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WO1992003176A1 - Dispositif de regulation de pression utilise en incubation endotracheale par sonde a ballonnet - Google Patents

Dispositif de regulation de pression utilise en incubation endotracheale par sonde a ballonnet Download PDF

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Publication number
WO1992003176A1
WO1992003176A1 PCT/GB1991/001450 GB9101450W WO9203176A1 WO 1992003176 A1 WO1992003176 A1 WO 1992003176A1 GB 9101450 W GB9101450 W GB 9101450W WO 9203176 A1 WO9203176 A1 WO 9203176A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
cuff
disc
valve
regulator
Prior art date
Application number
PCT/GB1991/001450
Other languages
English (en)
Inventor
Donald Munro Miller
Original Assignee
Miller Dent Limited
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
Priority claimed from GB9018774A external-priority patent/GB2248783A/en
Priority claimed from GB919105283A external-priority patent/GB9105283D0/en
Application filed by Miller Dent Limited filed Critical Miller Dent Limited
Priority to AU84494/91A priority Critical patent/AU659802B2/en
Priority to JP3514386A priority patent/JPH06503730A/ja
Publication of WO1992003176A1 publication Critical patent/WO1992003176A1/fr

Links

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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/044—External cuff pressure control or supply, e.g. synchronisation with respiration

