Systems and methods for tracheostomy tube having secondary airflow opening and double sleeve assembly

Abstract

A sleeve assembly for a tracheostomy tube includes an outer bladder and an inner sleeve. An inner sleeve is positioned adjacent the tracheostomy tube, and an outer bladder is positioned adjacent the inner sleeve. The outer bag is made of materials with small elasticity and works under high relative pressure. The inner sleeve is made of elastic or hyperelastic materials and works under low relative pressure. A secondary airflow opening is formed in a sidewall of the tracheostomy tube between the sleeve assembly and the primary distal opening of the tracheostomy tube.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. patent application No. 17 / 902,691, filed on September 2, 2022, entitled “System and Method for a Tracheostomy Tube with a Secondary Airflow Opening and a Dual Cuff Assembly,” which claims priority under 35 U.S.C. §120 as a continuation-in-part of U.S. patent application No. 17 / 848,273, filed on June 23, 2022, entitled “System and Method for an Endotracheal Tube Cuff Assembly,” Technical Field

[0003] The present application relates to systems and methods for cuff assemblies implemented in medical devices, and more particularly, to tracheostomy tubes having secondary airflow openings, cuff assemblies, and secretion collection and removal systems. Background Art

[0004] Tracheostomy tube is usually an L-shaped tube, including flange, outer sleeve, inner sleeve and sleeve. The outer sleeve is divided into a proximal section, a curved section and a distal section. The proximal section and the distal section of the tracheostomy tube are relatively straight and connected by an intermediate curved section. The distal section and the curved section are surgically inserted into the patient through a tracheostomy stoma (a hole formed in the neck and trachea), and the distal section is placed along the longitudinal axis of the trachea. The proximal section extends from the tracheostomy stoma in a direction that is almost 90 degrees with the distal section. The flange extends from the side of the proximal part to stabilize the tracheostomy tube outside the tracheostomy stoma. The flange includes a slit or hole located on the opposite end to connect the cloth band or belt wrapped around the neck. The inner sleeve is fitted to the outer sleeve inside, and can be removed or replaced to keep the tracheostomy tube clean.

[0005] An inflatable cuff is disposed on the distal section of the tracheostomy tube and is located within the trachea. The inflation tube is connected to a viewing balloon and a one-way inflation valve for inflating the cuff. In known tracheostomy tubes, the inflatable cuff occupies almost the entire length of the distal section and helps prevent fluid from leaking into the patient's lungs.

[0006] Then when the patient has airway stenosis or obstruction near the trachea (upper airway), the tracheostomy tube is connected to a ventilator and provides a breathing passage for the patient. This upper airway obstruction may be caused by infection, tumor, trauma or bleeding. For patients with acute airway obstruction, a tracheostomy tube may become a life-saving tool. However, if the tracheostomy tube is blocked, the patient will not have other ways to breathe, so the occlusion may be fatal. Unfortunately, the occlusion of the main tracheostomy tube opening is not uncommon. The most common cause of occlusion is the kink or displacement of thick secretions, mucus plugs, blood clots, foreign bodies or pipes.

[0007] Currently, tracheostomy tubes have systems for removing this secretion, but such systems are not ideal and often fail to prevent blockage.

[0008] Furthermore, the main purpose of an inflatable cuff is to provide maximum airway seal with minimal damage to the airway. Although this goal seems simple and straightforward, it remains difficult to achieve successfully. Despite various modifications and improvements in materials, shapes, and volume structures, this goal has eluded breakthroughs.

[0009] In view of the above shortcomings described in this specification, there is a need for an improved tracheostomy tube that provides a way for the patient to breathe in the event that the main tracheostomy tube opening becomes occluded. In addition, there is a need for an improved system and method for secretion collection and removal to help prevent tracheostomy tube occlusion. In addition, there is a need for an improved cuff system that helps reduce microaspiration and infection of the lungs by maintaining a good seal with the tracheal wall while avoiding excessive damage to the tracheal wall. Summary of the invention

[0010] In one aspect, a tracheostomy tube comprises an outer sleeve having a distal section, wherein the distal section comprises a primary distal opening. The tracheostomy tube further comprises: a sleeve assembly located at the distal section of the tracheostomy tube. The sleeve assembly comprises an inflatable inner sleeve having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the outer sleeve; and an inflatable outer bladder positioned adjacent to the outer surface of the inner sleeve. The inner sleeve has a first elasticity and the outer bladder has a second elasticity, the second elasticity being less than the first elasticity of the inner sleeve. The distal section also forms a secondary airflow opening located between the sleeve assembly and the primary distal opening.

[0011] In another aspect, a tracheostomy tube includes a cuff assembly, the cuff assembly comprising: an inflatable inner cuff having an inner surface and an outer surface, wherein the inner cuff is configured for a first pressure range; and an inflatable outer bladder positioned adjacent to the outer surface of the inner cuff, wherein the outer bladder is configured for a second pressure range, wherein the first pressure range of the inner cuff is lower than the second pressure range of the outer bladder. The tracheostomy tube includes an outer sleeve having a distal primary opening, wherein the inner surface of the cuff assembly is positioned adjacent to the outer sleeve, and wherein the outer sleeve forms a secondary airflow opening between the cuff assembly and the primary distal opening.

[0012] In one or more of the above aspects, the secondary airflow openings include a plurality of openings formed on a side wall of the distal section between the sleeve assembly and the primary distal opening.

[0013] In one or more of the above aspects, the plurality of openings each have an inclined wall, wherein an inner opening of each of the plurality of openings is more distal than an outer opening of each of the plurality of openings.

[0014] In one or more of the above aspects, an inner sleeve is disposed inside the outer sleeve, and the secondary airflow opening formed in the outer sleeve includes at least one opening that substantially exposes the plurality of openings formed in the inner sleeve.

[0015] In one or more of the above aspects, the secondary airflow openings formed in the outer sleeve include a first plurality of openings formed in the outer sleeve that are generally aligned with a second plurality of openings formed in the inner sleeve. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 A front perspective view of an exemplary embodiment of a tracheostomy tube with secondary airflow openings is illustrated.

[0017] Figure 2 A front perspective view of an exemplary embodiment of a tracheostomy tube is illustrated.

[0018] Figure 3 A cross-sectional view of an exemplary embodiment of a tracheostomy tube is illustrated.

[0019] Figure 4 A cross-sectional view of an exemplary embodiment of a tracheostomy tube is illustrated.

[0020] Figure 5A Exemplary embodiments of an inner cuff of a tracheostomy tube are illustrated.

[0021] Figure 5BA side view of another exemplary embodiment of a secondary airflow opening for a tracheostomy tube is illustrated.

[0022] Figure 5C A side view of another exemplary embodiment of a secondary airflow opening for a tracheostomy tube is illustrated.

[0023] Figure 6 A side perspective view of another exemplary embodiment of a tracheostomy tube with a second exemplary embodiment of a cuff system is illustrated.

[0024] Figure 7 Another side perspective view of an exemplary embodiment of a tracheostomy tube with a second exemplary embodiment of a cuff system is illustrated.

[0025] Figure 8 A cross-sectional view of an exemplary embodiment of a tracheostomy tube with a second exemplary embodiment of a cuff system is illustrated.

[0026] Fig.9A , Fig. 9B and Fig. 9C A block diagram illustrating a cross-sectional view of an embodiment of a sleeve system.

[0027] Fig.10 A block diagram illustrating an embodiment of a tracheostomy tube having multiple pressure sensors is illustrated.

[0028] Fig.11 A schematic block diagram of an exemplary embodiment of a pressure regulator and control system for a cuff assembly is illustrated.

[0029] Fig.12 A flow chart illustrating an embodiment of one or more methods for monitoring and controlling pressure of a cuff assembly. DETAILED DESCRIPTION

[0030] The wording "exemplary" or "embodiment" is used herein to mean "serving as an example, instance, or illustration." Any implementation or aspect described herein as "exemplary" or "embodiment" is not necessarily to be construed as preferred or advantageous over other aspects of the invention. Likewise, the wording "aspects" does not require that all aspects of the disclosure include the discussed feature, advantage, or mode of operation.

[0031] Embodiments will now be described in detail with reference to the accompanying drawings. In the following description, many specific details are set forth in order to provide a thorough understanding of the aspects described herein. However, those skilled in the art will appreciate that these and other aspects may be practiced without some or all of these specific details. In addition, in order not to obscure the various aspects of the present disclosure, well-known steps in the methods of the process may be omitted from the flowcharts presented herein. Similarly, well-known components in the device may be omitted from the drawings and descriptions thereof presented herein to avoid confusing the various aspects of the present invention.

[0032] Embodiment of the secondary air flow opening

[0033] Figure 1 A front perspective view of an exemplary embodiment of a tracheostomy tube 100 having a secondary airflow opening 128 is illustrated. The tracheostomy tube 100 includes an outer sleeve 102 and an inner sleeve 150, wherein the inner sleeve is positioned inside the outer sleeve. The outer sleeve 102 and the inner sleeve 150 may include a soft polyvinyl chloride (PVC) material.

