Patent Description:
The present disclosure generally relates to an apparatus that reconstitutes, mixes, and delivers a drug from a vial to a receiving container. Specifically, the present disclosure relates to dry disconnect features of a closed system automatic drug compounder.

Pharmaceutical compounding is the practice of creating a specific pharmaceutical product to fit the unique need of a patient. In practice, compounding is typically performed by a pharmacist, tech or a nurse who combines the appropriate ingredients using various tools. One common form of compounding comprises the combination of a powdered drug formulation with a specific diluent to create a suspended pharmaceutical composition. These types of compositions are commonly used in intravenous/parenteral medications. It is vital that the pharmaceuticals and diluents are maintained in a sterile state during the compounding process, and there exists a need for automating the process while maintaining the proper mixing characteristics (i.e., certain pharmaceuticals must be agitated in specific ways so that the pharmaceutical is properly mixed into solution but the solution is not frothed and air bubbles are not created). There exists a need for a compounding system that is easy to use, may be used frequently, efficiently, is reliable, and reduces user error.

<CIT> relates to preparing admixtures of parenteral solutions and, more particularly, to a fluid transfer tubing set for transferring individual fluids from multiple supply containers through a positive displacement pumping component to a single receiving container. <CIT> generally relates to solution pumping systems for preparation and administration of patient parenteral solutions, and more particularly to a solution pumping system including a disposable pump cassette configured for efficient and accurate compounding of parenteral solutions, and other applications requiring delivery of multiple reagents or therapeutic agents to a common delivery point. <CIT> relates to a drug container storage device, a drug container storage system, and a method for sucking a drug.

A compounding apparatus with a containment apparatus for a vial is disclosed in <CIT>.

A compounder system may pump diluent from a diluent container to a vial containing a drug, and then pump the reconstituted drug to a receiving container. In order to ensure each medication is correctly and safely reconstituted and moved to the receiving container without mixing of medications or leakage, a disposable cartridge is provided that couples the diluent container and the receiving container to the vial and includes fluid pathways controllable by valves of the cartridge for pumping fluids to and from the vial and the container. A pump component within the cartridge is actuable to move fluid through the controllable fluid pathways.

In order to fluidly couple one or more of the controllable fluid pathways to the vial, the cartridge includes a needle extending from a cartridge body and fluidly coupled to at least one of the controllable fluid pathways. To help ensure dry disconnects, the system may be provided with a vial puck for coupling the cartridge to a vial. The vial puck may include a hydroscopic member to absorb fluid from the needle. The system may include a shuttle valve. The system may also include a filter at an interface between tubing for a receiving container for a medication and a connector for the tubing. The system may also include a syringe pump with a tapered claw feature for gripping and controlling the syringe plunger.

In accordance with various aspects of the disclosure, a compounder system is provided that includes a cartridge having a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port. The cartridge also includes a pump configured to pump a fluid within the plurality of controllable fluid pathways, and a needle configured to couple the plurality of controllable fluid pathways to a vial containing a drug. The compounder system also includes a vial puck configured to attach to the vial. The vial puck comprises a hydroscopic member configured to absorb a portion of the fluid from the needle.

In accordance with other aspects of the disclosure, a compounder system is provided that includes a cartridge having a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port, a connector a receiving container, tubing extending from the receiving container port of the cartridge to the connector, and a filter disposed at an interface between the connector and the tubing.

In accordance with other aspects of the disclosure, a compounder system is provided that includes a cartridge having a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port, and a pump configured to pump a fluid within the plurality of controllable fluid pathways. The at least one diluent port comprises a female portion of a dry disconnect shuttle valve.

In accordance with other aspects of the disclosure, a compounder system is provided that includes a cartridge having a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port, and a syringe pump configured to pump a fluid within the plurality of controllable fluid pathways, wherein the syringe pump comprises a syringe plunger having a tapered grasping handle.

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> illustrates a compounder system <NUM> according to an embodiment. <FIG> illustrates the system <NUM> with a transparent outer housing <NUM> and <FIG> illustrates the system with the housing removed. The system comprises a carousel assembly <NUM> that contains up to <NUM> individual cartridges <NUM>. The carousel <NUM> can hold more or less cartridges <NUM> if desired. The cartridges <NUM> are disposable and provide unique fluid paths between a vial <NUM> containing a powdered drug (or concentrated liquid drug), multiple diluents, and a receiving container. The cartridges <NUM> may, 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 assembly <NUM> is mounted on the apparatus such that it can rotate to bring different cartridges <NUM> into alignment with the pump drive mechanism <NUM>. The carousel <NUM> is typically enclosed within a housing <NUM> that can be opened in order to replace the carousel <NUM> with a new carousel <NUM> after removing a used one. As illustrated, the carousel <NUM> can contain up to <NUM> cartridges <NUM>, allowing a particular carousel to be used up to <NUM> times. In this configuration, each carousel assembly can support, for example, <NUM> to <NUM> 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 <NUM> receiving containers. The housing <NUM> also includes a star wheel <NUM> positioned underneath the carousel <NUM>. The star wheel <NUM> rotates vials <NUM> of pharmaceuticals into position either in concert with, or separate from, the specific cartridges <NUM> on the carousel <NUM>. The housing <NUM> may also include an opening <NUM> for loading the vials <NUM> into position on the star wheel <NUM>.

Each one of the cartridges <NUM> in the carousel <NUM> is a disposable unit that includes multiple pathways for the diluent and vapor waste. These pathways will be described in detail with reference to, for example, <FIG> et seq. Each cartridge <NUM> is 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 cartridge <NUM> also may include a pumping mechanism such as a piston pump for moving fluid and vapor through the cartridge <NUM> as well as a dual lumen needle in a housing that can pierce a vial puck <NUM> on top of a vial <NUM> once the vial <NUM> has been moved into position by the pump drive mechanism <NUM>. For example, the needle may pierce the vial puck <NUM> via the compressive action of the vial puck <NUM>, which is moved towards the needle. Each cartridge <NUM> also includes a plurality of ports designed to match up with the needles of a plurality of diluent manifolds. Each cartridge <NUM> also includes openings to receive mounting posts and a locking bayonet from the pump head assembly <NUM>. 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 cartridge <NUM> also includes openings allowing valve actuators from the pump motor mechanism to interact with the valves on each cartridge <NUM>.

Adjacent the housing <NUM> that holds the vials <NUM> and the carousel <NUM> is an apparatus <NUM> for holding at least one container <NUM>, such as an IV bag <NUM> as shown in the figures. The IV bag <NUM> typically has two ports such as ports <NUM> and <NUM>. For example, in one implementation, port <NUM> is an intake port <NUM> and port <NUM> is an outlet port <NUM>. Although this implementation is sometimes discussed herein as an example, either of ports <NUM> and <NUM> may be implemented as an input and/or outlet port for container <NUM>. For example, in another implementation, an inlet <NUM> for receiving a connector at the end of tubing <NUM> may be provided on the outlet port <NUM>. In the embodiment shown, the IV bag <NUM> hangs from the holding apparatus <NUM>, which, in one embodiment is a post with a hook as illustrated in <FIG>. As discussed in further detail hereinafter, 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 apparatus <NUM> can take any other form necessary to position the IV bag <NUM> or other pharmaceutical container. Once the IV bag <NUM> is positioned on the holding apparatus <NUM>, a first tube <NUM> (a portion of which is shown in <FIG>) is connected from a cartridge <NUM> on the carousel <NUM> to the inlet <NUM> of the IV bag <NUM>. 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 bag <NUM>. A connector <NUM> such as a Texium® connector may be provided on the end of tube <NUM> for connecting to inlet <NUM> of receiving container <NUM>.

On the opposite side of the compounder <NUM> is an array of holding apparatuses <NUM> for holding multiple IV bags <NUM> or other containers. In the illustrated version of the compounder <NUM>, five IV bags <NUM>, <NUM> are pictured. Three of these bags <NUM> may contain diluents, such as saline, D5W 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 bag <NUM> for collecting waste such as potentially hazardous or toxic vapor waste from the mixing process. An additional bag <NUM> may 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. As discussed in further detail hereinafter, 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 containers <NUM> and <NUM> may each be connected to a cartridge <NUM> through a disposable manifold.

The compounding system <NUM> also includes a specialized vial puck <NUM> designed to attach to multiple types of vials <NUM>. In operation, the vial puck <NUM> is placed on top of the vial <NUM> containing the drug in need of reconstitution. Once the vial puck <NUM> is in place, the vial <NUM> is loaded into the star wheel <NUM> of the compounder <NUM>. Mating features on the vial puck <NUM> provide proper alignment both while the vial puck <NUM> is in the star wheel <NUM> and when the vial puck <NUM> is later rotated into position so that the compounder <NUM> can remove it from the star wheel <NUM> for further processing.

The pump drive mechanism <NUM> is illustrated in <FIG>, and in an exploded view in <FIG>, according to an embodiment. In the embodiment shown in <FIG> and <FIG>, the pump drive mechanism <NUM> comprises a multitude of sections. At one end of the pump drive mechanism <NUM> is the rotation housing <NUM>, which holds the drive electronics and includes locking flanges <NUM> on its housing <NUM> for flexible tubing <NUM> which may run from one or more diluent containers and/or waste containers to one or more corresponding manifolds. The rotation housing <NUM> is capable of rotating around its axis to rotate the rest of the pump drive mechanism <NUM>. The rotation housing <NUM> includes bearing ribs <NUM> on 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 <NUM>°, or more than <NUM>°.

