ES2565219T3 - Adaptador de circuito de ventilación y sistema proximal de administración de aerosol - Google Patents

Adaptador de circuito de ventilación y sistema proximal de administración de aerosol Download PDF

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ES2565219T3
ES2565219T3 ES09722804.3T ES09722804T ES2565219T3 ES 2565219 T3 ES2565219 T3 ES 2565219T3 ES 09722804 T ES09722804 T ES 09722804T ES 2565219 T3 ES2565219 T3 ES 2565219T3
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aerosol
flow channel
adapter
flow
ventilation
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Jan Mazela
Christopher Henderson
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Windtree Therapeutics Inc
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Discovery Laboratories Inc
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    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0003—Details of inhalators; Constructional features thereof with means for dispensing more than one drug
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0833—T- or Y-type connectors, e.g. Y-piece
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/147—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase the respiratory gas not passing through the liquid container
    • 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
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • 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
    • A61M15/00—Inhalators
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/0858—Pressure sampling ports
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1075—Preparation of respiratory gases or vapours by influencing the temperature
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • 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
    • 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
    • A61M2202/0208—Oxygen
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or Bluetooth®
    • 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/18—Coaxial flows, e.g. one flow within another

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Nozzles (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Catching Or Destruction (AREA)

Abstract

Un adaptador (10) para administrar un agente activo en aerosol a un paciente con ventilación por presión positiva concomitante, que comprende: un puerto de interfaz del paciente (16); un canal de flujo del aerosol (12) que tiene un puerto de entrada del aerosol (14) y un puerto de salida del aerosol (30), donde el canal de flujo del aerosol (12) se extiende desde el puerto de entrada del aerosol (14) al puerto de salida del aerosol (30) y donde el canal de flujo del aerosol (12) define un recorrido del flujo del aerosol (21) a lo largo de su extensión; y un canal de flujo del gas de ventilación (19) en comunicación fluida con el puerto de salida del aerosol (30) y que tiene un puerto de entrada del gas de ventilación (20) y un puerto de salida del gas de ventilación (22) y que define un recorrido del flujo del gas de ventilación, y donde el recorrido del flujo del gas de ventilación está al menos parcialmente desviado del recorrido del flujo del aerosol (21) y al menos parcialmente rodea al canal de flujo del aerosol (12) para permitir que el gas de ventilación fluya alrededor del canal de flujo del aerosol (12).

