JP5031838B2 - 弁置換のためのステント−弁ならびに手術のための付随する方法およびシステム - Google Patents
弁置換のためのステント−弁ならびに手術のための付随する方法およびシステム Download PDFInfo
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- JP5031838B2 JP5031838B2 JP2009527033A JP2009527033A JP5031838B2 JP 5031838 B2 JP5031838 B2 JP 5031838B2 JP 2009527033 A JP2009527033 A JP 2009527033A JP 2009527033 A JP2009527033 A JP 2009527033A JP 5031838 B2 JP5031838 B2 JP 5031838B2
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- stent
- valve
- component
- attachment
- replacement valve
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0083—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using hook and loop-type fasteners
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0067—Three-dimensional shapes conical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/0078—Quadric-shaped hyperboloidal
-
- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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Description
本出願は、2006年9月7日に出願された米国仮特許出願番号第60/843,181号、および2006年12月21日に出願された米国特許出願番号第11/700,922号の利益を主張しており、これらの各々は、その全体が本明細書中に参考として援用される。
本発明の実施形態は、ステント−弁、ならびに最小侵襲的手術を介するそれらの送達のための付随する方法およびシステムに関する。
心臓弁置換の従来のアプローチは、外科医が患者の心臓にアクセスすることを可能にするために、患者の胸骨(胸骨切開術)または胸腔(開胸術)における比較的大きな開口部の切断を必要とする。さらに、これらアプローチは、患者の心臓の停止および心肺バイパスを必要とする(すなわち、患者の血液を酸素化し、そして循環するための心臓−肺バイパス機械の使用)。それらの侵襲性にもかかわらず、これらの外科的アプローチは、最初の介入として合理的に安全であり得る。しかし、この最初の手術から生じる組織接着は、引き続く弁置換手術に付随するリスク(例えば死亡)を増加し得る。非特許文献1;および非特許文献2を参照のこと;これら各々は、その全体が本明細書中に参考として援用される。
本発明のいくつかの実施形態は、心臓弁置換のためのシステム、方法、およびデバイスに関する。例えば、これらの方法、システム、およびデバイスは、不全の大動脈弁、僧帽弁、三尖弁、および肺動脈弁の置換を含む、心臓弁治療の全範囲に適用可能であり得る。いくつかの実施形態では、本発明は、外科的アプローチを容易にし得、それによって、手術が、開放−胸部腔および心臓−肺バイパスの必要なくして拍動する心臓に対して実施される。この最小侵襲的外科的アプローチは、まず第1に不全の生来の弁を置換することに付随するリスク、および不全の人工(例えば、生物学的または合成)弁を置換するための第2または引き続く手術に付随するリスクを減少し得る。
例えば、本発明は、以下の項目を提供する。
(項目1)ヒト身体内での使用のための置換弁であって:
弁構成要素;
第1の部分、該弁構成要素を収容する第2の部分、および第3の部分を備えるステント構成要素を備え、
ここで、該第3の部分が、送達デバイスへの離脱可能な取付けのための形態である少なくとも1つの取付け要素を備える、置換弁。
(項目2)前記少なくとも1つの取付け要素が、前記送達デバイスの相補的要素への離脱可能な取付けのための形態である幾何学的開口部を備える、項目1に記載の置換弁。
