System and Method of a Tracheostomy Tube Having a Secondary Vent Opening and a Double Cuff Assembly

Abstract

The cuff assembly for a tracheostomy tube comprises an outer bladder and an inner cuff. The inner cuff is disposed adjacent to the tracheostomy tube, and the outer bladder is disposed adjacent to the inner cuff. The outer bladder is made of a material with low elasticity and operates at a higher relative pressure. The inner cuff is made of a material with higher elasticity or superelasticity and operates at a lower relative pressure. A secondary ventilation opening is formed in the side wall of the tracheostomy tube between the cuff assembly and the main distal opening of the tracheostomy tube.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application No. 17 / 902,691, filed on September 2, 2022, entitled "System and Method for a Tracheostomy Tube with a Secondary Airflow Opening and a Dual Cuff Assembly", which claims priority under 35 U.S.C. § 120 as a continuation - in - part of U.S. Patent Application No. 17 / 848,273, filed on June 23, 2022, entitled "System and Method for an Endotracheal Tube Cuff Assembly".

[0002] This application relates to systems and methods for a cuff assembly implemented in a medical device, and more particularly, to a tracheostomy tube having a secondary airflow opening, a cuff assembly, and a secretion collection and removal system.

Background Art

[0003] A tracheostomy tube is a generally L-shaped tube that includes a flange, an outer cannula, an inner cannula, and a cuff. The outer cannula is divided into a proximal segment, a curved segment, and a distal segment. The proximal and distal segments of the tracheostomy tube are relatively straight and are connected via an intermediate curved segment. The distal segment and the curved segment are surgically inserted into the patient through a tracheostomy stoma (a hole opened in the neck and trachea), and the distal segment is arranged along the longitudinal axis of the trachea. The proximal segment is oriented approximately 90 degrees from the distal segment and protrudes from the tracheostomy stoma. The flange extends from the side of the proximal segment to stabilize the tracheostomy tube outside the tracheostomy stoma. There are slits or holes at the opposite end of the flange for attaching cloth strings or straps that wrap around the neck. The inner cannula is nested inside the outer cannula and can be removed or replaced to keep the tracheostomy tube clean.

[0004] An inflatable cuff is disposed on the distal segment of the tracheostomy tube and is placed inside the trachea. An inflation tube is connected to a pilot balloon and a one-way inflation valve to inflate the cuff. In known tracheostomy tubes, the inflatable cuff occupies almost the entire length of the distal segment and aids in preventing fluid leakage into the patient's lungs.

[0005] The tracheostomy tube is connected to a ventilator and serves as a conduit for the patient to breathe when the patient has airway stenosis or obstruction proximal to the trachea (upper airway). Such upper airway obstructions can occur due to infectious diseases, tumors, trauma, bleeding, etc. For patients with acute airway obstruction, the tracheostomy tube can be life-saving. However, if the tracheostomy tube becomes blocked, the patient has no alternative breathing means, so the blockage can be fatal. Unfortunately, blockage of the tracheostomy tube opening is not uncommon. The most common causes of blockage are thick secretions, mucus plugs, blood clots, foreign bodies, kinking or dislodging of the tube, etc.

[0006] There are currently systems for removing such secretions in tracheotomy tubes, but these systems are not ideal and often cannot prevent blockages.

[0007] Furthermore, the main goal of an inflatable cuff is to maximize the seal of the airway and minimize damage to the airway. Although this goal seems straightforward, its achievement is not easy. Despite various improvements and advancements regarding materials, shape, and volume structure, this failure continues.

[0008] Considering the above-mentioned drawbacks described herein, there is a need for an improved tracheotomy tube that provides a means for a patient to breathe when the opening of the main tracheotomy tube is blocked. Furthermore, there is a need for improved systems and methods for collecting and removing secretions to prevent blockage of the tracheotomy tube. Additionally, there is a need for an improved cuff system that helps reduce microaspiration and infection in the lungs by maintaining a good seal with the tracheal wall without overly damaging the tracheal wall.

Summary of the Invention

[0009] In one aspect, a tracheotomy tube includes an outer cannula having a distal segment, the distal segment including a main distal opening. The tracheotomy tube also includes a cuff assembly in the distal segment of the tracheotomy tube. The cuff assembly includes an inflatable inner cuff having an inner surface and an outer surface, the inner surface being an inner cuff disposed adjacent to the outer cannula, and an inflatable outer bladder disposed adjacent to the outer surface of the inner cuff. The inner cuff has a first elasticity, and the outer bladder has a second elasticity smaller than the first elasticity of the inner cuff. The distal segment further forms a secondary ventilation opening between the cuff assembly and the main distal opening.

[0010] In another aspect, the tracheostomy tube comprises a cuff assembly having an inflatable inner cuff with an inner surface and an outer surface, the inner cuff being configured for a first pressure range, and an inflatable outer bladder adjacent to the outer surface of the inner cuff, the outer bladder being configured for a second pressure range, wherein the first pressure range of the inner cuff is less than the second pressure range of the outer bladder. The tracheostomy tube includes an outer cannula having a main distal opening, the inner surface of the cuff assembly being disposed adjacent to the outer cannula, and the outer cannula forms a secondary ventilation opening between the cuff assembly and the main distal opening.

[0011] In one or more of the above aspects, the secondary ventilation opening includes a plurality of openings formed in a side wall of a distal segment between the cuff assembly and the main distal opening.

[0012] In one or more of the above aspects, each of the plurality of openings has an inclined wall, and an inner opening of each of the plurality of openings is distal to an outer opening of each of the plurality of openings.

[0013] In one or more of the above aspects, the inner cannula is disposed inside the outer cannula, and the secondary ventilation opening formed in the outer cannula includes at least one opening that substantially exposes a plurality of openings formed in the inner cannula.

[0014] In one or more of the above aspects, the secondary ventilation opening formed in the outer cannula includes a first plurality of openings formed in the outer cannula that are substantially aligned with a second plurality of openings formed in the inner cannula.

Brief Description of the Drawings

[0015]

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Best Mode for Carrying Out the Invention

[0016] As used herein, the terms "exemplary" or "embodiment" mean "an example, a practical example, serving as an explanation." Embodiments or aspects described herein as "exemplary" or "embodiments" should not necessarily be construed as being more preferable or advantageous than other aspects of the present disclosure. Similarly, the term "aspects" does not require that all aspects of the present disclosure include the features, advantages, or modes of operation discussed.

[0017] Embodiments will be described in detail below with reference to the drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the aspects described herein. However, it will be apparent to those skilled in the art that some or all of these specific details may not be required to practice these and other aspects. Further, well-known steps in a process method may be omitted from the flow diagrams presented herein to avoid obscuring the aspects of the present disclosure. Similarly, well-known components within an apparatus may be omitted from the figures and their description presented herein to avoid obscuring the aspects of the present disclosure.

[0018] Example of a secondary ventilation opening FIG. 1 is an elevational view of an exemplary embodiment of a tracheostomy tube 100 having a secondary ventilation opening 128. The tracheostomy tube 100 includes an outer cannula 102 and an inner cannula 150, and the inner cannula is disposed inside the outer cannula. The outer cannula 102 and the inner cannula 150 may be made of a flexible polyvinyl chloride (PVC) material.

[0019] The outer cannula 102 includes a proximal segment 112, a curved intermediate segment 114, and a distal segment 116. The proximal segment 112 of the outer cannula 102 includes a flange 108 or plate that extends circumferentially outward from the outer cannula. The flange 108 has two slits 118a, 118b on opposite sides. A cotton bandage or strap is fixed to the slits 118a, 118b of the flange to hold the tracheostomy tube 100 around the patient's neck. The proximal segment 112 further includes a hub 110 that extends outward from the flange 108. The inner cannula 150 is inserted through the proximal opening of the hub 110. Thereafter, the proximal end of the inner cannula 150 is connected to a ventilator.

[0020] The outer cannula 102 of the tracheostomy tube 100 includes a curved intermediate segment 114 and a distal segment 116 configured to fit within the patient's trachea. The intermediate segment 114 is curved such that the proximal segment 112 is at an angle of about 80 degrees to about 90 degrees with respect to the distal segment 116. The distal segment 116 includes a cuff assembly 120, a distal end 126, and a main distal opening 138. The main distal opening 138 is the opening at the distal end of the tracheostomy tube 100 and is formed, for example, by the end of the tracheostomy tube 100. For example, the main distal opening 138 is formed between the distal bottom surface 140 of the wall 132 of the outer cannula 102 and the distal bottom surface 142 of the wall of the inner cannula 150 (if present).

[0021] The cuff assembly 120 includes an inner cuff 124 and an outer bladder 122, as will be described in detail below.

