U.S. patent application number 11/985376 was filed with the patent office on 2008-05-22 for button layout for a testing instrument.
Invention is credited to G. Lamar Kirchhevel, Russell J. Micinski.
Application Number | 20080118401 11/985376 |
Document ID | / |
Family ID | 46150196 |
Filed Date | 2008-05-22 |
United States Patent
Application |
20080118401 |
Kind Code |
A1 |
Kirchhevel; G. Lamar ; et
al. |
May 22, 2008 |
Button layout for a testing instrument
Abstract
A sensor dispensing instrument adapted to handle a sensor pack
containing a plurality of sensors and to perform a test using one
of the sensors. The sensor dispensing instrument includes an outer
housing and display disposed on the outer housing for showing
items. The sensor dispensing instrument further comprises a power
button for turning the sensor dispensing instrument on and off, a
scroll button for scroll through the items, and a select button for
selecting an item.
Inventors: |
Kirchhevel; G. Lamar;
(Laguna Niguel, CA) ; Micinski; Russell J.; (South
Bend, IN) |
Correspondence
Address: |
NIXON PEABODY LLP
161 N. CLARK STREET
48TH FLOOR
CHICAGO
IL
60601
US
|
Family ID: |
46150196 |
Appl. No.: |
11/985376 |
Filed: |
November 15, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10237995 |
Sep 10, 2002 |
7323141 |
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11985376 |
Nov 15, 2007 |
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10207758 |
Jul 30, 2002 |
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10237995 |
Sep 10, 2002 |
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60311759 |
Aug 13, 2001 |
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Current U.S.
Class: |
422/68.1 ; 221/2;
221/258 |
Current CPC
Class: |
Y10T 436/2575 20150115;
G07F 11/54 20130101; Y10T 436/112499 20150115; Y10T 436/144444
20150115; Y10T 436/11 20150115; G01N 33/4875 20130101 |
Class at
Publication: |
422/068.1 ;
221/258; 221/002 |
International
Class: |
B01J 19/00 20060101
B01J019/00; B65H 79/00 20060101 B65H079/00; B65H 26/00 20060101
B65H026/00 |
Claims
1-20. (canceled)
21. A sensor-dispensing instrument adapted to handle a sensor pack
containing a plurality of sensors, the sensor-dispensing instrument
further adapted to perform a test using one of the plurality of
sensors, the sensor-dispensing instrument comprising: a circuit
board assembly including a plurality of contacts on a bottom
surface thereof; a cover mechanism including a plurality of
fingers, each of the plurality of fingers adapted to contact at
least one of the plurality of contacts on the bottom surface of the
circuit board assembly; a pusher assembly including a plurality of
ramp contacts; and a motor adapted to cause the movement of at
least one of the plurality of ramp contacts, wherein movement of at
least one of the plurality of ramp contacts pushes at least one of
the plurality of fingers into contact with at least one of the
plurality of bottom surface contacts, resulting in the
sensor-dispensing instrument being electronically turned to an ON
state.
22. The instrument of claim 21 wherein the motor is activated by a
button.
23. The instrument of claim 21 wherein the number of the plurality
of fingers and the number of the plurality of bottom surface
contacts are the same.
24. The instrument of claim 21 further including an outer housing,
a knife-blade, and an alarm, the knife-blade having an extended
position, and wherein when the outer housing is in an open position
and the handle is in an extended position, the alarm is activated
to indicate the possibility that the knife-blade is in the extended
position.
25. The instrument of claim 21 wherein the sensor-dispensing
instrument is a blood glucose meter.
26. The instrument of claim 21 wherein at least one of the
plurality of fingers is in a permanent upward position such that
none of the plurality of ramp contacts moves the at least one of
the plurality of fingers.
27. A method of using a sensor-dispensing instrument, the
sensor-dispensing instrument adapted to handle a sensor pack
containing a plurality of sensors, the sensor-dispensing instrument
further adapted to perform a test using one of the plurality of
sensors, the method comprising the acts of: providing a
sensor-dispensing instrument comprising a motor, a circuit board
assembly, a cover mechanism and a pusher assembly, the circuit
board assembly including a plurality of contacts on a bottom
surface thereof, the cover mechanism including a plurality of
fingers, the pusher assembly including a plurality of ramp
contacts; and activating the motor such that at least one of the
plurality of ramp contacts moves at least one of the plurality of
fingers into contact with at least one of the plurality of bottom
surface contacts, resulting in the sensor-dispensing instrument
being electronically turned to an ON state.
28. The method of claim 27 wherein the motor is activated by a
button.
29. The method of claim 27 wherein each of the plurality of fingers
is adapted to contact a respective one of the plurality of bottom
surface contacts of the circuit board assembly.
30. The method of claim 27 wherein the sensor-dispensing instrument
is a blood glucose meter.
31. The method of claim 27 wherein each of the plurality of fingers
have a raised convex section.
32. The method of claim 27 wherein at least one of the plurality of
fingers is in a permanent upward position such that none of the
plurality of ramp contacts moves the at least one of the plurality
of fingers.
33. A testing instrument comprising: a sensor pack containing a
plurality of sensors; an outer housing having an opening through
which at least one of the plurality of sensors is disposed to
conduct a test, wherein the outer housing includes a display for
displaying a plurality of items; an electronics assembly including
a microprocessor for operating the testing instrument and storing
data; and a plurality of controllers connected through the
electronics assembly and adapted to control the operation of the
testing instrument, the controllers including a power control for
turning the sensor dispensing instrument on and off, a display
control for viewing at least one of the plurality of items on the
display, a select control for selecting at least one of the
plurality of items, a memory control for displaying test results,
and a set-up control for performing tasks related to the operation
of the testing instrument.
34. The testing instrument of claim 33, wherein the outer housing
forms a plurality of openings, and wherein the power control, the
display control, the select control, the memory control and the
set-up control are mounted through respective ones of the plurality
of openings in the outer housing.
35. The testing instrument of claim 33, further comprising a
controller door pivotally connected to the outer housing, wherein
the controller door is moveable between a closed position and an
open position, wherein the controller door covers the power
control, the select control, the display control, the memory
control and the set-up control when in the closed position, and
wherein the controller door allows access to the power control, the
display control, the select control, the memory control and the
set-up control when in the open position.
36. The testing instrument of claim 35, wherein the controller door
forms an opening and wherein the power control extends in the
opening when the controller door is in the closed position.
37. The testing instrument of claim 33, further comprising an
indexing disk with a plurality of pins, the plurality of pins
assisting in properly aligning the sensor pack.
38. The testing instrument of claim 33, wherein the power control,
the select control, the display control, the memory control and the
set-up control each have a contact surface, and wherein the
distance from the top surface of the outer housing to the contact
surface of the power control is greater than the distance from the
top surface of the outer housing to the contact surfaces of the
select control, the display control, the memory control and the
set-up contro.
39. The testing instrument of claim 33, further comprising a
communication interface for transferring or receiving testing
information from a second device.
40. A method of operating a testing instrument comprising:
providing the testing instrument, the testing instrument including
a sensor pack containing a plurality of sensors, an electronics
assembly including a microprocessor for operating the sensor
dispensing instrument and storing data, an outer housing having an
opening through which at least one of the plurality of sensors is
disposed to conduct a test and a display for displaying a plurality
of items, and a plurality of controllers connected through the
electronics assembly to control the operation of the testing
instrument, the controllers including a power control, a display
control, a select control, a memory control and a set-up control;
activating the power control to activate the display and turn the
testing instrument on; activating the display control to view the
items on the display; activating the select control to select at
least one item; activating the memory control to view test results;
and activating the set-up control to perform tasks relating to the
operation of the testing instrument.
41. The method of claim 40, wherein activating the set-up control
includes adjusting the time and date and programming numbers for
reagent calibration.
42. The method of claim 40, further comprising aligning the sensor
pack using an indexing disk.
43. The method of claim 40, wherein the testing instrument further
comprises a controller door, the method further comprising moving
the controller door between a closed position and an open position,
the open position allowing a user to activate at least one of the
plurality of controllers.
44. The method of claim 40, wherein activating the display control
includes scrolling through a list of items or a series of test
results stored in the testing device.
45. A sensor dispensing instrument adapted to perform a test using
a sensor, and comprising: a sensor pack containing a plurality of
sensors; an outer housing having an opening through which at least
one of the plurality of sensors is disposed to conduct a test,
wherein the outer housing includes a display for displaying a
plurality of items; an electronics assembly including a
microprocessor for operating the sensor dispensing instrument and
storing data; and a plurality of controllers connected through the
electronics assembly and adapted to control the operation of the
sensor dispensing instrument, the controllers including a power
control for turning the sensor dispensing instrument on and off, a
display control for viewing at least one of the plurality of items
on the display, a select control for selecting at least one of the
plurality of items, a memory control for displaying test results,
and a set-up control for performing tasks related to the operation
of the sensor dispensing instrument.
Description
[0001] This application is a continuation-in-part application of
provisional application No. 60/311,759, entitled "Mechanical
Mechanism For A Blood Glucose Sensor Dispensing Instrument,"
MSE#2642, filed on Aug. 13, 2001.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention generally relates to a fluid
monitoring system, and, more particularly, to a new and improved
button layout for a testing instrument for handling sensors that
are used in analyzing blood glucose or other analytes contained
therein.
