Rotary valve pump for automated pharmaceutical compounding machines

Abstract

Various aspects of this disclosure relate to a compounding system having a cartridge including a controllable fluid passage. One or more rotary piston pumps / valvees may be used to move fluid and / or gas through the respective fluid passages of the cartridge. For example, the cartridge may include a dedicated rotary piston pump / valve for each process, which moves fluid and / or gas through the cartridge. When rotating, the rotary piston pump / valve acts as a pump to move the fluid or gas, and when the rotary piston pump / valve stops rotating, it effectively acts as a shut-off valve to prevent any fluid flow. A magnetic coupler for the cartridge may be disposed on the pump head of the compounding system.

Description

[0001] This application is a divisional application of the invention application filed on March 23, 2018, with application number 201880033640.9 and entitled "Rotary Valve Pump for Automatic Pharmaceutical Compounding Machine".

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 476,683, filed 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] This disclosure generally relates to apparatus for reconstituted, mixed, and conveyed pharmaceutical preparations from vials to receiving containers. More specifically, this disclosure relates to the pump and valve features of a closed-system automated pharmaceutical preparation machine. Background Technology

[0005] Drug compounding is the practice of creating specific pharmaceutical products to meet the unique needs of patients. In practice, compounding is typically performed by pharmacists, technicians, or nurses using various tools to combine appropriate ingredients. A common form of compounding involves combining powdered pharmaceutical preparations with specific diluents to create a suspension of the drug composition. These types of compositions are commonly used for intravenous / parenteral medications. It is crucial that the drug and diluent remain sterile during the compounding process, and there is a need to automate this process while maintaining proper mixing characteristics (i.e., certain drugs must be agitated in a specific way so that the drug is properly mixed into the solution, but the solution does not foam and does not generate air bubbles). There is a need for a compounding system that is easy to use, can be used frequently and efficiently, is reliable, and minimizes user error. Summary of the Invention

[0006] The reconstituted system pumps diluent from a diluent container to a vial containing the medication, and then pumps the reconstituted medication to a receiving container. To ensure that each medication is correctly and safely reconstituted and moved to the receiving container without mixing or leakage, a disposable tablet cartridge is provided that connects the diluent container and the receiving container to the vial, and includes a fluid passage controlled by a valve on the cartridge for pumping fluid to and from the vial and container.

[0007] The pump component of the cartridge is actuable to move fluid and control the fluid movement through a controlled fluid passage. In some examples, the pump component may include a rotary pump / valve mechanism.

[0008] According to various aspects of this disclosure, a compounding system is provided, comprising a cartridge having: a plurality of controllable fluid passages fluidly coupled to at least one diluent port, a waste port, and a receiving container port; and a rotary piston pump / valve rotatable to control the movement of fluid through at least one of the controllable fluid passages.

[0009] According to other aspects of this disclosure, a cartridge for a reconstituter system is provided, the cartridge comprising: a first fluid passage extending from a diluent port to a vial connector; and a first rotary piston pump / valve disposed in the first fluid passage, rotatable to control movement of diluent from the diluent port to the vial connector, and configured to stop rotation to prevent movement of diluent within the first fluid passage.

[0010] According to other aspects of this disclosure, a compounding system is provided, comprising a cartridge having: a plurality of controllable fluid passages fluidly coupled to at least one diluent port, a waste port, and a receiving container port; and at least one ferromagnetic member. The compounding system further includes: a pump head assembly having at least one mechanism operable to control fluid flow through the plurality of controllable fluid passages; and a magnet configured to attach the cartridge to the pump head assembly using the at least one ferromagnetic member. Attached Figure Description

[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 showing an example of an exemplary embodiment of a compounding system according to some aspects of this disclosure.

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

[0014] Figure 3 This illustrates some aspects of the present disclosure in the case where the housing is removed. Figure 1 A side view of the compounding system.

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

[0016] Figure 5 Some aspects of this disclosure are shown. Figure 4 An exploded view of the pump drive mechanism.

[0017] Figure 6 A perspective view of a pump head assembly having a clamping system and a vial disc, according to some aspects of this disclosure, is shown.

[0018] Figure 7 Some aspects of this disclosure are shown. Figure 6 A perspective view of the pump head assembly, clamping system, and vial disc.

[0019] Figure 8 This is a flowchart illustrating exemplary embodiments of the steps of a process according to some aspects of this disclosure.

[0020] Figure 9 A perspective view of an exemplary embodiment of a cartridge according to some aspects of this disclosure is shown.

[0021] Figure 10 A perspective view of an exemplary embodiment of a turntable with a cover, according to some aspects of this disclosure, is shown.

[0022] Figure 11 A front perspective view of another exemplary embodiment of a compounding system according to some aspects of this disclosure is shown.

[0023] Figure 12 This illustrates some aspects of the present disclosure in the case where some portions of the housing are removed. Figure 11 Front perspective view of the compounding system.

[0024] Figure 13 This illustrates some aspects of the present disclosure in the case where some portions of the housing are removed. Figure 11 Rear perspective view of the compounding system.

[0025] Figure 14 The following diagram illustrates various components shown in enlarged views for clarity, according to some aspects of this disclosure. Figure 11 A perspective view of the compounding system.

[0026] Figure 15 Some aspects of this disclosure are shown. Figure 9 A perspective view of the film box.

[0027] Figure 16 The following are shown: A transparent baffle is provided according to some aspects of this disclosure. Figure 9 A perspective view of the film box.

[0028] Figure 17 A perspective view of an exemplary embodiment of a cassette with a backpack attachment according to some aspects of this disclosure is shown.

[0029] Figure 18The following are shown: a backpack attachment with a transparent design according to some aspects of this disclosure. Figure 17 A perspective view of the film box.

[0030] Figure 19 An exploded perspective view of another embodiment of a pump cartridge according to some aspects of this disclosure is shown.

[0031] Figure 20A Some aspects of this disclosure are shown. Figure 19 Rear view of the disc box.

[0032] Figure 20B Some aspects of this disclosure are shown. Figure 19 Front view of the disc box.

[0033] Figure 21 The following are shown: a backpack with attachment according to some aspects of this disclosure. Figure 19 A cross-sectional perspective view of the film box.

[0034] Figure 22 Some aspects of this disclosure are shown. Figure 19 A sectional side view of the film box.

[0035] Figure 23 The display valve and fluid flow path are shown according to some aspects of this disclosure. Figure 19 The box of films.

[0036] Figure 24 The illustration shows a valve configuration for a fluid path from the diluent to the receiving container, according to some aspects of this disclosure. Figure 19 The box of films.

[0037] Figure 25 The diagram illustrates a valve configuration for reconstructing the fluid path, according to some aspects of this disclosure. Figure 19 The box of films.

[0038] Figure 26 The diagram illustrates the valve configuration from which the compounding fluid path originates, according to some aspects of this disclosure. Figure 19 The box of films.

[0039] Figure 27 The illustration shows a valve configuration for an air removal fluid path according to some aspects of this disclosure. Figure 19 The box of films.

[0040] Figure 28 It is a diagram showing the positioning of certain valves according to some aspects of this disclosure.

[0041] Figure 29A This illustration shows a display of multiple ports according to some aspects of this disclosure. Figure 19 A sectional side view of the film box.

[0042] Figure 29B This disclosure illustrates some aspects that can be combined with Figure 29A A cross-sectional side view of a portion of the diluent manifold, where one of the ports is joined to a needle.

[0043] Figure 29C The illustration shows a port seal formed by multiple sealing members according to some aspects of this disclosure. Figure 19 A cross-sectional side view of a portion of the film box.

[0044] Figure 29D This illustrates the pressure of some aspects according to this disclosure. Figure 29C Figure 29B shows a cross-sectional side view of a portion of the manifold, representing a part of the film cassette.

[0045] Figure 30 A cross-sectional perspective view of a cassette arranged adjacent to a vial according to some aspects of this disclosure is shown.

[0046] Figure 31 This illustrates some aspects of the double-lumen needle in the vicinity of this disclosure. Figure 19 A cross-sectional side view of a portion of the film box.

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

[0048] Figure 33 This illustrates, according to some aspects of the present disclosure, the transition period between the inlet stroke and the outlet stroke. Figure 32 A partial cross-sectional view of a rotary piston pump / valve.

[0049] Figure 34 Some aspects of this disclosure are shown. Figure 32 A partial cross-sectional view of a rotary piston pump / valve during the ejection stroke.

[0050] Figure 35 A front view of a compounding cartridge with a rotary piston pump / valve according to some aspects of this disclosure is shown.

[0051] Figure 36 A perspective view of a syringe pump / syringe valve device according to some aspects of this disclosure is shown.

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

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

[0054] Figure 39 and 40 The configuration of a syringe pump / syringe valve device according to some aspects of this disclosure during a reconfiguration operation is shown.

[0055] Figure 41 and 42 The configuration of a syringe pump / syringe valve device according to some aspects of this disclosure during compounding operations is shown.

[0056] Figure 43 and 44 The configuration of a syringe pump / syringe valve device according to some aspects of this disclosure during an air purging operation is shown.

[0057] Figure 45 and 46 The configuration of a syringe pump / syringe valve device according to some aspects of this disclosure during waste gas removal operations is shown.

[0058] Figure 47 A syringe pump / syringe valve device attached to a compounding cartridge is shown according to some aspects of this disclosure.

[0059] Figure 48 A perspective view of a syringe pump / rotary valve device according to some aspects of this disclosure is shown.

