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BR-112024027130-B1 - SYSTEM AND METHOD FOR AN ENDOTRACHEAL TUBE CUFF ASSEMBLY

BR112024027130B1BR 112024027130 B1BR112024027130 B1BR 112024027130B1BR-112024027130-B1

Abstract

SYSTEM AND METHOD FOR AN ENDOTRACHEAL TUBE CUFF ASSEMBLY. An airway tube cuff assembly includes an outer bag and an inner cuff. The inner cuff is positioned adjacent to the airway tube, and the outer bag is positioned adjacent to the inner cuff. The outer bag is made of a less elastic material and operates at a relatively higher pressure. The inner cuff is made of a more elastic or hyperelastic material and operates at a relatively lower pressure. A pressure controller independently adjusts the pressure within the inner cuff and the outer bag. A secretion collection receptacle is formed by the cuff assembly and is evacuated via a catheter or suction channel.

Inventors

  • KEVIN CHONG KIM

Assignees

  • KEVIN CHONG KIM

Dates

Publication Date
20260310
Application Date
20230207
Priority Date
20220623

Claims (18)

  1. 1. A system (100, 102, 800, 1000) for an endotracheal tube cuff assembly (100), comprising: an endotracheal tube (102) constructed to fit inside a trachea, characterized by further comprising: a cuff assembly (100) implemented at a lower end of the endotracheal tube, which includes: an inflatable inner cuff (104) with an inner surface (302) and an outer surface (214), wherein the inner surface is positioned adjacent to the endotracheal tube and wherein the inner cuff has a first elasticity; an inflatable outer bag (106) positioned adjacent to the outer surface of the inner cuff, wherein the outer bag has a second elasticity that is less than the first elasticity of the inner cuff, wherein the inner cuff is configured to be inflated in a first pressure range and wherein the outer bag is configured to be inflated in a second pressure range, wherein the first pressure range is less than the second pressure range.
  2. 2. System, according to claim 1, characterized in that the inner cuff is configured to be inflated to a first pressure in the first pressure range of 10 cm H2O to 20 cm H2O and the outer bag is configured to be inflated to a second pressure in the second pressure range of 50 cm H2O to 150 cm H2O.
  3. 3. System, according to claim 1, characterized in that the outer surface (204) of the outer bag is configured to have a relatively smooth surface during filling.
  4. 4. System, according to claim 1, characterized in that it further comprises: a first inflation lumen (220) coupled to the interior of the inner cuff; and a second inflation lumen (218) coupled to the interior of the outer bag.
  5. 5. System according to claim 1, characterized in that the inner cuff comprises a relatively elastic material, wherein the relatively elastic material includes one or more of the following: silicone, latex, polyvinyl chloride (PVC), neoprene, polyisoprene or polyurethane (PU).
  6. 6. System according to claim 1, characterized in that the outer bag comprises a relatively inelastic material, wherein the relatively inelastic material includes one or more of the following: polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene or polyurethane (PU).
  7. 7. System, according to claim 1, characterized in that it further comprises: a secretion collection receptacle (108) positioned at a proximal end of the cuff assembly; and a suction channel (1122) that includes a distal end close to the secretion collection receptacle and a proximal end of the suction channel at a proximal end of the endotracheal tube, wherein the proximal end of the suction channel is in fluid communication with a vacuum.
  8. 8. System, according to claim 7, characterized in that the secretion collection receptacle comprises: an outer wall of the cuff assembly that extends proximally from a proximal surface of the cuff assembly forming a channel for secretion collection, wherein the channel is positioned at least on one posterior side of the endotracheal tube; and an inclined proximal surface that slopes inward toward the outer wall towards the upper surface of the cuff assembly forming the channel for secretion collection.
  9. 9. System, according to claim 7, characterized in that the secretion collection receptacle includes an outer wall that extends from a proximal end of the outer pouch to form a channel with a proximal surface of the inner cuff and/or a proximal surface of the outer pouch.
