JP2008537695A - 副鼻腔の症状を治療するための装置および方法 - Google Patents
副鼻腔の症状を治療するための装置および方法 Download PDFInfo
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- JP2008537695A JP2008537695A JP2008505446A JP2008505446A JP2008537695A JP 2008537695 A JP2008537695 A JP 2008537695A JP 2008505446 A JP2008505446 A JP 2008505446A JP 2008505446 A JP2008505446 A JP 2008505446A JP 2008537695 A JP2008537695 A JP 2008537695A
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Abstract
Description
本願は、2005年4月4日に出願された、米国仮特許出願第60/668,569号に対する優先権を主張する。米国仮特許出願第60/668,569号は、本明細書中にその全体が参考として援用される。
副鼻腔の症状を治療するための局所薬物送達の分野における装置、システムおよび方法を本明細書に記述する。より特定的には、副鼻腔炎症および鼻副鼻腔炎の治療を記述する。
鼻副鼻腔炎は、副鼻腔炎および/または鼻炎を包含すると一般的に理解される通常の副鼻腔の症状である。基本的に、鼻副鼻腔炎は、鼻汁、鼻閉、顔面うっ血、顔面痛/圧、嗅覚消失および発熱などの主な症状、および頭痛、耳痛/圧、口臭、歯痛、咳および疲労などの軽度の症状により特徴づけられる。
本発明の装置、システムおよび方法は、一般的に副鼻腔の症状を患う患者を治療するために使用される。治療される副鼻腔の症状は、一般的に、副鼻腔炎の機能的内視鏡鼻腔手術(FESS)に起因する術後の副鼻腔炎症であるが、洞または鼻孔に関係がある場合、これに制限されないが、急性副鼻腔炎、慢性副鼻腔炎、アレルギー性鼻炎、鼻副鼻腔炎、FESS後に再発した副鼻腔炎、上気道感染、中耳炎、気管支炎、細気管支炎、喘息、扁桃炎および扁桃および腺様の他の慢性疾患、喉頭炎、気管炎、経鼻および洞ポリープ、大小の気道の腫瘍、上咽頭癌、形質細胞腫、内反性乳頭腫、横紋筋肉腫、扁平上皮癌およびリンパ腫などの経鼻、洞または鼻咽頭腫瘍も含む。本明細書で使用されるように、用語「副鼻腔炎症」または「鼻腔炎症」は、炎症反応に関連する、鼻腔組織、小孔洞組織または小孔洞に近い鼻孔の組織のいかなる反応を意味する。炎症は、アレルギー(過敏症)、例えば、傷害、手術による鼻腔の傷害、バクテリア、ウィルス、真菌、化学物質または薬物による感染、および良性または悪性の腫瘍などのプロセスにより生じる可能性がある。
本発明の副鼻腔装置は、様々な形態を取ってよい。例えば、あるものは、空洞部材、小孔部材および経鼻部を含むように設計され、例えば、洞炎症などの副鼻腔の症状の治療用の活性剤を供給する。空洞部材は、装置が小孔洞または外科的に作られた開窓を通して挿入される第一の収縮配置と、鼻腔内に配置後の第二膨張配置を有する。本変形において、一度膨張すると、空洞部材の構造は、一般的に、収縮配置の体積に対する表面積比と実質的に異ならない体積比に対する表面積を有する。これは、洞粘膜が副鼻腔装置から活性剤を放出するために必要な水源であるため、重要である。従って、洞粘膜に接触することが可能な表面積が、例えば、量に関して、減少すると、活性剤の溶解(そして次に吸収)も減少する。さらに、一度膨張すると、空洞部材も、実質的に鼻腔壁に接触してよい。
