Device for supplying therapeutic gas, particularly NO or N.SUB.2.O, to a patient

Abstract

Disclosed is a device for supplying therapeutic gas, notably NO/N.sub.2 or O.sub.2/N.sub.2O mixtures, including an internal passage with a valve for conveying and controlling the flow of therapeutic gas in the internal passage, a control unit controlling the valve, a graphic display for displaying choices that can be selected by a user, and a selector, such as touch-sensitive keys displayed on the graphic display for making a selection from among the selectable choices displayed on the graphic display. The control unit is configured to count a total number of patients treated by administration of the therapeutic gas from the selection, by a user, via the selector, of a first given choice corresponding to the start of a treatment by administering the therapeutic gas to a patient concerned.

Claims

1. A device for supplying therapeutic gas, comprising: an internal passage through which flow of the therapeutic gas between a gas inlet and a gas outlet is to be conveyed, at least one valve configured to control the flow of the therapeutic gas in the internal passage, a controller configured to control the at least one valve, a graphic display configured to display choices that can be selected by a user, and a user interface configured to allow a selection by the user from among the choices displayed on the graphic display, wherein the controller is configured to count a total number (N) of patients treated by administration of the therapeutic gas from the selection, by the user, via the user interface, of a first given choice corresponding to a start of a treatment by administering the therapeutic gas to a patient concerned, wherein the controller is configured to determine a total duration of treatment for each patient treated which corresponds to a period of time elapsed between the user selecting: the first given choice corresponding to the start of treatment by administering the therapeutic gas to the patient concerned, and a second given choice corresponding to an end of treatment by administering the therapeutic gas to the patient concerned, and wherein the controller is configured to determine, from the total number (N) of patients treated, which has been counted up, and from the total durations of treatment determined for the patients treated: a number of short treatments (TC) for which the total duration of treatment is below a preset threshold duration, and a number of long treatments (TL) for which the total duration of treatment is above the preset threshold duration.

2. The device according to claim 1, wherein the controller is configured to cooperate with the graphic display to display the total number (N) of patients treated.

3. The device according to claim 1, wherein the controller comprises at least one microprocessor.

4. The device according to claim 1, wherein the user interface comprises selection keys or the graphic display comprises a touchscreen.

5. The device according to claim 4, wherein the graphic display comprises the touchscreen and the selection keys are virtual keys displayed on the touchscreen.

6. The device according to claim 1, wherein the user interface is configured to count the total number (N) of patients treated by incrementing a patients counter.

7. The device according to claim 1, wherein the controller is configured to increment the total number (N) of patients treated by +1 in response to the selection, by the user, of the first given choice corresponding to the start of treatment by administering the therapeutic gas to the patient concerned.

8. The device according to claim 1, wherein the controller is configured to: temporarily interrupt determining the total duration of treatment for the patient concerned after: either the user selects the second given choice corresponding to the end of treatment, or the user selects a third given choice corresponding to a suspension of treatment with temporary interruption of the administration of the therapeutic gas to the patient concerned, and resume determining the total duration of treatment for the patient concerned after: either the user reselects the first given choice corresponding to the start of treatment by administering the therapeutic gas, or the user selects a fourth given choice corresponding to a resumption of treatment by administering the therapeutic gas to the patient concerned.

9. The device according to claim 8, wherein the controller is configured not to increment a patients counter after the user reselects the first given choice corresponding to the start of treatment or selects the fourth given choice corresponding to the resumption of treatment for the patient concerned.

10. The device according to claim 1, wherein the controller is configured to cooperate with the graphic display to also display the number of short treatments (TC) and/or the number of long treatments (TL).

11. An installation for administering the therapeutic gas to a patient, comprising: at least one source of the therapeutic gas, the device according to claim 1, configured to be supplied with the therapeutic gas by the at least one source of the therapeutic gas, and a gas supply line configured to be supplied with the therapeutic gas by the device.

12. The installation according to claim 11, further comprising a medical ventilator in fluidic communication with the gas supply line.

13. The installation according to claim 11, wherein the at least one source of the therapeutic gas contains an NO/N2 or O2/N2O mixture.

14. The device according to claim 1, wherein the controller is configured to count the total number (N) of patients treated by incrementing a patients counter, and wherein the patients counter is a counter internal to a microprocessor.

