System and method for a cuff assembly of an endotracheal tube

Abstract

The cuff assembly for the airway tube includes an outer bladder and an inner cuff. The inner cuff is disposed adjacent to the airway tube, and the outer bladder is disposed adjacent to the inner cuff. The outer bladder is made of a less elastic material and operates at a higher relative pressure. The inner cuff is made of a more elastic material or a superelastic material and operates at a lower relative pressure. The pressure controller independently adjusts the pressures within the inner cuff and the outer bladder. The secretion collection receptacle is formed by the cuff assembly and is discharged via a suction catheter or channel.

Description

Technical Field

[0001] The present application relates to systems and methods for a cuff assembly implemented in a medical device, and more particularly to a cuff assembly implemented within an airway tube, a pressure regulation system for the cuff assembly, and a secretion removal system.

[0002] Priority Claim This application claims the priority and benefit of Patent Application No. 17 / 848,273, filed with the United States Patent and Trademark Office on June 23, 2022, the entire content of which is hereby incorporated by reference herein for all applicable purposes as if fully set forth below.

Background Art

[0003] Currently, there are mainly two types of cuffs: low-volume high-pressure (LVHP) cuffs and high-volume low-pressure (HVLP) cuffs. The first type, LVHP cuffs, are made of a hard and relatively non-elastic material. Due to their inherent hardness, a higher pressure (50 cmH2O to 100 cmH2O) is required to inflate the LVHP cuff. As a result, even when the LVHP cuff is inflated at the minimum pressure to ensure sealing with the tracheal wall, it will apply an overly high pressure to the tracheal mucosa. This high pressure causes an unacceptably high incidence of tracheal ischemia and necrosis, for example, up to 5% - 20%. However, one of the important advantages of the LVHP cuff when inflated is that it has relatively few folds and wrinkles, resulting in excellent tracheal sealing. LVHP cuffs were first adopted in the 1960s but are now widely replaced by HVLP cuffs.

[0004] The HVLP cuff is composed of a more elastic compliant material and inflates at a lower pressure. To compensate for this low-pressure characteristic and ensure sealing with the tracheal wall, the diameter of the HVLP cuff is usually 1.5 to 2 times the diameter of the trachea when fully inflated. However, as the volume of the HVLP cuff increases, a large amount of cuff material is required, and the HVLP cuff bulges, making intubation more difficult. Furthermore, wrinkles and folds are likely to occur in the excess material due to "incomplete inflation". These wrinkles and folds facilitate the passage of oral and gastric secretions past the HVLP cuff, ultimately leading to aspiration and pulmonary infections in small amounts.

[0005] When examining the effect of cuff pressure on the trachea, it is important to keep in mind that the capillary perfusion pressure of the tracheal wall mucosa in humans ranges from 22 to 32 mmHg, and blood flow in the tracheal mucosa is inhibited when a pressure exceeding 30 cmH2O (22 mmHg) is applied, and blood flow to specific sites is completely blocked at 50 cmH2O (37 mmHg). Therefore, it is clear that there is only a small overlap between the safe pressure range and the range of complication occurrence. The range of effectiveness and safety is actually very narrow or does not exist.

[0006] In a general HVLP cuff, the pressure required to inflate it moderately so that the number of folds and wrinkles is within an acceptable range is approximately 32 cmH2O. Guidelines established by various medical societies and organizations recommend maintaining the HVLP cuff pressure within the range of 20 cmH2O to 30 cmH2O to avoid blood flow obstruction in the tracheal mucosa. However, even when strictly following the recommendations, many patients are still at risk. In fact, in one study, approximately 10% of patients using mechanical ventilation developed ventilator-associated pneumonia (VAP), and the mortality rate of VAP is estimated to be 13%. Furthermore, patients who develop VAP have a longer hospital stay and higher medical costs than patients with similar medical conditions who do not develop VAP. Considering that there are approximately 750,000 patients in the United States who require mechanical ventilation annually, the human and economic burden due to VAP is enormous.

[0007] Unfortunately, studies have shown that even at pressures up to 60 cmH2O, there is still a small amount of aspiration with an HVLP cuff, and it has been suggested that even at higher pressures, wrinkles remain in the cuff and there is a possibility of secretions passing through. Therefore, although the HVLP cuff appears to be excellent because it can ensure sealing at lower pressure levels and avoid tracheal wall necrosis, it still falls far short of the ideal.

[0008] The main purpose of a tracheal cuff is to provide maximum sealing of the trachea and minimize damage to the airway. This is simple and straightforward, but it has been difficult to achieve these purposes successfully. This situation continues despite various modifications and advancements regarding materials, shape, and volume structure. Therefore, there is a need for an improved cuff system that helps reduce minor aspiration and lung infections by maintaining a good seal with the tracheal wall without overly damaging the tracheal wall.

Summary of the Invention

[0009] In one aspect, a medical device includes an airway tube configured to fit within the trachea and a cuff assembly mounted on the distal portion of the airway tube. The cuff assembly includes an inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the airway tube, and the inner cuff having a first elasticity. An inflatable outer bladder is disposed adjacent to the outer surface of the inner cuff, and the outer bladder has a second elasticity that is less than the first elasticity of the inner cuff.

[0010] In another aspect, a cuff assembly for a tracheal airway tube includes an inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the tracheal airway tube, and the inner cuff being configured to inflate within a first pressure range. The cuff assembly further includes an inflatable outer bladder disposed adjacent to the outer surface of the inner cuff, the outer bladder being configured to inflate within a second pressure range, and the first pressure range being less than the second pressure range.

[0011] In another aspect, the medical device includes an airway tube configured to fit within the trachea and a cuff assembly mounted at the lower end of the airway tube. The cuff assembly includes an inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the airway tube, and the inner cuff having a first elasticity. The cuff assembly also includes an inflatable outer bladder disposed adjacent to the outer surface of the inner cuff, the outer bladder having 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 in the inner cuff and a second pressure in the outer bladder, the first pressure of the inner cuff being less than the second pressure of the outer bladder.

[0012] In one or more of the above aspects, a secretion removal system for the airway tube includes a secretion collection receptacle disposed at the proximal end of the cuff assembly, the cuff assembly being disposed around the outer periphery of the airway tube. The system further includes a suction channel including a distal end proximate to the secretion collection receptacle and a proximal end provided at the proximal end of the airway tube, the proximal end of the suction channel being in fluid communication with a vacuum.

[0013] In one or more of the above aspects, the inner cuff is configured to expand within a first pressure range, the outer bladder is configured to expand within a second pressure range, and the first pressure range is less than the second pressure range. For example, the inner cuff is configured to expand to a pressure within the range of 10 cmH2O to 20 cmH2O, and the outer bladder is configured to expand to a pressure within the range of 50 cmH2O to 150 cmH2O.

[0014] In one or more of the above aspects, the outer surface of the outer bladder is configured to have a relatively smooth surface when inflated.

[0015] In one or more of the above aspects, a first inflation lumen is coupled inside the inner cuff, and a second inflation lumen is coupled inside the outer bladder.

[0016] In one or more of the above aspects, the inner cuff includes a relatively elastic material, and this relatively elastic material includes one or more of silicone, latex, polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0017] In one or more of the above aspects, the outer bladder includes a relatively non-elastic material, and this relatively non-elastic material includes one or more of polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0018] In one or more of the above aspects, the pressure regulator is configured to adjust a first pressure within the inner cuff using a first pneumatic path and to adjust a second pressure within the outer bladder using a different second pneumatic path, and the first pressure within the inner cuff is less than the second pressure within the outer bladder.

[0019] In one or more of the above aspects, a pressure sensor device is disposed between the inner cuff and the outer bladder, and this pressure sensor device measures the pressure between the cuffs.