他の変形において、小孔部材164は、星状またはアスタリスクのような構造のように構成される、複数のシートまたは細長片のようなフィラメント166から形成されてよい。各細長片間のスペース168は、小孔部材164を通り越し、任意で中央のルーメン165を通して鼻水が流れるのを可能にする。図11Bは、小孔洞内の小孔部材164を示し、図11Cは、小孔部材164の端面図を示す。さらなる変形は図17−19に示す。図17A−17Cを参照にすると、管状小孔部材190(上)は、波状またはプリーツ状のフィルムまたはシート192から形成される。小孔部材190は、大きい直径194の小孔部材を形成するために、矢印の方向に膨張されてよい(図17Cに示す)。図18A−18Cにおいて、管状小孔部材196は、さらなる管により支持される、または支持されない、穴の空いたルーメン199をもつゲル泡状物198から作成される。図19A−19Cの小孔部材200は、個体であるが、複数のルーメン202を備えた多孔シリンダ204である。ルーメン202は、鼻水が端壁206およびシリンダ204の外壁208を通過するように、他の内部空洞および/またはルーメン(示されていない)を通して接続することにより直接的(管のように)または間接的に管状小孔部材200を通して拡張する。
装置の治療効果。副鼻腔装置自体の構造は、治療機能も有する。例えば、本装置は、中鼻甲介の側性成立および中鼻道の閉塞を防止するためのステント留置または充填のように、体構造の開口の補助および維持を提供するためのスペース埋め、固定、偏位を介して、または様々な術後および/または炎症した組織表面間に形成されうる癒着の物理的バリアを提供することにより、組織を固定または支持するようなこのような機能を提供してよい。例えば、個体、半個体(ゲル)または織布または不織布メッシュ構造を組み込んだあらゆる装置が、本方法を施行するのに使用されてよい。他の変形において、本装置は、粘膜毛様体の流れが移動する洞から漏斗、骨−尿道複合構造、鼻道または鼻孔へのチャネル、開窓または口の直接的な提供および維持による本装置の効果を提供することにより、移植特徴領域を通して非閉塞的に開存性を維持する。そのようなチャネルは、普通の洞の構造内に存在し洞を補助する、または洞に外科的に作られたまたは変形された構造内に存在し構造を補助するが、そのような開口を完全に閉塞しない。例えば、管またはカニューレなどのルーメンまたは細孔を備えた装置、またはルーメンを備えたステントは、本方法を施行するために使用されてよく、また、鼻水が流れ、吸収、膨張または分解を通して提供されたチャネルが閉塞しない高多孔質パッキング材料、3次元メッシュまたは表面または内部構造装置も使用されてよい。
押し出されたリボン繊維は、フラン酸モメタゾンおよびポリ(DL−ラクチド−co−グリコシド)を用いて生成された。本装置に含まれる所望するフラン酸モメタゾンは、5重量%のフラン酸モメタゾンであった。ポリ(DL−ラクチド−co−グリコシド)は、70/30DL−ラクチド/グリコシドのモル比でキャップされたエステルで、0.81dL/gの内部粘度をもつ。内部粘度は、クロロホルム中の0.5gm/dLの重合体濃度を用いて、30°Cで測定された。
押し出されたリボン繊維は、フラン酸モメタゾン、クエン酸トリエチル(可塑剤)およびポリ(DL−ラクチド−co−グリコシド)を用いて生成された。本装置に含まれる所望するフラン酸モメタゾンは、5重量%のフラン酸モメタゾンであった。ポリ(DL−ラクチド−co−グリコシド)は、70/30DL−ラクチド/グリコシドのモル比でキャップされたエステルで、0.81dL/gの内部粘度をもつ。内部粘度は、クロロホルム中の0.5gm/dLの重合体濃度を用いて、30°Cで測定された。
繊維調合物は、ポリ(DL−ラクチド)またはポリ(ラクチド−co−グリコシド)を用いてプロピオン酸フルチカゾンで生成されてよい。ポリ(ラクチド)またはポリ(ラクチド−co−グリコシド)は、酸末端基をキャップまたは有してよい。繊維の所望するプロピオン酸フルチカゾン量は、0.1重量%〜20重量%の範囲であってよい。プロピオン酸フルチカゾンの長時間作用性の調合物を調製するために、プロピオン酸フルチカゾンおよびポリ(DL−ラクチド−co−グリコシド)またはポリ(ラクチド−co−グリコシド)の粒子が、乳鉢/乳棒の使用、または混合粉末を形成するためにVブレンダーで、前もって形成された重合体と粒子を混合することを含む、様々な方法で乾燥混合されてよい。次に、混合物または添加物は、2−mmの直径の加工型をもつ二軸押出機に入れられる。押出機の温度は、約120°Cである。繊維が押出機から押し出されると、運搬ベルトに回収される。
