WO2004050038A2

WO2004050038A2 - Automated syringe preparation and automated transfer of medication thereto and safety features associated therewith

Info

Publication number: WO2004050038A2
Application number: PCT/US2003/038581
Authority: WO
Inventors: Joel A. Osborne; Dennis Tribble; Jose Raul Gonzalez
Original assignee: Forhealth Technologies, Inc.
Priority date: 2002-12-03
Filing date: 2003-12-03
Publication date: 2004-06-17
Also published as: AU2003297653A1; AU2003297653A8; WO2004050038A3; EP1578379A4; CA2505093A1; EP1578379A2; WO2004050038A8

Abstract

In one exemplary embodiment, an automated medication preparation system including automated syringe preparation that involves reconstitution of the medication is provided. The system includes: (1) a first automated gripping means for removing a tip cap from a barrel of one syringe and placing the removed tip cap at a first location; (2) an automated device for delivering a prescribed dosage amount of medication to the syringe by delivering the medication through the uncapped barrel in a just-in-time for use manner; (3) a controller in communication with the automated device and including a database for storing reconstitution information that is executable with the automated device for reconstituting the medication prior to it being injected into the syringe, wherein the reconstitution information include at least a concentration of the resultant medication and a mixing time for agitating the medication; and (4) a second automated gripping means for replacing the removed tip cap on the syringe barrel after the medication is injected therein.

Description

AUTOMATED SYRINGE PREPARATION AND AUTOMATED TRANSFER

OF MEDICATION THERETO AND SAFETY FEATURES ASSOCIATED

THEREWITH

Cross-Reference to Related Application

This application claims the benefit of U.S. patent application serial

No. 60/430,481, filed December 3, 2002, and U.S. patent application serial No.

60/470,328, filed May 13, 2003; U.S. patent application serial No. 10/426,910,

filed April 30, 2003; and U.S. patent application serial No. 10/10/457,898, filed

June 5, 2003, each of which is hereby incorporated by reference in its entirety.

Technical Field

The present invention relates generally to medical and pharmaceutical

equipment, and more particularly, to an automated apparatus for reconstituting and

later delivering a prescribed unit dose of medication to an automated syringe

preparation system.

Background

Disposable syringes are in widespread use for a number of different types of applications. For example, syringes are used not only to withdraw a fluid (e.g., blood) from a patient but also to administer a medication to a patient. In the

latter, a cap or the like is removed from the syringe and a unit dose of the

medication is carefully measured and then injected or otherwise disposed within the

syringe.

As technology advances, more and more sophisticated, automated

systems are being developed for preparing and delivering medications by integrating

a number of different stations, with one or more specific tasks being performed at

each station. For example, one type of exemplary automated system operates as a

syringe filling apparatus that receives user inputted information, such as the type of

medication, the volume of the medication and any mixing instructions, etc. The

system then uses this inputted information to disperse the correct medication into the

syringe up to the inputted volume.

In some instances, the medication that is to be delivered to the patient

includes more than one pharmaceutical substance. For example, the medication can

be a mixture of several components, such as several pharmaceutical substances.

By automating the medication preparation process, increased production and efficiency are achieved. This results in reduced production costs and

also permits the system to operate over any time period of a given day with only

limited operator intervention for manual inspection to ensure proper operation is

being achieved. Such a system finds particular utility in settings, such as large

hospitals, including a large number of doses of medications that must be prepared

daily. Traditionally, these doses have been prepared manually in what is an

exacting but tedious responsibility for a highly skilled staff. In order to be valuable,

automated systems must maintain the exacting standards set by medical regulatory organizations, while at the same time simplifying the overall process and reducing

the time necessary for preparing the medications.

Because syringes are used often as the carrier means for transporting

and delivering the medication to the patient, it is advantageous for these automated

systems to be tailored to accept syringes. However, the previous methods of

dispersing the medication from the vial and into the syringe were very time

consuming and labor intensive. More specifically, medications and the like are

typically stored in a vial that is sealed with a safety cap or the like. In conventional

medication preparation, a trained person retrieves the correct vial from a storage

cabinet or the like, confirms the contents and then removes the safety cap manually.

This is typically done by simply popping the safety cap off with one's hands. Once

the safety cap is removed, the trained person inspects the integrity of the membrane

and cleans the membrane. An instrument, e.g., a needle, is then used to pierce the

membrane and withdraw the medication contained in the vial. The withdrawn

medication is then placed into a syringe to permit subsequent administration of the

medication from the syringe.

Fig. 1 illustrates an exemplary conventional syringe 10 that includes a

barrel 20 having an elongated body 22 that defines a chamber 30 that receives and

holds a medication that is disposed at a later time. The barrel 20 has an open

proximal end 24 with a flange 25 being formed thereat and it also includes an

opposing distal end 26 that has a barrel tip 28 that has a passageway 29 formed

therethrough. One end of the passageway 29 opens into the chamber 30 to provide

communication between the barrel tip 28 and the chamber 30 and the opposing end of the passageway 29 is open to permit the medication to be dispensed through a

cannula (not shown) or the like that is later coupled to the barrel tip 28.

An outer surface of the barrel tip or luer 28 can include features to

permit fastening with a cap or other type of enclosing member. For example, the

luer can have threads 27 that permit a tip cap 40 to be securely and removably

coupled to the barrel tip 28. The tip cap 40 thus has complementary fastening

features that permit it to be securely coupled to the barrel tip or luer 28. The tip

cap 40 is constructed so that it closes off the passageway 29 to permit the syringe 10

to be stored and/or transported with a predetermined amount of medication disposed

within the chamber 30. As previously mentioned, the term "medication" refers to a

medicinal preparation for administration to a patient and most often, the medication

is contained within the chamber 30 in a liquid state even though the medication

initially may have been in a solid state, which was processed into a liquid state.

The syringe 10 further includes a plunger 50 that is removably and

adjustably disposed within the barrel 20. More specifically, the plunger 50 is also

an elongated member that has a proximal end 52 that terminates in a flange 54 to permit a user to easily grip and manipulate the plunger 50 within the barrel 20.

Preferably, the plunger flange 54 is slightly smaller than the barrel flange 25 so that

the user can place several fingers around, against, or near the barrel flange 25 to

hold the barrel 20 and then use fingers of the other hand to withdraw or push the

plunger 50 forward within the barrel 20. An opposite distal end 56 of the plunger

50 terminates in a stopper 59 or the like that seals against the inner surface of the

barrel 20 within the chamber 30. The plunger 50 can draw a fluid (e.g., air or a

liquid) into the chamber 30 by withdrawing the plunger 50 from an initial position where the stopper 59 is near or at the barrel tip or luer 28 to a position where the

stopper 59 is near the proximal end 24 of the barrel 20. Conversely, the plunger 50

can be used to expel or dispense medication by first withdrawing the plunger 50 to a

predetermined location, filling the chamber 30 with medication and then applying

force against the flange 54 so as to move the plunger 50 forward within the chamber

30, resulting in a decrease in the volume of the chamber 30 and therefore causing

the medication to be forced into and out of the barrel tip or luer 28.

Typically, a drug is provided of the shelf in solid form within an

injectable drug vial that is initially stored in a drug cabinet or the like. To prepare

an injectable unit dose of medication, a prescribed amount of diluent (water or some

other liquid) is added to the vial to cause the solid drug to go completely into

solution. Mixing and agitation of the vial contents is usually required. This can be a time consuming and labor intensive operation since first it must be determined

how much diluent to add to achieve the desired concentration of medication and then

this precise amount needs to be added and then the vial contents need to be mixed

for a predetermined time period to ensure that all of the solid goes into solution.

Thus, there is room for human error in that the incorrect amount of diluent may be

added, thereby producing medication that has a concentration that is higher or lower

than it should be. This can potentially place the patient at risk and furthermore, the

reconstitution process can be very labor intensive since it can entail preparing a considerable number of medication syringes that all can have different medication

formulations. This also can lead to confusion and possibly human error.

If the medication needs to be reconstituted, the medication initially

comes in a solid form and is contained in an injectable drug vial and then the proper amount of diluent is added and the vial is agitated to ensure that all of the solid goes

into solution, thereby providing a medication having the desired concentration. The

drug vial is typically stored in a drug cabinet or the like and is then delivered to

other stations where it is processed to receive the diluent. When using automated

devices, it is imperative that the vial be placed in its proper orientation at any given station since the processing of a vial that is not correctly orientated can lead to

serious damage or the apparatus and the vial and the contents of the vial

(medication) are likely lost. For example, during reconstitution and also during

withdrawal of the medication from the vial, a needle or the like pierces through a

septum of the vial to permit either a diluent to be injected therein or to permit the

medication to be withdrawn from the vial. If the vial is orientated upside down,

then the needle will strike the rigid bottom of the vial and this will lead to serious

damage or destruction of the needle as well as the vial being potentially displaced

and destroyed due to this striking action. During other processing operations, it is

important for the vial to be correctly orientated in order to ensure that the overall

operation runs smoothly and that no of the medication is wasted and that the costly

equipment is not damaged.

As is known, the safety of the patient is of utmost importance and

therefore, the various medication processing and manufacturing equipment typically

incorporate various safety features that indicate to a user (patient) whether the

product may have been tampered with at an earlier time. For example, a container

that houses solid medication, such as pills, tablets, or capsules, often includes a tamper proof label that extends and is sealed across the top opening of the container

underneath the cap. Thus, when a consumer initially purchases the product and unscrews the cap, the tamper proof label should be fully intact and sealed across the

opening of the container. If the label is not intact, the consumer should not use the

medication contained therein and instead should report the incident and discard the

bottle and its contents. Other types of tamper evident sealing are also know for

indicating to the consumer or patient whether the product may have been tampered with and therefore, should not be used for the sake of safety.

What is needed in the art and has heretofore not been available is a

system and method for automating the medication preparation process and more

specifically, an automated apparatus for reconstituting and then delivering a

prescribed amount of medication to a syringe or the like and one which overcomes

the foregoing problems.

SUMMARY

In one exemplary embodiment, an automated medication preparation

system including automated syringe preparation that involves reconstitution of the

medication is provided. The system includes: (1) a first automated gripping means

for removing a tip cap from a barrel of one syringe and placing the removed tip cap

at a first location; (2) an automated device for delivering a prescribed dosage amount of medication to the syringe by delivering the medication through the

uncapped barrel in a just-in-time for use manner; (3) a controller in communication

with the automated device and including a database for storing reconstitution

information that is executable with the automated device for reconstituting the

medication prior to it being injected into the syringe, wherein the reconstitution

information include at least a concentration of the resultant medication and a mixing time for agitating the medication; and (4) a second automated gripping means for

replacing the removed tip cap on the syringe barrel after the medication is injected therein.

One exemplary automated device for delivering a prescribed dosage

amount of medication to the syringe is an automated robotic device that is driven in

response to signals received from the controller and includes a cannula unit that is

rotatably mounted to a vertical base which is itself rotatably mounted to a lower ground base. The cannula unit includes a cannula extending thereaway for

performing at least one of the following operations: (1) receiving and discharging

diluent from a diluent supply in a prescribed amount to reconstitute the medication

in a vial; and (2) aspirating and later discharging reconstituted medication from the

vial into the syringe.

In another aspect, an automated medication preparation system

including automated syringe preparation is provided and includes: (1) an automated

injectable drug vial delivery assembly that identifies and transfers one drug vial

from a storage location to a fluid transfer station by means of a robotic vial gripper

device; (2) an automated device disposed at the fluid transfer station for delivering a prescribed dosage amount of medication to an uncapped syringe by delivering the

medication through the uncapped barrel in a just-in-time for use manner; and (3) a

multi-use medication station where drug vials that are identified as multi-use

medication vials are stored after the prescribed dosage amount of the medication is

withdrawn from the vial and an unused amount remains therein, wherein the vial is delivered to the multi-use medication station by means of the robotic vial gripper device and is available for later use when another syringe requiring the medication

contained in the vial is prepared.

In yet another aspect, an automated means for storing, dispensing and

orienting injectable drug vials for a robotic application is provided and includes a

plurality of automated syringe preparation stations is provided. The drug vial stores

the medication that is either is either in solid form and thus needs to be reconstituted

into the injectable drug or the vial can contain medication that was already been

previously reconstituted and is ready for delivery to the syringe. The automated

means includes a robotic vial gripper device for holding and transferring one vial

from one station to a next station of the robotic application; and a detector that

determines whether the vial is in a correct orientation throughout one or more

stations of the robotic application.

In one embodiment, the robotic application is an automated

medication preparation system that includes automated syringe preparation including

reconstitution of the medication and delivery of the reconstituted medication to the

syringe. The detector is configured to determine whether the vial is an upright position or is in an opposite downright position relative to ground. One exemplary

type of detector is used in combination with a vial that includes a magnetic chip

attached thereto at one end and the detector is capable of detecting a change in a

surrounding magnetic field such that when the vial is in a correct orientation, the

magnetic chip of the vial influences the detector and causes it to generate a control

signal indicating that the vial is in the correct orientation and can be advanced to a next station. If the vial is determined to not be in its proper orientation, the vial can

simply be discarded. In yet another embodiment, the vial has an optical marker and is used

in combination with an optical detector that is capable of detecting the optical

marker such that when the vial is in a correct orientation, the detector reads the

optical marker of the vial and generates a control signal that indicates that the vial is

in the correct orientation and can be advanced to a next station. Yet another suitable

detector is one which acts as a reader and scans and reads a scannable tag (bar code)

that is attached to the vial.

In yet another aspect, an automated medication preparation system

including a plurality of automated syringe preparation stations is provided and

includes (1) a first automated gripper for removing a tip cap from a barrel of one

syringe and placing the removed tip cap at a first location; (2) an automated device

having a positionable cannula that is operatively connected to an aspirating device

for drawing a prescribed dosage amount of medication from a supply and delivering

the dosage to the syringe by injecting the medication through the cannula and into

uncapped barrel in a just-in-time for use manner; (3) a second automated gripper for

replacing the removed tip cap on the syringe barrel after the medication is injected

therein; and (4) a tamper evident processing station that includes an instrument for

joining the tip cap to the syringe barrel in a localized area (e.g., spot weld or tamper

evident tape) so as to restrict the twisting and removal of the tip cap, thereby

providing evidence that the contents of the syringe are intact as filled (tamper

evidence).

In one exemplary embodiment, the tamper evident processing station is a heat-staking station and the instrument is in the form of a heated wire, rod, or

probe that is placed into contact with or in close proximity to the tip cap to cause the tip cap to join the syringe barrel in the local area. In other words, a local spot weld

is formed between the tip cap and the syringe barrel. In one embodiment and

depending upon the shape of the instrument, the bond is in the form of a

substantially circular spot weld. As the user removes the tip cap from the syringe

prior to use, the user will feel noticeable resistance to cap movement and will hear a

pronounced "snap" when the tip cap is twisted from the syringe. This resistance

and "snap" signals that the syringe contents are intact and have not been tampered

with nor has the tip cap has been inadvertently removed and replaced after the

syringe was prepared. Moreover, a laser can be used at the tamper evident processing

station to emit a laser beam which is directed to the tip cap to cause the melting and

bonding of the tip cap to the syringe barrel in a local area, thereby forming a spot

weld.

In yet another embodiment, the tamper evident processing station

includes an ultrasonic welder and the instrument is used to join the tip cap to the syringe barrel through pressure and high frequency mechanical vibrations, creating

localized frictional heat that melts the tip cap and the syringe barrel, both of which

are formed of a plastic material. When the vibrations stop, the plastic quickly cools

and solidifies, thereby forming the spot weld. Further aspects and features of the exemplary automated safety cap

removal mechanism disclosed herein can be appreciated from the appended Figures

and accompanying written description. BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a perspective view of a conventional syringe having a safety

tip cap removed therefrom;

Fig. 2 is a diagrammatic plan view of an automated system for

preparing a medication to be administered to a patient;

Fig. 3 is a local perspective view of an automated device for

removing the safety tip cap from the syringe;

Fig. 4 is a sectional elevation view of the automated device of Fig. 3

engaging the safety syringe tip cap;

Fig. 5 is a sectional elevation view of the automated device of Fig. 3

showing removal and placement of the safety tip cap on a post of a rotary device;

Fig. 6 is a local perspective view of a device for extending a plunger

of the syringe;

Fig. 7 is a sectional elevation view of the device of Fig. 6 prior to

engaging the plunger;

Fig. 8 is a sectional elevation view of the device of Fig. 6 showing

extension of the plunger;

Fig. 9 is a local perspective view of fluid transfer and vial

preparation equipment in a fluid transfer area of the automated system;

Fig. 10 is a side elevation view of a fluid pump system that that is located in the fluid transfer area shown in a first position for withdrawing diluent to

one syringe;

Fig. 11 is a side elevation view of the fluid pump system shown in a

second position for withdrawing diluent to another syringe; Fig. 12 is a side elevation view of the fluid pump system shown in a

third position for discharging diluent from one syringe;

Fig. 13 is a side elevation view of the fluid pump system shown in a

fourth position for discharging diluent from the other syringe;

Fig. 14 is a side elevation view of a fluid transfer device in a first

position where a cannula unit is in an extended position and the vial gripper device

moves the vial into a fluid transfer position;

Fig. 15 is a side elevation view of the fluid transfer device in a

second position in which the cannula is rectracted into the vial to permit transfer

either to or from the vial;

Fig. 16 is a side elevation view of the fluid transfer device in a third position in which the cannula unit and the vial gripper device are rotated to invert

the cannula within the vial and to permit aspiration of the contents of the vial;

Fig. 17 is a side elevation view of the fluid transfer device in a fourth

position in which the cannula unit and the vial gripper device are rotated back to the

original positions;

Fig. 18 is a side elevation view of the fluid transfer device in a fifth

position in which the cannula unit is extended so that the cannula, with the aspirated

medication, is removed from the vial;

Fig. 19 is a side elevation view of the fluid transfer device in a sixth

position in which the cannula unit is rotated to the rotary dial that contains the

nested syringes; Fig. 20 is a side elevation view of the fluid transfer device in a

seventh position in which the cannula unit is retracted so that the cannula thereof is

inserted into the syringe to permit the aspirated fluid to be delivered to the syringe;

Fig. 21 is a side elevation view of a fluid pump system according to

an alternate embodiment and that that is located in the fluid transfer area;

Fig. 22 is a side elevation view of an alternative arrangement where

stored medication is delivered through a conduit to a connector apparatus for

sealingly mating with an open tip cap of the syringe and wherein extension of the

syringe plunger causes a prescribed dose amount of medication to be drawn into the

syringe barrel;

Fig. 23 is a side elevation view of the connector apparatus sealed

with the syringe and the plunger being extended;

Fig. 24 is a local perspective view showing the mating between the

connector and the syringe;

Fig. 25 is a sectional elevation view of an automated device for

placing the safety tip cap back on the syringe with the device being shown engaging

the safety syringe tip cap disposed on the rotary device and removing it therefrom;

and

Fig. 26 is a sectional elevation view of the automated device of Fig.

25 showing placement of the safety tip cap back on the syringe;

Fig. 27 is an exploded perspective view of an automated device

according to another embodiment for removing, parking and replacing the syringe

safety tip cap;

Fig. 28 is a side elevation view of the automated device of Fig. 27; Fig. 29 is a front perspective view of an automated device for withdrawing a plunger of a syrmge;

Fig. 30 is a side elevation view of the automated device of Fig. 29;

Fig. 31 is an exploded perspective view of the automated device of

Fig. 29;

Fig. 32 is an exploded side elevation view of the automated device of

Fig. 29;

Fig. 33 is a local perspective of a first exemplary detector for

determining whether an injectable drug vial is in a correct orientation at a selected

station;

Fig. 34 is a local perspective of a second exemplary detector for

station;

Fig. 35 is a side elevation of one exemplary device for providing a tamper evident syringe;

Fig. 36 is a local elevation cut-away showing a local weld produced

using the device of Fig. 35;

Fig. 37 is side elevational view of a heat staking welding station

assembly with a welding tip according to a first embodiment;

Fig. 38 is a top plan view of the heat staking welding station

assembly with a rotary device holding a number of syringes;

Fig. 39 is a side elevation view of an exemplary tamper evident tape

sealing station; Fig. 40 is a top plan view of a section of the tape sealing station of

Fig. 39;

Fig. 41 is a side elevation view of the tape sealing device in a first operating position;

Fig. 42 is a side elevation view of the tape sealing device in a second

operating position;

Fig. 43 is a top plan view of a secondary tamper tape wiper;

Fig. 44 is a side elevation view of the wiper of Fig. 43 in an open condition;

Fig. 45 is a view of a syringe with tamper evident tape attached

thereto about the tip cap; and

Fig. 46 is a view of a syringe disposed into a sealed plastic bag.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Fig. 2 is a schematic diagram illustrating one exemplary automated

system, generally indicated at 100, for the preparation of a medication. The

automated system 100 is divided into a number of stations where a specific task is

performed based on the automated system 100 receiving user input instructions,

processing these instructions and then preparing unit doses of one or more

medications in accordance with the instructions. The automated system 100 includes a station 110 where medications and other substances used in the preparation process are stored. As used herein, the term "medication" refers to a

medicinal preparation for administration to a patient. Often, the medication is

initially stored as a solid, e.g., a powder, to which a diluent is added to form a medicinal composition. Thus, the station 110 functions as a storage unit for storing

one or medications, etc. under proper storage conditions. Typically, medications

and the like are stored in sealed containers, such as vials, that are labeled to clearly

indicate the contents of each vial.

