FR2850364A1 - Insulated outer container for transporting unstable blood products comprises foam-lined case with inner recesses for pouches and temperature controller - Google Patents

Abstract

The container (1), designed to open and close like attache case, is made from molded plastic with inner foam lining (3). It has inner recesses (4,5,6) shaped to receive a pouch of red corpuscle concentrate, at least1 pouches of eutectic products, and temperature controller, and a channel (7) through foam for temperature measuring probe (8). The container (1), designed to open and close like attache case, is made from molded plastic with inner foam lining (3). It has inner recesses (4,5,6) shaped to receive a pouch of red corpuscle concentrate, at least1 pouches of eutectic products, and temperature controller, and a channel (7) through foam for temperature measuring probe (8). A separate plate of a flexible plastic material allows any direct contact between eutectic product and blood product pouches to be avoided when case is closed and during use.

Description

Description

  The present invention relates to an insulated overpack intended for the transport of Labile Blood Products, integrating a device for measuring, recording, alerting and restoring temperature conditions inside the overpack.

  This invention is particularly suitable for the transport of bags of Concentrates of Red Globules (commonly called 'blood bags') and can, by extension, be used for the transport of all types of bags of body fluids, including the conditions of temperature preservation are similar to those of Labile Blood Products. 10 The object of this invention is to solve the technical problem faced by Blood Transfusion Establishments (hereinafter referred to as 'ETS') in the delivery process of Red Globule Concentrates (hereinafter referred to as 'CGR' and more commonly known as 'blood bags') at health care facilities - such as hospitals, 15 clinics or mobile care units - with a view to transferring these RGCs to a patient.

  As a preamble to the statement of the state of the prior art, it should be specified that the CGRs are products obtained from blood donations, which, once qualified and treated by the ETS, are intended to be transfused to patients . One of the particularities of CGRs is that they are particularly sensitive to the conditions of storage temperature and must therefore be constantly and strictly stored between + 20C and + 80C so as to present no risk of complications for the recipient of the transfusion ( Note that the storage temperature interval defined above is that applicable in France, and can vary by 1VC according to the regulations of foreign countries).

  ETS - which are the only bodies legally authorized to collect, process, store and distribute CGRs - are obviously organized internally in order to strictly comply with these temperature conditions for the conservation of CGRs at their disposal.

  However, blood transfusions are not carried out by the ETS themselves, but by healthcare establishments located throughout France (ie almost all blood transfusions are in fact carried out during surgical procedures), ETS therefore distribute these CGRs to healthcare establishments which have requested them.

  For this delivery of CGR, the ETS use, depending on regions and habits, plastic bags, insulated cardboard packaging for single use or sometimes coolers.

  Given these practices, ETS are thus faced with the problem of ensuring that the CGRs are kept within the required temperature range (between + 20C and + 80C), once they have been dispatched by their service delivery and pending a possible transfusion to a patient - a period which can last several hours.

  Today, no reliable device can guarantee this conservation of CGRs in the required temperature range until their effective transfusion to a patient.

  In addition, the problem is all the more acute for the ETS, as the CGRs delivered to 1o healthcare establishments are not systematically transfused: healthcare establishments indeed order CGRs when there is a risk of transfusion during scheduled surgery, but this risk is rarely a certainty.

  Thus, if during the surgical intervention, it turns out that the patient's condition does not require a blood transfusion - or does not require the transfusion of all of the 15 RGCs delivered by the ETS, the healthcare establishment is found with unused CGRs which he must either destroy or return to 'ETS which delivered them.

  When the ETS receive returns from CGRs that they have previously delivered to healthcare establishments and which have not been used by them, the ETS-cannot guarantee with certainty that these CGRs have been kept in the meantime required temperature 20 of [+ 20C; + 80C] - are forced to destroy them by application of the precautionary principle and in accordance with the 'guide to good delivery practices', drawn up by the French Blood Establishment for ETS.

  The present invention solves these problems encountered in the transfusion chain, by allowing the control and guaranteeing the total traceability of the conditions of temperature of conservation of the CGR, until the moment of the effective transfusion or, if necessary, until the return. to ETS of unused CGR.

  The object of the invention is thus to be used as an individual over-packaging of a CGR bag for the delivery thereof from PETS to a care establishment, and during their possible storage in the latter pending transfusion, then if necessary until return to the ETS in case of non-transfusion of the CGR bag.

  In addition to constituting a rigid shell protecting the pocket of CGR installed inside of the shocks or involuntary mistreatment during their transport and their storage in the establishments of care - as well as constituting an overpack with specific isothermal properties. The invention is specifically instrumented with a temperature control block which measures the storage temperature at regular intervals precisely within the interior housing for the CGR bag.

  The invention also has an alarm visible from the outside, in case the temperature conditions required and set have not been met.

