JP2009534095A - 皺のない弾性カバーを有する拡張可能なステント - Google Patents
皺のない弾性カバーを有する拡張可能なステント Download PDFInfo
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- JP2009534095A JP2009534095A JP2009506529A JP2009506529A JP2009534095A JP 2009534095 A JP2009534095 A JP 2009534095A JP 2009506529 A JP2009506529 A JP 2009506529A JP 2009506529 A JP2009506529 A JP 2009506529A JP 2009534095 A JP2009534095 A JP 2009534095A
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91508—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a difference in amplitude along the band
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91525—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
- A61F2002/91541—Adjacent bands are arranged out of phase
-
- 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
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
Abstract
Description
倍率を上げて拡大せずに、室温でステント・グラフト装置のカバーを目視で検査した。超小型の装置については顕微鏡による検査を行なうことはいうまでもない。装置の両端を中空のDELRIN(登録商標)アセタール樹脂ブロック内に固定することにより、ステント・グラフトの内面を観察できるように装置の長手軸を水平に対して約45°の角度に固定した。装置の自由縁および装置両端近傍のステント開口部を検査できるように装置を配置した。検査中、完全展開していないステント・グラフトを剛性チューブ内に拘束した。検査に先立って、完全展開させた装置を約37℃の湯浴中に浸漬した。
テーパー形状のマンドレルを利用してステントおよびカバー付きステントの外径を測定した。装置端部がマンドレル周面と嵌合するまでマンドレルに沿って装置端部を摺動させた。次いで、ノギスを使用して装置外径を測定した。上記のようにマンドレルに嵌合させたまま、投影機を使用して装置外径を測定することもできる。
米国特許第6,709,453号明細書の図4に記述されているようなパターンを利用してチューブ状の自己拡張ニチノール・ステントを得た。ステントの外径は約8mm、長さは約30mmであった。ステントに下記のような処理を施した。また、Changほかの米国特許出願第2004/0024448号明細書の例5に開示されているような液化熱可塑フルオロポリマーであるPMVE−TFEの溶液を得た。PMVE−TFEは弾性材料である。比較的希釈度の大きい3質量%のポリマーを利用した。ステントをこのエラストマー溶液に浸漬した。浸漬被覆されたステントを溶液から取り出し、エラストマーが全てのステント開口部に及んでいることを確かめるためチェックし、4時間に亘って自然乾燥させた。
本発明のステント・グラフトを上記態様で製造することの利点は実施例1の装置を公知装置と比較すれば明白である。別のカバー付きステントを上記の通りの態様で、但し、完全展開直径と送達直径との中間的な直径においてステントを圧縮し、エラストマーを再流動化するという本発明のステップを含まない態様で製造した。即ち、比較例としてのカバー付きステントは冷却せず、外径の50%まで圧縮せず、また、弾性カバーを再流動化するために溶剤溶液に浸漬もしなかった。代わりに、周囲条件下で8mmのカバー付きステントを外径の50%まで圧縮し、中空の拘束ブロック内へ移した。比較例としての(公知の)装置は本発明の装置とは異なり、完全展開外径の50%において皺が現れた。
下記相違点を除き、実施例1の記述内容通りにチューブ状の自己拡張ステント・グラフトを製造した。ここでは、皺のないカバーを形成するために実施例1とは異なるステップを採用した。即ち、弾性カバーを形成するためにシリコーン材料(MED−1137 Silicone Adhesive, NuSil Silicone Technology, Carpinteria, CA)を使用した。シリコーンおよびヘプタンのエラストマー溶液をも得た。比較的希釈度の高い1質量%のエラストマー溶液を形成した。ステント、エラストマー溶液、ピンセット、および圧縮装置を、−15℃に設定された公知の冷凍室内で一緒に冷却した。
Claims (7)
- グラフトカバーがステントの少なくとも一部を覆って設けられている自己拡張ステントを備える、直径方向に拡張可能なステント・グラフトであって、前記ステントが、体腔に挿入されるための圧縮直径を有し、かつ解放後に圧縮直径から完全展開直径まで自己拡張し、前記グラフトカバーが完全展開直径の50%〜100%の直径範囲に亘って実質的に皺を有さないことを特徴とする、直径方向に拡張可能なステント・グラフト。
- 前記カバーが弾性材料を含む、請求項1に記載のステント・グラフト。
- 皺のない直径が30%〜100%の範囲に亘る、請求項1に記載のステント・グラフト。
- ステント・グラフト装置の製造方法であって、
完全収縮直径と、完全拡張直径と、完全収縮直径と完全拡張直径の間の中間直径を有するステントを用意し;
中間直径の状態にステントを配向し;
中間直径の状態にあるステント上に弾性カバーを形成してステント・グラフトを形成する
ことを含み;
中間直径から完全拡張直径まで拡張する際にステント・グラフトに実質的に皺がないことを特徴とする、方法。 - 得られたステント・グラフトを収縮させて送達システム内に移すことをさらに含む、請求項4に記載の方法。
- ステント・グラフト装置の製造方法であって、
完全収縮直径と、完全拡張直径と、完全収縮直径と完全拡張直径の間の中間直径を有するステントを用意し;
ステント上に弾性カバーを形成してステント・グラフトを形成し;
中間直径の状態にステントを配向し、この中間直径の状態において実質的に皺がないように弾性カバーを再形成する
ことを含み;
中間直径から完全拡張直径まで拡張する際にステント・グラフトに実質的に皺がないことを特徴とする、方法。 - 得られたステント・グラフトを収縮させて送達システム内に移すことをさらに含む、請求項6に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/408,473 US8721704B2 (en) | 2006-04-21 | 2006-04-21 | Expandable stent with wrinkle-free elastomeric cover |
