TW396035B - Strain regulating fusion cage for spinal fusion surgery - Google Patents

Strain regulating fusion cage for spinal fusion surgery Download PDF

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Publication number
TW396035B
TW396035B TW088115014A TW88115014A TW396035B TW 396035 B TW396035 B TW 396035B TW 088115014 A TW088115014 A TW 088115014A TW 88115014 A TW88115014 A TW 88115014A TW 396035 B TW396035 B TW 396035B
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TW
Taiwan
Prior art keywords
scope
grooves
patent application
item
stent
Prior art date
Application number
TW088115014A
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English (en)
Inventor
Stephen J Bresina
Konrad Tagwerker
Manuel Schar
Original Assignee
Synthes A G Chur
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Publication of TW396035B publication Critical patent/TW396035B/zh

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
  • Percussion Or Vibration Massage (AREA)

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A7 B7 五、發明說明（/ ) 本發明係關於一種依據申請專利範圍第1項所界定之 椎間融合支架。 支架類植入物乃用於脊柱融合術。該支架可提供支承 直至移植物材料骨化而使兩相鄰之脊椎體終板融合在一起 。骨化出現並且融合完成愈快對病人愈好。 由前技可知數種椎間植入物。WEBB之W0 098/09586 號案揭示一種中空之圓柱形椎間植入物，其基本由一種呈 現最大3 0 %體積百分比之多孔性的陶瓷材料製成，而且 其中之孔係被充塡以空氣。此已知之椎間植入物乃設計來 承受作用於脊柱上之不同負荷，並於其終板處提供一種充 分大之支承，以防此些終板沈入相鄰之脊椎體中。 另一種椎間植入物可見COTTLE之WO 97/15248號案 。其由一種圍合一定空間之框架狀支架所組成。此習知之 支架大致爲楔形，頂面及底面朝前壁分出，從而提供一種 優點，即由於頂面及底面有大的骨骼承托區，使該植入物 得以免於沈入脊椎體之終板內。 所有此些習知既有之支架，縱然具有錯綜複雜之切槽 圖案，該等支架均相當之剛硬並且保護該移植物不受到應 力以及應變。 再一種椎間植入物可見KN0THE之W0 97/15247號案 。其由一平坦形之中空兀件所組成。其上方及下方骨路接 觸面可朝該元件之內室彈性地壓縮，而使得該等上方及下 方骨骼接觸面間之最大距離可減少0 . 5 — 5 . 〇mm。 使用此些前技之中空支架，導入支架內之移植物可承 _ 4 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） (請先闉讀背面之注意事項再填寫本頁) - . 