Systems and methods for endotracheal cannula assemblies

Abstract

A sleeve assembly for an airway cannula includes an outer bladder and an inner sleeve. The inner sleeve is positioned adjacent the airway cannula, and the outer bladder is positioned adjacent the inner sleeve. The outer bag is made of materials with small elasticity and works under high relative pressure. The inner sleeve is made of a more elastic or superelastic material and operates at a lower relative pressure. A pressure controller independently adjusts the pressure within the inner sleeve and the outer bladder. A secretion collection container is formed from the sleeve assembly and emptied via a suction catheter or channel.

Description

[0001] Priority claim

[0002] This application claims priority to and the benefit of patent application No. 17 / 848,273 filed in the U.S. Patent Office on June 23, 2022, the entire contents of which are incorporated herein by reference as if fully set forth below 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 regulation systems for cuff assemblies, and secretion clearance systems. Background Art

[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 harder, relatively inelastic material. 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 excessive 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, e.g., an incidence of 5% to 20%. Nevertheless, a key advantage of the LVHP cuff when inflated is the relative absence of wrinkles or wrinkles, resulting in an excellent tracheal seal. The LVHP cuff was first used in the mid-1960s, but has now been widely replaced by the HVLP cuff.

[0005] The HVLP cuff is 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 tracheal diameter 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 path 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 capillary perfusion pressure of the human tracheal wall mucosa ranges from 22 to 32 mmHg and that tracheal mucosal blood flow may be compromised at applied pressures above 30 cm H2O (22 mmHg), with blood flow to some segments completely occluded at 50 cm H2O (37 mmHg). Therefore, it is clear that there is only a small overlap between the safe pressure range and the complication pressure range. In practice, the window of effectiveness and safety is very narrow or even nonexistent.

[0007] The pressure required to achieve reasonable inflation of a typical HVLP cuff with an acceptable number of folds or wrinkles is approximately 32 cmH2O. Guidelines developed by various medical societies and organizations recommend that HVLP cuff pressures be maintained in the range of 20 cmH2O to 30 cmH2O to avoid occlusion of tracheal mucosal blood flow. However, even with strict adherence to these recommendations, many patients are still at risk. In fact, one study showed that approximately 10% of patients receiving mechanical ventilation developed ventilator-associated pneumonia (VAP), and the mortality rate of VAP was estimated to be 13%. In addition, patients with VAP require longer hospital stays and have higher medical costs compared to similarly ill patients without VAP. Considering that approximately 750,000 patients in the United States require ventilators each year, the human and economic losses caused by VAP are enormous.

[0008] Unfortunately, studies have shown that microsucking of the HVLP cuff occurs even at pressures as high as 60 cm H2O, suggesting that even at higher pressures the cuff continues to have wrinkles that allow secretions to pass through. Therefore, even though HVLP cuffs appear superior due to their ability to create a seal at lower pressure levels and avoid tracheal wall necrosis, they are still far from ideal.

[0009] While the primary goal of a tracheal cuff to provide a maximum airway seal with minimal damage to the airway is straightforward, achieving this goal successfully remains difficult. Despite various modifications and improvements to materials, shapes, and volume structures, this goal has eluded achievement. Therefore, there is a need for an improved cuff system that helps reduce microaspiration and lung infection by maintaining a good seal with the tracheal wall while avoiding excessive damage to the tracheal wall. Summary of the invention

[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 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 adjacent to the airway cannula, and wherein the inner cuff has a first elasticity. An inflatable outer bladder is positioned adjacent 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 an endotracheal airway tube includes an inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the endotracheal airway tube, and wherein the inner cuff is configured to be inflated within a first pressure range. The cuff assembly also includes an inflatable outer bladder positioned proximate the outer surface of the inner cuff, wherein the outer bladder is configured to be inflated within 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 sleeve assembly implemented at a lower end of the airway tube. The sleeve assembly includes an inflatable inner sleeve having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the airway tube, and wherein the inner sleeve has a first elasticity. The sleeve assembly also includes an inflatable outer bladder positioned adjacent to the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity that is less than the first elasticity of the inner sleeve. The medical device also includes a pressure regulator configured to set a first pressure for the inner sleeve and a second pressure for the outer bladder, wherein the first pressure for the inner sleeve is less than the second pressure for the outer bladder.

[0013] In one or more of the above aspects, a secretion clearing system for an airway tube includes a secretion collection container at a proximal end of a sleeve assembly, wherein the sleeve assembly is disposed around a circumference of the airway tube. The system also includes a suction channel, the suction channel including a distal end proximal to the secretion collection container and a proximal end of the suction channel at the proximal end of the airway tube, wherein the proximal end of the suction channel is in communication with a vacuum fluid.

[0014] In one or more of the above aspects, the inner cuff is configured to be inflated within a first pressure range and the outer bladder is configured to be inflated within a second pressure range, wherein the first pressure range is lower than the second pressure range. For example, the inner cuff is configured to be inflated to a pressure within a range of 10 cm H2O to 20 cm H2O, and the outer bladder is configured to be inflated to a pressure within a range of 50 cm H2O to 150 cmH2O.

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

[0016] In one or more of the above aspects, the first inflation lumen is connected to the interior of the inner sleeve; and the second inflation lumen is connected to the interior of the outer balloon.

[0017] In one or more of the above aspects, the inner sleeve comprises a relatively elastic material, wherein the relatively elastic material comprises 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 bag 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 adjust a second pressure in the outer bag using a different second pneumatic path, wherein the first pressure in the inner cuff is less than the second pressure in the outer bag.

[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 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 connected to the inner cuff; and a second lumen extends from the airway tube to the outer balloon, wherein the second lumen is fluidly connected to the outer balloon.

