Field of the Invention
The present invention relates to an integrated sample testing meter for use in
sampling and analyzing analytes, particularly glucose, in fluids such as blood or interstitial
fluid.
Background of the Invention
'\ Glucose monitoring is a fact of everyday life for diabetic individuals. The accuracy
of such monitoring can literally mean the difference between life and death. Generally, a
diabetic patient measures blood glucose levels several times a day to monitor and control
blood sugar levels. Failure to test blood glucose levels accurately and on a regular basis
can result in serious diabetes-related complications, including cardiovascular disease,
kidney disease, nerve damage and blindness. A number of glucose meters are currently
available which permit an individual to test the glucose level in a small sample of blood.
Many of the glucose meter designs currently available make use of a disposable test
strip which, in combination with the meter, electrochemically or photometrically measures
the amount of glucose in the blood sample. To use these meters, the user first punctures a
finger or other body part using a lancet to produce a small sample of blood or interstitial
fluid. The sample is then transferred to a disposable test strip. The inconvenience of
taking several measurements a day, as well as the pain inflicted by currently available
lancets, often discourage disciplined and frequent testing.
While the fingertip is generally used for sampling blood, due to the rich capillary
bed of the skin of the fingertip, the fingertip is also particularly sensitive to pain, due to a
rich supply of pain receptors in the finger tip as well. When a puncture is too deep, too
close to a recent puncture or not deep enough and requires an additional puncture, the pain
increases significantly. Pain may also be increased if the lancet penetrates slowly or is
withdrawn slowly. Furthermore, the user may be forced to make a larger puncture than is
necessary to form a sufficient amount of blood, due tp losses during the transfer between
the puncture site and the test strip.
The process of measuring blood glucose levels requires several steps and several
different accessories, including a lancing device, a lancet, a supply of test strips and a
glucose meter. Each accessory has a different function. The user must have a flat surface
available to unpack and lay down the accessories within easy reach. This, by itself, poses a

challenge for those who need to take measurement while participating in outdoor
activities. Flat surfaces are often not available and this can discourage a person
from taking a measurement. This can be disadvantageous because blood
glucose levels may change significantly during an outdoor activity.
Even if a user can find a flat surface, the user has to carry out the following
steps. The user: charges the lancing device with a fresh lancet; opens a vial
strips; removes a strip; inserts the strip into the meter, re-closes the vial; checks
for the correct calibration code on the meter; picks up the lancing devices; lances
the skin of the finger or other body part; lays down the lancing device; squeezes
or massages the finger to yield an adequate blood sample; transfers the sample
to the test for analysis; waits for the meter to analyze the sample; removes the
strip from the test meter; discards the strip; and finally re-packs all of the
accessories. As set forth above, the standard procedure for taking a glucose
measurement requires the use of multiple, separate components and the
execution of a number of steps requiring manual user intervention.
Generally, the user is required to transfer a small volume of sample to a sample-
receiving area on the test strip. Generally, test strips are quite small and the
sample-receiving area is therefore even smaller. This transfer step is a difficult
task for many user. Moreover, there has recently been a trend towards the use of
test strips requiring ever smaller amounts of sample. (This allows the use of
smaller punctures and therefore less painful lancing.) However, the use of

smaller samples increases the difficulty in transferring the sample to the sample-
receiving area on the test strip. This is especially difficult for user with poor
eyesight, a common complication for diabetics.
The pain, inconvenience, cost, slowness, complexity and discreteness of taking a
blood glucose measurement are barriers to the frequent monitoring of glucose
levels. Patients often do not comply with doctor recommendations to frequently
test glucose levels due to the numerous obstacles involved.
The present invention seeks to overcome some of the drawbacks of the prior art
as mentioned below.
The user need not find a flat surface as required in prior art. Moreover, the user
is no longer required to accurately transfer a small volume of sample to a sample
receiving area on the test strip. This activity of the prior art, which can be
particularly difficult for the visually challenged, is dispensed with.
The present invention provides a pressure ring and a pressure device which
together reduce the pain associated with puncturing the skin for collecting blood
sample.

a lancet drive train for driving the lancet between an extended position and a
retracted position;
a test strip cartridge containing a plurality of test strips, each strip having a sample-
receiving area;
a sensor for analyzing a fluid sample received on a test strip; and
a test strip dispensing system for moving test strips individually from the cartridge
to a sample-re.ceiving position in which the sample-receiving area of the test strip is in
proximity to the location of the end of the lancet in its extended position and in which the
test strip is connected to the sensor,
the meter being arranged such that, in use, when it is located on the skin of a user
and is activated, the lancet is moved to its extended position and retracted to form a
puncture in the user's skin, the pressure device causes a drop of fluid to form around the
puncture, a test strip is moved from the cartridge to the sample-receiving position, the test
strip receives a sample from the fluid drop and the sensor analyzes the sample.
The meter of the present invention will include electrical or electronic circuitry for
controlling its operation. Such circuitry may be hard-wired or may comprise a
microcomputer or similar device. Such circuitry will in particular include all the
components of the sensor and will be arranged to carry out the analysis of the sample.
Preferably, the circuitry also includes a visual display unit from which the user can
read out the results of any particular test. The display may also be adapted to provide a
display of the data, as explained in more detail below.
Preferably, the circuitry includes means, such as a touch sensitive display, a
microphone and voice activated software or control buttons, for entering data into the
meter.
Preferably, the meter is arranged such that, in use, when strip is in the sample-
receiving position, its sample receiving area is spaced from the puncture site by a distance
of from about 0.4 mm to about 1.3 mm and preferably by a distance of about 0.7 mm to
about 0.9 mm.
The pressure device may comprise a pump adapted to apply a negative pressure to a
volume in the meter having an aperture for location on the skin of the user.
Preferably, however, the pressure device comprises a pressure ring arranged to be
located, in use, on the user's skin and to apply pressure at the edges of the ring to increase
the amount of fluid available at the centre of the ring.

The pressure ring may be shaped to conform to the shape of the area of the skin to
which it is to be applied. For instance, if the meter is intended for use on the forearm, the
pressure ring will be generally planar. However, if the meter is intended for use on a
finger, the pressure ring will be curved.
Preferably, the pressure ring has a multi-contoured surface to increase the pressure
gradient from the outside to the inside of the ring.
Advantageously, the pressure ring is part of a lancet cap which covers the lancet in
its retracted position. Preferably, the lancet cap includes a means, such as a side wall,
which co-operates with the lancet drive train to ensure that the lancet travels along
approximately the same path on each activation of the drive train.
The lancet cap may be an integral part of the housing. Preferably, however, the
lancet cap is detachably mounted on the housing. This may be achieved by use of screw-
thread or bayonet type fixings or by use of a snap fit connection.
If desired, the meter can include at least two interchangeable lancet caps, for
instance a lancet cap for forearm use and a lancet cap for finger use.
The lancet may be any of the types of lancet at present in use in the art. The term
"lancet" includes finger-sticking devices of the type known in the art. Preferably, the
lancet is removably attached to the lancet drive train so that the lancet can be disposed of
after one or several uses.
Preferably, the lancet drive train is spring driven. Alternatively, the lancet drive
train is driven electromagnetically. The drive train is arranged such that, on actuation, the
lancet moves to the extended position and is retracted.
Preferably, the lancet drive train includes an adjustment screw which allows the
user to set the extended position of the lancet. This enables the user to calibrate the
operation of the meter such that his or her skin is punctured sufficiently to allow a large
enough drop of fluid to form without causing too much pain.
Advantageously, the operation of the adjustment screw is arranged such that the
distance of travel of the lancet remains constant, however much the extended position of
the lancet is changed. This ensures that the amount of pain experienced by the user does
not increase disproportionately to the depth of puncture.
Where the meter includes a lancet cap, it is preferable, as noted above, that the
lancet cap provides a means for guiding the lancet drive train so that the lancet punctures
the skin at approximately the same place on each actuation of the drive train.

