JP2005537070A - 塞栓術 - Google Patents
塞栓術 Download PDFInfo
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Abstract
Description
別の態様では、本発明は粒子の製造方法を特徴とする。この方法は、ポリマー、ゲル化化合物、および強磁性材料を含有する混合物を形成する工程と、ポリマー性基材およびポリマー性基材中の強磁性材料を含有する粒子を形成するためにその混合物を処理する工程とを備える。粒子は約10μm〜約3,000μmの平均直径を有する。
する工程とを備える。粒子は約10μm〜約3,000μmの平均直径を有する。粒子は、一定密度の大径孔を有する内部領域と、一定密度の大径孔を有する表面領域とを有し、内部領域の大径孔の密度は表面領域の大径孔の密度より大きい。
強磁性材料は、例えば、金属(例えば、遷移金属)、金属合金、金属酸化物、ソフトフェライト、希土類磁石合金、またはアモルファスおよび非土類(non-earth )の合金であることが可能である。強磁性材料の例には、磁鉄鉱、ニッケル、コバルト、鉄、およびミューメタルが含まれる。
材料(強磁性材料、放射線不透過性材料、MRI可視材料)は、約2μm〜約20μm(例えば、約10μm〜約12μm)の直径を有することが可能である。
ポリマー性基材と材料(強磁性材料、放射線不透過性材料、MRI可視材料)とを含有する粒子は、少なくとも約100μmの直径(例えば、少なくとも約500μm、少なくとも約1,000μm、少なくとも約1,500μm、少なくとも約2,000μm、多くとも約2,500μm)と、多くとも約2,000μmの直径(例えば、多くとも約1,500μm、多くとも約1,200μm、多くとも約1,000μm、多くとも約500μm)とのうちの少なくとも1つを有することが可能である。例えば、そのような粒子は、約100μm〜約500μm、または約500μm〜約1,200μmの直径を有することが可能である。
ポリマー性基材は、多糖類(例えば、アルギン酸塩)を含有することが可能である。
ポリマー性基材と材料(強磁性材料、放射線不透過性材料、MRI可視材料)とを含有する粒子は、重量で約0.1%〜約90%(例えば、重量で約0.1%〜約75%)の強磁性材料、MRI可視材料、または放射線不透過性材料を含有することが可能である。
ある方法において粒子を作製するために用いられるゲル化化合物は、多糖類(例えば、アルギン酸塩)であることが可能である。
塞栓粒子を投与するある方法には、カテーテルによる投与が含まれることが可能である。
る。
方法は、体組織を焼灼する工程を備えることが可能である。
幾つかの実施態様では、粒子を加熱する工程は、体組織を加熱する。
幾つかの実施態様では、粒子は生体適合性を有した1つ以上の成分を含有することが可能である。一例として、粒子は1つ以上の生体適合性ポリマー(例えば、1つ以上の生体吸収性ポリマー)を含有することが可能である。別の例として、粒子は生体適合性である1つ以上の材料(例えば、1つ以上の放射線不透過性材料、1つ以上の強磁性材料、1つ以上のMRI可視材料)を含有することが可能である。ある実施態様では、粒子は1つ以上の生体適合性ポリマー(例えば、1つ以上の生体吸収性ポリマー)と、1つ以上の追加の生体適合性材料(例えば、1つ以上の放射線不透過性材料、1つ以上の強磁性材料、1つ以上のMRI可視材料)とを含有することが可能である。
特徴および長所は、発明を実施するための最良の形態、図面、および特許請求の範囲にて認められる。
ら0.9rまでの領域の孔16の平均寸法の約5%以下(例えば、約1%以下、約0.3%以下)である。幾つかの実施態様では、粒子10の最大の孔は、粒子10の直径の約1%以上(例えば、約5%以上、約10%以上)の範囲の寸法を有する。粒子10の孔16の寸法は、粒子10の断面を観察することによって測定可能である。不規則的な形状(非球状)の孔では、最大の観察断面を用いる。
れることが可能である。粒子は比較的密集した閉塞塊を形成可能である。体内での粒子の圧縮は、一般に、管腔中の体液流から与えられる力によって決定される。幾つかの実施態様では、粒子の圧縮プロファイルによって圧縮が制限されて、所定の直径を閉塞するために必要な粒子数は減少され得る。
書(代理人事件番号第01194−465001号)に説明されており、この出願を引用によって本明細書に援用する。
