JPWO2021176426A5

JPWO2021176426A5 -

Info

Publication number: JPWO2021176426A5
Application number: JP2022553698A
Authority: JP
Publication date: 2023-05-25
Anticipated expiration: 2041-03-05

Description

図１は、本開示の一部の実装による、睡眠セッションの睡眠に関連する１つまたは複数のパラメータを決定するシステムの機能ブロック図である。FIG. 1 is a functional block diagram of a system for determining one or more sleep-related parameters of a sleep session, according to some implementations of the present disclosure. 図２は、本開示の一部の実装による、図１のシステムの少なくとも一部の斜視図、ユーザー、およびベッドパートナーである。FIG. 2 is a perspective view of at least a portion of the system of FIG. 1, a user and a bed partner, according to some implementations of the present disclosure; 図３Ａは、本開示の一部の実装による、睡眠中の個人の呼吸波形を示す。FIG. 3A shows an individual's respiratory waveform during sleep, according to some implementations of the present disclosure. 図３Ｂは、本開示の一部の実装による、約９０秒間にわたって正常に呼吸している非レム睡眠中の個人の選定睡眠ポリグラフチャネル（パルスオキシメトリ、流量、胸郭運動、および腹部運動）を示す。FIG. 3B shows selected polysomnographic channels (pulse oximetry, flow, chest motion, and abdominal motion) of an individual during non-REM sleep who is breathing normally for approximately 90 seconds, according to some implementations of the present disclosure. . 図３Ｃは，本開示の一部の実装による、呼吸治療前の個人の睡眠ポリグラフを示す。FIG. 3C shows an individual's polysomnography prior to respiratory therapy, according to some implementations of the present disclosure. 図３Ｄは、本開示の一部の実装による、個人が一連の完全閉塞性無呼吸を経験している時の流量データを示す。FIG. 3D shows flow data when an individual is experiencing a series of total obstructive apneas, according to some implementations of the present disclosure. 図４Ａは、本開示の一部の実装による、呼吸療法装置のユーザーに関連する流量データを示す。FIG. 4A illustrates flow data associated with a user of a respiratory therapy device, according to some implementations of the present disclosure. 図４Ｂは、本開示の一部の実装による、呼吸療法装置のユーザーに関連する圧力データを示す。FIG. 4B shows pressure data associated with a user of a respiratory therapy device, according to some implementations of the present disclosure. 図４Ｃは、本開示の一部の実装による、呼気圧力軽減モジュールを有する呼吸療法装置のユーザーに関連する圧力データを示す。FIG. 4C shows pressure data associated with a user of a respiratory therapy device having an expiratory pressure relief module, according to some implementations of the present disclosure. 図５Ａは、本開示の一部の実装による、平均デバイス圧力およびリットル／分で表される平均総流量をプロットしたデカルト座標を示す。FIG. 5A shows Cartesian coordinates plotting average device pressure and average total flow in liters/minute, according to some implementations of the present disclosure. 図５Ｂは、本開示の一部の実装による、図５Ａのプロットされたデカルト座標上に当てはめられた特性曲線を示す。FIG. 5B shows a characteristic curve fitted over the plotted Cartesian coordinates of FIG. 5A, according to some implementations of the present disclosure. 図６は、本開示の一部の実装による、ユーザーに関連する呼吸療法装置の意図的リーク特性曲線を示す。FIG. 6 illustrates an intentional leak characteristic curve for a respiratory therapy device associated with a user, according to some implementations of the present disclosure. 図７は、本開示の一部の実装による、呼吸療法装置の意図的リーク特性曲線を検出する方法の流れ図である。FIG. 7 is a flow diagram of a method for detecting an intentional leak characteristic curve of a respiratory therapy device, according to some implementations of the present disclosure; 図８は、本開示の一部の実装による、呼吸療法装置の意図的リーク特性曲線を決定する方法の流れ図を示している。FIG. 8 illustrates a flow diagram of a method of determining an intentional leak characteristic curve for a respiratory therapy device, according to some implementations of the present disclosure. 図９は、本開示の一部の実装による、呼吸療法下の呼吸中の流量（「Ｑ」）データおよび流容量（「Ｖ」）データを示す。FIG. 9 shows flow (“Q”) and flow-volume (“V”) data during breathing under respiratory therapy, according to some implementations of the present disclosure. 図１０は、本開示の一部の実装による、呼吸療法下での２回の呼吸中の流量（レート）データおよび流容量データを示す。FIG. 10 shows flow (rate) and flow volume data during two breaths under respiratory therapy, according to some implementations of the present disclosure. 図１１は、開示の一部の実装による、圧力値（「Ｐ」；ｃｍＨ_２Ｏ）対流量値（「Ｑ」；１０秒当たりのリットル）の散布図に当てはめられた意図的リーク特性曲線を示す。FIG. 11 illustrates an intentional leak characteristic curve fitted to a scatter plot of pressure values (“P”; cmH ₂ O) versus flow values (“Q”; liters per 10 seconds), according to some implementations of the disclosure. show. 図１２は、本開示の一部の実装による、意図的リーク特性アルゴリズムに影響を与える４つのタイプのインピーダンス（Ｚ１、Ｚ２、Ｚ３、およびＺ４）を示す。FIG. 12 illustrates four types of impedance (Z1, Z2, Z3, and Z4) that affect the intentional leak characterization algorithm, according to some implementations of the present disclosure.