[0023] In one or more of the above aspects, the pressure regulator system is configured to use the first lumen to add air or remove air from the inner cuff to maintain a first pressure within the inner cuff, and is configured to use the second lumen to add air or remove air from the outer balloon to maintain a second pressure within the outer balloon, 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 connected to the first lumen and are configured to add air or remove air from the inner cuff; and a second air pump and a second release valve are fluidly connected to the second lumen and are configured to add air or remove air from the outer balloon.

[0025] 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 inter-cuff pressure; and wherein the pressure regulator 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 clearing container comprises an outer wall of a sleeve assembly and a proximal inclined surface, wherein the outer wall extends proximally from the proximal surface of the sleeve assembly to form a groove for collecting secretions, wherein the groove is positioned at least on the rear side of the airway tube, and the proximal inclined surface is inclined inwardly from the outer wall toward the top surface of the sleeve assembly to form a groove for collecting secretions.

[0027] In one or more of the above aspects, the secretion collecting container includes an outer wall extending from the proximal end of the outer balloon to form a groove with the proximal surface of the inner sleeve and / or the proximal surface of the outer balloon.

[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 a front side of an outer surface at a proximal end of an airway tube. The catheter guide is circumferentially rotated to a position on a rear 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 rear portion of an inner wall of the airway tube. The airway tube forms an opening close to a secretion collection container, wherein the hollow channel is in fluid communication with the secretion collection container through the opening to discharge secretions. BRIEF DESCRIPTION OF THE 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 sleeve system is illustrated using a cross-section of an outer bladder.

[0032] FIG. 3A to FIG. 3D A cross-sectional view of an exemplary embodiment of a sleeve 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] FIG. 5A to FIG. 5B Exemplary embodiments of the tip of an airway tube are illustrated in more detail.

[0035] Figure 6An exemplary embodiment of a cuff pressure sensor device in a cuff assembly is illustrated.

[0036] Figure 7 An exemplary embodiment of an airway tube with a cuff assembly is illustrated.

[0037] Figure 8 A schematic block diagram of an exemplary embodiment of a pressure regulator and control system for a cuff assembly is illustrated.

[0038] Fig. 9 A flow chart illustrating an embodiment of one or more methods for monitoring and controlling pressure of a cuff assembly.

[0039] Fig. 10A Exemplary embodiments of secretion clearance systems are illustrated.

[0040] Fig. 10B Exemplary embodiments of the proximal end of the catheter and the catheter guide are illustrated in greater detail.

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

[0042] Fig. 11B Another exemplary embodiment of a secretion clearance container and an aspiration catheter having an inner catheter guide is illustrated.

[0043] FIG. 12A to FIG. 12C Schematic block diagrams of various exemplary embodiments of a secretion collection container implemented in conjunction with a cuff assembly are illustrated.

[0044] FIG. 13A to FIG. 13B Schematic block diagrams illustrating various exemplary embodiments of secretion collection containers implemented in conjunction with other types of airway cuffs. DETAILED DESCRIPTION

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

[0046] Embodiments will now be described in detail with reference to the accompanying drawings. In the following description, many specific details are set forth in order to provide a thorough understanding of the aspects described herein. However, those skilled in the art will appreciate that these and other aspects may be practiced without some or all of these specific details. In addition, in order not to obscure the various aspects of the present disclosure, well-known steps in the methods of the process may be omitted from the flowcharts presented herein. Similarly, well-known components in the device may be omitted from the drawings and descriptions thereof presented herein to avoid confusing the various aspects of the present invention.

[0047] Overview

[0048] The present invention describes a sleeve assembly, a pressure adjustment system, and a subglottic secretion removal system that achieve ventilation and protection of an intubated patient. The sleeve assembly includes a donut-shaped outer bladder and an inner sleeve. The inner sleeve is positioned adjacent to the outer surface of the airway cannula, and the outer bladder is positioned adjacent to the outer surface of the inner sleeve. The outer bladder includes a less elastic material and exhibits a low volume high pressure (LVHP) structure so that when inflated, it exhibits fewer wrinkles for a more optimized tracheal seal. The inner sleeve includes a more elastic or superelastic material so that it exhibits a high volume low pressure (HVLP) structure.

[0049] The inner cuff and outer bladder are each connected to a different one of two separate inflation tubes so that the pressure of each compartment is individually controlled. An intercuff pressure sensor is disposed between the inner cuff and the outer bladder, which effectively measures the tracheal wall pressure. The 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 outer bladder at preset intervals in response to the input from the pressure sensor.

[0050] The secretion removal system includes a secretion container and a suction catheter. In an embodiment, the secretion container is formed by the proximal portion of the sleeve assembly. For example, the outer bladder extends proximally farther than the proximal end of the inner sleeve (outer bladder extension). The outer bladder extension is configured so that its peripheral wall extends farther or has a greater length than its inner wall. In this way, the proximal surface of the outer bladder extension is inclined distally from the outer peripheral surface of the outer wall to the junction between the inner sleeve and the outer bladder. The suction catheter discharges the secretions accumulated in the container. A guide or tube for the suction catheter extends from the secretion collection container to the proximal end of the airway cannula. At the proximal end of the airway cannula, the catheter guide is positioned on the front side of the airway cannula so that it fits between the vocal cords of the intubated patient. The catheter guide extends circumferentially to be located on the rear side of the airway cannula at the distal end of the airway cannula, thereby positioning the catheter close to the secretion container.

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

[0052] Embodiments of the sleeve assembly

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

[0054] The high pressure outer balloon is attached to the outer surface of the airway endotracheal tube by means of an inner cuff. The inner cuff is coupled to the distal end of the endotracheal tube. Second, the outer balloon 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 H2O to 20 cm H2O. In contrast, the outer balloon is configured to expand to a high pressure range of 50 cm H2O to 150 cm H2O. Thus, the inner cuff operates in a pressure range lower than the pressure range of the outer balloon.

