Methods and Systems for the Treatment of Sleep Apnea
20190167929 ยท 2019-06-06
Inventors
Cpc classification
A61M16/0069
HUMAN NECESSITIES
A61M16/024
HUMAN NECESSITIES
A61M2205/3592
HUMAN NECESSITIES
A61M2016/0036
HUMAN NECESSITIES
A61M2205/3553
HUMAN NECESSITIES
International classification
Abstract
A blower for the treatment of a patient's sleep apnea is disclosed. The blower includes a start/stop button, an air pump, and a processor connected to the start/stop button and air pump. A user may input a sleep period (Tsleep), an ultimate therapeutic pressure (TP) and an acclimation period (Nset). The processor performs an acclimation procedure to ease the patient in to the use of the positive airway pressure (PAP) system over the selected acclimation period.
Claims
1. A blower for the treatment of a patient's sleep apnea, the blower comprising: a start/stop button; an air pump; a processor connected to the start/stop button and air pump, the processor configured to perform an acclimation procedure with the following steps: a. set a sleep period (Tsleep), an ultimate therapeutic pressure (TP), an acclimation period (Nset), and setting a day counter (Nday); b. When the patient presses the start/stop button: i. begin a timer (T); ii. set the air pump to deliver air pressure at a pressure based on ((Nday/Nset)TP); iii. when patient presses start/stop button while performing step (b)(ii): (A) Stop delivering air pressure; (B) Pause T, and (C) If T<Tsleep, then return to step (b). (D) If T>=than Tsleep, and Nset>=Nday, then reset T, increase Nday and return to step (b).
2. The blower of claim 1, wherein the processor is further configured to perform the following steps after (b)(iii)(D): if T>=than Tsleep, and Nset<Nday, then exit acclimation procedure.
3. The blower of claim 1, wherein the processor is further configured to perform the following steps: set a ramp period (Tramp1) and a pre-ramp period (Tpr); step (b)(ii) further comprises: allow Tpr to elapse, then: i. Start a second timer T2 ii. Set the air pump to deliver air pressure at a pressure based on ((Nday/Nset)(T2/Tramp1)TP); iii. When T2>=Tramp1 then set the air pump to deliver air pressure at a pressure based on ((Nday/Nset)TP).
4. The blower of claim 1, wherein the processor sets Tsleep, TP, and Nset based on a user's input.
5. The blower of claim 1, wherein Tsleep is set between 4 and 8 hours.
6. The blower of claim 1, wherein TP is set between 4 and 20 CM H20.
7. The blower of claim 1, wherein Nset is set between 3 and 14 days.
8. The blower of claim 3, wherein the processor sets Tramp and Tpr based on a user's input.
9. The blower of claim 3, wherein either or both of Tramp and Tpr are set between 0.25 and 1.5 hours.
10. The blower of claim 1, further comprising a flow detector connected to the processor and adapted to measure the airflow delivered to the patient, wherein the processor is further configured to perform the following steps: measure the air flow over a first period; measure the air flow over a second period; detect an apnea or hypopnea event based on a deviation between the measured air flows; adjust the TP based on the detected apnea or hypopnea event.
11. A blower for the treatment of a patient's sleep apnea, the blower comprising: a start/stop button; an air pump; a processor connected to the start/stop button and air pump, the processor adapted to perform an acclimation procedure comprised of the following steps: a. receiving a sleep period (Tsleep), an ultimate therapeutic pressure (TP), and an acclimation period (Nset); b. wait for a patient to press the start/stop button, and once pressed setting the set the air pump to deliver air pressure at a pressure based on ((Nday/Nset)TP); c. when the patient presses the start stop button after step (b), determining if: i. Tsleep has elapsed since the patients press of the start/stop button from step (b), if so increment a counter N, stop delivering air pressure and return to step (b); ii. Tsleep has not elapsed since the patients press of the start/stop button from step (b), if so then determine if the day counter N exceeds the acclimation period: i. If so, then stop delivering air pressure and exit acclimation procedure. ii. If not, then stop delivering air pressure and return to step (b).
12. The blower of claim 11, wherein step (a) comprises receiving a ramp period (Tramp1) and a pre-ramp period (Tpr), and step (b) further comprises: allowing Tpr to elapse before delivering air pressure; and when air pressure is delivered it is ramped up to and plateaued at the value of ((Nday/Nset)TP) over Tramp1.