流量センサー１３４は、メモリ装置１１４に保存することができ、かつ／または制御システム１１０のプロセッサ１１２によって分析することができる流量データを出力する。流量センサー（例えば、流量センサー１３４など）の例は、国際公開ＷＯ２０１２／０１２８３５に記載されており、その全体が参照により本明細書に組み込まれる。一部の実装形態では、流量センサー１３４は、呼吸治療デバイス１２２からの空気流量、導管１２６を通る空気流量、ユーザーインターフェース１２４を通る空気流量、またはそれらの任意の組み合わせを決定するために使用される。そのような実装では、流量センサー１３４は、呼吸療法デバイス１２２、ユーザーインターフェース１２４、または導管１２６に結合または統合することができる。流量センサー１３４は、例えば、回転流量計（例えば、ホール効果流量計）、タービン流量計、オリフィス流量計、超音波流量計、熱線センサー、渦センサー、膜センサーなどの質量流量センサー、またはそれらの任意の組み合わせであり得る。一部の実装形態では、流量センサー１３４は、通気流量（例えば、意図的な「リーク」）、意図しないリーク（例えば、口漏れおよび／またはマスク漏れ）、患者の流れ（例えば、肺へのおよび／または肺からの空気の流出入）、またはこれらの組合せを測定するように構成される。一部の実装形態では、流量データを分析して、ユーザーの心原性振動を判断することができる。一例では、圧力センサー１３２を使用して、ユーザーの血圧を判断することができる。 Flow sensor 134 outputs flow data that can be stored in memory device 114 and/or analyzed by processor 112 of control system 110 . Examples of flow sensors (eg, flow sensor 134, etc.) are described in International Publication WO2012/012835, which is incorporated herein by reference in its entirety. In some implementations, flow sensor 134 is used to determine airflow from respiratory therapy device 122, airflow through conduit 126, airflow through user interface 124, or any combination thereof. . In such implementations, flow sensor 134 may be coupled or integrated into respiratory therapy device 122 , user interface 124 , or conduit 126 . The flow sensor 134 may be a mass flow sensor such as, for example, a rotary flow meter (e.g., a Hall effect flow meter), a turbine flow meter, an orifice flow meter, an ultrasonic flow meter, a hot wire sensor, a vortex sensor, a membrane sensor, or any thereof. can be a combination of In some implementations, the flow sensor 134 measures ventilation flow (e.g., intentional “leaks”), unintended leaks (e.g., mouth and/or mask leaks), patient flow (e.g., pulmonary and and/or air inflow and outflow from the lungs), or a combination thereof. In some implementations, the flow data can be analyzed to determine the user's cardiogenic oscillations. In one example, pressure sensor 132 can be used to determine the user's blood pressure.

ステップ８２０で、ユーザーの最初の呼吸に関連する第１の時間と、ユーザーの第２の呼吸に関連する第２の時間が識別される。一部の実装形態では、第１の時間および第２の時間は、複数の流量値の少なくとも一部の複数の流量値に対応する複数の流容量値を分析することによって識別することができる。一部の実装形態では、複数の対応する流容量値は、複数の流量値の少なくとも一部の時間積分をとることによって決定される。ユーザーの最初の呼吸に関連する最初の時間を識別する例示的な方法が、図９に示されている。２回目も同じまたは類似の方法で識別できる。 At step 820, a first time associated with the user's first breath and a second time associated with the user's second breath are identified. In some implementations, the first time and the second time can be identified by analyzing a plurality of flow capacity values corresponding to at least a portion of the plurality of flow rate values . In some implementations, the plurality of corresponding flow capacity values is determined by taking a time integral of at least a portion of the plurality of flow values . An exemplary method of identifying the first time associated with the user's first breath is shown in FIG. A second time can be identified in the same or similar manner.

ステップ８３０において、複数の流量値は、識別された第１の時間および識別された第２の時間に少なくともある程度基づいてフィルタリングされる。次いで、フィルタリングは、複数の流量値のサブセットを生成する。一部の実装形態では、複数の流量値のサブセットは、受信した複数の流量値の１％以下を含む場合がある。加えて、または代替として、一部の実装形態では、複数の流量値のサブセットは、（ｉ）最初の呼吸の１、２、３、４、または５つの流量値、および（ｉｉ）２回目の呼吸の１、２、３、４、または５つの流量値を含む。例えば、複数の流量値のサブセットは、（ｉ）最初の呼吸の吸入の開始付近での１つ、２つ、３つ、４つ、または５つの流量値、および（ｉｉ）２番目の呼吸の吸入の開始付近での１つ、２つ、３つ、４つまたは５つの流量値を含む。 At step 830, the plurality of flow values are filtered based at least in part on the identified first time and the identified second time. Filtering then produces a subset of flow values . In some implementations, the subset of flow values may include 1% or less of the received flow values . Additionally or alternatively, in some implementations, the subset of multiple flow values is (i) 1, 2, 3, 4, or 5 flow values of the first breath and (ii) Contains 1, 2, 3, 4, or 5 flow values for breath. For example, the subset of flow values may be (i) 1, 2, 3, 4, or 5 flow values near the onset of inhalation of the first breath and (ii) Includes 1, 2, 3, 4 or 5 flow values near the beginning of inspiration.

