Note: Descriptions are shown in the official language in which they were submitted.
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ORAL SYRINGE PACKAGING SYSTEM FOR HOSPITAL PHARMACIES
BACKGROUND OF THE INVENTION
1. Field of the invention
[0001] The present invention relates generally to oral syringe packaging
equipment
and more specifically to a partially automated system for preparing patient-
specific
doses of selected pharmaceutical liquid medication for administration by oral
syringe
on a just-in-time basis, for use in a hospital pharmacy.
2. Description of the Background
[0002] Oral syringes are well known instruments in the medical fields and are
used to
administer liquid medicine into the mouth, as an alternative to pills which
can present
a choking hazard or be expectorated, typically for infants/children and
uncooperative
or geriatric adults. The oral syringe directs liquid medicine to the back of
the throat
prompting a swallowing response. Injectable syringes, on the other hand, are
used to
administer medication into the body by injecting its contents through the
skin.
Injectable syringes utilize a needle on the tip of the syringe. Injectable
syringes must
be manufactured and packaged in a sterile environment. Research has shown that
the
potential for adverse drug events within the pediatric inpatient population is
about
three times as high as among hospitalized adults. See, Joint Commission,
Preventing
Pediatric Medication Errors, Issue 39 (2008). According to the Commission
Report,
the most common types of harmful pediatric medication errors were improper
dose/quantity (37.5 percent) and unauthorized/wrong drug (13.7 percent),
followed by
improper preparation or dosage form. Oral syringes help to minimize these
problems and are considered the gold standard for delivering medicine to
children.
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[0003] Oral syringes are comprised of a simple piston pump with a plunger that
fits
tightly in one end of a cylindrical tube (the barrel) and can be pushed or
pulled along
inside the barrel to create negative or positive relative pressure within the
barrel that
causes the syringe to take in or expel a liquid or gas through an orifice
(nozzle) at the
opposing end of the barrel. The barrel of an oral syringe is typically made of
plastic
and is at least partially transparent along its length with graduated markings
to
indicate the volume of fluid in the syringe based on the position of the
plunger visible
within the barrel. Oral syringes come in a wide range of sizes and with some
variation
in configuration. For example, some oral syringes have the nozzle located
along the
central axis while others have the nozzle offset from the central axis this
variability
makes it difficult to automate the filling process. Oral syringes are commonly
marked
in units of milliliters and come in standard sizes ranging from 0.5 to 60
milliliters. An
annular flange partially or fully encircling the outside surface of the barrel
is typically
provided to facilitate compression of the plunger into the barrel. The plunger
is also
typically plastic as this provides a good seal within the barrel and is
inexpensive to
produce so as to be disposable, reducing the risk of contamination or
transmission of
communicable disease.
[0004] Pharmacies at in-patient medical facilities and other medical
institutions fill a
large number of prescriptions on a daily basis including prescriptions for
liquid or
compounded suspension medicines to be administered by oral syringe, and must
do so
accurately for medical safety reasons. The volume of an oral pediatric
prescription's
dose is determined by the child's weight. This makes it impractical to stock
pre-filled
syringes due to the wide range of fill volumes required. As a result,
pediatric oral
liquid doses are prepared in the hospital pharmacy on a patient-specific, just-
in-time
basis. The process of filling numerous, variously sized single dose
prescriptions for
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delivery by oral syringe is time consuming, labor intensive and prone to human
error.
To insure that the medication is packaged error-free, the pharmacy technician
must
make sure that: (1) the syringe contains the correct medication; (2) the
syringe
contains the correct amount of medication; (3) the syringe is capped
correctly; (4) the
medication has not expired; (5) the medication has not been recalled; (6) the
medication, when required, is shaken; (7) the medication, when required, has
been
properly refrigerated; (8) the medication, when required, has been properly
protected
from exposure to light; (9) the information on the syringe label is correct;
(10) the
syringe is placed into the correct bag; (11) the information on the bag
containing the
syringe is correct; (12) the bag is properly sealed; and (13) the syringe is
protected
from cross contamination from other medications. The process typically
requires a
pharmacist or pharmacy technician to retrieve the correct medication from a
storage
cabinet or refrigerated storage area. The liquid medications are typically
stored in a
container sealed with a safety cap or seal. After confirming the contents of
the
retrieved container and shaking the medication (if necessary), the technician
manually
opens the cap and inserts the tip of an oral syringe into the container,
withdrawing the
plunger to draw the medication into the barrel of the syringe. After filling
with a
proper amount, the tip of the syringe is covered with a cap for transport to
the patient
and the syringe is labeled to indicate its content, the intended recipient,
and then
bagged. Prior to administering the dose, the nurse can determine the amount of
the
dose by observing where the tip of the plunger or piston is located in the
barrel. Oral
syringes are relatively inexpensive and disposable.
[0005] Currently, the degree of automation in the hospital pharmacy for the
packaging of oral syringes is very limited. Islands of automation exist, such
as
automatic labeling of the syringe and bagging of the filled and capped
syringe.
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However, the filling and capping are done manually. Scanners, cameras, bar
code
readers and track-and-trace technology have not been applied on an integrated,
comprehensive basis for the packaging of oral syringes in the hospital
pharmacy. The
potential to reduce medication errors using this technology is significant.
Automated
systems have been developed by Baxa, Inc., For Health Technologies, Inc.,
Intelligent
Hospital Systems and others for the automated filling of injectable syringes.
[0006] For example, U.S. Patents 6,991,002; 7,017,622; 7,631,475 and 6,976,349
are
all drawn to automated removal of a tip cap from an empty syringe, placing the
tip
cap at a remote location, and replacing the tip cap on a filled syringe. U.S.
Patents
7,117,902 and 7,240,699 are drawn to automated transfer of a drug vial from
storage
to a fill station. U.S. Patent 5,884,457 shows a method and apparatus for
filling
syringes using a pump connected by hose to a fluid source. U.S. Patent
7,610,115 and
Application 20100017031 show an Automated Pharmacy Admixture System (APAS).
U.S. Application 20090067973 shows a gripper device for handling syringes of
different diameters with tapered or angled gripper fingers. U.S. Patent
7,343,943
shows a medication dose under-fill detection system. U.S. Patent 7,260,447
shows an
automated system for fulfilling pharmaceutical prescriptions. U.S. Patent
7,681,606
shows an automated system and process for filling syringes of multiple sizes.
U.S.
Patent 6,877,530 shows an automated means for withdrawing a syringe plunger.
U.S.
Patent 5,692,640 shows a system for establishing and maintaining the identity
of
medication in a vial using preprinted, pressure sensitive, syringe labels.
[0007] The foregoing reference machines for packaging injectable syringes. The
packaging process required for injectable syringes is significantly different
than that
for oral syringes. Injectable syringes must be packaged in a sterile
environment as the
medication is injected into the body. This requirement adds cost and
complexity to
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the machine. Injectable medications, when packaged on a just-in-time basis as
with
the Baxa, For Health Technologies, and Intelligent Hospital System machines,
must
typically be prepared by the machine before the medication is filled into the
syringe.
The medication preparation process involves diluting the medication or
reconstituting
the medication from a powdered state with water. This process adds expense and
slows down the packaging process as well. The Intelligent Hospital Systems
syringe
packaging system is designed to be used to package cytotoxic medications which
are
hazardous. To avoid harm to the operator, this machine uses a robot located
within an
isolating barrier at considerable cost. The Baxa, For Health Technologies, and
Intelligent Hospital System machines require the use of expensive disposable
product
contact parts when a different medication is to be filled. The foregoing
machines are
not suitable for packaging oral syringes due to their capital cost,
complexity, slow
production rates, inability to handle oral medication containers, and the
requirement
of expensive disposable contact parts. Consequently, existing automation does
not
address the needs of medical institutions desiring an affordable pharmacy
automation
system for patient safety, prescription tracking and improved productivity.
The
present invention was developed to fill this void.
[0008] Oral syringes are manufactured in a variety of sizes with differing tip
and
plunger configurations. Moreover, oral medications are commonly provided in
bulk
form in variously sized bottles or containers having threaded screw caps that
must be
removed and replaced between uses. Additionally, in-patient medical facilities
such
as hospitals are moving toward electronic prescription ("e-prescription")
systems
which use computer systems to create, modify, review, and/or transmit
medication
prescriptions from the healthcare provider to the pharmacy. While e-
prescribing
improves patient safety and saves money by eliminating the inefficiencies and
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inaccuracies of the manual, handwritten prescription process, any syringe fill
automation system suitable for use in a hospital setting must interface with
an
existing e-prescription system (which records and transmits prescriptions to
the
pharmacy), and must be capable of filling prescription orders in a just-in-
time
environment.
[0009] Given the diversity of oral syringes and medicines available, any semi-
automated (or fully-automated) system will need sufficient dexterity to
manipulate all
the myriad prescription bottles containing the pharmaceuticals to be dispensed
as well
as variously sized oral syringes, bringing them together in a controlled
environment to
quickly and accurately fill and label each syringe and to verify its work as
it proceeds
in order to avoid errors in the process. Such a system would need to be
reliably
constructed so as to minimize downtime, quickly take and fill orders, be easy
to clean
and capable of maintaining an environment free from cross contamination. Such
a
system would also need to be able to interact with a human operator at
multiple points
in the operation.
[0010] The present inventors herein provide a semi-automated system suitable
for use
in a hospital setting for filling patient-specific doses of liquid medications
to be
administered by oral syringes on a just-in-time basis, as well as an automated
alternative. The system enables hospital pharmacists to simplify and
streamline their
task, increasing the number of prescriptions that can be filled in a day,
improving
patient safety and care by minimizing medication errors and the consequences
that
ensue.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The objects, features, and advantages of the present invention will
become
apparent from the following detailed description of the preferred embodiments
and
certain modifications thereof when taken together with the accompanying
drawings in
which like numbers represent like items throughout and in which:
[0012] FIG. 1 is a flow chart of the overall method of the invention.
[0013] FIG. 2 is a perspective view of the entire pharmacy automation system
100
according to an embodiment of the invention.
[0014] FIG. 3 is a more detailed flowchart of the substeps of the batch
fulfillment
process 750 of FIG. 1.
[0015] FIG. 4 is a more detailed block diagram of the medication container
orientation and log-in process 720 of FIG. 1.
[0016] FIG. 5A is a composite view of an adapter cap 210 according to an
embodiment of the present invention.
[0017] FIG. 5B is a side view of an adapter cap 210 with tether according to
an
embodiment of the present invention.
[0018] FIG. 5C is a side view of an adapter cap 210 with tether according to
an
embodiment of the present invention with the syringe in place.
[0019] FIG. 6 is a perspective view of an exemplary vision inspection station
6.
[0020] FIG. 7 is an enlarged perspective view of a semi-automated syringe fill
station
for filling the syringes S, shown with optional capping capability.
