JP5646813B2 - 結石破砕によらない腎結石の治療方法 - Google Patents
結石破砕によらない腎結石の治療方法 Download PDFInfo
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- JP5646813B2 JP5646813B2 JP2008510072A JP2008510072A JP5646813B2 JP 5646813 B2 JP5646813 B2 JP 5646813B2 JP 2008510072 A JP2008510072 A JP 2008510072A JP 2008510072 A JP2008510072 A JP 2008510072A JP 5646813 B2 JP5646813 B2 JP 5646813B2
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Description
便宜のため、本明細書、実施例、および添付の特許請求の範囲で用いられている特定の用語を以下にまとめる。
結石は、腎臓、膵臓、尿管および胆嚢など、身体の特定部分で発現する。生体結石が、特にそれらが鉱物塩から成る場合に、石と称されることは珍しくない。例えば、胆管系で形成された結石は胆石と呼ばれる。膀胱で生じるものは、多くの場合、膀胱結石として知られている。腎臓に生じる結石は、しばしば腎結石と呼ばれる。結石は、また、尿管にも生じることがある;そこでは、それらは通常、腎臓に由来する結石の不完全な通過の結果である。唾液管または唾液腺に結石が観察される可能性もある。
ある実施形態では、ポリマープラグは、温度、pH変化および/またはイオン相互作用などの1つまたはそれ以上の物理的現象によって原位置(in situ)で生成される。他の実施形態では、本発明の方法に用いられるポリマーは、架橋可能なポリマーである。ある実施形態では、原位置で生成されるポリマープラグは、組織に対して非粘着性の物質である。
本発明は、結石症の治療方法を提供する。1つの実施態様では、管腔の入り口と管腔内の結石との間にポリマーを注入し、管腔を塞ぐポリマープラグを形成する;その後のぜん動運動によって、ポリマープラグが管腔内を進行し、結石を管腔外へと押し出す。
必要に応じて、前記管腔内の前記結石から上流の第2の位置に第2組成物を注入し、その際に前記第2組成物は前記結石と接触せず;その結果、ポリマープラグを形成する;さらに、前記ポリマープラグがぜん動運動によって前記管腔内を進行し、それによって前記結石を前記管腔の外へと押し進める、各工程を含む。
第2組成物を前記結石から上流へ第2の距離を離して前記管腔内に注入し、その際に該第2組成物は前記結石と接触せず;そこで第1組成物と第2組成物が混合され、その結果、ポリマープラグを形成し;
必要に応じて、第3組成物を前記結石から上流へ第3の距離を離して前記管腔内に注入し、その際に該第3組成物は前記結石と接触せず;
さらに、ぜん動運動によって前記ポリマープラグが前記管腔内を進行し、それによって前記結石を前記管腔から押し出す、各工程を含む。
ポリマーをプラスチックチューブに量り取った。所望の濃度を達成するために、25重量%(w%)に関して4を、20質量%(w%)に関して5をその質量に掛け、さらに生理食塩水を加えることによって所望の最終質量を達成した。溶液を4℃の冷蔵庫に置き、通常24時間以内に準備ができた。ゲル化点はブルックフィールド(Brookfield)粘度計での測定値であり、その粘度がプレート/コーン(plate/corn)の範囲(>102Pa・s(102,000cP))を越えた点をゲル化温度とした。
精製ポリマーを50mLの遠心チューブに量り取り、生理食塩水と100%のオムニパーク(Omnipaque)300との1:1混合物を特定の質量%に達するまで加えた。ゲル化点をブルックフィールド(Brookfield)粘度計で測定し、その粘度がプレート/コーン(plate/corn)の範囲を越えた(約102Pa・s(102,000cP)を超えた)点をゲル化温度とした。全ての溶液を37℃にまでさらに加熱し、物質がその粘度範囲を依然として上回り、かつ、ゲルの状態を保っていることを確認した。すべてのゲルが合格であった。
精製ポロキサマー407ゲルの溶解性について、0.5mlのゲルを37℃の生理食塩水で覆ったペトリ皿に注入し、試験を行った。ゲルにメチレンブルーを少量加えて可視化し、ゲルの溶解について視覚的に追跡した。溶解試験には、表面積が最小である球状;および、表面積が最大であるひも状;の2種類の形状のゲルが用いられ、その際、20ゲージのシリンジを用いて、ひも状のポリマーをペトリ皿の底に押し出した。
