JP7402181B2 - 放射性同位体および他のマーカーを含有するマイクロスフェア、ならびに関連する方法 - Google Patents
放射性同位体および他のマーカーを含有するマイクロスフェア、ならびに関連する方法 Download PDFInfo
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Description
[0001]本出願は、その開示が参照により本明細書に組み込まれる2018年5月18日に出願され、「放射線塞栓送達装置」と題する米国仮特許出願第62/673,632号;および、その開示が参照により本明細書に組み込まれる2018年5月18日に出願され、「ロック機構を有する二段階シリンジ」と題する米国仮特許出願第62/673,628号の優先権の利益を主張する。
[0010]本明細書に記載される実施形態の追加の特性および利点は、以下の詳細な説明に示され、部分的に、その記載から当業者には容易に明らかとなり、または以下の詳細な説明、特許請求の範囲ならびに添付の図面を含む、本明細書に記載される実施形態を実施することによって認識されよう。
[0047]図2の3相マイクロスフェア2を調製する実例の方法は、図4を参照して記載される。3相マイクロスフェア2は、第1の流体を、第1の長軸方向の導管110を通して、第1の長軸方向の導管110の第1の出口開口部112に向かって流すことによって、3トレーマイクロ流体装置200において調製されてもよく、上記第1の出口開口部112は、第1の接触ゾーン115と流体連通にある。同時に、第2の流体は、第1の横軸方向の導管を通して流れ、上記導管は、第1の長軸方向の導管110と第1の接触ゾーン115で交差する。例の実施形態では、第2の流体は、第1の横軸方向の導管120a、120bを通って、対向する方向から第1の接触ゾーン115に向かって流れてもよい。第1の横軸方向の導管120a、120bは、第1の出口開口部112と、第1の横軸方向の導管120a、120bの第2の出口開口部125と、に流体連通している。第2の出口開口部125は、第2の長軸方向の導管130と流体連通にある。第1の流体の流れは、第2の流体の流れに入り、その様式は、第2の長軸方向の導管130に第2の長軸方向の導管130の第3の出口開口部132に向かって流れる2相流を生じさせる様式である。第3の出口開口部132は、第2の接触ゾーン135と流体連通にある。2相流は、第2の流体の連続相によって覆われる第1の流体の液滴40から構成される。
Claims (33)
- 放射線塞栓療法のための多相マイクロスフェアであって、
第1の硬化された樹脂を含む一次相と、
第1の二次相であって、当該第1の二次相は前記一次相によって覆われ、前記第1の二次相は第2の硬化された樹脂を含み、前記第1の二次相は、放射性同位体と、少なくとも1つの放射性元素を含む化合物と、のうち少なくともどちらか一方を含む、第1の二次相と、
を含む多相マイクロスフェア。 - 請求項1に記載の多相マイクロスフェアであって、
前記第1の硬化された樹脂が生体吸収性樹脂または生分解性樹脂である、多相マイクロスフェア。 - 請求項1または2に記載の多相マイクロスフェアであって、
前記第1の硬化された樹脂が水膨潤性ポリマーである、多相マイクロスフェア。 - 請求項1から3のいずれか1項に記載の多相マイクロスフェアであって、
前記第1の硬化された樹脂および前記第2の硬化された樹脂が同一である、多相マイクロスフェア。 - 請求項1から4のいずれか1項に記載の多相マイクロスフェアであって、
前記放射性同位体がベータ放出同位体またはガンマ放出同位体を含む、多相マイクロスフェア。 - 請求項1から5のいずれか1項に記載の多相マイクロスフェアであって、
治療剤をさらに含む、多相マイクロスフェア。 - 請求項1から6のいずれか1項に記載の多相マイクロスフェアであって、
前記一次相、前記二次相、またはそれらの両方が蛍光色素をさらに含む、多相マイクロスフェア。 - 請求項1から7のいずれか1項に記載の多相マイクロスフェアであって、
前記第1の硬化された樹脂がガンマ照射に対して安定である、多相マイクロスフェア。 - 請求項1から8のいずれか1項に記載の多相マイクロスフェアであって、