の身体の外部にあることが可能であり、また内部で用いられることも可能である。幾つかの場合では、外部磁気源および内部磁気源の両方が用いられて、粒子を移動させることが可能である。内部磁気源の例は、磁気カテーテルである。磁気カテーテルは、「磁気的に強化された注入カテーテル(Magnetically Enhanced Injection Catheter)」と題した2002年3月29日出願の米国特許出願第10/108,874号明細書に説明されており、この出願を引用によって本明細書に援用する。外部磁気源の例は、マグネティックワンド(magnetic wand )である。
なく、X線透視検査を実施可能である。
合性材料(例えば、磁鉄鉱)であることが可能である。
図2Aには、粒子10を製造するための装置系の一実施態様が示されている。この装置系は、流量制御装置300、液滴生成装置310、ゲル化容器320、反応容器330、ゲル溶解室340、およびフィルタ350を有する。図2Bに示されるように、流量制御装置300は、基材12の材料(例えば、1つ以上のポリマー)とゲル化前駆体(例えば、アルギン酸塩)を含有する溶液を粘度制御装置305に送達する。粘度制御装置305は、液滴生成装置310へ送達する前に、溶液を加熱して粘度を減少させる。溶液は液滴生成装置310のノズルのオリフィスを通過して、溶液の液滴を形成する。その後、液滴はゲル化容器320へ案内されて、そこで液滴はゲル化剤(例えば、塩化カルシウム)と接触して、ゲル形成によって安定化される。ゲル安定化された液滴は、ゲル化容器320から反応容器330に移送されて、そこでゲル安定化された液滴中のポリマーが反応(例えば、架橋)して、前駆体粒子を形成する。前駆体粒子はゲル溶解室340へ移送されて、そこでゲル化前駆体が除去される。その後、粒子はフィルタ350で濾別され残物を取り除かれて、粒子を含有する塞栓組成物として滅菌され、および容器に詰められる。粒子の作製方法は、例えば、「塞栓術」と題した2003年8月8日出願の米国特許出願明細書(代理人事件番号第01194−465001号)に説明されており、この出願を引用によって本明細書に援用する。
の低い静脈へ血液が短絡することによって、血液が迂回する領域の低酸素症および栄養失調を生じる。幾つかの実施態様では、粒子を含有する組成物は、病状を予防的に治療するために用いられることが可能である。
m以下、約1,200μm以下、約900μm以下、約700μm以下、約500μm以下、約400μm以下、約300μm以下、約100μm以下)および約10μm以上の平均直径(例えば、約100μm以上、約300μm以上、約400μm以上、約500μm以上、約700μm以上、約900μm以上、約1,200μm以上、約1,500μm以上、約2,000μm以上、約2,500μm以上)のうちの少なくとも1つを有する。患者に送達される粒子の平均直径の典型的な範囲には、約100μm〜約300μm、約300μm〜約500μm、約500μm〜約700μm、および約900μm〜約1,200μmが含まれる。一般に、塞栓組成物において患者に送達される粒子は、個々の粒子直径の範囲のほぼ中央である平均直径と、約20%以下の分散(例えば、約15%以下、約10%以下)とを有する。
一例として、幾つかの実施態様では、粒子は異なる種類の材料の組合せを有する(例えば、1つ以上の強磁性材料および1つ以上の放射線不透過性材料であり、1つ以上の放射線不透過性材料および1つ以上のMRI可視材料であり、1つ以上の強磁性材料および1つ以上のMRI可視材料であり、1つ以上のMRI可視材料、1つ以上の強磁性材料、および1つ以上の放射線不透過性材料である)。
中の米国特許出願第10/615,276号明細書に説明されており、この出願を引用によって本明細書に援用する。
によって)形成可能である。粒子の形状化は、例えば、「所望の形状および直径を有する化学的架橋粒子の形成(Fo rming a Chemically Cross-Linked Particle of a Desired Shape and Diameter)」と題した2003年3月28日出願の同時継続中の米国特許出願
第10/402,068号明細書に説明されており、この出願を引用によって本明細書に援用する。
材料、および1つ以上の放射線不透過性材料のうちの少なくとも1つは、粒子の表面に結合されることが可能である(例えば、化学的結合を通じて)。
