JP2018079393A - 組織の治療のためのデバイスおよび方法 - Google Patents
組織の治療のためのデバイスおよび方法 Download PDFInfo
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Abstract
【解決手段】本システムは、遠位部分を有する細長管を含む。治療要素が細長管遠位部分上に配置され、治療要素は、標的組織を治療するように構築および配列される。一実施形態では、胃腸組織が糖尿病の治療のために修正される。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。糖尿病を治療する方法もまた、開示される。
【選択図】図4
Description
本願は、先の米国仮特許出願第61/434,319号(名称「Method and System for Treatment of Diabetes」、2011年1月19日出願、代理人整理番号41714−703.101)の利益を主張し、この出願の全内容はその全体が参照することにより本明細書に援用され、および/または、先の米国仮特許出願第61/538,601号(名称「Devices and Methods for the Treatment of Tissue」、2011年9月23日出願、代理人整理番号41714−703.102)の利益を主張し、この出願の全内容はその全体が参照することにより本明細書に援用される。
(技術分野)
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。糖尿病を治療する方法もまた、開示される。
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、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、身体が十分なインスリンを産生できないため生じ、2型糖尿病は、膵臓β細胞の身体自己免疫破壊から生じ、その結果、身体が十分なインスリンを産生できず、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の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)
患者の糖尿病を治療するためのシステムであって、該システムは、治療デバイスを備え、
該治療デバイスは、
十二指腸粘膜が評価されることを可能にするように構築および配列された視認構成要素と、
治療すべき該患者の十二指腸粘膜の標的区域を選択するように構築および配列された選択構成要素と、
該患者の胃および空腸に関して、治療が該患者の十二指腸を解剖学的に無傷のまま残すように、該患者の十二指腸粘膜の治療区域を治療するように構築および配列された治療構成要素と、
を含み、該治療区域は、該患者の空腸粘膜および胃粘膜のうちの少なくとも1つの中の区域と連続的である該十二指腸粘膜の中の区域を含む、システム。
(項目2)
前記治療構成要素は、前記患者の十二指腸粘膜を除去するように適応され、前記治療は、該十二指腸粘膜の中の幹細胞を排除することを含む、項目1に記載のシステム。
(項目3)
前記治療構成要素は、前記十二指腸粘膜の中の組織を切除するように適応される、項目1に記載のシステム。
(項目4)
前記治療構成要素は、前記十二指腸粘膜を切除するように適応され、該十二指腸粘膜を切除するための切除副構成要素を具備する第1のバルーンをさらに備える、項目1に記載のシステム。
(項目5)
前記治療構成要素は、前記患者の十二指腸粘膜を除去するように適応され、該十二指腸粘膜の少なくとも一部分を削取するための削取器および/または掻爬器をさらに備える、項目1に記載のシステム。
(項目6)
前記治療構成要素の削取器および/または掻爬器は、前記十二指腸粘膜を治療するための切断デバイスを具備するバルーンを備える、項目5に記載のシステム。
(項目7)
組織拡張デバイスをさらに備える、項目1に記載のシステム。
(項目8)
前記組織拡張デバイスは、前記十二指腸の粘膜下層組織を拡張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9)
患者を治療するためのシステムであって、
該システムは、
遠位部分を備える細長管と、
該細長管遠位部分上に配置された治療要素と
を備え、
該治療要素は、標的組織を治療し、非標的組織に及ぼす悪影響を減少させるように構築および配列され、
該システムは、糖尿病、1型糖尿病、2型糖尿病、高コレステロール血症、メタボリック症候群、疾患、セリアック病、肥満、癌(例えば、気管支肺胞癌)、および膀胱炎のうちの1つ以上を治療するように構築および配列されている、システム。
(項目10)
前記システムは、常習的インプラントを備えない、項目9に記載のシステム。
(項目11)
前記システムは、治療された粘膜に代わる粘膜組織が治療前粘膜と異なって機能するよう前記十二指腸の粘膜を治療するように構築および配列されている、項目9に記載のシステム。
(項目12)
