Semi-automatic preparation platform
Through the design of the semi-automatic formulation platform, the fluid is controlled by rotating, extruding and pressure devices, the complex and expensive problems of traditional formulation platforms are solved, and efficient, precise formulation and delivery of parenteral drugs are achieved.
Patent Information
- Application Number
- CN202410859309.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-07-03
- Filing Date
- 2024-06-28
- Publication Date
- 2025-01-03
AI Technical Summary
The traditional parenteral drug formulation platform is complex, expensive and requires a lot of user interaction, resulting in cumbersome and high cost.
A semi-automatic formulation platform is designed, including a formulation station, chamber, consumables and delivery bags, to control the flow and mixing of fluids through rotary devices, extrusion devices and pressure devices to achieve selective mixing and delivery of diluents and drugs.
Simplifies the drug formulation process, reduces operational complexity and cost, improves the accuracy and efficiency of fluid mixing, reduces user interaction, and is suitable for the preparation of medical fluids for infusion.
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Figure CN119235650A_ABST
Abstract
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 treatments often involve infusing a patient with a medical fluid (e.g., saline solution or liquid medication) using an intravenous (IV) catheter that is connected to a fluid source, such as an IV bag, by an arrangement of flexible tubing and fittings. A compounding platform can be used to prepare a parenteral medication for infusion.
[0003] Traditional preparation platforms can be manual or semi-automatic. Traditional preparation platforms require the use of many consumables during the preparation of infusion drugs. In addition, traditional preparation platforms require many steps and / or procedures, which leads to a lot of user interaction. In addition, traditional preparation platforms require expensive components, such as injection pumps and complex consumables, which increase the overall cost of the preparation platform. Summary of the invention
[0004] One or more embodiments of the present disclosure are directed to a dispensing platform, the dispensing platform comprising: a dispensing station, the dispensing station comprising a user interface and a rotating device configured to receive input from a user; a chamber coupled to the dispensing station, wherein the rotating device is coupled to the chamber and configured to rotate the chamber relative to the dispensing station; a consumable configured to be disposed in the chamber, the consumable comprising a plurality of ports and a capsule in fluid communication with the plurality of ports;
[0005] A first vial of a consumable removably coupled to the consumable via a first port among a plurality of ports, the first vial comprising a diluent fluid, a second vial of the consumable removably coupled to the consumable via a second port among the plurality of ports, the second vial comprising 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.
[0006] In some embodiments, the consumable includes a sealing element configured to allow the capsule to communicate with multiple ports. The chamber includes a slot through which the consumable is disposed so that the sealing element engages with the slot to secure the capsule in the chamber. When the consumable is inserted through the slot and the sealing element is disposed in the slot, the chamber is 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 the first port and a second flow path in fluid communication with the second port. The plurality of valves include 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 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 comprises 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 configured to create a vacuum within the chamber.
[0010] In some embodiments, the dispensing platform further comprises an extrusion device coupled to the chamber, the extrusion device comprising 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 capsule when in the extended position than when the extrusion device is 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 for bi-directional fluid communication.
[0013] In some embodiments, the bladder includes an interior space in fluid communication with the first vial and the second vial.
[0014] In some embodiments, the preparation platform also includes a controller disposed within the preparation station and communicatively coupled to the user interface, the controller being configured to cause the preparation station to perform a set of operations in response to 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.
[0015] In some embodiments, the rotation device rotates the chamber from 0 degrees to 360 degrees relative to the compounding station from a baseline position.
[0016] One or more embodiments of the present disclosure relate to a compounding platform, comprising: a compounding station, the compounding station comprising a user interface and a rotating device configured to receive input from a user; a chamber, the chamber being coupled to the compounding station and having a slot, wherein the rotating device is coupled to the chamber and rotates the chamber from a baseline position from 0 degrees to 360 degrees relative to the compounding station; a consumable, the consumable being configured to be disposed in 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 comprises a slot, and the consumable is disposed through the slot so that the sealing element engages with the slot to secure the bladder in the chamber; a first vial, the first vial being removably coupled to the consumable via a first port of the plurality of ports, the first vial comprising a diluent fluid; a second vial, the second vial being removably coupled to the consumable via a second port of the plurality of ports, the second vial comprising a drug, wherein the bladder comprises a sealing element in fluid communication with the first vial and the second vial. The invention relates to an internal space of two vials connected by fluid; a plurality of valves configured to control the flow of fluid into and out of the sac, wherein the plurality of valves correspond to the plurality of ports; an extrusion device connected to the chamber, the extrusion device including an extrusion surface arranged in the chamber, the extrusion device having a retracted position and an extended position, wherein when the extrusion device is in the extended position, the extrusion device is closer to the sac than when the extrusion device is in the retracted position; a pressure device connected to the chamber, the pressure device configured to generate a vacuum in the chamber; and a delivery bag removably connected to the consumable via a third port among the plurality of ports, wherein the sac includes a first flow path connected to the first port fluidly and a second flow path connected to the second port, and the plurality of valves include a first valve and a second valve, the first valve is configured to block the flow in the first flow path, and the second valve is configured to block the flow in the second flow path.
[0017] One or more embodiments of the present disclosure relate to a method for preparing a medical fluid, the method comprising: inserting a consumable through a narrow slot of a chamber to place the consumable in the chamber, the consumable comprising a bladder configured to expand; generating a vacuum in the chamber to allow air to flow into the consumable through a first port; removably connecting a first vial to the chamber, the first vial containing a drug fluid and being fluidly connected to a first port of the consumable when connected to the chamber to allow the drug fluid to flow from the first vial to the bladder; rotating the chamber to allow air to flow from the consumable into the first vial via the first port, thereby causing 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 connected to a delivery bag, such that a predetermined amount of drug fluid flows to the delivery bag through the second port.
[0018] One or more embodiments of the present disclosure relate to a method for reconstructing a medical fluid, the method comprising: generating a vacuum in a chamber, the chamber being connected to a compounding station and comprising a consumable having a first port and a second port, wherein the generation 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 of a plurality of valves to cause air to flow from the consumable into a first vial, causing a diluent fluid to flow from the first vial through the first port to the consumable, the first vial being connected to the first port, so that when the first valve is opened, the first vial is in fluid communication with the consumable; and The rotating device rotates the chamber so that the chamber is substantially inverted from a baseline position; in response to rotating the chamber, a second valve of the plurality of valves is opened to allow the diluent fluid to flow from the consumable to a second vial, the second vial being connected to the second port so that when the second valve is opened, the second vial is in fluid communication with the consumable, the second vial comprising a drug; the chamber is oscillated via the rotating device so 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 reconstitution fluid; and the chamber is rotated to the baseline position via the rotating device so that the reconstitution fluid flows from the second vial to the consumable via the second port.
