JP2009513239A - 親水性のポリマー歯科用スポンジ - Google Patents
親水性のポリマー歯科用スポンジ Download PDFInfo
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- JP2009513239A JP2009513239A JP2008537698A JP2008537698A JP2009513239A JP 2009513239 A JP2009513239 A JP 2009513239A JP 2008537698 A JP2008537698 A JP 2008537698A JP 2008537698 A JP2008537698 A JP 2008537698A JP 2009513239 A JP2009513239 A JP 2009513239A
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- hydrophilic polymer
- chitosan
- bone
- tissue
- polymer sponge
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Abstract
Description
本出願は、米国特許出願第10/743,052号(2004年12月23日出願、発明の名称「Wound Dressing and Method of Controlling Severe Life−Threatening Bleeding」)の一部継続出願であり、この出願は、米国特許出願第10/480,827号(2003年12月15日出願、発明の名称「Wound Dressing and Method of Controlling Severe Life−Threatening Bleeding」)の一部継続出願であり、この出願は、国際出願PCT/US02/18757(2002年6月14日出願)の米国特許法第371条の下での国内段階であり、この出願は、仮特許出願第60/298,773号(2001年6月14日出願)に対する優先権を主張しており、これらは各々、本明細書中で参考として援用される。
本発明は、全体として、治癒を促進すると同時に出血、流体の漏出もしくは浸出、または他の形の体液喪失を改善するために歯科処置中またはその後に施される組成物、アセンブリ、および方法を対象としている。
図1は、健康な歯の解剖図である。歯は、歯冠と歯根とを含む。歯根は、靱帯に支持されて歯槽(顎)骨内に入っている。靱帯は、衝撃を吸収する結合組織の強靭な帯を含んでおり、これは、歯根を物理的に顎骨に結合している。この骨内の歯によって占有されている穴は、歯槽と呼ばれる。
本発明は、親水性ポリマースポンジ構造体の配置を含む、口腔もしくは隣接する解剖学的構造物内の組織または骨を治療するためのアセンブリ、システムおよび方法を提供する。
当業者が本発明を実施することができるように、本発明の開示内容を詳細かつ正確に説明するが、本明細書に開示する物理的実施形態は本発明を単に例示するものに過ぎず、それらを他の特定の構造物に具現してもよい。好ましい実施形態を説明してきたが、特許請求の範囲によって定義される本発明から逸脱することなく、詳細を変更することができる。
図2に、抜歯後にむき出しの状態で残された歯槽を示す。図3Aおよび図3Bに、摘出部位のむき出しの歯槽内への配置後の、本発明の特徴を具現した歯科用パッドアセンブリ10を示す。図3Aおよび図3Bでは、歯科用パッドアセンブリ10は、抜歯後のむき出しの歯槽内へ挿入または「詰める」ことができるような形状、大きさ、および構成となっている。摘出には、単一の歯(図に示すような)または複数の歯を含めることができる。
組織被覆マトリックス12は、低弾性の親水性ポリマーマトリックス、すなわち、後に説明する後続の緻密化工程で緻密化された、本質的に「非圧縮」の組織被覆マトリックス12から形成されることが好ましい。先に述べたように、組織被覆マトリックス12は、好ましい形態では、より一般的にはキトサンと呼ばれる非哺乳類材料のポリ[β−(1→4)−2−アミノ−2−デオキシ−D−グルコピラノースを含む、親水性のポリマー形を備えることができる。
図5Aおよび図5Bに示すように、(あらかじめ大きさが定められた歯科用パッドアセンブリ10の形、またはあらかじめ大きさが定められた歯科用パッドアセンブリ10を切り取ることができるより大きいソースパッドアセンブリ11としての)キトサンマトリックス12は、気密の、ヒートシールされた、ホイルで裏張りを施したポーチ16内に、低水分含量、好ましくは5%以下の水分と共に、使用前に真空包装されることが望ましい。歯科用パッドアセンブリ10またはソースアセンブリ11はその後、γ線照射の使用によってポーチ16内で終末滅菌される。図5Bに示すように、より小さいパッドアセンブリ10を切り取って大きさを整えることができるソースパッドアセンブリ11も、使用前に、ポーチ16内に滅菌状態で真空包装することができる。
