Note: Descriptions are shown in the official language in which they were submitted.
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
CONTROLLED INVENTORY REFRIGERATED DISPENSING SYSTEM
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
This invention relates generally to refrigerated product storage and
dispensing, and
more particularly to a refrigeration system for storing products (such as
pharmaceutical
products) and dispensing such products in a controlled manner that allows
automatic tracking
of inventory dispensed by and maintained within the refrigerated dispensing
unit.
BACKGROUND
Pharmaceutical products are distributed in many different ways. In many
instances,
the pharmaceutical product must be kept at a specific temperature in order to
ensure its active
ingredients retain their chemical properties. For example, some vaccines and
antibiotics must
be kept refrigerated to ensure that they maintain their pharmaceutical
capabilities. In
dispensaries, whether pharmacies or doctor's offices, these drug products are
typically kept in
traditional refrigerators. There is a minimum level of security and
maintaining an inventory
of the products can be a tedious and labor intensive endeavor.
Existing refrigerators and other such containers do not provide a doctor or
pharmacist
with an easy and secure method for dispensing medicines that require
refrigeration. Thus,
there is a need for a refrigerated container that allows physicians,
pharmacists, and other
individuals responsible for dispensing medicine to easily dispense the
products and maintain
an accurate inventory of the products.
Moreover, many systems for dispensing pharmaceutical products are maintained
in a
secure assembly, such as a locked cabinet, to prevent unauthorized access.
However, in the
event that such system is refrigerated, and must maintain its contents in a
refrigerated
condition, upon a loss of power it may become difficult if not impossible to
remove product
to alternative, refrigerated storage. Likewise, for systems that store many
different
1
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
pharmaceutical products, it may be a significantly time-intensive task to
remove each
pharmaceutical product from the dispensing system so as to place it in an
alternative,
refrigerated storage location. Thus, there is a need for a refrigerated
container for
pharmaceutical or other valuable products that allows quick, alternative
access to locked
contents during a loss of power, and that allows easy removal of such contents
in bulk during
such conditions.
Further, varied medical facilities have varying pharmaceutical products stored
on
hand from time to time, and thus have pharmaceutical product storage needs
that may vary
over time. Different pharmaceutical products may be provided in packages of
varying sizes,
such that one dispensing system for such products may not be suitable for all
pharmaceutical
products stored in any given facility. Thus, there is a need for a
pharmaceutical or other
valuable product storage and dispensing system that is adaptable so as to be
able to securely
store and dispense varied products over time.
SUMMARY OF THE INVENTION
The present invention addresses one or more of the problems described above
and
other issues associated with traditional storage of refrigerated products that
require a
controlled inventory. A refrigerated dispensing system is provided including
an outer
refrigerator cabinet and an interior, removable chassis that mounts a
plurality of separately
removable product storage and dispensing cartridges. While individual
cartridges are
removably positionable within slots on one or more shelves inside of the
chassis, the entire
chassis (with cartridges positioned thereon) may be removed from the outer
refrigerator
cabinet, as may be desirable in the event of a loss of power to the outer
refrigerator cabinet.
The shelves are preferably of a modular and reconfigurable design, thus
allowing portions of
the chassis (e.g., individual shelves or portions thereof) to be modified or
replaced with
2
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
alternative shelving or other storage devices to meet the current refrigerated
product storage
needs of any particular facility.
With regard to a particular embodiment, a refrigerated storage and dispensing
unit is
provided, comprising a refrigerator cabinet, a chassis positioned on an
interior of the
refrigerator cabinet having walls defining an open cavity on an interior of
the chassis, a shelf
affixed to the walls of the chassis within the open cavity, and a plurality of
product
dispensing cartridges removably positioned on the shelf, each product
dispensing cartridge
further comprising a vertical housing holding a plurality of product units and
a dispensing
drawer configured for horizontal movement out of the housing, wherein each
product
dispensing cartridge is configured to sequentially dispense a single one of
the product units
upon each horizontal extension of the dispensing drawer from a fully closed
position to a
fully open position.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention and various aspects, features, and advantages provided
by it are
described in detail below with reference to exemplary and non-limiting
embodiments and
with reference to the drawings, which constitute part of this specification
and provide graphic
depictions of certain exemplary embodiments. The following is a brief
description of the
drawings:
FIG. 1 is a front perspective view of a refrigerated storage and dispensing
unit in
accordance with certain aspects of an embodiment of the invention.
FIG. 2 is a block diagram of the control and chilled compai iment.
FIG. 3A is a front perspective view of the refrigerated storage and dispensing
unit of
FIG. 1 with its front door open to provide access to the interior of the unit.
3
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
FIG. 3B is a front perspective view of the refrigerated storage and dispensing
unit of
FIG. 3A with dispensing cartridges positioned on a bottom shelf
FIG. 4 is a front perspective view of an interior chassis for use with the
refrigerated
storage and dispensing unit of FIG. 1.
FIG. 5 is an exploded view of the interior chassis of FIG. 4.
FIG. 6 is a close-up view of a chassis release system for use with the
interior chassis
of FIG. 4.
FIG. 7 is a front view of the chassis of FIG. 4.
FIG. 8 is a perspective view of a combined storage shelf and storage drawer
for use
with the chassis of FIG. 4.
FIG. 9 is a close-up view of the combined storage shelf and storage drawer of
FIG. 8.
FIG. 10 is a front view of the combined storage shelf and storage drawer of
FIG. 8.
FIG. 11 is a perspective view of the combined storage shelf and storage drawer
of
FIG. 4 with the printed circuit board and bottom plate removed for clarity.
FIG. 12 is a perspective view of the combined storage shelf and storage drawer
of
FIG. 11 with only the printed circuit board removed for clarity.
FIG. 13 is a side perspective view of the combined storage shelf and storage
drawer of
FIG. 11.
FIG. 14 is a top perspective view of the combined storage shelf and storage
drawer of
FIG. 11.
FIG. 15 is a rear perspective view of the combined storage shelf and storage
drawer of
FIG. 11.
FIG. 16 is a close-up rear perspective view of the combined storage shelf and
storage
drawer of FIG. 11.
4
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
FIG. 17 is a front perspective view of a dispensing cartridge for use with the
storage
and dispensing unit of FIG. 1.
FIG. 18 is a rear perspective view of the dispensing cartridge of FIG. 17.
FIG. 19 is a cross sectional view of an RFID open-front box for use with the
storage
and dispensing unit of FIG. 1.
FIG. 20 is a rear view of the RFID open-front box of FIG. 19.
FIG. 21 is a block diagram of a freezer compartment for use with the storage
and
dispensing unit of FIG. 1.
FIG. 22 is a schematic diagram of a system in accordance with certain aspects
of
embodiment of the invention.
FIG. 23 is a schematic diagram of a network for implementing the system of
FIG. 22.
FIG. 24 is a flow diagram of a process for dispensing products in accordance
with
further aspects of an embodiment of the invention.
DETAILED DESCRIPTION
The invention summarized above may be better understood by referring to the
following description, which should be read in conjunction with the
accompanying claims
and drawings in which like reference numbers are used for like parts. The
following
description is of a particular embodiment of the invention, set out to enable
one to practice an
implementation of the invention, and is not intended to limit the preferred
embodiment, but to
serve as a particular example thereof Those skilled in the art should
appreciate that they may
readily use the conception and specific embodiments disclosed as a basis for
modifying or
designing other methods and systems for carrying out the same purposes of the
present
invention. Those skilled in the art should also realize that such equivalent
assemblies do not
depart from the spirit and scope of the invention in its broadest form.