15. The installation according to claim 11, wherein the at least one source of the therapeutic gas includes an NO/N2 or O2/N2O mixture stored in one or more gas containers.

16. The device according to claim 1, wherein the controller comprises at least one microcontroller.

17. The device according to claim 2, wherein the controller comprises at least one microprocessor.

18. The device according to claim 6, wherein the controller is configured to increment the total number (N) of patients treated by +1 in response to the selection, by the user, of the first given choice corresponding to the start of treatment by administering the therapeutic gas to the patient concerned.

19. A device for supplying therapeutic gas, comprising: an internal passage through which flow of the therapeutic gas between a gas inlet and a gas outlet is to be conveyed, at least one valve configured to control the flow of the therapeutic gas in the internal passage, a graphic display configured to display choices that can be selected by a user, a user interface configured to allow a selection by the user from among the choices displayed on the graphic display, and circuitry configured to: control the at least one valve, count a total number (N) of patients treated by administration of the therapeutic gas from the selection, by the user, via the user interface, of a first given choice corresponding to a start of a treatment by administering the therapeutic gas to a patient concerned, determine a total duration of treatment for each patient treated which corresponds to the period of time elapsed between the user selecting: the first given choice corresponding to the start of the treatment by administering the therapeutic gas to the patient concerned, and a second given choice corresponding to an end of the treatment by administering the therapeutic gas to the patient concerned, and determine, from the total number (N) of patients treated, which has been counted up, and from the total durations of treatment determined for the patients treated: i) a number of short treatments (TC) for which the total duration of treatment is below a preset threshold duration, and ii) a number of long treatments (TL) for which the total duration of treatment is above the preset threshold duration.

20. The device according to claim 19, wherein the circuitry is further configured to cooperate with the graphic display to also display the number of short treatments (TC) and/or the number of long treatments (TL).

Description

(1) The invention will now be better understood by virtue of the following detailed description, which is given by way of non-limiting illustration, and with reference to the appended figures, in which:

(2) FIG. 1 schematically indicates one embodiment of a therapeutic-gas supply device according to the invention,

(3) FIG. 2 schematically indicates one embodiment of a gas administering installation according to the invention, and

(4) FIG. 3 schematically indicates one embodiment of a screen of the gas supply device according to the invention.

(5) FIG. 1 schematically indicates one embodiment of a therapeutic-gas supply device 1 according to the invention, comprising a rigid housing 13, for example made of polymer, in which there is arranged an internal passage, such as a duct, for conveying a flow of therapeutic gas.

(6) In this embodiment, we consider, by way of example of a therapeutic gas, a flow of gas based on NO, namely a mixture of nitric oxide and of nitrogen, or NO/N.sub.2.

(7) The flow of NO-based gas enters and circulates in the internal passage between a (or more than one) gas inlet 3 and a gas outlet 4. The gas inlet 3 and outlet 4 may for example be borne by connectors or mechanical-connection and fluidic-connection end fittings borne by the housing 13 of the device 1, to which gas lines used for conveying the gas, for example flexible tubes or the like, can be attached, as explained hereinafter.

(8) Valve means 5, i.e. a (or more than one) valve device(s), for example a plurality of electrovalves arranged in parallel, are arranged on the internal passage and allow control of the flow of therapeutic gas that circulates in the internal passage 2 in the direction extending from the gas inlet 3 to the gas outlet 4. Of course, use may also be made of other valve means, for example a (or more than one) proportional (electro)valve(s).

(9) The valve means 5 are operated by control means 6, i.e. a (or more than one) control device(s), arranged in the housing 13, typically an electronic board comprising a (or more than one) microprocessor(s), typically a (or more than one) microcontroller(s), running one or more algorithm(s). The control means 6 notably make it possible to adjust or control the flow rate of gas passing through the valve means 5.

(10) In this way, the control means 6 can control the valve means 5, such as electrovalves arranged in parallel, and namely can open or close all or some of these valves in order to obtain a gas flow rate (Q) determined/calculated by the microcontroller on the basis of a value that is regulated/set for example by the user, and as a function of the flow rate (Q′) of gas, i.e. air, delivered by the ventilator 23, as explained hereinafter.

