WO2014124953A1 - Embout buccal de ventilation non invasif et kit de raccordement d'un tel embout buccal - Google Patents

Embout buccal de ventilation non invasif et kit de raccordement d'un tel embout buccal Download PDF

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Publication number
WO2014124953A1
WO2014124953A1 PCT/EP2014/052700 EP2014052700W WO2014124953A1 WO 2014124953 A1 WO2014124953 A1 WO 2014124953A1 EP 2014052700 W EP2014052700 W EP 2014052700W WO 2014124953 A1 WO2014124953 A1 WO 2014124953A1
Authority
WO
WIPO (PCT)
Prior art keywords
mouthpiece
tubular body
patient
noninvasive ventilation
diffuser
Prior art date
Application number
PCT/EP2014/052700
Other languages
English (en)
Inventor
David ORLIKOWSKI
Original Assignee
Institut National De La Sante Et De La Recherche Medicale (Inserm)
Assistance Publique - Hopitaux De Paris
Universite Versailles Saint-Quentin-En-Yvelines
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 Institut National De La Sante Et De La Recherche Medicale (Inserm), Assistance Publique - Hopitaux De Paris, Universite Versailles Saint-Quentin-En-Yvelines filed Critical Institut National De La Sante Et De La Recherche Medicale (Inserm)
Publication of WO2014124953A1 publication Critical patent/WO2014124953A1/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
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/049—Mouthpieces
    • A61M16/0493—Mouthpieces with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
    • 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
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0418—Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation

Definitions

  • This invention relates to a mouthpiece to be used during noninvasive ventilation (NIV) for both chronic and acute respiratory failure.
  • NMV noninvasive ventilation
  • This invention also relates to a kit which can be used for connecting an air supply apparatus to the mouth of the patient and which includes, amongst others, such a mouthpiece.
  • Noninvasive ventilation has been used for several years in order to provide a patient with breathing air coming from an air supply system, such as a ventilator.
  • An air supply system such as a ventilator.
  • a key issue for this kind of ventilation assistance is not to hurt the patient, while allowing him or her to breathe easily.
  • US-A-2004/0221846 and US-A-2010/01 13956 disclose a nasal and cannula breathing detection device for monitoring breathing of a patient.
  • Such a device includes a mouthpiece which is not designed to be used for non invasive ventilation.
  • the invention aims at solving this problem with a new noninvasive ventilation mouthpiece which is more comfortable for the patient than known mouthpieces and which can be kept in the mouth of the patient for a long period of time, without inducing orthodontic deformities.
  • the invention concerns a noninvasive ventilation mouthpiece comprising a first end, provided with connection means for connecting the mouthpiece to a gas supply system, a second end, to be placed in a patient's mouth during use of the mouthpiece, and a tubular body joining the first and second ends.
  • the tubular body includes at least a flexible portion and the second end is adjustable in one or several directions with respect to the first end, via bending of the flexible portion.
  • the actual geometry of the mouthpiece can be adapted to the morphology of the patient, to his or her habits and to the position of the gas supply system outlet with respect to the head of the patient. Since the second end of the tubular body is adjustable with respect to the first end, it is possible to bend the flexible portion in order to set the shape of the mouthpiece, in accordance to its actual conditions of use.
  • the mouthpiece might incorporate one or several of the following features, taken in any technically admissible configuration:
  • the flexible portion is made in PVC.
  • the tubular body has a maximum outer transverse dimension between 5 and 10 mm and a maximum inner transverse dimension between 2 and 4 mm.
  • the mouthpiece includes a bendable stiffening member which extends along the tubular body.
  • the stiffening member is a metallic wire, preferably made of copper.
  • the flexible portion extends continuously between the first end and the second end.
  • the second end is equipped with a gas diffuser.
  • This diffuser preferably includes a base crown adapted to be mounted on an end of the tubular body and several elastically deformable fingers which extends from the base crown along directions parallel to a central longitudinal axis of the diffuser.
  • an axial length of the diffuser is between 15 and 20 mm and a maximum diameter of an envelope surface including respective outer surfaces of the fingers is smaller than 15 mm, preferably equal to 10 mm.
  • connection means include a connector provided with a socket, for accommodating an end of the tubular body, and a pipe portion adapted to be connected to a gas supply unit, the socket and the pipe portion being in permanent fluid communication.
  • the tubular body has a length of less than 250 mm, preferably less than 200 mm, still preferably of about 150 mm.
  • the tubular body has a length of more than 500 mm, preferably more than 800 mm, still preferably of about 1000 mm.
  • the invention also concerns a kit for connecting an air supply apparatus to the mouth of a patient, this kit comprising a noninvasive ventilation mouthpiece as mentioned here-above and fixation means for positioning the tubular body of this mouthpiece with respect to the patient and/or to a part in the vicinity of the patient.
  • the fixation means include at least one clamp.
  • the fixation means include a harness to be worn by the patient and which defines at least a passage opening for the tubular body.
  • FIG. 1 is an exploded perspective view of a mouthpiece according to the invention
  • FIG. 2 is a perspective view of the mouthpiece of figure 1 in use, in a first configuration
  • FIG. 3 is an enlarged cut view along a plane III on figure 2;
  • figure 4 is perspective view similar to figure 2 when the mouthpiece is in a second configuration of use;
  • FIG. 5 is an enlarged perspective view of an air diffuser of the mouthpiece of figure 1 and
  • figure 6 is a front view of the diffuser of figure 5.
  • the noninvasive ventilation mouthpiece 10 represented on the figures includes a single connector 12 which forms a first end of the mouthpiece, a single diffuser or tip member 14 which forms a second end of the mouthpiece and a single flexible tube or tubular body 16 which connects the connector 12 to the diffuser 14.
  • Connector 12 includes a base plate 122, a socket 124 and a sleeve 126 forming a pipe portion.
  • Sleeve 126 is used to connect mouthpiece 10 to a source of air under pressure, such as a ventilator 20.
  • the external diameter of sleeve 126 which has a cylindrical cross-section, is adapted to the internal dimensions of an outlet of a non represented circuit of ventilator 20.
  • Socket 124 also has a cylindrical cross-section and d124 denotes its internal diameter.
  • a through hole extends through base plate 122 and permanently connects the inside volume of socket 124 and the inside volume of sleeve 126.
  • Connector 12 is made of a single piece of plastic material, such as polyethylene.
  • X12 denotes a central axis of connector 12.
  • Diffuser 14 is made of a single piece of a soft material such as silicone or a natural or synthetic elastomer.
  • Diffuser 14 includes a crown 142 and six fingers 144 regularly distributed around a central axis X14 of diffuser 14. Fingers 144 are parallel to axis X14 and extend from crown 142 along directions parallel to axis X14. Notches 146 are defined between the fingers 144.
  • the geometry and the material of diffuser 14 allow fingers 144 to elastically deform when they are bitten by a patient or when they come into contact with the teeth, the tongue or the cheeks inside the mouth of a patient. Because of its deformability, diffuser 14 can be kept in the mouth of a patient for a long period of time.
  • L14 denotes the axial length of diffuser 14, that is its length along axis X14.
  • L14 is chosen between 15 and 20 mm.
  • Diffuser 14 has a shape centered on axis X14 and D14 denotes the maximum diameter of an envelope surface S14 which includes the respective outer surfaces of fingers 144.
  • Diameter D14 is the maximum transverse dimension of diffuser 14. Its value is chosen smaller than 15 mm, preferably equal to 10 mm.
  • diffuser 14 can have an oval transverse shape or a so called « flat » shape.
  • the maximum transverse dimension of diffuser 14 is also chosen less than 15 mm, preferably equal to 10 mm.
  • Tube 16 can be qualified as a "straw”. It extends along a central axis X16 between a first end 162 and a second end 164 which are respectively introduced within socket 124 of connector 12 and within crown 142 of diffuser 14.
  • tube 16 has a globally circular cross-section with a lateral extension 166.
