JP2017523877A - 治療的クッションシステム及び方法 - Google Patents
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Abstract
Description
[1001] 本出願は、2014年8月8日に出願された「治療的クッションシステム及び方法」という名称の米国特許出願第14/455,389号の優先権を主張するとともに、同出願の一部継続出願であり、2014年3月3日に出願された「治療的クッションシステム及び方法」という名称の米国特許出願第14/195,749号、2013年2月1日に出願された「治療的クッションシステム及び方法」という名称の米国特許出願第13/757,172号(現在、米国特許第8,661,586号)、2013年2月1日に出願された「治療的クッションシステム及び方法」という名称の米国特許出願第13/757,120号、2012年2月3日に出願された「治療的クッションシステム」という名称の米国特許仮出願第61/594,840号、2012年8月16日に出願された「治療的クッションシステム及び方法」という名称の米国特許仮出願第61/683,935号、並びに2012年10月8日に出願された「治療的クッションシステム及び方法」という名称の米国特許仮出願第61/710,913号に関連する。これら開示はそれぞれ、その内容全体を参照によって本明細書に組み込む。
[1282] 睡眠デバイス(SD:sleep device)を評価する無作為比較試験を実施した。Erik Person, MD, MS, et al.,“A Novel Sleep Assist Device Prevents Gastroesophageal Reflux:A Randomized Controlled Trial,”The American Journal of Gastroenterology,108:S1−S36, October 2013を参照のこと。研究で使用したSDは、本願の譲受人であるSan Diego,Californiaに所在のAmenity Health, Inc.によりMedcline(商標)の商標において販売されている、2部品の傾斜基部と抱き枕とからなるものであった。研究で使用したSDは、患者を、頭部及び胴部を上昇させる一方で側臥位に維持し、例えば、本明細書中に記載される治療的クッションシステム200と実質的に同じ又は類似のものである。頭部及び胴部を上昇させた状態で左側を下にして半固定姿勢で寝ると、横臥位胃食道逆流(GER)を大幅に減少させると仮定した。
[1287] 睡眠姿勢決めデバイス(SPD:sleep positioning device)を評価する第2研究も実施した。Sanath Allampati MD, et al.,“Use of a Sleep Positioning Device Significantly Improves Nocturnal Gastroesophageal Reflux Symptoms,”2014を参照のこと。SPDは、従来のベッドウェッジに比べて、2部品の傾斜基部(高さ9インチ)と側臥位用抱き枕とからなるものであった。この研究は、SPDを使用して眠った健常ボランティアにおいて、夜間GERD(酸曝露及び逆流症状発現)の減少を示した。同じく本願の譲受人によりMedcline(商標)の商標において販売されているこのSPDは、使用者を傾斜左側臥位(I−LLD)睡眠姿勢に配置し、維持する。この研究で使用したSPDは、例えば、本明細書中に記載される治療的クッションシステム200と実質的に同じ又は類似のものである。この研究の目的は、このSPDの使用によりGERDと診断された患者の夜間症状が減少するかどうかを決定すること、並びに夜間GERDの朝の影響の低減におけるその有効性を評価すること、及び夜間GERDに関する患者の懸念に対処することであった。
Claims (23)
- 支持要素部と、容器部と、を含む、基部支持体であって、前記支持要素部が、第1端部部分と、第2端部部分と、底面に対してある角度で配置された頂面と、を有し、前記支持要素部の前記第2端部部分が、前記支持要素部の前記第1端部部分の高さを超える高さを有する、基部支持体と、
前記容器部の少なくとも一部と、前記支持要素部の前記第2端部部分の少なくとも一部との間において、前記基部支持体に固定的に結合されている支持枕部材と、を備え、
前記支持枕部材と、前記支持要素部と、前記容器部とが、内部領域を集合的に規定し、前記内部領域が、使用者の腕の少なくとも一部を中に受容するように構成された受容部を含む、装置。 - 前記支持枕部材が前記容器部と一体形成されている、請求項1に記載の装置。
