Rinse lumen suction endotracheal tube system

Abstract

The flush lumen suction interdilator system for tracheostomy tubes can be a suction powered system that can replace conventional catheter based endo-lumen suction, used alone for suction of the tracheostomy tube, or used for a combination of flush and endo-lumen suction. The interdilator includes a chamber or region, and apertures to facilitate endo-lumen suction and cleaning at multiple locations within the tracheostomy tube. It can be applied / actuated on demand or on a periodic or triggered interval by the patient, healthcare staff, carer or via an electronic system in a hospitalised patient / hospital or outpatient / mobile care setting.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to provisional patent application series 63 / 124,599, filed on December 11, 2020, which is incorporated herein by reference in its entirety.

[0003] background

[0004] Intubation refers to the placement of an endotracheal breathing tube into a patient's airway, terminating in the trachea. The breathing tube can be inserted orally, nasally, or via a tracheostomy—an insertion route through the skin and soft tissue of the neck—passing through and ultimately terminating in the trachea. These measures provide temporary or permanent support for breathing or ventilation. The risks and problems associated with the placement, use, and care of endotracheal breathing tubes range from discomfort and inconvenience to serious medical risks and adverse health outcomes.

[0005] For safe and comfortable use, tracheostomy tube care requires regular emptying of secretions from the innermost part of the tube (i.e., the "intraluminal space"). In some cases, this may need to be done frequently, every 30 minutes. Even without sedation, few patients are able to perform effective, safe, and regular tube-based intraluminal aspiration without assistance, making them dependent on others to perform this important task, often leading to depression, anxiety, and agitation. Even with assistance, patients frequently experience discomfort during aspiration procedures. This is for two reasons: first, frequent misuse of the aspiration catheter (i.e., the aspiration catheter is inserted too deep / proximal into the airway); and second, patients' inability to apply aspiration (negative pressure) at regular intervals during their respiratory cycle, resulting in "surprising" aspirations and the resulting lack of respiratory sensation, changes in airway pressure, and activation of the cough reflex.

[0006] Figures 7A-7C illustrate various aspects of the basic anatomy of endotracheal tubes and the features of existing tracheostomy tubes. Figure 7A is a cross-sectional side view of a patient 700, showing various types of endotracheal tubes. Figure 7B is a perspective view of a tracheostomy tube with an internal cannula, and Figure 7C is a perspective view of a perforated tracheostomy tube and an internal cannula. Figures 7A-7C are best viewed together in the following discussion.

[0007] Patient 700 has a trachea 702, which is part of the airway leading to the lungs (not shown) of patient 700. To support breathing, patient 700 can be intubated in several ways as shown in Figure 7A. Intubation can be achieved via path 704, inserted through the nasal passage, across the vocal cords 710, and into the trachea 702, using a longer nasotracheal tube. Alternatively, a similarly long oral endotracheal tube can be inserted through path 706 into the trachea 702 via the mouth. Furthermore, a shorter tracheostomy tube 708 can be directly inserted into the trachea 702 through the surgical tracheostomy area 712.

[0008] During positive pressure or mechanical ventilation, an inflatable cuff 714 surrounding the tracheostomy tube 708 can be inflated via a cuff inflation valve 716, an external monitoring cuff 718, and associated tubing 720 to provide a seal between the tracheostomy tube 708 and the trachea 702 to prevent air leakage around the tube. This is referred to as a “cuffed” tube. Depending on the patient’s needs, the cuff 714 can be inflated or deflated. Comparable tubes without such a cuff are referred to as “cuffless” tubes, as shown, for example, in Figure 7C.

[0009] As shown in Figure 7B, the tracheostomy tube 708 includes a flange 722 that is positioned against the neck of the patient 700 to hold the tracheostomy tube 708 in the correct position and provide some functionality. A removable end-tubular tube 724 is an additional feature of some prior art tracheostomy tubes and can be combined with cuffed or uncuffed tracheostomy tubes. Air is exchanged with the patient 700 via the innermost lumen of the tracheostomy tube 708 (or the inner surface or lumen of the end-tubular tube 724, if present) through a hub 726. The hub 726 of the end-tubular tube 724 includes a clip 728 that engages with a clip attachment 730 on the flange 722.

[0010] Figure 7C illustrates the principle of a perforated tracheostomy tube. A perforation 732 is included in the tracheostomy tube 708 above region 734, where an inflatable sac will be positioned. A corresponding perforation 736 may be included in the endotracheal tube 724 if used. Perforations 732 and 736 allow airflow, which allows the patient 700 to speak and cough more effectively. The methods, concepts, and designs used and described in this article for tracheostomy tubes can also be applied to nasotracheal tubes and orotracheal tubes.

[0011] Most existing methods of secretion management use only suction to remove secretions from the tracheostomy tube. Currently, there is no safe way to flush the lumen of the tracheostomy tube to prevent the accumulation of secretions, obstruction, and acute airway loss. As a result, patients may require higher levels of intervention or additional procedures due to inadequate cleaning of the tracheostomy tube.

[0012] Existing techniques for clearing secretions from endotracheal tracheostomies using manually aspirated catheters can also pose risks of infection to patients and frequently cause airway trauma. It can also lead to significant psychosocial distress for both patients and caregivers, displaced patient autonomy, a heavy burden on healthcare resources, and a burden on caregivers who may be exposed to airborne pathogens from the patient's airway. This clearance also requires frequent procedures, further increasing the time and resource burden on healthcare and / or caregivers and leaving patients passive in their own care.

[0013] Currently available tracheostomy tubes with combined flushing and / or aspiration functions are located at a single site within the airway (i.e., subglottic / "supraclavicular" or proximal tip), and most commonly not within the lumen of the tube. Those that empty the lumen of the tube cannot address the distal tip or extraluminal portion, and furthermore, doing so without flushing makes them susceptible to impending airway loss due to obstruction. None of these devices are widely accepted in clinical use; therefore, obstruction / airway loss, infection, and the burden of standard, manual, catheter-based endoluminal aspiration systems remain major aspects of tracheostomy tube care. Additionally, failure or obstruction of these designs often necessitates removal of the entire tracheostomy tube for treatment, which can be dangerous.

[0014] Overview

[0015] An intraluminal aspiration cannula system for tracheostomy tubes can be a suction-powered system that can replace conventional catheter-based intraluminal aspiration, used alone for tracheostomy tube aspiration, or in combination with flushing and intraluminal aspiration. The cannula includes a chamber or region, and orifices to facilitate intraluminal aspiration and cleaning at multiple locations within the tracheostomy tube. It can be applied / actuated on demand, periodically, or at trigger intervals by the patient, healthcare worker, caregiver, or via an electronic system in inpatient / hospital or outpatient / mobile care settings.

[0016] In a first aspect, the endotracheal tube used with the tracheostomy tube includes a first tube having a first diameter for insertion into the tracheostomy tube, the first tube further including a plurality of holes between a lumen space of the first tube and an outer surface of the first tube, and one or more ridges on the outer surface of the first tube dividing an air gap around the outer surface into a plurality of regions; and a second tube fused to the distal end of the first tube and having a second diameter greater than the first diameter, the second tube including a first channel between the outer surface of the second tube and a first region in the plurality of regions, and a second channel between the outer surface of the second tube and a second region in the plurality of regions.

