Patent Publication Number: US-2022226194-A1

Title: Dry disconnect cartridge and dual lumen needle for automatic drug compounder

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 16/497,176 entitled “DRY DISCONNECT CARTRIDGE AND DUAL LUMEN NEEDLE FOR AUTOMATIC DRUG COMPOUNDER,” filed Sep. 24, 2019, which is the national stage entry and claims priority to International Patent Application No. PCT/US2018/024086 entitled “DRY DISCONNECT CARTRIDGE AND DUAL LUMEN NEEDLE FOR AUTOMATIC DRUG COMPOUNDER,” filed on Mar. 23, 2018, which claims priority to U.S. Provisional Patent Application Ser. No. 62/476,692 entitled “AUTOMATIC DRUG COMPOUNDER,” filed on Mar. 24, 2017, the disclosures of which are hereby incorporated by reference in their entirety for all purposes. 
    
    
     TECHNICAL FIELD 
     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. 
     BACKGROUND 
     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. 
     SUMMARY 
     One or more embodiments provide a compounder system which include a cassette cartridge having a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port. The cassette cartridge further including a pump member actuable 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, wherein the needle comprises a dual-lumen needle. 
     One or more embodiments provide a method including coupling a cartridge to a pump head of a compounder system, the cartridge having a body enclosing a plurality of fluid pathways, a dual-lumen needle extending from the body and having a first lumen fluidly coupled to at least one of the fluid pathways and a second lumen fluidly coupled to a gas pathway, and a bellows forming a cavity within which the dual-lumen needle is disposed. The method further including extending the dual-lumen needle into a vial by compressing the bellows with the vial, comprising moving the vial toward the cartridge such that a tip of the dual-lumen needle extends into the vial. 
     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 the 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 a dry disconnect, the cartridge includes a bellows that surrounds needle. The bellows is compressible to expose the needle for insertion into the vial and generates a vacuum condition within the bellows when the bellows is extended from a compressed configuration to an extended configuration. The needle may be a dual-lumen plastic needle. 
     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, a pump component actuable 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 cartridge also includes a bellows configured to surround the needle in an extended configuration and to be compressed to allow the needle to extend from the bellows into the vial. 
     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 pump member actuable 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, wherein the needle comprises a dual-lumen plastic needle. 
     In accordance with other aspects of the disclosure, a method is provided that includes coupling a cartridge to a pump head of a compounder system, the cartridge having a body enclosing a plurality of fluid pathways, a needle extending from the body and having a lumen fluidly coupled to at least one of the fluid pathways, and a bellows forming a cavity within which the needle is disposed; and extending the needle into a vial by compressing the bellows with the vial. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are included to provide further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and together with the description serve to explain the principles of the disclosed embodiments. In the drawings: 
         FIG. 1  illustrates a front perspective view of an example of an exemplary embodiment of a compounding system in accordance with aspects of the present disclosure. 
         FIG. 2  illustrates a front perspective view of the compounding system of  FIG. 1  with a transparent housing in accordance with aspects of the present disclosure. 
         FIG. 3  illustrates a side view of the compounding system of  FIG. 1  with the housing removed in accordance with aspects of the present disclosure. 
         FIG. 4  illustrates a perspective view of an exemplary embodiment of a pump drive mechanism in accordance with aspects of the present disclosure. 
         FIG. 5  illustrates an exploded view of the pump drive mechanism of  FIG. 4  in accordance with aspects of the present disclosure. 
         FIG. 6  illustrates a perspective view of a pump head assembly with an exemplary embodiment of a gripping system and vial puck in accordance with aspects of the present disclosure. 
         FIG. 7  illustrates a perspective view of the pump head assembly, gripping system and vial puck of  FIG. 6  in accordance with aspects of the present disclosure. 
         FIG. 8  is a flow chart illustrating an exemplary embodiment of the steps of a process in accordance with aspects of the present disclosure. 
         FIG. 9  illustrates a perspective view of an exemplary embodiment of a cartridge in accordance with aspects of the present disclosure. 
         FIG. 10  illustrates a perspective view of an exemplary embodiment of a carousel with a cover in accordance with aspects of the present disclosure. 
         FIG. 11  illustrates a front perspective view of another exemplary embodiment of a compounding system in accordance with aspects of the present disclosure. 
         FIG. 12  illustrates a front perspective view of the compounding system of  FIG. 11  with portions of the housing removed in accordance with aspects of the present disclosure. 
         FIG. 13  illustrates a rear perspective view of the compounding system of  FIG. 11  with portions of the housing removed in accordance with aspects of the present disclosure. 
         FIG. 14  illustrates a perspective view of the compounding system of  FIG. 11  with various components shown in enlarged views for clarity in accordance with aspects of the present disclosure. 
         FIG. 15  illustrates a perspective view of the cartridge of  FIG. 9  in accordance with aspects of the present disclosure. 
         FIG. 16  illustrates a perspective view of the cartridge of  FIG. 9  with a transparent bezel in accordance with aspects of the present disclosure. 
         FIG. 17  illustrates a perspective view of an exemplary embodiment of a cartridge with a backpack attachment in accordance with aspects of the present disclosure. 
         FIG. 18  illustrates a perspective view of the cartridge of  FIG. 17  with a transparent backpack attachment in accordance with aspects of the present disclosure. 
         FIG. 19  illustrates an exploded perspective view of another embodiment of a pump cartridge in accordance with aspects of the present disclosure. 
         FIG. 20A  illustrates a rear plan view of the cartridge of  FIG. 19  in accordance with aspects of the present disclosure. 
         FIG. 20B  illustrates a front plan view of the cartridge of  FIG. 19  in accordance with aspects of the present disclosure. 
         FIG. 21  illustrates a cross-sectional perspective view of the cartridge of  FIG. 19  with an attached backpack in accordance with aspects of the present disclosure. 
         FIG. 22  illustrates a cross-sectional side view of the cartridge of  FIG. 19  in accordance with aspects of the present disclosure. 
         FIG. 23  illustrates the cartridge of  FIG. 19  showing the valves and fluid flow paths in accordance with aspects of the present disclosure. 
         FIG. 24  illustrates the cartridge of  FIG. 19  showing a valve configuration for a diluent to receiving container fluid path in accordance with aspects of the present disclosure. 
         FIG. 25  illustrates the cartridge of  FIG. 19  showing a valve configuration for a reconstitution fluid path through in accordance with aspects of the present disclosure. 
         FIG. 26  illustrates the cartridge of  FIG. 19  showing a valve configuration for a compounding fluid path from in accordance with aspects of the present disclosure. 
         FIG. 27  illustrates the cartridge of  FIG. 19  showing a valve configuration for an air removal fluid path in accordance with aspects of the present disclosure. 
         FIG. 28  is a chart showing the positioning of certain valves in accordance with aspects of the present disclosure. 
         FIG. 29A  illustrates a cross-sectional side view of the cartridge of  FIG. 19  showing a plurality of ports in accordance with aspects of the present disclosure. 
         FIG. 29B  illustrates a cross-sectional side view of a portion of a diluent manifold having a needle that may interface with one of the ports of  FIG. 29A  in accordance with aspects of the present disclosure. 
         FIG. 29C  illustrates a cross-sectional side view of a portion of the cartridge of  FIG. 19  showing port seals formed by a plurality of sealing members in accordance with aspects of the present disclosure. 
         FIG. 29D  illustrates a cross-sectional side view of the portion of the manifold of  FIG. 29B  compressed against the portion of the cartridge of  FIG. 29C  in accordance with aspects of the present disclosure. 
         FIG. 30  illustrates a cross-sectional perspective view of the cartridge disposed adjacent a vial in accordance with aspects of the present disclosure. 
         FIG. 31  illustrates a cross-sectional side view of a portion of the cartridge of  FIG. 19  in the vicinity of a dual lumen needle in accordance with aspects of the present disclosure. 
         FIG. 32  illustrates a cross-sectional side view of a vial puck having a hydroscopic member in accordance with aspects of the present disclosure. 
         FIG. 33  illustrates another cross-sectional side view of a vial puck having a hydroscopic member in accordance with aspects of the present disclosure. 
         FIG. 34  illustrates a partially transparent side view of a vial puck having a hydroscopic member in accordance with aspects of the present disclosure. 
         FIGS. 35A and 35B  illustrate cross-sectional perspective views of a vial puck having a hydroscopic member in accordance with aspects of the present disclosure. 
         FIG. 36  illustrates another cross-sectional side view of a vial puck having a hydroscopic member in accordance with aspects of the present disclosure. 
         FIG. 37  illustrates another cross-sectional side view of a vial puck having a hydroscopic member in accordance with aspects of the present disclosure. 
         FIG. 38  illustrates a perspective view of a cartridge having a bellows in accordance with aspects of the present disclosure. 
         FIG. 39  illustrates a partially transparent side view of a portion of a cartridge having a bellows in accordance with aspects of the present disclosure. 
         FIG. 40  illustrates a partially transparent perspective view of a portion of a cartridge having a bellows in accordance with aspects of the present disclosure. 
         FIG. 41  illustrates a perspective view of a portion of a cartridge having a bellows in accordance with aspects of the present disclosure. 
         FIG. 42  illustrates a cross-sectional side view of a portion of a cartridge having a bellows in accordance with aspects of the present disclosure. 
         FIG. 43  illustrates another cross-sectional side view of a portion of a cartridge having a bellows in accordance with aspects of the present disclosure. 
         FIG. 44  illustrates a partially transparent side view of a portion of dual-lumen needle having a vertically separated fluid pathway and vent pathway in accordance with aspects of the present disclosure. 
         FIG. 45  illustrates a cross-sectional side view of the needle of  FIG. 44  in accordance with aspects of the present disclosure. 
         FIG. 46  illustrates a cross-sectional perspective view of the needle of  FIG. 44  in accordance with aspects of the present disclosure. 
         FIG. 47  illustrates a perspective view of the needle of  FIG. 44  in accordance with aspects of the present disclosure. 
         FIG. 48  illustrates another perspective view of the needle of  FIG. 44  in accordance with aspects of the present disclosure. 
