JP2020062538A - 組織拡張デバイス、システムおよび方法 - Google Patents
組織拡張デバイス、システムおよび方法 Download PDFInfo
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
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- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
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Abstract
Description
本出願は、2012年4月19日出願の米国仮出願第61/635,810号(代理人整理番号第41714−705.101号)の利益を主張し、その米国仮出願の全内容は、本明細書で参照によって援用される。本出願はまた、2012年1月18日出願のPCT出願番号PCT/US2012/01739(代理人整理番号第41714−703.601号)、および2013年2月27日出願のPCT出願番号PCT/US2013/28082(代理人整理番号第41714−704.601号に関連し、各々の内容は、本明細書で参照によってそれらの全体が援用される。
(項目1)
組織を拡張するためのデバイスであって、前記デバイスは、
近位端と、遠位端と、前記近位端と前記遠位端との間の管腔とを備える少なくとも1つの流体送達管と、
前記少なくとも1つの流体送達管の管腔と流体連通している少なくとも1つの流体送達要素と
を備え、
前記デバイスは、管腔壁組織のほぼ完全な円周方向拡張を行うように構築および配置される、
デバイス。
(項目2)
前記ほぼ完全な円周方向拡張は、流体送達の単一のオペレータステップで行われる、いずれかの前記デバイスの項目に記載のデバイス。
(項目3)
前記少なくとも1つの流体送達要素は、2つまたはそれよりも多くの流体送達要素を備え、前記流体送達の単一のオペレータステップは、同時または連続的に、前記2つまたはそれよりも多くの流体送達要素からの流体送達を含む、項目2に記載のデバイス。
(項目4)
前記デバイスは、管腔壁組織によって包囲されている管腔を狭くすること、組織の中へ所定の体積の流体を送達すること、または組織の中への流体の圧力制御された送達を提供することのうちの少なくとも1つを行うように構築および配置される、いずれかの前記デバイスの項目に記載のデバイス。
(項目5)
前記管腔壁組織は、粘膜下組織を含む、いずれかの前記デバイスの項目に記載のデバイス。
(項目6)
前記少なくとも1つの流体送達要素は、同時および/または連続的に流体を送達するように構築および配置されている2つまたはそれよりも多くの流体送達要素を備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目7)
前記少なくとも1つの流体送達要素は、比較的円周方向のアレイに位置付けられている少なくとも3つの流体送達要素を備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目8)
前記少なくとも1つの流体送達要素は、少なくとも3つの流体送達要素を備え、前記少なくとも1つの流体送達管は、単一の流体送達管を備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目9)
第1の流体送達要素、第2の流体送達要素、および第3の流体送達要素に前記単一の流体送達管を動作可能に接続するように構築および配置されているマニホールドをさらに備える、項目8に記載のデバイス。
(項目10)
少なくとも1つの出口ポートをさらに備え、前記少なくとも1つの流体送達要素は、前記少なくとも1つの出口ポートから外へ動作可能に前進させられるように構築および配置される、いずれかの前記デバイスの項目に記載のデバイス。
(項目11)
前記少なくとも1つの流体送達要素は、前進可能な流体送達要素を備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目12)
前記少なくとも1つの流体送達要素の前進を制限するように位置付けられている表面をさらに備える、項目11に記載のデバイス。
(項目13)
前記少なくとも1つの流体送達要素は、固定距離を前進させられるように構築および配置される、項目11に記載のデバイス。
(項目14)