[0034] The outer sleeve 102 includes a proximal section 112, a curved middle section 114, and a distal section 116. The proximal section 112 of the outer sleeve 102 includes a flange 108 or plate extending circumferentially outward from the outer sleeve. The flange 108 includes two slits 118a, 118b on opposite sides. A cotton bandage or strap is fixed in the slits 118a, 118b of the flange to keep the tracheostomy tube 100 on the patient's neck. The proximal section 112 also includes a hub 110 extending outward from the flange 108. The inner sleeve 150 is inserted through the proximal opening in the hub 110. The proximal end of the inner sleeve 150 is then connected to the ventilator.

[0035] The outer sleeve 102 of the tracheostomy tube 100 includes a curved middle section 114, and a distal section 116, which is configured to fit within the trachea of ​​a patient. The middle section 114 is curved so that the proximal section 112 is at an angle of between about 80 degrees and about 90 degrees to the distal section 116. The distal section 116 includes a sleeve assembly 120, a distal end 126, and a main distal opening 138. The main distal opening 138 is an opening at the distal end of the tracheostomy tube 100, such as an opening formed by the end of the tracheostomy tube 100. For example, the main distal opening 138 is formed between the distal bottom surface 140 of the wall 132 of the outer sleeve 102 and the distal bottom surface 142 of the wall of the inner sleeve 150, if present.

[0036] The sleeve assembly 120 includes an inner sleeve 124 and an outer bladder 122, as described in more detail below.

[0037] Due to structural limitations, it is not possible to have a secondary airflow opening on currently known tracheostomy tubes. The primary limitation is the lack of necessary space on the distal end 126 between the inflatable cuff and the primary distal opening 138. The secondary airflow opening must have a total area sufficient to maintain airflow for patient breathing in the event of occlusion of the primary distal opening 138. As described above, in currently known tracheostomy tubes, the inflatable cuff occupies almost the entire length of the distal section 116. As such, the length of the distal end 126 from the inflatable cuff to the primary distal opening 138 is insufficient for the secondary airflow opening.

[0038] The present specification describes a novel sleeve assembly 120 having a length less than a typical inflatable sleeve. For example, the length L of the sleeve assembly is CA In the range of about 10 millimeters (mm) to about 20 mm, this is in contrast to about 30 mm on current tracheostomy tubes. As the length of this novel cuff assembly 120 is shortened, the length of the distal end 126 exposed between the cuff assembly 120 and the primary distal opening 138 is increased. This increased exposed length of the distal end 126 allows for a secondary airflow opening 128. The secondary airflow opening 128 is formed on the side (edge) wall 132 of the distal section 116 between the cuff assembly 120 and the primary distal opening 138. In the event that the primary opening 138 of the tracheostomy tube is occluded, the secondary airflow opening 128 serves as an alternative channel for the patient to breathe.

[0039] In this embodiment, the secondary airflow openings 128 include a plurality of apertures 130 formed in the wall 132 of the outer sleeve 102 and the wall of the inner sleeve 150. The apertures 130 in the outer sleeve 102 must be substantially aligned with the apertures in the inner sleeve 150. For example, to be substantially aligned, the apertures 130 in the outer sleeve 102 must be aligned with at least about 80% of their corresponding apertures in the inner sleeve 150. The alignment of the outer sleeve 102 and the inner sleeve 150 is guided by the suction channel 136 and the suction conduit 134, as described in more detail below.

[0040] In one example, the diameter of each aperture 130 is between 1 mm and 3 mm, wherein the total area of ​​the plurality of apertures is equal to about 20 square millimeters to about 80 square millimeters (depending on the length L of the distal end). DE ) to provide adequate airflow. Other sizes of openings and total areas of the fenestrations 130 may also be used. The fenestrations 130 are spaced a certain distance apart to maintain a sufficient amount of material of the outer sleeve 102 to ensure its structural integrity. Thus, when the primary distal opening 138 is occluded, the plurality of fenestrations 130 provide a secondary airflow opening 128 for adequate ventilation.

[0041] In an embodiment, each fenestration 130 has a slanted or skewed wall, for example, the wall is at an angle relative to the centerline of the distal end 126. For example, the inner opening of the fenestration 130 is more distal than the outer opening. The angle of the fenestration wall relative to the centerline of the distal end 126 can be between 10 and 45 degrees. This configuration of the fenestration 130 helps prevent the tip of the suction catheter from getting stuck on the inner opening of the fenestration 130.

[0042] Embodiment of the double sleeve assembly

[0043] The tracheostomy tube 100 includes a novel cuff assembly 120 disposed at the distal section 116. Currently, there are two main types of cuffs: low volume high pressure (LVHP) cuffs and high volume low pressure (HVLP) cuffs. The first type of LVHP cuff is made of a harder, relatively inelastic material. Due to its inherent stiffness, higher pressure levels (50 cm H2O to 100 cm H2O) are required to inflate the LVHP cuff. As a result, the LVHP cuff generates excessive pressure on the tracheal mucosa, even when inflated to a minimum pressure to form a seal with the tracheal wall. This high pressure leads to an unacceptably high incidence of tracheal ischemia and necrosis, such as an incidence of 5% to 20%. Nevertheless, a key advantage of the LVHP cuff when inflated is the relative absence of wrinkles or wrinkles, resulting in an excellent tracheal seal. The LVHP cuff was first used in the mid-1960s, but has now been widely replaced by the HVLP cuff.

[0044] The HVLP cuff is composed of a more elastic and compliant material that inflates at lower pressures. To compensate for the lower pressure characteristics and form a seal against the tracheal wall, the diameter of the HVLP cuff is typically 1.5 to 2 times the tracheal diameter when fully inflated. However, the increased volume of the HVLP cuff requires a significant amount of cuff material, which increases the bulk of the HVLP cuff, making intubation more difficult. In addition, the excess material has a tendency to form wrinkles or folds due to "incomplete inflation." These wrinkles or folds often create a path for orogastric secretions to pass through the HVLP cuff, ultimately leading to microaspiration and lung infection.

[0045] In examining the effects of cuff pressure on the trachea, it is important to remember that the capillary perfusion pressure of the human tracheal wall mucosa ranges from 22 to 32 mmHg and that tracheal mucosal blood flow may be compromised at applied pressures above 30 cm H2O (22 mmHg), with blood flow to some segments completely blocked at 50 cm H2O (37 mmHg). Therefore, it is clear that there is only a small overlap between the safe pressure range and the complication pressure range. In practice, the window of effectiveness and safety is very narrow or even nonexistent.

[0046] The pressure required to achieve reasonable inflation of a typical HVLP cuff with an acceptable number of folds or wrinkles is approximately 32 cmH2O. Guidelines developed by various medical societies and organizations recommend that HVLP cuff pressures be maintained in the range of 20 cmH2O to 30 cmH2O to avoid obstruction of tracheal mucosal blood flow. However, even with strict adherence to these recommendations, many patients are still at risk. In fact, one study showed that approximately 10% of patients receiving mechanical ventilation developed ventilator-associated pneumonia (VAP), and the mortality rate of VAP was estimated to be 13%. In addition, patients with VAP require longer hospital stays and have higher medical costs compared to similarly ill patients without VAP. Considering that approximately 750,000 patients in the United States require ventilators each year, the human and economic losses caused by VAP are enormous.

[0047] Unfortunately, studies have shown that microsucking of the HVLP cuff occurs even at pressures as high as 60 cm H2O, suggesting that even at higher pressures the cuff continues to have wrinkles that allow secretions to pass through. Therefore, even though HVLP cuffs appear superior due to their ability to create a seal at lower pressure levels and avoid tracheal wall necrosis, they are still far from ideal.

[0048] Refer to Figure 1 , the cuff assembly 120 is now described in more detail. Unlike previously known cuffs, the cuff system 120 includes at least two independently controlled inflatable balloons. The cuff assembly 120 includes a first inner cuff 124 positioned around and adjacent to the outer sleeve 102, the first inner cuff 124 being configured to expand radially outward from the tracheostomy tube 100. A second annular outer balloon 122 is positioned around and adjacent to the inner cuff 124, wherein at least a portion of the inner cuff 124 is located between the outer balloon 122 and the tracheostomy tube 100. The outer balloon 122 is configured to expand radially outward from the inner cuff 124 so that the outer surface of the outer balloon 122 contacts the tracheal wall.

[0049] The inner sleeve 124 and the outer bag 122 can be cylindrical or annular. Figure 1 As shown, when inflated, the outer balloon 122 is a ring in the shape of a torus with a circular cross-section. The inner sleeve 124 has a cylindrical shape with an arched outer surface that forms a ring around the tracheostomy tube 100. In this example, the length of the inner sleeve is in the range of 10 mm to 20 mm, and the length of the outer sleeve is in the range of 5 mm to 9 mm. The outer balloon 122 is bonded to the inner sleeve 124 without being constrained to the outer sleeve 102 of the tracheostomy tube 100. The inner sleeve 124 is attached to the outer sleeve 102 by adhesive and / or straps.

