Hydrogen therapy device and system

Abstract

A hydrogen therapy device comprising an electrolysis system including an arrangement of implantable electrodes, an electric generator, and a control system configured to place the electrolysis system in a production state to perform electrolysis of a bodily fluid according to a plurality of application parameters to produce hydrogen, wherein at least one of the application parameters is adjustable and the control system is configured to measure a production parameter representative of the hydrogen produced, and to modulate the adjustable application parameter of the electrolysis system as a function of the production parameter in order to deliver a quantity of hydrogen.

Description

Description Title: Hydrogen Therapy Device and System FIELD OF INVENTION

[0001] The present invention relates to a device and a hydrogen therapy system for delivering a quantity of hydrogen in situ by electrolysis of a body fluid. STATE OF THE ART

[0002] Shigeao Ohta (Pharmacology & Therapeutics 144, 2014, 1-11) describes the medical benefits of hydrogen therapy, also called molecular hydrogen or therapeutic hydrogen. Hydrogen therapy consists of administering hydrogen in the form of dihydrogen (H2).

[0003] The use of hydrogen for therapeutic or physiological purposes is known through various delivery methods, such as gas inhalation, oral ingestion of water or saline solutions containing dissolved hydrogen, or incorporation by diffusion from eye drops, baths, and cosmetics. These methods are currently unsatisfactory because they are either too uncomfortable for the patient or limited in terms of the quantity that can be administered.

[0004] These methods all share the drawback of delivering hydrogen in an uncontrolled manner. Indeed, current state-of-the-art solutions do not allow for precise control of the delivery and maintenance of a therapeutic hydrogen concentration in the patient's body. Hydrogen administration is therefore uncertain and imprecise due to the significant variability in dihydrogen concentration.

[0005] The invention aims to provide a solution to the aforementioned problems. SUMMARY

[0006] According to a first aspect, the invention relates to a hydrogen therapy device for delivering a quantity of hydrogen in situ by electrolysis of a bodily fluid, the hydrogen therapy device comprising: - an electrolysis system configured to perform electrolysis of body fluid, the electrolysis system comprising: an electrode arrangement including at least two implantable electrodes, the electrode arrangement being configured to apply electric current to the body fluid, and an electric generator configured to apply electric current between the electrodes, - a control system configured to put the electrolysis system into a production state in which said electrolysis system performs the electrolysis of body fluid according to a plurality of electrical current application parameters adapted to produce hydrogen, in which at least one of the application parameters is modulable and the control system is configured to measure a production parameter representative of the hydrogen produced, and to modulate the modulable application parameter of the electrolysis system according to the production parameter to deliver the quantity of hydrogen.

[0007] Thus, the present invention proposes an implantable device comprising an electrolysis system that ensures the reliable delivery of a specific quantity of hydrogen over time, along with associated control and monitoring means. In particular, the hydrogen therapy device offers improved administration compared to state-of-the-art techniques by ensuring the production of the required quantity of hydrogen through the modulation of at least one parameter of the electrical current application based on the measurement of a production parameter.The modulation of the electrical current application parameters is based on measurements of the production parameter by the control system. This allows for maintaining the production of a quantity of hydrogen adapted to a patient's therapy, taking into account inter-individual variations, the patient's body environment and physiological state, the aging of the electrolysis system, and its level of fouling. Advantageously, modulating an electrical current application parameter based on a production parameter enables feedback control of hydrogen production, personalizing and adapting production according to the patient's needs, their bodily condition, and variations in the composition of the interstitial fluid.

[0008] The electrode arrangement can have a modular electrolysis surface area, with the application parameters encompassing the electrolysis surface area of ​​the electrode arrangement. Modulating the electrolysis surface area allows for control of the hydrogen production quantity by directly influencing the production parameter. Surface modulation notably enables the generation of a higher hydrogen production rate. Advantageously, modulating the electrolysis surface area allows for greater modularity of the hydrogen therapy device from a single standardized design. Therefore, modulating the electrolysis surface area eliminates the need to redesign a device of a different size depending on hydrogen production requirements.

[0009] The control system can be configured to modulate the duration of the production state; the application parameter includes the duration of the production state. Controlling the duration of the production state allows for modulation of the amount of hydrogen produced. Modulating the duration of the production state makes it possible, for example, to generate a lower average production rate at the same voltage.

[0010] The electric generator can be configured to apply an electric current with a modulating voltage, the application parameter being the generator's voltage. Voltage modulation allows control over the amount of hydrogen produced by adjusting the current flowing between the electrodes. By modulating the voltage, it is possible to generate an electric current that avoids the production of toxic metabolites, such as chlorine, resulting from uncontrolled electrolysis. Voltage modulation also allows for more precise control of hydrogen production by adapting to changes in the patient's physiological parameters, which can induce significant variability.Voltage modulation offers a more precise control alternative than practices observed in industrial systems where the control system applies a predefined voltage value much higher than the voltage measured across the electrolysis cell in order to ensure constant hydrogen production regardless of the state of the electrolysis medium.

[0011] The control system can be configured to control the electrolysis system in such a way as to produce the quantity of hydrogen over a treatment time comprising at least one operating cycle, the operating cycle comprising an active period during which the electrolysis system is in production mode, and a pause period during which the electrolysis system is not in production mode. A treatment duration determines the length of time the patient receives the specified amount of hydrogen. Organizing the treatment duration into operating cycles allows for the maintenance of a target body hydrogen concentration and ensures consistent absorption of the hydrogen produced. Organizing the treatment duration into operating cycles that include pause periods also allows the hydrogen therapy device to be taken offline for maintenance without affecting the patient's treatment.

