U.S. patent application number 14/755650 was filed with the patent office on 2015-10-22 for glucose measurement system with high-capacity cartridge and capability of more frequent replenishment.
The applicant listed for this patent is Bayer HealthCare LLC. Invention is credited to Daniel Brown, Sung-Kwon Jung, Martin Antoine Mathelier.
Application Number | 20150301016 14/755650 |
Document ID | / |
Family ID | 48694033 |
Filed Date | 2015-10-22 |
United States Patent
Application |
20150301016 |
Kind Code |
A1 |
Brown; Daniel ; et
al. |
October 22, 2015 |
GLUCOSE MEASUREMENT SYSTEM WITH HIGH-CAPACITY CARTRIDGE AND
CAPABILITY OF MORE FREQUENT REPLENISHMENT
Abstract
The present disclosure relates to packaging containers for
holding a plurality of test sensors. The packaging container may
include a first semi-circular housing and a second semi-circular
housing. The first semi-circular housing has a plurality of first
test sensor containing regions. Each of the plurality of the first
test sensor containing regions is adapted to contain at least one
test sensor having a top portion covered by a foil cover. The
second semi-circular housing has a plurality of second test sensor
containing regions. Each of the plurality of the second test sensor
containing regions is adapted to contain at least one test sensor.
The second semi-circular housing has a top portion. The first
semi-circular housing and the second semi-circular housing are
positioned adjacent to each other. The first semi-circular housing
further comprises an outer wall extending in a non-perpendicular
direction away from the top portion.
Inventors: |
Brown; Daniel; (Edwardsburg,
MI) ; Mathelier; Martin Antoine; (Garnerville,
NY) ; Jung; Sung-Kwon; (Granger, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bayer HealthCare LLC |
Whippany |
NJ |
US |
|
|
Family ID: |
48694033 |
Appl. No.: |
14/755650 |
Filed: |
June 30, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13729765 |
Dec 28, 2012 |
9097700 |
|
|
14755650 |
|
|
|
|
61581162 |
Dec 29, 2011 |
|
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Current U.S.
Class: |
221/31 |
Current CPC
Class: |
G01N 33/487 20130101;
G01N 33/48778 20130101; B65B 5/08 20130101 |
International
Class: |
G01N 33/487 20060101
G01N033/487; B65B 5/08 20060101 B65B005/08 |
Claims
1. A packaging container for holding a plurality of test sensors,
comprising: a first semi-circular housing having a plurality of
first test sensor containing regions, each of the plurality of the
first test sensor containing regions being adapted to contain at
least one test sensor; and a second semi-circular housing having a
plurality of second test sensor containing regions, each of the
plurality of the second test sensor containing regions being
adapted to contain at least one test sensor, the second
semi-circular housing having a top portion, the first semi-circular
housing and the second semi-circular housing being positioned
adjacent to each other, wherein the first semi-circular housing
further comprises an outer wall extending in a non-perpendicular
direction away from the top portion of the second semi-circular
housing.
2. The packaging container of claim 1, wherein each of the
plurality of first test sensor containing regions further comprises
an opening, and wherein the at least one test sensor in each of the
plurality of first test sensor containing regions is capable of
being ejected through the opening.
3. The packaging container of claim 2, wherein the plurality of
first test sensor containing regions further comprises a foil cover
and a cutting assembly for removing the foil cover, the cutting
assembly capable of removing the foil cover each time one of the
first test sensors is to be ejected through the opening of the
respective test sensor containing region.
4. The packaging container of claim 3, wherein the at least one
test sensor in each of the plurality of first test sensor
containing regions includes a rod configured to engage the cutting
assembly, the cutting assembly further comprising a base and a
cutting edge extending from the base, wherein movement of the base
causes movement of the cutting edge and the rod.
5. The packaging container of claim 4, wherein the rod is received
within a slot of the at least one test sensor, and wherein movement
of the cutting assembly causes movement of the test sensor.
6. The packaging container of claim 1, wherein the plurality of
test sensor containing regions has a top portion covered by a foil,
and wherein each time a test sensor is ejected from the test sensor
containing region, at least a portion of the foil covering the
individual test sensor containing region from which the test sensor
is ejected is cut and the foil covering the remaining individual
test sensor containing regions is not cut.
7. The packaging container of claim 1, wherein said first
semi-circular housing may be removed from said packaging container
and replaced with a third semi-circular housing having a plurality
of third test sensor containing regions, each of the plurality of
the third test sensor containing regions being adapted to contain
at least one test sensor.
8. The packaging container of claim 7, wherein the first
semi-circular housing may be replaced with the third semi-circular
housing while the second semi-circular housing is still in
place.
9. The packaging container of claim 1, wherein said first
semi-circular housing and said second semicircular housing combine
to form a circular cartridge.
10. A packaging container for holding a plurality of test sensors,
comprising: a first semi-circular housing having a plurality of
first test sensor containing regions, each of the plurality of the
first test sensor containing regions being adapted to contain at
least one test sensor; and a second semi-circular housing having a
plurality of second test sensor containing regions, each of the
plurality of the second test sensor containing regions being
adapted to contain at least one test sensor, the second
semi-circular housing having a top portion, the first semi-circular
housing and the second semi-circular housing being positioned
adjacent to each other, and wherein each of the test sensor
containing regions is contiguous to a first and a second test
sensor containing region on first and second sides of the test
sensor containing region along the length of test sensor containing
region.
