JP2012501754A - 複数の腸内瘻孔処置用拡張可能デバイス - Google Patents
複数の腸内瘻孔処置用拡張可能デバイス Download PDFInfo
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- JP2012501754A JP2012501754A JP2011526248A JP2011526248A JP2012501754A JP 2012501754 A JP2012501754 A JP 2012501754A JP 2011526248 A JP2011526248 A JP 2011526248A JP 2011526248 A JP2011526248 A JP 2011526248A JP 2012501754 A JP2012501754 A JP 2012501754A
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Abstract
Description
本願は、米国仮特許出願第61/094,378号(2008年9月4日出願)の米国特許法第119条第(e)項の優先権の利益を主張し、この出願の開示は、その全体が本明細書に参考として援用される。
本発明は、医療器具および方法に関する。より具体的には、本発明は、瘻孔を閉鎖するための埋め込み型デバイスと、このようなデバイスを使用する方法とに関する。
本方法は、少なくとも2つの生体吸収性構造を充填デバイスから押圧するステップ、および/または閉塞部材を拡張するステップをさらに含み得る。閉塞部材を拡張するステップは、閉塞部材の第1の寸法を減少させるステップとともに、第1の寸法に対して横断方向の閉塞部材の第2の寸法を増加させるステップを含み得る。第1の寸法は、閉塞部材の長手方向の長さであり得る。閉塞部材を拡張するステップは、第1の寸法に沿った閉塞部材の大きさの少なくとも4倍以上の大きさに、第2の寸法に沿って閉塞部材を拡張するステップを含み得、第2の寸法は、第1の寸法に対して横断方向である。閉塞部材は、少なくとも2cm以上の大きさに第2の寸法に沿って拡張され得る。閉塞部材を挿入するステップは、組織管を生体吸収性材料で充填するステップの前に発生し得る。本方法は、組織管を排気するステップをさらに含み得る。本方法は、気体流入に抵抗するために、排気された組織管を封止するステップをさらに含み得、組織管の圧力を、周囲圧力から、約100mmHg〜約325mmHgだけ低下させるステップを含み得る。体内空間は、胃腸管腔の一部分である。胃腸管腔のその部分は、Trietz靭帯に対して遠位に、かつ直腸に対して近位に位置し得る。横断表面は、皮膚表面であり得る。本方法は、ファイバスコープを使用して、閉塞部材の挿入を直接視覚化するステップをさらに含み得る。閉塞部材を組織管に挿入するステップは、可撓性カテーテルを使用して実行され得る。組織管を閉塞するステップは、閉塞部材のテザーに張力をかけるステップを含み得る。また、本方法は、組織管を第1の生体吸収性材料で充填するステップの前に、組織管を創傷清拭するステップもさらに含み得る。
図3A〜図3Cから理解できるように、特徴50は、側方方向に拡張し、これは、腸管腔におけるデバイス5の遠位部分のプロファイルを低下させるという点において有利であり得る。デバイス本体13は、上述のように、残りの瘻管10を充填するように拡張する。張力が、デバイス5上にかけられ得、これにより、拡張特徴50は、瘻管10の遠位端に対して閉塞する。張力によって、存在する場合、タイン45が、管の遠位開口部12の表面に、より確実に係合する。
別の実施形態では、特徴50は、拡張状態に付勢され、機構を動作することによって、円板90を相互から離隔して押し進め、デバイス5が管10を通り抜けている際に、特徴50が、図4Aに示す2重円筒状構成を呈するようにする。特徴50が管開口部12を通過すると、機構は、特徴50が、図4Bに示す拡張状態に付勢可能になるように解放され得る。次いで、特徴50は、管開口部12のアンカーおよび/または封止としての役割を果たし得る。デバイス本体13は、概して、上述のように、残りの瘻管10を充填するように拡張する。
Claims (70)
- 腸管皮膚瘻を処置する方法であって、
第1および第2の生体吸収性テザーに取り付けられた拡張可能な円板を腸管皮膚瘻管の中に挿入することであって、該円板は折り畳み構成にある、ことと、
該拡張可能な円板を該腸管皮膚瘻管の遠位管開口部に対して遠位に配置することと、
該拡張可能な円板を該折り畳み構成から拡張構成に拡張することと、