[0050] The inner sleeve 124 and the outer bag 124 have separate inflation devices. For example, the first inflation tube 106a is positioned in the first channel of the outer sleeve 102 and includes a distal end connected to the inner sleeve 124. The proximal end of the first inflation tube 106a extends from the hub 110 and is connected to an observation balloon and a one-way inflation valve for inflation of the inner sleeve 124. A separate second inflation tube 106b is positioned in the second channel of the outer sleeve 102 and includes a distal end connected to the outer bag 122. The proximal end of the second inflation tube 106b extends from the hub 110 and is connected to an observation balloon and a one-way inflation valve for inflation of the outer bag 122.

[0051] Due to the separate inflation tubes 106a, 106b, the outer bladder 122 and the inner cuff 124 can be inflated to and maintained at different pressures. In an embodiment, the inner cuff 124 is a low-pressure inflatable cuff and is configured to function in a low pressure range of 10cm H2O to 20cm H2O. In contrast, the outer inflation bladder 122 is configured to be inflated to a higher pressure range of 50cm H2O to 150cm H2O. Therefore, the inner cuff 124 operates in a pressure range lower than the pressure range of the outer bladder 122.

[0052] In addition, the inner sleeve 124 includes a relatively elastic material and the outer bladder 122 includes a relatively inelastic material, for example, the material of the outer bladder 122 is less elastic than the material of the inner sleeve 124. For example, the relatively elastic material of the inner sleeve 124 may include one or more of the following: rubber, silicone, latex, polyvinyl chloride (PVC), neoprene, polyisoprene, or polyurethane (PU). The relatively inelastic material of the outer bladder 122 may include one or more of the following: polyethylene terephthalate (PETP), low density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, or polyurethane (PU).

[0053] In use, e.g., when inserted into the trachea and subsequently pressurized to an expanded state, the first inner cuff 124 behaves as an HVLP-type cuff, while the second outer balloon 122 behaves as an LVHP-type cuff. The more compliant inner cuff 124 is able to regulate the pressure exerted on the tracheal wall by the higher pressurized outer balloon 122 ("tracheal pressure"). In other words, the lower pressure, more resilient inner cuff 124 is configured to absorb excess pressure that might otherwise be exerted on the tracheal wall by the outer balloon 122. For example, due to the greater compliance and resiliency of the inner cuff 124, the cuff assembly 120 exerts a lower total pressure / force on the tracheal wall, e.g., lower than the outer balloon pressure. The force of the inner cuff 124 acts radially on the outer balloon 122 and therefore represents the force ultimately exerted on the trachea as the tracheal pressure. Thus, the radial force generated by the inner cuff 124 and acting on the outer balloon 122 is the tracheal pressure. For example, when the outer balloon pressure is greater than the inner cuff pressure, and the outer balloon is inflated so that the outer surface contacts the trachea, the cuff pressure is the same as the tracheal pressure.

[0054] In addition, due to its operation at high pressures, the outer balloon 122 in the expanded state forms a relatively smooth surface with fewer folds or wrinkles, for example, compared to an LVHP cuff. This reduction in wrinkles reduces the risk of leaks and creates a more uniform tracheal seal.

[0055] Thus, the cuff assembly 120 utilizes a novel system to titrate tracheal pressure, thereby reducing tracheal complications. By combining the characteristics of HVLP and LVHP cuffs into one system, the cuff system 120 utilizes the advantages found in both types of cuffs: excellent tracheal seal with greater safety to the trachea. The cuff system 120 features an excellent seal to the tracheal wall with reduced tracheal trauma. Thus, the cuff assembly 120 helps protect the lungs from contamination with orogastric contents or blood without causing undue damage to the tracheal wall.

[0056] In an embodiment, the tracheostomy tube 100 also includes a secretion removal system for removing secretions, aspirates, or other fluids that may accumulate around the proximal side of the sleeve assembly 120. The aspiration channel 136 is formed in the rear portion of the outer sleeve 102 and extends from the hub 110 to a point just proximal to the inner sleeve 122, where it forms an opening. In one example, the inner sleeve 150 has a cylindrical L-shape with a rear outer wall recess configured to form an upper portion of the aspiration channel 136, as shown in FIG. Figure 5A The outer sleeve 102 has a cylindrical L-shape with a rear inner wall recess configured to form a lower portion of the suction passage 136 .

[0057] An opening is formed in the outer wall of the cannula 102 that fluidly connects the suction channel 136 to the trachea, as described with respect to Figure 3 and Figure 4100. The opening is preferably on the rear side of the outer sleeve 102, proximal to the sleeve assembly 120. The suction conduit 134 is attached to the proximal end of the suction channel 136 at the hub 110. A vacuum device can then be attached to the suction conduit 134 to remove secretions or other fluids that accumulate on the proximal side of the sleeve assembly 102. Thus, the suction channel 136 is implemented within the tracheostomy tube 100. The suction channel 136 can be used to suction secretions from the trachea at periodic intervals or continuously.

[0058] Figure 2 A front perspective view of an exemplary embodiment of a tracheostomy tube 100 is illustrated. Figure 2 As shown, the outer diameter D of the hub 110 OH is larger than the outer diameter D of the distal end section 112 of the outer sleeve 102 ODS The flange 108 extends outwardly between the distal side of the hub 110 and the distal end section of the outer sleeve 102. A section EE and a section GG are also defined.

[0059] Figure 3 A cross-sectional view of an exemplary embodiment of a tracheostomy tube 100 is illustrated. The cross-sectional view is taken along Figure 2 1 and 10. The cross-sectional line EE defined in FIG. 1 and illustrates the first inflation line 106a, which is positioned in the first channel 300. The first channel 300 is formed between the inner wall 302b and the outer wall 302a of the outer sleeve 102. The channel 300 extends from the proximal side of the flange (e.g., at the hub 110) to at least the sleeve assembly 102 on the front side of the outer sleeve 102. The distal end 306 of the inflation tube 106a extends into the inner sleeve 124 through the opening 304 in the outer wall 302a of the outer sleeve 102. The inflation tube 106a forms an airtight fluid connection for inflation of the inner sleeve 102.

[0060] A suction channel is provided in the wall of the outer sleeve on the rear side of the tracheostomy tube 100. The proximal end 316 of the suction channel 136 is located proximal to the flange 108 and includes an opening for inserting the suction catheter 134 through the channel 314 formed in the hub 110. A vacuum device or syringe is then coupled to the suction catheter 134 to evacuate the suction channel 136 periodically or continuously.

[0061] At the distal end of the suction channel 136, an opening 310 is formed in the rear outer wall of the outer sleeve 102. The opening 310 is located proximal to the sleeve assembly 120. The opening 310 allows secretions and other fluids accumulated around the sleeve assembly 120 to flow into the suction channel 136 for drainage. In another embodiment, for example, regarding Figures 7 and 8 As depicted, the suction conduit 134 may extend the length of the suction channel 136 and extend to or through the opening 310 .

[0062] The stopper 312 is located in the channel 136 distally relative to the opening 310. The stopper 310 seals the suction channel 136 to prevent secretions from flowing to the distal end of the outer sleeve 102 and out into the lungs. In another embodiment, the suction channel 136 ends at a position distal to the opening 310. For example, the channel 136 is no longer formed between the outer sleeve 102 and the inner sleeve 150, and the inner wall 302b of the outer sleeve 102 is adjacent to the outer wall 308b of the inner sleeve 150.

[0063] Due to the reduced length of the cuff assembly 126, the distal end 126 of the tracheostomy tube 100 between the cuff assembly and the main opening 138 has a length L of at least 10 mm. DE , and the length L of the distal end DE It may be 20 mm or more. At the distal end 126, the inner wall 308a of the inner sleeve 150 includes a plurality of window holes 322, which form part of the secondary airflow opening 128. The plurality of window holes 322 in the inner sleeve 150 are substantially aligned with the plurality of window holes 130 in the outer sleeve 102. For example, when properly aligned, the openings for the window holes 322 on the outer wall 308b of the inner sleeve 150 substantially overlap with the openings for the corresponding window holes 130 on the inner wall 302b of the outer sleeve 102. Substantially overlapping means at least 80% overlap in the area of ​​the openings.

[0064] In an embodiment, each window 322 has a slanted or skewed wall, for example, the wall is at an angle relative to the centerline of the distal end 126. For example, the inner opening of the window 130 is more distal than the outer opening. The angle of the window wall relative to the centerline of the distal end 126 can be between 10 and 45 degrees. This configuration allows the suction catheter to be smoothly introduced into the inner cannula 150 and helps prevent the tip of the suction catheter from getting stuck on the inner opening of the window 130.

