WO2020197506A1 - Tube endotrachéal et procédé associé - Google Patents

Tube endotrachéal et procédé associé Download PDF

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Publication number
WO2020197506A1
WO2020197506A1 PCT/SG2020/050178 SG2020050178W WO2020197506A1 WO 2020197506 A1 WO2020197506 A1 WO 2020197506A1 SG 2020050178 W SG2020050178 W SG 2020050178W WO 2020197506 A1 WO2020197506 A1 WO 2020197506A1
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
primary
endotracheal tube
tubing
portions
Prior art date
Application number
PCT/SG2020/050178
Other languages
English (en)
Inventor
Chee Mun Eric LOH
Jun Wei NEO
Dotan TROMER
Avshalom SHENHAV
Original Assignee
Avir Medical Pte. Ltd.
Tan Tock Seng Hospital Pte Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Avir Medical Pte. Ltd., Tan Tock Seng Hospital Pte Ltd filed Critical Avir Medical Pte. Ltd.
Publication of WO2020197506A1 publication Critical patent/WO2020197506A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0445—Special cuff forms, e.g. undulated
    • A61M16/0447—Bell, canopy or umbrella shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0454—Redundant cuffs
    • A61M16/0459—Redundant cuffs one cuff behind another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0484—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids at the distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0443—Special cuff-wall materials

Definitions

  • the present disclosure relates to an endotracheal tube.
  • the present disclosure also relates to a method of using the endotracheal tube.
  • the present disclosure also relates to a method of manufacturing the endotracheal tube.
  • An endotracheal tube is a flexible plastic tube that is placed through the mouth into the trachea (i.e. the windpipe). Endotracheal tubes may also be used during surgery with a general anesthetic, or for patients under a trauma or with serious illness. Endotracheal tubes maintain the airway so as to help a patient breathe, and can also be used with a ventilator to deliver a flow of air or other gases to the lungs.
  • VAP ventilator-associated pneumonia
  • an endotracheal tube comprising a tubing insertable into a trachea of an individual, a primary cuff portion and a secondary cuff portion being carried by the tubing and being spaced apart along the tubing, the primary cuff portion being positioned nearer to a machine end of the endotracheal tube, the secondary cuff portion being positioned nearer to a patient end of the endotracheal tube, and wherein the primary and secondary cuff portions are operable to seal against an inner tracheal wall such that the endotracheal tube is lodged within the trachea and a cavity is formed between the first and secondary cuff portions, and wherein at least one of the primary and secondary cuff portions is a concave-shaped cuff operable to collect and retain a fluid therein.
  • the primary cuff portion is the concave-shaped cuff
  • the secondary cuff portion is a convex-shaped cuff.
  • the concave-shaped cuff comprises an opening part for collecting the fluid and a body part for retaining the fluid, the body part comprising one or more support members so as to allow the concave-shaped cuff to maintain its shape.
  • the endotracheal tube further comprises a drainage channel earned by the tubing, wherein the drainage channel is configured to draw the collected and retained fluid out from the trachea.
  • the endotracheal tube further comprises a cuff inflation module operable to inflate the primary and second ary cuff portions to a desired pressure.
  • the cuff inflation module comprises an inflation device; and an inflation channel connected to the inflation device and carried by the tubing, wherein the inflation channel is connected to the primary and secondary cuff portion respectively, and the inflation device is operable to inflate the primary and secondary cuff portions through the inflation channel.
  • the endotracheal tube further comprises an inter-cuff negative pressure module operable to remove a pre-determined amount of air from the cavity so as to provide a negative pressure between the primary and secondary cuff portions.
  • the inter-cuff negative pressure module comprises an air suction device; and a negative pressure channel connected to the air suction device and carried by the tubing, wherein the negative pressure channel is connected to a position between the primary and secondary cuffs along the tubing.
  • the primary and secondary cuff portions comprise one or more of the following materials:- polyvinyl chloride (PVC), polyurethane (PU), polypropylene, low-density polyethylene (LDPE), polyethylene terephthalate (PET), polyamide (PA), polyisoprene, silicone and neoprene.
  • the primary and secondary cuff portions are formed with a wall thickness of between 0.06mm and 0.40mm.
  • a method of using an endotracheal tube comprising the steps of: - inserting a tubing of the endotracheal tube into the trachea, the tubing carrying a primary cuff portion and a secondary cuff portion spaced apart along the tubing, the primary cuff portion is placed nearer to a machine end of the endotracheal tube and the secondary cuff portion is placed nearer to a patient end of the endotracheal tube; lodging the endotracheal tube within the trachea and forming a cavity between the primary and secondary cuff portions by operating the primary and secondary portions to seal against an inner tracheal wall; and collecting and retaining a fluid within the trachea using at least one of the primary and secondary cuff portions.
