WEIGHTED REHABILITATION PACIFIER

Abstract

TITLE OF THE INVENTION: WEIGHTED REHABILITATION PACIFIER An orthopedic pacifier (200) for children, comprising: a pacifier body (232), a teat cup (230) attached to the pacifier body, and a weight (235) removably attached to the pacifier body. Figure for the abstract: Figure 4

Description

Title of the invention: WEIGHTED REHABILITATION PACIFIER Technical field of the invention

[0001] The present invention relates to a weighted functional rehabilitation pacifier. It is applicable to tongue rehabilitation and the stimulation of maxilla and mandible growth, particularly in young children and infants. Prior art

[0002] Currently, in cases of moderate airway obstruction, restoring respiratory mechanics can be achieved by adapting sleeping posture. This involves avoiding the supine position, which induces a backward displacement of the mandible and the base of the tongue due to gravity, as well as physiological relaxation of the airway dilator muscles, thus increasing the risk of respiratory obstruction. Studies also tend to demonstrate that the prone position (lying on the stomach), with the patient upright, helps to stiffen the pharynx and therefore reduce the risk of airway obstruction. However, this action proves insufficient in some cases.

[0003] In particular, in children over six years of age, Obstructive Sleep Apnea / Hypopnea Syndrome (OSAS) can be treated through orthopedic intervention. This involves correcting the craniofacial anomaly by performing rapid palatal expansion and / or nocturnal mandibular advancement. Due to their anatomical connections, mandibular advancement allows the tongue to be freed from the pharynx and increases the dimensions and patency of the upper airway (UA). The most frequently considered solution in the most severe cases is surgery such as mandibular osteodistraction. However, this solution requires invasive treatment.

[0004] Some authors have also proposed applying traction by attaching the mandible to a mass. However, there is no device that allows, easily and without invasive action, the stimulation of maxillary and mandibular growth in children. Description of the invention

[0005] The present invention aims to remedy all or part of these drawbacks.

[0006] To this end, the present invention relates to an orthopedic pacifier for children, which comprises: - a pacifier body, - a teat cup attached to the teat body and - a weight that is removablely attached to the body of the teat.

[0007] Thanks to these provisions, the weight of the weighted pacifier can be adjusted as needed, particularly in the context of tongue rehabilitation or in the context of promoting the growth of the maxilla and mandible, especially in young children and infants.

[0008] The weighted pacifier of the invention allows forces to be applied to the upper jaw and / or the mandible of the child and these forces to be adjusted by varying the weight of the ballast.

[0009] Indeed, one of the aims of the invention is to provide a device for the treatment and / or relief of obstructive sleep-disordered breathing. For example, the pacifier that is the subject of the invention is useful in the context of non-invasive and early management of Obstructive Sleep-Related Breathing Disorders (abbreviated "OSBRD") such as Obstructive Sleep Apnea / Hypopnea Syndromes (abbreviated "OSAHS"), associated with a craniofacial anomaly of the mandibular hypoplasia type.

[0010] In particular, the pacifier of the invention can be used in combination with a cushion or chair that allows the child to be positioned in a forward-leaning position. In this position, the child's face is directed downwards and forwards. In this position, the lower edge of the mandible is close to vertical. Thus, the pacifier pulls the jaw(s) downwards, or forwards, towards the face.

[0011] Furthermore, to compensate for the increased weight of the pacifier, the child, in order to keep it in their mouth, will contract the muscles of the tongue and lips and contract the muscles that raise the mandible. Consequently, a pulling force is exerted on the child's jaws, promoting their forward development and toning the muscles of the tongue, lips, and mandible. These muscles contribute to the growth of the jaws, and therefore to anatomical development.

[0012] It is emphasized that the proper functioning of the perioral muscles and the smooth operation of oral functions enable the harmonious maxillomandibular development of the child. It is also emphasized that the growth rate, expressed in cm / year, is highest at birth and then gradually declines. Thus, the earlier the treatment, the faster it will be effective.

[0013] The pacifier that is the subject of the invention is particularly suitable for monitoring newborns, infants, and very young children up to three years of age. However, it can be adapted to suit older children without departing from the scope of the invention.

[0014] In embodiments, the length ratio between the thickest part and the thinnest part of the teat measured on any vertical cross-section of the teat is between 1 and 5. In other embodiments, this ratio is between 1 and 3.

[0015] In other words, the teat, along any vertical cutting plane, presents a profile substantially uniform, that is to say without significant bulging.