The compounder system also includes a diluent magazine that mounts in a slot <NUM> located 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 may be modular so they can easily and removably connect to each other, the magazine, and/or connect to the pump drive mechanism <NUM>.

Pump drive mechanism <NUM> also includes pump head assembly <NUM>. The pump head assembly <NUM> includes the vial grasping arms <NUM>, the vial lift <NUM>, the pump cartridge grasp <NUM>, the pump piston eccentric drive shaft <NUM> with drive pin <NUM>, the valve actuation mechanisms <NUM>, as well as the motors that allow the pump drive mechanism <NUM> to move forward and back and to rotate in order to mix the pharmaceutical in the vial <NUM> once the diluent has been added to it. The compounder <NUM> may also include an input screen <NUM> such as a touch screen <NUM> as shown in the figures to provide data entry by the user and notifications, instructions, and feedback to the user.

The operation of the compounder system <NUM> will now be generally described in the flowchart illustrated at <FIG>, according to an embodiment. In the first step <NUM>, a user inserts a new diluent manifold magazine having a plurality of manifolds (e.g., diluent manifolds and waste manifolds) into the slot <NUM> on the side of the pump head assembly <NUM>. Manifolds may be loaded into the magazine before or after installing the magazine in the slot <NUM>. The manifolds maintain needles inside the housing of the manifold until the cartridge <NUM> is 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 step <NUM>, 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 of <FIG>, the tubes are held in place with locking flanges <NUM> on 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 of <FIG>, the additional flanges <NUM> positioned on the outside housing <NUM> of the pump drive mechanism <NUM> are provided for securing internal wiring of the compounder. In the next step <NUM>, waste tubing may be connected to the vapor waste bag <NUM>. 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 steps <NUM> and <NUM> may be omitted.

If desired, in the next step <NUM>, a new carousel <NUM> may be loaded into a carousel mounting station such as a carousel hub of the compounder system. The carousel <NUM> may contain any number of disposable cartridges <NUM> arranged in a generally circular array. In the next step <NUM>, a vial puck <NUM> is attached to the top of a vial <NUM> of a powdered or liquid pharmaceutical for reconstitution and the vial <NUM> is loaded into the star wheel <NUM> under the carousel <NUM> in the next step <NUM>. Step <NUM> may include loading multiple vials <NUM> into multiple vial puck recesses in star wheel <NUM>. 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 step <NUM> is for a user to select the appropriate dosage on the input screen.

After the selection on the input screen <NUM>, the compounder <NUM> begins operation <NUM>. The star wheel <NUM> rotates the vial into alignment <NUM> with the vial grasping calipers <NUM> of the pump head assembly <NUM>. The vial puck <NUM> includes, for example, gears that interface with gears coupled to a rotational motor that allow the vial <NUM> to rotate <NUM> so that a scanner (e.g., a bar code scanner or one or more cameras) can scan <NUM> a label on the vial <NUM>. 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 and/or recall or other instructions associated with the lot number. Once the vial <NUM> is scanned and aligned, in the next step <NUM> the pump drive mechanism <NUM> moves forward into position to grip the vial <NUM> with the calipers <NUM>. The forward movement also brings the mounting posts <NUM> and locking bayonet <NUM> on the front of the pump head assembly <NUM> into matching alignment with corresponding openings on a cartridge <NUM>. In the next step <NUM> the cartridge <NUM> is locked in place on the pump head assembly <NUM> with the locking bayonet <NUM> and the calipers <NUM> grip <NUM> the vial puck <NUM> on the top of the vial <NUM>. The calipers <NUM> then remove <NUM> the vial <NUM> from the star wheel <NUM> by moving backward, while at the same time pulling <NUM> the cartridge <NUM> off of the carousel <NUM>.

In some embodiments, the cartridge <NUM> includes a backpack that includes a coiled tube. In this embodiment, in step <NUM> the pump drive mechanism <NUM> tilts the cartridge <NUM> toward the user to expose the end of the tube and prompts <NUM> the user to pull the tube out of the backpack and connect it to the receiving bag <NUM>. In an alternative embodiment, the tube <NUM> is exposed on the side of the carousel <NUM> once the cartridge <NUM> is pulled away from the carousel <NUM>. In another alternative embodiment, the tube <NUM> is 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 prompts <NUM> the user to pull the tube out from the carousel <NUM> and connect it to the input <NUM> of the IV bag <NUM>. Once the tube <NUM> is connected, in step <NUM> the user may notify the compounder <NUM> to continue the compounding process by interacting with the input screen <NUM>.

At step <NUM>, the vial <NUM> is pulled up towards the cartridge <NUM> so that one or more needles such as a coaxial dual lumen needle of the cartridge <NUM> pierce the top of the vial puck <NUM> and enter the interior of the vial <NUM>. Although the example of <FIG> shows 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, steps <NUM> and <NUM> may be performed after step <NUM> such 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 pumped at step <NUM> into the vial <NUM> through the cartridge <NUM> and a first needle in the proper dosage. If necessary, a second or third diluent may be added to the vial <NUM> via a second or third diluent manifold attached to the cartridge <NUM>. Simultaneously, vapor waste is pumped <NUM> out of the vial <NUM>, through a second needle, through the cartridge <NUM> and the vapor waste manifold, and into the vapor waste bag <NUM>. The valve actuators <NUM> on the pump head assembly <NUM> open and close the valves of the cartridge <NUM> in order to change the fluid flow paths as necessary during the process. Once the diluent is pumped into the vial <NUM>, the pump drive mechanism <NUM> agitates the vial <NUM> in the next step <NUM> by rotating the vial lift <NUM> up to, for example <NUM> degrees such that the vial <NUM> is 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 <NUM> 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 container <NUM> may 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 step <NUM>, the valve actuators <NUM> reorient the valves of the cartridge and the pumping mechanism of the cartridge <NUM> is activated to pump <NUM> the reconstituted drug into the receiving bag <NUM> through the attached tube. Once the drug is pumped into the receiving bag <NUM>, in the next step <NUM> the pump drive mechanism <NUM> clears the tube <NUM> by either pumping filtered air or more diluent through the tube <NUM> into the receiving bag <NUM> after another valve adjustment to ensure that all of the reconstituted drug is provided to the receiving bag <NUM>. In some scenarios, a syringe may be used as a receiving container <NUM>. In scenarios in which a syringe is used as the receiving container <NUM>, following delivery of the reconstituted drug to the syringe, a vacuum may be generated in tube <NUM> by pump drive mechanism <NUM> to remove any air or other vapors that may have been pushed into the syringe so that, when the syringe is removed from tube <NUM>, the reconstituted drug is ready for delivery to a patient and no air or other unwanted gasses are present in the syringe.

The system then prompts <NUM> the user to remove the tube <NUM> from the receiving container <NUM>. 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 carousel <NUM> or the backpack, depending on which type of system is in use. In the next step <NUM>, the compounder <NUM> rotates the vial <NUM> back into alignment with the star wheel <NUM> and releases it. The used cartridge <NUM> may also be replaced on the carousel <NUM>. 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 carousel <NUM> and/or star wheel <NUM> then may rotate <NUM> to a new unused cartridge <NUM> and/or a new unused vial <NUM> and 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 cartridges <NUM> are designed to be disposable, allowing a user to utilize all the cartridges <NUM> in a given carousel <NUM> before replacing the carousel <NUM>. After a cartridge <NUM> is used, the carousel <NUM> rotates to the next cartridge <NUM>, and the system software updates to note that the cartridge <NUM> has been used, thus preventing cross-contamination from other reconstituted drugs. Each cartridge <NUM> is 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 cartridge <NUM>, its flow paths, and its valve construction.

An embodiment of a cartridge <NUM> is illustrated in <FIG>. As shown in <FIG>, cartridge <NUM> may include a cartridge frame <NUM>, a cartridge bezel <NUM>, as well as a piston pump <NUM>, a needle housing <NUM> and a needle assembly <NUM>. The cartridge frame <NUM> provides the main support for each cartridge <NUM> and 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 container <NUM>.

The frame <NUM> of the cartridge <NUM> also includes locating features that allow each cartridge <NUM> to be removably mounted to the pump head assembly <NUM>. These features include, for example, three openings <NUM> to receive mounting posts <NUM> from the pump head assembly <NUM>, and a keyhole <NUM> that allows a locking bayonet <NUM> to be inserted therein and turned to lock the cartridge <NUM> to the pump head assembly <NUM> for removal from the carousel <NUM>. An outlet port extension <NUM> may be present in some embodiments. The piston pump <NUM> is mounted within a chamber with a rod <NUM> positioned within a silicone piston boot. Furthermore, the bezel <NUM> includes openings <NUM> in which the valves <NUM> of the sealing membrane are located and be accessed by the valve actuators <NUM>. Moreover, the bezel <NUM> includes openings <NUM> that allow a fluid manifold to be connected to the diluent and vapor waste chambers in the cartridge <NUM>. As discussed in further detail hereinafter, bezel <NUM> may 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 openings <NUM> in the bezel <NUM> and pierce the sealing membrane to gain fluidic access to the diluent and vapor waste chambers defined in the cartridge <NUM> between the sealing membrane and the cartridge frame <NUM>. Further details of various embodiments of the cartridge <NUM> will be discussed hereinafter.

