JP2020525249A - 血管を処置するための方法および材料 - Google Patents
血管を処置するための方法および材料 Download PDFInfo
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- JP2020525249A JP2020525249A JP2020520196A JP2020520196A JP2020525249A JP 2020525249 A JP2020525249 A JP 2020525249A JP 2020520196 A JP2020520196 A JP 2020520196A JP 2020520196 A JP2020520196 A JP 2020520196A JP 2020525249 A JP2020525249 A JP 2020525249A
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- angioplasty
- vessel
- amniotic
- stenotic
- balloon
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Abstract
Description
本願は、2017年6月22日付出願の米国仮特許出願第62/523,366号の恩典を主張する、2017年9月19日付出願の米国特許出願第15/708,406号の優先権を主張し、これらの全内容は参照により本明細書に組み入れられる。
本書は1つまたは複数の狭窄血管を有する哺乳動物(例えば、ヒト)を処置するための方法および材料に関する。例えば、本明細書において提供される羊膜コーティングバルーンはバルーン血管形成術において用い得る。
血管形成術は心疾患および末梢動脈疾患(PAD)を治療するために用いられることが多い。心疾患は男性および女性の両方で第一の死亡原因であり、PADは少なくとも800〜1200万人のアメリカ人に影響を及ぼし、有病率は年齢とともに増加する(CDC, Heart Disease Facts. cdc.gov/heartdisease/facts.htmからオンラインで入手可能である)。毎年、米国では100万人を超える患者が血管形成術を受けている(American Heart Association. Heart Disease and Stroke Statistics- 2007 Update. Dallas, TX: American Heart Association; 2007(非特許文献1))が、血管形成術を受けた人々の最大で4分の1が血管形成術を再び受けなければならないか、または心疾患の場合では数年以内にバイパス手術を受けなければならない(Harvard Health Publications, "Angioplasty or bypass surgery?" Harvard Heart Letter April 2008(非特許文献2))。
本書は1つまたは複数の狭窄血管を有する哺乳動物(例えば、ヒト)を処置するための方法および材料を提供する。例えば、本明細書において提供される羊膜コーティングバルーン(例えば、羊膜組織調製物でコーティングした血管形成術用バルーン)はバルーン血管形成術において使用できる。一部の場合には、本明細書において提供される羊膜コーティングバルーンを用いて、1つまたは複数の狭窄血管を有する哺乳動物を処置し得る。典型的には、血管の反跳(例えば、再狭窄)を減少させるためにバルーン血管形成術後にステントが血管に挿入される。一部の場合には、本明細書において提供される羊膜コーティングバルーンはステントレスバルーン血管形成術(例えば、ステントを埋め込まないバルーン血管形成術)において使用できる。
本書は、羊膜コーティングバルーン(例えば、羊膜組織調製物でコーティングした血管形成術用バルーン)ならびに羊膜コーティングバルーンを作製しかつ用いるための方法および材料を提供する。例えば、本明細書において提供される羊膜コーティングバルーン(例えば、羊膜組織調製物でコーティングした血管形成術用バルーン)はバルーン血管形成術において用い得る。一部の場合には、本明細書において提供される羊膜コーティングバルーンを用いて、1つまたは複数の狭窄血管を有する哺乳動物(例えば、ヒト)を処置し得る。例えば、羊膜コーティングバルーンをバルーン血管形成術において用いて、1つまたは複数(例えば、2つ、3つ、4つ、またはそれ以上)の狭窄血管を有する哺乳動物を処置し得る。一部の場合には、本明細書において提供される羊膜コーティングバルーンをバルーン血管形成術において用いて、狭窄血管に関連する症状を軽減する、狭窄血管を拡張する、狭窄血管から閉塞を軽減もしくは除去する、および/または狭窄血管における血流を増加させることができる。一部の場合には、羊膜コーティングバルーンを有するバルーンカテーテルを用いて、(例えば、狭窄血管における治癒を促進するために)羊膜組織調製物を狭窄血管に送達し得る。
