JP5306649B2 - 周囲の流体の流れを邪魔しない埋め込み型装置 - Google Patents
周囲の流体の流れを邪魔しない埋め込み型装置 Download PDFInfo
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- JP5306649B2 JP5306649B2 JP2007524827A JP2007524827A JP5306649B2 JP 5306649 B2 JP5306649 B2 JP 5306649B2 JP 2007524827 A JP2007524827 A JP 2007524827A JP 2007524827 A JP2007524827 A JP 2007524827A JP 5306649 B2 JP5306649 B2 JP 5306649B2
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Description
案されてきたが、幅広く使用される治療技法にはなっていない。
寸法に作られた装置を画定する壁であって、鼻が許容できる微小孔構造の材料から形成される壁と、(b)該壁によって囲まれ、薬物に透過性がある固形担体から構成され、装置が装置からの長期間の連続制御された速度でそれを測定するために十分な量の薬物を含むリザーバと、(c)微小孔の中に充填される拡散による薬物の通過に透過性のある液状媒質とから構成され、(d)装置は、有用な結果を生じさせるために、担体からの液体を通って装置の外部への薬物の通過によって鼻環境内にあるときの薬物を放出する。米国特許第3,948,254号(Zaffaroni)の完全な開示は参照することにより明示的に本書に組み込まれている。
以下の詳細な説明及び添付図面は、必ずしもすべてではないが本発明のいくつかの例または実施形態だけを説明することを目的としている。この詳細な説明及び添付図面は決して本発明の範囲を制限しない。
うな化学物質(例えば、ノノキシノール−9、オクトキシノール−9、塩化ベンザルコニウム、メンフェゴール、及びN−ドコサノール)、標的細胞に対する微生物付着を妨害する、及び/または伝染性の病原体の進入を阻止する化学物質(例えば、PC−515(カラギーナン)、プロ−2000、及びデキストリン2サルフェート等の硫酸化ポリマーとsulponatedポリマー)、レトロウィルスが細胞内で複製するのを妨げる抗レトロウィルス剤(例えばPMPAゲル)、「抗体」として知られている植物から遺伝子操作された抗ウィルス抗体等の病原体と戦う遺伝子操作された、あるいは自然発生的な抗生物質、(粘膜pHを改変する物質(バッファゲル(Buffer Gel)及びアシッドフォーム(Acidform)等の)組織の状態を変化させ、それを病原体に対して敵対させる薬剤、過酸化水素または病原微生物(乳酸菌)を殺す、またはその成長を阻止する他の物質の生成を引き起こす非病原性、つまり「扱いやすい」微生物、参照することにより本書に明示的に組み込まれている米国特許番号第6,716,813号(リンら)に説明されているもののような抗微生物蛋白質またはペプチド、または抗菌性金属(例えば、コロイダルシルバー)を含む。
als,Inc.)またはカリフォルニア、サウスサンフランシスコ(South San Francisco, California)により製造される「R−112」という名前の薬剤等のSYK キナーゼ抑制剤を含んでよい。
加えてまたは代わりに、ヒスタミン放出を妨げるまたは阻止することが所望される応用例のようないくつかの応用例では、本発明で送達される物質は多様なマスト細胞安定剤またはクロモリン(例えば、Nasal ChromR)及びネドクロミルのようなヒスタミンの放出を妨げる薬物を含んでよい。
の浸透含有量を直接的にまたは間接的に変更する、組織または物質から水を引き抜く他の塩製剤等の高浸透性薬剤を含んでよい。
ucogenesisまたはciliagenesis等に関与するまたは達成する細胞を含んでよい。
剖学的壁(複数の場合がある)に接触する別々の領域、及び該隣接する解剖学的壁(複数の場合がある)に接触しない他の領域を有してよい、及び/またはそれらは内部中空内腔を取り込んでよい。本発明のいくつかの実施形態は中央内腔を含むが、大部分の場合、粘液が重力または真の圧力を介して埋め込まれた装置の内腔を通って流れることは不可能あるいは非現実的である場合がある。したがって、この中央内腔は、このような場合には流体はさらに容易に装置の回りに伝達される可能性があるため、解剖学的通路の開通性を維持するために有効な構造ではない可能性がある。その結果、本書に説明される本発明の他の実施形態では、装置は粘液がその間を流れることを可能にする離間された支柱または部材を備えてよく、このようにして粘液が装置の中の内腔または穴に進入する必要性を回避する。また、支柱が相対的に薄く、装置が、繊毛が装置の内側内腔にじかに接することができるように開放細胞構造から構成される本発明の他の実施形態もある。これらの状況では、粘液の除去は、圧力または重力に依存しなくても中央内腔を通して可能である可能性がある。
