JP2018527149A - 組織空洞内にシースを係留するためのデバイスおよび方法 - Google Patents
組織空洞内にシースを係留するためのデバイスおよび方法 Download PDFInfo
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- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/4404—Details or parts
- A61F5/4408—Means for securing receptacles or bags to the body otherwise than by adhesives, e.g. belts, straps or harnesses
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- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
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Abstract
Description
本発明の現在請求されている実施形態の分野は、医療デバイス、より具体的には、組織空洞内に医療デバイスを係留することに関する。
外科的腸切除および吻合後、または腸壁が損傷されたときの糞便流からの腸管腔の一時的保護の必要性は、従来、造瘻の作成を通した腸の外部迂回路の作成によって達成されている。造瘻は、消化(GI)管の一区画と前腹壁の皮膚との間の意図的な吻合である。造瘻は、GI管に沿って、事実上どこにでも作成されることができる。糞便流の迂回に関して、最も一般的な造瘻は、遠位小腸(例えば、回腸造瘻)および大腸(例えば、結腸造瘻)を伴う。造瘻は、米国で300,000人の患者、および世界中で200万人を超える患者で行われているが、本手術は、高い罹患率、死亡率、および患者の生活の質への重大な影響によって複雑化される。多くの造瘻が、一時的であることを意図しているが、一時的造瘻の1/3もの症例が決して回復しない。故に、糞便迂回のための低罹患率代替物を提供する改良された方法およびデバイスの必要性がある。
Claims (30)
- 第1の管腔を画定する内側表面を有する、スリーブと、
前記スリーブの近位端に配置される、第1の環状密閉機構と、
前記スリーブの遠位端に配置される、第2の環状密閉機構と、
前記スリーブの外側表面と流体接続する圧力管と、
前記スリーブと機械接続するシースであって、前記シースは、第2の管腔を形成し、前記第2の管腔は、前記第1の管腔と流体接続する、シースと、
前記スリーブの前記外側表面上に配置される、連続気泡発泡体と、
を備え、
前記圧力管への陰圧の印加は、前記第1および第2の環状密閉機構と組織空洞の内側表面との間にシールを形成させ、
前記圧力管への陰圧の前記印加は、前記スリーブの変位に抵抗する摩擦力を生成する、
係留システム。 - 前記圧力管への陰圧の前記印加は、前記スリーブの前記外側表面上に配置された前記連続気泡発泡体を前記組織空洞の前記内側表面と接触させ、それによって、前記スリーブの変位に抵抗する前記摩擦力を生成する、請求項1に記載の係留システム。
- 前記第1および第2の環状密閉機構は、前記組織空洞の前記内側表面と実質的に気密性および液密性のシールを形成する、請求項1に記載の係留システム。
- 前記シースは、前記スリーブより遠位の糞便流から前記組織空洞の前記内側表面を保護する、請求項1に記載の係留システム。
- 前記第1の管腔は、約1cm〜約6cmの直径を有する、請求項1に記載の係留システム。
- 前記スリーブの前記外側表面は、約1.1cm〜約6.1cmの直径を有する、請求項1に記載の係留システム。
- 前記連続気泡発泡体は、約50ミクロン〜約1,000ミクロンの平均細孔径を有する材料を備える、請求項1に記載の係留システム。
- 前記連続気泡発泡体は、患者の腸の蠕動収縮によって圧縮可能である、請求項1に記載の係留システム。
- 前記スリーブは、約20A〜約70AのショアA硬度を有する可撓性材料を備える、請求項1に記載の係留システム。
- 前記連続気泡発泡体は、ポリビニルアルコール、ポリウレタンフォーム、または他の合成ポリマーを備える、請求項1に記載の係留システム。
- 前記連続気泡発泡体は、少なくとも50kpaの引張強度を有する、請求項1に記載の係留システム。
- 前記連続気泡発泡体は、2mm〜150mmの厚さを有する、請求項1に記載の係留システム。
- 前記第1および第2の環状密閉機構は、約20A〜約70AのショアA硬度を有する可撓性材料を備える、請求項1に記載の係留システム。
- 前記第1および第2の環状密閉機構は、前記スリーブの周囲に分散された前記連続気泡発泡体の環状直径を上回る環状直径を有する、請求項1に記載の係留システム。
- 前記第1および第2の環状密閉機構は、陰圧が前記圧力管を通して送達されるときに、1つまたはそれを上回るテーパ状フィンが前記組織空洞の前記内側表面に接して平らになるように、前記スリーブの中心から離れて指向された配向で前記スリーブの各端部上で直列に留置される、前記1つまたはそれを上回るテーパ状フィンを備える、請求項1に記載の係留システム。
- 前記第1および第2の環状密閉機構は、丸みを帯びた突出、または圧縮可能である前記スリーブの各端部で直列に留置される複数の突出を備える、請求項1に記載の係留システム。
- 陰圧源をさらに備え、陰圧は、−50mmHg〜−200mmHgのレベルで一定の陰圧を維持するように、前記陰圧源によって前記圧力管に印加される、請求項1に記載の係留システム。
- 前記シースは、それが前記組織空洞の外側に延在することを可能にする長さを有する、請求項1に記載の係留システム。
- 前記第1の管腔、第2の管腔、ならびに第1および第2の環状密閉機構は、患者の腸の通常の蠕動力によって圧縮可能である、請求項1に記載の係留システム。
- 前記スリーブは、約3cm〜約25cmである長さを有する、請求項1に記載の係留システム。
