WO2000069337A1

WO2000069337A1 - Cpap and nippv apparatus having audio communication

Info

Publication number: WO2000069337A1
Application number: PCT/AU2000/000450
Authority: WO
Inventors: Alexander Virr; Peter John Deacon Wickham
Original assignee: Resmed Limited
Priority date: 1999-05-13
Filing date: 2000-05-12
Publication date: 2000-11-23
Also published as: AUPQ033199A0

Abstract

A Non-Invasive Positive Pressure Ventilation (NIPPV) apparatus (10) has a controller (20) that has control over a motor/impeller arrangement (12) in the delivery of pressurising air or breathable gas to a mask (16) by a conduit (14). The controller (20) provides output signals relating to diagnostic states or operation, such as patient compliance, to a voice output generator (24). The generator (24) includes a phrase memory (28) that stores a plurality of phrases which are sequenced by a sequencer (30), then converted to an analog form and announced by a loudspeaker (26).

Description

CPAP AND NIPPV APPARATUS HAVING AUDIO COMMUNICATION

Field of the Invention

This invention relates to continuous positive airway pressure (CPAP) and Non

Invasive Positive Pressure Ventilation (NIPPV) treatment apparatus, and particularly, apparatus that present operational information through audio communication.

Background Art

CPAP and NIPPV apparatus function to supply a patient with a supply of clean breathable gas (usually air, with or without supplemental oxygen) at a prescribed pressure or pressures, at appropriate times during the patient's breathing cycle.

An example of a suitable device in which the present invention may be included is the AutoSet^® T device (ResMed Ltd.), which may be used for treating sleep disordered breathing, such as Obstructive Sleep Apnea (OSA) and flow limitation, as described in US Patent . 5,704,345 (Berthon-Jones).

NIPPV or CPAP apparatus typically include a flow generator, an air filter, a mask, an air delivery conduit connecting the flow generator to the mask, various sensors and a microprocessor-based controller. The flow generator may include a servo-controlled motor and an impeller. The flow generator may also include a valve capable of discharging air to atmosphere as a means for altering the pressure delivered to the patient as an alternative to motor speed control. The sensors measure, amongst other things, motor speed, gas volumetric flowrate and pressure. The apparatus may optionally include a humidifier in the air delivery circuit. The controller may include data storage capacity with and without integrated data retrieval and display functions.

In this document, "treatment apparatus" will imply a reference to CPAP or

NIPPV apparatus.

CPAP apparatus are mostly used and operated by the patients themselves in a home environment. Conventional interaction with treatment apparatus is by a series of input devices such as pushbuttons, and output devices such as LEDs. LCDs, audible alarms and pressure indicators. The sophistication of known treatment apparatus, in functions such as timed or ramped start-up (for example as described in US Patent No. 5,199,424 and US Patent No. 5,522.382 assigned to ResMed Ltd) and mask fitting test modes can mean that a considerable degree of interaction by the patient with the apparatus is required.

Usually, status or diagnostic information on the operation of treatment apparatus is available from the controller. The status or diagnostic information may include the set pressure, delay timer or ramp times, the expiratory (EPAP) phase pressure and the inspiratory (IPAP) phase pressure, patient compliance hours, the apparatus use history and fault information. The status or diagnostic information is useful to one or more of the patient, clinician or service technician.

It is desirable for the status of the treatment apparatus and of treatment to be checked remotely by persons including physicians, technicians and clinicians. Remote interrogation by such persons allow more economical establishment of the status of a large number of treatment apparatus and the treatment of patients, thereby eliminating the need for home visits or for the apparatus to be returned to the clinician or service office.

A known way of communicating with a CPAP apparatus is with a cabled remote control, for example, the REMStar Choice™ Machine (Respironics, Inc. Pittsburgh, PA, United States of America). The remote control for this device has an On/Off button and a Ramp button.

Another known way of communicating remotely with treatment apparatus is via clinical control units, such as UCU2 (ResMed Ltd). The UCU2™ is typically used in a clinical setting by sleep study professionals and may be connected to a range of machines, such as the ResMed Ltd Sullivan III™ group of CPAP machines, the ResMed Ltd Sullivan V™ group of CPAP machines or the ResMed Ltd VPAP II™ group of machines. Connection of the UCU2 to the machine is via a physical lead, such as an 8-core cable with miniature 8-pin connector, or a cable with RJ11 connectors. The UCU2 functions include the capacity to vary the parameter settings within the connected machine as well as analog outputs for connection to chart recorders to provide a record of signals such as the pressure, leak, and flow. The UCU2 also includes an LCD screen for displaying information such as the connected machine's current operating mode and set pressure.

