Preparation platform

Abstract

A dispensing platform includes a dispensing station having a user interface and a rotating device. The dispensing platform includes a chamber coupled to a dispensing station. A rotation device is coupled to the chamber and configured to rotate the chamber relative to the dispensing station. The formulation platform also includes a consumable configured to be disposed within the chamber and including a plurality of ports and a bladder in fluid communication with the plurality of ports. The formulation platform has a first vial that is removably coupled to the consumable via a first port of the plurality of ports and includes a diluent fluid, and a second vial that is removably coupled to the consumable via a second port of the plurality of ports and includes a medicament. The dispensing platform includes a plurality of valves configured to control fluid flow into and out of the bladder and corresponding to the plurality of ports.

Description

Technical Field

[0001] The present disclosure generally relates to a semi - automatic compounding platform, and more particularly to a semi - automatic compounding platform for preparing parenteral drugs. Background Art

[0002] Medical treatment typically involves infusing a medical fluid (e.g., a saline solution or a liquid drug) into a patient using an intravenous (IV) catheter, which is connected to a fluid source, such as an IV bag, through an arrangement of flexible tubing and fittings. A compounding platform can be used to prepare parenteral drugs for infusion.

[0003] Traditional compounding platforms can be manual or semi - automatic. Traditional compounding platforms require the use of many consumables during the preparation of the infused drug. In addition, traditional compounding platforms require many steps and / or procedures, which result in a large amount of user interaction. Moreover, traditional compounding platforms require expensive components, such as syringe pumps and complex consumables, increasing the total cost of the compounding platform. Summary of the Utility Model

[0004] One or more embodiments of the present disclosure relate to a compounding platform that includes: a compounding station that includes a user interface configured to receive input from a user and a rotating device; a chamber coupled to the compounding station, wherein the rotating device is coupled to the chamber and is configured to rotate the chamber relative to the compounding station; a consumable configured to be disposed within the chamber, the consumable including a plurality of ports and a bladder in fluid communication with the plurality of ports;

[0005] a first vial removably coupled to the consumable via a first port of the plurality of ports, the first vial including a diluent fluid, a second vial removably coupled to the consumable via a second port of the plurality of ports, the second vial including a drug, and a plurality of valves configured to control the flow of fluid into and out of the bladder, wherein the plurality of valves correspond to the plurality of ports.

[0006] In some embodiments, the consumable includes a sealing element configured to allow the bladder to communicate with the plurality of ports. The chamber includes a slot through which the consumable is disposed such that the sealing element engages the slot to secure the bladder within the chamber. The chamber is airtight when the consumable is inserted through the slot and the sealing element is disposed within the slot. 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 includes a first valve and a second valve, the first valve being configured to block flow within the first flow path and the second valve being configured to block flow within the second flow path. When a first vial is coupled to the first port, the first flow path is in fluid communication with the first vial. When a 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 formulation platform further includes a delivery bag removably coupled to the consumable via a third port of the plurality of ports. The third port is coupled to a delivery tube that couples the delivery bag to the third port.

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

[0010] In some embodiments, the formulation platform further includes a squeezing device coupled to the chamber, the squeezing device including a squeezing surface disposed within the chamber, the squeezing device having a retracted position and an extended position, wherein the squeezing device is closer to the bladder when in the extended position than when in the retracted position.

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

[0012] In some embodiments, the first port and the second port allow bidirectional fluid communication.

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

[0014] In some embodiments, the formulation platform further includes a controller disposed within the formulation station and communicatively coupled to a user interface, the controller being configured to cause the formulation station to perform a set of operations in response to an input received via the user interface, wherein the set of operations includes one or more of a rotation of the chamber, an opening of one of the plurality of valves, and a creation of a vacuum within the chamber.

[0015] In some embodiments, the rotating device rotates the chamber from a baseline position 0 degrees to 360 degrees relative to the formulation station.

[0016] One or more embodiments of the present disclosure relate to a formulation platform, comprising: a formulation station including a user interface configured to receive input from a user and a rotating device; a chamber coupled to the formulation station and having a slot, wherein the rotating device is coupled to the chamber and rotates the chamber from a baseline position 0 degrees to 360 degrees relative to the formulation station; a consumable configured to be disposed within the chamber, the consumable including a sealing element, a plurality of ports, and a bladder fluidly communicating with the plurality of ports, wherein the chamber includes a slot and the consumable is disposed through the slot such that the sealing element engages the slot to secure the bladder within the chamber; a first vial removably coupled to the consumable via a first port of the plurality of ports, the first vial including a diluent fluid; a second vial removably coupled to the consumable via a second port of the plurality of ports, the second vial including a drug, wherein the bladder includes an internal space fluidly communicating with the first vial and the second vial; a plurality of valves configured to control fluid flow into and out of the bladder, wherein the plurality of valves correspond to the plurality of ports; a squeezing device coupled to the chamber, the squeezing device including a squeezing surface disposed within the chamber, the squeezing device having a retracted position and an extended position, wherein the squeezing device is closer to the bladder when in the extended position than when in the retracted position; a pressure device coupled to the chamber, the pressure device configured to create a vacuum within the chamber; and a delivery bag removably coupled to the consumable via a third port of the plurality of ports, wherein the bladder includes a first flow path fluidly communicating with the first port and a second flow path communicating with the second port, and the plurality of valves includes a first valve and a second valve, the first valve configured to block flow within the first flow path and the second valve configured to block flow within the second flow path.

[0017] One or more embodiments of the present disclosure relate to a method of formulating a medical fluid, the method comprising: inserting a consumable through a slot of a chamber to dispose the consumable within the chamber, the consumable including a bladder configured to expand; creating a vacuum within the chamber to cause air to flow into the consumable through a first port; removably coupling a first vial containing a pharmaceutical fluid to the chamber, the first vial being in fluid communication with the first port of the consumable when coupled to the chamber to allow the pharmaceutical fluid to flow from the first vial to the bladder; rotating the chamber to cause air to flow from the consumable through the first port into the first vial, which causes a predetermined amount of the pharmaceutical 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 such that the predetermined amount of the pharmaceutical fluid flows through the second port to the delivery bag.

[0018] One or more embodiments of the present disclosure relate to a method of reconstituting a medical fluid, the method comprising: creating a vacuum within a chamber coupled to a formulation station and including a consumable having a first port and a second port, wherein creation of the vacuum causes air to flow into the consumable and the first port and the second port are in fluid communication with the consumable; removing the vacuum from the chamber and opening a first valve among a plurality of valves to cause air to flow from the consumable into a first vial such that a diluent fluid flows from the first vial through the first port to the consumable, the first vial being coupled to the first port such that when the first valve is opened, the first vial is in fluid communication with the consumable; rotating the chamber via a rotation device coupling the chamber to the formulation station such that the chamber is substantially inverted from a baseline position; in response to rotating the chamber, opening a second valve among the plurality of valves to cause the diluent fluid to flow from the consumable to a second vial, the second vial being coupled to the second port such that when the second valve is opened, the second vial is in fluid communication with the consumable, the second vial including a drug; oscillating the chamber via the rotation device such that the second vial is oscillated, thereby causing the drug to at least partially dissolve in the diluent fluid within the second vial to produce a reconstituted fluid; and rotating the chamber via the rotation device to the baseline position such that the reconstituted fluid flows from the second vial to the consumable via the second port.

[0019] It should be understood that, in accordance with the present disclosure, various structures of the subject technology will become apparent to those skilled in the art, where the various structures of the subject technology are shown and described by way of illustration. As will be recognized, the subject technology is capable of having other and different configurations and its several details are capable of being modified in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, the drawings, and the detailed description are to be regarded in an illustrative rather than a restrictive sense. Brief Description of the Drawings

[0020] The drawings are included to provide a further understanding, and are incorporated into and constitute a part of this specification. The drawings illustrate embodiments of the present disclosure and, together with the description, are used to explain the principles of the embodiments of the present disclosure.

[0021] In the drawings:

[0022] Figure 1A is a front perspective view of a formulation platform according to various aspects of the present disclosure.

