Intelligent flow intravenous bag servo valve flow regulation

By designing a system including sensors, actuator-actuated valves and processors, the problems of unstable drug flow rate and disordered flow order in intravenous infusion are solved, and the highly accurate delivery and stability of the flow order of the therapeutic composition is achieved.

CN120076837APending Publication Date: 2025-05-30BECTON DICKINSON & CO
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Patent Information

Application Number
CN202380073821.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-10-18
Filing Date
2023-10-17
Publication Date
2025-05-30

AI Technical Summary

Technical Problem

During intravenous infusion, clinicians need to manually adjust the relative height of the drug bag to achieve appropriate flow rate and flow sequence, and manual adjustment is difficult and time-consuming, resulting in unstable flow rate, which may lead to confusing flow sequence and causing serious medical consequences.

Method used

A system is designed, which includes a first fluid source and a second fluid source, connected to an actuator-activated valve and a processor, respectively, monitors the flow rate and amount of fluid through a sensor, and the processor controls the position of the valve core to adjust the delivery sequence and speed of the fluid.

Benefits of technology

Highly accurate delivery of the therapeutic composition is achieved, reducing the need for manual adjustment, improving the stability of flow rate and the accuracy of flow sequence, and reducing medical risks.

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Abstract

Provided herein is a system for sequential delivery of a therapeutic composition comprising a first fluid source and a second fluid source, one or more first sensors associated with each of the first fluid source and the second fluid source, an actuator-actuated valve, and a processor in communication with the one or more sensors, wherein the processor is programmed or configured to control the actuator-actuated valve to stop and / or cause delivery of the therapeutic composition from the fluid source based on data received from the one or more sensors.
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Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Application No. 17 / 968,258, filed on October 18, 2022, entitled "Smartflow Intravenous Bag ServoValve Flow Regulation", the entire content of which is incorporated herein by reference in its entirety. Technical Field

[0003] Generally, the present disclosure relates to systems for intravenous fluid delivery, and more particularly, the present disclosure relates to systems for sequential delivery of therapeutic compositions. Background Art

[0004] In the practice of intravenous (IV) infusion "Piggy - Backing", clinicians often have to spend time adjusting the relative height of each drug bag in order to achieve an appropriate flow rate and an appropriate flow sequence. Typically, this is achieved by placing / adjusting the height of the IV drug bag such that it is higher than the saline bag, so that the increased discharge pressure of the drug bag will bias the flow from that bag ahead of the flow of the saline bag. Typically, there are check valves and roller / variable pinch valves in place to further assist in biasing the flow dynamics of the system.

[0005] However, performing these adjustments manually is difficult and time - consuming. Additionally, once the system starts to flow, the discharge pressure continuously changes as the IV bag empties (which reduces the discharge pressure). Any pressure changes in the patient's body or flow obstructions in the IV line exacerbate this situation. All of these factors can affect the drug flow rate, deviating it from the nominal drug prescription parameters prescribed by the doctor. If the flow bias is not performed correctly, or if the changes that occur in the line during infusion are large enough, the flow sequence may be reversed, as the saline will flow ahead of the drug (e.g., out of sequence). In such cases, the medical consequences can be severe, especially in oncology cases. Therefore, there is a need in the art for systems that can provide highly accurate delivery of therapeutic compositions. Summary of the Invention

[0006] The present disclosure provides a system for sequentially delivering therapeutic compositions, comprising: a first fluid source and a second fluid source; one or more first sensors associated with each of the first fluid source and the second fluid source; an actuator-actuated valve comprising a valve manifold, a valve core, and an actuator, the valve manifold having a first inlet port, a second inlet port, and an outlet port, wherein the first inlet port is in fluid communication with the first fluid source, the second inlet port is in fluid communication with the second fluid source, the valve core extends within the valve manifold, and the valve manifold and the valve core define a first valve passage and a second valve passage, wherein the valve core is movable relative to the valve manifold between a first position and a second position, in the first position, the first inlet port and the outlet port are in fluid communication via the first valve passage, in the second position, the second inlet port and the outlet port are in fluid communication via the second valve passage, and the actuator is configured to displace the valve core relative to the valve manifold between the first position and the second position; and a processor in communication with the one or more sensors, wherein the processor is programmed or configured to control the actuator to displace the valve core relative to the valve manifold between the first position and the second position based on data received from the one or more sensors.

