased to move toward each other. Each arm has a triangular contact 31 at its free end. The strip has a triangular cutout 33 therein. When the strip is fed into the feed channel, the contact 31 on the arm 30 is snapped into the cutout 33 to keep the strip in the sample receiving position.

Alternatively, the supply channel may comprise a step located adjacent to the electrical contact. The electrical contacts are spring biased so that after the test strip is positioned at the sample receiving position, the electrical contacts are supported on the test strip and firmly positioned at the stepped portions.

In either way, the strip is prevented from moving backward from the sample receiving position.

The integrated sampling and test meter 10 includes a visual LCD display 34 for displaying information related to the analysis of the sample. According to an exemplary embodiment, the information in the display includes the measured blood glucose level in the blood sample and the time and date of the measurement. The display may also provide information about the number of test strips remaining in the test strip cartridge, operating temperature, effective date of the test strip cartridge, instructions for the user, and the like. According to one embodiment of the invention, the test results are stored in a memory in the measurement system, and the display 34 allows the user to view previous test results.

In addition, the measuring system has a button 35 on its outside, which can be used by the user to input data into the electronics of the measuring system. This may be accomplished by using a button for navigation through one or more menus displayed on the display 34.

To measure blood glucose levels with the integrated meter 10, the user first pushes the knob 21 away from the cap 16 to simultaneously caulk the lancet assembly, automatically open the test strip cartridge, and test strip from the cartridge. Is advanced through feed channel 20 to the sample receiving position shown in FIG. The user then presses the cap 16 against a body part, such as a finger or forearm. This releases the lancet assembly, which triggers the lancet 13 into the skin at a predetermined depth and in the correct position. The lancet assembly immediately withdraws the lancet from the skin.

The cap 16 includes a pressure ring (not shown), so that a drop of blood of the required size is formed on the skin of the user since the meter is pressed on the skin before, during or after the perforation is made. The user then moves the measurement system to bring the sample receiving area of the strip into the sample receiving position so as to contact the drop. When blood contacts the sample receiving area of the test strip, capillary forces absorb the blood into the strip for analysis. The user holds the meter firm against the skin, typically for about 3 to 10 seconds, until a sufficient amount of blood is absorbed into the test strip. According to one embodiment, the meter 10 generates an audible or visible signal to the user indicating that sufficient blood samples have been collected and the analysis has begun. Thereafter, the user removes the measurement system from the skin and the electrochemical analysis of the sample continues until the results are displayed.

The disposable strip cartridge 19 includes a plurality of parts designed to facilitate automatic individual dispensing of the test strips. The test strip cartridge includes a test tube housing, a cartridge housing containing a stack of test strips, a cartridge cap and a push up or deflection mechanism. The test strip stack includes about 50 test strips that are vertically aligned. However, the test strip cartridge of the present invention is not limited to 50 test strips in a stack, and may include any number of stacked test strips.

The push up mechanism biases the test strip stack towards the cartridge cap, so that when the foremost test strip is removed from the stack, the remaining test strips in the stack advance by one. After the foremost strip is removed from the stack, the next strip in the stack moves upwards and is ready to be dispensed for subsequent analysis. The push up mechanism includes convenience devices such as loaders and tensioners that press against the final strip in the stack. The tensioner includes a constant force clock spring that applies a constant pressure to the stack.

The push up mechanism further includes a tensioner retainer for securing the tensioner to a portion of the cassette housing. The test tube housing further includes a notch for removably locking the cartridge in the modular housing of the measurement system. When the cartridge 19 is loaded into the meter, the test tube housing is explicitly clicked in place to ensure precise engagement.

The cartridge cap includes a hermetically sealed element to protect the test strips from moisture, which can damage the test strips and damage the test results. Alternatively, the seal is contained within the test tube housing that meets the cap.

According to one embodiment, the cartridge material itself may have drying characteristics, or a desiccant may be disposed in the interior space of the test tube. Any moisture that can migrate into the test strip test tube is absorbed and neutralized by this material.

As can be seen from FIG. 3, the cap, drive train, slidable knob and strip ejection lever (see below) reside in a single subhousing, which allows the insertion of the cartridge and removal of the used cartridge. It is suitable to be rotatably attached to the rest of the. The subhousing may be released by the operation of the release knob 39.

The cartridge includes a rewritable memory module thereon, such as an EPROM or EEPROM chip. In this case, the electronics in the measurement system include means for interfacing with the memory module such that the measurement system can read from and write to the memory module.