[0004] 2. Description of the Prior Art
[0005] People suffering from various forms of diabetes routinely
need to test their blood to determine the level of blood glucose.
The results of such tests can be used to determine what, if any,
insulin or other medication needs to be administered. In one type
of blood glucose testing system, sensors are used to test a sample
of blood.
[0006] Such a sensor may have a generally flat, rectangular shape
with a front or testing end and a rear or contact end. The sensor
contains biosensing or reagent material that will react with blood
glucose. The testing end of the sensor is adapted to be placed into
the fluid being tested, for example, blood that has accumulated on
a person's finger after the finger has been pricked. The fluid is
drawn into a capillary channel that extends in the sensor from the
testing end to the reagent material by capillary action so that a
sufficient amount of fluid to be tested is drawn into the sensor.
The fluid then chemically reacts with the reagent material in the
sensor with the result that an electrical signal indicative of the
blood glucose level in the blood being tested is supplied to
contact areas located near the rear or contact end of the
sensor.
[0007] In order to couple the electrical signals produced at the
sensor contacts to monitoring equipment, the sensors need to be
inserted into sensor holders prior to the sensor end being placed
into the fluid being tested. The holders have corresponding mating
contact areas that become coupled to the contacts on the sensor
when the sensor is inserted into the holder. Consequently, the
holders act as an interface between the sensor and monitoring
equipment that accumulates and/or analyzes the test results.
[0008] Prior to being used, the sensors need to be maintained at an
appropriate humidity level so as to insure the integrity of the
reagent materials in the sensor. Sensors can be packaged
individually in tear-away packages so that they can be maintained
at the proper humidity level. For instance, blister type packaging
methods could be used. In this configuration, the packages can
include desiccant material to maintain the proper humidity in the
package. In order for a person to use an individual sensor for
testing blood glucose, the package must be opened by tearing the
seal. Alternatively, some packages require the user to exert force
against one side of the package resulting in the sensor bursting or
rupturing the foil on the other side. As can be appreciated, the
opening of these packages can be difficult. Moreover, once the
package is opened, the user needs to be sure that the sensor is not
damaged or contaminated as it is being placed into the sensor
holder and used to test the blood sample.
[0009] U.S. Pat. No. 5,630,986, issued on May 20, 1997, and
entitled Dispensing Instrument For Fluid Monitoring Sensors
(referred to hereinafter as "the '986 patent"), discloses a type of
sensor pack with multiple sensors and a testing blood glucose and
dispensing instrument for handling the sensors contained in such a
sensor pack. In particular, the sensor dispensing instrument
disclosed in the '986 patent is adapted to receive a sensor pack
containing a plurality of blood glucose sensors. The sensor pack
includes a circular base having a plurality of sensor retaining
cavities, each of which hold an individual sensor. Each of the
sensors has a generally flat, rectangular shape with a front
testing end through which fluid is drawn so as to react with a
reagent material in the sensor and an opposite rear, contact
end.
[0010] The sensor instrument disclosed in the '986 patent includes
an outer housing having an upper and a lower case that are
pivotable with respect to each other so that the sensor pack can be
positioned in the housing on an indexing disk disposed in the
housing. With the sensor pack loaded in the housing, a slide latch
on a slide actuator disposed on the upper case of the housing
controls whether the movement of the slide actuator places the
instrument in a display mode or in a testing mode. The instrument
is placed into its display mode when the slide latch is moved
laterally and the slide actuator is pushed away from its standby
position. When in the display mode, a person using the instrument
can view data displayed on a display unit in the upper case and/or
input data into the instrument.
[0011] The instrument is in its testing mode when the slide latch
is in its normal position and the slide actuator is pushed towards
its testing position. As the slide actuator is moved towards its
actuated position, the driver with the knife blade thereon moves
toward the testing position of the feed mechanism and the disk
drive arm travels in a straight, radially extending groove in the
indexing disk such that the disk is not rotated as the feeding
mechanism is moving towards its testing position. The knife blade
is moved towards one of the sensor cavities in the sensor pack and
pierces the foil covering the sensor cavity so as to engage the
sensor disposed in the cavity. As the slide actuator and the driver
are pushed toward the actuated position of the actuator, the knife
blade ejects the sensor out from the sensor cavity and into a
testing position near the testing end of the sensor housing.
[0012] Once the blood analyzing test is completed, the slide
actuator is moved in the opposite direction towards its standby
position so that the sensor can be removed from the dispensing
instrument. The continued retraction of the driver causes the
indexing disk drive arm to travel along a curvilinearly extending
groove in the indexing disk, resulting in the rotation of the
indexing disk. The rotation of the indexing disk results in the
sensor pack being rotated so that the next sensor is positioned in
alignment with the knife blade for the next blood glucose test that
is to be performed.
[0013] Although the sensor instrument disclosed in the '986 patent
overcomes many of the problems discussed above in connection with
the use of individual sensors, the sensor instrument disclosed in
the '986 uses only two buttons labeled "A" and "B" to control all
the functions of the sensor instrument, such as: entering a set-up
mode to adjust the time and date, to program numbers for reagent
calibration, and to set-up audio volume; and entering a memory mode
for viewing the most recent results. Since there are only two
buttons, and since they are labeled "A" and "B," there is no
intuitive indication of what should happen once a button is
pressed. Accordingly, it is desirable to have a sensor dispensing
instrument utilizing an improved button layout that can be more
easily learned and manipulated by users.
BRIEF SUMMARY OF THE INVENTION
[0014] Accordingly, an object of the present invention is to
provide a new and improved sensor dispensing instrument for
handling the sensors contained in a sensor pack of multiple
sensors, each of the sensors disposed in a sensor cavity on said
sensor pack and enclosed by a protective covering. The sensor
dispensing instrument is further adapted to perform a test using
one of said plurality of sensors. The sensor dispensing instrument
includes a display for showing items. The sensor dispensing
instrument also includes a power button for turning the sensor
dispensing instrument on and off, a scroll button for scrolling
through items shown on the display, and a select button for
selecting an item.
[0015] In accordance with another aspect of the present invention,
the present invention is embodied in a glucose meter adapted to
perform a test using a sensor. The glucose meter comprises a
display for showing items. The glucose meter also comprises a power
button for turning the glucose meter on and off, a scroll button
for scroll through the items, and a select button for selecting an
item.
[0016] In accordance with another aspect of the present invention,
the present invention is embodied in a method of operating a
testing instrument adapted to perform a test using at least one
sensor, said testing instrument comprising an outer housing having
a sensor slot through which one of said sensors is disposed to
conduct the test, and said testing instrument further comprising a
display disposed on the outer housing for showing items, a power
button, a scroll button, and a select button The method comprises
pressing the power button to activate the display and turn the
testing instrument on, pressing the scroll button to scroll through
the items, and pressing the select button to select an item.
BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS
[0017] The present invention, together with the above and other
objects and advantages, can best be understood from the following
detailed description of the embodiment of the invention illustrated
in the drawing, wherein:
[0018] FIG. 1 is a top perspective view of a blood glucose sensor
dispensing instrument embodying the present invention;
[0019] FIG. 2 is a bottom perspective view of the blood glucose
sensor dispensing instrument of FIG. 1;
[0020] FIG. 3 is a perspective view of the blood glucose sensor
dispensing instrument of FIG. 1 in the opened position showing the
insertion of a sensor pack;
[0021] FIG. 4 is a perspective view of the blood glucose sensor
dispensing instrument of FIG. 1 in the opened position showing a
sensor pack loaded onto the indexing disk;
[0022] FIG. 5 is a top perspective view of the blood glucose sensor
dispensing instrument of FIG. 1 shown with the button door in the
open position;
[0023] FIG. 6 is a top perspective view of the blood glucose sensor
dispensing instrument of FIG. 1 with the button door in the closed
position;
[0024] FIG. 7 is a top perspective view of the blood glucose sensor
dispensing instrument of FIG. 1 with the disk drive pusher in the
testing position with a sensor projecting from the sensor
opening;
[0025] FIG. 8 is a top perspective view of a sensor for use with
blood glucose sensor dispensing instrument of FIG. 1;
[0026] FIG. 9 is an exploded perspective view of a sensor pack for
use with blood glucose sensor dispensing instrument of FIG. 1
showing the protective foil separated from the base portion of the
sensor pack;
[0027] FIG. 10 is an exploded perspective view of the component
sub-assemblies of blood glucose sensor dispensing instrument of
FIG. 1;
[0028] FIG. 11A is an exploded perspective view of the component
parts of the upper case sub-assembly of the blood glucose sensor
dispensing instrument of FIG. 1;
[0029] FIG. 11B is an exploded perspective view of the component
parts of the buttons of the blood glucose sensor dispensing
instrument of FIG. 1;
[0030] FIG. 11C is a top view of the blood glucose sensor
dispensing instrument of FIG. 1 shown with the button door in the
open position;
[0031] FIG. 11D is a partial cross-sectional view of the blood
glucose sensor dispensing instrument of FIG. 11C taken along line
11D;
[0032] FIG. 12 is an exploded perspective view of the component
parts of the lower case sub-assembly of the blood glucose sensor
dispensing instrument of FIG. 1;
[0033] FIG. 13 is an exploded top perspective view of the component
parts of the disk drive mechanism and indexing disk sub-assembly of
the blood glucose sensor dispensing instrument of FIG. 1;
[0034] FIG. 14A is an exploded bottom perspective view of the
component parts of the disk drive mechanism and indexing disk
sub-assembly of the blood glucose sensor dispensing instrument of
FIG. 1;
[0035] FIG. 14B is a perspective view of the component parts of the
disk drive mechanism of the blood glucose sensor dispensing
instrument of FIG. 1, according to one embodiment;
[0036] FIG. 14C is a perspective view of the component parts of the
disk drive mechanism of the blood glucose sensor dispensing
instrument of FIG. 1, according to one embodiment;
[0037] FIG. 15 is an exploded perspective view of the component
parts of the battery tray sub-assembly of the blood glucose sensor
dispensing instrument of FIG. 1;
[0038] FIG. 16 is an exploded perspective view of the component
parts of the electronics assembly of the blood glucose sensor
dispensing instrument of FIG. 1;
[0039] FIG. 17 is a top perspective view of the electronics
sub-assembly of the blood glucose sensor dispensing instrument of
FIG. 1; and
[0040] FIG. 18 is a bottom perspective view of the electronics
sub-assembly of the blood glucose sensor dispensing instrument of
FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0041] Referring now more specifically to the drawings, therein is
disclosed a blood glucose sensor dispensing instrument generally
designated by the reference numeral 10 and embodying the present
invention. The sensor dispensing instrument 10 includes an outer
housing 12 having an upper case 18 and a lower case 24, the lower
case 24 pivoting on the upper case 18. The upper case 18 is
pivotable with respect to the lower case 24 in a clamshell fashion
so that a sensor pack 300 (see FIGS. 3 and 4) can be positioned on
an indexing disk 30 within the housing 12. With the sensor pack 300
so loaded in the housing 12, a button 32 can be pressed to cause a
disk drive mechanism, generally designated by the numeral 34 (see
FIG. 10), to load a sensor 302 into a testing position on the front
end 14 of the housing 12 (see FIG. 3). The sensor dispensing
instrument also includes a motor 400, a linear drive system 410,
and a power transfer system 420, which cause the disk drive
mechanism 34 to load a sensor 302 into a testing position on the
front end 14 of the housing once the button 32 is pressed, as
described below.