[0007] In certain configurations, the first fluid source and / or the second fluid source is an intravenous (IV) drip bag.

[0008] In certain configurations, the one or more first sensors include a first flow sensor associated with the first fluid source and a second flow sensor associated with the second fluid source.

[0009] In certain configurations, the flow sensor is a drip counter.

[0010] In certain configurations, the IV drip bag is suspended and the flow sensor is disposed below the IV drip bag.

[0011] In certain configurations, the processor is further programmed or configured to control the actuator to move from the first position to the second position when a predetermined volume of fluid has been dispensed from the first fluid source.

[0012] In certain configurations, the processor is further programmed or configured to control the actuator to move from the second position to the first position when a predetermined volume of fluid has been dispensed from the second fluid source.

[0013] In certain configurations, the actuator is a rotary actuator.

[0014] In certain configurations, the rotary actuator rotates the valve core relative to the valve manifold between the first position and the second position.

[0015] In certain configurations, a check valve is associated with the outlet port.

[0016] In some configurations, the actuator is an encoded actuator, and the system further includes a sensor configured to detect encoded data from the actuator, and wherein the processor is further programmed or configured to determine the position of the actuator based on the encoded data.

[0017] In some configurations, the system further includes a second actuator configured to shift a first fluid source and / or a second fluid source from a first position to a second position.

[0018] In some configurations, the processor is programmed or configured to control the second actuator to shift the first fluid source and / or the second fluid source from the first position to the second position based on data received from one or more sensors.

[0019] In some configurations, the first fluid source and the second fluid source are IV bags, where the IV bags are attached to a rod, and wherein the processor is programmed or configured to control the second actuator to shift the rod based on data received from one or more sensors, thereby changing the height of the first fluid source and / or the height of the second fluid source.

[0020] In some configurations, one or more second sensors are associated with the first fluid source and / or the second fluid source, and the one or more second sensors are configured to detect the amount of fluid in the first fluid source and / or the second fluid source.

[0021] Also provided herein is a computer-implemented method for delivering multiple therapeutic compositions to a patient, comprising: providing a first fluid source, a second fluid source, one or more first sensors associated with each of the first fluid source and the second fluid source, and an actuator-actuated valve, the actuator-actuated valve including a valve manifold, a valve core, and an actuator, the valve manifold having a first inlet port, a second inlet port, and an outlet port, wherein the first inlet port is in fluid communication with the first fluid source, and the second inlet port is in fluid communication with the second fluid source, the valve core extending within the valve manifold, the valve manifold and the valve core defining a first valve passage and a second valve passage, wherein the valve core is movable relative to the valve manifold between a first position and a second position, in the first position, the first inlet port and the outlet port are in fluid communication via the first valve passage, in the second position, the second inlet port and the outlet port are in fluid communication via the second valve passage, the actuator being configured to shift the valve core relative to the valve manifold between the first position and the second position, delivering a first therapeutic composition to the patient through the first inlet port and from the first fluid source; determining, using at least one processor, that a predetermined amount of the first therapeutic composition has been delivered to the patient; causing, using an actuator controlled by the at least one processor, the valve core to move from the first position to the second position; and delivering a second therapeutic composition to the patient through the second inlet port and from the second fluid source.

[0022] In some configurations, the first fluid source and / or the second fluid source is an intravenous (IV) drip bag.

[0023] In some configurations, one or more first sensors include a first flow sensor associated with the first fluid source and a second flow sensor associated with the second fluid source.

[0024] In some configurations, the flow sensor is a drip counter.

[0025] In some configurations, the IV drip bag is suspended and the flow sensor is disposed below the IV drip bag.

[0026] In some configurations, the system further includes using at least one processor to control an actuator to move from a first position to a second position when a predetermined volume of fluid has been dispensed from the first fluid source.

[0027] In some configurations, the system further includes using at least one processor to control the actuator to move from the second position to the first position when a predetermined volume of fluid has been dispensed from the second fluid source.

