JP2019502758A - 粘度および安定性が改善された超音波ゲル - Google Patents
粘度および安定性が改善された超音波ゲル Download PDFInfo
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- JP2019502758A JP2019502758A JP2018554607A JP2018554607A JP2019502758A JP 2019502758 A JP2019502758 A JP 2019502758A JP 2018554607 A JP2018554607 A JP 2018554607A JP 2018554607 A JP2018554607 A JP 2018554607A JP 2019502758 A JP2019502758 A JP 2019502758A
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- A61B17/225—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
- A61B17/2251—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
- A61B2017/2253—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient using a coupling gel or liquid
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Abstract
Description
本願は、「Viscosity and Stability Modified Ultrasound gel」なる発明の名称で2016年1月10に出願された、出典明示して本明細書の一部とみなす、米国仮特許出願番号62/276,927に基づく優先権を主張する。
本願は超音波ゲル、より詳細には内部および/または口腔的に安全に使用し得る超音波ゲルに関する。
a)少量のCNCの添加は、ガンマ線殺菌を行った後のカルボマー系超音波ゲルの高い粘度を維持することができる。CNCの添加は、照射後の貯蔵寿命試験の間に観察されるゲルの粘度の低下を減じるまたは防ぐことができる。また、照射の前および後に高い粘度を達成するために、低濃度のCNCの使用はあまり架橋度が高くない架橋型Carbopol(商標)の使用を許容する。例えば、種々のグレードのCarbopols(商標)が入手可能であり、高い架橋度のものも存在する。
b)CNC(カルボマーを含まない)および水のみからなるゲルは、ガンマ線に照射した後にゲル粘度を増加した。
a)カルボマー系超音波ゲルにおけるさらなるゲル化剤としてのCNCの使用。カルボマーゲル化剤(Carbopol(商標)のような)をベースとする超音波ゲルにおけるさらなる成分(数質量%を添加する)としてのCNCの使用は、ゲルの適当な音響特性を維持しつつ得られるゲルの粘度を増加し得る;
b)ガンマ線殺菌によって起こる粘度の損失に対してカルボマー系超音波ゲルの保護剤としてのCNCの使用。CNCをカルボマーゲル化剤(Carbopol(商標)のような)をベースとする超音波ゲルに添加し、そのゲルをガンマ線を用いて殺菌した場合、得られる照射後のゲルはCNCを添加しなかった照射後のゲルと比較して十分に高い粘性(例えば、粘性として2倍)を維持することができる;および
c)ガンマ線殺菌の間に照射した場合のCNCゲル(カルボマーを含まず、CNCのみ)の増粘挙動。CNCゲル(カルボマーを含まない)はガンマ線を照射した場合にその粘度を増加し得、これは、照射後に高い粘度の超音波ゲルを得る方法、および照射線量および照射前ゲル中の初期CNC濃度を制御することによって照射後の粘度を制御する方法を提供し得る。
a)「初期ゲル」処方(ゲル100g当たり):1.3g Carbopol(商標)、4.29g 18% KOH、0.5g キシリトール、0.1g ソルビン酸カリウム(任意)、および残部 脱イオン水、すべて減圧下で混合;および
b)「調節したゲル」処方(ゲル100g当たり):1.8g Carbopol(商標)、9.5g グリセリン、4.29g KOH、0.5g キシリトール、0.1g ソルビン酸カリウム(任意)、および残部 脱イオン水、すべて減圧下で混合。
a)使用する溶媒/安全性:カルボマー内の差の顕著な領域がそれを合成するために使用する溶媒系である。
1. ゲルを一定時間の間に潜在的に摂取し得る、口腔内の使用または内部空洞超音波法について安全である(口腔用途については、患者はこのゲルを毎日数年間にわたって摂食し続けるであろう)。
また、グリセリンは、ゲルの全音響インピーダンスを増加するために、ならびにガンマ線に曝露した後の粘度の低下からゲルを保護するために用いることができる。
材料
材料:精製水 1100 g、Carbopol 974P NF 13g、水酸化カリウム 18g、Club House(商標)緑色食品色 1 mL、キシリトール 5g、ソルビン酸カリウム 1g、グリセリン 50g。
製造
幾つかの実施形態において、混合工程は、ゲル中の気体/気泡を最小限化するように減圧下で行うことができる。水または溶液を予め脱気していない場合、その水または溶液はゲル中の気体/気泡を最小限化するように使用する前に脱気することができることに注記されたい。
結果:粘度試験および安定性
知見:CNCおよびGELの粘度
表1に概略するように、ゲル試料の生成、照射および粘度試験に関する観察を行った。
2)CNCは、グリセリンを含むかまたは含まないCarbopol(商標)ゲルの場合においては、ガンマ線による崩壊に対して架橋保護を提供することができる;
3)CNCおよびグリセリンの両方は「調節したゲル」処方に添加して、照射後の粘度における最小限の低下を有するゲルを生じることができる;
4)グリセリンは、ゲルの音響インピーダンスを増大し得るが、グリセリンを添加することは照射後のゲル粘度を維持する必要がある場合がある。しかしながら、CNCを添加することは音響インピーダンスを変化せず、ゲル粘度を保護するだけのようである;
5)純粋なCNCゲルは軟組織に対する結合に高すぎる音響インピーダンスを示し得るが、15%未満のCNCの添加は粘性ゲルおよび望ましい音響インピーダンスの両方を生じ得る;
6)ある種の濃度のCNCゲルは照射後の粘度を増大することを示し得る(例えば、表1のCNC試料11の結果を参照されたい);および
7)グリセリンを添加することはゲルに甘味を加えるが、CNCを添加しても味は変化しない。
結論:結晶ナノセルロース(CNC)およびゲルの粘度
幾つかの実施形態において、CNCは「調節したゲル」処方に添加して全体のゲルの粘度を増大し、ならびに照射の間のゲルの崩壊を防ぎ、照射後の全体的な粘度において遙かに小さな低下につながり得る。幾つかの実施形態において、グリセリンおよびCNCの両方は、照射による崩壊からより良好に保護するために初期処方に一緒に添加することができる。
以下の参考文献を出典明示して本明細書の一部とみなす。
1.米国仮特許出願番号61/740,408, entitled 「Internal Ultrasound Gel」, filed on December 20, 2012.