A first station 120 is a syringe storage station that houses and stores a number of syringes. For example, up to 500 syringes or more can be disposed in

the first station 120 for storage and later use. The first station 120 can be in the

form of a bin or the like or any other type of structure than can hold a number of

syringes. In one exemplary embodiment, the syringes are provided as a bandolier

structure that permits the syringes to be fed into the other components of the system

100 using standard delivery techniques, such as a conveyor belt, etc.

The system 100 also includes a rotary apparatus 130 for advancing

the fed syringes from and to various stations of the system 100. A number of the stations are arranged circumferentially around the rotary apparatus 130 so that the

syringe is first loaded at the first station 120 and then rotated a predetermined

distance to a next station, etc. as the medication preparation process advances. At

each station, a different operation is performed with the end result being that a unit

dose of medication is disposed within the syringe that is then ready to be

administered.

One exemplary type of rotary apparatus 130 is a multiple station cam-

indexing dial that is adapted to perform material handling operations. The indexer

is configured to have multiple stations positioned thereabout with individual nests for each station position. One syringe is held within one nest using any number of

suitable techniques, including opposing spring-loaded fingers that act to clamp the syringe in its respective nest. The indexer permits the rotary apparatus 130 to be advanced at specific intervals.

At a second station 140, the syringes are loaded into one of the nests

of the rotary apparatus 130. One syringe is loaded into one nest of the rotary

apparatus 130 in which the syringe is securely held in place. The system 100

preferably includes additional mechanisms for preparing the syringe for use, such as

removing a tip cap and extending a plunger of the syringe at a third station 150. At

this point, the syringe is ready for use.

The system 100 also preferably includes a reading device (not shown)

that is capable of reading a label disposed on the sealed container containing the

medication. The label is read using any number of suitable reader/scanner devices, such as a bar code reader, etc. , so as to confirm that the proper medication has been

selected from the storage unit of the station 110. Multiple readers can be employed

in the system at various locations to confirm the accuracy of the entire process. Once the system 100 confirms that the sealed container that has been selected

contains the proper medication, the container is delivered to a fourth station 160

using an automated mechanism, such a robotic gripping device as will be described in greater detail. At the fourth station 160, the vial is prepared by removing the

safety cap from the sealed container and then cleaning the exposed end of the vial.

Preferably, the safety cap is removed on a deck of the automated system 100 having

a controlled environment. In this manner, the safety cap is removed just-in-time for

use.

The system 100 also preferably includes a fifth station (fluid transfer

station) 170 for injecting or delivering a diluent into the medication contained in the sealed container and then subsequently mixing the medication and the diluent to

form the medication composition that is to be disposed into the prepared syringe.

At this fluid transfer station, the prepared medication composition is withdrawn

from the container (i.e. , vial) and is then delivered into the syringe. For example, a

cannula can be inserted into the sealed vial and the medication composition then

aspirated into a cannula set. The cannula is then withdrawn from the vial and is

then rotated relative to the rotary apparatus 130 so that it is in line with (above,

below, etc.) the syringe. The unit dose of the medication composition is then

delivered to the syringe, as well as additional diluent if necessary or desired. The

tip cap is then placed back on the syringe at a sixth station 180. A seventh station

190 prints and station 195 applies a label to the syringe and a device, such as a

reader, can be used to verify that this label is placed in a correct location and the

printing thereon is readable. Also, the reader can confirm that the label properly

identifies the medication composition that is contained in the syringe. The syringe is then unloaded from the rotary apparatus 130 at an unloading station 200 and

delivered to a predetermined location, such as a new order bin, a conveyor, a

sorting device, or a reject bin. The delivery of the syringe can be accomplished

using a standard conveyor or other type of apparatus. If the syringe is provided as a

part of the previously-mentioned syringe bandolier, the bandolier is cut prior at a

station 198 located prior to the unloading station 200.

Figs. 3 through 20 illustrate parts of the third station 150 for

preparing a syringe, the fluid transfer station 170, and the sixth station 180 for preparing the syringe for later use. In other words, Figs. 3-15 illustrate in more

detail the stations and automated devices that are used in removal of the tip cap 40 from the barrel tip 28, the filling of barrel chamber 30 with medication and the

replacement of the tip cap 40 on the barrel tip 28. Fig. 3 is a perspective view of an

automated device 300 that removes the tip cap 40 from the barrel tip 28 as the

syringe 10 is prepared for receiving a prescribed dose of medication as part of the

third station 150 of the automated medication preparation system 100. The device

300 is a controllable device that is operatively connected to a control unit, such as a

computer, which drives the device 300 to specific locations at selected times. The control unit can be a personal computer that runs one or more programs to ensure

coordinated operation of all of the components of the system 100. The device 300

and other suitable devices described in greater detail in U.S. Serial No. 10/426,910,

which is hereby incorporated by reference in its entirety.

As previously mentioned, one exemplary rotary device 130 is a

multiple station cam-indexing dial that is adapted to perform material handling

operations. The dial 130 has an upper surface 132 and first and second retaining

members 134, 136 for securely holding one syringe 10 in a releasable manner.

More specifically, the first retaining member 134 locates the barrel 20 near the

distal end 24 thereof and the second retaining member 136 grips and holds the barrel

20 near the proximal end 22 thereof. One exemplary first retaining member 134

includes an arm 135 that is integral to the upper surface 132 of the rotary device 130

and extends outwardly from a main peripheral edge 137 of the dial. The arm 135

has a notch 139 formed at a distal end thereof that is complementary in shape and

size to the outer surface of the syringe 10 so that the syringe barrel 20 is received

and held within the notch 139. The notch 139 is defined by a pair of opposing fingers 141, with the notch 139 being formed therebetween. The notch 139 is thus

N-shaped in this exemplary embodiment.

The second retaining member 136 is configured to hold and retain the

proximal end 22 of the barrel 20. The second retaining member 136 includes operable pivotable arms 143, 145 that pivot between an open position where the

syringe 10 is free to be removed from the dial 130 and a closed position in which

the syringe 10 is securely held on the dial 130. A shaped surface 151 also forms a

part of the retaining member 136 and is disposed behind the pivotable arms 143,

145. The syringe 10 is disposed between the pivotable arms 143, 145 and the

surface 151 and in the retained position, the pivotable arms 143, 145 are in the

closed position and the syringe 10 is held securely between the pivotable arms 143,

145 and the surface 151. As will be described in greater detail hereinafter, the

controller directs the pivotable arms 143, 145 to either the open or closed positions.

A post 161 is provided for holding the tip cap 40 after its removal to

permit the chamber 30 to be filled with medication. One exemplary post 161 has a

circular cross-section and is formed near or at the interface between the arm 135

and the dial 130. The post 161 can also be formed on the upper surface 132 of the

dial 130. Thus, the precise location of the post 161 can vary so long as the post 161

is located where the tip cap 40 can sit without interfering with the operation of any

of the automated devices and also the post 161 should not be unnecessarily too far

away from the held syringe 10 since it is desired for the automated devices to travel a minimum distance during their operation to improve the overall efficiency of the

system 100. The specific shape of the post 161 can likewise vary so long as the post

161 can hold the tip cap 40 so that it remains on the post 161 during the rotation of the dial 130 as the associated syringe 10 is advanced from one station to another

station.

While in one exemplary embodiment, the syringes 10 are fed to the

rotary device 130 as part of a syringe bandolier (i.e., multiple syringes 10 are

disposed in series and interconnected by a web), it will be appreciated that the

syringes 10 can be fed to the rotary device 130 in any number of other ways. For example, the syringes 10 can be fed individually into the rotary device 130 from a

loose supply of syringes 10.

The automated device 300 is a robotic device and preferably, the automated device 300 is a linear actuator with a gripper. The device 300 has a

vertical base 310 which is adjustable in at least several directions. For example, the

vertical base 310 has an independent reach (y axis) and vertical axis (x axis) which

provides part of the flexibility and motion control that is desirable for the device

300. The vertical base 310 has an upper end 312 and an opposing lower end 314 which is operatively coupled to other movable components to permit the vertical

base 310 to move in an up/down direction along the x axis and in lateral directions

along the y axis. The upper end 312 is connected to a horizontal support member

320 that extends outwardly away from the vertical base 310. In one exemplary

embodiment, the lower end 314 is disposed between two support beams that are part

of a robotic device and are moved in a number of different directions, including

along the x axis and the y axis.

A block member 330 is connected to the horizontal support member

320 and more specifically, the block member 330 is disposed on an underside of the

horizontal support member 320 so that it is spaced away from the vertical base 310. The exemplary block member 330 has a block-like shape and is connected to the

underside of the horizontal support member 320 by one or more connectors that can

be in the form of support columns, etc.

The device 300 has first and second positionable gripping arms 340,

350 which are adjustable in at least one direction and which are coupled to and

extend downwardly from the block member 330. For example, each of the gripping

arms 340, 350 is movable at least in a direction along the y axis which provide the

flexibility and motion control that is desirable in the present system 100. The

gripping arms 340, 350 are programmed to work together in tandem so that both

arms 340, 350 are driven to the same location and the same time.

The block member 330 can house some of the electronic components and the like that permit the gripping arms 340, 350 to move between the open and

closed positions. The coupling between the block member 330 and the gripping

arms 340, 350 is such that the gripping arms 340, 350 have the necessary degree of

movement to permit the opening and closing thereof.

Each of the gripping arms 340, 350 is a generally L-shaped member

that is formed of a vertical section 342 and a horizontal gripping section 344 that

extends outwardly from one end of the vertical section 342. The gripping section 344 has a cut-out or notch 360 formed therein for receiving and gripping a section

of the tip cap 40 of the syringe 10. Accordingly, the notch 360 has a complementary shape as the shape of the tip cap 40. One exemplary notch 360 has

a generally semi-circular shape and it seats against approximately Vi of the outer

circumferential surface of the tip cap 40. By being movable along at least the y

axis, the gripping arms 340, 350 can be positioned between an open position in which the opposing gripping sections 344 of the arms 340, 350 are spaced apart

from one another a sufficient distance to permit the tip cap 40 to be received

therebetween.

The tip cap 40 has a base section 41 and a flange 43 that has a

diameter that is greater than the diameter of the base section 41. The gripping sections 344

of the arms 340, 350 are contoured to seat against the outer circumferential surface of the base section 41 of the tip cap 40. In the closed position, the gripping sections

344 of the arms 340, 350 are brought together so that they either seat against one

another or are in very close proximity to one another. When the gripping sections

344 come together in the closed position, the notches 360 define a complete circular

opening that has a diameter about equal to or slightly less than the diameter of the

base section 41 of the tip cap 40, thereby permitting the tip cap 40 to nest within the

gripping sections 344.

In Fig. 3, a first open position of the gripping arms 340, 350 is

illustrated with the gripping sections 344 being spaced sufficiently from one another so as to permit the tip cap 40 to be freely disposed between the gripping sections

344. Using a control unit 370 (e.g. , a programmable actuator, microprocessor,

etc.), the gripping arms 340, 350 are driven to the first position shown in Fig. 4.

The control unit 370 instructs the device 300 to perform an operation where the tip

cap 40 is gripped and removed by the device 300. When such an operation is

performed, the vertical base 310 is driven inwardly toward the dial 130 and relative

to the syringe 10 so that the gripping arms 340, 350 are positioned over the tip cap 40 that is disposed on top of the syringe 10. The vertical base 310 is then driven downward until the gripping arms 340, 350 are disposed around the tip cap 40. In

other words, the tip cap 40 is disposed between the gripping section 344 of the

opposing arms 340, 350 and more specifically, the gripping sections 344 are

disposed adjacent the base section 41 of the tip cap 40 underneath the flange 43 with

the notches 360 being aligned with the outer surface of the base section 41. An

actuator or the like of the device 300 is then activated causing the gripping arms

340, 350 to move inwardly toward one another until the gripping sections 344 seat

against the outer surface of the base section 41 of the tip cap 40. In this closed position, the gripping arms 340, 350 apply a force against the base section 41 so

that the tip cap 40 is securely held by the gripping sections 344. When the gripping

arms 340, 350 are driven to the closed position, the gripping sections 344 seat against one another and the notches 360 align such that the gripping sections 344

substantially encircle the base section 41.

The apparatus 300 can be driven in any number of different ways that

are known and suitable for this intended use. For example, the apparatus 300 can

be pneumatically based according to one exemplary embodiment and as shown in

Fig. 3. In this embodiment, a number of pneumatic conduits are provided for

moving the gripping arms 340, 350.

After the tip cap 40 is nested within the gripping sections 344, the

control unit 370 directs the vertical base 310 upward and this motion causes the tip cap 40 to be displaced from the barrel tip 28 as shown in phantom in Fig. 5. After the tip cap 40 is freed from the barrel tip 28, it remains held between the gripping

sections 344 of the opposing arms 340, 350. The vertical base 310 is then driven

more inward, as indicated by arrow 311, toward the dial 130 until the held tip cap 40 is positioned over the post 161. Once the tip cap 40 is disposed over the post

161, the controller 370 instructs the vertical base 310 to move downwardly so that

the post 161 is disposed within a hollow interior of the tip cap 40. The actuator is

then activated causing the gripping arms 340, 350 to move to the open position,

thereby releasing the tip cap 40 as shown in Fig. 5. Because the tip cap 40 sits on the post 161, its movement is restricted after the gripping arms 340, 350 release

their gripping action therefrom and the tip cap 40 remains seated on the post 161 as

the rotary device 130 advances to deliver the uncapped syringe 10 to another station.

The device 300 then is returned to its initial position, the dial 130 is advanced and

the operation is repeated with the device 300 gripping and removing one tip cap 40

from the next capped syringe 10.

Now referring to Figs. 6-8, the system 100 also includes a generic device 390 for extending the plunger 50 of one uncapped syringe 10 after it has had

its tip cap 40 removed therefrom. For ease of illustration, the device 390 as well as

the device 300 are described as being part of the third station 150 of the system 100.

The device extends the plunger 50 using an elongated member 392 that is

complementary to the plunger 50 so that an end 394 thereof seats with (above) the

plunger 50. The member 392 can be controllably driven up and down a

predetermined distance that corresponds to the distance the plunger 50 is extended

so that the syringe 10 can receive a desired dose based upon the particular syringe

10 being used and the type of application (e.g., patient's needs) that the syringe 10 is to be used for. The device can have any number of configurations so long as it

contains a feature that is designed to make contact with and withdraw the plunger

50. Fig. 27 is an exploded perspective view of the automated device 400

according to an embodiment that is similar to the general embodiment shown in Fig.

3; however, Fig. 27 illustrates in greater detail the working components for

removing, parking and replacing the syringe safety tip cap 40 and Fig. 28 is a side

elevation view of the automated device of Fig. 27. The exemplary device 400 is

formed of a number of working parts that are operatively connected to one another

and are also in communication with the controller that is preferably a programmable

unit, such as a personal computer or the like, which controls operation of the device

400 as well as other working components. As best shown in the exploded view of

Fig. 27, the device 400 includes a housing 410 and a tip cap gripper unit 440 that engages the tip cap 40 (Fig. 1) and removes it from syringe 10 and then securely

places or parks it on the dial 130 before a second device 900 at station 180 retrieves

the removed tip cap 40 from the dial 130 and then replacing the tip cap 40 on the

syringe 10. The gripper unit 400 is partially contained within the housing 410

except for the adjustable gripper parts that lie outside of the housing 410 so that they

can engage and remove the tip cap 40 of one syringe 10 as it is advanced along the

dial 130 (Fig. 2).

The exemplary housing 410 includes a front cover plate 412, a back

cover 414 and a base plate 416. The front cover plate 412 is a generally rectangular

plate that has a number of openings 417 formed therein to receive fasteners (not

shown) which securely couple the front cover plate 412 to the back cover 414. The

front cover plate 412 can also include one or more slots 418 that also receive

fasteners for securely coupling the front cover plate 412 to the base plate 416. For example, the slots 418 can be formed at one edge (e.g., the bottom edge) of the

front cover plate 412.

The back cover 414 has a substantially open front face 419 and is

formed of a top wall 420, a rear wall 421 and a pair of opposing side walls 422.

The top wall 420 has a cut-out 423 formed therein to accommodate movement of the

gripper unit 400 within the housing 410. The top wall 420 is generally square or

rectangular shaped and extends between the side walls 422 and the rear wall 421.

The opposing side walls 422 are mirror images of one another and are disposed

parallel to and spaced apart from one another. A front edge 424 of each side wall

422 includes a number of fastening tabs 425 that provide mounting surfaces for

securely attaching the front cover plate 412 to the back cover 414. Two of the

fastening tabs 425 are located at the intersection between the top wall 420 and the side walls 422 and two additional fastening tabs 425 are located below the two tabs

425 at the top wall 420. The illustrated tabs 425 are generally square shaped and

are disposed perpendicular to a plane that contains the respective side wall 422.

Openings 426 are formed in the fastening tabs 425 for receiving the fasteners and

are axially aligned with openings 417 of the front cover plate 412. The side walls

422 also include fastening slots 427 that receive fasteners for securely attaching the

side walls 422 to the base plate 416.

The base plate 416 is securely attached to the side walls 422 and the front cover plate 412. The base plate 416 has a shape and is dimensioned in a

complementary manner relative to the other parts of the housing 410. The

illustrated base plate 416 is generally rectangular shaped and is formed of a body

428 that includes end edges 429 and side edges 430. The end edges 429 have openings 431 formed therein to receive fasteners for coupling the front cover plate

412 to the base plate 416. Similarly, the side edges 430 have openings 432 that

receive fasteners for securely coupling the side walls 422 to the base plate 416. The

body 428 also includes openings 433 formed therein for securely mounting various

components to the base plate 416. For example, the gripper unit 440 is securely

attached to the base plate 416 using fasteners that extend through a number of these

openings 433.

Any number of different types of materials can be used for the

housing 410 and the shape thereof is also likely influenced by design considerations, such as the amount of available space near the dial 130. Thus, the illustrated

housing 410 is merely exemplary in nature and not limiting of the present housing

310. For example, the housing 410 can be formed of sheet metal, etc.

The gripper unit 450 is an assembled unit disposed at the third station

that is configured to remove the tip cap 40 from the barrel tip 28 of the syringe 10

and place it or park it on the post 161. The automated gripper unit 440 is a robotic device or an automated mechanical device and preferably, one exemplary automated

gripper unit 440 is a pneumatically operated device; however, the gripper unit 440

can be driven by a motor, etc. The automated gripper unit 440 includes a vertical

base 442 which is adjustable in at least several directions. For example, the vertical

base 442 has an independent reach (y axis) and vertical axis (x axis) which provides

part of the flexibility and motion control that is desirable for the unit 440. The vertical base 442 has an upper end 443 and an opposing lower end 444 which is

operatively coupled to other movable components, as will be described hereinafter,

to permit the vertical base 442 to move in an up/down direction along the x axis and in lateral directions along the y axis. The upper end 443 is connected to a horizontal support member 445 (e.g., a top bracket) that extends outwardly away

from the vertical base 442. In one exemplary embodiment, the lower end 444 is

securely attached to a support member 446.

A block member 448 is connected to the horizontal support member

445 and more specifically, the block member 448 is disposed on an underside of the

horizontal support member 445 so that it is spaced away from the vertical base 442.

The exemplary block member 448 has a block-like shape and is connected to the

underside of the horizontal support member 445 by one or more connectors, etc.

The gripper unit 440 has first and second positionable gripper arms

450 which are adjustable in at least one direction and which are coupled to and

extend downwardly from the block member 448. For example, each of the gripper

arms 450 is movable at least in a direction along the y axis to provide the flexibility

and motion control that is desirable in the present system 100. The gripper arms 450 are programmed to work together in tandem so that both arms 450 are driven

alike (e.g., either toward each other or away from one another) and at the same

time.

One knowledgeable in the state of the art will recognize that several

motion control devices (i.e., motors, hydraulic drives, pneumatics, etc.) can be used

to conduct the linear motion required of the various stations. In the present

invention, different motion control devices are used for their defined operations. For stations 150, 180, the motion control devices are powered by pneumatic pressure. Stations 150 and 180 each have three pneumatic motion control devices.

For each of these motion control devices, there is a constant pneumatic pressure forcing the certain component to its safe "Home" position and a single state valve that is actuated by input from the system controller that over pressurized, the

pneumatic cylinder so that the mechanical component can advance to the endstop

opposite to its "Home" position. The block member 448 can house some of the electronic or

pneumatic components and the like that permit the gripper arms 450 to move

between the open and closed positions. The coupling between the block member

448 and the gripper arms 450 is such that the gripper arms 450 have the necessary

degree of movement to permit the opening and closing thereof. Since the gripper unit 440 is preferably a pneumatic device, a number

of pneumatic controls are disposed near the gripper arms 450. More specifically,

the gripper arms 450 are pneumatic devices and therefore, a first pneumatic control

451 is connected to the block member 448. The first pneumatic control 451 is

integral to block member 448 and includes first and second flow control valves 452 that are of a point locked type, with the positions set at the time of manufacture.