  • the circular portion of tube 16 has an outer diameter D16 which has a value equal to the value of diameter d124.
  • the first end 162 of tube 16 can be tightly fitted within socket 124, thanks to a localized deformation of socket 124, in order to accommodate extension 166.
  • the internal diameter of crown 142 is adapted to accommodate the second end 164 of tube 16, thanks to a localized deformation.
  • a copper wire 168 extends along tube 16, within extension 166. Thus, wire 168 is accessible neither from outside tube 16 nor from the internal volume V16 of this tube.
  • Tube 16 is made of a synthetic flexible material, namely PVC or polyvinyl chloride.
  • tube 16 can also be made of any plastic material suitable for medical use.
  • W16 denotes the maximum width of tube 16, which is taken at the level of extension 166. Width W16 is larger than diameter D16. In practice, width W16 is between 5 and 10 mm, whereas diameter D16 is between 4 and 8 mm. Volume V16 has a cylindrical cross- section and d16 denotes the internal diameter of tube 16. Diameter d16 has a value between 2 and 4 mm.
  • the diameters D16 and d16 and the width W16 can be increased respectively up to 15 mm, 1 1 mm and 18 mm.
  • wire 168 gives some stiffness to tube 16, so that this tube can be shaped according to the needs, in particular according to the morphology of the patient and/or to the location of the ventilator with respect to the patient's head.
  • the length L16 of the tube 16 is chosen with a value of less than 250 mm, preferably less than 200 mm. Some good results can be obtained with a tube of 150 mm in length.
  • the ventilator 20 is located in the vicinity of the patient's head and the tube 16 can extend freely between the connector 12 and the mouth of the patient.
  • tube 16 can be bended in different directions in order take into account the actual location of ventilator 20 and to place diffuser 14 in the mouth of the patient, without hurting the patient and/or deforming his/her teeth. Since tube 16 is flexible, it is easy for the patient or for a medical staff to shape tube 16 to the actual needs. Once tube 16 has been shaped according to the needs, wire 168 keeps tube 16 in the desired configuration.
  • the diameter d16 and length L16 of tube 16 can be chosen on the basis of the patients' morphology and handicap. In other words, selecting a tube 16 with given diameter and length allows adapting mouthpiece 10 to the patient, in particular to his/her potential orthopedic deformities.
  • Axis X16 is curved in the configurations of figures 2 and 4.
  • Axis X12 and X16 are superimposed at the level of first end 162, whereas axis X14 and X16 are superimposed at the level of second end 164.
  • the position of axis X14 can be adjusted with respect to axis X12 by proper bending and shaping of tube 16 along several directions, as shown by arrows F1 and F2, which represent some bending possibilities of tube 16.
  • An angle a defined between axes X12 and X14 changes its value from about 90 ° in the configuration of figure 2 to about 135° in theconfiguration of figure 4. Actually, angle a can take any value between about 30° and 180° .
  • the orientation of diffuser 14 with respect to axis X12 can also be changed by a rotation of first end 162 within socket 124.
  • tube 16 has a single concavity.
  • tube 16 can be shaped with an inflexion point, e.g. with an S shape.
  • the length L16 of tube 16 can be larger than 500 mm, preferably larger than 800 mm. Good results can be obtained with a tube of 1 m in length. This is appropriate when ventilator 20 is located, for instance, on the back of a wheel chair. Under such circumstances, a path must be defined between the ventilator and the mouth of the patient and some non represented fixation means are used for positioning the tube 16 with respect to the patient and/or with respect to a part in its vicinity, for instance the back rest or an arm rest of the wheel chair. To this end, some clamps can be used to immobilize the tube 16 with respect to the wheel chair or to the cloths of the patient.
  • the patient can wear a non represented harness which defines one or several passage openings for the tube 16, so that this tube is guided along the patient's body from ventilator 20 to the mouth of the patient.
  • tube 16 Since tube 16 is flexible, it can be shaped to follow the prescribed path, along the patient's body or along the wheel chair and it will substantially keep the desired configuration thanks to the stiffening effect obtained by the wire 168. On the other hand, since tube 16 is flexible, it cannot hurt the patient even if it is located close to its body.
  • Clamps and harness can also be used together and/or with a mouthpiece including a relatively short tube, like the one represented on the figures.
  • the mouthpiece 10 of the invention can be used for a long period of time, e.g. between eight and sixteen hours, during day time and it is compatible with some movements of the patient's head, with speech and possibly with feeding.
  • the diffuser can be kept in the patient's mouth for a long period of time, even during speech and feeding.
  • the patient can easily move diffuser 14 within his or her mouth, thanks to the flexibility of tube 16.
  • a connector different from connector 12 can be used, provided that it allows to feed tube 16 with air at a desired pressure.
  • no connector is used and the first end 162 of tube 16 is directly plugged onto an outlet opening of ventilator 20, provided that this outlet has a shape adapted to this purpose.
  • diffuser 14 The actual shape and material of diffuser 14 can be changed, provided that it remains compatible with a long stay in the mouth of the patient.
  • another source of air under pressure can be used, instead of ventilator 20.
  • the invention is compatible with an "active" system where the patient sucks air from mouthpiece 10 when needed. It is also compatible with a « passive » system where air is continuously provided, which is the case with ventilator 20.
  • a gas different from air can be provided with via mouthpiece 10.
  • tube 16 is flexible and extends continuously between connector 12 and diffuser 14. Alternatively, only a part of tube 16 can be flexible. This is in particular useful when the length L16 of tube 16 is important, e.g. larger than 500 mm.
  • the stiffening member of tube 16 could be a made in a metal different from copper or in a non metallic material, such as a semi-rigid plastic material or carbon.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Otolaryngology (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)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne un embout buccal de ventilation non invasif (10) qui comprend une première extrémité, pourvue de moyens de raccordement (12) pour raccorder l'embout buccal à un système d'alimentation de gaz (20), une deuxième extrémité (14), destinée à être placée dans la bouche d'un patient pendant l'utilisation de l'embout buccal, et un corps tubulaire (16) reliant les première et deuxième extrémités. Le corps tubulaire (16) comprend au moins une partie flexible et la deuxième extrémité (14) est ajustable dans une ou plusieurs directions (F1, F2) par rapport à la première extrémité (12), par flexion de la partie flexible.
PCT/EP2014/052700 2013-02-12 2014-02-12 Embout buccal de ventilation non invasif et kit de raccordement d'un tel embout buccal WO2014124953A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13305167 2013-02-12
EP13305167.2 2013-02-12