前記少なくとも1つの流体送達管を包囲し、かつ陥凹部分を備える細長いシャフトをさらに備え、前記少なくとも1つの流体送達要素は、前記細長いシャフトの陥凹部分の中へ前進するように構築および配置される、項目11に記載のデバイス。
(項目15)
ばね荷重式流体送達要素前進アセンブリをさらに備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目16)
前記ばね荷重式流体送達要素前進アセンブリは、複数の流体送達要素を前進させるように構築および配置される、項目15に記載のデバイス。
(項目17)
前記少なくとも1つの流体送達要素は、前記管腔壁組織が拡張されると横方向に移動するように構築および配置される、いずれかの前記デバイスの項目に記載のデバイス。
(項目18)
前記少なくとも1つの流体送達要素は、針を備え、前記デバイスは、陥凹を備える細長いシャフトをさらに備え、前記針は、前記細長いシャフトの陥凹内で維持されるように構築および配置される、いずれかの前記デバイスの項目に記載のデバイス。
(項目19)
前記少なくとも1つの流体送達要素を通して前記管腔壁組織に送達されるように構築および配置されている流体をさらに備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目20)
前記流体は、スクレロサント、抗炎症剤、抗微小管剤または他の***阻害剤、アルキル化剤、代謝拮抗剤、アントラサイクリン、植物アルカロイド、トポイソメラーゼ阻害剤、抗増殖剤、およびそれらの組み合わせから成る群から選択される生物活性機能等の生物活性機能を提供するように構築および配置されている流体を含む、項目19に記載のデバイス。
(項目21)
操作アセンブリをさらに備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目22)
前記操作アセンブリは、
組織、流体、または送達された流体のうちの1つまたはそれよりも多くの操作、
前記少なくとも1つの流体送達要素が組織の一部分の中へ貫入するときの組織の前記部分の運動の防止
のうちの少なくとも1つを行うように構築および配置される、項目21に記載のデバイス。
(項目23)
前記組織の拡張に先立って、その最中に、および/またはその後に圧力を監視するように構築および配置されている圧力監視アセンブリをさらに備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目24)
少なくとも1つの陥凹を備える拡張要素等の拡張要素をさらに備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目25)
前記デバイスは、少なくとも100cmの作業可能挿入長を備える、いずれかの前記デバイスの項目に記載のデバイス。
(項目26)
組織を拡張する方法であって、前記方法は、
組織拡張デバイスを提供することであって、前記組織拡張デバイスは、
近位端、遠位端、および前記近位端と前記遠位端との間の管腔を備える少なくとも1つの流体送達管と、
前記少なくとも1つの流体送達管の管腔と流体連通している少なくとも1つの流体送達要素と
を備える、ことと、
前記少なくとも1つの流体送達要素を通して第1の組織場所の中へ流体を送達することにより、管腔壁組織のほぼ完全な円周方向拡張を行うことと
を含む、方法。
(項目27)
前記第1の組織場所の中へ前記流体を送達することに先立って、前記第1の組織場所および/または前記第1の組織場所に近接する組織を操作することをさらに含む、項目26に記載の方法。
(項目28)
前記少なくとも1つの流体送達要素は、第1の流体送達要素と、第2の流体送達要素とを備え、前記流体は、前記第1の流体送達要素および前記第2の流体送達要素によって同時に送達される、項目26または項目27に記載の方法。
本発明の概念の一側面によると、組織を拡張するためのデバイスは、近位端と、遠位端と、近位端と遠位端との間の管腔とを備える、少なくとも1つの流体送達管と、少なくとも1つの流体送達管の管腔と流体連通している少なくとも1つの流体送達要素とを備え、本デバイスは、管腔壁組織のほぼ完全な円周方向拡張を行うため等に、1つ以上の組織層を拡張するように構成される。
