JP2022530764A - 生来の弁輪での側方送達される人工心臓弁を展開するための締め付けデバイス及び方法 - Google Patents
生来の弁輪での側方送達される人工心臓弁を展開するための締め付けデバイス及び方法 Download PDFInfo
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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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
-
- 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
- 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
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
-
- 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
- A61F2250/0004—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
- A61F2250/0069—Sealing means
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
本願は、2019年5月4日に出願された「Cinch Device and Method for Deployment of an Orthogonal Prosthetic Heart Valve in a Native Annulus」と題された米国仮出願シリアル番号第62/843,424号の優先権及び利益を主張するものであり、その開示は、全体が、参照により本明細書に組み込まれる。
統合された締め付け装置
本明細書の説明及び特許請求の範囲において、「統合された締め付け装置」、「締め付け」という用語は、テザーを引っ張ると環状支持フレームの周囲壁を折り畳む/束ねる/湾曲させて、そのことで弁全体の円周を縮小し、弁を生来の弁輪に展開しやすくするように、弁のフレームに取り付けられた細長いテザーを表すために使用される。テザーは、人工弁の本体/周囲壁及び/またはカラー部分に取り付けられているか(外側)、またはそれを通って延びる(内側)。締め付け装置は、好ましい実施形態では、放射線不透過性マーカーまたは放射線不透過性材料または構造を有し得、その結果、送達システムカテーテルは、弁が取り付けられているか、または取り付けられる予定の部位に、患者の身体を通って誘導され得る。1つの好ましい実施形態では、直交弁の送達は、人工三尖弁心臓弁置換を固定するために、大腿静脈を通って下大静脈(IVC)に、心臓の右心房に(長さ方向の送達、高さ及び幅の圧縮)至り、その後、環状下部アンカーを取り付けるためのアンカーシステムのIVCの送達が続く。
本明細書の説明及び特許請求の範囲において、「側方送達される」、「側方送達」、または「直交」という用語は、本発明の弁が圧縮され、従来の経カテーテル心臓弁と比較して約90度の角度で送達されることを説明するために使用される。従来の弁は、送達カテーテルの長さ方向の軸に平行な中心円筒軸を有し、閉じたアンブレラをスリーブから押し出すのと同じように、送達カテーテルの端から展開される。本発明の弁は、圧縮され、横向きに送達される。従来の弁は、送達カテーテルの内径が許す範囲でしか拡張できない。従来の弁の拡張直径を大きくする努力は、あまりにも多くの材料と構造をあまりにも小さなスペースに圧縮しようとするという問題に遭遇した。数学的には、直交という用語は、2つの線または平面間の90度の交差角度を指す。使用される場合、本明細書において「実質的に直交する」という用語は、75から105度の範囲の交差角度を指す。交差角度または直交角度は、(i)送達カテーテルの長さ方向の円筒軸と本発明の圧縮弁の長軸との間の関係(長軸は従来の弁の中心円筒軸に垂直である)、及び(ii)本発明の圧縮または膨張した弁の長軸と、人工心臓弁を通る血流によって定められる軸との間の関係であって、例えば、生来の弁輪を経て心房から心室へなどの、身体の一部または心臓の腔部から、身体の別の下流の部分または心臓の腔部へと血液が流れている関係、の両方を指す。
本明細書の説明及び特許請求の範囲において、「経カテーテル」という用語は、心腔に展開されるカテーテルの管腔内の医療機器または器具にアクセスし、制御し、送達するプロセス、ならびにプロセスなどによって送達または管理されるアイテムを定めるために使用される。経カテーテルアクセスには、大腿動脈と大腿静脈、上腕動脈と上腕静脈、頸動脈と頸静脈、肋間(肋骨)腔、及び剣状突起下部が含まれることが知られている。経カテーテルは経管腔と同義であり得、心臓弁の送達に関連するため、「経皮的」という用語に機能的に関連している。
本明細書の説明及び特許請求の範囲において、「環状支持フレーム」、ならびに「ワイヤフレーム」または「フランジ」または「カラー」という用語は、生来の弁輪内に静置し、弁尖構造、流れ制御構成要素、または柔軟な往復スリーブまたはスリーブ弁の取り付け要素として使用される三次元構造の構成要素を指す。