一部の実装形態では、複数の流量値がローパスフィルタでフィルタリングされ、純粋にＤＣである（たとえば、ユーザーの呼吸を含まない、および／またはその影響を受けない）複数の流量値のサブセットが生成される。ＤＣ値は平均値であり得る。ローパスフィルタは高い周波数を除去し、低い周波数を残すため、平均値となる。例えば、一部の実装形態では、ローパスフィルタでは、最初に流容量値を分析して、ユーザーの最初の呼吸に関連する最初の時間を特定し、次にユーザーの２番目の呼吸に関連する２番目の時間を特定する（ステップ８２０）。しかしながら、開示された方法では、ユーザーの最初の呼吸に関連する第１の時間と、ユーザーの第２の呼吸に関連する第２の時間を特定するための任意の適切なフィルタリングを使用することがある。 In some implementations, the plurality of flow values are filtered with a low-pass filter to produce a subset of the plurality of flow values that are purely DC (e.g., not including and/or affected by the user's breathing). be done. DC values can be mean values. A low-pass filter removes the high frequencies and leaves the low frequencies, resulting in an average value. For example, in some implementations, the low pass filter first analyzes the flow capacity values to identify the first time associated with the user's first breath, then the second time associated with the user's second breath. th time is identified (step 820). However, the disclosed method can use any suitable filtering to identify the first time associated with the user's first breath and the second time associated with the user's second breath. be.

図９を参照すると、本開示の一部の実装による、呼吸療法下の最初の呼吸中の流量データ（「Ｑ」）および流容量データ（「Ｖ」）が示されている。プロット９００は、呼吸療法装置のユーザーの最初の呼吸９８０を示している。一部の実装形態では、ユーザーの各呼吸は、息を吸う部分と息を吐く部分を含む。示されるように、第１の呼吸９８０は、息を吸う部分９８２および息を吐く部分９８４を含む。プロット９００の上部セクション９０２は、最初の呼吸９８０におけるユーザーに関連する流量データ９１０（破線）を示す。プロット９００の下部セクション９０４は、対応する流容量データ９５０（破線）を示す。一部の実施形態では、対応する流容量データ９５０は、流量データ９１０の時間積分をとることによって決定することができる。 Referring to FIG. 9, flow data (“Q”) and flow volume data (“V”) during the first breath under respiratory therapy are shown, according to some implementations of the present disclosure. Plot 900 shows the first breath 980 of a respiratory therapy device user. In some implementations, each breath of the user includes an inhalation portion and an exhalation portion. As shown, a first breath 980 includes an inhale portion 982 and an exhale portion 984 . The top section 902 of plot 900 shows flow data 910 (dashed line) associated with the user in first breath 980 . A lower section 904 of plot 900 shows corresponding flow capacity data 950 (dashed line). In some embodiments, corresponding flow volume data 950 can be determined by taking the time integral of flow data 910 .

流容量データを使用して、ユーザーの最初の呼吸に関連する最初の時間と、ユーザーの２番目の呼吸に関連する２番目の時間を特定することができる（たとえば、方法８００のステップ８２０）。そしてこれを意図的リーク特性曲線の決定のために利用できる（例えば、方法８００のステップ８４０）。一部の実施形態では、第１の時間は第１の呼吸の息を吸う部分内にあり、第２の時間は第２の呼吸の息を吸う部分内にある。 The flow-volume data can be used to identify a first time associated with the user's first breath and a second time associated with the user's second breath (eg, step 820 of method 800). This can then be used for determination of the intentional leak characteristic curve (eg, step 840 of method 800). In some embodiments, the first time is within the inhale portion of the first breath and the second time is within the inhale portion of the second breath.

一部の実装形態では、第１の時間はユーザーの最初の呼吸が始まったときであり、第２の時間はユーザーの２回目の呼吸が始まったときとする。追加または代替として、一部の実装形態では、第１の時間は、最初の呼吸の息を吸い始める辺り、第２の時間は、２番目の呼吸の息を吸い始める辺りである。図９に示すこの例では、第１の時間は、流量データ９１０の流量９１２および流容量データ９５０の流容量９５２に対応している。流容量９５２は、最初の呼吸９８０中の最小流容量値である。 In some implementations, the first time is when the user's first breath begins and the second time is when the user's second breath begins. Additionally or alternatively, in some implementations, the first time is around the beginning of the inhalation of the first breath and the second time is around the beginning of the inhalation of the second breath. In this example shown in FIG. 9, the first time corresponds to flow rate 912 of flow data 910 and flow capacity 952 of flow capacity data 950 . Flow volume 952 is the minimum flow volume value during first breath 980 .

そのような実装形態の一部では、第１の呼吸９８０の最小流容量値（例えば、流容量９５２）は、第１の呼吸９８０の開始時および／または第１の呼吸９８０の息を吸う部分９８２の開始時に対応する。したがって、第１の時間は、流容量データ９５０を分析して最小流容量値を見つけることによって特定することができる。第１の呼吸９８０の最小流容量値（例えば、流容量９５２）は流量９１２にも対応するが、これは吸気の開始時の流量である（Ｑ＝「ゼロ」流量が図９に水平線９０６として示されている）。 In some such implementations, the minimum flow volume value (eg, flow volume 952) of first breath 980 is at the beginning of first breath 980 and/or the inspiratory portion of first breath 980. 982 start time. Accordingly, the first time can be identified by analyzing flow capacity data 950 to find the minimum flow capacity value. The minimum flow volume value (e.g., flow volume 952) for first breath 980 also corresponds to flow 912, which is the flow at the beginning of inspiration (Q=“zero” flow is shown as horizontal line 906 in FIG. 9). It is shown).