実施例1で調製されたリボン繊維は、以下の方法で副鼻腔装置内に製作された。4つのリボン繊維の束が約35mmに切られた後、前述のように泡立て器のような構造を形成するために環状にされた。
実施例4で記述するように調製された副鼻腔は、2.5Mradのガンマ線で殺菌され、鼻背上顎切開により5−kgのウサギの上顎洞(右および左側)に配置された。3つの調合物がテストされた。それらは以下である。
● PLG69:31 5%モメタゾンと0%クエン酸トリエチル(TEC)
● PLG69:31 5%モメタゾンと2%TEC
● PLG69:31 10%モメタゾンと2%TEC
同じ調合物が、当該ウサギの右と左の洞の双方に使用された。15匹のウサギに移植された。5匹のウサギが、各装置の調合物を用いて移植された。装置は、5週間にわたり、移植後、約毎週、外移植された。右と左の双方の粘膜が外移植時に完全に除去された。組織は、即時に凍結され、組織中のモメタゾンの量が液体クロマトグラフィー/質量分光(LC/MS)により定量化された。35日間にわたり組織中に維持されたモメタゾンの量は下の表に報告され、所望する作用の部位で、105M−10−7M濃度に等価であり、全ての時間点において、治療降下をもつことで知られる組織濃度のレベルでの薬剤の徐放性および生物利用性を示す(以下を参照)。
候補成分からのフラン酸モメタゾンのin vitro放出が判断され、図25に示される。このin vitro放出研究を実行するために、各装置は、37°Cで、受入流体であるナノポア水中の1.0重量%の硫酸ナトリウムドデシル(SDS)に配置された。各時間点で、受入流体は、完全に除去され、新しい受入流体が添加された。各時間点で受入に放出されたモメタゾンの量は、HPLCにより定量化された。
Claims (114)
- 副鼻腔の症状を治療する装置であって、空洞部材、経鼻部および一つ以上の徐放性活性剤を備える、装置。
- 前記空洞部材は、前記装置が小孔洞または外科的に作られた開窓を通過可能にする第一の収縮配置と、鼻腔内に設置した後の第二の膨張配置とを有する、請求項1に記載の装置。
- 前記膨張配置における前記空洞部材は、実質的に前記収縮配置の空洞部材から変化しない体積に対する表面積の比を有する、請求項2に記載の装置。
- 前記膨張配置における前記空洞部材は、鼻腔の粘膜表面に実質的に接触する、請求項2に記載の装置。
- 前記一つ以上の活性剤は、前記空洞部材から放出される、請求項1に記載の装置。
- 前記一つ以上の活性剤は、前記経鼻部から放出される、請求項1に記載の装置。
- 前記一つ以上の活性剤は、前記空洞部材および前記経鼻部から放出される、請求項1に記載の装置。
- 小孔部材をさらに備える、、請求項1に記載の装置。
- 前記小孔部材は、前記小孔洞の開存性を維持するように構成される、請求項8に記載の装置。
- 前記小孔部材は、鼻腔内に前記空洞部材を固定するように構成される一つ以上の柔軟なフィラメントを含む、請求項8に記載の装置。
- 前記小孔部材は、鼻腔内に前記空洞部材を固定するように構成されるシートのような材料を含む、請求項8に記載の装置。
- 前記一つ以上の活性剤は、前記小孔部材から放出される、請求項8に記載の装置。
- 前記一つ以上の活性剤は、前記小孔部材および前記空洞部材から放出される、請求項8に記載の装置。
- 前記一つ以上の活性剤は、前記小孔部材および前記経鼻部から放出される、請求項8に記載の装置。
- 前記経鼻部は、鼻腔内に前記空洞部材を固定するように構成される一つ以上の柔軟なフィラメントを含む、請求項1に記載の装置。
- 前記空洞部材は、鼻腔内からの前記空洞部材の変位を阻止するように構成される一つ以上の柔軟なフィラメントを含む、請求項1に記載の装置。