22.5%の精製されたポロキサマー407ゲルの溶解について、2.5mlのゲルを37℃の尿約100mlで覆ったペトリ皿に注入し、試験を行った。針のないシリンジを用いて、ひも状のポリマーをペトリ皿の底に押し出した。ゲルにメチレンブルーを少量加えて可視化し、ゲルの溶解について視覚的に追った。押し出しの際に、ひも状のポリマーは二つに折れた。ペトリ皿を静置し、ペトリ皿を毎分、視覚的に観察し、ペトリ皿を旋回させて完全に溶解したことを確認した。完全溶解に要した時間(約26分)は、2つのひも状のポリマーでまったく同じであった。
Medallion 5mlシリンジを用いてメチレンブルーで着色した、22.5重量%の精製ポロキサマーPF127を用いた。3匹の各ブタに、焼石膏(Plaster of Paris)でできた人造石を、切開部の2,3センチ上の右の尿管に外科的に移植した。次に、3Fのカテーテル(BioSphere Medical社製のEmbocath HIC 100、ロット# 03W-6930)で、同一の切開部から溶液を石の後方に注入した。注入の直前に、カテーテルに10ccの冷生理食塩水を流し、注入の間、カテーテルを冷えた状態に保ち、ポリマーがカテーテル内で硬化するのを回避した。各方法を、石と切開部の間の尿管に挿入したカメラでモニタした。
本明細書に記載される全ての米国特許および米国特許出願公開を、引用することによって本明細書に援用する。
当業者は、日常的な実験以上のものを用いることなく、本明細書に記載されている本発明の特定の実施形態の多くの等価物を確認できることを認識するであろう。そのような等価物は、添付の特許請求の範囲に含まれることが意図されている。
Claims (37)
- 破砕術によらないで結石症を治療するための組成物であって、逆熱応答性ポリマーを含有する第1組成物を含み、該第1組成物が、結石と接触しないように結石から上流へ所定の距離を離して哺乳類の管腔内に注入されてポリマープラグを形成し、該ポリマープラグがぜん動運動によって管腔内を進行し、それによって結石が管腔から押し出され、その際に破砕術が施されないことを特徴とする組成物。
- 前記逆熱応答性ポリマーが、ブロック共重合体、ランダム共重合体、グラフト重合体、または分岐鎖共重合体であることを特徴とする請求項1記載の組成物。
- 前記逆熱応答性ポリマーが、ブロック共重合体、または分岐鎖共重合体であることを特徴とする請求項2記載の組成物。
- 前記逆熱応答性ポリマーが、精製されたまたは精製されていないポロキサマーまたはポロキサミンであることを特徴とする請求項1記載の組成物。
- 前記逆熱応答性ポリマーが、精製されたまたは精製されていないポロキサミン1107、ポロキサミン1307、ポロキサマー338およびポロキサマー407より成る群から選択されることを特徴とする請求項4記載の組成物。
- 前記逆熱応答性ポリマーが、精製されたまたは精製されていないポロキサマー407であることを特徴とする請求項5記載の組成物。
- 前記第1組成物が、10℃〜40℃の転移温度を有することを特徴とする請求項1から6いずれか1項記載の組成物。
- 前記第1組成物が、15℃〜30℃の転移温度を有することを特徴とする請求項7記載の組成物。
- 前記第1組成物が、5%〜30%の前記逆熱応答性ポリマーを含むことを特徴とする請求項1から8いずれか1項記載の組成物。
- 前記第1組成物が、10%〜25%の前記逆熱応答性ポリマーを含むことを特徴とする請求項9記載の組成物。
- 前記逆熱応答性ポリマーが、1.5〜1.0の多分散指数を有することを特徴とする請求項1から10いずれか1項記載の組成物。
- 前記逆熱応答性ポリマーが、精製されたまたは精製されていないポロキサマーまたはポロキサミンであり、かつ、前記第1組成物が10℃〜40℃の転移温度を有することを特徴とする請求項1記載の組成物。
- 前記逆熱応答性ポリマーが、精製されたまたは精製されていないポロキサマーまたはポロキサミンであり、かつ、前記第1組成物が15℃〜30℃の転移温度を有することを特徴とする請求項1記載の組成物。
- 破砕術によらないで結石症を治療するための組成物であって、
