JP7139339B2 - 覆われた人工心臓弁 - Google Patents
覆われた人工心臓弁 Download PDFInfo
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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
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- 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
- 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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- 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
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
-
- 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
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
-
- 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
- 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
- A61F2/2469—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 with resilient valve members, e.g. conical spiral
-
- 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
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2415—Manufacturing methods
-
- 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
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
-
- 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
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
- A61F2002/0086—Special surfaces of prostheses, e.g. for improving ingrowth for preferentially controlling or promoting the growth of specific types of cells or tissues
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
Description
この説明の目的で、本開示の実施形態のある態様、利点、および新規な特徴が本明細書に記載されている。開示された方法、器具、およびシステムは、決して制限するものと解釈すべきではない。代わりに、本開示は、単独の、また、互いとのさまざまな組み合わせおよび部分的組み合わせにおける、さまざまな開示された実施形態のすべての新規かつ非自明の特徴および態様に向けられている。方法、器具、およびシステムは、任意の特定の態様もしくは特徴またはその組み合わせに制限されず、開示された実施形態は、任意の1つまたは複数の特定の利点が存在するか、もしくは問題が解決されることを必要としない。
2 流入端部
3 流出端部
10 フレーム
11 交連取付ポスト
12 支柱部材
13 支柱部材
14 頂点
20 弁尖構造体
30 スカート
40 細線
60 リングアンカー
70 螺旋アンカー
80 心臓
82 左心房
84 左心室
86 僧帽弁
88 弁尖
90 腱索
92 乳頭筋
100 人工心臓弁
102 フレーム
104 支柱部材
106 流入端部
108 流出端部
110 弁尖
112 外側被覆
114 裏打ち層
116 クッション層
118 フラシ天表面
120 流入保護部分
122 流出保護部分
124 頂点
126 長手方向軸
128 遠位端部分
130 近位端部分
132 近位フラップ
134 遠位フラップ
136 クッション部分
138 ステンシル
146 近位エッジ
148 遠位エッジ
150 ストリップ部材
152 ストリップ部材
154 縫合線
156 縫合線
158 パイル
162 ベース層
164 パイル糸
166 ループ
170 内部表面
200 人工弁
202 外側被覆
204 クッション層
206 第1の層
208 第2の層
210 スペーサ層
212 開口部
214 パイル糸
300 螺旋アンカー
302 中心領域
304 下方領域
306 上方領域
308 延長部分
310 貫通孔
400 人工心臓弁
402 フレーム
404 支柱部材
406 流入端部
408 流出端部
410 弁尖
412 外側被覆
414 クッション層
416 流入保護部分
418 流出保護部分
420 頂点
422 流入端部分
424 ストリップ部材
426 第1の周方向エッジ部分
428 第2の周方向エッジ部分
430 内側スカート
432 外部表面
434 縫合糸
435 縫合糸
436 ストリップ部材
438 第1の周方向エッジ部分
440 内側表面
442 第2の周方向エッジ部分
444 流出端部分
446 縫合糸
447 縫合糸
448 縫合線
450 縫合線
454 第2の表面
500 人工心臓弁
502 フレーム
504 支柱部材
506 頂点
508 流入端部
510 流出端部
514 外側被覆
516 クッション層
518 流入保護部分
520 流出保護部分
522 第1の周方向エッジ部分
524 第2の周方向エッジ部分
526 エッジ
528 エッジ
530 滑らかな層
532 外側表面
534 第2の滑らかな層
536 第1の周方向エッジ
538 第2の周方向エッジ
540 第1の周方向エッジ
542 第2の周方向エッジ
600 人工弁
602 フレーム
604 支柱部材
606 頂点
608 流入端部
610 流出端部
612 弁尖
614 第1の被覆
616 第2の被覆
618 流入端部分
620 流出端部分
622 最も上方の周方向エッジ
624 最も下方の周方向エッジ
626 ストリップ
628 縫合糸
630 接合部
634 開口部
636 シャフト
638 交連ウィンドウ
640 内側スカート
700 外側被覆
702 クッション層
704 フラシ天の外部表面
706 流入保護部分
708 流出保護部分
712 経糸
714 緯糸
716 かさ高加工フィラメント
800 密封部材
802 ベース層
804 パイル層
806 列
808 列
810 列
