Method and apparatus for the dispensing of drugs

A system and apparatus are described in which modular receptacles are filled and transported to automatic dispensing machines for later retrieval and distribution. A system of the present invention includes the loading, refilling, and replacement of the modular receptacles at various stages in the process of the invention. A preferred embodiment of the present invention relates to a method for distribution of items such as medical supplies and drugs.

BACKGROUND AND SUMMARY OF THE INVENTION 
The present invention relates generally to the dispensing of items, such as 
drugs, and more particularly, a system and apparatus for the dispensing of 
items such as drugs, including an apparatus for storing, transporting, 
receiving, refilling, and tracking drugs through their channels of 
distribution. 
It is known in the art to dispense drugs at a healthcare location or other 
care facility through an automated dispensing machine, for example, such 
as the one described in U.S. Pat. No. 5,014,875. The entire contents of 
U.S. Pat. No. 5,014,875 are hereby incorporated by reference herein. As 
described in that patent, a pharmacist or pharmacist technician arranges 
for drugs to be moved to each automated dispensing machine and be manually 
placed into drawers, and more particularly, pockets within those drawers 
for later removal and administration by doctors and nursing staff. The 
patent referred to above describes the benefits of such an approach, as 
well as the drawbacks of previously known systems for accomplishing 
similar purposes. 
The apparatus of the present invention comprises a unique receptacle having 
a bottom and a plurality of sides and an attached top that may be actuated 
to open to expose the contents of the receptacle. The receptacle further 
includes an information storage device, such as a memory chip, for storing 
information regarding the contents of the receptacle. 
In a preferred embodiment, the receptacle includes an electronic actuated 
latch for the top opening that opens upon receipt of required information 
to be inputted by an operator. The latch affords a safety solution for the 
receptacle through the entire process of medication distribution, that an 
unauthorized person cannot gain access to the receptacle other than by 
vandalizing the receptacle. 
The unique receptacle of the present invention may be adapted to reside in 
an automated dispensing machine along with a plurality of other like 
receptacles. The receptacles are preferably configured in such a way to 
allow for an efficient and optimum placement within the dispensing machine 
for access by an operator, such as a nurse or doctor or other authorized 
individual. In this embodiment, each receptacle preferably contains 
individual packages of particular drugs, drug kits, medical supplies, or 
combinations of these. Individual receptacles may have multiple types of 
drugs or medical supplies for one particular patient or a plurality of the 
same type of drug or medical supply for use with several patients. In this 
embodiment of the invention, the receptacles each contain associated 
hardware to support information about the contents of the receptacle in 
the automated dispensing machine. Likewise, the data entry device 
associated with the automated dispensing machine enables an operator to 
enter certain requested information, such as operator identification 
information or requested drug information or patient identification 
information, which will then be electronically transmitted to the 
appropriate receptacle within the automated dispensing machine which 
actuates the latch to open the top of the appropriate receptacle for 
access by the operator. All of the information for these transactions are 
maintained by the system, so that a record of the operator, patient, drug 
requested, receptacle accessed, etc. is available. 
In another embodiment of the present invention, a system is described in 
which the receptacles are loaded with particular items at a batch facility 
then "programmed" with a memory chip containing information. Information 
about the items loaded into each receptacle may be stored in information 
storage devices that may be integral to each receptacle and/or information 
about the items loaded into each receptacle may be put in bar code form on 
a bar code label and placed on the receptacle. The receptacles with the 
items now contained within them are then closed and transported to a 
receiving station, such as a pharmacy at a healthcare facility. There, 
information regarding the contents of each receptacle may be obtained from 
the receptacle's information storage device. In another embodiment, 
information regarding the contents of each receptacle may be scanned with 
a hand-held scanner reading a bar code label that was placed on each 
receptacle at the batch facility. Data obtained from the information 
storage device and/or from scanning the bar code labels may be stored in a 
computer at the receiving station for inventory control purposes. The same 
computer at the receiving station may be in communication with automated 
dispensing machines, even though the automated dispensing machines may be 
at a remote location from the receiving station computer. As 
users/operators of the automated dispensing machine enter information to 
gain access to the contents of the receptacles within the automated 
dispensing machine, the operator-entered information may be delivered to 
the receiving station computer to maintain a real-time inventory of each 
receptacle in each automated dispensing machine. The receptacle's 
information storage device may also maintain real-time inventory of the 
receptacle's contents as users/operators gain access to the contents of 
the receptacle. 
