EP3934602A1 - Device for selectively regionalizing the ventilation of the lungs towards the posterio-lateral part of the lungs - Google Patents

Device for selectively regionalizing the ventilation of the lungs towards the posterio-lateral part of the lungs

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Publication number
EP3934602A1
EP3934602A1 EP20725812.0A EP20725812A EP3934602A1 EP 3934602 A1 EP3934602 A1 EP 3934602A1 EP 20725812 A EP20725812 A EP 20725812A EP 3934602 A1 EP3934602 A1 EP 3934602A1
Authority
EP
European Patent Office
Prior art keywords
shell
patient
intended
ventilation
invasive
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.)
Granted
Application number
EP20725812.0A
Other languages
German (de)
French (fr)
Other versions
EP3934602B1 (en
EP3934602C0 (en
Inventor
Guillaume CARTEAUX
Armand MEKONTSO DESSAP
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.)
Assistance Publique Hopitaux de Paris APHP
Institut National de la Sante et de la Recherche Medicale INSERM
Universite Paris Est Creteil Paris 12
Original Assignee
Assistance Publique Hopitaux de Paris APHP
Institut National de la Sante et de la Recherche Medicale INSERM
Universite Paris Est Creteil Paris 12
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 Assistance Publique Hopitaux de Paris APHP, Institut National de la Sante et de la Recherche Medicale INSERM, Universite Paris Est Creteil Paris 12 filed Critical Assistance Publique Hopitaux de Paris APHP
Publication of EP3934602A1 publication Critical patent/EP3934602A1/en
Application granted granted Critical
Publication of EP3934602B1 publication Critical patent/EP3934602B1/en
Publication of EP3934602C0 publication Critical patent/EP3934602C0/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00Artificial respiration or heart stimulation, e.g. heart massage
    • A61H31/02"Iron-lungs", i.e. involving chest expansion by applying underpressure thereon, whether or not combined with gas breathing means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00Artificial respiration or heart stimulation, e.g. heart massage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00Artificial respiration or heart stimulation, e.g. heart massage
    • A61H31/004Heart stimulation
    • A61H31/006Power driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00Artificial respiration or heart stimulation, e.g. heart massage
    • A61H31/008Supine patient supports or bases, e.g. improving air-way access to the lungs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00Artificial respiration or heart stimulation, e.g. heart massage
    • A61H2031/001Artificial respiration or heart stimulation, e.g. heart massage fixed on the chest by suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H31/00Artificial respiration or heart stimulation, e.g. heart massage
    • A61H2031/003Artificial respiration or heart stimulation, e.g. heart massage with alternated thorax decompression due to lateral compression
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/12Driving means
    • A61H2201/1238Driving means with hydraulic or pneumatic drive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1602Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1619Thorax
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1602Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165Wearable interfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1683Surface of interface
    • A61H2201/169Physical characteristics of the surface, e.g. material, relief, texture or indicia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00Devices for specific parts of the body
    • A61H2205/08Trunk
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00Devices for specific parts of the body
    • A61H2205/08Trunk
    • A61H2205/084Chest

