JP4758413B2 - 被験者の気道に加圧気体を供給する供給装置 - Google Patents
被験者の気道に加圧気体を供給する供給装置 Download PDFInfo
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/20—Valves specially adapted to medical respiratory devices
- A61M16/201—Controlled valves
- A61M16/202—Controlled valves electrically actuated
- A61M16/203—Proportional
- A61M16/205—Proportional used for exhalation control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
- A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
- A61M16/022—Control means therefor
- A61M16/024—Control means therefor including calculation means, e.g. using a processor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/20—Valves specially adapted to medical respiratory devices
- A61M16/201—Controlled valves
- A61M16/202—Controlled valves electrically actuated
- A61M16/203—Proportional
- A61M16/204—Proportional used for inhalation control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
- A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
- A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
- A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
- A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
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- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Description
本発明は、呼吸及び/又は心臓疾患を治療する方法と装置、特に、閉塞性睡眠無呼吸症候群、慢性閉塞性肺疾患、鬱血性心不全及び他の呼吸器疾患及び/又は呼吸疾患を治療するため、呼吸サイクルの少なくとも一部間で被験者(患者)の気道に呼吸気体の圧力を供給する方法と装置に関する。
閉塞性睡眠無呼吸症候群(OSAS)の間、被験者が眠る間に気道は狭窄状態及び/又は虚脱状態(圧潰状態)となる傾向がある。連続的気道正圧(連続的気道正圧(CPAP))療法は、気道を強制的に開放する圧力を供給して狭窄状態を回避する副木的機能がある。連続的気道正圧(CPAP)では、気道開放圧力は、睡眠研究の間、気道の狭窄を防止するのに十分な大きさに最適化され一定に保持される。一定の強制気道開放圧力、即ち連続的気道正圧(Continuous Positive Airway Pressure-CPAP)を与えることは、圧潰気道により提起される問題の単純な解決法である。しかしながら、この解決法は、大部分の呼吸サイクルに対して気道の開放を支持するのに必要な圧力より高い圧力を被験者に供給しなければならない。
Pdelivered = Pbase+ 利得 * 流れ
但し、「Pdelivered」は、被験者の界面材に供給される圧力、「Pbase」は、基礎ライン圧力(ゼロより大きいかゼロに等しく、概念的に呼気状態気道圧力(EPAP)に等しい)、「流れ」は、流れ変換器により決定される被験者の概算流量、「利得」は流量に基づき圧力の増加に用いる定数である。利得定数は、吸気作用(正の流れ)に対して1つの定数が精密に決定され、呼気作用(負の流れ)に対して異なる定数が精密に決定される。
及び
Pexhalation = Pbase+ GainExp * 流れ
但し、「GainInsp」は、流量に基づいて圧力を上昇するために吸気作用(正の流れ)の間に使用される定数、「GainExp」は流量に基づいて圧力を減少するために呼気作用(負の流れ)の間に使用される定数である。
Pbase + GainInsp*流れ
又は
Pbase + Pprofile