In another embodiment of the present invention, a manual refill cart is 
provided with a surface to receive receptacles. This refill device is used 
when filling receptacles with drugs from inventory (e.g., in the hospital 
pharmacy). The manual refill cart may have on board electronic connections 
for facilitating communication between each receptacle and a computer in 
association with the cart. 
The manual refill cart may have a bar code scanner attached to it to scan 
the bar codes on the unit dose packages of drugs to be loaded into the 
receptacle. The information from the bar coded packages of drugs is 
transferred from the bar code scanner and into the computer of the refill 
cart and/or into the memory chip of the receptacle. This enables the 
memory chip to maintain the information about the items stored in the 
receptacle. 
The present invention overcomes many of the disadvantages of known 
approaches to drug distribution. There is no manual operation needed for 
bagging or unbagging medications at the nurses station for later use with 
patients. The receptacle of the present invention may arrive at the nurses 
station ready for use with patients without further handling of the drugs 
until administration to the patient. The receptacle also allows for fewer 
human errors in drug handling. In known systems, a drawer of drugs may 
open exposing several pockets with different drug varieties. With the 
preferred embodiment of the present invention only one receptacle opens at 
a time exposing only the drugs in that receptacle. Loading of receptacles 
is safer too. Since typically only one type of drug would be placed in 
each receptacle there is less chance that a person loading that one type 
of drug will accidentally load a second variety in the same receptacle. 
Because the tops of the receptacles are preferably sealed closed until 
opened automatically upon receipt of an authorized signal at a delivery 
station, it greatly lessens the need for skilled staff to handle the 
receptacles. In other words, if the receptacle cannot be opened without 
proper receipt of signals from a delivery station, such as a dispensing 
machine, then there is less need to have sophisticated personnel for 
transport of the receptacles. 
The present invention may also be an intelligent receptacle. In a preferred 
embodiment, information about the contents may be integral to the 
receptacle, such as by bar code or by electronic chip that is machine 
readable. This enables tracking of the contents, such as lot numbers and 
expiration dates of the contents, for example. When this information is 
ported to the dispensing machine and then to a central computer system, 
expiration dates of each drug in each receptacle may be monitored for 
replacement at the proper time. 
A unique latch may also be employed with the receptacles. The latch may be 
comprised of bimetallic wire which contracts when it is heated by current. 
Upon contraction the wire pulls to one side and opens the latch allowing a 
spring to pop the lid open. 
Several other features and advantages of the present invention will be 
readily apparent from the following detailed description of the invention, 
the attached drawings of the invention and the claims.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
Referring now to the Figures, there is shown in FIG. 1 a receptacle 30 of 
the present invention. The receptacle 30 has a plurality of sidewalls 32 
that define a storage compartment 42 which is best shown in FIG. 2. In 
FIG. 2, a top 34 is opened and closed about a hinge 40. A latch assembly 
38 is formed between the top 34 and one of the sidewalls 32 to keep the 
top in a closed position until an authorized operator gains access to the 
receptacle. The latch assembly 38 includes a latch member 44 and a latch 
receiving pocket 46. 
The receptacle 30 may be used to contain various items, for example, 
medications. Each receptacle may house multiples of one type of drug or 
medical supply or it may house several varieties of drugs or medical 
supplies in the storage compartment 42. The receptacle of the present 
invention is adapted for use in a variety of systems. For example, it may 
be used at a patient's bedside table, on a medication cart, as a part of a 
drug administration kit in an operating room environment, or in many other 
scenarios both in and out of the medical industry. The invention has been 
described herein with reference to the medical industry but it is to be 
recognized that the invention has far reaching application in many 
industries. 