Definitions

  • the invention relates to a device for the selective regionalization of pulmonary aeration, for selectively surrounding the posterior part of the thoracic cage of a patient, to create a depression therein by means of a negative pressure generator.
  • the invention finds applications in the medical field, and in particular in the field of ventilatory assistance for patients with respiratory pathology associated with inhomogeneous pulmonary lesions.
  • the invention is particularly suitable for the treatment or prevention of acute or chronic respiratory failure.
  • Acute or chronic respiratory failure is a condition affecting several million people around the world. In some cases, the inability of the respiratory system to ensure sufficient oxygenation of the body must be compensated for by ventilatory support.
  • ventilatory support by positive intrathoracic pressure is delivered via an invasive (intubation probe or tracheostomy cannula) or non-invasive (nasal mask, face mask, or helmet) interface, connected to a positive pressure generator.
  • ventilatory assistance by extrathoracic negative pressure is delivered globally via a shell or breastplate (placed on the anterior part of the trunk), a cage or a waterproof garment (notably containing the entire trunk), connected to a negative pressure generator.
  • pulmonary lesions have a clear posterolateral predominance.
  • the overall delivery of ventilation then exposes the risk of non-recruitment of injured areas and overdistension of healthy areas, likely to cause or aggravate the injuries induced by ventilatory assistance ("ventilator-induced lung injury", or VILI). .
  • VILI ventilatory assistance
  • the present invention makes it possible to redistribute in a more homogeneous manner the ventilation delivered by ventilatory assistance and / or naturally by the respiratory muscles, so as to preferentially apply the injured areas, rather than the healthy areas of one or more lungs, in a patient. with respiratory failure most often requiring ventilatory assistance, if their respiratory muscles are unable to ensure sufficient ventilation of the lungs.
  • the object of the invention is to at least partially solve the problem associated with overventilation of healthy areas to the detriment of injured areas in one or both lungs of a patient in need of artificial respiratory assistance.
  • the invention proposes a device allowing the selective regionalization of the distribution of pulmonary aeration, so as to preferentially recruit the damaged areas of a lung during ventilatory assistance or during spontaneous ventilation.
  • the damaged areas of a lung are most often located in the posterolateral part.
  • the invention proposes to create locally a depression capable of promoting the opening and aeration of the damaged posterolateral areas of the lung to make them available to the ventilation delivered by ventilatory assistance (in positive pressure) and / or naturally by the respiratory muscles.
  • the device according to the invention selectively surrounds the dorsal part of the patient's thoracic cage, in a hermetic manner.
  • the space between the patient's body and the device is advantageously filled with a material capable of conforming to the contours of the patient's body and which allows a distance between the negative pressure orifice and the skin of the dorsal wall to be kept as a spacer. (in order to avoid a contact point between the skin of the dorsal wall and the shell at the level of the negative pressure orifice which would generate a depression that is too focal and too strong at this point of contact). A depression is created in this space and in the posterolateral part of the patient's lungs.
  • the device according to the invention is non-invasive and can be used in a hospital or non-hospital environment.
  • the device is molded to the dimensions of the patient, in order to ensure optimum sealing.
  • the device according to the invention can be used alone or in combination with a conventional, invasive or non-invasive ventilatory assistance system.
  • the subject of the invention is therefore a device for selective regionalization of pulmonary aeration, intended to apply a depression on a posterolateral part of the thoracic wall of a patient, said device comprising a rigid or semi-rigid shell, intended in selectively surrounding a posterior part of the chest wall of the patient, and a layer of alveolar material covering an internal wall of the rigid shell, intended to be in contact with the chest wall of the patient, said shell comprising at least one through orifice, intended to be connected to a negative pressure generator.
  • the invention relates to a device for selective regionalization of pulmonary ventilation, intended to apply a depression on a posterolateral part of the thoracic wall of a patient, said device comprising a rigid or semi-rigid shell. , intended to surround a posterior part of the thoracic wall of the patient, and a layer of alveolar material covering an internal wall of the rigid shell, intended to be in contact with the thoracic wall of the patient, said shell comprising at least one through orifice, intended to be connected to a negative pressure generator.
  • the subject of the invention is also a system for applying a localized transpulmonary pressure, said system comprising at least one device for selective regionalization of pulmonary aeration according to the invention, at least one negative pressure generator connected to the device by the through orifice on the shell, so as to impart negative pressure from the generator to the shell and create a depression between the posterior thoracic wall of a patient to which the device is applied and said shell.
  • the subject of the invention is also a ventilatory assistance kit comprising a system for applying localized transpulmonary pressure according to the invention and an invasive or non-invasive artificial ventilation system (operating in positive pressure).
  • the negative pressure generator is able to deliver constant or variable negative pressures.
  • an invasive or non-invasive artificial ventilation system is coupled with the negative pressure generator (s)
  • the invasive or non-invasive artificial ventilation system is capable of delivering constant or variable positive pressures.
  • [Lig 1] schematically represents a cross section of the thoracic cage of a patient with inhomogeneous lesions, with condensation of the posterolateral part of the right and left lungs.
  • FIG. 2 schematically shows side view (A) and top view (B) a device for selective regionalization of pulmonary ventilation according to an example of the invention.
  • [Lig 3] shows a cross section of a device for selective regionalization of pulmonary aeration according to an example of the invention, in position around the dorsal part of the thoracic cage of a patient, a selective increase in pressure transpulmonary in the posterolateral zones which have been represented by arrows (the pulmonary aeration resulting from artificial or spontaneous ventilation is thus better distributed in the posterolateral zones of the two lungs).
  • FIG 4 shows an example of a seal that can be used with the device for selective regionalization of pulmonary ventilation according to the invention.
  • the present invention provides a device intended to selectively surround the posterior (dorsal) part of the thoracic cage of a patient and capable of applying a depression to all or part of the posterior part of said thoracic cage.
  • the term "patient” denotes a mammal, and preferably a human, including an adult, a child or an infant.
  • the term “patient” can also refer to a non-human animal, in particular a non-human primate.
  • the device according to the invention comprises a shell made of rigid or semi-rigid material, forming the structure which will receive the patient's body.
  • the shell is for example plastic such as polypropylene, polyethylene, polyamide, composite material such as glass, carbon, aramid, or resin fibers. It can be modeled for example by thermoforming or three-dimensional printing.
  • the shell preferably has an elliptical shape having a concave curvature to match a contour of the posterior part of the patient's chest wall.
  • the dimensions of the shell are such that the shell covers the posterior and lateral part of the thorax, from the lower costal rim at the bottom to the inter-scapular region at the top at the height of the axillary hollows, and transversely of a line middle axillary to the other.
  • the shell is obtained by molding, taking into account the dimensions of the patient.
  • the shell is obtained by means of a 3D printing scan.
  • the general shape of the shell is such that it hermetically conforms to a contour of the dorsal part of the thoracic wall of the patient, when the patient is lying on said shell.