[0060] Figure 49 Another perspective view of a syringe pump / rotary valve device according to some aspects of this disclosure is shown.

[0061] Figure 50 Another perspective view of a syringe pump / rotary valve device according to some aspects of this disclosure is shown.

[0062] Figure 51 A syringe pump / rotary valve device attached to a compounding cartridge is shown according to some aspects of this disclosure.

[0063] Figure 52 A perspective view of the rotary valve of a syringe pump / rotary valve device according to some aspects of this disclosure is shown.

[0064] Figure 53 A perspective view of a pump head assembly having a magnet for attaching a reassembly cartridge is shown, according to some aspects of this disclosure. Detailed Implementation

[0065] The detailed description given below describes various constructions of the present technology and is not intended to represent the only constructions that can implement the present technology. To provide a thorough understanding of the present technology, the detailed description includes specific details. Accordingly, dimensions may be provided with respect to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the present technology can 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 this 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 not limiting, examples. The various embodiments described in this disclosure may be implemented in different ways and variations and according to the desired application or implementation.

[0067] This system includes several features and technologies that together form a compounding system that can effectively reconstitute drugs in a sterile environment and deliver compounded drugs to delivery bags for use by patients.

[0068] Figure 1 A compounding machine system 10 according to one embodiment is shown. Figure 2 A system 10 with a transparent outer housing 12 is shown, while Figure 3 The system is shown with the housing removed. The system includes a turntable assembly 14 containing up to 10 individual cartridges 16. The turntable 14 can hold more or fewer cartridges 16 if needed. The cartridges 16 are disposable and provide a unique fluid path between vials 18 containing powdered (or concentrated liquid) agents, multiple diluents, and a receiving container. The cartridges 16 can also provide a fluid path to a vapor waste container if needed. However, in other embodiments, filtered or unfiltered non-toxic waste can be vented from the blending machine to the environment, thereby reducing or eliminating the need for a waste port. Each cartridge includes a piston pump and valves that control the introduction, discharge, and fluid path selection of fluid during steps of the blending process as fluid moves through the cartridge and into the receiving container.

[0069] A turntable assembly 14 is mounted on the device, allowing it to rotate to align different tablet cartridges 16 with the pump drive mechanism 20. The turntable 14 is typically enclosed within a housing 12, which can be opened to replace the used turntable with a new one. As shown, the turntable 14 can hold up to 10 tablet cartridges 16, allowing a particular turntable to be used up to 10 times. In this configuration, each turntable assembly can support, for example, 10 to 100 receiving containers, depending on the type of compounding to be performed. For example, for hazardous drug compounding, the turntable assembly can support compounding up to ten receiving containers. In another example, for non-hazardous drug compounding, such as antibiotics or analgesics, the turntable assembly can support compounding up to 100 receiving containers. The housing 12 also includes a star wheel 22 positioned below the turntable 14. The star wheel 22 rotates the vials 18 of the medication to a position aligned with or separate from a specific tablet cartridge 16 on the turntable 14. The housing 12 may also include an opening 24 for loading the vial 18 onto the star wheel 22.

[0070] Each of the cartridges 16 in the turntable 14 is a disposable unit that includes multiple pathways for diluent and vapor waste. These pathways will refer to, for example... Figure 39 The following details are provided. Each cartridge 16 is a small, single-use unit that may also include a "backpack" in which tubing for connection to a receiving container (e.g., an IV bag, syringe, or elastic bag) can be held. Each cartridge 16 may also include a pumping mechanism (e.g., a piston pump for moving fluid and vapor through the cartridge 16) and a dual-chamber needle in the housing that can pierce the vial disc 26 above the vial 18 once the vial 18 has been moved into place by the pump drive mechanism 20. For example, the needle can pierce the vial disc 26 via compression action toward the needle-moving vial disc 26. Each cartridge 16 also includes multiple ports designed to mate with needles of multiple diluent manifolds. Each cartridge 16 also includes openings for receiving locking snap-fits and mounting posts from the pump head assembly 28. Although locking snap-fits are described herein as examples, other locking mechanisms may also be used to remove and lock the cartridge to the pump head (e.g., a clamp, forceps, or the like may extend from the pump head). Each cartridge 16 also includes an opening that allows a valve actuator from the pump motor mechanism to interact with a valve on each cartridge 16.

[0071] Adjacent to the housing 12 holding the vial 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 inlet port 34, and port 36 is an outlet port 36. Although this embodiment is sometimes discussed herein as an example, either port 34 or 36 can be implemented as an inlet and / or outlet port for the container 32. For example, in another embodiment, an inlet 34 for receiving a connector at the end of the 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 follows: Figure 1-3 The column shown has hooks. As discussed in further detail below, one or more of the hooks used to suspend containers such as diluent containers, receiving containers, or waste containers may be equipped with weight sensors, such as load elements, that detect and monitor the weight of the suspended container. The holding device 30 may be in any other form required for positioning the IV bag 32 or other drug containers. Once the IV bag 32 is positioned on the holding device 30, the first tube 38 (a portion of which is in...) Figure 1 (As shown in the diagram) the tube connects from the tablet cassette 16 on the turntable 14 to the inlet 34 of the IV bag 32. For example, the first tube can be housed in a backpack attached to the tablet cassette and extend from within the backpack (e.g., by an operator or automatically) to reach the IV bag 32. For example, a tube 38 may be provided at its end. Connector 37, etc., for connecting to the inlet 34 of the receiving container 32.

[0072] On the opposite side of the blending machine 10 is a holding device 40 for holding an array of multiple IV bags 32 or other containers. In the illustrated version of the blending machine 10, five IV bags 42, 44 are shown. Three of these bags 42 may contain a diluent, such as brine, D5W, or sterile water; however, any diluent known in the art may be used. Additional bags in the array may be empty vapor waste bags 44 for collecting waste, such as potentially hazardous or toxic vapor waste from the blending process. Additional bags 44 may be liquid waste bags. Liquid waste bags may be configured to receive non-toxic liquid waste, such as brine, from receiving containers. As discussed in more detail below, liquid waste can be pumped to the waste bags via dedicated tubing using a mechanical pump. In operation, the diluent lines and vapor waste lines from the corresponding containers 42 and 44 may each be connected to the cartridge 16 via disposable manifolds.

[0073] The compounding system 10 also includes a dedicated vial disc 26, designed to attach to various types of vials 18. In operation, the vial disc 26 is placed on top of the vial 18 containing the reagent to be reconstituted. Once the vial disc 26 is in place, the vial 18 is loaded into the star wheel 22 of the compounding machine 10. While the vial disc 26 is in the star wheel 22 and as it subsequently rotates into place, mating features on the vial disc 26 provide proper alignment, allowing the compounding machine 10 to remove it from the star wheel 22 for further processing.

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

[0075] The compounding system also includes a diluent cartridge, which is mounted in a slot 60 located on the side of the pump drive mechanism. The diluent cartridge can be a disposable component, configured to receive any number of individual diluent manifolds that can operate as diluent ports. The diluent manifolds can be modular, so they can be easily and removably connected to each other, the cartridge, 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 gripping arm 76, a vial lifter 78, a pump cartridge gripping section 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 medication in the vial 18 after the diluent has been added. The compounding machine 10 may also include an input screen 86, such as the touchscreen 86 shown in the figure, for user-provided data input and to provide notifications, instructions, and feedback to the user.

[0077] According to one embodiment, now in Figure 8The flowchart shown generally describes the operation of the blending machine system 10. In a first step 88, the user inserts a new diluent manifold cartridge containing multiple manifolds (e.g., diluent manifold and waste manifold) into a slot 60 on the side of the pump head assembly 28. The manifolds can be loaded into the cartridge before or after the cartridge is installed into the slot 60. The manifolds hold the needle within the manifold housing until the cartridge 16 is subsequently locked in place. The cartridge 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 tubing is connected to the corresponding diluent bag. The tubing can be routed through locking flanges on the surface of the blending machine housing (e.g., the front surface) to hold them in place. For example, in Figure 11 In the illustrated embodiment, the tube is held in place by a locking flange 2402 on the frame of the laminating machine. Alternatively, other types of clamps or locking mechanisms known in the art can be used to securely hold the tube in place. Figure 4 In the illustrated embodiment, 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 pipe can be connected to the vapor waste bag 44. In other embodiments, the pipe can be pre-connected between the manifold and the associated containers (such as diluent containers and / or waste containers), and steps 92 and 98 can be omitted.

[0078] If needed, in the next step 100, a new turntable 14 can be loaded into the turntable mounting platform, such as a turntable hub, of the reconstituted system. The turntable 14 may contain any number of disposable tablet cassettes 16 arranged in a generally circular array. In the next step 110, a vial disc 26 is attached to the top of a vial 18 for reconstituted powder or liquid medication, and in the next step 112, the vial 18 is loaded into a star wheel 22 below the turntable 14. Step 110 may include loading multiple vials 18 into multiple vial disc recesses in the star wheel 22. After one or more vials are loaded into the star wheel, the vials are rotated into position to allow and initiate scanning of the vial label for each vial. In one embodiment, the user is allowed to load vials into the star wheel until all vial slots are occupied before initiating scanning. Sensors may be provided that detect the loading of each vial and then rotate the next vial disc recess to the user's loading position. Allowing the user to load all vials into the star wheel before scanning the vial label helps improve the efficiency of compounding. However, in other embodiments, scanning of the vial label 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 to allow the user to select the appropriate dose on the input screen.