Both of these known ways of remote communication with treatment apparatus are inconvenient to use over distances much greater than a few meters.

One alternative way to obtain the status or diagnostic information would be make a telephone call to the patient and request the patient to interrogate their treatment apparatus in the conventional manner; that is, through manipulation of the appropriate control switches. However, there can be a considerable inconvenience or difficulty for the patient to obtain the status or diagnostic information from the treatment apparatus. This task often requires progressing through a sequence of data presented by the existing output device. Many patients using treatment apparatus are limited in their ability to operate such a device because of the complexity of the operation or because they have limited physical movement and dexterity due to their age or illness. Further, they may suffer from poor eyesight.

A disadvantage of having a brightly lit display, on the other hand, is that the projected light may disturb those trying to sleep.

There is a further need for the status or diagnostic information to be independent of patient perception. For example, the clinician may be interested to compare the treatment true compliance with the patient's perception of their degree of compliance.

An arrangement to independently and remotely obtain the status or diagnostic information is to download the information using a computer link and a modem, which may be built into the treatment apparatus. However, when used in a patient's home, this requires the patient to disconnect their telephone and connect the treatment apparatus directly to the telephone line. Alternatively, an additional telephone line is required.

The above arrangement presents a considerable inconvenience for the patient. Furthermore, modem-based communication requires that the person wishing to communicate remotely with the treatment apparatus has access to a computer and a modem.

Summary of the Invention

The presented invention is directed to overcoming or at least ameliorating one or more of the disadvantages in the prior art.

Accordingly, the invention discloses CPAP or NIPPV treatment apparatus that provides information through audio communication, the apparatus comprising: a flow generator for supplying breathable gas; a controller for controlling operation of the flow generator; a conversion circuit; and announcement means coupled to the conversion circuit; wherein the controller provides output data concerning operation of the treatment apparatus to the conversion circuit that converts the data to an audio form to be output by the announcement means.

Preferably, the audio form resembles the human voice.

The announcement means can be a loudspeaker, piezoelectric device or any the other suitable audio reproduction device. The conversion circuit can include the sequential connection of a phrase memory, a sequencer and a digital-to-analog converter.

In another aspect, the announcement means provides information selectable between a variety of different languages, for example, English, French, German and Japanese.

The output data from the controller can be in response to input data, representing commands, instructions or numeric values, made by input devices of the treatment apparatus that are coupled to the controller. Alternatively, or in addition, the output data from the controller can be in response to operational or internal diagnostic states of the treatment apparatus determined by the controller.

Input commands or instructions can be provided by pushbuttons or the like, or by audio input means, for example, a tone detection circuit coupled to the controller. Additionally, the voice form information can also be transferred to a remote location via a telephone or radio link.

The invention further discloses a method for communicating information from CPAP or NIPPV treatment apparatus, the method comprising the steps of: generating an output data signal representing information concerning operation of the treatment apparatus that is to be communicated; converting the data signal into an audio form; and reproducing the audio form.

The audio form preferably resembles the human voice.

Preferably, the method comprises the further steps of detecting an input command or instruction or an operational or internal diagnostic state of the treatment apparatus, and generating a relevant said output electrical signal in response thereto.

Preferably, the method comprises the further steps of recording the input command or instruction in a data storage means.

By combining the audio input and voice form output aspects, an operator can remotely provide input instructions to the apparatus using a tone generator and obtain return information through voice communication via an audio communication link.

Accordingly, the invention further discloses a method for communicating information concerning a patient's CPAP machine to a remote location, comprising the steps of: establishing a telephone link between the remote location and the patient's telephone; establishing audio communication between the patient^'s telephone and the CPAP machine; sending a command message from said remote location via the telephone link to be audibly announced to said CPAP machine; and announcing an information containing response by said CPAP machine to be transmitted to said remote location by said telephone link. In this way the physician or technician can remotely interrogate the treatment apparatus without requiring complex equipment. For example, the treatment apparatus status could be checked using any ordinary pushbutton telephone, such as a standard mobile cellular phone.