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
First, with reference to Figure 1, an exemplary refrigerated storage and
dispensing
unit 100 according to certain aspects of an embodiment of the invention
consists of a
refrigerator cabinet 102 having a door 105 and a control compartment 115,
which control
compartment 115 may include a communication interface configured to
communicate with a
remote server. Refrigerator cabinet 102 may include a chiller (most preferably
ammonia
absorption, but in certain embodiments a compressor will be used).
A system utilizing such refrigerated storage and dispensing unit may be
operated by a
person removing a product from an interior of refrigerator cabinet 102, and
control
compartment 115 recording the removal of product as a transaction in its local
memory on
the control compartment 115. Periodically, the control compartment 115 may use
the
communication interface to send transaction data along with events (e.g.,
historical
temperature data, power outages, events causing alarms, etc.) to a remote
server. The remote
server may then communicate with outside entities for inventory control,
maintenance,
alarms, billing, and any other essential tasks. A refill technician or
specialist may
communicate with the refrigerated storage and dispensing unit 100 using a
display 130 and
keypad 140 on the control compartment 115, or optionally via a web-enabled
device,
BLUETOOTH device, or other remote device to manage the functions and refilling
of the
refrigerated storage and dispensing unit 100.
Preferably, external door 105 is provided an electric or mechanical lock, and
is used
to control access to the products stored in the refrigerated storage and
dispensing unit 100. If
an electric lock is provided, such electric lock is preferably controlled by a
computer
processor in the control compartment 115 after a valid access code is entered
or, as described
more fully below, when specific events occur that require that the door be
locked or
unlocked.
6
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
Control compartment 115 provides a user interface that a pharmacist, doctor,
or other
user may engage to manage the refrigerated storage and dispensing unit 100. In
accordance
with certain aspects of an embodiment of the invention and as noted above,
control
compartment 115 preferably includes a display 130 and a user input device 140.
Display 130
may consist of a LCD, and the user input device may be a key pad. Optionally,
the user input
device 140 and the display 130 may be combined into a touchscreen as will be
recognized by
a person of ordinary skill in the art. The control compartment 115 may also
optionally include
one or more of the following elements: an alarm sounder, a camera for a bar
code reader, a
USB communications interface, an external communications interface (Ethernet,
PLC, POTS,
Cellular, Satellite, WiFi, etc.), and an internal communications interface
(I2C and GPIO) for
communication among the internal components of the refrigerated storage and
dispensing
unit (as discussed in greater detail below), all controlled by a computer
processor.
Control compartment 115 preferably includes the computer processor, memory,
RTC,
battery backup, and necessary interfaces to communicate with all hardware. The
computer
processor may use a Linux OS with an Android OS and application running on it,
although
alternative operating systems may be employed. Figure 2 provides a schematic
diagram of
the electrical connections of an exemplary control compartment 115.
Preferably, all control and communications are managed by control compartment
115.
Users communicate with the vending refrigerator 100 via the user interface,
e.g., keypad 140
and LCD 130, touchscreen, or web or BLUETOOTH enabled device such as a smart
phone,
tablet, laptop, etc. Communications to a server and external users are
accomplished via the
external communications interface. The user interface may be managed through a
mobile
device application to control the screens, touchscreen and keypad. The same
mobile
application or a remote website can be used in a mobile device and, thus, the
user does not
have to be co-located with the refrigerated storage and dispensing unit 100 in
order to affect
7
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
such control. The mobile application or remote website enables any wireless
communication
device to interact with the refrigerated storage and dispensing unit 100 or
the system that
includes the refrigerated storage and dispensing unit 100.
An alarm sounder may be used to signify to local users that a critical event
(e.g., no
power, temperature out of range, etc.) has occurred and that a user is needed
to attend to the
refrigerated storage and dispensing unit 100. The user can mute the alarm,
e.g., via LCD 130
and/or keypad 140. A USB interface preferably provides a maintenance port for
diagnostics
and emergency download of data. It is contemplated that the interface may be
any port, USB
or otherwise, that allows physical electronic access to the internal
components of the
refrigerated storage and dispensing unit 100, e.g., Ethernet port, HDMI, etc.
Such interface
may also be used to setup the refrigerated storage and dispensing unit 100 and
for
manufacturing assistance. A barcode reader, which consists of a camera, camera
interface,
and an application to manage the reader, e.g., a mobile device or wireless
device, can be used
for reading data from the products to be stored in the refrigerated storage
and dispensing unit
100. Typical data may include the kind of product, expiration date and lot
code.
The main power supply is preferably monitored to determine the type of current
being
supplied, e.g., AC or DC, the current voltage, and the current battery status.
The interface is
also used to control the switch between AC and a battery source for testing
the battery and
during loss of AC power. The switch is also used to shed the load of the
chiller if the battery
supply runs low. A backup power supply on the processor board consisting of a
battery or
supercapacitor is used in the event that the main power source is not present.
In the event that
the main power source is not present, software executable by control
compartment 115 will
load the volatile data into non-volatile memory (Flash, MRAM, FRAM, EEPROM,
etc.)
using this backup power supply.
8
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
Internal communications among the components of the refrigerated storage and
dispensing unit 100 (discussed in detail below) may be managed via I2C of
GPIO. The I2C
is preferably used for the main communications for control and status. The
GPIO is
preferably used for real time interrupts and programming.
FIGs. 3a and 3b show door 105 of refrigerator cabinet 102 open to provide
access to
product stored within the refrigerated storage and dispensing unit 100. As
shown in FIG. 3a
and in accordance with certain aspects of an embodiment of the invention, the
refrigerated
storage and dispensing unit may include an interior chassis 300, a top shelf
320, a bottom
shelf 340, and an intermediate drawer assembly 360, all of which are discussed
in greater
detail below. Top shelf 320 and bottom shelf 340 define parallel slots
configured to receive
individual product dispensing cartridges 400 (FIG. 3b), with such product
dispensing
cartridges arranged parallel to one another along their respective shelf More
particularly,
each such product dispensing cartridge 400 holds a plurality of product
containers, such as
vials of injectable pharmaceuticals, syringe packages, or other such packages
as may be
suitable to a particular facility or configuration. Moreover, each such
product dispensing
cartridge 400 includes a dispensing drawer at the base of each cartridge, with
each such
dispensing cartridge 400 being configured to dispense only a single product
container at a
time from its respective dispensing drawer. The product dispensing cartridges
400 are
insertable into slots on shelf 320 and shelf 340. Such slots for top shelf 320
are defined by
guide tabs 322 extending upward from shelf 320 and dividers 324 extending
downward from
an upper divider wall defined by the top wall of chassis 300, and slots for
bottom shelf 340
are defined by guide tabs 342 extending upward from shelf 340 and dividers 344
extending
downward from a lower divider wall defined by the bottom wall of intermediate
drawer
assembly 360. Further and as discussed in detail below, product dispensing
cartridges 400
9
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
may be locked in place on shelf 320 and on shelf 340 with movable latches that
engage the
rear of each product dispensing cartridge 400.