[0079] After selection on input screen 86, the compounding machine 10 begins operation 116. Star wheel 22 rotates the vial until it aligns 118 with the vial gripping clamp 76 of pump head assembly 28. Vial disc 26 includes, for example, gears that engage with gears coupled to a rotary motor, allowing 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 vial 18. The scanner or camera (and associated processing circuitry) can determine the vial's batch number and expiration date. The batch number and expiration date can be compared with other information (such as the current date and / or recall or other instructions associated with the batch number). Once vial 18 is scanned and aligned, in the next step 124, pump drive mechanism 20 moves forward into position to grip vial 18 with clamp 76. This forward movement also aligns the mounting post 130 and locking latch 128 on the front of pump head assembly 28 with corresponding openings on the tablet cassette 16. In the next step 126, the tablet cassette 16 is locked into place on the pump head assembly 28 by the locking latch 128, and the caliper 76 clamps the vial disc 26 on top of the vial 132. The caliper 76 then removes the vial 132 from the star wheel 22 by moving backward, while simultaneously pulling the tablet cassette 16 away from the turntable 14.

[0080] In some embodiments, the cartridge 16 includes a backpack containing a coiled tube. In this embodiment, in step 136, the pump drive mechanism 20 tilts the cartridge 16 toward the user to expose the end of the tube, and prompts 138 the user to pull the tube out of the backpack and connect it to the receiving bag 32. In an alternative embodiment, the tube 38 is exposed on the side of the turntable 14 after the cartridge 16 is pulled away from the turntable 14. In another alternative embodiment, the tube 38 is automatically pushed out (e.g., emerging from the backpack), allowing the user to grab it onto the connector located at the end of the tube and connect it to the receiving container. The system prompts 138 the user to pull the tube out of the turntable 14 and connect it to the inlet 34 of the IV bag 32. Once the tube 38 is connected, in step 140, the user can notify the recompactor 10 to continue the recompacting process by interacting with the input screen 86.

[0081] At step 142, the vial 18 is pulled up toward the tablet holder 16 so that one or more needles of the tablet holder 16, such as a coaxial double-lumen needle, pierce the top of the vial disc 26 and enter the interior of the vial 18. Although Figure 8 The example illustrates engagement of the needle with the vial disc after the user attaches the tube from the cassette to the receiving container, but this is merely illustrative. In another embodiment, steps 138 and 140 may be performed after step 142, such that engagement of the needle with the vial disc occurs before the user attaches the tube from the cassette to the receiving container.

[0082] At step 144, the diluent is delivered in an appropriate dose to the vial 18 via the tablet cartridge 16 and the first syringe pump. If necessary, a second or third diluent can be added to the vial 18 via a second or third diluent manifold attached to the tablet cartridge 16. Simultaneously, vapor waste exits the vial 18 through the second syringe pump 144, through the tablet cartridge 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 tablet cartridge 16 to change the fluid flow path as needed during the process. Once the diluent has been 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, causing the vial 18 to rotate between a face-up position and an inverted position. The shaking process can be repeated for the necessary time, depending on the type of drug to be reconstituted. Additionally, different shaking patterns can be used depending on the type of drug to be reconstituted. For example, for some medications, instead of rotating 180 degrees, a combination of forward and backward and left and right movements of the pump head can be performed to produce a swirling agitation of the vial. Multiple default agitation patterns for specific medications or other medical fluids can be included in a medication database stored in (and / or accessible by) the reconstituter control circuitry. Once the agitation step is complete, the pump drive mechanism rotates the vial to an inverted position or other suitable position and holds it in place. In some embodiments, fluids such as diluents already in receiving container 32 can be pumped (e.g., via a tablet cartridge or via a separate path) into a liquid waste container to make room in the receiving container for receiving reconstituted medications.

[0083] In the next step 148, valve actuator 84 reorients the valve of the tablet cartridge, and the pumping mechanism of tablet cartridge 16 is activated to pump the reconstituted medication 150 into the receiving bag 32 through the attached tubing. Once the medication has been pumped into the receiving bag 32, in the next step 152, pump drive mechanism 20, after another valve adjustment, cleans tube 38 by pumping filtered air or more diluent through tube 38 into the receiving bag 32 to ensure that all the reconstituted medication is provided to the receiving bag 32. In some scenarios, a syringe can be used as the receiving container 32. In scenarios where a syringe is used as the receiving container 32, after the reconstituted medication is delivered to the syringe, a vacuum can be created in tube 38 by pump drive mechanism 20 to remove any air or other vapors that may have been pushed into the syringe, so that when the syringe is removed from tube 38, the reconstituted medication is ready to be delivered to the patient, and there is no air or other unwanted gas in the syringe.

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

[0085] The cartridge 16 is designed for single use, allowing the user to use all cartridges 16 in a given turntable 14 before replacing the turntable 14. After a cartridge 16 is used, the turntable 14 rotates to the next cartridge 16, and the system software updates to indicate that the cartridge 16 has been used, thus preventing cross-contamination from other reconstituted reagents. Each cartridge 16 is designed to include all necessary flow paths, valves, filters, and pumps to reconstitute reagents with multiple diluents as needed, pump the reconstituted reagents to a receiving container, pump vapor waste out of the system to a waste container, and perform a final QS step to ensure that the appropriate amount of reagent and diluent is present in the receiving container. This complete kit is made possible by the specific and unique configuration of the cartridge 16, its flow paths, and its valve configuration.

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

[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 for receiving mounting posts 130 from the pump head assembly 28; and a keyhole 210 that allows a locking snap-fit ​​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 within a silicone piston shroud. Furthermore, the baffle 164 includes an opening 228 in which a valve 190 of the sealing diaphragm is located and accessed by a valve actuator 84. Additionally, the baffle 164 includes an opening 230 that allows fluid manifold connection to the diluent chamber and vapor waste chamber within the cartridge 16. As discussed in more detail below, the baffle 164 may also include an opening that facilitates detection of the connector when the user inserts it into the provided slot upon completion of mating (e.g., or (Connector). In operation, the needle of the fluid manifold enters and pierces the sealing membrane through the opening 230 in the baffle 164 to obtain fluid passages to the diluent chamber and vapor waste chamber defined in the cartridge 16 between the sealing membrane and the cartridge frame 160. Further details of various embodiments of the cartridge 16 will be discussed below.

[0088] refer to Figure 10 According to one embodiment, an exemplary embodiment of a turntable 14 removed from a compounding machine 10 is shown. Figure 10 In this embodiment, the turntable 14 includes an array of ten cartridges 16. However, it should be understood that more or fewer cartridges 16 may be present on the turntable 14, 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 cartridge recesses 500. In some embodiments, the turntable 14 may also optionally include a cover 511, which prevents the user from directly accessing the tubes connected to each of the cartridges 16. In these embodiments, the cover 511 can be removed if access to the back of the cartridges 16 is required. Figure 10 In an example implementation, the connector is, for example The attachment 548 is configured adjacent to each cartridge 16 and is attached to a tube 38 extending from an extension 220 on each cartridge 16.

[0089] Figure 11-14 A compounding machine 10 according to another embodiment is shown. For example... Figure 11As shown, retaining device 40 can be implemented as an extension arm that provides support for the mounting of each of containers 42 and 44. Retaining devices 40 and 30 can each include one or more sensors, such as weight sensors, configured to provide weight measurements to determine whether an appropriate amount of fluid has been added to or removed from the container, or to confirm that fluid is being delivered to and / or from the appropriate container (e.g., appropriate diluent is being dispensed). A scanner 2404 can be provided through which each diluent container and / or receiving container can be scanned before and / or after attachment to the reconstituter 10. Figure 11 As shown, in various embodiments, the turntable cover 2400 and the pipe management structure 2402 may also be provided on the blending machine 10. For example, the pipes connecting the containers 42 and / or 44 to their corresponding manifolds may each be installed in a groove in the pipe management structure 2402 to prevent the pipes from becoming tangled or caught during operation of the blending machine 10.

[0090] An opening may be provided through which the vial 18 can be installed 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 the required amount of brine out of the receiving container 32 without allowing the liquid waste to pass through the tablet cassette and / or other parts of the compounding machine).

[0091] A fluid module 2504 can be configured, comprising several container mounts for suspending diluent containers and waste containers, and may include sensor circuitry to sense when containers are suspended and / or sense their weight. This allows for monitoring of the operation of the blending machine 10 to ensure that the correct diluent containers are scanned and suspended in the correct positions, and to ensure that waste is supplied to the appropriate waste containers in the expected amounts.

[0092] like Figure 12 As shown, pump 2500 and display 86 can be mounted to rack 2600. Pump driver 20 can be partially mounted within rack 2600, and pump head assembly 28 extends from the rack to a position that allows the pump head assembly to rotate (e.g., flip or shake the vial). Figure 12 The diagram also shows a turntable 14 in which no disc cartridges are installed, so that the disc cartridge mounting recess 500 can be seen.

[0093] Star Wheel 22 (sometimes referred to as the vial tray in this article) in Figure 12The diagram shows a disc recess 2604 with several empty vials. The vial tray 22 is rotatable, and an actuation door 2608 can open to facilitate loading the vials 18 into the disc recesses 2604 within the vial tray 22. In some embodiments, the door 2608 can close before the vial tray 22 rotates to ensure that the operator's fingers are not at risk of injury from the rotating tray. However, this is merely illustrative. In other embodiments, a sensor, such as sensor 2650 (e.g., a light curtain), can be used instead of (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 can be provided for the turntable 14 to prevent contamination of the disc cassette 16 loaded therein and to prevent injury to the operator due to the rotation of the turntable. A cover sensor (not shown) can also be provided to detect the position of the cover (e.g., open or closed). If the cover sensor does not detect that the cover is in the closed position, rotation of the turntable 14 can be prevented.

