USE THEREOF

Technical field

The present invention relates to the field of a wearable system for the delivery of a treatment through the nose of a subject, more particularly to a therapeutic system comprising a thermoplastic nose mask adaptor, a device provided at an end with a coupling suitable to be connected to one or more tubes for delivery of the treatment through the nose and at least one fixation means. I n particular, it concerns a system that can be worn for the treatment of respiratory distress and sleep apnea.

The present invention also relates to a kit for delivery of a treatment through the nose of a subject and to a use thereof.

Background

Many people experience breathing problems on a recurring basis, which often results in sleep disordered breathing (i.e., difficulty sleeping, snoring, or other more serious conditions such as obstructive sleep apnea) . As technology advances, people with such breathing problems demand increased performance and comfort.

Previous devices for improving a user's breathing have included custom fitted masks that help deliver air or another suitable gas to the user's nose at positive pressure to help force open the user's breathing passage and thus improve the user's breathing. However, previous masks are relatively expensive due to the expertise often required to design, manufacture, and fit the masks to each particular user. Furthermore, previous masks have often been fitted to the user's unique bone structure and facial features rather poorly, if at all. As a result, previous masks have often failed to adequately prevent leakage from around the perimeter of the mask, caused discomfort for users, and have been relatively ineffective in treating breathing problems such as sleep disordered breathing.

A variety of supports are known in the art that may be worn by a subject and which secure a tube for the delivery of a treatment (e.g. a liquid, a gas) through the nose.

US 2006/0005837 discloses a custom fitted mask configured for coupling to an external gas supply system . The mask comprises a first sheet of deformable material that has been deformed against a user's face surrounding the user's nostrils while the first sheet is in a deformable state to conform substantially optimally to the user's unique facial features. The mask further comprises a fitting adapted for coupling to the external gas supply system ; and a second sheet of deformable material configured around the fitting. The second sheet is applied against the fitting while the second sheet is in a deformable state such that the fitting is positioned between the first and second sheets, a contact portion of the second sheet conforming substantially optimally to a contact portion of the first sheet and being bonded to the contact portion of the first sheet. A drawback of this system is that it comprises two sheets that have to be deformed. A custom fitted mask according to US’837 requires a substantial amount of deformable material and multiple deformation steps.

US 2004/0079374 discloses a custom fitted mask, comprising a first thin sheet of deformable material that has been formed and fitted to a first portion of a user's face surrounding the user's nostrils. The mask comprises fittings that have been inserted for coupling the mask to an external gas supply system. I n these masks, the fitting is permanently fixed to the mask. This is disadvantageous as the mask has to be discarded as soon as the fitting is damaged (after a multiple use and/or a misuse for instance).

Another type of masks is described in WO 2010/125074. Said mask is a heat moldable nose mask, having a longitudinal direction, formed from a sheet of thermoplastic material configured for individual molding across at least part of the cheek bones of the subject. The mask comprises a nose aperture dimensioned to fit the nose of the subject, and a fixture for a strap at each opposing longitudinal end of the mask. These types of masks are also prone to dislodging especially when the wearer is sleeping. Moreover, the mask covers a large surface of the face thereby providing the wearer with a low level of comfort.

Nasal masks are particularly being useful in assisting patients with under-developed lungs, in particular, infants and especially premature infants or neonates, by preventing lung collapse during exhalation and assisting lung expansion during inhalation. For neonates, common supports are: binasal prongs, nasal cap mask, or an endotracheal tube. Binasal prongs have been associated with necrosis of the nasal septum when the prongs are not placed properly in the nares. After 1 or 2 weeks, the nostril often distend. Other forms of nasal erosion resulting from the prongs or facemask are potential risks. Nasal cap masks, which are triangular in shape to compliment the nose, and seal against the skin of the subject, are described for instance, in US 2006/0096598. A disadvantage of such masks is the weight and the low level of comfort they afford the wearer. Because they seal using a triangular facial component, pressure is applied to the skin in a concentrated

5 region along the triangle edges. They result in unseemly pressure marks to the skin of the wearer after use. Even then, they often fail to prevent leakage. Such masks may be worn only for limited period of time without the risk of adverse reaction.

WO 2013/006913 discloses a textile mask system for providing pressurized0 breathable gas. The system includes at least one panel and a seal member, wherein the panel comprises a textile. The panel defines a cavity adapted to receive a patient’s nose. The seal member is adapted to sealingly engage with the patient’s face. The panel and seal member may be integrally formed in one piece. A disadvantage of this kind of mask is that the sealing member is flexible and has a5 self-sealing action when a positive air pressure is applied within the mask. This means that the sealing member is pressed and stretched against the face of the wearer, resulting in pressure marks to the skin of the wearer after use. An additional problem is that the textile mask does not necessarily have sufficient structural stability to prevent distortion of the mask, resulting in dislodging of the mask or in0 leakages. It can be required to add rigidizing structures for preventing distortion and to avoid leakages, especially in portions extending between the wearer’s nasal bridge and cheeks. This increases the complexity of the textile mask. The textile mask can also be in contact with the face of the wearer, what can result in friction marks on the skin. 5

The aim of the present invention is to provide a solution to overcome at least part of the above mentioned disadvantages.

Sum m ary of the invention 0

According to the present invention, problems and disadvantages associated with previous masks and methods for forming them are reduced or eliminated.

I n a first aspect, the present invention relates to a system comprised of a nose mask5 adaptor formed of a sheet of thermoplastic material, a device configured to fit around an aperture comprised within the sheet and at least one fixation means configured to fixate the device on the nose mask adaptor. The system is beneficial for delivery of a treatment through the nose of a subject in a comfortable, performant and secure manner, while only a limited amount of thermoplastic material and steps are required for forming the nose mask adaptor. The sheet of thermoplastic material allows to obtain via thermoforming a nose mask adaptor with a shape substantially corresponding to the subject’s face, especially on and around

5 the nose. The nose mask adaptor is personalized and therefore guarantees a high degree of comfort for the subject. The subject’s nose extends through the aperture within the sheet. The device fits around the aperture and covers the aperture. The device is provided at an end with at least one coupling suitable to be connected to one or more tubes for delivery of a treatment through the nose. The fixation means0 allows to fixate the device to the nose mask adaptor. This avoids that the device has to be placed directly on the subject’s face, improving the comfort of the subject, and also assures that the device is secured in place. Because the device is fixated on the nose mask adaptor and the nose mask adaptor fits tightly on the subject’s face and nose, leakage is minimal, resulting in an improved performance of the5 system compared to the prior art.