The receptacle of the present invention may also be used as a removable 
return container for later disposing of items, such as used or discarded 
medicine administration items. The receptacle of the present invention may 
also be adapted for communication with one or more devices via one of 
several possible communication means. For example, the receptacle may 
communicate via a chip inside the receptacle that has been programmed with 
information, and the chip may be adapted for communication with another 
electronic device to download, or share the information. Another form of 
communication may be remote, such as via a RF proximity chip in the 
receptacle for RF communication with a RF station. Of course, the 
receptacle 30 may also be "dumb," without on-board intelligence, and 
information about its contents may be contained within a bar code, for 
example, placed on the receptacle. In such an application of the 
invention, a receiving area of an apparatus, for example on or in an 
automatic dispensing machine, may acquire the necessary information 
through scanning of the bar code on the receptacle to enable the 
dispensing machine to know sufficient information about the contents of 
the receptacle. The receiving area may be a drawer in an intelligent 
dispensing machine having either an on-board computer processor or a 
connection to one remote therefrom. 
In another embodiment, the receptacle 30 may have limited on-board 
intelligence. For example, the information storage device or the bar code 
label of the receptacle 30 may only contain information about the 
receptacle, such as the receptacle number (e.g., #1234567). This 
pre-programmed information would typically be entered when the receptacle 
30 is filled. In this embodiment, a regular label (not a bar code label) 
or marking on the receptacle itself with the receptacle number may be used 
and the operator/user may manually enter the receptacle number into the 
computer having the pre-programmed information about the contents of the 
particular receptacle. 
The receptacle 30 of the present invention may be refilled and reused many 
times in a preferred embodiment hereof. In a unique system of the present 
invention, a refill station may be provided for refilling each receptacle. 
If the receptacle is "intelligent", it may be programmed with information 
at the refill station and the refill station may be so adapted to provide 
this communication to the receptacle. The refill station may be at a 
pharmacy or at a distribution center in the application of this invention 
to the medical industry. 
The receptacle 30 may be made from injection molded plastic, or formed from 
metal and as such, may be durable and reusable multiple times. 
Alternatively, the receptacle 30 may be made from inexpensive, disposable 
materials for discarding after use. 
The receptacle 30, may also include a label 36 for identification of the 
contents within the receptacle and/or some or all of top 34 may be 
transparent. In FIGS. 3 and 3A, the receptacle 30 is shown in greater 
detail. The hinge assembly 40 includes a spring 48 and a pin 50 which join 
the receptacle compartment with the top 34. While a hinged top is 
preferred, a sliding top may be used. The receptacle 30 may- further 
include a compartment 58 for housing a latch assembly 52. The latch 
assembly 52 may include a latch member 56 and a cover 54. 
The latch assembly is shown in greater detail in FIGS. 4-7. FIG. 4 shows 
the latch member 56 in a closed position while FIG. 5 shows the latch 
member 56 in an open position. A switch 57 may electronically inform an 
automated dispensing machine computer that the top 34 is in an open or 
closed position. A memory chip 62 may store information concerning the 
receptacle. This memory chip 62 may store a wide variety of information, 
including the data in the Hearst Corporation's National Drug Data File, as 
shown in Table 1, such as expiration date, lot number, NDC number, type of 
drug or medical supply dosage, size of packages, number of items in the 
packages, etc. The memory chip 62 can also store information about the 
receptacle 30, including, when it was put in service, how many times it 
has been used, etc. This is beneficial because the receptacles 30 will 
have a limited useful life and it is desirable to take receptacles out of 
service before they fail (e.g., hinge breaks, latch breaks, etc.). 