[0028] In some configurations, the actuator is a rotary actuator.

[0029] In some configurations, the rotary actuator rotates a valve element relative to a valve manifold between a first position and a second position.

[0030] In some configurations, the actuator is an encoded actuator.

[0031] In some configurations, the system further includes using at least one processor and a sensor configured to detect encoded data from the actuator to determine the position of the actuator based on the encoded data.

[0032] In some configurations, a second actuator is configured to displace the first fluid source and / or the second fluid source from a first position to a second position.

[0033] In some configurations, the system further includes using at least one processor and controlling the second actuator to displace the first fluid source and / or the second fluid source from the first position to the second position at least in part based on data received from one or more sensors.

[0034] In some configurations, the first fluid source and the second fluid source are IV bags, and the IV bags are attached to a rod.

[0035] In some configurations, the system further includes using at least one processor and controlling the second actuator to displace the rod at least in part based on data received from one or more sensors, thereby changing the height of the first fluid source and / or the height of the second fluid source.

[0036] The present disclosure also provides a computer-implemented method for delivering a therapeutic composition to a patient, the method comprising monitoring, using at least one processor and at least in part based on flow rate data received from a first sensor, the delivery of a first therapeutic composition to the patient; determining, using at least one processor and at least in part based on the flow rate data received from the first sensor, that a predetermined amount of the first therapeutic composition has been delivered to the patient; and in response to determining that the predetermined amount of the first therapeutic composition has been delivered to the patient, causing, using at least one processor, a valve to stop the flow of the first therapeutic composition to the patient and to begin the flow of a second therapeutic composition to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 is a schematic diagram of a system according to a non-limiting embodiment described herein;

[0038] Figures 2A to 2B is a cross-sectional view of a valve useful in a system according to a non-limiting embodiment described herein;

[0039] Figure 3 is a schematic diagram of a system according to a non-limiting embodiment described herein;

[0040] Figure 4 is a schematic diagram of a system according to a non-limiting embodiment described herein;

[0041] Figure 5 is a schematic diagram of a system according to a non-limiting embodiment described herein;

[0042] Figure 6 is a schematic diagram of a system according to a non-limiting embodiment described herein;

[0043] Figure 7 is a schematic diagram of a computing device useful in a system according to a non-limiting embodiment described herein;

[0044] Figure 8 is a flow chart of a method according to a non-limiting embodiment described herein. DETAILED DESCRIPTION

[0045] For the purposes of the following description, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and derivatives thereof shall relate to this disclosure as oriented in the drawings. However, it is to be understood that the disclosure may assume various alternative variations and step sequences, unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the drawings and described in the following specification are merely exemplary embodiments or aspects of the disclosure. Accordingly, unless otherwise indicated, the specific dimensions and other physical characteristics associated with the embodiments or aspects of the disclosure disclosed herein should not be considered limiting.

[0046] Any aspect, component, element, structure, act, step, function, instruction, etc. used herein should not be construed as critical or essential unless explicitly described as such. Additionally, as used herein, the articles "a" and "an" are intended to include one or more items and may be interchangeable with "one or more" and "at least one". Further, as used herein, the term "kit" is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be interchangeable with "one or more" and "at least one". In cases where only one item is intended, the term "one" or similar language is used. Additionally, as used herein, the terms "having", "have", "containing", etc. are intended to be open-ended terms. Further, unless otherwise explicitly stated, the phrase "based on" is intended to mean "at least partially based on".

[0047] As used herein, the terms "communicate" and "transmit" can refer to the reception, receipt, transmission, conveyance, and / or provision of information (e.g., data, signals, messages, instructions, commands, and / or other similar elements, etc.). For one unit (e.g., a device, system, component of a device or system, and / or a combination thereof, etc.) to communicate with another unit means that this one unit is capable of receiving information from and / or sending (e.g., transmitting) information to the other unit, either directly or indirectly. This can refer to a direct or indirect connection that is inherently wired and / or wireless. Additionally, two units can communicate with each other even if the information transmitted can be modified, processed, relayed, and / or routed between the first unit and the second unit. For example, even if the first unit receives information passively and does not actively send information to the second unit, the first unit can still communicate with the second unit. As another example, if at least one intermediate unit (e.g., a third unit located between the first unit and the second unit) processes the information received from the first unit and sends the processed information to the second unit, then the first unit can communicate with the second unit. In some non-limiting embodiments, a message can refer to a network packet (e.g., a data packet, etc.) that includes data.

