Automated system for airway secretion management and ventilation synchronization

Abstract

The invention relates to an automated suctioning system (100) for simultaneous suctioning (in pulsatile mode) and ventilation of tracheal secretions, improving airway management in mechanically ventilated patients. It includes a vacuum pump (101), a modified multilumen endotracheal tube (102) with valves for suction control, an oral suction adopter (103), subglottic suction tubing (104), and a ventilation-suction switch (105) to synchronize suctioning and ventilation. A lumen obstruction detector (106) identifies obstructions, while an RTOS-based microcontroller (107) manages real-time tasks. Pressure sensors (108, 109) monitor suction levels and detect blockages, and a liquid dispensing system (110) delivers mucolytic agents. A user interface device (111) provides feedback and alerts. The system dynamically adjusts suction pressure, ensuring patient safety, reducing ventilation interruptions, and enhancing secretion management in critical care settings.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY

[0002] The present application does not claim priority from any application.

[0003] FIELD OF THE INVENTION

[0004] The present invention relates to medical devices for airway management in mechanically ventilated patients. Specifically, it pertains to an automated system and method for synchronized airway suctioning without manual intervention using a modified tracheal tube to facilitate and optimize airway clearance and enhance patient safety in critical care settings.

[0005] BACKGROUND AND INTRODUCTION

[0006] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0007] Mechanical ventilation is a critical and life-sustaining intervention used to support patients with compromised respiratory function, often resulting from conditions such as chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), pneumonia, or neurological disorders. For patients who are unable to maintain adequate oxygenation and ventilation on their own, mechanical ventilation helps ensure that their lungs remain inflated and that sufficient oxygen is delivered to their bloodstream. Thus, mechanical ventilation has proven essential in supporting these patients, managing their airway health is equally vital. A key aspect of this care involves the periodic manual suctioning of the airways to clear accumulated secretions, which, if left untended, can obstruct the airway, contribute to infections especially ventilator-associated pneumonia, and impede the effectiveness of mechanical ventilation. Traditional suctioning processes, whether performed manually or implemented through automated systems with limited capabilities, present significant challenges that can compromise patient safety, care quality, and healthcare provider efficiency.

[0008] A primary concern with conventional suctioning techniques lies in the reliance on manual handling of patients to remove secretions from multiple anatomical locations, including the tracheal, oral, and subglottic regions. Repeated patient handling increases the risk of infection, especially when suction catheters are reused over multiple days, a common practice in resource-limited settings. This not only exposes patients to healthcare-associated infections but also imposes a significant financial burden fortreatments.

[0009] Manual suctioning often involves healthcare providers adjusting suction levels based on visual inspection or patient feedback, which can result in unpredictable, inconsistent, inadequate, or excessive suction pressures. Excessive suction pressures can cause trauma to the airway, including mucosal damage, bleeding, or even airway collapse, while insufficient suction pressures may fail to clear secretions effectively, leading to blockages and impaired gas exchange. The lack of automation in regulating suction pressure also increases the potential for human error and variability, undermining patient safety.

[0010] Another major issue with existing conventional systems is the lack of synchronization between suctioning and mechanical ventilation. Suctioning, if not properly timed, can interrupt the ventilatory cycle, leading to a disruption in the patient’s oxygenation and ventilation. This disruption increases the risk of hypoxemia (a condition where oxygen levels in the blood fall dangerously low) and barotrauma (lung injury caused by pressure fluctuations), both of which are serious complications that can prolong patient recovery and increase mortality. Conventional systems fail to integrate suctioning and ventilation switching effectively thereby creating a clinical gap where the timing of suctioning may inadvertently interfere with the patient’ s respiratory stability. The manual nature of traditional suctioning techniques places a significant burden on healthcare providers. In critical care settings, such as intensive care units (ICUs) or emergency departments, healthcare professionals are often required to perform suctioning at frequent intervals, particularly in patients with high secretion production or impaired cough reflexes. This constant need for suctioning imposes a physical and cognitive load on caregivers, increasing the likelihood of fatigue, distraction, and human error. With manual suctioning, there is also the risk of delays between suctioning attempts, leading to suboptimal care. The repetition of this task throughout a shift also detracts from caregivers’ ability to focus on other critical aspects of patient care, reducing overall efficiency and quality of service.

[0011] Further, many conventional suction systems lack advanced monitoring features capable of detecting real-time variations in suction pressure, obstructionin the system, or malfunctions of key components such as the suction catheter or tubing. This absence of comprehensive monitoring leaves healthcare providers vulnerable to undetected issues, such as suction system failures or pressure deviations, which could compromise patient care. Without effective alerts or feedback mechanisms, caregivers may not be made aware of issues in time to take corrective action, potentially putting patients at risk of further complications.

[0012] Michael A. Gentile RRT FAARC et al. (2009) is an Non Patent Literature (NPL) that discusses advancements in endotracheal tubes (ETTs), including subglottic suction ETTs with larger suction lumens to prevent occlusion and silver-coated ETTs that reduce ventilator-associated pneumonia (VAP) risk by 35.9%. However, the tubes described have a larger outer diameter (0.8-1.0 mm), increasing external dimensions. While it suggests altering the ETT cuff shape to reduce secretion leakage, it does not evaluate the impact on subglottic suctioning failure or tracheal / laryngeal injury. However, the NPL does not diclaose the time-based or pressure-based suctioning, a backpressure sensor for obstructiondetection, a mucolytic agent dispensing system, automated suctioning, or respiratory health monitoring software, which address unmet needs and differentiate the invention. US20120024293 discloses a suction lumen associated with the tracheal tube that terminates in an opening proximal to the inflatable cuff. It also includes a display unit configured to indicate a blockage in the suction lumen when there is no pressure drop between the first and second pressure sensors for a specific time period, employing a principle analogous to the suctioning control system of the present invention. Additionally, it describes a sensor positioned on the tube between the proximal shoulder of the cuff and the opening, capable of detecting and outputting information related to the presence of secretions on the tube. However, it fails to disclose a modified endotracheal tube (ETT) and a liquid dispensing system designed to deliver mucolytic agents, which are essential for effective secretion suctioning.