The receptacle 30 itself may be a medication package that contains drugs 
and a package insert. The receptacle 30 may replace bottles and other 
types of standard medication packages. An electrical communication contact 
66 enables connection from the receptacle to a receiving location within 
an automated dispensing machine, thus facilitating communication between 
the receptacle and the computer associated with the automated dispensing 
machine. When required signals are received at the electrical contact 66 
from the automated dispensing machine, an electronic circuit, such as the 
one shown in FIG. 22, actuates a muscle wire 64 causing the latch to be 
actuated and thus opening the top 34. The muscle wire works by receiving a 
current and upon increasing in temperature the wire 64 pulls to one side 
by shrinking and thereby causes the latch to be susceptible to a spring 
force acting upon it from a spring in the hinge assembly 40. The spring 48 
pushes the top open when the latch is freed. In a preferred embodiment, 
the lid or top 34 will pop open about 15 degrees when the latch is opened. 
An advantage of having the latch assembly as a separate component that can 
be removed from the receptacle 30 is that the latch assembly 52 and its 
components are more expensive and have a longer life expectancy than the 
storage compartment part of the receptacle 30. Therefore, the latch 
assembly 58 can be reused if the rest of the receptacle cracks or breaks 
(e.g., hinge breaks, etc.). The latch assembly preferably cannot be 
removed unless the top is opened. 
FIGS. 8 and 9 show a bottom portion of the receptacle 30. Each receptacle 
may include legs 27, 29, 33 and 35 as well as a hook member 37 for 
engagement of the receptacle to a location, such as in an automated 
dispensing machine. Alternatively, the legs themselves may include 
catching or engagement features. An opening 39 enables contact by the 
electrical connection 66 with a port at the automated dispensing machine. 
FIGS. 10-13 show other features of the present invention. In FIGS. 10 and 
11, the receptacle 30 is shown stacked upon a similar receptacle 70. Legs 
72 and 74 of receptacle 70 may be designed to reside within a location 
within an automated dispensing machine and/or within an area on a top 
surface of another receptacle. This allows for stacking of receptacles on 
each other for ease of storing and transportation. FIG. 12 shows a 
double-wide receptacle 80 with top surfaces 82, 84 and latch 86. FIG. 13 
shows the interior compartment of receptacle 80 as well as hinge assembly 
88. It is to be appreciated that the receptacles may come in a variety of 
sizes and shapes according to the particular use and storage location they 
are intended for. The receptacles are preferably modular in design to 
enable them to be used in combination, for example in a drawer of an 
automated dispensing machine, with several other similar receptacles, 
fitting in close proximity to one another to efficiently use the space 
available in each drawer. 
FIGS. 14, 14A and 14B show views of the receptacles of the present 
invention installed within an automated dispensing machine 110. Zones or 
locations 100 within a drawer 114 of the dispensing machine 110 are 
adapted to receive receptacles, such as receptacle 102. A terminal display 
112 may be provided with the machine 110 to enable an operator to review 
displayed information. A keypad 113 may be provided at the dispensing 
machine 110 to enter certain required information. A docking station 104 
may be provided at the dispensing machine 110 for receiving receptacles, 
such as receptacle 102 within engagement receiver 126, leg receivers 120, 
122 and electrical port 124. In this manner, each receptacle, such as 
receptacle 102, may be docked at the machine 110 to enable certain 
information stored within the memory of the receptacle to be downloaded 
into a processor or computer associated with the machine 110. If the 
receptacle 102 is to be loaded into a drawer 114 of the dispensing machine 
110, the drawer 114 may pop open to allow the receptacle 102 to be loaded 
into the correct zone 100 of the drawer 114. 
Within each drawer 114, there may reside a tray 115 for holding receptacles 
99, etc. Individual zones 100 are adapted to receive individual ones of 
said receptacles. Spring assemblies 130, 128 function in a manner to be 
described hereinafter. The spring assembly 128 is shown in greater detail 
in FIG. 15B to include springs 136 and 138. 
