DESC:FIELD OF THE INVENTION
The present invention relates to a machine learning (ML) model enabled bio-medical system for controlling and monitoring of intravenous (IV) fluid from an IV bag into a patient body wirelessly. The invention proposes a novel fluid control mechanism, which is portable, economical and automatically regulates the rate of fluid flow.
BACKGROUND OF THE INVENTION
Infusion of fluids, such as medications, nutrients, or blood products, through intravenous access in a controlled manner, is a common treatment protocol in modern medicine. The rate of fluid infusion is a critical parameter that determines the efficiency of this treatment. Measurement-based robust monitoring and control are necessary to ensure the effectiveness of IV therapy, failure of which can lead to various medical complications like fluid imbalance, air embolism extravasations, etc.
Infusion pumps are used to eliminate the need for manual administration and thus reduce the risk of human error in intravenous infusion. But Infusion pumps available in the market are too costly and are not simple to use and they don't help in remote monitoring of infusions. The lack of effective flow-regulating systems forces the nurses to either leave the rate-setting process behind or tediously spend time on it. Even though the nurse spends time setting the flow rate accurately as prescribed, the rate varies over the course due to various factors like patient blood pressure, Creep of the tube, movement etc. These errors go unnoticed until the occurrence of an adverse event.
A novel fluid control mechanism is proposed, which is portable, economical and automatically regulates the rate of fluid flow.
OBJECTS OF THE INVENTION
To develop a novel fluid control and monitoring mechanism to enable nurses to set up IV infusions accurately, ensuring that the fluid flow rates are set precisely as prescribed.
To develop a sensing mechanism with IR-based drop counting and machine learning algorithms, for enhanced accuracy and predictive capabilities in monitoring and controlling IV fluid flow.
To offer a significant improvement over existing large volume infusion pumps by providing a more user-friendly, cost-effective, and reliable solution with a custom made IV set and modulated flow controlling actuators.
To develop an infusion therapy administration system with remote control and monitoring capabilities.
SUMMARY OF THE INVENTION
A novel infusion controlling device that will help the nurse set up infusions accurately and monitor it continuously. The alert messages the device sends to the nursing station can be especially valuable in cases of critical rate variations, blockages, or completion of the drip. This can help nurses respond quickly to any issues that arise, potentially preventing adverse events or complications.
The system is comprised of a specially designed IV set, an electronic actuator, a drop counter and monitoring and data managing software.
Drop counter: The IR-based drop counter measures the rate of fluid flow through the drip chamber by counting the time between two consecutive drops. The sensor works along with a machine learning algorithm so that it can be used to predict the discrepancy in the drop factor labelled in the IV set and distinguish between full flow and no flow
IV set: The intravenous set is a disposable tubing system through which the fluid is channelled from the source (e.g., a saline bag) to the patient. It includes a drip chamber, tubing, a flow regulating module and an infusion needle or catheter. The IV set is designed to function with the novel infusion monitoring system. Its drip chamber is positioned in such a way that it can be easily clamped onto the drop sensor. Unlike normal IV sets, the new IV set also has a valve where the electronic actuator can be plugged in to control the fluid delivery.
Electronic Actuator: This unit consists of an electronic actuator that regulates the fluid flow through the IV set. The modulated flow control can dynamically adjust the flow rate based on specific parameters.
Nursing station monitoring module: This module is likely installed at the nursing station and serves as the interface for healthcare professionals to monitor and manage the fluid delivery system. It may display real-time data on flow rates, provide alerts for any anomalies or issues, and potentially allow for remote adjustments to the system.
In an aspect, unlike conventional infusion pumps that rely on peristaltic movement or mechanical clamping, this invention utilizes a flow-regulating actuator that dynamically switches between predefined flow modes in a custom IV set. The actuator, controlled by a motor, alternates between a fully closed state, a fully open state, and intermediate pre-configured flow rates to achieve the desired infusion rate. Instead of exerting continuous force on the tubing, the actuator modulates flow in pulses, thereby achieving the same net infusion rate while reducing power consumption and mechanical wear.