For example, the valves 452 have adjusable knobs that permit a certified field

service engineer or technician to adjust the pneumatic pressure that is present at the gripper arms 450 to assist in the opening and closing of the gripper arms 450. As

will be appreciated, the unit 440 can be a pneumatically based system since the

operation of the vertical base 442 only requires the vertical base 442 to be driven

between two fixed positions in one direction of movement.

The gripper unit 440 also preferably includes a sensor assembly, generally indicated at 453, for sensing whether a tip cap 40 is present between the

gripper arms 450. One exemplary sensor assembly 453 includes a sensor device 454 and a reflector 455 that is spaced therefrom. The sensor device 454 is formed

of one or more sensors that are securely attached to a support bracket 456 that is

attached to the block member 448. The support bracket 456 has two sections that

each has an L-shape and therefore the bracket 456 resembles a series of steps. A

bottommost section 457 of the support bracket 456 is the section that holds the one

or more sensors 454. The support bracket 456 is disposed so that the gripper arms

450 lie between the support bracket 456 and the vertical base 442.

According to one exemplary embodiment, the sensors 454 are LED type sensors or the like which emit a light beam in a predetermined direction.

There are preferably two LED sensors 454 that emit light beams in a direction

toward the gripper arms 450 and more specifically, the light beams are targeted

between the gripper arms 450 where the tip cap 40 is to be located when the gripper

arms 450 properly grip and retain the tip cap 40.

The reflector 455 is securely attached to the vertical base 442 and is axially aligned with the sensors 453 so that when the sensors 453 are actuated, the

light beams are emitted from the sensors 453 and, if no obstruction is present, the

light beams pass across the space between the support bracket 456 and the inner face of the rear cover 414. If a tip cap 40 is present between the gripper arms 450, then

the light beams of the sensors 453 will be impinged or otherwise broken since the

tip cap 40 lies within the path of the light beam when it is securely held between the

gripper arms 450. When the tip cap 40 is present, the light beams of the sensors

453 do not make contact with the reflector and therefore, the light beams are not

reflected back to the sensors 453. Because the sensors 453 are in communication

with the control unit, a break in the light beam generates a control signal that is delivered to the control unit to indicate that an object, such as the tip cap 40, is

present between the gripper arms 450. Conversely, if the gripper arms 450 are

instructed to remove the tip cap 40, they are actuated and moved to a position for

gripping and retaining the tip cap 40 and if for some reason, the tip cap 40 is not removed properly, then the sensor's light beam is not impinged by the tip cap 40.

The light beam of the sensors 483 pass completely to the reflector 485 since there is

no tip cap 40 present between the gripper arms 450. The control unit therefore does

not receive the control signal indicating the presence of one tip cap 40 between the

gripper arms 450. After a predetermined time period, the control unit will reject the

syringe 10 if the presence of the tip cap 40 is not detected. Once the syringe 10 is

rejected, the dial 130 is advanced and the tip cap process is started over with the

next adjacent syringe 10 on the dial 130 being advanced so that it is in position for

the gripper unit 440 to act and remove the tip cap 40. If the sensor device 453

detects the presence of a tip cap 40 at a time when the presence is expected, the

control signal from the sensor device 453 is received by the control unit and the

gripper unit 440 is instructed to continue its process of removing, parking, or

replacing the tip cap 40.

The gripper unit 440 includes a number of pneumatic control devices

and more specifically, the gripper unit 440 includes a second pneumatic control

device 457 and a third pneumatic control device 458. The second pneumatic control

device 457 controls movement of the vertical base 442 in towards and out away

from the dial 130. In other words, the second pneumatic control device 457 moves the vertical base 442, as well as the gripper arms 450, in a direction toward the dial

130 and in a direction away from the dial 130. The second pneumatic control device 457 is similar to the previously described motion control device with its "Home" position being out, away from the dial 130.

In the illustrated embodiment, the second pneumatic control device

457 is disposed at a lower end of the vertical base 442 and preferably is operatively

coupled thereto so that actuation of the control device causes the selective,

controlled movement of the vertical base 442 in and out from the dial 130. As

shown in Fig. 27, both the lower end of the vertical base 442 and the second

pneumatic control device 457 are disposed on a support surface 459 of the support

member 446. More specifically, the support member 446 has one or more guide

tracks formed therein to permit the controlled in and out movement of the vertical

base 442. As the vertical base 442 moves in the in and out directions, it moves

from one end of the support member 446 to the other end of the support member

446 in a controlled manner so that the gripper arms 450 are moved from an out

position, where the gripper arms 450 are disposed away from the dial 130 as

represented in Fig. 27, to in out position, where the gripper arms 450 are disposed

above the dial 130. In this embodiment where pneumatic controls are used, the

vertical base 442 travels a fixed distance, namely the distance between the out

position and the in position and vice versa.

The second pneumatic control device 457 includes a number of

adjustable control features that permit a certified field service engineer or technician

to vary the operating parameters of the device 457. For example, the second

pneumatic control device 457 can include one or more control valves 460 for controlling and adjusting the pneumatic pressure within the second pneumatic

control device 457. In the illustrated embodiment, these control valves 460 are in the form of control knobs that can be easily adjusted by a certified field service

engineer or technician.

The third pneumatic control device 458 controls movement of the

vertical base 442 in the up-down directions. In other words, the third pneumatic

control device 458 moves the vertical base 442, as well as the gripper arms 450, and

the second pneumatic control device 457 in a vertical direction. The third

pneumatic control device 458 is similar to the previously described motion control device with its "home" position being up, keeping the gripper mechanism 450 away

from the dial 130.

In the illustrated embodiment, the third pneumatic control device 458

is disposed below the support member 446 and therefore is generally below the

lower end of the vertical base 442. Preferably, the third pneumatic control device

458 is operatively coupled to the support member 446 so that actuation of the third

pneumatic control device 458 causes the selective, controlled movement of the vertical base 442 in up-down directions. As previously specified, one

knowledgeable in the state of the art recognizes that controlling the vertical motion

of certain components connected to the support member 446 can be accomplished by

one of a number of motion controllers (i.e., motors, hydraulic lines, pneumatics,

etc.). In the present invention, the up-down movement of the vertical base 442 can

be caused by a pneumatic cylinder or other moving parts that are pneumatically

driven.

As the vertical base 442 moves in the up and down directions, the

vertical base 442 is raised and lowered relative to the housing 410 in a controlled

manner so that the gripper arms 450 are moved from a raised position, where the gripper arms 450 are disposed a maximum distance away from the upper surface of

the dial 130, to a lowered position, where the gripper arms 450 are disposed a

minimum distance from the upper surface of the dial 130. This lowered position

allows for interaction with the tip cap 40 and either the syringe tip 28 or pin 161. In

this embodiment where pneumatic controls are used, the vertical base 442 travels a

fixed distance, namely the distance between the raised position and the lowered

position and vice versa.

The third pneumatic control device 458 includes a number of

adjustable control features that permit a trained and certified field service engineer

or technician to vary the operating parameters of the device 458. For example, the

third pneumatic control device 458 can include one or more control valves 462 for

controlling and adjusting the pneumatic pressure within the third pneumatic control

device 458. In the illustrated embodiment, these control valves 462 are in the form

of control knobs that can be easily adjusted by a trained and certified field service

engineer or technician.

The unit 450 (Fig. 27) also includes a connector module 463 that is

disposed within the housing 410 and is securely attached to the base plate 416 using

a pair of angled mounting brackets 464. The brackets 464 are spaced apart from

one another and are mounted to the base plate 416 using fasteners 465 or the like. Each bracket 464 includes a planar surface 466 that has an opening 467 formed

therethrough to receive a fastener for mounting a module 468 to the clamps 464.

The module 468 is the input/output connector block for the entire station 150. At

each end of the module 468, an end stop 469 is provided for limiting the movement

of the module 468. More specifically, the end stops 469 keep the module 468 I/O blocks from sliding off the railed tray to which the module 468 is mounted. The

connector module 468 is located adjacent the unit 450 and more specifically, it is

located behind the third pneumatic control device 458 (e.g., closer to the rear wall

414). The connector module 468 is thus disposed between the unit 450 and the rear

wall 414.

The operation of the gripper unit 450 is now described in detail. To

remove a tip cap 40, the third pneumatic control device 458 is deactivated (valve is closed) so that the vertical base 442 and the gripper arms are in the raised position.

At the same time, the second pneumatic control device 457 is not actuated (valve

closed) and therefore, the vertical base 442 is in the out position. For ease of

description, this orientation is referred to as a starting position which permits the dial 130 to be advanced so that one syringe 10 is delivered to a position where the

syringe 10 is in axial alignment with the gripper arms 450. The gripper arms 450

are in a closed position in the starting position to permit entry of the tip cap 40

therebetween. In other words, the first pneumatic control is in an deactivated

position, thereby causing the two gripper arms 450 to be closed. When the syringe

10 is advanced to a position where the gripper arms 450 are axially aligned with the

syringe 10, the syringe 10 likewise is in a start position.

To initiate the tip cap removal cycle, the first pneumatic control

device is activated so that the gripper arms 450 are opened. The third pneumatic control device 458 is then activated so that the pressure in the valves 462 is

released, thereby causing the device 458 to assume the lowered position. In this

lowered position, the tip cap 40 of the syringe 10 is disposed between the gripper

arms 440 and then the first pneumatic control is deactivated so that the gripper arms 450 are closed and the tip cap 40 is nested within the gripper arms 450. Because of

the complementary shape of the gripper arms 450, the tip cap 40 is securely held

therebetween and is ready to be removed from the syringe 10.

To remove the tip cap 40 from the syringe 10, the third pneumatic control device 458 is deactivated so that it moves to the raised position. Because the

first pneumatic control remains deactivated, the gripper arms 450 remain in

engagement with the tip cap 40 as the third pneumatic control device 458 assumes

the raised position and this movement in a direction away from the syringe 10 causes the tip cap 40 to be lifted off of the syringe 10 as it is held between the

gripper arms 450. It will be appreciated that the sensor device 453 is preferably

used to sense whether the tip cap 40 is securely being held by the gripper arms 450.

More specifically, the light beam of the sensor 453 is broken when the tip cap 40

comes between the sensor 453 and the reflector 455 and this signals to the controller

that an object, e.g., the tip cap 40, is present between the closed gripper arms 440.

If the sensor 453 does not detect the presence of a tip cap 40 when the gripper arms

450 are closed in this position, then the controller will cause the vertical base 442 to

return to the start position and the removal and parking operations are started again.

For ease of discussion, the controller is discussed as being a master

controller that is operatively connected to each of the working components of the

present device. This controller is therefore in communication with the working

components and receives feedback and signals therefrom as well as sends signals to the various working components to ensure the proper operation thereof. It will be

appreciated that there are a number of different ways that the controllers can be

arranged. For example, each working component can have its own controller, which in turn is communicatively connected to the other working components

through a master controller or the like.

Once the third pneumatic control device 458 reaches the raised

position, the

second pneumatic control 457 is then actuated and this causes the vertical base 442

to go from the out position to the in position. In the in position, the gripper arms

450 holding the tip cap 40 are disposed immediately above the pin (post) 161 for

parking of the tip cap thereon. In other words, movement of the vertical base 442

from the out position to the in position causes the gripper arms 450 to move from a

position over the tip cap 40 to a position over the pin 161. The tip cap 40 is now

ready for parking on the pin 161.

To park or place the tip cap 40 on the pin 161, the third pneumatic

control device 458 is activated (valve is open) so that the third pneumatic control

device 458 moves back to the lowered position. In the lowered position, the gripper

arms 450 are immediately above the pin 161. The tip cap 40 is also axially aligned

on the pin 161 so that release of the tip cap 40 results in the tip cap 40 being held by

the pin 161. To release the tip cap 40, the first pneumatic control is activated (valve

is opened) so that the gripper arms 450 move from the closed position to the open

position. As the gripper arms 450 move apart from one another, the tip cap 40 is

released from the grip thereof.

Once the tip cap 40 is securely retained on the pin 161, the third

pneumatic control device 458 is deactivated so that the vertical base 442 moves from

the lowered position to the raised position where the gripper arms 450 are a

significant distance from the dial 130. In addition to the actuation of the third pneumatic control device 458, the second pneumatic control device 457 is

deactuated resulting in the vertical base 442 moving from the in position to the out

position. This movement facilitates the further advancement of the dial 130 and the syringe 10 since the gripper arms 450 are moved away from the dial 130 so as to

not obscure access thereto. It will be appreciated that the vertical base 442 has now

reassumed the starting position and the process can be repeated by advancing the

dial 130 so that another syringe 10 is brought into place and the various components

of the gripper unit 450 are then controlled and moved in the manner just previously

described for gripping, removing, and parking the tip cap 40 on the pin 161.

Referring now to Figs. 29-32 and according to another aspect of the

present invention, the system 100 includes an automated device 1400 for

withdrawing a plunger a predetermined distance to permit the injection of a

preselected volume of medication into the barrel 20. In the system configuration of

Fig. 2, the device 1400 is located at the fourth station. More specifically, these

figures illustrate a part of the fourth station for preparing a syringe for later use and

more specifically, an automated device 1400 for withdrawing (extending) the plunger 50 of the syringe 10 a prescribed amount after it has had its tip cap 40

removed therefrom.

Fig. 29 is a front perspective view of the device 1400 and Fig. 31 is

an exploded perspective view of the device 1400. The exemplary device 1400 is

unit, such as a personal computer or the like, and which controls operation of the device 1400. As best shown in the exploded view of Fig. 31, the device 1400 includes a housing 1410 and a positionable, automated puller 1500 that engages the

plunger 50 (Fig. 1) and extends it a calculated distance based on a number of

parameters that are inputted into the controller as will be described hereinafter in

reference to the operation of the device 1400. The puller 1500 is substantially

contained within the housing 1410 except for the adjustable puller parts that lie

outside of the housing 1410 so that they can engage and extend the plunger 50 of

one syringe 10 as it is advanced along the dial 130 (Fig. 2).

The exemplary housing 1410 includes a front cover 1420, a back

cover 1440 and a base plate 1450. The front cover 1420 has a front face 1422 that extends from an upper end 1423 to a lower end 1425 with a cut out 1426 being

formed therein and extending from a location proximate the upper end 1423 to the

lower end 1425. In the exemplary embodiment, the front face 1422 has a

substantially rectangular shape, with the cut out 1426 also having a substantially

rectangular shape. The front cover 1420 also includes two opposing and spaced side

faces or walls 1428 that are integrally attached to the front face 1422 along a front

edge 1427 (vertical edge) thereof. The side walls 1428 also include a rear edge

1429 that is integrally attached to the back cover 1430. Unlike the front edge 1427, which is linear in nature, the rear edge 1429 is not linear in nature but rather has an

irregular shape (e.g. , non-linear). The front cover 1420 also includes an upper face

or wall 1430 that is integrally attached to the upper edges of the front face 1422 and

the side walls 1428. The front cover 1420 is constructed preferably as a single

integral unit and a slight gap 1432 is formed between the lower end 1425 of the front face 1422 and a ground contacting surface for receiving and permitting the

base plate 1450 to be securely attached to both the front cover 1420 and the back cover 1440. The gap 1432 is formed because the height of the front face 1422 is

less than the height of the side walls 1428; however, they are each integrally

connected to the upper wall 1430 and therefore, the gap 1432 is formed at the

bottom of the housing 1410. The front cover 1420 has a number of features formed therein for

coupling the front cover 1420 to other parts. For example, the side walls 1428 can

include openings or slots 1431 for receiving fasteners to securely attach the side

walls 1428 to the base plate 1450.

The back cover 1440 has a shape complementary to the rear edge

1429 to permit the back cover 1440 to seat against and be securely attached to the

side walls 1428 at the rear edges 1429 thereof. The exemplary back cover 1440 has

an angled or beveled construction and is generally formed of a first section 1442 that is securely attached to the rear edges 1429 of the side walls 1428. The back

cover 1440 also includes second and third sections 1443, 1445, respectively. The

second section 1443 is an intermediate section that lies between the first and third

sections 1442, 1445. The first section 1442 is disposed at the upper end of the

housing 1410 where the upper wall 1430 is located. In the assembled state, the first section 1442 is substantially perpendicular to the ground contacting surface, as well

as the base plate 1450. The first section 1442 has a cut out 1447 formed therein to

permit access to the interior of the housing 1410. The first section 1442 also

includes openings 1444 for receiving fasteners to securely attach the first section

1442 to the side walls 1428.

The second section 1443 does not lie within the same plane as the

first and third sections 1442, 1445. The second section 1443 is generally rectangular in shape and is a beveled surface with respect to the first and third

sections 1442, 1445. When the back cover 1440 is attached to the side walls 1428,

the second section 1443 seats against a complementary shaped beveled surface that

forms a part of the rear edges 1429 of the side walls 1428. The second section 1443

also includes openings 1444 for receiving fasteners to securely attach the second

section 1443 to the rear edges 1429 of the side walls 1428.

Similar to the first section 1442, the third section 1445 is substantially

perpendicular to the ground contacting surface, as well as the base plate 1450. The

first and third sections 1442, 1445 thus lie in planes that are substantially parallel to

one another; however, the planes are off set or spaced apart from one another. The third section 1445 also includes openings 1444 for receiving fasteners to securely

attach the third section 1445 to the rear edges 1429 of the side walls 1428. When

the back cover 1440 is securely attached to the front cover 1420, an interior

compartment 1460 is formed and is configured to receive the puller 1500.

The base plate 1450 serves as the bottom of the housing 1410 and is

sized and configured to be received between the side walls 1428 and within the gap

1432. In one exemplary embodiment, the base plate 1450 is generally square or

rectangular shaped. The base plate 1450 has a number of features formed therein to

facilitate attachment of the base plate 1450 to the side walls 1428 (as well as the attachment of the puller 1500 to the base plate 1450). The base plate 1450 has two

opposing side edges 1452 and a body 1454 with the opposing side edges 1452

having openings 1456 formed therein to receive fasteners. The fasteners extend through the openings or slots 1431 formed in the side walls 1428 and then through

the openings 1456 to provide a secure attachment between the side walls 1428 and the base plate 1450. The body 1454 has a number of openings, channels and/or

slots 1455 formed therethrough. For example, there are a number of thru openings 1455 that receive fasteners that threadlingly mate with complementary features

formed in the puller 1500, to thereby securely attach the puller 1500 to the base

plate 1450.

To assemble the housing 1410, the base plate 1450 is disposed

between the side walls 1428 so that one end region of the base plate 1450 is

disposed underneath the lower edge of the front face 1422. The openings 1431,

1452 are aligned to permit connection between the base plate 1450 and the side

walls 1428. Since the base plate 1450 is perpendicular to the other housing

components which are vertical in nature, the base plate 1450 provides a support platform for the device 1400. The back cover 1440 can then be attached to the side

walls 1428 of the front cover 1420 in the manner described hereinbefore after the

puller 1500 has been securely mounted to the base plate 1450 as will be described

hereinafter.

Any number of different types of materials can be used for the

housing 1410 and the shape thereof is also likely influenced by design

considerations, such as the amount of available space near the dial 130. Thus, the

illustrated housing 1410 is merely exemplary in nature and not limiting of the

present housing 1410. For example, the housing 1410 can be formed of sheet

metal, etc.

The puller 1500 is an assembled unit that serves to engage the

plunger 50 (Fig. 1) and extend it a calculated distance. The puller 1500 has a

support frame 1510 that has a first end 1512 and an opposing second end 1514 and a carrier 1550 that is controllably movable along a length of the support frame 1510

by way of a drive means, generally indicated at 1560. The carrier 1550 supports a

plunger gripper 1570 which serves to engage and extend the plunger 50 (Fig. 1) as

will be described in greater detail hereinafter.

The support frame 1510 has a first section 1511 at or near the first

end 1512 for supporting the drive means 1560 and a second section 1513 that is

disposed underneath the first section 1511 and extends to the second end 1514. A

mounting base 1516 is also provided as part of the support frame 1510 and is

integrally connected to the second section 1513. A bottom face of the mounting

base 1516 receives the fasteners resulting in the unit 1500 being securely attached to

the base plate 1450. Thus, the support frame of the unit 1500 is fixed stationary

within the interior compartment of the housing 1510 and the principle moving parts

are the carrier 1550 and the plunger gripper 1570 that is mounted thereto, as well as

parts of the drive means 1560.

The second section 1513 acts as a support section as well as a guide

section since it restricts the movement of the carrier 1550 to an up and down

(vertical) movement along the length of the vertical second section 1513. The second section 1513 includes two opposing end posts 1520 that are preferably in the

form of elongated posts or rails that are arranged in a vertical orientation. In the

illustrated embodiment, the rails 1520 have a substantially rectangular cross-

sectional shape. The rails 1520 extend between a first horizontal member 1522 and

a second horizontal member 1524 at the second end 1514 of the housing 1510. The

rails 1520 are spaced apart from one another so that a space is formed therebetween and an outermost edge 1525 of each rail 1520 is a smooth surface to permit the rear face of the carrier 1550 to move therealong.

The drive means 1560 is a device which, when actuated, drives the carrier 1550 in one of two directions vertically along the second section 1513.

