Syringe pumps for automated compounding machines

Abstract

Various aspects of the present disclosure relate to a compounding machine system having a cassette with controllable fluid pathways. The cassette may include a syringe pump for moving fluids and / or gases, and one or more syringe valves or rotary valves for controlling which of the controllable fluid pathways is opened for fluid and / or gas flow.

Description

[0001] This application is a divisional application of the invention application with application date of March 23, 2018, application number 201880033674.8, and name “Syringe pump for automatic drug compounding machine”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 476,683, filed on March 24, 2017, entitled “Automatic Drug Compounder,” the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0004] The present disclosure generally relates to apparatus for reconstituting, mixing and delivering medications from vials to receiving containers. In particular, the present disclosure relates to pump and valve features of closed system automated medication compounding machines. Background Art

[0005] Drug compounding is the practice of creating specific drug products to meet the unique needs of patients. In practice, compounding is usually performed by pharmacists, technicians or nurses who use various tools to combine appropriate ingredients. A common form of compounding includes the combination of powdered drug preparations with specific diluents to create suspended drug compositions. These types of compositions are commonly used for intravenous / parenteral drugs. Crucially, drugs and diluents must be kept in a sterile state during the compounding process, and there is a demand to automate the process while maintaining appropriate mixing characteristics (i.e., certain drugs must be stirred in a specific way so that the drug is properly mixed into the solution, but the solution does not foam and does not produce air bubbles). There is a demand for a compounding system that is easy to use, can be used frequently and efficiently, is reliable, and reduces user errors. Summary of the invention

[0006] The compounder system can pump diluent from the diluent container to the vial containing the medication, and then pump the reconstituted medication to the receiving container. To ensure that each medication is properly and safely reconstituted and moved to the receiving container without mixing or leaking of the medication, a disposable cassette is provided that couples the diluent container and the receiving container to the vial and includes fluid pathways controllable by valves of the cassette for pumping fluid to and from the vial and container.

[0007] The pump component of the cassette is actuatable to move the fluid and control the movement of the fluid through the controllable fluid passage. In some examples, the pump component may include a syringe pump and a rotary valve assembly or a syringe pump and a syringe valve assembly.

[0008] According to various aspects of the present disclosure, a compounder system is provided, comprising: a tablet box having a plurality of controllable fluid pathways fluidly connected to at least one diluent port, a waste port, and a receiving container port; and a syringe pump / syringe valve device having a plurality of syringes operable to control the movement of one or more fluids through the plurality of controllable fluid pathways.

[0009] According to other aspects of the present disclosure, a compounding machine system is provided, comprising: a tablet box having a plurality of controllable fluid pathways, which are fluidically connected to at least one diluent port, a waste port and a receiving container port; and a syringe pump / rotary valve device having a syringe and a plurality of rotary valves, which are operable to control the movement of one or more fluids through the plurality of controllable fluid pathways.

[0010] According to other aspects of the present disclosure, a compounder system is provided, which includes a tablet box having: a plurality of controllable fluid passages; a syringe pump; and a plurality of valves operable to selectively connect the syringe pump to one or more of the plurality of controllable fluid passages. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings (which are included to provide further understanding and are incorporated in and constitute a part of this specification) illustrate the disclosed embodiments and together with the description serve to explain the principles of the disclosed embodiments. In the drawings:

[0012] Figure 1 A front perspective view of an example of an exemplary embodiment of a compounding system according to aspects of the present disclosure is shown.

[0013] Figure 2 A device with a transparent housing according to some aspects of the present disclosure is shown. Figure 1 Front perspective view of the compounding system.

[0014] Figure 3 shows a schematic diagram of a device according to some aspects of the present disclosure with the housing removed. Figure 1 Side view of the compounding system.

[0015] Figure 4 A perspective view of an exemplary embodiment of a pump drive mechanism according to aspects of the present disclosure is shown.

[0016] Figure 5 According to some aspects of the present disclosure Figure 4 Exploded view of the pump drive mechanism.

[0017] Figure 6 A perspective view of an exemplary embodiment of a pump head assembly with a clamping system and a vial disc is shown, according to aspects of the present disclosure.

[0018] Figure 7 According to some aspects of the present disclosure Figure 6 Perspective view of the pump head assembly, clamping system, and vial disc.

[0019] Figure 8 is a flow chart illustrating an exemplary embodiment of steps of a process according to some aspects of the present disclosure.

[0020] Fig. 9 A perspective view of an exemplary embodiment of a cassette is shown according to aspects of the present disclosure.

[0021] Fig.10 A perspective view of an exemplary embodiment of a turntable with a cover according to aspects of the present disclosure is shown.

[0022] Fig.11 A front perspective view of another exemplary embodiment of a compounding system according to aspects of the present disclosure is shown.

[0023] Fig.12 shows a housing with some parts removed according to some aspects of the present disclosure Fig.11 Front perspective view of the compounding system.

[0024] Fig.13 shows a housing with some parts removed according to some aspects of the present disclosure Fig.11 Rear perspective view of the compounding system.

[0025] Fig.14 FIG. 1 shows an exemplary embodiment of a device according to some aspects of the present disclosure, with various components shown in an enlarged view for clarity. Fig.11 A perspective view of the compounding system.

[0026] Fig.15 According to some aspects of the present disclosure Fig. 9 A perspective view of a film cassette.

[0027] Fig.16 A device with a transparent baffle according to some aspects of the present disclosure is shown. Fig. 9 A perspective view of a film cassette.

[0028] Fig.17 A perspective view of an exemplary embodiment of a cassette with a backpack attachment according to aspects of the present disclosure is shown.

[0029] Fig.18 A device with a transparent backpack attachment according to some aspects of the present disclosure is shown. Fig.17 A perspective view of a film cassette.

[0030] Fig.19An exploded perspective view of another embodiment of a pump cassette according to aspects of the present disclosure is shown.

[0031] Fig. 20A According to some aspects of the present disclosure Fig.19 Rear plan view of the film box.

[0032] Fig. 20B According to some aspects of the present disclosure Fig.19 Front plan view of the film box.

[0033] Fig.21 A device with an attached backpack according to some aspects of the present disclosure is shown. Fig.19 A cutaway perspective view of a film box.

[0034] Fig. 22 According to some aspects of the present disclosure Fig.19 A sectional side view of a film box.

[0035] Fig.23 A diagram showing valves and fluid flow paths according to some aspects of the present disclosure is shown. Fig.19 Film box.

[0036] Fig.24 A valve configuration showing a fluid path for diluent to a receiving container is shown according to some aspects of the present disclosure. Fig.19 Film box.

[0037] Fig.25 A diagram showing a valve configuration for reconstructing a fluid path therethrough according to some aspects of the present disclosure is shown. Fig.19 Film box.

[0038] Fig.26 A valve configuration showing a recombinant fluid path from a Fig.19 Film box.

[0039] Fig. 27 A diagram showing a valve configuration for an air removal fluid path according to some aspects of the present disclosure is shown. Fig.19 Film box.

[0040] Fig.28 is a diagram showing the positioning of certain valves according to some aspects of the present disclosure.

[0041] Fig.29A A diagram showing a plurality of ports according to some aspects of the present disclosure is shown. Fig.19 A sectional side view of a film box.

[0042] Fig.29B It shows that some aspects of the present disclosure can be used with Fig.29AA cross-sectional side view of a portion of a diluent manifold with a needle engaged to one of the ports.

[0043] Fig.29C A diagram showing a port seal formed from a plurality of sealing members according to some aspects of the present disclosure is shown. Fig.19 A cross-sectional side view of a portion of a cassette.

[0044] Fig.29D shows a compression according to some aspects of the present disclosure Fig.29C FIG29B is a cross-sectional side view of a portion of a manifold of a portion of a cassette.

[0045] Fig.30 A cut-away perspective view of a cassette positioned adjacent a vial is shown in accordance with aspects of the present disclosure.

[0046] Fig.31 A schematic diagram of a device in the vicinity of a double lumen needle according to some aspects of the present disclosure is shown. Fig.19 A cross-sectional side view of a portion of a cassette.

[0047] Fig.32 A partial cross-sectional view of a rotary piston pump / valve according to some aspects of the present disclosure is shown.

[0048] Fig.33 FIG. 1 shows a flow chart of a flow chart of a flow chart during a transition between an introduction stroke and an ejection stroke according to some aspects of the present disclosure. Fig.32 Partial cross-sectional view of a rotary piston pump / valve.

[0049] Fig.34 According to some aspects of the present disclosure Fig.32 A partial cross-sectional view of a rotary piston pump / valve during the discharge stroke.

[0050] Fig.35 Shown is a front view of a compounding cassette with a rotary piston pump / valve according to aspects of the present disclosure.

[0051] Fig.36 A perspective view of a syringe pump / syringe valve apparatus according to some aspects of the present disclosure is shown.

[0052] Fig.37 A perspective view of the housing of a syringe pump / syringe valve device is shown according to some aspects of the present disclosure.

[0053] Fig.38 A perspective view of a housing and base plate for a syringe pump / syringe valve device is shown, according to some aspects of the present disclosure.

[0054] Fig.39 and 40The configuration of a syringe pump / syringe valve apparatus during a reconstitution operation is shown according to aspects of the present disclosure.

[0055] Fig.41 and 42 The configuration of a syringe pump / syringe valve apparatus during a compounding operation according to some aspects of the present disclosure is shown.

[0056] Fig.43 and 44 The configuration of a syringe pump / syringe valve apparatus during an air purge operation is shown in accordance with aspects of the present disclosure.

[0057] Fig.45 and 46 The configuration of a syringe pump / syringe valve apparatus during waste gas removal operation according to some aspects of the present disclosure is shown.

[0058] Fig.47 A syringe pump / syringe valve apparatus is shown attached to a compounding cassette in accordance with aspects of the present disclosure.

[0059] Fig.48 A perspective view of a syringe pump / rotary valve apparatus according to some aspects of the present disclosure is shown.

[0060] Fig.49 Another perspective view of a syringe pump / rotary valve apparatus is shown in accordance with aspects of the present disclosure.

[0061] Fig.50 Another perspective view of a syringe pump / rotary valve apparatus is shown in accordance with aspects of the present disclosure.

[0062] Fig.51 A syringe pump / rotary valve apparatus is shown attached to a compounding cassette in accordance with aspects of the present disclosure.

[0063] Fig.52 A perspective view of a rotary valve of a syringe pump / rotary valve apparatus is shown in accordance with aspects of the present disclosure.

[0064] Fig.53 A perspective view of a pump head assembly having magnets for attaching a compounding cassette thereto is shown, according to some aspects of the present disclosure. DETAILED DESCRIPTION

[0065] The detailed description given below describes various configurations of the present technology and is not intended to represent the only configuration in which the present technology can be implemented. In order to provide a thorough understanding of the present technology, the detailed description includes specific details. Accordingly, as a non-limiting example, dimensions may be provided with respect to certain aspects. However, it will be apparent to those skilled in the art that the present technology may be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concept of the present technology.

[0066] It should be understood that the present disclosure includes examples of the present technology and does not limit the scope of the appended claims. Various aspects of the present technology will now be disclosed based on specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations and according to the desired application or implementation.

[0067] The present system includes a number of features and techniques that together form a compounding system that can effectively reconstitute a medication in a sterile environment and deliver the compounded medication to a delivery bag for use with a patient.

