JP2017164572A - 組織の治療のための熱切除システム、デバイスおよび方法 - Google Patents
組織の治療のための熱切除システム、デバイスおよび方法 Download PDFInfo
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Abstract
【解決手段】標的組織の治療のためのシステムは、切除デバイスと、エネルギー送達ユニットとを備える。切除デバイスは、拡張可能治療要素を伴う伸長管を備える。本システムは、標的組織を治療するように、エネルギーの熱用量を送達する。標的組織を治療する方法も提供される。標的組織を治療するためのシステムは、切除デバイスであって、切除デバイスは、近位部分、遠位部分、および近位部分から遠位部分まで延在する管腔を伴う伸長管と、伸長管に搭載され、管腔と流体連通している拡張可能治療要素と、を備える、切除デバイスと、エネルギーを拡張可能治療要素に送達するように構築および配列されたエネルギー送達ユニットとを備え、システムは、エネルギーの熱用量を標的組織に送達するように構築および配列されている。
【選択図】図1
Description
本出願は、2012年2月27日に出願された米国仮出願第61/603,475号(Attorney Docket No.41714−704.101)に対して優先権を主張する。上記文献の開示内容の全ては、参照することによって本明細書において援用される。
本明細書に開示される実施形態は、概して、組織、特に、胃腸組織を治療するためのシステム、デバイス、および方法に関する。
糖尿病は、人体が、十分なインスリンを産生しないため、または身体の細胞が、産生されたインスリンに効果的に応答不可能であるため、高血糖を発症するヒトにおける、代謝性疾患である。主に、糖尿病は、1型および2型の2つのタイプがある。1型糖尿病は、膵臓ベータ細胞の身体自己免疫破壊により、身体が十分なインスリンを産生できないため生じる。一方で、2型糖尿病は、インスリン抵抗(身体の細胞が、産生されたインスリンを適切に利用することができない)および身体の必要性を満たすためには不適正なインスリン産生を通して、高血糖症を生じさせる、複合代謝性障害である。
(項目1)
標的組織を治療するためのシステムであって、前記システムは、
切除デバイスであって、前記切除デバイスは、
近位部分、遠位部分、および前記近位部分から前記遠位部分まで延在する管腔を有する伸長管と、
前記伸長管に搭載され、前記管腔と流体連通している拡張可能治療要素と、
を備える、切除デバイスと、
エネルギーを前記拡張可能治療要素に送達するように構築および配列されたエネルギー送達ユニットと
を備え、
前記システムは、エネルギーの熱用量を前記標的組織に送達するように構築および配列されている、システム。
(項目2)
前記熱用量は、前記治療要素の材料の熱伝達性質、前記標的組織の熱伝達性質、前記治療要素と前記標的組織との間の界面における熱伝達係数、およびそれらの組み合わせから成る群から選択されるパラメータに基づく、項目1に記載のシステム。
(項目3)
アルゴリズムをさらに備え、前記熱用量は、前記アルゴリズムによって決定される、項目1〜2のいずれかに記載のシステム。
(項目4)
前記アルゴリズムは、患者測定データに基づく、項目3に記載のシステム。
(項目5)
前記システムはさらに、較正ルーチンを行うように構築および配列され、前記患者測定データは、前記較正ルーチンの実施中に収集される、項目4に記載のシステム。
(項目6)
前記システムはさらに、較正ルーチンを行うように構築および配列され、前記アルゴリズムは、前記較正ルーチン中に収集されるデータに基づく、項目3に記載のシステム。
(項目7)
前記熱用量は、前記治療要素に送達される加熱流体の単回ボーラスによって送達される、前記エネルギーを含む、項目1〜6のいずれかに記載のシステム。
(項目8)
前記単回ボーラスは、加熱流体の固定質量を含む、項目7に記載のシステム。
(項目9)
前記システムは、ある圧力または圧力の範囲で前記単回ボーラスを維持するように構築および配列されている、項目7に記載のシステム。
(項目10)
前記システムは、前記治療要素の圧力および/または直径に基づいて、前記単回ボーラスを送達するように構築および配列されている、項目7に記載のシステム。