[0065] Although the secondary airflow opening 128 is shown as being positioned on a first side of the tracheostomy tube 102, the plurality of fenestrations 322 may be positioned on the opposite side of the tracheostomy tube 102, or on the front side of the tracheostomy tube 102. In addition, a second plurality of fenestrations may be positioned on one or more of the second opposite side, the front side, or the back side. The plurality of fenestrations may be positioned circumferentially around the tracheostomy tube 102 or in other configurations. In addition, the diameter of the fenestrations 322 may be larger or smaller depending on the number of fenestrations 322. The structure of the fenestrations 322 must include sufficient diameters of the individual fenestrations and the number of fenestrations to provide the airflow required for breathing.

[0066] Figure 4 Another cross-sectional view of an exemplary embodiment of a tracheostomy tube 100 is illustrated. The cross-sectional view is taken along Figure 2102 and 106b are shown in FIG. 104 , and illustrate a second inflation line 106b positioned in a second passage 400. The second passage 400 is formed between the inner wall 302b and the outer wall 302a on the front side of the outer sleeve 102. The second passage 400 extends from the proximal side of the flange 108 at the hub 110 of the outer sleeve 102 to at least the sleeve assembly 102. The second inflation line 106b is located within the second passage 400. The distal end 406 of the inflation tube 106b extends through the sealed opening 404 in the outer wall 402b of the outer sleeve 102 into the outer bladder 122. Thus, the inflation tube 106b forms an airtight fluid connection for inflation of the outer bladder 122.

[0067] In this embodiment, two channels 300, 400 for holding the inflation lines 106a, 106b are formed in the front wall of the outer sleeve 102. In another embodiment, the two channels 300, 400 can be formed in the side wall of the outer sleeve 102. In yet another embodiment, a single channel can accommodate both inflation lines 106a, 106b. In yet another embodiment, the channels 300, 400 can be formed between the inner sleeve 150 and the outer sleeve 102, for example, on the front side of the tracheostomy tube 100. Other implementations can also be used to position the inflation lines 106a, 106b from the proximal side of the flange 108 to the cuff assembly 120 of the tracheostomy tube 100.

[0068] Figure 5A An exemplary embodiment of an inner sleeve 150 of a tracheostomy tube 100 is illustrated. The inner sleeve 150 is internally fitted to the outer sleeve 102 and is removable for replacement and / or cleaning. Like the outer sleeve 102, the inner sleeve 102 includes a distal section 508, a proximal section 504, and an intermediate section 506 connected between the proximal section 504 and the distal section 508. The intermediate section 506 is curved so that the proximal section 504 is at an angle of about 80 degrees to about 90 degrees relative to the distal section 508. The distal section 508 includes the main distal opening 138 of the tracheostomy tube 100.

[0069] In this embodiment, the suction channel 136 is formed between the inner walls of the outer sleeve. The inner sleeve 150 includes a rear outer wall recess 510 configured to form an upper portion of the suction channel 136. The recess 510 is sized to fit the upper portion of the suction conduit 134.

[0070] In an embodiment, each window aperture 322 on the inner sleeve 102 has inclined or skewed walls, for example, the walls are at an angle relative to the centerline of the distal segment 508. For example, the opening of the window aperture 322 on the inner wall 308a is more distal than the opening of the window aperture 322 on the outer wall 308b. The angle of the window aperture wall relative to the centerline of the distal segment 508 can be between about 10 degrees and about 45 degrees. This configuration allows the suction catheter to be smoothly introduced into the inner sleeve 150 and helps prevent the tip of the suction catheter from getting stuck on the inner opening of the window aperture 322.

[0071] Figure 5B A side view of another exemplary embodiment of a secondary airflow opening 128 of a tracheostomy tube 100 is illustrated. In another embodiment, to avoid the need to align the fenestrations, the inner sleeve 150 includes a plurality of fenestrations 322, and the outer sleeve 102 forms a larger side opening 520 that exposes the plurality of fenestrations 130 on the inner sleeve 150. The side opening 522 substantially covers the area above the plurality of fenestrations 322 on the inner sleeve 150. For example, the opening 522 exposes at least 90% of the plurality of fenestrations 322 on the inner sleeve 150 or a total area of ​​at least about 20 square millimeters to about 80 square millimeters of the fenestrations 322 to provide adequate airflow or other fenestration area required to provide adequate airflow to the patient.

[0072] Figure 5C A side view of another exemplary embodiment of the secondary airflow opening 128 of the tracheostomy tube 100 is illustrated. In another embodiment, instead of a plurality of fenestrations, a plurality of slits 524 may be provided for the secondary airflow opening 128. In this embodiment, the inner sleeve 150 forms a plurality of slits 524, and the outer sleeve 102 forms a side opening 520 that substantially exposes the plurality of slits 524 on the inner sleeve 150. The opening 522 substantially covers the area above the plurality of slits 524 on the inner sleeve 150. In another embodiment, the outer sleeve 102 may also include a plurality of slits that are aligned with the plurality of slits 524 in the inner sleeve 150. The plurality of slits 524 may each have an inclined or skewed wall. For example, the inner opening of the slit 524 is more distal than the outer opening of the slit 524.

[0073] Thus, the secondary airflow openings 128 may include a plurality of fenestrations, slits, or other shaped openings formed in the inner sleeve 150 and / or the outer sleeve 102. For example, the outer sleeve 102 may form a plurality of openings that are substantially aligned with the plurality of openings formed in the inner sleeve 102. In another example, the outer sleeve 102 may form at least one larger opening that substantially exposes the plurality of openings formed in the inner sleeve 102. Other configurations may be implemented so that the area of ​​the individual openings and the number of openings produce sufficient airflow for the patient.

[0074] Second embodiment of the sleeve system

[0075] Figure 6 A perspective view of another exemplary embodiment of a tracheostomy tube 100 is illustrated having a second exemplary embodiment of a cuff system 120. In this embodiment, the tracheostomy tube 100 does not include an inner cannula 150. For example, the inner cannula 150 may be removed or not inserted with the outer cannula 102. In another example, some tracheostomy tubes 100 are not designed to include an inner cannula 150.

[0076] At the proximal section of the tracheostomy tube 100, the flange 108 in this embodiment includes two opposing wings extending from the hub 110. The top 602 of the tracheostomy tube 100 is attached to the ventilator. At the distal section, a primary distal opening 138 is formed between the distal bottom surface 140 of the wall 132 of the outer sleeve 102. The tracheostomy tube 100 also includes a secondary airflow opening 128 on the side of the outer sleeve 102 between the cuff assembly 120 and the primary distal opening 138. The secondary airflow opening 128 includes a plurality of fenestrations 130.

[0077] and Figure 1 Similarly, sleeve assembly 120 includes inner sleeve 124 and outer bladder 122. Inner sleeve 124 and outer bladder 122 have a more cylindrical shape, and in this example, inner sleeve 124 has a shorter length than outer bladder 122. For example, the length L of outer bladder 122 is OB is about 6 mm, and the length L of the inner sleeve 124 IC The outer bladder 122 includes a top surface 604 that extends proximally further than the inner sleeve 124 to form a collection container, as described in more detail below.

[0078] The first inflation line 106a includes an inflation balloon 606a connected to a one-way valve for inflation of the inner cuff 124. The second inflation line 106b includes an inflation bladder 606b attached to a one-way valve for inflating the outer bladder 122. Thus, the outer bladder 122 and the inner cuff 124 are configured to inflate and maintain different pressures. The relatively elastic inner cuff is configured to operate in an expanded state at a lower pressure (e.g., in a pressure range of 10 cm H2O to 20 cm H2O). In contrast, the less elastic or relatively inelastic outer bladder is configured to operate in an expanded state at a higher pressure range of 50 cm H2O to 150 cm H2O.

[0079] In use, for example, when inserted into the trachea and subsequently pressurized to an expanded state, the first inner cuff 124 behaves as an HVLP type cuff, while the second outer balloon 122 behaves as an LVHP type cuff. In addition, the outer balloon 122 in the expanded state forms a relatively smooth surface with fewer wrinkles or folds, for example, compared to an LVHP cuff. This reduction in wrinkles reduces the risk of leaks and creates a more uniform tracheal seal. In this way, the cuff assembly 100 utilizes a novel system to titrate tracheal pressure, thereby reducing tracheal complications.

[0080] Embodiments of secretion collection containers

[0081] Mechanically ventilated (MV) patients experience a physiologically altered environment: reduced ability to clear oral and nasal secretions, decreased tracheobronchial mucociliary clearance, increased accumulation of secretions in the lungs and bronchi, reduced cough reflex, and increased likelihood of gastric reflux. The combined effect of all these factors is to predispose MV patients to ventilator-associated pneumonia (VAP), a lung infection that develops in patients, typically after 48 hours of mechanical ventilation.

[0082] The accumulation of secretions above the tracheostomy cuff in MV patients is a normal physiological phenomenon. The sources of secretions are the mouth, sinuses, and stomach ("orogastric secretions"). It is known that under normal conditions, the mouth and sinuses produce up to 3 liters of secretions per day. Again, this does not include gastric refluxate, which may be an important factor. While healthy people are able to eliminate and / or control secretions, ventilated patients are not. Instead, in ventilated patients, secretions in the trachea accumulate proximal to the tracheostomy cuff or leak through the tracheostomy cuff and into the trachea and lungs.