Publications (1)

Publication Number Publication Date
WO2014124953A1 true WO2014124953A1 (fr) 2014-08-21

Family

ID=47790117

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2014/052700 WO2014124953A1 (fr) 2013-02-12 2014-02-12 Embout buccal de ventilation non invasif et kit de raccordement d'un tel embout buccal

Country Status (1)

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WO (1) WO2014124953A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040043356A1 (en) * 2002-07-08 2004-03-04 Herbert Schlussel Saliva ejector
US20040221846A1 (en) * 2001-01-04 2004-11-11 Curti James N. Nasal and oral cannula breathing detection device
US20100016908A1 (en) * 2008-04-15 2010-01-21 Martin Ruth E Swallowing Air Pulse Therapy Mouthpiece and Method for the Use Thereof
US20100113956A1 (en) * 1997-04-29 2010-05-06 Salter Labs Nasal cannula for acquiring breathing information
US20120271187A1 (en) * 2011-01-27 2012-10-25 Frankie Michelle Mcneill Method and device for monitoring carbon dioxide

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100113956A1 (en) * 1997-04-29 2010-05-06 Salter Labs Nasal cannula for acquiring breathing information
US20040221846A1 (en) * 2001-01-04 2004-11-11 Curti James N. Nasal and oral cannula breathing detection device
US20040043356A1 (en) * 2002-07-08 2004-03-04 Herbert Schlussel Saliva ejector
US20100016908A1 (en) * 2008-04-15 2010-01-21 Martin Ruth E Swallowing Air Pulse Therapy Mouthpiece and Method for the Use Thereof
US20120271187A1 (en) * 2011-01-27 2012-10-25 Frankie Michelle Mcneill Method and device for monitoring carbon dioxide

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