Systems and methods for identifying patient interface device using mask cleaning system

Abstract

A system and method for identifying a patient interface device to be used in a pressure support system using a mask cleaning system constructed and configured to clean the patient interface device, the mask cleaning system having a controller. The controller is configured to evaluate outputs from the plurality of sensors and operational parameters of the plurality of connected components within the mask cleaning system. The evaluation enables the controller to obtain operating parameters and values of the sensor and further identify a mask coupled to the mask cleaning system. If the operating parameters indicate that an incorrect mask is coupled to the mask cleaning system, the user may be alerted.

Description

[0001] Cross - Reference to Related Applications

[0002] This patent application claims the benefit of priority of U.S. Provisional Application No. 63 / 434,493, filed on Dec. 22, 2022, under 35 U.S.C. § 119(e), the content of which is incorporated herein by reference. Technical Field

[0003] The disclosed concepts generally relate to mask cleaning systems, and more particularly to systems and methods for identifying detected changes in a patient interface device and warning a user such that appropriate changes to cleaning settings can be made. Background Art

[0004] Today, the first-line treatment for patients diagnosed with obstructive sleep apnea syndrome (OSAS) after a sleep test is pressure-assisted ventilation support, most commonly continuous positive airway pressure (CPAP) therapy. Treatment is reimbursed in moderate and severe patients with an AHI > 15. In mild OSA patients with daytime symptoms or with chronic and persistent cardiac comorbidities, PAP therapy is reimbursable for an AHI > 5. Reimbursement covers the PAP device as well as the periodic resupply of consumable items such as tubing, headgear, masks, and cushions. Additionally, patients may choose to purchase accessories such as mask cleaning or disinfection systems. Several different mask cleaning systems can be used, such as ozone-based disinfectants and UV light disinfectants. Alternative consumer mask cleaning systems using cleaners, heated fluids, or steam are also possible.

[0005] Proper setup of the PAP device, including for example pressure settings and mask fitting, is done by a qualified sleep clinician, most commonly in an overnight setup in a sleep laboratory. However, home titration is a possible alternative for some patients.

[0006] Once the correct machine settings and appropriate consumable items are established, the device is provided by a durable medical equipment (DME) supplier and the patient begins treatment. In the event of difficulty with any aspect of the treatment, consultation can be had, optionally followed by retitration, which can result in a change in mask type. For example, a patient may switch from a nasal mask to an oro-nasal mask or a full face mask. This change must be communicated to the DME, who then provides the patient with a new mask.

[0007] In addition, patients can also purchase masks out of pocket. For example, if the mask is lost or damaged during the reimbursement period, or if the patient believes they need a mask different from the one recommended by the clinician. In either of these situations, the patient may end up using a mask different from the one specified by the clinician for their treatment, potentially resulting in a mismatch between the mask used and the specified mask. This mismatch can have a significant impact on treatment because the PAP machine settings are no longer matched to the mask used by the patient. SUMMARY OF THE INVENTION

[0008] These and other needs are met by a system and method for identifying a patient interface device that can be used in a pressure support system using a mask cleaning system. The mask cleaning system can have a controller and can be constructed and configured to clean the patient interface device. The method can include the steps of: (a) operating the mask cleaning system during a cleaning period to clean the patient interface device, (b) obtaining in the controller one or both of: (i) a value for each of a plurality of operating parameters of the mask cleaning system for the cleaning period, and (ii) a sensor measurement for each of a plurality of sensors of the mask cleaning system for the cleaning period, and (c) determining in the controller an identity of the patient interface device or a suspected change in the patient interface device by one or both of: (i) comparing the value of each of the plurality of operating parameters to operating parameter data stored by the controller, and (ii) comparing the sensor measurement of each of the plurality of sensors to sensor data stored by the controller. In various embodiments, the plurality of sensors can include one or more of: a pressure sensor, a flow sensor, a temperature sensor, a force sensor, a level sensor, a capacitance sensor, and a magnetic sensor.

