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TWI391121B - 骨骼固定裝置 - Google Patents

骨骼固定裝置 Download PDF

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TWI391121B
TWI391121B TW095124725A TW95124725A TWI391121B TW I391121 B TWI391121 B TW I391121B TW 095124725 A TW095124725 A TW 095124725A TW 95124725 A TW95124725 A TW 95124725A TW I391121 B TWI391121 B TW I391121B
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rod
pressing member
recess
bone fixation
fixation device
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TW095124725A
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TW200706156A (en
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Wilfried Matthis
Lutz Biedermann
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Biedermann Technologies Gmbh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. stabilisers comprising fluid filler in an implant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. 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
    • A61B17/7037—Screws 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

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Description

骨骼固定裝置
本發明係關於一種骨骼固定裝置，包括固定元件，有要固定於骨骼之幹部，和頭部；接納部，接納該頭部，與桿連接；施壓元件，對該頭部施壓；以及各種封閉元件，與該接納部合作，把桿穩固於接納部內。
US 5,443,467號揭載一種骨釘，包括具有螺紋部的接納構件和螺釘構件，以及頭部。施壓圓盤，可在接納構件內滑動，並作用於頭部。桿置於施壓圓盤頂部，此配置利用桿鎖定螺帽加以鎖定，而鎖定螺帽對桿施壓力，則施壓於施壓圓盤，因而將頭部鎖定。
US 6,063,090號揭載一種脊柱固定系統，連帶有梗螺釘和扣持頭部，把有梗螺釘與縱向支持件加以連接。設有插件12，對容納在扣持頭部內之有梗螺釘的頭部施壓。設有拉力機構，對插件加壓，把有梗螺釘的頭部鎖定在多軸向位置，將縱向支持件固定。視插件和拉力機構，桿和骨釘頭部可分別牢固。
US 2003/0100896 A1揭載一種元件，有幹部和相連接之保持元件，可供連接於桿，其中保持元件有凹部，呈U形斷面，供接納桿，有二開口股部，開口股部有陰螺紋，而固定元件有陽螺紋，與股部之陰螺紋合作。在一具體例中，保持元件與骨釘的頭部呈多軸向連接。為將頭部鎖定於多軸線向位置，設有施壓圓盤，當利用內螺釘對桿施壓時，即對頭部作動。在另一具體例中，可獨立於桿的固定，把頭部鎖定。若在手術當中同時使用二種固定裝置，則必須有不同種類的固定裝置分別存貨，或是在手術之前或之際，將較佳固定裝置與所需施壓圓盤和/或施壓元件預先組裝。
US 2004/018647381號揭載一種骨骼固定裝置，有骨骼固定元件，係多軸向連接於接納部，並有施壓元件對頭部施壓，把頭部鎖定於其定位，其中設有內螺釘，可螺入接納部，對桿施壓。桿插入時，陰螺紋到桿上方為止，並具有底缺，使接納部的設計在維度上較小。
本發明之目的，在於提供改進之骨骼固定裝置，用途多樣，尺寸精巧。
此目的是以如申請專利範圍第1或12項之骨骼固定裝置解決。進一步發展載於申請專利範圍附屬項內。
本發明骨骼固定元件的優點是，可以兩種方式選擇封閉元件使用。若選用單件式封閉元件，可同時把頭部固定於多軸向位置，並把桿固定。若選用二件式封閉元件，則可分別鎖定頭部，並把桿固定。對二種應用，都只需單一接納部和施壓元件。所以，外科醫師可使用一骨骼固定裝置，並在手術之際選擇使用何種封閉機制。
