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GB2543360A - Nose Protector for a face mask - Google Patents

Nose Protector for a face mask Download PDF

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Publication number
GB2543360A
GB2543360A GB201518373A GB201518373A GB2543360A GB 2543360 A GB2543360 A GB 2543360A GB 201518373 A GB201518373 A GB 201518373A GB 201518373 A GB201518373 A GB 201518373A GB 2543360 A GB2543360 A GB 2543360A
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GB
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Application
Patent type
Prior art keywords
pressure
nose
protector
distributor
face
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
GB201518373A
Other versions
GB201518373D0 (en )
GB2543360B (en )
Inventor
Jack Hope Simon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Catherine Hope
Original Assignee
Catherine Hope
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Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0618Nose

Abstract

A nose protector 10 for a face mask worn by a user, the nose protector 10 comprising a pressure distributor 2 having a curved shape to fit snugly to the user's nasal bridge, wherein the pressure distributor 2 is rigid enough to maintain its curved shape and distribute pressure from the face mask to the user. The nose protector 10 may comprise a lateral adhesive section 1 and a compressible pad 3 acting to improve fit, which may be gel or foam. The nose protector may be detachably connectable to a face mask or be a separate component.

Description

NOSE PROTECTOR FOR A FACE MASK This invention relates to a nose protector for a face mask.

Patients may need to wear a face mask in medical situations. For example, a patient may wear a face mask when they require more oxygen to treat hypoxia, i.e. low oxygen levels in the blood. As another example, a patient may need to wear a face mask if they require a form of non-invasive ventilator support, for example to treat hypoxia or hypercapnia. As a further example, a patient may need to wear a face mask for use at home for the treatment of a chronic health condition such as obstructive sleep apnoea, chronic obstructive pulmonary disease or a neurological condition, for example.

Examples of face masks include a full face mask that covers the nose and mouth, and a nasal mask that covers the nose but not the mouth. Types of full face mask include a simple face mask, a partial rebreather mask, a non-rebreather mask and a venturi mask. Face masks are often provided with straps that extend around the patient’s head so as to keep the face mask in position. Face masks are often required to be worn by the patient for extended periods of time, such as for many hours a day.

There is a risk of skin damage and/or ulcers occurring particularly on the bridge of the nose. Such an ulcer is a localised injury to the skin and/or underlying tissue over the bridge of the nose.

It is desirable to reduce the possibility of skin damage and/or ulcers occurring as a result of wearing a face mask.

According to the present invention there is provided a nose protector for a face mask worn by a user, the nose protector comprising: a pressure distributor having a curved shape configured to fit snugly to the user’s nasal bridge, wherein the pressure distributor maintains its curved shape such that it has rigidity so as to distribute pressure from an interface point between the face mask and the nasal bridge along the user’s nasal ridge corresponding to where the pressure distributor is fitted.

An embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 illustrates a nose protector according to an embodiment of the invention worn by a user;

Figure 2 illustrates a face mask with a nose protector according to an embodiment of the invention worn by a user;

Figure 3 illustrates a nose protector according to an embodiment of the invention worn over the bridge of the nose;

Figure 4 illustrates a nose protector according to an embodiment of the invention; and Figure 5 illustrates a side-on view of the a nose protector shown in Figure 4.

An example of a nose protector 10 according to an embodiment of the invention is illustrated in Figure 1. The nose protector 10 is for a face mask 20 (see Figure 2) that is worn by a user. In use, the nose protector 10 is worn by the user. The nose protector 10 is suitable for use with the face mask 20. For example, the nose protector 10 may be adapted to interface with the face mask 20.

The nose protector 10 may be a separate item from the face mask 20. The nose protector 10 can be manufactured, packaged and sold separately from the face mask 20, for example. The nose protector 10 is adapted for use with the face mask 20. The nose protector 10 may be configured to be stuck to the nose of the user and/or to the face mask 20 to keep it in position. The nose protector 10 may comprise an adhesive section 1 for adhering the nose protector 10 to the nose of the user. Additionally or alternatively, the nose protector 10 comprises an adhesive section 1 for adhering the nose protector 10 to the face mask 20.