In an aspect, to enhance drop sensing accuracy, the invention employs a machine learning algorithm that processes IR sensor data to distinguish between no-flow and continuous-flow states, a capability lacking in conventional drop sensors. This prevents errors where continuous flow is misinterpreted as no-flow, significantly improving monitoring reliability and patient safety.
In an aspect, to address errors arising from variations in IV set drop factors, the system integrates control logic unit calibration for precise volume calculation. By continuously analysing the difference between actual infusion duration and expected duration based on flow rate and drop factor, the software recalibrates the IV set's effective drop factor. This automated process eliminates discrepancies caused by the ±10% variation in drop factors found in standard IV sets, ensuring more accurate fluid administration.
Additionally, the system features wireless connectivity, enabling remote monitoring and real-time alerts for nurses and healthcare professionals. This ensures timely intervention in case of anomalies, further reducing the risk of adverse events. The invention provides a cost-effective, and highly accurate alternative to existing infusion pumps and gravity-based controllers, offering automated, real-time regulation of IV fluid flow without requiring frequent recalibration or expensive mechanical precision.

DESCRIPTION OF THE DRAWINGS
Other objects and advantages of the present invention will become apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments, in conjunction with the accompanying drawings, wherein like reference numerals have been used to designate like elements, and wherein:
Figure 1 illustrates a front of the proposed system (1) with modulated infusion control device (100) along with the IV bag and custom IV set (105), in accordance with a non-limiting exemplary embodiment of the present disclosure.
Figure 2A to 2C illustrates sensor along with the different modes of flow that can be detected.
Figure 3A and 3B illustrates a silicone tube-based valving system with a cam actuator that can be used along with the infusion controller.
Figure 4A to 4C illustrates linear slide-based valving system that can be used with infusion controller showing different states of operation.
Figure 5A illustrates a disc-based valving system that can be used with infusion controller.
Figure 5B-5C illustrates different states of disc-based valving system from fully open to close positions.
Figure 6 illustrates the isometric view of the system (1).

DETAILED DESCRIPION OF THE INVENTION WITH REFERENCE TO THE ACCOMPANYING DRAWINGS
In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to one skilled in the art that embodiments of the present disclosure may be practiced without some of these specific details.
Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention.
The terms and words used in the following description and claims are not limited to the bibliographical meanings but are merely used to enable a clear and consistent understanding of the invention. As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
The present invention relates to a machine learning (ML) model enabled bio-medical system (1) for controlling and monitoring of intravenous (IV) fluid from an IV bag (104) into a patient body wirelessly, The novel technical features that are associated with the present invention are as follows:
Drop Sensing: The monitoring system has an infrared (IR)-based sensing module, which can measure the drop rate by measuring the time between two consecutive drops. The following features characterise the enhanced drop sensing mechanism.
Difference between no flow and continuous flow: Usually, the IR-based drop counting instruments understand the continuous flow of fluid through the drip chamber as no-flow since there are no distinct drops identifiable by the IR sensor. Novel controller sensor can distinguish between a continuous flow and no flow with the help of an ML algorithm that works in conjunction with the IR sensor.
Calibration of IV sets’ drop factor: There is an allowed variation of (+/-) 10% from the labelled drop factor in standard IV sets available in the market. The variation in drop factor amounts to a difference between the measured flow rate and the actual flow rate. Novel Controller has a calibration feature, which helps to identify the error in the drop factor and adjust the flow measurement accordingly.
The calibration feature is automated in such a way that, following each infusion, the device might suggest a variation between the actual and labelled drop factors of the IV set and prompt the user to perform a re-calibration.
Custom-made disposable IV sets: The IV sets used in the novel infusion monitoring system, are custom-made to include the following features.
Clamping mechanism attached drip chamber: The drip chamber of the IV set has an easy clamping mechanism in its housing to make it easily latched onto the sensing unit of the machine. The mechanism ensures that the drip chamber is aligned perpendicular to the line of vision of the IR sensor to ensure optimal sensing. The horizontal tilting of the drip chamber can affect the drop size, the accurate clamping helps to maintain a constant drop factor.
