WO2008020209A2

WO2008020209A2 - Body part immobilisers

Info

Publication number: WO2008020209A2
Application number: PCT/GB2007/003117
Authority: WO
Inventors: Vincent Peter Lyles; Glen Thomas Gears
Original assignee: Lysgear Limited
Priority date: 2006-08-15
Filing date: 2007-08-15
Publication date: 2008-02-21
Also published as: WO2008020209A3

Abstract

A body part immobiliser comprises a flexible envelope (1) which contours to the body part. The envelope (1) includes at least one vent (9) to outside the envelope (1). Means (5) provide a curable foam to the inside of the envelope (1). Means such as bladders (2) are connected to the or each vent (9) for collecting excess foam.

Description

BODY PART IMMOBILISERS

The present invention relates to body part immobilisers, such as splints, braces, radiotherapy cushions, and the like, and also to other cushioning devices such as those for use in packaging.

When ambulance crews attend emergencies they are often confronted by people with suspected fractures and/or dislocations. In road traffic accidents, for example, neck injuries are common and such injuries require immobilisation in a neutral position. Once at hospital, it is usual for the immobilising device to be removed for examination of the patient but often it may remain in place for a long time so the comfort of the device becomes paramount.

Current devices for immobilisation of body parts include hard neck braces, such as described, for example in WO 96/09802, US 5,788,658, and US Re. 36,745, and rigid splinting such as described in US 2004167450,

US 4383526 and WO 03/082161 , for injured limbs. Because of the rigidity of such devices, it is often painful applying them to the injured body part and application can further aggravate an injury. Moreover, such devices either come as "one size fits all", or in many different sizes, which then need to be carried within the ambulance and this reduces the effective space in the ambulance. The "one size fits all" devices are often a compromise which require much careful adjustment to fit. The many adjustments are time consuming and can further distress the injured person. In many instances, these devices contain metal portions which are radio opaque and may subsequently hinder the taking of informative x-ray images. Moreover, current immobilisation devices for use at accidents are relatively expensive as single-use items. Thus there exists a need for an inexpensive, single use immobilisation device which is easy to use effectively on a large range of body sizes and which stows compactly before use. Moreover, as a single- use item, it would be advantageous for the device to have minimal environmental impact upon disposal. In the hospital setting, there are several ways of immobilising body parts but they do not lend themselves to use in an emergency situation. For example, Scotchcast™, manufactured by 3M, is a bandage impregnated with a water-activated polyurethane resin, which is wrapped around the body part and then allowed to cure. Often the resulting cast is able to weight bear within 20 minutes and these types of casting materials have achieved wide success. However, such a long curing time would be unacceptable at the scene of an accident and the amount of handling of the limb to apply the bandage would likewise be unacceptable and even contra-indicated. US 6695801 describes a form-in-place orthopaedic splint system which uses a bag containing a liquid polyol and an inner envelope containing an isocyanate. The unit is sealed to contain both liquids. When the inner envelope is broken the two components are mixed to form a polyurethane foam, which sticks to the bag and is then moulded to the contours of the body part. It is suggested that about 2 minutes is used to knead the ingredients together and that the curing time should be between 8 to 12 minutes. These suggested timings are far too long for emergency use. Moreover, the description of "kneading" ingredients and then moulding the foam is suggestive of a fine bubble/cream consistency foam. It should also be noted that US 6695801 teaches the production of a foam in a bag, which foam is encouraged to adhere to the inner wall of the bag in a manner which lends itself to moulding to a body form. This would be cumbersome in an emergency environment. Moreover, it would appear that the splint would be even more cumbersome as the patent fails to describe what happens to the substantial volumes of gas which are typically generated when making polyurethane foams and other thermoset foams.

In CT and MRI scanners there is a need to keep the head and neck still. Currently sand bags are used, which are ineffective because the sand flows away from the patient, or blocks of foam are strapped to the patient and the stretcher, which have a poor fit and are uncomfortable.

Bionix and Medtec both provide equipment to make custom foam cushions for immobilising patients for radiotherapy. They both provide open- necked bags and separate containers for the two precursors of the foam resin. The precursors have to be carefully measured out and poured into the open neck bag, some sort of seal effected, and the bag is then placed around the patient. Both companies acknowledge the large problem of resin contamination of patient or staff. Moreover they describe foams which take 8-10 minutes to set.

Creating rigid foam in a bag is not a new technology; it has been used in packaging for many years. WO 98/46498 is an example of foam-in-bag packaging. This patent describes a packaging cushion comprising a sealed envelope having a gas-permeable panel, and containing separated materials for forming foam, the gas-permeable panel preventing substantial passage of foam or its precursors from the envelope. Typically, the envelope contents are brought together to generate foam and the bag is placed in a shipping container together with an item to be shipped. A second envelope is placed on top so that the item to be shipped is sandwiched between the two foam filled envelopes. The container is closed and the foam conforms to the item to be shipped, and sets. Without the outer container, the cushion would not conform well to the goods; rather it would flow in directions of least resistance before setting. Moreover, in many packaging environments, the cushion and the container would be tailored to the goods for transit. Thus, there would be little chance of generating too much foam in the cushion.

Whilst known foam-in-bag packaging systems recognise the need to vent gases from the bag as the foam forms, there is no provision to cope with the possibility of foam egress. In both US 6695801 and WO 98/46498 polyurethane foams are described and it should be noted that such foams bond strongly to many surfaces including skin. Thus, US 6695801 keeps the bag sealed to avoid contact between the foam and the patient or staff. However, this approach limits the flexibility of such devices and can cause problems of pressure build up. If, for example, when deploying foam-in-bag devices, the space available for the foam is less than the volume the foam will require, then increased pressure will be generated. The increased - A -

pressure may be inappropriate for a body part being immobilised (or an item being packaged) and may cause damage.

It is an object of the present invention to provide an improved body part immobiliser which readily and comfortably adapts to different sizes of body part, which does not contaminate the patient or user with foam or its precursors, and which may offer good infection control by being single-use.

In accordance with a first aspect, the present invention provides a body part immobiliser comprising a flexible envelope, which contours to a body part and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, and means connected to the or each vent for collecting excess foam.

It will be understood that according to the invention the at least one vent is configured to allow for the escape of foam to outside the envelope in normal use of the device and may therefore be distinguished from outlets which are adapted only to allow for the escape of gases resulting from the formation and/or curing of the foam inside the envelope. Preferably the means for collecting excess foam is adapted to completely contain any excess foam which may emerge from the envelope during or after filling. The invention avoids the problem of excess pressure being applied to the body part, especially where e.g. the body part is a broken limb.