[0019] It should be understood that, according to the present disclosure, the various structures of the subject technology will become clear to those skilled in the art, wherein the various structures of the subject technology are shown and described by way of illustration. As will be appreciated, the subject technology can have other and different configurations and its several details can be modified in various other aspects, all without departing from the scope of the subject technology. Therefore, the content of the invention, the accompanying drawings and the specific embodiments should be regarded as illustrative and non-restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The accompanying drawings, which are included to provide a further understanding and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of embodiments of the disclosure.
[0021] In the attached figure:
[0022] Figure 1A is a front perspective view of a dispensing platform according to various aspects of the present disclosure.
[0023] Figure 1B According to various aspects of the present disclosure Figure 1A An enlarged front perspective view of the consumables of the dispensing platform.
[0024] Figure 1C According to various aspects of the present disclosure Figure 1A Side view of the preparation platform.
[0025] Figure 2A According to various aspects of the present disclosure Figure 1A Front view of the consumables of the dispensing platform.
[0026] Figure 2B According to various aspects of the present disclosure Figure 2A A perspective side view of the consumables.
[0027] Figure 3A According to various aspects of the present disclosure Figure 1A An enlarged side view of the dispensing platform of FIG. 1 , wherein the extrusion device is in the initial position.
[0028] Figure 3B According to various aspects of the present disclosure Figure 1A An enlarged side view of a dispensing platform of FIG. 1 with the extrusion device in a partially extended position.
[0029] Figure 3C According to various aspects of the present disclosure Figure 1A An enlarged side view of the dispensing platform of FIG. 1 , wherein the extrusion device is in a fully extended position.
[0030] Figure 4A According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use.
[0031] Figure 4B According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use.
[0032] Figure 4C According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use.
[0033] Figure 4D According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use.
[0034] Figure 5 According to various aspects of the present disclosure Figure 1A A front perspective view of a dispensing platform, wherein the dispensing platform is in use. DETAILED DESCRIPTION
[0035] The disclosed formulation platform allows a quantitative amount of fluid to be moved from one or more vials to a final delivery container or bag. The term fluid here can refer to any type of fluid, such as a liquid or a gas. The formulation platform allows the diluent and the drug to be mixed by selectively controlling the flow path of the fluid from the vial to the delivery bag. In some embodiments, the formulation platform controls the ratio of the diluent to the drug so that a user can specify a specific ratio of the diluent to the drug to be delivered to the delivery bag. The delivery bag can be used to store medical fluids that are delivered to a patient, such as via an infusion. The delivery bag can include medical fluids titrated and / or formulated by the formulation platform for delivery to a patient.
[0036] The preparation platform includes a preparation station, consumables and a delivery bag. The consumables are connected to the preparation station so that the preparation station controls the flow of fluid into and out of the consumables. The preparation station may include a chamber configured to receive the consumables. For example, the consumables can be placed in the chamber of the preparation 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 connected to the delivery bag. In some embodiments, the consumables are connected to the delivery bag via a pipe such as a delivery tube.
[0037] The consumable includes one or more ports, including an inlet and an outlet. The port of the consumable is configured to be connected to one or more vials to allow fluid to flow into the consumable from the vial. For example, the consumable may include a sac filled with fluid from the vial connected to the port. The port may allow bidirectional fluid flow. For example, the port may allow fluid to flow into the sac of the consumable and flow out from the sac. The consumable may include a port that allows fluid to flow from the sac to the delivery bag via a delivery tube.
[0038] In some embodiments, the consumable is arranged in a chamber of the preparation station. The preparation station may include a pressure device connected to the chamber. The pressure device may be configured to generate a vacuum in the chamber. The chamber may be a vacuum chamber, and when the consumable is arranged in the chamber, a vacuum may be applied to the bladder. In some embodiments, the consumable is inserted into a sealed chamber in the chamber to allow a vacuum to be applied in the chamber. In addition, the application of a vacuum may be used to control the flow of fluid into the bladder. For example, in order to draw fluid into the bladder, a desired flow path is arranged to be opened via a valve connected to one of the ports of the consumable. Other ports may remain closed. A vacuum is applied to the chamber to draw fluid into the bladder.
[0039] The preparation station includes one or more devices that interact with the consumables and / or the bladder. For example, the preparation station may 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 in the chamber and is configured to push against the bladder of the consumables to prevent the bladder from over-expanding. For example, in order to control the volume of fluid sucked into the bladder, the extrusion device positions the extrusion surface close to the bladder to produce an expansion boundary or restriction. The position of the extrusion surface can be adjusted according to the volume expected to flow into the bladder. The preparation platform can apply a vacuum in the chamber and position the extrusion surface so that the required volume is sucked into the bladder.
[0040] The rotating device is coupled to the chamber and is configured to rotate the chamber. For example, the rotating device can rotate the chamber to allow fluid to flow into the bladder from one or more vials coupled to the consumables with the help of gravity. The rotating device is configured to allow the chamber and the consumables to rotate relative to the compounding station and the delivery bag. In some embodiments, the rotating device allows a rocking or shaking motion of the chamber to allow the fluid in the bladder to mix.
[0041] The preparation station may include one or more valves or pumps coupled to each port. For example, each port of the consumable may have a corresponding valve coupled thereto to control the opening and closing of the port. The valve may control the flow of fluid from the vial coupled to the port into the capsule. The preparation station may include a processor (e.g., a controller), such as a microcontroller, configured to control various aspects and devices of the preparation platform, such as a rotating device and an extruding device.
[0042] The detailed description set forth below is intended to be a description of the various configurations of the subject technology, and is not intended to represent the unique configuration that can practice the subject technology. The specific embodiments include specific details for the purpose of providing a thorough understanding of the subject technology. However, it is clear to those skilled in the art that the subject technology can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid blurring the concept of the subject technology. For ease of understanding, identical components are marked with identical element numbers. Reference numerals may be appended with letter suffixes to indicate individual instances of common elements, and common elements are generally referred to by identical numerals without suffix letters.
[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. The various aspects of the disclosed compounding system can be used in any application where a medical fluid needs to be provided to a patient.
[0044] The disclosed formulation platform overcomes a number of challenges found with certain conventional formulation platforms. One challenge with certain conventional formulation platforms is that certain conventional formulation platforms may be very cumbersome to use or may require expensive components. For example, certain conventional formulation platforms require a lot of user interaction or require expensive components.
[0045]
[0013] Therefore, in accordance with the present disclosure, it would be advantageous to provide a dispensing platform as described herein that allows for improved dispensing of medical fluids.
[0046] Figure 1A is a front perspective view of a dispensing platform according to various aspects of the present disclosure. Figure 1B According to various aspects of the present disclosure Figure 1A An enlarged front perspective view of the consumables of the dispensing platform. Figure 1C According to various aspects of the present disclosure Figure 1A Side view of the preparation platform.
[0047] refer to Figures 1A-1C The preparation platform 100 allows for the preparation of a fluid (e.g., a medical fluid) for delivery to a patient. For example, the preparation 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 preparation platform 100 can prepare a fluid (e.g., a medical fluid) and store the prepared fluid in a container (e.g., a delivery bag 180). The container can be injected into a patient or connected to a patient via one or more catheters or needles.