[0055] Figure 1 An embodiment of the sleeve assembly 100 implemented with an endotracheal tube 102 is illustrated. The endotracheal tube 102 is a tube that is configured to enter the trachea through the mouth to provide oxygenated air and / or other gases and medications to the patient's lungs. The endotracheal tube 102 may include a soft polyvinyl chloride (PVC) material. Although the endotracheal tube 102 is described herein, the sleeve assembly 100 may be implemented in conjunction with any suitable medical device, including but not limited to a tracheotomy tube or other airway tube, a catheter, a stent, and / or a feeding tube.

[0056] Typically, the cuff assembly 100 is adhesively or otherwise disposed toward the distal end of the endotracheal tube 102. The cuff assembly 100 includes a first annular or donut-shaped inner cuff 104 positioned around and adjacent to the endotracheal tube 102. The inner cuff 104 is inflatable and is configured to expand radially from the endotracheal tube 102. A second donut-shaped outer balloon 106 is positioned around and adjacent to the inner cuff 104, wherein at least a portion of the inner cuff 104 is located between the outer balloon 106 and the endotracheal tube 102. The outer balloon 106 is configured to expand radially from the inner cuff 104 such that an outer surface of the outer balloon 106 contacts the tracheal wall. In an embodiment, as shown in FIG. Figure 1As shown, the top surface 114 of the outer balloon 106 can extend over the top surface of the inner cuff 104 and be sealed at a junction 116 with the inner cuff 104 and / or with the endotracheal tube 102. A strap 118 can secure and / or attach the cuff assembly 100 to the endotracheal tube 102.

[0057] The inner sleeve 104 includes a relatively elastic material, and the outer bladder 106 includes a relatively inelastic material, for example, the elasticity of the material of the outer bladder is less than the elasticity of the material of the inner sleeve 104. For example, the relatively elastic material of the inner sleeve may include 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 bladder 106 may include 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 bladder 106 and the inner cuff 104 are configured to expand and maintain different pressures. The relatively elastic inner cuff is configured to operate in an expanded state at lower pressures, such as in a pressure range of 10 cm H2O to 20 cm H2O. In contrast, the less elastic or relatively inelastic outer bladder is configured to operate in an expanded state at a higher pressure range of 50 cm H2O to 150 cm H2O.

[0059] In use, for example, when inserted into the trachea and subsequently pressurized to an expanded state, the first inner cuff 104 behaves as a HVLP-type balloon, while the second outer balloon 106 behaves as a LVHP-type balloon. The more compliant inner cuff 104 is able to adjust the pressure ("tracheal pressure") exerted on the tracheal wall by the more highly pressurized outer balloon 106. In other words, the lower pressure, more elastic inner cuff 104 is configured to absorb excess pressure that might otherwise be exerted on the tracheal wall by the outer balloon 106. For example, because the inner cuff 104 is more compliant and elastic, the cuff assembly 100 exerts a lower total pressure / force on the tracheal wall, e.g., lower than the outer balloon pressure. The force of the inner cuff 104 acts radially on the outer balloon 106 and is therefore the force that is ultimately exerted on the trachea as the tracheal pressure. Therefore, the radial force generated by the inner cuff 104 and acting on the outer balloon 106 is the tracheal pressure. For example, when the pressure within the cuff of the outer balloon is greater than the pressure within the cuff of the inner cuff, and the outer balloon is inflated so that the outer surface contacts the trachea, the pressure within the cuff of the inner cuff is the same as the tracheal pressure.

[0060] In addition, the outer balloon 106 in the expanded state forms a relatively smooth surface with fewer wrinkles or folds, for example, compared to an LVHP cuff. This reduction in wrinkles reduces the risk of leaks and creates a more uniform tracheal seal.

[0061] In this way, 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 utilizes the advantages found in both types of cuffs: excellent tracheal seal with greater safety to the trachea. The cuff system 100 features an excellent seal to the tracheal wall with reduced tracheal trauma. Thus, the cuff assembly 100 helps protect the lungs from contamination with orogastric contents or blood without causing undue damage to the tracheal wall.

[0062] In embodiments, the cuff assembly 100 may further include a secretion collection system implemented to collect and remove aspirate or other fluids that may 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 rear side of the endotracheal tube 102. A catheter guide 112 may enclose the catheter 110 on the outer surface of the tube 102.

[0063] Figure 2 The cuff system 100 is illustrated with a cross-section of the outer balloon 106. In this embodiment, the outer balloon 106 is a separate structure, e.g., having walls separate from the inner cuff 104 and the endotracheal tube 102. The outer balloon 106 includes an inner surface 210 and an outer surface 204. The inner surface 210 of the balloon 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 balloon 106 is configured to be inflated and deflated through a first lumen 218 that communicates with the outer balloon 106 through an opening 222 formed in the lumen 218. The lumen 218 may be positioned 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 extending from an outer surface 214 of the cuff wall. These bands 212a, 212b are sized to accommodate the endotracheal tube 102. The proximal band 212a is located farther from the distal end of the endotracheal tube 102, while the distal band 212b is located closer to the distal end of the endotracheal tube 102. The bands 212a, 212b help couple the inner cuff 104 to the endotracheal tube 102, and may also be attached to the endotracheal tube 102 using adhesive, heat, or by other means.

[0066] The inner cuff 104 is configured to be inflated and deflated via a second lumen 220 that 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 may be positioned inside or attached to the inside or outside of the endotracheal tube 102 and extends 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. Although described using the endotracheal tube 102, the sleeve assembly 100 provided herein may 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] FIG. 3A to FIG. 3B A cross-sectional view of an embodiment of a sleeve system 100 is illustrated. Figure 3A A top cross-sectional view of the sleeve system 100 is illustrated, Figure 3B A side cross-sectional view of the sleeve system 100 is illustrated. Figure 3A As shown, the outer bladder 106 is an inflatable toroidal or ring-shaped independent structure having an outer surface 204 and an inner surface 210. Similarly, the inner sleeve 104 is an inflatable toroidal or ring-shaped independent structure having an outer surface 214 and an inner surface 302.

