JP6297537B2 - 耳管拡開の方法及びシステム - Google Patents
耳管拡開の方法及びシステム Download PDFInfo
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- JP6297537B2 JP6297537B2 JP2015505954A JP2015505954A JP6297537B2 JP 6297537 B2 JP6297537 B2 JP 6297537B2 JP 2015505954 A JP2015505954 A JP 2015505954A JP 2015505954 A JP2015505954 A JP 2015505954A JP 6297537 B2 JP6297537 B2 JP 6297537B2
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- catheter
- elongate shaft
- balloon
- proximal
- ear
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- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
-
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- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
-
- 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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
-
- 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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00787—Surgery of the ear
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0662—Ears
- A61M2210/0675—Eustachian tube
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/042—Force radial
- F04C2270/0421—Controlled or regulated
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Description
(1) 患者の耳管を拡開する装置であって、
第1の細長シャフトを有するガイドカテーテルであって、前記第1の細長シャフトが、近位端と、遠位端と、前記近位端と前記遠位端との間にあるルーメンとを有し、前記ガイドカテーテルが、前記第1の細長シャフトの前記近位端に取り付けられた近位ハブを有する、ガイドカテーテルと、
第2の細長シャフトを有するバルーン拡開カテーテルであって、前記第2の細長シャフトが、近位端と、遠位端とを有し、前記バルーン拡開カテーテルが、前記第2の細長シャフトの近位端と前記第2の細長シャフトの遠位端との間で前記第2の細長シャフトに連結された、前記カテーテルを片手で前進させるためのアクチュエータを有し、前記アクチュエータが、前記第2の細長シャフトを近位部分と遠位部分に分割し、近位側と遠位側とを有する、バルーン拡開カテーテルと、を具備し、
前記バルーン拡張カテーテルが、前記ガイドカテーテルのルーメンを通じて前記ガイドカテーテルと摺動可能に連結されており、前記アクチュエータの前記遠位側が前記ガイドカテーテルの前記近位端に隣接している時、前記ガイドカテーテルのルーメンに完全に挿入される、装置。
(2) 前記バルーン拡開カテーテルが、インフレータブルバルーンと、近位コネクタとを具備し、前記近位コネクタが、前記バルーンカテーテルの膨張ルーメンと流体連通されている膨張ポートを具備する、実施態様1に記載の装置。
(3) 前記近位コネクタが注入ポートを更に具備する、実施態様2に記載の装置。
(4) 前記膨張ポートが、第1のタイプのコネクタを具備し、前記注入ポートが、前記第1のタイプのコネクタとは異なる第2のタイプのコネクタを具備する、実施態様3に記載の装置。
(5) 前記ガイドカテーテルの細長シャフトが、角度が約45度〜約65度の湾曲部を有する、実施態様1に記載の装置。
(7) 前記バルーン拡開カテーテルのシャフトの遠位端が球形の先端部を有する、実施態様1に記載の装置。
(8) 前記バルーン拡開カテーテルが、
