WO2014080222A1

WO2014080222A1 - A temperature altering device

Info

Publication number: WO2014080222A1
Application number: PCT/GB2013/053096
Authority: WO
Inventors: Wendy Matthews; Lewis Green
Original assignee: W & D Minks Limited
Priority date: 2012-11-23
Filing date: 2013-11-25
Publication date: 2014-05-30
Also published as: GB201221098D0; EP2922512A1

Abstract

A temperature altering device for the treatment of nose bleeds comprising a cooling or heating pad having a facing surface for placement against, and effective to cool, the nose of a patient, and gripping jaws extending around and engaging with the cooling or heating pad which are operable to urge the cooling or heating pad facing surface against the nose of a patient, wherein the gripping jaws have a plurality of user selected fixing positions corresponding to different degrees of jaw closure around the cooling or heating pad and therefore against the nose of the patient in use.

Description

A TEMPERATURE ALTERING DEVICE

The present invention relates to a temperature altering device, in particular a cooling or warming device for treating the nose and a method of using the same.

A common problem in the medical field is the treatment of non-emergency injuries in emergency departments. These non-emergency injuries often have a low priority but can cause congestion, thereby increasing waiting times for higher priority injuries and adding to the treatment and administrative burden of hospital staff.

One such typically non-emergency injury is a nosebleed. When a patient attends a hospital with a nosebleed, if the nosebleed cannot be stopped by traditional means of pinching, doctors often have to plug the nostril of the patient. Plugging the nostril involves an invasive step of placing absorbent materials into the nostril of the patient. Once any such invasive treatment has occurred, the patient must be admitted to the hospital incurring administrative costs, and delays to patient throughput. Furthermore, once the nostril has been plugged it is difficult to remove it without causing further bleeding, and the patient must wait until the plug is effective whilst foregoing better treatment such as that of cautery. Cautery is the procedure of stemming a nosebleed by chemically burning the broken vessel using, for example, a silver nitrate tip. This procedure is quick and effective but requires an expert to administer, and therefore is rarely given before the patient needs to have his nostril plugged, after which it is not practical to remove the plug to cauterise.

It is known that methods of preventing bleeding typically rely on promoting clotting of the blood. Clotting of the blood can be promoted by cooling and by pressure (as well as by gravity). Recently it has further been discovered that the application of some warmth can also promote clotting (Hot water irrigation as treatment for intractable posterior epistaxis in an outpatient setting, Novoa et al, J Laryngol Otol. 2012 Jan;126(1):58-60). Currently, there are cooling devices available that can be positioned on the nose of a patient in an attempt to stop 30 a nosebleed from persisting. Such cooling devices are often not tailored specifically to the nose and therefore effect cooling and patient discomfort on a much larger area than necessary. Even if the devices are tailored to the nose, they are often secured to the face of the patient by cumbersome bands around the head which cannot provide enough localised pressure to stop the bleeding. Alternatively, such devices are held in position with the patient's hand which is not practical for those patients who are frail or weak.

Other devices are adapted to pinch the nose without providing any cooling effect. These devices are typically non-adjustable, and in such devices the level of pressure may be inaccurate and often painful, especially if the patient has an injury to the nose. Furthermore, such devices can cause pressure necrosis after prolonged use resulting in damage to the tissues around the nose.

It is therefore an object of at least some of the aspects of the present invention to overcome these problems and provide an improved temperature altering device for the nose of a patient.

According to a first aspect of the present invention there is provided a temperature altering device for the treatment of nose bleeds comprising a temperature altering pad having a facing surface for placement against, and effective to cool, the nose of a patient, and gripping jaws extending around and engaging with the cooling or heating pad which are operable to urge the cooling or heating pad facing surface against the nose of a patient, wherein the gripping jaws have a plurality of user selected fixing positions corresponding to different degrees of jaw closure around the cooling or heating pad and therefore against the nose of the patient in use.

Generally, it will be appreciated that the cooling or heating pad and gripping jaws are suitably shaped and sized to be placed against the nose of a patient for pinching engagement therewith effective to prevent or reduce blood flow therefrom. Preferably, although the temperature altering device is appropriately dimensioned for use on an injured nose of a human or animal body, the temperature altering device may also be appropriately dimensioned for use on any elongate member of the human or animal body in need of cooling treatment, for example to reduce post operative swelling in members such as the fingers or toes. The gripping jaws preferably comprise a first and a second jaw.

Preferably the first and second jaws are substantially symmetrical with respect to each other. Preferably the first and second jaws together as the gripping jaws form a shape which is economically suited to conform to a human or animal nose. Preferably, therefore, the first and second jaws comprise an elongate section that extends up the nose, generally from the tip, towards the forehead nasion region. Still more preferably, therefore, the gripping jaws form an approximate saddle shape.

The temperature altering device may comprise an inner and an outer portion. The inner and outer portions can have complementary shapes, e.g. complementary U-shapes.

Preferably the first and second jaws are substantially symmetrical with respect to each other. The first and second jaws may be connected via a bridge section. In use, the bridge section may sit substantially over the bridge of the patient's nose, in use.

The angle of the gripping jaws is preferably adjustable between the user selected fixing positions.

Advantageously, relative movement of the outer portion with respect to the inner portion adjusts the degree of closure of the gripping jaws. This has been found to be a particularly user-friendly and effective way of adjusting the degree of closure,

The adjusting mechanism may located in, or in the region of, the bridge section of the gripping jaws. Alternatively, the adjusting mechanism is located in the region of the lower ends of the gripping jaws. The inner and outer portions may be arranged to be biased for movement away from each other and the adjusting mechanism may resist this movement.

The outer portion may be depressed onto the inner portion to adjust the angle of the gripping jaws.

The adjusting mechanism may be a ratchet mechanism. The inner and outer portions can be connected via the ratchet mechanism. The ratchet mechanism may be in accordance with any known mechanical ratchet and typically comprises at least an engaging means, a pawl, and a base.

The ratchet mechanism may comprise a pawl mounted on the inner portion and an engaging means on the outer portion, or vice-versa. The ratchet mechanism may permit relative movement in one direction only. The engaging means may be operable to engage the pawl of the ratchet mechanism.

A guide arrangement may be provided between the inner and outer portions. The guide arrangement can comprise a male sliding portion on one the inner and outer portions and a female sliding portion on the other of the inner and outer portions. Preferably the first and second jaws each comprise a recessed area or high friction area on the outer surface thereof which is appropriately dimensioned to receive a finger and/or thumb of a user. Preferably the recessed area is positioned substantially in the centre of the surface of each jaw and provides an aid for finger placement when positioning the device upon the nose of a patient. Optionally the recessed area may further comprise a non-slip material to prevent slippage of the fingers and/or thumb when placing the device upon the nose of a patient. Preferably the non-slip material is one of rubber, plastic, silicone, or a surface pattern located substantially in the recessed area. A third recessed or high friction area may be provided on the bridge to provide an aid for finger placement when positioning the device upon the nose of a patient

Preferably the first and second jaws comprise a distal edge and a proximal edge. Preferably the first and second jaws are connected at their respective distal edges to form the gripping jaws. More preferably the first and second jaws are connected at their respective distal edges to form the gripping jaws via a bridge section. Preferably, in use, the bridge section sits substantially over the bridge of the patient's nose between the distal edges of the first and second jaws. Accordingly, the gripping jaws preferably form a substantial V or U shape in cross section. More preferably the gripping jaws form a substantial U shape in cross section which is economically suited to the shape of the nose such as, for example, by having a curved inner face for close fitting conformity with the bridge of a patient's nose at the bridge section.