  • the shape of the shell is such that it makes it possible to receive the dorsal part of the thorax of a patient, from the lower costal edge at the bottom to the inter-scapular region at the height of the axillary hollows at the top and one middle axillary line to another on the sides.
  • the shell thus delimits a volume intended to receive a dorsal and lateral part of the thoracic cage of a patient.
  • a layer of alveolar (or porous) material lines the internal wall of the shell, directed towards the patient's body.
  • the dorsolateral part of the patient's body is therefore in contact with the layer of alveolar material.
  • the layer of cellular material has a structure allowing, when a depression is created in the shell, to distribute the depression evenly over the entire contact surface of the dorsal part of the patient's chest wall.
  • the layer of cellular material is made of polymer, preferably chosen from polyurethane, polyethylene, polyether.
  • the layer of alveolar or cellular material is, for example, a homogenization foam, preferably with open porosity, thus allowing the pores of the foam to be connected to each other and to distribute the negative pressure homogeneously.
  • the foam used has low density and low rigidity, in particular in order to conform to the contours of the dorsal part of the patient.
  • the foam can in particular be a polymeric foam, in particular made of polypropylene or polystyrene.
  • the seal between the hermetic shell and the patient's body is obtained by means of sealing means, extending over a peripheral part of the shell, intended to be placed in sealed abutment against the thoracic wall. of the patient.
  • the sealing means include a seal.
  • the connection between the seal and the shell can also be reinforced with an adhesive.
  • the seal comprises two sealing lips, intended to come into contact with the patient's skin, on either side of the peripheral part of the shell.
  • the shell may have one or more reinforcing grooves, extending over the inner and outer wall of the shell.
  • the cross section of each groove forms a concavity at the level of the internal wall and a convexity at the level of the external wall.
  • at least one reinforcing groove opens into an orifice passing through the shell.
  • the groove or grooves can also be used to suck and evacuate any serosities.
  • the device comprises a central support means, extending longitudinally on the internal wall of the shell, and intended to come into contact with the body of the patient facing the spine.
  • the support means is made of a sufficiently dense and / or resistant material so as not to collapse under the weight of the patient and to support the patient's spine.
  • the central support means is made of waterproof material, capable of hermetically separating the parts of the shell arranged on either side of said central support means when the shell is held around the part. posterior rib cage of the patient.
  • the central support means makes it possible to divide the internal volume of the shell into two parts, in which it is possible to independently create the vacuum.
  • the support means is made of a viscoelastic material, in particular a viscoelastic gel.
  • the device for selective regionalization of the distribution of pulmonary aeration comprises a rigid or semi-rigid hermetic shell, intended to selectively surround a posterior part of the chest wall of the patient, a seal sealing extending over a peripheral part of said shell and intended to be placed in sealed abutment against the chest wall of the patient, a central support means extending transversely on the internal wall of the shell and dividing the shell in two parts, each of the two parts of the shell being lined with a layer of cellular material, the wall of the shell being crossed at each of these parts by an orifice intended to be connected to a negative pressure generator, so that it is possible to create a depression in one and / or the other part of the shell when it is applied to the posterior part of the patient's rib cage.
  • the invention also relates to a system for applying a localized transpulmonary pressure, said system comprising at least one device for selective regionalization of the distribution of pulmonary aeration as described above and at least one connected negative pressure generator. to the device through the through orifice on the shell, so as to impart negative pressure from the generator to the shell and create a depression between the posterior thoracic wall of a patient on which the device is applied and said shell.
  • the device for selective regionalization of the distribution of pulmonary aeration as described above in combination with an invasive or non-invasive artificial ventilation system (which operates in positive pressure) .
  • the device aims to better distribute the pulmonary aeration resulting from the ventilation delivered by ventilatory assistance with an invasive or non-invasive artificial ventilation system in positive pressure, and / or naturally by the respiratory muscles, to preferentially distribute the aeration. in the posterolateral areas of the lungs, by selectively promoting the opening of the alveoli of these usually damaged areas, the latter otherwise remaining (in the state of the known art) occluded to the ventilation generated by an artificial ventilation system and / or naturally by the respiratory muscles.
  • Figure 1 shows a cross section of a thoracic cage of a human patient, lying on his back (supine), vertebrae 6 facing down in the figure.
  • the posterior parts 3 of the lungs are condensed and poorly ventilated (horizontal hatching), being able to undergo opening / closing cycles causing additional lung damage, while the relatively healthy anterior 4 parts (vertical hatching) are overdistended by ventilatory assistance overall.
  • the device 10 overcomes this problem by promoting in a targeted manner the re-aeration of the posterior part of one or both lungs 1, 2 ( Figure 3). More precisely, the dorsal part of the thoracic cage of the patient is housed in the hermetic shell 11, and rests on a homogenization foam 12 lining an internal wall 13 of said shell 11.
  • a vacuum pump (not shown) is connected to the shell 11 hermetic by at least one through orifice 14 formed in the shell 11 ( Figures 2 A & 2B) to create a depression capable of lowering the pleural pressure around the posterior part 3 of the lung and thus increasing the transpulmonary pressure in a localized manner , favoring its re-ventilation.
  • a pressure sensor can be connected to the vacuum pump to monitor the pressure inside the hull.
  • the injured area of the lung can be defined beforehand on the basis of a clinical examination or additional imaging examinations.
  • FIGS. 2A and 2B schematically show an embodiment of a device for selective regionalization of pulmonary aeration 10 towards the postero-lateral zones according to the invention.
  • the shell has a general shape and a curvature, and is made of a rigid or semi-rigid material, allowing to follow the contours of the dorsal part of the thoracic cage of the patient.
  • the shell 11 extends longitudinally from the lower edge of the ribs to the axillary hollow, and transversely to the mid-axillary line.
  • Two through orifices 14 are made on the wall of the hermetic shell 11, on either side of a central longitudinal axis (extending substantially along the spine of the patient housed in the shell) dividing said shell 11 into two side parts 15, 16 substantially equal.
  • a central support means 17 extends longitudinally along the inner wall 13 of the shell 11, so as to physically separate the two side parts 15, 16.
  • the homogenization foam 12 lines each of the side parts 15, 16 from a peripheral contour 18 to the central support means 17.
  • the foam 12 can extend over the entire internal wall 13 of the shell 12, and the means central support 17 covers said foam 12 or is covered by said foam 12.
  • the presence of the central support means 17 allows to potentially divide into two parts the internal volume of the shell 1 1.
  • each part of the shell 11 is provided with a through orifice 14 capable of being connected to a negative pressure generator, it is possible to generate depressions individually in each part or in combination and thus promote the aeration of one or more two lungs.
  • the seal 20 comprises two contact lips 21. , 22 of deformable material making it possible to guarantee the sealing of the connection between the shell 11 and the dorsal part of the thoracic wall, during the depression.
  • the shell 11 is further provided with reinforcing grooves 2, extending longitudinally or transversely on said shell 11.
  • longitudinal grooves extend between the two through holes 14.