  This alarm therefore makes it possible, until the moment of the transfusion act in the operating room, to guarantee that the conditions of storage temperature of the CGR bag have been respected during transport from the ETS and storage within the care establishment.

  I0 In addition, the temperature measurements taken inside the overpack and as close as possible to the CGR bag are stored by the integrated temperature control block, and can be retrieved on a computer by means of an interface. data exchange by infrared: this device therefore allows the ETS to have complete and documented traceability of the temperature conditions for storage of the CGR bag when it has not been used and is returned to them by a healthcare facility.

  Having these means of measuring, storing and restoring the conditions of temperature conservation of the CGR, the ETS can thus determine in a documented and proven manner whether the unused CGR bag can be reinstated in their stocks or whether it must be destroyed.

  For optimal use of the device, the assurance for ETS that the unused CGR pocket which is returned to them is the same as that which they delivered beforehand, will be made by three means, either: - l identification of the CGR bag by its Unique Donation Number (or any other suitable unique identifier) which is recorded on the temperature control block of the device (cf. infra) at the time of preparation of the device, - a system seal specific to each ETS attached to the handle at the time of preparation, guaranteeing that the device was not inadvertently or maliciously opened during transport and storage in the care establishment, - a visual check of the history of the device's internal temperature measurements once they have been transferred from the temperature control unit to a computer, making it easy to identify any opening of the device in a s years controlled temperature, by the sudden variation of the recorded temperature measurements.

  Composed of a rigid polypropylene shell having the form of an attachment and opening like the latter, and coated inside with a polyurethane foam having 5 insulating properties, the invention has two main housings on the inside: one intended to receive the pocket of CGR, the other intended to receive pockets of eutectic products, the melting point of which can be between 20C and 60C.

  These two housings are separated by a removable and flexible plate of cross-linked polyethylene foam intended to avoid any direct contact between the pocket of CGR and the pocket (s) of eutectic products, during transport, handling and storage. of the device used.

  The overpack is also equipped with a temperature control block fitted with a measurement probe, which passes through the polyurethane foam lining for a sheath provided for this purpose, in order to measure the temperature inside the pocket for the 15 CGR pocket, or as close as possible to the latter. A projection is provided at the point where the probe of the temperature control block emerges in the housing for the CGR bag, so as to promote contact between the measurement probe and the CGR bag itself, for better relevance of the measures.

  In addition to the measurement probe described above, the temperature control unit has a second temperature sensor installed in the housing, ie outside the thermally insulated housings. If the storage temperature limits of the CGR bag are exceeded, the recording of the measurements of this second “external” sensor will allow the ETS to refine the diagnosis of any possible exceedances 25 observed.

  Equipped with a self-contained lithium battery and integrating a 64K memory block - expandable if necessary to 256K - the temperature measurement block thus records the temperatures regularly measured by the two sensors described above.

  The operating parameters of the control block can be modified by authorized users, and in particular the following parameters: High and low temperature limits of the outdoor sensor, and possible integration of overshoots, - High and low temperature limits of the indoor sensor to the device (ie with probe), and possible integration of overshoots, 1 5 - Frequency of measurements for the two sensors, - Delay of neutralization of the temperature measurements of the sensors during the start-up phase of the control block, Identification of the pocket of CGR transported (for example, by recording the Unique Donation Number, characterizing each pocket of CGR).

  The cylindrical housing of the temperature control block is machined so that one of its faces has a shoulder: the rigid shell of the overpack is cut to the size of the cylinder of the housing at the housing of the control block , which therefore allows the face of the housing with the shoulder to be present on the outside of the overpack and to be glued to it.

  This original arrangement of the control block with a face visible from the outside of the overpack allows, without requiring the opening of the overpack (and therefore without risking degrading the internal temperature conditions): - to put into operation or when the control block is stopped by means of a push button, - instantly checking that the CGR bag is properly stored by means of an alarm LED, which is automatically triggered when the temperatures measured by the sensors - and more particularly the sensor inside the housing of the CGR pocket - exceed the limits and integration of set overruns, - transfer to the computer by means of a specific interface, the history of the temperature measurements stored by the block control, by means of an infrared exchange window.

  - initialize and configure the control block according to the non-exhaustive parameters defined above by means of an infrared exchange window.

  The accompanying drawings illustrate the invention: FIG. 1 represents a vertical view of the open device FIG. 2 represents in horizontal section a view along AA of FIG. 1 FIG. 3 represents a vertical view of the closed device (face 'control block of apparent temperature).

  Figure 4 shows the removable and flexible plate of cross-linked polyethylene foam.

  With reference to these drawings, the rigid polypropylene shell (1) is molded as a single piece, including the hinges (10), the clasp mechanism by 2 tabs (13) being inserted into two projections (12) provided for this purpose. and the handle shape (11) facilitating the gripping and handling of the overpack.