  • the method further comprises one or more of the following steps: - drawing the collected and retained fluid out from the trachea through a drainage channel; inflate the primary and secondary cuff portions to a desired pressure using cuff inflation module; removing a pre-determined amount of air from the cavity using an inter-cuff negative pressure module so as to provide a negative pressure between the primary and secondary cuff portions.
  • the primary cuff portion is concave-shaped cuff operable to collect and retain the fluid
  • the secondary cuff portion is a convex-shaped cuff.
  • the concave-shaped cuff comprises an opening part for collecting the fluid and a body part for retaining the fluid, the body part comprising one or more support members so as to allow the concave- shaped cuff to maintain its shape.
  • a method of manufacturing the endotracheal tube comprising the steps of:- providing a tubing, a primary cuff portion, and a secondary cuff portion; attaching the primary cuff portion and the secondary cuff portion onto the tubing, wherein the primary cuff portion is positioned nearer to a machine end of the endotracheal tube, the secondary cuff portion being positioned nearer to a patient end of the endotracheal tube, and the primary and secondary cuff portions are operable to seal against an inner tracheal wall such that the endotracheal tube is lodged within the trachea, and wherein at least one of the primary and secondary cuff portions is a concave-shaped cuff operable to collect and retain a fluid; and spacing the primary cuff portion and the secondary cuff portion apart by a distance along the tubing such that a cavity is formed between the first and secondary cuff portions when the endotracheal
  • FIG. 1 shows a perspective view of an endotracheal tube according to one embodiment of the disclosure
  • Fig. 2 shows a perspective view of the endotracheal tube of Fig. 1 from another angle
  • FIG. 3 illustrate a patient end of the endotracheal tube of Fig. 1 ;
  • Fig. 4 shows an exemplary scenario in association with the endotracheal tube of Fig. 1, according to one embodiment of the disclosure;
  • Fig. 5 shows a concave-shaped cuff for use with the endotracheal tube in accordance to one embodiment of the disclosure
  • Fig. 6 shows a convex-shaped cuff for use with the endotracheal tube in accordance to one embodiment of the disclosure ;
  • FIG. 7 shows an endotracheal tube and an exemplary scenario in association with the endotracheal tube, according to another embodiment of the disclosure
  • Fig. 8 shows a method in association with the construction of the endotracheal tube of Fig. 1, according to an embodiment of the disclosure; and [0028] Fig. 9 shows a method of using an endotracheal tube, according to an embodiment of the disclosure.
  • range format is merely for convenience and brevity and should not be construed as a limitation on the scope of the disclosed ranges. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. Ranges are not limited to integers, and can include decimal measurements. This applies regardless of the breadth of the range.
  • the term‘patient end’ refers to one end of the endotracheal tube, when deployed in a subject, an individual or a patient, is relatively near to the lung.
  • the term‘machine end’ refers to one end of the endotracheal tube which has a portion outside the body of the subject. The machine end of the endotracheal tube may be connected with a ventilator and/or with other external devices.
  • the term‘individual’,‘subject’ or‘patient’ may refer to any individual or organism with a trachea.
  • the subject may include any Gnathostomata or jawed vertebrate, such as mammals, preferably humans.
  • Gnathostomata or jawed vertebrate such as mammals, preferably humans.
  • an endotracheal tube 100 comprises a tubing 102 insertable into a trachea 202 of a subject, a primary cuff portion 104 and a secondary cuff portion 106 being carried by the tubing 102 and being spaced apart along the tubing 102, the primary cuff portion 104 being positioned nearer to a machine end 102a (i.e., relative/compared to the patient end 102b) of the endotracheal tube 100, the secondary cuff portion 106 being positioned nearer to a patient end 102b (i.e., relative/compared to the machine end 102a) of the endotracheal tube 100.
  • the primary cuff portion 104 can be carried by the tubing 102 nearer to the machine end 102a as compared to the patient end 102b whereas the secondary cuff portion 106 can be earned by the tubing 102 nearer to the patient end 102b as compared to the machine end 102a.
  • the primary and secondary cuff portions 104, 106 are operable to seal against an imier tracheal wall such that the endotracheal tube 100 is lodged within the trachea 202 and a cavity 204 or a special region 204 is formed between the first and secondary cuff portions 104, 106, and at least one of the primary and secondary cuff portions 104, 106 is operable to collect and retain a fluid 206 within the trachea.
  • the tubing 102 can be in the form of an elongated structure. In some embodiments, the tubing 102 can be in the form of an elongated hollow structure with one or more inner channels/lumens.
  • the tubing 102 is configured with a suitable length and diameter so as to facilitate insertion into the trachea 202.
  • the machine end 102a and the patient end 102b may be opposing ends of the tubing 102 which define the extremities of the tubing 102.
  • the primary cuff portion 104 and the secondary cuff portion 106 are carried by the tubing 102.
  • the primary and secondary cuff portions 104, 106 are attached or mounted onto the tubing 102.
  • the primary and secondary cuff portions 104, 106 form two protruding portions or two volume expansion portions along the tubing 102 which are spaced apart by a distance along the tubing 102.
