Smart Gravity IV Flow Controller

Abstract

An infusion control device capable of actively controlling and monitoring the administration of medical fluids for gravity-based infusion of medical fluids is disclosed, wherein the gravity infusion control system is connectable to an intravenous administration set and may include a flow monitor, a flow controller, and a user interface.

Description

[Technical Field]

[0001] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63 / 425,257, entitled "Smart Gravity IV Flow Controller," filed November 14, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to the administration of medical fluids, such as intravenous ("IV") medical fluid therapy, and more particularly to devices, systems and methods for controlling and monitoring gravity-based administration of medical fluids. [Background technology]

[0003] IV fluid delivery systems are used to deliver or infuse medical fluids to a patient at a controlled rate. Several such IV fluid delivery systems exist, including gravity-based systems that utilize the pressure of gravity to direct the medical fluid from an IV bag to the patient through tubing, and pump-based systems that use a mechanical pump that can engage tubing to direct the medical fluid from the IV bag to the patient.

[0004] Gravity-based infusion systems may include an IV administration set, which includes an IV bag, a drip chamber, infusion tubing, and a flow controller. The flow rate of the medical fluid to the patient is controlled by a flow controller, such as a linear actuator, roller clamp, pinch clamp, or flow valve. Typically, the patient receives the entire volume of medical fluid from the IV bag unless the flow is interrupted, such as by the patient or caregiver blocking the infusion tubing or disconnecting the infusion tubing from the patient. Pump-based infusion systems include similar components to gravity-based infusion systems, but the flow rate and amount of medication directed to the patient may be controlled using an infusion pump instead of the flow controller used in gravity-based infusion systems. Summary of the Invention [Problem to be solved by the invention]

[0005] While pump-based infusion systems may provide the ability to control and monitor the administration of medical fluids, such as by controlling the fluid flow rate and volume of medical fluid directed to a patient, pump-based infusion systems can be more complex and expensive than gravity-based infusion systems. Furthermore, gravity- and pump-based infusion systems each require a caregiver or user to assemble and configure the system, which includes ensuring that each component is prepared and properly connected together, and ensuring that infusion and fluid flow parameters are set as intended. Some systems, such as gravity-based infusion systems, may require the caregiver or user to prime the fluid pathway and maintain and / or adjust the fluid flow parameters throughout the infusion. Furthermore, some infusion systems may not provide notification in the event of a problem or error, such as an abnormal flow rate, a clogged filter, air in the fluid pathway, or unintentional disconnection of the system from the patient.

[0006] Disclosed herein, in accordance with at least some embodiments, is the recognition that while gravity-based infusion systems may offer a lower-cost alternative to pump-based infusion systems, pumps and gravity-based infusion systems require a caregiver to set, maintain, and monitor certain aspects of the administration of medical fluids. As such, the use of gravity-based infusion systems may expose patients to less potential complications and errors, which may reduce incidents that result in patient injury or inadequate care. [Means for solving the problem]

[0007] Accordingly, aspects of the present disclosure provide a gravity infusion flow control device configured to control an IV administration set, the gravity infusion flow control device comprising: a flow monitor configured to couple to the IV administration set, the flow monitor comprising a first sensor configured to detect a first flow rate of a medical fluid in a first portion of the IV administration set and a second sensor configured to detect a second flow rate of the medical fluid in a second portion of the IV administration set; and a controller configured to receive and compare the first flow rate and the second flow rate to ensure an accurate first flow rate detected by the first sensor.

[0008] Some examples of the present disclosure provide a flow controller configured to couple to a third portion of an IV administration set, the flow controller including an actuator and a movable member, the actuator configured to move the movable member between a retracted position and an extended position. In some embodiments, the movable member is configured to change a cross-sectional area of ​​an internal passage of the third portion of the IV administration set. In some embodiments, the controller is further configured to move the movable member between the retracted position and the extended position to achieve a target flow rate of medical fluid flowing through the IV administration set. In some embodiments, the movable member moves from the extended position to the retracted position when the first flow rate and the second flow rate are lower than the target flow rate. In some embodiments, the movable member moves from the retracted position to the extended position when the first flow rate and the second flow rate are higher than the target flow rate.

