JP2020501711A - 人工弁用のアンカリングデバイスを送達するための展開システム、ツール、および方法 - Google Patents
人工弁用のアンカリングデバイスを送達するための展開システム、ツール、および方法 Download PDFInfo
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Images
Classifications
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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
- A61F2/02—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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- 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
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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
- A61F2/2418—Scaffolds therefor, e.g. support stents
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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
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- 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
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
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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
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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
- A61F2/2442—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
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- A—HUMAN NECESSITIES
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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
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
本願は、2016年12月16日に出願された「DEPLOYMENT TOOLS AND METHODS FOR DELIVERING AN ANCHORING DEVICE FOR A PROSTHETIC VALVE AT A NATIVE VALVE ANNULUS」と題する米国特許仮出願第62/435,563号に基づく利益を主張するものである。この仮出願は、参照によりその全体が本明細書に組み込まれる。
2 送達デバイス
5 心臓
10a 上方コイル
10b 上方コイル
12 コイル
12a 下方コイル
12b 下方コイル
20 外方シース、ガイドシース、経中隔シース、シース、外方ガイドシース
21 遠位端部部分、遠位端部
24 可撓性送達カテーテル、送達カテーテル
25 可撓性遠位セクション、遠位セクション
26 側部
27 側部
28 頂部
29 底部
30 レーザ切断シート、レーザ切断ファイル
31 側歯
32 側歯
33 上歯
34 側部溝、側部スロット、歯スロット
35 側部溝、側部スロット、歯スロット
36 上部溝、上部スロット
38 リンク
39 スリット
40 歯ライン
50 天然僧帽弁、天然僧帽弁輪
51 左心房
52 左心室
53 後尖、僧帽弁葉
54 前尖、僧帽弁葉
55 心房中隔、中隔
56 右心房
57 下大静脈
58 大動脈
59 三尖弁
60 人工経カテーテル心臓弁、THV
61 右心室
62 線維索、腱索、腱
63 大動脈弁
64 送達カテーテル、送達デバイス
65 遠位セクション、遠位端部
66 軽度湾曲部分
67 円形または湾曲状の平坦部分、円形/湾曲状平坦部分、平坦部分
68 巻線部
69 可撓性端部部分、可撓性端部
70 第1の作動ポイント
71 第2の作動ポイント