[0013] US20120180791 A Idiscloses an endotracheal tube with integrally formed ventilation, suction, and inflation lumens. The ventilation lumen is non-circular with a distinct cross-sectional area, while the suction lumen is circular. It also describes projecting portions with differing cross-sectional shapes and a one-piece ventilation connector. However, it does not disclose the modified endotracheal tube (ETT) and lacks features such as the suctioning control system and respiratory health monitoring software integrated with the secretion suctioning system.

[0014] US20140150782A1 discloses an endotracheal tube and airway cleaning system, including a coupling adapter with a ventilator port, suction port, and distal port, as well as a closed suction system module with a control unit that manages cleaning member expansion and suction. The system also features a suction catheter with a diameter less than 50% of the inner diameter of the body-inserted tube. However, it does not disclose the modified endotracheal tube (ETT) or secretion suctioning system, nor does it include time-based or pressure-based variable suction, a backpressure sensor for blockage detection, a liquid dispensing system for mucolytic agents, or automatic suctioning.

[0015] Given these challenges, there is a critical need for an advanced airway suctioning system that addresses the safety, efficiency, and monitoring gaps inherent in current suctioning technologies. The ideal solution should provide consistent and controlled suction pressures, be seamlessly integrated with mechanical ventilation systems, improve workflow efficiency for healthcare providers, and incorporate real-time monitoring with automatic alerts to identify and resolve potential issues promptly.

[0016] The presently disclosed inventionis designed to meet these needs by incorporating cutting-edge features such as Real-Time Operating System (RTOS)-based task management, intelligent control algorithms, and real-time feedback mechanisms. By automating the suction process, the instant invention ensures that suction pressures remain consistent and within safe limits, while also synchronizing suctioning operations with ventilation cycles to prevent interruptions. The system’s advanced task management, based on RTOS, prioritizes critical tasks such as suction control and patient safety, while simultaneously allowing for less timesensitive functions to be managed in the background, thereby improving overall workflow efficiency.

[0017] Advantages of the Invention:

[0018] Enhanced safety by precise negative pressure or vacuum control preventing airway damage; synchronization with ventilation minimizes hypoxemia risks; efficient by close controlledautomation that reduces caregiver workload and errors; targeted suction by tracheal tube with valves enables precise secretion removal; real-time monitoring alerts obstructions, pressure deviations, and malfunctions; seamless integration by ventilation- suction switch ensuring smooth operation triggered via controlled algorithm; uer-friendly by intuitive touchscreen interface with real-time data display; reliable due to redundant components and compliance with medical standards; and future-ready as itsupports Al and remote monitoring enhancements.

[0019] OBJECTIVES

[0020] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

[0021] An object of the present disclosure is to provide system for suctioning and ventilation in mechanically ventilated patients by combining automation, precision control, and real-time monitoring.

[0022] Another object of the present disclosure is to provide a system with modified multilumen endotracheal tube having integrated valves that ensure selective suction, prevent unintended airway obstruction and enhance patient comfort

[0023] Still another object of the present disclosure is to provide a system with ventilation-suction / aspiration switch that ensure seamless mode transition and maintain continuous ventilation.

[0024] Still another object of the present disclosure is to provide a system with endotracheal tube lumen obstruction detector to detect obstructions in the endotracheal tube, trigger timely alerts and improve patient safety.

[0025] Still another object of the present disclosure is to provide a system with RTOS- based task management for real-time control of critical functions, efficient task execution and seamless task synchronization.

[0026] Yet another object of the present disclosure is to provide a system with dynamic pressure regulation to achieve precise suction pressure and optimize pressure adjustments. Yet another object of the present disclosure is to provide a system with communication and data exchange to enable reliable data transfer

[0027] Yet another object of the present disclosure is to provide a system with user interface device that provide touchscreen display, intuitive control, real-time monitoring and deliver visual and audible alarms.

[0028] Yet another object of the present disclosure is to provide a system with integrated safety features that includes hardware redundancy, software watchdog timers, and emergency shutdown protocols.

[0029] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

[0030] SUMMARY OF THE INVENTION

[0031] The present application relatesto an automatic suctioning system (100) for simultaneous suctioning in sync with ventilation for tracheal secretions comprising a vacuum pump (101); modified multilumen endotracheal tube (102); oral secretion suction adopter (103) placed in oral cavity; a tubing (104) placed above a cuff; a ventilation-suction / aspiration switch (105); an endotracheal tube lumen obstruction detector (106);a real-time operating system (RTOS) (107) based microcontroller; a vacuum sensor (108); a positive pressure sensor (109);a liquid dispensing system (110) to dispense mucolytic and anti-biofilm agents in lumen and beyond the tracheal tubing; andauserinterface device (111). Further, it relates to the system that adjust suction pressure at the tracheal tube in real-time based on feedback from the pressure sensors; and suctioning and ventilation are synchronized to avoid ventilation interruptions.

[0032] Further, the present invention relates to a method (200) for automated suction control using a tracheal tube in a mechanically ventilated patient, comprising the steps of operating both lumens in ventilation mode during an initial state (201); triggering suctioning based on either a pre-set interval or detection of lumen obstruction due to secretions (202); executing suctioning in three cycles (203) comprising Cycle 1 by disabling ventilation in both lumens, switching the secondary lumen to suction mode, building suction pressure to a pre-set value, and performing pulsative suctioning (203a), Cycle 2 by resuming ventilation in the primary lumen to push secretions towardsthe secondary lumen while maintaining oxygenation (203b) and Cycle 3 by re-activating suction in the secondary lumen and disabling ventilation in the primary lumen to remove remaining secretions (203c); returning both lumens to ventilation mode post-suctioning, continuing ventilation unless interrupted by a blockage or the next scheduled suctioning cycle (204) and coordinating suctioning and ventilation using an RTOS-based microcontroller for real-time task management and synchronization (205).