Each of top shelf 320 and bottom shelf 340 preferably includes sensors that
engage
with product dispensing cartridges 400 (shown in FIG. 3b) to detect dispensing
of product
from such dispensers 400. In order to collect such data from top shelf 320 and
bottom shelf
340, a backplane 380 is located at the back of chassis 300, and dispensing
shelves 320 and
340 electronically connect to backplane 380 to transfer data collected by
sensors on
dispensing shelves 320 and 340 to control compartment 115. Backplane 380
buffers the
communication signals between the top shelf 320 and bottom shelf 340 and the
processor of
control compartment 115. Temperature sensors on backplane 380 may provide
temperature
data to the processor of control compartment 115. Controls for a fan and door
locks are
preferably located on backplane 380 and are in communication with the
processor of control
compartment 115. The door sensor logic is preferably stored on backplane 380
for the
processor of control compartment 115 to access. Control logic on backplane 380
may
determine which shelf, device, or freezer interface the processor platform
communicates
with. Power from the main power supply is distributed on backplane 380 for
shelves 320 and
340 and logic. Power is preferably stepped down on backplane 380 for the
processor in
control compartment 115.
As mentioned above, top shelf 320 and bottom shelf 340 receive product
dispensing
cartridges 400, with such product dispensing cartridge sitting on top of a
shelf 320 or 340,
with contacts on the movable dispensing drawer of each product dispensing
cartridge
positioned and otherwise configured to activate the sensors on the shelf
(discussed in greater
detail below). In accordance with certain aspects of an embodiment of the
invention, each of
shelf 320 and 340 has several sensor pads under each product dispensing
cartridge 400. More
particularly, and by way of non-limiting example, each of shelf 320 and 340
may have at
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
least three sensor pads facing upwards in a configuration that allows product
and drawer
sensing as described in more detail below. The sensor pads are connected to a
processor on
the respective shelf 320 or 340, or directly to the processor of control
compartment 115
through backplane 380. The sensors can be, by way of non-limiting example,
capacitive,
infrared, or mechanical. A sensing application running on the processor
detects the presence
or absence of product on that particular sensor, and may also detect the
mechanical position
of different parts of the product dispensing cartridge. This data is sent to
the processor of
control compartment 115 to determine if the product has been removed or if
there is a
malfunction. Data from a digital temperature sensor is also sent to the
processor of control
compartment 115 to be used in controlling a heater/cooler, for historical data
for product
aging, and for alarms.
FIG. 4 provides a perspective view, and FIG. 5 an exploded perspective view,
of
chassis 300 removed from refrigerator cabinet 102 (refrigerator cabinet 102
not shown for
clarity). Circumstances may arise that create a desirability or need to remove
the entire
contents of the refrigerated storage and dispensing system 100, such as in the
event of a long-
term power loss which would require moving all contents to an alternative
refrigerated
storage. To provide for such capability, the entire chassis 300 is removable
from the interior
of refrigerator cabinet 102. A refrigerator cabinet mounting nut 104 is
fixedly mounted to at
least one, and preferably both interior sidewalls of refrigerator cabinet 102.
Chassis 300 has
a horizontal mounting nut slot 302 in preferably both sidewalls of chassis
300, which
mounting nut slot 302 slidably receives refrigerator cabinet mounting nut 104.
As shown in
FIG. 5 and FIG. 6 (in which chassis 300 is shown in phantom), mounting nut 104
serves as
an anchor to releasably hold chassis 300 in refrigerator cabinet 102. A
chassis release bar
304 is pivotably mounted to intermediate drawer assembly 360 at pivot screw
mount 306. As
best viewed in the close-up side perspective view of intermediate drawer
assembly 360 and
11
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
top shelf 320 of FIG. 9, chassis release bar 304 has a notch 308 at a back end
of chassis
release bar 304, which notch 308 receives refrigerator cabinet mounting nut
104. While
chassis release bar 304 is pivotable about pivot screw mount 306, a spring 310
biases chassis
release bar 304 into a position that engages notch 308 with mounting nut 104,
in turn locking
chassis 300 in refrigerator cabinet 102. A handle 312 is provided at the front
end of chassis
release bar 304, which handle 312 may be manually engaged and pushed downward
to pivot
chassis release bar 304 about pivot screw mount 306, disengaging notch 308
from mounting
nut 104, and thus allowing the entire chassis 300 (along with top shelf 320,
bottom shelf 340,
and drawer assembly 360) to be horizontally pulled outward from refrigerator
cabinet 102.
Preferably, a release bar cover plate 314 is removably mounted by, for
example, security
screws to the front face of intermediate drawer assembly 360, allowing an
authorized person
to access handle 312 to disengage chassis release bar 304 from mounting nut
104 and remove
the entire chassis and its contents from the refrigerator cabinet 102.
As mentioned above, top shelf 320, bottom shelf 340, and intermediate drawer
assembly 360 are mounted to chassis 300. FIG. 7 is a front view of chassis 300
with top shelf
320, bottom shelf 340, and intermediate drawer assembly 360 removed for
clarity. Chassis
300 includes a top wall 702, a right side wall 704, and a left side wall 706.
Chassis 300 also
provides a mounting wall 708 for backplane 380. Right side wall 704 and left
side wall 706
include upper support flanges 710 extending into the interior of chassis 300
from each
respective sidewall. Upper support flanges 710 receive and support the bottom
wall of top
shelf 320, such as by way of threaded connectors 712 (FIGs. 8 and 9). Right
side wall 704
and left side wall 706 also include lower support flanges 714 extending into
the interior of
chassis 300 from each respective sidewall. Lower support flanges 714 receive
and support
the bottom wall of intermediate drawer assembly 360, such as by way of
threaded connectors
716. Still further, right side wall 704 and left side wall 706 include bottom
mounting
12
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
brackets 718 extending into the interior of chassis 300 from each respective
sidewall. As
with upper support flanges 710, bottom mounting brackets 718 receive and
support the
bottom wall of bottom shelf 342, such as by way of threaded connectors.
Such support configuration allows replacement of any of top shelf 320, bottom
shelf
340, or intermediate drawer assembly 360 with minimal effort, as may be
desirable to meet
changing refrigerated product storage needs. By way of non-limiting example, a
given
facility may wish to dedicate only bottom shelf 340 to receiving cartridges
400, and may wish
to provide alternative storage space in the top portion of chassis 300. In
this case, top shelf
320 may be removed from chassis 300 by removing threaded connectors 712, and
such
alternative storage assembly as may be selected by persons skilled in the art
may be affixed in
its place. In certain configurations, an open-front storage box equipped with
a radio
frequency identification ("RFID") antenna may be put in the place of top shelf
320 and
attached to upper support flanges 710, or positioned directly on top shelf 320
or a portion
thereof (such as to bottom plate 326 of top shelf 320, discussed below), which
may receive
and store RFID tagged product containers, as discussed in greater detail
below.
