NZ765032B2 - Flow Generator Message System - Google Patents

Abstract

flow generator (10) for delivering breathable gas to a patient includes a processor (18) coupled with operation sensors (34) and a user interface (20). The processor is configured to: determine an apnea-hypopnea index (AHI) for the patient based on the signals of the at least one operation sensor; generate a message based on the AHI; and send the message to a recipient that is remote from the flow generator. generate a message based on the AHI; and send the message to a recipient that is remote from the flow generator.

Description

TITLE OF THE INVENTION FLOW GENERATOR MESSAGE SYSTEM CROSS-REFERENCES TO RELATED APPLICATIONS This application claims the benefit ofUS. Provisional Application No. 60/726,178, filed October 14, 2005, incorporated herein by reference in its entirety.

ENT REGARDING FEDERALLY RED RESEARCH OR DEVELOPMENT 10002] (NOT APPLICABLE) BACKGROUND OF THE INVENTION The present invention relates generally to flow generators for ventilatory assistance and, more particularly, to a flow generator thatincludes a message system for communicating es relating to flow tor operation, flow generator service, flow generator use, patient health, peripheral devices and services, patient treatments, general reminders, and the like. Messages may be delivered to an onboard. display or extemally to a service provider, the patient, a physician, or the like.

Non-Invasive Positive Pressure Ventilation (NIPPV) is a form of treatment for breathing disorders which can involve providing a relatively higher pressure of air or other breathable gas to the entrance of a patient's s via a patient interface (e.g., a mask) during the inspiratory phase of ation, and ing a relatively lower pressure or atmospheric pressure in the patient mask during the expiratory phase of respiration. In other NIPPV modes the pressure can be made to vary in a complex manner throughout the respiratory cycle. For example, the pressure at the mask during inspiration or expiration can be varied through the period of treatment.

WO 41797 Continuous Positive Airway Pressure (CPAP) treatment is commonly used to treat breathing disorders including Obstructive Sleep Apnea (OSA). CPAP treatment continuously provides pressurized air or other breathable gas to the entrance of a patient's airways via a patient interface (e. g., a mask) at a pressure elevated above atmospheric pressure, typically in the range 3-20 cm H20. CPAP ent can act as a pneumatic splint of a patient's upper airway.

CPAP ent can be in a number of forms, including the maintenance of a constant treatment pressure level, alternating between two different constant levels in synchronism with the inspiratory and expiratory phases of respiration ("bi-level , and having an automatically adjustable and/or a computer controlled level in accordance with a patient's therapeutic needs.

Breathable gas supply apparatus used in CPAP and NIPPV treatments broadly comprise a flow generator constituted by a continuous source of air or other breathable gas generally in the form of a blower driven by an electric motor. A rized supply of air or other able gas can also be used. The gas supply is connected to a conduit or tube, which is in turn connected to a patient interface (mask or nasal prong) which orates, or has in close proximity, a vent to atmosphere for exhausting exhaled gases, such as carbon e.

BRIEF SUMMARY OF THE INVENTION ' Patients using flow generators necessarily integrate the devices into their sleeping routine. The devices are used on a daily basis and greatly enhance the quality of life for patients requiring them. It would thus be desirable if the flow generators themselves could communicate with the users to maximize system effectiveness and therapy and facilitate use of the device in the ts’ daily lives.

In this context, it is iinportant that the device function and be operated properly, and it is desirable to enable the device to introspectively determine operating concerns or malfunctions. The present invention provides a flow tor that tes messages .to tate use of the device. The messages may relate to aspects of the flow generator itself or to. ating the system into a patient’s daily routine. The messages can be delivered over any suitable medium in any suitable manner, such as for example by written, graphical or audible‘messages. A related flow generator with a patient reminder system is disclosed in U.S. Patent Application Serial No. 10/533,940, the contents of which are hereby incorporated by reference.