環状支持フレームは、ニチノールまたは同様の合金などの耐久性のある生体適合性構造材料から作製されたリング、または円筒形または円錐形のチューブであり得、環状支持フレームは、構造的な材料を編組ワイヤフレーム、レーザカットされたワイヤフレーム、またはワイヤループとして製造することによって形成される。環状支持フレームは、ワイヤ材料自体の厚さを考慮して、高さが約5~60mmであり、外径寸法Rが30~80mm、内径寸法が31~79mmである。述べたように、環状支持フレームは、リング形状、円筒形状、円錐のチューブの形状の側面の外形を有することができるが、フラットコーン形状、逆フラットコーン形状(上部の方が狭く、底部の方が広い)、凹型円筒(壁が内側に曲がっている)、凸型円筒(壁が膨らんでいる)、角のある砂時計型、湾曲した目盛り付き砂時計型、上部がフレア、下部がフレア、またはその両方のリングまたは円筒及び側面の外形をも有し得る。1つの好ましい実施形態では、三尖弁の弁輪に配置された人工心臓弁で使用される環状支持フレームは、弁が取り付けられている解剖学的構造によって決まる複雑な形状を有し得る。例えば、三尖弁の弁輪では、三尖弁の円周は丸味を帯びた楕円であり得、中隔壁は実質的に垂直であることが知られており、三尖弁は前後線に沿って、病状で拡大することが知られている。したがって、人工心臓弁は、ほぼ管状の構成で開始し、熱で成形して、心房封止用の上部心房カフまたはフランジ、及び円周の約60~80%の砂時計断面を有する下部経環状管型または円筒形セクションを設け、後部及び前部の環状セグメントに沿った生来の弁輪に一致させながらも、中隔環状セグメントに一致するように、環状円周の20~40%に沿って実質的に垂直に平坦なままにすることができる。
環状支持フレームは、任意選択で、心膜などの生体適合性材料で、部分的または完全に、内部または外部が覆われている。環状支持フレームはまた、任意選択で、ポリエステルまたはダクロン(登録商標)などの第2の生体適合性材料で、部分的または完全に外部が覆われ得る。
環状支持フレームは、人工心臓弁または流れ制御構造、例えば往復する圧縮可能スリーブが、管腔の直径全体に取り付けられている、中央軸方向管腔を有する。環状支持フレームはまた、生来の弁輪の内面に対して張力がかけられ、弱くなった環状リングに対する構造的開存性を与える。
環状支持フレームは、任意選択で、心房からスリーブに血液を導き、環状支持フレーム周辺の血液の漏れに対して封止するために使用される、心房の床部に展開するために、フレームの上(心房)縁に取り付けられた別個の心房用カラーを有し得る。環状支持フレームはまた、収縮期の逆流性漏出を防止するため、収縮期のデバイスの脱落を防止するため、心房用カラーに対して生来の弁輪または隣接する組織を挟むか圧縮するため、また任意選択でスリーブ/導管に取り付けて支えるために使用される、生来の弁輪のすぐ下の心室において展開すべく、フレームの下(心室)縁に取り付けられた別個の心室用カラーを、任意選択で有し得る。
環状支持フレームは、経カテーテル送達のために圧縮され得、自己拡張可能な形状記憶要素として、または経カテーテル拡張バルーンを使用して拡張可能であり得る。いくつかの実施形態は、心房用カラーと心室用カラーの両方を有し得るが、一方、本発明の範囲内の他の実施形態は、単一の心房用カラー、単一の心室用カラーのいずれかを有するか、または追加のカラー構造を有さない人工心臓弁を含む。
好ましくは、フレームは、レーザカットされたニチノールのチューブなどの超弾性金属構成要素、または平坦なシート、または編組ワイヤなどの他の同様に機能する材料から作製される。この材料は、フレーム/ステント、カラー、及び/またはアンカーに使用できる。本発明の範囲内で、他の形状記憶合金、ならびにカーボンナノチューブ、炭素繊維、金属繊維、ガラス繊維、及びポリマー繊維を含む複合材料を含むポリマー複合材料を使用することが企図されている。フレームは、編組、ワイヤ、またはレーザカットフレームとして構築され得ることが企図される。レーザカットフレームは、好ましくはニチノールで作られているが、ステンレス鋼、コバルトクロム、チタン、及びその他の機能的に同等の金属や合金でも非限定的に作られている。
締め付けテザーは、弁に解放可能に取り付けられ、テザーがどのように作動されるかについての様々なメカニズムを含む。一実施形態では、テザーの端部は解放装置を有し、テザーの残りの部分は、フレームに取り付けられたガイド穴またはチューブに通される。別の実施形態では、テザーは、弁の片側または両側(周囲壁)を1つの大きな曲がりまたは複数の小さな曲がりのいずれかで折り畳むために、複数の場所に取り付けられる。別の実施形態では、複数のテザーが存在する可能性がある。例えば、一実施形態では、弁の片側に2つのテザーがあり、片側だけを減らすことができる。別の実施形態では、中隔及び前部などの弁の反対側にテザーがあり得、弁の周囲を収縮または折り畳めるようにする。
ワイヤフレームの1つの可能な構造は、薄い、等直径のニチノールのチューブのレーザ切断を想定している。レーザカットは、細いニチノールのチューブに規則的なカットアウトを形成する。1つの好ましい実施形態では、ニチノールのチューブは拡張して、ダイアモンドの形状のセルから形成された三次元構造を形成する。構造はまた、追加の機能的な要素、例えば生体適合性カバー、組織アンカー、解放可能な展開及び回収制御ガイド、ノブ、アタッチメント、リギングなどの付属の構成要素を取り付けるためのループ、アンカーなどを有し得る。
ワイヤフレームの別の可能な構造は、ニチノールワイヤ及び単純な編組固定具を使用する単純な編組技術を利用することを想定している。ワイヤは、等直径のチューブが形成されるまで、パターンで編組固定具に巻かれる。第2に、編組ワイヤフレームは成形固定具に配置され、業界標準のニチノール成形法を使用して処理される。