2.PCT国際出願番号: PCT/CA2013/001058, Pub. No.: WO/2014/094127, entitled 「Internal Ultrasound Gel」, filed on December 18, 2013.
3.Modification and Characterization of Biodegradable Methylcellulose Films with TrimethylolpropaneTrimethacrylate (TMPTMA) by γ Radiation: Effect of Nanocrystalline Cellulose. J. Agric. Food Chem., 60(2012): 623−629;
4.Mechanical and Barrier Properties of Nanocrystalline Cellulose Reinforced Poly(caprolactone) Composites: Effect of Gamma Radiation. J. Applied Polym. Sci., 129(2013): 3038−2046;
5.Radiation grafting on natural films. Rad Phys. And Chem., 94(2014): 88−92.
6.米国特許第8,618,1752号, Ultrasound medical gel composition etherified hydroxyethylcellulose;
7.米国特許第3,108,890号, Aqueous Cellulosic Compositions and Methods of Making Same;
8.Comparison of Gamma Radiation Crosslinking and Chemical Crosslinking on Properties of Methylcellulose Hydrogel. Engineering Journal, Col 16(4): pp. 15−28 (Rimdusit et al.).
9.Sultana, Islam, Dafader and Haque. Preparation of carboxymethyl cellulose/acrylamide Copolymer hydrogel using gamma radiation and Investigation of its swelling behavior. Journal of Bangladesh Chemical Society, Vol. 25(2), 132−138, 2012.
10.Xiaoyun Qiu and Shuwen Hu. 「Smart」 Materials Based on Cellulose: A Review of the
11.Preparations, Properties, and Applications. Materials 2013, 6, 738−781; doi:10.3390/ma6030738
12.Chengjun Zhou, Qinglin Wua, Yiying Yue, Quanguo Zhang. Application of rod−shaped cellulose nanocrystals in polyacrylamide hydrogels. Journal of Colloid and Interface Science 353 (2011) 116−123
13.B. L. Peng, N. Dhar, H. L. Liu, and K. C. Tam. Chemistry and Applications of Nanocrystalline Cellulose and its Derivatives: a Nanotechnology Perspective. The Canadian Journal of Chemical Engineering Volume 9999, 2011.
14.Chengjun Zhou and Qinglin Wu. Recent Development in Applications of Cellulose Nanocrystals for Advanced Polymer−Based Nanocomposites by Novel Fabrication Strategies.
15.Alessandro Sannino, Christian Demitri and Marta Madaghiele. Biodegradable Cellulose−based Hydrogels: Design and Applications. Materials 2009, 2, 353−373; doi:10.3390/ma2020353
16.カナダ特許出願番号2,770,837
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20.米国特許出願番号2010/0124732
21.米国特許出願番号2012/0040312
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26.米国特許第7,269,873号
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29.Makinen, K. K. and Soderling, E. 1981. 「Effect of Xylitol on Some Food−Spoilage Microorganisms」, Journal of Food Science. 46:950.
