Systems and methods for automatically removing fluid from multiple regions of a respiratory tract

Cross-reference to related applications This patent application is incorporated herein by reference in Indian Provisional Application No. 3988 / CHE/2014, filed August 14, 2014, entitled "DEVICE AND METHOD FOR REMOVAL OF SECRETIONS". It claims the priority of "TO PREVENT VENTILATOR ASSOCIATED PNEUMONIA".

Reference Citation All publications and patent applications mentioned herein are specifically and individually instructed that their respective publications or patent applications are incorporated herein. It is incorporated herein by reference in its entirety over the same scope.

The present disclosure generally relates to fluid management devices that include or are used with tracheal tubes and related devices. More specifically, the present disclosure relates to a fluid management system capable of removing secretions and monitoring obstruction from critical points along the endotracheal tube continuously or at predefined intervals. When an obstruction is detected, the system can subsequently remove the obstruction. The fluid and mucus can then be recovered for analysis. The device is a respiration insertion device that monitors and removes fluid in different areas along the tracheal tube.

The tracheal tube is inserted into the airway of a patient in a medical situation who is unable to breathe on his own due to impaired or lack of awareness / awareness on the part of the patient. Tracheal tubes help the patient mechanically ventilate until they can breathe on their own. Most tracheal tubes in use today have an inflatable cuff or balloon between the tracheal tube and the wall of the patient's trachea. A balloon or cuff blocks the airway passage and establishes a closed system, where the gas pressure on the patient's lungs can be more easily regulated, where the cuff or balloon is fluid and foreign matter in the patient's qi. Helps prevent it from entering the jurisdiction. Figures 1A-1B show typical respiratory tract sites where fluid can collect in the intubated patient's body. Figure 1A shows that major fluid retention typically occurs over the inflatable cuff of the tracheal tube, while Figure 1B also shows fluid retention in other areas along the trachea of the intubated patient. It shows that it is easily affected by.

The main complication associated with intubation and the use of tracheal tubes is pneumonia (VAP) associated with mechanical ventilation. VAP is a type of pulmonary infection that occurs in ventilated patients. VAPs typically affect already vulnerable patients, such as those in the intensive care unit (ICU) and / or those suffering from immunodeficiency. The onset of VAP can prolong the length of time a patient stays in the ICU and hospital. VAP also increases the probability of death by as much as 20-30%.

Generally, the tracheal tube allows the passage of bacteria through the lower part of the lungs of the intubated patient, resulting in VAP. These patients may already have the underlying problem of reducing resistance to bacteria. Bacteria can grow in the fluid that accumulates around the tracheal tube, especially if there is a bend in the tracheal tube where the fluid accumulates. Therefore, the first bend in the tracheal tube between the posterior side of the oral cavity and just past the pharynx, as well as the area above the inflatable cuff or balloon, may tend to retain fluid and mucus in particular. .. The risk of bacterial infection increases when the patient remains on the ventilator for extended periods of time. In addition, bacteria can be pulled down towards the lungs as they breathe. In addition, the bacteria responsible for VAP can be distinguished from the more common bacteria responsible for community-acquired pneumonia (CAP). Some bacteria associated with VAP are resistant to commonly used antibiotics. Therefore, it may be desirable to minimize the amount of fluid that collects along the tracheal tube, which can provide a comfortable medium for bacteria to grow.

Existing mechanisms for dealing with fluids that accumulate around the tracheal tube are not sufficient. In most of the systems currently available and described, the device may only be designed to draw fluid from the tracheal tube at one site, or there may be multiple suction sites along the tracheal tube. If there is a sex, the additional area is restricted to the area directly above the inflatable cuff or balloon. In some modifications, ports are located at two sites along the tracheal tube, but these sites are not associated with the patient's specific anatomical site. For example, US Pat. No. 8,434,488 ('488) describes a tracheal tube with multiple ports that are integrated with the main tracheal tube opening. The tracheal tube within '488 comprises only one suction lumen where suction is performed slightly distal to the cuff. The '488 tracheal tube also provides a conduit for inflating the cuff and maintaining a particular pressure within the cuff. Figures 1C and 1D show a conventional fluid management system in which suction occurs only in the area directly above the inflatable cuff. In addition, traditional fluid management systems require the caregiver to manually aspirate the fluid that is present throughout the time the patient is intubated, which is already understaffed medical care. It will require more time for the staff of the system.

Therefore, there is a need for fluid management devices for use in ventilation that can monitor fluid retention along different regions of respiratory (eg, tracheal) insertion and remove fluid automatically and periodically.

<p><patcit num="1"><text>U.S. Pat. No. 8,434,488</text></patcit></p>

<p> The present invention is a device (and automatically) for periodically (and automatically) removing fluid stored in three or more areas along a respiratory insertion device (eg, a tube) that is most likely to recover the fluid. (Including systems and devices) and methods. These devices may also be configured to flush the fluid conduit and / or perform patient irrigation.</p>

