U.S. patent application number 16/875212 was filed with the patent office on 2020-09-03 for diagnostic medical device and methods of use thereof.
The applicant listed for this patent is Insulet Corporation. Invention is credited to John Bussiere, John D. D'arco, David Nazzaro, Jason B. O'connor.
Application Number | 20200278338 16/875212 |
Document ID | / |
Family ID | 1000004828299 |
Filed Date | 2020-09-03 |
United States Patent
Application |
20200278338 |
Kind Code |
A1 |
Nazzaro; David ; et
al. |
September 3, 2020 |
DIAGNOSTIC MEDICAL DEVICE AND METHODS OF USE THEREOF
Abstract
A medical device to test bodily fluid, the device comprising a
light emitting source, the light emitting source arranged to emit
light inside the medical device; a test strip port, the test strip
port comprising a test strip port receptacle to receive a test
strip; and the light emitting source and the test strip port
arranged such that, when the light emitting source emits light, at
least a portion of the light emitted from the light emitting source
is redirected inside the medical device to provide redirected light
inside the medical device, and at least a portion of the redirected
light lights the test strip port from inside the medical device in
a manner than the redirected light is visible outside the test
strip port.
Inventors: |
Nazzaro; David; (Groveland,
MA) ; Bussiere; John; (Littleton, MA) ;
O'connor; Jason B.; (Acton, MA) ; D'arco; John
D.; (Wilmington, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Insulet Corporation |
Acton |
MA |
US |
|
|
Family ID: |
1000004828299 |
Appl. No.: |
16/875212 |
Filed: |
May 15, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15009979 |
Jan 29, 2016 |
10684271 |
|
|
16875212 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 33/49 20130101;
G01N 33/4875 20130101 |
International
Class: |
G01N 33/487 20060101
G01N033/487; G01N 33/49 20060101 G01N033/49 |
Claims
1. A device, comprising: a main body; and a test module detachably
coupled to the main body, the test module including a cover
engageable to the main body by engagement of a snap-fit connection
and disengageable from the main body by disengagement of the
snap-fit connection, wherein the snap-fit connection is engageable
by translational motion of the cover relative to the main body, and
wherein the snap-fit connection is disengageable by rotational
motion of the cover relative to the main body.
2. The device of claim 1, wherein the snap-fit connection is not
disengageable by translational motion of the cover relative to the
main body.
3. The device of claim 1, wherein the main body comprises a center
axis and at least two resilient cantilevered arms, and wherein the
at least two resilient cantilevered arms are arranged to move
towards and away from the center axis.
4. The device of claim 3, wherein the at least two resilient
cantilevered arms are arranged to move towards each other during
engagement of the snap-fit connection.
5. The device of claim 3, wherein the at least two resilient
cantilevered arms each include at least one engagement tab, wherein
the cover includes at least two engagement tab receptacles, and
wherein each of the at least two engagement tab receptacles is
configured to receive one of the engagement tabs.
6. A device, comprising: a main body; and a test module detachably
coupled to the main body, wherein the test module comprises a cover
including a receptacle operable to receive a biasable arm of the
main body for coupling the main body and the cover together, and
wherein the cover includes a rib engageable within a rib receptacle
of the main body to restrict motion of the cover relative to the
main body.
7. The device of claim 6, the cover further comprising an
engagement tab operable to engage a corresponding engagement tab of
the biasable arm to restrict translational motion of the cover away
from the main body.
8. The device of claim 7, the engagement tab of the cover
comprising a sloped surface operable to bias the biasable arm
relative to a center axis of the main body as the engagement tab
and the corresponding engagement tab engage one another.
9. The device of claim 7, the corresponding engagement tab of the
biasable arm comprising a sloped surface operable to bias the
biasable arm relative to a center axis of the main body as the
engagement tab and the corresponding engagement tab engage one
another.
10. The device of claim 9, the main body further comprising a
second biasable arm, wherein the biasable arm and the second
biasable arm are operable to move relative to the center axis of
the main body when the main body and the cover are coupled
together.
11. The device of claim 6, the cover further comprising a test
strip receptacle.
12. The device of claim 6, wherein the rib extends from an inner
surface of the cover.
13. The device of claim 6, the test module further comprising one
or more electronic components and a test strip connector coupled to
the cover, the test strip connector operable to receive a test
strip.
14. A handheld electronic device, comprising: a main body; and a
test module detachably coupled to the main body, wherein the test
module comprises a cover including an engagement tab operable to
engage a biasable arm of the main body for securing the main body
and the cover together, and wherein the cover includes a rib
engageable within a rib receptacle of the main body to restrict
motion of the cover and the main body relative to one another.
15. The handheld electronic device of claim 14, the biasable arm
comprising a corresponding engagement tab, wherein the engagement
tab and the corresponding engagement tab are operable to engage one
another to restrict translational motion of the cover relative to
the main body.
