Patent ID: 12201586

DETAILED DESCRIPTION

The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions may be provided in regard to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology.

It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

The present system comprises multiple features and technologies that in conjunction form a compounding system that can efficiently reconstitute pharmaceuticals in a sterile environment and deliver the compounded pharmaceutical to a delivery bag for use on a patient.

FIG.1illustrates a compounder system10according to an embodiment.FIG.2illustrates the system10with a transparent outer housing12andFIG.3illustrates the system with the housing removed. The system comprises a carousel assembly14that contains up to 10 individual cartridges16. The carousel14can hold more or less cartridges16if desired. The cartridges16are disposable and provide unique fluid paths between a vial18containing a powdered drug (or concentrated liquid drug), multiple diluents, and a receiving container. The cartridges16may, if desired, also provide a fluid path to a vapor waste container. However, in other embodiments, filtered or unfiltered non-toxic waste may be vented from the compounder to the environment reducing or eliminating the need for a waste port. Each cartridge contains a piston pump and valves that control the fluid intake, outtake, and fluid path selection during the steps of the compounding process as the fluid moves through the cartridge and into a receiving container.

The carousel assembly14is mounted on the apparatus such that it can rotate to bring different cartridges16into alignment with the pump drive mechanism20. The carousel14is typically enclosed within a housing12that can be opened in order to replace the carousel14with a new carousel14after removing a used one. As illustrated, the carousel14can contain up to 10 cartridges16, allowing a particular carousel to be used up to 10 times. In this configuration, each carousel assembly can support, for example, 10 to 100 receiving containers, depending on the type of compounding to be performed. For example, for hazardous drug compounding, a carousel assembly can support compounding to ten receiving containers. In another example, for non-hazardous drug compounding such as antibiotic or pain medication compounding, a carousel assembly can support compounding to 100 receiving containers. The housing12also includes a star wheel22positioned underneath the carousel14. The star wheel22rotates vials18of pharmaceuticals into position either in concert with, or separate from, the specific cartridges16on the carousel14. The housing12may also include an opening24for loading the vials18into position on the star wheel22.

Each one of the cartridges16in the carousel14is a disposable unit that includes multiple pathways for the diluent and vapor waste. Each cartridge16is a small, single disposable unit that may also include a “backpack” in which a tube for connection to the receiving container (e.g., an IV bag, a syringe, or an elastomeric bag) may be maintained. Each cartridge16also may include a pumping mechanism such as a piston pump for moving fluid and vapor through the cartridge16as well as a duel lumen needle in a housing that can pierce a vial puck26on top of a vial18once the vial18has been moved into position by the pump drive mechanism20. For example, the needle may pierce the vial puck26via the compressive action of the vial puck26, which is moved towards the needle. Each cartridge16also includes a plurality of ports designed to match up with the needles of a plurality of diluent manifolds. Each cartridge16also includes openings to receive mounting posts and a locking bayonet from the pump head assembly28. Although a locking bayonet is described herein as an example, other locking mechanisms may be used to retrieve and lock a cartridge to the pump head (e.g., grippers, clamps, or the like may extend from the pump head). Each cartridge16also includes openings allowing valve actuators from the pump motor mechanism to interact with the valves on each cartridge16.

Adjacent the housing12that holds the vials18and the carousel14is an apparatus30for holding at least one container32, such as an IV bag32as shown in the figures. The IV bag32typically has two ports such as ports34and36. For example, in one implementation, port34is an intake port34and port36is an outlet port36. Although this implementation is sometimes discussed herein as an example, either of ports34and36may be implemented as an input and/or outlet port for container32. For example, in another implementation, an inlet34for receiving a connector at the end of tubing38may be provided on the outlet port36. In the embodiment shown, the IV bag32hangs from the holding apparatus30, which, in one embodiment is a post with a hook as illustrated inFIGS.1-3. One or more of the hooks for hanging containers such as diluent containers, receiving containers, or waste containers may be provided with a weight sensor such as a load cell that detects and monitors the weight of a hung container. The holding apparatus30can take any other form necessary to position the IV bag32or other pharmaceutical container. Once the IV bag32is positioned on the holding apparatus30, a first tube38(a portion of which is shown inFIG.1) is connected from a cartridge16on the carousel14to the inlet34of the IV bag32. For example, the first tube may be housed in a backpack attached to the cartridge and extended from within the backpack (e.g., by an operator or automatically) to reach the IV bag32. A connector37such as a Texium® connector may be provided on the end of tube38for connecting to inlet34of receiving container32.

On the opposite side of the compounder10is an array of holding apparatuses40for holding multiple IV bags32or other containers. In the illustrated version of the compounder10, five IV bags42,44are pictured. Three of these bags42may contain diluents, such as saline, D5 W or sterile water, although any diluent known in the art may be utilized. An additional bag in the array may be an empty vapor waste bag44for collecting waste such as potentially hazardous or toxic vapor waste from the mixing process. An additional bag44may be a liquid waste bag. The liquid waste bag may be configured to receive non-toxic liquid waste such as saline from a receiving container. Liquid waste may be pumped to the waste bag via dedicated tubing using a mechanical pump. In operation, diluent lines and a vapor waste line from the corresponding containers42and44may each be connected to a cartridge16through a disposable manifold.