該拡張可能な円板に取り付けられた該第1のテザーに張力をかけることによって、該拡張可能な円板を該遠位管開口部に一致させる、ことと、
該第2のテザーを使用して、複数の細長い生体吸収性発泡体拡張部材によって該瘻管を充填することと、
該腸管皮膚瘻管の近位管開口部を横切って近位アンカーを該テザーに固定することによって該第1および第2のテザーを張力がかけられた状態に拘束し、それにより、該拡張可能な円板を該遠位管開口部に対して維持することと
を含む、方法。 - 前記拡張可能な円板は、環状部材および複数の半径方向部材を備える、請求項1に記載の方法。
- 前記第2のテザーを前記複数の細長い生体吸収性発泡体拡張部材に取り付けられたループに通すことをさらに含む、請求項1に記載の方法。
- 前記瘻管内の圧力を低下させるために、前記近位アンカーを介して吸引力を印加することをさらに含む、請求項1に記載の方法。
- 陰圧を使用して、前記拡張可能な円板を前記折り畳み構成に折り畳むことをさらに含む、請求項1に記載の方法。
- 前記拡張可能な円板を拡張することは、該拡張可能な円板を膨張させることを含む、請求項1に記載の方法。
- 吸引管腔を含む拡張可能な円板と、
該円板に結合された第1および第2のテザーと、
該拡張可能な円板の該吸引管腔に結合するように構成されたカテーテルと、
腸管皮膚瘻に挿入するように構成された複数の細長い生体吸収性発泡拡張部材と、
該第1および第2のテザーへの摺動可能な結合を可能にする少なくとも1つのアパーチャ、および該腸管皮膚瘻内への通過に抵抗するように構成された組織接触表面を含む近位アンカーと
を備える、瘻孔処置キット。 - 少なくとも1つの細長い生体吸収性発泡体拡張部材は、前記第2のテザーに摺動可能に結合するように構成されたループを備える、請求項7に記載のキット。
- 前記近位アンカーは、少なくとも1つの吸引チャネルを備える、請求項7に記載のキット。
- 組織管を処置する方法であって、
非吸収性の拡張可能部材を体内管腔と連通する組織管に挿入することと、
該拡張可能部材を拡張することと、
該拡張可能部材に取り付けられた第1のテザーに張力をかけることと、
生体吸収性材料を瘻管内に留置することと、
該第1のテザーを張力がかけられた状態に拘束することと
を含む、方法。 - 前記非吸収性部材を折り畳むことをさらに含む、請求項10に記載の方法。
- 前記非吸収性部材を折り畳むことは、陰圧を使用して実行される、請求項11に記載の方法。
- 前記拡張可能部材を前記組織管と前記体内管腔との間の接合部に一致させることをさらに含む、請求項12に記載の方法。
- 前記組織管は、腸管皮膚瘻管、腸管経腸瘻管、または胃−胃瘻孔である、請求項13に記載の方法。
- 前記第1のテザーを張力がかけられた状態に拘束することは、近位アンカーを該第1のテザーに取り付けることを含み、該近位アンカーは、組織表面に対して位置する、請求項10に記載の方法。
- 前記近位アンカーの吸引チャネルを使用して、陰圧を前記組織管に印加することをさらに含む、請求項15に記載の方法。
- 前記組織管の少なくとも一部分を前記拡張可能部材によって封止することをさらに含む、請求項10に記載の方法。
- 前記生体吸収性材料は、少なくとも1つの発泡体構造を備える、請求項10に記載の方法。
- 前記生体吸収性材料を前記組織管内に留置することは、少なくとも1つの発泡体構造を第2のテザーに沿って摺動させることを含む、請求項10に記載の方法。
- 少なくとも1つの発泡体構造を摺動させることは、少なくとも1つの発泡体構造に取り付けられたループを使用して実行される、請求項19に記載の方法。
- 前記第2のテザーを使用して前記ループを通すことをさらに含む、請求項20に記載の方法。
- 吸引管腔およびテザー取り付け構造を備える折り畳み可能部材であって、体内管腔内に配置するように構成される、折り畳み可能部材と、
該折り畳み可能部材に取り付けられたテザーと、
非血管性瘻管に留置するように構成された生体吸収性材料と
を備える、非血管性瘻孔処置キット。 - 吸引チャネルを含む送達ツールをさらに備え、該送達ツールは、前記折り畳み可能部材に着脱可能に結合するように構成される、請求項22に記載のキット。
- 前記生体吸収性材料は、複数の発泡体部材を備え、各発泡体部材は、第1の端部、第2の端部、およびそれらの間の本体を備える、請求項22に記載のキット。
- 各発泡体部材は、細長い発泡体部材である、請求項24に記載のキット。
- 前記複数の発泡体部材は、ループ状端部構造を備える可撓性要素を使用して取り付けられる、請求項25に記載のキット。
- 前記テザーに取り付け可能であり、組織接触表面を備える、近位アンカーをさらに備える、請求項23に記載のキット。
