Systems and methods for endotracheal tube cuff assembly

Abstract

A cuff assembly for an airway cannula includes an outer bladder and an inner cuff. The inner cuff is positioned adjacent to the airway cannula, and the outer bladder is positioned adjacent to the inner cuff. The outer bladder is made of a less elastic material and operates at higher relative pressures. The inner cuff is made of a more elastic or super-elastic material and operates at lower relative pressures. A pressure controller independently regulates the pressure within the inner cuff and the outer bladder. A secretion collection reservoir is formed by the cuff assembly and is evacuated via a suction conduit or channel.

Description

[0001] CLAIM OF PRIORITY

[0002] This application claims priority to and the benefit of U.S. Patent Application No. 17 / 848,273, filed on June 23, 2022, in the U.S. Patent Office, the entire contents of which are incorporated herein by reference as if fully set forth below in their entirety and for all applicable purposes. TECHNICAL FIELD

[0003] The present application relates to systems and methods for cuff assemblies implemented in medical devices, and more particularly, to cuff assemblies implemented within airway tubes, pressure adjustment systems for cuff assemblies, and secretion removal systems. BACKGROUND

[0004] Currently, there are two main types of cuffs: low volume high pressure (LVHP) cuffs and high volume low pressure (HVLP) cuffs. The first type of LVHP cuff is made of a relatively inelastic material that is stiffer. Due to its inherent stiffness, higher pressure levels (50 cm H2O to 100 cm H2O) are required to inflate the LVHP cuff. As a result, the LVHP cuff creates excessively high pressure on the tracheal mucosa, even when inflated to the minimum pressure to form a seal with the tracheal wall. This high pressure leads to an unacceptably high incidence of tracheal ischemia and necrosis, for example, 5% to 20% incidence. Despite this, a key advantage of the LVHP cuff when inflated is the relative absence of folds or wrinkles, resulting in excellent tracheal sealing. LVHP cuffs were first used in the mid-1960s, but have now been widely replaced by HVLP cuffs.

[0005] HVLP cuffs are composed of a more elastic and compliant material that inflates at lower pressures. To compensate for the lower pressure characteristics and form a seal against the tracheal wall, the diameter of the HVLP cuff is typically 1.5 to 2 times the diameter of the trachea when fully inflated. However, the increased volume of the HVLP cuff requires a significant amount of cuff material, which increases the bulk of the HVLP cuff, making intubation more difficult. In addition, the excess material has a tendency to form wrinkles or folds due to “incomplete inflation.” These wrinkles or folds often create a pathway for orogastric secretions to pass through the HVLP cuff, ultimately leading to microaspiration and lung infection.

[0006] In examining the effects of cuff pressure on the trachea, it is important to remember that the tracheal wall mucosal capillary perfusion pressure in humans is in the range of 22 to 32 mm Hg, and tracheal mucosal blood flow can be compromised at applied pressures above 30 cm H2O (22 mm Hg), with blood flow to certain sections completely occluded at 50 cm H2O (37 mm Hg). Thus, it is clear that there is only a small overlap between the safe pressure range and the complication pressure range. In fact, the window of effectiveness and safety is very narrow, or even nonexistent.

[0007] The pressure required for a typical HVLP cuff to achieve reasonable distention with an acceptable number of folds or wrinkles is about 32 cm H20. Guidelines established by various medical associations and organizations recommend maintaining the pressure of an HVLP cuff in the range of 20 cm H20 to 30 cm H20 to avoid occluding blood flow to the tracheal mucosa. However, even with strict adherence to these recommendations, many patients remain at risk. In fact, one study showed that about 10% of patients receiving mechanical ventilation develop ventilator-associated pneumonia (VAP), which has an estimated mortality rate of 13%. Moreover, patients with VAP require longer hospital stays and incur higher medical costs compared to patients with similar conditions who do not develop VAP. Given that about 7.5 million patients in the United States require a ventilator each year, the human and economic toll of VAP is enormous.

[0008] Unfortunately, studies have shown that micro-aspirations occur with HVLP cuffs even at pressures as high as 60 cm H20, which indicates that wrinkles persist with the cuff even at higher pressures, allowing secretions to pass through. Thus, even though HVLP cuffs exhibit superiority due to their ability to create a seal at lower pressure levels and avoid necrosis of the tracheal wall, they are still far from ideal.

[0009] While the primary goal of providing the greatest airway seal with the least damage to the airway is simple enough to understand, achieving this goal has proven to be difficult. Despite various modifications and improvements to materials, shape, and volumetric structure, breakthroughs in achieving this goal have remained elusive. Thus, there is a need for an improved cuff system that helps reduce micro-aspirations and lung infections by maintaining a good seal with the tracheal wall while avoiding excessive damage to the tracheal wall. SUMMARY

[0010] In one aspect, a medical device includes an airway cannula configured to fit within a trachea and a cuff assembly implemented at a distal end portion of the airway cannula. The cuff assembly includes an inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned proximate to the airway cannula, and wherein the inner cuff has a first elasticity. An inflatable outer bladder is positioned proximate to the outer surface of the inner cuff, wherein the outer bladder has a second elasticity that is less than the first elasticity of the inner cuff.

[0011] In another aspect, a cuff assembly for a tracheal airway tube includes an inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned proximate the tracheal airway tube, and wherein the inner cuff is configured to inflate at a first pressure range. The cuff assembly further includes an inflatable outer bladder positioned proximate the outer surface of the inner cuff, wherein the outer bladder is configured to inflate at a second pressure range, wherein the first pressure range is lower than the second pressure range.

[0012] In another aspect, a medical device includes an airway tube configured to fit within a trachea and a cuff assembly implemented at a lower end of the airway tube. The cuff assembly includes an inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned proximate the airway tube, and wherein the inner cuff has a first elasticity. The cuff assembly further includes an inflatable outer bladder positioned proximate the outer surface of the inner cuff, wherein the outer bladder has a second elasticity that is less than the first elasticity of the inner cuff. The medical device further includes a pressure regulator configured to set a first pressure for the inner cuff and a second pressure for the outer bladder, wherein the first pressure for the inner cuff is less than the second pressure for the outer bladder.

[0013] In one or more of the above aspects, a secretion removal system for an airway tube includes a secretion collection container at a proximal end of a cuff assembly, wherein the cuff assembly is disposed about a circumference of the airway tube. The system further includes an aspiration channel including a distal end proximate the secretion collection container and a proximal end of the aspiration channel at a proximal end of the airway tube, wherein the proximal end of the aspiration channel is in fluid communication with a vacuum.

[0014] In one or more of the above aspects, the inner cuff is configured to inflate at a first pressure range and the outer bladder is configured to inflate at a second pressure range, wherein the first pressure range is lower than the second pressure range. For example, the inner cuff is configured to inflate to a pressure in a range of 10 cm H20 to 20 cm H20 and the outer bladder is configured to inflate to a pressure in a range of 50 cm H20 to 150 cm H20.

[0015] In one or more of the above aspects, the outer surface of the outer bladder is configured to have a relatively smooth surface during inflation.

[0016] In one or more of the above aspects, a first inflation lumen is coupled to an interior of the inner cuff; a second inflation lumen is coupled to an interior of the outer bladder.

[0017] In one or more of the above aspects, the inner cuff includes a relatively elastic material, wherein the relatively elastic material includes one or more of the following materials: silicone, latex, polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0018] In one or more of the above aspects, the outer bladder comprises a relatively inelastic material, wherein the relatively inelastic material comprises one or more of the following materials: polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0019] In one or more of the above aspects, the pressure regulator is configured to adjust a first pressure in the inner cuff using a first pneumatic path and to adjust a second pressure in the outer bladder using a different second pneumatic path, wherein the first pressure in the inner cuff is less than the second pressure in the outer bladder.

[0020] In one or more of the above aspects, a pressure sensor device is positioned between the inner cuff and the outer bladder, wherein the pressure sensor device measures an inter-cuff pressure.

[0021] In one or more of the above aspects, the pressure regulator is configured to adjust at least the first pressure in the inner cuff and the second pressure in the outer bladder in response to the inter-cuff pressure.

[0022] In one or more of the above aspects, a first lumen extends from the airway tube to the inner cuff, wherein the first lumen is fluidly coupled to the inner cuff; and a second lumen extends from the airway tube to the outer bladder, wherein the second lumen is fluidly coupled to the outer bladder.

[0023] In one or more of the above aspects, a pressure regulator system is configured to use the first lumen to maintain a first pressure in the inner cuff using addition or removal of air from the inner cuff and is configured to use the second lumen to maintain a second pressure in the outer bladder using addition or removal of air from the outer bladder, wherein the first pressure is less than the second pressure.

