EP3755408A1 - Stabilisateur de pression pour un manchon pneumatique de cathéter - Google Patents

Stabilisateur de pression pour un manchon pneumatique de cathéter

Info

Publication number
EP3755408A1
EP3755408A1 EP19758270.3A EP19758270A EP3755408A1 EP 3755408 A1 EP3755408 A1 EP 3755408A1 EP 19758270 A EP19758270 A EP 19758270A EP 3755408 A1 EP3755408 A1 EP 3755408A1
Authority
EP
European Patent Office
Prior art keywords
pressure
balloon
inflatable portion
volume
inflatable
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.)
Withdrawn
Application number
EP19758270.3A
Other languages
German (de)
English (en)
Other versions
EP3755408A4 (fr
Inventor
Yair Ramot
Eizik Amar
Oron Zachar
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.)
Airway Medix Sp zoo
Original Assignee
Airway Medix Sp zoo
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 US16/160,668 external-priority patent/US10286170B1/en
Application filed by Airway Medix Sp zoo filed Critical Airway Medix Sp zoo
Publication of EP3755408A1 publication Critical patent/EP3755408A1/fr
Publication of EP3755408A4 publication Critical patent/EP3755408A4/fr
Withdrawn legal-status Critical Current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. mouth-to-mouth respiration; 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • 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
    • A61M16/01—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes specially adapted for anaesthetising
    • 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
    • A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
    • 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
    • A61M16/06—Respiratory or anaesthetic masks
    • 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • 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
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0266—Nitrogen (N)
    • A61M2202/0283—Nitrous oxide (N2O)
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3341—Pressure; Flow stabilising pressure or flow to avoid excessive variation
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1028—Larynx
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1032—Trachea

