U.S. patent application number 11/106728 was filed with the patent office on 2005-10-27 for blood glucose meter having integral lancet device and test strip storage vial for single handed use and methods for using same.
This patent application is currently assigned to Becton, Dickinson and Company, Becton, Dickinson and Company. Invention is credited to Ahlgrim, Dirk, Chan, Victor, Colucci, Jose JR., Draudt, Gregg R., Follman, Mark, McCaffrey, Robert J., Schminke, Jan, Yao, Raymond.
Application Number | 20050240119 11/106728 |
Document ID | / |
Family ID | 35197469 |
Filed Date | 2005-10-27 |
United States Patent
Application |
20050240119 |
Kind Code |
A1 |
Draudt, Gregg R. ; et
al. |
October 27, 2005 |
Blood glucose meter having integral lancet device and test strip
storage vial for single handed use and methods for using same
Abstract
A blood glucose meter having a test strip port and an adjustable
lancet device disposed at the same end of the device body is
disclosed. The device body further includes an enclosure at the
proximal end of the device body which houses a test strip storage
vial and which facilitates one-handed opening and closing of the
vial to simplify access to test strips contained therein. The
enclosure is further provided with a window which allows the
reading of the lot numbers on the label of the test strip vial
therein without necessitating removal of the vial. A data connector
is also provided on the device body for communication access, such
as to upload data from other devices or to download data to other
devices. By combining these multiple components into a single
device body, the blood glucose meter requires fewer steps for
sampling and testing, and makes device use easier and more
convenient.
Inventors: |
Draudt, Gregg R.; (Slow,
MA) ; Ahlgrim, Dirk; (Boston, MA) ; Schminke,
Jan; (Munchen, DE) ; Follman, Mark; (Glen
Rock, NJ) ; Colucci, Jose JR.; (Lexington, MA)
; Yao, Raymond; (Saint Joseph, MI) ; McCaffrey,
Robert J.; (Hillsboro, NH) ; Chan, Victor;
(Landing, NJ) |
Correspondence
Address: |
John E. Holmes
Roylance, Abrams, Berdo & Goodman, L.L.P.
Suite 600
1300 19th Street, N.W.
Washington
DC
20036
US
|
Assignee: |
Becton, Dickinson and
Company
|
Family ID: |
35197469 |
Appl. No.: |
11/106728 |
Filed: |
April 15, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60562536 |
Apr 16, 2004 |
|
|
|
Current U.S.
Class: |
600/583 ;
435/15 |
Current CPC
Class: |
A61B 2562/0295 20130101;
A61B 5/15113 20130101; A61B 5/14532 20130101; A61B 5/157 20130101;
A61B 5/150259 20130101; A61B 5/15186 20130101; A61B 5/150358
20130101; A61B 5/1519 20130101; A61B 5/150022 20130101; G01N 33/526
20130101; A61B 5/15087 20130101; G01N 33/66 20130101; G01N 33/523
20130101; A61B 5/15115 20130101; A61B 5/150175 20130101 |
Class at
Publication: |
600/583 ;
435/015 |
International
Class: |
A61B 005/00; C12Q
001/48 |
Claims
What is claimed is:
1. A blood glucose meter device for single handed use, comprising:
a body having first and second ends; a lancet device disposed at
said first end of said body; a test strip port disposed at said
first end of said body for positioning a test strip adjacent to
said lancet device; and an enclosure for housing a test strip vial
disposed at said second end of said body.
2. A blood glucose meter device as claimed in claim 1, wherein said
body further comprises a test strip lead-in area extending between
said test strip port and said lancet device.
3. A blood glucose meter as claimed in claim 1, wherein said
enclosure for housing said test strip vial comprises an opening at
said second end of said body for receiving said test strip
vial.
4. A blood glucose meter as claimed in claim 3, wherein said
enclosure for housing said test strip vial further comprises a
window for allowing visual access to said test strip vial contained
therein.
5. A blood glucose meter as claimed in claim 3, wherein said
enclosure for housing said test strip vial further comprises at
least one of a frictional-type retention feature or a positive
mechanical lock to secure said test strip vial.