The compounding system10also includes a specialized vial puck26designed to attach to multiple types of vials18. In operation, the vial puck26is placed on top of the vial18containing the drug in need of reconstitution. Once the vial puck26is in place, the vial18is loaded into the star wheel22of the compounder10. Mating features on the vial puck26provide proper alignment both while the vial puck26is in the star wheel22and when the vial puck26is later rotated into position so that the compounder10can remove it from the star wheel22for further processing.

The pump drive mechanism20is illustrated inFIG.4, and in an exploded view inFIG.5, according to an embodiment. In the embodiment shown inFIGS.4and5, the pump drive mechanism20comprises a multitude of sections. At one end of the pump drive mechanism20is the rotation housing46, which holds the drive electronics and includes locking flanges94on its housing96for flexible tubing50which may run from one or more diluent containers and/or waste containers to one or more corresponding manifolds. The rotation housing46is capable of rotating around its axis to rotate the rest of the pump drive mechanism20. The rotation housing46includes bearing ribs52on its ends which allow it to rotate. For example, the pump drive mechanism may be configured to rotate through any suitable angle such as up to and including 180°, or more than 180°.

Next to the rotation housing46is the motor mount54, which is shown alone from various angles inFIGS.6-8, according to an embodiment. In the embodiment shown inFIGS.4-8, the cam housing56, shown in further details from various anglesFIGS.9-11, is connected to the motor mount54, which includes cams and gears that control the rotary motion of the motors and the axial motion of the pump drive mechanism20as it moves into position to pick up a cartridge16and a vial18.

The compounder system also includes a diluent magazine (not shown) that mounts in a slot60located on the side of the pump drive mechanism. The diluent magazine may be a disposable piece configured to receive any number of individual diluent manifolds operable as diluent ports. The diluent manifolds (not shown) may be modular so they can easily and removably connect to each other, the magazine, and/or connect to the pump drive mechanism20.

The final portion of the pump drive mechanism20is the pump head assembly28. The pump head assembly28includes the vial grasping arms76, the vial lift78, the pump cartridge grasp80, the pump piston eccentric drive shaft82with arm222, the valve actuation mechanisms84, as well as the motors that allow the pump drive mechanism20to move forward and back and to rotate in order to mix the pharmaceutical in the vial18once the diluent has been added to it. The compounder10may also include an input screen86such as a touch screen86as shown in the figures to provide data entry by the user and notifications, instructions, and feedback to the user.

The operation of the compounder system10will now be generally described in the flowchart illustrated atFIG.21, according to an embodiment. In the first step88, a user inserts a new diluent manifold magazine having a plurality of manifolds (e.g., diluent manifolds and waste manifolds) into the slot60on the side of the pump head assembly28. Manifolds may be loaded into the magazine before or after installing the magazine in the slot60. The manifolds maintain needles inside the housing of the manifold until the cartridge16is later locked in place. The magazine may contain any number of diluent manifolds and vapor waste manifolds. In one illustrative system, there may be three diluent manifolds and one vapor waste manifold. In the next step92, diluent tubing is connected to corresponding diluent bags. The tubes may be routed through locking flanges on a surface (e.g., the front surface) of the compounder frame to hold them in place. For example, in the illustrated embodiment ofFIG.24, the tubes are held in place with locking flanges2402on the frame of the compounder. Alternatively, other types of clips or locking mechanisms known in the art may be used to hold the tubes securely in place. In the illustrated embodiment ofFIG.4, the additional flanges94positioned on the outside housing96of the pump drive mechanism20are provided for securing internal wiring of the compounder. In the next step98, waste tubing may be connected to the vapor waste bag44. In other embodiments, tubing may be pre-coupled between the manifolds and associated containers such as diluent containers and/or waste containers and the operations of steps92and98may be omitted.

If desired, in the next step100, a new carousel14may be loaded into a carousel mounting station such as a carousel hub of the compounder system. The carousel14may contain any number of disposable cartridges16arranged in a generally circular array. In the next step110, a vial puck26is attached to the top of a vial18of a powdered or liquid pharmaceutical for reconstitution and the vial18is loaded into the star wheel22under the carousel14in the next step112. Step110may include loading multiple vials18into multiple vial puck recesses in star wheel22. After one or more vials are loaded into the star wheel, the vials are rotated into position to enable and initiate scanning of the vial label of each vial. In one embodiment, the user will be allowed to load vials into the star wheel until all vial slots are occupied with vials before the scanning is initiated. A sensor may be provided that detects the loading of each vial after which a next vial puck recess is rotated into the loading position for the user. Allowing the user to load all vials into the star wheel prior to scanning of the vial labels helps increase the efficiency of compounding. However, in other implementations, scanning of vial labels may be performed after each vial is loaded or after a subset of vials is loaded. Following these setup steps, the next step114is for a user to select the appropriate dosage on the input screen.