[0023] Figure 1B is according to various aspects of the present disclosure Figure 1A is an enlarged front perspective view of a consumable of the formulation platform.

[0024] Figure 1C is according to various aspects of the present disclosure Figure 1A is a side view of the formulation platform.

[0025] Figure 2A is according to various aspects of the present disclosure Figure 1A is a front view of a consumable of the formulation platform.

[0026] Figure 2B is according to various aspects of the present disclosure Figure 2A is a perspective side view of the consumable.

[0027] Figure 3A is according to various aspects of the present disclosure Figure 1A is an enlarged side view of the formulation platform, where the extrusion device is in the initial position.

[0028] Figure 3B is according to various aspects of the present disclosure Figure 1A is an enlarged side view of the formulation platform, where the extrusion device is in a partially extended position.

[0029] Figure 3C is according to various aspects of the present disclosure Figure 1A is an enlarged side view of the formulation platform, where the extrusion device is in a fully extended position.

[0030] Figure 4A is according to various aspects of the present disclosure Figure 1A is a front view of the formulation platform in use.

[0031] Figure 4B is according to various aspects of the present disclosure Figure 1A is a front view of the formulation platform in use.

[0032] Figure 4C is according to various aspects of the present disclosureFigure 1A Front view of a compounding platform, where the compounding platform is in use.

[0033] Figure 4D is in accordance with various aspects of the present disclosure Figure 1A Front view of a compounding platform, where the compounding platform is in use.

[0034] Figure 5 is in accordance with various aspects of the present disclosure Figure 1A Front perspective view of a compounding platform, where the compounding platform is in use. Detailed Description

[0035] The disclosed compounding platform allows a quantified amount of fluid to move from one or more vials to a final delivery container or bag. The term fluid herein can refer to any type of fluid, such as a liquid or a gas. The compounding platform allows for the mixing of diluent and drug by selectively controlling the flow path of the fluid from the vial to the delivery bag. In some embodiments, the compounding platform controls the ratio of diluent to drug such that a user can specify a particular ratio of diluent to drug to be delivered to the delivery bag. The delivery bag can be used to store medical fluid, such as for delivery to a patient via infusion. The delivery bag can include medical fluid titrated and / or compounded by the compounding platform for delivery to a patient.

[0036] 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 receive the consumables. For example, the consumables can be placed within the chamber of the compounding station, and various pumps or valves can 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 fitting, such as a delivery tube.

[0037] The consumables include one or more ports, including an inlet and an outlet. The ports of the consumables are configured to be coupled to one or more vials to allow fluid to flow from the vials into the consumables. For example, the consumables can include a bladder filled with fluid from a vial coupled to the port. The port can allow bidirectional fluid flow. For example, the port can allow fluid to flow into the bladder of the consumables and out of the bladder. The consumables can include a port that allows fluid to flow from the bladder to the delivery bag via a delivery tube.

[0038] In some embodiments, the consumable is disposed within a chamber of a formulation station. The formulation station can include a pressure device coupled to the chamber. The pressure device can be configured to create a vacuum within the chamber. The chamber can be a vacuum chamber, and when the consumable is disposed within the chamber, a vacuum can be applied to the bladder. In some embodiments, inserting the consumable into the chamber seals the chamber to allow a vacuum to be applied within the chamber. Additionally, the application of the vacuum can 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 be opened via a valve coupled to one of the ports of the consumable. The other ports can remain closed. A vacuum is applied to the chamber to draw the fluid into the bladder.

[0039] The formulation station includes one or more devices that interact with the consumable and / or the bladder. For example, the formulation station can include an extrusion device and a rotation device. The extrusion device can be a linear actuator having an extrusion surface. The extrusion surface is disposed within the chamber and is configured to push against the bladder of the consumable to prevent the bladder from overexpanding. For example, to control the volume of fluid inhaled into the bladder, the extrusion device positions the extrusion surface close to the bladder to create an expansion boundary or limit. The position of the extrusion surface can be adjusted according to the expected volume of fluid flowing into the bladder. The formulation platform can apply a vacuum within the chamber and position the extrusion surface such that the desired volume is inhaled into the bladder.

[0040] The rotation device is coupled to the chamber and is configured to rotate the chamber. For example, the rotation device can rotate the chamber to allow fluid to flow from one or more vials coupled to the consumable into the bladder with the assistance of gravity. The rotation device is configured to allow the chamber and the consumable to rotate relative to the formulation station and the delivery bag. In some embodiments, the rotation device allows a rocking or shaking motion of the chamber to allow the fluid within the bladder to mix.

[0041] The formulation station can include one or more valves or pumps coupled to each port. For example, each port of the consumable can have a corresponding valve coupled thereto to control the opening and closing of the port. The valve can control the flow of fluid from the vial coupled to the port into the bladder. The formulation station can include a processor (e.g., a controller), such as a microcontroller, that is configured to control various aspects and devices of the formulation platform, such as the rotation device and the extrusion device.

[0042] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. It will be apparent, however, to one of ordinary skill in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. For ease of understanding, like components are labeled with like reference numerals. Reference numerals may be appended with a letter suffix to indicate separate instances of common elements, while common elements are generally referred to by the same numeral without a suffix letter.

[0043] Although the following description relates to preparing a medical fluid to be delivered to a patient via a compounding platform, it should be understood that this description is merely an example of use and does not limit the scope of the claims. Aspects of the disclosed compounding system can be used in any application that requires providing a medical fluid to a patient.

[0044] The disclosed compounding platform overcomes a number of challenges found with certain traditional compounding platforms. One challenge with certain traditional compounding platforms is that they can be very cumbersome to use or may require expensive components. For example, some traditional compounding platforms require a great deal of user interaction or expensive components.

[0045] Accordingly, it is advantageous, in accordance with the present disclosure, to provide a compounding platform as described herein that allows for improved compounding of medical fluids.

[0046] Figure 1A is a front perspective view of a compounding platform in accordance with various aspects of the present disclosure. Figure 1B is in accordance with various aspects of the present disclosure Figure 1A is an enlarged front perspective view of a consumable of the compounding platform. Figure 1C is in accordance with various aspects of the present disclosure Figure 1A is a side view of the compounding platform.

[0047] Referring Figures 1A - 1C , the compounding platform 100 allows for the preparation of a fluid (e.g., a medical fluid) for delivery to a patient. For example, the compounding platform 100 can allow for the preparation of a parenteral drug for delivery to a patient. The term fluid herein can refer to any type of fluid, such as a liquid or a gas. The compounding platform 100 can prepare a fluid (e.g., a medical fluid) and store the prepared fluid within a container (such as a delivery bag 180). The container can be injected into a patient or coupled to a patient via one or more catheters or needles.

[0048] The formulation platform 100 may include a formulation station 102, a chamber 110, a storage area 185, and a user interface 190. The user interface 190 may be used to control the formulation station 102. For example, a user may interact with the user interface 190 to specify parameters for preparing a medical fluid. The medical fluid may be prepared by the formulation platform 100 and stored within a delivery bag 180 such that the medical fluid may be delivered to a patient. The user interface 190 may receive input from the user and may include a touch screen, a keyboard, buttons, switches, or other input mechanisms.

[0049] In some embodiments, the formulation station 102 includes a controller, such as a microcontroller, that is configured to control one or more processes of the formulation station 102. For example, the controller may be coupled to the user interface 190 and may be configured to receive input from the user interface 190 and control one or more other devices or components of the formulation station 102 to prepare the medical fluid.

[0050] In some embodiments, the formulation platform 100 includes a chamber 110. The chamber 110 may be coupled to the formulation station 102. The chamber 110 may be configured to receive consumables (e.g., consumable 120). The chamber 110 may be a vacuum chamber that is configured to contain a vacuum when the consumable 120 is placed therein. The chamber 110 may be coupled to the formulation station 102 such that the chamber 110 is rotatable relative to the formulation station 102.