[0009] Another aspect of the disclosed concepts may also include a mask cleaning system configured and arranged to clean a patient interface device for use in a pressure support system. The mask cleaning system may include a main chamber holding device and a controller for holding the patient interface device during operation of the mask cleaning system for a cleaning period to clean the patient interface device. The controller may be configured and arranged for (a) obtaining one or both of: (i) values of each of a plurality of operating parameters of the mask cleaning system for the cleaning period, and (ii) sensor measurements of each of a plurality of sensors of the mask cleaning system for the cleaning period; and (b) determining an identity or suspected change of the patient interface device by one or both of: (i) comparing the value of each of the plurality of operating parameters with operating parameter data stored by the controller, and (ii) comparing the sensor measurement of each of the plurality of sensors with sensor data stored by the controller. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] A full understanding of the present invention can be obtained from the following description of the preferred embodiments, when read in conjunction with the accompanying drawings, in which:

[0011] Figure 1 is a schematic diagram showing a system for identifying a change in a patient interface device when the patient interface device is coupled to a main chamber in an ozone pump mask cleaning system according to an exemplary embodiment of the disclosed concepts, the change in the patient interface device including an initial identification at first use;

[0012] Figure 2 is a schematic diagram showing a system for identifying a change in a patient interface device in a mask cleaning system while the patient interface device is held within a main chamber holding device including an integrated capacitance sensor, the change in the patient interface device including an initial identification at first use;

[0013] Figure 3 is a schematic diagram showing a system for identifying a change in a patient interface device in a mask cleaning system while the patient interface device is magnetically coupled to a holding device, the change in the patient interface device including an initial identification at first use, the holding device including a resistance sensor integrated therein; and

[0014] Figure 4 is a flow chart showing an overall method according to an exemplary embodiment of the disclosed concepts. DETAILED DESCRIPTION

[0015] As used herein, the terms "cleaning period" and "cleaning operation" refer to the processes performed by a mask cleaning system to remove chemicals, biological materials, debris, and other unwanted contaminants from a mask and / or associated components or systems (such as a CPAP device).

[0016] As used herein, the term "cleaning" refers to activities that reduce, remove, disinfect, passivate, or otherwise minimize the presence of unwanted elements within or around a mask and / or associated components and / or systems.

[0017] As used herein, the term "operating parameter" shall refer to a parameter that describes and / or determines the functionality of a mask cleaning system and / or a subsystem of one or more components within the mask cleaning system. For example, the length of time for which the mask cleaning system is required to reduce contaminants by 10% can be an operating parameter. Similarly, the amount of energy required to increase the temperature of a patient interface device by 5 degrees can be an operating parameter. Other operating parameters can include run time, pump settings, power consumption, temperature, light intensity, and cleaning fluid type. Additionally, an operating parameter can also refer to a relative value with respect to a baseline (e.g., before or after a cleaning period).

[0018] As used herein, the term "communicatively coupled" will mean that two or more electrical components are connected in such a way that power, information, or both can be exchanged between the coupled components.

[0019] As used herein, the term "operatively coupled" will mean that two or more components are functionally connected either directly or through one or more intermediate components such that a shift, manipulation, or actuation of any of the coupled components causes a predefined response in the remaining components.

[0020] As used herein, "number" means a number that is one or greater than one (i.e., a plurality).

[0021] The disclosed concepts relate to systems and methods for identifying a patient interface device using a mask cleaning system that is constructed and configured to clean the patient interface device. More specifically, in various particular embodiments described herein, the disclosed concepts provide a mask cleaning system in which a change in the connected patient interface device can be identified by the system based on at least one of a plurality of operating parameters and / or the output of a plurality of sensors set by the mask cleaning system.

[0022] Figure 1FIG. 0 is a schematic view of a face mask cleaning system 1 according to an exemplary embodiment of the disclosed concept, the face mask cleaning system 1 being adapted to clean a patient interface device 2 using an ozone gas stream generated by the face mask cleaning system 1. The patient interface device 2 in the illustrated exemplary embodiment includes a full-face mask type mask component. However, it should be understood that this is merely exemplary and other types of mask components may be envisioned within the scope of the disclosed concept.