Abstract

The invention relates to a device (10) for selectively regionalizing the ventilation of the lungs, which is intended to apply a depression to a posterio-lateral part of the thoracic wall of a patient, said device comprising a rigid or semirigid shell (11) intended to selectively surround a posterior part of the thoracic wall of the patient, and a layer made of a cellular material (12) covering an internal wall (13) of the rigid shell, and intended to be in contact with the thoracic wall of the patient, said shell comprising at least one through-orifice (14) intended to be connected to a generator of negative pressure.

Description

DISPOSITIF DE REGIONALISATION SELECTIVE DE L’AERATION AERATION SELECTIVE REGIONALIZATION SYSTEM
PULMONAIRE VERS LA PARTIE POSTERO LATERALE DES POUMONS PULMONARY TO THE POSTERO LATERAL PART OF THE LUNGS
DOMAINE TECHNIQUE TECHNICAL AREA
L’invention a trait à un dispositif de régionalisation sélective de l’aération pulmonaire, destiné à entourer sélectivement la partie postérieure de la cage thoracique d’un patient, pour y créer une dépression au moyen d’un générateur de pression négative. L’invention trouve des applications dans le domaine médical, et notamment dans le domaine de l’assistance ventilatoire de patients présentant une pathologie respiratoire associée à des lésions pulmonaires inhomogènes. L’invention est particulièrement adaptée pour le traitement ou la prévention de l’insuffisance respiratoire aigüe ou chronique. The invention relates to a device for the selective regionalization of pulmonary aeration, for selectively surrounding the posterior part of the thoracic cage of a patient, to create a depression therein by means of a negative pressure generator. The invention finds applications in the medical field, and in particular in the field of ventilatory assistance for patients with respiratory pathology associated with inhomogeneous pulmonary lesions. The invention is particularly suitable for the treatment or prevention of acute or chronic respiratory failure.
ARRIERE PLAN TECHNOLOGIQUE TECHNOLOGICAL BACKGROUND
L’insuffisance respiratoire aigüe ou chronique est une affection touchant plusieurs millions de personnes à travers le monde. Dans certains cas, l’incapacité de l’appareil respiratoire à assurer une oxygénation suffisante de l’organisme doit être suppléée par une assistance ventilatoire. Acute or chronic respiratory failure is a condition affecting several million people around the world. In some cases, the inability of the respiratory system to ensure sufficient oxygenation of the body must be compensated for by ventilatory support.
Les dispositifs actuels de prise en charge de l’insuffisance respiratoire aigüe ou chronique délivrent de manière globale du gaz dans l’ensemble du volume pulmonaire du patient. Par exemple, l’assistance ventilatoire par pression positive intrathoracique est délivrée via une interface invasive (sonde d’intubation ou canule de trachéotomie) ou non-invasive (masque nasal, facial, ou casque), connectée à un générateur de pression positive. De manière alternative, l’assistance ventilatoire par pression négative extrathoracique est délivrée de manière globale via une coque ou cuirasse (disposée sur la partie antérieure du tronc), une cage ou un vêtement étanche (contenant notamment l’ensemble du tronc), connecté à un générateur de pression négative. Current devices for the management of acute or chronic respiratory failure globally deliver gas throughout the patient's lung volume. For example, ventilatory support by positive intrathoracic pressure is delivered via an invasive (intubation probe or tracheostomy cannula) or non-invasive (nasal mask, face mask, or helmet) interface, connected to a positive pressure generator. Alternatively, ventilatory assistance by extrathoracic negative pressure is delivered globally via a shell or breastplate (placed on the anterior part of the trunk), a cage or a waterproof garment (notably containing the entire trunk), connected to a negative pressure generator.
Or, beaucoup de pathologies respiratoires s’accompagnent d’une atteinte pulmonaire inhomogène. Par exemple, dans le cas des atélectasies post-opératoires, du Syndrome de Détresse Respiratoire Aigüe (SDRA), ou du syndrome thoracique aigu de la drépanocytose adulte, les lésions pulmonaires ont une nette prédominance postéro-latérale. La délivrance globale de la ventilation expose alors au risque de non recrutement des zones lésées et de surdistension des zones saines, susceptibles de provoquer ou d’aggraver les lésions induites par l’assistance ventilatoire (« ventilator-induced lung injury », ou VILI). Ces lésions sont responsables d’une surmortalité chez les patients sous ventilation artificielle. However, many respiratory pathologies are accompanied by inhomogeneous pulmonary involvement. For example, in the case of postoperative atelectasis, Acute Respiratory Distress Syndrome (ARDS), or acute thoracic syndrome of adult sickle cell anemia, pulmonary lesions have a clear posterolateral predominance. The overall delivery of ventilation then exposes the risk of non-recruitment of injured areas and overdistension of healthy areas, likely to cause or aggravate the injuries induced by ventilatory assistance ("ventilator-induced lung injury", or VILI). . These lesions are responsible for excess mortality in patients on artificial ventilation.
Il n’existe pas à ce jour de dispositif qui limite le risque de non recrutement des zones lésées et de surdistension des zones saines. RESUME DE L’INVENTION To date, there is no device that limits the risk of non-recruitment of injured areas and overdistension of healthy areas. SUMMARY OF THE INVENTION
La présente invention permet de redistribuer de manière plus homogène la ventilation délivrée par une assistance ventilatoire et/ou naturellement par les muscles respiratoires, de manière à solliciter préférentiellement les zones lésées, plutôt que les zones saines d’un ou des poumons, chez un patient présentant une insuffisance respiratoire nécessitant le plus souvent une assistance ventilatoire, en cas d’incapacité de leurs muscles respiratoires à assurer une ventilation suffisante des poumons. The present invention makes it possible to redistribute in a more homogeneous manner the ventilation delivered by ventilatory assistance and / or naturally by the respiratory muscles, so as to preferentially apply the injured areas, rather than the healthy areas of one or more lungs, in a patient. with respiratory failure most often requiring ventilatory assistance, if their respiratory muscles are unable to ensure sufficient ventilation of the lungs.
L’invention a pour objectif de résoudre au moins partiellement le problème associé à la surventilation des zones saines au détriment des zones lésées dans un ou les deux poumons d’un patient ayant besoin d’une assistance respiratoire artificielle. Pour cela, l’invention propose un dispositif permettant la régionalisation sélective de la distribution de l’aération pulmonaire, de manière à recruter préférentiellement les zones lésées d’un poumon au cours de l’assistance ventilatoire ou au cours de la ventilation spontanée. D’une manière générale, les zones lésées d’un poumon sont le plus souvent situées dans la partie postéro-latérale. Aussi, l’invention propose de créer localement une dépression susceptible de favoriser l’ouverture et l’aération des zones postéro-latérales lésées du poumon pour les rendre disponibles à la ventilation délivrée par l’assistance ventilatoire (en pression positive) et/ou naturellement par les muscles respiratoires. Pour cela, le dispositif selon l’invention vient entourer sélectivement la partie dorsale de la cage thoracique du patient, de manière hermétique. L’espace entre le corps du patient et le dispositif est avantageusement comblé par un matériau apte à épouser les contours du corps du patient et qui permet de garder telle une entretoise une distance entre l’orifice de pression négative et la peau de la paroi dorsale (afin d’éviter un point contact entre la peau de la paroi dorsale et la coque au niveau de l’orifice de pression négative qui générerait une dépression trop focale et trop forte à ce point de contact). Une dépression est créée dans cet espace et dans la partie postéro-latérale des poumons du patient. Le dispositif selon l’invention est non invasif et peut être utilisé en milieu hospitalier ou non hospitalier. Avantageusement, le dispositif est moulé aux dimensions du patient, afin d’assurer une étanchéité optimum. Le dispositif selon l’invention peut être utilisé seul ou en combinaison avec un système d’assistance ventilatoire classique, invasif ou non-invasif. The object of the invention is to at least partially solve the problem associated with overventilation of healthy areas to the detriment of injured areas in one or both lungs of a patient in need of artificial respiratory assistance. For this, the invention proposes a device allowing the selective regionalization of the distribution of pulmonary aeration, so as to preferentially recruit the damaged areas of a lung during ventilatory assistance or during spontaneous ventilation. In general, the damaged areas of a lung are most often located in the posterolateral part. Also, the invention proposes to create locally a depression capable of promoting the opening and aeration of the damaged posterolateral areas of the lung to make them available to the ventilation delivered by ventilatory assistance (in positive pressure) and / or naturally by the respiratory muscles. For this, the device according to the invention selectively surrounds the dorsal part of the patient's thoracic cage, in a hermetic manner. The space between the patient's body and the device is advantageously filled with a material capable of conforming to the contours of the patient's body and which allows a distance between the negative pressure orifice and the skin of the dorsal wall to be kept as a spacer. (in order to avoid a contact point between the skin of the dorsal wall and the shell at the level of the negative pressure orifice which would generate a depression that is too focal and too strong at this point of contact). A depression is created in this space and in the posterolateral part of the patient's lungs. The device according to the invention is non-invasive and can be used in a hospital or non-hospital environment. Advantageously, the device is molded to the dimensions of the patient, in order to ensure optimum sealing. The device according to the invention can be used alone or in combination with a conventional, invasive or non-invasive ventilatory assistance system.
