TW298565B - - Google Patents
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- TW298565B TW298565B TW083109525A TW83109525A TW298565B TW 298565 B TW298565 B TW 298565B TW 083109525 A TW083109525 A TW 083109525A TW 83109525 A TW83109525 A TW 83109525A TW 298565 B TW298565 B TW 298565B
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- Taiwan
- Prior art keywords
- bioabsorbable
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- patent application
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- gel
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/1146—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of tendons
-
- 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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
-
- 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
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
- A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30224—Three-dimensional shapes cylindrical
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30291—Three-dimensional shapes spirally-coiled, i.e. having a 2D spiral cross-section
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30291—Three-dimensional shapes spirally-coiled, i.e. having a 2D spiral cross-section
- A61F2002/30293—Cylindrical body made by spirally rolling up a sheet or a strip around itself
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30971—Laminates, i.e. layered products
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
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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
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
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- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Surgery (AREA)
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- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
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- Composite Materials (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rehabilitation Therapy (AREA)
- Cardiology (AREA)
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- Prostheses (AREA)
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Description
A7 A7 經濟部中央梂準局員工消费合作社印11 五、發明説明— 本發明係有關一種可吸收性結構,作爲暫時性補缺器使 用,供修補受傷之韌帶與/或腱。 物帶與/或腱經常受傷,尤其常發生在激烈運動或接觸 &運動時,一種特别常見但很難治療之運動傷害爲膝蓋前 十字形韌帶(ACL)之裂傷。 過去曾嘗試許多不同方法來恢復裂傷之腱或韌帶之功能 。最簡單的方法爲缝合韌帶或腱之裂端。然而,依此方 式縫合之韌帶或腱之癒合速率非常慢且甚至在完全癒合 後,動帶或腱之強度大幅度地減弱。此外,結疤組織容易 增殖至周園組織中,造成不舒服及喪失可動性。 另一種方法,以一種由生物可相容性但無法吸收之材質 如:Dacron®,ΡΤΕΕ或聚丙烯製成永久性補缺器替代韌帶 與鍵。一種較受歡迎之永久性補缺器係由成束之碳纖維組 成’可視需要包覆一種生物可相容性聚合物。然而,沒有 一種永久性補缺器經證明可充份地耐久,爲使用者終生替 代勒帶或腱。特定言之,已發現以碳纖維爲主之補缺器 在使用12至18個月後容易斷裂,因此會釋出碳粒子,可能 導致嚴重發炎反應,甚至發生關節炎。 另一種修補受傷之腱或韌帶之方法爲植入一種暫時性, 生物可分解之補缺器,可固定腱或韌帶並作爲腱或勃帶 之备癒骨架,同時逐漸被身體吸收。因此,這種暫時性補 缺器之要求條件包括:高抗張強度以恢復腱或韌帶功能, 在原位缓慢但完全之生物可吸收性,低抗原性,及定向( 單轴向)結構,以便由腱或韌帶之未受傷末端之織維母細 -3 - 本紙張尺度逋用中困國家標準(CNS ) A4規格(2丨Οχ297公董) 一 ▲------ir-----^ 線 (請先閲讀背面之注意事項再填寫本頁) 經濟部中央橾準局員工消費合作社印裝 A7 * ____________B7 五、發明説明(2 ) 一'〜' 胞疋向進入生長,促進形成強力且取向良好之結宛組織。 / 85/00511説明一種以膠原爲主之材質,可供再生勃 、與/或腱。該材質係由與戊二敎鏈以提高其抗張強度 之膠原成股形成,成股之膠原係呈合適之編織形式,股與 股之間有足^空間,可提供作爲"台架,,之功能,初帶之織 維母細胞可藉此增殖。一片膠原編織物可捲成具螺旋橫斷 面之圓柱,位在例如:裂傷之前十字形動帶之末端之間, 圓柱末端與勒帶未受傷末端缝合。關節係固定,且動帶之 療合據稱在三週内即已完全。 同樣地,US-A-5171273説明由高強度之膠原纖維形成之 可吸收性韌帶或腱補缺器。高強度膠原纖維之形成步骤如 下·使I型膠原溶於稀HC1中,將溶液擠|至特定之缓衝 液槽中,再组成膠原纖維,並使用戊二醛或併用嚴重之脱 水作用與胺基氰之處理,使再組成之纖維交鏈。纖維經過 編織,检捲或編成穗,形成可吸收之勃帶與/或腱補缺器。 腱與/或韌帶補缺器之缺點爲僅由膠原形成即使依上 述經過交鏈,也會在活體内迅速喪失膠原之抗張強度。膠 原這種特性無法與修補韌帶或腱所需之相當長癒合時間配 合。 W0 88/06872説明一種修補膜或動帶之可植入式補缺器 ,其特徵爲其結構爲不同於蛋白質或多丨太或其衍生物之生 物可吸收性材質。該結構具有縱向凹溝或通可作爲新 纖維組織之最初增殖引道。例如:補缺器可由許多合成之 生物可吸收性聚合物,如:乳酸與m基乙酸之共聚物聚 本紙张尺度適用中固國家樣牟(CNS ) A4規格(210X297公瘦) ^ -裝------訂-----(線 (請先聞讀背面之注意Ϋ項再填寫本萸) 經濟部中央標準局貝工消費合作社印製 29δ565 λ7 --____Β7 五、發明説明(3 ) 經基丁酸,等等之同心圓小管組成。小管之間的空隙則成 爲組織進入生長之縱向通道。