The nose protector 10 may be detachably connectable to the nasal bridge and/or to the face mask 20. The detachable connection(s) may be by an adhesive. When the nose protector 10 is detachably connectable to the nasal bridge but not the face mask 20, the nose protector 10 contacts the face mask 20 in use but is not fixed to it. Instead the face mask 20 may move slightly with respect to the nose protector 10, although the pressure of the face mask 20 on the face (e g. due to the straps of the face mask 20) may be sufficient to hold the face mask 20 in place with respect to the nose protector 10.

When the nose protector 10 is detachably connectable to the face mask 20 but not the nasal bridge, the nose protector 10 contacts the nasal bridge in use but is not fixed to it. However, the nose protector 10 may comprise a pressure distributor 2 having a curved shape configured to fit snugly to the user’s nasal bridge, such that the snug fit may be sufficient to hold the nose protector 10 in place with respect to the nasal bridge.

By providing the nose protector 10 as a separate item from the face mask 20, the nose protector 10 can be used to protect the nose of the user when they are wearing a face mask of the type that has an edge that puts pressure on the nasal bridge of the user. The nose protector 10 may be used with different types of face mask.

The nose protector 10 of the present invention is appropriate for use with all methods of oxygen delivery and non-invasive ventilation (e.g. pressure regulated, volume regulated or both) that is delivered by a face mask 20. A face mask 20 may cover both the nose and mouth together, or just the nose.

As depicted in Figure 1, the nose protector 10 comprises a pressure distributor 2. The pressure distributor 2 is a component of the nose protector 10. The pressure distributor 2 may comprise a substrate.

The pressure distributor 2 has a curved shape configured to fit snugly to the user’s nasal bridge. Because the pressure distributor 2 fits snugly to the nasal bridge, a good seal is provided between the face mask 20 and the nasal bridge. The snug fit reduces the possibility of gaps between the face mask 20 and the face of the user through which gases can flow. Accordingly, the nose protector 10 of the invention is different from items that perform functions such as dilating a nose, which are not required to have a snug fit to the nasal bridge.

The pressure distributor 2 has two major surfaces, one that faces towards the face mask 20 and one that faces towards the user. The snug fit of the pressure distributor 2 to the nose means that substantially the whole of the surface facing the user contacts the user’s face or substantially the whole of the surface facing the user contacts another layer of the nose protector 10 (e.g. an adhesive section 1 or a compressible pad 3, as described below), wherein substantially the whole of that other layer’s user-facing surface contacts the user’s face. Accordingly, the pressure distributor 2 is adapted to distribute pressure over as wide an area as possible. Peaks of pressure on the user’s face are reduced. The user-facing surface of the pressure distributor 2 may be substantially smooth so as to avoid the creation of high-pressure points on the user’s face.

The pressure distributor 2 maintains its curved shape. Even when the nose protector 10 is not being worn by the user, the pressure distributor 2 maintains its curved shape. The curved shape provides stiffness to the pressure distributor 2. When the nose protector 10 is not being worn by the user, the pressure distributor 2 is self-supporting. The pressure distributor 2 can support its own weight and maintain its shape when not in use. Accordingly, the pressure distributor 2 of the invention is different from gel strips, for example, that can be placed across the nasal bridge but that do not maintain their shape, particularly when not being worn by the user.

The pressure distributor 2 of the invention maintains its curved shape such that it has rigidity so as to distribute pressure from an interface point 22 between the face mask 20 and the nasal bridge along the user’s nasal ridge corresponding to where the pressure distributor 2 is fitted. The pressure distributor 2 is configured to distribute the pressure produced at the interface point 22 between the face mask 20 and the nasal bridge. As shown in Figure 2, the interface point 22 between the face mask 20 and the nasal bridge may be a single point or a small localised region. The interface point 22 is the position at which the face mask 20 would contact the user if the nose protector 10 were not being used.

By using the nose protector 10 of the present invention, the pressure is dispersed from the single point on the nasal bridge along the length of the nasal ridge where the pressure distributor 2 is fitted. Hence instead of the pressure of the face mask 20 being applied at a single point on the nasal bridge, the pressure is applied more or less evenly across a larger area, which substantially corresponds to the area of the pressure distributor 2.