Referring to <FIG>, an exemplary embodiment of a carousel <NUM> removed from the compounder <NUM> is illustrated, according to an embodiment. The carousel <NUM> of <FIG> includes an array of ten cartridges <NUM> in this embodiment, but it should be understood that more or fewer cartridges <NUM> can be present on the carousel <NUM>, leaving some of the carousel <NUM> pockets <NUM> empty, or the frame <NUM> of the carousel can be designed to have more or fewer cartridge pockets <NUM>. In some implementations, the carousel <NUM> may also, optionally, include a cover <NUM> that prevents a user from accessing the tubes coupled to each of the cartridges <NUM> directly. In these implementations, the cover <NUM> may be removed if necessary to access the backs of the cartridges <NUM>. In the example implementation of <FIG>, a connector such as a Texium® attachment <NUM> is disposed adjacent each cartridge <NUM>, the attachment <NUM> being attached to the tube <NUM> that runs from the extension <NUM> on each cartridge <NUM>.

<FIG> show the compounder <NUM> according to another embodiment. As shown in <FIG>, holding apparatus <NUM> may be implemented as an extended arm providing support for mounting devices for each of containers <NUM> and <NUM>. Holding apparatus <NUM> and holding apparatus <NUM> may 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 scanner <NUM> may be provided with which each diluent container and/or the receiving container can be scanned before and/or after attachment to compounder <NUM>. As shown in <FIG>, a carousel cover <NUM> and tube management structures <NUM> may also be provided on compounder <NUM> in various embodiments. For example, tubes connected between containers <NUM> and/or <NUM> and corresponding manifolds can each be mounted in a groove of tube management structure <NUM> to prevent tangling or catching of the tubes during operation of compounder <NUM>.

An opening may be provided by which vials <NUM> can be installed in the star wheel. Additionally, an exterior pump <NUM> may be provided for pumping non-toxic liquid waste from, for example, receiving container <NUM> to a waste container <NUM> (e.g., for pumping a desired amount of saline out of receiving container <NUM> quickly and without passing the liquid waste through a cartridge and/or other portions of the compounder).

A fluidics module <NUM> may be provided that includes several container mounts which may 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 compounder <NUM> can 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 in <FIG>, pump <NUM> and display <NUM> may be mounted to a chassis <NUM>. Pump drive <NUM> may be mounted partially within the chassis <NUM> with pump head assembly <NUM> extending from the chassis to a position which allows the pump head assembly to rotate (e.g., to turn over or agitate a vial). Carousel <NUM> is also shown in <FIG> without any cartridges mounted therein so that cartridge mounting recesses <NUM> can be seen.

Star wheel <NUM> (sometimes referred to herein as a vial tray) is shown in <FIG> with several empty vial puck recesses <NUM>. Vial tray <NUM> may be rotated and an actuating door <NUM> may be opened to facilitate loading of vials <NUM> into the vial puck recesses <NUM> in vial tray <NUM>. In some embodiments, door <NUM> may be closed before rotation of vial tray <NUM> to 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 sensor <NUM> (e.g., a light curtain) may be provided instead of (or in addition to) door <NUM> to sense the presence of an operator in the vicinity of tray <NUM> and prevent rotation of the tray if the operator or any other obstruction is detected.

Similarly, a lid may be provided for carousel <NUM> to prevent contamination of cartridges <NUM> loaded 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 carousel <NUM> may be prevented if the lid is not detected in a closed position by the lid sensor.

Each vial <NUM> that is inserted may be detected using a sensor such as sensor <NUM> (e.g., a load sensor or an optical sensor) when placed in a vial puck recess <NUM>. When detected, the inserted vial may be moved to a scanning position by rotating vial tray <NUM> and then the inserted vial <NUM> may be rotated within its position in vial tray <NUM> using a vial rotation motor <NUM> to allow the vial label to be scanned.

A reverse perspective view of compounder <NUM> is shown in <FIG> in which scanning components can be seen. In particular, a camera <NUM> is mounted in an opening in chassis <NUM> and configured to view a vial <NUM> in a scanning position. Motor <NUM> may rotate vial <NUM> through one or more full rotations so that camera <NUM> can capture images of the vial label. In some embodiments, an illumination device <NUM> (e.g., a light-emitting diode or other light source) may be provided that illuminates vial <NUM> for imaging with camera <NUM>.

As shown in <FIG> one or more gears <NUM> coupled to motor <NUM> may be provided that engage corresponding gears on a vial puck <NUM> to which a vial <NUM> is attached at the scanning position. The vial tray <NUM> may be rotated so that the vial puck gears engage the rotation motor gears so that when the motor <NUM> is operated the vial <NUM> is rotated.

<FIG> also shows how a magazine <NUM> containing one or more manifolds may be mounted in a recess in pump head assembly <NUM>. A magazine slot in magazine <NUM> for 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 magazine <NUM> may have a common geometry and thus any diluent manifold can fit in the magazine diluent slots. One or more manifold sensors such as manifold sensor <NUM> (e.g., an optical sensor) may be provided in the manifold recess in pump head assembly <NUM>. Manifold sensor <NUM> may be configured to detect the presence (or absence) of a manifold in a manifold recess (slot) in magazine <NUM> to 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 components <NUM> such as valve actuators, needle actuators, mounting posts, a locking bayonet, and a drive pin can also be seen extended from pump head assembly <NUM> which are configured to secure and operate a pump cartridge <NUM>.

Compounder <NUM> may include additional components such as a chassis base and chassis housing, and an internal electronics assembly. Pump drive <NUM> may be seated in an opening in the chassis housing that allows pump head assembly <NUM> to protrude from the chassis housing. Processing circuitry for managing operations of compounder system <NUM> may be included in the electronics assembly.

Carousel <NUM> may be placed onto a carousel hub and rotated by a vial tray and carousel drive assembly operating to rotate the hub to move a selected cartridge in the carousel into position to be retrieved and operated by pump drive <NUM>. The vial tray and carousel drive assembly may include separate drive assemblies for the vial tray and for the carousel such that vial tray <NUM> and carousel <NUM> may be rotated independently.

<FIG> shows another perspective view of compounder <NUM> highlighting the locations of various particular components such as the carousel <NUM> with cartridges <NUM> mounted therein, a cartridge <NUM> having a backpack <NUM>, a vial puck <NUM> for mounting vials <NUM>, and pump head assembly <NUM> with a diluent magazine <NUM> containing a plurality of manifolds <NUM> in accordance with an embodiment. Further features of compounder <NUM> will be described hereinafter in connection with FIGS. <NUM>-<NUM> in accordance with various embodiments.

The cartridges <NUM> are designed to be disposable, allowing a user to utilize all the cartridges <NUM> in a given carousel <NUM> before replacing the carousel <NUM>. After a cartridge <NUM> is used, the carousel <NUM> rotates to the next cartridge <NUM>, and the system software updates to note that the cartridge <NUM> has been used, thus preventing cross-contamination from other reconstituted drugs. Each cartridge <NUM> is designed to contain all the necessary flow paths, valves, filters, pistons, 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 he proper amount of drug and diluent is present in the receiving container. The amount of diluent pumped into vials for reconstitution and the amount of medication pumped out of vials to the receiving container are controlled by the volumetric piston pump in the cartridge which can be compared against weights obtained by the gravimetric scales (e.g., one or more diluent load cells and a receiving container load cell) of the compounder for quality control. This complete package is made possible by the specific and unique construction of the cartridge <NUM>, its flow paths, and its valve construction.

Various embodiments of a cartridge <NUM> are illustrated in <FIG>. A fully constructed cartridge <NUM> is shown in <FIG> and <FIG> in one embodiment. A cartridge <NUM> having a tube management structure implemented as a backpack for the cartridge is shown in <FIG> and <FIG>. An exploded version of a cartridge <NUM> is illustrated in <FIG> and shows three main portions of the cartridge <NUM>: the cartridge frame <NUM>, the cartridge sealing membrane <NUM>, the cartridge bezel <NUM>, as well as the piston pump <NUM>, the needle housing <NUM> and the needle assembly <NUM> according to an embodiment. A fully constructed cartridge <NUM> is shown in <FIG> and <FIG> in one embodiment. Various features of the cartridge of <FIG>, <FIG>, and <FIG> are shown in <FIG>.

As shown in <FIG>, a front view of the cartridge <NUM> is illustrated. Cartridge frame <NUM> provides the main support for each cartridge <NUM>. Piston pump <NUM> and a cartridge needle housing <NUM> to hold the needle assembly <NUM> are provided that can be operated to move liquids and waste vapor to and from vial <NUM> during reconstitution and filling of receiving container <NUM>. Valves <NUM> are positioned with respect to various internal flow paths within cartridge <NUM> for diluents, vapor waste, filtered air, and reconstituted drugs and are operable to modify and control the internal flow paths when desired.

Frame <NUM> of the cartridge <NUM> also includes locating features that allow each cartridge <NUM> to be removably mounted to the pump head assembly <NUM>. These features include three openings <NUM> to receive mounting posts <NUM> from the pump head assembly <NUM>, and a keyhole <NUM> that allows a locking bayonet <NUM> to be inserted therein and turned to lock the cartridge <NUM> to the pump head assembly <NUM> for removal from the carousel <NUM>.