Preferably the bridge section extends upwards of the bridge of a patient's nose into the forehead nasion region. Preferably therefore the bridge section comprises a flanged portion, the flanged portion being operable to sit substantially flat against the forehead nasion region.

The gripping jaws are preferably formed from any suitable polymeric material. More preferably the gripping jaws are formed from a polymeric material that is rigid at ambient temperature. Still more preferably the gripping jaws are formed from a solid medical grade polymeric material such that the gripping jaws are both inflexible and hygienic. Alternatively, the gripping jaws, especially jaws of the inner portion, may be formed from a polymeric material that is resilient at ambient temperature. Suitable polymers include, but are not limited to: polyethylene, polyvinylchloride, polypropylene, polyacrylates and suitable copolymers thereof etc.

The first and second jaws may be parallel, at an acute, or at an obtuse angle with respect to each other, in use. Preferably the angle of the gripping jaws is adjustable between the user selected fixing positions. Preferably the user selected fixing positions correspond to degrees of jaw closure ranging from a maximum of 180 degrees to a minimum of 30 degrees. Preferably the user selected fixing positions are positioned at between 5 to 30 degree intervals of jaw closure between the maximum of 180 degrees and the minimum of 30 degrees. More preferably, the user selected fixing positions are positioned at between 5 to 10 degree intervals of jaw closure between the maximum of 180 degrees and the minimum of 30 degrees. Preferably, the engaging means of the ratchet mechanism may comprise a gear. Preferably the gear is generally circular in section with suitably circumferentially spaced radially outwardly projecting teeth. . Preferably the teeth are equally circumferentially spaced around the periphery of the gear, more preferably the teeth are disposed at equivalent to between 5 and 30 degree intervals around the circumference of the gear, most preferably, between 5 and 10 degree intervals. . The arrangement of the teeth preferably includes uniform depressions between the teeth. Suitably the depressions are operable to engage the pawl of the ratchet mechanism.

Preferably therefore the user selected fixing positions of the gripping jaws are determined by the position of the teeth on the gear of the engaging means.

In one embodiment, the depressions may further comprise a non-slip material. Preferably the non-slip material is positioned at the base of the depressions in order to grip the pawl when it is engaged. Such non-slip materials include, but are not limited to: rubber, plastics, fabrics etc.

The engaging means may be associated with either the first or second jaw of the gripping jaws, in one preferred embodiment the engaging means is integral with the first jaw of the gripping jaws. Preferably therefore, the gear is an integrally formed component of the distal edge of the first jaw. Generally the base is fixed to the other jaw and the pawl is attached thereto for relative movement with respect to the gear. Typically, the gear is also fixed to the base in the usual manner familiar to the skilled person in ratchet mechanisms. Advantageously, the fixing of the base on one jaw to the gear of the other jaw serves the dual purpose of connecting the relative jaws and attaching the gear to the base of the ratchet. Preferably, therefore, the first pivot of the ratchet is positioned proximal to the distal edge of the second jaw and connects the distal edge of the second jaw to the centre of the gear on the first jaw. Preferably, therefore, the second pivot of the ratchet is spaced from the distal edge of the second jaw and connects the second jaw to the widened end of the pawl. Preferably the base and the pawl are tensioned in the usual manner.

Preferably the spring is positioned around the second pivot of the base. Alternatively the spring may be positioned between the elongate member of the base and the click member. In use, the gripping jaws are operable to receive pressure from a user of the temperature altering device of the present invention. The pressure may be applied by the user's fingers onto the recessed areas of the gripping jaws. The pressure may be applied simultaneously onto the first and second jaw of the gripping jaws in a pinching movement to facilitate closure of the gripping jaws.

Preferably the first jaw of the gripping jaws is substantially fixed relative to the gear, whereas the second jaw of the gripping jaws is rotatable relative to the gear. Preferably therefore the second jaw is movable with respect to the gear and the first jaw is substantially fixed with respect to the gear. Typically, with respect to the base, the reverse is the case.

Preferably the user applied pressure on the gripping jaws extends the spring between the pawl and second jaw. Preferably, the extension of the spring pulls the pawl over the teeth of the gear on the first jaw. Suitably the number of teeth the click member is pulled over corresponds to a certain number of user selected fixing positions at defined degrees of closure of the gripping jaws, and thereby a narrowing of the angle between the first and second jaw. Preferably the angle is narrowed between a maximum of 180 degrees to a minimum of 30 degrees. More preferably the angle is narrowed to a minimum degree of jaw closure defined by the shape of the patient's nose to which the temperature altering device is being attached.

It will be appreciated that the pawl is permitted to move in one direction over the teeth of the gear until it can no longer do so by abutment against the nose of the patient, yet is prevented from moving in an opposing direction over the teeth of the gear by abutment against the abutting portion of the teeth. Accordingly the temperature altering device is gripped against the nose of the patient.

It is envisaged that the temperature altering device of the present invention may comprise alternative or further adjusting mechanisms, for example, the adjusting mechanism may comprise alternative or further ratchet mechanisms.

In a particularly preferred embodiment of the present invention, the temperature altering device may comprise two ratchet mechanisms. In such an embodiment the two ratchets are preferably positioned at either side of the bridge section of the gripping jaws. Preferably the ratchet mechanisms are configured such that the first and second jaws each respectively provide the base for one of the ratchet mechanisms, and the bridge section of the gripping jaws provides the engaging means for both ratchet mechanisms. Accordingly, the first and second jaws are both permitted to rotate relative to the bridge section. Alternatively, the adjusting mechanism may comprise a non-elastically deformable material and therefore the user selected fixing positions are determined by the pressure applied to the gripping jaws. Preferably the non-elastically deformable material is present as a strip of material between the first and second jaw of the gripping jaws. Preferably the non-elastically deformable material is present as a strip of material between the distal edges of the first and second jaw of the gripping jaws. The non-elastically deformable material may be any suitable material including, but not limited to: plastics, metals or silicones.

In use, preferably the user applies pressure to the gripping jaws, and the non-elastic deformable material therebetween deforms facilitating the closure of the gripping jaws. More preferably the user applies pressure to the gripping jaws until a minimum degree of jaw closure defined by the shape of the patient's nose is reached. Preferably once the user releases the gripping jaws the non-elastic deformable material stays in the same user selected fixing position. Advantageously, the use of a non-elastically deformable material allows the user selected fixing positions to be a continuous scale wherein the gripping jaws can be set to any degree of closure not limited to defined positions. This allows a greater level of fine control over the relative positions of the jaws. In a further alternative embodiment, the adjusting mechanism may comprise a hinge.

Preferably the hinge is an articulated hinge wherein the articulated hinge comprises a plurality of articulations, preferably therefore the user selected fixing positions are defined by the articulations. Preferably the articulations are formed from a plurality of folds in the material of the hinge such as a concertinaed hinge. Preferably the articulated hinge is a living hinge.

Preferably the articulations are at defined intervals apart. Preferably the intervals of the articulations are defined by the various user selected fixing positions required, and thereby the angles of jaw closure required. Preferably the articulations are at intervals which provide user selected fixing positions at least every 5 to 30 degrees of jaw closure, more preferably at least every 5 to 10 degrees of jaw closure. Preferably the minimum degree of jaw closure defined by the fixing positions is 30 degrees, and suitably the maximum degree of jaw closure is 180 degrees, wherein the hinge is not bent and the first and second jaws are flat. Suitable materials for forming such a hinge include but are not limited to; deformable plastics such as polystyrene, polypropylene; or deformable metals such as steel, aluminium.

Preferably, therefore when the hinge is bent, the material deforms.