In a preferred embodiment the collecting means comprises one or more flexible bag[s] or sleeve[s]. A particularly preferred form comprises one or more bladder(s) attached or secured to the or each vent and communicating therewith. This aspect of the invention can in particular meet the needs of immobilising patients for radiotherapy. The patient's body part is positioned on or against the envelope, or the envelope is arranged around the body part, and the curable foam is introduced to the inside. The foam forms and contours the envelope to the body part. Gases produced by the foaming and any excess foam moves through the or each vent, preferably into the bladderfs]. Once the foam has cured, the bladder[s] may be removed. The invention avoids the possibility of excess pressure or foam not being released from the envelope and causing the envelope to swell; this would either lift the body part or adversely compress it. Further advantageously, the bladder[s] prevent the patient or staff being contaminated by the foam before it is cured. Moreover it will be appreciated that the invention allows for simple production of single-use custom immobilisers, which are more comfortable than known immobilisers. In scanners and radiotherapy treatment, the immobiliser is preferably a custom-fit to a patient and can then re-used for subsequent scans or radiotherapy treatment on that patient. In an emergency situation, the same body immobiliser can be used for different body parts, e.g. the same device may be used for an adult arm or a child's leg, and can adapt to a range of body part sizes, as the envelope will contour to the body part and any excess foam e.g. in the case of a larger limb can be released without applying pressure to the body part. In the case of a leg splint, for example, just two or three different sized devices may cover the whole range of limb sizes likely to be encountered. This can reduce the amount of equipment to be carried by an emergency crew. A body part immobiliser in accordance with the invention can also offer good infection control because it can be single-use. In accordance with a second aspect, the present invention provides a body part immobiliser comprising a flexible envelope, which contours to a body part, has opposing margins, and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, means to secure the margins together and means connected to the or each vent for collecting excess foam.

This aspect of the invention also advantageously avoids the problem of excess pressure being applied to the body part, especially where e.g. the body part is a broken limb. As in the first aspect of the invention, preferably the means for collecting excess foam comprises one or more bladder(s) attached or secured to the or each vent.

This aspect of the invention can in particular meet the need to immobilise patients, for example, in an emergency situation. Before use the device can be stowed in a compact manner. Securing the margins of the device around the part to be immobilised allows the device to be rapidly deployed so that the patient can be moved quickly. The device also provides the flexibility that it can be deployed for different body parts, e.g. the same device may be used for an adult arm or a child leg, and the margins secured so that the body part is sufficiently immobilised for transportation, regardless of some variation in its shape and size. In the case of a leg splint, for example, just three or four different sized envelopes may cover the whole range of limb sizes likely to be encountered. This can reduce the amount of equipment to be carried by an emergency crew.

Again, the envelope will contour to the body part and the release of excess foam and gas from the envelope (e.g. in the case of a larger limb) allows a snug fit to be generated around the body part without the prospect of adversely squeezing the body part. Moreover, providing the bladders to collect excess foam prevents contamination of the patient or staff with uncured foam.

It will be understood that an immobiliser in accordance with the above-described aspects of the invention may be used to immobilise more than one body part. Moreover, the Applicant has appreciated that with regard to paediatric care, especially in the pre-hospital setting, the above aspects of the invention provide a device which can enable a small child to be securely transported by ambulance. Given the small sizes of infants and their lack of understanding, it is very difficult to secure them successfully to an adult stretcher; it is either too distressing for the child or the straps do not make adequate contact. Moreover, neck collars in paediatric sizes are available for suspected neck injuries but, again, it is very distressing for a child to have one put on and it is a very difficult task to accomplish successfully. In preferred embodiments, therefore, the immobiliser is in the form of a support board or stretcher for a child. Such a support board is considered novel and inventive in its own right and thus from a further aspect the present invention provides a support board for a child comprising: a backboard; two or more flexible envelopes, which contour to the child's body and include at least one vent to outside the envelope; means providing a curable foam to the inside of the envelope; and means communicating with the or each vent for collecting excess foam.

This further aspect of the invention also advantageously avoids the problem of excess pressure being applied to the child, especially when injured. As in the previous aspects of the invention, preferably the means for collecting excess foam comprises one or more bladder(s) attached or secured to the or each vent. Excess foam, which may be the case with a larger child, is vented outside the envelopes and preferably collected in the bladder(s).

Preferably the envelopes are removably attached to the backboard. The flexible envelopes may be in the form of custom made cushions which provide good contact around the infant and can effectively form a wall of foam which contains the infant on the support board and limits movement. Preferably side panels are hingedly connected on either side of the backboard. The support board can be strapped to a stretcher and the infant transported to hospital. After the child has been transported to hospital, for example, the side panels can be folded down and the envelopes of foam can be carefully slid away from under the infant. A support board in accordance with this further aspect of the invention may not completely immobilise the child's body parts, but preferably at least restrains the child to a sufficient degree to allow safe transportation. Of course, one or more of the envelopes may be configured to immobilise a particular body part, for example the neck. Otherwise the envelopes will advantageously conform around any dressings or immobilisers already in place.

The envelope(s) in all aspects of the invention is preferably manufactured from any suitable plastics material which is strong enough to withstand potential puncture when being positioned for use and which is relatively inexpensive, thus providing a cost effective single-use device. Such plastics include thermoplastic materials such as polyolefins, polyesters, polyvinyl chloride, acrylic polymers, polycarbonate, nylon, fluoropolymers and polyurethanes. The plastics film for the envelope may be a laminate to gain flexibility with puncture resistance. With a view to reducing the environmental impact of the device once used, a biodegradable plastic may be used, such as one containing polyhydroxybutyrate or one containing an infill in the web such as starch. The walls of the envelope may be of different rigidities, preferably the wall away from the patient being less flexible. In a device of this nature the foam would preferentially deform the wall on the patient side of the device and provide a snug fit. Since the envelope is vented, the foam will flow and mould to the contours of the patient as the wall away from the patient and, where provided, the means for securing opposing margins form a restraint to flow of the foam away from the patient. A benefit to the patient is that the foam conforms to their body part and spreads the forces between that body part and the device. This is in distinct contrast to many of the prior art devices which often rely on relatively small contact points with the body part.