PCT/US2007/009250 WO2007127082A1 (en) | 2006-04-21 | 2007-04-13 | Expandable stent with wrinkle-free elastomeric cover |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012174981A Division JP5731450B2 (ja) | 2006-04-21 | 2012-08-07 | 皺のない弾性カバーを有する拡張可能なステント |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2009534095A true JP2009534095A (ja) | 2009-09-24 |
Family
ID=38474400
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2009506529A Pending JP2009534095A (ja) | 2006-04-21 | 2007-04-13 | 皺のない弾性カバーを有する拡張可能なステント |
JP2012174981A Active JP5731450B2 (ja) | 2006-04-21 | 2012-08-07 | 皺のない弾性カバーを有する拡張可能なステント |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012174981A Active JP5731450B2 (ja) | 2006-04-21 | 2012-08-07 | 皺のない弾性カバーを有する拡張可能なステント |
Country Status (8)
Country | Link |
---|---|
US (2) | US8721704B2 (ja) |
EP (1) | EP2010097B1 (ja) |
JP (2) | JP2009534095A (ja) |
AT (1) | ATE517588T1 (ja) |
AU (1) | AU2007243559B2 (ja) |
CA (1) | CA2649849C (ja) |
ES (1) | ES2368173T3 (ja) |
WO (1) | WO2007127082A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2019513442A (ja) * | 2016-03-30 | 2019-05-30 | スパイレーション インコーポレイテッド ディー ビー エイ オリンパス レスピラトリー アメリカ | 不規則形状の気道向けの気道弁 |
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US8926688B2 (en) * | 2008-01-11 | 2015-01-06 | W. L. Gore & Assoc. Inc. | Stent having adjacent elements connected by flexible webs |
US10166128B2 (en) | 2011-01-14 | 2019-01-01 | W. L. Gore & Associates. Inc. | Lattice |
US9839540B2 (en) | 2011-01-14 | 2017-12-12 | W. L. Gore & Associates, Inc. | Stent |
US9744033B2 (en) | 2011-04-01 | 2017-08-29 | W.L. Gore & Associates, Inc. | Elastomeric leaflet for prosthetic heart valves |
WO2013019756A2 (en) | 2011-07-29 | 2013-02-07 | Carnegie Mellon University | Artificial valved conduits for cardiac reconstructive procedures and methods for their production |
US9554806B2 (en) | 2011-09-16 | 2017-01-31 | W. L. Gore & Associates, Inc. | Occlusive devices |
CA3051684C (en) | 2011-12-06 | 2020-06-16 | Aortic Innovations Llc | Device for endovascular aortic repair and method of using the same |
US9510935B2 (en) | 2012-01-16 | 2016-12-06 | W. L. Gore & Associates, Inc. | Articles including expanded polytetrafluoroethylene membranes with serpentine fibrils and having a discontinuous fluoropolymer layer thereon |
US9283072B2 (en) | 2012-07-25 | 2016-03-15 | W. L. Gore & Associates, Inc. | Everting transcatheter valve and methods |
US9931193B2 (en) | 2012-11-13 | 2018-04-03 | W. L. Gore & Associates, Inc. | Elastic stent graft |
US9144492B2 (en) | 2012-12-19 | 2015-09-29 | W. L. Gore & Associates, Inc. | Truncated leaflet for prosthetic heart valves, preformed valve |
US9968443B2 (en) | 2012-12-19 | 2018-05-15 | W. L. Gore & Associates, Inc. | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
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ATE517588T1 (de) | 2011-08-15 |
JP5731450B2 (ja) | 2015-06-10 |
ES2368173T3 (es) | 2011-11-15 |
CA2649849A1 (en) | 2007-11-08 |
CA2649849C (en) | 2012-07-10 |
US8721704B2 (en) | 2014-05-13 |
AU2007243559A1 (en) | 2007-11-08 |
AU2007243559B2 (en) | 2011-08-04 |
US20070250146A1 (en) | 2007-10-25 |
WO2007127082A1 (en) | 2007-11-08 |
EP2010097B1 (en) | 2011-07-27 |
JP2013027710A (ja) | 2013-02-07 |
EP2010097A1 (en) | 2009-01-07 |
US20130166016A1 (en) | 2013-06-27 |
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