JP2018504973A - 経腸供給デバイス - Google Patents
経腸供給デバイス Download PDFInfo
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- JP2018504973A JP2018504973A JP2017540756A JP2017540756A JP2018504973A JP 2018504973 A JP2018504973 A JP 2018504973A JP 2017540756 A JP2017540756 A JP 2017540756A JP 2017540756 A JP2017540756 A JP 2017540756A JP 2018504973 A JP2018504973 A JP 2018504973A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0015—Gastrostomy feeding-tubes
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Abstract
Description
i)経腸流体のリザーバを提供し、経腸流体と適合性のある壁材料を備える、可撓性本体部分と、ここで、可撓性本体部分はそこに配設されている、
ii)供給チューブに接続可能な出口と
を備える、分注装置を提供する。
高濃度魚油を用いた適合性試験
4つの異なるアンプル材料に、トリグリセリド形態のオメガ-3脂肪酸EPA及びDHAを含む濃縮魚油(PronovaPure 400:200 TG)を充填し、40℃/相対湿度75%に置いた。アンプルの材料は、次の通りであった。
1.ポリプロピレン
2.低密度ポリプロピレン
3.高密度ポリプロピレン
4.共押出-多層積層体
5.ガラス(参照として)
オメガ-3脂肪酸で充填されたチューブ分注装置
本発明によるチューブ分注装置を調製し、経腸で対象に送達するための脂肪酸混合物を充填する。チューブのスリーブは、ポリエチレン層の間に中間アルミニウム層を備える、約300μmの総厚を有する多層壁材料を備える。チューブの頭部、すなわち、底部及び出口は、自動頭部形成機を用いて、継ぎ目のないスリーブに嵌合される。出口は、密閉手段を備える、図9bに示されるようなメス型ENFitコネクタ部を有して設計されている。チューブは、出口の反対側の頂部から経腸流体で充填され、圧着されて密閉される。分注装置の総容量は、約4mlである。経腸流体は、以下を含む脂肪酸混合物から選択される:
a)油1g当たり360mgのEPA及び240mgのDHA
b)油1g当たり500mgのEPA及び200mgのDHA
c)油1g当たり460mgのEPA及び380mgのDHA
d)油1g当たり150mgのEPA及び500mgのDHA
e)油1g当たり150mgのEPA及び500mgのDHA、並びに脂溶性ビタミンD
f)75〜200mg/mlの量でオメガ-3 PUFAを含有し、総量が約12mlとなる、エマルジョン(したがって、分注装置の総容量はこれよりも大きい)。
オメガ-3脂肪酸で充填されたパウチ分注装置
本発明によるパウチ分注装置を調製し、経腸で対象に送達するための脂肪酸混合物を充填する。パウチの可撓性本体部分は、ポリプロピレン層の間に中間EVOH層を備える、約500μmの総厚を有する多層壁材料を備える。パウチの注出口、すなわち、底部及び出口は、多層壁材料の2つの側壁の間で、パウチ本体に嵌合され、熱を用いてこれらが一緒に封止される。
a)油1グラム当たり500mgのEPA及び200mgのDHAを含む脂肪酸油混合物、並びにポリソルベート20を含む事前濃縮物、
b)少なくとも90パーセントのEPAを含む脂肪酸油混合物、
c)60重量%以上のEPA及びDHA含む脂肪酸油混合物、並びにa-トコフェロール(ビタミンE)。
Claims (20)
- 経腸流体のための手持ち式分注装置であって、
i)経腸流体のリザーバを提供し、経腸流体と適合性のある壁材料を備える、可撓性本体部分と、ここで、可撓性本体部分はそこに配設されている、
ii)供給チューブに接続可能な出口と
を備える、分注装置。 - 栄養分及び医薬品から選択される経腸流体で事前充填されている、請求項1に記載の分注装置。
- 栄養分が、脂肪酸及び脂質並びにそれらの誘導体を含む組成物から選択される、請求項2に記載の分注装置。
- 脂肪酸が、長鎖ポリ不飽和(LC-PUFA)オメガ-3脂肪酸を含む、請求項3に記載の分注装置。
- オメガ-3脂肪酸が、エイコサペンタエン酸(EPA)若しくはドコサヘキサエン酸(DHA)のいずれか、又はそれらの混合物を含む、請求項4に記載の分注装置。
- 脂肪酸又は脂質が、製剤化形態である、請求項3から5のいずれかに記載の分注装置。
- 1回使い切りである、請求項1から6のいずれかに記載の分注装置。
- 1〜30mlの容量を有する、請求項1から7のいずれかに記載の分注装置。
- 可撓性本体部分が、パウチ形式又はチューブ形式を有する、請求項1から8のいずれかに記載の分注装置。
- 可撓性本体部分が、2つのコンパートメントを備える、請求項1から9のいずれかに記載の分注装置。
- 可撓性本体部分の第1のコンパートメントは、栄養分及び医薬品から選択される経腸流体で事前充填され、第2のコンパートメントは、洗浄媒体、第1のコンパートメントの経腸流体とは異なる第2の経腸流体、又はリパーゼで事前充填されている、請求項10に記載の分注装置。
- 可撓性本体部分が、ベローズ型のボトルに似ている、請求項1から8のいずれかに記載の分注装置。
- 出口が、ルアー接続機能又はENFit接続機能を有するように構成される、請求項1から12のいずれかに記載の分注装置。
- 分注装置の壁材料が、多重障壁層を備える、請求項1から13のいずれかに記載の分注装置。