[0009] In some embodiments, the present disclosure provides a first sensor disposed within the IV set connector. In some embodiments, the first sensor is configured to engage with a first portion of the IV administration set so that the first sensor detects movement of medical fluid in the first portion of the IV administration set. In some embodiments, the first sensor is an optical sensor.

[0010] In some embodiments, the present disclosure provides that a second sensor is configured to engage a second portion of the IV administration set so that the second sensor detects movement of the medical fluid in the second portion of the IV administration set. In some embodiments, the second sensor is an ultrasonic sensor.

[0011] In some embodiments, the present disclosure provides that the gravity injection flow control device further comprises a user interface. In some embodiments, the user interface comprises a graphical user interface (GUI) configured to display information. In some embodiments, the controller is further configured to send an error message to the GUI if the first flow rate and the second flow rate are not equal. In some embodiments, the user interface comprises a speaker. In some embodiments, the controller is further configured to send an error tone through the speaker if the first flow rate and the second flow rate are not equal.

[0012] In some embodiments, the present disclosure provides that the first portion of the IV administration set is a medical fluid reservoir of the IV administration set. In some embodiments, the second portion of the IV administration set is a tubing of the IV administration set. In some embodiments, the second portion of the IV administration set is located downstream from the first portion of the IV administration set.

[0013] Thus, the present application addresses several operational challenges faced in prior systems and methods for administering medical fluids using gravity-based infusion systems and provides numerous improvements for controlling and monitoring the administration of medical fluids that provide patient protection from complications during infusion therapy, improve clinician and caregiver workflow, maintain patient mobility, reduce medication administration errors, increase medication safety, increase consistency in medication delivery accuracy and speed, reduce costs, increase documentation efficiency, and can prevent, detect, and resolve complications such as blockages, extravasation, and air in the fluid pathway.

[0014] Aspects of the present application may provide a gravity infusion control system that may enable control of conditions including, but not limited to, fluid flow rate, dosage, priming of an IV administration set, and automatic stopping and / or starting of infusion. Additionally, aspects of the present invention may provide monitoring of the condition of an IV administration set's fluid path, including, but not limited to, pressure, fluid flow rate, occlusion, presence of air, fluid flow rate, leaks, infiltration, and possible tampering with the IV administration set.

[0015] Additional features and advantages of the subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and embodiments herein, as well as the accompanying drawings.

[0016] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.

[0017] Various features of exemplary embodiments of the present invention are described below with reference to the drawings, which are intended to illustrate, but not limit, the present invention. The drawings include the following figures: [Brief explanation of the drawings]

[0018] [Figure 1A] 1 illustrates a gravity injection control system in use with an IV administration set, according to an embodiment of the present disclosure. [Figure 1B] 1 illustrates a gravity injection control system in use with an IV administration set, according to an embodiment of the present disclosure. [Figure 2] FIG. 1 is a detailed front view of a gravity injection control system according to aspects of the present disclosure. [Figure 3] FIG. 1 is a front view of a gravity injection control system according to aspects of the present disclosure. [Figure 4]1 is a flowchart illustrating a method for controlling a gravity injection control system according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail in order not to obscure the subject technology.

[0020] Furthermore, while the present description sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed as limiting in any way. In addition, while particular embodiments of the present disclosure may be disclosed or illustrated in the context of an IV administration set, it is contemplated that such embodiments may be used in other fluid delivery systems. Still further, various applications of and modifications to such embodiments that may occur to those skilled in the art are also encompassed by the general concepts described herein.

[0021] According to some embodiments, the present application discloses various features and advantages of a gravity infusion control system. The gravity infusion control system can provide many improvements for controlling and monitoring the administration of medical fluids. The gravity infusion control system can monitor and control the status of the administration of medical fluids using an IV administration set, and can prevent, detect, and resolve potential or actual complications associated with the administration of medical fluids.

[0022] The gravity injection control system includes a user interface, a flow monitor, and a flow controller. The user interface allows a user to set and / or adjust operating characteristics of the gravity injection control system, including, but not limited to, the dosage and / or volume of medical fluid directed to the patient, the flow rate of the medication, start and / or stop parameters for the administration of the medical fluid, and priming of the fluid pathway for the medical fluid. The user interface, in some embodiments of the present disclosure, can include a graphical user interface.