(項目11)
前記熱用量は、一連の単回ボーラス加熱流体送達を含む、項目1〜10のいずれかに記載のシステム。
(項目12)
前記熱用量は、前記治療要素を通して加熱流体を循環させることによって送達される、項目1〜11のいずれかに記載のシステム。
(項目13)
前記加熱流体は、前記治療要素の中、上、および/または付近に比較的一定の温度で維持される、項目12に記載のシステム。
(項目14)
前記加熱流体は、65℃から99℃の間の温度で維持される、項目13に記載のシステム。
(項目15)
前記加熱流体は、水、生理食塩水、パーフッ素化化合物、およびそれらの組み合わせから成る群から選択される、項目13に記載のシステム。
(項目16)
前記熱用量は、エネルギー送達の固定持続時間を含む、項目1〜15のいずれかに記載のシステム。
(項目17)
前記熱用量は、エネルギーの連続的時変送達を含む、項目1〜16のいずれかに記載のシステム。
(項目18)
前記エネルギーの連続的時変送達は、前記治療要素を通して高温流体を再循環させることによって提供される、項目17に記載のシステム。
(項目19)
前記熱用量は、準定常状態温度プロファイルを有する、エネルギーの送達を含む、項目1〜18のいずれかに記載のシステム。
(項目20)
前記熱用量は、ある期間にわたる時間平均温度制御に基づくエネルギー送達を含む、項目1〜19のいずれかに記載のシステム。
(項目21)
前記熱用量は、比較的一定の温度でのエネルギー送達を含む、項目1〜20のいずれかに記載のシステム。
(項目22)
前記エネルギーは、65℃から99℃の間の温度の流体から送達される、項目21に記載のシステム。
(項目23)
前記エネルギーは、約30秒から60秒にわたって、約65℃の温度の流体から送達される、項目21に記載のシステム。
(項目24)
前記エネルギーは、約5秒から45秒にわたって、約70℃の温度の流体から送達される、項目21に記載のシステム。
(項目25)
前記エネルギーは、約3秒から40秒にわたって、約75℃の温度の流体から送達される、項目21に記載のシステム。
(項目26)
前記エネルギーは、約3秒から30秒にわたって、約80℃の温度の流体から送達される、項目21に記載のシステム。
(項目27)
前記エネルギーは、約3秒から20秒にわたって、約90℃の温度の流体から送達される、項目21に記載のシステム。
(項目28)
前記システムは、エネルギーの複数の熱用量を前記標的組織に送達するように構築および配列されている、項目1〜27のいずれかに記載のシステム。
(項目29)
第1の用量は、第1の組織場所に送達され、第2の用量は、前記第1の組織場所に送達される、項目28に記載のシステム。
(項目30)
第1の用量は、第1の組織場所に送達され、第2の用量は、第2の組織場所に送達される、項目28に記載のシステム。
(項目31)
前記システムは、切除パラメータを測定し、前記測定に基づいて前記熱用量を調整するように構築および配列されている、項目1〜30のいずれかに記載のシステム。
(項目32)
前記システムは、前記治療要素の中の高温流体の前記温度を測定するように構築および配列されている、項目31に記載のシステム。
(項目33)
前記システムは、較正手順を行って温度減衰をモデル化するように構築および配列されている、項目31に記載のシステム。
(項目34)
前記システムはさらに、較正ルーチンを行うように構築および配列されている、項目1〜33のいずれかに記載のシステム。
(項目35)
前記較正ルーチンは、較正ボーラスの送達を含む、項目34に記載のシステム。
(項目36)
前記較正ルーチンは、前記治療要素への流体の送達を含み、前記流体は、組織切除を引き起こすレベルを下回る温度の流体を含む、項目34に記載のシステム。
(項目37)
前記システムはさらに、前記標的組織に存在する残留熱を監視するように構築および配列されている、項目1〜36のいずれかに記載のシステム。
(項目38)
流入ポートと、流出ポートとをさらに備え、前記流入ポートおよび流出ポートは、前記治療要素と流体連通している、項目1〜37のいずれかに記載のシステム。
(項目39)
前記システムは、前記熱用量温度が、修正された標的温度への変更を開始して15秒以内に前記修正された標的温度の90%に達するような熱応答時間を有する、項目1〜38のいずれかに記載のシステム。