容できてよい。物質のこのような包装済み混合物または組み合わせは装置の中への直接的な装入に適した液状形式であってよい、あるいは指定量の液体(例えば、滅菌水、0.9%のNaCl溶液等)で容易に戻すことができる乾燥形式(例えば凍結乾燥済み、または粉末)であってよい。代わりに、装置は同時にまたは連続して薬物(複数の場合がある)を放出する2つ以上の分離されたチャンバを含んでよい。代わりに、他の一実施形態は、添加剤と混合されることなく装置の中で事前に結び付けられるまたは事前に装入される1つまたは複数の薬物または物質を含んでよい、あるいは使用時、他の添加剤を付加される、又は、混合される1つ又は複数の薬物又は物質を含んでよい。
ヤと互換性のあるさらに小さいカテーテルの使用を可能にする。
Other Disorders of the Ears,Nose and/or
Throat)」と題される特許出願、出願番号第10/829,917号に詳細に説明されている。カテーテル16は、口装置14を通して、及び鼻腔を通して左前頭洞への小孔の中の場所、または小孔に非常に近い場所に進められる。カテーテル16の挿入の前または後に、埋め込み型物質送達装置12は送達カテーテル16の内腔の中に装入され、引き伸ばした部材18は埋め込み型物質送達装置12に近位で送達カテーテル16の内腔の中に配置される。別個のガイドカテーテル(不図示)が口装置14を通して左前頭洞の小孔近くの一まで進められ、そのご送達カテーテルがそのガイドカテーテルを通って、送達カテーテルの末端が左前頭洞の小孔の中にあるいは小孔にすぐ隣接する位置に進められてよい場合もあることが理解されるであろう。その後、引き伸ばした部材18は末端方向で勧められ、それにより埋め込み型物質送達装置12を送達カテーテル16の末端から押し出してよい。代わりに引き伸ばした部材18の末端は、送達カテーテル16の内腔の中の薬物送達装置12の近端と接触して配置され、その後引き伸ばした部材18は、埋め込み型物質送達装置12を送達カテーテル16の末端の中から通過させるために、送達カテーテル16が近端方向で引っ込められる間に静止して保持されてよい。いずれにせよ、物
質送達装置は前頭洞の中に完全にまたは部分的に配置され、その後、口装置14、送達カテーテル16、及び引き伸ばした部材18は取り外されてよい。埋め込み型物質送達装置12は多様な方法で構築されてよく、その例は図2から図12Fに示され、後述される。本発明の実施形態のどれかにおいて、所望される診断物質または治療剤は、装置12が体内に埋め込まれる前及び/または後に埋め込み型物質送達装置12の中に装入されてよい。
御する材料から構築されてよい。また、外側障壁26は、物質が多孔母材24から外側障壁26を通って、装置12の中から通過する速度を制御する材料(例えば、半透膜)から構築されてよい。複数の薬物を含むために装置の中で複数のチャンバを活用する物質送達装置の他の実施形態があってよい。これらのチャンバは、各チャンバのストリップが装置の全長を移動するが、断面が複数のコンパートメントを示すように軸方向に配列されること、装置の末端部分が真中部分または近端部分とは異なる薬物を含むことができるように長手方向に配列されること、または送達される第1の薬物が多様な苦痛を治療するために、その時々において次の薬物とは異なること、即ち、最初は炎症に対処するため、次に所定の期間後、感染と戦うために抗菌剤の放出を開始することが可能であるように(玉ねぎのような)層で配列されることを含むが、これらに限定されない多様な構成で配置できるであろう。層状構成では、分割する膜は生分解性であってよい、あるいは生分解性でなくてよい。本発明の装置12は、当初、装置12の中に診断物質または治療剤を入れずに提供されてよい。このような場合には、医師は、次に、装置が被験者の体内に埋め込まれる前に特定の治療剤または診断物質あるいはこのような物質の組み合わせを選択する、あるいは装置12の中に調製してよい。他の応用例では、医師は、装置が被験者の体内に埋め込まれた後に所望される治療剤または診断物質あるいはこのような物質の組み合わせ柄を装置12の中に装入してよい。装置12に装入される診断物質または治療剤(複数の場合がある)の医師の選択または調製を容易にするために、装置12は、装置12に装入された物質(複数の場合がある)の所望される投薬量(複数の場合がある)が埋め込まれた装置12によって送達されるように、物質(複数の場合がある)の希釈と装置12の装入を容易にするためのデータ編集によって達成されてよい。