TW592660B - Implant intervertebral amortissant - Google Patents

Implant intervertebral amortissant Download PDF

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TW592660B
TW592660B TW090117090A TW90117090A TW592660B TW 592660 B TW592660 B TW 592660B TW 090117090 A TW090117090 A TW 090117090A TW 90117090 A TW90117090 A TW 90117090A TW 592660 B TW592660 B TW 592660B
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spinous process
patent application
implant
wings
intervertebral implant
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TW090117090A
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Couedic Regis Le
Jacques Senegas
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Spine Next Sa
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7053Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842Flexible wires, bands or straps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Vibration Dampers (AREA)

Description

592660 A7 ___ B7- 五、發明説明(1 ) 本發明係關於一種特別設計放置於兩個脊椎骨棘狀突之 間之椎間植入物。 本類型之植入物係嵌入並固定於通常源自椎間盤毁損之 棘狀突之間°特言之,當一個椎間盤之後部毀損時,脊椎 的伸展會使兩個脊椎骨由該盤分離並不正常地互相靠攏。 而此通常會使神經根被陷住並使受到這種問題困擾之病人 感覺到疼痛。 椎間植入物包含一個間隔物嵌入棘狀突之間以及彼等包 含固疋裝置者係已知。該等間隔物通常由鈦合金構成,在 其兩端各有一 V-型缺口,而棘狀突在與該v-型缺口砌合。 此外’该間隔物係以繫結固定,將兩個v-型缺口之相反兩 緣交互連接並繫緊在各棘狀突之部分壁上。 孩植入物可以限制脊椎骨之延伸向彼此靠攏,因為當脊 椎延伸時’該棘狀突會靠向接合點抵住嵌入植入物兩側V — 型缺口之底部。然而該等植入物之間隔物所使用之材料比 2間盤(當它為完整時會限制脊椎骨向彼此延伸靠攏)的材 貝硬太多,因此瞬間搖動(例如走動時)會傳遞至脊椎而無 法被制動於兩個脊椎骨之間交互連接之間隔物上。甚者, 因為間隔物之機械性質與殘存部分之椎間盤機械性質不 同’使整體脊椎之機械性質相較於完整的脊椎呈現明顯的 不連貫,也因此加速椎間盤的毀損。 本發明之目的係提供一種椎間植入物其中具有兩相反的 V-型缺口與棘狀突接合抵住,該¥_型缺口具有相對可動性 使該二V-型缺口之間的相對運動可以被減緩。 -4-
592660 A7