[0069] The inner surface 210 of the outer balloon 106 is proximate and / or attached to the outer surface 214 of the inner cuff 104. The inner surface 302 of the inner cuff 104 is proximate 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 balloon 106 and the endotracheal tube 102.

[0070] In an embodiment, if Figure 1 As shown, the proximal surface 306 of the outer balloon 106 extends to the inner sleeve 104 and is sealed at the connection with the top surface 318 of the inner sleeve 104 and / or with the endotracheal tube 102. Therefore, the proximal surface 306 of the balloon 106 prevents leakage between the inner sleeve 104 and the outer balloon 106. Alternatively or additionally, the outer surface 214 of the inner sleeve 104 can be attached to form a seal to prevent leakage or pressed against the inner surface 210 of the outer balloon 106, for example, so that secretions or other substances cannot leak through the joint. For example, the inner sleeve 104 and the outer balloon 106 can be attached adhesively or using a heating process or a combination thereof.

[0071] In addition, 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 heating process or a combination thereof. These seals or attachments prevent secretions from leaking between the endotracheal tube 102 and the inner cuff 104.

[0072] exist Figure 2 and the Figure 3B In another embodiment shown, the secretion collection container 108 can be formed by using the outer surface 204 of the outer balloon 106 to form a wall 316. For example, a portion of the outer surface 204 of the outer balloon 106, such as at the proximal side of the sleeve assembly 100, extends upward from the proximal surface 318 of the inner sleeve 104. The proximal surface 306 of the outer balloon 106 can be inclined inwardly from the wall 316 toward the proximal top surface 318 of the inner sleeve 104 to form a valley or groove around at least a portion of the circumference of the endotracheal tube 102 (e.g., at least on the rear side of the endotracheal tube 102). This valley or groove of the secretion collection container 108 collects secretions or particles, which can be removed using the suction catheter 110 as further described herein. In the embodiment shown in FIG. Figure 2 and Fig. 11B In another embodiment shown, the wall 316 of the outer bladder 106 is not inclined at an angle. The outer surface 204 of the outer bladder 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 sleeve 104.

[0073] Figure 3C and Figure 3D Another embodiment of the cuff system 100 is illustrated in which the outer surface 304 of the endotracheal tube 102 is used at least in part to form the inner cuff 104. 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 an airtight seal. For example, the outer surface 214 of the inner cuff can form a band 212a, 212b that surrounds the endotracheal tube 102 to form an airtight seal with the endotracheal tube 102.

[0074] FIG. 3A to FIG. 3D One or more features of the various embodiments described herein may be used in any embodiment shown herein.

[0075] Figure 4A cross-sectional view of the cuff assembly 100 implemented with the endotracheal tube 102 is illustrated. In an embodiment, the inner cuff inflation tube 220 and the outer balloon 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 balloon inflation tube 218 are located in or on the interior or exterior of the endotracheal tube 102, such as attached to the inner wall 410 of the endotracheal tube 102. In another embodiment, the inner cuff inflation tube 220 and the outer balloon inflation tube 218 are located on the outer surface 304 of the endotracheal tube 102.

[0076] In an embodiment, the catheter guide 112 is positioned on the rear side 408 of the endotracheal tube 102, proximal to the secretion collection container 108. The catheter guide 112 then extends circumferentially around the endotracheal tube 102 to be disposed on the front side 406 of the endotracheal tube 102 at the proximal end of the catheter 102. The suction tube 110 is located within the catheter guide 112 and can be replaced in the event of an obstruction or other malfunction.

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

[0078] Furthermore, in an embodiment, the width W of the outer bag is OB and the inner sleeve width W IC For example, the width W of the outer capsule OB and the inner sleeve width W IC In other embodiments, the width W of the outer capsule is about 6 mm. OB Or the width of the inner sleeve W IC It may be different, for example, the inner sleeve 104 may be wider or narrower than the outer bladder 106. The inner sleeve 104 and the outer bladder 106 may have a thickness of less than about 0.00086 inches (0.022 mm).

[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 sleeve assembly 100 can be implemented with other endotracheal tubes having alternative sizes or with other medical devices having various sizes and dimensions. In addition, the exemplary dimensions and dimensions of the sleeve 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 more detail. The tip 224 is located 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 inclined walls, for example, the walls 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 sleeve assembly 100 provides an improved seal to the tracheal wall because the higher pressure outer balloon 106 forms a relatively smooth surface with fewer folds or wrinkles than, for example, an HVLP sleeve. In addition, the lower pressure inner sleeve 104 produces a low total pressure on the tracheal wall through the sleeve assembly 100, such as similar to or less than the pressure of a typical HVLP sleeve, but with an improved seal to the tracheal wall. Therefore, the tracheal mucosa is subjected to a low total pressure and the risk of ischemic injury is lower. The sleeve assembly 100 also has a smaller volume than an HVLP sleeve, making it easier to intubate the patient.

[0082] Implementation of the pressure regulation system

[0083] Compared to the tube itself, the benefits and risks of endotracheal tubes rely on maintaining a predetermined pressure range in the cuff assembly. For example, overinflation of the cuff assembly may cause damage to the tracheal mucosa, resulting in ischemic damage and vocal cord nerve damage. The damage is due to the constant pressure applied by the cuff to prevent blood from flowing to the tracheal mucosa. This blood loss may cause tissue necrosis. In addition, damage may also occur due to repeated wear and tear of the cuff moving on the tracheal wall. When the cuff is under-inflated and the tracheal seal is not sufficient, the patient may not receive enough oxygen. In addition, the patient has an increased likelihood of pneumonia due to aspiration of orogastric contents. Therefore, maintaining the pressure of the cuff assembly 100 of the endotracheal tube 102 is a key part of patient care, reducing tracheal damage and preventing ventilator-associated pneumonia (VAP).

