WO2003013636A2 - Procede et dispositif de regulation de la pression - Google Patents

Procede et dispositif de regulation de la pression Download PDF

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Publication number
WO2003013636A2
WO2003013636A2 PCT/EP2002/009028 EP0209028W WO03013636A2 WO 2003013636 A2 WO2003013636 A2 WO 2003013636A2 EP 0209028 W EP0209028 W EP 0209028W WO 03013636 A2 WO03013636 A2 WO 03013636A2
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
pressure
control unit
shut
controls
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2002/009028
Other languages
German (de)
English (en)
Other versions
WO2003013636A3 (fr
Inventor
Uwe Becker
Rudolf Hipp
Georg Lohmeier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Muefa AG
Original Assignee
Muefa AG
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 Muefa AG filed Critical Muefa AG
Publication of WO2003013636A2 publication Critical patent/WO2003013636A2/fr
Publication of WO2003013636A3 publication Critical patent/WO2003013636A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61M16/045—Cuffs with cuffs partially or completely inflated by the respiratory gas
    • A61M16/0452—Cuffs with cuffs partially or completely inflated by the respiratory gas following the inspiration and expiration pressure
    • 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
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter

Definitions

  • the present invention relates to a ner driving for regulating a pressure, in particular a cuff pressure, according to the preamble of claim 1 and a device for carrying out the method.
  • Cuffs are preferably used in hospitals and are used there for the use of endotracheal tubes.
  • a cuff is comparable to an inflatable cushion or cuff and is used to seal a tube against a patient's trachea so that the air of a ventilator only enters the lungs through the tube and only escapes from the patient's lungs in this way can.
  • a medium usually air, is applied to the cuff so that it inflates.
  • a ring-shaped cuff can thus seal a tube, which is mounted centrally in this, against the patient's trachea by the inflation of the outer walls of the cuff pressing against the inner walls of the trachea.
  • the medium or air is fed to the cuff through a small feed line and applied either by a syringe, a bellows or a similar suitable device.
  • the functionality of the cuff or its sufficient inflation can be checked using various ner methods known from the prior art.
  • a cuff pressure control is known from US Pat. No. 5,487,383 or US Pat. No. 5,235,973, in which the cuff pressure oscillates between two preset values depending on the expiration or inspiration phase.
  • US 4,825,862 offers a mechanical cuff pressure control in which only the mechanically transmitted breathing pressure is used to control the cuff pressure.
  • the object is achieved by a method according to claim 1 and an apparatus according to claim 10.
  • the invention is based on the knowledge that it is advantageous to include, in addition to the information about the cuff pressure itself, other signals for regulating a cuff pressure, which signals enable an optimal adaptation of the cuff pressure to the current needs.
  • the cuff pressure control can be particularly suitable if, for example, the airway pressure in the endotracheal tube is also taken into account for the cuff pressure control. Since this pressure in the endotracheal tube corresponds to the patient's lung pressure and determines the required sealing effect of the cuff, the cuff pressure to be regulated can be regulated depending on this endotracheal tube pressure. With this type of regulation, there is advantageously the possibility of always keeping the cuff pressure at the minimum pressure level required in each case, and thus avoiding damage to the trachea as best as possible.
  • Pressure peak pressure, plateau pressure, PEEP pressure
  • pressure change flow, increase in flow
  • volume train volume, minute volume
  • lung mechanics resistance, compliance
  • oxygen concentration of the breathing gas CO 2 concentration of the breathing gas
  • respiratory rate I: E- Ratio, spirometry (P / N curve, F / N curve, V / CO 2 curve), SpO 2 (blood oxygen saturation) pO 2 , pCO 2 (partial pressures of O 2 and CO 2 in the blood), temperature ( at different parts of the body), invasively measured blood pressure (arterial pressure, central venous pressure etc.), ECG (heart rate, time of the R wave, pulse height, arrhythmias, values obtained from the heart rhythm or its changes [eg variability of the RR distance], amplitude variability ).
  • any type of data or signals can be used to optimize the cuff pressure control, including those that are hardly or not at all determined, measured or specified for the patient.
  • a signal can also be a start signal (trigger) with which a cuff pressure control controlled by the control unit is triggered in order, for example, to set a suitable pressure curve or to terminate such a setting from the receipt of such a signal.
  • a signal can also be the first or higher change in a physiological or other parameter, so that largely any time profiles of parameters can be used for the cuff pressure control.
  • the method according to the invention uses a shut-off device which, on the one hand, can take over the function of an inflow valve through which a medium (usually air) which is available can be introduced into the cuff.
  • the shut-off device can also or alternatively take on the function of a discharge valve through which the medium can be released from the cuff.
  • the shut-off device can be constructed, for example, in the sense of a 3/2-way valve or another compact valve technology. Of course, independent or largely separately provided valves can also be used for regulating the inflow or outflow processes.
  • the pressure inside the cuff is detected by an appropriate sensor and transmitted to a suitable control unit.