Advantageously, in such case, the lancet drive train is arranged such that the end of

the lancet, in its extended position, extends to approximately the plane formed by the

pressure ring or aperture in the housing which, in use, is placed on the user's skin.
Preferably, the test strip cartridge comprises a cartridge housing defining a cavity

configured to receive a stack of test strips, a partially detachable cartridge cap and a means
for moving the stack of test strips towards the cartridge cap.
The test strips used for some measurements are air-or moisture-sensitive. It is

therefore preferred that the cartridge includes a seal for sealing the cartridge cap to the cartridge housing when the cartridge cap is fully engaged with the cartridge housing. The
seal may be on the cartridge cap or on the cartridge housing. Further, the cartridge may be
manufactured from a material having dessicant properties, or a dessicant may be contained
within the cartridge.
In use, upon activation of the meter, the cartridge cap is partially detached 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 measurement has been taken, the cartridge cap is preferably manually replaced on the cartridge housing to close
the cartridge and seal its contents from atmospheric effects.
Preferably, the cartridge has on it data relating to the calibration code for the strips
in the cartridge. The data may be present as visually readable indicia. In this case, the
meter must include means, as mentioned above, to allow the user to enter the calibration
code into the meter.
Preferably, however, the data on the cartridge are present in machine-readable
format, for instance as a bar code or a resistance bridge circuit or stored in an electronic
memory module.
If the data are present as a bar code, the meter will include a bar code reader. This
may be a scanning reader or a stationary reader. A scanning reader will be more
complicated but can be used when the cartridge is fitted in the meter. A stationary reader
is less complicated but can only be used as the cartridge is inserted into or taken out of the
meter.
If the data are present in an electronic memory module, this may comprise a read-
only memory (ROM), or a rewritable memory, such as an EEPROM.
Preferably, the data also include a unique number identifying the specific cartridge,
the number of strips originally present in the cartridge, the expiry date for the cartridge,

different calibration factors for different sources of fluid (neonatal, arterial or venous
blood, for instance) and any other relevant information such as control solution range
information, preferably in machine-readable format, to assist in operation of the meter.
Where the memory module on the cartridge is rewritable, the meter may be

arranged to write back into the memory module information such as the number of strips
used, the date the cartridge was first used, the length of time the cartridge has remained
open and the date, time and result of each test that was carried out with a strip from the
cartridge.
Preferably, the test strip dispensing system includes a slider adapted to engage with
only one of the test strips in the cartridge and move it to the sample-receiving position.
Advantageously, the meter includes a feeding channel which receives the strip from
the cartridge and guides it to the sample-receiving position.
Preferably, the feeding channel includes a step arranged such, when the strip has
been moved past the step, the strip drops, or is forced, into the step, thereby preventing the
strip from moving back towards the cartridge.
Preferably, the strip is forced into the step by springs located on the meter.
Advantageously, the springs are also electrically conductive and are arranged to make

electrical contact with electrodes or a conductive bar on the strip (see below).
Preferably, the feeding channel is arranged such that the major plane of the strip,
when in the sample-receiving position, is at an angle of from about 30° to about 60°,
preferably about 45°, to the direction of movement of the lancet towards its extended
position.
Advantageously, the meter includes an ejection means for ejecting a used test strip
from the meter once a test has been completed. Preferably, where the cartridge includes a
cartridge cap, the ejection means is operated as the cartridge cap is closed.
Preferably, the meter includes a deviator which prevents the test strip dispensing
system moving a further test strip into the sample-receiving position while a first test strip
is still in position. This is an advantageous feature as it allows the user to carry out a
number of lancing operations with the same strip in position, since, in some cases, it takes
a number of lancing operations, if necessary with adjustment of the lancet drive train, to
produce a sufficiently large drop of fluid.
Preferably, the deviator operates in conjunction with the cartridge cap. While the
cartridge cap is partially detached from the cartridge housing, the deviator blocks the

normal path for the test strip dispensing system, such as the slider, and causes it to enter
the cartridge cap.
Preferably, the meter includes a means for verifying that a strip is in the sample-

receiving position. This may comprise a reflectance meter. Generally, test strips are more
or less reflective than the surfaces of the feeding channel. Therefore, a change in
reflectance will indicate that a test strip is in position.
Preferably, however, the verifying means comprises an electrical system. At its
simplest, each strip may have on it a conductive bar arranged to short out two electrodes on
the meter. This arrangement is useful for strips arranged to carry out photometric
measurements.
Strips which are arranged to carry out electrochemical measurements already
include electrode systems. Thus, the verifying means may include electrical contacts on
the meter which contact the electrodes on the strip. Advantageously, as noted above, the
electrical contacts on the meter are spring loaded and are positioned to force the strip into
the step in the feeding channel.
Advantageously, the verifying means is also used to activate fully the circuitry in
the meter. The meter may normally be in a low power mode, where the only active
circuitry is that used to control the verifying means. Once the verifying means has
indicated that a strip is present, the meter can then automatically switch to high power
mode where all its relevant circuits are functioning.
Preferably, the verifying means is also arranged to start a timer in the circuitry of
the meter. The timer is stopped by the ejection of a used strip from the meter, preferably
by closure of the cartridge cap. This allows the circuitry to determine the length of time
the cartridge has been open to the atmosphere. Advantageously the circuitry is arranged to
sum the total time that the cartridge has been open and to produce a warning signal, such as
an audible tone or a visible signal, if the total exceeds a pre-set maximum.
Preferably, the circuitry in the meter also counts the number of strips dispensed
from each cartridge. Advantageously, the circuitry is designed to provide a warning signal,
such as an audible tone or a visible signal, when the number of strips remaining the
cartridge is low.
As noted above, the cartridge preferably includes a rewritable memory module and
the circuitry in the meter is arranged to write back to the cartridge memory module useful
information, such as the number of strips remaining in the cartridge and the length of time

the cartridge has been open to the atmosphere. The rewriting function is particularly useful where a user is likely to be away from his normal environment for a length of time which would require the use of more strips than are present in a cartridge. In such cases, a user is likely to remove the old cartridge and insert a new, full cartridge. Once the new cartridge has been used up, the user may insert the old cartridge, even if it is out of date. As long as

the meter can read the data on the old cartridge, it will be able to decide whether use of the
old cartridge should be allowed.

Moreover, the provision of a rewritable memory module enables other possible

uses. For instance, data on time and date of use and result of measurement may be written

into the cartridge's memory module. The used cartridge could then be returned to the
user's health care provider who could then study the data to determine whether the user is complying with his treatment and monitoring regime. Alternatively, the used cartridges could be returned to the manufacturer to enable a general study of use to be carried out.
Preferably, the meter is activated manually by use of a single movement, for instance of a multi-functional handle assembly carried by the housing. The handle
assembly may include a lever pivoted to the housing.
Preferably, the actuation of the handle assembly cocks the lancet drive train and
moves a single test strip into the sample-receiving position. The movement of the handle
assembly may also activate all the meter's circuitry.
The lancet drive train may be fired either by further movement of the lever or,
preferably, by actuation of a trigger.
It can thus be seen that the use of the integrated sample testing meter of the present
invention can be very simple. If desired, the user can replace an existing lancet with a new
one. The meter can then be cocked by use of the handle assembly. This also moves a strip
into the sample-receiving position. Movement of the lever or receipt of a strip in the
sample receiving position also activates all the meter's circuitry. Then, the user only has to
place the appropriate part of the meter, such as an aperture or the lancet cap, on his skin
and activate the trigger.
If the first activation of the trigger does not cause the production of a sufficiently
large drop of fluid, the meter can be cocked, positioned and fired again, if necessary a
number of times, without the need to insert a new strip.

: The presence of the pressure device ensures that, once a reasonable puncture is
,' made, sufficient fluid will accumulate around the puncture so that it will contact the
; sample-receiving area of the strip and a sample will be taken onto or into the strip,
j Thus, the use of the meter of the present invention avoids most of the steps
j presently required and in particular avoids those steps where manual dexterity and good
j eyesight are advantageous.
| Preferably, the meter is adapted to produce and analyze a sample of blood or
interstitial fluid, in particular to analyze a blood sample for glucose levels. Strips adapted
| to carry out such measurements are well known in the art. These may be electrochemical
or photometric strips.
Advantageously, the strips are adapted to carry out electrochemical analyses and
the circuitry in the meter is arranged to contact the electrodes in such strips.
Therefore, in a preferred embodiment the present invention provides an integrated
blood glucose testing meter. The integrated meter of this aspect of the present invention
allows for a simple, one-step glucose monitoring process, and significantly reduces the
obstacles involved in frequent glucose monitoring. The integrated meter provides for the
automated and precise dispensing and positioning of a test strip in repeatable close
proximity to a lancet puncture site, automated transfer of a blood sample to the test strip
and automated analysis of the blood sample after the test strip collects the sample from the
puncture site.
According to another aspect of the present invention, there is provided a disposable
test strip cartridge adapted to be loaded into the meter of the present invention. The
cartridge includes a cartridge housing defining a cavity configured to receive a stack of test
strips, a partially detachable cartridge cap and a stack of test strips disposed in the cavity.
According to another aspect, the present invention provides a multi-function handle
assembly for the meter of the present invention. Preferably, the handle assembly
comprises a lever. When a user depresses the handle assembly, the lever simultaneously
cocks a lancing device and dispenses one test strip from the test strip cartridge into the
sample-receiving position. The test strip is precisely positioned at a predetermined
distance from the lancet.
According to yet another aspect, the present invention provides a strip dispensing
system for forwarding test strips from a test strip cartridge to the sample-receiving position
in the meter of the present invention on a one-by-one basis. The strip dispensing system

I -
I includes a slider for pushing a test strip from the cartridge to a feeding channel and a
deviator for preventing a plurality of test strips from being positioned in the feeding
channel at one time. The deviator diverts the slider inside the test cartridge cap when a test
strip is positioned in the feeding channel.
According to still another aspect of the present invention, there is provided an
integrated method of sampling and testing a blood glucose level or other analyte in a
bodily fluid. The integrated method comprises loading a test strip cartridge into an
integrated testing meter, depressing a handle assembly on the testing meter to cock a
lancing device and push a test strip into a sample-receiving position, pressing the
integrated testing meter on the skin of a user and pressing a trigger of the testing meter to
drive a lancet into the skin in order to form a drop of blood or other fluid on the skin
surface. The test strip absorbs a required amount of blood or other fluid for an automated
analysis of the sample by the integrated testing meter.
Brief Description of the Drawings
These and other features and advantages of the present invention will be more fully
understood by reference to the following detailed description in conjunction with the
attached drawings in which like reference numerals refer to like elements through the
different views.
Figure 1 is a perspective view of an integrated blood and testing meter according to
the present invention.
Figure 2 is a plan view of the exterior of the integrated meter of Figure 1.
Figure 3 is a partially cut-away perspective of a disposable test strip cartridge that
mounts in the meter of Figure 1.
Figure 4 is an exploded view of the components of the disposable test strip
cartridge of Figure 3.
Figures 5a, 5b and 5c illustrate a "pop-up" feature of the cap of the disposable test
strip cartridge.
Figure 6 is a partial cut-away view of one embodiment of the integrated meter in an
idle position.
Figure 7 illustrates the integrated meter of Figure 6 when the multi-function handle
is depressed.