Definitions

  • the inflatable portion of the balloon contains a second-medium-pressure volume of air, (a) the inflatable portion of the balloon has a second-medium pressure of 30 cm H20, and (b) at least 20% of the outer surface of the inflatable portion of the balloon touches a portion of the inner surface of the protective housing; the second-medium-pressure volume of air equals the sum of (a) the base low-pressure volume of air and (b) a second incremental quantity of air that is between 10 cc and 50 cc.
  • a pressure display which is configured to display the pressure sensed by the pressure sensor
  • Inventive concept 120 The cuff pressure stabilizer according to Inventive concept 119, wherein the first and the second inflatable portions include a same material, and wherein the first and the second inflatable portions have first and second average wall thicknesses, respectively, that equal each other.
  • an average rate of change of the aggregate pressure-volume curve over a first pressure interval between 25 and 30 cm H20 is between 0.3 and 2 cm H20 / cc.
  • the cuff pressure stabilizer is characterized by an aggregate pressure-volume curve that represents the pressure in the first and the second inflatable portions when inflated, in aggregate, with different aggregate incremental volumes of air beyond the base low- pressure volume of air,
  • each of the first and the second inflatable portions contains, in aggregate, a base aggregate low-pressure volume of air, each of the first and the second inflatable portions has a base low pressure of 10 cm H20,
  • Inventive concept 131 A system including the cuff pressure stabilizer according to any one of Inventive concepts 29-55, wherein the system further includes the airway ventilation device.
  • a cuff pressure stabilizer for use (a) in contact with the atmosphere and (b) with an airway ventilation device having an inflatable cuff, an inflation lumen, and an inflation lumen proximal port, the cuff pressure stabilizer including:
  • Fig. 8A includes "confined” and “free” pressure-volume curves of a first inflatable portion of a first elastic balloon of the cuff pressure stabilizer of Fig. 5, in accordance with an application of the present invention
  • airway ventilation device 10 is a laryngeal mask airway (LMA) device 24, and inflatable cuff 11 is an inflatable cuff 28 (which is typically annular) that is insertable through a mouth of a patient to an inserted location within the patient, such that an anterior side of the cuff forms a seal around a laryngeal inlet of the patient upon inflation of the cuff.
  • LMA laryngeal mask airway
  • the LMA device is suitable for facilitating lung ventilation.
  • the working medium pressure may be between 15 and 60 cm H20, such as between 20 and 60 cm H20, e.g., between 25 and 55 cm H20, such as between 40 and 50 cm H20.
  • inflatable cuff 28 typically has a volume of between 25 and 50 cc, depending on the size of LMA device 24.
  • First and second frustoconical portions 160A and 160B geometrically define respective cones 170A and 170B (portions of which are labeled in Fig. 3B).
  • cones 170A and 170B intersect each other at one or more angles a (alpha), at least one of which is greater than 45 degrees.
  • at least one of the angles is less than 90 degrees.
  • all of the angles are greater than 45 degrees, and/or all of the angles are less than 90 degrees.
  • a "rising point of inflection” is a point of inflection at which the third derivative is positive, i.e., the curve is upward- flowing about the point and the curve changes from concave to convex from lower to higher pressures across the inflection point.
  • concave means concave downward
  • convex means concave upward, in accordance with the common definitions in calculus.
  • the one or more internal protective surfaces 354 and 355 are shaped and first and second inflatable portions 350 and 351 are configured such that the first volume equals at least 50% of the second volume when each of first and second inflatable portions 350 and 351 is inflated at the first-medium pressure of 15 cm H20, such as, for example, could be the pressure illustrated in Fig. 7B.
  • second inflatable portion 351 of second elastic balloon 349 of cuff pressure stabilizer 300 would be characterized by "free" pressure-volume curve 412 if second inflatable portion 351 were not disposed within second portion 357 or otherwise confined, i.e., unlike the configuration of cuff pressure stabilizer 300 described herein with reference to Figs. 5-7C, but like the configuration of cuff pressure stabilizer 600, described hereinbelow with reference to Fig. 11.
  • "free" pressure-volume curve 412 reflects physical, structural properties of second inflatable portion 351.
  • Figs. 12A-C are schematic cross-sectional illustrations of a cuff pressure stabilizer 800 with an elastic balloon 848 thereof inflated at different pressures, in accordance with an application of the present invention.
  • cuff pressure stabilizer 800 is similar cuff pressure stabilizer 300 described hereinabove with reference to Figs. 5-9, may implement any of the features thereof, and is for use with airway ventilation device 10 (e.g., tracheal ventilation tube 22 or laryngeal mask airway (LMA) device 24).
  • airway ventilation device 10 e.g., tracheal ventilation tube 22 or laryngeal mask airway (LMA) device 24.
  • LMA laryngeal mask airway
  • cuff pressure stabilizer 100 further comprises an inflation valve 191, which may, for example, comprise an on/off "push-valve” (e.g., conventional ETT inlet valve), or a one-way valve, or another kind of valve.
  • Cuff pressure stabilizer 100 further comprises a switchable pre-inflate valve 193, disposed along a fluid-communication path between stabilizer port 122 and inflation lumen proximal port connector 124, such as along connector tube 125, described hereinabove with reference to Figs. 1A-C.
  • inflation lumen proximal port connector 124 that is shaped to form an air-tight seal with inflation lumen proximal port 15 of airway ventilation device 10.
  • Switchable pre-inflate valve 193 is configured to be switchable between a close configuration, in which the valve blocks fluid flow therethrough, and an open configuration, in which the valve allows fluid flow therethrough.
  • cuff pressure stabilizer 100 further comprises a flow limiter 194, which is configured to slow the pressure-regulation response time of cuff pressure stabilizer 100.
  • This flow regulation prevents the cuff pressure stabilizer from responding erratically to changes of pressure in inflatable cuff 11 of airway ventilation device within a single ventilation cycle, but rather to regulate only pressure changes that continue over an extended period of time.
  • the above- mentioned second-medium incremental quantity Q2 of air may be at least 10 cc (e.g., at least 20 cc), no more than 50 cc (e.g., no more than 40 cc), and/or between 10 and 50 cc, such as between 20 and 40 cc.
  • inner surface 954 of protective housing 910 is shaped so as to include one or more cylindrical portions 960.
  • Balloon 948 is arranged such that inflatable portion 950 of balloon 948 is disposed inside protective housing 910, typically such that:
  • the at least a portion of the one or more cylindrical portions 960 touched by inflatable portion 950 has a length of at least 0.5 cm, such as at least 1 cm, measured along a central longitudinal axis of the one or more cylindrical portions 960.
  • Protective housing 910 is configured such that inflation of inflatable portion 950 of balloon 948 to beyond the threshold volume causes:
  • moveable portion 962 of protective housing 910 includes an accordion-pleated surface that allows for moving of moveable portion with respect to base portion 964 and expansion of the internal volume of protective housing 910 without necessarily increasing the inner surface area of protective housing 910 (configuration not shown).

