Protective Apparatus Field of Invention

The present invention relates to protective apparatus, particularly to protective apparatus for protecting a newborn baby from externally generated noise. Background to the Invention

Exposure to high levels of noise can be extremely stressful for newborn babies, particularly premature babies. A build up of stress can in turn reduce the level of oxygen reaching the baby's brain. Stress and decreased oxygen levels have associated health risks including increased rate of calorie burn and, in extreme cases, death. Research has also shown that babies who have spent time in a Neonatal

Intensive Care Unit are over 10 times more likely to suffer from hearing impairments compared to those who have not. This loss of hearing may, at least in part, be attributable to exposure to noise.

Newborn babies can be exposed to high levels of noise in the early days of their life. For example, the baby may need to be moved between hospitals urgently in a transport incubator by helicopter, fixed wing aircraft or ambulance, or part of the baby's treatment may involve exposure to noise generating equipment such as an incubator or an MRI scanner. Situations such as these can expose the child to noise levels up to 120 dB(A). A baby is very susceptible to noise because sound can attenuate through a newborn baby's skull, particularly through un-fused portions of the baby's skull called fontanelles, as well as through the baby's ear canals.

US 5243709 describes an earmuff which attaches to the skin around an infant's ear. The earmuff contains sound attenuating layers of foam. These earmuffs have drawbacks, for example, the earmuffs are secured to the infant by an adhesive film and, once attached, the earmuffs can be difficult to remove without damaging the infant's skin and the sound reduction realisable may not be sufficient to protect an infant from extremely loud noises, such as vehicle noise. Summary of Invention According to a first aspect of the present invention there is provided a protective apparatus for a baby, the protective apparatus comprising: a protective covering adapted to cover at least part of a baby's cranium for, in use, protecting the at least part of the baby's cranium from externally generated noise.

For the avoidance of doubt, the cranium is the part of the skull which covers the brain. The protective apparatus provides acoustic protection for at least part of a baby's cranium. The cranium, particularly the fontanelles between the baby's skull plates, can absorb sound potentially causing the baby distress. In addition, such a covering still permits access to a baby's face in the event of an emergency and permits observation of the baby. Furthermore, the open face will not restrict the use of other care giving equipment such as vent tubes and only partially covering the cranium reduces the possibility of the covering causing the baby to overheat.

Preferably, the protective covering is adapted to additionally cover the baby's ears. Additionally covering the baby's ears protects the main regions of the baby's skull which can absorb sound, that is the ears and fontanelles.

Preferably, the protective covering can be manipulated between an open configuration, in which the baby can be positioned in the protective covering, and a closed configuration, in which at least part of the baby's cranium is covered. Alternatively, the protective covering comprises a tubular portion adapted to be slipped over a baby's head.

In the closed configuration the protective covering may form a shell.

Preferably, the shell is substantially rigid. A rigid shell can provide impact resistance as well as acoustic resistance. Alternatively, the shell is at least partially flexible.

In a further alternative, the protective covering is at least partially flexible.

In one embodiment, the protective covering is substantially flexible.

Preferably, the protective covering is adapted to prevent a build up of heat. It is not desirable for a baby to become overheated. Preferably, the protective covering comprises a soft material.

The soft material may be a natural fabric. The natural fabric may be cotton. The protective covering may comprise a breathable material. Alternatively or additionally, the protective covering comprises an elastic material. An elastic material can ensure a snug fit to the baby's cranium. A balance needs to be struck between a snug fit and the exertion of pressure on the baby's cranium which can cause the baby distress. Too much pressure can distort and change the shape of the baby's skull.

In one embodiment the protective covering comprises a soft, elastic material.

The protective covering may include vibration absorbing material. Utilising vibration absorbing material, for example silicon, can provide further protection to the baby from externally generated vibrations and noise generated by resonance of the protective covering. In an alternative embodiment, the protective covering is polymeric.

Polymeric materials are preferable because, generally, they are relatively easy to process and are lightweight.

Most preferably, the protective covering is polypropylene.

Alternatively, the protective covering is elastomeric. For example, a rubber. Preferably, the protective covering comprises a cranium covering portion for covering at least part of the baby's cranium.

Preferably, the protective covering further comprises first and second ear covering portions.

In one embodiment, the cranium covering portion comprises a band. Preferably, the band is adapted to encircle a baby's head.

Most preferably, the band is adapted to encircle the baby's forehead, the sides of the baby's head and the nape of the baby's neck

. In such an arrangement, when in use, the top of the baby's head may be exposed. Preferably, the band defines a pair of apertures, each aperture adapted to receive a baby's ear. Apertures are provided to prevent the baby's ear becoming trapped or injured as the band is fitted or removed.