[0021] FIG. 8 is a top cross-section of an exemplary syringe in-feed
mechanism.
[0022] FIG. 9 is a composite view of the syringe gripping arms 110, 111 and
112
terminating in a pair of fork shaped fingers 120 that form a horizontally
oriented "V"
shaped opening.
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[0023] FIG. 10 illustrates an embodiment of the syringe gripping arms 111 and
its
drive mechanism.
[0024] FIG. 11 is an enlarged perspective view of an automated capper 147 and
inclined capping chute 149.
[0025] FIGs. 12 and 13 illustrate an exemplary control system architecture for
the
system 100 of FIGs. 2-11.
[0026] FIG. 14 illustrates another embodiment of the system 100 which includes
a
first robot arm 875 and a second robot arm 876 as indicated.
[0027] FIG. 15, 16 and 17 show a perspective, top cross-section and end cross-
section, respectively, of an alternate embodiment of the syringe in-feed
mechanism.
[0028] FIG. 18 is a perspective view of a simplified filling system with
manually-
adjustable medicine container grippers.
[0029] FIG. 19(A-C) shows a perspective, top cross-section and end cross-
section,
respectively, of a syringe in-feed pick and place mechanism that employs a
carriage
mounted grip arm apparatus
[0030] FIG. 20 is a flow diagram illustrating the method of use of the
simplified
embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0031] For the purposes of promoting an understanding of the principles of the
invention, reference will now be made to the exemplary embodiment illustrated
in the
drawings and described below. The embodiment disclosed is not intended to be
exhaustive or limit the invention to the precise form disclosed in the
following
detailed description. Rather, the embodiment is chosen and described so that
others
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skilled in the art may utilize its teachings. It will be understood that no
limitation of
the scope of the invention is thereby intended. The invention includes any
alterations
and modifications in the illustrated device, the methods of operation, and
further
applications of the principles of the invention which would normally occur to
one
skilled in the art to which the invention relates.
[0032] The present invention includes both the system hardware as well as the
process for preparing and tracking prescriptions of oral syringes by a series
of
integrated manual and automated steps with respect to preparing the syringe
and the
bulk medicine, and subsequently bringing the series together for filling the
former
from the latter. The invention relies on a conventional network architecture
which
includes a local OSPS (Oral Syringe Packaging System) computer. The OSPS
computer is interfaced to a hospital host computer and receives oral syringe
prescription instructions there from. In the majority of circumstances
physicians
submit prescriptions for oral syringes electronically to the hospital host
computer and
these prescriptions are communicated to the OSPS computer for fulfillment. The
interface serves to parse/extract those oral medication prescriptions from all
prescriptions submitted.
[0033] The local OSPS computer is programmed to know what must occur at each
station and monitors to ensure that each step of the process is completed
satisfactorily
and that all decision rules are complied with. The local OSPS computer
software
implements a Medication Container Orientation and Log-In Process for semi-
automated preparation and storage of bulk medicine containers to be used in
filling
and packaging oral syringes, and a Batch Fulfillment Process for semi-
automated
filling and packaging of oral syringes using the stored bulk medicine
containers. In
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general terms, the semi-automated Medication Container Orientation and Log-In
Process comprises the following steps:
a. Pharmacy technician (operator) removes the manufacturer's cap from bulk
medicine container received from the pharmaceutical manufacturer and replaces
the cap with an adapter cap (described below);
b. Software guides operator to scan the manufacturer's barcode label;
c. Software automatically prints a new unique adapter cap 2D barcode label and
that label is attached to the adapter cap (as an alternative, the adapter cap
can be
provided with a pre-printed barcode label);
d. Software guides operator to rescan the manufacturer's barcode on the
container label and the 2D barcode on the adapter cap;
e. If scanning checks, software guides operator to place medication container
in a
particular (logged) storage facility location.
[0034] The semi-automated Batch Fulfillment Process comprises the following
steps:
a. Software guides operator to retrieve medication container from particular
(logged) storage facility location;
b. Operator loads medication container into system;
c. 2D barcode on the adapter cap is scanned to make sure that all medication
issues relating to that medicine container have been addressed, including
refrigeration, expiration and light-sensitive storage;
d. Software guides operator to pick a syringe;
e. Software automatically prints label for the syringe;
f. The label is rescanned to ensure that the information is correct;
g. Operator places the syringe in the fixture at the syringe labeling station
where
the pre-printed label is attached to the syringe;
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h. Operator scans the 2D barcode on the syringe at the fill/cap station.
i. Operator positions the syringe at the fill/cap station;
j. System/software automatically fills the syringe from medicine in medication
container and caps the syringe;
k. Operator scans the syringe at the volume/weight check station;
1. System/software automatically inspects the syringe for proper weight or
volume;
m. System/software automatically prints bag that the syringe will be packaged
in;
n. Software automatically scans the printing on the bag to make sure that it
is
correct;
o. Operator places the syringe in the bag at the bagging station, and the
system
confirms that the syringe was placed in the bag, and seals the bag with the
syringe in it.
[0034] All medication containers and medicines in those containers that have
been
logged in, each size syringe, each size adapter cap, syringe labels, bags, ink
cartridges, etc. are automatically inventoried. As an item is used or
consumed, an
accounting of the amount of that item remaining is maintained. Track, Trace
and
Validation software monitors the entire process from the prescription approval
by the
pharmacist, log-in of the medication container through each step of the
packaging
process.
[0035] FIG. 1 is a more detailed flow chart of the overall method of the
invention.
The following method steps are performed semi-automatically with some manual
intervention by or interaction with an operator for filling patient-specific
oral syringes
on a just-in-time basis. Note that "semi-automatic" necessarily entails manual
intervention/interaction which has a propensity for introducing mistakes. The
present
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method and apparatus is specifically designed to avoid mistakes and maintains
comprehensive track-and-trace validation of each manual step:
[0036] At step 705 a physician writes an oral medicine prescription which is
electronically entered into existing hospital host computer (as all
prescriptions are so
logged).
[0037] At step 710 the existing hospital host computer communicates the oral
medicine prescription to the hospital pharmacy for approval. A pharmacist will
typically review it.
[0038] If approved, then at step 715 the prescription is transmitted the local
computer
of the OSPS (Oral Syringe Packaging System) of the present invention. The oral
syringe prescription is added to a batch fulfillment queue at the local OSPS
computer.
As described below the queue is multi-sorted so that all prescriptions for a
particular
type of medicine (e.g., Acetaminophen, cough syrup, etc.) can be fulfilled
together,
and at periods throughout the day an operator may run a batch fulfillment
queue
(typically batches are run a few times each day).
[0039] At commencement of batch fulfillment, the OSPS system preferably guides
the operator in retrieving the appropriate medication container from OSPS
storage (as
will be described). Such guidance presupposes that a library of medicine
containers is
maintained and that each such medicine container be logged into the OSPS
system so
that its location and contents are known to the local OSPS computer.
Consequently,
as a precursor to batch fulfillment each new medication container is logged
into OSPS
storage by a barcode, RFID scan or similar identification scan (e.g., of the
manufacturer's barcode). The manufacturer-applied cap must also be replaced by
an
adapter cap (to be described) which is separately labeled. All this occurs at
step 720.
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[0040] At step 725 based on the medication container login, the OSPS system
guides
the operator in properly storing the new medication container. The OSPS system
(as
described below) includes separate storage locations for three types of
medication
containers: Location 1 - No Special Handling of container; Location 2 -
Refrigeration
Required; Location 3 - Light Sensitive medication container. Each storage
compartment within each location may be enclosed by a magnetically-actuatable
door
so that access to each location may be electronically controlled by the local
OSPS
computer. Alternately, each storage compartment within each location may be
illuminated by an LED light, so that access to the proper location may be
electronically guided by illumination of the proper LED. As another
alternative, each
storage compartment within each location may be equipped with a light curtain
so that
the local OSPS computer can monitor access to the proper location. All these
and
other suitable forms of user-guidance/selection are considered to be within
the scope
and spirit of the present invention. In all such cases, the end result is an
OSPS storage
library of different oral medicines in their bulk containers, each properly
logged in
and stored in its corresponding storage location 1-3.
[0041] Similarly, at step 740 an inventory of packaging materials is
maintained,
including empty syringes in an array of sizes, syringe caps, labels (for
barcodes), and
iffl( foil printer ribbon.
[0042] In support of the OSPS system, at step 730 a comprehensive medication
database is maintained at the OSPS computer.
[0043] The OSPS medication database includes the following:
1. Medication Information.
a. Medication name.
b. Manufacturers barcode number.
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c. Written information that corresponds to manufacturer's barcode number.
d. Whether medication needs to be shaken, if so the frequency and duration
between fills.
e.Whether the medication needs to be refrigerated, if so refrigeration policy
required
f. Whether the medication is light sensitive, if so light sensitive protection
required.
2. Product information (pertaining to individualized medication containers
logged in).
a. The OSPS 2D barcode number assigned to that specific container
b. Fill size of that container in cubic centimeters (cc).
c. Current amount of product remaining in that container after deducting
for previous fills extracted by the syringes.
d. Manufacturer's Expiration Date
e. Date the medication container is logged-in at the Medication Container
Log-In Orientation System.
f. Pharmacy Policy Expiration Date: Container open date plus number of
days before container expires (determined by pharmacist).
g. Effective Expiration Date. This is the soonest of the manufacturer's
expiration date or the date that the container is open plus the number of
days that the open container will expire. (Pharmacy Policy Expiration
Date).
[0044] Given all of the foregoing, at step 750 an operator may at any
convenient time
commence the batch fulfillment process. The more detailed substeps of the
batch
fulfillment process 750 are illustrated in the block diagram of FIG. 3.
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[0045] After each oral syringe has been filled and package during batch
fulfillment
750, it is inspected and either rejected at step 760 or approved at step 770.
[0046] The above-described method is herein implemented in several detailed
embodiments of a system suitable for preparing patient-specific oral syringe
doses.
Various alternate embodiments of the invention may omit selected steps (and
their
performance station) where such is/are not required. The needs of the
operating
institution and the cost aspect of automating certain steps may direct which
steps/stations (if any) are to be performed manually by an operator
interfacing with
the apparatus and which may be automated. A presently-preferred embodiment is
described below with reference to FIG. 2.
[0047] As seen in FIG. 2, the pharmacy automation system 100 for packaging
oral
syringes generally comprises a standalone Medication Container Login &
Orientation
Station 1, with an included array of adapter cap storage bins 12. In addition,
a
proximate or remote Storage Facility 2 is provided for storing all logged in
medication containers, with separate locations for the three types of
medication
containers: (a) Location 1 - No Special Handling of container; (b) Location 2 -
Refrigeration Required; (c) Location 3 - Light Sensitive medication container.
