Devices with dimensions that can be reduced and increased within the body.

JP7902114B2Active Publication Date: 2026-08-07WAVE LTD V
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
WAVE LTD V
Filing Date
2021-04-29
Publication Date
2026-08-07

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【0081】 いくつかの実施例では、近位部分は、拡開されている。いくつかの実施例では、遠位部分は、拡開されている。いくつかの実施例では、近位部分は、第2の自己拡張超弾性材料を含む。近位部分、遠位部分、および中間部分は、随意に、相互との共通のフレームから一体的に形成されている。 本発明は、例えば、以下を提供する。 (項目1) 患者の心臓の心房中隔での設置のための心房間シャントであって、 前記心房間シャントは、首部分領域によって流体連通するように結合されている第1および第2の領域を備える本体を備え、前記本体は、形状記憶材料を備え、血液が第1の心房と第2の心房との間を流動するための前記首部分領域を通した通路を画定し、 前記第1および第2の領域は、体温で超弾性を有し、前記首部分領域は、体温で可鍛性を有し、45~60℃のオーステナイト終了温度(Af)を有するニチノールを備え、 前記首部分領域を通した前記通路の流動面積は、生体内で調節され得る、 心房間シャント。 (項目2) 超弾性を有する前記第1および第2の領域は、5~20℃のオーステナイト終了温度(Af)を有するニチノールを備える、項目1に記載の心房間シャント。 (項目3) 前記首部分領域は、機械的に拡張可能である、項目1または項目2に記載の心房間シャント。 (項目4) 前記首部分領域は、熱的に収縮可能である、項目1~3のいずれか1項に記載の心房間シャント。 (項目5) 患者の心臓の心房中隔での設置のための心房間シャントであって、それを通した流体流動を調節可能に調整するための前記心房間シャントは、 前記心臓の第1の心房内に設置されるように構成されている第1の拡張可能端部領域と、 前記心臓の第2の心房内に設置されるように構成されている第2の拡張可能端部領域であって、前記第1および第2の拡張可能端部領域は、自己拡張超弾性材料を備える、第2の拡張可能端部領域と、 前記心房中隔での設置のために構成されている、前記第1および第2の拡張可能端部領域間の首部分領域であって、前記首部分領域は、可鍛性形状記憶材料を備え、前記心房間シャントは、血液が前記第1の心房と前記第2の心房との間を流動するための前記首部分領域を通した通路を画定する、首部分領域と を備え、前記首部分領域は、前記通路の断面積が生体内で調節可能であるように、前記第1および第2の拡張可能端部領域と異なる形状記憶性質を呈するように熱処理されている、心房間シャント。 (項目6) 前記可鍛性形状記憶材料は、前記通路が前記断面積から前記断面積より大きい第2の断面積まで拡張するように、生体内で拡張されるように構成されている、項目5に記載の心房間シャント。 (項目7) 前記可鍛性形状記憶材料は、前記通路が前記第2の断面積から前記第2の断面積より小さい第3の断面積まで収縮するように、生体内で収縮させられるように構成されている、項目6に記載の心房間シャント。 (項目8) 前記断面積は、4.9~28.3mm2であり、前記第2の断面積および前記第3の断面積は、15.9~78.6mm2である、項目7に記載の心房間シャント。 (項目9) 前記可鍛性形状記憶材料は、45~60℃のオーステナイト終了温度(Af)を有するニチノールを備える、項目5~8のいずれか1項に記載の心房間シャント。 (項目10) 前記自己拡張超弾性材料は、5~20℃のオーステナイト終了温度(Af)を有するニチノールを備える、項目5~9のいずれか1項に記載の心房間シャント。 (項目11) 前記可鍛性形状記憶材料は、機械的に拡張可能である、項目5~10のいずれか1項に記載の心房間シャント。 (項目12) 前記可鍛性形状記憶材料は、熱的に収縮可能である、項目5~11のいずれか1項に記載の心房間シャント。 (項目13) 前記首部分の断面積は、前記第1および第2の拡張可能端部領域のうちの少なくとも1つの個別の断面積より小さい、項目5~12のいずれか1項に記載の心房間シャント。 (項目14) 前記第1および第2の拡張可能端部領域は、前記第1および第2の拡張可能端部領域のそれぞれの端部が前記心房中隔に接触しないように、前記第1および第2の心房の中にそれぞれ延在する、項目5~13のいずれか1項に記載の心房間シャント。 (項目15) 前記第1および第2の拡張可能端部領域、ならびに前記首部分領域は、ディアボロ形状のシャントを構成する、項目5~14のいずれか1項に記載の心房間シャント。 (項目16) 前記首部分領域は、円筒形シャントを構成する、項目15に記載の心房間シャント。 (項目17) 前記円筒形シャントは、前記ディアボロ形状のシャントの外側にある、項目16に記載の心房間シャント。 (項目18) 前記円筒形シャントは、前記円筒形シャントが前記首部分領域における前記ディアボロ形状のシャントの寸法を半径方向において拘束するように、前記可鍛性形状記憶材料から形成され、前記ディアボロ形状のシャントは、前記可鍛性形状記憶材料が第2の断面積まで拡張することに応答して、前記首部分領域において自己拡張する、項目17に記載の心房間シャント。 (項目19) 前記円筒形シャントは、前記ディアボロ形状のシャントの内側にある、項目16に記載の心房間シャント。 (項目20) 前記円筒形シャントは、前記ディアボロ形状のシャントおよび前記首部分領域に直接結合されておらず、前記円筒形シャントを前記ディアボロ形状のシャントに間接的かつ弾性的に結合している被包材をさらに備える、項目16に記載の心房間シャント。 (項目21) 前記円筒形シャントの収縮は、前記首部分領域における前記ディアボロ形状のシャントの収縮を引き起こさない、項目16に記載の心房間シャント。 (項目22) 前記ディアボロ形状のシャントおよび前記円筒形シャントは、共通フレームから一体的に形成されている、項目16に記載の心房間シャント。 (項目23) 前記第1および第2の拡張可能端部領域、ならびに前記首部分領域は、共通フレームから一体的に形成されている、項目5~15のいずれか1項に記載の心房間シャント。 (項目24) 前記第1および第2の拡張可能端部領域、ならびに前記首部分領域は、少なくとも部分的に生体適合性材料で被包されている、項目5~15のいずれか1項に記載の心房間シャント。 (項目25) 第1の心房と、第2の心房と、心房中隔とを有する心臓内の流体流動を調節可能に調整するための心房間シャントであって、前記心房間シャントは、 前記第1の心房内に設置されるように構成されている、自己拡張超弾性材料を備える第1の領域であって、前記第1の領域は、体温で超弾性を有する、第1の領域と、 流体流動を前記第1の心房から前記第2の心房に提供するために、前記心房中隔内の開口部を通して設置されるように構成されている、可鍛性形状記憶材料を備える第2の領域であって、前記第2の領域は、体温で可鍛性を有する、前記第2の領域と を備え、 前記可鍛性形状記憶材料は、第1の断面積を有し、 前記可鍛性形状記憶材料は、前記第1の断面積から第2の断面積まで拡張可能であり、 前記可鍛性形状記憶材料は、前記第2の断面積から第3の断面積まで収縮可能である、 心房間シャント。 (項目26) 前記自己拡張超弾性材料は、5~20℃のオーステナイト終了温度(Af)を有するニチノールを備え、前記可鍛性形状記憶材料は、45~60℃のオーステナイト終了温度(Af)を有するニチノールを備える、項目25に記載の心房間シャント。 (項目27) 前記可鍛性形状記憶材料は、機械的に拡張可能であり、熱的に収縮可能である、項目25または項目26に記載の心房間シャント。 (項目28) 前記第2の心房内に設置されるように構成され、前記第2の領域に結合されている、第2の自己拡張超弾性材料を備える第3の領域をさらに備える、項目25~27のいずれか1項に記載の心房間シャント。 (項目29) デバイスであって、それを通した流体流動を生体内で調節可能に調整するための前記デバイスは、 第1の自己拡張超弾性材料を備える第1の構成要素と、 前記第1の構成要素に結合され、第1の可鍛性形状記憶材料を備える第2の構成要素と を備え、 前記第1の可鍛性形状記憶材料は、第1の断面積を有し、 前記第1の可鍛性形状記憶材料は、第2の断面積まで生体内で拡張可能であり、 前記第1の可鍛性形状記憶材料は、第3の断面積まで生体内で収縮可能である、 デバイス。 (項目30) 前記第1の自己拡張超弾性材料は、37℃未満のオーステナイト終了温度(Af)を有するニチノールを備える、項目29に記載のデバイス。 (項目31) 前記第1の自己拡張超弾性材料の前記ニチノールのAfは、5~20℃である、項目30に記載のデバイス。 (項目32) 前記第1の可鍛性形状記憶材料は、37℃を上回るオーステナイト終了温度(Af)を有するニチノールを備える、項目29~31のいずれか1項に記載のデバイス。 (項目33) 前記可鍛性形状記憶材料の前記ニチノールのAfは、45~60℃である、項目32に記載のデバイス。 (項目34) 前記第1の可鍛性形状記憶材料は、機械的に拡張可能である、項目29~33のいずれか1項に記載のデバイス。 (項目35) 前記第1の可鍛性形状記憶材料は、熱的に収縮可能である、項目29~34のいずれか1項に記載のデバイス。 (項目36) 前記第1の可鍛性形状記憶材料は、溶接によって前記第1の自己拡張超弾性材料に継合されている、項目29~35のいずれか1項に記載のデバイス。 (項目37) 前記デバイスは、複数の成形されたワイヤを備え、前記ワイヤのうちの少なくとも1つは、前記第1の可鍛性形状記憶材料を備え、前記ワイヤのうちの少なくとも1つは、前記第1の自己拡張超弾性材料を備える、項目29~36のいずれか1項に記載のデバイス。 (項目38) 前記ワイヤのうちの少なくとも1つは、前記第1の可鍛性形状記憶材料および前記第1の自己拡張超弾性材料の両方を備える、項目37に記載のデバイス。 (項目39) 前記ワイヤの各々は、前記第1の可鍛性形状記憶材料および前記第1の自己拡張超弾性材料の両方を備える、項目37に記載のデバイス。 (項目40) 前記成形されたワイヤの各々は、第1の端部と、第2の端部とを備え、前記第1および第2の端部は、オーバーラッピング、溶接、またはスウェージ加工されたチューブを使用して相互に結合されている、項目37~39のいずれか1項に記載のデバイス。 (項目41) 前記ワイヤは、巻線またはスリーブを使用して相互に結合されている、項目37~40のいずれか1項に記載のデバイス。 (項目42) 前記スリーブのうちの少なくとも1つは、放射線不透過性を有する、項目41に記載のデバイス。 (項目43) 前記スリーブの各々は、放射線不透過性を有する、項目41に記載のデバイス。 (項目44) 前記ワイヤのうちの少なくとも1つは、放射線不透過性材料を備える、項目37~43のいずれか1項に記載のデバイス。 (項目45) 前記ワイヤの内部コアは、前記放射線不透過性材料を備える、項目44に記載のデバイス。 (項目46) 前記ワイヤの上層は、前記第1の可鍛性形状記憶材料または前記第1の自己拡張超弾性材料を備える、項目45に記載のデバイス。 (項目47) 前記ワイヤの撚り線は、前記第1の可鍛性形状記憶材料または前記第1の自己拡張超弾性材料を備える、項目45に記載のデバイス。 (項目48) 前記ワイヤの上層は、前記放射線不透過性材料を備える、項目45に記載のデバイス。 (項目49) 前記ワイヤの内部コアは、前記第1の可鍛性形状記憶材料または前記第1の自己拡張超弾性材料を備える、項目48に記載のデバイス。 (項目50) 前記第1の構成要素および前記第2の構成要素のうちの少なくとも1つの少なくとも一部を被覆する被包材をさらに備える、項目29~49のいずれか1項に記載のデバイス。 (項目51) 前記被包材は、前記第1の可鍛性形状記憶材料を前記第1の自己拡張超弾性材料に継合している、項目50に記載のデバイス。 (項目52) 前記第1の断面積は、前記第3の断面積より小さい、項目29~51のいずれか1項に記載のデバイス。 (項目53) 前記第1の断面積は、前記第3の断面積より大きい、項目29~51のいずれか1項に記載のデバイス。 (項目54) 前記デバイスは、第3の構成要素をさらに備え、前記第3の構成要素は、第2の自己拡張超弾性材料を備え、前記第1の構成要素および前記第2の構成要素に結合されている、項目29~53のいずれか1項に記載のデバイス。 (項目55) 前記第1の構成要素は、入口を備え、前記第2の構成要素は、首部分を備え、前記第3の構成要素は、前記首部分を介して前記入口に流体的に結合されている出口を備える、項目54に記載のデバイス。 (項目56) 前記首部分の断面積は、前記入口および前記出口のうちの少なくとも1つの個別の断面積より小さい、項目55に記載のデバイス。 (項目57) 前記入口および前記出口は、身体内の2つの心室間の中隔を通した開口部内に前記デバイスを留め、前記首部分は、これらの心室間の流動のためのチャネルを提供する、項目56に記載のデバイス。 (項目58) 前記首部分の断面積は、前記入口および前記出口のうちの少なくとも1つの個別の断面積より大きい、項目55に記載のデバイス。 (項目59) 前記第2の構成要素は、人体の開口部に係合するように構成されている、項目55に記載のデバイス。 (項目60) 前記開口部は、右心房と左心房との間の心房間中隔の卵円窩を通して作り出され、 前記首部分は、前記開口部に係合するように構成され、 前記入口は、前記右心房の中へと延在するように構成され、 前記出口は、前記左心房の中へと延在するように構成されている、 項目59に記載のデバイス。 (項目61) 前記入口および前記出口は、フランジを備え、 前記首部分は、可撓性長手方向バーおよび正弦曲線リングを備え、 前記可撓性長手方向バーは、展開時に前記フランジが完全に拡張することを可能にし、 前記正弦曲線リングは、バルーン膨張または熱収縮させられたとき、その直径を維持するために十分な強度を有する、 項目60に記載のデバイス。 (項目62) 前記第1の構成要素は、人体内の管腔に係合するように構成されている、項目55に記載のデバイス。 (項目63) 前記管腔は、血管を含み、 前記第1および第3の構成要素は、前記血管に係合するように構成されている、 項目62に記載のデバイス。 (項目64) 前記首部分は、前記血管の口に隣接して配置されるように構成されている、項目63に記載のデバイス。 (項目65) 前記デバイスは、第3の構成要素をさらに備え、前記第3の構成要素は、第2の可鍛性形状記憶材料を備え、前記第1の構成要素および前記第2の構成要素に結合されている、項目29~53のいずれか1項に記載のデバイス。 (項目66) 前記第2の可鍛性形状記憶材料は、第4の断面積を有し、前記第4の断面積は、それを通した流体流動の第4の率を可能にし、 前記第2の可鍛性形状記憶材料は、第5の断面積まで生体内で拡張可能であり、前記第5の断面積は、それを通した流体流動の第5の率を可能にし、 前記第2の可鍛性形状記憶材料は、第6の断面積まで生体内で収縮可能であり、前記第6の断面積は、それを通した流体流動の第6の率を可能にする、 項目65に記載のデバイス。 (項目67) 前記第2の構成要素は、入口を備え、前記第3の構成要素は、前記第1の構成要素を介して前記入口に流体的に結合されている出口を備える、項目65または項目66に記載のデバイス。 (項目68) 前記入口は、人体内の血管に係合するように構成され、 前記第1の構成要素は、前記血管に係合するように構成され、 前記出口は、前記血管の口の中へと延在するように構成されている、 項目67に記載のデバイス。 (項目69) 前記デバイスは、前記第2の構成要素内に配置された弁をさらに備え、 前記第1の構成要素は、人体内の血管に係合するように構成され、 前記第2の構成要素は、前記血管の中へと延在する、 項目29~53のいずれか1項に記載のデバイス。 (項目70) 前記第2の構成要素は、前記第1の構成要素の内側に位置している、項目29~53のいずれか1項に記載のデバイス。 (項目71) 前記第1の構成要素は、首部分を有するディアボロ形状のシャントを構成し、前記第2の構成要素は、前記首部分を囲む構造部材を構成する、項目29~53のいずれか1項に記載のデバイス。 (項目72) 前記構造部材は、円筒形シャントを構成する、項目71に記載のデバイス。 (項目73) 前記構造部材は、圧縮コイルを構成する、項目71に記載のデバイス。 (項目74) 前記圧縮コイルが前記首部分の周囲に巻着する回数は、前記首部分の断面積に基づいて変動する、項目73に記載のデバイス。 (項目75) 前記圧縮コイルは、実質的に円筒形である、項目74に記載のデバイス。 (項目76) 前記構造部材は、圧縮ばねを構成する、項目71に記載のデバイス。 (項目77) 前記圧縮ばねが前記首部分の周囲に巻着する回数は、前記首部分の断面積に基づいて変動する、項目76に記載のデバイス。 (項目78) 前記圧縮ばねは、ディアボロ形状である、項目77に記載のデバイス。 (項目79) 前記圧縮ばねを前記シャントに結合しているフックをさらに備える、項目76~78のいずれか1項に記載のデバイス。 (項目80) 前記構造部材は、前記ディアボロ形状のシャントの外側にある、項目71に記載のデバイス。 (項目81) 前記第1の可鍛性形状記憶材料は、前記首部分の寸法を半径方向において拘束する、項目71に記載のデバイス。 (項目82) 前記第1の可鍛性形状記憶材料は、前記首部分がより大きい寸法まで自己拡張しないように拘束するために、半径方向において前記首部分の外面に接触している、項目81に記載のデバイス。 (項目83) 前記首部分は、前記第1の可鍛性形状記憶材料が前記第2の断面積まで拡張することに応答して自己拡張する、項目82に記載のデバイス。 (項目84) 前記構造部材は、前記首部分の断面積に基づいて変動する力を前記首部分に及ぼす、項目71に記載のデバイス。 (項目85) 前記第1の構成要素を通した内側管腔を形成する被包材をさらに備える、項目71に記載のデバイス。 (項目86) 前記被包材は、前記第1の構成要素の外側被覆をさらに形成する、項目85に記載のデバイス。 (項目87) 前記被包材は、前記第2の構成要素の外側被覆をさらに形成する、項目86に記載のデバイス。 (項目88) 前記円筒形シャントは、前記ディアボロ形状のシャントの内側にある、項目71に記載のデバイス。 (項目89) 前記円筒形シャントは、前記ディアボロ形状のシャントの前記首部分に直接結合されておらず、 前記デバイスは、前記円筒形シャントを前記ディアボロ形状のシャントに間接的かつ弾性的に結合している被包材をさらに備える、 項目88に記載のデバイス。 (項目90) 前記円筒形シャントの収縮は、前記ディアボロ形状のシャントの前記首部分の収縮を引き起こさない、項目89に記載のデバイス。 (項目91) 前記ディアボロ形状のシャントの前記首部分は、第4の断面積まで自己拡張可能である、項目89に記載のデバイス。 (項目92) 前記第3の断面積への前記円筒形シャントの収縮は、前記首部分の断面積を変化させない、項目91に記載のデバイス。 (項目93) 前記第2の構成要素は、前記第1の構成要素の内側に位置している、項目29~53のいずれか1項に記載のデバイス。 (項目94) 前記第1の可鍛性形状記憶材料は、前記第1の構成要素の寸法を半径方向において拘束する、項目93に記載のデバイス。 (項目95) 前記第1の可鍛性形状記憶材料は、前記第1の構成要素がより小さい寸法まで収縮しないように拘束するために、半径方向において前記第1の構成要素の内面に接触している、項目94に記載のデバイス。 (項目96) 前記第1の構成要素は、前記第1の可鍛性形状記憶材料が前記第3の断面積まで収縮することに応答して自己収縮する、項目93に記載のデバイス。 (項目97) 前記第1の構成要素および前記第2の構成要素の外側被覆を形成する被包材をさらに備える、項目93に記載のデバイス。 (項目98) 前記第1の構成要素および前記第2の構成要素は、相互との共通のフレームから一体的に形成されている、項目29に記載のデバイス。 (項目99) 前記共通フレームは、実質的に円筒形である、項目98に記載のデバイス。 (項目100) 前記共通フレームは、前記第1の自己拡張超弾性材料を備える第3の構成要素をさらに備え、 前記第2の構成要素は、前記共通フレームの中心部分を形成し、 前記第1および第3の構成要素は、前記心臓のそれぞれの心房の中へと延在するように構成されている前記共通フレームの部分を形成する、 項目98または項目99に記載のデバイス。 (項目101) 前記第2の構成要素は、前記心房中隔を通した開口に係合するように構成されている溝を備える、項目100に記載のデバイス。 (項目102) 前記第1および第3の構成要素は、拡開されている、項目100または項目101に記載のデバイス。 (項目103) 前記流体は、血液である、項目29~102のいずれか1項に記載のデバイス。 (項目104) 心臓の心房中隔からデバイスを回収する方法であって、前記方法は、 前記デバイスを通して回収カテーテルを配置することであって、前記回収カテーテルは、その中に配置されたチップおよびカップを有する、ことと、 前記チップが前記心臓の左心房内に留まっている間、前記カップを前記心臓の右心房まで後退させ、前記デバイスの位置と一致する前記チップと前記カップとの間の空間を残すことと、 前記デバイスを加熱し、前記デバイスをヒートセット構成に収縮させることと、 前記チップを後退させ、前記収縮させられたデバイスを前記カップの中へと引動することと、 前記収縮させられたデバイスが少なくとも部分的に前記チップおよび前記カップの各々内にある状態で、前記心臓から前記回収カテーテルを回収することと を含む、方法。 (項目105) デバイスを用意する方法であって、前記方法は、各そのようなデバイスの1つまたはそれより多くの部分の局所的な熱処理を使用して、前記デバイスの加熱されない部分(単数または複数)と異なるAfを生み出すことを含む、方法。 (項目106) 前記デバイスの前記1つまたはそれより多くの部分の前記局所的な加熱は、隣接するエリアの能動冷却を随意に伴って、誘導加熱を使用して実施される、項目105に記載の方法。 (項目107) 前記デバイスの前記1つまたはそれより多くの部分の前記局所的な加熱は、隣接するエリアの能動冷却を随意に伴って、局所的なレーザ加熱を使用して実施される、項目105に記載の方法。 (項目108) デバイスを用意する方法であって、前記方法は、 相互と異なるオーステナイト終了(Af)温度を有するワイヤ、および/またはワイヤの長さに沿って異なるAf温度を有するワイヤを提供することと、 前記ワイヤを使用して、前記デバイスが複数のAf温度を有するように前記デバイスを製造することと を含む、方法。 (項目109) 前記異なるAf温度は、ニチノールの異なる相に対応する、項目108に記載の方法。 (項目110) 前記ワイヤを使用して前記デバイスを製造することは、ワイヤ巻着技法、ワイヤメッシュ技法、またはそれらの任意の好適な組み合わせを使用することを含む、項目108に記載の方法。 (項目111) デバイスであって、それを通した流体流動を調節可能に調整するための前記デバイスは、 第1の自己拡張超弾性材料を備える第1の構成要素と、 前記第1の構成要素に結合され、第1の可鍛性形状記憶材料を備える第2の構成要素と を備え、 前記第1の可鍛性形状記憶材料は、第1の断面積を有し、 前記第1の可鍛性形状記憶材料は、第2の断面積まで拡張可能であり、 前記第1の可鍛性形状記憶材料は、第3の断面積まで収縮可能である、 デバイス。 (項目112) 前記第1の自己拡張超弾性材料は、37℃未満のオーステナイト終了温度(Af)を有するニチノールを備える、項目111に記載のデバイス。 (項目113) 前記第1の自己拡張超弾性材料の前記ニチノールのAfは、5~20℃である、項目112に記載のデバイス。 (項目114) 前記第1の可鍛性形状記憶材料は、37℃を上回るオーステナイト終了温度(Af)を有するニチノールを備える、項目111~113のいずれか1項に記載のデバイス。 (項目115) 前記可鍛性形状記憶材料の前記ニチノールのAfは、45~60℃である、項目114に記載のデバイス。 (項目116) 前記第1の可鍛性形状記憶材料は、機械的に拡張可能である、項目111~115のいずれか1項に記載のデバイス。 (項目117) 前記第1の可鍛性形状記憶材料は、熱的に収縮可能である、項目111~116のいずれか1項に記載のデバイス。 (項目118) 前記第1の可鍛性形状記憶材料は、溶接によって前記第1の自己拡張超弾性材料に継合されている、項目111~117のいずれか1項に記載のデバイス。 (項目119) 前記第1の構成要素および前記第2の構成要素のうちの少なくとも1つの少なくとも一部を被覆する被包材をさらに備える、項目111~118のいずれか1項に記載のデバイス。 (項目120) 前記被包材は、前記第1の可鍛性形状記憶材料を前記第1の自己拡張超弾性材料に継合している、項目119に記載のデバイス。 (項目121) 前記第1の断面積は、前記第3の断面積より小さい、項目111~120のいずれか1項に記載のデバイス。 (項目122) 前記第1の断面積は、前記第3の断面積より大きい、項目111~121のいずれか1項に記載のデバイス。 (項目123) 前記デバイスは、第3の構成要素をさらに備え、前記第3の構成要素は、第2の自己拡張超弾性材料を備え、前記第1の構成要素および前記第2の構成要素に結合されている、項目111~122のいずれか1項に記載のデバイス。 (項目124) 前記第1の構成要素は、入口を備え、前記第2の構成要素は、首部分を備え、前記第3の構成要素は、前記首部分を介して前記入口に流体的に結合されている出口を備える、項目123に記載のデバイス。 (項目125) 前記首部分の断面積は、前記入口および前記出口のうちの少なくとも1つの個別の断面積より小さい、項目124に記載のデバイス。 (項目126) 前記入口および前記出口は、身体内の2つの心室間の中隔を通した開口部内に前記デバイスを留め、前記首部分は、これらの心室間の流動のためのチャネルを提供する、項目125に記載のデバイス。 (項目127) 前記首部分の断面積は、前記入口および前記出口のうちの少なくとも1つの個別の断面積より大きい、項目124に記載のデバイス。 (項目128) 前記第2の構成要素は、人体の開口部に係合するように構成されている、項目123~127のいずれか1項に記載のデバイス。 (項目129) 前記開口部は、右心房と左心房との間の心房間中隔の卵円窩を通して作り出され、 前記首部分は、前記開口部に係合するように構成され、 前記入口は、前記右心房の中へと延在するように構成され、 前記出口は、前記左心房の中へと延在するように構成されている、 項目124に従属する項目128に記載のデバイス。 (項目130) 前記第1の構成要素は、人体内の管腔に係合するように構成されている、項目111~126のいずれか1項に記載のデバイス。 (項目131) 前記管腔は、血管を含み、 前記第1および第3の構成要素は、前記血管に係合するように構成されている、 項目111~126または129または130のいずれか1項に記載のデバイス。 (項目132) 前記首部分は、前記血管の口に隣接して配置されるように構成されている、項目124に従属する項目131に記載のデバイス。 (項目133) 前記デバイスは、第3の構成要素をさらに備え、前記第3の構成要素は、第2の可鍛性形状記憶材料を備え、前記第1の構成要素および前記第2の構成要素に結合されている、項目111~122のいずれか1項に記載のデバイス。 (項目134) 前記第2の可鍛性形状記憶材料は、第4の断面積を有し、前記第4の断面積は、それを通した流体流動の第4の率を可能にし、 前記第2の可鍛性形状記憶材料は、第5の断面積まで拡張可能であり、前記第5の断面積は、それを通した流体流動の第5の率を可能にし、 前記第2の可鍛性形状記憶材料は、第6の断面積まで収縮可能であり、前記第6の断面積は、それを通した流体流動の第6の率を可能にする、 項目133に記載のデバイス。 (項目135) 前記第2の構成要素は、入口を備え、前記第3の構成要素は、前記第1の構成要素を介して前記入口に流体的に結合されている出口を備える、項目133または項目134に記載のデバイス。 (項目136) 前記入口は、人体内の血管に係合するように構成され、 前記第1の構成要素は、前記血管に係合するように構成され、 前記出口は、前記血管の口の中へと延在するように構成されている、 項目135に記載のデバイス。 (項目137) 前記第2の構成要素内に配置された弁をさらに備え、 前記第1の構成要素は、人体内の血管に係合するように構成され、 前記第2の構成要素は、前記血管の中へと延在する、 項目111~122のいずれか1項に記載のデバイス。 (項目138) 前記第2の構成要素は、前記第1の構成要素の内側に位置している、項目111~122のいずれか1項に記載のデバイス。 (項目139) 前記第1の構成要素は、首部分を有するディアボロ形状のシャントを構成し、前記第2の構成要素は、円筒形シャントを構成する、項目111~122のいずれか1項に記載のデバイス。 (項目140) 前記円筒形シャントは、前記ディアボロ形状のシャントの外側にある、項目139に記載のデバイス。 (項目141) 前記第1の可鍛性形状記憶材料は、前記首部分の寸法を半径方向において拘束する、項目140に記載のデバイス。 (項目142) 前記第1の可鍛性形状記憶材料は、前記首部分がより大きい寸法まで自己拡張しないように拘束するために、半径方向において前記首部分の外面に接触している、項目141に記載のデバイス。 (項目143) 前記首部分は、前記第1の可鍛性形状記憶材料が前記第2の断面積まで拡張することに応答して自己拡張する、項目141または項目142に記載のデバイス。 (項目144) 前記第1の構成要素を通した内側管腔と、前記第1の構成要素および前記第2の構成要素の外側被覆とを形成する被包材をさらに備える、項目140~143のいずれか1項に記載のデバイス。 (項目145) 前記円筒形シャントは、前記ディアボロ形状のシャントの内側にある、項目139に記載のデバイス。 (項目146) 前記円筒形シャントは、前記ディアボロ形状のシャントの前記首部分に直接結合されておらず、 前記デバイスは、前記円筒形シャントを前記ディアボロ形状のシャントに間接的かつ弾性的に結合している被包材をさらに備える、 項目145に記載のデバイス。 (項目147) 前記円筒形シャントの収縮は、前記首部分の収縮を引き起こさない、項目146に記載のデバイス。 (項目148) 前記ディアボロ形状のシャントの前記首部分は、第4の断面積まで自己拡張可能である、項目146に記載のデバイス。 (項目149) 前記第3の断面積への前記円筒形シャントの収縮は、前記首部分の断面積を変化させない、項目148に記載のデバイス。 (項目150) 前記第2の構成要素は、前記第1の構成要素の内側に位置している、項目111~122のいずれか1項に記載のデバイス。 (項目151) 前記第1の可鍛性形状記憶材料は、前記第1の構成要素の寸法を半径方向において拘束する、項目150に記載のデバイス。 (項目152) 前記第1の可鍛性形状記憶材料は、前記第1の構成要素がより小さい寸法まで収縮しないように拘束するために、半径方向において前記第1の構成要素の内面に接触している、項目151に記載のデバイス。 (項目153) 前記第1の構成要素は、前記第1の可鍛性形状記憶材料が前記第3の断面積まで収縮することに応答して自己収縮する、項目150~152のいずれか1項に記載のデバイス。 (項目154) 前記第1の構成要素および前記第2の構成要素の外側被覆を形成する被包材をさらに備える、項目150~153のいずれか1項に記載のデバイス。 (項目155) 生体内でデバイスの内部寸法を縮小および増大させるための方法であって、前記方法は、 相互に結合されている第1および第2の構成要素を流路の中に挿入することであって、 前記第1の構成要素は、自己拡張超弾性材料を備え、 前記第2の構成要素は、第1の断面積を有する可鍛性形状記憶材料を備える、 ことと、 前記可鍛性形状記憶材料を第2の断面積まで拡張させることと、 前記可鍛性形状記憶材料を第3の断面積まで収縮させることと を含む、方法。 (項目156) 前記可鍛性形状記憶材料を収縮させることは、前記可鍛性形状記憶材料を加熱することを含む、項目155に記載の方法。 (項目157) 前記加熱することは、カテーテルを介して、加熱された生理食塩水を前記デバイスを通して流動させることを含む、項目156に記載の方法。 (項目158) 前記加熱することは、無線周波数(RF)エネルギーを前記デバイスに適用することを含む、項目156に記載の方法。 (項目159) 前記可鍛性形状記憶材料を拡張させることは、バルーンを前記可鍛性形状記憶材料内で拡張させることを含む、項目155~158のいずれか1項に記載の方法。 (項目160) 流体流動を調節可能に調整するための方法であって、前記方法は、 相互に結合されている第1および第2の構成要素を流路の中に挿入することであって、 前記第1の構成要素は、自己拡張超弾性材料を備え、 前記第2の構成要素は、第1の断面積を有する可鍛性形状記憶材料を備え、前記第1の断面積は、それを通した流体流動の第1の率を可能にする、 ことと、 前記可鍛性形状記憶材料を第2の断面積まで拡張させることであって、前記第2の断面積は、それを通した流体流動の第2の率を可能にする、ことと、 前記可鍛性形状記憶材料を第3の断面積まで収縮させることであって、前記第3の断面積は、それを通した流体流動の第3の率を可能にする、ことと を含む、方法。 (項目161) 前記可鍛性形状記憶材料を収縮させることは、前記可鍛性形状記憶材料を加熱することを含む、項目160に記載の方法。 (項目162) 前記加熱することは、カテーテルを介して、加熱された生理食塩水を前記デバイスを通して流動させることを含む、項目161に記載の方法。 (項目163) 前記加熱することは、無線周波数(RF)エネルギーを前記デバイスに適用することを含む、項目161に記載の方法。 (項目164) 前記可鍛性形状記憶材料を拡張させることは、バルーンを前記可鍛性形状記憶材料内で拡張させることを含む、項目160~163のいずれか1項に記載の方法。 (項目165) 身体管腔内での固定のための再位置付け可能デバイスであって、前記デバイスは、 自己拡張超弾性材料を備える第1の構成要素と、 前記第1の構成要素に結合され、可鍛性形状記憶材料を備える第2の構成要素と を備え、 前記自己拡張超弾性材料は、所定の完全に拡張された寸法を有し、 前記第2の構成要素は、カテーテルを通した展開のために好適な第1の寸法を有し、 前記可鍛性形状記憶材料は、身体管腔内での固定のための第2の寸法まで拡張可能であり、 前記可鍛性形状記憶材料は、第3の寸法まで熱的に遷移可能であり、 前記可鍛性形状記憶材料は、第4の寸法まで機械的に再拡張可能である、 デバイス。 (項目166) デバイスを身体管腔内に調節可能に固定するための方法であって、前記方法は、 相互に結合されている第1および第2の構成要素を備えるデバイスを身体管腔の中に挿入することであって、 前記第1の構成要素は、自己拡張超弾性材料を備え、 前記第2の構成要素は、第1の寸法を有する可鍛性形状記憶材料を備える、 ことと、 前記可鍛性形状記憶材料を第2の寸法まで拡張させ、前記デバイスを身体管腔内に固定することと、 前記可鍛性形状記憶材料を熱的に収縮させることと、 前記可鍛性形状記憶材料が熱的に収縮させられている間に、前記デバイスを前記身体管腔内に再位置付けすることと、 前記可鍛性形状記憶材料を第3の寸法まで機械的に再拡張させ、前記デバイスを前記身体管腔内に固定することと を含む、方法。 (項目167) 前記可鍛性形状記憶材料を熱的に収縮させることは、前記可鍛性形状記憶材料を加熱することを含む、項目166に記載の方法。 (項目168) 前記加熱することは、カテーテルを介して、加熱された生理食塩水を前記デバイスを通して流動させることを含む、項目167に記載の方法。 (項目169) 前記加熱することは、無線周波数(RF)エネルギーを前記デバイスに適用することを含む、項目167に記載の方法。 (項目170) 前記可鍛性形状記憶材料を機械的に拡張させることは、バルーンを前記可鍛性形状記憶材料内で拡張させることを含む、項目166~169のいずれか1項に記載の方法。 (項目171) 人体の領域を通した開口部を拡大するためのダイレータであって、前記ダイレータは、 近位端および遠位端を有するシースと、 前記シースの前記遠位端に配置され、先端、拡大領域、および縮小領域を備えるダイレータと を備え、 前記縮小領域は、前記シースの前記遠位端と固着係合するようにサイズ決めされ、 前記拡大領域は、前記シースと前記先端との間に滑らかなプロファイルを提供するようにサイズ決めされ、 前記先端の遠位端は、ほぼ点になるまでテーパ状になっており、 少なくとも前記拡大領域および前記縮小領域は、37℃を実質的に上回るオーステナイト終了温度(Af)を有するマルテンサイト形状記憶材料を備え、それによって、身体内での熱の適用時、前記形状記憶材料は、前記ダイレータが実質的に滑らかな縮小されたサイズプロファイルを有するような、より小さいヒートセット外側寸法に戻る、 ダイレータ。 (項目172) 前記先端も、前記マルテンサイト形状記憶材料を含む、項目171に記載のダイレータ。 (項目173) 前記先端は、自己拡張超弾性材料を含む、項目171に記載のダイレータ。 (項目174) 項目171~173のいずれか1項に記載のダイレータと、前記開口部内で展開するデバイスとを含むシステム。 (項目175) 人体の領域を通した拡大開口部を形成するための方法であって、前記方法は、 人体の前記領域を通してガイドワイヤを配置し、開口部を形成することと、 前記ガイドワイヤを経由して、前記開口部を通してダイレータを押動し、拡大開口部を形成することと、 前記ダイレータを加熱し、前記ダイレータのサイズを縮小させることと、 前記ダイレータが前記縮小されたサイズを有している間に、前記拡大開口部を通して前記ダイレータを抜去することと を含む、方法。 (項目176) 前記加熱することは、カテーテルを介して、加熱された生理食塩水を前記ダイレータを通して流動させることを含む、項目175に記載の方法。 (項目177) 前記加熱することは、無線周波数(RF)エネルギーを前記ダイレータに適用することを含む、項目175に記載の方法。 (項目178) デバイスを前記開口部内で展開することと、前記デバイスを通して前記ダイレータを抜去することとをさらに含む、項目175~178のいずれか1項に記載の方法。 (項目179) 経心房ゲートであって、 第1の自己拡張超弾性材料を備える左心房ディスクと、 第2の自己拡張超弾性材料を備える右心房ディスクと、 前記左および右心房ディスク間の通過を可能にするように拡張可能である前記左および右心房ディスク間の通路を完全に閉塞するためにヒートセットされるマルテンサイト形状記憶材料と を備える経心房ゲート。 (項目180) 前記マルテンサイト形状記憶材料は、メッシュとして提供される、項目179に記載の経心房ゲート。 (項目181) 前記マルテンサイト形状記憶材料は、バルーン拡張可能である、項目179または項目180に記載の経心房ゲート。 (項目182) 前記マルテンサイト形状記憶材料は、前記左および右心房ディスク間の通過を可能にするように拡張された後、熱の適用によって閉鎖可能であるように構成されている、項目179~181のいずれか1項に記載の経心房ゲート。 (項目183) 手順を実施する方法であって、前記方法は、 心臓の心房中隔内の開口部を通して経心房ゲートを埋め込むことであって、前記経心房ゲートは、 第1の自己拡張超弾性材料を備える左心房ディスクと、 第2の自己拡張超弾性材料を備える右心房ディスクと、 前記左および右心房ディスク間の通路を完全に閉塞するためにヒートセットされるマルテンサイト形状記憶材料と を備える、ことと、 前記マルテンサイト形状記憶材料を拡張させ、前記左および右心房ディスク間の通過を可能にすることと を含む、方法。 (項目184) 前記材料は、血液を備える、項目183に記載の方法。 (項目185) 前記材料は、器具を備える、項目183または項目184に記載の方法。 (項目186) 前記方法は、前記器具を使用して、前記心臓の左心房内で付加的手順を実施することを含む、項目185に記載の方法。 (項目187) 前記付加的手順は、RFアブレーション、左心耳閉鎖、MitraClip埋込、僧帽弁置換、または僧帽弁修復を含む、項目186に記載の方法。 (項目188) 前記マルテンサイト形状記憶材料は、メッシュとして提供される、項目183~187のいずれか1項に記載の方法。 (項目189) 前記マルテンサイト形状記憶材料は、バルーンを使用して拡張される、項目183~188のいずれか1項に記載の方法。 (項目190) 前記拡張後、熱の適用によって前記マルテンサイト形状記憶材料を閉鎖することをさらに含む、項目183~189のいずれか1項に記載の方法。 (項目191) 装置であって、前記装置は、 デバイスであって、 心臓の第1の心房内に配置されるように構成されている近位部分と、 心臓の第2の心房内に配置されるように構成され、第1の自己拡張超弾性材料を備える遠位部分と、 前記近位部分と前記遠位部分との間に配置され、前記第1の心房と前記第2の心房との間の心房中隔内に配置されるように構成されている中間部分であって、前記中間部分は、可鍛性形状記憶材料を備える、中間部分と を備えるデバイスと、 カテーテルと、 少なくとも1つの収斂可撓性長手方向要素と を備え、 前記第1の自己拡張超弾性材料は、所定の完全に拡張された寸法を有し、 前記中間部分は、前記カテーテルを通した展開のために好適な第1の寸法を有し、 前記中間部分は、前記中隔内での固定のための第2の寸法まで拡張可能であり、 前記中間部分は、第3の寸法まで熱的に遷移可能であり、 前記中間部分は、第4の寸法まで機械的に再拡張可能であり、 前記デバイスは、前記少なくとも1つの収斂可撓性長手方向要素を使用して、前記デバイスを前記カテーテルの中へと引き寄せることによって除去可能である、 装置。 (項目192) 前記近位部分は、拡開されている、項目191に記載のデバイス。 (項目193) 前記遠位部分は、拡開されている、項目191または項目192に記載のデバイス。 (項目194) 前記近位部分は、第2の自己拡張超弾性材料を備える、項目191~193のいずれか1項に記載のデバイス。 (項目195) 方法であって、前記方法は、 カテーテルを通して、デバイスを心臓の心房中隔を通して展開することであって、 前記デバイスは、 前記心臓の第1の心房内に配置された近位部分と、 前記心臓の第2の心房内に配置され、第1の自己拡張超弾性材料を備える遠位部分と、 前記近位部分と前記遠位部分との間に配置され、前記第1の心房と前記第2の心房との間の前記心房中隔内に配置された中間部分であって、前記中間部分は、可鍛性形状記憶材料を備える、中間部分と を備え、 前記第1の自己拡張超弾性材料は、所定の完全に拡張された寸法を有し、 前記中間部分は、前記カテーテルを通して展開されたとき、第1の寸法を有する、 ことと、 前記中間部分を前記中隔内での固定のための第2の寸法まで拡張させることと、 前記中間部分を第3の寸法まで熱的に遷移させることと、 前記中間部分を第4の寸法まで機械的に再拡張させることと、 少なくとも1つの収斂可撓性長手方向要素を使用して、前記デバイスを前記カテーテルの中へと引き寄せることによって前記デバイスを除去することと を含む、方法。 (項目196) 前記近位部分は、拡開されている、項目195に記載の方法。 (項目197) 前記遠位部分は、拡開されている、項目195または項目196に記載の方法。 (項目198) 前記近位部分は、第2の自己拡張超弾性材料を備える、項目195~197のいずれか1項に記載の方法。 (項目199) 前記第1の構成要素および前記第2の構成要素は、相互との共通のフレームから一体的に形成されている、項目111~137または165のいずれか1項に記載のデバイス。 (項目200) 前記第1の構成要素および前記第2の構成要素は、相互との共通のフレームから一体的に形成されている、項目155~159、160~164、または166~170のいずれか1項に記載の方法。 (項目201) 前記先端、前記縮小領域、および前記拡大領域は、相互との共通のフレームから一体的に形成されている、項目171~174のいずれか1項に記載のダイレータ。 (項目202) 前記左心房ディスク、前記右心房ディスク、および前記マルテンサイト形状記憶材料は、相互との共通のフレームから一体的に形成されている、項目179~182のいずれか1項に記載のゲート。 (項目203) 前記左心房ディスク、前記右心房ディスク、および前記マルテンサイト形状記憶材料は、相互との共通のフレームから一体的に形成されている、項目183~190のいずれか1項に記載の方法。 (項目204) 前記近位部分、前記遠位部分、および前記中間部分は、相互との共通のフレームから一体的に形成されている、項目191~194のいずれか1項に記載の装置。 (項目205) 前記近位部分、前記遠位部分、および前記中間部分は、相互との共通のフレームから一体的に形成されている、項目195~198のいずれか1項に記載の方法。

