TWI451857B - 把桿件固定於骨骼或椎骨用之固定裝置 - Google Patents

把桿件固定於骨骼或椎骨用之固定裝置 Download PDF

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TWI451857B
TWI451857B TW097147739A TW97147739A TWI451857B TW I451857 B TWI451857 B TW I451857B TW 097147739 A TW097147739 A TW 097147739A TW 97147739 A TW97147739 A TW 97147739A TW I451857 B TWI451857 B TW I451857B
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fixing device
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Lutz Biedermann
Wilfried Matthis
Gerhard Pohl
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Biedermann Technologies Gmbh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037Screws 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/60Surgical 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 for external osteosynthesis, e.g. distractors, contractors
    • A61B2017/603Surgical 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 for external osteosynthesis, e.g. distractors, contractors with three points of contact, e.g. tripod

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Description

把桿件固定於骨骼或椎骨用之固定裝置
本發明係關於一種把桿件固定於骨骼或椎骨用之固定裝置,可用具有不同直徑之至少二桿件。
為穩定脊椎,已知有骨骼固定裝置,包括要固定於骨骼內之軸部,和連接於桿件之頭部。通常,桿件連接若干骨骼固定裝置。視醫療指示和脊椎需要穩定之區域,必須有不同直徑之桿件。桿件直徑範圍從3mm至6mm以上。一般而言,在脊椎下部所用桿件直徑,比在脊椎上部所用桿件直徑大。例如第1圖所示,在脊椎的頸胸椎區101,桿件直徑為3mm至3.5mm,在頸胸椎和胸腰椎間之過渡區102,桿件直徑為3.5mm至4.5mm,在胸腰椎區103,桿件直徑通常為4.5mm至5.5mm,而在腰骶區104,桿件直徑必須為5mm至6.35mm。
對各種直徑的桿件,需要有特殊之骨骼固定裝置,諸如梗節螺釘。尤其是要插入桿件的凹部尺寸彼此不同。提供不同骨骼固定裝置,會提高成本,且使得外科醫師的脊椎手術更為複雜。
US 5,873,878號揭示一種固定構件,可附設於椎骨,並使用具有第一直徑之第一桿件,和較小第二直徑之第二桿件。固定構件包括插入構件,可插入固定構件之頭部內,故容許插入直徑較小的桿件。
本發明之目的,在於提供一種固定裝置,可用具有不同直徑之若干桿件。
此目的是以如申請專利範圍第1項的固定裝置解決。進一步發展列於申請專利範圍附屬項。
固定裝置之優點是,提供安全夾持不同直徑之任何桿件。夾持力不因桿件直徑而定。
此外,骨骼固定裝置之構造,在使組件數減到最少。因此, 不需額外組件,即可固設不同桿件。
固定裝置特別可用於矯正孩童脊柱側彎。孩童成長時,必須採取脊柱側彎矯正裝置。例如,必須使用比原先插入的更大直徑之桿件。本發明骨骼固定裝置可以保留固定在椎骨內之骨骼固定器,在第二次手術中更換原先所用桿件。