[0024] In one or more of the above aspects, a first air pump and a first release valve are fluidly coupled to the first lumen and are configured to add or remove air from the inner cuff; and a second air pump and a second release valve are fluidly coupled to the second lumen and are configured to add or remove air from the outer bladder.

[0025] In one or more of the above aspects, the pressure sensor device is positioned between the inner cuff and the outer bladder, wherein the pressure sensor device measures an inter-cuff pressure; and wherein the pressure adjuster system is configured to adjust the first pressure in the inner cuff and the second pressure in the outer bladder in response to the inter-cuff pressure.

[0026] In one or more of the above aspects, the secretion removal container includes an outer wall of the cuff assembly extending proximally from a proximal surface of the cuff assembly forming a trough for collecting secretions, wherein the trough is positioned at least on a posterior side of the airway tube, and a proximal sloped surface sloped inwardly from the outer wall toward a top surface of the cuff assembly forming a trough for collecting secretions.

[0027] In one or more of the above aspects, the secretion removal container includes an outer wall extending from a proximal end of the outer bladder to form a trough with a proximal surface of the inner cuff and / or a proximal surface of the outer bladder.

[0028] In one or more of the above aspects, the suction channel includes a catheter. A catheter guide is configured to hold the catheter, wherein the catheter guide is positioned on an anterior side of an outer surface at a proximal end of the airway tube. The catheter guide is rotated circumferentially to a position on a posterior side of an outer surface at a distal end of the airway tube.

[0029] In one or more of the above aspects, the suction channel is positioned inside the airway tube and extends on a posterior portion of an inner wall of the airway tube. The airway tube forms an opening proximate to the secretion removal container, wherein the hollow channel is in fluid communication with the secretion removal container through the opening to expel secretions. BRIEF DESCRIPTION OF DRAWINGS

[0030] Figure 1 An exemplary embodiment of a cuff system implemented with an airway tube is illustrated.

[0031] Figure 2 An exemplary embodiment of a cuff system is illustrated with a cross-section of an outer bladder.

[0032] Figures 3A-3D A cross-sectional view of an exemplary embodiment of a cuff system is illustrated.

[0033] Figure 4 A cross-sectional view of an exemplary embodiment of a cuff assembly implemented with an airway tube is illustrated.

[0034] Figures 5A-5B An exemplary embodiment of a tip end of an airway tube is illustrated in more detail.

[0035] Figure 6Exemplary embodiments of a cuff assembly are illustrated.

[0036] Figure 7 Exemplary embodiments of an airway cannula with a cuff assembly are illustrated.

[0037] Figure 8 Exemplary embodiments of a pressure regulator and control system for a cuff assembly are illustrated.

[0038] Figure 9 Exemplary embodiments of one or more methods for monitoring and controlling pressure of a cuff assembly are illustrated.

[0039] Figure 10A Exemplary embodiments of a secretion removal system are illustrated.

[0040] Figure 10B Exemplary embodiments of a proximal end of a catheter and a catheter guide are illustrated in more detail.

[0041] Figure 11A Another exemplary embodiment of a proximal end of an internal catheter guide is illustrated.

[0042] Figure 11B Another exemplary embodiment of a secretion removal container and suction catheter with an internal catheter guide is illustrated.

[0043] Figures 12A-12C Exemplary embodiments of various secretion collection containers implemented in conjunction with a cuff assembly are illustrated.

[0044] Figures 13A-13B Exemplary embodiments of various secretion collection containers implemented in conjunction with other types of airway cuffs are illustrated. DETAILED DESCRIPTION

[0045] The word “exemplary” or “implementation” is used herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “implementation” is not necessarily to be construed as preferred or advantageous over other implementations. Likewise, the term “aspect” does not require that all aspects of the disclosure include the discussed feature, advantage or mode of operation.

[0046] Implementations will now be described, by way of example, 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 one skilled in the art that the aspects described herein can be practiced without some or all of these specific details. In other instances, well known process steps have been omitted in order to not obscure the aspects of the disclosure. Similarly, well-known components have been omitted in the drawings and descriptions thereof in order to not obscure the aspects of the application.

[0047] SUMMARY

[0048] Described herein are cuff assemblies, pressure adjustment systems, and subglottal secretion removal systems that enable ventilation and protection of an intubated patient. The cuff assembly includes a toroidal outer bladder and an inner cuff. The inner cuff is positioned adjacent to an outer surface of an airway tube, and the outer bladder is positioned adjacent to an outer surface of the inner cuff. The outer bladder includes a less elastic material and behaves as a low volume high pressure (LVHP) structure such that when inflated, it exhibits less pleating for a more optimal tracheal seal. The inner cuff includes a more elastic or super-elastic material such that it behaves as a high volume low pressure (HVLP) structure.

[0049] The inner cuff and the outer bladder are each connected to a different one of two separate inflation tubes such that the pressure of each compartment is controlled separately. An intercuff pressure sensor is disposed between the inner cuff and the outer bladder that effectively measures tracheal wall pressure. A pressure adjustment system receives input from the intercuff pressure sensor and / or other pressure sensors. The pressure adjustment system automatically monitors and adjusts the air pressure of the inner cuff and the outer bladder at preset intervals in response to input from the pressure sensors.

[0050] The secretion removal system includes a secretion container and a suction catheter. In implementations, the secretion container is formed by a proximal end portion of the cuff assembly. For example, the outer bladder extends proximally further than a proximal end of the inner cuff (an outer bladder extension). The outer bladder extension is configured such that its peripheral wall extends further or has a greater length than its inner wall. In this way, a proximal end surface of the outer bladder extension is angled distally from the peripheral surface of the outer wall to the junction between the inner cuff and the outer bladder. The suction catheter evacuates accumulated secretions in the container. A guide or tube for the suction catheter extends from the secretion collection container to a proximal end of the airway tube. At the proximal end of the airway tube, the catheter guide is positioned on an anterior side of the airway tube such that it fits between the vocal cords of the intubated patient. The catheter guide extends circumferentially to be positioned on a posterior side of the airway tube at a distal end of the airway tube to access the catheter proximate the secretion container.

[0051] Alternatively, the suction conduit and suction conduit guide are replaced by a channel provided in the back wall of the endotracheal tube. The suction channel can be circular or elliptical and have a cross-sectional area between 10 and 20 square millimeters. A proximal channel opening is located at the proximal end of the endotracheal tube in fluid communication with the suction conduit which can then be connected to a vacuum. A distal opening of the suction channel is in fluid communication with the secretion collection lumen.

[0052] Embodiments of a cuff assembly

[0053] The cuff assembly will now be described in more detail. Unlike previously known endotracheal tube cuffs, the present embodiments described herein introduce a novel cuff system comprising at least two separately controlled inflatable bladders.

[0054] The high pressure outer bladder is attached to the outer surface of the endotracheal tube of the airway by means of an inner cuff. The inner cuff is coupled to the distal end of the endotracheal tube. A second, outer bladder is coupled to the outer surface of the inner cuff. The inner cuff is a low pressure inflatable cuff and is configured to operate in a low pressure range of 10 cm H20 to 20 cm H20. In contrast, the outer inflatable bladder is configured to inflate to a high pressure range of 50 cm H20 to 150 cm H20. Thus, the inner cuff operates in a pressure range that is lower than the pressure range of the outer bladder.

[0055] Figure 1 Embodiments of a cuff assembly 100 implemented with an endotracheal tube 102 are illustrated. The endotracheal tube 102 is a tube configured to pass through the mouth into the trachea to provide oxygenated air and / or other gases and medications to the lungs of a patient. The endotracheal tube 102 can comprise a soft polyvinyl chloride (PVC) material. Although an endotracheal tube 102 is described herein, the cuff assembly 100 can be implemented in conjunction with any suitable medical device including, but not limited to, a tracheostomy tube or other airway tube, a catheter, a stent, and / or a feeding tube.

[0056] Generally, the cuff assembly 100 is disposed proximally or otherwise towards the distal end of the endotracheal tube 102. The cuff assembly 100 includes a first annular or toroidal inner cuff 104 positioned around and proximate to the endotracheal tube 102. The inner cuff 104 is inflatable and configured to radially expand from the endotracheal tube 102. A second toroidal outer bladder 106 is positioned around and proximate to the inner cuff 104, with at least a portion of the inner cuff 104 located between the outer bladder 106 and the endotracheal tube 102. The outer bladder 106 is configured to radially expand from the inner cuff 104 such that an outer surface of the outer bladder 106 contacts the tracheal wall. In embodiments, as illustrated in FIG. 1, the outer bladder 106 is configured to radially expand from the inner cuff 104 such that an outer surface of the outer bladder 106 contacts the tracheal wall. In embodiments, as illustrated in FIG. 2, the outer bladder 106 is configured to radially expand from the inner cuff 104 such that an outer surface of the outer bladder 106 contacts the tracheal wall. Figure 1As shown, the top surface 114 of the outer cuff 106 can extend over the top surface of the inner cuff 104 and be sealed at the junction 116 with the inner cuff 104 and / or with the endotracheal tube 102. Straps 118 can secure and / or attach the cuff assembly 100 to the endotracheal tube 102.