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Abstract

A device with internal dimensions that can be reduced and increased in vivo is provided. In one embodiment, an interatrial shunt for placement in the atrial septum of a patient's heart includes a body. The body includes first and second regions fluidly coupled by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between the first and second atria. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. The flow area of ​​the passageway through the neck region can be adjusted in vivo.
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Description

[Technical Field]

[0001] Cross-reference of related applications This application is a continuation in part of U.S. Patent Application No. 17 / 092,081, filed on November 6, 2020, entitled “Devices With Dimensions That Can Be Reduced and Increased In Vivo, and Methods Of Making and Using The Same,” which is a continuation in part of U.S. Patent Application No. 16 / 875,652, filed on May 15, 2020, entitled “Devices With Dimensions That Can Be Reduced and Increased In Vivo, and Methods Of Making and Using The Same,” which is a continuation in part of U.S. Patent Application No. 63 / 019,777, filed on May 4, 2020, entitled “Devices With Dimensions That Can Be Reduced and Increased In Vivo, and Methods Of Making and Using The Same,” the entire contents of each of these are incorporated herein by reference.

[0002] This application generally relates to devices for use in the human body, such as percutaneously implanted devices and methods for regulating the flow of fluids such as blood within the human body. [Background technology]

[0003] In some medical conditions, for example, there is a benefit in regulating the flow of fluids within the human body through a passage between two body cavities. Such passages are typically used in catheterization procedures, where the catheter is delivered through the patient's vascular system. In some catheterization procedures, there is a benefit in moving from one cavity to another by creating a passage. For example, such a passage may be formed between the right and left sides of the heart, for example, from the right atrium to the left atrium, and the clinical procedure is performed on the left side of the heart using an entry from the right side of the heart. Such clinical procedures include, for example, arrhythmia ablation procedures in left atrial and mitral valve repair activity.

[0004] In addition, passages may be created and maintained within the cardiac wall between two ventricles to house shunts that redistribute blood from one ventricle to another in order to address pathologies such as heart failure (HF), myocardial infarction (MI), and pulmonary hypertension (PAH). HF is a physiological condition in which cardiac output is insufficient to meet the body's needs, or does so only at higher filling pressures. There are many underlying causes of HF, including MI, coronary artery disease, valvular heart disease, hypertension (such as PAH), and myocarditis. Chronic heart failure is associated with alterations in neurohormonal activation and autonomic regulation. While these compensatory neurohormonal mechanisms provide valuable support for the heart under normal physiological conditions, they also play a fundamental role in the onset and subsequent progression of HF.

[0005] HF is generally classified as either systolic heart failure ("SHF") or diastolic heart failure ("DHF"). In SHF, the cardiac output is reduced or weakened. The common clinical measure is the ejection fraction, which is a function of the blood ejected out of the left ventricle (stroke volume) divided by the maximum volume of blood ejected from the left ventricle at the end of diastole or lapse. A normal ejection fraction is greater than 50%. Systolic heart failure generally results in a reduced ejection fraction of less than 40%. Such patients have heart failure with a reduced ejection fraction ("HFrEF"). Patients with HFrEF may typically have a larger left ventricle due to a phenomenon called "cardiac remodeling," which secondarily results from higher ventricular pressure.

[0006] In DHF, the heart generally contracts well with a normal ejection fraction, but is stiffer or less responsive than a healthy heart when it relaxes and is filled with blood. Such patients are said to have heart failure with preserved ejection fraction ("HFpEF"). This stiffness can prevent blood from filling the heart, creating stasis in the lungs, which can lead to pulmonary vein hypertension and pulmonary edema. HFpEF is more common in patients over 75 years of age, especially in women with hypertension.

[0007] Both atypical forms of HF are treated using pharmacological approaches, which typically involve the use of vasodilators to reduce cardiac workload by lowering systemic vascular resistance, as well as diuretics to prevent fluid accumulation and edema formation and reduce cardiac filling pressure. While no pharmacological therapies have been shown to improve morbidity or mortality in HFpEF, several classes of drugs, including renin-angiotensin antagonists, neprilysin inhibitors, beta-blockers, mineralocorticoid antagonists, and sodium-glucose cotransporter-2 (SGLT2) inhibitors, have had a significant impact on the management of patients with HFrEF. Nevertheless, HF generally remains a progressive disease, with the majority of patients experiencing worsening cardiac function and symptoms over time. In the United States, there are over one million hospitalizations annually due to acute exacerbations of HF, and its mortality rate is higher than that of most forms of cancer.

[0008] In more severe cases of HFrEF, mechanical circulatory support (MCS) devices, such as mechanical pumps, are used to reduce the load on the heart by performing all or part of the pumping function normally performed by the heart. Chronic left ventricular assist devices ("LVADs"), total heart replacements, and heart transplants are used as last resort. However, such assist devices are typically intended to improve the heart's pumping capacity, increasing cardiac output to a level compatible with a normal lifespan, and sustaining the patient until a donor heart for transplantation becomes available. The use of this MCS is also known as "transplant bridging" therapy. Because the supply of donor hearts for transplantation is insufficient to meet the demand, more often than not, MCS, also known as "implantable ventricular assist devices," is the only therapeutic option. Such mechanical devices allow for the pumping of a significant volume of blood (liters / min), but are limited by the need for a power source, relatively large pumps, and present risks of hemolysis, thrombosis, and infection. Temporary assist devices, intra-aortic balloons, and pacing devices are also used.

[0009] Various devices have been developed that use stents to modify blood pressure and fluid flow within a given vascular or interventricular region. For example, Ruiz's U.S. Patent No. 6,120,534 (Patent Document 1) concerns an intracavitary stent for regulating fluid flow through a body vascular or organ, for example, regulating blood flow through the pulmonary artery and treating congenital heart defects. The stent may include an expandable mesh having balloon-expandable lobes or conical portions joined by a shape-memory converging region, which restricts fluid flow through the stent. The converging region may be regulated in vivo and, in addition, may be heated to restore maximum convergence. Ruiz does not mention the treatment of HF or reduction of left atrial pressure.

[0010] McNamara's U.S. Patent Publication 2013 / 0178784 (Patent Document 2) describes an adjustable pressure relief shunt that can be expanded, for example, via an inflatable balloon. The tubular body of the shunt can be plastically deformed in vivo so that the size of the shunt can be repeatedly adjusted in response to measurements of the patient's physiological parameters by various mechanisms, such as an elastically wound spring or a series of claws and a unidirectional mechanical bevel. A significant drawback of the approach described in that patent is the hysteresis effect, i.e., the irreversible change in the underlying crystalline structure that occurs when the shunt is permanently deformed. Importantly, such plastic deformation can lead to stress and fatigue-related fracture of the device.

[0011] U.S. Patent No. 6,468,303 (Patent Document 3) by Amplatz et al. describes a collapsible medical device and associated method for shunting selected organs and blood vessels. Amplatz explains that the device may be suitable for shunting a septal defect in a patient's heart by creating a shunt within the atrial septum of a neonatal with hypoplastic left heart syndrome ("HLHS"). The patent also explains that it increases the mixing of pulmonary and systemic venous blood and improves oxygen saturation, and that the shunt can later be closed with an occlusion device. Amplatz does not mention means for treating HF or reducing left atrial pressure or for regulating the rate of blood flow through the device.

[0012] Implantable interatrial shunt devices are commonly used in patients with severe symptomatic heart failure. By bypassing or shunting blood from the left atrium ("LA") to the right atrium ("RA"), the pressure in the left atrial is reduced or prevented from rising to the levels that would otherwise occur (left atrial decompression). Such a procedure is expected to prevent, alleviate, or limit the symptoms, signs, and associated syndromes of pulmonary stasis. These include severe shortness of breath, pulmonary edema, hypoxia, the need for emergency hospitalization, mechanical ventilation, and death.

[0013] Shunt flow is generally controlled by the pressure gradient between the atria and the hydromechanical properties of the shunt device. The latter is typically influenced by the shunt's geometry and material composition. For example, the general fluidity of similar shunt designs has been shown to be related to the mean interatrial pressure gradient and the effective orifice diameter.

[0014] Percutaneous implantation of an interatrial shunt generally requires transseptal catheterization immediately before shunt device insertion. The transseptal catheterization system is generally placed from an entry site in the femoral vein, traversing the interatrial septum within the fossa ovale ("FO"), the central and thinnest region of the interatrial septum. In adults, the FO is typically 15–20 mm in its axial dimension and <3 mm thick, but in some circumstances it can be up to 10 mm thick. LA ventricular access may be achieved using a number of different techniques familiar to those skilled in the art, including, but not limited to, needle puncture, stylet puncture, screw needle puncture, and radiofrequency ablation. The passage between the two atria is inflated to facilitate passage for the shunt device, having the desired orifice size. Inflation is generally performed by advancing a tapered sheath / dilator catheter system or by inflating an angioplasty-type balloon traversing the FO. This is the same common location where a congenital secondary atrial septal defect ("ASD") might be located.

[0015] Dobak, III, U.S. Patent Publication 2005 / 0165344 (Patent Document 4), describes a device for treating heart failure comprising a tubular conduit having an embolic filter or valve, the device being positioned within an opening in the atrial septum of the heart and configured to allow flow from the left atrium into the right atrium. Dobak discloses that the blood shunt may reduce left atrial pressure, thereby preventing pulmonary edema and progressive left ventricular dysfunction and reducing LVEDP. Dobak describes that the device may include deployable retaining struts, such as metal arms, which exert some force on the atrial septum on both sides and clamp or bite the device to the septum.

[0016] In addition, following the implantation of the shunt device into the heart wall, tissue growth, including the endothelium or neointima, typically forms on the device, thereby preventing thrombus formation on the shunt device and narrowing the size of the passage through the device. [Prior art documents] [Patent Documents]

[0017] [Patent Document 1] U.S. Patent No. 6,120,534 [Patent Document 2] U.S. Patent Application Publication No. 2013 / 0178784 [Patent Document 3] U.S. Patent No. 6,468,303 [Patent Document 4] U.S. Patent Application Publication No. 2005 / 0165344 [Summary of the Invention] [Means for Solving the Problems]

[0018] The present invention overcomes the disadvantages of previously known systems and methods by providing a device, as well as a method of fabricating and using the same, that can be enlarged and also has dimensions that can be reduced in vivo.

[0019] In particular, the present invention overcomes the limitations of previously known devices and methods by providing an implantable device with a composite structure that exhibits both superelasticity and shape memory properties at body temperature. Dimensions that can affect blood flow or other intended interactions between the implanted device and its biological host can be repeatedly modified in both directions by mechanically deforming one crystal phase of a shape memory component in one direction and reversing the direction by temperature-induced change of the crystal phase of the shape memory component material back to its original dimensions, significantly simplifying catheter-related procedures.

[0020] On one side, an interatrial shunt for placement in the atrial septum of a patient's heart is provided. The interatrial shunt may include a body having a first and a second region coupled to be in fluid communication by a neck portion region. The body may include a shape memory material. The body may define a passage through the neck portion region for blood to flow between the first atrium and the second atrium. The first and second regions may have superelasticity at body temperature, the neck portion region may have malleability at body temperature, and may include nitinol having an austenite finish temperature (Af) of 45 to 60 °C. The flow area of the passage through the neck portion region may be adjusted in vivo.

[0021] In some embodiments, the first and second regions having superelasticity comprise nitinol having an austenite finish temperature (Af) of 5 to 20 °C. In some embodiments, the neck portion region is mechanically expandable. In some embodiments, the neck portion region is thermally contractible.

[0022] On another side, an interatrial shunt for placement in the atrial septum of a patient's heart is provided for adjustably regulating fluid flow therethrough. The interatrial shunt may include a first expandable end region configured to be placed within the first atrium of the heart. The interatrial shunt may include a second expandable end region configured to be placed within the second atrium of the heart. The first and second expandable end regions may include a self-expanding superelastic material. The interatrial shunt may include a neck portion region between the first and second expandable end regions configured for placement in the atrial septum. The neck portion region may include a malleable shape memory material. The interatrial shunt may define a passage through the neck portion region for blood to flow between the first atrium and the second atrium. The neck portion region may be heat-treated to exhibit shape memory properties different from those of the first and second expandable end regions such that the cross-sectional area of the passage is adjustable in vivo.

[0023] In some embodiments, the malleable shape memory material is configured to expand in vivo such that the passage expands from a cross-sectional area to a second cross-sectional area larger than the original cross-sectional area. In some embodiments, the malleable shape memory material is configured to contract in vivo such that the passage contracts from a second cross-sectional area to a third cross-sectional area smaller than the original cross-sectional area. In some embodiments, the cross-sectional area is 4.9 to 28.3 mm². 2 The second and third cross-sectional areas are 15.9 to 78.6 mm². 2 In some embodiments, the malleable shape memory material comprises nitinol having an austenite termination temperature (Af) of 45–60°C. In some embodiments, the self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of 5–20°C. In some embodiments, the malleable shape memory material is mechanically expandable. In some embodiments, the malleable shape memory material is thermally shrinkable. In some embodiments, the cross-sectional area of ​​the neck portion is smaller than the cross-sectional area of ​​at least one individual of the first and second expandable end regions. In some embodiments, the first and second expandable end regions extend into the first and second atria, respectively, such that the respective ends of the first and second expandable end regions do not come into contact with the atrial septum.

[0024] In some embodiments, the first and second expandable end regions, as well as the neck region, constitute a diabolo-shaped shunt. In some embodiments, the neck region constitutes a cylindrical shunt. In some embodiments, the cylindrical shunt is located outside the diabolo-shaped shunt. In some embodiments, the cylindrical shunt is formed from a malleable shape memory material such that the cylindrical shunt radially constrains the dimensions of the diabolo-shaped shunt in the neck region, and the diabolo-shaped shunt self-expands in the neck region in response to the malleable shape memory material expanding to a second cross-sectional area. In some embodiments, the cylindrical shunt is located inside the diabolo-shaped shunt. In some embodiments, the cylindrical shunt is not directly coupled to the diabolo-shaped shunt and the neck region, and the interatrial shunt further includes a covering material that indirectly and elastically couples the cylindrical shunt to the diabolo-shaped shunt. In some embodiments, contraction of the cylindrical shunt does not cause contraction of the diabolo-shaped shunt in the neck region. In some embodiments, diabolo-shaped and cylindrical shunts are integrally formed from a common frame.

[0025] In some embodiments, the first and second expandable end regions, as well as the neck region, are integrally formed from a common frame. In some embodiments, the first and second expandable end regions, as well as the neck region, are at least partially encased in a biocompatible material.

[0026] In another aspect, an interatrial shunt is provided for regulating fluid flow within a heart having a first atrium, a second atrium, and an atrial septum. The interatrial shunt is a first region comprising a self-expanding superelastic material, configured to be installed in the first atrium, the first region may include a first region that is superelastic at body temperature. The interatrial shunt may include a second region comprising a malleable shape memory material, configured to be installed through an opening in the atrial septum to provide fluid flow from the first atrium to the second atrium. The second region may be malleable at body temperature. The malleable shape memory material may have a first cross-sectional area. The malleable shape memory material may be expandable from the first cross-sectional area to a second cross-sectional area. The malleable shape memory material may be contractible from the second cross-sectional area to a third cross-sectional area.

[0027] In some embodiments, the self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of 5 to 20°C, and the malleable shape memory material comprises nitinol having an austenite termination temperature (Af) of 45 to 60°C. In some embodiments, the malleable shape memory material is mechanically expandable and thermally contractible. In some embodiments, the interatrial shunt further comprises a third region comprising a second self-expanding superelastic material, configured to be placed in a second atrium and coupled to the second region.

[0028] In another aspect, a device is provided for regulating the fluid flow through it in a biologically controlled manner. The device may include a first component comprising a first self-expanding superelastic material. The device may include a second component coupled to the first component and comprising a first malleable shape memory material. The first malleable shape memory material may have a first cross-sectional area. The first malleable shape memory material may be expandable in the biological manner up to a second cross-sectional area. The first malleable shape memory material may be contractible in the biological manner up to a third cross-sectional area.

[0029] In some embodiments, the first self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of less than 37°C. In some embodiments, the Af of the nitinol in the first self-expanding superelastic material is 5 to 20°C. In some embodiments, the first malleable shape memory material comprises nitinol having an austenite termination temperature (Af) greater than 37°C. In some embodiments, the Af of the nitinol in the malleable shape memory material is 45 to 60°C. In some embodiments, the first malleable shape memory material is mechanically expandable. In some embodiments, the first malleable shape memory material is thermally shrinkable. In some embodiments, the first malleable shape memory material is joined to the first self-expanding superelastic material by welding.

[0030] In some embodiments, the device comprises a plurality of molded wires, at least one of which comprises a first malleable shape memory material, and at least one of which comprises a first self-expanding superelastic material. In some embodiments, at least one of the wires comprises both the first malleable shape memory material and the first self-expanding superelastic material. In some embodiments, each of the wires comprises both the first malleable shape memory material and the first self-expanding superelastic material. In some embodiments, each of the molded wires comprises a first end and a second end, the first and second ends being joined to each other using overlapping, welding, or swaged tubing. In some embodiments, the wires are joined to each other using windings or sleeves. In some embodiments, at least one of the sleeves is radiopaque. In some embodiments, each of the sleeves is radiopaque. In some embodiments, at least one of the wires comprises a radiopaque material. In some embodiments, the internal core of the wire comprises a radiopaque material. In some embodiments, the upper layer of the wire comprises a first malleable shape memory material or a first self-expanding superelastic material. In some embodiments, the strands of the wire comprise a first malleable shape memory material or a first self-expanding superelastic material. In some embodiments, the upper layer of the wire comprises a radiopaque material. In some embodiments, the inner core of the wire comprises a first malleable shape memory material or a first self-expanding superelastic material. In some embodiments, the device further includes a covering material that covers at least a portion of at least one of the first and second components. In some embodiments, the covering material is bonded to the first self-expanding superelastic material.

[0031] In some embodiments, the cross-sectional area of ​​the first is smaller than the cross-sectional area of ​​the third. In some embodiments, the cross-sectional area of ​​the first is larger than the cross-sectional area of ​​the third. In some embodiments, the device further includes a third component comprising a second self-expanding superelastic material coupled to the first and second components. In some embodiments, the first component comprises an inlet, the second component comprises a neck portion, and the third component comprises an outlet fluidly coupled to the inlet via the neck portion. In some embodiments, the cross-sectional area of ​​the neck portion is smaller than the cross-sectional area of ​​at least one individual of the inlet and outlet. In some embodiments, the inlet and outlet confine the device within an opening through the septum between two ventricles in the body, and the neck portion provides a channel for fluid flow between these ventricles. In some embodiments, the cross-sectional area of ​​the neck portion is larger than the cross-sectional area of ​​at least one individual of the inlet and outlet. In some embodiments, the second component is configured to engage with an opening in the human body. In some embodiments, the opening is created through the fossa ovale of the interatrial septum between the right and left atria. The neck portion may be configured to engage with the opening. The inlet may be configured to extend into the right atrium. The outlet may be configured to extend into the left atrium. In some embodiments, the inlet and outlet are provided with flanges, and the neck portion is provided with a flexible longitudinal bar and a sinusoidal ring, the flexible longitudinal bar allowing the flange to fully expand upon deployment, and the sinusoidal ring having sufficient strength to maintain its diameter when the balloon is inflated or heat-deflated.

[0032] In some embodiments, the first component is configured to engage with a lumen in the human body. In some embodiments, the lumen includes a blood vessel, and the first and third components are configured to engage with the blood vessel. In some embodiments, the neck portion is configured to be positioned adjacent to the opening of the blood vessel.

[0033] In some embodiments, the device further includes a third component comprising a second malleable shape memory material coupled to the first and second components. The second malleable shape memory material may have a fourth cross-sectional area, the fourth cross-sectional area allowing for a fourth rate of fluid flow through it. The second malleable shape memory material may be expandable in vivo to a fifth cross-sectional area, the fifth cross-sectional area allowing for a fifth rate of fluid flow through it. The second malleable shape memory material may be contractible in vivo to a sixth cross-sectional area, the sixth cross-sectional area allowing for a sixth rate of fluid flow through it. In some embodiments, the second component comprises an inlet, and the third component comprises an outlet fluidly coupled to the inlet via the first component. In some embodiments, the inlet is configured to engage with a blood vessel in the human body, the first component is configured to engage with a blood vessel, and the outlet is configured to extend into the mouth of the blood vessel. In some embodiments, the device includes a valve located within a second component. The first component may be configured to engage with a blood vessel in the human body, and the second component may extend into the blood vessel. In some embodiments, the second component is located inside the first component.

[0034] In some embodiments, a first component constitutes a diabolo-shaped shunt having a neck portion, and a second component constitutes a structural member surrounding the neck portion. In some embodiments, the structural member constitutes a cylindrical shunt. In some embodiments, the structural member constitutes a compression coil. In some embodiments, the number of times the compression coil winds around the neck portion varies based on the cross-sectional area of ​​the neck portion. In some embodiments, the compression coil is substantially cylindrical. In some embodiments, the structural member constitutes a compression spring. In some embodiments, the number of times the compression spring winds around the neck portion varies based on the cross-sectional area of ​​the neck portion. In some embodiments, the compression spring is diabolo-shaped. In some embodiments, the device further includes a hook connecting the compression spring to the shunt. In some embodiments, the structural member is on the outside of the diabolo-shaped shunt. In some embodiments, a first malleable shape memory material constrains the dimensions of the neck portion radially. In some embodiments, the first malleable shape memory material is in contact with the outer surface of the neck portion radially to constrain the neck portion from self-expanding to a larger dimension. In some embodiments, the neck portion self-expands in response to the expansion of a first malleable shape memory material to a second cross-sectional area. In some embodiments, a structural member exerts a force on the neck portion that varies based on the cross-sectional area of ​​the neck portion. In some embodiments, the device includes a covering material that forms an inner lumen through the first component. In some embodiments, the covering material further forms an outer covering of the first component. In some embodiments, the covering material further forms an outer covering of the second component. In some embodiments, the cylindrical shunt is located inside the diabolo-shaped shunt. In some embodiments, the cylindrical shunt is not directly coupled to the neck portion of the diabolo-shaped shunt, and the device includes a covering material that indirectly and elastically couples the cylindrical shunt to the diabolo-shaped shunt. In some embodiments, contraction of the cylindrical shunt does not cause contraction of the neck portion of the diabolo-shaped shunt. In some embodiments, the neck portion of the diabolo-shaped shunt is self-expandable to a fourth cross-sectional area.In some embodiments, the contraction of the cylindrical shunt to a third cross-sectional area does not change the cross-sectional area of ​​the neck portion.

[0035] In some embodiments, the second component is located inside the first component. In some embodiments, the first malleable shape memory material constrains the dimensions of the first component radially. In some embodiments, the first malleable shape memory material contacts the inner surface of the first component radially to constrain the first component from shrinking to a smaller dimension. In some embodiments, the first component self-shrinks in response to the first malleable shape memory material shrinking to a third cross-sectional area. In some embodiments, the device includes a covering material that forms the outer covering of the first and second components. In some embodiments, the first and second components are integrally formed from a common frame with respect to each other. In some embodiments, the common frame is substantially cylindrical. In some embodiments, the common frame further comprises a third component comprising a first self-expanding superelastic material. The second component may form the central portion of the common frame. The first and third components may form portions of the common frame configured to extend into the respective atria of the heart. In some embodiments, the second component comprises a groove configured to engage with an opening through the atrial septum. In some embodiments, the first and third components are expanded.