は、針141を摺動可能に受容する。流体送達管121の遠位端は、密閉結合および/または摩擦係合界面(例えば、針141の近位外径部分と管121の遠位内径部分との間の界面)を介して等、針141の近位端に流体的および機械的に取り付けられる。この取付は、流体密閉を提供するが、それでもなお流体が針141の中へ流体送達管121を通過することを可能にする。針141は、示される前進位置まで等、開口部131である、支持アーム133の中の陥凹の中へ前進させられるように構築および配置される。針141は、傾斜先端を伴う27ゲージステンレス鋼針等の25から30ゲージの間の針を備えることができる。流体送達管121は、ステンレス鋼編組を含むポリイミドシャフト等の、編組を含む、プラスチック材料を備えるシャフト等の可撓性シャフトを備えることができる。
Claims (29)
- 組織を拡張するためのデバイスであって、前記デバイスは、
近位端と、遠位端と、自身を通る管腔とを有する細長いシャフトと、
前記細長いシャフトの前記管腔内に配置されている少なくとも1つの流体送達管であって、前記少なくとも1つの流体送達管は、近位端と、遠位端と、自身を通る管腔とを有する、少なくとも1つの流体送達管と、
前記少なくとも1つの流体送達管の管腔と流体連通している複数の中空流体送達針と、
前記複数の中空流体送達針に連結されるように構成されている可視化可能拡張流体の供給源と
を備え、
前記複数の中空流体送達針は、十二指腸の中の標的組織を拡張するのに十分な量の可視化可能拡張流体を前記可視化可能拡張流体の供給源から前記標的組織に注入することと、前記標的組織が撮像されるときに組織拡張の深度に対応する視覚画像を提供することとを行うように構成されており、
前記標的組織において可視化される前記可視化可能拡張流体の色が深いほど、前記標的組織における前記組織拡張が厚い、デバイス。 - 前記複数の針は、対称円周方向アレイに配置されている、請求項1に記載のデバイス。
- 前記対称円周方向アレイは、少なくとも3つの針を含む、請求項2に記載のデバイス。
- 前記細長いシャフトは、前記針を摺動可能に受容するように構成されている複数の細長い陥凹を有する、請求項1に記載のデバイス。
- 前記細長いシャフトは、拡張可能な支持アセンブリを備え、前記複数の細長い陥凹は、前記拡張可能な支持アセンブリ内に配置されている、請求項4に記載のデバイス。
- 前記細長いシャフトは、自身を通って前記針を前進させるように構成されている複数の支持アームを備える、請求項5に記載のデバイス。
- 前記複数の中空流体送達針は、連続的に前記流体を送達するように構成されている、請求項1に記載のデバイス。
- 前記複数の中空流体送達針は、同時に前記流体を送達するように構成されている、請求項1に記載のデバイス。
- 前記針に前記少なくとも1つの流体送達管を動作可能に接続するように構成されているマニホールドをさらに備える、請求項8に記載のデバイス。
- 前記拡張可能な支持アセンブリは、半径方向に拡張可能および/または半径方向に圧縮可能である、請求項5に記載のデバイス。
- 前記針は、粘膜組織を通って粘膜下組織の中へ貫通するが筋層組織を貫通しないように構成されている、請求項1に記載のデバイス。
- 前記細長いシャフトは、少なくとも1つの出口ポートを有し、前記針は、前記少なくとも1つの出口ポートから外へ動作可能に前進させられるように構成されている、請求項1に記載のデバイス。
- 前記針を前進させるように構成されているばね荷重式針前進アセンブリをさらに備える、請求項1に記載のデバイス。
- 前記組織の拡張に先立って、その最中に、および/またはその後に前記複数の細長い陥凹に印加される真空の圧力を監視するように構築および配置されている圧力監視アセンブリをさらに備える、請求項4に記載のデバイス。
- 複数の支持アームをさらに備え、前記支持アームの各々は、中空であり、側面開口部を有し、前記複数の中空流体送達針のうちの少なくとも1つを自身の中に摺動可能に受容するように構成されている、請求項1に記載のデバイス。
- 前記針は、前記支持アーム内の前記開口部を通って半径方向外向きに組織の中へ前進させられるように構成されている、請求項15に記載のデバイス。
- 前記複数の支持アームは、半径方向に拡張可能なアセンブリとして配置されている、請求項16に記載のデバイス。
- 前記中空支持アームは、組織が前記開口部を通って内向きに引き込まれ得るように陰圧源に接続されるように構成されている、請求項16に記載のデバイス。
- 組織と接触し組織を操作するように構成されている操作アセンブリをさらに備え、
前記操作アセンブリは、プローブと、前記プローブに接続される真空源とを備え、