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Claims (29)
- 水;
水をゲルまで粘度を高める増粘剤;
ゲルの粘度を設定し、ゲルのpHレベルを調節する中和剤;
放射線曝露によるゲル粘度の変化を減じる粘度剤;および
ゲルを保存する保存剤;
を含む内部超音波ゲルであって、
ゲルが軟組織に類似した音響インピーダンスを有し、内部的または口腔的に安全に使用できることを特徴とする、内部超音波ゲル。 - 粘度剤がナノ粒子を含む、請求項1に記載の超音波ゲル。
- 粘度剤がCNCを含む、請求項1または2のいずれかに記載の超音波ゲル。
- 粘度剤がグリセリンを含む、請求項1〜3のいずれか1項に記載の超音波ゲル。
- 増粘剤がカルボマーを含む、請求項1に記載の超音波ゲル。
- カルボマーがCarbopol(商標)を含む、請求項5に記載の超音波ゲル。
- Carbopol(商標)がカルボマーホモポリマータイプB(Carbopol(商標)974P NF)を含む、請求項6に記載の超音波ゲル。
- 中和剤が水酸化カリウム、水酸化ナトリウム、およびトリエタノールアミンからなる群から選択される塩基を含む、請求項1〜7のいずれか1項に記載の超音波ゲル。
- ゲルのpHレベルが5.8〜6.4である、請求項1〜8のいずれか1項に記載の超音波ゲル。
- 保存剤が食品等級の保存剤を含む、請求項1〜9のいずれか1項に記載の超音波ゲル。
- 保存剤がソルビン酸カリウムを含む、請求項1〜10のいずれか1項に記載の超音波ゲル。
- さらに、歯科微生物の増殖を阻害する歯科剤を含む、請求項1〜11のいずれか1項に記載の超音波ゲル。
- 歯科剤が糖アルコールである、請求項12に記載の超音波ゲル。
- 糖アルコールがキシリトールである、請求項13に記載の超音波ゲル。
- さらに、着色ゲル用の着色料を含む、請求項1〜14のいずれか1項に記載の超音波ゲル。
- 超音波で組織をイメージングする方法であって:
超音波イメージング装置を準備し、装置は超音波を発するトランスデューサを含み;
請求項1〜15のいずれか1項に記載の超音波ゲルをトランスデューサと撮像すべき組織との間に適用し;
撮像すべき組織に近接させてトランスデューサを位置決めし;次いで
ゲルを通して超音波を発して組織を撮像する
ことを含む方法。 - 超音波で組織を処理する方法であって:
超音波処理装置を準備し、装置は超音波を発するトランスデューサを含み;
請求項1〜15のいずれか1項に記載の超音波ゲルをトランスデューサと処理すべき組織との間に適用し;
処理すべき組織に近接させてトランスデューサを位置決めし;次いで
ゲルを通して超音波を発して組織を処理することを含む、方法。 - 超音波を組織に適用するキットであって、キットが請求項1〜15のいずれか1項に記載の超音波ゲル、およびゲルを使用するための指示を含むキット。
- ポリマー系超音波ゲルの粘度を保護する方法であって:
水;水をゲルまで粘度を高める増粘剤;ゲルの粘度を設定し、ゲルのpHレベルを調節する中和剤;およびゲルを保存する保存剤を含む超音波ゲルを準備し;ゲルは軟組織に類似した音響インピーダンスを有し、内部的または口腔的に安全に使用することができ;
粘度剤を超音波ゲルに添加して、放射線曝露による超音波ゲルの粘度の変化を減じ;次いで
超音波ゲルを放射線に曝露し;
放射線に対する曝露による超音波ゲルの粘度における低下を、粘度剤によって減じる
ことを含む方法。 - 粘度剤がナノ粒子を含む、請求項19に記載の方法。
- 粘度剤がCNCを含む、請求項19または20に記載の方法。
- 粘度剤がグリセリンを含む、請求項19〜21のいずれか1項に記載の方法。
- ゲルの粘度を変化する方法であって:
水を含むゲル前駆体を準備し;
粘度剤をゲル前駆体に添加することによって混合物を生成し、粘度剤は放射線曝露によるゲル前駆体の粘度を変化し;次いで
混合物を放射線に曝露する;ことを含み、
放射線に対する曝露による混合物の粘度変化の変化を粘度剤によって引き起こすことを特徴とする、方法。 - 粘度剤がナノ粒子を含む、請求項23に記載の方法。
- 粘度剤がCNCを含む、請求項23または24に記載の方法。
- 粘度剤がグリセリンを含む、請求項23〜25のいずれか1項に記載の方法。
- 請求項19〜26のいずれか1項に記載の方法によって製造した内部超音波ゲル。
- 放射線に対する曝露による超音波ゲル粘度の変化の減少を生じる、粘度剤としてのCNCの使用。
- 放射線に対する曝露によるヒドロゲル粘度の変化に変化を引き起こす粘度剤としてのCNCの使用。
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2016
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AU2016383713B2 (en) | 2023-10-12 |
US20200188538A1 (en) | 2020-06-18 |
NZ744196A (en) | 2021-08-27 |
CA3010644A1 (en) | 2017-07-13 |
EP3400026A1 (en) | 2018-11-14 |
AU2016383713A1 (en) | 2018-07-26 |
WO2017117650A1 (en) | 2017-07-13 |
JP6954923B2 (ja) | 2021-10-27 |
US11890355B2 (en) | 2024-02-06 |
CN108778346B (zh) | 2022-02-11 |
CN108778346A (zh) | 2018-11-09 |
EP3400026A4 (en) | 2019-08-14 |
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