[0017] In a second aspect, the endovascular flushing and aspiration cannulation system includes an external tracheostomy tube and an endovascular cannula positioned within the external tracheostomy tube. The endovascular cannula includes a first tube having a first diameter for insertion into the external tracheostomy tube, the first tube further including a plurality of holes between a luminal space within the first tube and an outer surface of the first tube, and one or more ridges on the outer surface dividing an air gap between the outer surface of the endovascular cannula and the inner surface of the external tracheostomy tube into a plurality of regions; and a second tube fused to the distal end of the first tube and having a second diameter greater than the first diameter, the second tube including a first channel between the outer surface of the second tube and a first region within the plurality of regions, and a second channel between the outer surface of the second tube and a second region within the plurality of regions. The system also includes a flushing line attached to the first channel in the second tube and communicating with the first region, an aspiration line attached to the second channel in the second tube and communicating with the second region; and an actuation device coupled between the flushing line and a flushing source and between the aspiration line and a vacuum source, the actuation device controllably connecting the flushing line to the flushing source and the aspiration line to the vacuum source.

[0018] In a third aspect, the flushing and endovascular aspiration and extraluminal aspiration cannulation system includes an external tracheostomy tube and an endovascular cannula, the external tracheostomy tube including one or more openings along its length, the endovascular cannula being positioned within the external tracheostomy tube, the endovascular cannula including a first tube having a length and diameter for insertion into the external tracheostomy tube, the first tube further including a plurality of openings between the luminal space of the first tube and the outer surface of the first tube, a first ridge dividing the outer surface of the first tube into a flushing region and a first aspiration region, and a second ridge creating a second aspiration region on the outer surface of the first tube; and a second tube fused to the distal end of the first tube and having a diameter greater than that of the first tube. The system also includes a flushing line attached to a flushing channel in the second tube and communicating with an air gap formed between the outer surface of the first tube and the inner surface of the external tracheostomy tube in the flushing area; a first suction line attached to a first suction channel in the second tube and communicating with an air gap formed between the outer surface of the first tube and the inner surface of the external tracheostomy tube in the first suction area; a second suction line attached to a second suction channel in the second tube and communicating with an air gap formed between the outer surface of the first tube and the inner surface of the external tracheostomy tube in the second suction area; and an actuation device coupled between the flushing line and the flushing source and coupled between the first and second suction lines and a vacuum source, the actuation device controllably connecting the flushing line to the flushing source and connecting the first and second suction lines to the vacuum source.

[0019] On the other hand, a method for cleaning a tracheostomy tube includes attaching an aspiration line to an internal tube such that it communicates with a first region of a plurality of regions; attaching an actuation device between the aspiration line and a vacuum source, the actuation device controllably connecting the aspiration line to the vacuum source; and controlling the actuation device to aspirate from the lumen of the internal tube through a first portion of a plurality of holes, a first region, and the aspiration line, the tracheostomy tube having an external tracheostomy tube and an internal tube, the internal tube including a plurality of holes and, when the internal tube is inserted into the external tracheostomy tube, dividing the air gap between the external tracheostomy tube and the internal tube into one or more ridges of a plurality of regions.

[0020] Furthermore, the method may include attaching a flushing line to the inserting tube such that it communicates with a second region within a plurality of regions; attaching an actuation device between the flushing line and a flushing source, the actuation device controllably connecting the flushing line to the flushing source; and controlling the actuation device to provide flushing to the lumen of the inserting tube through a second portion, a second region, and the flushing line in a plurality of orifices.

[0021] If desired or desirable, the use of an intraluminal flushing aspiration cannulation system does not preclude the use of currently standard catheter-based intraluminal aspiration. The use of an intraluminal flushing aspiration cannulation system also does not limit the use of existing subglottic extraluminal (e.g., subglottic) aspiration systems, and these designs can be combined.

[0022] In cases where the performance of the endovascular flushing system is not optimal, the endovascular tube can be removed and replaced without removing the tracheostomy tube. Finally, in certain situations (e.g., when attached to mechanical ventilation, or when using an external filter or other such cap to restrict secretions), the endovascular flushing system enables flushing and aspiration within a “closed system,” thereby reducing or eliminating the potential for infectious aerosols and / or particles resulting from aspiration of tracheostomies using existing “open” tube-based catheters, thus lowering the risk of respiratory pathogens to healthcare workers and caregivers.

[0023] The implementation scheme of the endoluminal aspiration cannulation system for flushing disclosed herein addresses these problems through its novel design and use in a closed system, as described below. For example, by creating a separate chamber for aspiration and flushing within the tracheostomy tube—the endoluminal aspiration cannulation system for flushing—achieves endoluminal aspiration and flushing of tracheostomy in a manner currently unavailable. As a result, the disadvantages and risks of the prior art are avoided.

[0024] Brief description of the attached figures

[0025] Figure 1A This is a side view of the flushing lumen and aspiration cannula in the implementation scheme.

[0026] Figure 1B yes Figure 1A A perspective view of the intubation tube.

[0027] Figure 1C yes Figure 1A A top view of the intubation tube.

[0028] Figure 1D yes Figure 1A A bottom view of the intubation tube.

[0029] Figure 1E yes Figure 1A A cross-sectional view of the internal insertion tube.

[0030] Figure 2A This is a cross-sectional side view of the aspiration cannula within the flushing lumen with an external cavity in the implementation scheme.

[0031] Figure 2B yes Figure 2A A perspective view of the cannulation system.

[0032] Figure 2C yes Figure 2A An unfolded diagram of a part of the intubation system.

[0033] Figure 3 This is a side view of the cannula with flushing and suction connections in the implementation scheme.

[0034] Figure 4 It is the flushing lumen aspiration and internal cannulation system in the implementation plan.

[0035] Figure 5 This is a flowchart illustrating the method of using a flushing lumen aspiration intracannulation system.

[0036] Figure 6A This is a perspective view of the implementation scheme, which combines additional extraluminal subglottic aspiration capabilities with an accompanying enclosed external tracheostomy tube for flushing, intraluminal aspiration, and endotracheal intubation.

[0037] Figure 6B This is a perspective view of the alternative flushing intraluminal aspiration cannulation system in the implementation plan, which combines additional extraluminal subglottic aspiration capabilities with an accompanying bagged external tracheostomy tube.

[0038] Figure 6C This is a perspective view of the flushing and aspiration system for the combined subglottic region outside the lumen, with an accompanying specially designed pouched external tracheostomy tube, in the implementation scheme.

[0039] Figure 6D-6E This is a perspective view of the flushing lumen aspiration endotracheal tube system used in the implementation scheme with a perforated external tracheostomy tube.

[0040] Figure 7A is a cross-sectional side view of a patient showing various types of prior art endotracheal tubes in the implementation scheme.

[0041] Figure 7B is a perspective view of a prior art tracheostomy tube with an internal cannula in the implementation scheme.

