Note: Descriptions are shown in the official language in which they were submitted.
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PCT APPLICATION FOR INTERNATIONAL PATENT
Invention: SYRINGE PACKAGING SYSTEM FOR HOSPITAL PHARMACIES
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SYRINGE PACKAGING SYSTEM FOR HOSPITAL PHARMACIES
[001] Continue to [002]
BACKGROUND OF THE INVENTION
1. Field of the invention
[002] 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
[003] 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
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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 Elf" Issue 39 (2008), According to the
Commission Report,
the most common types of harmful pediatric medication errors were improper
dosetquatitity
(37.5 percent) and unauthorized/wrong drug (1:3.7 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.
[0041 Oral syringes, which are relatively inexpensive and disposable, 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. 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
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, which is thus visible within the barrel, Oral
syringes are commonly
marked in units of milliliters and come in standard sizes ranging from 0.5 to
60 milliliters. 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. 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
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while others have the nozzle offset from the central axis. This variability
makes it difficult to
automate the filling process for oral syringes.
f0051 Pharmacies at in-patient medical thcilities and other medical
institutions fill a large
number of prescriptions on a daily basis including presciiptions 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 delivery by oral syringe is time consuming, labor
intensive and prone to
hunum error. To ensure that the medication is packaged error-free, the
pharniacy 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; 0) 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
(with or without
light protection) 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
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inserts the tip of an oral syringe into the container which has previously
been adapted to accept
the syringe, inverts the container, and then withdraws the plunger to draw the
medication into the
barrel of the syringe. After filling with a proper amount, the syringe and
medication container
are rotated back to the original position, the syringe is removed from the
container, the tip of the
syringe is covered with a cap for transport to the patient and the syringe is
labeled to indicate its
content and the intended recipient, and then bagged. Priori administering the
dose, the muse
can determine the amount of the dose by observing where the tip of the plunger
or piston is
located in the band.
10061 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 to indicate to the administering
nurse the content of
the syringe. However, the filling and capping of oral syringes 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 thus significant.
Automated systems have
been developed by Haut, Inc., For Health Technologies, Inc., intelligent
Hospital Systems and
others for the automated filling of injectable syringes.
1.0071 For example, U.S. Patents 6,991,002; 7,017,622; 7,631,475 and 6,976,349
are all drawn
to the automated removal of a tip cap from an empty syringe, the placement of
the tip cap at a
remote location, and the replacement of 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 a
hose to a fluid source. U.S. Patent. 7,610,115 and Application Publication
2010/0017031 show
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an Automated Pharmacy Admixture System (APAS). U.S.
Application Publication
2009/0067973 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 7õ68I,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 S,692,640 shows a system for establishing and maintaining
the identity of
medication in a vial using preprinted, press= sensitive, syringe labels.
10081 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 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 .prepaiation 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, the
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requirement of expensive disposable contact parts, and other features that add
unnecessary cost
and complexity to the process for filling and packaging oral syringes.
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 in the
filling and packaging of oral syringes. The present invention was developed to
fill this void.
10091 Oral syringes are manufactured in a variety of sizes with differing tip
and plunger
configurations, as described in part above. Moreover, oral medications are
commonly provided
and/or stored in bulk form in variously sized, manufacturer-supplied (OEM)
bottles or containers
having threaded screw caps that must be removed and replaced between uses.
tinder the prior
art, in order to fill an oral syringe from the manufacturer-supplied
container, the original
container cap must be replaced with a cap that allows insertion of an. oral
syringe nozzle.
BaxaTM sells an "Adapta-Cap"rm bottle adapter in a variety of sizes that
replaces the OEM caps
to convert a standard prescription or manufacturer bottle into a filling
device for oral syringes.
These Adapta-Capm bottle adapters are screw-on caps with open center-holes
capable of
accepting an oral syringe nozzle, and a tethered closure. This enables an oral
syringe to enter its
center hole and withdraw an amount of liqaid from the medication container
while the
medication container is positioned upside down. Unfortunately, the Adapta-
CapIm bottle
adapters have no internal valves and are not self-sealing. Thus, for the
syringe to be removal
from the medication container, both syringe and medication bottle must be up-
righted. Once up-
righted, the syringe can be removed from the up-righted medication bottle with
no leakage. If
the medication bottle requires shaking at any given time, it must be done
manually or in a
separate shaker while 'upright when using the prior art Adapta-Capm,
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10101 It is known that an adapter cap can include a selfµsealing valve for
this purpose. For
example, United States Patent 8,459312 to Mama et al. (Comar) issued June 11,
2013 shows an
adapter to be pressed into the neck of a bottle to receive a syringe for
accessing the bottle
contents by a syringe. The adapter has a normally closed valve located at that
distal end to
prevent the contents from leaking out of the bottle if the bottle is inverted.
A very similar
construct was shown in United States Patent Application 20.110130740 by Levy
(13axa)
published June 2, 2011 (now abandoned). US Patent 4,493,348 shows a method and
apparatus in
which oral syringes QM be filled using a screw-on adapter cap 12. for
connecting the bulk
medicine container 10 and a syringe 14 so that the liquid medication can be
transferred from the
bulk container 10 into the syringe barrel 20. The syringe is inserted into a
nozzle 88 of the
adapter cap .12 and displaces a detent valve 92 (see US Patent 4,493,348 FIG.
6) that allows
medicine to flow through the nozzle 88 into the syringe. When not in use the
nozzle 88 may be
closed off by a plug 50 attached to a tether 48. The adapter cap 12 is well-
suited for manual
filling of oral syringes but is not suitable for automated filling.
1.01 I Additionally, all of the foregoing adapters allow a tapered tip oral
syringe to enter a
center hole and withdraw an amount of liquid from the medication container
while the
medication container is positioned upside down, allow an oral syringe be
removed front the
container whik the container is inverted, without leaking, and allow the
medication container to
be shaken while it is.positioned upside down without leaking. However, none
can accommodate
an oat syringe with a Luer-lock tip. The Luer-lock tip syringe, includes a
circular hub about the
oral syringe nozzle that screws into in a threaded sleeve on the medicine
container cap (see FIG..
39). As a result of a worldwide International Standards Organization directive
1SO-80369,
certain syringe types will be required to employ Luer-lock fittings to reduce
the risk. of
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misconnections between tubes, IV's, enteral devices, etc. In order to
accommodate this change,
any syringe fill automation system or semi-automatic system suitable for use
in a hospital setting
should be able to interface syringes with a Later-lock. fitting to a medicine
container equipped
with an adapter cap that preferably allows insenion, filling and withdrawal in
any orientation
without leaking, and which preferably enables the medication container to be
shaken without
leaking. Thus, preferably, a system of filling oral syringes should interface
both Luer-lock. and
tapered tip oral. syringes with medicine containers equipped with the
appropriate adapter cap. A
self-sealing adapter cap may accomplish these goals.
0i 2.J Given the diversity of oral syringes and medicine containers available
(and in use), any
semi-automated (or fully-automated) system will need sufficient dexterity to
manipulate all the
myriad -presctiption bottles containing the pharmaceuticals to be dispensed as
well as variously
sized oral syringes with tapered and [tier-lock tips, 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 till 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.
[0131 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
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
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records and transmits prescriptions to the pharmacy), and must be capable of
filling prescription
orders in a just-in-time environment.
SUMMARY OF THE INVENTION
[0141 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. The system enables hospital pharmacists to
simplify and
streaniline their taSk, increasing the number of prescriptions that can be
filled in a day, and
improving patient safety and care by minimizing medication errors and the
consequences that
ensue.
[0151 The present invention also provides foutteen embodiments of a medication
container
adapter for oral syringe filling system. The preferred embodiment is a self-
sealing valve which
allows the container to remain in an inverted position for the entire time the
syringes are being
filled, In addition the container may be shaken without removal from the shake
station,
BRIEF DESCRIPTION OF THE DRAWINGS
I016] 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:
[0171 FIG, 1 is a. flow chart of the overall method of the invention.
[0181 FIG. 2 is a perspective view of the entire pharmacy automation system
100 according to
an embodiment of the invention.
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10191 FIG, 3 is a more detailed flowchart of the substeps of the batch
fUlfillment process 750 of
FIG. 1.
[0201 FIG. 4 is a more detailed block diagram of the medication container
orientation and log-
in process 720 of FIG. I.
[0211 FIG. 5 is a composite view of six of the embodiments of
container/syringe interfaces
according to the invention. The container/syringe interfaces include closures
and neck inserts
meant. to facilitate the connection of an oral syringe to a medication
container for the purpose of
drawing fluid out of the container.
10221 FiGs, 6A and 68 are perspective views of an exemplary, vision inspection
station 9.
[0231 FIG. 6C shows an alternative articulating design for the backlight panel
97.
10241 FIG. 6D shows another alternative articulating design for the backlight
panel 97.
10251 FIG, 7A is an enlarged perspective view of a semi-automated syringe till
station 5 for
filling the syringes S.
10261 FIG. 78 is a composite view of a self-centering spring loaded bottle
gripper assembly
82C used as an alternative to fixed yokes 82 of FIG, 7A.
10271 FIG. 7C [is an enlarged perspective view of fixed yoke 82A illustrating
bow it is used.
10281 FIG. IC Il is an enlarged perspective view of fixed yoke 828
illustrating how it is used.
[0291 FIG. 7C III is an enlarged perspective view of self-centering jaws 82C
illustrating how
they is used,
10301 FIG. 7C IV is an enlarged perspective view affixed yoke 821)
illustrating how it is used.
[031I FIG. 7D is a further enlarged perspective view of the loading carriage
70 of FIG. 7A.
1032.1 FIG. 8 is a composite view of the syringe gripping arms 1.10, 111. and
11.2 terminating in
a pair of fork shaped fingers 120 that form a horizontally oriented "V" shaped
opening.
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10331 FIG. 9 illustrates an embodiment of the syringe gripping arms I 1 1 and
its drive
mechanism.
10341 FIG. 10 is an enlarged perspective view of the semi-automated capping
station 8.
10351 Ms, 11 and 12 illustrate an exemplary control system architecture for
the system 100 of
FIGs. 2-10.
10361 FIG. 13 is a perspective view of an exemplary cappingidecapping station
93 resident at
the Medication Container Orientation and Log-In Station,
10371 FIG. 14 is a perspective view of the optional label photographing
station 98 resident at
the Medication Container Orientation and Log-In Station.
10381 FIG. I 5A is a perspective view of an embodiment of the syringe
size/color station 11A
which verities that the correct syringe has been !elected.
10391 FIG. 158 is a perspective view of an alternate embodiment of the syringe
size/color
station 1113 Which verities that the correct syringe has been selected.
10401 FIG. 16A illustrates an embodiment of a shaking mechanism 820 integral
to the filling
station 5.
10411 FIG. 168 is a composite operational diagram illustrating the operation
of the integral
shaking mechanism '820 of FIG. L.A.
10421 FIG. 17 is a perspective view of an alternative, remote medication
container shake station
6.
10431 FIG. 18 is a sequential illustration of the process for filling a
syringe S using a standard
commercially available "Baxa" cap 214;
10441 FIG. 19 is a sequential illustration of the process for tilling a
syringe S using an OEM-
Baxem Cap with self sealing valve 216.
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10451 FIG. 20 is a sequential illustration of the process for filling a
syringe S using a press in
bottle adapter (NBA) (no valve) 210;
[0461 FIG. .21 is a sequential illustration of the process for filling a
syringe S using a PIBA
(with valve) 212.
[0471 FIG. .22A is a process drawing depicting grouped stations with a
multiple sytinge
compartment tray (Option 3);
10481 FIG. .22B is a process drawing with one operator and three and grouped
stations (Option
2);
1049I FIG. 23 is a process drawing with three operators and three and three
grouped stations
(Option 3).
[050j FIG. 24 is a process drawing with two operators situated around a lazy
Susan (carousel.
like) disc 342.
[0511 FIG. 25 is a process drawing with three (3) operators situated around a
lazy Susan
(carousel-like) disc 342.
10521 FIG, 26 illustrates an embodiment of a syringe gripping module having
curvilinear distal
ends.
10531 FIG. 27 is a composite view (A, B and C) of a press in tip 223 for a
Baxarm or BaxaTm-
equivalent manufacturer-supplied medication container cap to interface with a
Luer lock oral
syringe.
(054f FIG. 28 is a composite view (A, B and C) of a press in tip 223 fer a
PIBA to interike
with a Leer lock oral syringe.
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10551 FIG, 29 is composite view (A, B and C) of a push-pull cap 224 for a
Baxam or Baxam-
equivalent manufacturer-supplied medication container cap to interfitce with a
Liter lock oral
syringe.
[0561 Ha 30 is composite view (A, B and C) of a push-pull cap 224 made
integral with a
Baxatm or Baxamequivalent manufacturer-supplied medication container cap to
interface with a
Liter lock oral syringe.
[0571 FIG. 31 is composite view (A, 13, C and I)) of a push-pull cap 224 for a
NBA cap to
interface with a Liter lock oral s7pTirtge.
1058] FIG. 32. is composite view (A, B and C) made integral with a push-pull
cap 224 for a
PIBA cap to interface with a Luer lock oral syringe.
10591 FIG. 33 is a composite view (A and B) of a self-sealing press in bottle
adapter (SSPIBA)
for use with a tapered tip syringe.
10601 Pia 34 is a composite. view (A and B) of a threaded cap modified with a
duckbill valve
having automation grooves for use with a tapered tip syringe.
[0611 FIG, 35 is FIG. 29 is composite view (A and B) of a BaxaTM or
Baxamequivalem
manufacturer-supplied medication container cap modified with a duckbill valve
to interface with
a. tapered tip oral syringe.
[0621 Fla 36A illustrates a tethered protective cap for push-pull cap 224 for
use in semi-
automatic operations.
[0631 FIG. 36B illustrates a separate protective cap for push-pull cap 224 for
use in fully
automated operations.
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10641 FIG, 37A illustrates a tethered protective cap for modified Baxam or
Baxitm-equivalent
manancturer-supplied medication container cap with duckbill valve for use in
semi-automatic
operations.
[065] FIG, 3713 illustrates a separate protective cap for modified Baxarm or
Baxaml-equivalent
manufacturer-supplied medication container cap with duckbill valve for use in
fully automated
operations.
10661 FIG. 38 is a side view of a tapered tip oral syringe.
[067] FIG. 39 is a side view of a Liter lock oral syringe.
1068] FIG. 40 is a perspective view of filling station 5 according to another
embodiment of the
present invention comprising a grooved block 400 for actuating push-pull
adapter cap 224.
[0691 FIG. 41 is an enlarged perspective view of the actuation, mechanism for
filling station 5
according to the embodiment shown in FIG. 40.
[0701 FIG. 42 is an enlarged perspective view of the actuation mechanism for
filling station 5
comprising a grooved block 400 for actuating push-pull adapter cap 224
according to another
embodiment oldie present invention
10711 FIG. 43 is a composite view (A and B) of the interaction between push-
pull cap 224,
grooved block 400 and yoke 82 according to the embodiments illustrated in
FIGs. 40-4.2.
[072] FIG, 44 is a composite view (A, B and C) of a valveless NBA 210 retrofit
to include an
integral valve .225 (typically, a duckbill valve) for use with a tapered tip
syringe.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
(073) 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
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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 skilled in the art may
utilize its teachings. It
will be understood that no limitation of the scope of the invention is thereby
intended. Ile
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.