The walls of the envelope may be spot welded together, for example at regular intervals or in particular patterns to enhance fit of the device to the body part. Securing the walls of the envelope in this way leads to a more controlled thickness of foam and a tailored fit. A preferable feature of the invention is the provision of a line of welds in the envelope aligned generally along its midline so that when the device has been deployed and the foam is rigid, the welds may act as a line of weakness or as a hinge to assist in removal of the device. Depending on the body part, one or more line of welds may be preferable so as to further aid removal of the device. Such welds may also assist in alignment of the device on the body part. It will be clear to a person skilled in the art that such welds should not lead to areas of insufficient support or protection for the body part

In relation to a neck brace, it may be preferable to weld a stiffening spar to the midline of the device to assist in correct alignment and fitting/filling. Naturally, the welding of the envelope may provide pockets to receive stiffening spars, which may be advantageous in certain patient presentations. With regard to an immobilisation device according to the invention designed for the neck, it is preferable to provide a rigid chin support, preferably attached to one of the opposing margins. Preferably, the chin support allows access to the carotid pulses and the trachea. In this device it may also be preferable to use a more rigid wall away from the patient and extra material for the wall which will contact the patient. The extra material is preferably pleated in a way which will aid expansion by the foam. A device of this construction for the neck would have the benefit of conforming to a greater range of neck sizes if sufficient foam is made available to fill the gap between the neck of a small patient and the less flexible wall away from the patient. Such a device may be used on a large person and excess foam will be vented, e.g. to fill the one or more bladders. When the device is fitted to a smaller person minimal foam escapes e.g. into the one or more bladders. With regard to an immobilisation device according to the invention designed for a long limb, it is preferable to provide pockets on the side of the envelope away from the patient, which pockets may receive strengthening spars. If the spars are radio opaque then they may be removed for x-ray purposes. The surface of the envelope, which will contact the patient, may have a pliant insulating cover, e.g. foam, to insulate the patient from heat generated by the curable foam. Moreover, a reflective film may also be used to reduce heat transfer towards the item. In this regard it should be noted that most rigid polymer foams are produced by an exothermic reaction and energy is released more quickly the faster the process runs, potentially leading to raised temperatures. However, the energy can be used to turn water briefly into steam, the steam being used to drive expansion and movement of the foam through the envelope. Moreover, it should be noted that thermoset foams are often used for their insulating properties and therefore heat generated will be conducted slowly through the foam towards the patient and the environment. A person skilled in the art of thermoset foams should be readily able to adjust the foam precursors to achieve rapid foam rise and cure with minimal heating problems.

Preferably, the surface of the envelope, which will contact the patient, may have additional bladders inflated with inert gas, e.g. air. These bladders are oriented to align with the limb for a limb device or the neck for a neck device. Once the device had been deployed and the foam cured or set, these bladders may be punctured if there are concerns regarding vascular compromise or if the patient felt the device was too tight. In these circumstances the device could still be retained on the body part, providing immobilisation, yet patient comfort and/or circulation would be maintained.

In accordance with the first aspect of the invention, the envelope may form a cushioning pad which can be placed against or around a body part for immobilisation. A number of such pads may be arranged around a body part or a single pad may be at least partly wrapped around a body part. The pad(s) may preferably be secured in place. The envelope may form part of a device which provides a supporting structure for a body part. In other embodiments, the envelope may be preformed into a shape suitable for receiving a body part. For example, the envelope may be formed as a sleeve for receiving a limb such as an arm or leg. This could allow the device to be easily slid onto the limb before or during formation of the foam. The device may therefore be tailored for use with particular body parts.

In accordance with the second aspect of the invention, the means to secure the opposing margins of the envelope may be, for example, adhesive tapes provided with easy tear-off covers to expose the adhesive, hook and loop fastenings, or lugs and a series of keyhole slots. The securing means can allow a paramedic to adjust the immobiliser according to the patient and to the body part, adapting it to the particular injury as necessary. In the case of a device for use on the neck with a rigid chin support, the chin support may form part of the securing means. It is envisaged that the means providing a curable foam to the inside of the envelope may include a foam precursor packet similar to the arrangement described in US 2004/0209026 or a foam precursor packet may be attached to the envelope via a frangible seal. Preferably, therefore, the means providing a curable foam comprises one or more foam precursor packets, preferably arranged inside the envelope. For a large sized device, it may be preferable to include several precursor packets around the periphery of the envelope to provide a more uniform delivery of foam into the envelope. The foam precursor packets are preferably attached at predetermined locations in order to control the flow of foam in the envelope.

Those skilled in the art of two-component foams will be aware of many other ways of providing the curable foam, for example, a double syringe with a mixer tube or aerosol can feed the envelope directly or via a manifold to deliver foam more evenly to the envelope. The tubing from the manifold would need to be flexible enough for ease of use yet sufficiently rigid to maintain patency, i.e. to maintain an unrestricted inlet to the envelope during filling. Moreover, the length of pipes would need to be regulated to achieve an effective foam fill throughout the device and preferably it should be possible to cut them or disengage them from the rest of the device once the foam has been deployed.

In a hospital setting, it is envisaged that the means providing a curable foam to the inside of the envelope may comprise an external foam dispenser. For example, barrels of the foam precursors may kept at the right e.g. elevated temperature required for reaction and hoses plus an applicator gun provided for filling immobiliser envelopes. Pre-formed sleeves, splints, braces, cushions, etc. could be applied to patients and then a foam gun could be used for filling. Preferably some form of insulation is provided around the foam precursors to maintain their temperature between removal from an ambulance and deployment at an accident scene. Such insulation would limit, the amount the precursors cooled down or warmed up. Thus, foam precursor selection would not have to be varied for summer and winter use or for different climates.

The foam may be any suitable fast curing formulation which does not generate excessive heat and has sufficient rigidity. Foams available in Instapak © Quick and Quick RT bags, available from Sealed Air, have sufficient rigidity and set in an adequate time frame. Selection of foam precursors will be readily apparent to a person skilled in the art. For example, polyurethane foams are typically produced by the reaction of an isocyanate compound with a hydroxyl-containing material, such as a polyol. As with any foaming process, a blowing agent must be used to expand the resultant polymer into a cellular structure. In the case of generating polyurethane foams, water may be mixed with the polyol component or may be otherwise present in the envelope to react with the isocynate compound to produce carbon dioxide which serves as a blowing agent.

In order to maintain water or other liquid components evenly distributed through the envelope, a porous flexible web may be laid between the two sheets which form the envelope, said web preferably extending to the envelope's inner margins. In this case, the foam may be introduced between the porous web and one wall of the envelope. The porous web would effectively form a wall against the foam and the envelope wall on the side of the web away from the foam can merely serve as a barrier to contamination of the patient or crew by foam or its precursors.