[0048] The term "computing device" as used herein can refer to one or more electronic devices that are configured to communicate directly or indirectly with one or more networks or via one or more networks. In some non-limiting embodiments, the computing device can include a mobile device. The mobile device can include a smart phone, a portable computer, a wearable device (e.g., a watch, glasses, lenses, clothes, etc.), a personal digital assistant (PDA), and / or other similar devices. In some non-limiting embodiments, the computing device can include a server, a desktop computer, etc.

[0049] As used herein, the term "system" can refer to one or more computing devices or a combination of multiple computing devices, such as but not limited to processors, servers, client devices, software applications, and / or other similar components. Additionally, a reference to a "server" or "processor" as used herein can refer to a previously recited server and / or processor listed as performing a previous step or function, a different server and / or processor, and / or a combination of servers and / or processors. For example, as used in the specification and claims, a first server and / or a first processor listed as performing a first step or function can refer to the same or a different server and / or processor listed as performing a second step or function.

[0050] Devices, systems, and methods are provided herein for the intravenous delivery of therapeutic agents, such as drugs. The devices, systems, and methods enhance the accuracy of the sequential delivery of therapeutic agents by using a closed-loop system such that the system can ensure patency and flushing to allow for the delivery of a highly accurate amount of drug.

[0051] Turning to Figure 1 and Figures 3 to 5 , which shows a non-limiting embodiment of system 100, which can include a rod 110 for mounting the various components of system 100. These components include a flow controller 120, valves 132, sensors 142, 152, and one or more fluid sources 140, 150. The flow controller 120 can include a computing device as described herein, which can be programmed or configured to control the valves 132 via an actuator 134 to control the delivery of fluid (e.g., a therapeutic composition) through the valves 132 to a patient. The flow controller 120 can include a display 122. The display 122 can be an interactive graphical user interface (GUI), such as a touch screen, to allow a user to view the delivery status of one or more therapeutic agents from the one or more fluid sources 140, 150 and optionally allow the user to control the actuator 134.

[0052] In some non-limiting embodiments, the one or more fluid sources 140, 150 can include one or more associated sensors thereon or adjacent thereto. In some non-limiting embodiments, the flow controller 120 and / or the actuator 134 receive data from the sensors 142, 152, and based on the received data, determine whether the valves 132 should be moved to stop and / or start the delivery from the one or more fluid sources 140, 150. In some non-limiting embodiments, the actuator 134 and the flow controller 120 can be a single device, or the actuator 134 can communicate with the flow controller 120 wired or wirelessly and can include its own processor, memory, and similar components of a computing device as described herein.

[0053] In some non-limiting embodiments, sensors 142, 152 are flow sensors, as known to those skilled in the art. In some non-limiting embodiments, sensors 142, 152 are drip sensors (e.g., sensors configured to count the number of drips from fluid source(s) 140, 150). Sensors 142, 152 can communicate with flow controller 120 and / or actuator 134 either wired or wirelessly. In some non-limiting embodiments, one or more additional sensors can be included in system 100, e.g., a sensor (e.g., an optical sensor) can be included to determine the amount of fluid (e.g., a therapeutic composition) in fluid source(s) 140, 150. Like all sensors described herein, such sensors can communicate with flow controller 120 and / or actuator 134.

[0054] Fluid source(s) 140, 150 can be any useful type of container known to those skilled in the art. In some non-limiting embodiments, fluid source(s) 140, 150 are intravenous (IV) drip bags. Fluid source(s) 140, 150 can contain the same or different therapeutic compositions. In some non-limiting embodiments, the first fluid source 140 holds a first therapeutic composition, optionally saline, and the second fluid source 150 holds a second therapeutic composition, optionally a chemotherapeutic agent. System 100 can also include tubing 160 to fluidly connect fluid source(s) 140, 150 to valve 132. Tubing 160 can also include one or more line clamps 162 to allow manual stopping / starting of fluid delivery. System 100 can also include an intravenous (IV) line 170 between valve 132 and the patient, e.g., IV line 170 can connect valve 132 to an indwelling catheter.