术·!11 訂！ II I 線. 經濟部智慧財產局員工消費合作社印製 經濟部智慧財產局員工消費合作社印制衣 A7 B7 五、發明說明 受與負荷成比例之應變。 又一種椎間植入物可見RATRON之EP-A0716814號案 。該揭示之修復物提供一種可彈性變形之主體，該主體係 具有某一彈性率k ·，直至該修復物內一上孔於一定之負荷 .下閉合爲止。一俟此上孔閉合，即達及另一彈性率k2，此 •彈性率不同於彈性率1^，遂致使相鄰之脊椎體可承受一種 '較大之負荷。此習知之椎間植入物於正交之方向並不開設 ——個或多個凹孔，其中該移植物可被導入並將兩枏鄰之脊 椎體終板骨化融合在一起。該等不同之彈性率可讓該修復 '物在達及運動之撓曲/伸長範圍端點時能夠在剛度上增大 〇 今已發現，骨質重建受峰値應變之控制，而且每曰只 要有幾次高於一定程度（1 Ο Ο Ο # ε )應變變化-，-便足 以維持骨質。應變高於1 Ο Ο Ο /ζ ε並高達5 %或5 0， Ο Ο Ο μ ε係可成比例地增加新骨質之形成。若有一融合 支架可讓移植物得以達及此些應變程度，則移植物即能礦 化得更快。 因此，應變便界定成e = (5L/L，其中5L爲物體 於負荷所加諸的軸線方向上之變形，而L爲未加載之物體 於負荷將被加諸的軸線方向上之高度或長度。 標準之支架設計（包括最後所述者）所具有額外的問 題係加諸於移植物之應變將因不同之病人而異。小病人裝 入之支架將小於大病人。若一病人正經受著病痛，則其所 裝之支架將遠小於感覺良好之人所裝入者。 _ 5 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） ------------' :衣--------訂---------線 (請先閱讀背面之注意事項再填寫本頁) A7 B7 五、發明說明（5) 而且只有高於一定之負荷程度才能達及最佳之應變程 度。故加諸於移植物之應變可能不再適於促進骨質之形成 。該等習知之支架質地剛硬，而且爲產生大於1000// ε之應變所需之負荷可能甚高。 :在此，本發明提出一種對策。本發明基於之任務係爲 允許理想之應變能夠於小負荷下在受圍的.材料中達 成，同時保護移植物，使之免受可能導致幾械性敗 .壞之高應變。該椎間支架係被設計成在軸向_^荷下可極 具撓性。一俟達及所薷之應變程度，該支架上方與下方部 ....... · 份間之接觸即可顯著增大裝置之剛度,。.較高之負荷將只增 加非常小之附加應變。此舉可不管所加諸之生理負荷，而 允許讓相當一致之應變得以加諸於移植物材料。 在依據本發明的椎間支架之一種較佳實施例中，支架 乃設計成得以讓其於垂直方向非常柔順，直至達及一定之 位移始止。此位移量可設計於該植入物內，以讓允許移植 物能夠曝露在所需之應變程度，即1000至50, 00 0 # ε，最好是 3000至10, 000 从ε。 一俟達及此位移量，支架之上方與下方部份即會接觸 ，從而支架變得非常剛硬，使之對於所增加之負荷僅允許 有數値非常小之額加應變。此舉可不管所加諸之負荷，ft 如200 N或1000 N，而允許相同之應變得以出 現於移植物上。 依據此較佳實施例之應變調整融合支架包含有一稜柱 形支架，且該稜柱形支架係具有：一上方與一下方揆觸面 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） (請先閱讀背面之注意事項再填寫本頁)