L’invention a donc pour objet un dispositif de régionalisation sélective de l’aération pulmonaire, destiné à appliquer une dépression sur une partie postéro-latérale de la paroi thoracique d’un patient, ledit dispositif comprenant une coque rigide ou semi-rigide, destinée à entourer sélectivement une partie postérieure de la paroi thoracique du patient, et une couche en matériau alvéolaire recouvrant une paroi interne de la coque rigide, destinée à être en contact avec la paroi thoracique du patient, ladite coque comprenant au moins un orifice traversant, destiné à être relié à un générateur de pression négative. En d’autres termes, l’invention concerne un dispositif de régionalisation sélective de la ventilation pulmonaire, destiné à appliquer une dépression sur une partie postéro-latérale de la paroi thoracique d’un patient, ledit dispositif comprenant une coque rigide ou semi-rigide, destinée à entourer une partie postérieure de la paroi thoracique du patient, et une couche en matériau alvéolaire recouvrant une paroi interne de la coque rigide, destinée à être en contact avec la paroi thoracique du patient, ladite coque comprenant au moins un orifice traversant, destiné à être relié à un générateur de pression négative. The subject of the invention is therefore a device for selective regionalization of pulmonary aeration, intended to apply a depression on a posterolateral part of the thoracic wall of a patient, said device comprising a rigid or semi-rigid shell, intended in selectively surrounding a posterior part of the chest wall of the patient, and a layer of alveolar material covering an internal wall of the rigid shell, intended to be in contact with the chest wall of the patient, said shell comprising at least one through orifice, intended to be connected to a negative pressure generator. In other words, the invention relates to a device for selective regionalization of pulmonary ventilation, intended to apply a depression on a posterolateral part of the thoracic wall of a patient, said device comprising a rigid or semi-rigid shell. , intended to surround a posterior part of the thoracic wall of the patient, and a layer of alveolar material covering an internal wall of the rigid shell, intended to be in contact with the thoracic wall of the patient, said shell comprising at least one through orifice, intended to be connected to a negative pressure generator.
L’invention a également pour objet un système d’application d’une pression transpulmonaire localisée, ledit système comprenant au moins un dispositif de régionalisation sélective de l’aération pulmonaire selon l’invention, au moins un générateur de pression négative relié au dispositif par l’orifice traversant sur la coque, de manière à communiquer une pression négative du générateur à la coque et créer une dépression entre la paroi thoracique postérieure d’un patient sur laquelle le dispositif est appliqué et ladite coque. The subject of the invention is also a system for applying a localized transpulmonary pressure, said system comprising at least one device for selective regionalization of pulmonary aeration according to the invention, at least one negative pressure generator connected to the device by the through orifice on the shell, so as to impart negative pressure from the generator to the shell and create a depression between the posterior thoracic wall of a patient to which the device is applied and said shell.
L’invention a aussi pour objet un kit d’assistance ventilatoire comprenant un système d’application d’une pression transpulmonaire localisée selon l’invention et un système de ventilation artificielle invasive ou non invasive (fonctionnant en pression positive). The subject of the invention is also a ventilatory assistance kit comprising a system for applying localized transpulmonary pressure according to the invention and an invasive or non-invasive artificial ventilation system (operating in positive pressure).
Avantageusement, le générateur de pression négative est apte à délivrer des pressions négatives constantes ou variables. Advantageously, the negative pressure generator is able to deliver constant or variable negative pressures.
Avantageusement, un système de ventilation artificielle invasive ou non invasive est couplé avec le ou les générateurs de pression négative Advantageously, an invasive or non-invasive artificial ventilation system is coupled with the negative pressure generator (s)
Avantageusement, le système de ventilation artificielle invasive ou non invasive, est apte à délivrer des pressions positives constantes ou variables Advantageously, the invasive or non-invasive artificial ventilation system is capable of delivering constant or variable positive pressures.
DESCRIPTION DES DESSINS DESCRIPTION OF THE DRAWINGS
[Lig 1] représente de manière schématique une coupe transversale de la cage thoracique d’un patient présentant des lésions inhomogènes, avec condensation de la partie postéro-latérale des poumons droit et gauche. [Lig 1] schematically represents a cross section of the thoracic cage of a patient with inhomogeneous lesions, with condensation of the posterolateral part of the right and left lungs.
[Lig 2] représente de manière schématique vue de côté (A) et vue de dessus (B) un dispositif de régionalisation sélective de l’aération pulmonaire selon un exemple de l’invention. [Lig 2] schematically shows side view (A) and top view (B) a device for selective regionalization of pulmonary ventilation according to an example of the invention.
[Lig 3] représente une coupe transversale d’un dispositif de régionalisation sélective de l’aération pulmonaire selon un exemple de l’invention, en position autour de la partie dorsale de la cage thoracique d’un patient, une augmentation sélective de la pression transpulmonaire dans les zones postero-latérales ayant été représentée par des flèches (l’aération pulmonaire issue de la ventilation artificielle ou spontanée est ainsi mieux répartie dans les zones postero- latérales des deux poumons). [Lig 3] shows a cross section of a device for selective regionalization of pulmonary aeration according to an example of the invention, in position around the dorsal part of the thoracic cage of a patient, a selective increase in pressure transpulmonary in the posterolateral zones which have been represented by arrows (the pulmonary aeration resulting from artificial or spontaneous ventilation is thus better distributed in the posterolateral zones of the two lungs).
[Fig 4] représente un exemple de joint d’étanchéité pouvant être utilisé avec le dispositif de régionalisation sélective de l’aération pulmonaire selon l’invention. [Fig 4] shows an example of a seal that can be used with the device for selective regionalization of pulmonary ventilation according to the invention.
DESCRIPTION DETAILLEE DE L’INVENTION DETAILED DESCRIPTION OF THE INVENTION
La présente invention propose un dispositif destiné à entourer sélectivement la partie postérieure (dorsale) de la cage thoracique d’un patient et apte à appliquer une dépression sur tout ou partie de la partie postérieure de ladite cage thoracique. Dans le contexte de l’invention, le terme « patient » désigne un mammifère, et préférentiellement un humain, y compris un adulte, un enfant ou un nourrisson. Le terme « patient » peut également désigner un animal non humain, en particulier un primate non humain. The present invention provides a device intended to selectively surround the posterior (dorsal) part of the thoracic cage of a patient and capable of applying a depression to all or part of the posterior part of said thoracic cage. In the context of the invention, the term "patient" denotes a mammal, and preferably a human, including an adult, a child or an infant. The term “patient” can also refer to a non-human animal, in particular a non-human primate.
Le dispositif selon l’invention comprend une coque en matériau rigide ou semi rigide, formant la structure qui va recevoir le corps du patient. La coque est par exemple en plastique tel que le polypropylène, polyéthylène, polyamide, en matériau composite tel que des fibres de verre, de carbone, d’aramide, ou en résine. Elle peut être modelée par exemple par thermoformage ou impression trois dimensions. Selon l’invention, la coque a préférentiellement une forme elliptique présentant une courbure concave pour épouser un contour de la partie postérieure de la paroi thoracique du patient. Avantageusement, les dimensions de la coque sont telles que la coque recouvre la partie postérieure et latérale du thorax, depuis le rebord costal inférieur en bas jusqu’à la région inter-scapulaire en haut à hauteur des creux axillaires, et transversalement d’une ligne axillaire moyenne à l’autre. The device according to the invention comprises a shell made of rigid or semi-rigid material, forming the structure which will receive the patient's body. The shell is for example plastic such as polypropylene, polyethylene, polyamide, composite material such as glass, carbon, aramid, or resin fibers. It can be modeled for example by thermoforming or three-dimensional printing. According to the invention, the shell preferably has an elliptical shape having a concave curvature to match a contour of the posterior part of the patient's chest wall. Advantageously, the dimensions of the shell are such that the shell covers the posterior and lateral part of the thorax, from the lower costal rim at the bottom to the inter-scapular region at the top at the height of the axillary hollows, and transversely of a line middle axillary to the other.
Avantageusement, la coque est obtenue par moulage, en tenant compte des dimensions du patient. Par exemple, la coque est obtenue au moyen d’un scan à impression 3D. Bien entendu, il est possible de réaliser une coque avec des dimensions dites « standards », destinée à être utilisée pour plusieurs patients présentant une morphologie globalement semblable. Par exemple, il est possible de prévoir différentes dimensions de coques (large, moyenne, étroite, etc.) adaptée à des catégories différentes de patients. Advantageously, the shell is obtained by molding, taking into account the dimensions of the patient. For example, the shell is obtained by means of a 3D printing scan. Of course, it is possible to produce a shell with so-called “standard” dimensions, intended to be used for several patients having a generally similar morphology. For example, it is possible to provide different shell dimensions (wide, medium, narrow, etc.) adapted to different categories of patients.
