Binding enhanced therapy

Abstract

The invention discloses a combined enhanced therapy. The positive airway pressure device of the present invention comprises: a fluid generator configured to generate a supply of pressurized gas, the fluid generator comprising a programmable controller, wherein the programmable controller is configured to allow continuous access to the at least one pre-stored working mode of operation and to prevent access to the at least one pre-stored sleep mode of operation until a data signal from a user is received, each of the pre-stored working modes of operation and each of the pre-stored sleep modes of operation corresponds to a different mode of treatment for delivering positive airway pressure to the patient at a treatment level, and wherein the data signal is used to initiate at least one sleep mode of operation, a user provides the at least one sleep operation mode to the programmable controller to operate or start only selective access to the at least one sleep operation mode for a predetermined period of time; wherein the sleep mode of operation is a treatment mode that is not randomly available prior to receiving the data signal.

Description

[0001] This application is a divisional application of the invention patent application with application number 202111200777.9, application date February 16, 2007, and invention title “Combination Enhanced Therapy”. The application with application number 202111200777.9 is a divisional application of the invention patent application with application number 201510347413.1, application date February 16, 2007, and invention title “Combination Enhanced Therapy”. The application with application number 201510347413.1 is a divisional application of the invention patent application with application number 200710087962.5, application date February 16, 2007, and invention title “Combination Enhanced Therapy”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 60 / 774,222, filed February 17, 2006, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present invention relates to positive airway pressure (PAP) devices for ventilatory assistance, and more particularly, to PAP devices that provide at least one operating mode that exists during sleep. Background Art

[0005] Positive airway pressure (PAP) devices are used to treat sleep-related breathing disorders, such as obstructive sleep apnea (OSA). Colin Sullivan was the first to invent the use of nasal continuous positive airway pressure (CPAP) to treat obstructive sleep apnea (OSA), see, e.g., U.S. Pat. No. 4,944,310. OSA is characterized by partial or complete occlusion of the upper airway (i.e., apnea) during sleep. OSA sufferers repeatedly suppress their tongue and soft palate throughout sleep, resulting in reduced arterial oxygen levels and poor sleep quality.

[0006] CPAP therapy typically provides a supply of air or breathable gas from a bellows to the patient via a gas delivery conduit and a patient interface, such as a full face mask or nasal mask or nasal cannula. The air or breathable gas is typically delivered at a pressure of 4 cmH2O to 28 cmH2O and acts as a splint to maintain the patency of the airway during sleep. CPAP therapy has been shown to be effective in eliminating snoring and obstructive sleep apnea. However, some patients complain about the discomfort of CPAP therapy.

[0007] The pressure required for effective CPAP therapy varies from patient to patient. In order to determine the pressure for effective CPAP therapy for an individual, the individual usually undergoes a sleep study in a hospital, clinic or sleep laboratory. A complete sleep study is generally performed over two nights, with the first night for diagnosis of OSA and the second night for pressure titration. On the first night, the individual is observed while sleeping and parameters such as oxygen saturation, chest wall and abdominal movements, airflow, exhaled CO2, ECG, EEG, EMG and eye movements are recorded. On the second night, nasal PAP therapy is provided to the individual and the delivered therapy pressure is changed in response to the occurrence of snoring or apnea. The minimum pressure required to eliminate snoring or apnea during the night is determined to be the effective PAP therapy pressure.

[0008] Because breathing against an elevated pressure above ambient pressure can be uncomfortable, especially when attempting to sleep, it is desirable to keep PAP pressures as low as possible, especially if the individual requires long-term treatment. Low PAP pressures also result in lower mask contact pressures, which are generally more comfortable for the patient. Thus, during PAP therapy, the lowest practical treatment pressure that is effective in preventing occlusion is ideally used to provide a higher level of comfort and thereby promote compliance with the treatment.

[0009] Another type of CPAP device, known as a bilevel CPAP device, provides a first pressure during inspiration (commonly referred to as IPAP) and a second, lower pressure during exhalation (commonly referred to as EPAP). Some patients find the lower pressure during exhalation more comfortable, at least when they are awake. Examples of these devices include ResMed, Series and Respironics Series. Dual CPAP devices may be recommended for patients who are not suitable for single pressure CPAP devices.

