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TWI428114B - 骨骼固定裝置及其系統 - Google Patents

骨骼固定裝置及其系統 Download PDF

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Publication number
TWI428114B
TWI428114B TW095117757A TW95117757A TWI428114B TW I428114 B TWI428114 B TW I428114B TW 095117757 A TW095117757 A TW 095117757A TW 95117757 A TW95117757 A TW 95117757A TW I428114 B TWI428114 B TW I428114B
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Taiwan
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bone fixation
fixation device
rod
thigh
socket member
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TW095117757A
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TW200642654A (en
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Wilfried Matthis
Lutz Biedermann
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Biedermann Technologies Gmbh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7091—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for applying, tightening or removing longitudinal element-to-bone anchor locking elements, e.g. caps, set screws, nuts or wedges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8605—Heads, i.e. proximal ends projecting from bone
    • A61B17/861—Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Description

骨骼固定裝置及其系統
本發明係關於骨骼固定元件柄部連接於桿所用承座件，以及具有如此承座件之骨骼固定元件，可用於脊椎手術或外傷手術。
已知之多軸骨骼螺釘100如第11圖所示。包括承座件101，供螺釘元件102連接於桿103，承座件的外壁實質上呈圓筒形。承座件101有實質上呈U形斷面之凹部104，形成二開口股部105,106，界定凹溝，供桿103插入。該股部設有陰螺紋107，承受安全螺釘108，把該桿固定於凹溝內。陰螺紋107為公制螺紋。
當安全螺釘108旋入時，如第13圖所示，力量是徑向朝外，如箭頭A所示，作用於該陰螺紋，造成該股部105,106歪斜。如此會使桿的固定鬆弛。
迄今已有若干措施，解決股部歪斜的問題。一種解決方式是提供管狀抗衡工具。另一解決方式包含提供外螺幅，螺合在該股部之陽螺紋，正如EP 0 614 649 A所載。又，外部環形安全機構亦已公知。然而，諸如外螺幅或環等安全機構，會加大骨骼螺釘的尺寸，故限制臨床的應用。
