Irrigation cannula system

Abstract

An irrigated endoluminal aspiration inner cannula system for a tracheostomy tube may be an aspiration drive system that may be used alone for aspiration, or in combination with irrigation and endoluminal aspiration for a tracheostomy tube, instead of traditional catheter endoluminal aspiration. The inner cannula includes a plurality of chambers (or regions) and apertures that facilitate intraluminal aspiration and cleaning at a plurality of locations within the tracheotomy tube. The system can be operated / driven by a patient, a medical person, a caregiver or on demand, at regular or at trigger intervals through an electronic system in a hospitalization / hospital or outpatient / daytime care environment.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Application No. 18 / 128,918, filed March 30, 2023, which is a continuation-in-part of U.S. Application No. 17 / 643,816, filed December 10, 2021, which in turn claims priority to U.S. Provisional Patent Application No. 63 / 124,599, filed December 11, 2020. All of the above applications are hereby incorporated herein by reference in their entirety. Background Technology

[0002] Endotracheal intubation is the procedure of inserting an endotracheal breathing tube into a patient's airway, with the distal end positioned within the trachea. The tube can be inserted through the mouth, nose, or via a tracheostomy (a method of insertion through the skin and soft tissue of the neck), ultimately ending in the trachea. These procedures are performed to provide temporary or permanent support for breathing or ventilation. The risks and problems associated with the insertion, use, and care of endotracheal breathing tubes range from causing discomfort and inconvenience to leading to serious medical risks and adverse health consequences.

[0003] Tracheostomy tube care requires regular clearing of secretions from the innermost part of the tube (i.e., the "inner lumen") to ensure safe use and comfort. In some cases, this may need to be done every 30 minutes. Even without sedation, few patients are able to perform effective, safe, and regular endotracheal suctioning without assistance, thus relying on others to complete this crucial procedure, which often leads to depression, anxiety, and agitation. Even with assistance, patients frequently experience discomfort during suctioning. There are two reasons for this: first, frequent misuse of the suction catheter (i.e., the suction catheter being inserted too deeply / too close to the airway); second, the patient's inability to apply suction (negative pressure) at the appropriate time during the respiratory cycle, resulting in "accidental" suctioning, which in turn causes shortness of breath, changes in airway pressure, and triggers a cough reflex.

[0004] Figures 7A to 7C This illustrates the basic anatomical structure of the endotracheal tube and several aspects of the features of existing tracheostomy tubes. Figure 7A This is a side sectional view of patient 700, which shows various types of endotracheal tubes. Figure 7B It is a perspective view of a tracheostomy tube with an inner sleeve, and Figure 7C This is a perspective view of the tracheostomy tube and inner sleeve with a window. In the following discussion, it is best to... Figures 7A to 7C Please refer to both sources.

[0005] Patient 700's trachea 702 is part of the airway leading to patient 700's lungs (not shown). To support breathing, patient 700 can... Figure 7AThe diagram illustrates several methods for endotracheal intubation. Intubation can be achieved via a longer nasotracheal tube via path 704, which is inserted through the nasal cavity, across the vocal cords 710, and into the trachea 702. Alternatively, a similarly long oral endotracheal tube via path 706 can be inserted through the oral cavity and into the trachea 702. Furthermore, a shorter tracheostomy tube 708 can be directly inserted into the trachea 702 at region 712 via surgical tracheostomy.

[0006] During positive pressure ventilation or mechanical ventilation, the inflatable cuff 714 surrounding the tracheostomy tube 708 can be inflated via the cuff inflation valve 716, the external monitoring balloon 718, and related tubing 720 to form a seal between the tracheostomy tube 708 and the trachea 702, preventing gas leakage around the tube. This type of catheter is called a "cuffed" catheter. The cuff 714 can be inflated or deflated according to the patient's needs. For example, as... Figure 7C As shown, similar catheters without this cuff are called "cuffless" catheters.

[0007] like Figure 7B As shown, the tracheostomy tube 708 includes a flange 722, which is positioned against the neck of the patient 700 to hold the tracheostomy tube 708 in the correct position and perform its specific function. A removable inner cannula 724 is an additional feature of some prior art tracheostomy tubes and can be used with cuffed or cuffless tracheostomy tubes. Gas exchange with the patient 700 is conducted via interface 726 through the innermost lumen of the tracheostomy tube 708 (or, if the inner cannula 724 is present, through the inside or lumen of the inner cannula 724). The interface 726 of the inner cannula 724 includes a snap-fit ​​728 that engages with a snap-fit ​​connector 730 on the flange 722.

[0008] Figure 7C The principle of a tracheostomy tube with a window is illustrated. A window 732 is included in the tracheostomy tube 708 above the region 734 where the inflatable cuff is located. If an inner cannula 724 is used, a corresponding window 736 may also be included in the inner cannula 724. Windows 732 and 736 allow airflow, thereby enabling the patient 700 to speak and cough more effectively. The methods, concepts, and designs applied to and described in this article for tracheostomy tubes can also be applied to nasotracheal tubes and orotracheal tubes.

[0009] Most existing secretion management procedures use only suction to clear secretions from the tracheostomy tube. Currently, there is no safe method to flush the inner lumen of the tracheostomy tube to prevent secretion buildup, blockage, and sudden airway obstruction. Therefore, due to inadequate clearance of the tracheostomy tube, patients may require higher-level interventions or additional surgical procedures.

[0010] Existing techniques for clearing secretions from the tracheostomy lumen via manual suction catheters can also pose risks of infection to patients and frequently result in airway injury. This can also lead to significant psychosocial distress for patients and caregivers, loss of patient autonomy, strain on healthcare resources, and increased workload for nursing staff, all of whom may be exposed to airborne pathogens expelled from the patient's airway. Because such secretion clearance procedures need to be performed frequently, this further increases the time and resource burden on healthcare and / or nursing staff and places patients in a passive position regarding their own care.

[0011] Currently available tracheostomy tubes with flushing and / or suction functions only act on a single area within the airway (i.e., subglottic / "above the cuff" or proximal tip), and most commonly do not act on the interior of the lumen. Devices capable of clearing secretions from the lumen cannot handle the distal tip or extraluminal portion and lack flushing capabilities, thus easily leading to sudden airway obstruction due to blockage. These devices have not gained widespread clinical acceptance; therefore, obstruction / airway blockage, infection, and the various drawbacks of standard manual endotracheal suction systems remain major problems in tracheostomy tube care. Furthermore, malfunctions or blockages in these designs often require removal of the entire tracheostomy tube, which can be dangerous. Summary of the Invention

[0012] An irrigation cannula system for tracheostomy tubes may be a suction-driven system that can be used alone for suction, or in combination with irrigation and endoluminal suction for tracheostomy tubes, as an alternative to conventional catheter-based endoluminal suction. The inner cannula includes multiple chambers (or areas) and orifices that facilitate endoluminal suction and cleaning at multiple locations within the tracheostomy tube. The system can be operated / driven by patients, healthcare professionals, or caregivers in inpatient / hospital or outpatient / day care settings, or driven on demand, periodically, or at trigger intervals via an electronic system.

[0013] In a first aspect, an inner cannula for a tracheostomy tube includes: a first conduit having a first diameter for insertion of the tracheostomy tube, the first conduit further including a plurality of holes and one or more ridges located between a lumen space of the first conduit and an outer surface of the first conduit, the ridges located on the outer surface of the first conduit dividing an air space around the outer surface into a plurality of regions; and a second conduit fused to a distal end of the first conduit and having a second diameter greater than the first diameter, the second conduit including a first channel and a second channel, the first channel being located between the outer surface of the second conduit and a first region of the plurality of regions, the second channel being located between the outer surface of the second conduit and a second region of the plurality of regions.

[0014] In a second aspect, a flushing cannula system includes: an outer tracheostomy tube; and an inner cannula located inside the outer tracheostomy tube. The inner cannula includes: a first conduit having a first diameter for insertion into the outer tracheostomy tube, the first conduit further including a plurality of orifices and one or more ridges located between a lumen space of the first conduit and an outer surface of the first conduit, the ridges located on the outer surface dividing an air space between the outer surface of the inner cannula and the inner surface of the outer tracheostomy tube into a plurality of regions; and a second conduit fused to a distal end of the first conduit and having a second diameter greater than the first diameter, the second conduit including a first channel and a second channel, the first channel being located between the outer surface of the second conduit and a first region within the plurality of regions, and the second channel being located between the outer surface of the second conduit and a second region within the plurality of regions. The system also includes: a flushing fluid line connected to a first channel in a second conduit and communicating with a first region; a suction line connected to a second channel in the second conduit and communicating with a second region; and a drive device coupled between the flushing fluid line and a flushing fluid source, and coupled between the suction line and a vacuum source, the drive device controllingly connecting the flushing fluid line to the flushing fluid source and the suction line to the vacuum source.