本發明其他特點和優點,由如下參照附圖之詳述,即可最為明白。
茲參照第2-4圖說明本發明第一具體例之固定裝置。固定裝置1包括軸部2,一端有尖部3,另一端有頭部4。軸部在其至少一部份包括骨骼螺紋。
頭部4在尖部相反側有凹部5,藉此形成實質上直立延伸二自由股部6,7,界定凹溝,以容納桿件10。在股部6,7設有陰螺紋8,供容納內螺釘9,把桿件10固設於凹溝內。桿件具有圓形或實質上圓形截面。
利用凹部5形成實質上直立之二相對立平坦側壁12,13,詳見第4圖。側壁12,13間之距離,亦即凹部5寬度,比要容納於凹部內的桿件最大直徑稍大,使桿件可以插入,並按桿件軸線方向在其內導引。凹部5之基部11具有實質上V形截面,詳見第4圖。基部11底圓滑。基部11V形之夾角α,使直徑d的桿件10在沿桿件軸線平行方向的二相反對的線接點P1,P2,與基部接觸。
在凹溝中心,設有軸向腔孔14,如第2圖所示,使股部6,7任一側具有凹部5之V形基部11。軸向腔孔14具有內部洞孔,得以達成多點接觸,即左、右接觸。此對預彎和有輪廓的桿件特別重要。股部6,7所設陰螺紋8,從頭部4的自由端延伸跨越預定長度。鄰近陰螺紋8設有底缺15,沿朝向基部11的方向。在第2-4圖所示具體例中,內螺釘為固定螺釘,旋入股部中間。桿件10插入,把固定螺釘9旋入時,一旋緊,即以朝向桿件的下側,壓住桿件。因此,內螺釘9沿接觸線 P3與桿10接觸。
凹部5和V形基部11的寬度W尺寸,以及桿件直徑d和內螺釘9長度,使桿件10可沿三條接觸線P1,P2,P3被夾持。以此方式夾持時,桿件在穩定狀態,與在鎖定段內的三點固設類似。此舉達成沿桿件多線接觸。須知接觸線並非極細線,而是按照接觸有某種厚度的線,由肉眼看得到。此舉提供安全固設,不論桿件直徑如何。
可用於固定裝置的桿件直徑,可在最大直徑和最小直徑之間變化,在幾何形狀上界定,使桿件在任何情況下均與基部11有二線接觸。內螺釘9的長度是,在內螺釘完全旋入時,在觸點P3可碰到桿件。
固定裝置和桿件是由生理相容性材料製成,例如金屬,像鈦,或金屬合金,例如顯示超彈性性質之合金。桿件剛性到旋緊內螺釘時,利用摩擦力即可保持定位。
使用時,至少二固定裝置以其軸部固定於骨骼,例如椎骨之梗節。然後,選用脊椎穩定用桿,具有適於臨床應用之特殊直徑。桿件插入凹部內,旋緊內螺釘加以固設。
參照第5-8圖說明第二具體例。固定裝置20係多軸式骨骼螺釘,包括螺釘元件21,有骨骼螺紋之軸部22,和球形頭部23。球形頭部23在其自由端有凹部24,用來和螺釘工具結合。
固定裝置又包括容納件25,有第一端26,在第一端相反側之第二端27,和中心軸線C。設有腔孔29,與中心軸線C共軸,從第一端延伸到離第二端一段距離。在第二端設有開口,其直徑較腔孔29直徑為小。頭部23樞動保持在容納件內,軸部延伸貫穿開口30。
容納件又有實質上U形凹部31,從第一端起,按第二端方向延伸。利用U形凹部31,形成實質上直立延伸二自由股部32,33。股部設有陰螺紋。
設有加壓元件35,呈實質上圓筒形構造,其外徑只比腔 孔29內徑稍小,使加壓元件可引進入腔孔內,並在其內按軸向運動,在其朝向螺釘元件21頭部23之下側,加壓元件35包括球形凹部,其半徑相當於螺釘元件的球形頭部23半徑。加壓元件相反側包括凹部37,形成二實質上直立延伸股部38,39,有平坦側部38',39'和基部40。基部40呈實質上V形,與第一具體例的基部11類似。基部40側部的夾角α'尺寸,使最大直徑和最小直徑的桿件都可插入,即分別在桿件軸線L平行的二接觸線,與基部40接觸。凹部37深度使直徑在最小和最大之間的所有桿件,其股部38,39均在插入的桿件上表面以上延伸。加壓元件又包括共軸腔孔41,得以藉螺旋工具進出頭部23之凹部24。
為了固設螺釘元件21的桿件10和頭部23,設有固設元件50。固設元件50為二件式固設元件,包括第一外螺釘51,與容納件25的陰螺紋34嚙合,並有第二螺紋腔孔,讓第二內螺釘52插入。第一螺釘51在背離容納件之一端包括環形凸部51a,其結構方便夾住固設元件。第一螺釘51旋緊時,以其下側壓住加壓元件的股部38,39,如第7圖所示,不會碰到插入的桿件。因此,第一螺釘會藉加壓元件35加壓於頭部23,而固設頭部23的樞動位置。