         FIG. 49  illustrates another perspective view of the needle of  FIG. 44  in accordance with aspects of the present disclosure. 
         FIG. 50  illustrates a top view of the needle of  FIG. 44  in accordance with aspects of the present disclosure. 
         FIG. 51  illustrates a side view of portion of a compounder system including a vial puck having a cannula in accordance with aspects of the present disclosure. 
         FIG. 52  illustrates a perspective view of the portion of the compounder system of  FIG. 51  in accordance with aspects of the present disclosure. 
         FIGS. 53 and 54  illustrate side and cross-sectional side views of a cannula of a vial puck in accordance with aspects of the present disclosure. 
         FIG. 55  illustrates a partially transparent view of a vial puck, attached to a vial, and having a cannula in accordance with aspects of the present disclosure. 
         FIG. 56  illustrates a partially transparent view of the vial puck of  FIG. 55  with the cannula extended in accordance with aspects of the present disclosure. 
         FIG. 57  illustrates a perspective view of the vial puck of  FIG. 55  in accordance with aspects of the present disclosure. 
         FIG. 58  illustrates a perspective view of the vial puck of  FIG. 56  in accordance with aspects of the present disclosure. 
         FIG. 59  illustrates a partially transparent side view of portion of a compounder system including a vial puck having a cannula in accordance with aspects of the present disclosure. 
         FIG. 60  illustrates a partially transparent side view of portion of a compounder system including a cartridge coupled to a vial puck having a cannula in accordance with aspects of the present disclosure. 
         FIG. 61  illustrates a side view of portion of a compounder system including a cartridge having a protrusion, a needleless fluid port, and a needleless vent port in accordance with aspects of the present disclosure. 
         FIG. 62  illustrates a side view of portion of a compounder system including a vial puck having a cannula and a vent in accordance with aspects of the present disclosure. 
         FIG. 63  illustrates a side view of portion of a compounder system including a vial puck having a cannula and a check valve in accordance with aspects of the present disclosure. 
         FIG. 64  illustrates a perspective view of a dry disconnect shuttle valve in accordance with aspects of the present disclosure. 
         FIG. 65  illustrates a cross-sectional view of the dry disconnect shuttle valve of  FIG. 64  in accordance with aspects of the present disclosure. 
         FIG. 66  illustrates another cross-sectional view of the dry disconnect shuttle valve of  FIG. 64  in accordance with aspects of the present disclosure. 
         FIG. 67  illustrates a cross-sectional view of the dry disconnect shuttle valve of  FIG. 64  in a fluidly coupled configuration in accordance with aspects of the present disclosure. 
         FIG. 68  illustrates another cross-sectional view of the dry disconnect shuttle valve of  FIG. 64  in accordance with aspects of the present disclosure. 
         FIG. 69  illustrates a partially transparent perspective view of a connector having an inline filter in accordance with aspects of the present disclosure. 
         FIG. 70  illustrates a perspective view of a connector having an inline filter in accordance with aspects of the present disclosure. 
         FIG. 71  illustrates a perspective view of a portion of a syringe pump in accordance with aspects of the present disclosure. 
         FIG. 72  illustrates another perspective view of a portion of a syringe pump in accordance with aspects of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions may be provided in regard to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. 
     It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation. 
     The present system comprises multiple features and technologies that in conjunction form a compounding system that can efficiently reconstitute pharmaceuticals in a sterile environment and deliver the compounded pharmaceutical to a delivery bag for use on a patient. 
       FIG. 1  illustrates a compounder system  10  according to an embodiment.  FIG. 2  illustrates the system  10  with a transparent outer housing  12  and  FIG. 3  illustrates the system with the housing removed. The system comprises a carousel assembly  14  that contains up to 10 individual cartridges  16  (e.g., cassette cartridges). The carousel  14  can hold more or less cartridges  16  if desired. The cartridges  16  are disposable and provide unique fluid paths between a vial  18  containing a powdered drug (or concentrated liquid drug), multiple diluents, and a receiving container. The cartridges  16  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  14  is mounted on the apparatus such that it can rotate to bring different cartridges  16  into alignment with the pump drive mechanism  20 . The carousel  14  is typically enclosed within a housing  12  that can be opened in order to replace the carousel  14  with a new carousel  14  after removing a used one. As illustrated, the carousel  14  can contain up to 10 cartridges  16 , allowing a particular carousel to be used up to 10 times. In this configuration, each carousel assembly can support, for example, 10 to 100 receiving containers, depending on the type of compounding to be performed. For example, for hazardous drug compounding, a carousel assembly can support compounding to ten receiving containers. In another example, for non-hazardous drug compounding such as antibiotic or pain medication compounding, a carousel assembly can support compounding to 100 receiving containers. The housing  12  also includes a star wheel  22  positioned underneath the carousel  14 . The star wheel  22  rotates vials  18  of pharmaceuticals into position either in concert with, or separate from, the specific cartridges  16  on the carousel  14 . The housing  12  may also include an opening  24  for loading the vials  18  into position on the star wheel  22 . 
     Each one of the cartridges  16  in the carousel  14  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. 39  et seq. Each cartridge  16  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  16  also may include a pumping mechanism such as a piston pump for moving fluid and vapor through the cartridge  16  as well as a dual lumen needle in a housing that can pierce a vial puck  26  on top of a vial  18  once the vial  18  has been moved into position by the pump drive mechanism  20 . For example, the needle may pierce the vial puck  26  via the compressive action of the vial puck  26 , which is moved towards the needle. Each cartridge  16  also includes a plurality of ports designed to match up with the needles of a plurality of diluent manifolds. Each cartridge  16  also includes openings to receive mounting posts and a locking bayonet from the pump head assembly  28 . 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  16  also includes openings allowing valve actuators from the pump motor mechanism to interact with the valves on each cartridge  16 . 
     Adjacent the housing  12  that holds the vials  18  and the carousel  14  is an apparatus  30  for holding at least one container  32 , such as an IV bag  32  as shown in the figures. The IV bag  32  typically has two ports such as ports  34  and  36 . For example, in one implementation, port  34  is an intake port  34  and port  36  is an outlet port  36 . Although this implementation is sometimes discussed herein as an example, either of ports  34  and  36  may be implemented as an input and/or outlet port for container  32 . For example, in another implementation, an inlet  34  for receiving a connector at the end of tubing  38  may be provided on the outlet port  36 . In the embodiment shown, the IV bag  32  hangs from the holding apparatus  30 , which, in one embodiment is a post with a hook as illustrated in  FIGS. 1-3 . 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  30  can take any other form necessary to position the IV bag  32  or other pharmaceutical container. Once the IV bag  32  is positioned on the holding apparatus  30 , a first tube  38  (a portion of which is shown in  FIG. 1 ) is connected from a cartridge  16  on the carousel  14  to the inlet  34  of the IV bag  32 . 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  32 . A connector  37  such as a Texium® connector may be provided on the end of tube  38  for connecting to inlet  34  of receiving container  32 . 
     On the opposite side of the compounder  10  is an array of holding apparatuses  40  for holding multiple IV bags  32  or other containers. In the illustrated version of the compounder  10 , five IV bags  42 ,  44  are pictured. Three of these bags  42  may contain diluents, such as saline, D5 W or sterile water, although any diluent known in the art may be utilized. An additional bag in the array may be an empty vapor waste bag  44  for collecting waste such as potentially hazardous or toxic vapor waste from the mixing process. An additional bag  44  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  42  and  44  may each be connected to a cartridge  16  through a disposable manifold. 
     The compounding system  10  also includes a specialized vial puck  26  designed to attach to multiple types of vials  18 . In operation, the vial puck  26  is placed on top of the vial  18  containing the drug in need of reconstitution. Once the vial puck  26  is in place, the vial  18  is loaded into the star wheel  22  of the compounder  10 . Mating features on the vial puck  26  provide proper alignment both while the vial puck  26  is in the star wheel  22  and when the vial puck  26  is later rotated into position so that the compounder  10  can remove it from the star wheel  22  for further processing. 
     The pump drive mechanism  20  is illustrated in  FIG. 4 , and in an exploded view in  FIG. 5 , according to an embodiment. In the embodiment shown in  FIGS. 4 and 5 , the pump drive mechanism  20  comprises a multitude of sections. At one end of the pump drive mechanism  20  is the rotation housing  46 , which holds the drive electronics and includes locking flanges  94  on its housing  96  for flexible tubing  50  which may run from one or more diluent containers and/or waste containers to one or more corresponding manifolds. The rotation housing  46  is capable of rotating around its axis to rotate the rest of the pump drive mechanism  20 . The rotation housing  46  includes bearing ribs  52  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 180°, or more than 180°. 
     The compounder system also includes a diluent magazine that mounts in a slot  60  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  20 . 
     Pump drive mechanism  20  also includes pump head assembly  28 . The pump head assembly  28  includes the vial grasping arms  76 , the vial lift  78 , the pump cartridge grasp  80 , the pump piston eccentric drive shaft  82  with drive pin  222 , the valve actuation mechanisms  84 , as well as the motors that allow the pump drive mechanism  20  to move forward and back and to rotate in order to mix the pharmaceutical in the vial  18  once the diluent has been added to it. The compounder  10  may also include an input screen  86  such as a touch screen  86  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  10  will now be generally described in the flowchart illustrated at  FIG. 8 , according to an embodiment. In the first step  88 , a user inserts a new diluent manifold magazine having a plurality of manifolds (e.g., diluent manifolds and waste manifolds) into the slot  60  on the side of the pump head assembly  28 . Manifolds may be loaded into the magazine before or after installing the magazine in the slot  60 . The manifolds maintain needles inside the housing of the manifold until the cartridge  16  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  92 , 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. 11 , the tubes are held in place with locking flanges  2402  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. 4 , the additional flanges  94  positioned on the outside housing  96  of the pump drive mechanism  20  are provided for securing internal wiring of the compounder. In the next step  98 , waste tubing may be connected to the vapor waste bag  44 . 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  92  and  98  may be omitted. 
