WO2013033589A1 - Insufflateur-exsufflateur manuel - Google Patents

Insufflateur-exsufflateur manuel Download PDF

Info

Publication number
WO2013033589A1
WO2013033589A1 PCT/US2012/053431 US2012053431W WO2013033589A1 WO 2013033589 A1 WO2013033589 A1 WO 2013033589A1 US 2012053431 W US2012053431 W US 2012053431W WO 2013033589 A1 WO2013033589 A1 WO 2013033589A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
fluid chamber
inexsufflation
hollow body
piston
Prior art date
Application number
PCT/US2012/053431
Other languages
English (en)
Inventor
John Bach
Lou SAPORITO
Patrick FOYE
Original Assignee
University Of Medicine And Dentistry Of New Jersey
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 University Of Medicine And Dentistry Of New Jersey filed Critical University Of Medicine And Dentistry Of New Jersey
Publication of WO2013033589A1 publication Critical patent/WO2013033589A1/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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0072—Tidal volume piston pumps
    • 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
    • A61M16/0009—Accessories therefor, e.g. sensors, vibrators, negative pressure with sub-atmospheric pressure, e.g. during expiration
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/105—Filters
    • A61M16/1055—Filters bacterial
    • 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
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/07—General characteristics of the apparatus having air pumping means
    • A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073—Syringe, piston type
    • 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
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities

Definitions

  • the present invention relates to the field of medical devices used to facilitate a patient in coughing and expelling tracheobronchial secretions.
  • a serious problem for many patients with neuromuscular weakness including high- level spinal cord injury, as well as many other physical disorders and advanced old age is that they lack sufficient muscle strength and/or muscle control to effect the full inhalation and explosive exhalation required to cough and expel bronchial secretions from the lungs. Inability to remove these secretions can result in bacterial infection (pneumonia) and oxyhemoglobin desaturation (low blood oxygen) and even lead to respiratory failure, hospitalization, and death. These dangers are further intensified in patients with poor muscle control for protecting the airways because they can aspirate saliva, foods, or liquids into their lungs, a dangerous occurrence which can result in the problems noted above.
  • the CoughAssistTM mechanical inexsufflation device facilitates a patient's inhalation and forceful exsufflation to increase cough flows to cough out airway secretions for weak patients.
  • This device dramatically improved the quality of life and care of patients unable to cough effectively, preventing episodes of respiratory failure and, often, the need for invasive mechanical ventilation.
  • the present invention provides a portable and convenient mechanical inexsufflation device to assist patients with inhalation and forceful exsufflation to expel airway debris. It can assist patients in need with respiration as well as for coughing. It is intended for use in various locations and contexts, including, but not limited to, hospitals, ambulances, administration of medical care in third world countries or other places where resources or facilities may be lacking, as well as for personal use.
  • At least one embodiment of the invention provides an inexsufflation device including a hollow body having a substantially closed distal end which defines a fluid port configured to be fluidly connected to a patient interface.
  • a plunger assembly is positioned such that a piston thereof is positioned in the hollow body and sealingly engages an inside surface thereof to define a fluid chamber between the piston and the substantially closed distal end.
  • the plunger assembly is moveable relative to the hollow body to expel fluid in the fluid chamber through the fluid port or draw fluid into the fluid chamber through the fluid port.
  • At least one valve is in fluid communication with the fluid chamber and configured to control a maximum positive or negative pressure within the fluid chamber.
  • FIG. 1 is a perspective view of an exemplary inexsufflation device according to an exemplary embodiment of the invention.
  • FIG. 2 is a perspective view illustrating exemplary components of a patient interface useable with the inexsufflation device of the invention.
  • FIG. 3 is a cross-sectional view of an exemplary inexsufflation device in a ready to use position with the plunger in a mid-volume position.
  • Fig. 4 is a cross-sectional view similar to Fig. 3 illustrating the inexsufflation device after the insufflation stroke.
  • Fig. 5 is a cross-sectional view similar to Fig. 3 illustrating the inexsufflation device after the exsufflation stroke.
  • FIG. 6 is a cross-sectional view of another exemplary inexsufflation device in a ready to use position with the plunger in a full-volume position.
  • Fig. 7 is a cross-sectional view along the line 7-7 in Fig. 6.
  • Fig. 8 is a cross-sectional view similar to Fig. 6 illustrating the inexsufflation device after the insufflation stroke.
  • Fig. 9 is a cross-sectional view similar to Fig. 6 illustrating the inexsufflation device after the exsufflation stroke.
  • distal and proximal refer to the directions “away from” and “closer to,” respectively, the body of the care giver applying the inexsufflation device to a patient.
  • distal refers to the directions “away from” and “closer to,” respectively, the body of the care giver applying the inexsufflation device to a patient.
  • proximal refers to the directions “away from” and “closer to,” respectively, the body of the care giver applying the inexsufflation device to a patient.
  • the terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes a preferred embodiment of the present invention.
  • the present invention provides a portable and convenient mechanical inexsufflation device to assist patients with inhalation and forceful exsufflation to expel airway debris.
  • This portable cough assistance device is comprised of a large syringe that delivers air through an adapter into a face mask or airway tube. It can assist patients in need with respiration as well as for coughing.
  • This device is intended for use in various locations and contexts, including, but not limited to, hospitals, ambulances, administration of medical care in third world countries or other places where resources or facilities may be lacking, as well as for personal use - in one's home, place of work and for travel and as a back up in the event of the failure of the commonly used device, the CoughAssistTM mechanical inexsufflation device (Respironics Int. Inc.).
  • the device 10 includes a hollow body 12 which preferably has a cylindrical configuration.
  • the body 12 extends between a distal end 13 and a proximal end 15.
  • the distal end 13 is substantially closed by end wall 14 but includes a fluid port 17.
  • the fluid port 17 is defined through a stem 16 extending from the end wall 14.
  • the stem 16 is preferably configured for connection to an appropriate oro-nasal patient interface 50 as illustrated in Fig. 2.
  • the stem 16 may connect directly with a portion 52 of the interface 50 or an adapter (not shown) may be provided.
  • the patient interface 50 may be a facemask, a mouthpiece, a lip seal, a tracheostomy tube adapter or any other desired interface component.
  • Fig. 2 also illustrates a bacterial filter 60 which may optionally be connected, for example via connection portion 62, between the stem 16 and the patient interface 50.
  • a finger loop 18 or other handle member is preferably provided adjacent the distal end 13 to allow the care giver to support the distal end 13 of the device 10 while also applying the patient interface 50 to the patient.
  • the substantially open proximal end 15 of the body 12 is closed by a cap 20 with a planar portion 22 and a rim 24 extending therefrom which extends about an outer surface of the body 12.
  • the cap 20 may be secured to the proximal end 15 of the body 12 in any desired manner, for example but not limited to, threaded connection, friction fit or adhesive bonding.
  • the cap 20 includes a through hole 23 for passage of a piston rod 32 of a plunger assembly 30.
  • a piston 34 is positioned on the distal end of the piston rod 32 and is positioned in the internal chamber 21 of the body 12. The piston 34 seals against the inside surface of the body 12 to define a fluid chamber 31 between the piston 34 and the end wall 14.
  • the proximal end of the piston rod 32 extends externally of the cap 20 and includes a handle 36 or the like to facilitate axial movement of the plunger assembly 30 relative to the body 12 to expel air from or draw air into the fluid chamber 31 through fluid port 17.
  • One or more apertures 25 in the cap 20 allow a balancing flow of air into the internal chamber 21 of the body 12.
  • the internal chamber 21 may have any desired volume and in an exemplary
  • the embodiment has a volume of approximately 3 liters which represents the full volume.
  • the plunger assembly 30 is configured such that the starting position of the piston 34, see Fig. 3, may be adjusted such that a patient specific volume of air may be delivered.
  • an adjustment ring 38 is positioned about the piston rod 32 and is adjustable therealong.
  • the adjustment ring 38 may be held relative to the piston rod 32 via a friction fit whereby during set up for a particular patient, the ring 38 is pushed to a position along the piston rod 32 which defines the patient specific volume.
  • ring 38 is positioned approximately half way along the piston 32 such that in the initial position wherein the ring 38 contacts the cap 20, the volume of the fluid chamber 31 is approximately half the full volume, e.g. 1.5 liters if the full volume is 3 liters.
  • the friction fit would be sufficient to maintain the position of the ring 38 relative to the piston rod 32 during use of the device, but allow the ring 38 to be moved during calibration.
  • the adjustment ring may be threadably connected to the piston rod such that rotation of the ring or the rod will cause the ring to move distally or proximally relative to the piston 34.
  • the device 10' in Figs. 6-9 includes a threaded ring 38' and a threaded piston rod 32' .
  • the cap 20' includes a stop member 28 on an inside surface thereof such that the position of the ring 38' along the rod 32' may be adjusted without removing the cap 20' .
  • the stop member 28 and the ring 38' have complementary configurations, for example, octagon, such that the ring 38' may be rotationally held while the piston rod 32' is rotated.
  • the piston rod 32' is moved to until the ring 38' is engaged with the stop member 28 as shown in Fig. 6 and then the rod 32' is rotated until the desired piston position is achieved.
  • the cap 20' could be rotatably secured to the body 12, such that the cap 20' and thereby the ring 38' may be rotated relative to the piston rod 32' which is held stationary.
  • the device 10 further includes a positive venting valve 40 and a negative venting valve 42 at the distal end of the body 12.
  • the positive venting valve 40 is a one-way valve configured to allow flow in a direction from the fluid chamber 31 to outside the body 12 and the negative venting valve 42 is a one-way valve configured to allow flow in a direction from outside the body 12 into the fluid chamber 31. While separate one-way valves are described, it is also possible to utilize a single two-way valve which would provide positive and negative venting.
  • the positive venting valve 40 is preferably set such that as the plunger 30 is moved distally, the positive pressure in the fluid chamber 31 is maintained between
  • the negative venting valve 42 is preferably set such that as the plunger 30 is moved proximally, the negative pressure in the fluid chamber 31 is maintained between approximately 40 to 60 cm H20 and the exhalation flow into the port 17 is between 3.3 to 10 liters/second.
  • the valves 40, 42 may be otherwise configured.
  • the valves 40, 42 may be adjustable such that the pressures and flow rates may be changed for different patients or applications. [0027] Other mechanisms may alternatively or additionally be utilized to control flow rates and pressures.
  • springs or the like may be utilized to control the distal movement of the plunger assembly 30, 30' and/or the proximal movement of the plunger assembly 30, 30' .
  • a linear actuator or the like may be utilized to control or assist the distal movement of the plunger assembly 30, 30' and/or the proximal movement of the plunger assembly 30, 30' .
  • Other elements, for example, the relative configuration of the piston 34 and the body 12 may further be adjusted to assist control of the flow rates and pressures.
  • Fig. 3 illustrates the fluid chamber 31 set to approximately a mid- volume while Fig. 6 illustrates the fluid chamber
  • the care giver, or the patient holds the distal end 13 via the finger loop 18 and applies the patient interface 50 to the patient while the other hand holds the plunger assembly handle 36.
  • the plunger assembly 30 is then moved distally, as indicated by arrows A in Figs. 4 and 8, preferably in consistent motion, such that the piston 34 is driven toward the end wall 14 such that the air in the fluid chamber 31 passes through the port 17, as indicated by arrows B in Figs. 4 and 8, to insufflate the patient's lungs.
  • the piston 34 reaches the end wall 14, the user then moves the plunger assembly 30, 30' proximally, as indicated by arrows C in Figs.
  • the inexsufflation cycle is repeated 4-5 times until all airway debris is expelled and/or the

