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WO2009035366A1 - Dispositif de régulation et de commande de pression dans une manchette de conduite d'air - Google Patents

Dispositif de régulation et de commande de pression dans une manchette de conduite d'air Download PDF

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Publication number
WO2009035366A1
WO2009035366A1 PCT/RU2007/000726 RU2007000726W WO2009035366A1 WO 2009035366 A1 WO2009035366 A1 WO 2009035366A1 RU 2007000726 W RU2007000726 W RU 2007000726W WO 2009035366 A1 WO2009035366 A1 WO 2009035366A1
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
pressure
duct
balloon
volume
Prior art date
Application number
PCT/RU2007/000726
Other languages
English (en)
Russian (ru)
Inventor
Mikhail Kozhevnikov
Original Assignee
Mikhail Kozhevnikov
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 Mikhail Kozhevnikov filed Critical Mikhail Kozhevnikov
Publication of WO2009035366A1 publication Critical patent/WO2009035366A1/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

  • the invention relates to medicine, mainly to devices and devices for monitoring and regulating the pressure in the cuff of the duct connected, in particular, with an endotracheal tube or laryngeal mask. Ensuring airway patency, as a rule, is carried out by various ducts (laryngeal masks, endotracheal tubes), including with a swollen cuff. The cuff, inflating, creates the tightness necessary for ventilation and separation of the digestive and respiratory tracts.
  • the pressure exerted by the duct cuff on the mucosa should not exceed 60 cm water column (H 2 O) for the laryngeal mask and 20-30 cm water column (H 2 O) for the endotracheal tube. If the cuff pressure is exceeded, the blood supply to the mucosa is disturbed and pressure sores can occur - foci of necrosis. If the pressure is below optimal, then the cuff will not perform its functions - ensuring the sealing and isolation of the respiratory and digestive tracts. Considering that currently there are already about 200 million cases of using the laryngeal mask, the relevance of solving the problem is understandable.
  • the pressure in the cuff of the duct should not change during the manipulation and be optimal for the duct used.
  • the value of the required optimum pressure in the cuff of the duct is standardly set by the manufacturer of the duct.
  • a number of factors affect the pressure in the cuff of the duct: ⁇ Small changes in pressure in the temperature of the cuff surrounding the duct associated with the air that is introduced into the gas cuff physics is different from the human body temperature and the gas in the cuff, taking the patient’s temperature, varies in volume.
  • Penetration of nitrous oxide into the cuff of the duct is a cuff of the duct that is permeable to nitrous oxide and can increase the gas volume several times the increase in gas volume leads to a significant increase in pressure
  • Muscle contractions of the pharynx Alternating compression also leads to a decrease in volume, muscle relaxation may be to an increase in the volume of the cuff caused by swallowing of the laryngeal mask with movements that can occur with insufficiently deep anesthesia.
  • the pressure in the cuff of the duct at the beginning of anesthesia differs significantly from the pressure in it later. Therefore, a single measurement of pressure during inflation of the cuff of the duct is not enough.
  • the pressure in the cuff of the duct must be in a narrow range between Pl and P2 with a significant change in volume from Vl to V2, i.e. a "pressure" plate should be provided.
  • the anesthesiologist seeks to prevent complications, he is forced to repeatedly visually monitor the pressure in the cuff of the duct during the operation or use a special device to control and optimize the pressure.
  • a can for monitoring and optimizing the pressure in the cuff is described in patent RFZhZ 150300, 2000.06.10, relating to the design and use of the endotracheal tube.
  • the condition of the cuff is checked, and the necessary amount of air is set to inflate it.
  • air is fed into the catheter and the cuff is inflated, focusing on the initially selected volume of air.
  • the cuff is inflated only before it contacts the tracheal wall.
  • the disadvantage of this device is that it does not return it to a structurally specified level when the pressure changes. A visual check by the doctor and manual pressure changes are required.
  • the cuff pressure increases, and when using the inventive device, it remains unchanged or slightly decreases.
  • the disadvantage of this device is also that when it changes the pressure does not return it to a structurally predetermined level. It is necessary to visually check the doctor and manually change the pressure by pressing fingers on the protruding parts of the elastic balloon.
  • the task to which the claimed invention is directed is to create such a device for regulating and controlling the pressure in the cuff of the duct of the laryngeal mask or endotracheal tube, which will allow, being easy to control and manufacture, significantly reduce the level of pathophysiological changes in the body as responses to the introduction of the duct.
  • the device for regulating and controlling the pressure in the cuff of the duct contains an elastic balloon and a housing with holes for supplying air, while the elastic balloon is made of polymer material and is tightly fixed over one of the holes in the housing, at the lower base of the elastic polymer balloon a flexible longitudinal plate is fixed, the free edge of which can be combined with a mark applied to the surface of the cylinder, and the material and wall thickness of the elastic polymer cylinder underneath branes in such a way that they provide constant pressure (maintain a normally stable pressure) in the cuff of the duct when the volume in the system of the cuff of the duct — an elastic balloon, changes.