16. The handheld electronic device of claim 15, the corresponding
engagement tab comprising a sloped surface operable to bias the
biasable arm relative to a center axis of the main body as the
engagement tab and the corresponding engagement tab engage one
another.
17. The handheld electronic device of claim 16, the main body
further comprising a second biasable arm, wherein the biasable arm
and the second biasable arm are operable to move relative to the
center axis of the main body when the main body and the cover are
coupled together.
18. The handheld electronic device of claim 14, the cover further
comprising a test strip receptacle.
19. The handheld electronic device of claim 14, the test module
further comprising one or more electronic components coupled to the
cover.
20. The handheld electronic device of claim 14, wherein the rib
extends from an inner surface of the cover.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of pending U.S.
Non-Provisional patent application Ser. No. 15/009,979, filed Jan.
29, 2016, the entire contents of which is incorporated by reference
herein by reference in its entirety.
TECHNICAL FIELD
[0002] The present disclosure relates to handheld electronic
devices, and more particularly to diagnostic (fluid testing)
medical devices.
BACKGROUND INFORMATION
[0003] Medical devices include diagnostic devices to determine a
medical condition of a patient or other person. Diagnostic medical
devices include fluid testing medical devices, which may be used to
test bodily fluids of a person. One such diagnostic medical device
is a blood glucose meter, which is used as a diagnostic device to
determine blood glucose levels of a person having diabetes
mellitus.
[0004] Blood glucose meters use a test strip that receives a blood
sample from a person when placed thereon. The blood glucose meter
includes a test strip port to receive the test strip. The test
strip includes electrical contacts that are electrically coupled to
the meter when the test strip is inserted into the meter. The meter
may then determine a blood glucose level by measuring electrical
current passed through the electrical contacts of the strip, and
provide a determination of the glucose concentration level in the
person's blood with an algorithm.
[0005] As may be appreciated, a person may have to measure their
blood glucose level at various times during a day. As such, the
blood glucose meter typically remains with the person.
Unfortunately, the meter may be stored or otherwise placed in
environments where solid (e.g. dirt) and liquid (e.g. water) debris
may enter the test strip port, which may damage the blood glucose
meter from proper operation.
[0006] It also may be appreciated that a person may have to measure
their blood glucose level at night. As such, if surrounding
artificial light is not present, it may become difficult to
properly place the test strip in the test strip port.
SUMMARY
[0007] The present disclosure provides medical devices,
particularly diagnostic (fluid testing) medical devices which make
use of a test strip to test bodily fluid of a body, particularly
that of a person or animal. More particularly, the diagnostic
medical devices may be blood glucose meters, which are used as
diagnostic devices to a determine blood glucose level of a person
or animal having diabetes mellitus.
[0008] The diagnostic (fluid testing) medical devices disclosed
herein include a test strip port having a test strip port
receptacle to receive the test strip. The test strip port may be
lighted to assist in proper placement of a test strip in the test
strip port at night or otherwise low light conditions. The test
strip port may also be protected from egress of solid particulate
as well as liquid.
[0009] In certain embodiments, a medical device to test bodily
fluid may comprise a light emitting source, the light emitting
source arranged to emit light inside the medical device; a test
strip port, the test strip port having a test strip port receptacle
to receive a test strip; and the light emitting source and the test
strip port arranged such that, when the light emitting source emits
light, at least a portion of the light emitted from the light
emitting source is redirected inside the medical device to provide
redirected light inside the medical device, and at least a portion
of the redirected light lights the test strip port from inside the
medical device in a manner than the redirected light is visible
outside the test strip port.
[0010] In certain embodiments, the test strip port may include a
light guide comprising a light guide annular ring defining a light
guide annular ring opening, the light guide annular ring arranged
such that, when a test strip is received into the test strip port
receptacle, the test strip extends through the light guide annular
ring opening; and the light guide is arranged to receive light
emitted from the light emitting source and redirect at least a
portion of the light from the light emitting source towards the
light guide annular ring to light the light guide annular ring from
inside the medical device. In certain embodiments, the light guide
is translucent or transparent.
[0011] In certain embodiments, the light guide may be formed from a
thermoplastic polymer composition. In certain embodiments, the
thermoplastic polymer composition may include at least one
translucent polymer and/or at least one transparent polymer. In
certain embodiments, the thermoplastic polymer composition may
include at least one of polycarbonate, polyurethane, polystyrene
and polymethyl methacrylate.
[0012] In certain embodiments, the medical device to test bodily
fluid may further comprise an outer cover which is detachable from
the medical device and reattachable to the medical device, and the
test strip port may be fastened to the outer cover. In certain
embodiments, the light guide of the test strip port may be fastened
to the outer cover.
[0013] In certain embodiments, the test strip port may include a
test strip connector, the test strip connector including electrical
contacts which electrically couple with the test strip, and the
light guide may form a pocket with the outer cover which receives a
portion of the test strip connector.