[0055] Regarding valve 132, Figures 2A to 2B A cross-sectional view of a non-limiting embodiment of a useful valve 132 is shown. Valve 132 includes a housing (e.g., a manifold) 130, inlet ports 130a, 130b, an outlet port 130c, and fluid flow paths 131a, 131b within manifold 130. Valve 132 can be a valve as described in U.S. Provisional Patent Application No. 63 / 338,677, the content of which is incorporated herein by reference in its entirety. Valve 132 can be an actuator-actuated valve, where such valve 132 can be acted upon by an actuator (such as actuator 134 described herein) to move between an open state and a closed state.

[0056] Continuing to refer to the drawings, the inlet ports 130a, 130b can be in fluid communication with fluid sources 140, 150 respectively. The valve 132 can be a valve element, optionally a rotatable valve element, such that when the valve 132 rotates, it advances / retracts in the manifold 130 from a first position to a second position, in the first position, the first inlet port 130a ( Figure 2A ) is in fluid communication with the outlet port 130c through the fluid flow path 131a ( Figure 2A ), in the second position, the second inlet port 130b is in fluid communication with the outlet port 130c through the second fluid flow path 131b ( Figure 2B ). The outlet port 130c can include a check valve. As Figure 5 shown, the actuator 134 can include a shaft 136 that mates with a corresponding head 135 on the valve 132. The shaft 136 can be a male fitting, and the shaft head 135 can be a female fitting, alternatively the shaft 136 can be a female fitting, and the shaft head 135 can be a male fitting. The valve 132 can be held in place on the housing of the fluid controller 120 by a bracket 133, as Figure 4 and Figure 5 shown. In some non-limiting embodiments, the first fluid source 140 is in fluid communication with the first inlet port 130a or can be placed in fluid communication with the first inlet port, and the second fluid source 150 is in fluid communication with the second inlet port 130b or can be placed in fluid communication with the second inlet port.

[0057] Continuing to refer to the drawings, as noted above, the valve 132 can be a valve actuated by an actuator, and the system 100 can further include an actuator 134. The actuator 134 can be a rotary actuator and can rotate the valve 132 as the valve 132 moves between the first position and the second position, as described herein. In some non-limiting embodiments, the actuator 134 is a servo mechanism. As is known in the art, a servo mechanism involves the use of a coded actuator, where the positioning of the actuator can be read based on the coding on the device. In some non-limiting embodiments, the actuator 134 is coded, and the position of the actuator 134 is detected by a processor included in the actuator 134 and / or the flow controller 120, optionally by using a sensor for reading the coding on the actuator 134.

[0058] In some non-limiting embodiments, in addition to controlling the actuation of the valve 132, the flow controller 120 can also control the positioning of the fluid source(s) 140, 150 by a separate actuator (not shown). In some non-limiting embodiments, the system 100 includes a linear actuator that can change the height of the fluid source(s) 140, 150 individually or together based on commands received from the flow controller 120.

[0059] As described herein, the flow controller 120 and / or the actuator 134 may include a computing device (as described herein) to initiate and stop the delivery of the therapeutic composition based on data received from one or more sensors included in the system 100. Turning now to Figure 6 , in some non-limiting embodiments, such a system 1000 includes a communication network 1300 to provide connectivity between various components of the system, such as between the sensor 1200 and the flow controller 1100 (and / or the actuator). The communication network 1300 may include one or more wired and / or wireless networks. For example, the communication network 1300 may include a cellular network (e.g., a Long-Term Evolution (LTE) network, a Third Generation (3G) network, a Fourth Generation (4G) network, a Fifth Generation (5G) network, a Code Division Multiple Access (CDMA) network, etc.), a Public Land Mobile Network (PLMN), a Local Area Network (LAN), a Wide Area Network (WAN), a Metropolitan Area Network (MAN), a telephone network (e.g., a Public Switched Telephone Network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, a fiber-based network, a cloud computing network, etc., and / or a combination of some or all of these or other types of networks.