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

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

[0086] The force of the inner cuff 104 acts radially on the outer balloon 106, and is therefore the force that is ultimately applied to the tracheal wall as tracheal pressure. Therefore, the radial force generated by the inner cuff 104 and acting on the outer balloon 106 is the generated tracheal pressure. For example, when the intra-cuff pressure of the outer balloon is greater than the intra-cuff pressure of the inner cuff 104, and the outer balloon 106 is inflated so that the outer surface 204 contacts the tracheal wall, the radial force that the inner cuff 104 acts on the outer balloon 106 is the final pressure acting on the tracheal wall. Because the inter-cuff pressure sensor device 602 is positioned between the inner cuff 104 and the outer balloon 106, it measures the radial force that the inner cuff 104 acts on the outer balloon 106. In this way, the pressure sensor 602 measures the tracheal pressure, such as the pressure applied by the cuff assembly 102 on the tracheal wall.

[0087] In an embodiment, the sleeve 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 sleeve pressure sensor device 602 transmits the pressure measurement results 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 use the wireless transmitter to wirelessly transmit the pressure measurement results to the pressure adjustment system.

[0088] Additional pressure sensor devices may be positioned within the cuff assembly. For example, a pressure sensor device may be positioned within the inner cuff 104 to measure the intra-cuff pressure within the inner cuff 104. Additionally, a pressure sensor device may be positioned within the outer bladder 106 to measure its pressure. Additional pressure sensor devices may be positioned on the outer surface of the bladder 106 to measure tracheal pressure. Additional pressure sensor devices may be positioned within the endotracheal tube 102 or at the tip 224 of the endotracheal tube 102 to measure the pressure of oxygenated air delivered to the patient.

[0089] Figure 7An exemplary embodiment of an endotracheal tube 102 having a cuff assembly 100 is illustrated. A lead guide 606 and a 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 pressure measurements and / or power supply.

[0090] The first sight balloon 704 is attached at the distal end to the first lumen 218, wherein the first lumen 218 is fluidly coupled to the outer balloon 106. The first sight balloon 704 expands with the outer balloon 106 and can serve as an indicator of the pressure in the outer balloon 106 and whether the outer balloon 106 is inflated.

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

[0092] The proximal ends of the first sighting balloon 704 and the second sighting balloon 706 include a first adapter 708 and a second adapter 710. The first adapter 708 and the second adapter 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 a cuff assembly 100 is illustrated. The regulator system 800 is in fluid communication with the cuff assembly 100 and inflates the cuff assembly 100 and regulates the pressure within the cuff assembly 100, such as when an endotracheal tube 102 is implanted in the trachea of ​​a patient. The pressures of the inner cuff 104 and outer cuff 106 of the cuff assembly 100 are monitored and controlled, respectively.

[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 storing 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, 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 manipulates signals (analog and / or digital) based on hard coding of circuits and / or operating instructions. The memory device 810 includes a non-transitory memory device and can be an internal memory or an external memory and can be a single memory device or a plurality of memory devices. The memory device 810 may be a read-only memory, random access memory, volatile memory, nonvolatile 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, touch screen, mouse, touch pad, gauges, switches, or other I / O devices.

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

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

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

[0099] Thus, the pneumatic system 820 includes separate pneumatic pathways to independently and separately fluidly increase or decrease the pressure in the air cuff 104 and the outer bladder 106. The pneumatic pathways may include separate air pumps 822a, 822b or a single air pump along with a valve that switches between the pneumatic pathways for the outer bladder 106 and for the inner cuff 104.

[0100] In operation, the pressure controller 806 receives pressure measurements from one or more pressure sensor devices to adjust the pressure of the cuff assembly 100. For example, the intercuff pressure sensor device 602 is positioned between the inner cuff 104 and the outer bladder 106 and measures the radial force of the inner cuff 104 on the outer bladder 106. Another inner cuff pressure sensor device 802 can be positioned within the inner cuff 104 to measure the intracuff pressure. The outer bladder pressure sensor device 804 can be positioned to measure the pressure within the outer bladder 106. An additional outer cuff 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 pressure measurements and transmit them to the pressure controller 806, for example, via wired leads and / or wireless transmitters.

[0101] The regulator system 800 includes a pressure feedback loop in which a pressure controller 806 controls a 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 pressures of the inner cuff 104 and the outer bladder 106 are monitored and controlled separately. The pressure controller 806 sends a signal 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 may signal an air pump 822a to add air to the outer bladder 106, or a 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 may signal an air pump 822b to add air to the inner cuff 104, or a 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, firstly adjusting the pressure of the outer bladder 106 and secondly adjusting the pressure of the inner cuff 104, to achieve a predetermined pressure setting, such as pre-selected by an operator or by 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 a visual and / or audible alarm in the event of an unsafe pressure measurement.

[0103] Fig. 9 A flow chart illustrating an embodiment of one or more methods 900 for monitoring and controlling the pressure of a cuff assembly 100, for example, by a regulator system 800. At step 902, one or more pressure measurements related to 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 on the tracheal wall by the cuff assembly 100) is within a predetermined pressure range. The pressure measurements may come from the intercuff 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 may control the release valve 824b to release air from the inner cuff 104. Because tracheal mucosal blood flow may be compromised when applied pressure is above 30 cm H2O (22 mmHg), the regulator system 800 may 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, the regulator system 800 increases the pressure in at least the inner cuff 104 at step 906. For example, the regulator system 800 may control the air pump 822b to pump air into the inner cuff 104. In addition, the pressure of the outer bladder 106 may also be adjusted. These steps may be performed at preset time intervals or continuously.