6. A blood glucose meter device as claimed in claim 1, wherein said
body further comprises: a display; and at least one operator
control for data entry and review through said display.
7. A blood glucose meter device as claimed in claim 1, further
comprising a data connector disposed on said body for communication
access.
8. A blood glucose meter as claimed in claim 7, wherein said
communication access comprises at least one of a data upload
operation and a data download operation.
9. A blood glucose meter device as claimed in claim 1, wherein said
lancet device comprises: a trigger button disposed on said body for
activating said lancet device; an arming slide disposed on said
body for arming said lancet device; and a cylindrical depth control
mechanism for setting a lancet skin penetration depth and for
engaging a skin surface.
10. A blood glucose meter device as claimed in claim 9, wherein
said lancet device further comprises a surface for supporting a
skin surface when rolled toward said adjacent test strip.
11. A blood glucose meter device as claimed in claim 1, wherein
said body further comprises a detachable cover at said first end of
said body for providing access to said lancet device for loading
and unloading of lancets.
12. A method of facilitating one-handed use of a blood glucose
meter device, comprising: providing a test strip port adjacent to a
lancet mechanism; transferring a test strip from a test strip vial
contained in said device to said test strip port such that said
test strip is located adjacent to said lancet mechanism; activating
said lancet mechanism against a skin surface to provide a blood
drop; and transferring said blood drop from said skin surface to
said adjacent test strip.
13. A method as claimed in claim 12, wherein the step of
transferring said blood drop to said adjacent test strip comprises:
resting said skin surface upon said lancet mechanism; and rolling
said skin surface toward said test strip in a substantially
continuous motion to move said blood drop to said adjacent test
strip.
14. A method as claimed in claim 12, wherein the steps of
activating said lancet mechanism against a skin surface to provide
a blood drop and transferring said blood drop to said adjacent test
strip comprises: rotating said skin surface over said lancet
mechanism and toward said adjacent test strip in a substantially
continuous motion to move said blood drop to said adjacent test
strip.
15. A method of using a blood glucose meter device with one hand,
comprising: opening a test strip vial in a first end of a blood
glucose meter device and removing a test strip; positioning said
test strip in a test strip port at a second end of said device and
adjacent to a lancet mechanism; engaging said lancet mechanism at
said second end of said device with a skin surface to provide a
blood drop; applying said blood drop from said skin surface onto
said adjacent test strip.
16. A method as claimed in claim 15, wherein the step of engaging
said lancet mechanism with said skin surface comprises: positioning
said skin surface over said lancet mechanism; and withdrawing said
lancet mechanism from said skin surface to allow formation of said
blood drop on said skin surface.
17. A method as claimed in claim 16, wherein the step of applying
said blood drop from said skin surface onto said test strip
comprises: placing a part of said skin surface in close proximity
to said blood drop on said lancet mechanism as a support surface;
and rotating said skin surface toward said adjacent test strip in a
substantially continuous motion to apply said blood drop from said
skin surface onto said adjacent test strip.
18. A method as claimed in claim 16, wherein the steps of engaging
said lancet mechanism at said second end of said device with a skin
surface to provide a blood drop and applying said blood drop from
the skin surface onto said adjacent test strip comprise: rotating
said skin surface over said lancet mechanism and toward said
adjacent test strip in a substantially continuous motion to apply
said blood drop from said skin surface onto said adjacent test
strip.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C.
.sctn.119(e) from a U.S. Provisional Patent Application of Gregg
Draudt et al., entitled "Blood Glucose Meter Having Integral Lancet
And Vial Storage For Single Handed Use And Method For Using Same",
Ser. No. 60/562,536, filed on Apr. 16, 2004, the entire content of
which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a blood glucose meter with
an integral lancet device, and a location on the device to store
test strip vials, such that one-handed use for lancet device, meter
and test strip access functions are possible.