一部の実装形態では、第１の時間は第１の呼吸の息を吐く部分内にあり、第２の時間は第２の呼吸の息を吐く部分内にある。追加または代替として、一部の実装形態では、第１の時間は最初の呼吸の息を吐く部分の開始時辺りであり、第２の時間は２回目の呼吸の息を吐く部分の開始時辺りである。図９に示すこの例では、第１の時間は、流量データ９１０の流量９１４および流容量データ９５０の流容量９５４に対応している。流容量９５４は、最初の呼吸９８０中の最大流容量値である。 In some implementations, the first time is within the exhale portion of the first breath and the second time is within the exhale portion of the second breath. Additionally or alternatively, in some implementations, the first time is around the start of the exhale portion of the first breath and the second time is around the start of the exhale portion of the second breath. is. In this example shown in FIG. 9, the first time corresponds to flow rate 914 of flow data 910 and flow capacity 954 of flow capacity data 950 . Flow volume 954 is the maximum flow volume value during first breath 980 .

そのような実装形態の一部では、第１の呼吸９８０の最大流容量値（例えば、流容量９５４）は、第１の呼吸９８０の息を吐く部分９８４の開始時に対応する。したがって、第１の
時間は、流容量データ９５０を分析して最大流容量値を見つけることによって特定することができる。第１の呼吸９８０の最大流容量値（例えば、流容量９５４）は、流量９１４にも対応し、これは「ゼロ」流量（すなわち、ユーザーの呼吸サイクルにおける息を吸って息を吐く間のある時点での流量）である。 In some such implementations, the maximum flow volume value (eg, flow volume 954 ) of first breath 980 corresponds to the beginning of exhalation portion 984 of first breath 980 . Accordingly, the first time can be identified by analyzing the flow capacity data 950 to find the maximum flow capacity value. The maximum flow capacity value (e.g., flow capacity 954) for first breath 980 also corresponds to flow rate 914, which is the "zero" flow rate (i.e., the amount of time between inhalation and exhalation in the user's breathing cycle). flow rate at the point in time).

流量がゼロの時間を特定することは、交絡呼吸信号が除外されるため（つまり、流量がゼロではない場合）、好都合な場合がある。しかしながら、ユーザーが意図しない漏れ（例えば、口からの漏れ）を経験している例では、呼吸の終わりに流量がゼロに戻らないことがある。この図９の例では、最初の呼吸９８０の終わりに、流量９１６は「ゼロ」流量に戻っていない。対照的に、ユーザーが意図しない漏れを経験していない場合、流量データ９３０は、最終流容量が「ゼロ」に戻ることを示す。 Identifying the time of zero flow may be advantageous because confounding respiratory signals are filtered out (ie, non-zero flow). However, in instances where the user is experiencing unintended leakage (eg, mouth leakage), the flow may not return to zero at the end of the breath. In this FIG. 9 example, at the end of the first breath 980, flow 916 has not returned to "zero" flow. In contrast, if the user is not experiencing an unintended leak, the flow data 930 will show the final flow capacity returning to "zero."

第１の呼吸９８０の意図しない漏れの存在および／または量を決定するために、第１の呼吸９８０の終了時に関連する最終流容量９５６を、第１の呼吸９８０の開始時に関連する流容量９５２と比較することによって、流容量データを分析することができる。この比較に少なくともある程度基づいて、ユーザーが最初の呼吸９８０中に意図しない漏れ（例えば、ユーザーの口からの空気漏れを示す口漏れ）を経験しているかどうかを決定することができる。終了流容量９５６が開始流容量９５２よりも大きければ、ユーザーが最初の呼吸９８０中に意図しない漏れを経験していることを示している。ユーザーが最初の呼吸９８０中に意図しない漏れを経験しているという決定に対し、呼吸療法装置の意図的リーク特性曲線を決定する際に最初の呼吸９８０を除外することができる（図８のステップ８４０）。 To determine the presence and/or amount of unintended leakage of the first breath 980, the associated final flow volume 956 at the end of the first breath 980 and the associated flow volume 952 at the beginning of the first breath 980 are measured. The flow volume data can be analyzed by comparing with . Based at least in part on this comparison, it can be determined whether the user is experiencing unintended leakage during the first breath 980 (eg, mouth leakage indicating air leakage from the user's mouth). If the ending flow volume 956 is greater than the starting flow volume 952, it indicates that the user is experiencing unintended leakage during the first breath 980. Upon determination that the user is experiencing an unintentional leak during the first breath 980, the first breath 980 can be excluded in determining the respiratory therapy device's intentional leak characteristic curve (step 840).