本明細書の説明及び特許請求の範囲において、「流れ制御構成要素」という用語は、非限定的な意味で、処置済みまたは未処置の心膜などの可撓性生体適合性材料の二弁尖、三弁尖、四弁尖を有する弁尖構造を指す。それは、人工心臓弁として機能するために、環状支持フレームに縫い付けられるか結合される。このような弁は、心房から心室へ拡張期に流れる血液に対して開かれ、外面に加えられる収縮期心室圧から閉鎖する、三尖弁、僧帽弁、大動脈弁、または肺動脈弁などの心臓弁であり得る。開閉を順番に繰り返すことは「往復運動」と表現できる。流れ制御構成要素は、バルブ・イン・バルブの実施形態において、ボール弁(例えば、スターエドワーズ)、二葉弁(St.Jude)、傾斜ディスク弁(例えば、Bjork-Shiley)、ステント付き心膜心臓弁プロテーゼ(ウシ、ブタ、ヒツジ)(Edwardsラインの生体プロテーゼ、St.Judeの人工弁)、及び同種移植弁と自家移植弁を含む、多種多様な模造の(生体)人工心臓弁も含むことが企図されている。生体人工心膜弁には、生体人工大動脈弁、生体人工僧帽弁、生体人工三尖弁、及び生体人工肺動脈弁が含まれ得る。
「経カテーテル」という用語は、心腔(または身体の他の所望の位置)に展開されるカテーテルの管腔内の医療機器または器具にアクセスし、制御し、及び/または送達するプロセス、ならびにプロセスなどによって送達または管理されるアイテムを定めるために使用される。経カテーテルアクセスは、大腿動脈及び/または静脈の内腔を介した、上腕動脈及び/または静脈の内腔を介した、頸動脈の内腔を介した、頸静脈の内腔を介した、肋間(リブ)を介した及び/または下部剣状突起空間、及び/または同様のものを介した心臓アクセスを含むことが知られている。経カテーテルは経管腔と同義であり得、心臓弁の送達に関連するため、「経皮的」という用語に機能的に関連している。本明細書で使用される場合、「管腔」という用語は、円筒またはチューブの内部を指すことができる。「ボア」という用語は、管腔の内径を指す場合がある。
本明細書の説明及び特許請求の範囲において、「組織アンカー」または「ひだ組織アンカー」または「二次組織アンカー」、または「ダーツ」または「ピン」という用語は、上部心房フレームを通常、カラーの周辺またはその近くにある生来の弁輪組織を接続する固定用デバイスを指す。アンカーは、組織の貫通を回避するように配置され、捕捉された組織の2つのプレート状のカラー、またはアンカー、それ自体または統合された固定ワイヤとの圧縮力にまさに依存し得るか、生来の組織を貫通してアンカーを供給するか、または両方の組み合わせであり得る。アンカーは、特殊な固定メカニズムを備えていても良く、例えば、溝とフランジ付きショルダーを備えた尖った先端が挙げられ、これは、アンカーを取り付けることができる嵌合された開口のアレイに挿入または設置されるが、開口の周囲がフランジ付きショルダーの近くの溝に係止されているときは、脱落を防ぐ。固定ワイヤは、結び目、縫合糸、ワイヤ圧着、カム機構を有するワイヤロック、またはそれらの組み合わせを含む任意の取り付けまたは固定機構によって、ピンの反対側のカラーに取り付けまたは固定することができる。
「ポスト」という用語は、スポークフレームに取り付けられ得て、軸方向に、または柔軟なスリーブの中心を下って、または柔軟なスリーブの縫い目内を延びる、ニチノールまたはPEEKなどの剛性または半剛性の長さの材料を指す。スリーブはポストに取り付けられていない場合もあれば、スリーブが直接または間接的にポストに取り付けられている場合もある。
プロテーゼ(prosthesis)または人工(prosthetic)という用語は、両方共、解剖学的部分の完全な置換、例えば生来の弁を置換する新しい機械式弁、及び既存の解剖学的部分の代わりをする、及び/または支援、修復、または改善をする医療機器を包含する。パッシブアシストケージの内部に取り付けるために、本発明は、多種多様な模造の(生体)人工心臓弁を企図している。本発明の範囲内であると企図されているのは、ボール弁(例えば、スターエドワーズ)、二葉弁(St.Jude)、傾斜ディスク弁(例えば、Bjork-Shiley)、ステント付き心膜心臓弁プロテーゼ(ウシ、ブタ、ヒツジ)(Edwardsラインの生体プロテーゼ、St.Judeの人工心臓弁)、及び同種移植弁と自家移植弁である。生体人工心膜弁については、生体人工大動脈弁、生体人工僧帽弁、生体人工三尖弁、及び生体人工肺動脈弁を使用することが企図されている。
テザーは、生体適合性ポリマー縫合材料などの外科用グレードの材料から作られている。そのような材料の非限定的な例には、超高分子量ポリエチレン(UHMWPE)、2-0 exPFTE(ポリテトラフルオロエチレン)または2-0ポリプロピレンが含まれる。一実施形態では、テザーは非弾性である。心周期の間の弁の一際高度な応諾性を付与するために、1つまたは複数のテザーが任意選択で弾性であり得ることもまた企図される。
デバイスは、タインまたはバーブを使用することにより、弁輪の中に静置させることができる。これらは、1つまたは複数のテザーと組み合わせて、またはその代わりに使用できる。タインまたはバーブは、隣接する組織への付着をもたらすように配置されている。タインは、バルーンカテーテルを使用するなどの機械的手段によって弁輪組織に押し込まれる。1つの非限定的な実施形態では、タインは、任意選択で、ワイヤフレーム本体の拡張時に、弁輪組織を貫通し、回転し、また弁輪組織をしっかりと保持する半円形のフックであり得る。アンカーは、送達カテーテルを介した1つまたは複数のアンカーのワイヤにわたる送達によって展開される。カテーテルは、アンカー設定ツール、力適用ツール、フック、スネアリングツール、切断ツール、高周波及び放射線視覚化ツール及びマーカー、ならびに縫合糸/スレッドツールを含む、様々なアンカーツールを送達するための複数の軸方向の管腔を有し得る。アンカー(複数可)が調節帯に取り付けられると、テンショニングツールを使用して、移植された弁に接続するテザーの長さを調整し、適切に機能するように、必要に応じて、インプラントを調整及び固定することができる。アンカーはバネ式であり得、アンカー(複数可)のテザー面に組み込まれたテザー取り付けまたはテザー捕捉機構を有し得ることもまた企図される。アンカーはまた、心筋内へのアンカーの内部成長を促進するための、ポリエステル繊維などの内部成長材料を有し得る。
