DEVICE AND METHOD FOR DETERMINING AN INFORMATION RELATING TO A TREATMENT

Abstract

The present invention pertains to a device and corresponding method for determining information relating to the treatment of a patient, preferably relating to a patient having a respiratory disorder. The device comprises a fluid channel configured to be in fluid communication with a medical gas source at a first end and with a patient interface at a second end, a sensor arrangement having at least a first sensor for measuring a value of a first flow parameter in the channel and a second sensor for measuring a value of a second flow parameter in the channel, wherein the first sensor and the second sensor are spaced apart from each other along a longitudinal axis of the channel, and a control unit in communication with the first sensor and the second sensor. The control unit determines flow direction of a medical gas in the channel based on sensor measurements.

Claims

1. Device for determining information relating to an adherence of a patient having a respiratory disorder, comprising: a fluid channel configured to be in fluid communication with a medical gas source at a first end and with a patient interface at a second end, a sensor arrangement having at least a first sensor for measuring a value of a first flow parameter in said channel and a second sensor for measuring a value of a second flow parameter in said channel, and a control unit in communication with the first sensor and the second sensor, wherein the control unit is configured to determine a flow direction of a medical gas in the channel based on a received measurement of the first sensor and/or second sensor and to determine the information based on the determined flow direction wherein the first sensor and the second sensor are spaced apart from each other along a longitudinal axis of the channel and are arranged at opposing ends of the channel, wherein the device is configured such that either end of the channel is configured to be coupled to a medical gas source or a patient interface, wherein the determined information indicates a coupling orientation of the device, and wherein the control unit is configured to select a particular sensor based on the coupling orientation and the relative position of the sensor to perform a measurement of a flow characteristic at a downstream end of the channel.

2. Device according to claim 1, wherein the first sensor and the second sensor are configured to measure the same flow parameter and wherein the control unit is configured to calculate a differential pressure calculated from the measurements of the first sensor and the second sensor, or wherein one of the sensors is configured as a differential pressure sensor to measure a differential pressure, wherein the control unit determines the flow direction based on the determined differential pressure.

3. Device according to claim 1, wherein the device is configured to output a visual and/or an acoustic alarm based on the determined information.

4. Device according to claim 3, wherein the device comprises a signaling device, preferably a display, to output the signal on the device, or wherein the device comprises a communication device to communicate the signal to an external and/or coupled device to output said signal.

5. Device according to claim 1, wherein at least one of the sensors is configured as a flow sensor or pressure sensor, wherein the at least one flow sensor is configured to measure a respiratory parameter of the patient based on the determined flow direction and the measurement value of the at least one flow sensor or pressure sensor, wherein the control unit is configured to determine the information based on the measured respiratory parameter.

6. Device according to claim 5, wherein the device furthermore comprises an evaluation unit in communication with the control unit, wherein the evaluation unit is configured to determine a physiological parameter of the patient based on the measured respiratory parameter of the patient, wherein the control unit determines the information based on the determined physiological parameter of the patient, the information preferably comprising an exacerbation prediction of the patient.

7. Device according to claim 6, wherein the evaluation unit is configured to evaluate the measured respiratory parameter comprising a breathing pattern or rhythm, an exhalation and/or inhalation time, a breathing volume, a dynamic flow measurement, a breathing or maximal lung capacity, and/or a breathing pulse, preferably over a predefined time and/or at predefined intervals to determine the physiological parameter.

8. Device according to claim 6, wherein the evaluation unit is configured to determine the flow rate and/or the flow volume of a medical gas and/or a change thereof provided in the channel, preferably over a predefined time and/or at predefined intervals, wherein the control unit determines the information based on the determined flow rate and/or the flow volume of the medical gas.

9. Device according to claim 5, wherein the device comprises a monitoring unit in communication with the control unit, wherein the monitoring unit is configured to compare the determined information, the measured respiratory parameter, and/or the determined physiological parameter with a corresponding threshold or control logic stored in the monitoring unit and is configured to automatically output a signal, when said threshold is exceeded and/or based on a value of said control logic.