追加または代替として、一部の実装形態では、流容量データを分析することによって、最初の呼吸９８０中の意図しない漏れの量を決定することができる。この図の例では、図９の例では、流容量データ９５０と参照データ９７０との間の面積差９７２は、最初の呼吸９８０中の意図しない漏れの量を示している。息を吸う部分９８２に関しては、参照データ９７０は流容量データ９５０と一致するため、ユーザーは息を吸う部分９８２中に意図しない漏れを経験しない可能性が高い。息を吐く部分９８４については、参照データ９７０は、最大流容量９５４から最終流容量９５６までの直線としてプロットする。面積差９７２は、参照データ９７０における流容量値の第２の時間積分から流容量データ９５０における流容量値の第１の時間積分を差し引くことによって計算することができる。 Additionally or alternatively, in some implementations, the amount of unintended leakage during the first breath 980 can be determined by analyzing the flow volume data. In the example of this figure, in the example of FIG. 9, the area difference 972 between the flow volume data 950 and the reference data 970 indicates the amount of unintended leakage during the first breath 980. For the inhale portion 982 , the reference data 970 matches the flow rate data 950 so that the user is unlikely to experience unintentional leakage during the inhale portion 982 . For exhale portion 984 , reference data 970 plots as a straight line from maximum flow volume 954 to final flow volume 956 . The area difference 972 can be calculated by subtracting the first time integral of the flow capacity value in the flow capacity data 950 from the second time integral of the flow capacity value in the reference data 970 .

方法８００（図８）の１つまたは複数のステップを実施する別の例として、図１０に、本開示の一部の実装による、呼吸療法下での２回の呼吸中の流量データおよび流容量データを示す。プロット１０００の上部は、流量対時間を示す。プロット１０００の下部は、対応する流容量対時間を示している。流容量データ１０５０は、流量データ１０１０の時間積分をとることによって計算することができる。流量データ１０１０および流容量データ１０５０は、２回の呼吸にわたってプロットされる。第１の呼吸は、第１の息を吸う部分１０８２および第１の息を吐く部分１０８４を含む。第２の呼吸は、第２の息を吸う部分１０８６および第２の息を吐く部分１０８８を含む。 As another example of implementing one or more steps of method 800 (FIG. 8), FIG. 10 shows flow data and volume during two breaths under respiratory therapy, according to some implementations of the present disclosure. Show data. The top of plot 1000 shows flow rate versus time. The lower portion of plot 1000 shows the corresponding flow capacity versus time. Flow volume data 1050 can be calculated by taking the time integral of flow data 1010 . Flow data 1010 and flow-volume data 1050 are plotted over two breaths. The first breath includes a first inhale portion 1082 and a first exhale portion 1084 . The second breath includes a second inhale portion 1086 and a second exhale portion 1088 .

図１０のこの例では、流量１０１２と流容量１０５２は第１の時間に相当する。流量１０１６と流容量１０５６は第２の時間に相当する。したがって、第１の時間は、ユーザーの最初の呼吸が始まったときであり、第２の時間は、ユーザーの第２の呼吸が始まったときである。加えて、または代替として、第１の時間は第１の呼吸の息を吸う部分１０８２の開始時辺りであり、第２の時間は第２の呼吸の息を吸う部分１０８６の開始時辺りである。さらに追加的または代替的に、第１の時間は第１呼吸の最小流容量値に対応し、第２の時間は第２呼吸の最小流容量値に対応する。 In this example of FIG. 10, flow rate 1012 and flow volume 1052 correspond to the first time. Flow rate 1016 and flow volume 1056 correspond to a second time. Thus, the first time is when the user's first breath begins and the second time is when the user's second breath begins. Additionally or alternatively, the first time is about the beginning of the inhale portion 1082 of the first breath and the second time is about the beginning of the inhale portion 1086 of the second breath. . Additionally or alternatively, the first time corresponds to a minimum flow capacity value for the first breath and the second time corresponds to a minimum flow capacity value for the second breath.

図１１を参照すると、散布図１１００（圧力対流量）に当てはめられた意図的リーク特
性曲線が示されており、本書で開示する方法の１つまたは複数のステップ、方法８００のステップ８４０などを実装することがある。Ｘ軸は流量値（「Ｑ」、１０秒あたりのリットル）を表し、Ｙ軸は圧力値（「Ｐ」、ｃｍＨ_２Ｏ）を表す。呼吸ごとに、第１のＸ値と第１のＹ値を持つデカルト座標が、散布点１１００内の点としてプロットされる。第１デカルト座標の第１のＸ値は、第１時間（方法８００のステップ８２０で識別される）に対応する第１流量値である。第１のデカルト座標の第１のＹ値は、第１の時間（方法８００のステップ８２０で識別される）に対応する第１の圧力値である。後続のデカルト座標は、最初のデカルト座標と同じまたは同様の方法でプロットされる。次に、意図的なリーク特性曲線１０２０を散布点１１００に当てはめる。 Referring to FIG. 11, there is shown an intentional leak characteristic curve fitted to a scatter plot 1100 (pressure vs. flow ) implementing one or more steps of the methods disclosed herein, such as step 840 of method 800. I have something to do. The X-axis represents flow values (“Q”, liters per 10 seconds) and the Y-axis represents pressure values (“P”, cmH ₂ O). For each breath, the Cartesian coordinates with the first X value and the first Y value are plotted as points within the scatter points 1100 . The first X value of the first Cartesian coordinate is the first flow value corresponding to the first time (identified at step 820 of method 800). The first Y value of the first Cartesian coordinate is the first pressure value corresponding to the first time (identified at step 820 of method 800). Subsequent Cartesian coordinates are plotted in the same or similar manner as the first Cartesian coordinate. An intentional leak characteristic curve 1020 is then fitted to the scatter points 1100 .