[0015] In a third aspect, a flushing cannula system includes: an outer tracheostomy tube including one or more openings along its length; and an inner cannula located inside the outer tracheostomy tube, the inner cannula including: a first conduit having a length and diameter for insertion into the outer tracheostomy tube, the first conduit further including a plurality of openings, a first ridge and a second ridge, the openings being located between a lumen space of the first conduit and an outer surface of the first conduit, the first ridge dividing the outer surface of the first conduit into a flushing region and a first suction region, the second ridge forming a second suction region on the outer surface of the first conduit, and a second conduit fused to a distal end of the first conduit and having a diameter greater than that of the first conduit. The system further includes: a flushing fluid line connected to a flushing channel in a second conduit and communicating with an air space formed between the outer surface of the first conduit and the inner surface of the outer tracheotomy tube within the flushing area; a first suction line connected to a first suction channel in the second conduit and communicating with an air space formed between the outer surface of the first conduit and the inner surface of the outer tracheotomy tube within the first suction area; a second suction line connected to a second suction channel in the second conduit and communicating with an air space formed between the outer surface of the first conduit and the inner surface of the outer tracheotomy tube within the second suction area; and a drive device coupled between the flushing fluid line and a flushing fluid source and coupled between the first and second suction lines and a vacuum source, the drive device controllingably connecting the flushing fluid line to the flushing fluid source and connecting the first and second suction lines to the vacuum source.

[0016] In another aspect, a method for cleaning a tracheostomy tube having an outer tracheostomy tube and an inner sleeve, the inner sleeve including a plurality of holes and one or more ridges that, when the inner sleeve is inserted into the outer tracheostomy tube, divide the air space between the outer tracheostomy tube and the inner sleeve into a plurality of regions, the method comprising: connecting a suction line to the inner sleeve such that it communicates with a first region among the plurality of regions; connecting a drive device between the suction line and a vacuum source, the drive device controllingly connecting the suction line to the vacuum source; and controlling the drive device to suction from the lumen of the inner sleeve through a first portion of the plurality of holes, a first region, and the suction line.

[0017] In addition, the method may further include: connecting a flushing fluid line to an inner sleeve such that it communicates with a second region in a plurality of regions; connecting a drive device between the flushing fluid line and a flushing fluid source, the drive device controllingly connecting the flushing fluid line to the flushing fluid source; and controlling the drive device to supply flushing fluid to the lumen of the inner sleeve through the second portion of the plurality of holes, the second region, and the flushing fluid line.

[0018] If needed or desired, the use of this flushing cannula system does not preclude the use of currently standard catheter-type intraluminal aspiration. The use of this flushing cannula system also does not limit the use of existing subglottic extraluminal (e.g., subglottic) aspiration systems, and these designs can be integrated.

[0019] If the performance of the flushing cannula system is not optimal, the inner cannula can be removed and replaced without removing the tracheostomy tube. Finally, in certain situations (e.g., when connected to mechanical ventilation or when using an external filter or other similar cap to restrict secretions), the flushing cannula system can simultaneously perform flushing and suction within a “closed system,” thereby reducing or eliminating potentially infectious aerosols and / or particles generated by suction in existing “open” tracheostomy tubes, thus reducing the risk of exposure to airborne pathogens for healthcare workers and caregivers.

[0020] The embodiments of the irrigation cannula system disclosed herein solve these problems through their novel design and application in closed systems, as detailed below. For example, by creating separate chambers for suction and irrigation within the tracheostomy tube, this irrigation cannula system achieves intra-tracheostomy suction and irrigation functions that are not currently available. Therefore, it avoids the defects and risks of the prior art. Attached Figure Description

[0021] Figure 1A This is a side view of the flushing lumen suction inner sleeve in the embodiment.

[0022] Figure 1B yes Figure 1A A perspective view of the sleeve.

[0023] Figure 1C yes Figure 1A Top view of the casing.

[0024] Figure 1D yes Figure 1A A bottom view of the casing.

[0025] Figure 1E yes Figure 1A A cross-sectional view of the inner sleeve.

[0026] Figure 2A This is a cross-sectional side view of the flushing lumen suction sleeve with an outer lumen in the embodiment.

[0027] Figure 2B yes Figure 2A A perspective view of the casing system.

[0028] Figure 2C yes Figure 2A An enlarged view of a portion of the casing system.

[0029] Figure 3 This is a side view of the sleeve with flushing fluid and suction connector in the embodiment.

[0030] Figure 4 The embodiment is a flushing lumen suction inner sleeve system.

[0031] Figure 5 This is a flowchart illustrating a method for using a flushing lumen suction inner sleeve system.

[0032] Figure 6A This is a perspective view of the flushing-type intraluminal suction cannula system and its matching cuffed outer tracheostomy tube, which integrates additional extra-luminal subglottic suction function in the embodiment.

[0033] Figure 6B This is a perspective view of another flushing intraluminal suction cannula system that integrates additional extra-luminal subglottic suction function and a matching cuffed outer tracheostomy tube, as described in the embodiment.

[0034] Figure 6C This is a perspective view of the flushing-type intraluminal suction inner cannula system that integrates flushing and suction functions in the subglottic region outside the lumen, as well as the matching dedicated cuffed outer tracheostomy tube, as described in the embodiment.

[0035] Figures 6D to 6E This is a perspective view of the flushing-type intraluminal suction inner sleeve system for an outer tracheotomy tube with a window opening, as described in the embodiment.

[0036] Figure 7A This is a side sectional view of various prior art endotracheal tubes in the patient's body, as shown in the embodiments.

[0037] Figure 7B This is a perspective view of a prior art tracheostomy tube with an inner sheath in the embodiment.

[0038] Figure 7C This is a perspective view of the prior art tracheotomy tube with window and inner sleeve in the embodiment.

[0039] Figure 8 This is a right front perspective view of the flushing sleeve system in another embodiment.

[0040] Figure 9 yes Figure 8 Right rear perspective view of the casing system.

[0041] Figure 10 yes Figure 8 The front view of the casing system.

[0042] Figure 10A yes Figure 10 A side sectional view of the casing system along line 10A-10A.

[0043] Figure 10B yes Figure 10 A cross-sectional view of the casing system along line 10B-10B.

[0044] Figure 10C yes Figure 10 A cross-sectional view of the casing system along line 10C-10C.

[0045] Figure 11-12 They are Figure 8 Right and left views of the casing system.

[0046] Figure 13 This is used in the embodiments Figure 8 A perspective view of the flushing inner casing of the casing system.

[0047] Figure 14 yes Figure 13 Side view of the inner sleeve.

[0048] Figure 14A , Figure 14B and Figure 14C yes Figure 14 A cross-sectional view of the inner sleeve.

[0049] Figure 15 yes Figure 13 The front view of the inner sleeve.

[0050] Figure 16 This is a right front perspective view of the outer sleeve with cleaning features in the embodiment.

[0051] Figure 17 yes Figure 16 Side view of the outer tube.

[0052] Figure 18 yes Figure 16 The front view of the outer tube.

[0053] Figure 19 yes Figure 18 A sectional view of the outer tube along line 19-19.

[0054] Figure 19A yes Figure 19 The exploded diagram. Detailed Implementation

[0055] The principles of this disclosure may have specific applications in tracheostomy tubes, and therefore will be described primarily in this context below. However, it should be understood that the principles and aspects of this disclosure can also be applied to endotracheal tubes via the mouth or nose, or other flushing and suction tubes used in healthcare or industrial fields.

[0056] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description refers to the drawings, the same numerals in different drawings denote the same or similar elements unless otherwise stated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses and methods consistent with certain aspects of this disclosure described in detail in the appended claims.

[0057] In the above and following discussion, the term "proximal" is used to indicate a direction closer to the patient's lung and / or the tip of the tracheostomy tube on the lung side. The term "distal" is used to indicate a direction farther from the patient and / or toward the patient's external equipment or the outer end of the tracheostomy tube. Other terms used herein are defined as follows.

[0058] Cannula - A catheter inserted into a body cavity, duct, or blood vessel.

