JP2000512323A - 放射線および溶融処理済み超高分子量ポリエチレンプロテーゼデバイス - Google Patents
放射線および溶融処理済み超高分子量ポリエチレンプロテーゼデバイスInfo
- Publication number
- JP2000512323A JP2000512323A JP09529459A JP52945997A JP2000512323A JP 2000512323 A JP2000512323 A JP 2000512323A JP 09529459 A JP09529459 A JP 09529459A JP 52945997 A JP52945997 A JP 52945997A JP 2000512323 A JP2000512323 A JP 2000512323A
- Authority
- JP
- Japan
- Prior art keywords
- molecular weight
- weight polyethylene
- high molecular
- ultra
- irradiation
- 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.)
- Granted
Links
Classifications
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- 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
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Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Transplantation (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1. 体内使用のための医療用プロテーゼであって、検出可能なフリーラジカ ルを実質的に有しない放射線処理された超高分子量ポリエチレンから形成される プロテーゼ。 2. 前記放射線が、γ線および電子線から成る群より選択される、請求項1 に記載のプロテーゼ。 3. 前記超高分子量ポリエチレンが、前記プロテーゼの装着中の前記プロテ ーゼからの粒子の生成を減少させるように架橋構造を有する、請求項1に記載の プロテーゼ。 4. 前記超高分子量ポリエチレンが実質的に酸化されていない、請求項1に 記載のプロテーゼ。 5. 前記超高分子量ポリエチレンが実質的に耐酸化性である、請求項1に記 載のプロテーゼ。 6. 前記超高分子量ポリエチレンが3の融解ピークを有する、請求項1に記 載のプロテーゼ。 7. 前記超高分子量ポリエチレンが2の融解ピークを有する、請求項1に記 載のプロテーゼ。 8. 前記超高分子量ポリエチレンが1の融解ピークを有する、請求項1に記 載のプロテーゼ。 9. 前記ポリマー構造が広範囲にわたる架橋を有するために、前記ポリマー 構造のかなりの部分がキシレン中に130℃でまたはデカリン中に150℃で2 4時間にわたって溶解しない、請求項1に記載のプロテーゼ。 10.前記超高分子量ポリエチレンが、約200万を越える初期平均分子量を 有する、請求項1に記載のプロテーゼ。 11.前記プロテーゼの部材が、耐力表面を有するカップまたはトレー形物品 の形である、請求項1に記載のプロテーゼ。 12.前記耐力表面が、金属またはセラミック材料の嵌合性耐力表面を有する 前記プロテーゼの第二部材と接触している、請求項1に記載のプロテーゼ。 13.前記プロテーゼが、股関節、膝関節、肘関節、肩関節、課関節および指 関節から成る群より選択される関節の代替品用に構築されて配置される、請求項 1に記載のプロテーゼ。 14.前記超高分子量ポリエチレンが、前記プロテーゼの装着中の前記プロテ ーゼからの微粒子の生成を減少させるように、約50%未満の結晶化度、約29 0Å未満のラメラ厚みおよび約940MPa未満の引張弾性率を有するポリマー 構造を有する、請求項1に記載のプロテーゼ。 15.前記超高分子量ポリエチレンが、ショアーDスケールで約65未満の硬 度を有する、請求項14に記載のプロテーゼ。 16.前記超高分子量ポリエチレンが、不完全な結晶の生成を引き起こしそし て結晶化度を減少させるように高い絡み合い密度を有する、請求項14に記載の プロテーゼ。 17.前記超高分子量ポリエチレンが、約40%の結晶化度、約100Åのラ メラ厚みおよび約200MPaの引張弾性率を有するポリマー構造を有する、請 求項14に記載のプロテーゼ。 18.検出可能なフリーラジカルを実質的に有しない放射線処理された超高分 子量ポリエチレン。 19.前記超高分子量ポリエチレンが架橋構造を有する、請求項18に記載の 超高分子量ポリエチレン。 20.前記超高分子量ポリエチレンが実質的に耐酸化性である、請求項18に 記載の超高分子量ポリエチレン。 21.