13. The blower of claim 11, wherein the processor receives Tsleep, TP, and Nset based on a user's input.
14. The blower of claim 11, wherein Tsleep is set between 4 and 8 hours.
15. The blower of claim 11, wherein TP is set between 4 and 20 CM H20.
16. The blower of claim 11, wherein Nset is set between 3 and 14 days.
17. The blower of claim 12, wherein the processor receives Tramp1 and Tpr based on a user's input.
18. The blower of claim 12, wherein either or both of Tramp1 and Tpr are set between 0.25 and 1.5 hours.
19. The blower of claim 11, further comprising a flow detector connected to the processor and adapted to measure the airflow delivered to the patient, wherein the processor is further configured to perform the following steps: measure the air flow over a first period; measure the air flow over a second period; detect an apnea or hypopnea event based on a deviation between the measured air flow overs; adjust the TP based on the detected apnea or hypopnea event.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. It will be understood that certain components and details may not appear in the figures to assist in more clearly describing the invention.
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DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0044] Reference is made herein to some specific examples of the present invention, including any best modes contemplated by the inventor for carrying out the invention. Examples of these specific embodiments are illustrated in the accompanying figures. While the invention is described in conjunction with these specific embodiments, it will be understood that it is not intended to limit the invention to the described or illustrated embodiments. To the contrary, it is intended to cover alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.
[0045] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. Particular example embodiments of the present invention may be implemented without some or all of these specific details. In other instances, process operations well known to persons of skill in the art have not been described in detail in order not to obscure unnecessarily the present invention. Various techniques and mechanisms of the present invention will sometimes be described in singular form for clarity. However, it should be noted that some embodiments include multiple iterations of a technique or multiple mechanisms unless noted otherwise. Similarly, various steps of the methods shown and described herein are not necessarily performed in the order indicated, or performed at all in certain embodiments. Accordingly, some implementations of the methods discussed herein may include more or fewer steps than those shown or described. Further, the techniques and mechanisms of the present invention will sometimes describe a connection, relationship or communication between two or more entities. It should be noted that a connection or relationship between entities does not necessarily mean a direct, unimpeded connection, as a variety of other entities or processes may reside or occur between any two entities. Consequently, an indicated connection does not necessarily mean a direct, unimpeded connection unless otherwise noted.
[0046] The following list of example features corresponds with
[0087]
[0088] controls the operation of the blower 20. Many of the methods described herein would be implemented by the blower 20.
[0089] The patient mask designs previously disclosed in the related applications cited above, allows a patient to wear the mask and comfortably breathe when the blower is not delivering pressure. This mask design is a marked difference from the conventional PAP systems that require a continuously open flow path, from the blower to the patient so that the patient's expired breath, which could inadvertently travel into the hose to be re-breathed, is blown free of the hose and is vented into the room through the continuously-leaking vent in the mask or hose assembly. Should a PAP blower fail to provide a continuous flow of positive pressure air, there is a real risk that expired, CO2 laden breath will enter the hose and be re-breathed on the next user inhalation. This is a known condition called CO2 rebreathing, which can have harmful effects on the patient. When CO2 levels are elevated in the body it is known as hypercapnia. Rebreathing CO2 can lead to increased blood pressure, headaches, muscle twitches, rapid heart rate, chest pain, confusion, and fatigue. To mitigate this, users of conventional PAP masks are instructed to wear the mask with the blower set to at least its minimal setting, which is generally 4 [cm H20] in air pressure. A pressure setting of 4 [cm H20] corresponds to a typical continuous venting flow rate of 20 [lpm].
[0090] Engineering testing of the patient mask designs previously disclosed in the related applications cited above has shown particularly favorable results in reducing the accumulation of CO2 in the mask and airway. Testing has been conducted in accordance with a standard: ISO 17510_2015 Medical Devices-Sleep apnoea breathing therapyMasks and application accessories Therapy Annex F CO2 Rebreathing. Testing revealed that in one of the worst case test conditions, with the blower off and the hose detached from the blower, the increase in intra-mask CO2 with the FRESCA embodiment was only 8-11%. This is considered a worst case condition for two reasons: 1) it is a configuration in which there is no airflow being delivered through the hose to flush out expired breath and 2) the hose is open at the farthest end from the patient which promotes migration of a patient's breath down the hose.
[0091] This testing confirms that the acclimation and snooze method described herein can be best utilized with the previously disclosed mask designs because the methods optimally have a period of zero pressure from the blower before any pressure is delivered. This is simply not possible with conventional PAP systems.