ひとたびポーチ16から取り出せば(図6参照)、歯科用パッドアセンブリ10は、標的組織部位に直ちに粘着させることができる。粘着を促進するための使用前操作は必要としない。例えば、使用に備えて接着面を露出させるために保護物質を剥離する必要はない。ひとたび血液、流体、または湿気と接触するとキトサンマトリックス12自体が強固な粘着特性を示すため、粘着面はそのままの状態で形成される。歯科用パッドアセンブリ10は、ポーチ16を開封すると同時に直ちに標的部位に施す必要はない。
ここで、組織被覆用パッドアセンブリ10の望ましい作製方法を説明する。この方法は、図10Aから図10Hに概略的に示されている。もちろん、他の方法を用いてもよいことを理解されたい。
キトサン溶液(図10、ステップAではCSで示す)を調製するのに用いるキトサンは、0.78より大きいが0.97より小さい分数脱アセチル化度を有することが好ましい。キトサンは、0.85より大きいが0.95より小さい分数脱アセチル化度を有するのが最も好ましい。マトリックスに加工するために選択されるキトサンは、30rpmのスピンドルLV1で1%(w/w)酢酸(AA)の1%(w/w)溶液中において、25℃で約100センチポアズ〜約2000センチポアズの粘度を有することが好ましい。キトサンは、30rpmのスピンドルLV1で1%(w/w)酢酸(AA)の1%(w/w)溶液中において、25℃で約125センチポアズ〜約1000センチポアズの粘性を有するのがより好ましい。キトサンは、30rpmのスピンドルLV1で1%(w/w)酢酸(AA)の1%(w/w)溶液中において、25℃で約400センチポアズ〜約800センチポアズの粘性を有するのが最も好ましい。
キトサン生体材料溶液CSについては、一般的な大気中の気体類の脱気が行われることが好ましい(図10、ステップB参照)。一般に、脱気によってキトサン生体材料溶液CSから十分な残留気体が除去され、これにより、後続の凍結作業を受ける際に気体が逃げて本創傷被覆用製品内に望ましくない大きい空洞または大きい捕捉気泡を形成することがない。脱気ステップは、一般的には溶液CSの形態のキトサン生体材料を加熱し、次いでそれに真空を印加することによって行うことができる。例えば、脱気は、溶液をかき混ぜながら約45℃までキトサン溶液を加熱し、その直後に約500mトールで約5分間真空を印加することによって行うことができる。
次に、(図10、ステップC参照)、キトサン生体材料(上に述べたように、一般的に、ここでは酸性溶液中にあって脱気されている)は、凍結ステップに供される。凍結は、鋳型内で支持されたキトサン生体材料溶液を冷却し、該溶液の温度を室温から氷点下の最終温度まで下げることによって実行されるのが好ましい。この凍結ステップはプレートフリーザ上で実行されるのがより好ましく、それによって、プレートの冷却面を介した熱の損失による温度勾配が鋳型内のキトサン溶液全体に導入される。このプレート冷却面は、鋳型と良好な熱的接触状態にあることが好ましい。プレートフリーザの表面との接触前のキトサン溶液および鋳型の温度は室温に近いことが好ましい。プレートフリーザの表面温度は、鋳型+溶液の導入前は−10℃より高くないことが好ましい。鋳型+溶液の熱質量は、プレートフリーザの棚板+熱伝導流体の熱質量よりも小さいことが好ましい。鋳型は、限定するものではないが、鉄、ニッケル、銀、銅、アルミニウム、アルミニウム合金、チタン、チタン合金、バナジウム、モリブデン、金、ロジウム、パラジウム、プラチナおよび/またはそれらの組み合わせのような金属元素から形成されることが好ましい。鋳型は、キトサン溶液の酸成分およびキトサン塩マトリックスとの反応がないことを確実にするために、チタン、クロム、タングステン、バナジウム、ニッケル、モリブデン、金およびプラチナのような、薄い、不活性の金属被膜でコーティングすることもできる。鋳型内の熱伝達を制御するために、金属の鋳型と併せて、断熱コーティングまたは断熱成分を用いることができる。鋳型の表面は、凍結したキトサン溶液と結合しないことが好ましい。鋳型の内側表面は、ポリテトラフルオロエチレン(テフロン(登録商標))、フッ素化エチレンポリマー(FEP)、または他のフッ素化ポリマー材料から形成された、薄い、永久結合されたフッ素化剥離剤塗布によってコーティングされていることが好ましい。コーティングされた金属鋳型が好ましいが、壁の薄いプラスチックの鋳型は、溶液の支持に好都合な代替物とすることができる。そのようなプラスチックの鋳型には、限定するものではないが、ポリ塩化ビニル、ポリスチレン、アクリロニトリルとブタジエンとスチレンの共重合体類、ポリエステル類、ポリアミド類、ポリウレタン類、およびポリオレフィン類から射出成形、機械加工または熱成形によって調製された鋳型が含まれる。断熱成分の局所配置と組み合わせた金属鋳型の利点は、それらが熱流制御の改善および凍結スポンジ内部の構造改善の機会をも提供することにある。この熱流制御の改善は、鋳型内の熱伝導成分の配置と断熱成分の配置との間における大きな熱伝導性の差に起因する。