[0010] Other types of CPAP modes designed to enhance patient comfort and compliance provide a rapid pressure reduction at the beginning of exhalation followed by a rapid return to therapeutic pressure at or near the end of exhalation. These approaches are designed to overcome the perceived problems of exhaling against high pressure and are referred to as Expiratory Pressure Relief (EPR) modes. This mode forms the basis of Respironics' C-Flex mode. See published patent applications WO2005 / 065757 and WO2004 / 112680 and U.S. Patent Nos. 5,535,738; 5,794,625; 6,105,575; 6,609,517 and 7,128,069.

[0011] Another way to improve patient comfort and compliance is to start each treatment session at a low treatment pressure (e.g., 4 cmH2O), then ramp up to full treatment pressure over a period such as the first hour. This allows the patient to adjust to the sensation as they fall asleep. Optionally, the device can be set to implement a time delay before applying full treatment pressure, which allows the patient time to fall asleep before full treatment pressure is applied. See U.S. Patents 5,199,424 and 5,522,382.

[0012] Another form of CPAP therapy may be provided by an automatically adjusting CPAP device such as the ResMed AUTOSET™ SPIRIT™ device. In this device, CPAP pressure is automatically increased or decreased based on indications of flow limitation, such as flow smoothing, snoring, apnea, and hypopnea. See U.S. Patents 5,704,345; 6,029,665; 6,138,675 and 6,363,933. These patents also describe methods and devices for distinguishing between so-called "central" and obstructive apneas. More recently, an automatically adjusting bidirectional device has been disclosed in which both IPAP and EPAP pressures are automatically increased or decreased based on the above-mentioned indications of flow limitation. See pending patent application WO2005 / 063323.

[0013] The advantage of an automatic adjustment system is that it provides the patient with increased PAP only when needed. This means that the patient is spared the inconvenience of receiving the highest treatment pressure during the entire treatment period. In addition, although the treatment pressure required for a particular patient may change over time, a properly functioning automatic system can eliminate the need for the patient to return to a subsequent sleep study to reset the treatment pressure delivered by the PAP device.

[0014] Typically, PAP devices are manufactured and tested to perform most effectively with a specific patient interface system. However, the PAP device and patient interface system are sold as separate components of a therapeutic device. As such, a patient may decide to use a particular PAP device with a patient interface system for which the PAP device has not been explicitly tested. This can result in reduced efficacy of the therapeutic system. Therefore, a system that encourages consumers to purchase compatible products would provide more effective and / or more comfortable therapy. Once compatible products are combined, they can deliver enhanced therapeutic benefits compared to the separate products alone.

[0015] The contents of all of the aforementioned patents are incorporated herein by reference.

[0016] The present invention provides improvements to known PAP devices to enhance and / or facilitate the treatment session. Summary of the invention

[0017] One aspect of the present invention is to provide a positive pressure ventilation (PAP) device including a flow generator that generates a supply of pressurized gas. The flow generator includes a programmable controller. The programmable controller is adapted to allow continuous access to at least one working operating mode and selective access to at least one sleeping operating mode. The controller includes a mode control system adapted to receive a data signal to control selective access to at least one sleeping operating mode.

[0018] Another aspect of the present invention is to provide a patient interface system adapted to generate or otherwise provide a data signal adapted to initiate a sleep mode of operation present in a PAP device. For example, the data signal may be generated by or obtained from a proximity switch present in a patient interface connector or a radio frequency identification (RFID) tag present on the patient interface system.

[0019] Other aspects of the present invention are to provide an electronic chip or card including a data signal suitable for initiating a sleep mode of operation present in a PAP device. The electronic chip or card is suitable for communicating with a mode control system present in the PAP device.

[0020] The PAP device further comprises at least one continuously available working operating mode. In an embodiment, the continuously available working operating mode is a continuous positive airway pressure (CPAP) mode.

[0021] The at least one sleep operating mode initiated by the data signal may include any known PAP mode, such as an auto-adjusting pressure mode and / or an expiratory pressure relief (EPR) mode.