[0042] Figure 7C is a perspective view of the prior art perforated tracheostomy tube and internal cannula in the implementation scheme.

[0043] Detailed Explanation

[0044] The principles of this disclosure can have specific applications in tracheostomy tubes, and therefore will be primarily described herein. However, it should also be understood that the principles and aspects of this disclosure are applicable to tubes via the endotracheal cavity or nasotrachea, or other flushing and aspiration catheters used in healthcare or industry.

[0045] In the above and subsequent discussions, the term "proximal" is used to refer to the lung closer to the patient and / or the lung-side tip closer to the tracheostomy tube. The term "distal" is used to refer to the outer end of the device or tracheostomy tube further away from the patient and / or facing outwards from the patient. Other terms used herein may be defined as follows:

[0046] Cannulation – A tube inserted into a body cavity, catheter, or blood vessel.

[0047] Lumen – the space inside the cannula.

[0048] Inside the lumen—in the innermost lumen, between the ends of the cannula.

[0049] Extraluminal – outside the cannula or at either end of the cannula. As used herein, “extraluminal” applies to the outermost tube or either end of the cannula or insertion tube in any case.

[0050] Subglottic – typically located below the glottis. As used in this article, “subglottic” refers to the extraluminal region of the trachea, above the inflatable sac of the endotracheal tube and below the vocal cords.

[0051] The innermost airway lumen diameter of endotracheal tubes (including tracheostomy tubes) ranges from 2 mm in neonatal tubes to approximately 14 mm in adults, with the lower limit constrained by the effective airflow / ventilation into and from the patient's airway. The upper limit is influenced by the outer diameter of the endotracheal tube or tracheostomy tube and its fit within the airway—specifically, its ability to pass over the vocal cords / glottis and enter the trachea—and is generally limited to a size not exceeding approximately 15 mm.

[0052] The flushing and aspiration endovascular cannulation system discussed in this article typically includes a tracheostomy tube and an endovascular cannula. The endovascular cannula is inserted into the tracheostomy tube and provides aspiration and flushing of the tracheostomy tube. Figure 1A-1D An internal cannula 100 is depicted in one embodiment, while Figure 2A-2C The illustration depicts an internal cannula 100 combined with a tracheostomy tube in an embodiment to form an internal cannula 200 of an intraluminal aspiration internal cannula system.

[0053] Figure 1A A side view of the internal cannula 100 with intraluminal aspiration and flushing is shown in the embodiment. Figure 1B , 1C The oblique view, top view, and bottom view of the internal cannula 100 are shown in 1D and 1D respectively. Figure 1E yes Figure 1A Sectional view along line 1E-1E. Figure 1A-1E It is best to view them together in the following descriptions.

[0054] The endotracheal tube 100 includes a single, curved, semi-rigid plastic tube 102 fused to a rigid plastic tube 104. The endotracheal tube 100 can be fitted to the patient's existing tracheostomy tube 202 (e.g., ...). Figure 2A -2D) or fitted into a specially designed tracheostomy tube for use with the internal intubation tube 100. The external tracheostomy tube 202 may or may not be equipped with a balloon (such as) for use with positive pressure ventilation (i.e., "cuffed" or "uncuffed" tracheostomy tubes) known in the prior art. Figures 6A-6E (The endotracheal tube 100 is secured with a suitable retaining clip 106 for the patient's natural gas stoma tube 202 or an accompanying specially designed tracheostomy tube.) The endotracheal tube 100 can have various diameters, thicknesses, and lengths, depending on, for example, the patient's needs or its application in the endotracheal tube. In an embodiment, the semi-rigid plastic tube 102 has a smaller diameter than the rigid plastic tube 104. An intraluminal space 132 is formed throughout the interior of the endotracheal tube 100.

[0055] The endotracheal tube 100 includes a specific arrangement and a continuously rising ridge 112 on the outer surface of the tube 102 adjacent to the lumen of the rigid external tracheostomy tube 202. The ridge 112 divides the outer surface of the tube 102 into several regions 124, 126, or chambers. Starting at point 114 where the tube 102 merges into the tube 104, the ridge 112 extends along the length of the tube 102 in a proximal direction, circles the circumference of the tube 102 at point 116, and then returns along the tube 102 in a distal direction. Before reaching the tube 104, the ridge 112 again circles the circumference of the tube 102 at point 118, extends in a proximal direction to point 120, and then supports the tube 102 at point 122 where the tube 102 merges into the tube 104.

[0056] Regions 124 and 126 of the tube 102 formed by the ridge 112 each include a series of openings between their outer surface and the internal space 132 to allow movement of air and / or fluid. Region 124 includes an orifice 125 and is located on either side of the tube 102, while region 126 includes a groove 127 and is located at the top and bottom of the tube 102. Although orifices and grooves are shown, this is for illustrative purposes. In embodiments, the positions of the orifices and grooves may be reversed. Additionally, all openings may be grooves, or all may be orifices, or orifices 125 and 127 may have different sizes or other shapes to facilitate function. Similarly, in Figure 1A-1E The shape and orientation of the ridges are shown for illustrative purposes only and may be configured differently to facilitate the functions described herein.

[0057] In one embodiment, the rigid plastic tube 104 includes channels 128 and 130 positioned at 90 degrees to the retaining clamp 106, although other locations are contemplated, provided that channels 128 and 130 are connected to regions 124 and 126, respectively. Channels 128 and 130 may be slots or closed channels through the tube 104. Channel 128 extends at an angle from the upper outer surface of the tube 104 to an opening in the proximal end of the tube 104 adjacent to the tube 102. In one embodiment, channel 128 communicates with an air gap created by a ridge 112 between the adjacent inner surfaces of the external tracheostomy tube 202 in the tube 102 and region 124. An orifice 125 communicates between the air gap in region 124 and the lumen space 132. Similarly, channel 130 extends at an angle from the lower outer surface of the tube 104 opposite to channel 128 to an opening in the proximal end of the tube 104 adjacent to the tube 102 but opposite to the opening of channel 128. In one embodiment, channel 130 also communicates with an air gap created between ridge 112 between the adjacent inner surfaces of tube 102 and external tracheostomy tube 202, but in region 126, not region 124. Region 126 includes groove 127, which also communicates between the air gap in region 126 and the intraluminal space 132.

[0058] Such as combination Figure 3 In more detail, flexible plastic tubes of different diameters, thicknesses, and lengths can be connected to channels 128 on the upper surface of tube 104. As discussed further below, flexible plastic tubes of different diameters, thicknesses, and lengths can be connected to channels 130 on the lower surface of tube 104. The references to upper and lower surfaces are for illustrative purposes, and channels 128, 130 can be located anywhere around tube 104.

[0059] Figure 2A-2C This image shows an internal cannula 100 that will be inserted into an external tracheostomy tube 202 to create an intraluminal aspiration cannula system 200. (The following is not specifically described.) Figure 2A-2C The components combined with the above Figure 1A-1E The components described are the same.

