JP2009213899A - 血管塞栓形成法 - Google Patents
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Abstract
【解決手段】生体適合性溶媒は、血液に混和あるいは溶解し、かつ供給の間ポリマーを溶解する。生体適合性ポリマーは、生体適合性溶媒には溶け、血液には溶けない。生体適合性溶媒は、血液に接触すると、生体適合性ポリマーが沈殿している塞栓形成組成物から消散する。非粒子物質の存在下でポリマーを沈殿させると、非粒子物質は、ポリマーの沈殿物を生長させる構造的格子として作用することができる。他の実施態様においては、生体適合性ポリマー組成物を、生体適合性プレポリマーを含有する生体適合性プレポリマー組成物と置き換えることができる。
【選択図】なし
Description
本発明は、血管塞栓形成法に係り、特に脈管の病巣部の治療に適する方法に関するものである。この方法では、生体適合性ポリマーと生体適合性溶媒を含有する塞栓形成組成物とともに、金属コイルのような非粒子物質を脈管部位(例えば、動脈瘤腔)に導入する。
本明細書では、以下の刊行物を肩数字を付して引用している。
1 Castaneda-Zuniga,et al.,Interventional Radiology,in Vascular Embolotherapy,Part 1,1:9-32,Williams & Wilkins,Publishers(1992)(非特許文献1)
2 Hopkins,et al.,"Endovascular Treatment of Aneurysms and Cerebral Vasosoams",in"Current Management of Cerebral Aneurysms", Am.Assoc.Neuro.Surgeons,A.Awad,Editor,Chapter II,pp.219-242(1993).(非特許文献2)
3 Pruvo,et al.,"Endovascular Treatment of 16 Intracranial Aneurysms with Microcoils",Neuroragjology,33(supple):S144(Abstract)(1991).(非特許文献3)
4 Mandai,et al.,"Direct Thrombosis of Aneurysms with Cellulose Acetate Polymer",J.Neurosurg.,77:497-500(1992)(非特許文献4)
5 Kinugasa,et al.,"Direct Thrombosis of Aneurysms with Cellulose Acetate Polymer",J.Neurosupg.,77:501-507(1992)(非特許文献5)
6 Casarett and Doull's Toxicology,Amdur et al.,Editors,Pergamon Press,New York,pp.661-664(1975)(非特許文献6)
7 Greff,et al.,U.S.Patent Application SerialNo.08/507,863 for "Novel Compositions for Use in Embolizing Blood Vessels",filed July 27,1995(非特許文献7)
8 Greff,et al.,U.S.Patent Application Serial No.08/508,248 for "Cellulose Diacetate Compositions for Use in Embolizing Blood Vessels",filed July 27,1995(非特許文献8)
9 Kinugasa,etal.,"Early Treatment of Subaraclmoid Hemorrhage After Preventing Rerupture of an Aneurysm",J.Neurosurg., 83:34-41(1995)(非特許文献9)
10 Kinugasa,et al.,"Prophylactic Thrombosis to Prevent New Bleeding and to Delay Aneurysms Surgery",Neurosulg.,36:661(1995)(非特許文献10)
11 Taki,et al.,"Selection and Combination of Various Endovascular Techniques in the Treatment of Giant Aneurysms",J.Neurosurg., 77:37-42(1992)(非特許文献11)