[0741 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 bulk
medicine is typically
supplied in manufacturer-supplied medicine containers with conventional screw-
on caps. To
facilitate processing the present system also envisions the use of one or more
specialized adapter
caps for interfacing with tapered or bier lock type oral syringes;
alternatively, another type of
specialized cap may be provided to specification, or the OEM cap may be
replaced or retrofitted
with any available type of container/syringe interface to provide a penetrable
orifice. As
described more fully 'below, the retrofit may be accomplished in a number of
ways. One solution
is a press in bottle adapter (NBA), e.g., a press- in plug inserted into the
neck opening of a
medication container which enables an oral syringe to enter its center hole
and withdraw an
amount of liquid from the medication container while the medication container
is positioned up-
side-down. Another is a modified manufacturer-supplied capõAnother is an
adapter cap
specially designed to modify a manufacturer-supplied cap to interface with a
Luer lock oral.
syringe. Specifically, the present invention contemplates fourteen (14)
container/syringe
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interface variations: (1) a valve-less press in bottle adapter (PIBA) 210
(FIG. 5); (2) a self
sealing MBA (SSMBA) 212 with an integral valve (typically, either a linear or
a Z-shaped. slit)
213 (FIG. 5); (3) a standard .manufacturer-supplied (BaxaTM or Baxa
equivalent) valve-less
medicine container cap 214 with opening (FIG. 5); (4) a modified manufacturer-
supplied
(Baxarm or Baxa equivalent) medicine container cap 216 that is retrofit to
include an integral
valve 225 (typically, a duckbill valve) (FIG. 5); (5) a two-piece cap
comprising an outer portion
220 with a common outer diameter for all standard sizes of medication
container, and a self-
sealing insert 212 (FIG. 5); (6) a cap 221 comprising a common outer diameter
for all standard
sizes of medication container and having an integral self-sealing insert 212
(FIG. 5); (7) a
modified manufacturer-supplied (Baum, or Baxa equivalent) medicine container
cap 214 that is
retrofit to include a non-integral push-In tip .223 fbr interfacing with Luer
lock oral syringes
(FIG. 27); (8) a modified P1B.A 210 that is retrofit to include a non-integral
push-in tip 223 for
interfacing with Luer lock oral syringes (FIG, 28); (9) a modified
manufacturer-supplied
(Baum., or Baxa equivalent) medicine container cap 214 that is fitted with a
push-pull cap 224
for interfacing with Luer lock oral syringes (FIG, 29); (10) a modified
manufacturer-supplied
(Baxarm or .Baxa equivalent) medicine container cap 214 that is retrofit with
an integral push-
pull cap 224 for interfacing with Luer lock oral syringes (FIG. 30); (11) a
modified MBA 210
that is fitted with a push-pull cap 224 for interfacing with Luer lock oral
syringes (FIG. 31); (12)
a modified MBA 210 that is retrofit with an integral push-pull cap 224 for
interfacing with Luer
lock oral syringes (FIG. 32); (13) a cap 226 comprising a common inner
diameter for all standard
sizes of medication container, fined with an integral or separable valve 225
(typically, a duckbill
valve), and having grooved rings to facilitate handling, positioning, etc. by
the system according
to the present invention (FIG. 34); and/or (14) a valveless P1BA 21.0 that is
retrofit to include an
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integral valve 225 (typically, a duckbill valve) (FIG. 44). The that below'
summarizes the
fourteen (14) adapter cap variations according to the current invention:
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No. Description of adapter interface FIG. No. Reference No.
valve-less press in bottle adapter (NBA) 5 210
2 self sealing MBA (SSPIRA) with an integral valve 5 212/213
f tTically, either a linear or a Z-shaped slit)
.....
3 standard manufacturer-supplied (Baxa' m or Rasa 5 21.4
equivalent) valve-less medicine container cap with
opening
4 modified manufacturer-supplied (Baxatm or Baxa 5 216/225
equivalent) medicine container cap that is retrofit to
include an integral valve (typically, a duckbill valve)
two-piece cap comprising an outer portion with a 5 2201212
common outer diameter for all standard sizes of
medication container, and a self-scaling insert
6 cap comprising a common outer diameter for all 5 221/212.
standard sizes of medication container and having an
integral self-sealing insert
7 modified manufacturer-supplied (l3axaTM or Baxa 27 214/223
equivalent) medicine container cap that is retrofit to
include a non-integral push-in tip for interfacing with
Later lock oral syringes
8 modified P1B.A that is retrofit to include a non- 28 210/223
integral push-in tip for interfacing with Luer lock oral
syringes
9 modified manufacturer-supplied (Baxa n4 or Baxa 29 214/224
equivalent) medicine container cap that is fitted with
a push-pull cap for interfacing with Luer lock oral
syringes
modified manufacturer-supplied (13axam4 or Baxa 30 214/224
equivalent) medicine container cap that is retrofit
with an integral push-pull cap for interfacing with
Luer lock oral syringes
11 modified NBA that is fitted with a push-pull cap for 31 ¨ 210/224
interfacing with Liter lock oral syringes
.12 modified P13.A that is retrofit with an integral push- 12 210/224
pull cap for interfacing with Luer lock oral syringes
13 cap comprising a common inner diameter for all 34 225/226
standard sizes of medication container, fitted with an
integral or separable valve (typically, a duckbill
valve), and having grooved rings to facilitate
handling, positioning, etc. by the system according to
the present invention
14 valveless NBA that is retrofit to include an integral 44 2101225
valve (typically, a duckbill valve)
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10751 FIG. 5 is a composite view of the first six of the embodiments of the
container/syringe
interfaces according to the invention. The embodiments shown in FIG. 5 are
suited for use with
a tapered tip syringe S as shown in FIG. 38. The tapered syringe includes an
annular, tapered or
cylindrical nozzle through which liquid medication must pass to enter or exit
the body of the
syringe. The nozzle contains an open central channel.
10761 As shown in FIG. 5, two valveless embodiments include the NBA 210 and
OEMIBaxa
Cap 214 at left, and four valved embodiments include the valved PIBA 212, the
valved self-
sealing PIBA 212 integrally formed into, or combinable with, the common
diameter outer
portion 220 or 221) and a modified/sells-sealing OEM/Ba.xa Cap 216, All may be
adapted to fit a
variety of medicine bottle types and sizes.
10771 The valved NBA. 212, OEM/Baxa Cap 216 and common outer diameter caps
220, 221 all
include a self-sealing valve that closes when the syringe nozzle is removed to
prevent leakage
when the medication container is in the inverted position at thefill station.
10781 Both PIBAs .210, 21.2 comprise a press-fitted open plug inserted into
the neck opening of
a medication container. This enables an oral syringe to enter its center hole
and withdraw an
amount of liquid from the medication container while the container is
positioned up-side-down.
This syringe fining procedure must be repeated. for each syringe to be Med. If
the medication
container with open NBA 210 requires shaking this must be done manually with
the original
screw cap replaced over the neck. The above procedure must be repeated every
time shaking is
required regardless of whether the same medication is being filled into
multiple syringes. Also,
the original cap must be placed over the Medication bottle and its press-in
insert, during storage,
to ensure Cleanliness.
[0791 OEM/Baxa Caps 214 (see FIG. 5) are the commercially available "Bala"
screw on
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adapter caps which are applied to the necks of medication bottles to enable
them to fill oral
syringes. The standard commercially available "Saxe" cap consists of a female
threaded cap to
fa over medication bottles and is available in sizes to accommodate most
medication containers.
It enables an oral syringe to enter its center hole and withdraw an amount of
liquid from the
medication container while the medication container is positioned upside down.
For the syringe
to be removed from the medication container, both syringe and medication
bottle must be up-
righted. Once up-righted, the syringe can be removed from the up-righted
medication bottle with
no leakage. If the medication bottle requires shaking at any given time, it
can be done manually
or in a separate shaker by closing the tethered cap and fastening the bottle
into the shaking
mechanism (see FIG. 17 below).
[080i The valved OEM113ax.a Cap .216 (see FIG. 5) is preferably
modified/constructed with an
elastomeric check. valve member 225 held captive in the plastic cap body 2.19.
Examples of self-
sealing valves include check valves and simple diaphragms with a linear or a Z-
shaped
Again, it is important to remember that valved interfaces 212, 216 can be left
inverted at the
filling station 5 (FIG, 2 1.115) and even shaken without leaking, whereas
valveless interfaces 21.0,
214 (see FIG. 5) do not prevent leakage. Thus, valveless interfaces 210, 214
compel removal of
the syringe/container combination from the filling station 5 after each
filling operation.
10811 The elastomeric seal 225 (see FIG. 5) of the valved OEMIBaxa Cap 216 is
fitted within
an aperture in the flange of cap 219, 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 (see
FIG. 19) and/or filling of
the syringe (by vacuum) as described below. On withdrawal of the syringe tip
the resilient
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elastomeric seal 225 returns to its original shape closing the hole and
preventing leakage of the
fluid contents of the bottle 104.
[0821 FIG. 5 also shows cross-sections of alternative container/syringe
interfaces 210, 212
which comprise a PIRA fitted as a plug-in insert into the neck of the medicine
container. The
PIBA is an annular body sized to conform to the inside of the medicine
container neck and
adapted liar a friction fit therein, and may be formed with ribs as described
above for this
purpose. The interface 212 defines a central conduit, and the elastomeric seal
213 is fitted within
interface 212 across this conduit to serve as a penetrable seal as described
above.
1083j As still another option, any conventional cap, such as Baxa's
AdaptaCaprm bottle adapter
cap may be used (as shown in U.S. Patent No. 4,493,348 referenced above) and
simply modified
or equipped by the manufacturer or aftermarket with a penetrable elastomeric
seal such as Check.
valve 225, or other suitable self-sealing valve. In yet another embodiment of
the present
invention, a container/syringe interface includes an outer portion 220, 221
that will have the
same outer circumference for use on any of the standard sizes of medication
containers. It can be
used with a purchased, self-sea:1in insert, such as valved PIBA 212, or the
insert can be
integrally tbrmed within the outer portion 221. The interface between the
medication container
and the self-sealing insert will hold the outer portion 220, 221 securely onto
the top of the
medication container, locating the outer part on center with the opening of
the medication
container. The cap with outer petition 220, 221. may also include a tethered
protective cap (to
protect the contents of the medication container from contamination, such as,
for example, from
dust or other airborne particles) similar to the Baxa type cap, as shown in
FIG. 5. In one
preferred embodiment, the 2D bar code, described in further detail below, is
affixed to the top of
the tethered cap, The common outer diameter of outer portion 220, 221 for all
standard sizes of
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medication container caps can serve as a common means of locating the
medication container on
center with the yoke at the fill station. The common size of the flange 222 of
the outer portion
220, .221 of the instant tap embodiment may also facilitate transportation of
the medication
containers when used with a carousel designed to hold a single diameter
syringe/container
interface.
10841 FIG. 44 shows a composite view of another valved embodiment of the
container/syringe
interface for use with a tapered tip syringe: valveless PIRA 210 with integral
or non-integral
duckbill valve 225. This embodiment also may be adapted to fit a variety of
medicine bottle
types and sizes. The valveless MBA 210 with duckbill valve 225 comprises a
press-fitted open
plug inserted into the neck opening of a medication container. An elastomeric
check valve
member 225 is then inserted into the center hole of PIBA 210. Examples of self-
sealing valves
include check valves and simple diaphragms with a linear or a 2-shaped slit.
The hole. in the seal
225 expands as the tip of a syringe S is inserted to permit pressurization of
the container 104 (see
FIG. 19) 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. The presently
described valved
interface 210/225 can be left inverted at the filling station 5 (FIG. 2 III 5)
and even shaken
without. leaking. However, the original cap mast be placed over the Medication
bottle and its
press-in insert, during storage, to ensure cleanliness.
10851 Additional preferred embodiments are Illustrated with reference to FlGs.
27-37 and 39.
FIG. 39 depicts a Small Bore Luer Lod: (also referred to herein as a "Luer-
lock" syringe)
syringe which has an inletioutlet opening flush with the top edge of the
syringe body and
bordered by an annular flange which creates a female connection point for a
male nozzle to fill
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the syringe body with liquid medication through the inlet/outlet point. FIG.
27 is a composite
view (A, 13 & C) of a modified manufacturer-supplied (Baxim or Baxa
equivalent) medicine
container cap 214 that. is retrofit to include a non-integral push-in tip 223
for interfacing with
Liter lock oral syringes, shown in cross-section. Push-in tip 223 is
preferably composed of an
annular body having a tapered distal flange 223A, flange 223A having a
diameter that decreases
towards the distal end of tip 223 for insertion into the nozzle of the
manufacturer-supphed
medication container cap 214. Tip .223 further comprises an annular flange
223B (having a
diameter slightly law than the diameter of the nozzle opening for cap 214) at
its midpoint to
prevent tip 223 from sliding all the way into cap 214. The end of tip 223
opposite tapered flange
223A is sized to fit snugly within the outer flange of Luer Lock Syringe S. as
shown in FIG.
27C. This design requires the medication bottle to be upright while the
syringe is inserted into
the medication bottle nozzle. Then, both medication bottle and attached
syringe are inverted as a
unit and placed into the filler, as will be described. When syringe S is
filled, both medication
bottle and syringe are uprighted and the filled syringe is removed from the
medication bottle.
Tip 223 may use a separate cap 223C to prevent spillage of the contents of the
medication bottle
when syringe S is not attached to tip 223.
1086i FIG.. 28 is a composite view (A, B & C) of a modified NBA 210 that is
retrofit to include
a non-integral push-in tip 223 for interfacing with Luer lock oral syringes.
As in FIG. 27, tip 223
comprises a tapered distal flange 223A, flange .223A. having a diameter that
decreases towards
the distal end of tip 223 for insertion into the nozzle of the NBA cap 210,
while-the opposite end
of tip 223 is sized to fit snugly within the outer flange of Luer Lock Syringe
S. as shown in FIG.
28C. Tip 223 may use a separate cap 223C to prevent spillage of the contents
of the medication
bottle when syringe S is not attached to tip 223.
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1081 FIG, 29 is a composite view (A, B & C) of a modified manufacturer-
supplied (BaxaTM or
Baxa equivalent) medicine container cap 214 that is fitted with a push-pull
cap 224 for
interfacing with later lock oral syringes. Cap 224 comprises two separately
formed nozzle
sections that are slidably connected in a male-female link. A stationary
portion 224A for
attachment to a medication bottle comprises an annular body with a central
passage 80
therethrough, the central passage 80 being defined by an inner wall having a
specific progression
of diametric variations. A.t one end of the body of stationary portion 224A,
where stationary
portion 224A attaches to the top of a manufacturer-supplied (Baxaml or Baxa
equivalent)
medicine container cap 214, central passage 80 has a relatively large diameter
sized to conform
to and receive the conventional Baxarm oral medication cap with syringe
aperture 214 as shown
in FIG. 5.. It will be understood by one of ordinary skill in the art,
however, that stationary
portion 224A may be. sized to fit a Baxamequivalent manufacturer-supplied cap
based on
design preference. Central passage SO continues through stationary portion
22.4A at a diameter
sized to accommodate the upper, smaller-diameter nozzle portion of the
conventional Baxan4
oral medication cap 214, wherein the two diameters of central passage 80
connect to define a
shoulder 83 for press-fit anchoring of the conventional Baum (or Baxam-
equivalent) oral
medication cap 214. At a midpoint of the smaller diameter pOrtion of central
passage 80, a
tapered elastomer poppet 84, as will be described further herein, is anchored.
The outer wall of
stationary portion 224A may further comprise annular grooves for alignment
with the yoke of the
filling station, as further described herein.
[0881 At the distal end of stationary portion 224A opposite its attachment
with the
manufacturer-supplied medication container cap 214, stationary portion 224A is
slidably
attached to a second, sliding portion 22413 of push-pull cap 224, Sliding
portion 2.2413 also
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comprises a generally annular body with a central passage 85 therethrough, the
central passage
85 being defined by an inner wall having a specific progression of diametric
variations. At a. first
end, proximate the connection point between stationary 224A and sliding .224B
portions of cap
224, channel 85 has a diameter sized to fit securely around the outer diameter
of the distal end of
stationary portion 224.A. Channel 85 continues through sliding portion 224B to
a shoulder 89 at
the base of cap receiving chamber 60. Past shoulder 89, channel 85
progressively narrows in
diameter, terminating in a nozzle 90 at the distal end of sliding portion
.22413. Nozzle 90 is sized
to fit securely around the tip of poppet 84 when cap 224 is closed to provide
a secure, water tight
fit between nozzle 90 and poppet 84. This configuration prevents any fluid
medications from
leaking from the medication bottle when inverted upon removal of the syringe
from nozzle 90,
[089i Cap 224 comprises a tab and groove locking mechanism to ensure positive
locking
between stationary 224A and sliding 2.2413 portions of cap 224 in both open
(FIG. 29 at A) and
closed (FIG. 29 at B) positions. The locking mechanism comprises an annular
tab 86 extending
from the inner wall of channel 85 and flush with the distal end of sliding
portion 22413. Tab $6
corresponds in height and -width to two grooves 87a, 87b in the outer wall of
stationary portion
224A. When cap 224 is open, as shown in FIG.. 29 (at A), tab 86 fits securely
into groove Sib,
which is located proximate the distal end of stationary portion 224A, creating
a chamber 60
within channel 85to allow liquid medication to flow from manufacturer-supplied
medication
container cap 214 through channel 80 and around poppet 84 into channel 85 and
out through
nozzle 90 into the oral syringe during filling. Poppet 84 is anchored within
stationary portion
224A using one or more anchor points (see FIG. 29 at C, showing cross-section
A-A through
stationary portion 224A) that allow liquid to flow past poppet 84 as indicated
by the dotted line
in FIG, 29 (at A). Grooves 87a, *lib are spaced such that, when sliding
portion 22413 is pushed
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towards stationary portion 224A, tab 86 settles in groove 87a when the tip of
poppet 84 is flush
with the distal end of sliding portion 2248 forming a water tight seal with
nozzle 90. The
exterior wall of sliding portion 2248 comprises an annular slide disc 91 to
allow force to be
applied along the main axis of sliding portion 2248 to open and close cap 224.