[0060] System 200 includes an external tracheostomy tube 202, which represents a patient's existing tracheostomy tube or a tracheostomy tube specifically designed for use with the internal intubation tube 100. In embodiments, the specially designed external tracheostomy tube 202 can mate with the internal intubation tube 100 as part of a kit. For example, the external tracheostomy tube 202 may have a notch in its inner surface that engages with the spine 112 and improves the function of the internal intubation tube 100. Figure 2A As shown, only a portion of the external tracheostomy tube 202 is displayed. A portion of the external tracheostomy tube 202 is cut open to show the tube 102 and the engagement between the ridge 112 and the inner surface of the external tracheostomy tube 202. Additionally, the external tracheostomy tube 202 extends toward the tube 104 and provides a mechanism for engaging the retaining clip 106. This mechanism can have several different forms and is omitted for clarity. Figure 2B A system 200 with a complete external tracheostomy tube 202 is shown.

[0061] The length of the external tracheostomy tube 202 is approximately equal to that of the internal insertion tube 100, such as... Figure 2B As shown. The diameter of the external tracheostomy tube 202 is selected such that the ridge 112 abuts the inner surface of the external tracheostomy tube 202, as shown at point 134, to form an air gap divided into regions 124 and 126. The end 136 of the channel 128 in tube 104 communicates with region 124, while the end 138 of the channel 130 communicates with region 126 in tube 104. Figure 1C and 1D As shown more clearly, region 126 includes areas on opposite sides of tube 102. In an embodiment, ridge 112 may be formed at an internal level as part of external tracheostomy tube 202 while still providing the regions or chambers discussed above. Alternatively, ridge 112 may be formed as part of both internal tube 100 and external tracheostomy tube 202, thereby creating a single, inseparable device.

[0062] During the procedure, the endotracheal tube 100 can be used to aspirate and clear secretions from the patient's tracheostomy tube. Secretions accumulate on a routine basis and typically require a suction procedure using an endotracheal tube, which is currently usually performed by another person and is often too sticky to retrieve easily. The endotracheal tube 100 can be fitted into an existing tracheostomy tube or a specially designed accompanying tracheostomy tube. Once secured with the retaining clip 106 of the patient's natural tracheostomy tube (or accompanying tracheostomy tube), aspiration can be applied alone or in conjunction with irrigation to remove secretions from the luminal space of the patient's tracheostomy tube and adjacent ends. In embodiments, aspiration or aspiration and irrigation can also be applied to the subglottic region outside the lumen. Irrigation can be performed with an irrigation solution, such as saline. In embodiments, other solutions such as mucolytics, antibiotics, antifungals, steroids, or other medications can be used. Flushing combined with aspiration also flushes the lumen of the tracheostomy tube and the aspiration chamber, thus thinning (reducing viscosity) the secretions to allow for easier aspiration and removal, thereby preventing buildup and blockage, and reducing the burden of pathogen colonization in the tube and airway tissues.

[0063] In the implementation plan, combined with Figure 3 and Figure 4 Methods of intubation using any of the methods disclosed herein are described, and are preferably viewed together with the following description. For illustrative purposes, an internal cannula 100 without an external tracheostomy tube 202 is depicted. The internal cannula 100 fits into a) the patient's existing tracheostomy tube or b) an accompanying specially designed tracheostomy tube—both options are represented by an endovascular flushing aspiration internal cannula system 200 as disclosed herein. Once secured with a retaining clip 106 to the patient's natural tracheostomy tube or an accompanying specially designed tracheostomy tube, the proximal end of the aspiration line 302 is received by a channel 130. The aspiration line 302 may be a flexible plastic tube terminated by fusion with a standard aspiration application tip 304. The proximal end of the flushing line 306 is received by a channel 128. The flushing line 306 may be a flexible plastic tube terminated by fusion with a standard intravenous (IV) conduit connection 308, such as a Luer lock. In the implementation, the suction line 302 and the flushing line 306 have a static / fail-safe closed position that prevents: a) loss of positive pressure (i.e. leakage) in a mechanically ventilated setup, b) spontaneous flow of flushing fluid, and c) spontaneous application of suction to the device.

[0064] Figure 4A flushing lumen aspiration cannulation system 200 is shown, which connects to other devices to form an active use system 400. The active use system 400 is an example of the system 200 in use. The distal end of the aspiration line 302 is applied to the aspiration line input 402 on the actuator 404. The aspiration line 406 at the distal end of the actuator 404 is coupled to the input 408 of the vacuum source container 410. The container 410 can be connected to a continuous aspiration / negative pressure source, such as, for example, a wall-mounted vacuum fitting in a hospital or a portable aspiration unit.

[0065] Similarly, the flushing line 306 from the endotracheal tube 100 is coupled to a suitable flushing line input 412 on the actuator 404. The flushing line 414 distal to the actuator 404 is applied to the flushing bottle 416 via a cap 418 having a suction tube extending to the bottom of the bottle. A vent 420 on the cap 418 can be opened to facilitate use and promote a flow of flushing fluid with minimal resistance. The flushing bottle 416 must be placed on the floor near the patient or always maintained at least one vertical foot (or other defined distance) below the patient's tracheostomy tube to prevent gravity flow when the actuator is open. In embodiments, the flushing bottle 416 may be, for example, a ventilation-optional flushing bottle or a hanging bag attached to the patient's bed or freestanding support.

[0066] once Figure 4 With all components properly secured, the actuator 404 is controlled to perform a suction operation only, or a combined suction and flushing operation is performed by actuating buttons 422 and 424. The suction-only actuation of button 424 aspirates air and secretions from the lumen space 132 of the inner tube 100 through the region 126 formed by the ridge 112 between the inner tube 100 and the tracheostomy tube 202 on the inner surface. Figure 2A -2D), and flows distally through lines 302 and 406 that ultimately terminate in the vacuum source container 410, thereby clearing secretions from the lumen. Although the actuator 404 is described in conjunction with a button, any mechanism for controlling the operation of the actuator 404 and the active use system 400 to provide the functions described herein can be used. Additional buttons and functions may also be provided as part of the actuator 404 and the active use system 400.

[0067] If both the suction button 424 and the flushing button 422 are actuated simultaneously, the flushing fluid generated at the distal end of the flushing bottle 416 will be aspirated through the suction lines 414 and 306 by the negative pressure applied by the suction lines 302 and 406. The flushing fluid will be aspirated into the region 124 formed by the ridge 112 between the inner surfaces of the internal cannula 100 and the external tracheostomy tube 202. The flushing fluid will enter the lumen space 132 of the internal cannula 100 through the orifice 125, mix with the air and secretions in the lumen, and then pass through the slot 127 ( Figure 1A-1DIt leaves and enters area 126. This flow of flushing fluid will thin the secretions and flush the lumen space 132 of the inner cannula 100, and eventually terminate in the vacuum source container 410.