Preferably the hinge is located between the first and second jaw of the gripping jaws, more preferably between the distal edges of the first and second jaw of the gripping jaws.

Suitably, in use, the user applies pressure to the first and second jaw of the gripping jaws in order to bend the hinge which thereby spreads the articulations and deforms the hinge material. Preferably the number of articulations deformed corresponds to a certain number of fixing positions at defined degrees of closure of the gripping jaws, and thereby a narrowing of the angle between the first and second jaw. Preferably the angle is narrowed between a maximum of 180 degrees to a minimum of 30 degrees. More preferably the angle is narrowed to a minimum degree of closure defined by the shape of the patient's nose to which the temperature altering device is being attached.

Preferably, once the user pressure is released from the gripping jaws, the hinge material stays deformed and remains held at a defined fixing position. Accordingly the temperature altering device is gripped against the nose of the patient.

The temperature altering pad preferably comprises an envelope which is filled with a coolant or heating substance. Preferably the envelope is a sealed container comprising the coolant or heating substance. Advantageously, the coolant or heating substance is contained within the envelope such that the coolant or heating substance is sterile, as compared with many current devices, where the coolant is a separate component that is subject to contamination when cooling and transferring to the device.

In embodiments where a coolant is used, the coolant may be composed of any material with a high specific heat capacity capable of absorbing heat. Preferably the coolant is one of the following non-limiting examples: ice; water; refrigerant gel; Deepfreeze ®; hydroxyethylcellulose; silicon; phase change materials; or a mixture of the same. Preferably the coolant is cooled prior to application of the cooling device to the patient. More preferably the coolant is cooled by any traditional cooling device such as a fridge, freezer, vacuum etc. or in situ by an endothermic reaction contained within the pad.

Preferably the coolant within the pad is non-toxic. The coolant may be mixed with any number of additives to adjust the cooling properties of the cooling pad. Preferably, the minimal temperature to which the cooling pad can reach may be adjusted to provide a varying range of cooling pads for use with the cooling device of the present invention.

Optionally, the temperature altering device of the present invention may be operable to heat rather than cool. Advantageously, it has recently been found that the application of a small amount of warmth can help promote clotting and stop nosebleeds (see reference above). Therefore, optionally the pad may be a heating pad rather than a cooling pad and the device may be a heating device instead of a cooling device. Therefore, optionally, the pad may comprise an envelope which is filled with a heating substance as explained above for the coolant.

The heating substance may be composed of any thermally conductive material capable of radiating heat. Preferably the heating substance is one of the following non-limiting examples: water; Deepheat ®; silicon; phase change materials; or a mixture of the same. Preferably the heating substance is heated prior to application of the heating device to the patient. More preferably, the heating substance is heated by any traditional heating means such as a microwave, oven, waterbath, etc. or in situ by an exothermic reaction contained within the pad.

The envelope is preferably a sealed container capable of storing the coolant or heating substance. Preferably the envelope is composed of any plastic. Preferably the envelope is composed of flexible plastic. More preferably the envelope is composed of medical grade flexible plastic. Suitable plastics include, but are not limited to: polypropylene, polyethylene, polyvinylchloride etc.

Preferably the envelope is composed of a material which does not cause ice burn, for example a material with a low surface friction.

Suitably the envelope comprises two sheets of material as described above which are sealed together at the peripheral edges to form an envelope. Preferably the two sheets of material are also connected across the body of the envelope by a plurality of connecting means, wherein the connecting means may comprise any suitable connecting device such as, but not limited to: studs, staples, punches, or heat conjugated portions of one or both sheets of the material. Optionally the connecting means may be positioned such that the envelope is connected at a plurality of points which define regions of the envelope wherein coolant or heating substance may be contained. Alternatively, the connecting means may be positioned such that the envelope is connected at a plurality of rows and/or columns which define cells of the envelope where the coolant or heating substance may be contained. Advantageously creating regions or cells of the envelope where the coolant or heating substance may be contained avoids pooling and sagging of the cooling or heating pad created when the coolant liquefies as the device is being used.

Preferably the cooling or heating pad is of a size substantially equivalent to the surface area of the nose. More preferably the cooling or heating pad is of a size which does not substantially extend beyond the gripping jaws of the temperature altering device. Preferably the cooling or heating pad is of a shape that provides maximum coverage to the surface of the nose. More preferably the cooling or heating pad is of a shape that economically matches the shape of the nose. Preferably, therefore, the cooling or heating pad comprises an elongate section that extends up the nose, generally from the tip, towards the forehead nasion region. Still more preferably, therefore, the cooling or heating pad is an approximate saddle shape.

Preferably the cooling or heating pad comprises a facing surface and engaging surface wherein the facing surface is operable to be placed against, and is effective to cool, the nose of the patient, and the engaging surface is operable to engage the gripping jaws.

Preferably, the cooling or heating pad is positioned on the proximal side of the gripping jaws of the temperature altering device.

Preferably the cooling or heating pad is connected to the gripping jaws by a fixing means. The fixing means may be any suitable connector or adhesive, such as, for example; glue, tape, poppers, staples, hook and pile, heat sealing etc. Preferably the fixing means is present on the engaging surface of the cooling or heating pad.

In a particularly preferred embodiment, the cooling or heating pad may be connected to the gripping jaws by means of hook and pile such that the cooling or heating pad is removable. This may have the advantage that the gripping jaws can be provided with different pads to allow the temperature altering device to be tailored to different patient's needs. For example, different coolants or heating substances or different shaped cooling or heating pads may be desirable.

Alternatively, the cooling or heating pad may not be connected to the gripping jaws such that different cooling or heating pads may easily be used or replaced. Advantageously, therefore, the gripping jaws may be provided for use with any available cooling or heating pad. In use, the cooling or heating pad is preferably in contact with the patient's nose on the proximal side of the gripping jaws on its facing surface. Preferably this occurs when the user applies pressure to the gripping jaws. More preferably this occurs when the second jaw has been moved as far as possible within the adjusting mechanism such that the temperature altering device is gripping the patient's nose and the gripping jaws are in a user selected fixing position. Preferably, therefore, the cooling or heating pad sits between the nose and the gripping jaws in use.

Advantageously, in use, the cooling or heating pad flexibly conforms to the shape of the patient's nose on the proximal side of the first and second jaw of the gripping jaws. This provides a snug fit to of the pad to the nose and simultaneously applies even pressure and a cooling effect over the nose giving a far more efficient way of treating nose injuries.

Optionally, the temperature altering device of the present invention may further comprise a release mechanism.

Preferably the release mechanism is operable to release the one or more adjusting mechanisms holding the gripping jaws in position. In an embodiment where the adjusting mechanism is a ratchet mechanism, suitably the release mechanism is a user-actuated lever. Suitably, the lever acts to remove the pawl from the engaging means of the ratchet mechanism by removing the pawl from the engaging means of the ratchet mechanism. Preferably the lever removes the pawl from the engaging means by use of the second pivot. More preferably the lever removes the pawl from the engaging means by a turning moment around the second pivot.

Preferably, therefore, the lever is an extension of the pawl.

After use of the temperature altering device of the present invention, preferably the lever is used to release the ratchet mechanism and reset the temperature altering device. Furthermore the lever may also be used to remove the temperature altering device from a patient's nose.