柔軟性がある近位部分と、
剛性の中間部分と、
柔軟性がある遠位部分とを具備する、実施態様1に記載の装置。
(9) 前記剛性の遠位部分がハイポチューブ(hypotube)を具備する、実施態様8に記載の装置。
(10) 患者の耳管を拡開する方法であって、
第1の細長シャフトを有するガイドカテーテルを前進させることであって、前記第1の細長シャフトが、近位端と、遠位端と、前記近位端と前記遠位端との間にあるルーメンとを有し、前記ガイドカテーテルが、前記第1の細長シャフトの前記近位端に取り付けられた近位ハブを有し、前記耳管に隣接して前記ガイドカテーテルを配置するように、前記患者の鼻腔を通じて前進させる、ことと、
第2の細長シャフトと、前記第2の細長シャフトに取り付けられたバルーンとを有するバルーン拡開カテーテルを前進させることであって、前記第2の細長シャフトが、近位端と、遠位端とを有し、前記バルーン拡開カテーテルが、前記第2の細長シャフトの近位端と前記細長シャフトの遠位端との間で前記第2の細長シャフトに連結され、前記第2の細長シャフトを近位部分と遠位部分とに分割するアクチュエータを有し、前記アクチュエータが、近位側と遠位側とを有し、前記アクチュエータの前記遠位側が前記ガイドカテーテルの前記近位端に隣接するまで、前記ガイドカテーテルの前記ルーメンを通じて前進させる、ことと、
前記バルーンを膨張させて、前記耳管の一部分を拡開することと、
前記バルーンを萎ませることと、
前記患者から前記ガイドカテーテルとバルーン拡開カテーテルとを取り外すことと、を含み、前記耳管の前記拡開された部分が、前記装置が取り外された後で少なくとも部分的に拡開されたままの状態である、方法。
(12) 前記耳管の開口部が、前記耳管の咽頭小孔を含み、前記バルーン拡開カテーテルが、前記バルーンを前記咽頭小孔内に配置するために前進される、実施態様10に記載の方法。
(13) 前記鼻腔を通じて内視鏡を前進させることと、
前記内視鏡を使用して、前記前進させること、膨張させること、萎ませること、又は取り外すことのうちの少なくとも1つを見ることと、を更に含む、実施態様10に記載の方法。
(14) 見ることが、前記バルーン拡開カテーテル上のマーカを見ることを含み、前記方法が、前記拡開器の近位端から前記マーカまでの距離に基づいて、前記耳管の前記開口部に対する前記バルーン拡開カテーテルの位置に近づくことを更に含む、実施態様13に記載の方法。
(15) 前記バルーン拡開カテーテルを使って、少なくとも1つの物質を前記耳管に塗ることを更に含む、実施態様10に記載の方法。
細長シャフトと、前記細長シャフトに取り付けられたバルーンとを有するバルーン拡開カテーテルを前進させることであって、前記細長シャフトが、近位端と、遠位端とを有し、前記バルーン拡開カテーテルが、前記細長シャフトの近位端と前記細長シャフトの遠位端との間で前記細長シャフトに連結され、前記細長シャフトを近位部分と遠位部分とに分割するアクチュエータを有し、前記アクチュエータが、近位側と遠位側とを有し、前記アクチュエータの前記遠位側が前記患者の前記鼻孔に隣接するまで、前記患者の前記鼻孔を通じて前進させる、ことと、
前記バルーンを膨張させて、前記耳管の一部分を拡開することと、
前記バルーンを萎ませることと、
前記患者の前記鼻孔から前記バルーン拡開カテーテルを取り外すことと、を含み、前記耳管の前記拡開された部分が、前記装置が取り外された後で少なくとも部分的に拡開されたままの状態である、方法。
(17) 前記耳管の開口部が、前記耳管の咽頭小孔を含み、前記バルーン拡開カテーテルが、前記バルーンを前記咽頭小孔内に配置するために前進される、実施態様16に記載の方法。
(18) 鼻腔を通じて内視鏡を前進させることと、
前記内視鏡を使用して、前記前進させること、膨張させること、萎ませること、又は取り外すことのうちの少なくとも1つを見ることと、を更に含む、実施態様16に記載の方法。
(19) 見ることが、前記バルーン拡開カテーテル上のマーカを見ることを含み、前記方法が、前記拡開器の近位端から前記マーカまでの距離に基づいて、前記耳管の前記開口部に対する前記バルーン拡開カテーテルの位置に近づくことを更に含む、実施態様16に記載の方法。
(20) 前記バルーン拡開カテーテルを使って、少なくとも1つの物質を前記耳管に塗ることを更に含む、実施態様16に記載の方法。
(22) 患者の耳管を拡開する装置であって、
第1の細長シャフトを有するガイドカテーテルであって、前記第1の細長シャフトが、近位端と、遠位端と、前記近位端と前記遠位端との間にあるルーメンとを有し、前記ガイドカテーテルが、前記細長シャフトの前記近位端に取り付けられた近位ハブを有する、ガイドカテーテルと、
