JP7267401B2 - 拡張可能な特性を有するイントロデューサ - Google Patents
拡張可能な特性を有するイントロデューサ Download PDFInfo
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- JP7267401B2 JP7267401B2 JP2021510850A JP2021510850A JP7267401B2 JP 7267401 B2 JP7267401 B2 JP 7267401B2 JP 2021510850 A JP2021510850 A JP 2021510850A JP 2021510850 A JP2021510850 A JP 2021510850A JP 7267401 B2 JP7267401 B2 JP 7267401B2
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- inner liner
- outer sheath
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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
- A61M25/0009—Making of catheters or other medical or surgical 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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
-
- 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
-
- 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
-
- 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
- A61M25/0021—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
- A61M2025/0024—Expandable catheters or sheaths
-
- 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
- A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/001—Forming the tip of a catheter, e.g. bevelling process, join or taper
-
- 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
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- 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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
Description
追加的又は代替的に、及び第三の態様において、ルーメンは、送達状態での第一の直径と拡張状態での第二の直径を有し、第二の直径は第一の直径より大きい。
追加的又は代替的に、及び第七の態様において、内側ライナは非弾性材料で形成される。
追加的又は代替的に、及び第九の態様において、複数の長さ方向すじ状突起のうちの1つ又は複数は、補強部材の長さの少なくとも一部に沿って先端方向に減少する幅を有する。
追加的又は代替的に、及び第十五の態様において、少なくとも1つの穿孔は、内側ライナが折り畳み状態から拡張状態へと拡張したことに応答して分離するように構成された、外側シースに沿った好ましい引裂き線を形成する。
追加的又は代替的に、及び第十九の態様において、複数の窓の各々はある距離だけ長さ方向に分離され、この距離は外側シースの長さに沿って変化する。
すべての数値は本明細書において、明示されているか否かを問わず、「約」という用語で修飾されると仮定される。「約」という用語は、数値に関しては一般に、明示されている値と同等である(例えば、同じ機能又は結果を有する)と当業者が考える数値の範囲を指す。多くの例において、「約」という用語は最も近い有効数字に丸められる数を含むことがある。「約」という用語のその他の使用(例えば数値以外に関する)は、別段の明示がないかぎり、本明細書の文脈から理解され、それと矛盾しないそれぞれの通常の慣例的な定義を有すると仮定されてよい。
Claims (15)
- 多層管状部材であって、
内側ライナであって、ルーメン、先端領域、及び送達状態において前記内側ライナの前記先端領域に沿って延びる少なくとも1つの折り畳み部を含む内側ライナと、
前記内側ライナの少なくとも一部を覆って配置される補強部材であって、ある長さを有し、複数の長さ方向すじ状突起であって、隣接するすじ状突起間に配置された複数の開口を画定する複数の長さ方向すじ状突起を含み、各折り畳み部には前記複数の開口のうちの1つが円周上で重なる、補強部材と、
前記補強部材を覆って配置された外側シースであって、各折り畳み部と円周上で重なる少なくとも1つの穿孔を含む外側シースと、を含む多層管状部材と、
前記多層管状部材のテーパ状先端領域に固定して取り付けられた先端部材と、
を備えるイントロデューサにおいて、
前記内側ライナは、前記多層管状部材の先端部まで延び、
各折り畳み部の全体は、前記多層管状部材の前記先端部の基端側で終了し、
前記テーパ状先端領域は各折り畳み部を欠いているイントロデューサ。 - 前記内側ライナは、前記送達状態から拡張状態へと半径方向に拡張するように構成される、請求項1に記載のイントロデューサ。
- 前記ルーメンは、前記送達状態での第一の直径と前記拡張状態での第二の直径を有し、前記第二の直径は前記第一の直径より大きい、請求項2に記載のイントロデューサ。
- 前記少なくとも1つの折り畳み部の少なくとも1つは、前記内側ライナが前記送達状態から前記拡張状態へと半径方向に拡張するときに少なくとも部分的に展開する、請求項2又は3に記載のイントロデューサ。
- 前記多層管状部材は、各折り畳み部と半径方向に整列し、前記テーパ状先端領域内で、前記多層管状部材の前記先端部から基端側に延びる切欠き部を含む、請求項1~4の何れか1項に記載のイントロデューサ。
- 前記多層管状部材の前記テーパ状先端領域は、第一の外径から、前記第一の外径より小さい第二の外径へと先端方向にテーパ状である、請求項1~5の何れか1項に記載のイントロデューサ。
- 前記内側ライナは非弾性材料で形成される、請求項1~6の何れか1項に記載のイントロデューサ。
- 前記複数の長さ方向すじ状突起のうちの1つ又は複数は、前記補強部材の長さに沿って実質的に一定の幅を有する、請求項1~7の何れか1項に記載のイントロデューサ。
- 前記複数の長さ方向すじ状突起のうちの1つ又は複数は、前記補強部材の長さの少なくとも一部に沿って先端方向に減少する幅を有する、請求項1~8の何れか1項に記載のイントロデューサ。
- イントロデューサの製造方法において、