The bladder[s] preferably secured or attached to the or each vent is of sufficient size to accommodate any excess foam flowing through the vent. Such foam may be generated e.g. by overfilling the envelope when used on a large patient. In designing the device to fit a range of patient sizes, the bladder size will allow for the difference between small and large patients. For example, for an arm splint immobilising the forearm and hand the device may be provided with bladder[s] having a total volume in the range of about 50-2000 cm³. A preferred limb e.g. arm splint device may comprise two bladders, each having a capacity of about 1000 cm³, and being provided on each side of the device. Such an arrangement would cover a mishap in deployment by accommodating excess foam and still safeguard the patient, medical staff, etc. from contamination with the foam.

The bladder is preferably expandable and may be constructed in a concertina fashion or have gussets or pleats, to keep the device compact while allowing for the escape of a variable amount of foam. The bladder may be formed from extensions of the webs which make the walls of the envelope. The bladder may be made of thin inexpensive plastic and may initially be tacked to the envelope to provide a more easy-to-handle form. Moreover, it is preferable that the bladder, or bladders, may be easily cut or torn from the rest of the device, once the foam has cured, so that the excess foam is not a hindrance e.g. to further care of the patient. In preferred embodiments the bladderfs] is/are therefore separable from the immobiliser. It is preferable that the or each bladder has a semi-permeable membrane which allows for the passage of gases from the envelope via the vent and through the bladder, but stops egress of the foam. Both WO 98/46498 and US 2004/0209026 describe such gas permeable membranes in relation to foam in place packaging. Moreover, the membrane may include activated charcoal to scrub exiting gases in order to minimise the release of vapours.

It will be apparent to a person skilled in the art that the or each vent should be placed so that foam properly fills the envelope before excess escapes into the bladderfs]. Moreover, it will be clear that the size of the or each vent is preferably such that it is small enough to slow flow of foam out of the envelope until the envelope fills sufficiently yet not too small as to cause an adverse build up of pressure in the envelope. These characteristics of the or each vent will be dependent on the properties of the foam such as time to set and viscosity.

According to a further aspect of the invention there is provided a method of immobilising a body part comprising the steps of: arranging against or around a body part a body part immobiliser comprising a flexible envelope, which contours to the body part and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, and means connected to the or each vent for collecting excess foam; and introducing the curable foam into the envelope and waiting for it to set. According to a yet further aspect of the invention there is provided a method of immobilising a body part comprising the steps of: arranging around the body part a body part immobiliser comprising a flexible envelope, which contours to the body part, has opposing margins, and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, means to secure the margins together and means connected to the or each vent for collecting excess foam; securing the opposing margins of the envelope; and introducing the curable foam into the envelope and waiting for it to set. In accordance with both these aspects of the invention, the step of introducing the curable foam into the envelope may be carried out before, during or after arranging the immobiliser against or around the body part. It will be appreciated that the body part immobiliser used in these methods may comprise any of the above-described preferred features. It is preferable that the above methods further comprise the step of deflating bladder(s) located between the patient and the foam filled envelope in order to alleviate pressure on the patient's body. Moreover, it is preferable to remove any bladders containing excess foam once the foam has cured.

When the body part to be immobilised is the neck, it is preferable that the method also includes the step of engaging a chin support with the patient's chin, preferably before introducing the foam.

It will be understood that a body part immobiliser as described herein may be used for both human and animal body parts.

It will be appreciated that many of the advantages and preferred features of a body part immobiliser in accordance with the above-described aspects of the invention could apply equally to the immobilisation, cushioning and/or packaging of a delicate item instead of a body part. The application to packaging is considered novel and inventive in its own right and thus from a further aspect the present invention provides a foam-in-bag device for use in packaging comprising a flexible envelope, which contours to the item to be packaged and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, and means connected to the or each vent for collecting excess foam. From a yet further aspect the present invention provides a foam-in-bag device for use in packaging comprising a flexible envelope, which contours to the item to be packaged, has opposing margins, and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, means to secure the margins together, and means connected to the or each vent for collecting excess foam.

In both of these further aspects of the invention, it is preferable that the means for collecting excess foam is configured to completely contain such foam and may comprise one or more bladder(s) attached or secured to the or each vent, although other forms of flexible containing bag or sleeve may be used.

In accordance with these further aspects of the invention the foam forms and contours the envelope to an item to be packaged, for example delicate glassware. Gases produced by the foaming and any excess foam moves through the or each vent, preferably into the bladder[s]. Once the foam has cured, the bladder[s] may be removed. As with a body part immobiliser, the invention avoids the problem of excess pressure from too much foam. Release of excess gas/foam from the envelope allows a snug fit to be generated around the item being packaged without the prospect of adversely squeezing the item. Moreover, the bladder[s] can prevent contamination by excess foam leaving the envelope before it is cured. The amount of foam which will move into the bladder[s] depends on the size of the item[s] being packaged. The means providing a curable foam to the inside of the envelope may comprise one or more foam precursor packets, preferably arranged inside the envelope, or may comprise an external foam generator.

In a foam-in-bag device for use in packaging it is preferable that the envelope includes an area for writing an address for shipment. From a further broad aspect the present invention provides a cushioning device comprising a flexible envelope, which contours to an object to be cushioned and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, and means connected to the or each vent for collecting excess foam.

It will be understood that any or all of the preferred features described hereinabove with respect to a body part immobiliser will apply equally to a foam-in-bag device for use in packaging or to a cushioning device in so far as they relate to features of the flexible envelope, means providing a curable foam, or means for collecting excess foam, which are common to all aspects of the invention. For example, it will be appreciated that the foam collecting means e.g. bladder(s) being separable from the envelope is a preferred embodiment of the further aspects of the invention set out above. Moreover, except where they are mutually exclusive from a technical point of view, all of the individual features set out hereinabove may be provided in any and all combinations within the scope of the various aspects of the invention. The invention also extends to a method of packaging an item comprising the steps of: arranging around the item a foam-in-bag device comprising a flexible envelope, which contours to the item and includes at least one vent to outside the envelope, means providing a curable foam to the inside of the envelope, and means connected to the or each vent for collecting excess foam; and introducing the curable foam into the envelope. Preferably the method further comprises the step of wrapping the envelope around the item and securing the margins of the envelope together.

As in the previous aspects of the invention, the means for collecting excess foam preferably comprises one or more bladders secured or attached to the or each vent and the method preferably further comprises the step of cutting or tearing away the or each bladder from the device once the foam has cured. The collecting means preferably is configured to contain all excess foam.