[0048] 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 preparing 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 may be delivered to a patient. The user interface 190 may receive input from a user and may include a touch screen, a keyboard, buttons, switches, or other input mechanisms.
[0049] 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 can be coupled to the user interface 190 and configured to receive input from the user interface 190 and control one or more other devices or components of the compounding station 102 to prepare the medical fluid.
[0050] In some embodiments, the preparation platform 100 includes a chamber 110. The chamber 110 can be coupled to the preparation station 102. The chamber 110 can be configured to receive a consumable (e.g., consumable 120). The chamber 110 can be a vacuum chamber configured to contain a vacuum when the consumable 120 is placed therein. The chamber 110 can be coupled to the preparation station 102 so that the chamber 110 can rotate relative to the preparation station 102.
[0051] 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 a 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 170 may be removably coupled to the delivery bag 180 and / or the consumable 120.
[0052] In some embodiments, the delivery tube 170 allows the delivery bag 180 to be in fluid communication with the consumables 120. In use, the delivery bag 180 may contain a medical fluid to be delivered to a patient. For example, the delivery bag 180 may include a medical fluid to be infused into the patient using a delivery line. The delivery tube 170 may be configured to be separated from the delivery bag 180. For example, after the storage of the required fluid in the delivery bag 180 is completed via the compounding station 102, the delivery tube 170 may be separated from the delivery bag 180 to allow the delivery bag 180 to be transported to another location for use.
[0053] The medical fluid may be a combination of a diluent and a drug. In some embodiments, the compounding station 100 is configured to prepare the medical fluid by selectively controlling the flow of the diluent and the drug into the consumable 120, which may then flow to 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 from a fluid source (e.g., a diluent vial and / or a drug vial) to the consumable 120 stored in the chamber 110.
[0054] In some embodiments, consumable 120 is disposed within chamber 110 and is coupled to one or more vials. For example, consumable 120 can be coupled to first vial 140 and second vial 160. In some embodiments, first vial 140 is a vial containing a diluent fluid, and second vial 160 is a vial containing a drug (such as a lyophilized drug). Consumable 120 can be in fluid communication with first vial 140 and second vial 160. Consumable 120 can be substantially airtight.
[0055] The chamber 110 may include a proximal wall 113, a distal wall 115, a side wall 117, and a top wall 119. The side wall 117 may be disposed between the proximal wall 113 and the distal wall 115 so that the side wall 117 connects the proximal wall 113 to the distal wall 115. The side wall 117 may extend a majority of the periphery of the chamber 110. In some embodiments, the top wall 119 extends between the proximal wall 113 and the distal wall 115. The top 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 top wall 119 may be connected to the end of the side wall 117. In some embodiments, the top wall 119 includes a slot 121. The slot 121 may be configured to receive a consumable 120. For example, the consumable 120 may be inserted through the slot 121 to place the consumable 120 in 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 be coupled 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 disposed 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 proximate to the distal wall 115. When the consumable 120 is disposed in the chamber 110, the slot 121 disposed on the distal wall 115 allows the consumable 120 to be proximate to the distal wall 115. In some embodiments, when the consumable 120 is disposed in the chamber 110, the consumable 120 may be proximate to the sidewall 117 and the distal wall 115. For example, the perimeter of the consumable 120 may be substantially parallel to the sidewall 117 and may be disposed proximate to the sidewall 117. In some embodiments, the perimeter contour of the consumable 120 corresponds to the contour 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 flow of fluid into and out of the consumable 120. For example, valve 109a can be controlled by motor 108a and can be configured to control the flow of fluid 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 flow of fluid from the consumable 120 (e.g., through port 126) via the transfer line 170 to the transfer bag 180. Valve 109c can be controlled by motor 108c and can be configured to control the flow of fluid into and out of the consumable 120 from the second vial 160. Each valve 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 compounding station 102 includes a rotating device 107 and a pressure 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 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 allows the chamber 110 to rotate 360 degrees relative to the compounding station 102. For example, the chamber 110 may have a baseline position (e.g., 0 degrees) and may be rotated from the baseline position by the rotating device 107. In some embodiments, the baseline position of the chamber 110 causes the fluid within the bladder 130 of the consumable 120 to be disposed relative to 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 baseline position, any fluid disposed within the consumable 120 is farthest from the sealing element 128 , any port, or any vial coupled to the consumable 120 .
[0059] The rotating device 107 may be disposed proximate to the pressure device 106. In some embodiments, the pressure device 106 is disposed 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 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 may include an air tube or channel coupled to the chamber 110 and configured to add or remove air from 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 air formed within the chamber 110 to create a vacuum within the chamber 110. The pressure device 106 may be coupled to the chamber 110 so 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 may cause a fluid (such as air or liquid) to be driven into a bladder (e.g., bladder 130) disposed within the chamber 110. For example, the creation of a vacuum within the chamber 110 may cause air to flow into the consumable 120. The vacuum may be removed from the chamber 110 so that the bladder remains filled with fluid. In other words, a vacuum may be used to drive fluid into a bladder disposed within chamber 110 .
[0061] In some embodiments, the compounding 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 proximate to the rotation 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 ), partially extended position ( Figure 3B ) and 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 to form the inner surface of the chamber 110.
[0062] The extrusion surface 112 can extend from the 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 wall 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 wall 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 a motor of the extrusion device 105. For example, the extension of the rod 104 can extend the extrusion surface 112 from the initial position to the fully extended position.
[0063] The extrusion device 105 can be configured to extend the extrusion face 112 toward the distal wall 115. For example, in the initial position, the extrusion face 112 can abut or can be closer to the proximal wall 113 than the distal wall 115, and in the partially extended position, the extrusion face 112 can extend away from the proximal wall 115 so that the extrusion face is disposed between the proximal wall 113 and the distal wall 115. In some embodiments, when the extrusion face 112 is in the partially extended position, the extrusion face 112 is closer to the distal wall 115 than when the extrusion face 112 is in the initial position. When the extrusion face 112 is in the fully extended position, the extrusion face 112 can abut against the consumable 120 so that the consumable 120 is free of fluid. The extrusion face 112 in the fully extended position causes the extrusion face 112 to press the consumable 120 against the distal wall 115. As described below, the extrusion face 112 in the fully extended position causes fluid to flow out of the consumable 120 as the consumable 120 is pressed against the extrusion face 112 and the distal wall 115 .
[0064] The chamber 110 can include an opening 103 that allows the chamber 110 to be in fluid communication with the extrusion device 107. The opening 103 can be disposed on the proximal wall 113. When the extrusion device 112 is in an initial position, the extrusion face 112 can substantially seal the opening 103. As the extrusion face 112 extends toward the distal wall 115, the extrusion face 112 can move away from the opening 103, such that the opening 103 is no longer sealed by the extrusion face 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 a vacuum to be applied to the extrusion device 107.
[0065] Figure 2A According to various aspects of the present disclosure Figure 1A Front view of the consumables of the dispensing platform. Figure 2B According to various aspects of the present disclosure Figure 2A A perspective side view of the consumables.
