JP6096190B2 - 熱可塑性多層物品 - Google Patents
熱可塑性多層物品 Download PDFInfo
- Publication number
- JP6096190B2 JP6096190B2 JP2014525512A JP2014525512A JP6096190B2 JP 6096190 B2 JP6096190 B2 JP 6096190B2 JP 2014525512 A JP2014525512 A JP 2014525512A JP 2014525512 A JP2014525512 A JP 2014525512A JP 6096190 B2 JP6096190 B2 JP 6096190B2
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- Japan
- Prior art keywords
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- multilayer article
- thermoplastic
- base layer
- 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.)
- Expired - Fee Related
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Images
Classifications
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- 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
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- 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
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/31504—Composite [nonstructural laminate]
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Description
本願は、2011年8月16日に出願された米国仮特許出願第61/524,046号に対する優先権の利益を主張するものであり、該仮特許出願は参照によりその全体が本明細書に組み込まれる。
本発明は、一般に、多層物品に関する。より詳細には、本発明は、患者に移植するのに適した多層物品に関する。本発明のいくつかの実施形態は、1つ以上の熱可塑性層と1つ以上の基層とを有する多層物品に関する。本発明の更なる実施形態は、多層物品の製造方法に関する。
a.基層を提供する工程、
b.任意に、該基層の表面を処理する工程、
c.熱可塑性層を基層に重ね合わせる工程、
d.熱可塑性層を基層上に溶融して積層体を形成する工程、
e.積層体を冷却する工程、及び
f.積層体を成形する工程。
ポリエチレンテレフタレート(PET)のガラス転移温度以上で変形可能となる骨接合用プレートを、次の方法で製造した。
1.厚さ0.05mmのチタン(Ti)箔の表面を、DLC層をコーティングした後、酸素プラズマで表面活性化処理することによって処理した。最初にチタン箔を有機溶剤中で超音波洗浄し、その後乾燥させた。洗浄、乾燥済みのチタン箔を真空装置に入れ、約10−5Pa(10−7mbar)のベース圧力まで排気した。次に、アルゴンガスボンバード処理を約2Pa(2・10−2mbar)で行ってチタン箔を洗浄した。次に、DLC層をチタン箔の表面に堆積させた。このDLC層は、所望の厚さ(例えば約10μm未満)を有することができる。DLC層は、アセチレンからの蒸着によって基材上に堆積された。次に、DLC層を、酸素圧1Pa(1・10−2mbar)、面積100cm2当たりのプラズマ出力20ワット、処理時間5分で高周波放電によって活性化させた。DLCでコーティングされたTi箔を真空チャンバから取り出した。
2.DLC処理を施したTi箔と厚さ0.1mmのポリエチレンテレフタレート(PET)箔との10層の交互層(寸法10×1cm)の積層体を調製した。
3.加熱可能なプレスの中で98.1kPa(1kg/cm2)の圧力を積層体に付加した。
4.この積層体を280℃まで1分にわたり加熱し、PETを溶融し、層を接合した。
5.この積層体を室温まで冷却し、プレスから取り出した。
6.得られたプレートを水ジェット切断により成形した。
変形可能な頭蓋骨フラップインプラントを次の方法で作製した。