[0023] As Figure 1 shown, the face mask cleaning system 1 includes a holding device in the form of a main chamber 4 for holding the patient interface device 2 during the cleaning process. The face mask cleaning system 1 further includes a pump 6 positioned within the main chamber 4. The pump 6 is constructed and configured to generate an ozone stream for use in the cleaning process described herein. Additionally, the face mask cleaning system 1 further includes a plurality of sensors 3 (e.g., including a flow sensor as shown) for measuring various types of data related to the operation of the face mask cleaning system 1, such as but not limited to flow rate, pressure, or temperature. The face mask cleaning system 1 further includes a holding device (e.g., in the form of a hose as shown), a controller 5, and a pump 6. The controller 5 is constructed and configured to control the operation of the face mask cleaning system 1 as described herein. The controller 5 forming part of the face mask cleaning system 1 may be, for example, a microprocessor, a microcontroller, or some other suitable processing device that includes or is operably coupled to a memory that provides a storage medium for data and software executable by the controller 5 for controlling the operation of the face mask cleaning system 1. The controller 5 is communicatively coupled to each of the plurality of sensors 3 for receiving data generated by each sensor 3. Additionally, the controller 5 is constructed and configured to monitor various operating parameters of the face mask cleaning system 1, such as but not limited to run time, pump settings, power consumption, and / or temperature. Finally, as Figure 1 shown, the face mask cleaning system 1 may also be coupled to an external system 7 in the form of an airway pressure support system, such as a CPAP device.

[0024] In operation, the patient interface device 2 is inserted into the main chamber 4 and the face mask cleaning system 1 is coupled to the external system 7 through a suitable mechanism such as a fluid conduit. The pump 6 is then activated and an ozone stream is started to be generated within the main chamber 4. The ozone stream within the main chamber 4 is then provided to various inner and outer surfaces of the patient interface device 2 in order to clean these surfaces. Additionally, a portion of the ozone stream is also provided through an associated conduit (i.e., the CPAP device in the illustrated embodiment) to the external system 7 (i.e., the CPAP device in the illustrated embodiment) in order to clean its various inner surfaces, such as the interior of a humidifier forming part of the external system 7. As a result, the face mask cleaning system is capable of effectively cleaning the patient interface device 2 and / or the external system 7.

[0025] In addition, according to another aspect of the disclosed concept, the controller 5 is constructed and configured to determine whether a user has changed the patient interface device 2 coupled to the mask cleaning system 1 since the previous use of the mask cleaning system 1, including the initial identification at the first use. More specifically, the controller 5 is constructed and configured to obtain one or both of the following: (i) the value of each of the plurality of operating parameters of the mask cleaning system 1 for a particular cleaning period, and (ii) the sensor measurements of each of the plurality of sensors 3 for the cleaning period. The controller 5 is also constructed and configured to determine the identity or suspected change of the patient interface device by one or both of the following: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored by the controller 5 (e.g., in the form of mask profile information), and (ii) comparing the sensor measurements of each of the plurality of sensors 3 with the sensor data stored by the controller 3 (e.g., in the form of mask profile information). In other words, the current operating parameters of the system determined in the controller 5 and / or the output from the plurality of sensors 3 are used to form a current mask profile, which can then be compared with one or more stored mask profiles to determine the identity of the patient interface device 2 or a suspected change in the patient interface device 2 used with the mask cleaning system 1. In a non-limiting embodiment, the current mask profile is automatically generated during a first cleaning period in which the patient interface device 2 is cleaned by the mask cleaning system 1. The initial cleaning period can be used as a diagnostic cycle for determining the mask type and baseline operating parameters.

[0026] Figure 2 is similar to Figure 1 FIG. 1' is a schematic diagram of a mask cleaning system 1' that is similar to the mask cleaning system 1 shown, and the same components are labeled with the same reference numerals. The mask cleaning system 1' can employ any one of a variety of different cleaning methods / mechanisms, such as but not limited to the ozone stream, UV light, cleaning agent / cleaning fluid, or steam described above. However, in this embodiment, the chamber 4 of the mask cleaning system 1' is provided with a capacitance sensor 3 integrated therein. The chamber 4 serves as a holding device into which the patient interface device 2 is inserted during the cleaning period. The capacitance sensor 3 can be disposed at the bottom of the chamber 4 or other suitable locations, such as within the sidewall or top cover, and is used to detect the presence and / or identity of the patient interface device 2 or a change in the patient interface device 2 based on the level or degree of disruption of the fringe electromagnetic field provided within the chamber 4. In particular, the sensor data from the capacitance sensor 3 can be compared with a look-up table of capacitance sensor values for known masks. The identity of the patient interface device 2 can be determined as the patient interface device 2 having the closest known capacitance sensor value. This embodiment is operationally similar to Figure 1The operation of the face mask cleaning system 1 as shown and described herein, because after the cleaning operation has been performed, the identity or suspected change of the patient interface device 2 can be detected by performing one or both of the following operations: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored by the controller 5, and (ii) comparing the sensor measurements of the capacitance sensor 3 with the sensor data stored by the controller.