The interface point 22 is the point at which the rim 21 (i .e. an edge) of the face mask 20 would otherwise contact the nose. Hence the nose protector 10 is particularly effective when used with the type of face mask 20 that has a hard, thin edge that contacts the nose of the wearer.

The nose protector 10 may extend along substantially the whole of the nasal ridge. If so, then the pressure is dispersed along substantially the entire length of the nasal ridge. The entire length of the nasal ridge means from the nasal root to the nose tip.

The nasal ridge is the prominent midline of the nose that extends from the nasal root to the nose tip. The nasal root is the most depressed, superior part of the nose along the nasal bridge. The nasal bridge is a saddle-shaped area that includes the nasal root and the lateral aspects of the nose.

An ulcer is a localised injury to the skin and/or underlying tissue. The present inventor found that ulcers are often found on nasal bridges because the nasal bridge is a bony prominence. The present inventor found that ulcers can be the result of pressure, or pressure in combination with shear. Accordingly, by providing the pressure distributor 2 that distributes pressure from the interface point 22 along the nasal ridge, the possibility of an ulcer forming is reduced.

By using the nose protector 10, the peak pressure applied to the user is reduced.

Additionally, shear forces on the skin can be reduced. In turn, this reduces the likelihood of the formation of a pressure ulcer. Accordingly, the nose protector 10 functions as a pressure damage prevention dressing.

In some situations, a face mask is required for continuous positive airway pressure therapy. Continuous positive airway pressure therapy requires a tight seal for effective therapy. The tightness of the seal required increases the possibility of pressure damage to the skin. In such situations, pressure ulcers over the bridge of the nose can be particularly common. It has previously been suggested that some pressure damage is unavoidable when lifesaving treatment is required. By using the nose protector 10 of the invention, the possibility of pressure damage can be reduced or avoided altogether.

The nose protector 10 may also reduce the need for straps of the face mask 20 to be tightened to reduce leakage, because of the snug fit between the pressure distributor 2 and the nasal bridge.

The nose protector 10 of the present invention is a medical device for the prevention and treatment of pressure ulcers on the bridge of the nose caused by face masks 20 for the delivery of oxygen and non-invasive ventilator support, for example. Such uses of face masks 20 can include continuous positive airway pressure, bi-level positive airway pressure and volume regulated ventilator support. Although the nose protector 10 of the present invention is primarily for the prevention of ulcers, use of the nose protector 10 can also allow an existing ulcer (or an ulcer that is in the process of being formed) to heal when the nose protector 10 is used. The nose protector 10 can be called nose armour because of its protective function. The nose protector 10 can be called a Nose Knight because of its protective function and because it can be worn at night. The nose protector 10 is adapted for being worn overnight.

If the nose protector 10 is not used, then skin breakdown can occur at the site of mask contact, i.e. at the interface 22. Skin breakdown can occur even after only a few hours of ventilation. Skin breakdown is a frequent complication that has been found to occur in 2 to 23% of cases. In one study, where patients were continuously ventilated with a face mask for more than 48 hours, the percentage of cases where skin breakdown occurred was 70%.

In the National Institute for Health and Care Excellence Costing Statement: Pressure Ulcers (CG179) published in April 2014, it is stated that “The daily costs of treating a pressure ulcer are estimated to range from £43 to £374. For ulcers without complications, the daily cost ranges from between £43 to £57. These costs assume that patients are cared for in a hospital or long-term care setting but are not admitted solely for the care of a pressure ulcer. These are the daily costs in addition to the costs of standard care.” Accordingly, the nose protector 10 of the present invention is expected to achieve a reduction in the costs for care of patients using face masks in hospitals or long-term care settings.

For patients who are reliant on the ventilator support delivered by a face mask to sleep, a pressure sore could ultimately mean a matter of life or death if no other methods of ventilation are suitable.

