JP2015109990A - 拡開カテーテル - Google Patents
拡開カテーテル Download PDFInfo
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- JP2015109990A JP2015109990A JP2015005722A JP2015005722A JP2015109990A JP 2015109990 A JP2015109990 A JP 2015109990A JP 2015005722 A JP2015005722 A JP 2015005722A JP 2015005722 A JP2015005722 A JP 2015005722A JP 2015109990 A JP2015109990 A JP 2015109990A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A61M29/02—Dilators made of swellable material
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- A61B1/227—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for ears, i.e. otoscopes
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- A61B1/233—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the nose, i.e. nasoscopes, e.g. testing of patency of Eustachian tubes
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- A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
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- A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
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Abstract
【解決手段】患者の耳管ETを拡開するための拡開カテーテル1606は、シャフト、及び、該シャフトに連結されていて、耳管内で位置付け可能であり、耳管を拡張するための拡開器1608を含み、拡開カテーテルのシャフト上の目印を更に備え、拡開器の近位端部からの目印の距離に基づいて、患者の耳管の開口部に対する拡開器の位置を特定する。
【選択図】図16B
Description
本出願は、2007年12月20日に出願された米国特許仮出願第61/015,647号の恩恵を主張する、2008年12月19日に出願された米国特許出願第12/340,226号の一部継続出願であり、その開示内容の全体を全ての目的で本明細書に組み入れる。
本発明の1つの実施形態は、最小侵襲技術を使用し、耳管を超えて中耳へのアクセスを得ることに関する。1つの実施形態において、中耳洞は、耳管(ET)を介してアクセスされてもよい。耳管オリフィスへの本アクセスを獲得するために、約30度を超え、かつ約90度より小さい屈曲をその遠位端に有するガイドカテーテルが、使用されてもよい。アクセスした後、診断用デバイス又は介入デバイスが、耳管の中へ導入されてもよい。任意で、繊細な中耳構造に損傷を与えるのを防ぐため、安全機構が採用されてもよい。1つの実施形態において、安全機構は、図7に示されるように、鼓膜を介して中耳の中へ導入されるプローブ及び/又はセンサを含んでもよい。例えば、プローブは内視鏡であってもよく、センサは電磁変換器であってもよい。
本発明の別の実施形態は、中耳及びその構造の疾病の診断に関する。1つの実施形態において、診断は、ガイドカテーテル100を通して定位置へと前進される内視鏡の使用を含んでもよい。内視鏡の設計は、90度又はそれ以上のY軸線視覚化、及び360度回転を可能にする。そのような内視鏡は、真珠腫、小骨の機能及び/又は疾病、及び術後経過観察の評価のために使用されてもよい。上述のように適合されうる代表的な内視鏡は、Medigus製のIntroSpicio 115 1.8mmカメラを使用してもよい。そのようなカメラは、約1.8mm×1.8mmであり、その小型の剛性部分により、内視鏡の先端で最大限の可撓性が可能である。
本発明の別の実施形態は、耳管疾患の治療に関する。いくつかの場合では、例えば、耳管疾患は耳管の構造的な閉塞に関連することがある。耳管の構造疾患は、多くの場合、図8に示されるように、耳管内又はその周辺の解剖学的異常、若しくは過剰組織又は浮腫状組織の結果である。図8は、耳管ET周辺の解剖学的領域区分を示す。図8は、鼓膜TM、頚動脈、ET軟骨、及び、口蓋帆張筋及び口蓋帆挙筋の場所を含む、一般的な解剖学的ランドマークを示す。図9〜10は、ET周辺の領域で実行される、診断的又は治療的手技を示す。