The cartridge needle housing <NUM> extends from the bottom of the cartridge frame <NUM> and may be designed to be removable by snapping a pair of locking flanges <NUM> on the needle housing <NUM> into flange openings <NUM> in the cartridge frame <NUM>. The cartridge needle housing <NUM> is designed to prevent accidental user contact with the needle assembly <NUM> and to maintain the sterility of one or more needles of the needle assembly (see, e.g., needles <NUM> and <NUM> of <FIG>). The needle housing <NUM> also receives the vial puck <NUM> in a position to allow the needles to pierce the vial puck <NUM>.

A sealing membrane may be disposed between frame <NUM> and bezel <NUM> to form sealed internal flow paths in cartridge <NUM> in cooperation with internal features of frame <NUM> and bezel <NUM> as described in further detail hereinafter.

Before describing the various fluid flow paths in the cartridge <NUM>, the operation of the pumping and valve mechanisms will be described with reference to <FIG>, <FIG>, <FIG> and <FIG>. A piston pump such as piston pump <NUM> acts as a positive displacement pump that has significant advantages over a traditional peristaltic pump mechanism. First, it has the best rate accuracy and flow continuity regardless of the pump's orientation or environmental conditions. Second, it is able to push an excess of <NUM> psi into elastomeric pumps. The piston pump <NUM> may be positioned within the cartridge <NUM> in a silicone piston pump boot. The pump mechanism is driven by a motor in the pump motor mechanism <NUM> which rotates an eccentric drive shaft <NUM> and drive pin <NUM> on the pump head assembly <NUM> which controls the movement of the piston <NUM> as well as the valve actuators <NUM>. In operation, the cartridge <NUM> is placed on the cartridge grasp <NUM> on the locating posts <NUM> and locked in place by the locking bayonet <NUM>. This aligns the valves disposed in openings <NUM> of bezel <NUM> with the valve actuators <NUM> and the eccentric drive shaft <NUM> and pin <NUM> with the piston pump <NUM>. The piston <NUM> is driven by the eccentric drive pin <NUM>. The pin <NUM> is parallel to but offset from the rotational axis of the drive shaft, which produces sinusoidal motion that is converted to an axial movement of the piston <NUM>.

The valve actuators <NUM> are illustrated in <FIG> and <FIG>, which show the pump head assembly <NUM> removed from the rest of the pump motor mechanism <NUM>. Each one of the valves in openings <NUM> has a corresponding valve actuator <NUM> that is controlled by a geared cam to cause axial movement of the valve actuator <NUM> into contact with the valve to close the valve and away from the valve to open the valve. In one embodiment, eight valve actuators <NUM> are provided, one for each valve, and they are aligned with the positions of the valves so they can extend through the openings <NUM> in the bezel <NUM> of the cartridge <NUM> and contact the valves. The valve actuators <NUM> are software controlled so that they can automatically cause the valves to open and close depending on which internal flow paths within cartridge <NUM> are to be opened and closed.

The valve actuators <NUM> are operated at different times in the pumping cycle depending on the required fluid flow path. The fill portion of the piston <NUM> starts as the piston rod <NUM> moves, and the inlet valve is opened and the outlet valve is closed. Other valves will be opened and closed depending on the necessary fluid flow paths. At the end of the fill portion of the cycle when the piston <NUM> is at the bottom dead center position, the valve actuation changes to close the inlet and open the outlet valves. At this point, the delivery portion of the cycle starts and the piston <NUM> moves in the opposite direction. The delivery portion of the cycle ends when the piston <NUM> reaches the top dead center location, which is the home location. When the piston <NUM> reaches this position, a new cycle is started.

The movement of the eccentric drive shaft <NUM> can be in a clockwise direction under normal conditions when delivering fluid and counter clockwise when pulling fluid. The pump mechanism can be made to pump backwards depending on the required flow path. The drive may be prevented from being inadvertently back driven in either direction by the effects of pressure in the disposable line up to <NUM> psi.

An alternative embodiment of the cartridge <NUM> utilizing a "backpack" to coil the flexible tubing <NUM> is illustrated in <FIG> and <FIG>. The backpack <NUM> is attached to the back of the cartridge frame <NUM> and one end of the flexible tube <NUM> is attached to an outlet port on the back of the cartridge frame <NUM>. The backpack <NUM> comprises a housing <NUM> and may include a tube control mechanism defined in a chamber that can rotate or otherwise operate to coil the flexible tubing <NUM>. At the opposite end of the tubing from the outlet port is a connector <NUM> (e.g., an ISO Luer connector such as a Texium® attachment) that a user can pull out of the backpack <NUM> and attach to the receiving bag <NUM>. In some embodiments, the tubing attached to the connector <NUM> may be automatically extended from within backpack <NUM> to facilitate attachment by the user. Upon completion of the filling of the bag <NUM>, the tube control mechanism can draw the flexible tubing <NUM> back into the backpack <NUM> and out of the way so that the next cartridge <NUM> in the carousel <NUM> can be utilized. Retraction of the flexible tubing may be automatic once the ISO Luer is placed into the opening in the backpack.

Turning now to <FIG>, an exploded perspective view of another embodiment of cartridge <NUM> shows three main portions of the cartridge <NUM>: the cartridge frame <NUM>, the cartridge sealing membrane <NUM>, the cartridge bezel <NUM>, as well as the piston pump <NUM>, the needle housing <NUM> and the needle assembly <NUM>. In the example of <FIG>, cartridge bezel <NUM> includes an additional opening <NUM> to provide access to a pressure dome formed on membrane <NUM> to allow sensing of pressure in the fluid pathways of cartridge <NUM>. An air-in-line sensor fitment <NUM> is also provided that is configured to mate with an air-in-line (AIL) sensor in the compounder.

In order to control the flow of gasses such as vapor waste and sterile air within the cartridge, cartridge <NUM> may be provided with gas flow control structures such as an air filter <NUM> and one or more check valve discs <NUM> that mount to frame <NUM> with a check valve cover <NUM>. Air filter <NUM>, check valve discs <NUM>, and check valve cover <NUM> may cooperate to allow vapor waste to flow in only one direction from the vial to the waste port and to allow sterile (filtered) air to flow in only one direction into the cartridge from a vent adjacent the air filter to the vial. In this way, unwanted vapor waste may be prevented from flowing out of the pump cartridge and may be instead guided to a vapor waste container.

As shown in <FIG>, piston <NUM> may include a piston boot <NUM> that, for example, provides one or more moveable seals (e.g., two moveable seals) for controlling the volume of a pump chamber when piston <NUM> is actuated. <FIG> also shows various structures for control of another embodiment of needle housing <NUM> in which needle assembly <NUM> includes a dual lumen needle with a first needle overmold 317A, a second needle overmold 317B, a needle spring <NUM>, and a needle membrane <NUM>. An opening <NUM> in bezel <NUM> may be provided that aligns with a corresponding opening <NUM> in frame <NUM> to allow a view through cartridge <NUM> (e.g., by a sensor of the pump drive mechanism) into a backpack that is mounted to cartridge <NUM> as will be described in further detail hereinafter. A protrusion <NUM> formed on a top side of cartridge frame <NUM> may be provided as a mounting structure for the backpack.

<FIG> and <FIG> show assembled views of the cartridge embodiment shown in <FIG> from the bezel side and frame side respectively in which an opening <NUM> (formed by openings <NUM> and <NUM> of <FIG>) that allows a view completely through cartridge <NUM> can be seen. As shown in <FIG>, in some embodiments, cartridge <NUM> may include four diluent and waste ports <NUM> and a pressure dome <NUM>. For example, three of the ports <NUM> may be configured as diluent ports and one of the ports <NUM> may be configured as a waste port. A pressure sensor in the pump head assembly <NUM> may determine pressure within the fluid pathways in cartridge <NUM> by contacting pressure dome <NUM>. Each of the ports <NUM> may be formed from an opening in bezel <NUM> and a chamber located behind a portion of membrane <NUM> in frame <NUM>.

<FIG> is a cross-sectional perspective side view of an assembled cartridge <NUM> having a backpack <NUM> (e.g., an implementation of backpack <NUM> of <FIG>) attached thereto to form a cartridge and backpack assembly <NUM>. As shown in <FIG>, protrusion <NUM> may extend into an opening <NUM> in the backpack <NUM> to latch the backpack to cartridge <NUM> at the top side. Additional latching structures at the bottom side will be described in further detail hereinafter. An additional structure <NUM> may be disposed between backpack <NUM> and cartridge <NUM>. Structure <NUM> may be substantially planar and may be shaped and positioned to latch cartridge and backpack assembly <NUM> to carousel <NUM>. For example, protrusions <NUM> that extend from the top of the backpack <NUM> may be actuatable to facilitate installation and removal of the cartridge and backpack assembly into and out of the carousel. For example, ramp structures on the carousel may compress protrusions <NUM> when cartridge and backpack assembly <NUM> is pushed into the carousel until protrusions <NUM> snap up into a locked position to secure the cartridge and backpack assembly in the carousel. To remove cartridge and backpack assembly <NUM> from the carousel for compounding operations, a bayonet <NUM> that extends into opening <NUM> may be turned to lower protrusions <NUM> to release the cartridge and backpack assembly from the carousel. Further features of the coupling of cartridge and backpack assembly <NUM> to the carousel will be described hereinafter.

