JP2020522309A - 腹部内圧力をモニタするためのカテーテル - Google Patents
腹部内圧力をモニタするためのカテーテル Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
- A61B5/202—Assessing bladder functions, e.g. incontinence assessment
- A61B5/205—Determining bladder or urethral pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
- A61B5/6853—Catheters with a balloon
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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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
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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
- A61M25/10—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
- A61M25/1011—Multiple 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0247—Pressure sensors
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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
- A61M2025/0001—Catheters; Hollow probes for pressure measurement
- A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
-
- 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
- A61M2025/0001—Catheters; Hollow probes for pressure measurement
- A61M2025/0003—Catheters; Hollow probes for pressure measurement having an additional lumen transmitting fluid pressure to the outside for measurement
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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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
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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
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
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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
- A61M25/0097—Catheters; Hollow probes characterised by the hub
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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
- A61M25/02—Holding devices, e.g. on the body
- A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
Abstract
Description
本願は、2017年6月3日に出願された米国特許仮出願第62/514,793号、2017年8月11日に出願された米国特許仮出願第62/544,680号、2017年11月24日に出願された米国特許仮出願第62/590,513号、2018年1月27日に出願された米国特許仮出願第62/622,871号、および2018年4月9日に出願された実用特許出願第15/949,005号の権益主張出願である。これら出願の各々を参照により引用し、これらの記載内容全体を本明細書の一部とする。
第1のルーメン、第2のルーメン、拡張型第1のバルーンおよび温度センサを有するカテーテルを用意するステップと、
尿道を通って患者の膀胱中にカテーテルを挿入するステップと、
圧力変換器を収納したハブを第1のルーメンに連結してカテーテルの第1のルーメンを通ってガスを自動的に送り進めて第1のバルーンをデフレート状態からより拡張された状態に拡張するとともに温度センサをハブ内のコネクタに自動的に接続するステップと、
流体を膀胱中に注入しないで、バルーンの変形に基づいて膀胱の第1の圧力読みを得るステップと、
第1の圧力読みをハブに連結された外部モニタに伝送するステップと、
流体を膀胱中に注入しないで、バルーンの変形に基づいて膀胱の第2の圧力読みを得るステップと、
第2の圧力読みをハブに連結された外部モニタに伝送するステップと、
流体を膀胱中に注入しないで、膀胱の逐次連続した圧力の読みを得るステップとを含む。
Claims (32)
