TWI480018B - 骨骼固定元件及其穩定裝置 - Google Patents
骨骼固定元件及其穩定裝置 Download PDFInfo
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- 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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- A61B17/701—Longitudinal elements with a non-circular, e.g. rectangular, cross-section
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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
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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
- A61B17/70—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
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
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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
- A61B17/7041—Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
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Description
本發明係關於骨骼固定元件及骨骼用之穩定裝置,尤指脊柱用,包括該骨骼固定元件。容納件具有U形凹部,形成凹溝,可供穩定桿插入,另包括側向導件,供納入較小直徑之連接桿。穩定裝置包括至少二骨骼固定元件,和至少一連接桿。骨骼固定元件以多軸式骨骼螺釘為佳。
通常是利用融合籠或骨骼節段穩定裝置,使用硬質桿,更換嚴重受傷或退化的間椎盤或椎骨,以多軸式骨骼螺釘固定於相鄰椎骨內。
在特殊臨床應用中,宜維持脊柱的運動節段有某種活動性。在此等情況下,使用之動態穩定系統,包括骨骼固定元件和撓性桿。例如US 2005/0085815 A1和US 2007/0049937 A1記載動態穩定系統,包括空心金屬桿,有撓性段,由壁上蝸形凹部所形成,在空心桿內並設有芯部。
使用多軸式螺釘和彈料桿的動態穩定裝置,載於EP 1 795 134 A1號。
具有撓性桿的已知穩定裝置,適於脊柱相對於軸向張力和壓縮力的動態穩定和運動控制。
由於脊柱的解剖,需要小型植入體結構物。所以,撓性桿外徑應小,可設計多軸式螺釘之容納件,輪廓低,總體維度小。
在椎間盤早期退化或部份傷害或受傷之臨床情況下,脊椎的相對應運動節段受到增加的轉動和/或增加的剪力。此等轉動和剪力和/或彎曲力,會造成強烈疼痛。此外,金屬或彈料製的撓性桿,不能長時間耐受較大力量,因其直徑小。尤其是,剪力和轉動力會造成撓性桿超載。
本發明之目的,在於提供一種骨骼固定元件和穩定裝置,尤指供脊柱用,適於脊柱呈現增加轉動和剪力運動之情況。
此目的之解決,是利用申請專利範圍第1項之骨骼固定元件,和申請專利範圍第13項之穩定裝置。進一步發展列在申請專利範圍附屬項內。
骨骼固定元件和穩定裝置提高阻力,對抗剪力和轉動力,不礙穩定裝置之軸向阻尼和準確調節,並提供模組系統,容許撓性桿和連接桿之各種組合。
本發明其他優點由如下參照附圖所示具體例之詳述,即可明白。
