Semi-automated compounding platform

Abstract

The compounding platform includes a compounding station having a user interface and a rotating device. The compounding platform includes a chamber coupled to the compounding station. The rotating device is coupled to the chamber and is configured to rotate the chamber relative to the compounding station. The compounding platform further includes a consumable configured to be placed inside the chamber and having a plurality of ports and a bladder in fluid communication with the plurality of ports. The compounding platform has a first vial detachably coupled to the consumable via a first port of the plurality of ports and containing a diluent fluid, and a second vial detachably coupled to the consumable via a second port of the plurality of ports and containing a drug. The compounding platform includes a plurality of valves configured to control the flow of fluid in and out of the bladder and corresponding to the plurality of ports.

Description

Technical Field

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[0001] The present disclosure generally relates to a semi - automatic compounding platform, particularly a semi - automatic compounding platform for the preparation of parenteral medications.

Background Art

[0002] Medical treatment often involves the infusion of medical fluids (e.g., saline or liquid medications) to a patient using an intravenous (IV) catheter connected to a fluid source, such as an IV bag, via a combination of flexible tubes and fittings. A compounding platform can be used for the preparation of parenteral medications for infusion.

[0003] Conventional compounding platforms can be manual or semi - automatic. Conventional compounding platforms require many consumables used during the preparation of infusion medications. In addition, conventional compounding platforms require many steps and / or procedures, resulting in significant user interaction. Furthermore, conventional compounding platforms require high - cost components such as syringe pumps and complex consumables, increasing the overall cost of the compounding platform. <00​​​​​​​​​​​​The present invention relates to a compounding platform comprising: a first vial, which contains a diluent, and is removably coupled to a consumable via a first port of a plurality of ports; a second vial, which contains a drug, and is removably coupled to a consumable via a second port of a plurality of ports; and a plurality of valves configured to control the flow of fluid in and out of a bladder, the plurality of valves corresponding to a plurality of ports.

[0006] In some embodiments, the consumable includes a sealing element configured to communicate a bladder with multiple ports. The chamber includes a slot, and the consumable is positioned through the slot such that the sealing element engages with the slot to secure the bladder within the chamber. By inserting the consumable through the slot and positioning the sealing element within the slot, the chamber becomes airtight. The sealing element includes a first port and a second port.

[0007] In some embodiments, the bladder includes a first flow path in fluid communication with a first port and a second flow path in communication with a second port. The plurality of valves include a first valve and a second valve, the first valve configured to block the flow in the first flow path and the second valve configured to block the flow in the second flow path. When the first vial is coupled to the first port, the first flow path is in fluid communication with the first vial. When the second vial is coupled to the second port, the second flow path is in fluid communication with the second vial.

[0008] In some embodiments, the compounding platform further includes a delivery bag detachably coupled to a consumable via a third port of a plurality of ports. The third port is coupled to a delivery tube, which couples the delivery bag to the third port.

[0009] In some embodiments, the compounding platform further includes a pressure device coupled to a chamber, the pressure device configured to generate a vacuum within the chamber.

[0010] In some embodiments, the compounding platform further includes a pressing device coupled to a chamber, the pressing device including a pressing surface located within the chamber, the pressing device having a retracted position and an extended position, in which case the pressing device is closer to the bladder than when the pressing device is in the retracted position.

[0011] In some embodiments, the chamber is a vacuum chamber.

[0012] In some embodiments, the first and second ports enable bidirectional fluid communication.

[0013] In some embodiments, the bladder includes an internal space that is in fluid communication with the first vial and the second vial.

[0014] In some embodiments, the compounding platform further includes a control device located within the compounding station and communicatively coupled to a user interface, the control device being configured to cause the compounding station to perform a series of operations in response to inputs received via the user interface, the series of operations including one or more of rotating a chamber, opening one of a plurality of valves, and generating a vacuum within the chamber.

[0015] In some embodiments, the rotating device rotates the chamber from its base position to 360 degrees relative to the mixing station.

[0016] One or more embodiments of the present disclosure are a compounding platform comprising a compounding station including a user interface and a rotary device configured to receive input from a user, a chamber coupled to the compounding station and having a slot, the rotary device being coupled to the chamber and rotating the chamber by 0 to 360 degrees from a reference position relative to the compounding station, and a consumable configured to be disposed within the chamber, the consumable comprising a sealing element, a plurality of ports, and a bladder fluid-communicating with the plurality of ports, the chamber comprising a slot, the consumable being disposed through the slot such that the sealing element engages with the slot to secure the bladder within the chamber, a first vial detachably coupled to the consumable via a first port of the plurality of ports, the first vial containing a diluent, and a second vial detachably coupled to the consumable via a second port of the plurality of ports, the second vial containing a drug, and the bladder , a second vial including an internal space that fluidly communicates with the first and second vials, a plurality of valves configured to control the flow of fluid in and out of the bladder, the plurality of valves corresponding to a plurality of ports, a pressing device coupled to a chamber, the pressing device including a pressing surface located within the chamber, the pressing device having a retracted position and an extended position, in the extended position the pressing device is closer to the bladder than when the pressing device is in the retracted position, and a pressure device coupled to a chamber, pressure The compounding platform comprises a force device comprising a pressure device configured to generate a vacuum in a chamber and a delivery bag detachably coupled to a consumable via a third port of a plurality of ports, a bladder comprising a first flow path in fluid communication with a first port and a second flow path in communication with a second port, and a plurality of valves comprising a first valve and a second valve, the first valve configured to block the flow in the first flow path and the second valve configured to block the flow in the second flow path.

[0017] One or more embodiments of the present disclosure are methods for compounding a medical fluid, the methods comprising: inserting a consumable through a slot in a chamber to position the consumable in a chamber, the consumable comprising a bladder configured to inflate; creating a vacuum in the chamber to produce an inflow of air for entry into the consumable through a first port; removably coupling a first vial to the chamber, the first vial comprising a drug fluid and fluid-communicating with a first port of the consumable when coupled to the chamber to allow the drug fluid to flow from the first vial to the bladder; and rotating the chamber to allow air from the consumable to flow into the first vial through the first port, thereby allowing a predetermined amount of drug fluid to flow from the first vial into the consumable; and closing the first port and opening a second port coupled to a delivery bag so that a predetermined amount of drug fluid flows through the second port to a delivery bag.

[0018] One or more embodiments of the present disclosure are methods for reconstituting a medical fluid, the method comprising generating a vacuum in a chamber, the chamber comprising a consumable connected to a compounding station and having a first port and a second port, generating a vacuum by allowing an inflow of air into the consumable, the first port and the second port being in fluid communication with the consumable, and removing the vacuum from the chamber by opening a first valve of a plurality of valves to allow air to flow from the consumable into a first vial, as a result a dilution fluid flows from the first vial through the first port to the consumable, the first vial being connected to the first port such that the first vial is in fluid communication with the consumable when the first valve is open, and removing the vacuum by moving the chamber substantially inverted from a reference position. A method for reconstituting a medical fluid, comprising: rotating a chamber via a rotary device that connects the chamber to a compounding station; opening a second valve of a plurality of valves in response to the rotation of the chamber to allow a diluent fluid to flow from a consumable to a second vial, the second vial being coupled to a second port such that the second vial is in fluid communication with the consumable when the second valve is open, and the second vial contains a drug; vibrating the chamber via the rotary device so that the second vial is vibrated, causing the drug to at least partially dissolve in the diluent fluid in the second vial and produce a reconstituted fluid; and rotating the chamber via the rotary device relative to a reference position so that the reconstituted fluid flows from the second vial to the consumable via the second port.

[0019] Various configurations of the subject art will be readily apparent to those skilled in the art from this disclosure, but it will be understood that these various configurations of the subject art are shown and described as illustrative. As will be recognized, the subject art is capable of other different configurations, and some of its details can be modified in various other ways without all of them departing from the scope of the subject art. Accordingly, the summary, drawings and detailed description should be considered illustrative and not restrictive in nature.

[0020] The accompanying drawings are included to provide a further understanding and are incorporated in and constitute a part of this specification, illustrating the disclosed embodiments and, together with the description, serving to explain the principles of the disclosed embodiments.