[0066] refer to Figure 2A-2B, 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, 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 may be disposed on the sealing element 128. The consumable 120 may be made of plastic or a polymer. In some embodiments, the sealing element 128 is made of hard plastic, and the bladder 130 is made of a plastic film. The sealing element 128 may be coupled to the bladder 130 so that the consumable 120 is airtight.
[0067] Port 122 and port 124 can be connected to a fluid source. For example, port 122 can be connected to a first vial 140, and port 124 can be connected to a second vial 160. Port 122 and port 124 can include needles 122a and 124a, respectively. Needle 122a can extend from port 122, and needle 124a can extend from port 124. Needle 122a and needle 124a can be configured to extend into the vial of fluid when the vial of fluid is connected to port 122 and port 124, respectively. Needle 122a and needle 124a can extend from sealing element 128. In use, a fluid source is connected to port 122 and / or port 124, and needle 122a and / or 124a extend from port 122 and / or 124 into the fluid source. In some embodiments, ports 122, 124, 126 include any type of coupling mechanism to allow a fluid source to be connected to ports 122, 124, 126. For example, the ports 122, 124, 126 may each include a connection interface to allow for optimization and simplification between the ports 122, 124, 126 and a fluid source.
[0068] Port 126 can be configured to couple to delivery tube 170 to allow fluid to flow from bladder 130 to delivery bag 180. In some embodiments, port 126 is a one-way outlet configured to allow fluid to flow from bladder 130 to delivery bag 180, but not to allow fluid to flow from delivery bag 180 to bladder 130. Alternatively, port 126 is a two-way valve that allows access to and from delivery bag 180 and 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 ports 122 and / or 124 can extend into bladder 130 and can be parallel to bladder 130. The axis extending through port 126 can be perpendicular to bladder 130 and parallel to the plane of sealing element 128. In some embodiments, the plane extending through at least a majority of bladder 130 is substantially perpendicular to the plane extending through at least a majority of sealing element 128.
[0069] In some embodiments, consumable 120 includes flow paths 123, 127, and 125 extending from ports 122, 126, and 124, respectively, into bladder 130. Each of flow paths 123, 127, and 125 can be generated via a heat-sealed portion of bladder 130. For example, portions of bladder 130 near ports 122, 124, 126, near sealing element 128 can be heat-sealed to generate 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 guide fluids from ports 122, 126, and 124 into and out of bladder 130, respectively. In some embodiments, flow paths 123 and 125 are inlet flow paths that direct fluid from a fluid source into bladder 130, while flow path 127 is an outlet flow path that directs fluid from bladder 130 to a fluid container (eg, 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 can be in an open position, thereby allowing fluid to flow through flow path 123. Valve 109a in a closed position can seal flow path 123 to prevent fluid from flowing through flow path 123 and into or out of bladder 130. Valve 109b can be in an open position, thereby allowing fluid to flow through flow path 127. Valve 109b in a closed position can seal flow path 127 to prevent fluid from flowing through flow path 127 and into or out of bladder 130. Valve 109c can be in an open position, thereby allowing fluid to flow through flow path 125. Valve 109c in a closed position can 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 the flow of air into bladder 130. For example, valve 109a and / or valve 109c can draw air into bladder 130 before attaching vial 140 and / or vial 160. In some embodiments, air is drawn into bladder 130 because ramming device 107 creates a vacuum within chamber 110. For example, ramming device 107 can create a vacuum within chamber 110, causing air to flow into bladder 130 through one or more valves 109a, 109b, 109c, thereby causing bladder 130 to expand.
[0072] The valves 109a, 109b, 109c may be solenoid valves or plungers configured to extend and retract to control flow through the flow paths 123, 127, and 125. For example, the valves 109a, 109b, 109c may extend outward to seal the flow paths 123, 127, and 125, respectively, and may retract inward to open the flow paths 123, 127, and 125, respectively, thereby allowing fluid to flow through the flow paths 123, 127, and 125. In some embodiments, the motors 108a, 108b, 108c and / or the valves 109a, 109b, 109c extend into the chamber 110. For example, the motors 108a, 108b, 108c and / or the valves 109a, 109b, 109c may extend into the chamber 110 such that the motors 108a, 108b, 108c and / or the valves 109a, 109b, 109c are close to the consumable 120 when the consumable 120 is disposed in the chamber 110.
[0073] The valves 109a, 109b, 109c can be coupled to a microcontroller disposed within the compounding station 102. The microcontroller can be configured to control the extension and retraction of the valves 109a, 109b, 109c. In some embodiments, the compounding station 102 is configured to run or undergo predetermined 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 inner space 132. The inner space 132 can be configured to be filled with fluid when the fluid enters the bladder 130 via ports 122, 124 and / or 126. In some embodiments, the inner space 132 is formed via a portion of the heat-sealed bladder 130. The inner space 132 can be a limited portion of the bladder 130 that is configured to expand and contract. For example, the inner space 132 can expand when the bladder 130 receives the fluid, and can contract when the fluid flows out of the bladder 130. The inner space 132 and the bladder 130 can be basically airtight. In some embodiments, the bladder 130 is composed of two layers of plastic films sealed together along its periphery to form an airtight bladder. When the bladder 130 is basically contracted so that the bladder 130 is substantially free of fluid, the two plastic films constituting the bladder 130 can contact. When the bladder 130 receives and is filled with fluid, the two plastic films can be spaced apart. The amount of fluid that the bladder 130 can contain depends on the size of the internal space 132. For example, the larger the volume of the internal space 132, the larger the volume of the fluid that the bladder 130 can contain.
[0075] Figure 3A According to various aspects of the present disclosure Figure 1A An enlarged side view of the dispensing platform of FIG. 1 , wherein the extrusion device is in the initial position. Figure 3B According to various aspects of the present disclosure Figure 1A An enlarged side view of a dispensing platform of FIG. 1 with the extrusion device in a partially extended position. Figure 3C According to various aspects of the present disclosure Figure 1A An enlarged side view of the dispensing platform of FIG. 1 , wherein the extrusion device is in a fully extended position.
[0076] refer to Figures 3A-3C , the extrusion surface 112 may have an initial position ( Figure 3A ), partially retracted position ( Figure 3B ) and fully extended position ( Figure 3C). In the initial position, the extrusion device 105 retracts the extrusion surface 112 so that the extrusion surface 112 is disposed close to the proximal wall 113. In the initial position, the extrusion surface 112 can be disposed within the wall 113 or can abut the wall. When the extrusion surface 112 transitions from the initial position to the partially extended position, the extrusion device 105 can extend the extrusion surface 112 toward the distal wall 115.
[0077] When the extrusion surface 112 is between the initial position and the fully extended position, the extrusion surface 112 can be in a partially extended position. Figure 3B As shown, when the pressing surface 112 is in a partially extended position and the interior space 132 of the bladder 130 is at least partially filled with fluid, the pressing 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 interior space 132 is expanded. The pressing surface 112 may be in a partially extended position and may be disposed proximate to the bladder 130 such that the interior space 132 is expanded to contact the pressing surface 112.