     If desired, in the next step  100 , a new carousel  14  may be loaded into a carousel mounting station such as a carousel hub of the compounder system. The carousel  14  may contain any number of disposable cartridges  16  arranged in a generally circular array. In the next step  110 , a vial puck  26  is attached to the top of a vial  18  of a powdered or liquid pharmaceutical for reconstitution and the vial  18  is loaded into the star wheel  22  under the carousel  14  in the next step  112 . Step  110  may include loading multiple vials  18  into multiple vial puck recesses in star wheel  22 . 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  114  is for a user to select the appropriate dosage on the input screen. 
     After the selection on the input screen  86 , the compounder  10  begins operation  116 . The star wheel  22  rotates the vial into alignment  118  with the vial grasping calipers  76  of the pump head assembly  28 . The vial puck  26  includes, for example, gears that interface with gears coupled to a rotational motor that allow the vial  18  to rotate  120  so that a scanner (e.g., a bar code scanner or one or more cameras) can scan  122  a label on the vial  18 . 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  18  is scanned and aligned, in the next step  124  the pump drive mechanism  20  moves forward into position to grip the vial  18  with the calipers  76 . The forward movement also brings the mounting posts  130  and locking bayonet  128  on the front of the pump head assembly  28  into matching alignment with corresponding openings on a cartridge  16 . In the next step  126  the cartridge  16  is locked in place on the pump head assembly  28  with the locking bayonet  128  and the calipers  76  grip  132  the vial puck  26  on the top of the vial  18 . The calipers  76  then remove  132  the vial  18  from the star wheel  22  by moving backward, while at the same time pulling  134  the cartridge  16  off of the carousel  14 . 
     In some embodiments, the cartridge  16  includes a backpack that includes a coiled tube. In this embodiment, in step  136  the pump drive mechanism  20  tilts the cartridge  16  toward the user to expose the end of the tube and prompts  138  the user to pull the tube out of the backpack and connect it to the receiving bag  32 . In an alternative embodiment, the tube  38  is exposed on the side of the carousel  14  once the cartridge  16  is pulled away from the carousel  14 . In another alternative embodiment, the tube  38  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  138  the user to pull the tube out from the carousel  14  and connect it to the input  34  of the IV bag  32 . Once the tube  38  is connected, in step  140  the user may notify the compounder  10  to continue the compounding process by interacting with the input screen  86 . 
     At step  142 , the vial  18  is pulled up towards the cartridge  16  so that one or more needles such as a coaxial dual lumen needle of the cartridge  16  pierce the top of the vial puck  26  and enter the interior of the vial  18 . Although the example of  FIG. 8  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  138  and  140  may be performed after step  142  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  144  into the vial  18  through the cartridge  16  and a first needle in the proper dosage. If necessary, a second or third diluent may be added to the vial  18  via a second or third diluent manifold attached to the cartridge  16 . Simultaneously, vapor waste is pumped  144  out of the vial  18 , through a second needle, through the cartridge  16  and the vapor waste manifold, and into the vapor waste bag  44 . The valve actuators  84  on the pump head assembly  28  open and close the valves of the cartridge  16  in order to change the fluid flow paths as necessary during the process. Once the diluent is pumped into the vial  18 , the pump drive mechanism  20  agitates the vial  18  in the next step  146  by rotating the vial lift  78  up to, for example 180 degrees such that the vial  18  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 180 degrees, a combination of forward-backward, and left-right motion of the pump head may be performed to generate a swirling agitation of the vial. A plurality of default agitation patterns for specific drugs or other medical fluids may be included in the drug library stored in (and/or accessible by) the compounder control circuitry. Once the agitation step is complete, the pump drive mechanism rotates the vial to an upside down position or other suitable position and holds it in place. In some embodiments, a fluid such as a diluent already in the receiving container  32  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  148 , the valve actuators  84  reorient the valves of the cartridge and the pumping mechanism of the cartridge  16  is activated to pump  150  the reconstituted drug into the receiving bag  32  through the attached tube. Once the drug is pumped into the receiving bag  32 , in the next step  152  the pump drive mechanism  20  clears the tube  38  by either pumping filtered air or more diluent through the tube  38  into the receiving bag  32  after another valve adjustment to ensure that all of the reconstituted drug is provided to the receiving bag  32 . In some scenarios, a syringe may be used as a receiving container  32 . In scenarios in which a syringe is used as the receiving container  32 , following delivery of the reconstituted drug to the syringe, a vacuum may be generated in tube  38  by pump drive mechanism  20  to remove any air or other vapors that may have been pushed into the syringe so that, when the syringe is removed from tube  38 , 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  154  the user to remove the tube  38  from the receiving container  32 . 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  14  or the backpack, depending on which type of system is in use. In the next step  156 , the compounder  10  rotates the vial  18  back into alignment with the star wheel  22  and releases it. The used cartridge  16  may also be replaced on the carousel  14 . 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  14  and/or star wheel  22  then may rotate  158  to a new unused cartridge  16  and/or a new unused vial  18  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  16  are designed to be disposable, allowing a user to utilize all the cartridges  16  in a given carousel  14  before replacing the carousel  14 . After a cartridge  16  is used, the carousel  14  rotates to the next cartridge  16 , and the system software updates to note that the cartridge  16  has been used, thus preventing cross-contamination from other reconstituted drugs. Each cartridge  16  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  16 , its flow paths, and its valve construction. 
     An embodiment of a cartridge  16  is illustrated in  FIG. 9 . As shown in  FIG. 9 , cartridge  16  may include a cartridge frame  160 , a cartridge bezel  164 , as well as a piston pump  166 , a needle housing  168  and a needle assembly  170 . The cartridge frame  160  provides the main support for each cartridge  16  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  32 . 
     The frame  160  of the cartridge  16  also includes locating features that allow each cartridge  16  to be removably mounted to the pump head assembly  28 . These features include, for example, three openings  198  to receive mounting posts  130  from the pump head assembly  28 , and a keyhole  210  that allows a locking bayonet  128  to be inserted therein and turned to lock the cartridge  16  to the pump head assembly  28  for removal from the carousel  14 . An outlet port extension  220  may be present in some embodiments. The piston pump  166  is mounted within a chamber with a rod  194  positioned within a silicone piston boot. Furthermore, the bezel  164  includes openings  228  in which the valves  190  of the sealing membrane are located and be accessed by the valve actuators  84 . Moreover, the bezel  164  includes openings  230  that allow a fluid manifold to be connected to the diluent and vapor waste chambers in the cartridge  16 . As discussed in further detail hereinafter, bezel  164  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  230  in the bezel  164  and pierce the sealing membrane to gain fluidic access to the diluent and vapor waste chambers defined in the cartridge  16  between the sealing membrane and the cartridge frame  160 . Further details of various embodiments of the cartridge  16  will be discussed hereinafter. 
     Referring to  FIG. 10 , an exemplary embodiment of a carousel  14  removed from the compounder  10  is illustrated, according to an embodiment. The carousel  14  of  FIG. 10  includes an array of ten cartridges  16  in this embodiment, but it should be understood that more or fewer cartridges  16  can be present on the carousel  14 , leaving some of the carousel  14  pockets  500  empty, or the frame  510  of the carousel can be designed to have more or fewer cartridge pockets  500 . In some implementations, the carousel  14  may also, optionally, include a cover  511  that prevents a user from accessing the tubes coupled to each of the cartridges  16  directly. In these implementations, the cover  511  may be removed if necessary to access the backs of the cartridges  16 . In the example implementation of  FIG. 10 , a connector such as a Texium® attachment  548  is disposed adjacent each cartridge  16 , the attachment  548  being attached to the tube  38  that runs from the extension  220  on each cartridge  16 . 
       FIGS. 11-14  show the compounder  10  according to another embodiment. As shown in  FIG. 11 , holding apparatus  40  may be implemented as an extended arm providing support for mounting devices for each of containers  42  and  44 . Holding apparatus  40  and holding apparatus  30  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  2404  may be provided with which each diluent container and/or the receiving container can be scanned before and/or after attachment to compounder  10 . As shown in  FIG. 11 , a carousel cover  2400  and tube management structures  2402  may also be provided on compounder  10  in various embodiments. For example, tubes connected between containers  42  and/or  44  and corresponding manifolds can each be mounted in a groove of tube management structure  2402  to prevent tangling or catching of the tubes during operation of compounder  10 . 
     An opening may be provided by which vials  18  can be installed in the star wheel. Additionally, an exterior pump  2500  may be provided for pumping non-toxic liquid waste from, for example, receiving container  32  to a waste container  44  (e.g., for pumping a desired amount of saline out of receiving container  32  quickly and without passing the liquid waste through a cartridge and/or other portions of the compounder). 
     A fluidics module  2504  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  10  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. 12 , pump  2500  and display  86  may be mounted to a chassis  2600 . Pump drive  20  may be mounted partially within the chassis  2600  with pump head assembly  28  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  14  is also shown in  FIG. 12  without any cartridges mounted therein so that cartridge mounting recesses  500  can be seen. 
     Star wheel  22  (sometimes referred to herein as a vial tray) is shown in  FIG. 12  with several empty vial puck recesses  2604 . Vial tray  22  may be rotated and an actuating door  2608  may be opened to facilitate loading of vials  18  into the vial puck recesses  2604  in vial tray  22 . In some embodiments, door  2608  may be closed before rotation of vial tray  22  to ensure that the operator&#39;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  2650  (e.g., a light curtain) may be provided instead of (or in addition to) door  2608  to sense the presence of an operator in the vicinity of tray  22  and prevent rotation of the tray if the operator or any other obstruction is detected. 