With continued reference to FIGs. 7 and 8, top shelf 320 includes a flat panel
321 that
serves as the support for product dispensing cartridges 400. In certain
configurations, flat
panel 321 comprises a printed circuit board. Guide tabs 322 are positioned
adjacent a front
edge of flat panel 321 and serve to properly position product dispensing
cartridges 400 as
they are being placed on top shelf 320. To further assist in properly
positioning product
dispensing cartridges, rear guide posts 325 are likewise provided and
positioned in alignment
with guide tabs 322, thus defining individual slots 323 configured to receive
a product
dispensing cartridge 400. Sensors 324 as discussed above are positioned in the
top face of
flat panel 321 so as to align with a bottom, horizontally moveable dispensing
drawer on each
cartridge 400, thus allowing sensors on the bottom of such drawers to activate
sensors 324 on
13
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
flat panel 321, in turn allowing the processor of control compartment 115 to
record
dispensing of product from a particular product dispensing cartridge 400. Top
shelf 320 also
includes bottom plate 326, which both mounts top shelf 320 to upper support
flanges 710,
and positions flat panel 321 a vertical distance above bottom plate 326.
As shown in FIGs. 8-11, while top shelf 320 is positioned immediately above
intermediate drawer assembly 360, as discussed above it is independently
mounted to chassis
300, allowing drawer assembly 360 to slide horizontally outward (in the
direction of arrow
1100 in FIG. 11) from chassis 300 for placement and retrieval of product. As
best viewed in
FIG. 11 (in which flat panel 321 has been removed for clarity), drawer front
800 may be
pulled outward in the direction of arrow 1100 from intermediate drawer
assembly 360, such
as by way of standard drawer slide rails 1102. Slide rails 1102 are attached
to both sides of
drawer assembly 360, allowing the drawer to be pulled outward from chassis 300
over drawer
assembly support plate 1101 without effecting top shelf 320 or bottom shelf
342, or the
dispensing cartridges 400 stored on them. Drawer assembly 360 includes a
hinged lid 802,
hinged to drawer body 804 via a hinge member 806. Hinged lid 802 is preferably
perforated
with a plurality of openings 808 allowing cold air to pass through drawer
assembly 360 so as
to keep contents of drawer assembly 360 cold with the rest of the product
stored in
refrigerated storage and dispensing unit 100. Hinged lid 802 may be provided a
separate lock
810 to provide restricted access to the contents of drawer assembly 360.
Drawer assembly
360 may be useful for storing product that was improperly or inadvertently
withdrawn from
dispensing cartridges, product that has already been dispensed but only
partially used, or
product in oddly shaped containers that do not fit into dispensing cartridges
400.
FIG. 12 shows drawer assembly 360 with bottom plate 326 of top shelf 320 in
place
above drawer assembly 360. Likewise, FIGs. 13 through 16 show drawer assembly
with
bottom plate 326 removed. Each of FIGs. 12 through 16 show cartridge release
mechanism
14
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
1210 pivotably mounted to bottom plate 326. More particularly, and with
continuing
reference to FIGs. 12 through 16, cartridge release mechanism 1210 includes
mounting arm
1212 pivotably mounted at pivot tab 328 to bottom plate 326. A plurality of
hooks 1214 are
mounted to the front face of mounting arm 1212, with one hook 1214 aligned
with each slot
323. Hooks 1214 are configured to engage a ridge on the back of each
dispensing cartridge
400. Thus, when cartridge release mechanism is in its downward position, hooks
1214
engage the back of dispensing cartridges 400 to prevent their removal from
refrigerated
storage and dispensing unit 100. When cartridge release mechanism is pivoted
to its upward
position, hooks 1214 disengage from their respective dispensing cartridges
400, allowing the
dispensing cartridges to be removed from their respective shelf 320 and 340.
Cartridge
release mechanism 1210 is preferably spring biased to its downward position,
so as to prevent
removal of dispensing cartridges 400 absent an affirmative and authorized
action to engage /
lift cartridge release mechanism 1210.
In order to cause cartridge release mechanism 1210 to lift hooks 1214, an
actuator
controlled by the processor, and more particularly a drive motor 1220, is
positioned at the
back of bottom plate 326. Drive motor 1220 drives a cam wheel 1222, which cam
wheel
1222 engages actuator 1213 on mounting arm 1212. Specifically, as cam wheel
1222 is
rotated by drive motor 1220 in the direction of arrow 12A (FIG. 13), mounting
arm 1212 is
rotated in the direction of arrow 12B (FIG. 13) to lower hooks 1214 into their
downward,
locking position. Likewise, as cam wheel 1222 is rotated in the direction
opposite of arrow
12A, mounting arm 1212 is rotated in the opposite direction of arrow 12B to
raise hooks
1214 into their upward, unlocked position. Drive motor 1220 is preferably
operated by
control compartment 115 in response to receive instruction from an authorized
use to either
lock or unlock dispensing cartridges 400 from their respective shelves.
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
In the event of a power loss, and in the case that during such power loss it
is necessary
or desirable to remove cartridges 400, a manual release bar 1230 is also
provided. Manual
release bar 1230 is slidably mounted to the top of bottom plate 326, and is
mounted for
movement in the direction of arrow 12C (FIG. 12). Release bar 1230 has a pull
tab 1232
positioned at the front end of release bar 1230. Preferably, pull tab 1232 is
hidden behind the
front wall 322a of cartridge guide tabs 322, such that front wall 322a serves
as a security
panel to prevent unauthorized access to pull tab 1232. Moreover, front wall
322a is
preferably mounted to bottom plate 326 with a plurality of security screws,
such that one may
only access pull tab 1232 with the appropriate tool, and with knowledge that
the hidden pull
tab 1232 is positioned behind front wall 322a of cartridge guide tabs 322. The
back end of
release bar 1230 includes a lifting head 1234 that engages the underside of
mounting arm
1212. When cam wheel 1222 is rotated so as to allow position hooks 1214 to be
pulled to
their downward, locking position, release bar 1230 may be pushed to its
rearmost position
(i.e., the position shown in FIGs. 12 through 16), causing lifting head 1234
to push against
mounting arm 1212 and lift mounting arm 1212 and hooks 1214 to their upward,
unlocked
position, in turn allowing removal of dispensing cartridges 400. As best seen
in FIGs. 15 and
16, lifting head 1234 includes a bottom angled edge 1236 that engages a set
screw 1240, such
that as lifting head 1234 is pushed rearward, bottom angled edge 1236
contacting set screw
1240 causes lifting head 1234 to slightly lift mounting arm 1212, pivoting
mounting arm
1212 upward and causing hooks 1214 to raise to their upward, unlocked
position.
While FIGs. 12 through 16 show mounting arm 1212 and hooks 1214 and related
mechanisms on top shelf 320, an identical assembly is likewise preferably
provided for
bottom shelf 340 (without intermediate drawer assembly 360).
FIG. 17 shows an exemplary dispensing cartridge 400 for use with the
refrigerated
storage and dispensing unit 100. Each dispensing cartridge 400 comprises a
generally
16
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
vertical housing 402 and a dispensing drawer 420 at the bottom of housing 402.
Dispensing
drawer 420 is configured for horizontal sliding out from and back into housing
402.