Claims

A method for determining an intentional leak characteristic curve for a respiratory therapy device, comprising:
the computer
receiving a plurality of flow values associated with pressurized air directed to an airway of a user of the respiratory therapy device;
receiving a plurality of pressure values corresponding to each of the plurality of flow values associated with pressurized air directed into the user's airway;
identifying a first time associated with a first breath of the user and identifying a second time associated with a second breath of the user to which the first time corresponds to a position within the breathing cycle ;
filtering the plurality of flow values based at least in part on the identified first time and the identified second time, filtering to generate a subset of the plurality of flow values;
determining an intentional leak characteristic curve of the respiratory therapy device using at least two of the subsets of the plurality of flow values and pressure values corresponding to at least two of the subsets of the flow values;
including a method

determining the intentional leak characteristic curve of the respiratory therapy device;
a first Cartesian coordinate having a first X value that is a first flow value corresponding to said first time and a first Y value that is a first pressure value corresponding to said first time; generating;
a second Cartesian coordinate having a second X value that is a second flow value corresponding to said second time and a second Y value that is a second pressure value corresponding to said second time; generating;
determining an intentional leak characteristic curve based at least in part on the first generated Cartesian coordinate and the second generated Cartesian coordinate;
2. The method of claim 1, comprising:

3. The method of claim 1 or claim 2, wherein the intentional leak characteristic curve is calculated using the following formula:
Z=P/Q= _k1Q + _k2
where Z is an intentional leak characteristic curve, P is a pressure value among multiple pressure values, Q is a flow rate value among multiple flow values, _k1 is a first constant, and _k2 is a second constant. is.

determining at least a portion of the plurality of flow rate values and a plurality of corresponding flow capacity values ;
The method according to any one of claims 1-3.

said first time period associated with said first breath of a user and said second time period associated with said second breath of a user are at least partially analyzed for a determined plurality of corresponding flow-capacity values; 5. The method of claim 4, wherein the identification is based on.

6. A method according to claim 4 or claim 5, wherein a corresponding plurality of flow capacity values are determined by taking a time integral of at least a portion of said plurality of flow values.

A method according to any preceding claim, wherein each breath of the user comprises an inhalation portion and an exhalation portion.

8. The method of claim 7, wherein the first time period is within the inhale portion of the first breath and the second time period is within the inhale portion of the second breath.

8. Claim 7 or claim 7, wherein the first time is about the beginning of the inhale portion of the first breath and the second time is about the beginning of the inhale portion of the second breath. 8. The method according to 8.

10. The first time period corresponds to the first breath minimum flow capacity value and the second time period corresponds to the second breath minimum flow capacity value. The method described in .

8. The method of claim 7, wherein the first time period is within the exhale portion of the first breath and the second time period is within the exhale portion of the second breath.

12. The method of claim 11, wherein the first time is about the beginning of the exhalation portion of the first breath and the second time is about the beginning of the exhalation portion of the second breath. Method.

A first flow value corresponding to the first time is equal to an initial flow value at the beginning of the first breath, and a second flow value corresponding to the second time is equal to the beginning of the second breath. A method according to any one of claims 1 to 12, equal to the initial flow value at time.

14. The method of claim 13, wherein the initial flow value at the beginning of the first breath and the initial flow value at the beginning of the second breath are the same.

15. Any of claims 4-7 or 12-14, wherein the first time corresponds to a maximum flow capacity value for a first breath and the second time corresponds to a maximum flow capacity value for a second breath. or the method described in paragraph 1.

comparing a final flow capacity value associated with the end of the first breath to an onset flow capacity value associated with the beginning of the first breath; and
determining, based at least in part on said comparison, whether the user is experiencing mouth leakage indicative of air leakage from the user's mouth during the first breath;
A method according to any one of claims 4 to 15, further comprising

17. The method of claim 16, wherein the starting flow capacity value is the minimum flow capacity value of the first breath.

18. The method of claim 16 or claim 17, wherein said last flow capacity value being greater than said starting flow capacity value indicates that the user is experiencing mouth leakage during the first breath.

excluding the first breath in determining an intentional leak characteristic curve of the respiratory therapy device in response to determining that the user is experiencing mouth leak during the first breath;
A method according to any one of claims 6 to 18, further comprising

20. The method of any one of claims 4-19, further comprising determining the amount of mouth leakage during the first breath.

A method of determining the amount of mouth leak during the first breath comprising:
finding a first time integral of a subset of the first breath flow-volume values ; and
subtracting the first time integral from the second time integral of a straight line between the maximum flow capacity value and the last flow capacity value of the first breath;
21. The method of claim 20, comprising:

22. The method of claim 21, wherein the subset of flow-volume values of the first breath are associated with an inspiratory portion of the first breath.

23. The method of claim 22, wherein onset of the exhale portion of the first breath is associated with a maximum flow capacity value of the first breath.

filtering the plurality of flow values includes (i) flow values affected by the user's breathing, (ii) flow values indicative of mouth leakage of the user, (iii) flow values associated with irregular breathing, or (iv) removing any combination thereof.

25. The method of any preceding claim, further comprising determining diffuser losses based at least in part on the determined intentional leak characteristic curve.

