TWI480020B - 穩定骨骼結構用之桿狀植入體及脊椎穩定裝置 - Google Patents
穩定骨骼結構用之桿狀植入體及脊椎穩定裝置 Download PDFInfo
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- 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, setting implements or the like
- 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 ; Bone 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
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Description
本發明係關於特別指穩定脊柱用之桿狀植入體,以及含有此桿狀植入體之脊椎穩定裝置。桿狀植入體包含撓性桿,至少部份由彈料性材料製成,又含有補強桿,以強化植入體,尤其是對抗脊柱在軸向轉動,並抵抗剪力。脊椎穩定系統包括該桿狀植入體,和要連接於桿狀植入體之至少二骨骼固定元件。
EP 0 669 109 B1記載一種穩定裝置,供穩定相鄰胸椎。此裝置包括二單軸向梗釘,和利用夾釘固設於各梗釘容納構件內之狹條;以及支持元件,安裝於狹條上,設計成抗壓體。惟穩定裝置不具有扭曲堅固性,無法軸向延伸。此外,單軸式梗釘之使用,限制到穩定裝置之應用。
US 2007/0093820 A1揭示一種動態脊椎穩定裝置,包括彈料性材料製之撓性桿,夾持於單軸式骨骼螺釘之容納件內。EP 1 795 134 A1和EP 1 900 334 A1記載一種脊椎穩定系統,具有撓性彈料桿和多軸式骨骼螺釘。
包括撓性彈料桿的動態穩定系統,適於控制(尤其是阻尼)脊柱運動節段的軸向壓縮和延伸。彈料性材料有益於藉裁切彈料桿而得適當長度之桿狀植入體,而且植入體製造簡單。
在椎間盤早期變性或部份受損或受傷之臨床情況下,脊柱之相對應運動節段,會遭受到增加轉動和剪力。此等轉動和剪力會造成強烈疼痛。
US 2007/049937 A1揭示一種桿狀植入體,包括金屬性空心桿,有撓性段,在桿壁呈蝸形凹部形式。在空心桿裡設有縱向芯部,固設於桿之一端,可相對於桿的另一端運動。脊柱剪力運動造成桿狀植入體的糾結問題,即大為減少。
本發明之目的,在於提供脊柱用植入體和穩定系統,特別適用於需抑制脊柱的轉動和剪力運動之情況。
此目的係由申請專利範圍第1項之植入體,和申請專利範圍第12項之穩定系統解決。進一步發展則列在申請專利範圍附屬項內。
本發明桿狀植入體有彈料桿之優點,諸如方便製造和處理,但較純彈料桿卻又增加穩定性,且為一種模組系統,得使彈料桿和補強桿有各種組合。
桿狀植入體和穩定系統因使用彈料桿,可使軸向伸張和壓縮運動有動態阻尼,並因補強桿大為增進阻力,對抗轉動和/或剪力和/或彎曲運動。
其他特點和優點由如下參照附圖所示具體例之詳細說明,即可明白。
如第1和2圖所示,穩定裝置1包括桿狀植入體2和複數骨骼固定元件3。骨骼固定元件可固定於骨質結構內,尤其是脊柱的相鄰椎骨。桿狀植入體2可連接於骨骼固定元件,後者即固定於椎骨內。因此,桿狀植入體2的總長度,可跨越脊柱至少二椎骨之距離。
在圖示具體例中,桿狀植入體係由圓筒桿20形成,包括第一端2a和第二端2b。共軸徑孔21從第一端2a延伸至第二端2b,貫穿圓筒形桿20。在此具體例中,共軸徑孔呈圓形截面。
在共軸徑孔21內容納補強桿22,呈圓形截面,其直徑尺寸使補強桿22可在共軸徑孔21內滑動。補強桿22從第一端2a延伸到至少第二端2b,可突出超過圓筒桿20之第二端2b。在一端,例如第一端2a,補強桿22被止動件23限定其對桿20之相對運動。止動件23可例如形成圓盤,安裝於補強桿之末端。止動件23可構想不其他構造。例如,止動件可沿補強桿22的端部調節。例如可在補強桿22端部外表面設螺紋,並以螺帽螺合於螺紋端部,頂住圓筒桿22的端部2a(圖上未示)為之。
補強桿可在第二端2b運動。惟亦可在離第二端2b一段距離處設第二止動件(圖上未示)。第二止動件可以調節。若有第二止動件,則第一止動件和第二止動件間之距離,比第一端2a和第二端2b間之距離大,故補強桿22可自由運動。
桿20的材料是塑膠材料,桿20受到軸向作用之壓縮或張力時,會顯示撓性。特別適用的是,顯示此項撓性之聚合物材料,尤其是彈料性材料,諸如聚胺酯、聚碳酸酯胺酯(PCU),或聚矽氧烷。惟顯示如此彈性特點的任何其他材料均適用。由於材料顯示撓性性能,圓筒桿20亦反應在繞桿軸線之轉動力,和對桿軸線有垂直分力的剪力。如此力量是起自脊椎運動節段的扭力和剪力運動。