After the selection on the input screen86, the compounder10begins operation116. The star wheel22rotates the vial into alignment118with the vial grasping calipers76of the pump head assembly28. The vial puck26includes, for example, gears that interface with gears coupled to a rotational motor that allow the vial18to rotate120so that a scanner (e.g., a bar code scanner or one or more cameras) can scan122a label on the vial18. The scanner or camera (and associated processing circuitry) may determine a lot number and an expiration date for the vial. The lot number and expiration date may be compared with other information such as the current date, recall or other instructions associated with the lot number, compounder operators such as pharmacy technicians (techs), inventory levels for that lot number, etc. In this way, the lot number and/or expiration date from an imaged label can be used to support activities, such as productivity reporting. For example, the pharmacist can keyword search a particular lot number and see which pharmacy techs have the most experience handling this particular type of drug. As another example, a pharmacist can search the hospital/pharmacy inventory database and determine an inventory level of drugs associated with this lot number and expiration date.

Once the vial18is scanned and aligned, in the next step124the pump drive mechanism20moves forward into position to grip the vial18with the calipers76. The forward movement also brings the mounting posts130and locking bayonet128on the front of the pump head assembly28into matching alignment with corresponding openings on a cartridge16. In the next step126the cartridge16is locked in place on the pump head assembly28with the locking bayonet128and the calipers76grip132the vial puck26on the top of the vial18. The calipers76then remove132the vial18from the star wheel22by moving backward, while at the same time pulling134the cartridge16off of the carousel14.

In some embodiments, the cartridge16includes a backpack that includes a coiled tube. In this embodiment, in step136the pump drive mechanism20tilts the cartridge16toward the user to expose the end of the tube and prompts138the user to pull the tube out of the backpack and connect it to the receiving bag32. In an alternative embodiment, the tube38is exposed on the side of the carousel14once the cartridge16is pulled away from the carousel14. In another alternative embodiment, the tube38is automatically pushed out (e.g., out of the backpack) thus allowing the user to grab onto the connector located at the end of the tube and connect to the receiving container. The system prompts138the user to pull the tube out from the carousel14and connect it to the input34of the IV bag32. Once the tube38is connected, in step140the user may notify the compounder10to continue the compounding process by interacting with the input screen86.

At step142, the vial18is pulled up towards the cartridge16so that one or more needles such as a coaxial dual lumen needle of the cartridge16pierce the top of the vial puck26and enter the interior of the vial18. Although the example ofFIG.21shows engagement of the needle with the vial puck after the user attaches the tube from the cartridge to the receiving container, this is merely illustrative. In another embodiment, steps138and140may be performed after step142such that engagement of the needle with the vial puck occurs before the user attaches the tube from the cartridge to the receiving container.

Diluent is pumped144into the vial18through the cartridge16and a first needle in the proper dosage. If necessary, a second or third diluent may be added to the vial18via a second or third diluent manifold attached to the cartridge16. Simultaneously, vapor waste is pumped144out of the vial18, through a second needle, through the cartridge16and the vapor waste manifold, and into the vapor waste bag44. The valve actuators84on the pump head assembly28open and close the valves of the cartridge16in order to change the fluid flow paths as necessary during the process. Once the diluent is pumped into the vial18, the pump drive mechanism20agitates the vial18in the next step146by rotating the vial lift78up to, for example 180 degrees such that the vial18is rotated between right-side-up and upside-down positions. The agitation process may be repeated for as long as necessary, depending on the type of pharmaceutical that is being reconstituted. Moreover, different agitation patterns may be used depending on the type of drugs being reconstituted. For example, for some drugs, rather than rotating by 180 degrees, a combination of forward-backward, and left-right motion of the pump head may be performed to generate a swirling agitation of the vial. A plurality of default agitation patterns for specific drugs or other medical fluids may be included in the drug library stored in (and/or accessible by) the compounder control circuitry. Once the agitation step is complete, the pump drive mechanism rotates the vial to an upside down position or other suitable position and holds it in place. In some embodiments, a fluid such as a diluent already in the receiving container32may be pumped (e.g., through the cartridge or via a separate path) into a liquid waste container to allow room in the receiving container for receiving the reconstituted medicine.

In the next step148, the valve actuators84reorient the valves of the cartridge and the pumping mechanism of the cartridge16is activated to pump150the reconstituted drug into the receiving bag32through the attached tube. Once the drug is pumped into the receiving bag32, in the next step152the pump drive mechanism20clears the tube38by either pumping filtered air or more diluent through the tube38into the receiving bag32after another valve adjustment to ensure that all of the reconstituted drug is provided to the receiving bag32. In some scenarios, a syringe may be used as a receiving container32. In scenarios in which a syringe is used as the receiving container32, following delivery of the reconstituted drug to the syringe, a vacuum may be generated in tube38by pump drive mechanism20to remove any air or other vapors that may have been pushed into the syringe so that, when the syringe is removed from tube38, the reconstituted drug is read for delivery to a patient and no air or other unwanted gasses are present in the syringe.