前記超高分子量ポリエチレンが3の融解ピークを有する、請求項18に 記載の超高分子量ポリエチレン。 22.前記超高分子量ポリエチレンが2の融解ピークを有する、請求項18に 記載の超高分子量ポリエチレン。 23.前記超高分子量ポリエチレンが1の融解ピークを有する、請求項18に 記載の超高分子量ポリエチレン。 24.前記超高分子量ポリエチレンが、約50%未満の結晶化度、約290Å 未満のラメラ厚みおよび約940MPa未満の引張弾性率を特徴とする独特のポ リマー構造を有する、請求項18に記載の超高分子量ポリエチレン。 25.前記超高分子量ポリエチレンが高い光透過率を有する、請求項24に記 載の超高分子量ポリエチレン。 26.前記超高分子量ポリエチレンがフィルムまたはシートであり、前記フィ ルムまたはシートが透明で且つ耐摩耗性である、請求項24に記載の超高分子量 ポリエチレン。 27.検出可能なフリーラジカルを実質的に有しない放射線処理された超高分 子量ポリエチレンから形成された二次加工品。 28.前記超高分子量ポリエチレンが架橋構造を有する、請求項26に記載の 二次加工品。 29.前記超高分子量ポリエチレンが実質的に耐酸化性である、請求項26に 記載の二次加工品。 30.前記超高分子量ポリエチレンが3の融解ピークを有する、請求項27に 記載の二次加工品。 31.前記超高分子量ポリエチレンが2の融解ピークを有する、請求項27に 記載の二次加工品。 32.前記超高分子量ポリエチレンが1の融解ピークを有する、請求項27に 記載の二次加工品。 33.前記二次加工品が、機械加工によって第2製品に形状化されうる棒材の 形である、請求項27に記載の二次加工品。 34.前記二次加工品が耐力表面を有する、請求項27に記載の二次加工品。 35.前記超高分子量ポリエチレンが、約50%未満の結晶化度、約290Å 未満のラメラ厚みおよび約940MPa未満の引張弾性率をを有するポリマー構 造を有する、請求項27に記載の二次加工品。 36.検出可能なフリーラジカルを実質的に有しない架橋超高分子量ポリエチ レンを製造する方法であって、 ポリマー鎖を有する慣用的な超高分子量ポリエチレンを提供し; 前記ポリマー鎖を架橋させるように前記超高分子量ポリエチレンに照射し; 前記照射された超高分子量ポリエチレンを、前記超高分子量ポリエチレン中に 検出可能なフリーラジカルを実質的に有しないように前記超高分子量ポリエチレ ンの融解温度を越えて加熱し;そして 前記超高分子量ポリエチレンを室温まで冷却する 工程を含む方法。 37.前記冷却された超高分子量ポリエチレンを機械加工する工程を更に含む 、請求項36に記載の方法。 38.前記機械加工された超高分子量ポリエチレンを滅菌する工程を更に含む 、請求項37に記載の方法。 39.前記提供工程における前記超高分子量ポリエチレンが、棒材、形状化さ れた棒材、コーティングおよび二次加工品から成る群より選択される、請求項3 6に記載の方法。 40.前記提供工程における前記超高分子量ポリエチレンが、プロテーゼに用 いるためのカップまたはトレー形物品である、請求項36に記載の方法。 41.前記提供工程における前記超高分子量ポリエチレンが機械加工された棒 材である、請求項36に記載の方法。 42.前記提供工程における前記超高分子量ポリエチレンが、約200万を越 える初期平均分子量を有する、請求項36に記載の方法。 43.前記提供工程における前記超高分子量ポリエチレンを、前記超高分子量 ポリエチレンの融解温度未満の温度まで予熱する、請求項36に記載の方法。 44.前記超高分子量ポリエチレンの前記予熱温度が約20℃〜約135℃で ある、請求項43に記載の方法。 45.前記超高分子量ポリエチレンの前記予熱温度が約50℃である、請求項 43に記載の方法。 46.前記予熱を非不活性環境中で行う、請求項43に記載の方法。 47.前記予熱を不活性環境中で行う、請求項43に記載の方法。 48.照射が電子照射によるものであって、前記照射からの線量率が約0.0 5〜約10Mrad/分である、請求項43に記載の方法。 49.照射が電子照射によるものであって、前記照射からの線量率が約4〜約 5Mrad/分である、請求項43に記載の方法。 50.照射が電子照射によるものであって、前記照射からの線量率が約0.0 5〜約0.2Mrad/分である、請求項43に記載の方法。 51.前記照射工程を不活性環境中で行う、請求項43に記載の方法。 52.前記照射工程を非不活性環境中で行う、請求項43に記載の方法。 53.前記提供工程における前記超高分子量ポリエチレンが、加工中に前記超 高分子量ポリエチレンからの熱損失を減少させるために断熱材中に入れてある、 請求項43に記載の方法。 54.前記照射工程の前の前記超高分子量ポリエチレンの前記予熱温度が、約 100℃〜約135℃である、請求項43に記載の方法。 55.前記照射工程の前の前記超高分子量ポリエチレンの前記予熱温度が約1 20℃である、請求項43に記載の方法。 56.