Container

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CONTAINER

The present invention relates to a container.

The increasing incidence of organ transplants, and the increasing use of temperature-sensitive drugs in the treat- 5 ment of disease in both humans and animals, has led to a need for a reliable portable container for such organs and drugs. It is currently usual for organs and drugs to be transported in boxes packed in ice. This is unsatisfactory for a number of reasons. 10

Firstly, the use of ice means that the highest temperature which the organs or drugs can be kept at is freezing point, or 0° C. Ice crystals will start forming at this temperature, and the growth of these ice crystals can damage the cells of an organ being transported for transplant, unless steps are 15 taken to avoid this. In addition, 0° C. may not be the optimum temperature at which drugs should be kept.

Secondly, the ice will melt in time, and so the temperature at which the drugs or organs will be held is not steady. It may be necessary to replenish the ice during transporta- 20 tion.

To avoid these problems, it is desirable to provide a container with some means of regulating its temperature, for example with a Peltier effect device which can heat or cool the contents and a control unit. 25

A further use of medical containers is in the transport of samples of infectious or contaminated material. For example, samples of such material may need to be taken to a laboratory for analysis. It is frequently necessary to maintain such samples at given temperatures, to ensure that 30 bacteria in the samples are still alive when they reach the laboratory and can then be cultured and identified. However, it will be appreciated that transport of such samples poses a number of problems. In particular, following such transportation, it is necessary to ensure that the container is 35 properly sterilized afterwards, to prevent crosscontamination. This can be done by washing or autoclaving, but it will be understood that these methods may not be ideally suited to cleaning a Peltier device.

According to a first aspect of the invention, there is 40 provided a portable container for receiving contents for transport whilst regulating the temperature of the contents, the portable container comprising heating and/or cooling means in the form of a Peltier effect device, a removable inner receptacle for receiving the contents, an air gap around 45 the outside of the inner receptacle, and a control unit for controlling the Peltier effect device so as to regulate the temperature of the air around the outside of the inner receptacle and thereby regulate the temperature of the contents of the inner receptacle. 50

The heating and/or cooling means may comprise a heating means only, or a cooling means only. However, it is preferred that both heating and cooling means are provided.

The control of the temperature of the air in the air gap around the inner receptacle enables regulation of the tern- 55 perature of the contents whilst still permitting the inner receptacle to be removed. Removal of the inner receptacle is useful, for example enabling it to be washed or autoclaved. In addition, when removed the inner receptacle may be placed in a refrigerator. It may thus be refrigerated to the 60 desired temperature, before being placed into the main container, which can then be closed and activated to regulate the temperature of the contents of the inner receptacle. This reduces the amount of power used by the portable container, as it is only necessary to keep the contents cold, rather than 65 having to cool them down initially. If for example the container is powered by a battery, then the length of time for

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which the container can keep its contents cold, and thus the length of journey which can be undertaken, can be increased.

The portable container can be used to carry drugs, tissue samples, organs for transplant, or indeed any other material which must be transported at a given temperature.

The container will generally have an outer housing, with the air gap being defined between the outer housing and the inner receptacle. The outer housing may comprise a base portion and a lid portion.

A fan is preferably provided to assist air circulation in the air gap. This is advantageously provided adjacent to the Peltier device, both for example being located in a lid portion of the container.

Preferably, the container comprises projections which extend from the outer housing of the container to support the inner container. Air can then circulate between the projections around the inner receptacle. In addition, the projections help to locate the inner container securely in the main container.

Preferably, the control unit of the container is arranged to store a desired temperature for the contents of the container, to receive a signal from a temperature sensor located within the container, and to generate a signal to control the Peltier effect device. From a comparison of the sensed temperature signal with the desired temperature, the control unit decides whether to operate the Peltier effect device, and in what sense (heating or cooling the interior of the container). The temperature sensor is preferably arranged to sense the temperature in the air gap. More than one sensor may be provided, e.g. one above the inner receptacle and one below.

The temperature at which the contents of the container are to be maintained can be set permanently in the control unit. However, as the container may be used with different materials, it is preferred that the temperature at which the contents of the container are to be maintained is entered into the control unit.

This information can be entered in any suitable manner. In a preferred version, a keypad is mounted on the container for entering the desired temperature. However, the keypad may be susceptible to damage, and so alternatively or additionally, the container may comprise an electromagnetic or ultrasonic receiver , and the temperature is set using an external transmitter. In a further version, the container may be connectible to a computer, either directly or via a modem, and this is used to set the temperature.