The pressure distributor 2 of the nose protector 10 may be rigid. This means that the pressure distributor 2 retains its shape when not in use and unless it is subjected to high forces. In contrast, a gel strip is not rigid because it does not hold its shape. A gel strip could not distribute pressure from the interface point 22 along the nasal ridge. Instead, even if the gel strip were to enhance the fit of the face mask 20, the pressure would remain localised to the interface point 22 between the face mask 20 and the nasal bridge, or to a localised region adjacent to the interface point 22.

As shown in Figures 1 to 3, the nose protector 10 is a device that is placed over the human nose. The pressure distributor 2 is a curved central section that lies over the bridge of the nose. In use, the nose protector 10 is worn such that the pressure distributor 2 is placed centrally to distribute pressure from the interface point 22 caused from the face mask 20. The pressure is distributed across the length of the bridge. The pressure can be distributed across the width of the nose, at least as far as the pressure distributor 2 extends.

The pressure distributor 2 may be semi-rigid. Semi-rigid means that the pressure distributor 2 holds its curved shape even when not in use and is sufficiently rigid to distribute the pressure from the pressure point. However, the pressure distributor 2 may not be perfectly rigid, such that the pressure distributor 2 can conform to the size and shape of the particular nose of the user. Nose bridges come in different sizes and shapes. The pressure distributor 2 may have flexibility to allow the snug fit between the pressure distributor 2 and the nasal bridge.

The pressure distributor 2 may be formed of a single piece of material. Accordingly, the nose protector 10 is easier to manufacture. By providing that the pressure distributor 2 is formed of a single piece of material, the pressure can be distributed more evenly and reliably by the pressure distributor 2. This is because there are no breaks or rough sections in the pressure distributor 2 that could result in the pressure distributor 2 bending or otherwise causing high pressure on a single point of the nasal bridge.

The pressure distributor 2 may have a maximum thickness of at most 1 mm. Accordingly, the pressure distributor 2 is a very thin device. The thinness of the pressure distributor 2 reduces the possibility of any changes in pressure leak or oxygen levels that may be imperative for effective medical therapy using the face mask 20. The pressure distributor 2 may have a maximum thickness of at most 0.5 mm. The pressure distributor 2 may have a substantially uniform thickness throughout its width and/or length.

As explained above, the pressure distributor 2 has rigidity so as to distribute pressure from an interface point 22 between the face mask 20 and the nasal bridge along the nasal ridge corresponding to where the pressure distributor 2 is fitted. The pressure distributor 2 may have a minimum thickness of at least 0.2 mm, optionally at least 0.5 mm. By providing that the thickness of the pressure distributor 2 is at least 0.2 mm, the pressure distributor 2 is strong such that it does not significantly deform in shape when the nose protector 10 is worn together with a face mask 20.

The pressure distributor 2 may be sized to extend at least 25 mm along the user’s nasal ridge. The pressure distributor 2 may have a length of at least 25 mm. By providing that the pressure distributor 2 extends at least 25 mm along the nasal ridge, the pressure can be distributed over a significant area so as to reduce the possibility of an ulcer being formed due to the pressure in a localised area. However, it is not necessary for the pressure distributor 2 to be as long as 25 mm. The pressure distributor 2 can have a length that is less than 25 mm, for example in the range of from about 10 mm or 15 mm to about 25 mm.

The pressure distributor 2 may have a length of at most 45 mm. By providing that the pressure distributor 2 has a length of at most 45 mm, a better fit of the nose protector 10 onto the nose of the user can be achieved. The pressure distributor 2 may be sized such that it does not extend beyond the nasal root or beyond the nose tip. Of course, different sizes of nose protector 10 (and hence pressure distributor 2) may be provided for differently sized noses. The nose protector 10 comes in different sizes.

The pressure distributor 2 may have a width of at least 10 mm. By providing that the width of the pressure distributor 2 is at least 10 mm, the pressure can be distributed to regions of the nasal bridge beyond (i.e. on either side of) the nasal ridge. The pressure distributor 2 may have a width of at most 20mm. By providing that the width of the pressure distributor 2 is at most 20 mm, the pressure distributor 2 can fit snugly to the nasal bridge while requiring only one curve in it. A pressure distributor 2 that is so wide that its edges reach the crease between the nose and the rest of the face would either not fit snugly (e g. a gap would open between the nose and the pressure distributor 2) or would require extra curves to fit the crease. Of course a pressure distributor 2 having further curves would be more expensive to manufacture and would be less versatile in that it would not fit to such a wide variety of nose shapes and sizes.