Ep-A-〇241252説明一種可吸收性韌帶或腱補缺器,係由 具有特别高抗張強度之特殊末端封端之丙交g旨聚合物之熔 融餘絲形成。絲線經過摺疊,捻捲或編穗,形成韌帶或腱 補缺器,捻捲或編穗過程提供一種相當開放之結構,在幾 何上可使天然組織沿著絲線沈積,發展成天然腱或韌帶組 織。 上述僅以合成之非膠原性聚合物爲主之可吸收性補缺器 之缺點爲該補缺器無法具有生物聚合物(如:膠原)之有利 的傷口癒合性質。已知傷口癒合細胞(如:纖維母細胞)對 膠原及某些其他生物聚合物具有特殊親和力。這種性質稱 爲膠原之向化效應。 上述所有可吸收性腱與/或韌帶補缺器之另一個缺點爲 補缺器讓纖維母細胞進入之多孔性並不適當。經過測定發 現,可促進細胞進入之較佳孔或通道大小範圍爲50-250微 米,但迄今之植入材質均未提供在此範圍内之控制孔率。 因此,本發明之一項目的爲提供生物可完全吸收之韌帶 與/或腱補缺器,可結合高抗張強度,向化性質及最適當 孔性,供細胞之定向進入及療合。 本發明提供一種包含下列螺旋層,而呈多層螺旋捲形式 之生物可吸收性韌帶或腱補缺器:合成之生物可吸收性材 質之多孔層,生物可吸收性膜,及一層生物可吸收性海綿。 根據本發明之補缺器係呈多層螺旋捲形式,亦已知爲" 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) ------ --------< -^.------1T-----~ 線 (請先閲讀背面之注意事項再填寫本頁) A7 B7 五、發明説明(4 ) 經濟部中央橾準局員工消费合作社印裝 瑞士捲"結構,意即,補缺關由許多重4層捲成圓柱捲 而形成。各層藉此與其他層呈_心且放射狀交替排列捲 成螺旋捲。 螺旋捲之較佳直徑範園爲12至21毫米,以3 〇至1〇 〇毫 米更佳。螺旋捲之較佳長度爲5至80毫米。螺旋捲包含2 至6個完全360。旋轉之螺旋較佳。 合成之生物可吸收性材質之多孔層主要功能爲提供補缺 器之抗張強度。這一層之多孔性質加強了補缺器之撓性, 並使得補缺器容易缝合。多孔層爲編織性,非織性或編結 性篩網較佳。 較佳者,多孔層包含乳酸或羥基乙酸之聚合物或共聚物 ,氧化再生之纖維素,聚二垮烷酮(?〇1丫(1丨(^31101^)(?1)5), 乳酸與ε_己内醯胺之共聚物,聚羥基丁酸或m基丁酸與 羥基戊酸之共聚物。更佳者,多孔層包含<種以註册商標 名稱VICRYL出售之乳酸與羥基乙酸之共聚物,或以註册商 標名稱SURGICEL出售之氧化再生性纖維素。更佳者,多孔 層包含EP-A-0241252所述之熔融紡織之聚丙交醏或聚丙交 醏/聚乙交酯共聚物。 多孔層不一定要與連續膜層或海綿層鍵結。然而,較佳 者爲多孔層與膜層或海绵層中之一或二者鍵結,且更佳者 爲多孔層實際上包埋在膜層或海綿層中之一層内,下文中 有進一步説明。 多孔層之最大厚度範固在0.02至0.3毫米之間較佳,以 0.04至0.1毫米更佳。 本紙張尺度適用中國國家橾準(CNS ) A4現格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁) —裝· 訂 線 經濟部中央棵準局貝工消費合作社印装 A7 """' — ---- -- B7_________________ 五、發明説明(5) 生物可吸收性膜爲一種生物可吸收性材質之連績式或實 質上呈連續式之膜層,可阻斷細胞在捕缺器内部呈放射方 ,移動。意即,生物可吸收性膜之屏障層可引導細胞沿 著補缺器軸向移動,形成取向良好且強力之替代組織,生 物可吸收性膜之較佳形成法爲使含有生物聚合物如:膠原 ,聚葡糖胺如:玻尿酸,等等之水性溶液或懸浮液乾燥。 生物可吸收性膜中含有一種生物可吸收性增塑劑較佳。較 佳之增塑劑爲多元醇,如:甘油,且其較佳含量爲5%至 50% W/W。 生物聚合物呈交鏈較佳,以降低其生物吸收速率。較 佳交鏈劑包括醛類如:戊二醛,異氰酸酯及碳化二亞胺。 生物聚合物膜最好亦包含油微滴液勻散在其中以便進一 步降低生物吸收速率。油微滴液可包含任何生物可相容性 及生物可吸收性油,如:葵花籽油芝麻籽油或魚油。油 之較佳含量佔生物聚合物膜重量之丨至9〇重量%,以1〇至 75重量%更佳。 ’ 多孔層實際上經生物可聚合性膜塗佈或包埋在其中因 此多孔層中之空隙實質上已填充生物可吸收性膜之材質。 