又一措施包含陰螺紋107使用一種特殊螺紋形狀，而安全螺釘為相對應螺紋。已知使用鋸齒螺紋(如US 5,005,562所示)或反向角度螺紋(如US 6,296,642 B1或US 2002/0138076 A1所示)，以消除作用於該股部之朝外徑向力量。特別有益的螺紋形狀是US 2003/0100896 A1所示平坦螺紋，完全消除徑向力量，且容易製造。使用此等螺紋形狀可用骨骼螺釘，不需其他外部安全裝置，諸如外螺幅或環。
然而，儘管有上述策略，在安全螺釘最後旋緊時，股部仍有對角歪斜的問題。此項歪斜主要是在最後旋緊時，因螺 腹間的摩擦，造成該股部的對角側向變形，而作用於該股部105,106之扭矩所致。該項變形如第14圖所示，為了簡明起見，安全螺釘略而不示。股部歪斜的問題不限於多軸骨骼螺釘，亦發生在所謂頂部開口式固定元件，包含單軸螺釘(有二開口股部，中間有間隙，供桿插入)。
如第12圖所示，在橫越凹溝導向的承座件側面設有壓平表面109，仍未能解決問題，但有助於在桿的縱向減小骨骼螺釘之尺寸。
本發明之目的，在於提供一種承座件，尤其多軸骨骼固定元件所用者，以及連接於桿之骨骼固定元件，使用安全，同時設計精巧。又一目的在於提供如此骨骼固定元件之保持和/或導引工具。
此目的是由申請專利範圍第1項之承座件、申請專利範圍第16項之骨骼固定元件，以及申請專利範圍第17項之工具所達成。進一步的發展列於申請專利範圍附屬項。
本發明承座件的優點是，防止股部歪斜，不用任何外部安全機構。在該桿縱軸平行方向尺寸減小。所以，較已知螺釘更為精巧。若在桿的縱軸平行方向以習知螺釘的同樣尺寸設計，則可用較習知螺釘更大的直徑。
本發明其他特點和優點，由參照附圖所示具體例之說明即可明白。
如第1圖、第2圖、第3a和3b圖所示，本發明骨骼固定元件51的柄部50連接於桿所用承座件1，包括第一端2和第二端3、中心軸線，以及具有實質上U形截面之凹部4。凹部4從第一端2朝第二端3延伸，形成二股部5,6，在第一端2開口。凹部界定凹溝，具有縱軸線L，供桿7插入。桿7插入時，縱軸線L相當於桿7之縱軸線。凹部4寬 度大到剛好夠桿置入，並套接到凹部之底8，而在未固定時，仍能在凹部內進行滑動。桿插入時，股部5,6突出到桿上方，有陰螺紋9從鄰近第一端2的位置，按第二端3的方向延伸跨越預定長度，容許安全螺釘10旋入把桿固定。陰螺紋9和安全螺釘的匹配陽螺紋，以平坦螺紋為佳，其上、下螺腹各與螺釘軸線呈90度角。
在股部5,6的外壁表面，設有二對立平坦表面11,12，與凹溝的縱軸線L，以及承座件的中心軸線，平行延伸。平坦表面11,12彼此平行，從接近第一端2的第一位置，朝位於凹部4底下方的第二端3之第二位置延伸。因此，平坦表面11,12沿該股部從兩側包圍桿之部份延伸。承座件1又在橫越凹部縱軸線L的側面，包括二對立平坦表面13,14，從距第一端2一段距離，延伸至凹部底8下方之位置。平坦表面13,14彼此並且與中心軸線M平行。如此一來，平坦表面11,12和平坦表面13,14分別包含90°角。在圖示具體例中，平坦表面11,12,13,14按中心軸線M垂直方向之寬度W相同，故接近凹部底8的承座件沿周方向之封包E，呈實質上方形。
在股部5,6的側邊，設有部位15,16,17,18，其壁厚較平坦表面11,12區域內之股部壁厚增加。此等部位形成加強結構，防止股部因對角歪斜而彎曲。具有增加壁厚的部位15,16,17,18有第1和2圖所示之平坦外表面，或圓滑表面。可沿平坦表面11,12,13或14之全長延伸，或如第1和2圖所示，越過斜部19，其壁厚朝第一端2漸減。