<p> Some areas (corresponding to the patient's anatomy) along the respiratory insertion device (intratracheal tubes, tracheostomy tubes, etc., which may be referred to herein as "tracheal tubes" for convenience) are tilted 30 degrees. Tends to collect fluid when inserted into the patient's body in a squeezed / horizontal position. The three identified areas include the lower glottis just above the inflatable balloon or cuff, the oropharyngeal cavity located through the oral cavity, and the oral cavity. The removal of accumulated fluid in these three areas significantly reduces the probability of developing VAP in intubated patients.</p><p> The fluid management device described herein can automatically remove fluid from multiple regions of the patient's respiratory tract. In some modifications, the fluid management device (eg, system) may be manually configured to remove fluid from different areas along the tracheal tube. Although described herein is a respiratory insertion device that can be attached to a fluid management system , the fluid management device described herein is an existing commercially available respiratory insertion device ( For example, it can also be configured to work with an endotracheal tube and a tracheostomy tube).</p><p> The fluid management system has inputs (eg, buttons, touch screens, dials, switches) that can receive user-selected control information such as wash delivery frequency, wash duration, wash pressure, suction application frequency, and suction pressure. , Etc.) can be provided. In some modifications, the user can set a pressure threshold to determine if there is an obstruction in the fluid conduit connected to the respiratory insertion device. The threshold value may be set in advance. For example, preset values may be set by the manufacturer. The threshold for pressure may be the same for each of the individual pipelines, but in some modifications, different pressure values for different pipelines may be selected.</p><p> The fluid management device described herein may also have other control and sensing components. It may include a suction valve that is in fluid communication with the sensor and suction mechanism. The valve can control the flow of fluid in the fluid conduit. These devices detect the presence of fluid in a particular pipeline and / or blockage in a fluid pipeline, or both, and even monitor when all fluid has been removed from a particular area. Flow and pressure sensors may also be provided. The system can also include filters before and / or after valves and sensors that are connected to or can be connected to one or more fluid pipelines. Filters can minimize contamination reaching valves and sensors.</p><p> The device described herein is capable of automatically removing fluid from multiple regions along the respiratory tract. The system can also be configured to clean the oral cavity of the respiratory tract. In some modifications, the system comprises one or more valves that are configured to be coupled to a controller circuit, display, and air pressure source. The system can also include first, second, and third fluid pipelines, which are coupled with one or more valves in the controller. The controller is configured to independently apply positive or negative pressure through each of the first, second, or third fluid conduits. The first fluid pipeline can be coupled to the first flow sensor and the first pressure sensor, and the second fluid pipeline can be coupled to the second flow sensor and the second pressure sensor. The third fluid conduit can be coupled to the third flow sensor and the third pressure sensor. The flow sensor can be outside each fluid line. In some modifications, there are four fluid conduits, including additional fluid conduits and also the three (oral, oropharyngeal, and subglottic) conduits mentioned above. Additional fluid tubes use a closed suction catheter or a modified respiratory insertion device with an additional lumen at the distal end facing inward (eg, qi). The secretions may be removed from the inside of the respiratory insertion device (eg, the tracheal tube) by removing the secretions from the inside of the intraluminal tube).</p><p> The controller circuit of the fluid management system periodically, automatically, and independently applies negative pressure to the first, second, and third fluid pipelines (and, in some modifications, the fourth, or When applied to an additional fluid line of the trachea, such as a fluid line), and the fluid flow rate in the first, second, or third fluid line becomes lower than the first flow threshold, and so on. It may be configured to stop applying negative pressure in the first, second, or third fluid conduit when the pressure in the fluid conduit rises above the first pressure threshold. The controller circuit also has a fluid flow rate that is lower than the first flow rate threshold when applying negative pressure, and the pressure is a second pressure threshold in the first, second, or third fluid conduit. Positive pressure can also be applied to the first, second, or third fluid conduits when they are lower than. Finally, the controller circuit is out of the flow rate of secretions in the fluid conduit, the thickness of the secretions in the fluid conduit, the volume of the secretions in the fluid conduit, or the color of the secretions in the fluid conduit. Data containing one or more of the above may be configured to be displayed for one or more of the first, second, and third fluid pipelines.</p><p> The fluid management system may also include a cleaning system (or subsystem). The lavage system (subsystem) applies positive pressure to deliver the lavage fluid through one of the fluid tubing (eg, the tubing connected to the area of the respiratory insertion device in the oral cavity) for irrigation. Negative pressure may be applied to one or more of the fluid lines to remove the fluid. The pump may communicate with the controller and the wash fluid source and can signal to send positive pressure into the fluid line. The system may include multiple fluid lines that connect directly to the wash liquid source (or may be connected via one or more separate wash delivery fluid lines). The controller can signal the wash pump to deliver the wash fluid by applying positive pressure to one or more wash delivery fluid lines. Any of these devices may also be equipped with one or more storage containers to hold the returning wash fluid.</p><p> Therefore, any of these systems can also include a wash fluid source (eg, an antibacterial mouthwash) and the controller automatically applies positive pressure to deliver the wash liquid at a wash delivery frequency. The first recovery vessel is coupled to the first fluid conduit to recover the fluid from the first fluid conduit, and the second recovery vessel collects the fluid from the second fluid conduit. It is coupled to a second fluid conduit to collect fluid from the third fluid conduit, and a third recovery vessel is coupled to a third fluid conduit to recover fluid from the third fluid conduit.</p><p> As mentioned above, these devices also include inputs configured to receive control information selected by the user, which may include (or be limited to) control information regarding suction and / or cleaning. This information can include wash delivery frequency, wash duration, wash pressure, suction application frequency, suction duration, and suction pressure.</p><p> In general, any of these devices can include one or more filters, with one or more valves communicating with the fluid line through one or more filters. The valve may be a suction valve, the first suction valve is between the first fluid line and the air pressure source, and the second suction valve is the second fluid line and the air pressure source. The third suction valve is between the third fluid conduit and the air pressure source.</p><p> As mentioned, the device can also include one or more wash delivery fluid lines connected to the wash liquid source, and the controller applies positive pressure to the wash delivery fluid lines. Is configured to deliver the wash fluid. The device may also include a pump that is configured to apply positive pressure, which communicates with the controller and cleaning fluid source. Therefore, the controller may apply positive pressure to deliver the wash fluid through the first fluid line and apply negative pressure to the first, second, and third fluid lines to remove the wash fluid. Can be configured. Finally, the device may be equipped with a container for recovering the used cleaning fluid.</p><p> The fluid management system described herein can also include the output of a display (eg, screen, monitor, etc.), the first, second, and in some modifications, third, fourth, Alternatively, data on additional fluid pipelines are shown. The data can include the flow rate of the secretion in the fluid conduit, the thickness of the secretion in the fluid conduit, the volume of the secretion in the fluid conduit, or the color of the secretion in the fluid conduit.</p><p> Any of these devices may include a collection container. One or more, for example, first, second, and third (and, in some modifications, fourth) recovery vessels are connected to the first, second, and third fluid conduits. Often, each is connected to one of one or more valves and an air pressure source.</p><p> The respiratory insertion device extends distally along its main axis. The respiratory insertion device comprises first and second lumens, the first and second lumens having first and second openings fluidly connected to the first and second lumens, respectively. To be equipped. The first and second openings are separated from each other along the tracheal tube so that the two regions along the tracheal tube, which tend to store fluid, correspond to the sites of the first and second openings. And arranged. In some cases, the first and second openings are at least 0.4 inches apart from each other. In another example, the third lumen with the corresponding third opening is within the region of the first and second lumens away from the site of the first and second openings. It is also arranged along the tracheal tube, which is not within the area corresponding to the site.</p><p> The first, second, and potentially third lumens all provide means for fluidly connecting to the corresponding fluid conduit at the opposite end from each opening. The fluid conduit is coupled to a suction device such as a pump that can pull the fluid away from the area associated with the first, second, and third openings. There may be separate fluid channels connecting to the first, second, and third lumens, or one fluid tube that serves to remove fluid from all existing lumens using the appropriate connector. There may be a road.</p><p> The fluid management system also includes sensors, one or more pumps, valves, and a controller that electrically communicates with other components. The controller inspects for fluid or mucus obstruction in different lumens corresponding to different areas of the tracheal tube. If obstruction is detected, the controller notifies the pump to apply positive pressure and then negative pressure to remove fluid and mucus.</p><p> In general, a tracheal tube is a catheter that is inserted into the trachea with the primary purpose of securing and maintaining the patient's airway and to ensure proper exchange of oxygen and carbon dioxide. Many different types of tracheal tubes are available and are suitable for different specific applications, including endotracheal tubes and tracheostomy tubes. For example, an endotracheal tube (ET) is typically a particular type of tracheal tube that is almost always inserted through the mouth (oral trachea) or nose (nasal trachea). A tracheostomy tube is another type of tracheal tube, which can be, for example, a 2-3 inch long curved metal or plastic tube to maintain a patency cavity (of tracheostomy). Can be inserted into a tracheostomy fistula (later). The respiratory (or, in some modifications, intrarespiratory) insertion devices described herein can be tracheal tubes or are used with tracheal tubes as described in more detail below. Can be adapted as</p><p> The system can be coupled to a respiratory insertion device (also referred to as the respiratory insertion body), the respiratory insertion device extending distally on the elongated axis, and the respiratory insertion device extending distally on the elongated axis. The lumen, and may have multiple openings, each lumen is fluidly connected to the openings, and the openings for different lumens are separated by at least 0.4 inches along an elongated axis. ing. Generally, each of the lumens in the plurality of lumens is configured to fluidly connect to one of the first, second, or third fluid conduits. As described in detail below, in some modifications, the systems described herein are fluids from additional fluid tracts and, in particular, from the center and / or main lumen of the tracheal tube. It may be equipped with a fourth fluid conduit that is configured to attach to the lumen within the tracheal device that may be connected to remove. This can be referred to as the tracheal duct.</p><p> As mentioned, the respiratory insertion device described herein can be a tracheal tube or can be connected to an existing tracheal tube. In the former case, the tracheal tube incorporates a fluid control feature and the respiratory insertion device has three or more (eg, four) integrated lumens along the main tracheal tube passage, eg, already. It may have three lumens for the sites mentioned and a fourth lumen for removing secretions from the inside of the main tracheal tube. As already mentioned, aspiration of the pre-determined area along the tracheal tube pathway is done through the opening along the respiratory insertion device. In the latter case, some examples are described herein when the respiratory insertion device is attached to an existing endotracheal tube. In one example, the respiratory insertion device can be clipped onto an existing endotracheal tube and can slide down along the length of the tracheal tube. The respiratory insertion device clip comprises a separate lumen with a corresponding opening that contacts a predetermined area along the tracheal tube. In some modifications of the respiratory insertion device, the clip may have a hinge to facilitate placement of the respiratory insertion device.</p><p> The respiratory insertion body can independently remove fluid from multiple regions of the respiratory tract. The respiratory insertion body may have an elongated axis extending from the proximal to the distal, and the first lumen is an elongated body having a first lumen proximal end and a first lumen distal end. Arranged along the section, the second lumen is located along the elongated body with the proximal end of the second lumen and the distal end of the second lumen, and the third lumen is the second. Arranged along an elongated body with three lumen proximal ends and a third lumen distal end. In some modifications, the device may include first, second, and third openings located on the distal ends of the first, second, and third lumens, respectively. The first, second, and third openings are at least 0. The first, second, and third openings are along the elongated axis. It can be positioned along an elongated body so that it is separated from each other by only 4 inches. The first opening in the respiratory insertion body may be configured to be positioned in the user's oral cavity and the second opening may be configured to be positioned in the user's mesopharyngeal region. The third opening that penetrates the intratracheal insertion body is configured to be positioned in the lower part of the user's gland when the intratracheal insertion body is inserted and passed through the user's throat. In some examples, the elongated body comprises a tubular body having a central tracheal tube lumen opening at the proximal and distal ends of the intratracheal insertion body. In another example, the elongated body comprises a sheath configured to connect on an endotracheal tube. The elongated body may be a spiral sheath configured to connect on an endotracheal tube. In some cases, a series of clips / attachments can be attached to cover the endotracheal tube. Generally, the first lumen proximal end, the second lumen proximal end, and the third lumen proximal end each include a fluid conduit coupler that is configured to attach to the fluid conduit. .. Finally, the first opening is between about 3 cm and 14 cm from the third opening, and the second opening is between about 2 cm and 10 cm from the third opening. ..</p><p> Some of the respiratory insertion devices described herein are for coupling to a tracheostomy tube or may incorporate a tracheostomy tube. In one example, the insertion device has a branched elongated body with a first arm and a second arm, the body having an elongated axis extending from proximal to distal. The first arm is configured to penetrate the lumen of the tracheal tube, extending outward from the distal end of the tracheostomy tube, wrapping around the distal end of the tracheal tube, and close to the top of the tracheal tube. It comprises a curved distal end region that is configured to extend to the position. The second arm is configured to extend distally along the outside of the tracheal tube. The first and second openings are disposed within the first arm of the elongated body. The first opening is located proximal to the curved distal end region of the first arm and is configured to be placed within the lumen of the tracheal tube. The second opening may be located distal to the curved distal end region and may be configured to be located outside the distal end region of the tracheal tube. The third opening may be disposed over the third lumen within the second arm, with the third opening located near the distal end of the second arm. The proximal end of the first lumen may include a first fluid conduit coupler that is configured to attach to the first fluid conduit, and the proximal end of the second lumen may be. It has a second fluid line coupler configured to attach to the second fluid line, and the proximal end of the third lumen is configured to attach to the third fluid line. It is equipped with a third fluid line coupler.</p><p> In another example, the respiratory insertion device comprises an integrated tracheostomy tube. Here, the insertion device comprises an elongated body having an elongated axis extending from the proximal to the distal, an inflatable cuff near the distal end of the elongated body, and a central lumen within the elongated body. Proximal to distal along an elongated body with a first opening facing inward towards the central lumen / passage (between the first lumen and the central lumen acting as a tracheal tube) Proximal to distal along an elongated body with a first lumen extending to and a second opening into a second lumen on the outside of the elongated body distal to the inflatable cuff. Proximal to distal along an elongated body with a second lumen extending into and a third opening into a third lumen on the outside of the elongated body located proximal to the expansion cuff. It may have a third lumen that extends to. As in the previous example, the proximal end of the first lumen may be provided with a first fluid line coupler configured to attach to the first fluid line, and the second inner. The proximal end of the lumen may include a second fluid conduit coupler that is configured to attach to a second fluid conduit, and the proximal end of the third lumen may be a third fluid. It may include a third fluid line coupler that is configured to be attached to the line.</p>