The memory module includes a calibration code for the cartridge, and preferably includes a unique code for the cartridge and its expiration date. It may also include a compensation factor for the analysis of different fluids (venous arteries or neonatal blood or interstitial fluid), the number of strips in the cartridge, and other relevant information. The electronics in the measurement system are set to use certain data stored in the memory module, in particular calibration codes.

The electronics are also configured to write information to the memory module, such as the number of strips used, the length of time the cartridge remained open, the date of cap first opening, the date and time of each test performed and the results of each test.

The cartridge may alternatively contain such data in visible form, such as a barcode, or in other forms, such as a resistive bridge circuit.

The cartridge cap is releasably locked in place on the cartridge by a cap retainer. The cartridge cap includes a "pop-up" feature to enable the strip dispensing mechanism in the measurement system to forward individual strips to the feed channel 20. The cartridge cap is flexibly attached to the test tube housing by side supports, hinges, springs or other suitable mechanism. Propulsion of the cap retainer releases the lock on the cartridge cap, causes the cap to pop up a predetermined amount, and allows the foremost test strip in the stack to be fed to the sample receiving position.

The strip dispensing system, in cooperation with the pop-up cartridge cap described above, pushes the foremost test strip of the test strip stack into the supply channel 20 to position the test strip at the sample receiving position. As described above, the strip dispensing system includes a slidable knob 21.

Those skilled in the art will appreciate that any suitable mechanism can be used to advance the test strip into the supply channel and to ensure that the test strip is fully dispensed. Once entered into the feed channel, the test strip is positioned to receive a blood sample for analysis. After the analysis is completed, the user relocates the cartridge cap, for example to reseal the cartridge by the action of the eject lever 36.

The slidable knob 21 further comprises means for aiming the drive train of the measuring system 10. According to one embodiment, the knob further operates to switch the electronics of the meter 10 to prepare the meter for analysis of the intended blood sample. According to an alternative embodiment, the electronic device comprises a strip detector to detect the presence of a test strip in the supply channel. Thus, when the strip detector detects a strip near the puncture position, the electronics are turned on.

According to one aspect, the strip dispensing system is designed to ensure that only one test strip is loaded at a time. The strip dispensing system comprises interlock means which cooperate with the slider. The strip distribution system allows only one test strip to be advanced at a time. After the slidable knob is released and the slider returns to its initial position, the interlock means automatically rotate to a position that defeats subsequent attempts to load additional test strips into the feed channel. The release of the cartridge cap caused by the operation of the knob allows the interlocking means to be rotated after the slider is returned to its idle position. After advancing one test strip, the slider root is biased into the cartridge rather than into the feed channel of the meter 10 through the test strip cartridge.

When the user presses the closed cartridge cap, the interlock means rotates back and the strip dispensing system is reset to dispense the new strip. If the test strip is already loaded in the supply channel, the further operation of the slidable knob 21 merely cocks the lancet assembly and does not load another test strip into the channel. In this way, the strip dispensing system enables multiple caulking and puncture starts using the same test strip. This feature is particularly useful when the lancet is unintentionally released or the puncture action does not produce a sufficient amount of blood. In this case, the lancet assembly can be recoked without wasting the test strip.

The test strip cartridge 19 and strip dispensing system, in cooperation with the lancet assembly illustrated in FIG. 1, allow for effective and low pain acquisition and analysis of blood samples from the user. As described above, the operation of the slidable knob 21 simultaneously caulks the lancet assembly and advances the test strip from the cassette into the feed channel 20. The drive train for the lancet assembly includes a drive tube, a lancet holder slidably mounted in the drive tube to hold the lancet 13, a first spring for forcing the lancet holder forward, and a lancet after the lancet has perforated the skin. And a second spring and depth adjustment knob 17 for withdrawing 13). The lancet assembly includes a cap 16 having an opening to shield the lancet when not in use and to guide the lancet 13 through the opening to the user's skin.

When the slidable knob 21 is actuated, the drive tube withdraws the drive tube to equip the lancet assembly, while at the same time a test strip is supplied through the supply channel 20 to the sample receiving position shown in FIG. The user presses the cap 16 against a body part, such as a finger or an arm, to allow the lancet assembly to drive the lancet tip into the skin. The lancet assembly then withdraws the lancet tip from the skin.