[0036] In some embodiments, the fluid is blood.

[0037] Under another aspect, a method for retrieving a device from the atrial septum of the heart is provided. The method may include positioning a retrieval catheter through the device, the retrieval catheter having a tip and a cup positioned therein. The method may include retracting the cup to the right atrium of the heart while the tip remains in the left atrium of the heart, leaving a space between the tip and the cup that coincides with the position of the device. The method may include heating the device and shrinking it into a heat-set configuration. The method may include retracting the tip and drawing the shrunk device into the cup. The method may include retrieving the retrieval catheter from the heart with the shrunk device at least partially inside each of the tip and the cup.

[0038] Under another aspect, a method for preparing the device is provided. This method may use localized heat treatment of one or more portions of each such device to produce a different austenite finish (Af) temperature from the unheated portion(s) of the device. In some embodiments, the localized heating of one or more portions of the device is carried out using induction heating, with optional active cooling of adjacent areas. In some embodiments, the localized heating of one or more portions of the device is carried out using localized laser heating, with optional active cooling of adjacent areas.

[0039] Under another aspect, a method for preparing a device is provided. This method may include providing wires having different austenite finish (Af) temperatures from each other, and / or wires having different Af temperatures along the length of the wire. This method may also include using the wires to manufacture a device such that the device has multiple Af temperatures.

[0040] In some embodiments, different Af temperatures correspond to different phases of nitinol. In some embodiments, the fabrication of the device using wire involves using wire winding techniques, wire mesh techniques, or any preferred combination thereof.

[0041] In another aspect, an interatrial shunt for placement in the atrial septum of a patient's heart is provided herein. The interatrial shunt includes a body comprising first and second regions coupled to each other by a neck region to be in fluid communication. The body comprises a shape memory material. The body defines a passage through the neck region for blood to flow between the first and second atria. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. The fluid area of ​​the passage through the neck region may be regulated in vivo.

[0042] The first and second superelastic regions may contain nitinol having an austenite termination temperature (Af) of 5 to 20°C. The malleable neck region may contain nitinol having an austenite termination temperature (Af) of 45 to 60°C. The neck region may be mechanically expandable. The neck region may be thermally shrinkable.

[0043] In another aspect, an interatrial shunt is provided for placement in the atrial septum of a patient's heart to allow for regulated fluid flow through it. The interatrial shunt may include a first expandable end region configured to be placed in the first atrium of the heart and a second expandable end region configured to be placed in the second atrium of the heart. The first and second expandable end regions may include a self-expanding superelastic material. The interatrial shunt may include a neck region between the first and second expandable end regions. The neck region may be configured for placement in the atrial septum. The neck region may include a malleable shape memory material. The interatrial shunt may define a passage through the neck region for blood to flow between the first and second atria. The neck region may be heat-treated to exhibit different shape memory properties from the first and second expandable end regions so that the cross-sectional area of ​​the passage is regulated in vivo.

[0044] The malleable shape memory material may be configured to expand in vivo such that the passage expands from one cross-sectional area to a second cross-sectional area larger than the first. The malleable shape memory material may also be configured to contract in vivo such that the passage contracts from the second cross-sectional area to a third cross-sectional area smaller than the second. The cross-sectional area is 4.9 to 28.3 mm². 2 It may also be the case that the second and third cross-sectional areas are 15.9 to 78.6 mm². 2The malleable shape memory material may contain nitinol having an austenite termination temperature (Af) of 45 to 60°C. The self-expanding superelastic material may contain nitinol having an austenite termination temperature (Af) of 5 to 20°C. The malleable shape memory material may be mechanically expandable. The malleable shape memory material may be thermally shrinkable. The cross-sectional area of ​​the neck portion may be smaller than the cross-sectional area of ​​at least one individual of the first and second expandable end regions. The first and second expandable end regions may extend into the first and second atria, respectively, such that the respective ends of the first and second expandable end regions do not come into contact with the atrial septum. The first and second expandable end regions, as well as the neck portion region, may constitute a diabolo-shaped shunt. The neck portion region may include a cylindrical shunt. The cylindrical shunt may be located outside the diabolo-shaped shunt. The cylindrical shunt may be formed from a malleable shape memory material such that the cylindrical shunt radially constrains the dimensions of the diabolo-shaped shunt in the neck region, and the diabolo-shaped shunt may self-expand in the neck region in response to the malleable shape memory material expanding to a second cross-sectional area. The cylindrical shunt is located inside the diabolo-shaped shunt, which may be a diabolo-shaped shunt. The cylindrical shunt does not have to be directly coupled to the diabolo-shaped shunt and the neck region. The device may further include a covering material that indirectly and elastically bonds the cylindrical shunt to the diabolo-shaped shunt. Contraction of the cylindrical shunt does not have to cause contraction of the diabolo-shaped shunt in the neck region. The diabolo-shaped shunt and the cylindrical shunt may be formed integrally from a common frame. The first and second expandable end regions, as well as the neck region, may be formed integrally from a common frame. The first and second expandable end regions, as well as the neck region, may be covered with at least partially biocompatible material.

[0045] In another aspect, an interatrial shunt is provided for regulating the fluid flow within a heart having a first atrium, a second atrium, and an atrial septum. The interatrial shunt may include a first region comprising a self-expanding superelastic material configured to be installed in the first atrium. The first region may be superelastic at body temperature. The interatrial shunt may also include a second region comprising a malleable shape memory material configured to be installed through an opening in the atrial septum to provide fluid flow from the first atrium to the second atrium. The second region may be malleable at body temperature. The malleable shape memory material may have a first cross-sectional area. The malleable shape memory material may be expandable from the first cross-sectional area to a second cross-sectional area. The malleable shape memory material may be contractible from the second cross-sectional area to a third cross-sectional area.

[0046] The self-expanding superelastic material may contain nitinol having an austenite termination temperature (Af) of 5 to 20°C, and the malleable shape memory material may contain nitinol having an austenite termination temperature (Af) of 45 to 60°C. The malleable shape memory material may be mechanically expandable and thermally contractible. The interatrial shunt may include a third region, the third region comprising the second self-expanding superelastic material, configured to be placed in a second atrium, and coupled to the second region.

[0047] In another aspect, a device is provided for regulating the fluid flow through it. The device may include a first component comprising a first self-expanding superelastic material, and a second component coupled to the first component and comprising a first malleable shape memory material. The first malleable shape memory material may have a first cross-sectional area. The first malleable shape memory material may be expandable to a second cross-sectional area. The first malleable shape memory material may be contractible to a third cross-sectional area.

[0048] In some embodiments, the first self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) below body temperature (typically about 37°C). For example, the Af of the nitinol in the first self-expanding superelastic material may be 5 to 20°C.

[0049] In some embodiments, the first malleable shape memory material comprises nitinol having an austenite termination temperature (Af) above body temperature or 37°C. For example, the Af of the nitinol in the malleable shape memory material may be 45-60°C. This is higher than body temperature when thermal, but not high enough to cause permanent damage such as protein denaturation from short exposure.

[0050] In some embodiments, the first malleable shape memory material is mechanically expandable. In some embodiments, the first malleable shape memory material is thermally shrinkable. In some embodiments, the first malleable shape memory material is joined to the first self-expanding superelastic material by welding.

[0051] In some embodiments, the device includes a covering material that covers at least a portion of at least one of the first and second components. Optionally, the covering material is formed by joining a first malleable shape memory material to a first self-expanding superelastic material.

[0052] In some embodiments, the first cross-sectional area is smaller than the third cross-sectional area. In some embodiments, the first cross-sectional area is larger than the third cross-sectional area.

[0053] In some embodiments, the device further includes a third component comprising a second self-expanding superelastic material coupled to the first and second components. Optionally, the first component includes an inlet, the second component includes a neck portion, and the third component includes an outlet fluidly coupled to the inlet via the neck portion. As a further option, the cross-sectional area of ​​the neck portion is smaller than the cross-sectional area of ​​at least one of the individual inlet and outlet portions. As yet another option, the inlet and outlet confine the device within an opening through the septum between two ventricles in the body, with the neck portion providing a channel for fluid flow between these ventricles. In yet another option, the cross-sectional area of ​​the neck portion is larger than the cross-sectional area of ​​at least one of the individual inlet (blood flow inlet) and outlet (blood flow outlet). Optionally, the second component is configured to engage with an opening in the human body. As yet another option, the opening is created through the fossa ovale of the interatrial septum between the right and left atria, which may be a right atrium and a left atrium. The neck portion may be configured to engage with the opening, the inlet may be configured to extend into the right atrium, and the outlet may be configured to extend into the left atrium.

[0054] In some embodiments, the first component is configured to engage with a lumen in the human body. Optionally, the lumen includes a blood vessel, and the first and third components are configured to engage with the blood vessel. The neck portion may be configured to be positioned adjacent to the opening of the blood vessel.

[0055] In some embodiments, the device includes a third component, the third component including a second malleable shape memory material, coupled to the first and second components. Optionally, the second malleable shape memory material has a fourth cross-sectional area that allows for a fourth rate of fluid flow through it. The second malleable shape memory material may be expandable up to a fifth cross-sectional area, the fifth cross-sectional area allowing for a fifth rate of fluid flow through it. The second malleable shape memory material may be contractible up to a sixth cross-sectional area, the sixth cross-sectional area allowing for a sixth rate of fluid flow through it. Optionally, the second component includes an inlet, and the third component includes an outlet that is fluidically coupled to the inlet via the first component. As a further option, the inlet is configured to engage with a blood vessel in the human body, the first component is configured to engage with a blood vessel, and the outlet is configured to extend into the mouth of the blood vessel.

[0056] In some embodiments, the device further includes a valve located within a second component. The first component may be configured to engage with a blood vessel in the human body, and the second component may extend into the blood vessel.

[0057] In some embodiments, the second component is located inside the first component.

[0058] In some embodiments, the first component includes a neck portion having a diabolo-shaped shunt, and the second component includes a cylindrical shunt. Optionally, the cylindrical shunt is located outside the diabolo-shaped shunt. As a further option, the first malleable shape memory material may constrain the dimensions of the neck portion radially. The first malleable shape memory material optionally contacts the outer surface of the neck portion radially to constrain the neck portion from self-expanding to a larger dimension. Optionally, the neck portion self-expands in response to the first malleable shape memory material expanding to a second cross-sectional area. The device optionally further includes a covering material that forms an inner lumen through the first component and an outer covering of the first and second components.

[0059] In other embodiments, the cylindrical shunt is located inside the diabolo-shaped shunt. Optionally, the cylindrical shunt is located inside the neck portion of the diabolo-shaped shunt and is not directly coupled to it. The device optionally further includes a covering material that indirectly and elastically connects the cylindrical shunt to the diabolo-shaped shunt such that the covering material forms a lumen through the inner cylindrical shunt. Optionally, contraction of the cylindrical shunt does not cause contraction of the neck portion of the outer diabolo-shaped shunt. Optionally, the neck portion of the diabolo-shaped shunt is self-expandable up to a fourth cross-sectional area.

[0060] In some embodiments, the second component is located inside the first component. Optionally, the first malleable shape memory material constrains the dimensions of the first component radially. Optionally, the first malleable shape memory material is in contact with the inner surface of the first component radially to constrain the first component from shrinking to a smaller dimension. Optionally, the first component self-shrinks in response to the first malleable shape memory material shrinking to a third cross-sectional area. Optionally, the device further includes a covering material that forms the outer covering of the first and second components.

[0061] In another aspect, a method is provided for reducing and increasing the internal dimensions of a device in a living organism. This method may include inserting first and second interconnected components into a flow channel. The first component may include a self-expanding superelastic material, and the second component may include a malleable shape memory material having a first cross-sectional area. This method may include expanding the malleable shape memory material to a second cross-sectional area and contracting the malleable shape memory material to a third cross-sectional area.

[0062] In some embodiments, shrinking the malleable shape memory material includes heating the malleable shape memory material. In some embodiments, heating includes flowing heated saline solution through the device via a catheter. In some embodiments, heating includes applying radio frequency (RF) energy to the device. In some embodiments, expanding the malleable shape memory material includes expanding a balloon within the malleable shape memory material.

[0063] In another aspect, a method for regulating fluid flow is provided. This method may include inserting first and second components, which are coupled to each other, into a flow path. The first component may include a self-expanding hyperelastic material, and the second component may include a malleable shape memory material having a first cross-sectional area and allowing a first rate of fluid flow through it. This method may include expanding the malleable shape memory material to a second cross-sectional area that allows a second rate of fluid flow through it, and contracting the malleable shape memory material to a third cross-sectional area that allows a third rate of fluid flow through it.

[0064] In some embodiments, shrinking the malleable shape memory material includes heating the malleable shape memory material. In some embodiments, heating includes flowing heated saline solution through the device via a catheter. In some embodiments, heating includes applying radio frequency (RF) energy to the device. In some embodiments, expanding the malleable shape memory material includes expanding a balloon within the malleable shape memory material.

[0065] In another aspect, a repositionable device for fixation within a body lumen is provided. The device may include a first component comprising a self-expanding superelastic material and a second component coupled to the first component and comprising a malleable shape memory material. The self-expanding superelastic material may have a predetermined fully expanded dimension. The second component may have a first dimension suitable for deployment through a catheter. The malleable shape memory material may be expandable to a second dimension for fixation within a body lumen. The malleable shape memory material may be thermally transitionable to a third dimension. The malleable shape memory material may be mechanically re-expandable to a fourth dimension.

[0066] Under another aspect, a method is provided for adjustably securing a device within a body lumen. The method may include inserting a device into a body lumen, the device comprising first and second components coupled together. The first component may include a self-expanding superelastic material. The second component may include a malleable shape memory material having a first dimension. The method may include expanding the malleable shape memory material to a second dimension to secure the device within the body lumen. The method may also include thermally shrinking the malleable shape memory material. The method may include repositioning the device within the body lumen while the malleable shape memory material is thermally shrinking. The method may also include mechanically re-expanding the malleable shape memory material to a third dimension to secure the device within the body lumen.

[0067] In some embodiments, thermally shrinking a malleable shape memory material includes heating the malleable shape memory material. In some embodiments, heating includes flowing heated saline solution through a catheter into the device. In some embodiments, heating includes applying radio frequency (RF) energy to the device. In some embodiments, mechanically expanding a malleable shape memory material includes expanding a balloon within the malleable shape memory material.

[0068] In any of the aforementioned devices and methods, the first and second components are optionally formed integrally from a common frame with respect to each other.

[0069] In another aspect, a dilator is provided for enlarging an opening through a region of the human body. The dilator may include a sheath having a proximal and distal end, and a dilator positioned at the distal end of the sheath, including a tip, an enlargement region, and a reduction region. The reduction region may be sized to engage securely with the distal end of the sheath. The enlargement region may be sized to provide a smooth profile between the sheath and the tip. The distal end of the tip may be tapered to nearly a point. At least the enlargement and reduction regions may include a martensitic shape memory material having an austenite termination temperature (Af) substantially above 37°C, thereby, upon application of heat within the body, the shape memory material returns to smaller heat-set outer dimensions such that the dilator has a substantially smooth reduced size profile.

[0070] In some embodiments, the tip also includes a martensitic shape memory material. In some embodiments, the tip includes a self-expanding hyperelastic material. The tip, the contraction region, and the expansion region are optionally formed integrally from a common frame with respect to each other.

[0071] In another aspect, a system is provided that includes such a dilator and a device that deploys within the opening.

[0072] In another aspect, a method is provided for forming an enlarged opening through a region of the human body. This method may include positioning a guidewire through a region of the human body to form an opening. This method may also include pushing a dilator through the opening via the guidewire to form an enlarged opening. This method may also include heating the dilator to reduce its size. This method may also include removing the dilator through the enlarged opening while the dilator has reached its reduced size.

[0073] In some embodiments, heating includes flowing heated saline solution through a catheter to a dilator. In some embodiments, heating includes applying radio frequency (RF) energy to the dilator. In some embodiments, the method includes deploying the device within the opening and withdrawing the dilator through the device.

[0074] In another aspect, a transatrial gate is provided. The transatrial gate may include a left atrial disk comprising a first self-expanding superelastic material and a right atrial disk comprising a second self-expanding superelastic material. The transatrial gate may also include a martensitic shape memory material that is heat-set to completely occlude the passage between the left and right atrial disks, which is expandable to allow passage between the left and right atrial disks.

[0075] In some embodiments, the martensite shape memory material is provided as a mesh. In some embodiments, the martensite shape memory material is balloon expandable. In some embodiments, the martensite shape memory material is configured to be expandable to allow passage between the left and right atrial disks, and then closable by the application of heat. The left atrial disk, the right atrial disk, and the martensite shape memory material are optionally formed integrally from a common frame with respect to each other.

[0076] In another aspect, a method for carrying out the procedure is provided. This method may include implanting a transatrial gate through an opening in the atrial septum of the heart. The transatrial gate may include a left atrial disk comprising a first self-expanding superelastic material and a right atrial disk comprising a second self-expanding superelastic material. The transatrial gate may also include a martensite shape memory material that is heat-set to completely occlude the passage between the left and right atrial disks. This method may also include expanding the martensite shape memory material to allow passage between the left and right atrial disks.

[0077] In some embodiments, the material includes blood. In some embodiments, the material includes an instrument. In some embodiments, the method includes performing an additional procedure in the left atrium of the heart using the instrument. In some embodiments, the additional procedure includes RF ablation, left atrial appendage closure, MitraClip implantation, mitral valve replacement, or mitral valve repair. In some embodiments, the martensite shape memory material is provided as a mesh. In some embodiments, the martensite shape memory material is expanded using a balloon. In some embodiments, the method further includes closing the martensite shape memory material by applying heat after expansion. The left atrial disk, the right atrial disk, and the martensite shape memory material are optionally formed integrally from a common frame with respect to each other.

[0078] Under yet another aspect, an apparatus is provided. The apparatus includes a device comprising a proximal portion configured to be positioned within the first atrium of the heart, and a distal portion configured to be positioned within the second atrium of the heart, comprising a first self-expanding superelastic material. The device further includes an intermediate portion positioned between the proximal and distal portions and configured to be positioned within the atrial septum between the first and second atria. The intermediate portion comprises a malleable shape-memory material. The apparatus further includes a catheter and at least one converging flexible longitudinal element. The first self-expanding superelastic material may have a predetermined fully expanded dimension. The intermediate portion may have a first dimension suitable for deployment through the catheter, may be expandable to a second dimension for fixation within the septum, may be thermally transitionable to a third dimension, and may be mechanically re-expandable to a fourth dimension. The device may be removable by pulling the device into the catheter using at least one converging flexible longitudinal element.

[0079] In some embodiments, the proximal portion is expanded. In some embodiments, the distal portion is expanded. In some embodiments, the proximal portion includes a second self-expanding hyperelastic material. The proximal portion, distal portion, and intermediate portion are optionally formed integrally from a common frame with respect to each other.

[0080] In another aspect, a method is provided which involves deploying a device through a catheter through the atrial septum of the heart. The device may include a proximal portion located in the first atrium of the heart and a distal portion located in the second atrium of the heart and comprising a first self-expanding superelastic material. The device may include an intermediate portion located between the proximal and distal portions and situated in the atrial septum between the first and second atria. The intermediate portion may comprise a malleable shape memory material. The first self-expanding superelastic material may have a predetermined fully expanded dimension. The intermediate portion may have a first dimension when deployed through a catheter. The method may include expanding the intermediate portion to a second dimension for fixation within the septum. The method may include thermally transitioning the intermediate portion to a third dimension. The method may include mechanically re-expanding the intermediate portion to a fourth dimension. The method may include removing the device by pulling it into the catheter using at least one converging flexible longitudinal element.