前記加熱工程後の前記超高分子量ポリエチレンの最終温度が、前記超高 分子量ポリエチレンの融解温度を越える、請求項43に記載の方法。 57.前記最終温度が約140℃〜約200℃である、請求項56に記載の方 法。 58.前記最終温度が約145℃〜約190℃である、請求項56に記載の方 法。 59.前記最終温度が約150℃である、請求項56に記載の方法。 60.前記照射工程が、断熱加熱を生じるように電子照射を用いる、請求項4 3に記載の方法。 61.前記照射された超高分子量ポリエチレンの前記加熱工程が前記断熱加熱 から生じる、請求項60に記載の方法。 62.前記断熱加熱に続けて前記照射された超高分子量ポリエチレンを追加的 に加熱して、前記追加の加熱後の前記超高分子量ポリエチレンの最終温度が前記 超高分子量ポリエチレンの融解温度を越えるようにすることを更に含む、請求項 61に記載の方法。 63.前記追加の加熱後の前記超高分子量ポリエチレンの前記最終温度が約1 40℃〜約200℃である、請求項62に記載の方法。 64.前記追加の加熱後の前記超高分子量ポリエチレンの前記最終温度が約1 45℃〜約190℃である、請求項62に記載の方法。 65.前記追加の加熱後の前記超高分子量ポリエチレンの前記最終温度が約1 50℃である、請求項62に記載の方法。 66.前記電子照射の線量率が約2〜約3,000Mrad/分である、請求項6 0に記載の方法。 67.前記電子照射の線量率が約7〜約25Mrad/分である、請求項60に記 載の方法。 68.前記電子照射の線量率が約7Mrad/分である、請求項60に記載の方法 。 69.前記電子照射の総吸収線量が約1〜約100Mradである、請求項60に 記載の方法。 70.前記電子照射の総吸収線量が約22Mradである、請求項60に記載の方 法。 71.前記提供工程における前記超高分子量ポリエチレンが、室温または室温 未満である、請求項36に記載の方法。 72.前記照射工程が、断熱加熱を生じるように電子照射を用いる、請求項7 1に記載の方法。 73.前記照射された超高分子量ポリエチレンの前記加熱が前記断熱加熱から 生じる、請求項72に記載の方法。 74.前記断熱加熱に続けて前記照射された超高分子量ポリエチレンを追加的 に加熱して、前記追加の加熱後の前記超高分子量ポリエチレンの最終温度が前記 超高分子量ポリエチレンの融解温度を越えるようにすることを更に含む、請求項 73に記載の方法。 75.前記照射工程を非不活性環境中で行う、請求項36に記載の方法。 76.前記照射工程を不活性環境中で行う、請求項36に記載の方法。 77.前記照射工程が、γ線照射および電子照射から成る群より選択される照 射を用いる、請求項36に記載の方法。 78.前記照射工程が、前記超高分子量ポリエチレンを融解させる充分な熱を 生じない線量率においてである、請求項36に記載の方法。 79.前記照射工程がγ線照射を用い、そして前記γ線照射の線量率が約0. 005〜約0.2Mrad/分である、請求項36に記載の方法。 80.前記照射工程が電子線を用い、そして前記電子線の線量率が約0.05 〜約3,000Mrad/分である、請求項36に記載の方法。 81.前記照射工程からの線量率が約0.05〜約5Mrad/分である、請求項 36に記載の方法。 82.前記照射工程が電子線を用い、そしてその電子のエネルギーが約0.5 MeV〜約12MeVである、請求項36に記載の方法。 83.前記照射の総吸収線量が約0.5〜約1,000Mradである、請求項36 に記載の方法。 84.前記照射の総吸収線量が約1〜約100Mradである、請求項36に記載 の方法。 85.前記照射の総吸収線量が約4〜約3.0Mradである、請求項36に記載の 方法。 86.前記照射の総吸収線量が約20Mradである、請求項36に記載の方法。 87.前記照射の総吸収線量が約15Mradである、請求項36に記載の方法。 88.前記加熱工程の前記温度が約137℃〜約300℃である、請求項36 に記載の方法。 89.前記加熱工程の前記温度が約140℃〜約300℃である、請求項36 に記載の方法。 90.前記加熱工程の前記温度が約145℃〜約300℃である、請求項36 に記載の方法。 91.前記加熱工程の前記温度が約140℃〜約190℃である、請求項36 に記載の方法。 92.前記加熱工程の前記温度が約145℃〜約190℃である、請求項36 に記載の方法。 93.前記加熱工程の前記温度が約150℃である、請求項36に記載の方法 。 94.前記加熱工程の前記温度を約0.5分間〜約24時間維持する、請求項 36に記載の方法。 95.前記加熱工程の前記温度を約1時間〜約3時間維持する、請求項36に 記載の方法。 96.前記加熱工程を、空気、不活性ガス、増感雰囲気および真空から成る群 より選択される環境中で行う、請求項36に記載の方法。 97.前記冷却工程が、約0.1℃/分を越える速度である、請求項36に記 載の方法。 98.請求項36にしたがって製造された製品。 99.