[0014] In certain embodiments, the light emitting source may be
arranged such that, when a test strip is received into the test
strip port receptacle, the light from the light emitting source is
aimed substantially transverse to a longitudinal axis of the test
strip and towards the test strip.
[0015] In certain embodiments, the light guide may be arranged to
redirect at least a portion of the light from the light emitting
source approximately ninety degrees towards the light guide annular
ring such that the redirected light travels substantially parallel
to the longitudinal axis of the test strip.
[0016] In certain embodiments, the test strip port may further
comprise a seal which inhibits ingress of at least one of solid
particulate and water into the test strip port receptacle.
[0017] In certain embodiments, the seal may provide an ingress
protection rating of IP22 when tested in accordance with
International Standard IEC 60529:1989+A1:1999(E) of the
International Electrotechnical Commission.
[0018] In certain embodiments, the seal may include a closure flap
which extends over at least a portion of the test strip port
receptacle.
[0019] In certain embodiments, the test strip port may include a
light guide comprising a light guide annular ring defining a light
guide annular ring opening, the light guide annular ring arranged
such that, when a test strip is received into the test strip port
receptacle, the test strip extends through the light guide annular
ring opening, and the light guide may be arranged to receive light
emitted from the light emitting source and redirect at least a
portion of the light from the light emitting source towards the
light guide annular ring to light the light guide annular ring from
inside the medical device, the seal closure flap may extend over at
least a portion of the light guide annular ring opening to inhibit
the ingress of at least one of the solid particulate and the water
into the test strip port receptacle.
[0020] In certain embodiments, the seal may comprise a seal annular
ring defining a seal annular ring opening, the seal annular ring
arranged such that, when a test strip is received into the test
strip port receptacle, the test strip extends through the seal
annular ring opening.
[0021] In certain embodiments, the seal may be formed from an
elastomeric polymer composition. The elastomeric polymer
composition may include at least one translucent polymer and/or at
least one transparent polymer, and the elastomeric polymer
composition may include at least one elastomer. The at least one
elastomer may be a (silicone) rubber. In certain embodiments, the
seal may be translucent or transparent.
[0022] The present disclosure also provides a handheld electronic
device comprising a main body, a cover engageable to the main body
by engagement of a snap-fit connection and disengageable from the
main body by disengagement of the snap-fit connection, the snap-fit
connection engageable by translational motion of the cover relative
to the main body, and the snap-fit connection disengageable by
rotational motion of the cover relative to the main body, while the
snap-fit connection is not disengageable by translational motion of
the cover relative to the main body.
[0023] In certain embodiments, the main body comprises a center
axis and at least two resilient cantilevered arms, and the at least
two resilient cantilevered arms are arranged to move towards and
away from the center axis.
[0024] In certain embodiments, the at least two resilient
cantilevered arms are arranged to move towards each other during
engagement of the snap-fit connection.
[0025] In certain embodiments, the at least two resilient
cantilevered arms each include at least one engagement tab, the
cover includes at least two engagement tab receptacles, and each of
the at least two engagement tab receptacles is configured to
receive one of the engagement tabs.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The above-mentioned and other features of this disclosure,
and the manner of attaining them, will become more apparent and
better understood by reference to the following description of
embodiments described herein taken in conjunction with the
accompanying drawings, wherein:
[0027] FIG. 1 is a front (plan) view of a medical device according
to the present disclosure;
[0028] FIG. 2 is a top end view of the medical device of FIG.
1;
[0029] FIG. 3 is a partial perspective view of the medical device
of FIG. 1;
[0030] FIG. 4A is a rear (plan) view of the medical device of FIG.
1 with a test module;
[0031] FIG. 4B is a rear (plan) view of the medical device of FIG.
1 without the test module;
[0032] FIG. 5 is an inner perspective view of the test module;
[0033] FIG. 6A is a side view of the medical device of FIG. 1
before the test module is attached to the main body of the medical
device;
[0034] FIG. 6B is cross-sectional end view of the medical device of
FIG. 6A taken along line 6B-6B of FIG. 6A;
[0035] FIG. 6C is an enlarged cross-sectional end view of the
portion of the medical device within circle 6C of FIG. 6B;
[0036] FIG. 7A is a side view of the medical device of FIG. 1 while
the test module is being attached to the main body of the medical
device;
[0037] FIG. 7B is cross-sectional end view of the medical device of
FIG. 7A taken along line 7B-7B of FIG. 7A;
[0038] FIG. 7C is an enlarged cross-sectional view of the portion
of the medical device within circle 7C of FIG. 7B;
[0039] FIG. 7D is partial cross-sectional plan view of the medical
device of FIG. 7A taken along line 7D-7D of FIG. 7A;
[0040] FIG. 8A is a side view of the medical device of FIG. 1 after
the test module is attached to the main body of the medical
device;
[0041] FIG. 8B is cross-sectional end view of the medical device of
FIG. 8A taken along line 8B-8B of FIG. 8A;
[0042] FIG. 8C is an enlarged cross-sectional view of the portion
of the medical device within circle 8C of FIG. 8B;
[0043] FIG. 8D is partial cross-sectional plan view of the medical
device of FIG. 8A taken along line 8D-8D of FIG. 8A;
[0044] FIG. 9A is a side view of the medical device of FIG. 1
during removal of the test module where the test module is rotated
at an angle A of 5 degrees relative to the x-y plane and
longitudinal axis LA;
[0045] FIG. 9B is a side view of the medical device of FIG. 1
during removal of the test module where the test module is rotated
at an angle A of 15 degrees relative to the x-y plane and
longitudinal axis LA;
[0046] FIG. 10 is an inner view of a cover of the test module of
the medical device of FIG. 1 before assembly of the electronic
components with the cover;
[0047] FIG. 11 an inner view of the test module of the medical
device of FIG. 1 after assembly of the electronic components with
the cover;
[0048] FIG. 12 is a close-up inner view of the test module of FIG.