Zone 100 shown in FIG. 15A also includes pockets 133, 135, 137 and 139 for 
receiving the legs of a receptacle. FIG. 16, 17 and 18 show the insertion, 
locking, and release, respectively, of a receptacle 142 being placed into 
a drawer tray 115. A nested or adjacent receptacle 140 is also shown 
already in place. Compression spring 143 is shown in its relaxed state in 
FIGS. 16 and 18 and is compressed and not in view in FIG. 17. Latch member 
145 is shown in cross section view in contact with electrical circuit 151. 
Latch engagement member 150 is shown in FIG. 16 in a position ready to 
receive the retaining hook 152 of engagement member 148 of receptacle 142. 
As shown in FIG. 17, when the engagement member 148 is depressed into the 
area 149 (shown in FIG. 16), it catches or engages the end 154 of latching 
engagement member 150. In FIG. 18, latch engagement member 150 is actuated 
away from the engagement member 148 (moved to the right as shown in FIG. 
18), thereby releasing the connection between the engagement member 148 
and the latch engagement member 150 which allows the spring 143 to return 
to its relaxed state pushing receptacle 142 up and out of zone 100 to 
enable an operator to remove the receptacle from the machine 110. The 
actuation of the latch engagement member 150 away from the engagement 
member 148 may be done by a muscle wire mechanism such as in FIG. 22 or by 
other suitable means. 
FIG. 19 shows a drawer 114 with a track 160 and rail 162 that is adapted to 
reside within the machine 110. Wires 164 lead from a processor within the 
machine 110, along, for example, path 165 to each of the zones, such as 
zone 100, to carry communication between the receptacles 30 and the 
machine computer. FIGS. 20 and 21 show other views of the drawer 114. In 
FIG. 21, a grid 168 may be installed along the rail 162 to be read by 
sensor 169 so that the computer aboard the machine 110 knows how far each 
drawer 114 has been pulled out of the machine, thereby exposing rows of 
receptacles 30. The sensor 169 may be an optical sensor or other suitable 
sensor adapted to read the bars or grids of 168 and communicate that 
information via wires 166 and through wires 164 to the computer. In 
another embodiment, RF communication links may be used instead of or in 
addition to, wires 166 and 164. In accordance with a preferred embodiment 
of the present invention, the drawer will be open before the top of the 
receptacle is popped open or the receptacle itself is popped up to be 
removed from the drawer. 
FIG. 22 shows a preferred embodiment of an electrical wiring circuit for 
use with the latch assembly of each receptacle 30. The circuit 
communicates with the muscle wire which controls the movement of the latch 
to enable the door to open on each receptacle. The inputs to the circuit 
may be from the computer onboard the machine 110. When an operator enters 
required information to access a receptacle, the computer may send the 
necessary signal to the receptacle via the circuit to open the latch. As 
stated above, the latch may be opened by spring force applied when the 
muscle wire retracts under current to free the latch for movement. 
In one preferred embodiment of the latch assembly of the present invention 
a microprocessor is used. The microprocessor may include an analog to 
digital converter (A/D) and a pulse width modulator (PWM). The PWM 
produces a fixed frequency, variable duty cycle output. It is fed into a 
RC filter which produces a DC voltage between zero and five volts, 
depending on the duty cycle. A voltage follower, n-channel FET, a bipolar 
transistor, or other kind of amplifier circuit is preferred to drive the 
muscle wire. The FET's are used to address a single muscle wire. The row 
drivers are p-channel FET's that supply the current generated by the 
voltage follower. The microprocessor outputs zero volts to the gate of the 
desired row and plus five volts to the rest. The column drivers are 
n-channel FET's that sink current to ground. The microprocessor outputs 
plus five volts to the gate of the desired column and zero volts to the 
rest. In a matrix of muscle wires, each wire has a diode in series with it 
to isolate it from the other muscle wires in the matrix. The current sense 
resistor generates a feedback voltage to the microprocessor proportional 
to the amount of current flowing in the muscle wire. The temperature 
sensor generates a voltage proportional to the ambient temperature. 