為控制和阻尼轉動力和剪力,補強桿22是由撓性比圓筒桿20遜,或在沿桿軸線作用力下未顯示撓性之材料製成。特別適用材料係身體相容性金屬,諸如不銹鋼、鈦或鈦合金,像鎳鈦諾(Nitinol),或硬質塑膠材料,例如PEEK,或碳纖強化PEEK等等。
補強桿22可塗佈以方便在圓筒桿20的共軸徑孔內滑動。另外,可設滑動導引或滑動軸承,以方便補強桿滑動。
骨骼固定元件3可為任何單軸式螺釘或骨骼鈎,惟以第1和2圖所示多軸式骨骼螺釘為佳。多軸式骨骼螺釘3包括螺釘元件31,有螺紋幹部,和球形頭部,樞動保持於容納桿的容納件32內。為把螺釘元件31固設於與容納件32相對之所需角度位,設壓力元件33,作用於螺釘元件31之頭部。桿狀植入體2容納在容納件32內,利用固設元件34加以固設。
第3和4圖表示骨骼固定元件30,特別適用於桿狀植入體。骨骼固定元件30包括螺釘元件31,有螺紋幹部和球形頭部,以及容納件32,以容納桿狀植入體2。容納件呈實質上圓筒形或立方形,包括共軸徑孔32a,從一端延伸至相反端,並朝一端斜縮,以樞動容納螺釘元件31之螺釘頭部。容納件32又包括U形凹部32b,以容納桿狀植入體2。
設有第一壓力元件33,實質上圓筒形,可在徑孔內運動。壓住螺釘元件之頭部,有U形凹部33b,以容納桿狀植入體2。U形凹部33b深度,使桿狀植入體2插入時,壓力元件在桿狀植入體的表面上方延伸。
設有固設螺釘34,可從U形凹部32b的自由端旋入容納件32內。
此外,設有第二壓力元件35,以固設螺釘34向下壓。
第一壓力元件33和第二壓力元件35形狀,使桿狀植入體2包容在其間,並固設於軸向,不壓在補強桿22上。所以,補強桿仍然能運動。固設螺釘34亦壓到第一壓力元件33,把螺釘元件31的頭部固設於容納件內,與桿狀植入體的固設分開。
與桿狀植入體接觸的第一壓力元件33和第二壓力元件35之表面,有結合結構,與桿的表面結合,無損桿狀植入體之表面結構。
第5和6圖表示補強桿以及彈料桿20相對應徑孔之截面變化例。第5圖表示修飾之桿狀植入體2',與前述具體例的桿狀植入體2不同處是,補強桿22'的截面為長方形,而桿20內相對應徑孔亦呈長方形截面。在第5圖所示具體例中,桿狀植入體2'的配置是,使補強桿22'的長方形之長側,對齊垂直於螺釘元件31之軸線。然而,任何其他定向亦可行。在第6圖所示修飾例中,補強桿22"的截面是十字形。
可構思他種截面的補強桿,例如多角形截面。對抗轉動和/或剪力和/或彎曲力的阻力,可藉使用非圓形截面的補強桿而增進。此外,如有必要,桿狀植入體可用非圓形截面之補強桿,具備定向依賴性之彎曲撓性。
第7和8圖表示修飾之骨骼固定元件300,與骨骼固定元件30不同的是,壓力元件33'有U形凹部33b,其深度使桿狀植入體插入時,壓力元件只突出到稍微超出桿狀植入體2表面。在U形凹部的底部,設有一或若干銷形凸部36,結合桿狀植入體2之表面。
固設元件34'是二件式固設元件,有外螺釘37和內螺釘38。外螺釘37旋入容納件32內,壓在壓力元件33'上,以鎖定螺釘元件31在容納件內之角位。內螺釘38在朝桿狀植入體2的側面有銷形凸部39。內螺釘38連同凸部36夾持桿狀植入體2,與螺釘元件31的頭部固設於容納件32內分開。銷形凸部36和39的維度,以及固設元件34'的內、外螺釘之維度,使得只有桿20被夾持,而補強桿22仍可自由運動。
使用時,首先將至少二骨骼固定元件插入各椎骨內。然後,決定桿狀植入體之必要長度,從彈料桿和補強桿組之桿,裁切適當的桿狀植入體。必要時,在一端或二端含有止動件。
然後,把桿狀植入體插入骨骼固定元件之容納件內。調節椎骨彼此相對位置,把螺釘元件31相對於容納件之多軸位置鎖定。調節容納件之距離後,把桿狀植入體固設。
1...穩定裝置
2...桿狀植入體
2a...桿狀植入體第一端
2b...桿狀植入體第二端
3...骨骼固定元件
20...圓筒形桿
21...共軸徑孔
22...補強桿
23...止動件
30...骨骼固定元件
31...螺釘元件
32...容納件
32a...共軸徑孔
32b...U形凹部
33...第一壓力元件
33b...U形凹部
34...固設元件
35...第二壓力元件
36...銷形凸部
37...外螺釘
38...內螺釘
39...銷形凸部
第1圖是穩定系統取自沿桿軸線之簡略斷面圖;
第2圖是穩定系統簡略側視圖;
第3圖是適合桿狀植入體的骨骼固定元件之簡略透視圖;
第4圖是第3圖骨骼固定元件具有插入桿狀植入體沿垂直於桿軸線之簡略斷面圖;
第5圖是第3圖骨骼固定元件具有修飾桿狀植入體之簡略斷面圖;
第6圖是第3圖骨骼固定元件具有又一修飾桿狀植入體之簡略斷面圖;