Definitions

  • This invention relates to pressure control. It is particularly concerned with the control of pressure within cuffed endotracheal tube systems, and more particularly to a simple apparatus for the maintenance of a constant pressure difference between the pressure inside the cuff of an endotracheal tube and the airway pressure, that is the pressure within the lumen of the endotracheal tube.
  • a tube is inserted into the trachea (referred to as an endotracheal tube) .
  • a relatively large volume soft ring-shaped hollow collapsible bag known as the "cuff" is attached to the outer surface of the endotracheal tube at the tracheal end of the tube.
  • this bag or cuff is inflated with air so that it forms an air tight seal with the mucosal walls of the trachea.
  • the inflated cuff also serves to anchor the tracheal tube within the trachea below the vocal cords.
  • the cuff needs to be inflated to a pressure which is greater than airway pressure in order to prevent leakage of gas past the cuff.
  • the methods commonly used to achieve this frequently result in much higher cuff pressures than the peak inflation pressures used for ventilation.
  • quick and careless initial over- inflation while using a syringe for the purpose the warming of a given volume of air injected into the cuff at room temperature up to body temperature causing the cuff to expand; and the diffusion into the cuff of anaesthetic gases such as nitrous oxide.
  • Excessive cuff pressures may affect perfusion (the blood supply) to the mucosal lining of the trachea causing damage, and may produce complications which may include for example sloughing of the tracheal mucosa, fistula formation, or stenosis.
  • a cuff system should ensure that the lowest cuff pressures necessary are used to achieve the desired objective, namely the sealing of the endotracheal tube .
  • Preferably such as system should automatically hold the cuff pressure just above airway pressure, that is to say one which allows for the variation of airway pressure to be transmitted to the cuff.
  • US 4 850 349 involves a simple device not requiring an external gas supply to power the device, but suffering from the problems related to fixed cuff volume devices mentioned earlier including over-inflation, diffusion of nitrous oxide into the system and failure to compensate for small leaks.
  • the specific device will work only with a limited range of cuff volumes or sizes .
  • US 4 825 862 (Sata et al) describes a more elaborate device than Farahany which does appear to overcome several problems . However it is more elaborate and more bulky, heavy and expensive. It also requires an external high pressure gas source to power the device.
  • a pressure regulator powered by the gas supply source to a breathing system for the maintenance of a constant or substantially constant pressure difference between the cuff and the lumen in a cuffed endotracheal tube during positive pressure ventilation comprising a tubular connecting means for attachment and interposition between the gas supply machine and the breathing system and means for connection to the cuff inflation port of an endotracheal tube, the said regulator comprising a threshold valve for the purpose of generating a substantially constant pressure difference when gases supplying the breathing system flow through the said valve, the pressure differential created by the said threshold valve being either fixed or adjustable, with upstream connecting means for attachment to and in open communication with the inside of the cuff of an endotracheal tube for the purpose of transmitting and maintaining the said upstream pressure to the said cuff above that of the airway pressure by a constant or substantially constant value equal to the threshold valve setting; the regulator being provided with a one-way relief valve allowing gas to flow in the reverse direction, to obviate any danger associated with faulty connection
  • Figure 1 schematically illustrates the relative positions of a system utilising the present invention showing a cuff pressure regulator and its attachment to an anaesthetic machine and breathing system, and its connection to the pilot tube of the endotracheal tube cuff.
  • Figure 2 schematically illustrates a longitudinal section of a regulator forming a first exemplary embodiment of the present invention.
  • Figure 3A schematically illustrates a longitudinal section of a regulator forming a second exemplary embodiment of the present invention.
  • Figure 3B shows an outside view of a part of Figure 3A.
  • Figures 4 to 8 variously show components generally described in connection with Figure 3A.
  • Figure 1 shows an anaesthetic gases supply machine 10 to the outlet 16 of which is attached a cuff pressure regulator 18 of the present invention, which is attached to pilot tube 36 of an endotracheal tube 30 by means of a tubular attachment site 19 and by pipe 20 to breathing system 22.
  • Attached to the breathing system 22 is an endotracheal tube 30 near tracheal end 30A of which is attached endotracheal tube cuff 32, which is maintained inflated with gas, i.e. in a pressurised state, via pilot tube 36.
  • the breathing system 22 may be pressurised intermittently to achieve positive airway pressure ventilation by a ventilating means (in this instance a mechanical ventilator 38) .
  • a ventilating means in this instance a mechanical ventilator 38