The system then prompts154the user to remove the tube38from the receiving container32. The user may then insert the connector (e.g., a Texium® or SmartSite® connector) into its slot in the backpack or carousel and an optical sensor in the pump head may sense the presence of the connector and automatically retract the tube into either the carousel or the backpack. The tube is pulled back into either the carousel14or the backpack, depending on which type of system is in use. In the next step156, the compounder10rotates the vial18back into alignment with the star wheel22and releases it. The used cartridge16may also be replaced on the carousel14. The used cartridge may be released when a sensor in the pump drive determines that the tube has been replaced in the cartridge (e.g., by sensing the presence of a connector such as a Texium® connector at the end of the tube in the backpack of the cartridge through a window of the cartridge). The carousel14and/or star wheel22then may rotate158to a new unused cartridge16and/or a new unused vial18and the process may be replicated for a new drug. In some circumstances (e.g., multiple reconstitutions of the same drug), a single cartridge may be used more than once with more than one vial.

The cartridges16are designed to be disposable, allowing a user to utilize all the cartridges16in a given carousel14before replacing the carousel14. After a cartridge16is used, the carousel14rotates to the next cartridge16, and the system software updates to note that the cartridge16has been used, thus preventing cross-contamination from other reconstituted drugs. Each cartridge16is designed to contain all the necessary flow paths, valves, filters and pumps to reconstitute a drug with multiple diluents if necessary, pump the reconstituted drug into the receiving container, pump vapor waste out of the system into a waste container, and perform a final QS step in order to make sure that the proper amount of drug and diluent is present in the receiving container. This complete package is made possible by the specific and unique construction of the cartridge16, its flow paths, and its valve construction.

An embodiment of a cartridge16is illustrated inFIG.22. As shown inFIG.22, cartridge16may include a cartridge frame160, a cartridge bezel164, as well as a piston pump166, a needle housing168and a needle assembly170. The cartridge frame160provides the main support for each cartridge16and includes diluent chambers, a vapor waste chamber, a pumping chamber, a hydrophobic vent, an exit port, and/or other features as described hereinafter that can be connected to a tube that connects to the receiving container32.

The frame160of the cartridge16also includes locating features that allow each cartridge16to be removably mounted to the pump head assembly28. These features include, for example, three openings198to receive mounting posts130from the pump head assembly28, and a keyhole210that allows a locking bayonet128to be inserted therein and turned to lock the cartridge16to the pump head assembly28for removal from the carousel14. An outlet port extension220may be present in some embodiments. The piston pump166is mounted within a chamber with a rod194positioned within a silicone piston boot. Furthermore, the bezel164includes openings228in which the valves190of the sealing membrane are located and be accessed by the valve actuators84. Moreover, the bezel164includes openings230that allow a fluid manifold to be connected to the diluent and vapor waste chambers in the cartridge16. Bezel164may also include an opening that facilitates the detection of a connector (e.g., a Texium® or SmartSite® connector) when the user inserts the connector into the provided slot when compounding is complete. In operation, the needles of the fluid manifold enter through the openings230in the bezel164and pierce the sealing membrane to gain fluidic access to the diluent and vapor waste chambers defined in the cartridge16between the sealing membrane and the cartridge frame160. Further details of various embodiments of the cartridge16will be discussed hereinafter.

Referring toFIG.23, an exemplary embodiment of a carousel14removed from the compounder10is illustrated, according to an embodiment. The carousel14ofFIG.23includes an array of ten cartridges16in this embodiment, but it should be understood that more or fewer cartridges16can be present on the carousel14, leaving some of the carousel14pockets500empty, or the frame510of the carousel can be designed to have more or fewer cartridge pockets500. The carousel14also includes a cover511that prevents a user from accessing the tubes coupled to each of the cartridges16directly. The cover511may be removed if necessary to access the backs of the cartridges16. In the example implementation ofFIG.23, a connector such as a Texium® attachment548is disposed adjacent each cartridge16, the attachment548being attached to the tube38that runs from the extension220on each cartridge16.

FIGS.24-29show the compounder10according to another embodiment. As shown inFIG.24, holding apparatus40may be implemented as an extended arm providing support for mounting devices for each of containers42and44. Holding apparatus40and holding apparatus30may each include one or more sensors such as weight sensors configured to provide weight measurements for determining whether an appropriate amount of fluid has been added to or removed from a container or to confirm that fluid is being transferred to and/or from the appropriate container (e.g., that the appropriate diluent is being dispensed). A scanner2404may be provided with which each diluent container and/or the receiving container can be scanned before and/or after attachment to compounder10. As shown inFIG.24, a carousel cover2400and tube management structures2402may also be provided on compounder10in various embodiments. For example, tubes connected between containers42and/or44and corresponding manifolds can each be mounted in a groove of tube management structure2402to prevent tangling or catching of the tubes during operation of compounder10.

As shown inFIG.25, an opening2502may be provided by which vials18can be installed in the star wheel. Additionally, an exterior pump2500may be provided for pumping non-toxic liquid waste from, for example, receiving container32to a waste container44(e.g., for pumping a desired amount of saline out of receiving container32quickly and without passing the liquid waste through a cartridge and/or other portions of the compounder).

A fluidics module2504may be provided that includes several container mounts2506. Container mounts2506may be used for hanging diluent and waste containers and may include sensor circuitry for sensing when a container has been hung and/or sensing the weight of the container. In this way, the operation of compounder10can be monitored to ensure that the correct diluent contain has been scanned and hung in the correct location and that the waste is being provided in an expected amount to the appropriate waste container.

