EP0900072A1

EP0900072A1 - Refrigerated and tropicalized container for storing and transporting heat-sensitive products

Info

Publication number: EP0900072A1
Application number: EP97918204A
Authority: EP
Inventors: Jean Pacault
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-04-12
Filing date: 1997-04-11
Publication date: 1999-03-10
Anticipated expiration: 2017-04-11
Also published as: DE69701096D1; EP0900072B1; DE69701096T2; ES2143858T3; WO1997038661A1; ATE188371T1; FR2747377B1; FR2747377A1

Abstract

The invention features a container (1) for the temporary storage and transport of heat-sensitive products under conditions such that there is no break in the chain of required temperatures, particularly applicable to unstable blood products when they are being transported from centralised blood banks to surgical centres or even within the same facility from the storage area to the various operating theatres. The said container consists of an isothermal, sealed box (2) opening at the top, connected to a motor-compressor unit (9) generating inside the box (2) negative kilo calories to a set temperature. The box (2) is equipped with a calorie-generating unit (10) which stirs the air inside the box (2) to provide for a rapid adjustment of the internal temperature to a preset value in the range of -30 DEG C to +40 DEG C.

Description

REFRIGERATED AND TROPICALIZED CONTAINER FOR THE STORAGE AND TRANSPORT OF THERMO-SENSITIVE PRODUCTS

The invention relates to a thermostatically controlled container for the temporary storage and transport of thermo-sensitive products in order to guarantee total compliance with the recommended temperature chains. The problem arises in particular for the transport of labile blood products, not only in the case where it is advisable to supply surgical centers from centralized blood stores, but also when inside a same hospital establishment, there sensitive products should be circulated, for example from their place of conservation to an operating theater.

Generally, all medical or surgical products thus transported must meet very strict temperature criteria; for example, the temperature of red blood cell concentrates should be between 2 ° C and 8 ° C; for platelets between 20 ° C and 24 ° C; for plasmas, a temperature close to -25 ° C, etc. must be observed. It is also well understood that the movement of such heat-sensitive products from a storage point where they are kept at the appropriate temperature, to a point of use which can be very far away leads to borrowing various means of transport and, preferably, the fastest, which implies transshipments, transport times, waiting or transit times, and naturally manipulation times to coordinate the whole; it is obviously during all these successive manipulations that there may be a break in the chain of temperatures required taking into account the product transported. This rupture is often effective as soon as the correct temperature of the product is even momentarily changed by 1 or 2 degrees, which, it is easily agreed, is a permanent danger. So far, to transport such products, under the conditions mentioned above, the means used were, to say the least, very rudimentary, consisting mostly of using an ice box, or a container filled with ice or carbo-ice, inside which the product was placed, temporarily sheltering it from all external aggressions. Of course, when the product requires transport at a positive temperature, which is for example the case of labile blood products (PSL) which must not drop lower than 20 ° C or rise higher than 22 ° C, then the only ones solutions known to date consisted of transporting the products in insulated cases as quickly as possible, by taxi, by special courier or other rapid transport, in the hope that the thermal inertia of the insulated containers would be sufficient to guarantee an internal change in temperature sufficiently slow compared to the duration of the transport.

In practice, the previous systems consisted of constant vigilance so that the products handled circulate as much as possible at the required temperatures, even if it means interrupting this or that phase of transport, to temporarily restore the ambient necessary for the good survival of the products. thus displaced.

The present invention aims to overcome all these drawbacks by proposing a sealed and thermostatically controlled container designed to precisely maintain an internal temperature at any value between two extreme temperatures (-30 ° C / + 40 ° C) whatever else the various handling phases: internal handling on a trolley providing autonomy of supply, external handling by connection to a specialized vehicle for their transport; naturally, the intermediate manipulations to pass, for example, from an establishment to a vehicle or the reverse are simply ensured by the thermal inertia of the container, calculated for this purpose.

In this regard, the container for the temporary storage and transport of heat-sensitive products in conditions of total continuity in the required temperature chain, comprising a box isothermal and watertight with upper opening, coupled with a motor-compressor unit producing inside the box of frigories until reaching a predetermined temperature is characterized in that the box is equipped with an assembly producing calories which, by circulating the air inside said box, allows a rapid adjustment of the internal temperature to a programmed setpoint between -30 ° C and + 40 ° C.

It is now understandable that the container according to the invention allows, within relatively short times, to maintain a very precise temperature inside the box by means of a programmable regulating thermostat coupled of course with conventional alarm systems. promptly warning of any false maneuvers, or even operating incidents.

According to a particularly important variant of the invention, the source of production of calories making it possible to raise the temperature values inside the box is obtained by the advantageous combination of a halogen lamp, housed in a nozzle arranged vertically to allow the by means of a simple axial fan, to drive the upper layers of air from the container downwards in order to create a forced convection of the fresh air that we want to heat.