- 圧力をモニタするために患者の体内中に挿入可能なマルチルーメン型カテーテルであって、前記カテーテルは、
前記カテーテルの遠位部分のところに設けられた拡張型外側バルーンを有し、前記外側バルーンは、第1の外壁を有し、
前記外側バルーン内に位置決めされた拡張型内側バルーンを有し、前記内側バルーンは、第2の外壁を有し、
前記内側バルーンと連通する第1のルーメンを有し、前記内側バルーンと前記第1のルーメンは、膀胱内の圧力をモニタするためにガス充填チャンバを形成し、前記外側バルーンは、前記内側バルーンの円周方向面積よりも大きい円周方向面積を有し、前記膀胱内で前記拡張後の外側バルーンの前記第1の外壁に及ぼされた圧力に応答して、前記外側バルーンは、変形し、そして圧力を前記拡張後の内側バルーンの前記第2の外壁に及ぼして前記内側バルーンを変形させると共に前記内側バルーン内および前記第1のルーメン内の前記ガスを圧縮し、それにより精密測定をもたらし、
流体を前記膀胱から取り出すよう前記膀胱と連通した第2のルーメンを有し、
前記拡張後外側バルーンによって変形された前記拡張後内側バルーンの変形によって引き起こされるガスの圧縮に基づいて膀胱内圧力を測定するために前記ガス充填チャンバと連通した圧力センサを有する、カテーテル。 - 前記ガス充填チャンバは、前記膀胱内の圧力をモニタし、それにより前記患者の腹部内の圧力をモニタする、請求項1記載のカテーテル。
- 前記圧力センサは、前記膀胱中への水の注入を必要としないで、前記カテーテルの挿入全体を通じて平均圧力を連続的に測定する、請求項1または2記載のカテーテル。
- 前記第2のルーメンは、前記内側および前記外側バルーンの遠位側に位置する側部開口部を有する、請求項1〜3のうちいずれか一に記載のカテーテル。
- 前記第2のルーメンは、前記内側および前記外側バルーンの近位側に位置する側部開口部を有する、請求項1〜4のうちいずれか一に記載のカテーテル。
- 前記カテーテルは、第4のルーメンおよび中核体温を測定するよう前記第4のルーメン内に位置決めされた温度センサを有する、請求項1〜5のうちいずれか一に記載のカテーテル。
- 前記外側バルーンは、前記膀胱の壁の平均圧力の計算のために多数の基準個所を提供するよう多数の接触領域のところで前記膀胱壁と係合可能な周囲、および前記外側バルーンをインフレートさせるよう前記外側バルーンと連通した第3のルーメンを有する、請求項1〜6のうちいずれか一に記載のカテーテル。
- 前記圧力センサは、ハブ内に収容され、前記ハブから遠位側に延びる細長い部材が設けられ、前記カテーテルの第1のポートへの前記ハブの連結により、前記細長い部材が前記第1のルーメン中に自動的に挿入されて空気を前記内側バルーン中に送り進めて前記内側バルーンを拡張させる、請求項1〜7のうちいずれか一に記載のカテーテル。
- 前記外側バルーンは、近位領域よりも大きな横断面を有する遠位領域を有する、請求項1〜8のうちいずれか一に記載のカテーテル。
- 前記カテーテルは、追加のルーメンおよび安定化バルーンをさらに有し、前記追加のルーメンは、前記安定化バルーンをインフレートさせて前記カテーテルの位置を安定化するために前記安定化バルーンと連通し、前記安定化バルーンは、前記外側バルーンの近位側に位置決めされている、請求項1〜9のうちいずれか一に記載のカテーテル。
- 腹部内圧力をモニタするマルチルーメン型カテーテルであって、前記カテーテルは、患者の膀胱中に挿入可能に形作られるとともに寸法決めされた細長い本体を有し、前記カテーテルは、第1のルーメン、第2のルーメン、第3のルーメン、遠位部分のところに設けられた第1のバルーン、および前記第1のバルーンの近位側に位置する第2のバルーンを有し、前記第1のルーメンは、前記第1のバルーンと連通し、前記第2のルーメンは、前記膀胱から流体を取り出すよう前記膀胱と連通し、前記第3のルーメンは、前記第2のバルーンをインフレートさせて前記カテーテルを安定化するよう前記第2のバルーンと連通し、前記第1のバルーンは、前記膀胱内の圧力をモニタし、それにより前記患者の腹部内の圧力をモニタするためにガス充填圧力を形成するようガスで満たされ、前記カテーテルは、前記第1のバルーンが前記膀胱内の圧力の変化に応答して形状を変化させているときに前記膀胱内の圧力を測定する圧力センサを有する、カテーテル。
- 前記圧力センサは、前記第1のバルーンに隣接して前記第1のルーメン内に位置決めされている、請求項11記載のカテーテル。
- 温度センサが圧力を測定するための前記圧力センサから軸方向に間隔を置いて位置した状態で前記第1のルーメン内に位置決めされている、請求項11または12記載のカテーテル。
- 前記圧力センサは、外部に位置し、かつ前記ガス充填チャンバと連通するよう前記カテーテルに連結可能である、請求項11〜13のうちいずれか一に記載のカテーテル。
- 前記第2のルーメンに設けられた側部開口部が前記第1のバルーンと前記第2のバルーンとの間に位置している、請求項11〜14のうちいずれか一に記載のカテーテル。
- 前記圧力センサは、膀胱内圧力を連続的に測定するとともに外部モニタと連絡して圧力の読みを視覚的に表示し、前記圧力センサは、前記膀胱中への水の注入を必要としないで、その挿入期間全体にわたって連続圧力測定をもたらす、請求項11〜15のうちいずれか一に記載のカテーテル。
- 腹部内圧力をモニタするマルチルーメン型カテーテルであって、前記カテーテルは、
前記カテーテルの遠位部分のところに設けられた遠位バルーンを有し、
前記遠位バルーンと連通した第1のルーメンを有し、前記遠位バルーンと前記第1のルーメンは、膀胱内の圧力をモニタし、それにより患者の腹部内の圧力をモニタするためにガス充填チャンバを形成し、前記膀胱内の圧力に応答して、前記遠位バルーンが変形して前記遠位バルーン内の前記ガスを圧縮し、
前記第1のルーメンと連通した第1の近位ポートを有し、
前記膀胱から流体を取り出すよう前記膀胱と連通した第2のルーメンを有し、
