WO2010062603A1 - Méthode et appareil de protection trachéale pendant une ventilation - Google Patents

Méthode et appareil de protection trachéale pendant une ventilation Download PDF

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Publication number
WO2010062603A1
WO2010062603A1 PCT/US2009/062227 US2009062227W WO2010062603A1 WO 2010062603 A1 WO2010062603 A1 WO 2010062603A1 US 2009062227 W US2009062227 W US 2009062227W WO 2010062603 A1 WO2010062603 A1 WO 2010062603A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
tube
along
balloon
cuff
Prior art date
Application number
PCT/US2009/062227
Other languages
English (en)
Inventor
Oron Zachar
Original Assignee
Feigelson, Daniel
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 Feigelson, Daniel filed Critical Feigelson, Daniel
Publication of WO2010062603A1 publication Critical patent/WO2010062603A1/fr
Priority to PCT/US2010/039881 priority Critical patent/WO2010151713A2/fr
Priority to EP10792693A priority patent/EP2445562A2/fr
Priority to US12/823,114 priority patent/US20110048427A1/en
Priority to US13/095,361 priority patent/US20110290246A1/en

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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
    • 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
    • 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
    • A61M16/0479—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids above the cuff, e.g. giving access to the upper trachea
    • 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
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment

Definitions

  • an endotracheal tube (ETT) 100 which is inserted into a patient airway 111 typically includes an inflatable balloon or cuff 112 near its distal end.
  • the cuff 112 when inflated, performs a dual function: (a) the cuff occludes the air passageway, thus establishing a closed system whereby the gas pressure in the airway distal to the inflated cuff can be maintained at a desired level, thus providing means of controlling the exchange of blood gases in lungs, (b) the cuff provides a barrier against inflow of aspirated gastric contents or other matter foreign to the lungs.
  • VAP ventilation associated pneumonia
  • the inflatable cuff on a typical commercially available endotracheal tube, is in the form of an oval-shaped balloon.
  • the oval- shaped balloon permits these secretions to pool around the surface of the balloon proximal to the oral cavity, particularly in the vicinity of the region where the balloon contacts the tracheal wall; sometimes these fluids pass by the balloon and into the tracheo-bronchial tree.
  • This passage of unwanted fluids past the inflated cuff of the tracheal tube device is thought to be due to the patient's breathing cycle producing fluctuating inhalation/exhalation pressures on the downstream ovate surface of the inflated cuff, causing the cuff and/or the tracheal conduit to act somewhat in the manner of a peristaltic pump.
  • the tube device is provided not only with an inflation line to the cuff but also with a suction line opening to a region above the cuff.
  • the opening from the suction line is disposed too far above the upstream ovate surface of the cuff to ensure removal by suction of all the unwanted fluids collecting in that region.
  • oval shape of the cuff inevitably leads to having the most crucial area of fluid collection, at the contact between the cuff and the trachea surface, being too narrow for the reach of any suction device. Hence, suction above oval balloons may not ensure complete removal of all secretions.
  • a second major set of complications arising from tracheal intubation is associated with the cuff sealing pressure.
  • the pressure in the cuff must be equal to or greater than the peak inspiratory pressure within the airway. Peak inspiratory pressures are only achieved for 10%-25% of the ventilatory cycle but may be as high as 50 mm of mercury. Since the pressure within the standard cuff is static, to achieve continuous good sealing the cuff pressure must ideally be maintained at this relatively high pressure (equal to or greater than peak airway pressure) throughout the ventilatory cycle, to prevent leaks during the highest pressure portion of the cycle.
  • tissue anoxia cannot be implemented in practice due to the risk of tissue anoxia and other complications: as the cuff pressure exceeds the capillary pressure of the tracheal tissues (which is normally 25 mm of mercury), tissue anoxia occurs, and varying degrees of tracheal injury result.
  • the injuries range from mild erosion of the mucosa, to destruction of the tracheal cartilage rings, to segmental tracheomalacia with dilatation of the trachea. More dramatic is full thickness erosion, with perforation of the inominate artery anteriorly or posteriorly into the esophagus; both of these events are associated with a high rate of mortality. Late complications of tracheal stenosis, from mild to incapacitating obstruction, are most often observed in patients requiring long-term ventilatory support, such as patients hospitalized in the ICU.
  • tracheal stents are known in the art. Unlike ETT' s, however, which are generally used to control a patient's breathing, tracheal stents are merely used to keep the air passage open.
  • the state of the art of tracheal stents is exemplified in www.emedicine.com/ent/topic593.htm and in Ann. Thorac. Med. (2006) 1:92-7, US patent publication 20030024534, PCT patent publication WO 2004/067060 A2, and references therein.
  • a method for tracheal intubation in a patient in need thereof comprising aligning, in the trachea of the patient, (a) a tracheal tube having a distal end which is inserted into the trachea and a proximal end which remains outside the trachea; (b) a sleeve through which the tracheal tube passes, the sleeve having an inner surface which faces the tracheal tube and an outer surface and proximal and distal ends which correspond to the proximal and distal ends, respectively, of the tracheal tube, the sleeve being of a length less than the distance between the larynx and the carina; and (c) a cuff which contacts at least a portion of the outer surface of the tracheal tube and at least a portion of the inner surface of the sleeve in a manner which substantially creates a seal between the distal
  • the outer surface of the sleeve contacts the wall of the trachea.
  • the tube is inserted into the trachea before the sleeve is inserted into the trachea. In some embodiments, the tube is inserted into the trachea after the sleeve is inserted into the trachea. In some embodiments, the sleeve and the tube are inserted concomitantly into the trachea.
  • a method of reducing the likelihood of fluids leaking from the trachea of a patient undergoing intubation into a lung theorof comprising deploying a tracheal tube, a sleeve and a cuff into a human trachea such that after deployment, the tracheal tube passes through the sleeve within the trachea, the cuff contacts the outer surface of the tracheal tube and the inner surface of the sleeve and spaces the sleeve from the tube, and the outer surface of the sleeve contacts the trachea, so as to provide a seal, in the interstitial area between the wall of the trachea and the tube, between a proximal portion of the human trachea above the cuff and a distal portion of the human trachea below the cuff.
  • the cuff is an expandable cuff
  • the sleeve is longitudinally rigid and radially expandable along at least a portion thereof
  • the deploying includes: (a) simultaneously inserting the tracheal tube, the expandable cuff and the sleeve into the trachea; and (b) after the inserting, inflating the inflatable cuff, so as to cause radial expansion of the sleeve and create said seal by contacting the sleeve to an inner surface of the trachea and by sealingly contacting the inner surface of the sleeve and the outer surface of the tube.