6.1 Acclimation Method for Use in Pap System
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[0093] The curves also show an acclimation sleep period (Tsleep) 227, which is used to confirm that the patient has experienced enough of the therapy period 235 for a particular day, such that the system can then increase the daily pressure for the next day. If, for example, the patient turns off the blower before Tsleep has elapsed on day 3, then the system will implement the same pressure for day 3 on day 4 until enough time has accrued to count as one complete Tsleep period. Alternatively, the system will only count days during which Tsleep has been achieved against the acclimation period.
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[0095] The method 1000 then sets a day counter to 1 at step 1020 and waits for the patient to press start at step 1025. Once the patient presses start, the timer (T) is started and the air pump is set at the daily therapeutic pressure (TPdaily) defined as (Nday/Nset)TP (steps 1030, 1040 and 1042. If the patient presses stop, the method pauses the timer T, and determines if the timer exceeds the acclimation sleep period (Tsleep) (steps 1050, 1055 and 1060). If it does exceed, the day counter (Nday) is incremented (step 1080) and the method determines if the entire acclimation period (Nset) has been reached (step 1065). If the acclimation period has been reached, then the acclimation method is exited at step 1070. If however, the acclimation period has not yet been reach, then the method resets the timer (T) (step 1075) and returns to waiting for the patient to press start (step 1025).
[0096] If back at step 1060, the timer does not exceed the acclimation sleep period (Tsleep), then the method may or may not reset the timer (step 1074) and does not increment the day counter (Nday), but does return to waiting for the patient to press start (step 1025). By not increasing the day counter (Nday), the patient does not get credit for the previous day's use of the PAP because the patient did not use it long enough. Also, if the method includes the optional timer (T) reset in step 1074, each time the patient shorts the acclimation sleep period (Tsleep), he will have to start over in order to have sufficient time to count the day against the acclimation period (Nset). This, however, may not be advantageous to progressing patients through the acclimation procedure; so instead the optional step 1074 may be omitted. This would then provide the patient credit for PAP time used in a previous session that did not achieve Tsleep. So for example, if in day 4 the patient uses the PAP system for 5 hours and Tsleep is set for 6 hours, then the method will not increment the day counter (Nday). However, the patient upon restarting the PAP system the next day will begin the timer at 5 hours and at the same daily therapeutic pressure (TPdaily) as the previous day, but will need only one additional hour to increment in to the next day in the acclimation period.
[0097] The acclimation method 1000 may optionally have a ramp up feature 1031 and pre-ramp period as shown graphically in
[0098] A processor implementing the acclimation method 1000 may set Tsleep, TP, Nset, Tramp1, and Tpr based on the user's (e.g. patient or physician) input. Optimal values for Tsleep is between 4 and 8 hours, for TP is between 4 and 20 CM H20, for Nset is between 3 and 14 days, and for either or both of Tramp1 and Tpr is between 0.25 and 1.5 hours. And as discussed below, the processor may adjust TP based on predicted patient breathing patterns.
[0099] It should be noted that there are a multitude of acclimation scenarios that can be contemplated, including a series of nights where the pressure does not increase.
[0100] It is possible to apply the system as described above at non-therapeutic pressure settings due to the nature of sleep apnea. It is a chronic condition that is often untreated for months or years. Using a period of days or weeks to allow an acclimation period is an acceptable trade off if it allows the user to be more compliant with or tolerant of the needed chronic therapy. The risks associated with PAP treatment are generally considered long-term, accumulated risks, so it has been found generally acceptable to sacrifice some minor part of efficacy in return for better, sustained long-term compliance.
6.2 Snooze Method for Use in Pap System
[0101] The patient mask designs previously disclosed in the related applications cited above system can be worn with the blower in an off condition without the risk of CO2 rebreathing. Additionally, it is disclosed that the user can wear the system while awake and going to sleep with the blower in an off condition, set to activate spontaneously after a set period of time or after detecting the user has fallen asleep based on monitoring the breath rate, tidal volume, or both. The concept of having the blower in the off condition can be expanded to allow the user to snooze the system by activating a snooze feature. The intention of this feature is to allow the user to re-enter the mode of the blower in an off condition if he or she wakes sometime during the night and wishes to return to initiate sleeping in the more comfortable mode of operation. This could also be useful for patients who find that they have to utilize the restroom one or more times during the night, and would like to return to sleep comfortably using a blower off condition for a pre-specified period, such as 5 to 10 minutes. This would be different from the ramp, as it would allow the user to return to therapy more quickly than the ramp, yet still provide the comfort benefit of the blower off condition while returning to sleep. The snooze feature would have user-specified or pre-set time periods for return to full therapeutic pressure.