[0068] Figure 1 A compounder system 10 according to one embodiment is shown. Figure 2 The system 10 is shown having a transparent outer housing 12, while Figure 3 Shown is a system in the case where housing is removed. The system comprises a turntable assembly 14, which comprises up to 10 independent sheet boxes 16. If necessary, turntable 14 can keep more or less sheet boxes 16. Sheet box 16 is disposable, and provides a unique fluid path between a vial 18, a plurality of diluents and the receiving container that comprises powder medicament (or concentrated liquid medicament). If necessary, sheet box 16 can also provide a fluid path leading to a vapor waste container. However, in other embodiments, filtered or unfiltered non-toxic waste can be discharged to the environment from the compounding machine, thereby reducing or eliminating the demand to the waste port. Each sheet box comprises a piston pump and a valve, which moves through the sheet box and enters the receiving container along with fluid and controls the introduction, discharge and fluid path selection of fluid during the step of the compounding process.

[0069] The turntable assembly 14 is mounted on the equipment so that it can rotate so that different cassettes 16 are aligned with the pump drive mechanism 20. The turntable 14 is usually encapsulated in the housing 12, and the housing 12 can be opened so as to replace the turntable 14 with a new turntable 14 after removing the used turntable. As shown in the figure, the turntable 14 can accommodate up to 10 cassettes 16, thereby allowing a specific turntable to be used up to 10 times. In this structure, each turntable assembly can support, for example, 10 to 100 receiving containers, depending on the type of compounding to be performed. For example, for dangerous drug compounding, the turntable assembly can support compounding to ten receiving containers. In another example, for non-dangerous drug compounding such as antibiotics or analgesic drug compounding, the turntable assembly can support compounding to 100 receiving containers. The housing 12 also includes a star wheel 22 positioned below the turntable 14. The star wheel 22 rotates the vial 18 of the medicine to a position consistent with or separated from the specific cassette 16 on the turntable 14. The housing 12 may also include an opening 24 for loading the vials 18 into position on the star wheel 22 .

[0070] Each of the cassettes 16 in the carousel 14 is a disposable unit that includes multiple passages for diluent and vapor waste. These passages will refer to, for example, Fig.39 Etc. are described in detail.Each cassette 16 is a small single disposable unit, which can also include a "backpack", wherein the tube for being connected to a receiving container (for example, IV bag, syringe or elastic bag) can be kept.Each cassette 16 can also include a pumping mechanism (such as a piston pump for moving fluid and steam through cassette 16) and a double-chamber needle in the housing, once bottle 18 has been moved into place by pump drive mechanism 20, the double-chamber needle can puncture the vial disk 26 on the bottle 18.For example, the needle can puncture the vial disk 26 via the compression of the vial disk 26 moving toward the needle.Each cassette 16 also includes a plurality of ports designed to match the needle of a plurality of diluent manifolds.Each cassette 16 also includes the opening of the locking clamp and the mounting post to receive the locking clamp from pump head assembly 28.Although described as an example herein is the locking clamp, other locking mechanisms can also be used to take out and lock the cassette to the pump head (for example, a clamp, a forceps or the like can extend from the pump head). Each cassette 16 also includes an opening that allows a valve actuator from the pump motor mechanism to interact with a valve on each cassette 16 .

[0071] Adjacent to the housing 12 that holds the vials 18 and the turntable 14 is a device 30 for holding at least one container 32, such as an IV bag 32 as shown. The IV bag 32 typically has two ports, such as ports 34 and 36. For example, in one embodiment, port 34 is an introduction port 34 and port 36 is an outlet port 36. Although this embodiment is sometimes discussed herein as an example, either of the ports 34 and 36 can be implemented as an input and / or outlet port for the container 32. For example, in another embodiment, an inlet 34 for receiving a connector at the end of a tube 38 can be provided on the outlet port 36. In the illustrated embodiment, the IV bag 32 is suspended from the holding device 30, which in one embodiment is as shown in FIG. Figure 1-3 As discussed in further detail below, 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, which detects and monitors the weight of the hung container. The holding device 30 may be in any other form required to position the IV bag 32 or other drug container. Once the IV bag 32 is positioned on the holding device 30, the first tube 38 (a portion of which is in the Figure 1 1 (shown in FIG. 1 ) is connected from the cassette 16 on the carousel 14 to the inlet 34 of the IV bag 32. For example, the first tube can be contained in a backpack attached to the cassette and extended from within the backpack (e.g., by an operator or automatically) to reach the IV bag 32. A connector such as a A connector 37 such as a connector is used to connect to the inlet 34 of the receiving container 32 .

[0072] On the opposite side of compounding machine 10 is a holding device 40 for holding an array of multiple IV bags 32 or other containers. In the illustrated version of compounding machine 10, five IV bags 42, 44 are shown. Three of these bags 42 can contain diluents, such as saline, D5W or sterile water, but any diluent known in the art can be adopted. The additional bag in this array can be an empty vapor waste bag 44, which is used to collect waste, such as the potential danger or toxic vapor waste from the mixing process. The additional bag 44 can be a liquid waste bag. The liquid waste bag can be configured to receive non-toxic liquid waste such as saline from a receiving container. As discussed in more detail below, a mechanical pump can be used to pump liquid waste to the waste bag via a dedicated pipe. In operation, the diluent line and the vapor waste line from corresponding containers 42 and 44 can be connected to the cassette 16 by a disposable manifold respectively.

[0073] The compounding system 10 also includes a specialized vial disk 26 that is designed to attach to multiple types of vials 18. In operation, the vial disk 26 is placed over the vials 18 containing the medication that needs to be reconstituted. Once the vial disk 26 is in place, the vials 18 are loaded into the star wheel 22 of the compounding machine 10. While the vial disk 26 is in the star wheel 22 and when the vial disk 26 is subsequently rotated into place, mating features on the vial disk 26 provide proper alignment so that the compounding machine 10 can remove it from the star wheel 22 for further processing.

[0074] According to one embodiment, the pump drive mechanism 20 is Figure 4 is shown in Figure 5 is shown in exploded view. Figure 4 and 5 In the embodiment shown in , the pump drive mechanism 20 includes multiple sections. At one end of the pump drive mechanism 20 is a rotating housing 46, which holds the drive electronics and includes a locking flange 94 on its housing 96 for a flexible tube 50, which can extend from one or more diluent containers and / or waste containers to one or more corresponding manifolds. The rotating housing 46 can rotate about its axis to rotate the rest of the pump drive mechanism 20. The rotating housing 46 includes bearing ribs 52 on its ends that allow it to rotate. For example, the pump drive mechanism can be configured to rotate any suitable angle, such as up to and including 180°, or greater than 180°.

[0075] The compounding machine system also includes a diluent cassette that is mounted in a slot 60 located on the side of the pump drive mechanism. The diluent cassette can be a disposable piece that is configured to receive any number of individual diluent manifolds that can operate as diluent ports. The diluent manifolds can be modular so that they can be easily and removably connected to each other, the cassette, and / or to the pump drive mechanism 20.

[0076] The pump drive mechanism 20 also includes a pump head assembly 28. The pump head assembly 28 includes a vial grab arm 76, a vial lifter 78, a pump cassette grab 80, a pump piston eccentric drive shaft 82 with a drive pin 222, a valve actuation mechanism 84, and a motor that allows the pump drive mechanism 20 to move forward and backward and rotate to mix the drug in the vial 18 after the diluent has been added to the vial. The compounding machine 10 may also include an input screen 86, such as a touch screen 86 shown in the figure, to provide data input by the user and to provide notifications, instructions and feedback to the user.

[0077] According to one embodiment, now Figure 8The operation of the compounder system 10 is generally described in the flowchart shown. In a first step 88, the user inserts a new diluent manifold cassette having multiple manifolds (e.g., a diluent manifold and a waste manifold) into the slot 60 on the side of the pump head assembly 28. The manifolds can be loaded into the cassette before or after the cassette is installed into the slot 60. The manifold holds the needles within the housing of the manifold until the cassette 16 is subsequently locked in place. The cassette can contain any number of diluent manifolds and vapor waste manifolds. In an illustrative system, there can be three diluent manifolds and one vapor waste manifold. In the next step 92, the diluent tubes are connected to the corresponding diluent bags. The tubes can 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 Fig.11 In the illustrated embodiment of the compounding machine, the tube is held in place by a locking flange 2402 on the frame of the compounding machine. Alternatively, other types of clamps or locking mechanisms known in the art may be used to securely hold the tube in place. Figure 4 In the illustrated embodiment of FIG. 1 , an additional flange 94 is provided, positioned on the outer housing 96 of the pump drive mechanism 20, for securing the internal wiring of the compounding machine. In the next step 98, the waste tube can be connected to the vapor waste bag 44. In other embodiments, the tubes can be pre-connected between the manifold and the associated containers (such as the diluent container and / or the waste container), and the operations of steps 92 and 98 can be omitted.

[0078] If necessary, in the next step 100, a new turntable 14 can be loaded into a turntable mounting station such as a turntable hub of a compounding machine system. The turntable 14 can include any number of disposable cassettes 16 configured in a generally circular array. In the next step 110, a vial disc 26 is attached to the top of a vial 18 of a powder or liquid drug for reconstitution, and in the next step 112, the vial 18 is loaded into a star wheel 22 below the turntable 14. Step 110 can include loading a plurality of vials 18 into a plurality of vial disc recesses in the star wheel 22. After one or more vials are loaded into the star wheel, the vials are rotated into place to allow and start scanning of the vial labels of each vial. In one embodiment, the user will be allowed to load the vial into the star wheel until all vial slots are occupied by vials before starting the scan. A sensor can be provided that detects the loading of each vial and then rotates the next vial disc recess to a loading position for the user. Allowing the user to load all vials into the star wheel before scanning the vial labels helps improve the efficiency of compounding. However, in other embodiments, the scanning of the vial labels can be performed after each vial is loaded or after a subgroup of vials is loaded. After these setup steps, the next step 114 is for the user to select the appropriate dose on the input screen.

[0079] After selecting on the input screen 86, the compounding machine 10 begins operation 116. The star wheel 22 rotates the vial to align 118 with the vial grabbing caliper 76 of the pump head assembly 28. The vial disk 26 includes, for example, a gear that engages with a gear coupled to a rotary motor, which allows the vial 18 to rotate 120 so that a scanner (e.g., a barcode scanner or one or more cameras) can scan 122 the label on the vial 18. The scanner or camera (and associated processing circuitry) can determine the batch number and expiration date of the vial. The batch number and expiration date can be compared with other information (such as the current date and / or a recall or other instruction associated with the batch number). Once the vial 18 is scanned and aligned, in the next step 124, the pump drive mechanism 20 moves forward into position to clamp the vial 18 with the caliper 76. The forward movement also aligns the mounting posts 130 and locking clips 128 on the front of the pump head assembly 28 with the corresponding openings on the cassette 16. In the next step 126, the cassette 16 is locked in place on the pump head assembly 28 by the locking catch 128, and the caliper 76 clamps 132 the vial disk 26 on top of the vial 18. The caliper 76 then removes 132 the vial 18 from the star wheel 22 by moving backward, while pulling 134 the cassette 16 off the turntable 14.

[0080] In some embodiments, the cassette 16 includes a backpack, which includes a coiled tube. In this embodiment, in step 136, the pump drive mechanism 20 tilts the cassette 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, after the cassette 16 is pulled away from the rotating disk 14, the tube 38 is exposed to the side of the rotating disk 14. In another alternative embodiment, the tube 38 is automatically pushed out (e.g., emerges from the backpack), thereby allowing the user to catch the connector at the end of the tube and be connected to the receiving container. The system prompts 138 users to pull out the tube from the rotating disk 14 and connect it to the input port 34 of the IV bag 32. Once the tube 38 is connected, in step 140, the user can notify the compounding machine 10 to continue the compounding process by interacting with the input screen 86.