[0081] In some embodiments, the proximal portion is expanded. In some embodiments, the distal portion is expanded. In some embodiments, the proximal portion includes a second self-expanding hyperelastic material. The proximal portion, distal portion, and intermediate portion are optionally formed integrally from a common frame with respect to each other. The present invention provides, for example, the following: (Item 1) An interatrial shunt for placement in the atrial septum of the patient's heart, The interatrial shunt comprises a body having first and second regions connected by a neck region to be in fluid communication, the body comprising a shape memory material and defining a passage through the neck region for blood to flow between the first atrium and the second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature and comprises nitinol having an austenite termination temperature (Af) of 45-60°C. The flow area of ​​the passage through the aforementioned neck region can be regulated within the body. Interatrial shunt. (Item 2) The interatrial shunt according to item 1, wherein the first and second superelastic regions comprise nitinol having an austenite termination temperature (Af) of 5 to 20°C. (Item 3) The aforementioned neck region is a mechanically expandable interatrial shunt as described in item 1 or item 2. (Item 4) The aforementioned neck region is a thermally contractible interatrial shunt as described in any one of items 1 to 3. (Item 5) An interatrial shunt for placement in the atrial septum of a patient's heart, wherein the interatrial shunt is configured to allow for adjustable control of fluid flow through it, A first expandable end region configured to be installed within the first atrium of the heart, A second expandable end region configured to be installed within the second atrium of the heart, wherein the first and second expandable end regions comprise a self-expanding superelastic material, and the second expandable end region comprises A neck region between the first and second expandable end regions, configured for placement in the atrial septum, wherein the neck region comprises a malleable shape memory material, and the interatrial shunt defines a passage through the neck region for blood to flow between the first atrium and the second atrium. An interatrial shunt comprising, wherein the neck portion region is heat-treated to exhibit different shape-memory properties from the first and second expandable end regions, so that the cross-sectional area of ​​the passage can be adjusted in vivo. (Item 6) The interatrial shunt according to item 5, wherein the malleable shape memory material is configured to expand in vivo so that the passage expands from the cross-sectional area to a second cross-sectional area larger than the cross-sectional area. (Item 7) The interatrial shunt according to item 6, wherein the malleable shape memory material is configured to be contracted in vivo so that the passage contracts from a second cross-sectional area to a third cross-sectional area smaller than the second cross-sectional area. (Item 8) The aforementioned cross-sectional area is 4.9 to 28.3 mm². 2 The second and third cross-sectional areas are 15.9 to 78.6 mm². 2 This refers to the interatrial shunt described in item 7. (Item 9) The malleable shape memory material comprises nitinol having an austenite termination temperature (Af) of 45 to 60°C, as described in any one of items 5 to 8. (Item 10) The self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of 5 to 20°C, as described in any one of items 5 to 9. (Item 11) The malleable shape-memory material is a mechanically expandable interatrial shunt as described in any one of items 5 to 10. (Item 12) The malleable shape memory material is thermally shrinkable, as described in any one of items 5 to 11, for the interatrial shunt. (Item 13) An interatrial shunt according to any one of items 5 to 12, wherein the cross-sectional area of ​​the neck portion is smaller than the cross-sectional area of ​​at least one individual of the first and second expandable end regions. (Item 14) An interatrial shunt according to any one of items 5 to 13, wherein the first and second expandable end regions extend into the first and second atria, respectively, such that the respective ends of the first and second expandable end regions do not come into contact with the atrial septum. (Item 15) The interatrial shunt according to any one of items 5 to 14, wherein the first and second expandable end regions and the neck region constitute a diabolo-shaped shunt. (Item 16) The aforementioned neck region constitutes a cylindrical shunt, as described in item 15. (Item 17) The cylindrical shunt is an interatrial shunt as described in item 16, located outside the diabolo-shaped shunt. (Item 18) The interatrial shunt according to item 17, wherein the cylindrical shunt is formed from the malleable shape memory material such that the cylindrical shunt constrains the dimensions of the diabolo-shaped shunt in the neck region in the radial direction, and the diabolo-shaped shunt self-expands in the neck region in response to the malleable shape memory material expanding to a second cross-sectional area. (Item 19) The cylindrical shunt is an interatrial shunt as described in item 16, located inside the diabolo-shaped shunt. (Item 20) The interatrial shunt according to item 16, wherein the cylindrical shunt is not directly connected to the diabolo-shaped shunt and the neck region, but further comprises an encapsulating material that indirectly and elastically connects the cylindrical shunt to the diabolo-shaped shunt. (Item 21) The interatrial shunt according to item 16, wherein the contraction of the cylindrical shunt does not cause the contraction of the diabolo-shaped shunt in the neck region. (Item 22) The interatrial shunt according to item 16, wherein the diabolo-shaped shunt and the cylindrical shunt are integrally formed from a common frame. (Item 23) The interatrial shunt according to any one of items 5 to 15, wherein the first and second expandable end regions and the neck portion region are integrally formed from a common frame. (Item 24) The interatrial shunt according to any one of items 5 to 15, wherein the first and second expandable end regions, and the neck portion region, are at least partially encased in a biocompatible material. (Item 25) An interatrial shunt for regulating the fluid flow within a heart having a first atrium, a second atrium, and an interatrial septum, wherein the interatrial shunt is A first region comprising a self-expanding superelastic material, configured to be installed within the first atrium, wherein the first region is superelastic at body temperature, A second region comprising a malleable shape memory material, configured to be installed through an opening in the atrial septum to provide fluid flow from the first atrium to the second atrium, wherein the second region is malleable at body temperature and Equipped with, The malleable shape memory material has a first cross-sectional area, The malleable shape memory material is expandable from the first cross-sectional area to the second cross-sectional area, The malleable shape memory material is shrinkable from the second cross-sectional area to the third cross-sectional area. Interatrial shunt. (Item 26) The interatrial shunt according to item 25, wherein the self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of 5 to 20°C, and the malleable shape memory material comprises nitinol having an austenite termination temperature (Af) of 45 to 60°C. (Item 27) The malleable shape memory material is mechanically expandable and thermally contractible, as described in item 25 or item 26, for an interatrial shunt. (Item 28) An interatrial shunt according to any one of items 25 to 27, further comprising a third region comprising a second self-expanding superelastic material, configured to be placed within the second atrium and coupled to the second region. (Item 29) A device for regulating fluid flow through it within a living organism, A first component comprising a first self-expanding superelastic material, A second component is coupled to the first component and comprises a first malleable shape memory material. Equipped with, The first malleable shape memory material has a first cross-sectional area, The first malleable shape memory material is expandable in vivo up to a second cross-sectional area. The first malleable shape memory material is capable of shrinking in vivo to a third cross-sectional area. device. (Item 30) The device according to item 29, wherein the first self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of less than 37°C. (Item 31) The device according to item 30, wherein the Af of the nitinol in the first self-expanding superelastic material is 5 to 20°C. (Item 32) The device according to any one of items 29 to 31, wherein the first malleable shape memory material comprises nitinol having an austenite termination temperature (Af) above 37°C. (Item 33) The device according to item 32, wherein the Af of the nitinol in the malleable shape memory material is 45-60°C. (Item 34) The first malleable shape memory material is a device according to any one of items 29 to 33, which is mechanically expandable. (Item 35) The first malleable shape memory material is thermally shrinkable, as described in any one of items 29 to 34. (Item 36) The device according to any one of items 29 to 35, wherein the first malleable shape memory material is joined to the first self-expanding superelastic material by welding. (Item 37) The device according to any one of items 29 to 36, comprising a plurality of molded wires, at least one of the wires comprising the first malleable shape memory material, and at least one of the wires comprising the first self-expanding superelastic material. (Item 38) The device according to item 37, wherein at least one of the wires comprises both the first malleable shape memory material and the first self-expanding superelastic material. (Item 39) The device according to item 37, wherein each of the wires comprises both the first malleable shape memory material and the first self-expanding superelastic material. (Item 40) The device according to any one of items 37 to 39, wherein each of the molded wires comprises a first end and a second end, the first and second ends being joined to each other using overlapping, welding, or swaged tubing. (Item 41) The wires are coupled to each other using windings or sleeves, as described in any one of items 37 to 40. (Item 42) The device according to item 41, wherein at least one of the sleeves is radiopaque. (Item 43) Each of the aforementioned sleeves is radiopaque, as described in item 41. (Item 44) The device according to any one of items 37 to 43, wherein at least one of the wires comprises a radiopaque material. (Item 45) The device according to item 44, wherein the internal core of the wire comprises the radiopaque material. (Item 46) The device according to item 45, wherein the upper layer of the wire comprises the first malleable shape memory material or the first self-expanding superelastic material. (Item 47) The device according to item 45, wherein the stranded wire comprises the first malleable shape memory material or the first self-expanding superelastic material. (Item 48) The device according to item 45, wherein the upper layer of the wire comprises the radiopaque material. (Item 49) The device according to item 48, wherein the internal core of the wire comprises the first malleable shape memory material or the first self-expanding superelastic material. (Item 50) The device according to any one of items 29 to 49, further comprising a covering material that covers at least a portion of at least one of the first and second components. (Item 51) The device according to item 50, wherein the encapsulated material comprises a first malleable shape memory material joined to a first self-expanding superelastic material. (Item 52) The device according to any one of items 29 to 51, wherein the first cross-sectional area is smaller than the third cross-sectional area. (Item 53) The device according to any one of items 29 to 51, wherein the first cross-sectional area is greater than the third cross-sectional area. (Item 54) The device according to any one of items 29 to 53, further comprising a third component, the third component comprising a second self-expanding superelastic material and coupled to the first component and the second component. (Item 55) The device according to item 54, wherein the first component comprises an inlet, the second component comprises a neck portion, and the third component comprises an outlet fluidly coupled to the inlet via the neck portion. (Item 56) The device according to item 55, wherein the cross-sectional area of ​​the neck portion is smaller than the cross-sectional area of ​​at least one individual of the inlet and outlet. (Item 57) The device according to item 56, wherein the inlet and outlet are located within an opening through the septum between two ventricles in the body, and the neck portion provides a channel for fluid flow between these ventricles. (Item 58) The device according to item 55, wherein the cross-sectional area of ​​the neck portion is greater than the cross-sectional area of ​​at least one individual of the inlet and outlet. (Item 59) The device according to item 55, wherein the second component is configured to engage with an opening in the human body. (Item 60) The aforementioned opening is created through the fossa ovalis of the interatrial septum between the right and left atria, The neck portion is configured to engage with the opening, The aforementioned entrance is configured to extend into the right atrium. The aforementioned outlet is configured to extend into the left atrium. The device described in item 59. (Item 61) The inlet and outlet are equipped with flanges. The neck portion comprises a flexible longitudinal bar and a sinusoidal ring, The flexible longitudinal bar allows the flange to fully expand when deployed. The sinusoidal ring has sufficient strength to maintain its diameter when inflated or deflated by heat. The device described in item 60. (Item 62) The device according to item 55, wherein the first component is configured to engage with a lumen in the human body. (Item 63) The lumen includes blood vessels, The first and third components are configured to engage with the blood vessel. The device described in item 62. (Item 64) The device according to item 63, wherein the neck portion is configured to be positioned adjacent to the opening of the blood vessel. (Item 65) The device according to any one of items 29 to 53, further comprising a third component, the third component comprising a second malleable shape memory material and coupled to the first component and the second component. (Item 66) The second malleable shape memory material has a fourth cross-sectional area, the fourth cross-sectional area enabling a fourth rate of fluid flow through it, The second malleable shape memory material is expandable in vivo to a fifth cross-sectional area, the fifth cross-sectional area enabling a fifth rate of fluid flow through it, The second malleable shape memory material is capable of shrinking in vivo to a sixth cross-sectional area, the sixth cross-sectional area enabling a sixth rate of fluid flow through it. The device described in item 65. (Item 67) The device according to item 65 or 66, wherein the second component comprises an inlet, and the third component comprises an outlet fluidly coupled to the inlet via the first component. (Item 68) The aforementioned entrance is configured to engage with blood vessels within the human body. The first component is configured to engage with the blood vessel, The outlet is configured to extend into the opening of the blood vessel. The device described in item 67. (Item 69) The device further comprises a valve located within the second component, The first component is configured to engage with blood vessels in the human body, The second component extends into the blood vessel, A device described in any one of items 29-53. (Item 70) The second component is located inside the first component, and is a device as described in any one of items 29 to 53. (Item 71) The device according to any one of items 29 to 53, wherein the first component constitutes a diabolo-shaped shunt having a neck portion, and the second component constitutes a structural member surrounding the neck portion. (Item 72) The structural member is the device described in item 71, which constitutes a cylindrical shunt. (Item 73) The structural member is the device described in item 71, which constitutes a compression coil. (Item 74) The device according to item 73, wherein the number of times the compression coil is wound around the neck portion varies based on the cross-sectional area of ​​the neck portion. (Item 75) The device described in item 74, wherein the compression coil is substantially cylindrical. (Item 76) The structural member is the device described in item 71, which constitutes a compression spring. (Item 77) The device according to item 76, wherein the number of times the compression spring wraps around the neck portion varies based on the cross-sectional area of ​​the neck portion. (Item 78) The compression spring is diabolo-shaped, as described in item 77. (Item 79) The device according to any one of items 76 to 78, further comprising a hook connecting the compression spring to the shunt. (Item 80) The structural member is the device described in item 71, located outside the diabolo-shaped shunt. (Item 81) The device according to item 71, wherein the first malleable shape memory material constrains the dimensions of the neck portion in the radial direction. (Item 82) The device according to item 81, wherein the first malleable shape memory material is in contact with the outer surface of the neck portion in the radial direction to restrain the neck portion from self-expanding to a larger dimension. (Item 83) The device according to item 82, wherein the neck portion self-expands in response to the first malleable shape memory material expanding to the second cross-sectional area. (Item 84) The device according to item 71, wherein the structural member exerts a force on the neck portion that varies based on the cross-sectional area of ​​the neck portion. (Item 85) The device according to item 71, further comprising a covering material that forms an inner lumen through the first component. (Item 86) The device according to item 85, wherein the covering material further forms an outer covering of the first component. (Item 87) The device according to item 86, wherein the covering material further forms an outer covering of the second component. (Item 88) The cylindrical shunt is located inside the diabolo-shaped shunt, as described in item 71. (Item 89) The cylindrical shunt is not directly connected to the neck portion of the diabolo-shaped shunt. The device further comprises a covering material that indirectly and elastically connects the cylindrical shunt to the diabolo-shaped shunt. The device described in item 88. (Item 90) The device according to item 89, wherein the contraction of the cylindrical shunt does not cause the contraction of the neck portion of the diabolo-shaped shunt. (Item 91) The device according to item 89, wherein the neck portion of the diabolo-shaped shunt is self-expandable up to a fourth cross-sectional area. (Item 92) The device according to item 91, wherein the contraction of the cylindrical shunt to the third cross-sectional area does not change the cross-sectional area of ​​the neck portion. (Item 93) The second component is located inside the first component, and is a device as described in any one of items 29 to 53. (Item 94) The device according to item 93, wherein the first malleable shape memory material constrains the dimensions of the first component in the radial direction. (Item 95) The device according to item 94, wherein the first malleable shape memory material is in contact with the inner surface of the first component in the radial direction to restrain the first component from shrinking to a smaller dimension. (Item 96) The device according to item 93, wherein the first component self-shrinks in response to the first malleable shape memory material shrinking to the third cross-sectional area. (Item 97) The device according to item 93, further comprising a covering material that forms the outer covering of the first and second components. (Item 98) The device according to item 29, wherein the first component and the second component are integrally formed from a common frame with respect to each other. (Item 99) The common frame is substantially cylindrical, as described in item 98. (Item 100) The common frame further comprises a third component comprising the first self-expanding superelastic material, The second component described above forms the central portion of the common frame, The first and third components form a portion of the common frame that is configured to extend into each of the atria of the heart. Devices as described in item 98 or item 99. (Item 101) The device according to item 100, wherein the second component comprises a groove configured to engage with an opening through the atrial septum. (Item 102) The first and third components are expanded, as described in item 100 or item 101. (Item 103) The fluid is blood, as described in any one of items 29 to 102 of the device. (Item 104) A method for retrieving a device from the atrial septum of the heart, the method being The method involves positioning a retrieval catheter through the aforementioned device, wherein the retrieval catheter has a tip and a cup positioned therein. While the chip remains in the left atrium of the heart, the cup is retracted to the right atrium of the heart, leaving a space between the chip and the cup that coincides with the position of the device. The device is heated and the device is contracted into a heat set configuration. Retracting the chip and pulling the retracted device into the cup, With the contracted device at least partially inside the respective tip and cup, the retrieval catheter is to be retrieved from the heart. Methods that include... (Item 105) A method for preparing a device, the method comprising using localized heat treatment of one or more portions of each such device to produce an Af different from that of the unheated portion(s) of the device. (Item 106) The method according to item 105, wherein the localized heating of one or more portions of the device is carried out using induction heating, optionally accompanied by active cooling of adjacent areas. (Item 107) The method according to item 105, wherein the local heating of the one or more parts of the device is carried out using local laser heating, optionally accompanied by active cooling of adjacent areas. (Item 108) A method for preparing a device, wherein the method is To provide wires having different austenite termination (Af) temperatures from one another, and / or wires having different Af temperatures along the length of the wire, Using the aforementioned wire, the device is manufactured such that it has multiple Af temperatures. Methods that include... (Item 109) The different Af temperatures mentioned above correspond to different phases of nitinol, as described in item 108. (Item 110) Manufacturing the device using the wire is the method according to item 108, which includes using a wire winding technique, a wire mesh technique, or any preferred combination thereof. (Item 111) A device for adjusting the fluid flow through it, A first component comprising a first self-expanding superelastic material, A second component is coupled to the first component and comprises a first malleable shape memory material. Equipped with, The first malleable shape memory material has a first cross-sectional area, The first malleable shape memory material is expandable up to a second cross-sectional area. The first malleable shape memory material is shrinkable to a third cross-sectional area. device. (Item 112) The device according to item 111, wherein the first self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of less than 37°C. (Item 113) The device according to item 112, wherein the Af of the nitinol in the first self-expanding superelastic material is 5 to 20°C. (Item 114) The device according to any one of items 111 to 113, wherein the first malleable shape memory material comprises nitinol having an austenite termination temperature (Af) above 37°C. (Item 115) The device according to item 114, wherein the Af of the nitinol in the malleable shape memory material is 45 to 60°C. (Item 116) The first malleable shape memory material is a device according to any one of items 111 to 115, which is mechanically expandable. (Item 117) The first malleable shape memory material is thermally shrinkable, as described in any one of items 111 to 116. (Item 118) The device according to any one of items 111 to 117, wherein the first malleable shape memory material is joined to the first self-expanding superelastic material by welding. (Item 119) The device according to any one of items 111 to 118, further comprising a covering material that covers at least a portion of at least one of the first and second components. (Item 120) The device according to item 119, wherein the encapsulated material comprises a first malleable shape memory material joined to a first self-expanding superelastic material. (Item 121) A device according to any one of items 111 to 120, wherein the first cross-sectional area is smaller than the third cross-sectional area. (Item 122) The device according to any one of items 111 to 121, wherein the first cross-sectional area is greater than the third cross-sectional area. (Item 123) The device according to any one of items 111 to 122, further comprising a third component, the third component comprising a second self-expanding superelastic material and coupled to the first component and the second component. (Item 124) The device according to item 123, wherein the first component comprises an inlet, the second component comprises a neck portion, and the third component comprises an outlet fluidly coupled to the inlet via the neck portion. (Item 125) The device according to item 124, wherein the cross-sectional area of ​​the neck portion is smaller than the cross-sectional area of ​​at least one individual of the inlet and outlet. (Item 126) The device according to item 125, wherein the inlet and outlet are located within an opening through the septum between two ventricles in the body, and the neck portion provides a channel for fluid flow between these ventricles. (Item 127) The device according to item 124, wherein the cross-sectional area of ​​the neck portion is greater than the cross-sectional area of ​​at least one individual of the inlet and outlet. (Item 128) The device according to any one of items 123 to 127, wherein the second component is configured to engage with an opening in the human body. (Item 129) The aforementioned opening is created through the fossa ovalis of the interatrial septum between the right and left atria, The neck portion is configured to engage with the opening, The aforementioned entrance is configured to extend into the right atrium. The aforementioned outlet is configured to extend into the left atrium. A device as described in item 128, which is subordinate to item 124. (Item 130) The device according to any one of items 111 to 126, wherein the first component is configured to engage with a lumen in the human body. (Item 131) The lumen includes blood vessels, The first and third components are configured to engage with the blood vessel. A device as described in any one of items 111-126, 129, or 130. (Item 132) The device according to item 131, which is subordinate to item 124, wherein the neck portion is configured to be positioned adjacent to the opening of the blood vessel. (Item 133) The device according to any one of items 111 to 122, further comprising a third component, the third component comprising a second malleable shape memory material and coupled to the first component and the second component. (Item 134) The second malleable shape memory material has a fourth cross-sectional area, the fourth cross-sectional area enabling a fourth rate of fluid flow through it, The second malleable shape memory material is expandable up to a fifth cross-sectional area, the fifth cross-sectional area enabling a fifth rate of fluid flow through it, The second malleable shape memory material is shrinkable to a sixth cross-sectional area, the sixth cross-sectional area allowing a sixth rate of fluid flow through it. The device described in item 133. (Item 135) The device according to item 133 or 134, wherein the second component comprises an inlet, and the third component comprises an outlet fluidly coupled to the inlet via the first component. (Item 136) The aforementioned entrance is configured to engage with blood vessels within the human body. The first component is configured to engage with the blood vessel, The outlet is configured to extend into the opening of the blood vessel. The device described in item 135. (Item 137) The second component further comprises a valve located within the second component, The first component is configured to engage with blood vessels in the human body, The second component extends into the blood vessel, A device as described in any one of items 111-122. (Item 138) The second component is located inside the first component, and is a device as described in any one of items 111 to 122. (Item 139) The device according to any one of items 111 to 122, wherein the first component constitutes a diabolo-shaped shunt having a neck portion, and the second component constitutes a cylindrical shunt. (Item 140) The cylindrical shunt is located outside the diabolo-shaped shunt, as described in item 139. (Item 141) The device according to item 140, wherein the first malleable shape memory material constrains the dimensions of the neck portion in the radial direction. (Item 142) The device according to item 141, wherein the first malleable shape memory material is in contact with the outer surface of the neck portion in the radial direction to restrain the neck portion from self-expanding to a larger dimension. (Item 143) The device according to item 141 or 142, wherein the neck portion self-expands in response to the first malleable shape memory material expanding to the second cross-sectional area. (Item 144) The device according to any one of items 140 to 143, further comprising an inner lumen through the first component and a covering material that forms an outer covering of the first component and the second component. (Item 145) The cylindrical shunt is located inside the diabolo-shaped shunt, as described in item 139. (Item 146) The cylindrical shunt is not directly connected to the neck portion of the diabolo-shaped shunt. The device further comprises a covering material that indirectly and elastically connects the cylindrical shunt to the diabolo-shaped shunt. The device described in item 145. (Item 147) The device according to item 146, wherein the contraction of the cylindrical shunt does not cause contraction of the neck portion. (Item 148) The device according to item 146, wherein the neck portion of the diabolo-shaped shunt is self-expandable up to a fourth cross-sectional area. (Item 149) The device according to item 148, wherein the contraction of the cylindrical shunt to the third cross-sectional area does not change the cross-sectional area of ​​the neck portion. (Item 150) The second component is located inside the first component, and is a device as described in any one of items 111 to 122. (Item 151) The device according to item 150, wherein the first malleable shape memory material constrains the dimensions of the first component in the radial direction. (Item 152) The device according to item 151, wherein the first malleable shape memory material is in contact with the inner surface of the first component in the radial direction to restrain the first component from shrinking to a smaller dimension. (Item 153) The device according to any one of items 150 to 152, wherein the first component self-shrinks in response to the first malleable shape memory material shrinking to the third cross-sectional area. (Item 154) The device according to any one of items 150 to 153, further comprising a covering material that forms the outer covering of the first and second components. (Item 155) A method for reducing and increasing the internal dimensions of a device in a living organism, wherein the method is Inserting the mutually connected first and second components into the flow path, The first component described above comprises a self-expanding superelastic material, The second component comprises a malleable shape memory material having a first cross-sectional area. That thing, The malleable shape memory material is extended to a second cross-sectional area, The malleable shape memory material is to be shrunk to a third cross-sectional area. Methods that include... (Item 156) The method according to item 155, wherein shrinking the malleable shape memory material includes heating the malleable shape memory material. (Item 157) The method according to item 156, wherein the heating includes flowing heated saline solution through the device via a catheter. (Item 158) The heating method according to item 156, which includes applying radio frequency (RF) energy to the device. (Item 159) Expanding the malleable shape memory material includes expanding a balloon within the malleable shape memory material, as described in any one of items 155 to 158. (Item 160) A method for adjusting fluid flow in a controllable manner, wherein the method is Inserting the mutually connected first and second components into the flow path, The first component described above comprises a self-expanding superelastic material, The second component comprises a malleable shape memory material having a first cross-sectional area, the first cross-sectional area enabling a first rate of fluid flow through it. That thing, The malleable shape memory material is extended to a second cross-sectional area, wherein the second cross-sectional area enables a second rate of fluid flow through it. The malleable shape memory material is contracted to a third cross-sectional area, wherein the third cross-sectional area allows for a third rate of fluid flow through it. Methods that include... (Item 161) The method according to item 160, wherein shrinking the malleable shape memory material includes heating the malleable shape memory material. (Item 162) The method according to item 161, wherein the heating includes flowing heated saline solution through the device via a catheter. (Item 163) The heating method according to item 161, which includes applying radio frequency (RF) energy to the device. (Item 164) The method according to any one of items 160 to 163, wherein expanding the malleable shape memory material includes expanding a balloon within the malleable shape memory material. (Item 165) A repositionable device for fixation within a body lumen, wherein the device is A first component comprising a self-expanding superelastic material, A second component, which is coupled to the first component and comprises a malleable shape memory material, Equipped with, The self-expanding superelastic material has a predetermined fully expanded dimension, The second component has a first dimension suitable for deployment through a catheter, The malleable shape-memory material is expandable to a second dimension for fixation within a body lumen. The malleable shape memory material is thermally transitionable up to a third dimension. The malleable shape memory material is mechanically expandable up to a fourth dimension. device. (Item 166) A method for repositionably fixing a device within a body lumen, the method being Inserting a device having first and second components that are interconnected into a body lumen, The first component described above comprises a self-expanding superelastic material, The second component comprises a malleable shape memory material having a first dimension. That thing, The malleable shape memory material is expanded to a second dimension, and the device is fixed inside a body lumen. The malleable shape memory material is thermally shrunk, While the malleable shape memory material is thermally contracted, the device is repositioned within the body lumen. The malleable shape memory material is mechanically re-expanded to a third dimension, and the device is fixed inside the body lumen. Methods that include... (Item 167) The method according to item 166, wherein thermally shrinking the malleable shape memory material includes heating the malleable shape memory material. (Item 168) The method according to item 167, wherein the heating includes flowing heated saline solution through the device via a catheter. (Item 169) The heating method according to item 167, which includes applying radio frequency (RF) energy to the device. (Item 170) The method according to any one of items 166 to 169, wherein mechanically expanding the malleable shape memory material includes expanding a balloon within the malleable shape memory material. (Item 171) A dilator for enlarging an opening through the area of ​​the human body, wherein the dilator is A sheath having a proximal end and a distal end, A dilator positioned at the distal end of the sheath, comprising a tip, an expansion region, and a contraction region. Equipped with, The reduced region is sized to engage securely with the distal end of the sheath. The enlarged region is sized to provide a smooth profile between the sheath and the tip. The distal end of the aforementioned tip is tapered until it becomes almost a point. At least the expanding region and the shrinking region comprise a martensitic shape memory material having an austenite termination temperature (Af) substantially above 37°C, thereby, upon application of heat within the body, the shape memory material returns to smaller heat-set outer dimensions such that the dilator has a substantially smoother, reduced size profile. Dilator. (Item 172) The dilator according to item 171, wherein the tip also includes the martensitic shape memory material. (Item 173) The tip is a dilator according to item 171, comprising a self-expanding superelastic material. (Item 174) A system comprising a dilator described in any one of items 171 to 173 and a device deployed within the opening. (Item 175) A method for forming an enlarged opening through the region of the human body, wherein the method is The guide wire is positioned through the aforementioned region of the human body to form an opening, The dilator is pushed through the opening via the guide wire to form an enlarged opening. Heating the dilator and reducing its size, While the dilator has the reduced size, the dilator is removed through the enlarged opening. Methods that include... (Item 176) The method according to item 175, wherein the heating includes flowing heated saline solution through a catheter through the dilator. (Item 177) The heating method according to item 175, which includes applying radio frequency (RF) energy to the dilator. (Item 178) The method according to any one of items 175 to 178, further comprising deploying the device within the opening and removing the dilator through the device. (Item 179) It is a transatrial gate, A left atrial disk comprising a first self-expanding superelastic material, A right atrial disc comprising a second self-expanding superelastic material, A martensite shape memory material that is heat-set to completely block the passage between the left and right atrial disks, which is expandable to allow passage between the left and right atrial disks, and A transatrial gate equipped with a transcardiac gate. (Item 180) The martensite shape memory material is provided as a mesh, as described in item 179, for the transatrial gate. (Item 181) The martensite shape memory material is a balloon-inflatable transatrial gate as described in item 179 or item 180. (Item 182) The transatrial gate according to any one of items 179 to 181, wherein the martensite shape memory material is configured to be expandable to allow passage between the left and right atrial disks and then closable by the application of heat. (Item 183) A method for carrying out the procedure, wherein the method is The transatrial gate is implanted through an opening in the interatrial septum of the heart, wherein the transatrial gate is A left atrial disk comprising a first self-expanding superelastic material, A right atrial disc comprising a second self-expanding superelastic material, A martensite shape memory material that is heat-set to completely block the passage between the left and right atrial disks, To be equipped with, To expand the martensite shape memory material and enable it to pass between the left and right atrial disks. Methods that include... (Item 184) The material comprises blood, as described in item 183. (Item 185) The material is provided with an apparatus as described in item 183 or item 184. (Item 186) The method according to item 185, comprising performing an additional procedure in the left atrium of the heart using the instrument. (Item 187) The additional procedure described above includes RF ablation, left atrial appendage closure, MitraClip implantation, mitral valve replacement, or mitral valve repair, as described in item 186. (Item 188) The martensitic shape memory material is provided as a mesh, according to the method described in any one of items 183 to 187. (Item 189) The martensitic shape memory material is expanded using a balloon, as described in any one of items 183 to 188. (Item 190) The method according to any one of items 183 to 189, further comprising closing the martensitic shape memory material by applying heat after the expansion. (Item 191) Apparatus, the apparatus, It is a device, A proximal portion configured to be located within the first atrium of the heart, It is configured to be positioned within the second atrium of the heart and comprises a distal portion having a first self-expanding superelastic material, An intermediate portion is positioned between the proximal portion and the distal portion and is configured to be positioned within the atrial septum between the first atrium and the second atrium, wherein the intermediate portion comprises a malleable shape memory material, and A device equipped with, Catheter and, At least one convergent flexible longitudinal element and Equipped with, The first self-expanding superelastic material has a predetermined fully expanded dimension, The aforementioned intermediate portion has a first dimension suitable for deployment through the catheter, The aforementioned intermediate portion is expandable to a second dimension for fixation within the septum. The aforementioned intermediate portion is thermally transitionable up to a third dimension. The aforementioned intermediate portion is mechanically expandable to a fourth dimension. The device is removable by using the at least one converging flexible longitudinal element to pull the device into the catheter. Device. (Item 192) The aforementioned proximal portion is expanded, as described in item 191. (Item 193) The distal portion is expanded, as described in item 191 or item 192. (Item 194) The proximal portion comprises a second self-expanding superelastic material, as described in any one of items 191 to 193. (Item 195) A method, wherein the said method is This involves deploying a device through a catheter, through the atrial septum of the heart. The device described above, The proximal portion located within the first atrium of the heart, Displaced within the second atrium of the heart, a distal portion comprising a first self-expanding superelastic material, An intermediate portion located between the proximal portion and the distal portion, and located within the atrial septum between the first atrium and the second atrium, wherein the intermediate portion comprises a malleable shape memory material, and Equipped with, The first self-expanding superelastic material has a predetermined fully expanded dimension, The aforementioned intermediate portion, when unfolded through the catheter, has a first dimension. That thing, Extending the aforementioned intermediate portion to a second dimension for fixing within the septum, The intermediate portion is thermally transitioned to a third dimension, The aforementioned intermediate portion is mechanically re-expanded to a fourth dimension, The device is removed by using at least one converging flexible longitudinal element to pull the device into the catheter. Methods that include... (Item 196) The aforementioned proximal portion is expanded, as described in item 195. (Item 197) The distal portion is expanded, as described in item 195 or item 196. (Item 198) The method according to any one of items 195 to 197, wherein the proximal portion comprises a second self-expanding superelastic material. (Item 199) The device according to any one of items 111-137 or 165, wherein the first component and the second component are integrally formed from a common frame with respect to each other. (Item 200) The method according to any one of items 155-159, 160-164, or 166-170, wherein the first component and the second component are integrally formed from a common frame with respect to each other. (Item 201) A dilator according to any one of items 171 to 174, wherein the tip, the reduction region, and the expansion region are integrally formed from a common frame with respect to each other. (Item 202) The left atrial disk, the right atrial disk, and the martensite shape memory material are integrally formed from a common frame with respect to each other, as described in any one of items 179 to 182. (Item 203) The method according to any one of items 183 to 190, wherein the left atrial disk, the right atrial disk, and the martensite shape memory material are integrally formed from a common frame with respect to each other. (Item 204) The apparatus according to any one of items 191 to 194, wherein the proximal portion, the distal portion, and the intermediate portion are integrally formed from a common frame with respect to each other. (Item 205) The method according to any one of items 195 to 198, wherein the proximal portion, the distal portion, and the intermediate portion are integrally formed from a common frame with respect to each other. [Brief explanation of the drawing]

[0082] [Figure 1-1] Figures 1A–1E schematically illustrate exemplary devices with internal dimensions that can be reduced and increased in size within a living organism. [Figure 1-2]Figures 1A–1E schematically illustrate exemplary devices with internal dimensions that can be reduced and increased in size within a living organism.

[0083] [Figure 2] Figures 2A–2E schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in size within a living organism.

[0084] [Figure 3] Figures 3A–3D schematically illustrate exemplary devices with multiple internal dimensions that can be reduced and increased in size within a living organism.

[0085] [Figure 4] Figures 4A–4B schematically illustrate exemplary encapsulation materials that may be provided within a device, with internal dimensions that can be reduced and increased in vivo.

[0086] [Figure 5] Figures 5A-5B schematically illustrate exemplary arrangements of components within a device, including their internal dimensions, which can be reduced and increased in size within a living organism.

[0087] [Figure 6] Figure 6 schematically illustrates another exemplary device with internal dimensions that can be reduced and increased in size within a living organism.

[0088] [Figure 7] Figure 7 schematically illustrates another exemplary device with internal dimensions that can be reduced and increased in size within a living organism.

[0089] [Figure 8] Figures 8A–8D schematically illustrate exemplary steps for using the device shown in Figure 7 within the human body.

[0090] [Figure 9] Figures 9A to 9B schematically illustrate an exemplary configuration of the device shown in Figure 7.

[0091] [Figure 10] Figures 10A to 10C schematically illustrate the exemplary use of the tools used to prepare the device shown in Figure 7.

[0092] [Figure 11] Figures 11A to 11B schematically illustrate exemplary modifications of the device shown in Figure 7.

[0093] [Figure 12] Figures 12A–12B schematically illustrate another exemplary modification of the device shown in Figure 7.

[0094] [Figure 13] Figures 13A–13B schematically illustrate another exemplary modification of the device shown in Figure 7.

[0095] [Figure 14-1] Figures 14A–14C schematically illustrate another exemplary device with multiple internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Figure 14-2] Figures 14A–14C schematically illustrate another exemplary device with multiple internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body.

[0096] [Figure 15-1] Figures 15A–15D schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Figure 15-2] Figures 15A–15D schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Figure 15-3] Figures 15A–15D schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body.

[0097] [Figure 16] Figures 16A–16B schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body.

[0098] [Figure 17] Figure 17 illustrates the workflow in an exemplary method for reducing and increasing the internal dimensions of a device within a living organism.

[0099] [Figure 18] Figure 18 illustrates the workflow in an exemplary method for securing a device within a body lumen.

[0100] [Figure 19] Figures 19A–19D schematically illustrate exemplary dilator devices with certain external dimensions that can be reduced and increased in vivo.

[0101] [Figure 20-1] Figures 20A to 20I schematically illustrate the use of the delivery devices shown in Figures 19A to 19D within the human body. [Figure 20-2] Figures 20A to 20I schematically illustrate the use of the delivery devices shown in Figures 19A to 19D within the human body.

[0102] [Figure 21] Figures 21A–21D schematically illustrate exemplary transatrial gates with internal dimensions that can be reduced and increased in vivo.

[0103] [Figure 22-1] Figures 22A-22H schematically illustrate the use of the transatrial gate shown in Figures 21A-21D within the human body. [Figure 22-2] Figures 22A-22H schematically illustrate the use of the transatrial gate shown in Figures 21A-21D within the human body.

[0104] [Figure 23-1]Figures 23A–23E schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its temporary use in the human body. [Figure 23-2] Figures 23A–23E schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its temporary use in the human body. [Figure 23-3] Figures 23A–23E schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its temporary use in the human body. [Figure 23-4] Figures 23A–23E schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its temporary use in the human body.

[0105] [Figure 24-1] Figures 24A–24H are images of devices prepared and used according to the embodiments provided herein. [Figure 24-2] Figures 24A–24H are images of devices prepared and used according to the embodiments provided herein. [Figure 24-3] Figures 24A–24H are images of devices prepared and used according to the embodiments provided herein. [Figure 24-4] Figures 24A–24H are images of devices prepared and used according to the embodiments provided herein.

[0106] [Figure 25] Figures 25A to 25D schematically illustrate exemplary modifications of the device shown in Figure 7.

[0107] [Figure 26-1] Figures 26A–26H schematically illustrate another exemplary modification of the device shown in Figure 7. [Figure 26-2] Figures 26A–26H schematically illustrate another exemplary modification of the device shown in Figure 7. [Figure 26-3]Figures 26A–26H schematically illustrate another exemplary modification of the device shown in Figure 7. [Figure 26-4] Figures 26A–26H schematically illustrate another exemplary modification of the device shown in Figure 7.

[0108] [Figure 27-1] Figures 27A–27K schematically illustrate another exemplary modification of the device shown in Figure 7. [Figure 27-2] Figures 27A–27K schematically illustrate another exemplary modification of the device shown in Figure 7. [Figure 27-3] Figures 27A–27K schematically illustrate another exemplary modification of the device shown in Figure 7.

[0109] [Figure 28] Figures 28A–28D schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in size within a living organism.

[0110] [Figure 29] Figures 29A to 29D schematically illustrate examples of the use of the devices shown in Figures 28A to 28B within the human body.

[0111] [Figure 30] Figures 30A to 30C schematically illustrate examples of the use of the device shown in Figure 28C within the human body.

[0112] [Figure 31-1] Figures 31A–31E schematically illustrate exemplary devices with configurations that can be reversibly modified in vivo. [Figure 31-2] Figures 31A–31E schematically illustrate exemplary devices with configurations that can be reversibly modified in vivo. [Figure 31-3] Figures 31A–31E schematically illustrate exemplary devices with configurations that can be reversibly modified in vivo.

[0113] [Figure 32-1]Figures 32A–32G schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Figure 32-2] Figures 32A–32G schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Figure 32-3] Figures 32A–32G schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Figure 32-4] Figures 32A–32G schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and examples of its use in the human body. [Modes for carrying out the invention]

[0114] Detailed explanation This disclosure provides a device having dimensions that can be reduced and increased in vivo, as well as methods for fabricating and using the same.

[0115] For example, the device may be permanently or temporarily implantable in the human body and may contain one or more components that can be adjusted in size, becoming larger or smaller after implantation. The need for such an adjustable device may arise, for example, in the treatment of pulmonary hypertension (PAH) or heart failure (HF). In PAH, placing a shunt within the interatrial septum allows some blood to flow from the right atrium to the left atrium through an orifice, thereby alleviating excessive blood pressure in the right atrium. In HF, placing a shunt within the interatrial septum allows some blood to flow from the left atrium to the right atrium through an orifice, thereby alleviating excessive blood pressure in the left atrium. In both PAH and HF, interatrial shunts have been shown to effectively reduce symptoms and increase exercise tolerance. Interatrial shunts may also reduce the need for hospitalization and, furthermore, improve life expectancy.

[0116] However, if the orifice of an interatrial shunt is too small, only a very small amount of blood can be transported, and the shunt will be relatively ineffective and provide little or no clinical benefit. In contrast, shunting too much blood ("hypershunt") through an orifice that is too large can lead to serious or even fatal complications over time. For example, in PAH patients, hypershunt can result in polycythemia with cyanosis, increased blood viscosity, peripheral organ ischemia, and potentially systemic oxygen desaturation and its sequelae, including death. In HF patients, hypershunt can result in pulmonary hypertension, right ventricular failure, and potentially death.

[0117] Currently, there is no known method for predicting a given patient's response to a specific shunt orifice size. As is known, shunt orifices can be enlarged in vivo by inflating a suitably designed shunt, for example, by expanding an inflatable balloon catheter or other similar mechanical dilation means within the shunt; however, this assumes that the shunt is made from a malleable material and remains expanded due to plastic deformation or some other physical property, thereby ensuring that when the balloon or other dilation means is removed, the amount of elastic rebound or bounce will be low enough to achieve the desired increment in the orifice size. One drawback of this approach is that the orifice size can only be increased. If the shunt starts too large, or becomes too large by balloon dilation, but the patient requires a smaller shunt, there is no way to return to a smaller size orifice other than providing another smaller shunt or placing a smaller shunt within the lumen of the original shunt. This technique is known as "shunt-in-shunt." Therefore, finding a suitable shunt orifice size for a given patient is a trial-and-error process in which the shunt orifice size is selected according to the patient's response, which is observed over a time period that can be as short as a few minutes or as long as several months, and the shunt orifice size can be increased (e.g., by balloon expansion) or decreased (by providing a new, smaller shunt) depending on the patient's response. Thus, opportunities to increase or decrease the shunt size are very limited and cannot be repeated. Furthermore, the range to which an inflatable balloon catheter can expand the shunt orifice may be limited by the maximum size of the balloon. Therefore, what is needed are means and other implantable devices for repeatedly and non-traumatically adjusting the shunt orifice size in vivo, and in both directions, either larger or smaller.

[0118] Provided herein are devices having cross-sectional areas that can be readily reduced and expanded in vivo as required clinically, in any order. In particular, some embodiments of the devices include self-expanding superelastic (austenite phase) materials and malleable shape memory (martensite phase) materials. When the devices are implanted in the human body, for example by transporting the device in a compressed state within a sheath to the desired location and then removing the sheath, the self-expanding superelastic materials can automatically expand to their desired size, while the malleable shape memory materials may initially remain in a reduced size state. The cross-sectional area of ​​the malleable shape memory material may then be expanded and contracted in vivo as desired to properly secure the device within the patient, while allowing it to be repositioned, for example, to obtain a cross-sectional area suitable for treating a patient or to improve the effectiveness of treatment by providing a suitable fluid flow rate through it. The widths of the various devices may be provided using components, each including self-expanding superelastic and malleable shape memory materials as illustrated herein.

[0119] For example, Figures 1A to 1E schematically illustrate exemplary devices with internal dimensions that can be reduced and increased in size within a living organism. The device 100 illustrated in Figures 1A to 1E includes a first component 110 and a second component 120 coupled to the first component 110, for example, by fluidic coupling. The first component 110 may include a self-expanding hyperelastic material, and the second component 120 may include a malleable shape memory material. The malleable shape memory material of the second component 120 may have a first cross-sectional area that allows a first rate of fluid to flow through the second component, may be expandable to a second cross-sectional area that allows a second rate of fluid to flow through the second component, and may be contractible to a third cross-sectional area that allows a third rate of fluid to flow through the second component. Note that the overall rate of fluid flowing through device 100 may also depend on the cross-sectional area of ​​the first component 110.

[0120] For example, Figure 1A schematically illustrates a device 100 in a compressed or crimped state, loaded into a sheath 130 for percutaneous implantation into the human body. In the crimped state, both the first component 110 and the second component 120 may have dimension D1 (corresponding to the first cross-sectional area). Once the device 100 is delivered to the desired location, the sheath 130 may be retracted to percutaneously implant the device. As shown in Figure 1B, following the removal of the sheath 130, the self-expanding superelastic material of the first component 110 may automatically expand to its heat-set superelastic configuration with dimension Ds in this embodiment, while the malleable shape-memory material of the second component 120 may remain in a crimped state (e.g., first dimension D1, corresponding to the first cross-sectional area) until further adjustment is made. The second component 120 may be expanded by any preferred amount, for example, to dimension D2 (corresponding to the second cross-sectional area), as shown in Figure 1C. The second component 120 may also be reduced by any preferred amount, for example, as shown in Figures 1D and 1E, by first using shape memory properties to shrink the component 120 to its annealed configuration dimension D0, and then expanding it to dimension D3 (corresponding to the third cross-sectional area), (for example, by balloon inflation). Based on a specific dimension (and cross-sectional area) in which the second component 120 is adjusted by expansion or contraction, different fluid flow rates can be enabled through the component, and thus provide an adjustable orifice for controlling the flow of fluid within the location of the human body in which the device 100 is deployed.

[0121] In some embodiments, reducing the dimensions of a shape memory material-based component according to this specification always returns the component to its heat-set (annealed) dimension D0, which is determined during manufacturing by heat-setting in a jig. Once the dimension is thus reduced, it may then be expanded to an intermediate dimension, for example, by balloon inflation. In addition, it should be noted that in some embodiments, D0 and D1 may be substantially identical to each other, in other embodiments D0 may be smaller than D1, and in yet another embodiment D0 may be larger than D1. Figures 1A-1E illustrate only four exemplary dimensions D0, D1, D2, and D3 of the second component 120, but it should be understood that any suitable dimension exceeding the minimum value set by the annealed configuration D0 may be obtained by balloon inflation as desired. For example, D2 may be smaller than D3. Alternatively, D2 may be larger than D3, and D3 may be achieved by reducing the second component 120 to its heat-set dimension D0, as shown in Figure 1D, and then expanding the second component 120 to dimension D3, as shown in Figure 1E. In some embodiments, the second component may be heated using a high-temperature balloon, which is then deflated to the desired dimension, followed by cooling of the second component. As heating creates a crystalline phase change, the dimensions of the second component are never plastically deformed by balloon inflation, and thus the shunt can be repeatedly cycled from one dimension to another, larger or smaller, through any number of cycles requested by the patient, thereby optimizing the shunt size.