(11) A (or more than one) flowmeter (not depicted) is also provided, this being arranged on the internal passage, upstream and/or downstream of the valve means 5 so as to determine the flow rate (Q) of NO-based gas. The flowmeter may be of the differential-pressure, hot-wire or some other type. It cooperates with the control means 6 in order to supply them with measurements.

(12) Moreover, the housing 13 comprises a graphic display 7, preferably a touchscreen, used to display various items of information or data, particularly various choices 9a-9d that a user can select. These choices may be displayed in windows or the like displayed on the touch/digital screen of the graphic display 7.

(13) The graphic display 7 is also configured to show one or more curves, graphs, alarms, icons, etc. or any other item of information or data of use to the user, such as the care-giving staff.

(14) Also provided are selection means 8, i.e. a (or more than one) selection device, allowing the user to make a selection among the selectable choices 9a-9d which are displayed on the graphic display 7, namely to choose between several options proposed and displayed on the screen, or to confirm/validate or reject a choice (i.e. an option), or else to make adjustments or settings, for example to select the desired value for the flow rate.

(15) The selection means 8 typically comprise selection keys or buttons that the user can actuate. Advantageously, the selection means 8 are virtual keys operated by touch, namely touch-sensitive keys, displayed on the graphic display 7 which is itself a touchscreen.

(16) According to the present invention, the control means 6 are also configured to count a total number (N) of patients treated by administration of the therapeutic gas from the selection, by a user, via the selection means 8, particularly a touch-sensitive key displayed on the graphic display 7, of a first given choice 9a corresponding to the start of a treatment by administering the therapeutic gas to a patient concerned. For example, the start of a treatment may be initiated by the user pressing with a digit on a “Start treatment” key that commands the start of the supply of therapeutic gas.

(17) The total number (N) of patients treated is counted by incrementing a counter, for example a counter of the microprocessor or the like, in increments of +1.

(18) Stated differently, as soon as a treatment by administering therapeutic gas, such as NO, to a patient is to begin, the user presses on the “Start treatment” touch-sensitive key displayed on the graphic display 7, which corresponds to the initiation, i.e. the starting, of this treatment, and this increments by +1 the counter which keeps count of the total number (N) of patients treated.

(19) The total number (N) of patients treated may be displayed on the graphic display 7 either permanently, or on demand from the user, for example after pressing a dedicated key.

(20) As illustrated in FIG. 1, the graphic display 7 may display several selectable choices 9a-9d each corresponding to a specific given action.

(21) For example, the display 7 may display, in the form of keys or the like: a first given choice 9a corresponding to a start of the treatment by administering the therapeutic gas to the patient, namely a “Start treatment” key; a second given choice 9b corresponding to the end of the treatment of the patient concerned, namely an “End treatment” key; a third given choice 9c corresponding to a suspension of the treatment with temporary interruption of the administration of therapeutic gas to the patient concerned, namely a pausing of the treatment by selecting a “Pause treatment” key; and a fourth given choice 9d corresponding to the resumption of the treatment of the given patient by selecting a “Resume treatment” key.

(22) The user's selection of one of these choices 9a-9d, for example by pressing with a digit on the virtual key, for example a window or the like, of the touchscreen of the display 7, will be transmitted to the microprocessor of the control means 6 and the latter will control the operation of the apparatus according to the selection made.

(23) For example, the control means 6 may command the valve means 5 to: allow gas to circulate in the internal passage 2, through the flow-control electrovalve(s) according to the set flow rate (Q), in the direction of the patient if the key pressed corresponds to the first given choice 9a, namely corresponds to starting treatment by administering the therapeutic gas to the patient, namely corresponds to the “Start treatment” key; interrupt the circulation of gas in the internal passage 2 in the direction of the patient if the key pressed corresponds to the second or third given choice 9b or 9c, and therefore corresponds to a definitive or temporary stopping of the treatment of the patient, namely corresponds to an “End treatment” or “Pause treatment” key; and allow gas to circulate once again in the internal passage 2, in the direction of the patient, if the key pressed corresponds to the fourth given choice 9d, after the pressing of the key for the third given choice 9c synonymous with temporarily stopping the treatment, i.e. temporarily pausing the treatment, by selecting the “Resume treatment” key.