[0081] At step 142, the vial 18 is pulled toward the cassette 16 so that one or more needles of the cassette 16, such as a coaxial dual-lumen needle, pierce the top of the vial disk 26 and enter the interior of the vial 18. Figure 8 The example of shows that the user attaches the tube from the cassette to the receiving container and the needle is engaged with the vial disk, but this is only illustrative. In another embodiment, steps 138 and 140 can be performed after step 142 so that the user attaches the tube from the cassette to the receiving container before the needle and the vial disk are engaged.

[0082] At step 144, the diluent is pumped into the vial 18 in an appropriate dosage through the cassette 16 and the first needle pump. If necessary, the second or third diluent can be added to the vial 18 via the second or third diluent manifold attached to the cassette 16. At the same time, the vapor waste is pumped 144 out of the vial 18 through the second needle pump, through the cassette 16 and the vapor waste manifold, and into the vapor waste bag 44. The valve actuator 84 on the pump head assembly 28 opens and closes the valve of the cassette 16 so that the fluid flow path is changed as needed during the process. Once the diluent is pumped into the vial 18, the pump drive mechanism 20 shakes the vial 18 in the next step 146 by rotating the vial lifter 78 up to, for example, 180 degrees, so that the vial 18 rotates between the front side facing up position and the inverted position. The shaking process can be repeated for the necessary time, depending on the type of the drug to be reconstructed. In addition, different shaking modes can be used according to the type of medicament to be reconstructed. For example, for some medicaments, instead of rotating 180 degrees, a combination of the front-back and left-right motions of the pump head can be performed to produce the gyratory shaking of the bottle. A plurality of default shaking modes for specific medicaments or other medical fluids can be included in the medicament information library stored in the compounding machine control circuit (and / or accessible by the compounding machine control circuit). Once the shaking step is completed, the pump drive mechanism rotates the bottle to an inverted position or other suitable position and keeps it in place. In certain embodiments, fluids such as the diluent pumps already in the receiving container 32 (for example, by a cassette or via a separate path) can be pumped into a liquid waste container to leave room in the receiving container to receive the reconstructed medicine.

[0083] In the next step 148, the valve actuator 84 reorients the valve of the cassette, and the pumping mechanism of the cassette 16 is enabled to pump 150 the reconstituted medicament through the attached tube into the receiving bag 32. Once the medicament is pumped into the receiving bag 32, in the next step 152, the pump drive mechanism 20 clears the tube 38 by 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 medicament is provided to the receiving bag 32. In some scenarios, a syringe may be used as the receiving container 32. In scenarios where a syringe is used as the receiving container 32, after delivering the reconstituted medicament to the syringe, a vacuum may be generated in the tube 38 by the pump drive mechanism 20 to remove any air or other vapor that may have been pushed into the syringe, so that when the syringe is removed from the tube 38, the reconstituted medicament is ready for delivery to the patient, and no air or other undesirable gas is present in the syringe.

[0084] The system then prompts 154 the user to remove the tube 38 from the receiving container 32. The user can then remove the connector (e.g. or The vial 18 is inserted into its slot in the backpack or carousel, and an optical sensor in the pump head can sense the presence of the connector and automatically retract the tube into the carousel or backpack. Depending on the type of system used, the tube is pulled back into the carousel 14 or backpack. In the next step 156, the compounding machine 10 rotates the vial 18 back into alignment with the star wheel 22 and releases it. The used cassette 16 can also be replaced on the carousel 14. When a sensor in the pump driver determines that the tube has been replaced in the cassette (e.g., by sensing the connector through a window of the cassette, such as The presence of a connector at the end of the tube in the cassette's backpack) can release the used cassette. The turntable 14 and / or star wheel 22 can then rotate 158 to a new, unused cassette 16 and / or a new, unused vial 18, and the above process can be repeated for a new medicament. In some cases (e.g., multiple reconstitutions of the same medicament), a single cassette can be used more than once with more than one vial.

[0085] The cassettes 16 are designed to be disposable, allowing the user to use all the cassettes 16 in a given turntable 14 before changing the turntable 14. After using a cassette 16, the turntable 14 rotates to the next cassette 16, and the system software is updated to indicate that the cassette 16 has been used, thereby preventing cross contamination from other reconstructed medicaments. Each cassette 16 is designed to contain all necessary flow paths, valves, filters and pumps to reconstruct medicaments with multiple diluents when necessary, pump reconstructed medicaments into a receiving container, pump vapor waste out of the system into a waste container, and perform the final QS step to ensure that the appropriate amount of medicament and diluent are present in the receiving container. This complete set is made possible by the specific and unique configuration of the cassette 16, its flow paths and its valve configuration.

[0086] One embodiment of the cassette 16 is Fig. 9 As shown in Fig. 9 As shown in FIG. 1 , the cassette 16 may include a cassette frame 160, a cassette baffle 164, and a piston pump 166, a needle housing 168, and a needle assembly 170. The cassette frame 160 provides primary support for each cassette 16 and includes a diluent chamber, a vapor waste chamber, a pump chamber, a hydrophobic drain, an outlet port, and / or other features that may be connected to a tube connected to the receiving container 32 as described below.

[0087] The frame 160 of the cartridge 16 also includes positioning 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 the mounting posts 130 from the pump head assembly 28; and keyholes 210 that allow the locking clip 128 to be inserted therein and rotated to lock the cartridge 16 to the pump head assembly 28 for removal from the turntable 14. In some embodiments, an outlet port extension 220 may be present. The piston pump 166 is mounted in a chamber, and the rod 194 is positioned in the silicone piston shield. Further, the baffle 164 includes an opening 228 in which the valve 190 of the sealing membrane is located and is touched by the valve actuator 84. In addition, the baffle 164 includes an opening 230 that allows the fluid manifold to be connected to the diluent chamber and vapor waste chamber in the cartridge 16. As discussed in more detail below, the shutter 164 may also include an opening that facilitates detection of the connector (e.g., or In operation, the needle of the fluid manifold enters through the opening 230 in the baffle 164 and punctures the sealing membrane to gain fluid access to the diluent chamber and vapor waste chamber defined between the sealing membrane and the cassette frame 160 in the cassette 16. Further details of various embodiments of the cassette 16 will be discussed below.

[0088] refer to Fig.10 , an exemplary embodiment of the turntable 14 removed from the compounding machine 10 is shown, according to one embodiment. Fig.10 The turntable 14 in the embodiment includes an array of ten cassettes 16, but it should be understood that there may be more or fewer cassettes 16 on the turntable 14, thereby leaving some of the recesses 500 of the turntable 14 empty, or the frame 510 of the turntable may be designed to have more or fewer cassette recesses 500. In some embodiments, the turntable 14 may also optionally include a cover 511 that prevents a user from directly accessing the tubes connected to each of the cassettes 16. In these embodiments, if access to the back of the cassette 16 is required, the cover 511 can be removed. Fig.10 In an example embodiment, a connector such as An attachment 548 is disposed adjacent to each cassette 16 , the attachment 548 being attached to the tube 38 extending from the extension 220 on each cassette 16 .

[0089] Figure 11-14 FIG. 1 shows a compounding machine 10 according to another embodiment. Fig.11As shown in , the holding device 40 can be implemented as an extension arm that provides support for the mounting device of each of the containers 42 and 44. The holding device 40 and the holding device 30 can each include one or more sensors, such as a weight sensor, which is configured to provide a weight measurement value for determining whether an appropriate amount of fluid has been added to or removed from the container, or to confirm that the fluid is being transferred to and / or from the appropriate container (e.g., the appropriate diluent is being dispensed). A scanner 2404 can be provided, by which each diluent container and / or receiving container can be scanned before and / or after being attached to the compounding machine 10. As shown in FIG. Fig.11 As shown in , in various embodiments, a turntable cover 2400 and a tube management structure 2402 may also be provided on the compounding machine 10. For example, the tubes connected between the containers 42 and / or 44 and the corresponding manifolds may each be installed in a groove of the tube management structure 2402 to prevent the tubes from getting tangled or hung during operation of the compounding machine 10.

[0090] An opening may be provided through which vials 18 may be mounted in the star wheel. Additionally, an external pump 2500 may be provided for pumping non-toxic liquid waste from, for example, the receiving container 32 to the waste container 44 (e.g., for rapidly pumping a desired amount of saline out of the receiving container 32 and without passing the liquid waste through the cassette and / or other parts of the compounding machine).

[0091] A fluid module 2504 may be provided that includes a number of container mounts that may be used to suspend diluent containers and waste containers, and may include sensor circuitry to sense when a container is suspended and / or sense the weight of the container. In this way, the operation of the compounding machine 10 may be monitored to ensure that the correct diluent container has been scanned and suspended in the correct location, and that waste is provided to the appropriate waste container in the expected amount.

[0092] like Fig.12 As shown in FIG. 2 , the pump 2500 and the display 86 can be mounted to a housing 2600. The pump driver 20 can be partially mounted within the housing 2600, and the pump head assembly 28 can extend from the housing to a position that allows the pump head assembly to be rotated (e.g., to flip or shake the vial). Fig.12 Also shown in the figure is the turntable 14, in which no cassette is mounted, so that the cassette mounting recess 500 can be seen.

[0093] The star wheel 22 (sometimes referred to herein as the vial tray) is Fig.122604 with several empty vial disc recesses 2604. The vial tray 22 can be rotated, and the actuated door 2608 can be opened to facilitate loading of vials 18 into the vial disc recesses 2604 in the vial tray 22. In some embodiments, the door 2608 can be closed before the vial tray 22 is rotated to ensure that the operator's fingers are not at risk of being injured by the rotating tray. However, this is merely illustrative. In other embodiments, a sensor such as sensor 2650 (e.g., a light curtain) can be provided to replace (or supplement) the door 2608 to sense the presence of an operator near the tray 22 and prevent the tray from rotating if an operator or any other obstacle is detected.

[0094] Similarly, a cover may be provided for the turntable 14 to prevent contamination of the cassettes 16 loaded therein and to prevent injury to an operator due to the rotation of the turntable. A cover sensor (not shown) may also be provided to detect the position of the cover (e.g., an open position or a closed position). If the cover sensor does not detect that the cover is in the closed position, the rotation of the turntable 14 may be prevented.

[0095] Each inserted vial 18 can be detected using a sensor such as sensor 2652 (e.g., a load cell or optical sensor) when it is placed in the vial disk recess 2604. When detected, the inserted vial can be moved to the scanning position by rotating the vial tray 22, and the inserted vial 18 can then be rotated within its position in the vial tray 22 using the vial rotation motor 2602 to allow the vial label to be scanned.

[0096] The reverse perspective view of the compounding machine 10 is shown in FIG. Fig.13 2600, wherein the scanning components can be seen. Specifically, the camera 2700 is mounted in an opening in the housing 2600 and is configured to view the vial 18 in a scanning position. The motor 2602 can rotate the vial 18 up to one or more full revolutions so that the camera 2700 can capture an image of the vial label. In some embodiments, an illumination device 2702 (e.g., a light emitting diode or other light source) can be provided that illuminates the vial 18 for imaging with the camera 2700.

[0097] like Fig.13 As shown in FIG. 2 , one or more gears 2704 coupled to the motor 2602 may be provided that mesh with corresponding gears on the vial disk 26 attached to the vial 18 at the scanning position. The vial tray 22 may be rotated so that the vial disk gears mesh with the rotating motor gears so that the vials 18 rotate when the motor 2602 is operated.