いくつかの実施形態では、構成要素は、ポリウレタンまたはポリテトラフルオロエチレン(PTFE)などの合成材料(複数可)から製造することができる。薄くて耐久性のある合成材料が企図される場合(例えば、カバリング用)、延伸PTFEまたはポリエステルなどの合成ポリマー材料を任意選択で使用することができる。他の適切な材料は、任意選択で、熱可塑性ポリカーボネートウレタン、ポリエーテルウレタン、セグメント化ポリエーテルウレタン、シリコーンポリエーテルウレタン、ポリエーテルエーテルケトン(PEEK)、シリコーン-ポリカーボネートウレタン、ポリプロピレン、ポリエチレン、低密度ポリエチレン、高密度ポリエチレン、及び超高分子量ポリエチレンを含み得る。追加の生体適合性ポリマーは、任意選択で、エラストマー、ポリオレフィン、ポリエチレングリコール、ポリエーテルスルホン、ポリスルホン、ポリビニルピロリドン、ポリビニルクロリド、他のフルオロポリマー、ポリエステル、ポリエチレンテレフタレート(PET)(例えば、ダクロン)、ポリ-L-乳酸(PLLA)、ポリグリコール酸(PGA)、ポリ(D,L-ラクチド/グリコリド)コポリマー(PDLA)、シリコーンポリエステル、ポリアミド(ナイロン)、PTFE、伸長PTFE、延伸PTFE、ポリウレタン、シロキサンポリマー及び/またはオリゴマー、及び/またはポリラクトン、及びそれを使用するブロックコポリマーを含み得る。
いくつかの実施形態において、弁フレーム及び/またはその構成要素は、生体適合性金属、金属合金、ポリマー被覆金属などから製造され得る。適切な生体適合性金属及び/または金属合金には、ステンレス鋼(例えば、316Lステンレス鋼)、コバルトクロム(Co-Cr)合金、ニッケルチタン合金(例えば、ニチノール(登録商標))などが含まれ得る。適切なポリマーコーティングには、ポリエチレン酢酸ビニル(PEVA)、ポリブチルメタクリレート(PBMA)、トランスリュートスチレンイソプレンブタジエン(SIBS)コポリマー、ポリ乳酸、ポリエステル、ポリラクチド、D-乳酸ポリ乳酸(DLPLA)などが含まれ得る。
弁フレーム及び/またはその部分または構成要素のいずれかは、心膜などの生体適合性材料で、部分的または完全に、内部または外部が覆われ得る。弁フレームはまた、任意選択で、ポリエチレンまたはダクロン(登録商標)などの第2の生体適合性材料で、部分的または完全に外部が覆われ得る。開示された実施形態は、ウシ(ウシの心膜)、ヒツジ(ヒツジの心膜)、ブタ(ブタの心膜)、またはウマ(ウマの心膜)などの動物の、化学的に安定化された心膜組織である、生体組織などの組織を使用し得る。好ましくは、組織はウシ心膜組織である。適切な組織の例には、Duraguard(登録商標)、Peri-Guard(登録商標)、及びVascu-Guard(登録商標)の製品で使用されているものが含まれ、すべての製品は、現在外科手術で使用されており、一般に30月齢に満たないウシから採取されて販売されている。
薬物溶出ワイヤフレームが、本明細書での使用で企図されている。DESは基本的に、ワイヤフレームプラットフォーム、コーティング、及び薬剤の3つの部分からなる。ポリマーフリーDESの例は、抗増殖剤と管腔外コーティングが薬物の担体として利用されてきたような、パクリタキセルを備えたAmazonia CroCo(L605)コバルトクロム(Co-Cr)ワイヤフレームを使用するAmazon Pax(MINVASYS)。抗増殖薬Biolimus A9の担体表面として修飾された管腔外コーティングを備えたベースとして、ステンレス鋼を使用するBioFreedom(Biosensors Inc.)。316Lステンレス鋼ワイヤフレームを薬物タクロリムスのベースとして使用し、統合されたターボストラティックカルボフィルムを薬物担体として利用している、Optima(CID S.r.l.)。GenXステンレス鋼(316L)をベースとして使用し、薬物シロリムスの担体としてミクロポーラスヒドロキシアパタイトコーティングを利用している、VESTA sync(MIV Therapeutics)。プロブコールと併用して、薬物シロリムスのベースとして316Lステンレス鋼を使用した、YUKONチョイス(トランスルミナ)。
直交した送達ステップ:折り畳み可能で圧縮可能な人工三尖弁を設け、弁を送達カテーテルに横向きに装填し、環状下部遠位タブのガイドワイヤループに通される事前に配置されたガイドワイヤにわたりIVCまたはSVCを介して弁を心臓に進め、弁を部分的に排出して遠位環状下部タブを配置し、弁本体のチャネルを遠位環状リングに対してくさびで留め、心房用カラーを弁輪組織領域の上面に配置し、弁の弁尖が機能し始め、締め付けシステムを使用して弁本体の近位側を放射状に縮小し、生来の弁輪に静置することによって弁を完全に展開し、環状下部近位固定タブを拡張/展開することを可能にする。
好ましい実施形態では、本発明は、直交して送達される経カテーテル人工心臓弁用フレームを製造するためのプロセスを含み、プロセスは、加法的または減法的な金属または金属合金の製造を使用して、自己拡張型の環状支持フレームを製造することを含み、加法的な金属または金属合金の製造は、3D印刷または直接金属レーザ焼結(粉末溶融)であり、減法的な金属または金属合金の製造は、フォトリソグラフィー、レーザ焼結/切断、CNC機械加工、放電加工である。