[0095] Each inserted vial 18 can be detected using a sensor such as sensor 2652 (e.g., a load sensor or an optical sensor) when it is placed in the vial disc recess 2604. When detected, the inserted vial can be moved to the scanning position by rotating the vial tray 22, and then the inserted vial 18 can 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 compounding machine 10 Figure 13 As shown, a scanning component is visible. Specifically, a camera 2700 is mounted in an opening in a frame 2600 and configured to observe the vial 18 at a scanning position. A motor 2602 can rotate the vial 18 one or more full revolutions, allowing the camera 2700 to capture an image of the vial label. In some embodiments, an illumination device 2702 (e.g., a light-emitting diode or other light source) may be provided to illuminate the vial 18 for imaging by the camera 2700.

[0097] like Figure 13 As shown, one or more gears 2704 can be connected to the motor 2602, which mesh with corresponding gears on the vial disc 26 attached to the vial 18 at the scanning position. The vial tray 22 can be rotated so that the vial disc gear meshes with the rotary motor gear, causing the vial 18 to rotate when the motor 2602 is operated.

[0098] Figure 13The diagram also illustrates how a cartridge 2706 containing one or more manifolds can be mounted in a recess within the pump head assembly 28. A cartridge slot in cartridge 2706 for a vapor waste manifold can be keyed to prevent accidental connection of a diluent manifold to that slot (or accidental connection of a waste manifold to a diluent slot in the cartridge). Other diluent slots in cartridge 2706 can have a common geometry, allowing any diluent manifold to be fitted into the cartridge diluent slot. One or more manifold sensors, such as manifold sensors 2750 (e.g., optical sensors), can be disposed in manifold recesses within the pump head assembly 28. Manifold sensors 2750 can be configured to detect the presence (or absence) of a manifold in the manifold recess (slot) of cartridge 2706 to ensure that the appropriate manifold (e.g., a diluent manifold or waste manifold) is loaded at the intended location for reconstitution operations. In this way, the pump head can detect the presence of the manifold. The pump head and / or manifold sensors can communicate with a diluent load sensor to ensure 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 fix and operate the pump disc box 16.

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

[0100] Turntable 14 can be placed on a turntable hub and rotated by a vial tray plus turntable drive assembly that operates to rotate the hub to move selected tablet cartridges in the turntable into place for removal and operation by pump driver 20. The vial tray plus turntable drive assembly may include separate drive assemblies for the vial tray and for the turntable, allowing the vial tray 22 and turntable 14 to rotate independently.

[0101] Figure 14 Another perspective view of a compounding machine 10 according to one embodiment is shown, highlighting the positions of various specific components, such as the turntable 14 in which the tablet cassette 16 is mounted, the tablet cassette 16 having a backpack 2900, the vial disc 26 for holding vials 18, and the pump head assembly 28 having a diluent cartridge 2706 containing multiple manifolds 2906. Further features of the compounding machine 10 will be described below. Figure 15 Describe it, etc.

[0102] The tablet cartridge 16 is designed for single use, allowing the user to use all tablet cartridges 16 in a given turntable 14 before changing the turntable 14. After a tablet cartridge 16 is used, the turntable 14 rotates to the next tablet cartridge 16, and the system software updates to indicate that the tablet cartridge 16 has been used, thus preventing cross-contamination from other reconstituted reagents. Each tablet cartridge 16 is designed to include all necessary flow paths, valves, filters, pistons, and pumps to reconstitute the reagent with multiple diluents as needed, pump the reconstituted reagent to a receiving container, pump vapor waste out of the system to a waste container, and perform a final QS step to ensure that the appropriate amount of reagent and diluent is present in the receiving container. The amount of diluent pumped into vials for reconstitution and the amount of reagent pumped out of vials to the receiving container are controlled by the volumetric piston pump in the tablet cartridge, which can be compared with the weight obtained by the weighing scales of the reconstituter (e.g., one or more diluent loading elements and receiving container loading elements) for quality control. This complete kit is made possible by the specific and unique configuration of the cartridge 16, its flow path, and its valve configuration.

[0103] Various embodiments of the cartridge 16 in Figure 15-20B As shown in the figure. In one embodiment, the fully constructed cartridge 16 is in Figure 15 and 16 As shown in [the image]. Figure 17 and 18 The image shows a tablet cassette 16 having a tubular management structure implemented as a tablet holder in a backpack. According to one embodiment, an exploded version of the tablet cassette 16 is shown... Figure 19 The diagram shows, and illustrates, the three main components of the cassette 16: the cassette frame 160, the cassette sealing film 162, the cassette baffle 164, the piston pump 166, the needle housing 168, and the needle assembly 170. In one embodiment, the fully constructed cassette 16... Figure 20A and 20B Shown in. Figure 19 , 20A The various features of the 20B disc cartridge are as follows: Figure 21-31 Shown in.

[0104] like Figure 15 The diagram shows a front view of the tablet cartridge 16. The cartridge housing 160 provides primary support for each cartridge 16. A piston pump 166 and a cartridge needle housing 168 for holding the needle assembly 170 are provided, which can be operated during reconfiguration and filling of the receiving container 32 to move liquid and waste vapors toward and from the vial 18. A valve 190 is positioned relative to various internal flow paths within the cartridge 16 for diluent, vapor waste, filtered air, and reconfigured reagent, and is operable to modify and control these internal flow paths as needed.

[0105] The frame 160 of the tablet cartridge 16 also includes positioning features that allow each tablet cartridge 16 to be removably mounted to the pump head assembly 28. These features include: three openings 198 for receiving mounting posts 130 from the pump head assembly 28; and a keyhole 210 that allows a locking snap-fit ​​128 to be inserted therein and rotated to lock the tablet 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 engaging 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 user contact with the needle assembly 170 and to hold one or more needles of the needle assembly (e.g., see...). Figure 31 The sterility of needles 316 and 318. The needle housing 168 also receives the vial disc 26 in a certain position to allow the needle to puncture the vial disc 26.

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

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

[0109] For example, piston pumps such as piston pump 166, used as positive displacement pumps, offer significant advantages over traditional peristaltic pump mechanisms. First, they provide optimal rate accuracy and flow continuity regardless of pump orientation or environmental conditions. Second, they can deliver an excess of 50 psi into the resilient pump. Piston pump 166 can be positioned within a silicone piston pump housing within cartridge 16. The pump mechanism is driven by a motor in pump motor mechanism 20, which rotates drive pin 222 and eccentric drive shaft 82 on pump head assembly 28, which controls the movement of piston 166 and valve actuator 84. In operation, cartridge 16 is placed on cartridge gripper 80 located on post 130 and locked in place by locking clip 128. This aligns the valve in the opening 228 of baffle 164 with valve actuator 84, and aligns the eccentric drive shaft 82 and pin 222 with piston pump 166. Piston 166 is driven by eccentric drive pin 222. Pin 222 is parallel to but offset from the axis of rotation of the drive shaft, which produces a sinusoidal motion, which is converted into axial movement of piston 166.

[0110] Valve actuator 84 Figure 6 and 7The diagram shows the pump head assembly 28 removed from the rest of the pump motor mechanism 20. Each valve in the opening 228 has a corresponding valve actuator 84 controlled by a gear cam to move axially to contact the valve to close it and away from it to open it. In one embodiment, eight valve actuators 84 are provided, one for each valve, and they are aligned with the valve's position so that they can extend through the opening 228 in the baffle 164 of the cartridge 16 and contact the valve. The valve actuators 84 are software-controlled so that they can automatically open and close the valve based on which internal flow paths within the cartridge 16 are to be opened and closed.

[0111] Valve actuator 84 is operated at different times during the pumping cycle according to the desired fluid flow path. The charging portion of piston 166 begins as piston rod 194 moves, and the inlet valve opens while the outlet valve closes. Other valves open and close according to the desired fluid flow path. At the end of the charging portion of the cycle, when piston 166 is at bottom dead center, the valve actuation changes to close the inlet and open the outlet valve. At this point, the delivery portion of the cycle begins, and piston 166 moves in the opposite direction. The delivery portion of the cycle ends when piston 166 reaches top dead center (the starting position). A new cycle begins when piston 166 reaches this position.

[0112] The eccentric drive shaft 82 moves clockwise when conveying fluid under normal conditions and counterclockwise when pumping fluid. Depending on the desired flow path, the pump mechanism can be reversed for pumping. Pressure up to 50 psi in the primary pipeline prevents the drive from being unintentionally reversed in either direction.

[0113] exist Figure 17 and 18 An alternative embodiment of the cartridge 16 employing a "backpack" to coil the flexible tube 38 is shown. The backpack 298 is attached to the back of the cartridge frame 160, and one end of the flexible tube 38 is attached to an outlet port on the back of the cartridge frame 16. The backpack 298 includes a housing 310 and may include a tube control mechanism defined in a chamber, which is rotatable or otherwise operable 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...). An attachment (which can be pulled out of the backpack 298 and attached to the receiving pouch 32 by the user). In some embodiments, a tube attached to the connector 300 can automatically extend from within the backpack 298 to facilitate attachment by the user. After the pouch 32 is filled, a tube control mechanism can pull the flexible tube 38 back into the backpack 298 without obstructing access, allowing the next cassette 16 in the turntable 14 to be used. The retraction of the flexible tube can be automatic once the ISO Luer is placed into the opening in the backpack.