As shown inFIG.26, pump2500and display86may be mounted to a chassis2600. Pump drive20may be mounted partially within the chassis2600with pump head assembly28extending from the chassis to a position which allows the pump head assembly to rotate (e.g., to turn over or agitate a vial). Carousel14is also shown inFIG.26without any cartridges mounted therein so that cartridge mounting recesses500can be seen.

Star wheel22(sometimes referred to herein as a vial tray) is shown inFIG.26with several empty vial puck recesses2604. Vial tray22may be rotated and an actuating door2608may be opened to facilitate loading of vials18into the vial puck recesses2604in vial tray22. In some embodiments, door2608may be closed before rotation of vial tray22to ensure that the operator's fingers are not in danger of injury from the rotating tray. However, this is merely illustrative. In other embodiments a sensor such as sensor2650(e.g., a light curtain) may be provided instead of (or in addition to) door2608to sense the presence of an operator in the vicinity of tray22and prevent rotation of the tray if the operator or any other obstruction is detected.

Similarly, a lid may be provided for carousel14to prevent contamination of cartridges16loaded therein, and to prevent injury to an operator due to rotation of the carousel. A lid sensor (not shown) may also be provided to detect the position (e.g., an open position or a closed position) of the lid. Rotation of carousel14may be prevented if the lid is not detected in a closed position by the lid sensor.

Each vial18that is inserted may be detected using a sensor such as sensor2652(e.g., a load sensor or an optical sensor) when placed in a vial puck recess2604. When detected, the inserted vial may be moved to a scanning position by rotating vial tray22and then the inserted vial18may be rotated within its position in vial tray22using a vial rotation motor2602to allow the vial label to be scanned.

A reverse perspective view of compounder10is shown inFIG.27in which scanning components can be seen. In particular, a camera2700is mounted in an opening in chassis2600and configured to view a vial18in a scanning position. Motor2602may rotate vial18through one or more full rotations so that camera2700can capture images of the vial label. In some embodiments, an illumination device2702(e.g., a light-emitting diode or other light source) may be provided that illuminates vial18for imaging with camera2700.

As shown inFIG.27one or more gears2704coupled to motor2602may be provided that engage corresponding gears on a vial puck26to which a vial18is attached at the scanning position. The vial tray22may be rotated so that the vial puck gears engage the rotation motor gears so that when the motor2602is operated the vial18is rotated.

FIG.27also shows how a magazine2706containing one or more manifolds may be mounted in a recess in pump head assembly28. A magazine slot in magazine2706for the vapor waste manifold may be keyed to prevent accidental connection of a diluent manifold in that slot (or a waste manifold in a diluent slot in the magazine). Other diluent slots in magazine2706may have a common geometry and thus any diluent manifold can fit in the magazine diluent slots. One or more manifold sensors such as manifold sensor2750(e.g., an optical sensor) may be provided in the manifold recess in pump head assembly28. Manifold sensor2750may be configured to detect the presence (or absence) of a manifold in a manifold recess (slot) in magazine2706to ensure that an appropriate manifold (e.g., a diluent manifold or waste manifold) is loaded at the expected position for compounding operations. In this way, the pump head may detect a manifold presence. The pump head and/or manifold sensors may communicate with the diluent load sensors to ensure proper positioning of the diluent manifolds. Various operational components2708such as valve actuators, needle actuators, mounting posts, a locking bayonet, and a drive pin can also be seen extended from pump head assembly28which are configured to secure and operate a pump cartridge16.

An exploded view of various components of compounder10is shown inFIG.28. Components discussed above such as display86, pump2500, dose hanger30, fluidics module2504, pump drive20with pump head assembly28, camera2700, and lighting device2702are shown. Additional components such as a chassis base2810and chassis housing2812of chassis2600are also shown inFIG.28. A rear panel2802having an electronics assembly2803can be mounted to chassis housing12and pump drive20may be seated in an opening2808in chassis housing2812that allows pump head assembly28to protrude from chassis housing2812. Processing circuitry for managing operations of compounder system10may be included in electronics assembly2803.

A vial tray and carousel drive assembly2800is also shown in which actuating door2608and a carousel hub2814can be seen. Carousel14may be placed onto carousel hub and rotated by vial tray and carousel drive assembly2800operating to rotate hub2814to move a selected cartridge in the carousel into position to be retrieved and operated by pump drive20. Vial tray and carousel drive assembly2800may include separate drive assemblies for the vial tray and for the carousel such that vial tray22and carousel14may be rotated independently.

FIG.29shows another perspective view of compounder10highlighting the locations of various particular components such as the carousel14with cartridges16mounted therein, a cartridge16having a backpack2900, a vial puck26for mounting vials18, and pump head assembly28with a diluent magazine2706containing a plurality of manifolds2906in accordance with an embodiment. Further features of the systems and methods for reading labels of vials18placed in the vial tray22(e.g., for determining the lot number and expiration dates of medicines) will be described hereinafter in connection withFIGS.30-34.