[0083] The problem with secretions accumulating above the tracheostomy cuff is that the secretions are loaded with microorganisms, including bacteria and fungi. Since secretions are highly contaminated, they should be kept away from the sterile organs of the human body. The lungs are one of those sterile organs. Therefore, it becomes essential for the treating physician to prevent secretions from leaking into the patient's lungs.

[0084] The tracheostomy cuff can be a powerful suction prevention mechanism. When inflated, the tracheostomy cuff contacts the tracheal wall circumferentially, thereby creating a seal to prevent fluid from leaking into the lungs. One strategy to combat VAP is to enhance the closure function of the tracheostomy cuff, such as improving the sealing ability of the tracheostomy cuff, thereby reducing secretions that leak into the lungs, as discussed herein using the cuff assembly 120. Although this strategy is helpful, if secretions are allowed to accumulate proximally of the tracheostomy cuff, the sheer pressure of the secretions will eventually likely cause secretions to leak into the lungs. Therefore, in addition to effective tracheal occlusion, an effective method for clearing secretions is also needed.

[0085] Current systems for clearing secretions include a suction tube at the proximal end of a tracheostomy sleeve. However, the known configuration of the suction tube opening can cause direct damage to the tracheal mucosa and aspiration trauma. The suction tube opening is configured so that it is easily blocked by the sleeve wall. In addition, due to its small size, the suction tube is easily occluded. A larger suction tube may significantly increase the volume of the tracheostomy tube, enough to make the intubation process more difficult. In addition, when the suction tube is integrated into the tracheostomy tube and the suction tube is occluded, the entire tracheostomy tube and sleeve must be replaced. Therefore, there is a need for an improved secretion clearing system.

[0086] Figure 7 A second side perspective view of an exemplary embodiment of a tracheostomy tube 100 having a second exemplary embodiment of a cuff system 120 is illustrated. In this cuff assembly 120, the top surface 604 of the outer bladder 122 extends proximally further than the inner cuff 124 to form a secretion collection container 700. The collection container 700 collects aspirate or other fluid that may accumulate around the proximal end of the cuff assembly 100.

[0087] The suction catheter 702 is positioned in a catheter channel 704 that extends from the proximal end of the tracheostomy tube 100 to at least the container 700. The suction catheter 702 is preferably a thin-walled, non-collapsible and flexible hollow channel or tube. In an embodiment, the suction catheter 702 includes a position indicator 706 that provides an indication of the correct positioning of the suction catheter 702 in the catheter channel 704. The position indicator 706 may include a mark or a raised ridge as a guide that prevents the suction catheter 702 from being further inserted into the catheter channel 704.

[0088] The suction catheter 702 is configured to empty the collection container 700 through an opening on the rear side of the tracheostomy tube 102. When the patient is in a prone position, such as is typical for intubated patients, secretions will tend to accumulate on the rear side of the trachea. Therefore, the suction catheter 702 will be more likely to discharge the accumulated secretions through the rear opening in the container 700. The proximal end of the suction catheter 702 is configured to be connected to a syringe for flushing or to a vacuum source using a suction tube. When connected, the vacuum source can be operated continuously or periodically to clear the secretions in the container 700. When the suction catheter 702 becomes occluded, an alarm can be triggered.

[0089] In the event of an occlusion, the suction catheter 702 can be removed from the catheter channel 704 and replaced with a new suction catheter. Thus, the secretion removal system provides an easier method of replacing the suction catheter 702 in the event of an obstruction than the current method of replacing the entire tracheostomy tube. The secretion container 700 also helps protect the tracheal wall from suction trauma or direct injury to the tracheal mucosa by the suction catheter 702. The secretion container 700 also helps prevent the cuff 120 from being sucked into the catheter 702. In addition, due to the placement of the catheter channel 704, a larger diameter suction catheter 702 can be used, which reduces the chance of occlusion.

[0090] Figure 8 A cross-sectional view of an exemplary embodiment of a tracheostomy tube 100 having a second exemplary embodiment of a sleeve system 120 is illustrated. In this sleeve assembly 120, the top 604 of the outer bladder 122 extends further proximally than the inner sleeve 124. The top 604 can include an inclined inner surface that slopes toward the proximal surface 820 of the inner sleeve 124. The bottom surface of the collection container 700 is defined by the proximal surface 820 of the inner sleeve 124, which can be reinforced with a harder, less resilient material than the rest of the inner sleeve 124. Thus, the top surface 820 of the inner sleeve and the top 604 of the outer bladder form the collection container 700.

[0091] The catheter channel 704 extends from the proximal end of the tracheostomy tube 100 to at least the collection container 700. The catheter channel 704 is formed by an inner wall 804 located within the tracheostomy tube 100 and an outer wall 806 of the tracheostomy tube 100. In this embodiment, the catheter channel 704 is positioned on the rear side of the tracheostomy tube 100 and is configured to cooperate with the suction catheter 702. For example, the suction catheter 702 can have an outer diameter of about 4 mm. Then, the suction channel 704 has an inner diameter greater than 4 mm, such as about 4.1 mm to about 4.5 mm, so that the suction catheter 702 can slide through the catheter channel 704 during removal and / or insertion.

[0092] A rear opening 802 from the catheter passage 704 to the container 700 is formed in the outer wall 806 on the rear side of the tracheostomy tube 100. The distal end of the suction catheter 702 can extend through the rear opening 802 into the container 700. The catheter passage 704 can include an inclined surface 814, for example, formed by the inner wall 804, at the distal end adjacent to the opening 802. The inclined surface 814 helps guide and position the distal end of the catheter 702 through the opening 802. Thus, the suction catheter 702 can drain fluid from the container 700 and help prevent fluid from leaking into the patient's lungs.

[0093] The inflation line 106a is positioned from the proximal end of the tracheostomy tube 100 to the inner cuff 124. The inflation line 106a can be attached to the inner wall of the tracheostomy tube 100 using an adhesive or other means, or positioned in a designated channel. An opening 812 is formed in the outer wall 806 of the tracheostomy tube 100 for the distal end 810 of the inflation line 106a to access the inner cuff 124. A similar configuration can be implemented for the inflation line 106b to access the outer balloon 122.

[0094] 9A to 9C A block diagram illustrating a cross-sectional view of an embodiment of a sleeve system 120 is shown. Fig.9A , which illustrates a sleeve system 120 including an inner sleeve 124 and an outer bladder 122. The outer bladder 122 is a separate structure, for example, having a wall separate from the inner sleeve 124. The outer bladder 122 includes an inner surface 902a and an outer surface 902b. The inner surface 902a of the outer bladder 122 is positioned adjacent to the outer surface 904b of the inner sleeve 124 and can be attached to the outer surface 904b of the inner sleeve 124 using, for example, one or more adhesives, heat, or other means. The inner surface 904a of the inner sleeve 124 is adjacent to and connected to the outer sleeve 102 of the tracheostomy tube 100. The inner surface 902a of the outer bladder 122 is close to and / or attached to the outer surface 904b of the inner sleeve 124, for example, using adhesives or heat or other means. Additionally or alternatively, a band 808 can be attached to the tracheostomy tube 102 and extend at least to the inner sleeve 124. The strap 808 may also be attached to the outer bladder 122 .

[0095] In this embodiment of the sleeve assembly 120, the length L of the outer bladder 122 is OB And the length L of the inner sleeve 124 IC For example, when inflated, the length L of the inner sleeve 124 is IC is about 15 mm, and the length L of the outer bag 122 (excluding the top 604) is OB In another embodiment, the length L of the outer bag 122 is about 15 mm. OB And the length L of the inner sleeve 124 IC For example, the length L of the outer bag (together with the top 604) OB The length L of the inner sleeve 124 may be about 15 mm. IC In addition, in an embodiment, the width W of the outer capsule is about 6 mm. OB and the inner sleeve width W IC For example, the width W of the outer capsule OB and the inner sleeve width W IC In other embodiments, the width W of the outer capsule is about 6 mm. OB Or the width of the inner sleeve W ICIt may be different, for example, the inner sleeve 104 may be wider or narrower than the outer bladder 106. The inner sleeve 104 and the outer bladder 106 may have a thickness of about 0.00086 inches (0.022 mm) or less. These dimensions are exemplary, and the sleeve assembly 120 may be implemented with other dimensions.

[0096] To form the collection container 700, the top 604 of the outer bag 122 extends proximally from the inner sleeve 124 and is tilted inward to form a groove. The length of the top 604 from the proximal surface 820 of the inner sleeve 124 can range between about 2 mm and about 15 mm. The container 700 can span about 90 degrees to about 180 degrees on the back side of the sleeve assembly 120, or span 360 degrees around the circumference of the tracheostomy tube 100. The top 604 is attached to the proximal surface 820 of the inner sleeve 124 and / or the tracheostomy tube 100. This prevents leakage between the inner sleeve 124 and the outer bag 122. The top 604 of the outer sleeve 122 can include a hard PVC sheet to oppose and seal the tracheal wall and allow secretions to flow into the well. The hard PVC sheet also helps prevent leakage of secretions.