Because the nose mask adaptor is rigid after cooling down, the nose mask adaptor is structural stable to avoid dislodging or leakages. No further rigidizing structures are required, resulting in a simple wearable system. 0

Especially beneficial is a system according to claim 2. The aperture comprises a slit, whereby the slit delimits two flanking flaps. The presence of flaps on the lateral sides of the nose provides more stability to the nose mask adaptor thereby reducing the chances of being dislodged. Moreover, the surface of the face covered by the5 nose mask adaptor can be reduced as the flaps provide good stability to the nose mask adaptor which provides more comfort to the wearer.

Another advantageous embodiment is a system according to claim 8. The device is dismountably fixed to the nose mask adaptor. This allows a better cleaning of the0 device and/or the nose mask adaptor thereby insuring high level of hygiene to the wearer. Furthermore, in case of damage, only the damaged part, the device and/or the nose mask adaptor, needs to be replaced by a new one.

I n a second aspect, the present invention provides a kit for delivery of a treatment5 through the nose of a subject comprising: a sheet of thermoplastic material as described above suitable for forming a nose mask adaptor, a device as described above, a fixation means as described above and at least one pressurizing means for applying a pressure on the sheet of thermoplastic material during the molding process. The big advantage of the kit is that with a limited amount of thermoplastic materials and deform ing steps, a wearable system for delivery of treatment through the nose of a subject in a comfortable, performant and secure manner can be obtained. The pressurizing means ensure a good molding of the thermoplastic sheet and thereby an optim ized fitting of the nose mask adaptor.

I n a third aspect, the present invention provides for the use of a kit according to the invention for molding a nose mask adaptor directly on a subject’s nose for delivery of a treatment through the nose of said subject. This use is beneficial because the kit is adapted for forming a wearable system for delivery of treatment through the nose of a subject in a comfortable, performant and secure manner, while only a limited amount of thermoplastic materials and deform ing steps are required.

Description of figures

FI G. 1 shows a sheet of heat moldable thermoplastic material according to the present invention. The sheet is in a non-molded state.

FI G. 2 shows a nose mask adaptor according to the present invention. The nose mask adaptor is obtained by molding the sheet of heat moldable thermoplastic material shown in FI G. 1 on a subject’s nose.

FI G. 3 shows an embodiment of a wearable system according the current invention, by fixating the device shown in FI G. 4a on the nose mask adaptor shown in FI G.

2.

FI G. 4a shows a device configured to fit around the aperture of the nose mask adaptor.

FI G. 4b shows a cross section view according to A-A of the device shown in Fig. 4a.

FI G. 5a is a perspective view of the nose mask adaptor of FI G. 2 on a subject’s face.

FI G. 5b is a perspective view of a wearable system according to an embodiment of the current invention on a subject’s face, comprising the nose mask adaptor of FI G. 5a and the device of FI G. 4a. FI G. 6 shows an alternative of a sheet of heat moldable thermoplastic material according to the present invention, comprising a second aperture for the subject’s mouth. The sheet is in a non-molded state.

5

FI G. 7 is a perspective view of a nose mask adaptor formed of the sheet of FI G. 6 on a subject’s face.

FI G. 8 is a perspective view of a wearable system according to an embodiment of0 the current invention on a subject’s face, comprising the nose mask adaptor of FI G. 7 and a device according to an embodiment of the current invention.

FI G. 9 shows an alternative of a sheet of heat moldable thermoplastic material according to the present invention, comprising a first part of a fixation means. The5 sheet is in a non-molded state.

FI G. 10 shows a nose mask adaptor according to the present invention. The nose mask adaptor is obtained by molding the sheet of heat moldable thermoplastic material shown in Fig. 9 on a subject’s nose. 0

FI G. 1 1 shows an embodiment of a wearable system according the current invention, by fixating an alternative embodiment of a device, comprising a second part of a fixation means, on an alternative embodiment of a nose mask adaptor, comprising a first part of a fixation means. 5

FI G. 12 shows a cross section view according to B-B of the wearable system shown in FI G. 1 1 .

Detailed description of the invention 0

Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions are included to better appreciate the teaching of the5 present invention.

As used herein, the following terms have the following meanings: “A”, “an”, and “the” as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, “a compartment” refers to one or more than one compartment.

5 “About” as used herein referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of + /- 20% or less, preferably + /-10% or less, more preferably + /- 5% or less, even more preferably + / -1 % or less, and still more preferably + / - 0.1 % or less of and from the specified value, in so far such variations are appropriate to perform in the disclosed0 invention. However, it is to be understood that the value to which the modifier “about” refers is itself also specifically disclosed.

“Comprise”, “comprising”, and “comprises” and “comprised of” as used herein are synonymous with “include”, “including”, “includes” or “contain”, “containing”,5 “contains” and are inclusive or open-ended terms that specifies the presence of what follows e.g. component and do not exclude or preclude the presence of additional, non-recited components, features, element, members, steps, known in the art or disclosed therein. 0 The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within that range, as well as the recited endpoints.

The expression “% by weight”, “weight percent”, “%wt” or “wt%”, here and throughout the description unless otherwise defined, refers to the relative weight of5 the respective component based on the overall weight of the formulation.

I n the context of this document a thermoplastic composition layer is a layer comprising a thermoplastic composition having two surfaces: an upper surface and a lower surface. 0

I n the context of this document a sheet of thermoplastic material is a sheet of material that is deformable under the application of heat and after cooling down retains the deformed shape and becomes rigid. 5 For the remainder of this document a support layer is a layer that comprises a different composition compared to a thermoplastic composition layer as defined above. With continuously bonding is meant in the context of this document that 100% of the surface area of one side of a layer is bonding on 100% of the surface area of one side of a thermoplastic composition layer.

By the term bonding by heat or “heat-bonded” is meant in the context of this document that a bonding reaction is caused by heat only, no additional adhesive or glue is required.

By the term breathable it is meant in the context of this document that air can pass through a fabric and/or a material. As used herein, the term "breathable" also refers to a material which is permeable to water vapor.

By the term breathable foam it is meant in the context of this document a foam through which air passage is possible.

By the term “elastic fabric” is meant in the context of this document a fabric comprising an elastic yarn or a combination of different elastic yarns.

I n a first aspect, the invention is related to a wearable system for delivery of a treatment through the nose of a subject.

I n a preferred embodiment, the wearable system comprises a nose mask adaptor, a device and at least one fixation means.

The nose mask adaptor is formed from a sheet of thermoplastic material, said sheet being initially substantially flat and configured to be moldable upon thermoforming directly onto a subject’s face, conform to the contours of the subject’s face, which after cooling down retains the deformed shape and becomes rigid or semi-rigid, whereby said sheet comprises an aperture dimensioned to fit the nose of the subject, said aperture is flanked by the two flaps which are designed to rest on and at least partially cover the lateral sides of the nose.