BACKGROUND OF THE INVENTION
[0003] As the number of patients suffering from diabetes and
similar medical conditions increases, self-monitoring of blood
glucose wherein the patient monitors his or her blood glucose
levels has become a common practice. Various mechanisms have been
created to achieve these results, and typically include a lancet
device and a blood glucose meter.
[0004] Blood glucose meters often further include a memory for
storing measured blood glucose values, exercises and meals, along
with other related data such as the corresponding dates, time of
day, and duration of each, and the units that were used as these
values and events were measured. Blood glucose meters are also
generally provided with a display screen and user input buttons or
controls with which a user can specify which of the stored values
to display or functions to access.
[0005] A blood glucose meter can be configured to receive and read
an inserted test strip on which a drop of a patient's blood has
been deposited. Still other devices include an integrated lancet
device and glucose meter for ease of self-monitoring. Such systems
are disclosed, for example, in U.S. Pat. No. 4,787,398, to Garcia
et al., entitled "Glucose Medical Monitoring System", the entire
content of which is incorporated herein by reference.
[0006] In many devices, the lancet mechanism and the detection
mechanism are separate. In doing so, the lancet device including
the lancet, and the detection unit including the test strip, which
are provided separately or are separately mounted on a monitoring
system, result in a very complicated operation for the user.
[0007] Accordingly, a need exists for a device and method to
provide a blood glucose meter with an integral lancet device, and a
location on the device to store test strip vials, such that
one-handed use for lancet device, meter and test strip access
functions are possible.
SUMMARY OF THE INVENTION
[0008] It is therefore an object of the present invention to
provide a blood glucose meter with an integral lancet device, and a
location on the device to store a test strip vial, such that
one-handed use for lancet device, meter and test strip access
functions are possible.
[0009] It is another object of the present invention to provide a
blood glucose meter with an integral lancet device such that
lancing and testing processes are positioned sufficiently close in
proximity to allow a virtually continuous short motion by the user
to achieve the functions of each.
[0010] It is another object of the present invention to provide a
blood glucose meter with a location on the device to store test
strip vials, such that vial access can be achieved using a
one-handed motion.
[0011] It is another object of the present invention to provide a
blood glucose meter with a location on the device to store test
strip vials, such that vial content information is visible to a
user without removal of the vial from the device.
[0012] It is another object of the present invention to provide a
blood glucose meter providing further analytical functions,
including communication with other devices.
[0013] These and other objects are substantially achieved by
providing a blood glucose meter having a test strip port and
adjustable lancet device disposed at the same end of the device
body. The device further includes an enclosure at an opposite end
which houses a test strip vial, and which further facilitates
one-handed opening and closing of the vial to simplify access to
the contained test strips. A data connector or wireless
communication module can be located on the bottom of the enclosure
of the device for communication access, such as to upload data from
other devices and download data to other devices, and a window can
be provided on a device surface which allows the reading of lot
numbers on the label of the test strip vial without requiring the
removal of the vial from the device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The above and other objects and advantages will become more
apparent upon consideration of the following drawings and detailed
description, in which:
[0015] FIG. 1 is a perspective view illustrating the top surface of
a blood glucose meter in accordance with an embodiment of the
present invention;
[0016] FIG. 2 is a perspective view illustrating the bottom surface
of the embodiment of FIG. 1;
[0017] FIGS. 3 through 5 are views illustrating an exemplary manner
of use of an embodiment of the present invention for lancing a
finger to provide a blood drop;
[0018] FIGS. 6 and 7 are views illustrating an exemplary manner of
use of an embodiment of the present invention by rolling a
bottom-lanced finger over a test strip using the stationary device
end as a rest for the lanced finger to provide the blood drop to
the test strip;
[0019] FIGS. 8 and 9 are views illustrating an exemplary manner of
use of an embodiment of the present invention by moving a
side-lanced finger a short distance to the test strip to provide
the blood drop to the test strip;
[0020] FIGS. 10 through 12 are views illustrating an exemplary
manner of use of an embodiment of the present invention by rolling
the finger over a stationary device to provide the blood drop to
the test strip; and
[0021] FIGS. 13 through 16 are views illustrating an exemplary
manner of use of an embodiment of the present invention for using a
single hand to open and close a test strip vial to access a test
strip.