- 前記スリーブ、第1および第2の密閉機構、ならびにシースは、シリコーン、ポリウレタン、熱可塑性エラストマ、ゴム、ゴム様材料、または他のポリマーのうちの1つもしくはそれを上回るものから成る、請求項1に記載の係留システム。
- 前記スリーブの前記外側表面と流体接続する複数の圧力管をさらに備える、請求項1に記載の係留システム。
- 前記スリーブ、前記第1の環状密閉機構、および第2の環状密閉機構は、第1の係留要素を形成し、前記係留システムはさらに、
前記シースと機械接続する第2の係留要素であって、前記第2の係留要素は、前記第1の係留要素から離れて配置され、それより遠位にある、第2の係留要素と、
前記第1の係留要素と前記第2の係留要素との間に配置される、ポートと、
を備え、
前記シース、前記第1の係留要素、および前記第2の係留要素は、前記第1および第2の係留要素、前記シース、ならびに前記組織空洞の前記内側表面の間に密封空間を作成し、
前記ポートは、流体送達および採取のために患者の身体の外側からのアクセスを可能にするように前記密封空間と連通する、
請求項1に記載の係留システム。 - 前記第1の環状密閉機構および前記第2の環状密閉機構の直径は、前記シースが係留される、前記組織空洞の直径未満またはそれと等しい、請求項1に記載の係留システム。
- 請求項1に記載の係留システムを包み込む、可撓性管状膜と、
近位端、遠位端、および中心を伴う半剛性管プッシャと、
を備え、
前記係留システムは、患者の腸の中へ前記半剛性管プッシャを前進させることによって、定位置に押動されるように構成され、
前記可撓性管状膜は、前記半剛性管プッシャの前記近位端に陥入して前記遠位端から出る、
送達システム。 - 前記送達システムは、縦牽引力が前記可撓性管状膜に印加されるときに、前記係留システムを圧縮し、前記係留システムを前記半剛性管プッシャに保持する、請求項25に記載の送達システム。
- 前記係留システムの留置後に、半剛性管プッシャから取り外され、前記半剛性管プッシャの前記中心を通して患者の身体から抽出されることができる、可撓性部材をさらに備える、請求項26に記載の送達システム。
- 腸管腔を通して糞便流を迂回させるための一時的係留デバイスであって、
第1の管腔を画定する内側表面を有する、スリーブと、
前記スリーブの近位端に配置される、第1の環状密閉機構と、
前記スリーブの遠位端に配置される、第2の環状密閉機構と、
前記スリーブの外側表面と流体接続する圧力管と、
前記スリーブと機械接続するシースであって、前記シースは、第2の管腔を形成し、前記第2の管腔は、前記第1の管腔と流体接続する、シースと、
前記スリーブの前記外側表面上に配置される、空気伝導粗面材料と、
を備え、
前記圧力管への陰圧の印加は、前記第1および第2の環状密閉機構と前記腸管腔の内側表面との間にシールを形成させ、
前記圧力管への陰圧の前記印加は、前記スリーブの変位に抵抗する摩擦力を生成する、
一時的係留デバイス。 - 前記空気伝導粗面材料は、積層メッシュ行列、前記スリーブの周囲に半径方向様式で配向される、相互接続されたチャネルのハニカム格子、ガーゼ、織物、または3次元織成材料である、請求項28に記載の腸管腔を通して糞便流を迂回させるための一時的係留デバイス。
- 組織空洞の中でシースを係留するための方法であって、前記シースは、スリーブと機械接続し、前記スリーブは、前記組織空洞の内壁に接触するための発泡体を備える、外側表面と、前記組織空洞の残りの部分から前記スリーブに隣接する前記組織空洞の一部を隔離するための密閉機構とを有し、
前記組織空洞の中に前記スリーブを挿入するステップと、
前記スリーブの外側表面と前記組織空洞の前記隔離された部分の内側表面との間の領域に陰圧を印加し、前記スリーブの前記外側表面と前記組織空洞の前記内側表面との間に摩擦力を生成するステップと、
を含む、方法。
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US20180125699A1 (en) | 2018-05-10 |
JP7422438B2 (ja) | 2024-01-26 |
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AU2022202828B2 (en) | 2024-03-28 |
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JP6823875B2 (ja) | 2021-02-03 |
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EP3349668A1 (en) | 2018-07-25 |
CN113384390B (zh) | 2023-08-22 |
AU2022202828A1 (en) | 2022-05-19 |
CN108271347B (zh) | 2021-04-20 |
US20210145624A1 (en) | 2021-05-20 |
JP7248327B2 (ja) | 2023-03-29 |
CA2998170A1 (en) | 2017-03-23 |
AU2016323425B2 (en) | 2020-10-22 |
EP4226868A1 (en) | 2023-08-16 |
AU2016323425A1 (en) | 2018-03-29 |
US9827135B2 (en) | 2017-11-28 |
US11903865B2 (en) | 2024-02-20 |
CN108271347A (zh) | 2018-07-10 |
CA2998170C (en) | 2023-10-03 |
US20170071780A1 (en) | 2017-03-16 |
JP2021058680A (ja) | 2021-04-15 |
EP3349668B1 (en) | 2023-03-29 |
EP3349668A4 (en) | 2019-08-14 |
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