11. The packaging container of claim 10, wherein said first
semi-circular housing further comprises an outer wall extending in
a non-perpendicular direction away from said top portion.
12. The packaging container of claim 10, wherein each of the
plurality of first test sensor containing regions further comprises
an opening, and wherein the at least one test sensor in each of the
plurality is capable of being ejected through the opening.
13. The packaging container of claim 12, wherein the plurality of
first test sensor containing regions further comprises a foil cover
and a cutting assembly for removing the foil cover, the cutting
assembly capable of removing the foil cover each time one of the
first test sensors is to be ejected through the opening of the
respective test sensor containing region.
14. The packaging container of claim 13, wherein the at least one
test sensor in each of the plurality of first sensor containing
regions includes a rod configured to engage the cutting assembly,
the cutting assembly further comprising a base and a cutting edge
extending from the base, wherein movement of the base causes
movement of the cutting edge and the rod.
15. The packaging container of claim 14, wherein the rod is
received within a slot of the at least one test sensor, and wherein
movement of the cutting assembly causes movement of the test
sensor.
16. The packaging container of claim 10, wherein the plurality of
test sensor containing regions has a top portion covered by a foil,
and wherein each time a test sensor is ejected from the test sensor
containing region, at least a portion of the foil covering the
individual test sensor containing region from which the test sensor
is ejected is cut and the foil covering the remaining individual
test sensor containing regions is not cut.
17. The packaging container of claim 10, wherein said first
semi-circular housing may be removed from said packaging container
and replaced with a third semi-circular housing having a plurality
of third test sensor containing regions, each of the plurality of
the third test sensor containing regions being adapted to contain
at least one test sensor.
18. The packaging container of claim 17, wherein the first
semi-circular housing may be replaced with the third semi-circular
housing while the second semi-circular housing is still in
place.
19. The packaging container of claim 10, wherein said first
semi-circular housing and said second semicircular housing combine
to form a circular cartridge.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/729,765, filed on Dec. 28, 2012, and claims the benefit of
the filing date of U.S. Provisional Patent Application No.
61/581,162 filed Dec. 29, 2011, the disclosures of which are hereby
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present disclosure generally relates to a packing
container for test sensors and, more particularly, to a circular
packing container for test sensors to be used in conjunction with a
liquid sample monitoring device to determine an analyte
concentration in a liquid sample.
[0003] Monitoring systems are used for determining the presence or
concentration of analytes in body fluids, such as glucose,
cholesterol, alcohol, and hemoglobin in blood, interstitial fluid,
or chemical substances in saliva. These monitoring systems require
frequent use of test sensors. The test sensors may be provided
individually, but most find it convenient to utilize a cartridge of
sensors.
[0004] Certain self-monitoring systems are portable, handheld
testing devices. The portable nature of these devices enables a
user to conveniently test their blood glucose levels wherever the
users may be. These testing devices typically include, or at least
are able to hold, test sensors or strips for testing harvested
blood or any other suitable liquid sample. The test sensors may
include a reaction area containing a reagent for producing a
measurable reaction with an analyte indicative of the presence or
concentration of said analyte. For example, some reagents may
produce a measureable reaction with glucose indicative of the blood
glucose concentration level.
[0005] Patients suffering from various forms of diabetes or any
condition resulting in abnormal blood glucose concentration levels
often need to test their blood to determine whether any corrective
action needs to be taken. For example, a patient that has detected
an irregularly high blood glucose concentration level may use
insulin to lower his or her blood glucose concentration. Failure to
take the appropriate corrective action may result in serious
adverse health effects on the individual. Given the importance of
monitoring blood glucose concentration levels, engineers and
scientists have developed self-monitoring systems with sensors
adapted to test a blood sample.
[0006] Conventional test sensors can only be used once per test. As
a consequence, users of portable, handheld self-monitoring devices
often carry a cartridge or container holding a plurality of test
sensors. Examples of cartridges designed for holding test sensors
are described in U.S. Pat. No. 5,660,791 and U.S. Patent
Application Publication Nos. 2008/0093235 and 2008/0164164, the
entire disclosures of each of which are hereby incorporated by
reference. Conventional cartridges or containers, however, may be
bulky and difficult to carry. Since users typically need to
replenish their portable self-monitoring devices often, there is a
need for improving and decreasing the size of the cartridges and
containers designed for holding test sensors. There is a particular
need for a replenishment system that allows for replenishment of
less than all of the test sensors of a given cartridge or
holder.
BRIEF SUMMARY OF THE INVENTION
[0007] The present disclosure relates to test sensor packaging
assemblies for use with a liquid sample monitoring device. The
packaging assembly is designed to hold and individually seal a
plurality of test sensors or strips. These test sensors contain a
reagent capable of producing a measurable reaction with an analyte
indicative of the presence or concentration of said analyte. The
test sensors may be used in conjunction with a liquid sample meter
to make a quantitative analysis of the analytes in the liquid
sample. Preferably, the packaging assembly includes a plurality of
housings holding the test sensors. In this manner, one of the
plurality of housings may be replaced upon exhaustion without the
need of replacing the entire packaging assembly. Typically, the
housings will complete at least a portion of a circle.