At the distal end
of sliding portion 2248 proximate its connection with syringe 5, the outer
diameter of sliding
portion 2248 is sized to fit inside the female nozzle of a Later lock oral
syringe,
10901 This design enables opening and closing the flow of medication to the
Eater lock oral
syringe while the medication container is inverted. As such, the time to load
and unload, or
upright and invert, the medication container between syringe fillings is
eliminated. In addition,
the medication container can also be shaken in an inverted position betbre,
during or after a
syringe filling operation, when the medication so requires, as will be
described. The design also
allows for placement of the medication container bearing cap 224 into the
Syringe Filler (to be
described) via a yoke in an automated or semi-antornated process, and for
slide disc 91, which
controls the opening and closing of cap 224, to be automated for use in a
fully or semi-automated
process. Push-pull cap may further comprise a 21) barcode, as further describe
herein, on a
bottom edge of the slide disc 91 (facing up when medication container is
inverted tbr filling
operations) or elsewhere on cap 224 to enable easy tracking Of the medication
container bearing
that cap. Alternately, the 21) barcode described herein may be placed on the
base of the
medication container,
10911 FIG. 30 illustrates the push and pull-cap 224 of FIG. 29 wherein the
distal end of
stationary portion 224A is made integral with medication container cap 214 by
co-molding or
like means known :in the art. In this embodiment, the threaded portion of cap
214 may be
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provided in several standard sizes, such as 20mm, 24mm, 28mm, 33mm, etc.., or
in sizes which
are chosen as a matter of design or operator preference.
[0921 FIGs, 31 and 32 illustrate push-pull cap 224 which is made separate and
integral,
respectively, with a valveless PIBA cap. Instead of channel 80, at its end
proximate the
medication bottle, being sized to fit over a Baxatm or Baxem-equivalent
manufitcturer-supplied
medication container cap, it is instead sized to fit within outer wall of
stationary portion 224A,
which in turn is sized to fit within the open channel of a NBA cap as shown.
In FIG, 32, outer
wall of stationary portion 224A is made integral with the inner channel of a
MBA cap, and/or is
fitted with annular elastomeric rings to provide a press fit within the
opening. of a medication
container.
1093I :Ms, 34 depicts a cap 226 comprising nozzle fitted with an integral or
separable valve
22$ (typically, a duckbill valve, as shown in FIG. 34). The threaded inner
wall of cap 2.26 may
be provided in several standard sizes, such as 20mm, 2.4mm, 28mm, 33mm, etc.,
or in sizes
which are Chosen as a matter of design or operator preference. The outer wail
of cap 226
comprises two annular rings defining a groove to accept the fingers of the
automated or semi-
automated arms of the .filling station, as will be described. Grooves provided
on the outside of
the medication container cap not only fit into the yoke of the syringe filling
apparatus and hold
the medication bottle securely, but. also locate the medication container on a
reference center
line. Grooves may also serve as a means to handle, move and position the
medication. container
during selection from a medication container library as will be described.
[0941 FIGs. 36.37 depict protective caps for the medication container caps
described. herein.
Each protective cap is designed to fit securely over and cover the nozzle of
each of the
medication container caps described herein such that. the medication container
may be inverted
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without the attached protective cap falling off: For automated or semi-
automated systems, as
described herein, a separable cap can be used (see F1Gs. 3613 and 3711). For
semi-automated
systems only, a tethered protective cap may be used (see FIGs. 36A and 37A).
[0951 Each adapter cap may be barcoded with a unique identifier number. Where
a tethered
protective cap is used, the barcode may appear on the protective cap instead
of or in addition to
on the adapter cap itself. In addition, molded surface features or textures
may be provided on the
outer surface of each cap to provide a gripping surface.
[0961 In addition, one skilled in the art should understand that the
afiermarket valveless cap
(e.g., Baxa Adapta-cap' bottle adapter) and the adapter 2 as described above
and in other
embodiments of the present invention may essentially be combined in a single
unitary structure.
Specifically, the press-on container cap 214 may, if desired, be co-molded
with the valve adapter
cap 2 to form a unitary adapter cap. In addition, the valve adapter cap 2 may
include one or two
flanges to enable the container to be mechanically-handled for storage or
transport in a fully-
automated filling system such as shown and described in Applicant's co-pending
U.S. patent
application 13/ 236,577 filed 19 September 2011.
[0971 A preferred embodiment of the invention is now described with reference
to the NBA
with valve interface 212 of FIG. S. Process and system configuration
variations specific to each
of the container/syringe interfaces are also described below.
[0981 The support fixture illustrated in FIG. 7A. comprises a fixed-position
container holding
yoke 82 that engages the container/syringe interface 210, 212, 214, 216 (see
FIG. 5) suspending
the assembly. Note that the fourteen syringe.filling closure variations
container/syringe
interfaces 210, 212, 214, 216, .220, 221, 226, and the Baxem-type or P1BA
variations for caps
223 and 224, both integral and separable, suitable for use with the present
system necessitate
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differently sized/shaped container holding yokes 8.2, and for this reason yoke
82 may be
removably-mounted to filling station 5 by thumb-screws or the like, allowing
replacement with
different sizes and Shapes. For example, F1 G. 7C I shows a container holding
yoke 82A with
aperture configured to seat the protruding stem of an interfice 214, 216,
while FIG. 7C it shows
a container holding yoke 8213 with aperture sized to seat the neck of a
container in which an
intettice 210, 212 has been inserted. The platfomi thickness of yoke 82 is
also important as
valved versus valveless closures may require differing degrees of syringe
nozzle insertion and so
some yokes 82 may need to be very thin. The operator can choose the
appropriately-configured
yoke 82, and in all such cases the yoke 82 facilitates easy frontal insertion
of the
containerisyringe combination and stably supports the container.
1099J FIG. 711 is a composite view of a self-centering spring loaded bottle
gripper assembly
82C used as an alternative to fixed yokes 82 of FIG. 7A. The self-centering
spring loaded bottle
gripper assembly 82C. of FIG. 711 employs a pair of spring-loaded jaws 1002
slidably mounted
on a ball-slide track 1003 for slidable separation. A pair of trammel aims
1004 are coupled from
each jaw 1002 to a common pivot and thereby maintain symmetry of the jaws 1002
as they
separate. The operator rests the container neck onto the lips of jaws 1002 and
pushes the
container straight back, separating the spring-It:sided jaws, until the jaws
spring tight about the
container and it is gripped. Note that the jaws 1002 are formed to hook around
the container and
have a lowermost. flange to serve as a reference to ensure that all syringes
are uniformly located
in the vertical dimension. Thus, gripping assembly 82C is advantageously
better able to
withstand the shaking cycle and can fit into the limited space available.
1011001 The following table maps the container/syringe interface variations to
requisite variations
in the filling station 5 (Fla 2 III 5) and points out the advantages of
utilizing the self-sealing
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valve in the Baxa cap or PIBA for tapered tip syringes (as shown in FIG. 38)
and/or the push-
pull adapter cap 224 for Luer lock oral syringes (as shown in FIG. 39)
according to one or more
embodiments of the present invention:
No. Container/Syringe filling station Need to invert Able to Able to
fill
interface 5 container container and ' shake at fill multiple
syringes
neck syringe I 80* station? at one time
positioning and then rotate without removing
device I 80 after container from fill
tilling syringe? _____________________________________ station?
valve-less press in Yoke 8Th Ys No No
bottle adapter (FIG. 7C II)
(NBA) i 2 self sealing P Yes IBA Yoke
82B No Yes
(SSPIBA) with an (FIG. 7C T.)
integral valve or self-
centering jaws
82C (FIG. 7C
4 .. 3 valveless BaxaTM Yoke 82A Yes No No
or Baxa (FIG. 7C I)
4 valved liaxem or Yoke 8.2A No ...... t ye6 .. Yes
Baxa equivalent (FIG. 7C I) or
self-centering
jaws 82C
(FIG. 7C 1:11) _
Valved self- Yoke 8213 No Yes Yes
sealing two-piece (FIG. 7C IV)
220 or self-
centering jaws '
82C (FIG. 7C
III)
_______________________________________________________________________ =
6 Valved self- Yoke 821) No Yes Yes
sealing one-piece (FIG. IC IV)
221 or self-
centering jaws
82.0 (FIG, 7C
111) .......................................
7 Baxarm or Baxa Yoke 82A Yes No No
equivalent (FIG. 7C I)
modified with
non-integral
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push-in tip for
Luer lock oral
syringes
8 NBA modified Yoke 8213 Yes No No
with non-integral (FIG. 7C H)
push-in tip for
Liter lock oral
Baum or .B=1 Yoke 82A No Yes Yes
equivalent with grooved
modified with block 400
non-integral (FIG, 41)
push-pull cap
Baxarm or Baxa Yoke 82A No Yes Yes
equivalent with with grooved
integral push-pull block 400
, cap , (FIG. 41)
11 NBA modified Yoke 82B No Yes Yes
with non-integral with grooved
push-pull cap block 400
(FIG. 41)
12 RIBA with Yoke 82B No Yes Yes
integral push-pull with grooved
cap block 400
(FIG. 41)
13 Valved common Not shown) No Yes Yes
inner diameter
cap with grooved
rings
14 NBA retrofit with Yoke 8213 , No Yes Y
integral valve (FIG. 7C II)
or self-
centering jaws
82C (FIG. 7C
_______________________________________________________________________ ......
101011 With reference to FIGs. 7A and 7D, upper, middle, and lower syringe
gripping aims 110,
I I I and 11 2 are staged in a vertical orientation that will allow the
selected syringe S to be easily
slid into the fill zone, with plunger lifting wit 128 fully retracted. As
different syringe sizes
have different exterior dimensions, the vertical orientation of syringe
gripping arms 110, 111 and
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112 may be adjusted prior to syringe insertion to ensure that the syringe body
can easily fit
between the medication container and middle arm I 11, which, as will be
described, rests below
the hilt or flange of the syringe. The syringe S is connected to the
medication container and both
are held by yoke 82. Once the medicine container and syringe S are in place,
and the start button
is pressed, a guard is dosed around the filling station, or by some other
signal from the
processor, a pair of syringe finger grippers 78 dose about the syringe S and
hold it securely.
Syringe finger grippers 78 are air operated for opening and closing, or may
optionally be servo-
driven, and have a servo-operated mount which moves the fingers to the center
of the body (tithe
syringe. This feature advantageously ensures that the syringe tip is exactly
on center with the
yoke, as syringe tip to body eccentricity varies on syringes sized from
lOrni., to 60m1,. For
syringe sizes between 1.0m1., and fiOtnI, the tip of the syringe is eccentric
to the body diameter,
whereas on syringe sizes from 0.5mI., to Stiaõ the tip is concentric on. the
body diameter. The in
and out motion of the servo mown locates the grippers 78 to grip the center of
the syringe body
so that the center of the tip is always on center with the yoke, regardless of
its eccentricity to the
body of the syringe. Additionally, a bottle holder platform 79 lowers to
sandwich the medicine
container against the container holding yoke 82. The bottle holder platform 79
has an aperture
791 through it and a scanner 121 is mounted above the aperture 791 to read the
machine readable
label on the bottom of the container 104.
10.1021 An articulating syringe locator guide 81 (FIG 7.A) comprises a pair of
offset fingers on a
bracket that push against syringe finger flanges, effectively rotating the
syringe to a known
orientation. This ensures that all offset-tip syringes (nozzle offset from
center axis) are in proper
orientation for filling. One skilled in the art should understand that the
syringe locator collar 81
is not required for concentric tipped syringes and may be articulated out of
the way,
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10103] Once in the fill position in loading station 70 with syringe finger
grippers 78 closed
around it, the syringe S is engaged by the upper 110, middle I 1 1 and lower
112 arms, and a
plunger lifting arm 128 that extends upward from below, all of which
collectively grip and
operate the syringe S in order to effectuate the filling process as described
below.
(01.04f The syringe locator guide 81 withdraws to its home position. Upper arm
110 lowers and
middle arm 1 1 1 raises to close on the syringe body hilt or flange (see FIG.
19 for detailed view).
This creates a sandwiching effect to hold the body of syringe S securely.
Lower arm 112 then
moves downward onto the upper side of the syringe plunger disc and plunger
lifting arm 128
rises to a position just under the syringe plunger, thus working in concert
with lower arm 112 to
create a sandwiching effect on the syringe plunger disc captured between them.
Upon command
from the operator or programmer, arm 112 and arm 128 work in concert to
perform priming
and/or filling of the syringe S. The use of both arm 112 and arm 128 allow the
filling station to
exert both a pushing and a pulling effect on the syringe plunger as the
program dictates, thus
allowing better control of the plunger location during both priming and
filling. Upper and
middle arms 110 and 11 I may also work in concert to push syringe S further
upward towards the
medication container as necessary to ensure that the closure of the medication
container hasn't
relaxed its fit with the tip of syringe S. The priming sequence is determined
by syringe size and
viscosity of medicine to be filled. After priming is complete and with the
piston all the way up,
the piston is then pulled downward to fill with the correct dose.
101051 As described in more detail below, in a preferred embodiment, arms 110,
111, 112 (FIG,
26) protrude vertically from the horizontal base of the filling station 5
(FIG. 2), at which point
they are sealed with waterproof bushings, and terminate with at least one
horizontally-oriented
curvilinear jaw. The watertight seal between the vertically oriented syringe
filling arms 110,
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111, 112 and the horizontal base of the filling station 5 advantageously
prevents liquids (such as
medication from medication container 4) from being able to inter the interior
of filling station 5.
This curvilinear embodiment is thus preferred over the herein described
horizontal aims having
straight fingers wherein the horizontal arms 110, 111 and 112 must articulate
vettically through
one or more open vertical slots in the vertical back of filling station 5 (see
FIG, 7A), The
watertight seal and vertical orientation of curvilinear arms 110, ill, 112 is
accomplished via the
horizontally-oriented curvilinear jaw, which is able to grip various portions
of the syringe S
through a rotational motion of syringe gripping arms 11.0, 111, 112 and
withdraw the plunger of
the syringe S with vertical motion of syringe gripping arms 110, 111, 112.
[01061 As stated in the foregoing Table the yoke 82 will vary depending on the
syringe interface
variation. Specifically, the OFIWBaxa cap 214 will require yoke 82A (FIG. 7C
1), the
OEM/Baxa cap with self-sealing valve 216 will require Yoke 82A (FIG, 7C 1),
the valveless
NBA 210 will require yoke 828 (FIG. 7C 1.1), the NBA with self sealing valve
212 will require
the adjustable clamping device 82C (M 7C the
Luer-type syringe adapter tip .223 will
require the adjustable clamping device 82C (FIG, 7C III) or yoke 82A (FIG. 7C
I), push-pull cap
224 and the threaded cap with automation grooves and valve will both require
the adjustable
clamping device 82C (FIG. 7C 111),
[01071 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 therefrom
(however, the OSPS
system may be used as a stand-alone unit independent of any interface with
another computer).
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
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for fulfillment. The interface serves to parse/extract those oral medication
prescriptions from all
prescriptions submitted.
[0.108] 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 tilling 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 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. the
bulk
medicine container received from the pharmaceutical manufacturer and installs
one of several
possible container/syringe interface variations (as described above and
below), in all such cases
facilitating insertion of an oral syringe nozzle into the container. The
present system is adaptable
to filling syringes with each interface variation, The system may include an
optional motorized
capperidecapper station to assist with the removal of the manufacturer's cap
and the application
of a threaded or NBA interface,
b. Variable information such as container fill size, manufacturer's expiration
date,
and product: lot number are entered into the OSPS computer automatically as
much as possible
by bar code scan, or manually by the Pharmacy Technician under the supervision
of the
Pharmacist. First, the software guides the operator to scan the manufacturer's
barcode
However, the harcoded information is often incomplete. Any missing variable
information such.
as container till size, manufacturer's expiration date, and product lot number
can be derived and
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manually entered into the OSPS computer by the Pharmacy Technician.
c. If needed, the OSPS computer instructs the Pharmacy Technician which of the
container/syringe interfaces to select for recapping the medication container.