如第1-5圖所示,第一具體例之骨骼穩定裝置1,包括撓性桿2和至少一側向配置之連接桿3,二者均連接於骨骼固定元件4,4'。
撓性桿2包括至少一部份2a,在沿桿軸線作用的伸縮力作動,以及扭力、剪力和/或彎曲力作動下,顯示撓性。在圖示具體例中,撓性桿2係由硬質材料之空心管製成,諸如身體相容性金屬、合金,尤指鈦、鎳鈦諾、不銹鋼,或硬質之身體相容性塑膠材料,諸如PEEK,或碳纖強化之PEEK。撓性桿之長度,可跨越至少二相鄰椎骨間之距離,在圖示具體例中,是跨越三個相鄰椎骨。撓性部2a設在硬質部2b之間。硬質部2b連接至骨骼固定元件。撓性部之撓性,係由空心管壁上蝸形凹部所達成。惟賦予桿以撓性之任何其他設計均可行。
在撓性桿2之兩側,配置實心連接桿3,其直徑比撓性桿2小。各連接桿3的長度可與撓性桿2相同,或比撓性桿2小。在圖示具體例中,連接桿3並非全直,而是具有第一直段3a、階部3b和第二直段3c。連接桿3宜較撓性桿2之撓性段2a更少撓性。例如,連接桿3係由身體相容性金屬製成,諸如不銹鋼、鈦、鈦合金,諸如鎳鈦諾,或硬質塑膠材料,諸如PEEK,或碳纖強化PEEK。
連接桿3的直徑,遠較撓性穩定桿2為小。然而,連接桿3的直徑尺寸,使連接桿3硬到足以對抗彎曲力。
二側向連接桿3在其各端之一,利用托架5彼此相接,托架5形成向下或向上定向,以夾包撓性桿2。托架5與桿3一體形成,或分開連接於桿3。
骨骼固定元件4設計成多軸式骨骼螺釘之形式。包括螺釘元件,具有螺紋幹部41和球形頭部42;以及容納件43,以容納撓性桿2和連接桿3。容納件43呈實質上圓筒形或立方形,有第一端43a和相對立第二端43b,以及共軸徑孔44,從第一端43a延伸至第二端43b,並朝第二端斜縮,使具有底座,供樞動保持於容納件內的螺釘元件之頭部42用。
詳見第5圖,容納件43包括實質上U形凹部45,從第一端43a按第二端43b方向延伸。利用U形凹部,形成二自由股部46a,46b,連同凹部底,形成凹溝,容納撓性桿2。
在各自由股部46a,46b之壁,設有徑孔47a,47b,形成連接桿之導件。徑孔47a,47b延伸貫穿自由股部46a,46b,故連接桿3可從容納件之一側,引導貫穿徑孔,穿出另一側。徑孔尺寸使直徑比連接桿3的外徑稍大,容許連接桿3在徑孔47a,47b內滑動。
在第2圖所示具體例中,徑孔47a,47b完全位在自由股部46a,46b內,並形成貫穿孔。貫穿孔47a,47b的位置,在撓性桿2插入時,使徑孔軸線在具有撓性桿軸線的平面上。
多軸式骨骼螺釘又包括壓力元件48,呈實質上圓筒形,可在徑孔44內運動,在其面朝頭部42之側面有球形凹部49,包圍頭部之一部份,把壓力分配到頭部42。又包括共軸徑孔50,得以存取頭部42。在球形凹部之相反側,壓力元件48具有圓筒節段形凹部51,其尺寸使撓性桿2可插入,在其內導引。在第2和3圖所示具體例中,圓筒節段形凹部51之尺寸,使撓性桿突出到壓力元件以上。
骨骼固定元件又含有固設螺釘52,與自由股部46a,46b之陰螺紋結合。固設螺釘52用來壓住容納件內之撓性桿2,故間接壓住壓力元件48,施壓於頭部42,鎖定螺釘元件相對於容納件之角度位置。
第3圖表示骨骼固定元件4',係骨骼固定元件之修飾,適於容納第4圖所示連接桿之部位3c。與第2圖骨骼固定元件不同的是,徑孔47a',47b'之構造。此骨骼固定元件之所有其他元件,與第2圖骨骼固定元件相同,不再贅述。徑孔47a',47b'呈半圓形截面。徑孔開向容納撓性桿2之凹溝。連接桿3從容納件內側,利用撓性桿2保固,防其脫出徑孔47a',47b'。以此具體例,可將連接桿3配置於更靠近撓性桿2,而連接桿可通過U形凹溝定位。詳如第1和4圖所示,以此構造可藉撓性桿2和連接桿3彼此間的不同距離,跨越脊柱的若干運動節段。
雖然第一具體例顯示連接桿3,可藉一體形成的托架5彼此連接,但亦可有其他方式。例如,連接桿可用接頭在一端或二端以機械方式連接,係在桿引進入容納件內之後,才應用接頭。其實並不一定要連接,亦可為單桿。為免單桿在滑動過程中脫離容納件,桿3之一端可有較大直徑,以防滑過導件。