10. Device according to claim 6, wherein the evaluation unit is configured to store the determined information, the measured respiratory parameter of the patient, and/or the determined physiological parameter of the patient in a database of the device and/or wherein the device comprises a communication device to communicate the determined information, the measured respiratory parameter of the patient, and/or the determined physiological parameter of the patient to an external database for remote storage.

11. Device according to claim 5, wherein the control unit is configured to be in communication with a pressure regulator of the medical gas source and/or of the patient interface to automatically adjust the medical gas flow based on the determined information and/or on a comparison of the determined information with a prescribed treatment of the patient provided in the control unit.

12. Device according to claim 11, wherein the control unit is furthermore configured to be in communication with a remote control device to control the pressure regulator based on the determined information.

13. Method for determining information relating to an adherence of a patient having a respiratory disorder using a device, comprising the steps of: measuring a value of a first flow parameter in a fluid channel of the device, said fluid channel being configured to be in fluid communication with a medical gas source at a first end and with a patient interface at a second end using a first sensor of a sensor arrangement of the device; measuring a value of a second flow parameter in said channel using a second sensor of said sensor arrangement; determining a flow direction of a medical gas in the channel using a control unit of the device based on the measured first flow parameter and second flow parameter communicated to said control unit; and determining the information using the control unit based on the determined flow direction, wherein the first sensor and the second sensor are spaced apart from each other along a longitudinal axis of the channel and are arranged at opposing ends of the channel, wherein the device is configured such that either end of the channel is configured to be coupled to a medical gas source or a patient interface, and further comprising the steps of indicating a coupling orientation of the device as part of the determined information and selecting, using the control unit, a particular sensor based on the coupling orientation and the relative position of the sensor to perform a measurement of a flow characteristic at a downstream end of the channel.

14. Method according to claim 13, further comprising the steps of: calculating a differential pressure from the measurements of the first sensor and the second sensor, wherein the first flow parameter and the second flow parameter are the same, or measuring a differential pressure, wherein one of the sensors is configured as a differential pressure sensor; and determining the flow direction based on the determined differential pressure, and preferably outputting a visual and/or an acoustic alarm based on the determined information.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The present disclosure and preferred embodiments will be more readily appreciated by reference to the following detailed description when being considered in connection with the accompanying drawings in which:

[0066] FIG. 1 is a schematic view of a device for determining an information related to a patient treatment with a sensor arrangement with a first and second sensor;

[0067] FIG. 2 is a schematic view of a device for determining an information related to a patient treatment with a sensor arrangement with a first and second sensor according to FIG. 1 with a differential pressure sensor;

[0068] FIG. 3 is a schematic view of a device for determining an information related to a patient treatment with a sensor arrangement with a first and second sensor according to FIG. 1 with a signaling device and identical couplings;

[0069] FIG. 4 is a schematic view of a device for determining an information related to a patient treatment with an evaluation unit and monitoring unit; and

[0070] FIG. 5 is a method for determining an information related to a patient treatment.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0071] In the following, the invention will be explained in more detail with reference to the accompanying figures. In the Figures, like elements are denoted by identical reference numerals and repeated description thereof may be omitted in order to avoid redundancies.

[0072] In FIG. 1 a device 1 for determining an information related to a patient treatment is schematically shown. Accordingly, the device 1 comprises a fluid channel 2, which extends along a longitudinal axis of the device and comprises a first end 20 and a second end 22, which may be coupled to corresponding connectors of a medical gas source and a patient interface, respectively. The channel 2 is configured and dimensioned to allow a medical gas to pass through the channel 2 from one end 20, 22 to a respective opposing end 22, 20, such that a minimal resistance is provided and a medical gas may be applied to a patient according to a prescribed dosage regimen.

[0073] Furthermore, a first sensor 30 and a second sensor 32 are arranged along the channel 2 and at respective ends 20, 22 of said channel. The first sensor 30 and the second sensor 32 are in fluid communication with the channel 2 and are configured to measure a flow parameter of a medical gas provided in said channel 2. Although the sensors 30, 32 of the sensor arrangement 3 may have various configurations, the first sensor 30 and the second sensor 32 according to the exemplary embodiment of FIG. 1 are configured as pressure sensors.