[0022] In currently known tracheostomy tubes, due to structural constraints, a secondary ventilation opening cannot be provided. The main limitation is the lack of space required at the distal end 126 between the inflatable cuff and the main distal opening 138. The secondary ventilation opening must have a total area sufficient to maintain an air flow for the patient's respiration when the main distal opening 138 is blocked. As described above, in currently known tracheostomy tubes, the inflatable cuff occupies almost the entire length of the distal segment 116. Therefore, the length of the distal end 126 from the inflatable cuff to the main distal opening 138 is insufficient for the secondary ventilation opening.

[0023] In this specification, a novel cuff assembly 120 that is shorter in length than a general inflatable cuff will be described. For example, the length of the cuff assembly L CA is from about 10 millimeters (mm) to about 20 mm, in contrast to about 30 mm of current tracheostomy tubes. Since the length of this novel cuff assembly 120 is shortened, the length of the distal end 126 exposed between the cuff assembly 120 and the main distal opening 138 becomes longer. By thus lengthening the exposed length of the distal end 126, a secondary ventilation opening 128 can be provided. The secondary ventilation opening 128 is formed in the transverse wall (side wall) 132 of the distal segment 116 between the cuff assembly 120 and the main distal opening 138. The secondary ventilation opening 128 functions as an alternative conduit for the patient to breathe when the main opening 138 of the tracheostomy tube is blocked.

[0024] In this embodiment, the secondary ventilation opening 128 includes a plurality of fenestrations 130 formed in the wall 132 of the outer cannula 102 and the wall of the inner cannula 150. The fenestrations 130 of the outer cannula 102 need to be substantially aligned with the fenestrations of the inner cannula 150. For example, for substantial alignment, it is necessary that the fenestrations 130 of the outer cannula 102 are aligned with at least about 80 percent of the corresponding fenestrations of the inner cannula 150. The alignment of the outer cannula 102 and the inner cannula 150 is guided by the suction channel 136 and the suction catheter 134, as will be described in detail below.

[0025] In one example, the respective diameters of the fenestrations 130 are from 1 mm to 3 mm, and the total area of the plurality of fenestrations is from about 20 square mm to about 80 square mm (corresponding to the length L of the distal end DE ). This provides sufficient air flow. Other sized openings or total areas of the fenestrations 130 may be implemented. The fenestrations 130 are spaced apart by an amount of material sufficient to maintain the structural integrity of the outer cannula 102. Thus, the plurality of fenestrations 130 provide a secondary ventilation opening 128 for sufficient ventilation when the main distal opening 138 is blocked.

[0026] In one embodiment, each of the fenestrations 130 has an angled or tilted wall, for example, the wall is angled with respect to the centerline of the distal end 126. For example, the inner opening of the fenestration 130 is distal to the outer opening. The angle of the fenestration wall can be between 10 degrees and 45 degrees with respect to the centerline of the distal end 126. This configuration of the fenestration 130 helps prevent the tip of the suction catheter from catching on the inner opening of the fenestration 130.

[0027] Example of a dual cuff assembly The tracheotomy tube 100 includes a novel cuff assembly 120 disposed in the distal segment 116. Currently, there are mainly two types of cuffs: low volume - high pressure (LVHP) cuffs and high volume - low pressure (HVLP) cuffs. The former type, LVHP cuffs, are harder and made of a relatively non - elastic material. Since LVHP cuffs are inherently hard, a higher pressure (50 cmH2O to 100 cmH2O) is required to inflate the LVHP cuff. As a result, even when the LVHP cuff is inflated to the minimum pressure to create a seal with the tracheal wall, it will apply an excessive high pressure to the tracheal mucosa. This high pressure causes an unacceptably high incidence of tracheal ischemia and necrosis, with the incidence rate ranging from 5% to 20%. Nevertheless, when the LVHP cuff is inflated, there is an important advantage that there are relatively few wrinkles and folds, so the tracheal sealing performance is excellent. LVHP cuffs were first adopted in the 1960s, but today they have been widely replaced by HVLP cuffs.

[0028] The HVLP cuff is composed of a more stretchable and flexible material that expands at low pressure. To compensate for its low pressure characteristics and create a seal against the tracheal wall, the diameter of the HVLP cuff is usually 1.5 to 2 times the diameter of the trachea when fully inflated. However, when the volume of the HVLP cuff increases, a large amount of cuff material is required, and the HVLP cuff bulges, making intubation difficult. Furthermore, the extra material tends to form wrinkles and folds due to "incomplete inflation". These wrinkles and folds create a pathway for gastric secretions to pass over the HVLP cuff, ultimately leading to microaspiration and lung infections.

[0029] When examining the effect of cuff pressure on the trachea, it is important to note that the human tracheal wall mucosal capillary perfusion pressure is 22 - 32 mmHg, and when a pressure of 30 cmH2O (22 mmHg) or more is applied, tracheal mucosal blood flow is impaired, and at 50 cmH2O (37 mmHg), blood flow to certain parts may be completely blocked. That is, it is clear that there is only a small overlap between the safe pressure range and the complication range. The frame of effectiveness and safety is very narrow, if not non - existent.

[0030] For a general HVLP cuff, the pressure required to achieve proper inflation with wrinkles and folds within an acceptable range is approximately 32 cmH2O. In the guidelines set by various medical associations and groups, to avoid occlusion of tracheal mucosal blood flow, it is recommended to maintain the HVLP cuff pressure at 20 cmH2O - 30 cmH2O. However, even when adhering strictly to the recommendations, many patients are still in a dangerous situation. In fact, according to a certain study, approximately 10% of patients using ventilators develop ventilator - associated pneumonia (VAP), and the mortality rate due to VAP is estimated to be 13%. Furthermore, VAP patients have a longer hospital stay and higher medical costs than patients with similar illnesses without VAP. Considering that approximately 750,000 patients in the United States require mechanical ventilation annually, the human and financial damage caused by VAP is enormous.

[0031] Unfortunately, studies have shown that even at a pressure of up to 60 cmH2O, microaspiration occurs with HVLP cuffs, and it has been suggested that even at high pressures, wrinkles remain in the cuffs and there is a possibility of secretions passing through. Although HVLP cuffs appear to be superior because they can be sealed at lower pressure levels and avoid tracheal wall necrosis, they are still hardly ideal.

[0032] Returning to FIG. 1, the cuff assembly 120 will be described in more detail. Unlike conventional cuffs, the cuff system 120 includes at least two individually controlled inflation bladders. The cuff assembly 120 includes a first inner cuff 124 disposed adjacent to the outer cannula 102 and configured to expand radially outward from the tracheotomy tube 100. A second, toroidal outer bladder 122 is disposed adjacent to the inner cuff 124, and at least a portion of the inner cuff 124 is disposed between the outer bladder 122 and the tracheotomy tube 100. The outer bladder 122 is configured to expand radially outward from the inner cuff 124 such that the outer surface of the outer bladder 122 contacts the tracheal wall.

[0033] The inner cuff 124 and the outer bladder 122 can be cylindrical or toroidal. For example, as seen in FIG. 1, the outer bladder 122 is a toroidal ring with a circular cross-section when inflated. The inner cuff 124 is cylindrical with an arched outer surface that forms a ring around the tracheotomy tube 100. In this example, the length of the inner cuff is 10 mm to 20 mm, and the length of the outer cuff is 5 mm to 9 mm. The outer bladder 122 is adhered to the inner cuff 124 and is not fixed to the cannula 102 outside the tracheotomy tube 100. The inner cuff 124 is attached to the outer cannula 102 by an adhesive and / or a band.

[0034] The inner cuff 124 and the outer bladder 124 have separate inflation means. For example, a first inflation tube 106a is disposed within a first channel of the outer cannula 102 and has a distal end coupled to the inner cuff 124. The proximal end of the first inflation tube 106a extends from the hub 110 and is connected to a pilot balloon and a unidirectional inflation valve for inflating the inner cuff 124. Another second inflation tube 106b is disposed within a second channel of the outer cannula 102 and has a distal end coupled to the outer bladder 122. The proximal end of the second inflation tube 106b extends from the hub 110 and is connected to a pilot balloon and a unidirectional inflation valve for inflating the outer bladder 122.

[0035] By separate inflation tubes 106a-b, the outer bladder 122 and the inner cuff 124 can be inflated at different pressures and maintain those pressures. In one embodiment, the inner cuff 124 is a low-pressure inflatable cuff and is configured to function within a low-pressure range of 10 cmH2O to 20 cmH2O. In contrast, the outer inflation bladder 122 is configured to inflate up to a high-pressure range of 50 cmH2O to 150 cmH2O. Thus, the inner cuff 124 operates at a pressure range lower than that of the outer bladder 122.