[0059] Lumen - The space inside the casing.

[0060] Intraluminal - located in the innermost lumen between the two ends of the sleeve.

[0061] Annular space - the area between the inner sleeve and the outer sleeve.

[0062] Extraluminal – Located outside the cannula or at one or both ends of the cannula. In this document, “extraluminal” applies to the outermost catheter or either end of the catheter / cannula in any situation.

[0063] Subglottic – usually refers to the area located below the glottis. In this article, “subglottic” refers to the extraluminal region of the trachea located above the inflatable cuff of the endotracheal tube and below the vocal cords.

[0064] The innermost airway lumen of an endotracheal tube (including a tracheostomy tube) ranges in diameter from 2 mm for neonatal tubes to approximately 14 mm for adult tubes, with its lower limit constrained by the effective airflow / ventilation volume to 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 fit through the vocal cords / glottis into the trachea), typically limiting the upper limit to approximately 15 mm.

[0065] The flushing-type endotracheal suction cannula system discussed in this article typically includes a tracheostomy tube and an inner cannula. The inner cannula is inserted into the tracheostomy tube, simultaneously enabling suction and flushing of the tracheostomy tube. Figures 1A to 1D The inner sleeve 100 in the embodiment is shown, while Figures 2A to 2C The inner cannula 100 shown in the embodiment is combined with a tracheostomy tube to form a flushing intraluminal suction inner cannula system 200.

[0066] Figure 1A A side view of the inner sleeve 100 with lumen suction and flushing functions is shown in the embodiment. Figure 1B , Figure 1C and Figure 1D The oblique view, top view, and bottom view of the inner sleeve 100 are shown respectively. Figure 1E yes Figure 1A A sectional view along line 1E-1E. In the following description, it is best to refer to... Figure 1A-1E Let's take a look together.

[0067] The inner cannula 100 includes: a single, curved, semi-rigid plastic first catheter 102, which is fused to a rigid plastic second catheter 104. The inner cannula 100 can be inserted into the patient's existing tracheostomy tube 202 (e.g., Figures 2A to 2C (As shown) or inserted into a tracheostomy tube specifically designed for use with the inner cannula 100. The outer tracheostomy tube 202 may or may not be equipped with a balloon cuff known in the art for positive pressure ventilation (such as 6A to Figure 6D The cuff 604 in the figure (i.e., a "cuffed" or "cuffless" tracheostomy tube). The inner cannula 100 can be secured to the patient's existing tracheostomy tube 202 or a matching dedicated tracheostomy tube using appropriate fasteners 106. Depending on the patient's needs or its use in the endotracheal tube, the inner cannula 100 can have various diameters, thicknesses, and lengths. In this embodiment, the diameter of the semi-rigid plastic first catheter 102 is smaller than the diameter of the rigid plastic second catheter 104. An intraluminal space 132 is formed throughout the inner cannula 100.

[0068] The inner cannula 100 includes continuous raised ridges 112 on the outer surface of the first conduit 102. The arrangement and height of the ridges 112 are designed to abut against the inner lumen of the rigid outer tracheostomy tube 202. The width of the ridges 112 is set relative to the circumference of the inner cannula 100 to divide the outer surface of the first conduit 102 into multiple regions 124, 126, or chambers. Starting from point 114 where the first conduit 102 and the second conduit 104 are fused, the ridges 112 extend proximally along the length of the first conduit 102, at which point the width of the ridges 112 is measured circumferentially. At point 116, the ridges 112 bend such that the width of the ridges 112 is parallel to the length of the inner cannula 100. Subsequently, the ridges 112 bend again such that the width of the ridges 112 is measured circumferentially and extends distally along the first conduit 102. Before reaching the second conduit 104, the ridge 112 extends again around the circumference of the first conduit 102 at point 118, extending in the proximal direction to point 120, and then extends upward along the first conduit 102 again, finally terminating at point 122 where the first conduit 102 and the second conduit 104 are fused.

[0069] Regions 124 and 126 of the first conduit 102 formed by the ridge 112 each include a series of openings between the outer surface and the lumen space 132 to allow air and / or liquid flow. Region 124 includes orifices 125 and is located on both sides of the first conduit 102, while region 126 includes grooves 127 and is located at the top and bottom of the first conduit 102. Although orifices and grooves are shown in the figures, this is only an example. In embodiments, the positions of orifices and grooves may be interchanged. Furthermore, all openings may be grooves or orifices, or orifices 125 and grooves 127 may have different sizes or other shapes to perform their functions. Similarly, Figures 1A to 1E The shape and orientation of the ridges shown are merely examples and can be configured differently to achieve the functionality described herein.

[0070] In this embodiment, the rigid plastic second conduit 104 includes a first channel 128 and a second channel 130, both located at a 90-degree angle to the fixing clip 106, but they can also be located in other positions, as long as the first channel 128 and the second channel 130 are connected to regions 124 and 126 respectively. The first channel 128 and the second channel 130 can be slots or closed channels passing through the second conduit 104. The first channel 128 extends at an angle from the upper outer surface of the second conduit 104 to an opening near the proximal end of the second conduit 104 close to the first conduit 102. In this embodiment, the first channel 128 communicates with the air space (located within region 124) formed by the ridge 112 between the abutting inner surfaces of the first conduit 102 and the outer tracheostomy tube 202. The orifice 125 forms a communication between the air space in region 124 and the lumen space 132. Similarly, the second channel 130 extends at an angle from the lower outer surface of the second conduit 104 (opposite to the first channel 128) to an opening near the proximal end of the second conduit 104 close to the first conduit 102, but this opening is opposite to the opening of the first channel 128. In this embodiment, the second channel 130 also communicates with the air space formed by the ridge 112 between the abutting inner surfaces of the first conduit 102 and the outer tracheostomy tube 202, but this air space is located within region 126 rather than region 124. Region 126 includes a groove 127, which also forms a communication between the air space in region 126 and the intraluminal space 132.

[0071] Such as combination Figure 3 As will be discussed in more detail, flexible plastic tubing of different diameters, thicknesses, and lengths can be connected to the first channel 128 on the upper surface of the second conduit 104. As will be further discussed below, flexible plastic tubing of different diameters, thicknesses, and lengths can also be connected to the second channel 130 on the lower surface of the second conduit 104. The terms "upper surface" and "lower surface" are merely illustrative, and the first channel 128 and the second channel 130 can be located anywhere on the circumference of the second conduit 104.

[0072] Figures 2A to 2C The inner cannula 100 is shown inserted into the outer tracheostomy tube 202, forming a flushing lumen suction inner cannula system 200. Figures 2A to 2C Components not specifically described in the text are combined with the above. Figures 1A to 1E The components described are the same.

[0073] System 200 includes an outer tracheostomy tube 202, which can be a patient's existing tracheostomy tube or a tracheostomy tube specifically designed for use with the inner cannula 100. In embodiments, the dedicated outer tracheostomy tube 202 can be used in conjunction with the inner cannula 100 as a kit. For example, the outer tracheostomy tube 202 may have grooves on its inner surface that engage with ridges 112 and improve the function of the inner cannula 100. Figure 2A As shown, only a portion of the outer tracheostomy tube 202 is depicted. A portion of the outer tracheostomy tube 202 is cut open to show the engagement of the first conduit 102 and the ridge 112 with the inner surface of the outer tracheostomy tube 202. Furthermore, the outer tracheostomy tube 202 extends toward the second conduit 104 and is provided with a mechanism for engaging with the retaining clip 106. This mechanism can have various forms, and is omitted here for clarity. Figure 2B A system 200 with a complete outer tracheostomy tube 202 is shown.

[0074] like Figure 2B As shown, the length of the outer tracheostomy tube 202 is approximately equal to the length of the first conduit 102 of the inner cannula 100. The diameter of the outer tracheostomy tube 202 is chosen such that the ridge 112 abuts against the inner surface of the outer tracheostomy tube 202 at point 134, as shown, to form air spaces divided into regions 124 and 126. The end 136 of the first channel 128 in the second conduit 104 communicates with region 124, while the end 138 of the second channel 130 in the second conduit 104 communicates with region 126. Figure 1C and Figure 1D As shown more clearly, region 126 includes regions located on opposite sides of the first conduit 102. In an embodiment, ridge 112 may also be formed inside the outer tracheostomy tube 202, while still forming the aforementioned region or chamber. Alternatively, ridge 112 may be formed simultaneously on both the inner sheath 100 and the outer tracheostomy tube 202, forming a single, inseparable device.