[0068] The actuator 404 can be designed in a variety of ways, as long as it provides control buttons or other actuators, and connections between suction and flushing lines from the tracheostomy cannula and the flushing and suction sources, respectively. In embodiments, the actuator 404 includes buttons 422 and 424 that can be moved / pressed into alignment. More or fewer buttons may be provided. The outer plastic housing of the actuator 404 is shown to include an input 402 with a suction line 302, and an output on the opposite side of the intubation 100 providing suction for the line 406. The outer plastic housing of the actuator 404 also has an input 412 for the flushing line 306 and an output on the opposite side for the flushing line 414, which passes through a cap 418 into a standard flushing bottle 416. These inputs and outputs may be provided at any convenient location on the actuator 404. Actuation device 404 functions such that the lumens of the two lines 302 and 406 are aligned to allow flow only when button 424 is pressed, otherwise flow is blocked when button 424 is not actuated. Similarly, the lumens of lines 306 and 414 are aligned to allow flow only when button 422 is pressed. In an embodiment, actuation device 404 prevents the flow of irrigation fluid without aspiration; however, it will only be suitable for aspiration applications. Other actuation mechanism mechanisms for connecting lines 302 and 306 to lines 406 and 414, respectively, are considered. Furthermore, the actuation device can be provided as a component of another medical device.

[0069] The patient is protected from the influence of only the irrigating fluid flowing into the lumen space 132 of the endotracheal tube 100 by means of an actuation device 404 that prevents the flow of irrigating fluid without aspiration, and by ensuring that the irrigating bottle 416 is kept at least one foot (12 inches) – or other defined distance – to prevent spontaneous flow. In other words, the irrigating bottle 416 and any hanging bag or device used to provide irrigation must always be positioned below the vertical height of the tracheostomy tube without any other mechanism to limit the flow of irrigating fluid. Other methods of controlling the flow of irrigating fluid are considered. For example, the irrigating fluid could be actively propelled through the same flow pattern described above, but in a continuous or pulsating manner by means of a pump or pressurized irrigating canister, rather than simply by aspiration of negative pressure generated by a vacuum source 411. The pump could be placed proximal or distal to the actuation device. In an implementation, the orifice 125 in the inner cannula 100 may include a one-way valve or a pressure relief valve, such as a simple slit or defect in the material in the area, which remains closed at the baseline and opens as pressure increases in the flushing line near the actuator.

[0070] In implementations, the active use system 400 may include additional safety measures to prevent malfunctions. In the event of flushing or aspiration failure, a flow sensor (not shown) will monitor for excessive or unwanted flow of flushing fluid and provide an alarm or other notification, or a stop mechanism. Optionally, excessive flow of flushing fluid can be immediately stopped by removing the inner cannula. Valves, flow limiters, and mechanical or electrical and pressure sensors are also considered.

[0071] In the event of a malfunction, or for routine care, the endotracheal tube 100 can be released, removed, discarded, and replaced with a new tube. Routine catheter-based endotracheal aspiration can be performed with or without the endotracheal tube 100 in place. It is also noteworthy that this can be performed with or without a ventilator / positive pressure source. Furthermore, it can be performed with a cuffed or uncuffed tube, or with a perforated or non-perforated tracheostomy tube. Control of the actuation device 404 can be performed by the patient, healthcare provider, or caregiver. In an embodiment, the actuation device 404 can also be actuated by a mechanism designed to be maintained and applied by the patient, healthcare provider, or caregiver as needed, either on an automated schedule, or at points where certain monitoring input conditions are met and identified by an electronic monitoring system, via an electronically controlled device. The flushing bottle 416 can be replaced when it is depleted or as part of a set schedule. In addition, any component may be removed and replaced as required by the established schedule, or as indicated by the electronic monitoring system or established program, when deemed necessary by the patient, healthcare staff, or caregivers.

[0072] In the implementation, various methods can be used to manufacture the flushing lumen aspiration cannula system. For example, the cannula 100 or system 200 can be formed by die extrusion or by thermally and / or chemically fixing a solid plastic roll to the cannula to provide its ridged configuration. Holes 125 and grooves 127 on the tube 102 can be produced by die extrusion or by removing material via heat, drilling, cutting, grinding, or other methods. The tube 102 can be thermally and / or chemically fused to a rigid plastic tube 104. The tubes 102 and 104 can also be manufactured as a single piece. The flushing fluid / flushing line 306 and the aspiration line 302 can be thermally and / or chemically fused to the rigid plastic tube 104 in place. Additive methods, such as 3D printing, are also considered.

[0073] Figure 5 This is a flowchart illustrating a method 500 using an intraluminal aspiration cannulation system 200. Method 500 includes steps 506 and 508. In an embodiment, method 500 further includes at least one of steps 502 and 504.

[0074] In step 502, the intratracheostomy tube 100 is inserted into the external tracheostomy tube 202 to create an intraluminal aspiration intratracheostomy tube system 200. In an example of step 502, the intratracheostomy tube 100 fits into an existing external tracheostomy tube 202 or a specially designed accompanying tracheostomy tube. The intratracheostomy tube 100 is secured to the patient's natural gas tracheostomy tube 202 or accompanying tracheostomy tube with a retaining clip 106.

[0075] In step 504, the suction and flushing lines are connected to the inner cannula 100. In an example of step 504, the suction line 302 is attached to channel 130 in the tube 104. In an embodiment, the flushing line 306 is attached to channel 128 in the tube 104. In an embodiment, one or both of the suction line 302 and the flushing line 306 may be permanently attached to or fused to the tube 104.

[0076] In step 506, the suction and rinsing lines are connected to the vacuum source and the rinsing source via actuators. In an example of step 506, suction line 302 is connected to the vacuum source container 410 via actuators 404 and 406. Rinsing line 306 is connected to the rinsing bottle 416 via actuators 404 and 414.

[0077] In step 508, the actuator 404 is used to perform aspiration alone or in conjunction with flushing of the endotracheal tube 100 or system 200. In an example of step 508, button 424 on the actuator 404 can be pressed to connect the aspiration line 302 to the aspiration line 406, thereby removing secretions from the lumen space 132 of the patient's tracheostomy tube 202. Alternatively, flushing button 422 can be pressed to combine flushing / rinsing with aspiration, thereby allowing for easier aspiration and clearance within the closed system by thinning the secretions to clean the lumen space 132 and area 126 of the tracheostomy tube. The actuator 404 can be controlled by the patient, hospital staff, or other caregivers. In embodiments, the actuator 404 can be integrated into a ventilator (not shown) and programmed to coordinate with the operation of the ventilator. Furthermore, the actuation device 404 can be used in conjunction with an electronic control device to apply actuation / pressing of an actuation button (or other method). Another example is control via eye-controlled devices or neurally integrated devices, such as those used for immobile patients with neurodegenerative or paralyzed conditions (e.g., amyotrophic lateral sclerosis (ALS), trauma, etc.). In any of these embodiments, the actuation device can be actuated as needed by the patient, healthcare provider, or caregiver based on an automated schedule or at points that meet certain monitoring input conditions and are identified by an electronic monitoring system. In these embodiments, this provides additional flexibility, reduces the burden of care and resources, and minimizes the aerosolized particle exposure of others.