The pressure ring, when present, compresses the skin to maximize the amount of blood formed from the perforations. Once the blood droplets have grown large enough, the user moves the meter to bring the sample receiving area of the strip into contact with the blood droplets that penetrate into the strip. The test strip automatically guides the blood sample to the analyzer, and the analysis of the blood sample begins automatically.

After the analysis is completed, the user can open the cap 16 and remove the lancet 13 from the lancet holder. Thereafter, the user discards the lancet 13 as necessary. Those skilled in the art will appreciate that alternative lancet assemblies may be used in accordance with the teachings of the present invention. By way of example, the present invention is not limited to the dual spring driven train of the exemplary embodiment of the present invention.

5 illustrates a test strip design suitable for use with the present invention. Test strips can be manufactured using OneTouchUltra (available from LifeScan, Inc. (Milpitas, CA, USA)) technology, membrane strip technology or other test strip designs known in the art for electrochemical or photometric analysis of fluids. Can be used. According to one embodiment, the test strip includes, as its sample receiving area, a channel inlet 141 for guiding a blood sample to the analysis of the strip. The test strip substantially comprises an electrochemical cell, the electrochemical cell comprising one or more working electrodes 142, which acts as a current to the chemical changes produced by the reaction of glucose or other analyte in the blood sample. Convert to The test strip further includes a reference electrode 143 as a standard for measuring the potential of the working electrode. Lead 144 connects the electrode to contact bar 145 configured to contact an electrical contact of an integrated test meter. Thus, the test strip generates a signal indicative of the level of blood glucose or other analyte in the blood and passes this signal to the electronics of the device for processing. Those skilled in the art will appreciate that various test strip designs and structures are possible in accordance with the teachings of the present invention.

6 shows a schematic diagram of an electronic device included in an integrated measurement system of the present invention. The electronic device receives a signal from an electrical contact, processes the signal, and sends an instruction for display appropriate to the display of the device. As shown, input signals related to the electrochemical analysis of the sample are provided from the test sample to the signal processing system. The signal is passed to the processor via analog circuitry, which performs data analysis. The processor provides a signal to a display driver connected to the output display. The processor also provides a signal to the alert generator. The display and alarm generator together configure the output of the device. The data analysis processor also communicates with a memory module, such as an EEPROM, which stores information including calibration information and previous test results.

According to an embodiment of the invention, the electronic device further comprises a detector for sensing the strip in the supply channel. The detector may be two contacts stored by the conductive layer on the strip when the strip is in the sample receiving position. The electronics can be designed to generate an audible beep or visible signal to indicate to the user that sufficient samples have been obtained and that the analysis has been completed. The electronics also read, store and / or display information about the date and time of the test, the status of the strip, the number of remaining strips in the stack, the calibration code for the strip, the effective date of the test strip cartridge, the battery power of the meter, and the like. Can be. As mentioned above, the test strip designation information can be read directly from the cartridge, for example using a barcode, a resistive bridge or a memory module, preferably a rewritable memory module.

As described above, according to one embodiment, the electronic device is turned on when the user pushes the knob of the integrated test meter or when the test strip detector detects that the test strip is loaded at the sample receiving position. At each time the electronics are turned on, the data on the cartridge is read to ensure that the correct calibration code and other data are used to control the measurement system. This ensures that accurate test results are obtained even when the cartridge is replaced.

According to another embodiment of the present invention, the electronic device is turned off when the user replaces the test strip cartridge cap and ejects the used test strip from the meter. This provides an additional safety feature that ensures that the cartridge is closed as long as possible. This minimizes the exposure of the cartridge's contents to the atmosphere. The electronics in the measuring system are arranged to record the length of time between the strip reaching the sample receiving position and the discharge from the measuring system. This is a measure of cap opening time. If the total cap opening time exceeds a predetermined value, the electronics are arranged to provide an audible or visible alarm signal. The electronics are arranged to provide such a signal or to turn off the measurement system even if a predetermined signal strip remains in the sample receiving position for longer than a predetermined time.

7 is a cross-sectional view showing one embodiment of a cartridge 19 for holding and dispensing a test strip 206 according to the present invention. The cartridge has a housing 200 for storing a plurality of test strips 206 stacked vertically along a plane. The test strip 206 is dispensed at one time through the opening 208. The cartridge 19 has a cover 202 which is deflected with respect to the surface 212 of the housing at the edge of the opening by deflection means 275 fixed to the measuring system 10. The cover is shown in the closed position in FIG. 7. The seal 204 surrounds the lid 208 and contacts the sliding surface 210 of the lid 202 so that the test strip 206 inside the housing 200 is firmly sealed from the atmosphere.