凍結したキトサン/氷のマトリックス(FCS)は、凍結した材料(図10、ステップD参照)の隙間内から水分を除去されることが望ましい。この水分除去ステップは、凍結したキトサン生体材料FCSの構造的完全性を損なうことなく達成することができる。これは、最終のキトサンマトリックス12の構造配列を崩壊させる可能性のある液相を生成することなく達成することができる。従って、凍結キトサン生体材料FSC中の氷は、中間の液相を形成することなく、固体の凍結相から気相へ通過する(昇華)。昇華した気体は、凍結キトサン生体材料よりも実質的に低い温度で、真空の復水器チャンバ内に氷として捕捉される。
緻密化前のキトサンマトリックス(0.03g/cm3近傍の密度)を「非圧縮キトサンマトリックス」と呼ぶことにする。この非圧縮マトリックスは、それが急速に血液中に溶解し、また機械的特性が芳しくないことから、出血を止めるにあたっては理想的ではない。従って、キトサン生体材料は、圧縮されることが望ましい(図10、ステップE参照)。加熱プラテンによる親水性マトリックスポリマーの表面に対して垂直な圧縮負荷は、乾燥した「非圧縮」キトサンマトリックス12を圧縮し、厚みを減少させてマトリックスの密度を高めるために用いることができる。手短に「緻密化」と呼ぶこともある圧縮ステップで、キトサンマトリックス12の粘着強度、凝集強度および溶解抵抗性が大幅に増大する。閾値密度(0.1g/cm3に近い)を越えて圧縮された、適切に凍結されたキトサンマトリックス12(複数)は、37℃で流れる血液中に容易には溶解しない。
組織被覆用パッドアセンブリ10はその後、事前に切り取られた大きさで、またはソースパッドアセンブリ11として、ポーチ16(図16、ステップF参照)内に包装することができる。ポーチ16は、アルゴンガスまたは窒素ガスのような不活性気体でパージされ、排気およびヒートシールされることが望ましい。ポーチ16は、内側にある内容物を長期間(少なくとも24ヶ月)にわたって無菌的に保持する役割を果たし、かつ同期間にわたって、湿気および大気気体の浸透に対する極めて高い障壁ともなる。
ポーチに入れた後、処理された組織被覆用パッドアセンブリ10は、滅菌ステップ(図10、ステップG参照)に供されることが望ましい。組織被覆用パッドアセンブリ10は、多くの方法で滅菌することができる。例えば、好ましい方法は、γ線照射によるなどの照射による方法であり、これによって、創傷被覆材の血液溶解抵抗性、引張特性および粘着特性をさらに増強することができる。照射は、少なくとも約5kGy、より好ましくは少なくとも約10kGy、最も好ましくは少なくとも約15kGyのレベルで行うことができる。
損傷部位を標的とした治療に関しての配置に先立つパッドアセンブリ10の曲げおよび/または成形についてはすでに説明済みであり、推奨されるものである。パッドアセンブリ10が唯一の例である親水性ポリマースポンジ構造体では、構造がより可撓性を有しより適合性を有するほど、親水性ポリマースポンジ構造体は、引裂および断片化に対してより抵抗性が高まり、該構造体が標的治療部位の形状に適合するように、かつ下に位置する(一般的に)損傷のでこぼこした面とのスポンジ構造体の並置を達成されるようになる。引裂および断片化に対する抵抗性は、それが創傷の密封および止血効果を維持するので利点となる。
歯科用パッドアセンブリ10は、種々の代替的形態で提供することができる。
キトサンマトリックス12のような親水性ポリマースポンジ構造体は、歯科処置または口腔に関連する外傷と関連させた種々の大きさおよび構造の被覆材またはプラットフォームと関連するように、パッド形、シート形、または他の適合する形で容易に適合させることができることを実証してきた。
Claims (11)
- 口腔もしくは隣接する解剖学的構造物内の組織または骨と関連させて配置することを目的とした形状、大きさ、および構成を有する親水性ポリマースポンジ構造体。
- 前記親水性ポリマースポンジ構造体は、キトサン生体材料を含む、請求項1に記載の構造体。
- 前記親水性ポリマースポンジ構造体は、使用に先立ち、圧縮によって0.6g/cm3から0.1g/cm3までの間の密度まで緻密化されている、請求項1に記載の構造体。
- 口腔もしくは隣接する解剖学的構造物内の組織または骨と関連させて親水性ポリマースポンジ構造体を配置する工程を含む方法。