  10. 10. System, according to claim 7, characterized in that the suction channel includes a catheter (110) and further comprises: a catheter guide (112) configured to hold the catheter, wherein the catheter guide is positioned on an anterior side of an external surface at a proximal end of the endotracheal tube; and wherein the catheter guide rotates circumferentially to a position on the posterior side of the external surface at the distal end of the endotracheal tube.
  11. 11. System, according to claim 7, characterized in that the suction channel is positioned internally in the 4/6 endotracheal tube and extends into the posterior part of the inner wall of the endotracheal tube; and wherein the endotracheal tube forms an opening (1126) close to the secretion collection receptacle, wherein the suction channel allows communication of fluids with the secretion collection receptacle through the opening for secretion evacuation.
  12. 12. A system (100, 102, 800, 1000) for an endotracheal tube cuff assembly (100), comprising an endotracheal tube (102) configured to fit inside a trachea, characterized by further comprising a cuff assembly (100) implemented at a lower end of the endotracheal tube, which includes: an inflatable inner cuff (104) with an inner surface (302) and an outer surface (214), wherein the inner surface is positioned adjacent to the endotracheal tube and wherein the inner cuff has a first elasticity; an inflatable outer bag (106) positioned adjacent to the outer surface of the inner cuff, wherein the outer bag has a second elasticity that is less than the first elasticity of the inner cuff; and a pressure regulator (800) configured to: adjust a first pressure on the inner cuff using a first pneumatic path; Adjusting a second pressure in the external bag using a different secondary pneumatic conduit, where the first pressure in the internal cuff is lower than the second pressure in the external bag.
  13. 13. System, according to claim 12, characterized in that it further comprises: a pressure sensing device (602) positioned between the inner cuff and the outer bag, wherein the pressure sensing device measures an intercuff pressure.
  14. 14. System, according to claim 13, characterized in that the pressure regulator is configured to at least adjust the first pressure in the inner cuff and the second pressure in the outer bag in response to the intercuff pressure.
  15. 15. A system for an endotracheal tube cuff assembly (100), comprising an endotracheal tube (102), characterized in that it comprises: an inflatable inner cuff (104) with an inner surface (302) and an outer surface (214), wherein the inner surface is positioned adjacent to the endotracheal tube and wherein the inner cuff has a first elasticity; a first lumen (220) extending from the endotracheal tube to the inner cuff, wherein the first lumen is fluidically coupled to the inner cuff; an inflatable outer bag (106) positioned adjacent to the outer surface of the inner cuff, wherein the outer bag has a second elasticity that is less than the first elasticity of the inner cuff; and a second lumen (218) extending from the endotracheal tube to the outer bag, wherein the second lumen is fluidically coupled to the outer bag.
  16. 16. The system of claim 15, characterized in that it further comprises: a pressure regulating system (800) configured to maintain a first pressure within the inner cuff using the first lumen to add or remove air from the inner cuff and to maintain a second pressure within the outer bag using the second lumen to add or remove air from the outer bag, wherein the first pressure is less than the second pressure.
  17. 17. The system of claim 16, characterized in that the pressure regulating system comprises: a first air pump (822b) and a first release valve (824b) fluidly coupled to the first lumen and configured to add or remove air from the inner cuff; and a second air pump (822a) and a second release valve (824a) fluidly coupled to the second lumen and configured to add or remove air from the outer bag.
  18. 18. The system of claim 16, characterized in that it further comprises: a pressure sensing device (602) positioned between the inner cuff and the outer bag, wherein the pressure sensing device measures an intercuff pressure; and wherein the pressure regulating system is configured to adjust the first pressure in the inner cuff and the second pressure in the outer bag in response to the intercuff pressure.