In another aspect, it may be necessary for the remote operator to supply a security code before the treatment apparatus will accept further commands. This additional security feature can prevent inadvertent missetting of the treatment apparatus by the patient or another person, or the release to unauthorised persons of data, intended for addition to a patient's confidential medical file.

Brief Description of the Drawings

Embodiments of the invention will now be described with reference to the accompanying drawings, in which:

Fig. 1, shows a schematic block diagram of treatment apparatus having audio communication;

Fig, 2 shows a further embodiment of treatment apparatus having voice communication output and tone input;

Fig, 3 shows an exterior of treatment apparatus having voice communication;

Fig. 4 shows a flowchart of a process for coordinating signals to input ports and from output ports of the treatment apparatus.; and

Fig. 5 shows a block diagram of an embodiment of the invention where the input device includes a speech recognition chip.

Detailed Description of Preferred Embodiments and Best Mode

An NIPPV apparatus 10 is shown in Fig. 1 , and has a controllable motor/ impeller arrangement 12 receiving a supply of air or breathable gas and providing a flow of air or gas at an outlet to an air delivery hose 14 that transports the air or gas to a patient mask 16. The output pressure of the NIPPV apparatus 10 is determined by the speed of the motor/ impeller arrangement 12, which is controlled by the controller 20. The speed of the motor/ impeller arrangement 12 is cyclically changed to match patient respiratory phase providing the desired IPAP and EPAP phase pressures at the patient mask. It will be understood that the invention also can be embodied in a constant level or automatically adjusting CPAP apparatus, such as the present Applicant's AutoSet T (™) machine.

The controller 20 also receives data signals relating to pressure and flow in the delivery hose 14 from in-line sensors 18. The controller 20, upon receiving data, representing commands, instructions or numerical values from input devices 22, further provides a corresponding or related output command to the voice output generator 24, associated with a loudspeaker 26. The loudspeaker 26 outputs a corresponding simulated or pre-recorded human voice. In the preferred embodiment, the controller includes a Central Processing Unit (CPU), memory, and input and output ports, such as parallel or serial ports. The CPU executes code, which can read from and written to the input and output ports.

The input devices 22 can be implemented by pushbuttons, touch screens, or the like. Other forms of inputs to the controller 20 can result in the generation of an output signal to the voice generator 24. These can be diagnostic states generated within the controller 20 or in response to the pressure and flow sensors 18, so far as there may be an abnormal operational condition.

The voice output generator 24 includes a phrase memory 28 that stores a plurality of output phrases available for output to the loudspeaker 26. The voice output generator 24 further includes a sequencer 30 that selects a combination of phrases from the phrase memory 28 to be outputted to the loudspeaker 26 via a digital to analog converter 32. The voice output generator 24 can be embodied in an integrated circuit of the type MSM6650, manufactured by OKI of Japan. This integrated circuit includes digital memory in which phrases may be stored. This family of integrated circuits allows up to 2 megabits of phrase memory to be stored. The amount of memory required for each phrase is dependent on the sampling rate used. A minimal set of phrases stored in the phrase memory 28 is listed in the following table:

Index Digitised Phrase

0 "zero"

1 "one"

2 "two"

3 "three"

4 "four"

5 "five"

6 "six"

7 "seven"

8 "eight"

9 "nine"

10 "point"

11 "hours"

12 "minutes"

13 "centimeters"

14 "Ready"

15 "Report"

Fig. 2 shows an electrical block diagram of the NIPPV apparatus 10, having a voice output generator 24 as well as a tone input arrangement by which commands or instructions can be provided. The purpose of the tone input arrangement is to serve as alternative to the conventional input devices 22. Thus, the NIPPV controller 20 can additionally receive inputs from the audio input device 40. The operator, who may be the patient or another person, would, using a tone generator 50, provide commands to the NIPPV controller via the audio input device 40. The audio signals from the tone the generator 50 are received by the microphone 42 and supplied to a frequency discriminator 44 via an amplifier 46. The frequency discriminator 44 provides inputs to the controller 20 that corresponds with the command represented by the audio signals from the tone generator 50. In the preferred embodiment, the tone generator 50 is a DTMF generator and the frequency discriminator 46 is a DTMF decoder, accepting a sequence of tones and provides corresponding output signal to the controller 20.