[0020] In one or more of the above aspects, the pressure regulator is configured to at least adjust the first pressure within the inner cuff and the second pressure within the outer bladder in response to the pressure between the cuffs.

[0021] In one or more of the above aspects, a first lumen extends from the airway tube to the inner cuff, the first lumen is fluidly coupled to the inner cuff, a second lumen extends from the airway tube to the outer bladder, and the second lumen is fluidly coupled to the outer bladder.

[0022] In one or more of the above aspects, the pressure adjustment system uses a first lumen to add or remove air from the inner cuff to maintain a first pressure within the inner cuff and a second lumen to add or remove air from the outer bladder to maintain a second pressure within the outer bladder, and the first pressure is less than the second pressure.

[0023] 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 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 configured to add or remove air from the outer bladder.

[0024] In one or more of the above aspects, a pressure sensor device is disposed between the inner cuff and the outer bladder, the pressure sensor device measures the pressure between the cuffs, and the pressure adjustment system is configured to adjust the first pressure of the inner cuff and the second pressure of the outer bladder in response to the pressure between the cuffs.

[0025] In one or more of the above aspects, the secretion removal receptacle includes an outer wall of the cuff assembly that extends proximally from the proximal surface of the cuff assembly to form a groove for collecting secretions, the groove is located at least posteriorly of the airway tube, and a proximal inclined surface that inclines inwardly from the outer wall toward the upper surface of the cuff assembly forms the groove for collecting secretions.

[0026] In one or more of the above aspects, the secretion collection receptacle includes an outer wall that extends from the proximal end of the outer bladder and forms a groove with the proximal surface of the inner cuff and / or the proximal surface of the outer bladder.

[0027] In one or more of the above aspects, the suction channel includes a catheter. The catheter guide is configured to hold the catheter and is located on the front side of the outer surface at the proximal end of the airway tube. The catheter guide wraps around to a position on the rear side of the outer surface at the distal end of the airway tube.

[0028] In one or more of the above aspects, the suction channel is located inside the airway tube and extends to the rear portion of the inner wall of the airway tube. The airway tube forms an opening proximate to the secretion collection receptacle, and a hollow channel is in fluid communication with the secretion collection receptacle through the opening for the discharge of secretions. BRIEF DESCRIPTION OF THE DRAWINGS

[0029]

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[0030] As used herein, the terms "exemplary" or "embodiment" are used in the sense of "an example, instance, or illustration that serves as an example." Embodiments or aspects described herein as "exemplary" or "embodiments" are not necessarily to be construed as being more preferred or advantageous than other aspects of the present disclosure. Similarly, the term "aspect" does not require that all aspects of the present disclosure include the features, advantages, or modes of operation being considered.

[0031] Embodiments will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the aspects described herein. However, as will be apparent to those skilled in the art, those aspects and other aspects may be practiced without some or all of these specific details. Additionally, well-known steps in a process method may be omitted from the flow diagrams presented herein in order not to obscure the aspects of the present disclosure. Similarly, well-known components in a device may be omitted from the drawings and their description presented herein in order not to obscure the aspects of the present disclosure.

[0032] SUMMARY This specification describes a cuff assembly, a pressure adjustment system, and a subglottic secretion removal system for achieving ventilation and protection of intubated patients. The cuff assembly includes a toroidal outer bladder and an inner cuff. The inner cuff is disposed adjacent to the outer surface of the airway tube, and the outer bladder is disposed adjacent to the outer surface of the inner cuff. The outer bladder includes a low-elasticity material and operates as a low-volume high-pressure (LVHP) structure, with fewer wrinkles upon inflation and more optimized tracheal sealing. The inner cuff includes a more elastic material or a super-elastic material and operates as a high-volume low-pressure (HVLP) structure.

[0033] 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 individually controlled. A pressure sensor between the inner cuff and the outer bladder is disposed to effectively measure the tracheal wall pressure. The pressure adjustment system receives inputs from the pressure sensor between the cuffs 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 the inputs from the pressure sensors.

[0034] The secretion removal system includes a secretion receptacle and a suction catheter. In one embodiment, the secretion receptacle is formed by the proximal portion of the cuff assembly. For example, the outer bladder extends further proximally than the proximal end of the inner cuff (outer bladder extension). The outer bladder extension is configured such that its outer peripheral wall further extends or the outer peripheral wall is longer than its inner wall. Thus, the proximal surface of the outer bladder extension slopes distally from the outer peripheral surface of the outer wall towards the junction of the inner cuff and the outer bladder. The suction catheter discharges the secretion accumulated in the receptacle. A guide or conduit for the suction catheter extends from the secretion collection receptacle to the proximal end of the airway tube. At the proximal end of the airway tube, the catheter guide is positioned on the front side of the airway tube so as to fit between the vocal cords of the intubated patient. The catheter guide extends circumferentially to the rear side of the airway tube at the distal end of the airway tube to position the catheter near the secretion receptacle.

[0035] Alternatively, the suction catheter and the suction catheter guide are replaced by a channel provided in the rear wall of the endotracheal tube. The suction channel is circular or elliptical and has a cross-sectional area of 10 to 20 square millimeters. The proximal channel opening located near the proximal end of the endotracheal tube is in fluid communication with the suction catheter and can be connected to a vacuum. The distal opening of the suction channel is in fluid communication with the secretion collection cavity.

[0036] Embodiments of the cuff assembly Next, the cuff assembly will be described in more detail. Different from the cuffs of the endotracheal tubes known so far, in the present embodiment described in this specification, a novel cuff system with at least two separately controlled inflatable bladders is introduced.

[0037] The high-pressure outer bladder is attached to the outer surface of the endotracheal tube by the inner cuff. The inner cuff is coupled to the distal end of the endotracheal tube. The second outer bladder is coupled to the outer surface of the inner cuff. The inner cuff is a low-pressure inflatable cuff configured to function in a low-pressure range of 10 cmH2O to 20 cmH2O. In contrast, the outer inflatable bladder is configured to inflate in a high-pressure range of 50 cmH2O to 150 cmH2O. Thus, the inner cuff operates in a pressure range lower than that of the outer bladder.

[0038] Figure 1 shows one embodiment of a cuff assembly 100 implemented with an endotracheal tube 102. The endotracheal tube 102 is a conduit configured to be placed intratracheally from the oral cavity to supply air rich in oxygen and / or other gases and medications to the patient's lungs. The endotracheal tube 102 can be composed of a soft polyvinyl chloride (PVC) material. Although the endotracheal tube 102 is described herein, the cuff assembly 100 can be implemented in combination with any suitable medical device, including but not limited to, for example, a tracheostomy tube or other airway tubes, catheters, stents, and / or feeding tubes.

[0039] Typically, the cuff assembly 100 is positioned towards the distal end of the endotracheal tube 102 by means of an adhesive or other method. The cuff assembly 100 includes an inner cuff 104 of a first donut or torus shape, which is disposed adjacent to the endotracheal tube 102. The inner cuff 104 is inflatable and configured to expand radially from the endotracheal tube 102. A second torus-shaped outer bladder 106 is disposed adjacent to the periphery of the inner cuff 104, and at least a portion of the inner cuff 104 is located between the outer bladder 106 and the endotracheal tube 102. The outer bladder 106 is configured to expand radially from the inner cuff 104, such that the outer surface of the outer bladder 106 comes into contact with the tracheal wall. In one embodiment, as shown in FIG. 1, the upper surface 114 of the outer bladder 106 extends to cover the upper surface of the inner cuff 104 and is sealed at the joint 116 with the inner cuff 104 and / or the endotracheal tube 102. The band 118 can fix and / or attach the cuff assembly 100 to the endotracheal tube 102.