別の好ましい実施形態では、移植可能な人工心臓弁が、環状支持フレームの片側から圧縮構成に一方的にローリングするステップと、環状支持フレームの2つの対向する側から、圧縮構成に両側にローリングするステップと、環状支持フレームを長軸に実質的に平行である2つの平行なパネルに平坦化し、次に平坦化された環状支持フレームを圧縮構成にローリングするステップと、弁の垂直方向の寸法を上から下に減らすために、垂直軸に沿って環状支持フレームを平坦化するステップと、からなる群から選択されるステップを使用して、圧縮構成にローリングさせるか折り畳まれることを含む方法が、提供される。
これより図面を参照すると、図1は、実施形態による概略的な側面の断面図である。図1は、弁100の下部経環状部分106の周囲(円周)がどのように内側に締め付けられ得るかを示している。これにより、弁を大型の経環状円周、例えば5~20%、多くの場合10~15%で設計することができ、生来の弁輪内部での弁の緊密な適合を促進し、弁周囲漏出(PVL)に対する良好な封止をもたらす。締め付けプロセスは、近位側壁を内側に引っ張り、経環状セクション106の円周を減少させる。これにより、弁の展開中に、大型の弁が生来の弁輪に落下することが可能になる。次に、弁が必要に応じて静置されると、経環状セクションが全周またはほぼ全周に押し戻され、それによって、生来の弁輪に人工弁がしっかりと封止されて適合する。
Claims (37)
- 統合された締め付け装置を有する、直交して送達される経カテーテル人工心臓弁であって、
自己拡張型環状支持フレームであって、拡張構成で中央垂直軸に外接する中央チャネル及び外周壁を有し、心房封止カラーが、前記外周壁の上端の少なくとも一部の周りに配置され、前記環状支持フレームが遠位側及び近位側を有する、前記自己拡張型環状支持フレームと、
遠位端で前記環状支持フレームに解放可能に取り付けられた細長いテザーまたはストラップを有する統合された締め付け装置であって、前記テザーまたはストラップは操縦可能なカテーテルの制御ハンドルから作動可能で、前記環状支持フレームの前記近位側の半径方向のサイズを締め付けまたは縮小する、前記締め付け装置と、
前記環状支持フレーム内に取り付けられ、前記弁の流入端を通る第1の方向への血流を可能にし、前記弁の流出端を通る、前記第1の方向とは反対の第2の方向への血流を遮断するように構成された流れ制御構成要素と、
前記周囲壁の遠位部分に取り付けられ、前記周囲壁から離れて延びる、環状下部遠位固定タブまたはテンションアームと、
前記周囲壁の近位部分に取り付けられ、前記周囲壁から離れて延びる、環状下部近位固定タブまたはテンションアームと、
を含み、
前記弁は、身体の所望の位置に移植するための送達カテーテルを使用して身体に導入するための圧縮構成に圧縮可能であり、前記圧縮構成は、中央垂直軸に対して45~135度の間の交差角度で水平軸に沿って配向され、前記中央垂直軸に対して45~135度の間の交差角度で水平軸を有する拡張構成に拡張可能であり、
前記弁の前記圧縮構成の前記水平軸は、前記送達カテーテルの長さ方向の円筒軸に実質的に平行である、前記弁。 - 前記統合された締め付け装置が2つ以上のテザーを有する、請求項1に記載の弁。
- 前記統合された締め付け装置は、単一プルテザー機構、二重テザー押し出しシステム、マルチテザーツイスト機構、またはベルト締め付け機構を備える、請求項1に記載の弁。
- 前記テザーが編組ポリエチレン、処置された心膜組織、ePTFE、またはニチノールである、請求項2に記載の弁。
- 前記テザーまたはストラップは、歯の部分を有し、前記解放要素は、歯に係合する解放可能な爪要素を有する、請求項1に記載の弁。
- 前記第1のテザーまたはストラップは、前記周囲壁の中隔側の上部に取り付けられ、前記第2のテザーまたはストラップは、前記周囲壁の前記中隔側の底部に取り付けられる、請求項1に記載の弁。
- 前記テザーまたはストラップは、前記環状下部近位固定タブに解放可能に取り付けられ、前記近位固定タブは、前記周囲壁に対して折り畳まれた位置から、前記周囲壁から離れるように折り畳まれる拡張位置に移動するように構成され、
前記近位固定タブは、タブ固定要素を有し、前記テザーまたはストラップは、前記タブ固定要素と協働して前記近位固定タブを前記折り畳まれた位置から前記拡張位置に移動させるタブ解放要素を有する、請求項1に記載の弁。 - 前記環状支持フレームが生体適合性材料で覆われている、請求項1に記載の弁。
- 前記環状支持フレームは、前記中央垂直軸に実質的に直交する配向及びセル形状を有する複数の圧縮可能なワイヤセルから構成され、前記環状支持フレームが、垂直圧縮構成、ローリング圧縮構成、または折り畳まれた圧縮構成に構成されるときワイヤセルのひずみを最小限に抑える、請求項1に記載の弁。
- 前記環状支持フレームは、下部本体部分及び上部カラー部分を有し、
拡張構成の前記下部本体部分は、漏斗、円筒、フラットコーン、または円形双曲面から選択される形状を形成する、請求項1に記載の弁。 - 前記環状支持フレームが、編組、ワイヤ、またはレーザカットワイヤフレームから構成され、前記環状支持フレームが生体適合性材料で覆われている、請求項1に記載の弁。
- 前記環状支持フレームが、40~80mmの直径R、20~60mmの直径r、及び5~60mmの高さを有する平らな円錐形の側面の外形を有する、請求項1に記載の弁。
- 前記環状支持フレームが内面及び外面を有し、前記内面及び前記外面が、心膜組織で覆われた前記内面、合成ポリエステル織物で覆われた前記外面、及び心膜組織で覆われた前記内面と合成ポリエステル織物で覆われた前記外面の双方、から選択される生体適合性材料で覆われている、請求項1に記載の弁。