Control Valve in IV set: There is a control valve in the IV set which can be attached to the actuator part of the machine. The control valve could be a
i. Silicon rubber tube segment, having two states open and closed with a specific internal diameter allowing only intermitted flow of fluid (drop by drop) in open state.
ii. A rectangular value with controllable combination of flow channels allowing multiple flow states from 0dpm, 100dpm, 250dpm etc.
iii. A rotary value with controllable combination of flow channels allowing multiple flow states from 0dpm, 100dpm, 250dpm etc.
Actuator: The actuator controls the modular flow regulator to control the fluid flow through the IV set.
The actuator switches between the predefined flow states of the IV set to maintain a certain level of fluid flow rate.
The actuator works based on the real-time flow rate received from the sensor unit. The actuator works in conjunction with an control logic unit that determines the actuation time based on real-time flow rate and remaining time.
A cam shaft-based system that can identify each position of the actuation through feedback from magnetic, light or resistance-based sensors, So as to open of close the IV tube valve.
Wireless Connectivity: The wireless connectivity unit enables communication between the system and a nursing station monitoring software.
This connectivity allows for remote monitoring and management of the fluid delivery system, enhancing efficiency and enabling timely interventions if needed
According to different non limiting exemplary embodiments of the present disclosure, an IR led based drop detection system that can be calibrated for drop size errors and detection of no-flow, continuous flow are disclosed.
The drop factor of intravenous (IV) sets refers to the number of drops required to deliver one millilitre (ml) of fluid. While manufacturers specify a nominal drop factor, this value may vary among different IV sets due to tolerances and inconsistencies arising from production processes. Consequently, reliance solely on the nominal drop factor can introduce errors in flow rate calculation. To address this issue, the embedded software within the device provides a calibration feature that enables users to compensate for such variations. The user can input an observed error value, based on empirical measurements, into the software. The system then adjusts the effective drop factor, accordingly, ensuring that the actual drop factor more accurately reflects the characteristics of the specific IV set in use. This calibration capability improves flow rate accuracy and enhances the reliability of fluid delivery monitoring.
Figure 1 illustrates the modulated infusion control device 100 setup configuring with IV bag 104 and the custom IV set 105. The IV fluid in the bag 104 is channelled to the patient’s body via IV tube at a specific flow rate. The device 100 consists of an actuator 107 which can control a valve 111 by counting the drops falling in a drip chamber 112 attached to the IV bag, where the fluid falls after coming out of the bag 104. The device 100 uses IR led photodiode pair (109, 110) as sensors to count the drops. The device has a rotary dial switch 102 for inputting the desired flow rate, volume etc. The status of the flow, volume infused selected flow rate etc are displayed on a screen 101. The device 100 also sends data back to the nursing station via wireless network so that the status of all infusions can be shown on nursing station display 106.
Figure 2 illustrates the sensor arrangement of the device 100. The device 100 comprises an infrared (IR) light-emitting diode (LED) (109) and a photodiode (110) positioned on opposite sides of the fluid path such that liquid drops fall through the optical axis between the emitter (IR) light-emitting diode 109 and the detector photodiode (110). When a drop (108a) passes between the IR LED (109) and the photodiode (110), it causes a reduction in the received light intensity on photodiode (110). This variation in light is converted into an electrical signal by the photodiode (110). Photodiode is a transducer that converts light energy to electrical energy, like a microphone which translated sound to electrical signals The electrical signal corresponding to each drop is processed by an embedded printed circuit board with microcontroller (M) in the device (100) to determine the presence and characteristics of fluid flow. Specific signal patterns corresponding to conditions such as "continuous flow" 108b and "no flow" 108c are mapped and stored within the microcontroller (M). Based on these patterns, the microcontroller M interprets real-time sensor data to detect flow status.