[0075] During the procedure, the inner cannula 100 can be used to aspirate and clear secretions from the patient's tracheostomy tube. Secretions accumulate periodically and typically require endovascular aspiration, which is currently usually performed by a third party, and the secretions are often too viscous to be easily suctioned. The inner cannula 100 can be inserted into an existing tracheostomy tube or a dedicated matching tracheostomy tube. After being secured by the patient's existing tracheostomy tube (or matching tracheostomy tube) with the retaining clip 106, suction can be used alone, or in combination with irrigation, to clear secretions from the endovascular space and the adjacent end of the patient's tracheostomy tube. In embodiments, suction (or a combination of suction and irrigation) can also be applied to the subglottic region outside the lumen. Irrigation can be performed using an irrigation solution (e.g., normal saline). In embodiments, other solutions, such as mucolytics, antibiotics, antifungals, steroids, or other medications, can also be used. Combining flushing and suction can also flush the inner lumen of the tracheostomy tube and the suction chamber, thereby diluting (reducing viscosity) secretions, making them easier to suction and remove, preventing accumulation and blockage, and reducing the colonization burden of pathogenic microorganisms in the tube and airway tissues.

[0076] In the embodiments, combined with Figure 3 and Figure 4 The following description of the method of using any of the cannulas disclosed herein is best viewed in conjunction with these two figures. For illustrative purposes, the inner cannula 100 shown in the figures does not include the outer tracheostomy tube 202. The inner cannula 100 can be inserted with one of two types of tracheostomy tubes: a) the patient's existing tracheostomy tube; b) a dedicated matching tracheostomy tube—both options a and b are represented by the flushing endoluminal suction inner cannula system 200 disclosed herein. After being secured by the retaining clip 106 for the patient's existing tracheostomy tube or dedicated matching tracheostomy tube, the proximal end of the suction line 302 is received by the second channel 130. The suction line 302 may be a flexible plastic tube, the end of which is fused to a standard suction connector 304. The proximal end of the flushing fluid line 306 is received by the first channel 128. The flushing fluid line 306 may be a flexible plastic tube, the end of which is fused to a standard intravenous (IV) line connector 308 (e.g., a Luer lock). In the embodiment, the suction line 302 and the flushing fluid line 306 have a default / fail-safe off position, which can prevent: a) positive pressure loss (i.e. leakage) under mechanical ventilation; b) spontaneous flow of flushing fluid; and c) automatic suction by the device.

[0077] Figure 4A flushing-type intraluminal suction cannula 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 system 200 in use. The distal end of suction line 302 is connected to suction line inlet 402 on drive unit 404. Suction line 406 at the distal end of drive unit 404 is coupled to inlet 408 of vacuum source interface 410. Interface 410 can be connected to a continuous suction / negative pressure source, such as a hospital wall-mounted vacuum interface or a portable suction device.

[0078] Similarly, the flushing fluid line 306 from the inner cannula 100 is coupled to a corresponding flushing fluid line inlet 412 on the drive unit 404. The flushing fluid line 414 at the distal end of the drive unit 404 connects to the flushing fluid bottle 416 via a cap 418 with a straw extending to the bottom of the bottle. A vent 420 on the cap 418 can be opened for ease of use and to reduce resistance to flushing fluid flow, promoting flushing fluid flow. The flushing fluid bottle 416 must always be placed on the ground near the patient or maintained at least one foot below the vertical height of the patient's tracheostomy tube (or another defined distance to prevent gravity flow when the drive unit is open). In embodiments, the flushing fluid bottle 416 may be, for example, a ventilated flushing fluid bottle or a hanging bag attached to the patient's bed or a freestanding support.

[0079] when Figure 4 After all components are properly secured, the control drive 404 is activated by actuation of buttons 422 and 424 to perform either individual suction or a combination of suction and flushing. Individual suction actuation using button 424 draws air and secretions from the lumen space 132 of the inner cannula 100 through the region 126 formed by ridge 112 between the inner cannula 100 and the inner surface of the outer tracheostomy tube 202. Figure 2A The fluid flows to the distal end (as shown in Figure 2D) and through conduits 302 and 406, ultimately entering the vacuum source interface 410, thereby clearing secretions from the lumen. Although the drive unit 404 described herein has buttons, any mechanism capable of controlling the drive unit 404 and the active use system 400 to achieve the functions described herein can be employed. Additional buttons and functions may also be provided as part of the drive unit 404 and the active use system 400.

[0080] If both the suction button 424 and the flushing button 422 are actuated simultaneously, the flushing fluid from the distal flushing fluid bottle 416 will be drawn in through tubing 414 and 306 under the negative pressure applied by the suction lines 302 and 406. The flushing fluid is drawn into the region 124 formed by the ridge 112 between the inner surface of the inner sleeve 100 and the outer tracheotomy tube 202. The flushing fluid will enter the lumen space 132 of the inner sleeve 100 through the hole 125, mix with the air and secretions in the lumen, and then pass through the groove 127 ( Figures 1A to 1D The flushing fluid enters region 126. This flow of the flushing fluid will dilute the secretions and flush the lumen space 132 of the inner sleeve 100, eventually flowing into the vacuum source interface 410.

[0081] The drive unit 404 can be designed in various ways, as long as it has control buttons or other actuators and can establish a connection between the suction and flushing fluid lines of the tracheostomy cannula and the corresponding flushing fluid and suction sources. In an embodiment, the drive unit 404 includes buttons 422 and 424 that can be moved / pressed to an aligned position. More or fewer buttons may also be provided. The plastic housing of the drive unit 404 is shown as including an inlet 402 for the suction line 302 and an outlet on the opposite side for the line 406, which provides suction to the inner cannula 100. The plastic housing of the drive unit 404 also has an inlet 412 for the flushing fluid line 306 and an outlet on the opposite side for the flushing fluid line 414, which passes through a cap 418 into a standard flushing fluid bottle 416. These inlets and outlets can be located in any convenient position on the drive unit 404. The actuator 404 operates as follows: the lumens of tubing 302 and 406 align to allow fluid flow only when button 424 is pressed; otherwise, fluid flow is blocked when button 424 is not actuated. Similarly, the lumens of tubing 306 and 414 align to allow fluid flow only when button 422 is pressed. In this embodiment, the actuator 404 can prevent the flow of flushing fluid without the application of suction, but allows suction to be used alone. Other actuator mechanisms for connecting tubing 302, 306 to tubing 406, 414 may also be employed. Furthermore, the actuator may be provided as a component of other medical devices.

[0082] Patient protection is achieved by preventing the flow of irrigation fluid without suction using the drive device 404 and by ensuring that the irrigation fluid bottle 416 is always held at least one foot (or other defined distance below the vertical height of the tracheostomy tube to prevent spontaneous fluid flow) below the tracheostomy tube. In other words, the irrigation fluid bottle 416, along with the hanging bag or any device for delivering the irrigation fluid, must always be positioned below the vertical height of the tracheostomy tube in the absence of other irrigation fluid flow-limiting mechanisms. Other methods of controlling the flow of irrigation fluid may also be employed. For example, the irrigation fluid can be actively propelled in a continuous or pulsed manner through the same flow path described above by means of a pump or pressurized irrigation fluid canister using a variant of the drive device 404, rather than relying solely on the negative pressure generated by the vacuum source 411 for aspiration. This pump can be placed proximally or distally to the drive device. In an embodiment, the orifice 125 on the inner sleeve 100 may include a one-way valve or a pressure relief valve, such as a simple slit or notch in the material of the area, which remains closed in a baseline state and opens when the pressure in the flushing fluid line near the drive unit increases.

[0083] In this embodiment, the active use system 400 may include additional fault protection measures. In the event of a malfunction in flushing or suction, a flow sensor (not shown) monitors for excessive or unexpected flow of the flushing fluid and issues an alarm or other notification, or takes measures to stop the flow. Excessive flow of the flushing fluid can also be stopped immediately by removing the inner sleeve. Valves, flow limiters, and mechanical or electronic flow and pressure sensors may also be considered.