(項目3)前記少なくとも1つの取付け要素が、前記送達デバイスの相補的要素への離脱可能な取付けのための形態であるワイヤ、フックまたはストラップを備える、項目1に記載の置換弁。
(項目4)前記少なくとも1つの取付け要素が、少なくとも2つの取付け要素を備える、項目1に記載の置換弁。
(項目5)前記少なくとも1つの取付け要素が、少なくとも3つの取付け要素を備える、項目1に記載の置換弁。
(項目6)前記少なくとも1つの取付け要素が、少なくとも6つの取付け要素を備える、項目1に記載の置換弁。
(項目7)前記ステント構成要素が:
少なくとも1つの交連ポスト;および
前記少なくとも1つの取付け要素を備える格子構造体を備える、項目1に記載の置換弁。
(項目8)前記格子構造体がさらに、前記少なくとも1つの交連ポストを前記少なくとも1つの取付け要素に連結するための少なくとも1つの支持要素を備える、項目7に記載の置換弁。
(項目9)前記少なくとも1つの取付け要素が、前記ステント構成要素の中心軸に向かって少なくとも部分的に内方に突出する、項目1に記載の置換弁。
(項目10)前記第3の部分が、前記第2の部分の直径より小さい直径を有する、項目1に記載の置換弁。
(項目11)ヒト身体内での使用のための置換弁であって:
弁構成要素;および
固定要素を備える第1の部分;
該弁構成要素を収容するような形態である第2の部分;および
少なくとも1つの取付け要素を備える第3の部分を備えるステント構成要素を備える、置換弁。
(項目12)前記固定要素が、環状溝を備える、項目11に記載の置換弁。
(項目13)前記環状溝が複数の独立に屈曲可能な要素から形成され、ここで、各々の屈曲可能な要素が、その位置が取付られた対の支柱の長さによって決定される屈曲変形を備える、項目12に記載の置換弁。
(項目14)前記取付け要素が、開口部、フック、またはストラップを形成するワイヤを備える、項目11に記載の置換弁。
(項目15)前記第2の領域が、該第2の領域の外面から外方に突出する少なくとも1つのロック要素を備える、項目11に記載の置換弁。
(項目16)心臓ステント−弁送達システムであって:
外側シースおよびガイドワイヤ管材を備える第1のアセンブリ;および
ステント−弁の少なくとも1つの取付け要素への離脱可能な取付けのための形態であるステントホルダーを備える第2のアセンブリを備え、該ステント−弁が該第1のアセンブリのガイドワイヤ管材上に位置決めされ、
ここで、該第1のアセンブリと該第2のアセンブリとが、閉鎖位置から開放位置まで移行するような互いに対する相対的移動のための形態であり、該閉鎖位置では、該外側シースが、該ステントホルダーになお取り付られている該ステント−弁を取り囲み、そしてそれ故に該ステント−弁の拡大を拘束し、そして該開放位置では、該外側シースが、該ステント−弁の拡大を拘束せず、そしてそれ故に該ステント−弁が該ステントホルダーから離脱し、そして完全に拡大された形態まで拡大する、心臓ステント−弁送達システム。
(項目17)前記第1のアセンブリおよび前記第2のアセンブリが、前記閉鎖位置から、部分的開放位置まで、さらに前記開放位置まで移行するような形態であり、ここで、該部分的開放位置では、前記ステント−弁が部分的に近位方向に拡大するが、前記外側シースが該ステント−弁の少なくとも1つの取付け要素および該ステントホルダーをなお取り囲むので該ステントホルダーから離脱しない、項目16に記載の心臓ステント−弁送達システム。
(項目18)フラッシュ機構をさらに備える、項目17に記載の心臓ステント−弁送達システム。
(項目19)少なくとも1つのバルーンをさらに備え、該少なくとも1つのバルーンが、前記ステント−弁の移植および拡大の前、または該少なくとも1つのバルーンの膨張に基づく該ステント−弁の拡張の後に、少なくとも1つの弁形成術を引き起こすような形態である、項目16に記載の心臓ステント−弁送達システム。
(項目20)前記少なくとも1つのバルーンが、前記ステント−弁の近位方向に収容される、項目19に記載の心臓ステント−弁送達システム。
(項目21)前記少なくとも1つのバルーンが、前記ステント−弁の遠位方向に収容される、項目19に記載の心臓ステント−弁送達システム。
(項目22)前記少なくとも1つのバルーンが、前記ステント−弁の内に少なくとも部分的に収容される、項目19に記載の心臓ステント−弁送達システム。
(項目23)前記第1のアセンブリと前記第2のアセンブリとの相対的移動を引き起こすためのプッシュハンドルをさらに備える、項目16に記載の心臓ステント−弁送達システム。
(項目24)ハンドルの回転運動を、前記第1のアセンブリと前記第2のアセンブリとの相対的移動に変えるためのねじ機構をさらに備える、項目16に記載の心臓ステント−弁送達システム。