[0016] These features significantly distinguish the invention from known prior art devices which, on the contrary, have a bulge configured to facilitate effortless holding of the pacifier in the child's mouth.

[0017] The absence of excessive swelling contributes to increasing the necessary contraction efforts of the tongue, lip and mandibular elevator muscles that the child must produce to keep the pacifier in the mouth.

[0018] For the purposes of the invention, the vertical plane of the pacifier is the plane corresponding to the median sagittal cutting plane of the child's head, when the pacifier is positioned in the child's mouth, during normal use.

[0019] In embodiments, at least one dimension of the teat cup along a horizontal cross-sectional plane of the teat is complementary to at least one dimension of the developing dental arch of the child wearing the teat.

[0020] Thanks to these arrangements, the surface area of ​​the teat is increased, offering a better grip to the child who presses the teat against his palate while exerting pressure with his tongue.

[0021] In embodiments, the teat has a plurality of attachment points between the weight and the teat body.

[0022] Thanks to these arrangements, the ballast can be fixed in several places, depending on the needs or several ballasts can be fixed at the same time to vary the weight of the teat.

[0023] In embodiments, at least one attachment point is eccentric with respect to the center of gravity of the teat body.

[0024] Thanks to these arrangements, the weight fixed at a point away from the center of gravity of the pacifier body varies the orientation of the force exerted on the child's maxillomandibular complex by the weight of the pacifier. The weight can thus be oriented, according to needs, more to the right or to the left, for example.

[0025] In embodiments, the teat includes at least one sensor configured to estimate the elongation or compression of the teat cup.

[0026] Thanks to these provisions, the child's interactions with the teat can be measured as part of functional rehabilitation monitoring or more generally as part of monitoring the child. For example, the compression of the teat between the child's tongue and palate is measured.

[0027] In some embodiments, the pacifier includes a vibrator.

[0028] Thanks to these arrangements, the pacifier can emit a vibration according to a predetermined program or when no muscular activity is detected for a certain period of time or upon a command issued by a communicating portable terminal. The vibration felt by the child has the effect of stimulating the activation of the perioral muscles, for rehabilitation purposes.

[0029] In embodiments, the pacifier includes at least one sensor for estimating the activity of the lingual muscles or a sensor for the activity of the labial muscles.

[0030] Thanks to these provisions, the activity of the child's lingual and / or labial muscles can be estimated to facilitate monitoring the development of the child's maxillomandibular complex.

[0031] In embodiments, the pacifier includes at least one sensor for estimating pacifier movements.

[0032] Thanks to these arrangements, the movements of the pacifier resulting from the global activation of the perioral muscles can be tracked and quantified.

[0033] In embodiments, the activation of the vibrator is controlled according to the estimation of the activity of the lingual muscles or the labial muscles or according to the movements of the teat.

[0034] Thanks to these features, the vibrator can be activated based on the detection of predetermined muscle activity in the child. For example, a vibration can be emitted when no tongue muscle activity has been detected for a specified period of time. This vibration has the effect of stimulating the perioral muscles again. The resumption of muscle contractions by the child also makes it easier for the child to keep the pacifier in their mouth, as they again grip the teat between their tongue and palate.

[0035] In embodiments, the pacifier which has a collar having a notch constraining the orientation of the notched side of the collar towards the child's nose.

[0036] Thanks to these arrangements, the pacifier is always oriented in the same way in the child's mouth.

[0037] In embodiments, the pacifier includes anchoring means connecting the pacifier to the child's head and said anchoring means are configured to leave a gap, of a length less than or equal to the length of the teat cup, between the child's lips and the body of the pacifier.

[0038] Thanks to these provisions, the anchoring means make it possible on the one hand to prevent the child from completely losing the pacifier and on the other hand to prevent the anchoring means from replacing the muscular efforts that we want the child to produce in order to keep the pacifier in the mouth. Brief description of the figures

[0039] Other advantages, purposes and particular features of the invention will become apparent from the following non-limiting description of at least one particular embodiment of the pacifier that is the subject of the present invention, with reference to the accompanying drawings, in which:

[0040] [Fig. 1] schematically represents a first particular embodiment of the pacifier that is the subject of the present invention, positioned on a child's face, in front view,

[0041] [Fig.2] schematically represents the first particular embodiment of the pacifier that is the subject of the present invention, in side section view,

[0042] [Fig.3] schematically represents a second particular embodiment of the pacifier that is the subject of the present invention, positioned on the face of a child, shown in a horizontal section,

[0043] [Fig.4] schematically represents the second particular embodiment of the pacifier that is the subject of the present invention, in vertical section view and

[0044] [Fig.5] represents, schematically, a particular embodiment of a system which includes a pacifier which is the subject of the invention. Description of the implementation methods

[0045] The present description is given by way of non-limiting grammar, each feature of an embodiment being able to be advantageously combined with any other feature of any other embodiment.