Tubing (e.g., flexible tubing <NUM>) for fluidly coupling cartridge <NUM> to a receiving container <NUM> may be housed within backpack <NUM>. For example, the tubing may be coupled at an output port <NUM> (e.g., a receiving container port - see, e.g., <FIG>) to cartridge <NUM>, coiled within an internal cavity of backpack <NUM>, and extend through opening <NUM> so that an end of the tubing can be pulled by an operator to extend the tubing for coupling to the receiving container. An additional opening <NUM> may be provided within which a connector such as a Texium® connector coupled to the end of the tubing can be stored when the cartridge and backpack assembly is not in use. When instructed (e.g., by onscreen instructions on display <NUM>) an operator may remove the connector from opening <NUM>, pull the tubing from within backpack <NUM>, and connect to the connector to a receiving container. For example, processing circuitry of the compounder system may provide instructions, using the display, to (a) remove a connector that is coupled to the tubing from an additional opening in the backpack, (b) pull the tubing from the backpack, and (c) connect the connector to the receiving container. In another embodiment, extension of the flexible tubing is automatic (e.g., software determines the precise moment the flexible tube should be extended, the pump head operates screw mechanism to extend the tubing, and a signal to the user to pull the ISO Luer out of the backpack opening is provided). Compounder <NUM> may include a sensor such as an optical sensor that determines whether the connector is present within opening <NUM> (e.g., by viewing the connector through opening <NUM>).

Compounder <NUM> may determine, based on whether the connector is within opening <NUM>, whether and when to release the cartridge and backpack assembly from the pump head assembly. For example, following compounding operations, an operator may be instructed to remove the connector from the receiving container and return the connector into opening <NUM>. Backpack <NUM> may include features and components for facilitating the storage and extraction of the tubing from within the internal cavity. When the connector is detected in opening <NUM>, the pump drive mechanism <NUM> may operate one or more coiling mechanisms within backpack <NUM> to pull the extended tubing back into the backpack and may turn the bayonet to lower protrusions <NUM> so that the cartridge and backpack assembly can be returned to the carousel.

<FIG> also shows an enlarged view of a portion of cartridge <NUM> with the cross-section taken through two of valves <NUM> within openings <NUM> in bezel <NUM>. As shown in the enlarged view, each valve <NUM> may be formed from a raised portion <NUM> of sealing membrane <NUM> that extends from a planar portion <NUM> of sealing membrane <NUM> into a corresponding opening <NUM> in cartridge bezel <NUM>. In the example shown in, for example, <FIG>, raised portion <NUM> is a pyramid-shaped dome formed in opening <NUM>. In a portion of the fluid path <NUM> formed between sealing membrane <NUM> and frame <NUM> adjacent each valve <NUM>, frame <NUM> may include a rib <NUM> in spaced opposition to the raised portion <NUM> of the sealing membrane for that valve. When raised portion <NUM> is in a raised position, fluid and/or vapor can flow over rib <NUM> through the open valve. In operation, a valve actuator <NUM> that extends from and is operable by pump head assembly <NUM> can extend through opening <NUM> to compress raised portion <NUM> against rib <NUM> to close the valve and prevent fluid from flowing therethrough.

<FIG> is a cross-sectional side view of the cartridge showing piston pump <NUM>. As shown in <FIG>, piston pump <NUM> may include a silicon boot <NUM> having first and second seals <NUM> and <NUM>. Forward seal <NUM> may form a moving boundary of a pump chamber <NUM>. Rearward seal <NUM> may prevent dust or other contaminants from contacting forward seal <NUM>. Pump chamber <NUM> may be formed adjacent one or more valves <NUM> (e.g., a pair of valves may be disposed on opposing sides of the pump chamber to control fluid flow into and out of the pump chamber).

In <FIG>, for purposes of discussion herein, valves <NUM> are labeled in three valve groups V1, V2, and V3. Valve group V1 may be a diluent valve group having three valves P1, P2, and P3. Valve group V2 may be a reconstitution valve group having three valves P1, P2, and P3. Piston pump valves P1 and P2 of valve group V3 (e.g., a piston pump valve group) may be operated alternately in cooperation with piston pump <NUM>. For example, during a forward stroke of piston pump <NUM>, valve V3/P1 may be closed and valve V3/P2 may be open and during a backward stroke of piston pump <NUM>, valve V3/P1 may be open and valve V3/P2 may be closed to pump fluid in a first direction within the fluid pathways of cartridge <NUM>. In another example, to pump fluid in an opposite, second direction within the fluid pathways of cartridge <NUM>, during a forward stroke of piston pump <NUM>, valve V3/P1 may be open and valve V3/P2 may be closed and during a backward stroke of piston pump <NUM>, valve V3/P1 may be closed and valve V3/P2 may be open.

<FIG> show various examples of valve configurations for pumping fluids through cartridge <NUM> for various portions of a compounding operation using the valve labels shown in <FIG> for reference. In the example of <FIG>, the valves of valve groups V1 and V2 are configured for pumping diluent from a diluent container directly to a receiving container (e.g., valves P1 and P3 of group V1 are closed, valve P2 of group V1 is open, valves P1 and P2 of group V2 are closed, and valve P3 of group V2 is open to form a fluid path <NUM> from one of diluent ports <NUM> to receiving container port <NUM>).

In the example of <FIG>, the valves of valve groups V1 and V2 are configured for pumping diluent from a diluent container to a vial for reconstitution operations (e.g., valves P1 and P3 of group V1 are closed, valve P2 of group V1 is open, valves P2 and P3 of group V2 are closed, and valve P1 of group V2 is open to form a fluid path <NUM> from one of diluent ports <NUM> to vial port <NUM>). As shown, during reconstitution operations, a hazardous vapor path <NUM> may be formed from a vial waste port <NUM> to waste port <NUM> to be provided to waste container <NUM>. In some embodiments, a non-hazardous waste path <NUM> may be provided from a non-hazardous vial waste port <NUM> to air filter port <NUM>. However, this is merely illustrative. In some embodiments, air filter port <NUM> may be associated with air filter check valve structures <NUM>, <NUM>, and <NUM> that prevent flow of any vapor waste along path <NUM> and ensure that all vapor waste from vial <NUM> is moved along path <NUM> through waste port <NUM>.

In the example of <FIG>, the valves of valve groups V1 and V2 are configured for pumping a reconstituted drug from a vial to a receiving container for compounding operations (e.g., valves P1 and P2 of group V1 are closed, valve P3 of group V1 is open, valves P1 and P1 of group V2 are closed, and valve P3 of group V2 is open to form a fluid path <NUM> from vial port <NUM> to receiving container port <NUM>). As shown, during compounding operations, a path <NUM> may be formed from air filter port <NUM> to non-hazardous vapor vial port <NUM> to provide filtered, sterile air from outside cartridge <NUM> into the vial to prevent a vacuum from being generated when the drug is pumped from the vial.

Although the receiving container <NUM> is shown in, for example, <FIG>, <FIG>, and <FIG>, as an IV bag, in some scenarios, the receiving container <NUM> may be implemented as a syringe. For example, a Texium® connector coupled by tubing to an output port such as receiving container port <NUM> may be connected to a needle free valve connector such as a SmartSite® connector, the SmartSite® connector being coupled by additional tubing to another needle free valve connector (e.g., another SmartSite® connector) that is connected to a syringe for receiving a reconstituted drug. In scenarios in which the receiving container is a syringe, it may be desirable, after pumping the drug from the vial into the syringe, to remove air or other vapors from the syringe.

In the example of <FIG>, the valves of valve groups V1 and V2 are configured for pumping air from a receiving container such as a syringe (e.g., valves P1 and P3 of group V1 are closed, valve P2 of group V1 is open, valves P2 and P3 of group V2 are closed, and valve P1 of group V2 is open to form a fluid path <NUM> from receiving container port <NUM> to waste port <NUM>). In some configurations, the valves P1 and P2 of group V3 may be alternately opened and closed in cooperation with the motion of piston pump <NUM> to move the desired fluid or vapor along the fluid pathways defined by valves <NUM>.

<FIG> is a chart showing the position and operation of the valves <NUM> as labeled in <FIG> during various portions of a reconstitution/compounding process as described above in connection with <FIG>.

<FIG> is a cross-sectional side view of cartridge <NUM> with the cross section take through diluent ports 3100D, waste port 3100W, and receiving container port <NUM>. As shown in the example of <FIG>, each diluent port 3100D may be formed by a portion of membrane <NUM> that is formed within an opening in bezel <NUM> and adjacent to a diluent chamber 8200D. Waste port 3100W may be formed by a portion of membrane <NUM> that is formed within an opening in bezel <NUM> and adjacent to a vapor waste chamber 8200W. Receiving container port <NUM> may be formed from an opening that leads to a receiving container chamber <NUM> in which tubing that extends into backpack <NUM> may be disposed to form a fluid path to the receiving container from cartridge <NUM>.