このようなデータ編集は表形式データ、アルゴリズム(複数の場合がある)等の形式であってよい。また、このようなデータ編集は、ハードコピー(例えば添付文書または小冊子)として文書形式(例えば、表またはリストとして)で提供されてよい、あるいは(例えば、コンパクトディスク上に、ウェブサイトからアクセスできる、特に本発明の装置12とともに使用するためにプログラミングされるハンドヘルド電子投薬量計算機等のコンピュータまたはマイクロプロセッサ装置の中にプログラミングされる等)電子形式で記憶されてよい。装置12によって送達される特定の物質(複数の場合がある)の投薬量は、特定の定められた重要な特性を有する特定の物質、製剤、混合物、または溶質または物質の濃縮物が装置12の障壁26を通過する決定された速度(複数の場合がある)となるであろう。データ編集は、特定の障壁遷移速度が提供される特定の重要な特性の例またはリストを含む、または攻勢しても良い粘度または粘度の範囲、分子量または分子量の範囲、オスモル濃度またはオスモル濃度の範囲、電気量、オスモル濃度またはオスモル濃度の範囲、特定の化学基または原子の存在、親水性または疎水性等を含むが、これらに限定されない。特定のステロイドまたはステロイド/抗菌性の製剤を用いる本発明の装置12の準備及び装入を容易にするために提供されてよい1つのタイプのデータ編集の例は、以下の表1に示されるような図表である。
この表に説明されているすべてのパーセンテージは、重量パーセントとして表されている。この表が、その装入及び異なる物質及び/または異なる濃度の物質との使用を容易にするために、本発明の特定の埋め込み型物質送達装置12に付随してよい物質放出速度に関する操作情報またはデータが1つの方法を示すために提供される例示的な例にすぎないことが理解されるべきである。使用される実際の物質及びそれらの物質の実際の送達速度は、装置12の使用目的、装置12の中に装入される物質の重要な特性、及び装置12の多孔母材24及び/または外側障壁26の相対多孔率または浸透性に依存する。前述された表は、それによって医師が、製剤に含有される、異なる局所投与量の薬剤を送達する、異なる希釈剤(例えば、真中の欄に一覧表示された濃度X、Y、またはZ)を調製するために1つまたは複数の薬物を含む開始製剤(例えば、左の欄に一覧表示された製剤)を使用してよいいくつかの例を示している。開始製剤(例えば、左欄に一覧表示された製剤)は、鼻腔内の投与または体内のどこかの粘膜組織への局所投与のために承認される、及び/または使用できる市販されている医薬品を備えてよい。開始製剤(例えば、左欄に一覧表示された製剤)は、本書に説明されるように、a)包装されてよい、及び/または本発明の装置12とともに提供されてよい、b)本発明の装置12とは別個に医師によって入手されてよい、及び/またはc)本発明の装置12の中で濃縮された(例えば、乾燥したまたは凍結乾燥された形式)で事前に装入されてよい。いくつかの場合では、装置12は、装置の中に(例えば、管20の内腔22の中に、及び/または多孔母材24の中に)含まれる乾燥した(例えば、凍結乾燥されたまたは粉末化された)診断物質または治療剤(例えば、薬物製剤)を備えてよく、医師は後に、物質をもどすまたは溶解するため、及び装置12を拡張する、または活性化するために、測定された量の溶媒(例えば、無菌水、0.9%のNaCl溶液、基本食塩水等)を注入してよい。このような場合には、装置1
2と提供される指示または他の情報は、さまざまな量の溶媒を注入することにより生じる物質の異なる濃度についての情報を含んでよい。他の場合には、装置は拡大状態で提供されてよく、送達のために圧縮される、または整形し直され、その後所望される埋め込み場所に応じて完全に、わずかに拡大し直される必要がある、またはまったく拡大し直される必要はない。前述されたように、いくつかの場合では、開始製剤(例えば、左欄に一覧表示された製剤)は市販されている製剤であってよい。例えば、表1の最初の1、2及び7で言及されたプロピオン酸フルチカゾンは、FlonaseR鼻スプレー(グラクソスミスクライン(Glaxo SmithKline)、リサーチトライアングルパーク(Research Triangle Park)、ノースカロライナ(North Carolina))として鼻腔内スプレー投与のための製剤として市販されている。FlonaseR鼻スプレーの有効成分であるプロピオン酸フルチカゾンは、化学名S−(フルオロメチル)6(,9−ジフルオロ−11R−17−ジヒドロキシ−16−(−メチル−3−オキソアンドロスタ−1,4−ジエン−17R−carbothioate、17−プロピオン酸を有する合成副腎皮質ステロイドである。