図15Aは、1つの実施形態に従って耳管を治療するためのデバイス1500を示す。デバイス1500は、細長い剛性シャフト1502を含む。剛性シャフトは、半可撓性金属又はプラスチックで構築されてもよい。デバイス1500に関して使用される「剛性」とは、シャフト1502を鼻の孔の中へと挿入するときに、シャフト1502が変形しないということを意味する。剛性シャフト1502は、可鍛性材料で形成され、現場で使用時に用途に合わせて屈曲されてもよい。治療用デバイス、この例では細長い可撓性インサート1504は、剛性シャフト1502の遠位部に連結される。シャフトが耳管に進入するのを防ぐために、止め具(図示せず)が、インサート1504/シャフト1502接合部に定置されてもよい。インサート1504は、耳管の中へ挿入されたときに、インサート1504が耳管の通路に沿い、耳管を著しく変形させないように、優先的に横剛性を有する。インサート1504はまた、あらかじめ成形された形状(図示せず)を含んでもよく、例えば、耳管の解剖学的構造へとあらかじめ成形される。インサート1504は、折り畳まれたり座屈したりすることなく耳管の中へ挿入するのに十分な強度の、縦剛性を優先的に有する。インサート1504のこの例は、コアワイヤ1506及び拡張可能バルーン1508を含む。コアワイヤ1506は、ステンレス鋼等の金属、又はニッケルチタン等の超弾性合金で構築されてもよい。.05〜.25mmの範囲のコアワイヤ1508直径が好適でありうる。バルーン1508は、柔軟性、半柔軟性、又は非柔軟性の構築物であってもよい。バルーン1508は、耳管の輪郭に一致するあらかじめ成形された形状を含んでもよい。バルーン1508は、部分的に又は完全に拡張した際に、本明細書に開示される治療用物質のうちの任意のものを送達するための、微小孔を含んでもよい。バルーン1508は、本明細書に開示される治療用物質のうちの任意のものを送達するためのコーティングを含んでもよい。デバイス1500は、球形状の無傷端1510を含んでもよく、それはコアワイヤ1506と一体化してもよい。デバイス1500は、シャフト1502の近位部に、インサート1504へ流体、エネルギー、及び電気信号を供給するための継手1511を含んでもよい。したがってデバイス1500は、流体の通過のためのルーメンを含んでもよい。デバイス1500は、耳管内への挿入のためにガイドワイヤを必要としないが、しかしながら、任意でガイドワイヤを使用してもよい。
(1) 患者の耳管を拡開するためのシステムであって、
前記患者の鼻腔を通して前進可能であり、かつ前記患者の前記耳管の開口部又はその近くに位置付け可能な遠位端部を含む、ガイドカテーテルであって、前記ガイドカテーテルの遠位部が30度〜90度の角度を有する屈曲を含み、前記遠位部が前記ガイドカテーテルの近位部より可撓性である、ガイドカテーテルと、
ガイドワイヤであって、前記ガイドワイヤの遠位端部が前記耳管へ進入することができるように、前記ガイドカテーテルを通して前進可能な、ガイドワイヤと、
前記ガイドワイヤ上で前進可能であり、かつ前記耳管内で位置付け可能であり、前記耳管を拡張するための拡開器を含む、拡開カテーテルと、を備える、システム。
(2) 前記ガイドカテーテルの前記遠位部が可鍛性である、実施態様1に記載のシステム。
(3) 前記耳管の前記開口部が前記耳管の咽頭口を含み、前記拡開カテーテルの前記拡開器が前記咽頭口内で位置付け可能である、実施態様1に記載のシステム。
(4) 前記ガイドワイヤが照明ガイドワイヤを備える、実施態様1に記載のシステム。
(5) 前記照明ガイドワイヤから照射される光を観察するための内視鏡を更に備える、実施態様4に記載のシステム。
(6) 前記ガイドカテーテルが、前記拡開カテーテルが前記ガイドワイヤ上で前進される前に、前記患者から除去可能である、実施態様1に記載のシステム。
(7) 前記耳管内で定置されるよう寸法決めされるステントを更に備える、実施態様1に記載のシステム。
(8) 前記拡開カテーテルが、前記拡開器の位置を維持するための、バルーンに隣接する側方翼を含む、実施態様1に記載のシステム。
(9) 前記拡開器が、膨張されると、前記耳管ETの咽頭口の円錐開口に一致するように成形される、実施態様1に記載のシステム。
(10) 前記拡開器が、前記耳管の全体を占有しない断面を有するように成形される、実施態様1に記載のシステム。
(12) 前記拡開カテーテルが、前記拡開器の近位端部からの目印の距離を特定するための、前記カテーテルのシャフト上の前記目印を更に備える、実施態様1に記載のシステム。
(13) 前記拡開器を使用して、前記耳管に少なくとも1つの物質を適用するための構造を更に備える、実施態様1に記載のシステム。
(14) 前記拡開器が、前記物質を送達するための多孔質バルーンを備える、実施態様13に記載のシステム。
(15) 前記拡開器が、前記物質を送達するための複数の針を有するバルーンを備える、実施態様13に記載のシステム。
(16) 前記拡開カテーテルが、前記拡開器の位置を拡張中に維持するように前記耳管に対して力を印加するための手段を含む、実施態様1に記載のシステム。
(17) 患者の耳管を拡開するためのシステムであって、
前記患者の鼻腔を通して前進可能であり、かつ前記患者の前記耳管の開口部又はその近くに位置付け可能な遠位端部を含む、ガイドカテーテルであって、前記ガイドカテーテルの遠位部が30度〜90度の角度を有する屈曲を含み、前記遠位部が前記ガイドカテーテルの近位部より可撓性である、ガイドカテーテルと、
送達カテーテルであって、前記耳管内に前記送達カテーテルを定置するように前記ガイドカテーテルを通して前進可能な、送達カテーテルと、
