JP2014508552A - 人工心臓弁送達システム及びパッケージ - Google Patents
人工心臓弁送達システム及びパッケージ Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
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- B65B55/18—Sterilising contents prior to, or during, packaging by liquids or gases
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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
- A61F2/0095—Packages or dispensers for prostheses or other implants
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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
- A61F2/2415—Manufacturing methods
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/002—Packages specially adapted therefor ; catheter kit packages
-
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- 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
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
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- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
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- Animal Behavior & Ethology (AREA)
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Abstract
Description
本出願は、2010年12月16日に出願された米国仮出願第61/423,785号の35 U.S.C.§119に基づく優先権を主張する。
ガス透過性シールを有する主容器を用意するステップと、
乾燥組織心臓弁及びそれらの送達システムを主容器内に配置して、ガス透過性シールを閉じるステップと、
心臓弁の周囲にガス流通路を形成しつつ主容器内での心臓弁の動きを制限するステップと、
心臓弁と送達システムとを内部に伴うシールされた主容器をガス不透過性材料から成る副容器内に配置し、二重バリアアセンブリを形成するためのガス透過性シールで副容器をシールするステップと、
二重バリアアセンブリをガス系の滅菌に晒すステップと、
ガス不透過性シールを副容器に適用して、酸素又は水が副容器を通過するのを防止するステップと
を備える。
22、142、212 送達システム
40 ホルダ
50 グリップセクション
58 中間セクション
66 先端セクション
76、76' ロッキングヘッド
84 フランジ
102 カプラ
110、200、230、240、250 トレイ
220 ハンドル
262 ラベル
Claims (27)
- 乾燥組織心臓弁及びその送達システムをパッケージングするためのシステムであって、
その弁送達システムに結合される乾燥組織心臓弁と、
その送達システムに結合される前記乾燥組織心臓弁を受けるように寸法付けられ、ガス透過性シールを有する主容器と、
前記主容器を受けるように寸法付けられ、ガス不透過性材料から形成されるとともに、ガス透過性シールとガス不透過性シールとを含む二重シールを有する副容器と、
を備えるシステム。 - 前記主容器が柔軟な袋を構成する請求項1のシステム。
- 前記副容器が柔軟な袋を構成する請求項2のシステム。
- 前記主容器が比較的剛性のトレイを構成する請求項1のシステム。
- 前記副容器が比較的剛性のトレイを構成する請求項4のシステム。
- 前記副容器が柔軟な袋を構成する請求項4のシステム。
- 前記送達システムが収縮可能なハンドルを含む請求項1のシステム。
- 前記収縮可能なハンドルが伸縮セクションを含む請求項7のシステム。
- 前記伸縮セクションが内部ルーメンへ開放するガス流口を含む請求項8のシステム。
- 心臓弁を取り扱うためのシステムにおいて、
人工心臓弁と、
一連の同心的な伸縮セクションを伴う収縮可能なハンドルを有し、前記ハンドルが収縮状態と伸長状態とを有し、前記ハンドルの先端伸縮セクションが先端方向に突出するロッキングヘッドを有する心臓弁送達システムと、
前記人工心臓弁に取り外し可能に固定される弁ホルダであって、基端方向に延びるハンドルカプラを含み、前記ハンドルカプラは、前記人工心臓弁が前記ハンドルの先端伸縮セクションから先端側へ延びるように前記ハンドルの前記ロッキングヘッドと嵌合するように寸法付けられ形成される構造を有する、弁ホルダと
を備えるシステム。 - 前記伸縮セクションは、略管状であるとともに、前記先端伸縮セクションから基端伸縮セクションへと直径が徐々に大きくなる請求項10のシステム。
- 前記伸縮セクションは、いずれか1つのセクションが他のセクション内を完全に通過するのを防止するとともに前記セクションが伸長状態を通り過ぎて外れるのを防止する干渉リップを含む請求項10のシステム。
- 前記伸縮セクション間に摩擦緊密性を与えるために隣接する前記伸縮セクション間に設けられるエラストマーシールを更に含む請求項10のシステム。
- 前記ロッキングヘッドがエラストマーであり、前記ロッキングヘッドと嵌合するように寸法付けられ形成される前記ハンドルカプラの前記構造は、エラストマーの前記ロッキングヘッドが緊密に嵌まり込む内部キャビティを備える請求項10のシステム。
- 基端伸縮セクションを除く伸縮セクションは、外側に向けられたシール部分をその基端部に含み、先端伸縮セクションを除く伸縮セクションは、内側に向けられたリップをその先端部に含むとともに、その先端部から接近して離間される内側に向けられた円形形態部を含み、前記ハンドルを伸長状態へ変換することにより、隣接する伸縮セクションの内側に向けられた前記リップと内側に向けられた前記円形形態部との間の領域で前記各シール部分がロックされる請求項10のシステム。
- 前記人工心臓弁が乾燥組織弁である請求項10のシステム。
- 前記人工心臓弁、前記心臓弁送達システム、及び、前記弁ホルダのための保管容器を更に含み、前記保管容器は、
そのホルダに結合される前記心臓弁と前記ハンドルがその収縮状態を成す前記送達システムとを受けるように寸法付けられ、ガス透過性シールを有する主容器と、