[0036] Furthermore, the inner cuff 124 is made of a relatively elastic material, while the outer bladder 122 is made of a relatively non-elastic material. For example, the material of the outer bladder 122 is less elastic than the material of the inner cuff 124. For example, the relatively elastic material of the inner cuff 124 may include one or more of rubber, silicone, latex, polyvinyl chloride (PVC), neoprene, polyisoprene, or polyurethane (PU). The relatively non-elastic material of the outer bladder 122 may include one or more of polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0037] During use, for example, when inserted into the trachea and pressurized to an inflated state, the first inner cuff 124 operates as an HVLP cuff, and the second outer bladder 122 operates as an LVHP cuff. The more flexible inner cuff 124 can mitigate the pressure (the "intratracheal pressure") applied to the tracheal wall by the more pressurized outer bladder 122. In other words, the lower-pressure and elastic inner cuff 124 is configured to absorb the excessive pressure that might be exerted on the tracheal wall by the outer bladder 122. For example, since the inner cuff 124 is more flexible and elastic, the cuff assembly 120 applies a lower total pressure / force to the tracheal wall, for example, a pressure lower than the outer bladder pressure. The force of the inner cuff 124 acts radially on the outer bladder 122, and ultimately the force applied to the trachea is represented as the intratracheal pressure. That is, the radial force generated by the inner cuff 124 and acting on the outer bladder 122 becomes the intratracheal pressure. For example, when the outer bladder pressure is greater than the inner cuff pressure and the outer bladder expands and its outer surface contacts the trachea, the pressure between the cuffs becomes the same as the intratracheal pressure.

[0038] Furthermore, since it operates at high pressure, the inflated outer bladder 122 has fewer wrinkles or folds, for example, than an LVHP cuff, and forms a relatively smooth surface. The reduction in wrinkles reduces the risk of leakage and forms a more uniform tracheal seal.

[0039] In this way, the cuff assembly 120 reduces tracheal complications by utilizing an innovative system for titrating the intratracheal pressure. By incorporating the characteristics of HVLP and LVHP cuffs into one system, the cuff system 120 utilizes the advantages seen in both types of cuffs, namely excellent tracheal sealing and higher safety for the trachea. The cuff system 120 is characterized by excellent sealing performance against the tracheal wall and little damage to the trachea. Therefore, the cuff assembly 120 helps protect the lungs from contamination by gastric contents and blood without overly damaging the tracheal wall.

[0040] In one embodiment, the tracheostomy tube 100 also includes a secretion removal system implemented to remove secretions, aspirates or other fluids that may accumulate around the proximal side of the cuff assembly 120. A suction channel 136 is formed in the rear of the outer cannula 102 and extends from the hub 110 to a point just proximal to the inner cuff 122, where it forms an opening. In one example, the inner cannula 150 has a cylindrical L-shape with a rear outer wall indentation configured to form an upper portion of the suction channel 136, as shown and described in more detail with respect to FIG. 5A. The outer cannula 102 has a cylindrical L-shape with a rear inner wall indentation configured to form a lower portion of the suction channel 136.

[0041] As shown in more detail with respect to Figures 3 and 4, an opening is formed in the outer wall of the cannula 102 that fluidly connects the suction channel 136 to the trachea. This opening is preferably located on the rear side of the outer cannula 102 proximal to the cuff assembly 120. A suction catheter 134 is attached to the proximal end of the suction channel 136 in the hub 110. A vacuum can then be connected to the suction catheter 134 to remove secretions and other liquids that have accumulated proximal to the cuff assembly 102. The suction channel 136 is thus implemented within the tracheotomy tube 100. Suction of secretions from the trachea can be performed periodically or continuously using the suction channel 136.

[0042] 2 is a front view of an exemplary embodiment of a tracheostomy tube 100. As can be seen in FIG. OH is the outer diameter D of the distal segment 112 of the outer cannula 102 ODS Flange 108 extends outwardly between the distal side of hub 110 and the distal segment of outer cannula 102. Sections EE and GG are defined.

[0043] Figure 3 is a cross-sectional view of an exemplary embodiment of the tracheostomy tube 100. This cross-sectional view is along the section line E-E defined in Figure 2 and shows the first inflation line 106a disposed within the first channel 300. The first channel 300 is formed between the inner wall 302b and the outer wall 302a of the outer cannula 102. The channel 300 extends from the proximal side of a flange such as the hub 110 to at least the cuff assembly 102a on the front side of the outer cannula 102. The distal end 306 of the inflation tube 106a extends into the inner cuff 124 through the opening 304 in the outer wall 302a of the outer cannula 102. The inflation tube 106a forms a fluid-tight connection for inflating the inner cuff 102.

[0044] On the rear side of the tracheostomy tube 100, a suction channel is disposed within the wall of the outer cannula. The proximal end 316 of the suction channel 136 is located on the proximal side of the flange 108 and includes an opening for inserting the suction catheter 134 through the passage 314 formed in the hub 110. A vacuum or syringe is connected to the suction catheter 134 for periodic or continuous drainage of the suction channel 136.

[0045] At the distal end of the suction channel 136, an opening 310 is formed in the rear outer wall of the outer cannula 102. This opening 310 is located on the proximal side of the cuff assembly 120. The opening 310 allows secretions and other liquids accumulated around the cuff assembly 120 to flow into the suction channel 136 for drainage. In another embodiment, for example, as described with respect to Figures 7-8, the suction catheter 134 may extend along the length of the suction channel 136 to, or through, the opening 310.

[0046] The stopper 312 is disposed in the channel 136 distal to the opening 310. The stopper 310 seals the suction channel 136 and prevents secretions from flowing to the distal end of the outer cannula 102 and exiting to the lungs. In another embodiment, the suction channel 136 ends distally from the opening 310. For example, the channel 136 is not formed between the outer cannula 102 and the inner cannula 150, and the inner wall 302b of the outer cannula 102 is adjacent to the outer wall 308b of the inner cannula 150.

[0047] The length L of the distal end portion 126 of the tracheostomy tube 100 between the cuff assembly and the main opening 138 DE is at least 10 mm because the length of the cuff assembly 126 is decreasing, and the length L of the distal end DE may be 20 mm or more. At the distal end portion 126, the inner wall 308a of the inner cannula 150 includes a plurality of openings 322 that form part of the secondary ventilation opening 128. The plurality of openings 322 of the inner cannula 150 are substantially aligned with the plurality of openings 130 of the outer cannula 102. For example, when the openings of the openings 322 of the outer wall 308b of the inner cannula 150 are properly aligned, they substantially overlap with the openings of the corresponding openings 130 of the inner wall 302b of the outer cannula 102. Substantially overlapping means that the area of the openings overlaps by at least 80%.

[0048] In one embodiment, each of the openings 322 has an inclined or tilted wall. For example, the wall is angled with respect to the centerline of the distal end portion 126. For example, the inner opening of the opening 130 is distal to the outer opening. The angle of the opening wall can be between 10 degrees and 45 degrees with respect to the centerline of the distal end portion 126. With this configuration, the suction catheter can be smoothly introduced into the inner cannula 150, and the tip of the suction catheter can be prevented from being caught by the inner opening of the opening 130.

[0049] The secondary ventilation opening 128 is disposed on the first side surface of the tracheotomy tube 102, but the plurality of openings 322 may be located on the side surface opposite to the tracheotomy tube 102 or on the front side of the tracheotomy tube 102. Further, the second plurality of openings may be disposed on one or more of the second opposite side surface, the front side, or the rear side. The plurality of openings may be arranged circumferentially around the tracheotomy tube 102 or in other configurations. Further, the diameter of the opening 322 may be large or small depending on the number of the openings 322. The configuration of the opening 322 needs to fully consider the diameter and number of each opening in order to ensure the flow of air necessary for breathing.

[0050] Figure 4 is another cross-sectional view of an exemplary embodiment of the tracheotomy tube 100. This cross-sectional view is along the cross-section line G-G defined in Figure 2 and shows the second inflation line 106b disposed within the second channel 400. The second channel 400 is formed between the inner wall 302b and the outer wall 302a on the front side of the outer cannula 102. The second channel 400 extends from the proximal side of the flange 108 of the hub 110 of the outer cannula 102 to at least the cuff assembly 102. The second inflation line 106b is disposed inside the second channel 400. The distal end 406 of the inflation tube 106b extends into the outer bladder 122 through the sealed opening 404 of the outer wall 402b of the outer cannula 102. The inflation tube 106b forms an airtight fluid connection for inflating the outer bladder 122.