[0122] As used herein, “internal dimensions” refer to the lateral dimensions between the inner walls of the device components, for example, along line A to A shown in Figures 1A to 1E. As used herein, “external dimensions” refer to the lateral dimensions between the outer walls of the device components, for example, along line AA shown in Figures 1A to 1E. As used herein, “cross-sectional area” refers to the area of ​​the cross-sectional plane within the walls of the device in a plane extending through that dimension, for example, a plane parallel to line AA shown in Figures 1A to 1E and intersecting through the second component 120. Expansion or contraction of dimensions may refer to the distance between the walls of the device components at a specific location within that component, for example, along line AA shown in Figures 1A to 1E. Expansion or contraction of cross-sectional area may refer to the area within the walls of the device in a plane extending through the corresponding dimensions of the device components at a specific location within that component, for example, along line AA shown in Figures 1A to 1E. This device may have any suitable cross-sectional shape, and may include, but is not limited to, a circular or uniform cross-section.

[0123] In the non-limiting embodiments shown in Figures 1B and 1D, a force may be applied to the interface between the crimped second component 120 and the expanded first component 110, preventing the first component 110 from expanding completely. It should also be understood that such an interface may instead apply a force that causes the second component 120 to expand partially. As will be described in more detail below, a particular manner in which the first component 110 and the second component 120 are joined to each other may be selected to control the force(s) applied to such components, and therefore the shape and dimensions of such components.

[0124] In some embodiments, the self-expanding superelastic material of the first component 110 and the malleable shape memory material of the second component 120 may comprise materials that are different from each other, or materials that are identical to each other but have different phases. For example, the first component 110 and the second component 120 may independently comprise one or more materials selected from the group consisting of nickel titanium (NiTi), also known as nitinol, other shape memory alloys, self-expanding materials, superelastic materials, polymers, and equivalents. For example, the first component 110 may comprise a nitinol alloy having an austenite termination temperature (Af) well below body temperature, and the material is in the austenite superelastic phase while in the human body. In one non-limiting embodiment, the self-expanding superelastic material of the first component 110 comprises nitinol having an Af of less than 37°C. For example, the Af of the nitinol in the self-expanding superelastic material may be between 5 and 20°C. The first component 110 and the second component 120 may optionally be formed integrally from a common frame with respect to each other. For example, the first component 110 and the second component 120 may first be cut and processed as single units from the same tubing, sheets, or other suitable structural frame with respect to each other. The portion of the common frame may be heat-treated differently from each other to define the first component 110 and the second component 120, for example, similar to those described with reference to Figures 10A-10C.

[0125] The second component 120 may include a nitinol alloy having an austenite phase transition temperature Af slightly above body temperature, unless heated to or above its Af by, for example, injecting heated or high-temperature saline (or other fluid) into a fluid flowing in or through the second component 120, or by applying heat through electrical energy using an RF energy source, and until then the material remains in its martensite shape memory phase while it is in the body. In one non-limiting embodiment, the malleable shape memory material of the second component 120 includes nitinol having an austenite termination temperature (Af) above 37°C. For example, the Af of the nitinol in the malleable shape memory material of the second component 120 may be 45-60°C, for example, from 50-55°C. In some embodiments, heated or high-temperature saline (or other fluid) may be injected in close proximity to the second component 120 to heat its component to its Af or above, using a side-hole catheter positioned through the device 100. In other embodiments, a pair of RF electrodes may be in contact with the device 100, for example, via a catheter, and operated at a voltage and frequency sufficient to heat the component 120 to its Af or above. In yet another embodiment, any other suitable means for locally applying heat to the device 100 may be used, such as a laser, magnetic inductance, electrical resistance, or equivalent. Heating the device 100 using electrical resistance may include, for example, bringing the device into contact with a pair of electrodes via a catheter and passing an electric current through the device, causing the device to heat up. Heating the device 100 using a laser may include irradiating the device with light from a laser, which can be introduced by a catheter. Heating the device 100 using magnetic inductance may include passing an alternating magnetic field through the device, which induces eddy currents inside the device, causing the device to heat up.It should be noted that in blood vessels, particularly those with high blood flow rates (e.g., 2-5 L / min), such as the aorta or internal iliac artery, it may be useful to heat device 100 using a direct heating method that uses RF energy, laser, magnetic inductance, or electrical resistance instead of saline solution that can be flowed by the high blood flow rate, before the device is sufficiently heated.

[0126] Alternatively, the device 100 may include a single nitinol alloy (common frame) such that the first component 110 and the second component 120 are integrally formed with each other, with the region corresponding to the first component 110 being heat-treated to produce a lower Af and the region corresponding to the second component 120 being heat-treated to produce a higher Af. The malleable shape memory material of the second component 120 may be expandable and contractible using any preferred technique. For example, the malleable shape memory material of the second component 120 may be mechanically expanded, for example, by balloon expansion, as known in the art. In addition, or alternatively, the malleable shape memory material of the second component 120 may be thermally contracted, for example, by using saline solution at or above the Af of the material, in the manner described above, or otherwise heated, for example, by using RF energy or a laser, magnetic inductance, electrical resistance, or equivalent.

[0127] Optionally, the first component 110 may be configured to engage with a lumen in the body in a manner that is illustrated with reference to, for example, Figures 14A-14C, 15A-15D, or 16A-16B. For example, the lumen may include a blood vessel, and the first component may be configured to engage with the blood vessel.

[0128] It should be understood that this device may include any number of suitable components, including a self-expanding superelastic material, and any number of suitable components, including a malleable shape memory material. For example, Figures 2A-2E schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo. The device 200 illustrated in Figures 2A-2E includes a first component 210, a second component 220, and a third component 211 coupled to the first component 210 and the second component 220, for example, by fluid coupling. The first component 210 may include a first self-expanding superelastic material, the second component 220 may include a malleable shape memory material, and the third component 211 may include a second self-expanding superelastic material. The malleable shape memory material of the second component 220 may have a first cross-sectional area that allows a first rate of fluid to flow through the second component, may be expandable to a second cross-sectional area that allows a second rate of fluid to flow through the second component, and may be contractible to a third cross-sectional area that allows a third rate of fluid to flow through the second component.

[0129] For example, Figure 2A schematically illustrates a device 200 in a crimped state, loaded into a sheath 230 for percutaneous implantation into the human body. In the crimped state, the first component 210, the second component 220, and the third component 211 may have a dimension D1 (corresponding to the first cross-sectional area). Once the device 200 is delivered to the desired location, the sheath 230 may be retracted to percutaneously implant the device. As shown in Figure 2B, following the removal of the sheath 230, the self-expanding superelastic material of the first component 210 and the third component 211 may automatically expand to the heat-set dimension Ds, while the malleable shape-memory material of the second component 220 may remain in a crimped state (e.g., the first cross-sectional area) until further adjustment is required. The second component 220 may be expanded by any preferred amount, for example, to dimension D2 (corresponding to the second cross-sectional area), as shown in Figure 2C. The second component 220 may be expanded by any preferred amount in the same manner as described above with respect to Figure 1, for example, as shown in Figure 2E, by first heating the shape memory component 220 above its Af temperature, returning it to its annealed configuration D0, as shown in Figure 2D, and then shrinking it to dimension D3 (corresponding to the third cross-sectional area) by expanding it (for example, by balloon inflation). Based on a specific dimension (and cross-sectional area) in which the second component 220 is adjusted by expansion or contraction, different fluid flow rates may be enabled through the component, and thus provide an adjustable orifice for controlling the flow of fluid in the location of the human body in which the device 200 is deployed. It should be noted that the overall rate of fluid flowing through device 200 may also depend on the cross-sectional areas of the first component 210 and the second component 211.

[0130] Figures 2A-2E illustrate only three exemplary dimensions D1, D2, and D3 of the second component 220, but it should be understood that any preferred dimensions may be obtained by expanding or contracting the second component as desired. Note that in some embodiments, D0 and D1 may be substantially identical to each other, in other embodiments D0 may be smaller than D1, and in yet another embodiment D0 may be larger than D1. Furthermore, it should be understood that the shape memory component may be formed and heat-set into other geometric shapes in addition to the circular cylindrical shape illustrated herein, and its shape may be modified in other ways in addition to radial expansion as illustrated herein, and the shape memory component may be returned to its original heat-set geometric shape by heating it above its Af temperature. In addition, it should be understood that, with respect to each of the embodiments described herein, the component does not necessarily have to have a circular cross-section, but may have any preferred cross-sectional shape.

[0131] In the non-limiting embodiments shown in Figures 2B and 2D, the crimped state of the second component 220 and the respective interfaces between the expanded first component 210 and the expanded third component 211 may have forces applied to prevent the first component 210 and the third component 211 from expanding completely. It should also be understood that such interfaces (one or more) may instead have forces applied to partially expand the second component 220. As will be described in more detail below, the particular manner in which the first component 210, the second component 220, and the third component 211 are joined to each other may be selected to control the forces (one or more) applied to such components, and therefore the shape and dimensions of such components. The first component 210 and the third component 211 may, but do not necessarily, be identical in dimensions, shape, and size to each other.

[0132] In some embodiments, the first self-expanding superelastic material of the first component 210, the malleable shape memory material of the second component 220, and the second self-expanding superelastic material of the third component 211 may comprise materials that are different from each other, or materials that are identical to each other but have different phases. For example, the first component 210, the second component 220, and the third component 211 may independently comprise one or more materials selected from the group consisting of nickel titanium (NiTi), also known as nitinol, other shape memory alloys, self-expanding materials, superelastic materials, polymers, and equivalents. In one non-limiting embodiment, the first component 210 and the third component 211 may each comprise a nitinol alloy having Af well below body temperature, and the material is in the austenite superelastic phase while in the human body, in a manner described with reference to Figures 1A-1E. The second component 220 may include a nitinol alloy having an austenite phase transition temperature Af slightly above body temperature, so that the material remains in its martensite shape memory phase while it is in the body, unless heated to its Af by, for example, injection of heated or hot saline solution into a fluid flowing within or through the second component 220, or by application of RF energy, or by the use of a laser, magnetic inductance, electrical resistance, or equivalent, and until then. Alternatively, the device 200 may include a single nitinol alloy, heat-treated to produce a lower Af in the regions corresponding to the first component 210 and the third component 211, and a higher Af in the region corresponding to the second component 220. The malleable shape memory material of the second component 220 may be expandable and contractible using any preferred technique, for example, as described with reference to Figures 1A to 1E. The first component 210, the second component 220, and the third component 211 may optionally be formed integrally from a common frame with reference to Figures 1A to 1E.

[0133] In a configuration as described in more detail with reference to Figures 7-12B and 15A-15D, a first component 210 may provide an inlet, a second component 220 may provide a neck portion, and a third component 211 may provide an outlet, for example, fluidically coupled, which is coupled to the inlet via the neck portion. As used herein, “inlet” means a component with an inflow of blood flow, and “outlet” means a component with a retreat (outflow) of blood flow. Specific components that can be used to provide the inflow and retreat (outflow) of blood flow may be selected based on the condition being treated. For example, in HF, the inlet may be on the left atrium (LA) side, and blood flow from LA to the right atrium (RA) and LA decompression are desirable. In contrast, in PAH, the interatrial pressure gradient is reversed, causing flow from R to L and RA decompression, and the inlet is on the RA side. The cross-sectional area of ​​the neck portion may be smaller than the cross-sectional area of ​​at least one of the inlet and outlet, for example, as will be explained in more detail with reference to Figures 7-12B. Alternatively, the cross-sectional area of ​​the neck portion may be larger than the cross-sectional area of ​​at least one of the individual inlet and outlet, for example, as will be explained in more detail with reference to Figures 15A-15B. The third component 211 may be configured to engage with an opening in the human body, for example, in a manner that is explained with reference to Figures 7-12B. In addition, or alternatively, the first component 210 may be configured to engage with a lumen in the body, for example, in a manner that is explained with reference to Figures 15A-15D. Optionally, the third component 211 may be configured to engage with a lumen in the body, for example, in a manner that is explained with reference to Figures 15A-15D. For example, the lumen may include a blood vessel, and the first and third components may be configured to engage with a blood vessel. If present, the neck portion may optionally be configured to be positioned adjacent to the opening of a blood vessel, for example, in a manner as described with reference to Figures 15A to 15D.

[0134] Figures 3A–3D schematically illustrate exemplary devices with multiple internal dimensions that can be reduced and increased in vivo. The device 300 illustrated in Figures 3A–3D includes a first component 310, a second component 320, and a third component 321 coupled to the first component 310 and the second component 320, for example, by fluid coupling. The first component 310 may include a self-expanding hyperelastic material, the second component 320 may include a first malleable shape memory material, and the third component 321 may include a second malleable shape memory material. The malleable shape memory material of the second component 320 and the third component 321 may have a first cross-sectional area that allows a first rate of fluid to flow through the second component, may be expandable to a second cross-sectional area that allows a second rate of fluid to flow through the second component, and may be contractible to a third cross-sectional area that allows a third rate of fluid to flow through the second component. Note that the cross-sectional areas, sizes, and shapes of the second component 320 and the third component 321 may be identical to each other, but are not necessarily required. Note that the overall rate of fluid flowing through the device 200 may also depend on the cross-sectional areas of the first component 210 and the second component 211. As an example, in embodiments where the cross-sectional area of ​​the second component 320 is smaller than that of the third component 321, or where the cross-sectional area of ​​the second component 320 is larger than that of the third component 321, the smaller cross-sectional area may define the rate at which fluid flows through the device 300.

[0135] In addition to defining the rate of fluid flowing through device 300, embodiments such as those described with reference to Figures 3A-3D may allow for controllable adjustment of the contact for securing or fixing the device to the wall of body space by balloon expansion of the contacting components 320, 321, for example, in the manner described with reference to Figures 14A-14C, while allowing these contacting components to be deflated after deployment so that the device can be repositioned. In addition, or alternatively, embodiments such as those described with reference to Figures 3A-3D may provide a relatively safer implantation method compared to, for example, expanding all of the first, second, and third components 310, 320, and 321 together. For example, in the implementation described with reference to Figures 14A-14C, expanding all of the first, second, and third components 310, 320, and 321 together may result in the occlusion of branching arteries. Allowing selective expansion of specific compartments in a more gradual manner may be safer.

[0136] Figure 3A schematically illustrates the device 300 in a crimped state, loaded into a sheath 330 for percutaneous implantation into the human body. In the crimped state, the first component 310, the second component 320, and the third component 321 may have a dimension D1 (corresponding to the first cross-sectional area). Once the device 300 is delivered to the desired location, the sheath 330 may be retracted to percutaneously implant the device. As shown in Figure 3B, following the removal of the sheath 330, the self-expanding superelastic material of the first component 310 may automatically expand, while the first malleable shape memory material of the second component 320 and the second malleable shape memory material of the third component 321 may remain in a crimped state (e.g., the first cross-sectional area) until they are further adjusted. The second component 320 and the third component 321 may be independently enlarged by any preferred amount, for example, to their respective dimensions D2 (corresponding to the second cross-sectional area) and D3, as shown in Figure 3C. The second component 320 and the third component 321 may be independently reduced to their respective heat-set dimensions and then enlarged by any preferred amount, for example, to their respective dimensions D4 (corresponding to the third cross-sectional area) and D5, as shown in Figure 3D.

[0137] In contrast, the second component 320 and the third component 321 are independently adjusted by expansion or contraction, and based on specific dimensions (and cross-sectional area), different fluid flow rates are enabled through such components, and thus an adjustable orifice for controlling the flow of fluid within the location of the human body in which the device 300 is deployed can be provided. Figures 3A-3D illustrate exemplary dimensions D1, D2, D3, D4, and D5 in which the second component 320 and the third component 321 can be independently set, but it should be understood that any preferred dimensions (one or more) may be obtained as desired by independently expanding or contracting the second and third components. For example, the second component 320 and the third component 321 may have their respective heat-set dimensions D0, which may be the same as or different from each other, or they may be crimped to a dimension D1 that is smaller than D0. The second component 320 and the third component 321 may each be expanded to any preferred size(s) a number of preferred times, reset to D0, and then re-expanded to any preferred size(s).

[0138] In the non-limiting embodiments shown in Figures 3B and 3D, the crimped state of the second component 320 and the respective interfaces between the third component 321 and the expanded first component 310 may apply forces that prevent the first component 310 from expanding completely. It should also be understood that such interfaces may apply forces that, instead, partially expand the second component 320 or the third component 321. As will be described in more detail below, the particular manner in which the first component 310, the second component 320, and the third component 321 are joined to each other may be selected to control the force(s) applied to such components, and therefore the shape and dimensions of such components.

[0139] In some embodiments, the self-expanding superelastic material of the first component 310, the first malleable shape memory material of the second component 320, and the second malleable shape memory material of the third component 321 may comprise materials that are different from each other, or materials that are identical to each other but have different phases. For example, the first component 310, the second component 320, and the third component 321 may independently comprise one or more materials selected from the group consisting of nickel titanium (NiTi), also known as nitinol, other shape memory alloys, self-expanding materials, superelastic materials, polymers, and equivalents. In one non-limiting embodiment, the first component 310 may comprise a nitinol alloy having Af well below body temperature, the material being in the austenite superelastic phase while in the human body, in a manner described with reference to Figures 1A-1E. The second component 320 and the third component 321 may each contain a nitinol alloy having an austenite phase transition temperature Af slightly above body temperature, so that the material remains in its martensite shape memory phase while in the body, unless heated to its Af by, for example, injection of heated or high-temperature saline into the fluid flowing in or through the second component 320 or the third component 321, or by application of RF energy, or by the use of a laser, magnetic inductance, electrical resistance, or equivalent, and until then. Alternatively, the device 300 may contain a single nitinol alloy that is heat-treated to produce a lower Af in the region corresponding to the first component 310, and heat-treated to produce a higher Af in the regions corresponding to the second component 320 and the third component 321, respectively. The second component 320 and the third component 321 may, but do not necessarily, be the same material or have the same Af as each other.The malleable shape memory materials of the second component 320 and the third component 321 may be independently expandable relative to each other using any preferred technique, for example, as described with reference to Figures 1A-1E, and may be reset to their respective heat-set dimensions and then independently re-expanded to their respective dimensions. The first component 310, the second component 320, and the third component 321 may optionally be integrally formed from a common frame with respect to each other in a manner as described with reference to Figures 1A-1E.

[0140] In a manner more accurately described with reference to Figures 14A-14C, the cross-sectional areas of the second component 320 and the third component 321 may be expanded independently of each other to secure the device within the lumen while allowing for repositioning. In an embodiment more accurately described with reference to Figures 14A-14C, the second component 320 may be configured as an inlet, and the third component 321 may be configured as an outlet fluidly coupled to the inlet via the first component 310. The inlet 320 may be configured to engage with a blood vessel in the human body, as described with reference to Figures 14A-14C, and the outlet 321 may be configured to extend into the mouth of the blood vessel. A fourth component may be configured to be fluidly coupled to the first component 310 and extend into another mouth of the blood vessel, for example, as described with reference to Figures 14A-14C. In some embodiments, the first component 310 may be configured to provide a fluid pathway for blood flow, for example, to deliver blood flow over a weak section of an aneurysm, such as an aortic aneurysm. To effectively protect the aneurysm from the stress of aortic pressure, the inlet 320, outlet 321, and the fourth component may be expanded to form a sufficiently tight seal with their respective vessel(s).

[0141] In the devices exemplified by devices 100, 200, 300, etc., as described with reference to Figures 1A-1E, 2A-2E, and 3A-3D, the first, second, and (if present) third components are joined to one another using any preferred joining method(s), for example, fluidically. For example, any malleable shape memory material (in components 120, 220, 320, or 321, etc.) may be joined to any self-expanding hyperelastic material (in components 110, 210, 211, or 310, etc.) by welding, at the discretion of the parties involved. In addition, or alternatively, any malleable shape memory material (in components 120, 220, 320, or 321, etc.) may be joined to any self-expanding hyperelastic material (in components 110, 210, 211, or 310, etc.) using a coating material that can optionally and independently cover at least one portion of the components and join such components to one another. In addition, or alternatively, any shape memory material and any self-expanding hyperelastic material may be integrally formed from a common frame with respect to one another.

[0142] For example, Figures 4A–4B schematically illustrate exemplary coverings that may be provided within a device, having internal dimensions that can be reduced and increased in vivo. In the exemplary device 400 shown in Figure 4A, which may include any preferred number of components (only two are shown for convenience), the covering 440 covers a portion of each of the first component 410 and the second component 420, which may be configured as described with reference to Figures 1A–1E, 2A–2E, or 3A–3D. The covering 440 may fluidly bond a malleable shape memory material (e.g., component 420) to a self-expanding hyperelastic material (e.g., component 410). Optionally, the covering 440 indirectly and elastically bonds the malleable shape memory material to the self-expanding hyperelastic material. In the exemplary device 401 illustrated in Figure 4B, which may include any preferred number of components (only two components are illustrated for convenience), the encasing material 441 covers the entirety of each of the first component 410 and the second component 420, which components may be configured as described with reference to Figures 1A-1E, 2A-2E, or 3A-3D. The encasing material 440 or 441 may fluidly bond a malleable shape memory material (e.g., of component 420) to a self-expanding hyperelastic material (e.g., of component 410). In other embodiments (not specifically illustrated), it should be understood that the encasing material may completely cover one or more components, or only partially cover one or more other components. The encasing material may indirectly bond one or more components to one or more components. A combination of encasing and mechanical engagement, e.g., welding or mechanical interference, may be used, both directly and indirectly, to bond the components to one another.

[0143] The coating materials 440 and 441 may contain any suitable biocompatible material, such as polymers or natural materials. Examples of polymers suitable for use as coating materials include stretched polytetrafluoroethylene (ePTFE), silicone, polycarbonate urethane, DACRON (polyethylene terephthalate), ultra-high molecular weight polyethylene (UHMWPE), and polyurethane. Examples of natural materials suitable for use as coating materials include, for example, human tissue such as pericardial tissue from horse, cattle, or pig sources, or human placenta or other human tissue. The biocompatible material is preferably smooth to inhibit thrombus formation and may optionally be impregnated with carbon to promote tissue internal growth. Alternatively, the biocompatible material may form a mesh-like structure to promote tissue internal growth and endothelialization. The device may be encapsulated in a biocompatible material in a manner similar to that described in U.S. Patent Publication No. 2019 / 0110911 by Nae et al., entitled "Systems and Methods for Making Encapsulated Hourglass Shaped Stents" (the full contents of which are incorporated herein by reference). For example, one inner surface of the device may be covered with a first graft layer, and the outer surface of the device may be covered with a second graft layer. The graft layers may be bonded together to form a monolithic layer of biocompatible material, or, for example, sintered together to form a firm, smooth, and substantially durable coating covering the inner and outer surfaces of the device. The coating may then be removed from selected portions of the device, as desired, for example, by laser cutting or mechanical cutting.

[0144] In one embodiment, the device is encapsulated in ePTFE. Those skilled in the art will understand that the ePTFE material has a characteristic microstructure consisting of nodules and small fibers, where the orientation of the small fibers is substantially parallel to the axis of longitudinal expansion. Stretched polytetrafluoroethylene material can be produced by ram extruding a compressed mass of particulate polytetrafluoroethylene and an extrusion lubricant through an extrusion die to form a sheet or tubular extruded product. The extruded product is then heated to the crystalline melting point of polytetrafluoroethylene, i.e., 327°C or above, for a sufficient time period to expand longitudinally, form a nodule-small fiber microstructure, and sinter the ePTFE material. Heating may occur in a vacuum chamber to prevent or inhibit oxidation of the device. Alternatively, heating may occur in a nitrogen-rich environment. A furnace may be used to heat the encapsulated device. Alternatively, or in addition, a mandrel on which the encapsulated device rests may be used to heat the encapsulated device.

[0145] In addition to or as an alternative to any other method of joining the components of this device together, one or more of the components may be inserted, whole or in part, into one or more of the other components. For example, Figures 5A–5B schematically illustrate exemplary arrangements of components within the device, with internal dimensions that may be reduced and increased in vivo. In the exemplary device 500 illustrated in Figure 5A, which may include any preferred number of components (only two are illustrated for convenience), the second component 520 is located at least partially inside the first component 510, and that component may be configured similarly to those described with reference to Figures 1A–1E, 2A–2E, or 3A–3D. An overlapping region 550 between the first component 510 and the second component 520, where the region may optionally extend over the entire length of one or both of the first component 510 and the second component 520, can be used to join a malleable shape memory material (e.g., component 520) to a self-expanding hyperelastic material (e.g., component 510). For example, the outer surface of the second component 520 may engage with (e.g., mechanically interfere with) the inner surface of the first component 510 in a manner that prevents lateral movement of the two components relative to each other. In addition, the dimensions of the first component 510 may constrain the expansion of the second component 520 so as not to exceed its dimensions within the overlapping region 550, for example, by applying a force to prevent the second component 520 from expanding completely. Thus, even if the second component 520 is expanded (e.g., mechanically), the dimensions of the first component 510 may prevent the second component from expanding completely to a larger dimension.

[0146] In the exemplary device 501 shown in Figure 5B, which may include any preferred number of components (only two are shown for convenience), the first component 511 is located at least partially inside the second component 521, and the component may be configured as described with reference to Figures 1A-1E, 2A-2E, or 3A-3D. The overlapping region 551 between the first component 511 and the second component 521, whose region may optionally extend over the entire length of one or both of the first component 511 and the second component 521, may be joined to a malleable shape memory material (e.g., component 521) to a self-expanding hyperelastic material (e.g., component 511). For example, the inner surface of the second component 521 may engage with (e.g., mechanically interfere with) the outer surface of the first component 511 in such a manner that it prevents lateral movement of the two components relative to each other. In addition, the dimensions of the second component 521 can be constrained so that the expansion of the first component 511 does not exceed its dimensions within the overlapping region 551, for example, by applying a force to prevent the first component 511 from expanding completely. Thus, even if the first component 511 expands (e.g., self-expands), the dimensions of the second component 521 can prevent the first component from expanding completely to a larger dimension.

[0147] For example, mechanical interference between components, as illustrated with reference to Figures 5A-5B, can prevent rebound of shape memory components. For example, a known problem with martensitic nitinol stents is rebound, in which approximately 10-15% diameter contraction can make adhesion to the vessel wall difficult. Mechanical interference between device components, such as concentric connections illustrated in Figures 5A-5B, can reduce or prevent such rebound. For example, in the configuration illustrated with reference to Figure 5B, the first component 511 can physically prevent the second component 521 from rebounding. In some configurations, the hoop strengths of the first and second components are approximately balanced with respect to each other, and optionally, the shape memory martensite component may be slightly stronger to reduce or minimize rebound.

[0148] It should be understood that devices such as those described with reference to Figures 1A-1E, 2A-2E, and 3A-3D, and their options such as those described with reference to Figures 4A-4B and 5A-5B, may have any preferred configuration. For example, Figure 6 schematically illustrates another exemplary device 600, which has internal dimensions and can be reduced and increased in vivo. Device 600 comprises a first component 610 (also designated "A"), a second component 620 (also designated "B"), and a third component 611 (also designated "C"). Device 600 may optionally include a tube of material that is laser-cut and defines a plurality of sinusoidal rings connected by extending longitudinally a plurality of struts and connecting members, for example, struts (struts are not specifically shown). The sinusoidal rings illustrated in Figure 6 may be laser-cut to form a single-piece component of a one-piece structure, and different regions of the component may be heat-treated differently from each other in a manner as described elsewhere herein to produce components having different Af. Alternatively, the sinusoidal rings of the first component 610, the second component 620, and the third component 611 may be separately defined and subsequently joined together to form components of different materials with suitable Af, forming device 600. Device 600 may also be electropolished to reduce thrombus formation.

[0149] Optionally, the Af of the first component 610 and the Af of the third component 611 may each exceed the Af of the second component 620. For example, the first component 610 may correspond to the first component 210 as described with reference to Figures 2A-2E and may include a first self-expanding superelastic material; the second component 620 may correspond to the second component 220 and may include a malleable shape memory material; and the third component 611 may correspond to the third component 211 and may include a second self-expanding superelastic material. Alternatively, the Af of the first component 610 and the Af of the third component 611 may be less than the Af of the second component 620. For example, the first component 610 may correspond to the first component 310 as described with reference to Figures 3A to 3D, and may include a self-expanding superelastic material; the second component 620 may correspond to the second component 320, and may include a first malleable shape memory material; and the third component 611 may correspond to the third component 321, and may include a second malleable shape memory material. Optionally, the Af of the first component 610 and the Af of the third component 611 may be the same as each other.

[0150] It should be understood that this device may be percutaneously implanted in any suitable part of the human body, such as a body lumen (e.g., a blood vessel) or the heart. Similarly, it should be understood that this device may be regulated in vivo after implantation in a manner that improves outcomes such as treating or improving any suitable condition such as HF, PAH, aneurysm, aortic stenosis, mitral stenosis, or following cardiac valve repair (e.g., mitral valve repair) or cardiac ablation (e.g., to treat atrial fibrillation), by regulating fluid flow. Some non-limiting embodiments of the device for implantation at a selected site are described with reference to Figures 7-16B.

[0151] In some embodiments, the device is or may include an hourglass or “diablo” shaped shunt, which may optionally be encapsulated in a biocompatible material and used to treat subjects suffering from disorders such as CHF or PAH, where regulating fluid flow with respect to such disorders may be useful. In some embodiments, the hourglass shaped shunt may be fixed and punctured into an opening through the atrial septum, for example, the fossa ovale, and may be specifically configured to allow blood flow from the left atrium to the right when the blood pressure in the left atrium exceeds that of the right atrium, or from the right atrium to the left when the blood pressure in the right atrium exceeds that of the left atrium. As provided herein and described in more detail with reference to Figures 7-10C, the internal dimensions of the hourglass shaped shunt may preferably be regulated in vivo, for example, to regulate the flow of fluid through it, for example, to regulate the flow of fluid between the left and right atria through the atrial septum.

[0152] Referring here to Figure 7, a shunt 700 having internal dimensions that can be reduced and increased in vivo is illustrated. The shunt 700 is hourglass or “diablo” shaped and may include a first component 710, a second component 720, and a third component 730, which are fluidly coupled to one another. The first component 710 may include a first self-expanding superelastic material in a manner similar to that described with reference to Figures 2A-2E, the second component 720 may include a malleable shape memory material, and the third component 730 may include a second self-expanding superelastic material. The first component 710 may include any preferred number of rings, e.g., rings 712, 713, which are formed from or include the first self-expanding material, which may optionally be sinusoidal. The second component 720 may include any preferred number of rings, for example, ring 714, which is formed from or includes a malleable shape memory material and may optionally be sinusoidal. The third component 730 may include any preferred number of rings, for example, rings 715, 716, which are formed from or include a third self-expanding material and may optionally be sinusoidal. The struts 711, 708 can join the rings of the first component 710, the second component 720, and the third component 730 to each other.

[0153] The first component 710 may provide a first expanded end region 702, the third component 730 may provide a second expanded end region 706, and the second component 720 may provide a neck region 704 located between the first and second expanded end regions. The inlet and outlet of the device 700 may include flanges 702, 706, and the neck region 704 may include flexible longitudinal bars 711, 708 and a sinusoidal ring 714. The flexible longitudinal bars 711, 708 may allow the flanges to fully expand when deployed, and the sinusoidal ring may have sufficient strength to maintain its diameter when ballooned or thermally deflated.

[0154] In the non-limiting embodiment shown in Figure 7, the first expanded end region 702 has a first end region dimension D1, the second expanded end region 706 has a second end region dimension D2, and the neck region 704 has a neck region dimension D3, which may be enlarged or reduced in a manner described with reference to the second component 220 illustrated in Figures 2A-2E. As shown in Figure 7, the neck region 704 of the shunt 700 may be significantly narrower than the expanded end regions 702 and 706, and may have, for example, a smaller cross-sectional area and smaller dimensions than the expanded end regions 702 and 706. Also, as shown in Figure 7, the shunt 700 may be asymmetrical. For example, the shunt 700 may be asymmetrical and take advantage of the natural features of the cardiac atrial septum and the left and right atrial chambers. Alternatively, the hourglass-shaped shunt 700 may be symmetrical, with the first end region dimension D1 being equal to the second end region dimension D2. The first and second expanded end regions 702 and 706 may also have either a straight or curved profile, or both. For example, the support column 711 has a straight profile, and the support column 708 has a curved profile. In addition, the first and second expanded end regions 702 and 706 may take any angular position that is consistent with the hourglass configuration.

[0155] The shunt 700 may preferably be formed in a manner as described in any part of this specification. For example, in some configurations, the shunt 700 is laser-cut from a single tube of nitinol, in a manner as described with reference to the device 600 illustrated in Figure 6, and different regions of the nitinol are heat-treated differently from each other to define a self-expanding superelastic material (one or more) and a malleable shape memory material. Thus, the first, second, and third components 710, 720, and 730 of the device 700 may optionally be integral with each other. The first and third self-expanding materials may optionally be the same material as each other. In other configurations, the first, second, and third components 710, 720, and 730 of the device 700 may be formed independently of each other and assembled together, for example, in a manner as described with reference to Figures 5A to 5B, and further illustrated with reference to Figures 11A to 12B described below. Additional voluntary modifications of the shunt 700 are described below with reference to Figures 13A-13B, 25A-25D, 26A-26H, and 27A-27K.

[0156] Figures 8A–8D schematically illustrate exemplary steps for using the device of Figure 7 within the human body. The shunt 700 may be crimped into a cylindrical shape by, for example, pushing it through a conical loading device. In one non-limiting embodiment, the shunt 700 may be crimped to an external dimension of approximately 4.6 mm, the internal dimension of a 14F Cook sheath. The sheath may be percutaneously placed at a desired location within the human body through a blood vessel, and the crimped shunt may be placed within the sheath in a manner similar to that illustrated in Figure 2A. As the crimped shunt is pushed out of the sheath, the self-expanding hyperelastic expanding end region springs open to its set configuration, while the malleable shape-memory central neck region remains constrained to its crimped dimensions or nearby, for example, in a manner as illustrated in Figure 8A, in which the neck region (designated "B" and corresponding to the second component 220) engages with an opening within the human body. Depending on the desired direction of blood flow through the device 700, one of the expanded ends (designated "A" or "C" and corresponding to the first component 210 or the third component 211) provides an inlet, and the other expanded end (designated "C" or "A" and corresponding to the third component 211 or the first component 210) provides an outlet. For example, the neck region may engage with an opening created through the fossa ovale of the interatrial septum between the right and left atria, with one of the expanded ends extending into the right atrium and the other expanded end extending into the left atrium. In some configurations, the expanded end in the right atrium is the inlet and the expanded end in the left atrium is the outlet, while in other configurations, the expanded end in the left atrium is the inlet and the expanded end in the right atrium is the outlet.