- 前記空洞部材は、前記小孔部を固定するように構成される一つ以上の柔軟なフィラメントを含む、請求項1に記載の装置。
- 前記空洞部材、経鼻部および小孔部材は、生体適合性材料を含む、請求項8に記載の装置。
- 前記空洞部材、経鼻部および小孔部材は、同じ生体適合性材料を含む、請求項18に記載の装置。
- 前記空洞部材、経鼻部および小孔部材は、異なる生体適合性材料を含む、請求項18に記載の装置。
- 前記生体適合性材料は、生体分解性重合体、非生体分解性重合体、金属またはその組み合わせを含む、請求項18に記載の装置。
- 前記生体適合性材料は、生体分解性重合体を含む、請求項21に記載の装置。
- 前記生体分解性重合体は、ポリ(ラクチド)、ポリ(グリコリド)、ポリ(ラクチド−co−グリコリド)、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(乳酸−co−グリコール酸)、ポリ(ラクチド)/ポリ(エチレンングリコール)共重合体、ポリ(グリコリド)/ポリ(エチレングリコール)共重合体、ポリ(ラクチド−co−グリコリド)/ポリ(エチレングリコール)共重合体、ポリ(乳酸)/ポリ(エチレングリコール)共重合体、ポリ(グリコール酸)/ポリ(エチレングリコール)共重合体、ポリ(乳酸−co−グリコール酸)/ポリ(エチレングリコール)共重合体、ポリ(カプロラクトン)、ポリ(カプロラクトン)/ポリ(エチレングリコール)共重合体、ポリ(オルトエステル)、ポリ(ホスファゼン)、ポリ(ヒドロキシブチレート)または、ポリ(ヒドロキシブチレート)を含む共重合体、ポリ(ラクチド−co−カプロラクトン)、ポリカーボネート、ポリエステルアミド、ポリ無水物、ポリ(ジオキサノン)、ポリ(アルキレンアルキレート)、ポリエチレングリコールとポリオルトエステルの共重合体、生体分解性ポリウレタン、ポリ(アミノ酸)、ポリエーテルエステル、ポリアセタール、ポリシアノアクリレート、ポリ(オキシエチレン)/ポリ(オキシプロピレン)共重合体、ならびにそれらの混合または共重合体からなる群から選択される、請求項22に記載の装置。
- 前記生体分解性重合体は、ラクチド/グリコリド重合体を含む、請求項23に記載の装置。
- 前記生体分解性材料は、非生体分解性重合体を含む、請求項18に記載の装置。
- 前記非生体分解性重合体は、ポリ(エチレンビニルアセテート)、ポリ(ビニルアセテート)、シリコン重合体、ポリウレタン、セルロース重合体およびセルロース誘導体などの多糖類、アシル置換セルロースアセテートおよびその誘導体、ポリ(エチレングリコール)とポリ(ブチレンテレフタレート)の共重合体、ポリスチレン、ポリ塩化ビニル、ポリフッ化ビニル、ポリ(ビニルイミダゾール)、クロロスルフォン化ポリオレフィン、ポリエチレンオキシド、ならびにそれらの共重合体および混合からなる群から選択される、請求項25に記載の装置。
- 前記生体分解性材料は、金属を含む、請求項18に記載の装置。
- 前記金属は、コバルト、クロム、ニッケル、プラチナ、ステンレススチール、チタニウム、タンタル、ニッケル−チタニウムおよび合金、ならびにその組み合わせからなる群から選択される、請求項27に記載の装置。
- 前記一つ以上の活性剤は、抗コリン剤、抗ヒスタミン剤、抗感染剤、抗炎症剤、抗瘢痕剤または抗増殖剤、化学療法剤または抗悪性腫瘍薬、サイトカイン、うっ血除去薬、創傷促進剤およびビタミン類、高浸透圧剤、免疫調整物質または免疫抑制剤、ロイコトリエン修飾薬、粘液溶解薬、麻薬沈痛剤、低分子、チロシンキナーゼ阻害剤、ペプチド、タンパク質、核酸、血管収縮剤およびその組み合わせからなる群から選択される、請求項1または8に記載の装置。
- 前記一つ以上の活性剤は、抗炎症剤を含む、請求項29に記載の装置。
- 前記抗炎症剤は、ステロイド系抗炎症剤を含む請求項30に記載の装置。