1.厚さ0.01mmのポリエーテルエーテルケトン(PEEK)箔の表面を、真空酸素プラズマ処理によって活性化させた。
2.PEEK箔と厚さ0.05mmのPET箔との100層の交互層の積層体を調製した。
3.加熱可能なプレスの中で980.7kPa(10kg/cm2)の圧力を積層体に付加した。
4.この積層体を280℃まで3分にわたり加熱し、PETを溶融し、層を接合した。
5.この積層体を室温まで冷却し、プレスから取り出した。
6.得られたプレートを水ジェット切断により成形した。
(1) 第1の表面と、前記第1の表面の反対側の第2の表面とを有する熱可塑性層と、
第1の基面と、前記第1の基面の反対側の第2の基面とを有する基層と、を含む多層物品であって、
前記基層の前記第1の基面が、前記熱可塑性層の前記第2の表面に永続的に結合され、前記熱可塑性層が、第1のガラス転移温度Tg Iを有する第1の熱可塑性材料を含み、前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性である、多層物品。
(2) 交互の層に配置された複数の熱可塑性層と複数の基層とを更に含む、実施態様1に記載の多層物品。
(3) 前記熱可塑性層が、ポリエチレンテレフタレート、ポリカプロアミド、ポリカプロラクトン、ポリトリメチレンカーボネート、ポリグリコリド−コ−トリメチレンカーボネート、ポリ(PBA−カーボネート)、ポリ(β−ヒドロキシブチレート)、ポリヒドロキシブチレート−ヒドロキシ吉草酸、及びこれらの組み合わせからなる群から選択される材料を含む、実施態様1又は2に記載の多層物品。
(4) 前記基層が生体適合性金属材料を含む、実施態様1〜3のいずれかに記載の多層物品。
(5) 前記生体適合性金属材料が、チタン、チタン合金、コバルト−クロム合金、コバルト−クロム−モリブデン合金、モリブデン合金、タンタル、ニチノール、ゴムメタル(GUMMETAL)(登録商標)、ステンレス鋼、及びばね鋼からなる群から選択される材料を含む、実施態様4に記載の多層物品。
(7) 前記基層が、Tg Iより少なくとも50℃高い第2のガラス転移温度Tg IIを有する第2の熱可塑性材料を含む、実施態様1〜3のいずれかに記載の多層物品。
(8) 前記第2の熱可塑性材料が、ポリエチレンテレフタレート、ポリカーボネート、ポリアリールエーテルケトン、ポリエーテルエーテルケトン、ポリエーテルケトンケトン、繊維強化ポリエーテルエーテルケトン、繊維強化ポリエーテルケトンケトン、及びこれらの組み合わせからなる群から選択される材料を含む、実施態様7に記載の多層物品。
(9) 溶融したときの前記第1の熱可塑性材料と、前記第2の熱可塑性材料との間の界面が、5°未満の接触角を形成する、実施態様7又は8に記載の多層物品。
(10) 0.1mm〜3.0mmの範囲の厚さを有する、実施態様1〜9のいずれかに記載の多層物品。
(12) 実施態様1〜11のいずれかに記載の多層物品から作製される骨プレート。
(13) 実施態様1〜11のいずれかに記載の多層物品から作製された、コイルばね形状を有する熱解除型ばね要素(thermally releasing spring element)。
(14) 多層物品の形成方法であって、
第1の基面と、前記第1の基面の反対側の第2の基面とを有する基層とを提供する工程と、
前記基層の前記第1の基面に、溶融温度Tm、及び第1のガラス転移温度Tg Iを有する熱可塑性層を適用して、多層物品を形成する工程と、
前記多層物品に圧力を付加する工程と、
前記多層物品を、Tmを少なくとも10℃超えるまで少なくとも1分間にわたり加熱して、前記熱可塑性層を、前記基層の前記表面に永続的に固着する工程と、
を含み、
前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性である、多層物品の形成方法。
(15) 前記基層が生体適合性金属材料を含む、実施態様14に記載の方法。
前記ダイヤモンド状炭素層を酸素プラズマで活性化する工程と、
を更に含む、実施態様15に記載の方法。
(17) 前記基層が、Tg Iより少なくとも50℃高い第2のガラス転移温度Tg IIを有する第2の熱可塑性材料を含む、実施態様14に記載の方法。
(18) 前記多層物品を冷却する工程と、
前記多層物品を成形して変形可能なインプラントを形成する工程と、
を更に含む、実施態様14〜17のいずれかに記載の方法。
(19) 前記多層物品を巻回してコイルばね形状を形成する工程、を更に含む、実施態様14〜17のいずれかに記載の方法。
(20) 複数の骨片を固定する方法であって、
