JP2016518155A - 左心耳に空置術を行うためのデバイスおよび方法 - Google Patents
左心耳に空置術を行うためのデバイスおよび方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12159—Solid plugs; being solid before insertion
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A61B2017/00495—Surgical glue applicators for two-component glue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
- A61B2017/22047—Means for immobilising the guide wire in the patient
- A61B2017/22048—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
Abstract
Description
本出願は、米国特許法第119条(e)項に基づき2013年3月13日に出願された米国特許仮出願第61/779,802号の優先権の利益を主張するものである。この仮出願の全体が、参照により本明細書に組み込まれる。
102 左心耳
104 左心房
106 左心室
110 心門
200 左心耳
202 左心房
204 閉塞デバイスまたはプラグ
206 高強度薄層
208 発泡プラグ
210 放射線不透過性糸
212 中心ルーメン
214 通路
216 遠位クリンプ
300 発泡プラグ
302 糸
304 クリンプ
400 プラグ
404 ワイヤ
406 左心耳
408 スクリューワイヤ
410 中心ルーメン
502 ねじ
504 左心耳壁
506 心外膜表面
600 発泡プラグ
602 左心房面
604 ePTFE材料
606 管状クリンプ
608 内方チューブ
610 左心耳面
804 左心耳心門
900 ガイドカテーテル
902 ガイドワイヤ
904 左心耳
1002 ガイドワイヤ
1006 バルーン
1100 ガイドカテーテル
1102 放射線不透過性マーカ
1104 左心耳
1108 ガイドワイヤ
1200 ガイドカテーテル
1202 プッシャー
1204 発泡プラグ
1210 ガイドワイヤ
1300 ガイドカテーテル
1400 ガイドカテーテル
1404 発泡プラグ
1408 遠位バルーン
1412 シャフト
1508 ガイドワイヤバルーン
1514 接着剤
1600 発泡体
1602 金属ステント
1606 穴
1608 近位尖部
1610 遠位尖部
1700 発泡プラグ
1702 ワイヤコイル
1704 空洞部
1706 近位端部
1800 ばね状インプラントワイヤ
1802 発泡体
1902 遠位クリンプ要素
2000 プラグ
2002 中心チューブ
2004 カバー
2100 プラグ
2102 ガイドカテーテル
2104 チューブ
2106 プラグ
2202 発泡体材料
2204 ガイドカテーテル
2206 プランジャ
2210 円盤形状
2220 シリンダ
2302 小型返し
2400 回収縫合糸
2402 近位キャップ
2404 ガイドカテーテル
2500 発泡プラグ
2502 遠位ねじリード
2504 ガイドワイヤ
2506 ガイド
2508 バードネスト
2510 プッシャー
2600 発泡プラグ
2602 返し付きリード
2604 返し、返し付きリード
Claims (28)
- 左心耳閉塞デバイスであって、
左心耳内への植込み後に左心房に対面するための近位端部、植込み後に前記左心耳内に対面するための遠位端部、および側壁部を有する拡張可能連続気泡発泡体と、
前記発泡体の少なくとも前記近位端部を覆うスキンと、
前記発泡体を貫通して延在するガイドワイヤルーメンと、
を備え、
前記発泡体は、約20F未満の内径を有する送達カテーテル内に圧縮され得るものであり、前記送達カテーテルから解放された場合に少なくとも約25mmの直径へと自動拡張し得ることを特徴とする左心耳閉塞デバイス。 - 前記スキンはePTFEを含む、請求項1に記載の左心耳閉塞デバイス。
- 前記スキンは、前記遠位端部まで前記ガイドワイヤルーメンの長さにわたって延在する、請求項1に記載の左心耳閉塞デバイス。
- 前記スキンは、前記発泡体の前記遠位端部の少なくとも一部分をさらに覆う、請求項3に記載の左心耳閉塞デバイス。
- 前記発泡体の前記側壁部上に少なくとも1つの組織内部成長表面を備える、請求項1に記載の左心耳閉塞デバイス。
- 前記組織内部成長表面は、前記スキンにより覆われない前記発泡体の露出表面を備える、請求項5に記載の左心耳閉塞デバイス。
- 前記組織内部成長表面は、前記発泡体の前記側壁部の表面領域の少なくとも約20%を含む、請求項6に記載の左心耳閉塞デバイス。
- 前記スキンは、第1の端部および第2の端部を有する管状スリーブを備え、前記スリーブは、前記ガイドワイヤルーメンを貫通して延在し、前記発泡体を越えてめくれ返り、それにより前記第1の端部および前記第2の端部は、相互に連結されて前記発泡体を囲む、請求項1に記載の左心耳閉塞デバイス。
- 前記第1の端部および前記第2の端部は、クリンプにより相互に連結される、請求項8に記載の左心耳閉塞デバイス。
- 少なくとも1つの放射線不透過性マーカをさらに備える、請求項1に記載の左心耳閉塞デバイス。
- 前記放射線不透過性マーカは放射線不透過性糸を備える、請求項10に記載の左心耳閉塞デバイス。
- 前記発泡体内への組織内部成長を可能にするために前記スキン内に複数の開口を備える、請求項8に記載の左心耳閉塞デバイス。
- 前記デバイスは、非拘束拡張状態で実質的に円筒状の構成を備える、請求項1に記載の左心耳閉塞デバイス。
- 少なくとも1つのアンカーをさらに備える、請求項1に記載の左心耳閉塞デバイス。
- 前記アンカーは組織貫通要素を備える、請求項14に記載の左心耳閉塞デバイス。
- 前記組織貫通要素はらせん状ワイヤを備える、請求項15に記載の左心耳閉塞デバイス。
- 左心耳閉鎖システムであって、
近位端部および遠位端部、ならびに貫通して延在する少なくとも1つのルーメンを有する細長可撓性管状体を備える送達カテーテルと、
少なくとも一部分を覆うスキンおよび貫通して延在するガイドワイヤを備える、前記送達カテーテルの前記遠位端部内に圧縮される自動拡張可能連続気泡発泡体と、
前記閉鎖システムの遠位端部から前記発泡体を展開するために前記ルーメンを貫通して延在する軸方向可動展開制御装置と、
を備えることを特徴とする左心耳閉鎖システム。 - 膨張可能バルーンを有するガイドワイヤをさらに備える、請求項17に記載の左心耳閉鎖システム。
- 前記発泡体の少なくとも一部分を覆うスキンをさらに備える、請求項17に記載の左心耳閉鎖システム。
- 前記発泡体内への組織内部成長を可能にするために前記スキンに貫通する少なくとも1つの開口をさらに備える、請求項19に記載の左心耳閉鎖システム。
