TWI413506B - 骨骼固定裝置 - Google Patents
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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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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- 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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- 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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- 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
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
- A61B17/7038—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/74—Devices for the head or neck or trochanter of the femur
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/7055—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant connected to sacrum, pelvis or skull
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Description
本發明係關於骨骼固定裝置,尤其可用於穩定骶骨與髂骨區的脊柱之骨骼固定裝置。
在骶骨和骼骨區的脊柱之穩定,需要某種集體,使要與脊柱穩定桿連接之骨釘,可側向螺入骨骼內。
US 6,981,973號揭示一種低擠型椎骨對準/固定總成,包括有半球形頭部之梗釘,設置在有長孔的聯結單位內,其設計在使梗釘可角度調節至90°,一旦桿已插入有長孔的聯結單位內,即可經由單一內部鎖定螺帽,鎖定其位置。螺帽有結合部,其設計在與桿結合。梗釘的頭部利用桿緊壓頭部之作用而鎖定。總成可用釘相對於聯結單位以90°角對準,而固定於腸骨內。
US 2005/0159750 A1號揭示骨骼固定器總成,包括骨骼固定器,和容納構件,以容納脊柱桿。骨骼固定器可在容納件內調節,使骨骼固定器的縱軸線在包含脊柱桿縱軸線的平面,與容納構件相對呈0°至90°角度。此固定器總成的主要用途在於穩定頸椎,必要時可樞動骨骼固定器脫離對準,以免太近而干擾。
US 2005/0154391 A1號揭示一種骨骼固定器,包括骨骼固定器,和容納構件,以容納脊柱桿。容納構件有第一段,以及與骨骼固定器聯結之第二段。第二段可活動連接第一段。骨骼固定器可調節,使骨骼固定器的縱軸線相對於容納構件呈0°至90°角度。
US 6,736,820號揭示一種骨釘,包含有螺紋段和頭部之螺釘構件,以及容納件,容納要與骨釘連接之桿。容納件有開口第一腔孔和實質上U形截面,以容納桿,以及在板端的第二腔孔,具有頭部用的底座。為使釘構件可利用擴大角度樞動到至少一側,限制第二腔孔自由端的邊緣,形成不對稱構造。
US 2003/0055426 A1號揭示一種偏向歪曲骨骼固定總成,包含固定構件和聯結元件,具有與第一縱向軸線共軸之第一腔孔,以及與第二縱向軸線共軸之第二腔孔,其中該第一和第二縱向軸線彼此跨越。聯結元件亦包含桿容納開口,供容納脊柱桿。
本發明之目的,在於提供改進之骨骼固定裝置,容許骨骼固定元件側向固定於骨骼內,例如在適用於脊柱的骶骨和髂骨區的脊柱桿縱向軸線垂直平面,相對於容納件呈至少90°的角度。
此目的是利用申請專利範圍第1項之骨骼固定裝置加以解決。本發明進一步的發展,列於申請專利範圍附屬項內。
本發明骨骼固定裝置之骨骼固定元件,因組件少而精巧,且提供可靠之固定。