前記主容器を受けるように寸法付けられ、ガス不透過性材料から形成されるとともに、ガス透過性シールとガス不透過性シールとを含む二重シールを有する副容器と
を備える請求項10のシステム。 - 心臓弁を取り扱うための方法において、
弁ホルダに取り外し可能に固定される人工心臓弁を収容する滅菌パッケージを入手するステップであって、前記ホルダが心臓弁送達システムに結合され、前記心臓弁送達システムが一連の同心的な伸縮セクションを伴う収縮可能なハンドルを有し、前記ハンドルが、第1の長さを有する収縮状態と、前記第1の長さよりも相対的に長い第2の長さを有する伸長状態とを有し、前記ハンドルがその収縮状態で前記滅菌パッケージ内に収容される、ステップと、
前記弁、前記ホルダ、及び、前記ハンドルを前記滅菌パッケージから除去するステップと、
前記ハンドルをその収縮状態からその伸長状態へと変換するステップであって、隣接する前記伸縮セクションが互いにロックするまで前記伸縮セクションを引き寄せて前記ハンドルを伸ばすことを含む、ステップと
を含む方法。 - 前記伸縮セクションは、略管状であるとともに、先端伸縮セクションから基端伸縮セクションへと直径が徐々に大きくなり、前記基端伸縮セクションは、ユーザの指を受けるための波状部を伴う人間工学的グリップを有する請求項18の方法。
- 前記伸縮セクションは、いずれか1つのセクションが他のセクション内を完全に通過するのを防止するとともに前記セクションが伸長状態を通り過ぎて外れるのを防止する干渉リップを含む請求項18の方法。
- 前記伸縮セクション間に摩擦緊密性を与えるために隣接する前記伸縮セクション間に設けられるエラストマーシールを更に含む請求項18の方法。
- 基端伸縮セクションを除く伸縮セクションは、外側に向けられたシール部分をその基端部に含み、先端伸縮セクションを除く伸縮セクションは、内側に向けられたリップをその先端部に含むとともに、その先端部から接近して離間される内側に向けられた円形形態部を含み、前記ハンドルを伸長状態へ変換することにより、隣接する伸縮セクションの内側に向けられた前記リップと内側に向けられた前記円形形態部との間の領域で前記各シール部分がロックされる請求項18の方法。
- 前記ハンドルの先端伸縮セクションが先端方向に突出するロッキングヘッドを有し、前記弁ホルダが基端方向に延びるハンドルカプラを含み、前記ハンドルカプラは、前記人工心臓弁が前記ハンドルの先端伸縮セクションから先端側へ延びるように前記ハンドルの前記ロッキングヘッドと嵌合するように寸法付けられ形成される構造を有し、前記ロッキングヘッドがエラストマーであり、前記ロッキングヘッドと嵌合するように寸法付けられ形成される前記ハンドルカプラの前記構造は、エラストマーの前記ロッキングヘッドが緊密に嵌まり込む内部キャビティを備える、請求項18の方法。
- 前記人工心臓弁が乾燥組織弁であり、前記滅菌パッケージが保存液を収容しない請求項18の方法。
- 前記滅菌容器が主容器と副容器とを含み、前記主容器は、ガス透過性シールを有するとともに、その内部の前記心臓弁の周囲にガス流通路を備え、シールされた前記主容器が前記副容器内に配置され、前記副容器は、酸素又は水が前記副容器を通過するのを防止できるガス不透過性シールの内側にガス透過性シールを伴う二重シールを含み、方法は、
前記ガス不透過性シールを前記副容器から除去して、前記滅菌容器をガス系の滅菌に晒すステップと、
前記ガス透過性シールを前記副容器から除去するステップと、
前記ガス透過性シールを前記主容器から除去するステップと、
前記弁、前記ホルダ、及び、前記ハンドルを前記滅菌パッケージから除去する前記ステップを行なうステップと
を更に含む請求項24の方法。 - 前記主容器は、上面と、上縁によって取り囲まれて前記上縁から下方へ降下するキャビティとを有するトレイであり、前記トレイがガス不透過性材料から形成され、前記乾燥組織心臓弁及びその前記送達システムが前記トレイのキャビティ内に配置される請求項25の方法。
- 前記副容器が柔軟な袋を構成する請求項25の方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US42378510P | 2010-12-16 | 2010-12-16 | |
US61/423,785 | 2010-12-16 | ||
US13/324,124 US9498317B2 (en) | 2010-12-16 | 2011-12-13 | Prosthetic heart valve delivery systems and packaging |
US13/324,124 | 2011-12-13 | ||
PCT/US2011/065073 WO2012082986A2 (en) | 2010-12-16 | 2011-12-15 | Prosthetic heart valve delivery systems and packaging |
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JP2016017791A Active JP6338606B2 (ja) | 2010-12-16 | 2016-02-02 | 人工心臓弁送達システム及びパッケージ |
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SG191185A1 (en) | 2013-07-31 |
BR112013015257A2 (pt) | 2021-04-20 |
US20120158128A1 (en) | 2012-06-21 |
BR112013015257B1 (pt) | 2022-03-22 |
EP2651338A4 (en) | 2015-07-15 |
CN103370035B (zh) | 2017-07-14 |
EP2651338A2 (en) | 2013-10-23 |
US11027870B2 (en) | 2021-06-08 |
EP2651338B1 (en) | 2023-06-07 |
JP6338606B2 (ja) | 2018-06-06 |
MX371059B (es) | 2020-01-15 |
CN103370035A (zh) | 2013-10-23 |
WO2012082986A3 (en) | 2012-08-16 |
US9498317B2 (en) | 2016-11-22 |
CA2821423A1 (en) | 2012-06-21 |
US20170073099A1 (en) | 2017-03-16 |
JP2016120307A (ja) | 2016-07-07 |
MX2013006839A (es) | 2013-08-26 |
CA2821423C (en) | 2017-10-24 |
JP5988997B2 (ja) | 2016-09-07 |
WO2012082986A2 (en) | 2012-06-21 |
EP4275735A3 (en) | 2024-01-24 |
MX2019009784A (es) | 2019-10-02 |
EP4275735A2 (en) | 2023-11-15 |
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