- 前記ステロイド系抗炎症剤は、21−アセトキシプレグネノロン、アルクロメタゾン、アルゲストン、アムシノニド、ベクロメタゾン、ベタメタゾン、ブデソニド、クロロプレドニゾン、クロベタゾール、クロベタゾン、クロコルトロン、クロプレドノール、コルチコステロン、コルチゾン、コルチバゾール、デフラザコート、デソニド、デスオキシメタゾン、デキサメタゾン、ジフロラゾン、ジフルコルトロン、ジフルプレドナート、エノキソロン、フルアザコート、フルクロロニド、フルメタゾン、フルニソリド、フルオシノロンアセトニド、フルオシノニド、フルオコルチンブチル、フルオトルコロン、フルオロメトロン、酢酸フルペロロン、酢酸フルプレドニデン、フルプレドニゾロン、フルランドレノリド、プロピオン酸フルチカゾン、ホルモコータル、ハルシノニド、プロピオン酸ハロベタソール、ハロメタゾン、酢酸ハロプレドン、ハイドロコルタメート、ハイドロコルチゾン、エタボン酸ロテプレドノール、マジプレドン、メドリゾン、メプレドニゾン、メチルプレドニゾロン、フラン酸モメタゾン、パラメタゾン、プレドニカルベート、プレドニソロン、プレドニソロン25−ジエチルアミノ−酢酸、リン酸プレドニゾロンナトリウム、プレドニソン、プレドニバル、プレドニリデン、リメキソロン、チキソコトール、トリアムシノロン、トリアムニノロンアテトニド、トリアムシノロンベネトニド、トリアムシノロンヘキサアセトニド、ならびにその誘導体および組み合わせからなる群から選択される、請求項31に記載の装置。
- 前記抗炎症剤は、フラン酸モメタゾンを含む、請求項32に記載の装置。
- 前記活性剤は、抗感染剤を含む、請求項29に記載の装置。
- 前記抗感染剤は、抗菌剤、抗真菌剤、駆虫薬、抗ウィルス剤、防腐剤およびその組み合わせからなる群から選択される、請求項34に記載の装置。
- 前記抗感染剤は、抗菌剤を含む、請求項35に記載の装置。
- 前記抗菌剤は、アミノグリコシド、アムフェニコール、アンサマイシン、β−ラクタム、リンコサミド類、マクロライド類、ニトロフラン類、キノロン類、スルホンアミド類、スルホン類、テトラサイクリン類、バンコマイシン、ならびにそれらの任意の誘導体および組み合わせからなる群から選択される、請求項36に記載の装置。
- 前記装置は、一つ以上の活性剤を差次的に放出するように構成される、請求項1に記載の装置。
- 前記活性剤は、前記装置上の被覆に含まれる、請求項1に記載の装置。
- 前記被覆は、重合体をさらに含む、請求項39に記載の装置。
- 前記重合体は、生体分解性重合体を含む、請求項40に記載の装置。
- 約0.01重量%〜約40重量%の一つ以上の活性剤を含む、請求項1または8に記載の装置。
- 約0.01重量%〜約30重量%の一つ以上の活性剤を含む、請求項1または8に記載の装置。
- 約0.01重量%〜約20重量%の一つ以上の活性剤を含む、請求項1または8に記載の装置。
- 約0.01重量%〜約10重量%の一つ以上の活性剤を含む、請求項1または8に記載の装置。
- 約0.01重量%〜約1重量%の一つ以上の活性剤を含む、請求項1または8に記載の装置。
- 前記副鼻腔の症状は、機能的内視鏡鼻腔手術(FESS)に起因する鼻炎、急性副鼻腔炎、慢性副鼻腔炎、アレルギー性鼻炎、副鼻腔炎、FESS後に再発する副鼻腔炎、上気道感染症、中耳炎、気管支炎、細気管支炎、喘息、扁桃炎、ならびに扁桃および腺様の他の慢性疾患、喉頭炎、気管炎、経鼻および洞ポリープ、大小の気道の腫瘍、経鼻、洞および鼻咽頭腫瘍からなる群から選択される、請求項1に記載の装置。
- 前記副鼻腔の症状は、機能的内視鏡鼻腔手術(FESS)に起因する洞炎症である、請求項47に記載の装置。
- 前記副鼻腔の症状が副鼻腔炎である、請求項47に記載の装置。
- 生物膜形成を阻止する物質をさらに含む、請求項1に記載の装置。
- 前記物質は、アルコール、クロロヘキシジン、ヨウ素、トリクロサン、ヘキサクロロフェン、銀ベースの薬剤およびその組み合わせからなる群から選択される、請求項50に記載の装置。
- 前記装置の表面は、生物膜形成を阻止するために、該装置の表面の物理的特性を変更するプロセスにより処理されている、請求項1に記載の装置。