[0051] In some embodiments, the storage area 185 is configured to store the delivery bag 180. The delivery bag 180 may be a container for storing the medical fluid. The delivery bag 180 may be coupled to the consumable 120 disposed within the chamber 110. For example, the delivery bag 180 may be coupled to the consumable 120 via a delivery tube 170. In some embodiments, the delivery tube member 170 may be removably coupled to the delivery bag 180 and / or the consumable 120.

[0052] In some embodiments, the delivery tube 170 permits fluid communication between the delivery bag 180 and the consumable 120. In use, the delivery bag 180 may contain the medical fluid to be delivered to the patient. For example, the delivery bag 180 may include the medical fluid to be infused to the patient via a delivery line. The delivery tube 170 may be configured to be separated from the delivery bag 180. For example, after the required fluid is stored within the delivery bag 180 via the formulation station 102, the delivery tube member 170 may be separated from the delivery bag 180 to permit the delivery bag 180 to be transported to another location for use.

[0053] The medical fluid can be a combination of a diluent and a drug. In some embodiments, the formulation platform 100 is configured to prepare the medical fluid by selectively controlling the flow of the diluent and the drug into the consumable 120, and then the medical fluid can flow to the delivery bag 180. For example, the formulation station 102 can be configured to selectively control one or more valves or pumps to control the flow of fluid from fluid sources (such as diluent vials and / or drug vials) to the consumable 120 stored within the chamber 110.

[0054] In some embodiments, the consumable 120 is disposed within the chamber 110 and is coupled to one or more vials. For example, the consumable 120 can 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 can be in fluid communication with the first vial 140 and the second vial 160. The consumable 120 can be substantially airtight.

[0055] The chamber 110 can include a near sidewall 113, a far sidewall 115, sidewalls 117, and a top wall 119. The sidewalls 117 can be disposed between the near sidewall 113 and the far sidewall 115 such that the sidewalls 117 connect the near sidewall 113 to the far sidewall 115. The sidewalls 117 can extend most of the perimeter of the chamber 110. In some embodiments, the top wall 119 extends between the near sidewall 113 and the far sidewall 115. The top wall 119 can extend from one end of the sidewalls 117 to the other end of the sidewalls 117. For example, the sidewalls 117 can be substantially semi-circular, and the top wall 119 can be connected to the ends of the sidewalls 117. In some embodiments, the top wall 119 includes a slot 121. The slot 121 can be configured to receive the consumable 120. For example, the consumable 120 can be inserted through the slot 121 to place the consumable 120 within the chamber 110. In some embodiments, the slot 121 secures the consumable 120 in place within the chamber 110. The slot 121 can be configured to couple to a sealing element 128 of the consumable 120 to secure the consumable within the slot 121. The slot 121 can allow the consumable 120 to be secured within the chamber 110 and provide an airtight seal between the consumable 120 and the chamber 110. In other words, when the consumable 120 is set to pass through the slot 121 and into the chamber 110, the slot 121 can form an airtight seal with the sealing element 128.

[0056] In some embodiments, the slot 121 is disposed near the distal sidewall 115. When the consumable 120 is disposed within the chamber 110, the slot 121 disposed on the distal sidewall 115 positions the consumable 120 near the distal sidewall 115. In some embodiments, when the consumable 120 is disposed within the chamber 110, the consumable 120 can be near the sidewall 117 and the distal sidewall 115. For example, the perimeter of the consumable 120 can be substantially parallel to the sidewall 117 and can be disposed near the sidewall 117. In some embodiments, the perimeter profile of the consumable 120 corresponds to the profile of the sidewall 117.

[0057] In some embodiments, the chamber 110 includes one or more valves or pumps (e.g., valves 109a, 109b, 109c) configured to control the fluid flow into and out of the consumable 120. For example, valve 109a can be controlled by motor 108a and can be configured to control the fluid flow into and out of the consumable 120 from the first vial 140. Valve 109b can be controlled by motor 108b and can be configured to control the fluid flow from the consumable 120 (e.g., through port 126) via the delivery line 170 to the delivery bag 180. Valve 109c can be controlled by motor 108c and can be configured to control the fluid flow into and out of the consumable 120 from the second vial 160. Each of the valves 109a, 109b, and 109c has a corresponding motor 108a, 108b, 108c that controls the valve as described in detail below.

[0058] In some embodiments, the formulation station 102 includes a rotation device 107 and a pressure device 106. The rotation device 107 can include a motor and can be configured to rotate the chamber 110 relative to the formulation station 102. For example, the rotation device 107 can be coupled to the chamber 110 and configured to rotate 360 degrees relative to the formulation station 102 such that the chamber 110 rotates relative to the formulation station 102. In some embodiments, the rotation device 107 allows the chamber 110 to rotate 360 degrees relative to the formulation station 102. For example, the chamber 110 can have a baseline position (e.g., 0 degrees) and can be rotated from the baseline position by the rotation device 107. In some embodiments, the baseline position of the chamber 110 positions the fluid within the bladder 130 of the consumable 120 away from the seal element 128 and / or the vial(s) coupled to the consumable 120 due to gravity. For example, when the chamber 110 is in the baseline position, any fluid disposed within the consumable 120 is furthest from the seal element 128, any ports, or any vials coupled to the consumable 120.

[0059] The rotating device 107 can be disposed close to the pressure device 106. In some embodiments, the pressure device 106 is disposed within or passes through the rotating device 107. For example, the rotating device 107 can be coupled to the chamber 110, and the pressure device 106 can be disposed within and along the rotating device 107.

[0060] In some embodiments, the pressure device 106 controls the pressure within the chamber 110. The pressure device 106 can include an air tube or passage coupled to the chamber 110 and configured to add air to or remove air from within the chamber 110 to increase or decrease the pressure within the chamber 110. In some embodiments, the pressure device 106 is configured to remove all of the air formed within the chamber 110 to create a vacuum within the chamber 110. The pressure device 106 can be coupled to the chamber 110 such that the pressure device 106 forms an airtight seal with the chamber 110 to allow a vacuum to be created within the chamber 110. The creation of a vacuum within the chamber 110 can cause a fluid (such as air or liquid) to be driven into a bladder (such as bladder 130) disposed within the chamber 110. For example, the creation of a vacuum within the chamber 110 can cause air to flow into the consumable 120. The vacuum can be removed from the chamber 110 to keep the bladder filled with fluid. In other words, the vacuum can be used to drive a fluid into a bladder disposed within the chamber 110.

[0061] In some embodiments, the formulation station 102 includes an extrusion device 105. The extrusion device 105 can be a linear actuator and can include an extrusion surface 112. The extrusion device 105 can be disposed close to the rotating device 107 and / or the pressure device 106. In some embodiments, the extrusion surface 112 is disposed within the chamber 110. The extrusion device 105 is configured to extend and retract the extrusion surface 112. For example, the extrusion device 105 and the extrusion surface 112 can 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 a position where the extrusion surface 112 is between the initial position and the fully extended position. In the initial position, the extrusion surface 112 is fully retracted, thereby forming the inner surface of the chamber 110.

[0062] The extrusion surface 112 can extend from an initial position into the chamber 110. For example, when the extrusion surface 112 is in the initial position, the extrusion surface 112 can be substantially flush with the proximal sidewall 113. In some embodiments, when the extrusion surface 112 is in the initial position, the extrusion surface 112 contacts or is close to the proximal sidewall 113. In some embodiments, the extrusion device 105 includes a rod 104. The rod 104 can be configured to couple the extrusion surface 112 to the motor of the extrusion device 105. For example, an extension of the rod 104 can cause the extrusion surface 112 to extend from the initial position to a fully extended position.