In one arrangement, the band can be manipulated between an open configuration, in which the baby can be positioned in the protective covering, and a closed configuration, in which at least part of the baby's cranium is covered. A fold flat type configuration causes minimum disruption to the infant and is easiest for a nurse to fit.

Preferably, in this arrangement, the band comprises a first end and a second end. Preferably, one of the first or second ends can be fastened to the protective covering at or adjacent the other of the first or second ends to form the band.

Alternatively or additionally, one of the first or second end can be attached to the other of the first or second ends.

Preferably, one of the first or second ends can be releasably fastened to the protective covering.

The band is most preferably fastened over the baby's forehead.

Preferably, the protective covering comprises an upper cranium covering portion adapted to cover at least part of the top or crown of a baby's head.

Preferably, the upper cranium covering portion is releasably mounted to the band. A crown covering portion can allow the heat to build up causing the baby some distress, releasably attaching the crown covering portion permits it to be used for short bursts, only when required, for example during an MRI scan. Additionally or alternatively, the upper cranium covering portion is pivotally mounted to the band.

Preferably, the upper cranium covering portion is hingedly mounted to the band.

Preferably, the upper cranium covering portion is adapted to cover only part of the upper cranium.

The upper cranium covering portion may be include vents. Vents can prevent the build up of heat.

Preferably, the edges of the vents include a seal to prevent the ingress of noise.

The upper cranium covering portion may be strap. In one arrangement, where the protective apparatus is a band, the upper cranium covering portion extends from a first section of the protective covering adjacent the baby's neck to a second section of the protective covering adjacent the baby's forehead, the upper cranium covering portion passing over or adjacent the crown of the baby's head. Such an arrangement prevents the band slipping over the baby's eyes and maintains the position of the and with respect to the baby's ears.

Preferably, in this arrangement the upper cranium covering portion releasably attaches to the protective covering second section.

In an alternative embodiment, the cranium covering portion comprises a front cranium covering portion and a rear cranium covering portion. Preferably, the front cranium covering portion is moveable with respect to the rear cranium covering portion.

Preferably, the front cranium covering portion is moveable between a first position in which, in use, the top of a baby's head is exposed, to a second position in which the top of the baby's head is covered.

Preferably, the front cranium covering portion is releasably mounted to the rear cranium covering portion.

Additionally or alternatively, the front cranium covering portion is pivotally mounted to the rear cranium covering portion. Preferably, the front cranium covering portion is hingedly mounted to the rear cranium covering portion.

The front cranium covering portion may be hingedly mounted to the rear cranium covering portion by a pin hinge. A pin hinge provides an attachment which can be easily disassembled for cleaning. Alternatively, the front cranium covering portion may be hingedly mounted to the rear cranium covering portion by a living hinge. In this context, a living hinge is a twisting, bending and/or stretching section. A living hinge is useful because the interfaces of a conventional hinge can house germs.

In a further alternative, the front cranium covering portion is slidably mounted to the rear cranium covering portion.

Preferably, each ear covering portion is moveable with respect to the cranium covering portion. In one embodiment, each ear covering portion is moveable with respect to the rear cranium covering portion.

Preferably, each ear covering portion is moveable between a first position in which, in use, a baby's ear is exposed, to a second position in which the baby's ear is covered.

Each ear covering portion may be pivotally mounted to the cranium covering portion.

Each ear covering portion may be hingedly mounted to the cranium covering portion by a pin hinge.

Alternatively, each ear covering portion may be hingedly mounted to the cranium covering portion by a living hinge.

Preferably, where pin hinges are used, the front cranium covering portion and/or the ear covering portions are releasably hingedly mounted to the rear cranium covering portion.

Preferably, the protective covering is in the open configuration when the front cranium covering portion and/or the ear covering portions are in their respective first positions.

Preferably, the protective covering is in the closed configuration when the front cranium covering portion and/or the ear covering portions are in their respective second positions in which at least part of the baby's cranium and/or ears are covered.

In one embodiment, each ear covering portion is attachable to the protective covering.

Preferably, each ear covering portion is releasably attachable to the protective covering.

Preferably, the protective covering comprises a pair of supports, each support adapted to receive an ear covering portion. Preferably, each support is attached to the edge of one of the apertures defined by the band.

The ear covering portions may be attachable to the supports by a threaded connection.

Alternatively, the ear covering portions are attachable by a bayonet, interference or similar releasable fitting. It is important that the method of attaching the ear covering portions is chosen bearing in mind that minimal pressure should be applied to the baby's skull during attachment. Preferably, the ear covering portions are releasably securable to the cranium covering portion ¹ .

In one embodiment, the ear covering portions are releasably securable by a snap fit fastening.