骨骼固定裝置尺寸精巧，因為不必使用外螺帽或環，預防股部張開。又，接納部的壁厚使得不會有像螺紋般外延或底缺等變薄的內部，致使結構減弱。
本發明其他特點和優點，由具體例之說明連同附圖，即可明白。
如第1至3圖所示，骨骼固定裝置之第一具體例，包含骨釘1，有設骨骼螺紋之幹部2，和球形截頭3，設凹部4，可供旋入工具結合。骨骼固定裝置又包括接納部5，呈實質上圓筒形，有第一端6，和與第一端對立之第二端7。二端係垂直於縱軸線8，設有第一腔孔9與縱軸線8共軸，從第一端6延伸至離第二端7預定距離處。在第二端7設有開口10，其直徑較腔孔9直徑為小。共軸腔孔9朝開口斜縮。在圖示具體例中，呈球形段11形式斜縮。共軸腔孔9的直徑在圖示具體例中較頭部3的最大直徑還要大，故骨釘1可引導通過腔孔9，以幹部2延伸貫穿開口10，而頭部3即置於緊靠球形段11。
接納度5又有U形凹部12，在第一端6開始，朝第二端7方向延伸，使U形凹部之底部13與第二端7有一段距離d。U形凹部12在側向垂直於縱軸線8的寬度，比U形凹部內所接納的桿14之直徑稍大。利用U形凹部12，形成二自由股部15,16，尾端朝向第一端6。鄰接第一端6，接納部包括在股部15,16之陰螺紋17。特別由第2圖可見，設有第二共軸腔孔18，鄰接第一端6，其直徑比第一共軸腔孔9直徑大，故在第一腔孔9至第二腔孔18之過渡處形成肩部9a。共軸腔孔18的內徑和陰螺紋17對立螺峰間之內徑，實質上相同。螺紋17開口進入U形凹部12。所以，無螺紋伸，亦無底缺。在組合狀態，桿14插入接納部5內時，陰螺紋17到該股部15,16的位置為止，是在桿14的上表面以上。
又，設有施壓元件20，呈實質上圓筒形構造，有第一端21和與第一端對立之第二端22。外徑只比第一共軸腔孔9的內徑稍小，使施壓元件可引進入接納部5的腔孔9內，並在軸向移動。施壓元件20包括球形凹部23，鄰接第二端而在組合狀態面朝頭部，其半徑相當於球形頭部3之半徑。施壓元件在鄰接其第一端21具有U形凹部24，橫越縱軸線8延伸。選擇比U形凹部24之側向直徑，使要接納於接納部5內之桿14，可插入凹部24內，並在其內側向導引。利用U形凹部24，形成施壓元件20之開口股部25,26，尾端朝第一端21。按接納部5的縱軸線8方向看，U形凹部，比要接納的桿14之直徑大，使得桿置於U形凹部24的底部27時，股部25,26突出於桿上方。
施壓元件20又包括共軸腔孔28，得以藉螺絲起子存取骨釘1。
特別由第1和2圖可見，施壓元件20包括在該股部25,26之沿周凸部29，鄰接第一端21，其外徑比接納部5的第二共軸腔孔18之內徑為小，其方式為施壓元件20可連同沿周凸部29在第二共軸腔孔18內滑動。
骨骼固定裝置又包括封閉元件，在此具體例內為單件式封閉元件，呈內螺釘30形式。內螺釘30之陽螺紋與股部15,16所設陰螺紋17合作。在陰螺紋30之一端有凹部31，與旋入工具結合。內螺釘的相反端有第一圓筒形凸部32，其直徑是在內螺釘30旋入股部25,26之間時，使圓筒形凸部32正好可沿第二共軸腔孔18內壁滑動。第一圓筒形凸部32斜縮進入第二圓筒形凸部33，直徑比桿的直徑大，但比第二腔孔18的直徑小，在第2圖的組合狀態，與鄰接施壓元件20第一端的相對應圓形凹部34結合。第二凸部33的自由端表面平坦。
施壓元件20相對於骨釘頭部3和接納部5之維度是，在骨釘尚未鎖定在相對於接納部5的最後多軸向位置之狀態時，施壓元件20的U形凹部24之底部27，與接納部第二端7之距離，比第1圖所示距離d大，故突出於接納部5的U形凹部12之底部13上方，如第3圖所示。在此狀態，施壓元件20在第一共軸腔孔9內滑動，而凸部21在第二共軸腔孔18內滑動，其方式是凸部21不置於肩部9a。內螺釘30在軸向之維度是，在內螺釘30尚未旋緊時，圓筒形凸部33不會觸及桿14的表面。
內螺釘30的維度是，使得在最後旋緊狀態時，內螺釘30不會對施壓元件20旋壓，即圓筒形凸部33的長度使內螺釘的第一圓筒形凸部32表面，和施壓元件第一端21之間，形成間隙35。接納部的陰螺紋17和內螺釘30的螺紋，最好是平板螺紋，以防股部張開。
使用時，先把骨釘1引進接納部5內，幹部2引導通過開口10，直至頭部3置於緊靠球形段11或開口10形成之邊緣。然後，把施壓元件20引進入接納部，使球形凹部23包圍骨釘的頭部3上段。在此狀態，施壓元件U形部的底部27，突出於接納部5 U形凹部之底部13上方。此時，骨釘的頭部樞動保持於接納部之球形段11，如同球窩接合。其次，把骨釘螺合骨骼內。接納部5、骨釘1和施壓元件20可預組合，具有機構(圖上未示)預防施壓元件20脫出接納部5。