  • the cuff is an expandable cuff
  • the sleeve is longitudinally rigid and radially expandable along at least a portion thereof
  • the deploying includes: (a) emplacing the sleeve in the trachea of the patient; (b) thereafter inserting the tube and the cuff into trachea such that the tube passes through the sleeve with cuff positioned between the tube and sleeve; and (c) thereafter expanding the cuff so that the outer surface of the sleeve contacts the wall of the trachea, the cuff contacts the inner surface of the sleeve and the outer surface of the tube and spaces the sleeve from the tube, whereby to provide said seal.
  • the cuff is an expandable cuff
  • the sleeve is longitudinally rigid and radially expandable along at least a portion thereof
  • the deploying includes: (a) inserting the tube and the cuff into trachea; (b) emplacing the sleeve in the trachea of the patient such that the tube passes through the sleeve with cuff positioned between the tube and sleeve; and (c) thereafter expanding the cuff so that the outer surface of the sleeve contacts the wall of the trachea, the cuff contacts the inner surface of the sleeve and the outer surface of the tube and spaces the sleeve from the tube, whereby to provide said seal.
  • the sleeve is sized and shaped to contact the tracheal wall.
  • the sleeve has a substantially circular cross-section; in some embodiments, the maximum diameter of the sleeve is not more than about 2.5 cm.
  • the sleeve has a non-circular cross section; in some embodiments, the sleeve is sized and shaped to contact the tracheal wall in a manner which substantially seals the lungs from the pharynx.
  • the sleeve is of a length that fits between the larynx and the carina. In some embodiments, the sleeve has a length of from 2 to 8 cm. In some embodiments, the distal end of the sleeve is positioned 2 to 6 cm above the carina.
  • the sleeve is substantially rigid in its axial direction along at least
  • the sleeve is substantially rigid in its axial direction along at least 60% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 70% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 80% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 90% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along substantially its entire length.
  • the sleeve is in the form of a rolled sheet of material. In some embodiments, at least one of the termini of the rolled sheet along the longitudinal axis thereof has a tapered geometry.
  • the sleeve comprises a plurality of rods which impart stiffness along the axial direction of the sleeve.
  • the rods are connected at alternate ends by flexible connectors.
  • the rods are arranged generally parallel to one another and are spaced from each other by flexible segments.
  • the sleeve is a radially expandable sleeve, and the method includes expanding the sleeve to the expanded state.
  • the sleeve is biased toward an expanded state.
  • the sleeve is biased toward an unexpanded state.
  • the sleeve comprises a shape memory material or a thermoplastic material which can be returned to an unexpanded state.
  • the sleeve comprises one or more covering layers which are impermeable to mucous, saliva and other bodily fluids.
  • at least one covering layer is made of latex, polyurethane or butyl rubber.
  • the sleeve comprises a deformable outer layer.
  • the deformable out layer is filled with a fluid.
  • the fluid is selected from air and a gel.
  • the cuff is a balloon, the length of which is less than the length of the sleeve.
  • balloon is generally ring- or donut-shaped.
  • along at least an inner circumference of the balloon the balloon contacts the tube and along at least an outer circumference of the balloon the balloon contacts the inner surface of the sleeve.
  • along said at least an inner circumference the balloon is attached to said tube.
  • the balloon is attached to the tube by gluing or ultrasonic welding.
  • along said at least an inner circumference said balloon substantially sealingly contacts said tube.
  • along said at least an outer circumference the balloon is attached to said sleeve.
  • the balloon is attached to the sleeve by gluing or ultrasonic welding. In some embodiments, along said at least an outer circumference said balloon substantially sealingly contacts said sleeve. In some embodiments, the balloon is formed integrally with said tube. In some embodiments, the balloon is formed integrally with said sleeve.
  • the balloon contacts the inner surface of said sleeve along not more than 50% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 40% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 30% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 20% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 10% of said inner surface.
  • the length of said balloon along the longitudinal axis thereof is less than the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than half the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than 40% of the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than 30% of the length of said sleeve along the longitudinal axis thereof.
  • the length of said balloon along the longitudinal axis thereof is not more than 20% of the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than 10% of the length of said sleeve along the longitudinal axis thereof.
  • the ratio of the length of said balloon along the longitudinal axis thereof to the length of said sleeve along the longitudinal axis thereof is less than 1:2. In some embodiments, the ratio of the length of said balloon along the longitudinal axis thereof to the length of said sleeve along the longitudinal axis thereof is not more than 1:5. [0023] In some embodiments, the balloon is inflated. In some embodiments, the average pressure exerted by the outer surface of said sleeve against the wall of said trachea over a period of one minute does not exceed 25 mm Hg.
  • the pressure exerted by the outer surface of the sleeve against the wall of the trachea is less than 50 mg Hg for over 50% of the breathing cycle of the intubated patient.
  • the pressure of the cuff balloon is maintained fixed at pressure higher than 25mm mercury independent of the human respiratory cycle during intubation.
  • the balloon is not inflated and an outer circumference of said balloon is sealingly adhered to the inner surface of said sleeve.
  • the cuff is a flexible membrane.
  • the flexible membrane is generally disk-, ring- or cone-shaped.
  • the membrane contacts the tube and along at least an outer circumference of the membrane the membrane contacts the inner surface of the sleeve. In some embodiments, along said at least an inner circumference the membrane is attached to said tube. In some embodiments, the membrane is formed integrally with the tube. In some embodiments, the membrane is attached to the tube by gluing or ultrasonic welding. In some embodiments, along said at least an inner circumference said membrane substantially sealingly contacts said tube. In some embodiments, along said at least an outer circumference the membrane is attached to said sleeve. In some embodiments, the membrane is attached to the sleeve by gluing or ultrasonic welding.
  • the membrane substantially sealingly contacts said sleeve.
  • the membrane is formed integrally with said sleeve.
  • the membrane is adapted to allow movement of the tube along the longitudinal axis thereof without causing movement of the sleeve, while maintaining contact with the sleeve.
  • the tracheal tube is an endotracheal tube. In some embodiments, the tracheal tube is a tracheostomy tube.
  • a portion of the tube which is not in contact with the cuff can extend and/or contract along the longitudinal axis of the tube.
  • the portion is has an accordion-like or helical structure.
  • the method further comprises inserting into the trachea an aeration structure for blowing air through the region of the trachea proximal to the cuff, the aeration structure having an outlet positioned on the proximal side of the cuff.
  • the aeration structure is a secondary lumen embedded in the wall of the tracheal tube.
  • the method shows a decrease in the occurrence of at least one of the following: ventilation associated pneumonia; anoxia; erosion of the mucosa; destruction of tracheal cartilage rings; segmental tracheomalacia with dilatation of the trachea; full thickness erosion, optionally with perforation of the inominate artery anteriorly or posteriorly into the esophagus; and late complications of tracheal stenosis.
  • a tracheal tube system comprising: a tracheal tube having a distal end which is insertable into a trachea and a proximal end; a sleeve through which said tracheal tube passes, said sleeve having an inner surface which faces said tracheal tube and an outer surface and proximal and distal ends which correspond to the proximal and distal ends, respectively, of said tracheal tube; and a cuff which contacts at least a portion of the outer surface of said tracheal tube and at least a portion of said inner surface of said sleeve in a manner which substantially creates a seal between the distal and proximal ends of the inner surface of said sleeve and the distal and proximal ends of the outer surface of said tracheal tube.