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

[0115] To control the flow of gases (such as vapor waste and sterile air) within the cartridge, cartridge 16 may be equipped 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 check valve covers 3002. The air filter 3006, check valve discs 3004, and check valve covers 3002 can operate collaboratively to allow vapor waste to flow in only one direction from the vial to the waste port, and to allow sterile (filtered) air to flow in only one direction into the cartridge from the vent of the adjacent air filter to the vial. In this way, non-vapor waste can be prevented from flowing out of the pump cartridge and can instead be directed to the vapor waste container.

[0116] like Figure 19 As shown, piston 166 may include piston shroud 3007, which, for example, provides one or more movable seals (e.g., two movable seals) for controlling the volume of the pump chamber when piston 166 is actuated. Figure 19 Various configurations for controlling the needle housing 168 are also shown, wherein the needle assembly 170 includes a dual-lumen needle having a first needle overlay 317A, a second needle overlay 317B, a needle spring 3014, and a needle diaphragm 3008. An opening 3020 in the baffle 164 may be provided aligned with a corresponding opening 3021 in the frame 160 to allow observation through the cassette 16 into the backpack fitted 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 may be provided as a mounting structure for the backpack.

[0117] Figure 20A and 20B Shown from the baffle side and the frame side respectively Figure 19 An assembly view of the cartridge embodiment shown, in which opening 3120 can be seen (by... Figure 19 The openings 3020 and 3021 are formed, which allow observation completely through the slide cassette 16. Figure 20AAs shown, in some embodiments, cartridge 16 may include four diluent and waste ports 3100 and a pressure dome 3101. For example, three of the ports 3100 may be configured as diluent ports, while one of the ports 3100 may be configured as a waste port. A pressure sensor in pump head assembly 28 may determine the pressure within the fluid passage in cartridge 16 by contacting the pressure dome 3101. Each of the ports 3100 may be formed by an opening in baffle 164 and a chamber located downstream of a portion of membrane 162 in housing 160.

[0118] Figure 21 This is a cross-sectional perspective side view of the assembled lens cartridge 16, which has a backpack 3202 attached thereto (e.g., Figure 14 (One embodiment of the backpack 2900) is used to form a cassette plus backpack assembly 3203. For example... Figure 21 As shown, a protrusion 3016 may extend into an opening 3201 in the backpack 3202 to latch the backpack to the cassette 16 on the top side. An additional latching structure on the bottom side will be described in more detail below. An additional structure 3200 may be disposed between the backpack 3202 and the cassette 16. Structure 3200 may be generally flat and may be shaped and positioned to latch the cassette plus backpack assembly 3203 to the turntable 14. For example, a protrusion 3206 extending from the top of the backpack 3202 may be actuable to facilitate the installation and removal of the cassette plus backpack assembly from and from the turntable. For example, a ramp structure on the turntable may compress the protrusion 3206 as the cassette plus backpack assembly 3203 is pushed into the turntable until the protrusion 3206 engages upward into a locking position to secure the cassette plus backpack assembly in the turntable. To remove the cartridge and backpack assembly 3203 from the turntable for re-fitting operations, the snap-fit ​​member 128 extending into the opening 210 can be rotated to lower the protrusion 3206, thereby releasing the cartridge and backpack assembly from the turntable. Further features of attaching the cartridge and backpack assembly 3203 to the turntable will be described below.

[0119] A tube (e.g., flexible tube 38) for fluidly connecting the cartridge 16 to the receiving container 32 can be housed within the backpack 3202. For example, the tube can be located at the output port 180 (e.g., the receiving container port, see example). Figure 20B The tube is attached to the cartridge 16, coiled within the internal cavity of the backpack 3202, and extends through the opening 3210, allowing the operator to pull one end of the tube to extend it for attachment to the receiving container. An additional opening 3204 may be provided to store connectors attached to the end of the tube, such as..., when the cartridge and backpack assembly are not in use. Connector. When instructed (e.g., via 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 circuitry of the compounding system can use a display to provide instructions to: (a) remove the connector attached to the tube from an additional opening in the backpack, (b) pull the tube out of the backpack, and (c) connect said connector to the receiving container. In another embodiment, the extension of the flexible tube is automatic (e.g., software determines the precise moment when the flexible tube should be extended, a pump head operates a helical mechanism to extend the tube, and provides a signal to the user to pull the ISO Luer out of the backpack opening). Compounding machine 10 may include sensors, such as optical sensors, that determine the presence of the connector within opening 3204 (e.g., by observing the connector through opening 3120).

[0120] The refitting machine 10 can determine whether and when to release the cartridge plus bag assembly from the pump head assembly based on whether the connector is within the opening 3204. For example, after a refitting operation, the operator can be instructed to remove the connector from the receiving container and return the connector to the opening 3204. The bag 3202 may include features and components for facilitating the storage and retrieval of the tube from its internal cavity. When the connector is detected to be within the opening 3204, the pump drive mechanism 20 can operate one or more coiling mechanisms within the bag 3202 to pull the extended tube back into the bag, and can rotate the snap-fit ​​member to lower the protrusion 3206, allowing the cartridge plus bag assembly to return to the turntable.

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

[0122] Figure 22This is a cross-sectional side view showing the disc cartridge of the piston pump 166. (See attached image.) Figure 22 As shown, 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 the 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 located on opposite sides of the pump chamber to control the flow of fluid into and out of the pump chamber).

[0123] exist Figure 23 For the purposes of this discussion, valve 190 is designated as one of three valve groups V1, V2, and V3. Valve group V1 may be a diluent valve group with three valves P1, P2, and P3. Valve group V2 may be a reconfigurable valve group with three valves P1, P2, and P3. The piston pump valves P1 and P2 of valve group V3 (e.g., a piston pump valve group) may be operated alternately in cooperation with piston pump 166. For example, during the forward stroke of piston pump 166, valve V3 / P1 may be closed and valve V3 / P2 may be open, and during the reverse stroke of piston pump 166, valve V3 / P1 may be open and valve V3 / P2 may be closed to pump fluid in the fluid passage of cartridge 16 in a first direction. In another example, in order to pump fluid in the fluid passage of cartridge 16 in the opposite second direction, valve V3 / P1 can be opened and valve V3 / P2 can be closed during the forward stroke of piston pump 166, and valve V3 / P1 can be closed and valve V3 / P2 can be opened during the reverse stroke of piston pump 166.

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

[0125] exist Figure 25In the example, the valves of valve groups V1 and V2 are configured to pump diluent from the diluent container to the vial for a reconfiguration operation (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 7400 from one of the diluent ports 3100 to the vial port 7402). As shown, during the reconfiguration 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 may be associated with air filter check valve structures 3004, 3004 and 3006, which prevent any vapor waste from flowing along path 7408 and ensure that all vapor waste from vial 18 moves along path 7404 through waste port 3100.

[0126] exist Figure 26 In the example, the valves of valve groups V1 and V2 are configured to pump the reconstituted medication from the vial to the receiving container for a reconstitution operation (e.g., valves P1 and P2 of group V1 are closed, valve P3 of group V1 is open, valves P1 and P2 of group V2 are closed, and valve P3 of group V2 is open, forming a fluid path 7500 from vial port 7402 to receiving container port 7302). As shown, during the reconstitution operation, path 7502 can be configured from air filter port 7410 to non-hazardous vapor vial port 7405 to provide filtered sterile air from outside the tablet cartridge 16 into the vial to prevent vacuum from forming when the medication is pumped from the vial.

[0127] Although receiving container 32 is, for example Figure 1 , 3 As shown in Figure 11 as an IV bag, in some scenarios, the receiving container 32 can be implemented as a syringe. For example, it can be connected to an output port (such as receiving container port 7302) via a tube. The connector can be connected to a needleless valve connector (e.g.) Connector), The connector is attached to another needleless valve connector via an additional tube (e.g., another...). A connector that connects to a syringe used to receive the reconstituted medication. In scenarios where the receiving container is a syringe, it may be desirable to remove air or other vapors from the syringe after the medication has been pumped from the vial into the syringe.

[0128] exist Figure 27In the example, 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 may be alternately opened and closed in cooperation with the movement of piston pump 166 to move a desired fluid or vapor along the fluid passage defined by valve 190.

[0129] Figure 28 It is a chart that shows, for example Figure 23 Valve 190 marked in the middle is combined as described above. Figure 24-27 The location and operation during each part of the described reconstruction / recombination process.

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

[0131] When the manifold membrane is sealed, for example Figure 29B When the sealing manifold membrane 8252 of manifold 8250 is compressed, the portion of sealing membrane 162 forming the diluent and / or waste port 3100 establishes a drip-free connection between manifold 8250 and the cartridge. The manifold needle 8254 of the selected diluent manifold 8250 and the manifold needle of the waste manifold may extend through the corresponding manifold membrane 8252 and sealing membrane 162 in the respective diluent and waste ports to form fluid paths for diluent and waste vapors through sealing membrane 162 (e.g., through openings 8256, central bore 8257, and openings 8258 of needle 8254) for reconfiguration and repackaging operations.

[0132] However, Figure 29AThe example (where the seals for ports 3100D and 3100W are formed only by a portion of the opening in the baffle 164 extending from the membrane 162) is merely illustrative. In some embodiments, to provide an improved drip-free seal, the seal for 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 cartridge 16.