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention se rapporte à un dispositif d'insufflation-exsufflation comprenant un corps creux ayant une extrémité distale sensiblement fermée qui définit un port de fluide configuré de façon à être raccordé fluidiquement à une interface patient. Dans le dispositif selon l'invention, un ensemble plongeur est placé de telle sorte que son piston soit placé dans le corps creux et mette en prise de façon hermétique une surface intérieure de celui-ci de sorte à définir une chambre de fluide entre le piston et l'extrémité distale sensiblement fermée. L'ensemble plongeur peut se déplacer par rapport au corps creux de sorte à expulser du fluide de la chambre de fluide à travers le port de fluide ou de sorte à aspirer du fluide dans la chambre de fluide à travers le port de fluide. Au moins une vanne est en communication fluidique avec la chambre de fluide, et elle est configurée de façon à réguler une pression positive ou négative à l'intérieur de la chambre de fluide.
PCT/US2012/053431 2011-09-02 2012-08-31 Insufflateur-exsufflateur manuel WO2013033589A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161530641P 2011-09-02 2011-09-02
US61/530,641 2011-09-02

Publications (1)

Publication Number Publication Date
WO2013033589A1 true WO2013033589A1 (fr) 2013-03-07

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PCT/US2012/053431 WO2013033589A1 (fr) 2011-09-02 2012-08-31 Insufflateur-exsufflateur manuel

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016154349A1 (fr) * 2015-03-24 2016-09-29 Ventec Life Systems, Inc. Ventilateur à assistance à la toux intégrée
US10773049B2 (en) 2016-06-21 2020-09-15 Ventec Life Systems, Inc. Cough-assist systems with humidifier bypass
US11191915B2 (en) 2018-05-13 2021-12-07 Ventec Life Systems, Inc. Portable medical ventilator system using portable oxygen concentrators
US11247015B2 (en) 2015-03-24 2022-02-15 Ventec Life Systems, Inc. Ventilator with integrated oxygen production