To enhance the accuracy of flow detection and minimize false detections, a machine learning model named random forest, trained on representative sensor signal patterns is integrated into the microcontroller M. The machine learning model is trained on data with no-flow and full-flow conditions (108b, 108c) on various IV tubes and lighting conditions. This enables more reliable discrimination between full flow 108b and no-flow 108c conditions, thereby improving the accuracy of flow rate error detection.
The device 100 operates in conjunction with a custom-designed intravenous (IV) set 105 comprising a drip chamber 112, IV tubing 114, and a control valve 111. The control valve is configured to regulate fluid flow within a predefined range, expressed in drops per minute (dpm), when in the fully open position. The operational range typically varies between approximately 0 to 400 drops per minute, depending on patient-specific factors such as clinical condition and cannula size. The resulting flow is characteristically intermittent rather than continuous, enabling accurate detection and analysis of flow patterns by the optical sensor system as previously described.
Fluid flow through the IV chamber 112 can be restricted to discrete, pre-calibrated flow rates—such as 0 dpm, 10 dpm, 50 dpm, or 250 dpm—using one or more integrated flow-regulating valves (Figure 3,4,5). Additionally, the IV set may include one or more manual flow rate limiting mechanisms, located along the IV tubing, each configured to restrict the maximum fluid flow rate to a defined threshold. For example, it can be a silicone tube with internal diameter of 1mm and length 10mm which gives a maximum flow rate of 300dpm in gravity.
As illustrated in Figure 3, in one embodiment, the control valve 111 is formed from a silicone material or a functionally equivalent elastomer that exhibits low hysteresis and requires minimal actuation force for deformation. The tubing 114 internal diameter can vary between 0.7mm to 1.4mm based on the maximum flow rate requirements. The valve 111 is actuated by a cam-shaped actuator 107 interfacing with the silicone material in the valve to achieve controlled constriction. The valve 111 is positioned and secured within the fluid pathway by a hinged or rotating door 128 integrated into the housing of device 100. Due to the elastic nature of silicone rubber, which deforms efficiently under low mechanical pressure, reliable constriction is achieved by the lateral pinching head of the valve (111) of a mechanical constrictor. This configuration ensures repeatable flow control while minimizing mechanical stress on the IV tubing.
Another embodiment utilizes a Rectangular Valve as illustrated in Figure 4, wherein the control valve (130) is rectangular in shape and comprising a pair of adjacent first and second chambers (116, 117) separated by an array of gates or openings (118) of different widths (W1, W2), wherein the first chamber (116) proximal to the drip chamber (112) being connected via an inlet port (119) to the chamber (112), wherein the second chamber (117) distal to the drip chamber (112) being configured with an outlet 120 for fluid discharge therefrom, wherein the first chamber (116) being configured with a rectangular sliding block (115) aligned parallel to the gate array (118).
Yet another embodiment, a Rotary Valve 129 (Figure 5) is employed. The control valve (129) is a rotary modulation valve and comprising a circular housing with a pair of principal ports, an ingress orifice (122) for fluid entry and an egress port (121) for fluid discharge. A plurality of gates or flow channels (122) of varying widths is positioned at the inlet end proximal to the drip chamber (112), wherein an angular closure element (123) being concentrically aligned within the valve chamber and rotatably mounted about the valve’s (129) central axis. The rotational displacement of the closure element (123) modulates fluid flow by selectively revealing or occluding individual gate openings (122) in the positions (124a, 124b, 124c).
The flow regulation system may employ intermittent modulation to achieve target average flow rates. For example, to deliver an effective infusion rate of 100 drops per minute, the algorithm may alternate the valve state between fully closed (0 drops/minute) and fully open (250 drops per minute) at timed intervals. This method approximates the desired average flow rate while reducing mechanical wear and optimizing energy efficiency.
The actuator assembly Figure 6 in the device 100, integrated with a motor 125, is mounted on the IV stand 126 and operatively controls the valves. The actuator 107 may alternately compress and release a segment of silicone tubing valve 127 111 to restrict flow without continuous force application. Additionally, in certain configurations, the actuator 107 modulates fluid flow by either rotating the closure disc 123 in the rotary valve 129 (Figure 5) or translating the block 115 in the rectangular valve 130 (Figure 4), thereby shifting between pre-calibrated flow rate settings.