[0098] Fig.13Also shown is how a cassette 2706 containing one or more manifolds can be installed in a recess in a pump head assembly 28. The cassette slot for a vapor waste manifold in the cassette 2706 can be keyed to prevent the diluent manifold from accidentally connecting to the slot (or the waste manifold from accidentally connecting to the diluent slot in the cassette). The other diluent slots in the cassette 2706 can have a common geometry so that any diluent manifold can be assembled in the cassette diluent slot. One or more manifold sensors such as a manifold sensor 2750 (e.g., an optical sensor) can be disposed in a manifold recess in the pump head assembly 28. The manifold sensor 2750 can be configured to detect the presence (or absence) of a manifold in a manifold recess (slot) in the cassette 2706 to ensure that an appropriate manifold (e.g., a diluent manifold or a waste manifold) is loaded at an expected position for a compounding operation. In this way, the pump head can detect the presence of a manifold. The pump head and / or the manifold sensor can communicate with a diluent load sensor to ensure the proper positioning of the diluent manifold. Various operating components 2708 (such as valve actuators, needle actuators, mounting posts, locking clips and drive pins) can also be seen extending from the pump head assembly 28, which are configured to secure and operate the pump cartridge 16.

[0099] The compounding machine 10 may include additional components, such as a frame base and a frame housing, and internal electronic components. The pump driver 20 may be seated in an opening in the frame housing that allows the pump head assembly 28 to protrude from the frame housing. Processing circuits for managing operations of the compounding machine system 10 may be included in the electronic components.

[0100] The carousel 14 may be placed onto the carousel hub and rotated by a vial tray plus carousel drive assembly that operates to rotate the hub to move selected cassettes in the carousel into position for removal and manipulation by the pump drive 20. The vial tray plus carousel drive assembly may include separate drive assemblies for the vial tray and for the carousel so that the vial tray 22 and carousel 14 may be rotated independently.

[0101] Fig.14 Another perspective view of the compounding machine 10 according to one embodiment is shown, which highlights the location of various specific components (such as the turntable 14 with the cassettes 16 mounted therein, the cassettes 16 with the backpack 2900, the vial disk 26 for mounting the vials 18, and the pump head assembly 28 with the diluent cassette 2706 containing a plurality of manifolds 2906). Some further features of the compounding machine 10 will be described below in conjunction with Fig.15 etc. for description.

[0102] The cassette 16 is designed to be disposable, thereby allowing the user to use all the cassettes 16 in a given turntable 14 before changing the turntable 14. After using a cassette 16, the turntable 14 rotates to the next cassette 16, and the system software is updated to indicate that the cassette 16 has been used, thereby preventing cross contamination from other reconstructed medicaments. Each cassette 16 is designed to contain all necessary flow paths, valves, filters, pistons and pumps, to reconstruct medicaments with multiple diluents when necessary, pump the reconstructed medicaments into the receiving container, pump the vapor waste out of the system into the waste container, and perform the last QS step to ensure that there is an appropriate amount of medicament and diluent in the receiving container. The amount of the diluent pumped into the vial for reconstructing and the amount of the medicine pumped out of the vial to the receiving container are controlled by the volumetric piston pump in the cassette, which can be compared with the weight obtained by the weight scale (such as one or more diluent load elements and receiving container load elements) of the compounding machine for quality control. This complete package is made possible by the specific and unique configuration of cassette 16, its flow paths, and its valve configuration.

[0103] Various embodiments of the cassette 16 are Figure 15-20B In one embodiment, the fully constructed cassette 16 is Fig.15 and 16 In Fig.17 and 18 FIG. 1 shows a cassette 16 having a tube management structure implemented as a backpack for the cassette. According to one embodiment, an exploded version of the cassette 16 is shown in FIG. Fig.19 1 and shows three major parts of the cassette 16: the cassette frame 160, the cassette sealing membrane 162, the cassette baffle 164, and the piston pump 166, the needle housing 168 and the needle assembly 170. In one embodiment, the fully constructed cassette 16 is Fig. 20A and 20B Shown in. Fig.19 , 20A The various features of the 20B cassette are Figure 21-31 Shown in.

[0104] like Fig.15 , a front view of the cassette 16 is shown. The cassette frame 160 provides the primary support for each cassette 16. A piston pump 166 and a cassette needle housing 168 for holding a needle assembly 170 are provided, which can be operated during reconstitution and filling of the receiving container 32 to move liquid and waste vapor to and from the vial 18. Valves 190 are positioned relative to the various internal flow paths within the cassette 16 for diluent, vapor waste, filtered air, and reconstituted medicament, and are operable to modify and control the internal flow paths when necessary.

[0105] 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: three openings 198 to receive the mounting posts 130 from the pump head assembly 28; and key holes 210 that allow the locking clips 128 to be inserted therein and rotated to lock the cartridge 16 to the pump head assembly 28 for removal from the turntable 14.

[0106] The cassette needle housing 168 extends from the bottom of the cassette frame 160 and can be designed to be removable by snapping a pair of locking flanges 214 on the needle housing 168 into flange openings 216 in the cassette frame 160. The cassette needle housing 168 is designed to prevent accidental contact between the user and the needle assembly 170 and to retain one or more needles of the needle assembly (see, e.g., Fig.31 The needle housing 168 also receives the vial disk 26 in a certain position to allow the needle to pierce the vial disk 26.

[0107] A sealing membrane may be disposed between the frame 160 and the baffle 164 to cooperate with internal features of the frame 160 and the baffle 164 to form a sealed internal flow path in the cassette 16 , as described in more detail below.

[0108] Before describing the various fluid flow paths in the cartridge 16, reference will be made to Figure 3 , 4 , 6 and 7 describe the operation of the pumping and valve mechanisms.

[0109] Piston pumps such as piston pump 166 are used as positive displacement pumps, which have significant advantages over traditional peristaltic pump mechanisms. First, no matter the orientation or environmental conditions of the pump, it has the best rate accuracy and flow continuity. Secondly, it can push the excess amount of 50psi into the elastic pump. Piston pump 166 can be positioned in the silicone piston pump shield in the cassette 16. The pump mechanism is driven by the motor in the pump motor mechanism 20, which rotates the drive pin 222 and the eccentric drive shaft 82 on the pump head assembly 28, and the pump head assembly 28 controls the movement of piston 166 and valve actuator 84. In operation, the cassette 16 is placed on the cassette gripper 80 on the post 130 and is locked in place by the locking clip 128. This aligns the valve arranged in the opening 228 of the baffle 164 with the valve actuator 84, and the eccentric drive shaft 82 and the pin 222 align with the piston pump 166. The piston 166 is driven by an eccentric drive pin 222. The pin 222 is parallel to but offset from the axis of rotation of the drive shaft, which produces a sinusoidal motion that is converted into axial movement of the piston 166.

[0110] The valve actuator 84 is Figure 6 and 7, which shows the pump head assembly 28 removed from the rest of the pump motor mechanism 20. Each of the valves in the opening 228 has a corresponding valve actuator 84, which is controlled by a gear cam to move the valve actuator 84 axially 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 position of the valve so that they can extend through the opening 228 in the baffle 164 of the cassette 16 and contact the valve. The valve actuators 84 are software controlled so that they can automatically open and close the valves depending on which internal flow paths within the cassette 16 are to be opened and closed.

[0111] The valve actuator 84 is operated at different times in the pumping cycle depending on the desired fluid flow path. The filling portion of the piston 166 begins as the piston rod 194 moves, and the inlet valve opens and the outlet valve closes. The other valves will open and close depending on the desired fluid flow path. When the piston 166 is in the bottom dead center position, at the end of the filling portion of the cycle, the valve actuation changes to close the inlet and open the outlet valve. At this time, the delivery portion of the cycle begins and the piston 166 moves in the opposite direction. When the piston 166 reaches the top dead center position (which is the starting position), the delivery portion of the cycle ends. When the piston 166 reaches this position, a new cycle begins.

[0112] The movement of the eccentric drive shaft 82 can be in a clockwise direction when delivering fluid under normal conditions, and in a counterclockwise direction when withdrawing fluid. Depending on the desired flow path, the pump mechanism can be made to pump backward. The drive can be prevented from being inadvertently driven backward in either direction by the action of pressure up to 50 psi in the disposable line.

[0113] exist Fig.17 and 18 An alternative embodiment of the cassette 16 that employs a "backpack" to coil the flexible tube 38 is shown in FIG. The backpack 298 is attached to the back of the cassette frame 160, and one end of the flexible tube 38 is attached to the outlet port on the back of the cassette frame 16. The backpack 298 includes a housing 310 and may include a tube control mechanism defined in a chamber that can be rotated or otherwise operated to coil the flexible tube 38. At the end of the tube opposite the outlet port is a connector 300 (e.g., an ISO Luer connector, such as Attachment) that can be pulled out of the backpack 298 by the user and attached to the receiving bag 32. In some embodiments, the tube attached to the connector 300 can be automatically extended from within the backpack 298 to facilitate attachment by the user. After the bag 32 is filled, the tube control mechanism can pull the flexible tube 38 back into the backpack 298 and out of the way so that the next cassette 16 in the carousel 14 can be used. Once the ISO Luer is placed into the opening in the backpack, the retraction of the flexible tube can be automatic.

[0114] Now go to Fig.19 , an exploded perspective view of another embodiment of the cassette 16 shows the three main parts of the cassette 16: the cassette frame 160, the cassette sealing membrane 162, the cassette baffle 164, and the piston pump 166, the needle housing 168 and the needle assembly 170. Fig.19 In the example of , the cassette baffle 164 includes an additional opening 3022 to provide access to a pressure dome formed on the membrane 162 to allow sensing of pressure in the fluid path of the cassette 16. An in-line air sensor assembly 3000 is also provided and is configured to mate with an air in-line (AIL) sensor in a compounding machine.

[0115] To control the flow of gases (such as vapor waste and sterile air) within the cartridge, the cartridge 16 may be provided with a gas flow control structure, such as an air filter 3006 and one or more check valve discs 3004, which are mounted to the frame 160 together with the check valve cover 3002. The air filter 3006, the check valve disc 3004, and the check valve cover 3002 may operate in coordination to allow vapor waste to flow from the vial to the waste port in only one direction, and to allow sterile (filtered) air to flow into the cartridge in only one direction from the drain port adjacent the air filter to the vial. In this way, non-desired vapor waste may be prevented from flowing away from the pump cartridge and may instead be directed to a vapor waste container.

[0116] like Fig.19 As shown in FIG. 3 , the piston 166 can include a piston shroud 3007 that, for example, provides one or more movable seals (eg, two movable seals) for controlling the volume of the pump chamber when the piston 166 is actuated. Fig.19 Also shown are various structures for controlling another embodiment of the needle housing 168, wherein the needle assembly 170 includes a dual lumen needle having a first needle overmold 317A, a second needle overmold 317B, a needle spring 3014, and a needle membrane 3008. An opening 3020 in the baffle 164 can be provided that aligns with a corresponding opening 3021 in the frame 160 to allow viewing through the cassette 16 (e.g., by a sensor of the pump drive mechanism) into a backpack mounted to the cassette 16, as will be described in further detail below. A protrusion 3016 formed on the top side of the cassette frame 160 can be provided as a mounting structure for the backpack.