Preferably, the ear covering portions are releasably securable to the cranium covering portion. Particularly, the ear covering portions are releasably securable to the front cranium covering portion when said ear and front cranium covering portions are in their respective second positions. - In an alternative embodiment, the ear covering portions are attached to the upper cranium covering portion and releasably attached to the supports.

Preferably, each ear covering portion, each ear covering support and/or the cranium covering portion is adapted to engage a baby's skull.

Each ear covering portion, each ear covering support and/or the cranium covering portion may be adapted to be secured to the baby's skull. An adhesive may be used to secure each ear covering portion and/or the cranium covering portion to the baby's skull

Most preferably, the protective covering comprises an engaging member adapted to engage the skin surrounding a baby's ear.

Alternatively or additionally, each ear covering portion, each ear covering support and/or the cranium covering portion comprises an engaging member adapted to engage the skin surrounding a baby's ear. Preferably, the engaging member is a seal adapted to engage the baby's skin. Preferably, the seal is adapted to form an acoustic seal against the baby's skin.

Preferably, the Seal is maintained by the application of pressure. Having the seal maintained by the application of pressure avoids the need for adhesives to be used which may damage an infant's skin. Adhesives or other fixing means could be used, however, to maintain the seal. Preferably, the engaging member is a foam. Foams, particularly soft foams are preferred because they are non-abrasive, minimising the possibility of damaging an infant's skin.

Preferably, the foam is a closed cell foam. A closed cell foam is preferred because the closed cell structure is resistant to the ingress of infections, and easily wiped clean.

Alternatively, the foam is an open cell noise attenuating foam. Preferably, the foam comprises a breathable fabric covering. The engaging member may be adapted to be replaced. Alternatively, the engaging member comprises a replaceable surface portion. Hygiene is a vital consideration where newborn babies are concerned. Being able to replace the engaging member, or providing a replaceable member surface, assists the user in maintaining the level of hygiene.

Preferably, the protective covering comprises inflation apparatus adapted, upon inflation, to move the engaging member into engagement with the baby's skull. Preferably, the engaging member is biased such that when pressure applied by the inflation apparatus is removed, the engaging member, in use, moves away from the baby's skin.

Preferably, the inflation apparatus is adapted to be inflated to a selectable predetermined pressure. It is desirable to be able to set a maximum inflation pressure. Such a maximum inflation pressure may, for example, be the baby's blood pressure.

Ideally the inflation pressure should be below the baby's blood pressure to prevent clotting. Because of the fragile nature of a baby's, particularly a neonate's, skin, the maximum pressure applied by the seal to the baby's skin should be as low as is possible whilst still providing an adequate seal.

Preferably, the inflation apparatus includes feedback means for adjusting the inflation pressure automatically. The feedback means may, for example, monitoring the baby's blood pressure.

Preferably, the inflation apparatus includes a vent or pressure relief valve to prevent inflation of the inflation apparatus above the pre-determined pressure.

Preferably, the inflation apparatus is manually controlled.

Alternatively, the inflation apparatus is electrically or electro-mechanically controlled.

The inflation apparatus may be adapted to be inflated by gas and/or liquid. Preferably, each ear covering portion comprises noise absorbing material.

Noise absorbing materials, or passive noise reduction materials are useful for insulating against high frequency sounds.

Preferably, the noise absorbing material is at least one layer of foam.

The noise absorbing material may be a plurality of layers of foam. The noise absorbing material may define a noise absorbing shape. For example, where the noise absorbing material is a foam, the surface may be non-linear, for example contoured.

The plurality of layers of foam may be arranged in a sandwich construction.

The noise absorbing material may comprise a plurality of different foams. The foams may have different densities or thicknesses.

The noise absorbing material may further comprise air pockets.

Preferably, the foam is acoustic foam.

Preferably, the acoustic foam is expanded polyurethane acoustic foam.

Preferably, the protective apparatus is provided with a plurality of different ear covering portions, each ear covering portion providing a different level of acoustic protection. In some circumstances, such as in a ward, a reduced level of acoustic protection is acceptable or, indeed, desirable to allow the baby to hear, for example his mothers voice. In other environments, such as in a helicopter a higher level of acoustic protection is necessary. In some cases the higher level of acoustic protection ear covering portions will be thicker than the reduced level ear covering portions. In such a case the baby will have reduced side-to-side mobility of its head wearing the thicker ear covering portions. In certain circumstances this may be undesirable. During an MRI scan the baby's head is restrained in a vertical plane. The ear covering portions may be adapted to assist in maintaining the baby's head in the vertical plane.