  • the endotracheal tube 100 may extend through the mouth of a patient and be positioned in the trachea 202.
  • the endotracheal tube 100 may be inserted into a depth of approximately 2-3 cm above the carina of the patient, so as to facilitate air flow in and out of the lungs and to remove bodily fluids in the trachea.
  • the primary and secondary cuff portions 104, 106 act to lodge or anchor the endotracheal tube 100 within the trachea 202, and act to seal against the inner tracheal wall. More specifically, the primary and secondary cuff portions 104, 106 engage with the inner tracheal wall in a manner such that unintended movement of the endotracheal tube 100 within the trachea may be avoided or minimized. Further, the primary and secondary cuff portions 104, 106 also prevent collapse of the trachea 202 and assure a passage for the flow of air or other gases into/out of the lungs through the trachea. In some procedures, the primary and secondary cuff portions 104, 106 may act to protect the airway against aspiration (e.g. to prevent stomach contents to be accidentally breathed in).
  • aspiration e.g. to prevent stomach contents to be accidentally breathed in.
  • At least one of the primary and secondary cuff portions 104, 106 is a concave-shaped cuff 250 operable to collect and retain a fluid 206, such as subglottic secretions within the trachea 202.
  • the concave-shaped cuff 250 comprises an opening part 250a for collecting the fluid and a body part 250b for retaining the fluid.
  • the concave shaped cuff 250 can, for example, correspond to a pressure cuff shaped and dimensioned to collect and retain fluid/fluids (e.g., nasopharyngeal secretions, saliva and/or vomitus).
  • the secondary cuff portion 106 is a convex-shaped cuff 270.
  • the concave-shaped cuff 250 can include an opening part 250a (i.e., opening of the concave/basin structure) and a body part 250b (i.e., body of the concave/basin structure).
  • the opening part 250a of the concave can be facing the machine end 102a.
  • the body part 250b can be shaped and dimensioned so that fluid(s) can be accommodated/retained within the body part 250b. Specifically, fluid(s) can be collected via the opening part 250a and into the body part 250b. Collected fluid(s) can be accommodated/retained within the body part 250b.
  • the convex-shaped cuff 270 may be of any suitable convex shape to allow a portion of the cuff 270 to adhere to and seal against the inner tracheal wall for lodging the endotracheal tube 100 in the trachea.
  • the convex-shaped cuff 270 may be in a cylindrical shape, a pear-like shape (i.e. a barrel shape having a short-tapered region at one end), or a tapered/conical shape.
  • Fig. 5 and Fig. 6 illustrate non-limiting examples of the concave-shaped cuff
  • the concave-shaped cuff 250 comprises a proximal sleeve
  • the body part 250b of the concave-shaped cuff 250 may comprise an inner wall 257 and an outer wall 258.
  • An inflatable space 259 is defined by the inner wall 257 and the outer wall 258.
  • the inner wall 257 of the concave-shaped cuff 250 is configured to gradually taper or narrow down towards the proximal sleeve 253 of the concave-shaped cuff.
  • the outer wall 258 may comprise a relatively flat region nearer to the opening part 250a, where the outer wall 258 is extending substantially parallelly with respect to the central axis of the cuff 250. This flat region is configured to form an effective contact/sealing area with the inner tracheal wall when the endotracheal tube 100 is lodged in the trachea.
  • the outer wall 258 is configured to narrow down towards to the distal sleeve 252 across a tapered region.
  • the tapered region of the outer wall 250 may be disposed at an angle of between 10 to 45 degrees with respect to the central axis of the cuff 250. In some embodiments, the tapered region of the outer wall 250 may be disposed at an angle of between 20 to 40 degrees with respect to the central axis of the cuff 250.
  • a pressurized air flow may be directed into inflatable space 259 to inflate the concave-shaped cuff 250 into a desired shape and dimension.
  • the concave-shaped cuff 250 when inflated, is able to conform to the shape of the inner trachea wall to form an effective seal against the inner trachea wall.
  • the concave-shaped cuff 250 configured in this manner may effectively prevent any accumulation of fluids around the peripheral regions of the cuff 250. This greatly reduces the possibility of leakage of any bodily fluid through the cuff.
  • the inner wall 257 and the outer wall 258 of the concave-shaped cuff 250 may be formed with varying thickness.
  • the thickest portion corresponds to the sleeve portion (i.e. the proximal sleeve 252 and the distal sleeve 253). This allows the sleeves 252, 253 to be firmly attached to and form a tight sealing around the tubing 102.
  • the thickness of the inner wall 257 and the outer wall 258 may gradually decrease along the body part 250b to provide a desired softness and elasticity of the body part 250b such that it can better conform with the shape of the trachea when inflated and that any damage to the tracheal wall (or discomfort caused to the patient) due to the insertion of endotracheal tube 100 may be minimized.
  • the body part 250b comprises one or more support members 105 so as to maintain and reinforce its concave shape.