第一のマンドレルに補強部材を位置付けることであって、前記補強部材は、ある長さを有し、複数の長さ方向すじ状突起であって、隣接する長さ方向すじ状突起間に配置された複数の開口を画定する複数の長さ方向すじ状突起を含むことと、
前記第一のマンドレル上の前記補強部材を覆うように外側シースを配置することであって、前記外側シースは、前記複数の開口のうちの1つと円周上で重なる少なくとも1つの穿孔を含むことと、
前記外側シースを前記補強部材に結合することと、
内側ライナを第二のマンドレルに巻き付け、前記内側ライナの先端領域に沿って延びる少なくとも1つの折り畳み部を有する折り畳み状態を形成することと、
前記外側シースと前記補強部材とを前記第二のマンドレルの上の前記内側ライナの少なくとも一部を覆うように配置して、多層管状部材を形成することであって、前記少なくとも1つの穿孔は各折り畳み部と円周上で重なることと、
前記多層管状部材の先端部に隣接する前記多層管状部材の円周に沿った材料を除去して、前記多層管状部材のテーパ状先端領域を形成することと、
前記テーパ状先端領域の中の前記内側ライナから各折り畳み部の全体を除去することと、
前記テーパ状先端領域に先端部材を固定して取り付けるステップと、
を含む製造方法。 - 前記外側シースを前記補強部材に結合することは、前記補強部材と前記外側シースを加熱して、前記補強部材と前記外側シースとの間にリフローを誘導するステップを含む、請求項10に記載の方法。
- 前記多層管状部材の円周に沿った材料を除去する前に、前記外側シース、前記補強部材、及び前記内側ライナを加熱して、前記外側シースおよび前記補強部材のリフローを前記内側ライナの付近に誘導し、それによって前記外側シースと前記補強部材とを前記内側ライナに結合して、前記多層管状部材を形成することをさらに含む、請求項10~11の何れか1項に記載の方法。
- 前記テーパ状先端領域の中の前記内側ライナから各折り畳み部の少なくとも一部を除去することは、前記外側シースのうち、前記多層管状部材の前記テーパ状先端領域内の各折り畳み部と重複する部分を除去することを含む、請求項10~12の何れか1項に記載の方法。
- 前記先端部材は、前記外側シース、前記補強部材、又は前記内側ライナよりデュロメータ硬さの低い材料から形成される、請求項10~13の何れか1項に記載の方法。
- 前記少なくとも1つの穿孔は、前記内側ライナが前記折り畳み状態から拡張状態へと拡張したことに応答して分離するように構成された、前記外側シースに沿った好ましい引裂き線を形成する、請求項10~14の何れか1項に記載の方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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US201862729238P | 2018-09-10 | 2018-09-10 | |
US62/729,238 | 2018-09-10 | ||
US201862731779P | 2018-09-14 | 2018-09-14 | |
US62/731,779 | 2018-09-14 | ||
PCT/US2019/050344 WO2020055820A1 (en) | 2018-09-10 | 2019-09-10 | Introducer with expandable capabilities |
Publications (2)
Publication Number | Publication Date |
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JP2021534903A JP2021534903A (ja) | 2021-12-16 |
JP7267401B2 true JP7267401B2 (ja) | 2023-05-01 |
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JP2021510850A Active JP7267401B2 (ja) | 2018-09-10 | 2019-09-10 | 拡張可能な特性を有するイントロデューサ |
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Country | Link |
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US (1) | US11565093B2 (ja) |
EP (2) | EP4129382A1 (ja) |
JP (1) | JP7267401B2 (ja) |
CN (1) | CN112969492B (ja) |
WO (1) | WO2020055820A1 (ja) |
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WO2022098872A1 (en) * | 2020-11-04 | 2022-05-12 | Edwards Lifesciences Corporation | Expandable sheath for introducing an endovascular delivery device into a body |
BR112023025539A2 (pt) * | 2021-06-10 | 2024-02-27 | Edwards Lifesciences Corp | Bainha expansível para introdução de um dispositivo de distribuição endovascular em um corpo |
WO2023147422A2 (en) * | 2022-01-27 | 2023-08-03 | Medtronic, Inc. | Expandable introducer |
WO2023212766A1 (en) * | 2022-05-04 | 2023-11-09 | Three Peaks Medical Pty Ltd | Improvements to introducer sheaths |
US20230364393A1 (en) * | 2022-05-12 | 2023-11-16 | Abiomed, Inc. | Expandable sheath and liner therefor |
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WO2020055820A1 (en) | 2020-03-19 |
CN112969492B (zh) | 2023-03-24 |
EP3849646B1 (en) | 2022-10-26 |
CN112969492A (zh) | 2021-06-15 |
US20200078571A1 (en) | 2020-03-12 |
EP4129382A1 (en) | 2023-02-08 |
JP2021534903A (ja) | 2021-12-16 |
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US11565093B2 (en) | 2023-01-31 |
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