Additionally or alternatively, each ear covering portion comprises active noise cancellation or reduction apparatus. Active noise cancellation or reduction apparatus reduces low to medium frequencies by electronically reprocessing a noise signal to generate a cancelling disturbance or "anti-noise". Preferably, the noise cancelling or reduction apparatus is adapted to cancel or reduce an externally generated noise by destructive interference. Destructive interference occurs when the high-pressure part of one wave meets the low pressure part of another to remove the pressure and the generated noise.

Additionally or alternatively, the noise cancelling or reduction apparatus is adapted to cancel or reduce an externally generated noise by impedance coupling. With impedance coupling a sound wave is generated and used to "push" against another sound wave.

In one embodiment the noise cancelling or reduction apparatus is releasably attachable to the supports. Preferably, each ear covering portion includes an interface adapted, in use, to be arranged between the baby's ear and the noise cancelling or reduction apparatus and the noise absorbing material.

Preferably, the interface is replaceable. A sterile replaceable interface can be provided to reduce the possibility of infection. Alternatively, the interface is a cleanable. A wipe clean material may be used.

Preferably, at least part of the cranium covering portion includes lifting apparatus to lift a baby's head.

Preferably, at least part of the cranium covering portion is inflatable.

Preferably, at least part of the cranium covering portion is inflated by gas or liquid.

Preferably, the cranium covering portion includes an inflatable pad. An inflatable pad permits, in use, a baby's head to be lifted into correct alignment with the ear covering portions.

Preferably, the inflatable pad is adapted, in use, to centre a baby's head. Most preferably, the inflatable pad defines a ring. A ring or doughnut shaped pad assists in centring and maintaining the position of the baby's head.

Preferably, the protective covering defines a ring to assist on centring and maintaining the position of the baby's head.

Preferably, the protective covering is adapted to interact with a medical device to a assist the positioning of the medical device. The term "medical device" is intended to include feeding tubes, skin probes, vein probes, medication administration tubes etc. A newborn baby often requires to be fed liquids or gases through a tube. Preferably, the protective covering is adapted to support the medical device.

In one embodiment, attachment means are provided to support the medical device.

The attachment means may be provided on an external surface of the protective covering. Alternatively, or additionally, the attachment means may be provided on an internal surface of the protective covering.

The attachment means may comprise a mechanism for securing the medical device with respect to the protective covering.

The attachment means may be at least partially releasably attachable to the protective covering. Preferably, the attachment means is adapted to be tightened around the medical device to secure the medical device with respect to the protective covering.

The attachment means may be at least one flap.

The at least one flap may be fixedly attached at one end to the protective covering and releasably attachable at the other. Alternatively, the at least one flap may be releasably attachable to the protective covering at both ends of the at least one flap.

There may be a plurality of flaps at various locations around the protective covering.

Alternatively or additionally, the attachment means comprises at least one fixing point to which a medical device may be attached.

Each fixing point may be a clip adapted to receive a medical device.

Alternatively or additionally, each fixing point may be one part of a connector adapted to receive a complementary part of the connector attached to the medical device. The connector may be a hook and loop type connector such as Velcro.

Alternatively, the medical device may be fixed to the protective covering by some other means such as adhesive.

Alternatively or additionally, the protective covering is adapted to receive the medical device, in use between the covering and the baby.

W

In this embodiment, cushioning means may be provided to protect, in use, the baby's skin.

Preferably, the protective covering defines a channel adapted to receive a supply tube such as a ventilator gas tube. Providing a channel on the covering ensures 5 the tube can be positioned easily with respect to the baby.

Preferably, the channel includes securing apparatus to secure a supply tube to the covering.

Preferably, the channel is adapted to support the weight of a supply tube.

Preferably, the channel is defined by the front cranium covering portion. 0 Preferably, the front cranium covering portion includes a forehead seal adapted to seal against a baby's forehead.

Preferably, the covering comprises a cooling apparatus adapted to cool at least part of the baby's cranium and/or ears. Depending on the environmental circumstances the baby may tend to overheat. Providing cooling apparatus to cool at 5 least part of the baby's cranium can help prevent this. Furtherjnore, providing the facility to cool the baby has been shown to be advantageous for certain types of treatment.

Preferably, the cooling apparatus includes a conduit for the circulation or flow of a cooling medium. 0 Preferably, the protective covering includes temperature monitoring apparatus for monitoring the temperature of the baby within the protective covering.

Preferably, the temperature monitoring apparatus is control the cooling apparatus. The cooling apparatus can be automated by providing a temperature monitoring apparatus which controls the temperature of the cooling apparatus within parameters set by a user.

The cooling apparatus may provide cooling by the circulation of a fluid. Most preferably, the fluid is cooled gas or liquid.

Preferably, the protective covering is at least partially lined. A lining may be provided to provide warmth and comfort for the infant. The lining may be thermally insulating. A thermally insulating lining helps reduce the loss of heat through the baby's cranium. The lining may include a heat pad.