  • the support members 105 may be multiple ribs 105 arranged surrounding the inner wall 258 of the body part 250b of the concave-shaped cuff 250.
  • the rib-like support members 105 may be positioned at an angle with respect to the elongated axis of the concave-shaped cuff 250.
  • the rib-like support members 105 provide structural stability and allow the concave-shaped cuff 250 to maintain its shape when inflated.
  • the support member 105 may be configured as a separate concave structure that may be attached to the concave-shaped cuff 250 for structural support.
  • the convex-shaped cuff 270 as shown in Figure 6 is a tapered/ conical shaped cuff.
  • the convex-shaped cuff 270 comprises two sleeves, i.e. a proximal sleeve 272 and a distal sleeve 273 corresponding to a proximal opening 275 and a distal opening 276 for receiving the tubing 102.
  • the proximal sleeve 272 and the distal sleeve 273 are configured to seal around the tubing 102, so as to prevent any bodily fluids to the flow therethrough.
  • the convex-shaped cuff 270 may comprise an inner wall (not shown in Figure 6) and an outer wall 258, defining an inflatable space 279 within the cuff 270.
  • the convex-shaped cuff 270 may be fonned with a varying wall thickness, with the thickest portion corresponding to the sleeves 272, 273, and gradually decrease across the tapered-shape body part.
  • the primary and secondary cuff portions 104. 106 are constrained by the inner tracheal wall and therefore may be deformed when lodged within the trachea 202. Also, as the size and geometry of patient’s trachea can vary, the intubation procedure can cause the cuff portions 104, 106 to in an off-centered position. The deformation and movement of the two cuff portions 104, 106 may result in longitudinal folds formed at the cuff surface, particularly at the contact portions formed between the cuff portions 104, 106 and the inner tracheal wall. Such longitudinal folders may potentially provide a fluid leakage passage that allows the body fluid(s) such as secretions to flow through, which is undesired.
  • the concave-shaped cuff 250 and the convex-shaped cuff 270 as described above, when used in the endotracheal tube 100, provide the benefits of reducing the chance of inevitably creating the longitudinal folds.
  • the inclusion of a tapered region in the concave-shaped cuff 250 and the tapered shaped of the convex-shaped cuff 270 allows only a portion of the cuff surface to adhere to the inner tracheal wall.
  • the level of deformation of the cuffs 250, 270 and the chance of forming the longitudinal folds during the intubation procedure is therefore reduced.
  • suitable materials may be used for forming the various components of the endotracheal tube 100 to provide the desired properties.
  • the two cuff portions 104, 106 and the tubing 102 may be formed from inert materials which do not react with the body fluid(s).
  • biocompatible and hypoallergenic materials having other desired mechanical properties (e.g. being sufficiently flexible and soft) and chemical properties (e.g. being chemically stable during a prolonged period) may be used for forming the various components of the endotracheal tube 100.
  • the tubing 102 can be formed from silicon rubber with or without di(2-ethylhexyl) phthalate (DEHP) plasticizer.
  • DEHP di(2-ethylhexyl) phthalate
  • the DEHP is added to provide a certain degree of softness to the tubing 102 formed so that it does not damage the trachea 202 of the subject.
  • the primary and secondary cuff portions 104, 106 may be formed from one or more of the following materials: polyvinyl chloride (PVC), polyurethane (PU), polypropylene (PP), low-density polyethylene (LDPE), polyethylene terephthalate (PET), polyamide (PA).
  • PVC polyvinyl chloride
  • PU polyurethane
  • PP polypropylene
  • LDPE low-density polyethylene
  • PET polyethylene terephthalate
  • PA polyamide
  • the primary and secondary cuff portion 104, 106 may be formed from suitable elastomers including, but not limited to, polyisoprene, silicone and neoprene.
  • the primary and secondary cuff portions 104, 106 are foimed with a wall thickness of between 0.06mm and 0.40mm. In such a manner, structural integrity and stability of the cuff portions 104, 106 may be achieved.
  • the wall thickness of the concave-shaped cuff 250 may be in a range of between 0.07mm and 0.35mm. In some embodiments, the thickness of the two sleeves 252, 253 may be in a range of between 0.18mm and 0.33mm, which gradually decrease along the body part 250b to a thickness in the range of about 0.07mm and 0.12mm.
  • the wall thickness of the convex-shaped cuff 270 may be in a range of between 0.06mm and 0.30mm. In some embodiments, the thickness of the two sleeves 272, 273 may be in a range of between 0.15mm and 0.25mm, which gradually decrease along the body part. The wall thickness of the body part of the convex-shaped cuff 270 may be in a range of about 0.06mm and 0.10mm.
  • the endotracheal tube 100 and particularly the tubing 102 may be configured with one or more internal lumens and one or more corresponding external channels to facilitate the operation of the cuff portions 104, 106.
  • the endotracheal tube 100 may further comprise a drainage channel 107 carried by the tubing 102, wherein the drainage channel 107 is configured to draw the collected and retained fluid(s) 206 out from the trachea 202.