<figref num="1A">It is a figure which shows the conventional endotracheal tube (tracheal tube) inserted in a patient body where an arrow shows a pocket of fluid accumulation.</figref><figref num="1B">FIG. 5 shows tracheal and bronchial regions showing different regions where fluid can be recovered.</figref><figref num="1C">It is a figure which shows the conventional fluid withdrawal setup which only sucks the lower part of the glottis of a patient.</figref><figref num="1D">FIG. 5 shows a conventional endotracheal tube system that requires manual suction and subglottic secretions.</figref><figref num="2">FIG. 5 illustrates an example of a fluid management system with a respiratory insertion device that automatically, periodically monitors and removes fluid from multiple regions along the tracheal tube.</figref><figref num="3">FIG. 5 shows an example of a respiratory insertion device of an automated fluid extraction system through a subject's mouth (cross section is shown) and an opening formed in the patient's trachea.</figref><figref num="4">It is a figure which shows the general fluid management system as described in this specification.</figref><figref num="5">FIG. 5 illustrates an embodiment of a fluid management system that can be used in combination with various embodiments of a respiratory insertion device (three are shown on the right).</figref><figref num="6">FIG. 5 illustrates two aspects of a fluid management system with sensing and control components.</figref><figref num="7">It is a block diagram of an embodiment of a fluid management system showing a controller in relation to various components (tracheal tube, flow sensor, pressure sensor, pressure control mechanism, control valve, vacuum, cleaning, display, and power supply). Including).</figref><figref num="8">FIG. 3 is a block diagram of an alternative embodiment of a tracheal tube fluid management system for three regions of the trachea having an external suction section.</figref><figref num="9">FIG. 3 is a block diagram of an alternative embodiment of a tracheal tube fluid management system for three regions of the trachea having a built-in suction section.</figref><figref num="10">It is a circuit diagram of a modified form of a fluid management system.</figref><figref num="11">FIG. 6 is a block diagram of an embodiment of a fluid management system having a discharge collection vessel sensing unit and a pressure sensor, and having 6 independent pipelines including 3 pipelines for suction and 3 cleaning pipelines.</figref><figref num="12">FIG. 3 is a block diagram of another modification of a fluid management system with a check valve along each independent suction line.</figref><figref num="13">It is a figure which shows an alternative embodiment of the fluid management system which has a secretion recovery jar behind a suction valve and a control.</figref><figref num="14">It is a figure which shows an alternative embodiment of the fluid management system which uses a three-way valve and has one recovery jar behind a suction line, a valve, and a wash valve.</figref><figref num="15">FIG. 5 illustrates an alternative embodiment of a fluid management system having four independent pipelines with corresponding sensors.</figref><figref num="16A">It is a picture of a closed controller, a fluid pipeline, and a secretion collection tank.</figref><figref num="16B">It is an enlarged view of a controller which shows a microcontroller, a valve, a pump, and a circuit.</figref><figref num="16C">Yet another enlarged view showing a controller, a controller with a suction valve, a pressure controller, a vacuum, and a fluid pipeline.</figref><figref num="17">Another representative block diagram showing a fluid management system with three independent suction lines.</figref><figref num="18">FIG. 5 shows various combinations of conventional tracheal tubes and systems with disclosed fluid management systems and insertion bodies.</figref><figref num="19A">It is a figure which shows one modification form of the respiratory insertion device.</figref><figref num="19B">It is a figure which shows the spiral embodiment of the respiratory insertion device.</figref><figref num="19C-D">FIG. 19C shows a spiral breathing insertion device for use with a tracheal tube. FIG. 19D is an enlarged view of the area of the respiratory insertion device of FIG. 19A.</figref><figref num="20">It is a figure which shows the hinged embodiment of the breathing insertion device.</figref><figref num="21">It is a figure which shows the embodiment which resembles the stent of the respiratory insertion device.</figref><figref num="22A">It is a figure which shows the ring-shaped embodiment of the respiratory insertion device provided with a suction lumen.</figref><figref num="22B">FIG. 22A is an alternative perspective view of a ring-shaped embodiment of a respiratory insertion device with a suction lumen of FIG. 22A.</figref><figref num="22C">FIG. 5 is an enlarged view of a portion of a ring-shaped embodiment of a respiratory insertion device comprising a suction lumen.</figref><figref num="23A">FIG. 5 is a front view of an alternative embodiment of a clip breathing insertion device.</figref><figref num="23B">FIG. 23 is a side view of an alternative embodiment of the clip breathing insertion device of FIG. 23A.</figref><figref num="24A">FIG. 5 is an offset view of yet another embodiment of a clip breathing insertion device comprising two materials.</figref><figref num="24B">FIG. 5 is a side view of another embodiment of a clip breathing insertion device with a C-shaped support.</figref><figref num="25A">FIG. 5 is a front perspective view showing an embodiment of a respiratory insertion device having five channels for irrigation and secretion removal.</figref><figref num="25B">FIG. 5 is a side view showing an embodiment of a respiratory insertion device having five channels for irrigation and secretion removal.</figref><figref num="25C">FIG. 5 is a perspective view illustrating an embodiment of a respiratory insertion device having five channels for irrigation and secretion removal.</figref><figref num="26A">FIG. 5 is a frontal and perspective view of an embodiment of a clip breathing insertion device having a laminated lumen.</figref><figref num="26B">FIG. 26A is a side view of the free clip breathing insertion device of FIG. 26A having a laminated lumen.</figref><figref num="26C">FIG. 5 is a side view of a clip breathing insertion device having a laminated lumen engaged with a tracheal tube.</figref><figref num="27A">It is a side view of the oropharyngeal airway insertion main body part.</figref><figref num="27B">It is another figure of the oropharyngeal airway insertion body part.</figref><figref num="27C">FIG. 3 is a third view of an oropharyngeal airway insertion body showing a suction port.</figref><figref num="27D">It is a side view passing through the proximal end of the insertion body part of FIG. 27A.</figref><figref num="28A">It is a side view of the integrated respiratory insertion device which shows the 1st suction area.</figref><figref num="28B-C">FIG. 28B is a side view of the integrated respiratory insertion device of FIG. 28A showing a second suction region. FIG. 28C is a side view of the integrated respiratory insertion device of FIG. 28A showing a third suction region.</figref><figref num="28D">FIG. 28A is a cross-sectional view through the proximal end of the integrated respiratory insertion device of FIG. 28A.</figref><figref num="28E">FIG. 28A shows the distal end of the integrated respiratory insertion device.</figref><figref num="28F">It is another figure of the breathing insertion body part which has three ports along the main body part.</figref><figref num="28G">It is sectional drawing which shows the respiratory insertion main body part of FIGS. 28A-28F which shows the internal port for sucking the inside of an endotracheal tube.</figref><figref num="29A">FIG. 5 is a drawing of a first embodiment of a respiratory insertion device for use with a tracheostomy tube.</figref><figref num="29B">FIG. 9 shows a respiratory insertion device of FIG. 29A engaged with a tracheostomy tube.</figref><figref num="30">It is a figure which shows an example of the integrated respiratory insertion device including a tracheostomy tube.</figref>

Described herein are systems and devices for managing the recovery of unwanted fluid along the tracheal tube. In general, a fluid management system may include a controller, multiple fluid lines, multiple flow rate sensors, multiple pressure sensors, a cleaning subsystem, and at least one secretion recovery jar. In some embodiments, the fluid management system can also accommodate a display that indicates the pressure value or keeps the user informed that the system is operating within a cycle. The system may also be adapted to display the results of analysis of secretions. The respiratory insertion device can be coupled to any of the fluid management systems described. The respiratory insertion device described below may generally function to remove fluid that has accumulated along several areas of the tracheal tube. The respiratory insertion device may be used in conjunction with an existing tracheal tube or may perform the function of a tracheal tube, including a tracheostomy tube, in addition to serving to manage fluid recovery along the respiratory tract. In general, the system can include controllers, power supplies, pumps, valves, suction devices, sensors, fluid lines, displays, and switches.

The system described herein can automatically remove fluid from multiple regions along the respiratory tract. The phrase "automatically" may refer to an activity or function that can operate independently (eg, without continuous input from the user). In some variations, the phrase "automatically" can indicate that certain actions are performed without manual intervention. This does not mean that no manual intervention is required, but in the current case it is used by human intervention to trigger or set up a process that can be automatic in all other respects. Because it can be done. In particular, the user can configure the system to operate at defined intervals or when some conditions are met.