第3a圖和第3b圖表示本發明承座件連同骨骼螺釘51，形成多軸骨骼固定元件。在此情況下，承座件1如第3a圖所示，又包括共軸徑孔20，延伸貫穿凹溝底部8，在一段21朝第二端3斜縮，在第二端3提供開口22，其直徑較徑孔20為小。該徑孔20的直徑較螺絲元件51的頭部52直徑大，使骨骼固定螺釘51的柄部50和螺釘頭52，可導經該徑孔。開 口22直徑較螺釘頭部52直徑小，但比柄部50直徑大。因此，斜縮段21和螺釘頭部52形成球窩結合，可撓性連接骨骼固定螺釘和承座件。
設有加壓元件25，可在徑孔20內滑動，並用於對頭部施壓，在加壓對頭部施壓時，可在螺釘元件固定在相對於承座件之角度位置。加壓元件可實質上為圓盤形，具有可包容螺釘頭部上方的凹部，以及容納桿7下側之凹部。加壓元件亦可具有開口，容許旋入工具可引導穿過。
由第3b圖可見，具有增加壁厚的承座件部位15，在桿插入承座件內時，位於大約桿縱軸線之高度，而平坦表面延伸越過桿被股部5,6從兩側包圍之面積。
操作時，把螺釘元件和加壓元件插手承座件內。然後把桿置入，利用安全螺釘加以固定。在圖示具體例中，當內螺桿旋緊時，桿對加壓元件施壓，而螺釘頭部和桿即同時固定。
如第2圖內箭頭B所示，作用於股部的扭矩更為均勻分佈，故可幾何全然防止股部之對角歪斜。
第4a圖和第4b圖簡略表示按照本發明增加股部5,6強部之原理。在第4a圖所示習知承座件內，股部在橫越中心軸線M方向的截面形狀，有如圓筒截面。股部外壁在凹部4縱軸線L平行方向壓平，以產生平坦表面11,12，把壁厚減到最靠近中心軸線M的位置。厚度d較股部側邊區域內的壁厚為小。表面在垂直於凹部4縱軸線L進一步壓平，產生平坦表面13,14，消除銳邊30，在股部側邊發生有增加壁厚D之部位15。如此提供加強結構，以防股部對角歪斜。以下實施例說明本發明承座件達成之效果。使用直徑drod 5.5mm和陰螺紋部內徑7mm的桿，則本發明承座件在橫越桿的方向之側向寬度Wmax ，從習知承座件的13mm減至11.5mm。本發明承座件之幾何形狀的慣性力矩(為螺腹剛性之量度)增至 380mm4 ，相較於習知情況之240mm4 。
減少側向寬度Wmax 可構成更具解剖形狀之骨骼固定元件下側，有助於減少在刻面接合之負荷和/或接觸。
反之，若本發明承座件的側向寬度Wmax 和習知圓筒形承座件相同，則本發明承座件可具有較大凹部4，可用於較大直徑之桿，而不降低剛性。
承座件1可藉提供圓筒形組件而製成，並利用銑工而製成平坦表面。
本發明不限用於第3a圖和第3b圖所示骨骼固定元件之承座件。其他多軸連接亦可用，例如頭部和桿可分別固定。在此情況下，設有分開的桿固定機構和頭部固定機構。又，在圖示具體例中，螺釘頭部和斜縮段呈球形，但其他任何形狀均屬可行，只要骨骼固定元件頭部和斜縮段有球窩接頭的功用即可。例如，斜縮段可呈錐形。
本發明也不限於多軸骨骼固定元件，亦可應用於單軸骨骼固定元件。在此情況下，承座件之第二端3固定連接於要固設於骨骼之柄部。
柄部可為螺紋柄部，如圖所示，亦可為銷、鈎，或適於固設在骨骼之其他元件。
陰螺紋可具有任何形狀，然而以能夠減少徑向朝外力量者為佳。
承座件的第二具體例，如第5a圖和5b圖所示。第二具體例與第1至3b圖所示第一具體例不同，在於與平坦表面11,12相對應之表面11’,12’並非平坦，而是呈凹曲面形，而在凹曲面11’,12’外邊具有增加壁厚的部位15’，沿股部全長延伸至第一端2。雖然剛性較第一具體例低，但股部的歪斜仍然因第二具體例之承座件而大減。第二具體例的承座件之優點是，凹曲面有利於外科醫師之握取承座件。
承座件之第三具體例見第6a和6b圖。第三具體例與第 1至3b圖所示不同，在於平坦表面11,12設有縱向肋條115，按橫越凹溝的縱軸線L之方向，具平行之承座件的中心軸線M，在平坦表面上全面延伸。縱向肋條方便握取承座件。
其他變化均屬可行。肋條不需延伸於股部之全體外表面。又，第二具體例在凹曲面11’,12’上亦可具有如此縱向肋條。甚至亦可在構想在已知承座件的習知凸曲面形外表面設有肋條。
進一步變化是，在形成承座件的基本材料，添加一種或多種額外材料，以強化基材材料，而實現加強結構。可例如添加纖維，像碳纖，或加玻璃粒。