[0048] A storage bin 3 is provided for storage of empty syringes, and a
syringe label
printer and labeler station 4 is provided next. This is followed by a syringe
fill/cap
station 5, then a check weight and/or volume station 6, and lastly a bag
printing and
sealing station 7. The purpose and function of each of the foregoing stations
1-7 will
become clearer in the context of a description of the Medication Container
Orientation
and Log-In Process (step 720), and Batch Fulfillment Process 750.
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Medication Container Orientation and Log-In Process (step 720)
[0049] The OSPS system guides the operator in properly equipping and storing
each
bulk medication container.
[0050] As shown in FIG. 4, at step 900, medication containers are received
from a
contract packager or pharmaceutical manufacturer.
[0051] At step 910, medication containers are delivered to the OSPS Medication
Container Login & Orientation Station 1 (FIG. 2).
[0052] At step 915 the pharmacist and operator logs into the local OSPS
computer.
[0053] At step 920 caps on medication containers are manually removed and
discarded.
[0054] At step 925 the manufacturer-provided medication container barcode is
scanned. Variable information is entered into the system by the pharmacy
technician
[0055] At step 926, the OSPS local computer instructs the operator which of
the
adapter caps to select for recapping the medication container. As above, each
adapter
cap storage compartment 12 may be enclosed by a magnetically-actuable door so
that
access to each location may be electronically controlled by the local OSPS
computer,
or illuminated by an LED light, or equipped with a light curtain so that the
local
OSPS computer can monitor access to the proper location. All these and other
suitable forms of user-guidance/selection are considered to be within the
scope and
spirit of the present invention.
[0056] At step 930, the medication container is recapped with the adapter cap.
[0057] At step 935, the labeler shown at the Medication Container Login &
Orientation Station 1 generates a 2D barcode label which includes the location
that
the medication container is to be stored at. The 2D bar code is placed on the
adapter
cap at step 945.
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[0058] At step 940, the bar code label is automatically inspected immediately
after
printing to verify that its contents are correct and the bar code ID is stored
in the
OSPS database.
[0059] At step 950, the 2D bar code placed on the adapter cap and the
pharmaceutical
manufacturer's barcode are scanned using a scanner resident at the Medication
Container Login & Orientation Station 1.
[0060] At step 955 all general and container specific information is recorded
in the
local OSPS computer database, including the storage location of the bulk
container.
[0061] At step 960, the OSPS local computer assigns an expiration date to the
medication container.
[0062] At step 965, the operator manually stores the container in the location
specified by the OSPS local computer. If the container is to be stored in
light
protected storage 2(c), an optional log-in/log-out control system may be used
to verify
if the container was stored properly. This way, if the container is outside of
the light
protected storage area more than a specific number of minutes the OSPS local
computer will not permit the syringe to be filled from that container.
[0063] At step 970 if the container is to be stored in the refrigerator, an
optional log-
in/log-out control system and procedure is available to verify if the
container was
refrigerated satisfactorily. This way, if the container is outside of the
refrigerated
storage area more than a specific number of minutes the OSPS local computer
will not
permit the syringe to be filled from that container, and will alert the
Pharmacy
Technician to remove and discard that container.
[0064] At step 975 if the container is to be stored in a light protected
storage area, an
optional log-in/log-out control system and procedure is available to verify if
the
container was stored appropriately. This way, if the container is outside of
the light
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protected storage area more than a specific number of minutes the OSPS local
computer will not permit the syringe to be filled from that container, and
will alert the
Pharmacy Technician to remove and discard that container.
Batch Fulfillment Process 750
[0065] With reference both to FIGs. 2-3, at step 800 a pharmacist must log
into the
OSPS local computer to use the system.
[0066] At step 810, the pharmacist selects the desired OSPS operational mode.
Currently four modes of operation are envisioned:
1. Patient Specific ¨ Hospital Directed
a. The Doctor writes the prescription and enters it into the Hospital Host
Computer System.
b. The prescription is reviewed by the Pharmacist. If it is okay, the
prescription is sent to the Local OSPS Computer where it is batched.
Batches will typically be run 2-3 times a day.
c. The Local OSPS Computer first sorts all the batched prescriptions in
alphabetically order by name.
d. The prescriptions are then sorted by size of fill from smallest to
largest.
The total amount of each medication required for that batch run is
totaled. The Local OSPS Computer checks to ensure that there is a
sufficient amount of product for each medication required to complete
the batch.
2. STAT (Rush Order) ¨ Hospital Directed
a. The Doctor writes the prescription and enters it into the Hospital Host
Computer System.
b. The prescription is reviewed by the Pharmacist.
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c. The prescription order indicates that the prescription needs to be
administered soon to the patient.
d. If the OSPS System 100 is currently being used, the Pharmacist can
decide to either stop all current prescriptions being packaged or wait
until completion. Either way, the Local OSPS Computer processes the
singular rush order.
3. Medication Specific ¨ Pharmacy Directed
a. This mode allows production-scale filling of a large number of
syringes with the same medicine and the same fill volume. Some
medication will need to be inventoried in advance of the Doctor's
prescription. This mode provides the pharmacist with the opportunity
to package certain liquid oral products such as vitamins and popular
standard dose medications on a more cost-effective basis than buying
them already pre-packaged.
b. The Pharmacist will manually enter in a production order for the
medication into the Local OSPS Computer.
c. The Pharmacist will specify the medication name, size of fill, the
information that will go onto the syringe label, the information that
will go onto the bag that the syringe is packaged in, and the amount of
syringes that are to be packaged for that production run.
4. Manual ¨ Pharmacy Directed
a. Not all hospitals have an existing electronic prescription system
installed that permits the electronic transmission of the Doctor's
prescription to the hospital pharmacy. Consequently, the OSPS can be
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operated on a manual basis whereby the prescriptions are entered into
the system under the Pharmacist's supervision.
[0067] One skilled in the art should understand that other operational modes
include a
Patient Priority mode in which all medications/oral prescriptions for a
specific patient
are processed sequentially before moving on to the next patient. The invention
is
herein described in the context of Patient Specific ¨ Hospital Directed Mode
which is
the most typical mode of operation.
[0068] At step 815 an operator (pharmacy technician) logs in.
[0069] At step 820 the OSPS local computer directs the operator to select the
appropriate medicine container from Storage Facility 2, and an appropriate
syringe
from storage bin 3 (FIG. 2).
[0070] At step 825, the operator retrieves the appropriate medicine container
from
Storage Facility 2 (under system guidance) and installs it at the syringe
fill/cap station
5.
[0071] At step 826, the barcode on the adapter cap is scanned to make sure
that all
medication-related issues have been satisfied (refrigeration, light-sensitive
storage,
expiration, etc.).
[0072] At step 830, the operator retrieves the appropriate size syringe from
storage
bin 3.
[0073] At step 835, the operator prints a syringe label at syringe label
printer and
labeler station 4 indicating in both human and machine readable forms (i.e.
text,
barcode or RFID tag) the type, concentration, expiration, etc. of the
medication it will
contain. The label includes a bar code (preferably a 2D barcode though other
labels
such as RFID may be used. The label is adhered to the syringe barrel.
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[0074] At step 840, the operator positions the empty syringes at the syringe
fill/cap
station 5.
[0075] At step 845, the syringe is filled and (optionally) capped at the
fill/cap station
5. The OSPS system automatically fills the syringe with the medicine by
insertion of
the syringe nozzle into the adapter cap, and withdrawal of the plunger. The
system
optionally caps the syringe and presents it to the operator.
[0076] At step 850, the operator positions the filled syringe at check weight
and/or
volume station 6 and at step 855 the syringe is inspected for correct weight
or volume.
These actions are logged.
[0077] At step 860 a syringe bag is printed/barcoded at bag printing and
sealing
station 7, and at step 865 the system verifies the bag is printed correctly.
If so, the
operator is permitted to insert the filled/capped syringe into the
barcoded/labeled bag.
[0078] At step 870 the syringe bag is sealed at the bag printing/sealing
station 7. The
packaged syringe can then be distributed to the patient.
[0079] At each step of the above-described process the OSPS system employs
comprehensive track-and-trace inspection/validation of the syringe and, when
required, the medication bulk container, to insure that the packaging process
is
occurring correctly and to compile an audit trail of the current and past
locations (and
other information) for each syringe.
[0080] If the process fails then as seen at step 760 of FIG. 1 the syringe or
medicine
container is rejected. If the process occurs correctly then as seen at step
770 of FIG. 1
the syringe is approved and available for distribution. The core method and
possible
variations are herein implemented in several detailed embodiments of a system
suitable for preparing single oral syringe doses. Various alternate
embodiments of the
invention may omit selected steps (and their performance station) where such
is/are
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not required. The needs of the operating institution and the cost aspect of
automating
certain steps may direct which steps/stations (if any) are to be performed
manually by
an operator interfacing with the apparatus and which may be automated.
[0081] Referring back to FIG. 2, each station of the pharmacy automation
system 100
for oral syringes is described below in more detail.
Medication Container Login & Orientation Station 1
[0082] The first station in the process of the present invention is Medication
Container Login & Orientation Station lat which the bulk medicine is prepared
for
use in the system 100. Medication Container Login & Orientation (MCLO) Station
1
is a standalone desk unit that provides a facility for inputting needed
information into
the OSPS database via scanner 95 and data entry terminal 96, apply barcodes as
needed via label printer 97, decap bulk containers 104 (see FIG. 5) at
decapping
station 93, and refit them with an adapter cap (as will be described) at
capping station
94. All of the scanner 95, data entry terminal 96, label printer 97, decapping
station
93, and capping station 94 are commercially available components. MCLO Station
1
is standalone so that it can be positioned as desired. Medicine for oral
syringes is
provided in liquid form in a container with a manufacturer-applied safety cap.
An
object of the present invention is to be able to insert a syringe nozzle into
the
containers to withdraw a proper dose of medicine into the syringe. As
indicated, this
requires removal of the manufacturer's cap and replacement with a specialized
adapter cap having a penetrable seal for insertion of an oral syringe nozzle
(or
alternatively, manufacturer's conforming their packaging such that they
provide their
products to hospitals with an adapter cap pre-applied).