[0042] It should be noted that the sensor dispensing instrument 10
of the present invention incorporates components that are similar
in design and/or function as those described in U.S. Pat. No.
5,630,986, issued May 20, 1997, and entitled Dispensing Instrument
For Fluid Monitoring Sensors. The contents of these patents are
hereby incorporated by reference to avoid the unnecessary
duplication of the description of these similar components.
[0043] The sensor pack 300 utilized by the sensor dispensing
instrument 10 is of the type described in U.S. Pat. No. 5,575,403,
issued Nov. 19, 1996, and entitled Dispensing Instrument For Fluid
Monitoring Sensors, the contents of which are hereby incorporated
by reference. In general, and as shown in FIGS. 8 and 9, the sensor
pack 300 is adapted to house ten sensors 302, with one of the ten
sensors 302 in each of ten separate sensor cavities 304. Each of
the sensors 302 has a generally flat, rectangular shape extending
from a front or testing end 306 to a back end 308. The front end
306 is angled so that it will puncture an unsevered portion of the
protective foil 310 overlying the sensor cavity 304 as the sensor
302 is being forced out of the sensor cavity 304 by a knife blade
36 (to be described below). The front end 306 is also adapted to be
placed into blood that is being analyzed. The back end 308 of the
sensor 302 includes a small notch 312 that is engaged by the knife
blade 36 as the knife blade 36 ejects the sensor 302 from the
sensor cavity 304. Contacts 314 near the back end 308 of the sensor
302 are adapted to mate with metal contacts 38 on a sensor actuator
40 (to be described below) when the sensor 302 is in the testing
position illustrated in FIG. 7. As a result, the sensor 302 is
coupled to the electronic circuitry on the circuit board assembly
42 so that information generated in the sensor 302 during testing
can be stored, analyzed and/or displayed.
[0044] As best seen in FIG. 8, each sensor 302 is provided with a
capillary channel 316 that extends from the front or testing end
306 of the sensor 302 to biosensing or reagent material disposed in
the sensor 302. When the testing end 306 of the sensor 302 is
placed into fluid (for example, blood that is accumulated on a
person's finger after the finger has been pricked), a portion of
the fluid is drawn into the capillary channel 316 by capillary
action. The fluid then chemically reacts with the reagent material
in the sensor 302 so that an electrical signal indicative of the
blood glucose level in the blood being tested is supplied to the
contacts 314, and subsequently transmitted through the sensor
actuator 40 to the circuit board assembly 42.
[0045] As best seen in FIG. 9, the sensor pack 300 comprises a
circularly shaped base portion 318 covered by a sheet of protective
foil 310. The sensor cavities 304 are formed as depressions in the
base portion 318, with each of the sensor cavities 304 adapted to
house an individual sensor 302. Each of the sensor cavities 304 has
an inclined or sloped support wall 320 to guide the sensor 302 as
the sensor 302 is ejected through the foil 310 and out of the
sensor cavity 304.
[0046] Each of the sensor cavities 304 is in fluid communication
with a desiccant cavity 322 formed by a small depression in the
base portion 318. Desiccant material is disposed in each of the
desiccant cavities 322 in order to insure that the sensor cavities
304 are maintained at an appropriate humidity level to preserve the
reagent material in the sensor 302.
[0047] Notches 324 are formed along the outer peripheral edge of
the base portion 318. The notches 324 are configured to engage pins
44 on the indexing disk 30 so that the sensor cavities 304 are in
proper alignment with the indexing disk 30 when the sensor pack 300
is loaded into the sensor dispensing instrument 10. As will be
explained in greater detail below, the sensor cavities 304 must be
aligned with the knife slots 46 in the indexing disk 30 to permit
the knife blade 36 to engage, eject and push one of the sensors 302
into a testing position on the front end 14 of the housing 12.
[0048] The sensor pack 300 further comprises a conductive label 326
on the central portion of the base portion 318. As will be
explained below, the conductive label 326 provides calibration and
production information about the sensor pack 300 that can be sensed
by calibration circuitry in the sensor dispensing instrument
10.
[0049] To operate the sensor dispensing instrument 10, the button
32 is pressed causing an electrical connection (not shown) between
the button 32 and a motor 400 (FIG. 14B) to be made, and therefore
causing the motor 400 to be activated. Upon activation, the motor
400 moves a linear drive system 410 (FIG. 14B) which causes the
disk drive mechanism 34 to rotate the sensor pack 300 and place the
next sensor 302 in a standby position prior to being loaded into a
testing position. The pressing of the button 32 also causes the
sensor dispensing instrument 10 to turn ON (i.e., the electronic
circuitry on the circuit board assembly 42 is activated).
[0050] As will be described in greater detail below, the disk drive
mechanism 34 includes a disk drive pusher 48 on which an indexing
disk drive arm 50 is mounted (see FIG. 14A). The indexing disk
drive arm 50 comprises a cam button 52 disposed at the end of a
plate spring 54. The cam button 52 is configured to travel in one
of a plurality of curvilinearly extending grooves 56 on the upper
surface of the indexing disk 30. As the button 32 is pressed, the
motor 400 is activated, causing the linear drive system 410 to move
the disk drive pusher 48 laterally towards the rear end 22 of the
upper case 18. This causes the cam button 52 on the indexing disk
drive arm 50 to travel along one of the curvilinearly extending
grooves 56 so as to rotate the indexing disk 30. The rotation of
the indexing disk 30 causes the sensor pack 300 to be rotated so
that the next one of the sensor cavities 304 is placed in a standby
position.
[0051] The linear drive system 410 then moves the disk drive pusher
48 laterally towards the front end 20 of the upper case 18 and
causes the disk drive mechanism 34 to remove a sensor 302 from the
sensor pack 300 and place the sensor 302 into a testing position on
the front end 14 of the housing 12.
[0052] As will be described in greater detail below, the disk drive
mechanism 34 includes a knife blade assembly 58 that is pivotally
mounted to the disk drive pusher 48 (see FIGS. 13 and 14A). After
the disk drive pusher 48 is moved laterally towards the rear end 22
of the upper case 18, the disk drive pusher 48 is then pushed
laterally towards the testing or front end 20 of the upper case 18.
This causes the knife blade assembly 58 to pivot downwardly so that
a knife blade 36 on the end of the knife blade assembly 58 pierces
a portion of the protective foil 310 covering one of the sensor
cavities 304 and engages the sensor 302 in the sensor cavity 304.
As the disk drive pusher 48 continues to move towards the front end
20 of the upper case 18, the knife blade assembly 58 forces the
sensor 302 out of the sensor cavity 304 and into a testing position
at the front end 14 of the housing 12.
[0053] While the disk drive pusher 48 is being moved from the
extended position to the testing position, the cam button 52 on the
indexing disk drive arm 50 travels along one of the radially
extending grooves 60 to prevent the indexing disk 30 from rotating.
Similarly, while the disk drive pusher 48 is being moved from the
standby position to the extended position, the knife blade assembly
58 is in a retracted position so as to not interfere with the
rotation of the indexing disk 30.