(項目40)
前記熱用量は、十二指腸漿膜への損傷を回避しながら、十二指腸粘膜を切除するように構築および配列されている、項目1〜39のいずれかに記載のシステム。
(項目41)
前記熱用量は、非標的組織への損傷を回避しながら、標的組織を切除するように構築および配列されている、項目1〜40のいずれかに記載のシステム。
(項目42)
前記拡張可能治療要素は、バルーンを備える、項目1〜41のいずれかに記載のシステム。
(項目43)
前記バルーンは、柔軟バルーンを備える、項目42に記載のシステム。
(項目44)
前記バルーンは、非柔軟バルーンを備える、項目42に記載のシステム。
(項目45)
前記拡張可能治療要素は、複数のバルーンを備える、項目1〜44のいずれかに記載のシステム。
(項目46)
前記拡張可能治療要素は、閾値圧力を上回る加圧後に、最初に拡張するように構築および配列されている、項目1〜45のいずれかに記載のシステム。
(項目47)
前記システムはさらに、前記拡張可能治療要素を熱的に準備するように構築および配列されている、項目1〜46のいずれかに記載のシステム。
(項目48)
前記システムはさらに、前記拡張可能治療要素を急速に膨張させるように構築および配列されている、項目1〜47のいずれかに記載のシステム。
(項目49)
前記システムは、前記治療要素から離して前記標的組織を移動させ、前記標的組織へのエネルギーの送達を停止するように構築および配列されている、項目1〜48のいずれかに記載のシステム。
(項目50)
前記システムは、前記治療要素に向かって前記標的組織を移動させ、前記標的組織へのエネルギーの送達を開始するように構築および配列されている、項目1〜49のいずれかに記載のシステム。
(項目51)
前記拡張可能治療要素は、透過性である少なくとも一部分を備える、項目1〜50のいずれかに記載のシステム。
(項目52)
前記伸長管の近位部分から前記伸長管の遠位部分まで延在する第2の管腔をさらに備え、前記第2の管腔は、前記拡張可能治療要素と流体連通している、項目1〜51のいずれかに記載のシステム。
(項目53)
近位部分、遠位部分、および前記近位部分から前記遠位部分まで延在する管腔を有する第2の伸長管をさらに備える、項目1〜52のいずれかに記載のシステム。
(項目54)
前記伸長管、前記伸長管の前記管腔、および前記治療要素のうちの少なくとも1つの圧潰を防止するように構築および配列された半径方向支持構造をさらに備える、項目1〜53のいずれかに記載のシステム。
(項目55)
前記エネルギー送達ユニットは、流体加熱器を備える、項目1〜54のいずれかに記載のシステム。
(項目56)
前記エネルギー送達ユニットは、流体ポンプを備える、項目1〜55のいずれかに記載のシステム。
(項目57)
センサをさらに備える、項目1〜56のいずれかに記載のシステム。
(項目58)
前記熱用量の送達を修正するように構築および配列されたコントローラをさらに備える、項目1〜57のいずれかに記載のシステム。
(項目59)
前記拡張可能治療要素内で流体混合を引き起こすように構築および配列された流体混合アセンブリをさらに備える、項目1〜58のいずれかに記載のシステム。
(項目60)
前記システムはさらに、陰圧プライミングアセンブリを備える、項目1〜59のいずれかに記載のシステム。
(項目61)
前記拡張可能治療要素を縦方向に位置付けるように構築および配列された運動伝達要素をさらに備える、項目1〜60のいずれかに記載のシステム。
(項目62)
第2の治療要素をさらに備える、項目1〜61のいずれかに記載のシステム。
(項目63)
標的組織を治療する方法であって、
拡張可能治療要素を備える切除デバイスを提供することと、
前記拡張可能治療要素から標的組織へエネルギーを送達することによって、熱用量を前記標的組織に送達することと
を含み、
前記熱用量は、
前記治療要素と前記標的組織との間の並置を調整することによって決定されるエネルギーの量、
前記治療要素に接触する前記標的組織の直径を縮小することによって開始される熱用量、
流体の単回ボーラスによって送達されるエネルギーの量、
ある持続時間にわたって所定の温度で維持される流体によって送達されるエネルギーの量、
所定の持続時間にわたって所定の温度で維持される流体によって送達されるエネルギーの量、
および、
プライミング手順が行われた後に送達される熱用量