The control logic unit to control the flow regulation by the actuator (107) to: (i) alternately compress and release a segment of silicone tubing valve (111) to restrict flow without continuous force application, or (ii) modulate fluid flow by rotating the closure disc (123) by driving a motor (125) to dynamically adjust the gate (122) access at predetermined intervals to maintain the desired flow profile in the rotary valve (129) or (iii) translate the block (115) horizontally across the gates (118) and vertically along the array (118) to selectively expose or block specific channels or gates (118) in the rectangular valve (130), thereby shifting between pre-calibrated flow rate settings.
The system's control logic differs fundamentally from traditional peristaltic pumps or flow control systems that rely on finely tuned mechanical pinching to maintain a constant flow. Rather than continuously deforming the IV tubing or employing rotating rollers, the present invention utilizes discrete flow modulation, involving intermittent valve actuation or periodic tube constriction, to deliver fluid at the prescribed rate.
The control logic unit evaluates real-time flow as a function of drop count and elapsed time to calculate actual flow rate. Applying a strategy similar to pulse width modulation (PWM), the algorithm transforms a continuous target flow into a pulsatile delivery pattern. By varying the duration and frequency of open and closed states with the drop count feedback from sensors, the system simulates continuous infusion while enhancing accuracy, improving energy efficiency, and minimizing mechanical fatigue.
The flow regulator is configured to wirelessly transmit operational data—such as real-time flow rate, potential occlusions, blockages, or other adverse events—to a remote monitoring system. This system is typically installed at a centralized location, such as a nursing station, and serves as an interface for healthcare professionals to oversee and administer the fluid delivery process.
The remote monitoring logic unit can display real-time infusion parameters, generating alerts in response to abnormal conditions (e.g., flow obstruction, deviation from prescribed flow rate, or system malfunction), and supporting prompt clinical intervention. In certain embodiments, the system may further permit remote configuration or adjustment of flow control settings, enabling healthcare personnel to manage the device without requiring direct physical access.
The ML model is a lightweight neural network trained on signal frequency and intensity variance. The flow state classification is performed in real-time with adjustable confidence thresholds.
The drop signals are pre-processed into digital events using a comparator circuit.
A calibration system for an IV fluid delivery device, comprises a logic interface configured to receive an input value representing observed flow error due to drop factor deviation, and a correction algorithm adapted to adjust the effective drop-to-volume mapping used in flow rate computation, wherein the adjusted drop factor is stored and applied to subsequent flow calculations to improve delivery accuracy. the modulation algorithm implements pulse-width modulation (PWM) logic to simulate continuous flow.
The calibration value is determined by weighing a volume of delivered fluid and comparing it to drop count. The logic allows storing calibration profiles for different IV set manufacturers.
The calibration is only permitted by authorized personnel through password-protected access.
The actuator includes a magnetic clamp for attachment to an IV stand and a mechanical failsafe clip to shut off flow manually.
The wireless monitoring system for an infusion control device, comprising: a communication module configured to transmit infusion data, a remote monitoring application configured to receive and display real-time data including flow rate, device status, and alerts, wherein the application generates alarms for anomalies and enables remote adjustment of flow parameters.
The wireless protocol comprises BLE, Wi-Fi, or other low-power wireless technologies. The remote interface displays multiple infusion device statuses on a single dashboard. The alerts are triggered upon detection of no flow, occlusion, or deviation from the prescribed rate. The remote commands are restricted to authenticated users only.
It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein.
Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non- exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.
The present disclosure is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the present disclosure when combined with information and knowledge available to the person having ordinary skill in the art and thus it is intended by the appended claims to cover all such modifications and adaptations which fall within the scope of the present subject matter.

ADVANTAGES OF THE PRESENT INVENTION
Precision infusion devices generally belong to two categories, 1) Infusion pumps that automatically control the fluid flow rate based on a pre-fed rate and 2) flow measuring devices that alert the healthcare practitioner upon rate variations.