The OSPS obtains
this information from the medication database In addition, the OSPS may direct
the storage
location of the correct size container/syringe interface to illuminate,
unlock, or the likes as
described in further detail below.
d. The OSPS computer Auto-assigns an expiration date to the medication
container
based on either the manufacturer's expiration date or the expiration date
defined by pharmacy
policy. The pharmacy expiration date policy is determined by the date the
container is opened at
the medication container log in station plus the number of' days the
Pharmacist determines that
the medication should expire. The OSPS computer uses the date that is the
soonest to determine
the effective, medication container expiration date.
e. Software automatically prints a new unique 2D barcode label.
f The 213 barcode label is placed on the center of the base of the
container.
g. Software guides the operator to rescan the manufacturer's barcode on the
container label and the 21) barcode on the base of the container.
h. If scanning checks, the software guides the operator to place the
medication
container in a particular (logged) storage facility location.
[0:1091 The semi-automated Batch Fulfillment Process fox any of the self-
sealing caps described
herein comprises the following steps:
a. The software guides the operator to retrieve the medication container from
a
particular (logged) storage facility location (the medication container may
previously be logged
according to the method described herein with respect to the Medication
Container OrielltatiOn
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and Login Station).
b. The operator loads the medication container into the fill station.
c. The 2D barcode on the medicine container bottom is scanned to make sure
that all
medication issues relating to that medicine container have been addressed,
including correct
medication, refrigeration, expiration and light-sensitive storage,
d. The software guides the operator to pick a syringe of the proper color
and size.
e. The operator places the syringe in a syringe size/color station that
verifies that the
proper site and color syringe has been selected.
f. If the syringe size/color inspection passes, the software automatically
prints a
label for the syringe, and the operator manually applies the label to the
syringe. Alternatively, a
semiautomatic .flag labeler may be used, as described in more detail below.
g. The label i.s rescanned to ensure that the information is readable and
comet..
h. The operator scans the 2.D barcode on the syringe at the filling station.
lf needed, the medication container is shaken for the duration, intensity and
interval(s) required by the shaking mechanism to which the container is
attached.
3. The operator positions the syringe at the filling station.
It. The system/software automatically fills the syringe from medicine in
medication
container as described in more detail above and below.
L The operator caps filled syringe at optional semi-automatic capper,
m. The operator scans the syringe at the optional fill inspection station.
n. The system automatically inspects the syringe at an optional visual
inspection
station for proper weight and/or volume.
0. The operator scans the syringe at the bagging station,.
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p. The system/software automatically prints bag that the syringe will be
packaged in.
q. The software automatically scans the printing on the bag to make sure that
it is
correct.
r. The 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
101101 All medication containers and. medicines in those containers that have
been logged in,
each size syringe, each size conta.inerisyringe interface, the syringe labels,
syringe bags, print
media, etc. are automatically inventoried. As an item is used or consumed, an
accounting of the
amount of that item remaining is maintained.
[01111 Via the 2D barcodes on each syringe and medication container and the
scanning
operations at each station, Track. Trace and Validation software monitors and
documents the
entire process from the prescription approval by the pharmacist, log-in of the
medication
container through each step of the packaging process to ensure that the
syringe is filled and
packaged correctly. The Track, Trace and Validation software also tracks the
operation of the
equipment used in the process to ensure that each piece of equipment is
ftmctioning properly.
and provides error messages when any piece of equipment malfunctions. This
aspect of the
invention further results in the formation of an ''auclit" record of all
machinery involved in the
processes so that an operator, pharmacist, or technician may review a. log of
the machinery's
operations to pertbrin troubleshooting and/or quality checks.
[01121 FIG. I is a high level 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
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introducing mistakes. The present. method and apparatus is specifically
designed to avoid
mistakes and maintains comprehensive track-and-trace validation of each manual
step:
[01.131 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).
[0:1141 At step 710 the existing hospital host computer communicates the oral
medicine
prescription to the hospital pharmacy tbr approval. A pharmacist will
typically review it
[01l5 l approved by the pharmacist, 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.
10:1161 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 bareode, REID scan or
similar
identification scan (e.g., of the manufacturer's barcode) as described above.
The manufacturer-
supplied malicine container cap must be replaced, retrofit, or supplied by the
manufacturer in a
form that enables an oral. syringe to enter a center hole and withdraw an
amount of liquid from.
the medication container while the medication container is positioned upside
down, and the
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syringe S then removed from the container without leaking. There are fourteen
container/syringe
interface variations suitable for use with the present system (see FIGs. 5, 27-
34 and 44 and the
detailed descriptions associated with them). All this occurs at step 720 (FIG.
1).
[01171 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
medications:mantels: Location 1 -
No Special Handling of container; Location 2- Refrigeration Required;
Location. 3 - Light
Sensitive medication container (refer to FIG. 2 IL refs a-c). Each storage
compartment within
each location may be enclosed, by a magnetically-actuable 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. AU
these and other
suitable fonts 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 arc..
[01181 Similarly, at step 740 an inventory of packaging materials is
maintained, including empty
syringes in an array of sizes, syringe taps, labels (thr bareodes), and ink
foil printer ribbon.
[0.119.1 In support of the OSPS system, at step 730 a comprehensive medication
database is
maintained at the OSPS computer. The OSPS medication database includes the
following:
1. Medication information:
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a. Medication name.
b. Manufitcturers barcode number.
c. Written information that corresponds to manufacturer's barcode number.
d. Whether medication needs to be shaken, if so, the frequency, intensity,
and
duration.
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 21) barcode number assigned to that specific container. The
label
containing this information is placed on the base of the container.
b,. Fill size of that container in cubic centimeters (cc) or milliliters
(ml).
c. Current amount of product remaining in that container aller deducting
for
previous tills 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.
Pharmacy Policy Expiration Date. This is the 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 (i.e., Pharmacy Policy Expiration Date).
1.01201 Given all of the foregoing, at step 750 an operator may at any
convenient time commence
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the batch fulfillment process. The detailed substeps of the batch fulfillment
process 750 are
described below and illustrated in the block diagram of FIG. 3.
[0.1211 Referring back to FIG. 1, after each oral syringe has been filled and
packaged during
batch fulfillment 750, it is inspected and either rejected at step 760 or
approved at step 770.
[01221 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.
[0.123] A presently-preferred embodiment of the. physical system companentry
is described
below with reference to FIG. 2.
101241 As seen in FIG, 2, the pharmacy automation system 100 for packaging
oral syringes
generally comprises a standalone Medication Container Login & Orientation
Station I 1, with an
included array of container/syringe interface storage bins 12. In addition, a
proximate or remote
Storage Facility II 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. The final component of the system includes the syringe packaging
line III,
101251 In an alternate embodiment of the present invention, Swage Facility IT
of FIG. 2 may be
substituted with an automated medication storage cabinet (AMSC.) with rotary
shelves, such as
the commercially available MedCarouse10 sold by McKesson Automation Solutions,
or similar
models sold by TALYST, OMNICELL, SAPIENT AND US MEZZANINES. AMSC units such
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as these are currently being utilized in hospital pharmacies. These systems
automate the
medication management process from ordering the medication, stocking the
medication on the
system's rotating shelves, and presenting the medication to the pharmacy
technician at the time
the medication, needs to be utilized to fill the prescription on the OSPS.
Therefore, the accuracy
and efficiency of medication dispensing and inventory management is increased.
Aided by
rotating shelves, pick to-light, bar code scanning and comprehensive
integrated workflow
software, the AMSC systems guide the pharmacist to medication storage
locations, improving
picking speed and accuracy. AMSC systems such as the MedCarouselt can handle
storage of
refrigerated as well as non-refrigerated medicines.
[01261 In conjunction with the OSPS, an AMSC system would operate as follows:
1. Two AMSC systems would be utilized, one tbr non-refrigerated medications
and the
other for refrigerated medications. The containers that require light
protection would
be stored on the non-refligerated AMSC system.
2. After the medication container was oriented and logged in to the OSPS, the
AMSC
would assign a location to store that. medication.
3. The 21) bar code on the container would be scanned.
41. The Shelf That the medication was to be stored on would be positioned
in front of the
pharmacy technician. A light would appear over the location on the shelf on
which
the medication was to be stored.
5. The pharmacy technician would place the medication at that location.
6. At the start of the next OSPS production run, the OSPS would list the
prescriptions to
be filled by medication. This information would be sent to the AMSC(s).
7, The pharmacy technician would then remove the medication containers that
are
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presented and scan them. The medication containers would be kept in the same
order
in which they are removed by the technician. This order corresponds to the
order in
which the medication will be used to fill syringes on the OSPS.
8. After the production run, the medication containers would be returned to
the
AMSC(s) in the same order in which they were removed therefrom. The pharmacy
technician would scan the medication containers. The AMSC(s) would present the
pharmacy technician with the proper shelf and light the position to which the
medication container should be returned. The pharmacy technician would return
the
medication container to the indicated location in the AMSC(s).
[01271 A syringe storage bin 3 (see FIG. 2 BD is provided for storage of empty
syringes, and a
syringe label printer and labeler station 4 (see FIG. 2 III) is also provided.
Next, a syringe
size/color irsection station 11 is provided. These are followed by a syringe
filling station 5
with integrated medication container shaker assembly 820 (as described below).
An alternative
embodiment is a stand-alone shaking station.
[91281 At the tilling station 5 the medication container with
container/syringe interface 212 or
216 (see FIG. 5) is manually inverted and inserted. An overhead clamp lowers
against the
topside base of the medicine container to clamp the container against its
holder. This provides
an opportunity to inspect the medication container's 21) barcode (located in
the center of the
container's bottom) via the L.exanTM disc found in platform 79 (see FIG. 7A)
to verify that it is
the correct medication. The medication container is shaken if necessary. The
syringe's 21)
barcode is inspected and, if correct, the syringe is inserted into the
medication container via the
container/syringe interface. A plurality of servo-driven fingers (to be
described) grip and
stabilize the syringe S. The fingers manipulate the syringe plunger to prime
and fill the syringe.
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When all syringes have been filled with the medication, the medication
container is returned to
storage. This process continues until all syringes for that prescription
production run have been
filled.
[01291 Next, a semi-automated capping station 8 is used to place a cap (fed
from an inclined
capping chute 149) on the open tip of the filled syringe.
101301 .After each syringe S is filled and capped it is loaded into a vision
inspection station 9
which verifies the presence of the cap, the piston position within the
syringe, that the syringe is
filled with medication, and that an excessive number of air bubbles are not
present.
101311 Lastly a bag printing and sealing station 7 bags the filled syringe in
a barcoded bag,
[01321 The purpose and function of each of the foregoing stations 1-5, 7-9,
and 11 (see FIG. 2.
I, Ii, up will become clearer in the context of a detailed description of the
Medication. Container
Orientation and Log-In Process (step 720), and Batch Fulfillment Process (step
750).
Medication Container Orientation and Log-1n Process (step 720)
[01331 The OSPS system guides the operator in properly equipping and storing
each hulk
medication container. As described above, the manufacturer-supplied medicine
container cap
must be replaced, retrofit, or supplied by the manufacturer in a form that
enables an oral syringe
to enter a center hole and withdraw an amount of liquid from the medication
container while the
medication container is positioned upside down, and the syringe S then removed
from the
container without leaking. Thus, at step 720 (FIG. I) the manufacturer-
supplied medicine
container cap may need to be provided to specification, or replaced or
retrofitted with a
container/syringe interface to provide a penetrable orifice. As described more
fully below the
retrofit. may be accomplished in a number of ways. Thus, the present invention
contemplates.
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fourteen (14) container/syringe interface variations: (1) a valve-less press
in bottle adapter
(NBA) 210; (2) a self sealing NBA (SSP1BA) 21.2 with an integral valve
(typically, either a
linear or a Z-Shaped slit) 2.13; (3) a standard manufacturer-supplied (BaxaTM
or Baxa equivalent)
valve-less medicine container cap 214 with opening; (4) a modified
manufacturer-supplied
(Baxa rm or Baxa equivalent) medicine container cap 216 that is retrofit to
include an integral
valve 225 (typically, a duckbill valve); (5) a two-piece cap comprising an
outer portion 220 with
a common outer diameter fOr all standard sizes of inedic.ation container, and
a self-sealing insert
212; (6) a cap 221 comprising a common outer diameter for all standard sizes
of medication
container and having an integral self-sealing insert 212; (7) a modified
manufacturer-supplied
(Baxam, or Baxa equivalent) medicine container cap 214 that is retrofit to
include a non-integral
push-in tip 223 for interfacing with Luer lock, oral syringes; (8) a. modified
MBA .210 that is
retrofit to include a non-integral push-in tip 223 for interfacing with Luer
lock oral. syringes; (9)
a modified manufamrer-supplied (Baxa rm or Baxa equivalent) medicine container
cap 214 that
is fitted with a push-pull cap 224 for interfacing with Luer lock oral
syringes; (10) a modified
manufacturer-supplied (BaxaTM or Baxa equivalent) medicine container cap 214
that is retrofit
with an integral push-pull cap 224 for interfacing with Luer lock oral
syringes; (11) a modified
NBA 210 that IS fitted with a push-pull cap 224 for interfacing with Luer lock
oral syringes; (12)
a modified NBA 210 that is retrofit with an integral push-pull cap 224 for
interfacing with Luer
lock oral syringes; (13) a cap 226 comprising a common inner diameter for all
standard sizes of
medication container, fitted with an integral or separable valve 225
(typically, a duckbill valve),
and having grooved rings to facilitate handling, positioning, etc. by the
system according to the
present invention; and/or (14) a valveless NBA that is retrofit to include an
integral valve 225
(typically, a duckbill valve). Again, all fourteen variations as shown in
FlGs, 5, 27-32 and 34
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and 44 are described below in detail above.
[01341 It is envisioned that medication containers may be provided to the
hospital pharmacy for
use with the present system in such a way that will minimize or possibly
eliminate any need for
the Medication Container Orientation and Log-In Process (step 720). For
example, medication
containers may be provided for use with one or more of the following features:
I) standardized caps with self-sealing valve (such as, for example, the above-
referenced
BaxaTm or lilaxa-equivalent medicine container cap with penetrable opening);
2) standardized containers;
3) barcoded or RF1D-coded containers that already contain the information that
a pharmacy
technician would otherwise need to input during the Medication Container
Orientation
and Log-In Process (step 720); and/or
4) any other means of providing the intbrmation that a pharmacy technician
would
otherwise need to input during the Medication Container Orientation and tog-In
Process
to the OSPS database and system, such as, i.e., via the Internet.
101351 A. combination of all three features listed above would minimize or
eliminate the need for
the Medication Container Orientation and Log-1n Process (step 720). However,
for purposes of
complete description it will be assumed that such features are lacking in OEM-
supplied
medication containers and so the Medication Container Orientation and Log-In
Process (step
720) will herein be described in detail.
[01361 Referring now to FIG. 4 which is a flow diagram of the Log-In process
for the valved
P.113A 212 (see FIG. 5), at step 900, medication containers are received from
a contract packager
or pharmaceutical manufacturer.
[01371 At step 910, medication containers are delivered to the OSPS Medication
container
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Login & Orientation Station I (FIG. 2).
101381 At step 915 the pharmacist and operator logs into the local OSPS
computer.
101.391 At step 925 the manufacturer-provided medication container barcode is
scanned.
'Variable information is entered into the system by the pharmacy technician.
101401 At step 935, the labeler shown at the Medication Container Login &
Orientation Station I
(see FIG. 2 generates a 21) barcode label which includes the location that the
medication
container is to be stored at. The 2D bar code is manually placed on the bottom
of the container
(or on the container/syringe interface) at step 945.
101411 At step 940, the bar code label is automatically seamed/inspected
immediately after
printing to verify that its contents are correct and the bar code ID is stored
in the OSPS database.
[01421 At step 945, the bar code label is adhered to the base (bottom) of the
container,
[01431 At step 950, both the 21) bar code placed on the base of the container
and the
pharmaceutical manufacrurees barcode are scanned using a scanner resident at
the Medication
Container Login & Orientation Station I and the manufacturer's bar code on the
medication.
container label are scanned to verify that. the correct 21) bar code was
placed on the base of the
container.
101441 At step 955 all general and container specific information, inclusive
of Product
Information and label photograph, is recorded in the local OSPS computer
database, including
the storage location of the bulk. container.
101451 At step 960, the OSPS local computer assigns an expiration date to the
medication
container. The expiration date is predetermined by pharmacy policy. The
pharmacy policy
expiration date is determined by the date the container is opened at the
Medication Container
Log In Station I plus some number of days after which the Pharmacist
determines that the
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medication should expire.
[01461 At step 961, the medication container cap is removed from the container
by the operator
and is set aside for later reuse.
[01471 At step 962, the OSPS local computer instructs the pharmacy technician
regarding which
size adapter cap to obtain and insert into the container neck. To guide the
operator, the box 12.
containing the comet size adapter cap is preferably illuminated as shown in
FIG, 2.
