WO2012054963A1

WO2012054963A1 - Head and/or neck support device and method

Info

Publication number: WO2012054963A1
Application number: PCT/AU2011/001354
Authority: WO
Inventors: Darren Stuart Ross; Andrew Paul Seymour
Original assignee: Tri-Cycle Pty Ltd
Priority date: 2010-10-25
Filing date: 2011-10-25
Publication date: 2012-05-03
Also published as: CN103402399A; EP2632298A4; US20130232694A1; EP2632298A1; JP2013541384A; AU2011320010A1

Abstract

The present invention relates to spinal support and a means for support and alignment for the neck in the side, supine or semi prone or prone positions comprising; supporting the user's head and/or neck in a first user position with a first adjustable support means adapted to locate the user's head and/or neck at a first height relative to a supporting surface for the user; supporting the user's head and/or neck in a second user position with a second adjustable support means adapted to locate the user's head and/or neck at a second height relative to a supporting surface for the user; wherein the first and second heights relative to the supporting surface for the user are substantially different such that substantially constant cervical spinal alignment for the user is maintained In both positions.

Description

HEAD AND/OR NECK SUPPORT DEVICE AND METHOD RELATED APPLICATIONS

This application claims priority to Australian Provisional Patent Application No. 2010904735 in the name of Tri-cycle Pty Ltd, which was filed on 25 October 2010, entitled "Method, System and Apparatus for Support" and Australian Provisional Patent Application No. 2011904017 in the name of Tri-cycle Pty Ltd, which was filed on 30 September 2011 and also entitled "Method, System and Apparatus for Support" and the specifications thereof are incorporated herein by reference in their entirety and for all purposes.

FIELD OF INVENTION

The present invention relates to spinal support. In particular, In one form the present invention relates to a method, system and apparatus providing support for the head, neck and/or upper spine in a resting, sleeping or generally horizontal position. In one particular form, the invention relates to a means for providing support and alignment for the neck in the side, supine or semi prone or prone positions. While it will be convenient to hereinafter describe the invention in relation to its use as a structure for providing adjustable support to the neck, it should be appreciated that the present invention is not limited to that use, only. BACKGROUND ART

Throughout this specification the use of the word "inventor" in singular form may be taken as reference to one (singular) inventor or more than one (plural) inventor of the present invention.

It is to be appreciated that any discussion of documents, devices, acts or knowledge in this specification is included to explain the context of the present invention. Further, the discussion throughout this specification comes about due to the realisation of the inventor and/or the identification of certain related art problems by the inventor. Moreover, any discussion of material such as documents, devices, acts or knowledge in this specification is included to explain the context of the invention in terms of the inventor's knowledge and experience and, accordingly, any such discussion should not be taken as an admission that any of the material forms part of the prior art base or the common general knowledge in the relevant art in Australia, or elsewhere, on or before the priority date of the disclosure and claims herein. In practice as a physiotherapist in the field of spinal manipulative physiotherapy, the inventor has recognised that a cause of neck pain may be inappropriate pillows or inadequate support to the upper spine when resting or sleeping. However, it is also important to realise that people with not only painful conditions of the neck but also those with asymptomatic necks may have difficulty in finding a suitable pillow which will provide for support and comfort to the neck and upper spine and which can cater to the natural change in position of a person as they sleep or rest in the horizontal, including particularly the side and supine (on back) positions.

Figure 1 shows a number of positions of the neck and head when a subject is laying down. With reference to figure 1 , figures 1 (a) and 1 (c) In particular show the axis of head and neck rotation indicated by line "A". This axis is considered to intersect the mid point of the apex of the skull and essentially forms a pivot point or axis for the head and neck. An issue arises in that in the supine position, for example, shown in the left hand side image of figure 1 (c) the distance or height, hi , from the resting surface "S" to axis "A" is different to that of the corresponding height, h2, shown in right hand side image of figure 1 (c) for the subject when lying in the side position. There are also several variables to this being head size, shape, shoulder width, curve of the thoracic spine etc. This discrepancy (h2 - hi ) means that a single height, h, cannot accommodate for both of the more common sleeping positions being side lie and supine. It also follows that the height discrepancy noted above is also evident where a person moves from one to another of, or a combination of side, supine, prone or semi-prone positions.

Figure 1a illustrates the height discrepancy between side and supine positions where due to the shape and configuration of the human head requiring support for both head and neck regions, there is a height discrepancy relative to the resting surface S, from side to supine positions for the neck height, Η_ηβ<*, and head or skull height H_SK_UII. respectively.

It is to be noted that height in this context does not specifically relate to a vertical component, only, of separation from the resting surface S but rather the actual distance (or vectorial sum of vertical and horizontal distances) between the head and resting surface S. In other words, whereas the horizontal disposition of the resting surface S in figure 1 is a case in which the height h is one and the same as the vertical component of separation, if the resting surface S is angled to the horizontal then this height h will include both vertical and horizontal components.