[0105] At step 908, one or more pressure measurements related to the external bladder pressure are obtained from one or more pressure sensor devices by the regulator system 800. At step 910, the regulator system 800 determines whether the pressure of the external bladder 106 is within a predetermined pressure range using these pressure measurements. For example, the pressure measurements may come from a pressure sensor device 804 located within the external bladder 106 or at a sighting balloon 704 for the external bladder 106. When the external 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 external bladder 106. For example, the regulator system 800 may control the air pump 822a to pump air into the external bladder 106 when its pressure is below the predetermined pressure range, or control the release valve 824a to release air from the external bladder 106 when its pressure is above the predetermined pressure range. The external bladder 106 may have a predetermined pressure range of 50 cmH2O to 150 cmH2O.

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

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

[0108] An intra-cuff pressure sensor 602 between the inner cuff 104 and the outer bladder 106 provides tracheal pressure measurements. A pressure controller 802 can independently adjust the pressure of the inner cuff 104 and / or the outer bladder 106 to regulate tracheal pressure, such as when tracheal pressure exceeds an unsafe threshold or falls below a threshold.

[0109] Therefore, the sleeve assembly 100 and the adjuster system 800 help reduce microaspiration and lung infection by maintaining a good seal with the tracheal wall, but without unduly damaging the tracheal wall. The system provides an improved airway seal with minimal damage to the airway.

[0110] Embodiments of the secretion removal system

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

[0112] In MV patients, 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 secretions are the oral cavity, sinuses, and stomach ("orogastric secretions"). It is known that under normal conditions, the oral cavity and sinuses produce up to 3 liters of secretions per day. Again, this does not include gastric reflux, which can be an important factor. While healthy people are able to eliminate and / or control secretions, ventilated patients are not. In contrast, in ventilated patients, secretions in the trachea accumulate above the ETT cuff or leak through the ETT cuff and into the trachea and lungs.

[0113] The concern with secretions accumulating above the ETT cuff is that the secretions carry microorganisms, including bacteria and fungi. Because secretions are highly 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 secretions from leaking into the patient's lungs.

[0114] The ETT cuff can be a powerful aspirate arrest mechanism. When inflated, the ETT cuff should be in circumferential contact with the tracheal wall, thereby forming a complete seal. Unfortunately, known ETT cuffs do not provide an effective seal, primarily due to wrinkles or folds formed by oversized cuffs as described above.

[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 secretions that leak 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 sheer pressure of the secretions will likely eventually cause secretions to leak into the lungs. Therefore, in addition to effective tracheal occlusion, an effective method for clearing secretions is also needed.

[0116] Current systems for clearing secretions include a suction tube near the proximal end of the ETT sleeve. However, the configuration of the suction tube opening is known to cause direct injury and suction trauma to the tracheal mucosa. The suction tube opening is configured so that it is easily occluded by the sleeve wall. In addition, due to its small size, the suction tube is easily occluded. A larger suction tube may increase the volume of the endotracheal tube, which is sufficient to make the intubation process more difficult. In addition, when the suction tube is integrated into the ETT, and the suction tube is occluded, the entire ETT and ETT sleeve must be replaced. Therefore, there is a need for an improved secretion removal system.

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

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

[0119] The catheter 110 is preferably a thin-walled, non-collapsible and flexible hollow channel or tube. The catheter 110 is configured to empty the container 108, so at least the tip 1004 of the catheter 110 is positioned in or adjacent to the container 108. The catheter tip 1004 is located behind the endotracheal tube 102 and the ETT cuff 1002. Therefore, the catheter tip 1004 is in a more advantageous position to aspirate and remove secretions that tend to accumulate on the back of the trachea and on the container 108 in a prone and intubated patient.

[0120] The catheter guide 112 surrounds the aspiration catheter 110 to provide protection for the catheter 110. The preformed channel of the catheter guide 112 is externally positioned on the outer surface of the ETT 102. At the proximal end 402 of the ETT 102, the catheter guide 112 extends along the front side 406 of the outer surface of the ETT 102. At the distal end 404 of the ETT 102, the catheter guide 112 extends around half of the circumference of the ETT 102 to the rear side 408 of the distal end 404 of the ETT 102.

[0121] The intubated patient in the prone position includes an opening on the front side of the trachea between the vocal cords. Since the catheter guide 112 is positioned on the front side of the ETT 102 at the proximal end 402, the catheter guide 112 can be placed in this opening for the vocal cords without applying undue pressure to the trachea. Due to this positioning between the vocal cords, the catheter guide 112 and the suction catheter 110 can have an increased diameter. The larger diameter in the catheter 110 can help prevent occlusion. In one example, the catheter 110 can have an inner diameter of about 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 catheter guide 112 and the catheter 110 are rotated half a circle around the ETT 102 to the back side 408 of the ETT 102 to improve the collection of secretions that tend to accumulate on the trachea and the back side of the ETT cuff 1002. The catheter guide 112 can extend into or near the collection container 108. The catheter tip 1004 extends into or near the collection container 108. In one example, the catheter 110 and the tip 1004 include a semi-rigid material, such as one or more of the following materials: polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU). The size of the catheter 110 can be between 7 and 12 French, such as a circumference of 7.33 mm to 12.57 mm. In an embodiment, the tip 1004 of the catheter includes at least two openings, for example, one opening on each of opposing sides of the tip 1004, to reduce the likelihood of catheter occlusion.

[0123] Fig. 10B An embodiment of the proximal end of the aspiration catheter 110 and the catheter guide 112 is illustrated in more detail. In an embodiment, the catheter 110 includes a depth indicator 1100 that provides an indication of the correct positioning of the catheter 110 in the catheter guide 1102. The depth indicator 1100 may include markings that serve as a guide. In another embodiment, the depth indicator 1100 is a raised ridge that prevents the catheter 110 from being inserted further into the catheter guide 112.

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

[0125] Fig.11A and Fig. 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 portion of an inner wall 1124 of the endotracheal tube 102 and a longitudinal baffle 1120 extending through the portion of the inner wall 1124. The segments of the inner wall 1124 and the longitudinal baffle 1120 are positioned on the rear 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 in the endotracheal tube 102 beside or near the secretion container 108.