[0063] The extrusion device 105 can be configured to extend the extrusion surface 112 toward the distal sidewall 115. For example, in the initial position, the extrusion surface 112 can abut or can be close to the proximal sidewall 113 as compared to the distal sidewall 115, and in a partially extended position, the extrusion surface 112 can extend away from the proximal sidewall 115 such that the extrusion surface is disposed between the proximal sidewall 113 and the distal sidewall 115. In some embodiments, when the extrusion surface 112 is in the partially extended position, the extrusion surface 112 is closer to the distal sidewall 115 as compared to when the extrusion surface 112 is in the initial position. When the extrusion surface 112 is in the fully extended position, the extrusion surface 112 can abut the consumable 120 such that the consumable 120 has no fluid. The extrusion surface 112 in the fully extended position causes the extrusion surface 112 to press the consumable 120 against the distal sidewall 115. As described below, since the consumable 120 is pressed against the extrusion surface 112 and the distal sidewall 115, the extrusion surface 112 in the fully extended position causes fluid to flow out of the consumable 120.

[0064] The chamber 110 can include an opening 103 that permits fluid communication between the chamber 110 and the extrusion device 107. The opening 103 can be disposed on the proximal sidewall 113. When the extrusion device 112 is in the initial position, the extrusion surface 112 can substantially seal the opening 103. As the extrusion surface 112 extends toward the distal sidewall 115, the extrusion surface 112 can move away from the opening 103 such that the opening 103 is no longer sealed by the extrusion surface 112. In some embodiments, the extrusion device 107 is in fluid communication with the chamber 110 via the opening 103 such that a vacuum applied to the chamber 110 causes the vacuum to be applied to the extrusion device 107.

[0065] Figure 2A is in accordance with various aspects of the present disclosure Figure 1A front view of a consumable of a formulation platform. Figure 2B is in accordance with various aspects of the present disclosure Figure 2A perspective side view of a consumable.

[0066] Reference Figures 2A - 2B, the consumable 120 can include a sealing element 128 and a bladder 130. The bladder 130 can be coupled to the sealing element 128. In some embodiments, the bladder 130 is heat-sealed to the sealing element 128 such that the consumable 120 remains substantially airtight. The consumable 120 can include ports 122, 124, 126. In some embodiments, the ports 122, 124, 126 are configured to allow fluid to flow into and out of the bladder 130. Each of the ports 122, 124, and 126 can be disposed on the sealing element 128. The consumable 120 can be composed of plastic or polymer. In some embodiments, the sealing element 128 is made of rigid plastic, while the bladder 130 is made of plastic film. The sealing element 128 can be coupled to the bladder 130 such that the consumable 120 is airtight.

[0067] The port 122 and the port 124 can be coupled to a fluid source. For example, the port 122 can be coupled to a first vial 140, and the port 124 can be coupled to a second vial 160. The port 122 and the port 124 can respectively include needles 122a and 124a. The needle 122a can extend from the port 122, and the needle 124a can extend from the port 124. The needles 122a and 124a can be configured to extend into the fluid vials when the fluid vials are respectively coupled to the port 122 and the port 124. The needles 122a and 124a can protrude from the sealing element 128. In use, the fluid source is coupled to the port 122 and / or the port 124, and the needles 122a and / or 124a extend from the port 122 and / or 124 into the fluid source. In some embodiments, the ports 122, 124, 126 include any type of coupling mechanism to allow the fluid source to be coupled to the ports 122, 124, 126. For example, the ports 122, 124, 126 can each include a connection interface to allow optimization and simplification between the ports 122, 124, 126 and the fluid source.

[0068] Port 126 can 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 that is configured to allow fluid to flow from the bladder 130 to the delivery bag 180 and not allow fluid to flow from the delivery bag 180 to the bladder 130. Alternatively, port 126 is a two-way valve that allows fluid to flow into and out of the delivery bag 180 and the bladder 130. In some embodiments, the axis of port 126 is arranged perpendicular to the axis of port 122 and / or port 124. For example, the axis extending through port 122 and / or 124 can extend into the bladder 130 and can be parallel to the bladder 130. The axis extending through port 126 can be perpendicular to the bladder 130 and parallel to the plane of the seal element 128. In some embodiments, the plane extending through at least most of the bladder 130 is substantially perpendicular to the plane extending through at least most of the seal element 128.

[0069] In some embodiments, the consumable 120 includes flow paths 123, 127, and 125 that extend from ports 122, 126, and 124, respectively, into the bladder 130. Each of the flow paths 123, 127, and 125 can be created via a heat-sealed portion of the bladder 130. For example, portions of the bladder 130 near ports 122, 124, 126 and near the seal element 128 can be heat-sealed to create the flow paths 123, 127, and 125. Flow path 123 can extend from port 122, flow path 127 can extend from port 126, and flow path 125 can extend from port 124. Flow paths 123, 127, and 125 can direct fluid to flow into and out of the bladder 130 from ports 122, 126, and 124, respectively. In some embodiments, flow path 123 and flow path 125 are inlet flow paths that direct fluid from a fluid source to the bladder 130, while flow path 127 is an outlet flow path that directs fluid from the bladder 130 to a fluid container (e.g., the delivery bag 180).

[0070] In some embodiments, valves 109a, 109b, 109c are configured to control the flow of fluid (e.g., gas or liquid) through flow paths 123, 127, and 125, respectively. Valve 109a may be in an open position to allow fluid to flow through flow path 123. Valve 109a in a closed position may seal flow path 123 to prevent fluid from flowing through flow path 123 and into or out of bladder 130. Valve 109b may be in an open position to allow fluid to flow through flow path 127. Valve 109b in a closed position may seal flow path 127 to prevent fluid from flowing through flow path 127 and into or out of bladder 130. Valve 109c may be in an open position to allow fluid to flow through flow path 125. Valve 109c in a closed position may seal flow path 125 to prevent fluid from flowing through flow path 125 and into or out of bladder 130.

[0071] In some embodiments, one or more of valves 109a, 109b, 109c are configured to control air flowing into bladder 130. For example, valve 109a and / or valve 109c may draw air into bladder 130 before attaching vial 140 and / or vial 160. In some embodiments, air is drawn into bladder 130 because squeezing device 107 creates a vacuum within chamber 110. For example, squeezing device 107 may create a vacuum within chamber 110 such that air flows into bladder 130 through one or more of valves 109a, 109b, 109c, causing bladder 130 to expand.

[0072] Valves 109a, 109b, 109c may be solenoid valves or plungers configured to extend and retract to control flow through flow paths 123, 127, and 125. For example, valves 109a, 109b, 109c may extend outward to seal flow paths 123, 127, and 125, respectively, and may retract inward to open flow paths 123, 127, and 125, respectively, to allow fluid to flow through flow paths 123, 127, and 125. In some embodiments, motors 108a, 108b, 108c and / or valves 109a, 109b, 109c extend into chamber 110. For example, motors 108a, 108b, 108c and / or valves 109a, 109b, 109c may extend into chamber 110 such that when consumable 120 is disposed within chamber 110, motors 108a, 108b, 108c and / or valves 109a, 109b, 109c are close to consumable 120.

[0073] Valves 109a, 109b, 109c may be coupled to a microcontroller disposed within the formulation station 102. The microcontroller may be configured to control the extension and retraction of valves 109a, 109b, 109c. In some embodiments, the formulation station 102 is configured to operate or undergo a predetermined sequence of steps (e.g., rotation of the chamber 110, actuation of the pressure device 105 and / or the extrusion device 107) based on a program executed by the microcontroller.

[0074] In some embodiments, the bladder 130 includes an interior space 132. The interior space 132 may be configured to be filled with fluid when fluid enters the bladder 130 via ports 122, 124, and / or 126. In some embodiments, the interior space 132 is formed by heat-sealing a portion of the bladder 130. The interior space 132 may be a defined portion of the bladder 130 configured to expand and contract. For example, the interior space 132 may expand when the bladder 130 receives fluid and may contract when fluid exits the bladder 130. The interior space 132 and the bladder 130 may be substantially airtight. In some embodiments, the bladder 130 is composed of two layers of plastic film sealed together along its perimeter to form an airtight bladder. When the bladder 130 is substantially contracted such that there is substantially no fluid in the bladder 130, the two plastic films forming the bladder 130 may contact. When the bladder 130 receives and is filled with fluid, the two plastic films may be spaced apart. The amount of fluid that the bladder 130 can hold depends on the size of the interior space 132. For example, the larger the volume of the interior space 132, the larger the volume of fluid that the bladder 130 can hold.