[0157] The cross-sectional area (and dimensions) of the orifice provided by the malleable shape memory central neck region may be increased or decreased to regulate the flow of fluid through the shunt 700. For example, in the manner illustrated in Figure 8B, the neck region may be expanded by balloon expansion using a balloon 801 which can be fed through the orifice using a wire 802. In addition, in the manner illustrated in Figure 8C, the neck region may be deflated by injecting a bolus of high-temperature saline solution having a temperature above the Af (e.g., 45-60°C) of the malleable shape memory material via a catheter 803, which may return the neck region to its heat-set dimensions, which may differ from its crimped dimensions, in the manner illustrated in Figure 8D.

[0158] For example, heat from saline can cause the malleable shape memory material to transition to the austenite phase, compressing the neck region back to its crimped (or otherwise heat-set) dimensions, and subsequently, the neck region is cooled to body temperature and transitions back to its martensite phase. Saline may be delivered in any preferred manner, for example, by a flexible catheter having one or more openings (e.g., one or more side holes) through which high-temperature saline can flow and which can be placed within the neck region, for example, via a guidewire. In one non-limiting embodiment, the neck region may have its crimped inner dimensions, typically 1-2 mm, in the first instance, such as when it is first unfolded in the manner illustrated in Figure 8A. The neck region may then be expanded, in a second instance, using balloon expansion to any desired larger dimension between the crimped dimension and 7 mm. The neck region may then be deflated to its heat-set dimension D0 using high-temperature saline for a third time. Dimension D0 is determined by the size of the jig used in the heat-set step during manufacturing. D0 may be greater than the dimensions of the catheter used to deliver high-temperature saline and greater than the deflated dimensions of the inflated balloon, but may be less than or equal to the minimum expected desired final shunt dimension, e.g., 4 mm. The neck region may then be expanded again, for a second time, using balloon expansion to any desired larger dimension between 4 mm and 7 mm. Any suitable number of expansions and deflations may be applied to the neck region at any desired time or at times separate from each other to provide a suitable and customized fluid flow through the device for each given patient. It should be understood that the content constituting a suitable fluid flow for a given patient may also change over time, and the device may be adjusted to suitably, i.e., as needed, to provide its fluid flow or to suitably fix the device in the lumen.Furthermore, it should be understood that the self-expanding superelastic component is not affected by the injection of high-temperature saline solution, and therefore will retain its initial fully expanded dimension while the shape memory component (in this embodiment, the neck region) is being adjusted. In addition, any preferred method for heating the shape memory material, such as RF heating or laser, magnetic inductance, electrical resistance, or equivalent, may be used in addition to or in addition to high-temperature saline solution, in the manner described with reference to Figures 1A-1E.

[0159] Specific configurations of the shunt 700 may be selected to provide desired fluid dynamics through it. For example, Figures 9A–9B schematically illustrate exemplary configurations of the device in Figure 7. In Figures 9A–9B, the geometric shapes of the inlet and outlet internal dimensions (e.g., inlet and outlet angles α and β) may be selected to regulate the fluid dynamics through the shunt 700. Apart from regulating the fluid dynamics to treat specific clinical conditions, the ability to narrow the inlet or outlet, or both, may reduce the risk of thrombus passage into or through the device lumen.

[0160] Shunt 700 (or any other device provided herein) may be constructed using any preferred combination of techniques. Figures 10A–10C schematically illustrate exemplary use of tools for preparing the device of Figure 7. As shown in Figures 10A–10C, shunt 700 (or any other device provided herein) may be heat-treated within tools 1000, which allows the component(s) to be maintained at a lower temperature than the component(s) that will become substantially malleable shape memory material, which may be exposed, for example, in region 1003 shown in Figure 10C (e.g., individually insulated or heat-sinked by dies 1001, 1002 within the tools). Thus, the exposed component(s) may receive a greater heat flux during the heat treatment, which may result in a predetermined higher Af temperature compared to the component(s) that are insulated or kept cooler by contact with a heat sink. A temperature gradient between a heated region and a cooled region can result in a transition zone between a region that is substantially martensite at body temperature (37°C) and a region that is substantially austenite at body temperature. Heat treatment may be implemented by a furnace, induction heating, electric current, or any other suitable and controllable energy source. Differences in heat flux (which may result in higher Af for one or more components that will become substantially malleable shape memory material) may also be achieved by providing components with different (thinner) wall thicknesses, for example, by material removal from a nitinol tube prior to laser cutting, or by using an additive manufacturing process to produce the device.

[0161] Tools 1000 are optional and may include any of the devices described herein (for example, device 200 as illustrated with reference to Figures 2A-2E, device 700 as illustrated with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as illustrated with reference to Figures 11A-11B, device 1210 as illustrated with reference to Figures 12A-12B, device 1300 as illustrated with reference to Figures 13A-13B, device 28 as illustrated with reference to Figures 23A-23E, and device 25A-25D). It should be understood that any of the devices described (device 2500, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C) may be suitably formed using localized heat treatment of one or more parts of each such device, which may produce a different Af from the unheated parts(s) of the device. Such localized heating of parts(s) of the device may be carried out using induction heating, for example, with optional active cooling of adjacent areas. In addition, or alternatively, such localized heating of parts(s) of the device may be carried out using localized laser heating, with optional active cooling of adjacent areas. Furthermore, it is known that the effect of heat treatment on nitinol Af is cumulative, such that the same effect as a single, longer-duration treatment at a given temperature can be produced by multiple short-duration heat treatments up to that temperature. Therefore, it is considered that a series of short, concentrated, localized laser heating pulses, with the intensity and duration of each pulse selected to raise its area within the laser beam to a desired heat treatment temperature, can be combined with active cooling, such as the flow of low-temperature argon or other suitable gas, to enable a highly localized increase in Af while maintaining lower Af in adjacent areas.

[0162] Furthermore, it should be understood that wires with different Af temperatures may be used to prepare the device. For example, in the manner described with reference to Figures 27A-27K, wires having different Af temperatures from each other, and / or wires having different Af temperatures along their length, may be used to prepare the device. Such wires may, as an example, be used to manufacture a device having multiple Af temperatures (e.g., multiple phases of nitinol) using wire winding techniques, wire mesh techniques, or any preferred combination thereof.

[0163] Furthermore, it should be understood that any suitable combination of superelastic and shape-memory nitinol components may be used within this device.

[0164] In addition, or alternatively, the shunt 700 (or any other device provided herein) may be fabricated using a multi-material additive manufacturing process. For example, a higher Af component(s) that will become a malleable shape memory material may be provided by using a selective laser melting or electron beam melting powder bed machine, which has two or more powder containers in which the machine can be switched between during the printing process. The Af of a given component may be manipulated by the chemical composition of the powder, e.g., different fractions of nickel titanium or any other element(s) that may be present. For example, the higher the nickel percentage, the higher the Af. The Af of a given component may also, or alternatively, be manipulated by the physical composition of the powder, e.g., particle size. For example, the smaller the powder size, the lower the Af. For further details on manipulating the Af of materials during multi-material additive manufacturing processes, see Horvay and Schade, “Development of nitinol alloys for additive manufacturing” (its entire contents are incorporated herein by reference). Alternatively, multi-material manufacturing may be achieved by liquid dispersion methodologies (material ejection). For example, a 3D printer may include two or more cartridges, each containing a different powder-liquid composition, in a manner similar to that described with respect to powder-based examples.

[0165] Figures 11A-11B schematically illustrate another exemplary modification of the device of Figure 7. In one specific non-limiting embodiment, the modified shunt 1100 includes an austenite phase (self-expanding superelastic) nitinol inner frame and a martensite phase (malleable shape memory) nitinol outer frame (structural member). The inner frame may include a first component 1110 (corresponding to a first expanded end region 702) and a third component 1111 (corresponding to a second expanded end region 706). The outer frame may include a second component 1120 (corresponding to a neck portion region 704). The Af of the martensite outer frame may be in the range of 45-60°C, for example, about 50-55°C. The outer frame may be localized to the shunt neck portion region (for example, about 5 mm in length) and may not extend to the atrial cones 1110, 1111. The inner and outer frames may be designed so that their respective geometric shapes mechanically interfere with each other, so that when installed together, they remain co-aligned. The martensite outer frame may be heat-set for smaller inner dimensions (e.g., 4 mm), while the austenite inner frame may be heat-set for larger orifice dimensions (e.g., 7 mm). The inner and outer frames may be constructed such that the force required to expand the outer martensite frame exceeds that produced by the superelasticity of the inner frame, so that the martensite outer frame is strong enough to accommodate the austenite inner frame dimensions at any expanded dimensions, in a manner similar to that described with reference to Figure 5B. At room temperature and body temperature, the martensite outer frame may be malleable and may be plastically deformed, for example, by gradual balloon inflation, which may expand its inner dimensions by any desired amount, for example, in the range of 4 to 7 mm, depending on the balloon dimensions and inflation pressure, e.g., up to 12 atm. The martensite outer frame may be in contact with the outer surface of the neck portion of the austenite inner frame in the radial direction to restrain the neck portion from self-expanding to a larger dimension.The neck portion self-expands in response to the martensite outer frame expanding to a larger dimension. The two co-aligned frames may be encapsulated with ePTFE or other suitable biocompatible material to create a smooth pathway for blood flow and to block the invasion of proliferative tissue during post-implantation healing. For example, the martensite outer frame may be encapsulated or unencapsulated, applied over an encapsulated inner frame, or the martensite outer frame may be applied to a bare inner frame, and both frames together, then encapsulated. The encapsulating material may form an inner lumen through a portion of the inner frame of the device (e.g., through component 1110) and an outer covering (e.g., of components 1110 and 1120).

[0166] In an alternative configuration (not specifically illustrated), the martensitic frame, including a second component 1120 (corresponding to the neck region 704), may be placed inside the outer austenitic frame, which includes a first component 1110 (corresponding to the first expanded end region 702) and a third component 1111 (corresponding to the second expanded end region 706). By using appropriate mechanical interference, such as laser spot-welded interlocking shapes, a shorter martensitic frame may be pulled inward towards the center of the outer austenitic frame when heated above Af. For example, the inner martensitic frame may radially contact the inner surface of the neck to restrain the neck from shrinking to a smaller cross-sectional area. The neck may self-shrink in response to the inner martensitic frame shrinking to a smaller cross-sectional area. The covering material may form the outer covering of the first component 1110 and the second component 1120.

[0167] However, the martensitic frame does not necessarily have to be welded to the austenite frame or otherwise directly bonded. For example, Figures 12A-12B schematically illustrate another exemplary modification 1210 of the device in Figure 7, in which a shorter martensitic frame 1120 (corresponding to the neck portion region 704) is placed inside the outer austenite frame, which includes a first component 1110 (corresponding to the first expanded end region 702) and a third component 1111 (corresponding to the second expanded end region 706), but is not directly bonded thereto. Instead, the encasing material 1140 encases both the inner martensitic frame 1120 and the outer austenite frames 1110, 1111, indirectly and elastically bonding the martensite and austenite frames to each other. In this embodiment, the heat treatment for the neck portion of the superelastic outer frame may be heat-set to the maximum dimension considered for treatment, e.g., 7 mm, rather than the minimum dimension of 4 mm as in the two embodiments described above. Because there is no direct mechanical bond between the superelastic outer austenite frame and the shape-memory inner martensitic frame, when implanted in the body, the outer frame may expand to the maximum dimension, e.g., 7 mm, or to a smaller dimension if constrained by the body (e.g., by the opening 1280 through which the device is pierced). The hoop strength of the outer austenite frame may be engineered to be slightly below the converging force of the body opening 1280, so that the outer frame can maintain contact with the opening 1280 without generating a force sufficient to cause the opening to expand. The hoop strength of the outer austenite frame may be adjusted, for example, by selecting a suitable frame tube thickness and laser-cut frame pattern. The inner malleable shape-memory frame may be stronger than the outer frame and stronger than the compressive force of the body opening 1280, and therefore, even if the inner frame is expanded to a dimension larger than the dimension of the opening 1280 of the outer frame (for example, to a dimension of 4-7 mm), as described above, it will maintain its dimensions after the inflation balloon has deflated and been removed.

[0168] Furthermore, since there is no direct attachment between the inner and outer frames within the device 1210, the inner martensitic frame 1120 can return to its original pre-expansion dimensions by the application of heat in the manner described above, as shown in Figure 12B, while the outer frame remains constrained only by contact with the opening 1280. Such a configuration can prevent or block the loss of contact between the device and the opening 1280 (such as an opening through the septum), which could otherwise result in shunt periphery leakage, which could allow for a greater-than-desirable flow of blood from one atrium to another. In addition, the internal dimensions of the device can be changed independently of the external dimensions while keeping the external dimensions in contact with the opening (for example, reducing the dimensions of the internal martensitic frame device does not change the dimensions of the external austenite frame), thus there may be a reduced, minimal, uninterrupted, or no risk to the puncture site during or after healing, and a reduced, minimal, or no risk of shedding of other tissues that may grow around the external device during the healing process, following, for example, septal puncture and device implantation, following any thrombus, pathological growth, or formation of the opening 1280.

[0169] It should be understood that the martensite outer frame of the modified shunt 1110 may include any suitable structure that is plastically deformable at body temperature and also thermally shrinkable. For example, Figures 25A–25D schematically illustrate exemplary modifications of the device of Figure 7. In one specific non-limiting embodiment, the modified shunt 2500 illustrated in Figures 25A–25D includes an austenite phase (self-expanding hyperelastic) nitinol inner frame 2510 and a martensite phase (malleable shape memory) nitinol outer frame 2520 (structural member). The inner frame 2510 may include a first component 2511 (corresponding to a first expanded end region 702) and a third component 2512 (corresponding to a second expanded end region 706). The outer frame 2520 may include a second component 2513 (corresponding to a neck portion region 704). The Af of the martensite outer frame 2520 may be in the range of 45 to 60°C, for example, about 50 to 55°C. The Af of the austenite inner frame 2510 may be below body temperature, for example, about 5 to 20°C. The outer frame 2520 may be localized to the shunt neck region 2513 (for example, it may be about 5 mm in length) and does not have to extend to the atrial cone 2511, 2512. The inner and outer frames may be designed so that their respective geometric shapes mechanically interfere with each other so that they remain co-aligned when installed together. For example, in a configuration as illustrated in Figures 25A to 25B, the outer frame 2520 may include a compression coil that has a fixed length and therefore a different number of turns in the compressed state (Figures 25A and 25C) compared to the expanded state (Figures 25B and 25D), winding around the neck region 2513, and thus may provide a variable amount of compression force in accordance with its expansion. The compression coil of the outer frame 2520 may be substantially cylindrical, as shown in Figures 25A to 25D.

[0170] For example, in a manner similar to that described with reference to Figures 11A-11B, the martensite outer frame 2520 may be coiled and heat-set for a smaller inner dimension (e.g., 4 mm), while the austenite inner frame 2510 may be heat-set for a larger orifice dimension (e.g., 7 mm), and the outer frame 2520 may later be physically attached to the inner frame 2510. In environments below the Af of the outer frame 2520, the coil of the outer frame may be straightened, and one end thereof may then be physically attached to the inner frame 2510, for example, via a locking mechanism or equivalent. The attached inner and outer frames 2510, 2520 may then be constrained within a fixture, which is exposed to high temperatures (e.g., placed in an oven) to return the pre-straightened coil of the outer frame 2520 to its coiled shape and wind it around the inner frame 2510.

[0171] The inner and outer frames 2510, 2520 may be constructed such that the force required to expand the outer martensitic frame exceeds that produced by the superelasticity of the inner frame, in a manner similar to that described with reference to Figure 5B, such that the martensitic outer frame is sufficiently strong to accommodate the austenite inner frame dimensions at any expanded dimensions. In the compressed state illustrated in Figure 25A, the compression coil of the outer frame 2520 may be wound around the neck region 2513 by a first number of turns, exerting a relatively large compressive force on the inner frame 2510. At room temperature and body temperature, the martensitic outer frame 2520 may be malleable and may be plastically deformed, for example, by gradual balloon inflation, which may expand its inner dimensions by any desired amount, for example, in the range of 4 to 7 mm, depending on the balloon dimensions and the inflation pressure, e.g., up to 12 atm. The martensite outer frame 2520 may contact the outer surface of the neck portion of the austenite inner frame 2510 in the radial direction to restrain the neck portion from self-expanding to a larger dimension. In response to the martensite outer frame 2520 expanding to a larger dimension, the neck portion 2513 of the inner frame 2510 self-expands. In the expanded state, as illustrated in Figure 25B, the number of coil windings of the outer frame 2520 around the inner frame 2510 is reduced, which in turn reduces the compressive force exerted by the outer frame on the inner frame 2510. The variable compressive force exerted by the outer frame 2520 may be engineered to balance the outward force on the inner frame 2510, which is maximum when the inner frame is compressed to a small diameter and can become negligible when the inner frame reaches its heat-set diameter.Increased compression of a shunt (for example, as illustrated in Figure 25A) can be compensated to maintain the shunt in a compressed state using an increased force, such as an increased number of overlapping coils (for example, as illustrated in Figure 25C), while reduced compression of a shunt (for example, as illustrated in Figure 25B) can be compensated to maintain the shunt in a compressed state using a reduced force, such as a reduced number of overlapping coils (for example, as illustrated in Figure 25D).

[0172] In a manner similar to that described with reference to Figures 11A-11B, the inner frame 2510 may be encapsulated with ePTFE or other suitable biocompatible material to create a smooth pathway for blood flow and to block the invasion of proliferative tissue during post-implantation healing. A martensite outer frame 2520, which may or may not be encapsulated, may be applied over the encapsulated inner frame 2510. In one non-limiting embodiment, the outer frame 2520 may be independently coated with, for example, a relatively thin film (e.g., about 0.005 inches) of PTFE, while the outer frame is in a straightened state prior to coiling. Such a coating may prevent tissue adhesion while allowing the outer frame 2520 to coil and decoil relative to the encapsulated inner frame 2510.

[0173] Figures 26A–26H schematically illustrate another exemplary modification of the device of Figure 7. In one specific non-limiting embodiment, the modified shunt 2600 illustrated in Figures 26A–26H comprises an austenite phase (self-expanding hyperelastic) nitinol inner frame 2610 and a martensite phase (malleable shape memory) nitinol outer frame 2620 (structural member). The inner frame 2610 may include a first component 2611 (corresponding to a first expanded end region 702) and a third component 2612 (corresponding to a second expanded end region 706). The outer frame 2620 may include a second component 2613 (corresponding to a neck portion region 704). The Af of the martensite outer frame 2620 may be in the range of 45–60°C, for example, about 50–55°C. The Af of the austenite inner frame 2610 may be below body temperature, for example, about 5-20°C. The outer frame 2620 may be localized to the shunt neck region 2613 (for example, it may be about 5 mm in length) and does not have to extend to the atrial cone 2611, 2612. The inner and outer frames may be designed so that their respective geometric shapes mechanically interfere with each other so that when they are installed together they remain co-aligned. For example, in the manner illustrated in Figures 26A-26D, the outer frame 2620 may include a compression spring having a fixed length and therefore winding around the neck region 2613 with a different number of turns in the compressed state (Figures 26A-26D) compared to the expanded state (Figures 26E-26H), and therefore providing a variable amount of compressive force in accordance with its expansion. The compression spring of the outer frame 2620 may include a hook 2621 that holds the spring in place relative to the inner frame 2610. The compression spring outer frame 2620 may be non-cylindrical, and may be diabolo-shaped, for example, as shown in Figures 26A to 26H.

[0174] In a manner similar to that described with reference to Figures 11A-11B, the martensite outer frame 2620 may be heat-set for a smaller inner dimension (e.g., 4 mm), while the austenite inner frame 2610 may be heat-set for a larger orifice dimension (e.g., 7 mm). The inner and outer frames 2610, 2620 may be constructed such that, in a manner similar to that described with reference to Figure 5B, the force required to expand the outer martensite frame exceeds that produced by the superelasticity of the inner frame, so that the martensite outer frame is sufficiently strong to accommodate the austenite inner frame dimensions at any expanded dimension. In the compressed state illustrated in Figure 26A, the compression spring of the outer frame 2620 may be wound around the neck portion region 2613 by a first number of turns, exerting a relatively large compressive force on the inner frame 2610. At room temperature and body temperature, the martensite outer frame 2620 may be malleable and may be plastically deformed, for example, by gradual balloon inflation, which may expand its inner dimensions by any desired amount, for example, within the range of 4 to 7 mm, depending on the balloon dimensions and the inflation pressure, for example, up to 12 atm. The martensite outer frame 2620 may be in contact with the outer surface of the neck portion of the austenite inner frame 2610 in the radial direction to restrain the neck portion from self-expanding to a larger dimension. In response to the expansion of the martensite outer frame 2620 to a larger dimension, the neck portion 2613 of the inner frame 2610 self-expands. In the expanded state, as illustrated in Figures 26D to 26H, the number of spring coils of the outer frame 2620 around the inner frame 2610 is reduced, which in turn reduces the compressive force exerted by the outer frame on the inner frame 2610. The variable compressive force exerted by the outer frame 2620 may be engineered to balance the outward force on the inner frame 2610, which is maximum when the inner frame is compressed to a small diameter and can become negligible when the inner frame reaches its heat-set diameter.Increased compression of a shunt (as illustrated in Figures 26A-26D, for example) can be compensated to maintain the shunt in a compressed state using an increased force, such as an increased number of spring coils (as illustrated in Figure 26D, for example), while reduced compression of a shunt (as illustrated in Figures 26E-26H, for example) can be compensated to maintain the shunt in a compressed state using a reduced force, such as a reduced number of spring coils (as illustrated in Figure 26H, for example).

[0175] In a manner similar to that described with reference to Figures 11A-11B, the inner frame 2610 may be encapsulated with ePTFE or other suitable biocompatible material to create a smooth pathway for blood flow and to block the invasion of proliferative tissue during post-implantation healing. In a manner similar to that described with reference to the outer frame 2520, the martensite outer frame 2620, which may or may not be encapsulated, may be applied over the encapsulated inner frame 2610.

[0176] Figures 27A–27K schematically illustrate another exemplary modification of the device of Figure 7. Turning first to Figures 27A–27E, which show the device 2700 in its expanded state, the device may include a diabolo-shaped shunt 2700 manufactured from multiple lengths of wires 2730, e.g., about 3 to about 12 wire pieces, e.g., 6 wire pieces in the non-limiting embodiments shown in Figures 27A–27D. In some embodiments, one or more portions of one or more wires 2730 of the device 2700 may contain or be formed from austenite phase (self-expanding hyperelastic) nitinol, while one or more other portions of the wires may contain or be formed from martensite phase (malleable shape memory) nitinol. In addition, or alternatively, one or more individual wires 2730 of device 2700 may entirely contain or be formed from austenite phase (self-expanding superelastic) nitinol, while one or more other individual wires 2730 may entirely contain or be formed from martensite phase (malleable shape memory) nitinol. The wires 2730 may be wound or welded together in such a manner that the shunt 2710 includes a first component 2711 (corresponding to the first expanded end region 702), a second component 2713 (corresponding to the neck portion region 704), and a third component 2712 (corresponding to the second expanded end region 706). The Af of the martensite second component 2713 may be in the range of 45 to 60°C, for example, about 50 to 55°C. The Af of the first and second austenite components 2711 and 2712 may be below body temperature, for example, about 5 to 20°C. The wire 2730 may be configured to localize the martensite phase in the shunt neck region 2713 (for example, it may be about 5 mm in length) and the austenite phase in the atrial cone portions 2711 and 2712.

[0177] In a manner similar to that described with reference to Figure 7, the martensite region 2713 may be heat-set for a smaller internal dimension (e.g., 4 mm) or plastically deformed for a larger internal dimension (e.g., 7 mm), depending on the balloon dimensions and the inflated pressure, e.g., up to 12 atm. In a manner similar to that described anywhere in this specification, the shunt 2710 may be encapsulated with ePTFE or other suitable biocompatible material to create a smooth pathway for blood flow and to block the intrusion of proliferative tissue during post-implantation healing.

[0178] Each of the wires 2730 may have any preferred configuration. For example, in the manner illustrated in Figure 27E, each individual wire 2730 may have first and second ends that are suitably joined to each other in region 2731, for example, by overlapping, welding, or across a swaged tube as illustrated in Figure 27F. Alternatively, as illustrated in Figure 27F, one or more of the wires 2730 may be joined to each other, and / or one or more portions of a given wire may be joined to one or more other portions of the same wire using a winding 2733. Alternatively, as illustrated in Figure 27F, one or more of the wires 2730 may be joined to each other, and / or one or more portions of a given wire may be joined to one or more other portions of the same wire using a sleeve 2732. As an example, the sleeve 2732 may contain or be fabricated from a radiopaque material that would be visible under X-rays, such as platinum or tantalum. It should be understood that such a radiopaque sleeve 2732 can easily visualize the features of the device 2700 using X-ray imaging, and thus facilitate the positioning of the device 2700 in vivo and the proper expansion / contraction of the inner diameter of the neck region 2713.

[0179] In addition, or alternatively, one or more of the wires 2730 may contain a radiopaque material such as platinum or tantalum. For illustrative purposes, in the embodiment shown in Figure 27G, the wire 2730 may include an inner core 2740 formed from or containing a radiopaque material, and a plurality of strands 2741 surrounding the inner core, which are formed from or contain nitinol in a martensite or austenite phase, depending on the location of the given portion of the wire within the device 2700. Alternatively, in the embodiment shown in Figure 27H, the wire 2730 may include an inner core 2743 formed from or containing a radiopaque material, and an upper layer 2742 surrounding the inner core, which are formed from or contain nitinol in a martensite or austenite phase, depending on the location of the given portion of the wire within the device 2700. Alternatively, in the embodiment shown in Figure 27I, the wire 2730 may include an inner core 2744 formed from or containing nitinol in a martensite or austenite phase, depending on the location of that portion of the wire within the device 2700, and an upper layer 2745 formed from or containing a radiopaque material, surrounding the inner core. It should be understood that each wire 2730 may be made from various raw materials to give any preferred combination of features such as superelasticity, plasticity, and / or radiopaqueness, and may have any preferred configuration, including a stranded wire structure (e.g., Figure 27G) or a drawn-filled tube (DFT) structure (e.g., Figures 27H-27I).

[0180] In addition, or alternatively, each given portion of each wire 2730 may be suitably heat-treated before and / or after being used to construct the device 2700. For example, Figure 27J illustrates a wire 2730 having a first end 2751 and a second end 2752, and having multiple martensite phase divisions (high Af) and multiple austenite phase divisions (low Af) along its length. As an example, the martensite and austenite phase divisions may be alternating such that different zones of the formed wire have either martensite phase (Af above body temperature) or austenite phase (Af below body temperature) when the wire 2730 is formed in the manner illustrated in Figure 27K so as to form part of the device 2700.

[0181] Another method for providing a device whose internal dimensions can be reduced in vivo is to place the shunt inside another shunt. This “shunt-in-shunt” approach may be useful in situations where it is desired, for example, to modify the internal shunt at any time after the external shunt has been implanted. For example, Figures 13A–13B schematically illustrate another exemplary modification of the device of Figure 7, which includes the “shunt-in-shunt” arrangement. Figure 13A illustrates an exemplary cylindrical shunt 1360, for example, an Advanta V12 balloon expandable covered stent, which is PTFE-encased and commercially available from Getinge AB (Gothenburg, Sweden), which may be used as the internal shunt. In a manner as illustrated in Figure 13B, the device 1300 may include a shunt 1360 which is placed inside a shunt 700, as described with reference to Figure 7. In some embodiments, the inner shunt 1360 and the outer shunt 700 may be encapsulated independently of each other, separable from each other, and optionally embedded independently of each other. The inner shunt 1360 may contain a malleable shape memory material, and the outer shunt 700 may contain a self-expanding superelastic material.

[0182] For example, the external shunt 700 may initially be implanted in the patient and may have a neck portion dimension that is initially expected to be suitable for the patient. If, at a later time, it can be determined that a different neck portion dimension would be more suitable for the patient, the internal shunt 1360 may be implanted within the external shunt 700 to provide its own neck portion dimension, which may be smaller or larger than the neck portion dimension of the external shunt 700. The internal shunt 1360 may be expanded and flexibly contracted in a manner that defines the rate at which fluid flows through the device 1300. For example, if it is desired to increase the rate at which fluid flows through the device 1300, the internal shunt 1360 may be selected to have a larger dimension than the device 700 and sufficient hoop strength to suitably expand the dimensions of the device 700 and any opening through which the device 700 can be punctured. In such embodiments, the inner shunt 1360 does not necessarily have to include a malleable shape memory material, but instead may include a self-expanding superelastic material that can be heat-set to have a maximum neck portion dimension of a suitable size and expanded ends, each in contact with an expanded end for the outer shunt 700 to prevent blood flow between the two shunts. In another embodiment, the inner shunt 1360 may include a neck portion with a malleable shape memory material, with a minimum heat-set neck portion dimension of a suitable size, and expanded ends of self-expanding superelastic material, each in contact with an expanded end for the outer shunt 700 to prevent blood flow between the two shunts. The size of the neck portion of the inner shunt 1360 may be increased and decreased as described elsewhere in this specification. Optionally, the internal shunt 1360 may be implanted at the same time as the external shunt 700, for example, located within the external shunt 700, and both shunts may be crimped together, delivered through a sheath, and both may be deployed simultaneously through the sheath.

[0183] It should be understood that this device may be used in any suitable part(s) of the human body and is not limited to transatrial shunts. For example, Figures 14A–14C schematically illustrate another exemplary device with multiple internal dimensions that can be reduced and increased in vivo, and embodiments of its use in the human body. Device 1400, illustrated in Figures 14A–14C, may be used, for example, to treat an abdominal aortic artery aneurysm 140 (AAA). Device 1400 comprises a self-expanding superelastic material which comprises one or more components, including a component (designated "B") and malleable shape memory materials (designated "A" and "C"), respectively, which may be positioned within the AAA 140. Components A and C may have smaller dimensions than component B when initially implanted. Device 1400 may be delivered percutaneously by using a crimping machine to crimp the device into a cylindrical shape, placing it within a sheath, and delivering it to the desired location (abdominal aorta-pararenal) via the external iliac artery over a guidewire 1401. The crimped device 1400 may be implanted as shown in Figure 14A, with its distal end (component A) below the renal orifice and component B within AAA140. Following implantation, component A may be expanded (e.g., using balloon 1402 expansion) in a manner as shown in Figure 14B to prevent leakage of blood between the device and the blood vessel and to secure the device in the desired position.

[0184] In some cases, following implantation, the internal dimensions of the blood vessel may increase, which may result in intravascular leakage. To seal such intravascular leakage or for any other desired purpose, component C may be expanded (e.g., using balloon 1403 expansion). Thus, fluid flowing through AAA 140 may be shunted through device 1400 in such a manner that the risk of AAA rupture is reduced. If it is desired to move device 1400, the dimensions of components A and C may be reduced by applying heat in a manner as described elsewhere herein. Device 1400 may then be removed or moved to a new location as desired, and the dimensions of one or both of components A and C may be expanded again to secure the device within the blood vessel. It should be understood that the shape memory material of component C (corresponding to the third component 321) may have a first cross-sectional area which may be expanded, shrunk (e.g., to the heat-set dimensions), and then re-expanded. The cross-sectional areas of components A (corresponding to the second component 320) and C may be identical to each other, but are not necessarily required. Component A (corresponding to the second component 320) may be configured as an inlet, and component C (corresponding to the third component 321) may be configured as an outlet fluidly coupled to the inlet via component B (corresponding to the first component 310). Component A may be configured to engage with a blood vessel in the human body in the manner illustrated in Figures 14A-14C, and component C may be configured to extend into the mouth of the blood vessel. The fourth component C may extend into the mouth of a different blood vessel in the manner illustrated in Figures 14A-14C. In one embodiment, when the device 1400 is first positioned in the blood vessel, and component B is fully expanded and components A and C are compressed (compressed), after ensuring the orientation of component B and that the side branch artery is not occluded, components A and C may be released in a controlled manner.

[0185] Figures 15A–15D schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its use in the human body. Device 1500, illustrated in Figures 15A–15C, may be used, for example, to treat a fenestrated AAA150. Device 1500 each includes a self-expanding superelastic material (designated "A" and "C"), one of which may be positioned within the AAA150, and a malleable shape memory material (designated "B"). Components A and C may have larger dimensions than component B when initially implanted. Device 1500 may be delivered percutaneously by using a crimping machine to crimp the device into a cylindrical shape, placing it in a sheath, and delivering it to the desired location (abdominal aorta-adrenal gland) via a guidewire 1501 through the external iliac artery. The crimped device 1500 may be implanted such that its distal end (component A) is above the renal orifice 150, component B is adjacent to the renal orifice, and component C is inside the AAA150, as shown in Figure 15A. The smaller initial lateral dimensions of component B may facilitate the positioning of the guidewire into the renal artery. Following the positioning of the guidewire, the renal stents 1550 and 1560 may be inserted into the renal artery, respectively, via an introducer, as shown in Figure 15B. While the sheath is in place, component B may be balloon-inflated, as shown in Figure 15C. If the position of the guidewire is lost at this stage, the dimensions of component B may be reduced by the application of heat. Following the expansion of component B, the covered stent may be deployed in the renal artery. The stents 1550 and 1560, together with device 1500, may provide a fenestrated intravascular graft and repair the AAA150 following the removal of the sheath, as shown in Figure 15D. Therefore, the fluid flowing through AAA150 can be shunted through device 1500, which is supported by stents 1550 and 1560 in a manner that reduces the risk of AAA rupture.In addition, compared to devices known to date, device 1500 may provide an expandable central compartment B, which may, beneficially, reduce blood flow velocity and turbulent flow.