Figure 8 illustrates the integrated meter of Figure 6 when the multi-function handle
is released.
Figure 9 illustrates the integrated meter of Figure 6 when the multi-function handle
is pressed when a test strip is loaded.
Figure 10 is a side view of a lancet cap suitable for use with the meter of the
present invention.
Figure 11 is an end view of the lancet cap of Figure 10.
Figure 12 is a side elevational view in cross section along line 4-4 of Figure 11,
illustrating the contact ring of the cap of Figure 10.
Figure 13 is a graphic representation of the pressure profile created by the cap of
Figure 10.
Figure 14 is a cross-sectional view of an alternate embodiment of the contact ring
of the lancet cap for use with the meter of the present invention.
Figure 15 is a side elevational view of an alternative embodiment of a lancet cap
for use with the meter of the present invention, illustrating a sleeve positioned about the
cap.
Figure 16 is an end view of the lancet cap of Figure 15.
Figure 17 is a side elevational view of the lancet cap of Figure 15, illustrating the
cap displaced from the skin.
Figure 18 is a side elevational view of the lancet cap of Figure 15, illustrating the
cap in contact with the skin.
Figure 19 is a front elevational view of the cap of Figure 15.
Figure 20 is a front elevational view of another embodiment of a lancet cap for use
with the meter of the present invention.
Figure 21 is an end view of thecap of Figure 20.
Figure 22 is a front elevational view of another embodiment of a lancet cap for use
with the meter of the present invention for lancing the ventral side of a fingertip.
Figure 23 is an end view of the lancet cap of Figure 22.
Figure 24 is a side view of an alternate embodiment of a lancet cap for use with the
meter of the, present invention formed of a flexible material and disposed in a rest position.
Figure 25 is a side view of the lancet cap of Figure 24 when the contact ring of the
lancet cap contacts a lancing site.

f
! Figure 26 is a side view of an alternate embodiment of a lancet cap for use with the
l
; meter of the present invention formed of a deformable, flexible material and disposed in a
] rest position.
| Figure 27 is a side view of the lancet cap of Figure 26 when the contact ring of the
lancet cap contacts the lancing site.
Figure 28 illustrates the feeding channel of the integrated meter according to the
present invention.
Figure 29 is a schematic view of a test strip design suitable for use in the present
invention.
Figure 30 is a schematic representation of the electronics which can be incorporated
in an integrated meter in accordance with the present invention.
Figure 31 illustrates an alternative mechanism for providing a "pop-up" feature of
the cap of the disposable test strip cartridge, with the cap closed.
Figure 32 illustrates the mechanism of Figure 31 with the cap open.
Figure 33 illustrates the mechanism of Figure 31 from an opposite side.
Figure 34 is an opposite side view of the mechanism of Figure 31 with the cap
open.
Detailed Description of the Invention
The present invention provides an integrated meter for sampling and analyzing a
sample of bodily fluid, such as blood, including a disposable test strip cartridge having a
stack of test strips disposed therein. The present invention facilitates the monitoring of, for
instance, blood glucose levels by integrating into a single meter the steps involved in
sampling and analyzing blood into a simple process employing a single meter.
The present invention will be described below relative to an illustrative
embodiment. Those skilled in the art will appreciate that the present invention may be
implemented in a number of different applications and embodiments and is not specifically
limited in its application to the particular embodiment depicted herein.
The present invention will be discussed below in connection with sampling blood,
although those of ordinary skill will recognize that other types of fluid can also be used.
Figures 1 and 2 illustrate an integrated blood glucose sampling and testing meter 10
according to an illustrative embodiment of the present invention. This meter is designed to
carry out electrochemical analysis of a blood sample. However, if desired, the same

mechanical parts could be used in connection with photometric analyses. The sampling
and testing meter comprises a modular housing 11 (shown in Figure 2) encompassing an
integrated system for expressing and subsequently analyzing a sample. The meter 10
includes a lancet assembly for puncturing the skin of a user to express a drop of blood on
the surface of the skin. The lancet assembly includes a lancet 13 and a lancet drive train 14
for driving the lancet into and out of the skin. When cocked, a triggering button 15
actuates the drive train.
A lancet cap 16 is removably attached to the housing 11 at the proximal end of the
device 10 and includes an aperture to allow passage of the lancet 13 through the cap 16 and
into the skin of the user. The cap 16 can have a multi-contoured surface in order to
promote, enhance or facilitate the expression of blood by pressing the device onto the skin.
The lancet assembly further includes a depth adjustment knob 17 situated at the distal end
of the drive train opposite the lancet. Rotation of the depth adjustment knob decreases or
increases the puncture depth of the lancet. The depth adjustment knob regulates or adjusts
the puncture depth in accordance with known techniques.
A test strip cartridge 18 is loaded into the meter 10 and includes a stacked supply of
test strips disposed within a cavity or hollow interior of the cartridge housing. The test
strip cartridge is adapted to dispense individual test strips to a feeding channel 19. The
outlet of the feeding channel leads into the interior of the lancing cap 16, in precise and
close proximity to the aperture through which the lancet 13 passes when puncturing the
skin. In this manner, when the lancet punctures the skin and a drop of blood forms on the
skin surface, the test strip is located in close proximity to the puncture wound to ensure
that blood contacts the strip. Moreover, the precise positioning of the test strip adjacent the
lancet ensures that only small volumes of blood are required, as the strip is able to touch
and automatically wick up even a small drop of blood.
According to one practice, as illustrated in Figures 7, 8 and 9, the housing includes
an internal wall 19A that defines the inner side of the lancet cap 16. According to an
alternate embodiment, the housing wall 19A can have a frusto-conical or funnel shape, or
any other suitable shape, for precisely positioning the lancet relative to the test strip.
The lancet cap is precisely dimensioned such that the lancet body 13A that carries
the lancet 13 slidably passes through the cap. In this arrangement, the lancet 13 is
precisely positioned at about the same location each time it is deployed. Correspondingly,

each test strip is precisely positioned at about the same location each time one is moved
from the cartridge to the sample-receiving position.
The terms "precise" and "precisely" are used herein to include positioning the
puncture point of the lancet 13 and the sample-receiving area of the test strip relatively
close to each other in a repeatable manner.
The integrated meter of the present invention is able fully to exploit the
technological improvements in strip design which allow the use of much smaller samples.
Presently available strips require only 1 to 3 ul of sample. Many users have eyesight
problems and cannot see well enough to be able to transfer such small volumes of sample
accurately to the sample-receiving area of a strip. Such eyesight problems are common
complications of diabetes. The automatic collection and transfer of samples to the strip
enabled by the present meter is a major advantage of the present meter.
It is thus possible to arrange the operation of the lancet and the pressure device to
produce a puncture which allows a small, but sufficient, volume of blood to be expressed
as a drop of the user's skin. Such a small drop will be able to contact the sample-receiving
area of the test strip due to the precise positioning of the lancet and the test strip.
The small volume of blood or other bodily fluid expressed from the user is
sufficient to accurately determine or monitor the presence or absence of an analyte, such as
glucose.
The meter is arranged such that, in use, with the strip in the sample-receiving
position, its sample-receiving area is separated from the puncture by between about 0.4
mm and about 1.3 mm, and preferably between about 0.7 mm and about 0.9 mm.
Once the sample drop touches the sample-receiving area of the test strip, the test
strip automatically directs the blood sample to the testing portion of the strip.
The test strip cartridge comprises a replaceable and disposable portion of the
sampling and testing meter. When the supply of test strips is depleted or expired, the user
may remove the used test strip cartridge 18 and insert a new test strip cartridge containing
a fresh supply of test strips. The details of the test strip cartridge 18 are described in depth
below.
A strip dispensing system 20 operates in co-operation with the test strip cartridge
18 to dispense test strips one-by-one through the feeding channel 19 and into the sample-
receiving position to effect the sampling and analysis of a blood sample. According to the
illustrated embodiment, when a user depresses or squeezes the handle 21 of the device 10,