  • This control unit controls the inflow or outflow valve so that a desired pressure is built up in the cuff. This is usually done by first opening the inflow valve with the outflow valve closed, so that the medium present upstream of the inflow valve can get into the cuff.
  • the sensor for determining the cuff pressure reports the resulting pressure to the control unit which, when the desired pressure is reached, controls the inflow valve in such a way that it interrupts the media supply and the medium remains enclosed in the cuff.
  • the cuff pressure is reduced in an analogous manner in that the discharge valve is controlled by the control unit in such a way that it at least partially releases the medium from the cuff.
  • the pressure in the cuff drops, which is detected by the pressure sensor and in turn transmitted to the control unit.
  • control unit not only receives the cuff pressure from the corresponding sensor, but also has access to further data, it can control the cuff pressure, taking into account this additional data.
  • the cuff pressure can thus advantageously also be made variable within a patient's breathing cycle.
  • the inspiration phase there is a higher pressure in the tube and thus also in the lungs in order to fill the ventilated patient's lungs or lungs with breathing gas.
  • a correspondingly higher cuff pressure is required here in order to be able to seal the endotracheal tube against the trachea.
  • the lung pressure is lower in the expiration phase, so that the cuff pressure at a lower level can also fully effect the sealing function.
  • the cuff pressure setting with the present invention can now advantageously take place in direct dependence on the lung pressure of the patient.
  • the procedure thus the optimal cuff pressures (for example resulting from the pressure in the endotracheal tube) can be advantageously fluidly adapted to the requirements.
  • the method ensures that the cuff does not fall below a predefined minimum pressure or determined by the control unit.
  • This function can be used to maintain a minimum safety standard, for example, to ensure that the patient is successfully ventilated.
  • the method ensures compliance with a maximum cuff pressure. This has the advantage that damage to the trachea due to excessive cuff pressure is definitely ruled out.
  • This maximum value can also be determined or calculated by the control unit itself or can be set or predefined by a third party, for example by manual input into a suitable device or via a suitable data interface.
  • a further embodiment of the invention offers the possibility of controlling the valves for the application of the cuff in such a way that the cuff pressure is essentially tracked by a breathing curve of the patient to be ventilated.
  • the pressure profile in the endotracheal tube during a breathing cycle of the patient can serve as a specification for setting the cuff pressure. This advantageously aligns the cuff pressure directly with the patient's lung pressure, so that the minimally required cuff pressure is always present without damaging the trachea by an unnecessarily high cuff pressure.
  • the thus not constant pressure curve in the cuff can also be set with an offset value relative to the pressure in the endotracheal tube.
  • the cuff pressure follows the patient's lung pressure at a different pressure level, the distance of which from the lung pressure is determined by this offset value.
  • the cuff pressure is also tracked to the lung or endotracheal tube pressure, the distance to the lung pressure curve (offset) not having to be kept constant here.
  • the cuff pressure can thus advantageously be tracked to the lung pressure, with cuff pressure conditions to be taken into account separately for each section of the breathing cycle.
  • the difference from cuff pressure to lung pressure during the inspiration phase can be different from the same difference during the expiration phase.
  • An advantageous embodiment of the invention also offers the possibility of subjecting the values transmitted to the control unit to the control unit to a plausibility check. This ensures, for example, that values above the current lung pressure, ventilation cycle time, maximum cuff pressure etc. remain within reasonable limits or have no influence on the control outside of them. In this context, it is also conceivable to generate a corresponding alarm message when determining implausible values.
  • an embodiment of the invention can monitor the operational readiness of the media supply to determine whether the medium with which the cuff is to be acted upon by the inflow valve is actually available upstream of this valve as desired. In conjunction with an alarm message that can also be generated from this, it is thus ensured that the medium can be supplied.
  • connection advantageously also offers the function of monitoring the energy supply of the components involved in the method or reporting their failure by means of a suitable signal.
  • control unit is designed such that it can emit signals, for example status messages about the connected cuff, in such a way that these signals can be processed by a separate unit or by the operator.
  • Information about whether a cuff is connected over the top or whether or to what extent pressure peaks have been detected can thus be transmitted to a ventilator, for example.
  • Further status messages, information about set, changeable or fixed operating parameters, limit values or their exceeding etc. can thus be provided for further processing or for information.
  • the data provided in addition to the cuff pressure of the control unit are supplied by a respirator.
  • data on the pressure in the endotracheal tube which can advantageously be used to regulate the cuff pressure, are usually available in a ventilator and can then be used from there.
  • the device for carrying out the method is integrated in a respirator.
  • the additional information provided by the ventilator which is used in addition to the cuff pressure by the method according to the invention, can be placed and tapped within the same structural unit.