[0057] The inner cuff 104 comprises a relatively elastic material, while the outer cuff 106 comprises a relatively inelastic material, e.g., the material of the outer cuff is less elastic than the material of the inner cuff 104. For example, the relatively elastic material of the inner cuff can comprise one or more of the following materials: silicone, latex, polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU). The relatively inelastic material of the outer cuff 106 can comprise one or more of the following materials: polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0058] The outer cuff 106 and the inner cuff 104 are configured to inflate and maintain different pressures. The relatively elastic inner cuff is configured to operate in an inflated state at a lower pressure, e.g., in a pressure range of 10 cm H2O to 20 cm H2O. In contrast, the less elastic or relatively inelastic outer cuff is configured to operate in an inflated state at a higher pressure range of 50 cm H2O to 150 cm H2O.

[0059] In use, e.g., when inserted into a trachea and subsequently pressurized to an inflated state, the first inner cuff 104 behaves as an HVLP cuff, while the second outer cuff 106 behaves as an LVHP cuff. The more compliant inner cuff 104 is able to adjust the pressure exerted on the tracheal wall by the higher pressurized outer cuff 106 ("tracheal pressure"). In other words, the lower pressure, more elastic inner cuff 104 is configured to absorb excessive pressure that can otherwise be exerted on the tracheal wall by the outer cuff 106. For example, due to the more compliant and elastic nature of the inner cuff 104, the cuff assembly 100 exerts a lower total pressure / force on the tracheal wall, e.g., lower than the outer cuff pressure. The force of the inner cuff 104 acts radially on the outer cuff 106, and thus is the force that is ultimately exerted on the trachea as the tracheal pressure. Thus, the radial force generated by the inner cuff 104 and acting on the outer cuff 106 is the tracheal pressure. For example, when the inner cuff pressure is greater than the outer cuff pressure, and the outer cuff is inflated such that the outer surface contacts the trachea, the inner cuff pressure is the same as the tracheal pressure.

[0060] Further, the outer cuff 106 in an inflated state forms a relatively smooth surface with fewer folds or wrinkles, e.g., fewer than an LVHP cuff. This reduction in wrinkles reduces the risk of leaks and results in a more uniform tracheal seal.

[0061] As such, the cuff assembly 100 utilizes an innovative system to titrate tracheal pressure, thereby reducing tracheal complications. By combining the characteristics of the HVLP cuff and the LVHP cuff into one system, the cuff system 100 takes advantage of the benefits found in both types of cuffs: superior tracheal seal, higher safety to the trachea. The cuff system 100 is characterized by a superior seal to the tracheal wall with reduced tracheal injury. Thus, the cuff assembly 100 helps to protect the lungs from contamination by oral gastric contents or blood without causing undue damage to the tracheal wall.

[0062] In embodiments, the cuff assembly 100 can further include a secretion collection system implemented to collect and remove suction or other fluids that can accumulate around the proximal end of the cuff assembly 100. The secretion collection system includes a secretion collection container 108 located on the proximal end of the cuff system 100. A suction catheter 110 is configured to empty the container 108 and is positioned in or adjacent to the container 108 on the posterior side of the endotracheal tube 102. A catheter guide 112 can encase the catheter 110 on the outer surface of the tube 102.

[0063] Figure 2 The cuff system 100 is illustrated with the outer bladder 106. In this embodiment, the outer bladder 106 is a separate structure, e.g., having a wall that is separate from the inner cuff 104 and the endotracheal tube 102. The outer bladder 106 includes an inner surface 210 and an outer surface 204. The inner surface 210 of the bladder 106 is positioned adjacent to the outer surface 214 of the inner cuff 104 and can be attached to the outer surface 214 of the cuff 104 using, e.g., one or more adhesives, heat, or by other means.

[0064] The outer bladder 106 is configured to be inflated and deflated by a first lumen 218 that communicates with the outer bladder 106 through an opening 222 formed in the lumen 218. The lumen 218 can be positioned in or connected to the interior or exterior of the endotracheal tube 102 and extends to the proximal end of the endotracheal tube 102.

[0065] The inner cuff 104 has a proximal band 212a and a distal band 212b that extend from the outer surface 214 of the cuff wall. These bands 212a, 212b are sized to accommodate the endotracheal tube 102. The proximal band 212a is positioned further away from the distal end of the endotracheal tube 102, while the distal band 212b is positioned closer to the distal end of the endotracheal tube 102. The bands 212a, 212b help to couple the inner cuff 104 to the endotracheal tube 102 and can also be attached to the endotracheal tube 102 using adhesives, heat, or by other means.

[0066] The inner cuff 104 is configured to be inflated and deflated via the second lumen 220, which communicates with the inner cuff 104 through a hole (not shown), such as an opening or notch, in the lumen 220. The second lumen 220 can be positioned on or attached to the interior or exterior of the endotracheal tube 102 and extend to the proximal end of the endotracheal tube 102.

[0067] The tip 224 of the endotracheal tube 102 forms a window 226 and / or opening 228 for passage of oxygenated air to the trachea. While described with an endotracheal tube 102, the cuff assembly 100 provided herein can be used in conjunction with any suitable medical device, including but not limited to other types of airway tubes, catheters, stents, and / or feeding tubes.

[0068] Figures 3A-3B A cross-sectional view of an embodiment of the cuff system 100 is illustrated. Figure 3A A top view cross-sectional view of the cuff system 100 is illustrated, Figure 3B A side view cross-sectional view of the cuff system 100 is illustrated. As Figure 3A shown, the outer cuff 106 is an inflatable torus or ring-shaped independent structure having an outer surface 204 and an inner surface 210. Similarly, the inner cuff 104 is an inflatable torus or ring-shaped independent structure having an outer surface 214 and an inner surface 302.

[0069] The inner surface 210 of the outer cuff 106 is proximate to and / or attached to the outer surface 214 of the inner cuff 104. The inner surface 302 of the inner cuff 104 is proximate to and / or attached to the outer surface 304 of the endotracheal tube 102. In this way, at least a portion of the inner cuff 104 is positioned between the outer cuff 106 and the endotracheal tube 102.

[0070] In embodiments, as Figure 1 shown, the proximal surface 306 of the outer cuff 106 extends to the inner cuff 104 and is sealed at the junction with the top surface 318 of the inner cuff 104 and / or with the endotracheal tube 102. Thus, the proximal surface 306 of the cuff 106 prevents leakage between the inner cuff 104 and the outer cuff 106. Alternatively or additionally, the outer surface 214 of the inner cuff 104 can be attached to form a seal that prevents leakage or pressed against the inner surface 210 of the outer cuff 106, for example, such that secretions or other substances cannot leak through the junction. For example, the inner cuff 104 and the outer cuff 106 can be adhesively attached or attached using a heat process or a combination thereof.

[0071] Further, the inner surface 302 of the inner cuff 104 is sealed or attached or pressed against the outer surface 304 of the endotracheal tube 102 to prevent leakage. For example, the inner cuff 104 and the endotracheal tube 102 can be adhesively connected or attached using a heat process or a combination thereof. These seals or attachments prevent leakage of secretions between the endotracheal tube 102 and the inner cuff 104.

[0072] In Figure 2 and the Figure 3B In another embodiment shown, the secretion collection reservoir 108 can be formed by using the outer surface 204 of the outer cuff 106 to form a wall 316. For example, a portion of the outer surface 204 of the outer cuff 106, such as on the proximal side of the cuff assembly 100, extends upward from the proximal surface 318 of the inner cuff 104. The proximal surface 306 of the outer cuff 106 can be angled inward from the wall 316 toward the proximal top surface 318 of the inner cuff 104 to form a valley or trough around at least a portion of the circumference of the endotracheal tube 102, such as at least on the posterior side of the endotracheal tube 102. This valley or trough of the secretion collection reservoir 108 collects secretions or particulates, which can be removed using the suction conduit 110, as further described herein. In Figure 2 and Figure 11B In another embodiment shown, the wall 316 of the outer cuff 106 is not angled. The outer surface 204 of the outer cuff forms a flat or relatively flat wall 316 that extends proximally and at a relatively perpendicular angle relative to the top surface 318 of the inner cuff 104.