When compressed by a sealing manifold membrane such as sealing manifold membrane <NUM> of manifold <NUM> of <FIG>, the portion of sealing membrane <NUM> that forms diluent and/or waste ports <NUM> creates a drip-free connection between the manifold <NUM> and the cartridge. A manifold needle <NUM> of a selected diluent manifold <NUM> and a manifold needle of a waste manifold can extend through the corresponding manifold membrane <NUM> and the sealing membrane <NUM> in the respective diluent and waste port to form fluid paths through sealing membrane <NUM> (e.g., through opening <NUM>, central bore <NUM>, and opening <NUM> of needle <NUM>) for diluents and waste vapors for reconstitution and compounding operations.

However, the example of <FIG>, in which the seal of ports 3100D and 3100W are formed solely by a portion of membrane <NUM> that extends into an opening in bezel <NUM> is merely illustrative. In some embodiments, in order to provide an improved drip-free seal, the seal of each of ports 3100D and port 3100W may be formed by a plurality of sealing members. In one example, three sealing members may be provided to form a port seal for cartridge <NUM>.

<FIG> shows a cross-sectional view of a port of cartridge <NUM> in an implementation with three sealing members. As shown in <FIG>, a port <NUM> (e.g., one of diluent port 3100D or waste port 3100W) may be formed from a portion of membrane <NUM> that is disposed between an outer sealing member <NUM> (formed in an opening <NUM> in bezel <NUM>) and an inner sealing member <NUM>. Inner sealing member <NUM> may be disposed between membrane <NUM> and chamber <NUM>.

As shown in <FIG>, outer sealing member <NUM> may include a portion that extends through opening <NUM> and may also include a recess <NUM> on an interior surface adjacent to membrane <NUM>. Membrane <NUM> may also include a recess <NUM> on an interior surface adjacent to inner sealing member <NUM>. Providing a port <NUM> with multiple sealing members such as the three sealing members (i.e., member <NUM>, member <NUM>, and the portion of membrane <NUM> formed between members <NUM> and <NUM>) may provide an enhanced wiping of needle <NUM> to provide an improved dry disconnect in comparison with implementations with a single sealing member. However, this is merely illustrative. In various embodiments, one, two, three, or more than three sealing members for each port may be provided. Similarly, interstitial spaces formed from recesses <NUM> and <NUM> may further increase the efficiency of the wiping of needle <NUM>, however, in various embodiments, sealing members may be provided with or without recesses <NUM> and/or <NUM>.

<FIG> shows the manifold <NUM> with manifold sealing member <NUM> compressed against outer sealing member <NUM> of port <NUM>. As shown in <FIG>, needle <NUM> is extended from manifold <NUM> through sealing members <NUM> and <NUM>, through interstitial space <NUM>, through membrane <NUM>, through interstitial space <NUM>, and through inner sealing member <NUM> such that openings <NUM> and <NUM> and central bore <NUM> form a fluid pathway between cartridge <NUM> and manifold <NUM>.

In the example of <FIG>, the portion of membrane <NUM> that extends into the openings in bezel <NUM> in ports <NUM> may be compressed (e.g., compressed by <NUM>% radially) to cause a wiping effect on the diluent needles that are extended therethrough and withdrawn therefrom so that when the diluent needles are retracted into the manifold, no liquid is left on the diluent needle or one the outer surfaces of the cartridge or the membrane.

In the example of <FIG> and <FIG>, the portion of sealing member <NUM> that extends into the openings in bezel <NUM> in ports <NUM> may be compressed (e.g., compressed by <NUM>% radially) to cause a wiping effect on the diluent needles that are extended therethrough and withdrawn therefrom so that when the diluent needles are retracted into the manifold, no liquid is left on the diluent needle or one the outer surfaces of the cartridge or the membrane. The multiple sealing members of <FIG> and <FIG> may be arranged to each provide a wiping effect on needle <NUM> that complements the wiping effect of the other sealing members (e.g., by providing, with each member, a peak wiping force on the needle at locations angularly spaced with respect to the peak wiping force of other members).

<FIG> is cross-sectional perspective side view of cartridge and backpack assembly <NUM> in which protrusion <NUM> and protrusion <NUM> of cartridge frame <NUM> can be seen cooperating to couple cartridge <NUM> to backpack <NUM> to form cartridge and backpack assembly <NUM>. To install backpack <NUM> onto cartridge <NUM>, opening <NUM> of backpack <NUM> can be positioned over protrusion <NUM> and backpack <NUM> can be rotated (e.g., in a direction <NUM>) to push latching features <NUM> of backpack <NUM> against latching protrusion <NUM> until latching protrusion <NUM> snaps into position between latching features <NUM>. As shown, protrusion <NUM> may be formed on an additional latching structure of cartridge <NUM> such as a flexible arm <NUM>. Flexible arm <NUM> may allow backpack <NUM> to be pulled downward by a small distance when backpack <NUM> is rotated to press latching feature <NUM> onto protrusion <NUM>. Flexible arm <NUM> may be resilient to maintain an upward force the holds latching features <NUM> in a latched position against protrusion <NUM>.

In the example of <FIG>, a vial <NUM> and vial puck <NUM> are positioned adjacent to cartridge and backpack assembly <NUM> with needle assembly <NUM> extended into the vial through sealing member <NUM> of cartridge <NUM> and sealing member <NUM> of vial puck <NUM> which may provide a drip free seal and allow fluid to be provided into and/or removed from vial <NUM>. Sealing member <NUM> may be, for example, an implementation of sealing member <NUM>. As shown, when the needle assembly <NUM> is extended into the vial, portions of the vial puck <NUM> may be located adjacent to latching features <NUM> of backpack <NUM>.

<FIG> shows a cross-sectional view of a portion of cartridge <NUM> along with an enlarged view of a portion of needle assembly <NUM>. As shown in <FIG>, needle housing <NUM> may include a sealing membrane <NUM> formed within an annular housing member <NUM> that is attached to cartridge frame <NUM> via one or more housing arms <NUM>. A spring <NUM> may be provided that extends from needle housing 317B into needle housing <NUM> such that compression of spring <NUM> is necessary to extend needles <NUM> and <NUM> through sealing membrane <NUM>. In this way, a user handling cartridge <NUM> is prevented from being injured by access to needle assembly <NUM>. In operation, a vial puck may be pressed against annular housing member <NUM> to compress spring <NUM> such that needle assembly <NUM> extends through sealing membrane <NUM> and through a sealing membrane of the vial puck into the vial.

Dual lumen needles <NUM> and <NUM> may be respectively provided with openings <NUM> and <NUM> that provide fluid access to central bores of the needles. Needle <NUM> may, for example, be a <NUM> gauge needle held in cartridge frame <NUM> by a high density polyethylene (HDPE) overmold 317A, the needle having an opening <NUM> for venting the drug vial. Opening <NUM> may be formed using a slot cut as shown to reduce coring of the sealing membranes as the needle is inserted and retracted. Needle <NUM> may, for example, be an <NUM> gauge needle held in cartridge frame by a high density polyethylene (HDPE) overmold 317B with one or more openings <NUM> for fluid flow into and/or out of the vial. Openings <NUM> may include two drilled holes configured to reduce coring and to allow up to, for example, <NUM>/min of fluid flow.

In this way, during reconstitution operations, diluent may be provided into the vial via openings <NUM> of needle <NUM> and vapor waste may be simultaneously extracted from the vial via opening <NUM> in needle <NUM>. During compounding operations, a reconstituted drug may be pulled from the vial via openings <NUM> of needle <NUM> and sterile air may be provided into the vial via opening <NUM> of needle <NUM>.

Various aspects of a dry disconnect are described (e.g., a dry disconnect between cartridge <NUM> and vial <NUM> via vial puck <NUM>). For example, a dry disconnect can be achieved when the needle of cartridge <NUM> is wiped or "squeegeed" clean as it retracts through sealing membranes of puck <NUM> and cartridge <NUM>. However, compounder <NUM> is a closed system transfer device (CSTD) that requires certain processes to happen out of "first air. " One of the processes that is performed out of first air is inserting cartridge needle into vial <NUM>. This requires protecting the vial needle from "outside" air while also allowing a leak free disconnect when the vial is removed from the cartridge needle. Accordingly, in various implementations, additional features may be provided to help ensure a dry disconnect.

For example, <FIG> show an exemplary implementation of a vial puck <NUM> (e.g., an implementation of vial puck <NUM>) that includes a hydroscopic member <NUM> in addition to a sealing membrane <NUM> (e.g., an implementation of sealing membrane <NUM>).

In the example of <FIG>, a single lumen needle <NUM> is shown, however this is merely illustrative and a puck having a hydroscopic medium and a sealing membrane may be adapted to any needle configuration. In the example of <FIG>, vial septum <NUM> of vial cap <NUM> works in conjunction with vial puck membrane <NUM> to "squeegee" any fluid from the outside of the needle. Additionally, as shown in the cross-sectional view of <FIG>, located between vial puck membrane <NUM> and vial septum <NUM> is a hydroscopic material <NUM> (e.g., a sponge) that is "feature flexible," allowing hydroscopic material <NUM> to absorb fluid in hard to reach areas of needle <NUM> such as corners and fluid passage openings.

For example, <FIG> shows a cross-sectional view of a configuration in which opening <NUM> of needle <NUM> is disposed within hydroscopic material <NUM> during retraction of the needle from vial cap <NUM> while sealing membrane <NUM> wipes a portion of the needle at interface <NUM> and vial septum <NUM> wipes another portion of needle <NUM> at interface <NUM>. Absorbing fluid in hard to reach areas as shown in <FIG> allows a greater chance of a good dry disconnect as the vial needle is retracted.