[0033] BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING

[0034] Theautomatic suctioning system (100) and a methodfor automated suction control using a tracheal tube in a mechanically ventilated patient of the present disclosureare now described with the help of the accompanying drawing, in which:

[0035] Figure lillustrates the schematic diagram for the functional layout of an automated suctioning system for tracheal, oral, and subglottic suctioning, integrated with a ventilator systemin accordance with the present disclosure;

[0036] Figure 2 illustrates the Smart Suction System, featuring a Main Control Unit for operational settings and real-time monitoring, connected to Fluid Collection Canisters via a Tubing System for suctioning oral, subglottic, and tracheal secretions. The system includes an Oral and Subglottic Suction Module for sequential suctioning, a Tracheal Suction Module integrated with the modified Endotracheal Tube (ETT) for automatic secretion removal, and an Obstruction Detection Sensor. Caregiver notifications and system updates are displayed on the User Interface. Figure 3 (a) illustrates the frontal view highlighting the dual lumen structure with the proximal endsof a multi-lumen endotracheal tube in accordance with the present disclosure;

[0037] Figure 3 (b) illustrates the rear view illustrating the alignment of the lumens and their separationof a multi-lumen endotracheal tube in accordance with the present disclosure;

[0038] Figure 2(c) illustrates the isometric view of the tube showing cuff and lumen separation positionsof a multi-lumen endotracheal tube in accordance with the present disclosure;

[0039] Figure 3(d) illustrates the lateral view demonstrating the flexible nature of the tube and its tubing connectionsof a multi-lumen endotracheal tube in accordance with the present disclosure;

[0040] Figure 3(e) illustrates the horizontal view emphasizing the dual lumen pathway and their individual ports for ventilation of a multi-lumen endotracheal tube in accordance with the present disclosure;

[0041] Figure3(f) illustrates the close-up view of the distal end, showing the inflation cuff and the openings of the tube with partition of a multi-lumen endotracheal tube in accordance with the present disclosure;

[0042] Figure 4 (a) illustrates the side view displaying the overall curvature of the tube, designed to align with the anatomical structure of the airwayof the modified double-lumen endotracheal in accordance with the present disclosure;

[0043] Figure4 (b) illustrates the front view highlighting the symmetrical design of the proximal end with separate lumens for tracheal and subglottic suctionin a modified double-lumen endotracheal in accordance with the present disclosure;

[0044] Figure4 (c) illustrates the top view providing a longitudinal perspective of the tube, showing the distal cuff dimensions and the lumen pathwaysin a modified double-lumen endotracheal tube for secretion management in accordance with the present disclosure;

[0045] Figure4 (d) illustrates the isometric viewof a modified double-lumen endotracheal offering a 3D visualization of the tube, emphasizing its ergonomic design and separation of suction and ventilation channels in accordance with the present disclosure;

[0046] Figure 5 (a) illustrates the side view of the ventilation-suction (VS) switch, showcasing the motor module mounted on the channels in accordance with the present disclosure;

[0047] Figures (b) illustrates the front view of the VS switch highlighting the alignment of the primary (1-way) and secondary (3-way) channelsin accordance with the present disclosure;

[0048] Figure 5 (c) illustrates the isometric view showing the compact design of the motor module with attached channels, emphasizing the modularity of the system in accordance with the present disclosure;

[0049] Figure 5 (d) illustrates the rear view demonstrating the connectivity and structural integration between the motor module and both channelsin a VS switchin accordance with the present disclosure;

[0050] Figure 5 (e)illustrates the isometric view showing the primary (1-way) and secondary (3-way) channels, controlled by the motor module in a ventilationsuction (VS) switchin accordance with the present disclosure;

[0051] Figure 4 (f) illustrates the top view showing the primary (1-way) and secondary (3-way) channels, controlled by the motor module in a VS switchin accordance with the present disclosure;

[0052] Table l:Illustrates the test results with benchtop simulated lung model for a manual suctioning method using a closed suction catheter (marketed product) in comparison with the automated suction system under different modes (device is under investigation) operated at 100 mm of Hg negative pressure using artificial tracheal secretions in accordance with the present disclosure.

[0053] DETAILED DESCRIPTION

[0054] Embodiments, of the present disclosure, will now be described with reference to the accompanying drawings. Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0055] The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises,"

[0056] "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and / or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.When an element is referred to as being "mounted on," “engaged to,” "connected to," or "coupled to" another element, it may be directly on, engaged, connected or coupled to the other element. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed elements.

[0057] The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementionedtermsmay be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.Terms such as “inner,” “outer,” "beneath," "below," "lower," "above,"

[0058] "upper," and the like, may be used in the present disclosure to describe relationships between different elements as depicted from the figures.

[0059] Airway management in mechanically ventilated patients presents challenges such as inadequate secretion clearance, increased risk of ventilator-associated pneumonia (VAP), and caregiver fatigue due to frequent manual intervention. Traditional suction systems are limited in their adaptability, precision, and monitoring capabilities, often leading to mucosal trauma or insufficient clearance. To address these challenges, the presentsystem integrates an advanced dual-lumen endotracheal tube with automated suction and monitoring features. By combining intelligent control mechanisms with innovative hardware design, the system eliminates manual intervention and enhances airway management while minimizing complications.

[0060] A non-limiting embodiment of the present disclosure is to providean automatic suctioning system (100) for simultaneous suctioning and ventilation for tracheal secretions as illustrated in in Fig (1 and 2).