The following table gives an example of the mapping between DTMF tones and an input instruction:

DTMF Tone Instruction

0 Test tone, to check device is listening 1 Report patient compliance hours

2 Report Apnea Hypopnea Index (AHI) Report Mean pressure/ Minimum pressure in the last period (AutoSet machine only)

4 Report accumulated apnea time 5 Report accumulated snore time 6 Report NIPPV apparatus serial number 7 Report fault conditions 8 Report mask/ cushion type 9 Report pressure set point

99 Quit

# Enter

The embodiment of Fig. 2 otherwise functions in the same manner as the embodiment of Fig. 1 so far as the output of information by the voice output generator 24 is concerned.

Referring now to Fig, 3, in the preferred embodiment, the loud speaker 26 and the microphone 42 are arranged on the NIPPV apparatus 10 with a suitable space between them, allowing a conventional telephone handset 60 to be placed adjacent them, facilitating remote communication. The NIPPV apparatus is further equipped with a switch 61 to initiate the communication procedure. Advantageously, this switch 61 can be illuminated to indicate successful communication. Should the NIPPV apparatus 10 not receive a valid command in a predetermined time period, the illumination for switch 61 can be switched off automatically.

Referring to Fig. 4, a preferred procedure for communicating to and from the NIPPV apparatus 10 is will be described as follows.

The physician, technician, clinician or other person wishing to communicate remotely calls the patient and requests that the telephone handset 60 be placed over the microphone 42. The patient then presses the "Talk" button 61 (step 100) on the NIPPV apparatus 10. This button 61 is initially not illuminated (i.e. "lit"). When the NIPPV apparatus 10 detects DTMF tones (step 105), (omitting a few steps), the "talk" button 61 becomes illuminated (step 1 10). This visual feedback enables the patient to know that the telephone handset 60 is correctly positioned. For example, the patient may inadvertently place the telephone handset microphone adjacent to the NIPPV apparatus microphone 42 inhibiting voice communication. After successfully receiving DTMF tones, should the controller 20 not receive a valid command within a predetermined time, for example, 1 minute, then the "Talk" button 61 illumination will be turned off (step 115), and the procedure will end (step 120).

Fig. 4 shows various other steps not apparent to the patient when the talk button is pressed a timer (t) is set to the current time (step 125). The time-out function follows (step 130). Next, there is command/digit discrimination between the "Enter" command (steps 135, 140), followed by a string length determination (steps 145, 150). The 'button lit' test then follows (step 155), after which the command/digit string is executed (step 160). A command string is cleared once execution has occurred (step 165).

In an alternative embodiment, to ensure that the telephone handset 60 is correctly placed near the NIPPV apparatus 10, the person dialling remotely may dial a test tone. If the NIPPV apparatus 10 successfully detects the test tone, the NIPPV apparatus 10 will announce the phrase "Ready".

The person communicating remotely, having first dialled the test tone and having heard that the NIPPV apparatus is "Ready", may then proceed dialling the appropriate command, followed by the hash (#) key. The NIPPV apparatus 10 then "answers". A series of commands may be issued, each being followed by the hash key and each query being "answered". To terminate the call, the person communicating remotely dials "99" followed by the hash key, at which point the "talk" button 61 illumination will be turned off.

In one embodiment, the NIPPV apparatus 10 only reports the relevant number(s). For example, suppose the NIPPV apparatus 10 had the following conditions: pressure set point 15 cmH₂O, previous session compliance time 5 hours, 10 minutes. The input and corresponding outputs are given in the following table:

Input Output

0 # "Ready"

1 # "Report" "One" <pause> "five"

"hours" "one" "zero" "minutes" 9 # "Report" "Nine" <pause> "one" "five"

"centimeters"

In another embodiment, where the phrase memory 20 is sufficiently large, instead of responding with the report number, the apparatus will speak a longer phrase describing the report, for example in response to an input of " 1#", the apparatus will respond with "Patient compliance time", followed by the time.

In another embodiment, a mobile phone (not illustrated) can be factory installed inside the treatment apparatus 10, with electrical connections to the speaker 26 and microphone 42 circuits. The person communicating remotely dials the number of the mobile phone and follows the same series of commands as in the previously described embodiment.