12 German,et al.,New England Jounal of Medicine,250:104-106(1954)(非特許文献12)
13 Rabinowitz,et al.,U.S Patent No.3,527,224,for"Method of Sugically Bonding Tissue Together",issued 9/8/70(非特許文献13)
14 Hawkins,et al.,U.S.Patent No.3,591,676,for"Surgical Adhesive Compositions",issued 7/6/71(非特許文献14)
上述の参照文献のすべては、個々の文献を特別に単独で参照して本明細書にその全部を取り込む必要があるのと同程度に,すべての文献の全体を取り込んだものである。
血管塞栓形成法は、腫瘍の治療、及び動脈瘤、動静脈奇形(AVM)、動静脈痩(AVF)、制御できない出血などの病巣部の治療を含む種々の目的で実施されている。
上述の観点から、脈管部位に塞栓を形成するために使用するポリマー組成物の効果を高めることが継続的に要望されている。
(a)塞栓形成すべき脈管部位に、カテーテルを介して1つの非粒子物質又は複数の前記物質を導入し、かつ、
(b)生体適合性ポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するポリマー組成物を、前記血管部位に、カテーテルを介して供給することを含み、
前記供給は、ポリマーの沈殿物が前記脈管部位で原位置形成し、それによって、血管塞栓を形成し、かつ前記非粒子物質が前記沈殿物内に被包されるような条件下で行われることを特徴とする。
(a)塞栓形成すべき脈管部位に、カテーテルを介して1つの非粒子物質又は複数の前記物質を導入し、かつ、
(b)前記脈血管部位に、生体適合性プレポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するプレポリマー組成物を、カテーテルを介して供給することを含み、
前記供給は、プレポリマーが前記脈管部位で原位置重合し、それによって、血管塞栓を形成し、かつ前記非粒子物質が前記ポリマー内に被包されるような条件下で行われることを特徴とする。
(a)生体適合性ポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するポリマー組成物と、
(b)1つの非粒子物質又は複数のそのような物質と
を含んで成るパーツキットに関するものである。
(a)生体適合性プレポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するプレポリマー組成物と、
(b)1つの非粒子物質又は複数のそのような物質と
を含んで成るパーツキットに関するものである。
キットは、さらに前記ポリマー組成物を供給可能なカテーテルを含むことが好ましい。
他の実施態様においては、キットは、さらに血流を弱めるためのミクロバルーンカテーテルを含む。
本発明は、塞栓形成すべき脈管部位に、非粒子物質とポリマー又はプレポリマー組成物の両方を取り込んで、脈管部位に塞栓形成する方法に関するものである。
用語「塞栓形成」とは、ある物質が血管に注入されるプロセスをいい、これは、例えば、動脈瘤の場合には、動脈瘤嚢を塞ぎ、及び/又は動脈瘤へ血液が流れないようにし、また、AVM's及びAVF'sの場合には、血液の流れを制御/整流するための栓又は血餠を形成して、正常な組織に潅流するようにする。従って、血管塞栓形成は、病巣部に起因する出血(例えば、臓器出血、胃腸出血、脈管出血、及び動脈瘤に係る出血)を防止/制御することにおいて重要である。さらに、塞栓形成術は、血液の供給を中断することによって病的組織(例えば、腫瘍など)を切除することに利用することもできる。
本発明の方法で使用するポリマー又はプレポリマー組成物は、それぞれの成分を加え、得られた組成物を全組成物が実質的に均一になるまで、混ぜ合わせることによって常法で調製される。
そして、上述のような組成物を、哺乳類の血管塞栓形成法において使用する。この方法においては、まず、従来のカテーテル技術によって、非粒子物質(例えば、白金コイル)を、塞栓形成すべき脈管部位に導入する。例えば、Hopkinsら2の脈管部位にそのような物質を導入する従来のカテーテル技術についての議論を参照されたい。
(a)生体適合性ポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するポリマー組成物と、
(b)1つの非粒子物質又は複数のそのような物質と
を含むパーツキットを用いて、簡便に実施される。
