EP4237053A1

EP4237053A1 - Intraoral device for oxygenation of a patient

Info

Publication number: EP4237053A1
Application number: EP21810726.6A
Authority: EP
Inventors: Nicolas Barbe; Jérémie POURCHEZ; Yoann MONTIGAUD
Original assignee: Centre Hospitalier Universitaire; Institut Mines Telecom IMT
Current assignee: Centre Hospitalier Universitaire; Institut Mines Telecom IMT
Priority date: 2020-10-29
Filing date: 2021-10-28
Publication date: 2023-09-06
Also published as: FR3115702A1; WO2022090979A1

Abstract

The invention relates to an intraoral device configured to be inserted into the buccal vestibule of a patient, the device comprising: - a curved, oval end piece having: • a central portion (11), • a peripheral portion (12) on the lateral edges of the central portion (11), - a tubular element (2) configured to be connected to an oxygen source, the central portion (11) having a first radius of curvature (R_c) and the peripheral portion (12) having a second peripheral radius of curvature (R_p), the first radius of curvature (R_c) being greater than the second radius of curvature (R_p), characterised in that the rear central and peripheral surfaces are smooth.

Description

INTRAORAL DEVICE FOR PATIENT OXYGENATION

FIELD OF THE INVENTION

The present invention relates to the general technical field of medical devices for the oxygenation of a patient. More specifically, the present invention relates to an intraoral device that can be inserted into the mouth of a patient suffering from trismus and having a limited or even non-existent mouth opening.

BACKGROUND OF THE INVENTION

Various devices for oxygenating a patient have already been proposed.

Document WO 2005/097245 describes a respiratory mask comprising:

an oval, curved intraoral tip configured to fit between the lips and gums of a patient, the intraoral tip extending between a first side edge and a second side edge, the intraoral tip including a convex outer face for to come opposite the patient's lips, a concave internal face intended to come opposite the patient's gums, and a central through light,
a tubular member having proximal and distal ends, the proximal end being mounted in the central through lumen of the intraoral tip for the passage of airflow so that the distal end of the tubular member extends projecting outward from convex outer face.

The mask according to WO 2005/097245 can be inserted into the mouth of a patient with a limited mouth opening.

However, such a mask has drawbacks. In particular, gas leaks may appear at the interface between the intraoral tip and the patient's lips.

Furthermore, due to its considerable height, the mask according to WO 2005/097245 is liable to cause discomfort for the patient.

Document FR 2 700 473 describes an intra-oral respiratory mouthpiece having a vestibulo-lingual plug extending projecting from the rear face of the upper and lower vestibules.

Document WO 2016/098099 describes a sealable mouthpiece whose proximal and distal flanges extend over the entire periphery of a dome part in a continuous manner.

US 3,107,667 discloses a mouthpiece bearing dental impressions projecting from the rear face of the outermost area of said mouthpiece.

These devices are incompatible with a population having a zero/greatly reduced mouth opening due to the impossibility of inserting it between the upper and lower dental arches in a position of zero/heavily reduced mouth opening (trismus).

Indeed, the presence of the vestibulo-lingual tampon on the respiratory mouthpiece presented in document FR 2 700 473 makes it impossible to insert the latter in a person with trismus.

Similarly, US 3,107,667 teaches to provide a custom molded device from the user's dentition, which makes it impossible for people with trismus to insert it.

In WO 2016/098099, the height of the device is "preferably 56 mm", while the average mouth opening in the population is 50 mm. It is therefore suitable for the general population, but not for the target population for the mouth opening is nil or reduced, because its insertion would become traumatic or even impossible due to the morphological mismatch between the vestibular space and the device.

An object of the present invention is to propose an intraoral device making it possible to overcome the aforementioned drawbacks.

BRIEF DESCRIPTION OF THE INVENTION

To this end, the invention provides an intraoral device configured to be inserted into the oral cavity of a patient, the device comprising:

a tip configured to be inserted into the vestibule of the oral cavity, the tip including an oval and curved body having:

a central part having a through opening, the central part having:

a central front face adapted to extend facing the lips of the patient, and

a central rear face adapted to extend facing the patient's teeth, and

a peripheral part composed of a pair of fins each extending over a respective lateral edge of the central part, the peripheral part having:

a peripheral front face adapted to extend facing the inner faces of the patient's cheeks, and

a peripheral rear face adapted to extend facing the patient's teeth,
a tubular element having proximal and distal ends, the proximal end being fixed in the through opening of the central part and the distal end projecting from the front face,

the central rear face having a first radius of curvature and the peripheral rear face having a second peripheral radius of curvature, the first radius of curvature being greater than the second radius of curvature,

characterized in that the central and peripheral rear faces are smooth.

