System for detecting and measuring the concentration of at least one sterilizing agent in gaseous state for a low-temperature sterilizer

Abstract

System (1) for detecting and measuring the concentration of at least one sterilizing agent (2) in the gaseous state for a low-temperature sterilizer comprising at least one emitter (3) of electromagnetic radiation with an emission frequency over a predetermined frequency range, at least one receiver (4) of said electromagnetic radiation capable of targeting a predetermined frequency of electromagnetic radiation and capable of emitting a signal, at least one signal processing device (5) of the receiver (4) capable of detecting and / or measuring the concentration of at least one sterilizing agent (2) as a function of its absorbance rate in the electromagnetic radiation frequency predetermined by the receiver (4), at least one sensor (6) arranged to capture in an area located between the emitter (3) of electromagnetic radiation with an emission frequency over a predetermined frequency range and its receiver (4),said zone positioned between the emitter (3) of electromagnetic radiation with an emission frequency in the predetermined frequency range and its receiver (4) defining a measurement zone (7) and at least one control unit (8) capable of modifying the target frequency of the electromagnetic radiation by the receiver (4). According to the invention, the control unit (8) is adapted to adjust the frequency of the electromagnetic radiation targeted by the receiver (4) as a function of at least one physical parameter measured in the measurement zone (7). Figure to be published with the abbreviation: Fig. 1,

Description

Title of the invention: System for detecting and measuring the concentration of at least one sterilizing agent in gaseous state for a low-temperature sterilizer

[0001] The invention relates to the technical field of systems for detecting and measuring the concentration of at least one sterilizing agent, more particularly at least one sterilizing agent in gaseous state for a low temperature sterilizer, in particular a surgical instrument sterilizer.

[0002] The invention also relates to a low temperature sterilizer comprising a system for detecting and measuring the concentration of at least one sterilizing agent in the gaseous state according to the invention.

[0003] Generally, sterilization processes are used in many applications, such as in food processing, packaging manufacturing, beverage filling, or the processing of medical devices, particularly surgical devices.

[0004] In order to rid them of microorganisms or germs capable of reproducing and creating health problems, it is necessary to remove all traces of microorganisms on or in the products, in particular by using so-called chemical sterilization or gas sterilization and / or wet antisepsis.

[0005] Thus, medical device manufacturers continually seek to provide effective sterilization systems for surgical instruments. Existing sterilization systems generally include containers for receiving surgical instruments to be sterilized, with openings for receiving sterilizing agents so that these can be pressurized and / or heated, so that the sterilizing agent(s) destroy the microorganisms present on said surgical instruments.

[0006] The containers can be placed in the sterilization device for periods of time which are determined empirically, including threshold treatment conditions guaranteeing a desired level of sterilization for the corresponding instruments.

[0007] In particular, the quantity of microorganisms on the instruments can be measured before and after a sterilization process, and if the sterilization process achieves a desired reduction in microorganisms on the instruments, the measured characteristics of this process can be empirically determined as the threshold conditions of the process guaranteeing the desired level of sterilization. Depending on the desired level of sterilization and the instruments For sterilization, time periods ranging from 0.1 to 48 hours can be empirically determined as threshold conditions of the process, or to measure the control of the sterilization process.

[0008] One disadvantage of these sterilization systems and the associated sterilization process is that instruments may not be properly disinfected to the desired level of sterilization, and that the failure to achieve the desired level of sterilization may not be immediately noticed by healthcare professionals.

[0009] In particular, the instruments inside the container may not be exposed to the sterilizing agent and therefore the instruments may not be exposed to the threshold treatment conditions determined empirically to disinfect these instruments to the desired level of sterilization, resulting in a lack of control of the sterilization process by this method.

[0010] There is therefore a need to provide a device for detecting and measuring the concentration of a precise sterilizing agent, in order to detect the presence and / or concentration of a sterilizing agent, particularly for continuous monitoring processes which require the ability to detect whether the sterilization process has been effective, in particular by measuring the concentration of the sterilizing agent in the determined sterilization zone.

[0011] Indeed, the systems for detecting and measuring the concentration of a sterilizing agent are not precise enough, which can lead to the validity of a non-compliant sterilization process, which can subsequently lead to health problems, in particular through the use of surgical instruments that are not sterilized, or at least not sufficiently sterilized.

[0012] The invention therefore falls within this context and seeks to meet all the aforementioned needs while resolving all the aforementioned drawbacks.

[0013] Thus, the invention seeks to provide a system for detecting and measuring the concentration of at least one sterilizing agent in gaseous state for a low temperature sterilizer that is simple to use, reliable, and also allows for very precise measurement of the concentration of the sterilizing agent or even of a smaller quantity of sterilizing agent in order to detect it.