容納件之底部和施壓元件表面(與骨骼固定元件的頭部抗衡),最好具有球形表面,相當於頭部表面的球形段。此提供平衡之夾持應力,以夾持頭部。結果,可減少對頭部之夾持應力。
骨骼固定裝置進一步的優點,容許釘相對於容納件之定向角度在90°以上。
本發明其他特點和優點,參照附圖所示具體例詳述如下,即可更為明白。
第1至3圖所示第一具體例之骨骼固定裝置1,包括螺釘構件2,有螺紋軸部3,和頭部4,宜形成球形段,以及容納件5,可容納要與螺釘構件連接之桿100。頭部4在自由端具有凹部4',可與旋動工具結合。容納件5具有第一端6和相對之第二端7,以及對第一端6開口之第一腔孔8,界定第一腔孔軸線9。容納件5又有實質上U形凹部10,界定二自由股部,容納桿100於其間。股部設有陰螺紋11。
容納件又包括第二腔孔12,有第二腔孔軸線13,第二腔孔12與第一腔孔8相通,在第一端6和第二端7間的容納件5側面開口。
第二腔孔軸線13與第一腔孔軸線9相交角度α大約90°±12°,宜稍低於90°,例如85°。角度從容納件5底部測量。第二腔孔12直徑比頭部4最大直徑小,但比螺釘構件2的螺紋軸部3直徑大。鄰接容納件5的外壁,第二腔孔12包括在外壁方向直徑漸增的一段14。直徑可例如以朝外壁加寬的錐形段形狀增加。在第二端7的容納件5底部,設有底座15,定置頭部4的一部份。底座15最好具有球形狀,適合頭部4的球形外表面。
再者,容納件5包括第三腔孔16,有第三腔孔軸線17,第三腔孔16與第一腔孔8相通,對第一端6和第二腔孔12相對的第二端7間之容納件5側面開口。第三腔孔軸線17宜與第二腔孔12的第二腔孔軸線13共軸。第三腔孔17的直徑比頭部4的最大直徑更大,因而比螺紋軸部3直徑大。由於第三腔孔16與第一腔孔8相通,故亦與第二腔孔12相通。
骨骼固定裝置1又包括施壓元件20,具有實質上圓筒形外表面,最大直徑比第一腔孔8的內徑小,其程度使施壓元件20可在第一腔孔8內運動。在朝向第一端7的側面,施壓元件20包括球形凹部21,其形狀適配頭部4之球形表面。在相反側,施壓元件包括圓筒形凹部,其形狀和尺寸在桿插入時,可容納桿100之一部份。又,施壓元件20在具有球形凹部22的末端之圓筒形凹部22圓筒軸線相反側,具有缺口23,當螺釘構件的頭部4部份受到施壓元件20包圍時,容許螺紋軸部3樞動。由第3圖可見,缺口23的尺寸是,即使在骨骼固定裝置呈組裝狀態時,仍可存取於螺釘頭部4之凹部4'。
骨骼固定裝置亦包括鎖釘25,其陽螺紋與容納件的陰螺紋嚙合。
施壓元件20的維度是,在組裝狀態,當螺紋構件2插入容納件5內,且桿100插入施壓元件內,而鎖釘25又尚未旋緊,則施壓元件20的圓筒形凹部22之底部,突出至容納件5的U形凹部底上方。
骨骼固定裝置的組裝是,先把螺紋軸部3引進貫穿第三腔孔16,以及與第三腔孔16相通之第二腔孔12,直至頭部4定置於底座15上。再移動施壓元件20,以其球形凹部21結合部份球形段頭部4。骨骼固定裝置在手術中使用之前,即可以此方式預組合。
使用時,首先把與容納件5和施壓元件20預組合之螺釘構件2,藉旋動工具與頭部之凹部4'結合,達貫穿第三腔孔16,而旋入骨骼內。第一腔孔軸線9與螺釘構件2的縱向軸線包夾的角度約至少α±10°,視第二腔孔12的直徑和直徑漸增段14之尺寸而定。同理,螺釘構件2之縱向軸線,與垂直於第一腔孔軸線9且垂直於桿100的縱向軸線L之軸線,包含角度為±10°。因此,螺釘構件2可在圍繞第二腔孔軸線13的錐體內,以角度範圍±10°樞動。此角度範圍視第二腔孔12和段14之尺寸而定。
一旦桿插入,調節螺釘構件2和容納件5間之角度位置,即將鎖定釘25旋入,對桿100施壓,把桿固定,同時經由桿對施壓構件20旋壓,將螺釘2頭部鎖定位置。
第4圖表示骨骼固定裝置應用於脊柱骶骨和髂骨區之穩定系統。把複數已知固定裝置101各以桿100連接。穩定系統之桿100延伸入骶骨50之區域內。本發明骨骼固定裝置1用於骶骨和髂骨固定。為此目的,螺釘構件2必須從包括桿縱向軸線L和第一腔孔軸線9的平面,以約90°的角度延伸。螺釘構件2可相對於第二腔孔軸線,在上述±10°角度範圍內樞動。