[0022] Throughout the drawing figures, it will be understood that
like numerals refer to like structures.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0023] The exemplary embodiments of the present invention described
below relate to a blood glucose meter with an integral lancet
device, and a location on the device to store a test strip vial
that holds a number of test strips. The disclosed embodiments of
the present invention combine the functionality of each above
feature into a streamlined enclosure that optimizes the use of the
product for the purpose of monitoring one's blood glucose.
[0024] FIG. 1 is a perspective view illustrating the top surface of
a blood glucose meter in accordance with an embodiment of the
present invention. The main features of the disclosed embodiments
of the present invention include a device body 10 configured for
convenient one-handed use, test strip port 20 and lancet device 30
that are disposed at the same end of the device body 10, thereby
allowing a drop of blood extracted by the lancet device 30 to be
immediately deposited on the test strip (not shown) in the test
strip port 20, a detachable cover 40 which allows lancet
replacement and also provides a generous lead-in area 45 to
facilitate convenient test strip loading into the test strip port
20, a trigger button 50 on the side of the device body 10 which
allows comfortable positioning during lancing, an arming slide 60
on the sides and bottom of the enclosure of the device body 10
which arms the lancing mechanism of the lancet device 30 when moved
toward the back of the device, wherein the location of the arming
slide 60 keeps the outer size of device body 10 as small as
possible, and an enclosure 70 which houses a test strip vial 75
containing multiple test strips and which allows one-handed vial
opening. The device body 10 further includes a blood glucose meter
80 for processing the test strip, and a data connector 90 (see FIG.
2) located on the bottom of enclosure for data exchanges with an
electronic pen-type injector or other device. The blood glucose
meter 80 can further include a display window 82 and a plurality of
meter operation buttons or controls 84. The enclosure 70 can
further include a window 72 which allows reading of a test strip
lot number on a test strip vial 75 label therein without removing
the strip vial from the device body 10. By combining these multiple
components into a single device body 10, the device requires fewer
steps for testing, and makes device use easier, even in confined or
less than ideal locations to test one's blood glucose levels.
[0025] As noted above, many existing devices require the use of a
separate blood glucose meter, lancet device and test strip storage
vial. These existing devices can, therefore, require an extensive
amount of handling and manipulation of separate devices to
facilitate the measurement of one's blood glucose, which is an
undesirable outcome. The exemplary embodiments of the present
invention combine these separate device features into a single
device by combining a blood glucose meter, lancet device and test
strip storage, thereby requiring much less handling and
manipulation to accomplish a desirable outcome.
[0026] The embodiment of the present invention shown in FIG. 1
takes advantage of the small size of the primary sub-components,
including blood glucose sensing circuitry/technology of the blood
glucose meter 80, lancet mechanism of the lancet device 30, and
test strip storage vial 75, and encapsulates each in an attractive
and user-friendly package. The combination of these sub-systems as
shown in the embodiment of FIG. 1 results in a reduction in the
number of steps required to test one's blood glucose as described
in greater detail below. The blood glucose sensing
circuitry/technology of the blood glucose meter 80, lancet
mechanism of the lancet device 30, and test strip storage vial 75
are well known to those skilled in the art and a detailed
description of each is omitted for clarity and conciseness.
[0027] FIGS. 1 and 2 illustrate a first embodiment of the present
invention. FIG. 1 is a perspective view illustrating the top
surface of the device, and FIG. 2 is a perspective view
illustrating the bottom surface of the device.
[0028] The device of FIG. 1 includes a device body 10 which is
configured for convenient one-handed use. The device body 10
comprises a tapered cylindrical housing having flattened top and
bottom surfaces. The device body 10 can be any suitable length, but
preferably comprises a length of about 160 mm. The top and bottom
surfaces of the device body 10 preferably have a width of about 25
mm. The device body 10 can be constructed of any suitable material,
but is preferably constructed of an engineering plastic
material.