More specifically, actuation of the drive means 1560 in a first mode causes the

carrier 1550 to move in a first direction (up or down direction) and actuation of the

drive means 1560 in a second mode causes the carrier 1550 to move in an opposing

second direction (the opposite up or down direction) along the second section 1513.

One exemplary drive means 1560 is a screw drive mechanism that includes a motor

1562 that is operatively connected to a screw drive type mechanism. More specifically and according to one exemplary embodiment, the motor 1562 is a servo

(stepper) motor and the screw drive mechanism includes a drive spindle or drive

cable that includes screw coils. The use of a screw drive mechanism is conventional

and therefore, the present screw drive mechanism is not described in great detail. As the drive spindle or drive cable is turned around (rotated) its

lengthwise

direction, the screw coil "migrates" in the lengthwise direction for displacing the

carrier 1550 vertically (either up or down) along a length of the second section

1513. When the drive spindle is turned around (rotated) in an opposite direction, the carrier 1550 moves in the opposite vertical direction. One part 1564 of the

screw drive means 1560 is disposed between the two spaced rails 1520. The part

1564 is also an elongated member that is disposed between the two rails 1522 in a

parallel manner. The first section 1511 is generally in the form of a U-shaped member

defined by two legs 1515 and a wall 1517 extending between and connecting the two legs 1515 to one another. The first section 1511 has a through bore or opening

formed therethrough with the drive means 1560 disposed adjacent one leg 1515 of

the first section 1511. The first section 1511 is also attached securely to the second

section 1513. The opening thus extends through both legs 1515.

The carrier 1550 is formed of a body that has a first end and an

opposing second end with the first end facing the motor 1562 and the second end

facing the second horizontal member 1524. The carrier 1550 has a front face that is

securely attached to the plunger gripper 1570 using fasteners or other means. The

elongated part 1564 is operatively coupled to the first end of the carrier 1550 so that

actuation of the motor 1562 and rotation of the drive spindle is translated into up or

down movement of the carrier 1550 as is the case in a screw drive mechanism

where the screw drive spindle drives a carrier or the like. The carrier 1550 also

includes two side edges 1552 that preferably do not extend beyond the two rails

1522.

The puller 1500 also has an indicator feature for notifying the

controller that the carrier 1550 has reached one end of its permitted length of travel. For example, the puller 1500 can have a first sensor 1580 at one end of the

permitted length of travel and a second sensor 1582 at an opposite end of the

permitted length of travel. More specifically, the first sensor 1580 and the second

sensor 1582 are of the types that have a beam that extends across a gap from one

section of the sensor to another section of the sensor and the sensor is triggered

when an object breaks the beam by passing through this gap. In one exemplary embodiment, each of the first and second sensors 1580, 1582 is a U-shaped bracket

sensor having spaced apart arms 1584 that define a gap or space 1586 therebetween.

The beam extends across the gap 1586 from one arm 1584 to the opposing arm 1584

and the sensors 1580, 1582 are in communication with the controller so that once an

object impinges the beam, a signal is sent to the controller to indicate the occurrence

of such event.

The indicator feature also includes a flag or marker 1590 that is part

of the carrier 1550 for tripping one of the sensors 1580, 1582 when the carrier 1550

is in either a maximum up position or a maximum down position. For example, the

flag 1590 can be a member that is secured to the carrier 1550 at one side edge 1552.

Because the side edges 1555 preferably do not extend beyond the two rails 1522, the flag 1590 is L-shaped with one section being secured to the front face 1554 of the

carrier 1550 and another section that is perpendicular to the one section being

disposed parallel to and spaced from the respective side edge 1552. The flag 1590

is configured and mounted to the carrier 1550 so that it is axially aligned with the

respective gaps 1586 of the two sensors 1580, 1582 and therefore, as the carrier

1550 travels either in an up or down direction, the flag 1590 will at some point enter

one of the gaps 1586 and break the beam that passes across the respective sensor 1580, 1582. As soon as the flag 1590 breaks the beam, a signal is sent from the

respective sensor 1580, 1582 to the controller to indicate that such an event has

occurred and the controller 470 will then take the necessary steps to stop further

movement of the carrier. In other words, the tripping of the sensors 1580, 1582 is

an event that only occurs when the carrier 1550 and surrounding components have

been driven to its maximum up or down positions and in order to protect the integrity of the carrier 1550, the drive mechanism and the other operative and non-

operative parts of the puller 1500, the controller will instruct the motor 1564 to stop

its drive action, thereby preventing the carrier 1550 from continued movement in the same direction. Because the portion of the flag 1590 that breaks the beam is a

vertical wall, an upper edge of this vertical wall is the section that breaks the beam

in the sensor 1580 and a lower edge of this vertical wall is the section that breaks

the beam in the sensor 1582. The height of the vertical wall of the flag 1590 is approximately equal to the height of the carrier 1550 so that the flag 1590 trips the

sensors 1580, 1582 before any section of the carrier before or below the flag 1590

can strike another object due to excessive travel. The distance between the sensors

1580, 1582 is predetermined so that it correlates to the maximum up position and

maximum down position of the carrier 1550 and the normal operation positions of

the carrier 1550 lie linearly along the second section 1513 between the two sensors

1580, 1582. The sensor 1580, 1582 are thus mounted to the puller 1500 in

locations that are laterally beyond the rails 1522 so that the sensors 1580, 1582 do

not interfere with the up and down traveling of the carrier 1550.

The puller 1500 includes the plunger gripper 1570 that is securely

mounted to the carrier 1550 such that movement of the carrier 1550 is directly

translated into the same directional movement of the gripper 1570. The exemplary

gripper 1570 is a generally U-shaped member having first and second vertical walls

1571, 1572 that have first ends 1573 and opposing second ends 1574. At the second

ends 1574 thereof, the vertical walls 1571, 1572 are attached to a horizontal wall

1575 that extends between the vertical walls 1571, 1572 and serves to space the

walls 1571, 1572 from one another. A space 1576 is thus formed between the vertical walls 1571, 1572 and this space 1576 is open at the ends of the vertical

walls 1571, 1572 so that an object can be received at one end and pass into the

space before exiting the space 1576 at the other end.

At the first ends 1574, the vertical walls 1571, 1572 are attached to

flange members 1577. Each flange member 1577 is configured and mounted to one

of the vertical walls 1571, 1572 so that a portion (edge) of the flange member 1577

extends beyond the periphery of the vertical wall 1571, 1572 and into the space

1576. In other words, the flange members 1577 overhang respective vertical walls 1571, 1572 as best shown in Fig. xxx. The distance between the flange members

1577 is thus less than a distance between the vertical walls 1571, 1572. This

distance between the flange members 1577 is selected in view of the diameter of the plunger 50 such that the diameter of the plunger 50 is greater than the distance

between the flange members 1577 and therefore when the plunger 50 is disposed on

the underside of the flange members 1577 it is unable to travel between the flange

members 1577 even if a force is applied thereto. The distance between the vertical

walls 1571, 1572 is great enough to receive the plunger 50 and therefore, the

syringe 10 can be introduced into the space 1576 at one end with the plunger 50 lying within the space 1576 before the flange members 1577 engage the plunger 50

and cause the extension thereof as will be described hereinafter.

The actuation of the drive motor 1562 causes the drive mechamsm to

be driven and this is translated into controlled movement of the carrier 1550 and the

plunger gripper 1570. The carrier 1550 is driven a predetermined distance and to a

predetermined location by utilizing the precise controllability of the drive motor

1562. More specifically, the drive motor 1562 is preferably a conventional servo motor and therefore the actuation of the drive motor 1562 causes the drive motor

1562 to undertake an operating movement which is represented by a number of steps

of the drive motor 1562. In other words, the number of steps that the drive motor

1562 goes through is continuously determined, monitored and controllable. The

drive motor 1562 is preferably in communication with the main controller and control signals can be sent from the controller to the drive motor 1562 to control the

operation thereof.

According to the present invention, the degree of movement of the

carrier 1550 and the number of steps of the drive motor 1562 is calibrated so that

the number of steps of the drive motor 1562 is equated to the carrier 1550 moving a

predetermined distance. For example and for a specific syringe type, the drive motor 1562 being driven through 20,000 steps causes the carrier 1550 to move 5

cm. These measurements are specific to a given type of syringe 10.

The operation of the puller 1500 will now be described in greater

detail. At the beginning of each operation, the carrier 1550 is in the up (top)

position. Because the master controller is preferably a programmable unit, the user

can input information about a number of different types of syringes that can be used

in the present system or filling instructions. For example, there is a useful feature

of the present device that involves the ability to set an overdraw on the syringe.

The device installation includes an adjustment that "teaches" it where the fully

extended (10 ml) position is on the syringe. The controller software determines all

other volumetric positions from that position. As a result, teaching the device that the 10 ml position is actually at 10.4 ml, for example, the controlling software in

the controller can cause all positioning to be overdrawn by 0.4 ml. This is useful in adding a slight air gap at the top of the syringe to prevent overfilling and splashing

as the syringe is filled.

Further, the amount or distance that the carrier 1550 is driven

depends upon the desired volume of fluid that is to be injected into the syringe 10,

any additional filling specifications, and also depends upon the precise

characteristics of the syringe 10. For example, the user may program the controller

to fill the syringe 10 with 10 ml of medication and upon receipt of this request, the

controller (e.g. , the CPU thereof) calculates the distance that the plunger 50 needs

to be extended in order for 10 ml to be received within the barrel 20 based on

specific syringe product information inputted by the user as described above.

Because there is a correlation between the number of steps that the drive motor 1562 is driven through and the distance that the carrier 1550 is driven, the master

controller instructs the drive motor 1562 to be driven through a predetermined,

specific number of steps that corresponds to the carrier 1550 being driven precisely the distance that is equated with the syringe 10 receiving 10 ml of medication. For

example, the predetermined distance that the carrier 1550 is to be driven to receive

the 10 ml medication can be 5 cm and therefore, the drive motor 1562 is driven

20,000 steps, which correlates with the carrier 1550 moving precisely 5 cm. If the

user instructs only 5 ml of medication to be injected into the syringe 10, the master

controller will recalculate the necessary distance for the plunger 50 to be extended and the number of steps through which the drive motor 1562 is driven which will

result in the carrier 1550 being moved the necessary distance to ensure that the plunger 50 travels the desired distance. Unlike many of the conventional automated systems, the present

system provides many more options for the user and also permits the distance that

the plunger is extended to be readily changed. More specifically, the user only has to input the necessary information, such as the syringe type, and because the

controller is a programmable unit, it includes databases of information. The

controller accesses these databases and is able to retrieve the syringe characteristics

based on the limited information that the user provided. For example, the barrel diameter and the volume specifics about the barrel are determined and then based on

the inputted desired (target) volume of the prescribed dose, the controller computes

the distance that the plunger needs to be extended in order to form a dosage

receiving space of sufficient and optimal dimension. The distance that the plunger is extended can thus be readily changed since it is not restricted to any type of

mechanical adjustment but rather it is only determined by the information inputted

by the user and therefore it can be readily changed. For example, the user can input

a sequence of commands to cause the same type of syringe to be prepared

differently in two different batches, namely, a first batch in which the plunger is

extended a first distance (to receive first dose volume) and a second batch in which

the plunger is extended a second distance (to receive a second dose volume).

Conventional devices do not offer such versatility since they are typically arranged or mechanically set to perform a given task, i.e., extend the plunger only one

distance.

The software of the programmable controller is written so that it

contains calibration tables for various syringe types. In other words, for any given

syringe, a predetermined distance that the plunger 50 is moved is equated to a predetermined volume of medication that is received within the plunger 50. For

example, extending the plunger 50 of a given syringe 10 a distance of 10 cm is

equated to a dose of 5 ml of medication for reception within the barrel 20.

Optionally, the software of the controller can be configured so as to permit variable overfill of medication within the syringe 10 based on customer

preference. In other words, a given customer may wish for the medication to be

slightly overfilled for each unit dose that is injected into the syringe 10. For

example, for an application where 10 ml is to be delivered to the syringe 10, the controller will consult the calibration table to determine that the plunger needs to be

extended 3 cm for a 10 ml dose and moreover, because the customer code that is

preferably entered into the controller indicates that special customer instructions

have been supplied by the customer, the controller determines that this customer has

instructed that each dose be overfilled by 0.2 ml and this requires that the plunger

50 be extended 3.02 cm. The customer can enter the amount of overfill for each

dose volume or the customer can instruct that the syringe 10 be overfilled across the board regardless of the size of the dose. In other words, the customer can instruct

that for each dose filling, the syringe 10 is overfilled by 0.2 ml of medication. This

amount of overfill is then equated to a modified distance that the plunger 50 is

extended.

Thus, the device 1500 complements the device 400 in getting the

syringe 10 ready for the fluid transfer station at which time, a prescribed amount of

medication is dispensed into the chamber 30 of the barrel 20 as will be described in

greater detail hereinafter. Now turning to Figs. 2 and 9-20 in which a drug preparation area is

illustrated in greater detail to show the individual components thereof. More

specifically, a drug transfer area 500 is illustrated and is located proximate the

rotary dial 130 so that after one drug vial 60 is prepared, the contents thereof can be

easily delivered to syringes 10 that are securely held in nested fashion on the rotary dial 130. As previously mentioned, drug vials 60 are stored typically in the storage

cabinet 110 and can be in either liquid form or solid form. A driven member, such

as a conveyor belt 111 delivers the drug vial 60 from the cabinet 110 to a first pivotable vial gripper mechanism 510 that receives the vial 60 in a horizontal position and after gripping the vial with arms or the like, the mechanism 510 pivots

upright so that the vial 60 is moved a vertical position relative to the ground and is

held in an upright manner.

The mechamsm 510 is designed to deliver the vial 60 to a rotatable

pedestal 520 that receives the vial 60 once the gripper s of the mechanism 510 are

released. The vial 60 sits upright on the pedestal 520 near one edge thereof that

faces the mechanism 510 and is then rotated so that the vial 60 is moved toward the

other side of the pedestal 520. As the pedestal rotates, the vial 60 is scanned and a

photoimage thereof is taken and the vial 60 is identified. If the vial 60 is not the

correct vial, then the vial 60 is not used and is discarded using a gripper device that

can capture and remove the vial 60 from the pedestal before it is delivered to the f next processing station. The central control has a database that stores all the identifying information for the vials 60 and therefore, when a dose is being

prepared, the controller knows which vial (by its identifying information) is to be

delivered from the cabinet 110 to the pedestal 520. If the scanning process and other safety features does not result in a clear positive identification of the vial as

compared to the stored identifying information, then the vial is automatically

discarded and the controller will instruct the system to start over and retrieve a new

vial. If the vial 60 is identified as being the correct vial, then a vial gripper

device 530 moves over to the pedestal for retrieving the vial 60. The vial gripper

device 530 is configured to securely grip and carry the vial in a nested manner to

the next stations as the drug is prepared for use. For example, the device 530 can

include a vertical base 532 that is operatively coupled to a moveable base portion

534 that can ride within tracks to permit the device 530 to move not only in

forward-rearward directions but also in a side-to-side manner. At a distal end of the

vertical base 532, a gripper unit 540 is provided and is operatively coupled to the

vertical base 532 so that the gripper unit 540 can move in an up-and-down direction.

For example, the gripper unit 540 can be pneumatically supported on the vertical base 532 so that activation of the pneumatic mechanism causes either up or down

movement of the gripper unit 540 relative to the vertical base 532. The gripper unit

540 includes a pair of grippers or arms 542 that are positionable between closed and

open positions with the vial 60 being captured between the arms 542 in the closed

position in such a manner that the vial 60 can be securely moved and even inverted

and shaken without concern that the vial 60 will become dislodged and fall from the

arms 542. The arms 542 thus have a complementary shape as the vial 60 so that

when the arms 542 close, they engage the vial and nest around a portion (e.g., neck portion) of the vial 60 resulting in the vial 60 being securely captured between the arms 542. As with some of the other components, the arms 542 can be

pneumatically operated arms.

In order to retrieve the vial 60 from the pedestal 520, the device 530

is driven forward and then to one side so that it is position proximate the pedestal

520. The gripper unit 540 is then moved downward so that the arms 542, in their

open position, are spaced apart with the vial 60 being located between the open arms

542. The gripper unit 540 is then actuated so that the arms 542 close and capture

the vial 60 between the arms 542. Next the gripper unit 540 is moved upward and

the device 530 is driven back to the opposite side so as to introduce the vial 60 to

the next station. The vial 60 is also inverted by inversion of the gripper unit 540 so

that the vial 60 is disposed upside down.

The inverted vial 60 is then delivered to a station 550 where the vial

60 is prepared by removing the safety cap from vial 60. This station 550 can

therefore be called a vial decapper station. Any number of devices can be used at

-station 550 to remove the safety cap from the vial. For example, several exemplary

decapper devices are disclosed in commonly-assigned U.S. Patent No. 6,604,903

which is hereby incorporated by reference in its entirety. After the vial 60 is decapped, the vial is then delivered, still in the inverted position, to a cleaning

station 560 where the exposed end of the vial is cleaned. For example, underneath

the removed vial safety cap, there is a septum that can be pierced to gain access to

the contents of the vial. The cleaning station 560 can be in the form of a swab

station that has a wick saturated with a cleaning solution, such as an alcohol. The

exposed area of the vial 60 is cleaned by making several passes over the saturated

wick which contacts and baths the exposed area with cleaning solution. After the vial 60 is cleaned at the station 560, the gripper unit 540 rotates so that the vial 60 is

returned to its upright position and remains held between the gripper arms 542.

The device 530 then advances forward to a fluid transfer station 570.

The fluid transfer station 570 is an automated station where the medication (drug)

can be processed so that it is in a proper form for injection into one of the syringes

10 that is coupled to the rotary dial 130. When the vial 60 contains only a solid

medication and it is necessary for a diluent (e.g., water or other fluid) to be added

to liquify the solid, this process is called a reconstitution process. Alternatively and

as will be described in detail below, the medication can already be prepared and

therefore, in this embodiment, the fluid transfer station is a station where a precise

amount of medication is simply aspirated or withdrawn from the vial 60 and delivered to the syringe 10.

For purpose of illustration, the reconstitution process is first

described. After having been cleaned, the vial 60 containing a prescribed amount of

solid medication is delivered in the upright position to the fluid transfer station 570

by the device 530 as shown in Fig. 14. As will be appreciated, the device 530 has a

wide range of movements in the x, y and z directions and therefore, the vial 60 can easily be moved to a set fluid transfer position. At this position, the vial 60 remains

upright and a fluid transfer device 580 is brought into position relative to the vial 60

so that a fluid transfer can result therebetween. More specifically, the fluid transfer

device 580 is the main means for both discharging a precise amount of diluent into the vial 60 to reconstitute the medication and also for aspirating or withdrawing the

reconstituted medication from the vial 60 in a precise, prescribed amount. The

device 580 is a controllable device that is operatively connected to a control unit, such as a computer, which drives the device 580 to specific locations at selected

times. The control unit can be a personal computer that runs one or more programs

to ensure the coordinated operation of all of the components of the system 100.

As illustrated in Figs. 2 and 9-20, one exemplary fluid transfer device

580 includes a vertical base section 582 that is rotatably mounted to a base 584 so

that the device 580 can rotate between the fluid transfer position to the rotary device

130 where the medication is discharged into the syringes 10. The base 584 can be

mounted so that it can move in both the x and y directions. Near a distal end of the

base 584, a rotatable cannula unit 590 is operatively and rotatably coupled to the

base 584 to permit the cannula unit 590 a degree of rotation relative to the base 584.

For example, the cannula unit 590 can include a vertical housing 592 that is

rotatably coupled to the base 584 between the ends thereof. At an upper end 594 of

the housing 592, a cannula housing 600 is operatively coupled thereto such that the

cannula housing 600 can be independently moved in a controlled up and down

manner so to either lower it or raise it relative to the vial 60 in the fluid transfer

position. For example, the cannula housing 600 can be pneumatically operated and

therefore can includes a plurality of shafts 602 which support the cannula housing

600 and extend into an interior of the vertical housing 592 such that when the device

is pneumatically operated, the shafts 602 can be driven either out of or into the housing 592 resulting in the cannula housing 600 either being raised or lowered,

respectively, as shown in Figs. 14 and 15.

At one end of the cannula housing 600 opposite the end that is

coupled to the vertical housing 592, the cannula housing 600 includes a cannula

610. The cannula 610 has one end 612 that serves to pierce the septum of the vial 60 and an opposite end 614 that is connected to a main conduit 620 that serves to

both deliver diluent to the cannula 610 and ultimately to the vial 60 and receive aspirated medication from the vial 60. Preferably, the cannula 610 is of the type

that is known as a vented cannula which is vented to atmosphere as a means for

eliminating any dripping or spattering of the medication during an aspiration

process. More specifically, the use of a vented needle to add (and withdraw) the

fluid to the vial overcomes a number of shortcoming associated with cannula fluid

transfer and in particular, the use of this type of needle prevents backpressure in the

vial (which can result in blow out or spitting or spraying of the fluid through the

piercing hole of the cannula). The venting takes place via an atmospheric vent that is located in a clean air space and is formed in a specially designed hub that is

disposed over the needle. By varying the depth that the needle penetrates the vial,

the user can control whether the vent is activated or not. It will be appreciated that

the venting action is a form of drip control (spitting) that may otherwise take place. Moreover, the cannula 610 is also preferably of the type that is

motorized so that the tip of the cannula 610 can move around within the vial 60 so

that cannula 610 can locate and aspirate every last drop of the medication. In other

words, the cannula 610 itself is mounted within the cannula unit 590 so that it can

move slightly therein such that the tip moves within the vial and can be brought into contact with the medication wherever the medication may lie within the vial 60.