特别佳之複合材質包括一種包埋在膠原膜中之加強性篩網 ,其於ΕΡ-Α-0 194 192中已有説明且申請專利。 生物可吸收性膜(當其與多孔層形成複合物時除外)之厚 度範圍爲0.01-0.1毫米較佳,以0.015-0.03毫米更佳。子 生物可吸收性生物聚合物海錦層作爲加強層與生物^吸 收性膜之螺旋圈之間之間隔物,作爲限制細胞進入之均— 本紙张尺度逋用中國國家榡準(CNS )六4見格(210X297公釐) i------、玎-----1 線 (請先聞讀背面之注意事項再填寫本頁) 經濟部中央樣準局貝工消費合作社印製 A7 B7 五、發明説明(6 ) 且定向之間隙通道。海綿之孔性及生物聚合物之甸化效應 之組合可促進纖維母細胞迅速進入,使組織快速於生。較 佳者,海綿包含膠原,聚葡糖胺如:軟骨素硫酸殲戒玻尿 酸或此等生物聚合物之混合物。海綿之孔性最好調裘最佳 程度,以使細胞進入生長達最大程度,此表示至少80%的 孔平均孔直徑範園在50微米-250微米。要得到遑種相當小 孔徑可利用例如:膠原溶液或懸浮液之急速冷凍(造成極 小型冰晶),然後冷凍乾燥,如wo 90/00060中所述。或 者或另外可在凝膠中包含一種揮發性防凍劑如:乙醇或異 丙醇,防陳劑含量爲5-25% W/V較佳,即可得到小孔徑 。防來劑之存在可使冷涞時形成較小冰晶,因此冷床乾燥 時得到較小孔徑。 海綿中除了結構性生物聚合物外,尚包含化學醫療劑。 例如:海綿可包含消毒劑或抗生素。海綿中最好包含傷口 癒合因子如:生長因子,細胞素藻酸鹽,聚葡糖胺或其 活性衍生物,生物可吸收性膜或者或另外可包含相同或相 異之醫療劑。 海綿之結構性生物聚合最好交鏈,以降低海綿之生物吸 收速率。結構性生物聚合物爲膠原較佳,且交鏈劑爲上述 生物可吸收性膜所使用之一種交鏈劑。亦較佳者,生物聚 合物海綿中包含佔海綿重量1至9〇重量%較佳佔至75 重量%更佳之油微滴液勻散其中。該油可爲任何生物可相 谷且生物可分解之油,如:葵花籽油芝麻籽油或魚油。 油微滴液之存在可以大量降低海綿之生物吸收速率:此外 I — I n 11 ""/ — 裝 訂 一 線 (請先閱讀背面之注意事項再填寫本頁)
經濟部中央標準局貞工消費合作社印製 A7 B7 五、發明説明(7 ) ,可使用油微滴液作爲疏水性,親油性醫療劑之載劑。 海綿層之較佳厚度範圍爲0.5至2.5毫米,以1 .〇至1.5毫 米更佳。 較佳者,海綿層包埋一個或多個縱向延伸在部份或整個 補缺器中之固體生物可吸收性圓桿。該等圓桿可爲生物可 吸收性缝線之節段,以膠原縫線較佳。圓桿可加強海綿層 之單轴定向性,並降低活體内吸收海綿層之速率。 本發明亦提供以如上述生物可吸收性補缺器製備修補受 傷之腱或韌帶用之手術植入物之方法。 本發明尚提供一種製造一種生物可吸收性補缺器,供用 於手術修補受傷之韌帶或腱之方法,該方法包括下列步驟 :由生物可吸收性材質之多孔層與生物可吸收性膜形成層 壓層;在層壓層上塗佈一層包含生物可吸收性聚合物之水 性凝膠;捲起層壓層並將凝膠層捲入螺旋捲中,然後乾燥 凝膠,形成生物可吸收性海綿層。 較佳者,利用冷凍法(以急速冷凍法較佳)乾燥凝膠,形 成生物可吸收性海綿後,冷凍乾燥,於減壓下蒸發凝膠中 之水。另一種較佳方法爲凝膠冷凍或急速冷凍,凍結之凝 膠經吸濕性溶劑如:異丙醇處理,進行溶劑乾燥法。 層壓層包含生物可吸收性材質之多孔層與生物可吸收性 膜之重番層。較佳者,層壓層包含高抗張強度之多孔篩網 包埋在一種生物聚合物(如:膠原)之膜層中,如:Ep-A-0194192 所述。 多孔層與生物可吸收性膜之組成份可以相同或相異且 本紙張尺度適用中國國家揉準(CNS > A4说格(210X297公嫠) (請先聞讀背面之注意事項再填寫本頁) 訂 五、發明説明(8 ) A7 B7 經濟部中央標準局貝工消費合作社印製 ί好如上述本發明腱—_缺器之齡具財施例之定 義0 :者2性凝膠包含經酸膨脹之膠原纖維,其較佳浪 。 % W/V,較佳方法中,依US-A-4614794或 〇3八432〇201中所述,自牛眞皮或腱中萃取纖維性膠原, 並預洗去社彡數轉魏錢。膠雜㈣浮在乾淨之 去離子化無熱原之水中,通過均質化系統使之均勻形成均 細I纖維懸祕。合適之㈣化系統述於US A_432〇2〇i。 均質化作用雜續it行到達歧需纖維分割程度時爲止 。此舉造成較佳纖維大小範圍在〇 〇1至1〇毫米。 ”均質化之獅㈣酸化,使之_,並形成適合冷來乾 燥,凝膠。