[0078] The extrusion surface 112 can be configured to prevent the interior space 132 of the bladder 130 from over-expanding. For example, the extrusion surface 112 can be configured to provide an expansion limit (e.g., the interior space 132) of the bladder 130. The extrusion surface 112 can be positioned proximate to the bladder 130 so that when the interior space 132 expands, it contacts the extrusion surface 112 and is thus unable to continue to expand, thereby limiting further fluid from entering the interior space 132. In some embodiments, a user can set a specific position of the extrusion surface 112 relative to the bladder 130 to control the expansion limit of the interior space 132, thereby controlling the volume of fluid received and retained by the bladder 130.
[0079] In some embodiments, Figure 3C As shown, the pressing surface 112 can be in a fully extended position, so that when there is substantially no fluid in the internal space 132, the pressing surface 112 abuts against the bladder 130. The pressing device 105 can move the pressing surface 112 from a 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 interior space 132 to contract and thereby drive the fluid out of the bladder 130. For example, the extrusion surface 112 can be transformed into the fully extended position so that the extrusion surface 112 presses against the bladder 130, thereby causing the fluid in the interior space 132 to flow out of the bladder 130 and leaving the interior space 132 substantially empty or without the presence of fluid.
[0080] In some embodiments, the dispensing station 102 is configured to draw fluid into the bladder 130 of the consumable 120 so that the interior space 132 is filled with fluid. For example, when the consumable 120 is disposed in the chamber 110, the consumable 120 can substantially seal the chamber 110. The valves 109a, 109b, 109c can be moved to an extended position, thereby sealing the flow paths 123, 127, and 125, respectively. When the valves 109a, 109b, 109c are extended, they can be pressed on the flow paths 123, 127, and 125, respectively, thereby sealing them. As described above, when the valves 109a, 109b, 109c are retracted, the flow paths 123, 127, and 125 are opened and freely allow fluid or gas to flow into and out of the bladder 130, respectively.
[0081] In order to draw fluid into the interior space 132 of the bladder 130, the desired flow path in the outflow flow paths 123, 127 and 125 is opened via the corresponding valves (e.g., valves 109a, 109b, 109c). The remaining flow paths can be closed. For example, valve 109a can be retracted, and valves 109b and 109c can be extended, so that flow path 123 is opened, and flow paths 127 and 125 are closed. The opening of flow path 123 can allow fluid to flow into the interior space 132 only via flow path 123 and port 122.
[0082] In some embodiments, a vacuum is applied to the chamber 110, which causes the fluid to be drawn into the bladder 130 via the port 122 and the flow path 123. For example, the pressure device 106 can create a vacuum within the chamber 110 by removing all air within the chamber 110. The creation of a vacuum within the chamber 110 can 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), thereby causing the fluid to flow from the fluid source into the interior space 132 of the bladder 130.
[0083] In some embodiments, to control the volume of fluid drawn into the interior space 132 of the bladder 130, the extrusion device 105 extends the extrusion surface 112 so that the extrusion surface 112 is positioned proximate to the bladder 130 to create an expansion restriction (e.g., Figure 3B ). The position of the extrusion surface 112 and the specific parameters of the vacuum generated by the chamber 110 can be correlated to the amount of volume expected to flow into and fill the interior space 132. In some embodiments, the dispensing platform 100 uses this correlation to adjust the position of the extrusion surface 112 and the generation of the vacuum within the chamber 110 until the desired volume is drawn into the interior space 132 of the capsule 130.
[0084] In some embodiments, in order to push or drive the fluid out of the interior space 132 of the bladder 130, the desired flow path in the outflow flow paths 123, 127 and 125 is opened via the corresponding valve (e.g., valve 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 so that flow path 127 is opened, and flow paths 123 and 125 are closed. The opening of flow path 127 can allow fluid to flow out of the interior space 132 only via flow path 127 and port 126. In some embodiments, to push or expel the fluid out of the interior space 132, the extrusion device 105 extends the extrusion surface 112 (e.g., to a fully extended position) against the bladder 130 to apply a force to the interior space 132, thereby causing the interior space 132 to retract, thereby forcing the fluid to flow out of the open flow path (e.g., flow path 127) and out of a port (e.g., port 126) that is in fluid communication with one flow path. In some embodiments, the volume of fluid expelled or removed from the interior space 132 of the bladder 130 is associated with a change in the position of the extrusion surface 112.
[0085] Figure 4A According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use. Figure 4B According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use. Figure 4C According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use. Figure 4D According to various aspects of the present disclosure Figure 1A A front view of a dispensing platform, wherein the dispensing platform is in use.
[0086] refer to Figures 4A-4D The compounding platform 100 can be configured to reconstitute a drug vial, such as the second vial 160. For example, the compounding platform 100 can allow for adjustment of the ratio of a diluent and a drug (eg, medication) within a 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 a desired routine or program for the compounding platform 100 to run to achieve a desired result. For example, the user can interact with the user interface 190 to select a route intended to reconstruct a vial. The compounding platform 100 can then undergo an automatic or semi-automatic process to reconstruct the vial.
[0088] Reconstitution of a vial (e.g., second vial 160) requires fluid to flow from one or more vials into bladder 130, and from bladder 130 into one or more vials. The reconstitution fluid may then be transferred from bladder 130 to one or more vials and / or a storage container (e.g., 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, valves 109b and 109c may be closed, while valve 109a may be open. This results in fluid being able to flow into port 122 and through flow path 123, while preventing fluid from flowing into port 126 and port 124, respectively, and through flow paths 127 and 125. A vacuum may be applied by pressure device 106 within chamber 110 so that a volume of air is drawn into interior space 132 of bladder 130. The vacuum may then be removed from chamber 110.
[0090] In some embodiments, a first vial 140 is coupled to port 122 and a second vial 160 is coupled to port 124. The first vial 140 may be a fluid source of a diluent fluid and the second vial 160 may be a fluid source of a drug, such as a lyophilized drug source. A delivery bag 180 may be disposed on a storage area 185 of the compounding station 102 and may be coupled to port 126 via a delivery tubing 170.
[0091] The compounding station 102 can be configured to perform a series of push and 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 compounding station 102 can open one or more valves (e.g., valves 109a, 109b, 109c) and rotate the 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, the interior space 132 includes a volume of air due to the vacuum created within the chamber 110, which causes air to flow into the bladder 130. The pressing surface 112 can be extended by the pressing device 105 so that the pressing surface 112 applies pressure to the partially expanded air interior space 132. Since the valve 109a is opened, the air from the interior space 132 can be driven out of the bladder 130 via the flow path 123 and into the first vial 140 through the port 122. Fluid from the first vial 140, such as a diluent fluid, can be driven from the first vial 140 into the interior space 132 through the port 122 and the flow path 123, causing the fluid to be transferred from the first vial 140 and into the bladder 130 as the air is driven out of the bladder 130 and into the first vial 140. In other words, as the valve 109a is opened, the air from the interior space 132 can be driven out of the bladder 130 and into the first vial 140. Figure 4AAs shown, air may be forced from the interior space 132 into the first vial 140 , such that fluid is forced from the first vial 140 into the interior space 132 .