[0029] At a distal end of the device of FIG. 1, a test strip port
20 and adjustable lancet device 30 are disposed at the same end of
the device body 10. In doing so, a test strip (not shown) can be
provided very close to the lancet device 30. A generous lead-in
area 45 to the test strip port 20 is provided for improved
usability, and can comprise a color highlighted area surrounding
the opening of the test strip port 20 to provide improved
visibility. The lead-in area 45 can be provided for holding the
test strip during use, and can be constructed as a notch at the
distal end of the device body 10 extending from an open end 46 at
the distal end of the device to the test strip port 20, and having
a slightly wider opening at the open end 46 of about 7.0 mm, which
narrows to equal the opening of the test strip port 20. The lead-in
area 45 can be provided having any suitable length, but is
preferably about 18 mm long. The test strip port 20 can be provided
to be within 27.6 mm of the distal end of the lancet device 30.
Accordingly, a test strip when positioned in the lead-in area 45
can be provided to be within 3.8 mm of the distal end of the lancet
device 30.
[0030] A detachable cover 40 is provided and allows convenient
lancet replacement when desired. Contours and/or recesses in the
detachable cover 40 can provide the lead-in area 45 to guide the
test strip into the test strip port 20. The detachable cover 40 can
be constructed of any suitable material, but is preferably
constructed of the same material as the device body 10. The
detachable cover 40 can be secured to the device body 10 using any
number of attachment mechanisms, such as a snap-fit mechanism. Grip
features 47 comprising a number of raised ribs are provided on the
sides of the detachable cover 40 to aid in the removal and
replacement of the cover 40 from and to the device body 10.
[0031] A trigger button 50 is disposed on one or both sides of the
device body 10, allowing comfortable positioning during lancing
when using either a right or left hand. The trigger button 50 is
mechanically engaged with the lancet mechanism of the lancet device
30 through the device body 10 to activate the lancet as known to
those skilled in the art when a force is exerted on the trigger
button 50, such as when pressed by a user. An arming slide 60 is
disposed on the sides and bottom of the device body 10 to minimize
the overall envelope of the device. The arming slide 60 is also
mechanically engaged with the lancet mechanism of the lancet device
30 through the device body 10 to arm the lancet as known to those
skilled in the art through a sliding motion of the arming slide 60,
such as when slid by a user. Accordingly, the arming slide 60 can
be disposed within a recess 65 extending over the sides and bottom
of the device body 10. The arming slide 60 can be guided in the
recess 65 using any number of mechanisms, such as rails (not shown)
disposed along each side of the recess 65 and engaged by the arming
slide 60. By further providing the arming slide 60 with a number of
raised members 62, a user can firmly grasp the arming slide 60 with
one hand and arm the lancet by pressing the proximal end of the
device body 10 against a surface to move the arming slide 60 within
the recess 65.
[0032] The device further includes an enclosure 70 in the proximal
end of the device body 10 which houses a test strip vial 75, and
which facilitates one-handed opening and closing of the test strip
vial 75 to simplify access to test strips contained therein. The
enclosure 70 can be an axial opening in the device body 10, having
a sufficient diameter and which extends to a sufficient depth to
receive a test strip vial 75. In an exemplary embodiment of the
present invention, the enclosure 70 can have an opening of 18 mm
and a depth of 35.4 mm. The enclosure 70 can further comprise a
retention feature for the test strip vial 75, such as a
friction-type retention feature or a positive mechanical lock, for
engaging and retaining the test strip vial 75 therein. The extended
cap or lid 78 of the test strip vial 75 remains exposed and
extending from the proximal end of the device body 10, which allows
one-handed opening of the test strip vial 75 as described in
greater detail below.
[0033] The enclosure 70 further comprises a window 72 which allows
the reading of the lot numbers on the label of the test strip vial
75 therein without necessitating the removal of the test strip vial
75 from the enclosure 70. The window 72 can be constructed of any
suitable clear material, and can be further provided with a lens to
enlarge the text of the test strip vial 75 label.