Based at least in part on the determined diffuser loss, (i) identifying a user interface associated with the respiratory therapy device, (ii) adjusting one or more settings associated with the user interface, (iii) 26. The method of claim 25, further comprising determining mouth leak associated with the user of the respiratory therapy device, or (iv) any combination thereof.

A method according to any preceding claim, wherein said subset of said plurality of flow values comprises 1% or less of said plurality of flow values .

a plurality of said subsets of flow values comprising: (i) 1, 2, 3, 4, or 5 flow values for the first breath and (ii) 1, 2 for the second breath , 3, 4 or 5 flow values.

A method for determining an intentional leak characteristic curve for a respiratory therapy device, comprising:
the computer
receiving flow data associated with a plurality of flow values of pressurized air directed to an airway of a user of the respiratory therapy device;
receiving pressure data associated with a plurality of pressure values of the pressurized air;
generating a first Cartesian coordinate having a first X value based on at least a first portion of the plurality of flow values and a first Y value based on at least a first portion of the plurality of pressure values;
a second X value based on at least the first portion of the plurality of flow values and a second portion corresponding in position within the respiratory cycle; and a second X value based on at least a second portion of the plurality of pressure values. generating a second Cartesian coordinate having a Y value of
determining an intentional leak characteristic curve of the respiratory therapy device based at least in part on the generated first Cartesian coordinates and the generated second Cartesian coordinates;
including
a first portion of the plurality of flow values corresponding to a first respiratory cycle, wherein the first X value of the first Cartesian coordinates is an average flow value of the first portion of the plurality of flow values ; a first portion of the plurality of pressure values corresponding to a first respiratory cycle, a first Y value of the first Cartesian coordinates comprising an average pressure value of the first portion of the plurality of pressure values;
Method.

30. The method of claim 29, wherein each of a plurality of said flow values has a corresponding timestamp.

30. or, further comprising, based at least in part on said generated flow data, identifying said first breathing cycle of the user comprising a first inhalation portion and a first exhalation portion. 31. The method of claim 30.

The method of any one of claims 29-31, wherein the intentional leak characteristic curve is determined using a polynomial.

33. The method of claim 32, wherein the polynomial is a quadratic equation with two non-zero constants.

The quadratic equation is
P ^~ = K ₁ Q ^{~ 2} + k ₂ Q ^~
P ^is the average pressure value of pressurized air in the airway for the first period;
Q ^is the average flow rate value of pressurized air in the airway during the first period;
k ₁ is the first non-zero constant,
_k2 is the second non-zero constant,
34. The method of claim 33, wherein

35. The method of claim 33 or claim 34, wherein the first Cartesian coordinate and the second Cartesian coordinate are used to solve two non-zero constants of the quadratic equation to determine an intentional leak characteristic curve. .

36. The method of any one of claims 32-35, wherein the polynomial defines the intentional leak of the respiratory therapy device by providing a flow rate corresponding to the intentional leak for a given pressure.

37. The method of claim 36, wherein the intentional leak is ventilatory flow of the respiratory therapy device.

Further, the method of any of claims 29-37 includes:
generating a third Cartesian coordinate having a third X value based on at least a third portion of the plurality of flow values and a third Y value based on at least a third portion of the plurality of pressure values;
An unintentional leak of the respiratory therapy device is determined based at least in part on the generated third Cartesian coordinate and the determined characteristic curve.
The method of any one of claims 29-37, further comprising

39. The method of claim 38, wherein the unintended leak indicates mask leak, mouth leak, or both.

40. The method of claim 38 or claim 39, wherein the third Y value exceeds a predetermined pressure threshold associated with a low probability of unintended leakage.

30. Neither of said first portion of said plurality of pressure values or said second portion of said plurality of pressure values exceeds a predetermined pressure threshold associated with a low likelihood of unintended leakage. 40. The method of any one of claims 1-40.

The predetermined pressure threshold is less than about 10 cm _H2O , less than about 9 cm H2O, less than about ₈ cm H2O, less than about 7 cm _H2O , less than about 6 cm _H2O , less than about ₅ cm H2O, _less than about 4 cm _H2O , about 42. The method of claim 40 or claim 41, which is less than 3 cm _H2O , or less than about ₂ cm H2O.

wherein said first portion of said plurality of flow values comprises at least a first flow value of said plurality of flow values, said first portion of said plurality of pressure values comprises at least a first of said plurality of pressure values; A method according to any one of claims 29 to 42, comprising one pressure value.

wherein the second portion of the plurality of flow values includes at least a second flow value of the plurality of flow values, and the second portion of the plurality of pressure values comprises at least a first of the plurality of pressure values. 44. The method of any one of claims 29-43, comprising two pressure values.