[0012] The control system can be configured to control the electrolysis system according to at least two operating cycles, alternating between active and pause periods. This alternation allows the application parameters of the electrolysis system to be modulated based on the hydrogen production parameter measured during the previous active period. Thus, the hydrogen production level during the first operating cycle can be used to adjust the application parameters of the electrolysis system during the subsequent operating cycle. Furthermore, the pause periods between two active periods can be used to perform maintenance without affecting patient treatment.

[0013] The control system is configured to put the electrolysis system into a regeneration state separate from the production state. In this regeneration state, the electrolysis system is configured to clean the electrodes. The electrode regeneration state can occur during a pause period. Electrode cleaning is a maintenance operation for the hydrogen therapy device, ensuring the long-term performance of the electrodes. It guarantees the proper functioning of the hydrogen therapy device by preventing electrode contamination and fouling. It also ensures proper operation by preventing the production of harmful secondary metabolites that can reduce electrode performance by altering their impedance. Electrode fouling can lead to the synthesis of harmful byproducts for the patient.

[0014] The control system can be configured to put the electrolysis system into regeneration mode when a target production parameter is not met within a specified time window. The inability to produce the required amount of hydrogen within the treatment duration or operating cycle time window triggers the regeneration system to restore proper operation of the hydrogen therapy device.

[0015] The control system can be configured to modulate the application parameter of the electrical current within an operating range between two terminals, and to put the electrolysis system into a regeneration state when said electrolysis system has remained in a production state with the application parameter near one of the terminals for a critical duration. The regeneration state is activated as a consequence of prolonged operation within extreme operating ranges, associated with suboptimal operation of the hydrogen therapy device.

[0016] The control system can be configured to reverse one electrode polarity during the electrolysis system's regeneration phase. Reversing the electrode polarity reverses the direction of electric current flow and helps clean the electrodes by preventing the accumulation of charged impurities on one electrode. This polarity reversal prevents changes in electrode impedance and ensures long-term electrode performance.

[0017] The control system can be configured to, in the production state, apply the electric current with an electrolysis voltage within an electrolysis range and, in the regeneration state of the electrolysis system, apply an electric current pulse with a regeneration voltage outside the electrolysis range.

[0018] Applying an electrical current pulse with a regeneration voltage outside the electrolysis range dislodges impurities from the electrodes, thus ensuring their long-term performance. Advantageously, applying a pulse allows for rapid action without disrupting the device's operation or impacting the patient.

[0019] The control system can be configured to perform a calibration phase of the electrolysis system to define initial values ​​for the application parameters. The control system begins an initial operating cycle associated with the production of a quantity of hydrogen based on initial application parameter values ​​corresponding to theoretical values ​​for producing the target quantity of hydrogen. During the calibration phase, the control system measures the production parameter and modulates the application parameters around these initial values ​​to ensure the production of the target quantity of hydrogen.

[0020] The electric current can have a specific intensity, and the production parameter can be the intensity of the electric current. The current intensity established within the electrode arrangement can vary for a given current voltage because the impedance of the electrical circuit, and more specifically of the electrodes, is directly affected by variations in the composition of the body fluid, as well as by electrode wear due to repeated use of the hydrogen therapy device. Measuring the current intensity is representative of the electrolysis of the body fluid and thus allows for the determination of the rate of hydrogen production and ensures the production of a target quantity of hydrogen at a target intensity.

[0021] The control system may include a communication interface configured to communicate with an external operator. The hydrogen therapy device is configured to send data related to its operation to a human or machine operator. The hydrogen therapy device is also configured to receive information related to its operation.

[0022] The electrolysis system also includes an implantable unit and a battery electrically connected to the power generator. The power generator and battery are housed within the implantable unit, and the battery is remotely rechargeable via an external charger. The rechargeable battery ensures autonomous hydrogen production and patient independence from the external charger.

[0023] According to a second aspect, the invention relates to a hydrogen therapy system comprising a hydrogen therapy device and an external charger configured to remotely recharge the battery. The battery is recharged by an external charger in order to reduce its size and ensure the miniaturization of the electrolysis system.

[0024] This disclosure also describes a hydrogen therapy method for delivering a quantity of hydrogen in situ by electrolysis of a bodily fluid, the method hydrogen therapy implementing the hydrogen therapy device and comprising steps consisting of: - in a production state of an electrolysis system, perform electrolysis of body fluid according to a plurality of electrical current application parameters adapted to produce hydrogen, at least one of the application parameters being adjustable, - to measure a production parameter representative of the hydrogen produced, and - modulate the adjustable application parameters according to the production parameter to deliver the quantity of hydrogen.

[0025] Under specific provisions, the disclosure also relates to a hydrogen therapy device for delivering a quantity of hydrogen in situ by electrolysis of a bodily fluid, the hydrogen therapy device comprising: - an electrolysis system configured to perform electrolysis of body fluid, the electrolysis system comprising: an electrode arrangement including at least two implantable electrodes, the electrode arrangement being configured to apply electric current to the body fluid, each electrode having an electrode surface and the electrode arrangement having a tunable electrolysis surface consisting of the electrode surfaces of at least two electrodes, and an electrical generator configured to apply electric current between the electrodes, - a control system configured to put the electrolysis system into a production state in which said electrolysis system performs electrolysis of body fluid to produce hydrogen, in which the control system is configured to measure a production parameter representative of the hydrogen produced, and to modulate the electrolysis surface of the electrode arrangement as a function of the production parameter to deliver the quantity of hydrogen.

[0026] At least one of the electrodes in the electrode arrangement can have a modulable electrode surface, and the control system can be configured to modulate the electrolysis surface of the electrode arrangement according to the production parameter.

[0027] The electrode arrangement may include a plurality of electrode pairs, each configured to apply electric current, and the control system is configured to modulate a number of electrode pairs according to the production parameter.