[0022] Optionally, the data signal may include a pin number or code number inserted into the device using a user input unit, such as a keyboard. In an embodiment, the pin number or code number is entered into the device via a telephone or internet connection. The pin number or code number may include numbers, letters and / or symbols or any combination thereof.

[0023] In an embodiment, the sleep mode of operation is activated for a predetermined time period. The predetermined time period is controlled by a clock that is activated by a data signal. The clock can count down or count up a predetermined amount of time. The clock can count real time or the clock can count patient compliance or device usage time such as hours of use.

[0024] This sleep mode of operation can be repeatedly activated by obtaining a new data signal.

[0025] Yet another aspect of the present invention relates to a method of configuring a PAP device, the method comprising programming the PAP device with at least one primary therapy delivery mode and at least one limited access sleep therapy delivery mode, and enabling the device to access the at least one sleep therapy delivery mode only upon receipt of an activation signal, command, and / or code.

[0026] Another aspect of the present invention relates to a method of encouraging purchases of PAP devices and peripheral components from a common supplier. The method includes programming a PAP device from a common supplier to operate in at least one primary therapy delivery mode and at least one limited access sleep therapy delivery mode that can be activated only upon receipt of an activation signal, code, or command, and enabling the PAP device to operate in the at least one sleep therapy delivery mode upon operative connection of a peripheral component from the common supplier associated with the activation signal, code, or command.

[0027] Other aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which form a part of this disclosure and illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings facilitate understanding of various embodiments of the present invention. In these drawings:

[0029] Figure 1 is a perspective view of a flow generator system according to an embodiment of the present invention; and

[0030] Figure 2 is a flow chart showing an overview of one embodiment of an incorporation enhancement therapy process. DETAILED DESCRIPTION

[0031] 1.1 PAP device

[0032] Figure 1 A PAP device or flow generator system 10 is shown according to one embodiment of the present invention. As shown, the PAP device 10 includes a flow generator having a motor-driven impeller 12 that provides a supply of pressurized gas for the administration of CPAP therapy. The pressurized gas is delivered to the patient via a patient interface 14. A gas delivery conduit 16 is connected between the PAP device 10 and the patient interface 14. A programmable controller 18 controls the operation of the flow generator. The PAP device 10 may include a user interface unit 20 that allows information to be input and a display unit 22 that displays output information.

[0033] In an embodiment, the PAP device 10 includes at least two operating modes programmed into the programmable controller 18 at the time of manufacture. A first operating mode, referred to as an active operating mode, will be continuously available. The active operating mode may be a basic operating mode such as a CPAP pressure mode that delivers pressurized gas at a constant set pressure. A second operating mode, referred to as a sleep operating mode, will exist in the device in an inactive or sleep state such that the second operating mode is not arbitrarily available. The sleep operating mode will require activation from a data signal. The data signal will provide an activation signal to a module control system 34 that communicates with the programmable controller 18 and enables operation of the sleep control mode. The PAP device 10 may provide more than two operating modes, wherein one or more operating modes are continuously available and one or more sleep operating modes require activation.

[0034] 1.2 Patient Interface System

[0035] Patient interface 14 may have any suitable configuration as known in the art, such as a full face mask, nasal mask, oronasal mask, mouth mask, nasal cannula, etc. Aspects of the present invention may use masks with or without openings and single or dual line breathable gas supply systems.

[0036] 1.3 Data Signal

[0037] The data signal 32 can signal the mode control system 34 to enable the sleep mode of operation present in the PAP device 10. The mode control system 34 provides an access signal to enable the sleep mode of operation present in the PAP device 10. The data signal 32 can be communicated to the mode control system 34 in the PAP device 10 using any suitable device or system.

[0038] For example, in one embodiment, the data signal 32 may be transmitted by an electronic card or chip inserted into the PAP device 10 to provide the data signal 32 to the mode control system 34. In another embodiment, the sleep mode of operation may be activated by a specific pin number input into the PAP device 10. The pin number provides the data signal 32 to the mode control system 34 to subsequently activate at least one sleep mode of operation. The pin number may be entered into the device 10 via the user input unit 20 or the pin number may be obtained or entered into the device via remote communication, such as a telephone line or the Internet. This latter approach helps prevent multiple machines from using the same pin number to activate the sleep mode of operation by maintaining a record of the use of the pin number and preventing further use. In an embodiment, the mode control system 34 may destructively read the data signal 32 to prevent the reuse of the data signal 32 to activate multiple devices.