[01481 At step 963, the pharmacy technician inserts the adapter cap onto the
medication
container. In some embodiments, the original medication container cap from
step 961 may be
replaced on the medication container.
[01491 At step 965, the operator manually stores the medication container in
the location
specified by the OSPS local computer (see FIG, 2 11).
[01501 At. step 970 if the container is to be stored in the refrigerator, an
optional log-iniloa-out
control system and procedure is available to verify if the container was
refrigerated satisfactorily
(see. FIG. 2 II b). 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.
101511 At step 975 if the container is to be stored in a light protected
storage area, an optional
log-inilog-out control system and procedure is available to verify if the
container was stored
appropriately(see FIG. 2 II c), 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, and will alert the Pharmacy Technician to
remove and discard
that container.
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Batch Fulfillment Process 750 (FIGs. 1-3)
10152) With reference both to FIGs. 2-3, at step 800 a pharmacist must log
into the OSPS local
computer to use the system.
[01531 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 limes a day.
c. The Local OSPS Computer first sorts all the batched prescriptions by type
of
medication. The order of the queue may be in the discretion of the pharmacist
(i.e, alphabetically by medication 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 cheeks to ensure that there is a sufficient amount of product for
each
medication required to complete the batch.
e. If a doctor orders, for a single patient; multiple same doses of the same
medication to be administered at different times, all doses can be filled
together
during, a single production run or in separate production runs at the
discretion of
the Pharmacist, in a preferred embodiment, all prescriptions for one
medication
are filled at the same time, followed by all prescriptions for the next
medication.
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etc.
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.
c. The prescription order indicates that the prescription needs to be
administered
soon to the patienl
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.
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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 operated on a manual basis whereby
the prescriptions are entered into the system under the Pharmacist's
supervision.
101541 One skilled in the art should understand that other operational modes
are possible, for
example, 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.
[0155f At step 811, by way of example, Patient Specific ¨ Hospital Directed is
selected and the
process is herein described accordingly.
[01561 At step 815 an operator (pharmacy technician) logs in.
101571 At step 820 the OSPS local computer directs. the operator to select the
appropriate
medicine container from Storage Facility 2 (see FIG. 2 II), and an appropriate
syringe from
storage bin 3 (FIG. 2 III).
101581 At step 825, the operator retrieves the appropriate medicine container
from Storage
Facility 2 (see FIG. 2 II) (under system guidance) and inverts and installs it
at the syringe filling
station 5 (see FIG. 2 114
[01591 At step 826, the barcode on the bottom of the container is scanned to
make sure that all
medication-related issues have been satisfied (refrigeration, shaking, light-
sensitive storage,
expiration, etc.).
[01601 At step 830, the pharmacy technician places the syringe. S on the
inspection station cradle
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(see FIG. 2, ref. 11). Alternatively, the inspection station may he omitted
and the syringe may be
inspected at the labeling station 4.
[0.1611 At step 835, the system automatically inspects the syringe for proper
size based on a
syringe body measurement (described below), to verify that the correct:
syringe has been
selected. Proper color of color-coded syringes is also verified.
[0162) At step 837, 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 21) bztrcode though other labels such as RE!!) may be used. The
label is adhered to
the syringe barrel. Alternatively, a semi-automatic flag labeler is used as
described below.
10.1.63) After printing the label, per step 837, at step 838 the label is
inspected to ensure that its
content is correct..
01641 At step 839, the label is affixed to the syringe S (where a semi-
automatic flag labeler is
used, the flag is adhered to the syringe S automatically by the labeler),
[0165) At step 840, the operator manually places the syringe at the syringe
filling station 5 (FIG.
2).
10166j At step 841 (if required), the shaking mechanism 820 (FIG. 2 III)
shakes the medication
container before any medication is drawn from it into the syringe.
[0.167) At step 845, the syringe is filled at the filling station 5. The OSPS
system automatically
primes and fills the syringe with the medicine by insertion and withdrawal of
the plunger.
[0.168.1 At ste.p 848, the syringe is capped at the semi-automatic capping
station 8. The capping
station caps the syringe and presents it to the operator.
[0169) At step 850, the operator positions the filled syringe S at the vision
inspection station 9
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(FIG. 2, III) and at step 855 the syringe is inspected for correct vision
metrics. These actions are.
logged.
101701 At step 860 a syringe bag is .printedlbarcoded at bag printing and
sealing station 7 (FIG.
2, Ill), and at step 861 the system verifies the bag is printed correctly. If
so, the operator is
permitted to insert the filledicapped syringe S into the barcodedllabeled bag.
101711 At step 865 the pharmacy technician inserts the syringe S into the bag
(FIG. 2,114
[01721 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.
101731 As mentioned at Note I (FIG. 3), 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 bulk medication container, to insure that the packaging process
is occuffing
correctly and to compile an audit trail of the cumin and past locations (and
other information)
for each syringe-. If all process steps 800-870 occur correctly, the syringe S
is approved and
made available for distribution to the patient (see FIG. I, step 770).
[01741 If a process step fails then as seen at step 760 of FIG. I the syringe
or medicine container
is rejected (and barred from distribution to the patient).
101751 The core method and possible variations are herein implemented in
several detailed
embodiments of a system suitable for preparing patient-specific doses of'
liquid medications into
oral syringes on a just-in-time basis. 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. For example, the syringe S handling can be
accomplished in
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numerous ways, the simplest option being described above in regard to FIGs. 2-
3. In this
instance, one operator packages one syringe at a time sequentially from
syringe selection through
bagging that syringe S until each of the syringes S that need to be filled
with a specific
medication are packaged (see FIG. 2), However, several syringe handling
variations are given
below.
Alternative Swirl LK! Hand i Options
[01761 As mentioned above the handling of the syringes S on the packaging line
can be
accomplished in numerous ways, the simplest option (Option I ) being described
above with
regard to FIG. 3. However, productivity of the packaging line can be increased
using other
syringe handling variations. Some of the alternate syringe handling options
are as follows:
101771 Option .2 ¨ Similar to Option I but two operators .process/package some
or all of the
syringes S at one time as a group, at each of three grouped stations, wherein
a first operator
processes/packages some or all of the syringes S at one time at station I ,
then moves to station 3
while a second operator processes/packages sonic or all of the syringes S at
one time at station .2.
As shown in FIG. 22B, for Option 2 a first group of stations includes syringe
selection from the
syringe storage location 3, inspecting the syringe for size and color, and
labeling the syringe. A
second group of stations comprises filling and capping the syringe at syringe
filling station 5 and
capping station 8. A third group of stations comprises inspecting and bagging
the syringe at
vision inspection station 9 and batwing station 1% All of the syringes S that
are to be filled with
the same medication would be processed collectively at the first group of
stations by operator I
and then placed in a first receptacle to be picked. up by the second operator.
While this is taking
place, operator 2 may begin to process scone or all of die syringes from the
first receptacle at. the
second group of stations, placing processed syringes in a second receptacle.
When operator I
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has completed the tasks of selecting a syringe, verifying that it is correct,
labeling the syringe and
verifying that it was labeled correctly, he or she may move to the third group
of stations to
proms some or all oldie syringes in the second receptacle until all of the
syringes are packaged
with the specific medication. Then the next medication would be packaged. To
facilitate this
grouped approach, as an alternative, FIG. 2.2A shows a multiple syringe
compartment tray which
slides along a track to shuttle multiple syringes S back and forth to
successive grouped stations
and may be used in place of first and second receptacles.
[0.1781 Option 3 Similar to Option I but one operator processes/packages some
or all of the
syringes S at one time as a group, at each of three grouped stations before
proceeding to the next
grouped station. Similarly to Option 2, in Option 3 a first group of stations
includes syringe
selection from the syringe storage location .3, inspecting die syringe for sin
and color, and
labeling the syringe. A second group of stations comprises filling and capping
the syringe at
syringe filling station 5 and capping station 8. A third group of stations
comprises inspecting
and bagging the syringe at vision inspection station 9 and bagging station 7.
All of the syringes
S that are to be filled with the same medication would be processed
collectively at the first group
of stations 3, 4, then ad of the syringes would be processed at the second
group of stations 5, 8,
and then all of the syringes would be processed at the third group of stations
7, 9 until all of the
syringes are packaged with the specific medication. Then the next medication
would he
packaged.
101791 Option 4 - Similar to Option 2 but three operators are utilized, one at
the tint group of
stations 3, 4, one at the second group of stations 5, 8, and one at the third
group of stations 7, 9.
To facilitate this, a carousel conveyor 325 is shown in FIG. 23 with multiple
trays 3.27, each
containing 3 - 5 syringe compartments per tray. The trays 327 rotate around
the carousel 325
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past three operators positioned one per each group of stations.
[0180.1 Option 5- Similar to Options 1, 2 and 3 but two operators are situated
around a lazy
Susan (carousel-like) disc 342, as shown in FIG. 24. Operator I selects,
labels and inspects
empty syringes S for size and color and places them in trays 343 located
radially arranged on the
disc 342. Additionally Operator I collects the medication bottles and either
stages them, or an
upper tier 345 of the disc 342 retains them for the second operator.
[01811 Operator Two receives the syringes S and medication bottles via, the
rotating disc 342 and
performs the filling and capping at stations 5, 8, respectively. Operator Two
may also do the
filled syringe inspection at station 9, At this point it may be necessary to
opt for an Operator
Three to do the filled syringe inspection at station 9. Operator Two or
Operator Three may then
place the Filled, Capped and Inspected syringe S onto the rotary disc 342 to
be indexed back to
Operator One for bagging at station 7,
[01821 Option 6-Similar to Option 4 however this system utilizes (3)
operators. As seen in FIG.,
25, Operator One inspects empty Syringes for size and color, applies a flag
label to syringe S and
places it on the lazy Susan disc 342 in trays 343, Operator Two, places the
empty inspected
syringe S into the filling station 5 and tills, caps and places them onto the
disc 342 for transport
to Operator Three. Operator Three inspects the filled syringe for correct
dosage. The syringes S
are then conveyed back to Operator One for bagging at station 7,
101831 Referring back. to FIG. 2, each station of the pharmacy automation
system I (X) for oral
syringes is described below in more detail.
Medication Container Login & Orientation Station I.
[01841 The first station in the process of the present invention is Medication
Container Login &
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Orientation Station I (see FIG. 2 I) at which the bulk medicine is prepared
for use in the overall
system 100. Medication Container Login & Otientation (MCLO) Station I 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 at optional cappingidecapping station 93, refit and/or retrofit
them as necessary
with a container/syringe interface (as will be described) at cappingidecapping
station 93, and
optionally photograph them using a label photographing station 98. All of the
scanner 95, data
entry terminal 96, and label printer 97 are commercially available components.
MCLO Station I
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. To he. able to do this, manufacturers must supply a
specialized cap or
insert, or the pharmacy technician must replace or supplement the manufacturer-
supplied cap
with a container/syringe interface.
[01851 Referring back to FIG. 2 1, at MCI.,0 Station 1 a number of bins 12 are
provided for
storing various sizes and configurations of container/syringe interfaces 210,
212, 214, 216, 220,
221, --226, and the Baxam-type or PIRA variations for caps 223 and 224, both
integral and
separable, (see Wis. 3, 27-34 and 44) 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 container/syringe
interface 210, 212,
214, 216, 220, 221, 226, 223 and 224 and syringe S selections) may be
"system.guided" as
described above. Each container/syringe interface storage compartment 12 (see
FIG. .2 .1) may be
enclosed by a magnetieally-actuable door so that access to each location may
be electronically
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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.
[0.1.861 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-specifie 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. The exact container 104 location is provided to
the operator via
OSPS system 100 guidance who retrieves the container from the Storage facility
2. Again the
Storage facility 2 may be fined 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.
10187i In operation, and as described above with regard to FIG. 4 (medication
container
orientation and log-in process steps 961-963), the OEM caps on medication
containers 104 are
manually removed and replaced with an applicable adapter cap, i.e., a valved
NBA 212 (see
FIG. 5). The OSPS local computer instructs the operator Which of the valved
adapter cap sizes
in storage bins 12 (FIG. 2) to select for insertion into the medication
container 104. (step 963).
The labeler 97 generates a 213 barcode label which includes the location of
Storage facility 2 (see
FIG. 2 II) that the medication container 104 (see FIG. 2 I) is to be stored
at. The operator places
the 213 bar code on the bottom of the. medicine container, and the 2D barcode
is scanned by
scanner 95, and optionally photographed using a label photographing station
98. All general and
container specific information derived by scanning or supplemental data entry
at data entry
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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 OS:PS
computer. If the container is to be stored in light protected storage 2 11 c
or refrigerated storage 2
II 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 6614 2 with container/syringe interface
2.10, 212, 214, 21.6,
220, 221, 226, 223 and 224, (see FIGs. 5,27-34 and 44) applied and load it
into the Ring station
where the 21) 'bar code label on its base is automatically scanned by scanner
121 at the filling
station 5. The medicine is verified by the scanning as to proper content,
available fluid volume
and other attributes before being filled at filling station 5.
101881 A second station in the packaging process according to the present
invention is a storage
bin 3 (see FIG. 2 111.) 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 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
ease of a wrong selection. In still other embodiments the syringe storage 3
Selection may be
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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 %flowing standardized oral syringe sizes: 0.5m1, imi, 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).
10189I A third station in the filling and packaging process is the syringe
size/color inspection
station 11 which verities that. the correct syringe S has been selected. The
syringe size/color
inspection station 11 is described more fully below with regard to FIG. I 5A..
[01901 The fourth station is a flag label printer/applicator 4. After
determining that. the syringe
S is the proper size and color, the operator inserts the syringe into syringe
label primer/applicator
4. As described above, relative to FIG. 3 (step 837), 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 of this information in the OSPS database. The
label. includes a 21)
barcode though other labels such as RFID may be used. The label is inspected
to verify the
accuracy of the printed information before it is attached to the syringe S.
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
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barrel of syringe S. Alternatively, the flag label may be applied manually by
the operator. A
portion of the label around the barrel must be transparent to permit dosage
markings of the
syringe to be clearly visible.
[01911 As an alternative to the flag label printer/applicator 4, an on-demand
label printer may be
used which prints a patient-specific, label on demand. This arrangement would
require the
operator to manually apply the label to the syringe After the label is
printed, the operator will
verify that the syringe was labeled correctly. This option is less expensive
than the use of a
semi-automatic flag label printer/applicator 4 and will be offered as an
option for substitution of
same.
[01921 A fifth (optional) station is a medication container shake station for
automatically
shaking the medicine container when necessary (see FIGs. 16A. and 1613), A.
shaking mechanism
820 integral to the tilling station 5 is described below. An alternative,
remotely-positioned
medication container shake station 6 is described more fully below with regard
to FIG. 17 while
a. standalone or integral shaker module is described mow fully below with
regard to FIG. 16A.
[01931 For certain medications, such as those in the form of emulsions,
liquids containing
paniculates or other non-homogeneous liquids, shaking is required prior to
filling to render the
mixture homogeneous. Within this category of medications, Certain medications
need to be
shaken at more frequent intervals, and with a greater intensity, than other
medications based on
the unique characteristics of each medication. Embodiments of the instant
invention comprise an
electronic medication database accessible by the OSPS-S system. information
about any
required shaking protocols for each medication may be stored in the medication
database in
association with the relevant medication(s). At the Medication Container
Orientation and Login
Station (FIG. 2 (I)) described herein, the method according to the present
invention may involve
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the printing of a 213 harcode for each medication bottle which, when scanned
at the filling station
5, provides the OSPS-S system with the required shaking protocol, if any, for
the scanned
medication. This will then prompt the OSPS-S system to cause the integral
shake station 820 to
shake the medication container before or after the filling operation with the
frequency, intensity
and in the intervals as required for the given medication. This process
advantageously prevents
medication that is pone to settling or separating from doing so such that each
syringe contains
the proper composition of medication.
10.1941 The sixth station is the syringe filling station 5 for filling the
syringes S. The operator
positions the empty syringe S (step 840) at the syringe filling station S. A
scanner 121 is resident
at the syringe .filling station 5 to automatically scan the machine readable
label on the bottom of'
the container 104 to again verify that the selected item is correct The hand-
held seamier at the
fill station 5 scans the label attached to the syringe to verify that the
appropriate. syringe is being
used. The medicine container 104 and the syringe S are loaded into the filling
station 5 in
various ways dependent upon the container/syringe interface that is used. The
fourteen
containerlsyringe interfaces and associated procedures for use are discussed
in more detail above
and below. The system automatically fills the syringe S with the medicine by
calibrated
withdrawal of the plunger.