La forme générale de la coque est telle qu’elle épouse de façon hermétique un contour de la partie dorsale de la paroi thoracique du patient, lorsque le patient est allongé sur ladite coque. Avantageusement, la forme de la coque est telle qu’elle permet de recevoir la partie dorsale du thorax d’un patient, depuis le rebord costal inférieur en bas jusqu’à la région inter-scapulaire à hauteur des creux axillaires en haut et d’une ligne axillaire moyenne à l’autre sur les côtés. La coque délimite ainsi un volume destiné à recevoir une partie dorsale et latérale de la cage thoracique d’un patient. The general shape of the shell is such that it hermetically conforms to a contour of the dorsal part of the thoracic wall of the patient, when the patient is lying on said shell. Advantageously, the shape of the shell is such that it makes it possible to receive the dorsal part of the thorax of a patient, from the lower costal edge at the bottom to the inter-scapular region at the height of the axillary hollows at the top and one middle axillary line to another on the sides. The shell thus delimits a volume intended to receive a dorsal and lateral part of the thoracic cage of a patient.
Une couche en matériau alvéolaire (ou poreux) tapisse la paroi interne de la coque, dirigée vers le corps du patient. La partie dorso-latérale du corps du patient est donc en contact avec la couche en matériau alvéolaire. Selon l’invention, la couche en matériau alvéolaire présente une structure permettant, lorsqu’une dépression est créée dans la coque, de répartir de manière homogène la dépression sur toute la surface de contact de la partie dorsale de la paroi thoracique du patient. Dans un mode de réalisation, la couche en matériau alvéolaire est en polymère, préférentiellement choisi parmi le polyuréthane, le polyéthylène, le polyéther. La couche en matériau alvéolaire, ou cellulaire, est par exemple une mousse d’homogénéisation, préférentiellement à porosité ouverte permettant ainsi aux pores de la mousse d’être reliés les uns aux autres et de répartir de manière homogène la dépression. Préférentiellement, la mousse utilisée présente une faible densité et une faible rigidité, afin notamment d’épouser les contours de la partie dorsale du patient. La mousse peut notamment être une mousse polymérique, notamment en polypropylène ou polystyrène. A layer of alveolar (or porous) material lines the internal wall of the shell, directed towards the patient's body. The dorsolateral part of the patient's body is therefore in contact with the layer of alveolar material. According to the invention, the layer of cellular material has a structure allowing, when a depression is created in the shell, to distribute the depression evenly over the entire contact surface of the dorsal part of the patient's chest wall. In one embodiment, the layer of cellular material is made of polymer, preferably chosen from polyurethane, polyethylene, polyether. The layer of alveolar or cellular material is, for example, a homogenization foam, preferably with open porosity, thus allowing the pores of the foam to be connected to each other and to distribute the negative pressure homogeneously. Preferably, the foam used has low density and low rigidity, in particular in order to conform to the contours of the dorsal part of the patient. The foam can in particular be a polymeric foam, in particular made of polypropylene or polystyrene.
Dans un mode de réalisation, l’étanchéité entre la coque hermétique et le corps du patient est obtenue grâce à des moyens d’étanchéité, s’étendant sur une partie périphérique de la coque, destinée à être mise en appui étanche contre la paroi thoracique du patient. Par exemple, les moyens d’étanchéité comprennent un joint d’étanchéité. La liaison entre le joint et la coque peut en outre être renforcée par une colle. Dans un mode de réalisation particulier, le joint d’étanchéité comprend deux lèvres d’étanchéité, destinées à venir en contact de la peau du patient, de part et d’autre de la partie périphérique de la coque. In one embodiment, the seal between the hermetic shell and the patient's body is obtained by means of sealing means, extending over a peripheral part of the shell, intended to be placed in sealed abutment against the thoracic wall. of the patient. For example, the sealing means include a seal. The connection between the seal and the shell can also be reinforced with an adhesive. In a particular embodiment, the seal comprises two sealing lips, intended to come into contact with the patient's skin, on either side of the peripheral part of the shell.
Selon l’invention, la coque peut présenter une ou plusieurs rainures de renforcement, s’étendant sur la paroi interne et externe de la coque. Avantageusement, la section transversale de chaque rainure dessine une concavité au niveau de la paroi interne et une convexité au niveau de la paroi externe. Avantageusement, au moins une rainure de renforcement débouche dans un orifice traversant de la coque. Ainsi, la ou les rainures peuvent également servir à aspirer et évacuer d’éventuelles sérosités. According to the invention, the shell may have one or more reinforcing grooves, extending over the inner and outer wall of the shell. Advantageously, the cross section of each groove forms a concavity at the level of the internal wall and a convexity at the level of the external wall. Advantageously, at least one reinforcing groove opens into an orifice passing through the shell. Thus, the groove or grooves can also be used to suck and evacuate any serosities.
Dans un mode de réalisation, le dispositif comprend un moyen de soutien central, s’étendant longitudinalement sur la paroi interne de la coque, et destiné à venir en contact avec le corps du patient en regard de la colonne vertébrale. Avantageusement, le moyen de soutien est en un matériau suffisamment dense et/ou résistant pour ne pas s’écraser sous le poids du patient et soutenir la colonne vertébrale du patient. Par exemple, le moyen de soutien central est en matériau étanche, apte à séparer hermétiquement les parties de la coque disposées de part et d’autre dudit moyen de soutien central lorsque la coque est maintenue autour de la partie postérieure de la cage thoracique du patient. Ainsi, le moyen de soutien central permet de diviser en deux parties le volume interne de la coque, dans lesquelles il est possible de créer indépendamment le vide. Par exemple, le moyen de soutien est en matériau viscoélastique, notamment un gel viscoélastique. In one embodiment, the device comprises a central support means, extending longitudinally on the internal wall of the shell, and intended to come into contact with the body of the patient facing the spine. Advantageously, the support means is made of a sufficiently dense and / or resistant material so as not to collapse under the weight of the patient and to support the patient's spine. For example, the central support means is made of waterproof material, capable of hermetically separating the parts of the shell arranged on either side of said central support means when the shell is held around the part. posterior rib cage of the patient. Thus, the central support means makes it possible to divide the internal volume of the shell into two parts, in which it is possible to independently create the vacuum. For example, the support means is made of a viscoelastic material, in particular a viscoelastic gel.
Selon un mode de réalisation particulier, le dispositif de régionalisation sélective de la distribution de l’aération pulmonaire selon l’invention comprend une coque rigide ou semi- rigide hermétique, destinée à entourer sélectivement une partie postérieure de la paroi thoracique du patient, un joint d’étanchéité s’étendant sur une partie périphérique de ladite coque et destiné à être mis en appui étanche contre la paroi thoracique du patient, un moyen de soutien central s’étendant transversalement sur la paroi interne de la coque et divisant la coque en deux parties, chacune des deux parties de la coque étant tapissée d’une couche en matériau alvéolaire, la paroi de la coque étant traversée au niveau de chacune de ces parties d’un orifice destiné à être relié à un générateur de pression négative, de sorte qu’il est possible de créer une dépression dans l’une et/ou l’autre des partie de la coque lorsqu’elle est appliquée sur la partie postérieure de la cage thoracique du patient. According to a particular embodiment, the device for selective regionalization of the distribution of pulmonary aeration according to the invention comprises a rigid or semi-rigid hermetic shell, intended to selectively surround a posterior part of the chest wall of the patient, a seal sealing extending over a peripheral part of said shell and intended to be placed in sealed abutment against the chest wall of the patient, a central support means extending transversely on the internal wall of the shell and dividing the shell in two parts, each of the two parts of the shell being lined with a layer of cellular material, the wall of the shell being crossed at each of these parts by an orifice intended to be connected to a negative pressure generator, so that it is possible to create a depression in one and / or the other part of the shell when it is applied to the posterior part of the patient's rib cage.
L’invention concerne également un système d’application d’une pression transpulmonaire localisée, ledit système comprenant au moins un dispositif de régionalisation sélective de la distribution de l’aération pulmonaire tel que décrit ci-dessus et au moins un générateur de pression négative relié au dispositif par l’orifice traversant sur la coque, de manière à communiquer une pression négative du générateur à la coque et créer une dépression entre la paroi thoracique postérieure d’un patient sur laquelle le dispositif est appliqué et ladite coque. The invention also relates to a system for applying a localized transpulmonary pressure, said system comprising at least one device for selective regionalization of the distribution of pulmonary aeration as described above and at least one connected negative pressure generator. to the device through the through orifice on the shell, so as to impart negative pressure from the generator to the shell and create a depression between the posterior thoracic wall of a patient on which the device is applied and said shell.
Selon l’invention, il est possible d’utiliser le dispositif de régionalisation sélective de la distribution de l’aération pulmonaire tel que décrit ci-dessus en combinaison avec un système de ventilation artificielle invasive ou non invasive, (qui fonctionne en pression positive). According to the invention, it is possible to use the device for selective regionalization of the distribution of pulmonary aeration as described above in combination with an invasive or non-invasive artificial ventilation system (which operates in positive pressure) .
Ainsi, le dispositif vise à mieux répartir l’aération pulmonaire issue de la ventilation délivrée par une assistance ventilatoire avec un système de ventilation artificielle invasive ou non invasive en pression positive, et/ou naturellement par les muscles respiratoires, pour distribuer préférentiellement l’aération dans les zones postéro-latérales des poumons, en favorisant sélectivement l’ouverture des alvéoles de ces zones habituellement lésées, ces dernières restant sinon (dans l’état de l’art connu) occluses à la ventilation générée par un système de ventilation artificielle et/ou naturellement par les muscles respiratoires. Thus, the device aims to better distribute the pulmonary aeration resulting from the ventilation delivered by ventilatory assistance with an invasive or non-invasive artificial ventilation system in positive pressure, and / or naturally by the respiratory muscles, to preferentially distribute the aeration. in the posterolateral areas of the lungs, by selectively promoting the opening of the alveoli of these usually damaged areas, the latter otherwise remaining (in the state of the known art) occluded to the ventilation generated by an artificial ventilation system and / or naturally by the respiratory muscles.
L’invention sera mieux comprise à la lecture de la description qui suit et à l’examen des figures qui l’accompagnent. Comme exposé ci-dessus, certains patients en insuffisance respiratoire présentent des lésions inhomogènes des poumons. La figure 1 représente une coupe transversale d’une cage thoracique d’un patient humain, allongé sur le dos (en décubitus dorsal), vertèbres 6 vers le bas sur la figure. Les parties postérieures 3 des poumons sont condensées et mal aérées (hachures horizontales), pouvant subir des cycles d’ouverture/fermeture engendrant des lésions pulmonaires supplémentaires, alors que les parties antérieures 4 relativement saines (hachures verticales) sont surdistendues par l’assistance ventilatoire globale. The invention will be better understood on reading the following description and on examining the accompanying figures. As explained above, certain patients with respiratory failure present inhomogeneous lesions of the lungs. Figure 1 shows a cross section of a thoracic cage of a human patient, lying on his back (supine), vertebrae 6 facing down in the figure. The posterior parts 3 of the lungs are condensed and poorly ventilated (horizontal hatching), being able to undergo opening / closing cycles causing additional lung damage, while the relatively healthy anterior 4 parts (vertical hatching) are overdistended by ventilatory assistance overall.
Le dispositif 10 selon l’invention permet de pallier à ce problème en favorisant de façon ciblée la ré-aération de la partie postérieure d’un ou des deux poumons 1, 2 (figure 3). Plus précisément, la partie dorsale de la cage thoracique du patient est logée dans la coque 11 hermétique, et repose sur une mousse d’homogénéisation 12 tapissant une paroi interne 13 de ladite coque 11. Une pompe à vide (non représentée) est connectée à la coque 11 hermétique par au moins un orifice traversant 14 ménagé dans la coque 11 (figures 2 A &2B) pour créer une dépression susceptible de faire baisser la pression pleurale autour de la partie postérieure 3 du poumon et ainsi augmenter la pression transpulmonaire de manière localisée, favorisant sa ré-aération. Un capteur de pression peut être connecté à la pompe à vide pour surveiller la pression à l’intérieur de la coque. The device 10 according to the invention overcomes this problem by promoting in a targeted manner the re-aeration of the posterior part of one or both lungs 1, 2 (Figure 3). More precisely, the dorsal part of the thoracic cage of the patient is housed in the hermetic shell 11, and rests on a homogenization foam 12 lining an internal wall 13 of said shell 11. A vacuum pump (not shown) is connected to the shell 11 hermetic by at least one through orifice 14 formed in the shell 11 (Figures 2 A & 2B) to create a depression capable of lowering the pleural pressure around the posterior part 3 of the lung and thus increasing the transpulmonary pressure in a localized manner , favoring its re-ventilation. A pressure sensor can be connected to the vacuum pump to monitor the pressure inside the hull.
La zone lésée du poumon peut être définie préalablement sur la base d’un examen clinique ou d’examens complémentaires d’imagerie. The injured area of the lung can be defined beforehand on the basis of a clinical examination or additional imaging examinations.
Les figures 2A et 2B montrent de manière schématique un exemple de réalisation d’un dispositif de régionalisation sélective de l’aération pulmonaire 10 vers les zones postéro-latérales selon l’invention. La coque l i a une forme générale et une courbure, et est en matériau rigide ou semi-rigide, permettant d’épouser les contours de la partie dorsale de la cage thoracique du patient. Avantageusement, la coque 11 s’étend longitudinalement depuis le bord inférieur des côtes jusqu’au creux axillaire, et transversalement jusqu’à la ligne médio-axillaire. Deux orifices traversant 14 sont ménagés sur la paroi de la coque 11 hermétique, de part et d’autre d’un axe longitudinal central (s’étendant sensiblement le long de la colonne vertébrale du patient logé dans la coque) divisant ladite coque 11 en deux parties latérales 15, 16 sensiblement égales. Dans un mode de réalisation, tel que représenté à la figure 3, un moyen de soutien central 17 s’étend longitudinalement le long de la paroi interne 13 de la coque 11, de manière à séparer physiquement les deux parties latérales 15, 16. La mousse d’homogénéisation 12 tapisse chacune des parties latérales 15, 16 depuis un contour périphérique 18 jusqu’au moyen de soutien central 17. Alternativement, la mousse 12 peut s’étendre sur toute la paroi interne 13 de la coque 12, et le moyen de soutien central 17 recouvre ladite mousse 12 ou est recouvert par ladite mousse 12. La présence du moyen de soutien central 17 permet de diviser de manière potentiellement hermétique en deux parties le volume interne de la coque 1 1. Ainsi, si chaque partie de la coque 11 est munie d’un orifice traversant 14 apte à être relié à un générateur de pression négative, il est possible d’engendrer des dépressions individuellement dans chaque partie ou en combinaison et ainsi favoriser l’aération d’un ou des deux poumons. FIGS. 2A and 2B schematically show an embodiment of a device for selective regionalization of pulmonary aeration 10 towards the postero-lateral zones according to the invention. The shell has a general shape and a curvature, and is made of a rigid or semi-rigid material, allowing to follow the contours of the dorsal part of the thoracic cage of the patient. Advantageously, the shell 11 extends longitudinally from the lower edge of the ribs to the axillary hollow, and transversely to the mid-axillary line. Two through orifices 14 are made on the wall of the hermetic shell 11, on either side of a central longitudinal axis (extending substantially along the spine of the patient housed in the shell) dividing said shell 11 into two side parts 15, 16 substantially equal. In one embodiment, as shown in Figure 3, a central support means 17 extends longitudinally along the inner wall 13 of the shell 11, so as to physically separate the two side parts 15, 16. The homogenization foam 12 lines each of the side parts 15, 16 from a peripheral contour 18 to the central support means 17. Alternatively, the foam 12 can extend over the entire internal wall 13 of the shell 12, and the means central support 17 covers said foam 12 or is covered by said foam 12. The presence of the central support means 17 allows to potentially divide into two parts the internal volume of the shell 1 1. Thus, if each part of the shell 11 is provided with a through orifice 14 capable of being connected to a negative pressure generator, it is possible to generate depressions individually in each part or in combination and thus promote the aeration of one or more two lungs.
Le contour périphérique 18 de la coque 11 , lorsque celle-ci est en position autour de la partie dorsale du patient, vient se coller hermétiquement à la peau du patient, de manière à créer un volume hermétiquement fermé. Afin de permettre cette liaison hermétique, il est possible de fixer un joint d’étanchéité sur le contour périphérique 18 de la coque 11. Dans un mode de réalisation, tel que représenté à la figure 4, le joint 20 comprend deux lèvres de contact 21, 22 en matériau déformable permettant de garantir l’étanchéité de la liaison entre la coque 11 et la partie dorsale de la paroi thoracique, lors de la dépression. The peripheral contour 18 of the shell 11, when the latter is in position around the dorsal part of the patient, comes to adhere hermetically to the skin of the patient, so as to create a hermetically sealed volume. In order to allow this hermetic connection, it is possible to fix a seal on the peripheral outline 18 of the shell 11. In one embodiment, as shown in FIG. 4, the seal 20 comprises two contact lips 21. , 22 of deformable material making it possible to guarantee the sealing of the connection between the shell 11 and the dorsal part of the thoracic wall, during the depression.
Lors de la mise en dépression de la coque 11 , une dépression est engendrée localement dans le volume interne entre la coque 11 hermétique et la paroi de la cage thoracique du patient grâce à l’étanchéité de la liaison. Cette dépression permet de faire baisser la pression pleurale et augmenter la pression transpulmonaire localement afin de favoriser l’aération de la partie postérieure d’un ou des deux poumons en regard de la coque. When the shell 11 is placed under vacuum, a low pressure is generated locally in the internal volume between the hermetic shell 11 and the wall of the patient's rib cage thanks to the tightness of the connection. This depression helps to lower pleural pressure and increase transpulmonary pressure locally to promote aeration of the posterior part of one or both lungs facing the shell.
La coque 11 est en outre munie de rainures de renforcement 2, s’étendant longitudinalement ou transversalement sur ladite coque 11. Dans l’exemple représenté aux figures 2A et 2B, des rainures longitudinales s’étendent entre les deux orifices traversant 14. Ainsi, des sérosités peuvent être drainées par les rainures 23 et aspirées par les trous 14. The shell 11 is further provided with reinforcing grooves 2, extending longitudinally or transversely on said shell 11. In the example shown in Figures 2A and 2B, longitudinal grooves extend between the two through holes 14. Thus, serosities can be drained through the grooves 23 and aspirated through the holes 14.