酸化步驟可使用有機酸如··甲酸,乙酸,丙酸 ,乳酸或丙二醇。或稀無機酸如:鹽酸。均之 浮液最好酸化至pH2至6,以邱3.〇至4 5更佳。 懸 化學醫療劑(如上述者較佳)可句散在生物可吸收性聚合 物之水性凝膠中,其用量佔海綿乾重0.1%至50% Ψ/W較 佳。亦較佳者,生物可吸收性油之微滴液可在高切變下乳 化(膠原爲有效之乳化劑)而勻散在水性凝膠中。油微滴液 之較佳含量佔海綿乾重1至90重量%,以1〇至75重量%更 佳0 較佳者,水性凝膠在-20·〇以下之溫度進行急速冷凍後 ’冷來乾燥,依WO 90/00060所述進行較佳。急速冷米法 造成較小型冰晶 因此爲冷凍乾燥之海綿提供較小的孔 徑。水性凝膠在冷凍前添加揮發性防凍劑如:乙醇或異丙 -10- (請先閎讀背面之注意事項再填寫本頁} -裝 訂 線 本紙張^逍用中關家縣(CNS ) A4胁(21GX297公羡) 經濟部中央梂準局貞工消费合作社印ίι A7 --------... B7 五、發明説明(9 ) " -- 醇二亦可降低冷絲燥後之料孔徑大小因爲這些物質 亦谷易降低冷树所形成冰晶之大小。_物質之添加量 佔凝膠體積5-25% W/V。 =仃冷料燥步驟時,較佳方式爲減在紐下蒸發冷 床凝膠中之水(及其他揮發性成份),或採麟難燥法, 其涉及以一種吸濕性溶劑如:異丙醇,處理冷凍凝膠萃 取冷來凝膠中之水。已驚人地發現,冷; 東凝膠中舍有揮發 性防凍劑如:乙醇或異丙醇時可加速溶劑乾燥作用。 較佳者,在乾燥之前,將覆上水性凝膠層之層壓層捲 成2至6個完全360。旋轉。水性凝膠可預先冷卻至〇。_ 5C,然後才進行捲起步驟,以增加凝膠堅固性,並減少 圓捲末端擠出之凝膠流失量。開始捲起步驟時最好繞著 一個小直徑之圓軸(例如:注射針)捲起待完全捲起後再 除掉,可使用稍過量之水性凝膠(至多超過5〇%)來彌補捲 起步驟中流失之凝膠量。 根據本發明其他較佳方法中,在層壓層上放置一個或多 個生物可吸收性圓桿,與層壓層所捲起之軸向平行。生物 可吸收性圓桿爲生物可吸收性缝線節段較佳,且包含膠原 較佳。圓桿有助於確使乾燥後之補缺器中之海綿層保持均 一厚度。 另一項較佳具體實施例中,根據本發明方法尚可包括乾 燥之補缺器先在活體外與宿主細胞如:宿主滑膜細胞或宿 主纖維母細胞培養後再植入之步驟。甚至可將細胞注射至 補缺器主體内。經過一段合適時間在補缺器中達到所需細 -11- n u , TJ ▲ I — (請先閲讀背面之注意事項再填寫本頁) 訂 線 本紙張尺度適用中國國家橾準(CNS>A4说格(210X297公釐) ' — _ A7 ________B7____ 五、發明説明(10 ) 胞生長及繁殖後,可將此結構植入體内。 本發明之腱或韌帶補缺器之明確具體實施例將參考附圖 舉例進一步説明。 圖1出示根據本發明之生物可吸收性補缺器之橫斷面。 圖2出示製造圖1之生物可吸收性補缺器之方法。 圖3出示圖1之生物可吸收性補缺器用於修補嚴重受傷 之動帶。 圖1中,補缺器1包括一種多層螺旋捲,係由合成之生 物可吸收性材質之多孔層2,生物可吸收性膜3及生物可 吸收性海綿層4組成。多孔層2係由以註册商標名稱 VICRYL出售之聚丙交酯/聚乙交酯篩網組成。生物可吸收 性膜3係由〖型膠原纖維與六亞甲基二異氰酸酯交鏈組成 。海綿層4亦由I型膠原纖維與六亞甲基二異氰酸酯交鏈 組成。 應用時,使用補缺器替代一部份或所有受傷之韌帶或腱 ,如圖3所示,補缺器之末端5,6與韌帶或腱之未受傷末 端7,8缝合。或者,補缺器末端5,6之一可直接附接骨頭 上或嵌入骨中之窩孔。 經濟部中央梂準爲負工消费合作社印«. --------/ -裝— (請先閲讀背面之注意事項再填寫本頁) 線 圖3亦利用箭頭圖解説明細胞由韌帶或腱之未受傷末端 7,8移動及組織生長進入補缺器1中之方向。由於膠原海 、綿之孔性及膠原之向化效應,使得細胞,尤指纖維母細胞 迅速移動至膠原海綿内。然而,由於膠原海綿螺旋層4限 定細胞往縱向通道上移動因此細胞之移動具高度地定向 性。放射狀之細胞移動會受到生物可吸收膜層3之阻斷。 -12~ t 2 ,-·^π--—— vicm筛網層2爲補缺器提供了必要之抗張強度, 同時保 留了可缝合性。 