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[0103] When the patient has either slept long enough, the blower 20 may disable snooze transition out of the snooze configuration as shown in
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[0107] The method 2000 waits for the patient to press the start/stop button at step 2016. After such a press, the method 2000 set a counter N to 0 (step 2018) to monitor that the patient has not exceed the maximum number of snooze triggers (Nmax). This counter N may be set at the initiation stage of the method (i.e., prior to step 2016). The pre-snooze period (Tps) is allowed to elapse (steps 2020, 2022) as is the snooze period (Tsnooze) (steps 2026, 2028). Steps 2032 through 2040 gradually ramp up the blower pressure over the ramp period (Tramp1) until it plateaus at the therapeutic pressure TP.
[0108] If the patient has used the blower a sufficient amount of time (i.e., Tds), then the method disables the snooze function (steps 2042 and 2044). Any press of the blower buttons subsequent to this is considered an intention to turn off the blower (steps 2046, 2048). These two states (i.e., prior to Tds and after) are shown in
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[0111] It should be noted that in the even the patient has exceeded the maximum number of triggers Nmax, then the method effectively ignores the patients snooze trigger (see 2052, 2062, 2082). This state is illustrated in
[0112] A processor implementing the snooze method 2000 may set Tsnooze, Tramp1, Tramp2, Tds, Tps, TP and Nmax based on the user's (e.g. patient or physician) input. Optimal values for Tsnooze, Tramp 1, Tramp 2 and Tps is between 0.1 and 1.5 hours, for Tds is between 4 and 8 hours, TP is between 4 and 20 CM H20, for Nmax is between 3 and 6. And as discussed below, the processor may adjust TP based on predicted patient breathing patterns.
6.3 Acclimation and Snooze Method for Use in Pap System
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[0114] Steps 3005 and 3010 set the day counter (Nday) and an acclimation period (Nset). In steps 3015, 3020 and 3040, the blower is set to a pressure that is reduced by the fraction of (Nday/Nset) from the previous snooze only method. If the snooze period is exceeded (step 2042) then the method will also increment the day counter Nday (step 3025) and check if the acclimation setting should be exited in steps 3030 and 3035.
[0115] Finally, the therapeutic pressure (TP) described above need not be static, but may change with treatment efficacy. If, for example, the patient is not experiencing an apnea or hypopnea (shallow breathing) event while on the current TP, then the system may reduce the TP, thus providing more comfort to the patient. Conversely, if under the current TP the patient still experiences apnea or hypopnea, then the system could increase the TP. The blower box 20 may have a flow sensor 33 connected to the processor 31 (See
[0116] To illustrate, the TP may be set for the snooze method at 12 CM H20. If the processor 31 detects that over the course of several hours that no event has occurred, the processor 31 may lower the TP to 10 CM H20 and again monitor the patient breathing patterns. If, however the processor 31 detects an apnea event, then it may increase the TP to 15 CM H20 and continuing monitoring. Likewise, a hypopnea event may cause the processor 31 to increase the TP, but perhaps not as severe as an apnea event. The processor 31 may periodically adjust the TP to arrive at the minimum necessary TP to prevent detected events. U.S. application Ser. No. 15/334,243 filed Oct. 15, 2016 titled Apparatus, Systems, and Methods For Treating Obstructive Sleep Apnea, incorporated herein by reference, includes an additional description of techniques and structures that may be used to detect apnea of hypopnea, and this can be used by the processor to adjust TP.
[0117] Various settings have been described as selectable by the user (patient or physician). These may be set at the time of prescription of the device. They may be set periodically such as nightly. Some settings, such as TP may be configured to be only selectable and settable by the physician. Settings may be adjusted through the touchscreen of the blower, reprogramming by inserting of a memory card in the card reader with software updates, and even through remote control such as Bluetooth interaction with a portable phone and dedicated application. These functions may be implemented using the card reader 34A and the antenna/transceiver 34B shown in
[0118] Although exemplary embodiments and applications of the invention have been described herein including as described above and shown in the included example Figures, there is no intention that the invention be limited to these exemplary embodiments and applications or to the manner in which the exemplary embodiments and applications operate or are described herein. Indeed, many variations and modifications to the exemplary embodiments are possible as would be apparent to a person of ordinary skill in the art. The invention may include any device, structure, method, or functionality, as long as the resulting device, system or method falls within the scope of one of the claims that are allowed by the patent office based on this or any related patent application.