Thus, the cannula 610 is driven so that it can be moved at least laterally within the

vial 60.

An opposite end of the main conduit 620 is connected to a fluid pump system 630 that provides the means for creating a negative pressure in the main conduit 620 to cause a precise amount of fluid to be withdrawn into the cannula 610

and the main conduit 620 as well as creating a positive pressure in the main conduit

620 to discharge the fluid (either diluent or medication) that is stored in the main

conduit 620 proximate the cannula 610. In the illustrated embodiment, the fluid

pump system 630 includes a first syringe 632 and a second syringe 634, each of

which has a plunger or the like 638 which serves to draw fluid into the syringe or

expel fluid therefrom. The main difference between the first and second syringes

632, 634 is that the amount of fluid that each can hold. In other words, the first

syringe 632 has a larger diameter barrel and therefore has increased holding

capacity relative to the second syringe 634. As will be described in detail below, the first syringe 632 is intended to receive and discharge larger volumes of fluid,

while the second syringe 634 performs more of a fine tuning operation in that it

precisely can receive and discharge small volumes of fluid.

The syringes 632, 634 are typically mounted so that an open end 636 thereof is the uppermost portion of the syringe and the plunger 638 is disposed so

that it is the lowermost portion of the syringe. Each of the syringes 632, 634 is

operatively connected to a syringe driver, generally indicated at 640, which serves

to precisely control the movement of the plunger 638 and thus precisely controls the

amount (volume) of fluid that is either received or discharged therefrom. More

specifically, the driver 640 is mechanically linked to the plunger 638 so that

controlled actuation thereof causes precise movements of the plunger 638 relative to

the barrel of the syringe. In one embodiment, the driver 640 is a stepper motor that

can precisely control the distance that the plunger 638 is extended or retracted,

which in turn corresponds to a precise volume of fluid being aspirated or discharged. Thus, each syringe 632, 634 has its own driver 640 so that the

corresponding plunger 638 thereof can be precisely controlled and this permits the

larger syringe 632 to handle large volumes of fluid, while the smaller syringe 634 handles smaller volumes of fluid. As is known, stepper motors can be controlled

with a great degree of precision so that the stepper motor can be only be driven a

small number of steps which corresponds to the plunger 638 being moves a very

small distance. On the other hand, the stepper motor can be driven a large number

of steps which results in the plunger 638 being moved a much greater distance. The

drivers 640 are preferably a part of a larger automated system that is in

communication with a master controller that serves to monitor and control the

operation of the various components. For example, the master controller calculates

the amount of fluid that is to be either discharged from or aspirated into the cannula

610 and the main conduit 620 and then determines the volume ratio as to how much

fluid is to be associated with the first syringe 632 and how much fluid is to be

associated with the second syringe 634. Based on these calculations and

determinations, the controller instructs the drivers 640 to operate in a prescribed

manner to ensure that the precise amount of volume of fluid is either discharged or

aspirated into the main conduit 620 through the cannula 610.

The open end 636 of each syringe 632, 634 includes one or more

connectors to fluidly couple the syringe 632, 634 with a source 650 of diluent and with the main conduit 620. In the illustrated embodiment, the first syringe 632

includes a first T connector 660 that is coupled to the open end 636 and the second

syringe 634 includes a second T connector 662 that is coupled to the open end 636

thereof. Each of the legs of the T connectors 660, 662 has an internal valve mechanism or the like 670 that is associated therewith so that each leg as well as the

main body that leads to the syringe itself can either be open or closed and this action

and setting is independent from the action at the other two conduit members of the

connector. In other words and according to one preferred arrangement, the valve 670 is an internal valve assembly contained within the T connector body itself such

that there is a separate valve element for each leg as well as a separate valve

element for the main body. It will be appreciated that each of the legs and the main

body defines a conduit section and therefore, it is desirable to be able to selectively permit or prevent flow of fluid in a particular conduit section.

In the illustrated embodiment, a first leg 661 of the first T connector

660 is connected to a first conduit 656 that is connected at its other end to the

diluent source 650 and the second leg 663 of the first T connector 660 is connected

to a connector conduit (tubing) 652 that is connected at its other end to the first leg

of the second T connector 662 associated with the second syringe 634. A main body 665 of the first T connector 660 is mated with the open end 636 of the first

syringe 632 and defines a flow path thereto. The connector conduit 652 thus serves to fluidly connect the first and second syringes 632, 634. As previously mentioned,

the valve mechanism 670 is preferably of the type that includes three independently

operable valve elements with one associated with one leg 661, one associated with

the other leg 663 and one associated with the main body 665.

With respect to the second T connector 662, a first leg 667 is

connected to the connector conduit 652 and a second leg 669 is connected to a second conduit 658 that is connected to the main conduit 620 or can actually be

simply one end of the main conduit. A main body 671 of the second T connector 662 is mated with the open end 636 of the second syringe 634. As with the first T

connector 660, the second T connector 662 includes an internal valve mechanism

670 that is preferably of the type that includes three independently operable valve

elements with one associated with one leg 667, one associated with the other leg 669

and one associated with the main body 671.

The operation of the fluid pump system 630 is now described with

reference to Figs. 10-13. If the operation to be performed is a reconstitution

operation, the valve 670 associated with the second leg 669 is first closed so that the communication between the syringes and the main conduit 620 is restricted. The

valve element 670 associated with first leg 661 of the T connector 660 is left open

so that a prescribed amount of diluent can be received from the source 650. The valve element associated with the second leg 663 of the T connector 660 is initially

closed so that the diluent from the diluent source 650 is initially drawn into the first

syringe 630 and the valve element associated with the main body 665 is left open so

that the diluent can flow into the first syringe 632. The driver 640 associated with

the first syringe 632 is then actuated for a prescribed period of time resulting in the

plunger 638 thereof being extended a prescribed distance. As previously

mentioned, the distance that the driver 640 moves the corresponding plunger 638 is

directly tied to the amount of fluid that is to be received within the syringe 632. The extension of the plunger 638 creates negative pressure in the first syringe 632,

thereby causing diluent to be drawn therein. This is shown in Fig. 10.

Once the prescribed amount of fluid is received in the first syringe

632, the valve element associated with the main body 665 of the T connector 660 is

closed and the valve element associated with the second leg 663 is open, thereby permitting flow from the first T connector 660 to the second T connector 662 as

shown in Fig. 11. At the same time, the valve element associated with the first leg 667 and the main body 671 of the second T connector 662 are opened (with the

valve element associated with the second leg 669 being kept closed).

The driver 640 associated with the second syringe 634 is then

actuated for a prescribed period of time resulting in the plunger 638 thereof being

extended a prescribed distance which results in a precise, prescribed amount of fluid

being drawn into the second syringe 634. The extension of the plunger 638 creates

negative pressure within the barrel of the second syringe 634 and since the second T

connector 662 is in fluid communication with the diluent source 650 through the

first T connector 660 and the connector conduit 652, diluent can be drawn directly

into the second syringe 632. The diluent is not drawn into the first syringe 660 since the valve element associated with the main body 665 of the first T connector

660 is closed.

Thus, at this time, the first and second syringes 632, 634 hold in total

at least a prescribed volume of diluent that corresponds to at least the precise

volume that is to be discharged through the cannula 610 into the vial 60 to

reconstitute the medication contained therein.

It will be understood that all of the conduits, including those leading

from the source 650 and to the cannula are fully primed with diluent prior to

performing any of the above operations.

To discharge the prescribed volume of diluent into the vial, the process is essentially reversed with the valve 670 associated with the first leg 661 of

the T connector 660 is closed to prevent flow through the first conduit 656 from the diluent source 650. The valve element associated with the second leg 669 of the

second T connector 662 is opened to permit fluid flow therethrough and into the

second conduit 658 to the cannula 610. The diluent that is stored in the first and

second syringes 632, 634 can be delivered to the second conduit 658 in a prescribed volume according to any number of different methods, including discharging the

diluent from one of the syringes 632, 634 or discharging the diluent from both of

the syringes 634. For purpose of illustration only, it is described that the diluent is

drawn from both of the syringes 632, 634. This arrangement is shown in Fig. 12.

The diluent contained in the first syringe 632 can be introduced into the main conduit 620 by opening the valve associated with the second leg 663 and

the main body 665 of the first T connector 660 as well as opening up the valve

element associated with the first leg 667 of the second T connector 662, while the

valve element associated with the main body 671 of the second T connector 662 remains closed. The valve element associated with the second leg 669 remains

open. The driver 640 associated with the first syringe 632 is operated to retract the

plunger 638 causing a positive pressure to be exerted and resulting in a volume of

the stored diluent being discharged from the first syringe 632 into the connector conduit 652 and ultimately to the second conduit 658 which is in direct fluid

communication with the cannula 610. The entire volume of diluent that is needed

for the reconstitution can be taken from the first syringe 632 or else a portion of the

diluent is taken therefrom with an additional amount (fine tuning) to be taken from

the second syringe 634.

When it is desired to withdraw diluent from the second syringe 634,

the valve associated with the first leg 667 of the second T connector 662 is closed (thereby preventing fluid communication between the syringes 632, 634) and the valve associated with the main body 671 of the second T connector 662 is opened as

shown in Fig. 13. The driver 640 associated with the second syringe 634 is then

instructed to retract the plunger 638 causing a positive pressure to be exerted and

resulting in the stored diluent being discharged from the second syringe 634 into the second conduit 658. Since the second conduit 658 and the main conduit 620 are

fully primed, any new volume of diluent that is added to the second conduit 658 by

one or both of the first and second syringes 632, 634 is discharged at the other end

of the main conduit 620. The net result is that the prescribed amount of diluent that

is needed to properly reconstitute the medication is delivered through the cannula

610 and into the vial 60. These processing steps are generally shown in Figs. 14-16 in which the cannula 610 pierces the septum of the vial and then delivers the diluent

to the vial and then the cannula unit 590 and the vial gripper device 530 are inverted

to cause agitation and mixing of the contents of the vial.

It will be understood that in some applications, only one of the first

and second syringes 632, 634 may be needed to operate to first receive diluent from

the diluent source 650 and then discharge the diluent into the main conduit 610.

After the medication in the vial 60 has been reconstituted as by

inversion of the vial and mixing, as described herein, the fluid pump system 630 is

then operated so that a prescribed amount of medication is aspirated or otherwise

drawn from the vial 60 through the cannula 610 and into the main conduit 620 as shown in Figs. 16-20. Before the fluid is aspirated into the main conduit 620, an air

bubble is introduced into the main conduit 620 to serve as a buffer between the diluent contained in the conduit 620 to be discharged into one vial and the aspirated medication that is to be delivered and discharged into one syringe 10. It will be

appreciated that the two fluids (diluent and prepared medication) can not be allowed

to mix together in the conduit 620. The air bubble serves as an air cap in the tubing

of the cannula and serves as an air block used between the fluid in the line (diluent)

and the pulled medication. According to one exemplary embodiment, the air block

is a 1/10 ml air block; however, this volume is merely exemplary and the size of the air block can be varied.

The aspiration operation is essentially the opposite of the above

operation where the diluent is discharged into the vial 60. More specifically, the ,

valve 670 associated with the first leg 661 of the first T connector 660 is closed and the valve associated with the second leg 669 of the second T connector 662 is

opened to permit flow of the diluent in the main conduit into one or both of the

syringes 632, 634. As previously mentioned, the second syringe 634 acts more as a

means to fine tune the volume of the fluid that is either to be discharged or aspirated.

The drivers 640 associated with one or both of the first and second

syringes 632, 634 are actuated for a prescribed period of time resulting in the

plungers 638 thereof being extended a prescribed distance (which can be different from one another). As previously mentioned, the distance that the drivers 640 move

the corresponding plungers 638 is directly tied to the volume of fluid that is to be

received within the corresponding syringe 632, 634. By extending one or both of

the plungers 638 by means of the drivers 640, a negative pressure is created in the

main conduit 620 as fluid is drawn into one or both of the syringes 632, 634. The

creation of negative pressure within the main conduit 620 and the presence of the tip end of the cannula 610 within the medication translates into the medication being ^" drawn into the cannula 610 and ultimately into the main conduit 620 with the air

block being present therein to separate the pulled medication and the fluid in the line.

It will be appreciated that the aspiration process can be conducted so

that fluid is aspirated into one of the syringes 632, 634 first and then later an

additional amount of fluid can be aspirated into the other syringe 632, 634 by simply

controlling whether the valves in the main bodies 665, 671 are open or closed. For

example, if fluid is to be aspirated solely to the first syringe 632, then the valve

elements associated with the first and second legs 667, 669 of the second T connector 662 and the valve element associated with the second leg 663 and main

body 665 of the first T connector 660 are all open, while the valve elements

associated with the first leg 661 of the T connector 660 and the main body 671 of

the T connector 662 remain closed. After a sufficient volume of fluid has been

aspirated into the first syringe 632 and it is desired to aspirate more fluid into the

second syringe 634, then the valve element associated with the first leg 667 simply

needs to be closed and then the driver 640 of the second syringe 634 is actuated to

extend the plunger 638.

After aspirating the medication into the main conduit 620, the fluid

transfer device 580 is rotated as is described below to position the cannula 610 relative to one syringe 10 that is nested within the rotary dial 130 as shown in Figs.

19 and 20. Since the plungers 638 are pulled a prescribed distance that directly

translates into a predetermined amount of medication being drawn into the main

conduit 620, the plungers 638 are simply retracted (moved in the opposite direction) the same distance which results in a positive pressure being exerted on the fluid

within the main conduit 620 and this causes the pulled medication to be discharged

through the cannula 610 and into the syringe 10. During the aspiration operation

and the subsequent discharge of the fluid, the valves are maintained at set positions

so that the fluid can be discharged from the first and second syringes 632, 634. As

the plungers 638 are retracted and the pulled medication is discharged, the air block

continuously moves within the main conduit 620 toward the cannula 610. When all

of the pulled (aspirated) medication is discharged, the air block is positioned at the

end of the main conduit signifying that the complete pulled medication dose has been discharged; however, none of the diluent that is stored within the main conduit

620 is discharged into the syringe 10 since the fluid transfer device 580, and more

particularly, the drivers 640 thereof, operates with such precision that only the

prescribed medication that has been previously pulled into the main conduit 620 is

discharged into the vial 60. The valve elements can be arranged so that the plungers can be retracted one at a time with only one valve element associated with the main

bodies 665, 671 being open or the plungers can be operated at the same time.

It will be appreciated that the fluid transfer device 580 may need to make several aspirations and discharges of the medication into the vial 60 in order

to inject the complete prescribed medication dosage into the vial 60. In other

words, the cannula unit 590 can operate to first aspirate a prescribed amount of fluid

into the main conduit 620 and then is operated so that it rotates over to and above

one syringe 10 on the rotary dial 130, where one incremental dose amount is

discharged into the vial 60. After the first incremental dose amount is completely

discharged into the syringe 10, the vertical base section 582 is rotated so that the cannula unit 590 is brought back the fluid transfer position where the fluid transfer

device 582 is operated so that a second incremental dose amount is aspirated into the

main conduit 620 in the manner described in detail hereinbefore. The vertical base

section 582 is then rotated again so that the cannula unit 590 is brought back to the rotary dial 130 above the syringe 10 that contains the first incremental dose amount

of medication. The cannula 610 is then lowered so that the cannula tip is placed

within the interior of the syringe 10 and the cannula unit 590 (drivers 640) is

operated so that the second incremental dose amount is discharged into the syringe

10. The process is repeated until the complete medication dose is transferred into the syringe 10.

In yet another embodiment shown in Fig. 21, the two syringes 632,

634 are not directly connected to one another but instead each of the syringes 632,

634 is directly fluidly connected to the diluent source 550 and the main conduit 620.

More specifically, one leg of the T connector 660 of the first syringe 632 is coupled

to a first conduit 656 that is connected at its other end to the diluent source 650 and

the other leg of the connector 660 is coupled to a second conduit 658 that is

connected at its other end to the main conduit 620. Similarly, one leg of the T

connector 662 of the second syringe 634 is coupled to a first conduit 656 that is connected at its other end to the diluent source 650 and the other leg of the

connector 662 is coupled to a second conduit 658 that is connected at its other end to

the main conduit 620. In this manner, when it is desired to draw diluent from the

diluent source 650, the respective drivers 640 are operated to cause the respective

plungers 638 to be independently extended and depending upon the distance that

each is extended, a prescribed volume of diluent is drawn into the syringe. At this time, the valves 670 that are associated with the first conduits 658 are open, while

those associated with the second conduits 658 are clsoed. As mentioned, the first

syringe 632 typically draws a greater volume of diluent since the second syringe 634 is designed to fine tune and provide small increments of diluent to be added to the

vial. Similarly, when an aspiration process is performed, the two valves associated

with the first conduits 656 are closed and when the drivers 640 are operated to

discharge or pump the aspirated medication, the valves 670 associated with the first conduits 656 remain closed.

Once the syringe 10 receives the complete prescribed medication

dose, the vial 60 that is positioned at the fluid transfer position can either be (1) discarded or (2) it can be delivered to a holding station 700 where it is cataloged and

held for additional future use. More specifically, the holding station 700 serves as a

parking location where a vial that is not completely used can be used later in the

preparation of a downstream syringe 10. In other words, the vials 60 that are stored

at the holding station 700 are labeled as multi-use medications that can be reused.

These multi-use vials 60 are fully reconstituted so that at the time of the next use,

the medication is only aspirated from the vials 60 as opposed to having to first inject

diluent to reconstitute the medication. The user can easily input into the database of

the master controller which medications are multi-use medications and thus when

the vial 60 is scanned and identified prior to being delivered to the fluid transfer

position, the vial 60 is identified and marked as a multi-use medication and thus,

once the entire medication dose transfer has been performed, the vial gripper device

530 is instructed to deliver the vial 60 to the holding station 700. Typically, multi-

use medications are those medications that are more expensive than other medications and also are those medications that are used in larger volumes

(quantities) or are stored in larger containers and therefore come in large volumes.

The holding station 700 is simply a location where the multi-use vials

can be easily stored. For example, the holding station 700 is preferably a shelf or

even a cabinet that contains a flat surface for placing the vials 60. Preferably, there

is a means for categorizing and inventorying the vials 60 that are placed at the

holding station 700. For example, a grid with distinct coordinates can be created to make it easy to determine where each vial 60 is stored within the holding station

700.

Once the device 530 has positioned the gripper unit 540 at the proper

location of the holding station 700, the gripper unit 540 is operated so that the arms thereof release the vial 60 at the proper location. The device 530 then returns back

to its default position where it can then next be instructed to retrieve a new vial 60

from the pedestal 520.

If the vial 60 is not a multi-use medication, then the vial 60 at the

fluid transfer position is discarded. When this occurs, the device 530 moves such

that the vial 60 is positioned over a waste chute or receptacle and then the gripper

unit 540 is actuated to cause the vial 60 to drop therefrom into the waste chute or

receptacle. The device 530 then is ready to go and retrieve a new vial 60 that is

positioned at the pedestal 520 for purposes of either reconstituting the medication or

simply aspirating an amount of medication therefrom or a vial from the holding

station 700 can be retrieved.

As previously mentioned, during the reconstitution process, it is often

necessary or preferable to mix the medication beyond the mere inversion of the vial and therefore, the vial 60 can be further agitated using a mixing device or the like

710. In one embodiment, the mixing device 710 is a vortex type mixer that has a

top surface on which the vial 60 is placed and then upon actuation of the mixer, the vial 60 is vibrated or otherwise shaken to cause all of the solid medication to go into

solution or cause the medication to be otherwise mixed. In yet another embodiment,

the mixing device is a mechanical shaker device, such as those that are used to hold

and shake paint cans. For example, the vial 60 can be placed on support surface of

the shaker and then an adjustable hold down bar is manipulated so that it travels towards the vial and engages the vial at an end opposite the support surface. Once

the vial 60 is securely captured between these two members, the shaker device is

actuated resulting in the vial 60 being shaken to agitate the medication and ensure that all of the medication properly goes into solution. This type of mixing device

can also be configured so that it is in the form of a robotic arm that holds the vial by

means of gripper members (fingers) and is operatively connected to a motor or the

like which serves to rapidly move the arm in a back and forth manner to cause

mixing of the medication.

As briefly mentioned before, the entire system 100 is integrated and

automated and also utilizes a database for storing identifying data, mixing

instructions, and other information to assist in the preparation of the medication.

There are also a number of safety features and check locations to make sure that the medication preparation is proceeding as it should.

For example, the database includes identifying information so that

each vial 60 and syringe 10 can be carefully kept track of during each step of the

process. For example, a scanner 720 and the photoimaging equipment serve to positively identify the vial 60 that is delivered from the drug storage 110.