[0074] In addition, it is to be understood that the schematic depiction is merely provided by means of an example. For example, the sensors 30, 32 are depicted in an essentially symmetrical arrangement along a longitudinal axis of the device 1. However, the spacing between the first and second sensors 30, 32 may also be asymmetrical, such that at least one of the sensors 30, 32 may be arranged at a further or closer distance to the respective end 20, 22. In addition, the spacing along a longitudinal axis of the device is merely optional and is generally to be understood as a spacing in a direction of a fluid flow in the fluid channel 2 rather than a radial spacing with regard to the fluid channel 2.

[0075] In other words, the spacing may relate to a downstream and corresponding upstream arrangement of said sensors 30, 32, which may essentially correspond to a longitudinal axis of the device 1, as is the case in the embodiment shown in the schematic depiction of FIG. 1. Depending on the geometry of the fluid channel 2 and/or the device 1 said sensors 30, 32 hence do not need to be spaced apart in a uniaxial manner, but may optionally also be arranged e.g. in a curvature, such as at an end of a bent tube. Furthermore, the arrangement of the sensors 30, 32 may optionally also comprise a radial spacing or circumferential spacing along a wall of the fluid channel 2. Hence, a variety of sensor arrangements 3 is provided.

[0076] Both the first sensor 30 and the second sensor 32 are in communication with a control unit 4 provided in the device 1. The control unit 4 is hence configured to receive a measurement value of a measured pressure of a medical gas in the channel 2 from the first sensor 30 and the second sensor 32.

[0077] Since the first sensor 30 and the second sensor 32 of the device 1 are arranged at opposite ends 20, 22 of the channel 2, the sensors 30, 32 may be either in proximity of a medical gas source or a patient interface in a coupled state. Since the control unit 4 is provided with measurement values from each sensor 30, 32, it is required that the control unit 4 is capable of associating the respective measurement value with either an input measurement, i.e. a medical gas flow provided via e.g. a pressure regulator of a medical gas source, or an output measurement, i.e. a medical gas flow provided at a patient interface.

[0078] In order to facilitate such association, the control unit 4 calculates a virtual differential measurement by creating an artificial impedance in the channel 2 between the first sensor 30 and the second sensor 32, wherein the exact positions of the sensors 30, 32 and the characteristics of the channel are known. In a connected or coupled state, i.e. in a system with a medical gas source and a patient interface, the pressure measured at the sensor located nearest to the medical gas source, e.g. at a gas inlet, will be higher than the measured pressure at the other sensor, e.g. at a gas outlet, such that a flow direction may be determined based on the calculated differential pressure and/or the respective pressure at each of the sensors. Accordingly, the control unit 4 determines the flow direction based on a calculated differential pressure.

[0079] Based on said flow direction, the control unit 4 may then determine the information, which may e.g. indicate whether the device 1 is connected in the correct orientation. Said information may either be stored, e.g. for a later analysis and evaluation indicating that e.g. no adherence data could be determined for a specific time period, or may be used or retrieved directly.

[0080] An alternative determining of the flow direction is shown in the embodiment according to FIG. 2. Accordingly, again, the device 1 comprises the fluid channel 2 and the sensor arrangement 3, which is in communication with the control unit 4. In addition, a differential pressure sensor 34 is provided, which is arranged at the channel 2 along the longitudinal axis of the device 1 and between the first sensor 30 and second sensor 32.

[0081] The differential pressure sensor 34 comprises a membrane which represents a pneumatic impedance to the flow of gas in the channel 2. Accordingly, the differential pressure sensor 34 directly measures a pressure difference at two sides of the sensor 34 and accordingly provides a differential pressure having either a negative or a positive measurement value, depending on the flow direction with respect to the differential pressure sensor 34. The control unit 4 may then directly determine the flow direction based on said measurement value.

[0082] By means of the differential pressure sensor 34 the flow direction may be immediately determined and a calculation or comparison of measurement values of the first sensor 30 and the second sensor 32 is not required. Although the differential pressure sensor 34 is depicted to be arranged at a central position of the channel 2, the sensor 34 may also be arranged at a respective end 20, 22 of the channel 2. Accordingly, the device 1 may also be configured to comprise only one sensor 30, 32 configured to measure a flow characteristic at a respective other end 20, 22 of the channel 2.