[0008] In one embodiment of the present disclosure, the packaging
assembly, which includes a first semi-circular housing and a second
semi-circular housing positioned adjacent to each other, can hold a
plurality of test sensors. Each of the first and second
semi-circular housings has a plurality of test sensor containing
regions. Each test sensor containing region is dimensioned and
adapted to hold at least one test sensor. The first semi-circular
housing has a top portion covered by a foil cover. The second
semi-circular housing has a top portion. The outer wall of the
first semi-circular housing may extend in a non-perpendicular
manner from the top portion. The first semi-circular housing may be
removed from said packaging container and replaced with a third
semi-circular housing having a plurality of third test sensor
containing regions, each of the plurality of third test sensor
containing regions being adapted to contain at least one test
sensor. During operation, breaking one foil cover only opens
individual test sensor containing regions. The first semi-circular
housing and the second semi-circular housing may combine to form a
circular cartridge.
[0009] In another embodiment, the packaging container includes at
least two housings forming a circle. Each housing has at least one
test sensor containing region adapted to contain at least one test
sensor. The housings have top portions and bottom portions that are
substantially parallel with respect to each other. Each top portion
of the housings is covered by a foil cover. The packaging container
further includes a guiding system for guiding the ejection of each
test sensor from each test sensor containing region. The guiding
system includes a guide member associated with each test sensor and
a slot defined along an outer wall of each test sensor containing
region. The slot is dimensioned to receive the guide member and the
test sensor. The guide member has a shape that allows the test
sensor to turn about degrees when ejected from the test sensor
containing region. The guide member may have a partial spiral
shape. The packaging container may only have two housings. The
outer wall of each test sensor containing region may be tapered
with respect to the top portions and bottom portions of the
housing. The guiding system may be adapted to cut the foil
cover.
[0010] The present disclosure further relates to methods for
replacing a housing of the packaging container. In one embodiment,
the method includes providing a packaging container including at
least two housings. Each housing has at least one test sensor
containing region adapted to contain at least one test sensor. The
method further includes replacing one housing of the at least two
housings with another housing while the remaining housings remain
in the packaging container.
[0011] The present disclosure further discloses another embodiment
of a packaging container for holding a plurality of test sensors.
This embodiment includes at least two housings forming a circle.
Each housing has at least one test sensor containing region covered
by a foil cover. Each test sensor containing region is adapted to
contain at least one test sensor and has a guiding mechanism for
turning the at least one test sensor about 90 degrees upon ejection
from one of the at least two housings. The guiding mechanism
includes a hollow compartment in an outer region of each test
sensor containing region. The hollow compartment includes a first
inclined wall and a second inclined wall. The first inclined wall
is oriented at an acute angle relative to the second inclined wall
so that the at least one test sensor turns about 90 degrees upon
passing through the hollow compartment.
[0012] The present disclosure further discloses another embodiment
of a packaging container for holding a plurality of test sensors
includes first and second semi-circular housings adjacent one
another. The first semi-circular housing has a plurality of first
test sensor containing regions and each of the plurality of the
first test sensor containing regions is adapted to contain at least
one test sensor. The second semi-circular housing also has a
plurality of second test sensor containing regions and each of the
plurality of the second test sensor containing regions is adapted
to contain at least one test sensor. The second semi-circular
housing has a top portion. The first semi-circular housing and the
second semicircular housing combine to form a circular
cartridge.
[0013] An alternative embodiment includes the first semi-circular
housing having an outer wall that extends in a non-perpendicular
direction away from said top portion. Each of the plurality of
first test sensor containing regions may also further comprise an
opening and the at least one test sensor in each of the plurality
is capable of being ejected through the opening. The plurality of
first test sensor containing regions may further comprise a foil
cover and a cutting assembly for removing the foil cover each time
one of the first test sensors is to be ejected through the opening
of the respective test sensor containing region. The cutting
assembly may further include a base and a cutting edge that extends
from the base. Movement of the base causes movement of the cutting
edge and a rod that engages the cutting assembly. The test sensors
may further comprise a slot constructed and arranged to receive the
rod and movement of the cutting assembly may cause movement of the
test sensor.
[0014] In an alternative embodiment, the plurality of test sensor
containing regions may alternatively have a top portion covered by
a foil and each time a test sensor is ejected from the test sensor
containing region, at least a portion of the foil covering the
individual test sensor containing region from which the test sensor
is ejected is cut and the foil covering the remaining individual
test sensor containing regions is not cut. This allows for the
remaining test sensors in the remaining plurality of test sensor
containing regions to remain intact and unexposed until a user
desires to conduct a test and use a test sensor.
[0015] In another embodiment, the first semi-circular housing may
be removed from the packaging container and replaced with a third
semi-circular housing having a plurality of third test sensor
containing regions. The first semi-circular housing may be replaced
with the third semi-circular housing while the second semi-circular
housing is still in place. Each of the plurality of the third test
sensor containing regions may be adapted to contain at least one
test sensor.
[0016] The present disclosure further discloses another embodiment
of a packaging container for holding a plurality of test sensors.
The packaging container includes at least two housings forming at
least a portion of a circle, test sensor containing regions, and a
guiding system. Each of the at least two housings have at least one
test sensor containing region. The test sensor containing regions
are adapted to contain at least one test sensor. The housings may
have top portions and bottom portions that are substantially
parallel with respect to each other and each top portion may be
covered by a foil cover. The guiding system may guide the ejection
of each test sensor from each test sensor containing region. The
guiding system may include a guide member associated with each test
sensor and a slot defined along an outer wall of each test sensor
containing region, the slot being dimensioned to receive the guide
member and the test sensor, the guide member having a shape that
allows the test sensor to rotate from a first position to a second
position when ejected from the test sensor containing region. The
guide member may alternatively have a partial spiral shape and may
also be adapted to cut the foil cover. Additionally, the outer wall
may be tapered with respect to the top portions and bottom portions
of said housing.
