JP7035193B2 - ゲル組成物、並びに、その調製方法及び使用方法 - Google Patents
ゲル組成物、並びに、その調製方法及び使用方法 Download PDFInfo
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- JP7035193B2 JP7035193B2 JP2020529189A JP2020529189A JP7035193B2 JP 7035193 B2 JP7035193 B2 JP 7035193B2 JP 2020529189 A JP2020529189 A JP 2020529189A JP 2020529189 A JP2020529189 A JP 2020529189A JP 7035193 B2 JP7035193 B2 JP 7035193B2
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Images
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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
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
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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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- A61L31/145—Hydrogels or hydrocolloids
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- A61B2017/00238—Type of minimally invasive operation
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- 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
- A61M5/14—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
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Description
本開示のいくつかの態様によれば、医療装置は1つ以上のリザーバーを備える。リザーバーは、本明細書の組成物用の容器として機能し得る。好適なリザーバーは、例えば、シリンジ(例えば、手動又は自動注入システムに適合するシリンジバレル)、プラスチックバッグなどの可撓性のポーチ、及び好適な注入針とともに使用するように構成された別の流体容器を含み得る。リザーバーに好適な材料の例は、限定ではないが、環状オレフィンコポリマー、環状オレフィンポリマー、ポリプロピレン、ポリカーボネート、ポリ塩化ビニル、ガラスなどが含まれる。
いくつかの態様では、組成物は、全体の切除処置に亘って組織層の分離を維持し得る。ゲル組成物の一部は、切除工程により除去され得る。組織を切除した後、ゲル組成物の残った部分は、水又は生理食塩水を用いてその部位から洗い流されるか、又は、自然に組織の中に拡散し得る。
(実施例)
以下の実施例は、限定ではなく、本開示を例示することを意図したものである。本開示は、上記説明及び以下の実施例に一致する追加の態様及び実施形態を包含することが理解できる。
この実施例は、本開示の実施形態に係るゲル組成物を調製する為の例示の方法について説明する。1.125gのKelcogelCG-LAジェランガムと、0.01gのFD&C Blue1とを899gの水に加えて予備混合物を形成した。予備混合物は75℃になるまで攪拌しながら加熱した。次に、加熱した予備混合物に、8.1gの塩化ナトリウムと、0.132gの塩化カルシウム2水和物とを添加して混合して、混合物を形成した。次に、混合物を10ccのシリンジのバレルの中に導入した。充填したシリンジは、約122℃で約30分間オートクレーブすることにより滅菌した。
本明細書及び実施例は、例示としてのみ考慮されることを意図したものであり、本開示の真の範囲及び主旨は、以下の請求項の記載により示される。
Claims (15)
- 患者の体内の標的部位に送達する為のゲルの調製方法において、
ジェランガムと水とを組み合わせて予備混合物を形成する工程と、
前記予備混合物を加熱する工程と、
1価カチオンを含む第1の塩と2価カチオンを含む第2の塩とを前記予備混合物に添加して混合物を形成する工程と、
前記混合物をリザーバーに導入する工程と、
前記混合物を冷却して前記リザーバー内でゲルを形成する工程と
を備え、
前記ゲルは生体適合性を有し、且つ、前記リザーバーから針の中を通過して前記標的部位に注入される、方法。 - 前記ゲルは、前記ゲルの総重量に対して重量比で0.01%~2.0%の前記ジェランガムと0.01%~0.1%の前記第2の塩とを含有する、請求項1に記載の方法。
- 前記混合物の前記1価カチオンの前記2価カチオンに対するモル比は、5~200である請求項1又は2に記載の方法。
- 前記第1の塩の前記1価カチオンは、ナトリウム又はカリウムであり、前記第2の塩の前記2価カチオンは、カルシウム又はマグネシウムである、請求項1~3のいずれか一項に記載の方法。
- 前記第1の塩は、塩化ナトリウム又はその水和物からなり、前記第2の塩は、塩化カルシウム又はその水和物からなる、請求項1~4のいずれか一項に記載の方法。
- 前記ゲルは、130s-1のせん断力で0.005Pa・s~0.050Pa・sの粘度を有し、768s-1のせん断力で0.004Pa・s~0.010Pa・sの粘度を有する、請求項1~5のいずれか一項に記載の方法。
- 前記混合物は、240mOsmol/kg~340mOsmol/kgの浸透圧を有する、請求項1~6のいずれか一項に記載の方法。
- 前記予備混合物は、約50℃~約130℃の温度で加熱される、請求項1~7のいずれか一項に記載の方法。
- 前記混合物は、前記リザーバーに導入された際、約50℃~約130℃の温度を有する、請求項1~8のいずれか一項に記載の方法。
- 前記混合物は、前記リザーバーに導入される前に約50℃以下の温度に冷却され、前記方法は、前記リザーバー内で前記混合物を約50℃~約130℃の温度で加熱する工程をさらに備える、請求項1~9のいずれか一項に記載の方法。
- 前記ゲルは、前記リザーバーの断面全体に亘って延びる連続した3次元構造を有する、請求項1~10のいずれか一項に記載の方法。
- 前記予備混合物又は前記混合物に少なくとも1つの着色剤を添加する工程をさらに備える、請求項1~11のいずれか一項に記載の方法。
- 前記ゲルのエンドトキシンレベルは、20エンドトキシンユニット(EU)以下である、請求項1~12のいずれか一項に記載の方法。
- 前記リザーバーは、シリンジのバレルであるか、又は前記リザーバーは、可撓性を有するチューブを介して前記針に連結される、請求項1~13のいずれか一項に記載の方法。
- 前記予備混合物は、約50℃~約90℃に加熱され、前記混合物は、前記予備混合物の前記温度よりも高い温度まで加熱される、請求項1~14のいずれか一項に記載の方法。
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WO2011124381A1 (en) | 2010-04-08 | 2011-10-13 | Merz Pharma Gmbh & Co. Kgaa | Fillers comprising gellan or pectin beads |
WO2017172588A1 (en) | 2016-04-01 | 2017-10-05 | Boston Scientific Scimed, Inc. | Injectable compositions and methods of preparation and use thereof |
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JP2003201257A (ja) * | 2001-11-05 | 2003-07-18 | Seikagaku Kogyo Co Ltd | 上皮膨隆用の医療用組成物 |
BRPI0515191A (pt) * | 2004-08-13 | 2008-07-08 | Angiotech Internac Ag | composição farmacêutica, método para aumentar osso ou substituir perda óssea, método para reduzir a dor associada com cicatriz pós-cirúrgica, método para prevenir aderência cirúrgicas, método para aumento ou reparo de pele ou tecido, método para manter volume em fluido ocular durante cirurgia ocular, método para reduzir a dor associada com osteoartrite, método para tratar doença de refluxo gastroesofágico, método para tratar ou prevenir incontinência urinária, método para tratar ou prevenir incontinência fecal, implante método e dispositivo médico |
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WO2012113529A1 (en) * | 2011-02-22 | 2012-08-30 | Merz Pharma Gmbh & Co. Kgaa | In situ formation of a filler |
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