- 前記環状支持フレームが、40~80mmの上部直径R1、50~70mmの下部直径R2、20~60mmの内径r、及び5~60mmの高さである砂時計形状の側面の外形を有する、請求項1に記載の弁。
- 拡張構成の前記弁は、前記第1の方向に実質的に平行である中央垂直軸を有する、請求項1に記載の弁。
- 前記流れ制御構成要素は、20~40mmの内径を有し、心膜材料の複数の弁尖が結合されて、流入端で丸い円筒を形成し、流出端で平坦な閉鎖可能な開口を有する、請求項1に記載の弁。
- 前記流れ制御構成要素は、前記流れ制御構成要素に統合または取り付けられた1つまたは複数の長手方向支持体に支えられ、前記1つまたは複数の長手方向支持体は、剛性または半剛性のポスト、剛性または半剛性のリブ、剛性または半剛性のバテン、剛性または半剛性のパネル、及びそれらの組み合わせから選択される、請求項1に記載の弁。
- 前記環状下部遠位固定タブは、ワイヤループ、ワイヤフレーム、レーザカットフレーム、一体型フレームセクション、またはステントから構成され、前記遠位固定タブは、前記環状支持フレームの前記遠位側から約20~40mm離れて延びる、請求項1に記載の弁。
- 前記近位固定タブは、ワイヤループ、ワイヤフレーム、レーザカットフレーム、一体型フレームセクション、またはステントから構成され、前記近位固定タブは、前記環状支持フレームの前記近位側から約10~20mm離れて延びる、請求項1に記載の弁。
- 前記環状支持フレームの遠位上端に取り付けられた上部遠位固定タブをさらに含み、前記上部遠位固定タブがワイヤループ、ワイヤフレーム、レーザカットフレーム、一体型フレームセクション、またはステントから構成され、前記環状支持フレームから約10~20mm離れて延びる、請求項1に記載の弁。
- 生来の組織と係合するための前記環状支持フレームに接続された少なくとも1つの組織アンカーを含む、請求項1に記載の弁。
- 前記外周壁は、第1のフラットパネルである前壁部分と、第2のフラットパネルである後壁部分とを含み、
近位折り畳み領域及び遠位折り畳み領域は、それぞれ、縫い目、ファブリックパネル、剛性ヒンジ、またはいずれのワイヤセルもない柔軟なファブリックスパンを含む、請求項1に記載の弁。 - 前記環状支持フレームが、編組ワイヤセル、レーザカットワイヤセル、フォトリソグラフィーで生成されたワイヤセル、3D印刷ワイヤセル、波形状、ジグザグ形状、またはスパイラル形状に断続的に接続された単線ワイヤ、及びそれらの組み合わせから形成されたワイヤセル、からなる群から選択される圧縮可能ワイヤセルから構成される、請求項1に記載の弁。
- 直交して送達される経カテーテル人工心臓弁フレームを製造するためのプロセスであって、
加法的または減法的な金属または金属合金の製造を使用して、
自己拡張型環状支持フレームであって、拡張構成で中央垂直軸に外接する中央チャネル及び外周壁を有し、心房封止カラーが、前記外周壁の上端の少なくとも一部の周りに配置され、前記環状支持フレームが遠位側及び近位側を有する、前記自己拡張型環状支持フレームと、
遠位端で前記環状支持フレームに解放可能に取り付けられた細長いテザーまたはストラップを含む統合された締め付け装置であって、前記テザーまたはストラップは、前記テザーまたはストラップの近位端にある制御ハンドルから作動される前記遠位端に解放要素を有し、前記解放要素は前記環状支持フレームの固定フレーム要素と協働するように構成され、前記テザーまたはストラップが前記遠位端に近位の位置で前記周囲壁に取り付けられた少なくとも1つのスライド可能なガイド要素の管腔内にスライド可能に収容される、前記締め付け装置と、
前記環状支持フレーム内に取り付けられ、前記弁の流入端を通る第1の方向への血流を可能にし、前記弁の流出端を通る、前記第1の方向とは反対の第2の方向への血流を遮断するように構成された流れ制御構成要素と、
前記環状支持フレームに取り付けられた統合された環状下部アンカーシステムであって、遠位端で剛性ループに取り付けられた細長いテザーまたはストラップ、及び前記細長いテザーまたはストラップにスライド可能に取り付けられたスライド可能なロック要素を含む、前記アンカーシステムと、
前記環状支持フレームの前記遠位側に取り付けられた遠位固定タブと、
前記環状支持フレームの前記近位側に取り付けられた近位固定タブと、
を製造することを含み、
前記弁は、身体の所望の位置に移植するための送達カテーテルを使用して身体に導入するための圧縮構成に圧縮可能であり、前記圧縮構成は、前記中央垂直軸に対して45~135度の間の交差角度で水平軸に沿って配向され、前記中央垂直軸に対して45~135度の間の交差角度で水平軸を有する拡張構成に拡張可能であり、
前記弁の前記圧縮構成の前記水平軸は、前記送達カテーテルの長さ方向の円筒軸に実質的に平行であり、
前記弁は、約5~60mmの高さ及び約25~80mmの直径を有し、
前記加法的な金属または金属合金の製造は、3D印刷または直接金属レーザ焼結(粉末溶融)であり、
前記減法的な金属または金属合金の製造は、フォトリソグラフィー、レーザ焼結/切断、CNC機械加工、放電加工である、
前記プロセス。 - (ii)前記弁フレーム内に流れ制御構成要素を取り付けるステップであって、前記流れ制御構成要素は、前記中央垂直軸に沿って前記流れ制御構成要素の流入端を通る血流を可能にし、前記弁の流出端を通る血流を遮断するように構成される、前記取り付けるステップと、
前記弁フレームの外面を心膜材料または同様の生体適合性材料で覆うステップと、
をさらに含む、請求項24に記載のプロセス。 - 移植可能な人工心臓弁を圧縮して、送達カテーテルから前記弁を長さ方向に直交して解放するための方法であって、