Moreover, as discussed in copending U.S. Patent Application Nos. ___ , the
specifications
of which are hereby incorporated by reference, each dispensing cartridge 400
includes a
dispensing mechanism which allows only a single product unit stored in
dispensing cartridge
400 (e.g., a single vial of pharmaceutical product, a single box containing a
syringe, etc.) to
be dispensed with each pull of dispensing drawer 420, blocks such product unit
from being
reinserted into dispensing cartridge 400 after dispensing drawer 420 has been
pulled out of
housing 402, prevents closure of the dispensing drawer until removal of the
single product
unit from the dispensing drawer 420, and prevents reloading of the next such
product unit
into the dispensing drawer 420 until dispensing drawer 420 is pushed fully
back into housing
402. Each dispensing cartridge 400 is configured to deliver the next product
unit by gravity
feed into the dispensing drawer 420 after the dispensing drawer 420 has been
fully closed
following a dispensing operation (i.e., full opening of the dispensing drawer
420 from
cartridge 400 and removing the dispensed product unit).
Each dispensing cartridge 400 includes a front face 404, two side walls 406,
and a top
wall 408. When positioned on one of top shelf 320 and bottom shelf 340, front
face 410 of
each dispensing cartridge 400 faces the front of refrigerator cabinet 102. A
product reload
door 410 is accessible from front face 404, which may be opened by a user to
reload
additional product. However, product reload door 410 has both a vertical
portion 410a and a
horizontal portion 410b, wherein access to horizontal portion 410b is blocked
when
dispensing cartridge 400 is fully inserted into refrigerated storage and
dispensing unit 100.
Thus, a user may only open dispensing cartridge 400, and thus access product
stored therein,
after the authorized removal of the cartridge 400 from refrigerated storage
and dispensing
unit 100.
17
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
Side walls 406 of dispensing cartridge 400 include a plurality of openings
412.
Openings 412, along with the open back (best seen in FIG. 18) of each
dispensing cartridge
400, provide airflow around product stored within dispensing cartridge 400 to
ensure that all
such product remains uniformly refrigerated. Further, front face 404 has a
wider width than
top wall 408, thus creating a space between adjacent dispensing cartridges 400
when they are
positioned on top shelf 320 and bottom shelf 340, further providing for
refrigerated airflow in
the spaces between adjacent dispensing cartridges 400. The outer edges 404a of
front face
404 of adjacent dispensing cartridges 400 abut one another so as to form a
relatively uniform
front wall with minimal air gap between them, thus keeping as much of the
refrigerated air
behind the front faces 404 of the dispensing cartridges 400 when the
refrigerator cabinet 102
is open. A pull tab 405 may be provided extending vertically along the front
face 404 of each
dispensing cartridge 400 so as to allow for easy removal of a single
dispensing cartridge 400
from top shelf 320 or bottom shelf 340 when desired (and unlocked), such as
for refilling
purposes.
As best viewed in FIG. 18, horizontal ridge 414 extends across the bottom,
rear side
of dispensing cartridge 400. Ridge 414 provides an engagement surface against
which hooks
1214 of cartridge release mechanism 1210 acts to lock each dispensing
cartridge 400 in place
on its respective top shelf 320 or bottom shelf 340. More particularly, when
hooks 1214 are
pivoted to their downward, locking positions, the forward end of a hook 1214
will engage the
ridge 414 of an aligned dispensing cartridge 400, thus locking the dispensing
cartridge 400 on
its respective shelf Likewise, when hooks 1214 are pivoted to their upward,
unlocked
position, the forward end of such hook 1214 disengages from the ridge 414 of
the aligned
dispensing cartridge 400, thus unlocking the dispensing cartridge 400 from its
respective
shelf and allowing its individual removal from refrigerated storage and
dispensing unit 100.
18
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
In a particular configuration, dispensing cartridges 400 may include a product
sensor
that detects the presence of product within dispensing cartridge 400. More
particularly, when
the dispensing drawer 420 is closed and there is product in the dispensing
cartridge 400, the
next product to be dispensed may push the front end of a sensing lever
downward so as to
cause the rear end of such sensing lever to rise, in turn breaking a
connection between the
product sensor and the sensor on the respective shelf 320 or 340 on which the
dispensing
cartridge 400 is positioned, thus indicating that there is product in such
dispensing cartridge
400 in position for dispensing. When the dispensing drawer 420 is open and
there is no
additional product pressing the front end of such sensing lever, the rear end
of the sensing
lever is lowered and connects the product sensor with the sensor on the
respective dispensing
shelf 320 or 340, indicating that there is currently no product in line to be
dispensed. When
the dispensing drawer 420 is closed, the next product in line in the
dispensing cartridge 400
moves into dispensing drawer 420, pushing down the front end of the sensing
lever and
causing the rear end of the product sensor to rise and lose its connection
with the sensor on
the respective dispensing shelf 320 or 340. It is contemplated that other
product sensor
configurations could be readily implemented by a person of ordinary skill in
the art.
In a particular configuration, dispensing cartridges 400 may also include a
drawer
position sensor located on the bottom of the dispensing drawer 420. The drawer
position
sensor may connect with a closed position sensor on the respective top shelf
320 and bottom
shelf 340 when the dispensing drawer 420 is closed, indicating to the control
compartment
115 that the dispensing drawer 420 is closed. The drawer position sensor may
also connect
with an open position sensor on the respective top shelf 320 and bottom shelf
340 when the
dispensing drawer 420 is fully open, indicating to the control compai __ tment
115 that the
dispensing drawer 420 is fully open.
19
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
Those skilled in the art will recognize that a wide variety of position
sensors and
product detection sensors may be used with dispensing cartridges 400 and top
shelf 320 and
bottom shelf 340 of the refrigerated storage and dispensing unit 100 described
herein without
departing from the spirit and scope of the instant invention.
As mentioned above, given the modular construction of refrigerated storage and
dispensing unit 100 discussed above, instead of dispensing cartridges 400, an
alternative
storage assembly may be provided as may be selected by persons skilled in the
art. As shown
in the side, cross-sectional view of FIG. 19, such alternative storage
assembly may, in certain
configurations, comprise an open-front storage box 500 equipped with a planar
radio
frequency identification ("RFID") antenna 550, which may receive and store
RFID tagged
product containers.
Open-front storage box 500 defines an open interior space 502 that may receive
products of varying shapes and sizes, and thus may be used to store products
that are not
configured for storage in and dispensing from dispensing cartridges 400, but
that are
nonetheless desired to be stored with such products in a single refrigerated
storage and
dispensing system 100. With continuing reference to FIG. 19 and to the rear
view of FIG. 20,
open-front storage box 500 may have a bottom face 504, which bottom face 504
may be sized
and otherwise configured to sit directly on flat panel 321 in the place of
dispensing cartridges
400, or alternatively on bottom plate 326. Open-front storage box 500 may
include ridges
514 on a back side thereof configured to engage with hooks 1214 of cartridge
release
mechanism 1210, thus allowing open-front storage box 500 to be locked to top
shelf 320 or
bottom shelf 340 in the same manner that dispensing cartridges 400 may be
locked to top
shelf 320 or bottom shelf 340. Open-front storage box 500 may include a slot
504 extending
into the upper body of open-front storage box 500 from a back side thereof,
which slot 504
receives planar RFID antenna 550. An electrical cable 552 may extend from
planar antenna
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
550 out of slot 504 for connection to control compartment 115. Planar antenna
552 may be
configured to read RFID tags positioned on products or product containers that
are to be
stored on open-front storage box 500, and more particularly to detect their
placement on and
removal from open-front storage box 500. Planar RFID antennas and RFID tags
readable by
them are readily commercially available and their construction is known to
those skilled in
the art, such that their specific configuration and operation is not further
detailed here.