兩個脊椎骨 該間隔物含 為達成本目的,本發明提供一種設計放置於 棘狀突之間之椎間植入物,該植入物之特徵 有: …、 两1U由第一種材料所構成之元件,而各個元 端及第二端,該第一端可固定於一個棘狀突;及 又 由第二種較第一種材料更具彈性變形性之材料 ^ 連接段,該連接段交互連接該兩個元件之 ^ ^ 一 碼,如 J: 作用在該兩個元件(10,12)的壓力會因此減輕,而且該土 接段可以將該椎間植入物限制並止住該脊椎骨之相^養 作0 - 藉由將連接段放置於兩個元件之間,各個元件各自固— 一個棘狀突,當棘狀突向彼此靠攏而壓縮時,連接段會2 收施加在該元件上的壓力。其結果為當脊椎骨向彼二靠2· 時仍帶有特定量之彈性,這與完整推間盤所賦予之天然^ 性相近。甚者,該脊椎骨之相對彈性動作與維繫脊椎骨在 一起之後韌帶之彈性變形相容。由此所獲得之系銑,2壓 力下,其元件之相對動作與原始完整系統元件之相對動5 實質上相同,因此可保護各元件免於進一步毀損。 在優勢上,該間隔物主第二端代表一種固定壁,在上面 該連接段可適合與其鍵結。因此,並不需要再使用額外的 固定元件而且該第二種材料之黏著特性可與該固定壁互相 搭配。 在本發明之特定具體實施例令,該固定壁帶有凹陷因而 適合與該連接段之突起互相搭配而使得該連接段與固定辟 -5- 本纸張尺度適用中國國家標準(CNS) A4規格(210X 297公釐)
A7
之結合更加緊密。吾人當明瞭因為凹陷係形成於壁上,所 亥壁之表面積因此增加,當一種材料可以模塑而與另一 種材料之壁配合時其接觸面積也會因此增加。增加接觸面 積^增加該連接段與該二元件之間的連接力。甚者,該等 凹陷的形成方式是除可增加接觸面積之外,同時還增加該 二元件與連接段材料之間的靜磨擦力,該磨擦力進一步增 加連接力道。 較佳者,該連接段之第二種材料係由一種經由聚合所產 ^的物體構成。其結果為,如果該材料在事先聚合產生則 4連接段可以輕易地經由熱模塑成該元件,或是如果該構 成第二種材料之單體聚合的速度慢到時間足以完成組合, 則該材料可以在現場再行產生。 在本發明之較佳具體實施例中,該元件之第一種材料係 鈦合金。因此可以輕易地在該固定壁上形成凹陷而使該連 接段適合與其結合。 在第一個特定具體實施例中,該二元件之第一端各自在 兩翼間形成一個V-型缺口使其適合接受一種棘狀突,而該 植入物進一步包含一個可調整長度連接該二翼之結,該結 纏繞於該m之-部&而使㈣_端得以固$於該棘狀 突。 此椎間植入物之特徵使得該元件得以固定至棘狀突。在 每一個間隔物該元件之上已經事先安置一個結,一但將該 間隔物嵌入兩個突起之間’經由將結繫緊即可將該元件固 定於突起。 -6 本紙張尺度適用中國國家標準(CNS) A4規格(210X297公爱) 592660 A7 ____ B7 五、發明説明(4 ) 在本發明之第二個具體實施例中,該二元件之第一端各 自在兩翼間形成一個V—型缺口使其適合接受—種棘狀突, 而違植入物進一步包含一個栓子可以適合由側面穿過該翼 及該突起進而將該第一端固定於該棘狀突。 在如此構造下,該棘狀突係經由橫向戳孔,而該等元件 則藉由栓子或是鉚釘穿過件的兩翼及穿過置於其間的突 起。該栓子或鉚釘固定於一個或兩個翼的方式係可免於意 外地脫離。 在本發明之第三個具體實施例中,該二元件之第一端各 自在兩翼間形成一個V-型缺口使其適合接受—種棘狀突, 而該植入物進一步包含一個形成夾子之半圓形組件連接該 翼’該夾子纏繞該棘狀突之一部分進而將該第一端固定於 該棘狀突。 其結果是,當間隔物嵌入後,該夾子可輕易的固定於該 元件之翼上。經由下文更進一步的解說,在本特定之具體 實施例中,因為翼已分離,可以不需在後韌帶進行大手術 即可將間隔物嵌入。 本發明其他特性及優點將可由閱讀下列以參照附圖之非 限制性說明本發明特定具體實施例之敘述而顯現,其中: 圖1係本發明椎間間隔物之軸切面觀; 圖2係一種圖繪之立視觀顯示其帶有可調整固定結之椎間 植入物; 圖3係一種圖繪之立視觀顯示其帶有固定栓之推間植入 物;及
592660 A7 B7-