A fluid may refer to a substance that flows under the applied shear stress and is capable of continuous deformation. Fluids can include liquids, gases, plasma, and certain solids. Where applicable, the term fluid can be used herein as a synonym for a liquid, which is a substance that has a well-defined volume but does not have a fixed shape. Therefore, the fluid may refer to biological fluids secreted from the human oral cavity and respiratory system, primarily saliva, mucus, stomach contents, and lavage fluids.

The system may then include a fluid conduit that connects the respiratory insertion device to the fluid management system. The fluid conduit may be a hollow body that can carry a fluid, liquid, or gas from one site to another (eg, piping, flow path, etc.). Fluid lines can be formed from metals, glass, rubber, and other synthetic or natural materials. The fluid conduit can be formed from a fluid impervious, hollow, cylindrical body that connects the respiratory insertion body to the fluid management system.

The respiratory tract may refer to areas related to the respiration of mammals, especially humans. In general, "breathing tract" may refer to the upper and / or lower respiratory tract. The upper respiratory tract may refer to a portion of the respiratory system above the glottis (vocal cords), while the lower respiratory tract consists of the trachea, bronchioles, bronchioles, and lungs. The respiratory tract may refer to the oral cavity, glottis, trachea, and the area directly above the bronchi.

As explained above, the tracheal tube refers to a hollow tube that can be inserted into the patient's trachea solely to secure and maintain the patient's airway and to ensure proper breathing. Good. In general, tracheal tubes can include endotracheal tubes and tracheostomy tubes.

A controller may generally refer to a device that can interface with peripheral components and control how the peripheral components interact and operate with each other. The controller can include circuits (eg, chips, chipsets, cards, and the like) for sending commands to components that are present with the fluid management device. The controller may contain logic gates, routines / subroutines, and data storage components for executing monitoring and suction programs. The controller may also include external user interfaces such as displays, buttons, and switches.

A sensor generally refers to a component that can detect certain characteristics of the environment in which it is placed. In particular, described herein are flow rate sensors and pressure sensors. The flow sensor may be configured to detect the presence or absence of fluid. Flow sensors can be pressure differential flow meters, velocity flow meters, positive displacement flow meters, mass flow meters, or open channel flow meters, IR-based sensors, capacitance sensors, and UV sensors. The pressure sensor detects pressure and may include, but is not limited to, an absolute pressure sensor, a gauge pressure sensor, a vacuum pressure sensor, a pressure difference sensor, and a sealed pressure sensor. Some pressure sensors are force sensors that collect force values to measure strain when pressure is applied to the area, piezoelectric resistance strain gauges, capacitance, electromagnetics, piezoelectricity, light, and Includes potential difference measurement. Other force-collecting pressure sensors may include resonant, thermal, and ionized pressure sensors. Whatever the type of sensor, calibration is useful in accurately determining the values associated with the detected condition. Finally, the flow and pressure sensors can be inside or outside the fluid management system. One possible location is where the flow and pressure sensors are placed on the fluid conduit of the system, which is relatively close to the site where the system connects to the respiratory insertion device. Other potential parts for the flow and pressure sensors may be within the controller unit body.

Washing may refer to removing unwanted material or rinsing the body cavity with water or a solution containing a drug for diagnostic purposes. As described herein, lavage can be performed in various pre-determined areas along the respiratory insertion device. For example, the devices described herein can perform irrigation of the patient's oral and oropharyngeal areas.

<u style="single">Fluid management system</u> In general, a fluid management system may include fluid lines, sensors, controllers and circuits for controllers, and cleaning components. The controller is typically part of a fluid management system that monitors the operation of fluid management system components. The controller delivers the fluid if it draws and removes the fluid from the area along the tracheal tube, or if it cleans a specific area of the oral cavity or respiratory tract where the tracheal tube is inserted. Circuits and microcontrols for adjustment can be included. The controller may include a valve that connects and maintains the fluid conduit that connects the respiratory insertion device to the sensing, suction, and pumping components of the fluid management system. In use, the controller may also include microcontrols that include circuits for adjusting sensing, suction, and pump operating cycles. The controller applies pressure, suction, or sensing to each fluid line on a regular, automatic, and independent basis.

The fluid management system also includes a fluid conduit that connects the respiratory insertion device with the sensing, pumping, and suction components of the fluid management system. The fluid pipeline may be arranged and configured in a plurality of configurations. In some examples, separate fluid conduits connect to each of the ports contained on the respiratory insertion device. In another example, multiple ports on the respiratory insertion device may be connected to a single fluid conduit via a multiport component. Fluid lines such as surgical pipes, pressure pipes, or the like should be flexible. Although no priorities are stated herein regarding the material of the fluid line, the fluid line can withstand suction without crushing the walls of the pipe or pressure without causing line breakage from the applied pressure. It is beneficial to be able to withstand.

A fluid management system typically determines the presence (eg, by flow rate) of secretions (presumably taken from a pre-determined region along the tracheal tube) in the fluid pathway. And also includes a sensor that allows the amount of pressure or suction applied to be adjusted. The flow and suction sensors may be present to detect the presence or absence of secretions that flow and pass through the sensor. The sensor may be configured to send an analog / digital signal to the controller. The fluid management system can then compare the sensed signal to a pre-programmed value entered by the user or manufacturer and keep the system running until it senses the presence of secretions.

The controller may incorporate a power supply that drives the components of the fluid management system. If the power supply is integrated within the body of the controller, the buttons and switches may be located on the body of the fluid management system, which allows the user to control the fluid management system. In another example, the power supply is maintained externally and connected to the fluid management system when in use. Fluid management systems may also include pumping and suction mechanisms that are maintained internally or externally.

The fluid management system may then be equipped with a cleaning mechanism for rinsing the empty area associated with the tracheal tube. Area irrigation is in contact with the tracheal tube and fluid or water vapor can help reduce the amount of harmful microorganisms that can accumulate. Cleaning the patient's oral cavity is most common, but cleaning of other areas along the tracheal tube, such as the oropharyngeal region or the lower glottis, is also possible. The fluid management system includes a fluid conduit that connects to a respiratory insertion device to deliver wash fluid from an empty area and then aspirate. The cleaning fluid may be sterile water, saline solution, chlorhexidine, or other suitable solution.

The fluid management system may also include analytical components that can inspect fluid drawn from different areas along the patient's tracheal tube. A fluid management system may include pre-programmed subroutines that can periodically inspect the extracted fluid for several types of harmful microorganisms. If detected, the fluid management system informs the doctor or caregiver of the potential for infection based on a positive test for harmful microorganisms, or the viscosity, volume, and / or of the extracted fluid. A means of analyzing color may be provided.

The fluid management system may also include one or more secretion collection containers (eg, jars, chambers, cups, etc.). Secretory recovery jars can be placed at different sites with respect to other components of the fluid management system, as described in more detail below. In addition, there may be a single secretion recovery jar that recovers all fluid from different regions along the respiratory insertion device, or another separate fluid recovery jar that corresponds to fluid recovery from different regions. obtain. There may also be a separate fluid recovery jar to receive the wash fluid. The resulting fluid can be discarded or sampled to check for the presence of microorganisms. In some examples, the recovery jar also features a fluid level sensor to detect when the liquid reaches a certain level, alerting the user to empty one or more recovery jars. Can be done.

Upon use, the system initiates sample aspiration for a predefined period of time (this is adjustable and can be set by the physician based on the patient's clinical judgment and condition). During sample suction, the control unit turns on the suction valve and suction begins during the minimum set time (preset by the doctor or manufacturer). During this sample aspiration step, secretory fluid (saliva, mucus, gastric juice reflux, or other body fluid) is sucked up to a sensing unit near the patient's head. The sensing unit senses the presence of flow / fluid and keeps suction on until it senses that the presence of flow / fluid / secretion has decreased to a preset value. This fluid is recovered in a recovery jar.

When there is no longer fluid / secretion in the patient's oral cavity / mesopharyngeal / subglottic (above the cuff) and / or inside the main lumen of the tracheal tube, the sensor unit has secretions in the piping. It is good to detect that it is not, and it is checked for port blockage by using a pressure sensor. After the port blockage is detected, the cleaning liquid from the liquid container is pumped into the blocked pipeline by opening the valve using a pump. This fluid, injected in the direction opposite to the direction of suction, clears the obstruction of the port. The injected fluid is immediately aspirated by using suction from the other two lines or by the same line.

If none of the ports are blocked, the pressure sensor will not detect the port blockage and the system will conclude that there are no more secretions. It is then turned off until the next cycle of sample suction.

The sheath / sleeve has an additional port, or by using the intraoral port, the lavage fluid is passed through the oral cavity at regular intervals preset by the physician (or manufacturer in some embodiments). Perform oral rinsing and maintain oral hygiene. The cleaning liquid is immediately sucked out by the same port / other port. The device effectively reduces contact between the nurse / caregiver and the patient's trachea, thereby reducing the likelihood of cross-infection.

The device calculates and analyzes the volume, flow rate, and viscosity of the secretion, plots a graph of the patient's secretion pattern, and detects and predicts the onset of infection, or detects the initial symptoms of infection. Incorporates software. It is also possible to detect a pathogen if the device has the additional feature of detecting a particular strain of the bacterium / pathogen responsible for the infection by using microfluidic based technology.

The device can share data through USB, Internet, WiFi, Bluetooth®, Ethernet®, Memory Stick, or other data transfer technology to print out a hard copy of the patient's infection graph. Has a small printer attachment.