Brief Description of the Drawings

[0021] [Figure 1A] A front perspective view of a dispensing platform according to various aspects of the present disclosure. [Figure 1B] An enlarged front perspective view of a consumable of the dispensing platform of FIG. 1A according to various aspects of the present disclosure. [Figure 1C] A side view of the dispensing platform of FIG. 1A according to various aspects of the present disclosure. [Figure 2A] A front view of a consumable of the dispensing platform of FIG. 1A according to various aspects of the present disclosure. [Figure 2B] A perspective side view of a consumable of FIG. 2A according to various aspects of the present disclosure. [Figure 3A] An enlarged side view of the dispensing platform of FIG. 1A with the pressing device in the initial position according to various aspects of the present disclosure. [Figure 3B] An enlarged side view of the dispensing platform of FIG. 1A with the pressing device in a partially extended position according to various aspects of the present disclosure. [Figure 3C] An enlarged side view of the dispensing platform of FIG. 1A with the pressing device in a fully extended position according to various aspects of the present disclosure. ​​​​​​​​​​Front view of the compounding platform of FIG. 1A during use of the compounding platform according to various aspects of the present disclosure. [Figure 5] Front perspective view of the compounding platform of FIG. 1A during use of the compounding platform according to various aspects of the present disclosure. **DETAILED DESCRIPTION**

[0022] The disclosed compounding platform enables the transfer of a measured amount of fluid from one or more vials to a final delivery container or bag. The term "fluid" as used herein may refer to any type of fluid such as a liquid or a gas. The compounding platform enables the mixing of diluents and drugs by selectively controlling the flow path of the fluid from the vial to the delivery bag. In some embodiments, the compounding platform controls the diluent-to-drug ratio such that a user can specify a particular diluent-to-drug ratio to be delivered to the delivery bag. The delivery bag may be used to store a medical fluid that is delivered to a patient, such as by an intravenous drip. The delivery bag may contain a medical fluid that has been titrated and / or compounded by the compounding platform for delivery to the patient.

[0023] The compounding platform includes a compounding station, consumables, and a delivery bag. The consumables are coupled to the compounding station such that the compounding station controls the flow of fluid into and out of the consumables. The compounding station can include a chamber configured to house the consumables. For example, the consumables may be disposed within the chamber of the compounding station, and various pumps or valves may be connected to the consumables to control the flow of fluid into and out of the consumables. The consumables are further coupled to the delivery bag. In some embodiments, the consumables are coupled to the delivery bag via a tube such as a delivery tube.

[0024] A consumable includes one or more ports, including inlets and outlets. The ports of the consumable are configured to connect to one or more vials so that fluid can flow from vials into the consumable. For example, the consumable may include a bladder filled with fluid from vials connected to the ports. The ports may allow bidirectional fluid flow. For example, the ports may allow fluid to flow into and out of the bladder of the consumable. The consumable may include ports that allow fluid to flow from the bladder through a delivery tube to a delivery bag.

[0025] In some embodiments, the consumables are located within a chamber of a compounding station. The compounding station may include a pressure device coupled to the chamber. The pressure device may be configured to generate a vacuum within the chamber. The chamber may be a vacuum chamber, and a vacuum can be applied to the bladder when the consumables are placed inside the chamber. In some embodiments, insertion of the consumables into the chamber seals the chamber, thereby allowing a vacuum to be applied inside the chamber. Furthermore, the application of a vacuum may be used to control the flow of fluid into the bladder. For example, to draw fluid into the bladder, a desired flow path is set to open through a valve coupled to one of the ports of the consumables. Other ports may remain closed. A vacuum is applied to the chamber, drawing the fluid into the bladder.

[0026] The compounding station includes one or more devices for interacting with the consumables and / or bladder. For example, the compounding station may include a pressing device and a rotating device. The pressing device may be a linear actuator having a pressing surface. The pressing surface is located within the chamber and is configured to press against the bladder of the consumables to prevent over-expansion of the bladder. For example, to control the volume of fluid drawn into the bladder, the pressing device positions the pressing surface close to the bladder to form an expansion boundary or limit. The position of the pressing surface can be adjusted based on the amount of volume expected to flow into the bladder. The compounding platform can apply a vacuum within the chamber and position the pressing surface so that a desired volume is drawn into the bladder.

[0027] A rotating device is coupled to the chamber and configured to rotate the chamber. For example, the rotating device can rotate the chamber to allow fluid to flow from one or more vials coupled to the consumables into the bladder with the help of gravity. The rotating device is configured to allow rotation of the chamber and consumables relative to the mixing station and delivery bag. In some embodiments, the rotating device allows for a rocking or vibrating motion of the chamber to allow for mixing of the fluids within the bladder.

[0028] A compounding station may include one or more valves or pumps coupled to each port. For example, each port of a consumable may have a corresponding valve coupled to the port to control the opening and closing of the port. The valves may control the flow of fluid from the vial coupled to the port into the bladder. A compounding station may also include a processor (e.g., a controller), such as a microcontroller, configured to control various aspects and devices of the compounding platform, such as rotating and pressing devices.

[0029] The detailed descriptions below are intended to describe various configurations of the Art and not to present a limited number of configurations in which the Art can be implemented. The detailed descriptions include specific details for the purpose of providing a complete understanding of the subject art. However, it will be apparent to those skilled in the art that the Art can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagrams to avoid ambiguity of the subject art concepts. Similar components are represented by the same element number for ease of understanding. Reference numbers are generally referred to by the same number without subscripts, although subscripts may be added to indicate distinct examples of common elements.

[0030] The following description pertains to the preparation of medical fluids by a compounding platform for delivery to a patient; however, it should be understood that this description is merely an example of use and does not limit the scope of the claims. Various embodiments of the disclosed compounding systems may be used in any application where it is desirable to provide medical fluids to a patient.

[0031] The disclosed formulation platform overcomes several challenges found with certain conventional formulation platforms. One challenge with certain conventional formulation platforms is that they may be difficult to use or require expensive components. For example, certain conventional formulation platforms require significant user interaction or require expensive components.

[0032] Therefore, according to this disclosure, it is advantageous to provide a formulation platform such as the one described herein that enables improved formulations of medical fluids.

[0033] Figure 1A is a front perspective view of a compounding platform according to various embodiments of this disclosure. Figure 1B is a close-up front perspective view of the consumables of the compounding platform of Figure 1A according to various embodiments of this disclosure. Figure 1C is a side view of the compounding platform of Figure 1A according to various embodiments of this disclosure.

[0034] Referring to Figures 1A to 1C, the compounding platform 100 enables the preparation of a fluid (e.g., a medical fluid) for delivery to a patient. For example, the compounding platform 100 may enable the preparation of a parenteral drug for delivery to a patient. The term fluid as used herein may refer to any type of fluid, such as a liquid or a gas. The compounding platform 100 prepares the fluid (e.g., a medical fluid) and may store the prepared fluid in a container such as a delivery bag 180. The container may be infused into or attached to the patient via one or more catheters or needles.

[0035] The compounding platform 100 may include a compounding station 102, a chamber 110, a storage area 185, and a user interface 190. The user interface 190 may be used to control the compounding station 102. For example, a user may interact with the user interface 190 to specify parameters for the preparation of a medical fluid. The medical fluid may be prepared by the compounding platform 100 and stored in a delivery bag 180 so that the medical fluid can be delivered to a patient. The user interface 190 may receive input from the user and may include a touchscreen, keyboard, buttons, switches, or other input mechanisms.

[0036] In some embodiments, the compounding station 102 includes a controller, such as a microcontroller, configured to control one or more processes of the compounding station 102. For example, the controller may be coupled to a user interface 190 and configured to receive input from the user interface 190 and to control one or more other devices or components of the compounding station 102 to prepare the medical fluid.

[0037] In some embodiments, the compounding platform 100 includes a chamber 110. The chamber 110 may be coupled to a compounding station 102. The chamber 110 may be configured to house consumables (e.g., consumables 120). The chamber 110 may be a vacuum chamber configured to contain a vacuum when the consumables 120 are placed inside. The chamber 110 may be coupled to the compounding station 102 such that the chamber 110 is rotatable relative to the compounding station 102.

[0038] In some embodiments, the storage area 185 is configured to store a delivery bag 180. The delivery bag 180 may be a container for storing medical fluids. The delivery bag 180 may be coupled to a consumable 120 located within the chamber 110. The delivery bag 180 may be coupled to the consumable 120, for example, via a delivery tube 170. In some embodiments, the delivery tube 170 is detachably coupled to the delivery bag 180 and / or the consumable 120.

[0039] In some embodiments, the delivery tube 170 can connect the delivery bag 180 to the consumables 120 in fluid communication. When in use, the delivery bag 180 may contain a medical fluid to be delivered to the patient. For example, the delivery bag 180 may contain a medical fluid to be infused to the patient via a delivery line. The delivery tube 170 may be configured to be detached from the delivery bag 180. For example, when the storage of the desired fluid in the delivery bag 180 via the compounding station 102 is complete, the delivery tube 170 may be detached from the delivery bag 180 to allow the delivery bag 180 to be transported to another location for use.