In an exemplary embodiment of the invention, a flow generator for ring breathable gas to a patient includes a sor coupled with ion sensors and a user interface. The processor is programmed to generate one of time-based messages, event—based messages, or both time- and event-based messages relating to at least one of flow tor operation, flow generator service, flow generator use, patient health, peripheral devices and services, patient ent, and general reminders. The time-based messages are generated at predetermined time intervals based on either time ofuse or elapsed time, and the event—based messages are generated based on signals from the operation sensors. The user interface is configured to deliver the messages to at least one of a display, a flow tor e provider, the patient and a physician.

The processor is preferably programmed to receive a reminder request input, wherein the time-based messages include reminders generated at a time specified in the reminder request input. The user interface may include a wireless communication system that icates with at least one of a preset telephone , a cellular phone, a pager, and a call center.

In one embodiment, theuser ace is a k interface that. delivers the messages via a global network such as the intemet. In this context, the event-based messages may cemprise messages ng to flow generator parts requiring replacement or repair. er, the system may automatically order at least one of the parts requiring replacement or service for the repair. The network interface is preferably also configured to receive message content Viathe global k. The message content may » comprise information relating to new products and peripherals cooperatively usable with the flow generator.

The flow tor may additionally include a memory that stores software executed by the processor and data ng to flow generator use and ion.

The processor executes the software to generate the messages. In one embodiment, the memory is a data card.

The flow generator may still additionally include peripheral devices providing enhanced onality. The eral devices communicate with the processor, wherein the time-based and event-based messages relate to use and operation of the peripheral devices.

The time-based messages may be customizable, for example, providing a personal reminder for the patient, a wake-up alarm or the like. The wake—up alarm may be an audio message or may be effected via the delivery of breathable gas to the t.

The messages may e advertisements generated at predetermined time als and/or upon the occurrence of at least one event relating to flow generator use and operation. The es may relate to helpful user tips and may be ctive with the patient.

The event-based messages may be structured as notice levels relating to flow generator operation, Where the notice levels are changed based on a use condition duration detected by the sensors. In one ment, the use condition is a leak, wherein a first notice level provides an indication that the leak has been detected, a second notice level provides another indication that the leak has been detected along with user tips to correct the leak, and a third notice level provides a communication notifying a service provider or physician of the leak.

In another exemplary embodiment of the ion, a CPAP apparatus includes a flow generator that generates a supply of pressurized air to be provided at an outlet; a patient interface able with a patient's face to provide a seal; and an air delivery conduit coupled between the flow generator and the patient interface to deliver the supply ofpressurized air from the flow generator to the patient interface. The flow generator preferably includes a processor coupled with operation sensors and a user or communication interface.

In yet another exemplary embodiment of the invention, an identifier is provided for use with a flow generator that generates a supply of pressurized air to be provided at an outlet to a patient for treatment. The flow tor includes a proceSsor coupled with operation sensors and a user interface, wherein the sor is programmed to generate time—based and/or event-based messages relating to at least one of flow generator ion, flow tor service, flow generator use, patient health, peripheral devices and services, patient treatment, and general reminders, wherein the time-based messages are generated at predetermined time intervals based on either time ofuse or elapsed time, and n the event-based messages are generated based on s from the operation sensors. The identifier includes an identifying element providing an identifying feature unique to a specific peripheral component attachable to the flow generator. The processor discems the specific peripheral component via the identifying feature. In this context, the time-based and event-based messages are generated based on use and operation of the specific peripheral component.

In still another exemplary embodiment of the invention, a method is provided for operating a flow generator that tes a supply ofpressurized air to be provided at an outlet toaa patient for treatment, the flow generator including a processor coupled with operation sensors and a user interface. The method includes the steps of generating either time-based or event—based messages relating to at least one of flow generator operation, flow generator e, flow tor use, patient health, peripheral devices and services, patient treatment, and general reminders, the time-based messages being ted at predetermined time intervals based on either time ofuse or elapsed 1 time, and the event-based messages being generated based on signals from the operation sensors; and delivering the messages via the user interface to at least one of a y, a flow generator service provider, the patient and a ian.

BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects and advantages of the present invention Will be described in detail with reference to the accompanying drawings, in which: FIGURE 1 is a perspective view of an exemplary flow generator; and FIGURE 2 is a tic block diagram ofthe flow tor operating system and message/alarm functionality.