前記移植可能な人工心臓弁を平坦化、ローリング、または折り畳んで圧縮構成にすることであって、前記弁の前記圧縮構成の長軸が前記送達カテーテルの長さ方向の円筒軸に実質的に平行である、前記圧縮構成にすることを含み、
前記移植可能な人工心臓弁は、
前記環状支持フレーム内に取り付けられ、前記弁の流入端を通る第1の方向への血流を可能にし、前記弁の流出端を通る、前記第1の方向とは反対の第2の方向への血流を遮断するように構成された流れ制御構成要素と、
前記環状支持フレームに取り付けられた統合された環状下部アンカーシステムと、
前記環状支持フレームの遠位側に取り付けられた遠位固定タブと、
前記環状支持フレームの近位側に取り付けられた近位固定タブと、
を含む、前記方法。 - 前記移植可能な人工心臓弁は、
前記環状支持フレームの片側から圧縮構成に一方的にローリングするステップと、
前記環状支持フレームの2つの対向する側から、圧縮構成に両側にローリングするステップと、
前記環状支持フレームを前記長軸に実質的に平行である2つの平行なパネルに平坦化し、前記平坦化された環状支持フレームを圧縮構成にローリングするステップと、
前記弁の垂直方向の寸法を上から下に減らすために、垂直軸に沿って前記環状支持フレームを平坦化するステップと、
からなる群から選択されるステップを使用して圧縮構成にローリングさせるか、または折り畳まれる、請求項20に記載の方法。 - 身体の所望の位置への移植可能な人工心臓弁を直交送達するための方法であって、
送達カテーテルを身体の前記所望の位置に進めさせ、拡張可能な人工心臓弁を、身体の前記所望の位置に、前記弁を前記送達カテーテルから解放することによって送達するステップを含み、
前記弁は、
自己拡張型環状支持フレームであって、拡張構成で中央垂直軸に外接する中央チャネル及び外周壁を有し、心房封止カラーが、前記外周壁の上端の少なくとも一部の周りに配置され、前記環状支持フレームが遠位側及び近位側を有する、前記自己拡張型環状支持フレームと、
統合された締め付け装置と、
前記環状支持フレーム内に取り付けられ、前記弁の流入端を通る第1の方向への血流を可能にし、前記弁の流出端を通る、前記第1の方向とは反対の第2の方向への血流を遮断するように構成された流れ制御構成要素と、
前記環状支持フレームの遠位側に取り付けられた遠位固定タブと、
前記環状支持フレームの近位側に取り付けられた近位固定タブと、
を含み、
前記弁は、拡張構成から5~30%縮小された楕円円周を有する、または前記上端の長軸が直径の5~30%縮小された締め付け構成を有する締め付け構成に、締め付け可能であり、
前記弁は、身体の所望の位置に移植するための送達カテーテルを使用して身体に導入するための高さ5~10mm及び幅5~10mmを有する圧縮構成に圧縮可能であり、前記圧縮構成は、第1の方向に対して45~135度の間の交差角度で配向される長軸を有し、前記第1の方向に対して45~135度の間の交差角度で配向される長軸を有する拡張構成に拡張可能であり、
前記弁の前記圧縮構成の前記長軸は、前記送達カテーテルの長さ方向の円筒軸に実質的に平行である、前記方法。 - 前記送達カテーテルから前記弁を解放することは、
(i)前記弁の前記遠位側に解放可能に接続されている剛性の細長い押し出しロッド/ドローワイヤを使用して、前記送達カテーテルから前記弁を引き出すことであって、前記押し出しロッドを前記送達カテーテルから遠ざけるように前進させることが、前記圧縮された弁を前記送達カテーテルから引き出す、前記引き出すこと、または
(ii)前記弁の前記近位側に解放可能に接続された剛性の細長い押し出しロッドを使用して、前記送達カテーテルから前記弁を押し出すことであって、前記押し出しロッドを前記送達カテーテルから前進させることが、前記圧縮された弁を前記送達カテーテルから押し出すこと、
からなるステップから選択される、請求項28に記載の方法。 - 前記弁に取り付けられた1つまたは複数の組織アンカーを生来の組織に固定する追加のステップを含む、請求項28に記載の方法。
- 前記心臓弁プロテーゼの前記遠位固定タブを右心室の右心室流出路に配置する追加のステップを含む、請求項28に記載の方法。
- 前記心臓弁プロテーゼの前記遠位固定タブを前記右心室の前記右心室流出路に配置する追加のステップと、
上部遠位固定タブを環状上部位置に配置する追加のステップと、を含み、
前記上部遠位固定タブは、前記心室の方向に環状上部の下向きの力をもたらし、前記遠位固定タブは、前記心房の方向に環状下部の上向きの力をもたらす、請求項28に記載の方法。 - 前記弁輪の平面に平行な軸に沿って、操縦可能なカテーテルを使用して前記心臓弁プロテーゼを回転させる追加のステップを含む、請求項28に記載の方法。
- 身体への移植可能な人工心臓弁の直交送達のための方法であって、
ガイドワイヤの遠位端を遠位位置に前進させるステップであって、前記遠位位置は、肺動脈または心臓の左心室であり、前記ガイドワイヤは、患者の外側から大腿静脈アクセスまたは腕頭静脈アクセスを使用して始まり、下大静脈または上大静脈を経て右心房に延び、前記右心房から三尖弁を通って前記肺動脈に延びるか、または前記右心房から心房中隔を横切って経中隔アクセスで僧帽弁を通って、左心室に延びる、前記前進させるステップと、
送達カテーテルを前記ガイドワイヤにわたり標的位置まで前進させるステップであって、前記標的位置は、前記三尖弁の右心房または前記僧帽弁の左心房である、前記前進させるステップと、
直交して圧縮された自己拡張型人工心臓弁を前進させ、身体の前記標的位置に送達するステップと、
を含み、
前記弁の圧縮構成は、前記送達カテーテルの長さ方向の円筒軸に実質的に平行な長軸を有し、
前記弁の前記拡張構成は、約5~60mmの高さ及び約25~80mmの直径を有し、
前記弁は、