Description

PRIORITY CLAIM [001] This application claims priority and benefit of patent application No. 17/848,273 filed with the United States Patent Office on June 23, 2022, the entire contents of which are incorporated herein by reference as if fully set forth below in their entirety and for all applicable purposes. FIELD [002] This application relates to a system and methods for a cuff (balloon) assembly implemented in a medical device and, more particularly, a cuff assembly implemented within an airway tube, a pressure regulating system for the cuff assembly and a secretion clearance system. CONTEXT [003] Currently, there are two main types of cuffs: low-volume, high-pressure (LVHP) cuffs and high-volume, low-pressure (HVLP) cuffs. The first type, LVHP cuffs, are made of more rigid and relatively inelastic materials. Due to their inherent rigidity, a higher pressure level (50 cm H2O to 100 cm H2O) is required to inflate LVHP cuffs. As a result, LVHP cuffs cause excessively high pressure on the tracheal mucosa, even when inflated to a minimum pressure to create a seal with the tracheal wall. This high pressure causes an unacceptably high incidence of tracheal ischemia and necrosis, for example, an incidence rate of 5% to 20%. Despite this, a crucial advantage of LVHP cuffs, when inflated, is the relative absence of folds or wrinkles, resulting in superior tracheal sealing. LVHP cuffs were first used in the 1960s, but today they have been largely replaced by HVLP cuffs. [004] HVLP cuffs are composed of more elastic and flexible materials that inflate at lower pressures. To compensate for the lower pressure characteristics and create a seal on the tracheal wall, the diameter of HVLP cuffs is generally 1.5 to 2 times the diameter of the trachea when fully inflated. However, increasing the volume of HVLP cuffs requires a significant amount of material, which increases the volume of the HVLP cuff, making intubation more difficult. In addition, excess material tends to form wrinkles or folds due to "incomplete inflation." These wrinkles or folds often create pathways for orogastric secretions to pass beyond the HVLP cuff, ultimately leading to microaspiration and lung infection. [005] When examining the effect of cuff pressure on the trachea, it is important to bear in mind that the capillary perfusion pressure of the tracheal wall mucosa in humans ranges from 22 to 32 mmHg, and tracheal mucosal blood flow can be compromised at pressures applied above 30 cm H2O (22 mmHg), with total occlusion of flow to certain parts at 50 cm H2O (37 mmHg). It is evident, therefore, that there is only a small overlap between the safe pressure range and the complication range. The window of effectiveness and safety is, in fact, very narrow, or even non-existent. [006] The pressure required for standard HVLP cuffs to achieve reasonable inflation with an acceptable number of folds or wrinkles is approximately 32 cm H2O. Guidelines established by various medical societies and organizations recommend maintaining HVLP cuff pressure in a range of 20 cm H2O to 30 cm H2O to avoid occlusion of tracheal mucosal blood flow. However, even with strict adherence to recommendations, many patients are still placed at risk. In fact, one study showed that approximately 10% of mechanically ventilated patients develop ventilator-associated pneumonia (VAP), and the mortality rate for VAP is estimated at 13%. Furthermore, patients with VAP face longer hospital stays and incur higher healthcare costs than patients with similar conditions without VAP. Considering that in the US there are approximately 750,000 patients annually requiring ventilation, the human and financial costs of VAP are enormous. [007] Unfortunately, studies have shown that even at pressures up to 60 cm H2O, microaspiration still occurs with HVLP cuffs, suggesting the continued presence of wrinkles in the cuff, allowing the passage of secretions, even at higher pressures. Therefore, although HVLP cuffs appear superior because they are able to produce a seal at a lower pressure level and prevent necrosis of the tracheal wall, they are still far from ideal. [008] Although the main objectives of the tracheal cuff, to provide maximum airway seal and cause minimal airway damage, are simple and straightforward, successfully achieving these objectives has been difficult. This failure persists despite the various modifications and advancements made regarding materials, shape, and volumetric structure. Therefore, there is a need for an improved cuff system that helps reduce microaspiration and lung infection while maintaining a good seal with the tracheal wall, but without unnecessarily damaging it. SUMMARY [009] In one aspect, a medical device includes an airway tube configured to fit within a trachea and a cuff assembly implemented on a distal portion of the airway tube. The cuff assembly includes an inflatable inner cuff with an inner surface and an outer surface, wherein the inner surface is posit