- 前記支持枕部材が第1発泡材料で形成されており、前記容器部が、前記第1発泡材料とは異なる第2発泡材料で形成されている、請求項1に記載の装置。
- 前記基部支持体が、前記内部領域と連通している解放空洞を規定し、前記解放空洞が開口部を含み、前記開口部が、前記基部支持体の側縁部に規定され、少なくとも部分的に前記基部支持体の前端部部分まで延びる、請求項1に記載の装置。
- 前記支持枕部材と前記容器部とが発泡材料で一体形成されている、請求項1に記載の装置。
- 前記容器部が前記支持要素部の前記第2端部部分から延びる、請求項1に記載の装置。
- 前記受容部が第1受容部であり、前記内部領域が、前記第1受容部と連通している第2受容部を含む、請求項1に記載の装置。
- 前記支持要素部又は前記容器部の少なくとも1つの頂面に配置されるように構成された本体要素をさらに含み、前記本体要素が側部支持ボルスタを含む、請求項1に記載の装置。
- 支持要素部と、容器部と、を含む、基部支持体であって、前記支持要素部が、第1端部部分と、第2端部部分と、底面に対してある角度で配置された頂面と、を有し、前記支持要素部の前記第2端部部分が、前記支持要素部の前記第1端部部分の高さを超える高さを有する、基部支持体と、
前記容器部に結合されている、発泡材料によって形成された支持枕部材であって、前記支持枕部材と、前記支持要素部と、前記容器部とが、使用者の腕の少なくとも一部を中に受容するように構成された受容部を含む内部領域を集合的に規定する、支持枕部材と、
を備える、装置。 - 前記支持枕部材が第1発泡材料で形成されており、前記容器部が、前記第1発泡材料とは異なる第2発泡材料で形成されている、請求項9に記載の装置。
- 前記支持枕部材が、前記容器部の頂面と実質的に面一の頂面を有する、請求項9に記載の装置。
- 前記容器部が前記支持要素部の前記第2端部部分から延びる、請求項9に記載の装置。
- 前記支持枕部材が、使用者に肩解放部を提供するように構成された切抜部分を規定する、請求項9に記載の装置。
- 前記基部支持体が、前記内部領域と連通している解放空洞を規定し、前記解放空洞が開口部を含み、前記開口部が、前記基部支持体の側縁部に規定され、少なくとも部分的に前記基部支持体の前端部部分まで延びる、請求項9に記載の装置。
- 少なくとも前記支持要素部の頂面に配置されるように構成された本体要素をさらに備え、前記本体要素が側部支持ボルスタを含む、請求項9に記載の装置。
- 前記本体要素が頚部支持部を含む、請求項15に記載の装置。
- 外カバー内に配置された発泡挿入部材を含む本体要素を含み、
前記本体要素が、円弧部と、前記円弧部からそれぞれ延びる第1アームと、第2アームと、を備え、
前記本体要素が側部支持ボルスタを含み、前記側部支持ボルスタが、前記第1アーム又は前記第2アームの少なくとも1つに配置されており、使用者を側位に維持するように構成されている、装置。 - 前記側部支持ボルスタが、角度を成した頂面を含む、請求項17に記載の装置。
- 前記本体要素が、前記第1アーム上に配置された第1側部支持ボルスタと、前記第2アーム上に配置された第2側部支持ボルスタと、を含む、請求項17に記載の装置。
- 前記本体要素が、前記円弧部上に配置された頚部支持部をさらに含み、前記頚部支持部は、使用者の頭部が前記円弧部上に配置されているときに、前記使用者の頚部を支持するように構成されている、請求項17に記載の装置。
- 前記頚部支持部が円弧形状である、請求項20に記載の装置。
- 前記頚部支持部が前記本体要素の幅にわたって延びる、請求項20に記載の装置。
- 前記外カバーが、第1材料で形成された上部部分と、前記第1材料とは異なる第2材料で形成された下層部と、を含む、請求項17に記載の装置。
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JP2020109126A JP6978550B2 (ja) | 2014-08-08 | 2020-06-24 | 治療的クッションシステム及び方法 |
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US14/455,389 | 2014-08-08 | ||
US14/455,389 US9427366B2 (en) | 2014-08-08 | 2014-08-08 | Therapeutic cushion systems and methods |
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EP3177183A4 (en) | 2018-03-21 |
US9427366B2 (en) | 2016-08-30 |
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