  • Figure 2 shows a first example of a pressure regulator for use in connection with the system generally described in connection with Figure 1 to which reference shall occasionally be made.
  • the cuff pressure regulator 9 has a body 9A which is attached to outlet 16 of anaesthetic gas supply machine 10 in Figure 1 by means of inlet channel 13 having a sealing surface 11 forming a gas tight push fit on to the outlet 16 in accordance with the ISO 22mm male to female standard fittings.
  • Anaesthetic supply gases flow through the regulator in the direction of arrow A.
  • Partition 16 serves to separate upstream channel 13 from the downstream outlet channel 14.
  • At least one channel 15 extends through the partition 16 whereby anaesthetic gases flow through the regulator 9.
  • the regulator 9 incorporates a side port 18 providing for open communication with inlet (upstream) channel 13.
  • the port 18 is configured on its outer side to provide a tube attachment 19 for connection to pilot tube 36 in the form of a light non-distensible tubing This provides for matching of changes in gas pressures between inlet channel 13 and the inside of the endotracheal tube cuff 32 ( Figure 1) .
  • a valve 26, comprising a firm disc shaped seat 20 with central axial stabilising rod 23 slides freely through a central and axially arranged channel 35 of an adjustable threaded tube 34 held in position by means of a compression spring 28.
  • Valve seat 20 contains at least one channel 22 through which gases may flow in the reverse direction to the normal flow of arrow A. This would arise if the apparatus was inadvertently connected in the opposite direction to the design recommendation.
  • Upstream sealing edge 21 has a diameter which exceeds the outer border of the more centrally located channels or perforations 22.
  • Flexible disk shaped flap 25 has a diameter which exceeds that of the sealing edge 21 but which is less than the diameter of channel 15. The flap 25 is located on the upstream surface of the valve seat 20 so that, should a reverse flow of gas occur, the flexible flap 25 will open in an unimpeded manner. With the proper flow of gas through the regulator in the direction of arrow A the flap 25 prevents gas from flowing through the seat 20 but will force the valve 26 to open against force of a spring 28 to maintain upstream pressure higher than downstream pressure by an amount governed by the spring 28.
  • the flexible elastomeric flap 25 has a central perforation so that the disc 25 may be held in position by means of a dumbbell shaped portion 24 of the spindle 26.
  • the disc 25 is located at the upstream end of the said spindle. Normally the flexible elastomeric disc 25 is maintained in a closed position, closing off the spindle orifice 22. Should gas flow occur in the opposite direction (under conditions of improper connection or use) to arrow A gas can freely pass through orifice 22.
  • the spring 28 is kept under compression by being positioned between the said spindle seat 20 and flange 33 of a central and axially arranged threaded tube 30.
  • the threaded tube 30 comprises a smooth cylindrical portion 34 over which the spring slides for the purpose of maintaining the spring in a concentric position with the central channel 35, and a threaded portion 31 , screwed into a perforated support structure 40 so that the axial position of threaded tube 30 may be adjusted for the purpose of altering spring force appropriately, the position of the threaded tube 30 being adjustable by means of screw driver placed into the slot 32 of the tube 30.
  • the regulator can take an L-shaped form with downstream channel set at an angle to both the upstream channel and the valve seat so that tube 30 can be extended through the side of the regulator and equipped with a knob to enable the spring force to be varied while the regulator is in use.
  • the fixed support structure 40 placed in the downstream channel 14 comprises a central female threaded orifice 42 for the purpose of holding the threaded tube 30 in position and at least one peripherally arranged orifice 41 to allow the free flow of gas in either direction.
  • the regulator 9 is connected to the outlet 16 of the anaesthetic gas supply machine 10 and the regulator 9 is attached to the inlet of the breathing system 24, 26 which is in turn attached to an endotracheal tube 30 and with a means for ventilating, such as a mechanical ventilator 5 , for the purpose of achieving positive pressure ventilation.
  • the upstream channel 13 of the regulator 9 is also connected by means of port 18 and tube attachment site 19 to the pilot tube 3 and so to the inside of the cuff 2.
  • a rise in airway pressure when positive pressure is generated by the ventilator during the inspiratory phase of controlled ventilation, results in an equal rise of pressures within the regulator 9.
  • the pressure differential across the regulator remains unchanged and therefore any rise in downstream pressure is transmitted to the upstream section which in turn is transmitted by means of the appropriate flow of gas from upstream channel 13, side port 18, pilot tube 3 and so into the endotracheal tube cuff 32.
  • the cuff pressure therefore is continuously maintained above airway pressure by the regulator 10.