The Applicant has appreciated that, in a more automated set-up, it is preferable to have, for example, a system wherein a conveyor receives a first envelope, the item to be packaged is placed on the first envelope and a second envelope is placed on top. A guide along one side of the conveyor provides resistance to movement of foam in that direction and a plate above the conveyor limits upward movement of foam. Thus the forces from the three sides contain and constrain the foam and excess foam is forced towards the vents, and preferably to bladder(s), which are on the open side of the conveyor. Once filled, any bladder(s) are sheared off, by a blade or hot wire for example, as the package continues to progress along the conveyor. It is preferable that means are provided to secure the two formed foam envelopes together. For example, the edges may be taped or fused together. Such a system can provide a protective package free of the need of a cardboard outer which is substantially parallelepiped. This will be a benefit in both costs and compact shipping. When packaging more rigid items the bladder[s] may be dispensed with and both upper and lower envelopes may be conventional foam-in-place packaging. The features which allow a substantially parallelepiped foam-in-bag package to be formed are considered to be novel and inventive in their own right. Thus, from a further aspect the present invention provides a foam-in-bag packaging system comprising a conveyor, means for receiving a first envelope on the conveyor, means for placing an item to be packaged on the first envelope, means for placing a second envelope on top of the item, and guide means for constraining the direction of movement of foam in the envelopes so as to provide a package having a generally parallelepiped form.

Preferably the system further comprises means for removing one or more bladders from the envelopes. Preferably the system further comprises means for securing the envelopes together.

From a yet further aspect the present invention provides a method of packaging an item in a generally parallelepiped form comprising the steps of: deploying a first envelope of a foam-in-bag device; placing an item to packaged on the first envelope; deploying a second envelope of a foam-in- bag device; placing the second envelope on top of the item; and constraining thθ direction of movement of the foam in the envelopes so as to give the package a generally parallelepiped form.

Preferably the method further comprises the step of securing the two foam-filled envelopes together. Some preferred embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:

Fig. 1 shows a first preferred embodiment of a body part immobiliser device for use on a limb, showing the side which will be away from the patient;

Fig. 2 is the stepped section taken at A - A' in Fig.1 ;

Fig. 3 is a view of the device located on a limb with the foam in place and the manifold and bladders removed;

Fig. 4 shows a second preferred embodiment of a body part immobiliser device and gives a schematic view of the side to face the patient;

Fig. 5 is a view taken along line B - B' in Fig. 4;

Fig. 6 is a schematic cross-section showing the second preferred embodiment deployed on a limb; Fig. 7 is a third preferred embodiment of a body part immobiliser device for use on the neck, shown from the side which will contact the patient;

Fig. 8 is a view of the device of Fig. 7, shown from the side away from the patient; Fig. 9 shows another embodiment of a body part immobiliser device for use to stabilise the head and neck;

Figs. 10a and 10b show schematic cross-sections for the device of Fig. 9;

Fig. 11 shows a support board for a child; Fig. 12 shows diagrammatically a production line for manufacturing limb splints; Fig. 13 is a plan view of the welding and cutting station in the production line of Fig. 12;

Fig. 14 shows a preferred embodiment of a foam-in-bag device for use in packaging and posting, showing the side which will be towards the 5 item to be packaged;

Fig. 15 is the section taken at A - A' in Fig. 14;

Fig. 16 shows another preferred embodiment of a foam-in-bag device for use in packaging and posting, showing the side which will be away from the item to be packaged;

I O Fig. 17 is a schematic view showing a bottle being packaged in the device of Fig. 14;

Fig. 18 is a schematic view of a method of packaging items in a box according to another preferred embodiment of the invention; and

Fig. 19 is a schematic view of a conveyor packing arrangement 15 according to an embodiment for forming box-free packages.

The device shown in Figs. 1 to 3 comprises an envelope 1 , bladders 2, securing tapes 3, a manifold 4, and a container 5 of foam precursors. The webs 6 of the envelope 1 are strip-welded at 7 and spot welded at 8. The envelope 1 has vents 9 into the bladders 2 which are themselves vented to 0 air. The bladders are tack welded at points 11 to the envelope and the tapes 3 have protective covers 12. Between the manifold 4 and the container 5 of foam there is a valve 13 to control foam release.

In order to deploy the device, e.g. in an emergency situation, the limb is wrapped in the envelope 1 and the protective covers 12 are removed from 5 the tapes 3, individually, to secure to the opposite side of the envelope 1. At the end with the bladders 2, the tack welds 11 are broken to give easier access for securing the tape 3 and to make it easier for the bladders 2 to fill if necessary. The container with foam 5 is shaken and the foam dispensed on opening the valve 13. As the envelope 1 fills with foam, the ambulance 0 crew watch and close the valve 13 once the foam has reached the vents 9. Any slight delay in closing the valve 13 or movement of foam into the bladders 2 is contained by the bladders and the foam is unable to contaminate the patient or the crew yet the envelope inflates to atmospheric pressure to provide a rigid support. The foam gently presses the side of the envelope against the patient. Once the foam has cured, a matter of seconds, the manifold 4 is simply cut away and the bladders 2 are cut or torn away.

If necessary any gas-filled bladders [not shown], running longitudinally can also be punctured to make sure that there is minimal chance of vascular compromise while the device is place.

The device may remain in place during x-raying as the plastics used are radio translucent. Once a decision has been made to remove the foam filled envelope, the tapes 3 can be cut and the spot welds 8 used to form a hinge to aid removal.

A second embodiment of the invention is shown schematically in Figs. 4, 5 and 6. In this embodiment, gas-filled bladders 14 are attached to the envelope 1 by means of tack welds 15. These bladders 14 are on the side of the envelope which will contact the patient and a cross-section of the device in-situ on a limb 16 is shown in Fig.6. If there are concerns regarding vascular compromise, the device may remain in-situ and the bladders are burst by puncturing their free ends. This makes the space taken up by gas available to the limb and avoids constriction of the limb.

