TWI432171B - 骨骼或脊椎動態穩定用之屈曲性穩定裝置 - Google Patents
骨骼或脊椎動態穩定用之屈曲性穩定裝置 Download PDFInfo
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- 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
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- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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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
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Description
本發明係關於骨骼或脊椎動態穩定用之屈曲性穩定裝置,此裝置包括彈料性材料製之桿構造。
相鄰脊椎穩定用之屈曲性穩定裝置,已載於EP 0 669 109 B1。在此穩定裝置中,置於相鄰脊椎的單軸骨釘,利用彈性帶相連接。此帶以預力方式繫止於骨釘。抗壓縮之支持體,包圍骨釘間之帶,以傳輸壓縮力。支持體、骨釘頭和彈性帶形成一種接頭,使脊椎可有限運動。
US 2003/0220643 A1揭示一種相鄰脊椎體之連接裝置,其中單軸梗釘利用彈簧連接。彈簧使脊柱可屈曲,可有限度的側彎和軸向轉動,同時防止脊柱延伸,不需用橫向構件。套筒置於彈簧上方。套筒和梗釘間之衝擊,有助於彈簧防止脊椎延伸。彈簧長度先預定。不可能由外科醫師適應長度。
WO 2004/105577 A2揭示一種脊柱穩定系統,具備一或以上之屈曲性元件,有開孔或細縫,呈螺旋圖型之形狀。在手術中,系就無法就其屈曲性特性加以調節。
EP 1 364 622 A2記載一種骨骼固定裝置,包括單軸骨釘和屈曲性桿。骨骼固定裝置之彈性特性,是由外科醫師無法加以改變的桿材料和形狀所決定。此外,使用單軸骨釘限制了軸相對於桿的位置調節之可能性。
本發明之目的,在於提供一種骨骼或脊椎動態穩定用之屈曲性穩定裝置,得以改變裝置之彈性特性,同時在手術當中可適應桿構造的長度。
此目的是以申請專利範圍第1項之骨骼固定裝置解決。進一步發展則列於申請專利範圍附屬項。
由內桿和外桿或彈料性材料製套筒構成的屈曲性桿構造,得以調節穩定裝置的彈料特性至很大程度。藉選擇具有彼此不同的適當彈性性能之桿和套筒,即可令桿構造的彈性性能適應特殊脊柱段之運動。尤其是脊柱的屈曲和壓縮,可利用內桿的彈性性能加以控制,而脊柱的延伸可藉選擇適當套筒加以控制。關於屈曲/壓縮和延伸運動之阻尼加以分離,造成脊椎段在構造的運動控制下的合諧行為。結果,可防止骨釘的鬆弛。另一優點是可調節內桿和套筒之長度。因此,提供模組系統,可在手術時間調適。再加上多軸釘,可更加調高調節之可能性。
本發明其他特點和優點,參見附圖所示具體例之詳述,即可顯而易知且最能明白。
如第1a和1b圖所示,屈曲性穩定裝置包括桿構造,含有彈料性材料製的桿20,也是彈料性材料製的套筒40。在圖示具體例中,桿20為圓筒形狀,有光滑表面。由於彈料材料之故,桿是部份或全然屈曲性。例如,桿20由生理相容性塑膠材料製成,諸如以聚胺酯、聚矽氧或PEEK為本之聚合物。特別適用材料為聚碳酸酯胺酯。桿的材料包括充分界定之彈性性能,而桿顯示彎曲彈性、壓縮彈性和拉力彈性。
套筒40之彈料性材料亦為生理相容性塑膠材料,諸如以聚胺酯、聚矽氧或PEEK為本之聚合物,包括彈性性能,可獨立於桿20的彈性性能加以選擇。對套筒而言,也是以聚碳酸酯胺酯特別適用。套筒40呈管狀,包括溝道41,其直徑比桿20的直徑稍大,使桿可插溝道41內,如第1b圖所示。選用套筒40的長度比桿20長度為短,使桿20的第一連接段20a和第二連接段20b,在組合狀態,從溝道41露出,如第1b圖所示。桿20的第一連接段20a和第二連接段20b間之第三連接段20c,容納在套筒40的溝道41內。套筒長度最好大約相當於骨骼固定裝置容納組件間之距離,或是稍大。