[0078] The accumulation of oral and pharyngeal secretions in the area above the cuff of the external tracheostomy tube can lead to microaspiration of secretions into the lungs and is associated with the development of ventilator-assisted pneumonia (VAP). For this reason, several alternative implementation schemes have been considered to incorporate separate extraluminal subglottic aspiration, or a combination of flushing and aspiration, in this area, while still incorporating the intraluminal flushing and aspiration described herein. Figures 6A-6C These implementation schemes are illustrated in the document. Additionally, the flushing lumen aspiration cannulation system described herein can also be used with a perforated external tracheostomy tube, and... Figure 6D-6E Another implementation scheme is shown in the figure.

[0079] Figure 6A It shows, as Figure 1A-1D The internal cannula 100 shown can be used with an external tracheostomy tube having a pouch 604 with an additional suction port 606. For example... Figure 6AAs shown, one or more suction ports 606 are provided in the cuffed external tracheostomy tube 602 in the subglottic region, specifically above the cuff 604 of the cuffed external tracheostomy tube 602 and below the vocal cords. The suction ports 606 may be located on the upper surface of the cuffed external tracheostomy tube 602 to overly correspond to the region 126 of the internal cannula 100, thereby extending intraluminal suction into the subglottic space. Additional suction ports 606 (not shown) may be provided on the opposite side of the cuffed external tracheostomy tube 602 aligned with the corresponding region 126. However, because the air gap of the lumen of the tracheostomy tube used for ventilation is adjacent to this extraluminal suction channel created by this design, air leakage into the subglottic space may occur during positive pressure ventilation, leading to discomfort or other problematic side effects. Additionally, this can create a pathway for subglottic secretions to enter the intraluminal space and be aspirated into the lower airway. Due to these drawbacks, two additional embodiments of subglottic aspiration and subglottic flushing and aspiration combinations were considered and shown. Figure 6B and 6C middle.

[0080] exist Figure 6B In this embodiment, the intravesical cannula 608 is an improvement upon the intravesical cannula 100. The following description refers to the accompanying drawings, wherein, unless otherwise indicated, the same numerals in the different drawings denote the same or similar elements. An additional channel 610 is created in the tube 104 for attaching a subglottic aspiration line (not shown). Channel 610 is an example of channel 130. Subglottic aspiration occurs in a region 612 created by a ridge 614 on the intravesical cannula. Ridge 614 is similar to ridge 112 in that it creates a region or chamber between the intravesical cannula 608 and the external tracheostomy tube 616. Ridge 614 begins at the tube 104, extends along the length of the intravesical cannula 608 in a proximal direction, circles the circumference of the intravesical cannula 608 at point 618, and then extends back along the length of the intravesical cannula 608 in a distal direction to terminate at the tube 104. Figure 6B As shown, the ridge 112 is reconfigured so that intraluminal aspiration or flushing and aspiration can be provided with the intratubular cannula 608 as described above.

[0081] It is noteworthy that region 612 does not contain the holes or slots present in region 126; therefore, there is no communication between region 612 or the space outside the lumen of the external tracheostomy tube 616 and the space inside the lumen of the internal cannula 608. Instead, slot 620 is located within the external tracheostomy tube 616, such that it covers region 612. This is achieved through the combination of... Figure 4 The actuation device is separated or similarly controlled so that when suction is applied through channel 610, secretions in the subglottic space outside the lumen will be removed by suction. Figure 6BThe implementation scheme only provides suction to the subglottic space outside the lumen. Channel 128 in tube 104 can be displaced from its position, such as... Figure 1A-1D As shown, it remains adjacent to region 124 and communicates with the opposite side of the flushing space of the inner cannula 608 via region 622. Therefore, a new suction path is created, while still supplying suction and flushing to all the aforementioned orifices in the inner cannula for the purpose of flushing within the lumen. This design sacrifices a small area of ​​upper lumen suction.

[0082] Figure 6C The proposed implementation combines flushing and suction in the subglottic region outside the lumen, while still achieving intraluminal suction and flushing. In this implementation, the channel 128 in tube 104 moves laterally again, but to the same extent as... Figure 6B In the same manner, it maintains its adjacency to region 124 via the same design of ridge 112, as... Figure 6B As shown. In Figure 6C In this design, ridge 614 is replaced by two parallel raised ridges, including an inner ridge 624 and an outer ridge 626. Both the inner ridge 624 and the outer ridge 626 originate from and terminate again in tube 104, as described above with respect to ridge 614. This creates region 628 within the inner ridge 624 and region 630 between the inner ridge 624 and the outer ridge 626. Similar to regions 124 and 126, regions 628 and 630 create a chamber between the internal cannula 632 and the external tracheostomy tube 634. There are no holes or slots in regions 628 or 630 for communication with the luminal space of the internal cannula 632. A channel 638 in tube 104 connects to a suction line (not shown) and is adjacent to region 628 for providing suction to the subglottic region outside the lumen through an opening 640 in the external tracheostomy tube 634. Channel 642 in tube 104 connects to a flushing line (not shown) and is adjacent to region 630 for providing flushing to the subglottic region outside the lumen through openings 644 and 646 in external tracheostomy tube 634. (As described above...) Figure 4 The actuation device allows the flushing fluid from supply / bottle 416 to be drawn through channel 642 to mix with secretions in the subglottic space outside the lumen, and then drawn out through channel 638 to terminate in the same or separate suction canister or vacuum source container 410. Other similar modifications and repositionings to the raised ridges and inlet defects on the inner cannula 632 and tube 104 used for subglottic suction are considered. Therefore, a new path for the flushing fluid flow is created, while still supplying suction and flushing to all the aforementioned orifices in the inner cannula for the purpose of intraluminal flushing.

[0083] Figure 6DAn embodiment of an intraluminal irrigation and aspiration cannula 648 for use with a perforated external tracheostomy tube 650 is shown. In certain clinical situations, a perforated external tracheostomy tube 650 may be required to assess breathing and speaking ability. The cannula 648 is compatible with this type of external tracheostomy tube design or a specially designed accompanying external tracheostomy tube. The external tracheostomy tube 650 can be cuffed or uncuffed, as shown. A raised, solid, block-shaped platform 652 is created on the cannula 648 in the region of the perforation 654 of the external tracheostomy tube 650. The platform 652 is sized to adjoin the inner surface of the external tracheostomy tube 650. In this way, airflow into and out of the patient's airway and into the subglottic region is blocked, while irrigation and aspiration can still be provided using the ridge 112 and regions 124 and 126, as described above. This blockage is sometimes necessary.

[0084] Optionally, sometimes it is necessary for air to flow into and out of the patient's airway through perforations in the external tracheostomy tube that enters and exits the subglottic region. To address this issue, Figure 6E The alternative embodiment shown is considered for use in a perforated external tracheostomy tube, which allows air to pass through perforation 654. Figure 6E In this embodiment, the intraluminal cannula 656 includes a generally circular or oval-shaped ridge 658 of the same area and shape as the overlapping perforation 654 on the external tracheostomy tube 650. In this embodiment, an accompanying opening within the ridge 658 into the luminal space within the intraluminal cannula 656 is intentional.

[0085] Figures 6A-6E None of the implementation schemes described herein compromise the flushing or suction function of the intraluminal space.