それは、微晶性セルロース及びカルボキシメチルセルロースナトリウム、デキストロース0.02%、w/w塩化ベンザルコニウム、ポリソルベート80、及び0.25%のw/wフェニルエチルアルコールを含有し、5から7の間のpHを有する、超微粒プロピオン酸フルチカゾンの水性懸濁液として提供される。この市販されているFlonase製品は、いくつかの場合では、装置12が、後で被験者の体内に埋め込まれたときに、所望される投薬量のプロピオン酸フルチカゾンを、単独であるいは他の薬剤(複数の場合がある)(表1の右欄)と組み合わされて送達するように、装置12に装入される前に、1つまたは複数の他の物質と結合される、及び/または多様な希釈物(例えば、表1の真中の欄)で調製されてよい基本製剤(表1の左欄)としての機能を果たしてよい。物質が懸濁液の形を取るこのような例では、懸濁液はそれが埋め込まれた装置12の中で安定したままとなるように調製されてよく、装置12の障壁26は、懸濁液の粒子(例えば、微小粒子)が所望される速度で障壁を通過できるようにするほど十分に大きい孔隙を備えてよい。
ら乳白色の無償の結晶性粉末である。LotrisoneRローションの1グラムは、純水の親水性基剤、鉱物油、白色ワセリン、ステリアルアルコールが加えられたセチルアルコール、セテアレス−30、プロピレングリコール、リン酸ナトリウム第1一水和物、及びリン酸、保存料としてのベンジルアルコールの中で、10mgのクロトリマゾールと0.643mgのジプロピオン酸ベタメタゾン(0.5mgのベタメタゾンに同等)を含有する。本発明の装置12が鼻、副鼻腔、または耳、鼻または咽喉の中の他の場所に埋め込まれなければならない応用例の場合、基本製剤(表1の左欄)は、LotrisoneRローションの低粘度形式を備え、ローションベースがない限り(例えば、鉱物油、白色ワセリン、ステアリルアルコールが加えられたセチルアルコール、セテアレスー30及び/またはプロピレングリコールの内のいくつかまたはすべてを除いた)、LotrisoneRローションの活性成分を含む微小粒子の溶液または懸濁液を備えてよい。
られずに)医師に提供されてよい。医師は、次に、装置12a、12bが体内に埋め込まれる前、または後に、装置12a、12bの中に装入される1つまたは複数の診断物質または治療剤を選択するまたは調合してよい。
それ以外の場合図8Aから図8Eの例に図示され、後述されるように操作するまたは密封する等)があってよい。
たは生物分解を開始した後に、装置全体または装置の部分(複数の場合がある)を移動するまたは取り外すのを容易にするために装置の外面上の多数の位置に配置されてよい。
充填管及びキャップ装置62、64の代わりに、多様な他の充填サイト/閉鎖装置または設計が使用されてよいことが理解されるであろう。装置12gの小孔内部分58はその中に形成される環状の溝を有する。図7A及び図7Bから理解できるように、この環状の溝は小孔OSの環を受け入れ、下にある骨Bと摩擦により係合するように構成され、それにより装置12gを意図された埋め込み位置に配置する、または据えつける及び/または保持するのに役立つ。当初、装置12gは、装置は、図7及び図7Aに示されるように、小孔OSを通って、副鼻腔の中に進められるほど十分に小さい直径詰まり最大断面寸法D1を有する折り畳まれた形状にある。以後、注射器及び針66が、装置12gの中に所望される診断物質または治療剤68を含有する公知の量の溶液を注入するために使用される。装置12gの中に溶液を含有する物質を装入すると、副鼻洞内の部分56が、大きすぎて小孔OSを通過できないさらに大きな直径D2まで膨れ、それにより図7Bに示されるように、副鼻洞内部分56を副鼻腔の中に保持する傾向がある。
図8Cは、充填管と、物質が充填管70の中から逆流するのを妨げるために充填管70を結さつするために使用できる1本の縫合材料または引き抜きひも等の結さつ糸76を有する装置を示す。要すれば結さつ糸76を受け入れ、結さつ糸76の長手方向の滑りを妨げるために、環状の凹みつまり溝が充填管の中に形成されてよい。
8と係合する係合部材102を有する。送達カテーテル100の近端は、調節つまみ104を有するハンドピースを備える。調節つまみ104が引っ込められると、係合部材102が突起96、98を離し、それによって装置12hを解放し、図9Bに示されるように送達カテーテル100を引っ込め、取り除くことができるようにする。付着部分98がネジを備えるケースでは、装置12hが送達カテーテル100から解放される前に、送達カテーテル100は、カテーテルが隣接する軟組織または骨の中にネジをねじ込むために回転できるように編まれる、あるいはそれ以外の場合技術で周知の技法に従って構築されてよい。前述された他の実施形態においてのように、物質は、装置12hが被験者の体内に埋め込まれる前または後にこの装置12hの中に装入されてよい。