[0014] Similarly, the invention proposes a low temperature sterilizer comprising said system for detecting and measuring the concentration of at least one sterilizing agent in the gaseous state, allowing for more effective and safer sterilization.

[0015] Presentation of the invention.

[0016] To this end, a system for detecting and measuring the concentration of at least one sterilizing agent in gaseous form has been developed for a low-temperature sterilizer comprising at least one electromagnetic radiation emitter with an emission frequency over a predetermined frequency range, at least one receiver of said electromagnetic radiation capable of targeting a predetermined electromagnetic radiation frequency of the emitter and capable of emitting a signal, at least one signal processing device of the receiver capable of detecting and / or measuring the concentration of at least one sterilizing agent as a function of its absorbance rate in the electromagnetic radiation frequency predetermined by the receiver, at least one sensor of a physical parameter, arranged so as to capture in an area located between the electromagnetic radiation emitter with an emission frequency over a predetermined frequency range and its receiver,said zone positioned between the emitter of electromagnetic radiation with an emission frequency within the predetermined frequency range and its receiver, defining a measurement zone and at least one control unit capable of modifying the target frequency of the electromagnetic radiation by the receiver.

[0017] According to the invention, the control unit is adapted to adjust the frequency of the electromagnetic radiation targeted by the receiver as a function of at least one physical parameter measured in the measurement area by the sensor.

[0018] It is understood, then, according to the invention, that the measurement of the concentration of a sterilizing agent is more precise. Similarly, the detection of said sterilizing agent can be carried out with a smaller quantity of sterilizing agent, which consequently allows for better control and greater assurance of the proper execution of a sterilization cycle using a gaseous sterilizing agent.

[0019] Indeed, during a sterilization cycle, many physical parameters in the measurement area, which is also the sterilization area, are modified which can alter the optimal absorbance wavelength of a given molecule, in this case a sterilizing agent.

[0020] Consequently, the operation of detecting and / or measuring the concentration of a sterilizing agent is approximate because the wavelength or emission frequency of the optimal absorption electromagnetic radiation can be modified during a sterilization cycle.

[0021] In a particular embodiment, the electromagnetic radiation emitter with emission frequency over a predetermined frequency range is a light source emitting in the infrared.

[0022] In a preferred embodiment, the receiver of said electromagnetic radiation capable of targeting a predetermined frequency of the electromagnetic radiation is a spectrometer, preferably a spectrophotometer.

[0023] In a particular embodiment, the detection system is arranged in a housing comprising, in a first compartment, an optical bench comprising the transmitter and receiver but also in a second compartment a power supply system, the signal processing device and the control unit.

[0024] In this embodiment, the power supply system includes a voltage amplifier and a regulating operational amplifier.

[0025] The term “sterilizing agent” means molecules whose uses are useful in a process of destroying microorganisms.

[0026] Preferably, the adjustment by the control unit of the radiation frequency targeted by the receiver is carried out by measuring the absorbance rate of radiation frequencies close to that of the predetermined target frequency, and by comparing the measured absorbance rates in order to determine the highest absorbance rate.

[0027] Thus, it is understood that the control unit can adjust the radiation frequency, or the wavelength of the receiver so that the latter can target the frequency in which the absorbance rate is highest depending on the modification of this wavelength due to the modification of the physical parameters in the measurement area.

[0028] It is thus understood that the control unit empirically tests all frequencies close to the predetermined one and continues to shift the radiation frequency targeted by the receiver as long as the abort rate is higher in a close frequency than in the targeted one.

[0029] Therefore, when the target radiation frequency is higher than neighboring radiation frequencies, the control unit maintains this target radiation frequency for the receiver.

[0030] The electromagnetic radiation frequency comparisons are carried out at every nanometer, preferably at every 0.5 nanometer, preferably at every 0.25 nanometer, preferably at every 0.1 nanometer and even more preferably at every 0.01 nanometer.

[0031] In a preferred embodiment, the emitter comprises at least one broadband light source, said broadband light source emitting in a predetermined frequency range between 1400 nm and 1520 nm.

[0032] Preferably, the emitter includes at least one light source capable of emitting pulsed or continuous light.

[0033] Advantageously, the control unit is adapted to adjust the emission frequency of electromagnetic radiation according to the pressure measured in the measurement area.

[0034] In another embodiment, the control unit is adapted to adjust the emission frequency of electromagnetic radiation according to the temperature measured in the measurement area.

[0035] In a preferred embodiment, the control unit is adapted to adjust the emission frequency of electromagnetic radiation as a function of at least two physical parameters measured in the measurement area.

[0036] Preferably, the control unit is adapted to adjust the emission frequency of electromagnetic radiation according to the pressure and / or temperature measured in the measurement area.

[0037] It is thus understood that the system in this embodiment can include at least two sensors to respectively measure two distinct physical parameters.

[0038] In a particular embodiment, the sensor is capable of measuring at least two physical parameters in the measurement area.