  • the drainage channel 107 can, for example, correspond to a subglottic drainage catheter.
  • the drainage channel 107 can be earned by the tubing 102 in a manner so as to facilitate communication (e.g., of fluid/fluids) from concave-shaped cuff (corresponding to at least one of the primary and secondary cuff portions 104, 106).
  • the drainage channel 107 can be configured to facilitate communication, from the concave-shaped cuff, of the afore-mentioned collected and retained fluid(s). Specifically, collected fluid(s) 206 can be drawn out of (i.e., communicated from) the concave-shaped cuff via the drainage channel 107. In this regard, the drainage channel 107 can be earned by the tubing 102 in a manner so as to be positioned relative to the concave-shaped cuff for communication of collected and retained fluid(s) from (i.e., out of) the primary cuff portion 104.
  • the drainage channel 107 may comprise a portion positioned outside the tubing 102, which is also referred to as an external drainage channel 107’, and a portion positioning within the tubing 102, which is also referred to as an internal drainage channel/lumen 107”.
  • the external drainage channel 107 is in fluid connection with the internal drainage lumen 107” which extends along the tubing 102 to the concave- shaped cuff 250 (or the primary cuff portion 104 in the embodiment of Figure 1).
  • an opening 107a of drainage channel 107 is positioned within the body part 270b of concave-shaped cuff 250, such that fluids collected by the concave-shaped cuff 250 may be drawn out through the drainage channel 107.
  • the endotracheal tube 100 may comprise a cuff inflation module operable to inflate the primary and secondary cuff portions 104, 106 to a desired pressure.
  • the cuff inflation module may comprise an inflation device (not shown), and an inflation channel 108 connected to the inflation device and carried by the tubing 102.
  • the inflation channel 108 is connected to the primary and secondary cuff portions 104, 106 respectively, and the inflation device is operable to inflate the primary and secondary cuff portions 104, 106 through the inflation channel 108.
  • the inflation channel 108 comprise an external inflation channel 108’ positioned outside the tubing 102 and an internal inflation lumen 108” embedded within the tubing 102.
  • the internal inflation lumen 108” comprises two openings 108a, 108b positioned at the primary and secondary cuff portions 104, 106 respectively.
  • the external inflation channel 108’ is connectable to the inflation device (not shown) which is an external device normally disposed outside the individual’s body.
  • the inflation device may be any suitable device that is capable of delivering a pressurized air/gas, via the inflation channel 108 and the two openings 108a, 108b, to the two cuff portions 104, 106.
  • a non-limiting example of the inflation device may be a pilot balloon controlled by and connected to the inflation channel 108 using a Luer valve.
  • the inflation module operates to introduce a one-direction airflow to both cuff portions 104, 106 at the same time, and therefore allows both cuff portions 104, 106 to be inflated simultaneously or almost simultaneously to a desired pressure.
  • the primary and secondary cuff portions 104, 106 are inflated to an expanded volume.
  • the inflated primary and secondary cuff portions 104, 106 may form a tight seal against the inner trachea wall to prevent any leakage of fluid(s) therethrough, and also to prevent the tubing 102 from moving out of place.
  • the inflation pressure may be determined and controlled, e.g., by a practitioner, according to the conditions of the patients/individuals.
  • the endotracheal tube 100 may further comprise an inter-cuff negative pressure module operable to remove a pre-determined amount of air from the cavity 204 so as to provide a negative pressure between the primary and secondary cuff portions 104, 106.
  • the inter-cuff negative pressure module may comprise an air suction device
  • a negative pressure channel 109 connectable to the air suction device and being earned by the tubing 102, wherein the negative pressure channel is connected to a position between the primary and secondary cuff portions 104, 106 along the tubing 102.
  • the negative pressure channel 109 may be configured with an external negative inter-cuff channel 109’ disposed outside the tubing 102, an internal negative inter- cuff lumen 109” embedded within the tubing 102, wherein an opening 109a of the lumen 109 is at a position between the primary and the secondary cuff portions 104, 106.
  • the negative pressure channel 109 is arranged to extend a length at least from the air suction device to an opening 109a positioned in the cavity 204.
  • the air suction device is an external device that is place outside the patient/individual’s body and may be any suitable device that is capable of removing a volume of air from the cavity 204 through the negative pressure channel 109.
  • the air suction device may be a pilot balloon connected to the via a Luer valve, or a syringe with a Luer valve nozzle connectable to the inflation channel.
  • the negative pressure module provides the benefits of minimizing the longitudinal folds formed at the surface of the cuff portions 104, 106.
  • the negative pressure exerted on surfaces of the two cuff portions 104, 106 i.e. the cuff surfaces that are facing the cavity 204 may act as a pulling force that is able to smoothen/lessen the longitudinal folds or other forms of surface deformation on the cuff portions 104, 106. Accordingly, the sealing effect of the cuff portions 104, 106 against the trachea 202 is improved, and fluid leakage through the cuff portions 104, 106 is minimized.