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

[0134] like Figure 29C As shown, the outer sealing member 8262 may include a portion extending through the opening 8260 and may also include a recess 8268 on its inner surface adjacent to the membrane 162. The membrane 162 may also include a recess 8266 on its inner surface adjacent to the inner sealing member 8264. Providing multiple sealing members, such as three sealing members (i.e., the portion of member 8262, member 8264, and membrane 162 formed between members 8262 and 8264) to the port 3100 can provide enhanced wiping of the needle 8254, thereby providing improved dry disconnection compared to embodiments 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 the recesses 8266 and 8268 can further improve the wiping efficiency of the needle 8254; however, in various embodiments, the sealing members may be provided with or without the recesses 8266 and / or 8268.

[0135] Figure 29D It shows Figure 29B The manifold 8250, and the manifold sealing member 8252 presses against it. Figure 29C The external sealing component 8262 of port 3100. For example... Figure 29D As shown, needle 8254 extends from manifold 8250 through sealing members 8252 and 8262, through gap space 8268, through membrane 162, through gap space 8266, and through inner sealing member 8264, such that openings 8256 and 8258 and central bore 8257 form a fluid passage between cassette 16 and manifold 8250.

[0136] exist Figure 29A In the example, a portion of the membrane 162 in the opening of the baffle 164 extending to the port 3100 can be compressed (e.g., compressed radially by 10%) to produce a wiping effect on the diluent needle extending through and thus out, such that when the diluent needle retracts into the manifold, no liquid remains on the diluent needle or the outer surface of the cassette or membrane.

[0137] exist Figure 29C and 29D In the example, a portion of the sealing member 8262 in the opening of the baffle 164 extending to the port 3100 can be compressed (e.g., compressed radially by 10%) to produce a wiping effect on the diluent needle extending through and thus out, such that when the diluent needle retracts into the manifold, no liquid remains on the diluent needle or the outer surface of the cassette or membrane. Figure 29C and 29D The multiple sealing components can be configured to each provide a wiping effect on the needle 8254, which complements the wiping effect of other sealing components (e.g., by providing peak wiping force to the needle at angularly spaced locations for each component relative to the other components).

[0138] Figure 30 This is a cross-sectional perspective side view of the film cassette and backpack assembly 3203, showing that protrusions 3016 and 3304 of the film cassette frame 160 cooperate to attach the film cassette 16 to the backpack 3202 to form the film cassette and backpack assembly 3203. To mount the backpack 3202 onto the film cassette 16, the opening 3201 of the backpack 3202 is positioned above the protrusion 3016, and the backpack 3202 can be rotated (e.g., along direction 3401) to push the latching feature 3302 of the backpack 3202 against the latching protrusion 3304 until the latching protrusion 3304 engages between the latching features 3302. As shown, the protrusion 3016 may be formed on an additional latching structure, such as a flexible arm 3400, of the film cassette 16. When the backpack 3202 is rotated to press the latch feature 3302 against the protrusion 3304, the flexible arm 3400 can allow the backpack 3202 to be pulled down a short distance. The flexible arm 3400 can be elastic to maintain an upward force, holding the latch feature 3302 in the latched position against the protrusion 3304.

[0139] exist Figure 30In the example, vial 18 and vial disc 26 are positioned adjacent to the cassette plus backpack assembly 3203, and needle assembly 170 extends into the vial through sealing member 3402 of cassette 16 and sealing member 3404 of vial disc 26, which can provide a drip-free seal and allow fluid to be supplied to and / or removed from vial 18. Sealing member 3402 may be an embodiment such as sealing member 3008. As shown, when needle assembly 170 extends into the vial, portions of vial disc 26 may be positioned adjacent to latching feature 3302 of backpack 3202.

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

[0141] Dual-chamber needles 316 and 318 may each be provided with openings 8400 and 8402, respectively, providing a fluid passage to the central bore of the needle. Needle 316 may be, for example, a size 24 needle held in a tablet cartridge frame 160 by a high-density polyethylene (HDPE) coating 317A, having an opening 8400 for discharging the vial. Opening 8400 may be formed using a slot cut as shown to reduce core removal from the sealing membrane during needle insertion and retraction. Needle 318 may be, for example, a size 18 needle held in a tablet cartridge frame by a high-density polyethylene (HDPE) coating 317B, having one or more openings 8402 for fluid inflow and / or outflow from the vial. Opening 8402 may include two bores configured to reduce core removal and allow fluid flow rates up to, for example, 60 mL / min.

[0142] Thus, during the reconstitution operation, the diluent can be supplied to the vial through the opening 8402 of needle 318, and vapor waste can be simultaneously removed from the vial through the opening 8400 of needle 316. During the compounding operation, the reconstituted reagent can be withdrawn from the vial through the opening 8402 of needle 318, and sterile air can be supplied to the vial through the opening 8400 of needle 316.

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

[0144] The embodiment of the cartridge 16 with a rotary piston pump / valve can reduce the component cost and complexity of the cartridge 16 because the same device can be used as both a pump and a shut-off valve. For example, in the rotary piston pump / valve, the rotary piston pump / valve acts as a pump when rotating, and when the rotary piston pump / valve stops rotating, it effectively acts as a shut-off valve, thereby preventing any fluid flow. Compared to other embodiments, the cartridge implemented with a rotary piston pump / valve can also use reduced power to rotate the motor for the rotary piston pump / valve (e.g., a simple stepper or DC motor). The embodiment of the cartridge 16 with a rotary piston pump / valve can provide other benefits, including preventing the diluent line from being exposed to pressure and preventing the waste line from being exposed to vacuum.

[0145] Figure 32 An illustrative embodiment of a rotary piston pump / valve is shown. (As...) Figure 32 As shown, 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 rotation of the pump head assembly rotates the gear and thereby rotates the cavity 13206. The gear 13202 may have a cam surface. The housing 13201 may include an input port 13208 and an output port 13210.

[0146] like Figure 32 As shown, when gear 13202 and rotary piston 13204 rotate and are positioned such that cavity 13206 is adjacent to input port 13208, fluid (e.g., diluent, waste fluid, or reconstituted agent) is drawn into cavity 13206 via a cam action on gear 13202, which actuates piston 13204 and cavity 13206 downward during the induction stroke. Figure 33As shown, after the initial stroke, gear 13202 and rotary piston 13204 rotate to a transition position with fluid present within cavity 13206, in which cavity 13206 is rotatably positioned between input port 13208 and output port 13210. Figure 34 As shown, after the transition, gear 13202 and rotary piston 13204 rotate to a position with fluid disposed within cavity 13206, at which cavity 13206 is rotatably aligned with output port 13210, such that fluid within cavity 13206 is ejected through output port 13210 by a cam action on gear 13202, which actuates piston 13204 and cavity 13206 upward during the ejection stroke.

[0147] Figure 35 A front view of a cartridge 16 in one embodiment is shown, wherein the cartridge is provided with a series of rotary piston pumps / valve 13200 actuated by a compounding machine. For example... Figure 35 As shown, the tablet cartridge 16 may include up to five rotary piston pumps / valve 13200, each disposed within an associated fluid passage of the tablet cartridge 16 to allow fluid to move or be prevented from moving through the associated fluid passage. The rotary piston pumps / valve 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 in / output port 13504 to the output port 13506 or from the output port 13506, from the output port 13506 or the syringe in / 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 tablet cartridge 16, depending on the operation of the compounding machine.

[0148] As described above Figures 32-34 As described, when each rotary piston pump / valve 13200 in cartridge 16 rotates, a piston undergoes a downward translational movement, drawing fluid from a portion of the associated fluid passage in cartridge 16 into the rotary piston pump / valve 13200. As the rotary piston continues to rotate, a cam action forces the piston upward, compelling fluid in the chamber to pass through the output port to another portion of the associated fluid passage in cartridge 16. The unique feature of this rotary piston pump / valve is that when the rotational motion stops, it prevents fluid flow through the rotary piston pump / valve, thus effectively functioning as a shut-off valve.

[0149] In some embodiments, instead of (or supplementing) the linear oscillating piston pump and / or rotary piston pump with a finger valve as described above, the cartridge 16 may be provided with a syringe pump with a syringe valve. Figure 36An example of a syringe pump / syringe valve device is shown, which can be provided to control the movement of fluid and / or gas through cartridge 16. Figure 36 As shown, 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 fluid flow through the device 13600, as well as the inlet and outlet 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 a corresponding port 13608. Figure 36 In the example, four of the five syringe valves 13602 are closed, and one syringe valve plunger is raised to create a cavity 13610 that forms a passage to the corresponding port 13608.

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

[0151] Figures 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. Figure 39 and 40 The example illustrates valve and piston operation used for reconfiguration. Figure 39 In the example, the plunger of syringe piston 13604 rises, while syringe valve 13602, connected to the diluent bag, opens to draw diluent into the syringe piston. Figure 40 In the example, syringe valve 13602 connected to the diluent bag is closed, syringe valve 13602 connected to the vial 18 is open, and the plunger of syringe piston 13604 descends to push the diluent into the vial. Figure 40 As shown, device 13600 may include redundant check valves 14000 and 14002 to prevent unnecessary flow (e.g., from a waste container or to a diluent bag).

[0152] Figure 41 and 42 The example illustrates valve and piston operation for compounding operations. Figure 41In the example, the plunger of syringe piston 13604 rises, while syringe valve 13602, connected to vial 18, opens to draw the reconstituted medication from the vial into the syringe piston. Figure 42 In the example, syringe valve 13602 connected to vial 18 is closed, syringe valve 13602 connected to receiving container 32 (e.g., dose bag) is open, and the plunger of syringe piston 13604 is lowered to push the reconstituted drug therein into the receiving container.