[0040] The medical fluid may be a combination of a diluent and a drug. In some embodiments, the compounding platform 100 is configured to prepare the medical fluid by selectively controlling the flow of the diluent and drug into the consumables 120, which may then flow into the delivery bag 180. For example, the compounding station 102 may be configured to selectively control one or more valves or pumps to control the flow of fluid to a fluid source (e.g., diluent vials and / or drug vials) and from the fluid source to the consumables 120 stored in the chamber 110.

[0041] In some embodiments, the consumable 120 is located within the chamber 110 and coupled to one or more vials. For example, the consumable 120 may be coupled to a first vial 140 and a second vial 160. In some embodiments, the first vial 140 is a vial containing a diluent fluid, and the second vial 160 is a vial containing a drug, such as a lyophilized drug. The consumable 120 may be in fluid communication with the first vial 140 and the second vial 160. The consumable 120 may be substantially airtight.

[0042] The chamber 110 may include a proximal wall 113, a distal wall 115, a side wall 117, and an upper wall 119. The side wall 117 may be positioned between the proximal wall 113 and the distal wall 115, thereby connecting the proximal wall 113 to the distal wall 115. The side wall 117 may extend over most of the perimeter of the chamber 110. In some embodiments, the upper wall 119 extends between the proximal wall 113 and the distal wall 115. The upper wall 119 may extend from one end of the side wall 117 to the other end of the side wall 117. For example, the side wall 117 may be substantially semicircular, and the upper wall 119 may be connected to the end of the side wall 117. In some embodiments, the upper wall 119 includes a slot 121. The slot 121 is configured to accommodate a consumable 120. For example, a consumable 120 may be inserted through a slot 121 to position the consumable 120 within the chamber 110. In some embodiments, the slot 121 secures the consumable 120 in a predetermined position within the chamber 110. The slot 121 may be configured to bond to a sealing element 128 of the consumable 120 to secure the consumable within the slot 121. The slot 121 may secure the consumable 120 within the chamber 110 and may provide an airtight seal between the consumable 120 and the chamber 110. In other words, the slot 121 may form an airtight seal with the sealing element 128 when the consumable 120 is positioned within the chamber 110 through the slot 121.

[0043] In some embodiments, slot 121 is located near the distal wall 115. As a result of slot 121 being located near the distal wall 115, the consumable 120 is located near the distal wall 115 when it is placed inside the chamber 110. In some embodiments, when the consumable 120 is placed inside the chamber 110, it may be located near the side wall 117 and the distal wall 115. For example, the periphery of the consumable 120 may be substantially parallel to the side wall 117 and may be located near the side wall 117. In some embodiments, the contour around the consumable 120 corresponds to the contour of the side wall 117.

[0044] In some embodiments, the chamber 110 includes one or more valves or pumps (e.g., valves 109a, 109b, 109c) configured to control the flow of fluid to and from the consumable 120. For example, valve 109a may be controlled by motor 108a and may be configured to control the flow of fluid from the first vial 140 into and from the consumable 120. Valve 109b may be controlled by motor 108b and may be configured to control the flow of fluid from the consumable 120 (e.g., through port 126) to the delivery bag 180 via the delivery line 170. Valve 109a may be controlled by motor 108c and may be configured to control the flow of fluid from the second vial 160 into and from the consumable 120. Each valve 109a, 109b, and 109c has a corresponding motor 108a, 108b, and 108c that controls the valve, as will be described in detail below.

[0045] In some embodiments, the compounding station 102 includes a rotating device 107 and a pressurizing device 106. The rotating device 107 may include a motor and may be configured to rotate the chamber 110 relative to the compounding station 102. For example, the rotating device 107 may be coupled to the chamber 110 and may be configured to rotate 360 ​​degrees relative to the compounding station 102 so that the chamber 110 rotates relative to the compounding station 102. In some embodiments, the rotating device 107 can rotate the chamber 110 360 degrees relative to the compounding station 102. For example, the chamber 110 may have a reference position (e.g., 0 degrees) and may be rotated by the rotating device 107 from the reference position. In some embodiments, the reference position of the chamber 110 is such that the fluid in the bladder 130 of the consumable 120 is on the opposite side from the sealing element 128 and / or the vial coupled to the consumable 120 due to gravity. For example, when the chamber 110 is in the reference position, any fluid placed within the consumable 120 is furthest from the sealing element 128, any ports, or any vials coupled to the consumable 120.

[0046] The rotating device 107 may be located near the pressure device 106. In some embodiments, the pressure device 106 is located within or through the rotating device 107. For example, the rotating device 107 may be coupled to the chamber 110, and the pressure device 106 may be located within and along the rotating device 107.

[0047] In some embodiments, the pressure device 106 controls the pressure in the chamber 110. The pressure device 106 may include an air tube or channel coupled to the chamber 110, configured to add air to or remove air from the chamber 110 to increase or decrease the pressure in the chamber 110. In some embodiments, the pressure device 106 is configured to remove all air from the chamber 110 to create a vacuum in the chamber 110. The pressure device 106 may be coupled to the chamber 110 such that the pressure device 106 forms an airtight seal with the chamber 110 to enable the creation of a vacuum in the chamber 110. The creation of a vacuum in the chamber 110 may drive a fluid, such as air or liquid, into a bladder (e.g., bladder 130) located inside the chamber 110. For example, the creation of a vacuum in the chamber 110 may cause an inflow of air into the consumable 120. The vacuum may be removed from the chamber 110, resulting in the bladder remaining filled with fluid. In other words, a vacuum may be used to drive a fluid into a bladder located within the chamber 110.

[0048] In some embodiments, the compounding station 102 includes a pressing device 105. The pressing device 105 may be a linear actuator and may include a pressing surface 112. The pressing device 105 may be located near the rotating device 107 and / or the pressure device 106. In some embodiments, the pressing surface 112 is located within the chamber 110. The pressing device 105 is configured to extend and retract the pressing surface 112. For example, the pressing device 105 and the pressing surface 112 may have an initial position (Figure 3A), a partially extended position (Figure 3B), and a fully extended position (Figure 3C). In some embodiments, the partially extended position is where the pressing surface 112 is between the initial position and the fully extended position. In the initial position, the pressing surface 112 is fully retracted to form the inner surface of the chamber 110.

[0049] The pressing surface 112 may extend into the chamber 110 from its initial position. For example, the pressing surface 112 may be substantially coplanar with the proximal wall 113 when the pressing surface 112 is in its initial position. In some embodiments, the pressing surface 112 is in contact with or near the proximal wall 113 when the pressing surface 112 is in its initial position. In some embodiments, the pressing device 105 includes a rod 104. The rod 104 may be configured to connect the pressing surface 112 to a motor of the pressing device 105. For example, by extending the rod 104, the pressing surface 112 may extend from its initial position to a fully extended position.

[0050] The pressing device 105 may be configured to extend the pressing surface 112 toward the distal wall 115. For example, in the initial position, the pressing surface 112 may be in contact with the proximal wall 113 or located closer to the proximal wall 113 compared to the distal wall 115, and in the partially extended position, the pressing surface 112 may be extended away from the proximal wall 115 so that the pressing surface is positioned between the proximal wall 113 and the distal wall 115. In some embodiments, when the pressing surface 112 is in the partially extended position, the pressing surface 112 is closer to the distal wall 115 compared to when the pressing surface 112 is in the initial position. When the pressing surface 112 is in the fully extended position, the pressing surface 112 may be in contact with the consumable 120 so that the consumable 120 does not contain fluid. When the pressing surface 112 is fully extended, it presses the consumable 120 against the distal wall 115. As will be explained below, when the pressing surface 112 is fully extended, the consumable 120 is pressed against the pressing surface 112 and the distal wall 115, causing the fluid to flow out of the consumable 120.

[0051] The chamber 110 may include an opening 103 that fluidly communicates the chamber 110 with the pressing device 107. The opening 103 may be located in the proximal wall 113. The pressing surface 112 may substantially seal the opening 103 when the pressing device 112 is in its initial position. As the pressing surface 112 extends toward the distal wall 115, the pressing surface 112 may move away from the opening 103, and the opening 103 is no longer sealed by the pressing surface 112. In some embodiments, since the pressing device 107 is fluidly communicating with the chamber 110 through the opening 103, the vacuum applied to the chamber 110 causes the vacuum to be applied to the pressing device 107.

[0052] Figure 2A is a front view of the consumables of the compounding platform shown in Figure 1A, according to various embodiments of this disclosure. Figure 2B is a perspective side view of the consumables of Figure 2A, according to various embodiments of this disclosure.