[0046] It should be noted from the outset that the figures are not to scale.

[0047] Figure [1], which is not to scale, shows a schematic view of a mode of a particular embodiment of the 300 teat, the subject of the present invention. A schematic cross-sectional view of the 300 teat is shown in [Fig. 2], which is not to scale.

[0048] The teat 300 comprises a teat 30 which, in normal use, is positioned in the mouth of a child 11 and a collar 31 which is positioned outside the mouth against the lips of the child 11.

[0049] The teat 30 is integral with a teat body 32. A weight 35 is removably attached to the teat body 32. For example, the weight 35 is a weighted tip weighing between 10 and 300 grams, preferably between 20 and 100 grams. For example, the weight 35 is a small weight. In some embodiments, several weights are used and can be added together to achieve the desired weight.

[0050] A fastening means 36 allows the weight 35 to be fixed to the body 32. For example, the fastening means 36 is a clip-type fastening system, complementary to a fastening system integral with the weight 35. For example, the fastening means 36 is a bayonet-type fastening or a Velcro-type fastening (registered trademark).

[0051] In embodiments (not shown), the teat 300 has a plurality of attachment points between the weight 35 and the teat body 32.

[0052] In embodiments (not shown), the teat 300 has at least one attachment point eccentric with respect to the center of gravity of the teat body.

[0053] In embodiments, the teat 300 includes a vibrator 95 and a control means that controls the activation of the vibrator 95. For example, the vibrator 95 is an eccentric mass driven in rotation by an electric micromotor and the control means is a microprocessor 91. In embodiments, the strength and frequency of the vibrations of the vibrator 95 are controlled remotely by a communicating handheld terminal, based on the estimation of muscle activity or independently of the estimation of muscle activity.

[0054] Preferably, the vibrator 95 is positioned on the teat 30.

[0055] In embodiments, the teat 300 includes at least one sensor, 76, 78, 82, 85 or 87.

[0056] In some embodiments, the teat 300 includes a collar 31.

[0057] In embodiments, the teat 300 includes a sensor for estimating the activity of the lingual muscles or a sensor for estimating the activity of the labial muscles.

[0058] For example, the sensor for estimating the activity of the lingual muscles includes a pair of electrodes 76 placed on the teat 30, in contact with the child's tongue, during normal use of the teat 300. In other embodiments, the sensor for estimating the activity of the lingual muscles includes a pressure sensor placed on the teat 30.

[0059] For example, at least one lip muscle activity estimation sensor includes a pair of electrodes 78 placed on the collar 31, in contact with the child's lips, during normal use of the pacifier 300. In other embodiments, the lip muscle activity estimation sensor includes a pressure sensor.

[0060] In embodiments, the pacifier 300 includes a sensor 82 for estimating the presence or absence of the pacifier in the child's mouth.

[0061] In some embodiments, the teat 300 includes a sensor 87 configured to estimate the elongation of the teat. For example, the sensor 87 is an optical or electrical extensometer, or one that measures the deformation of an extensible material.

[0062] In some embodiments, the teat 300 includes a sensor 85 configured to estimate the compression force applied to the teat. For example, the sensor 85 is a compression force sensor.

[0063] In some embodiments, the teat 300 also includes at least one sensor for estimating the movements of the teat 300 to identify activation of the perioral muscles. This may be an accelerometer integrated into the collar 31.

[0064] In some embodiments, the teat 300 includes a memory 92 configured to store at least some of the measured data or any other information useful for the operation of the teat 300. The memory can also be located on a local or remote server.

[0065] In some embodiments, the pacifier 300 includes a means for transmitting a signal representative of a physiological quantity of the child, for example, a data transmission cable. Preferably, the means for transmitting a signal representative of a physiological quantity of the child is a wireless transmitter. For example, the wireless transmitter is an antenna 94 configured to transmit a signal representative of a quantity estimated by one of the sensors of the pacifier 300 or to transmit a signal representative of information relating to the pacifier 300, for example, its battery level. Preferably, the wireless transmitter is a transceiver also configured to receive a signal representative of a command in order to transfer it to the microprocessor 91 or to another electronic component of the pacifier 300.