  • the concave- shaped cuff is formed with the one or more support members 105.
  • the support members 105, the inter-cuff negative pressure, and the inflation pressure act together to minimize surface deformation or the longitudinal folds.
  • Such a concave-shaped cuff is further advantageous in that it may maintain its shape within the trachea 202.
  • the functionality of the endotracheal tube 100 is therefore not tend to be affected or compromised by the conditions within the trachea 202.
  • Fig. 4 shows an exemplary scenario 200 in association with the endotracheal tube 100 whereby the primary cuff portion 104 is configured as a concave shaped cuff for collecting and retaining fluid(s). More specifically, Fig. 4 shows an exemplary scenario 200 in which the endotracheal tube 100 is inserted into an individual (not shown). Yet more specifically, in the exemplary scenario 200, the endotracheal tube 100 can be inserted into an individual’s trachea 202.
  • a cavity or a spatial region 204 can be defined between the primary cuff portion 104 and the secondary cuff portion 106 after the endotracheal tube 100 has been inserted into, and positioned within, the trachea 202.
  • a cavity 204 can be defined between the primary cuff portion 104 and the secondary cuff portion 106 after the endotracheal tube 100 has been lodged within the trachea 202.
  • the primary cuff portion 104 and the secondary cuff portion 106, as carried by the tubing 102, can be spaced apart such that a cavity 204 or spatial region 204 can be defined (i.e., between the primary and secondary cuff portions 104/106) after the endotracheal tube 100 has been lodged within the trachea 202.
  • the primary cuff portion 104 and the secondary cuff portion 106 can be in contact with the trachea 202, defining a first contact portion 205a and a second contact portion 205b.
  • the first contact portion 205a can be defined based on contact established between the primary cuff portion 104 and the trachea 202
  • the second contact portion 205b can be defined based on contact established between the secondary cuff portion 106 and the trachea 202.
  • Fluid/Fluids 206 can be collected and retained by the primary cuff portion 104.
  • fluid(s) 206 can be collected by the primary cuff portion 104 via its opening part 104a and retained/accommodated within its body part 104b. More specifically, fluid(s) 206 (e.g., nasopharyngeal secretions, saliva and/or vomitus) can enter the primary cuff portion 104 via the opening part 104a, communicated (e.g., by manner of flowing) into the body part 104b and, subsequently, retained/accommodated within the body part 104b. In this regard, fluid(s) 206 can be earned by the primary cuff portion 104.
  • fluid(s) 206 e.g., nasopharyngeal secretions, saliva and/or vomitus
  • the primary cuff portion 104 can generally be in the form of a concave based structure (e.g., a basin structure) which can facilitate in the collection and retention of fluid(s) 206.
  • a concave based structure e.g., a basin structure
  • it can, for example, correspond to a concave structure capable of providing a directed path for fluid(s) 206 to be collected and retained (i.e., fluid(s) 206 can enter the primary cuff portion 104 via the opening part 104a and, subsequently, retained/accommodated within the body part 104b, as mentioned earlier.
  • the primary cuff portion 104 can impede flow of fluid(s) 206 beyond the second contact portion 205b. Specifically, flow of fluid(s) 206 along the trachea 202 beyond the second contact portion 205b can be impeded (i.e., by the primary cuff portion 106).
  • Fluid(s) 206 can then be drawn out of the trachea 202 by manner of suction.
  • the drainage channel 107 can be carried by the tubing 102 so as to be positionally optimal for the purpose of drawing fluid(s) 206 out of the trachea 202.
  • the drainage channel 107 can, for example, be positioned relative to the secondary cuff portion 106 so as to be capable of drawing fluid(s) 206 carried by the secondary cuff 106 out of the trachea 202.
  • the present disclosure in one embodiment, contemplates a combination of impeding flow of fluid(s) 206 beyond the secondary cuff portion 106 and drawing fluid(s) 206 retained in the primary cuff portion 104 out of the trachea 202 (i.e., in association with the drainage channel 107) for minimizing the possibility of, for example, ventilator-associated pneumonia (VAP) from occurring (i.e., hence advantageously at least reducing/mitigating health related risk(s)).
  • VAP ventilator-associated pneumonia
  • the present disclosure in other embodiments, further contemplates utilizing inflation pressure (i.e.
  • the present disclosure contemplates an endotracheal tube 100’ of a different configuration as shown in Fig. 7.
  • Fig. 7 includes a tubing 102, a primary cuff portion 104 and a secondary cuff portion 106.
  • the primary cuff portion 104 can be carried by the tubing 102 nearer to its machine end 102a whereas the secondary cuff portion 106 can be carried by the tubing 102 nearer to its patient end 102b.
  • the cuff portions 104, 106 are spaced apart along the tubing 102.
  • a cavity or spatial region 204 is defined between the primary and secondary cuff portions 104, 106.