第2の細長シャフトを有するバルーン拡開カテーテルであって、前記第2の細長シャフトが、近位端と、遠位端とを有し、前記バルーン拡開カテーテルが、前記第2の細長シャフトの近位端と前記第2の細長シャフトの遠位端との間で前記第2の細長シャフトに連結された、前記カテーテルを片手で前進させるためのアクチュエータを有し、前記アクチュエータが、前記第2の細長シャフトを近位部分と遠位部分に分割する、バルーン拡開カテーテルと、を具備し、
前記バルーン拡張カテーテルが、前記ガイドカテーテルのルーメンを通じて、前記ガイドカテーテルと摺動可能に連結されており、前記アクチュエータが完全に配置されている時、前記ガイドカテーテルのルーメンを通じて完全に挿入される、装置。
(23) 前記近位ハブがハンドルを具備する、実施態様22に記載の装置。
(24) 人間の患者の鼻を通じて耳管にアクセスする装置であって、前記装置は、
約45度〜約65度の曲げ角を有し、近位端と、遠位端と、前記近位端と前記遠位端との間にあるルーメンとを有する細長シャフトと、前記細長シャフトの前記近位端に取り付けられた近位ハブと、を具備する、ガイドカテーテルを具備し、
前記ガイドカテーテルが前記人間の患者の前記鼻の中に完全に配置された時に、前記近位ハブが前記人間の患者の前記鼻に接するように、前記近位ハブが前記細長シャフト上に配置される、装置。
(25) 前記細長シャフトの前記ルーメンが、少なくとも1つの物質を前記ルーメンを通して送るように更に構成されている、実施態様24に記載の装置。
細長シャフトであって、近位端と、遠位端と、前記近位端と前記遠位端との間にある膨張ルーメンとを有する、細長シャフトと、
前記細長シャフトの近位端と前記細長シャフトの遠位端との間で前記細長シャフトに連結された、前記カテーテルを片手で前進させるアクチュエータであって、前記バルーン拡開カテーテルが前記人間の患者の前記鼻の中に完全に配置された時に、前記アクチュエータが前記人間の患者の前記鼻に接するように、前記アクチュエータが前記細長シャフト上に配置される、アクチュエータと、
インフレータブルバルーンと、
前記細長シャフトの膨張ルーメンと流体連通している膨張ポートと、注入ポートとを具備する近位コネクタと、を具備する、バルーン拡開カテーテル。
(27) 前記膨張ポートが、第1のタイプのコネクタを具備し、前記注入ポートが、前記第1のタイプのコネクタとは異なる第2のタイプのコネクタを具備する、実施態様26に記載のカテーテル。
Claims (14)
- 患者の耳管を拡開する装置であって、
第1の細長シャフトを有するガイドカテーテルであって、前記第1の細長シャフトが、近位端と、遠位端と、前記近位端と前記遠位端との間にあるルーメンとを有し、前記ガイドカテーテルが、前記第1の細長シャフトの前記近位端に取り付けられた近位ハブを有する、ガイドカテーテルと、
第2の細長シャフトを有するバルーン拡開カテーテルであって、前記第2の細長シャフトが、近位端と、遠位端とを有し、前記第2の細長シャフトの前記遠位端が、前記バルーン拡開カテーテルが耳官の峡部を通過して中耳に進入することを防止する、外径2mm〜3mmである球形の先端部を有し、前記バルーン拡開カテーテルが、前記第2の細長シャフトの近位端と前記第2の細長シャフトの遠位端との間で前記第2の細長シャフトに連結された、前記カテーテルを片手で前進させるためのアクチュエータを有し、前記アクチュエータが、前記第2の細長シャフトを近位部分と遠位部分に分割し、近位側と遠位側とを有する、バルーン拡開カテーテルと、を具備し、
前記先端部が、
前記バルーン拡開カテーテルが、前記ガイドカテーテルのルーメンを通じて前記ガイドカテーテルと摺動可能に連結されており、前記アクチュエータの前記遠位側が前記ガイドカテーテルの前記近位端に隣接している時、前記ガイドカテーテルのルーメンに完全に挿入される、装置。 - 前記バルーン拡開カテーテルが、インフレータブルバルーンと、近位コネクタとを具備し、前記近位コネクタが、前記バルーンカテーテルの膨張ルーメンと流体連通されている膨張ポートを具備する、請求項1に記載の装置。
- 前記近位コネクタが注入ポートを更に具備する、請求項2に記載の装置。
- 前記膨張ポートが、第1のタイプのコネクタを具備し、前記注入ポートが、前記第1のタイプのコネクタとは異なる第2のタイプのコネクタを具備する、請求項3に記載の装置。
- 前記ガイドカテーテルの細長シャフトが、角度が約45度〜約65度の湾曲部を有する、請求項1に記載の装置。
- 前記ガイドカテーテルの細長シャフトが、角度が約55度の湾曲部を有する、請求項1に記載の装置。
- 前記バルーン拡開カテーテルが、
柔軟性がある近位部分と、
剛性の中間部分と、