[01951 The seventh station is a visual inspection station 9 which comprises
optical inspection to
optically determine if the syringe is filled correctly. On this basis the
System. 100 accepts or
rejects the weighed/inspected syringe,
[0.196.1 FIG. 6A is a perspective view of an exemplary vision inspection
station 9 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
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syringe tip is filled with product, and also checks for bubbles in the
product.
[01971 With respect to FIGs. 6A and 68, the illustrated embodiment of the
vision inspection
station 9 generally comprises a flat base 92 with vertical syringe-mounting
plate 93 at one end,
caddy-corner to a vertical camera mounting plate 94. MD imager 330 is mounted
overhead on
a camera-mounting bracket 95 extending upward from the camera mounting plate
94. A syringe
holder 96 protrudes from the vertical syringe-mounting plate 93 and suspends a
syringe by its
cap (two yoke fingers under the cap). An optional syringe clamp 99 may be
provided opposite
the syringe holder 96 for clamping the syringe therein. In its simplest form
(shown), syringe
clamp 99 is a spring-biased jaw that clamps against holder 96 to secure the
syringe. A backlight
panel 97 resides directly behind the syringe S (beneath syringe holder 96).
Two side-mounted
lights 98 provide frontal illumination.
[01981 In operation, the vision inspection station 9 establishes and maintains
a "Reference Point"
on each syringe which is consistent for all syringes despite size, nozzle
offset and other
variable& in accordance with the invention the reference point is selected to
be just below the
syringe tip at its intersection with the top of the syringe body. Since the
syringe cap covers most
of the syringe tip, and That tip volume is never dispensed, the tip can be
ignored from any vision
reading taken. The -filled and capped syringe S is preferably held stationary
in the spring-loaded
yoke fingers of syringe holder 96 by its cap, while the backlit camera CCD 330
measures from a
reference point to the seal ring of the syringe S plunger. Since the syringes
are hung by their
caps within a common yoke they will all have the same zero reference point,
despite varying
sizes. The reading from the "Reference Point" downward to the seal ring of the
plunger
comprises a numerical dimension for the specific syringe S size relative to
the prescribed dose
(the size selected being the next larger size in excess of the dose). Once
taken, the OSPS
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computer compares the reading to a predetermined value associated with that
syringe size and
every increment on the syringe. For example, if a 10 ml dose is prescribed the
OSPS computer
will recommend a 20 ml syringe, in which case the distance from the "Reference
Point"
downward to the seal ring of the plunger (when fully inserted) should be 32.75
mm or 1.289".
This way, given knowledge of the prescribed dose and the syringe size, the
system can
accurately determine if the till dose is correct. Otherwise it will be
rejected. The accuracy of fill
should be 5% of target. In addition, the vision inspection may also include
phase-contrast
imaging to measure bubbles in the syringe. Phase contrast imaging exploits
differences in the
refractive index of the contents to differentiate bubbles. Some bubbles are
tolerable, but too
many are not. The vision inspection may employ phase-contrast imaging as a
bubble check.
This same process is used to determine if the syringe is "short filled" based
on differences in
shading. Any voids or bubbles are interpreted as a mixed pixel count in either
light or dark
depending on the opacity of the medication derived from the OSPS computer
database. If the
syringe volume inspection device 9 determines that the syringe S is filled to
the correct volume
with an acceptable amount of bubbles and no voids, it will be accepted. An
acceptable
bubble/void percentage is +1- 2%. Optionally, a digital photograph of the
filled syringe may be
taken and archived for track and trace purposes. lit a preferred embodiment,
the color of the
light may be changed to give the greatest possible contrast. over liquids of
different colors and
opacities. The lighting color may be determined by the vision inspection
station. 9 based on a
scan of the 20 barcode on the syringe to be inspected.
[01991 The illustrated embodiment reduces the footprint (size) of the vision
inspection system 9
using a mirror to break up focal distance into shorter lengths (here two,
though additional mirrors
may be used). Specifically, the overhead camera 330 view is reflected off a
mirror 333 mounted
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to wall 94, and is then focused on the syringe S being inspected.
[02001 FIGs, 6C and 6D show two alternative articulating designs for the
backlight panel 97
which resides directly behind the syringe S (beneath syringe-holder 96), both
perspective
sequential views, which facilitate easier loading of the syringe S from
behind. In FIG. 6C, the
syringe-holder 96 is mounted from a suspension or other non-obtrusive bracket
to facilitate
rearward access. The backlight panel 97 is mounted behind the syringe-holder
96 on hinges or
pivots 198 as shown, to allow the backlight panel 97 to be opened or closed
like a door. As
shown in the sequence, the operator places the filled, capped syringe S into
the syringe-holder 96
at (1)3 closes the backlight panel 97 at (2), the CCD imager 330 images the
syringe S against the
backlight panel 97 at (3), and the backlight panel 97 is reopened at (4) and
the syringe S
removed.
102011 Fla 6D shows a guillotine-style backlight panel 97 slidably mounted on
a pair of
spaced-apart vertical rails 195. Backlight panel 07 moves up and/or down
within rails 195. As
shown in the sequence, the operator places the filled, capped syringe S into
the syringe-holder 96
at (1), and closes the backlight panel 97 whereupon the CCD imager 330 images
the syringe S
against the backlight panel 97 at (2). The backlight panel 97 is then reopened
and the syringe S
removed.
[02021 As still another alternative, the inspection may be accomplished. with
a check-weigh scale
to weigh and/or inspect the filled syringe S to verify the syringe is as
labeled. In this ease, the
OSPS software calculates target weight based on the fill size in cc's and
multiplies by the
specific gravity to derive weight. The specific gravity of each medication is
stored in the OSPS
database along with the percentage +1- % 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,
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102031 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 medication is
stored in the OSPS database along with the percentage (+/- %) deviation that
is acceptable for the
aettlai fill weight if the actual fill weight is in the target range, it is
accepted. If not, it is
reiected.
102041 An eighth station 8 is the semi-automatic syringe capping station
described below in
detail with regard to FIG. 10. The syringe capping station 8 facilitates
accurate placement of
syringe caps onto filled syringes S.
102051 The ninth station is a bag printing and sealing station 7 (see FIG. 2
114 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
filledlcapped syringe S in the bag, the system confirms that the syringe was
placed in the hag,
and the bag is then sealed.
1.02061 if all the steps are completed correctly the syringes are distributed
for administration to
the patient.
[02071 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.
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102081 At initial MCLO Station I an operator prepares bulk medicine containers
for use at the
automated syringe filling station 5. Preparation entails applying one of the
above-described
container/syringe interfaces. Again, each medicine container is pre-labeled
with a unique
identifying number, for example, in barcode format adhered to the bottom of
the container.
Preparation of the container 104 also includes scanning, verification,
optional photographing,
and recordation of container 104 label information including content
information (name,
manallicturer, full volume, concentration, etc.), batch or production
information, and expiration
information 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 till dispense cycles).
102091 Each barcode (or possibly II FM tag or other label) preferably
references the following
infomiation:
= Batch number
Expiry date
= Storage instructions
= Product name
= Strength
= Name of the active ingredient(s)
= Dose form
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= Warning statements
= FDA number
= Des product need to be shaken betbre use? If so, how often?
= Does product need to be refrigerated before use? If so, temp?
= Does product need to be protected from lot?
= Volume of original bulk medication container?
10210I The intbrmation 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
barcode label on the base of the container, which includes the container
identifying number
assigned to the container 104 in the medication track and trace-database. It
is also important that
each container 104 is marked in both human and machine readable forms (Le.
text, barcode or
RFID tag) as to the type and concentration of the medication it contains along
with various other
informations to enable visual inspection.
1021.11 The containeitibottles 104 are typically manufacturer-supplied
although custom
containers/bottles may be used for purposes of the present system. if the
storage containers or
bottles 104 are provided by the manufacturerõ 20m.m, 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
mite,
10212i With regard to filling station 5 in FIG. 2, 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
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amount of a gas (such as air) 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 he 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.
102131 Referring back to FIG. 2, the operator returns the prepared medicine
container 104 with
its containerisyringe interface 210, 212, 214, 216, 220, 2.21, 226, 223 and
224 in the medicine
Storage Facility 2 Where it remains until 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 3
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.
[02141 After retrieving the syringe from syringe store 3 (see FIG, 2 of
empty syringes S to be
filled as described above, the operator inserts the syringe into a station
that includes a syringe
color/size inspection device 11 and a syringe label printer/applicator 4.
[02151 FIG. 15.A is a perspective view of an embodiment. of the syringe
size/color station 11A
which verifies that the correct syringe size (0.5m1, 1ml, 3m1, 5m1, 10m1,
20m1õ 35m1, and 60mI))
has been selected by the operator. One skilled in the art should understand
that syringe
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size/color inspection station 11 A may be placed anywhere but is best placed
proximate the filling
station 5. The illustrated syringe size/color inspection station 11A
essentially comprises a set of
automatic electronic calipers connected to the OSPS Computer. More
specifically, a support
surface 1101 is formed with a pair of aligned Slots 1103, 1104. A stationary
cradle comprises a
pair of spaced-apart yokes 1102a, 1102b fixedly mounted on the support surface
1101 on
opposite sides of the slots 1103, 1104 for supporting the syringe S in a
horizontal position. A
pair of articulating caliper fingers 1105 protrude upward through the slots
1103, 1104 to embrace
the syringe S on both sides. Caliper fingers 1105 are driven by an underlying
caliper drive
mechanism connected to the OSPS Computer which moves fingers 1105 into contact
with the
syringe S after the shuttle 5s has deposited the syringe S onto the yokes
1102a, 1102b. The
caliper fingers 1105 rise to a height higher than the center of the largest
syringe size, and in.
operation the fingers 1105 close around the body of the syringe S until a
force is sensed
(indicating contact with the syringe). At this point a measurement of the
syringe body is taken
(the distance between fingers 1.105 is calculated) to verify that the correct
syringe S has been
selected. Oral syringes are often color coded in translucent colors for ease
of identification, For
example, oral syringes may be a highly visible amber color to distinguish its
contents as an orally
administered medication. To vet* color, a color inspection camera 1107 is also
connected to
the OSPS computer and may be mourned in either of yokes 1102a, 1102b to image
the color of
the syringe S. A 3-CMOS imager is preferred for this application to capture
ROB pixel data,
which is compared by OSPS Computer to a color lookup table or subjected to
another color-
matching algorithm to verify the proper syringe color. If size and/or color
are correct, labeling
andior further processing of the syringe S will take place.
[02161 FIG, 1513 is a perspective view of an alternate embodiment of a syringe
size/color station
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11B which verifies that the correct syringe has been selected. Embodiment 11B
comprises a
parallel pneumatic grippe'. 1201 fixedly mounted at a downward incline within
a supporting
structure here comprising opposing vertical plates 1210, 1212 connected by a
cross-bar 1214.
There are a variety of commercially-available pneumatic grippers available in
parallel, angular,
radial and concentric versions, and in this instance a parallel version is
used, such as a Rexrodir"
GSP precision parallel pneumatic gripper. Opposing syringe gripper jaws 1220
are attached to
the existing gripper 1210 arms, each jaw 1220 comprising a downward extension
to a
horizontally-disposed finger. The opposed horizontal fingers 1220 are formed
with inwardly-
disposed vertical grooves to provide a proper grip on the syringe barrel,
while holding it
vertically. A linear variable differential transformer (LVDT) 1225 (also
called a differential
transformer) is mounted in plate 1.210, and its sensing piston is threaded
into a collar 1227
secured to the opposing jaw 1220 for measuring linear displacement (position).
The LVDT 1225
is connected to the OSPS Computer and measures the distance traveled by the
jaw 12.20 as it
closes around a syringe S. The LVDT 1225 takes monitors an input voltage
differential from a.
starting position to a final position after gripping the syringe S. and
calculates syringe size from
distance travelled by the jaw 1220. As above, to verify color a color
inspection camera 1107 may
be mounted in either of plates 1210, 1212 to image the color of the syringe S
and thereby ensure
that size and color are correct, such that labeling andior further processing
of the syringe S may
take place. One skilled in the art should understand that the syringe
measurement system118
may be integrated as part of the syringe filling station 5 (see FIG. 2 111)
rather than as a
standalone station as shown in Fla 158, thereby consolidating the size/color
inspection fimetion
with the filling operation.
[02171 The labeler 4 is in communication with the central controller and
prints self-adhesive
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labels 'bearing in&rmation 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
dearly visible.
Alternatively, an on-demand label printer, for manual application of the label
to the syringe, may
be used in place of labeler 4.
102.181 IA is an enlarged perspective view of a semi-automated syringe fill
station 5 for
filling the syringes S. Prior to inserting the syringe into the syringe
filling station 5, the operator
will have selected from the Storage facility 2 the appropriate, prepared
container 104 with a
valved PIRA (see FIG. 5) from which to dispense the proper medicine into the
syringe S. The
operator first inverts and then inserts the prepared container 104 into yoke
82C (see FIG. 7C III).
The syringe S is then manually loaded by the operator into the syringe filling
station 5,
preferably with the plunger partially withdrawn from the 'barrel. The syringe
Sfplunger
combination is inserted into the medicine container. Several support
fixture/yoke variations are
envisioned.
102191 As seen in FIG. 8, 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
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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,
plunger lifting arm
128 and plunger flange 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/ nr2, 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 OS.PS computer then controls the
movement of fill arms
110, 111, 112 and plunger lifting arm 128 in accordance with the calculated
distance F1, and may
also account for other variables such as medicine viscosity, volume of fill,
etc, to optimize either
the linear travel distance 11 or the filling force exerted or filling time
taken along that distance.
[02201 With reference to FIG, 9, 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 1.29 riding on a pair of ball
slides 122 on a set of
guide rails 123 vertically oriented with the housing 895 (of FIG, 7A),
Vertical movement of
each base member 129 on the guide rails 123 is controlled by a linear servo
124 situated below
and extending into the housing 895. Each arm 110õ 111õ 112 is also provided
with a horizontal
reaching element 127 slideably mounted horizontally to each base member 129 so
as to ride up
or down the guide rails 123 with the base member 129 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 129 and engaged to the proximate reaching element 127, each which
is itself
mounted via a horizontally oriented ball slide assembly 1.26 affixed to the
base member 129,
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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.
102211 Referring back to FIG. 7A, 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.
102221 In an alternate embodiment, as shown in Ms, 26 and 27, instead of
horizontally
extending syringe gripping arms with two-dimensional horizontal and vertical
motion of each
arm 110, 1.1.1, 112, vertically extending syringe gripping antis are
implemented with vertical and
rotational motion of each arm 110, 111, 112. This is made possible by
replacing the laterally--
extended fork-shaped fingers each with standard 'N" shaped openings with one
or more right-
angle plates each having a transverse curvilinear notch or "curvilinear jaw.'
This way, each
syringe gripping arm 110, 111 and 112 terminates with at least. one
horizontally-oriented
curvilinear jaw, wherein the notch -forms an overall curved shape along the
horizontal plane of
the gripping arms 110, 111 and 112 Which lessens in width towards its closed
end. The
advantage of this configuration is that the syringe gripping arms 110, 111,
112 extend vertically
from the horizontal base member of the filling station and may enter the
filling station through
fluid-sealed bushings, whereas the above-described two-dimensional embodiment
requires
elongate slots to permit vertical movement of the arms, but which are
difficult to seal to prevent
liquid medication and other materials from infiltrating into the interior of
the filling station.
Where the filling station is expected to operate in a clean-room environment,
the ability to
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environmentally seal the external filling area is an absolute requirement, and
the use of
vertical/rotational syringe gripping arms 110, 111, 112 rotating within sealed
rotary bushings
makes this possible. Additionally, in this embodiment, the sealed interface
between. the vertical
rotating mounting elements for arms 110, 111, 112 and 128 and the base plate
of the fining
station prevents any liquids or other materials spilled during the filling
process or otherwise from
leaking into the interior of the filling station. In this embodiment, arms
110, 111 and 112 may be
mounted through a horizontal base member of the filling station, extending
through rotary shaft
seals, and attached to linear and rotational servo motors mounted underneath
the filling station
base that control the motion of the arms 110, 111, 112 (as well as plunger
lifting arm 12.8) as will
be described. The servo motors thus control vertical position and axial
rotation of the vertical
mounting elements and therefore the anns 11.0, 111, 112 and 128 mounted
thereon, with plunger
lifting arm requiring only the capacity to raise and lower vertically, and not
to rotate. Thus, as
vertical mounting elements and arms 110, 111 and 112 rotate, they dose on the
various portions
of syringe S corresponding to their vertical orientation. Anus 110, 111 and
112 may rotate a.s far
as possible to grasp syringe S until the curvilinear gap between the fingers
matches the width of
the portion of syringe S upon which it doses; thus. arms 110, 111 and 112 will
rotate under
control of the servo motors until syringe S is snugly positioned within the
gap between the
fingers. In addition, upper and middle arms 110 and. 111 may rest. on the same
vertical mounting
element spaced vertically from. one another, with a clamping cylinder
incorporated there between
to control their relative vertical orientation. Clamping cylinder may pull
upper arm 110 down on
top of middle arm 111 to sandwich the syringe hilt or flange between them as
described.