[0039] In an alternative embodiment, the data signal 32 may be incorporated into the patient interface system. The connection of the patient interface system, including the gas delivery conduit 16, to the PAP device 10 provides the data signal 32 to the mode control system 34 to initiate at least one sleep mode of operation. For example, the patient interface system and the PAP device 10 may include proximity switches (e.g., reed switches), such as those described in co-pending U.S. Provisional Application No. 60 / 707,950 to Resmed, filed on August 15, 2005 by Kwok et al., which is incorporated herein by reference in its entirety. The proximity switch will provide a data signal to indicate the type of component being used. The data signal may also provide the PAP device 10 with the appropriate flow characteristics of the component to which the data signal is connected to allow the sleep mode of operation to be used.

[0040] Alternatively, other forms of connector or component identification may be used as described in Resmed's co-pending U.S. Provisional Application No. 60 / 656,880, filed March 1, 2005, which is incorporated herein by reference in its entirety. For example, the patient interface system may include a radio frequency identification (RFID) tag that provides the data signal 32 to a mode control system 34 present in the PAP device 10. In this embodiment, the mode control system 34 present in the PAP device 10 is an RFID scanner that detects the data signal 32 and initiates the sleep mode of operation.

[0041] 1.4 Sleep Operation Mode

[0042] The at least one sleep operating mode present in the PAP device 10 may include any known PAP operating mode, such as automatic adjustment. Mode, dual mode, automatic dual mode and / or expiratory pressure relief type operating mode. A series of different data signals, such as an electronic chip or smart card, can be used, each signal activating a different sleep operating mode present in the PAP device 10.

[0043] As mentioned above, the sleep mode of operation can be automatically adjusted Operation mode. The mode will provide an enhanced level of comfort to the user of the PAP device because the pressure delivered is generally lower than the pressure provided by the CPAP device which is set to deliver the maximum pressure requirement. In an embodiment, a low cost system which does not require the use of a sophisticated sensor is used, for example using a stage by stage adjustment device as described in Resmed application PCT / AU2005 / 000174 filed on February 10, 2005 to provide Modes of operation, which are hereby incorporated by reference in their entirety. Alternatively, the PAP device may use the algorithmic flow evaluation system described in ResMed U.S. Provisional Application No. 60 / 624,951, filed November 4, 2004, and U.S. Provisional Application No. 60 / 625,878, filed November 8, 2004, which are hereby incorporated by reference in their entirety. Similar methods are described in WO 2004 / 067070 assigned to SAIME SA, which is hereby incorporated by reference in its entirety. It will be appreciated that any method of providing an automatic adjustment mode of operation or other PAP mode of operation is within the scope of the present invention.

[0044] Figure 2 An overview of an embodiment incorporating an enhanced therapy procedure is shown. A basic PAP device 10 is connected to a patient interface system 40. The basic PAP device 10 may provide access to a basic CPAP operating mode 42. However, if the patient interface system contains a data signal or is capable of providing a separate data signal, the basic PAP device 10 may be able to access the basic CPAP operating mode 42. Therapeutic mode (sleep mode of operation) 44. In the embodiment shown, once access is gained Therapy mode 44, then the clock is started at 46. The clock 46 may initiate the sleep mode of operation for a limited period. In an embodiment, the limited period will be related to the life of the patient interface system and may be, for example, between three and twelve months, such as six months. However, other periods are also within the scope of the present invention.

[0045] The limited operating period for activating the sleep operating mode may be controlled by a clock start that times or monitors a parameter related to the time or usage of the activated operating mode. For example, the clock may simply count down or count up a predetermined time limit using a calendar type system. In this regard, the operating mode is provided only for setting a time limit regardless of whether the device is used or not. Alternatively, the clock allows a predetermined number of hours to be used for activating the sleep operating mode, so that the clock counts the number of hours used and once the time limit is reached, the activated operating mode will stop again (see Figure 2 ). There may also be different data signals that provide different amounts of operating time.