[0040] The inner cuff 104 is composed of a relatively elastic material, while the outer bladder 106 is composed of a relatively non-elastic material. For example, the material of the outer bladder is less elastic than the material of the inner cuff 104. For example, the relatively elastic material of the inner cuff can include one or more of silicone, latex, polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU). The relatively non-elastic material of the outer bladder 106 can include one or more of polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0041] The outer bladder 106 and the inner cuff 104 are configured to expand to different pressures and maintain those pressures. The relatively more elastic inner cuff is configured to operate in an inflated state within a lower pressure range, for example, a pressure range of 10 cmH2O to 20 cmH2O. In contrast, the less elastic or relatively non-elastic outer bladder is configured to operate in an inflated state within a higher pressure range of 50 cmH2O to 150 cmH2O.

[0042] In use, for example, when inserted into the trachea and pressurized to an inflated state, the first inner cuff 104 operates as an HVLP type cuff while the second outer bladder 106 operates as an LVHP type cuff. The more compliant inner cuff 104 can mitigate the pressure ("tracheal pressure") applied to the tracheal wall by the outer bladder 106 to which a higher pressure is applied. In other words, the lower pressure and more elastic inner cuff 104 is configured to absorb the excessive pressure (which might otherwise act on the tracheal wall by the outer bladder 106 if not absorbed by the inner cuff). For example, since the inner cuff 104 is more compliant and elastic, the cuff assembly 100 applies a lower (e.g., lower than the outer bladder pressure) total pressure / force to the tracheal wall. The force of the inner cuff 104 acts radially with respect to the outer bladder 106 and ultimately becomes the force applied to the trachea as the tracheal pressure. Thus, the radial force generated by the inner cuff 104 and acting on the outer bladder 106 becomes the tracheal pressure. For example, when the cuff internal pressure of the outer bladder is greater than that of the inner cuff and the outer bladder expands such that its outer surface contacts the trachea, the cuff internal pressure of the inner cuff becomes the same as the tracheal pressure.

[0043] Furthermore, the inflated outer bladder 106 forms a relatively smooth surface with fewer wrinkles, for example, compared to an LVHP cuff. By reducing the wrinkles, the risk of leakage is decreased and a more uniform tracheal seal is formed.

[0044] In this way, the cuff assembly 100 utilizes an innovative system for adjusting tracheal pressure, thereby reducing tracheal complications. By incorporating the characteristics of HVLP and LVHP cuffs into one system, the cuff system 100 takes advantage of the benefits seen in both types of cuffs, namely, excellent tracheal sealing against the trachea and higher safety. The cuff system 100 has the advantages of excellent sealing against the tracheal wall and reduction of damage to the trachea. Therefore, the cuff assembly 100 helps protect the lungs from contamination by oral gastric contents and blood without causing excessive damage to the tracheal wall.

[0045] In one embodiment, the cuff assembly 100 can also include a secretion collection system implemented to collect and remove aspirate or other fluids that can accumulate around the proximal end of the cuff assembly 100. The secretion collection system includes a secretion collection receptacle 108 disposed at the proximal end of the cuff system 100. The suction catheter 110 is configured to empty the receptacle 108 and is disposed within or adjacent to the receptacle 108 behind the endotracheal tube 102. The catheter guide 112 can surround the catheter 110 on the outer surface of the tube 102.

[0046] Figure 2 shows the cuff system 100 along with a cross-section of the outer bladder 106. In this embodiment, the outer bladder 106 is a self - contained structure and has, for example, a wall 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 disposed adjacent to the outer surface 214 of the inner cuff 104 and is attached to the outer surface 214 of the cuff 104 using, for example, one or more of an adhesive, heat, or other means.

[0047] The outer bladder 106 is configured to expand and contract via a first lumen 218 that communicates with the outer bladder 106 through an opening 222 formed in the lumen. The lumen 218 may be disposed inside or outside of, or attached to, the endotracheal tube 102 and may extend to the proximal end of the endotracheal tube 102.

[0048] 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 receive the endotracheal tube 102. The proximal band 212a is located further away from the distal end of the endotracheal tube 102, and the distal band 212b is located closer to the distal end of the endotracheal tube 102. The bands 212a, 212b assist in coupling the inner cuff 104 to the endotracheal tube 102 and may be further attached to the endotracheal tube 102 using an adhesive, heat, or other means.

[0049] The inner cuff 104 is configured to expand and contract 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 disposed inside or outside of, or attached to, the endotracheal tube 102 and may extend to the proximal end of the endotracheal tube 102.

[0050] The distal end 224 of the endotracheal tube 102 forms a window 226 and / or an opening 228 for passing oxygen-rich air into the trachea. Although the endotracheal tube 102 has been described here, the cuff assembly 100 provided herein is not limited to other types of airway tubes, catheters, stents, and / or feeding tubes, but can be used in combination with any suitable medical device including them.

[0051] Figures 3A and 3B show cross-sectional views of one embodiment of the cuff system 100. Figure 3A shows a top cross-sectional view of the cuff system 100, and Figure 3B shows a side cross-sectional view of the cuff system 100. As shown in Figure 3A, the outer bladder 106 is an inflatable toroidal or donut-shaped self-contained structure having an outer surface 204 and an inner surface 210. Similarly, the inner cuff 104 is an inflatable toroidal or donut-shaped self-contained structure having an outer surface 214 and an inner surface 302.

[0052] The inner surface 210 of the outer bladder 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. Thus, at least a portion of the inner cuff 104 is positioned between the outer bladder 106 and the endotracheal tube 102.

[0053] In one embodiment shown in Figure 1, the proximal surface 306 of the outer bladder 106 extends up to the inner cuff 104 and is sealed at the upper surface 318 of the inner cuff 104 and / or at the junction with the endotracheal tube 102. Thereby, the proximal surface 306 of the bladder 106 prevents leakage between the inner cuff 104 and the outer bladder 106. Alternatively or additionally, the outer surface 214 of the inner cuff 104 can be attached to form a seal against leakage, or pressed against the inner surface 210 of the outer bladder 106, thereby, for example, preventing secretions and other substances from leaking from the junction. For example, the inner cuff 104 and the outer bladder 106 can be attached with an adhesive, or using a heating process or a combination thereof.

[0054] Further, to prevent leakage, the inner surface 302 of the inner cuff 104 is sealed to, attached to, or pressed against the outer surface 304 of the endotracheal tube 102. For example, the inner cuff 104 and the endotracheal tube 102 are attached by an adhesive, using a heating process, or a combination thereof. By such sealing or attachment, leakage of secretions between the endotracheal tube 102 and the inner cuff 104 is prevented.

[0055] In another embodiment shown in FIGS. 2 and 3B of this figure, the secretion collection receptacle 108 can be formed by using the outer surface 204 of the outer bladder 106 to form the wall 316. For example, a portion of the outer surface 204 of the outer bladder 106, such as a portion proximal to the cuff assembly 100, extends upward from the proximal surface 318 of the inner cuff 104. The proximal surface 306 of the outer bladder 106 slopes inwardly from the wall 316 toward the proximal upper surface 318 of the inner cuff 104 to form a valley or groove around at least a portion of the outer periphery of the endotracheal tube 102, for example, at least on the posterior side of the endotracheal tube 102. The groove or valley of this secretion collection receptacle 108 collects secretions or particulates that can be removed using a suction catheter 110, as further described herein. In another embodiment shown in FIGS. 2 and 11B, the wall 316 of the outer bladder 106 is not angled or sloped. The outer surface 204 of the outer bladder forms a flat or relatively flat wall 316 that extends in a proximal direction and at a relatively vertical angle with respect to the upper surface 318 of the inner cuff 104.

[0056] Figures 3C and 3D show another embodiment of the cuff system 100 in which the inner cuff 104 is at least partially formed 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 with an airtight seal. For example, the outer surface 214 of the inner cuff can form bands 212a, 212b that surround the endotracheal tube 102 to form an airtight seal with respect to the endotracheal tube 102.