[0028] At least two of the electrodes in the electrode arrangement may have equal electrode surfaces.

[0029] At least two of the electrodes in the electrode arrangement may have different electrode surfaces.

[0030] Under specific provisions, the disclosure also relates to a hydrogen therapy device for delivering a quantity of hydrogen in situ by electrolysis of a bodily fluid, the hydrogen therapy device comprising: - an electrolysis system configured to perform electrolysis of body fluid, the electrolysis system comprising: an electrode arrangement including at least two implantable electrodes, the electrode arrangement being configured to apply electric current to the body fluid, and an electric generator configured to apply electric current between the electrodes, - a control system configured to put the electrolysis system into a production state in which said electrolysis system performs electrolysis of body fluid to produce hydrogen, in which the control system is configured to measure a production parameter representative of the hydrogen produced, and to control the electric generator according to the production parameter to deliver the quantity of hydrogen.

[0031] The electric generator can be configured to apply electric current with a modulating voltage, and the control system is configured to modulate the voltage of the electric generator according to the production parameter.

[0032] The control system can be configured to modulate the voltage of the electric generator within an electrolysis range during the production state of the electrolysis system. BRIEF DESCRIPTION OF THE FIGURES

[0033] Other objects and advantages of the invention will become apparent from the following detailed description of a particular embodiment, given by way of non-limiting example, in relation to the accompanying drawings in which:

[0034] - Figure 1 represents a hydrogen therapy device according to an embodiment of the invention placed on a patient, the hydrogen therapy device being configured to produce hydrogen from the electrolysis of a bodily fluid,

[0035] - Figure 2 represents an exploded view of the hydrogen therapy device of Figure 1, the hydrogen therapy device comprising an implantable housing configured to perform electrolysis of body fluid and comprising at least one electrode arrangement of the electrolysis system, external equipment configured to integrate externalizable functions in order to reduce the size of the implantable part, and a means of fixing the external equipment in correspondence with the implantable housing,

[0036] - Figure 3 schematically illustrates the hydrogen therapy device as shown in Figure 1 and Figure 2, comprising a control system configured to measure a production parameter representative of the hydrogen produced by the electrolysis system, the control system being configured to modulate application parameters so as to apply feedback control to the electrolysis system comprising the electrode arrangement and the electrical generator,

[0037] - Figure 4 describes the relationship between hydrogen production and the value of an application parameter affected by the variation in electrode impedance; an application parameter value enabling a target value of the production parameter to be reached is associated with a production parameter value measured by the control system in Figure 3; Figure 4 also illustrates an operating range in which it is possible to modulate the application parameter.

[0038] - Figure 5 represents a particular operating mode of Figure 3 in which the modulated application parameter for hydrogen production can be the voltage of the electric generator or the duration of application of the electric current; the control system then modulates the application parameter at the level of the electric generator of the electrolysis system.

[0039] Figures 6A and 6B represent control modes of the electrolysis system based on modulation of the duration of electric current application by the control system. The control system modulates the duration of the production state to achieve the target quantity of hydrogen (Qc), also known as the theoretical quantity (Qt). Figure 6A represents a situation where the measured value of the production parameter is greater than the target value, which allows the duration of the production state to be reduced to deliver the target quantity of hydrogen, as the actual quantity (Qr) of hydrogen produced reaches the target quantity sooner. Conversely, Figure 6B represents a situation where the measured value of the production parameter is less than the target value, which requires extending the duration of the production state to deliver an actual quantity (Qr) of hydrogen according to the target quantity of hydrogen (Qc).

[0040] - Figures 7A and 7B represent a succession of operating cycles of the electrolysis system controlled by the control system, each operating cycle comprising an active stage and a pause stage; Figure 7A represents a control mode in which each operating cycle periodically delivers a fixed quantity of hydrogen; Figure 7B represents a control mode involving an alternation of operating cycles of the electrolysis system, each operating cycle periodically delivering an intermediate quantity of hydrogen, the control system modulating the duration of the production states within each operating cycle in order to ensure the production of the target quantity of hydrogen during the treatment period.

[0041] - Figures 8A, 8B and 8C represent the hydrogen therapy device as described in Figure 1, whose modulated application parameter for hydrogen production can be the electrolysis surface; Figure 8A concerns an electrolysis surface composed of electrodes of identical size; Figure 8B concerns an electrolysis surface composed of electrodes comprising at least two different sizes; Figure 8C illustrates a scheme of use in several operating cycles of an electrode surface allowing alternating the electrodes maintained in pause period for the same given electrolysis surface.

[0042] - Figure 9 describes a method for achieving a regeneration state of the electrolysis system to clean the electrodes,

[0043] - Figure 10 represents an example of a method for implementing the hydrogen therapy device described between Figures 1 to 9 in which the production parameter is modulated according to an application parameter including, for example, voltage, duration of the production state, electrolysis surface or a combination of at least one of these parameters. DETAILED DESCRIPTION

[0044] The present invention relates to a hydrogen therapy device (1) for delivering a quantity of hydrogen in situ by electrolysis of a body fluid, such as interstitial fluid.

[0045] The hydrogen therapy device as shown in Figures 1 and 2 comprises an implantable unit (40) for producing hydrogen and a non-implantable external component (20). Advantageously, an intermediate fixation means allows the non-implantable external component to be positioned on the patient's skin opposite the implantable component. Advantageously, the implantable component is a subclavicular implant.

[0046] The hydrogen therapy device (1) as shown in Figure 1 and Figure 2 comprises an electrolysis system (2) configured to perform electrolysis of the body fluid placed in the implantable device (40). The electrolysis system (2) includes an electrode arrangement (3) of at least two electrodes (4) configured to apply an electric current to the body fluid, and an electric generator (5) configured to apply the electric current between the electrodes (4). The electric current applied between the electrodes (4) can be characterized by its intensity. The electric generator (5) is powered by a power source.