  • the polymer balloon can be made of any material with high elasticity.
  • the transverse dimensions of the elastic polymer balloon are smaller than the longitudinal ones.
  • nitrous oxide Penetration of nitrous oxide into nitrous oxide enters the cylinder.
  • the cuff can increase the volume Changes in the gas volume even in the gas several times several times does not affect the pressure.
  • the surface area of the cylinder through which nitrous oxide diffuses is greater than the area of the cuff, so nitrous oxide diffuses from the balloon faster than into the cuff, so this factor has no effect on the pressure in the cuff.
  • the diffusion of nitrous oxide from the cylinder into the atmosphere is orders of magnitude lower than the diffusion of nitrous oxide from the apparatus and the respiratory circuit, therefore, this device cannot significantly affect the concentration of nitrous oxide in the operating room.
  • Muscle contractions of the pharynx With a reduction in volume, this leads to a decrease in volume, the cuff air moves to an increase in the volume of the cuff balloon, and when the volume of the cuff increases, the air returns. The pressure does not change. Thus, the cuff pressure is strictly constant (due only to the technical characteristics of the polymer) and does not depend on external influencing factors.
  • the present invention is a device, the creation of which will overcome certain disadvantages identified in the practical application of such devices known from the prior art.
  • a new technical result obtained from the use of the present invention is that it provides constant pressure (maintains a normally stable pressure) in the cuff of the duct when the volume in the duct cuff-cylinder system changes, it is also cheap, easy to install, and therefore it can be apply in all cases where ducts with an inflated cuff are used. Blood supply to the mucous membrane is not disturbed and pressure sores cannot occur - foci of necrosis. This provides its advantages over devices of this type known from the prior art.
  • FIG. 1 shows a General view of the inventive device
  • FIG. 2 - a device in an assembly with an air duct
  • FIG. 3 graphs explaining the operation of the device.
  • a device for regulating and controlling the pressure in the cuff of the duct consists of an elastic polymer cylinder 1, hermetically mounted on a hollow body 2, having a hole for supplying air to the elastic cylinder 1 at the top, the body 2 has an inlet valve 3 and an outlet connector 4.
  • a flexible plate 5 is fixed, which serves to indicate the required volume of filling of the cylinder.
  • On the surface of the cylinder 1 is marked 6, indicating the boundary level of filling of the cylinder 1 with air.
  • the connector 4 is used to connect through valve 7 with a pilot balloon / catheter / 8 for supplying air to the cuff of the duct / not shown /.
  • the device is connected by a connector 4 to the valve 7 of the pilot balloon 8 of the duct, the cuff of which controls the pressure.
  • a syringe is inserted into the inlet of the inlet valve 3. Through the inlet valve 3, air is injected with a syringe through an opening in the housing 2 into an elastic balloon 1. At the time when the mark 6 reaches the upper edge of the flexible plate 5, the air supply to the device is stopped. At the same time, the pressure in the cuff of the duct reaches the norm recommended by the manufacturer of the duct specifically for each manufacturer. The pressure in the cuff is optimally regulated from the pressure necessary for sealing the trachea to the necessary blood flow to restore adequate pressure in its wall. The syringe is disconnected from the inlet valve 3. The device is ready for operation.
  • the pressure adjustment in the cuff of the duct is as follows. As already indicated, during anesthesia, the pressure in the cuff of the duct can vary both in one direction and in the other.
  • the device can be equipped with a very compact, stand-alone electronic signaling device, which can be placed in a hollow housing 2.
  • the pressure in the cuff of the duct was monitored in 5 patients for anesthesia during urological operations. No side effects have been identified.
  • the control measurement of pressure in the cuff of the duct was carried out in beginning and end of the operation using a standard pressure gauge. The pressure in the cuff of the duct did not go beyond the declared 20-30 cm and 50-60 cm water column.
  • the inventive device for regulating and controlling pressure is a simple device for regulating and controlling pressure
  • the device is extremely low cost in mass production. If you complete reusable laryngeal masks with this inventive device, the price change will not be noticeable, but they will have an undeniable competitive advantage - safety in relation to pressure sores. In disposable air ducts, this device can be used to replace a pilot cylinder; this will also not have a significant impact on the cost of the air duct as a whole;
  • the device can “forgive the user's mistakes ⁇ i.e. even if the initial inflation is incorrect (permissible error up to ⁇ 100% of the volume of the cuff of the duct), the device will provide a cuff pressure that is safe for the patient.
  • the device does not contact directly with the skin and mucous membranes of the patient; therefore, it cannot cause allergies. Yu
  • the inventive device has passed laboratory and clinical trials and can be widely used in clinical practice.