下列實例將進-步說明根據本發明補缺器製法之明確具 體實施例: 實例1 根據本發明供韌帶或腱使用之補缺器包含下列分開層: 多孔性口成之生物可吸收性聚合物,生物可吸收性膜及 生物可吸收性海綿,其製法如下: A ·膠原漿物之舉借 依US-A-4614794或US~A-侧201所述,自牛眞皮取得織 維性膠原,先預洗去除大多數非膠原,成份依0.45% w/v 4濃度懸浮在乾淨之去離子化無減水巾,通軸似仍] 4320201所述之均質化系統,均質化形成均細之織維性懸 ㈣°繼_質化直到膠原纖維大小在0.1-1.0毫米之範 圍内爲止。以乙酸酸化懸浮液至PH 4.5,使膠原膨脹。 B·膠原膜層士 f让 經濟部中央梂準局貝工消費合作社印衷 添加作爲增鋪之甘油至上述步驟A所製備之膠原凝膠 ,終重量爲0.5% w/w,然後在—個具有不沾點表面(例 t:PTFE)之平盤上塗佈凝膠,至厚度約2毫米。凝膠隨後 在熱風中乾燥,留下厚約0·02毫米之連續且挽性之膠原 膜。 八 c · n曼之製法 取一g規格约20毫米Χ 40毫米><〇.!毫米之長方形 VICRYL®聚丙交醋/聚乙交酯篩網置入平底盤中。取一片 ~ 13 - A7 B7 經濟部中央榡準局貝工消費合作社印製 i、發明説明(12 ) 同樣大小形狀之步驟B所製備之膠原膜置於VICRYL篩網上 面。 D.補缺器之Μ法 在步驟C所製得層壓層之上表面塗佈深約1-2毫米之步 驟Α所製備膠原凝膠層,但其中含有0.5% w/v膠原固體 與10% w/v異丙醇,最終pH爲4.5。凝膠迅速脱氣,覆有 凝膠層之層壓層則迅速但小心地沿著長方形之長邊捲起。 所得到之螺旋環依W0 90/00060所述急速冷凍後,冷凍乾 燥,製成補缺器。所製成之膠原海綿層中,至少80%小孔 之平均孔大小範圍爲35至250微米,已接近最適合細胞進 入之大小。 實例2 依下列方法製備根據本發明修補韌帶或腱之補缺器,其 中多孔性合成之生物可吸收層係包埋在生物可吸收性膜 中: 首先,依實例1步驟A製備膠原漿物,依步驟B添加甘 油增塑劑至漿物中。在具有不沾粘(例如:PTFE)表面之平 盤上置入一層VICRYL篩網,然後將漿物倒在VICRYL篩網上 ,深約2毫米,藉以使VICRYL篩網浸入膠原漿物中。漿物 隨後於熱風中乾燥,產生VICRYL篩網包埋在膠原膜中形成 之複合層材質。這種複合層之詳細製法述於EP-a-094192 〇 然後採用規格爲20毫米X 40¾米之長方形複合層材質 F爲上述步驟D中之層壓層,製造所需之補缺器。 -14- 本紙浪尺度適用中國國家標準(CNS ) A4規格(2ι〇χ297公惫〉 ---------「裝—— (碕先閎讀背面之注意事項再填寫本頁〕 訂 J · 線 2^8565
發明説明(1: 貧例3 依下列方法製備一種修補韌帶或腱之生物可吸收性補缺 器’其中油微滴液勻散在生物可吸收性膜及生物可吸收性 海缔中: 依實例1步驟A製備膠原漿物。在此漿物中添加5〇%( 佔膠原含量之%,w/ff)芝麻籽油混合物在高切變下均質 化,使芝麻籽油乳化。膠原可作爲有效之乳化劑。 其餘製造步驟則依上述實例2之説明進行。 所製成之補缺器比實例2所製得之補缺器在活體内具有 顯著較緩慢之生物吸收性及較緩慢之抗張強度喪失性。 々上述明確具體實施例與實例僅供説明用。附錄申請專利 範圍内所定義之根據本發明許多其他具體實施例與方法係 相關技藝之專家讀者們咸了解者。 ---------裝丨| (請先聞讀背面之注意事項再填寫本頁) 訂 線 經濟部中央樣準局貞工消費合作社印製 15- 良紙張尺度適用中國國家榡率(CNS ) A4規格(210X297公釐)
Claims (1)
- ^11 Α8 Β8 C8 D8 六、申請專利範圍 „ 專利申請案第83109525號 ROC Patent Appln. No.83109525 , A修$$宏碕♦利滅困中文本一附件一 Amended Claims in Chinese - Enel. I (^興此平5月日~ϊ〇1 (Submitted on May , 1996) f 經濟部中央標準局員工消費合作社印製 1. 一種生物可吸收性韌帶或腱補缺器,其係呈包含下列螺 旋層之多層螺旋捲形式: a. —種合成之生物可吸收性材質之多孔層; b. 生物可吸收性膜;及 c. 生物可吸收性海綿層。 2·根據申請專利範圍第丨項之生物可吸收性補缺器,其中 多層螺旋捲之直徑爲12至21毫米。 3. 根據申請專利範圍第1或2項之生物可吸收性補缺器, 其中多孔層包含乳酸與/或m基乙酸之衆合物或共聚物 ,氧化再生之纖維素,聚二垮垸酮(polydioxaoneHPDS) ,乳酸與ε-己内驢胺之共聚物,聚羥基丁酸或羥基丁酸 與經基戊酸之共聚物。 