[0046] In one embodiment, the PAP device 10 checks at 48 whether the time limit set by the data signal has expired before starting each treatment session. Therapy mode (sleep mode of operation) 44 performs therapy. If the time limit equals or exceeds a predetermined limit, the PAP device registers the time limit as expired and blocks further access to the sleep mode of operation. In this way, only the basic CPAP mode of operation 42 is allowed.

[0047] Optionally, the basic PAP device can periodically check the clock throughout the treatment period. If the time limit is not reached, the visit is maintained. Therapy Mode (Sleep Mode of Operation) 44. However, once the time limit is reached, access to the Sleep Mode of Operation will terminate and the PAP device will revert to the Basic CPAP Only Mode of Operation 42.

[0048] In other embodiments, the PAP device will include a "sleepout" feature that allows the current treatment session to continue. The "sleepout" feature will prevent the patient from being uncomfortable or waking up from sleep due to the sleep mode of operation switching to the basic CPAP mode when the patient is asleep. Thus, if the time limit expires during a treatment session, the sleep mode of operation will not stop immediately, but one or more of the following scenarios may apply:

[0049] The device will remain in the activated sleep mode of operation until the treatment period is complete; or

[0050] The device will remain in the activated sleep mode of operation for another predetermined time. The duration of the predetermined time can be fixed (e.g., 5 hours) or adjustable (e.g., adjustable within a range of 4 to 10 hours). Optionally, the predetermined time can be established by the duration of an average predetermined treatment period. For example, the average treatment period duration is calculated for the previous (e.g., 5 hours) treatment period. In order to avoid calculating an undesirable low predetermined time, the time of the default period can be included to take precedence over the undesirable shorter previous treatment period. For example, if the previous treatment period is less than 5 hours in duration, the default period of 5 hours will replace the shorter period in the average calculation. The calculated average value is set to the predetermined time, and the predetermined time will be applied only when the time limit period set by the data signal expires, making the sleep mode of operation continuously available.

[0051] like Figure 2 As shown, the sleep mode of operation can be repeatedly activated by another data signal 50. Other data signals can be provided by purchasing other patient interface systems. The data signal will again allow access to Therapy mode 44 and the process will be repeated. Each additional initiation of the sleep mode of operation by a data signal will begin a new sleep mode of operation for a predetermined period of time.

[0052] In further embodiments, the PAP device will notify the user that the system has changed from the sleep mode of operation to the basic CPAP mode. This is accomplished by a message appearing on a video display, an audio signal, and / or a communication to a computer via a wireless or hardwired network. The system may provide a reminder to the user that it is time to replace the patient interface system and / or it is time to obtain new data information. In embodiments, the device may provide a reminder to the patient prior to the expiration of a predetermined time limit. The information may also provide instructions to the user regarding the use of the device and details of contact with a clinician or other medical personnel.

[0053] Under default settings, the PAP device will provide basic PAP operating functions. Additional data signals, such as an RFID tag or pin code present on an electronic chip or card will access enhanced performance in the form of a sleep operating mode present within the PAP device. The data signal is read by the mode control system, which is then able to access the sleep operating mode. In one embodiment, the mode control system will routinely check the data signal location, for example every ten seconds or one minute. If a valid data code is detected, the sleep operating mode can be and continues to be accessed. If no data signal is detected or the detected data signal is invalid, the sleep operating mode remains dormant because access is denied.

[0054] In another embodiment, the mode control system can destructively read the data signal and enable access to the sleep mode of operation for a predetermined amount of time. In this way, the mode control system can start a clock that times the predetermined time that the sleep mode of operation is used. Once the predetermined time has been reached, the signal is turned off and the PAP device is restored to the default settings that provide basic PAP therapy. In embodiments, the mode control system can be pre-programmed to recognize a set of data signals. In other embodiments, the mode control system can receive a software upgrade to allow additional pre-programming to recognize additional data signals.