A method for determining an intentional leak characteristic curve for a respiratory therapy device, comprising:
the computer
receiving a plurality of flow values associated with pressurized air directed to an airway of a user of the respiratory therapy device, each of the plurality of flow values being the first be associated with the time of
receiving a plurality of pressure values associated with pressurized air directed into the user's airway, each of the plurality of pressure values corresponding to a respective one of a plurality of flow values;
determining an intentional leak characteristic curve of the respiratory therapy device using at least two of the subsets of the plurality of flow values and pressure values corresponding to at least two of the subsets of the plurality of flow values;
A method, including

A method of determining an intentional leak characteristic curve of the respiratory therapy device comprising:
At a first X value that is a first flow value corresponding to a first time associated with a first breath and a first pressure value corresponding to said first time associated with said first breath generating a first Cartesian coordinate with a first Y value;
at a second X value that is a second flow value corresponding to a first time associated with a second breath and a second pressure value corresponding to said first time associated with said second breath; generating a second Cartesian coordinate with a second Y value;
determining an intentional leak characteristic curve based, at least in part, on the first generated Cartesian coordinate and the second generated Cartesian coordinate;
46. The method of claim 45, comprising:

47. The method of claim 45 or claim 46, wherein the intentional leak characteristic curve is calculated using the following formula:
Z=P/Q= _k1Q + _k2
where Z is the intentional leak characteristic curve, P is the pressure value out of multiple pressure values, Q is the flow rate out of multiple flow values, _k1 is the first constant, _k2 is the second be a constant.

determining a plurality of corresponding flow capacity values for at least some of the plurality of flow rate values ;
48. The method of any one of claims 45-47, further comprising:

the first time associated with a first breath of the user and the first time associated with a second breath of the user by analyzing the determined plurality of corresponding flow capacity values; 49. The method of claim 48, identified based at least in part.

50. The method of claim 48 or claim 49, wherein said plurality of corresponding flow capacity values are determined by finding a time integral of at least a portion of said plurality of flow values.

51. The method of any one of claims 45-50, wherein each breath of the user includes an inhalation portion and an exhalation portion.

52. The method of claim 51, wherein the first time period is within the inhale portion of each breath.

53. The method of claim 51 or claim 52, wherein the first time is about the beginning of the inhale portion of each breath.

54. The method of any one of claims 47-53, wherein the first time period corresponds to a minimum flow capacity value in each breath.

52. The method of claim 51, wherein the first time period is within the exhale portion of each breath.

56. The method of claim 55, wherein the first time is about the beginning of the exhalation portion of each breath.

57. The method of any one of claims 45-56, wherein a first flow value corresponding to said first time is equal to an initial flow value at the beginning of each breath.

58. The method of claim 57, wherein the initial flow value at the beginning of the first breath and the initial flow value at the beginning of the second breath are the same.

59. The method of any one of claims 48-51 or 56-58, wherein the first time period corresponds to a maximum flow volume value in each breath.

comparing a final flow volume value associated with the end of a first breath to an onset flow volume value associated with the beginning of said first breath; and
determining, based at least in part on the comparison, whether the user is experiencing mouth leak during the first breath suggesting air is leaking from the user's mouth;
60. The method of any one of claims 48-59, further comprising

61. The method of claim 60, wherein the starting flow capacity value is the minimum flow capacity value of the first breath .

62. The method of claim 60 or claim 61, wherein an ending flow capacity value greater than the starting flow capacity value indicates that the user is experiencing mouth leakage during the first breath.

excluding the first breath in determining an intentional leak characteristic curve of the respiratory therapy device in response to determining that the user is experiencing mouth leak during the first breath;
63. The method of any one of claims 60-62, further comprising

64. The method of any one of claims 48-63, comprising determining the amount of mouth leakage during the first breath.

The method for determining the amount of mouth leak during the first breath comprises:
finding a first time integral of a subset of the first breath flow-volume values ;
subtracting the first time integral from a second time integral of a straight line between the maximum flow capacity value and the end flow capacity value of the first breath;
65. The method of claim 64, comprising:

66. The method of claim 65, wherein the subset of flow-volume values of the first breath are associated with an exhale portion of the first breath.

67. The method of claim 66, wherein an onset of the exhale portion of the first breath is associated with a maximum flow capacity value of the first breath.

filtering the plurality of flow values includes: (i) flow values affected by the user's breathing; (ii) flow values indicative of mouth leakage of the user; and (iii) flow values associated with irregular breathing. , or (iv) any combination thereof.

69. The method of any one of claims 45-68, further comprising determining diffuser losses based at least in part on the determined intentional leak characteristic curve.

Based, at least in part, on the determined diffuser loss: (i) identifying a user interface associated with the respiratory therapy device; (ii) adjusting one or more settings associated with the user interface; 70. The method of claim 69, further comprising (iii) determining a mouth leak associated with a user of a respiratory therapy device, or (iv) any combination thereof.

71. The method of any one of claims 45-70, wherein the subset of the plurality of flow values comprises 1% or less of the plurality of flow values .

The subset of the plurality of flow values includes (i) 1, 2, 3, 4, or 5 flow values for the first breath and (ii) 1, 2 for the second breath. 72. The method of any one of claims 45-71, wherein 1, 3, 4 or 5 flow values are included.

a control system including one or more processors, and a memory storing machine-readable instructions;
A system comprising
The control system is coupled to the memory, and the method of any one of claims 1-72, wherein the machine-readable instructions in the memory are executed by at least one of the one or more processors of the control system. enforced when executed by
system.

A system for determining an intentional leak characteristic curve of a respiratory therapy device, comprising a control system configured to implement the method of any one of claims 1-72.

A computer program product comprising instructions which, when executed by a computer, cause the computer to perform the method of any one of claims 1-72.

76. The computer program product of claim 75, wherein said computer program product is a non-transitory computer readable medium.