,~ DETAILED DESCRIPTION OF PREFERRED MENTS Flow Generator The concepts of the present invention are le for any flow generator providing NIPPV and/or CPAP treatment, including but not limited to flow generators having motor controlled pressure regulation or valve pressure regulation. An exemplary ’ flow generator structure will be described with reference to for purposes of explanation.

A flow generator 10 includes a motor 12 that provides a supply of pressurized air for the administration ofNIPPV and/or CPAP treatment. The pressurized air is delivered to a patient via a t interface 14. An air delivery conduit 16 is coupled between the flow generator 10 and the patient ace 14. The patient interface 14 may have any suitable configuration as is known in the art, e.g., full—face mask,vnasal mask, oro-nasal mask, mouth mask, nasal prongs, etc. Furthermore, the patient interface 14 also encompasses both vented and non-vented masks and dual limb mask systems. A processor 18 controls the operations of the flow generator. The flow generator is provided with a user interface unit or “comniunication system” 20 (which is generically ed to encompass both input and output systems of any suitable ure) to allow information input and a display unit 22 to display output information.

Communication System With reference to the processor is coupled with the operation sensors (shown schematically at 34) and communication system 20. The processor is programmed to te time-based or event-based es relating to one or more of flow generator operation, flow generator service, flow generator use, patient health, peripheral devices and services, patient treatment, and general reminders or the like. The user interface or communications system 20 includes structure that effects delivery of the messages. Delivery of messages may be via the display unit 22 or via an external communication device such as a modem or wireless technology such as cellular telephony or Via the internet through a k interface. With a remote communication system, the flow generator can also deliver messages to a physician, a flow generator service provider, the patient, or the like.

Time—Based es The messages generated by the processor 18 may be time-based or event- based or both. Time-based messages are generated at predetermined time intervals based on either time of use or elapsed time. Examples oftime-based messages include general reminders, where the processor is programmed to receive a reminder request input, and the messages se reminders generated at a time specified in the reminder request input. es of other time-based messages may e a notice that one or more paits should be replaced (after a certain period of use), a reminder concerning timing for apatient to schedule an appointment with their physician, a wake-up alarm, which may be an audible alarm or may be effected via the ry of breathable gas to the patient such as via pulses of air or by pressure variations, and the like. The time-based messages may be customizable by the patient for use as a‘personal er. For example, the flow tor may be mmed to remind the patient to take their pills. Advertisements may also be generated at predetermined time als, possibly in relation to a time interval when a part such as the mask or filter should be replaced.

The time-based messages may also include l user tips to assist the user in maximizing flow generator functionality. A calendar and clock filnction enables use of the system to generate wake-up alarms as well as provide time-based messages based on either time ofuse or d time. An example of a flow generator ing a built in alarm clock is disclosed in US. Patent Application Serial No. 60/703,432, filed July 29, 2005, the contents ofwhich are hereby incorporated by reference. Helpful tips and other use information can thus be provided to the patient based on the time of year.

For example, the processor may be programmed such that it knows winter months are approaching (i.e., from the calendar) and can remind the patient to utilize their humidifier. In addition, the calendar and clock function can monitor user sleep cycle and ‘ awaken the user at non-REM sleep.

Event-Based Messages Event-based messages are generated based on signals from the operation sensors 34 and are correlated to particular events or triggers detected by the processor 18 via the s 34. For example, the event—based es may relate to flow generator parts'requiring replacement br repair. The processor 18 can determine via the sensors 34 whether a particular part needs replacement or repair. For example, if a leak is detected in the mask, it may be that the mask needs to be replaced. The system may effect automatic ordering of one or more of the parts requiring replacement or generate a t for service or repair, which may be part of a user subscription. In concert with such a determination, the processor 18 may generate helpful tips to assist the user in properly positioning/wearing the mask. The sor 18 may te advertisements as event-based messages, for example when parts need replacement or as new parts/products become available. In this context, the communication system 20 may be capable ofreceiving data as message content for example via the global network through the network interface. In this manner, the message content may include information ng to new products and erals cooperatively usable with the flow generator.