- 前記送達ツールの挿入を可能にするように構成された送達カニューレをさらに備える、請求項23に記載のキット。
- 前記テザーに結合するように構成される近位アンカーをさらに備える、請求項23に記載のキット。
- 腸管腔内に送達するように構成され、テザー取り付け構造および弓状部材を備える拡張可能部材と、
該拡張可能部材に取り付けられたテザーと
を備える、非血管性瘻孔処置キット。 - 前記拡張可能部材は、円板状の面を有する、請求項31に記載のキット。
- 前記弓状部材は、弓状チャネルである、請求項31に記載のキット。
- 前記拡張可能部材は、少なくとも1つの半径方向部材をさらに備える、請求項31に記載のキット。
- 前記弓状部材は、弓状チャネルであり、前記少なくとも1つの半径方向部材は、少なくとも1つの半径方向チャネルである、請求項34に記載のキット。
- 前記弓状チャネルは、弓状管腔であり、前記少なくとも1つの半径方向チャネルは、少なくとも1つの半径方向管腔である、請求項35に記載のキット。
- 前記テザーに固定的に取り付け可能であり、組織接触表面を備える近位アンカーをさらに備える、請求項31に記載のキット。
- 前記拡張可能部材に解放可能に取り付け可能な送達カテーテルをさらに備える、請求項31に記載のキット。
- カニューレに位置する複数の吸収性部材をさらに備える、請求項31に記載のキット。
- 前記カニューレに挿入するように構成されたカニューレ押圧部材をさらに備える、請求項39に記載のキット。
- 前記複数の吸収性部材は、連続的に取り付けられる、請求項39に記載のキット。
- 前記複数の吸収性部材のうちの少なくとも1つは、ループ構造に取り付けられる、請求項39に記載のキット。
- 瘻孔を処置する方法であって、
少なくとも1つのテザーに取り付けられた拡張可能な閉塞具を、その折り畳み状態で、組織管を通して、体内管腔に向かって、管状部材を使用して挿入することであって、該円板閉塞具は非吸収性である、ことと、
該体内管腔の表面に対して該拡張可能な閉塞具を一致させるために、少なくとも1つのテザーに張力をかけることと、
該管状部材を該拡張可能な閉塞具から分離することと、
該管状部材を該組織管から取り外すことと、
複数の生体吸収性拡張部材を該組織管内に埋め込むことであって、該生体吸収性拡張部材のうちの少なくとも1つは、少なくとも1つのテザーに結合される、ことと、
該体内管腔の表面とは異なる組織表面に対して位置する近位アンカーに少なくとも1つのテザーを固定することによって、少なくとも1つのテザーを張力がかけられた状態に拘束することと
を含む、方法。 - 前記複数の生体吸収性拡張部材は、相互に連結される、請求項43に記載の方法。
- 少なくとも4つの相互に連結された細長い生体吸収性拡張部材を含む少なくとも1つのチューブと、
該チューブから外に該拡張部材を押圧するように構成された押圧部材と、
実質的に非弾性であるポリマー材料を備える拡張可能な閉塞部材と
を備える、瘻孔処置キット。 - 少なくとも2つのチューブをさらに備え、各々は、少なくとも4つの相互に連結された拡張部材を含む、請求項45に記載の瘻孔処置キット。
- 組織管を処置する方法であって、
解剖学的な体内空間に向かって閉塞部材を組織管に挿入することと、
該体内空間の表面に対して該閉塞部材を適用することによって、該組織管を閉塞することと、
該第1の生体吸収性材料を該挿入された閉塞部材に事前結合せずに、該組織管を第1の生体吸収性材料によって充填することと
を含む、方法。 - 前記組織管を横断する表面に対して前記閉塞部材を固定することによって、前記体内空間の前記表面に対して、該閉塞部材を拘束することをさらに含む、請求項47に記載の方法。
- 前記閉塞部材と前記組織管の壁との間に充填デバイスを配置することをさらに含む、請求項47に記載の方法。
- 前記第1の生体吸収性材料は、複数の相互に連結された生体吸収性構造を備える、請求項49に記載の方法。
- 少なくとも2つの生体吸収性構造を前記充填デバイスから外に押圧することをさらに含む、請求項45に記載の方法。
- 前記閉塞部材を拡張することをさらに含む、請求項47に記載の方法。
- 前記閉塞部材を拡張することは、該閉塞部材の第1の寸法を減少させることとともに、該第1の寸法に対して横断方向の該閉塞部材の第2の寸法を増加させることを含む、請求項52に記載の方法。
- 前記第1の寸法は、前記閉塞部材の長手方向の長さである、請求項53に記載の方法。
- 前記閉塞部材を拡張することは、第1の寸法に沿う該閉塞部材の大きさの少なくとも4倍以上の大きさに、第2の寸法に沿って該閉塞部材を拡張することを含み、該第2の寸法は、該第1の寸法に対して横断方向である、請求項47に記載の方法。