  This rigid shell (1) is coated in its inner part with a polyurethane foam (3) with isothermal properties; this polyurethane foam padding (3) has a specific housing for the CGR bag (4), a specific housing for the bag (s) of eutectic products (5), as well as a specific housing for the block of temperature control (6).

  The measurement probe (8) of the temperature control block (6) passes through the polyurethane foam (3) by a sheath (7) specially arranged in the latter and caulked at these ends, in order to measure the temperature precisely within the housing for the CGR pocket (4).

  A specific projection (9) is moreover provided within the housing of the CGR pocket (4), making it possible to favor the contact of the measurement probe (8) of the temperature control block (6) with the pocket of CGR, for better relevance of the measures.

  A flexible plate of cross-linked polyethylene foam (2) is also provided in the device in order to avoid any direct contact of the pockets of CGR and the pockets of eutectic products during transport: this plate is however removable and is shown separately in in figure 4.

  The rigid shell (1) is cut precisely to the dimensions of the cylindrical housing of the temperature control unit (6) so that one of the faces of this housing is visible from the outside of the overpack and is accessible to an operator without requiring the opening of the overpack.

  A machined shoulder (14) on the face of the case of the emerging temperature control block outside the overpack (6) allows this case to be bonded to the rigid shell (1), making it integral with the device and allowing repeated presses on the temperature control unit (6) without risk of sinking inside the device.

  The face of the temperature control block (6) emerging outside of the overpack 30 has a push button (15), two LEDs (16 and 17) and a data exchange window by infrared (18): - The push button (15) enables the temperature control unit to be switched on or off, or to configure it in the infra-red data exchange position.

  - A led (16) is an alarm indicator in the event of an overshoot of the set temperature limits or of the integration of the overshoots.

  - A led (17) is an indicator for switching on the temperature recorder sensor and for setting the infra-red data exchange position, - The infra-red data exchange window (18) allows data transfer and the parameterization of the temperature control block by means of a specific interface.

Claims (6)

claims   1) Over-packaging in molded polypropylene having the shape and the opening and closing characteristics of a briefcase (1) intended for the transport of bags of 5 Concentrates of Red Globule coated in its internal part with polyurethane foam ( 3), characterized by: - an interior housing specially designed to collect a bag of Red Globule Concentrates (4), - an interior housing specially designed to receive one or more bags of 10 eutectic products (5) - an interior housing specially designed to place the temperature control block (6).   - a sheath (7) passing through the polyurethane foam and allowing the passage of a measurement probe (8) connected to the temperature control block (6) and making it possible to measure the temperature within the housing of the concentrate bag of Red Globule (4).   2) Device according to claim 1 characterized by a flexible and removable plate of crosslinked polyethylene (2) making it possible to avoid any direct contact between the pocket (s) 20 of eutectic products and the pocket of Red Globule Concentrates, at the closing and during the use of the device.   3) Device according to claims 1 characterized in that the temperature control unit (6) has two temperature sensors: - one for measuring the temperature in the housing of the temperature control unit (5), that is to say outside the thermally insulated housings of the device, - the other making it possible to measure the temperature inside the housing of the CGR bag (4) by means of a specific measurement probe (8) passing through the polyurethane foam (3) by a sheath (7) provided for this purpose.   4) Device according to claims 1 and 3 characterized in that the temperature control block (6) also has: - a self-contained lithium battery and a memory block of at least 64 KB allowing record the temperatures measured by its two integrated sensors, an infrared data exchange window (18) allowing the transfer of recorded temperature measurements to a computer by means of a specific interface, - a possibility for configuring the control block by means of the infrared data exchange window (18), and in particular the following parameters: - High and low temperature limits of the external sensor, and possible integration of overshoots, - Limits of high and low temperature of the sensor inside the device (ie with probe), and possible integration of overshoots, - Frequency of measurements for both sensors - Delay of neutralization of temperature measurements s sensors during the start-up phase of the control block, - Identification of the pocket of CGR transported (for example, by recording the Unique Donation Number, characterizing each pocket of CGR) 5) Device according to claims 1, 3 and 4 characterized in that one of the faces of the temperature control block (6) is visible from the outside of the overpack which allows, without requiring to proceed to the opening of the overpack: - to put the control unit on or off by means of a push button (15), - to instantly check the good conservation of the CGR bag by means of a led d alarm (16), which is automatically triggered when the temperatures measured by the sensors - and more particularly the sensor inside the housing of the CGR pocket - exceed the limits or the integration of set overruns, - transfer on a computer by means of a specific interface, the history of the temperature measurements stored by the control block, and this by means of the infra-red data exchange window (18).   - initialize and configure the control block, using the infrared data exchange window (18).   4 10 6) Device according to claims 1 characterized by a specific projection (9) within the housing of the pocket of Red Globule Concentrates intended to promote contact between the probe of the temperature control block (8) and the bag of Concentrates Red blood cell.