With reference to FIGS. 2 and 4, general embodiments of the fluid management system 200 and the respiratory insertion device 270 are illustrated. In this particular example, there are three fluid lines 220 that connect to the respiratory insertion device 270. Various embodiments of the respiratory insertion device and how it connects to a fluid management system and even to an existing tracheal tube are described in more detail below. The fluid management system shown in this example has an integrated controller 201 with a flow sensor 230 and a pressure sensor 240 (not shown). Also included, but not shown herein, are the pressure control 242 and the suction / vacuum motion control 232 for detecting and removing fluid pools in the preset area along the tracheal tube. is there. Also illustrated is a single secretion recovery jar 260. As already mentioned, the fluid management system can collect the fluid drawn from the preset area along the tracheal tube separately, but the user can collect the fluid through the separate fluid lines 220. It can be easily combined into one fluid recovery jar 260. FIG. 3 better shows the respiratory insertion device 370 in the body of an intubated patient with an existing tracheal tube. This picture shows a cross section of the patient's oral cavity, oropharynx, and lower glottis with a tracheal tube and area along the patient's respiratory tract corresponding to fluid retention, and the respiratory insertion body monitors fluid. Can be removed.

Figure 4 shows a general schematic of the fluid management system 400 and its key components. The placement and connection between the components shown is exemplary and is intended to show the reader a general placement of these components. The components are arranged, configured and combined by various means suitable for managing the fluid stored in the intubated patient, which will be described in more detail below.

Finally, any fluid management system can incorporate irrigation as a complement to the task of removing fluid secretions around the tracheal tube. The lavage can be applied to the patient's oral cavity, oropharynx, or lower glottis to hydrate areas that are normally soaked in saliva but cannot be done in the case of unconsciously intubated patients. Washing can be used to regularly wash away the aforementioned areas to remove foreign bodies and microorganisms that can cause infection. Fluids for irrigation and suction channels may be in addition to those already present to sense and remove fluids from the oral cavity, oropharynx, and lower glottis, either inside or outside the controller. Has separate pumping and suction components. In some cases, the wash line can enter and share the existing fluid line.

Figures 5 and 6 show fluid management system units as they are currently conceived and put into practical use. In FIG. 5, a representative number of respiratory insertion devices are illustrated, indicating that the fluid management system can be used with any of the respiratory insertion devices described below. The overall goal of a fluid management system is to sense and control the amount of fluid secretions from intubated patients who collect along the tracheal tube.

The sensing aspect of the fluid management system may include two types of sensors. The flow sensor can be used to determine the flow rate at a particular moment in the tube, while the pressure sensor is used to determine the port blockage after the flow rate sensor detects the absence of secretions. Can be done. At the same time, the pressure sensor can record the pressure value associated with any of the fluid lines connected to the respiratory insertion device and send the value back to the controller for reporting. Routines in the controller have preset values of detected pressure so that occlusion or fluid recovery is indicated in a specific area along the respiratory insertion device when the detected pressure is less than the preset value. Can be started to compare with. The sensor can be placed in any suitable area, including the port opening of the respiratory insertion device, or sites along the fluid pathway, to detect the presence of fluid in these sites. As mentioned, the sensor may be of a non-contact type, eg, configured to be located outside the fluid conduit, and thus does not come into contact with the fluid in the fluid conduit. If the fluid flow rate (and thus the fluid) is detected, sent back to the controller and reported, the controller can initiate a set of instructions to remove the fluid. In this configuration, the pressure sensor can detect obstruction only when the flow sensor first detects the absence of secretions.

The control aspect of the fluid management system regulates the mechanical and pressure flow within the system. As shown in FIG. 6, a solenoid valve connected to at least one pump is used to control the flow of fluid in the fluid management system and respiratory insertion device. Also held within the fluid management system module is an electronic device for collecting and holding information related to the frequency of monitoring for blockages. There may also be internal tests to detect the presence of potentially harmful microorganisms in the fluid pipeline. Information about the status of the fluid management system can be displayed on an integrated monitor or on another monitor.

A first embodiment of a fluid management system is shown in FIG. Controller 701 links all other existing components. The respiratory insertion device 770 may be an integrated tracheal tube, sheath, or one of the other arrangements described below. The respiratory insertion device can be configured as a primary tracheal tube or an attachment to an existing tracheal tube within the patient's body. The respiratory insertion device 770 may include at least two lumens for aspirating two different areas along the tracheal tube. The respiratory insertion device 770 is fluidly connected to the remaining components of the fluid management system 700 via the fluid conduit 720. Adjacent to the respiratory insertion device 770 is the flow sensor 730. The flow sensor detects the flow / presence of secretions at a particular site at a given moment and assists in switching off the device when it senses the absence of secretions. This cycle starts at predetermined time intervals and continues to operate until there is no more flow. A flow sensor 730 is associated with each conduit present within the respiratory insertion device 770. The flow sensor 730 can detect if fluid is still present in the corresponding conduit within the respiratory insertion device 770. The flow sensor 730 can automatically and continuously (within a given cycle) detect the flow in the corresponding pipeline as part of a step-by-step routine. Alternatively, the user can manually determine the flow rate in any or all of the pipelines by selecting some options provided within the controller 701. In embodiments of the invention, the flow sensor 730 is shown to match other components of the fluid management system 700, but in other examples the flow sensor is with another lumen within the respiratory insertion device. Can be associated. The flow sensor is any suitable sensor capable of detecting the flow and / or presence of secretions in the pipeline and sending back the report. Good. Examples of such sensors may include IR sensors, UV sensors, resistance sensors, capacitance sensors, ultrasonic sensors, and Hall effect sensors.

In the embodiment subsequently shown in FIG. 7, the fluid management system 700 also includes a pressure sensor 740 and a pressure control 742. The pressure sensor 740 can detect the pressure in the corresponding fluid conduit that connects to a particular lumen of the respiratory insertion device 770. Controller 701 may include routines that automatically and periodically inspect the pressure in the fluid conduit or manually at the request of the user. The pressure control 742 can generate negative pressure in the pipeline to assess the amount of blockage in a particular pipeline, or generate positive pressure to help clear the blockage in a particular pipeline. it can. There may also be a pressure relief / release section 747 in the fluid management system where the perceived pressure in the pipeline is higher than the set threshold. Having the pressure relief / release 747 can prevent excessive pressure from being applied to the patient's respiratory tract or into the fluid connection of either the respiratory insertion device or the fluid management system.

The embodiment shown in FIG. 7 also comprises a recovery jar 760. Although the block diagram does not show the possible number of recovery jars, there may be one central recovery section where all of the extracted fluid is retained or which can be multiple recovery jars. If there is only one recovery jar, the corresponding multiport valve is used to connect the fluid pipeline to the recovery jar. Multiple recovery jar setups are more useful in locating the source of infection and provide a clearer idea of what areas along the patient's respiratory tract are targeted for treatment in the event of an infection. Bring to people. It also uses that when the fluid in the jar reaches a certain level, the fluid level sensor sounds an alarm to signal the controller and one or all of the recovery jars need to be emptied. It may also be beneficial to have a volume sensor in all of the existing recovery jars to notify the person.

The cleaning system 750 is also present in the embodiment shown in FIG. The cleaning system 750 includes a cleaning pump 751 and a cleaning pressure control valve 752. Although not specifically indicated herein, the rinsing system 750 may deliver the rinse fluid to at least one region along the respiratory insertion device 770. Controller 701 adjusts the wash pump 751 and the wash pressure control valve 752 to deliver the rinse fluid to one or more regions of interest at the desired flow rate and pressure. When the rinse portion of the wash cycle is complete, the wash pump 751 can apply negative pressure to aspirate and remove the rinse fluid. Although not specifically shown, an additional fluid conduit connected to the recovery jar can receive the fluid after rinsing. Alternatively, additional fluid pipelines can be connected to any of the fluid recovery jars already present in the fluid management system. 8 and 9 show two possible arrangements of suction features in the fluid management system embodiments described earlier. In FIG. 8, the suction feature is not included in the fluid management system 800. In this arrangement configuration, a suction or vacuum operation feature is provided externally. Figure 9 shows the case where a suction / vacuum function is provided in the fluid management system. Both arrangements have both advantages and disadvantages, but neither has a significant impact on the overall functioning of the fluid management system. Finally, in both of the modifications shown, the recovery jar is placed after the suction and pressure valves. The advantage of having a suction and pressure valve closer to the respiratory insertion device is more precise control of suction and pressure within the respiratory insertion device. The disadvantage of placing the pressure and suction valves between the respiratory insertion device and the recovery jar is that during suction they can be more easily contaminated by the fluid passing through them. Having a recovery jar between the respiratory insertion device and the pressure and suction valve minimizes valve contamination, but also at the distal end of the respiratory insertion device.

FIG. 10 shows a more detailed diagram of an embodiment of a fluid management system. The system of FIG. 10 is similar to that shown in FIGS. 7-9, but the figure of FIG. 10 shows a concept beyond the generality of the fluid management system and puts the fluid management system into practical use. The components used for this are disclosed in more detail.