the strip dispensing system 20 pushes the foremost test strip in the stack out of the test strip
cartridge and into the feeding channel. According to a preferred embodiment, handle 21
performs an additional function of simultaneously cocking the lancet assembly to prepare
the lancet assembly for lancing the skin of a user when the user depresses or squeezes the
handle. The workings of the strip dispensing system and multi-function handle 21 are
described in further detail below.
To enable electrochemical analysis of the sample, the meter further includes
electrical contacts 22 situated adjacent the feeding channel 19 and configured to contact
electrodes formed on the test strip. The electrical contacts connect to electronics (not
shown) located within the modular housing 11 of the sampling and testing meter. The
electronics are arranged such that, once the contacts 22 contact the electrodes in the strip,
the meter switches from "low" power made to "high" power mode.
The test strip generates electrochemical signals that are passed by the electrical
contacts to the housing electronics. The electronics process the signal and calculate the
glucose level or other electrochemically detectable analyte of the blood or other interstitial
fluid that is sampled by the testing device. The electronics transmit instructions for an
appropriate display or output regarding the analysis.
The feeding channel 19 has in it a step 60 located adjacent the electrical contacts
22. The electrical contacts 22 are spring biased so that, once a test strip is in the sample-
receiving position, the electrical contacts 22 bear on the test strip and locate it securely in
the step. In this manner, the strip is prevented from moving backward away from the
sample-receiving position.
As illustrated in Figure 2, the integrated sampling and testing meter 10 includes a
visual LCD display 23 for displaying information related to the analysis of the sample.
According to the illustrative embodiment, the information in the display includes a
measured blood glucose level in a blood sample, as well as the time and date of the
measurement. The display may also provide information regarding the number of test
strips remaining in the test strip cartridge, the operating temperature, the expiration date of
the test strip cartridge, instructions to the user and the like. According to one practice of
the invention, test results are stored in memory in the meter and the display 23 allows a
user to view prior test results.

The meter also has on its outside buttons which can be used by the user to enter
data into the meter's electronics. This may be achieved by using the buttons to navigate
through one or more menus displayed on the display 23.
To measure blood glucose levels with the integrated meter 10, a user first depresses
the handle 21 to simultaneously cock the lancet assembly and automatically open the test
strip cartridge and to advance a test strip from the cassette to the feeding channel 19. The
user then presses the meter 10 against a body part, such as a finger or forearm, such that
the skin of the user contacts the lancing cap 16. When a user pushes the trigger button 15,
the lancet assembly fires the lancet 13 into the skin a predetermined depth and at a precise
location. The lancet assembly immediately retracts the lancet from the skin.
The lancing cap 16 includes a pressure ring (not shown) so that, as the meter is
pressed onto the skin after the lancing has taken place, a drop of blood of the required size
forms on the user's skin. As the blood drop grows, the blood contacts the sample-receiving
area of the test strip and capillary force absorbs blood into the strip for analysis. The user
holds the meter firmly against the skin until a sufficient amount of blood is absorbed into
' the test strip, generally for about 3 to 10 seconds. According to one practice, the meter 10
produces an audible or visible signal to the user indicating that a sufficient blood sample
has been collected and that analysis has begun. The user then removes the meter from the
skin and the electrochemical analysis of the sample continues until the result is displayed.
Referring to Figures 3 and 4, the disposable strip cartridge 18 includes a number of
components designed to facilitate automatic, one-by-one dispensing of the test strips.
According to the illustrated embodiment, the test strip cartridge includes a vial housing 30,
a cartridge housing 31 including a stack of test strips 32, a cartridge cap 33 and a push-up
or biasing mechanism 35. It is readily seen that the cassette housing 31 is disposed within
the vial housing 30 in use, and that the cartridge cap 33 acts to close the vial housing. The
push-up mechanism 35 is also disposed within the vial housing. As shown, the stack of
test strips comprises about fifty test strips in vertical alignment. However, the test strip
cartridge of the present invention is not limited to a stack of fifty test strips and may
include any number of stacked test strips.
The push-up 35 mechanism biases the test strip stack 32 towards the cartridge cap
33 such that when a foremost test strip 32a 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 up and is ready to be dispensed for a subsequent analysis.

The push-up mechanism includes a loader 34 pressing against the last strip in the stack 32
and a biasing element, illustrated as tensator 35A. As illustrated, the tensator 35A
comprises a constant force clock spring that applies a constant pressure to the stack. The
push-up mechanism may also be provided with a non-return ratchet mechanism, or the
like, active upon the loader 34 to prevent the loader 34 from moving back down within the
cassette housing 31 and thus causing the top strip 32 to leave the ready-to-be-dispensed
position. The ratchet may take the form of an array of appropriately shaped protuberances
disposed inside the cassette housing 31 and co-operative with protuberances upon the
loader 34 exterior.
The push-up mechanism 35 further includes a tensator retainer 36 to secure a
portion of the tensator to the cassette housing. The vial housing 30 further includes
notches 37 to releasably lock the cartridge in the modular housing of the meter. When
loading the cartridge 18 into the meter, the vial housing clicks unambiguously in place to
ensure a precise fit.
The cartridge cap 33 includes a hermetic sealing element 38 which contacts the vial
housing to form a seal to protect the test strips from humidity, which can damage the test
strips and compromise test results. Alternatively, the seal can be included in the vial
housing where it meets the cap.
According to one practice, the cartridge material itself can have desiccant
properties, or desiccants can be disposed in the interior space of the vial. Any humidity
that may migrate into the test strip vial is by these materials absorbed and neutralized.
Preferably, the cartridge includes on it a re-writable memory module such as an
EEPROM chip. In this case, the electronics in the meter will include means for interfacing
with the memory module so that the meter can read from and write to the memory module.
The memory module will contain a calibration code for the cartridge and will
preferably contain a unique code for the cartridge and its expiry date. It may also contain
compensation factors for analyses of different fluids (such as venous, arterial or neonatal
blood or interstitial fluid), the number of strips in the cartridge and other relevant
information. The electronics in the meter will be set up to use any data stored in the
memory module, in particular the calibration code.
The electronics will also be set up to write to the memory module such information
as the number of strips used, the length of time the cartridge cap has remained open, the

date of first opening the cap, the date and times of each test carried out and the result of the
test.
The cartridge may alternatively include such data in other formats, such as in
visible characters, as a bar code or as a resistor bridge circuit.
As shown in Figures 4, 5a, 5b, 5c, 31, 32, 33 and 34 the cartridge cap is releasably
locked into place on the cartridge by a cap retainer 39. To allow for the strip dispensing
mechanism in the meter to forward individual strips to the feeding channel 19, the
cartridge cap 33 includes a "pop-up" feature. The cartridge cap 33 is flexibly attached to
the vial housing 30 by means of side supports, hinges, springs or another suitable
mechanism. Pushing the cap retainer 39 releases the lock on the cartridge cap and allows
the cap to pop up a predetermined amount, thereby allowing the foremost test strip 32a in
the stack 32 to be fed to the sample-receiving position. As may be seen in Figures 5a to 5c,
the lock may be released by pushing the locking member 39 such that it moves as a whole,
thereby moving out of locking contact with the cap 33. Alternatively, as seen in Figures 31
to 34 the retainer or retainers 39 may be bent away from the vial housing 30, by an
outward pressure exerted by one or more arms 21a inserted between the retainer 39 and the
vial housing 30 for example, thereby releasing their locking hold and allowing the cap 33
to "pop-up".
The strip dispensing system 20 of Figure 1 cooperates with the pop-up cartridge
cap described above to push the foremost test strip of a test strip stack into the feeding
channel 19 in order to position the test strip in the sample-receiving position with its
sample-receiving area in close and precise proximity to a puncture site. As discussed, the
strip dispensing system 20 comprises a multi-function handle 21.
Figure 6 is a view of the integrated meter in an idle position. Figure 7 illustrates
the integrated meter when the multi-function handle is depressed. In the idle position, the
cap retainer 39 forces the cartridge cap 33 closed and securely connects the cartridge cap
33 to the body of the test strip cartridge. The multi-function handle 21 comprises a lever
21a (see also Figures 31 to 34) and when a user depresses the lever, the lever disengages
the locking mechanism on the cartridge cap 33. As illustrated, a cap opening spring 40
inside the handle lever 21 pushes on the cap retainer 39 to release the cap 33 from the
cartridge body and expose the slider slot behind the foremost test strip within the test strip
cartridge. At the same time the handle lever 21a actuates a slider 41, which slides behind