架橋した超高分子量ポリエチレンを製造する方法であって、 慣用的な超高分子量ポリエチレンを提供し; 前記超高分子量ポリエチレンを、前記超高分子量ポリエチレンの全ての結晶構 造を完全に融解させるように前記超高分子量ポリエチレンの融解温度を越えて加 熱し; 前記加熱された超高分子量ポリエチレンに照射し;そして 前記照射された超高分子量ポリエチレンを約25℃まで冷却する工程 を含む方法。 100.前記超高分子量ポリエチレンを、酸素を実質的に含まない不活性物質 で取り囲むことを更に含む、請求項99に記載の方法。 101.前記冷却された照射された超高分子量ポリエチレンが、検出可能なフ リーラジカルを実質的に有していない、請求項99に記載の方法。 102.前記提供工程における前記超高分子量ポリエチレンが、棒材、形状化 された棒材、コーティングおよび二次加工品から成る群より選択される、請求項 99に記載の方法。 103.前記提供工程における前記超高分子量ポリエチレンが、プロテーゼに 用いるためのカップまたはトレー形物品である、請求項99に記載の方法。 104.前記提供工程における前記超高分子量ポリエチレンが機械加工された 棒材である、請求項99に記載の方法。 105.前記提供工程における前記超高分子量ポリエチレンが、約200万を 越える初期平均分子量を有する、請求項99に記載の方法。 106.前記加熱工程における前記温度が約145℃〜約230℃である、請 求項99に記載の方法。 107.前記加熱工程における前記温度が約175℃〜約200℃である、請 求項99に記載の方法。 108.前記加熱工程における前記温度を約5分間〜約3時間維持する、請求 項99に記載の方法。 109.前記照射工程が、γ線照射および電子照射から成る群より選択される 照射を用いる、請求項99に記載の方法。 110.前記照射工程が、前記加熱された超高分子量ポリエチレンに約1MRad を越える線量を与える、請求項99に記載の方法。 111.前記冷却工程が、約0.5℃/分を越える速度である、請求項99に 記載の方法。 112.前記冷却された超高分子量ポリエチレンを機械加工する工程を更に含 む、請求項99に記載の方法。 113.請求項99にしたがって製造された製品。 114.高度に絡み合って架橋した超高分子量ポリエチレンを製造する方法で あって、 慣用的な超高分子量ポリエチレンを提供し; 前記超高分子量ポリエチレンを、前記超高分子量ポリエチレンの融解温度を越 えて、前記超高分子量ポリエチレン中で絡み合ったポリマー鎖の生成を可能にす る充分な時間加熱し; 前記加熱された超高分子量ポリエチレンを、そのポリマー鎖を絡み合った状態 に止めるために照射し;そして 前記照射された超高分子量ポリエチレンを約25℃まで冷却する工程 を含む方法。 115.前記超高分子量ポリエチレンを、酸素を実質的に含まない不活性物質 で取り囲むことを更に含む、請求項114に記載の方法。 116.請求項114にしたがって製造された製品。 117.検出可能なフリーラジカルを実質的に有しない放射線処理された超高 分子量ポリエチレンから医療用プロテーゼを製造する方法であって、前記プロテ ーゼが前記プロテーゼの装着中の前記プロテーゼからの粒子の生成を減少させる ものであり、 検出可能なフリーラジカルを有しない放射線処理された超高分子量ポリエチレ ンを提供し; 前記プロテーゼの装着中の前記プロテーゼからの粒子の生成を減少させるよう に前記超高分子量ポリエチレンから医療用プロテーゼを形成し、前記超高分子量 ポリエチレンが前記プロテーゼの耐力表面を形成すること を含む方法。 118.前記超高分子量ポリエチレンが、約50%未満の結晶化度、約290 Å未満のラメラ厚みおよび約940MPa未満の引張弾性率を有するポリマー構 造を有する、請求項117に記載の方法。 119.医療用プロテーゼを必要とする身体を治療する方法であって、 検出可能なフリーラジカルを実質的に有しない放射線処理された超高分子量ポ リエチレンから形成された形状化された医療用プロテーゼを提供し;そして 前記プロテーゼを、前記プロテーゼを必要とする前記身体に適用することを含 む方法。 120.前記超高分子量ポリエチレンが、約50%未満の結晶化度、約290 Å未満のラメラ厚みおよび約940MPa未満の引張弾性率を有するポリマー構 造を有する、請求項119に記載の方法。 121.前記超高分子量ポリエチレンが3の融解ピークを有する、請求項11 9に記載の方法。 122.前記超高分子量ポリエチレンが2の融解ピークを有する、請求項11 9に記載の方法。 123.前記超高分子量ポリエチレンが1の融解ピークを有する、請求項11 9に記載の方法。
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US74496P | 1996-02-13 | 1996-02-13 | |
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US72631396A | 1996-10-02 | 1996-10-02 | |