A junction box may control a heater for an ammonia absorption chiller or the
compressor for maintaining a constant temperature in the chilled compartment
of refrigerator
cabinet 102. In certain configurations, the junction box may include a
processor, SSR or
SCR, I2C communication interface, NTC temperature probe, and power supply. If
the chiller
is ammonia absorption, the processor preferably runs a standard PID algorithm
and numeral-
impulse control with modifications for over-temperature. The over-temperature
function is
configured to shut down the heater when it appears that the chiller is
overheating due to low
gas, a bad or damaged heater, or high current. The nominal temperature setting
for the inside
of the chilled compai _______________________________________________ iment
will be controlled by the processor of control compartment 115
communicating with the junction box. Current status of the junction box may be
read by the
processor of the control compartment 115.
An AC/DC power supply with line filter is preferably used to provide a stable
voltage
for all of the electronics included in refrigerated storage and dispensing
unit 100. The output
of the power supply is preferably used to charge a backup battery. Both the
output of the
power supply and the backup battery are preferably controlled by a power
switch. The power
switch is preferably controlled by the processor of the control compartment
115 for selecting
how the electronics and the chilled compartment 115 will be powered. The
processor may
monitor the main power supply and backup battery via the I2C communications
interface.
21
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
In accordance with certain aspects of an embodiment of the invention, where a
freezer
compartment is included in refrigerated storage and dispensing unit 100, the
freezer
compartment preferably includes an enclosure with a compressor chiller,
shelves for holding
dispensing cartridges 400, an intermediate drawer assembly 360, dispensing
sensing shelves,
temperature sensing, LEDs, electric locks, a door sensor, a fan, a processor
controlled
thermostat, a power supply with UPS, and a communication link to chilled
compartment or
the control compartment 115. FIG. 21 provides a block diagram for the
foregoing
components. If provided, a freezer compartment preferably includes a freezer
interface that
contains I2C and GPIO signals necessary for communications with the processor
of the
control compartment 115. These signals are buffered and sent to the processor
through the
backplane 380. It is contemplated that a freezer compartment provided as
herein will be
configured in the same way as the chilled compartment and includes the same
features,
except that its temperature can be set below freezing to maintain products at
lower
temperatures than in the chilled compartment of refrigerator cabinet 102
discussed above.
All control and communications are preferably handled by the control
compartment
115. The vending refrigerator may be configured to communicate with a server.
In this
configuration, the server consists of a computer running application software
that is located at
an off-site facility. This application software processes incoming data from
the refrigerated
storage and dispensing unit 100 and generates the data necessary for inventory
control,
maintenance, alarms, billing, and any other essential tasks. The data is also
used to dispatch
personnel for maintenance, customer support for alarms, and refilling.
The server and refrigeration unit may communicate with one another, and form
part of
a fully integrated product supply, storage, and distribution system, as
further described below,
and as shown schematically in the exemplary flow diagram shown in FIG. 22.
22
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
The first element of the system is a user facility 600. The user facility 600
is the
facility at which the refrigerated storage and dispensing unit 100 is placed.
User facility 600
may be a physician's office, but it could be any other place at which the
refrigerated storage
and dispensing unit 100 is to be used, e.g., a pharmacy, a health department
office, etc.
Another element of the system is a product manufacturer 610, such as a company
that
manufactures the products that are to be dispensed through the vending
refrigerator. An
optional element of the system is a distributor 620, which is used by the
manufacturer 610 to
deliver the product to the user 600. A product partner 640 may also be
provided that has the
responsibility of managing the inventory of product in the refrigerated
storage and dispensing
unit 100. A managing partner 605 may be used in certain instances to control
the functions of
the refrigerated storage and dispensing unit 100. In some instances, the
managing partner
605 is the manufacturer of the refrigerated storage and dispensing unit 100
and has
responsibility for maintenance of the equipment and the data collected from
the refrigerated
storage and dispensing unit 100. A billing partner 615 may be responsible for
invoicing and
settling accounts with the various other members of the system. Insurance
provider 630 may
be another component, which is in communication with the billing partner 615
to manage
payment for spent product.
The system is implemented through an integrated network as shown in FIG. 23.
In
accordance with certain aspects of an embodiment of the invention, the
refrigerated storage
and dispensing unit 100 is communicatively connected with the control server
1705 at the
managing partner 605, the product manufacturer server 1710, the distributor
server 1720, the
partner server 1740, the billing server 1715, and the insurance server 1730. A
person of
ordinary skill in the art will recognize that the vending refrigerator need
not be connected to
all of the components listed above. For example, the refrigerated storage and
dispensing unit
23
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
100 may be connected to the control server 1705 and the control server 1705
may be used to
communicate with all other components as necessary.
The system described above is used to implement a method for distribution and
dispensing of products. A product is first delivered to the user 600 from the
manufacturer
610 or distributor 620. Data is collected from the control compartment 115
corresponding to
the contents and operation of the refrigerated storage and dispensing unit 100
and sent to the
control server 1705. The control server 1705 handles all transactions
concerning the products
dispensed through the refrigerated storage and dispensing unit 100. All data
including alarms
from the refrigerated storage and dispensing unit 100 are sent and processed
by the control
server 1705. The control server 1705 processes the data and determines whether
the
refrigerated storage and dispensing unit 100 needs to be refilled or if
maintenance is required.
Optionally, a billing server 1715 at the billing partner 615 may receive
information
directly from the refrigerated storage and dispensing unit 100 or the control
server 1705. The
billing server 1715 manages billing to and from user 600, billing to and from
insurance
company 630, and orders stock from the product manufacturer 610. The billing
server 1715
may also schedule visits from a product partner 640 to go to the user 600,
while coordinating
with the delivery of the product. The product partner 640 may be an
organization with
individuals qualified to store and maintain the physician's vaccine stock. In
such instances,
the product partner 640 preferably uses a CDC vaccine handling document in
establishment
of procedures. When a patient receives a vaccine, or other medication
dispensed through the
refrigerated storage and dispensing unit 100, the information is sent from a
scanned vial or
extracted from the POMIS (Physician's Office Management and Medical
Information
System) to the billing server 1715 to bill the insurance company 630 for the
patient to whom
the product was provided.
24
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
The control server 1705 will send stock refill requests to the billing server
1715 when
stock levels fall below pre-determined amounts. The billing server 1715 needs
to place such
orders in a timely manner to ensure that the physician's office does not run
out of any
medication, e.g., a vaccine. The control server 1705 will track all on-hand
inventory. The
billing server 1715 will track all orders for deliveries and provide delivery
information to the
control server 1705. All alarms from the refrigerated storage and dispensing
unit 100 in the
physician's office will be sent via control server 1705 to the billing server
1715 for
notification. Insurance 630 refers to entities that reimburse the product
partner 640 for the
cost of the drug, e.g., a vaccine, and reimburse the physician for
administering the drug.
Billing server 1715 will bill the insurance company 630 and dealing with
managing the
insurance payment transaction.
Manufacturer 610 refers to entities that are going to supply product, e.g.,
medications,
vaccines, etc. to the user 600 or product partner 640. The manufacturer 610
receives at
product manufacturer server 1710 an order from the billing server 1715. The
order is then
shipped directly to the user 600 or product partner 640 with the tracking
number and manifest
sent to the billing server 1715, which will relay that information to the
control server 1705. It
is contemplated that the product will arrive in a timely manner, e.g., within
48 hours of
shipment.