Turning now toFIG.30, a perspective view of a vial and carousel drive assembly3000is shown, according to an embodiment. In the example, ofFIG.30, vial tray22has been rotated so that a vial18is in an imaging position3001at which the label on the vial may be imaged. In the imaging position3001, gears3002of the vial puck that is attached to the vial18are engaged with gears2704of motor2602. In this way, motor2602can be operated to rotate vial18while vial18is in the vial puck recess of vial tray22at the imaging position. While motor2602rotates vial18, a camera such as2700(see, e.g.,FIGS.27and28) may capture images of the label on vial18. A light source such as light source2702may be operated to illuminate at least a portion of the label while the images are captured. Light source2702may be a line-wise light source configured to illuminate a vertical line on the vial while the vial is rotated so that each captured image includes an image of a vertical line on the vial. The vertical line images may be combined using processing circuitry associated with the camera and/or processing circuitry such as one or more processors for the compounder system to form a rectilinear image of the entire vial label. For example, the processing circuitry for processing and extracting information from images may be formed as hardware or software as part of electronics assembly2803ofFIG.28.

FIG.31shows an exploded perspective view of the vial and carousel drive assembly3000. As shown inFIG.31, assembly3000may include a carousel support frame3106on which the carousel hub3814and vial spin drive2602are mounted and that includes legs3106. Assembly3000may also include a drive mechanism3104having one or more additional motors such as motor3108configured via a plurality of gears and/or belts to actuate door2608, rotate vial tray22, and/or rotate carousel hub2814to rotate a carousel of cartridges mounted thereon. As shown, vial tray22may be disposed at least partially between carousel support frame3100and drive mechanism3104.

As shown inFIGS.30and31, carousel hub2814may have a polygonal shape. Carousel14may be provided with a central opening having a corresponding polygonal shape so that, when carousel14is placed onto carousel hub2814and carousel hub2814is rotated, the carousel is correspondingly rotated. However, this is merely illustrative. Carousel hub2814may be provided with other shapes such as a “D” shape or any other suitable shape that corresponds to the shape of the central opening in carousel14such that, when carousel14is placed onto carousel hub2814and carousel hub2814is rotated, the carousel is correspondingly rotated. As shown inFIG.31, drive mechanism3104may have an extension3114that extends into carousel hub2814to rotate hub2814responsive to operation of a motor of drive mechanism3104.

FIG.32shows an example of a vial18having a label that may be read using camera2700, light source2702, and vial spin drive2602. As shown inFIG.32, vial18may include a label3200having a bar code3201and additional information represented in text such as a lot number3202and an expiration date3204. In various circumstances, it may be important to check the lot number and/or the expiration date of a drug in vial18before performing reconstitution or compounding operations. For example, drug recalls can be issued based on lot number. Compounder system10may therefore be configured to read the lot number from each vial placed in vial tray22and to check whether the lot number is associated with a recall prior to using the drug in the vial. In another example, compounder system10may be configured to read the expiration date from each vial placed in vial tray22and to check whether the expiration date has passed (e.g., by comparing the expiration date with the current date).

As shown, a bar code3201may also be provided on label3200. Bar code3201may include coded information related to the drug in the vial such as a manufacturer or a drug name, however, the bar code typically does not include the lot number and expiration date which are printed in text on the label. However, the text size, text color, font, location, and orientation at which the lot number and expiration date are printed on the vial label can vary from drug to drug and from manufacturer to manufacturer.

For example, lot number3202and expiration date3204ofFIG.32are oriented along the x axis (e.g., horizontally on the vial) and offset in the y direction (e.g., vertically offset). However, this is merely illustrative. In various scenarios, lot number3202and expiration date3204may be oriented horizontally and offset horizontally, oriented vertically and offset horizontally, oriented vertically and offset vertically, or otherwise oriented and offset. Moreover, in the example ofFIG.32, lot number3202and expiration date3204are located at the bottom of the label3200. However, this is also illustrative and lot number3202and expiration date3204can be located at various positions on the label. Moreover, lot number3202and expiration date3204may be printed on the label using various fonts, font sizes, font colors, and any of various formats.

For example, inFIG.32, the lot number is indicated using the characters “LOT:” and has a format with numbers and letters separated by hyphens. However, the lot number indicator and format can vary from manufacturer to manufacturer. Similarly, the expiration date is indicated using the characters “EXP:” and has a format of a single string having a 2-digit date, a three-letter month, and a four-digit year. However, the expiration date format can also vary from manufacturer to manufacturer. Due to these variations of the lot number3202and expiration date3204printed on a label disposed on typically rounded vials, compounder system10provides the particular advantage of being able to extract the lot number and expiration date from images of a vial captured while rotating the vial. Further features of the lot number and expiration date extraction systems and methods of compounder system10are discussed hereinafter in connection with the flowcharts ofFIGS.33and34.

Illustrative operations that may be performed for reading a label on a vial in the compounder system10are shown inFIG.33.

At block3300, one or more images may be acquired (captured) from a linescan camera such as camera2700. Camera2700may be configured as a linescan camera by including a line-wise array of image pixels in the camera or by providing a substantially square pixel array and a line-wise illumination source that illuminates a vertical strip on the vial. Capturing the images may include providing a vial having a label in a vial tray of a compounder system, moving the vial, with the vial tray, to an imaging location, rotating the vial while the vial is in the vial tray at the imaging location, and capturing at least one image of the label while rotating the vial.