[0117] Fig. 20A and 20B The diagram is shown from the baffle side and the frame side. Fig.19 An assembled view of the cassette embodiment shown in FIG. 1 , in which the opening 3120 (by Fig.19 The openings 3020 and 3021 are formed to allow viewing completely through the cassette 16. Fig. 20AAs shown in FIG. 1 , in some embodiments, the cartridge 16 can include four diluent and waste ports 3100 and pressure domes 3101. For example, three of the ports 3100 can be configured as diluent ports, and one of the ports 3100 can be configured as a waste port. A pressure sensor in the pump head assembly 28 can determine the pressure within the fluid passage in the cartridge 16 by contacting the pressure dome 3101. Each of the ports 3100 can be formed by an opening in the baffle 164 and a chamber behind a portion of the membrane 162 located in the frame 160.

[0118] Fig.21 is a cutaway perspective side view of an assembled cassette 16 having a backpack 3202 (e.g., Fig.14 2900) to form a film box plus backpack assembly 3203. Fig.21 3202, with the rucksack latched to the film box 16 at the top side.The additional latch structure of the bottom side will be described in more detail below.Additional structure 3200 can be arranged between rucksack 3202 and the film box 16.Structure 3200 can be roughly flat, and can be shaped and positioned to film box plus rucksack assembly 3203 latched to rotating disk 14.For example, the projection 3206 extending from the top of rucksack 3202 can be actuable, to help the film box plus rucksack assembly to be installed in the rotating disk and removed from the rotating disk.For example, the ramp structure on the rotating disk can compress projection 3206 when the film box plus rucksack assembly 3203 is pushed into the rotating disk, until projection 3206 is upwardly engaged in the locking position so that the film box plus rucksack assembly is fixed in the rotating disk. To remove the cassette plus backpack assembly 3203 from the turntable for a compounding operation, the catch 128 extending into the opening 210 can be rotated to lower the protrusion 3206 to release the cassette plus backpack assembly from the turntable. Some further features of coupling the cassette plus backpack assembly 3203 to the turntable will be described below.

[0119] A tube (e.g., flexible tube 38) for fluidly coupling the cassette 16 to the receiving container 32 can be housed within the backpack 3202. For example, the tube can be connected to the output port 180 (e.g., the receiving container port, see e.g., Fig. 20B ) is connected to the cassette 16 at a point, coiled within the interior cavity of the backpack 3202, and extends through the opening 3210 so that an operator can pull on one end of the tube to extend the tube for connection to the receiving container. An additional opening 3204 may be provided in which a connector such as a connector that is connected to the end of the tube may be stored when the cassette plus backpack assembly is not in use. Connector. When instructed (e.g., by on-screen instructions on display 86), the operator can remove the connector from opening 3204, pull the tube out of backpack 3202, and connect the connector to the receiving container. For example, the processing circuit of the compounding machine system can use the display to provide instructions to: (a) remove the connector connected to the tube from the additional opening in the backpack, (b) pull the tube out of the backpack, and (c) connect the connector to the receiving container. In another embodiment, the extension of the flexible tube is automatic (e.g., the software determines the precise moment when the flexible tube should be extended, the pump head operates the spiral mechanism to extend the tube, and provides a signal to the user to pull the ISO Luer out of the backpack opening). The compounding machine 10 may include a sensor such as an optical sensor that determines whether the connector is present in the opening 3204 (e.g., by observing the connector through the opening 3120).

[0120] The compounding machine 10 can determine whether and when to release the cassette plus backpack assembly from the pump head assembly based on whether the connector is in the opening 3204. For example, after the compounding operation, the operator can be instructed to remove the connector from the receiving container and return the connector to the opening 3204. The backpack 3202 can include features and components for facilitating storage and removal of tubes from the internal cavity. When the connector is detected to be in the opening 3204, the pump drive mechanism 20 can operate one or more winding mechanisms in the backpack 3202 to pull the extended tube back into the backpack, and the snap-on can be rotated to lower the protrusion 3206 so that the cassette plus backpack assembly can be returned to the turntable.

[0121] Fig.21 Also shown is an enlarged view of a portion of the cassette 16, with the cross section taken through two of the valves 190 within the openings 228 in the baffle 164. As shown in the enlarged view, each valve 190 may be formed by a raised portion 6908 of the sealing membrane 162 that extends from a flat portion 6906 of the sealing membrane 162 into a corresponding opening 228 in the cassette baffle 164. Figure 19-21 In the example shown, the raised portion 6908 is a pyramidal dome formed in the opening 228. In a portion of the fluid path 6900 formed between the sealing membrane 162 and the frame 160 adjacent each valve 190, the frame 160 may include a rib 6902 that is spaced opposite to the raised portion 6908 of the sealing membrane for the valve. When the raised portion 6908 is in the raised position, fluid and / or vapor can flow through the rib 6902 through the open valve. In operation, the valve actuator 84 extending from the pump head assembly 28 and operable by the pump head assembly 28 can extend through the opening 228 to compress the raised portion 6908 against the rib 6902 to close the valve and prevent fluid from flowing therethrough.

[0122] Fig. 221 is a cross-sectional side view of a cassette showing piston pump 166. Fig. 22 As shown in , the piston pump 166 may include a silicon shield 7100 having first and second seals 7102 and 7104. The front seal 7104 may form a moving boundary of a pump chamber 6106. The rear seal 7102 may prevent dust or other contaminants from contacting the front seal 7104. The pump chamber 7106 may be formed adjacent to one or more valves 190 (e.g., a pair of valves may be disposed on opposite sides of the pump chamber to control fluid flow in and out of the pump chamber).

[0123] exist Fig.23 , for the purpose of discussion herein, valve 190 is marked in three valve groups V1, V2 and V3. Valve group V1 can be a diluent valve group having three valves P1, P2 and P3. Valve group V2 can be a reconstruction valve group having three valves P1, P2 and P3. The piston pump valves P1 and P2 of valve group V3 (e.g., piston pump valve group) can be operated alternately in cooperation with piston pump 166. For example, during the forward stroke of piston pump 166, valve V3 / P1 can be closed and valve V3 / P2 can be opened, and during the backward stroke of piston pump 166, valve V3 / P1 can be opened and valve V3 / P2 can be closed to pump fluid in the fluid path of the cassette 16 in a first direction. In another example, to pump fluid in an opposite second direction within the fluid passage of the cartridge 16, during the forward stroke of the piston pump 166, valve V3 / P1 may be opened and valve V3 / P2 may be closed, and during the reverse stroke of the piston pump 166, valve V3 / P1 may be closed and valve V3 / P2 may be opened.

[0124] Figure 24-27 use Fig.23 The valve numbers shown in FIG. 1 are used as reference to illustrate various examples of valve configurations for pumping fluid through the cassette 16 for various portions of the compounding operation. Fig.24 In the example of , the valves of valve groups V1 and V2 are configured to pump diluent from a diluent container directly to a receiving container (e.g., valves P1 and P3 of group V1 are closed, valve P2 of group V1 is open, valves P1 and P2 of group V2 are closed, and valve P3 of group V2 is opened to form a fluid path 7300 from one of the diluent ports 3100 to a receiving container port 7302).

[0125] exist Fig.25In the example of , the valves of valve groups V1 and V2 are configured to pump diluent from the diluent container to the vial for reconstitution operation (e.g., valves P1 and P3 of group V1 are closed, valve P2 of group V1 is opened, valves P2 and P3 of group V2 are closed, and valve P1 of group V2 is opened to form a fluid path 7400 from one of the diluent ports 3100 to the vial port 7402). As shown, during the reconstitution operation, a hazardous vapor path 7404 can be formed from the vial waste port 7406 to the waste port 3100 to provide to the waste container 44. In some embodiments, a non-hazardous waste path 7408 can be provided from the non-hazardous vial waste port 7405 to the air filter port 7410. However, this is merely illustrative. In some embodiments, air filter port 7410 can be associated with an air filter check valve structure 3004 , 3004 , and 3006 that prevents any vapor waste from flowing along path 7408 and ensures that all vapor waste from vial 18 moves along path 7404 through waste port 3100 .

[0126] exist Fig.26 In the example of the embodiment of the present invention, the valves of valve groups V1 and V2 are configured to pump the reconstituted drug from the vial to the receiving container for the compounding operation (e.g., valves P1 and P2 of group V1 are closed, valve P3 of group V1 is opened, valves P1 and P1 of group V2 are closed, and valve P3 of group V2 is opened to form a fluid path 7500 from the vial port 7402 to the receiving container port 7302). As shown, during the compounding operation, the path 7502 can be formed from the air filter port 7410 to the non-hazardous vapor vial port 7405 to provide filtered sterile air from outside the cassette 16 to the vial to prevent the creation of a vacuum when the drug is pumped from the vial.

[0127] Although the receiving container 32 is in e.g. Figure 1 , 3 11 is shown as an IV bag, but in some scenarios, the receiving container 32 can be implemented as a syringe. For example, a tube connected to an output port (such as the receiving container port 7302) The connector can be connected to a needle-free valve connector (such as Connector), the The connector is connected to another needleless valve connector (e.g., another A connector) is provided which is connected to a syringe for receiving the reconstituted medicament. In the scenario where the receiving container is a syringe, it may be desirable to remove air or other vapors from the syringe after the medicament is pumped from the vial into the syringe.

[0128] exist Fig. 27In the example of , the valves of valve groups V1 and V2 are configured to pump air from a receiving container such as a syringe (e.g., valves P1 and P3 of group V1 are closed, valve P2 of group V1 is open, valves P2 and P3 of group V2 are closed, and valve P1 of group V2 is open to form a fluid path 7600 from the receiving container port 4302 to the waste port 3100). In some configurations, valves P1 and P2 of group V3 can be alternately opened and closed in coordination with the movement of piston pump 166 to move a desired fluid or vapor along the fluid path defined by valve 190.

[0129] Fig.28 is a diagram showing the Fig.23 The valve 190 marked in FIG. 1 is combined with Figure 24-27 The locations and operations during the various parts of the reconstruction / reconfiguration process are described.

[0130] Fig.29A 1 is a cross-sectional side view of the cassette 16, with the cross section being taken through the diluent port 3100D, the waste port 3100W and the receiving container port 7302. Fig.29A As shown in the example of , each diluent port 3100D can be formed by a portion of the membrane 162 formed within an opening in the baffle 164 and adjacent to the diluent chamber 8200D. The waste port 3100W can be formed by a portion of the membrane 162 formed within an opening in the baffle 164 and adjacent to the vapor waste chamber 8200W. The receiving container port 7302 can be formed by an opening leading to a receiving container chamber 8202, and a tube extending into the backpack 3202 can be disposed in the receiving container chamber to form a fluid path from the cassette 16 to the receiving container.

[0131] When the manifold membrane is sealed such as Fig.29B When the sealing manifold membrane 8252 of the manifold 8250 is compressed, the portion of the sealing membrane 162 that forms the diluent and / or waste port 3100 establishes a drip-free connection between the manifold 8250 and the cassette. The manifold needle 8254 of the selected diluent manifold 8250 and the manifold needle of the waste manifold can extend through the corresponding manifold membrane 8252 and the sealing membrane 162 in the corresponding diluent and waste ports to form a fluid path for diluent and waste vapors through the sealing membrane 162 (e.g., through the opening 8256 of the needle 8254, the central bore 8257, and the opening 8258) for reconstitution and compounding operations.

[0132] However, Fig.29AThe example of wherein the seals of ports 3100D and 3100W are formed by only a portion of the membrane 162 extending into the opening of the baffle 164 is merely illustrative. In some embodiments, to provide an improved drip-free seal, the seals of each of ports 3100D and 3100W may be formed by multiple sealing members. In one example, three sealing members may be provided to form the port seals for the cassette 16.