(a)生体適合性プレポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するポリマー組成物と、
(b)1つの非粒子物質あるいは複数のそのような物質と
を含むパーツキットを用いて、簡便に実施される。
どちらの場合も、キットはさらに前記ポリマー又はプレポリマー組成物を供給可能なカテーテルを含むことが好ましい。
他の実施態様においては、キットは、さらに血液の流れを減弱させるためのマイクロバルーンカテーテルを含む。
ここに記載した方法は、哺乳類の血管塞栓形成に利用でき、また、順次、病巣部に起因する出血(例えば、臓器出血、胃腸出血、脈管出血、動脈瘤に係る出血)、又は、病的組織(例えば、腫瘍など)の切開に起因する出血を防止/制御するために使用することができる。従って、この方法は、血管塞栓形成が必要なヒト及び他の哺乳類被検体に使用できることがわかる。
また、ここに記載の方法は、例えば、女性及び男性の不妊化にそれぞれ効果的なファロピアン管あるいは精管内で、又は、失禁を治療するために哺乳類の尿道周囲の組織へのバルキング物質の供給のように、脈管以外にも使用することができると考えられる。
特に言及する場合以外は、すべての温度は、セルシウス度である。また、これらの実施例及び他の記載部分において、以下の略語は、以下の意味である。
cc = 立法センチメートル
DMSO = ジメチルスルホキシド
EVOH = エチレンビニルアルコールコポリマー
mm = ミリメートル
μm = ミクロン
アセチルセルロース(アセチル含量は39.7重量パーセント)をDMSOに溶解して、DMSO中のコポリマー濃度が6.8重量パーセントのジアセチルセルロースポリマー組成物を調製した。この溶液にタンタル(10重量パーセント、米国ニューヨーク州ニューヨークのLeico Industriesから入手可能、純度が99.95%、サイズが43μm未満)を加えた。
このタンタル組成物を長時間放置すると、タンタルが沈降する。音波処理も有効であるが、使用の前に十分に混合する必要がある。
EVOH(44モルパーセントのエチレン)をDMSOに溶解して、DMSO中のコポリマー濃度が6.8重量パーセントのEVOHポリマー組成物を調製した。溶解を促進するために、系を一晩中50℃に加熱してもよい。
この実施例の目的は、動脈瘤の治療において、本発明の方法の生体内での適用について説明することである。
具体的には、ラビットの両側から左右相称のアクセス部で処理した。最初の左右相称のアクセス部に、先端を熱して「J」型に形成したマイクロカテーテル(無菌で、コーティング無し、2cm離れた2つの末端バンドを備えている)を配置した。その先端を、0.014インチ(0.0355cm)のDasherガイドワイヤーを用いて動脈瘤内に配置した。動脈瘤の寸法決めをした後、5mm×10cmのGDC-10コイル(カリフォルニア州サンノゼのTarget Therapeuticsから入手可能)をマイクロカテーテルにて、動脈瘤内に配置し、そして、約2分半かけて電解的に取り外した。動脈瘤の末梢部及び中心部は開放されたままであった。
Claims (24)
- 患者の血管内で脈管部位に塞栓形成する方法であって、この方法が、
(a)塞栓形成すべき脈管部位に、カテーテルを介して1つの非粒子物質又は複数の前記物質を導入し、かつ、
(b)生体適合性ポリマー、生体適合性溶媒、及び平均粒子サイズが約10μm以下の非水溶性造影剤を含有するポリマー組成物を、前記血管部位に、カテーテルを介して供給することを含み、
前記供給は、ポリマーの沈殿物が前記脈管部位で原位置形成し、それによって、血管塞栓を形成し、かつ前記非粒子物質が前記沈殿物内に被包されるような条件下で行われることを特徴とする脈管部位に塞栓形成する方法。 - 哺乳類の患者の動脈瘤に塞栓形成する方法であって、この方法が、
(a)動脈瘤腔内に、カテーテルを介して1つの金属コイル又は複数の金属コイルを導入し、かつ、
(b)生体適合性ポリマーと、ジメチルスルホキシドと、タンタル、タンタルオキシド、タングステン、及び硫酸バリウムから成る群より選択された非水溶性造影剤とを含有するポリマー組成物を、カテーテルを介して、前記動脈瘤腔に供給することを含み、前記非水溶性造影剤の平均粒子サイズが10μm以下であり、
前記供給は、ポリマーの沈殿物が動脈瘤腔内で原位置形成し、それによって、動脈瘤を閉塞し、かつ前記金属コイルが前記沈殿物内に被包されるような条件下で行われることを特徴とする動脈瘤に塞栓形成する方法。 - 前記生体適合性溶媒が、ジメチルスルホキシド、エタノール、及びアセトンから成る群より選択されたものである請求の範囲第1項に記載の方法。
- 前記生体適合性溶媒が、DMSOである請求の範囲第3項に記載の方法。