[0093] refer to Figure 4B , the diluent fluid from the first vial 140 can be transferred from the first vial 140 and disposed within the interior space 132, and then transferred from the interior space 132 to the second vial 160. For example, the chamber 110 can be rotated or inverted by the rotating device 107 so that the chamber 110 is in an inverted position from the baseline position (e.g., rotated 180 degrees). Before the chamber 110 is rotated or inverted, the valve 109c can be opened, and the valves 109a and 109b can be closed, so 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 approximately 180 degrees, the diluent fluid can flow from the interior space 132 through the flow path 125 and the port 124 and into the second vial 160. The second vial 160 can contain a drug or medication. The drug or medication disposed in the second vial 160 can be configured to dissolve in a diluent fluid, such as the diluent fluid disposed in the first vial 140. In some embodiments, a vacuum is created in the chamber 110 and / or the squeezing device 105 causes the squeezing surface 112 to press against the bladder 130, and retracts from the pressed bladder 130, so that the diluent fluid in the bladder 130 flows into the second vial 160.
[0095] In some embodiments, the transfer of the diluent fluid from the interior space 132 to the second vial 160 causes air that has been transferred to the first vial 140 to transfer back into the interior space 132, such that the second vial 160 at least partially includes the diluent fluid and the interior space 132 at least partially includes air (e.g., from the first vial 140). The transfer of the diluent fluid from the interior space 132 to the second vial 160 can cause air from the second vial 160 that is displaced by the diluent fluid to transfer into the interior space 132, such that the second vial 160 at least partially contains the diluent fluid and the interior 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 interior space 132 to the second vial 160. The delivery tube 170 can 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 can have a predetermined length that allows the chamber 110 and the consumable 120 to be rotated multiple times without the delivery tube 170 being twisted and 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] refer to Figure 4C , when the chamber 110 is inverted and the diluent fluid flows into the second vial 160, the rotating device 107 can be configured to rotate or oscillate the chamber 110. For example, the rotating device 107 can 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 connected to the consumable 120 disposed in the chamber 110, the rotation or oscillation of the chamber 110 may cause shaking or mixing of the substances in the second vial 160. For example, the oscillation of the chamber 110 may cause mixing of the diluent fluid and the drug in the second vial 160, so 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 reconstitution fluid from flowing from the second vial 160 into the capsule 130 during the oscillation of the chamber 110.
[0098] With the chamber 110 at 180 degrees from the baseline position, and after the diluent fluid flows into the second vial 160, the rotation device 107 can oscillate or shake the chamber 110 from between 180 and 270 degrees to between 180 and 90 degrees. In some embodiments, the rotation device 107 oscillates the chamber 110 from anywhere between 0 and 360 degrees from the baseline position of the chamber 110, so that the drug is completely dissolved in the diluent fluid in the second vial 160 and a reconstituted fluid is produced.
[0099] Reference Figure 4D, the chamber 110 can return to the baseline position as the chamber 110 oscillates and the drug dissolves in the diluent fluid in the second vial 160. When the chamber 110 returns to the baseline position, the valve 109c can open, allowing the reconstitution 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 interior space 132 can be displaced by the reconstitution fluid and can flow into the second vial 160. In some embodiments, a vacuum is created within the chamber 110 and / or the pressing device 105 causes the pressing surface 112 to press against the bladder 130, and retracts from the pressed bladder 130, so that the reconstitution fluid in the second vial 160 flows into the bladder 130.
[0100] Figure 5 According to various aspects of the present disclosure Figure 1A A front perspective view of a dispensing platform, wherein the dispensing platform is in use.
[0101] Reference Figure 5 , the reconstitution fluid disposed within the bladder 130 can be delivered to the delivery bag 180 via the delivery tube 170. For example, when the reconstitution fluid is transferred to the interior space 132, the valve 109c can be extended to close the flow path 125 and prevent the fluid from flowing through the port 124 and the flow path 125. The valve 109b can be retracted to open the flow path 127, thereby allowing the fluid to flow from the interior space 132 through the flow path 127 and the port 126 to the delivery bag 180 connected to the port 126 via the delivery tube. In some embodiments, a vacuum is generated within the chamber 110 and / or the pressing device 105 causes the pressing surface 112 to press against the bladder 130 and retract from the pressed bladder 130, so that the reconstitution fluid within the interior space 132 flows into the delivery bag 180 via the delivery tube 170.
[0102] In some embodiments, the chamber 110 is rotated prior to transferring the reconstitution fluid to the delivery bag 180. For example, the chamber 110 can be rotated approximately 180 degrees from the baseline position and the reconstitution fluid can be transferred from the interior space 132 to the delivery bag 180. Inverting the chamber 110 prior to transferring the reconstitution 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 that couples 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 leak-free 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 hazardous materials, in order to prevent harm to individuals around the compounding platform 100, the second end 173 may include a leak-proof or leak-free drug transfer device to prevent leakage of the hazardous materials when the delivery tube 170 is separated from the delivery bag 180.
[0104] In some embodiments, the second end 173 includes a dangerous drug safety needle. For example, the second end 173 may include a rounded safety needle to protect medical personnel during the separation of the second end 173 from the delivery bag 180. In some embodiments, the rounded safety needle includes a spring and a protective rounded head disposed on the needle. The spring can be extended so that the protective rounded head covers the end of the needle. The protective rounded head can be retracted by applying a force to expose the needle. Once the force is removed, the protective rounded head can 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 can be disposable to allow the user to discard the consumable 120 when the desired task is completed (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 together 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 dangerous, the consumable 120 can be discarded together with the first vial 140, the second vial 160, and / or the delivery tube 170. In some embodiments, when the reconstitution fluid is transferred from the second vial 160 to the capsule 130, the consumable 120 can be removed from the chamber 110 and stored in a safe location for later use.
[0106] In some embodiments, the compounding platform 100 is configured to generate a reconstitution fluid for transfer to the delivery bag 180. For example, using a series of extensions and retractions of the valves 109a, 109b, 109c, with the chamber 110 in a baseline position, a diluent fluid can be transferred from the first vial 140 to the interior space 132, and a drug from the second vial 160 can be transferred from the second vial 160 to the interior space 132. In some embodiments, the diluent fluid and the drug are transferred to the interior space 132 simultaneously. While the diluent fluid and the drug are transferred to the interior space 132, the chamber 110 can be rotated and / or oscillated by the rotating device 107 to dissolve the drug in the diluent fluid, thereby generating a reconstitution fluid within the interior space 132.