柔軟性がある遠位部分とを具備する、請求項1に記載の装置。 - 前記剛性の中間部分がハイポチューブを具備する、請求項7に記載の装置。
- 患者の耳管を拡開する装置であって、
第1の細長シャフトを有するガイドカテーテルであって、前記第1の細長シャフトが、近位端と、遠位端と、前記近位端と前記遠位端との間にあるルーメンとを有し、前記ガイドカテーテルが、前記細長シャフトの前記近位端に取り付けられた近位ハブを有する、ガイドカテーテルと、
第2の細長シャフトを有するバルーン拡開カテーテルであって、前記第2の細長シャフトが、近位端と、遠位端とを有し、前記第2の細長シャフトの前記遠位端が、前記バルーン拡開カテーテルが耳官の峡部を通過して中耳に進入することを防止する、外径2mm〜3mmである球形の先端部を有し、前記バルーン拡開カテーテルが、前記第2の細長シャフトの近位端と前記第2の細長シャフトの遠位端との間で前記第2の細長シャフトに連結された、前記カテーテルを片手で前進させるためのアクチュエータを有し、前記アクチュエータが、前記第2の細長シャフトを近位部分と遠位部分に分割する、バルーン拡開カテーテルと、を具備し、
前記バルーン拡開カテーテルが、前記ガイドカテーテルのルーメンを通じて、前記ガイドカテーテルと摺動可能に連結されており、前記アクチュエータが完全に配置されている時、前記ガイドカテーテルのルーメンを通じて完全に挿入される、装置。 - 前記近位ハブがハンドルを具備する、請求項9に記載の装置。
- 前記第1の細長シャフトが、約45度〜約65度の曲げ角を有する、請求項1に記載の装置。
- 前記細長シャフトの前記ルーメンが、少なくとも1つの物質を前記ルーメンを通して送るように更に構成されている、請求項11に記載の装置。
- 人間の患者の鼻を通じて耳管にアクセスし、前記耳管を治療するバルーン拡開カテーテルであって、
細長シャフトであって、近位端と、遠位端と、前記近位端と前記遠位端との間にある膨張ルーメンとを有し、前記細長シャフトの前記遠位端が、前記バルーン拡開カテーテルが耳官の峡部を通過して中耳に進入することを防止する、外径2mm〜3mmである球形の先端部を有する、細長シャフトと、
前記細長シャフトの近位端と前記細長シャフトの遠位端との間で前記細長シャフトに連結された、前記カテーテルを片手で前進させるアクチュエータであって、前記バルーン拡開カテーテルが前記人間の患者の前記鼻の中に完全に配置された時に、前記アクチュエータが前記人間の患者の前記鼻に接するように、前記アクチュエータが前記細長シャフト上に配置される、アクチュエータと、
インフレータブルバルーンと、
前記細長シャフトの膨張ルーメンと流体連通している膨張ポートと、注入ポートとを具備する近位コネクタと、を具備する、バルーン拡開カテーテル。 - 前記膨張ポートが、第1のタイプのコネクタを具備し、前記注入ポートが、前記第1のタイプのコネクタとは異なる第2のタイプのコネクタを具備する、請求項13に記載のカテーテル。
Applications Claiming Priority (5)
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US201261623833P | 2012-04-13 | 2012-04-13 | |
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US13/826,454 | 2013-03-14 | ||
US13/826,454 US20130274715A1 (en) | 2012-04-13 | 2013-03-14 | Method and System for Eustachian Tube Dilation |
PCT/US2013/036430 WO2013155450A1 (en) | 2012-04-13 | 2013-04-12 | Method and system for eustachian tube dilation |
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EP (1) | EP2836137B8 (ja) |
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KR (1) | KR20140145619A (ja) |
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CA (1) | CA2869872A1 (ja) |
IN (1) | IN2014DN08042A (ja) |
MX (1) | MX2014012372A (ja) |
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