[0047] The power source for the electric generator (5) can be an external battery, contained within the non-implantable external device (20), supplying the necessary power to the electric generator (5) via remote power supply when it is positioned opposite the electrolysis system (2) on the patient's body. The non-implantable external device (20) can be positioned using the intermediate fixation means (30). The electrolysis system (2) is in this passive configuration and does not produce hydrogen in the absence of external non-implantable equipment (20).

[0048] Alternatively, the electrical power source for the electric generator (5) can be a rechargeable battery electrically connected to the electric generator (5) and housed in the implantable device (40). In this embodiment, the battery is periodically recharged via wireless power supply using the external non-implantable device (20) as an external charger. It should be noted that wireless power supply is a means of wireless energy transfer, which may be inductive charging. Alternatively, the connection between the implantable device (40) and the external non-implantable device (20) can be physical, via a wired connection with an interface for connecting to the implantable device (40) that remains accessible after implantation.In this configuration where the electrolysis system (2) includes a rechargeable battery, the electrolysis system (2) is said to be active and can be in a production state in the absence of the external non-implantable equipment (20) for a period equivalent to the autonomy of the rechargeable battery.

[0049] Although described in connection with a hydrogen therapy device (1) comprising an implantable unit (40) and external non-implantable equipment (20), the invention is not limited to this. In other embodiments, the hydrogen therapy device may be energy self-powered, thus not requiring external non-implantable equipment (20). In another embodiment, the hydrogen therapy device (1) may dispense with the implantable unit (40), with only the electrodes being implantable, for example.

[0050] The hydrogen therapy device includes a control system (6) configured to put the electrolysis system (2) into a production state to perform the electrolysis of the body fluid to produce hydrogen. The control system (6) may include a microcontroller (MCU) and dedicated control software enabling the control of the electrolysis system (2) according to at least one application parameter (7). In the production state, electrolysis is performed according to one or more application parameters (7) of the electric current, at least one of which is adjustable based on a production parameter (8) measured by the control system (6). The production parameter (8) is representative of the hydrogen produced. Depending on the quantity of hydrogen to be produced for the delivery of a treatment, called the target quantity of hydrogen, there is a target value of the production parameter (8) for which one or more application parameters (7) can be modulated so as to achieve the target quantity of hydrogen to be produced for the delivery of a treatment.

[0051] The production parameter (8) determines the quantity of hydrogen produced. In one embodiment, the production parameter (8) can be based on the current intensity. For each current intensity value, there is a corresponding rate of hydrogen production. This relationship derives from Faraday's first law, which describes the proportional relationship between the amount of substance released during electrolysis at an electrode and the application of an electric current for a specified duration. Measuring the production parameter (8) using the control system (6) allows the quantity of hydrogen actually produced to be determined. The control system (6) may include means for measuring the current intensity, for example, a shunt resistor.The control system (6) may include means for measuring the current intensity and / or a current-sensing amplifier for generating a voltage proportional to the current flowing in the circuit, in order to convert it into a measurable voltage current. The control system (6) thus enables the production of the quantity of hydrogen to be controlled according to a target value of the production parameter (8). The control system (6) measures the production parameter (8) based on the current intensity established between the electrodes and modulates one or more of the application parameters (7) so as to achieve the target value of the production parameter (8) enabling the production of the required target quantity of hydrogen.

[0052] The quantity of hydrogen can correspond to a prescribed hydrogen dose. In a particular application, the dose may be daily and correspond to the amount of hydrogen to be produced over a 24-hour period. Depending on the target dosage, it is possible to plan for several intermediate doses or quantities to deliver the daily dose of hydrogen. In other words, a quantity of hydrogen can be obtained by producing several intermediate quantities. It is also possible to plan for the delivery of several doses of hydrogen in a single day or over a 24-hour period.

[0053] The control system (6) can modulate the application parameter (7) of the electric current within an operating range (9), delimited by a minimum limit (9a) and a maximum limit (9b). Figure 4 shows that there exists, for a The target value of the production parameter (8) is determined by the application parameter (7), which varies according to the electrode impedance and electrolysis conditions. The control system (6) allows modulation of the application parameter (7) to position the electrolysis system (2) under conditions that enable it to achieve the target value of the production parameter (8).

[0054] In a first embodiment shown in Figure 5, the application parameter (7) modulated by the control system (6) is the voltage (7a) of the electrical generator (5). The voltage (7a) is preferably modulated within an operating range (9) between 0.6V and 1.3V. This operating range (9), where the current application parameter (7) is the voltage (7a), is called the electrolysis range. A voltage (7a) whose value falls within the electrolysis range is an electrolysis voltage. It is within this operating range (9) that the electrolysis of the body fluid occurs while limiting the production of compounds harmful to the patient, such as chloride. The electrolysis range can be between 0.1V and 1.3V. For alternating modes, the electrolysis range can be between 0.6V and 1.3V. It is within the electrolysis range that the electrolysis voltage (7a) to be applied to produce the quantity of hydrogen is determined.In other words, it is during the application of an electrolysis voltage that the quantity of hydrogen is produced and measured by the control system (6). Any hydrogen production resulting from the application of a voltage with a value outside the electrolysis range can be neglected by the control system (6).