A decisive advantage of this device, in addition to its simplicity, lies as will be said later in the exceptional flexibility of the thermal inertia of the heating element when the latter is activated for thermal regulation. In addition, a halogen lamp of the type that is mounted in a motor vehicle headlamp has a particularly stable consumption preserving the autonomous battery supply devices. In addition and additionally, it is possible to use the two filaments corresponding to the main beam and the dipped beam separately, or even to put them in series or in parallel, so as to influence the intensity and therefore the slope. heating temperature variation. According to another additional variant of the invention, provision is made to equip the tropicalized refrigerated container with an autonomous agitator which is particularly suitable for products such as PSL which it is known that they must be agitated as soon as the transport times exceed two hours; the agitator accessory according to the invention is advantageously obtained by an adequate device making it possible to hold the pockets of PSL which will thus be tilted, back and forth or in rotation by a simple spit motor, with continuous rotation or alternated.

According to a secondary characteristic of the invention, it is possible to bring inside the refrigerated and tropicalized containers a special double-walled container and also double-walled cover, filled between walls with a heat-transfer fluid such as mono-ethylene. glycol.

This special tank allows in particular the packaging on the storage site of the heat-sensitive products that one wishes to transport later; in this way it suffices, at the desired time, to have the container, previously filled with the products to be transported, inside the container, which avoids filling times which are always detrimental to compliance with the temperature chain; on the other hand, the use of the special container, at the time of unloading, can prove to be extremely useful, insofar as it is easy to handle, it can be transported more quickly to a specific place which would be, for example, difficult to access by the container and its accessories on a cart; finally, an advantage which is always important in the case of transport of sensitive products such as platelets, plasma and other implants, lies in the ease of maintenance and asepsis of the materials; for this purpose, a self-contained container, for example made of 316 L food grade stainless steel with no internal irregularities, can be used inside the containers or in combination with the special container; this small stainless steel tank can be more easily inserted into an autoclave for perfect disinfection.

Another particularly interesting advantage of special tray is to be able to make it photo-opaque, which is particularly necessary for the transport of products deteriorating in the light, such as for example the plates. Other characteristics and advantages will emerge from the description which will be given of a preferred example, although not limiting, given for the purpose of illustrating the invention with reference to the appended drawings in which: - Figure 1 is a perspective view of a container according to the invention schematically showing the location of the cold source and the hot source, associated with the supply, programming and control device. - Figure 2 shows in elevation and in vertical section along the line II-II of Figure 3 the container according to the invention.

- Figure 3 shows a top view and in horizontal section along the line III-III of Figure 2, the container according to the invention.

- Figure 4 shows a top view in partial section IV-IV of Figure 2, the heating element mounted inside the ventilation duct.

In accordance with FIG. 1, the container 1 according to the invention consists of a box 2 provided with four vertical walls 3 and a bottom 4, the upper part of the box 2 being closed by a cover 5 which is advantageously foldable and lockable by conventional means of hinges 6 on one side and a rocker toggle 7 on the other.

Inside the box 2, at least one vertical lateral face 3 is provided with an evaporator 8 supplied by a motor-compressor unit 9 calculated to provide a sufficient cold source inside the box 2. It is quite obvious that the vertical evaporator 8 can be arranged on any lateral face 3 and in a particularly advantageous variant, the four vertical faces can thus be equipped with evaporator 8.

In a corner of box 2, we have a set heating 10 so that the hot air can be drawn from the lower part of the box 2 towards the bottom 4 which for this purpose will advantageously have grooves 11 thus providing circulation spaces for the air drawn in accordance with the arrows materializing the convection of air inside the box 2 in FIG. 1.

Positioned as far as possible from the hot spring, preferably in the center of the side face 3 affixed to the heating assembly 2, a temperature sensor 12 will indicate at all times, the temperature prevailing inside the box, this probe being chosen because of its extreme precision, for example to the nearest half degree.

A processor 13 having its own operating autonomy 14 will be programmed to maintain with an accuracy of half a degree, an internal temperature in the box 2 conforming to the set temperature 15 required for the temporary storage and / or the transport of heat-sensitive products. without the slightest break in the cold or hot chain; of course this set temperature can be adjusted by means of a manual or automatic inverter 16 regulating the temperature either by means of the cold source 9 or by means of the hot source 10, the two sources being unable to cooperate simultaneously. Of course, the display temperature is directly accessible from the outside by means of the adjustment buttons 17.

The supply of the hot source 10 and the cold source 9, in 12 or 24 volts, is conventionally obtained by a battery 18, and the processor 13 checks at all times the state of charge of the battery 18.