雖然圖示連接桿為圓筒形桿,但連接桿的截面可為非圓形,例如橢圓形、多角形或其他形狀。
雖然圖示沿桿軸線的外形,有彎部3b,如第4圖所示,連接桿亦可筆直。
以第2圖所示骨骼固定元件,連接桿可保固於徑孔47a,47b內,以防脫出。在特殊臨床應用上,亦可使用無撓性桿之穩定裝置。
第1圖所示托架3,不但用於連接桿3之連接,亦形成連接桿3滑動之止動件。在相反端離固定元件4一段距離處,亦可設止動件,故連接桿3仍可完全運動。
導件和/或連接桿可設有機構,方便連接桿3滑動。此等機構可為塗料、滑動導件或滑動軸承。
第6-10圖表示穩定裝置之第二具體例,與第1-5圖第一具體例不同處,只有壓力元件480與壓力元件48的比較。壓力元件480可省略撓性桿2,只藉連接桿3提供穩定。所有其他元件和組件,與第一具體例一致,不再贅述。
壓力元件480可有圓筒形部481,取代圓筒節段形凹部51,共軸延伸至壓力元件的主部,直徑較主部為小。圓筒形部481的長度使壓力元件上伸到固設螺釘52,故固設螺釘52旋緊時,把壓力元件480向下壓。此具體例特別適於應用在不必要撓性桿之處。若使用穩定裝置,不需撓性桿,如第6-10圖所示,則可用壓力元件480取代壓力元件48,而第一具體例之所有其他組件保持相同。因此,骨骼固定元件就徑孔47a,47b或47a',47b'之構造保持相同。
第11-12圖表示穩定裝置之第三具體例,與第6-10圖第二具體例不同處,只在省略與桿3連接之托架5。在此情況下,宜在連接桿連端設止動件,容許連接桿在容納件內自由但有限運動。
第13-16圖表示穩定裝置之第四具體例。在此具體例中,使用撓性桿2和全直連接桿3,以托架5連接。在此情況下,連接桿3之組裝,可利用夾持托架,同時引進入容納件內。
第四具體例的骨骼固定元件400,與第一具體例所述骨骼固定元件4不同處,在於導引連接桿3用的導引之位置和設計。自由股部46a,46b外面有凹部470a,470b,朝容納件外側開口。凹部470a,470b的截面係實質上U形,其尺寸使連接桿3可在其內滑動。為防桿3脫出,自由股部46a,46b有支持結構471,支持封閉元件472,例如封閉棒,分別把凹部470a,470b封閉。凹部470a,470b位於和第一具體例之徑孔47a,47b同樣高度。
骨骼固定元件400所有其他部份,與第一具體例一致。須知若不必使用撓性桿2,骨骼固定元件400亦可設有上述壓力元件480。
第17-20圖第五具體例之穩定裝置,具有撓性段的空心管之撓性桿2,改為撓性桿20,由撓性塑膠材料製成,諸如彈料,像聚胺酯、聚碳酸酯胺酯(PCU)或聚矽氧烷。撓性桿20在軸向伸縮作用下,顯示軸向撓性。骨骼固定元件401適於夾持撓性桿20,見第18圖。骨骼固定元件401包括在股部壁上的徑孔47a,47b,正如參見第一具體例所述,與第一具體例的骨骼固定元件不同的是,壓力元件402和固設元件404之形狀。當撓性桿20插入時,壓力元件402在撓性桿20表面上方延伸。在凹部51底,形成凸部403,結合於撓性桿20表面。固設元件404係固設螺釘,一如第一具體例。惟朝向撓性桿20的下側有凸部405,結合於撓性桿20表面結構。利用此構造,撓性桿20被夾持在壓力元件和固設螺釘之間,不將頭部42鎖定於容納件內。旋緊固設螺釘404,即可把頭部鎖定其角度位置,使壓力元件壓在頭部上。
雖然已就各種具體例加以詳述,惟本發明不限於此。各具體例之單一元件可與其他具體例組合。尤其是連接桿3之導件,在所述具體例間可以變化。雖已說明多軸式骨骼螺釘之特殊設計,但其他設計亦可使用,例如具有二件式鎖定元件之多軸式螺釘,螺釘元件從頂或從底加載於容納元件內之多軸式螺釘,有各種形狀的壓力元件把螺釘元件相對於容納件的角位鎖定之多軸式螺釘。
雖然具體例只顯示多軸式螺釘做為骨骼固定元件,亦可構想在單軸式骨骼螺釘的容納件內,提供連接桿用之導件。然而,動態穩定往往需用多軸式骨骼固定元件。