[0107] In some embodiments, as the reconstitution fluid is generated, the reconstitution fluid may be transferred to the delivery bag 180 via the delivery tubing 170. Prior to transferring the reconstitution fluid to the delivery bag 180, the chamber 110 may be inverted to prevent air from being transferred to the delivery bag 180.
[0108] In some embodiments, delivery bag 180 is empty prior to transferring fluid from bladder 130 to delivery bag 180. Alternatively, delivery bag 180 may include a fluid, such as saline solution, configured to mix with the reconstitution fluid as it is transferred from bladder 130 to delivery bag 180.
[0109] The disclosure described in this article includes at least the following items:
[0110] Item 1: A compounding platform comprising: a compounding station, the compounding station comprising a user interface and a rotating device configured to receive input from a user; a chamber, the chamber is connected to the compounding station, wherein the rotating device is connected to the chamber and is configured to rotate the chamber relative to the compounding station; a consumable, the consumable is configured to be disposed in the chamber, the consumable comprising a plurality of ports and a bladder in fluid communication with the plurality of ports; a first vial, the first vial being removably connected to the consumable via a first port among the plurality of ports, the first vial comprising a diluent fluid; a second vial, the second vial being removably connected to the consumable via a second port among the plurality of ports, the second vial comprising a drug; and a plurality of valves, the plurality of valves being configured to control fluid flow into and out of the bladder, wherein the plurality of valves correspond to the plurality of ports.
[0111] Clause 2: The dispensing platform of clause 1, wherein the consumable comprises a sealing element configured to allow the bladder to communicate with the plurality of ports.
[0112] Clause 3: The dispensing platform of clause 2, wherein the chamber comprises a slot and the consumable is placed through the slot such that the sealing element engages the slot to secure the bladder within the chamber.
[0113] Clause 4: The dispensing platform of clause 3, wherein the chamber is airtight when the consumable is inserted through the slot and the sealing element is disposed within the slot.
[0114] Clause 5: The dispensing platform of Clause 2, wherein the sealing element comprises a first port and a second port.
[0115] Clause 6: The dispensing platform of clause 1, wherein the bladder comprises a first flow path in fluid communication with the first port and a second flow path in fluid communication with the second port.
[0116] Clause 7: The dispensing platform of clause 6, wherein the plurality of valves comprises 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.
[0117] Clause 8: The dispensing platform of clause 6, wherein the first flow path is in fluid communication with the first vial when the first vial is coupled to the first port.
[0118] Clause 9: The dispensing platform of clause 6, wherein the second flow path is in fluid communication with the second vial when the second vial is coupled to the second port.
[0119] Clause 10: The dispensing platform of clause 1, further comprising:
[0120] A delivery bag is removably coupled to the consumable via a third port of the plurality of ports.
[0121] Clause 11. The dispensing platform of clause 10, wherein the third port is coupled to a delivery tube that couples the delivery bag to the third port.
[0122] Clause 12: The dispensing platform of Clause 1, further comprising a pressure device coupled to the chamber, the pressure device configured to create a vacuum within the chamber.
[0123] Item 13: The preparation platform according to Item 1 also includes an extrusion device, which is connected to the chamber, and the extrusion device includes an extrusion surface arranged in the chamber, and the extrusion device has a retracted position and an extended position, wherein when the extrusion device is in the extended position, the extrusion device is closer to the bladder than when the extrusion device is in the retracted position.
[0124] Clause 14: The dispensing platform of clause 1, wherein the chamber is a vacuum chamber.
[0125] Clause 15. The dispensing platform of Clause 1, wherein the first port and the second port allow for bi-directional fluid communication.
[0126] Clause 16. The dispensing platform of Clause 1, wherein the bladder comprises an interior space in fluid communication with the first vial and the second vial.
[0127] Item 17: The preparation platform according to Item 1 further includes a controller, which is disposed in the preparation station and is communicatively connected to the user interface, and the controller is configured to cause the preparation station to perform a set of operations in response to 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 in the chamber.
[0128] Clause 18: The compounding platform of clause 1, wherein the rotation device rotates the chamber from 0 degrees to 360 degrees relative to the compounding station from a baseline position.
[0129] Item 19: A compounding platform comprising: a compounding station, the compounding station comprising a user interface and a rotating device configured to receive input from a user; a chamber, the chamber being coupled to the compounding station and having a slot, wherein the rotating device is coupled to the chamber and rotates the chamber from a baseline position from 0 degrees to 360 degrees relative to the compounding station; a consumable, the consumable being configured to be disposed in 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 comprises a slot, and the consumable is disposed through the slot so that the sealing element engages with the slot to secure the bladder in the chamber; a first vial, the first vial being removably coupled to the consumable via a first port of the plurality of ports, the first vial comprising a diluent fluid; a second vial, the second vial being removably coupled to the consumable via a second port of the plurality of ports, the second vial comprising a drug, wherein the bladder comprises a fluid in fluid communication 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; an extrusion device coupled to the chamber, the extrusion device comprising an extrusion surface disposed in the chamber, the extrusion device having a retracted position and an extended position, wherein the extrusion device is closer to the bladder in the extended position than when the extrusion device is in the retracted position; a pressure device coupled to the chamber, the pressure device configured to generate a vacuum in the chamber; and a delivery bag removably coupled to the consumable via a third port of the plurality of ports, wherein the bladder comprises a first flow path fluidly connected to the first port and a second flow path fluidly connected to the second port, and the plurality of valves comprises a first valve and a second valve, the first valve being configured to block flow in the first flow path, and the second valve being configured to block flow in the second flow path.
[0130] Item 20: A method for preparing a medical fluid, the method comprising: inserting a consumable through a narrow slot of a chamber to place the consumable in the chamber, the consumable comprising a bladder configured to expand; creating a vacuum in the chamber to allow air to flow into the consumable through a first port; removably connecting a first vial to the chamber, the first vial containing a drug fluid and being fluidly connected to a first port of the consumable when connected to the chamber to allow the drug fluid to flow from the first vial to the bladder; rotating the chamber to allow air to flow from the consumable into the first vial via the first port, thereby causing 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 connected to a delivery bag, such that a predetermined amount of drug fluid flows to the delivery bag through the second port.
[0131] Item 21: A method of reconstituting a medical fluid, the method comprising: creating a vacuum within a chamber, the chamber being coupled to a compounding station and comprising a consumable having a first port and a second port, wherein the 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 of a plurality of valves to cause air to flow from the consumable into a first vial, causing a diluent fluid to flow 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 rotating device coupling the chamber to the compounding station the chamber so that the chamber is substantially inverted 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 so that when the second valve is opened, the second vial is in fluid communication with the consumable, the second vial comprising a drug; oscillating the chamber via the rotating device so 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 reconstitution fluid; and rotating the chamber to the baseline position via the rotating device so that the reconstitution fluid flows from the second vial to the consumable via the second port.
[0132] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Multiple modifications to these aspects are very clear to those skilled in the art, and the general principles defined herein can 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 rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the disclosure.
[0134] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered to be at least equivalent.