前記第1の硬化された樹脂が水に対して不透過性である、多相マイクロスフェア。 - 請求項1から9のいずれか1項に記載の多相マイクロスフェアであって、
前記一次相によって覆われる第2の二次相をさらに含み、前記第2の二次相が気体を含む、多相マイクロスフェア。 - 請求項10に記載の多相マイクロスフェアであって、
前記気体が空気である、多相マイクロスフェア。 - 請求項10または11に記載の多相マイクロスフェアであって、
水の中で中性浮力を有する、多相マイクロスフェア。 - 請求項10または11に記載の多相マイクロスフェアであって、
ヒト血液の中で中性浮力を有する、多相マイクロスフェア。 - 2相マイクロスフェアを形成する方法であって、
第1の流体を、第1の長軸方向の導管を通して、前記第1の長軸方向の導管の第1の出口開口部に向かって流すステップであって、前記第1の出口開口部は、第1の接触ゾーンと流体連通にある、ステップと、
第2の流体を、第1の横軸方向の導管を通して流すステップであって、前記第1の横軸方向の導管は、前記第1の長軸方向の導管と前記第1の接触ゾーンで交差し、前記第1の出口開口部と前記第1の横軸方向の導管の第2の出口開口部と流体連通にあり、前記第2の出口開口部は、第2の長軸方向の導管と流体連通にあり、それによって、2相流が、前記第2の長軸方向の導管に入り、前記第2の長軸方向の導管の第3の出口開口部に向かって流れ、前記第3の出口開口部は、第2の接触ゾーンと流体連通にあり、前記2相流は、前記第2の流体の連続相によって覆われる前記第1の流体の液滴を含む、ステップと、
第3の流体を、第2の横軸方向の導管を通して流すステップであって、前記第2の横軸方向の導管は、前記第2の長軸方向の導管と前記第2の接触ゾーンで交差し、前記第3の出口開口部と前記第2の横軸方向の導管の第4の出口開口部とに流体連通しており、前記第4の出口開口部は、第3の長軸方向の導管と流体連通にあり、それによって、3相流が、前記第3の長軸方向の導管に入り、前記第3の長軸方向の導管の第5の出口開口部に向かって流れ、前記3相流は、前記第3の流体を含む連続相によって覆われる2相液滴を含み、前記2相液滴は、前記第2の流体を含む外相によって覆われる前記第1の流体を含む内相を含む、ステップと、
前記2相液滴を、前記第5の出口開口部から硬化用容器に流すステップと、
前記2相液滴を硬化して2相マイクロスフェアを形成するステップと、を含み、
前記第1の流体は未硬化の第1の樹脂を含み、前記第1の流体は、放射性同位体と、中性子照射に際して放射性に作製することができる化合物と、のうち少なくともどちらか一方を含み、
前記第2の流体は、未硬化の第2の樹脂を含み、
前記第3の流体は、前記第2の流体とは不混和性である、方法。 - 請求項14に記載の方法であって、
前記第1の樹脂が生体吸収性樹脂または生分解性樹脂である、方法。 - 請求項14または15に記載の方法であって、
前記第1の樹脂が水膨潤性ポリマーである、方法。 - 請求項14から16のいずれか1項に記載の方法であって、
前記第1の樹脂および前記第2の樹脂が同一である、方法。 - 請求項14から17のいずれか1項に記載の方法であって、
前記放射性同位体がイットリウム-90を含む、方法。 - 請求項14から17のいずれか1項に記載の方法であって、
前記第1の流体が、前記未硬化の第1の樹脂と、中性子照射に際して放射性に作製することができる化合物と、を含み、前記2相マイクロスフェアに中性子照射するステップをさらに含む、方法。 - 請求項19に記載の方法であって、
前記化合物がイットリウム-89を含み、前記中性子照射がイットリウム-89をイットリウム-90に転換する、方法。 - 請求項14から20のいずれか1項に記載の方法であって、
前記第1の流体、前記第2の流体、またはそれらの両方が治療剤をさらに含む、方法。 - 請求項14から21のいずれか1項に記載の方法であって、
前記第1の流体、前記第2の流体、またはそれらの両方が、蛍光色素をさらに含む、方法。 - 3相マイクロスフェアを形成する方法であって、
第1の流体を、第1の長軸方向の導管を通して、第1の長軸方向の導管の第1の出口開口部に向かって流すステップであって、前記第1の出口開口部は、第1の接触ゾーンと流体連通にある、ステップと、