[0075] Figure 3A is in accordance with various aspects of the present disclosure Figure 1A of the formulation platform, with the extrusion device in an initial position. Figure 3B is in accordance with various aspects of the present disclosure Figure 1A of the formulation platform, with the extrusion device in a partially extended position. Figure 3C is in accordance with various aspects of the present disclosure Figure 1A of the formulation platform, with the extrusion device in a fully extended position.

[0076] Referring Figures 3A - 3C , the extrusion 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 extrusion device 105 retracts the extrusion surface 112 such that the extrusion surface 112 is disposed adjacent to the proximal side wall 113. In the initial position, the extrusion surface 112 may be disposed within the wall 113 or may abut the wall. When the extrusion surface 112 transitions from the initial position to a partially extended position, the extrusion device 105 may extend the extrusion surface 112 toward the distal side wall 115.

[0077] When the extrusion surface 112 is between the initial position and the fully extended position, the extrusion surface 112 may be in a partially extended position. In some embodiments, as Figure 3B shown, when the extrusion surface 112 is in the partially extended position and the internal space 132 of the bladder 130 is at least partially filled with fluid, the extrusion surface 112 abuts or contacts the bladder 130. For example, the bladder 130 may have received fluid from a fluid source (e.g., the first vial 140 and / or the second vial 160) such that the volume of the internal space 132 expands. The extrusion surface 112 may be in the partially extended position and may be disposed adjacent to the bladder 130 such that the internal space 132 expands to contact the extrusion surface 112.

[0078] The extrusion surface 112 may be configured to prevent the internal space 132 of the bladder 130 from overexpanding. For example, the extrusion surface 112 may be configured to provide an expansion limit for the bladder 130 (e.g., the internal space 132). The extrusion surface 112 may be positioned adjacent to the bladder 130 such that when the internal space 132 expands, it contacts the extrusion surface 112 and thus cannot continue to expand, thereby restricting further fluid entry into the internal space 132. In some embodiments, the user may set a specific position of the extrusion surface 112 relative to the bladder 130 to control the expansion limit of the internal space 132 and thus control the volume of fluid received and retained by the bladder 130.

[0079] In some embodiments, as Figure 3C shown, the extrusion surface 112 may be in the fully extended position such that when there is substantially no fluid in the internal space 132, the extrusion surface 112 abuts the bladder 130. The extrusion device 105 may transition the extrusion surface 112 from the partially extended position ( Figure 3B ) to the fully extended position ( Figure 3C ). In some embodiments, the extrusion surface 112 extending to the fully extended position causes the extrusion surface 112 to press against the bladder 130, thereby causing the internal space 132 to contract and thus driving fluid out of the bladder 130. For example, the extrusion surface 112 may transition to the fully extended position to cause the extrusion surface 112 to press against the bladder 130, thereby causing the fluid within the internal space 132 to flow out of the bladder 130 and leaving the internal space 132 substantially empty or without fluid.

[0080] In some embodiments, the formulation station 102 is configured to draw fluid into the bladder 130 of the consumable 120 such that the internal space 132 is filled with fluid. For example, when the consumable 120 is disposed within the chamber 110, the consumable 120 may substantially seal the chamber 110. The valves 109a, 109b, 109c may be moved to an extended position to respectively seal the flow paths 123, 127, and 125. When the valves 109a, 109b, 109c are extended, they may press against the flow paths 123, 127, and 125 respectively to seal them. As described above, when the valves 109a, 109b, 109c are retracted, the flow paths 123, 127, and 125 are respectively opened and freely permit fluid or gas to flow into and out of the bladder 130.

[0081] To draw fluid into the internal space 132 of the bladder 130, the desired flow path among the outflow flow paths 123, 127, and 125 is opened via a corresponding valve (e.g., valves 109a, 109b, 109c). The remaining flow paths may be closed. For example, valve 109a may be retracted, and valves 109b and 109c may be extended, such that flow path 123 is opened and flow paths 127 and 125 are closed. The opening of flow path 123 may permit fluid to flow into the internal space 132 only via flow path 123 and port 122.

[0082] In some embodiments, a vacuum is applied to the chamber 110, which causes fluid to be drawn into the bladder 130 via port 122 and flow path 123. For example, the pressure device 106 may create a vacuum within the chamber 110 by removing all of the air within the chamber 110. The creation of a vacuum within the chamber 110 may cause the chamber 110 and the bladder 130 of the consumable 120 to be at a lower pressure than the fluid source (e.g., the first vial 140 and / or the second vial 160), such that fluid flows from the fluid source into the internal space 132 of the bladder 130.

[0083] In some embodiments, to control the volume of fluid drawn into the internal space 132 of the bladder 130, the squeezing device 105 extends the squeezing surface 112 such that the squeezing surface 112 is positioned close to the bladder 130 to create a dilation limit (e.g., Figure 3B ). The position of the squeezing surface 112 and the specific parameters of the vacuum created in the chamber 110 may be related to the volume amount expected to flow in and fill the internal space 132. In some embodiments, the formulation platform 100 uses this correlation to adjust the position of the squeezing surface 112 and the creation of the vacuum within the chamber 110 until the desired volume is drawn into the internal space 132 of the bladder 130.

[0084] In some embodiments, to push or expel fluid from the interior space 132 of the bladder 130, the desired flow path among the outflow flow paths 123, 127, and 125 is opened via a corresponding valve (e.g., valves 109a, 109b, 109c). The remaining flow paths can be closed. For example, valve 109b can be retracted, and valves 109a and 109c can be extended such that flow path 127 is opened and flow paths 123 and 125 are closed. Opening flow path 127 can allow fluid to flow out of interior space 132 only via flow path 127 and port 126. In some embodiments, to push or expel fluid from interior space 132, the squeezing device 105 extends the squeezing surface 112 against the bladder 130 (e.g., to a fully extended position) to apply a force to interior space 132, causing interior space 132 to contract, thereby forcing fluid out of the opened flow path (e.g., flow path 127) and out of the port (e.g., port 126) that is in fluid communication with one flow path. In some embodiments, the volume of fluid discharged or removed from the interior space 132 of the bladder 130 is associated with the change in position of the squeezing surface 112.

[0085] Figure 4A is according to various aspects of the present disclosure Figure 1A front view of a formulation platform, where the formulation platform is in use. Figure 4B is according to various aspects of the present disclosure Figure 1A front view of a formulation platform, where the formulation platform is in use. Figure 4C is according to various aspects of the present disclosure Figure 1A front view of a formulation platform, where the formulation platform is in use. Figure 4D is according to various aspects of the present disclosure Figure 1A front view of a formulation platform, where the formulation platform is in use.

[0086] Referring Figures 4A - 4D to, the formulation platform 100 can be configured to reconstitute a drug vial, such as the second vial 160. For example, the formulation platform 100 can allow adjustment of the ratio of diluent and drug (e.g., medication) within the vial or fluid container.

[0087] In some embodiments, the consumable 120 is inserted through the slot 121 of the chamber 110 to secure the consumable 120 within the chamber 110. The user can interact with the user interface 190 to select the desired routine or program to run for the formulation platform 100 to achieve the desired result. For example, the user can interact with the user interface 190 to select a route intended to reconstitute a vial. The formulation platform 100 can then undergo an automatic or semi-automatic process to reconstitute the vial.

[0088] Reconstitution of the vial (e.g., the second vial 160) requires fluid to flow from one or more vials into the bladder 130 and from the bladder 130 into one or more vials. The reconstitution fluid can then be transferred from the bladder 130 to one or more vials and / or a storage container (e.g., the delivery bag 180).

[0089] In some embodiments, one or more valves 109a, 109b, 109c are closed to close one or more flow paths 123, 127, and 125. For example, valve 109b and valve 109c can be closed while valve 109a is open. This allows fluid to flow into port 122 and through flow path 123 while preventing fluid from flowing into ports 126 and 124 and through flow paths 127 and 125, respectively. A vacuum can be applied within chamber 110 by pressure device 106 such that a volume of air is drawn into the interior space 132 of the bladder 130. The vacuum can then be removed from chamber 110.