*SJ -線- 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明（次） (請先閱讀背面之注意事項再填寫本頁) ’兩面橫垂於其縱向軸；一中央空腔，其延伸於該上方與 下方接觸面之間，用於收納骨質移植物材料；以及複數個 貧穿周壁並橫垂於縱向軸線之槽。該等槽係錯開地排列， ‘而使得於兩不同高度之各一處，各設有總數爲四槽中之兩 .槽，因此該等槽於各高度處覆蓋周壁之相對扇區，而且於 該雨不同高度處排列成使得所有扇區之角度總和爲大於3 6 0。，並且位於該兩不同高度處之槽係彼此部份地童疊 再者’該等槽具有最小之寬度，一旦循中心軸壓縮支架 体至所需之應變程度，該等槽即於彼等最小寬度處彈性地 . . . . ... 閉合，而顯著增大支架之剛度。此最小寬度可取決於該植 入物之高度以及所需之應變程度而定。. 於依據本發明之應變調整融合支架之另一較佳實施例 中’支架之高度沿縱向軸線方向爲6 mm，而槽在未加載狀 態時於縱向軸線方向所測之寬度爲〇 . 〇 1 8mm。當具有 此些尺寸之應變調整融合支架之槽於所需之負載下閉合時 ’所產生之應變程度爲300〇#ε。 於依據本發明之應變調整融合支架之又一實施例中， 支架之高度沿縱向軸線方向爲1 5 imn，而槽在未加載狀態 時之寬度爲0 · 1 5mm，當槽在所加諸之負載下閉合時， 所產生之應變程度爲1 〇，〇 〇 〇 # ε。 本發明以及本發明進一步之實施例在下文中藉由局部 示意圖加以更詳細地討論。 該等附圖顯示·· 第一圖係依據本發明一實施例之藤變亂整融合支架」 本紙張尺度適用中國國家標準（CNS)A4規袼（210 X 297公餐） A7 B7 五、發明說明（f) 應用於腰部時，植入一段脊柱內之側視圖； 第二圖係依據本發明之一應變調整融合支-架之示意圖 '第三圖係第二圖所示依據本發明之變調整融合支架 其示意圖之一剖面； ./第四H.係第二圖所示依據本發明..之攥變調整融.合支.架 其示意圖之另一剖面； 第五圖係依據本發明一實施倒之應簑調整融合支擊之 立體圖； ： . 第六圖係第五圖街示依據本發明該賓施例之應變調;擊 M-合玄絮之另二,.立體圖j: 第七圖係第五圖所示依據本發明該實施例之應變調.整_ » 融合支架之側視圖； , 第八圖係第五圖所示依據本發明該實施例之應屬調整 融合i架之側視圖，圖冲位於下方之槽於彼等最小寬度處 閉合； 等:也麗_係隹擰本發明第五圖所示該賓施例之應變調整 融合支架之側視圖，圖中_上方與下方諸糟均於彼等最小寬 度處閉合i
.第十圖係一圖表，反味可變彈性率與加諸於第五圖所 示依據本發明麗實槪凰之」應變調整融合支架之應變有關L ..以及. 第^^一圖係脊柱·中有一依據本發驵某一實施例之應變 :調莩融合支架植入稚間座聞..內之側視圖。_ _'_ 8 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） (請先閱讀背面之注意事項再填寫本頁) ^.——1 訂-!-線. 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明（t) 第一圖顯示依據本發明一實施例之應變調整融合支架 應用於腰部兩脊椎體1 2、1 3間一椎間空間1 4內之 情形。 於第二圖中乃顯示一依據本發明之應變調整融合支架 之7^意圖。該支架1包含有一具中心線2之中空之圓柱體 、—上方接觸面3、一下方接觸面4 '以及一延伸於該等 上方與下方接觸面3、4間之同軸空腔5。於高度爲111處 ’有兩扇形槽8、9貫穿周壁1 〇成對稱於一第一直徑， 並循形成兩扇區1 7、1 8之直徑相反方向，誠如第四圖 中所示。另兩扇形槽6、7 (圖中槽7並未顯示）於高度 爲1^2處貫穿周壁1〇，其中此高度爲好1係較高度丑2爲 接近於上方接觸面3。此些設置於上方高度Η 2處之槽8、 9亦貫穿周壁1 〇而對稱於一第二直徑，並循形成扇區1 5、1 6之直徑相反方向，誠如第三圖中所示。該等位於 上方高度Η2處且設置成對稱於第二直徑之槽6、7係相對 於位於下方高度1^處（第四圖）且設置成對稱於第一直徑 之槽8、9而被錯開排列，因此第一直徑係正交於第二直 徑。再者’於上方高度Η 2處覆蓋扇區1 5、1 6之槽6 ' 7係部份地疊蓋於下方高度Η 1處覆蓋扇區1 7、1 8之槽 8、9。