前記カテーテルの前記第1のポートに連結可能なハブを有し、前記ハブは、前記第1のルーメン内におけるガス圧縮に基づいて圧力を測定する圧力変換器、および前記ハブから遠位側に延びる細長い部材を有し、前記第1のポートへの前記ハブの連結により、前記細長い部材は、前記第1のルーメン中に挿入されて前記第1のルーメンを通ってガスを送り進めて前記遠位バルーンを拡張させ、前記第1のルーメンは、前記ハブが前記第1のポートに連結されたときに大気中にガス抜きされない、カテーテル。 - 前記第1のポートは、弁を有し、前記細長い部材は、前記ハブが前記カテーテルの前記第1のポートに連結されると、前記弁を通って挿入可能である、請求項21記載のカテーテル。
- 前記カテーテルを安定化するために前記遠位バルーンの近位側に設けられた安定化バルーンをさらに有する、請求項21または22記載のカテーテル。
- 前記第2のルーメンは、前記膀胱と連通した側部開口部を有し、前記側部開口部は、前記遠位バルーンの遠位側に位置決めされている、請求項21〜23のうちいずれか一に記載のカテーテル。
- 前記第2のルーメンは、前記膀胱と連通した側部開口部を有し、前記側部開口部は、前記遠位バルーンと前記安定化バルーンとの間に位置決めされている、請求項21〜23のうちいずれか一に記載のカテーテル。
- 前記圧力変換器は、前記膀胱中への水の注入を必要としないで、前記カテーテルの挿入全体にわたって平均圧力を連続的に測定する、請求項21〜25のうちいずれか一に記載のカテーテル。
- 前記カテーテルは、中核体温を測定する温度センサを有し、圧力変換器が前記ハブ内に収容され、ワイヤが前記温度センサから別のルーメンを通りかつ前記カテーテルの外側で、前記カテーテルに連結された前記ハブ中に延びている、請求項21〜26のうちいずれか一に記載のカテーテル。
- 前記カテーテルは、遠位部分のところに設けられた温度センサを有し、前記カテーテルへの前記ハブの連結により、前記温度センサは、温度モニタケーブルに自動的に電気的に接続される、請求項21〜27のうちいずれか一に記載のカテーテル。
- 前記遠位バルーンにかぶさって位置決めされた外側バルーンを有し、前記外側バルーンは、前記遠位バルーンの円周方向面積よりも大きな円周方向面積を有しかつ流体で満たされ、前記外側バルーンの外壁に及ぼされた前記膀胱内の圧力に応答して、前記外側バルーンは、変形し、そして圧力を前記遠位バルーンの外壁に及ぼして前記遠位バルーンを変形させるとともに前記遠位バルーンおよび前記第1のルーメン内の前記ガスを圧縮し、圧力センサが前記遠位バルーンの変形によって引き起こされるガス圧縮に基づいて膀胱内圧力を測定するために前記ハブによって支持されている、請求項21〜28のうちいずれか一に記載のカテーテル。
- 前記外側バルーンをインフレートさせるよう前記外側バルーンと連通した第3のルーメンをさらに有する、請求項21〜29のうちいずれか一に記載のカテーテル。
- 腹部内の圧力をモニタするマルチルーメン型カテーテルであって、前記カテーテルは、
前記カテーテルの遠位部分のところに設けられた遠位バルーンを有し、
前記遠位バルーンと連通した第1のルーメンを有し、前記遠位バルーンと前記第1のルーメンは、膀胱内の圧力をモニタし、それにより患者の腹部内の圧力をモニタするためにガス充填チャンバを形成し、前記膀胱内の圧力に応答して、前記遠位バルーンが変形して前記遠位バルーン内の前記ガスを圧縮し、
前記第1のルーメンと連通した第1の近位ポートを有し、
前記膀胱から流体を取り出すよう前記膀胱と連通した第2のルーメンを有し、
第3のルーメンおよび前記第3のルーメン内に位置決めされた温度センサを有し、前記第3のルーメンを貫通してワイヤが延び、
前記カテーテルの前記第1のポートに連結可能なハブを有し、前記ハブは、前記第1のルーメン内におけるガス圧縮に基づいて圧力を測定する圧力変換器を有し、前記第1のポートへの前記ハブの連結により、前記ワイヤは、温度モニタへの接続のために前記ハブ内の電気コネクタに自動的に接続される、カテーテル。 - 前記第1のポートへの前記ハブの連結により、ガスが前記遠位バルーン中に自動的に送り進められて前記遠位バルーンを拡張させ、前記第1のルーメンは、前記遠位バルーンの拡張中、外気に対して封止状態のままである、請求項31記載のカテーテル。
- 前記ハブは、前記ハブから遠位側に延びかつ前記第1のポートへの前記ハブの連結時にガスを前記遠位バルーン中に送り進めるよう前記第1のルーメン中に挿入可能な細長い部材を有する、請求項32記載のカテーテル。
- 前記第1のポートは、弁を有し、前記細長い部材は、前記ハブが前記カテーテルに連結されると、前記弁を通って挿入可能である、請求項33記載のカテーテル。
- 前記遠位バルーンにかぶさって位置決めされた外側バルーンを有し、前記外側バルーンは、前記遠位バルーンの円周方向面積よりも大きな円周方向面積を有しかつ流体で満たされ、前記外側バルーンの外壁に及ぼされた前記膀胱内の圧力に応答して、前記外側バルーンは、変形し、そして圧力を前記遠位バルーンの外壁に及ぼして前記遠位バルーンを変形させるとともに前記遠位バルーンおよび前記第1のルーメン内の前記ガスを圧縮する、請求項31〜34のうちいずれか一に記載のカテーテル。
- 前記カテーテルを安定化するために前記遠位バルーンの近位側に位置決めされた安定化バルーンをさらに有する、請求項31〜35のうちいずれか一に記載のカテーテル。
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CA3060938A1 (en) | 2018-12-06 |
US20180344234A1 (en) | 2018-12-06 |
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WO2018222295A1 (en) | 2018-12-06 |
US11045128B2 (en) | 2021-06-29 |
US11832947B2 (en) | 2023-12-05 |
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