前記送達カテーテルを使用して前記耳管の中へ前進可能な、細長い物質送達デバイスと、を備える、システム。
(18) 前記細長い物質送達デバイスが、少なくとも1つの物質を溶出させるように構成される細長い紐状体である、実施態様17に記載のシステム。
(19) 前記細長い紐状体が、前記送達カテーテルの内側から前進可能である、実施態様18に記載のシステム。
(20) 前記細長い紐状体が、前記送達カテーテルの外側から取り外し可能である、実施態様18に記載のシステム。
(22) 前記バルーンが、前記バルーンを膨張させることによって前記送達カテーテルから切り離されうる、実施態様21に記載のシステム。
(23) 前記バルーンが、前記耳管内の均圧を可能にするように構成される、実施態様22に記載のシステム。
(24) 前記細長い物質送達デバイスが、拡張可能ステントである、実施態様17に記載のシステム。
(25) 前記拡張可能ステントが前記耳管内で拡張するように構成される、実施態様24に記載のシステム。
(26) 前記細長い物質送達デバイスが、複数の支柱に接続される細長い中心部材を含む、細長いインサートであり、各支柱が細長い外側部材に接続される、実施態様17に記載のシステム。
(27) 前記支柱が、前記耳管内に空間を提供及び維持し、その中の均圧を維持する、実施態様26に記載のシステム。
(28) 患者の耳管を拡開するための拡開カテーテルであって、
シャフト、及び、該シャフトに連結されていて、前記耳管内で位置付け可能であり、前記耳管を拡張するための拡開器を含み、
前記拡開カテーテルのシャフト上の目印を更に備え、前記拡開器の近位端部からの前記目印の距離に基づいて、前記患者の前記耳管の前記開口部に対する前記拡開器の位置を特定する、拡開カテーテル。
(29) 前記耳管の前記開口部が前記耳管の咽頭口を含み、前記拡開カテーテルの前記拡開器が前記咽頭口内で位置付け可能である。
(30) 前記拡開器が、膨張されると、前記耳管ETの咽頭口の円錐開口に一致するように成形される。
(31) 前記拡開器が、前記耳管の全体を占有しない断面を有するように成形される。
(32) 前記拡開器が切断部材を含む。
(33) 前記拡開器を使用して、前記耳管に少なくとも1つの物質を適用するための構造を更に備える。
(34) 前記拡開器が、前記物質を送達するための多孔質バルーンを備える。
(35) 前記拡開器が、前記物質を送達するための複数の針を有するバルーンを備える。
Claims (8)
- 患者の耳管を拡開するための拡開カテーテルであって、
シャフト、及び、該シャフトに連結されていて、前記耳管内で位置付け可能であり、前記耳管を拡張するための拡開器を含み、
前記拡開カテーテルのシャフト上の目印を更に備え、前記拡開器の近位端部からの前記目印の距離に基づいて、前記患者の前記耳管の前記開口部に対する前記拡開器の位置を特定する、拡開カテーテル。 - 前記耳管の前記開口部が前記耳管の咽頭口を含み、前記拡開カテーテルの前記拡開器が前記咽頭口内で位置付け可能である、請求項1に記載の拡開カテーテル。
- 前記拡開器が、膨張されると、前記耳管ETの咽頭口の円錐開口に一致するように成形される、請求項1に記載の拡開カテーテル。
- 前記拡開器が、前記耳管の全体を占有しない断面を有するように成形される、請求項1に記載の拡開カテーテル。
- 前記拡開器が切断部材を含む、請求項1に記載の拡開カテーテル。
- 前記拡開器を使用して、前記耳管に少なくとも1つの物質を適用するための構造を更に備える、請求項1に記載の拡開カテーテル。
- 前記拡開器が、前記物質を送達するための多孔質バルーンを備える、請求項6に記載の拡開カテーテル。
- 前記拡開器が、前記物質を送達するための複数の針を有するバルーンを備える、請求項6に記載の拡開カテーテル。
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EP2519300B1 (en) | 2020-08-12 |
AU2010339585A1 (en) | 2012-07-26 |
KR101885510B1 (ko) | 2018-08-07 |
US20100198191A1 (en) | 2010-08-05 |
RU2559017C2 (ru) | 2015-08-10 |
RU2012132456A (ru) | 2014-02-10 |
CN102740920A (zh) | 2012-10-17 |
CA2785652A1 (en) | 2011-07-07 |
EP2519300A1 (en) | 2012-11-07 |
KR20120098940A (ko) | 2012-09-05 |
WO2011082139A1 (en) | 2011-07-07 |
MX2012007725A (es) | 2012-08-15 |
JP2013515591A (ja) | 2013-05-09 |
KR20180014855A (ko) | 2018-02-09 |
JP5714607B2 (ja) | 2015-05-07 |
BR112012016196A2 (pt) | 2017-09-12 |
KR101825346B1 (ko) | 2018-02-05 |
CN102740920B (zh) | 2016-10-26 |
JP5944541B2 (ja) | 2016-07-05 |
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