JP2021526911A - 生体適合性、熱及びγ線安定性の医療デバイス用潤滑剤及び腐食防止剤 - Google Patents
生体適合性、熱及びγ線安定性の医療デバイス用潤滑剤及び腐食防止剤 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00836—Material properties corrosion-resistant
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/10—Materials for lubricating medical devices
Abstract
Description
ポリフェニルエーテル 3つのTOCバイアルのそれぞれに30mL
65−BLA−11−1 12.7mmの縦溝付きドラム それぞれ20個。
細胞毒性評価
細胞毒性評価試験マトリックスを以下に示す。
皮内刺激性試験
皮内刺激性試験を実施して、PPEが試験サンプルから浸出する又は抽出され、白色ウサギの皮膚組織に局所的な刺激を引き起こすかどうかを判定した。試験サンプルを、ゴマ油を用いて1:1の比で希釈した。各動物を秤量し、試験注射前の重量を記録した。動物の毛を脊柱の両側で刈り取って、注射のための十分な大きさの領域を露出させた。
モルモットマキシマイゼーション法による感作試験
PPEを含有する試験物品のアレルゲン可能性又は増感能力を評価するための試験を実施した。この試験を、モルモットにおける接触アレルゲンのスクリーニングのための手順として使用し、ヒトへの結果を推定した。
急性全身性注射試験
マウスにおける単回投与全身性注射の結果としての潜在的な毒性効果についてPPEを含有する試験物品溶液をスクリーニングするために、急性全身性注射試験を実施した。
定性的分子組成評価(FTIR)
腐食防止評価
非滅菌の状態及びガンマ滅菌済みの状態の防食剤が非細胞毒性であることを確立した後、PPEの腐食防止特性を評価した。
(1) 外科患者と接触するように構成された金属表面と、前記金属表面上の生体適合性ポリマーコーティングと、を備え、前記ポリマーコーティングがポリフェニルエーテルポリマーを含み、前記コーティングが、保管中に前記金属表面の腐食速度を遅らせる、外科用器具。
(2) 前記ポリフェニルエーテルポリマーが、6環ポリフェニルエーテルポリマー、5環ポリフェニルエーテルポリマー、4環ポリフェニルエーテルポリマー、3環及び4環オキシ−及びチオエーテルポリマー、3環ポリフェニルエーテルポリマー、2環ジフェニルエーテルポリマー、又はこれらの組み合わせからなる群から選択される、実施態様1に記載の外科用器具。
(3) 前記ポリフェニルエーテルポリマーが、5環ポリフェニルエーテルポリマーである、実施態様2に記載の外科用器具。
(4) 前記金属表面が、ステンレス鋼、チタン若しくはチタン合金、鉄−ニッケル合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される金属合金を含む、実施態様1に記載の外科用器具。
(5) 前記金属合金が、ステンレス鋼合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される、実施態様4に記載の外科用器具。
(7) 前記ポリマーコーティングが、ガンマ線による劣化に耐性がある、実施態様1に記載の外科用器具。
(8) 前記器具が、切断用器具又は関節運動器具である、実施態様1に記載の外科用器具。
(9) 前記外科用器具が、無菌又は非無菌のいずれかである、実施態様1に記載の外科用器具。
(10) 前記外科用器具が無菌である、実施態様9に記載の外科用器具。
(12) 前記ポリフェニルエーテルポリマーが、6環ポリフェニルエーテルポリマー、5環ポリフェニルエーテルポリマー、4環ポリフェニルエーテルポリマー、3環及び4環オキシ−及びチオエーテルポリマー、3環ポリフォニーエーテルポリマー、2環ジフェニルエーテルポリマー、又はこれらの組み合わせからなる群から選択される、実施態様11に記載の方法。
(13) 前記ポリフェニルエーテルポリマーが、5環ポリフェニルエーテルポリマーである、実施態様12に記載の方法。
(14) 前記金属表面が、ステンレス鋼、チタン若しくはチタン合金、鉄−ニッケル合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される金属合金を含む、実施態様11に記載の方法。
(15) 前記金属合金が、ステンレス鋼合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される、実施態様14に記載の方法。
(17) 前記ポリマーコーティングが、ガンマ線による劣化に耐性がある、実施態様11に記載の方法。
(18) 前記外科用器具が、切断用器具又は関節運動器具である、実施態様11に記載の方法。
(19) 前記外科用器具が、無菌又は非無菌のいずれかである、実施態様11に記載の方法。
(20) 前記外科用器具が無菌である、実施態様19に記載の方法。
Claims (20)