[0097] Alternatively or additionally, the inner sleeve 124 can be attached to form a seal to prevent leakage or be pressed against the outer bladder 122, such as so that secretions or other substances cannot leak through the joint. For example, the inner sleeve 124 and the outer bladder 122 can be attached adhesively or using a heat process or a combination thereof to form a seal to prevent leakage.

[0098] In addition, the inner surface 904a of the inner sleeve 124 is sealed or attached to or pressed against the outer wall 806 of the tracheostomy tube 100 to prevent leakage. For example, the inner sleeve 124 and the tracheostomy tube 100 can be adhesively attached, or attached using a thermal process, or a combination thereof. The seal or attachment prevents secretions between the tracheostomy tube 100 and the inner sleeve 124 from leaking.

[0099] Fig. 9C Another embodiment of the sleeve system 120 is illustrated in which a separate structure 910 is attached to the tracheostomy tube to form the secretion collection container 700. The structure 910 is located proximal to the sleeve assembly 120 and is attached to the tracheostomy tube 100. Alternatively or additionally, the structure 920 may be attached to the top proximal surface of the inner sleeve 102 and / or the top proximal surface of the outer balloon.

[0100] 9A to 9C The configuration shown in is exemplary, and other configurations for forming the collection container 700 may be implemented.

[0101] Implementation of the pressure regulation system

[0102] Compared to the tube itself, the benefits and risks of the tracheostomy tube rely on maintaining a predetermined pressure range in the sleeve assembly 120. For example, overinflation of the sleeve assembly 120 may cause damage to the tracheal mucosa, resulting in ischemic injury and vocal cord nerve damage. The damage is due to the constant pressure applied by the sleeve to prevent blood from flowing to the tracheal mucosa. This blood loss may cause tissue necrosis. In addition, damage may also occur due to repeated wear and tear from the sleeve moving on the tracheal wall. When the sleeve assembly 120 is underinflated and the tracheal seal is not sufficient, the patient may not receive enough oxygen. In addition, the patient has an increased likelihood of pneumonia due to aspiration of orogastric contents. Therefore, maintaining the pressure of the sleeve assembly 120 of the tracheostomy tube 100 is a key part of patient care, reducing tracheal damage and preventing ventilator-associated pneumonia (VAP).

[0103] Currently, several types of automatic cuff pressure adjusters are available. These current devices monitor intra-cuff pressure within a single cuff. However, a closer inspection reveals a major flaw in this approach. The intra-cuff pressure does not reflect the precise pressure applied to the tracheal wall. Ultimately, it is the tracheal wall pressure that determines the risks and benefits of the cuff. Therefore, there is a need for an improved system and method to monitor and adjust cuff pressure.

[0104] Fig.10 A block diagram of an embodiment of a tracheostomy tube 100 having a plurality of pressure sensors 1000 is illustrated. A first pressure sensor 1000a may be positioned within the inner cuff 124, or alternatively, at the proximal end of its air tube (not shown), to measure the air pressure within the inner cuff 124. A second pressure sensor 1000b is positioned within the outer bladder 122, or alternatively at the proximal end of its air tube (not shown), to measure the air pressure within the outer bladder. One or more pressure sensors 1000c, 1000d may be positioned on the outer surface of the outer bladder 122 to measure the pressure applied by the cuff assembly to the tracheal wall ("tracheal pressure"). Alternatively or additionally, a pressure sensor 1000e may be positioned between the outer bladder 122 and the inner cuff 124t to measure tracheal pressure.

[0105] The pressure adjustment system monitors tracheal pressure by utilizing one or more pressure sensors 1000c, 1000d on the surface of the outer balloon and / or a pressure sensor 1000e between the inner cuff 124 and the outer balloon 122. For example, the force of the inner cuff 124 acts radially on the outer balloon 122 and is therefore the force that is ultimately applied to the tracheal wall as tracheal pressure. Since the inner cuff pressure sensor 1000e is located between the inner cuff 124 and the outer balloon 122, it measures the radial force of the inner cuff 124 acting on the outer balloon 122. In this way, the pressure sensor 1000e measures tracheal pressure, such as the pressure applied by the cuff assembly 102 on the tracheal wall.

[0106] The pressure sensor 1000 transmits the pressure measurement result to the pressure regulation system. The pressure sensor 1000 may include a wireless transmitter, such as a near field or radio frequency identification (RFID) transmitter or an Internet of Things (IoT) cellular transmitter. The pressure sensor can then use the wireless transmitter to wirelessly transmit the pressure measurement result to the pressure regulation system.

[0107] Additional pressure sensor devices may be positioned within the tracheostomy tube 100 or at the tip of the tracheostomy tube 100 to measure the pressure of the oxygenated air delivered to the patient.

[0108] Fig.11 A schematic block diagram of an exemplary embodiment of a pressure regulator and control system ("regulator system") 1000 for a cuff assembly 120 is illustrated. The regulator system 1000 is in fluid communication with the cuff assembly 120 and inflates the cuff assembly 120 and regulates the pressure within the cuff assembly 120, such as when the tracheostomy tube 100 is implanted in the trachea of ​​a patient. The pressures of the inner cuff 124 and outer bladder 122 of the cuff assembly 120 are monitored and controlled separately.

[0109] The regulator system 1000 includes a pressure controller 1108 and a pneumatic system 1120. The pressure controller 1108 includes a processor device 1110 and a memory device 1112. The memory device 1112 includes one or more non-transitory processor-readable memories storing instructions that, when executed by the processor device 1110 or other components of the regulator system 1000, cause the regulator system 1000 to implement one or more functions described herein. The processor device 1110 includes at least one processing circuit, such as a microprocessor, a microcontroller, a digital signal processor, a microcomputer, a central processing unit, a field programmable gate array, a programmable logic device, a state machine, a logic circuit, an analog circuit, a digital circuit, and / or any device that manipulates signals (analog and / or digital) based on hard coding of circuits and / or operating instructions. The memory device 1112 includes a non-transitory memory device and can be an internal memory or an external memory, and can be a single memory device or a plurality of memory devices. The memory device 1112 may be a read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, and / or any non-transitory memory device that stores digital information.

[0110] The pressure controller 1108 can be co-located in the same physical device as the pneumatic system 1120, or in separate devices or housings. The pressure controller 1108 also includes a user interface 1114. The user interface 1114 generates user input and output (I / O) and includes one or more of a display, keyboard, touch screen, mouse, touch pad, gauges, switches, or other I / O devices.

[0111] In use, the pressure controller 1108 determines a desired predetermined pressure setting for the sleeve assembly 120 in response to user input received by the user interface 1114. Alternatively, a default pressure setting may be implemented, for example in the absence of user input.

[0112] Different pressure settings may be set for the inner cuff 124 and the outer bladder 122. The pressure setting may be a predetermined pressure or pressure range, such as typically within plus or minus 2 cm H2O. For example, the pressure setting for the inner cuff 124 may be a pressure within a range of 10 cm H2O to 20 cm H2O (plus or minus 2 cm H2O). Conversely, the pressure setting for the outer inflatable bladder may be a pressure within a range of 50 cm H2O to 150 cm H2O (plus or minus 2 cm H2O). Thus, the inner cuff 124 operates within a pressure range that is lower than the operating pressure range of the outer bladder 122. The pressure controller 1108 also determines the frequency with which the pressure of the cuff assembly 120 is measured and adjusted, such as by user input or a default setting.

[0113] The pneumatic system 1120 includes a first pneumatic path for the outer bag 122, which includes, for example, a first air pump 1122a and a release valve 1124a, which is fluidly coupled to the outer bag 122 through, for example, an output port 1126a, a one-way valve, a sight balloon, and an inflation line 106b. The pneumatic system 820 also includes a different second pneumatic path for the inner cuff 124, which includes a second air pump 1222b and a release valve 1224b, which is fluidly coupled to the inner cuff 124 through, for example, an output port 1226b, a one-way valve, a sight balloon, and an inflation line 106a. Although two air pumps 1222a, 1222b are described herein, a single air pump can supply pressurized air to the inner cuff 124 and the outer bag 122, for example, using a valve or switch between the two fluid paths.

[0114] The pneumatic system 1220 thus includes separate pneumatic pathways to fluidly increase or decrease the pressure in the air cuff 104 and the outer bladder 122 independently and separately.

