JP2010505597A - ポリホスファゼンを用いたバイオ人工心臓弁 - Google Patents
ポリホスファゼンを用いたバイオ人工心臓弁 Download PDFInfo
- Publication number
- JP2010505597A JP2010505597A JP2009532558A JP2009532558A JP2010505597A JP 2010505597 A JP2010505597 A JP 2010505597A JP 2009532558 A JP2009532558 A JP 2009532558A JP 2009532558 A JP2009532558 A JP 2009532558A JP 2010505597 A JP2010505597 A JP 2010505597A
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- JP
- Japan
- Prior art keywords
- polyphosphazene
- heart valve
- phosphazene
- mammalian
- trifluoroethoxy
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 125000003652 trifluoroethoxy group Chemical group FC(CO*)(F)F 0.000 claims abstract description 32
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- 238000000576 coating method Methods 0.000 claims description 13
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Abstract
【選択図】 図5
Description
哺乳動物心臓弁を提供する工程と;および
上記哺乳動物心臓弁をポリ[ビス(トリフルオロエトキシ)ホスファゼン]と接触させる工程を含み、
このとき上記ポリ[ビス(トリフルオロエトキシ)ホスファゼン]は、上記哺乳動物心臓弁内もしくは上にコーティングされる、拡散させられる、含浸させられる、グラフト化される、またはそれらの任意の組み合わせが実施される方法を提供する。
心臓弁は、ヒトもしくは他の哺乳動物から摘出され、処理する前に脱水剤/溶媒中ですすぎ洗いする。すすぎ洗いした心臓弁は、次にアミン、ポリアミン、アミノシランなどの固定剤と接触させる工程によって前処理する。前処理した心臓弁は、次にアセトンもしくはTHF溶媒中のポリ[ビス(トリフルオロエトキシ)ホスファゼン]ポリマーの溶液中へ浸漬させ、その後に処理した弁を乾燥させる。このコーティング工程後、処理した弁を再び水化し、栄養溶液もしくは食塩溶液中に貯蔵し、さらに状態調節し、滅菌し、保存し、そしてバイオ人工インプラントとして利用される任意の移植片タイプの心臓弁の使用にしたがった様式で使用する。
約10×106g/mol〜約2×107g/molの平均分子量を有するポリ[ビス(トリフルオロエトキシ)ホスファゼン]ポリマーは、米国特許出願公開第2003/0157142号明細書にしたがって調製する。ポリホスファゼンを約0.1%〜約99%の濃度で含有するポリ[ビス(トリフルオロエトキシ)ホスファゼン]の溶液は、例えばホルムアルデヒドもしくはグルタルアルデヒドなどの固定剤および界面活性剤と一緒に、メチルエチルケトンなどの溶媒中で調製する。界面活性剤は、本明細書に開示したようなポリソルベートもしくはポロキサマー、ポリエチレンイミン、もしくはポリアリルアミンなどから選択できる。または、ホルムアルデヒドもしくはグルタルアルデヒドは、本明細書に記載したように追加の溶媒の必要を伴わずに溶媒および固定剤として機能できる。さらにまたは、溶媒もしくは固定剤のいずれかは、追加の界面活性剤の必要を伴わずに、界面活性剤として機能することもできる。
真ちゅう体、ミニガス流量調節器を用いて閉鎖され、約250mL/150gのジメチルエーテルを含有する加圧式容器、例えばレクチャーボトル、加圧缶(pressure tin)もしくはオートクレーブを、固体CO2/エタノール冷却浴(または、液体N2浴)を用いて外部からその沸点(−23℃)未満だがその融点(−138.5℃)よりは高い温度へ冷却する。適正な安全注意事項(保護スクリーン/シールド、換気)の下で、ガス流量調節器を弁を緩徐に開放することによって内圧が大気圧へ均等化された後に開放し、その後に調節器を取り外す。ポリ[ビス(トリフルオロエトキシ)ホスファゼン]ポリマーの固体サンプル、1.25g(0.5%(w/v))を容器の内容物へ迅速に加え、加圧式容器をその後気密性で密封する。ポリホスファゼンサンプルを、次に、加圧ボトルの内容物を攪拌するために水平攪拌器を用いて、室温で24時間にわたってジメチルエーテル中に溶解させる。
例1〜3のいずれかによって、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]ポリマーを調製し、図2に示したようなヒト移植片タイプ(ホモグラフト)心臓弁に適用する。バイオ人工心臓弁の処理が完了すると、弁は次に、バイオ人工インプラントとして利用される任意のヒト移植片タイプ心臓弁の使用にしたがった様式で使用できる。