Preferred but non-limiting aspects of the intraoral device according to the invention are the following:

the central front face may comprise upper and lower grooves extending in a direction going from one of the peripheral fins to the other of the peripheral fins, the upper groove being configured to receive the upper lip of the patient, and the lower groove being configured to receive the patient's lower lip;
each fin can join a respective side edge of the central part at a respective edge, the distance between the edges being between 30 and 60 millimeters, preferably between 40 and 50 millimeters;
the distance between the fins of the peripheral part can be between 40 and 80 millimeters, preferably between 50 and 70 millimeters, and even more preferably between 55 and 65 millimeters, in particular substantially equal to 60 millimeters;
the height of the central and peripheral parts can be between 15 and 25 millimeters;
the tubular element can extend along a longitudinal axis A-A', the distance between the free end of each fin and the point of the central part closest to the distal end of the tubular element being between 40 and 60 millimeters, preferably between 45 and 55 millimeters, and even more preferably between 48 and 50 millimeters, in particular substantially equal to 49 millimeters;
the thickness of each fin can be between 1 and 10 millimeters, preferably between 2 and 6 millimeters, and even more preferably between 3 and 5 millimeters, in particular substantially equal to 4 millimeters;
the central and peripheral parts can be made of a material having a shore hardness between 10 and 70 Shore A, preferably between 20 and 60 Shore A, and even more preferably between 30 and 50 Shore A;
the central front face may be curved so that said central front face is shaped along first and second curvatures corresponding to first and second directions orthogonal to each other and perpendicular to the longitudinal axis A-A'.

Other advantages and characteristics of the device according to the invention will emerge better from the following description of several variant embodiments, given by way of non-limiting examples, from the appended drawings in which:

the is a top view representation of the intraoral device according to the invention,
the is a representation in top view of a tip of the intraoral device,
the is a longitudinal cross-sectional view of the intraoral device of the ,
the is a schematic representation of central and peripheral parts of the tip,
the is a perspective view of a tubular member of the intraoral device.

DETAILED DESCRIPTION OF THE INVENTION

Various examples of the intraoral device will now be described with reference to the figures. In these various figures, the equivalent elements are designated by the same reference numeral.

General

With reference to the , a variant embodiment of an intraoral device according to the invention has been illustrated. The intraoral device includes:

a tip 1 configured to be inserted into a vestibule of a patient's oral cavity,
a tubular element 2 intended to be connected to an oxygenation apparatus for the emission of a gas into the oral cavity of the patient.

The intraoral device has an overall Y shape. It extends globally along a longitudinal axis A-A' forming an axis of revolution for the tubular element 2.

In the following, the different dimensions of the device will be given relative to the longitudinal axis A-A' and to a plane P of symmetry of the device containing the longitudinal axis A-A'. In particular in the context of the present invention:

the longitudinal axis A-A' defines a "depth" of the intraoral device,
a sagittal axis B-B' perpendicular to the longitudinal axis A-A' and contained in the plane P defines a "height" of the intraoral device,
a transverse axis C-C' perpendicular to the plane P defines a "width" of the intraoral device.

Furthermore, in the context of the following description, we mean:

"back face" , a face intended to come opposite the teeth of a patient
"front face" , a face opposite the rear face intended to come opposite the patient's cheeks and lips, the central part of the front face extending opposite the lips, and the peripheral part extending opposite the patient's cheeks.

Finally the terms “upper” and “lower” are used with reference to the position of the tubular element:

an element being qualified as "lower" when it is closer to the patient's chin than to the nose once the device has been inserted into the patient's mouth,
an element is qualified as “superior” when it is closer to the patient's nose than to the chin once the device is inserted into the patient's mouth.

Tip

The tip 1 comprises an oval and curved body composed of a central part 11 and a peripheral part 12. The height of the central 11 and peripheral 12 parts (dimension along the sagittal axis B-B') is between 15 and 25 millimeters. This makes it possible to limit the discomfort associated with the insertion of the endpiece 1 in the mouth of the patient, in particular when the mouth opening of the patient is limited or non-existent.

The tip 1 also includes a through opening 13 formed in the center of the body. More specifically, this through opening 13 extends between the front 14 and rear 15 faces of the central part of the body. This through opening 13 defines a conduit for the passage of a gas to the oral cavity of the patient.