[0060] Now referring to Figure 7 , a diagram illustrating example components of a device 2000. The device 2000 may correspond to the flow controller 1100, the actuator, and / or the communication network 1300 (e.g., one or more devices of the communication network 1300). In some non-limiting embodiments or aspects, the flow controller 1100 and / or the communication network 1300 may include at least one computer device 2000 and / or at least one component of the device 2000. As Figure 7 illustrated therein, the device 2000 may include a bus 2020, a processor 2040, a memory 2060, a storage component 2080, an input component 2100, an output component 2120, and / or a communication interface 2140.

[0061] The bus 2020 may include components that permit communication among the various components of the device 2000. In some non-limiting embodiments or aspects, the processor 2040 may be implemented in hardware, software, or a combination of hardware and software. For example, the processor 2040 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform functions (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.). The memory 2060 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device that stores information and / or instructions for use by the processor 2040 (e.g., flash memory, magnetic memory, optical memory, etc.).

[0062] The storage component 2080 may store information and / or software related to the operation and use of the device 2000. For example, the storage component 2080 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid-state disk, etc.), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cassette tape, a magnetic tape, and / or another type of computer-readable medium and a corresponding drive.

[0063] The input component 2100 may include components that permit the device 2000 to receive information such as via user input (e.g., a touchscreen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, a camera, etc.). Additionally or alternatively, the input component 2100 may include sensors for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). The output component 2120 may include components that provide output information from the device 2000 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).

[0064] The communication interface 2140 may include transceiver-like components (e.g., a transceiver, separate receiver and transmitter, etc.) that enable the device 2000 to communicate with other devices such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication interface 2140 may permit the device 2000 to receive information from and / or provide information to another device. For example, the communication interface 2140 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, a cellular network interface, etc.

[0065] Device 2000 may perform one or more processes described herein. Device 2000 may perform these processes based on software instructions stored by a computer-readable medium (such as memory 2060 and / or storage component 2080) and run by processor 2040. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A non-transitory memory device includes a memory space located inside a single physical storage device or a memory space distributed across multiple physical storage devices.

[0066] The software instructions may be read into memory 2060 and / or storage component 2080 from another computer-readable medium or from another device via communication interface 2140. When run, the software instructions stored in memory 2060 and / or storage component 2080 may cause processor 2040 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with the software instructions to perform one or more processes described herein. Accordingly, the various embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.

[0067] Memory 2060 and / or storage component 2080 may include a data storage device or one or more data structures (e.g., a database, etc.). Device 2000 may be capable of retrieving information from, storing information in, or searching for information stored in the data storage device or one or more data structures in memory 2060 and / or storage component 2080. For example, the information may include encrypted data, input data, output data, transaction data, account data, or any combination thereof.

[0068] Provide Figure 7 The number and arrangement of the components shown in Figure 7 are provided as an example. In some non-limiting embodiments or aspects, device 2000 may include additional components, fewer components, different components, or components arranged differently compared to the components shown in