[0055] 1.5 Data signal packaging

[0056] The data signal required to initiate the sleep mode of operation in the PAP device may be packaged with a compatible patient interface system to encourage purchase of a compatible patient interface system. An electronic chip, electronic card, pin number or serial number, or any other data signal means is provided within the patient interface packaged or issued when the patient interface system is purchased. Optionally, as previously described, the data signal is built into the patient interface system.

[0057] Other aspects of the present invention may include additional non-therapeutic benefits (i.e., user loyalty programs) associated with continued use of a particular type of patient interface system. If a patient is shown to be continuously using a particular type of patient interface system, the treatment of accessing the sleep mode of operation can be sustained for a longer period of time. For example, after three mask replacements, the sleep mode of operation can be activated for 8 months instead of 6 months. Optionally, continued use of a particular type of patient interface system can earn "loyalty points" that can be used to discount products or services. The number of these "loyalty points" can be reported by a coded value displayed on an LCD or via a smart card system. This system can also advantageously provide data on the models purchased by consumers, and uniquely encode the style and size of each patient interface system provided, which helps company management and planning. Sales organizations can also be provided with some history of patient interface systems used by repeat customers so that if a new form or improved version is on the market, they can identify potential new patient interface systems for consumer trials.

[0058] Although the present invention has been described in conjunction with what are currently considered to be the most practical and preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments, but rather, the present invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the present invention. Of course, the various embodiments described above may also be implemented in conjunction with other embodiments, for example, multiple aspects of one embodiment may be combined with multiple aspects of another embodiment to implement other embodiments. In addition, although the present invention has particular application to patients with OSA, it should be appreciated that patients with other diseases (e.g., congestive heart failure, diabetes, morbid obesity, stroke, obesity surgery, etc.) may also benefit from the above teachings. Moreover, the above teachings have similar utility in non-medical applications with patients and non-patients.

Claims

1. A peripheral component of a PAP device for providing different treatment delivery modes for a patient to treat sleep-disordered breathing, the peripheral component comprising: an activation signal, code or command within the peripheral component, wherein the connection of the peripheral component to the PAP device causes the activation signal, the code or the command to be automatically transmitted to the programmable controller of the PAP device, Wherein, the activation signal, the code or the command is configured to allow access to at least one limited-access sleep therapy delivery mode of the PAP device so that the PAP device can switch from at least one primary therapy delivery mode to the at least one limited-access sleep therapy delivery mode.

2. The peripheral component of claim 1, wherein the structure of the peripheral component is configured to facilitate the delivery of compressed air to the patient.

3. The peripheral component of claim 1, further comprising a radio frequency identification (RFID) tag configured to interact with a scanner on the PAP device to provide the activation signal to the PAP device.

4. The peripheral component of claim 1, further comprising a proximity switch configured to interact with a switch on the PAP device to deliver the activation signal to the PAP device.

5. The peripheral component of claim 1, wherein the activation signal is configured to provide the PAP device with appropriate flow characteristics suitable for the peripheral component.

6. The peripheral component according to any one of claims 1 to 5, wherein the peripheral component comprises a patient interface, a gas delivery conduit and / or a humidity regulator.

7. A peripheral component according to claim 6, wherein the patient interface is configured to sealingly engage with the patient's face when in use.

8. The peripheral component of claim 6, wherein the gas delivery conduit is configured to deliver compressed air from the PAP device to a patient.

9. A system for selectively providing different therapy delivery modes for a PAP device, the system comprising: A PAP device comprising a flow generator configured to generate a supply of compressed air for delivery to a patient to treat sleep disordered breathing, the flow generator comprising a programmable controller; as well as A peripheral component according to any one of claims 1 to 5.

10. A system according to claim 9, wherein the programmable controller is configured to allow the PAP device to operate in at least one primary therapy delivery mode and at least one limited access sleep therapy delivery mode, wherein the at least one limited access sleep therapy delivery mode can only be activated upon receipt of an activation signal, code or command.

11. The system of claim 10, wherein access to the at least one limited access sleep therapy delivery mode is blocked until an activation signal, code, or command is received.

