JP2012522606A - 改良型胃内空間充填物および生体外試験を含む製造方法 - Google Patents
改良型胃内空間充填物および生体外試験を含む製造方法 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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0036—Intragastrical devices
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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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/003—Implantable devices or invasive measures inflatable
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C53/00—Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
- B29C53/36—Bending and joining, e.g. for making hollow articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D22/00—Producing hollow articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2022/00—Hollow articles
- B29L2022/005—Hollow articles having dividing walls, e.g. additional elements placed between object parts
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
- Y10T156/1005—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina by inward collapsing of portion of hollow body
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
- Y10T156/10—Methods of surface bonding and/or assembly therefor
- Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
- Y10T156/1036—Bending of one piece blank and joining edges to form article
- Y10T156/1038—Hollow cylinder article
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Obesity (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Child & Adolescent Psychology (AREA)
- Nursing (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
本願は、米国仮特許出願第61/166,675号(2009年4月3日出願)の利益および優先権を主張し、この出願の内容は、その全体が本明細書において完全に記述されるがごとく参照により組込まれる。
Claims (43)
- 胃内デバイスを製造するプロセスであって、
本体、該本体から延在するカフ、および該カフの端部にあるカラーを有するバルーンを提供することと、
該バルーンの該カフおよび該カラーを通るシャフトを提供することと、
該バルーンの該本体内において、該カフを自身の上に折り畳むことであって、それにより、該カフは該バルーンの該本体まで連行され、および該カフは重複した表面および折り畳まれた内面を形成する、ことと、
バルーンとバルーンとの界面において、該カフの該重複した表面を相互に接着させることと、
バルーンとシャフトとの界面において、該折り畳まれた内面を該シャフトに接着させることと
を組み合わせて含む、プロセス。 - 前記重複した表面は、シリコーン系接着剤によって相互に接着させられる、請求項1に記載のプロセス。
- 前記接着剤は、前記バルーンの硬度とほぼ同じ硬度を有する、請求項2に記載のプロセス。
- 前記折り畳まれた内面は、シリコーン系接着剤によって前記シャフトに接着させられる、請求項1に記載のプロセス。
- 前記接着剤は、前記シャフトの硬度より低い硬度を有する、請求項4に記載のプロセス。
- 請求項1に記載されるプロセスによる製品。
- 胃内空間充填物を製造する改良型プロセスであって、
バルーン、および該バルーンを通って延在するシャフトを有する胃内デバイスを提供することであって、該シャフトは、該バルーンに固定され、該バルーンおよび該シャフトは、該バルーンの露出面部分が該シャフトの露出面部分と接触する、バルーンからシャフトへの移行部を形成する、ことと、
少なくとも該バルーンからシャフトへの移行部にわたって表面フィレットを提供することと
を組み合わせて含む、改良型プロセス。 - 前記表面フィレットは、接着剤によって接合されるシートである、請求項7に記載のプロセス。
- 前記シートは、前記シャフトと同心のワッシャを形成する、請求項8に記載のプロセス。
- 前記表面フィレットは接着剤である、請求項7に記載のプロセス。
- 前記表面フィレットはシリコーン系である、請求項7に記載のプロセス。
- 前記表面フィレットは、前記シャフトの硬度と前記バルーンの硬度との間の硬度を有する、請求項7に記載のプロセス。
- 前記表面フィレットは、前記移行部付近の応力集中を低減して、バルーンからシャフトへのより円滑な移行を促進する、請求項7に記載のプロセス。
- 少なくとも第2のバルーンからシャフトへの移行部にわたって、第2の表面フィレットを提供することをさらに含む、請求項7に記載のプロセス。
- 請求項7に記載されるプロセスによる製品。
- シャフトと、
本体および2つのカフを有するバルーンであって、各カフは自身の端部にカラーを有し、該カフは、組み立てた状態にある間、該バルーンの該2つのカフおよび本体を通してシャフトを受容するように構成され、該シャフトおよびバルーンは、該組み立てた状態にある間、該バルーンの露出面部分が該シャフトの露出面部分と接触する、少なくとも1つのバルーンからシャフトへの移行部を形成する、バルーンと、
組み立てた状態にある間、該バルーンからシャフトへの移行部にわたって配置されるように構成される表面フィレットであって、該表面フィレットは、該バルーンからシャフトへの移行部付近の応力集中を低減して、バルーンからシャフトへのより円滑な移行を促進する、表面フィレットと
を組み合わせて備える、キット。 - 前記バルーン、前記シャフト、および前記表面フィレットは、前記組み立てた状態にある、請求項16に記載のキット。
- 最大で約55Aのショアデュロメータ硬度を有するシャフトと、
少なくとも約20Aのショアデュロメータ硬度を有し、本体、該本体から延在するカフ、および該カフの端部にあるカラーを備えるバルーンと、
バルーンからシャフトへの移行部における該バルーンの露出面部分および該シャフトの露出面部分にわたる表面フィレットであって、該シャフトの硬度と該バルーンの硬度との間の硬度を有する、表面フィレットと
を組み合わせて備える、胃内デバイス。 - 前記表面フィレットは、接着剤によって接合されるシートである、請求項18に記載の胃内デバイス。
