JP2015509023A - 僧帽弁ドッキングデバイス、システム、および方法 - Google Patents
僧帽弁ドッキングデバイス、システム、および方法 Download PDFInfo
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- JP2015509023A JP2015509023A JP2014555338A JP2014555338A JP2015509023A JP 2015509023 A JP2015509023 A JP 2015509023A JP 2014555338 A JP2014555338 A JP 2014555338A JP 2014555338 A JP2014555338 A JP 2014555338A JP 2015509023 A JP2015509023 A JP 2015509023A
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- coil
- mitral valve
- helical anchor
- anchor
- valve
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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
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Abstract
Description
本出願は、その開示が参照により本明細書に組み込まれている、2012年11月26日に出願した米国仮出願第61/796,964号(係属)、2012年9月27日に出願した米国仮出願第61/744,468号(係属)、2012年5月3日に出願した米国仮出願第61/687,898号(係属)、2012年1月31日に出願した米国仮出願第61/592,796号(係属)の優先権を主張するものである。
6 心尖
10 左心室
10a 心室壁
14 心臓
18 大動脈
22 大動脈弁
26 右心室
30 ガイドワイヤ
34 内腔
38 前弁尖
42 後弁尖
44 自然僧帽弁
46 左心房
46a 心房壁
48 腱索
56、60 乳頭筋
64 送出カテーテル
68 コイルガイドカテーテル
72 螺旋状アンカー
80 僧帽弁交連部
84 弁周または輪
88 ステム
92 U字形部分
96 内腔
100 先端部
104 下側コイル
108 上側コイル
108a、108b コイル
120 プロテーゼ
122、124 人工弁尖
126 ステント構造
130 螺旋状アンカー
132 下側コイル
134 上側コイル
140 アンカー
142、144 コイル
146 接続セグメント
150 螺旋状アンカー
152 曲がり
154 間隙
156 コイル
160 螺旋状アンカー
162 テール状延長部
164 下側コイル
164a、164b コイル
180 送出装置
182 外部鞘
184 内部シャフト
186 収束先端部
190 螺旋状アンカー
192 コイル
192a コイル
194 固着アーム
194a、194b ワイヤ部分
200 送出カテーテル
202 内腔
210 右心房
212 下大静脈
214 上大静脈
220 周カフ
222 固定端部
224 自由端部
232 のフック
230 ステントドック
234 鎖線または軸
236 頂点
238 一番下側のセル
239 ステントドック
240 ステントドック
242 両面フック
244 セル
250 フック
252 蛇行ワイヤ
254 曲がり
256 中央保持ワイヤ
260 ワイヤ
262 フック
264 外殻または中空構造物
266 開口
270 V字形部分
280 ステントドック
280a 心房部分
280b 弁固着部分
284 心室フック
290 ストラット
292 平面
302 カテーテル
304 心房中隔
310 コイルガイドカテーテル
312 ステム
314 U字形部分
316 下側コイル
320 螺旋状アンカー
322 上側コイル
330 螺旋状アンカー
332a 曲がり
340 コイルガイドカテーテル
340a 遠位先端部
342 ステム
344 U字形部分
346 下側コイル
348 上側コイル
350 ステントドック
350b 弁保持部分