前述された実施形態は、外科開放処置、腹腔鏡外科処置または介入処置の後にスペーシング装置として使用されてよい。さらに、これらの装置は反射防止剤で表面を覆われる、あるいは毒素性ショック症候群または他の装置に関連した感染の尤度を削減するために自然に静菌性である。このような自然に静菌性の物質は、微生物分解の過程を通して加水分解を経て、過酸化水素等の静菌性の物質を放出する生分解性物質であろう。
Claims (63)
- 疾患を診断または治療するための被験者または被験動物の副鼻腔または副鼻腔の小孔内の場所に物質を送達するための装置において、
折り畳まれた形状にあり、前記物質を含まない間に前記場所に進めることができ、後で前記物質を装入し得るリザーバであって、これにより、前記リザーバが、前記場所にあるときに、展開形状を取るようになっており、前記リザーバは、障壁であって、当該障壁を通って前記リザーバ中に導入された物質が、公知の速度で前記リザーバから排出される障壁を備える、リザーバと、
前記リザーバから延在し、内腔を有する充填管であって、前記リザーバが前記場所に進められた後、当該充填管の内部を通じて前記物質を前記リザーバの中に装入可能である充填管と、
前記物質が前記リザーバ中に導入された後、前記充填管からの前記物質の逆流を防止するための、弁、クリップ、クランプ、結さつ糸または接着剤から選択された閉鎖装置と、を備え、
前記装置は、前記装置が前記場所に埋め込まれ、物質を装入するときに、前記装置が、前記副鼻腔または副鼻腔の小孔からの液の排出の邪魔をしないように構成されている、
装置。 - 請求項1に記載の装置において、前記リザーバが中空の空洞を備える、装置。
- 請求項2に記載の装置において、前記中空の空洞が管を含む、装置。
- 請求項1に記載の装置において、前記リザーバが、ある量の前記物質を保持するための多孔材料を含む、装置。
- 請求項4に記載の装置において、前記多孔材料がスポンジを含む、装置。
- 請求項4に記載の装置において、前記多孔材料が、
可撓性高分子発泡体と、
生分解性高分子発泡体と、
非生分解性高分子発泡体と、
多孔PLLAと、
多孔PLGAと、
多孔ヒドロゲルと、
ポリビニルアルコールと、
シリコーン発泡体と、
ポリテトラフルオロエチレンと、
拡張ポリテトラフルオロエチレンと、
ラテックスと、
ナイロンとからなる多孔材料のグループから選択される物質である、装置。 - 請求項1に記載の装置において、前記リザーバが、ある量の前記物質を保持するための多孔材料と組み合わされて中空の空洞を備える、装置。
- 請求項4に記載の装置において、前記多孔材料は、前期物質が前記中空の空洞の中に導入された後で、前記多孔材料の中に吸収または輸送され得るように、中空の空洞に隣接して設けられる、装置。
- 請求項1に記載の装置において、前記充填管は、前記物質が前記リザーバの中に導入された後に閉じるために適切な構造を有する、装置。
- 請求項1に記載の装置において、前記充填管が出入り口を供える、装置。
- 請求項1に記載の装置において、前記充填管は、前記物質が前記リザーバの中に導入されるための管を備える、装置。
- 請求項11に記載の装置において、前記導入管の少なくとも一部は、前記物質が前記リザーバの中に導入された後に取り外し可能である、装置。
- 請求項11に記載の装置において、前記物質が前記リザーバの中に導入された後に、前記導入管を、クランプで締め付け、クリップで留め、結さつし、結び、または圧縮するための装置をさらに備える、装置。
- 請求項1に記載の装置において、前記閉鎖装置が自動密封針出入り口を備える、装置。
- 請求項1に記載の装置において、前記閉鎖装置が弁を備える、装置。
- 請求項15に記載の装置において、前記弁は、流体を注入する間には前記リザーバの中に第1の方向で前記液体を注入できるようにするが、注入の後には、前記流体が前記リザーバの中から第2の方向で流出することを防止するための逆止め弁を備える、装置。
- 請求項1に記載の装置において、前記閉鎖装置が自動密封材料を備え、前記自動密封材料には針を挿入することが可能であるとともに、前記針が取り除かれた後に前記針によって作られる貫通通路を密封する、装置。