[0066] In some embodiments, the wireless transmitter is an antenna 94 operating according to the IEEE 802.11 "Wi-Fi" standard or configured to transmit or receive information using Bluetooth technology (registered trademark) or a radio-frequency identification (RFID) communication protocol. Preferably, the antenna 94 exchanges information with a Wi-Fi network or with a smart portable terminal.

[0067] Wi-Fi, Bluetooth and RFID antennas are extensively detailed both in the prior art and in reference works in the field, so their implementation or operation details are not repeated here.

[0068] In some embodiments, the pacifier 300 further comprises a power supply 93, for example a battery. In other embodiments, the power supply 93 is a rechargeable battery. In other embodiments, the pacifier 300 is connected to an external power supply by an electrical cable.

[0069] In some embodiments, the pacifier 300 includes anchoring means that constrain the position of the pacifier 300 in the child's mouth 11. The anchoring means that constrain the position of the pacifier in the child's mouth include, for example: - a notch 25 cut into the collar 31, constraining the positioning of the notched side of the collar 31 towards the nose 14 of the child 11, and - two cords, 20 and 21, fixed on either side of the collar 31 and each forming a loop configured to be passed around an earlobe, respectively 12 and 13, of the child 11.

[0070] In embodiments (not shown), the pacifier 300 includes anchoring means connecting the pacifier to the child's head 11, and the anchoring means are configured to allow a slack of length less than or equal to the length of the teat 30, between the child's lips and the body 32 of the teat 300. Thus, the anchoring means retain the teat 300 when the child 11 drops it by opening their mouth and keep it at a distance short enough for the child to be able to take hold of the teat 300 with their mouth.

[0071] In embodiments (not shown), the collar 31 has a notch of adjustable size to the dimensions of the child's nose 14.

[0072] In embodiments, at least one cord, 20 or 21, comprises an elastic material allowing for a better fit around the ear, 12 or 13.

[0073] Figure 3, which is not to scale, shows a schematic view of a particular embodiment of the pacifier 200, the subject of the present invention. The pacifier 200 is shown in a top view, in the mouth of a child whose lower lip 18 and developing dental arch 15 are also shown.

[0074] We observe in [Fig.4], which is not to scale, a schematic cross-sectional view of the pacifier 200, in position in the mouth of a child 11. The cross-sectional plane represented in [Fig.4] corresponds to a median sagittal plane of the skull of the child 11, perpendicular to that of the previous figure.

[0075] The teat 200 comprises a teat cup 230. A collar 231 is positioned outside the mouth and comes against the child's lips 18 to prevent the risk of swallowing the teat 200. The teat cup 230 is integral with a teat body 232. A weight 235 is removably attached to the teat body 232.

[0076] In [Fig. 4], the child 11 is shown in a forward-leaning posture, with their head oriented forward and towards the ground. The force of gravity G tends to cause the pacifier 200 to fall towards the ground. The child 11 grips the pacifier using their lingual and labial muscles and the elevator muscles of the mandible, and in particular by compressing the teat 230 between their tongue 16 and palate 17.

[0077] The sucking force, resulting from the pressure of the tongue 16 against the palate 17 and the pressure of the lips 18 on the narrow part of the teat 200, as well as the contraction of the mandibular elevator muscles, will keep the teat 200 in the child's mouth. The weight of the teat will thus exert a forward and / or downward force on all the perioral anatomical structures, and in particular the jaws.

[0078] Observed according to a horizontal section plane, as illustrated in [Fig.3], the teat 230 has an isthmus 237, that is to say an elongated part of smaller dimension, at the passage of the lips 18 and a part 238 flared to occupy the space formed between the palate 17 and the tongue 16.

[0079] Preferably, the surface area of ​​part 238 of the teat 230 is greater than or equal to two-thirds of the surface area of ​​the palate 17.

[0080] Preferably, at least one dimension of the teat 230, according to the horizontal cross-sectional plane of the teat, is complementary to a dimension of the dental arch in formation 15 or of the palate 17 of the child 11 wearing the pacifier.

[0081] In embodiments, part 238 of the teat has a general shape of a solid and concave "U", the concave face of which is oriented towards the tongue 16 and the convex face is oriented towards the palate 17.

[0082] It is clear from [Fig. 4] that the teat 230, viewed along a vertical cross-section, is quite thin. The profile of the teat is preferentially thin, uniform, and does not have any bulges.