352 カテーテル
354 送出カテーテル
356 フック
360 弁プロテーゼ
362、364 人工弁尖
370 螺旋状アンカー
372 大動脈ガイドワイヤ
374 位置決め用螺旋部
376 内腔
378 導入器
380 コイルガイドカテーテル
380a 遠位先端部
382 ステム
384 U字形部分
390 コイル
400 螺旋状アンカー
402 位置決め用螺旋部
404 カテーテル
406 コイルガイドカテーテル
408 ステム
410 U字形部分
420 螺旋状アンカー
420a 先端部
422 ガイドワイヤ
428 コイルガイドカテーテル
430 引き紐
432 中央内腔
436 ステム
438 第2の湾曲部
440 結び目
442 コイルまたは曲がり
444 曲がり
450 螺旋状アンカー
452 スネア
454 カテーテルまたはチューブ
456 コイルガイドカテーテル
460 先端部
470 コイルガイドカテーテル
472 螺旋状アンカー
474 コイルガイドカテーテルのステム
476 遠位端
478 第2の湾曲部
480 湾曲部
482 先端部
490 螺旋状アンカー
490a 内腔
492 ガイドワイヤ
494 コイルガイドカテーテル
500 螺旋状アンカー
502 把持具
504 コイルガイドカテーテル
504a 末端部
504b ステム
504c U字形部分
506 端部
508、510 顎部
512 U字形曲がり
520 代替的把持具
522、524 顎部
526 カテーテル
530、532 コイル
534、536 コイル
540 コイルガイドカテーテル
542、544 顎部
560 コイルガイドカテーテル
564 膜延長部
570 U字形部分
572 螺旋状アンカー
580 スネアカテーテル
582 縫合糸
584 結び目
590 弁尖アンカー
592 カテーテル
594 テール
596 組織縫合糸ロッカー
600 第2のスネアカテーテル
612 アンカー
630 弁プロテーゼ
632 螺旋状コイル
634 スレッドまたは溝
636 コイル
650 螺旋状アンカー
650a 被覆
652 曲がり
654、656 曲がり
660 第2のコイル
Claims (50)
- 僧帽弁プロテーゼをドッキングするためのシステムであって、
ステム部分と第1の湾曲形状で前記ステム部分に接続される遠位部分とを備えるコイルガイドカテーテルであって、前記遠位部分が、僧帽弁輪の湾曲に概ね沿うように構成された第2の湾曲形状を有し、前記第1の湾曲部分および前記第2の湾曲部分が、真っ直ぐな構成で送出されて、僧帽弁に近い心臓内で活性化されて前記第1の湾曲形状および前記第2の湾曲形状にするできる、コイルガイドカテーテルと、
前記コイルガイドカテーテル内に受容されて前記コイルガイドカテーテルから送出されるように構成された螺旋状アンカーであって、前記コイルガイドカテーテルから送出された後に、予め形成された螺旋状の構成を有する多重コイルとして形成され、且つ、前記コイルガイドカテーテルから完全に送出されてコイル部分が前記僧帽弁輪の上および下に埋め込まれる際に、人工僧帽弁を支持するように構成されている螺旋状アンカーと、
を備えるシステム。 - 患者の前記僧帽弁の位置に送出され、前記多重コイルの内側で膨脹して前記僧帽弁の弁尖と係合することができる人工弁をさらに備える、請求項1に記載のシステム。
- 前記人工弁は、前記人工弁と前記螺旋状アンカーとを結合させるために前記多重コイルと係合するように構成された溝を備える、請求項2に記載のシステム。
- 前記螺旋状アンカーは、形状記憶材料をさらに含む、請求項1に記載のシステム。
- 前記多重コイルは、隣接する次のコイルに比べて拡径されたコイルとして形成された末端のコイル部分を備え、前記末端のコイル部分は、前記コイル部分が前記僧帽弁輪の上および下に位置する状態で前記多重コイルが前記コイルガイドカテーテルから完全に送出されたときに、前記心臓の左心房壁と係合するように構成される、請求項1に記載のシステム。
- 前記螺旋状アンカーと結合され、前記僧帽弁の弁尖と係合するように構成された複数の固着アームをさらに備える、請求項1に記載のシステム。
- 前記固着アームは、フック状部材をさらに備える、請求項5に記載のシステム。
- 前記僧帽弁に対する相対的な前記螺旋状アンカーの配置を案内するために前記螺旋状アンカーと結合するように構成された接続要素を有する制御カテーテルをさらに備える、請求項1に記載のシステム。
