JP7178952B2 - 患者インターフェース用のクッション - Google Patents
患者インターフェース用のクッション Download PDFInfo
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- JP7178952B2 JP7178952B2 JP2019080949A JP2019080949A JP7178952B2 JP 7178952 B2 JP7178952 B2 JP 7178952B2 JP 2019080949 A JP2019080949 A JP 2019080949A JP 2019080949 A JP2019080949 A JP 2019080949A JP 7178952 B2 JP7178952 B2 JP 7178952B2
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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
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
- A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
-
- 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
-
- 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
- A61M16/06—Respiratory or anaesthetic masks
-
- 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
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
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- A—HUMAN NECESSITIES
- A62—LIFE-SAVING; FIRE-FIGHTING
- A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
- A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
- A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
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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
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
Description
本願は、2005年1月12日に出願された米国仮出願第60/643,130号および2005年10月7日に出願された第60/724,303号のの利益を主張し、各出願の全体を参照によりここに援用する。
ただし、顔面接触部分14は、例えば全般に台形など、他の適切な形状を有してもよい。
図示されている実施形態では図15に最も良く示されているように、クッション10は、患者の鼻梁に沿って密封を行う鼻梁領域16と、患者の鼻、頬、および口に沿って密封を行う一対の頬領域15と、患者の顎に沿って密封を行う顎領域20とを含む。一対の頬領域15はさらに、患者の鼻の両側に沿って密封を行う一対の鼻側部領域17と、患者の上側頬に沿って密封を行う一対の上側頬領域18と、患者の下側頬および患者の口の両側に沿って密封を行う一対の下側頬領域19として画定することができる。
例えば、クッション10、210、310、410の各開口22の下側部分は、ほぼ同じ幅を有する。
図9および10~14に最も良く示されているように、クッション10の顔面接触部分14は、土台壁28と、土台壁28の下に位置し、そこから延びる一対の基礎支持クッション30と、膜32とを備える。膜32は、下のクッション30の少なくとも一部分をほぼ覆い、顔面接触部分14に密封構造をもたらすために設けらる。土台壁28および基礎クッション30は、膜32に対する支持構造を形成する。