[0083] Furthermore, the device 1 may not be compatible to measure a flow characteristic when the device 1 is not connected according to a predefined or desired orientation. To hence provide an alert to a user or patient, a corresponding signal may be provided via a signaling device 5, as shown in FIG. 3. The signaling device 5 is depicted as a display to visually indicate the orientation of the device 1. Accordingly, the patient is immediately provided with a feedback relating to the coupling of the device 1 to a corresponding medical gas source and/or patient interface.

[0084] In addition, the ends 20, 22 of the channel 2 are configured as identical couplings 24, such that the device 1 may be connected in either orientation. In other words, the outer industrial design is omnidirectional, i.e. it is intended that the user can connect the device 1 to the components of a treatment system, e.g. a gas output line of a medical gas source or pressure regulator, in any orientation.

[0085] As described in the above in view of FIG. 1, the control unit 4 determines the flow direction based on a calculated or virtual differential pressure and may then determine the information based on said flow direction. In particular, the information may furthermore comprise a measurement value provided by the respective sensors 30, 32, which may indicate the medical gas flow applied to the patient from the sensor at the upstream end, i.e. as seen from the determined flow direction in the channel 2, and e.g. a patient response to said gas flow by the measurement value of the sensor at the corresponding downstream end of the channel 2.

[0086] Such patient response may e.g. be provided as a measurement of a respiratory parameter, e.g. a breathing pattern or breathing variation, in particular, when the patient interface is provided with an on-demand valve and/or is configured as a nasal or face mask. By the same token, the measurement of the medical gas flow in the channel 2 may be used to measure the variation of flow caused by e.g. pressure regulator adjustments and/or a change of flow in the channel 2 caused by the respiratory effect of the patient. Accordingly, the information relating to the patient treatment may provide detailed information regarding the patient adherence.

[0087] Said information may be output in the signal provided at the display on the device, such that the patient or medical personnel not only is provided with a connection or coupling feedback but may also follow e.g. an adherence status. By the same token, this may provide a feedback as to a predefined target, e.g. a predefined time for the medical gas to be applied, which may be indicated with a corresponding timer on said display.

[0088] To provide even further information and a more detailed analysis of the measured or determined parameters, the device 1 may optionally comprise an evaluation unit 40 and/or a monitoring unit 7, as schematically shown in FIG. 4.

[0089] The evaluation unit 40 is in communication with the control unit 4 to receive the measurement parameters and/or the determined information from the control unit 4. From said received measurement values or data, the evaluation unit 40 is configured to determine a physiological parameter of the patient based on the measured respiratory parameter of the patient, such that the hence provided information may e.g. provide an exacerbation prediction of the patient.

[0090] Said prediction may e.g. be based on a breathing pattern or rhythm, an exhalation and/or inhalation time, a breathing volume, and/or a dynamic flow measurement, as measured by the sensor arranged at a downstream end of the fluid channel 2 determined by the differential pressure sensor 34. By the same token, a measurement from the sensor arranged at the corresponding opposite end of the channel may provide further information relating to the determined flow rate and/or the flow volume of the medical gas in the channel 2 and applied to the patient.

[0091] The control unit 4 and/or the evaluation unit 40 may be configured as e.g. a microcontroller or processor in the device 1 and may each comprise control logic to determine the information based on the received measurement values. Furthermore, although the control unit 4 and the evaluation unit 40 are depicted as separate components, they may also be combined in an integrated unit or device, which is either included in the device 1 or is arranged outside of the device 1 and communicates with the sensor arrangement 3 via a corresponding connection.

[0092] The device 1 furthermore comprises a monitoring unit 7, which is in communication with the control unit 4 and is configured to compare the determined information, the measured respiratory parameter, and/or the determined physiological parameter with a corresponding threshold or control logic stored in the monitoring unit 7. For example, the monitoring unit 7 may detect when a predefined threshold of a measured or determined parameter is exceeded by comparing the values with a corresponding list of values.

[0093] Furthermore, the monitoring unit 7 may be used to simply detect whether the device 1 is connected or coupled in the correct orientation or direction based on an output of the differential pressure sensor 34, i.e. by detecting whether the detected differential pressure is positive or negative.