さらなる例として、幾つかの実施態様では、粒子は孔を有することなく形成されることが可能である(無孔粒子)。
Claims (43)
- ポリマー性基材と、前記ポリマー性基材中に分配された強磁性材料とを有し、約10μm〜約3,000μmの直径を有する粒子。
- 前記強磁性材料は、遷移金属、金属合金、および金属酸化物からなる群から選択される請求項1に記載の粒子。
- 前記強磁性材料は、磁鉄鉱、ニッケル、コバルト、鉄およびミューメタルからなる群から選択される請求項1に記載の粒子。
- 前記強磁性材料は磁鉄鉱を含有する請求項1に記載の粒子。
- 前記強磁性材料は、ソフトフェライトと、希土類磁石合金と、アモルファスおよび非土類の合金とからなる群から選択される請求項1に記載の粒子。
- 前記強磁性材料は、粒子、繊維、薄片、および粉体からなる群から選択される少なくとも1つの物品の形状である請求項1に記載の粒子。
- 前記物品は約2μm〜約20μmの直径を有する請求項6に記載の粒子。
- 前記強磁性材料は前記ポリマー性基材中全体にほぼ均一に分配されている請求項1に記載の粒子。
- 前記ポリマー性基材は多糖類を含有する請求項1に記載の粒子。
- 前記ポリマー性基材は、ポリビニルアルコール、ポリアクリル酸、ポリメタクリル酸、ポリビニルスルホン酸、カルボキシメチルセルロース、ヒドロキシエチルセルロース、置換セルロース、ポリアクリルアミド、ポリエチレングリコール、ポリアミド、ポリウレア、ポリウレタン、ポリエステル、ポリエーテル、ポリスチレン、多糖類、ポリ乳酸、ポリエチレン、ポリメタクリル酸メチル、ポリカプロラクトン、ポリグリコール酸、ポリ(乳酸−グリコール酸)共重合体、およびそれらの組合せからなる群から選択される要素を含有する請求項1に記載の粒子。
- 治療剤をさらに含有する請求項1に記載の粒子。
- 前記ポリマー性基材は第1のポリマーと第2のポリマーとを含有する請求項1に記載の粒子。
- 前記第2のポリマーは前記第1のポリマーの上方に被覆を形成している請求項12に記載の粒子。
- ほぼ球状である請求項1に記載の粒子。
- 孔を有する請求項1に記載の粒子。
- 一定密度の大径孔を有する内部領域と、一定密度の大径孔を有する表面領域とを有し、かつ前記内部領域の大径孔の密度は前記表面領域の大径孔の密度より大きい請求項1に記載の粒子。
- 請求項1に記載の粒子において、前記粒子は重量で約0.1%〜約90%の前記強磁性材料を含有する粒子。
- 請求項1に記載の粒子において、前記ポリマー性基材は無機物、イオン塩を含有する被覆を有する粒子。
- ポリマー性基材と、前記ポリマー性基材中に分配された放射線不透過性材料とを有する粒子において、
前記粒子は約10μm〜約3,000μmの直径を有し、
前記粒子は、一定密度の大径孔を有する内部領域と、一定密度の大径孔を有する表面領域とを有し、かつ前記内部領域の大径孔の密度は前記表面領域の大径孔の密度より大きい粒子。 - 前記放射線不透過性材料は、金属、金属合金、および造影剤からなる群から選択される請求項19に記載の粒子。
- 前記放射線不透過性材料は、二酸化チタンおよび次炭酸ビスマスからなる群から選択される要素を含有する請求項19に記載の粒子。
- 前記放射線不透過性材料は、白金または硫酸バリウムを含有する請求項19に記載の粒子。
- 前記放射線不透過性材料は前記ポリマー性基材中全体にほぼ均一に分配されている請求項19に記載の粒子。
- 前記ポリマー性基材は多糖類を含有する請求項19に記載の粒子。
- 前記ポリマー性基材は、ポリビニルアルコール、ポリアクリル酸、ポリメタクリル酸、ポリビニルスルホン酸、カルボキシメチルセルロース、ヒドロキシエチルセルロース、置換セルロース、ポリアクリルアミド、ポリエチレングリコール、ポリアミド、ポリウレア、ポリウレタン、ポリエステル、ポリエーテル、ポリスチレン、多糖類、ポリ乳酸、ポリエチレン、ポリメタクリル酸メチル、ポリカプロラクトン、ポリグリコール酸、ポリ(乳酸−グリコール酸)共重合体、およびそれらの組合せからなる群から選択される要素を含有する請求項19に記載の粒子。
- 治療剤をさらに含有する請求項19に記載の粒子。
- 前記ポリマー性基材は第1のポリマーと第2のポリマーとを含有する請求項19に記載の粒子。
- 前記第2のポリマーは前記第1のポリマーの上方に被覆を形成している請求項27に記載の粒子。