  • a system comprising: (a) a tracheal tube; (b) a sleeve which is sized to fit in a human trachea in the region between the larynx and the carina, the inner diameter of the sleeve being larger than the outer diameter of the tracheal tube; and (c) a cuff which traverses the region between the tracheal tube and the sleeve; the tracheal tube, the sleeve and the cuff being configured such than when deployed in a human trachea, the cuff, in combination with the tracheal tube and the sleeve, substantially prevents leakage to the lungs of fluids from the region of the trachea proximal to the larynx.
  • the sleeve is sized and shaped to contact the tracheal wall. In some embodiments, the sleeve has a substantially circular cross-section. In some embodiments, the maximum diameter of the sleeve is not more than about 2.5 cm. In some embodiments, the sleeve has a non-circular cross section. In some embodiments, the sleeve is sized and shaped to contact the tracheal wall in a manner which substantially seals the lungs from the pharynx. In some embodiments, the sleeve is of a length that fits between the larynx and the carina. In some embodiments, the sleeve has a length of from 2 to 8 cm.
  • the sleeve is located in a human trachea and the distal end thereof is positioned 2 to 6 cm above the carina. In some embodiments, the average radius between the outer surface of the tube and inner surface of the sleeve is at least 1 mm.
  • the tube is of substantially circular cross section and inner diameter of the tube is from 6 to 14 mm.
  • the inner diameter of the tube is at least 6 mm.
  • the inner diameter of the tube is at least 7 mm.
  • the inner diameter of the tube is at least 8 mm.
  • the inner diameter of the tube is at least 9 mm.
  • the inner diameter of the tube is at least 10 mm.
  • the inner diameter of the tube is at least 11 mm.
  • the inner diameter of the tube is at least 12 mm.
  • the inner diameter of the tube is at least 13 mm.
  • the inner diameter of the tube is 14 mm.
  • the tube is of substantially circular cross section and outer diameter of the tube is from 8 to 16 mm. In some embodiments, the outer diameter of the tube is at least 8 mm. In some embodiments, the outer diameter of the tube is at least 9 mm. In some embodiments, the outer diameter of the tube is at least 10 mm. In some embodiments, the outer diameter of the tube is at least 11 mm. In some embodiments, the outer diameter of the tube is at least 12 mm. In some embodiments, the outer diameter of the tube is at least 13 mm. In some embodiments, the outer diameter of the tube is at least 14 mm. In some embodiments, the outer diameter of the tube is at least 15 mm. In some embodiments, the outer diameter of the tube is 16 mm.
  • the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:16 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:15 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:14 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:13 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:12 to 25:8.
  • the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25: 11 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:10 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:9 to 25:8. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:16 to 25:9. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:16 to 25:10.
  • the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25: 16 to 25: 11. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:16 to 25:12. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:16 to 25:13. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25: 16 to 25: 14. In some embodiments, the ratio of the average outer radius of the sleeve to the outer radius of the tube is from 25:16 to 25:15.
  • the sleeve is substantially rigid in its axial direction along at least 50% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 60% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 70% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 80% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along at least 90% of its length. In some embodiments, the sleeve is substantially rigid in its axial direction along substantially all of its length. [0036] In some embodiments, the sleeve is in the form of a rolled sheet.
  • the sleeve comprises a plurality of rods which impart stiffness along the axial direction of the sleeve.
  • the rods are connected at alternate ends by flexible connectors.
  • the rods are arranged generally parallel to one another and are spaced from each other by flexible segments.
  • the sleeve is a radially expandable sleeve which is in the expanded state. In some embodiments, the sleeve is biased toward an expanded state. In some embodiments, the sleeve is biased toward an unexpanded state. In some embodiments, the sleeve comprises a shape memory material or a thermoplastic material which can be returned to an unexpanded state.
  • the sleeve comprises one or more covering layers which are impermeable to mucous, saliva and other bodily fluids.
  • at least one covering layer is made of latex, polyurethane or butyl rubber.
  • the sleeve comprises a deformable outer layer.
  • the deformable out layer is filled with a fluid.
  • the fluid is selected from air and a gel.
  • the cuff is a balloon, the length of which is less than the length of said sleeve.
  • the balloon is generally ring- or donut-shaped.
  • along at least an inner circumference of the balloon the balloon contacts the tube and along at least an outer circumference of the balloon the balloon contacts the inner surface of the sleeve.
  • along the at least an inner circumference the balloon is attached to said tube.
  • the balloon is attached to the tube by gluing or ultrasonic welding.
  • along said at least an inner circumference said balloon substantially sealingly contacts said tube.
  • along said at least an outer circumference the balloon is attached to said sleeve.
  • the balloon is attached to the sleeve by gluing or ultrasonic welding. In some embodiments, along said at least an outer circumference said balloon substantially sealingly contacts said sleeve. [0042] In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 50% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 40% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 30% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 20% of said inner surface. In some embodiments, the balloon contacts the inner surface of said sleeve along not more than 10% of said inner surface.
  • the length of said balloon along the longitudinal axis thereof is less than the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than half the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than 40% of the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than 30% of the length of said sleeve along the longitudinal axis thereof.
  • the length of said balloon along the longitudinal axis thereof is not more than 20% of the length of said sleeve along the longitudinal axis thereof. In some embodiments, the length of said balloon along the longitudinal axis thereof is not more than 10% of the length of said sleeve along the longitudinal axis thereof.
  • the ratio of the length of said balloon along the longitudinal axis thereof to the length of said sleeve along the longitudinal axis thereof is less than 1:2. In some embodiments, the ratio of the length of said balloon along the longitudinal axis thereof to the length of said sleeve along the longitudinal axis thereof is not more than 1:5. [0045] In some embodiments, the balloon is inflated. In some embodiments, the system is located in a trachea and the average pressure exerted by the outer surface of said sleeve against the wall of said trachea over a period of one minute does not exceed 25 mm Hg.
  • the system is located in a trachea and the pressure exerted by the outer surface of the sleeve against the wall of the trachea is less than 50 mg Hg for over 50% of the breathing cycle of the intubated patient.
  • system is located in a trachea and the pressure of the cuff balloon is maintained fixed at pressure higher than 25mm mercury independent of the human respiratory cycle during intubation.
  • the balloon substantially immobilizes the tube relative to the sleeve in the longitudinal direction thereof.
  • the balloon is not inflated and an outer circumference of said balloon is sealingly adhered to the inner surface of said sleeve.
  • the cuff is a flexible membrane.
  • the flexible membrane is generally disk-, ring- or cone-shaped.
  • along at least an inner circumference of the membrane the membrane contacts the tube and along at least an outer circumference of the membrane the membrane contacts the inner surface of the sleeve.