[0054] After the sensor 302 has been completely ejected from the
sensor cavity 304 and pushed into a testing position projecting out
from the front end 14 of the housing 12, the disk drive pusher 48
engages and forces a sensor actuator 40 against the sensor 302 to
thereby maintain the sensor 302 in the testing position. The sensor
actuator 40 engages the sensor 302 when the button 32 is pressed.
The sensor actuator 40 couples the sensor 302 to an electronics
assembly 62 disposed in the upper case 18. The electronics assembly
62 includes a microprocessor or the like for processing and/or
storing data generated during the blood glucose test procedure, and
displaying the data on a liquid crystal display 64 in the sensor
dispensing instrument 10.
[0055] Once the blood analyzing test is completed, a button release
66 on the upper case 18 is depressed so as to disengage the sensor
actuator 40 and release the sensor 302. Depressing the button
release 66 causes the disk drive pusher 48 and the button 32 to
move from the testing position back to the standby position. At
this point, the user can turn the sensor dispensing instrument 10
OFF by depressing the button 96 on the upper case 18, or by
allowing the sensor dispensing instrument 10 automatically turn OFF
pursuant a timer on the electronics assembly 62.
[0056] As seen in FIGS. 1-7 and 10-12, the upper case 18 and the
lower case 24 of the sensor dispensing housing 12 are
complementary, generally oval shaped hollow containers that are
adapted to be pivoted with respect to each other about pivot pins
68 extending outwardly in the rear end 22 of the upper case 18 into
pivot holes 70 in a rear section 28 of the lower case 24. The upper
case 18 and the lower case 24 are maintained in their closed
configuration by a latch 72 that is pivotally mounted in a front
section 26 of the lower case 24 by pins 74 that extend inwardly
into pivot holes 76 in the latch 72 (see FIG. 12). The latch 72 has
recesses 78 that are configured to mate with hooks 80 on the upper
case 18 to secure the upper case 18 and the lower case 24 in their
closed configuration. The latch 72 is biased in a vertical or
closed position by a latch spring 82. The ends 84 of the latch
spring 82 are secured in slots 86 on the inside of the lower case
24. When the latch 72 is pivoted against the biasing force of the
latch spring 82, the hooks 80 on the upper case 18 disengage from
the recesses 78 to permit the upper case 18 and the lower case 24
to open.
[0057] As seen in FIGS. 1, 5-7 and 10-11A, the upper case 18
includes a rectangular opening 19 through which a liquid crystal
display 64 is visible below. The liquid crystal display 64 is
visible through a display lens 88 that is affixed to upper surface
of the upper case 18. In the preferred embodiment shown, the
display lens 88 has an opaque portion 90 and a transparent portion
92, the transparent portion 92 being coincident with the display
area of liquid crystal display 64. The liquid crystal display 64 is
a component of the electronics assembly 62, and is coupled to the
circuit board assembly 42 via elastomeric connectors 94 (see FIG.
16). The liquid crystal display 64 displays information from the
testing procedure and/or in response to signals input by the
buttons 96 on the upper case 18. For example, the buttons 96 can be
depressed to recall and view the results of prior testing
procedures on the liquid crystal display 64. While a liquid crystal
display 64 is described above, any type of display 65 which can
display information or items can be used, such as, but not limited
to, a cathode ray tube, a plasma screen, and a series of
light-emitting diodes. The display 65 may display items such as,
but not limited to, letters, numbers, symbols, graphical
representations, and the like.
[0058] As best seen in FIG. 11A, the buttons 96 are part of a
button set 98 that is attached to the upper case 18 from below so
that the individual buttons 96 project upwardly through button
openings 100 in the upper case 18. When pressed, the buttons 96 are
electrically connected to the circuit board assembly 42. In one
embodiment, the sensor dispensing instrument 10, and more
specifically, the button set 98, includes a power button 500, a
memory button 502, a set-up button 504, a scroll button 512, and a
select button 514, as illustrated in FIGS. 11A, 11B, 11C, and 11D.
The buttons 500, 502, 504, 512, and 514 are all mounted through
openings 100 in the outer housing 12, and more specifically, the
upper case 18, as illustrated in FIGS. 11A and 11C. The buttons
500, 502, 504, 512, and 514 each have a respective contact surface
522, 524, 525, 526, and 528. In order to engage one of the buttons
500, 502, 504, 512, and 514, a user must press down upon the
respective contact surface 522, 524, 525, 526, and 528, thus
causing a respective buttons 500, 502, 504, 512, and 514 to become
depressed. The outer housing 12 forms a top surface 530 which
defines the openings 100, as illustrated in FIGS. 11A, 11C, and
11D.
[0059] The power button 500 turns the sensor dispensing instrument
10 on and off when engaged. In particular, the power button 500
powers on and off the electronic circuitry on the circuit board
assembly 42. The power button 500 is located in the upper left
corner of the button set 98, when viewed from the top of the sensor
dispensing instrument 10, as illustrated in FIG. 11C. The power
button 500 comprises a power symbol 532 imprinted on the contact
surface 522 of the power button 500, as illustrated in FIG. 11B.
Preferably, the color of the power symbol 532 contrasts with the
color of the power button 500. Preferably, the power symbol 532
comprises a semi-circle and a line, as illustrated in FIGS. 11B and
11C or a complete circle with a vertical line contained therein
(not shown).
[0060] The memory button 502 causes the sensor dispensing
instrument 10 to enter a memory mode when engaged. The memory mode
allows the most recent test results to be immediately viewed on the
display 65 by the user. By engaging the scroll button 512 when in
the memory mode, the user can then scroll up or down through the
test results stored in memory to view a particular test result. The
memory button 502 is located between the power button 502 and the
scroll button 512. The memory button 502 comprises a memory symbol
534 imprinted on the contact surface 524 of the memory button 502,
as illustrated in FIG. 11B. Preferably, the color of the memory
symbol 534 contrasts with the color of the memory button 502.
Preferably, the memory symbol 534 comprises the letter "M," as
illustrated in FIGS. 11B and 11C.
[0061] The set-up button 504 causes the sensor dispensing
instrument 10 to enter a set-up mode when engaged. The set-up mode
allows the user to adjust the time and date, to program numbers for
calibration, to adjust the audio volume, and to perform other such
tasks which would be required to set-up the sensor dispensing
instrument 10. By engaging the scroll button 512 when in the set-up
mode, the user can then scroll up or down through the items shown
within the set-up mode. The set-up button 504 is adjacent the
memory button 502. Preferably, the set-up button is located below
and between the memory button 502 and the power button 500, as
illustrated in FIG. 11C. The set-up button 504 comprises a set-up
symbol 536 imprinted on the contact surface 525 of the set-up
button 504, as illustrated in FIG. 11B. Preferably, the color of
the set-up symbol 536 contrasts with the color of the set-up button
504. Preferably, the set-up symbol 534 comprises an illustration of
a clock, as illustrated in FIGS. 11B and 11C.
[0062] When engaged, the scroll button 512 allows the user to
scroll through items displayed upon the display 65 or stored in
memory within the sensor dispensing instrument 10. The scroll
button 512 allows a user to bi-directionally scroll through a list
of items or a series of test results stored in the memory. For
example, if the desired option or test result is missed, the user
may scroll back until the missed item or test result is found
rather than viewing a complete cycle of the list of items or test
results. In order to accomplish the bi-directional scrolling, the
scroll button 512 includes a scroll up button 506 and a scroll down
button 508. The scroll up button 506 allows the user to scroll
through the list of items or series of test results in a first
direction. The scroll down button 508 allows the user to scroll
through the list of items or series of test results in a second
direction opposed to the first direction. By using the scroll up
button 506 in conjunction with the scroll down button 508, a user
can quickly scroll through a list of items or series of test
results. Preferably, the scroll up button 506 is connected to the
scroll down button 508 through a rocker 510 in order to simplify
the appearance of the scroll button 512, as illustrated in FIGS.
11B and 11C. The scroll button 512 adds the ability for a user to
bi-directionally scroll through any of the functions programmed
within the sensor dispensing instrument 10, such as, setting the
time, setting the date, programming numbers for calibration,
reviewing memory results, and editing memory results. The scroll
button 512 comprises a scroll up symbol 538 and a scroll down
symbol 540 imprinted on the contact surface 526 of the scroll
button 512, as illustrated in FIG. 11B. Preferably, the color of
the scroll up symbol 538 and the scroll down symbol 540 contrasts
with the color of the scroll button 512. Preferably, the scroll up
symbol 538 comprises an arrow pointing up and the scroll down
symbol 540 comprises an arrow pointing down, as illustrated in
FIGS. 11B and 11C.
[0063] The select button 514 allows a user to select an item
displayed upon the display 65 when engaged. The select button 514
may be used to accept a setting, such as the time or date, and then
revert back up to a previous user interface level. The select
button 514 is adjacent the scroll button 512, as illustrated in
FIG. 11C. The select button 514 comprises a select symbol 542
imprinted on the contact surface 528 of the select button 514, as
illustrated in FIG. 11B. Preferably, the color of the select symbol
542 contrasts with the color of the select button 514. Preferably,
the select symbol 542 comprises the letters "OK," as illustrated in
FIGS. 11B and 11C.