[0051] In this embodiment, two channels 300, 400 are formed in the front wall of the outer cannula 102 to hold the inflation lines 106a, 106b. In another embodiment, the two channels 300, 400 may be formed in the side wall of the outer cannula 102. In yet another embodiment, a single channel may hold both inflation lines 106a, 106b. In still another embodiment, the channels 300, 400 may be formed between the inner cannula 150 and the outer cannula 102, for example, on the front side of the tracheotomy tube 100. Other implementations for arranging the inflation lines 106a, 106b from the proximal side of the flange 108 to the cuff assembly 120 of the tracheotomy tube 100 are also possible.

[0052] FIG. 5A is a diagram showing an exemplary embodiment of the inner cannula 150 of the tracheotomy tube 100. The inner cannula 150 is fitted inside the outer cannula 102 and is removable for replacement and / or cleaning. Similar to the outer cannula 102, the inner cannula 102 includes a distal segment 508, a proximal segment 504, and an intermediate segment 506 coupled between the proximal segment 504 and the distal segment 508. The intermediate segment 506 is curved such that the proximal segment 504 forms an angle of about 80 degrees to about 90 degrees with respect to the distal segment 508. The distal segment 508 includes the main distal opening 138 of the tracheotomy tube 100.

[0053] In this embodiment, the suction channel 136 is formed between the walls of the outer cannula. The inner cannula 150 includes a rear outer wall recess 510 configured to form the upper side of the suction channel 136. The recess 510 is sized to fit over the upper portion of the suction catheter 134.

[0054] In one embodiment, each of the fenestrations 322 of the inner cannula 102 has an angled or tilted wall, e.g., the wall is angled with respect to the centerline of the distal segment 508. For example, the opening of the fenestration 322 of the inner wall 308a is distal to the opening of the fenestration 322 of the outer wall 308b. The angle of the fenestration wall can be between about 10 degrees and about 45 degrees with respect to the centerline of the distal segment 508. This configuration allows the suction catheter to be smoothly introduced into the inner cannula 150 and prevents the tip of the suction catheter from catching on the inner opening of the fenestration 322.

[0055] FIG. 5B is a side view of another exemplary embodiment of the secondary ventilation opening 128 of the tracheostomy tube 100. In another embodiment, to eliminate the need for fenestration alignment, the inner cannula 150 has a plurality of fenestrations 322 and the outer cannula 102 forms a larger lateral opening 520 that exposes the plurality of fenestrations 130 of the inner cannula 150. The lateral opening 522 substantially covers the area over the plurality of fenestrations 322 of the inner cannula 150. For example, the opening 522 exposes at least 90% of the plurality of fenestrations 322 of the inner cannula 150, or the total area of the fenestrations 322 of at least about 20 square mm to about 80 square mm, or other area of the fenestrations necessary to provide sufficient airflow to the patient.

[0056] FIG. 5C is a side view of another exemplary embodiment of the secondary ventilation opening 128 of the tracheostomy tube 100. In another embodiment, instead of a plurality of windows, a plurality of slits 524 may be implemented in the secondary ventilation opening 128. In this embodiment, the inner cannula 150 forms a plurality of slits 524, and the outer cannula 102 forms a side opening 520 that substantially exposes the plurality of slits 524 of the inner cannula 150. The opening 522 covers an area substantially over the plurality of slits 524 of the inner cannula 150. In another embodiment, the outer cannula 102 may also include a plurality of slits that align with the plurality of slits 524 of the inner cannula 150. The plurality of slits 524 may each have an inclined wall or a tilted wall. For example, the inner opening of the slit 524 is distal to the outer opening of the slit 524.

[0057] Thus, the secondary ventilation opening 128 may include a plurality of windows, slits, or other shaped openings formed in the inner cannula 150 and / or the outer cannula 102. For example, the outer cannula 102 may form a plurality of openings that substantially coincide with the plurality of openings formed in the inner cannula 102. In another example, the outer cannula 102 may form at least one large opening that substantially exposes the plurality of openings formed in the inner cannula 102. Other configurations may be implemented such that sufficient airflow is generated for the patient depending on the area of each opening and the number of openings.

[0058] Second Embodiment of the Cuff System FIG. 6 is an elevation view of another exemplary embodiment of the tracheostomy tube 100 having a second exemplary embodiment of the cuff system 120. In this embodiment, the tracheostomy tube 100 does not have an inner cannula 150. For example, the inner cannula 150 has been removed or is not inserted into the outer cannula 102. In another example, some tracheostomy tubes 100 are not designed to include an inner cannula 150.

[0059] In the proximal segment of the tracheostomy tube 100, the flange 108 of the present embodiment comprises two opposing wings extending from the hub 110. The top 602 of the tracheostomy tube 100 is attached to a ventilator. In the distal segment, the main distal opening 138 is formed between the distal bottom surface 140 of the wall 132 of the outer cannula 102. The tracheostomy tube 100 also has a secondary ventilation opening 128 on the side surface of the outer cannula 102 between the cuff assembly 120 and the main distal opening 138. The secondary ventilation opening 128 includes a plurality of openings 130.

[0060] Similar to FIG. 1, the cuff assembly 120 includes an inner cuff 124 and an outer bladder 122. The inner cuff 124 and the outer bladder 122 are more cylindrical, and in this example, the inner cuff 124 is shorter in length than the outer bladder 122. For example, the length L OB of the outer bladder 122 is about 6 mm, and the length L IC of the inner cuff 124 is about 15 mm. The outer bladder 122 includes an upper surface 604 that extends more proximally than the inner cuff 124 to form a collection receptacle, as described in more detail herein.

[0061] The first inflation line 106a includes an inflation balloon 606a attached to a one-way valve for inflating the inner cuff 124. The second inflation line 106b includes an inflation balloon 606b attached to a one-way valve for inflating the outer bladder 122. Thus, the outer bladder 122 and the inner cuff 124 are inflated at different pressures and are configured to maintain those pressures. The relatively elastic inner cuff is configured to operate in an inflated state at a low pressure, for example, in a pressure range of 10 cmH2O to 20 cmH2O. In contrast, the outer bladder, which is less elastic or relatively inelastic, is configured to operate in an inflated state at a high pressure range of 50 cmH2O to 150 cmH2O.

[0062] When in use, for example, when inserted into the trachea and pressurized to an inflated state, the first inner cuff 124 operates as an HVLP-type cuff, and the second outer bladder 122 operates as an LVHP-type cuff. Further, the inflated outer bladder 122 has, for example, fewer wrinkles and folds than an LVHP cuff and forms a relatively smooth surface. The reduction in wrinkles reduces the risk of leakage and forms a more uniform tracheal seal. Thus, the cuff assembly 100 reduces tracheal complications by utilizing an innovative system for titrating the tracheal pressure.

[0063] Embodiments of the Secretion Collection Receptor Patients undergoing mechanical ventilation (MV) experience a physiologically altered environment, such as a decreased ability to remove oral and nasal secretions, a decreased tracheobronchial mucociliary clearance, an increased accumulation of secretions in the lungs and bronchi, a decreased cough reflex, and an increased likelihood of gastric reflux. The combined action of these factors makes patients using a mechanical ventilator more susceptible to ventilator-associated pneumonia (VAP). VAP is a lung infection that usually develops 48 hours after the use of a mechanical ventilator.

[0064] The accumulation of secretions above the tracheostomy cuff in MV patients is a normal physiological phenomenon. The sources of secretions are the oral cavity, paranasal sinuses, and stomach ("orogastric secretions"). In a normal state, it is known that as much as 3 liters of secretions are discharged from the oral cavity and paranasal sinuses per day. Again, this does not include the reflux of gastric juice, which can be a serious problem. Healthy people can remove or manage secretions, but patients wearing a ventilator cannot. Instead, in patients using a ventilator, tracheal secretions accumulate proximal to the tracheostomy cuff or leak into the trachea and lungs beyond the tracheostomy cuff.

[0065] The concern regarding the accumulation of secretions above the tracheostomy cuff is that the secretions contain microorganisms including bacteria and fungi. Since the secretions are highly contaminated, it is necessary to keep them away from the sterile organs of the human body. The lungs are one of such sterile organs. Therefore, it is essential for the treating physician to prevent the secretions from leaking into the patient's lungs.

[0066] The tracheostomy cuff serves as a powerful mechanism for preventing aspiration. When inflated, the tracheostomy cuff contacts the tracheal wall circumferentially and forms a seal that prevents the leakage of body fluids into the lungs. One strategy for combating VAP is to enhance the occlusion function of the tracheostomy cuff. For example, as described herein for the cuff assembly 120, the sealing ability of the tracheostomy cuff is improved, thereby reducing the secretions that leak into the lungs. This method is useful, but if secretions accumulate proximal to the tracheostomy cuff, there is a high likelihood that the secretions will eventually leak into the lungs due to the pressure of the secretions. Therefore, in addition to effective tracheal occlusion, an effective means for removing secretions is also required.