[0153] Figure 43 and 44 The example illustrates the valve and piston operation used for air purging. Figure 43 In the example, the plunger of syringe piston 13604 rises while syringe valve 13602, connected to an air filter (e.g., an air filter between the ambient air port and device 13600), opens to draw filtered air from the environment into the syringe piston. Figure 44 In the example, the syringe valve 13602 connected to the air filter is closed, the syringe valve 13602 connected to the receiving container 32 (e.g., a dosing bag) is open, and the plunger of the syringe piston 13604 drops to push the filtered air therein toward the receiving container (e.g., via a tube such as a "pigtail" tube between the tablet cassette 16 and the receiving container).

[0154] Figure 45 and 46 The example illustrates valve and piston operation for vacuum operation. Figure 45 In the example, the plunger of syringe piston 13604 rises, while syringe valve 13602, connected to receiving container 32, opens to draw waste gas from the receiving container into the syringe piston. Figure 46 In the example, the syringe valve 13602 connected to the receiving container is closed, the syringe valve 13602 connected to the waste container 44 is open, and the plunger of the syringe piston 13604 is lowered to push the waste gas therein into the waste container. Figure 47 A device 13600 is shown coupled to a tablet cartridge 16 at a certain position, wherein the syringe plunger of the syringe pump and syringe piston can be operated by a pump head assembly to control the flow of fluid and gas through the tablet cartridge 16 (e.g., as described above). Figures 39-46 (As described).

[0155] exist Figures 36-47 In the example, 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. Syringe-type valves can be used to obtain reliability and simplicity. As combined above Figures 39-46As described, each of the different processes in the compounding machine 10 can be assigned to a syringe valve, and in many cases, only one syringe valve will be open at any given 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 close, and the vial syringe valve will open. Once the vial syringe valve is open, the syringe pump will push the diluent fluid into the vial. Similar processes of syringe pump and valve operation can be repeated for all the different processes in the compounding machine 10.

[0156] In some embodiments, instead of (or supplementing) the linear oscillating piston pump, rotary piston pump, or syringe piston pump / valve device with a finger valve as described above, cartridge 16 may be provided with a syringe pump and one or more rotary valves. Figure 48 An example of a syringe pump / rotary valve device is shown, which can be provided to control the movement of fluid and / or gas through cartridge 16. Figure 48 As shown, the syringe pump / rotary valve device 14800 may include a syringe pump 14802 with an actuable plunger 14804 and a valve group 14806 with output ports 14808. Each output port 14808 may be selectively fluidly coupled (via operation of valves within the valve group 14806) to a chamber within the syringe pump 14802.

[0157] Figure 49 A front perspective view of a syringe pump / rotary valve device 14800 is shown, with its housing partially transparent, allowing the view of the seal 14902 on the plunger 14804, the internal fluid passage 14904, and the internal valve features of the rotary valve 14900 in the valve group 14806. As shown, the fluid passage 14904 fluidly connects the chamber of the syringe pump 14802 to the rotary valve 14900, each of which can be rotated by the pump head assembly during actuation of the plunger 14804 to connect the passage 14904 to the port 14808. Figure 50 A front perspective view of a syringe pump / rotary valve device 14800 with an opaque housing is shown, with a valve handle 15000 protruding through the opaque housing to allow rotational operation of the valve 14900 via a pump head assembly. Figure 51 A syringe pump / rotary valve device 14800 is shown connected in a certain position to a cartridge 16, wherein the syringe plunger of the syringe piston rotary valve 14900 can be operated by a pump head assembly to control the flow of fluid and gas through the cartridge 16.

[0158] Figure 52 A perspective view of one embodiment of a rotary valve 14900, in which the rotary valve is implemented as a plug rotary valve, is shown. Figure 52As shown, the rotary valve 14900 includes an opening 15204 disposed around the periphery of a cylindrical internal valve member 15202 rotatable by a valve handle 15000. Rotating the valve handle 15000 rotates the position of the opening 15204 relative to the fluid passage 15206 of the device 14800 to open and close the valve.

[0159] exist Figures 48-52 In the example, cartridge 16 has a large syringe-style pump, and the valves used to control the various processes are rotary stopcock-style valves. Rotary valves are used to achieve their reliability and ease of use. Each of the different processes performed by the compounding machine 10 can be performed using a designated rotary valve, and in many scenarios, only one rotary valve will be open at any given time. For example, during the reconstitution process, when the syringe pump draws fluid into the syringe pump, the rotary valve controlling the fluid passage to the diluent bag will be opened. Once the syringe pump chamber is full, the diluent bag valve will close, and the vial rotary valve will open. Once the vial rotary valve is open, the syringe pump will push the diluent fluid into the vial. The similar process of syringe pump and rotary valve operation can be repeated for all the 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 latching mechanism operated by the pump head assembly. However, a stepper or DC motor can be used to operate the positive latching mechanism, such as the snap-fit, to actuate the latching 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...). Figure 53 ), so that the cartridge 16 can be electromagnetically attached to the pump head assembly 28.

[0161] Magnet 15300 can be an active or passive magnet configured to temporarily attach the cartridge to the reassembly arm. Magnet 15300 can be mounted on the arm face of the reassembly machine at a position corresponding to a corresponding metal plate or other ferromagnetic component attached to the cartridge 16. When the cartridge 16 moves toward the arm face, the magnet is activated to attract and attach the cartridge to the arm face. The magnet can be deactivated when the cartridge is to be returned to the turntable (e.g., after the cartridge has been aligned with the turntable). Magnetic coupling can be used independently or in conjunction with a positive mechanical latching mechanism.

[0162] This article combines, for example Figure 32-53The various features described can be used individually or in combination with each other and / or in combination with the features described in Figures 1-31 to help provide simple high-flow-rate fluid paths and / or simple rotary valves; to facilitate the reduction or elimination of the need for filling and / or air flushing, such as "pigtail" tubing; to help provide flow paths that facilitate easy leak detection during production; to provide slow-motion syringe pumps that help reduce or eliminate foaming and / or damage to the medication; to facilitate the use of shared tablet cartridges for micro- and routine dosing; to help reduce the interaction between the pump head assembly (pump arm) and the tablet cartridge; to help facilitate the use of single-dose waste containers; to help facilitate the use of individual vial needles; to provide individual, independent valve control for flexibility in the control process; to facilitate the use of in-line air sensors in tubing leading to the receiving container, such as "pigtail" tubing; and / or to facilitate the use of... Figure 1-31 The described and / or part of the features in the existing system reduce tolerances.

[0163] This disclosure is provided to allow any person skilled in the art to implement the various aspects described herein. This disclosure provides various examples of the technology, and the 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 applied to other aspects.

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

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

[0166] The tablet cartridge has the following features:

[0167] Multiple controllable fluid paths fluidly connected to at least one diluent port, a waste port, and a receiving container port; and

[0168] A rotary piston pump / valve, which can rotate to control the movement of fluid through at least one of the controllable fluid passages.

[0169] Concept 2. The compounding system as described in Concept 1 or any other concept further includes at least one additional rotary piston pump / valve, which is rotatable to control the movement of another fluid through at least one of the controllable fluid passages.

[0170] Concept 3. A compounding machine system as described in Concept 1 or any other concept, wherein the rotary piston pump / valve includes a gear coupled to a rotary piston having a cavity.

[0171] Concept 4. A compounding machine system as described in Concept 3 or any other concept, wherein the rotary piston pump / valve further includes a cam surface for linearly actuating the rotary piston during rotation of the rotary piston via the gear.

[0172] Concept 5. A compounding machine system as described in Concept 4 or any other concept, wherein the rotary piston pump / valve further includes a housing in which a rotary piston is disposed, the housing having an input port and an output port.

[0173] Concept 6. A compounding machine system as described in Concept 5 or any other concept, wherein the rotary piston is configured to be linearly actuated in a first direction due to the action of a cam on the cam surface as the rotary piston rotates away from a first position, in which the cavity of the rotary piston is rotatably aligned with the input port.

[0174] Concept 7. A compounding machine system as described in Concept 6 or any other concept, wherein the rotary piston is further configured to rotate from the first position to a second position, in which the cavity is rotatably aligned with the output port.

[0175] Concept 8. A compounding machine system as described in Concept 7 or any other concept, wherein the rotary piston is further configured to be linearly actuated in a second direction due to the action of an additional cam on the cam surface as the rotary piston rotates from the first position to the second position.

[0176] Concept 9. A compounding machine system as described in Concept 8 or any other concept, wherein the rotary piston is further configured to stop rotating to prevent fluid flow between the input port and the output port.

[0177] Concept 10. A chip cassette for a multiprocessor system, the chip cassette comprising:

[0178] The first fluid passage extends from the diluent port to the vial connector; and

[0179] A first rotary piston pump / valve, disposed in the first fluid passage, is rotatable to control the movement of diluent from the diluent port to the vial connector, and is configured to stop rotating to prevent movement of diluent within the first fluid passage.

[0180] Concept 11. The cartridge as described in Concept 10 or any other concept further includes:

[0181] A second fluid passage, which is associated with the waste port; and

[0182] A second rotary piston pump / valve, disposed in the second fluid passage, is rotatable to control the movement of waste fluid or waste gas toward the waste port, and is configured to stop rotating to prevent the movement of waste fluid and waste gas within the second fluid passage.

