JP6880060B2 - 注入可能な組成物及びその調製方法並びにその使用方法 - Google Patents
注入可能な組成物及びその調製方法並びにその使用方法 Download PDFInfo
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- JP6880060B2 JP6880060B2 JP2018551250A JP2018551250A JP6880060B2 JP 6880060 B2 JP6880060 B2 JP 6880060B2 JP 2018551250 A JP2018551250 A JP 2018551250A JP 2018551250 A JP2018551250 A JP 2018551250A JP 6880060 B2 JP6880060 B2 JP 6880060B2
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Images
Classifications
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
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- Health & Medical Sciences (AREA)
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- Chemical & Material Sciences (AREA)
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- Medicinal Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Surgery (AREA)
- Anesthesiology (AREA)
- Inorganic Chemistry (AREA)
- Neurosurgery (AREA)
- Dermatology (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicinal Preparation (AREA)
Description
「からなる(comprising)」、「からなる(comprises)」又は同単語の派生型は、非排他的な包含をカバーすることを意図したものであり、例えば、一群の要素からなる工程、方法、構成要素、物品又は装置は、その要素のみを含むのではなく、明示されていない、即ち同工程、方法、構成要素、物品又は装置に本質的でないものも含む。「例示的」という用語は、「理想的」ではなく「例」の意味で使用される。
少なくとも1つのゲル化剤は、天然(植物性粘性物質及び微生物性粘性物質等の天然粘性物質)又は合成した性質のものであり、陰イオン性、陽イオン性、又は中性であってもよい。本願発明の組成物に好適なゲル化剤の非限定的な例には、ジェランガム、キサンタンガム、アラビアガム、グアーガム、ローカストビーンガム、アルギン酸及びカラギーナンなどの多糖類が含まれる。
調製されて円筒部32内でゲルにされ、シリンジ30は、注入されるゲルの量を自動調節する注入システム45のチャネル47の中に挿入される。シリンジ30の遠位端38は、カテーテル39を介して注入針(図1Aの注入針50に類似)に結合される。本願発明のいくつかの態様では、プランジャー34は、注入システム45の一部を形成して、円筒部32は、注入システム45に結合される別の構成要素、例えば、交換可能なカートリッジである。例えば、組成物15は、注入システム45のプランジャー構成要素に適合可能な近位取り付け部を有する交換可能なカートリッジである円筒部32の中に調製される。
以下の実施例は、限定ではなく本願発明を説明することを意図している。本願発明は、上記説明や下記実施例に一致する追加の態様及び実施形態を包含すると理解される。
以下の方法に従って、表1に係る組成物A−Cを調製した。ジェランガム(ジェルザンシーエム,Gelzan(登録商標)CM,CP ケルコ)とエリオグラウシン二ナトリウム塩(FD&C Blue1,シグマアルドリッチ)をリン酸緩衝生理食塩液(PBS)に添加してマグネチックスターラーとバーとを用いて連続して攪拌した。PBS溶液は、0.138MのNaClを形成する為に1000mlの脱イオン水に1袋のPBSパウダー(シグマアルドリッチ)を溶解することにより調製した。ジェランガム/塩/PBS混合液は、攪拌しながら沸騰させると、外見上やや濁った青色から透明な青色に変化した。溶液は、攪拌しながら室温(〜25℃)まで冷却すると粘性を有する流体となった。
実施例1に従って調製したジェランガム組成物A−Cを含むシリンジを注入針(ボストンサイエンティフィックインタージェクト(BostonScientificInterject(登録商標)),23ゲージ針)に結合して、インストロン5564ユニバーサル試験機(Instron5564UniversalTestingMachine)と500Nロードセルとカスタム固定とを用いて3mm/s(流速0.5ml/s)で注入した。計測した最大負荷の値は、表2に示されているように、ジェランガム濃度によって変化した。
Claims (17)
- 患者の標的部位に送達する為の組成物の調製方法において、
混合物を形成する為にジェランガムと少なくとも1つの塩と水とを混合する工程と、
前記混合物を加熱する工程と、
前記混合物を容器に導入する工程と、
前記混合物を容器内部で冷却して前記容器内部に連続した三次元構造を有するゲルを形成する工程とを備え、
前記組成物は、生体適合性を有し、且つ前記容器から針を介して前記標的部位に注入可能である、方法。 - 前記組成物は、前記組成物の全重量に対して0.01重量%〜2.0重量%のジェランガムを含有する、請求項1に記載の方法。
- 前記組成物は、前記組成物の全重量に対して0.05重量%〜0.5重量%のジェランガムを含有する、請求項1又は2に記載の方法。
- 前記混合物は、70℃〜130℃の温度で加熱後に、前記容器の中に導入される、請求項1〜3のいずれか一項に記載の方法。
- 前記容器内部に導入された際の前記混合物の温度は、70℃〜130℃の範囲である、請求項1〜4のいずれか一項に記載の方法。