第5至8圖表示骨骼固定裝置之第二具體例。第二具體例之骨骼固定裝置與第一具體例之骨骼固定裝置不同,在於容納件第二和第三腔孔之構造。其餘組件均與第一具體例一致,標示第一具體例同樣之參考號碼,不再贅述。容納件500包括第二腔孔120,與第一腔孔8相通,界定第二腔孔軸線130。一如第一具體例,第二腔孔120對容納件500之側面開口,而第二腔孔軸線130從桿100的縱向軸線和第一腔孔軸線9所界定之平面,以約90°角度延伸。第二腔孔120的直徑比螺釘構件2頭部4之最大直徑還要大,使螺釘構件2的頭部4可通過第二腔孔120引進入容納件500內,直到頭部4定置於容納件500底部之底座15。於第二腔孔120的相反側,設有第三腔孔160,與第一腔孔8相通,界定第三腔孔軸線170。第三腔孔軸線170最好與第二腔孔軸線130共軸。第三腔孔160在側面開口,直徑至少和旋動工具一樣大,可引進與頭部4的凹部4'結合,但直徑要比頭部的最大直徑小,故螺釘構件不會脫出第三腔孔160外。由於第三腔孔160與第一腔孔8相通,故亦與第二腔孔120相通。
骨骼固定裝置1預組裝如第6a和6b圖所示,把螺釘構件2以其頭部4貫通第二腔孔120引進,直到頭部4定置於底座15。然後,在使用中,引進旋動工具,通過第三腔孔160與頭部的凹部4'結合,把螺釘構件2旋入骨骼內。然後,調節螺釘構件相對於容納件500之角度位置,把桿插入,利用旋動螺釘25把裝置鎖定。
在另類使用中,螺釘構件2可旋入骨骼內,容納件500稍後可藉引進螺釘構件頭部,貫穿第二腔孔120,進入容納件500內,而連接於螺釘構件2。
第9至11圖表示骨骼固定裝置第三具體例。骨骼固定裝置與第一具體例骨骼固定裝置不同,只有骨骼固定元件的設計。容納件5一致。骨骼固定元件200包括螺紋軸部3和頭部400。在螺紋軸部3之相反側,頭部包括六角形凸部401,與可經第三腔孔16引進的工具結合。此優點是頭部可製成實心球體或無凹部之球形段。凸部可有適合與工具結合之任何形狀。在又一修飾例中,凸部本身可有凹部,與工具結合。
本發明可以修改,例如在第二具體例中,當螺釘構件2先旋入骨骼內,然後連接於容納件500,即可省略第三腔孔160。第二腔孔的尺寸可以變化,以容許骨釘構件相對於容納件,以加大或減小角度範圍樞動。施壓元件可省略缺口23,只要工具可進出螺釘頭部即可。另外,可以只設一缺口。
為了預組裝,施壓元件20可經捲縮腔孔,與容納件連接。
底座15不需要球形,亦可為其他形狀或平坦。對於封閉機制,亦可為使用單一鎖釘以外之機制。例如可用桿鎖釘和頭部鎖螺帽狀元件組成之鎖定總成。在此情況下,施壓元件有股部突出到桿以上,故施壓元件可獨立於桿壓下。
軸部不需有螺紋,但可有其他任何形狀和結構,得以持留於骨骼內。施壓元件亦可形成平碟狀。
1,101...骨骼固定裝置
2,200...螺釘構件
3...螺紋軸部
4,400...骨骼固定元件頭部
4'...頭部之凹部
5,500...容納件
6...容納件第一端
7...容納件第二端
8...第一腔孔
9...第一腔孔軸線
10...U形凹部
11...自由股部陰螺紋
12,120...第二腔孔
13,130...第二腔孔軸線
14...第二腔孔之一段
15...底座
16,160...第三腔孔
17,170...第三腔孔軸線
20...施壓元件
21...球形凹部
22...球形凹部
23...缺口
25...鎖釘
50...骶骨
100...桿
L...桿的縱軸線
401...六角形凸部
α...第一腔孔軸線和第二腔孔軸線之夾角
第1圖為骨骼固定裝置第一具體例之分解透視圖;第2圖為第1圖骨骼固定裝置組合狀態之斷面圖;第3圖為第1圖骨骼固定裝置組合狀態之側視圖;第4圖為含有本發明骨骼固定裝置之脊椎穩定系統俯視圖;第5圖為骨骼固定裝置第二具體例之分解斷面圖;第6a至6c圖為第5圖骨骼固定裝置總成不同步驟之斷面圖;第7圖為第5圖骨骼固定裝置組合狀態之側視圖;第8圖為第5圖骨骼固定裝置組合狀態轉動180°之側視圖;第9圖為骨骼固定裝置第三具體例之斷面圖;第10圖為骨骼固定裝置第三具體例之後側視圖;第11圖為骨骼固定裝置第三具體例之透視圖。
4...骨骼固定元件頭部
5...容納件
6...容納件第一端
7...容納件第二端
8...第一腔孔
9...第一腔孔軸線
11...自由股部陰螺紋
12...第二腔孔
13...第二腔孔軸線
14...第二腔孔之一段
15...底座
16...第三腔孔
17...第三腔孔軸線
20...施壓元件
21...球形凹部
22...球形凹部
100...桿
L...桿的縱軸線
α...第一腔孔軸線和第二腔孔軸線之夾角
Claims (16)