[0083] FIG. 5 is a composite view of an adapter cap 210 according to the
present
invention which is adapted to fit a variety of medicine bottle types and
sizes. Despite
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the variability in OEM medicine bottle types and sizes, the adapter cap 210
affords a
consistent external configuration and dimensions, providing an interface
between any
standard medication container with the present OSPS system 100. It also
facilitates
insertion of the oral syringe nozzle into those standard medication
containers. As
described in detail below, each adapter cap 210 is an annular member defining
an
internal barrel with an aperture 223 at one end, an elastomeric seal 225 over
the
aperture for penetration by the nozzle of a syringe S, and opposing flanges
214
separated by a groove 220. An overcap 229 may be provided as a protective
cover to
the adapter cap 210. The opposing flanges 214 encircle the cap body and define
the
annular groove 220 there between for positive engagement by the dispensing
apparatus 100 so as to enable syringe filling operations. All adapter caps 210
are
barcoded in advance with a unique identifier number. If desired, one of the
flanges
214 may be defined with a peripheral flat area for displaying a bar code 290
or,
alternatively, bar code 290 may be located atop the uppermost flange 214 (on
the top
of the cap). The other flange 214 may also be defined with a peripheral flat
area for
indexing the orientation of the medicine container 104. One flat area enables
orientation of the adapter cap 210 in a known position. The other flat area
better
presents the identifying information such as a barcode for automated sensing
or
reading of the information. The flat areas also enable or facilitate automated
or
manual tightening of the threaded connection between the neck of the container
104
and the cap 210. The barcode flat and the orientation flat are preferably
parallel to one
another on opposite sides of the adapter cap 210 and are also longitudinally
offset so
as to be distinguishable. The known relationship between the orientation flat
and
barcode flat facilitates manual or automatic of container positioning and
orientation
with the dispenser and automatic sensing of the same. In addition to or in
place of
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one or more of the flats, strategically located holes or recesses in the top
surface of the
cap may be provided.
[0084] One skilled in the art should also recognize that identifying
information can be
expressed by barcode printing or labeling directly on the cap 210 or the cap
may serve
as a vehicle to carry an "RFID" tag. The plastic resin used to mold the cap
may be
formulated to contain an ingredient that would allow direct printing on the
cap with
either ink or a laser without the need for or use of adhered paper or similar
labels. The
top of the cap may also be used to affix, print or etch the barcode either by
direct
printing or adhesive label.
[0085] With reference to the middle inset of FIG. 5, an exemplary embodiment
of an
adapter cap 210 is depicted. Adapter cap 210 comprises a generally annular cap
body
preferably formed of a polyethylene, polypropylene, polyvinyl chloride or a
similar
synthetic polymer. The cap body is formed with an annular outer wall 221 for
supporting the cap 210 against the outer surface of the medicine container and
supporting opposing flanges 214, and a coaxial annular inner wall 222 for
supporting
the cap 210 against the inner surface of the medicine container and supporting
and
centering the elastomeric seal 225 within the neck of the medicine container.
The
flanges 214 may be hollowed as shown to conserve material, solid, or may be
open
around their periphery. Also, the flanges 214, annular outer wall 221 and
coaxial
annular inner wall 222 may be integrally formed (such as by molding), or may
be
separate but attached as shown. The annular inner wall 222 is open at one end
and
constricted at the other by an inwardly projecting annular flange 229 which
defines a
typically circular aperture 223 through the cap body 220 for access to the
contents of
the medicine container 104 as will be described. The elastomeric seal 225 is
mounted
in the aperture 223 to create a sealed but penetrable passage for the syringe
S nozzle.
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[0086] The outer wall 221 of the adapter cap 210 may be defined by a simple
inwardly-threaded connection for screw-insertion onto the threaded container
104
neck. However, the great variety of manufacturer thread pitches and container
104
neck sizes weighs in favor of a more universal-fit adapter cap 210. This is
possible by
providing the outer wall 221 of the adapter cap 210 with a series of
integrally formed
inwardly-directed circular gripping ribs 242 for gripping the neck of a bottle
104 by
its threads. As the neck of a bottle 104 is forced into the central void, the
ribs 242
engage the threads on the outside of the neck of the bottle and flex to permit
the
threads to pass. Once past, the ribs 242 spring back toward their original
position and
press against the neck to engage the threads and secure the adapter cap 210 to
the
container 104. The variable size of the central void due to the flexure of the
resilient
ribs 242 permits the adapter cap 210 to accommodate some variation in outside
neck
diameter and thread finish, and create a fluid-tight seal without the need for
a specific
thread pitch. The coaxial annular inner wall 222 abuts the interior of the
container
104 neck, centers the adapter cap 210, and centrally supports the elastomeric
seal 225
within the neck. If desired, the annular inner wall 222 may be separately
formed as an
elastomeric insert to effectuate a fluid seal between the inner wall 222 and
the smooth
inside surface of the neck of the bottle 104. Similar to the outer wall 221,
inner wall
222 may also be formed with a plurality of outwardly-directed annular ribs or
wipers
to improve the seal, or may contain an outwardly-facing 0-ring for the same
purpose.
In this case inner wall 222 may be a separate element inserted into the outer
wall 221
of the cap body and secured in place by ultrasonic welding or otherwise.
[0087] To improve the resiliency of the inner wall 222 and/or outer wall 221
either/or
can be segmented by notches partially interrupting the continuous walls,
thereby
forming several (preferably eight) "spring finger" segments attached to the
body and
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arrayed about its axis. The bottom inset of FIG. 5 illustrates this axial
array of
segments 227 which, if formed in outer wall 221 effectively snap over the
threads on
the exterior of the neck of the medicine container 104. The serrated segments
227 are
first to advance down the threaded neck and align the neck for a better seal
with the
adapter cap 210 body. The same can be done on the inner wall 222 to improve
resiliency, again forming several (preferably eight) "spring finger" segments
to abut
the interior of the medicine container 104 neck.
[0088] Even with the resilient ribs 242 and segments 227 each adapter cap 210
won't
fit all sizes of container 104, and so it is envisioned that several
(approximately eight)
sizes of adapter cap 210 will be needed.
[0089] The elastomeric seal 225 is fitted within the aperture 223 of the
flange of inner
wall 222. In its simplest form the elastomeric seal 225 may be a resilient,
penetrable
membrane with a small hole or slot (such as a pinhole) punched at its center,
and
preferably formed of silicone or other rubber. The hole in the seal 225
expands as the
tip of a syringe S is inserted to permit pressurization of the container 104
and/or
filling of the syringe (by vacuum) as described below. On withdrawal of the
syringe
tip the resilient elastomeric seal 225 returns to its original shape closing
the hole and
preventing leakage of the fluid contents of the bottle 104. However, a flat
elastomeric
seal 225 with a hole or slot has been found to drip slightly.
[0090] To prevent dripping, a preferred embodiment of the elastomeric seal 225
is
shown in the right-most inset of FIG. 5, which improves the engagement with
the
nozzle of the syringe S. Seal 225 is formed with a hollow cylindrical section
231
circumscribed by a flange 232 for mounting within (or to) the coaxial annular
inner
wall 222 of the adapter cap 210 body. The cylindrical section 231 leads to a
pronounced duck-bill protrusion 233 that tapers to a distal tip, with aperture
223
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(preferably slotted) continuing out through the duck-bill protrusion 233. The
duck-
bill protrusion 233 serves as a flap valve against the nozzle of the syringe S
and
expands to receive the nozzle of the syringe S. The duck-bill configuration is
advantageous because it creates a seal around the syringe S nozzle prior to
the nozzle
forcing open the duck bill slit. Likewise, upon exit, the duck-bill closes
prior to the
syringe nozzle breaking its seal against the interior. This tends to self-
relieve pressure
and prevent dripping.
[0091] The adapter cap 210 is typically applied to the container 104 as shown
at left
and inserted into the Medication Container Login & Orientation Station 1 (FIG.
1) in
an upright orientation as shown. The adapter cap 210 allows the attached
medicine
container 104 to be manually staged by the upper and lower flanges 214 and
thereby
gripped by the Medication Container Login & Orientation Station 1 in order for
the
container 104 to be to shaken (when needed) and inverted 180 degrees into a
fill
position (as in FIG. 5 middle inset) for upward insertion of the syringe S.
Inversion
allows the fluid contents to be collected at the adapter cap 210 under force
of gravity.
[0092] Referring back to FIG. 2, at MCLO Station 1 a number of bins 12 are
provided
for storing various sizes of adapter caps 210 as needed to fit all standard
container
sizes. As described above in steps 910 through 965 (FIG. 4), OSPS system 100
guidance for the manual container 104 selection process and return process
(along
with the adapter cap 210 and syringe S selections) is "system-guided" as
described
above. Each adapter cap storage compartment 12 may be enclosed by a
magnetically-
actuable door so that access to each location may be electronically controlled
by the
local OSPS computer, or illuminated by an LED light, or equipped with a light
curtain
so that the local OSPS computer can monitor access to the proper location.
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[0093] OSPS system 100 guidance for the manual container 104 selection process
employs a software module that relies on all three of the information
components
stored in the OSPS system database: 1) product information from the
manufacturer or
other external sources describing the medicines and their containers (size,
dose,
handling requirements, etc.); 2) prescription-specific information from the
hospital
identifying the prescription details and patient to receive it; and 3) OSPS
runtime
information such as the amount of medicine previously taken from a given bulk
container. Specifically, patient-specific information from the hospital
identifying the
prescription details is compared to product information from the manufacturer
or
other external sources to determine the appropriate medicine to retrieve. The
software
module ascertains from the patient-specific information the appropriate amount
of
medicine to retrieve. This is compared to OSPS runtime information (the amount
of
medicine previously taken from the bulk containers 104 to determine the
specific
container 104 to retrieve. The location of that container 104 is ascertained
from the
scan of the container 104 and pre-labeled adapter cap 210 at scanning station
95, and
the ensuing storage location in Storage facility 2 which was assigned via OSPS
system 100 guidance. The exact container 104 location is presented to the
operator
who retrieves the container from the Storage facility 2. Again the Storage
facility 2
may be fitted with magnetic doors, LED lamps or light curtains either to
compel the
proper selection, draw the operator's attention to it, or provide an alarm in
case of a
wrong selection. In still other embodiments the container 104 selection may be
semi-
automated so that the appropriate container is ejected to the operator under
control of
the OSPS computer.
[0094] In operation, and as described above with regard to FIG. 4 (medication
container orientation and log-in process step 920), the OEM caps on medication
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containers 104 are manually removed and discarded at decapper 93, the OSPS
local
computer instructs the operator which of the adapter caps in storage 12 (FIG.
2) to
select for recapping the medication container 104 (step 926), the operator
retrieves the
proper adapter cap 210 and applies it at capper 94. The labeler 97 generates a
2D
barcode label which includes the location of Storage facility 2 that the
medication
container 104 is to be stored at. The operator places the 2D bar code on the
adapter
cap, and the 2D barcode on the adapter cap is scanned by scanner 95. All
general and
container specific information derived by scanning or supplemental data entry
at data
entry station 96 is recorded in the local OSPS computer database, including
the
storage location of the bulk container 104 in Storage facility 2 and the
expiration date
of the medication container. The operator then manually stores the container
in the
Storage facility 2 assigned by the OSPS computer. If the container is to be
stored in
light protected storage 2(c) or refrigerated storage 2(b) the track-and-trace
software
ensures compliance. Later, when needed to fulfill a batch of oral syringe
prescriptions an operator will select (with system guidance) a container 104
of the
desired medicine from the Storage facility 2 with adapter cap 210 applied,
scan it at
scanning station 162, and load it into a product interface 81 (FIG. 7) at the
fill/cap
station 5. The medicine is verified by the scanning as to proper content,
available fluid
volume and other attributes before being loaded at the product interface 81.