本発明の他の態様は、クッション10の土台壁28、基礎クッション30、および膜32のサイズおよび構造に関する。図48~50は、UltraMirage(登録商標)クッション700の土台壁728、基礎クッション730、および膜732を示している。図示されているように、クッション10は、UltraMirage(登録商標)クッション700と異なる断面形を有する。
図示されているように、基礎クッション30は、基礎クッション30が土台壁28に対して動くことができるような、土台壁28とのばね状の連結部を有する。つまり、基礎クッション30は、空間34内へ移動可能である(基礎クッション30もまた、空間33内へ移動可能である)。したがって、フレームの力が加えられるとき、ばねの力がもたらされ、フレーム力が解放されるとき、基礎クッション30はその最初の位置まで弾性的に戻る。基礎クッション30および/または土台壁28は、任意の適切なばね定数を有してよい。このばね定数は、例えば土台壁28の厚さにテーパを付ける及び/または厚さを変化させ、基礎クッション30の中間部分および/または下側部分の厚さを変化させることによって、その長さに沿った任意の場所で、異なった値をとることができる。また、ばね状の連結部を基礎クッション30全体に沿って延在してもよく、あるいは、ばね状の連結部を頬骨領域などの一定の領域に集中させてもよい。
図30A~30Nに、土台壁28および基礎クッション30の代替実施形態が示されている。これらの実施形態はそれぞれ、使用中に、基礎クッション30の可撓性をもたらす配置を提供する。図30Aでは、基礎クッション30は、閉鎖された空間60を画定する。この空間60は任意選択で、加圧空気、発泡体(foam)、ゲル、またはエラストマー材料で充填し、使用中に基礎クッション30の動きを減衰させるように適合させることができる。図30Bでは、基礎クッション30の下にある空間34は、呼吸空洞の内部にある。また、基礎クッション30は、呼吸空洞の内部から土台壁28の方へ湾曲した弓状の形状を有する。ただし、基礎クッション30は、他の任意の適切な形状を有してもよい。例えば、図30Cの基礎クッション30は、球根状の形状(bulbous shape)を有する。この形状は中空でも中空でなくてもよい。図30Dでは、基礎クッション30は、全般にZ形の形状を有する。図30Eおよび30Fでは、基礎クッション30は球根状の形状を有し(中空でも中空でなくてもよい)、基礎クッション30の下にある空間34は傾斜した構造を有する。図30C、30E、および30Fでは、球根状の形状は任意に、加圧空気、発泡体、ゲル、またはエラストマー材料で充填し、使用中に基礎クッション30の動き減衰させるように適合させてもよい。図30Eでは、空間34の傾斜した構造は、使用中に基礎クッション30を土台壁28の方に下向きに向けるように適合され、図30Fでは、空間34の傾斜した構造は、使用中に基礎クッション30を呼吸空洞の方に内向きに向けるように適合される。図30G、30H、および30Iでは、基礎クッション30は、全般にT字形の形状を有する。また、図30Hおよび30Iでは、土台壁28は、T字形の基礎クッション30の下に閉鎖された空間62を画定する。閉鎖された空間62は任意に、加圧空気、発泡体、ゲル、またはエラストマー材料で充填し、使用中に基礎クッション30の動きを減衰させるように適合させてもよい。さらに、閉鎖された空間62内部の圧力を変化させることによって、ばね定数を変化させることができる。
さらに、(図30Hに示すように)空間62の下側表面は、使用中に基礎クッション30を呼吸空洞の方に内向きに向けるように適合された傾斜構造を有してもよい。図30Aの閉鎖された空間60の下側表面もまた、使用中に基礎クッション30を方向付けるための傾斜構造を有することができる。図30Jおよび30Kでは、基礎クッション30は、ばね特性を弱めるために細長い断面長さを有する。図30Lには、基礎クッション30を備え、膜のない一重壁構造が示されている。図30Mでは、基礎クッション30の下にある空間34が非常に大きくなっている。図30Nでは、ばね構造が土台壁28の下に設けられている。
空間34により、基礎クッション30は、UltraMirage(登録商標)クッション700と比較した場合、所定の大きさの力に対して大きく移動することができる。つまり、基礎クッション30は、所与の力に対してより大きく動くことができる。例えば、図31は、クッション10とUltraMirage(登録商標)クッション700の、力と移動量の全般的な関係を示している。図示されているように、クッション10のカーブは、UltraMirage(登録商標)クッション700の指数関数タイプのカーブよりも平坦である。したがって、基礎クッション30は、UltraMirage(登録商標)クッション700と比較した場合、剛性が小さく、柔軟性がある。空間34によってもたらされるばね特性を変化させるために、ゲル、シリコーンまたは他の構造体で空間34を充填してもよいことに留意されたい。