前記プローブの遠位端は、真空ポートを備え、
前記プローブの前記遠位端は、前記組織の一部分と接触しており、
前記真空源は、前記組織の前記一部分を引き込むことにより前記プローブの前記真空ポートと前記組織の前記一部分との間の接触を維持するように前記プローブの前記真空ポートに真空を印加するように構成されており、
前記真空源が前記真空を印加するように構成された後において、前記組織の前記一部分への力の印加は、前記組織の前記一部分の移動を生じさせる、請求項1に記載のデバイス。 - 前記操作アセンブリは、少なくとも1つの真空ポートを備える、請求項19に記載のデバイス。
- 前記操作アセンブリは、少なくとも2つの真空ポートを備える、請求項20に記載のデバイス。
- 前記操作アセンブリは、前記組織の中へ以前に送達された前記可視化可能流体を移動させるように構成されている、請求項19に記載のデバイス。
- 前記操作アセンブリは、前記複数の中空流体送達針のうちの少なくとも1つに向かって前記組織を移動させるように構成されている、請求項19に記載のデバイス。
- 前記操作アセンブリは、前記組織の中へ送達されている流体の流動を指向するように構成されている、請求項19に記載のデバイス。
- 前記可視化可能流体は、メチレンブルー、染料、放射線不透過性流体、MR可視化可能流体、超音波で可視化可能な流体、およびそれらの組み合わせから成る群より選択される材料を含む、請求項1に記載のデバイス。
- 前記可視化可能流体は、可視化デバイスによって可視化されるように選択される、請求項1に記載のデバイス。
- 前記可視化デバイスは、内視鏡カメラを含む、請求項26に記載のデバイス。
- 前記可視化デバイスは、可視光カメラ、OCTデバイス、OCDRデバイス、共焦点内視顕微鏡、内視鏡と一体であるかまたは内視鏡を通して挿入される撮像デバイス、フルオロスコープ、CTスキャナ、MRスキャナ、超音波撮像装置、患者に挿入される撮像デバイス、およびそれらの組み合わせからなる群より選択されるデバイスを含む、請求項26に記載のデバイス。
- 前記可視化デバイスは、前記デバイス内に一体化される撮像アセンブリを含む、請求項26に記載のデバイス。
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IL234948A0 (en) | 2014-12-31 |
KR102231179B1 (ko) | 2021-03-22 |
EP3711810A1 (en) | 2020-09-23 |
JP2015516859A (ja) | 2015-06-18 |
US20150045825A1 (en) | 2015-02-12 |
JP6654228B2 (ja) | 2020-02-26 |
JP7054400B2 (ja) | 2022-04-13 |
AU2013249043A1 (en) | 2014-10-30 |
US20170007324A1 (en) | 2017-01-12 |
KR20140147118A (ko) | 2014-12-29 |
CA2869904C (en) | 2020-04-21 |
EP4218884A2 (en) | 2023-08-02 |
US20220354571A1 (en) | 2022-11-10 |
CA2869904A1 (en) | 2013-10-24 |
US10765474B2 (en) | 2020-09-08 |
IL234948B (en) | 2021-03-25 |
EP4218884A3 (en) | 2023-09-13 |
JP2018202207A (ja) | 2018-12-27 |
WO2013159066A1 (en) | 2013-10-24 |
JP6409111B2 (ja) | 2018-10-17 |
JP2018029996A (ja) | 2018-03-01 |
JP6235559B2 (ja) | 2017-11-22 |
EP2838598A1 (en) | 2015-02-25 |
EP2838598B1 (en) | 2020-01-15 |
EP2838598A4 (en) | 2015-12-23 |
AU2013249043B2 (en) | 2017-04-27 |
EP3711810B1 (en) | 2023-02-22 |
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