[0115] In operation, the pressure controller 1108 receives pressure measurements from one or more pressure sensor devices 1000 to adjust the pressure of the cuff assembly 120. For example, the cuff pressure sensor device 1000e is positioned between the inner cuff 124 and the outer bladder 122 and measures the radial force of the inner cuff 124 on the outer bladder 122. The inner cuff pressure sensor device 1000a can be positioned within the inner cuff 124 to measure the pressure within the inner cuff 124. The outer bladder pressure sensor device 1000b can be positioned to measure the pressure within the outer bladder 122. Additional outer cuff assembly pressure sensor devices 1000c / 1000d can be positioned on the outer surface of the outer bladder 122 to measure tracheal pressure. Additional pressure sensor devices can also be implemented. The pressure sensor devices generate pressure measurements and transmit them to the pressure controller 1108, for example, via wired leads and / or wireless transmitters.

[0116] The pressure regulator system 1100 includes a pressure feedback loop in which a pressure controller 1108 controls a pneumatic system 1120 to adjust the pressure of both the inner cuff 124 and the outer bladder 122 in response to pressure measurements. The pressures of the inner cuff 124 and the outer bladder 122 are monitored and controlled separately. The pressure controller 1108 sends a signal to the pneumatic system 1120 to add or release air to the outer bladder 124 and / or the inner cuff 122. For example, to adjust the pressure in the outer bladder 122, the pressure controller 1108 may signal the air pump 1122a to add air to the outer bladder 122, or to signal the release valve 1124a to release air from the outer bladder 122. In another example, to adjust the pressure in the inner cuff 124, the pressure controller 1108 may signal the air pump 1122b to add air to the inner cuff 124, or to signal the release valve 1124b to release air from the inner cuff 124.

[0117] The regulator system 800 monitors the pressure measurements and automatically adjusts the pressure, firstly adjusting the pressure of the outer bladder 122 and secondly adjusting the pressure of the inner cuff 124, to achieve a predetermined pressure setting, such as pre-selected by an operator or by default. The pressure controller 1108 may continuously monitor and adjust the pressure of the cuff assembly 120, or may monitor and adjust the pressure at predetermined time intervals. The regulator system 1100 may also include a visual and / or audible alarm in the event of an unsafe pressure measurement.

[0118] Fig.12A flow chart illustrating an embodiment of one or more methods 1200 for monitoring and controlling the pressure of the cuff assembly 120 is illustrated. At step 1202, one or more pressure measurements related to tracheal wall pressure are obtained by the regulator system 1100 from one or more pressure sensor devices 1000. At step 1204, using these pressure measurements, the regulator system 1100 determines whether the tracheal pressure (e.g., the pressure exerted on the tracheal wall by the cuff assembly 120) is within a predetermined pressure range. The pressure measurements can come from the intercuff pressure sensor device 1000e between the inner cuff 124 and the outer bladder 122 and / or from one or more pressure sensors 1000c to 1000d located on the outer surface of the outer bladder 122. When the tracheal pressure exceeds the predetermined pressure range, at step 1106, the regulator system 1100 reduces the pressure in at least the inner cuff 124. For example, the regulator system 1100 can control the release valve 1124b to release air from the inner cuff 124. Because tracheal mucosal blood flow may be compromised when applied pressure is above 30 cm H2O (22 mmHg), the regulator system 1100 may reduce the pressure of at least the inner cuff 124 when the measured tracheal pressure exceeds 30 cm H2O (22 mmHg).

[0119] When the tracheal pressure is below the predetermined pressure range, the regulator system 1100 increases the pressure in at least the inner cuff 124 at step 1206. For example, the regulator system 1100 may control the air pump 1122b to pump air into the inner cuff 124. In addition, the pressure of the outer bladder 122 may also be adjusted. These steps may be performed at preset time intervals or continuously.

[0120] At step 1208, one or more pressure measurements related to the outer bladder pressure are obtained from one or more pressure sensor devices by the regulator system 1000. At step 1210, the regulator system 1100 determines whether the pressure of the outer bladder 122 is within a predetermined pressure range using these pressure measurements. For example, the pressure measurements may come from a pressure sensor device 1000b located within the outer bladder 122 or at a sight balloon of an inflation line 106b for the outer bladder 122. When the outer bladder pressure is less than or greater than the predetermined pressure range, at step 1212, the regulator system 1100 increases or decreases the pressure in the outer bladder 122. For example, the regulator system 800 may control the air pump 1122a to pump air into the outer bladder 122 when its pressure is below the predetermined pressure range, or control the release valve 1124a to release air from the outer bladder 122 when its pressure is above the predetermined pressure range.

[0121] At step 1214, the regulator system 1100 obtains one or more pressure measurements related to the inner cuff pressure from one or more pressure sensor devices. At step 1216, the regulator system 1100 determines whether the pressure of the inner cuff 124 is within a predetermined pressure range using these pressure measurements. For example, the pressure measurements may come from a pressure sensor device 1000a located within the inner cuff 124 or at a sight balloon of an inflation line 106a for the inner cuff 124. When the inner cuff pressure is less than or greater than the predetermined pressure range, at step 1218, the regulator system 1100 may increase or decrease the pressure in the inner cuff 124. For example, the regulator system 1100 may control the air pump 1122b to pump air into the inner cuff 124 when the pressure of the inner cuff 124 is below the predetermined pressure range, or control the release valve 1124b to release air from the inner cuff 124 when the pressure of the inner cuff 124 is above the predetermined pressure range. The inner cuff is a low pressure inflatable cuff and may have a predetermined pressure range of 10 cm H2O to 20 cm H2O.

[0122] The pressure of the inner cuff 124 and outer bladder 122 of the cuff assembly 120 is thus controlled separately using separate pneumatic pathways (e.g., separate air pumps 1122 and / or release valves 1124 and separate air inflation tubes 106a, 106b). The pressure of the less elastic outer bladder 122 is maintained at a higher pressure than the pressure of the more highly elastic inner cuff. The pressure controller 1110 can also independently adjust the pressure of the inner cuff 124 or outer bladder 122 to adjust the tracheal pressure.

[0123] Thus, the sleeve assembly 120 and adjuster system 1100 help reduce microaspiration and lung infection by maintaining a good seal with the tracheal wall, but without unduly damaging the tracheal wall. The system provides an improved airway seal with minimal damage to the airway.

[0124] The tracheostomy tube 100 described herein includes a novel secondary airflow opening 128 for reducing the risk of occlusion, an improved sleeve assembly 120, and an effective secretion collection and removal system. The sleeve assembly 120 includes an annular outer balloon 122 and an inner sleeve 124. The inner sleeve is made of a relatively elastic material and operates at a relatively low pressure. The outer balloon 122 includes a relatively less elastic material and operates at a higher pressure to achieve full inflation, thereby obtaining an optimal tracheal seal.

[0125] The outer bladder 122 may also be configured to form a collection container 700 at the upper portion of the sleeve system 120. The accumulated body secretions are then drained from the container 700 through the suction channel.

[0126] The novel sleeve system 120 disclosed herein can also make the length of the sleeve significantly shorter than the current tracheostomy sleeve. In the case of a shorter sleeve length, sufficient space can be obtained in the distal section of the tracheostomy tube 100 to create a secondary airflow opening 128 on the side wall of the distal side of the tracheostomy tube 100. When the main opening 138 of the tracheostomy tube 100 becomes occluded, the secondary airflow opening 128 provides an alternative way for breathing. In the absence of the secondary airflow opening 128, occlusion of the tracheostomy tube 100 may lead to death. The tracheostomy tube 100 with the secondary airflow opening 128 disclosed herein, the improved sleeve assembly 120 and the effective secretion discharge system represents a significant improvement in the safety and health of the patient.

[0127] As used herein, the term "operably" or "configurably" represents that an element includes one or more of a component, size, circuit, instruction, module, data, input, output, etc., to perform one or more of the described or necessary corresponding functions, and may also include an inference connection with one or more other items to perform the described or necessary corresponding functions. As may also be used herein, the term "connection", "connected to", "connected to" and / or "connection" or "interconnection" includes a direct connection or link between components or between nodes / equipment and / or an indirect connection between components or nodes / equipment via an intermediate item. As may be further used herein, the inferred connection (that is, one of the elements is connected to another element by inference) includes a direct and indirect connection between two items in the same manner as "connected to". As used herein, the terms "substantially" and "approximately" provide an industrially acceptable tolerance for the relativity between its corresponding terms and / or items.

[0128] Note that various aspects of the present disclosure may be described herein as processes depicted as schematic diagrams, flow charts, flow diagrams, structure diagrams, or block diagrams. Although a flow chart may describe an operation as a sequential process, many operations may be performed in parallel or simultaneously. In addition, the order of the operations may be rearranged. When the operations of a process are completed, the process terminates. A process may correspond to a method, function, process, subroutine, subprogram, etc. When a process corresponds to a function, its termination corresponds to returning the function to a calling function or a main function.

[0129] The various features of the present disclosure described herein may be implemented in different systems and devices without departing from the present disclosure. It should be noted that the foregoing aspects of the present disclosure are merely examples and should not be construed as limiting the present disclosure. The description of the various aspects of the present disclosure is intended to be illustrative rather than limiting the scope of the claims. Similarly, the present invention may be easily applied to other types of devices, and many substitutions, modifications, and variations will be apparent to those skilled in the art.