(24) In the embodiment of FIG. 1, the 4 choices 9a-9d are individual keys each performing a specific action. However, some of the actions/choices could, according to other embodiments, be selected using the one same key, which means to say that the one same key could be used to select a number of different choices.

(25) For example, the third and fourth given choices 9c and 9d are displayed in the form of two, “Pause treatment” and “Resume treatment”, virtual keys or the like. However, according to another embodiment, these third and fourth given choices 9c, 9d could be selected by the one same “Pause/Resume treatment” virtual key.

(26) Likewise, according to yet another embodiment, the first, third and fourth given choices 9a, 9c, 9d could be selected by the one same “Start/Pause/Resume treatment” virtual key.

(27) According to yet another embodiment, the one same key could command the start and resumption of the treatment after a pause, and another key could command the temporary pausing and the definitive ending of the treatment.

(28) Of course, other combinations or embodiments are also possible.

(29) In all cases, a pressing, i.e. selection by the user, on the key or the like corresponding to the first given choice 9a, namely to a start of treatment in a patient concerned (i.e. new patient), causes the counter of the number of patients treated to be incremented by +1 and no further incrementation by +1 can take place until after the key corresponding to the second given choice 9b, namely the key signalling the definitive end of treatment of the patient concerned, has been pressed. It must be emphasized that a selection of given choices 9c, 9d corresponding to pausing and/or resuming a treatment does not lead to any incrementing of the counter.

(30) According to a variant embodiment, the start of a treatment by administering therapeutic gas to a patient cannot begin until after the user has validated, i.e. confirmed, the first given choice selected by pressing the “Start treatment” key; as a preference, validation is performed by the user selecting a dedicated Validate key, particularly a virtual Validate key displayed on the graphic display 7 as detailed hereinbelow.

(31) In other words, the control means 6 are configured to operate the valve means 5 and begin the supply of therapeutic gas only after the user has selected the first given choice of “Start treatment” and then confirmed this choice by pressing the Validate key.

(32) Furthermore, according to a more sophisticated embodiment of the invention, the control means 6 are also configured to determine a total treatment duration for each patient treated which corresponds to the period of time elapsed between the user selecting the first given choice 9a corresponding to the start of a treatment by administering the therapeutic gas to a patient concerned, and the second given choice 9b corresponding to the definitive end of the treatment by administering therapeutic gas to the patient concerned.

(33) As a result, the control means 6 are configured to temporarily interrupt, i.e. stop, determining the total treatment duration for a patient concerned after the user selects the third given choice 9c corresponding to pausing the treatment with temporary interruption of the administration of therapeutic gas to the patient concerned, and then resume determining the total treatment duration after: either the user reselects the first given choice 9a corresponding to the start of a treatment by administering the therapeutic gas, or the selection of a fourth given choice 9d corresponding to resumption of a treatment by administering the therapeutic gas to the patient concerned.

(34) According to yet another embodiment of the invention, the control means 6 may also be configured to determine: the number of short treatments (TC) for which the total treatment duration is below a preset threshold duration, i.e. the number of patients that have undergone such a short-duration treatment, for example of under 3 h, and/or the number of long treatments (TL) for which the total treatment duration is above the preset threshold duration, where TL=N−TC, where N is the total number of patients treated, i.e. the number of patients that have undergone such a long-duration treatment, for example of over 3 h, and which may last for as much as 1 to several days.

(35) The control means 6 cooperate with the graphic display 7 to display 11, 12 the value or values thus determined, namely the number of short treatments (TC) and/or the number of long treatments (TL).

(36) Specifically, being able to determine and display the number of short treatments (TC) and the number of long treatments (TL) out of the total number of patients treated, namely the total number of treatments given using the device concerned, makes it possible to make a distinction between those patients that have been responsive to the treatment, which is to say those for whom the gas has worked, and those for whom the gas has had no therapeutic effect despite having been administered for a minimum duration, which is to say a duration that may reach the preset threshold duration. Such information is very useful to the care-giving staff, notably in order to decide whether perhaps to change the treatment.