the foremost test strip and pushes the foremost test strip into the feeding channel 19 of the
meter 10.
According to the illustrated embodiment, the slider is a rotating flexible slider 41
and the drive element for the slider 41 includes a device, illustrated as a ratchetwheel in
cooperation with a cog 42, to ensure that the foremost test strip is completely pushed into
the feeding channel before another test strip can be dispensed. The slider 41 only returns
to its original position when the foremost test strip has been properly and accurately placed
into the feeding channel and is in the sample-receiving position.
Those skilled in the art will recognize that any suitable mechanism may be utilized
for forwarding a test strip into a feeding channel and ensuring that the test strip is entirely
dispensed. Once in the feeding channel, the test strip is positioned to receive a blood
sample for analysis. After the analysis is complete, the user replaces the cartridge cap 33
to re-seal the cartridge. According to one practice of the invention, closing the cartridge
cap 33 ejects the used test strip from the meter 10. This may be achieved by a contoured
protrusion 33a from the cap 33, as shown in Figures 31 to 34. The protrusion may be in
abutment with the rear of the in use strip or may be brought into abutment therewith during
closing of the cartridge cap 33. In this embodiment, the protrusion is contoured to
progressively force the strip out of its sample-receiving position as the cap 33 closes,
thereby ejecting the used strip and clearing the way for a new strip to be loaded during the
next operation of the apparatus.
As illustrated, the multi-function handle 21 further includes a cocking lever 43 for
arming the drive train 14 of the meter 10 when the handle is depressed. According to one
practice, the multi-function handle further operates to switch on the electronics (not
shown) of the meter 10 to prepare the meter for analysis of a prospective blood sample.
According to an alternate embodiment, the electronics include a strip detector for detecting
the presence of a test strip in the feeding channel. Thus, when the strip detector detects a
strip in proximity to the lancing site, the electronics switch on.
According to one aspect, the strip dispensing system 20 is designed to ensure that
only one test strip is loaded at a time. The strip dispensing system 20 includes a deviator
44 in co-operation with the slider 41. The strip dispensing system 20 allows only one test
strip to be forwarded at a time. After the handle 21 is released and the slider 41 is brought
back into its initial position, as shown in Figure 8, the deviator 44 automatically rotates
into a position to deflect subsequent attempts to load an additional test strip into the

feeding channel. The release of the cartridge cap caused by depression of the handle
allows the deviator to rotate once the slider is moved back to its idle position. After
forwarding one test strip, the slider route is deviated inside the cartridge cap 33, rather than
through the test strip cartridge and into the feeding channel of the meter 10.
When the user presses the cartridge cap 33 closed, thereby ejecting the used test
strip, the deviator rotates back and resets the strip dispensing system to dispense a new
strip. As illustrated in Figure 9, if a test strip is already loaded into the feeding channel 19,
additional squeezing of the handle 21 only serves to cock the lancet assembly 14 and does
not load another test strip into the channel. In this manner, the strip dispensing system 20
allows several cocking and lancing attempts using the same test strip. This feature is
particularly useful if the lancet is accidentally discharged or if the lancing action does not
generate a sufficient amount of blood. In this case, the lancet assembly can be re-cocked
without wasting a test strip.
The test strip cartridge 18 and the strip dispensing system 20 co-operate with the
lancet assembly illustrated in Figure 1 to efficiently and less painfully obtain and analyze a
blood sample from a user. As discussed above, squeezing handle 21 simultaneously cocks
the lancet assembly and forwards a test strip from the cassette into the feeding channel 19.
Referring again to Figure 6, the lancet assembly is in a neutral position prior to sampling.
The drive train 14 of the lancet assembly comprises a drive tube, a lancet holder slidably
mounted in the drive tube for holding the lancet 13, a first spring for urging the lancet
holder forward, a second spring for retracting the lancet 13 after the lancet punctures the
skin, a trigger button 15 and a depth adjuster knob 17. The lancet assembly further
includes a lancet cap 16 having an aperture for guiding the lancet 13 through the aperture
to the skin of a user and for shielding the lancet when not in use. Initially, the foremost
test strip 32a within the test cartridge is also in a neutral position.
In one embodiment, the first spring is a hard spring and the second is a soft spring.
In this instance, the residual momentum of the lancet, supplied by the first spring upon
urging forward the lancet, causes the compression of the second spring. This compression
begins when penetration of the skin by the lancet occurs. Once the force of the second
spring on the lancet outweighs the residual momentum, the second spring causes the
retraction of the lancet.
When the handle lever 21 is depressed, as illustrated in Figure 7, the cocking lever
43 retracts the drive tube to arm the lancet assembly, while simultaneously the test strip is

fed through the feeding channel 19 and into the sample-receiving position within the lancet
cap 16. The test strip is precisely located relative to the lancet 13. The user presses the
lancet cap 16 against a body part, such as a finger or arm, and depresses the trigger button
15 to allow the lancet assembly to drive the lancet tip into the skin, in close proximity to
the sample-receiving area of the test strip. The lancet assembly subsequently retracts the
lancet tip from the skin.
The pressure ring squeezes the skin to maximize the quantity of blood formed from
a puncture. Once the drop of blood is large enough, it will touch the sample-receiving area
of the strip and will be wicked into the strip. The test strip automatically directs the blood
sample to an analysis portion and the analysis of the blood sample begins automatically.
After the analysis is complete, the user may remove the lancet cap 16 and the lancet
13 from the lancet holder. The user may then discard the lancet 13, if desired. Those
skilled in the art will recognize that alternate lancet assemblies may be utilized in
accordance with the teachings of the present invention. For example, the present invention
is not limited to the dual-spring drive train of the illustrative embodiment of the invention.
Figures 10 through 27 illustrate different embodiments of the design for the lancet
cap 16 of the present invention. The cap 16 for the integrated meter 10 includes a cap
body 50 having a proximal end 51 for connecting to the housing 11 of the lancing device
and a contact ring 52 attached to the distal end of the cap body. The contact ring 52
includes an aperture 45 for a portion of the lancet 13 of the lancing device to pass
therethrough. The contact ring 52 has a multi-contoured surface 53 oriented generally
about an axis distinct from the axis of motion of the lancet 13. The multi-contoured
surface is designed to pressure the dermal tissue to facilitate expression of a fluid sample
after lancing the dermal tissue.
Referring to Fig. 10, the cap body 50 can include a connector 54 for removably and
replaceably connecting the proximal end of the cap body to the housing 11 of the
integrated meter 10. The connector 54 preferably is threaded to mate with corresponding
threads provided in the housing 11 of the device 10. One skilled in the art will recognize
that alternative connecting mechanisms may be used without departing from the scope of
the present invention. For example, the connector 54 can be sized and shaped to snap-fit to
the housing 12. In addition, the cap 16 can be permanently affixed to the housing 11,
although it is preferable for the cap to be removably and replaceably connected to the

housing 11. The cap body 50 and the contact ring 52 can be constructed from plastic or
other materials suitable for use in a medical instrument.
Referring to Figures 11 and 12, the contact ring 52 preferably has a multi-contoured
surface 53 for contacting the dermal tissue both during lancing and during blood sample
expression. The multi-contoured surface 53 is oriented generally about an axis, indicated
by line B in Figure 12. According to the illustrative embodiment, the lancet travels along a
first axis and the multi-contoured surface is oriented about a second axis perpendicular to
the axis of motion of the lancet. One skilled in the art will recognize that the second axis is
not limited to this preferred orientation and that any orientation distinct from the axis of
motion of the lancet can be employed.
The multi-contoured surface 53 is designed to pressure the dermal tissue to
maximize blood flow rate from the periphery of the pressured area to the center of the
lancing site and to facilitate the expression of a blood sample for collection. The term
multi-contoured surface as used herein can comprise two or more surfaces oriented at
distinct angles with respect to each other and with respect to a common axis. The multi-
contoured surface can extend inwardly from a vertical wall, orcan extend inwardly from a
flat surface extending radially inwardly from the vertical wall. Those of ordinary skill will
recognize that the multi-contoured surface can include any selected number of surfaces.
The surface can be, according to one practice, non-planar. In one embodiment described
herein, the multi-contoured surface 53 is comprised of an outer radial portion 54 and an
inner radial portion 56 proximate the opening 45. The outer radial portion 54 is preferably
oriented at a first angle C relative to the second axis B. The inner radial portion 56 is
preferably oriented at a second angle D, distinct from the first angle C, relative to the axis
B. The outer radial portion 54 and the inner radial portion 56 can have any selected
surface feature or shape, e.g. can be linear, stepped or curved. In the embodiment
illustrated in Figure 12, the outer radial portion 54 is generally linear from the perimeter 58
of the contact ring 52 to the intersection with the inner radial portion 56. Alternatively, the
outer radial portion 54 can be convex or concave in curvature. Additionally, the inner
radial portion 56 is generally concave in curvature, but can also be linear or convex.
In an illustrated embodiment, the angle C, corresponding to the slope of the outer
radial portion 54, is in the range between about 5° and about 15°. Additionally, the radial
extent of the outer radial portion 54, generally illustrated by line E in Figure 11, is
preferably about 25% to about 75% of the total radius of the contact ring 52, as measured