12. A method for encouraging the purchase of PAP devices and peripheral components from a common supplier, comprising: Programming a PAP device from a common vendor to operate in at least one primary therapy delivery mode and at least one limited access sleep therapy delivery mode that is activated only upon receipt of an activation signal, code, or command; and Once operatively connected with a peripheral component from a common vendor associated with an activation signal, code, or command, the PAP device can be operated in at least one sleep therapy delivery mode.

13. The method of claim 12, wherein the peripheral components include a mask, a gas delivery conduit, and / or a humidity regulator.

14. The method of claim 12, wherein associating the peripheral component with the enablement signal comprises integrating or embedding the enablement signal into the peripheral component.

15. The method of claim 12, further comprising rewarding consumers for continued use of peripheral components from a common supplier.

16. The method of claim 15, wherein the reward to the consumer comprises extending access time to the at least one sleep therapy delivery mode.

17. The method of claim 15, wherein the incentive to the consumer comprises providing a discount on a product or service from a common supplier.

18. The method of claim 12, wherein the at least one primary therapy delivery mode is continuously available to a patient using the PAP device.

19. The method of claim 12, further comprising enabling at least one limited access sleep therapy delivery mode only for a predetermined period of time after the at least one limited access sleep therapy delivery mode is initially enabled.

20. The method of claim 19, further comprising extending operation of the at least one limited access sleep therapy delivery mode in the event that the predetermined period of time elapses or expires while operating in the at least one limited access sleep therapy delivery mode.

21. The method of claim 20, wherein the extension lasts until the end of the corresponding treatment period.

22. The method of claim 20, wherein the extending lasts for a predetermined time.

23. The method of claim 22, wherein the predetermined time is an average duration of previous treatment sessions.

24. A positive pressure ventilation device, comprising: a flow generator configured to generate a supply of compressed air, the flow generator comprising a programmable controller; wherein the programmable controller is configured to allow continuous access to at least one pre-stored working operating mode and to prevent access to at least one pre-stored sleeping operating mode before receiving a data signal from a user, each of the pre-stored working operating modes and each of the pre-stored sleeping operating modes corresponding to a different treatment plan in which positive pressure ventilation is delivered to the patient at a therapeutic level, wherein the data signal is used to initiate at least one sleep mode of operation, and the data signal is provided by a user to the programmable controller to selectively enable or activate only a predetermined period of at least one sleep mode of operation; Therein, the sleep operation mode is a treatment mode that is not freely available for use before receiving the data signal.

25. The positive airway pressure device of claim 24, wherein at least one operating mode of operation is a continuous positive airway pressure mode.

26. The positive airway pressure device of claim 24, wherein the at least one sleep operating mode is an auto-adjusting pressure mode.

27. The positive airway pressure device of claim 24, wherein the at least one sleep operating mode is an expiratory pressure relief mode.

28. The positive airway pressure device of claim 24, wherein the data signal is present on an electronic chip or card.

29. The positive airway pressure device of claim 28, wherein the electronic chip or card is inserted into a signal receiving portion within the flow generator to provide a data signal to the programmable controller to temporarily enable or activate the sleep mode of operation.

30. The positive airway pressure device of claim 24, wherein the data signal is a pin number.

31. The positive airway pressure device of claim 24, wherein the data signal is a serial number.

32. The positive airway pressure device of claim 30, wherein the flow generator comprises a user input unit, and the pin number is input using the user input unit.

33. The positive airway pressure device of claim 31, wherein the flow generator comprises a user input unit, and the number is input using the user input unit.

34. The positive airway pressure device of claim 32, wherein the user input unit is a keyboard.

35. The positive airway pressure device of claim 33, wherein the user input unit is a keyboard.

36. The positive airway pressure device of claim 30, wherein the pin number is received via a telephone or internet connection.

37. The positive airway pressure device of claim 31 , wherein the number is received via a telephone or internet connection.

38. The positive airway pressure device of claim 30, wherein the pin number is one or more selected from numbers, letters, and symbols.

39. The positive airway pressure device of claim 31, wherein the number is one or more selected from numbers, letters, and symbols.