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5609149A (en) * 1995-10-04 1997-03-11 Takach; Stephen J. Anti-choke device
US6041775A (en) * 1997-10-24 2000-03-28 Southco, Inc. Intrapulmonary aerosolizer
US20040220516A1 (en) * 2002-11-04 2004-11-04 Stephen Solomon Food extraction apparatus and method
US20050005936A1 (en) * 2003-06-18 2005-01-13 Wondka Anthony David Methods, systems and devices for improving ventilation in a lung area
US20050039749A1 (en) * 2003-09-08 2005-02-24 Emerson George P. Insufflation-exsufflation system for removal of broncho-pulmonary secretions with automatic triggering of inhalation phase
US20060249161A1 (en) * 2004-12-09 2006-11-09 Kurt Waters Methods and apparatus for nasal aspiration
US20070017523A1 (en) * 2001-09-16 2007-01-25 Eliezer Be-Eri Inexsufflator
US20070186928A1 (en) * 2005-09-26 2007-08-16 Be Eri Eliezer Combined ventilator inexsufflator
US20090234276A1 (en) * 2004-12-01 2009-09-17 Toles Warren L Needle-free injector

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5609149A (en) * 1995-10-04 1997-03-11 Takach; Stephen J. Anti-choke device
US6041775A (en) * 1997-10-24 2000-03-28 Southco, Inc. Intrapulmonary aerosolizer
US20070017523A1 (en) * 2001-09-16 2007-01-25 Eliezer Be-Eri Inexsufflator
US20040220516A1 (en) * 2002-11-04 2004-11-04 Stephen Solomon Food extraction apparatus and method
US20050005936A1 (en) * 2003-06-18 2005-01-13 Wondka Anthony David Methods, systems and devices for improving ventilation in a lung area
US20050039749A1 (en) * 2003-09-08 2005-02-24 Emerson George P. Insufflation-exsufflation system for removal of broncho-pulmonary secretions with automatic triggering of inhalation phase
US20090234276A1 (en) * 2004-12-01 2009-09-17 Toles Warren L Needle-free injector
US20060249161A1 (en) * 2004-12-09 2006-11-09 Kurt Waters Methods and apparatus for nasal aspiration
US20070186928A1 (en) * 2005-09-26 2007-08-16 Be Eri Eliezer Combined ventilator inexsufflator

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10758699B2 (en) 2015-03-24 2020-09-01 Ventec Life Systems, Inc. Secretion trap
US10245406B2 (en) 2015-03-24 2019-04-02 Ventec Life Systems, Inc. Ventilator with integrated oxygen production
WO2016154349A1 (fr) * 2015-03-24 2016-09-29 Ventec Life Systems, Inc. Ventilateur à assistance à la toux intégrée
US10105509B2 (en) 2015-03-24 2018-10-23 Ventec Life Systems, Inc. Active exhalation valve
US11992619B2 (en) 2015-03-24 2024-05-28 Ventec Life Systems, Inc. Ventilator with integrated cough-assist
US10315002B2 (en) 2015-03-24 2019-06-11 Ventec Life Systems, Inc. Ventilator with integrated oxygen production
US10518059B2 (en) 2015-03-24 2019-12-31 Ventec Life Systems, Inc. Passive leak valve
US11185655B2 (en) 2015-03-24 2021-11-30 Ventec Life Systems, Inc. Passive leak valve
US10046134B2 (en) 2015-03-24 2018-08-14 Ventec Life Systems, Inc. Pressure swing adsorption oxygen generator
US9956371B2 (en) 2015-03-24 2018-05-01 Ventec Life Systems, Inc. Ventilator with integrated cough-assist
US10576237B2 (en) 2015-03-24 2020-03-03 Ventec Life Systems, Inc. Active exhalation valve
US11344692B2 (en) 2015-03-24 2022-05-31 Ventec Life Systems, Inc. Respiratory therapy systems and methods
US11247015B2 (en) 2015-03-24 2022-02-15 Ventec Life Systems, Inc. Ventilator with integrated oxygen production
US11291791B2 (en) 2015-03-24 2022-04-05 Ventee Life Systems, Inc. Ventilator with integrated cough-assist
US11679229B2 (en) 2016-06-21 2023-06-20 Ventec Life Systems, Inc. Cough-assist systems with humidifier bypass
US10773049B2 (en) 2016-06-21 2020-09-15 Ventec Life Systems, Inc. Cough-assist systems with humidifier bypass
US11191915B2 (en) 2018-05-13 2021-12-07 Ventec Life Systems, Inc. Portable medical ventilator system using portable oxygen concentrators

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