熱可塑性層及び基層の交互層を含む積層プレートを提供する工程であって、前記熱可塑性層は、第1の表面と、前記第1の表面の反対側の第2の表面とを有し、前記基層は、第1の基面と、前記第1の基面の反対側の第2の基面とを有し、前記基層の前記第1の基面が、前記熱可塑性層の前記第2の表面に永続的に結合され、前記熱可塑性層が、第1のガラス転移温度Tg Iを有し、前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性である、工程と、
前記積層プレートをTg Iを超える温度まで加熱して、前記積層プレートを変形させる工程であって、前記積層プレートが少なくとも1つの方向に変形可能である、工程と、
前記変形した積層プレートを前記複数の骨片に固定する工程と、
を含む、複数の骨片を固定する方法。
(22) ばね要素を空洞の中に固定する方法であって、
熱解除型ばね要素を提供する工程であって、前記熱解除型ばね要素が、熱可塑性層及び基層の交互層のコイル巻きされた多層物品を含み、前記熱可塑性層は、第1の表面と、前記第1の表面の反対側の第2の表面とを有し、前記基層は、第1の基面と、前記第1の基面の反対側の第2の基面とを有し、前記基層の前記第1の基面が、前記熱可塑性層の前記第2の表面に永続的に結合され、前記熱可塑性層が、第1のガラス転移温度Tg Iを有し、前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性である、工程と、
前記熱解除型ばね要素を空洞に挿入する工程と、
前記熱解除型ばね要素をTg Iを超える温度まで加熱する工程であって、前記熱解除型ばね要素を加熱することが、前記多層を少なくとも部分的に前記空洞の中に広げさせる、工程と、
を含む、ばね要素を空洞の中に固定する方法。
(23) 前記コイル巻きされた多層物品が、中心棒の周囲にコイル巻きされる、実施態様22に記載の方法。
Claims (17)
- 第1の表面と、前記第1の表面の反対側の第2の表面とを有する熱可塑性層と、
第1の基面と、前記第1の基面の反対側の第2の基面とを有する基層と、を含む多層物品であって、
前記基層の前記第1の基面が、前記熱可塑性層の前記第2の表面に永続的に結合され、前記熱可塑性層が、第1のガラス転移温度Tg Iを有する第1の熱可塑性材料を含み、前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性であり、前記基層が生体適合性金属材料を含む、多層物品。 - 交互の層に配置された複数の熱可塑性層と複数の基層とを更に含む、請求項1に記載の多層物品。
- 前記熱可塑性層が、ポリエチレンテレフタレート、ポリカプロアミド、ポリカプロラクトン、ポリトリメチレンカーボネート、ポリグリコリド−コ−トリメチレンカーボネート、ポリ(PBA−カーボネート)、ポリ(β−ヒドロキシブチレート)、ポリヒドロキシブチレート−ヒドロキシ吉草酸、及びこれらの組み合わせからなる群から選択される材料を含む、請求項1又は2に記載の多層物品。
- 前記生体適合性金属材料が、チタン、チタン合金、コバルト−クロム合金、コバルト−クロム−モリブデン合金、モリブデン合金、タンタル、ニチノール、ゴムメタル(GUMMETAL)(登録商標)、ステンレス鋼、及びばね鋼からなる群から選択される材料を含む、請求項1〜3のいずれか一項に記載の多層物品。
- 前記熱可塑性層及び前記基層が、前記熱可塑性層と前記基層との間に位置付けられたダイヤモンド状炭素中間層によって永続的に結合される、請求項1〜4のいずれか一項に記載の多層物品。
- 0.1mm〜3.0mmの範囲の厚さを有する、請求項1〜5のいずれか一項に記載の多層物品。
- 0.1mm〜1.5mmの範囲の厚さを有する、請求項1〜6のいずれか一項に記載の多層物品。
- 請求項1〜7のいずれか一項に記載の多層物品から作製される骨プレート。
- 請求項1〜7のいずれか一項に記載の多層物品から作製された、コイルばね形状を有する熱解除型ばね要素。
- 多層物品の形成方法であって、
第1の基面と、前記第1の基面の反対側の第2の基面とを有する基層を提供する工程と、
前記基層の前記第1の基面に、溶融温度Tm、及び第1のガラス転移温度Tg Iを有する熱可塑性層を適用して、多層物品を形成する工程と、
前記多層物品に圧力を付加する工程と、
前記多層物品を、Tmを少なくとも10℃超えるまで少なくとも1分間にわたり加熱して、前記熱可塑性層を、前記基層の前記基面に永続的に固着する工程と、
を含み、
前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性であり、前記基層が生体適合性金属材料を含む、多層物品の形成方法。 - 前記生体適合性金属材料の前記基面をダイヤモンド状炭素でコーティングして、前記熱可塑性層と前記基層との間に位置付けられたダイヤモンド状炭素中間層を形成する工程と、
前記ダイヤモンド状炭素層を酸素プラズマで活性化する工程と、
を更に含む、請求項10に記載の方法。 - 前記多層物品を冷却する工程と、