In another embodiment, the phrase memory contains "help" files to assist either the local or remote user in operating the treatment apparatus. A standard set of instructions may be stored regarding the use of the equipment and, optionally, particular instructions for the patient as for example might be provided by a physician. In one mode, the function of each button on the treatment apparatus is described by the pre-recorded or simulated voice output whenever that button is pressed. In another mode, the pre-recorded or simulated voice provides instructions as to how to assemble correctly the mask, harness and air delivery conduit. In another mode, the apparatus provides pre-recorded or simulated voice warnings when the apparatus is not correctly assembled, or when a part, for example, a filter, needs changing and may also deliver instructions to correct the situation.

Referring now to Fig. 25, another form of the input device 22' will be described, and includes a microcontroller to 180 with speech recognition faculty, such as the RSC- 164 integrated circuit (Sensory, Inc. CA, USA). The input device 22' includes a microphone 182, a preamplifier and gain control section 1, 184, the RSC-164 chip 1 , 180 , and an external memory 1, 186, for example, Flash Memory. In this embodiment, remote communication with the treatment device 10 can be accomplished without the need to dial tone commands. Instead, the speech recognition circuit 180 can recognise spoken instructions. For example, the speech recognition chip can be programmed to recognise numbers and commands such as "compliance", "faults", "apnea hypopnea index", "mean pressure". By using Flash memory 1, 186 as the external memory, the device can be customised to recognise different voices or languages. Once an input has been recognised, the appropriate data string is placed on the output bus 188 to the controller 20.

Although the invention has been described with reference to a preferred embodiment, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Claims

Claims:

1. CPAP or NIPPV treatment apparatus that provides information through audio communication, the apparatus comprising: a flow generator for supplying breathable gas; a controller for controlling operation of the flow generator; a conversion circuit; and announcement means coupled to the conversion circuit; and wherein the controller provides output data concerning operation of the treatment apparatus to the conversion circuit that converts the data to an audio form to be output by the announcement means.

2. Apparatus as claimed in claim 1, wherein said conversion circuit includes the sequential connection of a phrase memory, a sequencer and a digit-to-analog converter.

3. Apparatus as claimed in claim 2, wherein said announcement means includes a loudspeaker or piezoelectric device.

4. Apparatus as claimed in any one of claims 1 to 3, further comprising an input device, coupled to said controller, by which input data is provided, and in response to which one or more of said output data are provided to said conversion circuit.

5. Apparatus as claimed in claim 4, wherein diagnostic states sensed by the controller result in one of said output data being provided to said conversion circuit.

6. Apparatus as claimed in either one of claim 4 or claim 5, wherein said input device includes pushbutton circuits.

7. Apparatus as claimed in claim 6, wherein said pushbutton circuits generate DTMF tones, provided to said controller.

8. Apparatus as claimed in either one of claim 4 or claim 5, wherein said input device includes a tone detection circuit.

9. Apparatus as claimed in claim 8, wherein said tone detection circuit generates DTMF tones.

10. A method for communicating information from CPAP or NIPPV treatment apparatus, the method comprising the steps of: generating an output data signal representing information concerning operation of the treatment apparatus that is to be communicated; converting the data signal into an audio form; and reproducing the audio form.

11. A method as claimed in claim 10, wherein said audio form resembles a human voice.

12. A method as claimed in either one of claim 10 or claim 11, comprising the further steps of: receiving input data that causes generation of a said output data signal.

13. A method as claimed in claim 12, wherein said operational information includes diagnostic states of the apparatus.

14. A method as claimed in either one of claims 13 or 14, wherein said receiving step includes receiving DTMF tones.

15. A method as claimed in any one of claims 10 to 14, wherein said converting step includes the steps of: searching a phrase memory for one or more phrases corresponding to said data signal; and sequencing said one or more phrases.

16. A method for communicating information concerning a patient's CPAP machine to a remote location, comprising the steps of: establishing a telephone link between the remote location and the patient's telephone; establishing audio communication between the patient's telephone and the CPAP machine; sending a command message from said remote location via the telephone link to be audibly announced to said CPAP machine; and announcing an information containing response by said CPAP machine to be transmitted to said remote location by said telephone link.

17. A method as claimed in claim 16, wherein said information is CPAP therapy compliance.