- 請求項1に記載の装置において、前記障壁が、特定の特性を有する物質が公知の速度で前記障壁を通って前記リザーバから排出できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、特定の粘度または粘度範囲の物質が前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、特定の分子量の、あるいは分子量の特定の範囲内の物質が、前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、特定の電気量を有する物質が前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、ある特定のオスモル濃度または特定のオスモル濃度範囲の物質が前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、ある特定のオスモル濃度または特定のオスモル濃度範囲の物質が前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、ある特定の化学基または原子を含む物質が前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項18に記載の装置において、前記障壁が、特定の親水性または疎水性を有する物質が前記公知の速度で前記障壁を通過できるように構築される、装置。
- 請求項1に記載の装置において、前記障壁が半透性の障壁を備える、装置。
- 請求項26に記載の装置において、前記半透性の障壁が公知のサイズの孔を有する、装置。
- 請求項27に記載の装置において、前記物質が、公知の速度で前記孔を通過する物質である、装置。
- 請求項1に記載の装置を備えるシステムにおいて、公知の速度で前記障壁を通過する物質を含有する薬学的に許容できる製剤と組み合わせた、システム。
- 請求項29に記載のシステムにおいて、特定の物質、溶液、懸濁液、またはその多様な希釈物を、前記物質、溶液、懸濁液、またはその多様な希釈物が前記障壁を通過する特定の速度に関連付けるデータ編集、アルゴリズム、または数式をさらに備える、システム。
- 請求項30に記載のシステムにおいて、前記データ編集、アルゴリズムまたは数式が表を備える、システム。
- 請求項30に記載のシステムにおいて、前記データ編集、アルゴリズムまたは数式がデータベースを備える、システム。
- 請求項30に記載のシステムにおいて、前記データ編集、アルゴリズム、または数式が文書形式で提供される、システム。
- 請求項30に記載のシステムにおいて、前記データ編集、アルゴリズムまたは数式が電子的に読み取り可能な形式で提供される、システム。
- 請求項30に記載のシステムにおいて、前記データ編集、アルゴリズムまたは数式がコンピュータディスクを備える、システム。
- 請求項30に記載のシステムにおいて、前記データ編集、アルゴリズム、または数式が、ユーザによるデータ入力を受信するように、及び特定の物質、溶液、懸濁液、またはその多様な希釈物に関連する前記データ、情報に応えて、前記物質、溶液、懸濁液、またはその多様な希釈物を前記障壁を通過する特定の速度で提供するようにプログラミングされる電子計算機または他の電子デバイスの形式で提供される、請求項35に記載のシステム。
- 請求項36に記載のシステムにおいて、前記ユーザが該埋め込み型物質送達装置によって送達されるべき1つまたは複数の薬物または他の物質を特定する情報を入力し、前記電子計算機または電子デバイスが、
前記埋め込み型物質送達装置に装入するための前記薬物または他の物質を調製する際に
使用される希釈剤または溶媒と、
前記薬物または他の物質により治療され得る感染性微生物、病気、疾患及び状態に関する情報と、
薬物または物質相互作用警告と、
前記選択される薬物または他の物質の考えられる副作用に関する警告と、
前記選択される薬物または他の物質が、1つまたは複数の濃度で該埋め込み型物質送達装置に装入されるときに前記障壁を通過する該公知の速度と、
から選択される情報を提供する、システム。 - 請求項29に記載のシステムにおいて、前記薬学的に許容できる製剤が、
画像形成可能な造影剤と、
診断インジケータ剤と、
抗生物質と、
抗真菌剤と、
駆虫薬と、
抗菌剤と、
ステロイドと、
血管収縮薬と、
ロイコトリエン抑制剤と、
IgE抑制剤と、
抗炎症薬と、
肥満細胞安定化薬と、
抗ヒスタミン剤と、
免疫賦活剤と、
SYKキナーゼ抑制剤と、
化学療法薬と、
抗腫瘍薬と、
粘液溶解薬と、
粘液の粘度を薄めるまたはそれ以外の場合変更する薬剤と、
軟組織及び/または骨及び/または軟骨の再形成を容易にする物質と、