Peripheral Devices The flow generator may additionally e peripheral devices providing enhanced functionality. In this context, the peripheral devices may be detected Via an identifier including an identifying element providing an identifying feature unique to a specific peripheral component able to the flow generator. The proceSsor 18 s the specific peripheral component via the identifying e. This concept is described in detail in commonly-owned US. Patent Application Serial No. 60/656,880, the contents of which are hereby incorporated by reference. In this manner, the messages generated by the processor 18 may relate to use and ion of the peripheral devices.

In one embodiment, the event-based messages e notice levels relating to flow generator operation. The notice levels are changed based on a use condition duration detected by the s 34. For example, a use condition may be a leak at the mask. In this context, a first notice level may include an indication that the leak has been ed, a second notice level may e another indication that the leak has been detected along with user tips to correct the leak, and a third notice level may include a communication notifying a service provider or physician of the leak.

AHI Threshold A patient’s specific AHI (apnea—hyponea index) threshold may be entered into the device and monitored as an indicator of the effectiveness of the therapy. AHI is a measure of the number of apnea or hypopnea events that occur per hour of sleep, which is ‘ used to assess the severity of sleep disordered ing (SDB). Commonly, an AHI of 5 or greater is considered to indicate mild OSA. Thus the AHI will vary amongst different patients, and consequently an AHI threshold will also vary between patients. The AHI threshold may be determined and entered by a clinician for an individual patient. The AHI or AHI threshold is an example of an event that may be red and reported on using the messaging system ofthe present invention. A change in the AHI index may be ered an indicator of how effective the therapy has been. For e a decrease in the AHI would indicate that the therapy was having a positive effect.

Monitoring System A remote monitoring system is described in the U.S. Patent Application Serial No. 10/934540, the‘contents of which are hereby incorporated by reference. This ‘ system is not present in the flow generator but is a patient server comprising a database of rules ing payment ofhome care devices and the s for patients and devices.

The system rs when a patient is eligible to receive payment for further home- care devices and may generate a reminder letter to send to the patient; thus reminding and encouraging patients to update their devices. The system may also be used to monitor drug prescription requirements. This type of reminder may also be included in the present application such that the reimbursement orpayment details for a patient are entered into the device or may be selected from a list, and then in a similar manner the device will remind the patient when they are eligible to purchase further equipment“ Conclusion The flow generator of the invention includes a message generating capability and communication structure that facilitate and enhance its use. The y to communicate information to the user will reduce users’ needs to contact the physician or product supplier with questions. The system can record events thereby reducing the burden and therefore labor and costs for processing insurance coverage. A calendar and clock function enables use of the system to generate wake-up alarms as well as’provide ased messages based on either time ofuse er elapsed time. Sensors enable the system to generate event—based messages. Of course, the examples described herein are exemplary, and those of ordinary skill in the art will appreciate that many variations of ' es may be generated by the flow generator of the invention, and the ion is not necessarily meant to be d to the bed examples.

. While the invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the ry, is intended to cover various ations and lent arrangements included within the spirit and scope of the invention.

Claims (36)

1. A flow generator for generating a supply of pressurised breathable gas to treat sleep disordered breathing in a patient, the flow generator comprising: a motor configured to generate the supply of able gas to a patient; at least one operation sensor to generate signals; and a processor to control operation of the flow generator, the processor configured to: determine an apnea-hypopnea index (AHI) for the patient based on the signals of the at least one operation sensor; generate a message based on the AHI; and send the message to a recipient that is remote from the flow generator.

2. The flow generator of claim 1, wherein the processor is configured to determine the AHI a plurality of times over a period of time to monitor the AHI.

3. The flow generator of claim 2, wherein the processor is configured to te a plurality of messages based on the AHI over the period of time, and send each of the plurality of messages to the recipient.

4. The flow tor of any one of claims 1 to 3, wherein the processor is configured to generate the message based on a change in the AHI.

5. The flow generator of any one of claims 1 to 4, wherein the processor is configured to e input of an AHI threshold.

6. The flow generator of claim 5, wherein the sor is configured to receive the AHI threshold from a clinician or physician.

7. The flow generator of any one of claims 5 or 6, n the AHI threshold is specific to the patient.

8. The flow generator of any one of claims 5 to 7, wherein the message is generated when the AHI is above or below the AHI old.