[0095] The second station in the packaging process according to the present
invention
is a storage bin 3 for storage of empty syringes. The syringe storage 3
preferably
incorporates a separate syringe compartment for each size of syringe that the
system
anticipates needing in the course of a production run. Again, this manual
selection
process (along with other manual selections) is "system-guided" as defined
above in
respect to syringe S selection as well. As with medicine container 104
selection, the
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software module ascertains from the patient-specific information the
appropriate dose
of medicine to determine the specific syringe S size to retrieve. The location
of that
syringe S is ascertained from the database, and the exact syringe S location
in syringe
storage 3 is presented to the operator who retrieves it from the syringe
storage 3.
Again the syringe storage 3 may be fitted with magnetic doors, LED lamps or
light
curtains either to compel the proper selection, draw the operator's attention
to it, or
provide an alarm in case of a wrong selection. In still other embodiments the
syringe
storage 3 selection may be semi-automated so that the appropriate syringe S is
ejected
to the operator under control of the local OSPS computer. The selection
software
module calculates the most appropriate syringe S size based on the required
prescription information dosage, the known volume of the syringe selections
(the
following standardized oral syringe sizes: 0.5m1, lml, 3m1, 5m1, 10m1, 20m1,
35m1,
60m1), identifies the syringe size to accommodate the fill volume of the
prescription,
and presents the syringe storage 3 location to the operator who retrieves the
syringe
from the proper magazine (with help of LED indicator, magnetic door, light
curtain,
ejection mechanism or otherwise).
[0096] The third station is a flag label printer/applicator 4. After
retrieving the
syringe S the operator inspects it for defects and, finding none, inserts the
syringe into
syringe label printer 4, which is a commercially available flag label
printer/applicator.
As described above relative to FIG. 3 (step 835), the operator prints a
syringe label at
syringe label printer 4. The labeler is in communication with the local OSPS
computer and automatically prints self-adhesive labels bearing information
regarding
the prescription such as the eventual contents of the syringe (medicine type,
concentration, dosage, expiration, scheduled administration, etc.) and its
intended
recipient (name, room number, etc.) along with a bar code identifying a
central record
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of this information in the OSPS database. The label includes a 2D barcode
though
other labels such as RFID may be used. The label is adhered to the syringe
barrel
using known application methods. In one such embodiment the label is supported
by
hinged arms of the applicator and held by vacuum pressure while the applicator
advances to envelope the syringe barrel with the hinged arms coming together
to join
the label as a flag to the barrel of syringe S. A portion of the label around
the barrel
must be transparent to permit dosage markings of the syringe to be clearly
visible.
The operator positions the empty syringe S (step 840) at the syringe fill/cap
station 5.
[0097] The fifth station is the syringe fill/cap station 5 for filling the
syringes S, and
with optional capping capability. A scanner is resident at the syringe
fill/cap station 5
to automatically scan the machine readable labels on the surface of the
container 104,
cap 210 and loaded syringe S to again verify that the selected items are
correct. The
operator loads the container 104 into the fill station at a manual product
interface 81
and manually loads the oral syringe S into a loading carriage 70 (FIG. 7) of
the
syringe fill/cap station 5. The product interface 81 engages the container 104
and
inverts it into a fixed upside down position and orientation (see Fig. 5
middle inset)
for filling of the syringe. The system automatically fills the syringe S with
the
medicine by insertion of the syringe nozzle into the adapter cap 210, and
calibrated
withdrawal of the plunger. The system optionally caps the syringe and returns
it to
the operator.
[0098] The sixth station is an inspection station 6 which comprises a check-
weigh
scale. The operator uses it to weigh and/or inspect the filled syringe S to
verify the
syringe is as labeled, and the System 100 accepts or rejects the
weighed/inspected
syringe. The OSPS software calculates the target weight based on the fill size
in cc's
and multiplies by the specific gravity to derive weight. The specific gravity
of each
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medication is stored in the OSPS database along with the percentage +/- %
deviation
that is acceptable for the actual fill weight. If the actual fill weight is in
the target
range, it is accepted. If not, it is rejected.
[0099] More preferably, inspection station 6 is a vision inspection station
(alone or in
combination with check weigh scale) to ascertain fill volume.
[0100] FIG. 6 is a perspective view of an exemplary vision inspection station
6 in
which syringe fill volume is inspected by a CCD imager 330 that optically
detects by
image analysis if the syringe S plunger is at the correct location, the volume
above the
plunger and below the syringe tip is filled with product, and also checks for
bubbles in
the product. If the syringe volume inspection device 6 determines that the
syringe is
filled to the correct volume with an acceptable amount of bubbles, it will be
accepted.
Otherwise it will be rejected.
[0101] The seventh station is a bag printing and sealing station 7. The
bagging station
7 is a commercially available Hand Load Printer/Bagger for hand load labeling
and
bagging applications. It is networked to the local OSPS computer to
automatically
print the bag that the syringe S will be packaged in. The bag is printed with
information regarding the prescription such as the eventual contents of the
syringe
(medicine type, concentration, dosage, expiration, scheduled administration,
etc.) and
its intended recipient (name, room number, etc.) along with a bar code
identifying the
same content. After printing a bag the system inspects the print on the bag to
make
sure that it is correct. If so, the operator is permitted to place the
filled/capped syringe
S in the bag, the system confirms that the syringe was placed in the bag, and
the bag is
then sealed.
[0102] If all the steps are completed correctly the syringes are distributed
for
administration to the patient.
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[0103] One skilled in the art will recognize that certain steps may be
completed in
various alternate sequences to achieve the same result, and features may be
modified
or eliminated as a matter of design choice.
[0104] With combined reference to FIGs. 1-6 and additional reference to other
drawings a detailed description of an embodiment of the present invention is
herein
provided.
[0105] At initial MCLO Station 1 an operator prepares bulk medicine containers
for
use at the automated syringe fill/cap station 5. Preparation entails applying
an adapter
cap 210 onto the neck of the bottle or container to enable the system to
engage and
manipulate the container 104 during the dispensing process as will be
described.
Again, each adapter cap 210 is pre-labeled with a unique identifying number,
for
example, in barcode format. Preparation of the container 104 also includes
scanning,
verification and recordation of adapter cap 210 information, scanning,
verification and
recordation of container 104 label information including content information
(name,
manufacturer, full volume, concentration, etc.), batch or production
information and
expiration information, and association of the unique adapter cap 210 number
with its
assigned container 104 in a medication track and trace database. Various other
parameters for each medicine can be associated with each record in the
database such
as the maximum flow rate at which a certain medicine can be withdrawn from its
storage container (i.e. to prevent cavitation/inaccurate fills), the storage
temperature
(ambient or refrigerated), the required frequency of shaking/agitation of each
medicine to keep any particulate matter properly suspended/distributed (e.g.
between
each syringe fill dispense cycle or only at the start of a series of syringe
fill dispense
cycles). As an example, each barcode (or possibly RFID tag or other label)
preferably
references the following information:
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= Batch number
= Expiry date
= Storage instructions
= Product name
= Strength
= Name of the active ingredient(s)
= Dose form
= Warning statements
= FDA number
= Product need to be shaken before use? If so, how often?
= Product need to be refrigerated before use? If so, temp?
= Volume of original bulk medication container?
[0106] The information available from the pharmaceutical manufacturer's
barcode
on the medication container varies from manufacturer to manufacturer. The
operator
is prompted to enter any missing data directly into the computer data entry
terminal
96 at MCLO Station 1. The information from the pharmaceutical manufacturer's
barcode label plus the variable information is stored in the medication
container
database which is linked to the medication container by the adapter cap
barcode label.
The adapter cap 210 identifying number is linked to the container 104 to which
it is
attached in the medication track and trace database. It is also important that
each
container 104 is marked in both human and machine readable forms (i.e. text,
barcode
or RFID tag) as to the type and concentration of the medication it contains
along with
various other information, to enable visual inspection.
[0107] The containers/bottles 104 are typically manufacturer-supplied although
custom containers/bottles may be used for purposes of the present system. If
the
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storage containers or bottles 104 are provided by the manufacturer, 20mm,
24mm,
and 28mm neck diameters are typical. The bulk containers may be provided in a
specified, standardized format by the manufacturer, or the medicines may be
refilled
into standardized containers onsite.
[0108] If a custom storage container 104 is used the neck diameter is a
uniform,
known size. In either case, the storage containers 104 may be retained in an
upright or
inverted position and are preferably equipped with adapter cap 210 that allows
dispensing while preventing air infiltration that leads to premature spoilage
of the
contents. Proper adapter caps 210 are either substituted for the
manufacturer's onsite
or supplement the manufacturer's cap.
[0109] With regard to FIG. 2, the container gripping apparatus 81 effectively
flips the
container 104 from the position shown about a 180 degree arc to an inverted
fill
position out front. Once inverted in the fill position, an oral syringe S is
advanced
into the elastomeric seal 225 of the adapter cap 220 and is sealed therein
(see FIG. 5).
The oral syringe may be entirely evacuated such that its plunger is advanced
all the
way into its barrel or the oral syringe may have a calibrated amount of a gas
(such as
air or nitrogen) in front of the plunger in the barrel. The syringe plunger
may be
withdrawn to draw the fluid into the barrel. Where a gas is present in the
syringe, the
plunger may be first advanced so as to force the gas into the container 104.
The
plunger is then withdrawn to draw the fluid into the syringe. Introduction of
the gas
into the container 104 slightly pressurizes the container initially and
prevents the
development of negative pressure within the container which would inhibit
fluid flow.
When the syringe is filled to the proper volume it is withdrawn.
[0110] Referring back to FIG. 2, the operator returns the prepared medicine
container
104 with its adapter cap 210 in the medicine Storage Facility 2 where it
remains until
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called for. The system software monitors the contents of the medicine Storage
facility
2 in terms of both identity of the prepared medicines available to be
dispensed and the
quantity of each medicine. The content of the Storage facility 2 is
continually updated
as the medicine is dispensed and the system is able to predict based on
current
pending prescription and historical dispensing information when the current
available
container of any given medication will be empty so as to advise the operator
to
prepare a replacement quantity of such medicine prior to emptying the existing
container. Medicines exceeding their expiry dates are also identified by the
system to
be discarded by the operator.