Preferably, the protective covering is at least partially lined with a noise absorbing material.

The noise absorbing material maybe layered.

The noise absorbing material may be a plurality of layers of foam.

The noise absorbing material may define a noise absorbing shape. For example, where the noise absorbing material is a foam, the surface may be non-linear, for example contoured. The plurality of layers of foam may be arranged in a sandwich construction.

The noise absorbing material may comprise a plurality of different foams.

The foams may have different densities or thicknesses.

The noise absorbing material may further comprise air pockets.

Preferably, the foam is acoustic foam. Preferably, the acoustic foam is expanded polyurethane acoustic foam.

Preferably, the lining is movable with respect to the protective covering.

Preferably, the protective covering includes curved externally facing surfaces. Whilst not wishing to be bound by theory, it is believed curved surfaces are better at reflecting sounds than non-curved surfaces. Additionally curved surfaces are less susceptible to resonating than flat surfaces due to their structural integrity.

Preferably, the protective apparatus further comprises a visor for protecting the baby's eyes. It may be desirable to protect the baby's eyes during, for example, phototherapy. Similarly a visor can be used to simulate night time which may be useful during the baby's developmental care. Preferably, the visor is releasably attachable to the protective covering.

Alternatively, the visor is fixedly attachable to the protective covering.

Preferably, the visor is moveable between a first position iri which the baby's eyes are covered and a second position in which the baby's eyes are uncovered.

Preferably, the visor is hingedly attached/attachable to the protective covering. According to a second aspect of the present invention there is provided a support apparatus for use with the protective apparatus of the first aspect, the support apparatus comprising: a mattress; and an inflatable pillow. Providing an inflatable pillow permits the pillow to be inflated to raise an infant's head such that the infant's spine is maintained in a preferred position and the neck is prevented from flexing. For example it will generally be desirable to align keep the infant's spine straight by aligning the infant's head with the infant's body.

Preferably, the pillow is adapted to maintain the infant's head in more than one orientation. Generally it will be desired to have the baby's head in one of three positions; either with the back of the head engaging the pillow, ^' or one of the sides of the head engaging the pillow. The pillow provides support for the baby's head in any of these orientations.

Preferably, the mattress and/or the pillow is adapted to absorb vibrations.

Preferably, the mattress and/or the pillow is adapted to provide thermal insulation.

Preferably, the mattress and pillow are separate. Alternatively, the mattress and pillow are unitary.

The pillow may be releasably securable to the mattress.

Preferably, the mattress comprises a foam.

Preferably, the foam is a closed cell foam.

Most preferably, the foam is a closed cell polyethylene foam. Preferably, the mattress includes a pillow support portion for supporting the pillow.

Preferably, the pillow support portion is in a different plane to the rest of the mattress.

Preferably, the mattress comprises a non-slip covering. Preferably, the pillow is manually inflated. Alternatively, the pillow is electrically or electro-mechanically inflated.

According to a third aspect of the present invention there is provided a system for protecting a baby's ears and cranium from externally generated noise, the system comprising: a protective covering adapted to cover at least part of a baby's cranium, and a support apparatus comprising a mattress and an inflatable pillow.

According to a fourth aspect of the present invention there is provided a protective apparatus for a baby, the protective apparatus comprising: a protective covering adapted to cover a baby's ears, and active and passive noise reduction means; wherein, in use, the protective apparatus protects the baby's ears from externally generated noise.

According to a fifth aspect of the present invention there is provided a medical device support apparatus for a baby, the apparatus comprising:

a band adapted to encircle a baby's head, the band adapted to cover the baby's forehead, the sides of the baby's head and the nape of the baby's neck.

Preferably, the band is adapted to support the medical device.

In one embodiment, attachment means are provided to support the medical device.

The attachment means may be provided on an external surface of the protective covering. Alternatively, or additionally, the attachment means may be provided on an internal surface of the band.

The attachment means may comprise a mechanism for securing the medical device with respect to the band.

The attachment means may be at least partially releasably attachable to the band.

Preferably, the attachment means is adapted to be tightened around the medical device to secure the medical device with respect to the band. The attachment means may be at least one flap.

The at least one flap may be fixedly attached at one end to the band and releasably attachable at the other.

Alternatively, the at least one flap may be releasably attachable to the band at both ends of the at least one flap. There may be a plurality of flaps at various locations around the band.

Alternatively or additionally, the band comprises at least one fixing point to which a medical device may be attached.

Each fixing point may be a clip adapted to receive a medical device.

Alternatively or additionally, each fixing point may be one part of a connector adapted to receive a complementary part of the connector attached to the medical device.