  • along said at least an inner circumference the membrane is attached to said tube.
  • the membrane is attached to the tube by gluing or ultrasonic welding.
  • the membrane is formed integrally with the tube.
  • along said at least an inner circumference said membrane substantially sealingly contacts said tube.
  • along said at least an outer circumference the membrane is attached to said sleeve.
  • the membrane is formed integrally with the sleeve. In some embodiments, the membrane is attached to the sleeve by gluing or ultrasonic welding. In some embodiments, along said at least an outer circumference said membrane substantially sealingly contacts said sleeve. In some embodiments, the membrane is adapted to allow movement of the tube along the longitudinal axis thereof without causing movement of the sleeve, while maintaining contact with the sleeve.
  • a portion of the tube which is not in contact with the mediating structure can extend and/or contract along the longitudinal axis of the tube.
  • the system further comprises an aeration structure having a distal end which opens near the cuff on the proximal side of the cuff and a proximal end that opens near the proximal end of the tube.
  • the aeration structure is a secondary lumen embedded in the wall of the tracheal tube.
  • the tracheal tube is an endotracheal tube. In some embodiments, the tracheal tube is a tracheostomy tube.
  • a tracheal tube having an inflatable cuff, wherein a portion of the tube which is not in contact with the cuff can extend and/or contract along the longitudinal axis of the tube.
  • the portion is has an accordion-like or helical structure.
  • a tracheal intubation kit comprising: (a) at least one of (i) a tracheal tube having a distal end which is insertable into a trachea and a proximal end; (ii) a sleeve through which said tracheal tube can pass, said sleeve having an inner surface and an outer surface and proximal and distal ends which correspond to the proximal and distal ends, respectively, of said tracheal tube; and (iii) a cuff which is positionable between the tube and sleeve to contact at least a portion of the outer surface of said tracheal tube and at least a portion of said inner surface of said sleeve in a manner which substantially creates a seal between the distal and proximal ends of the inner surface of said sleeve and the distal and proximal ends of the outer surface of said endotrache
  • a tracheal intubation kit comprising a system as described herein and instructions instructing a user how to deploy said system in the trachea of a human patient.
  • a tracheal intubation kit comprising (a) at least one of (i) a tracheal tube having a distal end which is insertable into a trachea and a proximal end; (ii) a sleeve through which said tracheal tube can pass, said sleeve having an inner surface and an outer surface and proximal and distal ends which correspond to the proximal and distal ends, respectively, of said tracheal tube; and (iii) a cuff which is positionable between the tube and sleeve to contact at least a portion of the outer surface of said tracheal tube and at least a portion of said inner surface of said sleeve in a manner which substantially creates a seal between the distal and proximal ends of the inner surface of said sleeve and the distal and proximal ends of the outer surface of said endotracheal or
  • FIG. 1 illustrates a typical design and employment of an endotracheal tube (ETT), as known in the art (in this case taken from Fig. 2A of U.S. patent no. 6,843,250);
  • ETT endotracheal tube
  • FIG. 2 presents drawings showing schematically elements of an endotracheal tube with sleeve, in accordance with some embodiments of the invention
  • Fig. 3 diagrams forces operating at the contact between the balloon cuff and the sleeve support;
  • Fig. 4 illustrates the characteristic pooling of fluids both as known in the art and in accordance with some embodiments of the present invention;
  • FIG. 5 illustrates an embodiment of suction elements on the sleeve
  • FIG. 6 illustrates a prior art ETT balloon with a unique cup shape (taken from US
  • Fig. 7 illustrates the difference in the influence of air pressure on the sealing of intubation elements against the trachea wall in an embodiment of the present invention in comparison to the prior art
  • FIG. 8 illustrates additional embodiments of the present invention
  • FIG. 9 illustrates a sleeve structure in accordance with some embodiments of the invention.
  • Fig. 10 shows force vectors contributions of the bare sleeve pressure and the cuff balloon pressure
  • FIG. 11 illustrates some embodiments of the sleeve structure
  • Fig. 12 illustrates another embodiment useable in the sleeve structure.
  • Fig. 13 illustrates a spiral folded sleeve in accordance with embodiments of the present invention
  • FIG. 14 illustrates a cross section of a sleeve in accordance with some embodiments of the invention.
  • FIG. 15 illustrates an embodiment of the invention where the sleeve is connected to the
  • Fig. 16 illustrates an embodiment of the invention having a springy mid- section of the endotracheal tube below the level of the vocal cords;
  • Fig. 17 illustrates an embodiment of the invention having a springy mid-section of the endotracheal tube above the level of the vocal cords;
  • Fig. 18 illustrates an embodiment of the invention having air outlets opening from a second lumen at a position below the level vocal cords;
  • Fig. 19 illustrates a system in accordance with some embodiments of the invention.
  • sleeve element 220 when deployed, it is deployed in a such as way that a portion of the ETT contacts a "sleeve" element via a mediating element, thus creating a seal within the sleeve and between the lungs and the oral cavity.
  • Figs. 2a and 2b show in cut-away perspective and cross-sectional view along the longitudinal axis, respectively, an example of such a sleeve element 220, constructed and operative in accordance with embodiments of the present invention, deployed in a trachea 210. As shown, sleeve element 220 is of quasi-cylindrical shape, and of length L s .
  • sleeve element 220 is an expandable sleeve element in an expanded state; such expandable sleeve elements will be discussed in greater detail below.
  • the outer surface of sleeve element 220 is in contact with the tracheal tissue; as shown in Fig. 2b, which in addition to sleeve element 220 also shows an endotracheal tube 260 having a balloon cuff 250, a sealing contact is established between a portion of the inner surface of sleeve 220 and balloon cuff 250, which is attached to and inflated around ETT 260.
  • sleeve 220 on trachea 210 which may itself arise from pressure exerted by balloon cuff 250 on sleeve element 220
  • the region 265 between the trachea and the ETT 260 hereinafter referred to as the "interstitial region"
  • a seal is created between the lungs on the distal end of sleeve element 220 and the oral cavity on the proximal end of sleeve element 220, thus ensuring that air can be forced into and withdrawn from the lungs through the ETT, as air will be unable to pass into or out of the lungs through the interstitial region.
  • the seal between sleeve element 220 and ETT 260 confines the collected fluids to the region within the sleeve, away from contact with the tracheal wall tissue.
  • the use of a sleeve together with an ETT may in some places be referred to as "sleeve-supported ETT".
  • sleeve or "sleeve element” is used so as to intuitively call to mind the image of a generally cylindrical shaped element which can be expanded to press snugly against the inner wall of biological tubes, such as the trachea.
  • a sleeve element may thus be pronounced of stent devices, but this mental association is not meant to limit the sleeve elements discussed herein to the shapes or designs or constructions of stent devices presently known in the art or to imply that currently known stent devices are necessarily usable in accordance with embodiments of the present invention. Further properties of sleeve elements in accordance with embodiments of the present invention will be discussed further below.