9. The flow generator of claim 8, wherein the message generated when the AHI is above or below the AHI old relates to an effectiveness of treatment.

10. The flow generator of any one of claims 1 to 9, wherein the processor is configured to send the message to a clinician or physician.

11. The flow generator of any one of claims 1 to 10, wherein the processor is configured to generate a further message based on the AHI and to r the further message to the patient via a user interface

12. The flow tor of any one of claims 1 to 11, wherein the processor is configured to generate a reminder message including a reminder for the patient to schedule an appointment with a physician.

13. A processor for indicating an apnea-hypopnea index (AHI) of a patient, the processor configured to: receive signals from at least one operation sensor of a flow generator, wherein the flow generator is ured to generate a supply of pressurised able gas to treat sleep disordered breathing in the patient; determine the AHI for the patient based on the signals of the at least one operation sensor; te a message based on the AHI; and send the message to a recipient that is remote from the flow generator.

14. The processor of claim 13, wherein the processor is configured to determine the AHI a plurality of times over a period of time to monitor the AHI.

15. The processor of claim 14, wherein the sor is configured to generate a plurality of messages based on the AHI over the period of time, and send each of the plurality of messages to the recipient.

16. The processor of any one of claims 13 to 15, n the processor is configured to generate the message based on a change in the AHI.

17. The processor of any one of claims 13 to 16, wherein the processor is configured to receive input of an AHI threshold.

18. The processor of claim 17, wherein the processor is configured to receive the AHI threshold from a clinician or physician.

19. The flow generator of any one of claims 17 or 18, wherein the AHI threshold is specific to the patient.

20. The processor of any one of claims 17 to 19, wherein the e is generated when the AHI is above or below the AHI threshold.

21. The processor of claim 20, wherein the e generated when the AHI is above or below the AHI threshold relates to an effectiveness of treatment.

22. The sor of any one of claims 13 to 21, wherein the processor is configured to send the message to a clinician or physician.

23. The processor of any one of claims 13 to 22, wherein the processor is configured to generate a further message based on the AHI and to deliver the further message to the patient via a user interface

24. The sor of any one of claims 13 to 23, wherein the processor is configured to generate a reminder message including a reminder for the patient to schedule an appointment with a physician.

25. A processor-implemented method for indicating an apnea-hypopnea index (AHI) of a patient, the method comprising: receiving signals from at least one operation sensor of a flow generator, wherein the flow generator is configured to generate a supply of rised breathable gas to treat sleep disordered breathing in the patient; determining the AHI for the patient based on the signals of the at least one operation ; generating a message based on the AHI; and sending the e to a recipient that is remote from the flow generator.

26. The processor-implemented method of claim 25, wherein the method comprises determining the AHI a plurality of times over a period of time to monitor the AHI.

27. The processor-implemented method of claim 26, wherein the method comprises generating a plurality of messages based on the AHI over the period of time, and send each of the plurality of messages to the recipient.

28. The processor-implemented method of any one of claims 25 to 27, wherein the method ses ting the message based on a change in the AHI.

29. The processor-implemented method of any one of claims 25 to 28, wherein the method ses receiving input of an AHI threshold.

30. The processor-implemented method of claim 29, wherein the method comprises receiving the AHI threshold from a clinician or physician.

31. The processor-implemented method of any one of claims 29 or 30, wherein the AHI threshold is specific to the patient.

32. The processor-implemented method of any one of claims 29 to 31, wherein the message is generated when the AHI is above or below the AHI threshold.

33. The processor-implemented method of claim 32, wherein the message generated when the AHI is above or below the AHI old s to an effectiveness of ent.

34. The processor-implemented method of any one of claims 25 to 33, wherein the method comprises sending the message to a clinician or physician.

35. The processor-implemented method of any one of claims 25 to 34, wherein the method comprises generating a further message based on the AHI and delivering the further message to the patient via a user interface.

36. The processor-implemented method of any one of claims 25 to 35, wherein the method comprises generating a reminder message ing a reminder for the patient to schedule an tment with a physician.