The aperture is dimensioned such that the nose substantially passes there through. It is of sufficient size that at least the nostrils pass entirely through the aperture, for instance, during molding. It is of sufficient size that at least the nasal tip passes entirely through the aperture, for instance, during molding. Preferably, the aperture of the nose mask adaptor is dimensioned such that the nose bridge, the nostrils and the nose tip pass entirely there through. The said sheet is advantageous to form a nose mask adaptor specific for a particular subject relatively quickly and easily, with little expertise required on the part of a clinical professional who is producing the nose mask adaptor, typically resulting in

5 improved efficiency for the clinical professional and reduced cost to the subject. The formed nose mask adaptor conforms substantially optimally to the subject’s unique facial features, more specifically of the nose, so providing a comfort fit enabling it to be worn for extended periods. 0 The device is configured to fit around the aperture of the nose mask adaptor and to rest on the nose mask adaptor, said device is suitable to cover the aperture of the nose mask adaptor and is provided at one end with an opening for receiving the nose and at the other end with at least one coupling suitable to be connected to one or more tubes for delivery of the treatment through the nose. 5

The opening for receiving the nose is proximal to the subject’s face and the coupling is distal to the subject’s face when the wearable system is worn by a subject. The device is not placed directly on the subject’s face, avoiding irritation of his skin and further improving his comfort. 0

The at least one fixation means is configured to fixate the said device on the nose mask adaptor.

Fixating the device on the nose mask adaptor assures that the device is secured in5 place, also when the subject is at sleep. Where the wearable system is used for delivery of pressurized air, for instance, in the treatment of sleep apnea, the individual fit also provides a partial sealing function, resulting in an improved performance of the system compared to the prior art. The wearable system is thanks to the nose mask adaptor particularly suitable for wearing at night without0 discomfort, and so may be utilized in the treatment of sleep apnea when the treatment delivered through the nose is air.

Because the nose mask adaptor is rigid after cooling down, the nose mask adaptor is structural stable to avoid dislodging or leakages. No further rigidizing structures5 are required, resulting in a simple wearable system . In an embodiment a skin contact or facing surface of the nose mask adaptor may be lined with a softened material such as a felt, neoprene, open or closed cell foam or knitted material.

5 The use of a softened material provides a pleasant feeling against the skin.

The use of a softened material allows a partial flow of circulating air across rather than through the device, thereby reducing the buildup of perspiration and heat below the wearable system . 0

In an embodiment said aperture of the said sheet has an substantially inverted T shape comprising a slit which extends to a lower opening, which opening is substantially extending perpendicular to the slit, whereby the slit delimits two flanking flaps. After thermoforming on a subject’s nose, said sheet extends across5 at least part of the cheek bones of the subject, whereby the nose bridge protrudes at least partially through said slit, the nose nostrils protrude at least partially through said lower opening; and each lateral side of the nose is at least partially covered by a flanking flap. 0 Preferably the dimensions of the base of the inverted T shape (BT) is 2 cm , 3 cm, 4 cm , 5 cm , 6 cm, 7 cm or 8 cm in length or a value in the range between any two of the aforementioned values. Preferably the height (HT) of the inverted T shape relative to the base is 2 cm, 3 cm , 4 cm, 5 cm , 6 cm, 7 cm or 8 cm in length or a value in the range between any two of the aforementioned values. 5

The above-mentioned dimensions are most preferably obtained when the mask is in the flattened condition, in other words measured on the sheet of heat moldable thermoplastic material. However, it will be appreciated that a curved mask can also be measured by transforming a digital model to a flattened state or by measuring0 along its surface.

The presence of flaps on the lateral sides of the nose provides more stability to the nose mask adaptor, thereby reducing the chances of being dislodged. Moreover, the surface of the face covered by the nose mask adaptor can be reduced as the flaps5 provide good stability to the nose mask adaptor which provides more comfort to the wearer. I n a preferred embodiment, the slit of the sheet of heat moldable thermoplastic material is also extending to an upper opening. The presence of said upper opening is optional. The upper opening is beneficial to fold the flanking flaps out of the plane of the said sheet, without risking ruptures or cracks.

5

I n a preferred embodiment, the length of the slit is such as at least part of the nose bridge is covered by the thermoformed sheet. I n this case, the flaps of the mask will be connected to each other by said thermoformed sheet covering part of the nose bridge. The length of the slit is of at least 1 mm , preferably at least 3 m m ,0 more preferably at least 5 mm , most preferably at least 10 mm , even most preferably at least 20 m m . The length of slit is at most 40 mm , preferably at most 30 mm , more preferably at most 25 m m , most preferably 20 mm . The length of the slit can be any value comprised in between the above mentioned values. 5 I n a preferred embodiment, the heat moldable thermoplastic material is initially partially thermoformed.

I n an embodiment the nose mask adaptor comprises fixtures for straps. The fixtures are provided at least at two different locations, one at the right cheek and one at0 the left cheek of a subject. The straps are configured to immobilize the wearable system on the subject’s nose. The fixtures and straps are beneficial to avoid that the wearable system has to be kept manually in place or to avoid that the wearable system has to be replaced regularly. 5 At each location the nose mask adaptor can comprise one, two, three, four or more fixtures, meaning that two, three, four or more fixtures can be provided at the right cheek and/or at the left cheek of a subject. Multiple fixtures at each location provide better stability when the wearable system is worn. 0 I n a further embodiment, the nose mask adaptor comprises at least one fixture for a strap which passes over the back of the head. This is advantageous for an even better im mobilization of the wearable system on the subject’s nose. Multiple fixtures for straps which pass over the back of the head provide better stability when the wearable system is worn. 5

I n an embodiment the fixtures for the strap are a single slot, or two or more slots, however, it is not necessarily lim ited thereto. The fixtures may comprise one part of a hook-and-loop fastener, or one part of a press-stud or snap-fastener, which attaches to a reciprocating element on the strap. The fixtures are adapted to affix a strap that secures the nose mask adaptor to the face of the subject.

I n an embodiment the wearable system comprises at least one strap. The strap is

5 preferably made from an elasticated substance, such as a strip of elasticated material, and may include a length adj uster, to adjust the length of the strap and thus pressure exerted by the nose mask adaptor on the face.

I n a preferred embodiment, the straps are attached to the wearable system in a0 configuration wherein at least part of the strap is surrounding at least partially the sheet of the nose mask adaptor, for instance when both parts of a hook and loop fastener, of a press-stud or of a snap-fastener are provided on the strap itself. Said strap is introduced in the fixture and both parts of the hook and loop fastener, the press-stud or the snap-fastener are fixed to each other. This is advantageous as the5 pressure applied on the wearer’s face is smaller compared to the pressure applied by a wearable system in which the straps are fixed on top and/or on the side of the wearable system which is not in contact with the wearer’s face. I n the latter case, the straps will push the wearable system on the wearer’s face which will be uncomfortable for said wearer. I n the configuration described in the frame of the0 present invention, the straps do not push the wearable system on the wearer’s face but will only secure the mask to wearer’s face.