第二螺釘52作用於桿件10。為了能夠能與不同直徑的桿件接觸,第二螺釘在下側包括凸部53,朝向桿件,凸部呈例如圓筒形,其直徑較加壓元件的凹部37寬度小。所以,凸部53碰到桿件,但碰不到加壓元件35。凸部53結構是用來平衡不同的桿直徑。旋緊第二內螺釘52,桿件10即獨立於頭部23固設。
在第6和7圖所示組合和固設狀態,加壓元件的基部40稍微凸出超過容納件的凹部31基部,故桿件10仍置於加壓元件之基部40。
此裝置之使用類似第一具體例,唯一不同的是螺釘元件的樞動位置可利用第一螺釘和加壓元件加以固設。加壓元件的基部,用做桿件底座,有介於最大和最小可能直徑間之所需直徑。
第9a至9c圖簡略表示直徑遞增的桿件10,10',10",10'''之固設。在各情況下,桿件均在二點,或就三維度觀之,是以三接觸線置於基部上。從上面,利用固設元件之內螺釘夾持,以凸部53與桿件接觸。因此,各桿件均在穩定夾持位置,類似三點夾持。此舉可用介於最大和最小可能直徑間的任何直徑之桿件。
第10a至10c圖簡略表示直徑遞增的桿件10,10',10",10'''之固設,與第二具體例不同在於加壓元件和固設元件。加壓元件60有股部61,62,不在插入的桿件上表面以上延伸。固設元件70為單件式固設元件,呈固定螺釘形式,與第二具體例容納件25的陰螺紋34合作。固設元件具有凸部73,作用於桿件。以此具體例,頭部23和桿件10是同時固設。
第11a和11b圖分別表示基部11或40形狀之變化。形成V的側壁,不是平坦,而是彎曲。在第11a圖中,基部有凹曲側壁,在第11b圖中,基部具有凸曲側壁。又,在此變化具體例中,桿件沿二接觸線置於基部上。
上述具體例可有各種修飾例。例如,在桿件置放的基部和桿件插入的凹部側壁之間,有面積可為階梯或傾斜表面。
所示多軸式螺釘呈頂部加載螺釘,即螺釘元件是從容納件第一端或頂部插入,但亦可設計成底部加載螺釘,即螺釘元件可插入於設計成從第二端(即底部)插入之容納件內。
亦可構想把三線固設顛倒,即在固設元件下側形成二線,在基部形成一接觸點或線。亦可將不同具體例之特點加以組合。
101‧‧‧頸胸椎區
102‧‧‧過渡區
103‧‧‧胸腰椎區
104‧‧‧腰骶區
1,20‧‧‧固定裝置
2,22‧‧‧軸部
3‧‧‧尖部
4‧‧‧頭部
5‧‧‧凹部
6,7,32,33,38,39,61,62‧‧‧股部
8,34‧‧‧陰螺紋
9‧‧‧內螺釘
10,10',10",10'''‧‧‧桿件
11,40‧‧‧V形基部
12,13‧‧‧側壁
14‧‧‧軸向腔孔
15‧‧‧底缺
W‧‧‧寬度
α,α'‧‧‧夾角
d‧‧‧直徑
P1,P2,P3‧‧‧接觸線
21‧‧‧螺釘元件
23‧‧‧球形頭部
24‧‧‧凹部
25‧‧‧容納件
26‧‧‧容納件第一端
27‧‧‧容納件第二端
L‧‧‧桿件軸線
C‧‧‧中心軸線
29‧‧‧腔孔
30‧‧‧開口
31‧‧‧U形凹部
35,60‧‧‧加壓元件
37‧‧‧加壓元件凹部
38',39'‧‧‧股部側部
41‧‧‧共軸腔孔
50,70‧‧‧固設元件
51‧‧‧第一外螺釘
52‧‧‧第二內螺釘
51a‧‧‧環形凸部
53,73‧‧‧圓筒形凸部
第1圖為脊椎簡圖,有脊椎穩定裝置,在脊椎不同區域使用不同直徑的桿件;
第2圖為第一具體例固定裝置之透視分解圖;
第3圖為第2圖骨骼固定裝置在組合狀態之透視圖;
第4圖為第3圖固定裝置在組合狀態垂直於桿件軸線之斷面圖;第5圖為第二具體例固定裝置之分解透視圖;第6圖為第5圖固定裝置在組合狀態之透視圖;第7圖為第6圖固定裝置取自垂直於桿件軸線並貫穿固定裝置中心之部份斷面圖;第8a圖為第7圖固定裝置的加壓元件側視圖;第8b圖為第7圖固定裝置的加壓元件取自桿件軸線垂直平面之斷面圖;第8c圖為第7圖固定裝置的加壓元件俯視圖;第8d圖為第7圖固定裝置的加壓元件透視圖;第9a至9d圖簡略表示桿件夾持在第8a至8d圖所示加壓元件中所用桿件有不同直徑;第10a至10d圖簡略表示不同直徑的桿件夾持在修飾具體例之加壓元件內;第11a至11b圖表示桿件底座之修飾具體例。
10,10',10",10'''...桿件
60...加壓元件
61,62...股部
70...固設元件
73...凸部