Claims (28)
- 患者の心臓の天然弁までアンカリングデバイスを送達するための送達カテーテルであって、前記アンカリングデバイスが前記天然弁にてプロテーゼを固定するように構成された、送達カテーテルにおいて、
第1の端部を有する近位部分、第2の端部を有する遠位部分、および前記アンカリングデバイスを通過させるようにサイズ設定された前記第1の端部と前記第2の端部との間に延在するボアを備える可撓性チューブであって、前記遠位部分は、第1の曲げセクションおよび第2の曲げセクションを備える、可撓性チューブと、
前記可撓性チューブ内に少なくとも部分的に配設された第1のプルワイヤと、
前記可撓性チューブ内に少なくとも部分的に配設された第2のプルワイヤと
を備え、
前記第1のプルワイヤおよび前記第2のプルワイヤの作動により、前記可撓性チューブが第1の構成から第2の構成へと動かされ、
前記可撓性チューブが前記第2の構成にある場合に、前記第1の曲げセクションは第1の湾曲部分を形成し、前記第2の曲げセクションは湾曲平坦部分を形成する、送達カテーテル。 - 第1のリングおよび第2のリングをさらに備え、前記第1のリングは第1の作動ポイントに配設され、前記第1のプルワイヤは前記第1のリングに対して装着され、前記第2のリングは第2の作動ポイントに配設され、前記第2のプルワイヤは前記第2のリングに対して装着される、請求項1に記載の送達カテーテル。
- 前記近位部分と前記第2のリングとの間に配設された第3のリングと、前記第1のリングと前記第2のリングとの間に配設された第1のスパインと、前記第2のリングと前記第3のリングとの間に配設された第2のスパインとをさらに備える、請求項2に記載の送達カテーテル。
- 前記第1のスパインは、前記可撓性チューブが前記第2の構成へと動かされる場合に、前記第1のリングと前記第2のリングとの間における圧縮動を制限するように構成される、請求項3に記載の送達カテーテル。
- 前記第2のスパインは、前記可撓性チューブが前記第2の構成へと動かされる場合に、前記第2のリングと前記第3のリングとの間における前記第1のプルワイヤによる屈曲を制限するように構成される、請求項4に記載の送達カテーテル。
- 前記第1の曲げセクションは、前記第1のリングと前記第2のリングとの間に延在し、前記第2の曲げセクションは、前記第2のリングと前記第3のリングとの間に延在する、請求項3から5のいずれか一項に記載の送達カテーテル。
- 前記第1のスパインのショアD硬度と前記第2のスパインのショアD硬度との比率が、約1.5:1〜約6:1の間である、請求項3から6のいずれか一項に記載の送達カテーテル。
- 前記可撓性チューブはニチノールを含む、請求項1から7のいずれか一項に記載の送達カテーテル。
- 前記可撓性チューブはプラスチックを含む、請求項1から7のいずれか一項に記載の送達カテーテル。
- 前記第1のスパインおよび前記第2のスパインはステンレス鋼を含む、請求項3から7のいずれか一項に記載の送達カテーテル。
- 前記第1のスパインおよび前記第2のスパインはプラスチックを含む、請求項3から7のいずれか一項に記載の送達カテーテル。
- 前記可撓性チューブは堅いチューブである、請求項1から11のいずれか一項に記載の送達カテーテル。
- 前記可撓性チューブが前記第2の構成にある場合に、前記可撓性チューブの前記略湾曲平坦部分は、主要部分および可撓性端部部分を備え、前記可撓性端部部分は、展開のための前記アンカリングデバイスの位置決めを支援するように曲がるように構成される、請求項1から12のいずれか一項に記載の送達カテーテル。
- 前記可撓性端部部分は、前記湾曲平坦部分の前記主要部分に対して角度をつけられるように構成される、請求項13に記載の送達カテーテル。
- 前記可撓性端部部分と前記主要部分との間の垂直変位が、約2mm〜約10mmの間である、請求項14に記載の送達カテーテル。
- 前記第1のプルワイヤの少なくとも一部分の周囲に延在する第1のコイル状スリーブと、前記第2のプルワイヤの少なくとも一部分の周囲に延在する第2のコイル状スリーブとをさらに備える、請求項1から15のいずれか一項に記載の送達カテーテル。
- 前記第1の作動ポイントは、約65度〜約115度だけ前記第2の作動ポイントから周方向にオフセットされる、請求項2から16のいずれか一項に記載の送達カテーテル。
- 前記第1の作動ポイントは、約90度だけ前記第2の作動ポイントから周方向にオフセットされる、請求項2から17のいずれか一項に記載の送達カテーテル。
- 患者の心臓の天然弁までアンカリングデバイスを送達するために送達カテーテルを使用する方法であって、
前記心臓の心腔内に前記送達カテーテルを前進させるステップと、
前記送達カテーテルの第1の曲げセクションに第1の湾曲部分を形成するステップと、
前記送達カテーテルの第2の曲げセクションに湾曲平坦部分を形成するステップと、
前記天然弁の交連の方向に前記アンカリングデバイスを送達するために前記送達カテーテルの遠位開口を位置決めするステップと、