- 副鼻腔の症状を治療する装置であって、
a)近位端部および遠位端部を有する小孔部材と、
b)該小孔部材の遠位端部に接続された空洞部材と、
c)任意で、該小孔部材の近位端部に接続された経鼻部と、
d)徐放性活性剤と
を含み、該空洞部材、該小孔部材および任意の経鼻部は、生体適合性材料を含み、該活性剤は、副鼻腔の症状を治療するために、該空洞部材、該小孔部材、経鼻部またはそのいずれかの組み合わせから放出される、装置。 - 前記生体適合性材料は、生体分解性重合体、非生体分解性重合体、金属またはその組み合わせを含む、請求項53に記載の装置。
- 前記生体適合性材料は、生体分解性重合体を含む、請求項54に記載の装置。
- 前記生体分解性重合体は、ポリ(ラクチド)、ポリ(グリコリド)、ポリ(ラクチド−co−グリコリド)、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(乳酸−co−グリコール酸)、ポリ(カプロラクトン)、ポリ(オルトエステル)、ポリ(ホスファゼン)、ポリ(ヒドロキシブチレート)または、ポリ(ヒドロキシブチレート)を含む共重合体、ポリ(ラクチド−co−カプロラクトン)、ポリカーボネート、ポリエステルアミド、ポリ無水物、ポリ(ジオキサノン)、ポリ(アルキレンアルキレート)、ポリエチレングリコールとポリオルトエステルの共重合体、生体分解性ポリウレタン、ポリ(アミノ酸)、ポリエーテルエステル、ポリアセタール、ポリシアノアクリレート、ポリ(オキシエチレン)/ポリ(オキシプロピレン)共重合体、ならびにそれらの混合または共重合体からなる群から選択される、請求項55に記載の装置。
- 前記生体分解性重合体は、ラクチド/グリコリド重合体を含む、請求項56に記載の装置。
- 前記生体分解性重合体は、非生体分解性重合体を含む、請求項54に記載の装置。
- 前記非生体分解性重合体は、ポリ(エチレンビニルアセテート)、ポリ(ビニルアセテート)シリコン重合体、ポリウレタン、セルロース重合体およびセルロース誘導体などの多糖類、アシル置換セルロースアセテートおよびその誘導体、ポリ(エチレングリコール)およびポリ(ブチレンテレフタレート)の共重合体、ポリスチレン、ポリ塩化ビニル、ポリフッ化ビニル、ポリ(ビニルイミダゾール)、クロロスルフォン化ポリオレフィン、ポリエチレンオキシド、ならびにそれらの共重合体および混合からなる群から選択される、請求項58に記載の装置。
- 前記生体分解性材料は、金属を含む、請求項54に記載の装置。
- 前記金属は、コバルト、クロム、ニッケル、プラチナ、ステンレススチール、チタニウム、タンタル、ニッケル−チタニウムおよび任意の合金またはその組み合わせからなる群から選択される、請求項60に記載の装置。
- 前記活性剤は、抗コリン剤、抗ヒスタミン剤、抗感染剤、抗炎症剤、抗瘢痕剤または抗増殖剤、化学療法剤または抗悪性腫瘍薬、サイトカイン、うっ血除去薬、創傷促進剤およびビタミン類、高浸透圧剤、免疫調整物質または免疫抑制剤、ロイコトリエン修飾薬、粘液溶解薬、麻薬沈痛剤、低分子、チロシンキナーゼ阻害剤、ペプチド、タンパク質、核酸、血管収縮剤およびその組み合わせからなる群から選択される、請求項53に記載の装置。
- 前記活性剤は、抗炎症剤を含む、請求項62に記載の装置。
- 前記抗炎症剤は、ステロイド系抗炎症剤を含む、請求項63に記載の装置。
- 前記ステロイド系抗炎症剤は、21−アセトキシプレグネノロン、アルクロメタゾン、アルゲストン、アムシノニド、ベクロメタゾン、ベタメタゾン、ブデソニド、クロロプレドニゾン、クロベタゾール、クロベタゾン、クロコルトロン、クロプレドノール、コルチコステロン、コルチゾン、コルチバゾール、デフラザコート、デソニド、デスオキシメタゾン、デキサメタゾン、ジフロラゾン、ジフルコルトロン、ジフルプレドナート、エノキソロン、フルアザコート、フルクロロニド、フルメタゾン、フルニソリド、フルオシノロンアセトニド、フルオシノニド、フルオコルチンブチル、フルオトルコロン、フルオロメトロン、酢酸フルペロロン、酢酸フルプレドニデン、フルプレドニゾロン、フルランドレノリド、プロピオン酸フルチカゾン、ホルモコータル、ハルシノニド、プロピオン酸ハロベタソール、ハロメタゾン、酢酸ハロプレドン、ハイドロコルタメート、ハイドロコルチゾン、エタボン酸ロテプレドノール、マジプレドン、メドリゾン、メプレドニゾン、メチルプレドニゾロン、フラン酸モメタゾン、パラメタゾン、プレドニカルベート、プレドニソロン、プレドニソロン25−ジエチルアミノ−酢酸、リン酸プレドニゾロンナトリウム、プレドニソン、プレドニバル、プレドニリデン、リメキソロン、チキソコトール、トリアムシノロン、トリアムニノロンアテトニド、トリアムシノロンベネトニド、トリアムシノロンヘキサアセトニドおよびその誘導体および組み合わせからなる群から選択される、請求項64に記載の装置。
- 前記活性剤は、フラン酸モメタゾンを含む、請求項65に記載の装置。
- 前記空洞部材は、前記装置が小孔洞または外科的に作られた開窓を通過可能にする第一の収縮配置と、鼻腔内に設置した後の第二の膨張配置とを有する、請求項51に記載の装置。
- 前記空洞部材は、少なくとも部分的に鼻腔の形状に一致し、膨張配置で鼻腔の粘膜表面に実質的に接触する、請求項67に記載の装置。
- 前記活性剤は、前記空洞部材から放出される、請求項51に記載の装置。
- 前記空洞部材は、生体分解性重合体、非生体分解性重合体、金属またはその組み合わせからなる、請求項53に記載の装置。
- 前記空洞部材は、生体分解性重合体を含む、請求項70に記載の装置。
- 前記生体分解性重合体は、ラクチド/グリコリド重合体を含む、請求項71に記載の装置。
- 前記空洞部材は、一つ以上の柔軟なフィラメントを含む、請求項53に記載の装置。
- 前記一つ以上の柔軟なフィラメントは、多重ループ構造を形成するように構成されている、請求項73に記載の装置。
- 前記多重ループは、互いに同軸である、請求項74に記載の装置。
- 前記空洞部材は、自己拡張する、請求項53に記載の装置。
- 前記空洞部材は、膨張力の活力により拡張する、請求項53に記載の装置。
- 前記膨張力は、バルーンの膨張により提供される、請求項77に記載の装置。
- 前記空洞部材は、前記装置が洞の外に移動するのを防止するように構成される、請求項53に記載の装置。
- 前記小孔部材は、生体分解性重合体、非生体分解性重合体、金属またはその組み合わせを含む、請求項53に記載の装置。
- 前記小孔部材は、生体分解性重合体を含む、請求項80に記載の装置。
- 前記生体分解性重合体は、ラクチド/グリコリド重合体を含む、請求項81に記載の装置。
- 前記小孔部材は、管構造を形成するように構成されている、請求項53に記載の装置。
- 前記小孔部材は、前記装置が洞の外に移動するのを防止するように構成される、請求項53に記載の装置。
- 前記小孔部材は、小孔洞の開存性を維持するように構成される、請求項53に記載の装置。
- 前記活性剤は、前記経鼻部から放出される、請求項53に記載の装置。
- 前記経鼻部は、生体分解性重合体、非生体分解性重合体、金属またはその組み合わせを含む、請求項53に記載の装置。
- 前記経鼻部は、生体分解性重合体を含む、請求項87に記載の装置。
- 前記経鼻部は、ラクチド/グリコリド重合体を含む、請求項88に記載の装置。
- 前記経鼻部は、複数の放射状かんのように構成される、請求項53に記載の装置。
- 前記経鼻部は、前記装置が洞の外に移動するのを防止するように構成される、請求項53に記載の装置。
- 副鼻腔の症状を治療するシステムであって、
a)ルーメンおよび遠位部を有する導管を備える洞挿入機と、
b)ルーメン内または該洞挿入機の遠位部に脱着可能に固定された副鼻腔装置とを含み、該副鼻腔装置は、空洞部材、小孔部材および任意で経鼻部を含み、ここで、該空洞部材は、該装置が小孔洞または外科的に作られた開窓を通過可能にする第一の収縮配置と、鼻腔内に設置した後の第二の膨張配置とを有する、システム。 - 前記副鼻腔装置は、前記導管ルーメンを通してプッシャーを進行させることにより前記鼻腔内に導入される、請求項92に記載のシステム。