[0061] In an embodiment of the present invention, an automatic suctioning system (100) comprises a vacuum pump (101). The said high-efficiency pump provides the necessary negative pressure for suctioning secretions from the airways. The vacuum pump operates in sync with the solenoid valves to maintain the desired pressure levels across different suction locations. A tracheal tubeis used to maintain an open airway in patients unable to breathe on their own or need mechanical ventilation. It is typically inserted into the trachea (windpipe) through the mouth or nose to provide a secure airway for breathing. Tracheal tubes are commonly used in surgeries, emergency situations, and for patients in critical care who require longtermrespiratory support.

[0062] In an embodiment of the present invention, an automatic suctioning system (100) comprises the modified multilumen endotracheal tube (ETT) (102) as illustrated in Fig 3(a-f) and 4(a-d) designed for simultaneous or alternating suction and ventilation, with hydrophobic features to prevent secretion adherence. It is a semi- triangular shape with a multiplelumen and steady or flexible partition that ensures flexibility and patient comfort.

[0063] Further, in the interlumenpartition is truncated before 1 cm from endotracheal tube tip / distal end wherintruncations can be extended further beyond 1 cm to 15 cm. Furthermore, the thickness of bifurcation is varied to change the flexibility aspect of the tube. Also, when suctioning is needed, one of the lumen is used for ventilation and the other lumen is used for only suctioning for few secs which switch back to ventilation again. However, both the lumens can be used for ventilation and suctioning in automated or manual suctioning procedures when required.

[0064] Further, the lumen division for double lumen endotracheal tube is possible with plurality of ratio of division for example.50:50 or 30:70. Furthermore, the hydrophobic coatings reduce secretion adhesion, and mucolytic agents enhance biofilm prevention.The said modification for adult tube adapted to any endotracheal tube and tracheostomy tube of various sizes is unlimited comprising neonatal, pediatric, geriatric patients.

[0065] In a related embodiment, the modified double lumen endotracheal tube (ETT) (102) comprises a ventilation tube with first valve located proximally to regulate airway for airflow into the trachea; and a ventilation- suction lumen with second three-way valve located at proximal end or ETT adaptor to the airway to control the suction and ventilation at a tracheal location. Further, both valves are automatically controlled by the RTOS-based system (107) to adjust suction based on the patient’s needs and real-time sensor feedback. It supports simultaneous or alternating suction and ventilation, minimizing downtime and optimizing secretion clearance in automated mode.

[0066] In a further related embodiment, the present invention discloses the modified multiple lumen endotracheal tube (ETT) (102) made up of material selected from but not limited to silicon, siliconised PVC, nylon, polyurethane polyethylene, polytetrafluoroethylene (PTFE), polycarbonate (PC), Thermoplastic Elastomers (TPE), polyetherimide (PEI), titanium, or polypropylene.

[0067] In a related embodiment of the present invention, the automatic suctioning system (100) comprises oral secretion suction adopter (103) placed in oral cavity over the ETT to suck secretions effectively.

[0068] In a further related embodiment of the present invention, the automatic suctioning system (100) comprises tubing (104) placed above a cuff for subglottic secretion suctioning.

[0069] In an embodiment of the present invention, the automatic suctioning system (100) comprises a ventilation-suction / aspiration switch (105) as illustrated in Fig 5 (a-f) attached to modified multilumen endotracheal tube (102), ventilator tubing and suction tubing for seamless switching between ventilation and suction in one or more lumen to effect secretion removal. In a related embodiment, it discloses a motor module with LED indicator on the top with a green light for ventilation going on and red light for suctioning mode is active. Further, it comprises two independent motors for switching controlled by microcontroller.

[0070] Furthermore, in a related embodiment, a primary channel with a single channel and 2 attachment knobs to toggle between ventilation on / off for ventilation tubing and secondary channel with two channels and 3 attachments knobs to toggle between ventilation and suction for the tube named as ventilation- suction tube are disclosed. Further, the primary and secondary channels to motor module are made with no interchanging positions of primary and secondary channels. Further, the seamless switching is done through ball valve mechanism, comprising primary channel with ball valve with one channel and secondary channel with ball valve having 3 holes at 120° to each other to effect multichannel switching.

[0071] In a related embodiment of the present invention, the said ball valve of ventilation- suction / aspiration switch (105) is made of the medical grade hydrophobic material selected from but not limited to TEFLON, or stainless steel or titanium or platsic.

[0072] In an embodiment of the present invention, the automatic suctioning system (100) comprises an endotracheal tube lumen obstruction detector (106)that monitors the airflow through the endotracheal tube, identifying any blockages caused by secretions, kinks, or other obstructions.

[0073] In a related embodiment, the endotracheal tube (ETT) lumen obstruction detector (106) is integrated with a smart suction system comprising highly advanced sensors for accurate pressure measurements; and a light-dependent resistor (LDR) to monitor secretion movement within the lumen in such a way that system identifies obstruction by accounting changes in peak inspiratory pressure (PIP) caused by lumen obstructions and a LDR tracks the movement of secretions through the suction tube.

[0074] Further, in a related embodiment, narrowing of internal diameter of themodified ETT (102) by secretions or blockages causing backpressure is detected by the pressure sensor and data processed by a microcontroller to provide a real-time obstruction percentage. Further, an advanced predictive analysis algorithm that calculates percentage of obstruction informed by computational fluid simulations to model pressure changes and continuously transmits blockage data to the smart suction system, and displayed as a percentage, allowing caregivers to respond promptly is also disclosed. Further, in an embodiment, endotracheal tube lumen blocker detector (106) is compatible with endotracheal tubes (ETT) and tracheostomy tubes with variability of their size ranging from 2 mm to 50 mm for ETT & 2.0 mm to 50 mm for tracheaostomytubes and wide range of patients not limited to adults, pediatric patients & Neonates, geriatric patients including both human and animal (including megavertebrates & marine animals). Further, the optimal ventilation performance and reduced risks of airway obstructions is ensured by real-time obstruction detection and seamless integration with suction systems. Further, in an embodiment, the bacterial filters are attached on either end of the endotracheal tube lumen obstruction detector (106) to prevent cross contamination of the system with the microbes.