Claims (11)

  1. 一種把桿件固定於骨骼或椎骨用之固定裝置,可用於不同直徑之至少二桿件:固定裝置(1;20)有軸部(2;22)和頭部(4;25),供連接於該桿件(10)之一;該頭部(4;25)係連接於該軸部(2;22),有凹部(5;31)及基部(11;40),和直立延伸之二股部(6,7;32,33;38,39),界定溝道,把桿件容納於溝道內;以及固設元件(52;70),把該桿件(10)夾持於該溝道內;其中該固設元件和該基部各有接觸表面(11;40;53;73),以接觸該桿件,接觸表面造形是可夾持任何不同之桿件;又其中該接觸表面(11;40;53;73)的造形,使桿件可沿三接觸線(P1;P2;P3)夾持者。
  2. 如申請專利範圍第1項之固定裝置,其中三接觸線之二(P1;P2)位於基部,另一(P3)位於固設元件者。
  3. 如申請專利範圍第1或2項之固定裝置,其中固設元件(52;70)在其朝向桿件之側面具有凸部(53;73),其尺寸得以接觸不同直徑之桿件者。
  4. 如申請專利範圍第1或2項之固定裝置,其中基部(11;40)截面呈V形者。
  5. 如申請專利範圍第4項之固定裝置,其中形成V形狀之基部側壁係彎曲者。
  6. 如申請專利範圍第1或2項之固定裝置,其中頭部(4)和軸部(2)為單軸向連接者。
  7. 如申請專利範圍第1或2項之固定裝置,其中軸部(22)係以樞動方式連接於頭部(25),又其中設有加壓元件(35),鎖定軸部相對於頭部之角度位置,並包括基部(40),供桿件之用者。
  8. 如申請專利範圍第1或2項之固定裝置,其中桿件(10) 具有圓形截面者。
  9. 如申請專利範圍第1或2項之固定裝置,其中固定裝置和桿件係由生理相容性材料製成者。
  10. 如申請專利範圍第1或2項之固定裝置,其中固定裝置和桿件係由生理相容性金屬或合金製成者。
  11. 如申請專利範圍第1或2項之固定裝置,其中基部(11;40)包括內部洞孔(14),分別位於在股部兩側之面積,提供接觸表面者。
TW097147739A 2007-12-13 2008-12-09 把桿件固定於骨骼或椎骨用之固定裝置 TWI451857B (zh)

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US8257399B2 (en) 2012-09-04
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