A third embodiment of the invention is shown in Figs. 7 and 8. This embodiment is for immobilising a neck and the envelope 1 is contoured for this purpose, particularly the more rigid wall 17 which faces away from the ^patient. A weld 18 helps to position the device and can later act as a hinge for removal of the device. Foam precursor packets 19 divided by frangible seals 20 are attached to the envelope via frangible seals 21. Bladders 22, which cover vents 23, include semi-permeable membranes 24. A moulded chin support 25 forms the securing means together with tapes 3. A hole 26 is provided to allow access to the trachea when the device is in-situ. To use the third embodiment of the invention, the precursor packs 19 are squeezed rupturing seals 20 and the foam precursors begin to mix. The device is gently slipped into place around the patients neck, the tapes 3 secured to the other margin of the device and the chin support 25 held against the patient's chin. The foam ruptures the seals 21 and enters the envelope 1. The foam fills the envelope and swells to meet the patients neck to give a firm but comfortable support. Any excess foam leaves the < envelope 1 via the vents 23 and enters the bladders 22. Any gas released in foam production not retained in the foam will exit the device via the semipermeable membranes 24.

Fig. 9 shows a device 27 for use to stabilise the head and neck, for instance in a pre-hospital setting or in CT and MRI scanners. A central panel 28 is shaped a one end to fit a patient's upper trunk and is flanked by side panels 29. The side panels 29 link to bladders 30 which have gas exit areas 31 . Walls of the device 27, which lay away from the patient are substantially rigid, are hinged together and the side panels 29 also have straps 32a, 32b and connectors [not shown] to secure the side panels 29 together. The wall towards the patient is flexible and insulated for comfort. Inside the device 27 there is a foam precursor pack or packs [not shown].

In a further embodiment, an envelope according to the invention may be removeably attached to the rigid panels 28,29 by, for example, a repositionable adhesive, such as 3M™ Spray-Mount™. In another embodiment [not shown], the device comprises two envelopes, which meet at the mid-line of the central panel 28 and overlay the side panels in a similar manner as that shown in Fig. 9. In this embodiment, each envelope has its own precursor pack and is preferably attached to the boards 28,29 in a repositionable manner. To deploy the device 27, the central panel 28 is slipped under the patient's head until the shaped end abuts the patient's upper trunk and the precursors are mixed [or can be mixed before positioning if the rate of rise is slow enough]. The side panels 29 are lifted to provide a broadly U-shaped channel, to contain the foam as it forms, and the straps 32 are used with the connectors to secure the side panels 29 to each other. Excess foam will be collected in the bladders 30, which can be torn or cut from the device 27 once the foam has set. The device 27 can be used on both large and small people, the bladders 30 taking any excess foam. Moreover, if the patient has many dressings or a neck immobilising collar in place, the foam will merely flow around such items, as around the neck and head, to stabilise the patient. Also, the device 27 does not force the patient's head and neck to comply with the form of the device. Rather, the foam shapes and conforms to the patient leading to a comfortable custom fit. When the two-envelope version of the device is used, the foam forms two half shells and each half can be carefully removed when examining the patient. This may assist in minimising movement of the patient's neck. In a further development, the lower strap 32a may comprise a chin engaging portion [not shown] and the upper strap 32b is oriented to engage the forehead of a patient. Thus the device can act as an immobilising device on a spine board without the need for an immobilisation collar. If the patient is wearing an immobilisation collar, the lower strap 32a may wrap around under the chin engaging part of the collar to further stabilise the patient's neck.

From a practical perspective, there has to be a balance between the rigidity of the foam for structural stability once the device has been deployed and the comfort value of softer foams for the patient. This balance can be aided by the ratio of sizes of the central panel 28 and side panels 29 as shown diagrammatically in cross-section Fig. 10a and 10b. Fig 10a may be a more rigid foam after deployment and the shape is substantially U-shaped. In Fig. 10b the central panel is wider and the side panels are also a little wider. This leads to a central U-shape of the same dimensions as shown in Fig. 10a, which is buttressed by more foam. The arrangement in Fig.10b would assist in the rigidity of the device 27 when using less rigid foam.

Fig. 11 shows a device 132 for use in stabilising and transporting a child, for instance in an emergency situation. Fig. 11a shows a front view and Fig. 11b shows a rear view. The support board 132 comprises a central panel 134 comprising a rigid backboard about 120cm long, which should accommodate most children up to five years old. Two side panels 136 are preferably hinged thereto along hinge lines 137. The backboard 134 is about 35-40cm wide and the side panels are about 15-20cm deep. Two or more flexible envelopes 138 are attached to the boards, preferably by a repositionable adhesive [such as 3M™ Spray-Mount™], and they are arranged so that they abut on the mid-line 140 of the backboard 134. The envelopes 138 may be pre-attached to the backboard 134 and/or side panels 136. Alternatively, a suitably sized backboard 134 and envelopes 138 may be selected according to the patient, and assembled as needed. For a smaller child the side panels 136 may not be necessary.

The envelopes 138 contain foam precursor packs 142. Alternatively, the foam may be generated externally and introduced into the envelopes 138.

To deploy the device for a child, the side panels 136 are opened out away from the backboard 134, the precursor packs 142 are set off and the child is gently laid on the device 132. The side panels 136 are held up, the foam flows around the child and is constrained by the upstanding side panels 136. The side panels 136 advantageously constrain the movement of foam so that the envelopes contour around the infant and prevent lateral movement of the child. Excess foam, which may be the case with a larger child, is collected in the bladders 144 which communicate with vents leading from the inside of the envelopes 138. The custom made cushion provides good contact around the infant and is effectively a wall of foam which contains the infant and limits movement. The device 132 can then be strapped to a stretcher, if desired, and the infant transported to hospital. Preferably the envelopes 138 are detachable from the backboard. Again, as with the two-part device for head/neck immobiliser, the two envelopes 138 of foam can be carefully slid away from under the infant. The backboard 134 may be re-used, but it is preferred that the device is single-use to provide infection control.

Fig. 12 shows diagrammatically a production line for manufacturing limb splints. A lower web 33, which forms the side of a body immobiliser device which, in use, will be away from the patient, receives precursor packs at station 34. Then upper web 35, which forms the side of the device which, in use, will be next to the patient, is laid. It should be noted that the precursor packs are alternately laid on the left and the right of the lower web 33. An insulation layer is next applied in sections cut from a web 36. Space is left between each sheet of insulation, which should become clear from looking at Fig. 13.

Strips of hook and loop fasteners are preferably applied to the upper and lower webs at stations 37 and 38. When deployed with the device wrapped around a limb, the strips of hook and loop fasteners will overlay and secure opposing margins. Welding and cutting of the splints occurs at station 39.