Advantageously, the use of a low cost clamping cylinder eliminates a more
costly servo motor to
independently operate arm 1.10 and/or 111 , In all other respects, arms 110, 1
1 1, 112 and 128
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may perform the same functions as described herein.
102231 Prior to filling, the scanner 121 at the syringe filling station 5
reads the machine readable
label cm the bottom surface of the container 104 to again verify that the
selected container
contains the correct medicine.
(02241 Once verified to be the correct, the tipper arm 110 lowers to contact
the upper surface of
the syringe S finger flange, and the middle arm 111 raises to contact the
lower surface of the
syringe S linger flange. Initially, plunger lifting arm .128 pushes the
syringe piston all the way
up and the lower arm 112 lowers to clamp the syringe piston downward against
the plunger
lifting arm 128. Priming of the syringe S takes place as lower arm 112 and
plunger lifting arm
128 move up and down in concert with each other to perform the syringe priming
sequence.
After priming is complete and with the syringe piston fully retracted, the
syringe can be filled.
102251 During fill operations the upper, middle and lower arms 110, 111 and
112 are initially in
a horizontally retracted state. The lower MTh 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, and the syringe S is entirely evacuated by fully depressing the
plunger within the
barrel If the syringe. S is entirely evacuated (le. 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
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insertion into the container/syringe interface by relative movement of the
upper, middle, lower
and lifting arms 110, Ill, 112 and 128. Upon insertion of the tip in the
container/syringe
interface the plunger is first fully depressed by the lift ann 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.
102261 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 containerfsyringe
interface 210, 212,
214, 216 and where an elastomeric insert 225 is present it 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 is withdrawn to draw in any
medicine left in the
elastomeric insert 225 so as to avoid drippage..
(0227j With reference to FiCis, 40-43, where a push-pull cap 224 is used as
the syringe,
medication container interface to enable the medication container to interface
with a Luer lock
oral syringe, syringe filling station 5 additionally comprises a grooved block
400 for actuating
slide disc 91 to open and close push-pull cap 224 between each syringe fill.
As shown in FIG.
43 (at A), grooved block 400 comprises a horizontal block having a cutout
through the entire
height thereof to accommodate the exterior diameter of push-pull cap 224 above
and below slide
disc 91. At a height-wise midpoint of the inner wall of the cutout is a groove
corresponding to
the outer diameter of slide disc 91 such that slide disc may be captured
within the groove when
the medication container is properly positioned in yoke 82. Grooved block 400
is positioned a
given distance below yoke 82 such that it captures slide disc 91 within its
groove when push-pull
cap 224 is in a closed position (with slide disc 91 raised and tab 86 in upper
groove 87a; see FM.
29 at B) and is movable vertically relative to stationary yoke 82,
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102281 In a first embodiment, shown in FIG. 41, grooved block 400 is
operatively connected to a
horizontal air cylinder 401 via two cams 404 comprising cam slots 402. Air
cylinder 401 is in
turn connected to OSPS software for controlling the operation of air cylinder
401 based on one
or more programmed syringe filling sequences. When air cylinder 401 is
retracted, cams 404
move inward towards air cylinder 401 and awn from the syringe and medication
container.
Two cam followers 405 each have a horizontal arm, a portion of which is
disposed in one of the
two cam slots, and a vertical arm connected to the hOfiZOntai WM and extending
downward
through yoke 82 to connect to grooved block 400. Cam followers 405 are held
stationary within
the horizontal plane but movable within the vertical plane, such that when
cams 404 move
inward, cam followers 405 are pushed downward following the downward incline
of the cam
slots 402 in the direction opposite that in which cams 404 are moving. By
their attachment to
grooved Wel( 400, cam followers 405 in turn push grooved block 400 downward
which forces
the slide disc. 91 held within grooved block 400 downward, opening push-pull
cap 22+
Likewise, when air cylinder 401 is extended, cams 404 move outward away from
air cylinder
401, cam followers 405 are pulled upward following the upward incline of the
cam slots 402,
grooved block 400 is pulled upward and slide disc 91 is pulled upward, closing
push-pull cap
224. Syringe gripping arms 78 are also mounted to grooved block 400 such that
the syringe
body is pulled upward or downward in the same magnitude as slide disc 91 and
nozzle 90 of
puSh-pull. cap 224 such that a connection between the syringe S and nozzle 90
is constantly
maintained until push-pull cap 224 is closed and the syringe S is removed from
the filler. For
filling operations not involving a push-pull cap 224, grooved block can be
articulated out of the
way and air cylinder 401 will hold syringe gripping fingers 78 in a stationary
position relative to
yoke 82,
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102291 In a second embodiment, shown in FIG, 42, the operation of grooved
block 400 and its
interface with slide disc 91 and syringe gripping fingers 78 is the same as
described above.
However, horizontal air cylinder 401 is replaced by vertical air cylinder 403
which moves
grooved block 400 in a vertical direction directly without the need to utilize
cam slots 402.
102301 To enable the conversion between the use of tapered tip syringes (FIG.
38) and Liter lock
syringes (FIG, 39) as is expected in the future for safety reasons, the entire
system described
herein may be modular to allow replacement of those modules designed
specifically for tapered
tip syringes as the Liter Jock. syringe rollout takes place.
102311 FIG, I 6A illustrates an shaker mechanism 820, which may be either
integral to filling
station 5 or a standalone unit, in which a single-speed motor 823 operates
through an electronic
clutch 8.27 to rotate cam wheel 824. In a preferred embodiment, filling
station. S comprises a
base module containing syringe gripping fingers and a top module for
supporting the medication
container in an inverted .position for filling the syringe. The top module may
be shaker
mechanism 820, or may be a module comprising medication container yoke 82A,
828 and/or
self-centering jaws 82C and medication container platform 79 without any
integral shaking
mechanism, such as when a separate shaking mechanism 6 is used. Preferably,
either of these
top modules may be interchangeable based. on design preference to allow for,
i.e., an upgrade of
the system from comprising an independent shaker mechanism 6 to integral
shaking mechanism
820 or to allow the system to be adaptable to different needs. The top module
and base module
may be connected by a series of screws or any other non-permanent connection
means known in
the an.
102321 For shaking mechanism 820, an eccentric pin 829 protruding from cam
wheel 824
slidably engages a slotted block 830 as shown, and block 830 directly engages
plate 821, When
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the motor 823 is activated it reciprocates plate 821, again shaking it and
mixing the contents of
medicine container 104 held therein.
[02331 FIG. 163 is a composite operational diagram illustrating the operation
of the integral
shaking mechanism 820 of FIG. 16A external of the syringe filling station 5.
The plate 821
which supports the medicine container platform and syringe yoke is mounted on
vertical slides
831. A slotted driven block 832 mounted on the plate 821 is engaged by
eccentric pin 829. As
the pin 829 rotates within the slot of block 832 the block 832 oscillates up
and down_ A single
position clutch is mounted to the motor so that the slotted driven block as
well as the entire
platform stops at the same downward position all the time. The insets at top
illustrate eccentric
pin 829 engaging slotted driven plate 83.2 at top dead center (left), 90
degrees rotation, and
bottom dead center.
[02341 FIG. 17 is a perspective view of an alternative remote medication
container shake
station 6 (i.e. not an integral part of the filling station 5. as seen in FIG.
2) for shaking the
medicine container when required. The shake station 6 comprises a motor 62
with. an offset
trough 64 coupled to the rotary shaft 63. The trough 64 is an elongate arched
platform for
seating and centering medicine containers of various sizes. An upright post 65
abuts the base of
the medicine container and self-centers it, allowing tightening of restraining
straps 66. The
straps 66 secure the medicine container along an oblique offset. axis relative
to that of the shaft
63. This partieular configuration makes loading of the medicine container on
the trough 64 very
easy as seen in FIG. 17. When the motor 62 is activated the oblique rotation
of the medicine
container causes a centrifugal force that keeps the container against the stop
post 64.
Constrained by the bands 66 and post 65 the medicine container is effectively
and efficiently
shaken.
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102351 The (optional) semi-automated capping station 8 (see FIG. 2)
ticiiitates syringe cap
placement on the open tip of the filled syringe S. fed from an inclined
capping chute 149 (see
FIG. 10). Referring back, FIG. 10 is an enlarged perspective view of the semi-
automated
capping station 8 with .feeder bowl 147 and inclined capping chute 149. Feeder
bowl 147 may be
a centrifugal or vibratory bowl feeder as known in the art, sized for sorting
and feeding syringe S
caps single-file down inclined chute 149. A transparent plastic chute cover
145 may be provided
overtop chute 149 to prevent access to all but the leading syringe S cap. It
is rather common for
pharmacy technicians to improperly cap filled syringes prior to
administration, and this leads to
leaking, contamination and other problems. A mechanism is herein provided to
prevent this.
When the leading syringe caps reach the bottom of chute 149 they come to bear
against a
cylinder rod 146 in a position, directly overhead an electronic pressure
transducer 148. Pressure
transducer 148 is in communication with the OSPS central controller and
registers the pressure
of the syringe S nozzle pressing against transducer 148. A threshold pressure
indicator LED 144
is mounted proximate transducer 148: To cap a syringe $ the operator merely
presses it down.
onto the leading cap until an acceptable threshold pressure is attained, and
this is signaled by an
LED indicator 144. At this point the cylinder rod 146 retracts allowing the
operator to pull the
capped syringe S out and fret. The OSPS central controller preferably logs
this in its track and
trace database to provide an audit trail. This mechanism avoids any issues
with improperly
capped syringes.
102361 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 medicine Storage
facility 2 by the operator, who may retrieve another medicine, and replace it
in the syringe filling
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station 5 for the next medicine to be dispensed.
[02371 In a preferred embodiment, a 21) barcode on. the syringe, medication
container or cap
may be scanned at each station described herein, and red/green lights or
another visual or audible
alert may indicate to the operator and/or to the software that a required
protocol has not been
followed for a given syringe, medication, or the like. For instance, a red
light may be used to
indicate: when a medication container is scanned at filling station 5, that
the medication has
expired, or to indicate, at the visual inspection station 9, that syringe S
has not been filled to the
proper fill volume as required for a given prescription. Scanning a 21)
barcode at each station
described herein would also permit the pharmacist or other operator to process
medication or
syringe/cap/container recalls more promptly and prevent any recalled items or
medication from
being provided to a patient Recall infomunion. may be entered directly into
the OSPS system.
when received by The hospital or pharmacy and the software may check every
scanned item
against the database of recalled medicationsandfor devices.
102381 The 213 barcode described herein is preferably generated for syringe S
at the syringe
labeling station, and for the medication container at the Medication container
Orientation and
Login Station CHG. 2 (1)). Thus, in a preferred embodiment, the 21) barcode on
the medication
container is scanned at the Medication Container Orientation and Login Station
(after it is
generated) and the filling station 5, and the 213 barcode on the syringe S is
scanned at the syringe
labeling station (after it is generated), the filling station 5, syringe
capping station 8, filled
syringe inspection station 9, and bagging station 7.
[0239.1 Referring back to FIG. 2, after retrieval from the syringe filling
station 5 and capping at
syringe capping station 8, the operator places the syringe on inspection
system 9 to cross check.
the weight. and/or volume of the filled syringe against the expected
weight/volume. The tare
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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
(described above) 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 9 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
102401 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.
[02411 With reference to FIG& .1.1 and 12, 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. and local digital inputs and outputs. The main controller
300 is 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 tbr
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 fonnatted to discern
and populate order
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information based on a user specified data stream and structure.
[02421 Sub-controllers are provided for all downstream machine sections such
as Syringe
Storage 320, litspectoritabelerNerifier 330, and Medicine. Library 350. The
sub-controllers are
each provided with a local inputloutput system and local motion controller
integrated with the
main controller 300 via the communications backbone 310. The main container
orchestrates the
integration and operation of the downstream machine elements as described
above and controls
the overall operational mode of the system 100.
[02431 The local OSPS Computer may incorporate fin weight/volume adjustment
software.
Specifically, the vision inspection station 9 (FIG. 2) 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 fining station 5.
The software
determines if a syringe has too much or too little medicine in it. Any out
syringe will be
rejected and the system will automatically queue a replacement utilizing
information from the
previously-rejected syringe.
[02441 FIG, 13 is a perspective view of an exemplary cappingidecapping station
93, which
comprises an elevated plattbim support surface 952 for stabilizing the
medicine container. An
optional container clamp (not shown) may be mounted on the support surface 952
for centering
and constraining the medicine container. The container clamp may comprise a
pair of opposing
V-shaped clamps, An operator presses a 'clamp- button and the opposing V-
shaped clamps
close around the container bottle. The V-shaped clamps may be mounted on low-
friction slides
so that any size bottle can be slid toward the center of the chuck.. Although
the clamps are
mounted on low friction slides, they remain stationary to rotation. An
articulating spindle
assembly extends upward from a base 953 mounted on the support surface 952,
the spindle
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assembly including a vertical piston 954 extendable/retractable from base 953
and a horizontal
mast 955 extending from piston 954. The mast 955 contains a motor which drives
a vertical
spindle 959. A manual lowering artn 956 is geared to the piston 954 ism piston
extension/retraction from base 953, thereby allowing an operator to raise or
lower spindle 959
manually. A pressure sensor 957 is mounted to the spindle 959 (or internal to
the mast 955 for
sensing the downward pressure.. A chuck 958 is mounted at the lower end of the
spindle 959.
As seen in the inset (at. left), the chuck 958 is preferably fanned with a
hard outer shell (e.g.,
stainless steel) and a molded plastic core placed inside, the care defined by
a conical interior
surface with an elastomeric inner lining. An elastomer such as polyurethane or
equivalent resin
can be poured around the interior of the core to form the elastomeric lining.
A lateral slot enters
the interior of the chuck 958. This chuck 958 is designed to fit all paps
ranging from 18 mm to
38 mm in diameter. Due to its conical interior and elastotneric inner lining,
downward pressure
onto the container cap causes a non-slip, gripping action. The slot
accommodates certain
container caps which have a tethered closure feature. The tether is free to
protrude and will not
cause interference between the chuck 958 and cap. This cappingidecapping
station 93 enables
the medicine caps to be loosened from their containers mechanically without
the need for an
operator to exert strong hand pressure. The system is capable of loosening
caps as well as
applying torque to seat them. In operation, the medicine container is placed.
on the support
surface 952, and the operator centers the container either with the optional
holding clamp or by
hand, and if to cap a pre-labeled container/syringe interface is placed on the
container. Upon
moving the manual lowering arm 956 forward, the piston 954 extends from base
953, thereby a
lowering spindle 959. The chuck 958 descends into contact with the
container/syringe interface
to tighten it, or into contact with the manufacturer cap if decapping is
desired. Once the chuck
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958 descends onto the cap and downward force is applied the pressure sensor
957 begins to
compress and in doing so, signals the motor to start. This avoids inadvertent
rotation of the
elastometic chuck 958 in advance of contacting the cap which may cause
abrasion and emit
particles of the elastomer in the vicinity of the work area. The scanner 95A
may be mounted
beneath the platfo.mt support 952 to read the medicine container's 21) barcode
from beneath.
Preferably, the scanner 95A is synchronized via the OSPS computer such that
the first time it
reads a particular barcode the spindle 959/motor turn in the counter-clockwise
(cap removal)
direction. Conversely, the second time scanner 95A reads that particular
barcode the spindle
959/motor turn in the clockwise (cap tightening) direction. The assembled
medicine container
and container/syringe interface can be slid out and removed.