発明をその詳細な説明と併せて記載したが、先の説明は添付の特許請求の範囲によって規定される発明の範囲を例示することを意図しており限定しないと解釈されたい。他の局面、利点、および変形例は、添付の特許請求の範囲に含まれる。
Claims (30)
- 羊膜組織調製物を含むコーティングを含む血管形成術用バルーン
を含む、血管形成術用バルーンカテーテル。 - 羊膜組織調製物が生細胞を有する、請求項1記載の血管形成術用バルーンカテーテル。
- 羊膜組織調製物が生細胞を欠いている、請求項1記載の血管形成術用バルーンカテーテル。
- 羊膜組織調製物が乾燥羊膜組織調製物である、請求項1〜3のいずれか一項記載の血管形成術用バルーンカテーテル。
- 乾燥羊膜組織調製物が約8パーセント未満の含水率を有する、請求項4記載の血管形成術用バルーンカテーテル。
- 乾燥羊膜組織調製物が約0.1μm〜約25μmの範囲にわたる粒径を有する、請求項4記載の血管形成術用バルーンカテーテル。
- 羊膜組織調製物が唯一の有効成分である、請求項1〜6のいずれか一項記載の血管形成術用バルーンカテーテル。
- バルーンが1つまたは複数の治療剤でさらにコーティングされる、請求項1〜6のいずれか一項記載の血管形成術用バルーンカテーテル。
- ステントレス血管形成術用バルーンカテーテルである、請求項1記載の血管形成術用バルーンカテーテル。
- 以下の工程を含む、哺乳動物における狭窄血管を処置する方法であって、狭窄血管が閉塞血管を含み、狭窄血管に関連する症状が軽減される、方法:
羊膜組織調製物を含むコーティングを含む血管形成術用バルーンを閉塞血管に挿入する工程;および
羊膜コーティングバルーンを膨張させて、閉塞血管において血管形成術を実施する工程。 - 狭窄血管が狭窄末梢動脈であり、症状が、腕および/または脚における、跛行、痙攣、刺痛、疼痛、痺れ、創傷、体温低下、および爪の成長不良からなる群より選択される、請求項10記載の方法。
- 狭窄血管が狭窄冠動脈であり、症状が、脳卒中、心臓発作、胸痛、息切れ、発汗、悪心、めまいまたはもうろう状態、動悸、および不整脈からなる群より選択される、請求項10記載の方法。
- 狭窄血管が狭窄頸動脈であり、症状が、脱力感、錯乱、発話困難、めまい、歩行困難、起立困難、視力障害、麻痺、激しい頭痛、および意識喪失からなる群より選択される、請求項10記載の方法。
- 狭窄血管が狭窄性腎動脈狭窄であり、症状が、腎血流の減少および慢性腎疾患からなる群より選択される、請求項10記載の方法。
- 以下の工程を含む、哺乳動物における狭窄血管を処置する方法であって、狭窄血管が閉塞血管を含み、閉塞血管が拡張される、方法:
羊膜組織調製物を含むコーティングを含む血管形成術用バルーンを閉塞血管に挿入する工程;および
羊膜コーティングバルーンを膨張させて、閉塞血管において血管形成術を実施する工程。 - 閉塞血管が約20%〜約100%開通するように拡張される、請求項15記載の方法。
- 以下の工程を含む、哺乳動物における狭窄血管を処置する方法であって、狭窄血管が閉塞血管を含み、閉塞血管における閉塞が軽減される、方法:
羊膜組織調製物を含むコーティングを含む血管形成術用バルーンを閉塞血管に挿入する工程;および
羊膜コーティングバルーンを膨張させて、閉塞血管において血管形成術を実施する工程。 - 閉塞が約20体積%〜約100体積%軽減される、請求項17記載の方法。
- 以下の工程を含む、哺乳動物における狭窄血管を処置する方法であって、狭窄血管が閉塞血管を含み、閉塞血管における血流が増加する、方法:
羊膜組織調製物を含むコーティングを含む血管形成術用バルーンを閉塞血管に挿入する工程;および
羊膜コーティングバルーンを膨張させて、閉塞血管において血管形成術を実施する工程。 - 血流が約20%〜約100%増加する、請求項19記載の方法。
- 血流が約50cm/sと約250cm/sの間まで増加する、請求項19記載の方法。
- 哺乳動物がヒトである、請求項10〜21のいずれか一項記載の方法。
- 羊膜コーティングバルーンを約5気圧(atm)〜約35atmの圧力まで膨張させる、請求項10〜22のいずれか一項記載の方法。
- 羊膜コーティングバルーンを約10気圧(atm)未満の圧力まで膨張させる、請求項10〜22のいずれか一項記載の方法。
- 血管形成術の反跳は約50%未満である、請求項10〜24のいずれか一項記載の方法。
- 血管形成術用バルーンが腕または鼠径部における経皮的穿刺を通じて挿入される、請求項10〜25のいずれか一項記載の方法。
- 閉塞がアテローム性動脈硬化プラークを含む、請求項10〜26のいずれか一項記載の方法。
- アテローム性動脈硬化プラークが石灰化アテローム性動脈硬化プラークである、請求項27記載の方法。
- 血管形成術の前に閉塞血管においてアテローム切除術を実施する工程をさらに含む、請求項28記載の方法。
- ステントレスバルーン血管形成術である、請求項10〜29のいずれか一項記載の方法。
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