The central and peripheral parts 11, 12 of the end piece 1 are preferably made of a flexible material, that is to say a material whose Shore hardness is between 10 and 70 Shore A, preferably between 20 and 60 Shore A, and even more preferably between 30 and 50 Shore A. This makes it possible to have a tip 1 that is sufficiently rigid to facilitate its insertion into the patient's mouth, while being flexible enough to conform to the contour of the arch dental.

The material constituting the tip 1 is for example a medical grade polymer (polyethylene, polypropylene, polycarbonate, etc.), a medical grade elastomer, a silicone, a polyurethane, an epoxy, a parylene.

The thickness of the central and peripheral parts 11, 12 is advantageously between 1 and 10 millimeters, preferably between 2 and 6 millimeters, and even more preferably between 3 and 5 millimeters, in particular substantially equal to 4 millimeters. The inventors have in fact discovered that these ranges of thickness make it possible to minimize the risk of gas leaking at the level of the patient's mouth when the device is inserted into the oral cavity and a gas is injected through the tubular element. 2.

Central part

When the device is inserted into the oral cavity, the central part 11 extends between the patient's lips and teeth. More specifically, the central part 11 includes:

a central front face 14 adapted to extend facing the lips of the patient, and
a central rear face 15 adapted to extend facing the patient's teeth.

The front face 14 of the central part can be curved in two directions to adapt to the shape of the patient's mouth and thus limit the risk of leakage during the injection of gas through the intraoral device.

Advantageously, upper and lower grooves 17 can be made in the front face 14 of the central part. These grooves 17 extend transversely to the central part between its side edges. Each groove 17 is configured to receive a respective lip of the patient:

the upper groove is intended to receive the upper lip of the patient,
the lower groove is intended to receive the lower lip of the patient.

The presence of upper and lower grooves 17 in the central front face 14 makes it possible to limit discomfort for the patient while limiting the risks of leakage during the injection of gas through the intraoral device.

Advantageously, the rear face 15 of the central part 11 is smooth. The fact that the rear face 15 of the central part 11 has no component extending protruding allows the insertion of the intraoral device in the mouth of a patient whose mouth opening does not exist.

As shown in , the rear face of the central part 11 has a first radius of curvature R _c . This first radius of curvature R _c is chosen to conform the rear face of the central part 11 to the curvature of the dental arch portion delimited by the patient's canines.

Peripheral part

The peripheral part 12 is composed of two fins each extending from a respective side edge of the central part 11. In particular, each fin joins a respective side edge of the central part at the level of a respective edge 18. Thus, the free end 16 of each fin corresponds to the area of the fin closest to the bottom of the oral cavity when the device is inserted into the patient's mouth.

Preferably, the distance L between the edges is between 30 and 60 millimeters, preferably between 40 and 50 millimeters. This allows a fine adaptation of the tip 1 to the morphology of the patient's mouth.

When the device is inserted into the oral cavity, the peripheral part 12 extends between the cheeks and the teeth of the patient. More precisely :

the front faces 14 of the fins are configured to extend facing the inner faces of the patient's cheeks, and
the rear faces 15 of the fins are configured to extend opposite the teeth (in particular the canines and premolars) of the patient.

As shown in , the rear face of the peripheral part 12 has a second radius of curvature R _p less than the first radius of curvature R _c . This second radius of curvature R _p is chosen to conform the rear face of the peripheral part to the curvature of the dental arch portions extending between the canines and the molars of the patient. The fact that the rear faces of the central and peripheral parts 11, 12 have different radii of curvature R _c , R _p (with R _c > R _p ) allows the endpiece to have a shape that is particularly complementary to the shape of the buccal vestibule in which the tip is intended to be housed, which makes it possible to limit the risks of leakage while guaranteeing acceptable comfort for the patient.

Preferably, the distance between the free ends of the fins is between 40 and 80 millimeters, preferably between 50 and 70 millimeters, and even more preferably between 55 and 65 millimeters, in particular substantially equal to 60 millimeters. This makes it easier to insert the device into the mouth of a patient with a limited mouth opening while guaranteeing the tip a curvature allowing it to conform to the oral morphology of the patient.

Just as for the central part, the rear face 15 of the peripheral part 12 is smooth to allow insertion of the intraoral device in the mouth of a patient whose mouth opening is non-existent.

Tubular element

The tubular element 2 makes it possible to connect the intraoral device to an oxygen source (not shown).

The tubular element 2 comprises:

a proximal end 21 fixed in the end piece at the level of the through opening 13 of the central part 11,
a distal end 22 projecting from the front face of the tip,
a hollow pipe 23 to allow the circulation of a gas between the proximal and distal ends 21, 22.