[0034] The device body 10 further includes a lancet device 30 for
lancing a skin surface and providing a blood sample to a test strip
(not shown) held in the lead-in area 45. The tip of the lancet
device 30 comprises a substantially cylindrical depth control
mechanism 32 against which the user engages a skin surface.
Accordingly, the lancet device 30 can be adjustable. In the
embodiments of the present invention, the depth setting is selected
by rotating the cylindrical depth control mechanism 32 to the
desired setting number positioned adjacent to the depth selection
indicator 48. Further, the lancet device 30 can be armed and
activated as described above, and can include a lancet (not shown)
that can be easily accessed via the detachable cover 40.
[0035] The device body 10 further includes a blood glucose meter 80
for processing the test strip (not shown) received via the test
strip port 20. The blood glucose meter 80 can further include a
display window 82, such as an LCD display or like device, which can
display any number of test results. A plurality of blood glucose
meter operation buttons or controls 84 can be provided to allow a
user to control the meter 80 and meter display window 82. A data
connector 90 can be provided with the blood glucose meter 80 for
communication access, such as to upload data from other devices or
to download data from the device to other devices. The data
connector 90 can be disposed on the bottom of device body 10 for
data exchanges with an electronic pen-type injector or other
devices, and can comprise any number of hardwired or wireless
communication connectors. Preferably, the data connector 90
comprises a multiple contact electrical connector, such as a three
contact electrical connector.
[0036] The use of the disclosed embodiments of the present
invention, described in greater detail below, significantly
benefits from the combined features described above and shown in
FIGS. 1 and 2. As noted above, the embodiments of the present
invention include a blood glucose meter 80 with an integral lancet
device 30, and a location 70 on the device body 10 to store a test
strip vial 75 that holds a number of test strips (i.e., up to 25 or
more). The embodiments further include the test strip port 20 for
the glucose test strip, and the tip of the lancet of the integral
lancet device 30, at the same end of the device body 10. In doing
so, the embodiments of the present invention allow a user to insert
a test strip into the lead-in area 45, arm the lancet device 30,
lance a finger, and collect the blood on the edge of the test strip
held in the lead-in area 45 with minimal wasted movement and time
(i.e., a virtually continuous short motion). Such steps are
outlined and illustrated in FIGS. 3 through 12.
[0037] Many existing devices provide the lancet device at the
opposite end from the test strip, requiring the user to perform an
awkward maneuver to rotate the unit after lancing. Still other
existing devices require either the use of a separate lancet device
in the case of meter-only units, or a rotation of the meter in the
case of meters with lancet device and test strip port at opposite
ends. The embodiments of the present invention solve these problems
by placing the test strip port 20 and the lancet of the lancet
device 30 in as close proximity as is ergonomically possible at the
distal end of the device body 10, thereby minimizing wasted
motion.
[0038] In the disclosed embodiments of the present invention, the
geometry of the distal end or tip of the device, which includes the
test strip port 20 and the lancet device 30 positioned close
together, results from the use of a compact mechanism for the
lancet device 30, and a compact integrated printed circuit board
for the glucose meter 80 electronics. The device further provides
the detachable cover 40 at the distal end, which provides a
generous sized lead-in area 45 to guide the test strip into the
test strip port 20. As noted above, the lead-in area 45 can further
include a color highlighted area (not shown) surrounding the
opening of the test strip port 20 for improved visibility and
ergonomics.
[0039] In the use of the embodiments of the present invention as
illustrated in FIGS. 3 through 5, a tester can lance any number of
positions on a skin surface, such as a bottom surface of a finger
or a side surface of a finger. Specifically, FIG. 3 illustrates a
lancing technique on a bottom surface of a finger, FIG. 4
illustrates a close-up view of the lancing technique of FIG. 3, and
FIG. 5 is a view of a lancing technique on a side surface of a
finger. Further, as illustrated in FIGS. 6 and 7, many testers
after lancing a skin surface will prefer to use the tip of the
device to support the lanced finger and gently roll it over the
device tip to apply the blood drop onto the test strip held in the
lead-in area 45. Specifically, FIG. 6 illustrates a bottom-lanced
finger resting on the device tip, and FIG. 7 illustrates the
bottom-lanced finger of FIG. 6 being rolled toward the test strip
to apply the blood drop onto the test strip while resting on the
device tip. However, as illustrated in FIGS. 8 and 9, many testers
after lancing a skin surface may not desire to use the tip of the
device to support the lanced finger, but prefer to simply move the
lanced skin surface from the device tip to apply the blood drop
onto the adjacent test strip held in the lead-in area 45.