(37) For example, for an iNO treatment, said threshold duration may be set at 3 hours or at some other “short” duration. Treatments that are stopped before the 3-hour mark will be counted as short treatments (TC) that have had no appreciable or proven therapeutic effect in the patients, and those which have lasted at least 3 hours will be counted as long treatments (TL) that have had a beneficial effect on the patients.

(38) In general, the counting of the patients treated with the gas administering device 1 of the invention is handled by an algorithm run by a microprocessor of the control means 6 of the device 1. This algorithm counts up the total number (N) of patients treated by incrementing a counter. This number N is displayed on the graphic display 7 in order to provide this information to the user. It is preferably recorded in a non-volatile memory.

(39) Advantageously, the device 1 is also able to take into account the starting of a complete new treatment (i.e. new treatment for a new patient), a temporary pausing of treatment, the resumption of a treatment of an unstable patient in the withdrawal phase (i.e. resumption of a treatment that had been paused) and a “short” treatment when the duration of administration of a new treatment is less than a few hours (i.e. preset threshold duration), signifying that the patient is not responding to the treatment given.

(40) The unique triggering event that causes the counter of the total number (N) of patients treated to be incremented by +1 is the action of selecting a first given choice 9a displayed on the touchscreen of the display 7 corresponding to “Start new treatment” by pressing a virtual key or the like displayed on the screen, corresponding to this first given choice 9a.

(41) When it is necessary to temporarily pause the treatment of a given patient, the device 1 may offer a choice or a selection corresponding to temporarily pausing the treatment, in the form of a dedicated third given choice 9c of the “Pause treatment” type, as explained hereinabove.

(42) When resuming a treatment, for example after a lengthy pause, the device 1 may request confirmation, i.e. validation of the choice, before incrementing the counter, for example by asking the user to select a “Yes” or “No” answer to a question of the type: “Is this a new patient?” and by offering two possible choices of answer “Yes” and “No” in the form of two virtual keys displayed on the screen. The answer “No” is treated by the device 1 as being a restart after a pause in treatment and not as a new patient; therefore the counter is not incremented.

(43) The total treatment time is determined by the control means 6 as being the duration extending between the user pressing the first given choice 9a signifying “Start new treatment” and subsequent pressing on another key corresponding to a choice 9b of the “Stop treatment” type, or even on another key corresponding to a third given choice 9c of the “Pause treatment” type with the treatment not then being subsequently resumed with the same patient, as explained hereinabove.

(44) Advantageously, the display 7 displays not only the total number (N) of patients treated (at 10) but also the number of short treatments TC (at 11) and the number of long treatments TL, which is to say complete treatments (at 12). The total number (N) of patients treated is equal to the sum of the total number of long treatments and the number of short treatments (i.e. N=TL+TC).

(45) The display 10, 11, 12 of all or some of the values N, TL and TC may be available permanently on the graphic display 7 or else may appear on the screen only after being called up by the user, for example by pressing a dedicated key or the like.

(46) FIG. 2 schematically indicates one embodiment of a gas administering installation 20 according to the invention, in this instance comprising two cylinders 21 of therapeutic gas, namely in this instance NO/N.sub.2 mixtures, for example containing 800 ppm by volume of NO (the rest being N.sub.2), which supply an NO/N.sub.2 mixture to a therapeutic-gas supply device 1 according to the invention, as illustrated in FIG. 1 and described hereinabove.

(47) The gas cylinders 21 are fluidically connected to the gas supply device 1 via gas conveying lines 30, such as flexible tubes or the like, which may be fitted with gas-pressure regulating and/or monitoring devices 31, such as pressure regulators, pressure gauges, etc. The gas conveying lines 30 are connected to one or more gas inlets 3 of the gas supply device 1 which supply the internal passage 2 of said gas supply device.

(48) It will be noted that the gas supply device 1 also comprises an oxygen inlet 32 fluidically connected, via an oxygen conveying line 34, such as a flexible tube or the like, to a source of oxygen, for example the hospital network, namely an oxygen supply line running through the hospital building.

(49) Furthermore, a medical ventilator 23, namely a respiratory assistance apparatus, is also provided to supply air or an oxygen/nitrogen (N.sub.2/O.sub.2) mixture, namely a flow of respiratory gas containing at least 21% oxygen.

(50) The medical ventilator 23 and the gas supply device 1 are in fluidic communication with a gas supply line 22 used to carry the flow of gas to the patient.