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)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

Le dispositif de l'invention comprend une bouteille souple et un boîtier avec des trous d'amenée d'air qui est fixé hermétiquement au-dessus de l'un des orifices du boîtier. Près de la base inférieure de la bouteille on a fixé une plaque longitudinale souple dont le bord libre peut se placer au niveau d'un repère fait à la surface de la bouteille. Le matériau et l'épaisseur des parois de la bouteille souple en polymère sont choisis de manière à assurer une pression stable (on maintient une pression normale stable) dans la manchette d'une conduite d'air en cas de changement du volume dans le système de la manchette de la conduite d'air. La nouveauté qu'apporte l'invention consiste en ce qu'elle permet d'assurer une pression invariable (une pression normale stable) dans la manchette d'une conduite d'air en cas de changement du volume dans le système de la manchette de la conduite d'air. Le dispositif de l'invention est également peu coûteux, facile à monter et peut s'utiliser dans tous les cas lorsque l'on utilise des conduites d'air à manchette gonflable. On évite ainsi la perturbation de l'amenée de sang vers la muqueuse et la formation d'escarres de décubitus, ce qui assure son avantage par rapport aux dispositifs existants de ce type d'équipements.
PCT/RU2007/000726 2007-09-11 2007-12-24 Dispositif de régulation et de commande de pression dans une manchette de conduite d'air WO2009035366A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2007133818/14A RU2387366C2 (ru) 2007-09-11 2007-09-11 Устройство для регулирования и контроля давления в манжете воздуховода
RU2007133818 2007-09-11

Publications (1)

Publication Number Publication Date
WO2009035366A1 true WO2009035366A1 (fr) 2009-03-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2007/000726 WO2009035366A1 (fr) 2007-09-11 2007-12-24 Dispositif de régulation et de commande de pression dans une manchette de conduite d'air

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RU (1) RU2387366C2 (fr)
WO (1) WO2009035366A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013139986A1 (fr) * 2012-03-22 2013-09-26 Universität Zürich Dispositif pour la régulation entraînée par gravité de la pression de remplissage d'un ballonnet de cathéter

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6655390B2 (ja) * 2012-06-12 2020-02-26 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． ユーザにガスを供給する患者インタフェース

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4134407A (en) * 1977-03-25 1979-01-16 Elam James O External pressure-volume monitor for endotracheal cuff
RU2150300C1 (ru) * 1998-08-10 2000-06-10 Первак Владимир Анатольевич Эндотрахеальная трубка
US20030172925A1 (en) * 1997-12-24 2003-09-18 Mario Zocca Monitoring and control for a laryngeal mask airway device
US20070032729A1 (en) * 2003-10-21 2007-02-08 Juergen Fortin Device and method for controlling the pressure in an inflatable cuff of a blood pressure manometer

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1931244A2 (fr) * 2005-09-13 2008-06-18 Welch Allyn, Inc. Ensemble de soupape de purge de la pression sanguine

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4134407A (en) * 1977-03-25 1979-01-16 Elam James O External pressure-volume monitor for endotracheal cuff
US20030172925A1 (en) * 1997-12-24 2003-09-18 Mario Zocca Monitoring and control for a laryngeal mask airway device
RU2150300C1 (ru) * 1998-08-10 2000-06-10 Первак Владимир Анатольевич Эндотрахеальная трубка
US20070032729A1 (en) * 2003-10-21 2007-02-08 Juergen Fortin Device and method for controlling the pressure in an inflatable cuff of a blood pressure manometer

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013139986A1 (fr) * 2012-03-22 2013-09-26 Universität Zürich Dispositif pour la régulation entraînée par gravité de la pression de remplissage d'un ballonnet de cathéter
US9744336B2 (en) 2012-03-22 2017-08-29 University Of Zurich Device for gravity-driven control of the filling pressure of a catheter balloon

Also Published As

Publication number Publication date
RU2387366C2 (ru) 2010-04-27
RU2007133818A (ru) 2009-03-20

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