- ほぼ球状である請求項19に記載の粒子。
- 重量で約0.1%〜約50%の前記放射線不透過性材料を含有する請求項19に記載の粒子。
- ポリマー性基材と、前記ポリマー性基材中に分配された材料とを有し、約10μm〜約3,000μmの直径を有し、一定密度の大径孔を有する内部領域と、一定密度の大径孔
を有する表面領域とを有し、かつ前記内部領域の大径孔の密度は前記表面領域の大径孔の密度より大きく、前記材料は核磁気共鳴映像法によって可視である粒子。 - 前記材料は、常磁性元素を含有する非鉄金属合金と、ジスプロシウムまたはガドリニウムにおける酸化物または炭化物の層で被覆された非鉄金属帯と、超常磁性材料層で被覆された非鉄金属と、遷移金属酸化物のナノ結晶粒子とからなる群から選択される請求項31に記載の粒子。
- 前記材料は、テルビウム−ジスプロシウム、ジスプロシウム、ガドリニウム、Dy2O3、およびGd2O3からなる群から選択される請求項31に記載の粒子。
- 前記材料はガドリニウムを含有する請求項31に記載の粒子。
- 前記ポリマー性基材は多糖類を含有する請求項31に記載の粒子。
- 前記ポリマー性基材は、ポリビニルアルコール、ポリアクリル酸、ポリメタクリル酸、ポリビニルスルホン酸、カルボキシメチルセルロース、ヒドロキシエチルセルロース、置換セルロース、ポリアクリルアミド、ポリエチレングリコール、ポリアミド、ポリウレア、ポリウレタン、ポリエステル、ポリエーテル、ポリスチレン、多糖類、ポリ乳酸、ポリエチレン、ポリメタクリル酸メチル、ポリカプロラクトン、ポリグリコール酸、ポリ(乳酸−グリコール酸)共重合体、およびそれらの組合せからなる群から選択される要素を含有する請求項31に記載の粒子。
- 治療剤をさらに含有する請求項31に記載の粒子。
- ほぼ球状である請求項31に記載の粒子。
- 重量で約5%〜約50%の前記材料を含有する請求項31に記載の粒子。
- 体管腔に配置された複数の粒子を加熱する工程を備える方法において、
前記粒子はポリマー性基材と前記ポリマー性基材中に分配された強磁性材料とを有し、約10μm〜約3,000μmの直径を有する方法。 - 体組織を焼灼する請求項40に記載の方法。
- 前記粒子を加熱する前記工程は、前記粒子をRF放射に曝露する工程を備える請求項40に記載の方法。
- 前記粒子を加熱する前記工程は体組織を加熱する請求項40に記載の方法。
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JP2017517494A (ja) * | 2014-04-17 | 2017-06-29 | ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. | 治療用温熱処置のための機器及び方法 |
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Also Published As
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WO2004020011A1 (en) | 2004-03-11 |
EP1531874A1 (en) | 2005-05-25 |
US20030185895A1 (en) | 2003-10-02 |
US20130079767A1 (en) | 2013-03-28 |
US20090035352A1 (en) | 2009-02-05 |
US9931429B2 (en) | 2018-04-03 |
CA2496612A1 (en) | 2004-03-11 |
US20150182658A1 (en) | 2015-07-02 |
DE60327326D1 (de) | 2009-06-04 |
US7462366B2 (en) | 2008-12-09 |
ZA200502434B (en) | 2005-10-10 |
EP1531874B1 (en) | 2009-04-22 |
US8974829B2 (en) | 2015-03-10 |
AU2003270050A1 (en) | 2004-03-19 |
US7951402B2 (en) | 2011-05-31 |
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