架橋性ポリマーを含有する第1溶液と、リン酸塩、クエン酸塩、ホウ酸塩、コハク酸塩、マレイン酸塩、アジピン酸塩、シュウ酸塩、カルシウム、マグネシウム、バリウム、ストロンチウムまたはそれらの組合せを含有する第2溶液とを含む第1組成物を含み、該第1溶液および第2溶液がそれぞれ、結石と接触しないように結石から上流へ所定の距離を離して哺乳類の管腔内に注入され、第1溶液と第2溶液とが混合されてポリマープラグを形成し、該ポリマープラグがぜん動運動によって管腔内を進行し、それによって結石が管腔から押し出され、その際に破砕術が施されないことを特徴とする組成物。 - 前記第1溶液が、アルギン酸、アルギン酸ナトリウム、アルギン酸カリウム、ジェランナトリウム、ジェランカリウム、カルボキシメチルセルロース、ヒアルロン酸およびポリビニルアルコールから選択されるポリマーを含むことを特徴とする請求項14記載の組成物。
- 前記第1溶液が、アルギン酸、アルギン酸ナトリウム、アルギン酸カリウム、ジェランナトリウムおよびジェランカリウムからなる群より選択されるポリマーを含み;前記第2溶液が、カルシウム、マグネシウム、またはバリウムを含むことを特徴とする請求項14記載の組成物。
- 前記第1溶液が、アルギン酸、アルギン酸ナトリウムまたはアルギン酸カリウムからなる群より選択されるポリマーを含み、前記第2溶液がカルシウムを含むことを特徴とする請求項14記載の組成物。
- 前記第1溶液が、ジェランナトリウムおよびジェランカリウムからなる群より選択されるポリマーを含み、前記第2溶液がマグネシウムを含むことを特徴とする請求項14記載の組成物。
- 前記第1溶液がヒアルロン酸を含み、前記第2溶液がカルシウムを含むことを特徴とする請求項14記載の組成物。
- 前記第1溶液がポリビニルアルコールを含み、前記第2溶液がホウ酸塩を含むことを特徴とする請求項14記載の組成物。
- 前記第1組成物が、結石よりも1cm〜5cm上流の位置に注入されることを特徴とする請求項1から20いずれか1項記載の組成物。
- 前記第1組成物が、結石よりも2cm〜4cm上流の位置に注入されることを特徴とする請求項21記載の組成物。
- 前記第1組成物が、結石よりも3cm上流の位置に注入されることを特徴とする請求項22記載の組成物。
- コントラスト増強剤を含有する第2組成物をさらに含み、該第2組成物が、前記結石と接触しないように結石から上流へ所定の距離を離して前記管腔内に注入されることを特徴とする請求項1から23いずれか1項記載の組成物。
- 前記コントラスト増強剤が、放射線不透過性物質、常磁性体、重原子、遷移金属、ランタニド、アクチニド、色素および放射性核種含有物質より成る群から選択されることを特徴とする請求項24記載の組成物。
- 前記第1組成物の注入位置と前記第2組成物の注入位置の間隔が、3mm未満であることを特徴とする請求項24または25記載の組成物。
- 前記第1組成物の注入位置と前記第2組成物の注入位置の間隔が、1mm未満であることを特徴とする請求項26記載の組成物。
- 前記第1組成物の注入位置と前記第2組成物の注入位置の間隔が、0.5mm未満であることを特徴とする請求項27記載の組成物。
- 前記第1組成物の注入位置と前記第2組成物の注入位置の間隔が、0.1mm未満であることを特徴とする請求項28記載の組成物。
- 前記第1組成物が、経皮的アクセスデバイスを介して前記管腔内に注入されることを特徴とする請求項1から29いずれか1項記載の組成物。
- 前記第1組成物が、カテーテルまたはシリンジを介して前記管腔内に注入されることを特徴とする請求項1から29いずれか1項記載の組成物。
- 前記カテーテルが、ダブルルーメンカテーテルまたはトリプルルーメンカテーテルであることを特徴とする請求項31記載の組成物。
- 前記管腔が、腎臓、胆嚢、尿管、膀胱、膵臓、唾液腺、小腸または大腸であるか、あるいはその一部分であることを特徴とする請求項1から32いずれか1項記載の組成物。
- 前記管腔が、尿管または腎臓であるか、あるいはその一部分であることを特徴とする請求項33記載の組成物。
- 前記結石が、腎結石、膵石、唾石または胆石であることを特徴とする請求項1から32いずれか1項記載の組成物。
- 前記結石が、腎結石であることを特徴とする請求項35記載の組成物。
- 前記哺乳類がヒトであることを特徴とする請求項1から36いずれか1項記載の組成物。
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2015163273A (ja) * | 2005-05-02 | 2015-09-10 | ジェンザイム・コーポレーション | 破砕術によらない結石症の治療のための組成物 |
JP2017070768A (ja) * | 2005-05-02 | 2017-04-13 | ジェンザイム・コーポレーション | 破砕術によらない結石症の治療のための組成物 |
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