In an alternative embodiment, the temperature altering device may not comprise a release mechanism. In such cases, where the adjusting mechanism is a ratchet mechanism, preferably the temperature altering device is a one-use device because the ratchet mechanism cannot be reset. In other cases, where the adjusting mechanism is a non elastically deformable plastic, or hinge, preferably the temperature altering device is removed by the user applying pressure to the gripping jaws in an opposing direction to that originally applied to grip the patient's nose. Alternatively, the where the temperature altering device is a cooling device, it may be removed from the patient by a reduction in viscosity of the coolant within the cooling pad as the temperature of the coolant is slowly raised. Preferably, the coolant is ice such that melting of the ice to water allows the cooling device to be removed. Advantageously, this provides an easy means for the user to determine when the treatment with the cooling device of the present invention is finished. Furthermore, different coolants with different melting points may be employed within various cooling pads such that the treatment time can be varied by the use of a different cooling pad.

Advantageously, the adjusting mechanism allows the temperature altering device to be adjustable to any patient's nose and to any level of pressure. Once treatment is finished, the temperature altering device may be released. Optionally, the gripping jaws may then be reset to allow the temperature altering device to be reused.

Crucially, the temperature altering device is operable without invasive action to the patient, thereby reducing hospital workload, administration and costs. Furthermore, the user selected fixing positions within the adjusting mechanism allow the cooling or heating pad to stay in the correct position without the need for constant holding, this reduces patient interference and aids those patients who are weak. Accordingly, the temperature altering device allows pressure and cooling or warming to be applied to the nose simultaneously in a hands free manner whilst maintaining a controlled and constant level of treatment which can be adjusted by the user to suit the patient's needs.

In addition, the temperature altering device can be used as soon as a patient enters the hospital without the need for a specialist. Where the temperature altering device is a cooling device, the cooling device then acts to reduce blood loss by increasing vasoconstriction and reducing swelling, such that the treatment of cautery can still be carried out on the patient even after a length of time has passed. Due to the effects of the cooling device, it is further appreciated that the procedure of cauterising the vessel is much easier to perform because the vessel can be visualised in the nostril.

According to a second aspect of the present invention there is provided a method of treating a nosebleed using the temperature altering device as defined in a first aspect of the present invention, the method comprising the steps of: a) placing the facing surface of the cooling or heating pad against a patient's nose; b) applying closing pressure to the gripping jaws of the temperature altering device in order to engage the cooling or heating pad and urge the cooling or heating pad facing surface against the nose of the patient until the temperature altering device grips the patient's nose;

c) subsequently releasing the temperature altering device

Optionally the method further includes a step of cooling the cooling pad by starting an endothermic reaction within the cooling pad or heating the heating pad by starting an exothermic reaction.

Preferably, the method further includes a step of assembling the temperature altering device. More preferably the method includes a step of assembling the temperature altering device by connecting the cooling or heating pad to the gripping jaws using any suitable fixing means provided wherein preferably the fixing means is present on the engaging surface of the cooling or heating pad. Still more preferably the method further includes a step of assembling the cooling or heating pad by pressing hook and pile fixing means together, wherein the hook and pile portions are located respectively on either the engaging portion of the cooling or heating pad or the gripping jaws.

Alternatively, the method may further include a step of assembling the temperature altering device comprising placing the facing surface of the cooling or heating pad onto the patient's nose then placing the gripping jaws onto the engaging surface of the cooling or heating pad without the need for a fixing means.

Preferably step (b) of the above method comprises applying pressure to the gripping jaws to operate the adjusting mechanism to a degree of jaw closure which substantially corresponds to that of the nose of the patient. Preferably the method further includes a step of leaving the temperature altering device gripped to the patient's nose without contact until the treatment with the temperature altering device is finished. More preferably, the method includes a step of leaving the temperature altering device gripped to the patient's nose without contact for between 5 to 30 minutes or until the bleeding stops.

Alternatively, the method may further include the step of removing the temperature altering device from the patient's nose by operating the release mechanism of the temperature altering device as described herein. Optionally, the temperature altering device of the present invention may be re-usable.

According to a third aspect of the present invention, there is provided a kit of parts which when assembled forms a temperature altering device for the treatment of nosebleeds as described in the first aspect of the present invention, the kit of parts comprising: at least one cooling or heating pad and gripping jaws suitable to engage with the cooling or heating pad and urge the cooling or heating pad against the nose of the patient, wherein the gripping jaws have a plurality of user selected fixing positions corresponding to different degrees of jaw closure around the cooling or heating pad.

Preferably the kit of parts as described in a third aspect of the present invention comprises between 2 and 5 cooling or heating pads. Preferably said cooling or heating pads are of different sizes. More preferably the cooling or heating pads are of different sizes increasing from that suitable for a baby to that suitable for an adult male. Preferably the cooling or heating pads increase in size in regular increments.

The cooling or heating pads of the kit of parts may also vary in shape. Preferably the cooling or heating pads are generally saddle shaped. The saddle shape may be varied by, for instance, softening of the lines defining a saddle shape.

The features of the cooling or heating pad and gripping jaws are as otherwise described herein.

The cooling or heating pad may be secured by a friction fit between the nose and the gripping jaws. Advantageously this also allows the kit of parts to be used with any commercially available cooling or heating pad not just the cooling or heating pads included with the kit of parts.

Advantageously, the kit of parts according to the third aspect of the present invention provides all of the advantages of the temperature altering device of the present invention with further adaptability. Providing different cooling or heating pads allows the user to customise the temperature altering device to meet the needs of the patient and allows one temperature altering device to be reusable with multiple patients, thereby reducing hospital expenditure and allowing a more tailored service to be provided.

All of the features contained herein may be combined with any of the above aspects and in any combination. For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made, by way of example, to the accompanying diagrammatic drawings in which: Figure 1 shows a perspective view of one embodiment of the present invention.

Figure 2a shows a partial cross sectional view of one embodiment of the adjusting mechanism of the present invention. Figure 2b shows a partial cross sectional view of a second embodiment of the adjusting mechanism of the present invention.

Figure 3 shows a cross sectional view of one embodiment of the present invention. Figure 4 shows a plan view of one embodiment of the present invention.

Figure 5a shows an underplan view of one embodiment of the present invention in a first configuration. Figure 5b shows an underplan view of one embodiment of the present invention in a second configuration.

Figure 6 shows a perspective view of an alternate embodiment of the present invention. Figure 7 shows a perspective view of a further alternate embodiment of the present invention.

Figures 8a and 8b are isometric views of a temperature altering device of further embodiment of the present invention in an open and closed state respectively. Figures 8c and 8d are end views of the temperature altering device of Figures 8a and 8b respectively.

Figure 8e is a detail view of a variant temperature altering device of Figures 8a-8d. Figures 9a - 9c are respectively an exploded perspective view, end view and detail view of a temperature altering device according to another embodiment of the present invention.

Figures 10a and 10b are respectively exploded perspective and end views of a temperature altering device according to another embodiment of the present invention. Figures 1 1 a - 1 1 c are respectively an exploded perspective view, end view and variant detail view of a temperature altering device according to another embodiment of the present invention.

Figures 12a and 12b are respectively exploded perspective and end views of a temperature altering device according to another embodiment of the present invention.