- 前記制御カテーテルは、スネアカテーテルをさらに含む、請求項8に記載のシステム。
- 前記制御カテーテルは、把持具を持つカテーテルをさらに含む、請求項8に記載のシステム。
- 前記螺旋状アンカーは、前記接続要素を前記螺旋状アンカーに結合させることができるように構成された係合要素をさらに備える、請求項8に記載のシステム。
- 前記螺旋状アンカーの位置決めを補助するために前記コイルガイドカテーテルから送出されるように構成された位置決め用螺旋状部をさらに備える、請求項1に記載のシステム。
- 前記第2の湾曲部分と結合されると共に、前記螺旋状アンカーが送出されるときに前記僧帽弁の上への前記第2の湾曲部分の位置決めを補助するように構成された延長部をさらに備える、請求項1に記載のシステム。
- 前記延長部は、平坦な膜をさらに備える、請求項13に記載のシステム。
- アンカー送出カテーテルとアンカーとをさらに備え、前記アンカー送出カテーテルは、前記アンカーを前記僧帽弁の位置の組織内に送出させるために前記コイルガイドカテーテルと結合される、請求項1に記載のシステム。
- 前記螺旋状アンカーは、ソリッドワイヤをさらに備える、請求項1に記載のシステム。
- 前記螺旋状アンカーは、ガイドワイヤ上で送出されるように構成された中空のワイヤをさらに備える、請求項1に記載のシステム。
- 僧帽弁プロテーゼをドッキングするためのデバイスであって、
カテーテルから患者の僧帽弁の位置まで送出され、次いで膨張するように構成された膨張可能なステントであって、上側端部と下側端部とを有する膨張可能なステントと、
前記下側端部と結合されると共に、前記僧帽弁の弁尖と係合するように構成された複数の固着アームと、
を備えるデバイス。 - 前記固着アームは、フック状部材をさらに備える、請求項18に記載のデバイス。
- 前記フック状部材は、前記ステントが膨脹するときに寸法が変化する、請求項19に記載のデバイス。
- 前記膨張可能なステントは、膨張可能な心房部分と膨張可能な弁保持部分とをさらに備え、前記膨張可能な心房部分は心臓内の前記僧帽弁の位置で膨脹したときに左心房壁と係合するように構成され、前記弁保持部分は前記僧帽弁の弁尖と係合するように適合され、前記固着アームは前記弁保持部分と結合される、請求項18に記載のデバイス。
- 患者の心臓内に僧帽弁プロテーゼを埋め込む方法であって、
コイルガイドカテーテルを前記患者の前記心臓内の僧帽弁の位置に導くステップと、
予め形成された湾曲部分を、前記予め形成された湾曲部分の湾曲が僧帽弁輪の湾曲に概ね沿う状態で、概ね左心房内の前記僧帽弁の平面内に配置するステップと、
多重コイルの形の螺旋状アンカーを、前記螺旋状アンカーの一部が自然僧帽弁の上に来て一部が前記自然僧帽弁の下に来るように、前記コイルガイドカテーテルから送出するステップと、
前記僧帽弁プロテーゼが前記螺旋状アンカーによって支持されるように、前記僧帽弁プロテーゼを前記螺旋状アンカーの前記多重コイル内に埋め込むステップと、
を含む方法。 - 心臓組織を通して導入器を導くステップと、
前記導入器を通して前記コイルガイドカテーテルを前記僧帽弁の位置に導くステップと、
をさらに含む、請求項22に記載の方法。 - 前記患者の静脈系を通して前記コイルガイドカテーテルを前記僧帽弁の位置に経皮的に導くステップをさらに含む、請求項22に記載の方法。
- 制御要素を使用して前記螺旋状アンカーを前記自然僧帽弁に対する相対的な所望の位置に案内するステップをさらに含む、請求項22に記載の方法。
- 前記制御要素を使用する前記ステップは、
前記制御要素の一部を前記螺旋状アンカーの一部に結合するステップと、前記制御要素を使用して前記螺旋状アンカーを前記自然僧帽弁に対する相対的な適所に押し込んだり引き込んだりするステップとをさらに含む、請求項25に記載の方法。 - 前記螺旋状アンカーの先端部を一方の交連部のところで前記自然僧帽弁の弁尖の間および上に送出するステップと、前記僧帽弁の下の前記先端部を前記患者の左心室内に導くステップとをさらに含む、請求項22に記載の方法。
- 前記螺旋状アンカーの先端部を前記心臓の左心室内に送出させ、少なくとも1巻きのコイルを前記左心室内に配置するステップと、
続いて少なくとも1巻きのコイルを前記左心房内に送出させるステップと、