[0069] Reference Figure 8 , in some non-limiting embodiments, a flow controller and / or an actuator as disclosed herein may control the delivery of a first therapeutic composition by one or more processors. In some non-limiting embodiments, the first therapeutic composition is saline and is delivered for checking lumen patency ( Figure 8, 3020). In some non-limiting embodiments, about 10 mL of normal saline is delivered at a flow rate of about 100 mL / hr. In some non-limiting embodiments, the flow controller 120 and / or the actuator 134 control the valve 132 to deliver the second therapeutic composition (optionally 50 mL) at a flow rate of 100 mL / hr and receive data from one or more sensors associated with the fluid source holding the second therapeutic composition ( Figure 8 , 3040). Based at least in part on the data received from the sensors, the flow controller 120 determines whether a predetermined amount of the second therapeutic agent has been delivered to the patient and whether the delivery should continue. If the predetermined threshold or amount is not met (yes), the delivery of the second therapeutic composition continues ( Figure 8 , 3040), and the flow controller 120 and / or the actuator 134 continue to monitor and determine whether the delivery should continue ( Figure 8 , 3060). If the predetermined threshold or amount has been met (no), the delivery does not continue, and the flow controller 120 and / or the actuator 134 control the valve 132 to stop the delivery of the second therapeutic composition and optionally deliver the first therapeutic composition ( Figure 8 , 3080), optionally 50 mL of normal saline at a flow rate of 100 mL / hr, optionally for flushing components of the intravenous infusion set. In some non-limiting embodiments, as described, the flow controller 120 may control another actuator for adjusting the relative positioning of the fluid sources 140, 150. For example, the flow controller 120 may cause a relative change in the height between the first fluid source 140 and the second fluid source 150 to further assist in delivering the therapeutic composition (e.g., to overcome blockages in the fluid line). In some non-limiting embodiments, the flow controller 120 and / or the actuator 134 may use data related to the height of one or more fluid sources 140, 150 to determine the pressure within the tubing 160, within the IV line 170, and optionally within the patient's vasculature. In some non-limiting embodiments, one or more additional sensors provide data to the flow controller 120 and / or the actuator 134 to inform the determination of the start of delivery. For example, fluid level sensors associated with the fluid sources 140, 150 may transmit data to the flow controller 120 and / or the actuator 134 to provide an indication of the amount of therapeutic composition that has been delivered and / or retained in the fluid source.

[0070] Although the above-described devices, systems, and methods have been described in detail for purposes of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is for that purpose only and that the disclosure is not limited to the described embodiments or aspects. On the contrary, it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the disclosure contemplates that to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect.

Claims

1. A system for sequentially delivering therapeutic compositions, which comprises: a first fluid source and a second fluid source; one or more first sensors associated with each of the first fluid source and the second fluid source; a valve actuated by an actuator, which includes: a valve manifold including a first inlet port, a second inlet port, and an outlet port, wherein the first inlet port is in fluid communication with the first fluid source, and the second inlet port is in fluid communication with the second fluid source; a valve core extending within the valve manifold, the valve manifold and the valve core defining a first valve passage and a second valve passage, wherein the valve core is movable relative to the valve manifold between a first position and a second position, in the first position, the first inlet port and the outlet port are in fluid communication via the first valve passage, and in the second position, the second inlet port and the outlet port are in fluid communication via the second valve passage; and an actuator configured to displace the valve core relative to the valve manifold between the first position and the second position; and a processor in communication with the one or more sensors, wherein the processor is programmed or configured to control the actuator to displace the valve core relative to the valve manifold between the first position and the second position based on data received from the one or more sensors.

2. The system according to claim 1, wherein, the first fluid source and / or the second fluid source is an intravenous (IV) drip bag.

3. The system according to claim 2, wherein, the one or more first sensors include a first flow sensor associated with the first fluid source and a second flow sensor associated with the second fluid source.

4. The system according to claim 3, wherein, the flow sensor is a drip counter.

5. The system according to claim 3, wherein, the IV drip bag is suspended, and the flow sensor is disposed below the IV drip bag.

6. The system according to claim 3, wherein, the processor is further programmed or configured to control the actuator to move from the first position to the second position when a predetermined volume of fluid has been dispensed from the first fluid source.

7. The system according to claim 3, wherein, the processor is further programmed or configured to control the actuator to move from the second position to the first position when a predetermined volume of fluid has been dispensed from the second fluid source.

8. The system according to claim 1, wherein, the actuator is a rotary actuator.

9. The system according to claim 8, wherein, the rotary actuator rotates the valve core relative to the valve manifold between the first position and the second position.

10. The system according to claim 1, further comprises: a check valve associated with the outlet port.

11. The system according to claim 1, wherein, The actuator is a coded actuator, and the system further includes a sensor configured to detect coded data from the actuator, and wherein the processor is further programmed or configured to determine the position of the actuator based on the coded data.

12. The system according to claim 1, further comprising: a second actuator configured to shift the first fluid source and / or the second fluid source from a first position to a second position.

13. The system according to claim 12, wherein the processor is programmed or configured to control the second actuator to shift the first fluid source and / or the second fluid source from the first position to the second position based on data received from the one or more sensors.