from the center point CP of the contact ring 52 to the perimeter 58 of the contact ring 52.
In a preferred embodiment, the radial extent E of the outer radial portion 54 is preferably
about 50% of the total radius of the contact ring 52.
The contact ring 52 can be a separate, discrete component affixed to the cap body
50 or can be integrally formed with the cap body 50.
With reference to Figure 13, the contact ring 52 of the cap 16 is sized and
dimensioned to be placed in intimate facing contact with the skin of the user. When placed
thereagainst, the contact ring creates a pressure gradient that extends from the radial outer
surface inwardly towards the opening 45. Specifically, when the skin is lanced by the
lancet 13, the contact ring 52, which is disposed about the lancing site, creates a pressure
gradient that urges fluid to flow toward the opening 45, as indicated by arrows 59.
The pressure profile 61 created by the cap 16 has pressure peaks 63 that coincide
with the perimeter portion of the cap, or with the start of the multi-contoured surface 53.
The pressure is a maximum at this portion since the cap contacts the skin of the user to a
greater degree. When the surfaces of the multi-contoured surface extend inwardly towards
the opening 45 and away from the skin, the overall pressure decreases. This forms a
pressure gradient that extends from the outermost portion of the cap 16 to the opening 45.
Those of ordinary skill will recognize that the pressure profile will change as a function of
the configuration of the contact ring.
Fig. 14 illustrates another embodiment of the contact ring 52 of the cap 16 of the
present invention. Like reference numerals designate like or similar parts plus a
superscript prime. The illustrated contact ring 52' has an axially or vertically extending
outer wall or perimeter 58' that terminates at a distal end 57. The distal end 57 includes a
first flat face portion 57A that is adapted to press against the skin of the user during use.
The flat face portion 57A is generally perpendicular to the perimeter portion 58'. The
multi-contoured surface 53' extends radially inwardly from the flat face portion 57A
towards the opening 45'. The multi-contoured surface 53' extends between the annular flat
face portion 57A, as indicated by the designation L.
The illustrated multi-contoured surface 53' includes two or more surfaces oriented
relative to each other to form different, distinct angles. In particular, the multi-contoured
surface 53' includes a pair of surfaces 65 and 67. The radially outer surface 65 is oriented
at a first angle relative to the axis B. The radially inner surface 67 is oriented at a second

angle relative to the axis B different from the first angle. As described above, the surfaces
65 and 67 can have any selected shape or angle.
In use, the cap 16 is connected to the housing 11 of the meter 10 and the dermal
tissue is lanced by the lancet 13 passing through the opening 45 in the contact ring 52. The
lancet 13 is then withdrawn into the housing 11. The contact ring 52 is pressed into
contact with the dermal tissue proximate the lancing site causing blood to exit the lancing
site and enter the cap 16 through the opening 45. Dermal tissue is "squeezed" into contact
with the outer radial portion 54 and the inner radial portion 56 of the multi-contoured
surface 53. The multi-contoured surface 53 facilitates blood expression by increasing the
pressure on the dermal tissue in contact with the perimeter 58 of the contact ring 52. The
pressure on the dermal tissue decreases as the slope of the outer radial surface 54 and the
inner radial surface changes toward the opening 45. This inwardly extending pressure
gradient is illustrated in Figure 13.
An alternative embodiment of the cap is illustrated in Figures 15 through 19 in
which a sleeve 70 is mounted about the cap body 50. The sleeve 70 is movable generally
along a first axis A, i.e. along the axis of motion of the lancet, and relative to the cap body
50. The sleeve 70 comprises an annular collar 72 and at least two legs 74A and 74B that
extend from the collar 72 in the direction of the first axis A toward the distal end of the cap
16. The legs 74A and 74B taper from an increased width proximate the collar 72 to a
decreased width proximate the contact ring 52.
As illustrated in Figure 16, the legs 74A and 74B are arcuate in cross-section and
encompass only a portion of the circumference of the contact ring 52. The legs 74A and
74B are preferably symmetrically disposed about the circumference of the contact ring 52.
Although only two legs are illustrated in the Figures, one skilled in the art will appreciate
that additional legs can be added without departing from the present invention. In addition,
the legs need not be positioned symmetrically about the contact ring 52.
The sleeve 70 is preferably slidable along an axis parallel to the first axis A, as
indicated by arrow T in Figure 15. A longitudinally extending slot 76 can be formed in
one or both of sides of the cap body 50. A protruding guide member 78 can be formed in
one or both of the legs 74A and 74B. The guide member 78 is sized and shaped to slide
within the slot 76 and inhibits lateral motion of the sleeve 70 relative to the cap body 50.
Alternatively, the slot 76 can be formed in one or more of the legs 74A and 74B and the
guide member 78 can be formed on the cap body 50.

A spring 79 or other biasing mechanism can be provided to bias the sleeve 70
toward the distal end of the cap 10.
It is sometimes desirable to remove the cap 16 and the contact ring 52 from contact
with the dermal tissue after lancing, for example, to remove pressure from the dermal
tissue or to visibly inspect the lancing site. The sleeve 70 allows the user to maintain a
portion of the lancing device, the legs 74A and 74B of the sleeve 70, in contact with skin
when the cap 16 and the contact ring 52 are removed from contact with skin, as illustrated
in Figure 17. Importantly, the legs 74A and 74B allow the user to maintain the opening 45
in alignment with the lancing site when the contact ring is returned into contact with
dermal tissue, as illustrated in Figure 18.
Referring to Figure 19, the legs 74A and 74B can be spaced apart a distance
sufficient to allow a finger 80 of the user to fit between the legs 74 A and 74B. The surface
77 connecting the two legs 74A and 74B can be curved, and are preferably parabolic in
shape, to further fitting of the user's finger 80. In addition, the legs 74A and 74B, as well
as the sleeve 70, can be constructed from a flexible, resilient material, such as a flexible
plastic. The preferred material of choice is ABS plastic. As illustrated in Figure 19, the
user's finger 80 can be positioned between the legs 74A and 74B when the sleeve 70 is
positioned beneath the cap 16. The legs 74A and 74B compress the user's finger
therebetween to pinch or squeeze the dermal tissue. The user's finger can then be lanced
and the compression of the user's finger by the legs 74A and 74B can facilitate the
expression of blood from the lancing site.
Alternate embodiments of the cap are illustrated in Figures 20 to 23, in which the
contact ring 52 is designed for lancing the sharp curve (or side) of the fingertip, as well as
the ventral side of the fingertip.
Figures 20 and 21 illustrate another embodiment of the lancet cap suitable for Use
with the present invention. The cap 16 includes a cap body -91 having a proximal end 96.
A contact ring 95 is attached to the distal end 93 of the cap body 91. An opening 90 is
provided in the contact ring 95 to allow a portion of the lancet 13 to pass through to effect
puncturing of the fingertip. The illustrated cap body 91 can include a connector 94 for
removably and replaceably connecting the proximal end 96 of the cap body 91 to the distal
end of the housing 11 of the device 10 For example, the connector 94 can be sized and
shaped to fit the housing 11. The lancet cap 16 can be permanently affixed to the housing

11 although it is preferable that the lancet cap 16 be removably and replaceably connected
to the housing 11.
The contact ring 95 preferably employs a pair of pressure wings 92 sized and
dimensioned to accommodate the sharp curve of the fingertip therebetween. The pressure
wings 92 thus form a recess 97 for accommodating the finger of the user. This applies the
correct amount of pressure to allow for the expression of blood.
Referring to Figure 21, pressure wings extend radially outward and away from the
contact ring for contacting the fingertip both during lancing and during blood sample
expression. The pressure wings 92 constitute a multi-contoured surface that extends from
the outer periphery of the body 91 to the opening 102. The multi-contoured surface 98 is
designed to pressure the fingertip to maximize blood flow rate from the lancing site and to
facilitate the expression of blood for sample collection. The illustrated multi-contoured
surface 98 comprises two or more non-planar surfaces disposed at distinct angles relative
to each other and with respect to a common axis. For example, the pressure wings 92 that
constitute the multi-contoured surface 98 is comprised of a radial outer portion 98 A and a
curved radial inner portion 98B proximate to the opening 102. The transition point
between the surfaces 98A and 98B can be arcuate, rounded, or sharp.
When in use, the lancet cap 16 illustrated in Figures 20 and 21 is connected to the
housing 11 of the meter 10 of the present invention, and the. fingertip of the user is placed
in the recess 97 formed by the pressure wings 92. The lancet 13 of the device is deployed
and passes through the opening 102 in the contact ring 95 to pierce the skin. The contact
ring 95 is pressed into contact with the fingertip proximate to the lancing site to express
blood. The multi-contoured surface facilitates blood expression by creating a pressure
gradient that extends radially inwardly towards the opening 102.
Figures 22 and 23 illustrate another embodiment of the lancet cap of the integrated
blood sampling and testing meter according to the teachings of the present invention. As
illustrated in Figure 22, the lancet cap 16 includes a contact ring 105 attached to the distal
end 107 of the cap body 104. An opening 101 formed in the contact ring 105 allows a
portion of the lancet 13 to pass therethrough to create a puncture on the ventral side of the
fingertip.
The illustrated contact ring 105 has a multi-contoured surface 106 that extends
from the periphery of the cap body 104 to the central opening 101. The multi-contoured
surface 106 can include two or more surfaces disposed at distinct angles relative to each