It may be important that the desired temperature, once set, is not changed without authorization, and thus it is preferred that the control unit includes means for verifying the status of a user before the temperature at which the contents of the container are to be maintained is set. If a key-pad is used, then it may be necessary to enter a code (such as a PIN) before the set temperature can be changed. Codes can also be used if a radio or a computer system is used to enter the information. A card system, for example using swipe cards, or a system where a key has to be inserted into a lock before the set temperature can be modified, could also be used.

It is also generally desirable to know the temperature history of the contents of the container.

In previous containers, there is no guarantee that the organs or drugs have not been damaged during transit by exposure to inappropriate temperatures, as there is no record of the temperatures to which they have been exposed. Thus, it is preferred that the control unit also comprises a temperature logging system, said temperature logging system providing means to verify the temperature history of the container.

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This feature is considered to be of independent inventive merit, and so according to a further aspect of the invention, there is provided a portable container for receiving contents for transport whilst regulating the temperature of the contents, the portable container comprising heating and/or cooling means, and a control unit for controlling the heating and/or cooling means so as to regulate the temperature of the contents of the container, said control unit comprising a temperature logging system, said temperature logging system providing means to verify the temperature history of the contents of the container.

The temperature logging system can take a number of forms. For example, a device similar to a tachograph can be used, to sample the temperature at given intervals and make a mark on a record sheet. The marks could (as in a tachograph) require interpretation in order to be understood. However, in a preferred version, the temperature logging system samples the temperature at intervals, and prints the sampled temperature. It is then only necessary to check the printout to see whether the set temperature has been adhered to. Alternatively, the temperature logging system can be provided with a memory which stores data concerning the temperature history. The information in this memory can be accessed by suitable means such as a computer using a modem, optionally by a remote link, and displayed. As an alternative, the computer can be programmed to check the data itself, and give a simple "safe/unsafe" output. Whatever method is chosen, the temperature history of the contents can be checked when the container arrives at its destination, and the recipient can thus immediately verify whether the contents have been damaged by exposure to inappropriate temperatures during transit. The contents of the container are thus immediately verifiable.

Of course, while it is useful to know that the material being transported has spoiled as a result of being exposed to inappropriate temperatures, it would be better for the material not to spoil at all, to avoid wastage. This is particularly important in the case of organs for transplant. Thus, in a preferred embodiment, the control unit generates an alarm signal if the temperature in the container strays too far from the set temperature. The meaning of "too far" will of course depend on the material being transported, but 3° C. is a typical amount. This alarm signal may take the form of a light on the container or an audible signal, which would alert a person travelling with the container that something is amiss.

Alarm signals can also be generated if the latches holding the container closed are detected as being opened, as this can indicate that the container, and possibly the contents thereof, have been tampered with.

The container can be powered in any suitable manner. However, as the container is intended to be portable, the power for the Peltier device, the control units and the fan motors is preferably derived from a battery, more preferably a rechargeable battery. It is preferred that a back-up power source is also provided, in the form of a second battery, so that even if the main battery is exhausted the container can still regulate the temperature of its contents. An alarm signal can be generated on failure of the main battery, and a further different alarm signal can be generated when the back-up battery falls below a predetermined proportion of its capacity.

Further, it is preferred that the container be sufficiently robust to withstand impacts and shock loading. It is inevitable that accidents will occur, and that containers will be dropped from heights, hit and so on. However, Peltier devices are relatively fragile, and must be protected from severe impacts.

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Thus, it is preferred that the Peltier device is mounted in a block of elastomeric material. The provision of this elastomeric element helps to reduce the decelerations undergone by the Peltier device, and thus reduces the shock loads 5 thereon.

This feature is considered to be of independent inventive merit, and so according to a further aspect of the present invention, there is provided a portable container having heating and/or cooling means in the form of a Peltier effect device, wherein the Peltier device is mounted in a block of elastomeric material which is in turn mounted to a housing of the container.

It is further preferred that the Peltier device is connected to an inner heat sink facing the interior of the container and an outer heat sink facing the exterior of the container, the

15 heat sinks being clamped together by clamping means passing through the heat sinks and the elastomeric member. The Peltier device, the heat sinks and the elastomeric member then form a single unit, and the heat sinks and the Peltier device will undergo the same decelerations. It is

20 desirable that the heat sinks remain in intimate thermal contact with the Peltier device, to enable it to function properly, and this feature reduces the risk that they may be jolted apart.