[0133] Fig.29C A cross-sectional view of a port of a cassette 16 is shown in an embodiment having three sealing members. Fig.29C As shown in FIG. 1 , a port 3100 (e.g., one of the diluent port 3100D or the waste port 3100W) can be formed by a portion of the membrane 162 disposed between an outer sealing member 8262 (formed in an opening 8260 in the baffle 164) and an inner sealing member 8264. The inner sealing member 8264 can be disposed between the membrane 162 and the chamber 8200.

[0134] like Fig.29C As shown in, the outer sealing member 8262 may include a portion extending through the opening 8260, and may also include a recess 8268 adjacent to the film 162 on the inner surface. The film 162 may also include a recess 8266 adjacent to the inner sealing member 8264 on the inner surface. Providing multiple sealing members such as three sealing members (i.e., members 8262, members 8264, and the portion of the film 162 formed between members 8262 and 8264) for the port 3100 can provide an enhanced wipe of the needle 8254, thereby providing an improved dry disconnection compared to an embodiment with a single sealing member. However, this is merely illustrative. In various embodiments, one, two, three, or more than three sealing members may be provided for each port. Similarly, the gap space formed by recesses 8266 and 8268 can further improve the wiping efficiency of the needle 8254, but in various embodiments, the sealing member may be provided with or without recesses 8266 and / or 8268.

[0135] Fig.29D Shows Fig.29B The manifold 8250 and the manifold sealing member 8252 are pressed against Fig.29C The outer sealing member 8262 of the port 3100. Fig.29D As shown in the figure, the needle 8254 extends from the manifold 8250 through the sealing members 8252 and 8262, through the gap space 8268, through the membrane 162, through the gap space 8266, and through the inner sealing member 8264, so that the openings 8256 and 8258 and the center bore 8257 form a fluid passage between the cassette 16 and the manifold 8250.

[0136] exist Fig.29A In the example of FIG. 1 , the portion of the membrane 162 that extends into the opening in the baffle 164 of the port 3100 can be compressed (e.g., radially compressed by 10%) to create a wiping effect on the diluent needle extending therethrough and removed therefrom, so that when the diluent needle is retracted into the manifold, no liquid remains on the diluent needle or on the outer surface of the cartridge or membrane.

[0137] exist Fig.29C and 29D In the example of FIG. 8 , the portion of the sealing member 8262 that extends into the opening in the baffle 164 of the port 3100 can be compressed (e.g., radially compressed by 10%) to produce a wiping effect on the diluent needle extending therethrough and removed therefrom, so that when the diluent needle is retracted into the manifold, no liquid remains on the diluent needle or the outer surface of the cartridge or membrane. Fig.29C and 29D The multiple sealing members can be configured to each provide a wiping effect on the needle 8254 that supplements the wiping effect of the other sealing members (e.g., by providing peak wiping forces on the needle for each member at locations angularly spaced apart relative to the peak wiping forces of the other members).

[0138] Fig.30 3 is a cutaway perspective side view of the cassette plus backpack assembly 3203, wherein it can be seen that the protrusions 3016 and protrusions 3304 of the cassette frame 160 cooperate to couple the cassette 16 to the backpack 3202 to form the cassette plus backpack assembly 3203. To mount the backpack 3202 to the cassette 16, the opening 3201 of the backpack 3202 can be positioned above the protrusions 3016, and the backpack 3202 can be rotated (e.g., in direction 3401) to push the latch features 3302 of the backpack 3202 against the latch protrusions 3304 until the latch protrusions 3304 snap into place between the latch features 3302. As shown, the protrusions 3016 can be formed on additional latch structures of the cassette 16, such as the flexible arms 3400. The flexible arms 3400 can allow the backpack 3202 to be pulled downward a short distance when the backpack 3202 is rotated to press the latching feature 3302 onto the protrusion 3304. The flexible arms 3400 can be resilient to maintain an upward force to hold the latching feature 3302 against the protrusion 3304 in the latched position.

[0139] exist Fig.30In the example of FIG. 1 , the vial 18 and the vial disk 26 are positioned adjacent to the cassette plus backpack assembly 3203, and the needle assembly 170 extends into the vial through the sealing member 3402 of the cassette 16 and the sealing member 3404 of the vial disk 26, which can provide a drip-free seal and allow fluid to be provided to and / or removed from the vial 18. The sealing member 3402 can be, for example, an embodiment of the sealing member 3008. As shown, when the needle assembly 170 extends into the vial, some portions of the vial disk 26 can be positioned adjacent to the latch feature 3302 of the backpack 3202.

[0140] Fig.31 A cross-sectional view of a portion of the cassette 16 and an enlarged view of a portion of the needle assembly 170 are shown. Fig.31 , the needle housing 186 may include a sealing membrane 3402 formed within an annular housing member 8404 that is attached to the cassette frame 160 via one or more housing arms 8408. A spring 8410 may be provided that extends from the needle housing 317B into the needle housing 186 such that compression of the spring 8410 is necessary to extend the needles 316 and 318 through the sealing membrane 3402. In this way, a user handling the cassette 16 is protected from injury by contact with the needle assembly 170. In operation, the vial disc may be pressed against the annular housing member 8404 to compress the spring 8410 such that the needle assembly 170 extends through the sealing membrane 3402 and through the sealing membrane of the vial disc into the vial.

[0141] Double-chamber needle 316 and 318 can be respectively provided with opening 8400 and 8402, and it provides fluid passage for the center bore of needle. Needle 316 can be for example the 24th needle that is maintained in the sheet box frame 160 by high-density polyethylene (HDPE) overmolding 317A, and this needle has the opening 8400 for discharging medicine vial.Opening 8400 can be formed using slot incision as shown in the figure, to reduce the coring of sealing membrane when needle inserts and retracts. Needle 318 can be for example the 18th needle that is maintained in the sheet box frame by high-density polyethylene (HDPE) overmolding 317B, has one or more openings 8402 for fluid to flow into and / or flow out of vial.Opening 8402 can comprise two drillings, and it is configured to reduce coring and allow the fluid flow rate of up to for example 60mL / min.

[0142] Thus, during a reconstitution operation, diluent can be provided to the vial via opening 8402 of needle 318, and vapor waste can be simultaneously removed from the vial via opening 8400 in needle 316. During a reconstitution operation, reconstituted medicament can be withdrawn from the vial via opening 8402 of needle 318, and sterile air can be provided to the vial via opening 8400 of needle 316.

[0143] Although various embodiments of the cartridge 16 have been described in which a linear oscillating piston pump (see, e.g., piston 166 of FIG. 21 ) is operated in conjunction with a finger-operated valve to move and direct fluid and / or gas through the cartridge 16 and from the diluent container and to the receiving container, in other embodiments, one or more rotary piston pumps / valves may be used to move fluid and / or gas through the various fluid flow paths of the cartridge 16. For example, the cartridge 16 may be provided with a dedicated rotary piston pump / valve for each process of the compounding machine 10 (e.g., reconstitution, compounding, etc.) that moves fluid and / or gas through the cartridge 16.

[0144] The embodiment of the sheet box 16 with rotary piston pump / valve can reduce component cost and the complexity of sheet box 16, because the same device can be used as both pump and stop valve.For example, in rotary piston pump / valve, when rotating, rotary piston pump / valve is used as pump, and when rotary piston pump / valve stops rotating, it is in fact used as stop valve, thereby prevents any fluid flow.Compared with other embodiments, the sheet box implemented with rotary piston pump / valve can also use the power of reduction to rotate the motor (for example, simple stepping or DC motor) that is used for rotary piston pump / valve.The embodiment of the sheet box 16 with rotary piston pump / valve can provide other benefits, comprise and prevent that the diluent line is exposed to pressure, and prevent that the waste line is exposed to vacuum.

[0145] Fig.32 An illustrative embodiment of a rotary piston pump / valve is shown. Fig.32 As shown in , the rotary pump / valve 13200 includes a housing 13201 in which a rotary piston 13204 is disposed. The rotary piston 13204 includes a cavity 13206 and is coupled to a gear 13202. The gear 13202 can engage with a corresponding gear of a pump head assembly so that the pump head assembly is rotated, thereby rotating the gear and thereby rotating the cavity 13206. The gear 13202 can have a cam surface. The housing 13201 can include an input port 13208 and an output port 13210.

[0146] like Fig.32 As shown in , when the gear 13202 and the rotary piston 13204 are rotated and positioned so that the cavity 13206 is adjacent to the input port 13208, the fluid (e.g., diluent, waste fluid, or reconstituted medication) is drawn into the cavity 13206 by the cam action on the gear 13202, which actuates the piston 13204 and the cavity 13206 downward during the introduction stroke. Fig.33As shown in , after the introduction stroke, the gear 13202 and the rotary piston 13204 rotate to a transition position with the fluid disposed within the cavity 13206, in which the cavity 13206 is rotationally interposed between the input port 13208 and the output port 13210. Fig.34 As shown in , after the transition, the gear 13202 and the rotating piston 13204 rotate to a certain position with the fluid set in the cavity 13206, in which position the cavity 13206 is rotationally aligned with the output port 13210, so that the fluid in the cavity 13206 is ejected through the output port 13210 by the cam action on the gear 13202, and the cam action causes the piston 13204 and the cavity 13206 to actuate upward in the ejection stroke.

[0147] Fig.35 FIG. 1 shows a front view of a cassette 16 in one embodiment in which the cassette is provided with a series of rotary piston pumps / valves 13200 actuated by a compounding machine. Fig.35 As shown in , the cassette 16 may include up to or more than five rotary piston pump / valves 13200, each disposed within an associated fluid pathway of the cassette 16 to move or prevent fluid from moving through the associated fluid pathway. The rotary piston pump / valves 13200 may be operated individually or in combination to move fluid from one or more of the diluent ports 13500 to the output port 13506, from the syringe input / output port 13504 to or from the output port 13506, from the output port 13506 or the syringe input / output port 13504 to the waste port 13502, from the output port 13506 to the air filter, and / or between any other ports of the cassette 16, depending on the compounding machine operation.

[0148] As above combined Figure 32-34 As described, as each rotary piston pump / valve 13200 in the cartridge 16 rotates, there is translational movement of the piston in a downward direction which draws fluid from a portion of the associated fluid pathway in the cartridge 16 into the rotary piston pump / valve 13200. As the rotary piston continues to rotate, the cam action forces the piston upward and forces the fluid in the chamber through the output port to another portion of the associated fluid pathway in the cartridge 16. This rotary piston pump / valve is unique in that when the rotary motion stops, it prevents fluid from flowing through the rotary piston pump / valve, which then acts in effect as a shut-off valve.

[0149] In some embodiments, the cassette 16 may be provided with a syringe pump having a syringe valve instead of (or in addition to) the linear oscillating piston pump and / or rotary piston pump having a finger valve as described above. Fig.361 shows an example of a syringe pump / syringe valve device that may be provided to control the movement of fluids and / or gases through the cassette 16. Fig.36 As shown in , the syringe pump / syringe valve device 13600 may include a housing 13601 for a syringe pump 13604 and a plurality of syringe valves 13602. The syringe pump 13604 may be actuated by a pump head assembly to push or draw fluid through the device 13600. The direction of flow of the fluid through the device 13600 and the input and output positions may be controlled by the positioning of one or more of the syringe valves 13602. The plunger 13606 of each of the syringe valves 13602 may be raised or lowered to open or close the corresponding port 13608. In Fig.36 In the example of , four of the five syringe valves 13602 are closed and one syringe valve plunger is raised to establish a cavity 13610 that forms a passage to the corresponding port 13608.