Claims

REVENDICATIONS
1. Dispositif (10) de régionalisation sélective de l’aération pulmonaire issue de la ventilation délivrée par une assistance ventilatoire avec un système de ventilation artificielle invasive ou non invasive, et/ou naturellement par les muscles respiratoires, pour patient présentant une pathologie respiratoire associée à des lésions pulmonaires inhomogènes, destiné à être utilisé avec au moins un générateur de pression négative pour générer une dépression sur la partie postéro-latérale de la paroi thoracique, ledit dispositif comprenant une coque rigide ou semi-rigide (11), comprenant : 1. Device (10) for selective regionalization of the pulmonary aeration resulting from the ventilation delivered by ventilatory assistance with an invasive or non-invasive artificial ventilation system, and / or naturally by the respiratory muscles, for patients presenting an associated respiratory pathology to inhomogeneous pulmonary lesions, intended for use with at least one negative pressure generator to generate a depression on the posterolateral part of the chest wall, said device comprising a rigid or semi-rigid shell (11), comprising:
• une forme définissant un volume destiné à loger et épouser les contours de la partie dorsale du patient, lorsque le patient est allongé sur ladite coque (11), • a shape defining a volume intended to accommodate and follow the contours of the dorsal part of the patient, when the patient is lying on said shell (11),
• au moins un orifice traversant (14), destiné à être relié à un générateur de pression négative, • at least one through orifice (14), intended to be connected to a negative pressure generator,
• un contour périphérique hermétique (18), destiné à être mis en appui hermétique contre la peau de la partie dorsale du patient, • a hermetic peripheral contour (18), intended to be placed in hermetic support against the skin of the dorsal part of the patient,
• une paroi interne (13) délimitée par le contour périphérique hermétique (18) , formant le volume logeant la partie dorsale de la paroi thoracique du patient et dans lequel est maintenue la dépression, • an internal wall (13) delimited by the hermetic peripheral contour (18), forming the volume housing the dorsal part of the chest wall of the patient and in which the depression is maintained,
• et une couche en matériau alvéolaire tapissant la paroi interne (13) de la coque rigide (11) pour épouser les contours du corps du patient, et qui est destinée à être en contact avec la peau de la partie dorsale, la dépression générée dans la partie dorsale logée dans le dispositif de manière hermétique, permettant de favoriser par l’augmentation locale de la pression transpulmonaire l’aération des régions lésées du ou des poumons dans la zone postéro-latérale et ainsi de redistribuer de manière plus homogène l’aération pulmonaire issue de la ventilation. • and a layer of alveolar material lining the internal wall (13) of the rigid shell (11) to match the contours of the patient's body, and which is intended to be in contact with the skin of the dorsal part, the depression generated in the dorsal part housed in the device in a hermetic manner, making it possible to promote by the local increase in the transpulmonary pressure the aeration of the damaged regions of the lung (s) in the posterolateral zone and thus to redistribute the aeration more homogeneously pulmonary from ventilation.
2. Dispositif selon la revendication 1, caractérisé en ce que la couche en matériau alvéolaire présente une structure permettant, lorsqu’une dépression est créée dans la coque (11), de répartir de manière homogène la dépression sur toute la surface. 2. Device according to claim 1, characterized in that the layer of cellular material has a structure allowing, when a vacuum is created in the shell (11), to distribute the vacuum evenly over the entire surface.
3. Dispositif selon Tune des revendications 1 à 2, caractérisé en ce que la couche en matériau alvéolaire est une mousse d’homogénéisation à porosité ouverte. 3. Device according to one of claims 1 to 2, characterized in that the layer of cellular material is a homogenization foam with open porosity.
4. Dispositif selon Tune des revendications 1 à 3, caractérisé en ce que la couche en matériau alvéolaire est en polymère, préférentiellement choisi parmi le polyuréthane, le polyéthylène, le polyéther. 4. Device according to one of claims 1 to 3, characterized in that the layer of cellular material is made of polymer, preferably chosen from polyurethane, polyethylene, polyether.
5. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce que la coque (11) a une forme elliptique présentant une courbure concave pour épouser un contour de la partie postérieure de la paroi thoracique du patient. 5. Device according to any one of the preceding claims, characterized in that the shell (11) has an elliptical shape having a concave curvature to conform to a contour of the posterior part of the chest wall of the patient.
6. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce que la couche en matériau alvéolaire tapisse toute la coque interne (11) et est délimitée par la coque interne (11) et le contour périphérique (18) 6. Device according to any one of the preceding claims, characterized in that the layer of cellular material lines the entire inner shell (11) and is delimited by the inner shell (11) and the peripheral outline (18)
7. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce que le contour périphérique (18) comprend des moyens d’étanchéité (20) s’étendant sur le contour de la partie périphérique (18) de la coque, et destinés à être mis en appui étanche contre la peau de la partie dorsale du patient dans la région postéro-latérale de la paroi thoracique. 7. Device according to any one of the preceding claims, characterized in that the peripheral contour (18) comprises sealing means (20) extending over the contour of the peripheral part (18) of the shell, and intended to be placed tightly against the skin of the dorsal part of the patient in the posterolateral region of the thoracic wall.
8. Dispositif selon la revendication 7, caractérisé en ce que les moyens d’étanchéité comprennent un joint d’étanchéité (20), ledit joint d’étanchéité étant avantageusement muni de deux lèvres d’étanchéité (21, 22), destinées à venir en contact de la peau du patient, de part et d’autre de la partie périphérique (18) de la coque. 8. Device according to claim 7, characterized in that the sealing means comprise a seal (20), said seal being advantageously provided with two sealing lips (21, 22), intended to come in contact with the patient's skin, on either side of the peripheral part (18) of the shell.
9. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce que la coque (11) présente plusieurs orifices traversants (14) situés pour répartir de façon homogène la dépression dans la coque (11). 9. Device according to any one of the preceding claims, characterized in that the shell (11) has several through openings (14) located to evenly distribute the depression in the shell (11).
10. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce que la coque (11) est munie d’au moins une rainure de renforcement (23) dont la section transversale dessine une concavité au niveau de la paroi interne (13) et une convexité au niveau de la paroi externe de la coque (11). 10. Device according to any one of the preceding claims, characterized in that the shell (11) is provided with at least one reinforcing groove (23), the cross section of which forms a concavity at the level of the internal wall (13). and a convexity at the outer wall of the shell (11).
11. Dispositif selon la revendication 10, caractérisé en ce que la rainure de renforcement débouche dans un orifice traversant (14) de la coque (11). 11. Device according to claim 10, characterized in that the reinforcing groove opens into a through orifice (14) of the shell (11).
12. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce qu’il comprend un moyen de soutien central (17), positionné transversalement sur la paroi interne (13) de la coque (11), et destiné à venir en contact avec le corps du patient en s’étendant longitudinalement en regard de la colonne vertébrale. 12. Device according to any one of the preceding claims, characterized in that it comprises a central support means (17), positioned transversely on the internal wall (13) of the shell (11), and intended to come into contact. with the patient's body extending longitudinally facing the spine.
13. Dispositif selon la revendication 12, caractérisé en ce que le moyen de soutien central (17) est en matériau étanche et divise hermétiquement ladite coque (11) en deux parties latérales (15, 16), étant ainsi apte à séparer hermétiquement les parties latérales (15, 16) de la coque disposées de part et d’autre dudit moyen de soutien central (17) lorsque la coque est maintenue autour de la partie dorsale de la paroi thoracique du patient, la mousse (12) tapissant chacune des parties latérales (15, 16) depuis le contour périphérique (18) jusqu’au moyen de soutien central (17), chaque partie de la coque (11) étant munie d’au moins un orifice traversant (14) apte à être relié à un générateur de pression négative, permettant d’engendrer des dépressions individuelles dans chaque partie ou en combinaison, et ainsi favoriser l’aération de la partie postéro-latérale d’un ou des deux poumons. 13. Device according to claim 12, characterized in that the central support means (17) is made of sealed material and hermetically divides said shell (11) into two lateral parts (15, 16), thus being able to hermetically separate the parts. sides (15, 16) of the shell disposed on either side of said central support means (17) when the shell is held around the dorsal portion of the patient's chest wall, the foam (12) each lining side parts (15, 16) from the peripheral contour (18) to the central support means (17), each part of the shell (11) being provided with at least one through hole (14) suitable for connection to a negative pressure generator, making it possible to generate individual depressions in each part or in combination, and thus promote aeration of the posterolateral part of one or both lungs.
14. Dispositif selon l’une quelconque des revendications précédentes, caractérisé en ce que la coque (11) s’étend longitudinalement depuis le bord inférieur des côtes jusqu’au creux axillaire, et transversalement jusqu’à la ligne médio-axillaire. 14. Device according to any one of the preceding claims, characterized in that the shell (11) extends longitudinally from the lower edge of the ribs to the axillary hollow, and transversely to the mid-axillary line.
15. Système d’application d’une pression transpulmonaire localisée, ledit système comprenant au moins : 15. System for applying localized transpulmonary pressure, said system comprising at least:
• un dispositif de régionalisation sélective de la distribution de l’aération pulmonaire dans la partie postéro-latérale des poumons selon l’une des revendications 1 à 14,• a device for selective regionalization of the distribution of pulmonary aeration in the posterolateral part of the lungs according to one of claims 1 to 14,
• au moins un générateur de pression négative relié au dispositif par l’orifice traversant (14) sur la coque (11), de manière à communiquer une pression négative du générateur à la coque et créer une dépression entre la paroi thoracique postérieure d’un patient sur laquelle le dispositif est appliqué et ladite coque. • at least one negative pressure generator connected to the device by the through orifice (14) on the shell (11), so as to communicate a negative pressure from the generator to the shell and create a depression between the posterior thoracic wall of a patient on which the device is applied and said shell.
16. Système selon la revendication 15, caractérisé en ce que le générateur de pression négative est apte à délivrer des pressions négatives constantes ou variables 16. System according to claim 15, characterized in that the negative pressure generator is able to deliver constant or variable negative pressures.
17. Kit d’assistance ventilatoire comprenant : 17. Ventilation assistance kit comprising:
• un système d’application d’une pression transpulmonaire localisée selon l’une des revendications 15 à 16, et • a system for applying localized transpulmonary pressure according to one of claims 15 to 16, and
• un système de ventilation artificielle invasive ou non invasive. • an invasive or non-invasive artificial ventilation system.
18. Kit d’assistance ventilatoire selon la revendication 17, dans lequel un système de ventilation artificielle invasive ou non invasive est couplé avec le ou les générateurs de pression négative 18. Ventilation assistance kit according to claim 17, wherein an invasive or non-invasive artificial ventilation system is coupled with the negative pressure generator (s)
19. Kit d’assistance ventilatoire selon l’une des revendications 17 à 18, dans lequel le système de ventilation artificielle invasive ou non invasive, est apte à délivrer des pressions positives constantes ou variables 19. Ventilation assistance kit according to one of claims 17 to 18, in which the system of invasive or non-invasive artificial ventilation is capable of delivering constant or variable positive pressures
EP20725812.0A 2019-03-04 2020-03-03 Device for selectively regionalizing the ventilation of the lungs towards the posterio-lateral part of the lungs Active EP3934602B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1902190A FR3093433B1 (en) 2019-03-04 2019-03-04 SELECTIVE LUNG VENTILATION REGIONALIZATION DEVICE
PCT/FR2020/050421 WO2020178521A1 (en) 2019-03-04 2020-03-03 Device for selectively regionalizing the ventilation of the lungs towards the posterio-lateral part of the lungs

Publications (3)

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EP3934602A1 true EP3934602A1 (en) 2022-01-12
EP3934602B1 EP3934602B1 (en) 2023-08-23
EP3934602C0 EP3934602C0 (en) 2023-08-23

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US (1) US20220054354A1 (en)
EP (1) EP3934602B1 (en)
FR (1) FR3093433B1 (en)
WO (1) WO2020178521A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB470611A (en) * 1936-12-23 1937-08-18 Rudolf Eisenmenger Improvements relating to apparatus for promoting respiration
US2648331A (en) * 1950-02-01 1953-08-11 Bennett Vivian Ray Means for applying artificial respiration
US2707948A (en) * 1953-12-18 1955-05-10 John H Emerson Chest respirator
US2853998A (en) * 1955-02-28 1958-09-30 John H Emerson Respirator casing and methods of producing the same
EP3128987A4 (en) * 2014-04-07 2017-11-22 The Penn State Research Foundation Neonatal chest splint for applying negative distending pressure
US10478375B2 (en) * 2015-09-25 2019-11-19 Peter Antros Pulmonary expansion therapy devices
TWI678198B (en) * 2017-11-28 2019-12-01 財團法人工業技術研究院 Adjustable respirator shell

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US20220054354A1 (en) 2022-02-24
FR3093433A1 (en) 2020-09-11
WO2020178521A4 (en) 2020-11-12
EP3934602B1 (en) 2023-08-23
WO2020178521A1 (en) 2020-09-10
FR3093433B1 (en) 2023-06-23
EP3934602C0 (en) 2023-08-23

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