- 一種骨骼固定裝置,包括:一骨骼固定元件(2;200),有可固定於骨骼之一軸部(3)和一頭部(4);一容納件(5;500),容納要連接於該骨骼固定元件(2)之一桿(100),該桿具有一縱軸線(L);該容納件(5;500)形成單件,包括一第一腔孔(8),該第一腔孔(8)具有一第一腔孔軸線(9),其形狀和尺寸可容納該桿之一凹部(10);一第二腔孔(12;120),該第二腔孔(12;120)具有一第二腔孔軸線(13;130),該第二腔孔係與該第一腔孔(8)相通,其尺寸可容納該頭部(4),該軸部(3)有一部份延伸貫穿該第二腔孔(12;120);其中該第二腔孔軸線(13;130)與該第一腔孔軸線(9)和該桿的縱軸線(L)所界定平面,呈一夾角;以及一施壓構件(20)作用於該頭部,把該頭部相對於該容納件之位置加以鎖定;其中該第二腔孔軸線(13;130)和平面間之夾角為90°±12°者。
- 如申請專利範圍第1項之骨骼固定裝置,其中該第一腔孔軸線(9)和該第二腔孔軸線(13;130)彼此交叉者。
- 如申請專利範圍第1或2項之骨骼固定裝置,其中當該骨骼固定元件定置於該容納件內時,容許該骨骼固定元件樞動者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該第二腔孔(12;120)包括一段(14),其直徑朝該容納件的外壁遞增,在該骨骼固定元件定置於該容納件內時,容許該骨骼固定元件(2)樞動者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該 容納件包括一第三腔孔(16;160),與該第二腔孔(12;120)相通,且配置在該第二腔孔相反側之該容納件側面者。
- 如申請專利範圍第5項之骨骼固定裝置,其中該第二腔孔軸線(13;130)和一第三腔孔軸線(17;170)實質上共軸者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該第二腔孔(12)之直徑,比該頭部(4)之最大直徑為小者。
- 如申請專利範圍第5項之骨骼固定裝置,其中該第三腔孔(16)之直徑,比該頭部(4;400)之最大直徑為大者。
- 如申請專利範圍第5項之骨骼固定裝置,其中該第二腔孔(120)之直徑,比該頭部(4;400)之最大直徑為大者。
- 如申請專利範圍第9項之骨骼固定裝置,其中該第三腔孔(160)之直徑,比該頭部(4;400)之最大直徑為小者。
- 如申請專利範圍第3項之骨骼固定裝置,其中該固定元件是在圍繞該第二腔孔軸線(13;130)的錐體內,以±10°角度樞動者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該凹部(10)係實質上U形者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該容納件包括該頭部(4)用一底座(15),該底座為該第二腔孔表面之一部份者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該底座具有一球形表面部,相當於該頭部(4)之球形表面者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中該施壓構件(20)具有一球形表面部,相當於該頭部(4;400)之球形表面者。
- 如申請專利範圍第1至2項之一骨骼固定裝置,其中 該頭部(400)包括一凸部(401),在與一工具結合用該軸部之相反端者。
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US20070083206A1 (en) * | 2005-09-21 | 2007-04-12 | Microware Precision Co., Ltd. | Self drilling and tapping bone screw |
US7850716B2 (en) * | 2006-02-17 | 2010-12-14 | Warsaw Orthopedic, Inc. | Adjustable interconnection device |
FR2931054A1 (fr) * | 2008-05-13 | 2009-11-20 | Warsaw Orthopedic Inc | Systeme de connecteur spinal et systeme chirurgical spinal l'utilisant |
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2006
- 2006-04-06 ES ES06007324T patent/ES2333146T3/es active Active