[0039] Advantageously, the signal processing device includes a calculation unit adapted to calculate the mole fraction of at least one sterilizing agent.

[0040] In a preferred embodiment, the calculation unit of the signal processing device is adapted to calculate the condensation rate in the measurement area.

[0041] It is understood that during a sterilization cycle, there is a mixture of sterilizing agent molecules in both liquid and gaseous states. The system according to the invention is adapted to detect and measure the concentration of at least one sterilizing agent in the gaseous state but can also measure the condensation rate. Indeed, by measuring the absorbance rate of a sterilizing agent at a predetermined frequency and its condensation rate, the system can calculate the fraction of the physical state of the sterilizing agent molecules.

[0042] Preferably, the calculation unit is capable of calculating the residue rate of the sterilizing agent during a sterilization cycle.

[0043] In a preferred embodiment, the system for detecting and / or measuring the concentration of at least one sterilizing agent in the gaseous state for a low temperature sterilizer detects and measures the concentration of at least two sterilizing agents.

[0044] Preferably, said two sterilizing agents are hydrogen peroxide and water.

[0045] In a particular embodiment, the receiver is capable of targeting at least two frequencies in the predetermined frequency range of the electromagnetic radiation emitted by the transmitter, said at least two frequencies extending respectively between 1400 nm and 1450 nm and between 1450 nm and 1520 nm.

[0046] The invention also relates to a low temperature sterilizer comprising the system for detecting and measuring the concentration of at least one sterilizing agent according to the invention.

[0047] It is then understood that the system for detecting and measuring the concentration of a sterilizing agent is arranged to detect and measure the concentration of at least a sterilizing agent in a compartment intended to receive items to be sterilized, such as surgical instruments.

[0048] Other advantages and features of the present invention are now described by means of purely illustrative and in no way limiting examples of the scope of the invention, and from the accompanying drawings, in which the various figures represent:

[0049] [Fig. 1] is a schematic representation of the system for detecting and measuring the concentration of at least one sterilizing agent in the gaseous state according to the invention.

[0050] [Fig.2] is a schematic representation of the system for detecting and measuring the concentration of at least one sterilizing agent in the gaseous state, according to a particular embodiment.

[0051] [Fig.3] is a schematic representation of the system for detecting and measuring the concentration of at least one sterilizing agent in the gaseous state integrated into a low temperature sterilizer.

[0052] For reasons of simplicity and clarity of illustration, the elements shown in the figures have not necessarily been drawn to scale. Thus, the dimensions and relative proportions of certain elements may be exaggerated or reduced.

[0053] In the following description, identical elements, by structure or by function, appearing on different figures retain, unless otherwise specified, the same references.

[0054] It should be noted that in these figures the structural and / or functional elements common to the different variants may have the same references.

[0055] Of course, various other modifications can be made to the invention within the scope of the annexed claims.

[0056] With reference to [Fig.1], the invention relates to a system 1 for detecting and measuring the concentration of two sterilizing agents 2 in the gaseous state for a low temperature sterilizer.

[0057] The system 1 comprises an electromagnetic radiation emitter 3 with emission frequency over a predetermined frequency range between 1400 nm and 1520 nm, said emitter comprising a broadband light source 31, said broadband light source 31 emitting over a predetermined frequency range between 1400 nm and 1520 nm.

[0058] In order to detect and / or measure the concentration of the two sterilizing agents 2 more precisely, the receiver 4 is capable of targeting at least two frequencies within the predetermined frequency range of the electromagnetic radiation emitted by the emitter 3, said at least two frequencies extending respectively between 1400 nm and 1450 nm and between 1450 nm and 1520 nm, which are the wavelengths in which the two sterilizing agents 2, namely hydrogen peroxide and water, have an optimum absorbance rate.

[0059] The system 1 also includes a receiver 4 of said electromagnetic radiation capable of targeting a predetermined frequency of the electromagnetic radiation and capable of emitting a signal.

[0060] Once the radiation is received, the receiver 4 emits a signal which is received by a signal processing device 5, said signal processing device 5 is capable of detecting and / or measuring the concentration of at least one sterilizing agent 2 as a function of its absorbance rate in the frequency of the electromagnetic radiation targeted in a predetermined manner by the receiver 4.

[0061] In order to achieve a finer detection and / or measurement of the concentration of the two sterilizing agents 2, the system 1 also includes a sensor 6 arranged to capture in an area located between the emitter 3 of electromagnetic radiation with emission frequency on a predetermined frequency range and its receiver 4, said area positioned between the emitter 3 of electromagnetic radiation with emission frequency on the predetermined frequency range and its receiver 4 defining a measurement area 7.

[0062] Finally, and still with the aim of improving the accuracy of detection and / or measurement of the concentration of the two sterilizing agents 2, the system 1 includes a control unit 8 capable of modifying the target frequency of the electromagnetic radiation by the receiver 4 as a function of the pressure and / or temperature measured in the measurement area 7.