[0067] The current system for removing secretions includes a suction tube at the proximal end of the tracheostomy cuff. However, the configuration of the opening of the suction tube is known to directly damage the tracheal mucosa and cause suction trauma. The opening of the suction tube is configured to be easily blocked by the cuff wall. Also, due to its small size, the suction tube is prone to clogging. Enlarging the suction tube may increase the bulk of the tracheostomy tube and make the intubation process difficult. Also, when the suction tube is integrated with the tracheostomy tube, if the suction tube clogs, it is necessary to replace the entire tracheostomy tube and cuff. Therefore, an improvement in the secretion removal system is required.

[0068] FIG. 7 is a second side view of an exemplary embodiment of a tracheotomy tube 100 having a second exemplary embodiment of a cuff system 120. In this cuff assembly 120, the upper surface 604 of the outer bladder 122 extends proximal to the inner cuff 124 to form a secretion collection receptacle 700. This collection receptacle 700 collects aspirate or other liquids that may accumulate around the proximal end of the cuff assembly 100.

[0069] The suction catheter 702 is disposed within a catheter channel 704 that extends from the proximal end of the tracheotomy tube 100 to at least the receptacle 700. The suction catheter 702 is preferably a thin-walled, non-foldable, flexible hollow channel or tube. In one embodiment, the suction catheter 702 includes a position indicator 706 that provides an indication of the proper position of the suction catheter 702 within the catheter channel 704. The position indicator 706 may include a marking or ridge that serves as a guide to prevent further insertion of the suction catheter 702 into the catheter channel 704.

[0070] The suction catheter 702 is configured to suction the collection receptacle 700 from an opening on the posterior side of the tracheotomy tube 102. As is often seen in intubated patients, when the patient is in a prone position, secretions tend to accumulate on the posterior side of the trachea. Thus, the suction catheter 702 is likely to drain the accumulated secretions through an opening on the posterior side of the receptacle 700. The proximal end of the suction catheter 702 is configured to connect to a vacuum source using an irrigation syringe or a suction tube. When connected, the vacuum source operates continuously or periodically to remove secretions within the receptacle 700. An alarm may be activated when the suction catheter 702 becomes blocked.

[0071] If an occlusion occurs, the suction catheter 702 can be removed from the catheter channel 704 and replaced with a new suction catheter. Thus, the secretions removal system provides an easier way to replace the suction catheter 702 upon occlusion than the current method of replacing the entire tracheostomy tube. The secretions receptacle 700 also helps protect the tracheal wall from suction trauma and direct damage to the tracheal mucosa by the suction catheter 702. The secretions receptacle 700 also helps prevent the cuff 120 from being sucked into the catheter 702. Further, due to the arrangement of the catheter channel 704, a large-diameter suction catheter 702 can be used, reducing the likelihood of occlusion.

[0072] FIG. 8 is a cross-sectional view of an exemplary embodiment of a tracheostomy tube 100 having a second exemplary embodiment of a cuff system 120. In this cuff assembly 120, the upper portion 604 of the outer bladder 122 extends proximal to the inner cuff 124. This upper portion 604 may include an angled inner surface that slopes toward the proximal surface 820 of the inner cuff 124. The bottom of the collection receptacle 700 is defined by the proximal surface 820 of the inner cuff 124, which may be reinforced with a material that is harder and less elastic than other portions of the inner cuff 124. In this way, the upper surface 820 of the inner cuff and the upper portion 604 of the outer bladder form the collection receptacle 700.

[0073] The catheter channel 704 extends from the proximal end of the tracheostomy tube 100 at least to the collection receptacle 700. The catheter channel 704 is formed by an inner wall 804 disposed within the tracheostomy tube 100 and an outer wall 806 of the tracheostomy tube 100. The catheter channel 704 of this embodiment is disposed on the posterior side of the tracheostomy tube 100 and is configured to accommodate the suction catheter 702. For example, the outer diameter of the suction catheter 702 is about 4 mm. The inner diameter of the suction channel 704 is greater than 4 mm, for example, about 4.1 to about 4.5 mm, so that the suction catheter 702 can slide within the catheter channel 704 during removal and / or insertion of the suction catheter 702.

[0074] On the outer wall 806 on the rear side of the tracheotomy tube 100, a rear opening 802 from the catheter channel 704 to the receptacle 700 is formed. The distal end of the suction catheter 702 can extend into the receptacle 700 through the rear opening 802. The catheter channel 704 may include an inclined surface 814 formed, for example, by the inner wall 804 at the distal end adjacent to the opening 802. The inclined surface 814 helps to guide and position the distal end of the catheter 702 through the opening 802. In this way, the suction catheter 702 discharges body fluid from the receptacle 700 and prevents the body fluid from leaking into the patient's lungs.

[0075] The inflation line 106a is arranged from the proximal end of the tracheotomy tube 100 to the inner cuff 124. The inflation line 106a may be attached to the inner wall of the tracheotomy tube 100 using an adhesive or other means, or may be arranged in a predetermined channel. On the outer wall 806 of the tracheotomy tube 100, an opening 812 is formed for the distal end 810 of the inflation line 106a to access the inner cuff 124. A similar configuration may be implemented for the inflation line 106b to access the outer bladder 122.

[0076] Figures 9A - C are block diagrams of cross - sectional views of an embodiment of the cuff system 120. Referring to Figure 9A, a cuff system 120 including an inner cuff 124 and an outer bladder 122 is shown. The outer bladder 122 is a self - contained structure and has, for example, a wall separate from the inner cuff 124. The outer bladder 122 includes an inner surface 902a and an outer surface 902b. The inner surface 902a of the outer bladder 122 is disposed adjacent to the outer surface 904b of the inner cuff 124 and can be attached to the outer surface 904b of the inner cuff 124 using, for example, one or more of an adhesive, heat, or other means. The inner surface 904a of the inner cuff 124 is adjacent to and attached to the outer cannula 102 of the tracheostomy tube 100. The inner surface 902a of the outer bladder 122 is proximate to and / or attached to the outer surface 904b of the inner cuff 124 using, for example, an adhesive, heat, or other means. Additionally or alternatively, a band 808 can be attached to the tracheostomy tube 102 and extend at least to the inner cuff 124. The band 808 can also be attached to the outer bladder 122.

[0077] In this embodiment of the cuff assembly 120, the length L of the outer bladder 122 OB and the length L of the inner cuff 124 IC are approximately equal. For example, when inflated, the length L of the inner cuff 124 IC is about 15 mm, and the length L of the outer bladder 122 OB (without the upper portion 604) is about 15 mm. In another embodiment, the length L of the outer bladder 122 OB and the length L of the inner cuff 124 IC may be different. For example, the length L of the outer bladder (including the upper portion 604) OB is about 15 mm, and the length L of the inner cuff 124 IC may be about 6 mm. Further, in one embodiment, the width W of the outer bladder OB and the width W of the inner cuff IC are approximately equal. For example, the width W of the outer bladder OB and the width W of the inner cuff IC are about 6 mm. In other embodiments, the width of the outer bladder W OB or the width of the inner cuff W ICThe widths may be different. For example, the inner cuff 124 may be wider or narrower than the outer bladder 122. The thicknesses of the inner cuff 124 and the outer bladder 122 can be 0.00086 inches (0.022 mm) or less. These dimensions are exemplary, and the cuff assembly 120 may be implemented with other dimensions.

[0078] To form the collection receptacle 700, the upper portion 604 of the outer bladder 122 extends proximally from the inner cuff 124 and is angled inwardly to form a groove. The length of the upper portion 604 from the proximal surface 820 of the inner cuff 124 can be from about 2 mm to about 15 mm. The receptacle 700 may extend from about 90 degrees to about 180 degrees on the posterior side of the cuff assembly 120 or may extend 360 degrees around the tracheostomy tube 100. The upper portion 604 is attached to the proximal surface 820 of the inner cuff 124 and / or to the tracheostomy tube 100. Thereby, leakage between the inner cuff 124 and the outer bladder 122 is prevented. The upper portion 604 of the outer cuff 122 may include a rigid PVC sheet that seals against the tracheal wall and allows secretions to flow into the well. The rigid PVC sheet also helps prevent leakage of secretions.

[0079] Alternatively or additionally, the inner cuff 124 may be attached to form a seal against leakage or may be pressed against the outer bladder 122 so that secretions or other substances do not leak from the joint. For example, the inner cuff 124 and the outer bladder 122 can be attached using an adhesive, a heating process, or a combination thereof to form a seal to prevent leakage.