からなるグループから選択される少なくとも1つの物質を含有する、システム。 - 請求項29に記載のシステムにおいて、前記薬学的に許容できる製剤が、ベクロメタゾン、フルニソリド、フルチカゾン、トリアムシノロン、モメタゾン、アクロメタゾン、デソニド、ヒドロコルチゾン、ベタメタゾン、クロコルトロン、デソキシメタゾン、フルオシノロン、フルランドレノリド、モメタゾン、プレドニカルベート、アムシノニド、デソキシメタゾン、ジフロラゾン、フルオシノロン、フルオシノニド、ハルシノニド、クロベタゾール、拡張ベタメタゾン、ジフロラゾン、ハロベタソール、プレドニゾン、デキサメタゾン、及びメチルフレドニゾロンからなるグループから選択されるステロイドである少なくとも1つの物質を含有する、システム。
- 請求項29に記載のシステムにおいて、前記薬学的に許容できる製剤が、アシクロビル、アマンタジン、アミノグリコシド抗生物質、アミカシン、ゲンタマイシン、トブラマイシン、アモキシシリン、アモキシシリンクラブラン酸、アムホテリシンB、アンピシリン、アンピシリンスルバクタム、アトバクオン、アジスロマイシン、セファゾリン、セフェピム、セフォタキシム、セフォテタン、セフポドキシム、セフタジジム、セフチゾキシム、セフトリアキソン、セフロキシム、セフロキシムアクセチル、セファレキシン、クロラムフェニコール、クロトリマゾール、シプロフロキサシン、クラリスロマイシン、クリンダマイシン、ダプソン、ジクロキサシリン、ドキシサイクリン、エリスロマイシン、フルコナゾール、フォスカーネット、ガンシクロビル、アティフロキサシン、イミペネム/シラスタチン、イソニアジド、イトラコナゾール、ケトコナゾール、メトロニダゾール、ナフシリン、ナフシリン、ナイスタチン、ペニシリン、ペニシリンG、ペンタミジン、ピペラシリン/タゾバフタム、リファンピン、キヌプリスチン−ダルフォプリスチン、チカルシリン/クラブラン酸、トリメトプリム/スルファメトキサゾール、バラシクロビル、バンコマイシン、マフェニイド、スルファジアジン銀、ムピロシン、ナイスタチン、トリアムシノロン/ナイスタチン、クロトリマゾール/ベタメタゾン、クロトリマゾール、ケトコナゾール、ブトコナゾール、ミコナゾール、チオコナゾール、微生物を崩壊させるまたは無能にする合成洗剤のような化学物質、ノノキシノール−9、オクトキシノール−9、塩化ベンザルコニウム、メンフェゴール、及びN−ドコサノール、標的細胞に対する微生物付着を妨害する化学物質、伝染性の病原体の細胞への進入を阻止する化学物質、硫酸化ポリマー、sulponatedポリマー、カラギーナン、抗レトロウィルス剤、PMPAゲル、抗生物質、病原体と戦う遺伝子操作された、あるいは自然発生的な抗生物質、抗体、組織の状態を変化させ、それを病原体に対して敵対させる薬剤、粘膜pHを改変する薬剤、バッファゲル、病原菌を殺す、あるいは病原菌の成長を阻止する酸性型及び非病原性微生物からなるグループから選択される抗菌剤を含有する、システム。
- 請求項29に記載のシステムにおいて、前記充填管を通って、前記リザーバの中に前記薬学的に許容できる製剤を導入するために使用できる少なくとも1つの物質導入装置をさらに備える、システム。
- 請求項41に記載のシステムにおいて、前記物質導入装置が注射器を備える、システム。
- 請求項41に記載のシステムにおいて、前記物質導入装置が、所定量の前記薬学的に許容できる製剤がいつ該物質導入装置の中に入れられるのかを示すインジケータを含む、システム。
- 請求項43に記載のシステムにおいて、前記所定量が、前記リザーバを実質的に一杯にする量である、システム。
- 請求項29に記載のシステムにおいて、前記装置が、前記物質導入装置の中に事前に装入された、測定された量の前記薬学的に許容できる製剤を備える、システム。
- 請求項41に記載のシステムにおいて、物質の前記リザーバの中への、反復される装入のための複数の物質導入装置を備える、システム。
- 請求項1に記載の装置において、前記装置が少なくとも部分的に生分解性である、装置。
- 請求項1に記載の装置において、前記装置が少なくとも部分的に生分解性ではない、装置。
- 請求項1に記載の装置において、前記装置の把持及び除去を容易にするために前記装置から伸びる把持可能部材をさらに備える、装置。
- 請求項1に記載の装置において、さらにフレームを備える、装置。
- 請求項50に記載の装置において、前記フレームが埋め込み後に所望される形状に前記装置を維持するように構築される、装置。
- 請求項1に記載の装置において、前記物質を前記リザーバに導入すると、前記装置がその折り畳まれた形状からその展開形状に移行する、装置。
- 請求項1に記載の装置において、前記装置が概ね円形の断面形状を有する、装置。
- 請求項1に記載の装置において、前記装置が概ね矩形の断面形状を有する、装置。
- 請求項1に記載の装置において、前記装置が外面を有し、埋め込まれ、物質を挿入されるときに、前記インプラントの前記外面が隣接する解剖学的組織に接する突端と、解剖学的組織から離れて離間されたままとなる窪みを有する、装置。