茲參見第2至4圖說明,桿20與骨骼固定元件1的容納組件6連接。為便利說明,第3圖中省略套筒40。套筒40置於桿20上,後者再固設於骨骼固定元件1之各容納組件6內。
在此具體例中的骨骼固定元件1為多軸骨釘,含莖部2有骨骼螺紋,在一端之尖部3,和另一端之球形頭部4。在頭部4與莖部相反側,設有凹部5,可與旋入工具結合。容納組件6有第一端7,與第一端對立之第二端8,以及與第一端和第二端的平面交叉的縱軸線9。設有與縱軸線9共軸的腔孔10,從第一端7延伸到離第二端8預定距離處。在第二端8,設有開口11,其直徑較腔孔10直徑為小。鄰近開口11設有球形或其他斜縮截面12,形成球形頭部4底座。
容納組件6又有U形凹部13,在第一端7開始,朝第二端8方向延伸,至離該第二端預定距離處。利用U形凹部13,形成二股部14,15,朝第一端7延伸。鄰近第一端7,容納組件6在該股部14,15包括陰螺紋。
詳見第3圖,設有第一施壓元件17,具有圓筒形構造,其外徑只比腔孔10內徑稍小,使第一施壓元件17可引進入容納組件之腔孔10內,並在軸向移動。施壓元件17在朝向第二端8的下側,包括球形凹部18,其半徑相當於骨釘球形頭部4之半徑。在相反側,第一施壓元件17具有圓筒形凹部19,橫越縱軸線9延伸。選用此凹部之側向直徑,使桿20要容納入容納組件內之圓形截面連接段20a或20b,可插入凹部19內,在其內側向導引。選自圓筒形凹部19的深度,使得桿20的連接段插入並壓緊U形凹部13底部時之組合狀態下,第一施壓元件17即對頭部5施壓。再者,深度以大約桿20連接段直徑之半為佳。由第3圖可見,第一施壓元件17具有共軸腔孔21,供導引旋入工具穿過。
如第3和4圖所示,骨骼固定元件又包括第二施壓元件23,具有第一端24和第二端25。第二施壓元件的寬度,使第二施壓元件可插入容納組件6之U形凹部13內。第二施壓元件的兩側包括二凸部26,套入陰螺紋16限定之空間內,在第二施壓元件插入時,可沿陰螺紋滑動。
由第2圖可見,第二施壓元件23又包括圓筒形凹部27,從第二端25朝第一端24方向延伸,其圓筒軸線垂直於圓筒形凸部26的軸線。圓筒形凸部26在第二端側包括下緣26a。圓筒形凹部27的直徑相當於桿20的連接段直徑,而其深度相當於連接段直徑之半或以下。
骨骼固定元件又包括內螺釘30,可旋入股部14,15之間。陰螺紋16及內螺釘30合作螺紋,可呈任何已知螺紋形狀。平面螺紋或負角度螺紋的優點是,防止股部14,15張開。
容納組件6及第一施壓元件17,在兩側具有相對應縮孔32,33,藉此可將螺釘1、容納組件6和第一施壓元件17可鬆弛組合。如第3和4圖所示,第一施壓元件和第二施壓元件23分別具有凸部22,28,有利於彈性桿20的固定。
屈曲性穩定裝置的其他部份,除桿和套筒以外,由常用生理相容性材料製成,諸如不銹鋼或鈦,或適於骨釘之任何其他材料。
使用上,將至少二骨骼固定裝置固定於骨骼內。其次,選用桿20和套筒40,並組合達成屈曲性穩定裝置之所需彈性性能。若例如二脊椎以上要連接,可選用具有不同彈性性能之不同套筒40,設在不同脊椎之間。如此一來,穩定裝置之彈性性能,可在手術之時適應。最好選擇套筒的長度,相當於梗釘旋入相鄰脊椎內時,二容納組件間之距離。由於桿20和套筒40是彈料性材料製成,在手術當中可縮短。然後,桿20連同套筒40,或者如果有一活動節以上要經由單桿加以穩定,則連同複數套筒,插入骨骼固定元件之容納組件6。最好在二相鄰脊椎的平衡位置,套筒要與容納組件接觸。
然後,把第二施壓元件23插入容納組件內,內螺釘旋入股部之間。調節骨釘的角度位置後,把內螺釘30旋緊。利用內螺釘30對第二施壓元件23所施壓力,把桿20夾持第一和第二施壓元件之間,同時把骨釘的頭部4鎖定於角度位置。
其次,參見第5至8b圖說明屈曲性穩定裝置之彈性性能。在第5圖中表示組合之穩定裝置,以桿20和套筒40配置成把設在形成活動節的相鄰脊椎W內之二多軸梗釘加以連接。梗釘的莖部位置,以虛點線表示。由第5圖可見,骨骼固定元件1的容納組件6,在桿20和套筒40非預力狀態之平衡位置,其距離為x。
第6a圖表示穩定裝置發生屈曲。於屈曲之際,對桿20施以拉應力,造成桿伸長。骨骼固定元件間之距離,增加至x+△x1
。距離增加△x1
,受到桿20因其彈性性能產生恢復力的限制。距離增加可例如在大約1.5 mm範圍。因此,屈曲/壓縮主要受到內桿20的控制。