     Similarly, a lid may be provided for carousel  14  to prevent contamination of cartridges  16  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  14  may be prevented if the lid is not detected in a closed position by the lid sensor. 
     Each vial  18  that is inserted may be detected using a sensor such as sensor  2652  (e.g., a load sensor or an optical sensor) when placed in a vial puck recess  2604 . When detected, the inserted vial may be moved to a scanning position by rotating vial tray  22  and then the inserted vial  18  may be rotated within its position in vial tray  22  using a vial rotation motor  2602  to allow the vial label to be scanned. 
     A reverse perspective view of compounder  10  is shown in  FIG. 13  in which scanning components can be seen. In particular, a camera  2700  is mounted in an opening in chassis  2600  and configured to view a vial  18  in a scanning position. Motor  2602  may rotate vial  18  through one or more full rotations so that camera  2700  can capture images of the vial label. In some embodiments, an illumination device  2702  (e.g., a light-emitting diode or other light source) may be provided that illuminates vial  18  for imaging with camera  2700 . 
     As shown in  FIG. 13  one or more gears  2704  coupled to motor  2602  may be provided that engage corresponding gears on a vial puck  26  to which a vial  18  is attached at the scanning position. The vial tray  22  may be rotated so that the vial puck gears engage the rotation motor gears so that when the motor  2602  is operated the vial  18  is rotated. 
       FIG. 13  also shows how a magazine  2706  containing one or more manifolds may be mounted in a recess in pump head assembly  28 . A magazine slot in magazine  2706  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  2706  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  2750  (e.g., an optical sensor) may be provided in the manifold recess in pump head assembly  28 . Manifold sensor  2750  may be configured to detect the presence (or absence) of a manifold in a manifold recess (slot) in magazine  2706  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  2708  such as valve actuators, needle actuators, mounting posts, a locking bayonet, and a drive pin can also be seen extended from pump head assembly  28  which are configured to secure and operate a pump cartridge  16 . 
     Compounder  10  may include additional components such as a chassis base and chassis housing, and an internal electronics assembly. Pump drive  20  may be seated in an opening in the chassis housing that allows pump head assembly  28  to protrude from the chassis housing. Processing circuitry for managing operations of compounder system  10  may be included in the electronics assembly. 
     Carousel  14  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  20 . The vial tray and carousel drive assembly may include separate drive assemblies for the vial tray and for the carousel such that vial tray  22  and carousel  14  may be rotated independently. 
       FIG. 14  shows another perspective view of compounder  10  highlighting the locations of various particular components such as the carousel  14  with cartridges  16  mounted therein, a cartridge  16  having a backpack  2900 , a vial puck  26  for mounting vials  18 , and pump head assembly  28  with a diluent magazine  2706  containing a plurality of manifolds  2906  in accordance with an embodiment. Further features of compounder  10  will be described hereinafter in connection with  FIGS. 15-73  in accordance with various embodiments. 
     The cartridges  16  are designed to be disposable, allowing a user to utilize all the cartridges  16  in a given carousel  14  before replacing the carousel  14 . After a cartridge  16  is used, the carousel  14  rotates to the next cartridge  16 , and the system software updates to note that the cartridge  16  has been used, thus preventing cross-contamination from other reconstituted drugs. Each cartridge  16  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 the 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  16 , its flow paths, and its valve construction. 
     Various embodiments of a cartridge  16  are illustrated in  FIG. 15-20B . A fully constructed cartridge  16  is shown in  FIGS. 15 and 16  in one embodiment. A cartridge  16  having a tube management structure implemented as a backpack for the cartridge is shown in  FIGS. 17 and 18 . An exploded version of a cartridge  16  is illustrated in  FIG. 19  and shows three main portions of the cartridge  16 : the cartridge frame  160 , the cartridge sealing membrane  162 , the cartridge bezel  164 , as well as the piston pump  166 , the needle housing  168  and the needle assembly  170  according to an embodiment. A fully constructed cartridge  16  is shown in  FIGS. 20A and 20B  in one embodiment. Various features of the cartridge of  FIGS. 19, 20A, and 20B  are shown in  FIGS. 21-31 . 
     As shown in  FIG. 15 , a front view of the cartridge  16  is illustrated. Cartridge frame  160  provides the main support for each cartridge  16 . Piston pump  166  and a cartridge needle housing  168  to hold the needle assembly  170  are provided that can be operated to move liquids and waste vapor to and from vial  18  during reconstitution and filling of receiving container  32 . Valves  190  are positioned with respect to various internal flow paths within cartridge  16  for diluents, vapor waste, filtered air, and reconstituted drugs and are operable to modify and control the internal flow paths when desired. 
     Frame  160  of the cartridge  16  also includes locating features that allow each cartridge  16  to be removably mounted to the pump head assembly  28 . These features include three openings  198  to receive mounting posts  130  from the pump head assembly  28 , and a keyhole  210  that allows a locking bayonet  128  to be inserted therein and turned to lock the cartridge  16  to the pump head assembly  28  for removal from the carousel  14 . 
     The cartridge needle housing  168  extends from the bottom of the cartridge frame  160  and may be designed to be removable by snapping a pair of locking flanges  214  on the needle housing  168  into flange openings  216  in the cartridge frame  160 . The cartridge needle housing  168  is designed to prevent accidental user contact with the needle assembly  170  and to maintain the sterility of one or more needles of the needle assembly (see, e.g., needles  316  and  318  of  FIG. 31 ). The needle housing  168  also receives the vial puck  26  in a position to allow the needles to pierce the vial puck  26 . 
     A sealing membrane may be disposed between frame  160  and bezel  164  to form sealed internal flow paths in cartridge  16  in cooperation with internal features of frame  160  and bezel  164  as described in further detail hereinafter. 
     Before describing the various fluid flow paths in the cartridge  16 , the operation of the pumping and valve mechanisms will be described with reference to  FIGS. 3, 4, 6 and 7 . A piston pump such as piston pump  166  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&#39;s orientation or environmental conditions. Second, it is able to push an excess of 50 psi into elastomeric pumps. The piston pump  166  may be positioned within the cartridge  16  in a silicone piston pump boot. The pump mechanism is driven by a motor in the pump motor mechanism  20  which rotates an eccentric drive shaft  82  and drive pin  222  on the pump head assembly  28  which controls the movement of the piston  166  as well as the valve actuators  84 . In operation, the cartridge  16  is placed on the cartridge grasp  80  on the locating posts  130  and locked in place by the locking bayonet  128 . This aligns the valves disposed in openings  228  of bezel  164  with the valve actuators  84  and the eccentric drive shaft  82  and pin  222  with the piston pump  166 . The piston  166  is driven by the eccentric drive pin  222 . The pin  222  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  166 . 
     The valve actuators  84  are illustrated in  FIGS. 6 and 7 , which show the pump head assembly  28  removed from the rest of the pump motor mechanism  20 . Each one of the valves in openings  228  has a corresponding valve actuator  84  that is controlled by a geared cam to cause axial movement of the valve actuator  84  into contact with the valve to close the valve and away from the valve to open the valve. In one embodiment, eight valve actuators  84  are provided, one for each valve, and they are aligned with the positions of the valves so they can extend through the openings  228  in the bezel  164  of the cartridge  16  and contact the valves. The valve actuators  84  are software controlled so that they can automatically cause the valves to open and close depending on which internal flow paths within cartridge  16  are to be opened and closed. 
     The valve actuators  84  are operated at different times in the pumping cycle depending on the required fluid flow path. The fill portion of the piston  166  starts as the piston rod  194  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  166  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  166  moves in the opposite direction. The delivery portion of the cycle ends when the piston  166  reaches the top dead center location, which is the home location. When the piston  166  reaches this position, a new cycle is started. 
     The movement of the eccentric drive shaft  82  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 50 psi. 
     An alternative embodiment of the cartridge  16  utilizing a “backpack” to coil the flexible tubing  38  is illustrated in  FIGS. 17 and 18 . The backpack  298  is attached to the back of the cartridge frame  160  and one end of the flexible tube  38  is attached to an outlet port on the back of the cartridge frame  16 . The backpack  298  comprises a housing  310  and may include a tube control mechanism defined in a chamber that can rotate or otherwise operate to coil the flexible tubing  38 . At the opposite end of the tubing from the outlet port is a connector  300  (e.g., an ISO Luer connector such as a Texium® attachment) that a user can pull out of the backpack  298  and attach to the receiving bag  32 . In some embodiments, the tubing attached to the connector  300  may be automatically extended from within backpack  298  to facilitate attachment by the user. Upon completion of the filling of the bag  32 , the tube control mechanism can draw the flexible tubing  38  back into the backpack  298  and out of the way so that the next cartridge  16  in the carousel  14  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. 19 , an exploded perspective view of another embodiment of cartridge  16  shows three main portions of the cartridge  16 : the cartridge frame  160 , the cartridge sealing membrane  162 , the cartridge bezel  164 , as well as the piston pump  166 , the needle housing  168  and the needle assembly  170 . In the example of  FIG. 19 , cartridge bezel  164  includes an additional opening  3022  to provide access to a pressure dome formed on membrane  162  to allow sensing of pressure in the fluid pathways of cartridge  16 . An air-in-line sensor fitment  3000  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  16  may be provided with gas flow control structures such as an air filter  3006  and one or more check valve discs  3004  that mount to frame  160  with a check valve cover  3002 . Air filter  3006 , check valve discs  3004 , and check valve cover  3002  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. 19 , piston  166  may include a piston boot  3007  that, for example, provides one or more moveable seals (e.g., two moveable seals) for controlling the volume of a pump chamber when piston  166  is actuated.  FIG. 19  also shows various structures for control of another embodiment of needle housing  168  in which needle assembly  170  includes a dual lumen needle with a first needle overmold  317 A, a second needle overmold  317 B, a needle spring  3014 , and a needle membrane  3008 . An opening  3020  in bezel  164  may be provided that aligns with a corresponding opening  3021  in frame  160  to allow a view through cartridge  16  (e.g., by a sensor of the pump drive mechanism) into a backpack that is mounted to cartridge  16  as will be described in further detail hereinafter. A protrusion  3016  formed on a top side of cartridge frame  160  may be provided as a mounting structure for the backpack. 