[0057] One or more features of the various embodiments of FIGS. 3A-3D can be used in any of the embodiments shown herein.

[0058] Figure 4 shows a cross-sectional view of the cuff assembly 100 implemented with the endotracheal tube 102. In one embodiment, 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 disposed inside or outside the endotracheal tube 102, and are, 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 disposed on the outer surface 304 of the endotracheal tube 102.

[0059] In one embodiment, the catheter guide 112 is disposed at the rear side 408 of the endotracheal tube 102, proximate to the secretion collection receptacle 108. Thereafter, the catheter guide 112 extends circumferentially around the endotracheal tube 102 and is located at the front side 406 of the endotracheal tube 102 at the proximal end of the endotracheal tube 102. The suction tube 110 is located within the catheter guide 112 and is replaced if blockages or other malfunctions occur.

[0060] In one embodiment, the inner cuff 104 and the outer bladder 106 have substantially equal lengths L CAhas. For example, the length L of the cuff assembly CA is about 30 millimeters (mm). In other embodiments, one or more of the inner cuff 104 or the outer bladder 106 are longer or shorter than the other length.

[0061] Furthermore, in one embodiment, the width W of the outer bladder OB and the width W of the inner cuff IC are approximately equal. For example, the width W of the outer bladder OB and the width W of the inner cuff IC are about 6 mm. In other embodiments, the width W of the outer bladder OB or the width W of the inner cuff IC may be different from each other. For example, the inner cuff 104 may 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.

[0062] 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 may be implemented with other endotracheal tubes having alternative dimensions, or with other medical devices having various sizes and dimensions. Furthermore, the exemplary sizes and dimensions of the cuff assembly 100 described herein can be changed according to the medical device and the implementation.

[0063] Figures 5A and 5B show in more detail an exemplary embodiment of the distal end 224 of the endotracheal tube 102. The distal end 224 is disposed at the distal end 404 of the endotracheal tube 102 at the distal end of the cuff assembly 100. The distal end 224 can form an opening 228 with an inclined wall. For example, the wall can form an angle of about 45 degrees. Additionally or alternatively, a window 226 is formed on the side surface of the distal end 224. Thus, the distal end 224 can include two openings 226, 228 for passing oxygen-rich air into the trachea.

[0064] The cuff assembly 100 improves the sealing against the tracheal wall because the outer bladder 106 at a higher pressure forms a relatively smooth surface with fewer wrinkles and creases than, for example, an HVLP cuff. Further, the inner cuff 104 at a lower pressure can reduce the total pressure that the cuff assembly 100 exerts on the tracheal wall, such that it is equal to or lower than the pressure of a typical HVLP cuff, while improving the sealing against the tracheal wall. This results in a lower total pressure on the tracheal mucosa and a reduced risk of ischemic injury. Also, the cuff assembly 100 is less bulky than an HVLP cuff, facilitating patient intubation.

[0065] Embodiments of the pressure adjustment system The advantages and risks of an endotracheal tube depend more on maintaining a preset pressure range in the cuff assembly than on the tube itself. For example, overinflating the cuff assembly can cause ischemic injury and laryngeal nerve injury, which can in turn cause tracheal mucosal injury. This injury is due to a certain pressure applied by the cuff that impedes blood flow to the tracheal mucosa. This reduction in blood flow can lead to tissue necrosis. Further, damage can also occur due to repeated abrasion caused by the movement of the cuff against the tracheal wall. If the cuff is underinflated and the tracheal seal is inadequate, the patient may not be able to intake sufficient oxygen. Further, the patient is at a higher risk of pneumonia due to aspiration of oropharyngeal and gastric contents. Therefore, maintaining the pressure of the cuff assembly 100 of the endotracheal tube 102 is an important element of patient care from the perspective of reducing tracheal injury and preventing ventilator-associated pneumonia (VAP).

[0066] Currently, several types of automatic cuff pressure regulators are available. Those current devices monitor the intracuff pressure within a single cuff. However, upon closer examination, it can be seen that this approach has significant drawbacks. The intracuff pressure does not reflect the exact pressure acting on the tracheal wall. Ultimately, it is the tracheal wall pressure that determines both the risks and advantages of the cuff. Therefore, an improved system and method for monitoring and adjusting cuff pressure are needed.

[0067] Figure 6 shows an embodiment of the inter-cuff pressure sensor device 602 in the cuff assembly 100. In this embodiment, the pressure adjustment system utilizes the inter-cuff pressure sensor device 602 located at least between the inner cuff 104 and the outer bladder 106 to monitor the tracheal pressure. 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.

[0068] The force of the inner cuff 104 acts radially on the outer bladder 106, and as a result, it becomes the force that ultimately acts on the tracheal wall as the tracheal pressure. That is, the radial force generated by the inner cuff 104 and acting on the outer bladder 106 becomes the resulting tracheal pressure. For example, when the cuff internal pressure of the outer bladder is greater than that of the inner cuff 104 and the outer bladder 106 is inflated and its outer surface 204 is in contact with the tracheal wall, the radial force of the inner cuff 104 on the outer bladder 106 becomes the pressure on the tracheal wall. Since the inter-cuff pressure sensor device 602 is disposed between the inner cuff 104 and the outer bladder 106, it measures the radial force of the inner cuff 104 on the outer bladder 106. In this way, the pressure sensor 602 measures the tracheal pressure, for example, the pressure exerted by the cuff assembly 102 on the tracheal wall.

[0069] In one embodiment, the inter-cuff pressure sensor device 602 is electrically communicably 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 cuff internal pressure sensor device 602 transmits the pressure measurement value to the pressure adjustment system via 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 wirelessly transmit the pressure measurement value to the pressure adjustment system using the wireless transmitter.

[0070] An additional pressure sensor device can also be disposed within the cuff assembly. For example, a pressure sensor device can be disposed within the inner cuff 104 to measure the intracuff pressure within the inner cuff 104. Further, a pressure sensor device can be disposed within the outer bladder 106 to measure the pressure therein. Also, another pressure sensor device can be disposed on the outer surface of the bladder 106 to measure the tracheal pressure. Additionally, an additional pressure sensor device can be disposed within the endotracheal tube 102 or at the distal end 224 of the endotracheal tube 102 to measure the pressure of the oxygen-rich air delivered to the patient.

[0071] Figure 7 shows an exemplary embodiment of an endotracheal tube 102 having a cuff assembly 100. The lead guide 606 and the 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 connected to a pressure regulation system for transmission of the intercuff pressure measurement value and / or for power supply.

[0072] The first pilot balloon 704 is attached to the distal end of the first lumen 218, and the first lumen 218 is fluidly coupled to the outer bladder 106. The first pilot balloon 704 can expand with the outer bladder 106 and function as an indicator of the pressure within the outer bladder 106 and whether the outer bladder 106 is expanded.

[0073] Similarly, the second pilot balloon 706 has its lower end attached to the second lumen 220, and the second lumen 220 is fluidly coupled to the inner cuff. The second pilot balloon 706 can expand with the inner cuff 104 and function as an indicator of the pressure within the inner cuff 104 and whether the inner cuff 104 is expanded.

[0074] The proximal ends of the first and second pilot balloons 704, 706 include first and second adapters 708, 710. The first and second adapters 708, 710 are coupled to an air pump within a pneumatic device, as described below.

[0075] FIG. 8 shows a schematic block diagram of an exemplary embodiment of a pressure regulator and control system (“regulation system”) 800 for a cuff assembly 100. The regulation system 800 is in fluid communication with the cuff assembly 100, inflates the cuff assembly, and regulates the pressure within the cuff assembly, for example when the endotracheal tube 102 is inserted into a patient's trachea. The pressures of the inner cuff 104 and the outer cuff bladder 106 of the cuff assembly 100 are monitored and controlled separately.