[0055] In a second embodiment, the application parameter (7) modulated by the control system (6) is the duration of the production state (7b), also referred to hereafter as the duration of application of the electric current (7b) by the electric generator (5) or the duration of the production state. Depending on the measured value of the production parameter (8), the control system adjusts the duration of the production state (7b). In this embodiment, the control system (6) allows the duration of the production state to be controlled according to data pre-programmed at the microcontroller level of the control system. The control software includes at least one communication protocol allowing the microcontroller data to be updated according to the production parameter (8) or according to external updates instructed by the patient or a practitioner. Figures 6A and 6B illustrate scenarios where a quantity of hydrogen is produced in a single production state, where the current intensity established between the electrodes (4) corresponds to a production rate. The area represented by the zone delimited between the duration of the target production state and the target value of the production parameter (8) corresponds to the target quantity of hydrogen to be produced. The area represented by the zone delimited between the duration of the measured production state and the measured value of the production parameter (8) corresponds to the quantity of hydrogen produced, according to the application parameter (7). In this embodiment, the control system (6) modulates the duration of application of the electric current (7b), or duration of the production state, so that the quantity of hydrogen produced is equal to the target quantity of hydrogen to be produced.

[0056] Figure 6A illustrates the case where an increase in electrolysis time, that is, the duration for which the electrolysis system (2) is in the production state, compensates for a decrease in the production rate due to an increase in electrode impedance or a change in the body fluid impedance, in order to produce the desired quantity of hydrogen or dose. The actual duration of the production state required to produce the quantity of hydrogen is therefore greater than the theoretical duration of the production state.

[0057] Figure 6B illustrates the case where a decrease in electrolysis time compensates for an excessively high production rate due to a decrease in electrode impedance or a change in body fluid impedance, thus producing the desired amount of hydrogen or dose. The duration of the production state required to produce the target amount of hydrogen is therefore shorter than the theoretical duration of the production state. This production state duration can be defined within an operating range (9) between a minimum (9a) and a maximum (9a) duration determined according to the target amount of hydrogen to be produced and the desired blood hydrogen concentration.

[0058] The control system (6) can be configured to control the electrolysis system (2) to produce the quantity of hydrogen over a treatment period comprising one or more operating cycles (10). Each operating cycle (10) includes an active period (11) in which the electrolysis system (2) is in production, and a pause period (12) in which the electrolysis system (2) is not in production. For a treatment On a daily basis, an operating cycle (10) does not exceed 24 hours; in other words, it is possible for only one dose, or one quantity of hydrogen, to be delivered in a single operating cycle (10) over a 24-hour period. This scenario corresponds to a quantity of hydrogen delivered for one day, which can be delivered in a single active period (11). The operating cycle (10) ends with a pause period (12) between the end of the production state (11) and the beginning of the next operating cycle (10). For example, it is possible to deliver a quantity of hydrogen in a single 24-hour operating cycle (10) comprising an active period (11) of 8 hours and a pause period (12) of 16 hours. A second example may be the delivery of a quantity of hydrogen over a single operating cycle (10) of 24h comprising an active period of (11) of 23h and a pause period (12) of Ih.

[0059] In Figure 7A, several operating cycles (10) enable hydrogen production such that active periods (11) and rest periods (12) alternate. This embodiment makes it possible to deliver several quantities of hydrogen, or several doses, each in a single operating cycle (10) at different times of the day. This production method avoids continuous operation of the hydrogen therapy device, which would involve high energy consumption. The quantity of hydrogen produced is sufficient to maintain a blood hydrogen concentration that meets the treatment requirements while awaiting the production of the next quantity of hydrogen.

[0060] In Figure 7B, the quantity of hydrogen is delivered in at least five operating cycles (10). The sum of intermediate quantities produced Q1, Q2, Q3, Q4, and Q5 yields a dose or quantity of hydrogen according to the target value of the production parameter (8). In this embodiment, the control system (6) manages hydrogen production by taking into account the target value of the production parameter (8) and data related to hydrogen production during the preceding operating cycles (10). Thus, the control system (6) modulates the application parameter (7) to achieve the target quantity of hydrogen to be produced. As an example, Figure 7B shows a configuration where the hydrogen production rate decreases and requires adjusting the duration of the active and pause periods within the different operating cycles (10). By reducing the pause periods P3, P4, and P5 relative to P1 and P2 the control system (6) manages to ensure the production of the target quantity of hydrogen by increasing the duration of the production state obtained during the active period of the corresponding operating cycles (10).

[0061] In a third embodiment, the application parameter (7) modulated by the control system (6) is the electrolysis surface (7c) of the electrode arrangement (3). The electrolysis surface (7c) can be defined as the surface of the electrode arrangement (3) in contact with the body fluid and enabling the production of hydrogen by electrolysis of the body fluid. The amount of hydrogen produced will therefore be modulated according to the sum of the current intensities established between different pairs of electrodes (4). Figure 8A illustrates an electrode arrangement (3) that may include several electrodes (4) of identical sizes defining a modulating electrolysis surface (7c). Each pair of electrodes (4) then represents an electrolysis module enabling the production of hydrogen, each pair of electrodes (4) having an identical hydrogen production capacity.

[0062] Figure 8B illustrates an electrode arrangement (3) that can include several electrodes (4) of different sizes. More specifically, the electrode arrangement (3) can include at least two different electrode sizes. Each pair of electrodes (4) then represents an electrolysis module for hydrogen production, with each pair of electrodes (4) having a hydrogen production capacity that varies according to the electrode size. The electrode arrangement (3) defines a modulable electrolysis surface characterized by a minimum electrolysis surface involving only two electrodes (4) of the smallest possible area and a maximum electrolysis surface involving at most all the electrodes (4) of the electrode arrangement (3).