       FIGS. 20A and 20B  show assembled views of the cartridge embodiment shown in  FIG. 67  from the bezel side and frame side respectively in which an opening  3120  (formed by openings  3020  and  3021  of  FIG. 19 ) that allows a view completely through cartridge  16  can be seen. As shown in  FIG. 20A , in some embodiments, cartridge  16  may include four diluent and waste ports  3100  and a pressure dome  3101 . For example, three of the ports  3100  may be configured as diluent ports and one of the ports  3100  may be configured as a waste port. A pressure sensor in the pump head assembly  28  may determine pressure within the fluid pathways in cartridge  16  by contacting pressure dome  3101 . Each of the ports  3100  may be formed from an opening in bezel  164  and a chamber located behind a portion of membrane  162  in frame  160 . 
       FIG. 21  is a cross-sectional perspective side view of an assembled cartridge  16  having a backpack  3202  (e.g., an implementation of backpack  2900  of  FIG. 14 ) attached thereto to form a cartridge and backpack assembly  3203 . As shown in  FIG. 21 , protrusion  3016  may extend into an opening  3201  in the backpack  3202  to latch the backpack to cartridge  16  at the top side. Additional latching structures at the bottom side will be described in further detail hereinafter. An additional structure  3200  may be disposed between backpack  3202  and cartridge  16 . Structure  3200  may be substantially planar and may be shaped and positioned to latch cartridge and backpack assembly  3203  to carousel  14 . For example, protrusions  3206  that extend from the top of the backpack  3202  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  3206  when cartridge and backpack assembly  3203  is pushed into the carousel until protrusions  3206  snap up into a locked position to secure the cartridge and backpack assembly in the carousel. To remove cartridge and backpack assembly  3203  from the carousel for compounding operations, a bayonet  128  that extends into opening  210  may be turned to lower protrusions  3206  to release the cartridge and backpack assembly from the carousel. Further features of the coupling of cartridge and backpack assembly  3203  to the carousel will be described hereinafter. 
     Tubing (e.g., flexible tubing  38 ) for fluidly coupling cartridge  16  to a receiving container  32  may be housed within backpack  3202 . For example, the tubing may be coupled at an output port  180  (e.g., a receiving container port—see, e.g.,  FIG. 20B ) to cartridge  16 , coiled within an internal cavity of backpack  3202 , and extend through opening  3210  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  3204  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  86 ) an operator may remove the connector from opening  3204 , pull the tubing from within backpack  3202 , 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  10  may include a sensor such as an optical sensor that determines whether the connector is present within opening  3204  (e.g., by viewing the connector through opening  3120 ). 
     Compounder  10  may determine, based on whether the connector is within opening  3204 , 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  3204 . Backpack  3202  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  3204 , the pump drive mechanism  20  may operate one or more coiling mechanisms within backpack  3202  to pull the extended tubing back into the backpack and may turn the bayonet to lower protrusions  3206  so that the cartridge and backpack assembly can be returned to the carousel. 
       FIG. 21  also shows an enlarged view of a portion of cartridge  16  with the cross-section taken through two of valves  190  within openings  228  in bezel  164 . As shown in the enlarged view, each valve  190  may be formed from a raised portion  6908  of sealing membrane  162  that extends from a planar portion  6906  of sealing membrane  162  into a corresponding opening  228  in cartridge bezel  164 . In the example shown in, for example,  FIGS. 19-21 , raised portion  6908  is a pyramid-shaped dome formed in opening  228 . In a portion of the fluid path  6900  formed between sealing membrane  162  and frame  160  adjacent each valve  190 , frame  160  may include a rib  6902  in spaced opposition to the raised portion  6908  of the sealing membrane for that valve. When raised portion  6908  is in a raised position, fluid and/or vapor can flow over rib  6902  through the open valve. In operation, a valve actuator  84  that extends from and is operable by pump head assembly  28  can extend through opening  228  to compress raised portion  6908  against rib  6902  to close the valve and prevent fluid from flowing therethrough. 
       FIG. 22  is a cross-sectional side view of the cartridge showing piston pump  166 . As shown in  FIG. 22 , piston pump  166  may include a silicon boot  7100  having first and second seals  7102  and  7104 . Forward seal  7104  may form a moving boundary of a pump chamber  6106 . Rearward seal  7102  may prevent dust or other contaminants from contacting forward seal  7104 . Pump chamber  7106  may be formed adjacent one or more valves  190  (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. 23 , for purposes of discussion herein, valves  190  are labeled in three valve groups V 1 , V 2 , and V 3 . Valve group V 1  may be a diluent valve group having three valves P 1 , P 2 , and P 3 . Valve group V 2  may be a reconstitution valve group having three valves P 1 , P 2 , and P 3 . Piston pump valves P 1  and P 2  of valve group V 3  (e.g., a piston pump valve group) may be operated alternately in cooperation with piston pump  166 . For example, during a forward stroke of piston pump  166 , valve V 3 /P 1  may be closed and valve V 3 /P 2  may be open and during a backward stroke of piston pump  166 , valve V 3 /P 1  may be open and valve V 3 /P 2  may be closed to pump fluid in a first direction within the fluid pathways of cartridge  16 . In another example, to pump fluid in an opposite, second direction within the fluid pathways of cartridge  16 , during a forward stroke of piston pump  166 , valve V 3 /P 1  may be open and valve V 3 /P 2  may be closed and during a backward stroke of piston pump  166 , valve V 3 /P 1  may be closed and valve V 3 /P 2  may be open. 
       FIGS. 24-27  show various examples of valve configurations for pumping fluids through cartridge  16  for various portions of a compounding operation using the valve labels shown in  FIG. 23  for reference. In the example of  FIG. 24 , the valves of valve groups V 1  and V 2  are configured for pumping diluent from a diluent container directly to a receiving container (e.g., valves P 1  and P 3  of group V 1  are closed, valve P 2  of group V 1  is open, valves P 1  and P 2  of group V 2  are closed, and valve P 3  of group V 2  is open to form a fluid path  7300  from one of diluent ports  3100  to receiving container port  7302 ). 
     In the example of  FIG. 25 , the valves of valve groups V 1  and V 2  are configured for pumping diluent from a diluent container to a vial for reconstitution operations (e.g., valves P 1  and P 3  of group V 1  are closed, valve P 2  of group V 1  is open, valves P 2  and P 3  of group V 2  are closed, and valve P 1  of group V 2  is open to form a fluid path  7400  from one of diluent ports  3100  to vial port  7402 ). As shown, during reconstitution operations, a hazardous vapor path  7404  may be formed from a vial waste port  7406  to waste port  3100  to be provided to waste container  44 . In some embodiments, a non-hazardous waste path  7408  may be provided from a non-hazardous vial waste port  7405  to air filter port  7410 . However, this is merely illustrative. In some embodiments, air filter port  7410  may be associated with air filter check valve structures  3004 ,  3004 , and  3006  that prevent flow of any vapor waste along path  7408  and ensure that all vapor waste from vial  18  is moved along path  7404  through waste port  3100 . 
     In the example of  FIG. 26 , the valves of valve groups V 1  and V 2  are configured for pumping a reconstituted drug from a vial to a receiving container for compounding operations (e.g., valves P 1  and P 2  of group V 1  are closed, valve P 3  of group V 1  is open, valves P 1  and P 1  of group V 2  are closed, and valve P 3  of group V 2  is open to form a fluid path  7500  from vial port  7402  to receiving container port  7302 ). As shown, during compounding operations, a path  7502  may be formed from air filter port  7410  to non-hazardous vapor vial port  7405  to provide filtered, sterile air from outside cartridge  16  into the vial to prevent a vacuum from being generated when the drug is pumped from the vial. 
     Although the receiving container  32  is shown in, for example,  FIGS. 1, 3, and 11 , as an IV bag, in some scenarios, the receiving container  32  may be implemented as a syringe. For example, a Texium® connector coupled by tubing to an output port such as receiving container port  7302  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. 27 , the valves of valve groups V 1  and V 2  are configured for pumping air from a receiving container such as a syringe (e.g., valves P 1  and P 3  of group V 1  are closed, valve P 2  of group V 1  is open, valves P 2  and P 3  of group V 2  are closed, and valve P 1  of group V 2  is open to form a fluid path  7600  from receiving container port  4302  to waste port  3100 ). In some configurations, the valves P 1  and P 2  of group V 3  may be alternately opened and closed in cooperation with the motion of piston pump  166  to move the desired fluid or vapor along the fluid pathways defined by valves  190 . 
       FIG. 28  is a chart showing the position and operation of the valves  190  as labeled in  FIG. 23  during various portions of a reconstitution/compounding process as described above in connection with  FIGS. 24-27 . 
       FIG. 29A  is a cross-sectional side view of cartridge  16  with the cross section take through diluent ports  3100 D, waste port  3100 W, and receiving container port  7302 . As shown in the example of  FIG. 29A , each diluent port  3100 D may be formed by a portion of membrane  162  that is formed within an opening in bezel  164  and adjacent to a diluent chamber  8200 D. Waste port  3100 W may be formed by a portion of membrane  162  that is formed within an opening in bezel  164  and adjacent to a vapor waste chamber  8200 W. Receiving container port  7302  may be formed from an opening that leads to a receiving container chamber  8202  in which tubing that extends into backpack  3202  may be disposed to form a fluid path to the receiving container from cartridge  16 . 
     When compressed by a sealing manifold membrane such as sealing manifold membrane  8252  of manifold  8250  of  FIG. 29B , the portion of sealing membrane  162  that forms diluent and/or waste ports  3100  creates a drip-free connection between the manifold  8250  and the cartridge. A manifold needle  8254  of a selected diluent manifold  8250  and a manifold needle of a waste manifold can extend through the corresponding manifold membrane  8252  and the sealing membrane  162  in the respective diluent and waste port to form fluid paths through sealing membrane  162  (e.g., through opening  8256 , central bore  8257 , and opening  8258  of needle  8254 ) for diluents and waste vapors for reconstitution and compounding operations. 