[0053] Referring to Figures 2A and 2B, the consumable 120 may include a sealing element 128 and a bladder 130. The bladder 130 may be coupled to the sealing element 128. In some embodiments, the bladder 130 is heat-sealed to the sealing element 128 so that the consumable 120 remains substantially airtight. The consumable 120 may include ports 122, 124, and 126. In some embodiments, the ports 122, 124, and 126 are configured to allow fluid to flow into and out of the bladder 130. Each of the ports 122, 124, and 126 may be located on the sealing element 128. The consumable 120 may consist of plastic or polymer. In some embodiments, the sealing element 128 consists of rigid plastic and the bladder 130 consists of a plastic film. The sealing element 128 may be coupled to the bladder 130 such that the consumable 120 is airtight.

[0054] Ports 122 and 124 may be connected to a fluid source. For example, port 122 may be connected to a first vial 140, and port 124 may be connected to a second vial 160. Ports 122 and 124 may include needles 122a and 124a, respectively. Needle 122a may extend from port 122, and needle 124a may extend from port 124. Needles 122a and 124a may be configured to extend into the fluid vial when the fluid vial is connected to port 122 and port 124, respectively. Needles 122a and 124a may extend from a sealing element 128. During use, the fluid source is connected to port 122 and / or port 124, and needles 122a and / or 124a extend from port 122 and / or 124 into the fluid source. In some embodiments, ports 122, 124, and 126 include any type of coupling mechanism for connecting a fluid source to ports 122, 124, and 126. For example, ports 122, 124, and 126 may each include a connection interface to enable optimized and easy connection between ports 122, 124, and 126 and a fluid source.

[0055] Port 126 may be configured to be coupled to the delivery tube 170 to allow fluid to flow from the bladder 130 to the delivery bag 180. In some embodiments, port 126 is a one-way outlet configured to allow fluid to flow from the bladder 130 to the delivery bag 180 without allowing fluid to flow from the delivery bag 180 to the bladder 130. Alternatively, port 126 is a two-way valve that allows flow from the delivery bag 180 to the bladder 130 and from the bladder 130 to the delivery bag 180. In some embodiments, the axis of port 126 is positioned perpendicular to the axes of port 122 and / or port 124. For example, the axis extending through port 122 and / or 124 may extend into the bladder 130 and may be parallel to the bladder 130. The axis extending through port 126 may be perpendicular to bladder 130 and parallel to the plane of sealing element 128. In some embodiments, the plane extending through at least a large portion of bladder 130 is substantially perpendicular to the plane extending through at least a large portion of sealing element 128.

[0056] In some embodiments, the consumable 120 includes channels 123, 127, and 125 extending into the bladder 130 from ports 122, 126, and 124, respectively. Each channel 123, 127, and 125 may be formed via a heat-sealed portion of the bladder 130. For example, portions of the bladder 130 near ports 122, 124, and 126 near a sealing element 128 may be heat-sealed to form channels 123, 127, and 125. Channel 123 may extend from port 122, channel 127 may extend from port 126, and channel 125 may extend from port 124. Channels 123, 127, and 125 may direct the fluid flow in and out of the bladder 130 from ports 122, 126, and 124, respectively. In some embodiments, channels 123 and 125 are inlet channels that direct the flow from the fluid source into the bladder 130, and channel 127 is an outlet channel that directs the flow from the bladder 130 to a fluid container (e.g., a delivery bag 180).

[0057] In some embodiments, valves 109a, 109b, and 109c are configured to control the flow of fluid (e.g., gas or liquid) through passages 123, 127, and 125, respectively. Valve 109a may be in an open position, allowing fluid to flow through passage 123. When valve 109a is in a closed position, it may seal passage 123, preventing fluid from flowing through passage 123 to the inside and outside of bladder 130. Valve 109b may be in an open position, allowing fluid to flow through passage 127. When valve 109b is in a closed position, it may seal passage 127, preventing fluid from flowing through passage 127 to the inside and outside of bladder 130. Valve 109c may be in an open position, allowing fluid to flow through passage 125. When valve 109c is in a closed position, it may seal passage 125, preventing fluid from flowing through passage 125 to the inside and outside of bladder 130.

[0058] In some embodiments, one or more of the valves 109a, 109b, and 109c are configured to control the flow of air into the bladder 130. For example, valve 109a and / or valve 109c may draw air into the bladder 130 before the installation of vials 140 and / or vials 160. In some embodiments, air is drawn into the bladder 130 by a press device 107 creating a vacuum in the chamber 110. For example, the press device 107 may create a vacuum in the chamber 110, causing air to flow into the bladder 130 through one or more of the valves 109a, 109b, and 109c, thereby inflating the bladder 130.

[0059] Valves 109a, 109b, and 109c may be solenoid valves or plungers configured to extend and retract to control the flow through passages 123, 127, and 125. For example, valves 109a, 109b, and 109c may extend outward to seal passages 123, 127, and 125, and may retract inward to open passages 123, 127, and 125 and allow fluid to flow through them. In some embodiments, motors 108a, 108b, and 108c and / or valves 109a, 109b, and 109c extend into the chamber 110. For example, motors 108a, 108b, 108c and / or valves 109a, 109b, 109c may extend into the chamber 110 such that the motors 108a, 108b, 108c and / or valves 109a, 109b, 109c are located near the consumable 120 when the consumable 120 is placed inside the chamber 110.

[0060] Valves 109a, 109b, and 109c may be coupled to a microcontroller located within the compounding station 102. The microcontroller may be configured to control the extension and retraction of valves 109a, 109b, and 109c. In some embodiments, the compounding station 102 is configured to perform or advance predetermined steps (e.g., rotation of chamber 110, operation of pressure device 105 and / or pressing device 107) based on a program executed by the microcontroller.

[0061] In some embodiments, the bladder 130 includes an internal space 132. The internal space 132 may be configured to be filled with fluid when fluid enters the bladder 130 through ports 122, 124, and / or 126. In some embodiments, the internal space 132 is formed by heat-sealing a portion of the bladder 130. The internal space 132 may be a defined portion of the bladder 130 configured to expand and contract. For example, the internal space 132 may expand when the bladder 130 accepts fluid and contract when the fluid flows out of the bladder 130. The internal space 132 and the bladder 130 may be substantially airtight. In some embodiments, the bladder 130 consists of two plastic films sealed around the periphery to form an airtight bladder. The two plastic films containing the bladder 130 may be in contact when the bladder 130 is substantially deflated so that it no longer contains any fluid. Once the bladder 130 accepts the fluid and is filled with it, the two plastic films may be separated. The amount of fluid that the bladder 130 can hold is determined based on the size of the internal space 132. For example, the larger the volume of the internal space 132, the larger the volume of fluid that the bladder 130 can hold.

[0062] Figure 3A is an enlarged side view of the compounding platform of Figure 1A with the pressing device in its initial position, according to various embodiments of this disclosure. Figure 3B is an enlarged side view of the compounding platform of Figure 1A with the pressing device in a partially extended position, according to various embodiments of this disclosure. Figure 3C is an enlarged side view of the compounding platform of Figure 1A with the pressing device in a fully extended position, according to various embodiments of this disclosure.

[0063] Referring to Figures 3A to 3C, the pressing surface 112 may have an initial position (Figure 3A), a partially retracted position (Figure 3B), and a fully extended position (Figure 3C). In the initial position, the pressing device 105 retracts the pressing surface 112 so that it is positioned close to the proximal wall 113. In the initial position, the pressing surface 112 may be positioned within the wall 113 or may be in contact with the wall 113. When the pressing surface 112 moves from the initial position to the partially extended position, the pressing device 105 may extend the pressing surface 112 toward the distal wall 115.

[0064] When the pressing surface 112 is between its initial position and its fully extended position, the pressing surface 112 may be in a partially extended position. In some embodiments, as shown in Figure 3B, when the pressing surface 112 is in a partially extended position and the internal space 132 of the bladder 130 is at least partially filled with fluid, the pressing surface 112 abuts against or contacts the bladder 130. For example, the bladder 130 may receive fluid from a fluid source (e.g., a first vial 140 and / or a second vial 160) so that the volume of the internal space 132 expands. The pressing surface 112 may be in a partially extended position and may be positioned close to the bladder 130 so that the internal space 132 expands and contacts the pressing surface 112.

