TRACEABILITY AND MONITORING OF A STERILISATION CASE AND THE CONTENT OF SAME

Abstract

The present invention concerns, in this example, a sterilization case (200) for surgical instruments (210) including an electronic identity device (100) for the monitoring and traceability of the case and the content of same, the electronic device (100) including:—a measurement module (10) for taking at least one measurement relative to at least one parameter representative of an environmental condition to which the sterilization case (200) is exposed and for generating an item of digital measurement data (D_M) depending on the measurement,—a storage module (20) for storing the generated item of measurement data (D_M),—a communication module (30) suitable for cooperating with the storage module (20) in order to transmit the item of measurement data (D_M) to an external reader (300, 300′) when the external reader (300, 300′) interacts with the communication module (30).

Claims

1-20. (canceled)

21. A sterilization container for surgical instruments comprising an electronic identity device for the monitoring and traceability of said container and of the instruments that it contains, said electronic device comprising: a measurement module configured to take at least one measurement relating to at least one parameter representative of an ambient condition to which said sterilization container and said instruments are subjected and generate a piece of digital measurement data on the basis of said measurement taken, a memorisation module configured to memorise said piece of measurement data generated, a communication module suitable for cooperating with said memorisation module in order to transmit said piece of measurement data to an external reader when said external reader interacts with said communication module, wherein said sterilization container comprises a protective case enclosing said electronic identity device, said case being at least partially formed from an impermeable and thermally insulating material in order to protect said electronic identity device, in particular when passing through an autoclave.

22. The sterilization container according to claim 21, wherein the protective case is at least partially formed from a material suitable for resisting pressures substantially between approximately 0 and 16 bar and/or temperatures substantially between approximately −20° C. and 200° C.

23. The sterilization container according to claim 21, wherein the protective case comprises two half-shells rigidly assembled to each other with a sealing joint.

24. The sterilization container according to claim 23, wherein the half-shells and the sealing joint are at least partially formed from at least one of the polymers chosen from the following: polysulfones, polyphenylsulfone resins, polyetherimides, polyamides, polyformaldehyde, butylene polyterephthalate.

25. The sterilization container according to claim 21, wherein said measurement module comprises a temperature probe.

26. The sterilization container according to claim 25, wherein said temperature probe comprises a thermostat configured to detect an ambient temperature outside of said protective case greater than a predetermined threshold temperature between 100° and 130° Celsius.

27. The sterilization container according to claim 26, wherein said protective case comprises an insert passing all the way through, made from a material suitable for conducting heat, and wherein said thermostat is in direct contact with said insert.

28. The sterilization container according to claim 26, wherein said protective case has a thinner section of wall, and wherein said thermostat is placed against the inner wall of said protective case at said thinner section of wall.

29. The sterilization container according to claim 21, wherein said measurement module comprises a pressure sensor.

30. The sterilization container according to claim 21, wherein said measurement module comprises a humidity sensor.

31. The sterilization container according to claim 21, wherein said measurement module comprises a vibration sensor.

32. The sterilization container according to claim 21, wherein said measurement module comprises an accelerometer.

33. The sterilization container according to claim 21, wherein said measurement module is synchronised with an internal clock in such a way that said piece of digital measurement data is timestamped.

34. The sterilization container according to claim 21, comprising, on one of its lateral walls, a reading zone having a matrix barcode, the optical reading of said code by an external optical reader triggering the transmission of the piece of digital measurement data to said reader.

35. The sterilization container according to claim 21, wherein said communication module is suitable for communicating with said external optical reader via a Bluetooth wireless communication protocol.

36. The sterilization container according to claim 21, wherein the electronic identity device comprises a processing module configured to process the digital measurement data memorised in the memorisation module and generate a warning signal when the data contains a piece of information that does not comply with a predetermined vigilance rule.

37. The sterilization container according to claim 36, wherein the electronic identity device comprises a warning module that cooperates with the processing module and is configured to emit an alert upon reception of a warning signal.