  • the integration of the device according to the invention in a ventilator results in a reduction in separate components which are directly or indirectly related to the ventilation of patients.
  • a respirator which includes the device for carrying out the method according to the invention, thus also offers the cuff pressure control, which would otherwise be provided separately, so that this additional device can be omitted here.
  • setting values, which are used specifically for cuff pressure control can advantageously be entered or adapted via the shared operating panel of the ventilator.
  • the media feed to the cuff is also reasonably parallel to the components used by the ventilator in the direction of the patient, so that here too a standardization of the cuff pressure control device and the ventilator serves to simplify and also save costs. Further advantages of the invention emerge from the subclaims.
  • a control unit 1 is provided.
  • the control unit 1 controls an inflow valve 2 and an outflow valve 3.
  • a medium under suitable pressure is available upstream of the inflow valve 2 in order to flow through the inflow valve 2 when it opens.
  • the medium can escape downstream of the outflow valve 3 when the outflow valve 3 is open.
  • the inflow valve 2 is connected with a downstream outlet to a connection point 4 such that the medium coming from the inflow valve 2 is present in the connection point 4 or can be forwarded from there to a cuff 5.
  • the connection point 4 is connected to an upstream inlet of the outflow valve 3 such that the medium coming from the connection point 4 is present at the outflow valve 3.
  • connection point 4 is connected to a cuff 5 via a connecting line 5a.
  • a cuff 5 is shown schematically in an application.
  • the cuff 5 encloses an endotracheal tube 5b in the form of an annular cushion and simultaneously seals against a trachea 5c of a patient.
  • the cuff 5 Via the connecting line 5a, the cuff 5 is supplied with medium 10, which is fed or discharged via the connection point 4.
  • the connecting line 5a can be detachably connected to the connection point 4.
  • a pressure sensor 4a is provided in the connecting part 4, which detects the pressure in the connecting line 5a or in the cuff 5.
  • a pressure sensor 4a reports the pressure to the control unit 1.
  • the control unit 1 is connected to signal interfaces 6.
  • the signal interfaces 6 supply the control unit 1 with data and / or signals which are processed in the control unit 1.
  • One of these signals can in particular also affect the pressure in the endotracheal tube or in the patient's lungs.
  • limit values, respiratory frequencies or other patient- or treatment-specific parameters can also be transmitted to the control unit.
  • the control unit 1 is provided in such a way that it in turn can also transmit signals and / or data to the signal interfaces. These signals or data can include alarm messages, confirmation or query signals, log data and the like.
  • the method for regulating the cuff pressure proceeds as follows:
  • control unit 1 receives information that is included in the determination of the cuff pressure p c (target pressure) to be set or that specifies it directly.
  • the cuff pressure sensor 4a determines the actual cuff pressure p c and reports this to the control unit 1. 3a. If the target pressure is below the current cuff pressure p c , the control unit 1 controls the inflow valve 2 so that it closes or remains closed, so that no additional medium can get into the cuff. Furthermore, the control unit 1 controls the outflow valve 3 such that it opens or remains open, so that medium can flow out of the cuff. The pressure in the cuff drops.
  • control unit 1 controls the outflow valve 3 so that it closes or remains closed, so that no medium can flow out of the cuff. Furthermore, the control unit 1 controls the inflow valve 2 so that it opens or remains open, so that additional medium can get into the cuff. The pressure in the cuff rises.
  • the cuff pressure sensor 4a also determines the cuff pressure p c and reports this to the control unit 1.
  • the control unit 1 compares the cuff pressure p c detected by the cuff pressure sensor 4a with the predetermined target pressure and follows steps 3a or 3b until the cuff pressure p c approaches the target pressure within a suitable tolerance.
  • the control unit 1 closes the valves 2 and 3 or keeps them closed until the target value deviates from the current cuff pressure p c again to such an extent that regulation according to step 3a or 3b is necessary.
  • the control unit 1 thus permanently determines the current cuff pressure p c via the cuff pressure sensor 4a and continuously adjusts it to the currently required setpoint, which is transmitted to the control unit 1 via the signal interfaces 6 or is determined by the control unit 1 using the signals from the signal interfaces 6 ,
  • the valves can also be actuated in the sense of softer control transitions in such a way that both valves 2 and 3 are fully or partially open for suitable periods of time.
  • the set pressure to be set can in particular be derived from the current pressure in the endotracheal tube p e .
  • the pressure p e which fluctuates more or less periodically during a patient's breathing cycle, is then used by the control unit 1 to regulate the cuff pressure p c to be set in each case.
  • the cuff pressure p c can thus be adapted in a particularly advantageous manner to the currently required minimum pressure, so that it does not have to be kept at a constant level during a patient's breathing cycle.
  • the cuff pressure is then based on the patient's breathing curve and can be derived from the patient's breathing curve or from the pressure in the endotracheal tube p e by means of an offset value, which in turn can be constant or variable.
  • the control unit 1 can output signals to the signal interfaces 6.