(項目25)前記ステント−弁の移植部位への送達の間に、前記第1のアセンブリおよび前記第2のアセンブリがその中に位置決めされる一体型導入具をさらに備え、ここで、該一体型導入具が、該第1のアセンブリおよび該第2のアセンブリが除去された後でさえ、患者身体内に残るような形態である、項目16に記載の心臓ステント−弁送達システム。
(項目26)前記ステント−弁の前記完全に拡大された形態への拡大の後に、前記送達システムが、前記第2のアセンブリを該ステント−弁を通って、前記第1のアセンブリの遠位端に向かって通過することによって前記閉鎖位置まで戻るような形態である、項目16に記載の心臓ステント−弁送達システム。
(項目27)前記ステント−弁の前記少なくとも1つの取付け要素が、前記ステントホルダーの相補的構造体への離脱可能な取付けのための形態である幾何学的開口部を備える、項目16に記載の心臓ステント−弁送達システム。
(項目28)前記幾何学的開口部が、円形または卵形の開口部を含む、項目27に記載の心臓ステント−弁送達システム。
(項目29)前記ステント−弁の前記少なくとも1つの取付け要素が、前記ステントホルダーの相補的構造体への離脱可能な取付けのための形態である、ワイヤ、フック、またはストラップを備える、項目16に記載の心臓ステント−弁送達システム。
(項目30)前記ステント−弁の前記少なくとも取付け要素が、前記ステントホルダーの対応する数の相補的構造体への離脱可能な取付けのための形態である少なくとも2つの取付け要素を備える、項目16に記載の心臓ステント−弁送達システム。
(項目31)前記ステント−弁の前記少なくとも取付け要素が、前記ステントホルダーの対応する数の相補的構造体への離脱可能な取付けのための形態である少なくとも3つの取付け要素を備える、項目16に記載の心臓ステント−弁送達システム。
(項目32)前記ステント−弁の前記少なくとも取付け要素が、前記ステントホルダーの対応する数の相補的構造体への離脱可能な取付けのための形態である少なくとも6つの取付け要素を備える、項目16に記載の心臓ステント−弁送達システム。
(項目33)前記ステント−弁が:
少なくとも1つの交連ポスト;および
前記少なくとも1つの取付け要素を備える格子構造体を備える、項目16に記載の心臓ステント−弁送達システム。
(項目34)前記ステント−弁の前記格子構造体が、前記少なくとも1つの交連ポストを前記少なくとも1つの取付け要素に接続するための少なくとも1つの支持要素をさらに備える、項目33に記載の心臓ステント−弁送達システム。
(項目35)心臓ステント−弁を移植部位に送達する方法であって:
該ステント−弁を送達デバイスに離脱可能に取り付ける工程;
該ステント−弁を該移植部位に折り畳まれた形態で送達する工程;
該ステント−弁を送達デバイスに取り付けた状態に維持しながら、該ステント−弁を部分的に近位方向に拡大する工程;および
該ステント−弁が該部分的に拡大された形態にあるとき、該ステント−弁に対する決定をなす工程、を包含する、方法。
(項目36)前記決定をなす工程が、前記ステント−弁が前記移植部位に正確に位置決めされているか否かを決定することを包含する、項目35に記載の方法。
(項目37)前記ステント−弁を前記折り畳まれた形態に戻す工程、および該ステント−弁が前記移植位置に正確に位置決めされていないとき、該ステント−弁を再位置決めする工程をさらに包含する、項目36に記載の方法。
(項目38)前記決定をなす工程が、前記ステント−弁の弁構成要素が適正に機能しているか否か決定することを包含する、項目35に記載の方法。
(項目39)前記弁構成要素が適正に機能しているか否か決定することが、該弁構成要素が十分な血液−流れを許容するか否かを試験することを包含する、項目38に記載の方法。
(項目40)前記ステント−弁が適正に機能していないときに、該ステント−弁を前記折り畳まれた形態に戻す工程、および該ステント−弁を患者の身体から取り外す工程をさらに包含する、項目38に記載の方法。
(項目41)前記決定をなす工程が肯定応答を生じるときに、前記送達デバイスから前記ステント−弁を離脱させることにより、該ステント−弁を完全に拡大させる工程をさらに包含する、項目35に記載の方法。
(項目42)前記ステント−弁を移植部位に送達する工程が、該ステント−弁を心臓弁の置換のために心臓に送達することを包含する項目35に記載の方法であって、該送達することがさらに:
患者の身体に、肋間腔を通ってアクセスすること;および
心尖で左心室を貫通することを包含する、項目35に記載の方法。
(項目43)前記アクセスすることが、患者の身体に、第5肋間腔を通ってアクセスすることを包含する、項目42に記載の方法。