[0245] FIG. 14 is a perspective view of the label photographing station 98
resident at the
Medication Container Orientation and Log-in Station. The label photographing
station 98 is
employed for the purpose of photographing the entire medicine container's
label for archival
purposes (to retain a record of the medication used to till a specific
prescription). In some cases,
the .barcode scan from scanner 95A alone will be insufficient to identify
details such as medicine
concentration, expiration, handling and other precautions relative to the
medication. 'The label.
photographing station 98 comprises a circular table 984 rotatably seated atop
a support Surface
982. A camera 988 is oriented directly toward a focal point centrally atop the
table 984, and a
pair of opposing sensors 986a, 986b is indirectly aimed from the sides toward
that same focal
point. The camera 988 and sensors 986a, 986b are all mounted on a common
undercarriage via
struts that pass through tracks in the table 984. This allows the camera 988
and sensors 986a,
986b to translate in unison along the tracks in the table 984. The
undercarriage is servo-driven
(or otherwise adapted for controlled translation) under control on the OSPS
Computer, in
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accordance with feedback from sensors 986a, 986b. The medicine container may
be manually
placed anywhere atop the table 984, and the OSPS Computer will drive the
undercarriage until
the sensors 986a, 986b align with the surface of the medicine container. The
sensors 986a, 986b
track the An-111U of the container and travel with that focal surface, along
with the camera 988.
This positions the camera 988 at exactly the proper focal distance regardless
of container
position, and maintains the optimum focal distance from label to camera 988
despite a variety of
sizes and shapes of medicine containers.
Process And System Configuration Variations Specific To Container/Syringe
Interfaces
[02461 'Wing a Syringe Using A standard commercially avaliable -13a.xa" cap
214 (see FIG. 5)
[02471 The standard commercially available BaxiiIm cap 214 comprises a female
threaded cap to
fit over medication containers and is available in sizes to accommodate most
medication
containers. Baxarm cap .214 enables. an oral syringe to enter its center hole
and withdraw an
amount of liquid from the medication container while the medication container
is positioned
upside down, For the syringe to be removed from the medication, both syringe
and medication
container must be up-righled. Once up-righted, the syringe S can be removed
from the up-
righted medication bottle with no leakage. If the medication bottle requires
shaking at any given
time, it can be done manually or in a separate shaker (FIG. 17) by closing the
tethered cap and
fastening the bottle into the shaker tray. The sequence of operation is as
follows:
a. Remove original cap (FIG. .18A).
b. The Base.' cap 214 is applied onto the neck of the container (FIG. 188).
c. The syringe S is inserted into the Sam"' cap 214. (FIG. 18C).
d. The medication container and the syringe S combination are rotated up-side-
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down. (FIG. 181)).
e. Both the medication container and the inserted syringe S are then inverted
and
placed into the yoke 8.2A (FIG. 18E) of the filling station 5 (see Fig 7A).
I. The Syringe is clamped by the tiller finger grippers 78 and a platform 79
(FIG.
18F) lowers to the bottom of the over turned. medication bottle and applies
downward pressure to the bottle as it is supported by the yoke 82 (see FIG.
71)).
g. Now the syringe gripping arms 110, 1.11 and 112 engage the syringe S
plunger,
prime and pull the plunger to the exact fill dose (see Ha 7A).
h. Remove medication container and the syringe S combination and extract
syringe
S.
102481 Filling An Oral Syringe Using An OEM-Baxarm Cap With Self Sealing Valve
216 (see
FIG. 51
[02491 As described above the standard Baxani cap is modified to incorporate a
self-sealing
valve 216 which enables an oral syringe S to enter its center hole while the
medication container
is positioned upside down without leaking. The Baum Cap with Self Sealing
Valve 216 also
allows for syringes to be removed after filling without removing the
medication container from.
the filing station 5 (see FIG 2 III I) and repeat the filling of subsequent
syringes S when a quantity
of syringes are to be tilled with the same medication. In the event of a
scheduled Shaking
requirement, after a specified amount of time, the system can shake the
medication without
removing it from the filling station (see FIG. 16A). Frequency and strokes pet
minute are pre-
programmed into the system. The sequence of operation is as follows:
a. Remove original cap (FIG, 19A).
b. Baxam, Cap with Self Scaling Valve 216 is tightened onto the neck of the
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container (FIG. 1913).
c. Medication container is turned upside down (see FIG. I9C). The neck of the
container is placed into a slotted yoke 82B or the self-centering spring
loaded
jaws 82C (FIG. 7B). Since the neck of the container is held on center by the
slotted yoke 828, or the self-centering spring loaded jaws 82C the opening to
the
Baxa Cap with Self Sealing valve 216 will be properly aligned with the syringe
S
and the mechanism for filling the syringe S by pulling the syringe plunger
downward. (see FIG I 9C).
d. The medication container platform 79 is lowered to securely hold the
medication
container in place onto either the Yoke 82A (see FIG. 19C).
e. If the medication container needs to be shaken, it is shaken. at the
programmed
speed, duration and frequency (see FIG. 16A).
f. The syringe S tip is inserted up, into the Baxa Cap with Self Sealing Valve
opening 216.
g. The syringe S is filled by the syringe gripping, arms 1.10, 111 and 112
which
engage the syringe S plunger, prime and pull the plunger to the exact fill
dose (see
FIG, 191)).
h. The syringe is undamped by the filler finger grippers 78 and the syringe is
removed from the Medication container MO. 19D).
i. If additional syringes S need to be filled with the same medication, the
process is
repeated.
j. When all syringes have been filled with the medication, the platform 79
rises and
the medication bottle is removed.
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k. This process continues until all syringes for that prescription production
run have
been filled.
[02501 Filling A Swing Using A MBA (No Valve) 210 (see FIG. 51
[02511 If a medication container with valveless PIBA 210 requires shaking,
this must be done
either manually or with the optional live standing shaker (FIG. 17), This must
be repeated every.
time shaking is required regardless of whether the same medication is being
filled into multiple
syringes. The original cap must be placed over the Medication bottle and its
press-in insert,
during storage, to ensure cleanliness. The sequence of operation is as
follows;
a. Remove medicine bottle cap (FIG. 20A).
I . The valveless NBA 210 is inserted into the neck of the container
(FIG_ 20B).
c. The syringe S is inserted into the valveless NBA 210 (FIG; .20C).
d. The medication container and the syringe S combination are rotated up-side-
down. (FIG. 20D).
e. 'Fhe medication container and syringe S combination are placed into the
filling
station 5 via Yoke 8213 or Self-Centering jaws 82C (FIG. 20E).
f After filling., the medication container and syringe S combination are
removed
from the filling station 5.
g. The medication container and syringe S combination are then up-riOted (FIG;
20C), and the filled syringe is then removed from the medication container.
[02521 Filhin A Syringe S USitItT A P1BA (With Valve) 212/225 (see FIGsµ 5 and
441
[02531 The Self Sealing NBA Insert 21:2 is pressed into the neck opening of a
medication
container and enables an oral syringe S to enter its center hole and withdraw
an amount of liquid
from the medication container while the medication container is positioned
upside down. In
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addition, it also enables the syringe to be removed without leaking and the
medication container
to be shaken at the fill station 5 (FIG. 2 III), while it is positioned upside
down and without
leaking. The self sealing NBA insert 212 also allows for syringes S to be
removed after filling
without removing the medication bottle and repeat the filling of subsequent
syringes S in cases
where a quantity of syringes S are to be Filled with the same medication. In
the event of a
scheduled shaking requirement, after a specified amount of time, the system
can shake the
medication without removing it from the filling station (see FIG. 16A),
Frequency and strokes
per minute are pre-programmed into the system. The sequence of operation is as
follows:
a. Remove medicine bottle cap (FIG. 2IA).
b. The self sealing NBA insert 212 is inserted into the neck of the container
(FIG.
21B).
The medication container is turned upside down (FIG. 21C).
d. The neck of the container is placed into the Self Centering Jaws 82C or
Yoke 8213
(FIG. 211)) Since the neck of the container is held on center by the yoke.
8213 or
Self Centering Jaws 82C, the opening to the self sealing PIBA insert 212 will
be
properly aligned with the syringe S and the mechanism for filling the syringe.
e.. The medication container platform 79 is lowered to. securely hold the
medication
container in place on the Self Centering jaws 82C (see FIG, 2114
f If the medication container needs to he. shaken, it is shaken. at
the programmed
speed .duration and -frequency (see FIG. 16A) while still held in the filling
station
5.
g. The syringe S is inserted into the self sealing NBA insert 212 opening
(FIG.
21F.),
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K The syringe is filled.
i. The syringe is removed from the medication container.
J. If additional syringes need to be filled with the same medication,
the process is
repeated while the medication bottle remains held within the filler.
k. When all syringes S. have been filled with the medication, the medication
container is removed.
1. This process continues until all syringes for that prescription production
run have
been filled.
10254i Ftllina An Oral Svrinae Using A Valved Seif-Sealint, Two Piece Cap With
Common
Outer Diameter 220,221 (see FIG. 3
f025.5f As described above, the cap comprises a common Outer diameter portion
and either an.
insertable or integrally-formed self-sealing insert Which enables an oral
syringe S to enter its
center hole while the Medication container is positioned upside down without
leaking. The
valved self-sealing one or two-piece cap 220, 221 also allow syringes to be
removed after filling
without removing the medication container from the filing station 5 (see FIG 2
III) and repeat the
filling of subsequent syringes S when a quantity of syringes are to be filled
with the same
medication. In the event of a scheduled shaking requitement, after a specified
amount of time,
the system can shake the medication without removing it from the filling
station (see FIG. I 6A).
Frequency and strokes per minute are pre-programmed into the system. The
sequence of
Operation is as follows:
a. Remove original cap (FIG. 19A).
K Valved self-sealing one or two piece cap .220, 221 is tightened onto the
neck of
the container (FIG, 19.8).
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c. Medication container is turned upside down (see FIG. 19C). The neck of the
container is placed into a slotted yoke 828 or the self.centering spring
loaded
jaws 82C (FIG. 78). Since the neck of the container is held on center by the
slotted yoke 828, or the self-centering spring loaded jaws 82C the opening to
the
cap 220, 221 will be properly aligned with the syringe S and the mechanism for
tilling the syringe S by pulling the syringe plunger downward (see FIG, 19C).
d. The medication container platform 79 is lowered to securely hold the
medication
container in place onto either the Yoke 82A (see FIG. 19C).
e. If the medication container needs to be shaken, it is shaken at the
programmed
speed, duration and frequency (see FIG.. 164
f The syringe S tip is inserted up, into the cap opening :220. 221,
g. The syringe S is filled by the syringe gripping arms 110, 111 and .112
which, in
concert with arm 128, engage the syringe S plunger, prime and pull the plunger
to
the exact fill dose (See FIG, 19D).
h. The syringe is undamped by the Mier finger grippers 78 and the syringe is
removed from the Medication container (FIG. 191)).
i. If additional syringes S need to be filled with the same medication, the
process is
repeated,
j. When all syringes have been filled with the medication, the. platform 79
rises and
the medication bottle is removed.
lc This process continues until all syringes for that prescription production
run have
been filled.
l0256) Filling A Swine $ Using A Push-In Tip 223 For Interfacing With Lucr
lAck Oral
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swinees (see FICis 27-281
[0251 The push-in tip 223 is pressed into the nozzle opening of a Baxim or
Baxam-equivalent
manufacturer-supplied medication container cap (FIG. 27) or NBA cap (FIG. 28).
If a
medication container with push-in tip 223 requires shaking, this must be done
either manually or
with the optional free standing shaker (FIG, 17). This must be repeated every
time shaking is
required regardless of whether the same medication is being filled into
multiple syringes. A
protective cap 223C must he placed over the Meditation bottle during storage,
to ensure
cleanliness. The sequence of operation is as Ibllows:
a. The push-in tip 22.3 is inserted into the nozzle opening of a Base" or
Baxem-
equivalent manufacturer-supplied medication container cap (FIG. 27) or PIBA
cap (FIG. 28).
b. The syringe S is inserted into the push-in tip 223 (M. 27C and 28c).
c. The medication container and the syringe S combination are rotated up-side-
down.
d. The medication container and syringe S combination are placed into the
filling
station 5 via Yoke 82A, Yoke 828 or Self-Centering jaws 82C.
e. After filling, the medication container and .syringe S combination are
removed
from the filling station 5.
f The medication container and syringe S combination are then up-righted and
the
filled syringe is then removed from the medication container.
102581 Filling A Syringe S Using A Push-Pull Cap 224 For Use With A MBA or
BaxaTm or
Baxarm-equivalent Medication Container Cap And Luer Lock Oral Syringe (FIGs.
29-32)
102591 The push-pull cap 224 is inserted over the nozzle of a Baxarm or Baxam-
equivalent
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manufacturer-supplied medication container cap (110. 29) or into the nozzle of
a PIRA (FIG.
31). Alternately, push-pull cap 224 is made integral with either a Baxem or
Baxem-equivalent
manufacturer-supplied medication container cap (FIG. 30) or a PIRA (FIG. 32)
enabling the
integral cap to be screwed directly onto or pushed directly into the neck
opening of a medication
container, respectively. AU of these arrangements enable an oral syringe S to
enter the center
hole of cap 224 and withdraw an amount of liquid from the medication container
while the
medication container is positioned upside down. In addition, they also enables
the syringe to be
removed without leaking and the medication container to be shaken at the fill
station 5, while it
is positioned upside down and without leaking. The push-pull cap 224 also
allows for syringes S
to be removed after filling without removing the medication bottle and repeat
the filling of
subsequent syringes S in cases where a quantity of syringes S are to be filled
with the same
medication. In the event of a scheduled shaking requirement, after a specified
amount of time,
the system can shake the medication without removing it from the filling
station (See FIG. 16A).
Frequency and strokes per minute are pre-programmed into the system. The
sequence of
operation is as follows:
a. For integral push-pull caps 224, remove medicine bottle cap; for separable
push-
pull caps 224, insert push-pull cap 224 directly over or into a Baxirm or
Baxa'04-
equivalent manufacturer-supplied medication container cap, respectively.
b. The medication container is turned, upside down.
c. The neck of the container is placed into the filling station.
d. The medication container platform 79 is lowered to securely hold the
medication
container in place at the filling station 5.
e. If the medication container needs to be shaken, it is shaken at the
programmed
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speed, duration and frequency (see FIG. IA) while still held in the filling
station
5.
f The syringe S is inserted into the nozzle 90 of push-pull cap 224.
g. The syringe is filled.
Ii. The syringe is removed from the medication container.
i. if additional syringes need to be filled with the same medication, the
process is
repeated while the medication bottle remains held within the filler.
3. When all syringes S have been filled with the medication, the medication
container is removed.
k. This process continues until all syringes for that prescription production
run have
been filled.
[02601 In the future, for drug and-countertaing purposes, medication
containers may include
2D barcode,s applied to them by the manufacturers with unique ID numbers and
other data.
Consequently, medication containers may be supplied to the pharmacies with a
pre-applied 21)
barcode providing a unique ID number and other medication-related data. When
this is the case,
the system does not require that a special barcode label with information on
the medication be
generated and attached to the base of the medicine container. The medication
Container Login &
Orientation Station I may be bypassed and/or omitted entirely, and the
manufacturer's barcode
on the container is utilized. A track, trace and control system is similar to
the 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, The system minimizes downtime as well as processing time
to take and fill
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orders, and is easy to clean and capable of maintaining an environment free
from cross
contamination. The stem 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 a syringe
filling device only to a
semi-automated combination of labeling, filling, inspection, capping, andlor
bagging
functionality) based on the need of the individual institution.
102611 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 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 mans 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.
102621 In all the above-described embodiments, the entire system. is modular
and permits an
upgradeabie core based on the need of the individual institution. Optional
system components
such as the label photographing station 98 resident at die Medication
Container Orientation and
Log-In Station may be purchase and added to the system subsequent to the
original purchase.
[02631 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
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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.
STATEMENT OF INDUSTRIAL APPLICABILITY
102641 In hospitals around the world, many types of liquid medications are
necessarily
administered orally to patients who cannot or are unwilling to receive the
same medications by
injection. Thus, for a typical hospital, it may be necessary to fill hundreds
or thousands of oral
prescriptions each year by removing the prescribed amount of liquid medication
from a bulk
liquid medication container and placing it into an oral syringe in a clean
environment. Filling an.
oral syringe, prescription incorrectly, by placing the wrong medication, the
wrong dosage, by
mislabeling the syringe such that it is received by the wrong patient, etc.,
can be harmful or even
fatal to the patient who receives the medication (and to the patient who does
not receive the
proper medication). In addition, it is often necessary to rapidly fill
prescriptions for oral syringes
to promptly treat patients needing the liquid medication. A system for quickly
and accurately
filling several oral syringes in a hospital -setting would greatly increase
patient Safety and
treatment quality.. The present invention is a system and methods for the semi-
automated idling,.
bagging, and labeling of several and syringe prescriptions, wherein each step
in the filling,
bagging and labeling procedure, is performed at least in part by, and
monitored and tracked by, a
device controlled by a programmable controller which may interface with a
hospital prescription
database to further eliminate errors in filling oral syringes.
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