I n a preferred embodiment, the straps are attached to the nose mask adaptor in a configuration wherein at least part of the strap is surrounding at least partially the5 nose mask adaptor sheet and wherein one part of a hook and loop fastener, of a press-stud or of a snap-fastener is provided on the strap itself while the other part is provided on the sheet of the nose mask adaptor.

I n a preferred embodiment the nose mask adaptor is dimensioned so as not to0 extend over the eyes or ears. The nose mask adaptor is devoid of apertures for the eyes or ears. A nose mask adaptor that does not extend over the eyes or ears is advantageous for subjects with claustrophobic fears.

I n an embodiment the nose mask adaptor is dimensioned so as to extend over the5 mouth of the subject. The nose mask adaptor has a second aperture for the mouth. This is beneficial for delivery of a treatment through the nose as well as through the mouth of a subject. This is especially beneficial for subjects who suffer from partially or fully blocked nostrils. The device is preferably configured to fit around the aperture of the nose and the second aperture of the mouth and to cover the aperture of the nose and the second aperture of the mouth.

I n a preferred embodiment, the form and/or the size of the flaps is variable. The

5 form of the flaps can be triangular, rectangular, conical or any other shape. The size of each flap covers at least 10% , preferably at least 20% , more preferably at least 30% , most preferably at least 40% , even most preferably at least 50% of the lateral side of the subject’s nose. 0 The size of each flap covers at most 100% , preferably at most 90% , more preferably at most 80% , most preferably at most 70% , even most preferably at most 60% of the lateral side of the subject’s nose.

The size of the flaps may also be sufficient to cover the full lateral side of the nose5 and to extend beyond said lateral side.

I n an embodiment the nose mask adaptor has a longitudinal length (L) and perpendicular thereto a width (W) . The aperture is preferably centrally located along the width of the nose mask adaptor. The aperture may also be centrally located with0 respect to the longitudinal length. The nose mask adaptor is configured for wearing such that the width (W) direction of the mask is oriented essentially parallel to the subject’s eye-line or his left-right axis.

The dimension of the longitudinal length (L) of the nose mask adaptor depends on5 the characteristics of the subject such as age, shape, and gender, but may be equal to or not more than 5 cm , 6 cm , 7 cm , 8 cm , 9 cm , 10 cm , 1 1 cm , 12 cm , 13 cm , 14 cm , 15 cm , 16 cm , 17 cm , 18 cm , 19 cm , 20 cm , 23 cm , 25 cm or a value in the range between any two of the aforementioned values, preferably between 10 and 18 cm . 0

The dimension of the width (W) of the nose mask adaptor may be defined as the distance between the opposing extrem ities of the nose mask adaptor. The dimension of width (W) will depend on the characteristics of the subject such as age, shape, and gender, but may be equal to or not more than 7 cm , 8 cm , 9 cm , 10 cm , 1 15 cm , 12 cm , 13 cm , 14 cm , 15 cm , 16 cm , 17 cm , 18 cm , 19 cm , 20 cm or a value in the range between any two of the aforementioned values, preferably between 10 and 14 cm . The above-mentioned dimensions are most preferably obtained when the nose mask adaptor is in the flattened condition, in other word measured on the sheet of heat moldable thermoplastic material. However, it will be appreciated that a curved nose mask adaptor can also be measured by transforming a digital model to a flattened

5 state or by measuring along its surface.

I n an embodiment the nose mask adaptor has a substantially triangular shape.

I n a further embodiment at least one angle of the triangular shape is provided with0 a fixture for a strap. Preferably each angle of the triangular shaped nose mask adaptor is provided with at least one fixture for a strap. The substantially triangular nose mask has preferably three fixtures.

I n an embodiment the nose mask adaptor has substantially the shape of an isosceles5 trapezium .

I n an embodiment of the invention, the device has a half conical or an isosceles trapezium shape. 0 I n an embodiment the coupling consists of at least one tubular connection means for coupling to a tube for providing a treatment. Said tubular connection means has an inlet through which the treatment will reach the subject’s nose. The inlet may be circular. The device maintains the position of the tube relative to the nose, perm itting the subject to receive a treatment for prolonged periods while being able5 to move the head freely. The coupling may be permanently or dismountably fixed to the device. Preferably, the coupling is permanently fixed to the device.

The opening of the device is dimensioned such as the entire nose of the subject passes there through. Hence, the device is suitable to contain the complete nose of0 a subject. The opening may be triangular, round, oblong, square of any other suitable shape. It may have the shape substantially of an isosceles triangle. The shape will be largely determined by the shape of the nose. Preferably, the opening is substantially triangular in shape. It is anticipated that different sizes of the device would be available to suit different sizes and shapes or nose masks, more in5 particular nose mask apertures.

I n an embodiment the device is dismountably fixed to the nose mask adaptor. The removable device can be dismounted and replaced after regular intervals or after sufficient wear and tear, so reducing the buildup of dust and allergens; the lifespan of the wearable system is thereby prolonged.

In an embodiment, a flange is provided around the opening of the device. The flange provides a gas-sealing effect against the nose mask adaptor. The flange of the device is dimensioned to fit around the aperture of the nose mask adaptor. The flange may be planar or flat in the native state. The flange is preferably oriented essentially perpendicular to the plane of the device opening. The flange is preferably formed from any suitable material exhibiting the requisite unfoldability property i.e. the ability to be folded and unfolded without weakening or other damage. Preferably, the flange is formed from the same material as the material of the device, most preferably silicone. The thickness of the flange and of the walls of the device will generally be determined by the material used for construction, and by the requisite unfoldability property i.e. the ability to be folded and unfolded without damage. However, as a general guidance, the minimum thickness will be equal to or less than 0.5 mm, 1 mm , 2 mm , 3 mm , 4 mm , or a value in the range between any two of the aforementioned values.

In an embodiment, the sheet of thermoplastic material comprises a thermoplastic composition layer having an upper surface and a lower surface and a support layer which is bonded on the lower surface of the thermoplastic composition layer.

In an embodiment, the sheet of thermoplastic material comprises a thermoplastic composition layer having an upper surface and a lower surface; a layer of elastic fabric; and a support layer. The layer of elastic fabric is bonded on the upper surface of the thermoplastic composition layer. The support layer is bonded on the lower surface of the thermoplastic composition layer.

In an embodiment, the sheet of thermoplastic material comprises a thermoplastic composition layer having an upper surface and a lower surface; a layer of elastic fabric; and a support layer. The layer of elastic fabric is bonded on the upper surface and the lower surface of the thermoplastic composition layer. The support layer is bonded on the elastic fabric which is bonded on the lower surface of the thermoplastic composition layer.