Referring to figure 1 , there is shown one embodiment of the present invention in a perspective view. The temperature altering device (100) comprises a first jaw (102) and a second jaw (104) which together form gripping jaws (106) having a so-called saddle shape. The first and second jaws (102 and 104) each comprise a proximal edge (1 10a, 1 10b) and a distal edge (108a, 108b). The distal edges (108) of the first and second jaws (102 and 104) connect together and form a bridge section (1 1 1 ). The gripping jaws (106) in the configuration shown form a substantially U shaped channel designed to accommodate the nose of a patient. The first and second jaws (102 and 104) comprise a distal surface (103) and a proximal surface (105). In use, the proximal surface (105) is in contact with, and attached to, a cooling or heating pad (not shown). The first and second jaws (102 and 104) each comprise a recessed area (1 12) formed substantially in the centre of the distal surface of each jaw and which is appropriately dimensioned to receive a finger and/or thumb of a user. At the bridge section (1 1 1) there is positioned an adjusting mechanism (1 14) which extends longitudinally along the bridge section (1 1 1 ). The adjusting mechanism is not shown in detail here, an example of an adjusting mechanism is shown in close detail in figures 2a and 2b. The adjusting mechanism (1 14) enables the gripping jaws (106) to be adjustable by means of a number of user selected fixing positions ranging from a position where the gripping jaws (106) are at an 180 degree angle relative to each other, down to a position where the gripping jaws (106) are at a 30 degree angle relative to each other. As the user applies even downward pressure to the first and second jaw (102 and 104), the adjusting mechanism (1 14) moves through a number of user selected fixing positions at defined degrees of gripping jaw (106) closure, until the first and second jaws (102 and 104) cause the cooling or heating pad on its proximal side (not shown) to abut against the nose of the patient. Figure 2a shows one embodiment of an adjusting mechanism that may be used in the present invention. The adjusting mechanism consists of a ratchet (216) comprising an engaging member (218), a pawl (220), and a base (222). The engaging member (218) comprises a gear portion (224) which is integral with the distal edge (210) of the first jaw (202). The gear portion (224) comprises teeth (226) each having an arcuate surface terminated by a depression. The teeth (226) are circumferentially spaced around the peripheral surface of the gear (224) at uniform defined intervals, so that the depressions define the available user selected fixing positions that the gripping jaws (206) can be set at. The teeth (226) are each operable to engage and co-operate with the leading edge (228) of pawl (220). The pawl (220) leading edge portion (228) is tapered to facilitate free movement of the pawl leading edge over the arcuate surface of the teeth in one direction of movement and to be urged against the face of the tooth forming the depression in the opposite direction of movement. The elongate pawl has a wider pivot portion (230) at its trailing end wherein the wider pivot portion (230) comprises a first pivot (232). The first pivot (232) rotatably attaches the pawl (220) to the base (222). A spring (233) is also positioned around the first pivot (232) to tension the pawl against the base (222) such that the pawl (220) is constantly drawn towards the base (222) and held by its leading edge against the gear portion (224). The elongate base (222) extends towards the first jaw from the distal edge of the second jaw and is integral with the said second jaw (204) and has journalled therein at the trailing end thereof the first pivot (232) which is also attached to the trailing end of the pawl (220) for pivotable movement of the pawl (220) with respect to the base (222). The elongate base (222) has journalled at its leading end a second pivot (234) which is centrally disposed in and rotatably attaches the gear (224) to the base (222). The second jaw (204) further comprises proximal and distal lugs (236a, 236b) extending from the distal edge of the second jaw (204) and partially around respective sides of the gear portion (224) in a generally peripherally co-extensive and spaced manner in order to protect the patient from the adjusting mechanism (214). The lugs (236) are integral with the second jaw (204) and extend partially around the gear portion (224) so that the leading edges thereof are sufficiently distant to allow the first jaw (202) to be moved with respect to the second jaw between a maximum of 180 degrees and a minimum of 30 degrees. The ratchet (216) may also comprise a release mechanism, which is shown in this embodiment as a lever (238). The lever (238) is fixed to the pawl (220) and extends from the pivot area and away from the ratchet mechanism so that it can be manipulated by the user about the first pivot (232). When the lever (238) is depressed as shown by arrow C, it acts to remove the leading edge of the pawl from the teeth depression (240) of the gear portion (224) so that the gripping jaws (206) can be reset.

In use, to actuate the device, the user applies even proximal pressure to the first and second jaw (202 and 204) as shown by arrows A and B, this causes the base (222) to rotate in a clockwise direction about the second pivot (234) and move towards the engaging member (218). As the base (222) moves, the pawl (220) is in turn pulled via tension in the spring (233) over the teeth (226) of the gear portion (224) through a number of user selected fixing positions until the gripping jaws (206) have urged the cooling or heating pad (not shown) into abutment against the patient's nose. Once the temperature altering device (200) is gripping against the patient's nose, the pawl leading edge (228) sits under spring loading within a depression (240) between the teeth (226) such that it abuts against the teeth (226) and cannot move in the opposite direction, this prevents the gripping jaws (206) from widening and losing their grip upon the nose. Once treatment is finished, or the temperature altering device (200) needs to be reset, the user may depress the lever (238) in the direction shown by arrow C which causes the leading edge (228) of the pawl to be lifted clear of the depression (240) between the teeth (226) thus releasing the gripping jaws. Whilst holding the lever (238) in the depressed position, the user may then pull the first and second jaws (202 and 204) distally away from the nose, such that the base (222) is able to freely rotate in an anticlockwise direction about the second pivot (234). The lever (238) may optionally be depressed until the first and second jaws (202 and 204) have been completely reset to the maximum angle of 180 degrees. The temperature altering device (200) can then be reused.

Figure 2b shows a second embodiment of an adjusting mechanism that may be used in the present invention. The majority of the adjusting mechanism (214') consists of the same ratchet (216) as described for figure 2a and operates by largely the same mechanism. However, in this embodiment, the distal lug (236') bifurcates so that a pawl (220') is formed integrally therewith and instead of the first pivot (not shown) there is provided a deformable joint (242') between the lug (236') and the base (222). A pawl actuating spring (233'), instead of being positioned around the first pivot (not shown) extends between the lug (236') near the trailing end of the pawl part (220') and the base (222) such that the lug (236) and the pawl (220') are tensioned and held against the gear portion (224). In this embodiment, the lever (not shown) is not necessary; instead, the lug (236') and the pawl (220') are able to bend at the joint (242'). In use, the user may pull the lug (236') upwards in the direction of arrow D which will bend the lug (236') at the joint (242') against the spring (233') and remove the pawl leading edge (221) from the depression (240) between the teeth (226). This in turn will allow the base (222) to freely rotate in any direction around the second pivot (234). This in turn allows the first and second jaw (202 and 204) to move apart from each other and loosen their grip upon the patient's nose. The temperature altering device (200) can then be removed from the patient's nose and reset as described for figure 2a.

Figure 3 shows a cross sectional view of one embodiment of the present invention. The temperature altering device (300) comprises a first jaw (302) and a second jaw (304) which form the gripping jaws (306). The gripping jaws (306) are shaped so that a cooling or heating pad (344) located on the proximal surface thereof is capable of close fitting engagement with the outside of the nose. A bridge section (31 1) of the gripping jaws is formed between the distal edges (310a, 310b) of each of the first and second jaws (302 and 304) and houses the adjusting mechanism (314). The jaws (306) are shown in the closed position and generally form a U-shaped channel. The proximal part approaching the edges (308) of each of the first and second jaws (302 and 304) curve outwardly away from each other to match the angle that the nose joins the face. Overall, each of the first and second jaws (302 and 304) is an approximate S shape which, when juxtaposed together, form the approximate U shaped channel of the gripping jaws (306). At the bridge section (31 1) of the gripping jaws (306) is shown the adjusting mechanism (314) which is as described with respect to figure 1 . A cooling or heating pad (344) is co-extensive with the proximal surface of the gripping jaws (306) and in contact therewith via an engaging adaptation (not shown) on the distal surface thereof and further comprises an opposed generally parallel proximal surface (358) which is operable to be placed against the nose of the patient. The cooling or heating pad (344) is approximately sized and shaped such that it at least covers the patient's nose but does not significantly extend beyond the outer peripheral edges of the gripping jaws (306). The cooling or heating pad (344) comprises two co-extensive parallel sheets of material (346 and 348) which are sealed around their mating edge (350) to form an envelope which contains coolant or a heating substance (not visible within the cooling or heating pad).