Specifically, FIG. 8 illustrates a side-lanced finger moved the
short distance from the device tip to the test strip, and FIG. 9
illustrates the side-lanced finger of FIG. 8 being used to apply
the blood drop onto the test strip.
[0040] Still other testers may prefer to hold the device stationary
and rotate the skin surface across the tip of the lancet device and
to the adjacent test strip in a substantially continuous motion. As
described below, such a "strip-to-tip rotate" method of use is
shown in FIGS. 10 through 12. Still other testers after lancing a
skin surface, may prefer to use a second or adjacent finger to
support the lanced finger to gently roll it over and toward the
test strip to apply the blood drop onto the test strip held in the
lead-in area 45.
[0041] FIGS. 3 through 5 are views illustrating an exemplary manner
of use of an embodiment of the present invention for lancing a
finger after arming the device. As noted above, the user can first
arm the lancet device 30 by firmly grasping the arming slide 60
with one hand and pressing the proximal end of the device body 10
against a surface to move the arming slide 60 within the recess
65.
[0042] In FIGS. 3 through 5, a test strip 76 is positioned in the
lead-in area 45 at the distal end of the device body 10 and
adjacent to the lancet device 30 as a user engages the lancet
device 30 with a skin surface 95. In doing so, a bottom surface of
a finger can be lanced as shown in FIGS. 3 and 4, or a side surface
of a finger can be lanced as shown in FIG. 5. The user can then
apply the blood drop from the skin surface 95 to the test strip 76
in a number of motions, each requiring a minimal travel distance
and device manipulations. Specifically, the user can use the device
tip to rest the lanced finger and provide a guide while rolling the
blood drop to the adjacent test strip 76, the user can use a second
finger to rest the lanced finger and provide a guide while rolling
the blood drop to the adjacent test strip 76, the user can rotate
the lanced finger about the stationary device to provide the blood
drop to the adjacent test strip 76, or the user can simply move the
lanced finger a short distance to provide the blood drop to the
adjacent test strip 76.
[0043] In FIGS. 6 and 7, the user is shown applying the blood drop
from the skin surface 95 onto the test strip 76 that is positioned
in the lead-in area 45. Specifically, the user engages the lancet
device 30 with a skin surface 95 (in this case, the bottom surface
of the finger) by rolling the skin surface 95 over the tip of the
lancet device 30. The tip of the lancet device 30 includes a
substantially cylindrical depth control mechanism 32 against which
the user engages the skin surface 95. Once lanced, the lancet
device 30 is withdrawn slightly from the skin surface 95 to allow
the formation of a blood drop on the skin surface 95. The user can
then place a different part of the finger (in this case, the side
surface of the finger) on the top of the tip of the lancet device
30 as a rest/support surface. In such a rested/supported position,
the user can then rotate the lanced finger toward the test strip 76
to apply the blood drop from the skin surface 95 onto the test
strip 76 as shown in FIGS. 6 and 7 with less effort, yet with a
greater degree of control and precision. The embodiments of the
present invention still further allow the user to use a second or
adjacent finger as a rest or support when rotating the lanced
finger to apply the blood drop onto the test strip 76.
[0044] Where a rest or support is not required or desired by the
user, the user can simply move the finger the short distance
between lancet device 30 and the adjacent test strip 76 to apply
the blood drop onto the test strip 76 as shown in FIGS. 8 and 9.
FIGS. 8 and 9 are views illustrating an exemplary manner of use of
an embodiment of the present invention by moving a side-lanced
finger a short distance to the test strip to provide the blood drop
to the test strip.