[0073] Figure 3C and Figure 3D Another embodiment of the cuff system 100 is illustrated, in which the inner cuff 104 is formed at least partially using the outer surface 304 of the endotracheal tube 102. In this example, the inner surface 302 of the inner cuff 104 is formed by the outer surface 304 of the endotracheal tube 102. The outer surface 214 of the inner cuff 104 is attached to the outer surface 304 of the endotracheal tube 102 in a gas-tight seal. For example, the outer surface 214 of the inner cuff can form bands 212a, 212b that wrap around the endotracheal tube 102 to form a gas-tight seal to the endotracheal tube 102.

[0074] Figures 3A-3D One or more features of the various embodiments in

[0075] Figure 4A cross-sectional view of the cuff assembly 100 implemented with the endotracheal tube 102 is illustrated. In embodiments, the inner cuff inflation tube 220 and the outer bladder inflation tube 218 extend from the cuff assembly 100 at the distal end 404 of the endotracheal tube 102 to the proximal end 402 of the endotracheal tube 102. The inner cuff inflation tube 220 and the outer bladder inflation tube 218 are located in or on the interior or exterior of the endotracheal tube 102, for example, attached to the inner wall 410 of the endotracheal tube 102. In another embodiment, the inner cuff inflation tube 220 and the outer bladder inflation tube 218 are located on the outer surface 304 of the endotracheal tube 102.

[0076] In embodiments, the conduit guide 112 is positioned on the posterior side 408 of the endotracheal tube 102 proximate the secretion collection container 108. The conduit guide 112 then extends circumferentially around the endotracheal tube 102 to be disposed on the anterior side 406 of the endotracheal tube 102 at the proximal end of the conduit 102. The suction tube 110 is located within the conduit guide 112 and can be replaced in the event of a blockage or other malfunction.

[0077] In embodiments, the inner cuff 104 and the outer bladder 106 have approximately equal lengths L CA . For example, the length of the cuff assembly L CA is about 30 millimeters (mm). In other embodiments, one or more of the inner cuff 104 or the outer bladder 106 is longer or shorter than the other.

[0078] Further, in embodiments, the width W OB of the outer bladder and the width W IC of the inner cuff are approximately equal. For example, the width W OB of the outer bladder and the width W IC of the inner cuff is about 6 mm. In other embodiments, the width W OB of the outer bladder or the width W IC of the inner cuff can be different, for example, the inner cuff 104 can be wider or narrower than the outer bladder 106. The inner cuff 104 and the outer bladder 106 can have a thickness of about 0.00086 inches (0.022 mm) or less.

[0079] In another example, the inner diameter of the endotracheal tube 102 is about 8.5 mm and the outer diameter of the endotracheal tube is about 11.5 mm. The length of the endotracheal tube 102 is about 400 mm. These dimensions are exemplary and the cuff assembly 100 can be implemented with other endotracheal tubes having alternative dimensions or with other medical devices having various dimensions and sizes. Further, the exemplary dimensions and sizes of the cuff assembly 100 described herein can be modified according to the medical device and implementation.

[0080] Figure 5A and Figure 5BAn exemplary embodiment of the tip 224 of the endotracheal tube 102 is illustrated in greater detail. The tip 224 is at the distal end 404 of the endotracheal tube 102 on the distal end of the cuff assembly 100. The tip 224 can form an opening 228 with sloped walls, for example, which can form an angle of approximately 45 degrees. Additionally or alternatively, a window 226 is formed on one side of the tip 224. Thus, the tip 224 can include two openings 226, 228 for passing oxygenated air to the trachea.

[0081] The cuff assembly 100 provides an improved seal to the tracheal wall because the higher pressure outer cuff 106 forms a relatively smooth surface with fewer folds or wrinkles compared to, for example, an HVLP cuff. Additionally, the lower pressure inner cuff 104 creates a low total pressure on the tracheal wall by the cuff assembly 100, for example, similar to or less than the pressure of a typical HVLP cuff, but with an improved seal to the tracheal wall. Thus, the tracheal mucosa is subjected to a low total pressure and the risk of ischemic injury is lower. The cuff assembly 100 also has a smaller volume than an HVLP cuff, making it easier to intubate a patient.

[0082] Embodiments of a pressure adjustment system

[0083] The benefits and risks of an endotracheal tube compared to the tube itself depend on maintaining a predetermined pressure range in the cuff assembly. For example, over-inflation of the cuff assembly can result in tracheal mucosal injury, leading to ischemic injury and vocal cord nerve injury. This injury is due to the constant pressure exerted by the cuff that prevents blood flow to the tracheal mucosa. This loss of blood can result in tissue necrosis. Additionally, damage can also occur due to the repeated abrasion of the cuff as it moves over the tracheal wall. When the cuff is under-inflated and the tracheal seal is insufficient, the patient can not receive enough oxygen. Additionally, the patient has an increased likelihood of developing pneumonia due to aspiration of oral gastric contents. Thus, maintaining the pressure of the cuff assembly 100 of the endotracheal tube 102 is a critical part of patient care, reducing tracheal injury, and preventing ventilator-associated pneumonia (VAP).

[0084] Currently, several types of automatic cuff pressure adjusters are available. These current devices monitor the intra-cuff pressure within a single cuff. However, a closer examination reveals major deficiencies in this approach. The intra-cuff pressure does not reflect the exact pressure exerted on the tracheal wall. Ultimately, it is the tracheal wall pressure that determines the risks and benefits of the cuff. Thus, there is a need for an improved system and method to monitor and adjust the cuff pressure.

[0085] Figure 6An embodiment of an intersleeve pressure sensor device 602 in the sleeve assembly 100 is illustrated. In this embodiment, the pressure adjustment system monitors tracheal pressure by at least utilizing the intersleeve pressure sensor device 602 located between the inner sleeve 104 and the outer cuff 106. The pressure sensor device 602 can be fixedly attached to the outer surface 214 of the inner sleeve 104 or can be fixedly attached to the inner surface 210 of the outer cuff 106.

[0086] The force of the inner sleeve 104 acts radially on the outer cuff 106 and is thus the force that the tracheal pressure ultimately exerts on the tracheal wall. Thus, the radial force generated by the inner sleeve 104 and acting on the outer cuff 106 is the tracheal pressure generated. For example, when the intrasleeve pressure of the outer cuff is greater than the intrasleeve pressure of the inner sleeve 104 and the outer cuff 106 is inflated such that the outer surface 204 contacts the tracheal wall, the radial force of the inner sleeve 104 acting on the outer cuff 106 is the ultimate pressure acting on the tracheal wall. Because the intersleeve pressure sensor device 602 is positioned between the inner sleeve 104 and the outer cuff 106, it measures the radial force of the inner sleeve 104 acting on the outer cuff 106. As such, the pressure sensor 602 measures the tracheal pressure, e.g., the pressure exerted on the tracheal wall by the sleeve assembly 102.

[0087] In an embodiment, the intersleeve pressure sensor device 602 is electronically and communicatively attached to a lead 604 that extends from the pressure sensor 602 to a lead guide 606. The lead guide 606 protects the lead 604 and the trachea. The intrasleeve pressure sensor device 602 transmits the pressure measurements to the pressure adjustment system through the lead 604. In another embodiment, the pressure sensor device 602 includes a wireless transmitter, such as a radio frequency identification (RFID) transmitter or an Internet of Things (IoT) cellular transmitter. The pressure sensor device 602 can then wirelessly transmit the pressure measurements to the pressure adjustment system using the wireless transmitter.

[0088] Additional pressure sensor devices can be positioned within the sleeve assembly. For example, a pressure sensor device can be positioned in the inner sleeve 104 to measure the intrasleeve pressure within the inner sleeve 104. Further, a pressure sensor device can be positioned within the outer cuff 106 to measure its pressure. An additional pressure sensor device can be positioned on the outer surface of the cuff 106 to measure the tracheal pressure. An additional pressure sensor device can be positioned within the endotracheal tube 102 or at the tip 224 of the endotracheal tube 102 to measure the pressure of the oxygenated air delivered to the patient.

[0089] Figure 7An exemplary embodiment of an endotracheal tube 102 with a cuff assembly 100 is illustrated. A lead guide 606 and lead 604 therein extend from the cuff assembly 100 along the interior or exterior of the endotracheal tube 102 to the proximal end of the endotracheal tube 102. The lead 604 is then connected to a pressure regulation system for communication of cuff-to-cuff pressure measurements and / or power supply.

[0090] A first observation balloon 704 is attached at a distal end to a first lumen 218, which is fluidly coupled to the outer cuff 106. The first observation balloon 704 inflates with the outer cuff 106 and can be used as an indication of the pressure in the outer cuff 106 and whether the outer cuff 106 is inflated.

[0091] Similarly, a second observation balloon 706 is attached at a lower end to a second lumen 220, which is fluidly coupled to the inner cuff. The second observation balloon 706 inflates with the inner cuff 104 and can be used as an indication of the pressure in the inner cuff 104 and whether the inner cuff 104 is inflated.