  • the sealing between the ETT and the sleeve element is effected by a cuff balloon
  • such sealing can be effected in other ways as well, for example by physical attachment of the mediating element to the outer surface of the ETT on the one hand and to a portion of the inner surface of the sleeve on the other hand, e.g. a deformable membrane such as an elastic diaphragm (as will be discussed in more detail with respect to Fig. 15), or via an iris closing from the sleeve.
  • part of the inner surface of sleeve element 220 has a ring-like region 230 of radius R 1n (diameter 2R 1n ) and rigid support along length L 1n , wherein L 1n ⁇ L s .
  • 230 protrudes outwardly from the inner surface of sleeve element 220 this need not be the case, and 230 may be flush with the inner surface of sleeve element 220.)
  • the longitudinal rigidity along the length L 1n enables sleeve element 220 to disperse the pressure applied by balloon cuff 250 over a wider area, thus mitigating the effective pressure applied to the trachea; but radial flexibility along radius R 1n , up to a predetermined maximum radius R in - ma ⁇ , is allowable. It will be appreciated that although the cuff balloon 250 shown in Fig.
  • cuff balloon 250 could have any other suitable shape, such as a donut or ring shape, including an oblong donut shape such as is shown for cuff balloon 850 in Fig. 8.
  • the ETT cuff balloon when inflated, has a contact length L t , a i with the sleeve support; in general, L 1n > L t , a i.
  • FIG. 2b A novel property of construction shown in Fig. 2b is a mediating degree of freedom between the pressure exerted by the balloon cuff and the pressure exerted on the trachea wall tissue is obtained.
  • the length L 1n is assumed to be substantially rigid, corresponding generally to the length L s of the sleeve, but the length of the rigid portion, L 1n , may be less than the length of the entire sleeve, L s .
  • emplacement of the balloon cuff 250 within a sleeve 220 also ensures that the seal between the sleeve and the trachea increases during inspiration, as air pressure on the distal side of the cuff (the nearer the lungs) presses against both the balloon cuff and the sleeve.
  • airway pressure fluctuates with ventilatory requirements of the lungs, this pressure is transmitted to the inner surface of the sleeve and increases the seal between the sleeve and the tracheal wall.
  • Figs. 10a and 10b which show cross-sections of an expandable sleeve element taken perpendicular to the longitudinal axis, in addition to mediating a lower pressure from the cuff balloon to the trachea, an additional degree of freedom may be provided in the form of the inherent tension in sleeve element 220. This tension may be chosen to affect the total pressure P t mediated to the trachea.
  • P t can still be substantially lower than Pbai-
  • the bare sleeve has a compression tension to contract away from the trachea wall.
  • Fig. 10b The situation of Fig. 10b can be realized when the sleeve is delivered in a non-compressed, weakly compressed, or even slightly stretched state (with respect to a free independent sleeve rest configuration). Then the sleeve is elastically expanded in diameter under the pressure force of the inflating ETT cuff balloon. When the balloon is deflated, the contracting elastic forces of the sleeve cause the sleeve to recollapse away from the trachea wall, without need for special additional re-collapse tools or force elements.
  • the radius of expansion of the sleeve may be limited, so that the inner radius of the sleeve are limited to a maximum radius R in - max .
  • This can provide a protective decoupling of the balloon pressure from the sleeve pressure on the trachea beyond the maximum inner surface radius of the sleeve.
  • the balloon can be inflated to its desired high pressure, while the sleeve, if separately inflatable (see description below), can be independently inflated to a different pressure.
  • any construction of the sleeve element that facilitates radial expansion thereof may be realized in alternative embodiments of the invention that take advantage of the controlled difference and relative independence between the sealing pressure P ba i applied within the cuff balloon of the ETT tube and the associated pressure P bs exerted by the sleeve element on the trachea tissue.
  • This enables the total pressure P t of the sleeve element on the trachea wall tissue to be maintained below 25 mm mercury at most times during intubation, and thus tissue anoxia can be avoided even for extended intubation periods.
  • the pressure decoupling between the ETT cuff balloon and the trachea tissue means that it is unnecessary to dynamically regulate the balloon pressure, so that the balloon pressure can be set to provide an adequate level of sealing, to prevent leak of fluids past the cuff (seeping through the contact between the cuff balloon and the sleeve).
  • various costs and complications associated with dynamic trachea pressure-sensing and cuff pressure regulation of some prior art devices can be eliminated.
  • high-pressure, low- volume (HPLV) cuff balloons may be used instead of the presently preferred low-pressure, high- volume (LPHV) balloons.
  • LPHV low-pressure, high- volume
  • the inner surface of the sleeve may be roughened (e.g., by circular ribs) so that fluids are further obstructed from easily flowing into the lungs.
  • FIG. 4a use of a sleeve element 220 in accordance with embodiments of the invention enables fluids 410 to pool and collect away from the trachea wall tissue 210; this is in sharp contrast to the known art of ETT tubes, in which, as illustrated in Fig. 4b, curvature of the inflated cuff 250 tends to cause fluids 410 to collect exactly at the highest risk location, viz. near the trachea skin tissue 210. As shown in Fig.
  • the fluids collect at the bottom of a toroidal-like space, the sides of which are formed by the walls of the sleeve 220 and the ETT 260, and a sealing bottom is formed by the inflated cuff balloon 250. Consequently, even if there are momentary breaks in the seal between the trachea tissue 210 and the sleeve 220, there are no significant volumes of fluids present at the interface between sleeve 220 and trachea 210 which can leak down into the lungs. Such an arrangement may also make the ETT/cuff/sleeve arrangement less sensitive to the occasional cough or other violent movement of the trachea than the ETT/cuff systems presently in use.
  • suction elements 420 which are connected to an external suction tube, not shown, that for example exits the patient's mouth
  • suction elements 420 often cannot reach the contact location between the balloon 250 and the trachea tissue 210 where fluids 410 naturally collect due to the force of gravity, and where suction is most needed.
  • the suction device elements 420 and 530 can be placed at locations on the ETT or the sleeve that enable them to collect a larger percentage of the fluids that collect than is the case with the types of devices illustrated in Fig. 4b.
  • Figs. 11 and 12 show embodiments in which a core skeleton, which provides longitudinal rigidity but allows for expansion radially, is covered by an impermeable sheet of malleable polymer material.
  • Figs, l ie and Hd show a sleeve structure 1450, which is made from a skeleton 1400 encased in outer polymer layer 1492 and an optional inner polymer layer 1490; it is outer surface 1480 that makes contact with the trachea.
  • Fig. l ie shows the sleeve of Fig.
  • the sleeve skeleton 1400 is in the form of linked stiff rods 1430.
  • the links 1432 (shown in Figs. 11a and l ib but not Figs, l ie or Hd, which show only part of rods 1430) are flexible and alternate between top and bottom connection of neighboring rods.