[0027] Figure 3 is similar to Figure 1 FIG. is a schematic view of a face mask cleaning system 1" similar to the face mask cleaning system 1 shown and described herein, and like parts are labeled with like reference numerals. The face mask cleaning system 1" can employ any of a variety of different cleaning methods / mechanisms, such as, but not limited to, an ozone stream, UV light, a cleaning agent / cleaning fluid, or steam as described above. However, in this embodiment, the chamber 4 includes a primary magnetic coupling device (e.g., a snap connector) that can mate with a corresponding magnetic coupling device (e.g., a snap connector) on the patient interface device 2 during a cleaning period. In an alternative non-limiting embodiment, the chamber 4 includes at least one mounting fixture (e.g., including a mechanical connector) that holds the patient interface device 2 in a desired orientation. Additionally, the mounting fixture enables the patient interface device 2 to be fluidly and communicatively coupled to the controller 5 and the face mask cleaning system 1 such that the mounting fixture provides an additional interface through which the characteristics of the face mask 2 (e.g., operating parameters and sensor data) are measured. The advantage of connecting the patient interface device 2 in this manner is that the patient interface device 2 will be correctly positioned within the chamber 4 and positioned in the same manner for each cleaning period or cycle.

[0028] In this embodiment, the plurality of sensors 3 includes a resistance sensor 3 integrated into the primary magnetic coupling device. The resistance sensor 3 facilitates the identification of the patient interface device 2 by enabling the controller 5 to compare the current resistance profile of the patient interface device 2 with a stored resistance profile. In another non-limiting embodiment, the plurality of sensors 3 can be integrated into the mounting fixture and the plurality of sensors 3 can include one or more of the following: a magnetometer, a strain sensor, a resistance sensor, a capacitance sensor, a pressure sensor, an optical sensor, an inductance sensor, a radio frequency identification (RFID) transceiver, and a proximity sensor. This embodiment is similar in operation to Figure 1 the operation of the face mask cleaning system 1 as shown and described herein, because after the cleaning operation has been performed, the identity or suspected change of the patient interface device 2 can be detected by performing one or both of the following operations: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored by the controller 5, and (ii) comparing the sensor measurements of the resistance sensor 3 with the sensor data stored by the controller.

[0029] Figure 4 is a flowchart showing a method of identifying a patient interface device after cleaning the patient interface device using a face mask cleaning system according to an exemplary embodiment of the disclosed concept. For illustrative purposes, the method will be described in connection with face mask cleaning system embodiments 1, 1' and 1" discussed above, but it will be understood that this is merely meant to be exemplary. Additionally, in the exemplary embodiment, Figure 4 the method is implemented in one or more software routines that are stored and executed by a controller 5 forming part of the face mask cleaning system 1, 1' or 1".

[0030] Referring to Figure 4 , the method of the disclosed concept begins at step 100 by operating the face mask cleaning system 1 for a cleaning period to clean the patient interface device 2. The method continues at step 102 by obtaining in the controller 5 one or both of: (i) the value of each of a plurality of operating parameters of the face mask cleaning system 1 for the cleaning period, and (ii) the sensor measurements of each of a plurality of sensors 3 of the face mask cleaning system 1 for the cleaning period. In a non-limiting embodiment, the controller 5 may maintain relative measurements of the operating parameters or sensor measurements. For example, a level sensor first measures a level when the face mask 2 has not been inserted into the chamber 4 and then measures the level when the face mask 2 is inserted into the chamber 4. Thus, the operating parameter related to fluid displacement is a relative value proportional to the volume of the face mask 2. In another non-limiting embodiment, the capacitance sensor 3 from Figure 2 increases face mask ID accuracy by collecting a baseline measurement (i.e., empty cleaner) value before inserting the face mask 2.