- 壁材料が、経腸流体を酸化から保護する、請求項1から14のいずれかに記載の分注装置。
- 片手で操作可能である、請求項1から15のいずれかに記載の分注装置。
- 可撓性本体部分が、チューブ形式を有する、請求項1から16のいずれかに記載の分注装置。
- 出口が、ENFit接続機能を有する、請求項17に記載の分注装置。
- 経腸流体を対象に投与するための方法であって、
経腸流体で事前充填された分注装置を、供給チューブのポートに取り付けるステップであって、分注装置が、
i)経腸流体のリザーバを提供し、経腸流体と適合性のある壁材料を備える、可撓性本体部分と、ここで、可撓性本体部分はそこに配設されている、
ii)供給チューブに接続可能な出口と
を備える、ステップと、
可撓性本体部分に圧力を加えて、経腸流体を出口を通じてチューブへと押し出すステップと
を含む、方法。 - 経腸流体とともに経腸栄養製品を補給するための方法であって、
経腸流体で事前充填された分注装置を、供給チューブのポートに取り付けるステップであって、分注装置が、
i)経腸流体のリザーバを提供し、経腸流体と適合性のある壁材料を備える、可撓性本体部分と、ここで、可撓性本体部分はそこに配設されている、
ii)供給チューブに接続可能な出口と
を備える、ステップと、
可撓性本体部分に圧力を加えて、経腸流体を出口を通じて供給チューブへと押し出すステップと、
同じ供給チューブに経腸栄養製品を別個又は同時に分注するステップと
を含む、方法。
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PCT/EP2016/051690 WO2016120318A1 (en) | 2015-01-30 | 2016-01-27 | Enteral feeding device |
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US (1) | US20180280234A1 (ja) |
EP (1) | EP3250174A1 (ja) |
JP (2) | JP2018504973A (ja) |
KR (1) | KR20170109598A (ja) |
CN (1) | CN107405254A (ja) |
AU (2) | AU2016212098A1 (ja) |
BR (1) | BR112017016227A2 (ja) |
CA (1) | CA2974758A1 (ja) |
MX (1) | MX2017009842A (ja) |
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-
2015
- 2015-01-30 NO NO20150142A patent/NO20150142A1/en not_active Application Discontinuation
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2016
- 2016-01-27 US US15/545,660 patent/US20180280234A1/en not_active Abandoned
- 2016-01-27 CA CA2974758A patent/CA2974758A1/en not_active Abandoned
- 2016-01-27 AU AU2016212098A patent/AU2016212098A1/en not_active Abandoned
- 2016-01-27 WO PCT/EP2016/051690 patent/WO2016120318A1/en active Application Filing
- 2016-01-27 MX MX2017009842A patent/MX2017009842A/es unknown
- 2016-01-27 JP JP2017540756A patent/JP2018504973A/ja active Pending
- 2016-01-27 KR KR1020177023813A patent/KR20170109598A/ko unknown
- 2016-01-27 EP EP16702898.4A patent/EP3250174A1/en not_active Withdrawn
- 2016-01-27 CN CN201680006945.1A patent/CN107405254A/zh active Pending
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AU2016212098A1 (en) | 2017-08-03 |
EP3250174A1 (en) | 2017-12-06 |
BR112017016227A2 (pt) | 2018-03-27 |
CN107405254A (zh) | 2017-11-28 |
WO2016120318A1 (en) | 2016-08-04 |
MX2017009842A (es) | 2018-02-09 |
CA2974758A1 (en) | 2016-08-04 |
AU2020277222A1 (en) | 2020-12-24 |
KR20170109598A (ko) | 2017-09-29 |
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JP2021112585A (ja) | 2021-08-05 |
US20180280234A1 (en) | 2018-10-04 |
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