前記異なる機能は、異なる分泌、異なる分泌量、および/または異なる吸収特性を含む、項目11に記載のシステム。
(項目13)
前記標的組織は、第1の部分および第2の部分を備え、前記システムは、該第1の標的組織部分を治療するための第1の治療を実施し、該第2の標的組織部分を治療するための第2の治療を実施するように構築および配列されている、項目9に記載のシステム。
(項目14)
前記第1の組織部分は、前記第2の組織部分に重複する、項目13に記載のシステム。
(項目15)
前記第1の治療は、前記第2の治療と異なる、項目13に記載のシステム。
(項目16)
前記標的組織の治療は、修正された細胞機能、細胞死、アポトーシス、細胞即死、細胞壊死、細胞の変性、細胞の除去、およびそれらの組み合わせから成る群から選択される細胞修正を含む、項目9に記載のシステム。
(項目17)
前記標的組織は、組織を備える治療組織を含み、該組織の治療が所望の治療効果を生じさせる、項目9に記載のシステム。
(項目18)
前記標的組織は、組織の安全域をさらに備え、該組織の安全域は、前記治療組織に近接する組織を備え、該組織の安全域は、前記組織治療によってほとんど影響を受けない、項目17に記載のシステム。
(項目19)
前記治療組織は、粘膜層を含み、前記組織の安全域は、粘膜下層の少なくとも一部分の層を含む、項目18に記載のシステム。
(項目20)
前記標的組織は、深さ、長さ、および幅を備え、該深さは、該長さおよび/または該幅に沿って変化する、項目9に記載のシステム。
(項目21)
前記システムは、第1の治療ステップおよび第2の治療ステップにおいて、前記標的組織を治療するように構築および配列されている、項目20に記載のシステム。
(項目22)
前記第1の治療ステップおよび前記第2の治療ステップは、異なるエネルギー送達を含む、項目21に記載のシステム。
(項目23)
前記標的組織は、第1の組織部分および第2の組織部分を含み、前記システムは、該第1の組織部分および該第2の組織部分を連続して治療するように構築および配列されている、項目9に記載のシステム。
(項目24)
前記第1の組織部分は、前記第2の組織部分と異なる特性を有する、項目23に記載のシステム。
(項目25)
前記異なる特性は、組織タイプ、例えば、組織層タイプ、組織密度、および組織厚のうちの1つ以上を含む、項目24に記載のシステム。
(項目26)
前記第1の組織治療は、前記第2の組織治療と異なる、項目24に記載のシステム。
(項目27)
前記組織治療の差異は、エネルギーレベル、送達持続時間、および送達の間の組織温度のうちの1つ以上に差異を含む、項目26に記載のシステム。
(項目28)
前記治療要素は、半径方向に拡張可能および/または半径方向に拡大可能であるように構築および配列されている、項目9に記載のシステム。
(項目29)
前記治療要素は、少なくとも1cmの直径まで、半径方向に拡張および/または半径方向に拡大するように構築および配列されている、項目28に記載のシステム。
(項目30)
前記治療要素は、約65℃〜90℃の温度の流体を含む拡張可能バルーンを備える、項目9に記載のシステム。
(項目31)
第2の治療要素をさらに備える、項目9に記載のシステム。
(項目32)
第2の細長管をさらに備え、前記第2の治療要素は、該第2の細長管上に配置される、項目31に記載のシステム。
(項目33)
前記治療要素は、エネルギーを送達するように構築および配列されている、項目9に記載のシステム。
(項目34)
前記治療要素は、閉ループエネルギー送達のために構築および配列されている、項目33に記載のシステム。
(項目35)
センサをさらに備え、前記システムは、該センサによって記録された信号に基づいてエネルギーを送達するように構築および配列されている、項目34に記載のシステム。
(項目36)
前記治療要素は、電磁エネルギー(例えば、高周波エネルギー)、音エネルギー(例えば、超音波エネルギーおよび亜音速音エネルギー)、光エネルギー(例えば、レーザエネルギー、赤外線エネルギーおよび可視光エネルギー)、化学エネルギー、熱エネルギー(例えば、高温流体から送達される熱エネルギー)、低温エネルギー、機械的エネルギー(例えば、研削要素によって送達される機械的エネルギー)から成る群から選択されるエネルギーを送達するように構築および配列されている、項目9に記載のシステム。
(項目37)
前記治療要素は、2つの形態のエネルギーを送達するように構築および配列されている、項目9に記載のシステム。
(項目38)
第2の治療要素をさらに備え、前記第1の治療要素は、第1の形態のエネルギーを送達するように構築および配列され、該第2の治療要素は、第2の形態のエネルギーを送達するように構築および配列されている、項目37に記載のシステム。
(項目39)
前記システムは、同時に、および/または連続して、前記2つの形態のエネルギーを送達するように構築および配列されている、項目37に記載のシステム。
(項目40)
前記細長管は、身体アクセスデバイスの作業チャネルを通して挿入されるように構築および配列された部分を少なくとも備える、項目9に記載のシステム。
(項目41)