At block3302, various image processing operations may be performed on the captured images. The image processing operations may include image combination operations in which linescan images are combined to form a rectilinear image of the entire label. The image processing operations may also include applying one or more filters to the linescan images or the combined image (e.g., a cropping filter, a contrast filter, a sharpen filter, a noise filter, or other filters that might facilitate optical character recognition in the images).

At block3304, a label barcode may be read. Reading the label barcode may include reading the label barcode using the image of the label or using a barcode scanner in the compounder.

At block3306, optical character recognition (OCR) operations may be performed to determine a lot number (LOT) and an expiration date (EXP) for the vial from the captured images. The OCR operations may be performed on the whole label image or a portion of the label image in which the lot number and expiration date are expected to appear. The expected location may be determined, for example, based on the barcode. For example, the manufacturer of the drug in the vial may be determined from the barcode. The system (e.g., processing circuitry of the system) may access a database of label information associated with each of various manufacturers. In one example, the system may determine that, for a particular manufacturer, the lot number and expiration date are printed in red text at the bottom of the label in 8 point font and oriented and offset horizontally. The OCR operations may then include performing OCR operations that are informed by the label information (e.g., by searching for characters in 8 point red font, horizontally oriented, and only in a portion of the image at the bottom right corner of the label image). In this way, a compounder system with efficient and accurate verification operations for each vial can be provided.

In some scenarios, the barcode information may be unavailable or non-existent. In such scenarios, the entire image may be searched and used for OCR operations and/or an expected location may be determined based on the known vial type and/or manufacturer (e.g., based on instructions provided by the compounder system to a user to insert an expected vial type or based on a known drug being reconstituted). In some embodiments, when a particular compounder system determines the location, orientation, font size, font, font color, orientation, or other aspects of a label for a particular manufacturer, the system may store that label information for later access and/or may provide the label information to a network of compounder systems for use by those systems in later compounding operations.

At block3308, one or more captured images of the label may be stored and archived as a record of the use of that vial for a particular compounding operation. The images may be archived in connection with identifying information of the receiving container that received a reconstituted drug from the vial.

Further details of operations that may be performed for reading a lot number and/or bar code from a vial label are shown inFIG.34.

At block3400, a vial barcode may be read as discussed herein.

At block3402, a compounder system may determine whether the read barcode is in a database of known barcodes (e.g., a database of the compounder system or a database of a network of compounder systems such as a cloud-based database accessible via a network by multiple compounder systems).

If it is determined at block3402that the barcode is in the database, label information associated with that barcode (e.g., a stored location associated with the known barcode) may be accessed and, at block3406, the system may search for the expiration date and/or lot number at the stored location in a captured label image.

If it is determined at block3402that the barcode is not in the database, at block3404the system may search for the expiration date and/or lot number over the entire captured label image.

At block3408, it may be determined whether the expiration date and lot number read was successful (e.g., whether the expiration date and lot number were read from the label image with a confidence score above a confidence threshold).

If it is determined at block3408that the read was successful, at block3420, in addition to performing compounding operations with the vial if the lot number and expiration date are acceptable, the system may store label information such as updated target text information to a database (e.g., a local database of the compounder system or a network database). At block3422, the system may complete operations for that vial.

If it is determined at block3408that the read was not successful, at block3410, a display of the system may be used to provide the label image to a user and to provide instructions to the user asking the user to highlight an area of the label image having the lot number and/or expiration date using the display screen (e.g., display screen86ofFIG.1orFIG.24).

At block3412, the system may search for the expiration date and/or lot number at the location indicated by the user in the captured label image.

At block3414, it may be determined whether the expiration date and lot number read in the user-specified location was successful (e.g., whether the expiration date and lot number were read from the label image with a confidence score above a confidence threshold).

If it is determined at block3414that the read was successful, at block3420, in addition to performing compounding operations with the vial if the lot number and expiration date are acceptable, the system may store label information such as updated target text information to a database (e.g., a local database of the compounder system or a network database). At block3422, the system may complete operations for that vial.

If it is determined at block3408that the read was not successful, at block3416, the lot number and expiration date may be manually entered by the user (e.g., responsive to a prompt to the user on the display to enter the lot number and expiration date manually).

At block3418, the system may optionally search the image for the text (e.g., the lot number and the expiration date) that the user entered until the entered values are found. The optional additional search may be performed to confirm the user's entry and/or to obtain search and OCR parameters to facilitate future label searches. At block3418, the found values and any search and/or OCR parameters such as image filtering operations used to find the user-entered values may be stored (e.g., locally or on a network database) to facilitate future searches.