[0076] The adjustment 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 cause the adjustment system 800 to perform one or more of the functions described herein when executed by the processor device 808 or other components of the adjustment system 800. 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 operates signals (analog and / or digital) based on hardcoding and / or operating instructions of the circuit. The memory device 810 includes a non-transitory memory device, which may be an internal memory or an external memory, and may be a single memory device or multiple memory devices. The memory device 810 can be a read-only memory, a random access memory, a volatile memory, a non-volatile memory, a static memory, a dynamic memory, a flash memory, a cache memory, and / or any non-transitory memory device that stores digital information.

[0077] The pressure controller 806 may be provided together with the pneumatic system 820 within the same physical device, or may be provided separately in another device or housing. The pressure controller 806 further includes a user interface 812. The user interface 812 generates user input / output (I / O) and includes one or more of a display, a keyboard, a touch screen, a mouse, a touch pad, a gauge, a switch, or other I / O devices.

[0078] During use, in response to user input received by the user interface 812, a desired predetermined pressure setting for the cuff assembly 100 is determined by the pressure controller 806. Alternatively, a default pressure setting can be implemented, for example, when there is no user input.

[0079] Different pressure settings can be set for the inner cuff 104 and the outer bladder 106. The pressure settings can be a preset pressure or pressure range, for example, usually within a range of plus or minus 2 cmH2O. For example, the pressure setting for the inner cuff can be a pressure (plus or minus 2 cmH2O) within the range of 10 cmH2O to 20 cmH2O. In contrast, the pressure setting for the outer inflatable bladder can be a pressure (plus or minus 2 cmH2O) within the range of 50 cmH2O to 150 cmH2O. Thus, the inner cuff 104 operates within a pressure range that is smaller than the operating pressure range of the outer bladder 106. Further, the pressure controller 806 determines the frequency of measuring and adjusting the pressure of the cuff assembly 100, for example, based on either user input or a default setting.

[0080] The pneumatic system 820 includes a first pneumatic path for the outer bladder 106, which is fluidly coupled to the outer bladder 106 via, for example, the output port 826a, the adapter 708, the pilot balloon 704, and the lumen 218, and includes, for example, a first air pump 822a and a discharge valve 824a. The pneumatic system 820 further includes a separate second pneumatic path for the inner cuff 104, which includes a second air pump 822b and a discharge valve 824b that are fluidly coupled to the inner cuff 104 via, for example, the output port 826b, the adapter 710, the pilot balloon 706, and the lumen 220. Although two air pumps 822a, 822b are described here, it is also possible for a single air pump to supply pressurized air to the inner cuff 104 and the outer bladder 106 using, for example, valves or switches between the two fluid paths.

[0081] Thus, the pneumatic system 820 includes separate pneumatic paths that fluidly increase and decrease the pressures of the air cuff 104 and the outer bladder 106 independently and separately. The pneumatic paths can include individual air pumps 822a, 822b, or can alternatively include a single air pump with a valve that switches between the pneumatic path of the outer bladder 106 and the pneumatic path of the inner cuff 104.

[0082] During operation, the pressure controller 806 receives pressure measurements from one or more pressure sensor devices and adjusts the pressure of the cuff assembly 100. For example, the inter-cuff pressure sensor device 602 is disposed between the inner cuff 104 and the outer bladder 106 and measures the radial force of the inner cuff 104 relative to the outer bladder 106. Another inner cuff pressure sensor device 802 can be disposed within the inner cuff 104 to measure the pressure within the cuff. Additionally, an outer bladder pressure sensor device 804 can be disposed to measure the pressure within the outer bladder 106. Further, another outer cuff assembly pressure sensor device 814 can be disposed on the outer surface of the outer bladder 106 to measure the tracheal wall pressure. Additionally, additional pressure sensor devices can be implemented. The pressure sensor devices generate pressure measurements and communicate them to the pressure controller 806, for example, via a wired lead and / or a wireless transmitter.

[0083] Adjustment system 800 includes a pressure feedback loop, and pressure controller 806 controls pneumatic system 820 to adjust the pressure of both inner cuff 104 and outer bladder 106 in response to the pressure measurement value. The pressures of inner cuff 104 and outer bladder 106 are monitored and controlled separately. Pressure controller 806 sends a signal to pneumatic system 820 to add or release air to / from outer bladder 106 and / or inner cuff 104. For example, to adjust the pressure in outer bladder 106, pressure controller 806 sends a signal to air pump 822a to add air to outer bladder 106 or sends a signal to release valve 824a to release air from outer bladder 106. In another example, to adjust the pressure of the inner cuff, pressure controller 806 sends a signal to air pump 822b to add air to inner cuff 104 or sends a signal to release valve 824b to release air from inner cuff 104.

[0084] Adjustment system 800 monitors the pressure measurement value and automatically adjusts the pressure of outer bladder 106 first and then the pressure of inner cuff 104 to achieve a predetermined pressure setting preselected, for example, by an operator or by default. Pressure controller 806 can continuously monitor and adjust the pressure of cuff assembly 100 or can monitor and adjust the pressure at preset intervals. Adjustment system 800 can further include visual and / or audible alarms if a non-safe pressure measurement value occurs.

[0085] Figure 9 shows a flowchart of one embodiment of one or more methods 900 for monitoring and controlling the pressure of the cuff assembly 100, for example, by an adjustment system 800. In step 902, one or more pressure measurements related to the tracheal wall pressure are obtained by the adjustment system 800 from one or more pressure sensor devices. Using these pressure measurements, in step 904, the adjustment system 800 determines whether the tracheal pressure, for example, the pressure applied to the tracheal wall by the cuff assembly 100, is within a preset pressure range. The pressure measurements can be obtained from the cuff - to - cuff pressure sensor device 602 between the inner cuff 104 and the outer bladder 106 and / or from one or more pressure sensors 814 disposed on the outer surface of the outer bladder 106. When the tracheal pressure exceeds the preset pressure range, the system 800, in step 906, reduces the pressure at least within the inner cuff 104. For example, the adjustment system 800 can control the release valve 824b to release air from the inner cuff 104. Since the blood flow of the tracheal mucosa can be impaired when a pressure exceeding 30 cmH2O (22 mmHg) is applied, the adjustment system 800 can reduce the pressure at least within the inner cuff 104 when the measured tracheal pressure exceeds 30 cmH2O (22 mmHg).

[0086] When the tracheal pressure is below the preset pressure range, in step 906, the adjustment system 800 increases the pressure at least within the inner cuff 104. For example, the adjustment system 800 can control the air pump 822b to pump air into the inner cuff 104. Additionally, the pressure of the outer bladder 106 can also be adjusted. These steps can be performed at preset intervals or continuously.

[0087] In step 908, the adjustment system 800 obtains one or more pressure measurement values related to the outer bladder pressure from one or more pressure sensor devices. In step 910, the adjustment system 800 uses those pressure measurement values to determine whether the pressure of the outer bladder 106 is within a preset pressure range. For example, the pressure measurement values can be obtained from a pressure sensor device 804 disposed within the outer bladder 106 or in the pilot balloon 704 for the outer bladder 106. If the outer bladder pressure is below or above the preset pressure range, the adjustment system 800 increases or decreases the pressure within the outer bladder 106 in step 912. For example, if the pressure is below the preset pressure range, the adjustment system 800 controls the air pump 822a to send air into the outer bladder 106, while if the pressure is above the preset pressure range, it can control the discharge valve 824a to discharge air from the outer bladder 106. The outer bladder 106 can have a preset pressure range of 50 cmH2O to 150 cmH2O.