The connector may be a hook and loop type connector such as Velcro. Alternatively, the medical device may be fixed to the band by some other means such as adhesive. In another embodiment, the band is adapted to receive the medical device, in use between the covering and the baby.

In this embodiment, cushioning means may be provided to protect, in use, the baby's skin.

According to a sixth aspect of the present invention there is provided an ear covering portion for use with the protective apparatus of the first aspect.

For the avoidance of doubt, features of one aspect may also be applicable to the other aspects. Brief Description of the Drawings

Embodiments of at least one aspect of the present invention will now be described with respect to the following drawings in which:

Figure 1 is a perspective view of a system for protecting at least part of a baby's cranium from externally generated sound, according to a first embodiment of the present invention;

Figure 2 is a perspective view of the protective covering of Figure 1 in an open configuration;

Figure 3 is a perspective view of the protective covering of Figure 1 in a closed configuration; Figure 4 is a perspective view of the protective covering of Figure 1 in a closed configuration shown protecting a baby;

Figure 5 is a schematic sectional view through an ear covering portion in an un-inflated configuration;

Figure 6 is a schematic sectional view through an ear covering portion in an inflated configuration;

Figures 7 to 12 are a series of perspective views showing operation of the system;

Figure 13 is an enlarged perspective view of the user interface of Figure 1;

Figure 14 is a side view of a baby using the system of Figure 1 with the baby's head in a sideways orientation;

Figure 15 is a perspective view of a protective covering according to a second embodiment of the present invention;

Figure 16 is a perspective view of a protective covering according to a third embodiment of the present invention; Figure 17 is a perspective view of the protective covering of Figure 16 with addition of ear covering portions;

Figure 18 is a perspective view of a protective covering in a first configuration according to a fourth embodiment of the present invention;

Figure 19 is a perspective view of the protective covering of Figure 18 in a second configuration;

Figure 20 is a perspective view of a protective covering in a first configuration according to a fourth embodiment of the present invention; and Figure 21 is a perspective view of the protective covering of Figure 20 in a second configuration- Detailed Description of the Drawings

Referring firstly to Figure 1 there is shown a perspective view of a system, generally indicated by reference numeral 10 for protecting at least part of a baby's cranium from externally generated sound, according to an embodiment of the present invention.

The system 10 comprises a support mattress 12, a support pillow 14 and a protective covering 16 adapted to cover at least part of a baby's cranium. The system 10 also includes inflation pumps 18 and a user interface 19 which will be discussed in due course.

The protective covering 16 will now be described in greater detail with reference to Figures 2 to 6.

Figure 2 shows a perspective view of the protective covering 16 of Figure 1 in an open configuration. In the open configuration a baby can be positioned in the protective covering 16.

The protective covering 16 comprises a rear cranium covering portion 20, a front cranium covering portion 22 and first and second ear covering portions 24,26. The front cranium covering portion 22 is pivotally mounted to the rear cranium covering portion 20 via pivots 28a,28b. The ear covering portions 24 are pivotally mounted to the rear cranium covering portion 20 by hinges 30a,30b. The front cranium covering portion 22 and the ear covering portions 24,26 can be pivoted from the open configuration (shown in Figure 2) to a closed configuration shown in Figures 3 and 4, perspective views of the protective covering 16 of Figure 1 in a closed configuration without a baby (Figure 3) and with a baby (Figure 4). In the closed configuration, the ear covering portions 24,26 are releasably fixable to the front cranium covering portion 22 by snap fit attachments 32. Each snap fit attachment 32 comprises a female portion 32a attached to one of the ear covering portions 24,26, and a male portion 32b attached to the front cranium covering portion 22. In the closed configuration the protective covering 16 forms a

protective shell which protects the ears and cranium of the baby 5 from externally generated noise.

The front cranium covering portion 22 and the ear covering portions 24,26 are moulded from 3mm thick polypropylene. One of the ear covering portions 24 will now be described with reference to

Figure 3, and Figures 5 and 6, schematic sectional views through an ear covering portion 24 in an un-inflated configuration (Figure 5) and an inflated configuration (Figure 6).

The ear covering portion 24 comprises a pocket 34, an ear protection unit 36 housed within the pocket 34, and an inflatable bladder 38 sandwiched between the unit 36 and the pocket 34. The pocket 34 comprises two layers of polypropylene (not shown) to provide further sound insulation.

Each ear protection unit 36 comprises a unit housing 40, a piece of noise absorbing foam 42, an anti-noise speaker 44, a microphone 54, a perforated cover 55 and an annular seal 46 for forming an acoustic seal with the skin surrounding a baby's ear.