It is to be understood that the thermoplastic layer, the layer of elastic fabric and the support layer can be bonded to each other in any pattern. For instance, the thermoplastic composition layer can be sandwiched between two layers of elastic fabric whereby one layer of elastic fabric or each of them is bonded to a layer of support fabric. The thermoplastic composition layer can be sandwiched between two layers of support fabric whereby one layer of support fabric or each of them is bonded to a layer of elastic fabric. The thermoplastic composition layer can also be

5 sandwiched between a layer of elastic fabric and a layer of support fabric. Any other pattern is encompassed by the present invention. Wherein the sheet of thermoplastic material comprises a support layer, it is preferable that the nose mask adaptor produced from said sheet is used such as the support layer is in contact with the subject’s face. 0

I n an embodiment, the elastic fabric comprises yarns that are suitable for continuously bonding by heat to a thermoplastic material.

I n a preferred embodiment, the support layer comprises a foam , preferably a closed5 cell foam , more preferably a flexible closed cell foam . A closed cell foam is advantageous because it can be cleaned and used during about two weeks.

I n an embodiment the support layer comprises a foam suitable for continuously bonding by heat to a thermoplastic material and/or to an elastic material. 0

I n an embodiment the support layer comprises a foam suitable for continuously bonding to a thermoplastic material and/or to an elastic material by using an adequate adhesive. 5 I n a preferred embodiment, the support layer comprises a foam and an adhesive layer, whereby the adhesive layer is suitable for continuously bonding of said foam to a thermoplastic material and/or to an elastic material. The adhesive layer is based on acrylate and is suitable for medical and surgical applications. 0 I n an embodiment the density of said foam is comprised between 1 kg/m3 and 500, preferably between 10 and 450 kg/m3, more preferably between 20 and 400 kg/m3. The hardness of said foam is comprised between 0.5 and 30 kPa, preferably between 1 and 25 kPa, more preferably between 1 .3 and 20 kPa. The cell size of said foam , measured by scanning electron microscopy, is comprised between 0.05 and 5 mm,5 preferably between 0.08 and 4 mm , more preferably between 0.1 and 3 mm . Density, hardness and cell size of the foam can be measured by techniques known to a person skilled in the art. The foam can be of any color, preferably the foam have white color. I n an embodiment the open or closed cell foam is selected from the group of cellular polyvinyl chloride, polyolefins, polystyrene, styrene-acrylonitrile copolymer, styrene-methylmethacrylate copolymer. Preferably, open cell foam is polyurethane

5 open-cell foam . Preferably, closed cell foam is polyolefin closed-cell foam .

I n an embodiment, said foam is a breathable foam .

I n an embodiment the thermoplastic composition may be chosen from the group of0 polycaprolactone and polyurethane or any combination thereof.

The polyurethane may be present in an amount of 0% , 10% , 20% , 30% , 40% or 50% (% by weight) , preferably 20% to 40% or a value in the range between any two of the aforementioned values, most preferably 30% . The polycaprolactone may5 be present in an amount of 60% , 70% , 80% , or 90% (% by weight) or a value in the range between any two of the aforementioned values, preferably 60% to 80% , most preferably 70% . Typically, there will be more polycaprolactone than polyurethane which polycaprolactone lowers the temperature at which the sheet deforms. The ratio of polycaprolactone: polyurethane (weight:weight) may be 5: 1 ,0 4: 1 , 3:2, 3: 1 , 2.3: 1 , 2: 1 preferably 2.3: 1 .

The molecular weight of the polyurethane may be equal to or less than 10000, 20000, 30000, 40000, 50000, 60000, 70000, 80000, 90000, 100000, 120000, 140000, 150000 or a value in the range between any two of the aforementioned5 values, preferably between 10000 and 100000. Polyester polyurethane is the preferred polyurethane.

The molecular weight of the polycaprolactone may be 10000, 20000, 30000, 40000, 50000, 60000, 70000, 80000, 100000, 200000, 300000, 400000, 500000 or a value0 in the range between any two of the aforementioned values, preferably between 10000 and 60000, more preferably between 37000 and 500000.

Caprolactone polyester polyurethane is particularly suitable, which polyurethane may be obtained by reacting isocyanate and polycaprolactone-based polyester. 5 Such a caprolactone polyester polyurethane is commercially available as a granulate. The melting point of said polycaprolactone polyester polyurethane lies between 190°C and 210°C. By adding the polycaprolactone, also preferably in granulate form , a thermoplastic composition is obtained that is distortable and moldable at a temperature of about 69°C and remains distortable by cooling down about 30°C.

In an embodiment, the thermoplastic composition layer may have a thickness of 0.8 mm, 1.0 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6mm, 4.7 mm, 4.8 mm, 4.9 mm, 5.0 mm, 5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm or 6.0 mm or a value in the range between any two of the aforementioned values.

In one embodiment, the thermoplastic composition layer comprises between 1% to 40% (weight %) of microspheres of non-metallic, heat-accumulating material which is especially suited for heating in a micro-wave oven. Preferred are glass microspheres with a diameter between 20pm and 800pm. A coloring agent may be added to the composition.

In an embodiment, the thermoplastic composition layer is provided with perforations to increase breathability. The perforations may have a diameter of 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm or a value in the range between any two of the aforementioned values.

A non-limiting example of a thermoplastic composition that can be used in the current invention is Turbocast® (T Tape Company BV).

In an embodiment breathable fabrics of the present invention have a water vapor transmission rate WVTRs comprised between 1 and 2000 g/m ² per 24 hours, preferably between 2 and 1800 g/m ² per24 hours, more preferably between 3 and 1600 g/m ² per 24 hours, most preferably between 3 and 1400 g/m ² per 24 hours.

In a preferred embodiment of the invention, the elastic fabric has an elasticity comprised between 0.5% and 100% in the x and/or y direction. More by preference, the elastic fabric has an elasticity comprised between 1% and 15% in the x and/or y direction. Most by preference, the elastic fabric has an elasticity comprised between 2% and 5% in the x and/or y direction. The elastic fabric is a flat sheet-like product which has very sm all height com pared to the dimensions of length and width. The x and y direction are defined to be respectively the length and the width of the support layer, whereas the z direction is defined as the height.

An elasticity of 100% in the x direction m eans that the elastic fabric will elongate to twice its original length upon applying an external force on said support layer and after said external force is removed, the elastic fabric will return to its original length without loss of m aterial properties. The term “elasticity in x direction” can be expressed as the ratio of the elongation upon application of an external force to the initial length of the m aterial in which said force is applied. This definition holds m utatis m utandis for “elasticity in the y direction”.

I n an em bodim ent of the invention, the elasticity of the elastic fabric is sim ilar in x direction and y direction .