[0065] The pressing surface 112 may be configured to prevent excessive expansion of the internal space 132 of the bladder 130. For example, the pressing surface 112 may be configured to provide an expansion limit for the bladder 130 (e.g., the internal space 132). The pressing surface 112 may be positioned close to the bladder 130 so that when the internal space 132 expands, the internal space 132 comes into contact with the pressing surface 112, thereby preventing it from expanding further and thereby limiting the further flow of fluid into the internal space 132. In some embodiments, the user may set a specific position of the pressing surface 112 relative to the bladder 130 to control the expansion limit of the internal space 132, thereby controlling the volume of fluid that the bladder 130 accepts and holds.

[0066] In some embodiments, as shown in Figure 3C, the pressing surface 112 may be in a fully extended position, so that the pressing surface 112 contacts the bladder 130 when the internal space 132 is substantially fluid-free. The pressing device 105 may move the pressing surface 112 from a partially extended position (Figure 3B) to a fully extended position (Figure 3C). In some embodiments, the pressing surface 112 extended to the fully extended position presses the pressing surface 112 against the bladder 130, thereby contracting the internal space 132 and pushing the fluid out of the bladder 130. For example, the pressing surface 112 may be moved to a fully extended position, so that the pressing surface 112 presses against the bladder 130, causing the fluid in the internal space 132 to flow out of the bladder 130 and substantially emptying or eliminating the fluid from the internal space 132.

[0067] In some embodiments, the compounding station 102 is configured to draw fluid into the bladder 130 of the consumable 120 so that the internal space 132 is filled with fluid. For example, when the consumable 120 is placed in the chamber 110, the consumable may substantially seal the chamber 110. Valves 109a, 109b, and 109c may be moved to an extended position so as to seal the passages 123, 127, and 125, respectively. When valves 109a, 109b, and 109c are extended, the valves are pressed against the passages 123, 127, and 125, respectively, and seal them. As described above, when valves 109a, 109b, and 109c are retracted, the passages 123, 127, and 125 are opened, respectively, and become free to allow the flow of fluid or gas in and out of the bladder 130.

[0068] To draw fluid into the internal space 132 of the bladder 130, desired passages from passages 123, 127, and 125 are opened via corresponding valves (e.g., valves 109a, 109b, and 109c). The remaining passages may be closed. For example, valve 109a may be retracted, and valves 109b and 109c may be extended, resulting in the opening of passage 123 and the closing of passages 127 and 125. By opening passage 123, fluid may flow into the internal space 132 only through passage 123 and port 122.

[0069] In some embodiments, a vacuum is applied to the chamber 110, resulting in fluid being drawn into the bladder 130 via the port 122 and the flow path 123. For example, a pressure device 106 may create a vacuum in the chamber 110 by removing all the air in the chamber 110. The creation of a vacuum in the chamber 110 causes the bladder 130 of the chamber 110 and consumable 120 to be at a lower pressure than the fluid source (e.g., the first vial 140 and / or the second vial 160), causing the fluid to flow from the fluid source into the internal space 132 of the bladder 130.

[0070] In some embodiments, to control the volume of fluid drawn into the internal space 132 of the bladder 130, the pressing device 105 extends the pressing surface 112 so that the pressing surface 112 is positioned closer to the bladder 130, thereby forming an expansion limit (e.g., Figure 3B). The position of the pressing surface 112 and certain parameters of the vacuum formed by the chamber 110 may be correlated with the magnitude of the volume expected to flow into and fill the internal space 132. In some embodiments, the compounding platform 100 utilizes the correlation to adjust the position of the pressing surface 112 and the generation of vacuum in the chamber 110 until a desired volume is drawn into the internal space 132 of the bladder 130.

[0071] In some embodiments, desired passages from passages 123, 127, and 125 are opened via corresponding valves (e.g., valves 109a, 109b, and 109c) to push or expel fluid from the internal space 132 of the bladder 130. The remaining passages may be closed. For example, valve 109b may be retracted and valves 109a and 109c may be extended, resulting in the opening of passage 127 and the closing of passages 123 and 125. With passage 127 open, fluid may flow out of the internal space 132 only through passage 127 and port 126. In some embodiments, to push or expel fluid from the internal space 132, the pressing device 105 extends the pressing surface 112 relative to the bladder 130 (for example, to a fully extended position), applies force to the internal space 132, and contracts the internal space 132, thereby expelling fluid from the open passage (e.g., passage 127) and the port (e.g., port 126) that is in fluid communication with the passage. In some embodiments, the volume of fluid pushed out or removed from the internal space 132 of the bladder 130 is correlated with the change in the position of the pressing surface 112.

[0072] Figure 4A is a front view of the compounding platform in Figure 1A in use, according to various embodiments of this disclosure. Figure 4B is a front view of the compounding platform in Figure 1A in use, according to various embodiments of this disclosure. Figure 4C is a front view of the compounding platform in Figure 1A in use, according to various embodiments of this disclosure. Figure 4D is a front view of the compounding platform in Figure 1A in use, according to various embodiments of this disclosure.

[0073] Referring to Figures 4A to 4D, the compounding platform 100 may be configured to reconstitute a drug vial, such as a second vial 160. For example, the compounding platform 100 may allow adjustment of the ratio of diluent to drug (e.g., pharmaceutical) within the vial or fluid container.

[0074] In some embodiments, the consumable 120 is inserted through a slot 121 in the chamber 110, securing the consumable 120 within the chamber 110. The user may interact with the user interface 190 to select a desired routine or program for the compounding platform 100 and have it executed to achieve a desired result. For example, the user may interact with the user interface 190 to select a routing directed to reconfigure the vial. The compounding platform 100 may then proceed with an automated or semi-automated process to reconfigure the vial.

[0075] Reconstituting the vials (e.g., the second vial 160) requires the fluid to flow from one or more vials into the bladder 130 and from the bladder 130 into one or more vials. The reconstituted fluid may then be transferred from the bladder 130 to one or more vials and / or storage containers (e.g., delivery bag 180).

[0076] In some embodiments, one or more of the valves 109a, 109b, and 109c are closed to block one or more of the passages 123, 127, and 125. For example, valves 109b and 109c may be closed, and valve 109a may be left open. As a result, fluid can flow into port 122 through passage 123, while fluid is prevented from flowing into ports 126 and 124 through passages 127 and 125, respectively. Vacuum may be applied into the chamber 110 by a pressure device 106, thereby drawing a predetermined volume of air into the internal space 132 of the bladder 130. The vacuum is then removed from the chamber 110.

[0077] In some embodiments, the first vial 140 is connected to port 122, and the second vial 160 is connected to port 124. The first vial 140 may be a fluid source for a diluent, and the second vial 160 may be a fluid source for a drug, such as a lyophilized drug source. The delivery bag 180 may be located in the storage area 185 of the compounding station 102 and may be connected to port 126 via the delivery tube 170.

[0078] The compounding station 102 may be configured to perform a series of pressing and pulling routines or operations for transferring fluid between the first vial 140 and / or the second vial 160 and the bladder 130. For example, the compounding station 102 may open one or more valves (e.g., valves 109a, 109b, 109c) and the rotating chamber 110 to allow fluid to flow between the first vial 140 and / or the second vial 160 and the bladder 130.

[0079] In some embodiments, the internal space 132 contains a predetermined volume of air due to the vacuum formed in the chamber 110, resulting in air flowing into the bladder 130. The pressing surface 112 may be extended by a pressing device 105, thereby applying pressure to the internal space 132, which is partially expanded with air. By opening the valve 109a, the air from the internal space 132 may be pushed out of the bladder 130, through the flow path 123, and through the port 122 into the first vial 140. A fluid, such as a diluent from the first vial 140, may be pushed out of the first vial 140 into the internal space 132 through the port 122 and the flow path 123 as air is pushed out of the bladder 130 into the first vial 140 and the fluid is pushed out of the first vial 140 into the bladder 130. In other words, as shown in Figure 4A, air may be pushed from the internal space 132 into the first vial 140, and fluid may be pushed from the first vial 140 into the internal space 132.

[0080] Referring to Figure 4B, the diluting fluid from the first vial 140 may be transferred from the first vial 140, placed in the internal space 132, and then transferred from the internal space 132 to the second vial 160. For example, the chamber 110 may be rotated or inverted by a rotating device 107 so that the chamber 110 is inverted from its reference position (for example, rotated 180 degrees). Before the rotation or inversion of the chamber 110, valve 109c may be opened and valves 109a and 109c may be closed so that the second vial 160 is in fluid communication with the bladder 130 through port 124 and flow path 125, while the first vial 140 is no longer in fluid communication with the bladder 130.