此種在周壁1 0上餘留於槽6、7、8、9間之 支柱19、20、21、22係可藉由支架1被壓縮之機 構而予彈性地壓縮。 第五及第六圖顯示依據本發明之應變調整融合支架1 之較佳實施例。該支架1具有一稜柱形外形而帶有一上方 _____________-__9 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） ——：--------^ ^ — (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印製 經濟部智慧財產局員工消費合作社印製 A7 B7 五、發明說明（1) 接觸面3、一下方接觸面4、一縱向軸線2、以及一同軸 於該縱向軸線2且延伸於上方與下方接觸面3、4間之橢 圓孔5。橫垂於縱向軸線2之橫剖面係顯示支架1之外周 線，其係爲具有一種不規則多邊形之形狀。下方接觸面4 .爲平坦者，且延伸成橫垂於縱向軸線2。橫垂於支架1之 前側面2 3的上方接觸面3爲凸形之造型，且於前側面2 3與後側面2 4處朝向下方接觸面3聚合。平行於支架1 .之前侧面2 3，該上方接觸面3並非彎曲而使得支架1成 爲一種楔形。槽6、7、8、9於橫垂於縱向軸線2之兩 個平面上貫穿支架1之周壁1 0，因此該等平面可位於下 方接觸面4上方兩不同之高度H ：l、Ή 2處。各平面含有兩 槽6、7、8、9，兩者於周壁1 0內循直徑方向相反地 配置。於高度爲Hi較接近於下方接觸面4的之平面內（第 七圖）的槽6、7係平行於支架1之前側面2 3而伸展開 ，而於高度爲Η 2較接近於上方接觸面3之平面內（第七圖 )之另兩槽8、9則係正交於支架1之前側面2 3而伸展 ，致使該等槽6、7、8、9於兩不同高度Hi、Η2係錯 開開設，而且每一槽6、7、8、9覆蓋周壁10之另一 扇區。再者，較接近下方接觸面4的平面內之槽6、7係 形成僅部份平行，因此此些平行之部份可提供槽6、7之 最小寬度h1、h 2 (第七圖）。於非平行之部份，槽6、 7則提供一種彎曲形。位於較高高度Η 2平面內之槽8、9 爲彎曲形，因此該等彎曲形可於該等槽7、8之最小寬度 h3、h 4內形成一種小且幾乎平直狀之區域。 10 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） --------------( ^-- (請先闉讀背面之注意事項再填寫本頁) -^-°
A7 B7 五、發明說明（沪） 第八圖反映第五、六及七圖中所示之應變調整融合支 架1 ,，.其中支架1被嚴重壓縮，而使得位於較接近於下方 接觸面4的平面內之槽6、7係於彼等具最小寬度hl、h 2之部份處閉合。 於第九圖中，第五、六、七與八圖中所示之應變調整 融合支架1係受載，而使得該支架1被壓縮成致使位於較 接近於下方接觸面4的平面內之槽6、7，以及位於較接 …近於上方接觸面3的平面內之槽8、9，能夠於彼等具最 小寬度h i、h 2、h 3、h 4之部份處閉合。 第十圖例示支架1之彈性率，圖中該支架1隨著壓縮 而同軸地提供一種彈性率c 1，直到第一組槽6、7於彼等 之最小寬度h i、h 2處閉合爲止，並且隨著進一步之壓縮 而能夠提供一種介於1與5倍於c :之彈性率c 2，直到第 二組槽8、9於彼等之最小寬度h3、h4處閉合爲止，而 致使支架1之剛度得以一種未知的彈性率梯度而更進一步 增加。 第十一圖顯示依據本發明一實施例之應變調整支架1 植入兩脊椎體1 2、1 3間一椎間空間1 4內情形。 (請先閱讀背面之注意事項再填寫本頁) 訂---------線. 經濟部智慧財產局員工消費合作社印製 —. — 11 表紙中國國家"ii (CNS)A4 規格（210 X 297 公釐）

Claims (1)