例1〜3のいずれかによって、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]ポリマーを調製し、図3もしくは図4に例示したような組織タイプの心臓弁、または図5に示した組織弁尖と合成輪状部分およびフレームとを含む心臓弁に適用する。バイオ人工心臓弁の処理が完了すると、弁は次に、特定タイプの任意の心臓弁がバイオ人工インプラントとして利用される様式によって使用できる。
Claims (24)
- 生物組織および次の式によって表されるポリホスファゼンを含むバイオ人工心臓弁であり、
- R1〜R6のうちの少なくとも1つは、少なくとも1つのフッ素原子で置換されたアルコキシ基である、請求項1に記載のバイオ人工心臓弁。
- 前記ポリホスファゼンは、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]である、請求項1に記載のバイオ人工心臓弁。
- 前記ポリホスファゼンは、前記生物組織内もしくは上にコーティングされる、拡散させられる、含浸させられる、グラフト化される、またはそれらの任意の組み合わせが実施される、請求項1に記載のバイオ人工心臓弁。
- 前記ポリホスファゼンは、約1nm〜約100μmの厚さで前記生物組織上にコーティングされる、請求項1に記載のバイオ人工心臓弁。
- 前記ポリホスファゼンは、約10,000,000〜約13,000,000ダルトンの平均分子量を有する、請求項1に記載のバイオ人工心臓弁。
- 前記生物組織は、哺乳動物心臓弁、哺乳動物心膜、または哺乳動物血管移植片のうちの少なくとも1つを含む、請求項1に記載のバイオ人工心臓弁。
- バイオ人工心臓弁を製造する方法であって、
生物組織を提供する工程と、
前記生物組織を次の式のポリホスファゼンと接触させる工程と、を含み、
- 前記ポリホスファゼンは、前記生物組織内もしくは上にコーティングされる、拡散させられる、含浸させられる、グラフト化される、またはそれらの任意の組み合わせが実施される、請求項8に記載の方法。
- R1〜R6のうちの少なくとも1つは、少なくとも1つのフッ素原子で置換されたアルコキシ基である、請求項8に記載の方法。
- 前記ポリホスファゼンは、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]である、請求項8に記載の方法。
- 前記生物組織は、哺乳動物心臓弁、哺乳動物心膜、または哺乳動物血管移植片のうちの少なくとも1つを含む、請求項8に記載の方法。
- 前記生物組織を前記ポリホスファゼン溶液と接触させる工程の前に、ポリホスファゼン溶液を形成するために、前記ポリホスファゼン、固定剤、界面活性剤、およびポリホスファゼン可溶性有機溶媒を結合する工程をさらに含む、請求項8に記載の方法。
- 前記ポリホスファゼンは、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]である、請求項13に記載の方法。
- 前記固定剤は、ホルムアルデヒド、グルタルアルデヒド、またはそれらの組み合わせから選択される、請求項13に記載の方法。
- 前記界面活性剤は、ポリソルベート、ポロキサマー、グリセロール、ポリエチレンイミン、キトサン、ポリアリルアミン、ポリビニルピロリドン、PVP、DEAEデキストラン、またはそれらの組み合わせから選択される、請求項13に記載の方法。
- バイオ人工心臓弁の抗血栓性、生体適合性、もしくは血液適合性の特性を改善する方法であって、
前記バイオ人工心臓弁を次の式のポリホスファゼンと接触させる工程を含み、
前記ポリホスファゼンは、前記バイオ人工心臓弁内もしくは上にコーティング、拡散、含浸、グラフト化、またはそれらの任意の組み合わせで設けられる、方法。 - 前記ポリホスファゼンは、約1nm〜約100μmの厚さで前記バイオ人工心臓弁上にコーティングされる、請求項17に記載の方法。
- R1〜R6のうちの少なくとも1つは、少なくとも1つのフッ素原子で置換されたアルコキシ基である、請求項17に記載の方法。
- 前記ポリホスファゼンは、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]である、請求項17に記載の方法。
- 前記ポリホスファゼンは、約10,000,000〜約13,000,000ダルトンの分子量を有する、請求項17に記載の方法。
- 前記バイオ人工心臓弁を前記ポリホスファゼン溶液と接触させる工程の前に、ポリホスファゼン溶液を形成するために、前記ポリホスファゼン、固定剤、界面活性剤、およびポリホスファゼン可溶性有機溶媒を結合する工程をさらに含み、
前記ポリホスファゼンは、ポリ[ビス(トリフルオロエトキシ)ホスファゼン]であり、
前記固定剤は、ホルムアルデヒド、グルタルアルデヒド、またはそれらの組み合わせから選択され、
前記界面活性剤は、ポリソルベート、ポロキサマー、グリセロール、またはそれらの組み合わせから選択される、請求項17に記載の方法。 - 哺乳動物心臓弁およびポリ[ビス(トリフルオロエトキシ)ホスファゼン]を含む、バイオ人工心臓弁。
- バイオ人工心臓弁を製造する方法であって、
哺乳動物心臓弁を提供する工程と、
前記哺乳動物心臓弁をポリ[ビス(トリフルオロエトキシ)ホスファゼン]と接触させる工程と、を含み、
前記ポリ[ビス(トリフルオロエトキシ)ホスファゼン]は、前記哺乳動物心臓弁内もしくは上にコーティング、拡散、含浸、グラフト化、またはそれらの任意の組み合わせで設けられる、方法。