14. The system according to claim 13, wherein the first fluid source and the second fluid source are IV bags, wherein the IV bags are attached to a rod, and wherein the processor is programmed or configured to control the second actuator to shift the rod based on data received from the one or more sensors, thereby changing the height of the first fluid source and / or the height of the second fluid source.

15. The system according to claim 1, further comprising: one or more second sensors associated with the first fluid source and / or the second fluid source, the one or more second sensors being configured to detect the amount of fluid in the first fluid source and / or the second fluid source.

16. A computer-implemented method for delivering multiple therapeutic compositions to a patient, which comprises: providing: a first fluid source; a second fluid source; one or more first sensors associated with each of the first fluid source and the second fluid source; and a valve actuated by an actuator, comprising: a valve manifold including a first inlet port, a second inlet port, and an outlet port, wherein the first inlet port is in fluid communication with the first fluid source, and the second inlet port is in fluid communication with the second fluid source; a valve element extending within the valve manifold, the valve manifold and the valve element defining a first valve passage and a second valve passage, wherein the valve element is movable relative to the valve manifold between a first position and a second position, in the first position, the first inlet port and the outlet port are in fluid communication via the first valve passage, in the second position, the second inlet port and the outlet port are in fluid communication via the second valve passage; and an actuator configured to shift the valve element relative to the valve manifold between the first position and the second position; delivering a first therapeutic composition to the patient through the first inlet port and from the first fluid source; determining, by at least one processor, that a predetermined amount of the first therapeutic agent has been delivered to the patient; moving the valve element from the first position to the second position by an actuator controlled by at least one processor; and delivering a second therapeutic composition to the patient through the second inlet port and from the second fluid source.

17. The method according to claim 16, wherein, the first fluid source and / or the second fluid source is an intravenous (IV) drip bag.

18. The method according to claim 17, wherein, the one or more first sensors include a first flow sensor associated with the first fluid source and a second flow sensor associated with the second fluid source.

19. The method according to claim 18, wherein, the flow sensor is a drip counter.

20. The method according to claim 18, wherein, the IV drip bag is suspended, and the flow sensor is disposed below the IV drip bag.

21. The method according to claim 18, further comprising: controlling, by at least one processor, the actuator to move from the first position to the second position when a predetermined volume of fluid has been dispensed from the first fluid source.

22. The method according to claim 18, further comprising: controlling, by at least one processor, the actuator to move from the second position to the first position when a predetermined volume of fluid has been dispensed from the second fluid source.

23. The method according to claim 16, wherein, the actuator is a rotary actuator.

24. The method according to claim 23, wherein, the rotary actuator rotates the valve element relative to the valve manifold between the first position and the second position.

25. The method according to claim 16, wherein, the actuator is a coded actuator.

26. The method according to claim 25, further comprising: determining, by at least one processor and a sensor configured to detect coded data from the actuator, the position of the actuator based on the coded data.

27. The method according to claim 16, further comprising: a second actuator configured to displace the first fluid source and / or the second fluid source from a first position to a second position.

28. The method according to claim 27, further comprising: controlling, by at least one processor and at least in part based on data received from the one or more sensors, the second actuator to displace the first fluid source and / or the second fluid source from the first position to the second position.

29. The method according to claim 28, wherein, the first fluid source and the second fluid source are IV bags, and wherein the IV bags are attached to a rod.

30. The method according to claim 29, further comprising: controlling, by at least one processor and at least in part based on data received from the one or more sensors, the second actuator to displace the rod, thereby changing the height of the first fluid source and / or the height of the second fluid source.

31. A computer-implemented method for delivering a therapeutic composition to a patient, which comprises: monitoring, by at least one processor and at least in part based on flow data received from a first sensor, the delivery of a first therapeutic composition to the patient; Determine that a predetermined amount of the first therapeutic composition has been delivered to the patient using at least one processor and at least in part based on flow data received from the first sensor; And In response to determining that a predetermined amount of the first therapeutic composition has been delivered to the patient, cause a valve to stop the flow of the first therapeutic composition to the patient and initiate the flow of a second therapeutic composition to the patient using at least one processor.