38. The sterilization container according to claim 21, wherein said electronic device comprises a rapid-recharge power supply module.

39. The sterilization container according to claim 38, wherein said power supply module comprises a thermoelectric generator configured to convert the thermal energy provided when passing through an autoclave into electric energy.

40. An Assembly for the monitoring and traceability of surgical instruments, comprising: a sterilization container according to claim 21 comprising said surgical instruments, and an eternal reader suitable for communicating with the electronic identity device of said container.

Description

BRIEF DESCRIPTION OF THE APPENDED FIGURES

[0128] Other features and advantages of the present invention will be clear from the following description, with reference to the appended FIGS. 1 and 2 that illustrate an example of an embodiment of the present invention that is in no way limiting and in which:

[0129] FIG. 1 shows a perspective view of a sterilisation container according to an example of an embodiment of the present invention;

[0130] FIG. 2 shows a schematic view of a sterilisation container according to FIG. 1.

DETAILED DESCRIPTION OF AN ADVANTAGEOUS EXAMPLE OF AN EMBODIMENT

[0131] A sterilisation container according to an advantageous example of an embodiment will now be described below, with reference to both FIGS. 1 and 2.

[0132] Designing an intelligent and autonomous sterilisation container that allows the composition of said container and its history to be known at any time is one of the goals of the present invention.

[0133] The applicant has observed that in hospitals and in particular in the sterilisation department, the operations for accurately knowing the composition of a container are very complex.

[0134] Moreover, it is very difficult to know and accurately verify the state of a container and of the instruments that it contains after prolonged storage; here, state means to verify that the container and the instruments that it contains have been stored and preserved in conditions that prevent any potential contamination.

[0135] Likewise, it is very difficult to verify that the decontamination and sterilisation cycles have been correctly carried out.

[0136] The underlying concept on which the present invention is based is that of designing a sterilisation container equipped with electronic and computer means acting as a “black box”.

[0137] This “black box” is an improved black box that must allow the relevant information (composition of the container, temperatures, pressures, humidity levels, shocks experienced, etc.) on the container 200 and on the instruments 210 that it contains to be provided at any time.

[0138] In the example described here, the first phase of disinfecting the surgical instruments 210 takes place in the operating room as soon as the operation is over or in a medical care department as soon as the procedure is over.

[0139] The instruments 210 used, which are contaminated, are submerged in a detergent-disinfectant solution.

[0140] This first precaution allows the proliferation of germs, the development of which is often exponential, to be combatted early on.

[0141] The instruments 210 are then handled:

[0142] either by the sterilisation department of the hospital;

[0143] or by a subcontracting service-provider company. In the example described here, the instruments 210 are then placed in a suitable piece of medical furniture (cabinets or carts) and pass through a professional medical washing machine such as a large washer/disinfector.

[0144] In the example described here, this machine operates with water called “reverse osmosis” water (that is to say, water from which scale and limestone have been chemically removed).

[0145] In the example described here, the protocol further comprises chemical washing at approximately 60° C. then disinfection at high temperature (approximately 93° C.).

[0146] These conditions must be meticulously respected in order to be compliant with health standards and prevent any health risk.

[0147] Upon exiting this machine, the instruments 210 have been decontaminated; they are then handled with great care under very strict hygiene conditions: the quality of the air is permanently controlled and employees wear special clothing in order to be able to carry out the step of reconditioning the instruments.

[0148] The operator in charge of the sterilisation of the instruments 210 then identifies each of the decontaminated instruments 210, for example using an ANCITRACK® apparatus or a WHITEREADER® apparatus.

[0149] This operator then places the instruments 210 in a sterilisation container 200 on suitable supports in order to form the container 200 for a programmed procedure.

[0150] This identification and rearrangement step allows a plan of the sterilisation container 200 to be established, with all the instruments 210 that it contains.

[0151] The computer system allowing this identification and rearrangement, for example ANCITRACK®, generates identity data containing the identification information that allows the monitoring and traceability of the container 200 and of the instruments 210 that it contains.