The user-facing surface of the pressure distributor 2 may have an area of at least 250 mm2, or optionally at least 500 mm2. By providing that the user-facing surface of the pressure distributor 2 may have an area of at least 250 mm2, the pressure exerted by the face mask 20 is distributed over an area of at least 250 mm2. The user-facing surface of the pressure distributor 2 may have an area of at most 900 mm2. By providing that the user-facing surface of the pressure distributor 2 has an area of at most 900 mm2, the nose protector 10 is suitable for fitting to a wider variety of shapes of nose.

The nose protector 10 may have a maximum thickness of at most 5 mm. As explained in further detail below, the nose protector 10 can optionally comprise additional layers in addition to the pressure distributor 2. The thickness of the nose protector 10 as a whole may be at most 5 mm. Accordingly, the nose protector 10 does not cause pressure leaks between the face mask 20 and the face of the user. The thickness of the nose protector 10 as a whole may be at most 2 mm, or 1 mm.

As depicted in Figure 4, the pressure distributor 2 may comprise a central curved region 31. The central curved region 31 is for fitting snugly around the nasal ridge. The central curved region 31 may have a radius of curvature of at most 20 mm. For example, the radius of curvature of the central curved region 31 of the pressure distributor 2 may be about 10 mm. By providing that the radius of curvature is at most 20 mm, the central curved region 31 has greater rigidity, which enhances the performance of the pressure distributor 2 in distributing pressure through the material. In general, the greater the curvature of the central curved region 31, the more rigid the spine becomes which enhances the pressure distribution qualities of the material from which the pressure distributor 2 is made.

As shown in Figure 4, the pressure distributor 2 may comprise lateral regions 32. The lateral regions 32 are positioned on either side of the central curved region 31. The lateral regions 32 are contiguous with the central curved region 31. The lateral regions 32 are for fitting snugly to the nasal bridge on either side of the nasal ridge. Accordingly, the pressure distributor 2 is configured to distribute pressure both along the nasal ridge and also widthways across the width of the nasal bridge. This allows the pressure to be distributed over a larger area, thus reducing any pressure peaks on the nasal bridge.

The lateral regions 32 may be substantially flat when the nasal protector 10 is not in use. Alternatively, the lateral regions 32 may be curved, having a larger radius of curvature (i.e. being less curved) than the radius of curvature of the central curved region 31. When the nose protector 10 is being worn by the user, the exact shapes of the central curved region 31 and the lateral regions 32 may change slightly as the pressure distributor 2 conforms to the contours of the particular nasal bridge of the user. However, the pressure distributor 2 maintains its rigidity so that it can effectively distribute the pressure. The pressure distributor 2 may be flexible for fitting to contours of nasal bridges of different sizes and shapes.

The pressure distributor 2 may be formed from a material selected from the group consisting of polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP) and polyvinylchloride (PVC). Of these materials, PET is preferred. This type of material allows for the flexibility around the bridge of the nose (dependent on nose size and shape) whilst still maintaining the curved structure that provides the pressure distributor 2 with its effective pressure distribution properties.

The pressure distributor 2 may be formed from a material that is hypoallergenic, silicone and latex free. The material may be a medical grade material.

The nose protector 10 may comprise a compressible pad 3, as shown in Figure 5. The compressible pad 3 may be configured to improve the fit between the pressure distributor 2 and the nasal bridge when the nose protector 10 is worn. In particular, the compressible pad 3 may reduce the possibility of any gaps forming between the pressure distributor 2 and the nasal bridge through which gases may flow. Accordingly, the compressible pad 3 may improve the seal at the interface between the face mask 20 and the face, thereby reducing the need to tighten the mask straps further.

The compressible pad 3 may have a thickness that decreases from its central line. The central line of the compressible pad 3 contacts the nasal ridge in use, i .e. when the nose protector 10 is worn by the user. The thickness of the compressible pad 3 may decrease from the central line to lateral edges of the compressible pad 3. The lateral edges contact the nasal bridge on either side of the nasal ridge when the nose protector 10 is worn by the user. The varying thickness of the compressible pad 3 is shown in Figure 5.