したがって、図31に示されているクッションは、図32に示されているクッションよりも、所与の力に対して大きく移動することができる。また、図32にあるクッション10のカーブは、移動量が小さいときはクッション10の力のほうが大きくなって密封が確保され、移動量が大きくなるとクッション10の力のほうが小さくなって、より長い範囲の移動量に対して快適性が維持されるように、UltraMirage(登録商標)クッション700のカーブと交差する。
図34Aおよび34Bは、クッション10の選択された領域において典型的な従来技術のクッション、例えばUltraMirage(登録商標)クッション700と比較した場合弱いばね特性をもたらすために用いられる、可撓性を有する基礎クッション30の、延在された長さを示されている。この長さa-bは変形させることができ、したがって、この長さによってばね特性がもたらされる。図示されているように、クッション10の長さa-b(図34A)は、UltraMirage(登録商標)クッション700(図34B)と比較した場合、基礎クッション30の曲率のために、かなり長くなる。図示されている実施形態では、クッション10の長さa-bは22.84である。ただし、一実施形態では、クッション10の長さa-bは、16~30の範囲、好ましくは20~25の範囲、最も好ましくは22~24の範囲にすることができる。他の実施形態では、クッション10の長さa-bは、16~20の範囲にすることができる。長さb-cはかなり硬く、変形してばね特性をもたらすことはない。クッション10において追加された長さは、基礎クッション30の形状を弓状にすることによって達成され、この形状にした結果、空間34が生じる。この追加された長さによって可撓性が加わり、クッション10に対する可動範囲が大きくなる。図30Jおよび30Kに、部分長さをさらに長くするための、他の実施形態が示されている。
膜32は、患者の鼻梁、鼻の側部、上側頬、下側頬、顎の各領域16、17、18、19、20の周りに効果的な密封を形成するように構成される。本発明の他の態様は、クッション10の鼻梁領域16における膜32の構造に関し、この領域の密封および快適性を改善するように構成されている。
図10に示すように、鼻梁領域16の膜32は、UltraMirage(登録商標)クッション700(図48)の対応する部分よりも鋭角的な断面外形を有する。具体的には、膜32は、その内側縁部で終端するように、半径に沿ってクッションの空洞の方に内向きに湾曲する大きい輪郭の部分を備えている。この構成は、患者の鼻梁領域の輪郭又は曲率に、より密接して従う。図示されている実施形態では、膜32は、クッションの顔面接触平面に対して、例えば30~50°の範囲の角度が付いている。対照的に、UltraMirage(登録商標)クッション700の対応する角度は、約6°である。この構成によって、患者に、より良好な快適性および嵌め合いがもたらされる。
図38に最も良く示されているように、鼻梁領域16は、正面から見て、例えば平坦な鼻梁から鋭角的な鼻梁まで多様な患者に対するより快適な嵌め合いをもたらすように変形できる、例えば膜の湾曲部の頂部にほぼ平坦な部分50を有する。
患者の鼻梁に対して膜36の表面領域をほぼ平坦に保つことは、膜の縁部での漏れを防止する。
ResMedTM Activa(登録商標) Nasal Cushion(ResMedTM Activa鼻クッション)-16mm
Respironics Comfort Full Face Cushion(Respironics快適フルフェースクッション)-26mm
ResMed Bubble Nasal Mask Cushion(ResMed気泡鼻マスククッション)-43mm
Healthdyne Soft Series Nasal Mask Cushion(Healthdyneソフトシリーズ鼻マスククッション)-17mm
図39~40Bに示すように、膜32の内側縁部は、患者の鼻および口を受容する開口22を画定する。図示されているように、開口22は、全般に三角形の形状を有する。また、開口22の頂部は、例えば鍵穴などの丸みを帯びた切欠き42を有する。切欠き42により、特に鋭角的な鼻を有する患者など、様々なサイズおよび形状の鼻梁領域による密封が改善される。切欠き42は、1.5~6.0mmの範囲、好ましくは約3.0mmの曲率半径を有する。この丸みを帯びた鍵穴の形状は、図40Aに示すように、例えば鍵穴の形状がクッションの内側部分から外側へ延在している、少なくとも3.0mmの長さを有する。