前記カテーテルを通して前記天然弁まで前記アンカリングデバイスを送達するステップと
を含む、方法。 - 前記送達カテーテルの少なくとも一部分が前記天然弁の弁輪の平面に対して略平行になるように、前記送達カテーテルの前記遠位開口の高さまたは角度の少なくとも一方を調節するステップをさらに含む、請求項19に記載の方法。
- 前記天然弁の前記交連を貫通して前記心臓の心室の第2の心腔内に前記送達カテーテルの前記遠位開口の少なくとも一部を前進させるステップをさらに含む、請求項19または20に記載の方法。
- 前記天然弁の前記交連は、僧帽弁の交連A3P3である、請求項19から21のいずれか一項に記載の方法。
- 前記心腔は、左心房であり、前記送達カテーテルは、右心房から心房中隔を経由して左心房内に前進される、請求項19から22のいずれか一項に記載の方法。
- 患者の心臓の天然弁輪までアンカリングデバイスを送達するために送達カテーテルを使用する方法であって、前記アンカリングデバイスは、前記天然弁輪にプロテーゼを固定するように構成される、方法において、
前記心臓まで前記送達カテーテルを前進させるステップと、
前記送達カテーテルの遠位開口が前記天然弁の交連の付近に位置決めされるように、前記天然弁輪の周囲に少なくとも部分的に前記送達カテーテルを曲げるステップと、
前記送達カテーテルの少なくとも一部分が前記天然弁輪を含む平面に対して実質的に平行になるように、前記送達カテーテルの延長部の高さまたは角度の少なくとも一方を調節するステップと
を含む、方法。 - 前記天然弁輪は、僧帽弁輪であり、前記天然弁の前記交連は、僧帽弁の交連A3P3である、請求項24に記載の方法。
- 交連A3P3を貫通して左心室内に前記送達カテーテルの少なくとも一部を前進させるステップをさらに含む、請求項25に記載の方法。
- 前記送達カテーテルは、前記遠位開口が前記天然弁輪に向けられるような角度で前記心臓の心腔に進入するように構成され、前記送達カテーテルの延長部の高さまたは角度の少なくとも一方を調節する前記ステップは、第1の曲げ部に対して遠位に位置する前記送達カテーテルの少なくとも一部分を、前記天然弁輪を含む平面に対して略平行に配置させるように、前記第1の曲げ部を形成するステップを含む、請求項24から26のいずれか一項に記載の方法。
- 前記第1の曲げ部と前記遠位開口との間の前記送達カテーテルの領域が、前記天然弁の前記交連に向かってさらに角度をつけられるまたは下方に向けられる、請求項27に記載の方法。
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AU2017378495A1 (en) | 2019-05-23 |
EP3554424B1 (en) | 2022-12-28 |
CN113288514A (zh) | 2021-08-24 |
WO2018112429A1 (en) | 2018-06-21 |
PL3554424T3 (pl) | 2023-05-08 |
JP7440263B2 (ja) | 2024-02-28 |
EP3554424A1 (en) | 2019-10-23 |
US11382744B2 (en) | 2022-07-12 |
EP4218672A1 (en) | 2023-08-02 |
CN110072492A (zh) | 2019-07-30 |
JP2023159316A (ja) | 2023-10-31 |
FI3554424T3 (fi) | 2023-03-30 |
PT3554424T (pt) | 2023-04-03 |
CN110072492B (zh) | 2021-06-11 |
US20190070003A1 (en) | 2019-03-07 |
HUE061376T2 (hu) | 2023-06-28 |
US20180318079A1 (en) | 2018-11-08 |
EP3554424A4 (en) | 2020-01-01 |
US10940000B2 (en) | 2021-03-09 |
CA3046974A1 (en) | 2018-06-21 |
JP2024057066A (ja) | 2024-04-23 |
JP2023022180A (ja) | 2023-02-14 |
CR20190219A (es) | 2019-09-30 |
SI3554424T1 (sl) | 2023-04-28 |
AU2023200645A1 (en) | 2023-03-09 |
ES2941260T3 (es) | 2023-05-19 |
JP7447226B2 (ja) | 2024-03-11 |
US20220331101A1 (en) | 2022-10-20 |
AU2017378495B2 (en) | 2022-11-24 |
DK3554424T3 (da) | 2023-03-13 |
HRP20230241T1 (hr) | 2023-04-14 |
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