     However, the example of  FIG. 29A , in which the seal of ports  3100 D and  3100 W are formed solely by a portion of membrane  162  that extends into an opening in bezel  164  is merely illustrative. In some embodiments, in order to provide an improved drip-free seal, the seal of each of ports  3100 D and port  3100 W 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  16 . 
       FIG. 29C  shows a cross-sectional view of a port of cartridge  16  in an implementation with three sealing members. As shown in  FIG. 29C , a port  3100  (e.g., one of diluent port  3100 D or waste port  3100 W) may be formed from a portion of membrane  162  that is disposed between an outer sealing member  8262  (formed in an opening  8260  in bezel  164 ) and an inner sealing member  8264 . Inner sealing member  8264  may be disposed between membrane  162  and chamber  8200 . 
     As shown in  FIG. 29C , outer sealing member  8262  may include a portion that extends through opening  8260  and may also include a recess  8268  on an interior surface adjacent to membrane  162 . Membrane  162  may also include a recess  8266  on an interior surface adjacent to inner sealing member  8264 . Providing a port  3100  with multiple sealing members such as the three sealing members (i.e., member  8262 , member  8264 , and the portion of membrane  162  formed between members  8262  and  8264 ) may provide an enhanced wiping of needle  8254  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  8266  and  8268  may further increase the efficiency of the wiping of needle  8254 , however, in various embodiments, sealing members may be provided with or without recesses  8266  and/or  8268 . 
       FIG. 29D  shows the manifold  8250  with manifold sealing member  8252  compressed against outer sealing member  8262  of port  3100 . As shown in  FIG. 29D , needle  8254  is extended from manifold  8250  through sealing members  8252  and  8262 , through interstitial space  8268 , through membrane  162 , through interstitial space  8266 , and through inner sealing member  8264  such that openings  8256  and  8258  and central bore  8257  form a fluid pathway between cartridge  16  and manifold  8250 . 
     In the example of  FIG. 29A , the portion of membrane  162  that extends into the openings in bezel  164  in ports  3100  may be compressed (e.g., compressed by 10% 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  FIGS. 29C and 29D , the portion of sealing member  8262  that extends into the openings in bezel  164  in ports  3100  may be compressed (e.g., compressed by 10% 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  FIGS. 29C and 29D  may be arranged to each provide a wiping effect on needle  8254  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. 30  is cross-sectional perspective side view of cartridge and backpack assembly  3203  in which protrusion  3016  and protrusion  3304  of cartridge frame  160  can be seen cooperating to couple cartridge  16  to backpack  3202  to form cartridge and backpack assembly  3203 . To install backpack  3202  onto cartridge  16 , opening  3201  of backpack  3202  can be positioned over protrusion  3016  and backpack  3202  can be rotated (e.g., in a direction  3401 ) to push latching features  3302  of backpack  3202  against latching protrusion  3304  until latching protrusion  3304  snaps into position between latching features  3302 . As shown, protrusion  3016  may be formed on an additional latching structure of cartridge  16  such as a flexible arm  3400 . Flexible arm  3400  may allow backpack  3202  to be pulled downward by a small distance when backpack  3202  is rotated to press latching feature  3302  onto protrusion  3304 . Flexible arm  3400  may be resilient to maintain an upward force the holds latching features  3302  in a latched position against protrusion  3304 . 
     In the example of  FIG. 30 , a vial  18  and vial puck  26  are positioned adjacent to cartridge and backpack assembly  3203  with needle assembly  170  extended into the vial through sealing member  3402  of cartridge  16  and sealing member  3404  of vial puck  26  which may provide a drip free seal and allow fluid to be provided into and/or removed from vial  18 . Sealing member  3402  may be, for example, an implementation of sealing member  3008 . As shown, when the needle assembly  170  is extended into the vial, portions of the vial puck  26  may be located adjacent to latching features  3302  of backpack  3202 . 
       FIG. 31  shows a cross-sectional view of a portion of cartridge  16  along with an enlarged view of a portion of needle assembly  170 . As shown in  FIG. 31 , needle housing  186  may include a sealing membrane  3402  formed within an annular housing member  8404  that is attached to cartridge frame  160  via one or more housing arms  8408 . A spring  8410  may be provided that extends from needle housing  317 B into needle housing  186  such that compression of spring  8410  is necessary to extend needles  316  and  318  through sealing membrane  3402 . In this way, a user handling cartridge  16  is prevented from being injured by access to needle assembly  170 . In operation, a vial puck may be pressed against annular housing member  8404  to compress spring  8410  such that needle assembly  170  extends through sealing membrane  3402  and through a sealing membrane of the vial puck into the vial. 
     Dual lumen needles  316  and  318  may be respectively provided with openings  8400  and  8402  that provide fluid access to central bores of the needles. Needle  316  may, for example, be a 24 gauge needle held in cartridge frame  160  by a high density polyethylene (HDPE) overmold  317 A, the needle having an opening  8400  for venting the drug vial. Opening  8400  may be formed using a slot cut as shown to reduce coring of the sealing membranes as the needle is inserted and retracted. Needle  318  may, for example, be an 18 gauge needle held in cartridge frame by a high density polyethylene (HDPE) overmold  317 B with one or more openings  8402  for fluid flow into and/or out of the vial. Openings  8402  may include two drilled holes configured to reduce coring and to allow up to, for example, 60 mL/min of fluid flow. 
     In this way, during reconstitution operations, diluent may be provided into the vial via openings  8402  of needle  318  and vapor waste may be simultaneously extracted from the vial via opening  8400  in needle  316 . During compounding operations, a reconstituted drug may be pulled from the vial via openings  8402  of needle  318  and sterile air may be provided into the vial via opening  8400  of needle  316 . 
     Various aspects of a dry disconnect are described (e.g., a dry disconnect between cartridge  16  and vial  18  via vial puck  26 ). For example, a dry disconnect can be achieved when the needle of cartridge  16  is wiped or “squeegeed” clean as it retracts through sealing membranes of puck  26  and cartridge  16 . However, compounder  10  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  18 . 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,  FIGS. 32-35  show an exemplary implementation of a vial puck  13202  (e.g., an implementation of vial puck  26 ) that includes a hydroscopic member  13210  in addition to a sealing membrane  13200  (e.g., an implementation of sealing membrane  3402 ). 
     In the example of  FIGS. 32-35B , a single lumen needle  13204  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  FIGS. 32-35B , vial septum  13208  of vial cap  13206  works in conjunction with vial puck membrane  13200  to “squeegee” any fluid from the outside of the needle. Additionally, as shown in the cross-sectional view of  FIG. 32 , located between vial puck membrane  13200  and vial septum  13208  is a hydroscopic material  13210  (e.g., a sponge) that is “feature flexible,” allowing hydroscopic material  13210  to absorb fluid in hard to reach areas of needle  13204  such as corners and fluid passage openings. 
     For example,  FIG. 33  shows a cross-sectional view of a configuration in which opening  13334  of needle  13204  is disposed within hydroscopic material  13210  during retraction of the needle from vial cap  13206  while sealing membrane  13200  wipes a portion of the needle at interface  13300  and vial septum  13208  wipes another portion of needle  13204  at interface  13336 . Absorbing fluid in hard to reach areas as shown in  FIG. 33  allows a greater chance of a good dry disconnect as the vial needle is retracted. 
       FIG. 34  shows a partially transparent view of puck  13202  and vial cap  13206  in which the exterior side of puck  13202  and a portion of vial puck membrane  13200  are visible (within the housing of puck  13202  shown in partial transparency to allow viewing of hydroscopic material  13210 ) with a needle having a bevel cut  13402  passing through vial puck membrane  13200 , hydroscopic material  13210  and vial septum  13208 . 
       FIG. 35A  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  13500 .  FIG. 35B  shows an exemplary implementation in which a stack  13502  of hydroscopic media with slits can be provided spaced apart from the puck sealing membrane. 
     Having hydroscopic material  13210  sandwiched between vial puck membrane  13200  and vial septum  13208  allows a successful dry disconnect to be made with various vial needle configurations and sizes. For example, coaxial needles  316  and  318  described herein (see, e.g.,  FIG. 31 ) 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  13210  allows the needle interface step area to be cleared of fluid prior to needle extraction. 
     In addition to providing hydroscopic material  13210  in puck  13202 , in some implementations, prior to pulling needle  13204  completely from vial septum  13208 , a slight vacuum may be constantly pulled on the fluid needle  13204  (as indicated by arrow  13600  of  FIG. 36 ) to clear the needle&#39;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  13204  and the membrane passages 
     For example, as shown in  FIG. 37 , fluid  13708  that may be disposed between needle  13204  and puck sealing membrane  13200  may be pulled into needle  13204  by a vacuum as the side port  13334  of needle  13204  travels through membrane  13200 , so that the surface  13702  of needle  13204  is dry. In implementations in which a vacuum is applied to during retraction of needle  13204 , needle  13204  may be provided with openings configured to facilitate the vacuum features (e.g., needle  130204  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  26 / 13202  with a hydroscopic medium and/or an internal vacuum pressure, to help ensure a dry disconnect, cartridge  160  may be provided a bellows that surrounds needle  13204  (or needles  316 / 318 ).  FIGS. 38-43  show various views of a needle assembly that includes a bellows.  FIG. 38  shows a perspective view of an exemplary implementation of cartridge  16  having a needle assembly  170  with bellows  13800  that surrounds the needle (and having dial valves instead of membrane valves).  FIG. 39  shows bellows  13800  in partial transparency so that the position of needle  13204  within bellows  13800  can be seen. Needle  13204  in the examples of  FIGS. 38-43  may be implemented as a dual lumen needle formed from metal or plastic. 
       FIG. 40  shows bellows  13800  again in partial transparency and shows how an internal extension spring  14000  within bellows  13800  and around needle  13204  may be provided to bias bellows  13800  in an extended configuration in which needle  13204  is completely surrounded by (and sealed within) bellows  13800  (e.g., in the absence of an external force that overcomes the tension of spring  14000 ). As shown in  FIG. 41 , bellows  13800  may be bonded to a lower surface  14102  (e.g., a lower surface of cartridge frame  160 ) to form an airtight seal with lower surface  14102 . 
     Bellows  13800  may be formed from silicone or other flexible materials. Bellows  13800  may also include a dry disconnect mating area  14104  configured to mate with a vial or vial puck dry disconnect feature. As shown in  FIG. 42 , dry disconnect mating area  14104  may include a seal  14200  configured to be pierced by needle  13204  when vial lift  78  lifts a vial/vial puck assembly toward cartridge  16  (e.g., in direction  14202 ) to compress bellows  13800  while needle  13204  remains fixed. In the configuration shown in  FIG. 42 , seal  14200  maintains a sealed cavity within bellows  13800 . 