other and with respect to a common axis. For example, the illustrated multi-contoured
surface 106 is comprised of an outer radial portion 106A, a middle portion 106B, and an
inner radial portion 106C disposed proximate to the opening 101. The outer, middle and
inner radial portions of the cap can have any selected surface feature or shape, e.g., can be
linear, stepped, or curved. Moreover, the transition points between each surface 106A,
106B and 106C of the multi-contoured surface can have rounded, arcuate, or sharp surface
features.
When in use, the lancet cap 16 is connected to the housing 11 of the meter 10 of the
present invention and is placed in intimate facing contact with the ventral side of the finger
which is lanced by the lancet 13 passing through the opening 101 in the contact ring 105.
The lancet 13 is withdrawn into meter 10. The fingertip is squeezed into contact with the
outer radial portion 106A, middle radial portion 106B, and inner radial portion 106C of the
multi-contoured surface 106. The multi-contour surface 106 facilitates blood expression
by creating a pressure gradient that extends radially inwardly toward the opening 101 from
the perimeter of the contact ring 105 or cap body 104.
Figures 24 and 25 illustrate another embodiment of the lancet cap for use at
multiple different lancing sites according to the teachings of the present invention. The
illustrated lancet cap 16 includes a cap body 112 that terminates at a contact ring 114
mounted at a distal end. The distal end 115 of the cap 16 can couple to the housing 11 via
any suitable structure. The contact ring 114 of the cap 16 can include, if desired, a multi-
contoured surface 118 having a plurality of surfaces oriented at angles relative to each
other. A central opening can also be formed therein. According to an alternate
embodiment, the contact ring can be a unitary structure with nominal surface features
formed therein.
The illustrated contact ring 114 is preferably formed of a deformable, resilient,
flexible material that is capable of conforming to the shape of the body region of the user
placed in contact therewith. The contact ring can be preferably formed of a rubber
material, polyurethane, latex or other flexible material. The cap body 112 can also be
formed of any suitable transparent or translucent material, such as clear or transparent
plastic, to enable the user to view the expressed blood. Alternatively, the cap can be
formed of a non-transparent material.
The contact ring 114 can be disposed in a rest position, shown in Figure 24, when
not in contact with a lancing site, and hence no shape is imparted to the ring. When placed

in contact with the lancing site, such as the ventral side of a finger, or any other suitable
portion of the finger, the contact ring conforms to the shape of the lancing site, as
illustrated in Figure 25.
According to an alternate embodiment, as illustrated in Figures 26 and 27, the
lancet cap 16 of the integrated testing meter of the present invention can include a cap
body 132 that has mounted thereto a deformable contact ring 134. The illustrated contact
ring 134 has edge portions 136 that extend over or outwardly from the perimeter of the cap
body 132. The contact ring can include, if desired, a multi-contoured surface having a
plurality of surfaces oriented at angles relative to each other. A central opening can also be
formed therein. According to an alternate embodiment, the contact ring can be a unitary
structure with nominal surface features formed therein.
The contact ring can be preferably formed of rubber material, polyurethane, latex or
other flexible material. The contact ring 134 can be disposed in a rest position, shown in
Figure 26, when not disposed in contact with a lancing site, and hence no shape is imparted
to the ring. When placed in contact with the lancing site, such as the ventral side of a
finger, or any other suitable portion of the finger, the contact ring 134 conforms to the
shape of the lancing site, as illustrated in Figure 27. Moreover, when disposed in this
position, the overhanging portions of the deformable contact ring, can 'flip' over and
extend along the outer surface of the cap body 132 so it can be used on a flatter skin area,
such as the forearm.
The cap body 132 can include a connector for removably and replaceably
connecting a proximal end of the cap body 132 to the housing 11. According to one
practice, the lancet cap 16 can be permanently affixed to the housing 11. Preferably, the
lancet cap 16 is removably and replaceably connected to the housing 11 of the integrated
testing meter 10.
The lancet cap 16 for use with the integrated sampling and testing meter of the
present invention is not limited to the illustrative embodiments described above. Those
skilled in the art will recognize that a certain changes may be made to the lancet cap
construction without departing from the scope of the invention.
A significant feature of the integrated meter of the present invention is that the strip
dispensing system automatically and accurately positions the sample-receiving area of a
test strip in close proximity to the puncture site formed by the lancet in order to provide a
sufficient blood sample with a minimal puncture wound. Puncturing very accurately and

in a defined proximity to the sample-receiving area of the test strip eliminates transfer of
the sample by the user. The test strip wicks the blood sample directly from the puncture,
allowing the use of low volume blood samples for analysis. Moreover, the test strip is
positioned to automatically and efficiently direct the sample to a defined area of the test
strip for analysis. The strip dispensing system and the feeding channel co-operate with the
lancet assembly to position the sample-receiving area of the strip about one millimeter
away from the puncture site. The precisely controlled distance between the puncture and
the sample-receiving area of the test strip defines a minimal drop size required to be
formed for analysis. When the drop of blood formed by the puncture grows to about 0.8
millimeter radius (about one microliter in volume), the drop touches the sample-receiving
area of the test strip. The test strip provides a capillary force to wick the blood drop into
the test strip. The described arrangement efficiently conveys a sample from the skin to a
precise position on the test strip with little or no loss.
According to one practice of the invention, the test strip is flexible to accommodate
deep and superficial bulging of the skin formed by the squeezing of the skin by the
pressure ring in the lancet cap. According to an alternate embodiment, the test strip is
precisely positioned above the puncture site, in the lancet path, so that the lancet first
pierces the wicking element of the test strip, then pierces the skin.
To accurately position a test strip, the feeding channel 19 of the integrated sampling
and testing device of the present invention includes a step 60, illustrated in Figure 28.
When the test strip 32a exits the test strip cartridge 18, and passes through the feeding
channel to the sample-receiving position in the lancet cap 16, the step 60 locks the strip
and prevents the strip from reversing and moving back into the test strip cartridge 18. The
walls of the feeding channel further provides lateral alignment of the strip. According to
the illustrated embodiment, the electrical contacts 22 connected to the electronics in the
device may be spring biased or otherwise arranged to lock the test strip into place behind
the step.
The cartridge cap may also include a strip ejection ramp to push the test strip out of
the feeding channel when the cap is closed. The strip ejection ramp may be integral with
the cartridge cap or removably connected to the cartridge cap.
The design of the lancet needle and the lancet assembly provides an accurate
puncture site with little variation to ensure a precise relationship between the sample-
receiving area of the test strip and the puncture site. According to one practice of the

present invention, the lancet is ground to center the point on the tip of the lancet.
According to an alternate embodiment, the lancet needle is ground at the edge, as with
current lancets. The lancet is then positioned in plastic, such that the pointed tip is located
in a fixed position in the center of the plastic. Thus, the puncture site is precisely fixed,
independent of the orientation of the drive train, and/or vibrations of the drive train. The
lancet cap further includes an alignment feature to control wobbling or vibration on the
front end of the drive train. According to an illustrative embodiment, the lancet cap
includes a plurality of alignment fins (not shown) disposed about the base of the lancet to
secure the lancet. In this manner, the total variability of the puncture site is minimized.
Figure 29 illustrates a test strip design suitable for use in the present invention. The
test strip may utilize A-strip technology, membrane strip technology or other test strip
designs known in the art for electrochemical or photometric analysis of a fluid. According
to one embodiment, the test strip 32a includes, as its sample-receiving area, a channel
entrance 141 for directing a blood sample to an analysis portion of the strip. The test strip
essentially comprises an electrochemical cell, including one or more working electrodes
142 which convert a chemical change produced by a reaction of glucose or other analyte in
the blood sample to a current. The test strip further includes a reference electrode 143 as a
standard to measure the potential of the working electrodes. Leads 144 connect the
electrodes to contact bars 145 configured to connect with the electrical contacts 22 of the
integrated testing meter. The test strip thus generates a signal indicative of the level of
glucose or other analyte in the blood and transmits this signal to the electronics of the
device for processing. Those skilled in the art will recognize that a variety of test strip
designs and configurations are available in accordance with the teachings of the present
invention.
Figure 30 shows a schematic representation of the electronics incorporated in the
integrated meter of the present invention. The electronics receive a signal from the
electrical contacts, process the signal and transmit instructions for an appropriate display to
the display of the device. As shown, input signals related to the electrochemical analysis
of the sample are provided from the test strip to a signal processing system. The signals
are transmitted via analog circuitry to a processor, which performs data analysis. The
processor provides a signal to a display driver connected to an output display. The
processor may also provide a signal to an alarm generator. The display and the alarm
generator together constitute the output portion of the device. The data analysis processor