[0017] In alternative embodiments, the test sensor may rotate about
90 degrees when moving from the first position to the second
position. The at least two housings may further comprise opposed
sidewalls extending between the top and bottom portions. When the
at least one test sensor in each of the two housings is in the
first position, each of the at least one test sensors has a major
surface parallel to the opposed side walls and a minor surfaces
parallel to the top portion. When the test sensor is moved into the
second position, the major surface of the test sensor is parallel
to the top portion and the minor surface is parallel to the opposed
sidewalls.
[0018] In another alternative embodiment, the housings further
comprise opposed sidewalls extending between the top and bottom
surfaces. When the test sensor is in the first position, the test
sensor has a minor surface parallel to the opposed side walls and
major surfaces parallel to the top surface. When the test sensor is
in the second position, the minor surface of the test sensor is
parallel to the top surface and the major surface is parallel to
the sidewalls.
[0019] In yet another alternative embodiment, the at least two
housings includes only two housings. There may also be a cutting
assembly for cutting the foil cover. The cutting assembly may
comprise a base and a cutting edge extending from the base, wherein
movement of the base causes movement of the cutting edge across the
foil cover.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Various embodiments of the present invention will now be
described with reference to the appended drawings. It is
appreciated that these drawings depict only some embodiments of the
invention and are therefore not to be considered limiting in its
scope.
[0021] FIG. 1 is a perspective view of a test sensor packaging
assembly including two segments;
[0022] FIG. 2 is a top view of the test sensor packaging assembly
of FIG. 1;
[0023] FIG. 3 is a side cross-sectional view of the test sensor
packaging assembly of FIG. 1;
[0024] FIG. 4 is a top view of a sealing component of the test
sensor packaging assembly of FIG. 1;
[0025] FIG. 5A is a perspective view of an array of test sensor
container regions of the test sensor packaging assembly of FIG.
1;
[0026] FIG. 5B is an enlarged perspective view of a single test
sensor container region of FIG. 5A;
[0027] FIG. 6 is a perspective view of a knife assembly engaging a
test sensor positioned within a containing region of the packaging
assembly of FIG. 1;
[0028] FIG. 7 is a perspective view of a guide member attached to a
test sensor according to one embodiment of the present
disclosure;
[0029] FIG. 8 is a cross-sectional perspective view of the guide
member of FIG. 7 attached to the test sensor;
[0030] FIG. 9 is an enlarged cut-out perspective view of a single
test sensor container region with the guide member of FIG. 8;
[0031] FIG. 10 is an enlarged perspective view of the test sensor
containing region of FIG. 9;
[0032] FIG. 11 is an enlarged cross-sectional view of the test
sensor containing region with the guide member of FIG. 8;
[0033] FIGS. 12A-12C show a partial cross-sectional view of the
test sensor being dispensed from the sensor packaging assembly of
FIG. 1.
DETAILED DESCRIPTION
[0034] FIGS. 1 and 2 show an embodiment of a test sensor packaging
assembly 110 for holding a plurality of test sensors adapted for
determining a user's analyte concentration level in a fluid sample.
Although the following discussion describes the use of test sensors
for determining the glucose concentration in blood, the presently
disclosed test sensor packaging assembly 110 may contain test
sensors designed to determine the concentration of other analytes
in other types of samples. For example, test sensor 12 may
alternatively measure glucose, lipid profiles (e.g., cholesterol,
triglycerides, low-density lipoprotein (LDL) and high-density
lipoprotein (HDL)), microalbumin, hemoglobin A.sub.1C, fructose,
lactate, bilirubin, or other analytes). The analytes may be in, for
example, a whole blood sample, a blood serum sample, a blood plasma
sample, or body fluids like interstitial fluid (ISF) and urine.
[0035] Test sensor packaging assembly 110 includes at least two
housing segments 14a, 14b forming a complete circle. While the
drawings show housing segments 14a, 14b forming a complete circle,
housing segments 14a, 14b may alternatively form other shapes, such
as partly-circular, polynomial, rectangular, elliptical, oval, or
any other suitable shape. Housing segments 14a, 14b may be made of
a polymeric material in order to increase the structural integrity
of the test sensor packaging assembly 110. While the drawings show
only two housing segments 14a, 14b, test sensor packaging assembly
110 may include more than two housing segments 14a, 14b. As shown
in FIG. 1, each of the housing segments 14a, 14b may have a
semi-circular shape. In this embodiment, the two housing segments
14a,14b may be two semi-circular portions (or two halves) that when
joined together form a complete circle. In the case of greater than
two housing segments, the shape may be arced or curved.
Collectively, the housing segments 14a, 14b may form a circular
shape, leaving an internal cavity 20 within their collective
boundary. Alternatively, the housing segments 14a, 14b (or more)
may form an incomplete circle or an arc. In some embodiments, the
housing segments 14a, 14b (or more) may collectively have a linear
or rectangular configuration. Test sensor packing assembly 110 may
also have other suitable shapes, such as square, rectangular, or
oval.