Typically, the user will enter one or more medication preparation orders where the

system 100 is instructed to prepare one or more syringes that contain specific

medication. Based on this entered information or on a stored medication

preparation order that is retrieved from a database, the vial master controller determines at which location in the cabinet the correct vial 60 is located. That vial

60 is then removed using a robotic gripper device (not shown) and is then placed on

the conveyor belt 111 and delivered to the mechanism 510 pivots upright so that the

vial 60 is moved a vertical position relative to the ground and is held in an upright manner and is then delivered to the rotatable pedestal 520. At the pedestal 520, the

vial 60 is scanned to attempt to positively identify the vial 60 and if the scanned

identifying information matches the stored information, the vial 60 is permitted to proceed to the next station. Otherwise, the vial 60 is discarded.

Once the vial 60 is confirmed to be the right vial it proceeds to the

fluid transfer position. The master controller serves to precisely calculate how the

fluid transfer operation is to be performed and then monitors the fluid transfer

operations has it is occurring. More specifically, the master controller first determines the steps necessary to undertake in order to perform the reconstitution

operation. Most often during a reconstitution operation, the vial 60 that is retrieved

from the drug storage 110 contains a certain amount of medication in the solid form.

In order to properly reconstitute the medication, it is necessary to know what the

desired concentration of the resulting medication is to be since this determines how

much diluent is to be added to the vial 60. Thus, one piece of information that the

user is initially asked to enter is the concentration of the medication that is to be delivered to the patient as well as the amount that is to be delivered. Based on the

desired concentration of the medication, the master controller is able to calculate

how much diluent is to be added to the solid medication in the vial 60 to fully

reconstitute the medication. Moreover, the database also preferably includes instructions as to the mixing process in that the mixing device is linked to and is in

communication with the master controller so that the time that the mixing device is

operated is stored in the database such that once the user inputs the medication that

is to be prepared and once the vial 60 is scanned and identified, the system (master

controller or CPU thereof) determines the correct of time that the vial 60 is to be

shaken to ensure that all of the medication goes into solution.

Once the master controller determines and instructs the working

components on how the reconstitution operation should proceed, the master

controller also calculates and prepares instructions on how many distinct fluid

transfers are necessary to deliver the prescribed amount of medication from the vial

60 to the syringe 10. In other words, the cannula unit 590 may not be able to fully

aspirate the total amount of medication from the vial 60 in one operation and

therefore, the master controller determines how many transfer are needed and also

the appropriate volume of each aspiration so that the sum of the aspiration amounts is equal to the amount of medication that is to be delivered to the syringe 10. Thus

when multiple aspiration/discharge steps are required, the master controller instructs

and controls the operation of the drivers 640 so that the precise amounts of

medication are aspirated and then discharged into the syringe 10. As previously

described, the syringe drivers 640 retract and advance at the right levels to cause the

proper dose amount of the medication to be first aspirated from the vial and then discharged into the syringe. This process is repeated as necessary until the correct dose amount is present in the syringe 10 in accordance with the initial inputted

instructions of the user.

After transferring the proper precise amount of medication to one

syringe 10, the master controller instructs the rotary dial to move forward in an

indexed manner so that the next empty syringe 10 is brought into the fluid transfer

position. The cannula 610 is also preferably cleaned after each medication dose

transfer is completed so as to permit the cannula 610 to be reused. There are a

number of different techniques that can be used to clean the cannula 610 between

each medication transfer operation. For example, the cleaning equipment and

techniques described in commonly assigned U.S. patent No. 6,616,771 and U.S.

patent application serial No. 10/457,898 (both of which are hereby incorporated by

reference in their entireties) are both suitable for use in the cleaning of the cannula

610. In one embodiment, the cannula 610 is rotated and positioned so that

the needle of the cannula 610 is lowered into a bath so that fluid is expelled between

the inside hubs of the syringe 10 for cleaning of the interior components of the

cannula 610. The cannula 610 is then preferably dipped into a bath or reservoir to

clean the outside of the cannula 610. In this manner, the cannula 610 can be fully

cleaned and ready for a next use without the need for replacement of the cannula

610, which can be quite a costly endeavor.

In yet another embodiment illustrated in Figs. 22-24, a medication source 730, such as a bag that is filled with liquid medication that has already been

properly reconstituted, is connected to an input portion of a peristaltic pump 732 by means of a first conduit section 740. A second conduit section 742 is connected to

an output port of the pump 732 and terminates in a connector 744. The connector 744 is of the type that is configured to hermetically seal with an open barrel tip of

the syringe 10 that is nested within the rotary dial 130 and is marked to receive

medication. The connector 744 typically includes a conduit member 745 (tubing)

that is surrounded by a skirt member or the like 747 that mates with the outer hub of

the syringe barrel. A flange or diaphragm 749 can be provided as shown in Fig. 24

for hermetically sealing with the syringe barrel (outer hub).

In commonly assigned U.S. patent application serial No. 10/457,066

(which is hereby incorporated by reference in its entirety), it is described how the

plunger 50 of the syringe 10 can be extended with precision to a prescribed distance. In that application, the plunger 50 is extended to create a precise volume

in the barrel that is to receive the medication that is injected therein at a downstream

location. However, it will be appreciated that the action of extending the plunger 50

can serve more than this purpose since the extension of the plunger 50 creates

negative pressure within the syringe barrel and thus can serve to draw a fluid

therein. For example, once the connector 744 is sealingly mated with the open

syrmge tip end, the medication source 730 is fluidly connected to the syringe 10 and

thus can be drawn into the syringe barrel by means of the extension of the plunger 50. In other words, the plunger 50 is pulled a precise distance that results in the

correct size cavity being opened up in the barrel for receiving the fluid but also the

extension of the plunger creates enough negative pressure to cause the medication to

be drawn into the syringe barrel. This is thus an alternative means for withdrawing the proper amount of medication from a member (in this case the source 730) and transferring the desired, precise amount of medication to the syringe 10. The

operation of this alternative embodiment can be referred to as operating the system

in reservoir mode. One advantage of this embodiment is that multiple syringe drivers are not needed to pump the medication into the syringe 10 but rather the

drawing action is created right at the rotary dial 130. This design is thus fairly

simple; however, it is not suitable for instances where drug reconstitution is

necessary.

Prior to its using another drug, the cannula 610 is cleaned using

conventional techniques, such as those described in the previously incorporated

patents and patent applications.

After the medication is aspirated into the barrel 20, the dial 130 is

advanced so that the filled syringe 10 is delivered to the sixth station 180 (Fig. 2). For example, the dial 130 is preferably advanced so that the filled syringe 10 is

delivered to a station where the removed tip cap 40 is replaced back onto the barrel

tip 28 by a device 900. Referring to Figs. 25 and 26, the device 900 can be similar or identical to the device 300 that removes the tip cap 40 from the barrel tip 28 at an

earlier station or the device 900 can be different from the device 300 so long as the

device 900 is configured to grasp the tip cap 40 from the post 161 and then place the

tip cap 40 back on the barrel tip 28.

For purpose of illustration and simplicity, the device 900 will be

described as being of the same type as device 300. The automated device 900 is a robotic device and preferably, the automated device 900 is a linear actuator with a

gripper. The device 900 has a vertical base 910 which is adjustable in at least

several directions. For example, the vertical base 910 has an independent reach (y axis) and vertical axis (x axis) which provides part of the flexibility and motion

control that is desirable for the device 900. The vertical base 910 has an upper end

912 and an opposing lower end 914 which is operatively coupled to other movable

components to permit the vertical base 910 to move in an up/down direction along

the x axis and in lateral directions along the y axis. The upper end 912 is connected

to a horizontal support member 920 that extends outwardly away from the vertical

base 910. In one exemplary embodiment, the lower end 614 is disposed between

two support beams that are part of a robotic device and are moved in a number of

different directions, including along the x axis and the y axis.

A block member 930 is connected to the horizontal support member

920 and more specifically, the block member 930 is disposed on an underside of the

horizontal support member 920 so that it is spaced away from the vertical base 910.

The exemplary block member 930 has a block-like shape and is connected to the

underside of the horizontal support member 920 by one or more connectors that can

be in the form of support columns, etc.

The device 900 has first and second positionable gripping arms 940 which are adjustable in at least one direction and which are coupled to and extend

downwardly from the block member 930. For example, each of the gripping arms

940 is movable at least in a direction along the y axis which provides the flexibility

and motion control that is desirable in the present system 100. The gripping arms

940 are programmed to work together in tandem so that both arms 940 are driven to

the same location and the same time.

The block member 930 can house some of the electronic or hydraulic

components and the like that permit the gripping arms 940 to move between the open and closed positions. The coupling between the block member 930 and the

gripping arms 940 is such that the gripping arms 940 have the necessary degree of movement to permit the opening and closing thereof.

Each of the gripping arms 940 is a generally L-shaped member that is formed of a vertical section 942 and a horizontal gripping section (not shown) that

extends outwardly from one end of the vertical section 942. The gripping section

has a cut-out or notch 360 (Fig. 3) formed therein for receiving and gripping a

section of the barrel 20 of the syringe 10. Accordingly, the notch has a

complementary shape as the shape of the barrel 20. One exemplary notch has a

generally semi-circular shape and it seats against approximately Vi of the outer

circumferential surface of the syringe barrel 20. By being movable along at least

the y axis, the gripping arms 940 can be positioned between an open position in

which the opposing gripping sections of the arms 940 are spaced apart from one

another a sufficient distance to permit the tip cap 40 to be received therebetween. In the closed position, the gripping sections of the arms 940 are

brought together so that they either seat against one another or are in very close

proximity to one another. When the gripping sections come together in the closed position, the notches define a complete circular opening that has a diameter about

equal to or slightly less than the diameter of the base section 41 of the tip cap 40,

thereby permitting the tip cap 40 to nest within the gripping sections 944.

In a first open position of the gripping arms 940, the gripping

sections being spaced sufficiently from one another so as to permit the tip cap 40 to

be freely disposed between the gripping sections. Using a control unit 950 (e.g., a

programmable actuator, microprocessor, etc.), the gripping arms 940 are driven to the first position shown in Fig. 14. The control unit 950 instructs the device 900 to

perform an operation where the tip cap 40 resting on the post 161 is gripped and

removed by the device 900. When such an operation is performed, the vertical base

910 is driven inwardly toward the dial 130 and upwardly so that the gripping arms 940 are positioned over the tip cap 40 that is disposed on top of the post 161. The

vertical base 910 is then driven downward until the gripping arms 940 are disposed

around the tip cap 40. In other words, the tip cap 40 is disposed between the

gripping section of the opposing arms 940 and more specifically, the gripping sections 944 are disposed adjacent the base section 41 of the tip cap 40 underneath

the flange 43 with the notches being aligned with the outer surface of the base

section 41. An actuator or the like of the device 900 is then activated causing the

gripping arms 940 to move inwardly toward one another until the gripping sections

944 seat against the outer surface of the base section 41 of the tip cap 40.

Preferably, a hydraulic or pneumatic system can be used to move the gripping arms 940 between their relative positions. In this closed position, the gripping arms 940

apply a force against the base section 41 so that the tip cap 40 is securely held by

the gripping sections. When the gripping arms 940 are driven to the closed

position, the gripping sections may seat against one another and the notches align

such that the gripping sections substantially encircle the base section 41.

After the tip cap 40 is nested within the gripping sections, the control

unit 950 directs the vertical base 910 upward and this motion causes the tip cap 40

to be removed from the post 161. After the tip cap 40 is freed from the post 161, it

remains held between the gripping sections of the opposing arms 940. The vertical

base 910 is then driven in a direction away from the dial 130 until the held tip cap 40 is positioned over the barrel tip 28. Once the tip cap 40 is disposed over the

barrel tip 28 of the filled syringe 10, the controller 950 instructs the vertical base 910 to move downwardly so that the tip cap 40 is placed on the barrel tip 28 as

shown in Fig. 15. The actuator is then activated causing the gripping arms 940 to

move to the open position, thereby releasing the tip cap 40. The tip cap 40 is now

firmly secured back on the barrel tip 28. The device 900 then is returned to its

initial position, the dial 130 is advanced and the operation is repeated with the

device 900 gripping and replacing one tip cap 40 back on the next uncapped syringe 10 that is advanced to this station.

The capped syringe 10 can then be transferred to other stations, such

as a station where the syringe in bandolier form is cut into individual syringes 10

that are labeled for particular patients. The syringes 10 can then be unloaded from the dial 130 by manipulating the second retaining member 136 and more

specifically, the operable pivotable arms 143, 145, (Fig. 3) are opened after an

unloading gripper (not shown) grips the barrel 20 of the syringe 10 and withdraws it

from the dial 130. The syringe 10 is then further processed as for example by being

delivered to a storage receptacle where it is stored or by being delivered to a transporting device for delivery to the patient.

In yet another embodiment, a detection station 800 is provided, as

shown in Fig. 9, and serves as a vial orientation detector that is an automated means

for determining whether the vial 60 is in correct orientation throughout one or more

stages of the operation. For example, the detection station 800 includes a detector

or the like 810 which determines whether the vial is an upright position or is in the

opposite downright position. The orientation of the vial 60 is very important as the vial 60 is moved from one station to the next since if the vial 60 is orientated wrong,

this can lead to damage or destruction of certain components of the equipment.

According to one embodiment, one detector 810 is positioned near the pedestal 520

and it serves to detect the state of the vial 60 before it is introduced into the decapper station 550 since if the vial 60 is introduced in the wrong state, this will

possibly lead to damaging the decapper equipment and certainly will not result in the

vial cap being removed. Typically and during a normal operation, the vial 60 stands

upright on the pedestal 520 and then the vial gripper device 530 grips and inverts

the vial 60 as it delivers it to the decapper station 550. Thus, the detector 810 can

be configured to either detect the vial 60 being in the proper upright position on the

pedestal 520 or it can detect the vial 60 being inverted after it has been removed

from the pedestal 520.

There are a number of different types of detectors 810 that are

suitable for use in the present application so long as the detector 810 functions in the

aforementioned manner. For example, the detector 810 can be of the type that reads

a marker or detects the absence thereof that is placed on the vial 60. In one

embodiment shown in Fig. 33, the vial 60 includes a small metal chip or metal ring

or the like 811 (magnetic element) that is coupled to the top (or bottom) of the vial

60 and the presence or absence thereof is detected by the detector 810. In this

arrangement, the detector 810 can be of the type that detects the presence or

variation in a surrounding magnetic field and therefore, if the vial 60 passes the detector 810 and the metal element 811 passes by the detector, the detector 810

detects and records the change in the magnetic field. This detection can trigger a

signal being generated which indicates that either the vial 60 is correctly orientated or is improperly orientated and any necessary action can be taken therefrom. For

example, if the magnetic element 811 is placed at or near the top of the vial 60 and

the detector 810 is positioned near the pedestal 520, the detector 810 detects a

change in magnetic field since the vial 60 is properly upright on the pedestal 520

and the detector can send a signal to the master controller to indicate the proper

orientation of the vial 60 and therefore, the vial 60 should be engaged by the vial

gripper device 530 and moved to the next station. If the detector 810 does not

detect a change in the magnetic field, then the vial 60 is removed from the pedestal

520 by any number of different mechanisms, e.g. , a sweeper blade can swipe across the pedestal 520 and direct the vial 60 into some type of collection receptacle.

Similarly, the detector 810 can operate in the same manner further

downstream in the system. For example, it is very important that the vial 60 be

properly orientated at the fluid transfer station since if the vial 60 is inadvertently upside down (inverted) then the automated cannula 610 will be directed down and

will strike the hard bottom of the vial 60 as opposed to the soft, pierceable septum

that is formed at the other end for permitting selective communication with the

inside of the vial 60. This action will likely result in severe damage or total destruction of the tip end of the cannula 610. The cannula unit itself can be very

costly and thus, it is desirable to have a detector means associated upstream or at the

fluid transfer station to ensure that the vial 60 is in its proper upright position. If

the detector fails to detect that the vial 60 is in the desired upright position, then the

cannula unit 590 is not activated and the vial gripper device 530 is instructed to bring the held vial 60 to a station where it is discarded into a collection receptacle and the process is started over again resulting in the vial gripper device 530 moving to a default position.

While the above described detector 810 reads and detects changes in

magnetic fields, any number of other types of detectors can be used. For example

and according to the embodiment shown in Fig. 34, the detector 810 can be an optical reader that detects the presence or absence of an optical marker 813 (ring

shaped optically detectable member) that is formed on the vial 60. Once the

detector 810 reads or after a period of time passes in which the detector 810 does not detect the marker, then an appropriate signal is generated and delivered to the

master controller that in turn controls the advancement or discarding of the syringe

10. It will be appreciated that there are other types of detectors 810 that can be

incorporated into the present invention for the purpose of detecting the orientation of

the vial 60. For example, the detector 810 can be a reader and the vial 60 can

include a scannable tag that is attached thereto at one location. The detector 810

continuously reads as by emitting a beam or the like and once and if the scannable

tag passes through the beam, the detector reads the tag and generates a control

signal indicating that the vial is in the proper orientation and should be advanced to

the next station. In other words, the information encoded on the scannable tag is

not important but what is important is that the detector only can read this

information and take affirmative action, such as generating to the control signal,

when the vial is in the proper orientation. If the vial is not in its proper orientation,

then the scannable tag will not pass through the beam and no control signal is generated and thereby, the vial 60 is not advanced to the next station. It will also be appreciated that the location of the detector 810 can be

varied and the above described locations are merely exemplary in nature and not

limiting of the present invention. The detector 810 is preferably located at any

position where it is desirable for the position (orientation) of the vial 60 to be

determined and monitored. However, preferred locations include those previously

described where the vial 60 is about to be introduced to a station where an operation is to be performed on the vial 60.

Preferably, the automated system includes at least one additional

station, namely station 197 at which the tip cap 40 is made tamper proof or more

precisely it is made tamper evident. More specifically, station 197 is designed as a

station where an operation is performed on the tip cap 40 so that the tip cap 40 is

made tamper evident by adding a tamper evident feature to the tip cap 40 that

permits a consumer or user to easily determine whether the tip cap 40 has been

tampered with and therefore warranting the discarding of the syringe 10. There are

a number of different types of tamper evident operations that can be performed at station 197 so long as the result is that the tip cap 40 is made tamper evident. The

operations discussed below are merely exemplary and illustrative and in no way

limit the present invention in terms of which types of tamper evident operations can be performed.

In one exemplary embodiment and as illustrated in Figs. 2 and 29-30,

station 197 is a heat-staking station where a device is provided to perform a heat-

staking operation on the tip cap 40. Heat-staking makes use of direct contact-heated

tools and precisely controlled time, temperature, pressure and cooling to reform

plastic studs, walls and protrusions. The heat-staking device includes a tool that is used to produce the heat-stake (local weld) between the flange of the tip cap 40 and

the underlying portion of the syringe 10, namely the barrel tip 28 (outer hub of the

leur assembly). The heat-stake between the tip cap 40 and the outer hub is in the

form of a localized area where the two plastic parts are joined together (e.g., a

small localized welded spot) (e.g., see Fig. 36). As mentioned, the time,

temperature, pressure and cooling steps of the heat-staking operation are closely

monitored and controlled so that the desired result is obtained as opposed to a

situation where a localized welded spot is not formed between the two parts. For

example, if the temperature of the heat-staking operation is not hot enough, the heat

from the tool will not penetrate deep enough through the tip cap 40 and into the barrel tip (outer hub) and this results in no spot weld being formed between the two

plastic parts. Conversely, if the temperature is too hot, the heat from the tool will

penetrate the barrel tip (outer hub) resulting in a hole or other imperfection being

formed in the barrel tip and this can lead to contamination or otherwise results in the

syringe 10 being unfit for use. Thus, it is important that the position, temperature,

etc. of the tool be controlled to ensure that the desired small heat-stake be formed

between the two plastic parts.

The tool can be in the form of a heated probe, hot nail, solder iron

tip, etc., so long as it is designed as a tool that is intended for use in a heat-staking

process to produce a heat-stake between the two plastic parts. Preferably, the

syringe 10 is held tightly in place when the heat-staking operation is performed so

that when the tool makes contact with the outer surface of the tip cap 40, the syringe 10 does not move. For example, an automated gripper can be driven into place to

grasp and hold the syringe 10 in place, while the tool is then moved into place and into contact with the outer surface of the tip cap 40. The gripper can thus include

gripper fingers or otherwise have a contoured slot that receives the syringe 10 such

that the movement of the syringe 10 is restricted.

The heat-stake serves to make the tip cap 40 tamper evident since the user will feel noticeable resistance and notice a pronounced "snap" when the tip cap

40 is twisted from the syringe when the user is attempting to remove the tip cap 40

prior to using the syringe 10. This "snap" signals that the syringe 10 is intact and

has not been tampered with, or inadvertently has been after the cap has been removed and replaced after the syringe 10 was prepared. It will be appreciated that

the user needs to twist the tip cap 40 to a sufficient degree to overcome the strength

of the bond between the tip cap 40 and the syringe barrel in order to open the

syringe 10 and break the bond which is evidenced by the "snap" noise.