The clamping means can take any suitable form.

25 However, if there is a path of conduction from the inner heat sink to the outer heat sink, then the insulative properties of the container will be compromised, as indeed will the efficiency of the Peltier device. Thus, it is preferred that the clamping means is formed from a plastics material. In a

30 particularly preferred embodiment, the clamping means are nylon bolts.

Of course, if the container is to keep the contents at a given temperature, it is desirable that it have a thermally insulating outer housing, to prevent variations in the external

35 temperature from affecting the temperature of the contents. A number of ways of constructing thermally insulating containers are known. For example, a Dewar flask has a double-walled construction. The space between the walls is evacuated to provide a vacuum, and the sides of the walls

40 facing the vacuum are silvered. It is also known to use thermally insulating material such as foamed polymer materials such as polyurethane in the walls of containers, to reduce heat conduction across the wall.

It is known to use vacuum panels for thermal insulation.

45 These panels comprise a layer of thermally insulating material enclosed within an evacuated flexible cover, which includes an aluminium layer. When such panels are used to insulate containers, they are normally placed in the hollow walls of the container to reduce the heat passing through the

50 walls by conduction. However, the presence of air in the hollow walls still allows heat transfer through convection.

Preferably, the container comprises an outer housing in the form of an inner wall and an outer wall defining a space therebetween, wherein the space between is the inner and

55 outer walls is at least partially evacuated and is occupied by a solid thermally insulating material.

The inner and outer walls thus define the space which is at least partially evacuated and occupied by the insulating material, in addition to their other function as container

60 walls.

The presence of the thermally insulating material reduces the amount of heat which is transferred through the container walls by means of conduction. Further, heat transfer by means of convection is reduced by the at least partial 65 evacuation of the space between the inner and outer walls. Of course, the greater the degree of evacuation, the less heat is transferred by convection.

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This feature is also considered to be of independent inventive merit, and so according to a further aspect of the present invention there is provided a container comprising an inner wall and an outer wall defining a space therebetween, wherein the space between the inner and outer 5 walls is at least partially evacuated and is occupied by a solid thermally insulating material.

Such a container can removably hold contents which are to be thermally insulated from the environment, and will therefore generally have a main body and a closure. 10

The insulating material can be in the form of a powder. However, it is then necessary for the inner and outer walls to be relatively rigid and strong. Accordingly, it is preferred that the insulating material is rigid. The insulating material will then contribute to the structural integrity of the con- 15 tainer as a whole. One suitable insulating material is compacted microporous silica.

If a rigid insulating material is used, it will normally be shaped to occupy the space between the inner and outer walls, for example by being moulded or machined to the 20 required shape.

In a preferred embodiment, the insulating material hinders the passage of infra-red radiation. This can be done by absorbing, reflecting or scattering the infrared radiation, and reduces the amount of heat transferred through the walls of 25 the container by means of radiation.

In a further preferred embodiment, the outer wall is metallized. The metallized layer will attenuate any radiation passing through it, and this also helps to reduce the amount of heat transferred through the walls of the container by 30 means of radiation. Using a metallized outer wall with an insulating material that absorbs infra-red radiation can reduce the amount of heat transferred to very low levels.

Preferably, it is the inner surface of the outer wall that is metallized. This protects the metallized layer from abrasion 35 and so on, which it would be subjected to if it was on the outer surface of the outer wall, and thus prolongs its lifespan.

As an alternative to, or additionally to providing a metallized layer, the outer wall may include a metallic foil layer. The outer wall can be formed as a laminate, incorpo- 40 rating a metallic foil layer.

It is further preferred that the inner wall of the container is metallized. When it is desired to maintain the contents of the container at above ambient temperature, it is important to reduce heat losses from the contents, and metallizing the 45 inner wall reduces the amount of infra-red radiation passing through the inner wall.

Alternatively or additionally, the inner wall may include a metallic foil layer, and may be formed as a laminate incorporating a metallic foil layer. 50

The metallization or the metallic foil layer of the inner or outer walls can be provided with means for making an electrical connection to provide an electrostatic shield. This can then serve to shield any electrical equipment inside the container from electrical interference. It is envisaged that the 55 insulated container will include an electrical cooling and/or heating means, and the switching of this means could cause interference if it were not shielded.