物,而是只要具有類似性質之任何其他材料均可。 該連接段14之材料適合鍵結至該兩個實質上 個端1〇b,12b之固定壁。然而,為了增加黏著力,在⑽及 12b端之固定壁上形成凹陷16,而該凹陷則可與連接段μ之 突起18搭配使其嵌入其中。 該等特性可以,首先增加兩種材料之接觸面積,藉以該 接觸面上增加正向之連接力’再者亦可產生靜磨擦力進一 步增加鍵結力道。 該種連接的形成係將在一個模子内將熱聚合物注射到面 對面安置的兩個元件10及12之間,或是使冷的單體混合物 在兩個元件丨0及12之間模塑成形,如果該單體混合物之反 應速度夠慢。當液體或半液體之聚合物嵌入凹陷後,等到 冷卻或化學反應之後,該突起18即可當場形成。吾人當明 瞭該連接段14係由置於元件10及12之間的聚合物所構成, 為了使其在液體狀態時仍可待在兩個互相面對之元件之 間,該模具必須有必要地與元件一致的包覆元件間的空 間。 二 在一個特定的具體實施例中(在此未顯示),在固定壁所 形成之凹陷16向外開口至元件10及12的外壁,如此可使液 體之聚合物完全滲入凹陷12而不會有任何氣體被包埋其 間。其結果為使得連接段14與元件材料間之連接力到增 強。 曰 此外,雖然該凹陷在圖丨中顯示係與間隔物之縱軸平行, 但是可以允許其形成時與縱軸相對歪斜及/或為非直線形。
裝 訂
-9 **
592660 A7 B7 五、發明説明(8 ) 該套結30及32分別繞過上面棘狀突34之頂部及下面棘狀 突36之底部使得該棘狀突34及36可以分別鎖定於v_型缺口 10’a及12,a上。鎖定之動作係將套結3〇及32在翼21及23處所 形成之狹孔塞陷到翼2 1及23拉緊即可。 因此,元件10及12分別固定於相對應之突起34及36,而 該突起34,36之相對運動則因此可能在該由聚合物形式材 料所作成之連接段14之變形極限内進行。 當兩個棘狀突3 4及3 6向彼此靠攏時,特別是脊椎骨延展 時’該二元件10及12係以彈性方式壓迫連接段14,即欲將 兩個棘狀突34及36維繫使其不互相分離的反應力,實質上 與兩個突起之移動成正比。因此,該植入物可取代要被置 換椎間盤(或是要被置換椎間盤一部分)的角色,該椎間盤 的角色是維持在該二脊椎骨之空·間避免陷住任何神經根。 同時亦可能產生使施加在棘狀突的壓力與背部勃帶作用在 突起的壓力相容的結果。 甚者’當兩個棘狀突34及36向彼此移開,脊椎骨彎曲 時’該連接段會受到牵引而有回應力,其實質上與其受到 延伸的力道成正比,至少在小幅度時是如此。因此脊^骨 的彎曲幅度可以比將兩個棘狀突以固定方式將彼此固定所 得的彎曲幅度來得大。 圖3顯示本發明之第二個特定具體實施例,其中該^型缺 口之翼及嵌入其間之棘狀突係以一個穿過棘狀突之栓子鎖 定。 圖3顯示介於兩個棘狀突34及36之間的椎間間隔物,以及 -11 -
592660
成對的翼20,21及22,23納入突起34及36的部分^甚者, 分別有隻栓子40穿越V-型缺口 l〇’a及12,a,以及棘狀突34及 36。該翼20,21及22,23則分別戳入兩個相對面的小洞, 讓拴子40由此嵌入並在其端的位置固定。 在將植入物嵌入棘狀突34及36間之前,該棘狀突必須先 由側面戳入小洞而其直徑必須大於栓子40的直徑。然後將 该椎問間隔物嵌入棘狀突34及36—之間,接著將該形成鉚釘 之栓子40送進穿越翼20,21及22,23以及其相關之棘狀突 34及36。該栓子40的兩端再由縱向向内打平使其兩端的直 徑大於其所穿越翼20,21及22,23的小洞直徑。以此方 式’該栓子40可以相對於間隔物縱向的方式鎖住,而且該 二元件10及12可以因此固定於棘狀突34及36。 在本發明的第二個具體實施例中,不需要除去棘間韌帶 或是切開棘上韌帶,該等韌帶係襯墊並覆蓋間隔物要嵌入 之椎間空間。在嵌入間隔物期間,因為成對之翼2〇,2 1及 22 ’ 23並未以適當方式纏繞棘狀突而交互連接,因此有必 要先除去棘間韌帶而且僅從要嵌入間隔物的椎間空間處將 棘上韌帶切開。 圖4顯示本發明之第三個具體實施例,其所具有的優點與 前述第二個具體實施例相同。 圖4顯示介於兩個棘狀突34及36之間的椎間間隔物,以及 成對的翼20,21及22,23納入突起34及36的部分。不同的 是該椎間間隔物之元件1〇及12係分別由形成夾子之半環狀 組件42固定於棘狀突34及36。 -12- 本紙張尺度適用中國國家標準(CNS) A4規格(210X 297公釐)
裝 訂