[0090] In some embodiments, the first vial 140 is coupled to port 122 and the second vial 160 is coupled to port 124. The first vial 140 can be a fluid source of a diluent fluid and the second vial 160 can be a fluid source of a medicament, such as a lyophilized medicament source. The delivery bag 180 can be disposed on the storage area 185 of the formulation station 102 and can be coupled to port 126 via delivery tubing 170.

[0091] The formulation station 102 can be configured to perform a series of push - pull routines or operations to transfer fluid between the first vial 140 and / or the second vial 160 and the bladder 130. For example, the formulation station 102 can open one or more valves (e.g., valves 109a, 109b, 109c) and rotate chamber 110 to allow fluid to flow between the first vial 140 and / or the second vial 160 and the bladder 130.

[0092] In some embodiments, due to the vacuum generated within chamber 110, the interior space 132 includes a volume of air, which causes air to flow into the bladder 130. The squeezing surface 112 can be extended by the squeezing device 105 to apply pressure of the squeezing surface 112 to the partially expanded interior air space 132. Since valve 109a is open, air from the interior space 132 can be expelled from the bladder 130 via flow path 123 and through port 122 into the first vial 140. Fluid from the first vial 140, such as a diluent fluid, can be driven from the first vial 140 through port 122 and flow path 123 into the interior space 132 as air is expelled from the bladder 130 and into the first vial 140, thereby causing fluid to be transferred from the first vial 140 and into the bladder 130. In other words, as Figure 4AAs shown, air can be driven from the internal space 132 into the first vial 140 such that fluid is driven from the first vial 140 into the internal space 132.

[0093] Reference Figure 4B , the diluent fluid from the first vial 140 can be transferred from the first vial 140 and disposed within the internal space 132, and subsequently transferred from the internal space 132 to the second vial 160. For example, the chamber 110 can be rotated or inverted by the rotating device 107 such that the chamber 110 is in an inverted position (e.g., rotated 180 degrees) from the baseline position. Before the chamber 110 is rotated or inverted, the valve 109c can be opened, and the valves 109a and 109b can be closed such that the second vial 160 is in fluid communication with the bladder 130 through the port 124 and the flow path 125, and the first vial 140 is no longer in fluid communication with the bladder 130.

[0094] Once the chamber 110 has been inverted or rotated by approximately 180 degrees, the diluent fluid can flow from the internal space 132 through the flow path 125 and the port 124 and into the second vial 160. The second vial 160 can contain a medicament or drug. The medicament or drug disposed within the second vial 160 can be configured to dissolve in the diluent fluid, such as the diluent fluid disposed within the first vial 140. In some embodiments, a vacuum is created within the chamber 110 and / or the squeezing device 105 causes the squeezing surface 112 to press against the bladder 130 and retract from the pressed bladder 130 such that the diluent fluid within the bladder 130 flows into the second vial 160.

[0095] In some embodiments, the transfer of the diluent fluid from the internal space 132 to the second vial 160 causes the air that has been transferred to the first vial 140 to be transferred back into the internal space 132, such that the second vial 160 at least partially includes the diluent fluid and the internal space 132 at least partially includes air (e.g., from the first vial 140). The transfer of the diluent fluid from the internal space 132 to the second vial 160 can cause the air displaced by the diluent fluid from the second vial 160 to be transferred into the internal space 132, such that the second vial 160 at least partially contains the diluent fluid and the internal space 132 at least partially contains air (e.g., from the second vial 160).

[0096] In some embodiments, multiple inversions and / or rotations are required to completely transfer the diluent fluid from the internal space 132 to the second vial 160. The delivery tube 170 may be coupled to the consumable 120 and configured to allow the chamber 110 and the consumable 120 to be rotated multiple times without being damaged. For example, the delivery tube 170 may have a predetermined length that allows the chamber 110 and the consumable 120 to be rotated multiple times without the delivery tube 170 being distorted or damaged. In some embodiments, the delivery tube 170 includes a pre-twisted section to help minimize unwanted twisting and damage of the delivery tube 170.

[0097] Reference 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 oscillate 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. Since the second vial 160 is coupled to the consumable 120 disposed within the chamber 110, the rotation or oscillation of the chamber 110 may cause the substances within the second vial 160 to be shaken or mixed. For example, the oscillation of the chamber 110 may cause the mixing of the diluent fluid and the drug within the second vial 160, such that the drug is completely dissolved in the diluent fluid and a recombined fluid is produced. In some embodiments, the valves 109a, 109b, 109c are closed to prevent the recombined fluid from flowing from the second vial 160 into the bladder 130 during the oscillation of the chamber 110.

[0098] When the chamber 110 is at 180 degrees relative to the baseline position and after the diluent fluid has flowed into the second vial 160, the rotating device 107 may oscillate or shake the chamber 110 from between 180 degrees and 270 degrees to between 180 degrees and 90 degrees. In some embodiments, the rotating device 107 swings the chamber 110 from any position between 0 degrees and 360 degrees relative to the baseline position of the chamber 110 such that the drug is completely dissolved in the diluent fluid within the second vial 160 and a recombined fluid is produced.

[0099] Refer to Figure 4D, when the chamber 110 oscillates and the drug is dissolved in the diluent fluid within the second vial 160, the chamber 110 can return to the baseline position. When the chamber 110 returns to the baseline position, the valve 109c can open, allowing the reconstituted fluid from the second vial 160 to flow into the bladder 130 via the port 124 and the flow path 125. The air from the internal space 132 can be displaced by the reconstituted fluid and can flow into the second vial 160. In some embodiments, a vacuum is created within the chamber 110 and / or the squeezing device 105 causes the squeezing surface 112 to press against the bladder 130 and retract from the pressed bladder 130, so that the reconstituted fluid within the second vial 160 flows into the bladder 130.

[0100] Figure 5 is in accordance with various aspects of the present disclosure Figure 1A front perspective view of a formulation platform, where the formulation platform is in use.

[0101] Referring to Figure 5 , the reconstituted fluid disposed within the bladder 130 can be delivered to the delivery bag 180 via the delivery tube 170. For example, when the reconstituted fluid is transferred to the internal space 132, the valve 109c can extend to close the flow path 125 and prevent fluid from flowing through the port 124 and the flow path 125. The valve 109b can retract to open the flow path 127, allowing fluid to flow from the internal space 132 through the flow path 127 and the port 126 to the delivery bag 180 that is connected to the port 126 via the delivery fitting. In some embodiments, a vacuum is created within the chamber 110 and / or the squeezing device 105 causes the squeezing surface 112 to press against the bladder 130 and retract from the pressed bladder 130, so that the reconstituted fluid within the internal space 132 flows into the delivery bag 180 via the delivery fitting 170.

[0102] In some embodiments, the chamber 110 is rotated before transferring the reconstituted fluid to the delivery bag 180. For example, the chamber 110 can be rotated approximately 180 degrees from the baseline position, and the reconstituted fluid can be transferred from the internal space 132 to the delivery bag 180. Inverting the chamber 110 before transferring the reconstituted fluid to the delivery bag 180 can prevent or minimize air from entering the delivery bag 108.

[0103] In some embodiments, the delivery tube 170 includes a first end 171 coupled to the consumable 120 and a second end 173 coupled to the delivery bag 180. The second end 173 may include a male Luer fitting for coupling the delivery tube 170 to the delivery bag 180. In some embodiments, to facilitate handling of hazardous drugs, the second end 173 is provided with a leak-proof or non-leaking drug transfer device, such as a closed system drug transfer device (CSTD), or is engaged with the drug transfer device. For example, if one or more of the first vial 140 and / or the second vial 160 includes a hazardous material, to prevent injury to individuals around the compounding platform 100, the second end 173 may include a leak-proof or non-leaking drug transfer device to prevent leakage of the hazardous material when the delivery tube 170 is separated from the delivery bag 180.