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2007
- 2007-10-10 JP JP2009532558A patent/JP2010505597A/ja active Pending
- 2007-10-10 EP EP07868409A patent/EP2089071B1/en not_active Not-in-force
- 2007-10-10 AU AU2007307715A patent/AU2007307715B2/en not_active Ceased
- 2007-10-10 ES ES07868409T patent/ES2378905T3/es active Active
- 2007-10-10 BR BRPI0717738A patent/BRPI0717738A2/pt not_active Application Discontinuation
- 2007-10-10 PT PT07868409T patent/PT2089071E/pt unknown
- 2007-10-10 CN CN2007800432709A patent/CN101541354B/zh not_active Expired - Fee Related
- 2007-10-10 WO PCT/US2007/080969 patent/WO2008045949A2/en active Application Filing
- 2007-10-10 AT AT07868409T patent/ATE537853T1/de active
- 2007-10-10 US US11/869,889 patent/US7922764B2/en not_active Expired - Fee Related
- 2007-10-10 CA CA2690539A patent/CA2690539C/en active Active
- 2007-10-10 KR KR1020097009150A patent/KR101083471B1/ko not_active IP Right Cessation
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2009
- 2009-04-16 IL IL198148A patent/IL198148A0/en unknown
-
2010
- 2010-02-05 HK HK10101356.4A patent/HK1137669A1/xx unknown
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DE19613048A1 (de) * | 1995-03-30 | 1996-10-02 | Michael Prof Dr Grunze | Künstliche Implantate mit antithrombogenen Eigenschaften und Verfahren zu deren Herstellung |
JP2004531231A (ja) * | 2001-01-11 | 2004-10-14 | ポリゼニックス ゲーエムベーハー | マトリクスとしてのポリホスファゼン含有支持体および微細構造化表面を備えるポリホスファゼン含有支持体 |
JP2006503605A (ja) * | 2002-04-30 | 2006-02-02 | フイット バイオテク オーワイジェイ ピーエルシー | 医療装置 |
Also Published As
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AU2007307715A8 (en) | 2009-05-28 |
US7922764B2 (en) | 2011-04-12 |
PT2089071E (pt) | 2012-03-09 |
WO2008045949A3 (en) | 2009-06-04 |
KR20090086980A (ko) | 2009-08-14 |
HK1137669A1 (en) | 2010-08-06 |
ATE537853T1 (de) | 2012-01-15 |
CN101541354A (zh) | 2009-09-23 |
CN101541354B (zh) | 2012-11-21 |
KR101083471B1 (ko) | 2011-11-16 |
BRPI0717738A2 (pt) | 2018-09-11 |
ES2378905T3 (es) | 2012-04-19 |
EP2089071A2 (en) | 2009-08-19 |
WO2008045949A2 (en) | 2008-04-17 |
AU2007307715A1 (en) | 2008-04-17 |
AU2007307715B2 (en) | 2012-08-30 |
US20080086205A1 (en) | 2008-04-10 |
IL198148A0 (en) | 2009-12-24 |
CA2690539A1 (en) | 2008-04-17 |
EP2089071B1 (en) | 2011-12-21 |
CA2690539C (en) | 2014-10-07 |
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