使用時,首先把至少二多軸式固定元件固定於相鄰椎體或骨骼組件。然後,把連接桿插入多軸式骨骼固定元件之導件內,使容納件彼此在軸向對齊。若使用骨骼固定元件具有連接桿用的導件,呈凹部形式代替貫穿孔,則連接桿即可插入U形凹溝內,而夾入凹部,此舉方便骨骼固定元件之連接步驟,再插入撓性桿。撓性桿插入後,調節骨骼元件彼此之位置和距離。最後,旋緊固設元件,把撓性桿固設。
脊柱的運動節段在運動之際,連接桿3可在導件內滑動。連接桿具有阻力,對抗作用於穩定裝置的扭力和/或剪力和/或彎曲力。
1...骨骼穩定裝置
2,20...撓性桿
2a...撓性部
2b...硬質部
3,3',3"...連接桿
3a...連接桿第一直段
3b...連接桿階部
3c...連接桿第二直段
4,4'...骨骼固定元件
5...托架
41...螺紋幹部
42...球形頭部
43...容納件
43a...容納件第一端
43b...容納件第二端
44...徑孔
45...U形凹部
46a,46b...自由股部
47a,47b...徑孔
47a',47b'...徑孔
48...壓力元件
49...球形凹部
50...共軸徑孔
51...圓筒節段形凹部
52...固設螺釘
400,401...骨骼固定元件
402...壓力元件
404...固設元件
403...凸部
405...凸部
470a,470b...凹部
471...支持結構
472...封閉元件
480...壓力元件
481...圓筒形部
第1圖為穩定裝置第一具體例之側視圖;
第2圖為第1圖沿A-A線之放大斷面圖;
第3圖為第1圖沿B-B線之放大斷面圖;
第4圖為第1圖穩定裝置之俯視圖;
第5圖為第4圖穩定裝置沿C-C線之斷面圖;
第6圖為穩定裝置第二具體例之側視圖;
第7圖為第6圖沿A-A線之放大斷面圖;
第8圖為第6圖沿B-B線之放大斷面圖;
第9圖為第6圖穩定裝置之俯視圖;
第10圖為第9圖沿C-C線之斷面圖;
第11圖為穩定裝置第三具體例之俯視圖;
第12圖為第11圖穩定裝置之側視圖;
第13圖為穩定裝置第四具體例沿桿軸線之斷面圖;
第14圖為第13圖沿B-B線之放大斷面圖;
第15圖為第13圖穩定裝置之俯視圖;
第16圖為第15圖穩定裝置之側視圖;
第17圖為穩定裝置第五具體例之側視圖;
第18圖為第17圖沿B-B線之放大斷面圖;
第19圖為穩定裝置第五具體例之俯視圖;
第20圖為第19圖穩定裝置沿A-A線之斷面圖。
3a...連接桿第一直段
4...骨骼固定元件
41...螺紋幹部
42...球形頭部
43...容納件
43a...容納件第一端
43b...容納件第二端
44...徑孔
46a,46b...自由股部
47a,47b...徑孔
48...壓力元件
49...球形凹部
50...共軸徑孔
51...圓筒節段形凹部
Claims (13)
- 一種骨骼尤指脊柱之穩定裝置,包括:至少二骨骼固定元件(4,4',400),包括:一固定段(41),供固定於骨骼內;和一容納件(43),連接於該固定段;其中該容納件(43)包括一開口(45),適於容納具有一桿軸線之一穩定桿(2,20),該開口(45)係沿該桿軸線,受到二側壁(46a,46b)限制;其中該側壁(46a,46b)包括導件(47a,47b;47a',47b';470a,470b),沿該桿軸線定向,供導引至少一連接桿(3,3',3")貫穿;一撓性穩定桿(2,20),容納於該開口(45)內,具有至少一撓性段(2a);至少一連接桿(3),於該容納件內所設該導件內導引,並連接於該二骨骼固定元件;其中該至少一連接桿(3,3',3")撓性不如該穩定桿之該撓性段(2a);又其中該導件(47a,47b;47a',47b';470a,470b)之直徑,使該連接桿(3)可在其內自由滑動者。
- 如申請專利範圍第1項之穩定裝置,其中該導件設計成一貫穿孔(47a,47b),按平行於該桿軸線之一方向,延伸穿過該側壁(46a,46b)者。
- 如申請專利範圍第1或2項之穩定裝置,其中設有一保固結構(47a,47b;2;471,472),以防該連接桿(3)脫出者。