As hygiene is of paramount importance to reduce the risk of infection, the perforated cover 55 is replaceable. The perforated cover 55 can be replaced after each use of the system 10 by pulling on lifting tab 50 (also visible on Figure 3) and sliding the perforated cover 55 from behind the annular seal 46. Additionally, the annular seal 46 is formed from a section of closed cell expanded polyethylene foam, which is used because it can be easily cleaned.

The unit housing 40 is fixed to the pocket 34 by a latex membrane 48 which biases the unit 36 towards the pocket 34. The microphone 54 is housed within the anti-noise speaker 44 to maximise the efficiency of the noise cancelling provided. The noise absorbing foam 42 is expanded polyurethane acoustic foam and is adapted to filter out, in particular, high frequency sounds. The unit microphone 54 feeds the externally generated noise reaching the baby's ear back to a processing unit 62 (shown on Figure 1 and discussed later with reference to Figure 12) via wires 52 (Figures 1 and 3). The processing unit then generates anti-noise which is played through the speaker 44 and which cancels out the externally generated noise picked up by the microphone 54. This procedure of cancelling out noise is especially effective for the removal of low to mid frequency sounds.

When a baby is loaded into the protective covering 16, the ear covering portion 24 is in the un-inflated configuration shown in Figure 5. Once the ear covering portion 24 is pivoted to the position shown in Figure 3, the inflatable bladder 38 is inflated by means of an inflation pump (not shown but discussed with reference to Figure 8). As the inflatable bladder 38 is pumped up the ear protecting unit 36 is moved away from the pocket 34 towards the baby's ear (not shown). The annular seal 46 engages the skin around the baby's ear and forms an acoustic seal. A vent (not shown) is provided on the bladder 38 to prevent over inflation of the bladder 38 and unnecessary pressure being applied to the baby's skin. The vent or relief valve is adjustable to suit the baby's needs - the clamping pressure from the annular seal 46 onto the skull has to be below blood pressure to prevent blood clotting or restriction of blood flow with the subsequent possibility of the brain being starved of oxygen leading to further problems. The vent can be adjusted to prevent this.

When it is desired to remove the baby from the protective covering 16, the inflation bladder 38 is deflated and the elastomeric membrane 48 pulls the unit 36 away from the baby's skin.

Referring back to Figure 2, the rear cranium covering portion 20 includes an inflatable pad 56. . The purpose of the inflatable pad 56 is to raise the baby's head to align the baby's ears with the ear protection units 36 such that the baby's ear is wholly contained inside the annular seal 46 and the seal can engage the skin surrounding the ear. The pad 56, once inflated, is in the form of a ring. A ring shaped pad 56 helps to keep the baby's head centred in the protective covering 16 and will at least partially absorb any mechanical vibrations which may otherwise pass through the system 10 to the baby 5. The front cranium covering portion 22 includes an acoustic seal 58 along its edge. The edge seal 58 assists in preventing the sound leaking into the protective covering 16 around the edges of the front cranium covering portion 22. This edge seal 58 can be seen engaged with the baby's skin on Figure 4. The edge seal 58 is also made from expanded polyethylene foam.

Referring back to Figure 2, the front cranium covering portion 22 also includes a noise absorbing lining 60 of expanded polyethylene foam. The lining 60 is adapted to cover and protect the fontanelles on the baby's cranium from externally generated noise.

The front cranium covering portion 22 also defines a channel 61 which is adapted to receive a ventilator gas tube (not shown).

The operation of the system 10 for protecting a baby's ears and cranium from externally generated sound will now be described with reference to Figures 7 to 12, perspective views of the operation of the system 10.

As shown in Figure 7, the protective covering 16 is in the open configuration and the baby 5 is lowered into position.

Referring to Figure 8, the rear cranium covering portion inflation pad 56 is inflated by pumping a first inflation pump 18a. The inflation pad 56 raises the baby's head 62 and pumping continues until the baby's ears 60 are aligned with each ear protection unit 36.

The front cranium covering portion 22 and the ear covering portions 24,26 are then pivoted with respect to the rear cranium covering portion 20 to the position shown in Figure 9 and each ear covering portion 24,26 is snap-fitted to the front cranium covering portion 22 by fixings 32.

Referring now to Figure 10, the inflation bladders (not shown) in the ear covering portions 24,26 are inflated using a second inflation pump 18b to engage the ear protection units (not shown) with the skin surrounding the baby's ears as described earlier with reference to Figures 5 and 6. As shown in Figure 11, the support pillow 14 is then inflated using a third inflation pump 18c such that the baby is supported in such away that his spine is straight.