I n one em bodiment of the invention , the elasticity of the elastic fabric is equal in x and y direction .

I n another em bodiment of the invention, the elasticity in x and y direction is different, by preference is the elasticity in y direction com prised between 20%-70% of the elasticity of the x direction . Such m aterial will be suitable for molding a nose mask adaptor in which the deform ation in x direction will be more detailed than the deformation in y direction .

I n a preferred em bodiment of the invention , the elastic fabric comprises a woven fabric whereby the warp and/or weft yarn are elastic thread.

I n another em bodim ent of the invention, the elastic fabric is a knitted fabric. The elastic fabric can be made according to the knowledge available in the prior art.

When the elastic fabric is a knitted m aterial, it comprises by preference a polyam ide- based knitted fabric material with a thickness of between 0.05 and 1 .5 m m . I n one em bodim ent of the invention, the knitted fabric material is form ed from a yarn com prising between 80 % to 95 % polyam ide, and between 5 % and 15 % elastane, preferably comprising 90 % polyam ide and 10 % elastane. Suitable yarns for the elastic fabric com prise but are not lim ited to: polyam ide, elastane, polyester, elasticated neoprene and styrene rubber or any other elasticated material suitable for weaving or knitting.

I n a preferred embodim ent of the invention, the elastic fabric is suitable for freely following the deformations of the thermoplastic com position layer, during and after molding of the sheet of thermoplastic m aterial. The elastic fabric will give support to the sheet of thermoplastic m aterial when it is in moldable phase but during hardening and molding of the thermoplastic com position , the elastic fabric freely follows the expansions and contractions of the thermoplastic com position . When the thermoplastic composition is rigid, the elastic fabric is fully adapted to the form of the sheet of thermoplastic material and thereby to the form of the obtained nose mask adaptor.

I n a preferred embodim ent, the elastic fabric and/or the support layer can be uncoated, coated and/or im pregnated.

I n an embodim ent of the invention, the elastic fabric and/or the support layer is coated with a polymer. By preference, the polym er is chosen from the group com prising but not lim ited to elastom ers such as ethylene-vinyl acetate, ethylene propylene rubber, silicone rubber; polyester, breathable polyurethane; and synthetic silicone. The elastic fabric and/or the support layer m ay be coated on one side or on both sides. The advantage of using polym er coating is that when it is applied to an elastic fabric, the coating will not alter the elastic properties of said elastic fabric. The coating will follow the expansion and contraction of the fabric freely.

I n a preferred em bodiment of the invention, the coating of the elastic fabric consists of silicone-foam , which can be m ade of synthetic silicone or natural silicone. Such foam has the advantage that it provides high flexibility and perm eability.

I n another em bodim ent of the invention, the support layer is coated with a coating consisting of silicone-foam , which can be made of synthetic silicone or natural silicone. The silicone-foam is breathable and has the advantage that it provides high flexibility and permeability. Moreover, when a silicone-foam is applied to a hydrophilic cell foam , the coating will not alter the breathability of said hydrophilic cell foam and thereby the breathability of the sheet of thermoplastic m aterial. I n another preferred embodiment of the invention, the coating optionally comprises a backing layer or liner which is removed before application to the subject. The backing layer reversibly adheres to the silicone layer of the coating intended for contact with the skin of the subject. Said silicone layer is sticking to the skin of the

5 subject. The silicone layer can be a silicone pressure sensitive adhesive. The backing layer may be made of any suitable material such as, for example, polyethylene, polythene or other polymeric substance. According to an aspect of the invention, the backing layer is smooth, or is regularly patterned with pits or grooves. 0 I n another embodiment of the invention, the elastic fabric and/or the support layer is impregnated. By preference, the elastic fabric and/or the support layer is impregnated with a polymer. More by preference, the polymer is chosen from the group comprising but not limited to elastomers such as ethylene-vinyl acetate, ethylene propylene rubber, silicone rubber; polyester; synthetic silicone. 5

I n a preferred embodiment of the invention, the elastic fabric is a silicone-coated elastic fabric whereby the silicone-coating is applied on the surface which is not bonded to the thermoplastic composition layer. The support layer is a silicone- coated foam whereby the silicone-coating is applied on the surface which is not0 bonded to the thermoplastic composition layer. The silicone coating can form ridges on the elastic fabric and/or the support layer or it can be smooth. The silicone coating can form a continuous layer or a discontinuous layer. The silicone coating can be applied in an amount of 5g/m ² to 25g/m ² , preferably from 7g/m ² to 20g/m ² . I n another embodiment of the invention, the elastic fabric is covered with a silicone5 coating in an amount between 25g/m ² to 1000g/m ² .

A silicone-coated elastic fabric and silicone-coated foam have the advantage that the silicone will act as a friction restraining material. Silicone-coated fabrics, such as textile, are known in the prior art and provide comfort to the subject when the0 silicone coated side is the skin facing side of the fabric. Silicone reduces the friction between a textile and the skin. Another advantage of silicone is its heat resistance capacity. This will buffer the heat of the sheet of thermoplastic material when it is directly molded on the skin. Another advantage of silicone is that it is vapor- permeable. An embodiment of the invention in which the elastic fabric and/or the5 support layer is silicone-coated is suitable to create a m icro-climate where it is applied. Such m icro-climate will allow for an accelerated healing of burns and or dermatologic scars and it will lessen permanent scars on the skin. In an embodiment, the present invention provides a breathable thermoplastic sheet comprising a thermoplastic composition layer, a support layer bonded on one surface of the thermoplastic composition layer. The thermoplastic composition layer is preferably provided with perforations. Said support layer is preferably polyurethane open cell foam which is coated and/or impregnated with a breathable silicone elastomer. Thus, the thermoplastic sheet exhibit good breathability and improved wear comfort which is advantageous for the subject.

The thickness of the support layer is equal to or less than 0.025 mm, 0.05 mm, 0.06 mm, 0.08 mm, 0.1 mm, 0.5 mm, 0.8 mm, 1 mm, 1.2 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm or a value in the range between two of the aforementioned values. The thickness will depend on the thickness of hydrophilic foam , and the coating. A silicone- foam coated hydrophilic foam will have higher thickness than a non-foam coating.

In an embodiment, the elastic fabric is disposed on the thermoplastic composition layer and bonded to it during the production process of the sheet of thermoplastic material. In a preferred embodiment, the elastic fabric is heat-bonded to the thermoplastic composition layer. Said heat-bonding is performed at a temperature of 70°C-120°C depending on the thermoplastic composition. At this temperature, the thermoplastic composition layer is melted and bonds to the elastic fabric by virtue of the adhesive property of the thermoplastic composition layer in its melted condition. Additional adhesives or glue can be added but are not required. Where the support layer is directly bonded to the thermoplastic composition layer , a similar bonding method can be applied.