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

L'invention concerne un procédé de régulation de la pression, notamment de la pression de ballonnet dans des tubes endotrachéaux, ainsi qu'un dispositif destiné à la mise en oeuvre dudit procédé. L'invention vise à réguler de façon très délicate la pression de ballonnet pour l'étanchéification d'un tube endotrachéal par rapport à la trachée d'un patient devant être assisté en respiration, de manière à soumettre la trachée uniquement à une contrainte minimale nécessaire sans compromettre la respiration artificielle. En plus de la pression de ballonnet, au moins une autre grandeur peut être régulée et transmise à l'unité de commande pour la régulation de ladite pression. Ainsi, il est possible de compenser ou d'adapter la pression de ballonnet aux exigences variables lors du cycle de respiration artificielle.
PCT/EP2002/009028 2001-08-10 2002-08-12 Procede et dispositif de regulation de la pression Ceased WO2003013636A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10139711.9 2001-08-10
DE10139711A DE10139711A1 (de) 2001-08-13 2001-08-13 Druckregelverfahren und Druckregelvorrichtung

Publications (2)

Publication Number Publication Date
WO2003013636A2 true WO2003013636A2 (fr) 2003-02-20
WO2003013636A3 WO2003013636A3 (fr) 2003-10-16

Family

ID=7695293

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2002/009028 Ceased WO2003013636A2 (fr) 2001-08-10 2002-08-12 Procede et dispositif de regulation de la pression

Country Status (2)

Country Link
DE (1) DE10139711A1 (fr)
WO (1) WO2003013636A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102614568A (zh) * 2012-03-28 2012-08-01 单荣芳 人工气道套囊压力无线动态监测装置
RU2733970C1 (ru) * 2019-06-17 2020-10-08 Александр Сергеевич Поляев Система комплексной профилактики осложнений искусственной вентиляции легких

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007062861A1 (de) * 2007-12-21 2009-06-25 Ulrich Frick Befülladapter zum Befüllen eines Cuffs
CN121177628A (zh) * 2025-09-19 2025-12-23 中国人民解放军海军军医大学第二附属医院 一种气管插管套囊压力的智能调控方法及系统

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62186872A (ja) * 1986-02-14 1987-08-15 鳥取大学長 呼吸圧重畳式カフ圧調整装置
US5235973A (en) * 1991-05-15 1993-08-17 Gary Levinson Tracheal tube cuff inflation control and monitoring system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102614568A (zh) * 2012-03-28 2012-08-01 单荣芳 人工气道套囊压力无线动态监测装置
RU2733970C1 (ru) * 2019-06-17 2020-10-08 Александр Сергеевич Поляев Система комплексной профилактики осложнений искусственной вентиляции легких

Also Published As

Publication number Publication date
WO2003013636A3 (fr) 2003-10-16
DE10139711A1 (de) 2003-03-06

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