Finally in Figure 12, the anti-noise processing unit 62 is then activated to generate anti-noise within the ear covering portions 24,26. Selection of the correct inflation pump 18 is facilitated by the user interface

19. The panel 19 is shown in Figure 13, an enlarged perspective view of the user interface of Figure 1. The panel includes three apertures 70a,70b,70c through which an air hose 74 (of which only one is shown) connecting one of the inflation pumps 18 to one of the ear covering portion inflation bladder 38, the inflation pad 56 or the support pillow 14. The user can quickly and intuitively select the correct pump 18 by referring to the relevant drawing 76a,76b,76c above each aperture 70a,70b,70c.

The pillow 14 is adapted to maintain the baby's head in a desired orientation, either with the baby's face facing upwards (as shown in Figure 1) or facing to one or other side (as shown in Figure 14).

Also visible on Figure 14 are a number of pillow ribs 80. The ribs 80 control the height of the pillow 14 during inflation. The pillow 14 cannot be inflated beyond the height of the ribs 80 and ensure a flat surface to support the protective covering 16. Referring now to Figure 15 there is shown a perspective view of a protective covering 116 according to a second embodiment of the present invention. The protective covering 116 is adapted to cover at least part of the baby's cranium and is in the form of a band 117 extending from the nape of the baby's neck (not visible) around the sides 181 of the baby's head to the baby's forehead 182. The band 117 is in the form of a strip of cotton having a first end 183 and a second end 184 which are releasably attachable to each other on the baby's forehead 182.

The band 117 further defines apertures 184 which are positioned around the baby's ears 160. The band 117 of Figure 15 can be used to support a medical device such as feed tube (not shown) in the desired position. In the embodiment shown in Figure 15, the feed tube would be simply trapped between the protective covering 116 and the baby's forehead 182. In other embodiments a cushioning layer could be provided between the tube and the baby's skin or the tube could pass over the external surface of the protective covering 116, the tube being held in place by, for example, a releasable strap. Figure 16 is a perspective view of a protective covering 216 according to a third embodiment of the present invention. The protective covering 216 is similar to the band 117 of the second embodiment, however, in addition, the protective covering 216 includes first and second ear cover supports 285. Each ear cover support 285 is attached to the edge of an aperture 284 defined by the protective covering 216. As can be seen from Figure 17, a perspective view of the protective covering

216 of Figure 17, ear covering portions 224,226 are attachable by means of a threaded connection 286 (visible on Figure 16). The ear covering portions 224,226 are adapted to provide passive noise reduction. Although not clearly visible for Figure 16, an inner surface of each ear cover support 285 is provided with a foam layer to acoustically seal around the ear 260

Figure 18 is a perspective view of a protective covering 316 in a first configuration according to a fourth embodiment of the present invention. The protective covering 316 is provided with a visor 386 which can be moved from the

first configuration in which the baby's eyes are exposed to a second configuration, shown in Figure 19 in which the baby's eyes are covered.

Figure 20 is a perspective view of a protective covering 416 in a first configuration according to a fourth embodiment of the present invention. The protective covering 416 includes an upper cranium covering portion 487. As with the protective covering 116 of the second embodiment, the protective covering 416 comprises a band 417 which wraps around the baby's head from the nape of the baby's neck to the baby's forehead 482 In Figure 20 the band 417 is shown in the first configuration which is a fold flat configuration. The first and second ends 483,484 are attached by a Velcro fastener (not shown). The upper cranium covering portion 487 is then folded over the crown 488 of the baby's head. The upper cranium covering portion 487 defines two legs 493,494, each leg being provided with a first half of a Velcro fastener 489,490. Each leg 494,494, once folded, engages with a complementary second half 491,492 of a Velcro fastener mounted to the portion of the protective covering 416 which covers the baby's forehead 482, as shown in Figure 21, a perspective view of the protective covering 416 of Figure 20 in a second configuration. As can be seen from Figure 21 the upper cranium covering portion only partially covers the upper cranium (particularly over the fontanelles) leaving other parts uncovered to permit the dissipation of heat. Various modifications may be made to the embodiments of the protective cover described above without departing from the scope of the invention. For example, although the front cranium covering portion is shown pivotally mounted to the rear cranium covering portion, it could be slidably mounted. Additionally, although the anti-noise processing unit 62 is external to the protective covering 16, it could be incorporated within the ear covering portions 24,26. Furthermore, cooling could be provided to the baby's cranium and ears by incorporating a conduit to circulate a chilled fluid. The protective covering described above is suitable for a range of sizes of babies' heads. For sizes of heads outwith the range, a smaller or larger protective covering could be provided. Alternatively, the maximum extension of the ear protection units could be increased to fit all or most sizes of heads. It may also be desirable to provide the facility to be able to extend the acoustic seal 58 and the lining 60 towards the baby's skull. To achieve this a similar inflation system to that used in the ear protection units may be used.