[0084] In the event of a malfunction or during routine care, the inner cannula 100 can be unhooked, removed, and discarded, then replaced with a new cannula. Conventional catheter-based endovascular suction can be performed regardless of whether the inner cannula 100 is in place. Furthermore, it is noteworthy that this operation can be performed with or without a ventilator / positive pressure source. Moreover, this operation can be used with cuffed or uncuffed catheters or fenestrated or unfenestrated tracheostomy tubes. The actuation device 404 can be controlled by the patient, healthcare provider, or caregiver. In an embodiment, the actuation device 404 can also be driven by an actuation / press mechanism designed to secure and apply buttons 422 and 424 via electronic control. This actuation device can be driven on demand by the patient, healthcare provider, or caregiver, or according to an automatic schedule, or when the electronic monitoring system detects and identifies specific monitoring input conditions. The flushing fluid bottle 416 can be replaced when depleted or according to a set schedule. In addition, any component can be replaced according to a set schedule, or when the patient, medical staff, or caregivers determine that replacement is necessary based on the instructions of the electronic monitoring system or established procedures.

[0085] Various methods can be used to manufacture the flushing-type intraluminal suction inner sleeve system in the embodiments. For example, the inner sleeve 100 or system 200 can be extruded by a die, or a solid plastic roll can be fixed to the sleeve by thermal and / or chemical means to form a raised ridge structure. The holes 125 and grooves 127 on the first conduit 102 can be extruded by a die or formed by heating, drilling, cutting, grinding or other material removal methods. The first conduit 102 can be fused to the rigid plastic second conduit 104 by thermal and / or chemical means. The first conduit 102 and the second conduit 104 can also be manufactured integrally. The flushing fluid line 306 and the suction line 302 can be fixed to corresponding positions on the rigid plastic second conduit 104 by thermal and / or chemical means. Additive manufacturing methods, such as 3D printing, can also be considered.

[0086] Figure 5 This is a flowchart illustrating a method 500 using a flushing-type intraluminal suction cannula system 200. Method 500 includes steps 506 and 508. In an embodiment, method 500 further includes at least one of steps 502 and 504.

[0087] In step 502, the inner cannula 100 is inserted into the outer tracheostomy tube 202 to form a flushing endotracheal suction inner cannula system 200. In one example of step 502, the inner cannula 100 is inserted into an existing outer tracheostomy tube 202 or a dedicated matching tracheostomy tube. The inner cannula 100 is secured to the patient's existing tracheostomy tube 202 or matching tracheostomy tube by a securing clip 106.

[0088] In step 504, the suction line and the flushing fluid line are connected to the inner cannula 100. In one example of step 504, the suction line 302 is connected to the second channel 130 in the second conduit 104. In an embodiment, the flushing fluid line 306 is connected to the first channel 128 in the second conduit 104. In an embodiment, one or both of the suction line 302 and the flushing fluid line 306 may be permanently connected or fused to the second conduit 104.

[0089] In step 506, the suction line and the flushing fluid line are connected to the vacuum source and the flushing fluid source via a drive device. In one example of step 506, the suction line 302 is connected to the vacuum source interface 410 via the drive device 404 and the suction line 406. The flushing fluid line 306 is connected to the flushing fluid bottle 416 via the drive device 404 and the flushing fluid line 414.

[0090] In step 508, the actuation device 404 is used to perform suction alone or in combination with flushing of the internal cannula 100 or system 200. In one example of step 508, button 424 on the actuation device 404 can be pressed to connect suction line 302 to suction line 406 to clear secretions from the lumen space 132 of the patient's tracheostomy tube 202. Additionally, flushing fluid button 422 can be pressed to combine flushing fluid / flushing with suction to flush the lumen space 132 and area 126 of the tracheostomy tube by diluting secretions, allowing for easier suction and clearance within a closed system. The actuation device 404 can be controlled by the patient, hospital staff, or other caregivers. In embodiments, the actuation device 404 can also be integrated into a ventilator (not shown) and programmed to work in conjunction with the operation of the ventilator. Furthermore, the actuation device 404 can be used in conjunction with electronic controls to apply actuation / pressing of actuation buttons (or other methods). Another example is control via eye-tracking devices or neuro-integrated devices, which are used by patients with limited mobility, such as those suffering from neurodegenerative or paralytic diseases (e.g., amyotrophic lateral sclerosis (ALS), trauma, etc.). In any of the above embodiments, the actuator can be driven on demand by the patient, healthcare provider, or caregiver, or on an automated schedule, or when an electronic monitoring system detects and identifies specific monitoring input conditions. In these embodiments, this provides greater flexibility, reduces the burden of care and resource consumption, and minimizes the risk of others being exposed to aerosol particles.

[0091] The accumulation of oral and pharyngeal secretions in the area above the inflatable cuff of the outer tracheostomy tube can lead to the aspiration of small amounts of secretions into the lungs and is associated with the development of ventilator-associated pneumonia (VAP). Therefore, several additional embodiments are considered to integrate separate extraluminal subglottic suction or irrigation combined with suction in this area, while still retaining the intraluminal irrigation and suction functions described herein. These embodiments include, for example… Figures 6A to 6C As shown. Furthermore, the flushing-type intraluminal suction inner cannula system described herein can also be used in conjunction with an outer tracheostomy tube with a window, and additional implementations such as... Figures 6D to 6E As shown.

[0092] Figure 6A It shows Figures 1A to 1D The inner cannula 100 shown can be used in conjunction with an outer tracheostomy tube with a cuff 604, which has an additional suction port 606. In the subglottic region of the cuffed outer tracheostomy tube 602 (i.e., above the cuff 604 of the cuffed outer tracheostomy tube 602 and below the vocal cords, such as...) Figures 7A to 7C(As shown) One or more suction holes 606 are provided. Suction holes 606 can be positioned on the upper surface of the cuffed outer tracheostomy tube 602, covering the corresponding area 126 of the inner cannula 100, thereby extending intraluminal suction into the subglottic space. Additional suction holes 606 (not shown) can also be provided on the opposite side of the cuffed outer tracheostomy tube 602, aligned with the corresponding area 126. However, since the luminal space of the tracheostomy tube used for ventilation communicates with the extraluminal suction channel formed by this design, air leakage may occur in the subglottic space during positive pressure ventilation, leading to patient discomfort or other adverse side effects. Furthermore, this may create a channel for subglottic secretions to enter the intraluminal space, resulting in secretion aspiration into the lower respiratory tract. Due to these drawbacks, two additional embodiments of subglottic suction and subglottic flushing combined with suction are considered, such as... Figure 6B and Figure 6C As shown.

[0093] exist Figure 6B In this embodiment, the inner cannula 608 is an improved version of the inner cannula 100. The following description refers to the accompanying drawings, wherein the same numbers in different drawings represent the same or similar elements unless otherwise stated. An additional channel 610 is provided in the second conduit 104 for connecting a subglottic suction line (not shown). Channel 610 is an example of a second channel 130. Subglottic suction is performed within a region 612 formed by a ridge 614 on the inner cannula. Similar to ridge 112, ridge 614 can form a region or chamber between the inner cannula 608 and the outer tracheostomy tube 616. Ridge 614 begins in the second conduit 104, extends proximally along the length of the inner cannula 608, extends around the circumference of the inner cannula 608 at point 618, then extends distally along the length of the inner cannula 608, ultimately terminating in the second conduit 104. Figure 6B As shown, the ridge 112 is reconfigured so that the inner sleeve 608 can perform the above-mentioned suction or flushing and suction functions inside the lumen.

[0094] It is worth noting that region 612 does not contain holes or slots like region 126, therefore there is no communication between the external space of region 126 or the outer tracheostomy tube 616 and the internal space of the inner tube 608. Instead, slot 620 is located in the outer tracheostomy tube 616, thus covering region 126. This is achieved through a combination... Figure 4 The drive device, either individually or in a similar control manner, allows secretions in the subglottic space outside the lumen to be cleared by suction when suction is applied through channel 610. Figure 6B The embodiment only provides suction to the subglottic space outside the lumen. The first channel 128 in the second catheter 104 can be accessed from... Figures 1A to 1DThe position shown is offset, but it is still connected to region 124 and to the opposite side of the flushing space of the inner sleeve 608 through the through region 622. Therefore, in this design, while retaining the suction and flushing to all the aforementioned holes of the inner sleeve to achieve the flushing function inside the lumen, a new suction path is created, but a small portion of the upper lumen suction area is sacrificed.