[0023] The user interface may be incorporated into the housing with either the flow detector or the flow controller, although in some embodiments the user interface may be located separately from the housing, such as on a separate remote control or handheld device. In some embodiments of the present disclosure, the user interface may be incorporated into the housing, and a separate user interface may be located separately on the remote control or handheld device.

[0024] The flow monitor enables the gravity infusion control system to couple with a medical fluid reservoir or container and detect the occurrence of flow from or through the medical fluid reservoir. The flow monitor includes an IV administration set coupler configured to engage or retain a portion of the IV administration set that forms the medical fluid reservoir, such as a drip chamber. The flow monitor also includes one or more flow sensors configured to detect either a change in mass or movement of the medical fluid reservoir to determine the occurrence of flow from or through the medical fluid reservoir. In some embodiments of the present disclosure, the one or more flow sensors may include any of a drop sensor, a weight change sensor, an ultrasonic sensor, a photovoltaic sensor, a photoelectric sensor, and / or an optical sensor.

[0025] The flow controller enables the gravity infusion control system to couple with a portion of an IV administration set that forms an internal passage for fluid flow and to control the rate of fluid flow through the internal passage. The flow controller includes a fluid control device configured to engage or retain a portion of the IV administration set that forms the internal passage, such as the IV tubing. To control the rate of fluid flow through the internal passage, the IV administration set coupler for the flow controller includes a movable member or surface that can engage with the IV tubing or with a flow control device of the IV administration set. Engagement of the movable member with the IV tubing or flow control device causes a change in the cross-sectional area of ​​the internal passage, thereby resisting flow therethrough. In some embodiments, the flow controller can be remotely controlled by a user or caregiver using a handheld or remote device.

[0026] The gravity infusion control system may be configured such that the flow monitor comprises an IV administration set connector and the flow controller comprises a movable portion that can extend and retract to engage the IV tubing, however, it should be understood that the present disclosure contemplates embodiments in which the flow monitor and flow controller comprise multiple IV administration set connectors.

[0027] 1-2, an embodiment of a gravity infusion control system 100 is illustrated in use with an IV administration set. The gravity infusion control system 100 includes a user interface, a flow monitor, and a flow controller.

[0028] Gravity infusion control system 100 is coupled to an IV administration set having an IV bag 12 and a drip chamber 14, which are fluidly coupled together by IV tubing 16 extending therebetween. Flow control device 20 is positioned proximate drip chamber 14 and configured to contact a length of IV tubing 18 extending between drip chamber 14 and a patient. IV tubing 18 may be intravenously connected to the patient through a catheter. IV administration set and gravity infusion control system 100 are disposed together with drip chamber 14, which is coupled to an IV administration set coupler 120.

[0029] The IV bag 12 may be suspended, the drip chamber 14 may be inserted into the IV administration set connector 120, and the flow control device 20 may be positioned adjacent to the drip chamber 14 along the IV tubing 18. The processor of the gravity infusion control system 100 may determine whether there is air in the internal passageways of the IV administration set, which may be displayed by the graphical user interface 114. After connecting the IV tubing 18 of the IV administration set to the patient, a combination of the buttons 112, the graphical user interface 114, and the speaker 116 of the user interface 110 may be used to initiate the infusion process. Initiating the infusion process may include entering operating parameters such as a fluid flow rate for the medical fluid and an amount of medical fluid to be administered.

[0030] Gravity injection control system 100 can also receive, transmit, and store data and / or documentation regarding any of the patient's identification information, medications or medical fluids, and injection parameters. Additionally, gravity injection control system 100 can monitor and control the injection process by preventing, detecting, and resolving complications such as blockages, spills, and air in the fluid path.

[0031] 3, the flow monitor may include an IV administration set coupler 120 (not shown) configured to engage or retain a medical fluid reservoir of an IV administration set, such as drip chamber 14. In some embodiments of the present disclosure, the flow monitor is configured to couple with one or more medical fluid reservoirs of an IV administration set.

[0032] To enable connection with drip chamber 14, housing 210 of gravity infusion control system 100 may form at least a portion of IV administration set connector 120 for the flow monitor. Housing 210 may define a slot or channel 220, which may be configured to receive drip chamber 14 and at least a portion of IV tubing 18 therein.