をさらに含む、請求項22に記載の方法。 - 前記僧帽弁プロテーゼと前記螺旋状アンカーの一部との間に織物製のカフを配置するステップをさらに含む、請求項22に記載の方法。
- 大動脈弁を通してガイドワイヤを大動脈内に配置するステップと、
前記螺旋状アンカーの位置決めを補助するための基準として前記ガイドワイヤを使用するステップと、
をさらに含む、請求項22に記載の方法。 - 位置決め用螺旋状部を前記僧帽弁の位置に送出させるステップと、
前記位置決め用螺旋状部の押し出し中に、前記螺旋状アンカーの位置決めを補助するためのガイドとして前記位置決め用螺旋状部を使用するステップと、
をさらに含む、請求項30に記載の方法。 - 前記螺旋状アンカーをガイドワイヤ上で押し出すステップをさらに含む、請求項22に記載の方法。
- 前記螺旋状アンカーを正確に押し出すために、前記予め形成された湾曲部分上の延長部を使用して、前記自然僧帽弁の上での前記予め成形された湾曲部分の配向及び位置決めを補助するステップをさらに含む、請求項22に記載の方法。
- 前記延長部が膜をさらに備え、
前記膜を前記自然僧帽弁の上側に当接させて配置するステップをさらに含む、請求項33に記載の方法。 - 前記螺旋状アンカー若しくは前記コイルガイドカテーテル、又はその両方を使用して組織アンカー送出カテーテルを前記僧帽弁の位置に案内するステップと、
前記組織アンカー送出カテーテルを使用して第1の組織アンカーを前記僧帽弁の位置の組織内に送出させるステップと、
をさらに含む、請求項22に記載の方法。 - 第2の組織アンカーを前記僧帽弁の位置の組織内に送出させるステップと、
前記第1の組織アンカーおよび前記第2の組織アンカーを一緒に固定して、前記僧帽弁の位置の前記組織に褶襞を形成するか、或いは、前記僧帽弁の位置の前記組織に近づけるステップと、
をさらに含む、請求項35に記載の方法。 - 少なくとも2巻きのコイルを左心室内の前記自然僧帽弁の下側に配置して前記自然僧帽弁の弁尖と係合させ、且つ、少なくとも2巻きのコイルを前記左心房内の前記自然僧帽弁の上側に配置して前記螺旋状アンカーの少なくとも一部を前記左心房の壁と係合させて前記螺旋状アンカーおよび前記僧帽弁プロテーゼを固定させるステップをさらに含む、請求項22に記載の方法。
- 前記僧帽弁プロテーゼを埋め込む前記ステップは、
前記僧帽弁プロテーゼが膨脹していない状態のまま、前記僧帽弁プロテーゼを前記多重コイル内の場所に送出するステップと、
前記僧帽弁プロテーゼが前記多重コイルによって支持されるように、前記僧帽弁プロテーゼを膨張させるステップと、
をさらに含む、請求項22に記載の方法。 - 前記僧帽弁プロテーゼを膨脹させる前記ステップは、
前記僧帽弁プロテーゼの一部を前記螺旋状アンカーの少なくとも1巻きのコイルと直接係合させるステップと、
弁尖が前記僧帽弁プロテーゼと前記螺旋状アンカーとの間に固定されるように、前記僧帽弁プロテーゼの別の部分を弁尖と係合させるステップと、
をさらに含む、請求項38に記載の方法。 - 前記螺旋状アンカーの少なくとも1つの大径コイル部分は、前記螺旋状アンカーの隣接する部分より大きい直径を有し、
前記螺旋状アンカーの前記大径コイル部分を自然僧帽弁輪の上の前記左心房の壁と係合させるステップをさらに含む、請求項22に記載の方法。 - 前記螺旋状アンカーは、前記螺旋状アンカーの下側部分に結合された複数の固着アームをさらに備え、
前記螺旋状アンカーおよび前記僧帽弁プロテーゼを固定させるのを補助するために、前記固着アームを前記自然僧帽弁の弁尖と係合させるステップをさらに含む、請求項22に記載の方法。 - 前記固着アームは、フック状部材をさらに備え、
前記自然僧帽弁の弁尖の下に前記フック状部材を係合させるステップをさらに含む、請求項41に記載の方法。 - 患者の心臓内に僧帽弁プロテーゼを埋め込む方法であって、
ステント送出カテーテルを前記患者の前記心臓内の僧帽弁の位置に導くステップと、
ステントドックを前記ステント送出カテーテルから伸ばすステップと、
左心房内で前記ステントドックの心房部分を、前記心房部分が前記左心房の壁と係合するように、膨脹させるステップと、
前記ステントドックの弁保持部分を膨脹させて自然僧帽弁の弁尖に当接させるステップと、
前記僧帽弁プロテーゼが前記ステントドックによって支持されるように、前記僧帽弁プロテーゼを前記弁保持部分内に埋め込むステップと、