11 without the electronic components;
[0049] FIG. 13 is close-up inner view of the test module of FIG.
11;
[0050] FIG. 14 a perspective view of a light guide of the test
module of the medical device of FIG. 1;
[0051] FIG. 15 is a perspective view of the light guide and a seal
of the test module of the medical device of FIG. 1;
[0052] FIG. 16 is a cross-sectional side view of the test module of
the medical device of FIG. 5 taken along line 16-16 of FIG. 13
without the cover; and
[0053] FIG. 17 is a cross-sectional side view of the medical device
of FIG. 1 taken along line 17-17 of FIG. 1 with a test strip
inserted in the test strip port.
DETAILED DESCRIPTION
[0054] It may be appreciated that the present disclosure is not
limited in its application to the details of construction and the
arrangement of components set forth in the following description or
illustrated in the drawings. The invention(s) herein may be capable
of other embodiments and of being practiced or being carried out in
various ways. Also, it may be appreciated that the phraseology and
terminology used herein is for the purpose of description and
should not be regarded as limiting as such may be understood by one
of skill in the art.
[0055] By way of brief introduction, the present disclosure
discloses medical devices, particularly diagnostic (fluid testing)
medical devices which make use of a test strip to test bodily fluid
of a person or animal. More particularly, the diagnostic medical
devices may be blood glucose meters, which are used as diagnostic
devices to a determine blood glucose level of a person or animal
having diabetes mellitus.
[0056] Referring now to the drawings, particularly FIGS. 1-5, there
is shown a handheld, electronic, diagnostic (fluid testing) medical
device 10, and more particularly a blood glucose meter. As shown,
device 10 includes a test strip port 32. As best shown in FIGS.
2-3, test strip port 32 comprises a test strip receptacle 34 to
receive a disposable test strip 2 therein (see e.g. FIG. 17). More
particularly test strip 2 may be a blood glucose test strip. While
medical device 10 may be referred to in particular embodiments
herein as a blood glucose meter, the disclosure should not be
understood as being limited to blood glucose meters.
[0057] Blood glucose meter 10 includes comprises a main body 12.
Among other features, main body 12 includes a visual output display
panel 14 to display test results.
[0058] Main body 12 also includes an enclosure 16 which contains
the visual display 14. Enclosure 16 comprises a front housing 18
and a rear housing 20 which provide a housing to protect at least a
portion of the main body electronic components contained in the
blood glucose meter 10.
[0059] Blood glucose meter 10 also includes a removable/detachable
and replaceable/reattachable test module 30 which includes the test
strip port 32. However, the configuration of the test module 30 and
main body 12, and more particularly the following assembly/latching
mechanism, may inhibit disassembly/unlatching of the test module 30
by a patient, or other individual/person unauthorized for such
removal.
[0060] As shown, test module 30 may be mechanically fastened to the
main body, particularly by two mechanical fasteners 22, which may
particularly comprise threaded fasteners such as screws.
[0061] Test module 30 comprises a test module cover 36 to which
electronic components 40 of the test module 30 are fastened, which
includes at least one printed circuit board.
[0062] Referring now to FIGS. 6A-8D, the test module 30 may be
assembled to the main body 12 with a snap-fit connection by being
pressed onto the main body 12, particularly with an assembly force
F being applied to the test module 30 transverse to a Cartesian
plane CP (parallel with the z-axis) of the main body 12, which may
be understood as the x-y reference plane of the Cartesian x, y, z
coordinate system (shown in FIGS. 1 and 2).
[0063] More particularly, in addition to the use of separate
mechanical fasteners 22, test module 30 may also be detachably
fastened to main body 12 by a positive mechanical engagement which
provides the snap-fit connection. As shown in FIGS. 6A-6C, the
positive mechanical engagement may be created by two opposing
engagement tabs 44 provided on the lateral outer sides of resilient
cantilevered arms 46 of the main body 12, which enter two opposing
mating engagement tab receptacles 48, respectively, formed in the
cover 36.