The space between the inner and outer walls can be at least partially evacuated and then permanently sealed. 60 However, as any material used to form the inner and outer walls will be permeable to some degree, it is preferred that some means of restoring the vacuum be provided. Accordingly, in a further preferred embodiment, there is provided a passageway to allow the space between the inner 65 and outer walls to be communicated with a region outside of the space. The passageway can allow the space between the

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inner and outer walls to be connected to a pressure gauge, a vacuum pump or the like. The vacuum in the space between the inner and outer walls can then be checked by means of a pressure gauge, and if the vacuum has become overly degraded, as a result of excessive gas permeation through the inner and outer walls, then it can be restored using the vacuum pump.

Of course, means must be provided to ensure that there is no leakage at the passageway. This could be done by providing a plug in the passageway. However, it is preferred that the passageway be provided with a valve, which is normally closed. The valve can then be opened when a pressure gauge, vacuum pump or the like has been connected.

The passageway can be provided at any convenient point on the inner or outer walls, or on e.g. an end wall which connects the inner and outer walls. However, if the passageway is in the outer wall, then there is a risk that an impact or similar could open it, for example by damaging a valve provided on the outer wall. It would be possible to recess a valve in the outer wall to reduce the risk of impact damage. However, it is preferred that the inner wall be provided with the passageway, to substantially eliminate the risk of impact damage to it.

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

FIG. 1 is a perspective view of a first embodiment of the container in a closed condition;

FIG. 2 is a fragmentary schematic cross-sectional view showing the construction of a wall of the first embodiment of the container;

FIG. 3 is a fragmentary schematic cross-sectional view showing a variant construction of a wall of the first embodiment of the container;

FIG. 4 is a cross-sectional view through a second embodiment of the container;

FIG. 5 is a fragmentary cross-sectional view of the lid of a third embodiment of the container;

FIG. 6 is a plan view of a part of the lid of the third embodiment of the container; and

FIG. 7 is a perspective view of the same part of the lid of the third embodiment of the container.

A container according to a first preferred aspect of the invention is indicated by the reference numeral 10 in FIG. 1. The container comprises a base part 12, in which the contents are accommodated, and a lid 14. The base part and the lid together form an outer housing. The lid 14 is attached to the base 12 by a hinge, clamps or the like, and the container is held closed by latches 76. The container is intended to thermally isolate its contents from the outside, for example to keep the contents cooler than outside.

The walls of the container have a sandwich construction, as is best shown in FIG. 2. They comprise an outer wall 20, which forms the external surface of the container, a middle layer 30, and an inner wall 40. The middle layer occupies the space between the inner and outer walls.

The outer wall fulfils a number of functions. It is substantially gas- and liquid-impermeable. It is also important for the material forming the outer wall to be strong, and in particular to be puncture-resistant. In order for the outer wall to meet these various criteria, a resin-bonded laminated material is used. The laminate can include layers of Kevlar (trade mark) or glass- or carbon-fibre reinforced plastics material, to provide the necessary strength. Such materials are very strong in tension, compression and shear, and also display good resistance to shock loads. This is important in helping avoid damage to the container when it is dropped. 8

The inner surface 22 of the outer wall 20 is metallized. This can be done by spraying, sputtering or vacuum deposition of steel or aluminium. The metallized layer reflects most of the radiation incident thereon, and attenuates the radiation passing through the outer wall 20. If the metallized 5 layer were to be applied to the outer surface 24 of the outer wall 20 rather than the inner surface 22, then it would be subject to scratching, abrasion and the like. Any discontinuities in the metallized layer will allow radiation to pass through it unaffected, and this is clearly undesirable. For this reason, the metallized layer is applied to the inner surface 22 of the outer wall 20.

Alternatively, or additionally, the laminated material can include one or more metallic foil layers. These will not only serve to reflect and attenuate radiation, but also reduce the overall permeability to gases of the outer layer. 15

One or more of the metallized or metallic foil layers can be provided with means for making an electrical connection to provide an electrostatic shield. This shield will function as a Faraday cage, and will screen any interference which may otherwise be caused by electrical equipment such as heaters, 20 coolers or thermostatic controls inside the container.

The middle layer 30 comprises a porous expanded silica material, which occupies substantially the whole of the lateral width between the inner and outer walls (i.e. the direction transverse to the planes of the walls). The material 25 has a very low thermal conductivity, and serves as a thermal insulator for the container. Such a material is available under the name "Microfherm" from Micropore International Limited of Droitwich, England. In addition to its thermally insulating characteristics, the material is rigid and contrib- 30 utes to the strength and structural integrity of the container.