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

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

[0128] FIG. 12A to FIG. 12C Schematic block diagrams of various embodiments of secretion collection containers 108 implemented in conjunction with a sleeve assembly 100 (e.g., including an inner sleeve 104 and an outer bladder 106) are illustrated. Fig. 12A , the secretion collection container 108 is formed using the outer surface 204 of the outer balloon 106. For example, a portion of the outer surface 204 of the outer balloon 106 (e.g., on the proximal surface 306 of the outer balloon 106) extends beyond the outer surface 214 of the inner cuff 104 to form an outer wall. The proximal end 306 of the outer balloon 106 can be inclined inwardly toward the outer surface 214 of the inner cuff 104 to form a valley or groove around the endotracheal tube 102. The valley or groove forms the secretion collection container 108. The bottom surface of the collection container 108 is defined by the proximal surface of the inner cuff 104, which can be reinforced with a harder, less elastic material than other portions of the inner cuff 104, or not reinforced.

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

[0130] Fig. 12BAn embodiment is illustrated wherein the proximal surfaces 306, 310 of the outer balloon 106 and inner cuff 104 slope inwardly 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 a secretion collection reservoir 108.

[0131] exist Fig. 12C , on the rear side 408 of the ETT 102, a separate structure 1200 attached to the proximal end of the sleeve assembly forms the secretion collection container 108. The separate structure 1200 may be attached to one or both of the inner sleeve 104 and the outer bladder 106. The separate structure 1200 may include an inclined top surface 1202 that slopes inwardly toward the outer surface 304 of the ETT 102 to form a valley or groove.

[0132] FIG. 13A to FIG. 13B Schematic block diagrams of various embodiments of secretion collection containers 108 implemented in conjunction with other types of ETT cuffs 1002 are illustrated. Other types of ETT cuffs 1002 may include, for example, HVLP or LVHP cuffs having a single balloon, or may include other types of medical cuffs, such as for use with stents or other medical devices.

[0133] exist Fig.13A 1002, the receptacle 108 is formed by at least a portion of an outer wall 1304 of the ETT sleeve 1002, for example, at a proximal end 1306 of the ETT sleeve 1002. The outer wall 1304 extends beyond the inner wall 1302 and may slope toward the outer surface 304 of the ETT 102 to form a valley or groove around the ETT 102. The valley or groove forms the secretion collection receptacle 108.

[0134] exist Fig. 13B 1002 (e.g., on the rear side 408 of the ETT 102) forms the secretion collection container 108. The separate structure 1310 may include an inclined top surface 1308 that slopes inwardly toward the outer surface 304 of the ETT 102 to form a valley or groove.

[0135] exist FIG. 12A to FIG. 1 2D and FIG. 13A to FIG. 13BIn these embodiments, the secretion collection container 108 can completely or only partially surround the ETT 102. The tip of the suction catheter 110 is located within or very close to the groove of the secretion collection container 108. The collection container 108 helps protect the tracheal wall from suction trauma or direct damage from the suction catheter 110. In addition, the catheter guide 112 maintains the tip of the suction catheter 110 near the outer surface 304 of the ETT 102 and in a position inside or close to the collection container 108. This positioning of the tip of the catheter 110 also helps protect the tracheal wall.

[0136] Thus, the secretion clearing system 1000 helps reduce the possibility of damaging the tracheal mucosa. It also helps reduce the obstruction of the cuff wall to the opening in the tip 1004 of the catheter 110, for example, helping to prevent the cuff from being sucked into the catheter 110. The retractable catheter 110 in the catheter guide 112 makes intubation of the ETT 102 less cumbersome. In addition, due to the placement of the catheter guide, a larger diameter catheter 110 can be used, which reduces the chance of occlusion.

[0137] The sleeve assembly 100, the regulator system 800 and the secretion removal system 1000 improve the protection and safety of the intubated patient. The sleeve system 100 and the regulator 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 possibility of damaging the tracheal mucosa by using the secretion container 108 and the catheter guide 112. It also helps to reduce the obstruction of the opening in the top 1004 of the catheter 110 by secretions or the material of the sleeve. 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 "operably" or "configurably" represents that an element includes one or more of a circuit, instruction, module, data, input, output, etc., to perform one or more of the described or necessary corresponding functions, and may also include an inference connection with one or more other items to perform the described or necessary corresponding functions. As may also be used herein, the term "connection", "connected to", "connected to" and / or "connection" or "interconnection" includes a direct connection or link between nodes / equipment and / or an indirect connection between nodes / equipment via an intermediate item. As may further be used herein, the inferred connection (that is, one of the elements is connected to another element by inference) includes a direct and indirect connection between two items in the same manner as "connected to". As used herein, the terms "substantially" and "approximately" provide an industrially acceptable tolerance for the relativity between its corresponding terms and / or items.

[0139] Note that various aspects of the present disclosure may be described herein as processes depicted as schematic diagrams, flow charts, flow diagrams, structure diagrams, or block diagrams. Although a flow chart may describe an operation as a sequential process, many operations may be performed in parallel or simultaneously. In addition, the order of the operations may be rearranged. When the operations of a process are completed, the process terminates. A process may correspond to a method, function, process, subroutine, subprogram, etc. When a process corresponds to a function, its termination corresponds to returning the function to a calling function or a main function.

[0140] The various features of the present disclosure described herein may be implemented in different systems and devices without departing from the present disclosure. It should be noted that the foregoing aspects of the present disclosure are merely examples and should not be construed as limiting the present disclosure. The description of the various aspects of the present disclosure is intended to be illustrative rather than limiting the scope of the claims. Similarly, the present invention may be easily applied to other types of devices, and many substitutions, modifications, and variations will be apparent to those skilled in the art.