[0064] During assembly, as shown in FIGS. 7A-7D, and more
particularly FIG. 7C, each engagement tab 44 of resilient
cantilevered arms 46 bears against an inwardly directed opposing
engagement tab 49 of test module cover 36, respectively forcing
each cantilevered arm 46 to move inwards from an initial first
position (as shown in FIG. 6C) and deflect with elastic deformation
towards one another, which inward deflection is biased by the
resiliency thereof. More particularly, each cantilevered arm 46 may
rotate about the z-axis in the x-y (Cartesian) plane, with each arm
moving predominately in the x direction towards the center of the
main body 12.
[0065] As shown in FIG. 7C, once each cantilevered arm 46 moves to
a second position at which the arm 46 deflects inwards a sufficient
distance to enable the engagement tabs 44 of each arm 46 to clear
the opposing engagement tab 49 of test module cover 36, and enter
engagement tab receptacles 48 provided by the test module cover 36,
the resiliency of each cantilevered arms 46 may then return each
cantilevered arm 46 to its first position as shown in FIGS. 8A-8D,
and more particularly FIG. 8C. More particularly, as each
engagement tab 44 enters the engagement tab receptacle 48 formed in
the test module cover 36, the cantilevered arms 46 rotate outwards
to form the positive mechanical engagement and complete assembly of
the overlap snap fit connection.
[0066] Once assembled, transversely extending peripheral lip 43 and
ribs 37 (FIG. 5) of the test module 30 may positively mechanically
engage within a mating transverse peripheral groove 45 and rib
receptacles 39 (transverse to the x-y plane) of the main body 12,
respectively, to inhibit the test module 30 from sliding off the
main body 12 along the x-y plane.
[0067] As set forth above, the test module 30 may be initially
secured by mechanical fasteners 22. However, the mechanical
fasteners 22 may be removed in the field. To thwart disassembly of
test module 30 in the absence of mechanical fasteners 22, as also
explained above, the test module 30 is first configured to inhibit
being slid off the main body 12 along the x-y plane. Furthermore,
the positive mechanical engagement formed between the main body 12
and test module 30 inhibits the test module 30 from being separated
transverse to the x-y plane.
[0068] Referring now to FIGS. 9A-9B, in order to disassemble test
module 30 from the main body 12 after the removal of mechanical
fasteners 22, the test module 30 may be rotated relative to the
main body 12. More particularly, the test module 30 may be rotated
about an axis transverse to the longitudinal axis LA (e.g. x-axis),
which is shown further as a center axis, particularly by lifting
laterally extending medial edge 47 of test module cover 36. In such
manner, a medial region 41 of the test module 30 may be lifted
relative to a peripheral region 42 of the test module 30. As the
medial region 41 of the test module 30 is raised, such may cause
each engagement tabs 44 on the lateral outer sides of resilient
cantilevered arms 46 of the main body 12 to once again bear against
inwardly directed opposing engagement tab 49 of test module cover
36, respectively forcing each cantilevered arm 46 to cantilever
inwards, forcing each cantilevered arm 46 to deflect inwards with
elastic deformation towards one another, which is biased by the
resiliency thereof. Once each cantilevered arm 46 deflects inwards
a sufficient distance to enable the engagement tabs 44 to clear
engagement tabs 49 and exit engagement tab receptacles 48 formed in
cover 36, the test module 30 is passively released and the
resiliency of each cantilevered arms 46 may then return each
cantilevered arm 46 to its first position.
[0069] The configuration of the test module 30 and main body 12,
and more particularly the foregoing disassembly mechanism, is
configured to passively release the test module 30 when the test
module 30 is rotated at an angle A of 5-30 degrees relative to the
longitudinal axis LA, and more particularly 10-20 degrees relative
to the longitudinal axis LA.
[0070] Now, to further thwart undesirable disassembly of the test
module 30, as the medial region 41 of the test module 30 is lifted
relative to a peripheral region 42 of the test module 30, the force
required to lift the medial region increases (due to increasing
resistance of the positive mechanical engagement) as the angle A
increases, until the test module 30 is passively released. In light
of such, to a person untrained in disassembly of the test module
30, the increase in force to lift the medial region 41 may give an
impression that the test module 30 may break if lifted in a manner
as set forth above, causing attempted disassembly to be abandoned.
However, no portion of the main body 12 or test module 30 is
intended to break.
[0071] From the foregoing description, a medical device 10 is
provided in which the test module cover 36 is engageable to the
main body 12 by engagement of a snap-fit connection and
disengageable from the main body 12 by disengagement of the
snap-fit connection. More particularly, the snap-fit connection is
engageable by translational motion of the test module cover 36
relative to the main body 12, and disengageable by rotational
motion of the test module cover 36 relative to the main body 12,
while not being disengageable by translational motion of the test
module cover 36 relative to the main body 12. It should be
understood that medical device 10 may be any electronic device, and
not be limited to a medical device.