[0080] Furthermore, the inner surface 904a of the inner cuff 124 is sealed to, attached to, or pressed against the outer wall 806 of the tracheostomy tube 100 to prevent leakage. For example, the inner cuff 124 and the tracheostomy tube 100 can be attached using an adhesive, a heating process, or a combination thereof. This sealing and attachment prevents leakage of secretions between the tracheostomy tube 100 and the inner cuff 124.

[0081] FIG. 9C shows another embodiment of a cuff system 120 in which a different structure 910 is attached to a tracheostomy tube to form a secretion collection receptacle 700. The structure 910 is disposed proximal to the cuff assembly 120 and is attached to the tracheostomy tube 100. Alternatively or additionally, the structure 920 may be attached to the upper proximal surface of the inner cuff 102 and / or the upper proximal surface of the outer bladder.

[0082] The configurations shown in FIGS. 9A - C are exemplary, and other configurations for forming the collection receptacle 700 may be implemented.

[0083] Embodiments of a pressure adjustment system The advantages and risks of a tracheostomy tube lie in maintaining a predetermined pressure range within the cuff assembly 120 rather than in the tube itself. For example, over - inflation of the cuff assembly 120 can cause ischemic injury and vocal cord nerve injury, potentially leading to tracheal mucosal injury. This injury occurs when a certain pressure is exerted by the cuff, preventing blood flow to the tracheal mucosa. This lack of blood can potentially lead to tissue necrosis. Additionally, the cuff may rub against the tracheal wall repeatedly, causing damage. If the cuff assembly 120 is under - inflated and the tracheal seal is insufficient, the patient may not receive sufficient oxygen. Furthermore, the patient is at a higher risk of pneumonia due to aspiration of gastric contents. Therefore, maintaining the pressure of the cuff assembly 120 of the tracheostomy tube 100 is an important element of patient care from the perspective of reducing tracheal injury and preventing ventilator - associated pneumonia (VAP).

[0084] Currently, several types of automatic cuff pressure regulators are available. These current devices monitor the pressure within a single cuff. However, upon closer examination, it can be seen that this approach has significant drawbacks. The pressure within the cuff does not reflect the exact pressure exerted on the tracheal wall. Ultimately, it is the tracheal wall pressure that determines both the risks and advantages of the cuff. Therefore, an improved system and method for monitoring and adjusting cuff pressure are needed.

[0085] Figure 10 is a block diagram of an embodiment of a tracheostomy tube 100 having a plurality of pressure sensors 1000. The first pressure sensor 1000a can be disposed within the inner cuff 124 or at the proximal end of its air tube (not shown) to measure the air pressure within the inner cuff 124. The second pressure sensor 1000b is disposed inside the outer bladder 122 or at the proximal end of its air tube (not shown) to measure the air pressure within the outer bladder. One or more pressure sensors 1000c, 1000d may be disposed on the outer surface of the outer bladder 122 to measure the pressure applied by the cuff assembly to the tracheal wall ("intratracheal pressure"). Additionally or alternatively, a pressure sensor 1000e may be disposed between the outer bladder 122 and the inner cuff 124t to measure the intratracheal pressure.

[0086] The pressure adjustment system monitors the intratracheal pressure using one or more pressure sensors 1000c, d on the outer bladder surface and / or a pressure sensor 1000e between the inner cuff 124 and the outer bladder 122. For example, since the force of the inner cuff 124 acts radially on the outer bladder 122, it ultimately becomes the force acting on the tracheal wall as the intratracheal pressure. The cuff - to - cuff pressure sensor 1000e is disposed between the inner cuff 124 and the outer bladder 122, so it measures the radial force of the inner cuff 124 on the outer bladder 122. Thus, the pressure sensor 1000e measures the intratracheal pressure, such as the pressure applied by the cuff assembly 102 to the tracheal wall.

[0087] The pressure sensor 1000 transmits the pressure measurement value to the pressure adjustment system. The pressure sensor 1000 may include a wireless transmitter such as a near - field or radio - frequency identification (RFID) transmitter or an Internet of Things (IoT) cellular - type transmitter. The pressure sensor can wirelessly transmit the pressure measurement value to the pressure adjustment system using the wireless transmitter.

[0088] An additional pressure sensor device may be disposed within the tracheostomy tube 100 or at the tip of the tracheostomy tube 100 to measure the pressure of the oxygen - containing air supplied to the patient.

[0089] FIG. 11 is a schematic block diagram of an exemplary embodiment of a pressure regulator and control system (a "regulator system") 1100 for a cuff assembly 120. The regulator system 1100 is in fluid communication with the cuff assembly 120, for example, when the tracheotomy tube 100 is placed in a patient's trachea, to inflate and adjust the pressure within the cuff assembly 120. The pressures of the inner cuff 124 and the outer bladder 122 of the cuff assembly 120 are monitored and controlled separately.

[0090] The regulator system 1100 includes a pressure controller 1108 and a pneumatic system 1120. The pressure controller 1108 includes a processor device 1110 and a memory device 1112. The memory device 1112 includes one or more non-transitory processor-readable memories that store instructions that, when executed by the processor device 1110 or other components of the regulator system 1100, cause the regulator system 1100 to perform one or more of the functions described herein. The processor device 1110 includes at least one processing circuit such as a microprocessor, a microcontroller, a digital signal processor, a microcomputer, a central processing unit, a field programmable gate array, a programmable logic device, a state machine, a logic circuit, an analog circuit, a digital circuit, and / or any device that operates on signals (analog and / or digital) based on circuits and / or hard coding of operating instructions. The memory device 1112 includes a non-transitory memory device, which may be an internal memory or an external memory, and may be a single memory device or a plurality of memory devices. The memory device 1112 may be a read-only memory, a random access memory, a volatile memory, a non-volatile memory, a static memory, a dynamic memory, a flash memory, a cache memory, and / or any non-transitory memory device that stores digital information.

[0091] The pressure controller 1108 may be arranged together with the pneumatic system 1120 within the same physical device, or may be separately arranged within another device or case. The pressure controller 1108 further includes a user interface 1114. The user interface 1114 generates user input / output (I / O) and includes one or more of a display, keyboard, touch screen, mouse, touch pad, gauge, switch, or other I / O devices.

[0092] In use, in response to user input received by the user interface 1114, a desired predetermined pressure setting for the cuff assembly 120 is determined by the pressure controller 1108. Alternatively, a default pressure setting may be implemented, such as when there is no user input.

[0093] Different pressure settings can be set for the inner cuff 124 and the outer bladder 122. The set pressure can be a predetermined pressure or pressure range, for example, typically within plus or minus 2 cmH2O. For example, the pressure setting of the inner cuff 124 can be a pressure of 10 cmH2O to 20 cmH2O (plus or minus 2 cmH2O). In contrast, the pressure setting of the outer inflation bladder can be a pressure of 50 cmH2O to 150 cmH2O (plus or minus 2 cmH2O). Thus, the inner cuff 124 operates in a lower pressure range than the operating pressure range of the outer bladder 122. The pressure controller 1108 further determines the frequency of measuring and adjusting the pressure of the cuff assembly 120, for example, depending on either user input or a default setting.

[0094] The pneumatic system 1120 has a first pneumatic path for the outer bladder 122, which includes, for example, a first air pump 1122a and a discharge valve 1124a that are in fluid communication with the outer bladder 122 via an output port 1126a, a one-way valve, a pilot balloon, and an inflation line 106b. The pneumatic system 820 further has another second pneumatic path for the inner cuff 124, which includes, for example, a second air pump 1122b and a discharge valve 1124b that are in fluid communication with the inner cuff 124 via an output port 1126b, a one-way valve, a pilot balloon, and an inflation line 106a. Although two air pumps 1122a, 1122b are described herein, for example, a valve or switch may be used between the two fluid paths to supply pressurized air to the inner cuff 124 and the outer bladder 122 with a single air pump. Thus, the pneumatic system 1120 includes separate pneumatic paths that independently and separately fluidly increase and decrease the pressures of the air cuff 104 and the outer bladder 122.

[0095] During operation, the pressure controller 1108 receives pressure measurements from one or more pressure sensor devices 1000 and adjusts the pressure of the cuff assembly 120. For example, the inter-cuff pressure sensor device 1000e is disposed between the inner cuff 124 and the outer bladder 122 and measures the radial force of the inner cuff 124 with respect to the outer bladder 122. To measure the pressure within the inner cuff 124, the inner cuff pressure sensor device 1000a can be disposed within the inner cuff 124. To measure the pressure within the outer bladder 122, the outer bladder pressure sensor device 1000b can be disposed. Additional outer cuff assembly pressure sensor devices 1000c and / or 1000d can be disposed on the outer surface of the outer bladder 122 to measure the intratracheal pressure. Also, additional pressure sensor devices may be implemented. The pressure sensor devices generate pressure measurements and communicate with the pressure controller 1108, for example, via wired leads and / or a wireless transmitter.

