JP2020533076A - 僧帽弁逆流を治療するための軸対称の調節可能なデバイス - Google Patents
僧帽弁逆流を治療するための軸対称の調節可能なデバイス Download PDFInfo
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- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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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
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- A—HUMAN NECESSITIES
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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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2230/0069—Three-dimensional shapes cylindrical
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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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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Abstract
Description
11 心臓壁
12 右心房
14 右心室
16 左心房
18 左心室
19 心尖部
20 三尖弁
22 肺動脈弁
24 僧帽弁
25 僧帽弁弁輪
26 大動脈弁
28 上大静脈
30 下大静脈
32 肺動脈
34 右室腱索
36 右室乳頭筋
38 肺静脈
40 大動脈
42a 弁尖
42p 弁尖
44 左室腱索
46 左室乳頭筋
48 弁尖
50 デバイス
52 支持係留部
54 封止要素
60 封止要素
62a 長さ
62b 長さ
62c 長さ
62d 長さ
63 マーカー
64a 最大直径
64b 最大直径
64c 最大直径
64d 最大直径
65 マーカー
66 拡張制御要素
70 支持フレーム
72 円筒本体
74a 送達長さ
74b 展開長さ
76a 送達最大直径
76b 展開最大直径
78 切れ目
80 リブ状要素
90 支持フレーム
92 ストランド
94 管状構造体
96 遠位端
98 近位端
100a 長さ
100b 長さ
100c 長さ
102a 最大直径
102b 最大直径
102c 最大直径
104 直径
106 直径
108 中央部分
110 支持フレーム
112a 長径
112b 長径
112c 長径
112d 長径
114a 短径
114b 短径
114c 短径
114d 短径
115 マーカー
117 マーカー
120 内部テザリング機構
122 テザー線
124 第1の端部
126 第2の端部
130 ロッド
132 第1の端部
134 係止機構
136 歯状要素
140 直動ねじ機構
142 ねじ
144 第1の端部
146 ねじ受けナット
148 エクステンダ
150 デバイス
152 係留要素
154 封止要素
156 上部係留要素、心房係留部分
158 心房アーム
160 心房アーム遠位端
161 拡張された直径
162 心室部分、下部係留要素
164 心室アーム
166 心室アーム遠位端、心室係留部分
167 拡張された直径
168 中央部分
170 遠位端
172 カテーテル
180 デバイス
182 係留要素
184 封止要素
186 上部心房部分、上部係留要素
188 上部心房アーム
189 中間湾曲部
190 上部心房アーム遠位端
191 拡張された直径
192 下部心房部分、下部係留要素
194 下部心房アーム
196 下部心房アーム遠位端
197 拡張された直径
200 封止要素支持部分
202 カテーテル
204 遠位端
206 開口
208 縫合
210 デバイス
212 封止要素
214 テザー
216 係留部、カテーテル
218 遠位端
220 カテーテル
222 開口
230 係留部フレーム
232 中央部分
234 上部
236 下部
238a 切れ目
238b 切れ目
238c 切れ目
240a リブ状要素
240b リブ状要素
240c リブ状要素
242 流体閉塞外被
244 封止要素
246 頂部開口
248 下部開口
Claims (38)