[0063] The maximum electrolysis surface area may only involve a portion of the electrodes, thus maintaining an inactive electrode population during a production state of the electrolysis system (2). Advantageously, modulating the electrolysis surface area (7c) allows for time-based management of the system's pause or regeneration needs to ensure prolonged use of the hydrogen therapy device. The electrolysis surface area (7c) can be implemented in a multitude of possible combinations. The control system (6) can modulate the management of electrode (4) usage from one production state to another in order to optimize and balance the use of the electrodes (4) over time. Figure 8C shows an example of a plan for alternating the use of the electrodes (4) in the case where the desired electrolysis surface (7c) involves four pairs of electrodes (4) in an electrode arrangement (3) comprising a maximum of six pairs of electrodes (4).

[0064] In a fourth embodiment, it is possible to consider control based on a multitude of application parameters (7), which can also be combinations of the modes described previously. In a first example, the control system (6) modulates the voltage (7a) applied by the electric generator (5) and the duration of the application of the electric current (7b) by the electric generator. In a second example, the control system (6) modulates the electrolysis surface area (7c) of the electrode arrangement (3) and the duration of the application of the electric current (7b) by the electric generator (5). In a third example, the control system (6) modulates the electrolysis surface area (7c) of the electrode arrangement (3) and the voltage (7a) applied by the electric generator (5).In a fourth example, the control system (6) modulates the electrolysis area (7c) of the electrode arrangement (3), the voltage (7a) applied by the electric generator (5), and the duration of the electric current application (7b) by the electric generator (5). For example, the control system (6) can modulate the current of the electric generator (5) within an operating range (9) between 0 mA and 30 mA. The control system (6) measures the voltage between the electrodes (4) and readjusts the electric current setpoint to obtain an electrolysis voltage within the electrolysis range. When the applied voltage is close to its minimum or maximum limits (9a, 9b), the control system (6) modulates the application parameters (7), which in this case are the electrolysis area (7c) and the duration of the production state (7b).

[0065] In either of the preceding embodiments, the control system (6) can be configured to perform a calibration phase at the start of an operating cycle (10). The control system (6) is then configured to perform a calibration phase of the electrolysis system (2) by applying initial values ​​of application parameters (7) of the electric current corresponding to the theoretical value of the application parameter (7) allowing the target quantity of hydrogen to be produced to be reached.

[0066] The quantity of hydrogen can alternatively be delivered in several intermediate quantities. In this alternative, the calibration step can be applied during the The first operating cycle (10) enables the production of a target quantity of hydrogen. The calibration step initializes the application parameters (7) of the production process to deliver the dose according to initial values ​​of the application parameters (7) corresponding to the target value of the production parameter (8) required to produce the target quantity of hydrogen. The application parameters (7) used to produce intermediate quantities of hydrogen during subsequent operating cycles (10) will be modulated based on measurements of the production parameter (8) taken by the control system (6) and the production data from the previous operating cycle (10). Thus, the production of intermediate quantities of hydrogen required to deliver the target quantity of hydrogen is adjusted between each operating cycle (10) to achieve the target quantity of hydrogen.

[0067] Depending on the dosage, it is possible to administer several doses per day or several quantities of hydrogen over a 24-hour period. For example, it is possible to deliver three doses of hydrogen at regular intervals, with each initial operating cycle (10) spaced 8 hours apart. The calibration step can be implemented during the first operating cycle (10) to achieve the production of a certain quantity of hydrogen. The application parameters (7) enabling the production of intermediate quantities of hydrogen during subsequent cycles will be adjusted based on the measurements and production data from the preceding operating cycle (10).

[0068] In either of the preceding embodiments, the control system (6) can modulate the application parameters (7) during a production state. At the start of an operating cycle (10), initial values ​​of the application parameters (7) corresponding to the theoretical value of the application parameter (7) required to achieve the quantity of hydrogen to be produced are initialized. These values ​​may be those predicted during the calibration phase. These values ​​may be those deduced from the previous operating cycle (10).

[0069] In either of the preceding embodiments, the control system (6) can be configured to put the electrolysis system (2) into a regeneration state shown in Figure 9, enabling electrode cleaning. The electrolysis system (2) is put into the regeneration state when it is not in The production state. For example, the regeneration state can be scheduled during the pause period (12). The regeneration state can be pre-programmed to perform regular cleaning of the electrolysis system (2). In this example, the number of operating cycles (10) can be used to determine the frequency at which the regeneration state is triggered.

[0070] The regeneration state can be activated by the control system (6) when the production parameter (8) and the target quantity of hydrogen to be produced are not reached within the operating range (9) of a predetermined application parameter (7), which may be: the duration of the production state (7b), the application of a voltage (7a) outside its operating range (9), or an insufficient electrolysis surface area (7c). Figure 10 illustrates the configuration where operation outside the operating range (9) is a condition for triggering the regeneration state. Prolonged operation beyond a critical duration near the limits (9a and 9b) of the operating range (9) is a second possible condition for triggering the regeneration state.The critical duration can be defined as a duration greater than or equal to 15% of the total duration of an active period, preferably a duration greater than or equal to 25% of the total duration of an active period, more preferably a duration greater than or equal to 50% of the total duration of an active period, even more preferably a duration greater than or equal to 75% of the total duration of an active period.

[0071] The electrode regeneration state (4) can be triggered between two production states. Alternatively, the electrode regeneration state can be triggered to stop the current production state and proceed with electrode cleaning. The various embodiments described for the electrode regeneration states can be combined, allowing for both planned implementation and implementation in response to measurements taken by the control system (6).

[0072] The regeneration state of the electrodes can be achieved by applying an electrical current pulse with a regeneration voltage value outside the electrolysis range. Preferably, the regeneration voltage is greater than the maximum value of the electrolysis range. More specifically, the regeneration voltage is greater than IV, preferably greater than 1.3V, and more preferably between 1.3V and 15V. The regeneration voltage is applied for a period less than 1000 ms, preferably less than 500 ms, and even more preferably between 10 ms and 500 ms. A second embodiment consists of reversing the polarity of the electrodes so as to reverse the direction of the electric current and promote electrode regeneration, for example by facilitating the removal of accumulated impurities. Electrode polarity reversal is achieved using an H-bridge within the control system. The control system (6) can include as many H-bridges as necessary to drive the electrodes (4). In other words, several H-bridges may be required to independently drive each pair of electrodes (4).