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)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

La présente invention concerne un stabilisateur de pression pour manchon (100, 900) qui comprend un boîtier de protection (110, 910) et un ballonnet (148, 948) disposé à l'intérieur de celui-ci. Le ballonnet (148, 948) a une basse pression de base de 10 cm H20 lorsqu'il contient un volume d'air basse pression de base. Lorsque le ballonnet (148, 948) contient un premier volume d'air à pression moyenne, le ballonnet (148, 948) a une première pression moyenne de 15 cm H20, et inférieure à 15 % d'une surface externe (152, 952) du ballonnet (148, 948) touche une surface interne (154, 954) du boîtier (110, 910). Lorsque le ballonnet (148, 948) contient un second volume d'air à pression moyenne, le ballonnet (148, 948) a une seconde pression moyenne de 30 cm H20, et au moins 20 % de la surface externe (152, 952) du ballonnet (148, 948) touche une partie de la surface interne (154, 954) du boîtier (110, 910). La présente invention concerne également d'autres modes de réalisation.
EP19758270.3A 2018-02-20 2019-02-14 Stabilisateur de pression pour un manchon pneumatique de cathéter Withdrawn EP3755408A4 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862632668P 2018-02-20 2018-02-20
US16/160,668 US10286170B1 (en) 2018-02-20 2018-10-15 Catheter inflatable cuff pressure stabilizer
US201862758007P 2018-11-09 2018-11-09
US201862774588P 2018-12-03 2018-12-03
PCT/IL2019/050176 WO2019162939A1 (fr) 2018-02-20 2019-02-14 Stabilisateur de pression pour un manchon pneumatique de cathéter

Publications (2)

Publication Number Publication Date
EP3755408A1 true EP3755408A1 (fr) 2020-12-30
EP3755408A4 EP3755408A4 (fr) 2022-01-12

Family

ID=67688016

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19758270.3A Withdrawn EP3755408A4 (fr) 2018-02-20 2019-02-14 Stabilisateur de pression pour un manchon pneumatique de cathéter

Country Status (3)

Country Link
EP (1) EP3755408A4 (fr)
JP (1) JP2021514284A (fr)
WO (1) WO2019162939A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112156306B (zh) * 2020-09-10 2023-03-21 西安交通大学 一种实时监测套囊压力的气管插管

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4119101A (en) * 1976-03-01 1978-10-10 Victor Igich Multiple lumen endotracheal tube and cuff with limited inflation and pressure
US4134407A (en) * 1977-03-25 1979-01-16 Elam James O External pressure-volume monitor for endotracheal cuff
US4552558A (en) * 1983-07-14 1985-11-12 Rudolph Muto Pressure warning, indicating and applying monitor for cuff type indwelling devices
DK163282C (da) * 1990-01-15 1992-08-03 Vagn Niels Finsen Lomholt Luftreservoir til regulering af trykket i et respirationskateters taetningsblaere
DE102012112097A1 (de) * 2012-12-11 2014-06-12 TRACOE medical Frankfurt Druckausgleichsvorrichtung

Also Published As

Publication number Publication date
JP2021514284A (ja) 2021-06-10
EP3755408A4 (fr) 2022-01-12
WO2019162939A1 (fr) 2019-08-29

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