also communicates with a memory module, such as an EEPROM, in which information,
including calibration information and previous test results, may be stored.
According to one practice of the invention/the electronics further include a detector
for sensing a strip in the feeding channel. The detector can be two contacts which are
shorted by a conductive layer on a strip when the strip is in the sample-receiving position.
The electronics may be designed to produce an audible beep or visible signal to indicate to
the user that a sufficient sample has been obtained and that analysis is complete. The
electronics may also read, store and/or display information regarding the date and time of
testing, the condition of the strips, the number of strips remaining in the stack, a calibration
code for the strips, the expiration date of the test strip cartridge, the battery power of the
meter, and so on. As noted above, test strip specific information can be read directly from
the cartridge, for instance by use of bar codes, resistance bridges or memory modules,
preferably rewritable memory modules.
As discussed, according to one embodiment, the electronics are switched on when a
user depresses the handle of the integrated testing meter, or when a test strip detector
detects a loaded test strip in the sample-receiving position. Preferably, each time the
electronics are switched on, the data on the cartridge is read to ensure that the correct
calibration code and other data are used to control the meter. This ensures that a correct
test result can be obtained even if the cartridge has been changed.
According to another embodiment of the invention, the electronics are switched off
when the user replaces the test strip cartridge cap and ejects the used test strip from the
meter. This provides an extra safety feature as it ensures that the cartridge remains closed
for as long as possible. This minimises the exposure of the contents of the cartridge to the
atmosphere. Preferably, the electronics in the meter are arranged to record the length of
time between a strip reaching the sample-receiving position and its being ejected from the
meter. This is a measure of the time the cap is open. If the total time the cap is open
exceeds a predetermined value, the electronics may be arranged to provide an audible or
visible warning signal. The electronics may also be arranged to provide such a signal, or to
switch off the meter, if any single strip has remained in the sample-receiving position for
longer than a predetermined time.
The integrated meter of the present invention and its components provide
significant improvements to the detection and monitoring of glucose levels in the blood.
The present invention considerably reduces the pain and inconvenience associated with

i
1 glucose monitoring. The invention further improves the efficiency and accuracy of testing
by providing an automated transfer and analysis of the sample. The invention provides an
integrated testing meter with user-friendly, uncomplicated operation. The integrated
testing meter is compact, economically sound, discrete and adjustable to different users
and body parts while simultaneously providing fast and accurate results.
The present invention achieves a reduction in the pain associated with testing in a
number of ways. Shallower punctures of the skin can be used to achieve a sufficient blood
sample, reducing painful deep punctures in sensitive body parts. The present invention
does not require large sample volumes, for analysis. The pressure device, for instance
formed by the pressure ring on the lancet cap, provides a high yield from a small puncture.
The integrated sampling and testing feature further ensures full usage of the obtained
sample and limits "leftovers" on the skin. In current systems, complex and inaccurate
sample transfer from a sampling point to a sample-receiving area on a test strip requires
surplus sample due to poor utilization of an obtained sample drop. The present invention
removes this inefficiency of transferring samples and provides optimal utilization of the
obtained sample by automatically directing the sample to a precise location on the test
strip. Optimal utilization of the sample drop reduces the number of attempts needed to
provide enough sample for efficient analysis, thus reducing the number of punctures
required. The superficial punctures reduce agitation of nerve endings in the skin and
reduce pain in sensitive body areas. The variable depth of the lancet and the ability to test
on a number of different body parts in addition to the finger reduces the concentration and
repetition of micro-traumata in a small area, which avoids the problems of tinting, itching,
dried and callous skin areas caused by such micro-traumata.
The integrated meter of the present invention is able fully to exploit the
technological improvements in strip design which allow the use of much smaller samples.
Presently available strips require only 1 to 3 ul of sample. Many users have eyesight
problems and cannot see well enough to be able to transfer such small volumes of sample
accurately to the sample-receiving area of a strip. Such eyesight problems are common
complications of diabetes. The automatic collection and transfer of samples to the strip
enabled by the present meter is a major advantage of the present meter.
It is thus possible to arrange the operation of the lancet and the pressure device to
produce a puncture which allows a small, but sufficient, volume of blood to be expressed

as a drop on the user's skin. Such a small drop will be able to contact the sample-receiving
area of the test strip due to the precise positioning of the lancet and the test strip.
The small volume of blood or other bodily fluid expressed from the user is
sufficient to accurately determine or monitor the presence or absence of an analyte, such as
glucose.
The present invention further provides easy and uncomplicated operation. The use
of the meter significantly reduces the time and difficulty involved in sampling and testing
blood. The integrated meter essentially provides three devices, a lancing device, a supply
of test strips and a meter, within a singular compact housing. Further, the system is
designed such that one-handed operation is possible, eliminating the need for a work space
or a flat surface. The meter is not subject to human error and inefficiency. Furthermore,
the integration of a disposable test strip cartridge makes the loading of a test strip simple,
accurate and easy. In current glucose monitoring systems a user requires two hands to load
a strip into a glucose meter. However, with the meter of the present invention, the test strip
dispensing system automatically loads a test strip in position to receive a blood sample.
The present invention also reduces waste by efficiently utilizing available resources. The
present invention further protects against compromised test results due to contamination or
an improperly calibrated glucose meter.
In conclusion, the integrated meter of the present invention significantly reduces
the obstacles associated with frequent glucose monitoring. The present invention promotes
frequent monitoring for diabetic individuals by providing a simple, efficient, fast and
accurate integrated meter.
Since certain changes may be made in the above constructions without departing
from the scope of the invention, it is intended that all matter contained in the above
description or shown in the accompanying drawings be interpreted as illustrative and not in
a limiting sense.
It is also to be understood that the following claims are to cover all generic and
specific features of the invention described herein, and all statements of the scope of the
invention which, as a matter of language, might be said to fall therebetween.

We Claim:
1. An integrated sample-testing meter (10) comprising a single modular housing
(11) carrying:
a pressure device (52);
a lancet (13);
a lancet drive train (14) for driving the lancet (13) between an extended position
and a retracted position;
a test strip cartridge (18) containing a plurality of test strips (32), each strip
having a sample-receiving area;
a sensor for analyzing a fluid sample received on a test strip (32); and
a test strip dispensing system (20) for moving test strips (32) individually from
the cartridge (18) to a sample-receiving position in which the sample-receiving
area of the test strip (32) is in proximity to the location of the end of the lancet
(13) in its extended position and in which the test strip (32) is connected to the
sensor,
the meter (10) being arranged such that, in use, when it is located on the skin of
a user and is activated, the lancet (13)is moved to its extended position and
retracted to form a puncture in the user's skin, the pressure device (52) causes a
drop of fluid to form around the puncture, a test strip (32) is moved from the
cartridge (18) to the sample-receiving position, the test strip (32) receives a
sample from the fluid drop and the sensor analyzes the sample;

characterzed in that:-
the meter (10) has a feeding channel (19) which receives the strip (32) from the
cartridge (18) and guides it to the sample-receiving position, wherein the feeding
channel (19) includes a step (60) arranged such that when the strip (32) has
been moved past the step (60), the strip drops, or is forced into the step (60),
thereby preventing the strip from moving back towards the cartridge(18).
2. The meter (10) as claimed in claim 1, which is arranged such that, in use,
when a strip (32) is in the sample-receiving position, its sample-receiving area is
spaced from the puncture site by a distance of from about 0.4mm to about 1.3
mm.
3. The meter (10) as claimed in claim 2, wherein the distance is from about 0.7
mm to about 0.9 mm.
4. The meter (10) as claimed in any one of claims 1 to 3, wherein the lancet
drive train (14) has an adjustment screw (17) which allows the user to set the
extended position of the lancet (13).

5. The meter (10) as claimed in claim 4, wherein the operation of the adjustment
screw (17) is arranged such that the distance of travel of the lancet (13) remains
constant.
6. The meter (10) as claimed in any one of claims 1 to 5, wherein the test strip
cartridge (18) comprises a cartridge housing(31) defining a cavity configured to
receive a stack of test strips (32), a partially detachable cartridge cap (33) and a
means for moving the stack of test strips (32) towards the cartridge cap (33).
7. The meter (10) as claimed in claim 6, wherein the cartridge (18) is
manufactured from a material having dessicant properties.
8. The meter (10) as claimed in any one of claims 1 to 7, wherein the strip (32)
is forced into the step (60) by springs located on the meter (10).
9. The meter (10) as claimed in claim 8, wherein the springs are electrically
conductive and are arranged to make electrical contact with electrodes or a
conductive bar on the strip (32).
10. The meter (10) as claimed in any one of claims 1 to 9, wherein the feeding
channel (19) is arranged such that the major plane of the strip (32), when in the

sample-receiving position, is at an angle of from about 30° to about 60° to the
direction of movement of the lancet towards its extended position.

ABSTRACT

Title: Integrated Sample Testing Meter
An integrated sample-testing meter (10) comprising a single modular housing (11)
carrying:
a pressure device (52);
a lancet (13);
a lancet drive train (14) for driving the lancet (13) between an extended position and a
retracted position;
a test strip cartridge (18) containing a plurality of test strips (32), each strip having a
sample-receiving area;
a sensor for analyzing a fluid sample received on a test strip (32); and
a test strip dispensing system (20) for moving test strips (32) individually from the
cartridge (18) to a sample-receiving position in which the sample-receiving area of the
test strip (32) is in proximity to the location of the end of the lancet (13) in its extended
position and in which the test strip (32) is connected to the sensor,
the meter (10) being arranged such that, in use, when it is located on the skin of a user
and is activated, the lancet (13)is moved to its extended position and retracted to form
a puncture in the user's skin, the pressure device (52) causes a drop of fluid to form
around the puncture, a test strip (32) is moved from the cartridge (18) to the sample-
receiving position, the test strip (32) receives a sample from the fluid drop and the
sensor analyzes the sample;