  1. A8 A8 經濟部智慧財產局員工消費合作社印製 C8 D8 六、申請寻利範圍 1 _ 一種包含有一稜柱形、錐形或圓形支架（1 )之 椎間融合支架，其具有 A)—中心軸（2); B ) —上方與一下方接觸面（3、4 )，兩面橫垂於 該中心軸（2 )，其中該等上方及下方接觸面（3、4 ) 被指定在將該支架體（1)植入椎間空間（14)內時， 用以接觸兩相鄰之脊椎體（1 2、1 3 ); C ) 一中央$麗15_3_，基係甩於收納骨質-移篠物材 料，且延伸於該下方接觸面....(..I)…與該士者接觸面.(3…) 之間，.並穿經該支架體（1 )..而界定出一設置成同軸於該 , ...V ...... +心軸（2 )之周壁（1 0);以及 D )複篆個扇形檀J 6、7二8 9)，其係蒽穿周壁 (1 0)並橫垂於中心軸（2 ); .特徵在於： f)該等槽（6、7、8、9)具有最小之寬度(11 1 ' h 2 ' h 3 ' h 4 )，一旦循中心軸（2 )壓縮支架体（ 1 )，則該等槽（6、7、8、9 )即於最小寬度（h i、 h 2、h 3、h 4 )處彈性地閉合，藉此於更進一步壓縮時 能夠增大支架（1 )之剛度。 2 .如申請專利範圍第...1屋所述之推..闓.崴合.支垄’特 徵在於:隨著猸車4、軸(2 J-勝縮-支榮體^ 0 0 0艮&與5-0，、0. 0__.01.遗某.二應-變程虞 槽（6 二Z」8、— 9 )—即最 h 4 )處彈性，地閉合.藉此在進一步壓縮睦能姐增大支架._( _____ 1 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公楚） -------- I I --- I__I ! y . \/05 广) (請先閱讀背面之注意事項再璩寫本頁) tr'i----ΪΛ #:丨 A8 B8 C8 D8 六、申請寻利範圍 1)之剛度。 3 ·如申請專利_範—圍—第—2.項斯述之狼間融合支架，特 徵在於：.隨著循中心軸（2 ).壓縮支架體(丄J:至介於3 〇 〇 〇 # ε與1 〇 ’ 〇— 〇〇.――間1二應屢程-度睦」該等 槽（6、7、8、9 )—即-於-最小寬度—_.. C 上-1-一、h 2、h 3、 h4·)處彈性地閉合，藉此在進一步壓縮時能夠增大支架（ 1)之剛度。 ' 4.. ·如宇請專利範圍第1至3_蓮电任一項所·之椎間 、、.融合支架’特徵在於：隨著壓縮，支架（1 )即同軸地提 供—種彈性率c 1，直至槽（6、7、8、9 )於彼等之最 寬度（h i、h 2、h 3、. h 4 )處閉合爲止，而隨著進一 .步地壓縮’則提供一種介於Γ 〇與1 0〇倍於c i之彈性率 _ h 2-°…… 5 ·如申請專利範圍第1項所述之椎間融含支架，特 徵在於：隨著壓縮.，支架（1.1即同軸地提..供一種彈性率 c !，直至槽（6、7、8、9 ). ..Φ第一組於彼等之最小寬 度（h i、h 2、h 3、： h 4 )處閉合爲止，面麗蓍更進一步 地壓縮’則提供一種介於l1 . 〇奥5倍於.CL i之j單性率c 2 ’直至槽（6、7、8、9 )中第二組於彼.等之最小寬度 (h i、h 2、h 3、h 4 )處閉合爲止，而導致支架（1 ) 之剛度進一步增大。 _ 1 6 ·如申請專利範圍第1項所述之椎衢融合支架，特 徵在於··該等槽（6、7、8、9 )於下方接觸面（4 ) .. - .. 上方至少兩個不同高度（H i、H 2 )處貫穿周壁（1〇 ) _ 2 本紙張尺度適用中國國豕標準（CNS)A4規格（210 χ 297公釐） (請先閱讀背面之注意事項再歡寫本頁) 訂· --線； 經濟部智慧財產局員工消費合作社印製 A8 B8 C8 D8 經濟部智慧財產局員工消費合作社印製 六、申請專利範圍 7 ·如申請專利範圍第1項所述之椎間融合支架，特 徵在於：該等槽（6、7、8、9)於至少兩個不同高度 (Η:、H2 )處錯開地開設。· 8 ·如申請專利範圍第1項所述之椎間融合支架，特 徵在於：該等槽（6、7、8、9 )於兩個不同高度（ 、Η2 )處錯開地開設。 9 ·如申請專利範圍第1項所.述之椎間融合支架，特 徵在於：各槽（6、7、8、9 )覆蓋該周壁（1 0 )之 >·. ... 