- 前記混合物を前記容器の中に導入する前に前記混合物を冷却する工程と、前記混合物を前記容器内部で70℃〜130℃の範囲の温度で加熱する工程をさらに備える、請求項1〜4のいずれか一項に記載の方法。
- 前記混合物を加熱することにより、前記混合物を滅菌する、請求項1〜6のいずれか一項に記載の方法。
- 前記容器は、シリンジの円筒部である、請求項1〜7のいずれか一項に記載の方法。
- 前記容器は、可撓性の小袋からなる、請求項1〜7のいずれか一項に記載の方法。
- 前記容器は、可撓性のチューブによって前記針に結合されている、請求項1〜9のいずれか一項に記載の方法。
- 前記組成物は、着色剤を含有する、請求項1〜10のいずれか一項に記載の方法。
- 前記ゲルの連続した三次元構造は、前記容器の断面の寸法全体に亘って広がっている、請求項1〜11のいずれか一項に記載の方法。
- 組成物の全重量に対して0.05重量%〜0.5重量%のジェランガムと少なくとも1つの塩と水とを含有する前記組成物を収容する容器を備え、前記組成物は、前記容器内で連続した三次元構造を有するゲルの形態をなし、生体適合性を有し、且つ前記容器から針の中を通って標的組織に注入可能である、医療装置。
- 前記医療装置は、前記容器と、前記針と、前記容器を前記針に結合する可撓性チューブとからなり、前記容器は、シリンジの円筒部又は可撓性の小袋である、請求項13に記載の医療装置。
- 前記医療装置は、20エンドトキシンユニット(EU)以下のエンドトキシンを含む、請求項13又は14に記載の医療装置。
- 前記容器は、シリンジ筒である、請求項13〜15のいずれか一項に記載の医療装置。
- 前記ゲルは、前記容器を反転させた時に、その形状を維持する、請求項13〜16のいずれか一項に記載の医療装置。
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---|---|---|---|---|
CA2274661A1 (en) * | 1996-12-10 | 1998-06-18 | Reprogenesis, Inc. | Improved hydrogel for tissue engineering |
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US20050220882A1 (en) * | 2004-03-04 | 2005-10-06 | Wilson Pritchard | Materials for medical implants and occlusive devices |
US20060040894A1 (en) * | 2004-08-13 | 2006-02-23 | Angiotech International Ag | Compositions and methods using hyaluronic acid |
US20080132991A1 (en) * | 2006-11-30 | 2008-06-05 | Leonard Pinchuk | Method for Ionically Cross-Linking Gellan Gum for Thin Film Applications and Medical Devices Produced Therefrom |
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US20130089585A1 (en) * | 2010-04-08 | 2013-04-11 | Merz Pharma Gmbh & Co., Kgaa | Filler comprising beads |
US20120301436A1 (en) * | 2011-05-27 | 2012-11-29 | Taipei Medical University | Polyelectrolyte complex gels and soft tissue augmentation implants comprising the same |
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US20160228140A1 (en) * | 2013-06-26 | 2016-08-11 | Vicut Medical Devices Ltd. | Device, kit and method for prolonged lifting of a tissue during endoscopic procedure |
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US20220088296A1 (en) | 2022-03-24 |
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CN113995713A (zh) | 2022-02-01 |
CA3019131A1 (en) | 2017-10-05 |
EP4019004A1 (en) | 2022-06-29 |
WO2017172588A1 (en) | 2017-10-05 |
EP3435975B1 (en) | 2021-09-15 |
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US20170281862A1 (en) | 2017-10-05 |
CA3019131C (en) | 2023-09-26 |
CN109219434B (zh) | 2023-05-26 |
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AU2021203072A1 (en) | 2021-06-10 |
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AU2022204886A1 (en) | 2022-07-28 |
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AU2021203072B2 (en) | 2022-08-11 |
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