US08/726,313 | 1996-10-02 | ||
PCT/US1997/002220 WO1997029793A1 (en) | 1996-02-13 | 1997-02-11 | Radiation and melt treated ultra high molecular weight polyethylene prosthetic devices |
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Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000033117A (ja) * | 1998-06-10 | 2000-02-02 | Depuy Orthopaedics Inc | 架橋成形したプラスチック支持体 |
JP2001070435A (ja) * | 1999-07-29 | 2001-03-21 | Depuy Orthopaedics Inc | プロテーゼ部品および製造方法 |
JP2004524900A (ja) * | 2001-02-23 | 2004-08-19 | スミス アンド ネフュー インコーポレーテッド | 医療用インプラントで使用される架橋された超高分子量ポリエチレン |
JP2008500116A (ja) * | 2004-05-27 | 2008-01-10 | アドヴァンスド カーディオヴァスキュラー システムズ, インコーポレイテッド | 埋め込み型医療デバイスの熱処理 |
JP2008534123A (ja) * | 2005-03-31 | 2008-08-28 | ジンマー,インコーポレイティド | 整形外科インプラント用の高分子材料の液体浴アニーリング |
JP2008208381A (ja) * | 2002-01-04 | 2008-09-11 | Massachusetts General Hospital | 溶融体を下回る温度で調製した残留フリーラジカルが減少した高弾性率架橋ポリエチレン |
JP2008543433A (ja) * | 2005-06-14 | 2008-12-04 | オムニ ライフ サイエンス, インク. | 交差結合したポリエチレン粒子 |
JP2011503253A (ja) * | 2007-11-06 | 2011-01-27 | ディーエスエム アイピー アセッツ ビー.ブイ. | (超)高分子量ポリエチレンの生産方法 |
-
1997
- 1997-02-11 JP JP52945997A patent/JP4752039B2/ja not_active Expired - Lifetime
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000033117A (ja) * | 1998-06-10 | 2000-02-02 | Depuy Orthopaedics Inc | 架橋成形したプラスチック支持体 |
JP2001070435A (ja) * | 1999-07-29 | 2001-03-21 | Depuy Orthopaedics Inc | プロテーゼ部品および製造方法 |
JP2004524900A (ja) * | 2001-02-23 | 2004-08-19 | スミス アンド ネフュー インコーポレーテッド | 医療用インプラントで使用される架橋された超高分子量ポリエチレン |
JP2010088908A (ja) * | 2001-02-23 | 2010-04-22 | Smith & Nephew Inc | 医療用インプラントで使用される架橋された超高分子量ポリエチレン |
JP2008208381A (ja) * | 2002-01-04 | 2008-09-11 | Massachusetts General Hospital | 溶融体を下回る温度で調製した残留フリーラジカルが減少した高弾性率架橋ポリエチレン |
JP2008500116A (ja) * | 2004-05-27 | 2008-01-10 | アドヴァンスド カーディオヴァスキュラー システムズ, インコーポレイテッド | 埋め込み型医療デバイスの熱処理 |
JP2008534123A (ja) * | 2005-03-31 | 2008-08-28 | ジンマー,インコーポレイティド | 整形外科インプラント用の高分子材料の液体浴アニーリング |
JP2008543433A (ja) * | 2005-06-14 | 2008-12-04 | オムニ ライフ サイエンス, インク. | 交差結合したポリエチレン粒子 |
JP2011503253A (ja) * | 2007-11-06 | 2011-01-27 | ディーエスエム アイピー アセッツ ビー.ブイ. | (超)高分子量ポリエチレンの生産方法 |
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