One exemplary method in accordance with an embodiment is provided in FIG. 24.
In
a first step 1800, an operator, such as a nurse in the physician office 600,
removes a single
product container (e.g., a vial stored in a dispensing cartridge 400) from the
refrigerated
storage and dispensing unit 100. In a second step 1805, the refrigerated
storage and
dispensing unit 100 records the removal and sends the information to control
server 1705. In
a third step 1810, the operator enters the information in the customer (e.g.,
patient) record and
the data is sent to the billing server 1715 for billing by extracting the
relevant information
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
from the POMIS. In the next step 1815, the billing server bills the insurance
company for
reimbursement. At step 1820, the control server 1705 recognizes and tracks the
use of the vial
and, if the number of vials goes below a par level, communicates with the
billing server 1715
to order more product. At step 1825, billing server 1715 requests a refill
from manufacturer
610 by placing an order with the manufacturer 610 for more product.
The manufacturer 610 then ships product; generates a tracking number,
manifest, and
invoice; and sends the information to the billing server 1715 at step 1830.
The billing server
1715 relays the tracking number and manifest to the control server 1705 and to
the product
partner 640 at step 1835. The refrigerated storage and dispensing unit 100 is
then refilled at
step 1840, and notifies the control server 1705 when it has been refilled at
step 1845. Then,
at step 1850, the control server 1705 informs billing server 1715 of product
delivery and
updated inventory levels. The billing server 115 then settles the
manufacturer's invoice for
the cost of the product at step 1855. The process is completed when the
billing server 1715
receives reimbursement from insurance at step 1860.
An exemplary general system flow for the above-described system is as follows.
It is
contemplated that fill orders can be submitted through the keypad of
refrigerated storage and
dispensing unit 100, a smart phone, or a mobile device with a software
application that
receives information from the refrigerated storage and dispensing unit 100 and
that can be
communicatively connected with the system, e.g., the control server 1705 or
billing server
1715. The filling system may also be controlled through a web page
communicatively
connected with the refrigerated storage and dispensing unit 100, e.g., through
the control
server 1705 or the billing server 1715.
The refrigerated storage and dispensing unit 100 may capture product
information
through the use of a bar code scanner. The bar code scanner may be located on
the control
compartment 115. The person that is charged with filling the refrigerated
storage and
26
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
dispensing unit 100 can scan each product, e.g., a vaccine, before re-filling
dispensing
cartridges 400. The refrigerated storage and dispensing unit 100 may contain a
server within
control compartment 115 that maintains communication between the user's office
and a
control server 1705 at a vendor that manufactures and maintains the
refrigerated storage and
dispensing unit 100. The refrigerated storage and dispensing unit 100 may
report every
movement of product and event or alarm requiring action to the manufacturer of
refrigerated
storage and dispensing unit 100.
As explained above, the dispensing cartridges 400 do not allow a product to be
returned through the dispenser drawer 420. If a product is removed, it can be
placed in
drawer assembly 360. Optionally, products that allow for multiple dosages can
be placed in
drawer assembly 360 after initial dosing from such product. Preferably,
refrigerated storage
and dispensing unit 100 only tracks whether a product is in a dispensing
cartridge 400. The
user is responsible for tracking payments and distribution of the product in
such multiple
dosage cases.
A doctor and / or nurse may utilize the following exemplary process in using
the
refrigerated storage and dispensing unit 100. The doctor, nurse, or other user
logs-in using
his or her own unique user code. The user opens the door of refrigerated
storage and
dispensing unit 100 and pulls the required vial from the dispensing drawer 420
of the
dispensing cartridge 400. If the user pulls the wrong vial, the vial may be
placed in drawer
assembly 360. Similarly, if the product is a multi-dose vaccine, the remainder
may be placed
in drawer assembly 360. The user then closes the door 105 of refrigerated
storage and
dispensing unit 100, provides the product to the patient or ultimate
recipient, records the
dosing in POMIS, and disposes of the vial or syringe under normal operation
procedures.
Dispensing is registered in refrigerated storage and dispensing unit 100 and
relayed, for
example, to the manufacturer of the refrigerated storage and dispensing unit
100 or any other
27
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
party monitoring the refrigerator's use. The billing system is preferably
configured to ensure
the product, e.g., vaccine, is billed within 24 hours of use to the insurance
company. Refill
orders are preferably placed when stock levels are reduced or at specific
intervals.
In a further exemplary process employed by a product specialist, the
refrigerated
storage and dispensing unit 100 may be optimally used in accordance with the
following
process. The manufacturer or manager of refrigerated storage and dispensing
unit 100
establishes an initial inventory of product, e.g., vaccines. When a product
vial is removed
from the refrigerated storage and dispensing unit 100, the reduction of
inventory is recorded
in the control compartment 115 and relayed to the managing partner 605 or
control server
1705. The managing partner 605 or control server 1705 recognizes when a stock
level, and
more preferably an unexpired stock level, falls below par and notifies the
billing server 1715
or partner designated to place and manage product orders. The billing server
1715, or the
partner designated to manage orders, places an order with the product
manufacturer 610. The
product manufacturer 610 ships the order to and alerts the billing server 1715
of the tracking
information, which is then relayed to the control server or
manufacturer/manager of the
refrigerated storage and dispensing unit 100.
The billing server 1715 or party designated to manage orders notifies a
product
partner and the manufacturer/manager of the data received from the
refrigerated storage and
dispensing unit 100, including preferably that there are X deliveries of
specific products
occurring the following day for scheduling purposes. The product partner
schedules a time to
visit the user's office and replenishes the refrigerated storage and
dispensing unit 100 from
the delivered product order. If the delivery arrives prior to the arrival of
the product partner
specialist, the user may place the product in an appropriate refrigerator to
maintain
temperature control.
28
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
The product partner specialist verifies the thermal indicator on the box is in
proper
condition; logs in via the keypad using a unique code; unlocks the vaccine
compartment;
replaces the product in accordance with industry standards (e.g., using First-
In, First-Out
(FIFO) principle); and scans the bar code of each vial and interacts with the
refrigerated
storage and dispensing unit 100 front panel LCD/touchscreen to identify the
product to be
loaded. The refrigerated storage and dispensing unit 100 and the manager of
the refrigerated
storage and dispensing unit 100 or manufacturer's software preferably records
the product
name, the number of doses received, the date the product was received, the
condition of the
product on arrival, the product manufacturer, the lot number and product
expiration date, as
determined by the scanner and the front panel dialog. The refrigerated storage
and
dispensing unit 100 may include a flashing LED(s) under the cartridge/slot to
indicate which
one to fill, and the refiller preferably verifies that the vaccine being
replaced is going into the
correct cartridge/slot one at a time. Expired products are preferably removed
and sent to the
manufacturer for reimbursement and/or replacement. Expired vaccines may occur
due to
power outages, being past their expiration date, or temperature fluctuations.
It is contemplated that the control server 1705 may be configured to allow for
the
return of expired products. This option could be included under an inventory
menu option
entitled "return to manufacturer/expired product." Expired products in the
dispensing
cartridges or in drawer assembly 360 can also be returned to the product
manufacturer for
disposal and/or reimbursement.