[0092] The proximal ends of the first and second observation balloons 704, 706 include first and second adapters 708, 710. The first and second adapters 708, 710 are coupled to an air pump in a pneumatic device, as described below.

[0093] Figure 8 A schematic block diagram of an exemplary embodiment of a pressure regulator and control system ("regulator system") 800 for the cuff assembly 100 is illustrated. The regulator system 800 is in fluid communication with and inflates and regulates the pressure within the cuff assembly 100, for example, when the endotracheal tube 102 is implanted in the trachea of a patient. The pressure of the inner cuff 104 and outer cuff 106 of the cuff assembly 100 are monitored and controlled separately.

[0094] The regulator system 800 includes a pressure controller 806 and a pneumatic system 820. The pressure controller 806 includes a processor device 808 and a memory device 810. The memory device 810 includes one or more non-transitory processor-readable memories that store instructions that, when executed by the processor device 808 or other components of the regulator system 800, cause the regulator system 800 to implement one or more functions described herein. The processor device 808 includes at least one processing circuit, such as a microprocessor, microcontroller, digital signal processor, microcomputer, central processing unit, field programmable gate array, programmable logic device, state machine, logic circuit, analog circuit, digital circuit, and / or any device that manipulates signals (analog and / or digital) based on hard coding of the circuit and / or operational instructions. The memory device 810 includes a non-transitory memory device, and can be internal or external memory, and can be a single memory device or multiple memory devices. The memory device 810 can be read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, and / or any non-transitory memory device that stores digital information.

[0095] The pressure controller 806 can be co-located in the same physical device as the pneumatic system 820, or in separate devices or housings. The pressure controller 806 also includes a user interface 812. The user interface 812 generates user input and output (I / O), and includes one or more of a display, keyboard, touchscreen, mouse, touchpad, meter, switch, or other I / O device.

[0096] In use, the pressure controller 806 determines a desired predetermined pressure setting for the cuff assembly 100 in response to user input received by the user interface 812. Alternatively, a default pressure setting can be implemented, for example, in the absence of user input.

[0097] Different pressure settings can be set for the inner cuff 104 and the outer bladder 106. The pressure settings can be a predetermined pressure or a pressure range, for example, typically plus or minus 2 cm H2O. For example, the pressure setting for the inner cuff can be a pressure in the range of 10 cm H2O to 20 cm H2O (plus or minus 2 cm H2O). Conversely, the pressure setting for the outer inflatable bladder can be a pressure in the range of 50 cm H2O to 150 cm H2O (plus or minus 2 cm H2O). Thus, the inner cuff 104 operates in a pressure range that is lower than the operating pressure range of the outer bladder 106. The pressure controller 806 also determines the frequency at which the pressure of the cuff assembly 100 is measured and adjusted, for example, by user input or a default setting.

[0098] The pneumatic system 820 includes a first pneumatic path for the outer bladder 106 that includes, for example, a first air pump 822a and a release valve 824a that is fluidically coupled to the outer bladder 106 through, for example, an output port 826a, the adapter 708, the observation balloon 704, and the lumen 218. The pneumatic system 820 also includes a different second pneumatic path for the inner sleeve 104 that includes a second air pump 822b and a release valve 824b that is fluidically coupled to the inner sleeve 104 through, for example, an output port 826b, the adapter 710, the observation balloon 706, and the lumen 220. While two air pumps 822a, 822b are described herein, a single air pump can supply pressurized air to the inner sleeve 104 and the outer bladder 106, for example, using a valve or switch between the two fluidic paths.

[0099] Accordingly, the pneumatic system 820 includes separate pneumatic paths to independently and separately fluidically increase or decrease pressure in the air sleeve 104 and the outer bladder 106. The pneumatic paths can include separate air pumps 822a, 822b or a single air pump along with a valve that switches between the pneumatic path for the outer bladder 106 and the pneumatic path for the inner sleeve 104.

[0100] In operation, the pressure controller 806 receives pressure measurements from one or more pressure sensor devices to adjust the pressure of the sleeve assembly 100. For example, an inter-sleeve pressure sensor device 602 is positioned between the inner sleeve 104 and the outer bladder 106 and measures the radial force of the inner sleeve 104 acting on the outer bladder 106. Another inner sleeve pressure sensor device 802 can be positioned within the inner sleeve 104 to measure the intra-sleeve pressure. An outer bladder pressure sensor device 804 can be positioned to measure the pressure within the outer bladder 106. A further outer sleeve assembly pressure sensor device 814 can be positioned on the outer surface of the outer bladder 106 to further measure the tracheal wall pressure. Additional pressure sensor devices can also be implemented. The pressure sensor devices generate and transmit pressure measurements to the pressure controller 806, for example, through wired leads and / or wireless transmitters.

[0101] The regulator system 800 includes a pressure feedback loop in which the pressure controller 806 controls the pneumatic system 820 to adjust the pressure of both the inner cuff 104 and the outer bladder 106 in response to the pressure measurements. The pressure of the inner cuff 104 and the outer bladder 106 are monitored and controlled separately. The pressure controller 806 sends signals to the pneumatic system 820 to add or release air to the outer bladder 106 and / or the inner cuff 104. For example, to adjust the pressure in the outer bladder 106, the pressure controller 806 can signal the air pump 822a to add air to the outer bladder 106 or the release valve 824a to release air from the outer bladder 106. In another example, to adjust the pressure in the inner cuff, the pressure controller 806 can signal the air pump 822b to add air to the inner cuff 104 or the release valve 824b to release air from the inner cuff 104.

[0102] The regulator system 800 monitors the pressure measurements and automatically adjusts the pressure, first adjusting the pressure of the outer bladder 106 and second adjusting the pressure of the inner cuff 104, to achieve a predetermined pressure setting, for example pre-selected by an operator or according to a default. The pressure controller 806 can continuously monitor and adjust the pressure of the cuff assembly 100 or can monitor and adjust the pressure at predetermined time intervals. The regulator system 800 can also include visual and / or audible alarms at the event of unsafe pressure measurements.

[0103] Figure 9 A flowchart illustrating an embodiment of one or more methods 900 for monitoring and controlling the pressure of the cuff assembly 100, for example by the regulator system 800, is shown. At step 902, one or more pressure measurements related to the tracheal wall pressure are obtained by the regulator system 800 from one or more pressure sensor devices. At step 904, using these pressure measurements, the regulator system 800 determines whether the tracheal pressure (e.g. the pressure exerted by the cuff assembly 100 on the tracheal wall) is within a predetermined pressure range. The pressure measurements can be from the inter-cuff pressure sensor device 602 between the inner cuff 104 and the outer bladder 106 and / or from one or more pressure sensors 814 located on the outer surface of the outer bladder 106. When the tracheal pressure exceeds the predetermined pressure range, at step 906, the system 800 reduces the pressure in at least the inner cuff 104. For example, the regulator system 800 can control the release valve 824b to release air from the inner cuff 104. Since tracheal mucosal blood flow can be compromised at applied pressures higher than 30 cm H2O (22 mmHg), the regulator system 800 can reduce the pressure of at least the inner cuff 104 when the measured tracheal pressure exceeds 30 cm H2O (22 mmHg).

[0104] When the tracheal pressure is below the predetermined pressure range, at step 906, the regulator system 800 increases the pressure in at least the inner sleeve 104. For example, the regulator system 800 can control the air pump 822b to pump air into the inner sleeve 104. In addition, the pressure of the outer bladder 106 can also be adjusted. These steps can be performed at preset time intervals or continuously.

[0105] At step 908, the regulator system 800 obtains one or more pressure measurements related to the outer bladder pressure from one or more pressure sensor devices. At step 910, using these pressure measurements, the regulator system 800 determines whether the pressure of the outer bladder 106 is within the predetermined pressure range. For example, the pressure measurements can be from the pressure sensor device 804 located within the outer bladder 106 or at the observation balloon 704 for the outer bladder 106. When the outer bladder pressure is less than or greater than the predetermined pressure range, at step 912, the regulator system 800 increases or decreases the pressure in the outer bladder 106. For example, the regulator system 800 can control the air pump 822a to pump air into the outer bladder 106 when its pressure is below the predetermined pressure range or control the release valve 824a to release air from the outer bladder 106 when its pressure is above the predetermined pressure range. The outer bladder 106 can have a predetermined pressure range of 50 cm H2O to 150 cm H2O.