[0081] When the chamber 110 is substantially inverted or rotated by 180 degrees, the diluent fluid may flow from the internal space 132 through the channel 125 and port 124 into the second vial 160. The second vial 160 may contain a drug or pharmaceutical agent. The drug or pharmaceutical agent placed in the second vial 160 may be configured to dissolve in a diluent fluid, such as the diluent fluid placed in the first vial 140. In some embodiments, a vacuum is formed in the chamber 110 and / or the pressing device 105 presses the pressing surface 112 against and retracts from the bladder 130, causing the diluent fluid in the bladder 130 to flow into the second vial 160.

[0082] In some embodiments, the phase of the diluent fluid from the internal space 132 to the second vial 160 causes the air transferred to the first vial 140 to be transferred back to the internal space 132, resulting in the second vial 160 containing at least partially the diluent fluid and the internal space 132 containing at least partially air (e.g., from the first vial 140). The transfer of the diluent fluid from the internal space 132 to the second vial 160 causes the air pushed out of the second vial 160 by the diluent fluid to be transferred into the internal space 132, resulting in the second vial 160 containing at least partially the diluent fluid and the internal space 132 containing at least partially air (e.g., from the second vial 160).

[0083] In some embodiments, numerous inversions and / or rotations are required to completely transfer the dilution fluid from the internal space 132 to the second vial 160. The delivery tube 170 may be coupled to the consumable 120 and may be configured to allow numerous rotations of the chamber 110 and consumable 120 without damage. For example, the delivery tube 170 may have a predetermined length that allows numerous rotations of the chamber 110 and consumable 120 without the delivery tube 170 being twisted and damaged. In some embodiments, the delivery tube 170 includes a pre-twisted section to help minimize undesirable twisting and damage to the delivery tube 170.

[0084] Referring to Figure 4C, when the chamber 110 is inverted and the diluent fluid flows into the second vial 160, the rotating device 107 may be configured to rotate or vibrate the chamber 110. For example, the rotating device 107 may rotate the chamber 110 clockwise by a predetermined amount, and then rotate the chamber 110 counterclockwise by a predetermined amount. The rotation or vibration of the chamber 110 may cause vibration or mixing of the substances within the second vial 160, as the second vial 160 is coupled to the consumable 120 located inside the chamber 110. For example, the vibration of the chamber 110 may cause mixing of the diluent fluid and the drug in the second vial 160, completely dissolving the drug in the diluent and forming a reconstituted fluid. In some embodiments, during vibration of the chamber 110, valves 109a, 109b, and 109c are closed to prevent the reconstituted fluid from flowing from the second vial 160 into the bladder 130.

[0085] After the chamber 110 is at 180 degrees from the reference position and the dilution fluid has flowed into the second vial 160, the rotating device 107 may vibrate or oscillate the chamber 110 between 180 and 270 degrees and between 180 and 90 degrees. In some embodiments, rotating the device 107 vibrates the chamber 110 from any position between 0 and 360 degrees from the reference position of the chamber 110, completely dissolving the drug in the dilution fluid in the second vial 160 and forming a reconstituted fluid.

[0086] Referring to Figure 4D, during the vibration of chamber 110 and the dissolution of the drug in the dilution fluid in the second vial 160, chamber 110 may return to its reference position. When chamber 110 returns to its reference position, valve 109c may be opened, allowing the reconstituted fluid to flow from the second vial 160 into the bladder 130 via port 124 and flow path 125. Air from the internal space 132 may be pushed out by the reconstituted fluid and flow into the second vial 160. In some embodiments, a vacuum is formed in chamber 110 and / or the pressing device 105 presses the pressing surface 112 against and retracts from the pressing against the bladder 130, allowing the reconstituted fluid in the second vial 160 to flow into the bladder 130.

[0087] Figure 5 is a front perspective view of the compounding platform shown in Figure 1A in use, according to various aspects of this disclosure.

[0088] Referring to Figure 5, the reconfigured fluid placed in the bladder 130 may be transferred to the delivery bag 180 via the delivery tube 170. For example, when the reconfigured fluid is transferred to the internal space 132, the valve 109 may extend to close the passage 125, obstructing the flow of fluid through port 124 and passage 125. The valve 109b may retract to open passage 127, thereby allowing the fluid to flow from the internal space 132 through passage 127 and port 126 to the delivery bag 180 coupled to port 126 via the delivery tube. In some embodiments, a vacuum is formed in the chamber 110 and / or the pressing surface 112 is pressed against and retracted from the bladder 130 by a pressing device 105, causing the reconfigured fluid in the internal space 132 to flow into the delivery bag 180 via the delivery tube 170.

[0089] In some embodiments, the chamber 110 is rotated before the reconstituted fluid is transferred to the delivery bag 180. For example, the chamber 110 may be rotated substantially 180 degrees from its reference position, and the reconstituted fluid may be transferred from the internal space 132 to the delivery bag 180. Inversion of the chamber 110 before the transfer of the reconstituted fluid to the delivery bag 180 can prevent or minimize the entry of air into the delivery bag 108.

[0090] In some embodiments, the delivery tube 170 includes a first end 171 coupled to a consumable 120 and a second end 173 coupled to a delivery bag 180. The second end 173 may include a male Luer coupling for delivering the tube 170 to the delivery bag 180. In some embodiments, to facilitate the handling of hazardous substances, the second end 173 is provided with or an interface to a leak-proof or leak-free drug transfer device, such as a closed system drug transfer device (CSTD). For example, if one or more of the first vials 140 and / or the second vials 160 contain hazardous material, the second end 173 may include a leak-proof or leak-free drug transfer device to prevent leakage of hazardous material when the delivery tube 170 is removed from the delivery bag 180, in order to prevent injury to individuals around the compounding platform 100.

[0091] In some embodiments, the second end 173 includes a hazardous drug safety needle. For example, the second end 173 may include a ballpoint safety needle intended to protect healthcare during removal of the second end 173 from the delivery bag 180. In some embodiments, the ballpoint safety needle includes a spring and a protective ballpoint positioned above the needle. The spring may be extended so that the protective ballpoint covers the tip of the needle. The protective ballpoint may be retracted by applying force to expose the needle. When the force is removed, the protective ballpoint may extend to cover the tip of the needle due to the spring being biased to extend.

[0092] In some embodiments, the consumable 120 is disposable. For example, the consumable 120 may be disposable, allowing the user to dispose of it upon completion of a desired task (e.g., generating the reconstituted fluid and transferring the reconstituted fluid to the delivery bag 180). In some embodiments, once the second end 173 is removed from the delivery bag 180, the consumable 120 is discarded along with the first vial 140, the second vial 160 and / or the delivery tube 170. The consumable 120 may be discarded along with the first vial 140, the second vial 160 and / or the delivery tube 170 if the drug or medication originally stored in the second vial 160 is hazardous. In some embodiments, once the reconstituted fluid is transferred from the second vial 160 to the bladder 130, the consumable 120 may be removed from the chamber 110 and stored in a safe place for later use.

[0093] In some embodiments, the compounding platform 100 is configured to generate a reconstituted fluid for transfer to a delivery bag 180. For example, with the chamber 110 in a reference position, the diluent fluid may be transferred from the first vial 140 to the internal space 132 using a series of extensions and contractions of valves 109a, 109b, and 109c, and the drug from the second vial 160 may be transferred from the second vial 160 to the internal space 132. In some embodiments, the diluent fluid and the drug are transferred to the internal space 132 simultaneously. Once the diluent fluid and the drug are transferred to the internal space 132, the chamber 110 may be rotated and / or vibrated by a rotating device 107, thereby dissolving the drug in the diluent fluid and generating a reconstituted fluid in the internal space 132.

[0094] In some embodiments, once the reconstituted fluid is generated, the reconstituted fluid may be transferred to the delivery bag 180 via the delivery tube 170. Before transferring the reconstituted fluid to the delivery bag 180, the chamber 110 may be inverted to prevent air from being transferred to the delivery bag 180.

[0095] In some embodiments, the delivery bag 180 is empty before the fluid is transferred from the bladder 130 to the delivery bag 180. Alternatively, the delivery bag 180 may contain a fluid, such as saline solution, which is configured to mix with the reconstituted fluid when the reconstituted fluid is transferred from the bladder 130 to the delivery bag 180.

[0096] The disclosures described herein include at least the following provisions:

[0097] Clause 1: A compounding platform comprising: a compounding station including a user interface and a rotating device configured to receive input from a user; a chamber coupled to the compounding station, the rotating device being coupled to the chamber and configured to rotate the chamber relative to the compounding station; a consumable configured to be placed inside the chamber, the consumable including a plurality of ports and a bladder fluidly communicating with the plurality of ports; a first vial detachably coupled to the consumable via a first port of the plurality of ports, the first vial containing a diluent; a second vial detachably coupled to the consumable via a second port of the plurality of ports, the second vial containing a drug; and a plurality of valves configured to control the flow of fluid in and out of the bladder, the plurality of valves corresponding to the plurality of ports.