[0183] Concept 12. The cartridge as described in Concept 11 or any other concept further includes:

[0184] A third fluid passage extends from the vial connector to the output port; and

[0185] A third rotary piston pump / valve, disposed in the third fluid passage, is rotatable to control the movement of the drug toward the output port, and is configured to stop rotating to prevent the movement of fluid within the third fluid passage.

[0186] Concept 13. A cartridge as described in Concept 12 or any other concept, wherein, while the first rotary piston pump / valve rotates to pump diluent from the diluent port through the first fluid passage to the vial connector, and while the second rotary piston pump / valve rotates to pump air from the vial connector to the waste port, the third rotary piston pump / valve is configured to function as a shut-off valve for the output port.

[0187] Concept 14. A tablet cartridge as described in Concept 13 or any other concept, wherein, while the third rotary piston pump / valve rotates to pump the drug from the vial connector through the third fluid passage to the output port, the first rotary piston pump / valve is configured to function as a shut-off valve for the diluent port.

[0188] Concept 15. A cartridge as described in Concept 12 or any other concept, wherein each of the first, second, and third rotary piston pumps / valve includes a rotary piston coupled to a gear for rotating the rotary piston.

[0189] Concept 16. A cartridge as described in Concept 15 or any other concept, wherein the rotary piston of each of the first, second, and third rotary piston pumps / valve is configured to rotate about an axis and translate in a direction perpendicular to the axis when rotated using a gear coupled to the rotary piston.

[0190] Concept 17. A cartridge as described in Concept 10 or any other concept, wherein the vial connector is a pin-type or pinless connector.

[0191] Concept 18. A compounding machine system, comprising:

[0192] The tablet cartridge has the following features:

[0193] Multiple controllable fluid paths fluidly connected to at least one diluent port, a waste port, and a receiving container port; and

[0194] At least one ferromagnetic component; and

[0195] Pump head assembly, which has:

[0196] At least one mechanism operable to control the flow of fluid through the plurality of controllable fluid passages, and

[0197] A magnet configured to attach the cartridge to the pump head assembly using the at least one ferromagnetic component.

[0198] Concept 19. A compounding machine system as described in Concept 18 or any other concept, wherein the magnet is an active magnet, and wherein the compounding machine system includes circuitry configured to activate the magnet as the cartridge moves toward the pump head assembly to attract and hold the cartridge to the pump head assembly.

[0199] Concept 20. A compounding machine system as described in Concept 19 or any other concept, wherein the circuitry is further configured to deactivate the magnet after a compounding operation using the mechanism of the cartridge and the pump head assembly, so as to release the cartridge from the pump head assembly.

[0200] One or more aspects or features of the subject matter described herein can 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 in which one or more processors are embedded or coupled. 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, buses, processing units, system memory, read-only memory (ROM), permanent storage devices, input device interfaces, output device interfaces, and network interfaces.

[0201] A bus can represent all system, peripheral, and chipset buses that communicatively connect numerous internal devices of the infusion pump system's electronics. For example, a bus can communicatively connect a processing unit to ROM, system memory, and permanent storage devices. From these various storage units, the processing unit can retrieve instructions to be executed and data to be processed in order to perform various processes. In different implementations, the processing unit can be a single processor or a multi-core processor.

[0202] Referring to an element in the singular does not imply "one and only one," unless specifically stated otherwise, but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Pronouns for the masculine (e.g., his) include those for the feminine and neutral genders (e.g., her and its), and vice versa. Titles and subtitles (if any) are for convenience only and do not limit the invention.

[0203] The term "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 respect, various alternative constructions and operations described herein may be considered at least equivalent.

[0204] As used herein, the phrase "at least one of" following a series of items (each separated by the term "or") modifies the list as a whole, not each item in the list. The phrase "at least one of" does not require selection of at least one item; rather, it allows for the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrase "at least one of A, B, or C" could refer to: only A, only B, or only C; or any combination of A, B, and C.

[0205] For example, phrases such as "aspect" do not imply that such aspect is essential to the present technology or that such aspect is applicable to all constructions of the present technology. Disclosure relating to an aspect may apply to all constructions, or one or more constructions. An aspect may provide one or more examples. For example, phrases such as "aspect" may refer to one or more aspects, and vice versa. For example, phrases such as "embodiment" do not imply that such embodiment is essential to the present technology or that such embodiment is applicable to all constructions of the present technology. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. For example, phrases such as "embodiment" may refer to one or more embodiments, and vice versa. For example, phrases such as "construction" do not imply that such construction is essential to the present technology or that such construction is applicable to all constructions of the present technology. Disclosure relating to a construction may apply to all constructions, or one or more constructions. A construction may provide one or more examples. For example, phrases such as "construction" may refer to one or more constructions, and vice versa.

[0206] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications given in this specification (including in the claims below) are approximate, not precise. In another aspect, they are intended to have a reasonable range consistent with the functions they relate to and with the custom in the field to which they belong.

[0207] 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. Depending on implementation preferences or scenarios, it should be understood that the specific order or hierarchy of steps, operations, or processes can be reconfigured. Some steps, operations, or processes may be performed concurrently. 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 methodological concepts present the elements of each step, operation, or process in a sample order and are not intended to limit one to the specific order or hierarchy presented.

[0208] All structural and functional equivalents of elements throughout the various aspects described herein that are well known to those skilled in the art or will be hereafter known are expressly incorporated herein by reference and are intended to be included in the concept. Furthermore, nothing disclosed herein is intended to be made public, whether or not such disclosure is expressly stated in the concept. Elements of the concept shall not be construed in accordance with 35 U.S.SC §112(f) unless the element is expressly stated using the phrase “device for XX”, or, in the case of a method claim concept, the element is stated using the phrase “step for XX.” Furthermore, with respect to the use of terms such as “comprising,” “having,” etc., such terms are intended to be inclusive, in a manner similar to the term “including,” as interpreted when “including” is used as a transitional term in the concept.

[0209] The title, background, summary, description of the drawings, and abstract of this disclosure are incorporated herein and are provided as illustrative examples rather than as limiting descriptions. It is understood that they are not intended to limit the scope or meaning of the concepts described. Furthermore, in the detailed description, it will be apparent that the description provides illustrative examples, and various features are combined in different embodiments to make the disclosure flow smoothly. This method of disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are explicitly listed in each concept. Rather, as reflected in the following concepts, the subject matter of the invention lies within fewer than all features of a single disclosed construction or operation. The following concepts are incorporated herein and each concept exists independently as a separately disclosed subject matter.

[0210] The concepts described herein are not intended to be limited to the aspects described herein, but should be given the full scope consistent with linguistic concepts and encompass all legally valid equivalents. Nevertheless, no concept is intended to include, nor should it be interpreted in this way, any subject matter that does not meet the requirements of 35 U.S.SC §101, 102, or 103.

Claims

1. A compounding system (10) for reconstituted, mixed, and delivered a drug from a vial to a receiving container, comprising: Tablet cartridge (16), which has: Multiple controllable fluid paths fluidly connected to at least one diluent port, waste port, and receiving container port (7302); and At least one ferromagnetic component; as well as Pump head assembly (28), which has: At least one mechanism operable to control the flow of fluid through the plurality of controllable fluid passages; and A passive magnet (15300) is configured to attach the cartridge (16) to the pump head assembly (28) using the at least one ferromagnetic component.

2. The compounding machine system (10) as described in claim 1, wherein, The magnet (15300) is mounted on the gripping arm (76) of the pump head assembly (28).

3. The compounding system (10) of claim 1 further includes a positive mechanical latching mechanism that provides an additional connection between the cartridge (16) and the pump head assembly (28), the positive mechanical latching mechanism being operated by the pump head assembly (28).

4. The compounding machine system (10) as described in claim 3, wherein, The positive mechanical latching mechanism includes a locking latch (128) disposed on the pump head assembly (28) and a keyhole (210) disposed in the cartridge (16).

5. The compounding machine system (10) as described in claim 1, wherein, The cartridge (16) includes a rotary piston pump / valve (13200) that can rotate to control the movement of fluid through at least one of the controllable fluid passages.

6. The compounding machine system (10) as described in claim 5, wherein, The rotary piston pump / valve (13200) includes a gear (13202) coupled to a rotary piston (13204) having a cavity (13206).

7. The compounding machine system (10) as described in claim 6, wherein, The rotary piston pump / valve (13200) includes a cam surface for linearly actuating the rotary piston (13204) during rotation of the rotary piston (13204) via the gear (13202).

8. The compounding machine system (10) as described in claim 7, wherein, The rotary piston pump / valve (13200) includes a housing (13201) in which the rotary piston (13204) is disposed, the housing (13201) having an input port (13208) and an output port (13210).

9. The compounding machine system (10) as described in claim 8, wherein, The rotary piston (13204) is configured to be linearly actuated in a first direction due to the action of a cam on the cam surface when the rotary piston (13204) rotates away from the first position, in which the cavity (13206) of the rotary piston (13204) is rotatably aligned with the input port (13208).

10. The compounding machine system (10) as described in claim 9, wherein, The rotary piston (13204) is configured to rotate from the first position to a second position, in which the cavity (13206) is rotatably aligned with the output port (13210).

11. The compounding machine system (10) as described in claim 10, wherein, The rotary piston (13204) is further configured to be linearly actuated in a second direction due to the action of an additional cam on the cam surface as the rotary piston (13204) rotates from the first position to the second position.

12. The compounding machine system (10) as described in claim 11, wherein, The rotary piston (13204) is further configured to stop rotating to prevent fluid flow between the input port (13208) and the output port (13210).

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