- 前記シートは、前記シャフトと同心のワッシャを形成する、請求項18に記載の胃内デバイス。
- 前記表面フィレットは、接着剤である、請求項18に記載の胃内デバイス。
- シャフトと、
本体、該本体から延在するカフ、および該カフの端部にあるカラーを備えるバルーンと
を組み合わせて備え、
該本体の内側部分は、内部フィレットを有し、該内部フィレットは、該バルーンの赤道の厚さよりも大きい厚さを有し、および該バルーンの該本体内において折り畳まれるときに、該バルーンの内壁を、該シャフトおよび該カフのうちの少なくとも1つまで移行させるように構成される、胃内デバイス。 - 胃の中の状態の加速シミュレーションのための生体外試験プロセスであって、
胃内デバイスをアセトン槽に提供することと、
該胃内デバイスの膨張を誘発することと、
該胃内デバイスにおける弱点を悪化させることと
の組み合わせて含む、生体外試験プロセス。 - 結果を観察することをさらに含む、請求項23に記載のプロセス。
- 生体内試験の結果を推定することをさらに含む、請求項23に記載のプロセス。
- 前記膨張は、前記胃内デバイスの透過性に比例して誘発される、請求項23に記載のプロセス。
- 前記アセトン槽は、容量で少なくとも約95%のアセトンを含有する、請求項23に記載のプロセス。
- 前記アセトン槽は、室温において提供される、請求項23に記載のプロセス。
- 前記胃内デバイスおよび前記アセトン槽は、密閉環境内で維持される、請求項23に記載のプロセス。
- 前記生体外試験プロセスにおける前記胃内デバイスの故障までの時間は、生体内試験における故障までの予測時間と線形関係にある、請求項23に記載のプロセス。
- 胃の中の状態の加速シミュレーションのための生体外試験プロセスであって、
約1.0と約1.5との間のpHであって、約50℃と約60℃との間に加熱される塩酸槽に胃内デバイスを提供することと、
該胃内デバイスにおける弱点を悪化させることと
の組み合わせて含む、生体外試験プロセス。 - 結果を観察することをさらに含む、請求項31に記載のプロセス。
- 生体内試験の結果を推定することをさらに含む、請求項31に記載のプロセス。
- 胃内デバイスのバルーンを製造するプロセスであって、
該バルーン用の材料を加熱環境に曝すことであって、それにより、該バルーンに対する標的特性の約85%と約95%との間のものが、部分的架橋結合によって達成される、ことと、
該加熱環境から該バルーンを除去することであって、それにより、付加的な架橋結合が、該加熱環境から維持される残留熱によって達成および推進される、ことと、
該バルーンを放射線に基づく減菌に曝すことであって、それにより、該標的特性の約100%が達成される、ことと
を組み合わせて含む、プロセス。 - 前記標的特性は、機械的応力を受けるときの故障に対する耐性である、請求項34に記載のプロセス。
- 前記標的特性は、機械的応力を受けるときの故障に対する耐性である、請求項34に記載のプロセス。
- 前記機械的応力は、トルクである、請求項36に記載のプロセス。
- 前記機械的応力は、伸びである、請求項36に記載のプロセス。
- 前記標的特性は、引張強度である、請求項34に記載のプロセス。
- 前記標的特性は、前記バルーンの壁を横断する進入および退出に対する耐性である、請求項34に記載のプロセス。
- 前記バルーン用の材料は、シリコーン系である、請求項34に記載のプロセス。
- 前記放射線に基づく減菌は、ガンマ線減菌である、請求項34に記載のプロセス。
- 請求項34に記載されるプロセスによる製品。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16667509P | 2009-04-03 | 2009-04-03 | |
US61/166,675 | 2009-04-03 | ||
PCT/US2010/029865 WO2010115161A2 (en) | 2009-04-03 | 2010-04-02 | Improved intragastric space fillers and methods of manufacturing including in vitro testing |
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JP2014133561A Division JP5735685B2 (ja) | 2009-04-03 | 2014-06-30 | 改良型胃内空間充填物および生体外試験を含む製造方法 |
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JP2012522606A true JP2012522606A (ja) | 2012-09-27 |
JP5670424B2 JP5670424B2 (ja) | 2015-02-18 |
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JP2012503759A Expired - Fee Related JP5670424B2 (ja) | 2009-04-03 | 2010-04-02 | 改良型胃内空間充填物および生体外試験を含む製造方法 |
JP2014133561A Expired - Fee Related JP5735685B2 (ja) | 2009-04-03 | 2014-06-30 | 改良型胃内空間充填物および生体外試験を含む製造方法 |
JP2015084207A Withdrawn JP2015134229A (ja) | 2009-04-03 | 2015-04-16 | 改良型胃内空間充填物および生体外試験を含む製造方法 |
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JP2015084207A Withdrawn JP2015134229A (ja) | 2009-04-03 | 2015-04-16 | 改良型胃内空間充填物および生体外試験を含む製造方法 |
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US (3) | US8683881B2 (ja) |
EP (1) | EP2414025A4 (ja) |
JP (3) | JP5670424B2 (ja) |
CA (1) | CA2757547A1 (ja) |
WO (1) | WO2010115161A2 (ja) |
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US8683881B2 (en) | 2014-04-01 |
US20140371775A1 (en) | 2014-12-18 |
WO2010115161A3 (en) | 2011-03-03 |
JP2014184336A (ja) | 2014-10-02 |
US20100251837A1 (en) | 2010-10-07 |
WO2010115161A2 (en) | 2010-10-07 |
JP5735685B2 (ja) | 2015-06-17 |
JP2015134229A (ja) | 2015-07-27 |
EP2414025A2 (en) | 2012-02-08 |
EP2414025A4 (en) | 2017-08-02 |
US8840952B2 (en) | 2014-09-23 |
US20100256667A1 (en) | 2010-10-07 |
CA2757547A1 (en) | 2010-10-07 |
JP5670424B2 (ja) | 2015-02-18 |
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