図1A〜3Bは、例えば、不全の(例えば、変性した)大動脈弁、僧帽弁、または肺動脈心臓弁(例えば、小児患者における)の置換における使用のための、本発明のいくつかの実施形態による、構成要素100、200、および300を示す。より詳細には、図1Aおよび1Bは、弁構成要素100を示す。図2A〜2Cは、弁構成要素100を収容するためのステント構成要素200を示す。図3Aおよび3Bは、ステント構成要素200およ弁構成要素100を収容するためのステント構成要素300を示す。構成要素100および200を含むデバイスは、単一−ステント−弁と称され得る。構成要素300をさらに含むデバイスは、二重−ステント−弁と称され得る。
Claims (15)
- ヒト身体内での使用のための置換弁であって:
第1の部分(802)、弁構成要素(100)を収容するための第2の部分(804)、および第3の部分(806)を備えるステント構成要素(800、900、1000)、ならびに該第2の部分(804)に取り付けられた弁構成要素(100)を備え、
該第3の部分(806)が、送達デバイス(2300、2400、2500、2600)への離脱可能な取付けのための形態である少なくとも1つの取付け要素(808、814、836、902、1002)を備え、
該ステント構成要素(800、900、1000)が格子構造を含み、該第1の部分(802)が該第2の部分(804)および/または該第3の部分(806)より密な格子セルの集団を有することを特徴とする、置換弁。 - 前記少なくとも1つの取付け要素(808、814、836、902、1002)が、前記送達デバイス(2300、2400、2500、2600)の相捕的要素への離脱可能な取付けのための形態である円形または卵形の開口部を備える、請求項1に記載の置換弁。
- 前記少なくとも1つの取付け要素(808、814、836、902、1002)が、前記送達デバイス(2300、2400、2500、2600)の相捕的要素への離脱可能な取付けのための形態であるワイヤ、フックまたはストラップを備える、請求項1〜2のいずれか1項に記載の置換弁。
- 前記第3の部分(806)が、少なくとも2つの取付け要素(808、814、836、902、1002)を備える、請求項1〜3のいずれか1項に記載の置換弁。
- 前記第3の部分(806)が、3つの取付け要素(808、814、836、902、1002)を備える、請求項1〜3のいずれか1項に記載の置換弁。
- 前記第3の部分(806)が、6つの取付け要素(808、814、836、902、1002)を備える、請求項1〜3のいずれか1項に記載の置換弁。
- 前記第1の部分(802)が複数の独立に屈曲可能な要素(816)を含み、各々の屈曲可能な要素(816)が前記第1の部分(802)の格子セルの単一の閉鎖されたセルを含む、請求項1に記載の置換弁。
- 前記第3の部分(806)が、前記ステント構成要素(1000)の周の周りで円を集合的に形成するブレーシング要素(1004)を備える、請求項1に記載の置換弁。
- 前記ステント構成要素の格子構造が:
少なくとも1つの交連ポスト;および
該少なくとも1つの交連ポストを前記少なくとも1つの取付け要素(808、814、836、902、1002)に接続するための少なくとも1つの支持要素を備える、請求項1に記載の置換弁。 - 前記少なくとも1つの取付け要素(808、814、836、902、1002)が、前記ステント構成要素(200、800)の中心軸に向かって少なくとも部分的に内方に突出する、請求項1〜9のいずれか1項に記載の置換弁。
- 前記第3の部分(806)が、前記第2の部分(804)の直径より小さい直径を有する、請求項1〜10のいずれか1項に記載の置換弁。
- 前記第1の部分(802)が固定要素を備え、該固定要素が環状溝を備える、請求項7に記載の置換弁。
- 前記環状溝が前記複数の独立に屈曲可能な要素(816)から形成され、各々の屈曲可能な要素(816)が屈曲する変形を備え、その位置が、取付けられた一対の支柱(818、820)の長さによって決定される、請求項12に記載の置換弁。
- 前記取付け要素(808、814、836、902、1002)が、開口部、フック、またはストラップを形成するワイヤを備える、請求項1〜13のいずれか1項に記載の置換弁。
- 前記第2の部分(804)が、該第2の部分(804)の外表面から外方に突出する少なくとも1つのロック要素を備える、請求項1〜14のいずれか1項に記載の置換弁。
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