<FIG> shows a partially transparent view of puck <NUM> and vial cap <NUM> in which the exterior side of puck <NUM> and a portion of vial puck membrane <NUM> are visible (within the housing of puck <NUM> shown in partial transparency to allow viewing of hydroscopic material <NUM>) with a needle having a bevel cut <NUM> passing through vial puck membrane <NUM>, hydroscopic material <NUM> and vial septum <NUM>.

<FIG> shows a perspective cross-sectional view of the needle passing through a hydroscopic medium adjacent to a vial septum, in which the hydroscopic medium is provided with a plurality of radial slits <NUM>. <FIG> shows an exemplary implementation in which a stack <NUM> of hydroscopic media with slits can be provided spaced apart from the puck sealing membrane.

Having hydroscopic material <NUM> sandwiched between vial puck membrane <NUM> and vial septum <NUM> allows a successful dry disconnect to be made with various vial needle configurations and sizes. For example, coaxial needles <NUM> and <NUM> described herein (see, e.g., <FIG>) can include an abrupt step between the main needle and the air bleed needle, making it difficult to clear that area of fluid. However, feature conforming hydroscopic material <NUM> allows the needle interface step area to be cleared of fluid prior to needle extraction.

In addition to providing hydroscopic material <NUM> in puck <NUM>, in some implementations, prior to pulling needle <NUM> completely from vial septum <NUM>, a slight vacuum may be constantly pulled on the fluid needle <NUM> (as indicated by arrow <NUM> of <FIG>) to clear the needle's internal fluid passages (which may also clear the vent needle passage of fluid in a dual lumen needle configuration). Clearing the needle fluid passage may reduce or eliminate the possibility of any fluid wicking onto the outside of any of the dry disconnect surfaces once the needle starts to separate from the vial puck dry disconnect. In addition, pulling a constant vacuum as the port of the needle is being pulled through the various membranes, helps remove any fluid remaining between needle <NUM> and the membrane passages.

For example, as shown in <FIG>, fluid <NUM> that may be disposed between needle <NUM> and puck sealing membrane <NUM> may be pulled into needle <NUM> by a vacuum as the side port <NUM> of needle <NUM> travels through membrane <NUM>, so that the surface <NUM> of needle <NUM> is dry. In implementations in which a vacuum is applied to during retraction of needle <NUM>, needle <NUM> may be provided with openings configured to facilitate the vacuum features (e.g., needle <NUM> may be provided without two holes of the same size located vertically from each other on the needle to prevent, during the vacuum process, only the top opening being cleared of fluid with the bottom opening not being cleared of fluid and causing a dry disconnect failure).

In addition to, or instead of providing vial puck <NUM>/<NUM> with a hydroscopic medium and/or an internal vacuum pressure, to help ensure a dry disconnect, cartridge <NUM> may be provided a bellows that surrounds needle <NUM> (or needles <NUM>/<NUM>). <FIG> show various views of a needle assembly that includes a bellows. <FIG> shows a perspective view of an exemplary implementation of cartridge <NUM> having a needle assembly <NUM> with bellows <NUM> that surrounds the needle (and having dial valves instead of membrane valves). <FIG> shows bellows <NUM> in partial transparency so that the position of needle <NUM> within bellows <NUM> can be seen. Needle <NUM> in the examples of <FIG> may be implemented as a dual lumen needle formed from metal or plastic.

<FIG> shows bellows <NUM> again in partial transparency and shows how an internal extension spring <NUM> within bellows <NUM> and around needle <NUM> may be provided to bias bellows <NUM> in an extended configuration in which needle <NUM> is completely surrounded by (and sealed within) bellows <NUM> (e.g., in the absence of an external force that overcomes the tension of spring <NUM>). As shown in <FIG>, bellows <NUM> may be bonded to a lower surface <NUM> (e.g., a lower surface of cartridge frame <NUM>) to form an airtight seal with lower surface <NUM>.

Bellows <NUM> may be formed from silicone or other flexible materials. Bellows <NUM> may also include a dry disconnect mating area <NUM> configured to mate with a vial or vial puck dry disconnect feature. As shown in <FIG>, dry disconnect mating area <NUM> may include a seal <NUM> configured to be pierced by needle <NUM> when vial lift <NUM> lifts a vial/vial puck assembly toward cartridge <NUM> (e.g., in direction <NUM>) to compress bellows <NUM> while needle <NUM> remains fixed. In the configuration shown in <FIG>, seal <NUM> maintains a sealed cavity within bellows <NUM>.

As a vial/vial puck assembly is pulled towards cartridge <NUM>, bellows <NUM> compresses until eventually needle <NUM> protrudes through all of the dry disconnects. Later, as the vial/vial puck assembly is retracted (e.g., in direction <NUM> of <FIG>) and needle <NUM> is extracted, bellows <NUM> begins to expand and create a slight vacuum within cavity <NUM> of bellows <NUM>. This vacuum helps pull in any remaining fluid between needle <NUM> and the dry disconnect membranes. Removing any excess fluid, helps promote a better dry disconnect between the two membrane surfaces.

As previously noted, in some implementations, needle <NUM> may be a dual-lumen plastic needle. <FIG> show various views of an exemplary implementation of a dual-lumen plastic needle for cartridge <NUM>. As shown in the partial transparency side view of <FIG>, needle <NUM> may be provided with an upper fluid port <NUM>, a lower fluid port <NUM>, an upper vent port <NUM>, and a lower vent port <NUM>. <FIG> shows a cross-sectional view of needle <NUM> in which divider <NUM> can be seen separating the fluid side (fluid pathway) from the vent side (vent pathway) of the needle. As shown in <FIG>, one or more internal features such as a ledge <NUM> may be provided as guide to aid in installation of divider <NUM>. As shown in <FIG>, needle <NUM> may be provided with energy directors <NUM> on the upper fluid and vent ports for ultrasonic welding of the ports to corresponding fluid and vent paths within cartridge <NUM>. As shown in <FIG>, needle <NUM> may be provided with a smooth needle tip <NUM> to prevent coring of sealing membranes. <FIG> shows a top-side perspective view of needle <NUM> with divider <NUM>. Divider <NUM> may be solvent bonded to the main body of the needle or may be integrally formed with the main body. As shown in <FIG>, additional channel definition members such as channel definition member <NUM> may be provided to shape and size the fluid lumen and the vent lumen of the dual-lumen needle. Channel definition members such as channel definition member <NUM> may be integrally formed with the main body of the needle or may be separate members.

In the example of <FIG>, cartridge <NUM> interacts with a vial <NUM> containing a drug using a dual lumen vial/vent plastic needle <NUM>. Needle <NUM> has a fluid passage large enough to handle a wide range of fluid viscosities and also a passage to allow the vial to be vented to prevent pressure or vacuum buildup in the vial. In addition, needle <NUM> includes features that prevent coring of the vial and dry disconnect membranes. For example, instead of fluid passages that exit towards the tip of the needle, needle <NUM> in the examples of <FIG> includes fluid port <NUM> and vent port <NUM> located on the sides of the needle rather than the tip of the needle, reducing the sharp edges that can sometimes cause coring.

In various implementations, needle <NUM> may be a two piece plastic needle that is composed of the main body and a divider (e.g., divider <NUM>) that separates the fluid passage from the air vent passage. The two pieces are either welded or solvent bonded together to form a permanent assembly. The fluid and air ports <NUM> and <NUM> exit the side of the needle rather thru the tip of the needle. This helps to prevent coring of the vial and dry disconnect membranes. The ports <NUM> and <NUM> may also be located <NUM> degrees to each other for moldability (see, e.g., <FIG>).

Although various implementations have been described in which a needle for coupling cartridge <NUM> to vial <NUM> through vial puck <NUM> is disposed in the cartridge, it should be appreciated that, in other implementations, the needle or a cannula may be disposed in vial puck <NUM> for coupling vial <NUM> to cartridge <NUM>. <FIG> show various views of an exemplary implementation in which a dual-lumen cannula is disposed in puck <NUM>. For example, <FIG> respectively show side and perspective views of vial puck <NUM> with an incorporated cannula (not visible in <FIG>; see <FIG>) and two dry disconnect valves <NUM> and <NUM> used to make the mate between vial <NUM> and cartridge <NUM>. Since the material of the vial stopper is typically chosen by the pharmaceutical companies and may be variable from vial to vial, providing the cannula as part of vial puck <NUM> may reduce the risks of coring the vial stopper, as the vial is only accessed by this cannula a single time.

Additionally, in the initial state shown in <FIG>, the cannula is in a retracted position that allows the puck to be attached to the vial without piercing the stopper. When the cartridge is first mated to vial puck <NUM>, a protrusion <NUM> on cartridge <NUM> advances the cannula into vial <NUM>.

This configuration may increase the usable life of the drug from beginning when the puck is attached, to when it is first mated to a cartridge, allowing the pucks to be installed many hours or even days prior to when the drug is needed. The puck also incorporates two dry disconnect valves <NUM> and <NUM> that allow for a needless fluid transfer to and from vial <NUM>. The connection is achieved by a ridged plastic face coming together with a compliant plastic face. As shown, the compliant face is attached to a bellows and as it compresses, a port on the ridged component is exposed and allows for fluid transfer. Since fluid is not transferred across the two faces, when the connection is terminated, the faces will remain dry. By placing two of these connections on the cap, fluid and waste air are able to be independently transferred from the vial.