4. 根據申請專利範圍第1項之生物可吸收性補缺器 ,其中多孔層係包埋在生物可吸收性膜中或海绵層中。 5. 根據申請專利範園第1項之生物可吸收性補缺器 ,其中多孔層之最大厚度在〇.〇2至0.3毫米之範圍内。 <5.根據申請專利範圍第1項之生物可吸收性補缺器 ,其中生物可吸收性膜包含一種生物聚合物或一種經化 學义鍵之生物聚合物衍生物。 7.根據申請專利範圍第6項之生物可吸收性補缺器,其中 生物聚合物包含膠原或聚葡糖胺。 S·根據申請專利範圍第1項之生物可吸收性補缺器 ,其中油微滴液係勻散在生物可吸收性膜中。 9.根據申請專利範園第8項之生物可吸收性補缺器,其中 -16- 本紙張尺度逋用中國國家標準(CNS〉Α4規格(210Χ297公釐) ---------{一衣------訂------f (請先閱讀背面之注意事項再填寫本頁) A8 B8 __ξ}__ 六、申請專利範圍 油之含量佔生物可吸收性膜重量1至9〇重量%。 讥根據申請專利範圍第1項之生物可吸收性補缺 器,其中生物可吸收性膜之厚度在0.01至0.1毫米之範 圍内。 让根據申請專利範圍第1項之生物可吸收性補缺 器,其中生物可吸收性海绵包含一種生物聚合物或一種 經化學交鏈之生物聚合物衍生物。 12.根據申請專利範圍第π項之生物可吸收性補缺器,其 中生物可吸收性海綿包含膠原或聚葡糖胺。 從根據申請專利範園第1項之生物可吸收性補缺 器,其尚包含生物可吸收性油之微滴液句散在生物可吸 收性海韩中。 14·根據申請專利範圍第13項之生物可吸收性補缺器其 中生物可吸收性油之含量佔生物可吸收性海轉重量1至 90重量%。 i反根據申請專利範園第1項之生物可吸收性補缺 器,其中生物可吸收性海綿層之厚度在0.5至2 5毫米之 範圍内。 經濟部中央揉準局員工消費合作社印製 (請先閲讀背面之注意事項再填寫本頁) 、-° 瓜根據申請專利範圍第1項之生物可吸收性補缺 器於製備供修補受傷之腱或勃帶之手術植入物上之用 途0 Π. —種製造供手術修補受傷之韌帶或腱使用之生物可吸 -17-經濟部中夾標準局員工消費合作社印製 Α8 Β8 C8 D8 六、申請專利範圍 收性補缺器之方法,該方法包括下列步驟: 由生物可吸收性材質之多孔層與生物可吸收性膜形成 層愚層;在層壓層上塗佈一層包含生物可吸收性聚合物 之水性凝膠;捲起層壓層,使凝膠層捲入螺旋捲中然 後乾燥凝膠,形成一層生物可吸收性海綿。 敗根據申請專利範固第1?項之製造生物可吸收性補缺器 之方法,其中該捲起步驟包括捲成2至6個完全36〇。 旋轉。 19_根據申請專利範圍第1?或is項之製造生物可吸收性補 缺器之方法,其中產生生物可吸收性膜之步驟包括下列 步驟: 由生物可吸收性材質之水性溶液或懸浮液形成一屛. 使該層乾燥。 2〇·根據申請專利範圍第I9項之製造生物可吸收性補缺器 之方法,其中該生物可吸收性材質之水性溶液或懸浮液 層係塗佈在合成之生物可吸收性材質之多孔屠上,或其 中合成之生物可吸收性材質層浸入生物可吸收性材質之 水性溶液或懸浮液層中。 21.根據申請專利範園第19項之製造生物可吸收性補 缺器之方法,其尚包括生物可吸收性油在該生物可吸收 性材質之水性溶液或懸浮液中乳化之步驟。 22根據申請專利範圍第17項之製造生物可 吸收性補缺器之方法,其中水性凝膠包含經酸膨脹之膠 原0 -18- 本紙張尺度適用中國國家標準(CNS ) Α4規格(210Χ297公釐) --------"{ 篆------、訂 ^ (請先閱讀背面之注意事項再填寫本頁) A8 B8 C8 D8 六、申請專利範圍 览根據申請專利範園第1 7項之製造生物可 吸收性補缺器之方法,其尚包括生物可吸收性油在水性 凝膠中乳化之步驟。 災根據申請專利範園第1 7項之製造生物可 吸收性補缺器之方法,其中凝膠乾燥形成生物可吸收性 海綿之步驟包括:冷凍凝膠,凝膠於減壓下蒸發水進行 冷凍乾燥。 25.根據申請專利範圍第1 7項之製造生物可 吸收性補缺器之方法,其中凝膠乾燥形成生物可吸收性 海綿之步驟包括:冷凍凝膠,然後使用溶劑乾燥凍結之 凝膠。 (請先閲讀背面之注意事項再填寫本頁) 笨. 、\\β 經濟部中央標準局員工消費合作社印製 -19- 本紙張尺度顧 t ®iH?7cNS ) A4«^ ( 210X297,^17