At least one section of the sliding surface 210 of the cover 202 is inclined with respect to the housing surface 212 at the edge of the opening 208 and forms a slot 211 in the cover 202. In the closed position shown in FIG. 7, the base 210b of the slot 211 is aligned in parallel with the surface 212 of the housing. The cover 202 is opened by, or directly by, a mechanical connection to another actuator or lancet device of the measuring system 10 in which it is disposed and by sliding onto the reference surface 216 on the housing 200. When the lid is opened, the inclined section 210a of the slot 211 slides over the surface of the housing 200 which raises the lid onto the seal 204 which is a cam-shaped section, thereby providing the cartridge 19 ) Is not sealed. Similarly, the sliding surface 210 of the slot 211 is slid over the inclined section of the reference surface 216 to lift the cover 202 away from the seal 204. The deflection means 275 deflects the sliding surface 210 with respect to the reference surface 216.

8 is a cross-sectional view of the cartridge of FIG. 7 with the lid 202 in the open position. The stepped portion of the sliding surface 210 at one end of the cover 202 is adapted to receive the top strip 270 from the stack of test strips 206 when the cover 202 is in the open position as shown. There is 214. The strip deflecting means 230 presses the stack of strips in the direction towards the cover 202. The face 214a of the stepped portion is aligned in parallel with one end of the top strip 270. As the lid 202 slides toward its closed position, the top strip 270 is pushed out of the housing 200 by sliding across the top of the stack of strips 206. The inclined section 210a of the slot 211 engages the surface 212 at the edge of the housing 202 such that the lid 202 is sealed by the deflection action of the deflecting means 275. Descends. The slot face 210c engages with the second surface 213 of the housing to prevent the lid 202 from slipping into its closed and sealed position.

In this way, the cartridge 19 of the present invention is unsealed of the lid 202 from the housing 200, discarding the test strip in a two-step movement of the lid 202 and covering the lid for the housing 200. A reseal of 202 is accomplished.

There is also an electronic memory chip 250 that is secured to an outer surface of the housing 200. Data can be recorded and read from the electronic chip. The chip stores data about the number and shape of test strips 206 in the housing 200.

A more detailed description of the cartridge and feeder mechanism for use herein is described in the Applicant's co-pending International Patent Application No. PCT / GB02 / 0207609.9 (Representative Reference No. : P030115WO). The contents of this PCT application refer to the starch herein.

The integrated meter and parts thereof of the present invention provide a significant improvement in the detection and monitoring of blood glucose levels in the blood. The present invention significantly reduces the discomfort and pain associated with blood glucose monitoring. The invention also improves the efficiency and accuracy of the test by providing automated delivery and analysis of samples. The present invention provides an integrated test meter with simple operation that is user friendly. The integrated test meter is compact, ergonomically complete, discontinuous and can be adjusted for different users and body parts, while at the same time providing fast and accurate results.

The present invention achieves a reduction in pain associated with multiple modes of testing. Shallow skin perforations can be used to achieve sufficient blood samples, reducing the deep perforations with pain in sensitive body parts. The present invention does not require a large sample volume for analysis. In use, the pressing device is formed by, for example, a pressing ring on the cap, thereby providing a high yield from a small perforation. Integrated sampling and testing properties further warrant the full use of the obtained sample and the limitation of "leftovers" on the skin. In current systems, the transfer from complex and inaccurate sampling points to the sample receiving area on the test strip requires surplus samples due to the poor utilization of the resulting sample droplets. The present invention reduces the inefficiency of this sample delivery and provides optimum utilization of the sample obtained by guiding the sample to the correct location on the test strip. Optimal utilization of sample droplets reduces the number of attempts needed to provide enough samples for effective analysis and thus reduces the number of punctures required. Shallow perforation reduces irritation of the nerve endings of the skin and reduces pain in sensitive body areas. In addition to the finger, the test function and multiple depths of perforation on a number of different body parts reduce the concentration and repetition of microtraumas in smaller areas, which is caused by tinting avoids the problem of itching, dry and hard skin areas.

The integrated measuring system of the present invention fully exploits the technological advances in strip design that allow the use of smaller samples. Currently available strips require only 1-3 μl of sample. A sample of blood or other body fluid compressed from the user is sufficient to accurately determine and monitor the presence or absence of an analyte such as glucose.