40. A positive pressure ventilation device according to claim 24, wherein the data signal is present in the patient interface system, and the connection between the patient interface system and the flow generator is configured to provide the data signal to the programmable controller to temporarily enable or activate a predetermined period of at least one pre-stored sleep operating mode.

41. The positive airway pressure device of claim 40, wherein the data signal is a proximity switch in the patient interface system.

42. The positive airway pressure device of claim 40, wherein the data signal is a radio frequency identification tag in a patient interface system.

43. The positive airway pressure device of claim 24, wherein the programmable controller includes a clock that is activated by a data signal and controls the predetermined period.

44. The positive airway pressure device of claim 43, wherein the clock counts down the predetermined period.

45. The positive airway pressure device of claim 24, wherein the predetermined period corresponds to an amount of time counted in real time.

46. ​​The positive airway pressure device of claim 24, wherein the predetermined period corresponds to hours of use.

47. The positive airway pressure device of claim 24, wherein the at least one sleep mode of operation is repetitively activatable by a data signal.

48. A patient interface system configured to generate or otherwise provide a data signal in response to a user request, the data signal being used to initiate at least one sleep mode of operation and configured to temporarily enable or activate a sleep mode of operation present in a positive pressure ventilation device for a predetermined period of time, the sleep mode of operation corresponding to a therapeutic regimen of delivering positive pressure ventilation to a patient at a therapeutic level; in, The sleep mode of operation is a therapy mode that is not freely available for use until the data signal is received.

49. A patient interface system according to claim 48, wherein the data signal is generated or obtained by a proximity switch.

50. A patient interface system according to claim 48, wherein the data signal is generated or obtained by a radio frequency identification tag.

51. A method of configuring a positive pressure ventilation device, comprising: programming the positive pressure ventilation device with at least one primary therapy delivery mode and at least one limited access sleep therapy delivery mode, each primary therapy delivery mode and each limited access sleep therapy delivery mode corresponding to a different therapy regimen in which positive pressure ventilation is delivered to the patient at a therapeutic level; and causing access to said at least one sleep therapy delivery mode for a predetermined period of time only upon receipt of an activation signal, command and / or code from a user; Among other things, a restricted access sleep therapy delivery mode is a therapy mode that is not freely available for use until an activation signal, command, and / or code is received.

52. The method of claim 51 , further comprising providing a mode control system to the positive airway pressure device to receive activation signals, commands and / or codes to control access to the at least one sleep therapy delivery mode.

53. The method of claim 51 further comprising providing an activation signal, command and / or code on an electronic chip or card.

54. The method of claim 53, further comprising inserting an electronic chip or card into a signal receiving portion within the positive airway pressure device to provide an activation signal.

55. An electronic card or chip comprising a data signal adapted to initiate a sleep mode of operation present in a PAP device.

56. A patient interface system adapted to generate or otherwise provide a data signal adapted to initiate a sleep mode of operation present in a PAP device.

57. A method of configuring a PAP device, comprising: programming the PAP device with at least one primary therapy delivery mode and at least one limited access sleep therapy delivery mode; and The at least one sleep therapy delivery mode is accessed only upon receipt of an activation signal, command and / or code.

58. A positive pressure ventilation device configured to provide a first pressure during inspiration and a second, lower pressure during exhalation.

59. A positive pressure ventilation device configured to provide a rapid pressure reduction at the beginning of exhalation, followed by a rapid return to a therapeutic pressure at or near the end of exhalation.

60. A positive pressure ventilation device configured to implement a time delay before applying full therapeutic pressure.

61. A gas delivery conduit configured to be connected between a positive pressure ventilation device and a patient interface.

62. A positive pressure ventilation device, comprising: a user interface unit allowing information input; as well as A display unit that displays output information.

63. A method for determining an effective continuous positive airway pressure therapy pressure for an individual, the method comprising: On the first night, the subjects were observed while they slept, including measurement and recording of oxygen saturation, chest wall motion, abdominal motion, airflow, expired CO2, ECG, EEG, EMG, and eye movements; On the second night, providing positive airway pressure therapy to the individual and altering the positive airway pressure therapy in response to the onset of snoring or apnea; as well as Determine the minimum pressure required to eliminate snoring and apnea during the second night.

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