Fig. 13 is a plan view of the welding and cutting station 39. Two splints are welded and cut for each feed of the webs 33 and 34 and are arranged at 180° to each other. Envelope 40 has bladders 41 , tabs 42, having hook and loop fastener on the upper web 35, and tabs 43 which have hook and loop fastener on the underside on the lower web 34. At 180° to envelope 40 is a just completed splint 44 with bladder 45 and also tabs 42, which are the same orientation as for envelope 40. Splint 46 is only partially formed and on the next advance of the webs 33 and 34 will register at the position of splint 44. Each precursor pack 47 is placed at the end of the envelope opposite to that of the bladders.

The foam-in-bag packaging devices shown in Figs. 14 to 17 comprise an envelope 101 , bladders 102, securing tapes 103, and a two-part container 104 of foam precursors. The webs 105 and 106, of the envelope 101 are strip-welded at 107. The envelope 101 has vents 108 into the bladders 102 which are themselves vented to air by semi permeable portions 109. The securing tapes 103 comprise adhesive 110 which is covered by waxed paper 111. The outer web 106 includes an area 112 for writing a shipping address.

Fig. 17 shows deployment of one such device. The two-part container 104 of precursors is broken and the contents mixed to start formation of the foam. The item to be wrapped, in this instance a bottle, is placed on the envelope 101 and the protective cover 112 is removed from the tape 103, which is then secured to the opposite side of the envelope 101. The amount of foam which moves into the bladder 102 is dependent on the size of the item to be wrapped. Once the foam has cured, a matter of seconds, the bladder 102 is cut or torn away.

5 Fig. 18 is a schematic view of a method of packaging glasses 113 in a box 114 using a lower envelope or cushion 115 and another envelope 116 according to an embodiment of the invention. The envelope 116, like the earlier described embodiments, includes bladders 102 and vents 108, but does not include a securing tape. Depending on the environment, the

I O bladders may be flat packed, rolled [as shown] or folded. In this arrangement the lower cushion 115, which is either according to embodiments of the present invention or may be known from the prior art, is set off and placed in the box to swell. The items to packaged, in this case glasses 113, are arranged on top of cushion 115. The upper cushion is

15 provided by an envelope 116 according to the invention. Preferably the outer wall of the envelope 116 away from the glasses 113 or other item to be packaged is less flexible than the inner wall. The precursors are mixed, the foam begins to form and the envelope 116 is placed over the glasses 113 and the box leaves are folded over to close the box. Whether the placement 0 of glasses 113 is slow or fast and whether they are big or small, the leaves of the box 114 can be folded down leaving space via cut outs 117 for the bladders 102 to fill. Once the foam is cured, the bladders can be detached by tearing them off or cutting them off. By having excess foam leave the box, the blowing pressure for forming the foam is dissipated and cannot 5 crush the fragile items for shipment. If the excess foam did not leave the box, the pressure would build up and break the glasses 113 or distort the box 114.

Fig. 19 is another schematic view of a method of packaging according to an embodiment of the invention. A conveyor belt 118 passes a set of 0 stations, viz: a first envelope deployment and placing station 119, a goods to be shipped placement area 120, and a second envelope deployment and placing station 121. The conveyor 118 then passes under a plate 122 which has a side plate [not shown] on the side conveyor 118 opposite the stations 119, 120, and 121. To the other side of the plate 122 are bladder detaching means 123 and a collection area 124 for the detached bladders 102. Downstream of the plate 122 is a strapping/banding machine 125 and a finished package collection station 126. In this arrangement, a first envelope is deployed at station 119 and placed on the conveyor 118. This envelope may be according to embodiments of the present invention or may be a prior art foam-in-bag envelope. As the foam swells, the envelope passes to station 120 where items to be shipped are placed on the first envelope. This part package continues its journey on the conveyor 118 to station 121 , where an envelope according to the invention is deployed and placed on the part package. This collection of envelope and goods passes under the plate 122 which, together with the conveyor 118 below and the vertical side plate mentioned above, constrain the foam's direction of movement and leads to a generally parallelepiped form. The bladders 102 are removed by means 123, which may be a blade or a hot wire for example, and are collected at the station 124. The package continues its journey on the conveyor 118 to the strapping/banding machine 125 which applies straps/bands to firmly hold the two foam-filled envelopes together. Finished packages are collected at station 126.

In the arrangement shown in Fig. 19 the stations 119, 120, and 121 may rely on human effort or may be semi or fully automated. In a semi or fully automated arrangement it is envisaged that the envelopes are formed at stations 119 and 121 and that foam precursors are injected into the envelope. The arrangement described in relation to Fig. 19 produces protectively packaged goods in a generally parallelepiped form without the use of a box. Indeed, to further constrain the foam, the conveyor 118 may include transverse upstanding plates which define package forming spaces on the conveyor 118. When packaging more rigid items the bladderfs] may be dispensed with and both upper and lower envelopes may be conventional.

Claims

1. A body part immobiliser comprising a flexible envelope which contours to a body part and includes at least one vent to outside the

5 envelope, means for providing a curable foam to the inside of the envelope, and means communicating with the or each vent for collecting excess foam

2. A device as claimed in claim 1 , further comprising means for securing the envelope against or around a body part in use.

I O

3. A device as claimed in claim 2, wherein the flexible envelope has opposing margins and further comprising means to secure the margins together around a part to be immobilised in use.

15 4. A device as claimed in claim 2 or 3, wherein said securing means and/or outer wall of the envelope form a restraint to flow of foam away from the body part.

5. A device as claimed in any preceding claim, wherein the means for 0 collecting excess foam comprises one ormore bladders secured or attached to the or each vent.

6. A device as claimed in claim 5, wherein the or each bladder is expandable. 5

7. A device as claimed in claim 5 or 6, wherein the or each bladder is secured externally to the envelope.

8. A device as claimed in claim 7, wherein the or each bladder is 0 separable or removable from the envelope.

9. A device as claimed in any of claims 5 to 8, wherein the or each bladder is formed from extensions of webs which make the walls of the envelope.

10. A device as claimed in any of claims 5 to 9, wherein the or each bladder has a semi-permeable membrane which allows for the passage of gases out of the envelope through the bladder(s) via the vent(s), but stops egress of the foam from the bladder(s).

11. A device as claimed in claim 10 wherein the membrane includes means such as activated charcoal to scrub exiting gases.

12. A device as claimed in any preceding claim, wherein the envelope comprises a flexible plastics material.

13. A device as claimed in any preceding claim, wherein the walls of the envelope are of different rigidities.

14. A device as claimed in claim 13, wherein the inner wall of the envelope which faces the body part in use is less rigid than the outer wall of the envelope which faces away from the body part in use.