(51) The gas supply device 1 delivers an NO/N.sub.2 mixture, for example 800 ppmv of NO, into the gas supply line 22, via an injection pipe 37, so as to inject (at 37a) a flow of NO/N.sub.2 into the flow of air or of oxygen/nitrogen mixture delivered by the medical ventilator 23.

(52) The gas supply line 22 further comprises a gas humidifier 24 arranged downstream of the flow rate sensor (at 36) at which the therapeutic-gas supply device 1 is fluidically connected to the supply line 22. This gas humidifier 24 allows the flow of gas, e.g. NO/N.sub.2/air mixture, to be humidified before it is inhaled by the patient, via a patient respiratory interface, such as a tracheal tube or the like. In FIG. 2 the patient/interface assembly is indicated schematically as an “artificial lung” 25.

(53) A line 27 for recovering the gases exhaled by the patient is also provided. The gas supply line 22 and the exhaled-gas recovery line 27 are connected to a connection piece 28, preferably a connection piece 28, and thus define a patient circuit 29. The gas supply line 22 forms the inspiratory branch of the patient circuit 29, while the exhaled-gas recovery line 27 forms the expiratory branch of the patient circuit 29.

(54) The gas supply line 22 is fluidically connected to an outlet port 23a of the medical ventilator so as to collect and convey the gas, typically air (or an N.sub.2/O.sub.2 mixture containing around 21% O.sub.2), delivered by the medical ventilator 23, while the exhaled-gas recovery line 27 is fluidically connected to an inlet port 23b of the medical ventilator 23 so as to supply the medical ventilator 23 with all or some of the flow of gases exhaled by the patient.

(55) The exhaled-gas recovery line 27 may comprise one or more other optional components 26, such as, for example, a device for eliminating the CO.sub.2, i.e. a CO.sub.2 trap, such as a hot pot or the like, allowing the removal of the CO.sub.2 present in the gases exhaled by the patient, or a filter or the like. Specifically, a device for eliminating the CO.sub.2 may prove beneficial when the gas contains N.sub.2O that needs to be recovered after it has been exhaled by the patient. The exhaled-gas recovery line 27 is used, in the case of NO, by the ventilator 23 to check whether there is a gas leak in the line 22, 27 for example.

(56) A flow rate sensor 36, for example of the hot-wire or differential-pressure type, is also provided, connected to the gas supply device 1 via a flow rate measurement line 35 used for measuring the flow rate of gas (Q′), such as air (i.e. N.sub.2/O.sub.2), coming from the ventilator 23, within the supply line 22 upstream of the point (at 37a) of NO/N.sub.2/air connection and mixing. As explained hereinabove, this notably allows the passage of the NO through the valve means of the device 1 to be regulated.

(57) Furthermore, a gas withdrawing line 38 fluidically connecting the gas supply device 1 to the supply line 22 in the vicinity of the Y-piece 28 may be provided so that samples of gas can be taken and their compliance with the desired mixture that is to be administered to the patient verified. The withdrawing line 38 is connected to the line 22 downstream of (at 38a) the point 37a of connection of the injection pipe 37, when considering the direction in which the flow of gas circulates from the ventilator 23 towards the patient.

(58) FIG. 3 schematically indicates one embodiment of the screen of the graphic display 7 for a gas supply device 1 according to the invention, and which is configured to display various items of information, such as the NO, O.sub.2 and NO.sub.2 concentrations in the gas but also, according to the invention, a “Start treatment” touch-sensitive key (i.e. window) allowing the user, i.e. a caregiver, to select a first given choice 9a corresponding to the starting of a treatment by administering NO to a patient, and also incidentally the number “N” (at 10) of patients that have been treated with this device 1.

(59) In this embodiment, the other choice or choices 9b-9d are not displayed until after the user has selected the first given choice 9a, i.e. until after the window that forms a touch-sensitive key on the touchscreen has been pressed.

(60) Because the problems with recording the number of patients treated is a wide-ranging problem for public and private hospital settings alike, the device of the invention can be used for treatments other than that of inhaled nitric oxide, i.e. iNO, for example for treatments using an equimolar mixture of oxygen and nitrous oxide, such as MEOPA, or using other gases, for example argon.