Generally, a convex surface of the skull does not rest well on a flat surface and, accordingly, the pivoting point of the head, as described above, means that varying heights may be required for a pillow to make it suitable for supporting the neck and upper spine in varying positions. Conversely, this might not be an issue if the head was round with a central pivot point.

In the past, manufacturers have tried to solve these issues by using contour pillows to assist with support but this does not necessarily solve the problems of having differing support needs in different positions. Contour pillows allow for increased neck support but do not necessarily vary support with a change in height of the subject's head. Pillows of the prior art that are contoured in a particular form or moulded in a certain way often have limited flexibility and do not allow free movement during sleep. They may also limit the positions the user may take during rest and sleep, and this can cause discomfort.

Other solutions have involved the trialling of air and water adjusting devices to assist with head position but this does not solve the problem outlined above. The advent of memory foam has assisted but not solved the entire issue noted above. For example, the use of different materials has addressed the ability for a pillow to conform to a single sleeping position but does not accommodate more than one sleep or rest position as the properties of memory foam or other such materials do not adequately address the height differential issue noted above with respect to multiple positions. Further, the use of memory foam does not allow for enough height reduction or gain due to the behaviour- or capacity of the material itself. Also, memory foam does not necessarily deform to a fixed position. Generally, memory foam only responds to weight pressure not the position of the resting subject and its properties may change depending on temperature. Memory foam allows for the height of a pillow or cushion from such material to adjust to pressure. The height issue is still not solved in both supine and sidelye or prone and semi-prone positions.

Furthermore, there are a number of specific devices and measures that are used in healthcare and/or for well being that have not necessarily been successfully integrated with the use of cushions or pillows in supporting the head, neck and upper spine. For example, sleep apnea (CPAP) masks, as would be recognised by the person skilled in the art, are designed for their own specific purpose and whilst they are also designed for use during sleep, they may be uncomfortable. As another example, there is also a need to cater for those who require immobilization for neck fractures, neck surgery, chronic pain or upper thoracic injuries. In this instance there are immobilisation devices such as, for example, a halo thoracic immobilization device as would be recogninsed by the person skilled in the art, which are cumbersome for the patient that wants to rest or sleep.

Apart from therapeutic devices as noted above, there may be other devices and consumer products that users may wish to have incorporated into a device for providing support whilst resting or sleeping, such as for example, devices for listening to music and or radio. Ordinarily these devices, if they can be warn by a user or located close to the person's ears, for example, then they only tend to be a hindrance to the comfort of the person when seeking a cushioned support for their head, neck, shoulders and upper spine.

SUMMARY OF INVENTION

An object of embodiments of the present invention is to provide for adjustable support for the head, neck, or upper spine in the side, supine, prone and semi-prone positions.

It is also an object of the embodiments described herein to overcome or alleviate at least one of the above noted drawbacks of related art systems or to at least provide a useful alternative to related art systems.

In a first aspect of embodiments described herein there is provided a head and/or neck support device comprising:

a frame member for supporting the head and/or upper neck of a user, the frame member adapted to be operatively associated with first and second adjustable support means;

wherein the first adjustable support means is adapted to provide support for the user's head and/or neck in the supine or prone position and the second adjustable support means is adapted to provide support for the user's head . and/or neck in the side lying or semi-prone position such that cervical spinal alignment is substantially constant in both supine and side lying positions.

The first and second adjustable support means, in combination, are preferably adapted to provide first and second heights, respectively, for the user's head and/or neck with respect to a supporting surface for the support device in both the supine and side lying positions, for example, where said first and second heights are different in order to maintain a substantially constant cervical spinal alignment for the user.

The first and second adjustable support means may be biased to provide self adjustment under load of the weight of the user's head and/or neck. In other words, the first and second adjustable support means are biased to provide height adjustment under load of the weight of the user's head and/or neck so as to maintain a substantially constant cervical spinal alignment for the user moving from one to another of a combination of side, supine, semi prone or prone positions

Furthermore in a preferred embodiment, the first and second adjustable support means, in combination, are operatively associated to maintain substantially constant cervical spinal alignment during movement of the user from one position to another position.

Preferably, the first adjustable support means comprises a single mechanism located within a base of the frame member.

Furthermore, the second adjustable support means may comprise at least one other and preferably two mechanisms each located within respective side walls or lateral wings of the frame member.

Preferably, the frame member is further adapted to house cushioning means for supporting contact with the user's head and/or neck. In preferred embodiments the cushioning means comprises foam or memory foam or like material.

. The frame member may be further adapted for attachment of at least one therapeutic device. The at least one therapeutic device may comprise a CPAP device.

The frame member may be embodied in a number of forms including but not limited to the form of a flat plate or in a preferred embodiment as a shell that may be deformed by integral or attachable adjustable means. The frame member may also be embodied as an orthotic. In the context of the present description an orthotic may be taken as an appliance designed to straighten or support a body part or a device or brace to control, correct, or compensate for an anatomical deformity, as would be recogninsed by the person skilled in the art.