Description

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Ejemplo 2 -Mediciones de resistencia de diferentes diseños de adaptadores
El propósito de este estudio fue evaluar las características operativas de diferentes adaptadores de circuitos de
5 ventilación usados para la introducción de aerosol en el circuito de ventilación CPAP en el nivel de un conector 'Y'. Las características operativas se evaluaron en base a los valores de resistencia de diferentes adaptadores testeados bajo condiciones típicas de ventilación para la población neonatal objetivo potencial.
El protocolo fue diseñado para caracterizar las características operativas de tres adaptadores de circuitos de
10 ventilación diferentes y un conector 'Y' estándar bajo condiciones de flujo dinámico como la ventilación mecánica intermitente (IMV): a) el adaptador según se describe en la publicación de la patente US de Estados Unidos 2006/0120968 de Niven et al. (el adaptador 1); b) un 'adaptador de alta resistencia para CPAP' (el adaptador 2 como se muestra en las Figs. 1A, 2A-4, tubo de flujo del aerosol de 10 mm); c) un 'adaptador de baja resistencia' (el adaptador 3 como se muestra en las Figs. 1A, 2A-4, flujo de flujo del aerosol de 5-6 mm); y d) un 'conector Y
15 estándar' (el adaptador 4). Estos adaptadores para CPAP se testearon bajo dos condiciones de flujo inspiratorio diferentes (aproximadamente 1 y 3 L/min respectivamente). Las características operativas de los diferentes adaptadores se basaron en las mediciones de resistencia realizadas mediante manometría y neumotacografía de las vías respiratorias.
20 El circuito del ventilador se basó en el pequeño ventilador para animales de Harvard. Un extremo del miembro inspiratorio del circuito se conectó al puerto inspiratorio del ventilador y el otro extremo al puerto inspiratorio del adaptador del circuito de ventilación testeado. El miembro espiratorio del circuito se conectó al puerto espiratorio del adaptador y el otro extremo a puerto espiratorio del ventilador de Harvard. Un manómetro de presión se conectó al adaptador mediante el puerto de monitoreo de la presión. El manómetro de presión se calibró antes de la iniciación
25 del experimento. El puerto del aerosol del adaptador se cerró de manera segura.
Hubo 1 registro por cada medición realizada en base a los cálculos del PEDS de al menos 10 ciclos de respiración. Los datos representan los valores de la media y el error estándar de la media (SEM) de la resistencia inspiratoria, espiratoria y total.
30 Los resultados están presentados como valores de la media y SEM para la resistencia total, inspiratoria y espiratoria en la Tabla 2. Ninguno de los adaptadores testeados mostró valores de resistencia superiores (dentro del 10%) en comparación con 'el conector Y estándar' (el adaptador 4), que sirvió como referencia para esta prueba. De hecho, el 'adaptador de alta resistencia' (el adaptador 2) arrojó valores de resistencia menores medidos bajo dos condiciones
35 de flujo inspiratorio diferentes que el 'conector Y estándar'.
TABLA 2
PIF = 1,3-1,4 mL/min
PIF = 2,9-3,2 mL/min
Resistencia mL/cmH20
Resistencia mL/cmH20
Adaptador
Inspiratoria Espiratoria Total Inspiratoria Espiratoria Total
media
SEM media SEM media SEM media SEM media SEM Media SEM
#1
28,02 0,68 35,56 0,12 24,62 0,06 33,58 0,23 57 0,7 39,98 1,46
#2
27,9 0,44 32,08 0,04 25,34 0,07 26 0,22 49,78 0,28 30,43 0,19
#3
33,63 0,28 35,55 0,13 27,11 0,18 31,57 0,18 55,17 0,57 38,74 0,21
#4
32,04 0,28 30,26 5,5 26,61 0,7 29,98 0,4 55,39 0,33 36,46 0,27
Ejemplo 3 -Estudio preclínico
40 Un estudio preclínico en corderos prematuros tuvo como objetivo probar la eficacia de lucinactante para inhalación para la prevención del RDS, y ha utilizado una realización del adaptador del circuito ventilatorio de la invención como se muestra en las Figs. 1A, 2A. Cuatro corderos prematuros con una edad de gestación de 126-128 días fueron tratados con CPAP luego del parto prematuro. El tratamiento con surfactante en aerosol se inició dentro de los 30
45 minutos luego del nacimiento. El adaptador administró de manera eficiente aerosol a los animales sin que se registrara ningún efecto adverso.
Referencias:
50 1. Kattwinkel, J., et al., Technique for intrapartum administration of surfactant without requirement for an endotracheal tube. J Perinatol, 2004. 24: p. 360-365.
2. Trevisanuto, D., et al., Laryngeal mask airway used as a delivery conduit for the administration of surfactant to preterm infants with respiratory distress syndrome. Biol Neonate, 2005. 87(4): p. 217-20.
3. Richardson, C. and A. Jung, Effect of continuous positive airway pressure on pulmonary function and blood 55 gases of infants with respiratory distress syndrome. Pediatr Res, 1978. 12: p. 771-4.
4. Gaon, P., et al., Assessment of effect of nasal continuous positive pressure on laryngeal opening using fibre
16
optic laryngoscopy. Arch Dis Child Fetal Neonatal Ed, 1999.80(3): p. F230-2.
5. Thomson, M., et al., Treatment of immature baboons for 28 days with early nasal continuous positive airway pressure. Am J Respir Crit Care Med, 2004. 169(9): p. 1054-62.
6. Verder, H., et al., Surfactant therapy and nasal continuous positive airway pressure for newborns with 5 respiratory distress syndrome. Danish-Swedish Multicenter Study Group. N Engl J Med, 1994.331(16): p. 1051-5.
7.
Verder, H., et al., Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks’ gestation. Pediatrics, 1999. 103(2): p. E24.
8.
Dolovich, M., Influence of inspiratory flow rate, particle size, and airway caliber on aerosolized drug delivery to the lung. Respir Care, 2000. 45(6): p. 597-608.
10 9. Becquemin, M., et al., Particle deposition and resistance in the nose of adults and children. Eur Respir J, 1991.
4: p. 694-702.
10. Salmon, B., N. Wilson, and M. Silverman, How much aerosol reaches the lungs of wheezy infants and toddlers. Arch Dis Child, 1989.65: p. 401-403.
11. Fink, J.B., et al., Can high efficiency aerosol delivery continue after extubation. Crit Care, 2005. 9(Suppl1): p. 15 P129.
12. Beck, J., et al., Prolonged neural expiratory time induced by mechanical ventilation in infants. Pediatr Res, 2004. 55(5): p. 747-754.
17

Claims (1)

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ES09722804.3T 2008-03-17 2009-03-17 Adaptador de circuito de ventilación y sistema proximal de administración de aerosol Active ES2565219T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US6985008P 2008-03-17 2008-03-17
US69850P 2008-03-17
US7644208P 2008-06-27 2008-06-27
US76442P 2008-06-27
PCT/US2009/037409 WO2009117422A2 (en) 2008-03-17 2009-03-17 Ventilation circuit adaptor and proximal aerosol delivery system

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ES2565219T3 true ES2565219T3 (es) 2016-04-01

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US (3) US9592361B2 (es)
EP (1) EP2265309B1 (es)
JP (1) JP5507539B2 (es)
KR (1) KR101259246B1 (es)
AU (1) AU2009225740B2 (es)
BR (1) BRPI0908556B8 (es)
CA (1) CA2718902C (es)
CY (1) CY1117293T1 (es)
DK (1) DK2265309T3 (es)
ES (1) ES2565219T3 (es)
HR (1) HRP20160258T1 (es)
HU (1) HUE028653T2 (es)
MX (1) MX2010010139A (es)
NZ (1) NZ588478A (es)
PL (1) PL2265309T3 (es)
RS (1) RS54634B1 (es)
RU (1) RU2463084C2 (es)
SI (1) SI2265309T1 (es)
WO (1) WO2009117422A2 (es)
ZA (1) ZA201007239B (es)

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