15. A device as claimed in any preceding claim, wherein the walls of the envelope are spot welded together.

16. A device as claimed in any of claims 1 to 14, wherein the walls of the envelope are welded together by one or more weld lines.

17. A device as claimed in claim 16, wherein a weld line is aligned generally along the midline of the envelope.

18. A device as claimed in claim 16 or 17, wherein the or each weld line acts as a line of weakness or as a hinge.

19. A device as claimed in any preceding claim, wherein a stiffening spar is welded to the midline of the device.

20. A device as claimed in any preceding claim, further comprising one or more pockets on the wall of the envelope facing away from the body part in use, which pockets may receive strengthening or stiffening spars.

21. A device as claimed in claim 20, wherein the envelope is welded so as to provide said one or more pockets.

22. A device as claimed in any preceding claim, wherein the wall facing the body part in use comprises expandable material.

23. A device as claimed in any preceding claim, wherein the wall facing the body part in use is pleated.

24. A device as claimed in any preceding claim, wherein the surface of the envelope contacting the body part in use comprises a pliant insulating cover to insulate the body part from heat generated by the curable foam.

25. A device as claimed in any preceding claim, further comprising a reflective film to reduce heat transfer towards the body part in use.

26. A device as claimed in any preceding claim, wherein the surface of the envelope contacting the body part in use comprises additional bladders inflated or inflatable in use with gas.

27. A device as claimed in claim 26, wherein said additional bladders are oriented to align with the body part in use.

28. A device as claimed in any preceding claim, wherein the means for providing a curable foam to the inside of the envelope comprises one or more foam precursor packets.

29. A device as claimed in claim 28, wherein the or each foam precursor packet is attached to the envelope via a frangible seal.

30. A device as claimed in claim 28 or 29, wherein one or more foam precursor packets are arranged around the periphery of the envelope.

31. A device as claimed in claim 28, 29 or 30, further comprising insulation means around the foam precursor packets.

32. A device as claimed in any preceding claim, wherein the foam is a thermoset foam.

33. A device as claimed in any preceding claim configured for use in immobilising the neck and further comprising a rigid chin support.

34. A device as claimed in claim 33, wherein the chin support allows access to the carotid pulses and the trachea.

35. A device as claimed in claim 33 or 34, wherein the chin support forms part of a means for securing the envelope around the neck.

36. A device as claimed in any of claims 1-32 configured as a support board or stretcher for a child.

37. A support board for a child comprising: a backboard; two or more flexible envelopes, which contour to the child's body and include at least one vent to outside the envelope; means providing a curable foam to the inside of the envelope; and means communicating with the or each vent for collecting excess foam.

38. A device as claimed in claim 36 or 37 wherein the envelopes are removably attached to the backboard.

39. A device as claimed in claim 36, 37 or 38, further comprising side panels hingedly connected on either side of the backboard.

40. A method of immobilising a body part comprising the steps of: arranging against or around the body part a body part immobiliser comprising a flexible envelope, which contours to the body part and includes at least one vent to outside the envelope; providing a curable foam to the inside of the envelope; containing excess foam in collecting means communicating with the or each vent; and waiting for the foam to set.

41. A method as claimed in claim 40, further comprising the step of securing together opposing margins of the envelope.

42. A method as claimed in claim 40 or 41 , further comprising the steps of arranging the immobiliser around a patient's neck and engaging a chin support with the patient's chin before introducing the foam.

43. A method as claimed in claim 40, 41 or 42, further comprising the step of deflating bladders located between the body part and the foam filled envelope in order to alleviate pressure on the body part.

44. A method as claimed in any of claims 40-43, further comprising the step of removing the or each bladder containing excess foam.

45. A foam-in-bag device for use in packaging comprising a flexible envelope which contours to an item to be packaged and includes at least one vent to outside the envelope, means for providing a curable foam to the inside of the envelope, and means communicating with the or each vent for collecting excess foam.

46. A cushioning device comprising a flexible envelope which contours to an item to be cushioned and includes at least one vent to outside the envelope, means for providing a curable foam to the inside of the envelope, and means communicating with the or each vent for collecting excess foam.

47. A device as claimed in claim 45 or 46 in which the device has any of the features recited in any of preceding claims 2-18, 22-25, or 28-32, wherein any reference to a body part is replaced with a reference to an item to be packaged or cushioned.

48. A device as claimed in claim 45 or 46, wherein the means for collecting excess foam comprises one or more bladders secured or attached to the or each vent.

49. A device as claimed in claim 48, wherein the or each bladder is expandable.

50. A device as claimed in claim 48 or 49, wherein the or each bladder is secured externally to the envelope.

51. A device as claimed in claim 50, wherein the or each bladder is separable or removable from the envelope.

52. A device as claimed in any of claims 48 to 51 , wherein the or each bladder is formed from extensions of webs which make the walls of the envelope.

53. A device as claimed in any of claims 48 to 52, wherein the or each bladder has a semi-permeable membrane which allows for the passage of gases out of the envelope through the bladder(s) via the vent(s), but stops egress of the foam from the bladder(s).

54. A method of packaging an item comprising the steps of: arranging next to or around the item a foam-in-bag device comprising a flexible envelope which contours to the item and includes at least one vent to outside the envelope; providing a curable foam to the inside of the envelope; and containing excess foam in collecting means communicating with the or each vent.

55. A method as claimed in claim 54, frther comprising the step of wrapping the envelope around the item and securing margins of the envelope together.

56. A method as claimed in claim 54 or 55, wherein the means for collecting excess foam comprises one or more bladders communicating with the or each vent and further comprising the step of cutting or tearing away the or each bladder from the envelope once the foam has cured.

57. A foam-in-bag packaging system comprising a conveyor, means for receiving a first envelope on the conveyor, means for placing an item to be packaged on the first envelope, means for placing a second envelope on top of the item, and guide means for constraining the direction of movement of foam in the envelopes so as to provide a package having a generally parallelepiped form.

58. A packaging system as claimed in claim 57, further comprising means for removing one or bladders from the envelopes.

59. A packaging system as claimed in claim 57 or 58, further comprising means for securing the envelopes together.

60. A method of packaging an item in a generally parallelepiped form comprising the steps of: deploying a first envelope of a foam-in-bag device; placing an item to packaged on the first envelope; deploying a second envelope of a foam-in-bag device; placing the second envelope on top of the item; and constraining the direction of movement of the foam in the envelopes so as to give the package a generally parallelepiped form.

61. A method as claimed in claim 60, further comprising the step of securing the two foam-filled envelopes together.