- 如申請專利範圍第1或2項之穩定裝置,其中該導件係該側壁上之凹部(47a',47b';470a,470b)者。
- 如申請專利範圍第4項之穩定裝置,其中該凹部(47a',47b')係朝該容納件內部開口者。
- 如申請專利範圍第4項之穩定裝置,其中該凹部(470a,470b)係朝該容納件外部開口者。
- 如申請專利範圍第1或2項之穩定裝置,其中該導件設在該側壁之外側,可一體形成於該側壁,亦可為分開導件安裝於該側壁者。
- 如申請專利範圍第1或2項之穩定裝置,其中該導件尺寸比包容一撓性穩定桿用之該開口(45)為小者。
- 如申請專利範圍第1或2項之穩定裝置,其中該固定段(41)係樞動連接於該容納件(43)者。
- 如申請專利範圍第9項之穩定裝置,其中該固定段和該容納件形成一多軸式骨骼螺釘(4,4',400)者。
- 如申請專利範圍第1項之穩定裝置,其中該開口(45)係由該容納件(43)內之一實質上U形凹部所形成,並形成二自由股部,成為該側壁者。
- 如申請專利範圍第1或2項之穩定裝置,其中設有二連接桿(3),可連接於其末端之一者。
- 如申請專利範圍第1或2項之穩定裝置,其中設有至少二骨骼固定裝置,呈多軸式骨骼螺釘之形式,且其中至少一連接桿用於把該多軸式骨骼螺釘之該容納件對齊者。
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2009
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- 2009-09-01 JP JP2009201683A patent/JP5538780B2/ja not_active Expired - Fee Related
- 2009-09-01 CN CN2009101706694A patent/CN101664335B/zh not_active Expired - Fee Related
- 2009-09-01 KR KR1020090082167A patent/KR101563262B1/ko not_active IP Right Cessation
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2015
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Also Published As
Publication number | Publication date |
---|---|
ES2542006T3 (es) | 2015-07-29 |
JP5538780B2 (ja) | 2014-07-02 |
KR101563262B1 (ko) | 2015-10-26 |
US9907578B2 (en) | 2018-03-06 |
CN101664335A (zh) | 2010-03-10 |
JP2010057918A (ja) | 2010-03-18 |
EP2160989A1 (en) | 2010-03-10 |
US20160008035A1 (en) | 2016-01-14 |
KR20100029036A (ko) | 2010-03-15 |
EP2484300A1 (en) | 2012-08-08 |
ES2387512T3 (es) | 2012-09-25 |
US20100094348A1 (en) | 2010-04-15 |
TW201010662A (en) | 2010-03-16 |
US9101403B2 (en) | 2015-08-11 |
EP2484300B1 (en) | 2015-05-20 |
EP2160989B1 (en) | 2012-05-02 |
CN101664335B (zh) | 2012-05-09 |
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