前記身体アクセスデバイスは、内視鏡、腹腔鏡ポート、経胃的アクセスデバイス、血管導入器、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40に記載のシステム。
(項目42)
前記遠位部分は、偏向されるように構築および配列されている、項目9に記載のシステム。
(項目43)
第2の細長管をさらに備える、項目9に記載のシステム。
(項目44)
前記第2の細長管は、前記第1の細長管によって摺動可能に受容される、項目43に記載のシステム。
(項目45)
前記第2の細長管上に配置される第2の治療要素をさらに備える、項目43に記載のシステム。
(項目46)
信号を提供するように構築および配列されたセンサをさらに備える、項目9に記載のシステム。
(項目47)
拡張可能要素をさらに備え、前記センサは、該拡張可能要素に搭載される、項目46に記載のシステム。
(項目48)
前記センサは、熱センサ(例えば、熱電対)、インピーダンスセンサ(例えば、組織インピーダンスセンサ)、圧力センサ、血液センサ、光学センサ(例えば、光センサ)、音センサ(例えば、超音波センサ)、電磁センサ(例えば、電磁場センサ)、およびそれらの組み合わせから成る群から選択されるセンサを備える、項目46に記載のシステム。
(項目49)
機能的要素をさらに備える、項目9に記載のシステム。
(項目50)
前記機能的要素は、センサ、変換器、真空ポート、可視化要素またはデバイス(例えば、超音波結晶または光学アセンブリ)、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49に記載のシステム。
(項目51)
前記機能的要素は、真空ポートを備える、項目49に記載のシステム。
(項目52)
前記真空ポートは、組織を除去するように構築および配列されている、項目51に記載のシステム。
(項目53)
前記真空ポートは、前記システムの少なくとも一部分を組織と接触させるように構築および配列されている、項目51に記載のシステム。
(項目54)
加圧流体を送達するように構築および配列された身体管腔加圧アセンブリをさらに備える、項目9に記載のシステム。
(項目55)
前記身体管腔加圧アセンブリは、吹送流体源を備える、項目54に記載のシステム。
(項目56)
前記加圧流体の移動を阻止するように構築および配列された閉塞性要素をさらに備える、項目54に記載のシステム。
(項目57)
前記閉塞性要素は、前記細長管に搭載されている、項目56に記載のシステム。
(項目58)
身体アクセスデバイスをさらに備え、前記細長管は、該身体アクセスデバイスを通して挿入するように構築および配列されている、項目9に記載のシステム。
(項目59)
前記身体アクセスデバイスは、内視鏡、腹腔鏡ポート、経胃的アクセスデバイス、血管導入器、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58に記載のシステム。
(項目60)
エネルギーを前記治療要素まで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をさらに備える、項目9に記載のシステム。
(項目61)
前記エネルギー送達ユニットは、2つ以上の形態のエネルギーを送達するように構築および配列されている、項目60に記載のシステム。
(項目62)
前記エネルギー送達ユニットは、閉ループエネルギー送達を前記治療要素まで送達するように構築および配列されている、項目60に記載のシステム。
(項目63)
コントローラおよびユーザインターフェースをさらに備える、項目9に記載のシステム。
(項目64)
前記コントローラは、オペレータが、送達されるべきエネルギーのタイプ(例えば、RFエネルギー、熱エネルギー、および/または機械的エネルギー)、送達されるべきエネルギーの量(例えば、送達されるべきエネルギーの累積ジュール数または送達されるべきエネルギーのピーク量)、送達されるべきエネルギーの組み合わせのタイプおよびレベル、エネルギー送達持続時間、送達されるエネルギーのパルス幅変調率、研削デバイスが横断する往復運動の回数、治療要素のための温度(例えば、標的温度または最大温度)、吹送圧力、吹送持続時間、およびそれらの組み合わせから成る群から選択されるシステム入力パラメータを調整することが可能なように構築および配列されている、項目63に記載のシステム。
(項目65)
前記ユーザインターフェースは、温度情報(例えば、組織および/または治療要素温度情報)、圧力情報(例えば、バルーン圧力情報または吹送圧力情報)、力情報(例えば、組織に印加される力のレベルの情報)、患者情報(例えば、1つ以上のセンサによって記録される患者の生理学的情報)、およびそれらの組み合わせから成る群から選択されるシステム出力パラメータを表示するように構築および配列されている、項目63に記載のシステム。
(項目66)
前記治療要素を並進および/または回転させるように構築および配列された運動伝達アセンブリをさらに備える、項目9に記載のシステム。
(項目67)
組織治療の間、非標的組織を保護するように構築および配列された保護キャップをさらに備える、項目9に記載のシステム。