[0072] Furthermore, it should be understood that the main body 12
comprises a center axis, such as the longitudinal axis LA, and the
cantilevered arms 46 are arranged to move towards and away from the
center axis, particularly during engagement/disengagement of the
snap-fit connection. More particularly, the cantilevered arms 46
are arranged to move towards each other, as well as away from each
other during engagement/disengagement of the snap-fit
connection.
[0073] Turning to operation of the test module 30, and FIGS. 10-17,
the entrance to the test strip receptacle 34 is provided by a
narrow slot (through hole) 38 formed in the test module cover 36.
Referring particularly to FIG. 16, the test strip receptacle 34
thereafter extends through seal 50, light guide 52 and into a test
strip connector 54, which electrically couples test strip 2 to the
electronic components 40 of the test module 30. Once a test strip 2
is inserted within test strip receptacle 34 and properly seated
therein, and blood is placed thereon, the blood glucose meter 10
may then determine a blood glucose level by measuring electrical
current passed through the electrical contacts of the test strip 2
in a known manner, and provide a determination of the glucose
concentration level in the blood.
[0074] In order to light the test strip port 32 to assist in proper
placement of a test strip 2 in the test strip port 32 at night or
otherwise low light conditions, light guide 52 receives light from
a light emitting source 24 of the blood glucose meter 10 which may
be located in the main body 12 (see FIG. 17). Light emitting source
24 may comprise at least one light emitting diode (InGaN, water
clear lens, viewing angle 120.degree./20.5) which emits white
(visible) light in a wavelength of 390-700 nm (or frequency range
of 430-770 THz) and a luminous intensity in a range of 200-900
millicandela, and more particularly 400-700 millicandela, when
tested in accordance with CIE127-2007 (I.sub.F=5 mA) standards.
[0075] As best shown by FIGS. 14-15, light guide 52 includes a
U-shaped section 60 and an oblong annular ring section 62 defining
a slot (through hole) 64. As shown, U-shaped section 60 includes a
horizontal center span 66 disposed between two spaced apart
vertical stanchions 72 which are transverse to the center span 66.
Center span 66 includes a centrally disposed cylindrical light
receiving post 68 having a planar, circular light receiving surface
70 arranged to receive light from the light emitting source 24 of
the main body 12.
[0076] As shown by FIG. 12-13, the vertical stanchions 72 of the
U-shaped section 60 are fastened to the inner surface of test
module cover 36, particularly by adhesive. The center span 66 and
the stanchions 72 form a recess pocket 74 which contains an end lip
portion 56 of test strip connector 54. Together, the center span 66
of the U-shaped section 60 of the light guide 52 and the end lip
portion 56 of test strip connector 54 define a portion of the test
strip receptacle 34, including a slot 76 therebetween to
accommodate test strip 2 as it extends through slot 38 in the test
module cover 36, slot 64 in the oblong annular ring section 62 of
the light guide 52 and completely into test strip connector 54.
[0077] In order to transmit light, light guide 52 is formed of a
light transmissive polymer composition. As used herein, a light
transmissive polymer composition may be characterized as providing
integral transmission of at least 60% of incident light in the
visible spectrum (about 400-700 nm wavelength), and more preferably
at least 70% of incident light in the visible spectrum, and even
more preferably, at least 80% or 90% of incident light in the
visible spectrum. A light transmissive polymer composition may be
optically translucent and, more preferably, an optically
transparent. The light transmissive polymer composition may be a
thermoplastic polymer composition which is suitable for injection
molding. The thermoplastic light transmissive polymer composition
may comprise at least one transparent polymer such as
polycarbonate, polyurethane, polystyrene and polymethyl
methacrylate.
[0078] With the foregoing arrangement, the light emitting source 24
is arranged to emit light inside the medical device 10. In
addition, the light emitting source 24 and the test strip port 32
are arranged such that, when the light emitting source 24 emits
light, at least a portion of the light emitted from the light
emitting source 24 is redirected inside the medical device 10 to
provide redirected light inside the medical device 10, and at least
a portion of the redirected light lights the test strip port 32
from inside the medical device 10.
[0079] More particularly, the light guide 52 is arranged to receive
light emitted from the light emitting source 24 and redirect at
least a portion of the light from the light emitting source 24
towards the light guide annular ring 62 to light the light guide
annular ring 62 from inside the medical device 10.
[0080] More particularly, the light emitting source 24 is arranged
such that, when a test strip 2 is received into the test strip port
receptacle 34, the light from the light emitting source 24 is aimed
substantially transverse to a longitudinal axis of the test strip 2
and towards the test strip 2. The light guide 52 is arranged to
redirect at least a portion of the light from the light emitting
source 24 approximately ninety degrees towards the light guide
annular ring 62 such that the redirected light travels
substantially parallel to the longitudinal axis of the test strip
2.