Figs. 37 and 38 illustrate in detail an exemplary heat staking

assembly 1100 that includes a controllable welding tip 1110 that performs the heat staking operation. The assembly includes a base mount 1102 that can be affixed to

a support surface, such as a floor, and a vertical standoff 1104 that extends

upwardly therefrom. A second end 1106 of the standoff 1104 is coupled to a actuator 1110 which extends outwardly therefrom. At one end of the actuator 1110

there is a mount 1112 that is driveable in that it can be extended and retracted

relative to a base portion of the actuator 1110. One exemplary actuator 1110 is in

the form of a pneumatic cylinder. At a distal end of the mount 1112, a heat stake

device 1120 is mounted thereto using conventional techniques, such as using one or

more fasteners. A mounting plate 1122 or the like can be used to mount the device

1120 to the mount 1112. The heat staking device 1120 is an elongated member that has a tip end 1124 that is heated and is used to produce the heat stake (e.g., spot weld) or the

like that is in the form previously mentioned. The device 1120 can be in the form

of any number of conventional heat staking devices. Preferably, the device 1120 is

pivotally mounted to the mount 1112 so that the device 1120 can be adjusted in at

least an up-down manner. In addition, a protective cover 1130 is preferably used to

cover the device 1120 so that an individual is shielded from the actual heat staking

operation that is performed at the tip end 1124. In other words, one end of the

protective cover 1130 extends beyond the tip end 1124 so that it can cover a syringe 10 that is placed into a position so that the heat staking operation can be performed.

The protective cover 1130 can be mounted to the mounting plate 1122.

Along a length of the vertical standoff 1104, a syringe holder 1140 is

provided for holding in place at least one syringe 10. The syringe holder 1140 is in

the form of a substrate that is movable relative to the standoff 1104. The syringe

holder 1140 can be provided above a collar 1150 that is formed around the standoff

1104. As shown in Fig. , the holder 1140 is a plate-like member that has a slightly

curved surface 1142 that seats against the barrel of the syringe 10 as the syringe 10

is moved into position for the heat staking operation to be performed. For example, the syringe 10 can be securely held by the rotary dial 130 that rotates in an indexed

manner and as described below, when the syringe 10 is moved into the heat staking

station 1100, the holder 1140 is extended so that the surface 1142 seats against the

barrel of the syringe with the syringe being securely held in position between the

holder 1140 and the rotary dial 130. Once the syringe is held in place, the heat staking assembly is

actuated to cause the heat stake device 1120 to be drawn in towards the syringe 10 so as to position the tip end 1124 in close proximate relation to the tip cap 40 of the

syringe. The device 1120 is drawn in towards the syringe 10 by retracting the

mount 1112 within the cylinder that forms a part of the actuator 1110. The working

components of the assembly are preferably all in communication with a master

controller that controls the movements of the working components and therefore,

when the assembly is actuated when a new syringe 10 is indexed forward into a heat

staking operation position, the actuator 1110 is operated to drive the heat stake

device 1120 into position such that the tip end 1124 is brought into contact with the

tip cap of the syringe 10 for a predetermined period of time and at a predetermined

pressure to form a welded heat stake of the type mentioned hereinbefore. After the

predetermined period of time has lapsed, the actuator 1110 is operated to cause the

mount 1112 to extend, thereby driving the tip end 1124 away from contact with the tip cap of the syringe. The process then continues by moving the rotary device

1130 in an indexed manner so that the completed heat staked syringe is removed

from the station 1100 and another syringe 10 is advanced into the station 1100. In

this embodiment, the station 1100 is one where a welding operation is performed.

In yet another embodiment and as illustrated in Figs. 35 and 36,

station 197 is a station where an ultrasonic welding operation is performed by an

ultrasonic welder 1010 or the like. Ultrasonic welding is a process used to join

plastic parts through pressure and high frequency mechanical vibrations, creating localized frictional heat that melts the plastic together. When the vibrations stop,

the plastic quickly cools and solidifies resulting in a localized spot weld between the two plastic parts, which in the present case is namely the tip cap 40 and the

underlying syringe part, e.g. , barrel tip luer connection 28. As is illustrated, the tip

cap 40 has a flange that extends down from a top cover portion and this annular

flange is the portion that extends around (circumscribes) the barrel tip luer

connection 28 when the tip cap 40 is properly secured to the barrel tip luer

connection 28 as by threads, snap-fit, etc. Accordingly, the spot weld is typically

located at some location along the flange of the tip cap 40. As mentioned, the

ultrasonic welder 1010 typically has a tool 1012 or the like which is placed into

contact with or in close proximity to an outer surface of the flange of the tip cap 40

and then a horn of the welder 1010 acts as an acoustic tool and transfers vibratory

energy directly to the parts being assembled (tip cap 40 and the syringe barrel) and it also applies a welding pressure. The vibrations are transmitted through the

workpiece to the joint area. Here the vibratory energy is converted to heat through

friction - this then softens or melts the plastic and joins the plastic parts together. It

will be appreciated that the welding operation can be repeated and more than one

localized weld spot can be created around the periphery of the tip cap 40.

Since ultrasonic welding is very fast (weld times are typically less

than 1 second) and easily automated, it is particularly suited for use in the present

system 100 for the purpose of creating a tamper proof tip cap 40. As with the heat-

staking operation, the ultrasonic welding operation produces a small area of bonding

between the tip cap 40 and the syringe barrel 28 such that when the user twists the

tip cap 40, the user should feel noticeable resistance and hear a "snap" noise that

evidences that the two plastic parts are bonded together and have not been tampered

with since the bonding operation was performed. In yet another embodiment illustrated in Figs. 39-45, the tamper

evident processing station can include an automated tip taper device which is configured to place tamper evident tape over the end of the syringe. In other words,

the automated device disposes and affixes one end of the tamper evident tape to an

outer surface of the syringe barrel and then wraps the tape over and on top of the tip

cap 40 before affixing the other end of the tape to the other side of the syringe

barrel. The tape should be tightly fit across the tip cap so that it is under an amount

of tension when it is placed on and over the tip cap so that any type of twisting or

removal or attempted removal of the tip cap will result in the tape being damaged in

some way. In other words, by viewing the appearance and integrity of the tamper

evident tape, the user can tell if the syringe 10 has been or may have been tampered

with and therefore should not be used but rather should be discarded.

Figs. 39-42 illustrate one device that is capable of producing a tamper

evident syringe. More specifically, a tamper evident tape sealing station 1200 is

provided for applying a section of tape over the tip cap of the syringe, with the ends

of the tape being affixed to the syringe barrel as shown in Fig. 37. The station 1200

includes an assembly 1210 for applying a tamper tape 1212 about the tip cap 40 of

the syringe 10. The assembly 1210 has a base 1214 with a standoff 1216 extending

upwardly therefrom. Formed along a length of the standoff 1216 are a collar 1218,

a moveable syringe slide 1220, and a cutting mechanism 1222 for selectively cutting

the tape. The tape 1212 is initially provided in a roll form with the tape 1212 being wound about a core 1224 that is mounted on a cylinder mount 1226. The tape 1212

is fed from the roll to a tape guide mechanism 1230. The tape guide mechanism

1230 includes a roller 1232 and tape guide 1234 that receives the tape 1212 from the roller 1232 and feeds into down to an applicator device. A tape guide rod 1236 is

provided and runs the length of the tape guide 1234. A tape wipe plate 1240

includes a first roller 1242 and a second roller 1244 along with a cap roller 1246.

The tape 1212 is fed down the tape guide 1234 in an indexed fashion to one of the

rollers 1242, 1244 which applies pressure to the tape 1212 and presses the tape into

contact with one side of the syringe barrel so as to securely attach the tape thereto

and then by action of the applicator mechanism, the tape is then applied across the

top of the tip cap 40 by means of the cap roller 1246 which attaches the tape

thereacross and then the roller applies the tape to the other side of the barrel.

The syringes 10 are received from the rotary device 130 and the

syringe slide 1220 serves to apply pressure to the syringes that are held in the

pockets of the rotary device 130 so that the syringes do not move during the

application of the tape. After the tape is applied to one cap, an index arm 1250 will

go to idle position and the tape is cut at next start and the index arm will come down

and start taping the next syringe (Figs. 41 and 42). If there is no syringe, the dial

finger (part of dial 130) will index the tape arm to the first syringe and start taping

on barrel. The tape will make contact in idle index mode.

Figs. 43-44 illustrate in close up a tamper tape secondary wipe

assembly 1300. The assembly 1300 includes an output cutter top plate 1310 that has an opening formed therethrough for receiving a shaft 1312 that is coupled to a

bandolier wipe clevis 1320 that is generally a U-shaped member. A bandolier front

wipe 1322 and bandolier rear wipe 1324 are held between the bandolier wipe clevis

1320 in a pivotable manner. More specifically, first ends of the wipes 1322, 1324

are pivotably coupled to the clevis 1320 by a pin 1326 with springs 1328 being disposed between each side face of the wipes 1322, 1324 and the facing wall of the clevis 1320. A bandolier wipe top stop 1330 and bandolier wipe stop 1332 are also provided. The wipe assembly 1300 is designed to apply pressure to the tape to

ensure that the tape is securely fixed to the bandolier ed syringe.

Fig. 46 illustrates another means for providing a tamper evident

syringe. More specifically, the prepared syringe 10 is disposed within a plastic

body 1350 and then sealed (e.g., as by heat) to provide another tamper proof

evident solution. In other words, the syringe lies between two sheets of plastic

material and a first seal (e.g., heat seal) 1352 is formed across the sheets and then a

second seal 1354 is formed across the plastic material with the syringe 10 disposed between the seals 1352, 1354. The body 1350 is otherwise joined along its sides so

that the result of the sealing action is that a sealed bag 1350 is formed. A perforated

line 1360 is formed in the bag 1350 near one of the seals 1352, 1354 to permit the

bag to be opened. The plastic bag 1350 is formed such that it is free of electrostatic

charges.

The user can easily see if the syringe 10 has been tampered with by

simply observing the condition of the bag 1350. If the bag 1350 is not in a

completely sealed condition, the user should not use the syringe 10 as it should be

treated as being tampered with. It will further be appreciated that conventional

shrink wrapping techniques can be used as a means for providing a tamper evident proof solution for the distribution of syringes.

It will be appreciated by persons skilled in the art that the present

invention is not limited to the embodiments described thus far with reference to the accompanying drawings; rather the present invention is limited only by the

following claims.

Claims

What is claimed is:

1. An automated medication preparation system including

automated syringe preparation including reconstitution of the medication, the system

comprising:

a first automated gripping means for removing a tip cap from a barrel

of one syringe and placing the removed tip cap at a first location;

an automated device for delivering a prescribed dosage amount of

medication to the syringe by delivering the medication through the uncapped barrel in a just-in-time for use manner;

a controller in communication with the automated device and

including a database for storing reconstitution information that is executable with the

automated device for reconstituting the medication prior to it being injected into the

syringe, wherein the reconstitution information include at least a concentration of

the resultant medication and a mixing time for agitating the medication; and

a second automated gripping means for replacing the removed tip cap

on the syringe barrel after the medication is injected therein.

2. The automated system of claim 1, wherein each of the first

and second automated gripping means comprises a robotic device having first and

second gripping arms that are spaced apart from one another in a first position and are moved toward one another to a second position so as to securely capture and

hold the tip cap between the first and second gripping arms.

3. The automated system of claim 2, wherein the robotic device is movable at least along an x axis and a y axis.

4. The automated system of claim 1, further including:

an automated device for extending a plunger of the syringe barrel.

5. The automated system of claim 4, wherein the automated

device is operatively connected to a control unit which instructs the automated

device to extend the plunger a predetermined distance based on the prescribed

amount of medication.

6. The automated system of claim 1, further including an

automated rotary device that is indexed to advance the syringe from one station to another station, the rotary device having a first feature formed as part thereof for

releasably retaining the syringe and a second feature for holding the removed tip cap

as the syringe is advanced from one station to the next.

7. The automated system of claim 1, wherein the automated device for delivering a prescribed dosage amount of medication to the syringe

comprises an automated robotic device that operates in accordance with signals

received from the controller and includes a cannula unit that is rotatably mounted to a vertical base which is itself rotatably mounted to a lower ground base, wherein the cannula unit includes a cannula extending thereaway for performing at least one of

the following operations: (1) receiving and discharging diluent from a diluent supply

in a prescribed amount to reconstitute the medication in a vial; and (2) aspirating

and later discharging reconstituted medication from the vial into the syringe.

8. The automated system of claim 7, wherein the cannula is

fluidly connected to a main conduit that is selectively connected at its opposite end

to the diluent source and to a means for creating either negative pressure or positive

within the main conduit for aspirating fluid into the main conduit or discharging

fluid therefrom, respectively.

9. The automated system of claim 8, wherein the means

comprises:

a collection member for storing diluent received from either the

diluent source or diluent that is drawn into the collection member from a

downstream section of the main conduit; and

a control unit and a valve mechanism that are operatively connected

to the collection member to create negative pressure therein to drawn fluid therein

or to create positive pressure to force fluid to be discharged therefrom.

10. The automated system of claim 9, wherein the collection

member comprises: a first syringe having a barrel with an interior having a first volume; and

a second syringe having a barrel with an interior having a second volume;

wherein each of the first and second syringes having a slideable

plunger contained in the respective barrel and each syringe being in selective fluid communication with each of the diluent source and the main conduit that leads to the

cannula.

11. The automated system of claim 10, wherein the first volume is

at least 50% greater than the second volume.

12. The automated system of claim 10, wherein the control unit comprises:

a first syringe driver associated with the first syringe for selectively moving the plunger a prescribed distance;

a second syringe driver associated with the second syringe for

selectively moving the plunger a prescribed distance; and

the valve mechanism includes a first valve for providing selective

fluid communication between the control unit and the diluent source and a second

valve for providing selective fluid communication between the control unit and the

downstream section of the main conduit.

13. The automated system of claim 12, wherein the first and

second syringes are fluidly interconnected by a connector conduit that has a valve

associated therewith for permitting selective flow between the syringes.

14. The automated system of claim 12, wherein at least one of the

first and second syringes has an input port and an output port with the input port

being connected to a first conduit that connects at its opposite end to the diluent

source with a valve being associated with the first conduit to provide selective

communication between the diluent source and the input port, the output port being

connected to a second conduit that connects at its opposite end to the main conduit

with a valve being associated with the second conduit to provide selective

communication between the output port and the main conduit.

15. The automated system of claim 12, wherein each of the first

and second syringe drivers comprises a stepper motor that operates such that an

incremental distance of movement of the plunger is equated to a number of steps

through which the motor is driven, thereby permitting precise control over the exact

distance that the plunger is moved.

16. The automated system of claim 9, wherein the main conduit is

primed with diluent fluid such that the diluent fluid is present along at least a

substantial length of the main conduit and the control unit operates so that the

prescribed amount of medication is drawn into a distal end of the main conduit with

an air block being present between the medication drawn into the main conduit and the diluent that is also present in the main conduit, the control unit operating to discharge the medication by introducing a volume of diluent into the main conduit

that equals the volume of the medication that is discharged therefrom.

17. The automated system of claim 16, further including:

a mixing device for agitating the vial with the medication and injected

diluent so that the desired reconstituted medication is produced, the mixing device in

communication with the central processor unit which instructs the mixing device to

be actuated for the stored mixing time.

18. The automated system of claim 17, wherein the mixing device

is a vortex mixer.

19. The automated system of claim 17, wherein the mixing device

is an automated vibrating device having a platform that receives the vial and an

adjustable hold down bar that is manipulated so that it travels towards the vial and

engages the vial at an end opposite the platform such that once the vial is securely

captured between the platform and hold down bar, vibrating device is actuated

resulting in the vial being shaken to agitate the medication and ensure that all of the

medication properly goes into solution.

20. The automated system of claim 1, further including:

a multi-use medication station where drug vials that are identified as multi-use medication vials are stored after the medication is reconstituted therein

and the prescribed dosage amount is aspirated therefrom by the cannula unit.

21. The automated system of claim 20, further including:

an automated vial gripper device for retrieving and securely holding a

selected vial containing the medication from a first location and transferring it to a plurality of stations downstream of the first location, the automated vial gripper

device being capable of moving in the x, y, and z directions and inverting the held

vial, wherein the vial gripper device delivers vials that are identified as multi-use to

the multi-use station after the prescribed dosage amount is aspirated and when reconstituted medication remains in the vial.

22. The automated system of claim 7, wherein the cannula

comprises a vented cannula that is selectively vented to atmosphere.

23. The automated system of claim 7, wherein the cannula

comprises an automated cannula that includes a tip that is movable within a vial that

holds the medication to permit all of the medication to be drawn from the vial.

24. An automated medication preparation system including

automated syringe preparation including reconstitution of the medication and

delivery of the reconstituted medication to a syringe, the system comprising:

an automated device for delivering a prescribed dosage amount of

medication to the syringe by injecting the medication through an uncapped barrel in a just-in-time for use manner;

a controller in commumcation with the automated device and

including a database for storing reconstitution information that is used to control the

the resultant medication and a mixing time for agitating the medication; and

wherein the automated device for delivering a prescribed dosage

amount of medication to the syringe comprises an automated robotic device having a

cannula unit that is rotatably mounted to a vertical base which is itself rotatably

mounted to a lower ground base, wherein the cannula unit includes a cannula extending thereaway for performing at least one of the following operations: (1)

receiving and discharging diluent from a diluent supply in a prescribed amount to

reconstitute the medication in a vial; and (2) aspirating and later discharging

reconstituted medication from the vial into the syringe.

25. An automated medication preparation system including

automated syringe preparation including delivery of a prescribed amount of

medication to the syringe, the system comprising:

a source of medication;

a first conduit connected at one end to the source of medication and at

the other end to an input port of a pump that has an output port that is connected to

a second conduit that terminates at its other end in a connector;

an automated rotary device that is indexed to advance one syringe from one station

to another station, the rotary device having a feature formed as part thereof for releasably retaining the syringe;

an automated device for extending a plunger of a syringe barrel

positioned at a fluid transfer position of the rotary device, the automated device

being operatively connected to a control unit which instructs the automated device to

extend the plunger a predetermined distance based on the prescribed amount of medication; and

wherein the connector sealingly mates with an open end of the

syringe barrel so that extension of the plunger creates a negative pressure condition

within the barrel and results in the prescribed amount of medication being drawn

therein from the second conduit.

26. The automated system of claim 25, wherein the source of

medication comprises a bag filled with liquid medication.

27. The automated system of claim 25, wherein the pump is a

peristaltic pump that selectively pumps medication from the source into the second

conduit.

28. A method for automated preparation of a medication including

automated syringe preparation that includes reconstitution of the medication and

delivery of the reconstituted medication to a syringe, the method comprising the

steps of:

providing an automated device for delivering a prescribed dosage

amount of medication to the syringe by injecting the medication through an uncapped barrel in a just-in-time for use manner;

inputting medication identifying information for identifying the

medication that is to be prepared for use; accessing and retrieving stored reconstitution instructions from a database that is

associated with the inputted medication identifying information, the reconstitution

instructions being for controlling the automated device for reconstituting the

instructions include at least a concentration of the resultant medication and a mixing

time for agitating the medication; and reconstituting the medication, in accordance with the stored

reconstitution instructions, in vial with an automated robotic device having a

rotatable cannula unit by first discharging a prescribed amount of diluent through the cannula unit into the vial; then agitating the medication in the vial, then

aspirating and later discharging the prescribed dosage amount of medication from

the vial into the syringe in a just-in-time for use manner.

29. The method of claim 28, wherein the cannula unit is in

selective fluid communication with a fluid pump apparatus that is in selective fluid

communication with a diluent source, the fluid pump apparatus having a first controllable syringe that is in fluid communication with the diluent source and with

a second controllable syringe that is also in selective fluid communication with the

cannula unit through a primed main conduit, each of the syringes being operably connected to a drive that causes either a positive or negative pressure to exist in a

barrel thereof, and the step of reconstituting the medication includes the steps of: opening fluid communication between the diluent source and the first

syringe and preventing fluid commumcation between the second syringe and the

cannula unit;

operating a drive of one of the first and second syringes to create a negative

pressure therein resulting in a prescribed amount of diluent being drawn into the

barrel thereof;

preventing fluid communication between the diluent source and the

first syringe and allowing fluid communication between the second syringe and the cannula unit;

operating the drive so as to discharge the prescribed amount of

diluent from one of the first and second syringes into the primed main conduit resulting in the prescribed amount of diluent being discharged through the cannula and into the vial;

agitating contents of the vial;

operating a drive of one of the first and second syringes to create a

negative pressure therein resulting in the prescribed dosage amount of medication

being aspirated into the main conduit with an air block separating the aspirated

medication from the diluent in the main conduit due to a volume of diluent, which is

equal to the prescribed dosage amount, be drawn into the syringe barrel; positioning the cannula within the syringe; and

operating the drive of one of the first and second syringes to create a

positive pressure therein resulting in the prescribed dosage amount of medication

being discharged from the main conduit into the syringe as a result of the volume of

diluent being discharged from the syringe into the main conduit.