[0095] Figure 6C This embodiment integrates flushing and suction functions in the subglottic region outside the lumen, while still enabling intraluminal suction and flushing functions. In this embodiment, the first channel 128 in the second catheter 104 is again offset laterally, but... Figure 6B The same method, through with Figure 6B The ridge 112 shown has the same design, and the first channel 128 is still connected to region 124. Figure 6C In this design, the ridge 614 is replaced by two parallel raised ridges (including an inner ridge 624 and an outer ridge 626). Both the inner and outer ridges 624 originate from the second conduit 104 and terminate thereas, as described above regarding the ridge 614. This forms a region 628 inside the inner ridge 624 and a region 630 between the inner and outer ridges 624 and 626. Similar to regions 124 and 126, regions 628 and 630 form a chamber between the inner cannula 632 and the outer tracheostomy tube 634. Neither region 628 nor 630 contains holes or slots for communication with the luminal space of the inner cannula 632. A channel 638 in the second conduit 104 connects to a suction line (not shown) and communicates with region 628 for providing suction to the subglottic region outside the lumen through an opening 640 on the outer tracheostomy tube 634. The channel 642 in the second conduit 104 connects to the flushing fluid line (not shown) and communicates with region 630, for providing flushing to the subglottic region outside the lumen through openings 644 and 646 on the outer tracheostomy tube 634. (As in combination) Figure 4 The drive device can cause flushing fluid from supply / bottle 416 to flow, be drawn in through channel 642 to mix with secretions in the subglottic space outside the lumen, and then be drawn out through channel 638 to ultimately enter the same or separate suction can or vacuum source interface 410. Other similar modifications and repositioning of the raised ridges and access notches on the inner sleeve 632 and the second conduit 104 for subglottic suction can also be considered. Thus, a new flushing fluid flow path is created while still providing suction and flushing to all the aforementioned orifices of the inner sleeve to achieve the intraluminal flushing function.

[0096] Figure 6DAn embodiment of a flushing endoscopic suction inner cannula 648 for an external tracheostomy tube 650 with a fenestrated opening is shown. In certain clinical situations, an external tracheostomy tube 650 with a fenestrated opening may be necessary to assess a patient's breathing and speaking abilities. The inner cannula 648 can be used with this type of external tracheostomy tube design or a dedicated matching external tracheostomy tube. As shown, the external tracheostomy tube 650 can be cuffed or cuffless. In the region where the fenestration 654 of the external tracheostomy tube 650 is located, a raised, solid block-shaped platform 652 is formed on the inner cannula 648. The platform 652 is sized to abut against the inner surface of the external tracheostomy tube 650. In this way, airflow between the patient's airway and subglottic region is blocked, while flushing and suction can still be provided through the aforementioned ridge 112 and regions 124, 126. This blockage is necessary in certain situations.

[0097] Alternatively, in some cases, it may be necessary to allow air to flow between the patient's airway and subglottic region through a window in the outer tracheostomy tube. To meet this requirement, Figure 6E Another embodiment shown is applicable to an outer tracheostomy tube with a window opening, which allows air to flow through the window opening 654. Figure 6E In the area and shape corresponding to the window 654 on the outer tracheostomy tube 650, the flushing lumen suction inner sleeve 656 includes a generally circular or elliptical raised ridge 658. In this embodiment, an opening is intentionally provided inside the raised ridge 658 leading to the space inside the lumen of the inner sleeve 656.

[0098] Figures 6A to 6E None of the embodiments affect the flushing or suction function of the space within the aforementioned lumen.

[0099] Active use of the system reduces airway aerosol particles because it is a closed system (when used with a ventilator or tracheostomy tube filter) or a near-closed system (when not used with these devices). In either case, it reduces airway aerosols and particles, lowering the risk of infection to others, a risk inherent in standard tracheostomy care.

[0100] In the event of a malfunction or for routine care, the inner cannula 100 can be unhooked, removed, and discarded, and then replaced with a new cannula without replacing the outer tracheostomy tube. Conventional catheter-based endoscopic suction can be performed regardless of whether the inner cannula 100 is in place.

[0101] Figures 1A to 6EAn embodiment of a flushing-type endoluminal suction inner cannula system 200 is shown, wherein the inner cannula 100 integrates a connection to an external device and is connected to the outer cannula or tracheostomy tube 202 using a snap-fit ​​106. In another embodiment, the outer cannula integrates a connection to an external device, as shown in the following figures.

[0102] Figure 8 This is a right front perspective view of a flushing sleeve system 800 with an outer sleeve. Figure 9 yes Figure 8 Right rear perspective view of the casing system. Figure 10 yes Figure 8 The front view of the casing system. Figure 10A yes Figure 10 Side sectional view of the casing system along line 10A-10A. Figure 10B yes Figure 10 A sectional view of the casing system along line 10B-10B. Figure 10C yes Figure 10 A sectional view of the casing system along line 10C-10C. Figures 11 to 12 They are Figure 8 The following description is best viewed from the right and left sides of the casing system. Figures 8 to 12 Let's take a look together.

[0103] For ease of discussion in this article, the figure is labeled 860 ( Figure 10 () refers to the left side of the cannula system 800 when viewed from a non-patient's perspective, and reference numeral 861 refers to the right side of the cannula system 800. For example... Figure 10A As shown, reference numeral 862 refers to the upper side of the casing system 800, and reference numeral 863 refers to the lower side of the casing system 800. The directions are given to clarify the various components and their operation. In the embodiment, any component described as being located on the left and right sides of the casing system 800 may be interchanged. Similarly, any component described as being located on the upper and lower sides of the casing system 800 may be interchanged.

[0104] Figure 8 and Figure 9 A cannula system 800 is shown. The outer cannula includes an outer cannula 802 and a flange 804. The flange 804 may include a hole or interface (not shown) for attaching a strap or other mechanism to secure the flange 804 to the patient's neck. A collar 806 is provided with a suction port 808 and a flushing port 810; the suction port 808 is for connecting to a suction source (e.g., a vacuum source 411). Figure 4 The flushing port 810 is used to connect to a flushing fluid source (e.g., flushing fluid bottle 416). Figure 4 ).

[0105] Connector 812 facilitates the insertion of inner sleeve 814 and can have an adapter size for connection to a standard ventilator circuit. In an embodiment, inner sleeve 814 can be inserted into connector 812 by pressing pins 816 and 818 toward each other during insertion and then releasing them, allowing a tab (not shown) on inner sleeve 814 to engage in opening 820. Opening 820 and corresponding tabs on inner sleeve 814 can be located on opposite sides of connector 812. They can also be located on the circumference of connector 812 at locations other than those shown. In an embodiment, inner sleeve 814 is... Figures 1A to 1E Example of inner sleeve 100.

[0106] The outer sleeve 802 and the inner sleeve 814 are concentric and separated by an annular space. In use, the inner sleeve 814 is inserted into the outer sleeve 802 and extends along the length of the outer sleeve 802 to its proximal end 822. In embodiments, the inner sleeve 814 may be shorter or longer than the outer sleeve 802. As will be described in more detail below, the inner sleeve 814 includes an upper ridge 832, a right ridge 834, a left ridge 836, and a lower ridge 840 located in the annular space between the inner and outer sleeves. These ridges have a height perpendicular to the surface of the inner sleeve 814, the surface of which abuts against the inner lumen 878 of the outer sleeve 802. These ridges form independent regions or chambers in the annular space between the inner sleeve 814 and the outer sleeve 802. In an embodiment, the upper ridge 832 and the right ridge 834 form the upper right chamber 844. The upper ridge 832 and the left ridge 836 form the upper left chamber 846. The lower ridge 840 and the right ridge 834 form the lower right chamber 848. The lower ridge 840 and the left ridge 836 form the lower left chamber 850. The ridges are positioned such that the two upper chambers 844 and 846 are not directly connected to the two lower chambers 848 and 850 except through the lumen of the inner sleeve 814.

[0107] In one embodiment, the inner sleeve 814 may include only two ridges (right ridge 834 and left ridge 836) dividing the annular space into a first (or upper) chamber and a second (or lower) chamber. In other embodiments, the inner sleeve 814 may include only an upper ridge 832 and a lower ridge 840 dividing the annular space into a left chamber and a right chamber. For illustrative purposes, one embodiment is shown, but the principles discussed herein are equally applicable to any case with more than two chambers.

[0108] As described above regarding the inner sleeve 100, the inner sleeve 814 also includes a plurality of grooves 824 and / or holes 825 between the lumen of the inner sleeve 814 and its outer surface. The grooves 824 and holes 825 allow flushing fluid and secretions to move between the lumen of the inner sleeve 814 and the annular space between the inner sleeve 814 and the outer sleeve 802.