Figure 4 shows a plan view of one embodiment of the present invention. The plan view shows the temperature altering device (400) opened fully such that the first jaw (402) and the second jaw (404) are at a maximum angle of 180 degrees relative to each other and extend in the same plane. The first and second jaws (402 and 404) together form an overall saddle shape wherein the top portion (452) extends towards the forehead of the patient, and the underplan portion (454) extends towards the mouth of the patient. Each of the first and second jaws (402 and 404) comprises a recessed area (412) symmetrically placed at around the centre of the distal surface of each jaw. The adjusting mechanism (414) is shown between the distal edges (410) of the first jaw (402) and the second jaw (404) at the bridge portion (41 1) of the temperature altering device (400), and the release lever (438) is shown protruding from the adjusting mechanism (414) at the underplan portion (454) of the temperature altering device (400), but may equally be positioned such that it protrudes from the adjusting mechanism (414) at the top portion (452) of the temperature altering device (400), as shown in figure 1 .

Figure 5a shows an underplan view of one embodiment of the present invention in a first configuration. The underplan view shows the temperature altering device (500) with the proximal surface (505) of the first and second jaws (502 and 504) exposed and without the presence of the cooling or heating pad (not shown). The adjusting mechanism (414) and release lever (438) are as shown in figure 4. Each of the first and second jaws (502 and 504) comprises a plurality of fixing means (556) in the forms of islands distributed strategically over the proximal surfaces (505) In this case, the fixing means (556) are shown as hook strips, but they may be formed of any suitable fixing arrangement. The fixing means (556) enable the cooling or heating pad (not shown) to be attached to the first and second jaws (502 and 504) of the temperature altering device (500) at its engaging surface. In this case, the cooling or heating pad (not shown) would comprise mating pile strips at corresponding positions to the hook strips shown here upon its engaging surface. Before using the temperature altering device (500) on a patient, the cooling or heating pad engaging surface (not shown) would be pressed against the proximal surface (505) of the gripping jaws (506) in order to attach the cooling or heating pad to the gripping jaws (506) by the hook strips gripping the pile strips.

Figure 5b shows an underplan view of a further embodiment of the present invention. Most of the features shown in this figure are the same as those shown in figure 5a, except that the cooling or heating pad (544) is attached to the lower surface (505) of the first and second jaws (502 and 504) by fixing means (not visible) on the engaging surface (not visible) of the cooling or heating pad. The proximal surface (558) of the cooling or heating pad (544) is operable to be placed directly against the nose of the patient. The cooling or heating pad comprises a patchwork arrangement of cells (562). The cells are created by melding the two sheets (546 and 548) together in a patchwork manner to create cells (562) within the cooling or heating pad (544) where coolant or heating substance (not visible) is contained.

Figure 6 shows a perspective view of an alternate embodiment of the present invention. The temperature altering device (600) is largely the same as described in the above figures, except for the adjusting mechanism (614) which comprises a section of non-elastically deformable material (664). The non-elastically deformable material (664) extends between the distal edges (610) of the first and second jaws (602 and 604) of the temperature altering device (600) along the entire length thereof such that it forms the bridge section (61 1) of the gripping jaws (606). The non-elastically deformable material (664) is sized such that it approximately spans the bridge of the patient's nose and runs from the bottom end (654) of the temperature altering device (600) up to the top end (652) thereof. The non-elastically deformable material (664) is integral with the first and second jaws (602 and 604). In use, the user may apply closing pressure to the first and second jaws (602 and 604) so that the non-elastically deformable material is flexed and deforms causing the gripping jaws (606) to close. Once the gripping jaws (606) are in the desired user selected fixing position so that the cooling or heating pad facing surface (not shown) is abutting against the nose, the user may release contact with the temperature altering device (600) which then grips the patient's nose in a hands-free manner. The non-elastically deformable material (664) remains at the position at which pressure is released by the user due to the non-elastic nature of the material. Such an embodiment has the advantage that the number of user retracted fixing positions is not restricted as with a ratchet mechanism, the non elastically deformable material (664) can hold any position on a continuous scale from a maximum of 180 degrees between the gripping jaws, down to where the gripping jaws (606) are completely closed. To release the temperature altering device (600), the first and second jaws (602 and 604) need only be pulled apart by the user applying pressure to the first and second jaws (602 and 604) in an outward direction. Figure 7 shows a further perspective view of an alternate embodiment of the present invention. The temperature altering device (700) is largely the same as described in the above figures, except for the adjusting mechanism (714) which comprises a concertinaed hinge (766). The concertinaed hinge (766) extends between the distal edges (710) of the first and second jaws (702 and 704) of the temperature altering device (700) along the entire length thereof such that it forms the bridge section (71 1) of the gripping jaws (706). The concertinaed hinge (766) is sized such that, in use, it approximately spans the bridge of the patient's nose and runs from the bottom portion (754) of the temperature altering device (700) up to the top portion (752) thereof. The concertinaed hinge (766) is integral with the first and second jaws (702 and 704). The concertinaed hinge (766) comprises a plurality of folds in the material of the hinge which form articulations (768). The articulations (768) are spaced at regular intervals across the hinge (766) which intervals define the available user selected fixing positions that the gripping jaws (706) can be set at. In use, the user may apply closing pressure to the first and second jaws (702 and 704), so that the articulations (768) of the hinge (766) deform and spread as the folded material opens outwards in order to allow the gripping jaws (706) to move towards each other. Once the gripping jaws (706) are in the desired user selected fixing position in that the cooling or heating pad (not shown) is abutting against the nose, the user may release contact with the temperature altering device (700) which then grips the patient's nose in a hands-free manner. The concertinaed hinge (766) remains at the position at which pressure is released by the user due to the nature of the deformed articulations (768). To release the temperature altering device (700) the first and second jaws (702 and 704) need only be pulled apart by the user applying pressure to the first and second jaws (702 and 704) in an outward direction, which causes the articulations (768) to deform once again and collapse. Figures 8a to 8d show isometric and end views of a further embodiment of the present invention. Similar parts to the previous embodiments are labelled by the same numeral but with the prefix "8".

As in the previous embodiments, the temperature altering device (800) has a saddle shape or inverted U-shape defined by first and second jaws (802, 804) which together form gripping jaws (806) separated by a bridge section (81 1 ).

The device (800) comprises two separate portions that each pass over the patient's nose, an inner portion (872) and an outer portion (874), where the portions are moveable vertically with respect to each other. The outer portion (874) is dimensioned to progressively bear on the inner portion as they are brought towards the position of Figures 8b and 8d in use. The inner portion (872) is arranged to close by pivoting as the outer portion (874) bears against it. An adjusting mechanism (814) in the form of a ratchet mechanism (816) is arranged between the two portions to selectively maintain the first and second jaws (802, 804) at a desired position as described in more detail below.

The outer portion (874) has a raised region (875) at the bridge (81 1 ) in addition to its first and second jaws (802a and 804a). The outer portion (874) has three recessed regions (882, 883, 884) which are appropriately dimensioned to receive a finger and/or thumb of the user, one (883, 884) at each lower end of the first and second jaws (802a, 804a) to allow the user to hold the temperature altering device in place and one (882) at the top of the raised region (875) to vertically adjust the two portions with respect to each other.

In this embodiment the outer portion (874) of the temperature altering device (800) is a moulded component produced from a relatively rigid, but resilient plastics material. As can be seen in Figures 8c and 8d, hollows are provided in the rear thereof to save materials, whilst maintaining the desired level of rigidity, and enabling the outer portion (874) to be produced using simple two part tools, keeping tool costs to a minimum.