- 軸対称または楕円の頂面断面輪郭を有する人工封止要素であって、僧帽弁弁尖間の位置で心臓の自己僧帽弁の弁輪内に展開されて、心室収縮期に自己僧帽弁弁尖と接触してシールを生成して左心室から左心房への血液の逆流を防ぐような寸法を有し、概ね細長くて半径方向につぶされた送達形態を備え、短縮化されて半径方向に拡張されて軸対称または楕円の頂面断面輪郭になる展開形態をさらに備え、前記心臓が拍動すると前記自己僧帽弁弁尖が開閉することができるような寸法をさらに有する人工封止要素と、
前記心臓内で展開するように適合された係留要素であって、前記人工封止要素に結合され、自己弁尖間の所望の位置に前記人工封止要素を支持するように構成され、前記心臓内で展開されると、前記僧帽弁弁尖間に前記人工封止要素を配置するような寸法を有する係留要素と、
を備える、僧帽弁を治療するためのデバイス。 - 前記係留要素が、延在して心臓組織と接触するように構成された上部と、延在して心臓組織と接触するように構成された下部と、を有する、請求項1に記載のデバイス。
- 前記係留要素の上部が、延在して僧帽弁弁輪に隣接する心房組織と接触することによって前記心臓内で係留されるように構成され、前記係留要素の下部が、延在して前記僧帽弁弁輪に隣接する心室組織と接触することによって前記心臓内で係留されるように構成された、請求項2に記載のデバイス。
- 前記係留要素の上部が、心房の頂部に向かって延在して心房組織と接触することによって前記心臓内で係留されるように構成され、前記係留要素の下部が、延在して前記僧帽弁の弁輪に隣接する心房組織と接触することによって前記心臓内で係留されるように構成された、請求項2に記載のデバイス。
- 前記係留要素が、25mmから70mmの間の拡張された直径を有する、請求項1に記載のデバイス。
- 前記人工封止要素が、10mm以下の送達直径と、10mmから35mmの拡張された直径と、を有する、請求項1に記載のデバイス。
- 拡張されたときの前記人工封止要素が細長く、前記人工封止要素が、10mm以下の送達直径と、10mmから35mmの拡張された長径と、5mmから15mmの拡張された短径とを有する、請求項1に記載のデバイス。
- 前記係留要素が、半径方向の圧縮力がない状態で拡張されたときに軸対称である、請求項1に記載のデバイス。
- 前記係留要素が記憶材料を含む、請求項1に記載のデバイス。
- 送達カテーテルと、
自己の心臓弁に隣接する心臓組織と係合するように構成された係留部材であって、つぶすことができ、かつ拡張することができ、半径方向の圧縮力がない状態で拡張されたときに頂面輪郭が軸対称であるように構成された係留部材、および
つぶすことができ、かつ拡張することができ、拡張された形態では、軸対称または楕円の頂面輪郭を備えた人工封止部材であって、前記係留部材が、長くされて半径方向に圧縮された形態から、短くされて半径方向に拡張された形態に拡張するように構成され、前記拡張された状態では、前記心臓弁の弁尖間の隙間を塞いで逆流を減少させるように適合され、前記拡張された状態では、収縮期に自己弁尖と係合するが、心臓が拍動すると前記自己弁尖が開閉することができるように適合された人工封止部材
を備える人工デバイスと、
を備え、
前記係留部材および前記人工封止部材が、前記送達カテーテル内につぶされた状態で配置されるように構成された、心臓弁を治療するためのシステム。 - 前記人工封止部材が、前記係留部材に対して軸周りに回転するように構成された、請求項10に記載のシステム。
- 前記人工封止部材が、前記係留部材に対して選択的に回転させられるように構成され、前記人工デバイスが、前記人工封止部材を前記係留部材に対して選択された回転箇所に選択的に係止するように構成された係止部を備える、請求項11に記載のシステム。
- 前記係留部材が、上部および下部を備え、前記上部が、自己弁に隣接する心房組織と係合するように適合され、前記下部が、前記自己弁に隣接する心室組織と係合するように適合された、請求項10に記載のシステム。
- 前記送達カテーテルが、遠位開口を備え、前記係留部材および前記人工封止部材が、前進させられて、つぶされた状態で前記送達カテーテルの遠位開口を出入りするように構成された、請求項10に記載のシステム。
- 送達カテーテルの遠位端を患者の心臓の心臓弁の位置に前進させるステップであって、前記遠位端内には、係留部材および封止部材を有する人工デバイスがあり、前記封止部材が、対称な形態に拡張されて収縮期に自己弁尖と係合するが、前記心臓が拍動すると、前記自己弁尖が依然として開閉することができるように構成された、ステップと、
心臓組織と係合して前記係留部材を前記心臓内に係留するために、自己弁輪における、または自己弁輪に隣接する、前記心臓の位置に前記係留部材の部分を前記送達カテーテルから放出するステップと、
前記封止部材を前記送達カテーテルから放出するステップと、
前記封止部材を拡張するステップであって、前記封止部材が、拡張するとき、長さを短くするが直径を大きくし、前記封止部材が、拡張後、軸対称または楕円の頂面輪郭を備える、ステップと、
を含み、