[0150] Fig.37 A perspective view of the housing 13601 is shown, wherein the flow passage 13704 between the main cylinder 13702 for the syringe pump 13604 and the plurality of valve cylinders 13700 can be seen. Fig.38 As shown in , a bottom or base plate 13800 can be attached (e.g., welded) to the housing 13601 to enclose a fluid pathway (e.g., fluid pathway 13704) within the housing.

[0151] Figure 39-46 Various configurations of the syringe valve 13602 and the movement of the syringe pump 13604 for various operations of the compounding machine 10 are shown. Fig.39 and 40 The example of shows the valve and piston operation for the reconfiguration operation. Fig.39 In the example of , the plunger of the syringe piston 13604 is raised and the syringe valve 13602 connected to the diluent bag is opened to draw the diluent into the syringe piston. Fig.40 In the example of , the syringe valve 13602 connected to the diluent bag is closed, the syringe valve 13602 connected to the vial 18 is opened, and the plunger of the syringe piston 13604 is lowered to push the diluent therein toward the vial. Fig.40 As shown in , the device 13600 can include redundant check valves 14000 and 14002 to prevent undesired flow (e.g., originating from a waste container or going to a diluent bag).

[0152] Fig.41 and 42 The example of shows the valve and piston operation for compounding operation. Fig.41In the example of , the plunger of the syringe piston 13604 is raised and the syringe valve 13602 connected to the vial 18 is opened to draw the reconstituted medicament from the vial into the syringe piston. Fig.42 In the example of , the syringe valve 13602 connected to the vial 18 is closed, the syringe valve 13602 connected to the receiving container 32 (e.g., a dose bag) is opened, and the plunger of the syringe piston 13604 is lowered to push the reconstituted agent therein toward the receiving container.

[0153] Fig.43 and 44 The example of shows the valve and piston operation for air purge operation. Fig.43 In the example of , the plunger of the syringe piston 13604 is raised and the syringe valve 13602 connected to the air filter (e.g., the air filter between the ambient air port and the device 13600) is opened to draw filtered air from the environment into the syringe piston. Fig.44 In the example of , the syringe valve 13602 connected to the air filter is closed, the syringe valve 13602 connected to the receiving container 32 (e.g., a dose bag) is opened, and the plunger of the syringe piston 13604 is lowered to push the filtered air therein toward the receiving container (e.g., via a tube such as a "pigtail" tube between the cassette 16 and the receiving container).

[0154] Fig.45 and 46 The example of shows the valve and piston operation for vacuum operation. Fig.45 In the example of , the plunger of the syringe piston 13604 is raised and the syringe valve 13602 connected to the receiving container 32 is opened to draw waste gas from the receiving container into the syringe piston. Fig.46 In the example of , the syringe valve 13602 coupled to the receiving container is closed, the syringe valve 13602 coupled to the waste container 44 is opened, and the plunger of the syringe piston 13604 is lowered to push the waste gas therein toward the waste container. Fig.47 The apparatus 13600 is shown coupled to the cartridge 16 in a position where a syringe plunger of a syringe pump and a syringe piston can be operated by a pump head assembly to control the flow of fluids and gases through the cartridge 16 (e.g., as described above in conjunction with Figure 39-46 described).

[0155] exist Figure 36-47 In the example of FIG. 1 , a large syringe-style pump provides the pumping action for the compounding machine 10, and the valves used to control the various processes are syringe-type valves. The syringe-type valves can be used to obtain reliability and simplicity. As shown in the above combination Figure 39-46As described, each of the different processes of the compounding machine 10 can be assigned to a syringe valve, and in many cases, only one syringe valve will be opened at any one time. For example, during the reconstitution process, when the syringe pump draws fluid into the syringe pump, the syringe valve leading to the diluent bag will be opened. Once the syringe pump chamber is full, the diluent bag syringe valve will be closed, and the vial syringe valve will be opened. Once the vial syringe valve is opened, the syringe pump pushes the diluent fluid into the vial. Similar processes of syringe pump and valve operation can be repeated for all different processes of the compounding machine 10.

[0156] In some embodiments, cassette 16 may be provided with a syringe pump and one or more rotary valves instead of (or in addition to) a linear oscillating piston pump, a rotary piston pump, or a syringe piston pump / valve device with a finger valve as described above. Fig.48 An example of a syringe pump / rotary valve device is shown, which may be provided to control the movement of fluids and / or gases through the cassette 16. Fig.48 As shown in , the syringe pump / rotary valve device 14800 may include a syringe pump 14802 having an actuatable plunger 14804 and a valve cluster 14806 having output ports 14808. Each output port 14808 may be selectively fluidly coupled (through operation of a valve within the valve cluster 14806) to a chamber within the syringe pump 14802.

[0157] Fig.49 A front perspective view of a syringe pump / rotary valve device 14800 is shown, with the housing shown in a partially transparent manner so that the seal 14902 on the plunger 14804, the internal fluid passage 14904, and the internal valve features of the rotary valves 14900 in the valve cluster 14806 can be seen. As shown, the fluid passage 14904 can fluidly couple the chamber of the syringe pump 14802 to the rotary valves 14900, each of which can be rotated by the pump head assembly during actuation of the plunger 14804 to couple the passage 14904 to the port 14808. Fig.50 A front perspective view of a syringe pump / rotary valve device 14800 is shown having an opaque housing through which a valve handle 15000 protrudes to allow rotational operation of a valve 14900 via a pump head assembly. Fig.51 The syringe pump / rotary valve device 14800 is shown coupled to the cartridge 16 in a position where the syringe plunger of the syringe piston rotary valve 14900 can be operated by the pump head assembly to control the flow of fluids and gases through the cartridge 16.

[0158] Fig.52 A perspective view of one of the rotary valves 14900 in an embodiment where the rotary valve is implemented as a plug rotary valve is shown. Fig.52, rotary valve 14900 includes openings 15204 disposed about the periphery of a cylindrical inner valve member 15202 that is rotatable by a valve handle 15000. Rotating the valve handle 15000 rotates the position of the openings 15204 relative to a fluid passage 15206 of the device 14800 to open and close the valve.

[0159] exist Figure 48-52 In the example of, the cassette 16 has a large syringe style pump, and the valve used to control various processes is a rotary stopcock style valve. Rotary valves can be used to obtain their reliability and simplicity. Each of the different processes performed by the compounding machine 10 can be performed using a distributed rotary valve, and in many scenarios, only one rotary valve will be opened at any one time. For example, during the reconstruction process, when the syringe pump draws fluid into the syringe pump, the rotary valve controlling the fluid path leading to the diluent bag will be opened. Once the syringe pump chamber is full, the diluent bag valve will be closed, and the vial rotary valve will be opened. Once the vial rotary valve is opened, the syringe pump pushes the diluent fluid into the vial. The similar process of the syringe pump and the rotary valve operation can be repeated for all different processes of the compounding machine 10.

[0160] Various examples have been described herein in which the cartridge 16 is coupled to the pump head assembly 28 via a snap-fit ​​or other positive latch mechanism operated by the pump head assembly. However, a positive latch mechanism such as a snap-fit ​​may be operated using a stepper or DC motor to actuate the latch mechanism, which may increase the cost and complexity of the compounding machine. Accordingly, it should be understood that in some embodiments, the pump head assembly 28 may be provided with one or more magnets 15300 (see Fig.53 ) in order to electromagnetically attach the cassette 16 to the pump head assembly 28.

[0161] Magnet 15300 can be active or passive magnet, and it is configured to temporarily attach cassette to compounding arm. Magnet 15300 can be installed to the arm face on compounding machine at the position corresponding to the corresponding metal plate or other ferromagnetic member attached to cassette 16. When cassette 16 moves towards the arm face, magnet is enabled to attract and attach cassette to the arm face. When cassette is to be returned to the rotating disk, magnet can be deactivated (for example, after cassette is docked in the rotating disk). Magnetic coupling can be used independently or in combination with positive mechanical latch mechanism.

[0162] In this paper, for example Figure 32-53The various features described may be used alone or in combination with each other and / or in conjunction with the features described in FIGS. 1-31 to help provide a simple high flow fluid path and / or a simple rotary valve, to facilitate reducing or eliminating the need for priming and / or air flushing of tubing such as "pigtail" tubing, to help provide a flow path that is easily inspected for leaks during production, to provide a slow-motion syringe pump that helps reduce or eliminate foaming and / or damage to the medication, to facilitate the use of a common cartridge for both micro and routine dosing, to help reduce interaction between the pump head assembly (pump arm) and the cartridge, to help facilitate the use of a single dose waste container, to help facilitate the use of a single vial needle, to provide individual independent valve control for flexibility in the control process, to facilitate the use of an in-line air sensor in a tubing such as a "pigtail" tubing leading to a receiving container, and / or to facilitate the use of a single vial needle relative to a combination. Figure 1-31 Some of the features described and / or in existing systems reduce tolerances.

[0163] The present disclosure is provided to allow any person skilled in the art to implement the various aspects described herein. The present disclosure provides various examples of the present technology, and the present technology is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein may be applicable to other aspects.

[0164] For example, the present technology is illustrated according to the above-mentioned various aspects. For convenience, various examples of these aspects are described as numbered concepts or clauses (1, 2, 3, etc.). These concepts or clauses are provided as examples and do not limit the present technology. It should be noted that any of the dependent concepts can be combined with each other or one or more other independent concepts in any combination to form an independent concept. The following is a non-limiting summary of some concepts proposed in this article:

[0165] Concept 1. A compounding machine system, comprising:

[0166] A cassette having:

[0167] a plurality of controllable fluid passages fluidly coupled to at least one of the diluent port, the waste port, and the receiving container port; and

[0168] A syringe pump / syringe valve apparatus having a plurality of syringes operable to control the movement of one or more fluids through the plurality of controllable fluid pathways.

[0169] Concept 2. The compounder system of Concept 1 or any other concept, wherein the syringe pump / syringe valve device comprises a housing having a syringe pump cylinder with a syringe pump plunger, a plurality of syringe valve cylinders, and a fluid flow path between the syringe pump cylinder and the plurality of syringe valve cylinders.

[0170] Concept 3. The compounder system of Concept 2 or any other concept, wherein each of the syringe valve cylinders comprises a port and a syringe plunger, the syringe plunger being actuatable to open and close the port.

[0171] Concept 4. The compounder system of Concept 3 or any other concept, wherein the plurality of syringe valve cylinders include: a diluent cylinder having a diluent port configured to be coupled to a diluent container; and a vial cylinder having a vial port configured to be coupled to a vial containing a medicament.

[0172] Concept 5. The compounding machine system as described in Concept 4 or any other concept further comprises a pump head, which comprises one or more actuatable components, wherein the actuatable components are configured to:

[0173] opening the diluent port by moving a syringe plunger in the diluent cylinder; and

[0174] The syringe pump plunger is moved in a first direction within the syringe pump cylinder to draw diluent into the syringe pump cylinder through the diluent port.

[0175] Concept 6. A compounding machine system as described in Concept 5 or any other concept, wherein the actuatable component is further configured as:

[0176] closing the diluent port by moving a syringe plunger in the diluent cylinder;

[0177] opening the vial port by moving a syringe plunger in the vial cylinder; and

[0178] The syringe pump plunger is moved in a second direction to push diluent from the syringe pump cylinder through the vial port.

[0179] Concept 7. A compounding machine system as described in Concept 6 or any other concept, wherein the actuatable component is further configured as:

[0180] moving the syringe pump plunger in a first direction within the syringe pump cylinder to draw medication into the syringe pump cylinder through the vial port;

[0181] closing the vial port by moving a syringe plunger in the vial cylinder;

[0182] opening an output port by moving a syringe plunger in an output cylinder of the plurality of syringe valve cylinders; and

[0183] The syringe pump plunger is moved in a second direction to push medication from the syringe pump cylinder through the output port.