- 2006-04-06 DE DE602006009069T patent/DE602006009069D1/de active Active
- 2006-04-06 EP EP06007324A patent/EP1842503B1/en not_active Not-in-force
-
2007
- 2007-04-03 JP JP2007097460A patent/JP5291887B2/ja not_active Expired - Fee Related
- 2007-04-03 KR KR1020070032936A patent/KR101312688B1/ko not_active IP Right Cessation
- 2007-04-03 TW TW096111730A patent/TWI413506B/zh not_active IP Right Cessation
- 2007-04-03 CN CN200710091622XA patent/CN101049257B/zh not_active Expired - Fee Related
- 2007-04-05 US US11/697,220 patent/US8641737B2/en not_active Expired - Fee Related
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2013
- 2013-02-04 JP JP2013019378A patent/JP5695683B2/ja not_active Expired - Fee Related
-
2014
- 2014-01-06 US US14/147,846 patent/US20140222079A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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US20050154393A1 (en) * | 2003-12-30 | 2005-07-14 | Thomas Doherty | Bone anchor assemblies and methods of manufacturing bone anchor assemblies |
TWM285330U (en) * | 2005-08-30 | 2006-01-11 | Microware Prec Co Ltd | Innovated structure for self-tapping bone screw |
Also Published As
Publication number | Publication date |
---|---|
JP2013116336A (ja) | 2013-06-13 |
EP1842503B1 (en) | 2009-09-09 |
US20070265621A1 (en) | 2007-11-15 |
DE602006009069D1 (de) | 2009-10-22 |
US8641737B2 (en) | 2014-02-04 |
KR20070100123A (ko) | 2007-10-10 |
TW200738208A (en) | 2007-10-16 |
CN101049257B (zh) | 2011-05-04 |
US20140222079A1 (en) | 2014-08-07 |
JP5695683B2 (ja) | 2015-04-08 |
CN101049257A (zh) | 2007-10-10 |
KR101312688B1 (ko) | 2013-10-14 |
JP5291887B2 (ja) | 2013-09-18 |
JP2007275592A (ja) | 2007-10-25 |
ES2333146T3 (es) | 2010-02-17 |
EP1842503A1 (en) | 2007-10-10 |
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MM4A | Annulment or lapse of patent due to non-payment of fees |