The compressible pad 3 is for the purpose of improving fit over any bony prominences and to improve the fit to reduce pressure/oxygen leak.

The compressible pad 3 may have a maximum uncompressed thickness of at most 3 mm. Hence, the depth range of the compressible pad may be zero at the edge to a maximum of at most 3 mm at the central line when it is not compressed. The maximum thickness of the uncompressed compressible pad 3 may be 2 mm, or 1 mm.

The compressible pad 3 may be formed from a gel or a foam. For example, the compressible pad 3 may be formed from a gel polymer. The compressible pad 3 may be in direct contact with the nasal bridge itself. The compressible pad 3 may be placed between the nose and the pressure distributor 2. The compressible pad 3 may be a gelatinous polymeric composition or a gelatinous elastomeric composition, for example.

In use, the compressible pad 3 compresses due to pressure of the face mask 10 on the nasal bridge. Accordingly, the thickness of the compressible pad 3 in use may be less than the thickness of the compressible pad 3 when the nose protector 10 is not in use. The width and length dimensions of the compressible pad 3 may be similar or the same as those of the pressure distributor 2.

The compressible pad 3 may carry on at least part of one of its surfaces a pressure-sensitive adhesive. The compressible pad 3 may comprise a structural layer carrying on at least part of one side of it a hydrophobic gel and carrying on at least part of the other side of it the pressure-sensitive adhesive. The hydrophobic gel may be a silicone gel. The structural layer may be a film of a synthetic plastics material, such as polyurethane.

The nose protector 10 may comprise an adhesive section 1, as shown in Figures 1 to 5. The adhesive section 1 is configured to adhere the pressure distributor 2 to the nasal bridge.

The adhesive section 1 may comprise a low-tack adhesive fabric section. The adhesive section 1 is for holding the pressure distributor 2 in situ. As shown in Figure 4, the adhesive section 1 may comprise right and left opposing lateral wings. The lateral wings extend beyond the width of the pressure distributor 2.

The adhesive section 1 may have a width of at least 50 mm. The width direction corresponds to the direction perpendicular to the nasal ridge. The length direction corresponds to the direction of the nasal ridge. By providing that the width of the adhesive section 1 is at least 50 mm, the pressure distributor 2 can be held firmly in place, even when a low-tack adhesive is used. The adhesive section may have a width of at most 80 mm. By providing that the width of the adhesive section 1 is at most 80 mm, the nose protector 10 is easy for the user to wear.

The adhesive section 1 may have a length of at least 30 mm. By providing that the length of the adhesive section 1 is at least 30 mm, the pressure can be distributed over a large enough area that the overall pressure on the tissue can be reduced to a level at which the risk of a pressure ulcer forming is acceptably small or at which an established pressure ulcer can heal. The adhesive section 1 may have a length of at most 45 mm. By providing that the length of the adhesive section 1 is at most 45 mm, the nose protector 10 does not obstruct the vision or breathing of the user.

Of course, the length and width of the nose protector 10 (and hence the adhesive section 1) can be varied depending on the size of the nasal bridge of the user. As depicted in Figure 4, the adhesive section 1 may have a length that decreases with distance away from the pressure distributor 2. The adhesive section 1 may be generally rectangular, having a greater width than length.

The adhesive section 1 may have a maximum thickness of at most 1 mm. As shown in Figure 5, the adhesive section 1 may have a substantially uniform thickness across its width and length. By providing that the thickness of the adhesive section 1 is at most 1 mm, the possibility of changes in pressure leak or oxygen levels is reduced. Accordingly, the effectiveness of any medical therapy is not changed by use of the adhesive section 1. The thickness of the adhesive section may be at most 0.5 mm. The thickness of the adhesive section may be at least 0.1 mm. By providing that the thickness of the adhesive section 1 is at least 0.1 mm, the adhesive section may be tear-resistant and may be able to be stretched. The adhesion section may be soft, and tear-resistant as well as being able to be stretched.