[0033] When coupled to an IV administration set, the flow monitor can identify the presence or absence of fluid flow from the IV administration set's medical fluid reservoir. To identify the presence or absence of fluid flow from the IV bag 12, the drip chamber 14, or another medical fluid reservoir of the IV administration set, the flow monitor includes an optical sensor 230 coupled to the IV administration set coupler 120. In some embodiments, the optical sensor 230 is disposed within the IV administration set coupler 120. The optical sensor 230 may include a sensor for detecting movement within the medical fluid reservoir. In some embodiments, the optical sensor 230 may be a photovoltaic sensor configured to detect the drop of liquid flowing through the drip chamber 14. To verify fluid flow from the drip chamber 14 or another medical fluid reservoir of the IV administration set, the flow monitor further includes an ultrasonic sensor 240 positioned along the IV tubing 18 in the channel 220 adjacent to the IV administration set coupler 120 as part of the error prevention system of the gravity infusion control system. Ultrasonic sensor 240 may include either a sensor that detects movement of medical fluid within IV tubing 18. In some embodiments, ultrasonic sensor 240 may be configured to detect changes in the rate of flow through IV tubing 18.

[0034] The flow controller of the gravity infusion control system may include a flow control device 20 configured to control the rate of fluid flow through an IV administration set. The flow control device 20 may control the rate of fluid flow through the IV administration set by engaging the IV tubing 18 of the IV administration set, where the flow control device 20 of the IV administration set may be, but is not limited to, a servo-based linear actuator, a cylindrical clamp, a roller clamp, a pinch clamp, or another device configured to vary the rate of fluid flow through the internal passage of the IV tubing 18. In some embodiments of the present disclosure, the flow control device 20 for the flow controller may cause a change in the cross-sectional area of ​​the internal passage of the IV tubing 18.

[0035] To control the rate of fluid flow through the IV administration set, the flow control device 20 includes a movable member, such as a knob 290, that engages the IV tubing 18 in an extended position. The movable member of the flow control device 20 can engage the IV tubing 18 against an opposing surface 280 of the channel 220, as illustrated in FIG. 2 . The flow control device 20 can move the knob 290. When the knob 290 of the flow control device 20 moves from a retracted position to an extended position, the IV tubing 18 extending between the knob 290 and the opposing surface 280 is compressed or squeezed, thereby changing the cross-sectional area of ​​the internal passage of the IV tubing 18.

[0036] The flow control device may include an alignment and / or retention mechanism to orient the flow control device with the IV tubing 18. The alignment and / or retention mechanism may be configured to ensure that the IV tubing 18 is engaged by the knob 290 of the flow control device 20 when moving from the retracted position to the extended position. Additionally, the alignment and / or retention mechanism may hold the flow control device in its intended position within the flow control device.

[0037] In some embodiments of the present disclosure, knob 290 directly engages IV tubing 18, such that the length of IV tubing 18 is compressed, resisting fluid flow therethrough, as illustrated in the gravity infusion control system of Figures 1-2. Conversely, movement of knob 290 from an extended position to a retracted position can cause IV tubing 18 to expand to a released position, thereby decreasing resistance to fluid flow therethrough.

[0038] Upon completion of the infusion process, the flow controller can cause the flow control device 20 to block the internal passageway of the IV administration set, such as by completely closing off the cross-sectional area of ​​the IV tubing 18. In some embodiments of the present disclosure, the flow controller can restrict the internal passageway of the IV administration set to block fluid flow therethrough upon identification of a complication, such as a leak.

[0039] An IV administration set can be connected to the gravity infusion control system 100 by positioning the drip chamber 14 or other medical fluid reservoir in the channel of the flow monitor and inserting the IV tubing 18 through the passage of the flow controller. To control the rate of fluid flow through the IV tubing 18, a movable member can cause the length of the IV tubing 18 to compress and resist fluid flow therethrough.

[0040] The gravity injection control system's user interface 110 is configured to allow a user to set and / or adjust operating characteristics of the system and the injection process. The user interface 110 may include one or more buttons 112 or other devices, such as dials, switches, knobs, etc., for interacting with, controlling, and monitoring the gravity injection control system. The buttons 112 may allow a user to set at least a target flow rate or a target delivery volume.