[0036] Each housing segment 14a, 14b can hold a plurality of test
sensors 12 (FIG. 2). In certain embodiments, each housing segment
14a, 14b may hold between 15 and 25 test sensors 12. In one
specific embodiment, housing segments 14a, 14b can collectively
hold 30 test sensors 12, preferably split equally between the two
segments.
[0037] The segmented test sensor packaging assembly 110 may enhance
the user's experience. Typically, large-capacity conventional test
sensor packaging containers can hold less than a single-day's
supply of sensors, particularly where some of the capacity has been
previously exhausted. Accordingly, the user of these conventional
containers must carry around a full cartridge for the impending
need to replenish the onboard sensory inventory. By segmenting the
test sensor packaging assembly 110, the user can replenish the
analyte measuring system in some increments, thereby obviating the
need of carrying around a complete spare on his or her person.
[0038] Segmenting the test sensor packaging assembly 110 also
facilitates its manufacturing process. For instance, the internal
cavity 20 of the test sensor packaging assembly 110 may be more
accessible to machinery during the manufacturing process than in
conventional circular cartridges where the internal cavity forms a
portion of the cartridge.
[0039] As discussed above, test sensor packaging assembly 110
includes two or more housing segments (14a or 14b). Each housing
segment 14a, 14b has a plurality of test sensor containing regions
16. In some embodiments, each housing segment 14a, 14b may have
between 15 to 25 sensor containing regions 16 dimensioned to
receive a test sensor 12. In one embodiment, test sensor packaging
assembly 110 includes 30 test sensor containing regions 16. Each
test sensor containing region 16 is dimensioned and configured to
hold one or more test sensors 12, typically in a sideways
orientation, such that sides of the test sensor 12 are oriented
toward the top portion 116 and bottom portion 118 of the housing
segments 14a, 14b. While the test sensor containing regions 16
shown in the figures are adapted to hold only a single test sensor
12, the test sensor container regions 16 may hold more than one
test sensor 12. The test sensor containing regions 16 may each have
a slot or slit 15 extending between an inner periphery or diameter
112 and an outer periphery or diameter 114 of the test sensor
packaging assembly 110. Slot 15 is dimensioned to receive at least
one test sensor 12 to eject the test sensor 12 from the housing
segment 14a or 14b.
[0040] As seen in FIGS. 1 and 2, each housing segment 14a, 14b may
include desiccant cavities 26 in fluid communication with each of
the corresponding test sensor containing regions 16. Desiccant
material "D" is disposed in the desiccant cavities 26 to maintain
an appropriate humidity level in the test sensor containing regions
16, thereby avoiding potentially adverse effects on the reagent
material in the test sensors 12. In certain embodiments, each
desiccant cavity 26 may be in fluid communication with only a
single test sensor containing region 16. Consequently, a test
sensor containing region 16 can be maintained at the appropriate
humidity level, even when another test sensor containing region 16
is opened. For example, the opening of one test sensor containing
region 16 of a housing segment 14a or 14b may not affect another
test sensor containing region 16. The desiccant material "D" may be
in the form of a bead. Alternatively or additionally, housing
segments 14a, 14b may be made or molded from a desiccant-containing
resin. As discussed below with regard to FIG. 4, a plurality of
foil covers 124 are secured over the housing segments 14a, 14b to
seal each test sensor containing region 16. Each foil cover 124 may
seal a corresponding housing segment 14a, 14b. Accordingly, the
number of foil covers 124 may correspond to the number of housing
segments. In particular, foil covers 124 seal the top and/or bottom
portions 116, 118 of the housing segments 14a, 14b, as well as the
outer periphery 114. Each housing segment 14a, 14b may be covered
by more than one foil cover 124.
[0041] With reference to FIG. 3, test sensor packaging assembly 110
may include an outer periphery 114 defining an oblique angle
.theta. relative to its top portion 116 and bottom portion 118.
Angle .theta. may range between 4 and 8 degrees. In some
embodiments, angle .theta. may be about 6 degrees. Outer periphery
114 also defines an angle .alpha. between its first end 114a
adjacent to the bottom portion 118 and its second end 114b adjacent
to the top portion 116. Angle .alpha. may range between 170 and 178
degrees. In certain embodiments, angle .alpha. may be about 174
degrees. The angled outer periphery 114 of the test sensor
packaging assembly 110 obviates the need for a cutting edge on the
test sensor 12. As discussed in detail below, foil cover 124 is cut
at two locations when a test sensor or strip 12 is ejected from the
test sensor containing region 16. During ejection, a blade or knife
166 severs a portion of foil cover 124 located along the slit 15 of
each test sensor containing region 16, and the test sensor 12
punctures the portion of the foil cover 124 covering the outer
periphery 114 of the housing segment 14a or 14b. Conventional test
sensors or strips 12 usually have an angled leading face to
facilitate piercing the portion of the foil cover 124 covering the
outer periphery 114 of the housing segments 14a, 14b during
ejection. In one of the presently disclosed embodiments, however,
the outer periphery 114 of the housing segments 14a, 14b is angled
relative to top or bottom portions 116, 118 to facilitate
puncturing the foil cover 124 with the ejecting test sensor 12. In
such embodiment, the test sensor 12 does not necessarily have an
angled leading face.
[0042] FIG. 4 illustrates a foil cover or sealing component 124
configured and dimensioned to cover at least the top portion 116
and outer periphery 114 of the test sensor packaging assembly 110.