[0064] The sensor dispensing instrument 10 comprises a button door
102 pivotally connected to the outer housing 12, as illustrated in
FIGS. 5 and 11C. The button door 102 is movable between a closed
position, as illustrated in FIG. 6, and an open position, as
illustrated in FIG. 5. In one embodiment, the button door 102
covers all the buttons 500, 502, 504, 512, and 514 when in the
closed position. In another embodiment, the button door 102 covers
buttons 502, 504, 512, and 514, but not the power button 500, when
in the closed position, as illustrated in FIG. 6. In this
embodiment, the button door 102 forms an opening 116, and the power
button 500 extends into the opening 116 when the button door 102 is
in the closed position. The button door 102 allows access to all
the buttons 500, 502, 504, 512, and 514 when in the open
position.
[0065] In one embodiment, the power button 500 is taller than the
other buttons 502, 504, 512, and 514. Preferably, the power button
500 is tall enough so that the power button 500 can extends at
least partially through the opening 116 in the button door 102,
thus allowing the user to turn on the sensor dispensing instrument,
perform a test, and then turn off the sensor dispensing instrument
without opening the button door 102. In one embodiment, the power
button 500 is the only button to extend at least partially through
the button door 102 when the button door 102 is in the closed
position.
[0066] In one embodiment, the distance D1 from the top surface 530
to the contact surface 522 of the power button 500 is greater than
the distance D2 from the top surface 530 to the contact surface 526
of the scroll button 512, or to the contact surface 528 of the
select button 514. In one embodiment, the distance D1 from the top
surface 530 to the contact surface 522 of the power button 500 is
greater than the distance D2 from the top surface 530 to the
contact surface 524 of the memory button 502, or to the contact
surface 525 of the set-up button 504. In one embodiment, the
contact surfaces 524, 525, 526, and 528 of the buttons 502, 504,
512, and 514 are flush with or recessed below the top surface 530,
as illustrated in FIG. 11D.
[0067] Preferably, the power button 500, the scroll button 512, and
the select button 514 comprise a first color and the memory button
502 and the set-up button 504 comprise a second color. More
preferably, the top surface 530 comprises a third color, wherein
the third color contrasts with the first color and the second
color. Preferably, the level of contrast between the first color
and the third color is greater than the level of contrast between
the second color and the third color.
[0068] In one embodiment, the buttons 500, 502, 504, 512, and 514
are all manufactured as a single, unitary, flexible membrane 516 as
illustrated in FIG. 11b. Flexible membrane 516 can comprise any
type of flexible material such as, but not limited to, silicone,
rubber, latex, plastic or any other type of flexible material that
may be used. The flexible membrane 516 is then fitted atop a
contact member 518. Contact member 518 includes a series of
contacts 520 which are positioned underneath the buttons 500, 502,
504, 512, and 514 which are formed on the flexible membrane in 516.
By exerting a pressure upon one of the contacts 520, an electrical
connection can be made. So, for example, by locating the buttons
500, 502, 504, 512, and 514 over the contacts 520 of the contact
member 518, a button 500, 502, 504, 512, and 514 can be engaged by
applying pressure on the contact surface 522, 524, 525, 526, 528 of
the button 500, 502, 504, 512, and 514, thus causing the button
500, 502, 504, 512, and 514 to move downwards and exert pressure on
the contact 520. Once pressure is exerted on the contact 520, the
contact 520 causes an electrical connection to be made and the
button 500, 502, 504, 512, and 514 to be engaged. While the
above-described buttons 500, 502, 504, 512, and 514 use a flexible
membrane 516 and a contact member 518, the button 500, 502, 504,
512, and 514 can be manufactured in any one of a number of
ways.
[0069] In one embodiment, a label 103 is placed onto or connected
with the button door 102. The label 103 describes the function of
each of the buttons 500, 502, 504, 512, and 514 and contains
information explaining each button's 500, 502, 504, 512, and 514
functions in the user's language. Preferably, the label 103 would
be selected and applied by the user from a sheet (not shown)
containing multiple labels 103, each printed in a single
language.
[0070] While the above-described buttons 500, 502, 504, 512, and
514 are arranged in a certain fashion, the buttons may be arranged
in any fashion. Additionally, while the above-described invention
pertains to a sensor dispensing instrument 10 that dispenses
multiple sensors 302, the invention could also be applied to a
testing instrument that does not dispense sensor 302, but rather is
designed to only receive sensors 302.
[0071] As best seen in FIGS. 1, 5 and 11A, a button door 102 is
pivotally connected to the upper case 18 by a pair of pins 104
projecting outwardly from either side of the button door 102 that
engage holes 106 on the side walls of the upper case 18. The button
door 102 also comprises a pair of ears 108 that fit into recesses
110 in the side walls of the upper case 18 when the button door 102
is closed. The ears 108 extend slightly beyond the side walls of
the upper case 18 so that they can be grasped by the user to open
the button door 102. A pivot edge 112 of the button door 102
engages a tab 114 on the upper surface of the upper case 18. The
tab 114 rubs against the pivot edge 112 in such a manner so as to
bias the button door 102 in either a closed or fully open position.
In the preferred embodiment shown, the button door 102 has an
opening 116 that permits one of the buttons 96 (e.g., the power
button 500) to be accessed when the button door 102 is closed (see
FIG. 1). This permits dedicated, but seldom or lesser used buttons
96 to be concealed underneath the button door 102, thereby
simplifying the learning curve and daily operation of the sensor
dispensing instrument 10 for the user.
[0072] The upper case 18 also contains an opening 118 for the
button release 66, which projects upwardly through the upper case
18. As will be described in more detail below, the button release
66 is depressed to disengage the sensor actuator 40 and release a
sensor 302 from the testing position.
[0073] The upper case 18 also contains an opening 120 for a battery
tray assembly 122. The battery tray assembly 122 includes a battery
tray 124 in which a battery 126 is disposed. The batter tray
assembly 122 is inserted into the opening 120 in the side of the
upper case 18. When so inserted, the battery 126 engages battery
contacts 128 and 130 on the circuit board assembly 42 so as to
provide power for the electronics within the instrument 10,
including the circuitry on the circuit board assembly 42 and the
liquid crystal display 64, and the power for the motor 400. A tab
132 on the lower case 24 is configured to engage a slot 134 in the
battery tray assembly 122 so as to prevent the battery tray
assembly 122 from being removed from the sensor dispensing
instrument 10 when the upper case 18 and the lower case 24 are in
the closed configuration.
[0074] An electronics assembly 62 is affixed to the upper inside
surface of the upper case 18. As best seen in FIGS. 16-18, the
electronics assembly 62 comprises a circuit board assembly 42 on
which various electronics and electrical components are attached. A
positive battery contact 128 and a negative battery contact 130 are
disposed on the bottom surface 136 (which is the upwardly facing
surface as viewed in FIGS. 16 and 18) of the circuit board assembly
42. The battery contacts 128 and 130 are configure to electrically
connect with the battery 126 when the battery tray assembly 122 is
inserted into the side of the upper case 18. The bottom surface 136
of the circuit board assembly 42 also includes a communication
interface 138. The communication interface 138 permits the transfer
of testing or calibration information between the sensor dispensing
instrument 10 and another device, such as a personal computer,
through standard cable connectors (not shown). In the preferred
embodiment shown, the communication interface 138 is a standard
serial connector. However, the communication interface 138 could
alternatively be an infra-red emitter/detector port, a telephone
jack, or radio frequency transmitter/receiver port. Other
electronics and electrical devices, such as memory chips for
storing glucose test results or ROM chips for carrying out
programs, are likewise included on the bottom surface 136 and the
upper surface 140 of the circuit board assembly 42.
[0075] A liquid crystal display 64 is affixed to the upper surface
140 (upwardly facing surface in FIG. 17) of the circuit board
assembly 42. The liquid crystal display 64 is held by a snap-in
display frame 142. The snap-in display frame 142 includes side
walls 144 that surround and position the liquid crystal display 64.
An overhang 146 on two of the side walls 144 holds the liquid
crystal display 64 in the snap-in display frame 142. The snap-in
display frame 142 includes a plurality of snap fasteners 148 that
are configured to engage mating holes 150 on the circuit board
assembly 42. The liquid crystal display 64 is electrically
connected to the electronics on the circuit board assembly 42 by a
pair of elastomeric connectors 94 disposed in slots 152 in the
snap-in display holder 142. The elastomeric connectors 94 generally
comprise alternating layers of flexible conductive and insulating
materials so as to create a somewhat flexible electrical connector.
In the preferred embodiment shown, the slots 152 contain a
plurality of slot bumps 154 that engage the sides of the
elastomeric connectors 94 to prevent them from falling out of the
slots 152 during assembly.
[0076] As set forth in detail in U.S. Provisional Patent
Application No. 60/311,944 filed on Aug. 13, 2001, and entitled
"Snap-in Display Frame," MSE#2639, which is hereby incorporated by
reference herein, the snap-in display frame 142 eliminates the
screw-type fasteners and metal compression frames that are
typically used to assemble and attach a liquid crystal display 64
to an electronic device. In addition, the snap-in display frame 142
also permits the liquid crystal display 64 to be tested prior to
assembling the liquid crystal display 64 to the circuit board
assembly 42, and testing of the electronics module 62 prior to
assembly into instrument 10.