[0111] After retrieving the syringe from syringe store 3 of empty syringes S
to be
filled as described above, the operator inspects it for defects and, finding
none, inserts
the syringe into a syringe label printer/applicator 4. The labeler 4 is in
communication with the central controller and prints self adhesive labels
bearing
information regarding the prescription such as the eventual contents of the
syringe
(medicine, dosage, scheduled administration, etc.) and its intended recipient
(name,
room number, etc.) along with a bar code identifying a central record of this
information. The label is printed, scanned (inspected) and, if approved,
applied to the
syringe using known application methods. In one such method the label is
supported
by the hinged arms of the applicator by vacuum pressure while the applicator
advances to envelop the syringe barrel with the hinged arms coming together to
join
the label as a flag to the barrel. A portion of the label around the barrel
must be
transparent to permit dosage markings of the syringe to be clearly visible.
[0112] FIG. 7 is an enlarged perspective view of a semi-automated syringe fill
station
for filling the syringes S, and with optional capping capability. The syringe
S is
manually loaded by the operator into the loading carriage 70 of the syringe
fill/cap
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station 5, preferably with the plunger partially withdrawn from the barrel.
The loading
carriage 70 is a manually-moveable element having starwheel indexer 72 with a
series
of semicircular wells 73 of differing sizes positioned to receive syringes of
various
sizes and a push-handle 74 for pushing each loaded syringe into a loading
position.
After loading the syringe, the operator must position the starwheel indexer 72
so that
the appropriately-sized well engages the syringe. The operator selects the
well 73
corresponding to the particular syringe to be filled. The advancing syringe in
carriage
70 cooperates with the starwheel indexer 72. The cooperation of the advancing
syringe in carriage 70 with rotary starwheel indexer 72 prevents the indeed of
a
wrong-sized syringe, and indexes both the position of the syringe (moving it
90
degrees counterclockwise into the fill position), and the orientation of the
syringe (for
syringes with offset nozzles it indexes the nozzle to the same angular
position when
the syringe is in the fill position). The enlarged inset of FIG. 7 shows an
expanded
cross-section of the internal mechanics of the starwheel indexer 72. With
syringe
loaded into a well of carriage 70, the operator pushes the push-handle 74
which spins
the syringe 90 degrees counterclockwise around to the loading position (A). In
the
present embodiment both carriage 70 and rotary starwheel indexer 72 are
provided
with semi-circular wells conforming to the following standardized oral syringe
sizes:
0.5m1, lml, 3m1, 5m1, 10m1, 20m1, 35m1, 60m1. The need to manually index the
proper well of carriage 70 to that of starwheel indexer 72 prevents the in-
feed of a
wrong-sized syringe. The starwheel indexer 72 then indexes both the position
of the
syringe (moving it 90 degrees counterclockwise into the fill position), and
the
orientation of the syringe (for syringes with offset nozzles it indexes the
nozzle to the
same angular position when the syringe is in the fill position).
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[0113] As seen in FIG. 8, the syringe S is held captive in the starwheel
indexer 72 by
a series of internal spring-fingers 171. Each spring finger 171 is a short
strut pivotally
mounted in an alcove 174 between adjacent wells of starwheel indexer 72, with
a
roller wheel 175 (or bearing surface) at its distal end impinging into the
well, and
biased inward by a compression spring 172. The slight impingement of the
roller
wheel 175 into the well traps the syringe S therein, and the spring bias of
spring 172
keeps it trapped unless forcibly removed.
[0114] Approximately half way to the loading position a nozzle positioning
mechanism 176 grabs the syringe nozzle and (if the nozzle is offset from
center-axis)
rotates it to a fixed position so that all syringes arrive at the loading
position (A) with
their nozzles uniformly oriented. Once in the loading position (A) the syringe
is filled
as described below. When finished, the operator pulls out the carriage 70 and
this
indexes syringe S around to an unloading position (B). The operator optionally
caps
the syringe, and removes the filled/capped syringe.
[0115] Referring back to FIG. 7, once in the fill position the syringe is
engaged by a
series of arms, upper 110, middle 111 and lower 112, that grip and operate the
syringe
S in order to effectuate the filling process.
[0116] As seen in FIG. 9, each arm terminates in a pair of fork shaped fingers
120
that form a horizontally oriented "V" shaped opening to engage the syringe
barrel and
plunger cross sections regardless of the size of these elements. Each arm is
independently servo controlled and slideable in both an up-down direction and
a
horizontal forward-back direction to facilitate engagement with and operation
of the
syringe and plunger. The upper and middle arms 110, 111 grip above and below
the
syringe barrel flange, while the lower arm 112 grips the plunger flange. The
local
OSPS computer calculates the distance to move the lower arm 112 and plunger
flange
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to extract the appropriate dose of medicine based on the prescribed dose
volume V
and known radius or diameter of the syringe S size retrieved. The linear
travel
distance H equals V/ 0 r2, where the radius r is stored in the database. The
linear
travel distance H constitutes the distance that the lower arm 112 needs to
travel to pull
the correct amount of medicine into the syringe S. The local OSPS computer
then
controls the movement of fill arms 110, 111, 112 in accordance with the
calculated
distance H, and may also account for other variables such as medicine
viscosity,
volume of fill, etc. to optimize either the linear travel distance H or the
filling force
exerted or filling time taken along that distance. With reference to FIG. 10,
a
preferred embodiment of the present invention provides the upper, middle and
lower
arms 110, 111 and 112, respectively, in a single stacked configuration each
having a
horizontally fixed base member 121 riding on a pair of ball slides 122 on a
set of
guide rails 123 vertically oriented with the housing 895 (of FIG. 7). Vertical
movement of each base member 121 on the guide rails 123 is controlled by a
linear
servo 124 situated below and extending into the housing 895. Each arm 110,
111, 112
is also provided with a horizontal reaching element 127 slideably mounted
horizontally to each base member 121 so as to ride up or down the guide rails
123
with the base member 121 while being extendable or retractable in the
horizontal to
engage the syringe S. Horizontal extension and retraction of the reaching
members
127 is controlled by a horizontally oriented linear servo 125 fixedly mounted
to each
base member 121 and engaged to the proximate reaching element 127, each which
is
itself mounted via a horizontally oriented ball slide assembly 126 affixed to
the base
member 121. The forked fingers 120 are horizontally disposed at the distal
ends of the
reaching elements 127. In this way the horizontal and vertical motion of each
arm
110, 111, 112 is individually controllable in two dimensions.
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[0117] Referring back to FIG. 7, in addition to the upper, middle and lower
arms 110,
111, 112, a plunger lifting arm 128 extends upward from below to depress the
plunger
of the syringe S into the barrel as will be described. The plunger lifting arm
128 is
controlled by a linear servo and is vertically oriented. In certain
embodiments the
lower arm 112 may serve both the plunger pull-down (withdraw) and plunger lift
(depress) operations.
[0118] Prior to inserting the syringe into the syringe fill/cap station 5, the
operator
will have selected from the Storage facility 2 the appropriate, prepared
container 104
from which to dispense the proper medicine into the syringe S. After verifying
its
contents by reading the human readable label, the container is manually loaded
into
the syringe fill/cap station 5 at the manual product interface 81, as shown in
FIG. 7.
The interface comprises an offset yoke 82 that engages the adapter cap 210
between
the upper and lower flanges 214, suspending the container 104. The operator
signals
"ready" by pressing a button at the control interface.
[0119] Prior to filling, the scanner at the syringe fill/cap station 5 reads
the machine
readable label on the surface of the container 104 or cap 210 to again verify
that the
selected container contains the correct medicine.
[0120] Once verified to be the correct, a fill arm 105 comprising a pair of
grippers
143 are moved over the yoke 82 around the flanges capturing the container 104
in
position. The grippers 143 are slideable toward and away from each other and
are
provided with a series of grooves and ridges in their opposing faces to
cooperatively
engage with those of the container adapter cap 210 to facilitate secure
engagement
with and gripping of the cap.
[0121] Movement of fill arm 105/gripper arms 143 over the yoke 82 may be
accomplished by slideably mounting the fill arm 105 on an arm carriage 106,
and
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mounting the arm carriage 106 on a horizontal ball slide 140 and track 141 or
tracks
on or in the housing of the syringe fill/cap station 5 so as to be advance
able forward
and backward between a syringe S in the loading carriage 70 at one end of the
fill
station and the product interface 81 at the other end. A linear actuator 142,
preferably
pneumatic, is provided to slide the arm carriage 106 on its track(s) 141
between the
forward and back positions or to its home position between the two extremes.
The
arm carriage 106 is generally a vertically oriented plate member supporting a
fixedly
attached, pneumatically driven container rotator/inverter assembly 107. The
container
rotator assembly 107 controls rotation of a rotator arm 108 about a horizontal
axis.
Fixedly attached at a distal end of the rotator arm 108 is the fill arm 105
including
grippers 143 disposed to engage the adapter cap 210 of the container 104 when
the
container is situated in the product interface 81. The container
rotator/inverter
assembly 107 may include a conventional servo motor 109 with perpendicular
axis
attached at the lower end of the rotator arm 108. This way, after capturing
the
container 104, the servo 109 flips the container 180 degrees forward,
inverting it, and
moving it into a fill position and orientation for filling of the syringe S.
If the
medicine in container 104 must be shaken, the servo 109 first shakes the
container
back and forth before flipping it.
[0122] During fill operations the upper, middle and lower arms 110, 111 and
112 are
initially in a horizontally retracted state. When the syringe S is loaded, the
upper and
middle arms 110, 111 are extended so that the syringe is received within the V-
notch
and the fingers 120 are engaged to the surface of the barrel (upper arm) and
plunger
(middle arm) (see FIG. 7) such that the barrel flange is between the upper and
middle
arms. The upper and middle arms 110, 111 then slide vertically toward each
other to
tightly grip the barrel flange between them. The opposing surfaces of the
upper and
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middle arms 110, 111 may be provided with a resilient and/or high friction
surface to
securely engage the barrel flange. The lower arm 112 engages the plunger above
the
plunger flange in a similar manner while the lift arm 128 extends upward to
engage
the distal end of the plunger. The lower and lift arms 112, 128 are brought
together to
engage trap the plunger flange between them.
[0123] Simultaneously, the arm carriage 106 is drawn back under control of its
actuator 142 such that the gripper assembly 109 engages the adapter cap of the
medicine container in the product interface 81 securely gripping the cap and
engaging
the container 104 between fingers 143. The arm carriage is then advanced
forward to
withdraw the container 104 from the product interface 81. If needed, the
rotator arm
108 is actuated in a back-and-forth motion to agitate or shake-up the medicine
within
the container 104. Once mixed (if necessary) the rotator arm 108 is rotated
fully
forward to invert the container over the syringe S such the adapter cap is
aligned over
the tip of the syringe. The syringe is then lifted by coordinated movement of
the arms
110, 111, 112, 128 such that the nozzle is sealingly engaged within the
elastomeric
insert 225 of the adapter cap 210.