前記環状支持フレーム内に取り付けられ、前記弁の流入端を通る第1の方向への血流を可能にし、前記弁の流出端を通る、前記第1の方向と反対の第2の方向への血流を遮断するように構成された流れ制御構成要素を有する環状支持フレームと、
前記環状支持フレームに取り付けられた統合された環状下部アンカーシステムと、
を含み、
遠位固定タブが、前記環状支持フレームの遠位側に取り付けられ、前記ガイドワイヤは、前記遠位固定タブ上またはその内部のスレッド式開口にねじ込まれ、
少なくとも1つの近位固定タブが、前記環状支持フレームの近位側に取り付けられ、
細長いシースを含む弁前進ツールであって、前記ガイドワイヤが前記シースの管腔内にあり、前記シースの前記外径が前記遠位固定タブの前記スレッド式開口の前記内径よりも大きく、前記シースが遠位方向で前記ガイドワイヤにわたり前進し、前記シースの遠位端が前記スレッド式開口の近位表面に接触するとき、前記弁は、前記シースが前記遠位固定タブに与える前記遠位方向の引っ張り力によって、前記送達カテーテルを通って遠位に進む、前記弁前進ツールを含み、
(iv)前記シースを前記ガイドワイヤにわたって前進させ、前記遠位固定タブを前記標的位置の所望の固定領域に配置することにより、前記送達カテーテルから前記弁を部分的に解放するステップであって、
前記所望の固定領域は、右心室の右心室流出路(RVOT)、及び僧帽弁のA1-P1前外側交連の下方の環状下部領域から選択され、
前記遠位固定タブを配置することにより、前記弁を、前記弁及び前記送達カテーテルの前記水平軸に対して局所化された弁輪面に対して少なくとも30度の上昇角度で保持し、
前記弁を部分的に解放することが、血液が部分的に前記人工弁の周り及び前記生来の弁尖を通って流れ、部分的に前記人工弁の前記流れ制御構成要素を通って流れ、生来の弁尖を通る流れからの漸進的な血流の移行をもたらし、前記人工弁を通る流れを完全にするのを可能にする、
前記解放するステップと、
(v)前記シースを前記ガイドワイヤにわたり前進させ、前記心室の方向に下向きの力を加えることによって、前記弁を前記生来の弁輪に静置させることにより、前記送達カテーテルからの前記弁全体の解放を完了するステップと、
(vi)前記少なくとも1つの近位固定タブを第2の所望の固定領域に静置させるステップと、
を含む、前記方法。 - 前記弁に取り付けられた1つまたは複数の組織アンカーを生来の組織に固定する追加のステップを含む、請求項21に記載の方法。
- 経カテーテル人工心臓弁の移植中の血行力学的流れを改善するための方法であって、
送達カテーテルを身体の所望の位置に前進させ、請求項1に記載の弁を身体の前記所望の位置に送達することと、
前記部分的に解放された弁の周りの血流を確立し、前記流れ制御構成要素を通る血流を確立するために、前記送達カテーテルから前記弁を部分的に解放することと、
位置決めカテーテルまたはワイヤで前記弁への取り付けを維持しながら、前記送達カテーテルから前記弁を完全に解放して、前記流れ制御構成要素を通る血流の増加及び前記弁の周りの血流の減少に移行することと、
前記弁を最終的に取り付けられた位置に展開して、前記流れ制御構成要素を通る血流を完全にし、前記弁の周りの血流を最小限にするか、まったくないように移行し、前記位置決めカテーテルまたはワイヤを前記弁から外して引き抜くことと、
を含む、前記方法。 - 前記遠位固定タブが、前記弁の部分的解放から前記弁の完全な解放へ前記移行中に、RVOTに配置された前記RVOTタブである、請求項36に記載の方法。
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WO2021146515A1 (en) | 2020-01-17 | 2021-07-22 | Vdyne, Inc. | Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery |
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2020
- 2020-05-04 CA CA3138875A patent/CA3138875A1/en active Pending
- 2020-05-04 JP JP2021563105A patent/JP2022530764A/ja active Pending
- 2020-05-04 AU AU2020267390A patent/AU2020267390A1/en active Pending
- 2020-05-04 WO PCT/US2020/031390 patent/WO2020227249A1/en unknown
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- 2020-05-04 EP EP20801681.6A patent/EP3965701A4/en active Pending
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US11202706B2 (en) | 2021-12-21 |
US20210236280A1 (en) | 2021-08-05 |
CN114072106A (zh) | 2022-02-18 |
WO2020227249A1 (en) | 2020-11-12 |
US20220096226A1 (en) | 2022-03-31 |
AU2020267390A1 (en) | 2021-11-11 |
EP3965701A1 (en) | 2022-03-16 |
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