[0186] Figures 16A–16B schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its use in the human body. Device 1600, illustrated in Figures 16A–16B, may be used, for example, to provide an aortic or mitral valve replacement device, or to close the left atrial appendage (LAA). Device 1600 includes a component (designated "A") comprising a self-expanding superelastic material that can be positioned within a desired portion of a blood vessel such as the aortic artery, and a component (designated "B") comprising a malleable shape memory material. Component B may have smaller dimensions than component A when initially implanted. Device 1600 may be delivered percutaneously by crimping the device into a cylindrical shape using a crimping machine, as shown in Figure 16A, placing it in a sheath, and delivering it to the desired location through a blood vessel via a guidewire 1601. Following implantation, component B may be expanded (e.g., using balloon 1602 expansion) in a manner such as that shown in Figure 16B to prevent leakage of blood between the device and the blood vessel and to secure the device in the desired position. Thus, fluid flowing through the blood vessel can be shunted through device 1600 in a manner such as that which treats a patient, for example, to replace an aortic or mitral valve, or to close a laryngeal aorta (LAA). If it is desired to move device 1600, the dimensions of component B may be reduced by applying heat in a manner such as that which is described elsewhere in this specification. Device 1600 may then be removed or moved to a new location as desired, and the dimensions of component B may again be expanded to secure the device within the blood vessel. In configurations in which it is desired to replace a valve such as an aortic or mitral valve, device 1600 may include a valve located within either component A or component B. For example, component A may be configured to engage with a blood vessel in the manner shown in Figures 16A to 16B, and component B may extend into the blood vessel and include a valve located therein.

[0187] It should be understood that any of the devices provided herein may be used in methods for tuneably adjusting fluid flow, and are not necessarily limited to the embodiments shown in particular. For example, Figure 17 illustrates the flow of operation in exemplary method 1700 for reducing and increasing the dimensions of a device in vivo. Method 1700 may include inserting (1701) first and second components coupled together into a flow path. The first component may include a self-expanding hyperelastic material, and the second component may include a malleable shape memory material having a first cross-sectional area. Such first and second components, as well as non-limiting embodiments of their optional configurations, are illustrated with reference to Figures 1A-1E, 2A-2E, 3A-3D, 4A-4B, 5A-5B, 6, 7, 8A-8D, 9A-9B, 11A-11B, 12A-12B, 13A-13B, 14A-14C, 15A-15D, 16A-16B, 23A-23E, 25A-25D, 26A-26H, 27A-27K, 28A-28D, 29A-29D, and 30A-30C.

[0188] As illustrated in Figure 17, method 1700 may also include expanding the malleable shape memory material to a second cross-sectional area (operation 1702). For example, as described elsewhere in this specification, the malleable shape memory material may be expanded using balloon expansion.

[0189] As illustrated in Figure 17, method 1700 may include shrinking the malleable shape memory material to a third cross-sectional area (operation 1703). For example, as described elsewhere in this specification, the malleable shape memory material may be shrunk using heat, such as by using saline solution heated above the Af of the shape memory material, or by using another suitable energy source such as radio frequency electrical current (RF).

[0190] Therefore, in the embodiments provided herein, the fluid flow path through the implantable device may be enlarged and reduced following implantation, allowing for repositioning of the device or customized fluid flow to suit the specific patient's needs. In comparison, with devices known to date, repositioning may not be possible, and the size of the fluid flow path may be selected prior to implantation or enlarged using balloon expansion, providing limited options for achieving desired hemodynamic outcomes in the patient. In embodiments such as those provided herein, the component(s), including one or more self-expanding superelastic materials, may immediately assume their shape upon implantation in the body, thereby preventing device migration and ensuring precise positioning. The component(s), including one or more malleable shape memory materials, may be plastically deformable at body temperature (e.g., expandable) and return to their heat-set dimensions upon application of heat. The heat-set dimensions of the malleable shape memory component may optionally be larger than the crimped dimensions of the component. Therefore, in some embodiments, the malleable shape memory component may be expanded, for example, by applying heat as an alternative to initial balloon expansion after delivery of the crimped device. The malleable shape memory component(s) may be repeatedly expanded and contracted, which may allow for regulation of the fluid flowing through the device, or repositioning of the device, or a combination of such features.

[0191] For example, some of the devices provided herein may be repositionable for fixation within a body lumen. As described above, the device may include a first component comprising a self-expanding superelastic material, in a manner described with reference to Figures 1A-1E, 2A-2E, 3A-3D, 4A-4B, 5A-5B, 6, 7, 8A-8D, 9A-9B, 11A-11B, 12A-12B, 13A-13B, 14A-14C, 15A-15D, 16A-16B, 23A-23E, 25A-25D, 26A-26H, 27A-27K, 28A-28D, 29A-29D, and 30A-30C, and a second component coupled to the first component comprising a malleable shape memory material. The self-expanding superelastic material may have a predetermined fully expanded dimension (e.g., it may be heat-set during manufacturing). The second component may have a first dimension for suitable deployment through a catheter (e.g., it may be crimped to that dimension). The malleable shape memory material may be expandable to a second dimension for fixation in a body lumen (e.g., via balloon expansion) and may be thermally transitionable to a third dimension (e.g., via the application of heat in the body, as described elsewhere in this specification). The malleable shape memory material may be mechanically re-expandable to a fourth dimension (e.g., via balloon expansion).

[0192] Therefore, it should be understood that some of the devices provided herein are not necessarily limited to the embodiments specifically illustrated, and may be used in methods for repositioning devices within body tubules. For example, Figure 18 illustrates the flow of operations in exemplary method 1800 for repositioning a device. Method 1800 includes inserting a device having first and second components coupled together into a body tubule (operation 1801). The first component may include a self-expanding superelastic material in a manner described with reference to Figures 1A-1E, 2A-2E, 3A-3D, 4A-4B, 5A-5B, 6, 7, 8A-8D, 9A-9B, 11A-11B, 12A-12B, 13A-13B, 14A-14C, 15A-15D, 16A-16B, 23A-23E, 25A-25D, 26A-26H, 27A-27K, 28A-28D, 29A-29D, and 30A-30C, and the second component may include a malleable shape memory material having the first dimensions.

[0193] Method 1800 also includes, for example, expanding the malleable shape memory material to a second dimension via balloon expansion and securing the device within a body lumen (operation 1802). Method 1800 also includes, for example, thermally shrinking the malleable shape memory material via the application of heat (operation 1803). Method 1800 also includes, while the malleable shape memory material is thermally shrinking, repositioning the device within a body lumen by, for example, moving the device along a guide wire (operation 1804). Method 1800 also includes, for example, mechanically re-expanding the malleable shape memory material to a third dimension via balloon expansion and securing the device within a body lumen (operation 1805).

[0194] It should be understood that some embodiments provided herein relate to permanently implantable devices for use in the human body, while other embodiments relate to devices for temporary use only within the human body. In addition, it should be understood that some embodiments herein primarily relate to changing the internal dimensions of the device, while other embodiments primarily relate to changing the external dimensions of the device. For example, Figures 19A–19D schematically illustrate an exemplary dilator device 1900 with certain external dimensions that can be reduced and increased within the body. Device 1900 may be used in a “sheathless” method for delivering a permanently implantable device to a suitable location within the human body, for example, using an over-the-wire (OTW) approach, as described with reference to Figures 20A–20I.

[0195] In the embodiment shown in Figure 19A, the device 1900 may include a dilator 1910 positioned at the distal end of the sheath 1920. As shown in more detail in Figure 19B, the dilator 1910 may include a tip 1911, an expanding region 1912, and a contracting region 1913. The contracting region 1913 may be sized to engage securely with the distal end of the sheath 1920, and the expanding region 1912 may be sized to provide the device 1900 with a smooth profile between the sheath 1920 and the tip 1911. The tip 1910 may have an outer dimension d such that the tip 1911 abuts against the expanding region 1912, and its distal end may be tapered to approximately a point. In the exemplary configuration shown in Figure 19B, the dilator 1910 includes a martensitic shape memory material defining an expanding region 1912 and a contracting region 1913 (both indicated as region B), and a self-expanding hyperelastic material defining a tip 1911 (indicated as region A). The austenite termination temperature (Af) of the self-expanding hyperelastic material may be below body temperature (approximately 37°C), for example, in the range of 5 to 15°C. The Af of the martensitic shape memory material may be substantially above 37°C, for example, in the range of approximately 45 to 60°C, for example, in the range of approximately 50°C. The tip 1910, the contracting region 1913, and the expanding region 1912 are optionally integrally formed from a common frame with respect to each other.

[0196] As shown in Figure 19C, upon application of heat (e.g., using high-temperature saline solution or RF energy or laser, magnetic inductance, electrical resistance, or equivalent), the shape memory material in region B (corresponding to the expanding region 1912 and the shrinking region 1913) can optionally revert to smaller heat-set outer dimensions, which may be approximately equal to d, so that the dilator 1910 has a substantially smooth, reduced size profile. In the alternative configuration shown in Figure 19D, the dilator 1910' includes a martensitic shape memory material defining the tip 1911, the expanding region 1912, and the shrinking region 1913, which can optionally revert to smaller heat-set outer dimensions, which may be approximately equal to d, so that the dilator 1910 has a substantially smooth, reduced size profile.

[0197] Figures 20A–20I schematically illustrate the use of the delivery device 1900 of Figures 19A–19D within the human body. In the non-limiting embodiment shown in Figure 20A, a guidewire 2020 is placed percutaneously across a region of the body to be inflated, for example, the fossa ovalis 2010 of the interatrial septum 2000, creating a small opening having approximately the dimensions of the guidewire 2020. The device 1900 is then advanced across the guidewire 2020 to a position adjacent to the fossa ovalis 2010, in a manner as illustrated in Figure 20B. Pushing the proximal end of the sheath 1920, as shown in Figure 20C, pushes the dilator 1910 through the fossa ovalis 2010, expanding the opening to approximately the outer dimensions of the inflated region 1912. As shown in Figure 20D, the sheath 1920 may be retracted relative to the dilator 1910, leaving the dilator 1910 in a fixed position distal to the fossa ovale 2010. When retracting the dilator 1910, heat may be applied distal to the fossa ovale 2010, as shown in Figure 20E, for example, by applying high-temperature saline or RF energy or laser, magnetic inductance, electrical resistance, or equivalent, at a temperature above Af of the shape memory material of the dilator, in order to prevent damage to the tissue of the interatrial septum 2000 by trapping tissue in the enlarged region 1912 when the dilator 1910 is retracted, and to prevent the dilator 1910 from trapping or becoming confounded with an expandable device that may be delivered across such a septum. Such heat causes the outer dimensions of the enlarged region 1912 to return to its heat-set size. As shown in Figure 20G and its insert 20H, the reduced-size dilator 1910 can be safely removed through the enlarged opening in the manner illustrated in Figure 20I, then housed inside the sheath 1920, and subsequently removed from the body. It should be noted that any preferred one of the adjustable devices described anywhere in this specification, such as devices 700, 1100, 1300, or 2100, may be delivered using the delivery device 1900.For example, the adjustable device may be positioned within the sheath 1920 and advanced together with the delivery device 1900 so as to partially cross the atrial septum, as shown in Figure 20C. Retracting the sheath 1920, as shown in Figure 20D, deploys the distal shunt flange of the adjustable device in the left atrium, then pulls the sheath back against the septal wall, releasing the retention hook, and pulls the sheath further back so that the septum pulls the remainder of the shunt out of the sheath, allowing the proximal flange of the shunt to self-expand in the right atrium. The dimensions of the dilator 1910 are then adjusted in vivo and removed through the adjustable device, thus providing a “sheathless” implantation procedure with a relatively low crossover profile and a relatively short procedure time.

[0198] Figures 21A–21D schematically illustrate exemplary transatrial gates 2100 with internal dimensions that can be reduced and increased in vivo. As illustrated in the cross-sectional area in Figure 21A, the transatrial gates 2100 may be positioned across an opening through the interatrial septum 2000, for example, through the fossa ovale 2010. The transatrial gates 2100 each include left and right atrial disks (indicated as "A" in Figures 21A–21D) containing a self-expanding superelastic material, and a martensite shape memory material (indicated as "B" in Figures 21A–21D) having an Af substantially higher than body temperature, e.g., 45–60°C, e.g., 50–55°C. The left atrial disk A, the right atrial disk A, and the martensite shape memory material are optionally integrally formed from a common frame with respect to each other. In one embodiment, the martensite shape memory material B may be provided as a mesh that forms internal dimensions that can be contracted and expanded in vivo. For example, as shown in Figure 21B, the martensite shape memory material B may be heat-set to completely occlude the passage between the left and right atrial disks A, corresponding to an internal dimension of approximately zero. As shown in Figure 21C, the martensite shape memory material B may be mechanically expanded to provide any preferred expanded internal dimensions, allowing passage between the left and right atrial disks A. As shown in Figure 21D, depending on the heating above Af, the martensite shape memory material may revert to its heat-set configuration.

[0199] Figures 22A–22H schematically illustrate the use of the transatrial gate shown in Figures 21A–21D within the human body. In an exemplary use of the transatrial gate 2100 as an independent adjustable transatrial shunt, the guidewire 2220 is used to perform a transseptal puncture voluntarily through the fossa ovale 2210, as shown in Figure 22A. The opening through the atrial septum 2200 may be expanded voluntarily, as shown in Figures 22B–22D, using an introducer sheath and dilator (not shown), or by advancing a non-responsive balloon 2201 across the guidewire 2220 and then expanding the balloon. In one non-limiting embodiment, the balloon has a maximum outer dimension of 15 mm, but any preferred dimension may be used. The balloon or dilator is then removed, while keeping the guidewire 2220 in place, as shown in Figure 22E. The adjustable transatrial gate 2100 is embedded by, for example, advancing the gate 2100, which is crimped into the sheath 2230, through a guidewire, partially through the atrial septum, in a manner such as that shown in Figure 22F, and then retracting the sheath 2230 in a manner such as that shown in Figure 22G, thereby allowing the distal end (left side in the illustrated configuration) of the gate 2100 to unfold through the self-expansion of the left atrial disk A. The sheath is then further retracted in a manner such as that shown in Figure 22H, thereby allowing the proximal end (right side in the illustrated configuration) of the gate 2100 to unfold through the self-expansion of the right atrial disk A. The guidewire 2220 may be left through the gate 2100. The gate is then crossed with a dilator having a preferred outer dimension of, for example, 5 mm, which mechanically expands the inner dimension of the martensitic shape memory material B to the outer dimension of the dilator, for example, 5 mm. The internal dimensions of martensitic shape memory material B may then be further increased as needed, for example, by similar mechanical expansion using a larger dilator. If the internal dimensions of martensitic shape memory material B are determined to be too large, they may be heated above their Af and the material reset to its heat-set configuration. The internal dimensions of the material may then be expanded to another suitable size.

[0200] In an exemplary use of the transatrial gate 2100 as an openable and closable transatrial channel, a guidewire is used to perform a transseptal puncture. The opening, voluntarily through the atrial septum and the fossa ovale, may be dilated using an introducer sheath and dilator. The dilator is then removed while keeping the sheath in place. Procedures such as RF ablation, left atrial appendage (LAA) closure, MitraClip implantation, mitral valve replacement, mitral valve repair, or equivalent may then be performed in the left atrium through the dilated opening. The adjustable transatrial gate is implanted in a manner as described with reference to Figures 21A–21H, for example, of martensite shape memory material in its heat-set state with minimal or zero internal opening. Optionally, a guidewire is left through the gate, which is then crossed with a dilator having a preferred outer dimension of, for example, 5 mm, which mechanically expands the inner dimension of the martensite shape memory material B to the outer dimension of the dilator, for example, 5 mm. The inner dimension of the martensite shape memory material B may then be further increased as needed, for example, by similar mechanical expansion using a larger dilator. If the inner dimension of the martensite shape memory material B is determined to be too large, it may be heated above its Af and the material may be reset to its heat-set configuration. The inner dimension of the material may then be expanded to another preferred size. The gate may be left open in the manner described above and used to provide a transatrial shunt, or it may be left closed but may be reopened as needed to allow for separate procedures to be performed later in the left atrium.

[0201] As described above, the device may be implanted in the body permanently or temporarily. In temporary implantation, the device may be configured for easy removal and may have adjustable dimensions in a manner as described elsewhere herein, or may be permanently connected to the end of a catheter. For example, Figures 23A–23E schematically illustrate exemplary devices with internal dimensions that can be reduced and increased in vivo, and embodiments of their temporary use in the human body. More specifically, Figure 23A is a schematic diagram of a temporary device 28 inside a subject 20 according to several embodiments provided herein, Figure 23B is a schematic diagram of the temporary device 28, and Figures 23C–23E collectively illustrate techniques for removing the temporary device 28 from a subject according to several embodiments provided herein.

[0202] Apparatus 28 includes device 21, which may be configured similarly to device 200 described with reference to Figures 2A-2B or device 700 described with reference to Figure 7, and may be placed between two ventricles 22 of subject 20, such as within the interatrial septum 24 of the heart 22 between the right atrium 30 and the left atrium 32. Alternatively, device 21 may be placed between two ventricles of the heart or between any two other body cavities. In the embodiment illustrated in Figure 23B, device 21 includes an expanded distal portion 40, an expanded proximal portion 44, and an intermediate portion 42 positioned between the distal portion 40 and the proximal portion 44. The distal portion 40 and the proximal portion 44 keep device 21 in place in the septum 24 (i.e., prevent the device from migrating out of the septum), while the intermediate portion 42 provides a passage across the septum through which blood can flow. In a manner similar to that described with reference to Figures 2A-2B and Figure 7, the expanded distal portion 40 (first component) may include a first self-expanding material, the intermediate portion 42 (second component) may include a malleable shape-memory material, and the proximal portion 44 (third component) may include a second self-expanding material. The proximal portion 44, distal portion 40, and intermediate portion 42 are optionally integrally formed from a common frame with respect to each other. The expanded distal and proximal portions 40, 44 (first and third components) of the device 21 expand to their natural shape (the shape shown in Figures 23A-23B) as they are released from the delivery sheath 46, while the intermediate portion 42 (second component) provides a cross-sectional area that can be enlarged and reduced in vivo in a manner further described below. For clarity, note that the device 28 is depicted as disproportionately large relative to the heart 22 in Figure 23A. The proximal and distal portions 40, 44 of device 21 can be “expanded” in that these portions extend radially outward at an acute angle from the axis of the intermediate portion of the stent. In some embodiments, as shown, each of the proximal and distal portion devices 40, 44 includes a plurality of leaves 25, such as six leaves 25 as shown. In other embodiments, the proximal and / or distal portions do not include a plurality of leaves and are rather shaped to define an expanded ring or have some other preferred form.

[0203] In some embodiments, to facilitate the removal of the device 21 from the object, in a manner as further described below with reference to Figures 23C-23E, several embodiments include one or more device-crushing flexible longitudinal elements 36 extending from the proximal portion 44 to the outside of the object. For example, as shown in Figures 23A-23B, the device-crushing flexible longitudinal elements may include a control wire 36. In some embodiments, while inside the object, the wire 36 is contained within a control wire lumen 37 of a delivery catheter 31, passing between the proximal portion 44 and the outside of the object. For example, the delivery catheter 31 may exit the object via the femoral vein of the object. As shown in Figure 23A, the proximal end of the control wire 36 may be coupled to a control handle 34, through which the wire 36 may be pulled (or, alternatively, released to allow the proximal portion of the device to expand). The wire 36 may remain coupled to the device 21 throughout the entire time the device is in a fixed position inside the object. Because the wire 36 remains coupled to the device 21, the device can be easily removed at any desired time (e.g., immediately) upon receiving an indication that the shunt is no longer required through the device, for example, in a manner described with reference to Figures 23C-23E. Figure 23B shows a particular embodiment in which the proximal portion 44 is shaped to define a plurality of orifices 48, and each of the control wires 36 passes through at least two of the orifices 48. For example, as shown, the ends of each leaf 25 may be shaped to define an orifice 48, and each wire may pass through the respective orifices of two adjacent leaves so that the wire passes through the orifice (thus, in the illustrated embodiment, the device having six proximal leaves is coupled to three wires 36, and each wire independently controls the crushing of each pair of adjacent leaves). The two proximal ends of each wire may be pulled to crush the proximal portion of the device 21.

[0204] Alternatively, in the embodiments shown, the single wire 36 may form a loop passing through the entire orifice 48, and this single wire controls the crushing of the entire proximal portion 44. In other words, the entire proximal portion can be crushed by pulling the two ends of this single wire. In yet another embodiment, the wire 36 does not form a loop, but rather a separate wire is coupled to each leaf. For example, each leaf may be coupled to the distal end of its respective wire. Thus, for example, a device having six proximal leaves would be coupled to six wires, one wire per leaf. Similarly, the wire 36 may be formed as an extension of a leaf such that each leaf has a wire extension that extends outside the object. In such embodiments, the proximal portion of the device may be crushed by pulling each single proximal end of the wire.

[0205] In some cases, it may be beneficial to increase or decrease the cross-sectional area of ​​the intermediate portion 42 while the device 21 is inside the target, for example, in a manner as described elsewhere in this specification. To enable an increase in the cross-sectional area of ​​the intermediate portion 42, the delivery catheter 31 may include an enlarged central multipurpose lumen 39 through which an angioplasty balloon or other suitable balloon may be passed via a guidewire and inflated, in a manner as described elsewhere in this specification. To reduce the cross-sectional area of ​​the intermediate portion 42, a catheter with one or more holes may be used to inject high-temperature saline into the device 21, in a manner as described elsewhere in this specification, to heat the thermal intermediate portion 42. In some embodiments, a catheter with one or more holes is passed through the delivery catheter 31 via a guidewire. In other embodiments, a catheter with one or more holes is not passed through a guidewire but is introduced separately into the device 21 from the guidewire through the multipurpose lumen 39 of the delivery catheter 31. It should be understood that the balloon expansion and heating process may be repeated any number of times to increase or decrease the cross-sectional area of ​​the intermediate portion 42, for example, to provide a suitable flow rate through the device 21, or to reposition the device 21.

[0206] In some embodiments, adjustment of the cross-sectional area of ​​the intermediate portion 42 of device 21 is based on pressure monitoring. For example, a pressure sensor located on device 21 may be used to obtain an intra-atrial pressure measurement. A signal indicating such a pressure measurement may be transmitted outside the body via a conductor 38 (also referred to as a signal wire), graphically shown in Figure 23A. The cross-sectional area of ​​the intermediate portion 42 may be adjusted in response to such measurement.

[0207] Alternatively, or in addition, the cross-sectional area of ​​the intermediate portion 42 may be adjusted in response to hemodynamic monitoring by applying fluid imaging techniques such as pulsed wave (PW) or continuous wave (CW) Doppler echocardiography.

[0208] In some embodiments, to place the device 21 within the septum, the device is first placed inside a delivery sheath 46 that has been collapsed and percutaneously inserted into the target vascular system, such as through the target femoral vein, and then passed through the vascular system into the right atrium 30, for example, through the inferior vena cava (alternatively, the sheath 46 may pass through the jugular vein and superior vena cava into the right atrium). Subsequently, the distal end of the sheath is passed through the septum into the left atrium 32. Prior to passing the distal end of the sheath through the septum, a puncture element may be used to create an opening within the septum, and optionally, a dilator may be used to enlarge the opening so that the distal end of the sheath can easily pass through the septum. In some embodiments, the dilator is configured and used in a manner as described with reference to Figures 19A-20I. Once the sheath has crossed the septum, the dilator is removed and connected to the catheter 31. The device 21 is then compressed and positioned within the proximal end of the delivery sheath 46. The catheter 31 is used to push the device 21 through the delivery sheath until the distal expanding portion 40 of the device is pushed from the distal end of the sheath and expands to its deployed shape. The sheath 46 is then slowly withdrawn from the septum until the distal expanding portion of the device 21 engages with the left atrial side of the septum. Continued withdrawal of the sheath allows the septum to pull the device 21 out of the sheath until the proximal expanding portion 44 is released and expands to its deployed shape on the right atrial side of the septum, as shown in Figure 23A. The expanded distal and proximal expanding portions 40 and 44 thereby fix and retain the device 21 across the interatrial septum. The intermediate portion 42 (second component) may initially remain in its crimped or compressed configuration having a first cross-sectional area, and may be suitably expanded to a second cross-sectional area using a balloon, which is passed through the lumen 39 of the catheter 31 via a guidewire. The cross-sectional area of ​​the intermediate portion 42 may subsequently increase and decrease in vivo in a manner as described elsewhere herein.

[0209] Following the deployment of device 21, the sheath 46 and catheter 31 may remain within the target while device 21 is in place. For example, the sheath 46 and catheter 31 may remain within the target such that the distal end of the catheter is near the proximal portion of the device. The catheter may therefore be used to deliver drug therapy to the device site, a pressure sensor within the catheter may be used to monitor intraatrial pressure, a balloon may be introduced into device 21 to increase the cross-sectional area of ​​the intermediate portion 42, or a catheter with one or more holes may be introduced into device 21 to decrease the cross-sectional area of ​​the intermediate portion 42. As an example, Figure 23A shows a catheter 31 coupled to a control handle 34 so that the control handle 34 can be used to advance and withdraw the catheter through the sheath 46.

[0210] Device 21 helps alleviate excess atrial pressure by allowing blood to flow from the higher-pressure atrium to the lower-pressure atrium using a flow rate that can be increased or decreased based on the specific needs of the patient. Device 21 may therefore be used as a temporary acute treatment for any relevant condition (e.g., pulmonary hypertension or congestive heart failure) in which alleviation of excess pressure is beneficial, or to help prevent left ventricular expansion and remodeling following, for example, an acute myocardial attack. When Device 21 is used as an acute treatment, the subject remains hospitalized until the subject's physician determines that adequate treatment has been provided, at which point Device 21 is removed from the subject in a manner as described with reference to Figures 23C-23E, and the subject is discharged from the hospital, if necessary. In some embodiments, the device apparatus 28 includes one or more pressure sensors, for example, located on Device 21, on any of the longitudinal elements, or within the catheter 31. Such pressure sensors may be used to measure (e.g., continuously) the intracellular pressure of the right and / or left atrium of the subject to monitor the progress of treatment, determine whether and by how much the cross-sectional area of ​​the intermediate portion 42 should be adjusted, and determine when the device may be removed from the subject. For example, one pressure sensor may be located on the proximal portion 40 of the device 21 and another pressure sensor on the distal portion 44 of the device so that pressure in both the left and right atria is measured.

[0211] In another embodiment, device 21 is used as a temporary measurement device to determine the optimal size for a permanently implanted shunt that will subsequently be implanted. In this embodiment, the cross-sectional area of ​​the middle portion 42 of device 21 is adjusted while monitoring pressure and / or other physiological parameters, as described in the acute treatment embodiment described above. Once the optimal cross-sectional area is determined, device 21 is removed from the subject in a manner described with reference to Figures 23C-23E, and a permanent shunt of the indicated size is implanted.

[0212] Herein, we refer to Figures 23C–23E, which collectively illustrate techniques for removing device 21 from object 20 according to several embodiments provided herein. Note that many of the details shown in Figures 23C–23E are provided for illustrative purposes only, and many variations of the illustrated techniques are included within the scope of this disclosure.

[0213] In Figure 23C, the sheath 46 is advanced until its distal end approaches the proximal portion 44 of the device 21. Subsequently, the control wire 36, which is attached to the device 21, is pulled as indicated by the arrow 54 shown in Figure 23C, so that an inward radial force is applied to the proximal portion 44. The inward radial force causes the proximal portion 44 to collapse at least partially, as shown in Figure 23D. Following the collapse of the proximal portion of the device 21, as shown in Figure 23E, the sheath 46 is advanced distally across the device 21, while the catheter 31 is held in place, drawing the proximal portion of the device 21 into the distal end of the sheath (as it passes across the device 21, the sheath may pass at least partially through the interatrial septum). As the sheath 46 continues to pass through the device 21 from the position shown in Figure 23E, the catheter may be pulled proximal while the sheath is held in place, and the device 21 is further pulled into the sheath until the sheath crushes the distal portion 40 of the device 21 so that the device 21 is completely crushed within the sheath. Subsequently, the sheath containing the catheter 31 and the device 21 may be removed from the object.

[0214] In some embodiments, the sheath 46 is advanced while the proximal portion 44 is crushed so that the catheter passes through the device 21 until the distal end of the catheter crosses through the septum and reaches the distal portion of the device 21, as the proximal portion 44 continues to collapse (in such embodiments, the condition shown in Figure 23D cannot actually occur because the sheath 46 covers the proximal portion of the device 21 before the proximal portion 44 of the device 21 is completely collapsed). Then, as the pulling of the device 21 by the catheter 31 via the wire 36 continues while the sheath 46 remains held in place or is pushed forward, the distal end of the catheter exerts force on the distal portion 40 of the device 21 so that the distal portion of the device 21 collapses and the device 21 is drawn into the catheter. In such embodiments, the device 21 may be less likely to be pulled into the right atrium before collapsing into the sheath, due to the sheath advancing across the device 21 while the wire 36 is being pulled.

[0215] Figures 23C–23E show a non-limiting embodiment in which the catheter 31 extends through a stopper 52 contained inside the control handle 34, and a wire 36 passes through the stopper 52. As the wire is pulled, the stopper 52 prevents or restricts the catheter 31 from moving proximal so that the majority of the pulling force acts on the proximal portion 44 rather than the catheter 31. Although flexible, the catheter 31 prevents buckling so that the pulling force is effectively transmitted to the proximal portion 44. In some embodiments, two separate tubes extend through a single lumen or two separate lumen of the catheter 31, one of which holds the control wire 36 and the other of which holds the signal wire 38. In another embodiment, the control wire 36 and the signal wire 38 extend through separate individual lumen, which are located within the wall of the catheter 31 when present, leaving an expanding central multipurpose lumen 39, as shown in Figure 23A. Such a tube may provide additional resistance to buckling so that the tensile force applied on the wire is effectively transmitted to the device 21. In such embodiments, the stopper 52 may be used to prevent or stop the tube holding the wire from moving proximal as the wire is pulled.

[0216] In some embodiments, the proximal portion 44 may be provided to a malleable shape-memory phase at body temperature, heat-set to a collapsed configuration similar to that shown in Figure 23D, and unfolded in a manner similar to those described with reference to Figures 23A-23B. However, instead of self-expansion, the proximal portion 44 may be unfolded by positioning an hourglass-shaped balloon through the device 21, inflating the balloon, and expanding the proximal portion. Such balloon expansion of the proximal portion 44 may be performed after the self-expansion of the distal portion 40.

[0217] It should be noted that apparatuses and methods as described with reference to Figures 23A-23E may also be used for applications in which device 21 will be permanently implanted. In such applications, during the implantation procedure, wire 36 may be used to facilitate the retrieval or repositioning of device 21 if the device is not properly positioned. Subsequently, upon confirmation that device 21 is properly installed, wire 36 may be detached from device 21 and removed from the object.

[0218] Other methods for suitably deploying and / or retrieving the device may be used. For example, Figures 32A–32G schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo, and embodiments of its use in the human body. In a manner such as that shown in Figure 32A and described elsewhere herein, the device 3300 may be positioned within an opening through the fovea ovalis. Device 3300 may correspond to, for example, device 200 as described with reference to Figures 2A-2E, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800, 2800', and 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The device 3300 may be formed primarily or substantially entirely from a shape-memory (martensite) material that is pre-set into its collapsed configuration. The device 3300 may be deployed by balloon expansion.

[0219] As illustrated in Figure 32A, the retrieval procedure for device 3300 may include positioning a guidewire through device 3300. In a manner as illustrated in Figure 32B, a designated retrieval catheter 3320 may cross over the wire 3310 and through device 3300 so that the distal end 3323 of catheter 3320 is positioned in the left atrium. The tip 3321 may be partially positioned within catheter 3320. For example, a portion of the tip 3321 may extend beyond the distal end 3323 of catheter 3320, and the outer surface of the tip 3321 may provide a relatively smooth profile to facilitate the guidance of the distal end 3323 with substantially no tissue damage. The cup 3322 may be fully positioned within catheter 3320. The tip 3321 and cup 3322 may be movable independently of each other and independently of catheter 3320. For example, tip 3321 may be coupled to shaft 3331, which includes a lumen through which guidewire 3310 passes. Shaft 3331 may extend or retract from the outside of the body relative to guidewire 3310, catheter 3320, and cup 3322, such that the entire tip 3321 extends beyond the past distal end 3323. Cup 3322 may be coupled to shaft 3332, which includes a lumen through which shaft 3331 (having guidewire 3310 within it) passes. Shaft 3332 may extend or retract from the outside of the body relative to guidewire 3310, catheter 3320, and tip 3321, such that at least a portion of cup 3322 extends beyond the distal end 3323. Tip 3321 and cup 3322 may each include a substantially rounded conical or bowl-shaped structure, which may include any preferred material, such as a superelastic material. The tip 3321 and the cup 3322 may each receive a portion of the device 3300 when the device 3300 is in a collapsed configuration, and may cooperate to substantially surround the device 3300 for retrieval and pull the device 3300 at least partially into the catheter 3320.