In another aspect of embodiments described herein there is provided a method of supporting the head and/or neck of a user comprising the steps of: supporting the user's head and/or neck in a first user position with a first adjustable support means adapted to locate the user's head and/or neck at a first height relative to a supporting surface for the user;

supporting the user's head and/or neck in a second user position with a second adjustable support means adapted to locate the user's head and/or neck at a second height relative to a supporting surface for the user;

wherein the first and second heights relative to the supporting surface for the user differ to the extent that substantially constant cervical spinal alignment for the user is maintained in both user positions. Reference to both user positions may comprise a supine or side lying position for the first and second user positions, respectively. Alternatively, reference to both user positions may comprise a prone or semi-prone position for the first and second user positions, respectively.

The first and second adjustable support means may be biased to provide a self adjustment of height under load of the weight of the user's head and/or neck.

In a preferred embodiment, as noted above, the first user position is the supine position and the second user position is a side lying position. Alternatively, in another embodiment, the first user position is the prone position and the second position may also allow for a semi prone sleeping position.

Furthermore in preferred embodiments, the first and second adjustable support means, in combination, are operatively associated to maintain substantially constant cervical spinal alignment during movement of the user from one position, ie supine or side lying, to the to the other position, ie side lying or supine, respectively.

In another aspect of the embodiments described herein there is provided a support device wherein the frame comprises a deformable shell. In this preferred embodiment, the first and second adjustable support means may be integral to the shell. The support device, in this aspect of embodiments may further comprise strap means extending between the sides of the shell, the strap means being of adjustable length wherein, the arrangement being such that tension applied to the strap means causes the shell to deform to define a height of the support surface. The unit may have one or more areas of height adjustment. The strap means may comprise a plurality of straps spaced between the edges of the shell each strap being independently adjustable in length. Further, the strap means may comprise a plurality of straps spaced between the edges of the shell where the length of the straps are adjustable in groups. Furthermore, the strap means may be rigid, semi rigid and/or elastic.

In this aspect of embodiments, apertures may be provided in the sides of the shell for receiving the strap means. The rear of the shell may comprise at least one transversely extending slot therethrough. The at least one transverse slot may be configured to define at least one transverse land, wherein the at least one transverse land may be adapted to be grasped to assist in adjusting the strap means. The at least one transverse land preferably supports means thereon for adjustability securing a free end portion of the strap means.

The support may further comprise at least one stabilising bar formed from an integral portion of the shell and this may be adapted to remain in line with a supporting surface when the shell is deformed. Preferably, the support is in the form of an outer removable support cushion adapted for placement against a resting surface or device.

Other aspects and preferred forms are disclosed in the specification and/or defined in the appended claims, forming a part of the description of the invention.

In essence, embodiments of the present invention stem from the realization that the height required for various positions when resting or sleeping such as, for example, supine (back sleeping) and side sleeping is different as a consequence of several anatomical variables including head size, shape, shoulder width, curve of the thoracic spine and, as such the use of a device which acts as a medium between the convex skull or neck and the flat resting surface should gradually accommodate distance from resting surface to point of axis along with a self levelling height adjusting device. In preferred embodiments the present invention combines the use of positioning/levelling devices along with a solid device to accommodate to the change in positions along with the comfort factor of memory foam to ensure final comfort and slight accommodation.

Advantages provided by embodiments of the present invention comprise the following:

• Correct positioning device ensures spinal alignment in side lying and supine (on back) this allows the muscles to relax and allows any irritated, degenerative and arthritic joints the ability to avoid aggravation;

• Ability to partially immobilize neck or head movements;

• Ability to provide attachment points for auxiliary devices including consumer products or therapeutic medical devices such as CPAP masks/tubes/sleep apnea devices;

• A cut out on an orthotic embodiment between the neck and the shoulder assists in correct positioning of the neck by ensuring maximum support of the neck and maintaining a neutral supported spine.

• The use of self adjusting stabilising bars allow for an inner frame/shell and supporting straps to remain horizontal to the support surface.

Further scope of applicability of embodiments of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the disclosure herein will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Further disclosure, objects, advantages and aspects of preferred and other embodiments of the present invention may be better understood by those skilled in the relevant art by reference to the following description of embodiments taken in conjunction with the accompanying drawings, which are given by way of illustration only, and thus are not limitative of the disclosure herein, and in which:

Figure 1 and 1A illustrates a number of positions of the neck and head when a subject is laying down;

Figure 2 is a side view of an adjustable support means suitable for use with a preferred embodiment of the support device showing the adjustable support means under load in (a) and in an unloaded position (b);

Figure 3 is a graphical representation of the anatomical positions of a user in supine and side lie positions illustrating the arc of head radius from axis to side lying and supine position, respectively;

Figure 4 is a perspective view showing a head and/or neck support device in accordance with one embodiment of the present invention illustrating an orthotic form;

Figure 4a shows perspective side views of an alternate arrangement of the device of figure 4;

Figure 4b shows plan views of the device of figure 4a;

Figure 5 is a side view showing the head and/or neck support device of Figure 4 in use by a user in the side lying position;

Figure 6 is an axial end on view showing the head and/or neck support device of Figue 4 in use by a user in the supine position;