[0098] Clause 2: The formulation platform according to claim 1, wherein the consumables include a sealing element configured to communicate a bladder with multiple ports.

[0099] Clause 3: The compound platform according to claim 2, wherein the chamber includes a slot, and consumables are arranged through the slot so that a sealing element engages with the slot to secure a bladder within the chamber.

[0100] Clause 4: The compounding platform according to claim 3, wherein the chamber becomes airtight by inserting consumables through slots and arranging sealing elements within the slots.

[0101] Clause 5: The formulation platform according to claim 2, wherein the sealing element includes a first port and a second port.

[0102] Clause 6: The formulation platform according to claim 1, wherein the bladder includes a first flow path in fluid communication with a first port and a second flow path in communication with a second port.

[0103] Clause 7: The compounding platform according to claim 6, wherein the plurality of valves include a first valve and a second valve, the first valve being configured to block the flow in a first flow path, and the second valve being configured to block the flow in a second flow path.

[0104] Clause 8: The compounding platform according to claim 6, wherein the first flow path is in fluid communication with the first vial when the first vial is coupled to the first port.

[0105] Clause 9: The compounding platform according to claim 6, wherein the second flow path is in fluid communication with the second vial when the second vial is coupled to the second port.

[0106] Clause 10: The formulation platform according to claim 1, further comprising a delivery bag detachably coupled to a consumable via a third port of a plurality of ports.

[0107] Clause 11: The formulation platform according to claim 10, wherein a third port is connected to a delivery tube, and the delivery tube connects a delivery bag to the third port.

[0108] Clause 12: The compounding platform according to claim 1, further comprising a pressure device coupled to a chamber, the pressure device configured to generate a vacuum within the chamber.

[0109] Clause 13: The compounding platform according to claim 1, further comprising a pressing device coupled to a chamber, the pressing device comprising a pressing surface located within the chamber, the pressing device having a retracted position and an extended position, in the extended position the pressing device is closer to the bladder than when the pressing device is in the retracted position.

[0110] Clause 14: The formulation platform according to claim 1, wherein the chamber is a vacuum chamber.

[0111] Clause 15: The compounding platform according to claim 1, wherein the first port and the second port enable bidirectional fluid communication.

[0112] Clause 16: The formulation platform according to claim 1, wherein the bladder includes an internal space in fluid communication with a first vial and a second vial.

[0113] Clause 17: The compounding platform according to claim 1, further comprising a control device located within the compounding station and communicatively coupled to a user interface, the control device being configured to cause the compounding station to perform a series of operations in response to inputs received via the user interface, the series of operations including one or more of rotating a chamber, opening one of a plurality of valves, and generating a vacuum within the chamber.

[0114] Clause 18: The compounding platform according to claim 1, wherein the rotating device rotates the chamber from a base position to 360 degrees relative to the compounding station.

[0115] Clause 19: A compounding platform comprising a compounding station including a user interface and a rotary device configured to receive input from a user; a chamber coupled to the compounding station and having a slot, the rotary device being coupled to the chamber and rotating the chamber by 0 to 360 degrees from a reference position relative to the compounding station; a consumable configured to be disposed within the chamber, the consumable comprising a sealing element, a plurality of ports, and a bladder fluid-communicated with the plurality of ports, the chamber including a slot, the consumable being disposed through the slot such that the sealing element engages with the slot to secure the bladder within the chamber; a first vial detachably coupled to the consumable via a first port of the plurality of ports, the first vial containing a diluent; a second vial detachably coupled to the consumable via a second port of the plurality of ports, the second vial containing a drug, and the bladder being the first A compounding platform comprising: a second vial including an internal space that fluidly communicates with a first vial and a second vial; a plurality of valves configured to control the flow of fluid in and out of the bladder, the plurality of valves corresponding to a plurality of ports; a pressing device coupled to a chamber, the pressing device including a pressing surface located within the chamber, the pressing device having a retracted position and an extended position, in the extended position being closer to the bladder than when the pressing device is in the retracted position; a pressure device coupled to a chamber, the pressure device configured to generate a vacuum within the chamber; and a delivery bag detachably coupled to a consumable via a third port of a plurality of ports, wherein the bladder includes a first flow path fluidly communicating with a first port and a second flow path communicating with a second port, the plurality of valves including a first valve and a second valve, the first valve configured to block the flow in the first flow path and the second valve configured to block the flow in the second flow path.

[0116] Clause 20: A method for compounding a medical fluid, the method comprising: inserting a consumable through a slot in a chamber to place the consumable in a chamber, the consumable comprising a bladder configured to inflate; creating a vacuum in the chamber to produce an inflow of air for entry into the consumable through a first port; removably coupling a first vial to the chamber, the first vial comprising a drug fluid and fluid-communicating with a first port of the consumable when coupled to the chamber to allow the drug fluid to flow from the first vial to the bladder; rotating the chamber to allow air from the consumable to flow into the first vial through the first port, thereby allowing a predetermined amount of drug fluid to flow from the first vial into the consumable; and closing the first port and opening a second port coupled to a delivery bag so that a predetermined amount of drug fluid flows through the second port to a delivery bag.

[0117] Clause 21: A method for reconstituting a medical fluid, the method comprising generating a vacuum in a chamber, the chamber comprising a consumable connected to a compounding station and having a first port and a second port, the generation of the vacuum involves allowing an inflow of air into the consumable, the first port and the second port being in fluid communication with the consumable, generating a vacuum, and removing the vacuum from the chamber, the method comprising opening a first valve of a plurality of valves to allow air to flow from the consumable into a first vial, as a result a dilution fluid flows from the first vial through the first port to the consumable, the first vial being connected to the first port such that the first vial is in fluid communication with the consumable when the first valve is open, and removing the vacuum, the chamber being substantially inverted from a reference position, the chamber A method for reconstituting a medical fluid, comprising: rotating a chamber via a rotating device connected to a compounding station; opening a second valve of a plurality of valves in response to the rotation of the chamber to allow a dilution fluid to flow from a consumable to a second vial, the second vial being coupled to a second port such that the second vial is in fluid communication with the consumable when the second valve is open, and the second vial contains a drug; vibrating the chamber via the rotating device so that the second vial is vibrated and the drug is at least partially dissolved in the dilution fluid in the second vial to produce a reconstituted fluid; and rotating the chamber via the rotating device relative to a reference position so that the reconstituted fluid flows from the second vial to the consumable via the second port.

[0118] This disclosure is provided to enable any person skilled in the art to practice the various embodiments described herein. While this disclosure provides various examples of the subject art, the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and the comprehensive principles defined herein may be applicable to other embodiments.

[0119] References to singular elements are not intended to mean "one and only one" unless explicitly stated so, but rather "one or more." Unless explicitly stated otherwise, the term "several" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, where present, are for convenience only and do not limit the invention.

[0120] The term “exemplary” is used herein to mean “serving as an example or illustration.” No embodiment or design described herein as “exemplary” is necessarily considered preferable or advantageous to any other embodiment or design. In one embodiment, various alternative configurations and operations described herein may be considered at least equivalent.

[0121] The terms "aspects" and similar phrases do not imply that such aspects are essential to the subject art, nor that such aspects are compatible with all configurations of the subject art. Disclosure relating to a particular aspect may be compatible with all configurations or one or more configurations. An aspect may provide one or more examples. Terms such as "aspects" may refer to one or more aspects, and vice versa. The terms such as "examples" and similar phrases do not imply that such examples are essential to the subject art, nor that such examples are compatible with all configurations of the subject art. Disclosure relating to a particular example may be compatible with all examples, or one or more examples. An example may provide one or more examples. Terms such as "examples" may refer to one or more examples, and vice versa. The terms such as "configuration" and similar phrases do not imply that such configurations are essential to the subject art, nor that such configurations are compatible with all configurations of the subject art. Disclosure relating to a particular configuration may be compatible with all configurations, or one or more configurations. A particular configuration may provide one or more examples. Terms such as "composition" may refer to one or more compositions, and vice versa.

[0122] In one embodiment, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications specified herein, including those in the subsequent claims, are approximate and not exact. In one embodiment, they are intended to have a reasonable range that is consistent with the function to which they relate and with what is customary in the art to which they relate.

[0123] In one embodiment, the term "connected" may refer to being directly connected. In another embodiment, the term "connected" may refer to being indirectly connected.

[0124] When used in this disclosure, terms such as “up,” “down,” “front,” and “rear” should be understood to refer to an arbitrary reference frame, rather than a normal gravity-based reference frame. Therefore, the top, bottom, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in a gravity-based reference frame.