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- 1994-09-19 IN IN752CA1994 patent/IN182132B/en unknown
- 1994-09-27 CA CA002133028A patent/CA2133028A1/en not_active Abandoned
- 1994-09-28 ES ES94307076T patent/ES2134907T3/es not_active Expired - Lifetime
- 1994-09-28 JP JP6257351A patent/JP2963015B2/ja not_active Expired - Fee Related
- 1994-09-28 AT AT94307076T patent/ATE180977T1/de not_active IP Right Cessation
- 1994-09-28 MY MYPI94002577A patent/MY114130A/en unknown
- 1994-09-28 EP EP94307076A patent/EP0645149B1/en not_active Expired - Lifetime
- 1994-09-28 AU AU74306/94A patent/AU673769B2/en not_active Ceased
- 1994-09-29 KR KR1019940024682A patent/KR950007805A/ko not_active Application Discontinuation
- 1994-09-29 US US08/314,986 patent/US5514181A/en not_active Expired - Lifetime
- 1994-10-14 TW TW083109525A patent/TW298565B/zh active
-
1995
- 1995-06-07 US US08/485,244 patent/US5595621A/en not_active Expired - Lifetime
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1998
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TWI666006B (zh) * | 2016-10-06 | 2019-07-21 | 美商琳得科美國股份有限公司 | 用於人工肌肉及致動器之塗層 |
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AU7430694A (en) | 1995-04-13 |
HK1002251A1 (en) | 1998-08-07 |
KR950007805A (ko) | 1995-04-15 |
GB2282328B (en) | 1997-10-08 |
MY114130A (en) | 2002-08-30 |
CA2133028A1 (en) | 1995-03-30 |
ES2134907T3 (es) | 1999-10-16 |
GB9320100D0 (en) | 1993-11-17 |
EP0645149A1 (en) | 1995-03-29 |
EP0645149B1 (en) | 1999-06-09 |
JPH07250889A (ja) | 1995-10-03 |
GB2282328A (en) | 1995-04-05 |
US5514181A (en) | 1996-05-07 |
AU673769B2 (en) | 1996-11-21 |
ZA947263B (en) | 1996-03-19 |
ATE180977T1 (de) | 1999-06-15 |
IN182132B (zh) | 1999-01-09 |
US5595621A (en) | 1997-01-21 |
JP2963015B2 (ja) | 1999-10-12 |
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