[0109] When the inner sleeve 814 is inserted into the outer sleeve 802, the prongs 816 and 818 are pressed against each other until the ring 830 abuts against the distal end 842 inside the outer sleeve 802, forming an annular seal. When fully inserted, the tabs 838 on the inner sleeve 814 are engaged in the openings 820 on both sides of the connector 812 to secure the inner sleeve 814 in place.

[0110] The flushing port 810 has a channel 826 located between the flushing fluid source and the upper left chamber 846 and the upper right chamber 844. The suction port 808 has a channel 828 located between the suction source and the lower right chamber 848 and the lower left chamber 850. The communication between the upper chambers and between the lower chambers will be described in more detail below. Tubing (not shown) for providing flushing fluid or suction will be inserted into or fused into the flushing port 810 and the suction port 808, respectively. In embodiments, the tubing inserted into the ports may have a beveled design to align with the ends of channels 826 or 828, allowing fluid to flow smoothly back and forth between the chambers between the inner sleeve 814 and the outer sleeve 802. The flushing port 810 and the suction port 808 may have a keyed design to match the keys on the tubing to ensure proper connection. For example, the flushing port 810 and the suction port 808 may be generally circular with flat edges that match the flat edges on the tubing. Other keying structures, such as tabs and slots, can also be used.

[0111] Figure 13 This is used in the embodiments Figure 8 A perspective view of the flushing inner casing of the casing system. Figure 14 yes Figure 13 Side view of the inner sleeve. Figures 14A to 14C yes Figure 14 A sectional view. Figure 15 yes Figure 13 The front view of the inner sleeve. The following description is best viewed in conjunction with... Figures 13 to 15 Let's take a look together.

[0112] The inner sleeve 814 includes multiple longitudinal ridges on its surface. These ridges are sized to abut against the inner lumen 878 of the outer sleeve 802 and divide the annular space between the sleeves into independent and distinct chambers within the annular space. The upper ridge 832 divides half of the annular space into the upper right chamber 844 and the upper left chamber 846 (in... Figures 13 to 15 (Not visible in the middle).

[0113] The upper ridge 832 extends along most of the length of the inner sleeve 814, terminating a short distance near the proximal end of the inner sleeve 814 at a proximal end 854. At the distal end of the upper ridge 832, the upper gap 852 provides an opening between the upper right chamber 844 and the upper left chamber 846. Because the flushing port 810 is positioned near the upper left chamber 846, the upper gap 852 allows flushing fluid to flow between the two upper chambers. The upper right chamber 844 and the upper left chamber 846 terminate at the proximal end 854 of the upper ridge. Figure 14C As shown, the inner sheath 814 has a thickness at its proximal end equal to the height of the ridge and abuts against the lumen 878 of the outer sheath 802. A right upper flange 856 is formed at the proximal end of the right upper chamber 844. A similar left upper flange (not shown) is formed at the proximal end of the left upper chamber. When the inner sheath 814 is removed, the right upper flange 856 and the left upper ridge scrape against the lumen 878 of the outer sheath 802, thereby providing an additional mechanism for clearing secretions and build-up from the inner surface of the outer sheath 802.

[0114] The lower ridge 840 extends along most of the length of the inner cannula 814, terminating a short distance proximal to the inner cannula 814 at the proximal end 858. The lower gap 866 has an opening between the right lower chamber 848 and the left lower chamber 850. Because the suction port 808 is positioned near the right lower chamber 848, the lower gap 866 allows secretions to flow between the two lower chambers for removal by suction. The right lower chamber 848 and the left lower chamber 850 terminate at the proximal end 858 of the lower ridge. Figure 14C As shown, the inner sheath 814 has a thickness at its proximal end equal to the height of the ridge and abuts against the lumen 878 of the outer sheath 802. A lower flange 864 is formed at the proximal end of the right lower chamber 848, and a lower flange 865 is formed at the proximal end of the left lower chamber 850. When the inner sheath 814 is removed, these lower flanges scrape against the lumen 878 of the outer sheath 802, thereby providing an additional mechanism for clearing secretions and build-up from the inner surface of the outer sheath 802.

[0115] Figure 14A This is a cross-sectional view of the inner sleeve 814 in the region of the upper gap 852 and the lower gap 866. Reference numerals 860, 861, 862, and 863 refer to the left, right, upper, and lower sides of the sleeve system 800, respectively. For reference, the inner lumen 878 of the outer sleeve 802 is shown in dashed lines. The right ridge 834 and the left ridge 836 abut against the inner lumen 878, thereby creating an air space between the inner sleeve 814 and the outer sleeve 802 near the upper gap 852 and the lower gap 866.

[0116] Figure 14BThis is a cross-sectional view of the inner sleeve 814 at its midpoint along its length. The upper ridge 832 and the right ridge 834 form the upper right chamber 844, while the upper ridge 832 and the left ridge 836 form the upper left chamber 846. Similarly, the lower ridge 840 and the right ridge 834 form the lower right chamber 848, while the lower ridge 840 and the left ridge 836 form the lower left chamber 850. For reference, the inner lumen 878 of the outer sleeve 802 is shown in dashed lines.

[0117] Figure 14C This is a cross-sectional view of the inner sleeve 814 at its proximal end. Surface 880 is the outer surface of the inner sleeve 814. Except for the area of ​​the suction groove 868, which will be described in more detail below, the entire surface 880 abuts against the inner lumen 878 of the outer sleeve 802.

[0118] The 800 bushing system can be used with Figure 4 The flushing and suction device shown is used in conjunction with the cannula system 200 and functions similarly to it. A suction source is connected to a suction port 808. Secretions within the lumen of the inner cannula 814 are suctioned out through slots 824 in the right lower chamber 848 and left lower chamber 850. Secretions within the trachea proximal to the cannula system 800 can also be suctioned through suction slots 868 located on either side of the lower chambers 848 and 850. Figure 14 The grooves can be drawn out. These grooves may have different sizes, shapes or positions, but in this embodiment, they are offset at an angle to the lower chambers 848 and 850, such that when the inner sleeve 814 is removed, the inner sleeve 814 scrapes the entire circumference of the inner surface of the outer sleeve 802, thereby physically removing secretions and deposits from the inner surface of the outer sleeve 802.

[0119] The cannula system 800 can be used alone with suction to remove secretions. Alternatively, a flushing fluid source can be connected to the flushing port 810. When secretions are removed through the suction port 808, flushing fluid is drawn into the upper left chamber 846 and upper right chamber 844, and enters the lumen of the inner cannula 814 through the orifice 825. Subsequently, the flushing fluid, along with any secretions within the lumen, is aspirated through the groove 824, enters chambers 848 and 850, and flows towards the suction port 808. The flushing fluid flowing through the various areas of the cannula system 800 helps dilute secretions and flush them away from the cannula surface, resulting in more successful and thorough removal of secretions.

[0120] Figure 16 This is a right front perspective view of the outer sleeve 870 with cleaning features in the embodiment. Figure 17 yes Figure 16 Side view of the outer tube. Figure 18 yes Figure 16 The front view of the outer tube. Figure 19 yes Figure 18 A sectional view of the outer tube along line 19-19. Figure 19A yes Figure 19 The exploded diagram. The following description is best viewed in conjunction with... Figures 16 to 19A Let's take a look together.

[0121] The outer tube 870 is an example of the outer tube 802. The suction port 808 and channel 828 are modified from a straight shape to a Y-shaped configuration to accommodate the plunger 876. The plunger 876 is used to manually clear the channel 874 by withdrawing the plunger from the cylinder. Figure 19A The secretions within the channel 874 will be understood by those skilled in the art. In an embodiment, when the plunger 876 is not in use, it can be removed and replaced with a cap or stopper. A spare suction position 872 can be provided for connecting the tubing to a suction source. The plunger 876 can be used periodically as needed to clear secretions or accumulated crusts within the channel 874.

[0122] Figures 6A to 6E Any of the embodiments shown can also be used in conjunction with the sleeve system 800 or the outer sleeve 870.

[0123] Various modifications can be made to the inner cannula 100 or the system 200. For example, additional ridges can be used for the first catheter 102 to create more areas or chambers / channels for monitoring devices and / or drug delivery. The ridges 112 on the first catheter 102 can be reconfigured to different patterns, thereby forming flushing chambers and vacuum chambers of different shapes, which may change their function. Similarly, the channels in the second catheter 104 can be reconfigured to different patterns or shapes to enable flushing in the suction chamber. The ridges 112 can allow communication between the patient's airway and the external environment for airway monitoring devices and / or measurement purposes, or for drug (droplet, aerosol, etc.) delivery.