[0125] Various matters may be arranged in different ways (for example, in different orders or divided in different ways) without departing from the scope of the subject art. All structural and functional equivalents of elements in various forms described throughout this disclosure, which are known to or will be known to those skilled in the art, are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be made available to the general public, whether such disclosure is expressly stated in the claims or not. No element of any claim should be construed under 112, Section 6 of the U.S. Patent Act unless it is expressly described using the phrase “means for” or, in the case of a method claim, the phrase “steps for.” Furthermore, with respect to the use of terms such as “includes,” “have,” etc., such terms are intended to be as comprehensive as “comprise,” as the term “comprise” is interpreted when used as a transitional term in a claim.

[0126] The title, background art, summary of the invention, brief description of the drawings, and abstract of this disclosure are incorporated herein by reference and are provided as exemplary examples of the disclosure, not as restrictive descriptions. This disclosure is filed with the understanding that they are not used to limit the scope or meaning of the claims. In addition, it can be seen that in the modes for carrying out the invention, the descriptions provide exemplary examples and various features are grouped together in various embodiments for the purpose of simplifying the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are explicitly described in each claim. Rather, as reflected in the following claims, the subject matter of the invention consists of fewer features than all features of a single disclosed configuration or operation. The following claims stand alone as claimed subject matter and are incorporated herein by reference.

[0127] The claims are not intended to be limited to the embodiments described herein, but rather to be given the full scope consistent with the verbatimized claims and to encompass all legal equivalents. Nevertheless, no claim is intended to encompass, nor should they be construed as, subject matter that does not meet the requirements of Sections 101, 102, or 103 of the U.S. Patent Act.

Claims

1. It is a compounding platform, A mixing station including a user interface and a rotating device configured to receive input from a user, A chamber coupled to the mixing station, wherein the rotating device is coupled to the chamber and configured to rotate the chamber relative to the mixing station, A consumable configured to be placed within the chamber, the consumable includes a plurality of ports and a bladder that is in fluid communication with the plurality of ports, A first vial is removably coupled to the consumable via a first port of the plurality of ports, the first vial contains a diluent, and the first vial and A second vial is removably coupled to the consumable via a second port of the plurality of ports, the second vial contains a drug, and the second vial and A compounding platform comprising a plurality of valves configured to control the flow of fluid in and out of the bladder, wherein the plurality of valves include a plurality of valves corresponding to the plurality of ports.

2. The compounding platform according to claim 1, wherein the consumable includes a sealing element configured to connect the bladder to the plurality of ports.

3. The compounding platform according to claim 2, wherein the chamber includes a slot, and the consumables are arranged through the slot such that the sealing element engages with the slot to secure the bladder within the chamber.

4. The compounding platform according to claim 3, wherein the chamber becomes airtight by inserting the consumables through the slot and arranging the sealing element within the slot.

5. The formulation platform according to claim 2, wherein the sealing element includes the first port and the second port.

6. The compounding platform according to claim 1, wherein the bladder includes a first flow path in fluid communication with the first port and a second flow path in communication with the second port.

7. The compounding platform according to claim 6, wherein the plurality of valves include a first valve and a second valve, the first valve being configured to block the flow in the first flow path, and the second valve being configured to block the flow in the second flow path.

8. The compounding platform according to claim 6, wherein the first flow path is in fluid communication with the first vial when the first vial is coupled to the first port.

9. The compounding platform according to claim 6, wherein the second flow path is in fluid communication with the second vial when the second vial is coupled to the second port.

10. The compounding platform according to claim 1, further comprising a delivery bag detachably coupled to the consumables via a third port among the plurality of ports.

11. The compounding platform according to claim 10, wherein the third port is connected to a delivery tube, and the delivery tube connects the delivery bag to the third port.

12. The compounding platform according to claim 1, further comprising a pressure device coupled to the chamber, wherein the pressure device is configured to generate a vacuum within the chamber.

13. The compounding platform according to claim 1, further comprising a pressing device coupled to the chamber, the pressing device comprising a pressing surface disposed within the chamber, the pressing device having a retracted position and an extended position, wherein in the extended position the pressing device is closer to the bladder than when the pressing device is in the retracted position.

14. The compounding platform according to claim 1, wherein the chamber is a vacuum chamber.

15. The compounding platform according to claim 1, wherein the first port and the second port enable bidirectional fluid communication.

16. The compounding platform according to claim 1, wherein the bladder includes an internal space that is in fluid communication with the first vial and the second vial.

17. The compounding platform according to claim 1, further comprising a control device disposed within the compounding station and communicably coupled to the user interface, the control device being configured to cause the compounding station to perform a series of operations in response to the input received via the user interface, the series of operations including one or more of rotating the chamber, opening one of the plurality of valves, and generating a vacuum within the chamber.

18. The mixing platform according to claim 1, wherein the rotating device rotates the chamber from a basic position to 360 degrees relative to the mixing station.

19. It is a compounding platform, A mixing station including a user interface and a rotating device configured to receive input from a user, A chamber coupled to the mixing station and having slots, wherein the rotating device is coupled to the chamber and rotates the chamber from a reference position by 0 to 360 degrees relative to the mixing station, A consumable configured to be placed within the chamber, the consumable comprising a sealing element, a plurality of ports, and a bladder in fluid communication with the plurality of ports, wherein the chamber includes a slot, and the consumable is positioned through the slot such that the sealing element engages with the slot to secure the bladder within the chamber. A first vial is removably coupled to the consumable via a first port of the plurality of ports, the first vial contains a diluent, and the first vial and A second vial is removably coupled to the consumable via a second port of the plurality of ports, the second vial contains a drug, and the bladder includes an internal space that is in fluid communication with the first vial and the second vial, A plurality of valves configured to control the flow of fluid to and from the bladder, wherein the plurality of valves include a plurality of valves corresponding to the plurality of ports, A pressing device coupled to the chamber, wherein the pressing device includes a pressing surface disposed within the chamber, the pressing device has a retracted position and an extended position, and in the extended position, the pressing device is closer to the bladder than when the pressing device is in the retracted position, A pressure device coupled to the chamber, the pressure device being configured to generate a vacuum within the chamber, Includes a delivery bag detachably coupled to the consumable via a third port among the plurality of ports, A compounding platform wherein the bladder includes a first flow path in fluid communication with the first port and a second flow path in communication with the second port, and the plurality of valves include a first valve and a second valve, the first valve configured to block the flow in the first flow path and the second valve configured to block the flow in the second flow path.

20. A method for compounding medical fluids, wherein the method is Inserting a consumable into a chamber by inserting the consumable through a slot in the chamber, wherein the consumable includes a bladder configured to expand. To generate a vacuum in the chamber in order to create an inflow of air for the consumables to enter through the first port, The first vial is removably coupled to the chamber, wherein the first vial contains a drug fluid and, when coupled to the chamber, is in fluid communication with the first port of the consumable, allowing the drug fluid to flow from the first vial to the bladder. Rotating the chamber to allow the air from the consumable to flow into the first vial via the first port, which involves rotating to allow a predetermined amount of the drug fluid to flow from the first vial into the consumable, A method for formulating a medical fluid, comprising closing the first port and opening the second port, which is connected to the delivery bag, so that a predetermined amount of the drug fluid flows through the second port to the delivery bag.

21. A method for reconstituting a medical fluid, wherein the method is The method involves generating a vacuum in a chamber, the chamber being connected to a mixing station and including a consumable having a first port and a second port, the generation of the vacuum causing an inflow of air into the consumable, and the first port and the second port being in fluid communication with the consumable. The vacuum is removed from the chamber by opening the first valve of a plurality of valves to allow the air to flow from the consumable into the first vial, so that the diluting fluid flows from the first vial through the first port to the consumable, and the first vial is coupled to the first port so that the first vial is in fluid communication with the consumable when the first valve is open. Rotating the chamber via a rotating device connected to the mixing station so that the chamber is substantially inverted from a reference position, In response to rotating the chamber, the second valve of the plurality of valves is opened to allow the diluting fluid to flow from the consumable to the second vial, wherein the second vial is coupled to the second port such that the second vial is in fluid communication with the consumable when the second valve is open, and the second vial contains a drug, The second vial is vibrated, and the chamber is vibrated via the rotating device to at least partially dissolve the drug in the dilution fluid in the second vial and generate a reconstituted fluid, A method for reconstituting a medical fluid, comprising rotating the chamber relative to the reference position via the rotating device, and flowing the reconstituted fluid from the second vial through the second port to the consumable.

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