- 外科患者と接触するように構成された金属表面と、前記金属表面上の生体適合性ポリマーコーティングと、を備え、前記ポリマーコーティングがポリフェニルエーテルポリマーを含み、前記コーティングが、保管中に前記金属表面の腐食速度を遅らせる、外科用器具。
- 前記ポリフェニルエーテルポリマーが、6環ポリフェニルエーテルポリマー、5環ポリフェニルエーテルポリマー、4環ポリフェニルエーテルポリマー、3環及び4環オキシ−及びチオエーテルポリマー、3環ポリフェニルエーテルポリマー、2環ジフェニルエーテルポリマー、又はこれらの組み合わせからなる群から選択される、請求項1に記載の外科用器具。
- 前記ポリフェニルエーテルポリマーが、5環ポリフェニルエーテルポリマーである、請求項2に記載の外科用器具。
- 前記金属表面が、ステンレス鋼、チタン若しくはチタン合金、鉄−ニッケル合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される金属合金を含む、請求項1に記載の外科用器具。
- 前記金属合金が、ステンレス鋼合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される、請求項4に記載の外科用器具。
- 前記金属合金がM2モリブデン合金を含む、請求項5に記載の外科用器具。
- 前記ポリマーコーティングが、ガンマ線による劣化に耐性がある、請求項1に記載の外科用器具。
- 前記器具が、切断用器具又は関節運動器具である、請求項1に記載の外科用器具。
- 前記外科用器具が、無菌又は非無菌のいずれかである、請求項1に記載の外科用器具。
- 前記外科用器具が無菌である、請求項9に記載の外科用器具。
- 耐食性を改善するために外科用器具の金属表面を処理する方法であって、前記方法が、前記金属表面を生体適合性ポリマーコーティングでコーティングすることを含み、前記ポリマーコーティングがポリフェニルエーテルポリマーを含む、方法。
- 前記ポリフェニルエーテルポリマーが、6環ポリフェニルエーテルポリマー、5環ポリフェニルエーテルポリマー、4環ポリフェニルエーテルポリマー、3環及び4環オキシ−及びチオエーテルポリマー、3環ポリフォニーエーテルポリマー、2環ジフェニルエーテルポリマー、又はこれらの組み合わせからなる群から選択される、請求項11に記載の方法。
- 前記ポリフェニルエーテルポリマーが、5環ポリフェニルエーテルポリマーである、請求項12に記載の方法。
- 前記金属表面が、ステンレス鋼、チタン若しくはチタン合金、鉄−ニッケル合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される金属合金を含む、請求項11に記載の方法。
- 前記金属合金が、ステンレス鋼合金、モリブデン合金、又はこれらの組み合わせからなる群から選択される、請求項14に記載の方法。
- 前記金属合金がM2モリブデン合金を含む、請求項15に記載の方法。
- 前記ポリマーコーティングが、ガンマ線による劣化に耐性がある、請求項11に記載の方法。
- 前記外科用器具が、切断用器具又は関節運動器具である、請求項11に記載の方法。
- 前記外科用器具が、無菌又は非無菌のいずれかである、請求項11に記載の方法。
- 前記外科用器具が無菌である、請求項19に記載の方法。
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JP2009530024A (ja) * | 2006-03-22 | 2009-08-27 | ボストン サイエンティフィック リミテッド | 生分解性金属インプラント用の耐腐食コーティング |
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WO1998053922A1 (en) * | 1997-05-27 | 1998-12-03 | Polymer Alloys Llc | Metal corrosion protection with wash coat of polyphenylene oxide |
US6545097B2 (en) * | 2000-12-12 | 2003-04-08 | Scimed Life Systems, Inc. | Drug delivery compositions and medical devices containing block copolymer |
US7905902B2 (en) * | 2003-06-16 | 2011-03-15 | Ethicon Endo-Surgery, Inc. | Surgical implant with preferential corrosion zone |
DE102004034645A1 (de) * | 2004-07-16 | 2006-02-09 | Ewald Dörken Ag | Korrosionsschutz-Beschichtungsmittel für Metall und Verfahren zur Herstellung hierfür |
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