[0096] Pressure regulator system 1100 includes a pressure feedback loop in which a pressure controller 1108 controls a pneumatic system 1120 to adjust the pressures of both an inner cuff 124 and an outer bladder 122 in response to a pressure measurement value. The pressures of the inner cuff 124 and the outer bladder 122 are monitored and controlled separately. The pressure controller 1108 sends a signal to the pneumatic system 1120 to add or release air to / from the outer bladder 122 and / or the inner cuff 124. For example, to adjust the pressure in the outer bladder 122, the pressure controller 1108 can send a signal to an air pump 1122a to add air to the outer bladder 122 or to a release valve 1124a to release air from the outer bladder 122. In another example, to adjust the pressure in the inner cuff 124, the pressure controller 1108 can send a signal to an air pump 1122b to add air to the inner cuff 124 or to a release valve 1124b to vent air from the inner cuff 124.

[0097] Regulator system 800 monitors a pressure measurement value and automatically adjusts, first, the pressure of the outer bladder 122 and, second, the pressure of the inner cuff 124 to a predetermined pressure that is, for example, preselected by an operator or set by default. The pressure controller 1108 may continuously monitor and regulate the pressure of the cuff assembly 120 or may monitor and regulate the pressure at predetermined intervals. The regulator system 1100 may further include a visual and / or audible alarm if the pressure measurement value is not safe.

[0098] FIG. 12 is a flowchart of an embodiment of one or more methods 1200 for monitoring and controlling the pressure of the cuff assembly 120. At step 1202, one or more pressure measurement values regarding the tracheal wall pressure are obtained from one or more pressure sensor devices 1000 by the regulator system 1100. Using these pressure measurement values, at step 1204, the regulator system 1100 determines whether the intratracheal pressure, for example, the pressure exerted by the cuff assembly 120 on the tracheal wall, is within a predetermined pressure range. The pressure measurement can be performed from the cuff - to - cuff pressure sensor device 1000e between the inner cuff 124 and the outer bladder 122, and / or from one or more pressure sensors 1000c - d disposed on the outer surface of the outer bladder 122. When the intratracheal pressure exceeds the predetermined pressure range, the regulator system 1100, at step 1106, reduces at least the pressure within the inner cuff 124. For example, the regulator system 1100 can control the release valve 1124b to release air from the inner cuff 124. Since the blood flow in the tracheal mucosa can be impaired at pressures exceeding 30 cmH2O (22 mmHg), when the measured intratracheal pressure exceeds 30 cmH2O (22 mmHg), the regulator system 1100 may reduce at least the pressure of the inner cuff 124.

[0099] If the intratracheal pressure is less than the predetermined pressure range, the regulator system 1100, at step 1206, increases at least the pressure within the inner cuff 124. For example, the regulator system 1100 can control the air pump 1122b to send air into the inner cuff 124. Additionally, the pressure of the outer bladder 122 can also be adjusted. These steps may be executed at preset intervals or continuously.

[0100] In step 1208, the regulator system 1100 obtains one or more pressure measurement values related to the outer bladder pressure from one or more pressure sensor devices. Using these pressure measurement values, in step 1210, the regulator system 1100 determines whether the pressure of the outer bladder 122 is within a predetermined pressure range. For example, the pressure measurement can be from a pressure sensor device 1000b installed inside the outer bladder 122 or in the pilot balloon of the inflation line 106b of the outer bladder 122. If the outer bladder pressure is below or above the predetermined pressure range, the regulator system 1100 increases or decreases the pressure inside the outer bladder 122 in step 1212. For example, the regulator system 800 can control the air pump 1122a to send air into the outer bladder 122 when the pressure is lower than the predetermined pressure range, and control the discharge valve 1124a to release air from the outer bladder 122 when the pressure is higher than the predetermined pressure range.

[0101] In step 1214, the regulator system 1100 obtains one or more pressure measurement values related to the inner cuff pressure from one or more pressure sensor devices. Using these pressure measurement values, in step 1216, the regulator system 1100 determines whether the pressure of the inner cuff 124 is within a predetermined pressure range. For example, the pressure measurement can be from a pressure sensor device 1000a installed inside the inner cuff 124 or in the pilot balloon of the inflation line 106a of the inner cuff 124. If the inner cuff pressure is below or above the predetermined pressure range, the regulator system 1100 can increase or decrease the pressure inside the inner cuff 124 in step 1218. For example, the regulator system 1100 can control the air pump 1122b to send air into the inner cuff 124 when the pressure is lower than the predetermined pressure range, and control the discharge valve 1124b to release air from the inner cuff 124 when the pressure is higher than the predetermined pressure range. The inner cuff is a low-pressure inflation cuff, and the predetermined pressure range can be 10 cmH2O to 20 cmH2O.

[0102] In this way, the pressures of the inner cuff 124 and the outer bladder 122 of the cuff assembly 120 are individually controlled using separate pneumatic paths, such as separate air pumps 1122 and / or discharge valves 1124, and separate air inflation tubes 106a, 106b. The pressure of the less elastic outer bladder 122 is maintained at a higher pressure than the pressure of the more elastic inner cuff. The pressure controller 1110 can also independently adjust the pressures of the inner cuff 124 and / or the outer bladder 122 to adjust the intratracheal pressure.

[0103] Accordingly, the cuff assembly 120 and the regulator system 1100 help reduce pulmonary microaspiration and infection without overly damaging the tracheal wall while maintaining a good seal with the tracheal wall. This system enhances the airway seal and minimizes damage to the airway.

[0104] The tracheostomy tube 100 described herein includes a novel secondary ventilation opening 128 for reducing the risk of occlusion, an improved cuff assembly 120, and an effective secretion collection and removal system. The cuff assembly 120 includes a toroidal outer bladder 122 and an inner cuff 124. The inner cuff is made of a relatively elastic material and operates at a low pressure. The outer bladder 122 includes a relatively less elastic material and operates at a high pressure to achieve full inflation for an optimal tracheal seal.

[0105] The outer bladder 122 can also be configured to form a collection receptacle 700 above the cuff system 120. Accumulated body secretions are discharged from the receptacle 700 via a suction channel.

[0106] The novel cuff system 120 disclosed herein further enables the length of the cuff to be significantly smaller than that of current tracheostomy cuffs. Shortening the length of the cuff ensures sufficient space in the distal segment of the tracheostomy tube 100 and allows for the formation of a secondary ventilation opening 128 in the distal sidewall of the tracheostomy tube 100. The secondary ventilation opening 128 provides an alternative means for respiration in the event that the main opening 138 of the tracheostomy tube 100 becomes blocked. Without the secondary ventilation opening 128, the tracheostomy tube 100 could become occluded, leading to fatal consequences. The tracheostomy tube 100 comprising the secondary ventilation opening 128, the improved cuff assembly 120, and an effective secretion drainage system, disclosed herein, significantly improves patient safety and health.

[0107] As used herein, the terms "operable to" or "configured to" mean that an element includes one or more of components, dimensions, circuits, instructions, modules, data, inputs, outputs, etc. for performing one or more of the corresponding functions described or required, and may further include inferential couplings to one or more other items for performing the corresponding functions described or required. As used herein, the terms "coupled," "coupled to," "connected," and / or "connecting" or "interconnecting" include direct connections or links between components or nodes / devices, and / or indirect connections between components or nodes / devices through intervening items. Further, as used herein, inferred connections (i.e., when one element is inferred to be connected to another element) include both direct and indirect connections between two articles, similar to "connected." The terms "substantially" and "about" as used herein provide an industry-recognized tolerance for the relativity between the corresponding terms and / or items.

[0108] Note that aspects of the present disclosure may be described herein as a process depicted as a schematic diagram, flowchart, flow diagram, structural diagram, or block diagram. Although operations are described in a flowchart as sequential processes, many operations can be performed in parallel or concurrently. Additionally, the order of operations can be rearranged. A process terminates when its operations are completed. A process corresponds to a method, function, procedure, subroutine, subprogram, etc. When a process corresponds to a function, its termination corresponds to the return of the function to the calling function or main function.

[0109] The various features of the present disclosure described herein can be implemented in different systems and devices without departing from the present disclosure. Note that the above-described aspects of the present disclosure are merely illustrative and should not be construed as limiting the present disclosure. The description of the aspects of the present disclosure is intended for illustration and not for limiting the scope of the claims. Accordingly, the present teachings can be readily applied to other types of devices, and many alternatives, amendments, and variations will be apparent to those skilled in the art.