The product partner specialist ensures that all unexpired (and unrecalled)
vials in
drawer assembly 360 will remain there for future use. He or she then
optionally locks the
vaccine compartment, replaces any miscellaneous items as needed (labels,
boxes, containers,
etc.), and checks in with the user to see if there are any issues of any sort.
29
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
The product specialist also asks whether there are any maintenance items
needing to
be checked, and informs the manufacturer and/or manager of the refrigerated
storage and
dispensing unit 100. The temperature of the refrigerated storage and
dispensing unit 100 is
automatically controlled, such that there would be no need for the product
specialist to record
such information. The
product specialist then provides a summary of product usage,
preferably for the month, and answers any product related questions.
In accordance with an aspect of an embodiment of the invention, the system
employs
an exemplary inventory reconciliation process as follows. The product
specialist may
conduct a physical inventory of the refrigerated storage and dispensing unit
100 for
reconciliation with the automated refrigerated storage and dispensing unit 100
and
manufacturer/ control server 1705 recorded inventory levels. The product
specialist or other
user conducting the inventory interacts with the refrigerated storage and
dispensing unit 100
LCD/touchscreen 130 dialog or user input device 140 to note any and all
inventory
discrepancies. The recorded refrigerated storage and dispensing unit 100 and
manufacturer/
control server 1705 inventory levels are adjusted to match the physical
inventory, with a time
stamped note explaining the adjustment.
In some instances, it may become desirable to modify the input menus. An
exemplary
menu change process may include the following steps. If product demand is
expected to
change, e.g., required for back-to-school or flu season when certain vaccines
will be in higher
demand, then the menu and inventory may be changed. The product partner may
evaluate the
need for a second refrigerated storage and dispensing unit 100 or to change
the quantity of
product supplied. The product partner may submit a "menu change" to the
manufacturer or
manager of refrigerated storage and dispensing unit 100. The manager or
manufacturer will
then build the new menu and download the new menu to the refrigerated storage
and
dispensing unit 100 through the network. The manufacturer or manager of
refrigerated
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
storage and dispensing unit 100 may store all historical data on a server to
be used for
analysis as needed, such as location, product type (e.g., vaccine), and user.
The product
specialist arrives to the user's office and contacts the manager or
manufacturer technical
department for assistance with completing the menu change. The system is
designed to
include procedures when there is product remaining in the affected
cartridge(s)/slot(s). For
example, an "Extraction" option allows for movement of product without
generating a billing
invoice or replenishment order. The inventory is reloaded and the system is
updated.
If there is a malfunction or an alarm is otherwise activated, the system is
configured to
employ the following process. Once an alarm is activated, the refrigerated
storage and
dispensing unit 100 records the alarm and relays notification of the alarm to
the
manufacturer/manager of the refrigerated storage and dispensing unit 100. The
service
telephone number is preferably displayed on the display of the refrigerated
storage and
dispensing unit 100. The manufacturer/manager may notify the product
specialist as soon as
possible via e-mail, SMS, or any other electronic means. The product
specialist preferably
contacts the user to determine the cause of the alarm (e.g., unplugged unit,
temperature drop,
etc.) and to resolve the problem (if able). The product specialist may follow
a specified
protocol. The result of the call is logged on the manufacturer/manager
database for
evaluation by management. The information collected may include the date, name
of the
person spoken to, time, and any other pieces of information deemed to be
crucial by the user,
manufacturer or service provider. The product specialist may contact the
manufacturer/manager of the refrigerated storage and dispensing unit 100 for
technical
support if the issue remains unresolved. The manufacturer/manager may then
send a
technician as needed. Items that the technician may check include the length
of back-up
power available from the battery ¨ 48 hour minimum, 72 hour preferred, which
allows for
holiday weekends when the office may be closed for three days.
31
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
The following events are examples of items that might cause an alarm to be
triggered:
out of temperature range, door open beyond a predetermined period of time, no
main power
(i.e., switched over to battery), impending total power loss (i.e., no main
and battery drained),
no communication to server, illegal access or access try count exceeded,
specific
cartridge/slot not communicating, low batteries (test AC/DC load), dispensing
an expired
vaccine, and dispensing a recalled or quarantined vaccine. Records may be
stored, such as for
three years on the manufacturer's server, or as required by applicable law or
business
practice.
In an embodiment, the refrigerated storage and dispensing unit 100 may provide
redundant systems to address possible power outages. The refrigerated storage
and
dispensing unit 100 may include a back-up battery to provide power in the
event of a power
failure. The refrigerated storage and dispensing unit 100 may be programed to
lock and to
not dispense product in order to maintain temperature and protect the stored
products. A lock
override upon entry of a special access code may be provided to allow
emergency entry or for
removal of product to another location. In addition, after a configurable time
interval, the
chilled or freezer compartments may be shut down to conserve battery power and
the lock
will continue to remain locked during this stage. Once the battery fails
completely, the
refrigerated storage and dispensing unit 100 will be left in an unlocked
state.
A process may also be implemented to address recall and quarantine of stored
products. In such event, the manufacturer/ manager will record the
recall/quarantine for a
specific product, e.g., vaccine, including lot number on the refrigerated
storage and
dispensing unit 100. The product will be identified to be "On Hold" on the
display of
refrigerated storage and dispensing unit 100. In some embodiments, the
dispensing cartridge
400 will be locked to prevent dispensation of the product. The refrigerated
storage and
dispensing unit 100 may also flash LED(s) to warn against use of a product,
display a
32
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
warning on the front panel display, raise an alarm if quarantined product is
dispensed, and
lock down under software-configurable conditions. A product specialist may
remove recalled
vaccine from refrigerated storage and dispensing unit 100 after entering a
code and place
such recalled vaccine in the user's refrigerator until resolved or remove it
to its own facility.
The system can be further configured to allow transfer of vaccines between
different
locations, e.g., between physician offices in a vaccine partner territory.
Software to
implement the system may implement the following process. First, the
manufacturer sets
inventory levels for management of the process. The refrigerated storage and
dispensing unit
100 and the manufacturer software has the ability to accept transfer vaccine
from another
user. The software may include transport practices established for a vaccine
specialist, e.g.,
ability of a transport receptacle with 12-volt DC power convertor to cool the
container as an
option that can be plugged into electrical receptacles in a vehicle. The
software also tracks
temperature for cold chain. In some instances, the transport receptacle may be
another
refrigerated storage and dispensing unit 100 into which a dispensing cartridge
400 can be
plugged, and that is powered by a car. This special software would be used for
transport
only.
The software and system may also include solutions for discrepancies and
errors. In
one exemplary embodiment, when shipping errors occur, the product specialist
matches the
billing server or partner shipping request to the product manufacturer
shipping document and
alerts that billing server or partner of discrepancies. The software may
include a validation
process to cross check that what was ordered is what was delivered and
subsequently placed
in the individual cartridge/slot at the dispensing cartridge 400.
Having now fully set forth the preferred embodiments and certain modifications
of the
concept underlying the present invention, various other embodiments as well as
certain
variations and modifications of the embodiments herein shown and described
will obviously
33
CA 03068266 2019-12-20
WO 2018/237130
PCT/US2018/038731
occur to those skilled in the art upon becoming familiar with said underlying
concept. It
should be understood, therefore, that the invention may be practiced otherwise
than as
specifically set forth herein.
34