- 請求項55に記載の装置において、前記装置は、前記突端が粘膜組織と接触し、前記窪みが粘膜組織から離れて離間されるように、被験者の鼻または副鼻腔の中での埋め込みを目的とする、装置。
- 請求項56に記載の装置において、前記装置が繊毛のある粘膜の隣に埋め込まれるためのものであり、前記窪みが、前記窪みの中の前記装置の外面が、その組織による粘液繊毛輸送機能を妨げないように繊毛のある粘膜から十分に遠く離れたままとなるように構成される、装置。
- 請求項1に記載の装置において、前記リザーバの中から、または前記障壁を通って、前記物質を移動するための装置をさらに備える、装置。
- 請求項58に記載の装置において、前記物質を移動するための該装置が、浸透圧ポンプ、機械ポンプ、電気機械ポンプ、ナノテクノロジーポンピング機構及び輸送を駆動するために電流を発する電気装置からなるグループから選択される、装置。
- 請求項1に記載の埋め込み型物質送達装置を備えるシステムにおいて、被験者の体内の埋め込みサイトに前記埋め込み型物質送達装置を送達するために使用できる送達カテーテル装置とさらに組み合わせた、システム。
- 請求項60に記載のシステムにおいて、前記送達カテーテルシステムが、
内腔と末端開口部とを有し、前記埋め込み型物質送達装置がカテーテルの内腔の中に設置されるカテーテルと、
前記埋め込み型物質送達装置に近位の前記カテーテルの前記内腔の中に配置される部材と、
前記カテーテルと、前記カテーテルの前記末端開口部の中から前記埋め込み型物質送達装置を排出するために他方を基準にして移動可能な前記部材の少なくとも1つとを備える、システム。 - 請求項61に記載のシステムにおいて、前記埋め込み型物質送達装置及び前記カテーテルの前記内腔の中に配置される前記部材が、前記システムがガイドワイヤ上で進めるために貫通して伸張するガイドワイヤ通路を有する、システム。
- 請求項61に記載のシステムにおいて、前記カテーテルは、ガイドワイヤが前記通過できるような大きさで作られた第2の内腔を備え、前記第2の内腔が以前に挿入されたガイドワイヤの中で前記システムを追跡できるようにするために使用できる、システム。
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US10/912,578 | 2004-08-04 | ||
PCT/US2005/025371 WO2006020180A2 (en) | 2004-08-04 | 2005-07-18 | Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders |
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EP1778335B1 (en) | 2013-06-12 |
CA2575361A1 (en) | 2006-02-23 |
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JP2012205930A (ja) | 2012-10-25 |
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WO2006020180A2 (en) | 2006-02-23 |
ES2427979T3 (es) | 2013-11-05 |
EP2263738A2 (en) | 2010-12-22 |
EP2258440B1 (en) | 2014-08-20 |
AU2005274794B2 (en) | 2012-01-19 |
EP2258440A2 (en) | 2010-12-08 |
US9039657B2 (en) | 2015-05-26 |
EP2258440A3 (en) | 2011-11-02 |
EP2845621B1 (en) | 2019-10-30 |
ES2523747T3 (es) | 2014-12-01 |
JP5461628B2 (ja) | 2014-04-02 |
EP1778335A2 (en) | 2007-05-02 |
EP1778335A4 (en) | 2008-07-09 |
US20130281982A1 (en) | 2013-10-24 |
JP2008508938A (ja) | 2008-03-27 |
US9039680B2 (en) | 2015-05-26 |
WO2006020180A3 (en) | 2006-06-15 |
EP2263738A3 (en) | 2011-11-09 |
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