[0041] In some embodiments of the present disclosure, gravity injection control system 100 may include a graphical user interface (GUI) 114. Graphical user interface 114 may display data and information regarding system and operating characteristics of the injection process. In some embodiments, graphical user interface 114 may be configured as a touchscreen display, which may allow a user to interact with the gravity injection control system by touching areas on the touchscreen display. In some embodiments of the present disclosure, gravity injection control system 100 may include a speaker 116. Speaker 116 may be configured to emit a tone or sound, or a combination of tones or sounds, that can be heard by a user or caregiver.

[0042] The controller 250 of the gravity injection control system may provide functionality for receiving various signal inputs from sensors and transmitting signal outputs necessary for using a gravity injection control system according to various aspects of the subject technology. The controller 250 according to exemplary embodiments of the present disclosure may include a processor (e.g., a computer, microprocessor, CPU, application-specific integrated circuit (“ASIC”), circuitry, logic circuitry, etc.). The memory may be embodied, for example, by a non-transitory memory that stores software instructions, playback algorithms, etc., that, when executed, transmit and receive information, and the processor may be configured to execute programs, software instructions, playback algorithms, etc. As used herein, the memory and processor may be embodied as separate semiconductor circuits. Alternatively, the memory and processor may be embodied as a single integrated semiconductor circuit. The processor may also incorporate one or more processors. The associated non-transitory memory stores software instructions that, when executed by the processor of the controller 250, provide functionality for transmitting and receiving information necessary to control fluid flow within an IV administration set and identify anomalies in the operation of the gravity injection control system.

[0043] The system may identify an abnormality by comparing signals 410 and 420. Signals 410 and 420 (both measuring the flow rate of fluid through IV tubing 16, 18) are expected to match under normal conditions. If signals 410 and 420 match, it may be determined that there is no abnormality (at least initially). If signals 410 and 420 do not match, it may be determined that there is an abnormality. For example, signal 410 may be from optical sensor 230 in drip chamber 14, and signal 420 may be from ultrasonic sensor 240 in IV tubing 18. If the signal from optical sensor 230 does not match the signal from ultrasonic sensor 240, the system may detect an abnormality. Alternatively, if one or more of signals 410 and 420 are unavailable, the system may determine a system fault, provide an alert, and / or perform diagnostic procedures to determine whether the signal fault can be identified and corrected.

[0044] If signals 410 and 420 correspond but do not equal the target flow rate input by the user or caregiver at user interface 110, controller 250 can implement flow control to decrease or increase the flow rate of the fluid in IV tubing 18. If signals 410 and 420 indicate that the fluid flow rate measured in IV tubing 18 is higher than the target flow rate, controller 250 can move knob 290 of flow control device 20 from a retracted position to an extended position, thereby reducing the cross-sectional area of ​​the internal passageway of IV tubing 18. However, to achieve the target flow rate, controller 250 can stop knob 290 partially between the retracted and extended positions. If signals 410 and 420 indicate that the fluid flow rate measured in IV tubing 18 is lower than the target flow rate, controller 250 can move knob 290 of flow control device 20 from the extended position to the retracted position, thereby increasing the cross-sectional area of ​​the internal passageway of IV tubing 18. However, to achieve a target flow rate, the controller may stop the knob 290 partially between the extended and retracted positions.

[0045] FIG. 4 illustrates an example flow diagram for the fault prevention function of controller 250 of a gravity injection control system in accordance with various aspects of the subject technology. According to various implementations, controller 250 receives signal 410 indicative of input from ultrasonic sensor 240 and signal 420 indicative of input from optical sensor 230. If signals 410 and 420 are equal, controller 250 continues operation of the gravity injection control system. If signals 410 and 420 are not equal, indicating an abnormality, controller issues an error to graphical user interface 114. The error may be an error message displayed on graphical user interface 114 and / or an error tone transmitted through speaker 116. Upon detecting an abnormality, controller 250 ignores input from optical sensor 230 and prioritizes input from ultrasonic sensor 240. Controller 250 periodically compares signals 410 and 420 to determine the continued presence of an abnormality. This periodic comparison period may be, for example, every 15 seconds. If controller 250 determines that the values ​​of signals 410 and 420 are equal, the error is terminated.