In a preferred embodiment of the invention, the support layer is continuously bonded to the thermoplastic composition layer.

In another embodiment of the invention, the support layer is not continuously bonded, leaving some of the surface area of the thermoplastic composition layer not bonded to the support layer.

Similarly, the elastic fabric is continuously or not continuously bonded to the support layer.

In an embodiment the overall thickness of the sheet of thermoplastic material 15 may be 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.2 mm, 2.4 mm, 2.5 m m , 2.6 mm , 2.7 mm , 2.8 m m , 2.9 m m , 3.0 m m , 3.1 m m , 3.2 mm , 3.3 m m , 3.4 mm , 3.5 mm , 3.6 m m , 3.7 m m , 3.8 m m , 3.9 mm , or 4.0 mm or a value in the range between any two of the aforementioned values.

5 I n an embodiment the sheet of thermoplastic material according to the invention is by preference moldable at temperatures of between 40°C and 90°C, more by preference between 50°C and 70°C. This temperature is depending on the polycaprolactone content of the sheet material. The sheet material will remain in a plastic condition until it is cooled below 30°C. Typically the sheet is brought into the0 moldable state by heating in a water bath set around 5°C above the melting temperature, most preferable at 65°C. Alternatively, the sheet of thermoplastic material can be heated using a convection or fan oven, a m icrowave oven or a hair dryer or by any other heat producing apparatus or method. 5 When handling an unsupported thermoplastic sheet while it is in a moldable state, initial deformations occur in the thermoplastic composition, such as impression of fingers or gloves which make contact with the sheet. An unsupported thermoplastic sheet also deforms under its own weight when it is reheated prior to molding. A preferred embodiment of the sheet of thermoplastic material according to the0 invention will counteract these deformations due to the elastic properties and/or due to the additional strength provided by a coating or impregnation. As a result, a thermoplastic sheet according to the invention will keep its original form until it is molded during its plastic phase. The characteristics of the sheet of thermoplastic material will allow for wanted deformation of the thermoplastic material upon5 application of external forces, such as during molding.

The sheet of thermoplastic material remains by preference in the moldable state for 1 -10 minutes, more by preference between 2-5 minutes. The elastic fabric or the foam are capable of freely following the expansion and the contraction of the0 thermoplastic composition layer while the sheet of thermoplastic material hardens during and after molding.

I n a preferred embodiment of the invention, the sheet of thermoplastic material comprises a Turbocast® thermoplastic composition on one surface of which a closed5 cell foam , preferably polyolefin closed cell foam , is disposed. On the other surface, a silicone-coated elastic fabric is disposed. The fabric has elasticity in the y direction comprised between 20% and 70% of the elasticity in the x direction. The sheet, according to the present invention, can directly be molded on a person and is suitable for the use as a nose mask adaptor whereby the polyolefin closed cell foam will be the skin-facing layer. The resulting nose mask will provide a comfortable wearing and the support layer prevents adhesion to the skin and/or hair

5 by the thermoplastic composition. The sheet exhibits excellent deformability properties, conform ing to the shape of the nose without the need to apply excessive pressure. The polyolefin closed cell foam provides a comfortable wearing against the skin. 0 I n an embodiment of the invention, the sheet of thermoplastic material may be pre formed prior to molding. I n another embodiment of the invention, the sheet of thermoplastic material is available in different standard dimensions.

I n an embodiment, the support layer may contain anti-bacterial products. This is5 beneficial to avoid bacterial infections by using the wearable system .

I n an embodiment the thermoplastic material of the present invention is characterized by a memory effect. Said memory effect is very advantageous as it avoids deformation and/or a return to the layer status of the hardened thermoplastic0 material and hence of the anatom ical shaped nose mask adaptors after certain treatments, such as sterilization and/or washing at high temperatures (from 85 to 100°C) .

I n an embodiment, the fixation means is a glue, tape or other suitable means to5 attach the said device to the nose mask adaptor.

I n an embodiment, the device comprises fixtures for straps. The fixtures and straps are sim ilar as in previously described embodiments of the nose mask adaptor comprising fixtures and straps. The fixtures and straps are suitable to retain the0 device in position around the aperture of the nose mask adaptor and to retain the nose mask adaptor and the device in place on the subject’s face. A device comprising fixtures and straps is beneficial because the fixtures and straps are suit for the dual purpose of keeping the device and the nose mask adaptor in place and as fixation means to fixate the device to the nose mask adaptor. 5

I n a preferred embodiment, the fixation means comprises a first and a second part, wherein the said nose mask adaptor comprises the first part and wherein the said device comprises the second part and wherein the first and second part are configured to attach to each other. This is beneficial to keep the device in place around the aperture of the nose mask adaptor, even while the subject is sleeping. Preferably this is combined with a nose mask adaptor which comprises fixtures for straps. This is additionally beneficial to assure that the device remains in the correct

5 position on the subject’s face.

I n a further embodiment, the fixation means comprises at least one snip fit attachment, wherein the first part is a protrusion and the second part an opening such that the opening is clickable on said protrusion thereby dismountably attaching0 the device to the nose mask adaptor.

I n another embodiment, the fixation means comprises at least one piece of hook- and-loop fasteners, hook-and-pile fasteners, touch fasteners or a sim ilar means, wherein the first part comprises the hooks and the second part the loops or piles,5 or vice versa, thereby dismountably attaching the device to the nose mask adaptor.

I n another embodiment, the fixation means comprises press-stud or snap-fastener, wherein the first part of the fixation means comprises a first element of the press- stud or snap-fastener and the second part of the fixation means comprises a second0 reciprocating element.

I n another embodiment, the fixation means comprises a flange and a deformable groove. Preferably the groove is the first part of the fixation means. Preferably the flange is the second part of the fixation means. The flange is preferably provided5 around the opening of the device. The groove is deformable so that the flange can be inserted in the groove, wherein after insertion the groove encloses the flange. A deformable groove is additionally beneficial to adapt to deformations of the device and/or nose mask adaptor, avoiding the detachment of the device from the nose mask adaptor. A non-limitative example of a suitable material for the groove is0 silicone. A non-limitative example of a suitable material for the groove is silicone.

I n an embodiment the device is made of flexible material. This is beneficial because the device can follow the contours of the subject’s face. A non-lim itative example of a suitable material is silicone. 5

I n an embodiment, the device is configured to be at least partly movable and partly deformable around the aperture while being fixated on the nose mask adaptor. Preferably while being moved and/or deformed, the device remains fixated on the nose mask adaptor around the whole circumference of the opening of the device. This is beneficial to avoid that the correct positioning of the device on the subject’s face is lost due to movements of the subject, for instance while sleeping.