11 to 15 show further modifications of the arrangement of recovery jars and various valves present in the fluid management system. In the fluid management system 1100 shown in FIG. 11, the recovery jar is placed in front of the suction and pressure valves. In system 1100, three separate conduits emerge from the respiratory insertion device 1170. A recovery jar 1160 is associated with each pipeline 1120. The recovery jar 1160 may be a single jar or multiple jars, eg, a recovery jar corresponding to each pipeline. As already mentioned, one of the major advantages of having a recovery jar in front of at least some of the valves is that less contaminants reach those valves during suction and cleaning or replacement of these valves is less frequent. The point is that it does not have to be done. There are also sensing units 1130, 1140 that sense pressure and flow and are associated with each fluid pipeline. In many of these embodiments, filters are placed in front of the various modules, thereby minimizing contamination of these modules. The system 1100 also includes a lavage unit 1150 with three separate lavage lines 1153 connected to a respiratory insertion device (not shown). The three wash lines 1153 are controlled by a central wash control valve 1152 and a wash pump 1151. Also provided is a wash jar 1158 containing the wash liquid, which is pumped through each of the wash lines 1153, thereby rinsing different areas along the respiratory insertion device. Can be done. The wash control valve can allow the wash liquid to enter only one or two of the wash lines 1153 for rinsing. Control of which wash line receives the rinse fluid may be controlled by the operator or may be based on detection values or conditions set by the controller that automatically signals the wash system to operate thereafter. Although not shown, the cleaning system 1150 may be provided with a separate conduit for removing cleaning liquid after cleaning is complete, or used cleaning.

FIG. 12 shows an alternative embodiment of a fluid management system setup. Similar to the system 1100 setup, the system 1200 has recovery jars 1260, which are placed in front of the suction valve 1245. One notable difference in the System 1200 is that the contents in the wash line 1253 flow into the fluid line 1220 and do not enter the respiratory insertion device directly. As shown, each wash line 1253 enters the corresponding fluid line 1220. To prevent the wash fluid 1259 from moving towards the suction valve 1245 rather than towards the breathing insertion device during wash, the system 1200 includes a series of check valves 1248. When on, the check valve 1248 pushes the wash fluid towards the respiratory insertion device. For example, the check valve may have an on / off function and can be operated to close the suction line only after the cleaning liquid creates pressure, at other times the suction line is It remains open.

FIG. 13 shows yet another embodiment of the fluid management system setup. Similar to System 1200, System 1300 Wash 1350 is routed to the corresponding fluid line 1320 before reaching the tracheal tube attached to the patient. In system 1300, the recovery jar 1360 is placed behind the suction valve 1345 and the pressure valve 1344 is placed between the recovery jar 1360 and the respiratory insertion device. As already mentioned, one of the disadvantages of bringing the fluid line 1320 into contact with the suction valve 1345 and the pressure valve 1344 is the increased probability of contamination. To minimize this effect, the valves are made to have non-clogging components that allow fluids of different densities and viscosities to pass through. In some examples, the interior of the valve may be coated with a non-adhesive material to make it difficult for microorganisms to adhere. The valve may be a non-contact valve (eg, a pinch valve) and is therefore contaminated as the valve body never contacts the fluid and the valve only pinches the fluid line 720 to shut off. Can solve the problem.

FIG. 14 shows the final fluid management system configuration with three fluid pipelines. In System 1400, the jar 1460 is located near the suction source and far away from the suction valve 1445 and the respiratory insertion device. Suction valve 1445 is a three-way valve that allows different functions of the fluid management system to share some of the same pipelines that can reduce the space required within the fluid management system. System 1400 includes a wash line (not shown in FIG. 14) that connects to the rest of the fluid line 1420 of the fluid management component between the suction valve 1445 and the jar 1460. System 1400 also includes sensor units 1430 and 1440 for monitoring pressure and flow. The system 1400 also includes an additional suction control valve 1457 that can control the removal and flow rate of used wash fluid 1459 from the patient's respiratory insertion device.

FIG. 15 shows an embodiment of a fluid management system having four independent fluid pipelines. The rest of the fluid management system remains the same. In this embodiment, an extra fluid conduit can be used to remove fluid from a fourth site along the tracheal tube. Additional fluid channels can also be used to remove fluid from the actual tracheal tube.

Figures 16A to 16C show diagrams of the setup of a fluid management system to be put into practical use. Figure 16A shows a controller connected to various fluid pipelines. 16B and 16C are enlarged views of a controller with valves, pumps, motors, and microcontrols.

<u style="single">Respiratory insertion device</u> As mentioned, the fluid management system described above can be coupled to a respiratory insertion device. 17-30 illustrate different embodiments of the breathing insertion device connected to the fluid management system and even the intended breathing insertion device.

In some modifications, the respiratory insertion device snaps onto the endotracheal tube and can slide down to the appropriate position. For example, the sheath / sleeve can be placed in the oral cavity of an intubated patient whose dorsal end reaches the vocal cords. Sheaths / sleeves run in two or more (eg, three) parallel independent channels with multiple openings / ports in the lower glottis, oropharyngeal region, and different sites corresponding to the oral cavity. May be. In some modifications, the sheath is a lumen (and / or when the connected tracheal tube already has a lumen that can be used to remove fluid from the area around the tracheal tube (and / or within the tracheal tube). It has only two channels). The ends of these channels have connectors for connecting to the piping of the suction pipeline.

The respiratory insertion device can be made from any suitable material. Such materials are, but are not limited to, polyurethane, polyvinyl chloride (PVC), polyethylene terephthalate (PETP), low density polyethylene (LDPE), polypropylene, silicone, neoprene, polytetrafluoroethylene (PTFE), or polyisoprene. Or other related elastomers, plastics, or rubbers or any other biocompatible material.

The respiratory insertion device may be connected to a connecting pipe and the sensing unit may be placed for optimal sensing. The sensing unit houses a fluid detection sensor and its value is controlled by a microcontroller and a set of valves, namely a suction on / off valve, a cleaning on / off valve, a suction pressure control valve, a cleaning pressure control valve. And send to the processing unit. It also houses a variable power pump, recovery jar, and display. The recovery jar is equipped with, but not limited to, equipment for mounting a sample recovery system with a small jar, which collects a small amount of secretions sent to the Bacteriology / Pathology Institute.

The control and processing unit is driven by an external or internal power source. Suction is performed from an external negative pressure source such as a suction generator (wall-mounted suction pipeline, portable suction system, independent suction system), which is connected to the control unit.

Figure 17 shows a global tracheal management system with fluid management system 1700 and respiratory insertion device 1770. Generally, the respiratory insertion device 1770 comprises a sheath 1773 having a proximal end 1771 and a distal end 1772. The proximal end 1771 is located adjacent to the fluid management system 1700. The distal end 1772 corresponds to the intubated patient's lower glottis. The respiratory insertion device 1770 generally comprises at least two lumens, typically a third lumen. In Figure 17, three lumens 1774, 1776, and 1775 are shown. Proximal and distal ends of the lumens 1774, 1776, and 1775, respectively, extend longitudinally along the length of the sheath 1773. Each of the proximal ends of lumens 1774, 1776, and 1775 can be coupled to the corresponding fluid conduit (not shown) of the fluid management system 1600. The distal ends of lumens 1774, 1776, and 1775 correspond to different regions along the tracheal tube. Of particular note is the oral cavity, oropharynx, and lower glottis of the intubated patient. The distal ends of the lumens 1774, 1776, and 1775 are provided with oral suction ports 1777, 1778, and 1779 to detect and draw fluid from these areas that are in direct contact with the ports, respectively. Further shown in FIG. 17 are the flow sensor 1730 and the liquid / pressure sensor 1740. The flow sensor 1730 can detect the flow rate of the fluid in the fluid pipeline and assist in adjusting the flow in the fluid pipeline. The pressure sensor 1740 detects the amount of resistance when negative pressure is applied through the fluid conduit and relays to the controller if the amount of resistance is greater than the threshold, indicating that there is a blockage in the conduit. be able to. Although the pressure sensor 1740 shown in FIG. 17 is located in the lumens 1774, 1776, and 1775, the pressure sensor can be placed on the fluid conduit and outside the respiratory insertion device.

Different combinations of respiratory insertion devices can be combined with the various configurations of the fluid management system described above. Figure 18 shows a subset of possible combinations of respiratory insertion devices and fluid management systems. First of all, the fluid management system can be used with conventional tracheal tubes, more specifically with endotracheal tubes or tracheostomy tubes. This is less than ideal as conventional tracheal tubes do not have the necessary lumens and corresponding ports that allow fluid monitoring and drainage. Figure 18 also shows that fluid management systems can be used with modified tracheal tubes that have lumens that attach to existing tracheal tubes. Figure 18 also shows a subglottic secretion (CASS) tube that allows for suction along the lower glottis and also for use with an innovative integrated tracheal tube configuration described in more detail in the next paragraph. It also shows continuous suction of. And finally, the figure shows that the fluid management system can also work with an integrated endotracheal tube whose lumen is integrated into the device body.