[0081] When light is emitted from light emitting source 24 into
light receiving post 68 of light guide 52, light guide 52 is
configured such that the light from the oblong annular ring section
62 of the light guide 52 will be emitted in the form of annular
ring around the test strip 2, which may be oriented substantially
parallel with the longitudinal axis of the test strip 2 upon
insertion of the test strip 2 into the test strip port 32.
[0082] While blood glucose meter 10 may be configured to
automatically light the test strip port 32 in response to receiving
a test strip 2 therein, blood glucose meter 10 may also be
configured to light test strip port 32 in response to manual push
button activation, such as by pushing activation (on/off) button 26
as shown in FIGS. 2 and 3. To save power, the blood glucose meter
10 may include an ambient light sensor 28 to disable such
functionally when ambient light is above a predetermined level.
[0083] While visible (white) light may be preferred to light the
test strip 2, light emitting source 24 may be configured to emit
various individual colors of the electromagnetic spectrum. For
example, the light emitting source 24 may emit red (620-700 nm),
yellow (570-590 nm) or green (495-565 nm) light as an indicator of
port status (e.g. green is ready for use, yellow is not ready for
use and red is to report an error), or the light may blink to
remind the patient to test their blood glucose level.
[0084] Test strip port 32 may also be protected from egress of
solid particulate as well as liquid by seal 50. Similar to light
guide 52, seal 50 includes an oblong annular ring section 92
defining a slot (through hole) 94. Oblong annular ring section 92
is disposed on an intermediate section 80 of the light guide 52
disposed between a shoulder 82 of the U-shaped section 60, and the
oblong annular ring section 62. Oblong annular ring section 92
forms a seal against the shoulder 82 of the U-shaped section 60 and
the inner surface of test module cover 36 surrounding slot 38
formed in the test module cover 36. In this manner, external debris
is inhibited from entering test strip port 32 between seal 50 and
test module cover 36.
[0085] Oblong annular ring section 92 further includes an
elastically deformable U-shaped entrance door flap 96 which is in a
closed position when test strip 2 is not within the test strip port
32, and which may rest against (i.e. be in connect with the inner
side of oblong annular ring section 62 of light guide 52. At this
time, the entrance door flap 96 is in a closed position which
substantially closes slot 64 of the light guide 52 to inhibit
external debris from entering test strip port 32, and more
particularly inhibits debris from entering the test strip
receptacle 34 beyond slot 64 in the oblong annular ring section 62
of the light guide 52.
[0086] When test strip 2 is inserted within test strip port 32,
elastically deformable entrance door flap 96 deforms elastically
inward, particularly along a hinge portion 98, upon being contacted
by test strip 2 to open slot 64 in the oblong annular ring section
62 of the light guide 52 and correspondingly open slot 94 in the
oblong annular ring section 92 of seal 50. Entrance door flap 96
may rotate at an angle .theta. in a range of, for example of 60 to
90 degrees.
[0087] Seal 50 may be particularly formed of an elastomeric polymer
composition. As used herein, an elastomeric polymer composition may
be characterized as a composition that has an elongation at
23.degree. C. of at least 100%, and which, after being stretched to
twice its original length and being held at such for one minute,
may recover in a range of 50% to 100% within one minute after
release from the stress. More particularly, the elastomeric polymer
composition may recover in a range of 75% to 100% within one minute
after release from the stress, and even more particularly recover
in a range of 90% to 100% within one minute after release from the
stress. The elastomeric polymer composition may be a composition
with a Tg below room temperature and which is at most, 50%
crystalline (i.e., the material contains an amorphous phase of 50%
or greater, up to 100% amorphous phase). The elastomeric polymer
composition may comprise a thermoplastic polymer composition which
is suitable for injection molding. The elastomeric polymer
composition may comprise at least one thermoplastic elastomer, such
as styrene block polymers, such as styrene block copolymers (e.g.
styrene-butadiene copolymer) and styrene block terpolymers (e.g.
styrene-butadiene-styrene terpolymer,
styrene-ethylene/butylene-styrene terpolymer,
styrene-ethylene/propylene-styrene terpolymer); polyolefin blends
(e.g. polypropylene and ethylene-propylene-diene monomer rubber,
polypropylene and nitrile rubber, ethylene-propylene rubber);
elastomeric alloys such as melt-processable rubbers and
thermoplastic vulcanizates; polyolefins; polyurethanes; polyesters;
and rubbers such as natural rubber, neoprene rubber, acrylic
rubber, butadiene rubber, butyl rubber, ethylene-propylene rubber,
ethylene propylene diene monomer rubber, fluorocarbon rubber,
isoprene rubber, nitrile rubber, polyurethane rubber and silicone
rubber.
[0088] The seal 50 may also be formed of a rigid polymer
composition, particularly where the hinge portion 98 may be
configured as a living hinge. Example materials include
polypropylene or acrylonitrile-butadiene-styrene.