(項目68)
前記非標的組織は、ファーター膨大部およびオッディ括約筋のうちの少なくとも1つを備える、項目67に記載のシステム。
(項目69)
組織拡張デバイスをさらに備える、項目9に記載のシステム。
(項目70)
前記組織拡張デバイスは、粘膜下層の少なくとも一部分を拡張するように構築および配列されている、項目69に記載のシステム。
(項目71)
組織操作デバイスをさらに備える、項目9に記載のシステム。
(項目72)
前記組織操作デバイスは、軸方向直線化(例えば、十二指腸または他の腸組織の直線化)、引張(例えば、軸方向および/または半径方向引張)、厚さ拡張(例えば、注入された流体(例えば、注入された液体またはガス)による腸の粘膜下層の拡張)、組織への軸方向力の印加、組織への反対の軸方向力の印加、組織への半径方向力の印加、組織の圧縮(例えば、十二指腸の絨毛の圧縮)、局在浮腫または血管性浮腫の誘発、十二指腸の半径方向に拡張(例えば、輪状襞の突出を減少させ、それらの皺襞の重畳のため、皺襞が治療要素による治療下に置かれることを防止および減少させるため)、およびそれらの組み合わせから成る群から選択される機能を果たすように構築および配列される、項目71に記載のシステム。
(項目73)
手技完了アルゴリズムをさらに備える、項目9に記載のシステム。
(項目74)
患者を治療するための方法であって、
該方法は、
システムを提供することであって、該システムは、
遠位部分を備える細長管と、
該細長管遠位部分上に配置される治療要素と
を備える、ことと、
該治療要素によって標的組織を治療することと
を備え、
該患者は、糖尿病、1型糖尿病、2型糖尿病、高コレステロール血症、メタボリック症候群、疾患、セリアック病、肥満、癌(例えば、気管支肺胞癌)、膀胱炎、およびそれらの組み合わせから成る群から選択される疾患または障害のために治療されている、方法。
(項目75)
前記標的組織は、第1の部分および第2の部分を備え、前記方法は、
該第1の標的組織部分を治療するための第1の治療を実施することと、
該第2の標的組織部分を治療するための第2の治療を実施することと
を含む、項目74に記載の方法。
(項目76)
前記第1の組織部分は、前記第2の組織部分に重複する、項目75に記載の方法。
(項目77)
前記第1の治療は、前記第2の治療と異なる、項目75に記載の方法。
(項目78)
前記相違は、治療される標的組織区域、治療される標的組織深さ、治療される標的組織円周部分、エネルギー送達タイプ、エネルギー送達速度および/または量、エネルギー送達持続時間、およびこれらの組み合わせから成る群から選択される、項目77に記載の方法。
(項目79)
拡張流体を組織まで送達することをさらに備える、項目74に記載の方法。
(項目80)
前記拡張された組織は、粘膜下層の少なくとも一部分を備える、項目79に記載の方法。
(項目81)
患者の疾患および/または障害を治療するシステムであって、
該システムは、
治療要素を
備え、
該治療要素は、胃腸管の領域を改変するように構築および配列され、該改変は、細胞吸収容量、細胞ホルモン放出、およびそれらの組み合わせから成る群から選択される、システム。
(項目82)
患者の疾患および/または障害を治療するシステムであって、
該システムは、
標的組織を治療するように構築および配列された治療要素と、
該標的組織および/または該標的組織に近接する組織を拡張するよう構築および配列された組織拡張アセンブリと
を備える、システム。
(項目83)
患者の糖尿病を治療する方法であって、
該方法は、
該患者の胆汁塩および膵酵素にアクセスすることであって、該胆汁塩および膵酵素は、該患者によって摂取された食物と未反応である、ことと、
該未反応の胆汁塩および膵酵素を該患者の十二指腸まで送達することと
を含む、方法。
(項目84)
患者の糖尿病を治療する方法であって、
該方法は、
該患者の胆汁塩および膵酵素にアクセスすることであって、該胆汁塩および膵酵素は、該患者によって摂取された食物と未反応である、ことと、
該摂取された食物が、該患者の胆汁塩および膵酵素と反応することを防止することと、
該摂取された食物が、該患者の十二指腸粘膜と反応することを防止することと、
該アクセスされた胆汁塩および膵酵素を該患者の空腸まで送達することと
を含む、方法。
本発明の概念のシステム、方法、およびデバイスは、患者疾患または障害のための療法を提供するように、患者の標的組織を治療する。患者の糖尿病を治療するためのシステムは、視認構成要素と、選択構成要素と、治療構成要素とを備える。視認構成要素は、十二指腸粘膜の評価を可能にする。選択構成要素は、治療するための患者の十二指腸粘膜の標的区域を選択する。治療構成要素は、治療が、患者の胃および空腸に対して、患者の十二指腸を解剖学的に無傷のまま残すように、患者の十二指腸粘膜の治療区域を治療する。治療区域は、患者の空腸粘膜および胃粘膜のうちの少なくとも1つ内の区域と連続的である十二指腸粘膜の区域を含む。
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