  • a fall in airway pressure such as occurs during the passive expiratory phase results in a concomitant fall in pressure in the regulator 9 which in turn allows for gases which accumulated in the cuff during the inspiratory phase to flow outwards, through pilot tube 3, side port 18 and into upstream channel 13. That is to say depressurisation of the cuff occurs to a pressure above airway pressure equal to the opening pressure set across the valve of the regulator 10.
  • the quantity of gas in the endotracheal tube cuff 2 is continuously changing to allow for the equalisation of pressures within the system apart from the specific pressure difference set across the regulator 9.
  • FIGS 3A and 3B variously show regulator 42 with a body 42A of cylindrical form incorporating a stepped bore B which is largest at inlet end I with inlet channel 44 to outlet end O with outlet channel 46. Gas flow through the regulator 42 is normally in the direction of arrow A.
  • the support disc 66 contains a central bore 64 and a large number of bores , typically bore 68.
  • the mounting disc 70 contains an outer ring of apertures 76 and an inner ring 74. Both rings of apertures are separated by radial arms , typically arm 80 extending from a central mounting support ring 78 pierced by bore 72.
  • mounting disc 70 On its downstream side mounting disc 70 has mounted a flexible disc 86 shown in Figure 7.
  • the disc 86 is mounted on spindle 60 by way of a central aperture 88.
  • the mounting disc 70 has mounted on its upstream side a flexible disc 98 shown in Figure 8.
  • Disc 98 is pierced by apertures 74.1 corresponding in shape and axial location to the inner ring of apertures 74 on disc 70.
  • Radial arms 80.1 likewise corresponds to arm 80 on mounting disc 70.
  • Central annulus 78.1 aligns with support ring 78 of disc 70.
  • the annulus 78 has bore 96 by means of which spindle 60 extends through disc 98.
  • Spindle 60 ( Figure 4) is supported at the axial centre of bore B by way of central bores 64, 72 in, respectively, support disc 66 and mounting disc 70.
  • the spindle 60 has an integral boss 62.
  • the boss 62 serves as an end stop for flexible disc 86.
  • a spring washer 90 is locked on to the right hand end of the spindle to serve as an end stop for the left hand end of spring 92 whose right hand end presses against disc 98 by way of a plastic collar 94.
  • the support disc 70 and the flexible disc 98 are mounted so that the arrays of apertures 74 and arms 80 of disc 70 are aligned with apertures 74.1 and arms 80.1 of disc 98 to provide for the least restriction to flow of gases through the apertures 74, 74.1 when open.
  • Spring 92 serves to drive spindle 60 to the left causing disc 86 to seat on the downstream side of support disc 70 unless lifted therefrom by gas flow through apertures 74.1 in disc 100 and corresponding apertures 74 in support disc 70. In this event disc 86 is driven off the support disc 70 to allow the passage of gas through to the outlet passage 46 and onto the endotracheal tube 30.
  • Inlet channel 44 has an outlet tapping formed by side port 34 opening into outlet tube 48 by means of which the regulator 42 is coupled to a pilot tube corresponding to pilot tube 36 of Figure 1.
  • the regulator operates in general terms in a similar way to the regulator 9 described in connection with Figure 2.
  • Regulator 42 is connected ( Figure 1) to the outlet 16 of the anaesthetic gas supply machine 10 and the regulator 9 is attached to the inlet of the breathing system 24, 26 which is in turn attached to an endotracheal tube 30 and system 24, 26 which is in turn attached to an endotracheal tube 30 and with a means for ventilating, such as a mechanical ventilator 5, for the purpose of achieving positive pressure ventilation.
  • the upstream channel 44 of the regulator 42 is also connected by means of port 34 and tube 48 to the pilot tube 3 and so to the inside of the cuff 2.
  • a rise in airway pressure when positive pressure is generated by the ventilator during the inspiratory phase of controlled ventilation, results in an corresponding rise of pressure within the regulator 42.
  • the supply gas flows across the regulator valve 70 in the direction of arrow A by way of apertures 74.1 in disc 98 and apertures 74 in disc 70 and displaces the disc 86 against the action of spring 92 resulting in the spindle 60 being drawn to the right allowing the passage of gas through the disc system from inlet channel 44 to outlet channel 46.
  • the pressure differential across the regulator 42 remains unchanged and therefore any rise in downstream pressure is transmitted to the upstream section 46 which in turn is transmitted by means of the appropriate flow of gas from upstream channel 44, side port 34, pilot tube 3 and so into the endotracheal tube cuff 32.
  • the cuff pressure therefore is continuously maintained above airway pressure by the regulator 42.
  • a fall in airway pressure such as occurs during the passive expiratory phase results in a concomitant fall in pressure in the regulator 42 which in turn allows for gases which accumulated in the cuff during the inspiratory phase to flow outwards, through pilot tube 3, side port 34 and into upstream channel 44. That is to say depressurisation of the cuff occurs to a pressure above airway pressure equal to the opening pressure set across the valve disc 70 of the regulator 42.
  • the quantity of gas in the endotracheal tube cuff 2 is continuously changing to allow for the equalisation of pressures within the system apart from the specific pressure difference set across the regulator 9.