それにより、前記係留部材および前記封止部材を放出した後、収縮期に前記自己弁尖が前記封止部材に対して接合し、前記心臓が拍動すると前記自己弁尖が開閉することができるように、前記封止部材が前記心臓弁の弁尖間に配置された、心臓弁の機能を改善するための方法。 - 拡張後の前記封止部材が、軸対称の頂面輪郭を備える、請求項15に記載の方法。
- 前記心臓弁が僧帽弁であり、拡張後の前記封止部材が、楕円の頂面輪郭を備える、請求項15に記載の方法。
- 前記封止部材をその中心軸の周りに、前記自己弁輪に対して所望の回転位置まで回転させるステップであって、前記封止部材が、前記封止部材に対する弁尖の接合を改善するように前記自己弁輪内で前記自己弁尖と位置合わせされる、ステップと、
前記封止部材を前記所望の回転位置に係止するステップと、
をさらに含む、請求項17に記載の方法。 - 前記封止部材をその中心軸の周りに回転させるステップが、前記封止部材の長軸を前記僧帽弁の交連部間の線に実質的に平行(10度以内)になるように位置合わせするステップを含む、請求項18に記載の方法。
- 封止要素を拡張する間、弁性能を監視するステップと、
前記封止要素の最終的な拡張形態を、弁性能が最大化される形態に設定するステップと、
をさらに含む、請求項15に記載の方法。 - 前記係留部材が、上部および下部を備え、前記上部と前記下部とが別々に展開される、請求項15に記載の方法。
- 前記係留部材の下部を前記送達カテーテルから放出するステップが、前記係留部材の上部を前記送達カテーテルから放出するステップの前に生じる、請求項21に記載の方法。
- 前記係留部材の上部を前記送達カテーテルから放出するステップが、前記係留部材の下部を前記送達カテーテルから放出するステップの前に生じる、請求項21に記載の方法。
- 前記係留部材の上部が、僧帽弁の弁輪に隣接する心房組織と係合するように構成された心房部分を備え、前記係留部材の下部が、前記僧帽弁の前記弁輪に隣接する心室組織と係合するように構成された心室部分を備える、請求項21に記載の方法。
- 前記係留部材の上部が、心房の頂部に向いて組織と係合し、前記係留部材の下部が、前記心房の底部に向いて、前記自己弁輪に隣接する組織と係合する状態で、前記係留部材が、心房内に展開されるように構成される、請求項21に記載の方法。
- 前記係留部材が、拡張して心房組織と係合するように構成された上部、拡張して前記封止部材を支持するように構成された中央部分、および拡張して心室組織と係合するように構成された下部を備え、前記係留部材を展開するステップが、
前記上部を解放して心房組織と係合させるステップと、
前記下部を解放して心室組織と係合させるステップと、
を含む、請求項15に記載の方法。 - 前記係留部材が、前記送達カテーテルの前記遠位端内に、圧縮された状態で取り付けられた自己拡張可能なフレームを備える、請求項15に記載の方法。
- 前記係留部材および前記封止部材が、前記患者の血管構造を通して経皮的に送達される、請求項15に記載の方法。
- 前記係留部材および前記封止部材が、自己弁に経心尖的に送達される、請求項15に記載の方法。
- 前記係留部材が、拡張された形態を備え、その形態では、前記係留部材が、半径方向の圧縮力がない状態で軸対称の頂面輪郭を有する、請求項15に記載の方法。
- 前記係留部材が、拡張された形態を備え、その形態では、前記係留部材が、半径方向の圧縮力がない状態で細長い頂面輪郭を有する、請求項30に記載の方法。
- 展開後の前記人工デバイスが、収縮期に前記封止部材に対して前記自己弁尖が係合することを除いて、前記自己弁尖または前記自己弁輪を外向きに拡張しない、請求項15に記載の方法。
- 自己弁尖間に係留されて弁機能を改善するように構成された封止要素であって、
送達形態および拡張された形態を備えたメッシュ支持フレームであって、前記送達形態では、前記メッシュ支持フレームが、送達直径を有して実質的に管状であり、前記拡張された形態では、前記メッシュ支持フレームが、半径方向に拡張されて、その中央部において拡張された中央直径になるが、前記メッシュ支持フレームの端部は前記送達直径のままであり、前記拡張された直径が、前記送達直径の少なくとも2倍である、メッシュ支持フレームと、
前記メッシュ支持フレームを覆う外被であって、前記外被が、血液がその中を通ることを防ぐ、外被と、
を備える、封止要素。 - 前記拡張された中央直径が、前記送達直径の少なくとも3倍である、請求項33に記載の封止要素。
- 前記拡張された中央直径が、前記送達直径の少なくとも5倍である、請求項33に記載の封止要素。
- 前記拡張された形態の前記封止要素が、軸対称の頂面輪郭を備える、請求項33に記載の封止要素。
- 前記拡張された形態の前記封止要素が、細長い頂面輪郭を備える、請求項33に記載の封止要素。
- 前記拡張された形態の前記封止要素が、楕円の頂面輪郭を備える、請求項37に記載の封止要素。
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