The adhesive section 1 may have a low-tack adhesive on the side in contact with the skin of the user. The adhesive section may have a soft material on the side in contact with the surface of the face mask 20.

The adhesive section 1 may comprise a releasably adhesive tape. The adhesive section 1 may comprise a structural layer comprising a synthetic material in the form of a film or non-woven web. The structural layer of the adhesive section 1 may carry on at least one part of one side of it a hydrophobic gel and on at least part of the other side of it a backing layer.

The hydrophobic gel that is carried on one side of the structural layer may be a soft silicone.

As shown in Figure 5, the adhesive section 1 may be provided between the pressure distributor 2 and the nasal bridge, in use. However, this is not necessarily the case. The adhesive section 1 may be provided such that the pressure distributor 2 is fixed between the adhesive section 1 and the nasal bridge in use.

As shown in Figure 5, the nose protector 10 may comprise a series of layers in this order from the nasal bridge to the face mask 20: a compressible pad 3, an adhesive section 1 and a pressure distributor 2.

As shown in Figure 1, the adhesive section 1 may be used to adhere the pressure distributor 2 to the nasal bridge of the user’s face. Alternatively, the adhesive section 1 may be used to adhere the pressure distributor 2 to the face mask 20. As a further alternative, the adhesive section 1 may be used to adhere the pressure distributor 2 to both the face mask 20 and the nasal bridge of the user, as shown in Figure 2.

Figure 2 shows a face mask 20 that includes a rim 21. The rim 21 forms an interface between the face mask 20 and the face of the user. The type of mask shown in Figure 2 is the full face mask type that fits over both the nose and mouth. The present invention is equally applicable to the nasal mask type that fits over only the nose of the user.

In use, the face mask 20 applies pressure to the face via the rim 21. The interface point 22 shown in Figure 2 is a position at which a particularly high pressure can be exerted on the nasal bridge of the user.

The nose protector 10 of the present invention provides an improvement over known devices. Known devices that aim to help with face mask fit and that aim to reduce pressure can be thick gel or gel-like materials. These still allow for a pressure point to be transmitted to the skin below (such that pressure ulcers can be formed). Furthermore, the thickness of the gel can also affect the fit of the mask so that pressure leaks can occur at the edge of the device.

As explained above, the nose protector 10 may be adapted for use with a face mask 20. Alternatively, the nose protector 10 may be fixedly attached to the face mask 20. The nose protector 10 may be fixedly attached to a rim 21 of the face mask 20, as shown in Figure 2. The nose protector 10 may be manufactured together with the face mask 20.

Claims (22)

Claims
1. A nose protector for a face mask worn by a user, the nose protector comprising: a pressure distributor having a curved shape configured to fit snugly to the user’s nasal bridge, wherein the pressure distributor maintains its curved shape such that it has rigidity so as to distribute pressure from an interface point between the face mask and the nasal bridge along the user’s nasal ridge corresponding to where the pressure distributor is fitted.
2. The nose protector of claim 1, wherein the pressure distributor is formed of a single piece of material.
3. The nose protector of any preceding claim, wherein the pressure distributor has a maximum thickness of at most 1mm.
4. The nose protector of any preceding claim, wherein the pressure distributor has an area of at least 250 mm2 to contact the nasal bridge, in use.
5. The nose protector of any preceding claim, wherein the pressure distributor is a separate component from the face mask.
6. The nose protector of any preceding claim, wherein the nose protector is detachably connectable to the face mask and/or to the nasal bridge.
7. The nose protector of any preceding claim, wherein the pressure distributor is sized to extend at least 25mm along the user’s nasal ridge.
8. The nose protector of any preceding claim, wherein the nose protector has a maximum thickness of at most 5mm.
9. The nose protector of any preceding claim, wherein the pressure distributor comprises a central curved region for fitting snugly around the nasal ridge, wherein the central curved region has a radius of curvature of at most 20mm.
10. The nose protector of any preceding claim, wherein the pressure distributor comprises lateral regions, on either side of the central curved region, for fitting snugly to the nasal bridge on either side of the nasal ridge.
11. The nose protector of claim 10, wherein the lateral regions are substantially flat when the nose protector is not in use.
12. The nose protector of any preceding claim, wherein the pressure distributor is flexible for fitting to contours of nasal bridges of different sizes and shapes.
13. The nose protector of any preceding claim, wherein the pressure distributor is formed from a material selected from the group consisting of polyethylene terephthalate, polyethylene, polypropylene and polyvinyl chloride.
14. The nose protector of any preceding claim, comprising: a compressible pad configured to improve the fit between the pressure distributor and the nasal bridge when the nose protector is worn.
15. The nose protector of claim 14, wherein the compressible pad has a thickness that decreases from a central line that, in use, contacts the nasal ridge to lateral edges of the compressible pad that, in use, contact the nasal bridge on either side of the nasal ridge.
16. The nose protector of any of claims 14 and 15, wherein the compressible pad has a maximum uncompressed thickness of at most 3mm.
17. The nose protector of any of claims 14 to 16, wherein the compressible pad is formed from a gel or a foam.
18. The nose protector of any preceding claim, comprising: an adhesive section configured to adhere the pressure distributor to the nasal bridge.
19. The nose protector of claim 18, wherein the adhesive section extends laterally beyond the pressure distributor for adhering to the user’s cheeks.
20. The nose protector of any of claims 18 and 19, wherein the adhesive section has a maximum thickness of at most 1mm.
21. A combination of a face mask and the nose protector of any preceding claim.
22. A nose protector substantially as hereinbefore described with reference to the accompanying drawings.
GB201518373A 2015-10-16 2015-10-16 Nose Protector for a face mask Active GB2543360B (en)