図41~45には、患者の鼻と係合した膜32の鼻梁領域16のロール作用を示すために、クッション10の鼻梁領域16の外側表面に用いた手書きの線(hand-marked lines)が含まれている。上記のように、鼻梁領域16の膜32は、図41に示されているように、細長い頂部38を形成するように合流する傾斜した側部36を含んでいる。患者の鼻梁(小さい棒線で模擬的に示されている)が膜32の鼻梁領域16と係合され(図42参照)、この膜32が急な勾配で反転する部分44を作り出し、そこで、膜32が鼻側部領域17に設けられた基礎クッション30の間を移動すると、傾斜した側部36がその位置で反転する。膜32がさらに患者の鼻梁と接触すると、図43に示すように膜32が患者の顔面と一致するので、反転した断面の前縁部46がクッション10の上端のほうに「ロール」する。この構造は、クッション10が、鼻根の高さ(rootdepth at the nose)が比較的低い患者や比較的高い患者を含む、多様な鼻の輪郭を有する患者に対応可能になるので有利である。図44および45は、完全に反転した位置にある膜32の鼻梁領域16を示している。患者の鼻と係合したときに急な勾配で反転する部分44が生じることによって、より良好な密封をもたらされ、折り目および/または折重ね及びそれらに伴う不快感および漏れの恐れを軽減される。つまり、この構造により、患者快適性および密封に有害になり得る折り目の代わりに、ロール作用が促進される。
図54~71は、クッション510の他の実施形態を示している。各図では、クッション10とほぼ同様のクッション510の部分は、同様の参照番号で示される。
上記のように、基礎クッション830は、クッション810の横側のみに設けられるのが好ましい。
これは、領域R1よりも可撓性のあるばね成分のための比較的小さいオフセットを設けている。
12 非顔面接触部分
14 顔面接触部分
15 頬領域
16 鼻梁領域
17 鼻側部領域
18 上側頬領域
19 下側頬領域
20 顎領域
22 開口
28 土台壁
29 フレーム連結部
30 基礎クッション
32 膜
34 空間
35 細長い稜部
36 傾斜した側部
38 細長い頂部
39 クッションの最も外部の点
42 切欠き
44 急な勾配で反転する部分
46 前縁部
60 空間
62 空間
210 特別小さいクッション
310 小さいクッション
410 大きいクッション
510 クッション
512 顔面非接触部分
516 鼻梁領域
528 土台壁
529 フレーム連結部
530 基礎クッション
532 膜
534 空間
535 細長い稜部
536 傾斜した側部
538 頂部
540 前方端部
550 平坦部分
610 クッション
628 土台壁
632 膜
700 市販のクッション
722 開口
728 土台壁
729 フレーム連結部
730 基礎クッション
731 縦に延びる溝
732 膜
739 クッションの最も外部の点
810 クッション
828 土台壁
830 基礎クッション
832 膜
880 外部表面
882 外部表面
884 外部表面
910 クッション
928 土台壁
930 基礎クッション
932 膜
940 基準寸法
950 基準寸法
990 テーパ形の部分
Claims (15)
- 呼吸に適した気体を患者に送達する患者インターフェース用クッションであって、前記クッションは、鼻梁領域、一対の鼻側部領域、一対の上側頬領域、一対の下側頬領域、及び、顎領域を含み、前記クッションは、
フレームに連結されるように構成された土台壁を含む顔面非接触部分と、
前記患者の顔面に係合するように構成された顔面接触部分と、
を備え、
前記顔面接触部分は、前記患者の顔面の鼻梁領域、一対の頬領域、及び、顎領域上にそれぞれ連続的な密封を形成するように適合された、鼻梁領域、一対の頬領域、及び、顎領域を含む膜を備え、
前記膜は、前記クッションの最も幅が広い点を形成し、前記土台壁の下部分は、前記最も幅が広い点に対して完全に内側にオフセットされており、
前記膜は、前記患者の鼻を受容するように適合された開口を画定する内側縁を有し、かつ、
前記顔面接触部分を上向きにした状態で前記クッションがある際、