[0075] In an embodiment of the present invention, the automatic suctioning system (100) comprises a real-time operating system (RTOS) (107) based microcontroller for managing and prioritizing tasks related to suctioning, ventilation, and system monitoring. Further, upon detecting a blockage, the system promptly triggers alarms (both visual and audible), notifying healthcare providers about the obstruction. This immediate feedback allows for quick intervention, preventing the escalation of potentially dangerous situations like hypoxia. Furthermore, by ensuring that the airway remains patent during mechanical ventilation and suctioning, the detector plays a vital role in preventing complications such as airway collapse or insufficient removal of respiratory secretions, both of which could lead to severe consequences. Also, enhance workflow and monitoring. Said feature contributes to the continuous monitoring of airway patency, reducing the need for manual checks, and ensuring that patient safety is maintained without disrupting the workflow of medical staff.

[0076] In a related embodiment, the RTOS-based system (107) synchronizes suctioning with mechanical ventilation with suctioning not interfering with ongoing ventilation cycles. Further, it automatically switches between suction and ventilation modes with pre-set conditions or manual input from the healthcare provider, for preventing hypoxemia and barotrauma. In an embodiment of the present invention, the automatic suctioning system (100) comprises a vacuum sensor (108) to monitor negative suction pressures at the tracheal, subglottic and oral suction tube. It continuously measures the negative pressure at each suction location and provides feedback to the system, ensuring the desired vacuum level is maintained.

[0077] The system targets three suction locations — oral, subglottic, and tracheal — and applies suction sequentially to these sites. Each location has a dedicated solenoid valve that opens and closes based on the need for suction. Sequential suctioning ensures that no two locations are suctioned simultaneously, preventing crosscontamination between sites. For example, oral secretions are not allowed to mix with subglottic secretions, as this could introduce pathogens into the lower respiratory tract. When the pressure at any location exceeds the desired level, the buffer solenoid valve opens to release excess negative pressure. This is especially important when adjusting pressure levels for delicate tissues in the airway.

[0078] Further, the suction pressure is adjustable in the range of 5 mrnhg to 450 mrnhg at the tracheal tube, and the system can toggle between continuous suction and pulsative suction modes.The healthcare worker can adjust the suctioning interval ranging from 1 minute to 240 minutes, depending on the patient’s condition. The intervals define how frequently suction is applied at each location.

[0079] Furthermore, the suctioning system (100) in the pulsative mode simulates natural airway clearing by alternating between suction and pause intervals, enabling more efficient and less traumatic suctioning. The Proportional-Integral-Derivative (PID) algorithm constantly monitors the negative pressure and adjusts the vacuum pump and solenoid valves accordingly to maintain the set pressure level. The proportional term provides an immediate response to pressure deviations, the integral term corrects any cumulative errors over time, and the derivative term predicts future errors to smooth out the response. PID auto-tuning algorithm calculates optimal PID values based on real-time system performance. It adapts to changing conditions, such as variations in airway resistance or environmental fluctuations in temperature and humidity.

[0080] In an embodiment, suction pressure at the modified multilumen endotracheal tube (102) is adjusted based real-time parameter such as patient- specific settings, such as age, weight, and clinical condition; and feedback from the pressure sensors on current airway pressure. Further, the remote monitoring and control capabilities, allow healthcare providers to monitor and adjust suction pressures and valve positions from a central workstation or mobile device, for patient management in multi-patient environments.

[0081] In an embodiment of the present invention the automatic suctioning system (100) comprises a liquid dispensing system (110) to dispense mucolytic and anti-biofilm agents in lumen and beyond the tracheal tubing through the smart suction system in a controlled manner within the endotracheal tube lumen to remove thick tracheal secretions.

[0082] In an embodiment of the present invention, the automatic suctioning system (100) comprises a user interface device (111) to provide touch screen display, real-time monitoring, system alerts, and feedback to healthcare providers. It allows healthcare workers to adjust suction parameters, monitor system performance, and receive alerts. The interface is designed to be user-friendly, with real-time data and adjustable settings clearly visible.

[0083] In another embodiment, the multiple suctioning protocols are possible with smart suction system to remove secretions effectively from and beyond artificial airways of variable sizes and shapes used for plurality of population including animals.

[0084] In one illustrative embodiment, in accordance with the present disclosure, a method (200) for automated suction control using a tracheal tube in a mechanically ventilated patient, comprising the steps of

[0085] • operating both lumens in ventilation mode during an initial state (201); • triggering suctioning based on either a pre-set interval or detection of lumen obstructions (202);

[0086] • executing suctioning in three cycles (203) comprising: a. cycle 1 by disabling ventilation in both lumens, switching the secondary lumen to suction mode, building suction pressure to a pre-set value, and performing pulsative suctioning (203a). b. cycle 2 byresuming ventilation in the primary lumen to push secretions towards the secondary lumen while maintaining oxygenation (203b); and c. cycle 3 byre-activating suction in the secondary lumen and disabling ventilation in the primary lumen to remove remaining secretions (203c);

[0087] • Returning both lumens to ventilation mode post-suctioning, continuing ventilation unless interrupted by a obstructionor the next scheduled suctioning cycle (204); and

[0088] • coordinating suctioning and ventilation using an RTOS-based microcontroller for real-time task management and synchronization (205);

[0089] Wherein the smart suction system can work standalone or can be integrated into ventilators to improve it’ s functionalities

[0090] In one embodiment of the method (200), the step of operating both lumens in ventilation mode during an initial state (201) is disclosed.