[0094] Accordingly, the monitoring unit 7, which may also be integrated or combined with the evaluation unit 40 and/or the control unit 4, may provide either a feedback relating to the orientation of the device 1 and/or may provide detailed information relating to the patient treatment. In either case, the device may output a signal or alert via a signaling device 5, which is here depicted as an alarm generating unit or acoustic device. However, the signaling device may also be configured to output a visual alert, e.g. in the form of an LED.

[0095] In addition, the device 1 comprises a communication device 6, which enables a communication between the device 1 and an external device (not shown). Accordingly, the communication device 6 may communicate a signal or information provided by or via the control unit 4, as indicated by the dashed arrow. For example, should the evaluation unit 40 determine e.g. an adherence information or other information of the patient and/or the monitoring unit 7 detects that a device parameter, e.g. a pressure in the channel 2, is exceeded beyond tolerable levels, the control unit 4 may provide an information and/or alarm signal to an external device, e.g. a remote screen, a mobile device, or computer. Accordingly, medical personnel may perform an assessment of said information and/or alarm signal and may accordingly assess the treatment course and/or intervene, if necessary.

[0096] The information that is communicated via the communication device 6 may also be transmitted to be accordingly stored in an external database or cloud, such that the information may be retrieved at any other time point and at a remote location. As such, a data entry history may be provided, which facilitates a more detailed assessment of the treatment course of the patient, e.g. to accordingly provide modifications.

[0097] FIG. 5 schematically shows a corresponding method 100 for determining an information related to a patient treatment. Said method 100 may e.g. be performed by the device 1 as described in the above, such that the method may comprise various other features and other functions. The method 100 comprises the step of measuring a value of a first flow parameter (S110) in a fluid channel configured to be in fluid communication with a medical gas source at a first end and with a patient interface at a second end using a first sensor of a sensor arrangement and measuring a value of a second flow parameter (S120) in said channel using a second sensor of said sensor arrangement at a position spaced apart from the first sensor along a longitudinal axis of the channel.

[0098] The channel may be any fluid channel that allows a fluid communication between either end of the channel, such that the channel may be coupled to a system for applying a medical gas to a patient without significantly reducing a gas flow or providing an additional resistance for said gas flow. Preferably, the measurements are performed within a connecting line or tube coupled between the medical gas source and a patient interface.

[0099] Based on the measured value of the first flow parameter and the second flow parameter, the method 100 then determines a flow direction of a medical gas in the channel using a control unit (S130). As described in the above, the flow direction may e.g. be determined by a differential pressure measurement performed by a differential pressure sensor or by measuring both measurement values measured by the sensors, e.g. configured as pressure sensors, and calculating a virtual differential pressure between said sensors. Based on the determined differential pressure the control unit may then determine the flow direction of the device.

[0100] From said determined flow direction, the information is then determined in a further step (S140). Accordingly, the method may provide that an information is determined indicating that no adherence data may be determined, e.g. when the device is not connected properly and/or no predefined gas flow is detected. Preferably, the determined information indicates whether the device 1 is connected in the correct orientation (S150). Said information may either be stored, e.g. for a later analysis and evaluation indicating that e.g. no adherence data could be determined for a specific time period, or may be used or retrieved directly, e.g. to output a corresponding signal.

[0101] It will be obvious for a person skilled in the art that these embodiments and items only depict examples of a plurality of possibilities. Hence, the embodiments shown here should not be understood to form a limitation of these features and configurations. Any possible combination and configuration of the described features can be chosen according to the scope of the invention.

LIST OF REFERENCE NUMERALS

[0102] 1 Device for determining an information [0103] 100 Method for determining an information [0104] 2 Fluid channel [0105] 20 First end [0106] 22 Second end [0107] 24 Coupling [0108] 3 Sensor arrangement [0109] 30 First sensor [0110] 32 Second sensor [0111] 34 Differential pressure sensor [0112] 4 Control unit [0113] 40 Evaluation unit [0114] 5 Signaling device [0115] 6 Communication device [0116] 7 Monitoring unit [0117] S110 Measuring a value of a first flow parameter [0118] S120 Measuring a value of a second flow parameter [0119] S130 Determining a flow direction [0120] S140 Determining the information [0121] S150 Indicating a coupling orientation of the device