Foil cover 124 may also be dimensioned to cover the inner periphery
112 of the test sensor packaging assembly 110. When foil cover 124
is placed over the top portion 116 of the test sensor packaging
assembly 110, it seals the test sensors 12 within the test sensor
containing regions 16. In the embodiment depicted in FIG. 4, foil
cover 124 includes an inner folding line 126 and an outer folding
line 128. The inner folding line 126 and the outer folding line 128
may have circular shapes, or shapes matching the test sensor
packaging assembly 110. During assembly, foil cover 124 may be
folded along the folding lines to ensure that it covers at least a
portion of the inner periphery 112 and the outer periphery 114 of
the test sensor packaging assembly 110. Foil cover 124 may be
secured to the housing segments 14a, 14b by any suitable means. For
example, foil cover 124 can be heat-welded or glued to the housing
segments 14a or 14b.
[0043] FIG. 5A depicts an array of test sensor containing regions
16, while FIG. 5B shows a single test sensor containing region 16.
Test sensor packaging assembly 110 includes a guiding mechanism 150
for each test sensor containing region 16. Guiding mechanism 150
can guide the movement of the test sensor 12 relative to the test
sensor containing region 16. As seen in FIG. 5B, guiding mechanism
150 includes a slot 152 positioned on an outer surface 17 of the
test sensor containing region 16 and a guide member 154 associated
with the test sensor 12. Guide member 154 is dimensioned to
slidably pass through slot 152. As discussed in detail below, guide
member 154 has a particular shape (e.g., partial spiral) to guide
the ejection of the test sensor 12 from test sensor containing
region 16, causing the test sensor 12 to turn or rotate about 90
degrees when ejected from the test sensor containing region 16. In
this regard, a test sensor 12 is stored in the housing segment 14a
or 14b in an upright position with its sides or the minor surfaces
of the test sensor 12 facing toward the top and bottom portions
116, 118, respectively, and the major surface of the test sensor
(or the testing surface) facing the respective sidewalls 19,21.
This allows for the test sensor 12 to be presented to a user in a
rotated orientation such that it is oriented for use in its typical
flat orientation. It is to be appreciated that in alternative
embodiments, the guide member 154 can also take on alternative
configurations if it is desired to orient the test sensor 12 in a
manner where the test sensor is not turned or rotated 90 degrees.
For example, it may be desired to turn the test sensor less than 90
degrees or more than 90 degrees. Furthermore, in an alternative
embodiment (not shown), it may be desired to first store the test
sensor 12 so that the sides or minor surfaces of the test sensor 12
are parallel to the sidewalls 19,21 and the major surface (or
testing surface) is parallel to the top and bottom portions
116,118. This wall cause the test sensor to be rotated onto its
side when ejected from the test sensor containing region 16.
[0044] As shown in FIG. 5B (and FIGS. 1-2), the test sensor
containing region 16 has a tapered shape. The guiding mechanism 150
has a width W1 that is greater than the width W2 of the rear
portion 22 of the test sensor containing region 16 wherein the test
sensor 12 is stored. In this embodiment, the sidewalls 19,21 that
extend between the top portion 116 and bottom portion 118 of the
test sensor containing region 16 are tapered in the region between
the guide member 154 and rear portion 22. The overall tapered shape
of the test sensor containing region 16 lends itself to the
cartridges 14a,14b having a semi-circular shape. In other
embodiments, the test sensor containing region 16 may not include a
taper and instead have a continuous width throughout. A test sensor
containing region 16 may be more desirable in embodiments where the
cartridges are not semi-circular.
[0045] With reference to FIG. 6, test sensor packaging assembly 110
includes one or more excision knife assemblies 160 for ejecting
test sensors 12 from the test sensor containing regions 16. Each
test sensor 12 includes an ejection member or rod 162 configured to
engage the excision knife assembly 160. Rod 162 is attached to the
first end 12a of test sensor 12. In some embodiments, the first end
12a of test sensor 12 includes a notch or undulation 15 configured
and dimensioned for securely receiving the ejection rod 162. Knife
assembly 160 includes a base 161 and a knife or blade 166
protruding from the base 161. Knife 166 is adapted to cut foil
cover 124 and push (or pull) test sensor 12 as the base 161 is
moved along a test sensor containing region 16. Ejection rod 162 is
adapted to move along with knife assembly 160. Although FIG. 6
shows knife 166 extending into the test sensor containing region 16
from the bottom portion 118 of the test sensor packaging assembly
110, knife 166 may alternatively extend into the test sensor
containing region 16 from rear or top portion 116 of the test
sensor packaging assembly 110. As discussed in detail below, test
sensor 12 can be ejected from test sensor containing region 16 upon
movement of knife assembly 160.
[0046] As seen in FIG. 7, the second end 12b of test sensor 12 may
have an angled face 13 relative to the test sensor sides. In some
embodiments, however, the second end 12b of test sensor 12 has a
straight face parallel to the test sensor sides. Regardless, a
guide member 154 is attached to the second end 12b of test sensor
12. Alternatively, guide member 154 may be monolithically formed
with test sensor 12. In the embodiment depicted in FIG. 7, guide
member 154 has a partial spiral shape that orients test sensor 12
along a plane substantially parallel to the top portion 116 of test
sensor packaging assembly 110 upon ejection. During ejection, as
guide member 154 passes through slot 152, test sensor 154 is turned
about 90 degrees.