[0152] In the example described here, the complete container 200 thus rearranged is then:

[0153] either packaged in such a way as to respect the standards in effect, in sterile fields specifically designed for sterilisation (packaging that is impermeable once dry);

[0154] or inserted into a sealed container specially designed for sterilisation. Starting with this step, the approved container of these instruments is no longer visible and cannot therefore be controlled by conventional means (visual identification, WHITEREADER® or ANCITRACK®). In the example described here, the container 200 is then inserted into a steam autoclave; this sterilisation step involves bringing the container 200 to a temperature of 134° C. for a predetermined time, for example 18 minutes.

[0155] The pressure and humidity conditions are also controlled here in order to have sterilisation that meets the health standards in effect.

[0156] Once sterilised, the instruments 210 are ready to be used; the instruments 210 are then sent directly back to the users or are stored in suitable areas for an imminent upcoming operation.

[0157] These storage areas comply with very strict standards, in particular in terms of temperatures and humidity.

[0158] As indicated above, it is very difficult or even impossible to know the precise composition of the container for each container 200, or to know whether or not the decontamination, sterilisation or storage conditions have been respected or whether or not the integrity of the instruments 210 is still intact because of the packaging or the sealed container.

[0159] It is noted here that the field used is permeable to vapour once wet and becomes impermeable again once dry, the sealed containers are therefore containers having an aluminium filter (filter made from the same material as the packaging), and the filter is permeable to vapour once wet and becomes impermeable again once dry: for this reason, it is important to not exceed a certain humidity level during storage (doubts about the integrity of the impermeability).

[0160] Has the temperature of 134° C. for 18 minutes been reached during the sterilisation cycle? Has the humidity level during storage been respected? Today, it is impossible to answer these questions; this is even more so when these treatment services are subcontracted out to outside companies.

[0161] In the example described here, in order to overcome these various disadvantages, the container 200 is intended to be equipped with an electronic identity device 100.

[0162] This device 100 is characteristic of the present invention; it forms a real “black box” of the surgical instruments 210.

[0163] In the example described here, this device 100 consists of a measurement module 10. This module 10 is configured to continuously (or alternatively periodically) take at least one measurement relative to at least one parameter representative of an ambient condition to which the container 200 is subjected. In the example described here, these parameters are the temperature, the pressure, the humidity level, and the possible shocks to which the instruments have been subjected and that are capable of degrading the instruments.

[0164] It is understood here that other parameters can be probed in the context of the present invention.

[0165] In the example here, the measurement module 10 thus comprises a temperature probe 11, a pressure sensor 12, a humidity sensor 13, a vibration sensor 14 and an accelerometer (not shown here).

[0166] It is thus possible to know the temperature, pressure and humidity conditions, as well as the shocks to which the instruments 210 have been subjected, for example during the decontamination, cleaning or sterilisation cycles or during the phases of storage and/or transportation of the container 200.

[0167] These sensors 11, 12, 13 and 1 are configured to generate a piece of digital measurement data D_M on the basis of the measurement taken.

[0168] The digital data D_M is preferably timestamped.

[0169] This is made possible in the context of the present invention by a clock CLK internal to the device 100.

[0170] In the example described here, each of these sensors 11, 12, 13 and 14 is indeed synchronised with this clock CLK in order to have a timestamped piece of data D_M comprising, in particular, the time and date of the measurement.

[0171] This data D_M is then memorised by the memorisation module 20.

[0172] In the example described here, this module 20 comprises ROM electronic memorisation means.

[0173] These means thus store the measurement data D_M.

[0174] In the example described here, the device 100 provided in the container 200 further comprises a communication module 30.

[0175] In the example described here, this communication module 30 is suitable for communicating with the ANCITRACK® computer system in order to receive the identity data containing the information relative to the various surgical instruments 210 that the sterilisation container 200 contains.