  • the stiffness of the rods 1430 provides sleeve 1400 with the rigidity along the longitudinal axis, while the links 1432 enable radial expansion and elastic return forces.
  • the length of each rod 1430 extends through more than 50% and more preferably through substantially the entire length of the sleeve. It will be appreciated that a break or elastic mid-section in the rods (akin to what is commonly found in stent constructions) would reduce the overall axial stiffness of the sleeve, resulting in a less even distribution of pressure along the sleeve on the trachea wall due to pressure exerted on the sleeve by a cuff balloon, and therefore rods 1430 are formed without such breaks or elastic midsections.
  • links 1432 are in an open configuration, then a compressed sleeve held in place by a restraining force would self-expand upon release of the restraining force as the links return to their relaxed, open configuration. Conversely, if the free state of the links is relatively closely compact, then the sleeve will radially expand only under radial force (e.g., exerted by the cuff balloon) and will self contract upon relaxing of the radial force (e.g., upon deflation of the cuff balloon).
  • radial force e.g., exerted by the cuff balloon
  • Fig. 12 shows a series of rods 1530, which are similar in construction to rods 1430, and which have flexible end pieces 1532 analogous to pieces 1432, and can be incorporated into a sleeve in like manner, but in Fig. 12 there are two sets of connected rods, providing additional rigidity along the longitudinal axis.
  • core skeleton 1400 while encased between two polymer layers or covered with a single outer layer, is not glued or adhered to the polymer layer(s), and instead has some freedom of movement relative to the encasing layer(s), thus facilitating radial expansion.
  • the polymers may be elastic, e.g. latex, to facilitate expansion of the sleeve.
  • FIG. 9a and 9b Another construction that can be used to simultaneously obtain longitudinal rigidity and radial flexibility (LRRF) in the sleeve is shown in Figs. 9a and 9b, which correspond to Figs. 2a and 2b.
  • Fig. 9a and 9b Another construction that can be used to simultaneously obtain longitudinal rigidity and radial flexibility (LRRF) in the sleeve is shown in Figs. 9a and 9b, which correspond to Figs. 2a and 2b.
  • FIG. 9a shows that spaced intermittently along sleeve 220 are a plurality of rigid sections 1230 (which may be, for example, rod-like structures, or stiff plates), aligned with the longitudinal axis of the sleeve, and which are interspersed with elastic sections 1235.
  • the alternating rigid/elastic sections can be integrated into sleeve 220, which also touches trachea wall tissue on its outer side.
  • the alternating rigid/elastic sections can be inserted as an independent mediating element between the cuff balloon and a sleeve which is elastic in all directions.
  • the local cuff 250 expansion is mediated on the whole length L 1n of the LRRF element 1230 to the outer sleeve element 1220.
  • spiral sleeve structure 1600 has the general form of a sheet 1620 (the sleeve "wall") rolled into a spiral.
  • the sleeve wall 1620 can optionally be constructed entirely or mostly from a sheet of non-stretchable material. Such a spiral sleeve can radially expand by unfolding of the spiral.
  • a spiral sleeve configuration enables the sleeve to provide both a substantially stiff inner surface, i.e. longitudinal rigidity in the direction of the axis of coiling of the sleeve, and flexible radial expansion perpendicular to that axis, to allow the expanded sleeve to conform to the mostly oval but not perfectly cylindrical geometry commonly found in the trachea.
  • the structure of the sleeve wall 1620 can be uniform both along the length and the width of the wall (i.e. both along the axis of coiling and in the sleeve body in the direction of the coiling), e.g. in some embodiments, the inner surface of the sleeve wall 1620 can be made of a non- stretching polymer or a metallic material.
  • the structure of the sleeve wall 1620 can be non-uniform in the direction of the coiling of the sleeve, e.g., in some embodiments, the inner wall of the sleeve wall 1620 can be made of alternating rod- like sections of stiff polymer or metallic material 1630, interspersed by more pliable or elastic regions.
  • the sleeve wall can take the form of a core skeleton (e.g., as illustrated in Figs. 11 and 12) covered by an impermeable thin layer.
  • Typical spiral sleeve designs have imperfect sealing at both terminii of the spiral sheet parallel to the axis of coiling (see e.g. ends 1622 and 1623 in Fig. 13c), and thus, there will be risk of fluids leaking along these ends when such a sleeve is used in combination with a balloon- cuffed ETT in accordance embodiments of the present invention.
  • the spiral sheet terminii e.g. 1622 and 1623
  • the spiral sheet terminii are constructed with a tapering geometry, such the their tips continue smoothly to the adjacent sheet surface.
  • the sleeve 1600 expand evenly along both the top and bottom ends of coil. This can be enabled by the use of tracking attachments such as 1641 and 1642, which, when placed at both ends of the coiled sleeve, keep the sleeve sheet moving parallel to the longitudinal axis of coiling throughout the sleeve expansion motion.
  • the pressure to cause the coiled sleeve to expand radially can optionally be exerted by inflation of the ETT cuff balloon.
  • Fig. 14 The trachea has the structure of a series of rings arranged one on top of the other, and, as explained earlier, has a cross-section which is not perfectly circular. Consequently, the trachea wall tissue has a non-uniform, wavy geometry along its length and a non-circular cross section. An expanding, rigidly flat sleeve will exert a non-uniform pressure along the trachea tissue.
  • the sleeve in order to conform better to the trachea tissue, has a compressible outer layer cover, which may be e.g. inflatable, or filled with a foam or gel material, or constructed from a deformable material.
  • sleeve 1700 schematically shows a cross sectional view of a sleeve embodiment 1700, shown perpendicular to the longitudinal axis of the sleeve.
  • the inner portion 1730 provides axial rigidity.
  • sleeve 1700 also has an outer portion 1720, which is compressible and pliable along most of its surface area.
  • Outer portion 1720 may be, for example, an inflatable bag, or it may be a thin, gel-filled bag. The pliable nature of outer portion 1720 enables it to conform to the trachea tissue surface.
  • outer portion 1720 improves the sealing of the sleeve and the trachea in comparison to embodiments that lack the outer portion, and it functionally distributes more uniformly the pressure exerted by the sleeve on the non-uniform geometry of the trachea wall tissue.
  • inner and outer portions 1720 and 1730 are attached to one another, e.g. by gluing or ultrasonic welding. In other embodiments, the portions 1720 and 1730 are only attached to each other in some locations, but are not glued or connected over the full contact surface between them.
  • the outer layer 1720 is inflatable, means for inflating 1720, similar to those used for inflating the ETT cuff balloon, are provided.
  • outer portion 1720 is made of a compressible foam or rubber material.
  • a typical ETT tube has a well-defined directionality for placement into a human trachea.
  • ETT tubes are axially arched towards the frontal side of the patient.
  • ETT cuff balloons presently in use are circularly symmetric, even though the cross-section of the human trachea is not circularly symmetric.
  • the anterior side of the trachea has a semicircular arc shape delineated by cartilage, the posterior side of the trachea may be quite flat and even bulge in toward the trachea center.