[0077] The button set 98 also mates to the upper surface 140 of the
circuit board assembly 42. As mentioned above, the button set 98
comprises several individual buttons 96 that are depressed to
operate the electronics of the sensor dispensing instrument 10. For
example, the buttons 96 can be depressed to activate the testing
procedure of the sensor dispensing instrument 10. The buttons 96
can also be depressed to recall and have displayed on the liquid
crystal display 64 the results of prior testing procedures. The
buttons 96 can also be used to set and display date and time
information, and to activate reminder alarms which remind the user
to conduct a blood glucose test according to a predetermined
schedule. The buttons 96 can also be used to activate certain
calibration procedures for the sensor dispensing instrument 10.
[0078] The electronics assembly 62 further comprises a pair of
surface contacts 139 on the bottom surface 136 of the circuit board
assembly 42 (see FIGS. 16 and 18). The surface contacts 139 are
configured so as to be contacted by one or more fingers 143 on the
cover mechanism 188, which in turn are configured to be engaged by
one or more ramp contacts 141 on the disk drive pusher 48 (see FIG.
13). Movement of the disk drive pusher 48 causes the ramp contacts
141 to push the fingers 143 into contact with one or both of the
surface contacts 139 so as to communicate the position of the
pusher 48 to the electronics assembly 62. In particular, movement
of the pusher 48 from a stand-by or testing positions to an
extended position will turn the sensor dispensing instrument ON. In
addition, if the housing 12 is opened while the pusher 48 is in the
extended position, an alarm will be activated to warn the user that
the knife blade 36 may be in the extended position.
[0079] It should be noted that the design and configuration of the
electronics assembly 62 permits the assembly and testing of the
electronics and electrical components prior to assembly of the
electronics assembly 62 to the upper case 18 of the sensor
dispensing instrument 10. In particular, the liquid crystal display
64, the button set 98, the battery contacts 128 and 130, and the
other electronics and electrical components can each be assembled
to the circuit board assembly 42 and tested to verify that these
components, and the electrical connections to these components, are
working properly. Any problem or malfunction identified by the
testing can then be corrected, or the malfunctioning component can
be discarded, prior to assembling the electronics assembly 62 to
the upper case 18 of the sensor dispensing instrument 10.
[0080] As mentioned above, the sensor dispensing instrument 10
includes calibration circuitry for determining calibration and
production information about the sensor pack 300. As best seen in
FIG. 12, the calibration circuitry comprises a flex circuit 156
located in the lower case 24. The flex circuit 156 is held in
position in the lower case 24 by an autocal disk 158 that is
connected to the rear section 28 of the lower case 24 by a pair of
pins 160. The autocal disk 158 has a raised central portion 162
configured to engage the sensor cavities 304 on the sensor pack 300
so as to hold the sensor pack 300 against the indexing disk 30. The
autocal disk 158 also has an open area 164 located between the pins
160 to expose contacts 166 on the flex circuit 156.
[0081] The flex circuit 156 comprises a plurality of probes 168
that extend upwardly from the flex circuit 156 through holes 170 in
the inner region of the autocal disk 158. These probes 168 are
connected to the contacts 166 on the end of the flex circuit 156.
When the sensor dispensing instrument 10 is closed with the lower
case 24 latched to the upper case 18, the probes 168 make contact
with a conductive label 326 on the sensor pack 300 being used in
the sensor dispensing instrument 10. A foam pad 172 is positioned
below the flex circuit 156 to provide a biasing force to assure
that the probes 168 press against the conductive label 326 with a
force sufficient to make an electrical connection. The foam pad 172
also provides a cushioning force so that the probes 168 can move
independently with respect to each other as the sensor pack 300 is
being rotated by the indexing disk 30. As a result, information,
such as calibration and production data, contained on the
conductive label 326 can be transmitted via the probes 168 to the
flex circuit 156, which in turn couples the data to the electronic
circuitry on the circuit board assembly 42 via an elastomeric
connector 174. This information can then be used by the electronics
assembly 62 to calibrate the sensor dispensing instrument 10, or
can be displayed on the liquid crystal display 64.
[0082] As best seen in FIG. 10, the elastomeric connector 174 is
made of layers of silicon rubber extending from a top edge 176 to a
bottom edge 178 with alternate layers having conductive materials
dispersed therein to connect contacts on the top edge 176 to
contacts on the bottom edge 178. When the upper case 18 and the
lower case 24 are closed, the elastomeric connector 174 is
compressed in the direction between the edges 176 and 178 such that
the contacts along the top edge 176 engage electronic circuitry on
the circuit board assembly 42 in the upper case 18, and the
contacts along the bottom edge 178 engage the contacts 166 on the
flex circuit 156 in the lower case 24. With the elastomeric
connector 174 so compressed, low voltage signals can be readily
transmitted between the circuit board assembly 42 and the flex
circuit 156 through the elastomeric connector 174.
[0083] The elastomeric connector 174 is held in position by a
slotted housing 180 on the guide block 182. In the preferred
embodiment shown, the slotted housing 180 has a serpentine
cross-section configured to allow the connector 174 to compress
when the upper case 18 and the lower case 24 are closed, while
still holding the elastomeric connector 174 when the upper case 18
and the lower case 24 are open. Alternatively, the slotted housing
180 may include inwardly projecting ridges that engage the sides of
the connector 174.
[0084] The disk drive mechanism 34 is affixed to the upper inside
surface of the upper case 18. As best seen in FIG. 10, the disk
drive mechanism 34 is attached to the upper case by a plurality of
mounting screws 184 that engage posts (not shown) on the upper
inside surface of the upper case 18. The mounting screws 184 also
pass through and secure the electronics assembly 62, which is
disposed between the disk drive mechanism 34 and the upper case
18.
[0085] Although the disk drive mechanism 34 will be described in
greater detail below, it should be noted that preferably the disk
drive mechanism 34 is configured so as to permit the assembly and
testing of its operation prior to mounting the disk drive mechanism
34 to the upper inside surface of the upper case 18. In other
words, preferably the disk drive mechanism 34 has a modular design
that can be tested prior to final assembly of the sensor dispensing
instrument 10.
[0086] As best seen in FIGS. 13 and 14A, the disk drive mechanism
34 comprises a guide block 182, a sensor actuator 40, a housing
guide 186, a disk drive pusher 48, an indexing disk drive arm 50, a
knife blade assembly 58, a cover mechanism 188, and a button
release 66. The housing guide 186 is fixed to the upper surface 190
(as viewed in FIG. 13) of the guide block 182 by one or more pins
192. The disk drive pusher 48 is supported on the housing guide 186
and the guide block 182 in such a manner as to permit the disk
drive pusher 48 to slide laterally relative to the housing guide
186 and the guide block 182. The knife blade assembly 58 is
pivotally connected to the underside of the disk drive pusher 48,
and is guided by the housing guide 186 and the guide block 182. The
indexing disk drive arm 50 is also connected to the disk drive
pusher 48, and is partially guided by the guide block 182. The
cover mechanism 188 is affixed to the guide block 182 with the disk
drive pusher 48 and the housing guide 186 disposed therebetween.
The sensor actuator 40 is attached to the guide block 182 and is
engaged by the front end 204 of the disk drive pusher 48 when the
disk drive pusher 48 is in the testing position. The button release
66 is slidably connected to the cover mechanism 188 so as to engage
the front end 204 of the disk drive pusher 48 when the disk drive
pusher 48 is in the testing position.
[0087] As best seen in FIGS. 13, 14A, 14B, and 14C the motor 400,
the linear drive system 410, and the power transfer system 420
allow the disk drive mechanism 34 to automatically load a sensor
302 into a testing position on the front end 14 of the housing 12
once the button 32 is pressed, as described below. Preferably, the
motor 400 is an electrical motor, such as a DC motor, however, the
motor 400 may be any device known to those skilled in the art which
can provide either linear or rotational movement. The motor 400 is
activated once the button 32 is pressed. Button 32 is
electronically connected with motor 400 and may be placed anywhere
on the housing 12. A control unit (not shown) controls the speed
and direction of the motor 400. The motor 400 provides rotational
movement by rotating a shaft 402, as illustrated in FIGS. 14B and
14C. Preferably, the control unit (not shown) controls the speed
and direction of the shaft 402. The motor 400 is attached to the
power transfer system 420 (as viewed in FIGS. 14B and 14C). In one
embodiment the shaft 402 of the motor 400 is connected with the
power transfer system 420. The power transfer system 420 is
connected with the motor 400 and the linear drive system 410. The
power transfer system 420 transfers the power provided by the motor
to the linear drive system 410 and translates the linear or
rotational movement provided by the motor 400 into linear movement
for the linear drive system, as illustrated in FIGS. 14B and 14C.
The linear drive system 410 is connected with the disk drive
mechanism 34 and the power transfer system 420, wherein the linear
drive system 410 moves the disk drive mechanism 34 when the motor
400 is activated. Preferably, the linear drive system 410 is
connected with the pusher 48 of the disk drive mechanism 34 and
moves the pusher 48 when the motor 400 is activated.
[0088] In one embodiment, the power transfer system 420 includes at
least one gear 422 for transferring power and translating movement
from the motor 400 to the linear drive system 410, as illustrated
in FIG. 14B. Preferably, a series of gears 422 are used to transfer
power and translate movement from the motor 400 to the linear drive
system 410, as illustrated in FIG. 148. The linear drive system 410
includes a lead screw 412 and a nut 414 threaded on the lead screw
412, wherein the nut 414 is connected with and moves the disk drive
pusher 48 as the lead screw 412 is rotated. In one embodiment, the
lead screw 412 is a double helix screw, which allows the lead screw
and the motor to rotate in only one direction instead of two, in
order to move the disk drive pusher 48 from the standby position to
the extended position, and from the extended position to the
testing position. The lead screw is connected to the gears 422
through a lead screw connector 426, as illustrated in FIG. 14B.