第6b圖表示穩定裝置發生拉伸,拉伸時,由骨骼固定元件1的容納組件6對桿20和套筒40施以壓縮力。桿20和套筒40的彈性,容許容納組件6間之距離減到x-△x2
。由於桿20和套筒40的彈性性能,恢復力作用於容納組件6,限制距離減小。距離可例如減小約0.5 mm。因此,拉伸受到內桿20壓縮力的控制,被套筒所限制。
在變通應用方式中,套筒在平衡狀態受到預壓縮和/或桿在平衡狀態受到預應力。
第7圖表示桿20和套筒40進行可能之變形。第8a和8b圖表示桿20和套筒40在屈曲(第8a圖)和拉伸(第8b圖)中之變形。
第9a和9b圖表示穩定裝置之應用例。第9a圖表示二相鄰脊椎V,V',再脊椎側彎症情況下,彼此相對中度側向傾斜。為動態穩定和校正如此活動節,可在左、右側使用有不同套筒400,400'之桿200,200',左側桿200所用套筒400長度,較右側桿200'所用套筒400'長度為大。如此一來,可消弭二脊椎在左側的傾斜。此外,套筒400的外徑可與套筒400'不同,以便相對於左側和右側有不同的運動控制。
上述具體例可進一步修飾。在上述具體例中,套筒40有空心圓筒形狀;然而,套筒可有不同形狀。例如可為長胴形,套筒長度可與圖示具體例不同。桿20亦可呈長方形、四方形、橢圓形或三角形截面,或任何其他適當形狀之截面。在此情況下,套筒40的形狀經適當肆應。具體言之,可形成形狀在縱向變化之桿和/或套筒。桿和套筒可形成高度屈曲性或難得屈曲性。
桿和/或套筒的表面可以結構化。第10圖表示具有波紋表面的內桿201例,波紋300設在周緣方向。套筒401內壁有相對應波紋,與桿合作。此舉可防止或減少套筒相對於桿移動。
在上述骨骼固定元件中,骨骼固定元件1的莖部2是多軸向連接於各容納組件6。然而,亦可提供單軸連接。
對內螺釘30,所有已知修飾均可知,亦包含使用外環或螺帽。
在所述具體例內,骨骼固定元件是從頂部引進到容納組件內。然而,骨骼固定元件亦可從容納組件底部引進,只要構造容許。
骨骼固定元件頭部和軸可構成分開組件,加以連接。
本發明不限於螺釘,像骨骼固定元件,亦可以骨鉤或任何其他骨骼固定元件實施。
1...骨骼固定元件
2...莖部
3...尖部
4...球形頭部
5...凹部
6...容納組件
7,24...第一端
8,25...第二端
9...縱軸線
10...腔孔
11...開口
12...斜縮截面
13...U形凹部
14,15...股部
16...陰螺紋
17...第一施壓元件
18...球形凹部
19,27...圓筒形凹部
20,200,200'...桿
20a...第一連接段
20b...第二連接段
20c...第三連接段
21...共軸腔孔
22,28...施壓元件凸部
23...第二施壓元件
26...圓筒形凸部
26a...凸部下緣
30...內螺釘
40,400,400',401...套筒
41...溝道
201...具有波紋表面的內桿
300...波紋
W,V,V'...相鄰脊椎
x...距離
第1a圖表示本發明具體例桿構造之透視分解圖;第1b圖表示第1a圖桿構造呈組合狀態;第2圖表示包括第1a圖桿構造的穩定裝置之分解圖;第3圖簡略表示第1a圖桿容納於多軸骨釘的容納組件內之分解圖;第4圖表示第3圖組合組件之斷面圖;第5圖簡略表示第2圖組合穩定裝置應用於脊柱之相鄰脊椎;第6a圖簡略表示第5圖穩定裝置連同脊柱屈曲中;第6b圖簡略表示第5圖穩定裝置連同脊柱拉伸中;第7圖簡略表示第1b圖桿構造之移動方向;第8a圖簡略表示第6a圖桿構造呈屈曲狀態;第8b圖簡略表示第6b圖桿構造呈拉伸狀態;第9a和9b圖表示應用穩定裝置又一例之俯視圖;第10圖表示桿構造修飾之斷面圖。
1...骨骼固定元件
2...莖部
3...尖部
6...容納組件
20...桿
20a...第一連接段
20b...第二連接段
20c...第三連接段
23...第二施壓元件
24...第一端
25...第二端
26...圓筒形凸部
26a...凸部下緣
27...圓筒形凹部
30...內螺釘
40...套筒
41...溝道
Claims (7)