[0063] In order to efficiently adjust the target frequency of the electromagnetic radiation by the receiver 4, the control unit 8 will compare the absorbance rate of the two sterilizing agents 2 with the frequencies close to those targeted by the receiver 4 and retain the one with the highest absorbance rate for the two sterilizing agents 2 until the frequency at which their absorbance rate is highest is obtained for each of the two sterilizing agents 2.

[0064] This comparison is carried out by the control unit 8 by modifying the frequency targeted by the receiver 4 starting from the predetermined frequency and adding and subtracting 0.1 nanometers, in order to sweep through all the neighboring frequencies.

[0065] Furthermore, and in order to add functions to the system 1 for detecting and measuring the concentration of the two sterilizing agents 2, the signal processing device 5 includes a calculation unit 51 capable of calculating the mole fraction of the two sterilizing agents 2 in the gaseous state.

[0066] As illustrated in [Fig. 2], the system 1 is arranged in a housing 10 comprising, in a first compartment 11, an optical bench including the transmitter 3 and the receiver 4, said housing 10 also comprising, in a second compartment 12, a power supply system 13, the signal processing device 5 and the control unit 8.

[0067] As for [Fig.3], the latter illustrates a low temperature sterilizer 9 comprising the system 1 according to the invention.

[0068] Thus, the measuring zone 7 is the sterilization compartment in which the items to be sterilized, preferably surgical instruments, are placed.

[0069] In any event, the invention cannot be limited to the embodiments specifically described in this document, and extends in particular to all equivalent means and to any technically operative combination of these means.

Claims

1.

2. Demands System (1) for detecting and measuring the concentration of at least one sterilizing agent (2) in the gaseous state for a low-temperature sterilizer (9) comprising: - At least one emitter (3) of electromagnetic radiation with emission frequency over a predetermined frequency range; - At least one receiver (4) of said electromagnetic radiation capable of targeting a predetermined frequency of the electromagnetic radiation of the emitter (3) and capable of emitting a signal; - At least one signal processing device (5) of the receiver (4) capable of detecting and / or measuring the concentration of at least one sterilizing agent (2) as a function of its absorbance rate in the frequency of electromagnetic radiation predetermined by the receiver (4); - At least one sensor (6) of a physical parameter, arranged so as to capture in an area located between the emitter (3) of electromagnetic radiation with an emission frequency over a predetermined frequency range and its receiver (4), said area positioned between the emitter (3) of electromagnetic radiation with an emission frequency over the predetermined frequency range and its receiver (4) defining a measurement area (7); and - At least one control unit (8) capable of modifying the target frequency of the electromagnetic radiation by the receiver (4), Characterized in that the control unit (8) is adapted to adjust the frequency of the electromagnetic radiation targeted by the receiver (4) as a function of at least one physical parameter measured in the measurement area (7) by the sensor (6). System (1) according to the preceding claim, characterized in that the adjustment by the control unit (8) of the radiation frequency targeted by the receiver (4) is carried out by measuring the absorbance rate of radiation frequencies close to that of the predetermined target frequency, and by comparing the rates absorbance measurements were taken to determine the highest absorbance rate.

3. System (1) according to any one of the preceding claims, characterized in that the emitter (3) comprises at least one broadband light source (31), said broadband light source (31) emitting in a predetermined frequency range between 1400 nm and 1520 nm.

4. System (1) according to any one of the preceding claims, characterized in that the control unit (8) is adapted to adjust the emission frequency of electromagnetic radiation as a function of the pressure measured in the measurement area (7).

5. System (1) according to any one of claims 1 to 3, characterized in that the control unit (8) is adapted to adjust the emission frequency of electromagnetic radiation as a function of the temperature measured in the measurement area (7).

6. System (1) according to any one of the preceding claims, characterized in that the control unit (8) is adapted to adjust the emission frequency of electromagnetic radiation as a function of at least two physical parameters measured in the measurement area (7).

7. System (1) according to any one of the preceding claims, characterized in that the signal processing device (5) comprises a calculation unit (51) adapted to calculate the mole fraction of at least one sterilizing agent (2).

8. System (1) according to any one of the preceding claims, characterized in that it detects and / or measures the concentration of at least two sterilizing agents (2).

9. System (1) according to the preceding claim, characterized in that the receiver (4) is capable of targeting at least two frequencies within the predetermined frequency range of the electromagnetic radiation emitted by the transmitter (3), said at least two frequencies extending respectively between 1400 nm and 1450 nm and between 1450 nm and 1520 nm

10. 11111. Low temperature sterilizer (9) comprising the system (1) for detecting and measuring the concentration of at least one sterilizing agent (2) according to any one of claims 1 to 9.

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