[0047] With reference to FIGS. 8-11, a test sensor containing
region 16 includes a guiding mechanism 151 therein for turning the
test sensor 12 about 90 degrees during ejection. Guiding mechanism
151 includes a hollow compartment 153 located in an outer region
155 of the test sensor containing region 16. The outer region 155
of the test sensor containing region 16 includes outer wall 17, and
two opposite sidewalls 19 and 21. The guiding compartment 153 is
configured and dimensioned to receive the test sensor 12 and has a
first inclined wall 157 and a second inclined wall 159 (FIG. 11).
The first and second inclined walls 157, 159 collectively define a
cavity leading to slot 152. The first inclined wall 157 is adjacent
to the sidewall 19 of the outer region 155 and extends downwardly
along the sidewall at an acute angle in relation to the outer wall
17. In some embodiments, the first inclined wall 157 may be in
contact with an inner surface of the sidewall 19. The second
inclined wall 159 extends from the first inclined wall 157 to the
sidewall 21 of the outer region 155 at an acute angle relative to
the sidewall 21. In some embodiments, the second inclined wall 159
may be in contact with the sidewall 21 of the outer region 155.
[0048] During ejection, the test sensor 12 is pushed toward the
cavity of the hollow compartment 153. Upon entering the hollow
compartment 153, the top portions of the test sensor 12 engages the
first wall 157. As the test sensor moves towards the slot 152, the
first wall 157 urges the top portion of the test sensor 12
downwardly. As a consequence, the bottom portion of the test sensor
is urged toward the sidewall 21. At this point, the test sensor 12
begins to turn relative to the slot 152. As the test sensor 12
continues to move toward the slot 152, the test sensors 12 keeps
turning until it turns about 90 degrees and can pass through the
slot 152 of the test sensor containing region 16.
[0049] FIGS. 12A-12C illustrate the process of dispensing one test
sensor 12 from among the plurality of test sensors 12 stored in a
housing segment 14a or 14b. In one exemplary method, knife assembly
160 is positioned above foil cover 124 over one of the test sensor
containing regions 16. Then, knife assembly 160 is moved in the
direction indicated by arrow A to puncture foil cover 124 with
blade 166. As depicted in FIG. 12B, blade 166 of knife assembly 160
engages the ejection rod 162 after the blade 166 has pierced foil
cover 124. As shown in FIG. 12C, knife assembly 160 is then moved
in the direction indicated by arrow B (i.e., a radially outward
direction) to eject test sensor 12 out of the test sensor
containing region 16. As knife assembly 160 moves, blade 166 cuts
the portion of the foil cover 124 sealing the top portion 116 of
test sensor packaging assembly 110, especially the portion of the
foil cover 124 sealing the test sensor containing region 16
containing the test sensor 12 being ejected. The movement of knife
assembly 160 also urges test sensor 12 toward the outer periphery
114 of test sensor packaging assembly 110. The guide member 154
and/or the test sensor 12 eventually contacts and pierces the
portion of the foil cover 124 covering the outer periphery 114 of
the test sensor packaging assembly 110. Before puncturing the
portion of the foil cover 124 sealing the outer periphery 114 of
the test sensor packaging assembly 110, at least a leading portion
of guide member 154 passes through slot 152 of the test sensor
containing region 16. As test sensor 12 moves radially outward,
guide member 154 engages slot 152 of test sensor containing region
16, causing the test sensor 12 to turn about 90 degrees. At the end
of the ejection process, test sensor 12 is oriented substantially
parallel to the top and/or bottom portions 116, 118 of the test
sensor packaging assembly 110, as shown in FIG. 12C. At this point,
any suitable fluid sample may be applied to the ejected test sensor
12. Test sensor 12 then determines, for example, the glucose
concentration level on such fluid sample. Specifically, the reagent
contained in the test sensor 12 produces a measurable reaction with
an analyte (e.g., glucose) indicative of the presence and/or
concentration of such analyte in the fluid sample. Any suitable
analyte measuring device then displays the analyte reading to the
user. Alternatively, the test sensor 12 may be removed for use with
a separate meter.
[0050] In the exemplary process depicted in FIGS. 12A-12C, blade
166 of knife assembly 160 only cuts the portion of foil cover 124
sealing only one test sensor containing region 16 during the
ejection. Other portions of foil cover 124 remain intact and
continue to seal the other test sensor containing regions 16.
Accordingly, the ejection of a single test sensor 12 does not break
the seal over the other test sensors 12. On the contrary, during
the ejection process, only one test sensor containing region 16 is
opened, while the other test sensor containing region 16 remains
sealed. Thus, while a test sensor 12 is being ejected, the foil
cover 124 seals and protects the remaining test sensors 12.
Consequently, there is no need to open and close the test sensor
containing regions 16 multiple times.
[0051] The user must use a different test sensor 12 for every test.
Once all or some of the test sensors 12 stored in the test sensor
packaging assembly 110 have been used, the user may replenish the
analyte measuring system by replacing only one of the housing
segments 14a, 14b. The user can also replace all the housing
segments 14a, 14b. Though the preferred embodiment of the test
sensor packaging assembly 110 includes two housing segments 14a,
14b, the test sensor packaging assembly 110 may include many more
segments, up to a practical limit. For example, test sensor
packaging assembly 110 may include five (5) housing segments.