Incidentally, an alarm device 19 advantageously completes the processor 13 when the latter detects by means of the thermostatic probe 12 an abnormal change in temperature during a transient or transport regime; in addition, the alarm 19 will be triggered when the charge of the battery 18 is critical, giving the user the time necessary to get as quickly as possible to a charging station 20 which by nature can only be a fixed station. The assembly thus constituted by the container 1 provided with its hot 10 and cold 9 source, its processor 13 and its accessories as well as its power supply 18 can be easily grouped together on a displacement trolley making handling of the together in all the intermediate phases between storage or use and the transport periods.

For clarity of the drawings, the carriage carrying the assembly which has just been described has not been shown. With reference to FIGS. 2, 3 and 4, each element of the container 1 according to the invention will now be described in detail.

The box 2 and its cover 5 are made from an isothermal sandwich conventionally based on thermoplastic materials for the internal and external walls trapping a polyurethane foam. The cover 5 articulated by hinges 6 to the box 2 can be folded tightly over the upper part of the box 2 by means of a double O-ring 21 cooperating with a safety closure of the toggle toggle type 7.

Printed on at least one of the side faces 3 of the box 2, one or more evaporators 8 are connected to a motor-compressor unit 9 arranged outside the container 1. The bottom 4 of the box 2 is advantageously provided with grooves 11 allowing sufficient air passage under the stored products. In order to prevent the products from coming into direct contact with the vertical evaporator (s) 8 it is advantageously provided to have a vertical grid 22 in front of each evaporator a few millimeters away.

It will be observed that the production of frigories is obtained by the cooperation of the motor-compressor group 9 with the evaporator (s) 8 arranged on the lateral faces 3 of the box 2, the whole being of a type quite common in terms of refrigerator- freezer; of course, group 9 is calculated and generally arranged in such a way that it is possible to reach inside the box 2, hermetically closed, a minimum temperature of -30 ° C.

The heating assembly 10 equipping the containers 1 is obtained from a simple low-voltage lamp 23 of the type of H4 halogen lamps commonly used today in motor vehicle headlamps. The halogen lamp is placed inside a support tube 24 produced for example from a PVC pipe with a diameter of 60 mm over a height a few centimeters lower than the useful height of the box 2; in the upper part of the duct 24 is arranged a helical fan 25 operating at low voltage simultaneously with the lamp 23 so that the upper air layer of the box 2 is sucked in at the top of the tube 24 and expelled in the direction of the lamp 23 in order to be heated there by simple contact, lights 26 arranged in the lower part of the tube 24 ensuring the escape of the air thus heated and its distribution in the bottom 4 of the box 2 creating in contact with cooler air masses staying there a real convection triggering a progressive rise in the temperature of the box.

It will be noted that the fan 25 is in this case a simple fan conventionally used for cooling electronic circuits; similarly, the halogen lamp 23 fixed vertically, active part upwards towards the fan at about half height of the tube 24 by means of a cup 27 supporting in the center a standardized socket 28 making it possible to receive the base of the lamp H4 23 in accordance with the diagram shown on a larger scale in FIG. 4. The cup 27 of the lamp 23 includes lights 29 distributed all around the lamp 23, ensuring the exhaust of the air flow drawn by the fan 25, previously heated by the external envelope of the lamp 23.

As regards the tube 24 playing here in a way the role of a nozzle, this is maintained on the bottom 4 of the box 2 by means of three fasteners 30, preferably in an angle of the box 2 not taking as well as a minimum of space. The lights 26 for expelling the hot air have been calibrated for optimal distribution of the air in the bottom of the box.

The heating element constituted as seen by a simple lamp 23 of the H4 type proves to be particularly advantageous insofar as there are two filaments corresponding to the main beam and the low beam on a motor vehicle; of course, it is entirely possible to play, thanks to these two 55-watt filaments, on the calorific power delivered by the lamp 23; it was nevertheless preferred to power the bulb 23 by putting the two filaments in series in order to increase the ignition inertia and thus make the maximum power coincide with the maximum speed of the air flow provided by the fan 25 when it reaches its nominal power. This inertia in the lighting of the lamp 23 also very advantageously ensures progressive reheating, smoothly, which, conversely, can be extremely harmful for certain heat-sensitive products. In addition, it is clear that the placing in series of the two filaments has the secondary effect of reducing the light intensity of the lamp 23 which avoids any deterioration when the products are not photo-resistant. Under the conditions which have just been indicated, and for a box representing an internal volume of 50 liters, the tests have shown that with a fan whose nominal flow rate is 12 nr / H, it was possible without any difficulty to increase the internal temperature of the closed box from 18 ° C to 40 ° C, so that by combining the two systems supplying frigories, supplying calories, the temperature range that can be maintained in the same container will be -30 ° C to + 40 ° C.