Figure 7 is a top perspective view of a head and/or neck support device in accordance with another preferred embodiment of the present invention in the form of a shell with integral adjustable support means;

Figure 8 is a bottom perspective view of the embodiment of Figure 7;

Figure 9 is a side view of the device of figure 7 in an undeformed state with outer foam Indicated;

Figure 10 is a side view of the support device of figure 7 showing the disposition of the integral adjustable support means in an unloaded position (a) and under load from tensioning means in (b);

Figure 11 shows an end on rear elevation view of the support device of figure 7 Indicating angular adjustment in a transverse direction;

Figure 12 is a top perspective view of the shell device of figure 7 without adjustment straps; Figure 13 is a bottom perspective view of the shell device shown in figure

12;

Figure 14 is an end on perspective view of the shell device shown in figure

12.

DETAILED DESCRIPTION

In one preferred embodiment of the present invention there is provided an orthotic pillow device 100, the internal structure of which is shown in figure 4 for example, which is designed to allow for a smooth transition between side and supine postures of a user where the user's head is depicted by 600 in figures 1 , 5 and 6. The arch of the orthotic matches anthropometric analysis to ensure an anatomically positioned spine is maintained during this transition. Exemplary anthropometric measurements are included in the annexed appendix to this description.

Inbuilt adjusting meohanisms then ensure correct resting position when the side, supine position or other position(s) is matched. Advantageously, adjustments are provided to ensure optimum neck support for back and side sleepers. The unique shape, inbuilt mechanism and contour of the orthotic device provides an optimal solution for people with sleep difficulties as well as being a single solution for all necks of all ages.

With reference to figures 2 to 6 of the accompanying drawings, an exemplary device in accordance with an orthotic variation of the present invention uses three solutions to solve the position issue for people who change postures during sleep and who will have a significant distance variation between supine thoracic contact pressure and neutral cervical spine position and that of side lie body contact pressure to neutral spine position.

Firstly the use of an orthotic like structure 100 enables the accommodation of the different arcs of rotation about the central access of rotation. "A", to maintain a neutral spine position allowing for shoulder or back position. T is device enables the smooth transition from supine to side, for example. Generally, the orthotic structure 100 comprises a base B and at least two side walls, SW, best shown in figures 4, a, 4b, 5 and 6.

Secondly manual or automated (for example biased) adjusting devices 200. as shown in figure 2, incorporated into the orthotic enables a rise and fall of the support so as to act as self levelling device to maintain a maximum and minimum range to allow for variables such as surface sag at contact points between the user's head and/or neck and any outer cushioning for pillow support. As shown schematically in figure 2, the adjusting devices comprise a flat plate 202, a maneuverable means 203 for varying the height of a solid base 204 for attachment of foam cover 300 to support the user's head and/or neck. Alternatives for components of the adjusting devices would be understood by the person skilled in the art yet remain within the scope of embodiments of the present invention. For example, the maneuverable means 203 may comprise wind out adjustable means or alternatively a sliding element. Preferably, there will be a minimum of 3 separate of these devices (comprising, respectively, one first 200a and two second 200b adjustable support means) to allow for one on the surface which comes in contact in supine position as well as two side supports to be set and levelled. Figure 6 illustrates these best.

Thirdly the use of memory foam 300 allows for contact comfort of the head to the solid adjustable devices 200. By way of example, figure 11 has an indication of the thickness 301 of memory loam within a covering of a frame member of an embodiment of the support device described herein

It is noted that when the person is weight bearing with the head on a surface the adjusting device 200 takes 100% of the pressure and the orthotic structure 100 moves relative to the device. This enables the accurate position to be attained whilst ensuring that the head is not too encapsulated within the orthotic 100.

Figure 3 illustrates the anatomical position of a user. In particular, a longitudinally cross section view showing:

• Arc1 - the arc of head radius from axis to side position due to wider shoulder than trunk width;

• Arc2 - the arc of head radius to supine position and;

• HS - cross sectional head shape.

Also in figure 3, there is shown the supine and side (or side lye) positions schematically illustrating the difference in height requirements from side to supine for head position. The solid orthotic structure 100 enables attachment of CPAP masks, sleep apnea devices and the insertion of speakers is also envisaged. This will be attached by a standard fixation method to enable universal application. Figure 4b shows side apertures 201 for fitment of adjustable devices 200, for example, and may also accommodate fitment of other accessories mentioned below.

Details of suggested adjusting device 200:- This will be built into the orthotic and mounted on side apertures 201 for instance and form an enclosed contact area. A minimum of three adjustable support devices 200 are included, namely one base device 200a and two side devices 200b. The orthotic 100 will move relative to the central or base adjusting device 200a and it will return to an "open" position when the surface of the orthotic is unloaded, Figure 2 shows an example of an adjustable support device 200 in the loaded and unloaded positions designated as figure 2(a) and figure 2(b). In an unloaded position it will return to an open position to ensure that the head is not restricted from unsupported sides. However in the case of the requirement for complete immobilisation (such as spinal fracture) these will be able to be locked into full head contact to enable maximum support. This is so that when a thoracic harness is added the trunk and head can be held as a single unit. Thus enabling comfort for sleeping whilst providing maximal support.