[0091] In a related embodiment of the method (200) the step of triggering suctioning based on either a pre-set interval or detection of lumen blockage (202) is disclosed.

[0092] In accordance with another embodiment of the method (200), the step of executing suctioning in three cycles (203) further comprising the steps ofcycle 1 bydisabling ventilation in both lumens, switching the secondary lumen to suction mode, building suction pressure to a pre-set value, and performing pulsative suctioning (203a); cycle 2 byresuming ventilation in the primary lumen to push secretions towards the secondary lumen while maintaining oxygenation (203b); and cycle 3 byre-activating suction in the secondary lumen and disabling ventilation in the primary lumen to remove remaining secretions (203c) is diclosed.

[0093] In yet another embodiment of the method (200), at a step (204), returning both lumens to ventilation mode post- suctioning, continuing ventilation unless interrupted by a blockage or the next scheduled suctioning cycle (204) is dislclosed.

[0094] In yet another embodiment of the method (200), at step (205) ofcoordinating suctioning and ventilation using an RTOS-based microcontroller for real-time task management and synchronization (205). is disclosed.

[0095] Examples:

[0096] The following examples have been included to provide illustrations of the presently disclosed subject matter. In light of the present disclosure and the general level of skill in the art, those of skill will appreciate that the following examples are intended to be exemplary only and that numerous changes, modifications and alterations can be employed without departing from the spirit and scope of the presently disclosed subject matter.

[0097] System Architecture

[0098] The presently disclosed system integrates both hardware and software components, working cohesively to deliver real-time suction management. The architecture has been designed with an emphasis on reliability, precision, and patient safety.

[0099] I. Hardware Components

[0100] 1. Microcontrollers:

[0101] The microcontroller serves as the main controller, managing vacuum control, sensor data acquisition, PID regulation, and task scheduling using FreeRTOS for multitasking. The microcontroller board handles the positive pressure sensor, which detects obstructions or airway issues, communicating with the for real-time feedback and action. The microcontroller manages the ventilation-suction switch, ensuring seamless operation between modes while sending real-time mode data to the microcontroller.

[0102] 2. Vacuum Pump:

[0103] The Mini Vacuum Pump provides the required negative pressure for suctioning airway secretions. Operating in sync with solenoid valves, it maintains desired pressure levels across suction locations.

[0104] 3. Solenoid Valves:

[0105] Four solenoid valves are strategically assigned for different purposes:

[0106] • Tracheal Solenoid 1 manages suction at the tracheal site.

[0107] • Subglottic Solenoid 2 handles suction in the subglottic region, reducing the risk of subglottic secretions pooling (a common cause of VAP).

[0108] • Oral Solenoid 3 manages oral secretion control.

[0109] • Buffer Solenoid 4 releasing excess negative pressure during sudden fluctuations.

[0110] 4. Pressure Sensors:

[0111] The vacuum sensor ensures precise monitoring and maintenance of negative pressure at each suction location. A positive pressure sensor detects abnormal pressure increases in the airway, signaling potential obstructionthat could compromise patient safety.

[0112] 5. Pinching Mechanism:

[0113] A servo-driven pinching system adjusts suction flow rates by pinching suction tubing. This provides precise control and prevents over- suctioning.

[0114] 6. User Interface:

[0115] A capacitive touchscreen serves as the user interface, allowing healthcare workers to adjust suction parameters, monitor performance, and receive alerts. The interface is designed for ease of use, displaying real-time data and adjustable settings.

[0116] 7. Relay Circuits and Level Shifters: These components eennssuurree sseeaammlleessss voltage conversion between the microcontroller (3.3V) and devices requiring higher voltages (e.g., 5V solenoids), ensuring consistent operation.

[0117] II. Software Architecture

[0118] 1. FreeRTOS:

[0119] The microcontroller leverages Free RTOS for task management, enabling concurrent functions such as suction control, pressure monitoring, and display updates. RTOS ensures real-time performance through efficient multitasking and prioritization.

[0120] 2. PID Control Algorithm:

[0121] The PID algorithm dynamically adjusts vacuum pressure at each suction site, maintaining stable operation by fine-tuning the proportional, integral, and derivative parameters. An auto-tuning feature adapts the system to variations in airway resistance and environmental conditions, ensuring robust performance.

[0122] 3. Communication Protocols:

[0123] I2C, UART, and SPI facilitate communication between themicrocontrollers, and peripheral devices like sensors and solenoid valves.

[0124] III. Suction Control and Pressure Management

[0125] 1. Suction Locations and Sequential Control:

[0126] The system targets three suction sites — oral, subglottic, and tracheal — and applies suction sequentially to prevent cross-contamination. Each site is equipped with a solenoid valve to control suction precisely.

[0127] 2. Adjustable Suction Parameters:

[0128] The system operates within a negative pressure range of 5^450 mmHg, accommodating diverse patient needs from neonates to adults. Suction intervals are customizable between 1-240 minutes, and a pulsative mode offers controlled bursts of suction to reduce mucosal injury.

[0129] 3. Buffer Solenoid Functionality: The buffer solenoid releases excess negative pressure when levels exceed the set threshold, especially during delicate adjustments.

[0130] IV. Task Management and Optimization

[0131] 1. Task Breakdown and Prioritization:

[0132] • Vacuum Pump and Solenoid Control Task: Highest priority, ensuring precise pressure control and solenoid operation.

[0133] • PID Regulation and Pinching Task: Co-priority with vacuum tasks to maintain real-time pressure adjustments.

[0134] • Sensor Data Acquisition Task: Moderate priority, collecting sensor data at regular intervals for analysis.

[0135] • Communication Task: Handles data exchange between microcontrollers, ensuring efficient feedback and action.