- 一種骨骼或脊椎動態穩定用之屈曲性穩定裝置,包括:桿構造(20,40;200,400;201,401),包含桿(20;200;201),由具有彎曲彈性,壓縮彈性和拉力彈性之彈料性材料製成,且該桿構造為可調節其長度,桿有第一連接段(20a)、第二連接段(20b)和其間之第三連接段(20c),第一和第二連接段(20a,20b)可分別與第一和第二骨骼固定裝置連接,和套筒(40;400;401),長度比桿長度短,由彈料性材料製成,設在桿第三連接段(20c)之至少一部份,使至少第一和第二連接段(20a.20b)外露,第一骨骼固定裝置(1)和第二骨骼固定裝置(1),與該桿構造連接;其中第一骨骼固定裝置(1)和第二骨骼固定裝置(1)在該桿構造和該套筒係呈無應力狀態之平衡位置有距離(x);當對該桿構造和該套筒施以壓縮力時,該桿構造和該套筒之彈性容許在該第一骨骼固定裝置和第二骨骼固定裝置間之該距離縮減到距離(x-x2),其中由於該桿構造和該套筒之彈力性能,有復原力作用於該第一骨骼固定裝置和第二骨骼固定裝置,以限制該距離之縮減者。
- 如申請專利範圍第1項之屈曲性穩定裝置,其中桿和套筒之彈性性能不同者。
- 如申請專利範圍第1或2項中一項之屈曲性穩定裝置,其中彈料性材料係生理相容性塑膠材料,諸如聚胺酯或聚矽氧者。
- 如申請專利範圍第1或2項中一項之屈曲性穩定裝置,其中套筒內壁與桿表面接觸者。
- 如申請專利範圍第1或2項中一項之屈曲性穩定裝置,其中套筒(40)內壁具有結構(300),與桿(201)表面結構 結合者。
- 如申請專利範圍第1或2項之屈曲性穩定裝置,其中第一骨骼固定裝置和第二骨骼固定裝置至少其一,構成在其莖部(2)和桿(20)間可多軸連接者。
- 如申請專利範圍第1或2項中一項之屈曲性穩定裝置,其中桿包括複數連接段和其間之複數套筒者。
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2005
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- 2005-12-23 DE DE602005008265T patent/DE602005008265D1/de active Active
- 2005-12-23 EP EP05028283A patent/EP1800613B1/en not_active Not-in-force
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2006
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- 2006-12-12 CN CNA2006101659651A patent/CN1985770A/zh active Pending
- 2006-12-13 JP JP2006336131A patent/JP5215553B2/ja not_active Expired - Fee Related
- 2006-12-15 TW TW095146968A patent/TWI432171B/zh not_active IP Right Cessation
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EP1800613A1 (en) | 2007-06-27 |
US20120265247A1 (en) | 2012-10-18 |
EP1800613B1 (en) | 2008-07-16 |
TW200726429A (en) | 2007-07-16 |
US8157843B2 (en) | 2012-04-17 |
CN1985770A (zh) | 2007-06-27 |
KR20070066877A (ko) | 2007-06-27 |
US20140031868A1 (en) | 2014-01-30 |
DE602005008265D1 (de) | 2008-08-28 |
KR101279085B1 (ko) | 2013-06-26 |
US20070233085A1 (en) | 2007-10-04 |
JP2007167642A (ja) | 2007-07-05 |
ES2309646T3 (es) | 2008-12-16 |
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