The pillow orthotic of the preferred embodiment is a 3 dimensional device providing for 2 degrees of freedom or adjustment namely an adjustable height support pillow for side and back sleepers to achieve correct biomechanical support. It may comprise the following features and/or advantages:

Correct spinal alignment;

Maintenance alignment all night;

Add on functionality;

Sleep apnea splint attachment;

Orthotic Audio speakers;

Thoracic section to immobilize for cervical fractures/unstable cervical spines;

Self adjusting height mechanism;

Orthotic like structure;

Attachment for CPAP, oral sleep apnea devices; Attachment for thoracic braces;

Ability to be self adjusting or fully immobilize the cervical spine (such as when required for fractures or post surgery); and

In built speakers.

The pillow orthotic is an answer to not only prescribing a desirable multi- positional pillow but will also assist with pain control and relief.

it is considered that a 3D and or multi axis device and a match of an oval head with a flat bed surface can address the above noted related art problems. The pillow orthotic of preferred embodiments does just this. It is an adjustable support device that may also allow for attachment of thoracic and facial devices such as CPAP, sleep apnea devices and thoracic immobilization braces.

Embodiments will use a small layer of memory foam 300 and a manual adjustment device 200.

It solves the issue of two planes by adjusting against a more rigid surface. Due to the design of this product it also gives the option for some other additions which are unique. These being the ability to add on an attachment for complete immobilization, to allow for a pillow for those with neck fractures or post surgery for the neck; or for those using oral sleep apnea devices and CPAP machines.

The concept of a preferred embodiment is a pillow in the form of a orthotic like structure as described above which is a combination of solid and deformable products with a self adjusting height altering device. It is also innovative in its ability to have attachments to allow solutions to medical conditions and will also have entertainment features with the option for inbuilt speakers for auxiliary jack devices.

A person lies in the orthotic like device. The self adjusting heights will work with the head weight to self adjust to the persons required height in both the side and back sleeping position. When a person rolls and changes their position, the orthotic will roll with the person. The shoulder side of the pillow is cut out, as shown at 400 in figure 4, to allow for the pillow to be closely situated to the neck in use which provides increased neck support. When required the adjustable sides can be locked in place to provide "complete" immobilization. The firm surface has screw in regions, shown clearly at 201 in figure 4, 4a and 4b , which allow for attachment of support devices 200, or more specifically 200b, as shown and other devices. Accordingly, the orthotic pillow can also accommodate a module(s) for speakers. The adjustable surface supports a small profile contour insert. The adjustable sections will allow for replacement as well as the provision of customized linen to ensure hygiene. The positioning and form of any fixation attachments for the CPAP, and medical devices would be recognised by the person skilled in the art and are not shown in the accompanying drawings.

In another preferred embodiment, the present invention takes the form of a head and/or neck support comprising a shell that may be deformed by integral adjustable support means. The support in its most preferred form may be inserted into a pillow or cushion.

Referring to Figures 7 to 14, the head and neck support, generally indicated by the numeral 100, comprises a semi rigid shell 200 which may be formed of a plastics material, for example high density polypropylene, ABS (acrylonitrile butadiene styrene) or the like, which in turn may be formed by injection moulding or other forming methods that would be understood and recognised by the person skilled in the art. The central portion 800 of the shell 200 may form an angle with the side portions 900 that is generally an obtuse angle, ie between 90° and 180° and may also include a straight angle of 180° and also a right angle of 90° per se to side portions 900, as shown in the cross sectional transverse view of Figure 1 1 and the end perspective view of Figure 14, for example. This angle subtended by the central portion of the shell may be more clearly seen as the angle subtended by the central portion and the side portions, which is denoted by arrow Q in figures 7 and 14 but best shown in side view by figure 11.

Firstly the use of a frame comprising a shell like structure 100 set at an angle of 90° or greater than 90" and up to 180" between the middle portion 800 and the two outer wings 900 enables the accommodation of the different arcs of rotation about the central access to maintain a neutral spine position allowing for shoulder or back position. This device enables the smooth transition from supine to side.

Secondly manual prescription based adjusting straps 700 for adjustable support devices 200 enables the exact heights required for a sleep position to be set and calibrated to the user. There will be a minimum of 3 separate straps 700 (preferably comprising one first adjustable strap 700a located for the central portion 800 and two second 700b adjustable straps located at the wing portions 900 for deforming the adjustable integral support means 200. In this way, the unit has one or more areas or regions of height adjustment along the shell.