[0136] • Display Update Task: Lowest priority, updating the touchscreen interface during idle periods.

[0137] 2. RTOS synchronization and optimization:

[0138] Semaphores and mutexes prevent data conflicts, while non-critical tasks are delayed during idle time to conserve CPU resources. Critical functions like suction control and PID regulation always preempt lower-priority tasks for real-time responsiveness.

[0139] V. User Interface and Monitoring

[0140] The touchscreen allows healthcare workers to set suction parameters, monitor pressure levels, and enable features like pulsative mode. Real-time data, such as current suction pressure and countdown timers, is displayed for informed decisionmaking. The interface also provides system alerts, including blockage notifications and pressure deviations, using color-coded visual cues (green for normal, yellow for warnings, and red for critical issues) alongside audible alarms.

[0141] VI. Safety Features

[0142] 1. System Redundancy: Critical components like sensors and solenoids have redundancies to maintain functionality during failures. A software watchdog timer monitors the system for malfunctions, resetting tasks as needed.

[0143] 2. Emergency Shutdown Protocols:

[0144] In the event of a critical failure, the system halts suction operations to prevent harm, alerting the user to take manual control.

[0145] 3. Integration with Ventilators:

[0146] A ventilation-suction switch, controlled by the microcontroller, enables seamless mode transitions. The interface displays the current mode for clinician awareness.

[0147] VII. Implementation and Testing

[0148] 1. Hardware Integration:

[0149] Robust medical-grade components ensure reliability and compliance with standards like IEC 60601. Circuit design prevents electrical interference, supporting stable operation.

[0150] 2. Software Design:

[0151] RTOS ensures smooth task execution, while the auto-tuning PID algorithm adapts to changing conditions. Unit and system integration tests validate hardwaresoftware synergy.

[0152] 3. Clinical Simulations:

[0153] Tests using patient simulators evaluate system performance under real-world conditions, incorporating feedback from healthcare professionals to refine usability.

[0154] VIII. Future Enhancements

[0155] Planned updates include data logging for tracking system performance, remote monitoring capabilities for centralized management, and machine learning algorithms to personalize suction settings based on patient-specific data, making the system more adaptive and reducing manual intervention. TECHNICAL ADVANCEMENTS

[0156] The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the above description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.

[0157] The present disclosure described herein above has several technical advantages including, but not limited to, the realization of:

[0158] The invention of automatic suctioning systemand the method threrof introduces several significant technical advancements over existing prior art in the field of medical imaging:

[0159] • advanced tracheal tube with valves ensures precise suction pressure regulation, preventsblockages, and minimizes mucosal damage;

[0160] • ventilation-suction switch synchronizes suction and ventilation cycles to minimize interruptions, reducing risks like hypoxemia and barotrauma.

[0161] • endotracheal tube lumen obstructiondetector detects blockages in real-time, triggering algorithm controlledsuctioning in automate mode and alarms for immediate caregiver intervention.

[0162] • rtos-based task management ensures prioritized execution of critical functions, enhancing system efficiency and responsiveness.

[0163] • intelligent pressure control with auto-tuning provides real-time suction pressure regulation based on sensor feedback.

[0164] • touchscreen interface leads to user-friendly control of suction parameters with real-time alerts for system malfunctions and blockages.

[0165] • safety and fail-safe mechanisms includes hardware redundancy, software watchdog timers, and emergency shutdown protocols for reliable operation.

[0166] • pulsative suction and flow control offer physiological suction patterns and fine-tuned flow regulation to reduce patient trauma. • scalable design modular and compatible with existing ventilators, allowing integration and future enhancements like remote monitoring.

[0167] • comprehensive monitoring provides real-time feedback and data logging for system performance analysis and patient- specific adjustments.

[0168] The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims

WE CLAIM:

1. An automatic suctioning system (100) for simultaneous suctioning and ventilation for tracheal secretions comprising: a vacuum pump (101); modified multilumen endotracheal tube (102) with at least one valve to regulate airflow and control suctioning at the patient’s airway; oral secretion suction adopter (103) placed in oral cavity to suck secretions effectively; a tubing (104) placed above a cuff for subglottic secretion suctioning; a ventilation-suction / aspiration switch (105); an endotracheal tube (ET) lumen obstruction detector (106) with a positive pressure sensor (109) to identify obstructions within the lumen; a real-time operating system (RTOS) (107) based microcontroller for managing and prioritizing tasks related to suctioning, ventilation, and system monitoring; a vacuum sensor (108) to monitor negative pressures at the tracheal, oral and subglottic tube; a liquid dispensing system (110) to dispense mucolytic and antibiofilm agents in lumen and beyond the tracheal tubing; and a userinterface device (111) to provide real-time monitoring, system alerts, and feedback to healthcare providers: wherein the system adjust suction pressure at suction tubes in real-time based on feedback from the pressure sensors; and suctioning and ventilation are synchronized to avoid ventilation interruptions.

2. The modified multilumen endotracheal tube (102) as claimed in claim 1 comprises:a multiple lumen with semi-triangular shape with a steady or flexible partition; the lumen division for the tube in plurality of ratio of division eg. 50:50 or 30:70 hydrophobic materials coating for removing secretions; a ventilation tube with first valve located proximally to regulate airway for airflow into the trachea; and a ventilation- suction lumen with second three-way valve located at proximal end or ETT adaptor to the airway to control the suction and ventilation at a tracheal location; wherein both the valves automatically controlled by the RTOS-based system to adjust suction based on the patient’s needs and real-time sensor feedback.

3. The modified tracheal tubes as claimed in claim 1, wherein the material of modified tracheal tube is silicon, siliconised PVC, nylon, polyurethane polyethylene, polytetrafluoroethylene (PTFE), polycarbonate (PC), Thermoplastic Elastomers (TPE), polyetherimide (PEI) or titanium, polypropylene.