The algorithm in the microprocessor is preferably structured as follows: 
1. Select the desired row and column drivers. 
2. Read temperature sensor. 
3. Determine starting duty cycle and desired feedback target as a function 
of temperature (may be done via a look-up table). 
4. Start the PWM generator. 
5. Read the feedback voltage. 
6. Compute error=(current feedback reading)-(desired target) 
7. If error less than zero, the output current is too low, increase duty 
cycle. 
8. If error greater than zero, the output current is too high, decrease 
duty cycle. 
9. If error equals zero, do not adjust duty cycle. 
10. If duty cycle cannot be increased, circuit may be broken. Shut off the 
PWM generator and report error to system. 
11. If the duty cycle is below a predetermined threshold, there may be a 
short-circuit. Shut off the PWM generator and report error to system. 
12. Check elapsed time since muscle wire was energized. If above desired 
time, shut off PWM generator. 
13. Wait for PWM value to stabilize. 
14. Go back to step 5. 
FIG. 23 shows a group of configured receptacles 170 and 180, for example. 
The top 172 is open exposing the internal compartment 174 and in this 
example, syringes containing a predetermined drug 176 are shown inside the 
compartment 174. Visible on the surface of each top of each receptacle is 
a label with printed drug information on the label as well as a bar code 
containing additional information about the item contained within that 
particular receptacle. 
It should be appreciated from the foregoing description that the present 
invention is useful in the medical drug and supply field, however, the 
present invention has applicability to a broad range of industries apart 
from the medical industry, where similar inventory control and security 
measures are preferred. The present invention is not intended to be 
limited to the medical supply and drug industry. 
FIGS. 24-26 show three (3) respective system diagrams for system 
implementations of the present invention beginning with a wholesaler all 
the way to a patient's bedside. As shown in FIG. 24, the wholesaler 
receives the medications and fills the receptacles of the present 
invention with doses of the medications. These receptacles are then 
transferred to a pharmacy, such as a hospital pharmacy, where they are 
next loaded into an automated dispensing machine. From the automated 
dispensing machine, the medications may be removed by appropriate 
personnel from the receptacles and administered to a patient at the 
patient's beside. The lower portion of the diagram of FIG. 24 shows a flow 
of information from the automated dispensing machine to the various 
computer systems in communication with the computer of the automated 
dispensing machine. For example, as FIG. 24 demonstrates, information 
concerning drugs administered to patients may be communicated to a 
hospital pharmacy computer, the wholesaler's computer, and the packaging 
company computer. FIG. 25 shows a similar diagram, however, in this 
implementation, the receptacles are not filled prior to the drugs arriving 
at the automated dispensing machine. Instead, the receptacles are refilled 
at the automated dispensing machine and arrive at the automated dispensing 
machine in unit dose packs. FIG. 26 shows another embodiment of a system 
of the present invention in which unit dose packs and prefilled 
receptacles are delivered to the automated dispensing machine where some 
previously existing receptacles at the automated dispensing machine are 
swapped for new receptacles. 
Many advantages are derived from the receptacle of the present invention. 
Another advantage is seen from FIGS. 24-26. Due to the self-contained 
nature of each receptacle, much of the processing and handling of 
receptacles may be done automatically. For example, in FIG. 24, an 
automated storage and transfer mechanism 200 may receive medications in 
packages and move the packages to a station where the receptacles are 
filled with the packages by robotics means. 
FIGS. 27A through 27F show flow diagrams of preferred embodiments of the 
present invention whereby the receptacles, referred to as Cubies.TM. by 
the present inventors, are shown to be prepared at a pharmacy, through a 
pick process, a refill process, and a return process. Several possible 
modifications to these flow processes are able to be made without 
departing from the present invention. These flow diagrams are offered as 
an example. 
Numerous modifications and variations in the invention are expected to 
occur to those skilled in the art upon considerations of the foregoing 
descriptions. The invention should not be construed as limited to the 
preferred embodiments and modes of preparation described herein, since 
these are to be regarded as illustrative rather than restrictive.