を含む方法。 - 前記ステントドックは、複数の固着アームをさらに備え、
前記ステントドックおよび前記僧帽弁プロテーゼを固定させるのを補助するために、前記固着アームを前記自然僧帽弁の前記弁尖と係合させるステップをさらに含む、請求項43に記載の方法。 - 僧帽弁プロテーゼをドッキングするための螺旋状アンカーであって、コイルガイドカテーテル内に受容されて前記コイルガイドカテーテルから送出されるように構成された螺旋状アンカーにおいて、
前記螺旋状アンカーは、前記コイルガイドカテーテルから送出された後に、予め形成された螺旋状の構成を有する多重コイルを備え、且つ、前記コイルガイドカテーテルから完全に送出されてコイル部分が僧帽弁輪の上および下に埋め込まれる際に、人工僧帽弁を支持するように構成されており、
前記螺旋状アンカーは、遠位端部分を備え、前記遠位端部分は、前記遠位端部分が隣接する次のコイルから離間されるように、隣接する次のコイルに対して半径方向外側に向かって下向きに延在し、自然僧帽弁の交連部の間に送出されるように構成される、螺旋状アンカー。 - 僧帽弁プロテーゼをドッキングするための螺旋状アンカーであって、コイルガイドカテーテル内に受容されて前記コイルガイドカテーテルから送出されるように構成された螺旋状アンカーにおいて、
前記螺旋状アンカーは、前記コイルガイドカテーテルから送出された後に、予め形成された螺旋状の構成を有する多重コイルを備え、且つ、前記コイルガイドカテーテルから完全に送出されてコイル部分が僧帽弁輪の上および下に埋め込まれる際に、人工僧帽弁を支持するように構成されており、
前記多重コイルは、自然僧帽弁輪の上方に配置されるように構成された上側心房コイルと、前記自然僧帽弁輪の下方に配置されるように構成された下側心室コイルとを備えており、前記上側心房コイルと前記下側心室コイルとは隣り合っていると共に、前記上側心房コイルと前記下側心室コイルとの間には、埋め込みの際に前記上側心房コイルおよび前記下側心室コイルが僧帽弁の弁尖組織を捕捉しないように、前記多重コイルの埋め込み前に空間を形成する間隙がさらに設けられている、螺旋状アンカー。 - 前記上側心房コイルは、前記下側心室コイルより大きい直径を有し、埋め込み後に心臓の心房壁と係合するように構成される、請求項46に記載の螺旋状アンカー。
- 僧帽弁プロテーゼをドッキングするための螺旋状アンカーであって、コイルガイドカテーテル内に受容されて前記コイルガイドカテーテルから送出されるように構成された螺旋状アンカーにおいて、
前記螺旋状アンカーは、前記コイルガイドカテーテルから送出された後に、予め形成された螺旋状の構成を有する多重コイルを備え、且つ、前記コイルガイドカテーテルから完全に送出されてコイル部分が僧帽弁輪の上および下に埋め込まれる際に、人工僧帽弁を支持するように構成されており、
前記多重コイルは、自然僧帽弁輪の上方に配置されるように構成された上側心房コイルと、前記自然僧帽弁輪の下方に配置されるように構成された下側心室コイルとを備えており、前記上側心房コイルの平面から外に延在して前記上側心房コイルから離間する延長部が、心臓内への埋め込みの際に心房の壁と係合して安定化をもたらすように、さらに備えられている、螺旋状アンカー。 - 僧帽弁プロテーゼをドッキングするための螺旋状アンカーであって、コイルガイドカテーテル内に受容されて前記コイルガイドカテーテルから送出されるように構成された螺旋状アンカーにおいて、
前記螺旋状アンカーは、前記コイルガイドカテーテルから送出された後に、予め形成された螺旋状の構成を有する多重コイルを備え、且つ、前記コイルガイドカテーテルから完全に送出されてコイル部分が僧帽弁輪の上および下に埋め込まれる際に、人工僧帽弁を支持するように構成されており、
前記多重コイルは、複数の上側心房コイルと複数の下側心室コイルとを備え、前記上側心房コイルは、自然僧帽弁輪の上方に配置されると共に上向きに延在するように構成され、それによって、前記僧帽弁プロテーゼの位置が、僧帽弁輪に対する相対的な所望の高さに調整可能に位置決めされる、螺旋状アンカー。 - 前記複数の下側心室コイルは、その中に僧帽弁の弁尖を収容し、前記僧帽弁の前尖による大動脈弁の閉塞を防ぐように構成される、請求項49に記載の螺旋状アンカー。
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