[0073] Alternatively, it is possible to put into a regeneration state an electrode surface (3) which has remained in a pause period (12) during an operating cycle (10).

[0074] The invention has been described in relation to modulation based on a production parameter (8) representing the intensity of the electric current, which is representative of the quantity of hydrogen to be produced. Alternatively or in addition, the modulation could be based on any other suitable production parameter (8).

[0075] For example, the production parameter (8) could be a direct measure of the actual quantity of hydrogen produced. For each hydrogen value measured by the control system (6), a current intensity corresponding to a production rate for that quantity of hydrogen can be determined. The measurement of the production parameter (8) by the control system (6) allows the determination of the actual quantity of hydrogen produced. The control system (6) thus enables the control of hydrogen production according to a target value of the production parameter (8), through the direct measurement of the hydrogen quantity. This embodiment requires that the control system (6) be connected to a hydrogen sensor. The hydrogen sensor can be a component of the hydrogen therapy device (1).The hydrogen sensor can be associated with an external device, the hydrogen therapy device (1) being configured to communicate and exchange data with the external device via wifi or bluetooth for example.

[0076] The production parameter (8) could also be a direct measure of a co-product of the electrolysis process that produces hydrogen. For each value of the quantity of a co-product of hydrogen production, there is a quantity of hydrogen actually produced. The co-product sensor can be An element of the hydrogen therapy device (1). The co-product sensor can be connected to an external device, the hydrogen therapy device (1) being configured to communicate and exchange data with the external device via Wi-Fi or Bluetooth, for example. As in the previous mode, for each value of the quantity of a hydrogen production co-product measured by the control system (6), there is a corresponding current intensity that corresponds to a production rate of that quantity of hydrogen. The measurement of the production parameter (8) by the control system (6) allows the quantity of hydrogen produced to be determined. The control system (6) thus enables the management of hydrogen production according to a target value for the quantity of hydrogen co-product resulting from the electrolysis reaction of the body fluid. These co-products originate from the electrolysis of other molecules present in the body fluid.This embodiment requires that the control system (6) include a sensor enabling the detection of the co-product of hydrogen production. The co-products that can allow the indirect measurement of hydrogen production can be, alone or in combination, gluconic acid, glucuronic acid, glucaric acid, aldehydes and ketones resulting from the oxidation of amino acids and fatty acids available in the interstitial fluid, and pyruvate.

[0077] In either of the embodiments described above, the control system (6) may include a communication interface configured to communicate with an external operator. The external operator transmits production parameters (8) representative of the quantity of hydrogen to be produced to the control system (6) via the communication interface. In other words, the communication interface can receive instructions corresponding to the dosage of a treatment and send hydrogen production data to an external operator. The transmission can be carried out via a connection. The transmission can be performed using wireless communication methods such as Bluetooth or Wi-Fi.

[0078] An example of a hydrogen therapy procedure implementing the hydrogen therapy device (1) is now described in relation to Figure 10.

[0079] The hydrogen therapy process may include a device parameterization step (100) to define the production parameters (8) and application parameters (7, 7a, 7b, 7c) in order to produce a suitable quantity of hydrogen for the patient treatment. This device parameterization step can also allow adjustment of the operating ranges (9) of the hydrogen therapy device (1).

[0080] The production of the quantity of hydrogen begins by bringing the hydrogen therapy device (1) to the production state (101). Once the hydrogen therapy device (1) is in the production state (101), the control system (6) modulates the application parameters (7, 7a, 7b, 7c) to reach a target value during the target value attainment step (102). The target value attainment step (102) corresponds to an intermediate duration of the production state between two measurement steps of the production parameter (103), during which the electric current is established within the electrode arrangement (3) according to the application parameters (7, 7a, 7b, 7c). The target value attainment step (102) thus corresponds to an interval between two measurement steps of the production parameter (103). The duration of step (102) can be adjusted according to the amount of hydrogen to be produced and the duration of the treatment.In an alternative mode, this duration can be fixed.

[0081] In a measurement step of a production parameter (103) representative of the hydrogen produced, the control system (6) measures the production parameter (103) in order to compare the measured value with the target value of hydrogen production, parameterized during the parameterization step of the device (100).

[0082] The hydrogen therapy process includes a step of controlling the electric generator (5) by the control system (6) according to the production parameter (8) to deliver the quantity of hydrogen.

[0083] If the active period of an operating cycle (10) is completed, the control system (6) checks whether the amount of hydrogen produced is greater than or equal to the target amount. If the amount of hydrogen produced is less than the target amount, a regeneration state (104a) is triggered before the start of the next operating cycle (10) and the next production state (101). If the amount of hydrogen produced is greater than or equal to the target amount, the control system (6) triggers the update of the next operating cycle (105), during which the application parameters (7) of the electrical current are adjusted to modulate the hydrogen production of the next operating cycle (10).

[0084] If the active period of an operating cycle (10) is not completed, the control system (6) determines whether the amount of hydrogen produced exceeds the target amount. When the amount of hydrogen produced exceeds the target amount while the active period is not completed, electrolysis is stopped (106). During the stop electrolysis step (106), it is possible to proceed to the next operating cycle update step (105) before the next production phase (101).

[0085] If the active period of an operating cycle (10) is not completed, and the control system (6) determines that the amount of hydrogen produced is less than the target amount of hydrogen, then the control system (6) measures the rate of hydrogen production and compares it with the target rate of hydrogen production.