另一扇區（1 5、1 6、„1.7、1 8 )，而填得所有扇區 之角度總和爲至少3 6 0 ° 。 1 0 ·如申請專利範圍第9項@述之椎間融合支架， j寺徵在於：該等扇區（1 5、16、1 7、1 8)彼此部 份地重疊。 11·如申請專利範圍第1項所述之椎間融合支架， ，特徵在於:該等槽(6.、7、8、9 )提供一種寬崖（hi ' h 2 ' h 3 > h 4 )，而使得一俟支架體（1 )循中心軸 (2 )壓縮至一種介於1〇〇〇//ε與.5 0，〇〇〇βε 間之應變程度，槽(J」.7…、8、9 )跟於最小寬度（上1 、h 2、h 3、h 4 )處彈性地閉合。. 1容.如申請專利範圍第11項所述之椎間融合支架 ，特徵在於：該等槽（6、7、8、9 )提供一種寬度（ h 1 ' h 2 ' h 3 h 4 )，而使得一俟支架體（1 )循中心 軸「2 )壓縮至一種介於3000με與1〇 ’ 〇〇〇以 3 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） I J ! I — 1/裝·！訂·—----線 (請先閱讀背面之注意事項再势寫本頁) _ A8 B8 C8 D8 經濟部智慧財產局員工消費合作社印製 六、申請專利範圍 ε間之應變程度，槽（6、7、8、9 )即於最小寬度（ hi、h2、h3、h4)處彈性地閉合。 13·如申請專利範圍第1項所述之椎間融合支架」 特徵在於：槽（6、7、8、9 )提供一種最小寬度^ h」. 、h 2、h 3、h 4 )，寬度値介於 〇 . 〇 2 與 0 . 1 5 mm 之間。 14·如申請專利範圍第1項所述之椎間融合支架， 特徵在於：支架（1)係對稱於含中心軸（2)之一平面 〇 i 1 5'·如申請專利範圍第1項所述之椎間融合支架， 特徵在於:於雨不同高度、H2)之各一處，各設有 總數爲四槽（6、7、8、9)中之爾。 16·如申請專利範圍第1項所述之椎間融合支架， 特徵在於：在較接近於下方接觸面（4 )之高度（H i )處 有兩槽（6、7)係被設置於該周壁（1 0 )之相對扇 區（15、1_6)處。 ,1 7 ·如申請專利範圍第1項所述之椎間融合支架 特徵在於：在較接近於上方接觸面（3 )之高度（H2)處 ，有兩槽（8、9 )係被設置於該周壁（1 0 )之相對扇 區（1 5、1 6)處。 1.& ·如申請專利範圍第1項所述之椎間融合支架， 特徵在於：該等扇區之各者係圍住一介於4 5 °與1 5 0 。間之角度範圍，且最好是介於9 0°與1 2 0°之間。 19·如申請專利範圍第1項所述之椎間融合支架， 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公II ) 請 先 間 讀 背 事 項 艰 寫裝 ^ ； 頁 I I 訂 經濟部智慧財產局員工消費合作社印製 5 Α8 Β8 C8 D8 六、申請寻利範圍 特徵在於:空腔（5)之體稹係爲支架（1)之外表面所 圍合體積之3J1I與7 Q %之閭，且最好是介玲4 0 %與 β 0 %之間。 _ 2 0 ·如申請專利範圍第丄項所述之猶間融，合支架， 特徵在於：於支架（1 )未加載之狀態，檀一C 6、.&、8 ..、9 )提供一種可變化之寬度。 本紙張尺度適用_國國家標準（CNS)A4規格（210 X 297公釐） <請先閱讀背面之注杳？事項再填寫本頁)
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US6395035B2 (en) 2002-05-28
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AU2151099A (en) 2000-05-08

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