[0083] For the purposes of the invention, the vertical plane of the pacifier 200 is the plane corresponding to the median sagittal cutting plane of the head of the child 11, when the pacifier 200 is positioned in the mouth of the child 11, during normal use.

[0084] In embodiments, the length ratio between the thickest part and the thinnest part of the teat 230 measured on any vertical cross-section of the teat 200 is between 1 and 5. In other embodiments, this length ratio is between 1 and 3.

[0085] Figure 5 shows a monitoring system 500 comprising at least one pacifier according to the invention. The system 500 includes a wireless transmitter configured to emit a signal representative of a physiological quantity of the child or to emit a signal representative of a quantity related to the functioning of the pacifier 300.

[0086] The pacifier 300 is configured to send the signal to a communicating portable terminal, for example a tablet 51 or a smartphone 52. The communicating portable terminal, 51 or 52, includes a display means.

[0087] The pacifier 300 and / or the communicating portable terminal, 51 or 52, include means for issuing an alert when the physiological variable or the variable related to the functioning of the pacifier 300 received exceeds a predetermined threshold. In embodiments, upon an alert, the pacifier 300 and / or the communicating portable terminal, 51 or 52, emit a visual, audible, or silent alarm, or display a predetermined physiological data point on the display means.

[0088] For example, the alarm takes the form of a ring emitted by the communicating portable terminal, 51 or 52, a vibration, a notification or a written message simply displayed or transmitted by a messaging service.

[0089] In some embodiments, the portable communicating terminal, 51 or 52, includes means for controlling a vibrator positioned on the nipple 300.

[0090] Estimates of the child's physiological measurements are recorded locally at the level of the pacifier's memory 300 or accessible at the level of a memory of the communicating portable terminal, 51 or 52, connected by a wireless communication protocol, for example Bluetooth or Wi-Fi (trademarks).

[0091] In some embodiments, these same recordings can be copied to a remote computer server 55, connected to the portable terminal com communicating via a wired connection or via a data network such as the internet or a cellular network.

[0092] The remote server 55 includes means for receiving the signal representing a physiological quantity of the child. In some embodiments, the remote server includes means for issuing an alert when the signal representing a physiological quantity exceeds a predetermined threshold.

[0093] In some embodiments, the system 500 includes a terminal 57 accessible to a healthcare professional connected to a remote computer server 55, or to the communicating portable terminal 51 or 52, via a wired connection or via a data network such as the internet or a cellular network. Preferably, the terminal 57 includes a means for receiving the alert issued by the remote server 55.

Claims

Claims

1. Orthopedic pacifier (200, 300) for a child (11), characterized in that it comprises: - a pacifier body (32, 232), - a teat (30, 230) secured to the pacifier body and - at least one means (36) for fixing a weight to the pacifier body and - at least two weights (35, 235) of different weights, one weight (35, 235) among the at least two weights being removably fixed to the pacifier body.

2. A teat according to claim 1, wherein the length ratio between the thickest part and the thinnest part of the teat measured on any vertical sectional plane of the teat is between 1 and 5.

3. A pacifier according to claim 1 or 2, wherein at least one dimension of the pacifier along a horizontal sectional plane of the pacifier is complementary to a dimension of the developing dental arch of the child wearing the pacifier.

4. A teat according to any one of claims 1 to 3, which comprises a plurality of attachment points between the weight and the teat body.

5. A pacifier according to claim 4, wherein at least one attachment point is eccentric relative to the center of gravity of the pacifier body.

6. A teat according to one of claims 1 to 5, which comprises at least one sensor (87) configured to estimate the elongation or compression of the teat.

7. A pacifier according to one of claims 1 to 6 which comprises a vibrator (95).

8. Pacifier according to one of claims 1 to 7, which comprises at least one sensor (76) for estimating the activity of the lingual muscles or a sensor (78) for the activity of the labial muscles.

9. Pacifier according to one of claims 1 to 8, which comprises at least one sensor for estimating the movements of the pacifier.

10. A pacifier according to claim 8 or 9, when dependent on claim 7, wherein activation of the vibrator is controlled based on estimation of lingual muscle or labial muscle activity or based on pacifier movements.

11. A teat according to one of claims 1 to 10, which comprises a collar (31, 231) comprising a notch (25) constraining the orientation of the the notched side of the collar towards the child's nose.

12. A pacifier according to one of claims 1 to 11, which comprises anchoring means connecting the pacifier to the child's head and in which the anchoring means are configured to leave a gap, of a length less than or equal to the length of the teat, between the child's lips and the body of the pacifier.

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