In addition, the present invention provides an easy and simple operation. The use of a measuring system significantly reduces the time and difficulty involved in the sampling and testing of blood. The integrated measuring system provides substantially three devices, drilling means, supplying test strips, measuring system in a single small housing. The system is also designed for one-handed operation, eliminating the need for a work space or plane. This meter is not subject to human error and is not inefficient. In addition, the integration of disposable test strip cartridges enables simple, accurate and easy loading of the test strip. In current glucose monitoring systems, the user must use both hands to mount the strip in the glucose meter. However, in the measuring system of the present invention, the test strip dispensing system automatically loads the test strip in a position for receiving a blood sample. In addition, the present invention reduces waste by efficiently utilizing available resources. The present invention is also protected against compromised test results due to incorrectly calibrated glucose meters or contaminants.

In conclusion, the integrated meter of the present invention significantly reduces the obstacles associated with frequent blood glucose monitoring. The present invention facilitates frequent monitoring for diabetic individuals by providing a simple, effective, fast and accurate integrated measurement system.

As specific changes may be made in the above-described configuration without departing from the scope of the present invention, all of the above-described or shown in the accompanying drawings are only illustrative and should not be construed in a limiting sense.

In addition, the following claims encompass all inclusive and specific features of the invention described herein and all descriptions of the scope of the invention included here in language.

Claims (44)