Landscapes

  • 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)
  • Safety Valves (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Massaging Devices (AREA)
  • Pipe Accessories (AREA)

Abstract

Dispositif régulateur de pression à raccorder entre un respirateur de patient et un tube endotrachéal à sonde à ballonnet, comportant un corps doté d'une admission (44) et d'une sortie (46) permettant le passage de gaz respiratoires à envoyer au patient, ainsi qu'une sortie latérale supplémentaire (48) à raccorder au moyen d'un tubage approprié à la sonde à ballonnet, afin d'adapter la pression de cette dernière à la pression respiratoire. Il se compose d'un corps (42A) contenant une valve à ressort (86) pourvue de deux disques oscillants (86, 98) se déplaçant aux côtés opposés d'une plaque perforée (70) perpendiculaire à l'écoulement de gaz.
PCT/GB1991/001450 1990-08-28 1991-08-28 Dispositif de regulation de pression utilise en incubation endotracheale par sonde a ballonnet WO1992003176A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU84494/91A AU659802B2 (en) 1990-08-28 1991-08-28 Pressure control device for endotracheal tube cuff
JP3514386A JPH06503730A (ja) 1990-08-28 1991-08-28 気管内チューブ・カフ用圧力制御装置

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB9018774.1 1990-08-28
GB9018774A GB2248783A (en) 1990-08-28 1990-08-28 Regulating the cuff pressure of an endotracheal tube
GB919105283A GB9105283D0 (en) 1991-03-13 1991-03-13 Pressure regulator for the cuff of an endotracheal tube
GB9105283.7 1991-03-13

Publications (1)

Publication Number Publication Date
WO1992003176A1 true WO1992003176A1 (fr) 1992-03-05

Family

ID=26297563

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1991/001450 WO1992003176A1 (fr) 1990-08-28 1991-08-28 Dispositif de regulation de pression utilise en incubation endotracheale par sonde a ballonnet

Country Status (5)

Country Link
EP (1) EP0546010A1 (fr)
JP (1) JPH06503730A (fr)
AU (1) AU659802B2 (fr)
CA (1) CA2090223A1 (fr)
WO (1) WO1992003176A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001000267A1 (fr) * 1999-06-24 2001-01-04 Caradyne (R & D) Limited Appareil de regulation de la pression du manchon dans une sonde d'intubation tracheale
EP2563438A4 (fr) * 2010-04-30 2015-07-01 Vito Forte Circuit et procédé de régulation de pression dans un ballonnet endotrachéal
WO2016132093A1 (fr) * 2015-02-17 2016-08-25 Smiths Medical International Limited Valves et tubes comprenant des valves

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4471775A (en) * 1982-09-07 1984-09-18 Clair Michael W Endotracheal tube cuff synchronizing system
DE3433785A1 (de) * 1984-09-14 1986-03-27 Manfred Dr.med. 2437 Schönwalde Dahmen Medizinisches instrument zur dauerbeatmung
DE3435900A1 (de) * 1984-09-29 1986-04-10 Siemens AG, 1000 Berlin und 8000 München Einrichtung zum intermittierenden aufblasen eines cuffs fuer ein patienten-beatmungsgeraet

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4471775A (en) * 1982-09-07 1984-09-18 Clair Michael W Endotracheal tube cuff synchronizing system
DE3433785A1 (de) * 1984-09-14 1986-03-27 Manfred Dr.med. 2437 Schönwalde Dahmen Medizinisches instrument zur dauerbeatmung
DE3435900A1 (de) * 1984-09-29 1986-04-10 Siemens AG, 1000 Berlin und 8000 München Einrichtung zum intermittierenden aufblasen eines cuffs fuer ein patienten-beatmungsgeraet

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001000267A1 (fr) * 1999-06-24 2001-01-04 Caradyne (R & D) Limited Appareil de regulation de la pression du manchon dans une sonde d'intubation tracheale
US6647984B1 (en) 1999-06-24 2003-11-18 Caradyne (R&D) Limited Apparatus for controlling cuff pressure in an endotracheal tube
EP2563438A4 (fr) * 2010-04-30 2015-07-01 Vito Forte Circuit et procédé de régulation de pression dans un ballonnet endotrachéal
WO2016132093A1 (fr) * 2015-02-17 2016-08-25 Smiths Medical International Limited Valves et tubes comprenant des valves

Also Published As

Publication number Publication date
AU8449491A (en) 1992-03-17
AU659802B2 (en) 1995-06-01
EP0546010A1 (fr) 1993-06-16
CA2090223A1 (fr) 1992-03-01
JPH06503730A (ja) 1994-04-28

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