[0052] The following numbered paragraphs describe features in
accordance with some embodiments of the disclosure:
[0053] A packaging container for holding a plurality of test
sensors, comprising:
[0054] a first semi-circular housing having a plurality of first
test sensor containing regions, each of the plurality of the first
test sensor containing regions being adapted to contain at least
one test sensor; and
[0055] a second semi-circular housing having a plurality of second
test sensor containing regions, each of the plurality of the second
test sensor containing regions being adapted to contain at least
one test sensor,
[0056] the second semi-circular housing having a top portion, the
first semi-circular housing and the second semi-circular housing
being positioned adjacent to each other,
[0057] wherein said first semi-circular housing further comprises
an outer wall extending in a non-perpendicular manner from said top
portion.
[0058] The packaging container of paragraph [0053], wherein each of
the plurality of first test sensor containing regions further
comprises an opening, and wherein the at least one test sensor in
each of the plurality is capable of being ejected through the
opening.
[0059] The packaging container of paragraph [0054], wherein the
plurality of first test sensor containing regions further comprises
a foil cover and a cutting assembly for removing the foil cover,
the cutting assembly capable of removing the foil cover each time
one of the first test sensors is to be ejected through the opening
of the respective test sensor containing region.
[0060] The packaging container of paragraph [0055], wherein a rod
engages the cutting assembly, the cutting assembly further
comprising a base and a cutting edge extending from the base,
wherein movement of the base causes movement of the cutting edge
and rod.
[0061] The packaging container of paragraph [0056], wherein the
test sensor further comprises a slot constructed and arranged to
receive the rod and wherein movement of the cutting assembly causes
movement of the test sensor.
[0062] The packaging container of paragraph [0053], wherein the
plurality of test sensor containing regions has a top portion
covered by a foil, and wherein each time a test sensor is ejected
from the test sensor containing region, at least a portion of the
foil covering the individual test sensor containing region from
which the test sensor is ejected is cut and the foil covering the
remaining individual test sensor containing regions is not cut.
[0063] The packaging container of paragraph [0053], wherein said
first semi-circular housing may be removed from said packaging
container and replaced with a third semi-circular housing having a
plurality of third test sensor containing regions, each of the
plurality of the third test sensor containing regions being adapted
to contain at least one test sensor.
[0064] The packaging container of paragraph [0054], wherein the
first semi-circular housing may be replaced with the third
semi-circular housing while the second semi-circular housing is
still in place.
[0065] The packaging container of paragraph [0053], wherein
breaking the foil cover only opens individual test sensor
containing regions of the plurality of the test sensor containing
regions.
[0066] The packaging container of paragraph [0053], wherein said
first semi-circular housing and said second semicircular housing
combine to form a circular cartridge.
[0067] A packaging container for holding a plurality of test
sensors, comprising:
[0068] a first semi-circular housing having a plurality of first
test sensor containing regions, each of the plurality of the first
test sensor containing regions being adapted to contain at least
one test sensor; and
[0069] a second semi-circular housing having a plurality of second
test sensor containing regions, each of the plurality of the second
test sensor containing regions being adapted to contain at least
one test sensor,
[0070] the second semi-circular housing having a top portion, the
first semi-circular housing and the second semi-circular housing
being positioned adjacent to each other, and
[0071] wherein each of the test sensor containing regions is
contiguous to a first and a second test sensor containing region on
first and second sides of the test sensor containing region along
the length of test sensor containing region.
[0072] The packaging container of paragraph [0063], wherein said
first semi-circular housing further comprises an outer wall
extending in a non-perpendicular direction away from said top
portion.
[0073] The packaging container of paragraph [0063], wherein each of
the plurality of first test sensor containing regions further
comprises an opening, and wherein the at least one test sensor in
each of the plurality is capable of being ejected through the
opening.
[0074] The packaging container of paragraph [0065], wherein the
plurality of first test sensor containing regions further comprises
a foil cover and a cutting assembly for removing the foil cover,
the cutting assembly capable of removing the foil cover each time
one of the first test sensors is to be ejected through the opening
of the respective test sensor containing region.
[0075] The packaging container of paragraph [0066], wherein a rod
engages the cutting assembly, the cutting assembly further
comprising a base and a cutting edge extending from the base,
wherein movement of the base causes movement of the cutting edge
and rod.
[0076] The packaging container of paragraph [0067], wherein the
test sensor further comprises a slot constructed and arranged to
receive the rod and wherein movement of the cutting assembly causes
movement of the test sensor.
[0077] The packaging container of paragraph [0063], wherein the
plurality of test sensor containing regions has a top portion
covered by a foil, and wherein each time a test sensor is ejected
from the test sensor containing region, at least a portion of the
foil covering the individual test sensor containing region from
which the test sensor is ejected is cut and the foil covering the
remaining individual test sensor containing regions is not cut.
[0078] The packaging container of paragraph [0063], wherein said
first semi-circular housing may be removed from said packaging
container and replaced with a third semi-circular housing having a
plurality of third test sensor containing regions, each of the
plurality of the third test sensor containing regions being adapted
to contain at least one test sensor.
[0079] The packaging container of paragraph [0070], wherein the
first semi-circular housing may be replaced with the third
semi-circular housing while the second semi-circular housing is
still in place.
[0080] The packaging container of paragraph [0063], wherein said
first semi-circular housing and said second semicircular housing
combine to form a circular cartridge.
[0081] It will be appreciated that various features set forth in
the embodiments discussed herein can be combined in different ways
then presented herein. It will also be appreciated that the
features described in connection with individual embodiments may be
shared with other embodiments discussed herein.
[0082] Although the invention herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
invention as detailed by the following claims.
* * * * *