- 前記管状体を貫通して延在する第2のルーメンをさらに備える、請求項17に記載の左心耳閉鎖システム。
- 前記第2のルーメンは、前記発泡体の表面に流動性媒体を送達するように構成される、請求項21に記載の左心耳閉鎖システム。
- 前記流動性媒体は接着剤を含む、請求項22に記載の左心耳閉鎖システム。
- 左心耳に空置術を行う方法であって、
近位端部および遠位端部を有する細長管状体を有する送達カテーテルを用意するステップと、
前記左心耳内にガイドワイヤを前進させるステップと、
前記ガイドワイヤ上を前記左心耳内に前記遠位端部を前進させるステップと、
前記遠位端部からインプラントを展開させるステップと
を含み、
前記インプラントは、連続気泡発泡体および外方層を有する自動拡張本体を備え、前記インプラントは、前記左心耳の表面に形状合致する、左心耳に空置術を行う方法。 - インプラントを展開する前記ステップの前に前記ワイヤ上のバルーンを膨張させるステップをさらに含む、請求項24に記載の左心耳に空置術を行う方法。
- 隣接する組織に前記インプラントを固定するステップをさらに含む、請求項24に記載の左心耳に空置術を行う方法。
- 固定する前記ステップは、隣接する組織に前記インプラントを接着結合するステップを含む、請求項26に記載の左心耳に空置術を行う方法。
- 固定する前記ステップは、前記隣接する組織に機械的に係合するステップを含む、請求項26に記載の左心耳に空置術を行う方法。
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US201361779802P | 2013-03-13 | 2013-03-13 | |
US61/779,802 | 2013-03-13 | ||
PCT/US2014/022865 WO2014164572A1 (en) | 2013-03-13 | 2014-03-10 | Devices and methods for excluding the left atrial appendage |
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JP2016518155A true JP2016518155A (ja) | 2016-06-23 |
JP2016518155A5 JP2016518155A5 (ja) | 2017-11-09 |
JP6423851B2 JP6423851B2 (ja) | 2018-11-14 |
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JP2020536656A (ja) * | 2017-10-10 | 2020-12-17 | ザ テキサス エーアンドエム ユニバーシティ システムThe Texas A&M University System | シース型塞栓形成装置 |
JP2022115990A (ja) * | 2016-10-27 | 2022-08-09 | コンフォーマル・メディカル・インコーポレイテッド | 左心耳を排除するためのデバイスおよび方法 |
US11717303B2 (en) | 2013-03-13 | 2023-08-08 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11890020B2 (en) | 2017-02-23 | 2024-02-06 | DePuy Synthes Products, Inc. | Intrasaccular aneurysm treatment device with varying coatings |
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US11399842B2 (en) | 2013-03-13 | 2022-08-02 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US10617425B2 (en) | 2014-03-10 | 2020-04-14 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
WO2015152741A1 (en) | 2014-03-31 | 2015-10-08 | Jitmed Sp. Z.O.O. | Left atrial appendage occlusion device |
EP4299019A3 (en) * | 2015-04-01 | 2024-03-06 | Boston Scientific Scimed, Inc. | Systems for delivery of gel embolics |
EP3322353B1 (en) * | 2015-07-13 | 2023-01-11 | Marvel Medical Technologies LLC | Device for left atrial appendage closure |
US20170035433A1 (en) | 2015-08-06 | 2017-02-09 | Thomas J. Forbes | Left atrial appendage occluder device anchoring system, anchor, and method of attachment |
EP3340890B1 (en) * | 2015-08-25 | 2022-07-06 | University Of Louisville Research Foundation, Inc. | Atrial appendage closure device |
JP6899832B2 (ja) * | 2015-10-12 | 2021-07-07 | コンフォーマル・メディカル・インコーポレイテッド | 左心耳を排除するためのデバイスおよび方法 |
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US20180000490A1 (en) | 2018-01-04 |
US20140277074A1 (en) | 2014-09-18 |
EP2968878B1 (en) | 2020-08-12 |
US11717303B2 (en) | 2023-08-08 |
WO2014164572A1 (en) | 2014-10-09 |
EP2968878A1 (en) | 2016-01-20 |
CN105246540A (zh) | 2016-01-13 |
US20240074766A1 (en) | 2024-03-07 |
EP2968878A4 (en) | 2016-11-02 |
US9943315B2 (en) | 2018-04-17 |
JP6423851B2 (ja) | 2018-11-14 |
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