[0031] The method continues at step 104 by determining the identity or suspected change of the patient interface device 2 in the controller 5 by doing one or both of the following: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored in the controller 5, and (ii) comparing the sensor measurement of each of the plurality of sensors 3 with the sensor data stored in the controller 5. When determining the identity of the patient interface device 2 currently attached to the mask cleaning system 1, the controller 5 can analyze a plurality of data points. In addition, the operating parameter data stored by the controller 5 and the sensor data stored by the controller 5 can be organized by the controller 5 into a plurality of stored profiles. The controller 5 can compare the current mask profile or identity with at least one of the plurality of stored profiles to determine whether the current mask profile matches the mask profile of a previous patient interface device 2 coupled to or inserted into the main chamber 4. In one embodiment, if the current mask profile does not match the mask profile of the previous patient interface device 2, the controller 5 generates an alert. The alert can be sent to at least one of the following: the user, the user device, the care provider, the relevant third party, the DME, and the external system 7.

[0032] In one embodiment, when comparing the current mask profile and the stored profiles, the controller 5 can identify the matching profile from the plurality of stored profiles. The matching profile can be designated as a mask identifier (ID). In addition, the controller 5 can modify the operating parameters of the mask cleaning system 1 to prevent damage to the patient interface device 2 during subsequent cleaning periods or to better clean the patient interface device 2.

[0033] In a particular non - limiting exemplary embodiment, 102 can include obtaining both: (i) the value of each of the plurality of operating parameters of the mask cleaning system 1 for a cleaning period, and (ii) the sensor measurement of each of the plurality of sensors 3 of the mask cleaning system 1 for the cleaning period. In addition, step 104 in this exemplary embodiment can include determining the identity or suspected change of the patient interface device 2 by both: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored in the controller 5, and (ii) comparing the sensor measurement of each of the plurality of sensors 3 with the sensor data stored in the controller 5.

[0034] When the difference between the current operating parameters and the stored operating parameters exceeds a predetermined threshold, the controller 5 can use this data to determine an appropriate course of action. The plurality of operating parameters can include the operating time of the face mask cleaning system 1 during a cleaning period. The plurality of operating parameters can also include the power consumption level of the face mask cleaning system 1 during a cleaning period. The plurality of operating parameters can also include the fluid pressure level or the fluid flow rate level of the face mask cleaning system 1 during a cleaning period. The plurality of operating parameters can also include the temperature level of the face mask cleaning system 1 during a cleaning period. The plurality of operating parameters can also include the heat used by the face mask cleaning system 1 during a cleaning period. The plurality of operating parameters can also include a plurality of operating settings for the face mask cleaning system 1 during a cleaning period.

[0035] It is contemplated that aspects of the disclosed concepts can be embodied as computer-readable code on a tangible computer-readable recording medium. A computer-readable recording medium is any data storage device that can store data that can later be read by a computer system. Examples of computer-readable recording media include read-only memory (ROM), random access memory (RAM), CD-ROMs, magnetic tapes, floppy disks, and optical data storage devices.

[0036] While particular embodiments of the invention have been described in detail, those skilled in the art will understand that various modifications and substitutions can be made to these details in accordance with the general teachings of the disclosure. Accordingly, the particular arrangements disclosed are illustrative only and do not limit the scope of the disclosed concepts, the scope of which is given by the full breadth of the appended claims and any and all equivalents thereof.

Claims

1. A method of identifying a patient interface device to be used in a pressure support system, the pressure support system using a mask cleaning system configured and arranged to clean the patient interface device, the mask cleaning system having a controller, the method comprising: (a) operating the mask cleaning system during a cleaning period to clean the patient interface device; (b) obtaining in the controller one or both of: (i) a value of each of a plurality of operating parameters of the mask cleaning system for the cleaning period, and (ii) a sensor measurement of each of a plurality of sensors of the mask cleaning system for the cleaning period; and (c) determining an identity or a suspected change of the patient interface device in the controller by one or both of: (i) comparing the value of each of the plurality of operating parameters with operating parameter data stored by the controller, and (ii) comparing the sensor measurement of each of the plurality of sensors with sensor data stored by the controller.