[0046] Controller 250 also couples gravity injection control system 100 to a network (not shown) through a network interface. The network interface may include, for example, a wireless access point (e.g., Bluetooth or WiFi) or wireless communication circuitry for connecting to a wireless access point. The network interface may also include hardware (e.g., Ethernet hardware) for connecting the gravity injection control system to one of multiple networks, such as a local area network (LAN), a wide area network (WAN), a wireless LAN, or part of a computer network, such as an intranet, or the Internet. Any or all components of controller 250 may be used in connection with the subject disclosure. Such coupling of the gravity injection control system to a network may enable remote monitoring and control of the gravity injection control system by a user or caregiver.

[0047] The gravity injection control system of the present disclosure may further provide features directed to detecting potential or actual complications associated with the injection process. In some embodiments, the gravity injection control system may provide a system or subsystem configured to identify potential complications associated with the fluid pathway, including, but not limited to, blockages, air in the fluid pathway, fluid pathway leaks or spills, and instabilities in the flow of medical fluid. To detect potential or actual complications, the gravity injection control system may include sensors, such as air-in-line sensors, weight sensors, and / or pressure sensors.

[0048] In some embodiments of the present disclosure, the gravity injection control system is configured to be interlockable with one or more subsystems or modules, such as an air-in-line subsystem, an anti-tamper subsystem, an infiltration subsystem, a leak detection subsystem, a pressurization subsystem, and / or a patient data subsystem.

[0049] The gravity injection control system may provide a workflow with improved efficiency and reliability compared to other injection systems. The workflow associated with the gravity injection control system may include, but is not limited to, a preparation phase, a priming phase, an injection phase, an injection maintenance phase, and an injection termination phase. It should be understood that one or more phases may occur simultaneously or sequentially.

[0050] During the preparation phase of the workflow, a caregiver can scan a patient's wristband for patient identification and verification. During the priming phase, a caregiver can install an IV administration set into the gravity infusion control system and begin priming the fluid pathway. The priming phase may also include an indication by the gravity infusion control system that there are no complications, such as air in the fluid pathway. During the infusion phase, a caregiver can input a target fluid drop rate and begin or start the infusion process. The infusion phase or any other phase may initiate the saving of materials or data associated with the infusion process. During the infusion maintenance phase, the gravity infusion control system can provide one or more notifications, such as the occurrence of a blockage, air in the line, a malfunction, a leak, and / or a seepage. Additionally, during the infusion maintenance phase, the gravity infusion control system can automatically maintain the rate of fluid flow. During the infusion termination phase, the gravity infusion control system can automatically clamp or shut off the IV tubing fluid pathway, thereby preventing further delivery of medical fluid or unintentional leakage of medical fluid during disconnection of the IV administration set from the patient.

[0051] In some embodiments, any of the clauses herein may depend on any one of the independent clauses or any one of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) may be combined with one or more other clauses (e.g., dependent or independent clauses). In one aspect, a claim may include some or all of the words (e.g., steps, actions, means, or components) recited in a clause, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the words in each clause, sentence, phrase, or paragraph may be removed. In one aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject technology may be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject technology may be implemented using additional components, elements, functions, or operations.

[0052] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0053] Reference to a singular element is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, if present, are used for convenience only and do not limit the invention.

[0054] 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, various alternative configurations and operations described herein may be considered at least equivalent.

[0055] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as "configuration" may refer to one or more configurations, and vice versa.

[0056] In one aspect, unless otherwise stated, all measurements, values, estimates, locations, dimensions, sizes, and other specifications set forth in this specification, including the following claims, are approximate and not precise, and are intended to have a reasonable range consistent with the function to which they relate and that is customary in the art to which they pertain.

[0057] In one aspect, the term "coupled" or the like can refer to being directly coupled. In another aspect, the term "coupled" or the like can refer to being indirectly coupled.

[0058] As used in this disclosure, terms such as "upper," "lower," "front," "rear," etc. should be understood to refer to any frame of reference, rather than the typical gravity-based frame of reference. Thus, upper, lower, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in a gravity-based frame of reference.

[0059] Various items may be arranged differently (e.g., placed in a different order or divided in a different manner) without departing from the scope of the subject technology. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, paragraph 6, unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Still further, with respect to the use of the terms "comprises," "having," and the like, such terms are intended to be inclusive in the same manner as "comprises," as the term "comprises" is interpreted when used as a transitional phrase in a claim.