The inner portion (872) comprises a more flexible plastics member with a cooling or heating pad (844) of the type described in the preceding embodiments fixed or bonded to the proximal surface (805) thereof. In this embodiment the cooling or heating pad (844) further comprises two protruding sections (876) on its proximal side designed to abut against the nose of the patient in use, but in other embodiments these may not be present.

The cooling or heating pad (844) further comprises a protruding region (873) extending rearwardly from the bridge section to extend up the nose of the patient towards the forehead nasion region. The protruding region (873) is designed to be provide a close fit of the cooling or heating pad to the patient's nose and to provide cooling to a larger area of the nose.

The inner portion (872) further comprises outwardly protruding guide ribs (880 and 881) on its front and rear respectively. These ribs (880, 881) guide the outer portion (874) during the relative vertical motion and inhibit it from sliding off the inner portion (872).

The inner (872) and outer (874) portions are connected via the adjusting mechanism (814). In this embodiment this is a ratchet mechanism (816) located at the bridge section (81 1) The ratchet mechanism (816) comprises a pair of integral upwardly extending resilient pawls (820) having opposed outward facing pawl teeth (827) at the top thereof extending from the bridge (81 1) of the inner portion (872). On the outer member (874) the ratchet mechanism comprises a void (888) extending upwardly into the raised region (875) and having complementary engaging means in the form of a linear array of teeth (826) having a complementary "sawtooth" profile to the pawl teeth (827).

The pawls (820) are spaced such that they are able to resiliently flex and allow the pawl teeth (827) to ride over the teeth (826) when the outer portion (874) is depressed to be closer to the inner portion (872). However the pawl teeth (827) and teeth (826) have complementary engagement surfaces (829 and 818) which restrain the reverse movement.

Thus, a number (in this embodiment, five) user selected fixing positions are provided of the outer portion (874) with respect to the inner portion (872).

In use, the device (800) is supplied in the position shown in Figures 8a and 8c (i.e. an open position) where the outer portion (874) is not applying any pressure or a relatively low pressure to the gripping jaws (806). The patient or a healthcare professional then positions the device (800) over the patient's nose, gripping it by the recessed regions (883) and (884) with thumb and middle finger. Using their index finger in recessed region (882), they depress the outer portion (874), such that it slides with respect to the inner portion (872) and applies a progressively increasing pressure to the gripping jaws (806), causing the jaws to pivot together resulting in a reduction in the spacing between the gripping jaws.

Figure 8d shows a rear view of the temperature altering device (800) in its fully closed position in which - absent a reaction force - the angle of the jaws is reduced. In this configuration the gripping jaws (806) are fully closed around the patient's nose, although this is not depicted in the figure.

As sliding occurs the pawl teeth (827) engage behind progressively higher teeth (826) of the outer portion (874) and block the natural tendency of the outer portion to return to the Figure 8c position when the load is removed. Accordingly the device (800) may be adjusted until the correct amount of clamping pressure is achieved to hold it on the patient's nose and staunch a nosebleed.

Figure 8e illustrates an alternative ratchet mechanism (816') for a device (800') which is otherwise similar to the device (800). The ratchet mechanism (816') has a rounded pawl tooth (827') with a vertical slot (829') such that it may be compressed in the direction of the arrows E. The void (888') comprises an interconnected series of spherical regions arranged to define teeth (826') therebetween, which require the pawl tooth (827') to compress each time it passes from one region to the next. Thus a similar series of user selected fixing position are provided, but a separation of the inner and outer members (872, 874) may be achieved more easily than in the previous embodiment. This variant may have more utility if the device is intended to be multi-use, not single use.

Figures 9a to 9c shows a temperature altering device (900) of a further embodiment of the present invention where like parts are labelled by like numerals, but with the prefix "9". In this embodiment the bridge section (91 1) of the outer portion (974) comprises a guide pin (990) located centrally and extending forward from the bridge section. The bridge section (91 1) of the inner portion (972) comprises a vertical elongate slot (991 ), which when the temperature altering device (900) is assembled receives the pin (990) as can be seen in Figures 9b and 9c. This slider system limits the vertical movement of the outer portion (974) of the temperature altering device (900) relative to the inner portion (972).

In this embodiment the inner (972) and outer (974) portions are connected by a ratchet mechanism located at the lower ends of the gripping jaws (906) where each of the lower ends of the inner portion comprise a plurality of teeth (926) on the outer surface thereof. The outer portion (974) has pawl teeth (927) facing inwards at the lower ends of jaws 902a and 904a. When the outer portion (974) of the temperature altering device (900) is depressed onto the inner portion (972) to adjust the fit of the temperature altering device around the patient's nose the pawl teeth (927) of the outer portion will engage with the teeth (926) to block the natural tendency of the outer portion to slide back up when the load is removed. The plurality of teeth (926) correspond to different degrees of jaw closure around the patient's nose.

Figures 10a and 10b use a similar arrangement to Figures 9a-c, Similar parts to the previous embodiments are labelled by the same numeral but with the prefix "10". In this embodiment, the pin and slot is omitted and. Instead, a ridge (1093) on the inner face of the jaws of the outer portion (1074) engages with a corresponding slot (1094) present on the outer surface of the inner portion (1072) of the temperature altering device (1000) to retain alignment of the two portions front-to-rear. In Figures 1 1 a and 1 1 b a similar ratchet mechanism to Figures 9a-c is used but the mechanism is contained in a void (1 188) formed at each the lower ends of the inner gripping jaws (1006). The void is defined by an additional outer cover (1 190) of the inner portion. The outer cover includes the recessed regions (1 183 and 1 184). A slot (1 192) is provided in the cover to receive and guide the outer member (1 174).

Figure 1 1 c shows a variant of the Figure 1 1 a and b embodiment in which further teeth (1 194') acting fore-aft are provided to inhibit removal of the outer portion (1 174') from the slot (1 192). The further embodiment of Figures 12a and 12b shows a temperature altering device (1200) similar to that of Figures 1 1 a and 1 1 b, except that pawl teeth in the form of pins (1227) extend forward from the outer portion (1274) to be selectively engaged in teeth along a front edge of the voids (1288).

It will be appreciated that terms such as upper and lower, inner and outer are used for ease of explanation and should not be regarded as limiting.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. Further it will be appreciated that the position of various components may be reversed between the inner and outer portions - for example the pawl may be positioned on the outer member and the complementary teeth on the inner member. High friction areas may replace the finger recesses.

Claims

1 . A temperature altering device for the treatment of nose bleeds comprising a cooling or heating pad having a facing surface for placement against, and effective to cool or warm, the nose of a patient, and gripping jaws extending around and engaging with the cooling or heating pad which are operable to urge the cooling or heating pad facing surface against the nose of a patient, wherein the gripping jaws have a plurality of user selected fixing positions corresponding to different degrees of jaw closure around the cooling or heating pad and therefore against the nose of the patient in use.

2. A temperature altering device according to Claim 1 wherein the temperature altering device is appropriately dimensioned for use on any elongate member of the human or animal body in need of cooling treatment, for example to reduce post operative swelling in members such as the fingers or toes.

3. A temperature altering device according to claim 1 or claim 2 wherein the gripping jaws comprise a first and a second jaw.

4. A temperature altering device according to any preceding claim wherein the gripping jaws form a substantial V or U shape in cross section.

5. A temperature altering device according to any preceding claim wherein the gripping jaws form a substantial U shape in cross section which is ergonomically suited to the shape of the nose such as, for example, by having a curved inner face for close fitting conformity with the bridge of a patient's nose at the bridge section.