[0086] Active use of the System 400 reduces aerosolized airway particles because it is a closed system when used with a ventilator or tracheostomy tube filter, or a near-closed system when used without those. In either case, this reduces the risk of respiratory aerosols and particles, as well as infection in others, which is an inherent risk of standard tracheostomy care.

[0087] In the event of a malfunction, or for routine care, the internal cannula 100 can be released, removed, discarded, and replaced with a new cannula without needing to replace the external tracheostomy tube. Routine catheter-based endovascular aspiration can be performed with or without the internal cannula 100 in place.

[0088] Various modifications can be made to the cannula 100 or system 200. For example, additional ridges can be used on tube 102 to create additional areas, or chambers / catheters for monitoring devices and / or drug delivery. Ribs 112 on tube 102 can be reconfigured for different modes and subsequently different shapes of flushing and vacuum chambers, which can alter their function. Similarly, channels in tube 104 can be reconfigured for different modes or shapes to allow for flushing functionality in the aspiration chamber. Ribs 112 can allow communication between the patient's airway and the external environment for use with airway monitoring devices and / or measurements, or for drug delivery (droplets, aerosols, etc.).

[0089] The external tracheostomy tube 202 may be configured with grooves or reliefs to facilitate insertion, different or improved functionality, or cleanliness. The location, size, pattern, and shape of the holes and / or grooves on the tube 102 can be reconfigured for different fluid flow and suction performance. In embodiments, the internal cannula 100 may be extended (beyond the tip of the external tracheostomy tube 202) or shortened (into the lumen of 202) to further enhance operability.

[0090] The tubing used for flushing and aspiration can be modified by varying the position, diameter, length, and connection method of the rigid plastic lumen of this invention to achieve the same aspiration. The shape and configuration of the retainer, the lumen and ridge dimensions, the length, and the existing perforations can be applied to work with different existing tracheostomy tubes that are different in some or all of these respects.

[0091] An intraluminal aspiration cannulation system can be used in other applications or technical fields where frequent replacement of the cannula's lumen is required due to the accumulation of debris, secretions, or other substances; or, in situations where a replaceable lumen / cannula is not available, but where such a system can be beneficial in preventing blockages that would currently be manageable by aspiration from an intraluminal catheter. This may be in medical or non-medical settings.

[0092] In healthcare settings, endoluminal flushing and aspiration cannulation systems can be used with other medical devices / implanted tubes connected to the external environment—such as endotracheal tubes, nasotracheal tubes, gastrostomy tubes, colostomy tubes, or nephrostomy tubes, intraperitoneal lumens, surgical drainage, or other such applications in healthcare. Endoluminal flushing and aspiration cannulation systems can be used in many different settings, including inpatient and mobile / portable settings.

[0093] This function of the flushing lumen aspiration endovascular cannulation system can be directed to or performed by a computer, machine, or other electronic device that monitors and / or actuates the function.

[0094] The flushing lumen aspiration endovascular cannulation system and its described, implied, or derived uses may produce compositions that may have usefulness or value. Monitoring of secretions produced by its use may have diagnostic use for healthcare providers. It can also provide testing for the presence of certain pathogens in the secretions that can be detected or cultured without the need for additional instruments introduced into the patient's airway, thereby reducing the risk from additional procedures.

[0095] Health outcome data obtained from any periodic or automated application of endovascular flushing and aspiration cannulation systems, with or without mechanical or electronic control, can be useful in creating patient care protocols, reducing patient morbidity and / or mortality, and developing patient care algorithms. Improved airway hygiene, which is an recognized standard of care in tracheostomy patients, can improve patient health outcomes.

[0096] The functionality of the flushing lumen aspiration cannulation system requires only proper securing and connection to a flushing fluid or other flushing liquid source and a negative pressure (vacuum) source. Enhanced safety and comfort can be achieved through braking control of flushing and aspiration.

[0097] Modifications may be made to the methods and systems described above without departing from the scope of the invention. Therefore, it should be noted that the content contained in the above description or the accompanying drawings should be interpreted illustratively and not restrictively. In this document, and unless otherwise stated: (a) the adjective “exemplary” means used as an example, illustration, or description, and (b) the phrase “in an embodiment” is equivalent to the phrase “in some embodiments” and does not refer to all embodiments. The following claims are intended to cover all general and specific features described herein, as well as all statements regarding the scope of the methods and systems of the invention, and linguistically speaking, they fall within it.

[0098] Those skilled in the art can rearrange the position or size of the perforations / configuration / ridges / volume / shape of the flushing fluid and aspiration chambers, taking into account alternative configurations for various intended functions that are still within the scope of the principles discussed herein.

[0099] Combination of features

[0100] Without departing from the scope of this invention, the above-described features and those claimed below can be combined in various ways. The following examples illustrate some possible non-limiting combinations:

[0101] (A1) An endotracheal tube for use with a tracheostomy tube, comprising a first tube having a first diameter for insertion into the tracheostomy tube, the first tube further comprising a plurality of holes between a lumen space of the first tube and an outer surface of the first tube, and one or more ridges on the outer surface of the first tube dividing an air gap around the outer surface into a plurality of regions; and a second tube fused to the distal end of the first tube and having a second diameter greater than the first diameter, the second tube comprising a first channel between the outer surface of the second tube and a first region of the plurality of regions, and a second channel between the outer surface of the second tube and a second region of the plurality of regions.

[0102] (A2) In the endotracheal tube of (A1), the second tube further includes a retaining clip for attaching the endotracheal tube to the tracheostomy tube. (A3) In the endotracheal tube of (A1) or (A2), the first channel extends between the first region and the outer surface of the second tube and is connectable to a line coupled to a flushing source.

[0103] (A4) In the inner tube of (A1)-(A3), the second channel extends between the second region and the outer surface of the second tube and is connected to a line coupled to a vacuum source.

[0104] (B1) An intraluminal flushing and aspiration cannula system comprising an external tracheostomy tube; (A1) an intraluminal cannula; a flushing line attached to a first channel in the second tube and communicating with the first region; an aspiration line attached to a second channel in the second tube and communicating with the second region; and an actuation device coupled between the flushing line and a flushing source and between the aspiration line and a vacuum source, the actuation device controllably connecting the flushing line to the flushing source and the aspiration line to the vacuum source.

[0105] (B2) In the intubation system (B1), the external tracheostomy tube further includes a notch on its inner surface that is in the same pattern as the one or more ridges, such that when the internal cannula is inserted into the external tracheostomy tube, the one or more ridges engage with the notch.

[0106] (B3) In the cannulation system (B1) or (B2), the actuation device may be coupled only between the suction line and the internal cannula.

[0107] (B4) In any one of (B1)-(B3) intubation systems, the actuation device may be integrated into the ventilator.

[0108] (B5) In any one of (B1)-(B4) of the cannulation system, the flushing source is positioned at a distance below the vertical height of the inner cannula to prevent spontaneous flow.

[0109] (B6) In the cannulation system (B5), it also includes a flow sensor for monitoring excessive or unwanted flow of flushing fluid or aspiration.

[0110] (B7) In the cannulation system (B6), it also includes valves, flow limiters, mechanical flow and pressure sensors or current and pressure sensors.