[0106] At step 914, the regulator system 800 obtains one or more pressure measurements related to the inner sleeve pressure from one or more pressure sensor devices. At step 916, using these pressure measurements, the regulator system 800 determines whether the pressure of the inner sleeve 104 is within the predetermined pressure range. For example, the pressure measurements can be from the pressure sensor device 802 located within the inner sleeve 104 or at the observation balloon 706 for the inner sleeve 104. When the inner sleeve pressure is less than or greater than the predetermined pressure range, at step 918, the regulator system 800 can increase or decrease the pressure in the inner sleeve 104. For example, the regulator system 800 can control the air pump 822b to pump air into the inner sleeve 104 when the pressure of the inner sleeve 104 is below the predetermined pressure range or control the release valve 824b to release air from the inner sleeve 104 when the pressure of the inner sleeve 104 is above the predetermined pressure range. The inner sleeve is a low-pressure inflatable sleeve and can have a predetermined pressure range of 10 cm H2O to 20 cm H2O.

[0107] The pressure of the inner cuff 104 and outer cuff 106 of the cuff assembly 100 is thus separately controlled using separate pneumatic paths (e.g., separate air pumps 822 and / or release valves 824 and separate air lumens 218, 220). The pressure of the less elastic outer cuff 106 is maintained at a higher pressure than the pressure of the more elastic inner cuff. Thus, the pressure controller 802 can independently adjust the pressure of the inner cuff 104 or the outer cuff 106 to adjust the tracheal pressure.

[0108] The cuff intra-pressure sensor 602 between the inner cuff 104 and the outer cuff 106 provides tracheal pressure measurements. The pressure controller 802 can independently adjust the pressure of the inner cuff 104 and / or the outer cuff 106 to adjust the tracheal pressure, for example, when the tracheal pressure exceeds or falls below an unsafe threshold.

[0109] Thus, the cuff assembly 100 and the adjuster system 800 help reduce micro- aspiration and lung infection by maintaining a good seal with the tracheal wall, but without unduly damaging the tracheal wall. The system provides improved airway sealing with minimal damage to the airway.

[0110] Embodiments of a secretion removal system

[0111] Mechanically ventilated (MV) patients experience an environment of physiological changes: decreased ability to clear oral and nasal secretions, decreased tracheobronchial mucociliary clearance, increased accumulation of secretions in the lungs and bronchi, decreased cough reflex, and increased likelihood of gastric reflux. The combined effect of all these factors is to predispose the mechanically ventilated patient to ventilator-associated pneumonia (VAP), a lung infection that develops in the patient, usually after 48 hours of mechanical ventilation.

[0112] In MV patients, the accumulation of secretions above the endotracheal tube (ETT) cuff (including, but not limited to, the cuff assembly 100 described herein) is a normal physiological phenomenon. The sources of the secretions are the oral cavity, the nasal sinuses, and the stomach (“orogastric secretions”). It is known that under normal conditions, the oral cavity and the nasal sinuses produce up to 3 liters of secretions per day. Again, this does not include gastric reflux, which can be an important factor. While a healthy person is able to eliminate and / or control the secretions, a ventilated patient is not. Instead, in a ventilated patient, secretions accumulate in the trachea above the ETT cuff or leak through the ETT cuff and into the trachea and lungs.

[0113] The concern with the accumulation of secretions above the ETT cuff is that the secretions harbor microorganisms, including bacteria and fungi. Because the secretions are heavily contaminated, they should be kept away from the body’s sterile organs. The lungs are one of those sterile organs. Therefore, the treating physician must prevent the secretions from leaking into the patient’s lungs.

[0114] The ETT cuff can be a robust suction barrier mechanism. When inflated, the ETT cuff should be in circumferential contact with the tracheal wall, thereby forming a complete seal. Unfortunately, it is known that ETT cuffs do not provide an effective seal, primarily due to the oversized cuff described above which forms wrinkles or folds.

[0115] One strategy to combat VAP is to enhance the occlusive function of the ETT cuff, such as improving the sealing ability of the ETT cuff, thereby reducing the leakage of secretions into the lungs, as discussed herein with the cuff assembly 100. While this strategy is helpful, if secretions are allowed to accumulate above the ETT cuff, the absolute pressure of the secretions will likely eventually result in leakage of the secretions into the lungs. Therefore, in addition to effective tracheal occlusion, an effective method of removing secretions is needed.

[0116] Current systems for removing secretions include a suction tube that accesses the proximal end of the ETT cuff. However, the configuration of the suction tube opening is known to cause direct trauma and suction trauma to the tracheal mucosa. The suction tube opening is configured such that it is prone to occlusion by the cuff wall. Additionally, due to its small size, the suction tube is prone to occlusion. A larger suction tube can increase the bulk of the tracheal tube enough to make the intubation process more difficult. Additionally, when the suction tube is integrated into the ETT, and the suction tube is occluded, the entire ETT and ETT cuff must be replaced. Therefore, an improved secretion removal system is needed.

[0117] Figure 10A An embodiment of a secretion removal system 1000 is illustrated that provides an improved system and method of effectively removing secretions from an ETT cuff 1002. The secretion removal system 1000 includes a secretion collection container 108, a suction catheter 110, and a catheter guide 112. The secretion removal system 1000 is shown implemented in conjunction with an endotracheal tube 102, but can also be implemented in conjunction with other medical devices, such as other types of airway tubes or stents. The ETT cuff 1002 can include the cuff assembly 100 described herein, or can include other types of cuffs, such as an HVLP cuff or an LVHP cuff.

[0118] The secretion collection container 108 is positioned on the proximal end or proximal end of the ETT cuff 1002 on the posterior side of the endotracheal tube 102. When a patient is in a prone position, such as is typical for intubated patients, secretions will tend to accumulate on the posterior side of the trachea. Since the container 108 is positioned on the posterior side of the ETT 102 and ETT cuff 1002, it will be more likely to collect accumulated secretions. In other embodiments, the container 108 can encircle the ETT 102. In other embodiments, the container 108 only encircles a portion of the circumference, such as 180 degrees of the circumference, on the posterior side 408 of the endotracheal tube (ETT) 102.

[0119] The conduit 110 is preferably a thin-walled, non-collapsible, and flexible hollow channel or tube. The conduit 110 is configured to evacuate the container 108, and thus at least the top end 1004 of the conduit 110 is positioned in or proximate to the container 108. The conduit top end 1004 is located posterior to the endotracheal tube 102 and the ETT cuff 1002. Thus, the conduit top end 1004 is in a favorable position to aspirate and remove secretions that tend to accumulate on the posterior side of the trachea and on the container 108 in a prone and intubated patient.

[0120] The conduit guide 112 surrounds the suction conduit 110 to provide protection to the conduit 110. The pre-formed channel of the conduit guide 112 is externally positioned on the outer surface of the ETT 102. At the proximal end 402 of the ETT 102, the conduit guide 112 extends along the anterior side 406 of the outer surface of the ETT 102. At the distal end 404 of the ETT 102, the conduit guide 112 extends around half the circumference of the ETT 102 to the posterior side 408 of the distal end 404 of the ETT 102.

[0121] A prone intubated patient includes an opening between the vocal cords on the anterior side of the trachea. Since the conduit guide 112 is positioned on the anterior side of the ETT 102 at the proximal end 402, the conduit guide 112 can be placed within this opening for the vocal cords without applying undue pressure to the trachea. Due to this positioning between the vocal cords, the conduit guide 112 and the suction conduit 110 can have an increased diameter. The larger diameter in the conduit 110 can help prevent occlusion. In one example, the conduit 110 can have an inner diameter of approximately 5 mm or an inner diameter in the range of 2 mm to 10 mm.

[0122] At the distal end 404 of the ETT 102, the conduit guide 112 and the conduit 110 rotate around the ETT 102 half the circumference to the posterior side 408 of the ETT 102 to improve collection of secretions that tend to accumulate on the posterior side of the trachea and the ETT cuff 1002. The conduit guide 112 can extend into or proximate to the collection container 108. The conduit top end 1004 extends into or proximate to the collection container 108. In one example, the conduit 110 and the top end 1004 comprise a semi-rigid material, such as one or more of the following materials: polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU). The conduit 110 can be sized between 7 to 12 French, such as a circumference of 7.33 mm to 12.57 mm. In an embodiment, the top end 1004 of the conduit includes at least two openings, such as one on each side of the top end 1004 opposite sides to reduce the likelihood of occlusion of the conduit.

[0123] Figure 10B Embodiments of the proximal end of the suction conduit 110 and the conduit guide 112 are illustrated in further detail. In an embodiment, the conduit 110 includes a depth indicator 1100 that provides an indication of proper positioning of the conduit 110 in the conduit guide 1102. The depth indicator 1100 can include a marking as a guide. In another embodiment, the depth indicator 1100 is a raised ridge that prevents the conduit 110 from being inserted further into the conduit guide 112.