[0184] Concept 8. A compounder system as described in Concept 3 or any other concept, wherein the fluid flow path is coupled to each of the syringe valve cylinders through a corresponding coupling cylinder in the housing, wherein each of the coupling cylinders extends from a corresponding one of the plurality of syringe valve cylinders in a first direction, and wherein a port of each of the syringe valve cylinders extends from the syringe valve cylinder in a second direction perpendicular to the first direction.

[0185] Concept 9. A compounding machine system, comprising:

[0186] A cassette having:

[0187] a plurality of controllable fluid passages fluidly coupled to at least one of the diluent port, the waste port, and the receiving container port; and

[0188] A syringe pump / rotary valve apparatus having a syringe and a plurality of rotary valves operable to control the movement of one or more fluids through the plurality of controllable fluid pathways.

[0189] Concept 10. The compounder system of Concept 9 or any other Concept, wherein at least one of the rotary valves is a plug rotary valve.

[0190] Concept 11. The compounder system of Concept 9 or any other concept, further comprising a pump head assembly, wherein each of the rotary valves comprises an external valve handle, and wherein the pump head assembly is configured to actuate the syringe and rotate one or more of the external valve handles to control movement of one or more fluids through the controllable fluid passage.

[0191] Concept 12. The compounder system of Concept 11 or any other concept, wherein each of the rotary valves can be rotated by an external valve handle of the rotary valve to selectively couple a port corresponding to the rotary valve with a chamber of the syringe.

[0192] Concept 13. The compounder system of Concept 12 or any other concept, wherein a port corresponding to each rotary valve extends into the cassette.

[0193] Concept 14. The compounder system of Concept 11 or any other concept, wherein each rotary valve comprises first and second openings disposed around a periphery of a cylindrical inner valve member, the cylindrical inner valve member being rotatable by an outer valve handle of the rotary valve.

[0194] Concept 15. A compounding machine system as described in Concept 14 or any other concept, wherein:

[0195] In a first rotational position of each cylindrical inner valve member, the first and second openings of the cylindrical inner valve member are aligned with corresponding fluid passages in the syringe pump / rotary valve device to allow fluid flow through the cylindrical inner valve member; and

[0196] In the second rotational position of each cylindrical inner valve member, at least one of the first and second openings of the cylindrical inner valve member is angularly separated from both of the corresponding fluid passages in the syringe pump / rotary valve device to prevent fluid flow through the cylindrical inner valve member.

[0197] Concept 16. A compounding machine system, comprising:

[0198] A cassette having:

[0199] multiple controllable fluid pathways;

[0200] Syringe pumps; and

[0201] A plurality of valves operable to selectively couple the syringe pump to one or more of the plurality of controllable fluid pathways.

[0202] Concept 17. The compounder system of claim 16 or any other concept, wherein said plurality of valves includes at least one syringe valve.

[0203] Concept 18. The compounder system of Concept 17 or any other Concept, further comprising a common housing for the syringe pump and the at least one syringe valve, the common housing comprising a fluid passage between the syringe pump and the at least one syringe valve.

[0204] Concept 19. The compounder system of Concept 16 or any other Concept, wherein said plurality of valves comprises at least one rotary valve.

[0205] Concept 20. The compounder system of Concept 19 or any other Concept, wherein the at least one rotary valve comprises a plug rotary valve.

[0206] One or more aspects or features of the subject matter described herein may be implemented in digital electronic circuits, integrated circuits, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. For example, the infusion pump system disclosed herein may include an electronic system having 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. The electronic system may include, for example, a bus, a processing unit, a system memory, a read-only memory (ROM), a permanent storage device, an input device interface, an output device interface, and a network interface.

[0207] The bus may collectively represent all system, peripheral, and chipset buses that communicatively connect the numerous internal devices of the electronic system of the infusion pump system. For example, the bus may communicatively connect the processing unit with the ROM, system memory, and permanent storage. From these various storage units, the processing unit may retrieve instructions to be executed and data to be processed in order to perform various processes. In different embodiments, the processing unit may be a single processor or a multi-core processor.

[0208] Reference to an element in the singular is not intended to mean "one and only one," unless specifically so described, but rather "one or more." Unless specifically stated otherwise, the term "some" means one or more. Pronouns in the masculine gender (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are for convenience only and do not limit the invention.

[0209] 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, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0210] As used herein, the phrase "at least one of" following a list of items (with the term "or" separating any of the items) modifies the list as a whole, rather than each item in the list. The phrase "at least one of" does not require selection of at least one item; rather, the phrase allows for a meaning that includes at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrase "at least one of A, B, or C" may mean: only A, only B, or only C; or any combination of A, B, and C.

[0211] Phrases such as "aspects" do not imply that such aspects are essential to the present technology or that such aspects apply to all configurations of the present technology. The disclosure related to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiments" do not imply that such embodiments are essential to the present technology or that such embodiments apply to all configurations of the present technology. The disclosure related to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "constructions" do not imply that such constructions are essential to the present technology or that such constructions apply to all configurations of the present technology. The disclosure related to a construction may apply to all configurations, or one or more configurations. A construction may provide one or more examples. Phrases such as "constructions" may refer to one or more constructions, and vice versa.

[0212] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions and other specifications given in this specification (including in the following claims) are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and the customary practices in the field to which they belong.

[0213] It should be understood that the specific order or hierarchy of steps or operations in the disclosed process or method is an illustration of an exemplary scheme. Based on implementation preferences or scenarios, it should be understood that the specific order or hierarchy of steps, operations or processes can be reconfigured. Some of the steps, operations or processes can 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 can be performed automatically without user intervention. The accompanying method concept proposes the elements of each step, operation or process in a sample order and is not intended to be limited to the specific order or hierarchy proposed.

[0214] All structural and functional equivalents of the elements of the various aspects described throughout this disclosure that are known or will become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be included in the concept. In addition, nothing disclosed herein is intended to be contributed to the public, regardless of whether such disclosure is explicitly recorded in the concept. Concept elements shall not be interpreted under the provisions of 35 U.S.C. §112(f) unless the element is explicitly recorded using the phrase "device for XX" or, in the case of a method claim concept, the element is recorded using the phrase "step for XX". Further, to the extent that the terms "including", "having", etc. are used, such terms are intended to be inclusive, in a manner similar to the term "comprising", as "comprising" is interpreted when it is adopted as a transitional word in the concept.

[0215] The title, background technology, content of the invention, description of the drawings and abstract of the present disclosure are incorporated into the present disclosure at this time, and are provided as illustrative examples of the present disclosure, rather than as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the concept. In addition, in the specific embodiments, it can be seen that the description provides illustrative examples, and various features are combined together in various embodiments for the purpose of making the present disclosure fluent. This disclosed method should not be interpreted as reflecting such an intention that the required subject matter requires more features than those explicitly listed in each concept. On the contrary, as reflected in the following concept, the subject matter of the invention is in less than all the features of a single disclosed structure or operation. The following concept is incorporated into the specific embodiments at this time, and each concept exists alone as a separately disclosed subject matter.

[0216] The concepts are not intended to be limited to the aspects described herein, but should be given the full scope consistent with the language concept and encompass all legal equivalents. Nevertheless, no concept is intended to include subject matter that does not satisfy the requirements of 35 U.S.C. §101, 102, or 103, nor should they be interpreted in such a manner.

Claims

1. A compounder system (10) for reconstitute, mix and deliver a drug from a vial to a receiving container, comprising: A cassette (16) comprising: a plurality of controllable fluid passages fluidly coupled to at least one of the diluent port, the waste port, and the receiving container port; a syringe pump (13604) comprising a syringe pump cylinder and a syringe pump plunger actuatable within the syringe pump cylinder to allow fluid flow; and At least one syringe valve (13602), each syringe valve comprising a plunger (13606) and a port (13608), wherein the plunger (13606) in the syringe valve is capable of being raised or lowered to open or close the port (13608) of the syringe valve to selectively connect the syringe pump (13604) to one or more of the plurality of controllable fluid pathways.

2. The compounding machine system (10) according to claim 1, wherein: The compounding machine system further includes a common housing (13601) for the syringe pump (13604) and the at least one syringe valve (13602), the common housing (13601) including a syringe pump cylinder (13702), a plurality of syringe valve cylinders (13700) and a fluid flow passage (13704) between the syringe pump cylinder (13702) and the plurality of syringe valve cylinders (13700).

3. The compounding machine system (10) according to claim 2, wherein: The plurality of syringe valve cylinders (13700) include: a diluent cylinder having a diluent port (3100) configured to be coupled to a diluent container; and a vial cylinder having a vial port configured to be coupled to a vial containing a medicament.

4. The compounder system (10) of claim 3, further comprising a pump head assembly (28) comprising one or more actuatable components, wherein the actuatable components are configured to: The diluent port (3100) is opened by moving the syringe plunger in the diluent cylinder; and the syringe pump plunger is moved in a first direction within the syringe pump cylinder (13702) to draw the diluent into the syringe pump cylinder (13702) via the diluent port.

5. The compounding machine system (10) according to claim 4, wherein: The actuatable component is further configured as follows: closing the diluent port (3100) by moving the syringe plunger in the diluent cylinder; opening the vial port by moving a syringe plunger in the vial cylinder; as well as The syringe pump plunger is moved in a second direction to push diluent from the syringe pump cylinder (13702) through the vial port.

6. The compounding machine system (10) according to claim 5, wherein: The actuatable component is further configured as follows: moving the syringe pump plunger in a first direction within the syringe pump cylinder (13702) to draw medication into the syringe pump cylinder (13702) through the vial port; closing the vial port by moving a syringe plunger in the vial cylinder; opening an output port by moving a syringe plunger in an output cylinder of the plurality of syringe valve cylinders (13700); as well as The syringe pump plunger is moved in a second direction to push medication from the syringe pump cylinder (13702) through the output port.

7. The compounding machine system (10) according to claim 2, wherein: The fluid flow path is connected to each of the syringe valve cylinders (13700) through a corresponding connecting cylinder in the housing (13601), wherein each of the connecting cylinders extends from a corresponding one of the plurality of syringe valve cylinders (13700) along a first direction, and wherein the port (13608) of each of the syringe valve cylinders (13700) extends from the syringe valve cylinder along a second direction perpendicular to the first direction.

8. A compounder system (10) for reconstitute, mix and deliver a drug from a vial to a receiving container, comprising: A cassette (16) comprising: a plurality of controllable fluid passages fluidly coupled to at least one of the diluent port, the waste port, and the receiving container port; a syringe pump comprising a syringe pump cylinder and a syringe pump plunger actuatable within the syringe pump cylinder to allow fluid flow; as well as At least one rotary valve (14900), each rotary valve comprising an external valve handle (15000) and an output port (14808), wherein the external valve handle (15000) of the rotary valve is configured to be rotated by the pump head assembly (28) to connect the output port (14808) of the rotary valve to the controllable fluid passage, thereby controlling the movement of one or more fluids through the controllable fluid passage.

9. The compounding machine system (10) according to claim 8, wherein: The at least one rotary valve (14900) comprises a plug rotary valve.

10. The compounding machine system (10) according to claim 9, wherein: The plug rotary valve includes a plurality of openings (15204) disposed around the periphery of a cylindrical inner valve member (15202) that is rotatable by a valve handle (15000).

11. The compounding machine system (10) according to claim 10, wherein: Rotating the valve handle (15000) rotates the position of the opening (15204) relative to one or more of the plurality of controllable fluid passages to open and close the rotary stopcock valve.

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