[0141] In the foregoing description, certain representative aspects have been described with reference to specific embodiments. However, various modifications and changes may be made without departing from the scope of the invention as set forth in the claims. The description and drawings are illustrative rather than restrictive, and modifications are intended to be included within the scope of the invention. Therefore, the scope of the invention should be determined by the claims and their legal equivalents, rather than merely by the examples described. For example, the components and / or elements described in any device claim may be assembled or otherwise operably configured in various arrangements, and are therefore not limited to the specific configurations described in the claims.

[0142] Furthermore, certain benefits, other advantages, and solutions to problems have been described above with respect to particular embodiments; however, any benefit, advantage, solution to problems, or any element that may cause any particular benefit, advantage, or solution to occur or become more significant should not be construed as a critical, required, or essential feature or component of any or all the claims.

[0143] As used herein, the words "comprises," "comprising," "having," "containing," or any variation thereof, are intended to represent non-exclusive inclusion, such that a process, method, article, composition, or apparatus that includes a list of elements includes not only those elements that are listed, but may also include other elements not expressly listed or inherent to such processes, methods, articles, compositions, or apparatuses. Other combinations and / or modifications of the above-described structures, arrangements, applications, proportions, elements, materials, or components used in the practice of the present invention, except those not specifically described, may be varied or otherwise specifically adapted to specific environments, manufacturing specifications, design parameters, or other operating requirements without departing from the general principles of the present invention.

[0144] In addition, unless otherwise specified, referring to an element in the singular does not mean "one and only one", but rather "one or more". Unless otherwise explicitly stated, the term "some" refers to one or more. All structural and functional equivalents of the elements of the various aspects described throughout this disclosure are known or will be known to those of ordinary skill in the art, and these equivalents are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly stated in the claims. Under 35 U.S.C. §112(f), no claim element is intended to be interpreted as a "means plus function" type element unless the element is explicitly stated using the phrase "means for..." or, in the case of a method claim, the phrase "step for..." is used to state the element.

Claims

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

2. The medical device according to claim 1, wherein: The inner cuff is configured to be inflated within a first pressure range and the outer bladder is configured to be inflated within a second pressure range, wherein the first pressure range is lower than the second pressure range.

3. The medical device according to claim 2, wherein: The inner cuff is configured to be inflated to a pressure in the range of 10 cm H2O to 20 cm H2O, and the outer bladder is configured to be inflated to a pressure in the range of 50 cm H2O to 150 cm H2O.

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

5. The medical device according to claim 1, further comprising: A first inflatable lumen connected to the interior of the inner sleeve; as well as A second inflation lumen is coupled to the interior of the outer balloon.

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

7. The medical device according to claim 1, wherein: The outer bag 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.

8. The medical device according to claim 1, further comprising: A pressure regulator, the pressure regulator being configured to: regulating a first pressure in the inner cuff using a first pneumatic path; as well as A second pressure within the outer bladder is adjusted using a second, different pneumatic path, wherein the first pressure within the inner cuff is less than the second pressure within the outer bladder.

9. The medical device according to claim 8, further comprising: A pressure sensor device positioned between the inner cuff and the outer bladder, wherein the pressure sensor device measures inter-cuff pressure.

10. The medical device according to claim 9, wherein: 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.

11. A cuff assembly for a tracheal airway cannula, the cuff assembly comprising: an inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned adjacent the endotracheal airway tube, and wherein the inner cuff is configured to be inflated within a first pressure range; and An inflatable outer bladder is positioned adjacent the outer surface of the inner sleeve, wherein the outer bladder is configured to be inflated within a second pressure range, wherein the first pressure range is lower than the second pressure range.

12. The sleeve assembly of claim 11, further comprising: a first lumen extending from the endotracheal airway tube to the inner cuff, wherein the first lumen is fluidly coupled to the inner cuff; and A second lumen extends from the endotracheal airway tube to the outer balloon, wherein the second lumen is fluidly coupled to the outer balloon.

13. The sleeve assembly of claim 12, further comprising: 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 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 outer bladder, wherein the first pressure is less than the second pressure.

14. The sleeve assembly of claim 13, wherein: The pressure regulator system comprises: a first air pump and a first release valve fluidly coupled to the first lumen and configured to add air 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 air or remove air from the outer balloon.

15. The sleeve assembly of claim 13, further comprising: a pressure sensor device positioned between the inner cuff and the outer bladder, wherein the pressure sensor device measures inter-cuff pressure; and wherein the pressure regulator 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.

16. The sleeve assembly of claim 11, further comprising: a secretion collection container positioned at the proximal end of the sleeve assembly; A suction channel includes a distal end proximal to the secretion collection container and a proximal end of the suction channel at a proximal end of the endotracheal airway tube, wherein the proximal end of the suction channel is in communication with a vacuum fluid.

17. The sleeve assembly of claim 16, wherein: The secretion collection container comprises: An outer wall of the cuff assembly, extending proximally from a proximal surface of the cuff assembly, forms a groove for collecting secretions, wherein the groove is positioned at least on a rear side of the endotracheal airway tube.

18. The sleeve assembly of claim 16, wherein: The suction channel includes a catheter, and the sleeve assembly further includes: a catheter guide configured to hold the catheter, wherein the catheter guide is positioned on a front side of an outer surface at a proximal end of the endotracheal tube; and wherein 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.

19. A medical device, comprising: an airway tube configured to fit within the trachea; A sleeve assembly is implemented at the lower end of the airway tube, and the sleeve assembly includes: an inflatable inner cuff having an inner surface and an outer surface, wherein the inner surface is positioned adjacent the airway tube, and wherein the inner cuff has a first elasticity; an inflatable outer bladder positioned adjacent 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 pressure regulator, the pressure regulator being configured to: setting a first pressure for the inner sleeve; and A second pressure for the outer bladder is set, wherein the first pressure for the inner sleeve is less than the second pressure for the outer bladder.

20. The medical device according to claim 19, comprising: a first inflation lumen coupled to inflate the inner cuff; as well as A second inflation lumen is coupled to inflate the outer balloon.

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