The sides/edges 500 (shown in Figure 8) are joinecT at opposed outer peripheral edge portions by transverse support straps 700b which are length adjustable such that when the support straps 700 are in their fully slackened condition, the inner shell will be near flat as shown in Figure 9 and Figure 10(a). Figure 10 (a) shows the support with untensioned straps, and figure 10 (b) shows the support with tensioned straps. However, when the support straps 700 are shortened or under tension, the support straps 700 each provide a respective increase in support surface height hi and h2 (figure 1). Thus, by selectively adjusting the length of each of the individual support straps 700, the desired amount of height support can be. achieved by an increased or decreased support surface 750 to allow for the differing heights required for side, back sleeping. The support straps 700 may be formed of nylon webbing, silk ribbon, hook and loop material ie Velcro™, leather or a like material. It is preferred but not essential that the material of the straps 700 does not yield. Any yielding of the straps 700 would see alteration in the shelf height and would make customisation and prescription difficult and inaccurate.

In the preferred embodiment each support strap 700 extends through respective opposed apertures or slots 850 which are formed in the outer peripheral edge portions of the sides 500. Figures 12 and 13 show the apertures 850.

With reference to Figure 10(b) in particular, one end 720 of a support strap 700 is fixed to the rear surface 250 of the shell 200 and a free end portion 710 of the support strap 700 is adjustably secured relative to the rear surface of the shell 200. The free end portion 710 may be adjustably secured, for example, by a two part fastening comprising a multiplicity of loops engageable with a multiplicity of hooks such as is sold under the registered trade mark "Velcro™" noted above. In this example, a strip of one part of the fastening is fixed to the rear surface 250 of the shell 200 and a cooperating strip of material is attached to the free end portion 710 of the support strap whereby the free end portion 710 may be selectively positioned following adjustment of the length of the support strap 700. Rather than using Velcro™, as previously described, the free ends 710 of each support strap 700 may be adjusted for length and then joined by way of a conventional buckle arrangement, D-rings or clamps (not shown). Alternatively, other means of securing the free end portion 700 of the support strap to the rear surface 250 of the shell 200 may be employed, for example the free end portion 710 may have a number of holes along its length and a post or prong may be mounted on the rear surface 250 of the shell 200 for receiving and securing the free end portion 710 of the support strap 700. It is envisaged that calibration marks may be Included on the rear surface 250 of the shell and/or on the free end portion 710 of the support strap whereby the length of the support strap 700 may be adjusted by predetermined discrete amounts.

The opening provided by the volume defined by the shell 200 is covered with any sheet of foam, preferably memory foam with a contour to allow for comfort and support of all resting surfaces, to provide a layer 300 which is attached to itself on the rear surface 250. A cover 320, indicated in figure 9 may encompass the layer 300. This cover 320 will also allow for the insertion of a conventional pillow so that the inner shell can be used independently with other pillows such as when travelling or when situations limit the transport of the entire device. The outer foam 300 provides a smooth, continuous support surface for the neck and head of the person to be supported.

The layer 300 also acts as a cushion between the person's neck and the support straps 700 thereby increasing the person's level of comfort. The layer 300 may be formed of suitable cushioning material. A protective cover 320 may also be provided for fitting over the shell to attach the outer foam layer and or other pillows to completely cover it. A conventional pillow cover can also be used over the top of the units cover. This cover may be resealed in any known manner, for example by way of Velcro™ or a zipper such that if another person wishes to use the head and neck support 100, it is a simple matter of opening the protective cover 320 to adjust the length of the support straps 700 to suit the new user and then reseal the protective cover 320. It is also envisaged that the layer 300 may be part of the protective cover 320 and may be removable with the protective cover 320 for cleaning. The rear surface 250 of the shell 200 may have a number of cut-out openings 240 (shown in Figure 8) therein, for example holes or transverse slots, to facilitate ventilation and to provide additional flexure of the semi-rigid shell 200, if required. The openings 240 are preferably in the form of transverse slots whereby transverse lands 260 (shown in Figure 13) are provided between spaced openings 240, the lands 260 providing a surface; on which the means of securing the other end 700 to the rear surface 250 may be situated, for example in the preferred embodiment each land 260 has one part of a strip of Velcro™, as previously described, mounted thereon which cooperates with a second strip of Velcro™ which is attached to the free end portion 710 of the support strap 700 whereby, following selective adjustment of the length of each of the individual support straps to provide the desired amount of lateral and back support, the free end portion 710 of the support strap may be secured relative to the land 260.

The lands 260 also provide a convenient means by which the shell 200 may be grasped, thereby providing a point of purchase which is of assistance when one is required to pull on a support strap 700 to shorten its length.

The land formed by a partial cut in the rear surface 250 creates a stabilising device 270. This device 270 ensures that despite the convexity of the rear surface 250 as shown in figure 11 , for example, creates a support to prevent rotation of the convex rear surface 250 when the straps 700 are tensioned against the supporting resting surface. These support bars 270 will be reinforced to ensure that the bars do not flex as the straps 700 are tensioned against the shell 200.

The use of self adjusting stabilising bars allow for an inner frame/shell and supporting straps to remain horizontal to the support surface. These reinforced members work by remaining rigid whilst the frame/shell is tensioned. This creates an supporting wing. The stabilisation of this could also be achieved by a wedge unit which was trialled or a cut out depression on the outer foam to support or support from the foam itself.