The subject technology is illustrated, for example, according to various aspects described above. Various examples of these aspects are described as numbered concepts or clauses (1, 2, 3, etc.) for convenience. These concepts or clauses are provided as examples and do not limit the subject technology. It is noted that any of the dependent concepts may be combined in any combination with each other or one or more other independent concepts, to form an independent concept. The following is a non-limiting summary of some concepts presented herein:

Concept 1. A compounder system, comprising:

a vial tray having a vial opening for receiving a vial containing a drug;a camera;a first motor configured to rotate the vial tray to move the vial to an imaging position;a second motor configured to rotate the vial while the camera captures images of a label on the vial; andprocessing circuitry configured to extract a lot number and an expiration date from the images.
Concept 2. The compounder system of Concept 1 or any other Concept, further comprising a light source configured to illuminate at least a portion of the vial at the imaging position.
Concept 3. The compounder system of Concept 2 or any other Concept, wherein the light source comprises a line-wise light source.
Concept 4. The compounder system of Concept 1 or any other Concept, wherein the processing circuitry is further configured to read a bar code in the images.
Concept 5. The compounder system of Concept 4 or any other Concept, wherein the processing circuitry is further configured to determine an expected location of the lot number and the expiration date based on the bar code.
Concept 6. The compounder system of Concept 5 or any other Concept, wherein the processing circuitry is configured to extract the lot number and the expiration date from the images using the expected location.
Concept 7. The compounder system of Concept 6 or any other Concept, further comprising at least one gear coupled to the second motor, wherein the at least one gear is configured to engage a corresponding gear on a vial puck attached to the vial to rotate the vial.
Concept 8. A method, comprising:providing a vial having a label in a vial tray of a compounder system;moving the vial, with the vial tray, to an imaging location;rotating the vial while the vial is in the vial tray at the imaging location;capturing at least one image of the label while rotating the vial; anddetermining at least one of a lot number and an expiration date from the at least one image.
Concept 9. The method of Concept 8 or any other Concept, wherein moving the vial comprises rotating the vial tray.
Concept 10. The method of Concept 9 or any other Concept, wherein providing the vial in the vial tray comprises placing a vial puck attached to the vial in a vial puck recess in the vial tray.
Concept 11. The method of Concept 8 or any other Concept, wherein capturing the at least one image comprises:capturing a plurality of line scan images while the vial is rotated; andcombining the plurality of line scan images to form a rectilinear image of the entire label.
Concept 12. The method of Concept 8 or any other Concept, further comprising:reading a barcode in the at least one image;obtaining label information associated with the bar code, wherein the label information comprises a location, a text size, and an orientation of the lot number and the expiration date on the label; andperforming optical character recognition operations on a portion of the at least one image corresponding to the location to read the lot number and the expiration date.
Concept 13. The method of Concept 8 or any other Concept, further comprising:following determining the at least one of the lot number and the expiration date from the at least one image, providing a location, a text size, and an orientation of the lot number and the expiration date on the label to a network of compounder systems.
Concept 14. The method of Concept 8 or any other Concept, further comprising determining whether any recalls exist that are associated with the lot number.
Concept 15. The method of Concept 14 or any other Concept, further comprising, if no recalls exist, reconstituting a drug in the vial with the compounder system.
Concept 16. The method of Concept 15 or any other Concept, further comprising archiving the at least one image in association with information for the reconstituted drug.
Concept 17. The method of Concept 8 or any other Concept, further comprising performing image processing operations on the at least one image.
Concept 18. The method of Concept 8 or any other Concept, further comprising, displaying a rectilinear image of the label.
Concept 19. The method of Concept 8 or any other Concept, further comprising storing the lot number in association with a pharmacy tech or an inventory update.
Concept 20. A compounder system, comprising:a carousel support frame configured to rotate a carousel of pump cartridges;a motor mounted to the carousel support frame;a drive mechanism configured to rotate the carousel;a vial tray interposed at least partially between the drive mechanism and the carousel support frame, wherein the drive mechanism is further configured to rotate the vial tray; anda camera, wherein the camera is configured to capture images of a vial in the vial tray while the motor rotates the vial.
Concept 21. The compounder system of Concept 20 or any other Concept, further comprising processing circuitry configured to extract at least one of a lot number and an expiration date from the images.
Concept 22. The compounder system of Concept 21 or any other Concept, further comprising a display, wherein the processing circuitry is configured to (a) prompt a user to select a portion of the images with the lot number or the expiration date and (b) determine the lot number and the expiration date based on the user selected portion of the images.

The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

One or more aspects or features of the subject matter described herein may be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. For example, infusion pump systems disclosed herein may include an electronic system with one or more processors embedded therein or coupled thereto. Such an electronic system may include various types of computer readable media and interfaces for various other types of computer readable media. Electronic system may include a bus, processing unit(s), a system memory, a read-only memory (ROM), a permanent storage device, an input device interface, an output device interface, and a network interface, for example.

Bus may collectively represent all system, peripheral, and chipset buses that communicatively connect the numerous internal devices of electronic system of an infusion pump system. For instance, bus may communicatively connect processing unit(s) with ROM, system memory, and permanent storage device. From these various memory units, processing unit(s) may retrieve instructions to execute and data to process in order to execute various processes. The processing unit(s) can be a single processor or a multi-core processor in different implementations.

A reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent.

As used herein, the phrase “at least one of” preceding a series of items, with the term “or” to separate any of the items, modifies the list as a whole, rather than each item of the list. The phrase “at least one of” does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrase “at least one of A, B, or C” may refer to: only A, only B, or only C; or any combination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa.

In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112 (f) unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.