When adding/removing fluid from vial <NUM>, it is desirable for an equal amount of air to be evacuated/introduced to the vial to equalize the pressure in the vial. In the example of <FIG>, when fluid is added to vial <NUM> from cartridge <NUM>, this air is displaced through the aforementioned dry disconnect valve. When fluid is removed from vial <NUM>, ambient air is introduced to vial <NUM> though a check valve/filter combination.

Having the cannula incorporated into the vial puck significantly reduces the risks of the vial stopper coring, thus reducing the possibility of fragments entering the cartridge and ultimately, entering the patient. The ability to install the puck and have the needle/plastic cannula pierce the vial at a later time, also increases the amount of time the drug/puck combination can be used for after the cap is installed. The inclusion of the dry disconnect valves, as in the example of <FIG>, may also eliminate the use of a needle in cartridge <NUM> and allow for a wider range of flow rates while maintaining a leak-free seal at disconnection.

<FIG> shows a side view of an exemplary implementation of a dual-lumen plastic cannula <NUM> that may be provided within puck <NUM> to be actuated by protrusion <NUM>. <FIG> shows a cross-sectional view of cannula <NUM> in which a fluid path <NUM> and an air/vent path <NUM> are visible. <FIG> shows a partially transparent side view of puck <NUM> attached to vial <NUM> in which cannula <NUM> is completely disposed within puck <NUM> and vial <NUM> has not yet been accessed. <FIG> shows a partially transparent side view of puck <NUM> attached to vial <NUM> in which cannula <NUM> has been extended into vial <NUM> by protrusion <NUM> on puck <NUM>. <FIG> shows a bottom side perspective view of puck <NUM> in which cannula <NUM> is completely disposed within opening <NUM> of puck <NUM>. <FIG> shows a bottom side perspective view of puck in which cannula <NUM> has been extended into recess <NUM> of puck <NUM>, recess <NUM> being configured to attach to the top of a vial <NUM>.

The retracted state of <FIG> allows puck <NUM> to be attached without puncturing the vial. This advances the usable life of the drug from beginning when the puck is attached, to when it is first mated to a cartridge, allowing the pucks to be installed many hours or even days prior to when the drug in the vial is needed. Since the material of the vial stopper is chosen by the pharmaceutical companies and can be difficult to control, providing puck <NUM> with a needle or cannula <NUM> incorporated into vial puck <NUM>, can help reduce the risks of coring the vial stopper as the vial is only accessed by the needle/cannula a single time.

<FIG> shows cartridge <NUM> and vial puck <NUM> aligned for coupling. As shown in <FIG>, bellows <NUM> of each of the dry disconnect valves compresses on insertion and seals against the face of puck <NUM> to allow a conduit <NUM> of each of the dry disconnect valves to be exposed to create the desired fluid and/or vent pathways between vial <NUM> and cartridge <NUM> (e.g., via pathways <NUM> and <NUM> of the cannula). <FIG> shows a side view of a portion of cartridge <NUM> in which bellows <NUM> protect and surround the conduits of each dry disconnect valve. As shown in the side views of puck <NUM> in <FIG>, in the example of <FIG>, puck <NUM> may be provided with an ambient air filter <NUM> that filters incoming ambient air and a check valve <NUM> that ensures that waste air cannot escape the system.

As described above in connection with, for example, <FIG>, cartridge <NUM> may be provided with one or more diluent ports 3100D and/or one or more waste ports. One or more manifolds, each having a needle may be coupled to a respective diluent container or waste container. The needle of each manifold may be extended by the pump head into a corresponding port <NUM> to couple the diluent or waste container to cartridge <NUM>. However, in some implementations, ports <NUM> and the associated magazines can be implemented with a dry disconnecting interface that does not include a needle. <FIG> show an exemplary implementation of a dry disconnecting interface using a face seal and a side ported shuttle valve that can be used to couple, for example, containers <NUM> or <NUM> to cartridge <NUM>.

The dry disconnecting interface of <FIG> allows for a dry disconnection between the compounder manifold and cartridge diluent ports. A face seal keeps fluid from leaking into the environment while a shuttling valve is used to enable and disable flow. Having a face seal and a shuttling valve eliminates the use of a needle and allows for a wider range of flow rates while maintaining a leak-free seal at disconnection. <FIG> shows a male portion <NUM> and a female portion <NUM> of a dry disconnect shuttle valve. For example, male portion <NUM> may be connected to a diluent container via tubing and female portion <NUM> may be an implementation of one of diluent ports 3100D of cartridge <NUM>.

<FIG> shows male side <NUM> and female side <NUM> in cross section, spaced apart by a gap <NUM> and disconnected. <FIG> shows male side <NUM> and female side <NUM> in cross section, in contact at interface <NUM>, with the fluid path between male side <NUM> and female side <NUM> still closed. <FIG> shows male side <NUM> and female side <NUM> in cross section, connected with shuttle valve <NUM> of male side <NUM> extended into female side <NUM> such that a side port <NUM> provides a fluid path <NUM> from male side <NUM> to female side <NUM>. <FIG> shows a broader view of male side <NUM> and female side <NUM> in cross section with the fluid path closed.

In some implementations of compounder <NUM>, one or more filters may be provided in the fluid flow path between cartridge <NUM> and receiving container <NUM> (e.g., to prevent any coring material of the vial septum or any foreign matter left within the cartridge from flowing into the receiving container). A compounded drug is transferred between cartridge <NUM> and receiving container <NUM> via tubing such as "pigtail" tubing in some embodiments. For example, a filter and/or screen may be provided within the cartridge or an in-line fluid filter located at the end of the pigtail prior to the receiving container may be provided. <FIG> and <FIG> show exemplary implementations of a connector (e.g., a Texium® connector) for coupling to receiving container input <NUM> in which a filter <NUM> is provided at the interface between the connector and tubing for coupled to cartridge <NUM>. In the example of <FIG>, the connector is shown in partial transparency so that filter <NUM> within the connector is visible. In the example of <FIG>, a separate filter/screen element <NUM> is disposed between the connector and the tubing.

Although various implementations of cartridge <NUM> have been described in which an oscillating piston pump (see, e.g., piston <NUM> of <FIG>) is operated to move fluid and/or gasses through cartridge <NUM> and from diluent containers and to a receiving container, in other implementations, a syringe pump may be used instead of or in addition to an oscillating piston pump. <FIG> shows an exemplary implementation of a syringe piston <NUM> and an associated grasping mechanism <NUM> (e.g., for grasping and actuating the syringe piston). In the example of <FIG>, syringe piston <NUM> includes a tapered grab handle <NUM> and one or more seals such as o-rings <NUM>. O-rings <NUM> may be provided to seal the plunger to the bore of the syringe pump (not shown) instead of, for example, a rubber "boot" that fits over the end of the plunger tip (e.g., which can, in some circumstances allow for volumetric inaccuracies if the rubber boot flexes fore and aft as the plunger changes directions as it is being pulled or pushed). O-rings <NUM> can therefore be particularly helpful in micro-dosing scenarios.

Grasping mechanism <NUM> may be a claw with arms that can be actuated to grasp grasping handle <NUM>. Grasping mechanism <NUM> may be actuatable to slowly move syringe piston <NUM> to pump fluid and/or gas. In order to help ensure the volumetric accuracy of fluids and/or gasses pumped by slowly actuating syringe piston <NUM>, as shown in <FIG>, grasping mechanism <NUM> may include tapered surfaces <NUM> that are complementary to the tapered shape of grasping handle <NUM>. Providing a tapered claw <NUM> may reduce or eliminate backlash when mating grasping mechanism <NUM> and tapered grasping handle <NUM> of syringe plunger <NUM> (e.g., by reducing or eliminating clearances between mating parts). For example, the tapered end <NUM> of syringe plunger <NUM> may be slid into the tapered groove of a syringe activation device such as claw <NUM>. Syringe plunger <NUM> may be securely held by approximately <NUM> degrees of contact by the syringe activation device.

The claw portion of grasping mechanism <NUM> may be spring loaded or mechanically actuated. In other implementations, grasping mechanism <NUM> may be a claw having a pitchfork design without moving parts.

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.

Claim 1:
A compounder system (<NUM>), comprising:
a cartridge (<NUM>) having:
a plurality of controllable fluid pathways fluidly coupled to at least one diluent port (<NUM>) and a receiving container port (<NUM>),
a pump configured to pump a fluid within the plurality of controllable fluid pathways, and
a needle (<NUM>) configured to couple the plurality of controllable fluid pathways to a vial containing a drug; and
a vial puck (<NUM>) configured to attach to the vial, wherein the vial puck (<NUM>) comprises:
a sealing membrane (<NUM>) and
a hydroscopic member (<NUM>) configured to absorb a portion of the fluid from the needle (<NUM>), wherein the hydroscopic member (<NUM>) is disposed between the sealing membrane (<NUM>) of the vial puck (<NUM>) and a vial septum (<NUM>) of the vial when the vial puck (<NUM>) is attached to the vial,
characterized by the pump further being configured to generate a vacuum pressure in the needle (<NUM>) when the needle (<NUM>) is extracted from the vial and the vial puck (<NUM>).