- シースをさらに備える、請求項92に記載のシステム。
- 前記副鼻腔装置は、前記経鼻部および小孔部材を配置し、前記空洞部材を拡張するためにシースを後退させることにより前記鼻腔内に導入される、請求項94に記載のシステム。
- 前記洞挿入機は、前記副鼻腔装置に事前に充填される、請求項92に記載のシステム。
- 前記副鼻腔の症状は、機能的内視鏡鼻腔手術(FESS)に起因する洞炎症である、請求項92に記載のシステム。
- 副鼻腔の症状の治療方法であって、
a)空洞部材、小孔部材、および任意で洞挿入機内または挿入機上に経鼻部を備える副鼻腔装置を提供するステップと、
b)該洞挿入機によって副鼻腔にアクセスするステップと、
c)該空洞部材が拡張後に実質的に副鼻腔の粘膜表面に接触するように、該副鼻腔装置を配置するステップと、
を含む、方法。 - 前記副鼻腔装置は、約1週間、前記副鼻腔の症状を治療するための活性剤を放出する、請求項98に記載の方法。
- 前記副鼻腔装置は、約2週間、前記副鼻腔の症状を治療するための活性剤を放出する、請求項98に記載の方法。
- 前記副鼻腔装置は、約3週間、前記副鼻腔の症状を治療するための活性剤を放出する、請求項98に記載の方法。
- 前記副鼻腔装置は、約1ヶ月、前記副鼻腔の症状を治療するための活性剤を放出する、請求項98に記載の方法。
- 活性剤を供給し、中鼻甲介の側性成立を防止するように構成される、装置。
- 前記装置は、徐放的に活性剤を供給するように構成させる、請求項103に記載の装置。
- 装置は、活性剤を供給し、鼻腔に近い領域または近接領域または切除する鼻腔における組織の付着を防止するように構成される。
- 前記装置は、徐放的に活性剤を送達するように構成される、請求項105に記載の装置。
- 副鼻腔の症状を治療するための装置であって、生体分解性重合体マトリックス内に分散された活性剤を含み、ここで、該装置は、空洞部材、小孔部材および任意で経鼻部を備え、治療的に有効な量の該活性剤が該装置の移植後に、少なくとも約35日間鼻腔組織に維持される、in vivo累積放出プロファイルを示す、装置。
- 治療的に有効な量の前記活性剤は、前記装置の移植後、少なくとも約25日間、前記鼻腔組織に維持される、請求項107に記載の装置。
- 治療的に有効な量の前記活性剤は、前記装置の移植後、少なくとも約14日間、前記鼻腔組織に維持される、請求項107に記載の装置。
- 治療的に有効な量の前記活性剤は、前記装置の移植後、少なくとも約4日間、前記鼻腔組織に維持される、請求項107に記載の装置。
- 移植後、4日以内に鼻腔組織における少なくとも治療的に有効な前記活性剤のレベルを達成する薬物放出運動プロファイルを有する、請求項107に記載の装置。
- 移植後、4日〜35日に、鼻腔組織における少なくとも治療的に有効な前記活性剤のレベルを維持する薬物放出運動プロファイルを有する、請求項107に記載の装置。
- 前記鼻腔からの前記装置の生体分解および物体のクリアランスに実質的に比例し、そして同時であり、該装置のクリアランスまで、該鼻腔の組織の前記活性剤の治療的に有効なレベルを維持する薬物放出運動プロファイルを有する、請求項107に記載の装置。
- 前記活性剤は、請求項111、112、および113に記載の2つ以上のプロファイルを組み合わせた薬物放出運動プロファイルで放出される、請求項107に記載の装置。
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JP2018530521A (ja) * | 2015-08-26 | 2018-10-18 | メドトロニック・ゾーメド・インコーポレーテッド | 鼻甲介の再吸収可能な薬剤溶出性の粘膜下インプラントデバイスおよび方法 |
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