     As a vial/vial puck assembly is pulled towards cartridge  16 , bellows  13800  compresses until eventually needle  13204  protrudes through all of the dry disconnects. Later, as the vial/vial puck assembly is retracted (e.g., in direction  14300  of  FIG. 43 ) and needle  13204  is extracted, bellows  13800  begins to expand and create a slight vacuum within cavity  14204  of bellows  13800 . This vacuum helps pull in any remaining fluid between needle  13204  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  13204  may be a dual-lumen plastic needle.  FIGS. 44-50  show various views of an exemplary implementation of a dual-lumen plastic needle for cartridge  16 . As shown in the partial transparency side view of  FIG. 44 , needle  13204  may be provided with an upper fluid port  14400 , a lower fluid port  14404 , an upper vent port  14402 , and a lower vent port  14406 .  FIG. 45  shows a cross-sectional view of needle  13204  in which divider  14500  can be seen separating the fluid side (fluid pathway) from the vent side (vent pathway) of the needle. As shown in  FIG. 46 , one or more internal features such as a ledge  14600  may be provided as guide to aid in installation of divider  14500 . As shown in  FIG. 47 , needle  13204  may be provided with energy directors  14700  on the upper fluid and vent ports for ultrasonic welding of the ports to corresponding fluid and vent paths within cartridge  16 . As shown in  FIG. 48 , needle  13204  may be provided with a smooth needle tip  14800  to prevent coring of sealing membranes.  FIG. 49  shows a top-side perspective view of needle  13204  with divider  14500 . Divider  14500  may be solvent bonded to the main body of the needle or may be integrally formed with the main body. As shown in  FIG. 50 , additional channel definition members such as channel definition member  15000  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  15000  may be integrally formed with the main body of the needle or may be separate members. 
     In the example of  FIGS. 44-50 , cartridge  16  interacts with a vial  18  containing a drug using a dual lumen vial/vent plastic needle  13204 . Needle  13204  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  13204  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  13204  in the examples of  FIGS. 44-50  includes fluid port  14404  and vent port  14406  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  13204  may be a two piece plastic needle that is composed of the main body and a divider (e.g., divider  14500 ) 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  14404  and  14406  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  14404  and  14406  may also be located 180 degrees to each other for moldability (see, e.g.,  FIG. 44 ). 
     Although various implementations have been described in which a needle for coupling cartridge  16  to vial  18  through vial puck  26  is disposed in the cartridge, it should be appreciated that, in other implementations, the needle or a cannula may be disposed in vial puck  26  for coupling vial  18  to cartridge  16 .  FIGS. 51-63  show various views of an exemplary implementation in which a dual-lumen cannula is disposed in puck  26 . For example,  FIGS. 51 and 52  respectively show side and perspective views of vial puck  26  with an incorporated cannula (not visible in  FIGS. 51 and 52 ; see  FIGS. 53 and 54 ) and two dry disconnect valves  15102  and  15104  used to make the mate between vial  18  and cartridge  16 . 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  26  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  FIGS. 51 and 52 , 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  26 , a protrusion  15100  on cartridge  16  advances the cannula into vial  18 . 
     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  15102  and  15104  that allow for a needless fluid transfer to and from vial  18 . 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  18 , 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  FIGS. 51-63 , when fluid is added to vial  18  from cartridge  16 , this air is displaced through the aforementioned dry disconnect valve. When fluid is removed from vial  18 , ambient air is introduced to vial  18  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  FIGS. 51-63 , may also eliminate the use of a needle in cartridge  16  and allow for a wider range of flow rates while maintaining a leak-free seal at disconnection. 
       FIG. 53  shows a side view of an exemplary implementation of a dual-lumen plastic cannula  15400  that may be provided within puck  26  to be actuated by protrusion  15100 .  FIG. 54  shows a cross-sectional view of cannula  15400  in which a fluid path  15402  and an air/vent path  15404  are visible.  FIG. 55  shows a partially transparent side view of puck  26  attached to vial  18  in which cannula  15400  is completely disposed within puck  26  and vial  18  has not yet been accessed.  FIG. 56  shows a partially transparent side view of puck  26  attached to vial  18  in which cannula  15400  has been extended into vial  18  by protrusion  15100  on puck  26 .  FIG. 57  shows a bottom side perspective view of puck  26  in which cannula  15400  is completely disposed within opening  15500  of puck  26 .  FIG. 58  shows a bottom side perspective view of puck in which cannula  15400  has been extended into recess  15600  of puck  26 , recess  15600  being configured to attach to the top of a vial  18 . 
     The retracted state of  FIGS. 55 and 57  allows puck  26  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  26  with a needle or cannula  15400  incorporated into vial puck  26 , can help reduce the risks of coring the vial stopper as the vial is only accessed by the needle/cannula a single time. 
       FIG. 59  shows cartridge  16  and vial puck  26  aligned for coupling. As shown in  FIG. 60 , bellows  16000  of each of the dry disconnect valves compresses on insertion and seals against the face of puck  26  to allow a conduit  16002  of each of the dry disconnect valves to be exposed to create the desired fluid and/or vent pathways between vial  18  and cartridge  16  (e.g., via pathways  15402  and  15404  of the cannula).  FIG. 61  shows a side view of a portion of cartridge  16  in which bellows  16000  protect and surround the conduits of each dry disconnect valve. As shown in the side views of puck  26  in  FIGS. 62 and 63 , in the example of  FIGS. 51-63 , puck  26  may be provided with an ambient air filter  16200  that filters incoming ambient air and a check valve  16204  that ensures that waste air cannot escape the system. 
     As described above in connection with, for example,  FIG. 29A , cartridge  16  may be provided with one or more diluent ports  3100 D 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  3100  to couple the diluent or waste container to cartridge  16 . However, in some implementations, ports  3100  and the associated magazines can be implemented with a dry disconnecting interface that does not include a needle.  FIGS. 64-68  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  42  or  44  to cartridge  16 . 
     The dry disconnecting interface of  FIGS. 64-68  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. 64  shows a male portion  16402  and a female portion  16400  of a dry disconnect shuttle valve. For example, male portion  16402  may be connected to a diluent container via tubing and female portion  16400  may be an implementation of one of diluent ports  3100 D of cartridge  16 . 
       FIG. 65  shows male side  16402  and female side  16400  in cross section, spaced apart by a gap  16500  and disconnected.  FIG. 66  shows male side  16402  and female side  16400  in cross section, in contact at interface  16600 , with the fluid path between male side  16402  and female side  16400  still closed.  FIG. 67  shows male side  16402  and female side  16400  in cross section, connected with shuttle valve  16702  of male side  16402  extended into female side  16400  such that a side port  16704  provides a fluid path  16700  from male side  16402  to female side  16400 .  FIG. 68  shows a broader view of male side  16402  and female side  16400  in cross section with the fluid path closed. 
     In some implementations of compounder  10 , one or more filters may be provided in the fluid flow path between cartridge  16  and receiving container  32  (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  16  and receiving container  32  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.  FIGS. 69 and 70  show exemplary implementations of a connector (e.g., a Texium® connector) for coupling to receiving container input  34  in which a filter  16900  is provided at the interface between the connector and tubing for coupled to cartridge  16 . In the example of  FIG. 69 , the connector is shown in partial transparency so that filter  16900  within the connector is visible. In the example of  FIG. 70 , a separate filter/screen element  17000  is disposed between the connector and the tubing. 
     Although various implementations of cartridge  16  have been described in which an oscillating piston pump (see, e.g., piston  166  of  FIG. 21 ) is operated to move fluid and/or gasses through cartridge  16  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. 71  shows an exemplary implementation of a syringe piston  17103  and an associated grasping mechanism  17101  (e.g., for grasping and actuating the syringe piston). In the example of  FIG. 71 , syringe piston  17103  includes a tapered grab handle  17102  and one or more seals such as o-rings  17100 . O-rings  17100  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  17100  can therefore be particularly helpful in micro-dosing scenarios. 
     Grasping mechanism  17101  may be a claw with arms that can be actuated to grasp grasping handle  17102 . Grasping mechanism  17101  may be actuatable to slowly move syringe piston  17103  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  17103 , as shown in  FIG. 71 , grasping mechanism  17101  may include tapered surfaces  17200  that are complementary to the tapered shape of grasping handle  17102 . Providing a tapered claw  17101  may reduce or eliminate backlash when mating grasping mechanism  17101  and tapered grasping handle  17102  of syringe plunger  17103  (e.g., by reducing or eliminating clearances between mating parts). For example, the tapered end  17102  of syringe plunger  17103  may be slid into the tapered groove of a syringe activation device such as claw  17101 . Syringe plunger  17103  may be securely held by approximately 180 degrees of contact by the syringe activation device. 
     The claw portion of grasping mechanism  17101  may be spring loaded or mechanically actuated. In other implementations, grasping mechanism  17101  may be a claw having a pitchfork design without moving parts. 
     The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. 
     The subject technology is illustrated, for example, according to various aspects described above. Various examples of these aspects are described as numbered concepts or clauses (1, 2, 3, etc.) for convenience. These concepts or clauses are provided as examples and do not limit the subject technology. It is noted that any of the dependent concepts may be combined in any combination with each other or one or more other independent concepts, to form an independent concept. The following is a non-limiting summary of some concepts presented herein: 
     Concept 1. A compounder system, comprising: 
     a cartridge having:
         a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port,   a pump component actuable 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; and   a bellows configured to surround the needle in an extended configuration and to be compressed to allow the needle to extend from the bellows into the vial.
 