[0124] The proximal conduit end 1102 is configured to be connected to a vacuum source using a suction tube. The conduit 110 can be connected to the vacuum source intermittently or continuously. When connected, the vacuum source can be operated continuously or intermittently to clear the secretions from the container 108. The conduit end 1102 can also be adapted for use with a syringe or other flushing device. An alarm can be triggered when the conduit is occluded.

[0125] Figure 11A and Figure 11B An exemplary embodiment of a hollow suction channel 1122 formed within the endotracheal tube 102 is illustrated. In this embodiment, the internal suction channel 1122 is located within the interior of the endotracheal tube 102. For example, the suction channel 1122 can be formed by a section of the inner wall 1124 of the endotracheal tube 102 and a longitudinal partition 1120 extending through the section of the inner wall 1124. The section of the inner wall 1124 and the longitudinal partition 1120 are positioned on the posterior side 408 of the endotracheal tube 102 to form a hollow tube or lumen. The suction channel 1122 extends from the proximal end of the endotracheal tube 102 to a location within the endotracheal tube 102 that is beside or proximate to the secretions container 108.

[0126] In one embodiment, the suction channel 1122 is in fluid communication with the secretions container 108 through an opening 1126 formed through the wall of the endotracheal tube 102. The opening 1126 is positioned on the posterior side of the endotracheal tube 102 within or proximate to the container 108. Secretions are then expelled from the secretions container 108 through the opening 1126, through the suction channel 1122, and to the proximal end 1128 of the endotracheal tube 102. A suction conduit (not shown) can be fluidly coupled to the proximal end 1128 of the suction channel 1122 and coupled to a vacuum, without the conduit continuing through the lumen of the suction channel 1122.

[0127] In another embodiment, for example Figure 11BAs shown, the conduit 110 can be inserted into the suction channel 1122. In this embodiment, the suction channel 1122 is configured to mate with the suction conduit 110. For example, the suction conduit 110 can have an outer diameter of 4 mm. The suction channel 1122 can then have an opening that is greater than 4 mm, such as 4.1 to 4.5 mm, so that the suction conduit 110 can slide through the conduit guide with the suction conduit 110 removed and / or a new suction conduit 110 inserted. The opening 1126 has a diameter or dimension configured to accommodate the distal end of the suction conduit 110. The distal end of the suction conduit 110 extends outward from the opening 1126 into the container 108. The suction conduit 110 is in fluid communication with the container 108 to remove accumulated secretions. The conduit guide 1122 can include a sloped surface or bottom at the opening 1126 that spans the diameter of the conduit guide to guide and position the distal end of the conduit 110 through the opening 1126.

[0128] Figures 12A-12C Exemplary block diagrams of various embodiments of a secretion collection container 108 implemented in conjunction with a cuff assembly 100, such as including an inner cuff 104 and an outer bladder 106, are illustrated. In Figure 12A In one embodiment, the secretion collection container 108 is formed using the outer surface 204 of the outer bladder 106. For example, a portion of the outer surface 204 of the outer bladder 106, such as on the proximal surface 306 of the outer bladder 106, extends beyond the outer surface 214 of the inner cuff 104 to form an outer wall. The proximal end 306 of the outer bladder 106 can be angled inward toward the outer surface 214 of the inner cuff 104 to form a valley or trough around the endotracheal tube 102. The valley or trough forms the secretion collection container 108. The floor of the collection container 108 is defined by the proximal surface of the inner cuff 104, which can be reinforced with a material that is stiffer, less elastic, or not reinforced than other portions of the inner cuff 104.

[0129] The length of the outer wall 204 of the container 108 can be in the range of 2 mm to 15 mm. The container 108 can span 180 degrees on the posterior side of the cuff assembly 100. The container 108 helps to protect the tracheal wall from suction damage or direct injury from the suction conduit 110. The outer wall 204 forming the container 108 can include a sheet of PVC to oppose and seal against the tracheal wall and allow secretions to flow into the well. The stiff PVC sheet helps to prevent leakage of secretions. The floor of the container 108 can include a thin plastic sheet extending from the junction between the outer surface of the inner cuff and the inner surface of the outer bladder.

[0130] Figure 12BEmbodiments are illustrated in which the proximal surfaces 306, 310 of the outer cuff 106 and inner sleeve 104 are inwardly inclined toward the outer surface 304 of the endotracheal tube 102 to form a valley or trough around at least a portion of the endotracheal tube 102. The valley or trough forms the secretion collection reservoir 108.

[0131] In Figure 12C In some embodiments, a separate structure 1200 attached to the proximal end of the cuff assembly forms the secretion collection reservoir 108 on the posterior side 408 of the ETT 102. The separate structure 1200 can be attached to one or both of the inner sleeve 104 and the outer cuff 106. The separate structure 1200 can include an inclined top surface 1202 that is inwardly inclined toward the outer surface 304 of the ETT 102 to form a valley or trough.

[0132] Figures 13A-13B Schematic block diagrams of various embodiments of a secretion collection reservoir 108 implemented in conjunction with other types of ETT cuffs 1002 are illustrated. Other types of ETT cuffs 1002 can include, for example, HVLP or LVHP cuffs with a single balloon, or can include other types of medical cuffs, such as for use with a stent or other medical device.

[0133] In Figure 13A In some embodiments, the reservoir 108 is formed by at least a portion of the outer wall 1304 of the ETT cuff 1002, for example on the proximal end 1306 of the ETT cuff 1002. The outer wall 1304 extends beyond the inner wall 1302, and can be inclined toward the outer surface 304 of the ETT 102 to form a valley or trough around the ETT 102. The valley or trough forms the secretion collection reservoir 108.

[0134] In Figure 13B In some embodiments, a separate structure 1310 attached to the proximal end 1306 of the ETT cuff 1002, for example on the posterior side 408 of the ETT 102, forms the secretion collection reservoir 108. The separate structure 1310 can include an inclined top surface 1308 that is inwardly inclined toward the outer surface 304 of the ETT 102 to form a valley or trough.

[0135] In Figures 12A-1 2D and Figures 13A-13BIn these embodiments, the secretion collection container 108 can completely or only partially surround the ETT 102. The top end of the suction catheter 110 is positioned within or in close proximity to the trough of the secretion collection container 108. The collection container 108 helps to protect the tracheal wall from suction trauma or direct injury from the suction catheter 110. Additionally, the catheter guide 112 holds the top end of the suction catheter 110 in close proximity to the outer surface 304 of the ETT 102 and within or close to the collection container 108. This positioning of the top end of the catheter 110 also helps to protect the tracheal wall.

[0136] Accordingly, the secretion removal system 1000 helps to reduce the likelihood of damaging the tracheal mucosa. It also helps to reduce the occlusion of the opening in the top end 1004 of the catheter 110 by the cuff wall, for example, to prevent the cuff from being suctioned into the catheter 110. The retractable catheter 110 in the catheter guide 112 makes intubation of the ETT 102 less cumbersome. Additionally, a larger diameter catheter 110 can be employed due to the placement of the catheter guide, which reduces the chance of occlusion.

[0137] The cuff assembly 100, the adjuster system 800, and the secretion removal system 1000 improve the protection and safety of the intubated patient. The cuff system 100 and the adjuster system 800 maintain an improved seal with the tracheal wall, which reduces the leakage of secretions and infection of the lungs without unduly damaging the tracheal wall. The secretion removal system 1000 also helps to reduce the likelihood of damaging the tracheal mucosa by using the secretion container 108 and the catheter guide 112. It also helps to reduce the occlusion of the opening in the top end 1004 of the catheter 110 by the secretions or the material of the cuff. In one or more embodiments described in the specification and / or claims, additional or alternative advantages and improvements are possible.

[0138] As used herein, the term "operatively" or "configurably" means that an element includes one or more of circuitry, instructions, modules, data, inputs, outputs, etc. to perform one or more of the described or necessary respective functions, and can also include an inferred coupling with one or more other items to perform the described or necessary respective functions. As can also be used herein, the terms "coupled," "coupled to," "connected to," and / or "connected" or "interconnected" include direct connection or linkage between nodes / devices and / or indirect connection between nodes / devices via intermediate items. As can further be used herein, an inferred connection (i.e., where one element is connected to another by inference) includes both direct and indirect connections between two items in the same manner as "connected to." As used herein, the terms "substantially" and "approximately" provide an industry-acceptable tolerance for the relative between their respective terms and / or items.

[0139] Note that aspects of the present disclosure can be described herein in terms of processes that are depicted as schematic illustrations, flow charts, flow diagrams, block / functional diagrams, or block diagrams. Although the flow diagrams can describe operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations can be re-arranged. A process is terminated when its operations are completed. A process can correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination corresponds to a return of the function to the calling function or the main function.