[0124] The inner sleeve 814 may not have upper, lower, left, and right ridges, but only a right and left ridge, or an upper and lower ridge. In other words, the annular space between the inner sleeve 814 and the outer sleeve 802 can be divided into two chambers, one connected to the flushing port and the other connected to the suction port.

[0125] The outer tracheostomy tube 202 may be configured with grooves or recessed structures to facilitate insertion, achieve different or better functions, or facilitate cleaning. The position, size, pattern, and shape of the holes and / or grooves on the first conduit 102 can be reconfigured to alter fluid flow and suction properties. In embodiments, the inner sleeve 100 may be lengthened (exceeding the tip of the outer tracheostomy tube 202) or shortened (within the lumen of the outer tracheostomy tube 202) to further enhance operability.

[0126] The flushing and suction lines can be adjusted by changing their positions, diameters, lengths, and connections on the rigid plastic lumen of the invention to achieve the same suction effect. The shape and configuration, length, and existing window shape and configuration of the retaining clips, lumen, and ridges can be adjusted to be used with different existing tracheostomy tubes currently on the market, which differ in some or all of these aspects.

[0127] Flushing-type endoluminal aspiration cannula systems can be used in: other applications or technical fields where frequent catheter replacements are required due to the accumulation of debris, secretions, or other substances in the inner lumen; or, similar systems where a replaceable inner lumen / cannula is unavailable but which can benefit from this design to prevent clogging (which would cause damage or failure to the system and is currently typically addressed by endoluminal catheter aspiration). This can be applied in both medical and non-medical settings.

[0128] In medical settings, the flushing-type endoluminal aspiration cannula system can be applied to other medical devices / implanted tubes that communicate with the external environment, such as endotracheal tubes, nasotracheal tubes, gastrostomy tubes, colostomy tubes, nephrostomy tubes, intraperitoneal tubes, surgical drainage tubes, or other similar applications in the medical field. This flushing-type endoluminal aspiration cannula system can be used in a variety of scenarios, including inpatient and outpatient / portable settings.

[0129] The aforementioned functions of the flushing lumen suction inner cannula system can be guided or executed by a computer, machine, or other electronic device used to monitor and / or drive the aforementioned functions.

[0130] Flushing-type endoluminal suction cannula systems and their described, implied, or derived uses can produce substances of use or value. Monitoring the secretions generated during their use may have diagnostic uses for healthcare providers. The system can also detect the presence of specific pathogens in secretions that can be detected or cultured without introducing additional instruments into the patient's airway, thereby reducing the risks associated with additional procedures.

[0131] Regardless of whether mechanical or electronic control is used, health outcome data obtained through the regular or automated use of flushing endovascular suction cannula systems can be valuable in developing patient care protocols, reducing morbidity and / or mortality, and developing patient care algorithms. Improved airway hygiene (a recognized standard of care for tracheostomized patients) can lead to improved patient health outcomes.

[0132] The flushing-type intraluminal suction cannula system functions simply by being properly secured and connected to a flushing fluid source or other flushing liquid and a negative pressure source (vacuum). By controlling the flushing fluid and suction, the safety and comfort of the system can be improved.

[0133] Modifications to the methods and systems described herein may be made without departing from the scope of this document. Therefore, it should be noted that the content contained in the above description or shown in the accompanying drawings should be understood as illustrative, not restrictive. In this document, unless otherwise stated: (a) the adjective “exemplary” is meant as an example, instance, or illustration; (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 expressions relating to the scope of the methods and systems, which, linguistically, should be considered to fall within the foregoing scope.

[0134] Those skilled in the art can rearrange the position or size, configuration, ridge, volume, and shape of the windows in the flushing chamber and the suction chamber, as alternative configurations for various intended functions remain within the scope of the principles discussed herein.

Claims

1. An irrigation cannula system for tracheotomy, comprising: The outer tube includes an attraction interface for connecting to an attraction source; as well as Inner sleeve, sized to be inserted into the outer sleeve, the inner sleeve comprising: Outer surface; Multiple longitudinal ridges are located on the outer surface, abutting against the lumen of the outer sleeve, and dividing the annular space between the inner sleeve and the outer sleeve into at least a first chamber and a second chamber; A flange formed at the proximal ends of at least the first chamber and the second chamber, the flange abutting against the lumen of the outer sleeve; and Multiple holes are located in the outer surface between the annular space and the lumen of the inner sleeve; The second chamber is coupled to the suction port to draw secretions from the first chamber, through the lumen of the inner cannula into the second chamber, and out of the suction port.

2. The flushing sleeve system as described in claim 1, wherein, The outer sleeve also includes a flushing interface for connecting to a flushing fluid source.

3. A flushing sleeve system, comprising: The outer tube includes: a suction port for connecting to a suction source and a flushing port for connecting to a flushing fluid source; Inner sleeve, sized to be inserted into the outer sleeve, the inner sleeve comprising: Outer surface; Multiple longitudinal ridges are located on the outer surface, abutting against the lumen of the outer sleeve, and dividing the annular space between the inner sleeve and the outer sleeve into at least a first chamber and a second chamber; A flange located proximal to the end of each of the plurality of chambers, the flange abutting against the lumen of the outer sleeve; and Multiple holes are located in the outer surface between the annular space and the lumen of the inner sleeve; The first chamber of the plurality of chambers is coupled to the flushing port to receive flushing fluid from the flushing fluid source, while the second chamber is coupled to the suction port to draw out secretions and flushing fluid from the first chamber, pass through the lumen of the inner sleeve into the second chamber, and discharge from the suction port. A flushing fluid line, which is connected to the flushing port; A suction conduit, which is connected to the suction port; and A drive device is coupled between the flushing fluid line and the flushing fluid source, and coupled between the suction line and the vacuum source, the drive device controllingly connecting the flushing fluid line to the flushing fluid source and the suction line to the vacuum source.

4. The casing system as described in claim 3, wherein, The outer sleeve further includes a groove on its inner surface, corresponding to the plurality of longitudinal ridges, such that when the inner sleeve is inserted into the outer sleeve, the plurality of longitudinal ridges engage with the groove.

5. The casing system as described in claim 3, wherein, The drive device can be coupled only between the suction line and the inner sleeve.

6. The casing system as claimed in claim 3, wherein, The drive unit can be integrated into a ventilator.

7. The casing system as claimed in claim 3, wherein, The flushing fluid source is positioned at a certain distance below the vertical height of the inner sleeve to prevent spontaneous flow.

8. The casing system of claim 7, further comprising: Flow sensors used to monitor the flow of flushing fluid or suction fluid.

9. The casing system of claim 8, further comprising: Valves, flow limiters, mechanical flow and pressure sensors, or electronic flow and pressure sensors.

10. The casing system of claim 9, further comprising: An alarm or notification will be issued if excessive or unexpected flow of flushing fluid or suction is detected.

11. The casing system of claim 6, wherein, The inner sleeve also includes a tab for fixing the inner sleeve inside the outer sleeve.

12. The casing system of claim 3, wherein, The tracheostomy system is a cuffed tracheostomy tube or a cuffless tracheostomy tube.

13. The casing system of claim 3, wherein, The cannula system is a tracheostomy tube with or without a window.

14. A method for cleaning a tracheostomy tube, the tracheostomy tube comprising an outer sheath and an inner sheath, the inner sheath comprising a plurality of holes and one or more ridges, wherein when the inner sheath is inserted into the outer sheath, the one or more ridges divide the air space between the outer tracheostomy tube and the inner sheath into a plurality of regions, the method comprising: Connect the suction line to the inner sleeve so that the suction line is in communication with the first region of the plurality of regions; A drive device is connected between the suction line and the vacuum source, and the drive device is connected to the suction line and the vacuum source in a controllable manner; as well as The drive device is controlled to draw suction from the lumen of the inner sleeve through the first portion of the plurality of holes, the first region, and the suction conduit.

15. The method of claim 14, further comprising: Connect the flushing fluid line to the inner sleeve so that the flushing fluid line is in communication with the second area of ​​the plurality of areas; The drive device is connected between the flushing fluid pipeline and the flushing fluid source, and the drive device is connected to the flushing fluid pipeline and the flushing fluid source in a controllable manner; as well as The drive device is controlled to supply flushing fluid to the lumen of the inner sleeve through the second portion of the plurality of holes, the second region, and the flushing fluid conduit.

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