  • the secondary cuff portion 106 is concave shaped cuff operable to collect and retain a fluid 206 within the trachea 202
  • the primary cuff portion 104 is a convex-shaped cuff (e.g. a cylindrical cuff, or a tapered cuff).
  • the secondary cuff portion 106 can include an opening part 106a and a body part 106b.
  • the opening part 106a can be shaped and dimensioned in a manner so as to be capable of collecting fluid(s) 206.
  • the opening part 106a can correspond to an opening which can allow fluid(s) to be communicated (e.g., by manner of flowing) into the body part 106b.
  • the body part 106b can be shaped and dimensioned in a manner so as to be capable of retaining fluid(s) 206.
  • the endotracheal tube 100’ may further include a drainage chamiel 107 which can be carried by the tubing 102.
  • the drainage channel 107 can be positioned relative to the secondary cuff portion 106 so as to be able to draw collected and retained fluid(s) 206 from (i.e., out of) the secondary cuff portion 106.
  • fluid(s) 206 carried by the secondary cuff portion 106 can be drawn from (i.e., communicated from) the secondary cuff portion 106 via the drainage channel 107.
  • the primary and secondary cuff portions 104, 106 may be connected to an inflation device via an inflation channel 108, which is operable to inflate the two cuff portions 104, 106 to a pre-determined pressure.
  • the endotracheal tube 100’ may further comprise an inter-cuff negative pressure module operable to remove a pre-determined amount of air from the cavity 204.
  • drawing of fluid(s) from the secondary cuff portion 106 can be facilitated by the negative pressure created by the negative pressure module.
  • suction can be by manner of negative pressure exerted within the cavity 204, such that fluid(s) 206 present within the spatial region 204 and/or earned by the secondary cuff portion 106 can be drawn out of the trachea 202.
  • a separate air suction device may not be required for use with the endotracheal tube 100’ as the negative pressure module operates to create a pressure difference between the two ends of the drainage channel 107 and acts to facilitate flow of the retained fluid(s) out from the secondary cuff portion 106.
  • the present disclosure in the embodiment of Fig. 7, further contemplates utilizing negative pressure (i.e., in association with the cavity 204 formed between the primary and secondary cuff portions 104, 106) for assisting in drawing fluid(s) 206 out of the trachea 202 via the drainage channel 107 by manner of suction.
  • negative pressure i.e., in association with the cavity 204 formed between the primary and secondary cuff portions 104, 106 for assisting in drawing fluid(s) 206 out of the trachea 202 via the drainage channel 107 by manner of suction.
  • FIG. 8 a method 300 in association with the endotracheal tube 100, 100’, and specifically, a method 300 of construction in association with the endotracheal tube 100, 100’, is shown.
  • the method 300 can, in one embodiment, include any one of a first providing step 302, a second providing step 304 and a third providing step 306, or any combination thereof. Specifically, in one embodiment, the method 300 can include a first providing step 302, a second providing step 304 and/or a third providing step 306.
  • the tubing 102 can be provided.
  • the second providing step 304 one or both of the primary cuff portion 104 and the secondary cuff portion 106 can be provided.
  • the primary and secondary cuff portion 104, 106 are attached onto the tubing 102, wherein the primary cuff portion 104 is positioned nearer to a machine end 102a of the endotracheal tube 100, the secondary cuff portion 106 being positioned nearer to a patient end 102b of the endotracheal tube 100, and the primary and secondary cuff portions 104, 106 are operable to seal against an inner tracheal wall such that the endotracheal tube 100 is lodged within the trachea, and wherein at least one of the primary and secondary cuff portions 104, 106 is a concave-shaped cuff operable to collect and retain a fluid, as described above.
  • the primary and secondary cuff portion 104, 106 are spaced apart by a distance along the tubing 102 such that a cavity 204 is formed between the first and secondary cuff portions 104, 106 when the endotracheal tube 100 is lodged within the trachea 202.
  • the drainage channel 107 can be provided.
  • the method 300 can further include coupling the primary cuff portion 104, the secondary cuff portion 106 and/or the drainage channel 107 to the tubing 102 such that the tubing 102 can carry the primary cuff portion 104, the secondary cuff portion 106, the drainage channel 107, the inflation channel 108, and/or negative pressure channel 109.
  • the tubing 102 can be shaped and dimensioned in a manner so as to be capable of carrying any one, or any combination of, the primary cuff portion 104, the secondary cuff portion 106, the drainage channel 107, the inflation channel 108, and/or negative pressure channel 109.