[0045] In the above manners of use, the user can either rotate the
finger against the lancet device 30 and toward the test strip 76 in
a substantially continuous motion, or move the finger to apply the
blood drop onto the test strip 76. For example, the embodiments of
the present invention provide for a manner of use in which the
finger is rotated against a stationary, or substantially stationary
device. FIGS. 10 through 12 are views illustrating an exemplary
manner of use of an embodiment of the present invention by rolling
the finger over a stationary device and toward a test strip in a
substantially continuous motion to provide the blood drop to the
test strip. Specifically, in such a "strip-to-tip rotate" method,
the user engages the lancet device 30 with a skin surface 95 by
rolling the skin surface 95 over the tip of the lancet device 30 to
produce a blood drop as shown in FIG. 10. Once lanced, the lancet
device 30 is withdrawn slightly from the skin surface 95 to allow
the formation of the blood drop. The user can then rotate the
finger to bring the blood drop toward the adjacent test strip 76 to
apply the blood drop onto the test strip 76 as shown in FIGS. 11
and 12 with less effort, yet with a greater degree of control and
precision. In this manner of use, the finger is rotated about the
stationary device.
[0046] Another feature of the embodiments of the present invention
described above is the one-handed use of the embodiments to access
the test strip vial 75 located in the enclosure 70 at the proximal
end of the device body 10. In FIGS. 13 through 16, a user is shown
opening and closing the test strip vial 75 with one hand. FIGS. 13
through 16 are views illustrating an exemplary manner of use of an
embodiment of the present invention for using a single hand to
access a test strip vial.
[0047] Accordingly, the embodiments of the present invention can
include a blood glucose meter 80 with an integral lancet device 30,
and an enclosure 70 provided on the device body 10 to store a test
strip vial 75 that holds a number of test strips. As noted in FIGS.
1 and 2, the embodiments house the glucose test strip vial 75 in a
compartment or enclosure 70 that is located at the proximal end of
the device. In doing so, all of the supplies that are typically
required for a test are located in the body of the device.
[0048] Most existing blood glucose meters have a separate test
strip vial, and at least one existing device has the test strips
mounted on a carousel for dispensing. The embodiments of the
present invention described above, however, combine a blood glucose
meter 80, lancet device 30, and test strip storage 70, into one
device. These embodiments can include any number of variations,
however, each combining a lancet device 30 and blood glucose meter
80, with provisions to store a test strip vial 75.
[0049] The embodiments of the present invention can provide any
number of types of inboard, or on-device storage for a strip vial
75 in a meter-lancet device combination, and include any number of
types of retention features for the test strip vial 75, such as a
friction-type retention feature, a positive mechanical lock, or
other similar mechanism for engaging and retaining the test strip
vial 75 in the enclosure 70. However, in each embodiment and
versions thereof, the test strip vial 75 and enclosure 70 are
preferably constructed so that the test strip vial 75 can be
operated with one hand as shown in FIGS. 13 through 16.
[0050] FIGS. 13 through 16 illustrate a one-handed use of an
embodiment of the present invention, including a test strip vial 75
and an enclosure 70 with a combined lancet device 30 and blood
glucose meter 80. In FIG. 13, a user holds the device body 10 in
one hand and positions a finger at the proximal end of the device
body 10. Using the finger of one hand, the user can then open the
test strip vial 75 located in the enclosure 70 at the proximal end
of the device body as shown in FIG. 14 to remove a test strip for
use. The user can still further close the test strip vial 75
located at the proximal end of the device body as shown in FIG. 15.
The opening and closing operations of the test vial 75 can be
further achieved through the use of an extended test vial cap 78 as
shown in greater detail in FIG. 16.
[0051] Although only a few exemplary embodiments of the apparatus
and methods of the present invention have been described in detail
above, those skilled in the art will readily appreciate that many
modifications are possible in the exemplary embodiments without
materially departing from the novel teachings and advantages of the
present invention. Accordingly, all such modifications are intended
to be included within the scope of the present invention as defined
in the appended claims and equivalents thereof.
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