By way of example, temperature tests were carried out on a container according to the invention taken at an ambient temperature of 20 ° C., to bring it to a programmed temperature of -30 ° C. After switching on 12 Volts DC by an autonomous battery supply, the temperature of -30 ° C was reached 1 hour and 35 minutes later.

Other temperature rise tests could be carried out showing that to go from an internal temperature in the box of 4 ° C to an internal temperature of 14 ° C, 55 minutes were sufficient.

Incidentally, it is planned to couple the processor 13 with an alarm device 19 allowing on the one hand to permanently check the state of the batteries but also to ensure a permanent control of the temperature variations by setting off for example an alarm programmable sound according to the limits prescribed by the user.

Various accessories complete container 1; it is first of all an agitator for labile blood products essentially intended to create a movement either from top to bottom, or from right to left, or a rotary movement or a vibration movement for the blood bags which are, moreover, contained in a plastic tank. This tank is then subjected to an eccentric drive system or any other drive system of the reciprocating type driven by an electric motor with autonomous continuous supply, of the type commonly used for spit makers. The driven system is placed on two plastic flanges to create a rigid cradle which is then placed in a block inside the container before closing and transport.

Another advantageous accessory can be used in combination with the containers; it is a self-contained container, not shown in the drawings, making it possible to pre-condition the products to be transported prior to their storage in the containers, that is to say in places particularly suitable for their handling; this autonomous tank itself comprising a box and a lid with safety closure, has double walls delimiting between them a space filled with a heat-transfer product of the mono-ethylene glycol type making it possible to accumulate frigories or calories, as we know. The advantage of this bin is to facilitate loading and unloading operations, while also giving the possibility of transporting without risk of breaking the temperature chain of temperature-sensitive products, wherever the size of the containers would prevent their passage . This is particularly the case of corridors and doors in some hospitals to reach the operating room.

In the alternative, note ¹ that this particular autonomous tank is provided with an internal temperature sensor, coupled with a display, preferably digital, of the temperature allowing throughout the transport to verify the perfect maintenance of the set temperature.

Claims

1 - Container (1) for the temporary storage and transport of thermosensitive products under conditions of total continuity in the required temperature chain, comprising an insulated and waterproof box (2) with upper opening, a cold source (9) consisting of at least one evaporator and a motor-compressor unit, producing inside the box (2) frigories until reaching a predetermined temperature, and a heating assembly (10) housed inside the box ( 2) to produce calories and to allow rapid adjustment of the internal temperature to a programmed setpoint between -30 ° C and + 40 ° C, characterized in that the heating assembly (10) comprises a heating element (23), arranged in a cylindrical nozzle (24), positioned vertically inside the box (2), and a fan (25) arranged at the upper inlet of the same nozzle for sucking the air in the upper part, propelling it to the inside laughing nozzle (24) on the heating element (23) and finally eject it in the lower part of the box (2).

2 - Container (1) according to claim 1 characterized in that the heating element (23) is a lamp, preferably halogen.

3 - container (1) according to claim 2 characterized in that the halogen lamp (23) is a lamp with two filaments of the type fitted to the headlights of motor vehicles of which one uses either a single filament or both, put in series or in parallel.

4 - Container (1) according to any one of the preceding claims, characterized in that the internal walls (3) of the box (2) are provided with grids (22) of the lattice type to prevent any contact of the heat-sensitive products with the refrigerated walls and ensure proper circulation of indoor air.

5 - Container (1) according to any one of the preceding claims, characterized in that the bottom (4) of the box (2) is provided with grooves (11) allowing the passage of air under the stored products.

6 - container (1) according to any one of the preceding claims, characterized in that the thermal regulation inside the box (2) is obtained from an internal thermostatic sensor (12), preferably arranged at the opposite to the heating assembly (10), acting on a programmable processor (13) controlling either the heating element (23) and the fan (25) or the cold source (9), in order to reach as quickly as possible the desired setpoint temperature (15) inside the box (2). 7 - Container (1) according to any one of the preceding claims, characterized in that an autonomous agitator is provided for liquid products and particularly for labile blood products.

8 - container (1) according to claim 7 characterized in that the agitator consists of a rocking system giving the tank holding the product pockets, a reciprocating pendulum movement, or back and forth by means of a self-powered spindle motor with continuous or alternating rotation. 9 - Container (1) according to any one of the preceding claims, characterized in that a removable container, the box and the envelope of which are advantageously provided with a double wall which is photo-opaque and thermo-accumulating, trapping a heat-transfer liquid, for example mono-ethylene glycol, can be inserted inside the box (2) in order to speed up and facilitate the loading and unloading operations of the container (1) as well as its cleaning.

10 - Container (1) according to claim 9 characterized in that the removable tray is provided with an internal temperature probe coupled to a thermometer, for example digital, with external reading.