[0104] In some embodiments, the second end 173 includes a safety needle for hazardous drugs. For example, the second end 173 may include a round-tip safety needle for protecting healthcare workers during separation of the second end 173 from the delivery bag 180. In some embodiments, the round-tip safety needle includes a spring and a protective round tip disposed on the needle. The spring may be extended such that the protective round tip covers the end of the needle. The protective round tip may be retracted by applying a force to expose the needle. Once the force is removed, the protective round tip may extend to cover the end of the needle due to the spring being biased to extend.

[0105] In some embodiments, the consumable 120 is disposable. For example, the consumable 120 may be for single use to allow a user to discard the consumable 120 upon completion of a desired task (e.g., generating a reconstitution fluid and transferring the reconstitution fluid to the delivery bag 180). In some embodiments, when the second end 173 is separated 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. If the drug or medication initially stored in the second vial 160 is hazardous, the consumable 120 may be discarded along with the first vial 140, the second vial 160, and / or the delivery tube 170. In some embodiments, when transferring the reconstitution fluid from the second vial 160 to the bladder 130, the consumable 120 may be removed from the chamber 110 and stored in a safe location for later use.

[0106] In some embodiments, the formulation platform 100 is configured to produce a reconstitution fluid for transfer to a delivery bag 180. For example, using a series of extensions and retractions of valves 109a, 109b, 109c, with the chamber 110 in the baseline position, diluent fluid can be transferred from the first vial 140 to the internal space 132, and a drug from the second vial 160 can 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. When transferring the diluent fluid and the drug to the internal space 132, the chamber 110 can be rotated and / or oscillated by the rotation device 107 to dissolve the drug in the diluent fluid, thereby producing a reconstitution fluid within the internal space 132.

[0107] In some embodiments, when producing the reconstitution fluid, the reconstitution fluid can be transferred to the delivery bag 180 via the delivery tubing 170. Before transferring the reconstitution fluid to the delivery bag 180, the chamber 110 can be inverted to prevent air from being transferred to the delivery bag 180.

[0108] In some embodiments, the delivery bag 180 is empty before transferring fluid from the bladder 130 to the delivery bag 180. Alternatively, the delivery bag 180 can include a fluid, such as a saline solution, that is configured to mix with the reconstitution fluid when the reconstitution fluid is transferred from the bladder 130 to the delivery bag 180.

[0109] The disclosure described herein includes at least the following items:

[0110] Item 1: A formulation platform, comprising: a formulation station including a user interface configured to receive input from a user and a rotation device; a chamber coupled to the formulation station, wherein the rotation device is coupled to the chamber and configured to rotate the chamber relative to the formulation station; a consumable configured to be disposed within the chamber, the consumable including a plurality of ports and a bladder in fluid communication with the plurality of ports; a first vial removably coupled to the consumable via a first port of the plurality of ports, the first vial including a diluent fluid; a second vial removably coupled to the consumable via a second port of the plurality of ports, the second vial including a drug; and a plurality of valves configured to control fluid flow into and out of the bladder, wherein the plurality of valves correspond to the plurality of ports.

[0111] Item 2: The formulation platform according to Item 1, wherein the consumable includes a sealing element configured to allow communication between the bladder and the plurality of ports.

[0112] Item 3: The formulation platform according to Item 2, wherein the chamber includes a slot, and the consumable is placed through the slot such that the sealing element engages with the slot to fixedly connect the bladder in the chamber.

[0113] Item 4: The formulation platform according to Item 3, wherein when the consumable is inserted through the slot and the sealing element is disposed in the slot, the chamber is airtight.

[0114] Item 5: The formulation platform according to Item 2, wherein the sealing element includes a first port and a second port.

[0115] Item 6: The formulation platform according to Item 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.

[0116] Item 7: The formulation platform according to Item 6, wherein the plurality of valves includes 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.

[0117] Item 8: The formulation platform according to Item 6, wherein when the first vial is coupled to the first port, the first flow path is in fluid communication with the first vial.

[0118] Item 9: The formulation platform according to Item 6, wherein when the second vial is coupled to the second port, the second flow path is in fluid communication with the second vial.

[0119] Item 10: The formulation platform according to Item 1, further comprising:

[0120] A delivery bag removably coupled to the consumable via a third port of the plurality of ports.

[0121] Item 11: The formulation platform according to Item 10, wherein the third port is coupled to a delivery tube that couples the delivery bag to the third port.

[0122] Item 12: The formulation platform according to Item 1, further comprising a pressure device coupled to the chamber, the pressure device being configured to create a vacuum in the chamber.

[0123] Item 13: The formulation platform according to Item 1 further includes an extrusion device, the extrusion device being connected to the chamber, the extrusion device including an extrusion surface disposed within the chamber, the extrusion device having a retracted position and an extended position, wherein the extrusion device is closer to the bladder when in the extended position than when in the retracted position.

[0124] Item 14: The formulation platform according to Item 1, wherein the chamber is a vacuum chamber.

[0125] Item 15: The formulation platform according to Item 1, wherein the first port and the second port allow bidirectional fluid communication.

[0126] Item 16: The formulation platform according to Item 1, wherein the bladder includes an internal space that is in fluid communication with the first vial and the second vial.

[0127] Item 17: The formulation platform according to Item 1 further includes a controller, the controller being disposed within the formulation station and communicatively connected to the user interface, the controller being configured to cause the formulation station to perform a set of operations in response to an input received via the user interface, wherein the set of operations includes one or more of rotation of the chamber, opening of one of the plurality of valves, and generation of a vacuum within the chamber.

[0128] Item 18: The formulation platform according to Item 1, wherein the rotating device rotates the chamber from a baseline position by 0 degrees to 360 degrees relative to the formulation station.

[0129] Article 19: A formulation platform, comprising: a formulation station including a user interface configured to receive input from a user and a rotating device; a chamber coupled to the formulation station and having a slot, wherein the rotating device is coupled to the chamber and rotates the chamber from a baseline position 0 degrees to 360 degrees relative to the formulation station; a consumable configured to be disposed within the chamber, the consumable including a sealing element, a plurality of ports, and a bladder fluidly communicating with the plurality of ports, wherein the chamber includes a slot and the consumable is disposed through the slot such that the sealing element engages the slot to secure the bladder within the chamber; a first vial removably coupled to the consumable via a first port of the plurality of ports, the first vial including a diluent fluid; a second vial removably coupled to the consumable via a second port of the plurality of ports, the second vial including a drug, wherein the bladder includes an interior space fluidly communicating with the first and second vials; a plurality of valves configured to control fluid flow into and out of the bladder, wherein the plurality of valves correspond to the plurality of ports; a pressing device coupled to the chamber, the pressing device including a pressing surface disposed within the chamber, the pressing device having a retracted position and an extended position, wherein the pressing device is closer to the bladder when in the extended position than when in the retracted position; a pressure device coupled to the chamber, the pressure device configured to create a vacuum within the chamber; and a delivery bag removably coupled to the consumable via a third port of the plurality of ports, wherein the bladder includes a first flow path fluidly communicating with the first port and a second flow path communicating with the second port, and the plurality of valves includes a first valve and a second valve, the first valve configured to block flow within the first flow path, and the second valve configured to block flow within the second flow path.

[0130] Article 20: A method of formulating a medical fluid, the method comprising: inserting a consumable through a slot of a chamber to dispose the consumable within the chamber, the consumable including a bladder configured to expand; creating a vacuum within the chamber to cause air to flow into the consumable through a first port; removably coupling a first vial containing a drug fluid to the chamber, the first vial being in fluid communication 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 cause air to flow from the consumable through the first port into the first vial, which causes a predetermined amount of the 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 such that a predetermined amount of the drug fluid flows through the second port to the delivery bag.