The tubular element 2 can be removable. In this case, the tubular element 2 can be secured to the end piece by shape cooperation, for example by force-fitting the proximal end 21 into the through opening 13.

As a variant, the tubular element 2 can be irremovably fixed to the end piece 1. For example in the embodiment illustrated in , the proximal end 21 of the tubular element 2 comprises a substantially planar base intended to be embedded in the mass of the endpiece 1 during the molding of the intraoral device.

The distal end 22 of the tubular element comprises connection means configured to be connected to oxygen delivery means (not shown).

Since such a tubular element is known to those skilled in the art, it will not be described in more detail below.

Findings

The invention described above makes it possible to have an intraoral device that can be inserted into the mouth of a patient suffering from trismus and having a limited or even non-existent mouth opening.

The presence of two radii of curvature R _c , R _p allows:

facilitate the insertion of the intraoral device,
to limit the risk of gas leaks, and
improve patient comfort thanks to a better conformation to the buccal vestibule in which it is intended to be housed.

Of course, different sizes can be provided for the intraoral device in order to adapt to the morphology of the patients (child/adult, small/large size, etc.).

In addition, for certain applications (pediatric applications for example), the material constituting the tip can be flavored in order to limit the risks of rejection of the intraoral device by the patient.

Claims

A device configured to be inserted into the oral cavity of a patient, the device comprising:

a mouthpiece (1) configured to be inserted into the vestibule of the oral cavity, the mouthpiece (1) including an oval and curved body having:

a central part (11) having a through opening (13), the central part (11) having:

a central front face (14) adapted to extend opposite the patient's lips, and

a central rear face (15) adapted to extend facing the patient's teeth, and

a peripheral part (12) composed of a pair of fins each extending over a respective side edge of the central part (11), the peripheral part (12) having:

a peripheral front face (14) adapted to extend opposite the inner faces of the patient's cheeks, and

a peripheral rear face (15) adapted to extend facing the patient's teeth,

a tubular element (2) having proximal (21) and distal (22) ends, the proximal end (21) being fixed in the through opening (13) of the central part (11) and the distal end (12 ) projecting from the front face (14),

the central rear face (15) having a first radius of curvature (R c ) and the peripheral rear face (15) has a second peripheral radius of curvature (R p ), the first radius of curvature (R c ) being greater than the second radius of curvature (R p ),
characterized in that the central and peripheral rear faces (15) are smooth.
Device according to Claim 1, in which the central front face (14) comprises upper and lower grooves (17) extending in a direction going from one of the peripheral fins to the other of the peripheral fins, the groove (17 ) upper being configured to receive the patient's upper lip, and the lower groove (17) being configured to receive the patient's lower lip.
Device according to any one of Claims 1 or 2, in which each fin joins a respective lateral edge of the central part (11) at the level of a respective ridge (18), the distance between the ridges (18) being between 30 and 60 millimeters, preferably between 40 and 50 millimeters.
Device according to any one of Claims 1 to 3, in which the distance (L) between the fins of the peripheral part (12) is between 40 and 80 millimeters, preferably between 50 and 70 millimeters, and even more preferably between 55 and 65 millimeters, in particular substantially equal to 60 millimeters.
Device according to any one of Claims 1 to 4, in which the height (H) of the central and peripheral parts (11, 12) is between 15 and 25 millimetres.
Device according to any one of Claims 1 to 5, in which the tubular element (2) extends along a longitudinal axis A-A', the distance (P) between the free end (16) of each fin and the point of the central part (11) closest to the distal end (22) of the tubular element (2) being between 40 and 60 millimeters, preferably between 45 and 55 millimeters, and even more preferably between 48 and 50 millimeters, in particular substantially equal to 49 millimeters.
Device according to any one of claims 1 to 6, in which the thickness of each fin is between 1 and 10 millimeters, preferably between 2 and 6 millimeters, and even more preferably between 3 and 5 millimeters, in particular substantially equal at 4 millimeters.
Device according to any one of Claims 1 to 7, in which the central and peripheral parts (11, 12) are made of a material having a Shore hardness of between 10 and 70 Shore A, preferably between 20 and 60 Shore A, and even more preferably between 30 and 50 Shore A.
Device according to one of Claims 1 to 8, in which the central front face is curved so that the said central front face is shaped along first and second curvatures corresponding to first and second directions orthogonal to each other and perpendicular to the longitudinal axis A-A'.