Claims (11)
- 人工心臓弁であって、
複数の支柱部材を含み、かつ流入端部および流出端部を有する、フレームと、
少なくとも部分的に前記フレームの内部に位置する弁尖構造体と、
前記フレームの周りに配された被覆と、を含み、前記被覆は、第1の層および第2の層を含み、前記第2の層は、フラシ天表面を有し、前記第1の層は、前記第2の層の周方向エッジ部分上に折り返され、前記支柱部材を越えて前記人工心臓弁の長手方向軸に沿った方向に延びる保護部分を形成し、
前記保護部分は、前記フレームの前記流入端部に隣接して位置する第1の保護部分であり、前記被覆は、前記フレームの前記流出端部に隣接して位置する第2の保護部分をさらに含み、
前記第1の保護部分の前記第1の層は、前記フレームの前記流入端部において前記第2の層の前記周方向エッジ部分上に折り返されたストリップ部材として構成され、
前記第2の保護部分の第1の層は、前記フレームの前記流出端部において前記第2の層の周方向エッジ部分上に折り返されたストリップ部材として構成される、人工心臓弁。 - 前記第1の層は、前記第2の層の内部表面に沿って、前記フレームの前記流入端部から前記フレームの前記流出端部まで延び、前記フレームの前記流出端部において前記第2の層の周方向エッジ上に折り返されて、前記第2の保護部分を形成する、請求項1に記載の人工心臓弁。
- 前記第1の保護部分の前記ストリップ部材は、前記フレームの前記流入端部において前記支柱部材のそれぞれの頂点を封入し、
前記第2の保護部分の前記ストリップ部材は、前記フレームの前記流出端部において前記支柱部材のそれぞれの頂点を封入する、請求項2に記載の人工心臓弁。 - 前記第2の層は、織物層と、複数のパイル糸を含むフラシ天パイル層とを有する布を含む、請求項1から3のいずれか一項に記載の人工心臓弁。
- 前記パイル糸は、ループパイルを形成するように配列されるか、またはカットパイルを形成するように切断される、請求項4に記載の人工心臓弁。
- 前記第1の層は、組織層を含む、請求項1から5のいずれか一項に記載の人工心臓弁。
- 請求項1から6のいずれか一項に記載の人工心臓弁を製造する方法であって、
第1の層の長手方向エッジ部分が第2の層の長手方向エッジ部分を越えて延びるように、前記第1の層を前記第2の層の第1の表面に固定するステップであって、前記第2の層の前記第1の表面はフラシ天表面である、ステップと、
取り付けられた前記第1および第2の層を固定して円筒形状とし、被覆を形成するステップと、
前記被覆を人工心臓弁のフレームの周りに位置させるステップであって、前記フレームは複数の支柱部材を含む、ステップと、
前記第1の層の長手方向エッジ部分を、前記第2の層の長手方向エッジ部分上に折り返して保護部分を形成し、前記保護部分が前記支柱部材の頂点を越えて、前記人工心臓弁の
長手方向軸に沿った方向に延びるようにするステップと、
を含む、方法。 - 前記被覆を前記フレームの周りに位置させるステップは、前記第2の層のフラシ天の第1の表面が半径方向外側に向けられるように、前記被覆を前記フレームの周りに位置させるステップをさらに含む、請求項7に記載の方法。
- 前記保護部分は、前記フレームの流入端部に隣接する流入保護部分であり、
前記流入保護部分の前記第1の層は、第1のストリップ部材として構成され、
前記方法は、前記フレームの流出端部に隣接する流出保護部分を形成するように、第2のストリップ部材の長手方向エッジ部分を、前記第2の層の長手方向エッジ部分上に折り返すステップをさらに含む、請求項7または8に記載の方法。 - 前記第1のストリップ部材の前記長手方向エッジ部分を折り返すステップは、前記流入保護部分が前記フレームの前記流入端部において前記支柱部材のそれぞれの頂点を封入するように前記第1のストリップ部材の前記長手方向エッジ部分を折り返すステップをさらに含み、
前記第2のストリップ部材の前記長手方向エッジ部分を折り返すステップは、前記流出保護部分が前記フレームの前記流出端部において前記支柱部材のそれぞれの頂点を封入するように前記第2のストリップ部材の前記長手方向エッジ部分を折り返すステップをさらに含む、請求項9に記載の方法。 - 前記第2の層は、織物層と、第2の表面を形成する複数のパイル糸を含むフラシ天パイル層とを有する布を含む、請求項7から10のいずれか一項に記載の方法。
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JP2022141328A JP7391158B2 (ja) | 2017-01-23 | 2022-09-06 | 覆われた人工心臓弁 |
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
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US201762449320P | 2017-01-23 | 2017-01-23 | |
US62/449,320 | 2017-01-23 | ||
US201762520703P | 2017-06-16 | 2017-06-16 | |
US62/520,703 | 2017-06-16 | ||
US201762535724P | 2017-07-21 | 2017-07-21 | |
US62/535,724 | 2017-07-21 | ||
US15/876,053 US11185406B2 (en) | 2017-01-23 | 2018-01-19 | Covered prosthetic heart valve |
US15/876,053 | 2018-01-19 | ||
PCT/US2018/014918 WO2018136971A1 (en) | 2017-01-23 | 2018-01-23 | Covered prosthetic heart valve |
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EP3570782A4 (en) | 2019-12-04 |
DK3570782T3 (da) | 2020-10-12 |
SG11201906016YA (en) | 2019-08-27 |
US20180206982A1 (en) | 2018-07-26 |
WO2018136971A1 (en) | 2018-07-26 |
EP4059478A1 (en) | 2022-09-21 |
ES2963207T3 (es) | 2024-03-25 |
CN110167489B (zh) | 2021-12-14 |
HRP20231423T1 (hr) | 2024-03-01 |
EP3570782A1 (en) | 2019-11-27 |
US11185406B2 (en) | 2021-11-30 |
CN114081679A (zh) | 2022-02-25 |
SI4085872T1 (sl) | 2023-12-29 |
JP2022168037A (ja) | 2022-11-04 |
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