[0131] Item 21: A method of reconstituting a medical fluid, the method comprising: creating a vacuum in a chamber that is coupled to a compounding station and includes a consumable having a first port and a second port, wherein creating the vacuum causes air to flow into the consumable and the first port and the second port are in fluid communication with the consumable; removing the vacuum from the chamber and opening a first valve of a plurality of valves to allow air to flow from the consumable into a first vial such that a diluent fluid flows from the first vial through the first port to the consumable, the first vial being coupled to the first port such that when the first valve is open, the first vial is in fluid communication with the consumable; rotating the chamber via a rotating device that couples the chamber to the compounding station such that the chamber is inverted substantially from a baseline position; in response to rotating the chamber, opening a second valve of the plurality of valves to allow the diluent fluid to flow from the consumable to a second vial, the second vial being coupled to the second port such that when the second valve is open, the second vial is in fluid communication with the consumable, the second vial including a drug; oscillating the chamber via the rotating device such that the second vial is oscillated, thereby causing the drug to at least partially dissolve in the diluent fluid within the second vial to produce a reconstituted fluid; and rotating the chamber via the rotating device to the baseline position such that the reconstituted fluid flows from the second vial to the consumable via the second port.

[0132] This disclosure is provided to enable a person having ordinary skill in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Numerous modifications to these aspects will be apparent to a person having ordinary skill in the art, and the general principles defined herein may be applied to other aspects.

[0133] Unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one" but "one or more." Unless otherwise specified, the term "some" means one or more. Masculine pronouns (e.g., his) include feminine and neuter genders (e.g., her and its), and vice versa. The use of headings and subheadings (if any) is for convenience only and does not limit this disclosure.

[0134] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" need not be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0135] Phrases such as "aspect" do not mean that such an aspect is essential to the subject technology or that such an aspect applies to all configurations of the subject technology. The disclosure related to an aspect can apply to all configurations or one or more configurations. An aspect can provide one or more examples. The phrase "an aspect" can refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not mean that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. The disclosure related to an embodiment can apply to all embodiments or one or more embodiments. An embodiment can provide one or more examples. The phrase "an embodiment" can refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not mean that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. The disclosure related to a configuration can apply to all configurations or one or more configurations. A configuration can provide one or more examples. The phrase "such a configuration" can refer to one or more configurations, and vice versa.

[0136] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those set forth in the appended claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they pertain and with the custom of the field to which they belong.

[0137] In one aspect, terms such as "coupled" can refer to direct coupling. In another aspect, terms such as "coupled" can refer to indirect coupling.

[0138] Terms such as "top", "bottom", "front", "rear", etc. as used in this disclosure should be understood to refer to any reference frame and not to the ordinary gravity reference frame. Thus, a top surface, a bottom surface, a front surface, and a rear surface can extend upward, downward, diagonally, or horizontally in the gravity reference frame.

[0139] Various items can be arranged differently (e.g., in a different order or divided in a different way) without departing from the scope of the subject technology. All structural and functional equivalents of the elements of the various aspects described throughout this disclosure are known to those of ordinary skill in the art or will later become known to those of ordinary skill in the art, which are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosure is explicitly recited in the claims. A claim element will not be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase "means" or, in the case of a method claim, using the phrase "step for...". Further, with respect to the scope of the terms "comprising", "having", etc. used, such terms are intended to be inclusive in a manner similar to the term "comprising" as interpreted when used as a transitional term in a claim.

[0140] The title, background art, utility model content, description of the drawings, and abstract of the present disclosure are hereby incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. This application is filed based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and, for the purpose of simplifying the present disclosure, various features are combined together in various embodiments. The disclosed method should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Instead, as reflected in the appended claims, the utility model subject matter lies in less than all of the features of a single disclosed configuration or operation. The following claims are thus incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.

[0141] The claims are not intended to be limited to the aspects described herein, but rather conform to the full scope consistent with the language of the claims and include all legal equivalents. Nevertheless, all claims are not intended to cover subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103, nor should they be construed in such a way.

Claims

1. A formulation platform, characterized in that, It includes: A preparation station, the preparation station including a user interface configured to receive input from a user and a rotating device; A chamber, the chamber being connected to the preparation station, wherein the rotating device is connected to the chamber and configured to rotate the chamber relative to the preparation station; Consumables, the consumables being configured to be disposed within the chamber, the consumables including a plurality of ports and a bladder in fluid communication with the plurality of ports; A first vial removably connected to the consumables via a first port of the plurality of ports, the first vial including a diluent fluid; A second vial removably connected to the consumables via a second port of the plurality of ports, the second vial including a drug; and A plurality of valves configured to control fluid inflow and outflow from the bladder, wherein the plurality of valves correspond to the plurality of ports.

2. The formulation platform according to claim 1, characterized in that, The consumables include a sealing element configured to allow the bladder to communicate with the plurality of ports.

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

4. The formulation platform according to claim 3, wherein When the consumables are inserted through the slot and the sealing element is disposed within the slot, the chamber is airtight.

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

6. The formulation platform according to claim 1, characterized in that, 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 formulation platform according to claim 6, wherein The plurality of valves includes a first valve and a second valve, the first valve being configured to block the flow within the first flow path, and the second valve being configured to block the flow within the second flow path.

8. The formulation platform according to claim 6, characterized in that When the first vial is connected to the first port, the first flow path is in fluid communication with the first vial.

9. The formulation platform according to claim 6, characterized in that, When the second vial is connected to the second port, the second flow path is in fluid communication with the second vial.

10. The formulation platform according to claim 1, characterized in that, It further includes: A delivery bag removably connected to the consumables via a third port of the plurality of ports.

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

12. The formulation platform according to claim 1, characterized in that It further includes: A pressure device connected to the chamber, the pressure device being configured to create a vacuum within the chamber.

13. The formulation platform according to claim 1, wherein It further includes: An extrusion device connected to the chamber, the extrusion device including an extrusion surface disposed within the chamber, the extrusion device having a retracted position and an extended position, wherein the extrusion device is closer to the bladder when in the extended position compared to when in the retracted position.

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

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

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

17. The formulation platform according to claim 1, wherein It further includes: A controller, the controller being disposed within the formulation station and communicatively coupled to the user interface, the controller being configured to cause the formulation station to perform a set of operations in response to an input received via the user interface, wherein the set of operations includes one or more of rotation of the chamber, opening of one of a plurality of valves, and generation of a vacuum within the chamber.

18. The formulation platform according to claim 1, wherein The rotation device rotates the chamber from a baseline position by 0 degrees to 360 degrees relative to the formulation station.

19. A formulation platform, characterized in that, It includes: A formulation station, the formulation station including a user interface configured to receive input from a user and a rotation device; A chamber, the chamber being coupled to the formulation station and having a slot, wherein the rotation device is coupled to the chamber and rotates the chamber from a baseline position by 0 degrees to 360 degrees relative to the formulation station; Consumables, the consumables being configured to be disposed within the chamber, the consumables including a sealing element, a plurality of ports, and a bladder fluidly communicating with the plurality of ports, wherein the chamber includes a slot, and the consumables are disposed through the slot such that the sealing element engages with the slot to secure the bladder within the chamber; A first vial, the first vial being removably coupled to the consumables via a first port of the plurality of ports, the first vial including a diluent fluid; A second vial, the second vial being removably coupled to the consumables via a second port of the plurality of ports, the second vial including a drug, wherein the bladder includes an internal space fluidly communicating with the first vial and the second vial; A plurality of valves, the plurality of valves being configured to control fluid inflow into and outflow from the bladder, wherein the plurality of valves correspond to the plurality of ports; An extrusion device, the extrusion device being coupled to the chamber, the extrusion device including an extrusion surface disposed within the chamber, the extrusion device having a retracted position and an extended position, wherein the extrusion device is closer to the bladder when in the extended position than when in the retracted position; A pressure device, the pressure device being coupled to the chamber, the pressure device being configured to generate a vacuum within the chamber; and A delivery bag, the delivery bag being removably coupled to the consumables via a third port of the plurality of ports, wherein the bladder includes a first flow path fluidly communicating with the first port and a second flow path communicating with the second port, and the plurality of valves includes a first valve and a second valve, the first valve being configured to block flow within the first flow path, and the second valve being configured to block flow within the second flow path.

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