Preferably, at least one gear 422 is connected with shaft 402,
while a second gear 422 is connected with the lead screw connector
426, as illustrated in FIG. 14B.
[0089] In one embodiment, the power transfer system 420 includes at
least one roller 424 for transferring power and translating
movement from the motor 400 to the linear drive system 410, as
illustrated in FIG. 14C. The roller 424 is connected with the shaft
402. The linear drive system 410 includes a belt 416 and a
connecting member 418 connected to the belt. The belt 416 is
wrapped around the roller 424, as illustrated in FIG. 14C. As the
motor 400 is activated, the roller 424 rotates, causing the belt
416 to move. The connecting member 418 is connected with the disk
drive pusher 48. Therefore, as the belt 416 moves, the disk drive
pusher 48 moves as well.
[0090] An indexing disk 30 is rotatably secured to the disk drive
mechanism 34 by a retainer disk 206 connected through the indexing
disk 30 and into guide block 182. As best seen in FIG. 14A, the
retainer disk 206 has a pair of latch arms 208 that extend through
a central hole 210 in the indexing disk 30 and latch into an
opening 212 in the guide block 182. As mentioned above, the
indexing disk 30 includes a plurality of pins 44 protruding from
the lower surface 214 thereof. These pins 44 are configured to
engage notches 324 on the sensor pack 300 (see FIG. 4) so as to
align and rotate the sensor pack 300 in accordance with the
position of the indexing disk 30. Hence, the pins 44 and the
notches 324 have the dual purpose of retaining the sensor pack 300
on the indexing disk 30 so that the sensor pack 300 will rotate
with the indexing disk 30 and of positioning the sensor pack 300 in
proper circumferential alignment relative to the indexing disk
30.
[0091] As previously indicated, the disk drive pusher 48 is moved
towards the rear end 16 of the housing 12 (away from the testing
end 14) by motor 400 when the button 32 is pressed. The disk drive
pusher 48 is guided in a lateral direction by the guide block 182,
the housing guide 186, and the cover mechanism 188, as the pusher
48 is moved towards the rear end 22 of the upper case 18. As the
disk drive pusher 48 slides towards the rear end 22 on the upper
case 18, the indexing disk drive arm 50 causes the indexing disk 30
to rotate.
[0092] The indexing disk drive arm 50 extends rearwardly from the
disk drive pusher 48. The indexing disk drive arm 50 includes a
plate spring 54 made of spring type material such as stainless
steel so as to bias the arm 50 outwardly from the disk drive pusher
48. A cam button 52 is affixed to the distal end of the arm 50, and
is configured to engage the upper surface 216 (as viewed in FIG.
13) of the indexing disk 30. In particular, the indexing disk drive
arm 50 is bent so as to protrude downwardly through a slot 218 in
the guide block 182 such that the cam button 52 projects outwardly
from the surface thereof. The slot 218 is designed such that the
indexing disk drive arm 50 and the cam button 52 can move along the
slot 218 as the disk drive pusher 48 is moved back and forth during
the testing procedure. The slot 218 also prevents the indexing disk
drive arm 50 from moving sideways with respect to the disk drive
pusher 48 (i.e., it provides lateral support to the indexing disk
drive arm 50).
[0093] As best seen in FIG. 13, the upper surface 216 of the
indexing disk 30 comprises a series of radially extending grooves
60 and a plurality of curvilinearly extending grooves 56. The cam
button 52 is configured to ride along these grooves 56 and 60
during the movement of the disk drive pusher 48. As the disk drive
pusher 48 slides towards the rear end 22 of the upper case 18, the
cam button 52 moves along one of the curvilinearly extending
grooves 56. This causes the indexing disk 30 to rotate. In the
preferred embodiment shown, there are ten radially extending
grooves 60 and ten curvilinearly extending grooves 56 equally
spaced about the circumference of the indexing disk 30, with each
radially extending groove 60 being disposed between a pair of
curvilinearly extending grooves 56. Accordingly, the movement of
the disk drive pusher 48 towards the rear end 22 on the upper case
18 results in a 1/10.sup.th rotation of the indexing disk 30. As
the button 32 is pressed, and the pusher 48 is moved towards the
rear end 16 of the housing 12, the cam button 52 passes over an
outer step 220 that separates the outer end 222 of the
curvilinearly extending groove 56 from the adjacent radially
extending groove 60. The outer step 220 is formed by the difference
in depth between the outer end 222 of the curvilinearly extending
groove 56 and the outer end 224 of the adjacent radially extending
groove 60. In particular, the outer end 224 of the radially
extending groove 60 is deeper than the outer end 222 of the
curvilinearly extending groove 56. Thus, when the cam button 52
moves from the curvilinearly extending groove 56 into the adjacent
radially extending groove 60, the biasing force of the plate spring
54 of the indexing disk drive arm 50 causes the cam button 52 to
travel downwardly past the outer step 220. The outer step 220
prevents the cam button 52 from re-entering the outer end 222 of
the curvilinearly extending groove 56 when the direction of travel
of the disk drive pusher 48 is reversed (as will be explained
below).
[0094] Rotation of the indexing disk 30 causes the sensor pack 300
to likewise rotate so that the next available sensor cavity 304 is
placed in a standby position adjacent to the testing end 14 of the
housing 12. The sensor pack 300 rotates with the indexing disk 30
because of the engagement of the notches 324 on the sensor pack 300
by the pins 44 on the indexing disk 30. As explained above, each
sensor cavity 304 contains a disposable sensor 302 that is used
during the glucose testing procedure.
[0095] Further rearward movement of the disk drive pusher 48 is
prevented by a rear wall 226 on the guide block 182. In the
preferred embodiment shown, the rear wall 226 includes a slotted
housing 180 for holding the elastomeric connector 174 that connects
the electronics assembly 62 to the flex circuit 156 disposed in the
lower case 24. An interior edge 228 of the disk drive pusher 48
engages the rear wall 226 on the guide block 182 when the disk
drive pusher 48 is in the fully extended position.
[0096] Upon reaching the rear end 16 of the housing 12, the pusher
48 then changes direction and moves inwardly back past the standby
position (FIG. 1) and into a testing position (FIG. 7). As
previously indicated, the inward movement of the pusher 48 causes
the disk drive mechanism 34 to remove a sensor 302 from the sensor
pack 300 and place the sensor 302 into a testing position.
[0097] As best seen in FIGS. 13 and 14A, the disk drive mechanism
34 includes a knife blade assembly 58 that is pivotally mounted to
the disk drive pusher 48. The knife blade assembly 58 comprises a
swing arm 230 having a first end 232 that is pivotally connected to
the disk drive pusher 48 by a pair of pivot pins 234. A knife blade
36 is connected to the second end 236 of the swing arm 230. The
second end 236 of the swing arm 230 also includes a first cam
follower 238 and a second cam follower 240, each in the shape of a
transversely extending post. The first cam follower 238 is
configured to follow a pathway formed on one side of the knife
blade assembly 58 by the guide block 182, the housing guide 186,
and the cover mechanism 188. In particular, this pathway is formed
by a cam projection 242 on the housing guide 186 that forms an
upper pathway 244 between the cam projection 242 and the cover
mechanism 188 and a lower pathway 246 between the cam projection
242 and the guide block 182. When the first cam follower 238 is
disposed in the upper pathway 244, the knife blade 36 is in the
retracted position. On the other hand, when the first cam follower
238 is disposed in the lower pathway 246, then the knife blade 36
is in the extended position. The upper pathway 244 and the lower
pathway 246 are connected together at both ends of the cam
projection 242 so as to form a continuous loop about which the
first cam follower 238 can travel.
[0098] The second cam follower 240 engages a cam spring 248
attached to the housing guide 186. As will be explained below, the
cam spring 248 guides the knife blade assembly 58 from the lower
pathway 246 to the upper pathway 244 when the disk drive pusher 48
is initially moved rearward from standby position towards the
extended position. The disk drive pusher 48 also comprises a spring
250 for biasing the knife blade 36 towards the extended position
when the disk drive pusher 48 is initially moved forward from the
extended position towards the testing position. In the preferred
embodiment shown, the spring 250 comprises a plate spring that
presses against the upper side of the swing arm 230.
[0099] As the button 32 is pressed, the disk drive pusher 48 is
moved laterally towards the testing or front end 14 of the housing
12. As the disk drive pusher 48 begins to move forward, the spring
250 biases the swing arm 230 downwardly towards the indexing disk
30 so that the first cam follower 238 engages a sloped surface 252
on the interior end 268 of the cam projection 242 and is forced
into the lower pathway 246. This causes the knife blade 36 to
assume an extended position whereby the knife blade 36 projects
outwardly through a knife slot 46 in the indexing disk 30 to pierce
the protective foil 310 covering one of the sensor cavities 304 and
engage the notch 312 on the back end 308 of the sensor 302
contained therein. As the disk drive pusher 48 continues to move
towards the front end 20 of the upper case 18, the first cam
follower 238 continues along the lower pathway 246, thereby causing
the knife blade 36 to remain in the extended position projecting
through the knife slot 46 so that it will travel along the knife
slot 46 and push the sensor 302 forward out of the sensor cavity
304 and into a testing position at the front end 14 of the housing
12. The sensor 302 is in the testing position when the front end
306 of the sensor 302 projects out of the sensor opening 254 formed
on the front end of the guide block 182. While in the testing
position, the sensor 302 is prevented from being pushed back
through the sensor opening 254 by the engagement of the knife blade
36 against the notch 312 on the back end 308 of the sensor 302.