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GB201518373A GB2543360B (en) 2015-10-16 2015-10-16 Nose Protector for a face mask
PCT/GB2016/053194 WO2017064507A1 (en) 2015-10-16 2016-10-14 Nose protector for a face mask

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GB2543360A true true GB2543360A (en) 2017-04-19
GB2543360B GB2543360B (en) 2017-10-04

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2931356A (en) * 1958-08-25 1960-04-05 Puritan Compressed Gas Corp Oxygen mask having detachable face seal cushion
US20090223522A1 (en) * 2008-03-07 2009-09-10 Johnny Hernandez Apparatus and method for cushioning a ventilation mask
US20100018535A1 (en) * 2008-07-24 2010-01-28 Chi-San, LLC Gel cushion pad for mask
US20110209701A1 (en) * 2010-03-01 2011-09-01 Laura Derringer Nose pad cushion and applicator for respiratory mask
US20120204881A1 (en) * 2011-02-09 2012-08-16 Resmed Limited Pad for a mask
US20150250972A1 (en) * 2012-09-21 2015-09-10 Koninklijke Philips N.V. Respiratory mask having a magnetically supported cushion

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3594813A (en) * 1968-07-10 1971-07-27 Roger S Sanderson Protective device
US4274402A (en) * 1979-05-03 1981-06-23 The Denver Splint Company Nose splint
US9901699B2 (en) * 2008-06-04 2018-02-27 Resmed Limited Pad for a mask
US20120067350A1 (en) * 2010-09-17 2012-03-22 Palmer Jr Melvin Nasal Soft CPAP Cushion

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2931356A (en) * 1958-08-25 1960-04-05 Puritan Compressed Gas Corp Oxygen mask having detachable face seal cushion
US20090223522A1 (en) * 2008-03-07 2009-09-10 Johnny Hernandez Apparatus and method for cushioning a ventilation mask
US20100018535A1 (en) * 2008-07-24 2010-01-28 Chi-San, LLC Gel cushion pad for mask
US20110209701A1 (en) * 2010-03-01 2011-09-01 Laura Derringer Nose pad cushion and applicator for respiratory mask
US20120204881A1 (en) * 2011-02-09 2012-08-16 Resmed Limited Pad for a mask
US20150250972A1 (en) * 2012-09-21 2015-09-10 Koninklijke Philips N.V. Respiratory mask having a magnetically supported cushion

Also Published As

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WO2017064507A1 (en) 2017-04-20 application
GB201518373D0 (en) 2015-12-02 grant
GB2543360B (en) 2017-10-04 grant

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