6. A temperature altering device according to any preceding claim wherein the temperature altering device comprises an inner and an outer portion.

7. A temperature altering device according to claim 6 wherein the inner and outer portions have complementary shapes.

8. A temperature altering device according to claim 7 wherein the inner and outer portions have complimentary U shapes.

9. A temperature altering device according to any one of claims 3 to 8 wherein the first and second jaws are substantially symmetrical with respect to each other.

10. A temperature altering device according to any one of claims 3 to 9 wherein the first and second jaws are connected via a bridge section.

1 1 . A temperature altering device according to claim 10 wherein, in use, the bridge section sits substantially over the bridge of the patient's nose, in use.

12. A temperature altering device according to any preceding claim wherein the angle of the gripping jaws is adjustable between the user selected fixing positions.

13. A temperature altering device according to claim 12 wherein relative movement of the outer portion with respect to the inner portion adjusts the degree of closure of the gripping jaws.

14. A temperature altering device according to any preceding claim wherein the adjusting mechanism is located in, or in the region of, the bridge section of the gripping jaws.

15. A temperature altering device according to any preceding claim wherein the adjusting mechanism is located in the region of the lower ends of the gripping jaws.

16. A temperature altering device according to any one of claims 6 to 15 wherein the inner and outer portions are arranged to be biased for movement away from each other and the adjusting mechanism resists this movement.

17. A temperature altering device according to any preceding claim wherein the outer portion is depressed onto the inner portion to adjust the angle of the gripping jaws.

18. A temperature altering device according to any preceding claim wherein the adjusting mechanism is a ratchet mechanism.

19. A temperature altering device according to claim 18 when dependent upon claim 6 wherein the inner and outer portions are connected via the ratchet mechanism.

20. A temperature altering device according to claim 19 wherein the ratchet mechanism comprises a pawl mounted on the inner portion and an engaging means mounted on an outer portion.

21 . A temperature altering device according to claim 19 wherein the ratchet mechanism comprises a pawl mounted on the outer portion and an engaging means mounted on the inner portion.

22. A temperature altering device according to any one of claims 18 to 21 wherein the ratchet mechanism permits relative movement in one direction only.

23. A temperature altering device according to any one of claims 6 to 22 wherein a guide arrangement is provided between the inner and outer portions.

24. A temperature altering device according to claim 23 wherein the guide arrangement comprises a male sliding portion on one the inner and outer portions and a female sliding portion on the other of the inner and outer portions.

25. A temperature altering device according to any one of claims 3 to 24 wherein the first and second jaws each comprise a recessed or high friction area on the outer surface thereof which is appropriately dimensioned to receive a finger and/or thumb of a user,

26. A temperature altering device according to any one of claims 10 to 25 further comprising a third recessed or high friction area on the bridge to provide an aid for finger placement when positioning the device upon the nose of a patient.

27. A temperature altering device according to claim 25 wherein the first and second recessed or high friction areas are on the outer portion of the temperature altering device.

28. A temperature altering device according to claim 25 wherein the first and second recessed or high friction areas are on the inner portion of the temperature altering device.

29. A temperature altering device according to any preceding claim wherein the temperature altering device forms a shape which is ergonomically suited to conform to a human or animal nose.

30. A temperature altering device according to any preceding claim wherein the cooling or heating pad comprises an elongate section that extends up the nose, generally from the tip, towards the forehead nasion region.

31 . A temperature altering device according to claim 30 wherein the elongate section that extends up the nose, extends from the bridge section of the cooling or heating pad.

32. A temperature altering device according to any preceding claim wherein the cooling or heating pad forms a substantial U shape that passes over the patient's nose.

33. A temperature altering device according to any preceding claim wherein the cooling or heating pad is of a shape that provides maximum coverage to the surface of the nose.

34. A temperature altering device according to any preceding claim wherein the cooling or heating pad is of a shape that economically matches the shape of the nose.

35. A temperature altering device according to any preceding claim wherein the cooling or heating pad is connected to the gripping jaws by a fixing means.

36. A temperature altering device according to any preceding claim formed from any suitable polymeric material.

37. A temperature altering device according to claim 36 wherein the gripping jaws are formed from a polymeric material that is rigid at ambient temperature.

38. A temperature altering device according to claim 37 wherein the gripping jaws are formed from a solid medical grade polymeric material such that the gripping jaws are both inflexible and hygienic.

39. A temperature altering device according to claim 36 wherein the gripping jaws are formed from a polymeric material that is resilient at ambient temperature.

40. A temperature altering device according to any preceding claim wherein the cooling or heating pad comprises an envelope which is filled with a coolant or a heating substance.

41 . A temperature altering device according to claim 40 wherein the envelope is a sealed container comprising the coolant or heating substance.

42. A temperature altering device according to claim 41 wherein the envelope is composed of a material which does not cause ice burn, for example a material with a low surface friction.

43. A temperature altering device according to any one of claims 40 to 42 wherein when the coolant or heating substance is a coolant, the coolant comprises material capable of selectively causing an endothermic reaction or when the coolant or heating substance is a heating substance the heating substance comprises material capable of selectively causing an exothermic reaction.

44. A method of treating a nosebleed using the temperature altering device as defined in any preceding claim, the method comprising the steps of:

d) placing the facing surface of the cooling or heating pad against a patient's nose; e) applying closing pressure to the gripping jaws of the temperature altering device in order to engage the cooling or heating pad and urge the cooling or heating pad facing surface against the nose of the patient until the temperature altering device grips the patient's nose;

f) subsequently releasing the temperature altering device.

45. The method of claim 44 further including a step where the cooling or heating pad is a cooling pad of cooling the cooling pad by starting an endothermic reaction within the cooling pad or where the cooling or heating pad is a heating pad of starting and exothermic reaction within the heating pad.

46. The method of claims 44 or 45 further including a step of assembling the temperature altering device.

47. The method of claim 44 wherein the method includes a step of assembling the temperature altering device comprising placing the facing surface of the cooling or heating pad onto the patient's nose then placing the gripping jaws onto the engaging surface of the cooling or heating pad without the need for a fixing means.

48. The method of any one of claims 44 to 47 wherein step (b) comprises applying pressure to the gripping jaws to operate the adjusting mechanism to a degree of jaw closure which substantially corresponds to that of the nose of the patient.

49. The method according to any one of claims 44 to 48 further includes a step of leaving the temperature altering device gripped to the patient's nose without contact until the treatment with the temperature altering device is finished.

50. A kit of parts which when assembled forms a temperature altering device for the treatment of nosebleeds as claimed in claim 1 , the kit of parts comprising: at least one cooling or heating pad and gripping jaws suitable to engage with the cooling or heating pad and urge the cooling or heating pad against the nose of the patient, wherein the gripping jaws have a plurality of user selected fixing positions corresponding to different degrees of jaw closure around the cooling or heating pad.

51 . A kit of parts as claimed in claim 50 comprising between 2 and 5 cooling or heating pads.

52. A kit of parts according to claim 51 wherein said cooling or heating pads are of different sizes.

53. A kit of parts according to claim 52 wherein the cooling or heating pads are of different sizes increasing from that suitable for a baby to that suitable for an adult male.

54. A cooling device for the treatment of nose bleeds comprising a cooling pad having a facing surface for placement against, and effective to cool, the nose of a patient, and gripping jaws extending around and engaging with the cooling pad which are operable to urge the cooling pad facing surface against the nose of a patient, wherein the gripping jaws have a plurality of user selected fixing positions corresponding to different degrees of jaw closure around the cooling pad and therefore against the nose of the patient in use.