Large volume infusions pumps require frequent calibration to maintain accuracy, The proposed mechanism requires no calibration over time. Also, since the custom value reduces the power requirement of actuator, the value can be driven by low torque motors, thereby reducing the cost of the system and power consumption requirements, this also helps the device to have longer battery life making it more portable.
The existing IR-based drip monitoring or measuring devices cannot distinguish between the states of continuous flow and no flow, i.e., if there are no distinct drops identifiable by the IR sensor it would be read as no flow. The drop sensors used in IV flow measuring devices generally employ IR sensors to count the drops. In IR drop sensing, the IR transmitter passes light through the drip chamber and when a drop breaks the light, the event is measured by the IR receiver. If there are no drops that interrupt the light in the drip chamber, the receiver will not detect any events. Hence a continuous flow of fluid through the drip chamber is detected by the IR drop sensor as no-flow or lack of drops by the IR-based drop counter. With the help of a Machine Learning algorithm, the proposed system can distinguish between the state of continuous fluid flow and the state of no flow. This can help to make the device more accurate in terms of generating alarms.
control logic unit calibration of IV set’s drop factor: Existing flow meters and infusion monitors reflect the cumulative error from the error in the drop factor of the IV set. Drop factor (DPF) is a unit that denotes the volume of fluid in each drop passing through the drip chamber of an IV set and error in this parameter impacts flow measurement when fluid volume is calculated by counting drops. Usually, a discrepancy of +/- 10% is allowed in the drop factor of standard IV sets available in the market. Existing flow meters don’t have any means to identify or correct this error.
TECHNICAL ADVANCEMENT
The infusion control and monitoring mechanism is proposed as an advanced version of infusion monitors and a cost-effective alternative to large volume infusion pump. The following features makes the innovation advanced to existing devices.
Intelligent sensing mechanism: The sensing mechanism of the controller is equipped with Machine Learning based model to understand no flow and full flow in IV drip chamber. The sensor interface has a Software based calibration option. This allows users to add to feed the percentage error of drop size variations to the sensing device. It helps device to display volume readings of fluid infused accurately while monitoring.
Custom-made IV sets with predefined flow rates: The IV set used in the system consists of a Drip Chamber, IV tube and a control value to allow the flow of liquid at predefined rates. This can be done as a silicone segment which allows two flow rates, fully open maximum and closed positions. This can also be done a linear step based system or dial based system with multiple floe rate options.
Electronics actuation: The system is also equipped with an electronics actuator controlled by control logic unit to achieve the desired flow rates by switching the flow rates in the IV set. It also has a magnetic clamping option to IV set with a female member to reduce the risk of fall of the system. ,CLAIMS:Claims:
1. A machine learning (ML) model enabled bio-medical system (1) for controlling and monitoring of intravenous (IV) fluid from an IV bag (104) into a patient body wirelessly,
characterised in that said system (1) comprises:
a customised IV set (105) attached to the outlet of the IV bag (104), wherein the IV set (105) comprises a drip chamber (112) to receive a fluid from the outlet of the IV bag (104), any one control valve (111, 129, 130) to control the flow of the fluid falling into the chamber (112) as drops per minute (dpm) and an IV tubing (114) to pass the fluid therefrom,
wherein the control valve (111) being a silicon tubing valve configured with a lateral pinching head for reliable constriction,
wherein the control valve (130) being rectangular in shape and comprising a pair of adjacent first and second chambers (116, 117) separated by an array of gates or openings (118) of different widths (W1, W2), wherein the first chamber (116) proximal to the drip chamber (112) being connected via an inlet port (119) to the chamber (112), wherein the second chamber (117) distal to the drip chamber (112) being configured with an outlet (120) for fluid discharge therefrom, wherein the first chamber (116) being configured with a rectangular sliding block (115) aligned parallel to the gate array (118),