Concept 2. The compounder system of Concept 1 or any other Concept, wherein the bellows forms a cavity around the needle and is configured to generate a vacuum pressure within the cavity when the bellows extends upon retraction of the needle from the vial.
 
Concept 3. The compounder system of Concept 2 or any other Concept, wherein the cartridge further comprises a spring configured to bias the bellows in the extended configuration.
 
Concept 4. The compounder system of Concept 3 or any other Concept, wherein the bellows comprises a dry disconnect seal.
 
Concept 5. The compounder system of Concept 4 or any other Concept, wherein the dry disconnect seal forms a distalmost boundary of the cavity, and wherein the needle is entirely disposed within the cavity when the bellows in in the extended configuration.
 
Concept 6. The compounder system of Concept 5 or any other Concept, wherein a portion of the needle extends through the dry disconnect seal when the bellows is in a compressed configuration.
 
Concept 7. The compounder system of Concept 6 or any other Concept, wherein the dry disconnect seal is configured to sealingly slide along an outer surface of the needle as the bellows is compressed from the extended configuration to the compressed configuration and when the bellows extends from the compressed configuration to the extended configuration.
 
Concept 8. The compounder system of Concept 3 or any other Concept, wherein the spring is a coil spring that wraps around at least a portion of the needle within the cavity.
 
Concept 9. A compounder system, comprising:
       

     a cartridge having:
         a plurality of controllable fluid pathways fluidly coupled to at least one diluent port and a receiving container port,   a pump member actuable 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, wherein the needle comprises a dual-lumen plastic needle.
 
Concept 10. The compounder system of Concept 9 or any other Concept, wherein the dual-lumen plastic needle comprises:
       

     a fluid pathway having upper and lower fluid ports; 
     a gas pathway having upper and lower gas ports; and 
     a tip, wherein the lower fluid port and the lower gas port are located away from the tip. 
     Concept 11. The compounder system of Concept 10 or any other Concept, wherein the dual-lumen plastic needle further comprises a vertical divider between the fluid pathway and the gas pathway, wherein the lower fluid port and the lower gas port are horizontally spaced apart, and wherein the lower fluid port is larger than the lower gas port.
 
Concept 12. The compounder system of Concept 11 or any other Concept, wherein the vertical divider extends along a length of the needle from a base of the needle to the tip.
 
Concept 13. The compounder system of Concept 12 or any other Concept, wherein the dual-lumen plastic needle further comprises an interior ledge configured to guide the vertical divider for assembly of the dual-lumen plastic needle.
 
Concept 14. The compounder system of Concept 9 or any other Concept, wherein cartridge comprises a body within which the plurality of controllable fluid pathways and the pump member are disposed, and wherein the dual-lumen plastic needle extends from an outer surface of the body of the cartridge.
 
Concept 15. The compounder system of Concept 9 or any other Concept, wherein the cartridge further comprises a compressible vacuum bellows configured to surround at least a portion of the needle.
 
Concept 16. A method, comprising:
 
     coupling a cartridge to a pump head of a compounder system, the cartridge having a body enclosing a plurality of fluid pathways, a needle extending from the body and having a lumen fluidly coupled to at least one of the fluid pathways, and a bellows forming a cavity within which the needle is disposed; and 
     extending the needle into a vial by compressing the bellows with the vial. 
     Concept 17. The method of Concept 16 or any other Concept, wherein extending the needle into the vial by compressing the bellows with the vial comprises moving the vial toward the cartridge such that a tip of the needle extends through a dry disconnect seal of the bellows.
 
Concept 18. The method of Concept 17 or any other Concept, wherein moving the vial comprises actuating a vial lift of the compounder system to remove the vial from a vial tray and to compress the bellows by pressing a vial puck attached to the vial against the bellows.
 
Concept 19. The method of Concept 16 or any other Concept, further comprising extending the bellows while removing the needle from the vial such that extension of the bellows generates a vacuum within the bellows.
 
Concept 20. The method of Concept 19 or any other Concept, wherein extending the bellows comprises sealingly sliding a dry disconnect seal of the bellows along an outer surface of the needle.
 
     One or more aspects or features of the subject matter described herein may be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. For example, infusion pump systems disclosed herein may include an electronic system with one or more processors embedded therein or coupled thereto. Such an electronic system may include various types of computer readable media and interfaces for various other types of computer readable media. Electronic system may include a bus, processing unit(s), a system memory, a read-only memory (ROM), a permanent storage device, an input device interface, an output device interface, and a network interface, for example. 
     Bus may collectively represent all system, peripheral, and chipset buses that communicatively connect the numerous internal devices of electronic system of an infusion pump system. For instance, bus may communicatively connect processing unit(s) with ROM, system memory, and permanent storage device. From these various memory units, processing unit(s) may retrieve instructions to execute and data to process in order to execute various processes. The processing unit(s) can be a single processor or a multi-core processor in different implementations. 
     A reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention. 
     The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent. 
     As used herein, the phrase “at least one of” preceding a series of items, with the term “or” to separate any of the items, modifies the list as a whole, rather than each item of the list. The phrase “at least one of” does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrase “at least one of A, B, or C” may refer to: only A, only B, or only C; or any combination of A, B, and C. 
     A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa. 
     In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. 
     It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method Concepts present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented. 
     All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the Concepts. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the Concepts. No Concepts element is to be construed under the provisions of 35 U.S.C. § 112 (f) unless the element is expressly recited using the phrase “means for” or, in the case of a method Concepts, the element is recited using the phrase “step for.” Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a Concepts. 
     The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the Concepts. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each Concepts. Rather, as the following Concepts reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following Concepts are hereby incorporated into the Detailed Description, with each Concept standing on its own as a separately disclosed subject matter. 
     The Concepts are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language Concepts and to encompass all legal equivalents. Notwithstanding, none of the Concepts are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.