第7圖表示使用多軸螺釘的承座件之習知對抗保持工具。對抗保持工具有握部30，容許旋入工具導引通過之空心傳動軸32，以及可供使用習知圓筒形承座件之圓形保持部33。保持部具有對立細縫34，套合於桿上，在陰螺紋旋入時，容許承座件對抗保持。
按照本發明，對抗保持工具的保持部適應承座件之形狀。第8圖表示本發明對抗保持工具用之保持部40。保持部40具有實質上方形輪廓，空心內部有開口43，可連接至對抗保持工具之空心傳動軸，在對立側有二凹部41，在桿插入時，可套合在承座件上。保持部40又有二對立平行表面42，與承座件之平坦表面11,12合作，提供形式套合連接。對抗保持工具特別適於經表皮應用，以最少的侵襲性手術進行。利用保持部和承座件間之形式套合連接，即可準確對準承座件。
第9圖表示套管針之習知管件，供最少侵襲性手術之用，具有圓形截面。第10圖表示本發明套管針之管件，其形狀適應承座件之形狀，實質上為方形。以第9圖之管件，由於承座件和管件間之形式套合連接，利用經表皮引進骨骼固 定元件，可以準確引進和對準。
1,101‧‧‧承座件
2‧‧‧第一端
3‧‧‧第二端
4,104‧‧‧凹部
5,6,105,106‧‧‧股部
7‧‧‧桿
8‧‧‧凹溝底部
9,107‧‧‧陰螺紋
10,108‧‧‧安全螺釘
11,12,13,14‧‧‧平坦表面
15,16,17,18,15’‧‧‧加厚部
19‧‧‧傾斜部
L‧‧‧縱軸線
M‧‧‧中心軸線
W‧‧‧寬度
E‧‧‧封包
20‧‧‧共軸徑孔
21‧‧‧斜縮段
22‧‧‧開口
25‧‧‧加壓元件
d‧‧‧厚度
30‧‧‧銳邊
D‧‧‧壁厚
drod ‧‧‧直徑
Wmax ‧‧‧側向寬度
11’,12’‧‧‧凹曲面
30‧‧‧握部
32‧‧‧空心傳動軸
33‧‧‧圓形保持部
34‧‧‧細縫
40‧‧‧保持部
41‧‧‧凹部
42‧‧‧平行表面
43‧‧‧開口
50‧‧‧柄部
51,100‧‧‧骨骼固定螺釘
52‧‧‧螺釘頭部
102‧‧‧螺釘元件
103‧‧‧桿
109‧‧‧壓平表面
A‧‧‧箭頭
115‧‧‧縱向肋條
第1圖表示本發明第一具體例承座件透視圖；第2圖表示第一具體例承座件俯視圖；第3a圖表示骨骼固定元件連同第一具體例承座件之斷面圖；第3b圖表示骨骼固定元件連同第一具體例承座件之透視圖；第4a和4b圖簡略表示承座件第一具體例具有加強結構之原則；第5a圖表示本發明第二具體例承座件開口股部簡略斷面圖；第5b圖表示第二具體例承座件之透視圖；第6a圖表示本發明第三具體例承座件開口股部簡略斷面圖；第6b圖表示第三具體例承座件之透視圖；第7圖表示對抗保持工具之側視圖；第8圖表示本發明對抗保持工具之保持部透視圖；第9圖表示習知套管針工具之透視圖；第10圖表示本發明套管針工具之透視圖；第11圖表示習知多軸骨骼螺釘之透視圖；第12圖表示修飾過的習知多軸骨骼螺釘之透視圖；第13圖表示說明習知承座件所引起問題之簡略斷面圖；第14圖表示說明習知承座件所引起另一問題之簡圖。
1‧‧‧承座件
2‧‧‧第一端
3‧‧‧第二端
4‧‧‧凹部
5,6‧‧‧股部
8‧‧‧凹溝底部
9‧‧‧陰螺紋
11,13,14‧‧‧平坦表面
15‧‧‧加厚部
19‧‧‧傾斜部
L‧‧‧縱軸線
M‧‧‧中心軸線

Claims (12)

  1. 一種骨骼固定裝置，包括供一骨骼固定元件的一柄部連接於一桿所用之一承座件(1)，一桿(7)和一安全元件(10)；該承座件(1)包括：一第一端(2)和一第二端(3)；具有實質上U形截面之一凹部(4)，該凹部(4)從該第一端(2)按該第二端(3)方向延伸，形成二股部(5,6)，在該第一端(2)開口，該凹部(4)界定一凹溝以承受該桿(7)，該凹溝具有一縱軸線L；該股部(5,6)有一陰螺紋(9)，以承受具有一陽螺紋可與該陰螺紋嚙合以保固桿之該安全元件(10)；其中該承座件(1)係可多軸向連接於該骨骼固定元件，有一徑孔(20)從該第一端(2)延伸至該第二端(3)，供貫穿該骨骼固定元件之該柄部，該徑孔具有一中心軸(M)，設有一