4. The modified tracheal tubes as claimed in claim 1, wherein distal end of the modified artificial airway transitions into a single lumen at 1 cm extendable up to 15 cm from the distal end or ET tube tip to the proximal end or ET tube adapter.

5. The suctioning system as claimed in claim 1, wherein the ventilation suction / aspiration switch comprise: a motor module with LED indicator on the top with a green light for ventilation going on and red light for suctioning mode is active; two independent servo motors for switching controlled by microcontroller; primary channel with a single channel and 2 attachment knobs to toggle between ventilation on / off for ventilation tubing; andsecondary channel with two channels and 3 attachments knobs to toggle between ventilation and suction for the tube named as ventilation- suction tube; wherein the primary and secondary channels to motor module are made with no interchanging positions of primary and secondary channels.

6. The ventilation suction switch as claimed in claim 4 is attached to modified double lumen endotracheal tube, ventilator tubing and suction tubing for seamless switching between ventilation and suction in one or more lumen to effect secretion removal.

7. The ventilation suction / aspiration switch as claimed in claim 5, wherein the seamless switching is done through ball valve mechanism, comprising primary channel with ball valve with one channel and secondary channel with ball valve having 3 holes at 120° to each other to effect multichannel switching.

8. The ball valve as claimed in claim 7 is made of medical grade hydrophobic material such as TEFLON, or stainless steel or plastics, titanium.

9. The endotracheal tube (ETT) lumen obstruction detector (106) as claimed in claim 1 is integrated with the smart suction system comprising: highly advanced sensors for accurate pressure measurements; and a light-dependent resistor (LDR) to monitor secretion movement within the lumen such that device / system identifies obstructionsby changes in peak inspiratory pressure caused by lumen obstructions and a LDR tracks the movement of secretions through the suction tube.

10. The ETT lumen obstruction detector (106) as claimed in claim 9, wherein narrowing of ETT’S internal diameter by secretions or obstructions causing back-pressure is detected by the pressure sensor and data processed by a microcontroller to provide a real-time blockage percentage.

11. The ETT lumen blocker detector as claimed in claim 10, wherein an advanced predictive analysis algorithm calculates percentage of blockage informed by computational fluid simulations to model pressure changes.

12. The ETT lumen blocker detector (106) as claimed in claim 10 continuously transmits obstructiondata to the smart suction system, and displayed as a percentage, allowing caregivers to respond promptly.

13. The endotracheal tube lumen blocker detector (106) as claimed in claim 9 is compatible with endotracheal tubes (ETTS) and tracheotomy tubes with variability of their size.

14. The system / device as claimed in claim 1, wherein the optimal ventilation performance and reduced risks of airway obstructions is ensured by realtime obstruction detection and seamless integration with suction systems.

15. The system as claimed in claim 1, wherein the suction pressure is adjustable in the range of 5 mrnhg to 450 mrnhg at the all-suction tubing, and the system toggle between continuous suction and pulsative suction modes.

16. The system as claimed in claim 1, wherein the user interface for healthcare providers comprising the steps of: selecting a specific anatomical location for suctioning via respective tubing (I l la); adjusting suction pressure in real-time (11 lb); receiving real-time alerts for blockages or pressure deviations with color-coded visual alerts and audible alarms (111c); and• enabling and disabling tracheal secretion suctioning mode, time based or threshold based as per user input (11 Id).

17. The system of as claimed in claim 1, wherein the RTOS -based system (107) synchronizes suctioning with mechanical ventilation with suctioning not interfering with ongoing ventilation cycles.

18. The system as claimed in claim 1, wherein the RTOS-based system (107) automatically switches between suction and ventilation modes with pre-set conditions or manual input from the healthcare provider, for preventing hypoxemia and barotrauma.

19. The system as claimed in claim 1, wherein the suctioning system in the pulsative mode simulates natural airway clearing by alternating between suction and pause intervals, enabling more efficient and less traumatic suctioning.

20. The as claimed in claim 1, wherein the suction pressure at the tracheal tube is adjusted based real-time parameter such as: patient- specific settings, such as age, weight, and clinical condition; and• feedback from the pressure sensors on current airway pressure.

21. The system as claimed in claim 1, wherein the remote monitoring and control capabilities, allow healthcare providers to monitor and adjust suction pressures and valve positions from a central workstation or mobile device, for patient management in multi-patient environments.

22. The system as claimed in claim 1, wherein mucolytic and anti-biofilm agents are dispensed manually or automatically through the smart suction system in a controlled manner within the endotracheal tube lumen to remove thick tracheal secretions.

23. The system as claimed in claim 1, , wherein multiple suctioning protocols are possible with smart suction system to remove secretions effectively from and beyond artificial airways of variable sizes and shapes used for plurality of population including animals.

24. A method (200) for automated suction control using a tracheal tube in a mechanically ventilated patient, comprising the steps of• operating both lumens in ventilation mode during an initial state (201);• triggering suctioning based on either a pre-set interval or detection of lumen blockage (202);• Eexecuting suctioning in three cycles (203) comprising: a. cycle 1 by disabling ventilation in both lumens, switching the secondary lumen to suction mode, building suction pressure to a pre-set value, and performing pulsative suctioning (203a).b. cycle 2 by Resuming ventilation in the primary lumen to push secretions outward from the secondary lumen while maintaining oxygenation (203b); c. cycle 3 by Re-activating suction in the secondary lumen and disabling ventilation in the primary lumen to remove remaining secretions (203c).• Returning both lumens to ventilation mode post-suctioning, continuing ventilation unless interrupted by a blockage or the next scheduled suctioning cycle (204) ; and• Coordinating suctioning and ventilation using an RTOS-based microcontroller for real-time task management and synchronization (205);Wherein the smart suction system can work standalone or can be integrated into ventilators to improve it’s functionalities.

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