[0135] Phrases such as "aspects" do not mean that such aspects are essential to the subject technology, or that such aspects apply to all configurations of the subject technology. The disclosure associated with an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiments" do not mean that such embodiments are essential to the subject technology, or that such embodiments apply to all configurations of the subject technology. The disclosure associated with an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "constructions" do not mean that such constructions are essential to the subject technology, or that such constructions apply to all configurations of the subject technology. The disclosure associated with a construction may apply to all configurations or one or more constructions. A construction may provide one or more examples. Phrases such constructions may refer to one or more constructions, and vice versa.
[0136] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications 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 are related and with the customary practices in the art to which they belong.
[0137] In one aspect, the term "coupled" or the like may refer to a direct coupling. In another aspect, the term "coupled" or the like may refer to an indirect coupling.
[0138] Terms such as "top", "bottom", "front", "rear", etc. used in this disclosure should be understood to refer to an arbitrary reference frame other than the common gravitational reference frame. Thus, the top surface, bottom surface, front surface, and rear surface may extend upward, downward, diagonally, or horizontally in the gravitational reference frame.
[0139] Without departing from the scope of the subject technology, various items may be arranged differently (e.g., arranged in a different order, or divided in a different manner). All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known to or will be known to those of ordinary skill in the art in the future, and are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, none of the contents disclosed herein are intended to be contributed to the public, regardless of whether such disclosure is explicitly stated in the claims. According to the provisions of the sixth paragraph of 35 U.S.C. §112, the elements of the claims will not be interpreted unless the phrase "means" is used to clearly state the element, or in the case of a method claim, the phrase "step for..." is used to state the element. In addition, for the scope of the terms "including", "having", etc. used, such terms are intended to be inclusive in a manner similar to the term "including", as explained when "including" is used as a transitional word in the claims.
[0140] The title, background technology, content of the invention, description of the drawings and abstract of the present disclosure are incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. Submitting this application is based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific implementation, it can be seen that the description provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. This disclosure method should not be interpreted as reflecting the intention that the claimed subject matter requires more features than those explicitly stated in each claim. On the contrary, as reflected in the attached claims, the subject matter of the invention lies in less than all the features of a single disclosed configuration or operation. The claims below are therefore incorporated into the detailed description, and each claim is independently a subject matter claimed separately.
[0141] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, all claims are not intended to include subject matter that does not comply with the requirements of 35 U.S.C. §101, 102, or 103, nor should they be interpreted in such a manner.
Claims
1. A preparation platform, comprising: a dispensing station comprising a user interface configured to receive input from a user and a rotating device; a chamber coupled to the compounding station, wherein the rotation device is coupled to the chamber and configured to rotate the chamber relative to the compounding station; a consumable configured to be disposed in the chamber, the consumable comprising 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 comprising a diluent fluid; a second vial removably coupled to the consumable via a second port of the plurality of ports, the second vial comprising a medication; and A plurality of valves are configured to control fluid flow into and out of the bladder, wherein the plurality of valves correspond to the plurality of ports.
2. The preparation platform according to claim 1, wherein: The consumable includes a sealing element configured to allow the bladder to communicate with the plurality of ports.
3. The preparation platform according to claim 2, 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.
4. The preparation platform according to claim 3, wherein: When the consumable is inserted through the slot and the sealing element is disposed within the slot, the chamber is airtight.
5. The preparation platform according to claim 2, wherein: The sealing element includes a first port and a second port.
6. The preparation 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 fluid communication with the second port.
7. The preparation platform according to claim 6, wherein: The plurality of valves includes a first valve configured to block flow within the first flow path and a second valve configured to block flow within the second flow path.
8. The preparation 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 preparation 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 dispensing platform according to claim 1, further comprising: A delivery bag is removably coupled to the consumable via a third port of the plurality of ports.
11. The preparation platform according to claim 10, wherein: The third port is coupled to a delivery tube that couples the delivery bag to the third port.
12. The dispensing platform according to claim 1, further comprising: A pressure device is coupled to the chamber, the pressure device being configured to create a vacuum within the chamber.
13. The dispensing platform according to claim 1, further comprising: A squeezing device is connected to the chamber, the squeezing device includes an 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 the squeezing device is in the retracted position.
14. The dispensing platform according to claim 1, wherein: The chamber is a vacuum chamber.
15. The dispensing platform according to claim 1, wherein: The first port and the second port allow for bi-directional fluid communication.
16. The dispensing platform according to claim 1, wherein: The bladder includes an interior space in fluid communication with the first vial and the second vial.
17. The dispensing platform according to claim 1, further comprising: A controller is disposed within the compounding station and is communicatively coupled to the user interface, the controller being configured to cause the compounding station to perform a set of operations in response to 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 dispensing platform according to claim 1, wherein: The rotation device rotates the chamber from 0 degrees to 360 degrees relative to the compounding station from a baseline position.
19. A dispensing platform comprising: a dispensing station comprising a user interface configured to receive input from a user and a rotating device; a chamber coupled to the compounding station and having a slot, wherein the rotation device is coupled to the chamber and rotates the chamber from 0 degrees to 360 degrees relative to the compounding station from a baseline position; a consumable configured to be disposed 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 comprises 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 comprising a diluent fluid; a second vial removably coupled to the consumable via a second port of the plurality of ports, the second vial comprising a medication, wherein the capsule comprises an interior space in fluid communication 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; an extrusion device 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 the extrusion device is 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 sac comprises a first flow path fluidly connected to the first port and a second flow path fluidly connected to the second port, and the plurality of valves comprises 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.
20. A method of preparing a medical fluid, the method comprising: inserting a consumable through a slot of the chamber to dispose the consumable in the chamber, the consumable comprising a bladder configured to expand; Creating a vacuum in the chamber to allow air to flow into the consumable through the first port; removably coupling a first vial to the chamber, the first vial containing a drug fluid and 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 into the first vial through the first port, which causes a predetermined amount of drug fluid to flow from the first vial into the consumable; as well as The first port is closed and a second port coupled to a delivery bag is opened so that a predetermined amount of drug fluid flows to the delivery bag through the second port.
21. A method of reconstituting a medical fluid, the method comprising: Creating a vacuum within a chamber coupled to the compounding station and comprising a consumable having a first port and a second port, wherein the 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 of a plurality of valves to allow air to flow from the consumable into a first vial, causing diluent fluid to flow from the first vial to the consumable through the first port, the first vial being coupled to the first port such that the first vial is in fluid communication with the consumable when the first valve is open; rotating the chamber via a rotation device coupling the chamber to the compounding station such that the chamber is substantially inverted from a baseline position; In response to rotating the chamber, opening a second valve of the plurality of valves to allow diluent fluid to flow from the consumable to a second vial, the second vial coupled to the second port such that the second vial is in fluid communication with the consumable when the second valve is open, the second vial comprising a medication; oscillating the chamber via a rotating device so 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 reconstitution fluid; and The chamber is rotated to a baseline position via a rotation device so that the reconstitution fluid flows from the second vial to the consumable via the second port.