[0088] In step 914, the adjustment system 800 obtains one or more pressure measurement values related to the inner cuff pressure from one or more pressure sensor devices. In step 916, the adjustment system 800 uses those pressure measurement values to determine whether the pressure of the inner cuff 104 is within a preset pressure range. For example, the pressure measurement values can be obtained from a pressure sensor device 802 disposed within the inner cuff 104 or in the pilot balloon 706 for the inner cuff 104. If the inner cuff pressure is below or above the preset pressure range, the adjustment system 800 increases or decreases the pressure within the inner cuff 104 in step 918. For example, the adjustment system 800 controls the air pump 822b to send air into the inner cuff 104 when the pressure is below the preset pressure range, while it can control the release valve 824b to release air from the inner cuff 104 when the pressure is above the preset pressure range. The inner cuff is a low-pressure inflatable cuff and can have a preset pressure range of 10 cmH2O to 20 cmH2O.

[0089] Thus, the pressures of the inner cuff 104 and the outer cuff bladder 106 of the cuff assembly 100 are controlled separately using separate pneumatic paths, such as 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 elastic inner cuff. In this way, the pressure controller 802 can independently adjust the pressure of the inner cuff 104 or the outer bladder 106 to adjust the tracheal pressure.

[0090] The intracuff pressure sensor 602 between the inner cuff 104 and the outer bladder 106 provides a measurement value of the tracheal pressure. The pressure controller 802 can independently adjust the pressure of the inner cuff 104 and / or the outer bladder 106 to adjust the tracheal pressure, for example, when the tracheal pressure exceeds or is below a non-safe threshold.

[0091] In this way, the cuff assembly 100 and the adjustment system 800 help reduce aspiration and lung infections by maintaining good sealing with the tracheal wall without overly damaging the tracheal wall. This system improves the sealing of the airway and minimizes damage to the airway.

[0092] Embodiments of the Secretion Removal System Ventilated (MV) patients are placed in a physiologically altered environment. For example, their ability to remove oral and nasal secretions is reduced, tracheobronchial mucociliary clearance is decreased, secretions accumulating in the lungs and bronchi increase, the cough reflex is reduced, and the likelihood of gastric acid reflux is increased. Due to the combined effects of all these factors, ventilated patients are prone to ventilator-associated pneumonia (VAP), a lung infection that usually develops within 48 hours after ventilation.

[0093] The accumulation of secretions above the endotracheal tube (ETT) cuff (including, but not limited to, the cuff assembly 100 described herein) in MV patients is a normal physiological phenomenon. The sources of secretions are the oral cavity, paranasal sinuses, and stomach ("oropharyngeal secretions"). Under normal conditions, the oral cavity and paranasal sinuses are known to produce up to 3 liters of secretions per day. This does not include the potential for a significant amount of gastric juice reflux. Healthy individuals can remove and / or process secretions, but ventilated patients cannot. Instead, in ventilated patients, tracheal secretions accumulate above the ETT cuff or leak through the ETT cuff into the trachea and lungs.

[0094] The concern regarding the accumulation of secretions above the ETT cuff is that the secretions contain microorganisms, including bacteria and fungi. Since the secretions are highly contaminated, it is necessary to keep them away from the sterile organs of the human body. The lungs are one of the sterile organs. Therefore, it is essential for the treating physician to prevent the leakage of secretions into the patient's lungs.

[0095] The ETT cuff can be a powerful mechanism for preventing aspiration. When inflated, the ETT cuff circumferentially contacts the tracheal wall and achieves a complete sealing state. Unfortunately, as described above, it is known that for cuffs that are too large, wrinkles and folds are formed, making it impossible to provide efficient sealing.

[0096] One strategy for combating VAP is to improve the occlusion function of the ETT cuff, that is, to improve the sealing ability of the ETT cuff, as described herein with respect to the cuff assembly 100 for example, thereby reducing the secretions leaking into the lungs. This strategy is useful, but if it is allowed for secretions to accumulate on the ETT cuff, ultimately the pressure of the secretions will likely cause the secretions to leak into the lungs. Therefore, in addition to effective tracheal occlusion, an effective means for removing secretions is also necessary.

[0097] Current systems for removing secretions include a suction tube proximate to the proximal end of the ETT cuff. However, the configuration of the opening of the suction tube is known to cause direct damage to the tracheal mucosa and suction trauma. The opening of the suction tube is configured to be easily blocked by the cuff wall. Furthermore, the suction tube is easily blocked due to its small size. If the suction tube is too large, the profile of the ETT may increase, making the intubation process more difficult. Additionally, when the suction tube is incorporated into the ETT, if the suction tube becomes blocked, it is necessary to replace the entire ETT and the ETT cuff. Therefore, there is a need to improve the secretion removal system.

[0098] Figure 10A shows one embodiment of a secretion removal system 1000 that provides an improved system and method for effectively removing secretions from an ETT cuff 1002. The secretion removal system 1000 includes a secretion collection receptacle 108, a suction catheter 110, and a catheter guide 112. The secretion removal system 1000 is implemented with an endotracheal tube 102, but can also be implemented with other types of airway tubes or other medical devices such as stents. The ETT cuff 1002 can include the cuff assembly 100 described herein, or can include other types of cuffs such as HVLP cuffs or LVHP cuffs.

[0099] The secretion collection receptacle 108 is disposed posterior to the endotracheal tube 102 and proximal to or on the proximal side of the ETT cuff 1002. When the patient is in the prone position typical of an intubated patient, secretions tend to accumulate on the posterior side of the trachea. Since the receptacle 108 is disposed on the posterior side of the ETT 102 and the ETT cuff 1002, it is more likely to collect more of the accumulated secretions. In other embodiments, the receptacle 108 can surround the ETT 102. In other embodiments, the receptacle 108 surrounds only a portion of the outer periphery of the posterior side 408 of the endotracheal tube (ETT) 102, for example, only 180 degrees of the outer periphery.

[0100] The catheter 110 is preferably a thin-walled, non-foldable, flexible hollow channel or tube. The catheter 110 is configured to empty the receptacle 108, and thus at least the tip 1004 of the catheter 110 is disposed within or adjacent to the receptacle 108. The tip 1004 of the catheter is disposed on the posterior side of the endotracheal tube 102 and the ETT cuff 1002. The catheter tip 1004 is in a position suitable for aspirating and removing the accumulated secretions of a prone intubated patient that tend to accumulate on the posterior side of the trachea and in the receptacle 108.

[0101] The catheter guide 112 surrounds the aspiration catheter 110 to protect the catheter 110. The pre-formed channel of the catheter guide 112 is disposed outside 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 the ETT 102 to the rear side 408 of the distal end 404 of the ETT 102 over a semi-circle.

[0102] In a prone intubated patient, there is an opening in front of the trachea between the vocal cords. Since the catheter guide 112 is positioned in front of the ETT 102 at the proximal end 402, the catheter guide 112 can fit within this opening between the vocal cords without applying excessive pressure to the trachea. By being thus disposed between the vocal cords, the catheter guide 112 and the aspiration catheter 110 can have their diameters increased. A larger diameter of the catheter 110 may 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.

[0103] At the distal end 404 of the ETT 102, the catheter guide 112 and the catheter 110 are positioned around the ETT 102 for about half a turn and at the rear side 408 of the ETT 102 to improve the collection of secretions that tend to accumulate behind the trachea and the ETT cuff 1002. The catheter guide 112 can extend into or near the collection receptacle 108. The tip 1004 of the catheter extends into or near the collection receptacle 108. In one example, the catheter 110 and the tip 1004 are composed of one or more of semi-rigid materials, such as polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU). The size of the catheter 110 is 7 to 12 French, for example, with an outer circumference of 7.33 mm to 12.57 mm. In one embodiment, the tip 1004 of the catheter includes at least two openings (for example, one on each side of the tip 1004) to reduce the possibility of catheter occlusion.