Claims (1)

  1. 592660 第090117〇9〇號專利申請案 -中文申凊專利範圍替換本(93年4月) 、申清專利範圍 1.種植入物’其包含一種放置在兩個脊椎骨棘狀突 =,36)之間之間隔物,該植入物之特徵為該間隔物包 ::由第-種材料所構成之元件(1。,12),而各個元 牛,、有第-端⑽,12a)及第二端⑽,叫,古亥第一 端(l〇a,12a)可固定於一個棘狀突(34 , 36);及 及由第_種較第_種材料更具彈性變形性之材料所構 成=接段(14),該連接段交互連接該兩個元件(1〇,⑺ 之該第二端(⑽,12b) ’如此作用在該兩個it件(10, 12) 的壓士會因此減輕,而且該連接段可以將該椎間植入物 限制並制止該脊椎骨之相對動作。 2. 根據申請專利範圍第旧之椎間植入物,其特徵為該第 一端(10b,12b)具有一個固定壁可以適合與該連接段(14) 結合。 3. 根據申請專利範圍第2項之椎間植入物,其特徵為該固 定壁具有凹陷(16)可以適合與該連接段(14)之突起(18) 搭配而增加該連接段(14)與該壁之間的結合力。 4. 根據中請專利範圍第⑴項中任何_項之椎間植入物, 其特徵為該連接段(14)之第二種材料係一種經由聚合而 得之物體所構成。 5·根據申請專利範圍第π項中任何一項之椎間植入物, 其特徵為該元件(10,12)之第一種材料係鈦合金。 6.根據申請專利範圍第丨至3項中任何一項之椎間植入物, 其特徵為該二元件(10, 12)之第—端(1〇&,12a)各自在 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公釐) •裝 玎 m 592660 、申請專利範圍 A8 B8 C8 D8 9
    兩翼(20 ’ 21,22,23)間形成一個 V-型缺口( 1(),a,12, a) 一適5接雙一種棘狀突(34,36),而該植入物進一步 包含一個可調整長度連接該二翼(20,21,22,23)之結 (3〇 ’ 32) ’該結(3〇,32)纏繞於該棘狀突(34,36)之一 部分而使該第一端(l〇a,12a)得以固定於該棘狀突(34, 36) 〇 7·根據申請專利範圍第1至3項中任何一項之椎間植入物, 其特徵為該二元件(10,12)之第一端(l〇a,12a)各自在 兩翼(20’ 21 ’ 22’ 23)間形成一個 V-型缺口(1〇,a,12, a) 使其適合接受一種棘狀突(34,36),而該植入物進一步 包含一個栓子(40)可以適合由側面穿過該翼(2〇 , , 22’ 23)及該突起(34,3 6)進而將該第一端(i〇a,i2a)固 定於該棘狀突(34,36)。 8·根據申請專利範圍第1至3項中任何一項之椎間植入物, 其特徵為該第一端(l〇a,12 a)各自在兩翼(2〇,21,22, 23)間形成一個V-型缺口( 10’a,12, a)使其適合接受一種 棘狀突(34,36),而該植入物進一步包含一個形成夾子 之半圓形組件(42)連接該翼(20,21,22,23),該夾子 (42)纏繞該棘狀突之(34,36) —部分進而將該第一端 (10a,12a)固定於該棘狀突(34,3 6)。 -2- 本紙張尺度適用中國國家標準(CNS) Α4規格(210X297公釐)
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EP1299042B1 (fr) 2006-03-22
FR2811540A1 (fr) 2002-01-18
AU2001277583B2 (en) 2005-12-08
US20040106995A1 (en) 2004-06-03
PE20020111A1 (es) 2002-03-02
US7238204B2 (en) 2007-07-03
US7666228B2 (en) 2010-02-23
KR20030018016A (ko) 2003-03-04
DE60118203D1 (de) 2006-05-11
DE60118203T2 (de) 2007-04-12
JP4330336B2 (ja) 2009-09-16
ATE320761T1 (de) 2006-04-15
US8349016B2 (en) 2013-01-08
WO2002003882A2 (fr) 2002-01-17
EP1299042A2 (fr) 2003-04-09
JP2004502490A (ja) 2004-01-29
ZA200300158B (en) 2004-02-05
FR2811540B1 (fr) 2003-04-25
WO2002003882A3 (fr) 2002-05-23
KR100800886B1 (ko) 2008-02-04
US20100100187A1 (en) 2010-04-22
ES2260254T3 (es) 2006-11-01
US20070213829A1 (en) 2007-09-13
AU7758301A (en) 2002-01-21

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