- 前記非水溶性造影剤が、タンタル、タンタルオキシド、タングステン、及び硫酸バリウムから成る群より選択されたものである請求の範囲第1項に記載の方法。
- 前記非粒子物質が、1つの金属コイル又は複数の金属コイルである請求の範囲第1項に記載の方法。
- 前記金属コイルが、白金コイルである請求の範囲第2項又は第5項に記載の方法。
- 前記造影剤が、タンタルである請求の範囲第1項又は第2項に記載の方法。
- 前記ポリマー組成物が、約0.05〜0.3cc/分の速度で、動脈瘤に注入されることを特徴とする請求の範囲第1項又は第2項に記載の方法。
- 前記ポリマー組成物が、少なくとも0.6cc/分の速度で、動脈瘤に注入されることを特徴とする請求の範囲第1項又は第2項に記載の方法。
- (a)生体適合性ポリマー、生体適合性溶媒、及び非水溶性造影剤を含有するポリマー組成物と、
(b)1つの非粒子物質又は複数のそのような物質と
を含んで成るパーツキット。 - (a)生体適合性プレポリマー、及び非水溶性造影剤を含有するプレポリマー組成物と、
(b)1つの非粒子物質又は複数のそのような物質と
を含んで成るパーツキット。 - 前記キットが、さらに生体適合性溶媒を含むものである請求項12に記載のパーツキット。
- 前記生体適合性溶媒が、ジメチルスルホキシド、エタノール、及びアセトンから成る群より選択されたものである請求の範囲第11項又は第13項に記載のパーツキット。
- 前記生体適合性溶媒が、ジメチルスルホキシドである請求の範囲第14項に記載のパーツキット。
- 前記非水溶性造影剤が、タンタル、タンタルオキシド、タングステン、及び硫酸バリウムから成る群より選択されたものである請求の範囲第11項又は第12項に記載のパーツキット。
- 前記非粒子物質が、1つの金属コイル又は複数の金属コイルである請求の範囲第11項又は第12項に記載のパーツキット。
- 前記金属コイルが、白金コイルである請求の範囲第17項に記載のパーツキット。
- 前記キットが、さらに前記ポリマー組成物を供給可能なカテーテルを含むものである請求の範囲第11項又は第12項に記載のパーツキット。
- 前記ポリマー組成物を供給可能なカテーテルが、前記非粒子物質も供給可能なものである請求の範囲第19項に記載のパーツキット。
- 前記キットが、さらに前記非粒子物質を供給可能なカテーテルを含んで成る請求の範囲第19項に記載のパーツキット。
- 患者の血管内で脈管部位に塞栓形成する方法であって、この方法が、
(a)塞栓形成すべき脈管部位に、カテーテルを介して1つの非粒子物質又は複数の前記物質を導入し、かつ、
(b)生体適合性プレポリマー及び造影剤を含有するプレポリマー組成物を、前記脈管部位に、カテーテルを介して供給することを含み、
前記供給は、前記プレポリマーが前記脈管部位で原位置重合し、それによって、血管塞栓を形成し、かつ前記非粒子物質が前記ポリマー内に被包されるような条件下で行われることを特徴とする脈管部位に塞栓形成する方法。 - 前記プレポリマー組成物が、さらに生体適合性溶媒を含有するものである請求の範囲第22項に記載の方法。
- 前記生体適合性溶媒が、ジメチルスルホキシド、エタノール、及びアセトンから成る群より選択されたものである請求の範囲第23項に記載の方法。
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US08/594,574 US5702361A (en) | 1996-01-31 | 1996-01-31 | Method for embolizing blood vessels |
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WO1997027888A1 (en) | 1997-08-07 |
EP2374484A2 (en) | 2011-10-12 |
US5702361A (en) | 1997-12-30 |
US6281263B1 (en) | 2001-08-28 |
AU1753397A (en) | 1997-08-22 |
EP2374484A3 (en) | 2012-01-25 |
US6335384B1 (en) | 2002-01-01 |
JP2000506514A (ja) | 2000-05-30 |
US6017977A (en) | 2000-01-25 |
EP0885024A4 (en) | 2009-05-20 |
JP2012106983A (ja) | 2012-06-07 |
JP4979150B2 (ja) | 2012-07-18 |
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