- 前記閉塞部材は、少なくとも2cm以上の大きさに前記第2の寸法に沿って拡張される、請求項55に記載の方法。
- 前記閉塞部材を挿入することは、前記組織管を前記生体吸収性材料によって充填することの前に生じる、請求項47に記載の方法。
- 前記組織管を排気することをさらに含む、請求項47に記載の方法。
- 気体流入に抵抗するために、前記排気された組織管を封止することをさらに含む、請求項58に記載の方法。
- 前記組織管の圧力を、周囲圧力から約100mmHg〜約325mmHgだけ低下させることをさらに含む、請求項58に記載の方法。
- 前記体内空間は、胃腸管腔の部分である、請求項47に記載の方法。
- 前記胃腸管腔の部分は、Trietz靭帯に対して遠位に、直腸に対して近位に位置する、請求項61に記載の方法。
- 前記横断表面は、皮膚表面である、請求項48に記載の方法。
- ファイバスコープを使用して、前記閉塞部材の挿入を直接視覚化することをさらに含む、請求項47に記載の方法。
- 前記閉塞部材を前記組織管に挿入することは、可撓性カテーテルを使用して実行される、請求項47に記載の方法。
- 前記組織管を閉塞することは、前記閉塞部材のテザーに張力をかけることを含む、請求項47に記載の方法。
- 前記組織管を第1の生体吸収性材料によって充填することの前に、該組織管を創傷清拭することをさらに含む、請求項47に記載の方法。
- アンカー取り付け部を備え、第1の断面積を含む送達構成と、該第1の断面積を上回る第2の断面積を含む配備構成とを有する拡張可能な遠位アンカーと、
アンカーテザーと、
該拡張可能な遠位アンカーおよび該アンカーテザーを送達可能に保持するように構成される第1の送達チューブと、
第2の送達チューブに位置する複数の拡張可能な充填構造と
を備える、組織管処置システム。 - 前記拡張可能な充填構造は、細長いポリマー部材を備える、請求項68に記載のシステム。
- 前記細長いポリマー部材は、圧縮された細長いポリマー部材である、請求項68に記載のシステム。
- 前記複数の拡張可能な充填構造は、相互に連結される、請求項68に記載のシステム。
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JP2019514492A (ja) * | 2016-04-21 | 2019-06-06 | ケンブリッジ ユニヴァーシティー ホスピタルズ エヌエイチエス ファウンデーション トラスト | 体内の欠陥の治療用装置 |
JP7114483B2 (ja) | 2016-04-21 | 2022-08-08 | ケンブリッジ ユニヴァーシティー ホスピタルズ エヌエイチエス ファウンデーション トラスト | 体内の欠陥の治療用装置 |
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US20100249827A1 (en) | 2010-09-30 |
US8206416B2 (en) | 2012-06-26 |
US20100249828A1 (en) | 2010-09-30 |
US9993235B2 (en) | 2018-06-12 |
CN102202582B (zh) | 2014-07-30 |
CA2735748A1 (en) | 2010-03-11 |
JP5787405B2 (ja) | 2015-09-30 |
US8177809B2 (en) | 2012-05-15 |
US8377094B2 (en) | 2013-02-19 |
WO2010028300A1 (en) | 2010-03-11 |
WO2010028300A8 (en) | 2010-07-08 |
EP2330985A1 (en) | 2011-06-15 |
CN102202582A (zh) | 2011-09-28 |
AU2009289474A1 (en) | 2010-03-11 |
AU2009289474B2 (en) | 2015-09-03 |
CA2735748C (en) | 2017-08-29 |
US20120016412A1 (en) | 2012-01-19 |
US8221451B2 (en) | 2012-07-17 |
US20130158595A1 (en) | 2013-06-20 |
US20100228184A1 (en) | 2010-09-09 |
EP2330985A4 (en) | 2015-11-18 |
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