第2の流体を、第1の横軸方向の導管を通して流すステップであって、前記第1の横軸方向の導管は、前記第1の長軸方向の導管と前記第1の接触ゾーンで交差し、前記第1の出口開口部と前記第1の横軸方向の導管の第2の出口開口部とに流体連通しており、前記第2の出口開口部は第2の長軸方向の導管に流体連通しており、それによって、2相流が、前記第2の長軸方向の導管に入り、前記第2の長軸方向の導管の第3の出口開口部に向かって流れ、前記第3の出口開口部は第2の接触ゾーンに流体連通しており、前記2相流は、前記第2の流体の連続相によって覆われる前記第1の流体の液滴を含む、ステップと、
第3の流体を、第2の横軸方向の導管を通して流すステップであって、前記第2の横軸方向の導管は、前記第2の長軸方向の導管と前記第2の接触ゾーンで交差し、前記第3の出口開口部と前記第2の横軸方向の導管の第4の出口開口部とに流体連通しており、前記第4の出口開口部は第3の長軸方向の導管に流体連通しており、それによって、3相流が、前記第3の長軸方向の導管に入り、前記第3の長軸方向の導管の第5の出口開口部に向かって流れ、前記第5の出口開口部は第3の接触ゾーンに流体連通しており、前記3相流は、第3の流体を含む連続相によって覆われる2相液滴を含み、前記2相液滴は、前記第2の流体を含む外相によって覆われる前記第1の流体を含む内相を含む、ステップと、
第4の流体を、第3の横軸方向の導管を通して流すステップであって、前記第3の横軸方向の導管は、前記第3の長軸方向の導管と前記第3の接触ゾーンで交差し、前記第5の出口開口部と前記第3の横軸方向の導管の第6の出口開口部とに流体連通しており、前記第6の出口開口部は第4の長軸方向の導管に流体連通しており、それによって、4相流が、前記第4の長軸方向の導管に入り、前記第4の長軸方向の導管の第7の出口開口部に向かって流れ、前記4相流が、前記第4の流体を含む連続相によって覆われる3相液滴を含み、前記3相液滴が、前記第1の流体を含む第1の内相、前記第2の流体を含む第2の内相、および前記第3の流体を含む外相を含み、前記第1の内相および前記第2の内相が、前記外相によって覆われる、ステップと、
前記3相液滴を、前記第7の出口開口部から硬化用容器に流すステップと、
前記3相液滴を硬化して3相マイクロスフェアを形成するステップと、を含み:
前記第1の流体が、気体または未硬化の第1の樹脂を含み、
前記第2の流体が、未硬化の第2の樹脂を含み、
少なくとも1つの前記第1の流体、前記第2の流体、またはそれらの両方が、放射性同位体、または、中性子照射に際して放射性に作製することができる化合物を含み、
前記第3の流体が、未硬化の第3の樹脂を含み、
前記第4の流体が、前記第3の流体とは不混和性である、方法。 - 請求項23に記載の方法であって、
前記第1の樹脂が、生体吸収性樹脂または生分解性樹脂である、方法。 - 請求項23または24に記載の方法であって、
前記第1の樹脂が、水膨潤性ポリマーである、方法。 - 請求項23から25のいずれか1項に記載の方法であって、
前記第1の未硬化の樹脂および前記第2の未硬化の樹脂が、同一である、方法。 - 請求項23から26のいずれか1項に記載の方法であって、
前記放射性同位体が、ベータ放出同位体またはガンマ放出同位体を含む、方法。 - 請求項23から27のいずれか1項に記載の方法であって、
前記第1の流体が、前記未硬化の第1の樹脂と、中性子照射に際して放射性に作製することができる化合物と、を含み、前記3相マイクロスフェアに中性子照射するステップをさらに含む、方法。 - 請求項28に記載の方法であって、
前記化合物がイットリウム-89を含み、前記中性子照射がイットリウム-89をイットリウム-90に転換する、方法。 - 請求項23から29のいずれか1項に記載の方法であって、
前記第1の流体、前記第2の流体、またはそれらの両方が治療剤をさらに含む、方法。 - 請求項23から30のいずれか1項に記載の方法であって、
前記第1の流体、前記第2の流体、またはそれらの両方が蛍光色素をさらに含む、方法。 - 請求項23から31のいずれか1項に記載の方法であって、
前記第1の流体が気体である、方法。 - 請求項32に記載の方法であって、
前記気体が空気である、方法。
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