The head and neck support 200 may be used as a removable support cushion to be placed against the flat surface of a resting device to provide better, or more appropriate, neck support in all planes. While this invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification(s). This application is intended to cover any variations uses or adaptations of the invention following in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth.

As the present invention may be embodied in several forms without departing from the spirit of the essential characteristics of the invention, it should be understood that the above described embodiments are not to limit the present invention unless otherwise specified, but rather should be construed broadly within the spirit and scope of the invention as defined in the appended claims. The described embodiments are to be considered in all respects as illustrative only and not restrictive.

Various modifications and equivalent arrangements are intended to be included within the spirit and scope of the invention and appended claims. Therefore, the specific embodiments are to be understood to be illustrative of the many ways in which the principles of the present invention may be practiced. In the following claims, means-plus-function clauses are intended to cover structures as performing the defined function and not only structural equivalents, but also equivalent structures. For example, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface to secure wooden parts together, in the environment of fastening wooden parts, a nail and a screw are equivalent structures.

"Comprises/comprising" and "includes/including" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. Thus, unless the context clearly requires otherwise, throughout the description and the claims, the words 'comprise', 'comprising', 'includes', 'including' and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to". Appendix

Anthropometric data - being a summary of the well documented ANSUR measurements ***ref1988 U.S. Army Anthropometry Survey (ANSUR) Head Sizing:

Definitions

103 - Biacromial Breadth - The distance between the right and left acromion landmarks at the tips of the shoulders is measured with a beam caliper. The subject sits erect. The shoulders and upper arms are relaxed and the forearms and hands are extended forward horizontally with the palms facing each other. 122 - Bideltoid Breadth - The maximum horizontal distance between the lateral margins of the upper arms on the deltoid muscles is measured with a beam caliper. The subject sits erect looking straight ahead. The shoulders and upper arms are relaxed and the forearms and hands are extended forward horizontally with the palms facing each other.

144 - Bitragion - Coronal Arc - The surface distance between the right and left tragion landmarks across the top of the head is measured with a tape. The head is in the Frankfort plane.

146 - Bitragion - Crinion Arc - The surface distance between the right and left tragion landmarks across the top of the forehead at the lowest point of the hairline (crinion). Measured with a tape.

150 - Bitragion - Menton (chin) Arc - The surface distance between the right and left tragion landmarks across the chin landmark at the tip of the chin is measured with a tape. The teeth are lightly occluded.

152 - Bitragion - Minimum Frontal Arc - The surface distance between the right and left tragion landmarks across the forehead just above the ridges of the eyebrow is measured with a tape.

156 - Bitragion Submandibular Arc - The surface distance between the right and left tragion landmarks across the submandibular landmark at the juncture of the jaw and the neck is measured with a tape. The head is in the Frankfort plane and the teeth are lightly occluded.

158 - Bitragion-Subnasale Arc - The surface distance between the right and left tragion landmarks across the subnasale landmark just under the nose is measured with a tape.

165 - Bizygomatic Breadth - The maximum horizontal breadth of the face (between the zygomatic arches) is measured with a spreading caliper

219 - Cervicale Height - The vertical distance between a standing surface and the cervicale landmark on the spine at the base of the neck is measured with an anthropometer. The subject stands erect with the head in the Frankfort plane.

220 - Cervicale Height (Sitting) -The vertical distance between a sitting surface and the cervicale landmark on the spine at the base off the neck is measured with an anthropometer. The subject sits erect looking straight ahead. The shoulders and upper arms are relaxed and the forearms and hands are extended forward horizontally with the palms facing each other. The thighs are parallel and the knees are flexed 90°. 427 - Head Breadth - The maximum horizontal breadth of the head above the attachment of the ears is measured with a spreading caliper.

430 - Head Circumference - The maximum circumference of the head above the attachment of the ears is measured with a tape passing just above the ridges of the eyebrows and around the back of the head.

441 - Head Length - The distance from the glabella landmark between the browridges to the posterior point on the back of the head. Measured with a spreading caliper.

586 - Menton-Nasal Root Depression (Sellion) - The distance between the . menton landmark at the bottom of the chin and the sellion landmark at the deepest point of the nasal root depression. Measured with a sliding caliper. The teeth are lightly occluded.

636 - Neck Circumference (Base) - The circumference of the base of the neck is measured by a tape passing over the drawn lateral and anterior neck landmarks. The subject stands erect with the head in the Frankfort plane. Shoulders and upper extremities are relaxed.

637 - Neck Circumference (Below Larynx) - The maximum circumference of the neck at a point just below the bulge of the thyroid cartilage (Adam's apple). Measured with a tape.

639 - Neck Circumference (Over Larynx) - The circumference of the neck at the level of the infrathyroid landmark (Adam's apple). Measured with a tape.

641 - Neck Height (Lateral) - The vertical distance between a standing surface and the trapezius landmark on the right side of the neck. Measured with an anthropometer. Subject stands erect with the head in the Frankfort plane. Shoulders and u per extremities are relaxed.

647 - Neck Length (Posterior - Nuchale) - The surface distance from the nuchale (the lowest palpable point of the surface distance along the spine from cervicale to the occiput) to the cervicale.