2. The method according to claim 1, wherein the plurality of operating parameters includes an operating time of the mask cleaning system for the cleaning period.

3. The method according to claim 1, wherein the plurality of operating parameters includes a power consumption level of the mask cleaning system for the cleaning period.

4. The method according to claim 1, wherein the plurality of operating parameters includes a fluid pressure level or a fluid flow rate level for the mask cleaning system for the cleaning period.

5. The method according to claim 1, wherein the plurality of operating parameters includes a temperature level of the mask cleaning system for the cleaning period.

6. The method according to claim 1, wherein the plurality of operating parameters includes heat used by the mask cleaning system during the cleaning period.

7. The method according to claim 1, wherein the plurality of operating parameters includes a plurality of operating settings of the mask cleaning system for the cleaning period.

8. The method according to claim 1, wherein the plurality of sensors includes one or more of: a pressure sensor, a flow sensor, a temperature sensor, a force sensor, a level sensor, a capacitance sensor, and a magnetic sensor.

9. The method according to claim 1, wherein (b) comprises obtaining both: (i) the value of each of the plurality of operating parameters of the face mask cleaning system for the cleaning time period, and (ii) the sensor measurement of each of the plurality of sensors of the face mask cleaning system for the cleaning time period, and wherein (c) comprises determining the identity or suspected change of the patient interface device by both: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored by the controller, and (ii) comparing the sensor measurement of each of the plurality of sensors with the sensor data stored by the controller.

10. A face mask cleaning system configured and arranged to clean a patient interface device for use in a pressure support system, the face mask cleaning system comprising: a main chamber for operating the face mask cleaning system during a cleaning time period to clean the patient interface device while holding the patient interface device; and a controller configured and arranged for: (a) obtaining one or both of: (i) the value of each of the plurality of operating parameters of the face mask cleaning system for the cleaning time period, and (ii) the sensor measurement of each of the plurality of sensors of the face mask cleaning system for the cleaning time period; and (b) determining the identity or suspected change of the patient interface device by one or both of: (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored by the controller, and (ii) comparing the sensor measurement of each of the plurality of sensors with the sensor data stored by the controller.

11. The face mask cleaning system according to claim 10, wherein the plurality of operating parameters includes the operating time of the face mask cleaning system for the cleaning time period.

12. The face mask cleaning system according to claim 10, wherein the plurality of operating parameters includes the power consumption level of the face mask cleaning system for the cleaning time period.

13. The face mask cleaning system according to claim 10, wherein the plurality of operating parameters includes the fluid pressure level or the fluid flow rate level of the face mask cleaning system for the cleaning time period.

14. The face mask cleaning system according to claim 10, wherein the plurality of operating parameters includes the temperature level of the face mask cleaning system for the cleaning time period.

15. The face mask cleaning system according to claim 10, wherein the plurality of operating parameters includes the heat used by the face mask cleaning system during the cleaning time period.

16. The face mask cleaning system according to claim 10, wherein the plurality of operating parameters includes the plurality of operating settings of the face mask cleaning system for the cleaning time period.

17. The face mask cleaning system according to claim 10, wherein the plurality of sensors includes one or more of the following: a pressure sensor, a flow sensor, a temperature sensor, a force sensor, a liquid level sensor, a resistance sensor, a capacitance sensor, and a magnetic sensor.

18. The face mask cleaning system according to claim 10, wherein (a) includes obtaining both (i) the value of each of the plurality of operating parameters of the face mask cleaning system for the cleaning time period, and (ii) the sensor measurements of each of the plurality of sensors of the face mask cleaning system for the cleaning time period, and wherein (b) includes determining the identity or the suspected change of the patient interface device by both (i) comparing the value of each of the plurality of operating parameters with the operating parameter data stored by the controller, and (ii) comparing the sensor measurements of each of the plurality of sensors with the sensor data stored by the controller.

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