[0100] As the disk drive pusher 48 reaches the testing position,
the front end 204 of the disk drive pusher 48 simultaneously
engages the sensor actuator 40 and the button release 66. In
particular, the front end 204 of the disk drive pusher 48 engages
and pushes the button release 66 outwardly so as to project
upwardly from the upper surface of the upper case 18. At the same
time, the front end 204 of the disk drive pusher 48 engages a
contact pad 256 on the sensor actuator 40 so as to force the sensor
actuator 40 downward. This downward motion causes a pair of metal
contacts 38 on the sensor actuator 40 to project into the sensor
opening 254 on the guide block 182 and engage the contacts 314 on
the sensor 302 for the glucose testing procedure. The metal
contacts 38 also apply a frictional force to the sensor 302 so that
the sensor 302 does not prematurely fall out of the sensor opening
254 prior to completion of the glucose testing procedure. In the
preferred embodiment shown, the metal contacts 38 are somewhat
flexible and are made of stainless steel. The housing guide 186
includes support ribs 187 disposed adjacent to the metal contacts
38 so as to prevent the metal contacts 38 from bending. As
explained above, the metal contacts 38 permit the transmission of
electrical signals between the sensor 302 and the electronics
assembly 62 during the glucose testing procedure.
[0101] When the glucose testing procedure is complete, the button
release 66 is depressed to release the sensor 302 from the testing
position. The button release 66 has a sloped contact surface 258
that engages the front end 204 of the disk drive pusher 48 at an
angle. As the button release 66 is depressed, the sloped contact
surface 258 slides along the front end 204 of the disk drive pusher
48, thereby causing the disk drive pusher 48 to move rearward from
the testing position and into the standby position. In the
preferred embodiment shown, the disk drive pusher 48 is moved
laterally a distance of 0.080 inches. The movement of the disk
drive pusher 48 to the standby position also causes the front end
204 of the disk drive pusher 48 to disengage from the contact pad
256 on the sensor actuator 40, thereby allowing the sensor actuator
40 to move away from and disengage the sensor 302. The sensor 302
can then be removed by tipping the front end 14 of the sensor
dispensing instrument 10 downwardly.
[0102] As mentioned above, when the disk drive pusher 48 is pushed
from the extended position towards the testing position, the cam
button 52 on the indexing disk drive arm 50 travels along one of
the radially extending grooves 60 to prevent the indexing disk 30
and the sensor pack 300 from rotating. The radially extending
groove 60 includes a sloped portion 260 that changes the depth of
the groove 60. In particular, the sloped portion 260 decreases the
depth of the radially extending groove 60 so that the middle
portion of the radially extending groove 60 is shallower than the
curvilinearly extending grooves 56. The radially extending groove
60 also comprises an inner step 262 near its inner end 264 (i.e.,
near the center of the indexing disk 30). The inner step 262 is
formed along the juncture of the inner end 264 of the radially
extending groove 60 and the inner end 266 of the curvilinearly
extending groove 56. As the disk drive pusher 48 is pushed from the
extended position towards the testing position, the cam button 52
travels up the sloped portion 260 of the radially extending groove
60, past the inner step 262, and into the adjacent curvilinearly
extending groove 56. The biasing force of the plate spring 54 of
the indexing disk drive arm 50 causes the cam button 52 to travel
downwardly past the inner step 262. The inner step 262 prevents the
cam button 52 from re-entering the radially extending groove 60
when the direction of travel of the disk drive pusher 48 is
reversed (as explained above in connection with the outward
movement of the disk drive pusher 48).
[0103] As the disk drive pusher 48 reaches the testing position,
the first cam follower 238 passes the exterior end 270 of the cam
projection 242. At the same time, the second cam follower 240
passes over the end of the cam spring 248, which retracts upwardly
and out of the way as the first cam follower 238 nears the exterior
end 270 of the cam projection 242. Once the first cam follower 238
has passed the end of the cam spring 248, the cam spring 248 moves
downwardly so as to engage and guide the second cam follower 240
upwardly when the direction of travel of the disk drive pusher 48
is reversed and pulled outward towards the extended position. In
particular, when the disk drive pusher 48 is subsequently moved
into the extended position, the cam spring 248 guides the second
cam follower 240 upwardly so that the first cam follower 238 enters
the upper pathway 244 and the knife blade 36 is retracted.
[0104] As explained above, the disk drive pusher 48 is moved
outwardly to initiate the testing procedure. During the outward
motion of the disk drive pusher 48, the cam button 52 on the
indexing disk drive arm 50 travels along one of the curvilinearly
extending grooves 56 so as to rotate the indexing disk 30. During
this outward motion, the first cam follower 238 on the knife blade
assembly 58 travels along the upper pathway 244. As a result, the
knife blade 36 is retracted from the knife slot 46 on the indexing
disk 30 so that the indexing disk 30 is free to rotate in response
to action of the cam button 52 in the curvilinearly extending
groove 56. As the disk drive pusher 48 reaches the fully extended
position, the first cam follower 238 passes the interior end 268 of
the cam projection 242 and is guided into the lower pathway 246 by
the biasing force of the spring 250 on the swing arm 230 of the
knife blade assembly 58.
[0105] Prior to operating the sensor dispensing instrument 10, a
sensor pack 300 must first be loaded into the sensor dispensing
instrument 10 if one has not already been so loaded, or if all of
the sensors 302 in the previously loaded sensor pack 300 have been
used. To load a sensor pack 300, the lower case 24 and the upper
case 18 are opened by depressing the latch 72 on the lower case 24.
In the preferred embodiment shown, the opening of the lower case 24
and the upper case 18 causes the elastomeric connector 174 to
separate from the contacts 166 on the flex circuit 156, thereby
breaking the electrical connection between the flex circuit 156 and
the electronics assembly 62. This causes an electronic counter
(which is part of the electronics assembly 62) that keeps count of
the number of unused sensors 302 in the sensor pack 300 to re-set
to zero (0).
[0106] The opened housing 12 is then turned so that the lower
surface 214 of the indexing disk 30 faces upwardly as shown in FIG.
3. A sensor pack 300 is then placed on the indexing disk 30 by
aligning the notches 324 along the periphery of the sensor pack 300
with the pins 44 on the indexing disk 30. The lower case 24 is then
pivoted on to the upper case 18 so as to enclose the sensor pack
300 within the housing 12. Once the lower case 24 is secured to the
upper case 18 by the latch 72, the sensor dispensing instrument 10
is ready for operation.
[0107] The following is a brief description of the operation of the
sensor dispensing instrument 10. First, the button 32 is pressed
which causes the sensor dispensing instrument 10 to turn ON and the
cam button 52 on the indexing disk drive arm 50 to travel along one
of the curvilinearly extending grooves 56 on the upper surface 216
of the indexing disk 30 so as to rotate the indexing disk 30
1/10.sup.th of a complete rotation. The rotation of the indexing
disk 30 causes the sensor pack 300 to be rotated so that the next
one of the sensor cavities 304 is placed in a standby position
aligned with the testing end 14 of the housing 12. At the same
time, the knife blade assembly 58 is retracted and moved towards
the center of the indexing disk 30.
[0108] Next, the pusher 48 moves away from the rear end 16 of the
housing 12 causing the knife blade assembly 58 to pivot downwardly
so that a knife blade 36 pierces a portion of the protective foil
310 covering the sensor cavity 304 in the standby position and
engages the sensor 302 in the sensor cavity 304. As the pusher 48
continues to move away from the rear end 16 of the housing 12, the
knife blade assembly 58 forces the sensor 302 out of the sensor
cavity 304 and into a testing position at the front end 14 of the
housing 12. At the same time, the cam button 52 on the indexing
disk drive arm 50 travels along one of the radially extending
grooves 60 to prevent the indexing disk 30 from rotating.
[0109] After the sensor 302 has been completely ejected from the
sensor cavity 304 and pushed into a testing position projecting out
from the front end 14 of the housing 12, the sensor actuator 40
engages the sensor 302 to hold the sensor 302 in the testing
position and to couple the sensor 302 to the electronics assembly
62. The front end 306 of the sensor is then inserted into a drop of
blood to be tested, whereby the blood is analyzed by the
electronics assembly 62. The results of the analysis are then
displayed on the liquid crystal display 64 of the sensor dispensing
instrument 10.
[0110] Once the analysis of the blood is complete, the button
release 66 on the upper case 18 is depressed so as to disengage the
sensor actuator 40 and release the sensor 302, which can be
disposed of by tipping the front end 14 of the housing 12
downwardly.
[0111] While the invention has been described with reference to
details of the illustrated embodiment, these details are not
intended to limit the scope of the invention as defined in the
appended claims. For example, the sensor dispensing instrument 10
can be used for testing fluids other than blood glucose. In fact,
the sensor dispensing instrument 10 can be used in connection with
the analysis of any type of chemistry fluid that can be analyzed by
means of a reagent material.
* * * * *