19A-19D show a first embodiment of the respiratory insertion device 1970. The respiratory insertion device 1970 has a proximal end 1971 near the infused patient's mouth, and a distal end 1972 corresponding to the end of the patient's trachea and the apex of the bronchial region. The respiratory insertion device 1970 has a spiral configuration in which the device body 1973 wraps around the existing tracheal tube 1990. The device 1970 was pushed to prevent the distal end of the device 1970 from passing through the safe area of the patient's respiratory tube after contacting the cuff 1991 of the tracheal tube and along the existing tracheal tube. Proper positioning of the device 1970 is achieved when the distal end of the device 1970 abuts the cuff 1991 and the proximal end of the device 1970 is adjacent to the proximal end of the existing tracheal tube. The device 1970 comprises at least one device fluid conduit 1980 for suction. The device fluid line 1980 may include a coupler 1981 for mounting on the fluid line of a fluid management system. A small circle along the tracheal tube indicates the case where fluid is most likely to accumulate. As shown in the previous literature, one area of fluid retention corresponds specifically to the patient's lower glottis around the cuff. Two other areas not specifically mentioned that are targeted by the previous tracheal tube fluid management device are the oral cavity and the oropharyngeal area adjacent to the tracheal tube. Unconscious intubated patients, especially in the presence of tracheal tubes, cannot tell that saliva has accumulated in the mouth and that there is no automatic regurgitation to remove fluid from their mouth. The oropharyngeal region is also prone to fluid retention when combined with the typical horizontal position of an intubated patient due to the arched bend in the tracheal tube as it passes through the oral cavity and enters the trachea. FIG. 19A shows a respiratory insertion device similar to FIG. 17, and FIGS. 19B, 19C, and 19D show enlarged views of a portion of this device. Suction ports are arranged in various areas on the device body 1973. Tracheal chew The blow-up diagram corresponding to the oropharyngeal region along the bu shows multiple ports 1978. Circles and arrows indicate that fluids and other debris move towards port 1978 and are aspirated and removed. Although not specifically shown, the port is also located on the respiratory insertion device body corresponding to the intubated patient's oral cavity and lower glottis. Also, the spacing between the ports corresponding to the different regions of the tracheal tube should be at least 0.4 inches from each other (eg, the ports at the distal end of the lumen). At the proximal end of the lumen, which may connect to the fluid conduit, the ports into the lumen may be directly adjacent to each other or may extend as tubes from the device. This requirement does not apply to ports associated with the same area, which is shown in the enlarged views of Figures 19B, 19C, and 19D.

FIG. 20 illustrates an embodiment of a respiratory insertion device 2070 for removing fluid from two or more areas along a tracheal tube according to some embodiments. Device 2070 comprises a sheath 2073. Sheath 2073 has a hinge 2084 and an opening 2085. Arranged along the perimeter of the sheath 2073 are multiple lumens. In Figure 20, two lumens 2074 and 2075 are shown. Lumens 2074 and 2075 of the existing tracheal tube 2 through a port (not shown) located adjacent to the distal end 2072 of device 2070 when connected to the fluid conduit of the fluid management system. Two different sites can be aspirated. In use, the hinge 2084 of the sheath 2073 can be opened to increase the circumference of the opening 2085. The user can then more easily slide the device 2070 onto the existing tracheal tube before or after placing the tracheal tube in the patient's body. The coupler 2081 also exists to connect to the fluid management system. In a modification of this embodiment, more than two lumens are arranged along the circumference of the device sheath.

FIG. 21 illustrates an embodiment of a respiratory insertion device 2170 for removing fluid from two or more areas along a tracheal tube according to some embodiments. Device 2170 comprises one or more sleeves 2173. The sleeve 2173 has a function much like a stent, which expands laterally when a force is applied longitudinally, so that the device 2170 is inserted piece by piece onto the existing tracheal tube. obtain. The device 2170 may include a lumen along the circumference of the apex sleeve that extends along the longitudinal axis of the apex sleeve. The apex sleeve may include a lumen that terminates at the apex sleeve port opening to aspirate a first region along the existing tracheal tube. The first area may correspond to the oral cavity of the intubated patient. Lumens 2174, 2175, and 2176 are shown to enter sleeve 2173 at ring 2182. The top sleeve can be aligned and coupled to the lower sleeve with a corresponding lumen that terminates at the port opening along the length of the lower sleeve. The first port opening 2177 may correspond to the patient's oral cavity. Other port openings 2178 and 2179 may correspond to second and third regions along existing tracheal tubes such as the oropharynx and lower glottis. All lumens in FIG. 21 are shown to be inserted mostly in one position on the sleeve, but different lumens are inserted in different positions on the ring to provide the corresponding flow path within the lower sleeve. It is also possible to have. Also, each lumen is equipped with a coupler 2181 for attachment to a fluid management system or the like. It should be noted that when positioning this device embodiment, ventilation may have to be blocked for a short period of time so that the sleeve can be fitted over the existing tracheal tube.

Figures 22A-22C illustrate aspects of the respiratory insertion device 2270 for removing fluid from two or more areas along the tracheal tube according to some embodiments. Device 2270 is designed to fit onto an existing tracheal tube and comprises a series of stack rings 2822 that are grouped together by a series of support structures 2273. The stack ring 2282 may have at least one set of longitudinally aligned ring openings. Device 2270 further comprises an integrated lumen 2281 that can reach various locations along the length of the existing tracheal tube. The distal end of the integrated lumen 2281 comprises a series of tentacle-like lumens that sew through at least one of the longitudinally aligned ring openings 2288. A tentacle-like lumen at the distal end that can reach further along the existing tracheal tube sews through two or more of the longitudinally aligned ring openings 2288. obtain. The tentacle-shaped lumens 2274, 2275, and 2276 terminate with the corresponding suction ports 2277, 2278, and 2279 that can remove fluid from the corresponding area along the existing tracheal tube. Finally, the lumens come together at the proximal end of the integrated lumen 2281 and connect to the connector 2281 that connects the lumen to the fluid management system.

Figures 23A-23B illustrate aspects of the respiratory insertion device 2370 for removing fluid from two or more areas along the tracheal tube according to some embodiments. Device 2370 can be attached to an existing tracheal tube. The device 2370 comprises a device body 2373 along one side and a series of clips 2383 that allow the device 2370 to be attached to an existing tracheal tube. Each series of clips 2383 comprises an opening 2385 that allows the user to slightly increase the diameter of the series of clips 2383 to fit the device 2370 onto an existing tracheal tube. The device 2370 comprises a cavity 2386 that runs essentially the entire length of the device 2370. Although not shown, a catheter or tubing can be inserted through cavity 2386 to terminate at various locations along device 2370 for aspiration at different areas along the tracheal tube.

An alternative embodiment of device 2370 is device 2470 as shown in FIGS. 24A-24B. One of the differences between the devices 2470 and 2370 is that the device 2470 is made of two different materials. The majority of device 2470 is made of a softer elastomer that is flexible along the longitudinal axis of the device. Device 2470 comprises a region having a "C" shaped support 2487 containing a harder material. The C-shaped support 2487 sits along the longitudinal axis of the device 2470, providing overall rigidity within the cross section of the device 2470. The device 2470 includes a flow path 2486 that runs along the curve of the device body and follows the curve. Channel 2486 may hold at least one catheter or tubing body for suction in at least one area along the existing tracheal tube. If multiple catheters or tubing bodies are held within the flow path 2486, the distal ends of the catheter or tubing bodies terminate at different locations along the existing tracheal tube.

Next, FIGS. 25A-25C illustrate aspects of the respiratory insertion device 2570 for removing fluid from two or more regions along the tracheal tube according to some embodiments. Device 2570 is a modified form of clip format. Device 2570 has a proximal end 2571, a distal end 257, and a device body 2573. The proximal end 2571 is located near the patient's mouth, while the distal end 257 is located between the patient's lower trachea and bronchi. FIG. 25A is an enlarged view of the proximal end 2571 with a series of channels 2586 that follows the length of the device body 2573 and terminates at various locations along the existing tracheal tube. In some examples, channel 2586 corresponds to the patient's oral cavity, oropharynx, and lower glottis. Figures 25B and 25C show that some of the channels 2586 terminate at three ports 2574, 2575, and 2576 to aspirate different regions along the existing tracheal tube. Depending on how the fluid conduit is attached, some of the channels can be used to clean various areas of the patient's oral cavity, oropharynx, and subglottic cavity. Finally, the device 2570 comprises an opening 2585 that allows the device 2570 to be easily placed on the tracheal tube.

26A-26C show a modification of the device illustrated in FIGS. 25A-25C. Similarly, device 2670 has a clip-on form that allows it to be attached to an existing tracheal tube. The device 2670 includes a device body 2673, a proximal end 2671, and a distal end 2672. The device 2670 also has a C-shaped cross section with an opening 2685, the distance of the openings being greater than the device 2570. Proximal end 2671 of device 2670 is equipped with two couplers 2681 that allow the device 2670 to be connected to a suction system such as the fluid management system described earlier. The coupler 2681 is mounted on channels 2674 and 2675 that run along the length of device 2670 and terminate in different zones along device 2670. At the ends of channels 2674 and 2675 are ports 2674 and 2675 for aspirating different regions along the existing tracheal tube.

27A-27D illustrate aspects of the respiratory insertion device 2770 for removing fluid from two or more areas along the tracheal tube according to some embodiments. Device 2770 is another version of a clip-on fluid suction device that can be fitted into an existing tracheal tube. Device 2770 has a device body 2773, a proximal end 2771 closer to the patient's oral cavity during use, and a distal end 2772 between the patient's lower trachea and bronchi during use. Device 2770 comprises a series of clips 2783 for binding to the tracheal tube. Device 2770 also comprises laminated lumens 2774, 2775, and 2776 that run along the length of device body 2773 and terminate at different regions along device body 2773. Correspondence that works in conjunction with the fluid management system described above or other similar systems for detecting and aspirating fluid from different regions along the tracheal tube at the ends of lumens 2774, 2775, and 2776. There are ports 2777, 2778, and 2779. Although not shown, the proximal ends of lumens 2774, 2775, and 2776 can be coupled to the fluid pathways of fluid management systems or other similar systems.