  • a method 400 of using an endotracheal tube 100, 100’ which comprises the following steps [00113]
  • a tubing 102 of the endotracheal tube 100, 100’ is inserted into the trachea 202, the tubing 102 carrying a primary cuff portion 104 and a secondary cuff portion 106 spaced apart along the tubing 102, the primary cuff portion 104 is placed nearer to a machine end 102a of the endotracheal tube 100, 100’ and the secondary cuff portion 106 is placed nearer to a patient end 102b of the endotracheal tube 100, 100’,
  • a step 402 the endotracheal tube 100, 100’ is lodged within the trachea
  • a cavity 204 is formed between the primary and secondary cuff portions 104, 106 by sealing the primary and secondary portions 104, 106 against the inner trachea wall,
  • a fluid 206 within the trachea 202 is collected using at least one of the primary cuff portion 104 and the secondary cuff portion 106. More specifically, at least one of the primary and secondary cuff portions 104, 106 is a concave-shaped cuff 250 with an opening part 250a for collecting the fluid(s) and a body part 250b for retaining the fluid(s) 206.
  • the body part 250b may comprise one or more support members 105 so as to allow the concave-shaped cuff to maintain its shape when placed.
  • the collected and retained fluid 206 is drawn out from the trachea through a drainage channel 107.
  • the endotracheal tube 100, 100’ may be placed in the trachea 202 for a prolonged period of time.
  • the step 404 may be performed to empty to the retained fluid 206 periodically.
  • the primary and secondary cuff portions 104, 106 are inflated to a desired pressure using a cuff inflation module. More specifically, an inflation device may be used to introduce a pressurized air/gas into the primary and secondary cuff portions 104, 106 via an inflation channel 108.
  • the inflation channel 108 may be a lumen with the tubing 102 or may be otherwise carried by the tubing 102.
  • a pre-determined amount of air is removed from the cavity 204 between the primary and secondary cuff portions 104, 106 using an inter-cuff negative pressure module. In this manner, a negative pressure is created between the primary and secondary cuff portions 104, 106.
  • VAP ventilator-associated pneumonia
  • the method is further advantageous in that the use of inflation pressure (i.e. as provided by the cuff inflation module to inflate the cuff portions 104, 106 to a desired pressure) and an inter-cuff negative pressure (i.e., in association with the cavity 204 formed between the primary and secondary cuff portions 104, 106) both act to improve the sealing effect of two cuff portions 104, 106 against the trachea. Fluid leakage is therefore minimized using the endotracheal tube of the present disclosure. [00121] It should be further appreciated by the person skilled in the art that variations and combinations of features described above, not being alternatives or substitutes, may be combined to form yet further embodiments.
  • the cuff portions 104, 106 and the tubing 102 may be fomied as separate components and assembled together, or be integrally formed as a one-piece element.
  • the size and dimension of the concave-shaped cuff 250 and the convex-shaped cuff 270 may be adjusted or customized according to the conditions of the patient (e.g.
  • the drainage device may be set to drain the fluids from the concave-shaped cuff 250 at a pre-determined time interval depending on the conditions of the patient.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un tube endotrachéal comportant: un tube pouvant être inséré dans une trachée d'une personne, une partie de manchon primaire et une partie de manchon secondaire étant portées par le tube et espacées le long du tube, la partie de manchon primaire étant positionnée plus près d'une extrémité de machine du tube endotrachéal, la partie de manchon secondaire étant positionnée plus près d'une extrémité de patient du tube endotrachéal, et les parties de manchon primaire et secondaire pouvant être actionnées pour se plaquer hermétiquement contre une paroi interne trachéale de sorte que le tube endotrachéal soit logé à l'intérieur de la trachée et une cavité est formée entre les première et seconde parties de manchon, et au moins l'une des parties de manchon primaire et secondaire étant un manchon de forme concave utilisable pour recueillir et retenir un fluide à l'intérieur de celui-ci. L'invention concerne également un procédé d'utilisation du tube trachéal. La présente invention concerne également un procédé de fabrication du tube trachéal.
PCT/SG2020/050178 2019-03-27 2020-03-27 Tube endotrachéal et procédé associé WO2020197506A1 (fr)

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SG10201902719X 2019-03-27

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4979505A (en) * 1989-06-06 1990-12-25 Cox Everard F Tracheal tube
US20090032027A1 (en) * 2007-07-30 2009-02-05 Mccachren Brian Christopher Multiple balloon endotracheal tube cuff
US20090260632A1 (en) * 2008-04-22 2009-10-22 Freddy Abnousi Endotracheal Tube
US20160101253A1 (en) * 2014-10-08 2016-04-14 Husam Ibrahim ALAHMADI Protective endotracheal tube
US20190060594A1 (en) * 2017-08-31 2019-02-28 Qscope, LLC Endotracheal tube drainage system and methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4979505A (en) * 1989-06-06 1990-12-25 Cox Everard F Tracheal tube
US20090032027A1 (en) * 2007-07-30 2009-02-05 Mccachren Brian Christopher Multiple balloon endotracheal tube cuff
US20090260632A1 (en) * 2008-04-22 2009-10-22 Freddy Abnousi Endotracheal Tube
US20160101253A1 (en) * 2014-10-08 2016-04-14 Husam Ibrahim ALAHMADI Protective endotracheal tube
US20190060594A1 (en) * 2017-08-31 2019-02-28 Qscope, LLC Endotracheal tube drainage system and methods

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