In an integrated sample-test meter comprising a single modular housing, Drilling means; A drive train for driving said puncturing means between an extended position and a retracted position; A test strip cartridge containing a plurality of test strips each having a sample receiving area; A sensor for analyzing a fluid sample received on the test strip; A test strip dispensing system for individually moving the test strip from the cartridge to a sample receiving position where the test strip is connected to the sensor; When in use, the measuring system, when placed and operated in a first position on the user's skin, moves the perforation means to its extended position and then contracts to form a perforation in the user's skin, and a test strip is provided from the cartridge to the sample. Integrated sample test meter arranged to be moved to a receiving position. 10. The integrated sample test meter of claim 1, comprising electrical or electronic circuitry for controlling the operating position. 3. The circuit of claim 2, wherein the circuit comprises a visual display unit, Integrated sample test meter, wherein the user can read certain specific test results from the unit. 4. The integrated sample test meter of claim 2 or 3, wherein the circuit comprises means for inputting data into the meter. 5. The integrated sample test meter of claim 1, comprising a pressurization device arranged to promote fluid droplet formation around the perforation. 6. The integrated sample test meter of claim 5, wherein the pressurization device comprises a pump adapted to apply a negative pressure to a volume in the meter that has an opening relative to a location on the user's skin. 7. The integrated sample test meter of claim 6, wherein the opening through which the puncturing means extends is made of an anti-slip material. The method of claim 5, wherein the pressing device comprises a pressing ring, And the pressurized ring is positioned on the user's skin in use and arranged to apply pressure to the edge of the ring to increase the amount of fluid available at the center of the ring. 10. The integrated sample test meter of claim 8, wherein the pressure ring is made of an anti-slip material. 10. The integrated sample test meter of claim 8 or 9, wherein the pressure ring is shaped to conform to the shape of the area of the skin to which it is applied. 11. The integrated sample test meter of claim 8, wherein the pressure ring has a multi-contoured surface for increasing pressure gradient from outside the ring to the inside. 12. The integrated sample test meter of claim 11, wherein the pressure ring is part of a cap that covers the perforation means at its retracted position. 12. The integrated sample test meter of claim 1, comprising a cap, wherein the cap covers the perforation means at its retracted position. 14. The integrated sample test meter of claim 12 or 13, wherein the cap is detachably mounted to the housing. 15. The integrated sample test meter of claim 1, wherein the drive train is spring driven. 16. The integrated sample test meter according to any one of claims 1 to 15, wherein the drive train comprises an adjusting screw that allows a user to set the extension position of the puncturing means. 17. The integrated sample test meter of claim 16, wherein the operation of the adjusting screw is arranged such that many of the extension positions of the puncturing means are changed while the movement distance of the puncturing means remains constant. 14. A drive according to any one of claims 12 to 13 or any of the dependent claims, wherein the cap comprises means for guiding the drive train such that the perforation means punctures the skin at substantially the same place in each actuation of the drive train. Provides integrated sample test meter. 19. The cavity of any one of the preceding claims wherein the test strip cartridge defines a cavity configured to receive a stack of test strips, a partially detachable cartridge cap and means for moving the stack strip towards the cartridge cap. An integrated sample test meter comprising a cartridge housing. 20. The integrated sample test meter of claim 19, wherein the cartridge has data related to a calibration code for a strip in the cartridge. 21. The integrated sample test meter of claim 20, wherein the data on the cartridge is in a mechanically readable format. 22. The integrated sample test meter of claim 21, wherein the data is in an electronic memory module. 24. The method of any one of claims 20 to 23, wherein the data includes a unique number identifying a particular cartridge, the number of strips originally present in the cartridge, the expiration date for the cartridge, and / or different calibration factors for different fluid sources. Integrated sample test measurement system comprising a. 23. The integrated sample of claim 22, wherein the memory module on the cartridge is rewritable and the measurement system is arranged to write back to a memory module information read operation of the measurement system. Test meter. 25. The integrated sample test meter of claim 1, wherein the meter comprises a feed channel receiving the strip from the cartridge and guiding it to a sample receiving position. 26. The integrated sample test meter according to any one of claims 1 to 25, comprising ejection means for ejecting the used strip from the meter after the test is completed. 27. The apparatus of any one of claims 1 to 26, comprising interlock means operable to prevent the test strip dispensing system from moving the additional test strip to the sample receiving position while the first test strip is held in place. Integrated sample test meter. 28. The integrated sample test meter of claim 1, comprising means for ascertaining the presence of a strip at the sample receiving location. 29. The integrated sample test meter of claim 28, wherein said checking means is also used to fully operate said circuit in said meter. 30. The integrated sample test meter according to any one of claims 1 to 29, which is manually operated by using a single movement of the multifunctional assembly supported by the housing. 31. The integrated sample test meter of claim 1, wherein the strip is adapted to perform an electrochemical analysis and the circuitry in the meter is arranged to contact an electrode in the strip. 32. The integrated sample test meter of any one of the preceding claims, which is applied to perform a blood glucose test. In the method of integrally sampling and testing the blood sugar level or other analyte level of the body fluid, Mounting a test strip cartridge into the integrated test meter of any one of claims 1 to 32; Caulking the drilling device and operating the assembly on the test meter to move the test strip into the sample receiving position; Pressing the integrated test meter on the skin of the user; Operating the puncturing means to form a drop of blood or other fluid on the skin surface; Moving the measurement system to allow the test strip to absorb the amount of blood or other fluid needed for automated analysis of the integrated test measurement system. A cartridge for holding and dispensing a test strip, A housing including a test strip and having an opening; A lid adapted to join a test strip from the housing and slidably attached to the housing; A seal for sealing the opening; In the first position the cover closes the opening and engages with the seal, in the second position the cover is released from the seal and in combination with the test strip in the housing, thus from the second position the first position The movement of the furnace cartridge releases the test strip from the housing. 35. The cartridge of claim 34, wherein the lid has a sliding surface parallel to the mating surface at the edge of the opening. 36. The cartridge of claim 35, wherein the sliding surface has a step for joining a test strip. 36. The cartridge of claim 35, wherein at least one section of the sliding surface is inclined with respect to the engagement surface of the opening edge such that sliding of the lid from the first position to the second position releases the lid from the seal. 38. The cartridge of any one of claims 35 to 37, further comprising a reference surface attached to the housing wherein the lid is slipped and at least one portion is inclined with respect to the mating surface of the opening edge. 39. The cartridge of any one of claims 34 to 38, further comprising strip deflection means in the housing for deflecting a stack of test strips contained in the housing relative to the sliding surface. 40. The cartridge according to any one of claims 34 to 39, further comprising cover deflection means for deflecting the cover relative to the seal in the first position. 41. The cartridge of any one of claims 34-40, further comprising a dry material. 42. The cartridge according to any one of claims 34 to 41, further comprising recognition means for holding data with respect to a test strip in said housing. 43. The cartridge according to claim 42, wherein said recognition means is a readable and writable electronic memory chip. A method for dispensing a test strip from a cartridge housing, the method comprising: Sliding the lid from a first position in which the lid closes the opening in the housing and engages the seal around the opening, from the seal to a second position where the lid is released from the seal and engaged with the test strip in the housing; And by sliding the lid from the second position to the first position, the joined test strip is pressed out of the housing by the lid.