[0089] Furthermore, the elastomeric polymer composition of seal 50
may also be a light transmissive polymer composition. As used
herein, a light transmissive polymer composition may be
characterized as providing integral transmission of at least 60% of
incident light in the visible spectrum (about 400-700 nm
wavelength), and more preferably at least 70% of incident light in
the visible spectrum, and even more preferably, at least 80% or 90%
of incident light in the visible spectrum. A light transmissive
polymer composition may be optically translucent and, more
preferably, an optically transparent.
[0090] With the foregoing constriction, seal 50 of the test strip
port 32 of blood glucose meter 10 may passively seal to inhibit
external debris, liquid (e.g. water) and solid (e.g. dirt), from
entering the test strip port. More particularly, test strip port 32
may be sealed to meet IP22 fluid and particulate ingress
requirements for home use medical products per International
Electrotechnical Commission International Standard IEC
60529:1989+A1:1999(E), which is incorporated herein by
reference.
[0091] The IP Code, International Protection Marking or IEC
standard 60529, sometimes interpreted as Ingress Protection Marking
or IP Rating, classifies and rates the degree of protection
provided against intrusion (body parts such as hands and fingers),
dust, accidental contact, and water by mechanical casings and
electrical enclosures. It is published by the International
Electrotechnical Commission (IEC) as noted above.
[0092] For example, an electrical socket rated IP22 is protected
against insertion of fingers and will not be damaged or become
unsafe during a specified test in which it is exposed to vertically
or nearly vertically dripping water. The first digit indicates the
level of protection that the enclosure provides against ingress of
solid foreign objects. A level of 2 corresponds to the enclosure
providing protection against ingress of objects greater than 12.5
mm, which is effective against fingers or similar objects. The
second digit indicates the level of protection that the enclosure
provides against harmful ingress of water. A level of 2 corresponds
to the enclosure providing protection against ingress of dripping
water when tilted up to 15 degrees (i.e. vertically dripping water
shall have no harmful effect when the enclosure is tilted at an
angle up to 15.degree. from its normal position). The enclosure is
tested for 10 minutes, with a water equivalent to 3 mm rainfall per
minute.
[0093] Furthermore, when light is emitted from light emitting
source 24 into light receiving post 68 of light guide 52, light
guide 52 is configured such that light will be transmitted and
directed into the oblong annular ring section 92 of seal 50 such
that light from the oblong annular ring section 92 of the seal 50
will be emitted in the form of annular ring around the test strip
2.
[0094] Moreover, when light is emitted from light emitting source
24 into light receiving post 68 of light guide 52, light guide 52
is configured such that light will be transmitted and directed into
the door flap 96 of seal 50 such that light will be emitted from
the door flap 96 of the seal 50.
[0095] In addition to the foregoing, medical device 10 may also
provide protection against electrostatic discharge (ESD). For
example, medical device 10 may comply with International Standard
IEC 60601-2-24:2012, as tested per IEC 61000-4-2: 2008,
incorporated by reference, (Electromagnetic compatibility
(EMC)--Part 4: Testing and measurement techniques--Section 2:
Electrostatic Discharge Immunity Test) at a level of +/-8 kV
contact discharge and +/-15 Kv air discharge.
[0096] While the principles of the invention have been described
herein, it is to be understood by those skilled in the art that
this description is made only by way of example and not as a
limitation as to the scope of the invention. Other embodiments are
contemplated within the scope of the present invention in addition
to the exemplary embodiments shown and described herein.
Modifications and substitutions by one of ordinary skill in the art
are considered to be within the scope of the present invention,
which is not to be limited except by the following claims.
LIST OF REFERENCE CHARACTERS
[0097] 2 test strip [0098] 10 medical device [0099] 12 main body
[0100] 14 visual display [0101] 16 main body enclosure [0102] 18
front housing [0103] 20 rear housing [0104] 22 mechanical fasteners
[0105] 24 light emitting source [0106] 26 light emitting source
activation (on/off) push button [0107] 28 ambient light sensor
[0108] 30 test module [0109] 32 test strip port [0110] 34 test
strip receptacle [0111] 36 test module cover [0112] 37 ribs [0113]
38 test module cover slot [0114] 39 rib receptacles [0115] 40 test
module electronic components [0116] 41 medial region [0117] 42
peripheral region [0118] 43 transverse lip [0119] 44 engagement tab
[0120] 45 transverse groove [0121] 46 cantilevered arm [0122] 47
medial edge [0123] 48 engagement tab receptacle [0124] 49
engagement tab [0125] 50 seal [0126] 52 light guide [0127] 54 test
strip connector [0128] 56 test strip connector end portion [0129]
60 U-shaped section [0130] 62 oblong annular ring section [0131] 64
oblong annular ring section slot [0132] 66 center span [0133] 68
light receiving post [0134] 70 light receiving surface [0135] 72
stanchion [0136] 74 recess pocket [0137] 76 slot [0138] 80
intermediate section [0139] 82 shoulder [0140] 92 oblong annular
ring section [0141] 94 oblong annular ring section slot [0142] 96
entrance door flap [0143] 98 hinge portion [0144] A angle
* * * * *