  • the sleeve is made so that its radial expansion properties are asymmetrical, e.g.
  • an asymmetric sleeve can be obtained in an expandable sleeve where its outer layer is constructed with non-uniform thickness.
  • the outer layer is made of an elastic material (such as polyurethane, latex, or butyl rubber)
  • the coefficient of elasticity of such a layer is dependent on the thickness thereof; a thicker layer is stiffer than a thinner one made of the same material. Therefore, in some embodiments, the outer layer of an expandable sleeve can be made thicker on one side and thinner on the other side.
  • asymmetric sleeves transmit varying contact pressures to the trachea surface tissue.
  • Fig. 8 depicts a configuration similar to that shown in Figs. 2b and 9b, but here the thickness of the sleeve 820 is non-uniform.
  • sleeve 820 is thin near its ends and thicker in the middle section. The thickness increase towards the center is preferably increased gradually, such that a smooth slant is created. Consequently, fluids 410 moving down the trachea collect near the ETT 860 and away from the trachea tissue 210.
  • the ETT cuff balloon 850 when fully inflated, has a diameter smaller than the trachea diameter. Instead, cuff 850 is inflated so that the diameter thereof fits the diameter 2R 1n of the inner surface 830 of sleeve 820 at its mid-section.
  • sleeve 820 may be constructed so that sleeve 820 is itself composed of two concentric expanding sub-sleeves.
  • one sub-sleeve may delimit the inner surface 830, while the second sub-sleeve defines the outer surface which contacts, and preferable fits to the curvature of, the trachea wall tissue.
  • the volume between these first and second sub-sleeves may be constituted from, for example, an inflatable membrane or an expanding gel or foam material, to give the full form and geometry of the sleeve 820.
  • the sleeve (such as sleeve 820) is initially positioned in the trachea in a compressed or otherwise unexpanded state. Upon reaching the desired location, the sleeve is caused to expand until its outer surface presses against the trachea wall tissue 210. The expanded sleeve 820 is set so that over time the pressure it exerts on the trachea tissue 210 is less than 25 mm Hg.
  • means of expanding the sleeve may constitute fluid or gas inflation means, expanding rings, or by analogy to methods known in the art of stent expansion.
  • the ETT cuff balloon 850 may be inflated, independently of the sleeve 820, to a pressure higher than 25 mm Hg against the inner surface
  • the sleeve such as sleeve 820, may include antibacterial elements, such as an antibacterial coating, or an antibacterial drug(s) that is slowly released from the sleeve.
  • antibacterial elements such as an antibacterial coating, or an antibacterial drug(s) that is slowly released from the sleeve.
  • the ETT cuff balloon can be inflated to a steady high pressure, without risk of tissue anoxia and other related complications in the tracheal tissue.
  • the pressure of the sleeve on the trachea wall tissue may be dynamically regulated independently from the ETT cuff.
  • the sleeve element incorporates a re-collapse mechanism in order to enable its extraction at the end of intubation treatment.
  • This may take the form, for example, of the sleeve being biased toward the collapsed state, such that when the cuff balloon is deflated, the sleeve collapses (as discussed above); other illustrative embodiments include the use of shape memory material in the formation of the sleeve, which facilitates the return of the sleeve to a collapsed state; or a thermoplastic resin that is worked in such a way that upon heating, the sleeve collapses.
  • shape memory material in the formation of the sleeve, which facilitates the return of the sleeve to a collapsed state
  • a thermoplastic resin that is worked in such a way that upon heating, the sleeve collapses.
  • the sleeve may be incorporated for delivery on top of the ETT itself.
  • the sleeve may be expanded, at least partially, by inflation of the ETT cuff itself.
  • Variations of such embodiments include direct attachment of the sleeve to the ETT cuff balloon along a circumference of the balloon. Such an arrangement improves the sealing between the balloon and renders the sealing independent of pressure.
  • the sleeve may be placed in the trachea prior to the insertion of the ETT, using means analogous to those used in the art of stent delivery and placement.
  • the ETT may be emplaced thereafter, in a manner that facilitates creation of a seal between the ETT and sleeve, for example by positioning the cuff balloon so that when inflated, it contacts the inner surface of the sleeve.
  • a sleeve 1920 is connected to ETT 260 via a thin, flexible membrane 1925, which is attached, e.g. by gluing or ultrasonic welding, to both the ETT along an outer circumference thereof and to the sleeve along an inner circumference thereof.
  • Membrane 1925 may also be formed integerally with the ETT and/or the sleeve. Because membrane 1925 is easily deformable, in principle a significant freedom of up/down movement of the tube 260 relative to the trachea wall 210 and relative to sleeve 1920, without concomitant movement of sleeve 1920, is enabled, depending on the length of membrane 1925. Such relative movement is illustratively represented by the difference between Figs. 15a and 15b, wherein the upward movement of the tube 260 has caused a change in the rest shape of the connecting membrane 1925 but without dragging up the sleeve 1920.
  • the membrane 1925 may or may not itself be inflatable.
  • Membrane 1925 may have any suitable shape that allows movement of the tube relative to the trachea wall and the sleeve, such as a disk, ring, or cone shape.
  • FIG. 16a illustrates the principle according to which a flexible tube midsection 2065 (depicted in the drawing as an accordion-like part) is capable of stretching or expanding longitudinally. This allows the distance between upper tube section 2061 lower tube section 2060 to vary. Hence, forced movement of the top tube section 2061 will not necessarily force a movement of the bottom tube section to which the balloon and/or the sleeve are connected.
  • Fig. 16b illustrates an embodiment in which the flexible mid section 2065 is formed from a spring-like skeleton which is wrapped within an impermeable but stretchable membrane.
  • Fig. 17a illustrates an embodiment in which a flexible mid-section 2165 is placed below the vocal cords and/or a flexible mid-section 2175 is placed above the vocal cords. Either of these midsections can be formed from a spring-like skeleton which is wrapped within an impermeable membrane; such membranes are indicated by elements 2166 and 2176, respectively, in Fig. 17a.
  • Fig. 17b illustrates an embodiment in which flexible mid section 2165 formed via a helical cut in a regular tube wall, i.e. spring-like element 2165 is made of the same material as the ETT itself, and there is an unbroken continuation of the tube material between the lower section 2160 and upper section 2161 through the springy mid-section 2165, without any additional bonding material.
  • FIG. 18 illustrates an ETT embodiment with air outlets 2280 positioned on the side of the tube. Outlets 2280 are preferably placed below the vocal cords.
  • the structure of outlets 2280 structure is reminiscent of the structure suction inlets 420, and can be similarly fed by a secondary lumen embedded in the ETT wall (not shown but known in the art with respect to suction inlets).
  • One or more outlets 2280 can be implemented.
  • the timing of air blowing through outlets 2280 is correlated with the rhythm of air inhalation/exhalation ventilation of the patient.