5 I n a preferred embodiment, the wearable system comprises a device made of a flexible material and a fixation means, comprising a flange and a deformable groove, wherein the device is configured to be at least partly movable and partly deformable around the aperture while being fixated on the nose mask adaptor. The advantages of such a wearable system are as described in previous embodiments. 0

I n a second aspect, the invention is related to a kit for delivery of a treatment through the nose of a subject.

I n a preferred embodiment the kit comprises a sheet of thermoplastic material as5 described in previous embodiments of the first aspect of the current invention, suitable for form ing a nose mask adaptor, a device as described in previous embodiments of the first aspect of the current invention, at least one fixation means configured to fixate the said device on the said nose mask adaptor as described in previous embodiments of the first aspect of the current invention, and at least one0 pressurizing means configured for applying pressure on the said sheet of thermoplastic material during thermoform ing.

The kit is advantageous for the reason that with a lim ited of thermoplastic materials and deform ing steps, a wearable system for delivery of treatment through the nose5 of a subject in a comfortable, performant and secure manner can be obtained. The pressurizing means ensure a good molding of the thermoplastic sheet and thereby an optimized fitting of the nose mask adaptor.

I n a preferred embodiment, said pressurizing means comprise binder clips or pincer0 shape. This is beneficial because it allows to ensure a good deformation of the sheet against the subject’s face, especially around the subject’s nose and when required to maintain pressure while the sheet is cooling down to a rigid state.

I n a third aspect, the invention is related to the use of a kit according to the second5 aspect of the current invention for molding directly a nose mask adaptor on a subject for delivery of a treatment through the nose of said subject. This use is beneficial because the kit is adapted for form ing a wearable system for delivery of treatm ent through the nose of a subj ect in a comfortable, performant and secure m anner, while only a lim ited amount of thermoplastic m aterials and deform ing steps are required.

5

Although the present invention has been described with reference to preferred em bodim ents thereof, m any modifications and alternations may be m ade by a person having ordinary skill in the art without departing from the scope of this invention which is defined by the appended claims. 0

The invention is further described by the following non-lim iting figures which further illustrate the invention , and are not intended to, nor should they be interpreted to, lim it the scope of the invention . 5

FIGURES

FI G. 1 shows a sheet (15) of heat moldable thermoplastic material according to the present invention. The sheet (15) is in a non-molded state. This resembles a nose mask adaptor (2) before molding. The sheet (15) comprises a substantially inverted T shape comprising a slit (16), which extends to a lower opening (20), which opening (20) is substantially extending perpendicular to the slit (16), whereby the slit (16) delimits two flanking flaps (4) and (5). The slit (16) of the sheet (15)of heat moldable thermoplastic material is also extending to an upper opening (19).

FI G. 2 shows a nose mask adaptor (2) according to the present invention. The nose mask adaptor (2) is obtained by molding the sheet (15) of heat moldable thermoplastic material shown in Fig. 1 on a subject’s nose. After molding, the two flanking flaps (4) and (5) are bent outwards and an aperture (3) for the nose is formed. The aperture (3) has a width (BT) and a height (HT). The nose mask adaptor (2) has a longitudinal length (L) and perpendicular thereto a width (W)

FI G. 3 shows an embodiment of a wearable system according the current invention, by fixating the device (6) shown in FI G. 4a on the nose mask adaptor (2) shown in FIG. 2. The device (6) fits around the aperture (3) of the nose mask adaptor (2) and rests on the nose mask adaptor (2). The device (6) is provided at one end with an opening (25) for receiving the subject’s nose and at the other end with a coupling (7) suitable to be connected to one or more tubes for delivery of the treatment through the nose. The coupling (7) consists of at least one tubular connection means (26) for coupling to a tube for providing a treatment. Said tubular connection means (26) has an inlet (27) through which the treatment will reach the subject’s nose. A flange (28) is provided around the opening (25) of the device (6).

FIG. 4a shows a device (6) configured to fit around the aperture of the nose mask adaptor (2) . The device (6) corresponds to the device (5) of FI G. 3.

FIG. 4b shows a cross section view according to A-A of the device (6) shown in

FIG. 4a.

FI G. 5a is a perspective view of the nose mask adaptor (2) of FI G. 2 on a subject’s face. The sheet (15) extends across at least part of the cheek bones of the subject, whereby the nose bridge protrudes at least partially through the slit (15), the nose nostrils protrude at least partially through the lower opening (20) ; and each lateral side of the nose is at least partially covered by a flanking flap (4) or (5) .

FI G. 5b is a perspective view of a wearable system according to an embodiment of the current invention on a subject’s face, comprising the nose mask adaptor (2) of FI G. 5a and the device (6) of FI G. 4a. The device (6) fits around the aperture (3) of the nose mask adaptor (2) and rests on the nose mask adaptor (2) . The device (6) covers the aperture (3) .

FI G. 6 shows an alternative of a sheet (15) of heat moldable thermoplastic material according to the present invention, comprising a second aperture (30) for the subject’s mouth. The sheet (15) is in a non-molded state.

FI G. 7 is a perspective view of a nose mask adaptor (2) formed of the sheet (15) of FI G. 6 on a subject’s face. The position of the second aperture (30) corresponds with the position of the subject’s mouth.

FI G. 8 is a perspective view of a wearable system according to an embodiment of the current invention on a subject’s face, comprising the nose mask adaptor (2) of FI G. 7 and a device (6) according to an embodiment of the current invention. The device (6) is configured to fit around the aperture (3) of the nose and the second aperture (30) of the mouth and to cover the aperture (3) of the nose and the second aperture (30) of the mouth.

FI G. 9 shows an alternative of a sheet (15) of heat moldable thermoplastic material according to the present invention, comprising a first part (32) of a fixation means. The sheet (15) is in a non-molded state. The first part of the fixation means is a deformable groove (32) . The sheet (15) further comprises press-studs (31 ) for attaching straps.

FI G. 10 shows a nose mask adaptor (2) according to the present invention. The nose mask adaptor (2) is obtained by molding the sheet (15) of heat moldable thermoplastic material shown in Fig. 9 on a subject’s nose.

FI G. 1 1 shows an embodiment of a wearable system according the current invention, by fixating an alternative embodiment of a device (6) , comprising a second part of a fixation means, on an alternative embodiment of a nose mask adaptor (2) , comprising a first part of a fixation means. The first part of the fixation m eans is a deform able groove (32) . The second part of the fixation means is a flange (34) . The flange (34) is provided around the opening (25) of the device. The groove (32) is deformable so that the flange (34) can be inserted in the groove (32) , wherein after insertion the groove (32) encloses the flange (34) . The nose m ask adaptor (2) further com prises fixtures (33) for straps. The fixtures (33) are single slots.

FI G. 12 shows a cross section view according to B-B of the wearable system shown in Fig. 1 1 . The groove (32) encloses the flange (34) after insertion.