[0124] If the syringe S is entirely evacuated at this stage (i.e. the plunger
is fully
depressed within the barrel), the lower arm 112 is initially dropped,
withdrawing the
plunger from the barrel and drawing the medicine into the syringe. As noted,
in
certain embodiments the syringe may have a predetermined amount of air in the
barrel
to pre-pressurize the container 104. In such a situation the position of the
plunger (and
hence the volume of air in the barrel to be injected into the container) is
determined
by the system based on known parameters of the medicine, the container volume
and
its current fill level, and the plunger is positioned accordingly prior to
insertion into
the adapter cap by relative movement of the upper, middle, lower and lifting
arms
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110, 111, 112 and 128. Upon insertion of the tip in the adapter cap the
plunger is first
fully depressed by the lift arm 128 to pressurize the container and
subsequently
withdrawn by the lower arm 112 at a predetermined rate to fill the syringe S
with
desired amount of medicine without cavitation.
[0125] When the syringe is filled to the desired level, the arms 110, 111, 112
and 128
are lowered in unison and the syringe S is withdrawn from the adapter cap 210
and
the elastomeric insert 225 returns to it closed/sealed position. If desired,
the syringe
plunger may be further withdrawn from the barrel slightly by relative movement
of
the lower arm 112 as the nozzle I withdrawn to draw in any medicine left in
the
elastomeric insert 225 so as to avoid drippage.
[0126] With the syringe withdrawn, the rotator arm 108 (FIG. 7) rotates to
lift the
container 104 into an upright position and the lower and lift arms 112, 128
disengage
the plunger. The upper and middle arms 110, 111 return the syringe to the
loading
carriage 70, where the handle 74 can be withdrawn for retrieval by the
operator.
[0127] The (optional) automated capper 147 may place a cap on the open tip of
the
filled syringe, fed from an inclined capping chute 149. Where capping is not
automatic, the operator may manually place a cap over the tip prior to
weighing.
[0128] FIG. 11 is an enlarged perspective view of the automated capper 147 and
inclined capping chute 149. Automated capper 147 is a robotic capper under
control
of the Local OSPS computer with a servo-controlled positioning arm 153 and
pneumatic capping mechanism with a distal cap-gripping chuck 153. The
positioning
arm 153 is positioned over caps fed from chute 149 and picks and places them
on the
inverted syringes while held in arms 110-112 in the loading position (A) in
carriage
70.
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[0129] During batch operation a series of syringes S to be filled with the
same
medicine may be queued and loaded in sequence by the operator for filling.
When no
more syringes are to be filled with the particular medicine, the local
container 104 is
returned to the product interface 81 to be removed and returned under local
OSPS
Computer guidance to the medicine Storage facility 2 by the operator, who may
retrieve another medicine and replace it in the product interface 81 for the
next
medicine to be dispensed.
[0130] Referring back to FIG. 2, after retrieval from the loading carriage 70
the
operator places the syringe on inspection system 6 to cross check the weight
and/or
volume of the filled syringe against the expected weight/volume. The tare
weight
check is based on the known weight of the empty syringe and the volume of the
prescribed medicine. The vision inspection entails an optical inspection based
on the
location of the syringe S plunger, the volume above the plunger and below the
syringe
tip, and bubble check. If the inspection station 6 determines that the syringe
is filled to
the correct volume and/or weight with an acceptable amount of bubbles, it will
be
accepted. Otherwise it will be rejected.
[0131] The labeled, filled and capped syringe is then bagged at bagger 7 for
distribution to the patient, the bag itself being labeled in a similar manner
as to the
syringe. Bagger 7 may be any suitable commercially-available bagger with a
network-capable bag printer, bag storage/dispenser, and heat seal assembly. A
variety
of automatic "tabletop bagger/printers" are available for this purpose.
[0132] With reference to FIGs. 12 and 13, a control system architecture for
the
system 100 is disclosed in which a main controller 300 is provided in
communication
with a series of sub-controllers for one or more station steps via a
communications
backbone 310, in the depicted case, via Ethernet. The main controller 300 is
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preferably a microprocessor based microcontroller or PC containing a processor
core,
memory, and programmable input/output peripherals. The controller contains a
system safety controller, logic controller, top level motion controller and
human-
machine interface for interaction with a system operator. The main controller
300
further incorporates a database read/write module for interaction with a local
or
remote customer (patient) records database and local event database for
managing
downstream component operation. An order listener/parser module is provided
for
receiving orders from an external pharmacy/prescription entry and management
system maintained by the institution. The parser can be custom formatted to
discern
and populate order information based on a user specified data stream and
structure.
[0133] Sub-controllers are provided for all downstream machine sections such
as a
Syringe Auto-loader 320 (if robotic arms are used as per below), Filler/De-
capper/Capper/Rejecter 330, Checker/Verifier and Secondary Rejecter 340 and
Medicine Library 350. The sub-controllers are each provided with a safety
controller,
local input/output system and local motion controller integrated with the main
controller 300 via the communications backbone 310. The main controller
orchestrates the integration and operation of the downstream machine elements
as
described above and controls the overall operational mode of the system 100.
[0134] The local OSPS Computer may incorporate fill weight/volume adjustment
software. Specifically, the inspection station 6 is networked to the Local
OSPS
Computer and may provide weight or volume feedback to automatically adjust the
amount of liquid transferred into the oral syringe at servo-operated syringe
fill/cap
station 5. The software determines if a syringe has too much or too little
medicine in
it. Any out-of-spec syringe will be rejected and another one will be prepared
utilizing
feedback from the fill weight/volume adjustment software.
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[0135] FIG. 15, 16 and 17 show a perspective, top cross-section and end cross-
section, respectively, of an alternate embodiment of the syringe staging
mechanism
that eliminates the starwheel indexer 72. Instead the push-handle 74 pushes a
pocket
block 433 linearly back-and-forth to/from the loading position (A). The pocket
block
433 is a solid block formed with a plurality of yokes or pockets 435, each
pocket 435
sized to seat one of the following standardized oral syringe sizes: 0.5m1,
lml, 3m1,
5m1, 10m1, 20m1, 35m1, 60m1. The operator places a retrieved syringe S into
its
conforming pocket 435 and this likewise prevents the infeed of a wrong-sized
syringe.
The pocket block 433 then translates with handle 74 to index the position of
the
syringe (moving it linearly into the fill position A). A syringe tip locator
437
protrudes beneath each pocket 435 to ensure that syringes with eccentric
nozzles are
oriented with the off-center nozzle on generally on target. As seen in FIG.
16, a
nozzle positioning mechanism 476 is embedded inside the pocket block 433 to
exactly
index the orientation of the eccentric nozzles. Nozzle positioning mechanism
476
comprises a plurality of spring-loaded pins 479. When a particular syringe S
is
placed in its proper pocket 435 a pin 479 is extended out of the pocket block
433 to
act as a stop to ensure that pin 479 brings the syringe tip to the center of
the fill zone
A. If desired, a variety of interchangeable pocket blocks 433 may be provided,
each
with a subset of pocket 435 sizes, to collectively seat a wider array of
syringe sizes.
As with the starwheel indexer 72, pocket block 433 with spring-loaded pins 479
shuttles the syringe S and (if the nozzle is offset from center-axis) rotates
it to a fixed
position so that all syringes arrive at the loading position (A) with their
nozzles
uniformly oriented. Once in the loading position (A) the syringe is filled as
described
above. When finished, the operator pulls out the carriage 70 and this indexes
syringe
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S around to an unloading position (B) as seen in FIG. 16. The operator
optionally
caps the syringe, and removes the filled/capped syringe.
[0136] As yet another syringe infeed assembly alternative to the starwheel
indexer 72
of FIG. 8 or the pocket block 433 of FIGs. 15-17, FIG. 19(A-C) shows a
perspective,
top cross-section and end cross-section, respectively, of a syringe infeed
pick and
place mechanism that employs a carriage mounted grip arm apparatus 30 with a
vertically oriented strut 31 having upper and lower gripper arms 33 extending
laterally
to engage the syringe S such that the unit has a profile in the form of an
"F". The
gripper arms 33 are stationary, but an opposing finger 32 articulates toward
the
gripper arm 33 to grip the syringe S barrel. Each upper and lower gripper arm
33 is
provided at its distal end with a cradle to engage the outside surface of the
syringe
barrel. The upper and lower cradles are vertically aligned with one another
and may
be semicircular in form but are more preferably a "V"-shaped notch so as to
engage at
two pointes the outside surface of a tubular syringe barrel of the variety of
sizes
dispensed by the magazines of the syringe store. The inner surface of the "V"-
notch
may be provided with a high friction surface such as a rubber or other
elastomeric
surface to better grip the syringe. Alternately, the inner surface of the "V"
notch may
be provided with horizontally oriented high friction rollers to permit axial
rotation of
the syringe S within the cradle while preventing the syringe from slipping
down/out
of the cradle as described below. The cradles are oriented so as to be open in
the
forward direction of travel of the carriage. A pivot point is provided for
each finger
32 along its length prior to the "V" notch for rotatably mounting on a bushing
or
bearing. The finger 32 is generally rigid along its length but may have a high
friction
coating or surface as with the cradle to better grip the syringe barrel. A
lever arm 34
angularly offset from the longitudinal axis of the finger 32 is affixed to the
finger,
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preferably at the pivot point. A servo motor or high speed linear actuator is
connected
between the lever arm 34 and the vertical strut 31 such that operation of the
linear
actuator causes the finger to extend over the open face of the cradle and
trap/hold a
syringe positioned in the cradle between the high friction surfaces of the
cradle and
the finger 32. The linear actuator may be electric, pneumatic, hydraulic or
mechanically driven. In a preferred embodiment a separate actuator and finger
assembly 32 are provided for the upper and lower arms 33. In certain alternate
embodiments a single actuator may drive both an upper and lower finger 32. In
certain other embodiments a single finger 32 may be provided with upper and
lower
cradles, although in such an embodiment the syringe barrel must span the
distance
between the upper and lower cradles to engage them both simultaneously. In
certain
other embodiments the distance between the upper and lower arms 32 may be
variable. The grip arm apparatus 30 of this embodiment is slideably mounted to
a
carriage 40 under control of an actuator such that the grip arm apparatus 30
may be
advanced perpendicular to the direction of the travel of the carriage. After
capturing a
desired syringe the grip arm apparatus 30 is withdrawn to a home position such
that
the central longitudinal axis of the syringe barrel is positioned along a
centerline. The
above-described automated system in all its embodiments is capable of filling
and
packaging oral syringes in the hospital pharmacy primarily on a patient
specific, just-
in-time, medication error-free, and cost effective basis. The OSPS System 100
is
specifically designed to dispense from a library of up to 250-300 liquid
medication
into 0.5m1, lml, 3m1, 5m1, 10m1, 20m1, 35m1, and 60m1 size syringes (both
clear and
amber) based on the doctor's prescription on a semi-automated basis. Its semi-
automated throughput is approximately 3-5 syringes per minute based on 1-10m1
size
syringes, with inspection checks at each step in the process to ensure that
the syringe
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was packaged correctly. The Track, Trace and Validation Software documents the
entire packaging process and generates an audit trail available for recall in
the future.