  • the blowing of air from outlets is 2280 is correlated with the peak of ventilation positive pressure.
  • FIG. 19 illustrates an intubation system in accordance with embodiments of the present invention, that implements a particular combination of features.
  • the general approach is to have an option to intubate a patient first with a conventional looking ETT with cuff balloon only (Fig. 19a), and then in an independent treatment step to add a sleeve element (Fig. 19b).
  • Such an arrangement is useful, for example, where intubation is necessary, but it is unknown at the time if such intubation will be short-term or long-term.
  • the patient is first intubated with a conventional cuff balloon ETT, viz. without the sleeve (e.g., during surgery), and a conventional cuff 250 is inflated to a functional level, as is known in the art.
  • a conventional cuff 250 is inflated to a functional level, as is known in the art.
  • the patient is brought into the ICU, there is an option to insert sleeve 1920 into the trachea, over balloon cuff 250.
  • the detachable top 2395 is quickly opened, the sleeve is slid over the top of the ETT, and the top 2395 is immediately reconnected in order to continue normal ventilation of the patient.
  • Sleeve 1920 is initially delivered in a compressed configuration of small diameter around the top of the ETT tube.
  • the sleeve is then lowered down the ETT tube to its designated sealing location below the vocal cords.
  • the cuff 250 is decompressed in order to allow the lowering of the sleeve into its final position.
  • the sleeve is expanded (for example, inflated with gas) to snugly press against the trachea wall tissue.
  • the cuff balloon 250 is re-inflated just to assist in maintaining the shape of the sleeve 1920.
  • the ETT system may incorporate a suction port 420 and/or air outlet ports 2280.
  • the ETT system may incorporate dynamic length tube sections 2175 above the vocal cords, and/or 2165 below the vocal cords.
  • tracheal tube will be understood as encompassing endotracheal tubes as well as tracheotomy and tracheostomy tubes
  • tracheal intubation will be understood as encompassing intubation in the trachea using such tubes.

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Abstract

La présente invention concerne des méthodes d’intubation d’un patient qui consistent à déployer un tube trachéal, un manchon et un ballonnet dans une trachée humaine de telle sorte qu’après le déploiement, le tube trachéal passe dans la trachée à travers le manchon, le ballonnet entre en contact avec la surface extérieure du tube trachéal et la surface intérieure du manchon et éloigne le manchon du tube, et la surface extérieure du manchon entre en contact avec la trachée de façon à réaliser une étanchéité dans la région interstitielle se trouvant entre la paroi de la trachée et le tube, entre une partie proximale de la trachée humaine située au-dessus du ballonnet et une partie distale de la trachée humaine située au-dessous du ballonnet. L’invention concerne également d’autres modes de réalisation.
PCT/US2009/062227 2008-10-27 2009-10-27 Méthode et appareil de protection trachéale pendant une ventilation WO2010062603A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PCT/US2010/039881 WO2010151713A2 (fr) 2009-06-24 2010-06-24 Procédé et appareil pour bloquer l'écoulement d'un fluide dans une trachée intubée
EP10792693A EP2445562A2 (fr) 2009-06-24 2010-06-24 Procédé et appareil pour bloquer l'écoulement d'un fluide dans une trachée intubée
US12/823,114 US20110048427A1 (en) 2009-06-24 2010-06-24 Method and apparatus for blocking fluid flow in an intubated trachea
US13/095,361 US20110290246A1 (en) 2009-10-27 2011-04-27 Method and apparatus for protection of trachea during ventilation

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US10859408P 2008-10-27 2008-10-27
US61/108,594 2008-10-27
US21976909P 2009-06-24 2009-06-24
US61/219,769 2009-06-24
US23655309P 2009-08-25 2009-08-25
US61/236,553 2009-08-25
US23815109P 2009-08-29 2009-08-29
US61/238,151 2009-08-29

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PCT/US2010/039881 Continuation-In-Part WO2010151713A2 (fr) 2009-06-24 2010-06-24 Procédé et appareil pour bloquer l'écoulement d'un fluide dans une trachée intubée

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GB2471390A (en) * 2009-06-24 2010-12-29 Venton Medical Ltd Endotracheal tube with sleeve for protection of trachea
WO2015013378A1 (fr) * 2013-07-25 2015-01-29 Medical Instrument Ventures, Llc Canule trachéale à ballonnet
WO2015013380A1 (fr) * 2013-07-25 2015-01-29 Medical Instrument Ventures, Llc Tube trachéal à ballonnet
WO2015013379A1 (fr) * 2013-07-25 2015-01-29 Medical Instrument Ventures, Llc Tube trachéal à ballonnet
CN104602651A (zh) * 2012-03-29 2015-05-06 特鲁德尔医学国际公司 口腔装置及其使用方法
US9526856B2 (en) 2011-12-15 2016-12-27 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for preventing tracheal aspiration
US9750910B2 (en) 2014-08-14 2017-09-05 Coeo Labs Private Limited Systems for automatically removing fluid from multiple regions of a respiratory tract
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WO2018082982A1 (fr) * 2016-11-02 2018-05-11 Tracoe Medical Gmbh Dispositif de respiration artificielle trachéale souple
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GB2471390B (en) * 2009-06-24 2011-10-12 Oron Zachar Breathing intubation method, apparatus and kit
GB2471390A (en) * 2009-06-24 2010-12-29 Venton Medical Ltd Endotracheal tube with sleeve for protection of trachea
US9526856B2 (en) 2011-12-15 2016-12-27 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for preventing tracheal aspiration
CN104602651A (zh) * 2012-03-29 2015-05-06 特鲁德尔医学国际公司 口腔装置及其使用方法
WO2015013380A1 (fr) * 2013-07-25 2015-01-29 Medical Instrument Ventures, Llc Tube trachéal à ballonnet
WO2015013379A1 (fr) * 2013-07-25 2015-01-29 Medical Instrument Ventures, Llc Tube trachéal à ballonnet
WO2015013378A1 (fr) * 2013-07-25 2015-01-29 Medical Instrument Ventures, Llc Canule trachéale à ballonnet
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US10099027B2 (en) 2014-01-24 2018-10-16 Cole Research & Design Oral suction device
US9750910B2 (en) 2014-08-14 2017-09-05 Coeo Labs Private Limited Systems for automatically removing fluid from multiple regions of a respiratory tract
US10695516B2 (en) 2014-08-14 2020-06-30 Jagdish Chaturvedi Systems for automatically removing fluid from multiple regions of a respiratory tract
US11684738B2 (en) 2014-08-14 2023-06-27 InnAccell Technologies Private Limited Systems for automatically removing fluid from multiple regions of a respiratory tract
WO2018082982A1 (fr) * 2016-11-02 2018-05-11 Tracoe Medical Gmbh Dispositif de respiration artificielle trachéale souple
US11324905B2 (en) 2016-11-02 2022-05-10 Tracoe Medical Gmbh Bendable tracheal ventilation apparatus

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