- 前記親水性ポリマースポンジ構造体は、キトサン生体材料を含む、請求項4に記載の方法。
- 前記親水性ポリマースポンジ構造体は、使用に先立ち、圧縮によって0.6g/cm3から0.1g/cm3までの間の密度まで緻密化されている、請求項4に記載の方法。
- 親水性ポリマースポンジ構造体は、抜歯窩内に配置される、請求項4に記載の方法。
- 抜歯、歯内手術、歯根膜手術、矯正治療、顎矯正手術、生検、歯肉手術、骨手術、歯石除去もしくは根面平滑化、歯周維持、上顎総義歯もしくは下顎総義歯、総義歯調整もしくは部分義歯調整、義歯のリベースもしくはリライン、手術による軟組織の摘出、手術による骨の摘出、咬合矯正装置もしくは咬合ガードの取り付けあるいは咬合調整、顎再建を含む口腔手術、骨成長もしくは骨成長促進、または前記口腔内の組織、前記口腔内の解剖学的構造物、もしくは歯槽(顎)骨に影響を及ぼす他のあらゆる外科的な処置あるいは介入のうちの少なくとも1つを含む外科的処置を実行する工程と、
前記外科的処置によって影響を受けた組織または骨と関連させて親水性ポリマースポンジ構造体を配置する工程と、
を含む方法。 - 組織または骨に損傷または外傷を引き起こす事故により口腔または歯槽(顎)骨内の組織を治療する工程と、
前記治療を受けた組織または骨と関連させて親水性ポリマースポンジ構造体を配置する工程と、
を含む方法。 - 前記親水性ポリマースポンジ構造体は、キトサン生体材料を含む、請求項8または請求項9に記載の方法。
- 前記親水性ポリマースポンジ構造体は、使用に先立ち、圧縮によって0.6g/cm3から0.1g/cm3までの間の密度まで緻密化されている、請求項8または請求項9に記載の方法。
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- 2006-08-02 JP JP2008537698A patent/JP5474351B2/ja active Active
- 2006-08-02 WO PCT/US2006/030283 patent/WO2007055761A2/en active Application Filing
- 2006-08-02 CN CN200680047919XA patent/CN101340872B/zh active Active
- 2006-08-02 AU AU2006312267A patent/AU2006312267A1/en not_active Abandoned
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2018535129A (ja) * | 2015-11-27 | 2018-11-29 | サクミ・イモラ・ソシエタ・コーペラティバSacmi Imola S.C. | 容器をブロー成形するのための装置 |
CN111787892A (zh) * | 2017-12-29 | 2020-10-16 | 金珂生物医疗公司 | 抵抗溶解的组织粘附脱乙酰壳多糖材料 |
JP2021508751A (ja) * | 2017-12-29 | 2021-03-11 | トリコル バイオメディカル, インコーポレイテッド | 溶解に耐える組織接着性キトサン材料 |
KR20220019892A (ko) | 2020-08-10 | 2022-02-18 | 김인석 | 발치와 충전용 충전재 및 발치와 충전용 충전재 키트 |
Also Published As
Publication number | Publication date |
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KR101406566B1 (ko) | 2014-06-11 |
EP1945162A2 (en) | 2008-07-23 |
CN101340872A (zh) | 2009-01-07 |
CN101340872B (zh) | 2013-07-24 |
WO2007055761A2 (en) | 2007-05-18 |
KR20080100161A (ko) | 2008-11-14 |
EP1945162A4 (en) | 2012-03-28 |
JP5474351B2 (ja) | 2014-04-16 |
CA2627483A1 (en) | 2007-05-18 |
AU2006312267A1 (en) | 2007-05-18 |
US7897832B2 (en) | 2011-03-01 |
WO2007055761A3 (en) | 2008-01-03 |
US20060089584A1 (en) | 2006-04-27 |
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