It is important to understand that the preferred embodiment of the OSPS System
100
is designed for semi-Automatic operation in which a Pharmacy Technician will
select
and carry the syringes S and containers 104 to each packaging station, and
will return
the containers 104 back the Storage Facility 2 after all of the syringes have
been filled
with that medication. This (rather than a fully automated system) affords all
of the
customary visual checks and inspections normally conducted manually, but
speeds the
manual process significantly and imposes a much more rigorous automated
inspection/logging protocol atop the manual process to avoid all the typical
human
errors.
[0137] The system can be further automated by the use of robotic arms
networked to
the local OSPS Computer for conveying syringes S and medicine containers 104
from station-to-station in place of the operator. If this is desired then due
to the
extensive range required (approximately six feet) to traverse the distance of
the
current System 100, and the size of one robot, the inventors envision the use
of two
robots. A first robotic arm would be responsible for syringe selection, flag
labeling
and filling, while the second robotic arm would be responsible for inspection
and
bagging.
[0138] FIG. 14 illustrates another embodiment of the system 100 which includes
a
first robot arm 875 and a second robot arm 876 as indicated. The first robot
arm 875
places the prepared medicine container 104 with its adapter cap 210 mounted
and bar-
coded into the filling staging area. The first robot arm 875 then moves to
select the
proper syringe from syringe storage 3, and next holds the syringe S in place
for flag
labeling at labeler 4. Once labeled the barcode is identified through the
robot arm 875
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ability to hold the label in front of the scanner for detection and
identification as to
the parameters for filling, including medication type, fill volume, servo
plunger
movement speed, refrigeration etc. Possibly, robot arm 875 could retrieve a
container
from Storage facility 2, and if refrigerated hold the refrigerated container
next to a
temperature sensor to ensure it was properly refrigerated. Arm 875 would then
move
container 104 into the fill/cap station 5.
[0139] Once filled and capped the second robot arm 876 would take the syringe
and
place the filled, capped and labeled syringe into the check-weigh/vision
sensing
inspection station 6 for inspection of fill volume. Once completed and
accepted as
correct, second robot arm 876 would place the syringe into the bagging system
7 and
return to accept another filled, capped, labeled syringe.
[0140] The foregoing fulfills prescription orders in a just-in-time
environment, and
solves the problems inherent in the handling of all the myriad prescription
containers
containing the pharmaceuticals to be dispensed, as well as variously-sized
oral
syringes, bringing them together in a controlled environment to quickly and
accurately fill and label each syringe and to verify its work as it proceeds
in order to
avoid medication errors in the process.
[0141] In other cases, where a lesser degree of automation is required at
significantly
lowered costs, a simplified syringe filling and labeling system is offered.
This system
does not require the specialized adapter cap previously described. Rather,
this system
uses a Baxa AdaptaCapTM already in use by many hospital pharmacies. The system
does not require that a special barcode label with information on the
medication be
generated and attached to the cap or medicine container. Instead, the
manufacturer's
barcode on the container is utilized. Refer to FIG. 20 for a flow diagram of
the
syringe filling and labeling process. A track, trace and control system is
similar to the
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OSPS previously described is provided. The objective of the simplified syringe
filling and labeling system is to ensure that the proper medication is filled
into the
syringe and that the syringe is labeled correctly. If an optional weight check
or
volume check station is utilized, the proper amount of fill can be verified.
[0142] FIGs. 18A-C are a perspective stepwise composite view of a simplified
filling
system with manually-adjustable medicine container grippers. The simplified
embodiment is envisioned to be a bench top filling station. Rather than
indexed
medicine container and syringe in-feeds and servo-operated gripper fingers,
the
operator manually selects the appropriate medicine container 104 and syringe S
size.
In FIG. 18A, the medicine container 104 is manually positioned between at
least one
and preferably two pair of opposed self-centering gripper fingers 920, which
converge
to grip the container by the body and preferably also by the neck for
stability. The
spacing between the opposed gripper fingers 920 is manually adjustable by
control
knobs 930 for each pair, each control knob 930 operating by worm gear or other
suitable mechanism to close the respective pair of gripper fingers 920 about
the
container 104, thereby centering and anchoring it, or conversely to open them
for
release. An adjustable stop 952 provides positive positioning of the adapter
cap 904.
Similarly, the syringe S is manually positioned between at least one and
preferably
two pair of opposed self-centering gripper fingers 910, which converge to grip
the
syringe S by the body. The spacing between the opposed gripper fingers 910 is
manually adjustable by control knobs 940 for each pair, each control knob 940
likewise operating by worm gear or other suitable mechanism to close the
respective
pair of gripper fingers 910 about the syringe S, thereby centering and
anchoring it, or
conversely to open them for release. Since this embodiment does not grip the
adapter
cap 904, the adapter cap used in this embodiment need not be as comprehensive
as
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cap 225 shown in FIG. 5. Rather any manufacturer-supplied adapter cap may be
used
provided that it forms a leak-proof seal with the syringe S nozzle. Thus, any
conventional cap, such as Baxa's AdaptaCapTM bottle adapter cap may be used
(as
shown in U.S. Patent No. 4,493,348).
[0143] With additional reference to FIGs. 18, the simplified syringe filling
system
utilizes a 180-degree rotating platform 950. It consists of two sets of
manually
adjustable "V" type grippers. One set of grippers 910 for the syringe and one
set of
grippers 920 for the bottle. The medicine bottle 104, equipped with the Baxa
style cap
is placed up against the stop block 952 and adjustable "V" grippers 920 are
used to
hold it in place. Once the bottle 104 and Baxa cap are placed up against the
stop
block 952, which is used as a reference locator for all containers with Baxa
type caps,
the syringe S is manually pushed into the Baxa Cap and is gripped via the
upper set of
syringe grippers 910. Both sets of grippers are operated both inward and
outward with
the aid of adjustment knobs 930, 940 and slots. Once engaged in the baxa cap,
the
platform 950 is rotated clockwise until the syringe plunger comes in contact
with the
spring loaded "V"s. These "V"s are operated by either servo motors (e.g.,
servo motor
driven ball screw 951) or air cylinders. The later is for use with repeatable
dosing in
which the fill size is dictated by adjusting a stop for the air operated
system to limit
plunger travel. The former is operated in much the same fashion as the other
syringe
filling techniques previously described in the semi-automated descriptions
except it
consists of only a downward motion, thereby filling the syringe only. Syringe
removal
and releasing of the "V"s is performed manually.
[0144] FIG. 20 is a flow diagram illustrating the method of use of the
simplified
embodiment, with previously-described steps being like-numbered. In use, at
step
837 the operator manually selects the appropriate medicine container 104. The
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operator then scans the manufacturer barcode on medicine container 104 at the
filling
station to thereby confirm (via system database) that the correct medicine is
being
used. At step 839 the barcode on the syringe S is scanned to ensure
correctness. If
both are confirmed correct, then at step 840 the operator inserts medicine
container
104 and syringe S as shown in FIG. 19. The gripper arms 910 and 920 are
mounted
on a servo-driven rotating turret 950. When both container 104 and syringe S
are in
position as seen at inset (A), the syringe S is automatically advanced such
that its
nozzle penetrates the elastomeric seal 225 as seen at inset (B). As seen at
inset (C),
the turret 950 rotates to invert the two. During rotation, the syringe S
plunger moves
into engagement with a fork shaped finger 120 that form a horizontally
oriented "V"
shaped opening as described previously in regard to FIG. 9. Fork shaped finger
120
yokes the plunger, and the plunger is automatically withdrawn via a servo or
air
cylinder 960 for calibrated fill of syringe S with medicine from container 104
(FIG.
20 step 845). Once filled, the turret 950 is reversed, the knobs 930, 940
loosened, and
the syringe S and container 104 released.
[0145] The system minimizes downtime as well as processing time to take and
fill
orders, and is easy to clean and capable of maintaining an environment free
from
cross contamination. The system is open and accessible and allows interaction
and
oversight by a human operator at multiple points in the operation. Moreover,
it is
modular and permits a differing and upgradeable level of operator
participation (from
semi-automatic to and including full automation) based on the need of the
individual
institution.
[0146] It should now be apparent that the above-described system is driven by
prescription orders in a just-in-time environment, manages all the various
prescription
containers containing the pharmaceuticals to be dispensed, as well as
variously-sized
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oral syringes, to automatically converge them and orient, fill, label and cap
each
syringe and fully verify its work as it proceeds in order to avoid medication
errors in
the process. The pharmacy automation system for oral syringes substantially
improves the pharmacist and technician productivity and maintains an
environment
free from cross contamination.
[0147] Having now fully set forth the preferred embodiment 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 occur to those skilled in the art upon becoming familiar with
said
underlying concept. It is to be understood, therefore, that the invention may
be
practiced otherwise than as specifically set forth in the appended claims and
may be
used with a variety of materials and components. This application is therefore
intended to cover any variations, uses, or adaptations of the invention using
its general
principles. Further, this application is intended to cover such departures
from the
present disclosure as come within known or customary practice in the art to
which this
invention pertains.
INDUSTRIAL APPLICABILITY
[0148] Medical facilities are moving toward electronic prescription ("e-
prescription")
systems which use computer systems to create, modify, review, and/or transmit
medication prescriptions from the healthcare provider to the pharmacy. Any
syringe
fill automation system suitable for use in a hospital setting must interface
with an
existing e-prescription system (which records and transmits prescriptions to
the
pharmacy), and must be capable of filling prescription orders in a just-in-
time
environment. However, oral syringes are manufactured in a variety of sizes
with
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differing tip and plunger configurations. Moreover, oral medications are
commonly
provided in bulk form in variously sized bottles or containers having threaded
screw
caps that must be removed and replaced between uses. Given the diversity of
oral
syringes and medicines available, it is very difficult to implement a semi-
automated
(or fully-automated) oral syringe filling system with sufficient dexterity to
manipulate
all the myriad prescription bottles containing the pharmaceuticals to be
dispensed as
well as variously sized oral syringes, bringing them together in a controlled
environment to quickly and accurately fill and label each syringe and to
verify its
work as it proceeds in order to avoid errors in the process. There would be
significant
industrial application for a semi-automated system suitable for use in a
hospital
setting for filling patient-specific doses of liquid medications to be
administered by
oral syringes on a just-in-time basis, as well as an automated alternative.
Such a
system would enable hospital pharmacists to simplify and streamline their
task,
increasing the number of prescriptions that can be filled in a day, improving
patient
safety and care by minimizing medication errors and the consequences that
ensue.
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