前記多層物品を成形して変形可能なインプラントを形成する工程と、
を更に含む、請求項10又は11に記載の方法。 - 前記多層物品を巻回してコイルばね形状を形成する工程、を更に含む、請求項10又は11に記載の方法。
- 複数の骨片を固定する方法であって、
熱可塑性層及び基層の交互層を含む積層プレートを提供する工程であって、前記熱可塑性層は、第1の表面と、前記第1の表面の反対側の第2の表面とを有し、前記基層は、第1の基面と、前記第1の基面の反対側の第2の基面とを有し、前記基層の前記第1の基面が、前記熱可塑性層の前記第2の表面に永続的に結合され、前記熱可塑性層が、第1のガラス転移温度Tg Iを有し、前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性である、工程と、
前記積層プレートをTg Iを超える温度まで加熱して、前記積層プレートを変形させる工程であって、前記積層プレートが少なくとも1つの方向に変形可能である、工程と、
前記変形した積層プレートを前記複数の骨片に固定する工程と、
を含む、複数の骨片を固定する方法。 - 前記加熱工程が複数回繰り返される、請求項14に記載の方法。
- ばね要素を空洞の中に固定する方法であって、
熱解除型ばね要素を提供する工程であって、前記熱解除型ばね要素が、熱可塑性層及び基層の交互層のコイル巻きされた多層物品を含み、前記熱可塑性層は、第1の表面と、前記第1の表面の反対側の第2の表面とを有し、前記基層は、第1の基面と、前記第1の基面の反対側の第2の基面とを有し、前記基層の前記第1の基面が、前記熱可塑性層の前記第2の表面に永続的に結合され、前記熱可塑性層が、第1のガラス転移温度Tg Iを有し、前記多層物品が、Tg I未満の温度で剛性であり、かつTg Iを超える温度で可撓性である、工程と、
前記熱解除型ばね要素を空洞に挿入する工程と、
前記熱解除型ばね要素をTg Iを超える温度まで加熱する工程であって、前記熱解除型ばね要素を加熱することが、前記多層物品を少なくとも部分的に前記空洞の中に広げさせる、工程と、
を含み、前記基層が生体適合性金属材料を含む、ばね要素を空洞の中に固定する方法。 - 前記コイル巻きされた多層物品が、中心棒の周囲にコイル巻きされる、請求項16に記載の方法。
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US201161524046P | 2011-08-16 | 2011-08-16 | |
US61/524,046 | 2011-08-16 | ||
PCT/IB2012/001964 WO2013024355A1 (en) | 2011-08-16 | 2012-08-15 | Thermoplastic multilayer article |
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US11095994B2 (en) * | 2013-02-15 | 2021-08-17 | Cochlear Limited | Conformable pad bone conduction device |
JP2017501002A (ja) * | 2013-12-20 | 2017-01-12 | クロスローズ エクストリミティ システムズ リミテッド ライアビリティ カンパニー | 多軸ロッキング穴 |
ES2834498T3 (es) * | 2013-12-26 | 2021-06-17 | Tepha Inc | Implantes médicos que incluyen laminados de poli-4-hidroxibutirato y copolímeros del mismo |
US11202626B2 (en) | 2014-07-10 | 2021-12-21 | Crossroads Extremity Systems, Llc | Bone implant with means for multi directional force and means of insertion |
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US20130046346A1 (en) | 2013-02-21 |
EP2744447B1 (en) | 2018-10-10 |
WO2013024355A1 (en) | 2013-02-21 |
EP2744447A1 (en) | 2014-06-25 |
TW201320985A (zh) | 2013-06-01 |
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