[0140] The various features of the present disclosure described herein can be implemented in different systems and devices. It should be noted that the foregoing aspects of the present disclosure are merely examples and are not to be construed as limiting the present disclosure. The description of aspects of the present disclosure is intended to be illustrative, and not to limit the scope of the claims. As such, the present disclosure is applicable to other types of apparatuses and many alternatives, modifications, and variations will be apparent to those skilled in the art.

[0141] In the foregoing specification, certain representative aspects have been described. However, the application can be practiced without resorting to the details specifically set forth in the foregoing description. The specification and drawings are to be regarded in an illustrative rather than a restrictive sense. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present application as contemplated by the inventors. Accordingly, the scope of the application should be determined with reference to the claims and their legal equivalents rather than by reference to the description of the application or the illustrative examples. For example, in any apparatus claim asserting a component and / or element, the depicted arrangement is merely an example of the component and / or element and therefore is not meant to be limiting. The component and / or element can be assembled or otherwise operatively configured in various arrangements and therefore is not limited to the specific configuration depicted in the claim.

[0142] Moreover, certain benefits, other advantages, and solutions to problems have been described above with regard to particular embodiments; however, any benefit, advantage, solution to problems, or any element that causes any particular benefit, advantage, or solution to occur or become more pronounced are not to be construed as essential elements of any or all claims. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.

[0143] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," "contains," "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, composition, or apparatus that comprises, includes, has, contains, or contains one or more elements, does not include an exclusive list of those elements. Other combinations and / or modifications of the above-described structures, arrangements, applications, proportions, elements, materials or components used in the practice of the present application, in addition to those not specifically recited herein, can be varied or otherwise particularly adapted to specific environments, manufacturing specifications, design parameters, or other operating requirements without departing from the general scope of the present application.

[0144] Further, reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." Unless specifically stated otherwise, the term "some" refers to one or more. All structural and functional equivalents to the elements described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase "means for."

Claims

1. A medical device, the medical device comprising: Endotracheal cannula, wherein the endotracheal cannula is configured to fit within the trachea; as well as A sleeve assembly implemented at the lower end of the endotracheal tube, the sleeve assembly comprising: An inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the endotracheal tube, and wherein the inner cuff has a first elasticity; and An inflatable outer bladder is positioned adjacent to the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity less than the first elasticity of the inner sleeve, wherein the inner sleeve is configured to inflate within a first pressure range, and wherein the outer bladder is configured to inflate within a second pressure range, wherein the first pressure range is lower than the second pressure range.

2. The medical device according to claim 1, wherein, The inner sleeve is configured to be inflated to a first pressure within the first pressure range of 10 cm H2O to 20 cm H2O, and the outer bladder is configured to be inflated to a second pressure within the second pressure range of 50 cm H2O to 150 cm H2O.

3. The medical device according to claim 1, wherein, The outer surface of the outer capsule is configured to have a relatively smooth surface during inflation.

4. The medical device according to claim 1, further comprising: A first inflation tube connected to the interior of the inner sleeve; as well as A second inflation tube connected to the interior of the outer capsule.

5. The medical device according to claim 1, wherein, The inner sleeve comprises a relatively elastic material, wherein the relatively elastic material includes one or more of the following materials: silicone, latex, polyvinyl chloride (PVC), neoprene, polyisoprene, or polyurethane (PU).

6. The medical device according to claim 1, wherein, The outer capsule comprises a relatively inelastic material, wherein the relatively inelastic material comprises one or more of the following materials: polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene rubber, polyisoprene, or polyurethane (PU).

7. The medical device according to claim 1, further comprising: A secretion collection container, the secretion collection container being positioned at the proximal end of the sleeve assembly; as well as A suction channel, the suction channel including a distal end near the secretion collection container and a proximal end of the suction channel at the proximal end of the endotracheal tube, wherein the proximal end of the suction channel is in fluid communication with a vacuum.

8. The medical device according to claim 7, wherein, The secretion collection container includes: The outer wall of the sleeve assembly, extending proximal to proximal from the proximal surface of the sleeve assembly, forms a groove for collecting secretions, wherein the groove is positioned at least posterior to the endotracheal cannula; and A proximal inclined surface, which slopes inward from the outer wall toward the top surface of the sleeve assembly, forms the groove for collecting secretions.

9. The medical device according to claim 7, wherein, The secretion collection container includes an outer wall that extends from the proximal end of the outer sac to form a groove with the proximal surface of the inner sleeve and / or the proximal surface of the outer sac.

10. The medical device according to claim 7, wherein, The aspiration channel includes a catheter, and the medical device further includes: A catheter guide, configured to retain the catheter, wherein the catheter guide is positioned on the anterior side of the outer surface of the proximal end of the endotracheal tube; and The catheter guide is circumferentially rotated at the distal end of the endotracheal tube to a position on the rear side of the outer surface.

11. The medical device according to claim 7, wherein, The suction channel is located inside the endotracheal cannula and extends on the posterior portion of the inner wall of the endotracheal cannula; and The endotracheal tube forms an opening close to the secretion collection container, and the hollow channel is in fluid communication with the secretion collection container through the opening to discharge secretions.

12. A medical device, the medical device comprising: Endotracheal cannula, wherein the endotracheal cannula is configured to fit within the trachea; A sleeve assembly implemented at the lower end of the endotracheal tube, the sleeve assembly comprising: An inflatable inner sleeve having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the endotracheal tube, and wherein the inner sleeve has a first elasticity; An inflatable outer bladder positioned adjacent to the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity less than the first elasticity of the inner sleeve; and Pressure regulator, the pressure regulator being configured to: The first pressure in the inner sleeve is adjusted using a first pneumatic path; and The second pressure within the outer bladder is adjusted using different second pneumatic paths, wherein the first pressure in the inner sleeve is less than the second pressure in the outer bladder.

13. The medical device according to claim 12, further comprising: A pressure sensor device positioned between the inner sleeve and the outer pouch, wherein the pressure sensor device measures the pressure between the sleeves.

14. The medical device according to claim 13, wherein, The pressure regulator is configured to adjust at least the first pressure in the inner sleeve and the second pressure in the outer pleat in response to the cuff pressure.

15. An endotracheal cannula with a sleeve assembly, the endotracheal cannula with the sleeve assembly comprising: An inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the endotracheal tube, and wherein the inner cuff has a first elasticity; and A first lumen extends from the endotracheal tube to the inner sleeve, wherein the first lumen is fluidly connected to the inner sleeve; An inflatable outer bladder positioned adjacent to the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity less than the first elasticity of the inner sleeve; and A second lumen extends from the endotracheal tube to the external capsule, wherein the second lumen is fluidly connected to the external capsule, wherein the inner sleeve is configured to be inflated using the first lumen within a first pressure range, and wherein the external capsule is configured to be inflated using the second lumen within a second pressure range, wherein the first pressure range is lower than the second pressure range.

16. The endotracheal cannula with a sleeve assembly according to claim 15, wherein the endotracheal cannula with a sleeve assembly further comprises: A pressure regulator system configured to use the first lumen to add air or remove air from the inner cuff to maintain a first pressure within the first pressure range in the inner cuff, and configured to use the second lumen to add air or remove air from the outer bladder to maintain a second pressure within the second pressure range in the outer bladder.

17. The endotracheal cannula with a sleeve assembly according to claim 16, wherein, The pressure regulator system includes: A first air pump and a first release valve, the first air pump and the first release valve being fluidly connected to the first cavity and configured to add air or remove air from the inner sleeve; and A second air pump and a second release valve are fluidly connected to the second cavity and configured to add air or remove air from the outer bladder.

18. The endotracheal cannula with a sleeve assembly according to claim 16, wherein the endotracheal cannula with a sleeve assembly further comprises: A pressure sensor device is positioned between the inner sleeve and the outer puff, wherein the pressure sensor device measures the inter-sleeve pressure; and The pressure regulator system is configured to adjust the first pressure in the inner sleeve and the second pressure in the outer pleat in response to the cuff pressure.

19. A medical device, the medical device comprising: An endotracheal tube, the endotracheal tube being configured to be fitted into the trachea; A sleeve assembly, wherein the sleeve assembly is disposed at the lower end of the endotracheal tube, the sleeve assembly comprising: An inflatable inner sleeve having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the endotracheal tube, and wherein the inner sleeve has a first elasticity; A first inflation tube connected to the interior of the inner sleeve; and An inflatable outer bladder positioned adjacent to the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity less than the first elasticity of the inner sleeve; and A second inflation lumen is connected to the interior of the outer bladder, wherein the inner sleeve is configured to be inflated within a first pressure range using the first inflation lumen, and wherein the outer bladder is configured to be inflated within a second pressure range using the second inflation lumen, wherein the first pressure range is lower than the second pressure range.

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