[0220] For example, in a configuration as illustrated in Figure 32C, after the distal end 3323 and tip 3321 of the catheter 3320 are positioned in the left atrium (LA), the shaft 3331 may be held in place to keep the tip 3321 in place, while the retrieval catheter 3320 and shaft 3322 are retracted such that the distal end 3323 and cup 3322 are retracted into the right atrium (RA), leaving a space between the tip 3321 and cup 3322 that coincides with the position of the device 3300. Optionally, at least a portion of the cup 3322 may extend beyond the distal end 3323, for example, by retracting the catheter 3320 relative to the shaft 3332, or by extending the shaft 3332 relative to the catheter 3320. In embodiments in which the cup 3322 includes a shape memory material, the cup 3322 may jump out at least partially to provide an increased volume for retrieving the device 3300. Furthermore, as shown in Figure 32C, the shaft 3331 may heat the device 3300 in a manner described elsewhere herein, for example, through which high-temperature saline solution 3324 can be injected toward the device 3300, causing the device 3300 to shrink to its heat-set (shrinked, e.g., substantially cylindrical) configuration as shown in Figure 32D. The tip 3321 may then be retracted by retracting the shaft 3331 relative to the shaft 3332 and the catheter 3320, for example, in a manner shown in Figure 32E, so as to draw the shrinked device 3300 into the rounded conical or bowl-shaped structure of the tip 3321. The tip 3321 may then be further retracted by further retracting the shaft 3331 relative to the shaft 3332 and catheter 3320, for example, in a manner illustrated in Figure 32F, thereby drawing the retracted device 3300 into the rounded conical or bowl-shaped structure of the cup 3322, and thus enclosing the retracted device 3300, at least partially.The cup 3322 and tip 3321 may then be retracted together, for example, by retracting both shafts 3331 and 3332 relative to the catheter 3320, so that the device 3300 is positioned within the catheter 3200, at least partially. For example, as shown in Figure 32F, a portion of the tip 3321 may extend beyond the distal end 3323 of the catheter 3320 in a manner similar to that described with reference to Figure 32B, and the cup 3322 may be positioned entirely within the catheter 3320 and a portion of the device, while a portion of the device 3300 may be within the catheter 3320, with a portion of the device 3300 extending beyond the distal end 3323. In a manner as illustrated in Figure 32G, the retrieval catheter 3320, tip 3321, cup 3322, and device 3300 may be retrieved by retracting both the catheter 3320, shaft 3331, and shaft 3332. The guidewire 3310 may be completely retrieved, and the septal opening may be closed with a closure device as known in the art. Further embodiments may also be conceived based on the teachings herein. For example, Figures 28A–28D schematically illustrate another exemplary device with internal dimensions that can be reduced and increased in vivo. The device 2800 illustrated in Figure 28A includes a braided shunt having a substantially cylindrical configuration and which may be formed using wires, as described above with reference to Figures 27A–27K. For example, the wire portions forming the outer portions 2811, 2812 of device 2800, which may extend into each atrium of the heart, may have an austenite phase (Af below body temperature, e.g., in the range of about 5 to 20°C), corresponding to regions A and C in Figure 28B, while the wire portions forming the inner portion 2813 of device 2800, which may be inserted into the interatrial septum, may have a martensite phase (Af above body temperature, e.g., in the range of about 50°C), corresponding to region B in Figure 28B. Regions A, B, and C in Figure 28B may be obtained by heat-treating preferred portions of the wire that are braided together in a manner similar to those described above with reference to Figures 27A to 27K to form device 2800.Device 2800 may also include a crimping / holding mechanism 2850 for use when delivering the device into the human body. As shown in the cross-section in Figure 28B, device 2800 may include a nitinol wire mesh tube, section B being heat-treated differently from sections A and C, such that the exemplary Af temperature shown in the figure is obtained. The ends of the tube may then be abducted and pulled backward across the central section B in a manner similar to turning a sock inside out, until the ends of sections A and C abut and are crimped together along the crimping section 2850, as shown in the cross-section in Figure 28A. Note that the crimping section 2850 may be off-center because section A is shorter than section C. The final result is a double-walled cylindrical shunt, in which the outer wall (in contact with the opening in the septum) has a low Af and is superelastic at body temperature, while the inner wall (forming an orifice for blood flow) has an Af higher than body temperature and is therefore in a malleable martensite phase at body temperature. In some embodiments, the martensite mesh extends completely through the center of the shunt and at least partway around each end. The device may have a fixed outer diameter set by the heat-set size of the superelastic outer wall, while the inner diameter may be increased by balloon expansion. If it is desired to reduce the inner diameter to its heat-set configuration after expansion, heat may be applied by injecting high-temperature saline, for example, in a manner described anywhere in this specification.

[0221] Figures 29A–29D schematically illustrate embodiments of the use of the devices shown in Figures 28A–28B within the human body. For example, the device 2800 may be delivered across the atrial septum in a manner as described elsewhere in this specification. As shown in Figure 29A, the device 2800 may have an initial heat-set inner diameter of, for example, about 4 mm when positioned across the atrial septum, and an initial outer diameter of, for example, about 7 mm. As shown in Figure 29B, a balloon 2900 may be positioned through the device 2800 and expanded to expand the inner diameter of the device to, for example, about 5–7 mm, while the outer diameter of the device remains substantially unaffected. As shown in Figure 29C, a heat source 2910, for example, a tube supplying a flow of heated saline solution, may cause the inner diameter of the device 2800 to contract to its initial heat-set inner diameter, as shown in Figure 29D.

[0222] Figure 28C illustrates an alternative device 2800', which is configured similarly to device 2800 but also includes a groove 2860 sized to engage with an opening through the atrial septum. Figures 30A–30C schematically illustrate embodiments of the use of the device of Figure 28C in the human body. As shown in Figure 30A, the alternative device 2800' may have an initial heat-set inner diameter of, for example, about 4 mm when positioned across the atrial septum, and an initial outer diameter of, for example, about 7 mm, while the groove 2860 engages with an opening through the atrial septum. In a manner similar to that described with reference to Figure 29B, a balloon is positioned through device 2800', and in a manner as illustrated in Figure 30B, the inner diameter of the device may be expanded to, for example, about 5–7 mm, while the outer diameter of the device remains substantially unaffected. In a manner similar to that described with reference to Figure 29C, a heat source, such as a tube supplying a flow of heated saline solution, may shrink the inner diameter of device 2800' to its initial heat-set inner diameter, as shown in Figure 30C. Figure 28D illustrates another exemplary alternative device 2800'', which is configured similarly to device 2800' but is also diabolo-shaped, including expanded ends 2811', 2812' extending into each atrium of the heart and a neck portion 2813' engaging with an opening through the atrial septum. Device 2800'' may be formed from braided heat-treated wire in a manner similar to that described with reference to Figures 27A-27K, and may be unfolded, with its inner dimensions being expanded and contracted, as described anywhere in this specification.

[0223] Therefore, what is provided herein is an interatrial shunt for placement in the atrial septum of a patient's heart. The interatrial shunt may be configured similarly to one or more of the following devices: device 200 as described with reference to Figures 2A–2E, device 700 as described with reference to Figures 7, 8A–8D, 9A–9B, and 10A–10C, device 1110 as described with reference to Figures 11A–11B, device 1210 as described with reference to Figures 12A–12B, device 1300 as described with reference to Figures 13A–13B, device 28 as described with reference to Figures 23A–23E, device 2500 as described with reference to Figures 25A–25D, device 2600 as described with reference to Figures 26A–26H, device 2700 as described with reference to Figures 27A–27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A–28D, 29A–29D, and 30A–30C. For example, an interatrial shunt may include a body that includes first and second regions coupled to fluidly communicate by a neck region, such as, for example, device 200 as described with reference to Figures 2A-2E, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The main body may include a shape memory material in a manner such as that described elsewhere in this specification.The main body may define a passage through a neck region for blood to flow between the first and second atria, in the form of, for example, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, or device 28 as described with reference to Figures 23A-23E. The first and second regions may be superelastic at body temperature, for example, in the form described anywhere in this specification, and the neck region may be malleable at body temperature. The flow area of ​​the passage through the neck region may be regulated in vivo, for example, in the form described anywhere in this specification.

[0224] The first and second superelastic regions may contain nitinol having an austenite termination temperature (Af) of 5 to 20°C, for example, in a manner described elsewhere in this specification. The malleable neck region may contain nitinol having an austenite termination temperature (Af) of 45 to 60°C, for example, in a manner described elsewhere in this specification. The neck region may be mechanically expandable, for example, in a manner described elsewhere in this specification. The neck region may be thermally shrinkable, for example, in a manner described elsewhere in this specification.

[0225] Furthermore, provided herein is an interatrial shunt for placement in the atrial septum of a patient's heart, for which the fluid flow through it can be regulated. The interatrial shunt may be configured similarly to one or more of the following devices: device 200 as described with reference to Figures 2A–2E, device 700 as described with reference to Figures 7, 8A–8D, 9A–9B, and 10A–10C, device 1110 as described with reference to Figures 11A–11B, device 1210 as described with reference to Figures 12A–12B, device 1300 as described with reference to Figures 13A–13B, device 28 as described with reference to Figures 23A–23E, device 2500 as described with reference to Figures 25A–25D, device 2600 as described with reference to Figures 26A–26H, device 2700 as described with reference to Figures 27A–27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A–28D, 29A–29D, and 30A–30C. For example, an interatrial shunt is described with reference to, for example, device 700 as shown in Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as shown in Figures 11A-11B, device 1210 as shown in Figures 12A-12B, device 1300 as shown in Figures 13A-13B, device 28 as shown in Figures 23A-23E, device 2500 as shown in Figures 25A-25D, and Figures 26A-26H. The device may include a first expandable end region configured to be installed in the first atrium of the heart, and a second expandable end region configured to be installed in the second atrium of the heart, as included in any of the devices 2600 described with reference to Figures 27A-27K, 2700 described with reference to Figures 28A-28D, 29A-29D, and 30A-30C, such as the devices 2800, 2800', and 2800'' described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The first and second expandable end regions may include a self-expanding superelastic material in a manner such as that described elsewhere herein.The interatrial shunt may include a neck region between the first and second expandable end regions, for example, contained within any of the following: device 200 as described with reference to Figures 2A-2E, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The neck region may be configured for placement in the atrial septum in any of the following forms: device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C; device 1110 as described with reference to Figures 11A-11B; device 1210 as described with reference to Figures 12A-12B; device 1300 as described with reference to Figures 13A-13B; device 28 as described with reference to Figures 23A-23E; device 2500 as described with reference to Figures 25A-25D; device 2600 as described with reference to Figures 26A-26H; device 2700 as described with reference to Figures 27A-27K; or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The neck region may include a malleable shape memory material in any form as described elsewhere in this specification.An interatrial shunt may define a passage through a neck region for blood to flow between the first and second atria, in the form of, for example, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or any of devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The neck region may be heat-treated to exhibit different shape memory properties from the first and second expandable end regions, for example, in a manner described in any part of this specification, for example, in a manner described with reference to Figures 10A-10C, 27A-27K, 29A-29D, or 30A-30C, so that the cross-sectional area of ​​the passage can be adjusted in vivo.

[0226] The malleable shape memory material may be configured to expand in vivo, for example, in a manner described anywhere in this specification, such that the passage expands from a cross-sectional area to a second cross-sectional area larger than the first cross-sectional area. The malleable shape memory material may also be configured to contract in vivo, for example, in a manner described anywhere in this specification, such that the passage contracts from a second cross-sectional area to a third cross-sectional area smaller than the second cross-sectional area. The cross-sectional area is 4.9 to 28.3 mm². 2 It may also be the case that the second and third cross-sectional areas are 15.9 to 78.6 mm². 2It may be. For example, for any of the devices 200 described with reference to FIGS. 2A to 2E, the device 700 described with reference to FIGS. 7, 8A to 8D, 9A to 9B, and 10A to 10C, the device 1110 described with reference to FIGS. 11A to 11B, the device 1210 described with reference to FIGS. 12A to 12B, the device 1300 described with reference to FIGS. 13A to 13B, the device 28 described with reference to FIGS. 23A to 23E, the device 2500 described with reference to FIGS. 25A to 25D, the device 2600 described with reference to FIGS. 26A to 26H, the device 2700 described with reference to FIGS. 27A to 27K, or the devices 2800, 2800', 2800'' described with reference to FIGS. 28A to 28D, 29A to 29D, and 30A to 30C, the cross-sectional area may be 4.9 to 28.3 mm 2 It may be, and the second cross-sectional area and the third cross-sectional area may be 15.9 to 78.6 mm 2 It may be.

[0227] The malleable shape memory material may contain nitinol having an austenite termination temperature (Af) of 45 to 60°C, for example, in a manner described elsewhere in this specification. The self-expanding superelastic material may contain nitinol having an austenite termination temperature (Af) of 5 to 20°C, for example, in a manner described elsewhere in this specification. The malleable shape memory material may be mechanically expandable, for example, in a manner described elsewhere in this specification. The malleable shape memory material may be thermally shrinkable, for example, in a manner described elsewhere in this specification. The cross-sectional area of ​​the neck portion may be smaller than at least one individual cross-sectional area of ​​the first and second expandable end regions, in a manner such as that described with respect to device 200 as described with reference to Figures 2A-2E, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800', 2800'' as described with reference to Figures 28C-28D and 30A-30C.The first and second expandable end regions are, for example, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, and device 2500 as described with reference to Figures 25A-25D. In any form such as device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C, the respective ends of the first and second expandable end regions may extend into the first and second atria such that they do not come into contact with the atrial septum.

[0228] The first and second expandable end regions, as well as the neck region, may constitute a diabolo-shaped shunt in the form of, for example, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or device 2800'' as described with reference to Figure 28D. The neck region may include structural members such as a cylindrical shunt in the form of device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, a compression coil in the form of device 2500 as described with reference to Figures 25A-25D, or a compression spring in the form of device 2600 as described with reference to Figures 26A-26H. The structural members (e.g., cylindrical shunt, compression coil, or compression spring) may be located outside the diabolo-shaped shunt in the form of device 1110 as described with reference to Figures 11A-11B, device 2500 as described with reference to Figures 25A-25D, or device 2600 as described with reference to Figures 26A-26H. The structural members (e.g., cylindrical shunts, compression coils, or compression springs) may be formed from a malleable shape memory material such that the structural members (e.g., cylindrical shunts, compression coils, or compression springs) constrain the dimensions of a diabolo-shaped shunt radially in the neck region, for example, in the device 1110 as described with reference to Figures 11A-11B, the device 2500 as described with reference to Figures 25A-25D, or the device 2600 as described with reference to Figures 26A-26H, and the diabolo-shaped shunt may self-expand in the neck region in response to the malleable shape memory material expanding to a second cross-sectional area.The cylindrical shunt may be located inside the diabolo-shaped shunt, for example, in the form of device 1210 as described with reference to Figures 12A-12B, or device 1300 as described with reference to Figures 13A-13B. The cylindrical shunt does not have to be directly coupled to the diabolo-shaped shunt and neck region, for example, in the form of device 1210 as described with reference to Figures 12A-12B, or device 1300 as described with reference to Figures 13A-13B. The device may further include a covering material that indirectly and elastically connects the cylindrical shunt to the diabolo-shaped shunt, for example, in the form of device 1210 as described with reference to Figures 12A-12B. The contraction of the cylindrical shunt does not have to cause contraction of the diabolo-shaped shunt in the neck region, for example, in the form of device 1210 as described with reference to Figures 12A-12B, or device 1300 as described with reference to Figures 13A-13B. Diabolo-shaped and cylindrical shunts may be integrally formed from a common frame, for example, in a manner described elsewhere in this specification. The first and second expandable end regions, and the neck region, may be integrally formed from a common frame, for example, in a manner described elsewhere in this specification. The first and second expandable end regions, and the neck region, may be encased in at least partially biocompatible material, for example, in a manner described elsewhere in this specification.

[0229] Also provided herein is an interatrial shunt for regulating the fluid flow within a heart having a first atrium, a second atrium, and an interatrial septum. The interatrial shunt may be configured similarly to one or more of the following devices: device 200 as described with reference to Figures 2A-2E, device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C, device 1110 as described with reference to Figures 11A-11B, device 1210 as described with reference to Figures 12A-12B, device 1300 as described with reference to Figures 13A-13B, device 28 as described with reference to Figures 23A-23E, device 2500 as described with reference to Figures 25A-25D, or device 2600 as described with reference to Figures 26A-26H, device 2700 as described with reference to Figures 27A-27K, or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. For example, the interatrial shunt may include a first region configured to be placed in a first atrium, comprising a self-expanding superelastic material, such as that contained in any of the following: device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C; device 1110 as described with reference to Figures 11A-11B; device 1210 as described with reference to Figures 12A-12B; device 1300 as described with reference to Figures 13A-13B; device 28 as described with reference to Figures 23A-23E; device 2500 as described with reference to Figures 25A-25D; device 2600 as described with reference to Figures 26A-26H; device 2700 as described with reference to Figures 27A-27K; or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The first region may be superelastic at body temperature in a manner such as that described elsewhere herein.Interatrial shunts are described, for example, with reference to devices 700 (described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C), 1110 (described with reference to Figures 11A-11B), 1210 (described with reference to Figures 12A-12B), 1300 (described with reference to Figures 13A-13B), 28 (described with reference to Figures 23A-23E), 2500 (described with reference to Figures 25A-25D), and 26A-26H. The device may include a second region comprising a malleable shape memory material, configured to be installed through an opening in the atrial septum to provide fluid flow from the first atrium to the second atrium, as included in any of the devices 2600 described herein, 2700 described with reference to Figures 27A-27K, or 2800, 2800', 2800'' described with reference to Figures 28A-28D, 29A-29D, and 30A-30C. The second region may be malleable at body temperature, for example, in a manner described anywhere in this specification. The malleable shape memory material may have a first cross-sectional area, for example, in a manner described anywhere in this specification. The malleable shape memory material may be expandable from the first cross-sectional area to the second cross-sectional area, for example, in a manner described anywhere in this specification. The malleable shape memory material may be shrinkable from a second cross-sectional area to a third cross-sectional area, for example, in a manner described anywhere in this specification.

[0230] The self-expanding superelastic material may contain nitinol having an austenite termination temperature (Af) of 5 to 20°C, for example, in a manner described elsewhere herein, and the malleable shape memory material may contain nitinol having an austenite termination temperature (Af) of 45 to 60°C. The malleable shape memory material may be mechanically expandable and thermally contractible, for example, in a manner described elsewhere herein. The interatrial shunt may include, for example, a second self-expanding superelastic material, as contained in any of the following: device 700 as described with reference to Figures 7, 8A-8D, 9A-9B, and 10A-10C; device 1110 as described with reference to Figures 11A-11B; device 1210 as described with reference to Figures 12A-12B; device 1300 as described with reference to Figures 13A-13B; device 28 as described with reference to Figures 23A-23E; device 2500 as described with reference to Figures 25A-25D; device 2600 as described with reference to Figures 26A-26H; device 2700 as described with reference to Figures 27A-27K; or devices 2800, 2800', 2800'' as described with reference to Figures 28A-28D, 29A-29D, and 30A-30C; and may include a third region configured to be placed in a second atrium and coupled to a second region.

[0231] It should be understood that in any of these embodiments, the device configuration may be reversibly modified in vivo. In many embodiments, the configuration change involves increasing or decreasing the dimensions of the device, such as the internal or external dimensions of the device. However, other configuration changes may also be suitably implemented. For example, Figures 31A–31E schematically illustrate exemplary devices with configurations that can be reversibly modified in vivo. Device 3100, illustrated in Figures 31A–31E, may be configured in some respects similarly to that described in Shanley's U.S. Patent No. 6,964,680, entitled “Expandable medical device with tapered hinge” (the entire contents of which are incorporated herein by reference). Figures 31A–31B show plan views of representative portions of the unexpanded tissue-supported medical device 3100, while Figures 31C–31E are detail views of the expandable medical device of Figures 31A–31B undergoing sequential expansion.

[0232] In a manner similar to that described in U.S. Patent No. 6,964,680, the device 3100, as illustrated in Figures 31A-31B, may include a series of axial slots 3210 formed within a cylindrical tube (not shown). Each axial slot 3210 may be radially displaced by about 0.010 inches from a slot in an adjacent row of slots. Multiple axial slots 3210 may define multiple extension beams 3220. Multiple extension beams 3220 may be interconnected by hinges 3250 located at one end and locking areas located at the other end. U-shaped links 3270 may interconnect adjacent rows of beams 3220. The extension beams 3220 may further include a claw 3230 having a distal end 3235 located at one end of the extension beam 3220, and multiple teeth 3240 located at the other end opposite the claw 3230. The distal end 3235 of the claw 3230 may be adjacent to the teeth 3240 of the adjacent extension member 3220. The extension beam 3220 may further include a hinge 3250 adjacent to the claw 3230. The hinge 3250 may further include a first end 3252 and a second end 3254, and may define a section 3265, the section 3265 between the first end 3252 and the second end 3254, which may be designed to act as a stress / strain concentration area. Specifically, the hinge 3250 may include a first section extending along about one-third of the length of the hinge 3250, and a second section that is gradually tapered and extends along about two-thirds of the length of the hinge 3250. Other ratios and geometric shapes may also be considered to be used to constrain the maximum stress / strain to hinge section 3265. Furthermore, the length and width of the hinge can be adjusted to constrain the maximum strain within hinge 3250 to a desired value at the maximum required bending radius of hinge 3250. For example, if the maximum desired bending angle of hinge 3250 is set to 90 degrees and the minimum hinge width is fixed to approximately 0.002 inches, a hinge length can be determined such that the maximum strain within hinge 3250 is well below the elastic limit of the hinge material.

[0233] Referring here to Figures 31C-31E, a plan view of the cross-section of the expandable medical device 3100 as it is unfolded is shown. In a manner similar to that described in U.S. Patent No. 6,964,680, the expandable device 3100 may be expanded radially by placing a suitable device, such as a balloon catheter, within the inner diameter of the expandable device 3100 and expanding the balloon catheter until the expandable device is expanded to a desired diameter. A partial section of the expandable device 3100 is shown as shown in Figure 31C. As will be described in detail with reference to Figures 31A-31B, the expandable device 3100 may include a plurality of extension members 3220 spaced apart by radial slots 3210. The extension members may have a claw 3230 positioned on one end, a plurality of teeth 3240 positioned on the other end, and a hinge 3250 adjacent to the claw 3230. Multiple extension members 3220 may be joined together by a hinge 3250 and a locking mechanism. In the non-extended state, as shown in Figure 31C, a claw 3230 located at one end of the extension member 3220 may be substantially parallel to the hinge 3250. Furthermore, the distal end 3235 of the claw 3230 may be designed to have a "chisel" shape adapted to be received by at least one of a plurality of teeth 3240 on an adjacent substantially parallel extension member 3220.

[0234] Referring here to Figure 31D, a partial cross-section of the expandable device 3100 is shown, which is expanded to a second partially expanded diameter. As indicated by arrow 3300, a general rotational motion may be achieved by the claw 3230 as the diameter of the expandable device 3100 increases and the hinge 3250 bends in a manner similar to that described in U.S. Patent No. 6,964,680. As shown, as it rotates, the trajectory of a point traced by the distal tip 3235 of the claw 3230 may describe a non-circular arc. The hinge 3250 may first bend about a predetermined point in region 3265, as shown in Figure 31D. The predetermined bending point may be determined by the narrowing width of the hinge 3250 in cross-section 3265, as defined by the first end 3252 and the second end 3254 of the hinge 3250. As shown in Figure 31D, as the claw rotates during the extension of the device from the unextended state shown in Figure 31A to the partially extended state shown in Figure 31D, the claw 3230 may no longer be substantially parallel to the hinge 3250 due to the bending of the hinge 3250.

[0235] Referring here to Figure 31E, a cross-section of the expandable medical device 3100 in its expanded state during the engagement of the locking mechanism is shown. As shown, a significant curvature occurs in the hinge 3250, specifically in the segment 3265. As this curvature occurs, the claw 3230 and its distal end 3235 become capable of both continued angular deflection, as indicated by arrow 3300, and linear motion along the axis of the claw 3230, as indicated by arrow 3320. Both angular motion 3300 and linear motion 3320 are possible in this region because the axis of the claw 3230 is no longer directly aligned with the currently curved centroid axis of the hinge 3250. Rather, the motion of the claw 3230 along its own axis requires only additional bending of the hinge 3250 near the second end 3254 of the hinge 3250. The ability of the hinge 3250 to provide both rotational motion 3300 and axial motion 3320 allows the distal tip 3235 of the claw 3230 to follow the contour of the teeth 3240 without local plastic yielding of either feature. In addition, the elastic energy stored within the hinge 3250 provides means (not shown) for generating a spring-returning force at the distal tip 3235 of the claw, which can be decomposed into components parallel and perpendicular to the axis of the claw. When the expansion device is positioned beyond one of the locking teeth 3240 at the distal tip 3235 of the claw 3230, and the expansion device is subsequently withdrawn, these spring-returning forces push the distal tip 3235 forward and into contact with the locking tooth 3240, in a manner described in U.S. Patent No. 6,964,680, thereby locking the expandable device 3100 in the expanded state. The occlusal surface of the distal tip 3235 and the locking tooth 3240 are contoured according to well-known techniques to ensure that forces applied externally to the tissue support device 3100 act to further lock the feature in place. Furthermore, the tooth 3240 may include many different geometric shapes, which are adapted to receive the distal end 3235 of the claw 3230. For example, the tooth 3240 may include a recess adapted to receive the distal end 3235 of the claw 3230. Thus, the tooth 3240 as shown and described should not be considered limiting, but merely illustrative.It is considered that the distal ends 3235 of the teeth 3240 and claws 3230 may include many different shapes that would be obvious to those skilled in the art.

[0236] In addition, in a manner as described in U.S. Patent No. 6,964,680, the hinge 3250 may be contoured as described above to control the bending pattern of the hinge 3250, and thus the movement of the claw during the bending sequence. For example, when the width of the hinge is narrowest near the proximal end 3232 of the claw 3230, the hinge may tend to bend first in this area. As a result, the instantaneous center of rotation of the claw may first be closer to the proximal end 3232 of the claw 3230, and the arc traced by the distal tip 3235 of the claw 3230 may rapidly pass through region 3238, as shown in Figures 31C-31E. This can be visualized by imagining the limit case of a simple pivot point located at the end 3252 of the hinge 3250, in which the arc traced by the distal tip 3235 would be circular, and the initial motion of the tip 3235 would be perpendicular to the axis of the claw 3230 (i.e., downward, or directly toward the adjacent strut 3220). The second limit case would correspond to a pivot point at the other end 3254 of the hinge 3250. The arc traced by the distal tip 3235 would again be circular, but in this case the initial motion of the tip 3235 would be parallel to the axis of the claw 3230, and the tip of the claw would move from the outset away from contact with the adjacent strut 3220, making engagement with the teeth 3240 of the adjacent strut 3220 impossible. By shaping the hinge 3250 between these extremes, the relative motion of the pawl 3230 with respect to the adjacent support column 3220, which contains the teeth 3240, may be optimized.

[0237] U.S. Patent No. 6,964,680 discloses the use of certain materials within device 3100, and this disclosure provides that any preferred combination of superelastic and shape-memory nitinol components may be used within device 3100. For example, the ductile hinge 3250 may be formed from nitinol that is in the martensite phase at body temperature, while the remainder of device 3100 may be superelastic. As described above, it is conceivable to manufacture device 3100 by laser cutting from a single tube of superelastic nitinol, followed by localized heat treatment of the ductile hinge 3250 using multiple high-intensity laser pulses, raising Af above body temperature or to about 50°C, so that device 3100 can perform in the manner described with reference to Figures 31C-31E and, when heated (for example, using high-temperature saline, in the manner described anywhere in this specification), can return to a pre-set configuration so that the locking mechanism is released. For e...

Claims

1. An interatrial shunt for placement in the atrial septum of the patient's heart, The interatrial shunt comprises a body having first and second regions connected by a neck region to be in fluid communication, the body comprising a shape memory material comprising nitinol, defining a passage through the neck region for blood to flow between the first and second atria, and the neck region being heat-treated to exhibit different shape memory properties from the first and second regions. The first and second regions are superelastic at body temperature. The neck region is malleable at body temperature, and the neck region comprises nitinol having an austenite termination temperature (Af) of 45 to 60°C. The flow area of ​​the passage through the aforementioned neck region can be regulated within the body. Interatrial shunt.

2. The interatrial shunt according to claim 1, wherein the first and second superelastic regions comprise nitinol having an austenite termination temperature (Af) of 5 to 20°C.

3. The interatrial shunt according to claim 1 or 2, wherein the neck region is mechanically expandable.

4. The aforementioned neck region is thermally transitionable, as described in any one of claims 1 to 3, for the interatrial shunt.

5. The neck portion region is mechanically expandable and thermally transitionable, The neck region is configured to expand within the body such that the passage expands from a first cross-sectional area to a second cross-sectional area larger than the first cross-sectional area. The neck region is configured to contract within the body such that the passage contracts from the second cross-sectional area to a third cross-sectional area smaller than the second cross-sectional area, and The first cross-sectional area is 4.9 to 28.3 mm². ２ The second and third cross-sectional areas are 15.9 to 78.6 mm². ２ The interatrial shunt according to claim 1 or claim 2.

6. An interatrial shunt for placement in the atrial septum of a patient's heart, wherein the interatrial shunt is configured to allow for adjustable control of fluid flow through it, A first expandable end region configured to be installed within the first atrium of the heart, A second expandable end region configured to be installed within the second atrium of the heart, wherein the first and second expandable end regions comprise a self-expanding superelastic material, A neck region between the first and second expandable end regions, configured for placement in the atrial septum, the neck region comprises a malleable shape memory material comprising nitinol having an austenite termination temperature (Af) of 45 to 60°C, and the interatrial shunt defines a passage through the neck region for blood to flow between the first atrium and the second atrium. An interatrial shunt comprising, wherein the neck region is heat-treated to exhibit different shape-memory properties from the first and second expandable end regions, so that the cross-sectional area of ​​the passage can be adjusted in vivo.

7. The interatrial shunt according to claim 6, wherein the malleable shape memory material is mechanically expandable and is configured to expand in vivo such that the passage expands from the cross-sectional area to a second cross-sectional area larger than the cross-sectional area.

8. The interatrial shunt according to claim 7, wherein the malleable shape memory material is thermally transitionable and is configured to be contracted in vivo such that the passage contracts from a second cross-sectional area to a third cross-sectional area smaller than the second cross-sectional area.

9. The aforementioned cross-sectional area is 4.9 to 28.3 mm². ２ The second and third cross-sectional areas are 15.9 to 78.6 mm². ２ The interatrial shunt according to claim 8.

10. The interatrial shunt according to any one of claims 6 to 9, wherein the self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of 5 to 20°C.

11. The interatrial shunt according to any one of claims 6 to 10, wherein the cross-sectional area of ​​the neck portion region is smaller than the cross-sectional area of ​​at least one individual of the first and second expandable end regions.

12. The interatrial shunt according to any one of claims 6 to 11, wherein the first and second expandable end regions extend into the first and second atria, respectively, such that the respective ends of the first and second expandable end regions do not come into contact with the atrial septum.

13. The interatrial shunt according to any one of claims 6 to 12, wherein the first and second expandable end regions and the neck region constitute a diabolo-shaped shunt.

14. The aforementioned neck region constitutes a cylindrical shunt, as described in claim 13.

15. The interatrial shunt according to claim 14, wherein the cylindrical shunt is located outside the diabolo-shaped shunt.

16. The interatrial shunt according to claim 15, wherein the cylindrical shunt is formed from the malleable shape memory material such that the cylindrical shunt constrains the dimensions of the diabolo-shaped shunt in the neck region in the radial direction, and the diabolo-shaped shunt self-expands in the neck region in response to the malleable shape memory material expanding to a second cross-sectional area.

17. The interatrial shunt according to claim 14, wherein the cylindrical shunt is located inside the diabolo-shaped shunt.

18. The interatrial shunt according to claim 14, wherein the cylindrical shunt is not directly connected to the diabolo-shaped shunt and the neck region, and further comprises an encapsulating material that indirectly and elastically connects the cylindrical shunt to the diabolo-shaped shunt.

19. The interatrial shunt according to claim 14, wherein the contraction of the cylindrical shunt does not cause the contraction of the diabolo-shaped shunt in the neck region.

20. The interatrial shunt according to claim 14, wherein the diabolo-shaped shunt and the cylindrical shunt are integrally formed from a common frame.

21. The interatrial shunt according to any one of claims 6 to 13, wherein the first and second expandable end regions and the neck region are integrally formed from a common frame.

22. The interatrial shunt according to any one of claims 6 to 13, wherein the first and second expandable end regions and the neck region are at least partially encased in a biocompatible material.

23. An interatrial shunt for regulating the fluid flow within a heart having a first atrium, a second atrium, and an interatrial septum, wherein the interatrial shunt is A first region comprising a self-expanding superelastic material containing nitinol, configured to be installed in the first atrium, wherein the first region is superelastic at body temperature, A second region comprising a malleable shape memory material, configured to be installed through an opening in the atrial septum to provide fluid flow from the first atrium to the second atrium, wherein the second region is heat-treated differently from the first region so that the second region is malleable at body temperature, and the second region comprises nitinol having an austenite termination temperature (Af) of 45 to 60°C. Equipped with, The aforementioned malleable shape memory material is mechanically expandable and thermally transitionable. The malleable shape memory material has a first cross-sectional area, The malleable shape memory material is expandable from the first cross-sectional area to the second cross-sectional area, The malleable shape memory material is shrinkable from the second cross-sectional area to the third cross-sectional area. Interatrial shunt.

24. The interatrial shunt according to claim 23, wherein the self-expanding superelastic material comprises nitinol having an austenite termination temperature (Af) of 5 to 20°C.

25. The interatrial shunt according to claim 23 or 24, further comprising a third region comprising a second self-expanding superelastic material, configured to be installed within the second atrium and coupled to the second region.

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