[0060] The Title, Background, Summary, Brief Description of the Drawings, and Abstract of this Disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as limiting descriptions. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, it may be recognized that the description provides illustrative examples, and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0061] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims as language and encompass all legal equivalents. Nevertheless, no claim is intended to, nor should it be construed to, encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A gravity infusion flow control device configured to control an IV administration set, comprising: a first sensor configured to detect a first flow rate of medical fluid within a first portion of the IV administration set; and a second sensor configured to detect a second flow rate of the medical fluid within a second portion of the IV administration set; a flow monitor configured to couple to the IV administration set, comprising: a controller configured to receive and compare the first flow rate and the second flow rate to ensure an accurate first flow rate is detected by the first sensor; A gravity injection flow rate control device comprising:

2. The gravity infusion flow control device of claim 1 , further comprising a flow controller configured to couple to a third portion of the IV administration set.

3. the flow controller comprising an actuator and a movable member; The gravity injection flow control device of claim 2 , wherein the actuator is configured to move the movable member between a retracted position and an extended position.

4. The gravity infusion flow control device of claim 3 , wherein the movable member is configured to vary a cross-sectional area of ​​an interior passageway of the third portion of the IV administration set.

5. 5. The gravity infusion flow control device of claim 4, wherein the controller is further configured to move the movable member between the retracted and extended positions to achieve a target flow rate of the medical fluid through the IV administration set.

6. 6. The gravity injection flow control device of claim 5, wherein the movable member moves from the extended position toward the retracted position when the first flow rate and the second flow rate are less than the target flow rate.

7. 6. The gravity injection flow control device of claim 5, wherein the movable member moves from the retracted position toward the extended position when the first flow rate and the second flow rate are higher than the target flow rate.

8. The gravity injection flow control device of claim 1 , wherein the first sensor is located in an IV set connector.

9. 9. The gravity infusion flow control device of claim 8, wherein the first sensor is configured to engage the first portion of the IV administration set such that the first sensor detects movement of the medical fluid in the first portion of the IV administration set.

10. 10. The gravity injection flow control device of claim 9, wherein the first sensor is an optical sensor.

11. 10. The gravity infusion flow control device of claim 1, wherein the second sensor is configured to engage the second portion of the IV administration set such that the second sensor detects movement of the medical fluid in the second portion of the IV administration set.

12. The gravity injection flow control device of claim 11 , wherein the second sensor is an ultrasonic sensor.

13. The gravity injection flow control device of claim 1 , wherein the gravity injection flow control device further comprises a user interface.

14. 14. The gravity injection flow control device of claim 13, wherein the user interface comprises a graphical user interface (GUI) configured to display information.

15. 15. The gravity injection flow control device of claim 14, wherein the controller is further configured to send an error message to the GUI if the first flow rate and the second flow rate are not equal.

16. The gravity injection flow control device of claim 13 , wherein the user interface comprises a speaker.

17. 17. The gravity injection flow control device of claim 16, wherein the controller is further configured to transmit an error tone through the speaker if the first flow rate and the second flow rate are not equal.

18. 10. The gravity infusion flow control device of claim 1, wherein the first portion of the IV administration set is a medical fluid reservoir of the IV administration set.

19. 20. The gravity infusion flow control device of claim 18, wherein the second portion of the IV administration set is a tubing of the IV administration set.

20. 10. The gravity infusion flow control device of claim 1, wherein the second portion of the IV administration set is located downstream from the first portion of the IV administration set.

21. 1. A gravity infusion flow control device configured to control an IV administration set, comprising: a first sensor configured to detect a first flow rate of medical fluid within a first portion of the IV administration set; and a second sensor configured to detect a second flow rate of the medical fluid within a second portion of the IV administration set; a flow monitor configured to couple to the IV administration set, comprising: a flow controller comprising a movable member configured to move between a retracted position and an extended position to couple to a third portion of the IV administration set; receiving and comparing the first flow rate and the second flow rate to ensure an accurate first flow rate detected by the first sensor; Moving the movable member between the retracted position and the extended position varies the cross-sectional area of ​​the interior passageway of the third portion of the IV administration set to achieve a target flow rate of the medical fluid through the IV administration set. Controller configured to A gravity injection flow rate control device comprising:

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