但し、「Pinhalation」は吸気作用の間に被験者の界面材に供給される圧力、「Pbase」は、基礎ライン圧力(概念的に呼気状態気道圧力(EPAP)に等しい)、「流れ」は、見積もられた被験者に対する気体流、「GainInsp」は、流量に基づいて圧力を増加するために吸気作用(正流れ)の間に使用する定数、「Pprofile」は、吸気作用の開始時に気道を支えるために圧力変動を発生する関数である。この種の圧力変動機能は、タイムベース(例えば図6Bの点線60で示す後方傾斜変化)の例えば図6Bの点線58で示す段階変化又は他の機能的形状のように連続的でよい。
及び
Pinhalation = Pbase+ GainInsp * 流れ Xから呼気開始まで
但し、「Pinhalation」は、吸気作用の間に被験者の界面材に供給される圧力、「Pbase」は、基礎ライン圧力(概念的に呼気状態気道圧力(EPAP)に等しい)、「流れ」は、見積もられた被験者の気体流、「GainInsp」は、流量に基づいて圧力を増加するために吸気作用(正流れ)の間に使用される定数、「Pprofile」は吸気作用の開始時に気道を支える圧力変動を生成するいかなる関数である。この種の関数は、例えば後方に傾斜する変化のような段階変化又はタイムベースのように連続的な形状又は他の機能的形状でよい。「X」は、時間又は曲率、ピーク流量からの低下百分率、積分、導関数、従来の呼吸分析又は流量分析と時間との組合せのように流れ信号の解析により決定される予め選択された転移点である。
Pinhalation = CPAP(連続的気道正圧)
及び
Pexhalation = CPAP(連続的気道正圧)+ GainExp *流れ
但し、「GainExp」は、流量に基づいて圧力を減少するために呼気(負流れ)の間に使用される定数である。
Pinhalation = IPAP(気道吸気正圧)
及び
Pexhalation = EPAP(呼気状態気道圧力)+ GainExp * 流れ
但し、「GainExp」は、流量に基づいて圧力を減少するために呼気(負流れ)の間に使用される定数である。
Pinhalation(t0〜tl)=IPAP(気道吸気正圧)
Pinhalation(tl〜t2)= Pbase + AutoGainInsp* 流れ
及び
Pexhalation = Pbase + GainExp * 流れ
但し、「流れ」は、推定された流量、「t0」は、呼吸開始時点、「t1」は、推定された流量が吸気ピーク流量の所定の百分率であるときの時点、「t2」は、呼気開始時点、「IPAP」は、連続的に印加される気道吸気正圧、「Pinhalation(t0〜tl)」は、時点t0からt1まで被験者に供給される圧力、「Pbase」は、連続的基礎圧力、「AutoGainInsp」は、時点t1での(IPAP-Pbase)/流れに等しい、「Pinhalation(tl〜t2)」は、時点t1からt2まで被験者に供給される圧力、「GainExp」は、被験者に供給される圧力を減少するために呼気の間に使用される定数、「Pexhalation」は、呼気の間に被験者に供給される圧力である。
°吸気流の減少;
°吸気容積の減少;
°流れ又は圧力信号分析により定まる気道抵抗の増加;
°圧力又は音の変化により示される気道不安定性;
°動脈中の酸素飽和度の低下;又は
°気道直径の減少
また、現在のシステムでは、基礎圧力(Pbase)を調整して、気道(呼吸停止)の完全な崩壊又は危険な圧潰(危険な呼吸低下)を防止することができる。流れ信号の分析及び/又は反射圧力波又は圧力及び流量の組合せにより呼吸停止を検出して、気道開通を決定することができる。更に、気道圧潰又は呼吸運動の欠陥の何れによって呼吸停止が発生したのかを決定することが重要な場合もある。妨害事由を検出した場合、基礎圧力を増加して、気道を開くことができる。本発明のシステムの別の性能は、前記の条件が存在しない場合に、最小のPbaseを維持することである。
°吸気流の減少;
°吸息性の容積の減少;
°流量信号分析又は圧力信号分析により決定される気道抵抗の増加;
°圧力変化又は音変化により示される気道不安定性;
°動脈中の酸素飽和度の低下;
°気道直径の減少。
Pinhalation = CPAP(連続的気道正圧)
Pexhalation = CPAP(連続的気道正圧)−(所定の圧力変動)。
Pexhalation = 下記のより大きい方:
Pbase -(GainExp *流れ)
又は
現在の圧力、
但し、「現在の圧力」は、呼気段階の間のその時点で被験者に供給される圧力である。
Pexhalation = Pbase −(Volumeto be exhaled * GainExp)
但し、「Pbase」は、基礎ライン圧力(ゼロ以上で概念的に呼気状態気道圧力(EPAP)に等しい)、「Volumeto be exhaled」は、被験者内の現在の気体容積から安静状態の被験者の気体容積を引いた差、「GainExp」は圧力の減少のために呼気(負流れ)の間に使用される定数である。
呼気段階の開始(t0)からXまで:
Pexhalation = Pbase-(Volumeto be exhaled * GainExp)