wherein the control valve (129) being a rotary modulation valve and comprising a circular housing with a pair of principal ports, an ingress orifice (122) for fluid entry and an egress port (121) for fluid discharge, wherein a plurality of gates or flow channels (122) of varying widths being positioned at the inlet end proximal to the drip chamber (112), wherein an angular closure element (123) being concentrically aligned within the valve chamber and rotatably mounted about the valve’s (129) central axis, wherein the rotational displacement of the closure element (123) modulates fluid flow by selectively revealing or occluding individual gate openings (122) in the positions (124a, 124b, 124c),
a device (100) attached to the IV set (105), wherein the device (100) comprises:
an actuator (107) to control the valve (111, 129, 130) in the custom IV set (105) for controlling the drops falling in the drip chamber (112) in the IV set (105), wherein the valve (111, 129, 130) is positioned and secured by a hinged or rotating door (128) integrated into the housing of the device (100),
an infrared (IR) light-emitting diode (LED) (109) acting as an emitter and a photodiode (110) acting as a detector, positioned on opposite sides of the fluid path in the chamber (112) so that fluid drops (108a) fall through an optical axis between the emitter (IR) LED (109) and the detector photodiode (110), wherein the drop (108a) passing between the IR LED (109) and the photodiode (110) causes a reduction in the received light intensity on the photodiode (110) and the variation in light being converted into an electrical signal (E) by the photodiode (110),
a control logic unit to control the flow regulation by the actuator (107) to: (i) alternately compress and release a segment of silicone tubing valve (111) to restrict flow without continuous force application, or (ii) modulate fluid flow by rotating the closure disc (123) by driving a motor (125) to dynamically adjust the gate (122) access at predetermined intervals to maintain the desired flow profile in the rotary valve (129) or (iii) translate the block (115) horizontally across the gates (118) or vertically along the gates (118) to selectively expose or block specific channels or gates (118) in the rectangular valve (130), thereby shifting between pre-calibrated flow rate settings to generate the conditions (a) a ‘dropping’ condition (108a), (b) a ‘continuous flow’ condition (108b) and (c) a ‘no flow’ condition (108c),
a printed circuit board (PCB) embedded with a microcontroller (M) to process the electrical signal (E) corresponding to each drop (108a) to determine the presence and characteristics of the fluid flow in different conditions (a-c), wherein the microcontroller (M) being integrated with an ML model trained with data of the conditions (a-c) (108a-c) on various IV tubes and lighting conditions for reliable discrimination between the conditions (a-c) (108a-c), and
a wireless connection module to send the status of all infusions to an observer station display (106) or a remote monitoring system and alert accordingly.
2. The system as claimed in claim 1, wherein the angular position of the element (123) determines the exposed cross-sectional area, directly correlating with the flow rate of the fluid.
3. The system as claimed in claim 1, wherein the control logic unit being configured to evaluate real-time flow as a function of drop count and elapsed time to calculate actual flow rate.
4. The system as claimed in claim 1, wherein the flow regulation employs intermittent modulation to achieve target average flow rates.
5. The system as claimed in claim 1, wherein the ML Model is trained on signal frequency and intensity variance.
6. The system as claimed in claim 1, wherein flow state classification is performed in real-time with adjustable confidence thresholds.
7. The system as claimed in claim 1, wherein the actuator (107) includes a magnetic clamp for attachment to an IV stand and a mechanical failsafe clip to shut off flow manually.
8. The system as claimed in claim 1, wherein the modulation implements pulse-width modulation (PWM) logic to simulate continuous flow.
9. The system as claimed in claim 1, wherein the wireless monitoring system for an infusion control device, comprises a communication module configured to transmit infusion data, a remote monitoring application configured to receive and display real-time data including flow rate, device status, and alerts, wherein the application generates alarms for anomalies and enables remote adjustment of flow parameters.
10. The system as claimed in claim 1, wherein the wireless protocol comprises BLE, Wi-Fi, or other low-power wireless technologies.
11. The system as claimed in claim 1, wherein the remote interface displays multiple infusion device statuses on a single dashboard.
12. The system as claimed in claim 1, wherein alerts are triggered upon detection of no flow, occlusion, or deviation from the prescribed rate.