第7圖是骨骼固定元件修飾成適合桿狀植入體之簡略透視圖;
第8圖是有桿狀植入體插入的第7圖骨骼固定元件沿垂直於桿軸線之簡略斷面圖。
1...穩定裝置
2...桿狀植入體
2a...桿狀植入體第一端
2b...桿狀植入體第二端
3...骨骼固定元件
20...圓筒形桿
21...共軸徑孔
22...補強桿
23...止動件
31...螺釘元件
32...容納件
33...第一壓力元件
34...固設元件
Claims (12)
- 一種穩定骨骼結構用之桿狀植入體,尤指脊柱用,該桿狀植入體(2,2',2")包括:一桿構件(20),有一第一端(2a)和一第二端(2b),以及一縱向軸線,該桿構件係至少部份由顯示撓性之一彈料性材料製成;一縱向徑孔(21),設在該桿構件內;和一補強桿構件(22,22',22"),容納於該徑孔(21)內,由比該桿構件本身材料更硬的材料製成,其中該補強桿構件係可在徑孔內滑動;一第一止動件(23),設於該補強桿構件之一端部,限制該補強桿構件(22,22',22")的該端部就該桿構件的該第一端(2a)相對滑動,其中該第一止動件(23)可沿該補強桿構件(22,22',22")之該端部調節者。
- 如申請專利範圍第1項之桿狀植入體,其中在該補強桿構件之另一部份設一第二止動件,離該桿構件(20)之該第二端(2b)一距離,其中該第一止動件(23)和該第二止動件間之該距離,大於該第一端(2a)和該第二端(2b)間之距離,使該補強桿構件(22,22',22")可在該桿構件之該第二端(2b)自由運動;又其中該第二止動件可沿該補強桿構件(22,22',22")之該另一部份調節者。
- 如申請專利範圍第1項之桿狀植入體,其中該補強桿構件係由一身體相容性金屬或一身體相容性硬質塑膠材料製成者。
- 如申請專利範圍第1至3項任一項之桿狀植入體,其中該徑孔從該第一端延伸至該第二端者。
- 如申請專利範圍第1至3項任一項之桿狀植入體,其中該桿構件(20)係由塑膠材料製成一整體者。
- 如申請專利範圍第1至3項任一項之桿狀植入體,其中 該補強桿構件(22',22")之截面係非圓形者。
- 如申請專利範圍第1至3項任一項之桿狀植入體,其中該桿構件之材料在沿該縱軸線之壓縮力和伸張力作用下,顯示撓性者。
- 如申請專利範圍第1至3項任一項之桿狀植入體,其中設有機構,以方便該補強桿滑動者。
- 一種脊椎穩定裝置,含有如申請專利範圍第1至3項任一項之一桿狀植入體(2),和至少二骨骼固定元件(3),可連接於該桿狀植入體者。
- 如申請專利範圍第9項之脊椎穩定裝置,其中該骨骼固定元件至少其一係一多軸式螺釘(3),包括一螺釘元件(31),可在容納該桿狀植入體(2)之一容納件(32)內樞動者。
- 如申請專利範圍第10項之脊椎穩定裝置,其中該多軸式螺釘係設計成,該螺釘元件(31)相對於該容納件(32)之位置,可與該桿狀植入體(2)之固設,獨立鎖定者。
- 如申請專利範圍第10至11項任一項之脊椎穩定裝置,其中該桿狀植入體(2)之固設方式是,在該桿構件(20)被夾持時,該補強桿仍能運動者。
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US9420708P | 2008-09-04 | 2008-09-04 | |
EP08015662A EP2160988B1 (en) | 2008-09-04 | 2008-09-04 | Rod-shaped implant in particular for stabilizing the spinal column and stabilization device including such a rod-shaped implant |
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EP (1) | EP2160988B1 (zh) |
JP (1) | JP2010057917A (zh) |
KR (1) | KR20100028484A (zh) |
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CN101664334A (zh) | 2010-03-10 |
EP2160988A1 (en) | 2010-03-10 |
TW201010664A (en) | 2010-03-16 |
US20100087863A1 (en) | 2010-04-08 |
KR20100028484A (ko) | 2010-03-12 |
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