[0086] If the hydrogen production rate is lower than the target hydrogen production rate and the value of the application parameter (7) is lower than the maximum limit (9b) of its operating range (9), then the control system (6) modulates the application parameter (107) to increase the value of the application parameter (7). Then the control system (6) resumes at the target value attainment step (102).

[0087] If the hydrogen production rate exceeds the target hydrogen production rate and the value of the application parameter (7) exceeds the minimum limit (9a) of its operating range (9), then the control system (6) modulates the application parameter (7) to decrease the value of the application parameter (108). The control system (6) then resumes at the target value attainment step (102).

[0088] When it is necessary for an application parameter (7) to be placed outside its operating range (9) to allow the production of a quantity of hydrogen according to the values ​​of the production parameter (8) obtained during the measurement of the production parameter (103) by the control system (6), then a regeneration state (104b) is triggered. This regeneration state can be immediate, after the cessation of electrolysis during a transition to the stop electrolysis step (106). Alternatively, the regeneration state (104b) can be triggered when the active period is over. Alternatively, the regeneration state (104b) can be triggered when the application parameter (7) of the electric current is applied for a prolonged period in the vicinity of its operating terminals. 5

Claims

DEMANDS 1. Hydrogen therapy device (1) for delivering a quantity of hydrogen in situ by electrolysis of a body fluid, the hydrogen therapy device (1) comprising: - an electrolysis system (2) configured to perform electrolysis of body fluid, the electrolysis system (2) comprising: an electrode arrangement (3) comprising at least two implantable electrodes (4), the electrode arrangement (3) being configured to apply an electric current to the body fluid, and an electric generator (5) configured to apply the electric current between the electrodes (4), - a control system (6) configured to put the electrolysis system (2) into a production state in which said electrolysis system (2) carries out the electrolysis of the body fluid according to a plurality of application parameters (7) of the electric current adapted to produce hydrogen, in which at least one of the application parameters (7) is modulable and the control system (6) is configured to measure a production parameter (8) representative of the hydrogen produced, and to modulate the modulable application parameter (7) of the electrolysis system (2) according to the production parameter (8) to deliver the quantity of hydrogen.

2. Hydrogen therapy device (1) according to claim 1, wherein the electric generator is configured to apply the electric current with a modulating voltage (7a), the application parameter (7) comprising the voltage of the electric generator (7a).

3. Hydrogen therapy device (1) according to any one of claims 1 and 2, wherein the control system (6) is configured to modulate a duration of the production state (7b), the application parameter (7) comprising the duration of the production state.

4. Hydrogen therapy device (1) according to any one of claims 1 to 3, wherein the electrode arrangement (3) has a tunable electrolysis surface (7c), the plurality of application parameters (7) comprising the electrolysis surface of the electrode arrangement (3).

5. Hydrogen therapy device (1) according to any one of claims 1 to 4, wherein the control system (6) is configured to control the electrolysis system (2) so as to produce the quantity of hydrogen over a treatment time comprising at least one operating cycle (10), the operating cycle comprising an active period (11) in which said electrolysis system (2) is in the production state, and a pause period (12) in which the electrolysis system (2) is not in the production state.

6. Hydrogen therapy device (1) according to claim 5, wherein the control system (6) is configured to control the electrolysis system (2) according to at least two operating cycles (10) such that the active periods (11) and the pause periods (12) are alternated.

7. Hydrogen therapy device (1) according to any one of claims 1 to 6, wherein the control system (6) is configured to put the electrolysis system (2) into a regeneration state (13) distinct from the production state, the electrolysis system (2) in the regeneration state (13) being configured to clean the electrodes (4).

8. Hydrogen therapy device (1) according to claim 7, wherein the control system (6) is configured to put the electrolysis system (2) into the regeneration state (13) when a target production parameter (8) is not reached within a time window.

9. Hydrogen therapy device (1) according to any one of claims 7 and 8, wherein the control system (6) is configured to modulate the application parameter (7) of the electric current within an operating range (9) between two terminals (9a, 9b), and to put the electrolysis system (2) into the regeneration state (13) when said electrolysis system (2) has remained in the state of production with the application parameter (7) in the vicinity of the bounds (9a, 9b) for a critical duration.

10. Hydrogen therapy device according to any one of claims 7 to 9, wherein the control system (6) is configured to, in the regeneration state (13) of the electrolysis system (2), reverse one polarity of the electrodes (4).

11. Hydrogen therapy device (1) according to any one of claims 7 to 10, wherein the control system (6) is configured to, in the production state, apply electric current with an electrolysis voltage within an electrolysis range and, in the regeneration state (13) of the electrolysis system (2), apply an electric current pulse having a regeneration voltage outside the electrolysis range.

12. Hydrogen therapy device (1) according to any one of claims 1 to 11, in which the control system (6) is configured to perform a calibration phase of the electrolysis system (2) according to initial values ​​of the application parameters (7).

13. Hydrogen therapy device (1) according to any one of claims 1 to 12, in which the electric current has an intensity and the production parameter (8) is based on the intensity of the electric current.

14. Hydrogen therapy device according to any one of claims 1 to 13, wherein the control system (6) includes a communication interface configured to communicate with an external operator.

15. Hydrogen therapy device according to any one of claims 1 to 14, wherein the electrolysis system (2) further comprises an implantable housing (40) and a battery electrically connected to the electric generator (5), the electric generator (5) and the battery being located in the implantable housing (40), the battery being remotely rechargeable by external, non-implantable equipment.

16. Hydrogen therapy system comprising a hydrogen therapy device (1) according to claim 15 and external non-implantable equipment (20) configured to recharge the battery remotely.

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