648 - Neck - Bustpoint (Thelion) Length - The distance between the trapezius landmark at the right side of the neck and the right bustpoint landmark on women or the right nipple (thelion) on men. Measured with a tape. Subject stands erect looking straight ahead. Shoulders and upper extremities are relaxed.

Reference for data ANSUR- 1988 U.S. Army Anthropometry survey

Claims

CLAIMS:

1. A head and/or neck support device comprising:

wherein the first adjustable support means is adapted to provide support for the user's head and/or neck in the supine or prone position and the second adjustable support means is adapted to provide support for the user's head and/or neck in the side lying or semi-prone position such that cervical spinal alignment is substantially maintained in both supine and side lying positions.

2. A support device as claimed in claim 1 wherein first and second adjustable support means, in combination, are adapted to provide first and second heights, respectively, for the user's head and/or neck with respect to a supporting surface for the support device in the supine/prone and semi-prone/side lying positions, where said first and second heights are different in order to maintain a substantially constant cervical spinal alignment for the user. 3. A support device as claimed in claim 1 or 2 wherein the first and second adjustable support means are biased to provide height adjustment under load of the weight of the user's head and/or neck so as to maintain a substantially constant cervical spinal alignment for the user moving from one to another of a combination of side, supine, semi prone or prone positions.

4. A support device as claimed in claim 1 , 2 or 3 wherein the first and second adjustable support means, in combination, are operatively associated to maintain substantially constant cervical spinal alignment during movement of the user between supine/prone and semi-prone/side lying positions.

5. A support device as claimed in any one of the previous claims wherein the first adjustable support means comprises one of:

a single mechanism located within a base of the frame member; multiple mechanisms located within a base of the frame member;

at least one strap.

6. A support device as claimed in any one of the previous claims wherein the second adjustable support means comprises at least two mechanisms each located within respective side wings of the frame member.

7. A support device as claimed in any one of the previous claims wherein the frame member is further adapted to accommodate cushioning means for supporting contact with the user's head and/or neck.

8. A support device as claimed in claim 7 wherein the cushioning means comprises one or a combination of foam, down, polyester, or memory foam. 9. A support device as claimed in any one of the previous claims wherein the frame member is further adapted for attachment of at least one therapeutic device.

10. A support device as claimed in claim 9 wherein the at least one therapeutic device comprises a CPAP or steep apnea device.

1 . A method of supporting the head and/or neck of a user comprising the steps of:

supporting the user's head and/or neck in a first user position with a first adjustable support means adapted to locate the user's head and/or neck at a first height relative to a supporting surface for the user;

wherein the first and second heights relative to the supporting surface for the user are substantially different such that substantially constant cervical spinal alignment for the user is maintained in both positions.

12. A method as claimed in claim 11 wherein the first and second adjustable support means are biased to provide a self adjustment of height under load of the weight of the user's head and/or neck. 13. A method as claimed in claim 11 or 12 wherein the first user position is one of the supine or prone positions and the second user position is one of a side lying or semi-prone position.

14. A support device as claimed in claim 1 wherein the frame comprises a deformable shell. 5. A support device as claimed in claim 1 or 14 wherein the first and second adjustable support means are integral to the shell. 16. A support device as claimed in any one of claims 14 or 15 further comprising strap means extending between the sides of the shell, the strap means being of adjustable length wherein, the arrangement being such that tension applied to the strap means causes the shell to deform to define a height of the support surface.

17. A support device as claimed in claim 16 wherein the strap means comprises a plurality of straps spaced between the edges of the shell each strap being independently adjustable in length. 18. A support device as claimed in claim 16 wherein the strap means comprises a plurality of straps spaced between the edges of the shell where the length of the straps are adjustable in groups.

18. A support device as claimed in claim 17 or 18 wherein the straps are individually adjustable to provide one or more regions of the shell that may vary in height.

19. A support device as claimed in any one of claims 16 to 18 wherein the strap means is rigid, semi rigid and/or elastic.

20. A support device as claimed in any one of claims 14 to 19 wherein apertures are provided in the sides of the shell for receiving the strap means.

21. A support device as claimed in claim 20 wherein the rear of the shell comprises at least one transversely extending slot therethrough. 22. A support device as claimed in claim 21 wherein the at least one transverse slot is configured to define at least one transverse land.

23, A support device as claimed in claim 22 wherein the at least one transverse land is adapted to be grasped to assist in adjusting the strap means.

24. A support device as claimed in claim 21 or 22 wherein the at least one transverse land supports means thereon for adjustably securing a free end portion of the strap means. 25. A support device as claimed in any one of claims 14 to 24 further comprising at least one stabilising bar formed from an integral portion of the shell and adapted to remain in line with a supporting surface when the shell is deformed. 26. A support device as claimed in any one of claims 1 to 10 or 14 to 25 wherein the support is in the form of an outer removable support cushion adapted for placement against a resting surface or device.

27. A method or protocol as herein disclosed.

28. A device, apparatus or system as herein disclosed.