但し、「t」は、呼気段階の開始に続く現在の時間、「X」は、時間又は例えば曲率、ピーク流量からの降下百分率、積分値、導関数、事前の呼吸分析若しくは流れ分析と時間との組合せ等の流れ信号の分析により決定される呼気段階の開始後に予め定められた転移点である。
Claims (5)
- (a)送風機と、
(b)該送風機により発生する気体流を被験者の気道に供給する1つの配給導管であって、前記送風機に作動接続された基端部、及び、被験者の気道に作動接続された先端部を含む配給導管と、
(c)前記配給導管の先端部に作動接続され、前記配給導管から周囲大気へと気体流を導く、連続的に開放される排出システムと、
(d)前記配給導管の基端部に作動接続された、前記配給導管内の気体又は気体流に関する特性を監視するセンサと、
(e)前記送風機、前記配給導管、又は、前記送風機及び前記配給導管に取り付けられて、前記配給導管内の気体の圧力を制御する圧力コントローラと、
(f)(1)気体流発生装置の動作特性から独立してかつ呼気段階の開始前に、前記被験者に供給すべきかつある期間にわたり変化する気体流の減少される圧力変動を決定し、(2)(a)呼吸周期の吸気段階の少なくとも一部の間に第1の圧力レベルで被験者に気体流を供給すると共に、(b)呼吸周期の呼気段階の少なくとも一部の間に減少された圧力変動で被験者に気体流を供給するように、圧力コントローラを制御する制御手段とを備えることを特徴とする被験者の気道に加圧気体を供給する供給装置。 - 前記減少される圧力変動の大きさ、持続時間、又は、大きさ及び持続時間の両方を設定する入力装置を備える請求項1に記載の供給装置。
- 前記減少される圧力変動は、呼気の初期に急激に低下しかつ前記第1の圧力レベルに向かって徐々に上昇する請求項1に記載の供給装置。
- 前記第1の圧力レベルは、連続的気道正圧に対応する請求項1に記載の供給装置。
- 呼吸周期の呼気段階の全期間中に前記減少された圧力変動を被験者に供給する請求項1に記載の供給装置。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US09/041,195 | 1998-03-12 | ||
US09/041,195 US6105575A (en) | 1994-06-03 | 1998-03-12 | Method and apparatus for providing positive airway pressure to a patient |
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JP2000535400A Division JP4081239B2 (ja) | 1998-03-12 | 1999-03-11 | 被験者の気道へ正圧を供給する装置 |
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JP2008110221A JP2008110221A (ja) | 2008-05-15 |
JP4758413B2 true JP4758413B2 (ja) | 2011-08-31 |
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JP2000535400A Expired - Lifetime JP4081239B2 (ja) | 1998-03-12 | 1999-03-11 | 被験者の気道へ正圧を供給する装置 |
JP2007320098A Expired - Lifetime JP4758413B2 (ja) | 1998-03-12 | 2007-12-11 | 被験者の気道に加圧気体を供給する供給装置 |
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US (2) | US6105575A (ja) |
EP (2) | EP1061981B1 (ja) |
JP (2) | JP4081239B2 (ja) |
AU (1) | AU3080199A (ja) |
CA (1) | CA2323455A1 (ja) |
DE (1) | DE69942719D1 (ja) |
WO (1) | WO1999045989A1 (ja) |
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US6105575A (en) | 2000-08-22 |
EP1061981A4 (en) | 2002-10-23 |
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EP1061981A1 (en) | 2000-12-27 |
EP2184080A1 (en) | 2010-05-12 |
CA2323455A1 (en) | 1999-09-16 |
US6609517B1 (en) | 2003-08-26 |
JP4081239B2 (ja) | 2008-04-23 |
EP1061981B1 (en) | 2010-09-01 |
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