[0110] In the foregoing specification, specific representative aspects have been described with reference to specific examples. However, various modifications and changes can be made without departing from the scope of the invention as set forth in the claims. The present specification and drawings are illustrative rather than restrictive, and variations are intended to be included within the scope of the claims. Accordingly, the scope of the claims should be determined not by the mere examples described, but by the description herein and their legal equivalents. For example, the components and / or elements recited in any apparatus claim may be assembled in various permutations or otherwise operably configured, and thus are not limited to the specific configurations recited in the claims.

[0111] Furthermore, although specific advantages, other advantages, and solutions to problems have been described above with respect to specific embodiments, any advantage, effect, solution to a problem, or any element that may cause or make more prominent any specific advantage, effect, or solution should not be construed as an important, essential, or essential feature or component of any or all of the claims.

[0112] As used herein, the terms "comprise," "comprises," "comprising," "having," "including," "includes," or variations thereof are intended to refer to non-exclusive inclusion, such that a process, method, article, composition, or apparatus that includes a list of elements does not include only those elements but may also include other elements not expressly listed or elements inherent to such a process, method, article, composition, or apparatus. The above-described structures, arrangements, uses, ratios, elements, materials, or other combinations and / or modifications of components used in the implementation of the present invention, in addition to those not specifically described, may be varied or otherwise specifically adapted according to particular environments, manufacturing specifications, design parameters, or other operating requirements without departing from its general principles.

[0113] Furthermore, references to elements in the singular are not intended to mean "sole" unless expressly stated otherwise, but rather "one or more." Unless expressly stated otherwise, the term "some" refers to one or more. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known to those of ordinary skill in the art or become known to those of ordinary skill in the art later are hereby expressly incorporated by reference and are intended to be included within the scope of the claims. Additionally, what is disclosed herein is not intended to be dedicated to the public regardless of whether such disclosure is expressly recited in the claims. A claim element should not be construed as a "means-plus-function" type element under 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for."

Claims

1. In a tracheostomy tube, an outer cannula of the tracheostomy tube including a distal segment, the distal segment including a main distal opening, the outer cannula, and a cuff assembly of the tracheostomy tube in the distal segment of the outer cannula, an inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the outer cannula and having a first elasticity, the inner cuff, and an inflatable outer bladder disposed adjacent to the outer surface of the inner cuff and having a second elasticity smaller than the first elasticity of the inner cuff, a cuff assembly including the outer bladder, wherein a distal segment of the outer cannula of the tracheostomy tube forms a secondary ventilation opening between the cuff assembly and the main distal opening, and the secondary ventilation opening between the cuff assembly and the main distal opening of the tracheostomy tube has a total area sufficient to maintain an air flow for a patient's respiration, remains open, and is configured to function as a conduit for both inspiration and expiration to flow during ventilation. A tracheostomy tube.

2. The length L of the cuff assembly ＣＡ is from 10 millimeters (mm) to 20 mm, and the secondary ventilation opening is formed in a side wall of a distal segment of the outer cannula between the cuff assembly and the main distal opening and has a total area of at least 20 square mm, the tracheostomy tube according to claim 1.

3. The tracheostomy tube according to claim 1, wherein the secondary ventilation opening includes a plurality of openings formed in a side wall of a distal segment of the outer cannula between the cuff assembly and the main distal opening.

4. The tracheostomy tube according to claim 3, wherein each of the plurality of openings has an inclined wall, and an inner opening of each of the plurality of openings is distal to an outer opening of each of the plurality of openings.

5. The tracheostomy tube according to claim 1, wherein the secondary air flow opening functions as a main conduit through which air flows from the patient to the ventilator and from the ventilator to the patient when the main distal opening of the tracheostomy tube is blocked.

6. Furthermore, the tracheostomy tube according to claim 1, further comprising an inner cannula disposed inside the outer cannula, the inner cannula forming a first plurality of openings.

7. The secondary ventilation opening formed in the outer cannula The tracheostomy tube according to claim 6, further comprising at least one opening that substantially exposes a plurality of openings formed in the inner cannula.

8. The secondary ventilation opening formed in the outer cannula The tracheotomy tube according to claim 6, comprising a plurality of second openings formed in the outer cannula and substantially aligned with the plurality of first openings formed in the inner cannula.

9. The tracheotomy tube according to claim 1, further comprising a suction channel formed inside the tracheotomy tube, the suction channel including a distal end proximate to the proximal side of the cuff assembly and a proximal end of the suction channel at the proximal end of the tracheotomy tube, wherein the proximal end of the suction channel is in fluid communication with a vacuum.

10. Furthermore, a pressure regulator, adjusting the first pressure in the inner cuff within a first pressure range of 10 cmH2O to 20 cmH2O using a first pneumatic path, The tracheotomy tube according to claim 1, comprising a pressure regulator configured to adjust a second pressure in the outer bladder within a second pressure range of 50 cmH2O to 150 cmH2O using another second pneumatic path.

11. In a tracheotomy tube, a cuff assembly of the tracheotomy tube, the cuff assembly having a length of 20 mm or less, an inflatable inner cuff having an inner surface and an outer surface, an inflatable outer bladder disposed adjacent to the outer surface of the inner cuff, the outer bladder having a second elasticity smaller than the first elasticity of the inner cuff, an outer cannula of the tracheotomy tube, the outer cannula having a main distal opening, wherein the inner surface of the cuff assembly is disposed adjacent to the outer cannula, and the outer cannula has a length of at least 10 mm between the cuff assembly and the main distal opening, the tracheotomy tube, wherein the outer cannula forms a secondary ventilation opening between the cuff assembly and the main distal opening, and the secondary ventilation opening is configured to remain open during ventilation.

12. The tracheotomy tube according to claim 11, wherein the secondary ventilation opening is formed in a side wall of a distal segment of the outer cannula between the cuff assembly and the main distal opening and has a total area of at least 20 square mm sufficient to maintain an air flow for a patient's respiration.

13. Furthermore, an inner cannula disposed inside the outer cannula, the inner cannula forming a plurality of first openings. The secondary airflow opening in the outer cannula includes a second plurality of openings, and the second plurality of openings in the outer cannula are substantially aligned with the first plurality of openings in the inner cannula. The tracheostomy tube according to claim 11.

14. A first inflation channel formed in the wall of the outer cannula, extending at least from the flange of the outer cannula to the cuff assembly, and having a first inflation line disposed therein for inflating the inner cuff. A first inflation channel; A second inflation channel formed in the wall of the outer cannula, extending at least from the flange of the outer cannula to the cuff assembly, and having a second inflation line disposed therein for inflating the outer bladder. A second inflation channel; A pressure regulation system, Using the first inflation channel to add or remove air from the inner cuff to maintain a first pressure range within the first pressure range of the inner cuff, A pressure regulation system configured to add or remove air from the outer bladder using the second inflation channel to maintain a second pressure range within the outer bladder. The tracheostomy tube according to claim 11.

15. The inner cuff includes a relatively elastic material, and the relatively elastic material includes one or more of rubber, silicone, latex, polyvinyl chloride (PVC), neoprene, polyisoprene, or polyurethane (PU). The outer bladder includes a relatively low-elasticity material, and the relatively low-elasticity material includes one or more of polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU). The tracheostomy tube according to claim 11.

16. The length of the inner cuff is 10 mm to 20 mm, and the length of the outer bladder is 5 mm to 9 mm. The tracheostomy tube according to claim 11.

17. In a tracheostomy tube configured to fit within the trachea, A cuff assembly including at least one inflatable cuff, An outer cannula having a main distal opening, wherein an inner surface of the cuff assembly is disposed adjacent to the outer cannula, and the outer cannula forms at least one secondary ventilation opening between the cuff assembly and the main distal opening, the outer cannula, An inner cannula disposed inside the outer cannula, the inner cannula forming a first plurality of openings, and at least one secondary air flow opening of the outer cannula substantially exposing the first plurality of openings of the inner cannula, a tracheostomy tube characterized by comprising an inner cannula.

18. The secondary ventilation opening formed in the outer cannula is At least one opening substantially exposing the plurality of openings formed in the inner cannula, or The tracheostomy tube according to claim 17, comprising a second plurality of openings formed in the outer cannula and substantially aligned with the first plurality of openings formed in the inner cannula.

19. The tracheostomy tube according to claim 17, wherein the secondary ventilation opening is formed in a side wall of the outer cannula between the cuff assembly and the main distal opening and has a total area of at least 20 square mm sufficient to maintain an air flow for a patient's breathing.

20. The tracheostomy tube according to claim 17, wherein the outer cannula has a length of at least 10 mm between the cuff assembly and the main distal opening.

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