30. An automated medication preparation system including

automated syringe preparation comprising:

a first automated gripping means for removing a tip cap from a barrel of one syringe and placing the removed tip cap at a first location;

an automated device for delivering a prescribed dosage amount of

medication to the syringe by injecting the medication through the uncapped barrel in

a just-in-time for use manner;

a second automated gripping means for replacing the removed tip cap on the syringe barrel after the medication is injected therein; and

a coupling device for joining the tip cap to the syringe barrel in a local area to produce a tamper evident syringe, wherein the syringe is automatically

advanced from the second automated gripping means to the coupling device.

31. The automated system of claim 30, wherein each of the first

and second automated gripping means comprises a robotic device having first and

second gripping arms that are spaced apart from one another in a first position and

are moved toward one another to a second position so as to securely capture and hold the tip cap between the first and second gripping arms.

32. The automated system of claim 31, wherein the robotic device

is movable at least along an x axis and a y axis.

33. The automated system of claim 30, further including:

a post at the first location for receiving and holding the removed tip

cap.

34. The automated system of claim 30, further including: an automated device for extending a plunger of the syringe barrel.

35. The automated system of claim 34, wherein the automated

device is operatively connected to a control unit which instructs the automated

device to extend the plunger a predetermined distance based on the prescribed

amount of medication.

36. The automated system of claim 30, further including an

automated rotary device that is indexed to advance the syringe from one station to

another station, the rotary device having a first feature formed as part thereof for releasably retaining the syringe and a second feature for holding the removed tip cap

as the syringe is advanced from one station to the next.

37. The automated system of claim 30, wherein the automated

device for delivering a prescribed dosage amount of medication to the syringe

comprises a robotic device having a pivotable arm that includes a platform section

having a first face and an opposing second face, a cannula extending through the

platform away from the first face for receiving the medication from a supply, the cannula being operatively connected to an apparatus that draws the medication from the supply into the cannula when actuated.

38. The automated system of claim 37, wherein the apparatus

comprises an aspirating device that applies negative pressure to an interior of the

cannula to cause the medication to be drawn from the supply to the cannula.

39. The automated system of claim 30, wherein the coupling

device comprises a heat-staking device including a tool for transferring heat to the tip cap resulting in localized melting of the tip cap and bonding to an outer surface

of a syringe luer connector.

40. The automated system of claim 39, wherein the tool is

selected from the group consisting of a heated wire and a heated probe.

41. The automated system of claim 30, wherein the tip cap is

joined to a syringe luer connector at a plurality of locations circumferentially around

the tip cap.

42. The automated system of claim 30, wherein the coupling

device comprises a laser that emits a laser beam that causes the joining between the

tip cap and a syringe luer connector in the local area.

no

43. The automated system of claim 30, wherein the coupling device comprises an ultrasonic welder that joins the tip cap and the syringe barrel

through pressure and high frequency mechanical vibrations, creating localized

frictional heat that melts the tip cap and syringe luer connector together, both of

which are formed of a plastic material.

44. The automated system of claim 30, wherein the coupling device is in communication with a controller that controls a temperature of a direct

contact-heated tool and monitors and controls a time period that the tool is in contact

with the tip cap.

45. The automated system of claim 30, wherein the tip cap and a

syringe luer connector are joined at a spot weld that has a substantially circular shape.

46. The automated system of claim 30, wherein the coupling

device comprises a heat-stake device that includes a plurality of interchangeable

direct contact-heated tools.

47. The automated system of claim 30, further including:

an automated member for receiving and holding the syringe barrel

after it is has been filled so that the movement thereof is prevented when the

coupling device acts on the syringe to join the tip cap to the syringe barrel.

ill

48. The automated system of claim 30, wherein the coupling device is a tamper evident tape dispenser that disperses tape and presses the tape

into contact with one side of the syringe barrel and then directing the tape up the

syringe barrel to the tip cap where the tape is laid across a top of the tip cap and

then down an opposite side of the syringe barrel.

49. An automated medication preparation system including

automated syringe preparation comprising:

a first automated device for removing a tip cap from a barrel of one

syringe and placing the removed tip cap at a first location;

an automated transfer device for delivering a prescribed dosage

amount of medication to the syringe by injecting the medication through the

uncapped barrel in a just-in-time for use manner;

a second automated device for replacing the removed tip cap on the syringe barrel after the medication is injected therein; and

a station for making the syringe tamper evident, the station including

a device for joining the tip cap to the syringe barrel in a local area by heating and

reflowing a section of the tip cap into contact with the syringe barrel whereupon

cooling, a local weld is formed between the tip cap and the syringe barrel, wherein

the syringe is automatically advanced from the second automated device to the

station for making the syringe tamper evident.

50. An automated medication preparation system including

automated syringe preparation comprising: a first automated gripping means for removing a tip cap from a barrel

of one syringe and placing the removed tip cap at a first location; an automated device for delivering a prescribed dosage amount of

a just-in-time for use manner;

a second automated gripping means for replacing the removed tip cap

on the syringe barrel after the medication is injected therein; and

a mechamsm for capturing the syringe containing the prescribed

dosage amount between two sheets of plastic material and then evacuating air from between the sheets to form and capture the syringe in a shrink wrapped package which has a perforated seam formed therein to assist a user in opening of the

package.

51. An automated medication preparation system including automated syringe preparation comprising:

a plurality of stations for removing a tip cap from a barrel of one

syringe, delivering a prescribed dosage amount of medication to the syringe in a

just-in-time for use manner, and replacing the removed tip cap on the syringe luer

connector after the medication is delivered thereto; and

a station for making the syringe tamper evident, the station including

a device for joining the tip cap to a syringe luer connector in a local area by forming

a local weld between the tip cap and the syringe luer connector so as to restrict

twisting and removal of the tip cap, wherein the syringe is automatically advanced from the second automated device to the station for making the syringe tamper

evident.

52. A method for just-in-time removal of a tip cap from a syringe

barrel, filling the syringe with a prescribed dose of medication, replacing the tip cap

on the syringe barrel and making the syringe tamper evident, the method including

the steps of: removing the tip cap from the syringe luer connector to open the

syringe barrel and placing the removed tip cap at a first location;

delivering the prescribed dose to an interior of the syringe barrel;

gripping the removed tip cap at the first location and moving it to the syringe barrel containing the prescribed dose;

replacing the tip cap on a syringe luer connector; and

joining the tip cap to the syringe luer connector in a local area by heating and reflowing a section of the tip cap into contact with the syringe luer

connector whereupon cooling, a local weld is formed between the tip cap and the

syringe luer connector, wherein the syringe is automatically advanced from a station

where the tip cap is replaced to a station for making the syringe tamper evident

where the local weld is formed.

53. The method of claim 52, wherein the step of delivering the

prescribed dose comprises the steps of:

providing a robotic fluid transfer device having a cannula unit that is

positioned between first and second positions, wherein the cannula unit includes a cannula;

connecting the cannula to an apparatus that draws the prescribed dose from a medication supply to the cannula when the apparatus is actuated and the

cannula unit is in the first position;

moving the robotic fluid transfer device to the second position; and

delivering the prescribed dose into the syringe body through an

entrance port created when the tip cap is removed.

54. The method of claim 53, wherein the apparatus aspirates the prescribed dose from the medication supply.

55. The method of claim 53, further including the steps of:

providing an automated device for extending a plunger of the syringe;

and

extending the plunger a predetermined distance based upon a volume

of the prescribed dose.

56. The method of claim 52, wherein the step of joining the tip

cap to the syringe barrel comprises the steps of:

providing a heat-stake device that includes a direct contact-heated

tool; heating the tool to a predetermined temperature and placing the tool into contact with an outer surface of the tip cap;

directing the tool into the tip cap by applying a predetermined pressure thereto causing a local section of the tip cap to melt and reflow into contact

with an outer surface of the syringe luer connector; and

removing the tool such that the reflow cools and the local weld is

formed.

57. The method of claim 52, wherein the step of joining the tip

cap to the syringe luer connector comprises the steps of:

providing an ultrasonic welder that includes a probe;

activating the welder so as to create vibratory energy that is

transferred through the probe directly to the tip cap and the syringe luer connector,

while the probe simultaneously applies a welding pressure; and

transmitting the vibrations through the tip cap and syringe luer

connector to a joint area where the vibratory energy is converted to heat through

friction which causes the tip cap and the syringe luer connector to melt, whereby the tip cap is joined to the syringe barrel.

58. The method of claim 52, wherein the step of joining the tip

cap to the syringe barrel comprises the steps of:

providing a laser;

directing an emitted laser beam to an outer surface of the tip cap to

cause a local section of the tip cap to melt and reflow into contact with an outer surface of the syringe luer connector; and deactivating the laser such that the reflow cools and the local weld is

formed.

59. An automated means for storing, dispensing and orienting injectable drug vials for a robotic application comprising:

a robotic vial gripper device for holding and transferring one vial from one station to a next station of the robotic application; and

a detector that determines whether the vial is in a correct orientation throughout one

or more stations of the robotic application.

60. The automated means of claim 59, wherein the robotic

application comprises an automated medication preparation system including

automated syringe preparation including reconstitution of the medication and

delivery of the reconstituted medication to a syringe.

61. The automated means of claim 59, wherein the detector

determines whether the vial is an upright position or is in an opposite downright

position relative to ground.

62. The automated means of claim 59, wherein the vial includes a

magnetic chip attached thereto at one end and the detector comprises a detector that

is capable of detected a change in a surrounding magnetic field such that when the

vial is in a correct orientation, the magnetic chip of the vial influences the detector

and causes it to generate a control signal indicating that the vial is in the correct

orientation and can be advanced to a next station.

63. The automated means of claim 59, wherein the vial includes

an optical marker and the detector comprises an optical detector that is capable of detecting the optical marker such that when the vial is in a correct orientation, the

detector recognizes the optical marker of the vial and generates a control signal that

indicates that the vial is in the correct orientation and can be advanced to a next

station.

64. The automated means of claim 59, wherein the detector is

positioned at a location prior to a station where medication contained in the vial is

reconstituted using a cannula unit that includes a cannula extending therefrom that

pierces a septum of a decapped vial.

65. The automated means of claim 59, wherein if the vial is not in

a correct orientation, the detector sends a control signal that causes the vial to be

removed from the robotic application;

66. The automated means of claim 59, wherein the detector is

present at a station where the vial is placed on a rotatable pedestal and is positively

identified by scanning equipment, the detector serving to determine whether the vial

is placed upright on the pedestal prior to the vial gripper device engaging and

removing the vial therefrom for delivery to the next station.

67. The automated means of claim 59, wherein a cap end of the

vial includes a member attached thereto, the detector being configured and positioned so that when the vial is properly orientated, the member lies within a

scope of field of the detector and the detector detects the member and generates a

control signal indicating that the vial is properly orientated and should be advanced to a next station.

68. The automated means of claim 67, wherein the member

comprises an optical marker.

69. The automated means of claim 67, wherein the member

comprises a magnetic chip.

70. The automated means of claim 67, wherein the member is a

scannable tag attached to the vial and the detector is a reader such that if and when

the scannable tag passes through a beam of the detector, the detector reads the tag

and generates a control signal indicating that the vial is in the proper orientation and should be advanced to the next station.

71. An automated medication preparation system including

automated syringe preparation in which medication contained in an injectable drug

vial is delivered in a prescribed dosage amount to a syringe, the system comprising:

a robotic vial gripper device for capturing the injectable drug vial

from a drug storage area and delivering it to one or more vial processing stations;

an automated device associated with a fluid transfer station for

delivering a prescribed dosage amount of medication from the vial to the syringe through an uncapped barrel thereof in a just-in-time for use manner, the fluid

transfer station being located downstream of the vial processing stations; and

a detector for determining whether the vial is in a correct orientation

prior to the vial being delivered to the fluid transfer station by the robotic vial

gripper device.

72. An automated syringe preparation mechanism for an automated medication preparation system, the mechamsm comprising:

a first automated gripping device for removing a tip cap from a barrel

tip of one syringe and placing the removed tip cap at a first location; and

a second automated gripping device for replacing the removed tip cap

on the syringe barrel after medication has been injected therein, wherein each of the first and second automated gripping devices is in communication with a

programmable controller and each of the first and second gripping devices moves in

at least two directions.

73. The automated syringe preparation mechanism of claim 72,

wherein at least one of the first and second automated gripping devices has first and

second gripping arms that are spaced apart from one another in an open position and

are moved toward one another to a closed position so as to securely capture and

hold the tip cap between the first and second gripping arms.

74. The automated syringe preparation mechamsm of claim 73,

wherein each of the first and second gripping arms has a platform with a shaped cut out formed at one edge thereof and the two shaped cut outs are aligned with one

another so that when the gripping arms are in the closed position, the shaped cut

outs define an opening that is sized to receive and hold the tip cap.

75. The automated syringe preparation mechanism of claim 72,

wherein each of the first and second automated gripping devices is movable along an

x axis and a y axis.

76. The automated syringe preparation mechamsm of claim 72, wherein each of the first and second automated gripping devices has a first control

mechanism for controlling opening and closing of gripper arms that grasp and retain

the tip cap; a second control mechanism for controlling up and down movement of

the gripping device and a third control mechanism for controlling inward and

outward movement of the gripping device.

77. The automated syringe preparation mechanism of claim 76,

wherein each of the first, second and third control mechanisms is a pneumatic

device that upon actuation causes movement of the device in at least one direction.

78. The automated syringe preparation mechanism of claim 72,

further including:

a sensor device including at least one sensor that emits a light beam

and a reflector for reflecting the light beam, the sensor device being mounted

relative to gripper arms that grasp and retain the tip cap so that the light beam passes through a space between the gripper arms where the tip cap is received, the

sensor device in communication with the programmable controller so that a control

signal is delivered to the programmable controller when the tip cap is disposed

within the space, thereby impinging the light beam.

79. The automated syringe preparation mechamsm of claim 76,

wherein each of the first and second automated gripper devices includes a vertical

base with the gripper arms being disposed closer to an upper end of the vertical

base, the second control mechanism operatively connected to the vertical base to

cause controlled up and down movements thereof; the third control mechanism

operatively connected to the vertical base to cause controlled inward and outward

movements thereof.

80. The automated syringe preparation mechanism of claim 79,

wherein the second and third control mechanisms are one of pneumatic devices and

mechanical motorized devices that each moves the vertical base between two

positions.

81. The automated syringe preparation mechamsm of claim 72,

wherein the first and second automated gripping devices are the same.

82. The automated syringe preparation mechamsm of claim 76,

wherein the first automated gripping device is positionable between a starting position, a second position where the tip cap is grasped by the gripper arms for removal from the syringe and a third position where the tip cap is disposed over a

feature for retainingly parking the tip cap.

83. The automated syringe preparation mechanism of claim 82,

wherein the feature comprises a post that is formed as part of the support for

receiving and holding the removed tip cap.

84. The automated syringe preparation mechanism of claim 72,

wherein the automated medication preparation system includes an automated rotary

device that is indexed to advance the syringe from one station to another station, the

rotary device having a feature for holding the removed tip cap as the syringe is

advanced from one station to the next.

85. A method of removing, parking and replacing a tip cap from a

syringe, the method comprising the steps of:

providing an automated device for removing the tip cap from an

empty syringe, placing the tip cap at a remote location, and replacing the tip cap on

a filled syringe, the device comprising a support frame that is movable along at least

an x axis and a y axis; a gripper mechanism including a pair of gripper arms that are

positionable between an open position and a closed position in which the tip cap is

securely held therebetween; and a programmable controller in commumcation with a

plurality of drive actuators that controUably drive the gripper arms and the support frame to desired positions; moving the vertical base to a first position where the open gripper

arms are disposed about the tip cap of the syringe;

closing the gripper arms to securely capture and retain the tip cap and

moving the vertical base to a raised position to cause the removal of the tip cap as it

is securely held between the gripper arms;

moving the vertical base so that the held tip cap is disposed above a

remote feature for holding the removed tip cap and opening the gripper arms so that the tip cap falls onto the feature;

moving the vertical base and closing the gripper arms to as to securely retain the tip cap and lift it from the feature after the syringe has been

filled; and

moving the vertical base to a position above the filled syringe and

then lowering the held tip cap until the tip cap engages and is securely replaced on the processed syringe.

86. A method for just-in-time removal of a tip cap from a syringe barrel, filling the syringe with a prescribed dose of medication and replacing the tip cap on the syringe barrel, the method including the steps of:

securing the syringe barrel to a device of an automated preparation system;

gripping and removing the tip cap from the syringe barrel to open up

an interior of the syringe barrel and placing the removed tip cap at a first location; delivering the prescribed dose to the interior of the syringe barrel

through the open syringe barrel; gripping the removed tip cap at the first location and moving it to the syringe barrel containing the prescribed dose; and

replacing the tip cap on the syringe barrel.

87. An automated device for extending a plunger of a syringe a defined distance within a syringe barrel based upon inputted syringe information,

the device comprising:

a housing;

an adjustable plunger extension mechanism that includes a movable

component that intimately engages the plunger so that movement of the component

is translated into extension of the plunger, the component including a controllable

drive that moves the component the defined distance; and a controller that receives the inputted syringe information and

calculates the defined distance that the plunger is moved based on the inputted syringe information and instructs the controllable drive to move the plunger the

defined distance.

88. The automated device of claim 87, further including:

a sensor device that signals a controller when the component reaches

one end of its permitted path of travel, the controller in communication with the

controllable drive to instruct the drive to cease moving the component in a specific

direction when the component reaches one end of its permitted path of travel.

89. The automated device of claim 87, wherein the adjustable plunger extension mechanism includes a support frame, a carrier that moves linearly

therealong and includes a pair of arms that engage the plunger.

90. The automated device of claim 87, wherein the controllable

drive comprises a servo motor and a screw drive mechanism that is operatively

-coupled to the carrier so that actuation of the servo motor is translated into

movement of a drive spindle of the screw drive mechanism which in turn causes

movement of the component.

91. The automated device of claim 90, wherein the servo motor

rotates in a first direction and in a second opposite direction such that rotation in the

first direction causes the component to move linearly in a first direction and rotation

in the second direction causes the component to move linearly in a second direction.

92. The automated device of claim 87, wherein the controllable

drive comprises a servo motor whose actuation causes the servo motor to go through

a predetermined number of steps.

93. The automated device of claim 92, wherein the controller is

operatively connected to the servo motor and sends a control signal to the servo

motor to instruct the servo motor to go through a predetermined number of steps,

wherein there is a correlation between the number of steps and the defined distance

that the component is driven which in turn represents the defined distance that the plunger is extended creating a volume within the syringe to accept a prescribed volume of medication.

94. The automated device of claim 93, wherein the inputted

syringe information includes a syringe type, a barrel diameter, and a desired dose

volume of medication to be filled into the syringe, wherein the controller calculates

the defined distance that the plunger needs to be extended based upon the inputted

syringe information and then calculates the number of steps that the servo motor is

driven through in order to extend the plunger the defined distance.

95. The automated device of claim 87, wherein the component includes first and second verticals walls that one connected at end thereof, the

vertical walls being parallel to one another and spaced apart from one another,

wherein other ends of the vertical walls include features for intimately engaging the

plunger to cause the extension thereof when the component is moved linearly.

96. The automated device of claim 95, wherein the features

comprise a pair of flange members disposed at the other ends of the vertical walls,

each flange member extending beyond the vertical wall and into, a space between the two parallel vertical walls so as to overhang the vertical wall, wherein a diameter of

the plunger is less than a distance between the two spaced vertical walls but greater

than a distance between the flange members so that the flange members grip and engage a lip of the plunger and cause the extension of the plunger.

97. The automated device of claim 96, wherein the component

travels from a starting position in which the component is in a raised position and a

lowered position where the component has traveled away from the raised position,

the plunger being received within the space between the vertical walls in the starting

position with the lip of the plunger being proximate to or seated against the flange

members and wherein movement of the component from the starting position to the

lowered position extends the plunger the desired defined distance prior to the

syringe being removed from the automated device.

98. The automated device of claim 88, wherein the sensor device

includes a first sensor fixed at a first location at one end of the permitted length of travel for the component and a second sensor fixed to a second location at the other

end of the permitted length of travel, the sensors being constructed so that they

detect the presence of the movable component.

99. An automated syringe preparation mechanism for an

automated medication preparation system, the mechanism comprising:

a first automated gripping means for removing a tip cap from a barrel

of one syringe and placing the removed tip cap at a first location;

an automated device for delivering a prescribed dosage amount of

medication to the syringe by injecting the medication through the uncapped barrel in a just-in-time for use manner; and

a second automated gripping means for replacing the removed tip cap

on the syringe barrel after the medication is injected therein.

100. A method for just-in-time removal of a tip cap from a syringe barrel, filling the syringe with a prescribed dose of medication and replacing the tip

cap on the syringe barrel, the method including the steps of:

securing the syringe barrel to a device of an automated preparation system;

gripping and removing the tip cap from the syringe barrel to open up

an interior of the syringe barrel and placing the removed tip cap at a first location; extending a plunger a defined distance within the syringe barrel based

in part upon a volume of the prescribed dose;

delivering the prescribed dose to the interior of the syringe barrel through the open syringe barrel;

gripping the removed tip cap at the first location and moving it to the

syringe barrel containing the prescribed dose; and

replacing the tip cap on the syringe barrel.