[0104] Figure 10B shows in more detail an embodiment of the proximal ends of the suction catheter 110 and the catheter guide 112. In one embodiment, the catheter 110 includes a depth indicator 1100 that indicates the proper position of the catheter 110 within the catheter guide 1102. The depth indicator 1100 can include markings as a guide. In another embodiment, the depth indicator 1100 is a raised ridge, thereby preventing further insertion of the catheter 110 into the catheter guide 112.

[0105] The proximal end 1102 of the catheter 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. The vacuum source can operate continuously or intermittently to remove secretions within the receptacle 108 when connected. The proximal end 1102 of the catheter can be further adapted to a syringe for cleaning or other means. An alarm may be sounded when the catheter becomes blocked.

[0106] Figures 11A and 11B illustrate an exemplary embodiment of a hollow suction channel 1122 formed within an endotracheal tube 102. In this embodiment, an internal suction channel 1122 is disposed inside the endotracheal tube 102. For example, the suction channel 1122 can be formed by a portion of the inner wall 1124 of the endotracheal tube 102 and a longitudinal partition 1120 extending across a portion of the inner wall 1124. The section of the inner wall 1124 and the longitudinal partition 1120 are disposed 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 position aligned with or near the secretion receptacle 108 within the endotracheal tube 102.

[0107] In one embodiment, the suction channel 1122 is in fluid communication with the secretion receptacle 108 via an opening 1126 formed through the wall of the endotracheal tube 102. The opening 1126 is disposed on the rear side of the endotracheal tube 102, within or near the receptacle 108. Thus, secretions are discharged from the secretion receptacle 108, through the opening 1126, through the suction channel 1122, and to the proximal end 1128 of the endotracheal tube 102. A suction catheter (not shown) may be fluid-coupled to the proximal end 1128 of the suction channel 1122 and a vacuum such that the catheter passes through the lumen of the suction channel 1122.

[0108] In another embodiment, for example, as shown in FIG. 11B, the catheter 110 can be inserted into the suction channel 1122. In this embodiment, the suction channel 1122 is configured to receive the suction catheter 110. For example, the suction catheter 110 can have an outer diameter of 4 mm. In this case, the suction channel 1122 can have an opening larger than 4 mm, for example, an opening of 4.1 - 4.5 mm, so that the suction catheter 110 can slide within the catheter guide when removing and / or inserting a new suction catheter 110. 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 outwardly from the opening 1126 into the receptacle 108. The suction catheter 110 is in fluid communication with the receptacle 108 to remove accumulated secretions. The catheter guide 1122 includes a surface or bottom surface that is inclined across the diameter of the catheter guide at the opening 1126, and can guide and position the distal end of the catheter 110 through the opening 1126.

[0109] FIGS. 12A - 12C show schematic block diagrams of various embodiments of a secretion collection receptacle 108 implemented with a cuff assembly 100, including, for example, an inner cuff 104 and an outer bladder 106. In FIG. 12A, the secretion collection receptacle 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 a portion 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 inclined inwardly towards the outer surface 214 of the inner cuff 104 to form a valley or groove around the endotracheal tube 102. This valley or groove forms the secretion collection receptacle 108. The bottom of the collection receptacle 108 is defined by the proximal surface of the inner cuff 104, and its surface may or may not be reinforced with a material that is harder and less elastic than other parts of the inner cuff 104.

[0110] The length of the outer wall 204 of the receptacle 108 can range from 2 mm to 15 mm. The receptacle 108 extends 180 degrees behind the cuff assembly 100. The receptacle 108 helps protect the tracheal wall from aspiration trauma or direct damage by the aspiration catheter 110. The outer wall 204 forming the receptacle 108 can include a PVC sheet that seals against the tracheal wall and allows secretions to flow into the well. The rigid PVC sheet helps prevent leakage of secretions. The bottom of the receptacle 108 can include a thin plastic sheet extending from the junction of the outer surface of the inner cuff and the inner surface of the outer bladder.

[0111] Figure 12B shows an embodiment in which the proximal faces 306, 310 of both the outer bladder 106 and the inner cuff 104 are inclined inwardly toward the outer surface 304 of the endotracheal tube 102, forming a valley or groove around at least a portion of the endotracheal tube 102. This valley or groove forms the secretion collection receptacle 108.

[0112] In Figure 12C, at the rear side 408 of the ETT 102, a separate structure 1200 attached to the proximal end of the cuff assembly forms the secretion collection receptacle 108. The separate structure 1200 can be attached to one or both of the inner cuff 104 and the outer bladder 106. The separate structure 1200 can include an inclined upper surface 1202 that is inclined inwardly toward the outer surface 304 of the ETT 102 to form a valley or groove.

[0113] Figures 13A and 13B show schematic block diagrams of various embodiments of the secretion collection receptacle 108 implemented with other types of ETT cuffs 1002. Other types of ETT cuffs 1002 can include, for example, HVLP or LVHP cuffs with a single balloon, or other types of medical cuffs used with stents or other medical devices.

[0114] In FIG. 13A, the receptacle 108 is formed by at least a portion of the outer wall 1304 of the ETT cuff 1002, for example, a portion of the proximal end 1306 of the ETT cuff 1002. The outer wall 1304 extends beyond the inner wall 1302 and slopes towards the outer surface 304 of the ETT 102 to form a valley or groove around the ETT 102. This valley or groove forms the secretion collection receptacle 108.

[0115] In FIG. 13B, for example, at the rear side 408 of the ETT 102, a separate structure 1310 attached to the proximal end 1306 of the ETT cuff 1002 forms the secretion collection receptacle 108. The separate structure 1310 can include an inclined upper surface 1308 that slopes inwardly towards the outer surface 304 of the ETT 102 to form a valley or groove.

[0116] In these embodiments of FIGS. 12A - 12D, 13A, and 13B, the secretion collection receptacle 108 can completely or partially surround the ETT 102. The tip of the aspiration catheter 110 is located within or near the valley of the secretion collection receptacle 108. The collection receptacle 108 helps protect the tracheal wall from aspiration trauma or direct damage by the aspiration catheter 110. Further, the catheter guide 112 holds the tip of the aspiration catheter 110 at a position inside or near the collection receptacle 108, near the outer surface 304 of the ETT 102. This positioning of the tip of the catheter 110 also helps protect the tracheal wall.

[0117] Thus, the secretion removal system 1000 helps reduce the potential to damage the tracheal mucosa. It also helps reduce the occlusion of the opening of the tip 1004 of the catheter 110 by the cuff wall. For example, it helps prevent the cuff from being sucked into the catheter 110. The retractable catheter 110 within the catheter guide 112 makes the insertion of the ETT 102 less cumbersome. Further, the arrangement of the catheter guide allows for the use of a larger diameter catheter 110, thereby reducing the potential for occlusion.

[0118] The cuff assembly 100, the adjustment system 800, and the secretion removal system 1000 improve the protection and safety of an intubated patient. The cuff system 100 and the adjustment system 800 improve the seal with the tracheal wall without overly damaging the tracheal wall, reducing secretion leakage and lung infections. Also, the secretion removal system 1000 helps reduce the potential to damage the tracheal mucosa by using the secretion receptacle 108 and the catheter guide 112. It also helps reduce the occlusion of the opening of the tip 1004 of the catheter 110 by secretions or cuff materials. In one or more of the embodiments described herein and / or in the claims, additional or alternative advantages and improvements are possible.

[0119] As used herein, the terms "operable" or "configurable" indicate that an element includes one or more of a circuit, instructions, modules, data, one or more inputs, one or more outputs, etc. for performing one or more of the described or required corresponding functions, and may further include an assumed coupling to one or more other items for performing the described or required corresponding functions. Also, as used herein, the terms "coupled," "coupled to," "connected to," and / or "connecting" or "interconnecting" include direct connections or links between nodes / devices and / or indirect connections between nodes / devices via intervening items. Further, as used herein, an assumed connection (i.e., where an element is assumed to be connected to another element) includes both direct and indirect connections between two items, similar to "connected to." As used herein, the terms "substantially" and "about" provide an industry-accepted tolerance for the relativity between their corresponding terms and / or items.