1)前記クッションの前記鼻梁領域の前記膜は、前記クッションを左右に分割する中心線に沿った細長い頂部で合わさる2つの側部を含む外部表面を有し、前記外部表面のそれぞれの側部が前記中心線から下側に傾斜している、
2)前記中心線に沿った断面図において、前記クッションの前記鼻梁領域の前記膜の前記外部表面は、a)前記鼻梁領域の前記膜の頂部から前記膜の前記内側縁に前記中心線に沿って下方に湾曲し、かつ、b)前記膜の前記頂部から前記膜の前記内側縁から離れる方向に前記中心線に沿って下方に湾曲し、これにより、凸形状を形成し、
3)前記中心線に沿った断面図において、前記クッションの前記顎領域の前記膜は、凸形状を形成する外部表面を有し、これにより、前記外部表面が前記顎領域の前記膜の頂部から前記膜の前記内側縁に下方に湾曲し、
4)前記クッションの前記顎領域の前記膜の前記外部表面は、前記鼻梁領域の反対側において前記下側頬領域の一方から前記下側頬領域の他方まで延在し、前記患者の顎領域と係合するように適合された凸形状を形成する、
ことを特徴とするクッション。 - 前記膜の前記一対の頬領域は、一対の鼻側部領域、一対の上側頬領域、及び、一対の下側頬領域を含むことを特徴とする請求項1に記載のクッション。
- 前記鼻梁領域の前記膜は、患者の鼻梁領域と係合するために、使用において、前記凸形状の一部が反転するように構成されることを特徴とする請求項1または2に記載のクッション。
- 前記クッションの前記鼻梁領域の前記膜の前記2つの側部は、前記患者の鼻梁領域と係合するために、使用において、反転するように構成されることを特徴とする請求項3に記載のクッション。
- 前記クッションの前記鼻梁領域の前記膜の前記頂部は、1.0mm~5.0mmの曲率半径を形成することを特徴とする請求項1~4のいずれか一項に記載のクッション。
- 前記クッションの前記鼻梁領域の前記膜の前記2つの側部それぞれは、前記鼻梁領域の頂部中心線に対して30°~60°の接線角度を有することを特徴とする請求項5に記載のクッション。
- 前記クッションの前記鼻梁領域は、様々な顔面形状に適合するように比較的高い柔軟性を有し、前記クッションの前記鼻梁領域の側部は、前記患者の顔面との前記膜の安定した接触を容易にするために、前記クッションに横向きの安定性をもたらすように比較的剛性であることを特徴とする請求項1~6のいずれか一項に記載のクッション。
- 前記クッションの前記上側頬領域は、前記クッションの前記鼻梁領域の前記側部より剛性が低く、前記クッションの前記下側頬領域は、前記クッションの前記上側頬領域より剛性が低いことを特徴とする請求項7に記載のクッション。
- 前記クッションの前記顎領域は、前記クッションの前記下側頬領域に対して比較的柔軟であることを特徴とする請求項8に記載のクッション。
- 使用において、前記クッションは、前記一対の下側頬領域より前記鼻梁領域の前記一対の側部においてより高い横方向の剛性を有することを特徴とする請求項9に記載のクッション。
- 前記膜を支持する基礎クッションをさらに備え、前記基礎クッションは、少なくとも一対の上側頬領域、一対の下側頬領域、及び、鼻領域の一対の側部を含み、
前記膜は、少なくとも部分的に、前記基礎クッションを覆い、これにより、使用において、前記膜は、前記基礎クッションと前記患者の顔面との間に位置することを特徴とする請求項1~10のいずれか一項に記載のクッション。 - 前記基礎クッションと前記膜とは、前記クッションの少なくとも前記上側頬領域及び前記下側頬領域において二重壁構造を形成し、これにより、前記基礎クッションは、前記クッションが着用される際、前記膜の移動を抑えるように位置することを特徴とする請求項11に記載のクッション。
- 前記クッションは、前記クッションの前記顎領域の大部分における前記膜によって形成される単一壁構造を有し、これにより、前記クッションが着用される際、前記顎領域の前記膜が、前記クッションの呼吸空洞の方に内向きに容易に曲がることを可能にすることを特徴とする請求項12に記載のクッション。
- 前記基礎クッションは、ばね定数を規定する前記土台壁とのばね状の連結部を有することを特徴とする請求項11~13のいずれか一項に記載のクッション。
- 前記クッションの前記土台壁と前記鼻梁領域の前記一対の側部の前記基礎クッションとの第1の断面構造が、前記クッションの前記土台壁と前記下側頬領域の前記基礎クッションとの第2の断面構造と異なるばね定数を有することを特徴とする請求項14に記載のクッション。
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