のうちの1つ以上を含む、方法。
(項目64)
標的組織を治療するための方法であって、
小腸に治療デバイスのバルーンを挿入することと、
加熱流体で前記バルーンを膨張させることと、
切除熱用量を前記標的組織に送達することと、
送達される流体の温度、圧力、および/または流速を測定および制御することと、
膨張サイクル内または間の時間の関数として、温度、流速、および/または他のパラメータを測定することと、
治療の進行を評価し、必要に応じて調整を行うように、解釈アルゴリズムを収集されたデータに適用することと、
1つまたはいくつかの膨張サイクルの間に、腸の所望の部分の腸粘膜の実質的に全体の切除を達成するために十分な期間にわたって、前記膨張したバルーンを前記腸粘膜と接触させて維持することと
を含む、方法。
(要約)
本発明の概念の一側面によると、標的組織を治療するためのシステムは、切除デバイスと、エネルギー送達ユニットとを備える。切除デバイスは、近位部分、遠位部分、および近位部分から遠位部分まで延在する管腔を有する伸長管を備える。切除デバイスはさらに、伸長管に搭載され、管腔と流体連通している、拡張可能治療要素を備える。エネルギー送達ユニットは、エネルギーを治療要素に送達するように構築および配列される。本システムは、エネルギーの熱用量を標的組織に送達するように構築および配列される。
ここで、本発明の概念の本実施形態を詳細に参照し、その実施例は、添付図面に図示されている。実用的であるときはいつでも、同一の参照番号が、図面の全体を通して、同一または類似部品を指すために使用されるであろう。
デバイスおよび方法の好ましい実施形態が、それらが開発された環境を参照して説明されているが、それらは、単に、本発明の原理の例証である。本発明を実行するための前述のアセンブリ、他の実施形態、構成、および方法の修正または組み合わせ、ならびに当業者に明白である、本発明の概念の側面の変形例は、請求項の範囲内であると意図される。加えて、本願は、方法または手順のステップを特異的順序で列挙しているが、いくつかのステップが実施される順序を変更することが可能であって、ある状況では、好都合でさえあり得、以下に記載の方法または手順請求項の特定のステップは、そのような順序の特異性が、請求項に明示的に記載されない限り、順序が特異的であると解釈されないことが意図される。
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EP2819601B1 (en) | 2022-04-06 |
AU2018200371B2 (en) | 2020-01-30 |
KR102086184B1 (ko) | 2020-03-06 |
EP4066764A1 (en) | 2022-10-05 |
JP6434088B2 (ja) | 2018-12-05 |
US11419659B2 (en) | 2022-08-23 |
AU2018200371A1 (en) | 2018-02-08 |
US20230172649A1 (en) | 2023-06-08 |
CA2865567A1 (en) | 2013-09-06 |
JP2015508015A (ja) | 2015-03-16 |
CA2865567C (en) | 2022-10-11 |
KR20140135220A (ko) | 2014-11-25 |
US20200138505A1 (en) | 2020-05-07 |
JP6863949B2 (ja) | 2021-04-21 |
IL296643A (en) | 2022-11-01 |
AU2020202563A1 (en) | 2020-05-07 |
IL277492A (en) | 2020-11-30 |
JP6167115B2 (ja) | 2017-07-19 |
IL234333B (en) | 2020-10-29 |
AU2013226062B2 (en) | 2017-10-19 |
EP2819601A4 (en) | 2015-09-02 |
EP2819601A1 (en) | 2015-01-07 |
AU2013226062A1 (en) | 2014-09-18 |
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