Figures 28A-28G illustrate aspects of the respiratory insertion device 2870 for removing fluid from two or more areas along the tracheal tube according to some embodiments. Device 2870 is an integrated tracheal tube with sensing and suction functions as well as an airway passage for connecting to an external respiratory mechanism. The device 2870 includes a device body 2873, a proximal end 2871, and a distal end 2872. The cuff 2891 is located towards the distal end 2872 of device 2870. Device 2870 further comprises a tracheal tube portion 2890, a cuff inflatable tract 2892, and first, second, and third lumens 2874, 2875, 2876, thereby aspirating different areas along the patient's respiratory tract. To do. The distal ends of lumens 2874, 2875, and 2876 all terminate with corresponding ports 2877, 2878, and 2879 that assist in sensing and removing fluid from different locations along the device body 2873. FIG. 28G shows a cross section of this particular embodiment of the respiratory insertion device 2870, which further comprises an internal port 2893 for suction in the internal region of the tracheal tube portion of the respiratory insertion device 2870. Also visible channels are associated with ports 2877 and 2878 corresponding to the oral and oropharyngeal cavities.

A device for use in a tracheostomy scenario will be described with reference to FIGS. 29A-30. 29A and 29B show a first embodiment of the tracheostomy device 2970. The device 2970 comprises a proximal end, a distal end 2972, and a device body 2973 with one or more (eg, three in this example) fluid line connectors 2971, 2971', 2971'. Part 2973 bifurcates into first and second lumens 2974 and 2976. At use, the first lumen 2974 is located outside the tracheostomy tube, while the second lumen 2976 Most are located within the tracheostomy tube as shown in Figure 29B. The first lumen 2974 is the first of the tracheostomy tubes, primarily above the inflatable cuff 2991 of the tracheostomy tube. It has a first port 2977 at its end that is used to detect and remove fluid from its outer surface. The second lumen 2976 is longer than the first lumen 2974 and has a bend at its end. At the bend, the second lumen 2976 exits the tracheostomy tube and terminates under the cuff 2991. At the end, the second lumen 2976 exits the tracheostomy tube just below the cuff 2991. It comprises a second port 2979 for sensing and aspirating the lower region of the tube. The second lumen 2976 is inside the tracheostomy tube for sensing and removing fluid from the lower portion of the tracheostomy tube, and its. It also features a third port 2978 located near the distal end. Finally, the device 2970 can be attached to a fluid management system or similar system that senses and removes fluid from different areas along the tracheostomy tube. It is equipped with a connector 2981.

A second embodiment of the tracheostomy tube device 3070 is shown in FIG. Device 3070 is an integrated tracheostomy tube and fluid sensing and management device. Device 3070 comprises three independent lumens 3074, 3075, and 3076 integrated with a tracheostomy tube 3073. Proximal ends of lumens 3074, 3075, and 3076 include couplers 3081 for connecting to fluid management systems or other similar systems. The ends of each lumen 3074, 3075, and 3076 are at different sites along the tracheostomy tube 3073. At the ends of each lumen 3074, 3075, and 3076 are corresponding ports 3077, 3078, and 3079 for sensing and removing fluid from the corresponding area. In some cases, a fluid such as the wash fluid 3050 can be introduced into the tracheostomy tube 3073 and the rinse fluid can be removed via ports 3077, 3078, and 3079.

<u style="single">How to use a fluid management system with a respiratory insertion device</u> The next paragraph describes how to use a fluid management system with a respiratory insertion device. The user performs the task of inserting a respiratory insertion device having multiple openings into the respiratory tract of the subject, with the first opening positioned in the oral cavity (eg, near the base of the subject's tongue) and the second opening. It can be done so that it is positioned in the subject's mesopharynx and the third opening is positioned in the subject's lower girdle. In some cases, the respiratory insertion body is attached to an existing tracheal tube, and in other cases, the respiratory insertion body incorporating the tracheal tube is newly inserted into the patient's trachea.

Next, the user connects the first lumen of the breathing insertion body that communicates with the first opening to the first fluid conduit, and the breathing insertion body that communicates with the second opening. By connecting the second lumen of the part to the second fluid conduit and connecting the third lumen of the respiratory insertion body, which communicates with the third opening, to the third fluid conduit. Respiratory insertion Connect the body to the controller. The operator then automatically applies suction through each of the first, second, and third fluid lines for a predetermined period of time, and the fluid flow rate through one of the fluid lines is the flow threshold. Automatically turns off suction in one or the first, second, or third fluid line when it is lower and when the pressure in the fluid line is higher than the pressure threshold, and that fluid line The controller can be configured to apply positive pressure in the fluid line to remove blockages when the fluid flow through the fluid is below the flow threshold and when the pressure is below the pressure threshold. The operator can also choose to apply the cleaning liquid to various areas along the tracheal tube.

When a feature or element is said herein to be "on" another feature or element, it can be directly above or intervening in the other feature and / or Elements can also exist. In contrast, when a feature or element is said to be "directly above" another feature or element, there are no intervening features or elements. Also, when a feature or element is said to be "connected," "attached," or "combined" to another feature or element, the feature or element is directly another. It is also understood that there may be features or elements that can be connected, attached, coupled, or intervening to the features or elements. In contrast, when a feature or element is said to be "directly connected," "directly attached," or "directly coupled" to another feature or element, the intervening feature or element The element does not exist. Features and elements described or illustrated for one embodiment, but so described or illustrated, may also apply to other embodiments. Also, one of ordinary skill in the art would have a reference to a structure or feature that is disposed "adjacent" to another feature that is above or below the adjacent feature. You will also understand what you get.

The terms used herein are intended to describe only certain embodiments and are not intended to limit the scope of the invention. For example, as used herein, the singular "one (a, an)" and "the" are also plural unless the context clearly indicates otherwise. Intended to include. The terms "comprises" and / or "comprising" as used herein are the features, features, processes, steps, operations described. , Operation, element, and / or the existence of a component, and one or more other features, features, processes, steps, actions, operations, elements, and / or components, and / or a group of them. It will also be further understood not to exclude existence or addition. As used herein, "and / or" includes any combination of one or more of the related listed items and may be abbreviated as "/".

Spatial relatives such as "bottom", "below", "bottom", "top", "top", and similar words are one element or feature and the other, as illustrated in the figure. It may be used herein to facilitate the description in describing the relationship with an element or feature of. It is understood that these spatial relative terms are intended to include different orientations of the device in use or in operation in addition to the orientations shown in the figure. For example, if the device in the figure is flipped, an element described as "below" or "directly below" another element or feature will be oriented "above" another element or feature. .. Thus, the exemplary term "down" can include both up and down orientations. The device can be otherwise oriented (rotated 90 degrees or otherwise), and the spatial relative descriptor used herein can be interpreted accordingly. Similarly, "upward", "downward", "vertically", "horizontally", and similar terms are used herein only for illustration purposes unless otherwise noted.

Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements are contextual. It should not be limited by those words unless it should be understood in other ways. These terms can be used to distinguish a feature / element from another feature / element. Therefore, the first feature / element described below is referred to as the second feature / element, and similarly, the second feature / element described below is referred to as the first feature / element. Even if there is, it does not deviate from the teaching of the present invention.

Throughout this specification and the following claims, "comprise" and "comprises" and "comprising", unless the context requires otherwise. A variety of components can be used in conjunction in methods and articles (eg, compositions and devices including devices and methods). For example, the term "comprising" is understood to imply inclusion of the elements or steps described and not exclusion of other elements or steps.

Although various exemplary embodiments are described above, a number of modifications can be made to the various embodiments without departing from the scope of the invention as described in the claims. .. For example, the order in which the various described method steps are performed can often be changed in alternative embodiments, in which one or more method steps are completely skipped. May be done. The optional features of the various device and system embodiments are included in some embodiments and may not be included in other embodiments. Therefore, the above description is provided solely for illustration purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

The examples and examples contained herein show, for example, specific embodiments in which the subject may be implemented, without limitation. As mentioned, other embodiments may also be utilized and may be derived from them, and therefore structural and logical substitutions and modifications may be made without departing from the scope of the present disclosure. Such embodiments of the means of the present invention apply herein to a single invention or invention, either individually or collectively, for convenience only, even if a plurality are actually disclosed. It may be referred to by the term "invention" without the intention of voluntarily limiting it to a concept. Thus, although specific embodiments are exemplified and described herein, arrangement configurations calculated to achieve the same objective may be used in place of the particular embodiments shown. The present disclosure is intended to cover all possible adaptations or modifications of various embodiments. After scrutinizing the above description, combinations of the above embodiments, and other embodiments not specifically described herein, will become apparent to those skilled in the art.

200 Fluid management system 201 Integrated controller 220 Fluid pipeline 230 Flow sensor 232 Suction / vacuum motion control 240 Pressure sensor 242 Pressure control 260 Single secretion recovery jar 270 Respiratory insertion device 1970 Respiratory insertion device 1971 Proximal end 1972 Distal End 1973 Device Body 1978 Port 1980 Device Fluid Pipeline 1981 Coupler 1990 Trache Tube 1991 Cuff