The expanded silica material can also be treated to further reduce the transmission of infra-red radiation through it. It can incorporate metallic platelets to reflect infra-red radiation, semiconductors such as carbon black or 35 metal oxides to absorb infra-red radiation, and/or high refractive index transmitters to scatter infra-red radiation. These serve to make the middle layer substantially opaque to infra-red radiation. As a result, any infra-red radiation which does pass through the outer wall 20 will not reach the 40 interior of the container 10. Further, the size of the pores in the expanded silica material is less than the mean free path of air molecules.

The inner wall 40 can be constructed in a similar way to the outer wall 20, since it must also be substantially imper- 45 vious to gases or liquids. However, as the inner wall 40 is less likely to be subjected to direct impacts or similar shocks, it does not require the same strength as the outer wall 20. Further, since any infra-red radiation passing into the container should be prevented from passing through the 50 middle layer 30, there is less need for the inner wall 40 to be metallized in situations where it is desired to maintain the temperature of the contents container below ambient temperature.

Of course, where it is desired to maintain the temperature 55 of the contents of the container above ambient temperature (for example, to prevent freezing of the contents in extremely cold conditions), then it is preferable for the inner wall to be metallized, to prevent heat escaping from the contents through infrared radiation. Additionally, there is 60 less need for the outer wall to be metallized in these conditions. Of course, if the outer wall is not metallized or provided with a metallic foil layer, then the metallized or metallic foil layer of the inner wall can be used to form an electrostatic shield as discussed above. 65

To allow the container to be used whether the temperature of the contents is to be maintained above or below

ambient temperature, both the inner and outer walls can be metallized, to reduce heat transfer by means of radiation either to or from the contents of the container. The less radiation that passes through the inner or outer walls, the less radiation there is to be absorbed, reflected or scattered by the insulating material, and this reduces the conductive heat transport load.

In the manufacture of the container, the inner and outer walls are formed separately. Machined blocks of the expanded silica material are loaded into the floor region and around the sides of the outer wall, and the inner wall is then inserted.

The inner and outer walls 20, 40 are then connected together so that they form a gas- and liquid-impermeable envelope around the middle layer 30. This can be done in a number of ways. For example, welded metallic seals can be used, although this then provides a path of heat conduction into the container. As an alternative, preformed neoprene seals can be bonded to both the inner and outer walls, and this method of sealing substantially reduces heat conduction. In addition, if laminated materials are used to form the inner and outer walls, these can themselves be formed into lips and seals, which can then have an overlaying neoprene layer applied to them to seal them fully. The use of a neoprene layer can also enhance the sealing between the base and the lid of the container when it is closed, as the neoprene layer may be positioned where the base and the lid abut.

To further enhance the insulating properties of the container 10, the envelope is evacuated to a fairly high vacuum, such that the pressure is preferably less than 0.1 mm Hg (0.13 millibars or 13 Pa). The evacuation of the envelope substantially reduces convective heat transfer through the middle layer. It will be appreciated that it is necessary for the inner and outer walls 20, 40 to be impervious to gases in order to create a vacuum inside the envelope. It will also be appreciated that, since any puncture of the envelope will lead to loss of the vacuum, it is important for the outer wall 20 in particular to be strong and puncture-resistant.

Once the vacuum has been established, external atmospheric pressure will tend to push the outer wall inwards. Similarly, atmospheric pressure inside the container will tend to push the inner wall outwards. The tendency for the walls to collapse towards each other is resisted partly by the inherent strength of the walls, and partly by the presence of the insulating material. Because the insulating material helps to resist the compressive forces caused by atmospheric pressure, the walls may be thinner and hence more lightweight than would otherwise be the case.

A passageway 42 is provided in the inner wall 40. This passageway is provided with a valve 44, which is normally closed. The passageway 42 can be connected to a vacuum pump and the valve 44 opened to allow initial evacuation of the space between the walls. In addition, the passageway 42 can be connected to a pressure gauge, allowing the degree of vacuum in the space to be checked. There will inevitably be some leakage through the inner and outer walls 20, 40, and this will tend to degrade the vacuum in the space. If a check shows that the vacuum in the space has become too degraded, the vacuum pump can be reconnected to evacuate the space again and restore the vacuum.

As mentioned above, the expanded silica material is porous, and so the gases in the pores of the material must be removed when the space between the inner and outer walls is evacuated. A small recess 32 in the expanded silica material is shown opposite the passageway 42 in FIG. 2. This provides a greater surface area of the expanded silica material for the vacuum to act upon, and so assists in the