[0130] In the foregoing description, certain representative aspects have been described with reference to specific embodiments. However, various modifications and changes may be made without departing from the scope of the invention as set forth in the claims. The description and drawings are illustrative rather than restrictive, and modifications are intended to be included within the scope of the claims. Therefore, the scope of the claims should be determined by the description herein and its legal equivalents, rather than merely by the examples described. For example, the components and / or elements described in any device claim may be assembled or otherwise operably configured in various arrangements, and are therefore not limited to the specific configurations described in the claims.

[0131] Furthermore, certain benefits, other advantages, and solutions to problems have been described above with respect to particular embodiments; however, any benefit, advantage, solution to problems, or any element that may cause any particular benefit, advantage, or solution to occur or become more significant should not be construed as a critical, required, or essential feature or component of any or all the claims.

[0132] As used herein, the words "comprises," "comprising," "having," "containing," or any variation thereof, are intended to represent non-exclusive inclusion, such that a process, method, article, composition, or apparatus comprising a list of elements includes not only those elements listed, but may also include other elements not expressly listed or inherent to such processes, methods, articles, compositions, or apparatuses. Other combinations and / or modifications of the above-described structures, arrangements, applications, proportions, elements, materials, or components used in the practice of the present invention, except those not specifically described, may be varied or otherwise specifically adapted to specific environments, manufacturing specifications, design parameters, or other operating requirements without departing from the general principles of the present invention.

[0133] In addition, unless otherwise specified, referring to an element in the singular does not mean "one and only one", but rather "one or more". Unless otherwise explicitly stated, the term "some" refers to one or more. All structural and functional equivalents of the elements of the various aspects described throughout this disclosure are known or will be known to those of ordinary skill in the art, and these equivalents are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly stated in the claims. Under 35 U.S.C. §112(f), no claim element is intended to be interpreted as a "means plus function" type element unless the element is explicitly stated using the phrase "means for..." or, in the case of a method claim, the phrase "step for..." is used to state the element.

Claims

1. A tracheostomy tube, comprising: an outer sleeve of the tracheostomy tube, the outer sleeve comprising a distal section, wherein the distal section comprises a main distal opening; The sleeve assembly of the tracheostomy tube, the sleeve assembly is at the distal section of the outer sleeve, and the sleeve assembly comprises: an inflatable inner sleeve having an inner surface and an outer surface, wherein the inner surface is positioned adjacent to the outer sleeve, and wherein the inner sleeve has a first elasticity; and an inflatable outer bladder positioned adjacent the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity that is less than the first elasticity of the inner sleeve; and wherein the distal section of the outer sleeve of the tracheostomy tube forms a secondary airflow opening located between the sleeve assembly and the primary distal opening, wherein the secondary airflow opening located between the sleeve assembly and the primary distal opening of the tracheostomy tube has a sufficient total area to maintain airflow for patient breathing and is configured to remain open and serve as a conduit for the flow of both inspired air and expired air during ventilation.

2. The tracheostomy tube according to claim 1, wherein: The length L of the sleeve assembly CA The secondary airflow opening is formed on the side wall of the distal section of the outer sleeve between the sleeve assembly and the primary distal opening and has a total area of ​​at least 20 square millimeters.

3. The tracheostomy tube according to claim 1, wherein: The secondary airflow openings include a plurality of openings formed on the sidewall of the distal section of the outer sleeve between the sleeve assembly and the primary distal opening.

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

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

6. The tracheostomy tube of claim 1, further comprising: An inner sleeve is positioned inside the outer sleeve, wherein the inner sleeve forms a first plurality of openings.

7. The tracheostomy tube according to claim 6, wherein: The secondary airflow opening formed in the outer sleeve includes: At least one opening of the plurality of openings formed in the inner sleeve is substantially exposed.

8. The tracheostomy tube according to claim 6, wherein: The secondary airflow opening formed in the outer sleeve includes: A second plurality of openings formed in the outer sleeve are generally aligned with the first plurality of openings formed in the inner sleeve.

9. The tracheostomy tube of claim 1, further comprising: A suction channel is formed inside the tracheostomy tube, the suction channel including a distal end proximal to the proximal side of the sleeve assembly and a proximal end of the suction channel at the proximal end of the tracheostomy tube, wherein the proximal end of the suction channel is in fluid communication with a vacuum device.

10. The tracheostomy tube of claim 1, further comprising: A pressure regulator, the pressure regulator being configured to: regulating a first pressure in the inner cuff using a first pneumatic path, wherein the first pressure is within a first pressure range of 10 cm H2O to 20 cmH2O; and A second pressure within the outer bag is adjusted using a second, different pneumatic path, wherein the second pressure is within a second pressure range of 50 cm H2O to 150 cm H2O.

11. A tracheostomy tube, comprising: The sleeve assembly of the tracheostomy tube, wherein the sleeve assembly has a length of no more than 20 mm, and the sleeve assembly comprises: an inflatable inner sleeve having an inner surface and an outer surface; and an inflatable outer bladder positioned adjacent to the outer surface of the inner sleeve, wherein the outer bladder has a second elasticity less than the first elasticity of the inner sleeve; an outer sleeve of the tracheostomy tube, the outer sleeve comprising a distal main opening, wherein an inner surface of the sleeve assembly is positioned adjacent to the outer sleeve, and wherein the outer sleeve has a length of at least 10 mm between the sleeve assembly and the distal main opening; and Wherein the outer sleeve forms a secondary airflow opening between the cuff assembly and the primary distal opening, wherein the secondary airflow opening is configured to remain open during ventilation.

12. The tracheostomy tube according to claim 11, wherein The secondary airflow openings are formed on a side wall of the distal section of the outer sleeve between the cuff assembly and the primary distal opening and have a total area of ​​at least 20 square millimeters sufficient to maintain airflow for patient breathing.

13. The tracheostomy tube of claim 11, further comprising: an inner sleeve positioned within the outer sleeve, wherein the inner sleeve forms a first plurality of openings; and Wherein the secondary airflow openings in the outer sleeve include a second plurality of openings, wherein the second plurality of openings in the outer sleeve are substantially aligned with the first plurality of openings in the inner sleeve.

14. The tracheostomy tube of claim 11, further comprising: a first inflation passage formed in a wall of the outer sleeve, wherein the first inflation passage extends from at least one flange of the outer sleeve to the sleeve assembly, and wherein a first inflation line for inflating the inner sleeve is positioned in the first inflation passage; a second inflation passage formed in a wall of the outer sleeve, wherein the second inflation passage extends from at least the flange of the outer sleeve to the cuff assembly, and wherein a second inflation line for inflating the outer bladder is positioned in the second inflation passage; and A pressure regulator system, the force regulator system being configured to: Using the first inflation channel to add or remove air from the inner sleeve to maintain a first pressure range and a first pressure within the inner sleeve; and The second inflation channel is used to add or remove air from the outer bladder to maintain a second pressure range within the outer bladder.

15. The tracheostomy tube according to claim 11, wherein The inner sleeve comprises a relatively elastic material, wherein the relatively elastic material comprises one or more of the following materials: rubber, silicone, latex, polyvinyl chloride (PVC), neoprene, polyisoprene, or polyurethane (PU); and Wherein, the outer bladder comprises a relatively inelastic material, wherein the relatively inelastic material comprises one or more of the following materials: polyethylene terephthalate PETP, low-density polyethylene LDPE, polyvinyl chloride PVC, silicone, neoprene, polyisoprene, or polyurethane PU.

16. The tracheostomy tube of claim 11, wherein: The inner sleeve has a length in the range of 10 mm to 20 mm, and wherein the outer bladder has a length in the range of 5 mm to 9 mm.

17. A tracheostomy tube configured to be fitted within a trachea, the tracheostomy tube comprising: a sleeve assembly, the sleeve assembly comprising at least one inflatable sleeve; an outer sleeve including a distal primary opening, wherein an inner surface of the sleeve assembly is positioned adjacent the outer sleeve, and wherein the outer sleeve forms at least one secondary airflow opening between the sleeve assembly and the primary distal opening; and An inner sleeve is positioned inside the outer sleeve, wherein the inner sleeve forms a first plurality of openings, wherein the at least one secondary airflow opening in the outer sleeve substantially exposes the first plurality of openings in the inner sleeve.

18. A tracheostomy tube according to claim 17, wherein The secondary airflow opening formed in the outer sleeve includes at least one of the following: substantially exposing at least one opening of the plurality of openings formed in the inner sleeve; or A second plurality of openings formed in the outer sleeve are generally aligned with the first plurality of openings formed in the inner sleeve.

19. The tracheostomy tube of claim 17, wherein: The secondary airflow openings are formed in the side wall of the outer sleeve between the cuff assembly and the primary distal opening and have a total area of ​​at least 20 square millimeters sufficient to maintain airflow for patient breathing.

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

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