[0120] Note that aspects of the present disclosure may be described herein as a process depicted as a schematic diagram, flowchart, flow diagram, structural diagram, or block diagram. A flowchart may describe the operations as a sequential process, but many of the operations can be performed in parallel or simultaneously. Further, the order of the operations can be rearranged. A process ends when its operations are completed. A process may correspond to a method, function, procedure, subroutine, subprogram, etc. When a process corresponds to a function, its end corresponds to the function returning to the calling function or main function.

[0121] The various features of the present disclosure described herein can be implemented in various systems and devices without departing from the present disclosure. Note that the foregoing aspects of the present disclosure are merely illustrative and should not be construed as limiting the present disclosure. The description of the aspects of the present disclosure is intended to be illustrative and not to limit the scope of the claims. Accordingly, the present teachings can be readily applied to other types of devices, and many alternatives, modifications, and variations will be apparent to those skilled in the art.

[0122] In the foregoing specification, specific representative aspects have been described with reference to specific examples. However, various modifications and changes can be made without departing from the scope of the invention as set forth in the claims. The specification and drawings are illustrative and not restrictive, and the modifications are intended to be included within the scope of the invention. Accordingly, the scope of the invention should be determined by the claims and their legal equivalents, rather than by the examples described. For example, the components and / or elements recited in the claims of any device can be assembled in various combinations or configured to operate in other ways, and thus are not limited to the specific configurations recited in the claims.

[0123] Furthermore, with respect to specific embodiments, specific benefits, other advantages, and problem solutions have been described. However, any benefit, advantage, problem solution, or any element that gives rise to or makes more explicit a specific benefit, advantage, or solution should not be construed as an important, essential, or indispensable feature or component of any or all of the claims.

[0124] As used herein, "comprise", "comprises", "comprising", "having", "including", "includes", or variations thereof are intended to refer to non-exclusive inclusion. A process, method, article, composition, or apparatus that includes a list of elements does not include only the listed elements, but may also include other elements not expressly listed, or other elements inherent to such process, method, article, composition, or apparatus. Also, other combinations and / or modifications of the structures, arrangements, uses, ratios, elements, materials, or components described above, as well as those not specifically described, can be varied or specifically adapted to particular environments, manufacturing specifications, design parameters, or other operating requirements without departing from their general principles.

[0125] Furthermore, references to elements in the singular shall mean one or more, unless specifically stated otherwise to mean “only one.” Unless specifically stated otherwise, the term “some” refers to one or more. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or become known to those of ordinary skill in the art are hereby expressly incorporated by reference and are intended to be included within the claims. Further, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is expressly recited in the claims. Unless an element of a claim is expressly recited using the phrase “means for,” and in the case of a method claim, unless recited using the phrase “step for,” no element of any claim is intended to be construed as a “means-plus-function” type element under 35 U.S.C. § 112(f).

Claims

1. A medical device, comprising: An airway tube configured to fit within the trachea; A cuff assembly mounted on a distal portion of the airway tube, the cuff assembly comprising: An inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the airway tube, the inner cuff having a first elasticity; An inflatable outer bladder disposed adjacent to the outer surface of the inner cuff, the outer bladder having a second elasticity smaller than the first elasticity of the inner cuff.

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

3. The medical device according to claim 2, wherein: The inner cuff is configured to expand to a pressure within the range of 10 cmH ２ O to 20 cmH ２ O, and the outer bladder is configured to expand to a pressure within the range of 50 cmH ２ O to 150 cmH ２ O. A medical device characterized by this is provided.

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

5. The medical device according to claim 1, further comprising: A first inflation lumen coupled to the interior of the inner cuff; and A second inflation lumen coupled to the interior of the outer bladder.

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

7. The medical device according to claim 1, wherein: The outer bladder comprises a relatively non-elastic material, the relatively non-elastic material comprising one or more of 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: Using a first pneumatic path to adjust the first pressure within the inner cuff, and ​ A medical device configured to adjust a second pressure within the outer bladder using a different second pneumatic path, wherein a 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 disposed between the inner cuff and the outer bladder, wherein the pressure sensor device measures the pressure between the cuffs.

10. The medical device according to claim 9, wherein the pressure regulator is configured to at least adjust the first pressure within the inner cuff and the second pressure within the outer bladder in response to the pressure between the cuffs.

11. A cuff assembly for a tracheal airway tube, an inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the tracheal airway tube, the inner cuff being configured to inflate within a first pressure range, and the inner cuff; an inflatable outer bladder provided adjacent to the outer surface of the inner cuff, the outer bladder being configured to inflate within a second pressure range, wherein the first pressure range is smaller than the second pressure range.

12. The cuff assembly according to claim 11, a first lumen extending from the tracheal airway tube to the inner cuff, the first lumen being fluidly coupled to the inner cuff; and a second lumen extending from the tracheal airway tube to the outer bladder, the second lumen being fluidly coupled to the outer bladder.

13. The cuff assembly according to claim 12, further comprising a pressure adjustment system configured to maintain the first pressure within the inner cuff by adding or removing air to or from the inner cuff using the first lumen and to maintain the second pressure within the outer bladder by adding or removing air to or from the outer bladder using the second lumen, wherein the first pressure is less than the second pressure.

14. The cuff assembly according to claim 13, wherein the pressure adjustment system a first air pump and a first discharge valve fluidly coupled to the first lumen and configured to add or remove air to or from the inner cuff; A cuff assembly fluidly coupled to the second lumen and including a second air pump and a second discharge valve configured to add or remove air from the outer bladder.

15. The cuff assembly according to claim 13, A pressure sensor device disposed between the inner cuff and the outer bladder, further comprising a pressure sensor device for measuring the pressure between the cuffs, The pressure adjustment system is configured to adjust a first pressure in the inner cuff and a second pressure in the outer bladder in response to the cuff pressure. A cuff assembly characterized by that.

16. The cuff assembly according to claim 11, A secretion collection receptacle disposed at the proximal end of the cuff assembly; A suction channel including a distal end proximate to the secretion collection receptacle and a proximal end provided at the proximal end of the tracheobronchial tube, the proximal end of the suction channel being in fluid communication with a vacuum. A cuff assembly characterized by that.

17. The cuff assembly according to claim 16, The secretion collection receptacle, An outer wall of the cuff assembly that extends proximally from the proximal surface of the cuff assembly and forms a groove for collecting secretions, the groove being located at least on the posterior side of the tracheobronchial tube. A cuff assembly characterized by that.

18. The cuff assembly according to claim 16, The suction channel includes a catheter, and the cuff assembly, Further comprising a catheter guide configured to hold the catheter, the catheter guide being located on the front side of the outer surface at the proximal end of the endotracheal tube, The catheter guide is characterized by looping around to a position on the posterior side of the outer surface at the distal end of the endotracheal tube. A cuff assembly.

19. A medical device, A tracheobronchial tube configured to fit within the trachea, A cuff assembly mounted at the lower end of the tracheobronchial tube, An inflatable inner cuff having an inner surface and an outer surface, the inner surface being disposed adjacent to the tracheobronchial tube, the inner cuff having a first elasticity; an inner cuff, An inflatable outer bladder disposed adjacent to the outer surface of the inner cuff, the outer bladder having a second elasticity smaller than the first elasticity of the inner cuff; a cuff assembly including, A pressure regulator, A first pressure is set for the inner cuff, and configured to set a second pressure for the outer bladder, the medical device comprising a pressure regulator in which a first pressure of the inner cuff is less than a second pressure of the outer bladder. **Claim 20** In the medical device according to claim 19, a first inflation lumen coupled to inflate the inner cuff, and a second inflation lumen coupled to inflate the outer bladder.

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