[0111] (B8) In the cannulation system (B7), it also includes an alarm or notification when an excessive or unwanted flow of flushing fluid or aspiration is detected.

[0112] (B9) In any one of (B1)-(B8) of the intubation system, wherein the second tube further includes a retaining clamp for attaching the second tube to the external tracheostomy tube.

[0113] (B10) In any one of (B1)-(B9) intubation systems, wherein the external tracheostomy tube and the internal intubation tube form a single device.

[0114] (B11) In any one of (B1)-(B10) intubation systems, the external tracheostomy tube is a cuffed or uncuffed tracheostomy tube.

[0115] (B12) In any one of (B1)-(B11) intubation systems, the external tracheostomy tube is a perforated or non-perforated tracheostomy tube.

[0116] (B13) A method for cleaning the lumen space of a tracheostomy system, which is performed using any one of (B1)-(B12) a flushing lumen aspiration endotracheal tube system, the tracheostomy system comprising an external tracheostomy tube and an endotracheal tube inserted into the external tracheostomy tube.

[0117] (C1) An intraluminal and extraluminal aspiration cannulation system, comprising: an external tracheostomy tube including one or more openings along its length; an intraluminal cannula positioned within the external tracheostomy tube, comprising: a first tube having a length and diameter for insertion into the external tracheostomy tube, the first tube further comprising a plurality of openings between a luminal space of the first tube and an outer surface of the first tube, a first ridge dividing the outer surface of the first tube into a flushing region and a first aspiration region, and a second ridge creating a second aspiration region on the outer surface of the first tube; and a second tube fused to the distal end of the first tube and having a diameter greater than that of the first tube; and a flushing line attached to a flushing passage in the second tube and connected to the outer surface of the first tube and the... The system comprises: an air gap formed between the inner surfaces of the external tracheostomy tube in the flushing area; a first suction line attached to a first suction channel in the second tube and communicating with the air gap formed between the outer surface of the first tube and the inner surface of the external tracheostomy tube in the first suction area; a second suction line attached to a second suction channel in the second tube and communicating with the air gap formed between the outer surface of the first tube and the inner surface of the external tracheostomy tube in the second suction area; and an actuation device coupled between the flushing lines and a flushing source, and coupled between the first and second suction lines and a vacuum source, the actuation device controllably connecting the flushing lines to the flushing source and connecting the first and second suction lines to the vacuum source.

[0118] (C2) In the intubation system described in (C1), the first tube further includes a third ridge parallel to the second ridge, which divides the second aspiration region into an external flushing region and an external aspiration region, wherein the second aspiration channel communicates with the external aspiration region, and the internal cannula further includes a second flushing line attached to the second flushing channel in the second tube and communicating with an air gap formed between the outer surface of the first tube and the inner surface of the external tracheostomy tube in the external aspiration region.

[0119] (C3) A method for cleaning the extraluminal / subglottic space of a tracheostomy system, which is performed using any one of (C1)-(C3) of flushing intraluminal aspiration and extraluminal aspiration intracannulation system, the tracheostomy system comprising an external tracheostomy tube and an intracannulation tube inserted into the external tracheostomy tube.

[0120] (D4) A method for cleaning a tracheostomy tube including an external tracheostomy tube and an internal cannula, the internal cannula including a plurality of orifices and one or more ridges, the ridges dividing an air gap between the external tracheostomy tube and the internal cannula into a plurality of regions when the internal cannula is inserted into the external tracheostomy tube, the method comprising: attaching an aspiration line to the internal cannula such that it communicates with a first region among the plurality of regions; attaching an actuation device between the aspiration line and a vacuum source, the actuation device controllably connecting the aspiration line to the vacuum source; and controlling the actuation device to aspirate from the lumen of the internal cannula through a first portion of the plurality of orifices, the first region, and the aspiration line.

[0121] (D2) In the method described in (D4), it further includes: attaching a flushing line to the insert tube such that it is in communication with a second region in the plurality of regions; attaching the actuation device between the flushing line and the flushing source, the actuation device controllably connecting the flushing line to the flushing source; and controlling the actuation device to provide flushing to the lumen of the insert tube through a second portion of the plurality of holes, the second region, and the flushing line.

Claims

1. An internal cannula (100) for use with a tracheostomy tube, comprising: A first tube (102) having a first diameter, a distal end, and a proximal end for insertion into the tracheostomy tube, the first tube further including a plurality of holes (125, 127) between a lumen space of the first tube and an outer surface of the first tube, and a continuously rising ridge (112) on the outer surface of the first tube, the continuously rising ridge (112) having a height adjacent to the lumen of the tracheostomy tube, wherein the continuously rising ridge extends along a first length of the first tube at least in the proximal direction, around a circumference (116) of the first tube, and along a second length of the first tube in the distal direction, the continuously rising ridge dividing an air gap around the outer surface into a plurality of separate regions, the separate regions including at least a first region (124) and a second region (126); and A second tube (104) is fused to the distal end of the first tube and has a second diameter greater than the first diameter. The second tube includes a first channel (128) between the outer surface of the second tube and the first region (124), and a second channel (130) between the outer surface of the second tube (104) and the second region (126).

2. The endotracheal tube of claim 1, wherein the second tube further comprises a retaining clip for attaching the endotracheal tube to the tracheostomy tube.

3. A flushing and aspiration system for the inserted cannula, comprising: External tracheostomy tube (202); The internal cannula of claim 1, positioned within the external tracheostomy tube; A flushing line (306) is attached to a first channel (128) in the second pipe (104) and communicates with the first region (124); A suction line (302) is attached to a second channel (130) in the second tube (104) and communicates with the second region (126); and An actuation device (404) is coupled between the flushing line (306) and the flushing source (416) and between the suction line (302) and the vacuum source (411), the actuation device controllably connecting the flushing line to the flushing source and the suction line to the vacuum source.

4. The intubation system of claim 3, wherein the external tracheostomy tube further includes a notch on its inner surface that is in the same pattern as one or more ridges, such that when the internal cannula is inserted into the external tracheostomy tube, the one or more ridges engage with the notch.

5. The cannulation system of claim 3, wherein the actuation device is coupled only between the suction line and the internal cannula.

6. The intubation system of claim 3, wherein the actuation device is integrated into the ventilator.

7. The cannulation system of claim 3, wherein the flushing source is positioned at a distance below the vertical height of the inner cannula to prevent spontaneous flow.

8. The cannulation system of claim 7, further comprising a flow sensor for monitoring excessive or unwanted flow of flushing fluid or aspiration.

9. The cannulation system of claim 8, further comprising a valve, a flow limiter, a mechanical flow and pressure sensor, a current and pressure sensor; or an alarm or notification when an excessive or unwanted flow of flushing fluid or aspiration is detected.

10. The intubation system of claim 3, wherein the external tracheostomy tube and the internal intubation tube form a single device.

11. The intubation system of claim 3, wherein the external tracheostomy tube is a cuffed, non-cuffed, perforated, or non-perforated tracheostomy tube.

12. The endotracheal tube system of claim 3, wherein the external tracheostomy tube includes one or more openings (640, 654) along its length.

Images