加壓元件(25)，可在該徑孔(20)內滑動，施壓於該骨骼固定元件之一頭部，把該骨骼固定元件固定在相對於該承座件之角度位置，其特徵為：該股部(5,6)設有加強結構(11,12,15；11’,12’,15’；115)；由該股部(5,6)外緣增加壁厚(D)所形成，其中增加壁厚(D)大於該股部(5,6)在最近該徑孔中心軸線(M)位置之壁厚(d)，其中該壁厚係就該中心軸線(M)徑向測量，且其中增加壁厚(D)係位在該桿插入該承座件內時的該桿縱軸線高度，又其中該加強結構越過傾斜部，朝該承座件之該第一端(2)漸減壁厚者。
  2. 如申請專利範圍第1項之骨骼固定裝置，其中該加強結構形成於該股部(5,6)之外壁者。
  3. 如申請專利範圍第1或2項之骨骼固定裝置，其中該加強結構包括對立平坦表面(11,12)，各該表面形成於一股部 (5,6)之外壁，該表面係與該凹溝之該縱軸線(L)平行者。
  4. 如申請專利範圍第3項之骨骼固定裝置，其中該平坦表面(11,12)係在該U形凹部(4)底之下方延伸者。
  5. 如申請專利範圍第3項之骨骼固定裝置，其中該平坦表面(11,12)實質上延伸至該第一端(2)者。
  6. 如申請專利範圍第1項之骨骼固定裝置，其中在該縱向凹溝之垂直側設有對立平坦表面(13,14)者。
  7. 如申請專利範圍第1項之骨骼固定裝置，其中該承座件(1)之一沿周封包(E)呈方形者。
  8. 如申請專利範圍第1項之骨骼固定裝置，其中該加強結構係增加壁厚之肋條般斷面(15；15’；115)者。
  9. 如申請專利範圍第8項之骨骼固定裝置，其中該肋條般斷面(15’；115)實質上按該第一端(2)之方向延伸至該第二端(3)者。
  10. 如申請專利範圍第8項之骨骼固定裝置，其中該加強結構設置位置可從兩側包圍該桿者。
  11. 如申請專利範圍第1項之骨骼固定裝置，其中該股部(5,6)的側邊包括增加材料厚度之一斷面(15；15’)者。
  12. 一種系統，包括申請專利範圍第1-11項任一項之一種骨骼固定裝置，和供保持或導引該承座件之一工具，該工具具有保持或導引部，其中該加強結構包括對立平坦表面(11,12)，各該表面形成於一股部(5,6)之外壁，該表面係與該凹溝之該縱軸線(L)平行，又其中該保持部(40)有二對立平行表面(42)，其該承座件之該平坦表面(11,12)合作，以提供型套連接者。
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KR101154037B1 (ko) 2012-06-07
EP1726264B1 (en) 2009-05-20
JP2012183328A (ja) 2012-09-27
TW200642654A (en) 2006-12-16
EP1726264A1 (en) 2006-11-29
JP2006326308A (ja) 2006-12-07
ES2326123T3 (es) 2009-10-01
US20130030477A1 (en) 2013-01-31
KR20060122724A (ko) 2006-11-30
US20060293666A1 (en) 2006-12-28
EP2085040B1 (en) 2012-05-23
CN102599968A (zh) 2012-07-25
US9585696B2 (en) 2017-03-07
US8262704B2 (en) 2012-09-11
CN1868413B (zh) 2012-05-30
DE602005014545D1 (de) 2009-07-02
EP2085040A1 (en) 2009-08-05
CN1868413A (zh) 2006-11-29
JP5073964B2 (ja) 2012-11-14

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