[0176] This identity data is memorised in the memorisation module 20.

[0177] The memorisation module thus contains all of the information relative to the surgical instruments that the container contains and to the ambient conditions to which the container and these instruments have been subjected. This module 30 is preferably suitable for cooperating with the memorisation module 20 in order to transmit all of the measurement data D_M to an external reader 300 or 300′ when the external reader 300 or 300′ interacts with the communication module 30.

[0178] In the example described here, this module 30 comprises an antenna 31.

[0179] In this example, the memory module 20 may also comprise an electronic chip 21.

[0180] The chip 21 and the antenna 31 thus form an RFID radio-identification tag.

[0181] Thus, in order to know the information contained in the memorisation module 20 (here, the chip 21), the operator merely has to take an RFID reader 300 and recover the data D_M by bring this reader 300 close to the antenna 31.

[0182] The reader 300 generates an electromagnetic (or electric) field that then allows the transmission of the data D_M contained in the chip 21.

[0183] In other words, in this example, the communication module 30 comprises a receiver 31 of wireless communication such as an RFID antenna.

[0184] Other transmission modes can be imagined, for example BLE wireless communication (for “Bluetooth Low Energy”).

[0185] In this example, when a BLE reader 300 establishes communication with the receiver 31, the latter then transmits the digital data D_M contained in the memorisation module 21 to the reader.

[0186] In the example described here, it is also possible for the reading to be carried out via optical reading of a “DataMatrix” two-dimensional matrix barcode C_2D; such a code C_2D is present on at least one reading zone of the container 200.

[0187] In this mode, the operator scans the code C_2D and thus recovers all of the data D_M stored in the module 20.

[0188] As mentioned above, the communication module 30 can also communicate with the ANCITRACK® system.

[0189] It is thus possible to recover the information relative to the plan of the instruments 210 in the container 200.

[0190] In the example described here, the electronic identity device 100 comprises on-board intelligence in order to be autonomous and be able to provide a first level of diagnostics with regard to the risks encountered.

[0191] The device 200 thus comprises a microprocessor 40 allowing the memorised digital measurement data D_M to be processed. This microprocessor 40 verifies that the data D_M does not contain a piece of information that would not comply with a predetermined vigilance rule, for example a temperature not reached during the sterilisation phase, an insufficient sterilisation time, a shock capable of degrading the instruments contained in the containers, etc.

[0192] These rules predefined by the standards in effect are stored for example in the memorisation module 20.

[0193] If one of the pieces of information contained in the data D_M does not comply with one of the predetermined vigilance rules, the microprocessor 40 generates a warning signal SA.

[0194] In the example described here, the warning module 50 of the device 100 emits an alert Av such as, for example, a light alert upon reception of such a warning signal SA.

[0195] Via this microprocessor 40 and this warning module 50, the operator that receives the container 200 can immediately see whether the container 200 has been subjected to outside conditions (temperature, pressure, etc.) that would not comply with predetermined rules.

[0196] In the example described here, the warning module 50 may comprise a set of diodes such as a “green” diode and a “red” diode, the green colour corresponding to a compliant state and the red colour corresponding to a non-compliant state.

[0197] Thus, via this device 100 consisting of these various electronic modules, it is possible to equip the container 200 with on-board intelligence that facilitates the work of the operators tasked in the hospital compound with monitoring the compliance of the instruments 210 before a surgical procedure.

[0198] To withstand the ambient conditions (temperature, pressure, humidity), in particular when passing through an autoclave, the device 100 is placed in a protective case 110 consisting of two rigid half-shells (not shown here).

[0199] Preferably, half-shells made from a polymer suitable for resisting high temperatures and high pressures are provided. It is also intended for these half-shells to be assembled together via a sealing joint.

[0200] It should be noted that this detailed description relates to a particular example of an embodiment of the present invention, but that in no case should this description be in any way limiting to the object of the invention; on the contrary, its goal is to eliminate any possible imprecision or any incorrect interpretation of the following claims.