然後，把桿14插入接納部，使其置於施壓元件20的底部27。由於骨釘和接納部間之多軸向連接，接納部可對準，有相對於桿之正確導向。然後，內螺釘30即旋入股部15,16間，直至圓筒形凸部33的下表面，與桿14之上表面接觸。接納部5第二共軸腔孔18之內壁，可做為內螺釘圓筒形凸部之導引表面，在內螺釘30旋入之時，可防止內螺釘傾斜。
同時，第二共軸腔孔18和肩部9a可供施壓元件20相對於接納部5對準。同理，施壓元件20的圓形凹部34形成內螺釘30圓筒形凸部33之導引表面。
如第7a圖所示，在內螺釘30最後旋緊時，內螺釘30的下表面壓住桿，桿壓到施壓元件20。因為圓筒形凸部33下側和施壓元件第一端21間之間隙，只對桿施壓，桿本身則經由施壓元件20對頭部施壓。因此，頭部和桿同時固定。
接納部的設計精巧，因為不必要外安全環或螺帽。由於陰螺紋17不會有螺紋外延，且接納部5的內部亦不構成底缺，故股部15,16堅硬，因為朝接納部5的內側增進厚度。如此一來，在內螺釘旋入時，可減少股部張開。又，有股部突出於桿上方之施壓元件，容易在接納部內對準。
本發明第二具體例如第4、5和7b圖所示。第4和5圖所示骨骼裝置，與第1至3圖和第7b圖所示骨骼固定元件不同，在於所用封閉元件。其他所有元件一致，以同樣參考符號標示，不再贅述。
第4和5圖所示具體例一部份之封閉元件，係二件式封閉元件，包含螺帽40，可旋入於接納部5的股部15,16之間。螺帽40有陽螺紋，與股部之陰螺紋17合作。此螺紋可為平板螺紋，以防股部張開。螺帽40又設有陰螺紋42。一端設有細縫43，可與螺絲起子結合。在面朝接阿部5側，螺帽40有環形凸部44，外徑比第二共軸腔孔18之內徑稍小。
封閉元件又包括內螺釘或固定螺釘45，其陽螺紋與螺帽40的陰螺紋合作。螺紋可為公制螺紋。內螺釘有凹部46，可與旋入工具結合。螺帽40的維度使得在第4圖所示完全旋緊狀態時，環形凸部44壓到施壓元件20之第一端21。內螺釘45的維度，使得在完全旋緊狀態時，對桿施壓。
使用時，一如第一具體例，先將螺釘元件引進入接納部。再插入施壓元件20，並先寬鬆保持於接納部內。施壓元件容易對準，因為第一共軸腔孔9和第二共軸腔孔18之故。接著，把骨釘螺入骨骼內，桿14插入接納部之U形凹部12內，後者與施壓元件之U形凹部24對準。在桿置入時，施壓元件之定位，使其U形凹部的底部27突出於接納部5的U形凹部之底部13上方。螺釘元件、接納部和施壓元件，亦可預先組合。
基於此，把螺帽40旋入，內螺釘45寬鬆螺入，直至螺帽40毗連於施壓元件的股部25,26之上端，對施壓元件施以向下力量，即壓到螺釘頭部3，把螺釘鎖定在接納部5內之最後多軸向位置。此時，桿14仍可在施壓元件20的U形凹部內滑動，因為施壓元件20的股部25,26突出於桿上方。此外，桿14利用螺帽40防止脫落或傾斜。最後，把內螺釘45旋緊，直至壓到桿14，加以固定。桿之固定不與頭部之固定單獨進行，如第7b圖所示。
一如第一具體例，骨骼固定裝置精巧，因為不需外安全元件。再者，方便施壓元件之對準。
如第6圖所示，於手術當中，外科醫師可選用單件式封閉元件30或二件式封閉元件40,45，可與同樣骨骼固定裝置共用。對於某些用途，以同時鎖定頭部和固定桿之單件式封閉元件為優，尤其是進行快速固定。對其他某些用途而言，其優點是把頭部和桿分別固定。由於外科醫師可用同樣骨骼固定裝置，並自由選用所需封閉元件，不必有不同的接納部，連帶不同的施壓元件或不同的骨骼固定裝置。
具體例可以修改。平板螺紋可以改用其他螺紋形式。此舉需要附加外安裝元件，諸如環或螺帽，與股部的陽螺紋合作，亦可構想省略陰螺紋，並使用帽蓋連同安全銷，壓在桿上。此時，銷的形狀應當在觸及桿時，不會壓到施壓元件之第一端21。
頭部3置靠的接納部段11，不需球形，可有任何其他形狀，只要頭部3利用開口10邊緣把持即可，一如球窩結合樣。
還可以有進一步修改。在第二具體例內，螺帽40在面背圓筒形凸部44之末端，可有額外帽蓋部，以免股部張開之虞。此外，亦可構想類似第一具體例之修改。在進一步修改中，頭部是從接納部的底部引進，那是第二端。
1．．．骨釘
2．．．骨釘幹部
3．．．球形截頭
4,31．．．凹部
5．．．接納部
6,21．．．第一端
7,22．．．第二端
8．．．縱軸線
9．．．第一共軸腔孔
9a．．．肩部
10．．．開口
d．．．底部與第二段之距離
11．．．球形段
12,24．．．U形凹部
13,27．．．U形凹部之底部
14．．．桿
15,16．．．股部
17,42．．．陰螺紋
18．．．第二共軸腔孔
20．．．施壓元件
23．．．球形凹部
25,26．．．開口股部
28．．．共軸腔孔
29．．．沿周凸部
30．．．內螺釘
32．．．第一圓筒形凸部
33．．．第二圓筒形凸部
34．．．圓形凹部
35．．．間隙
40．．．螺帽
43．．．末端開縫
44．．．環形凸部
45．．．固定螺釘
46．．．內螺釘凹部
第1圖表示具有單件式封閉元件的骨骼固定元件之分解透視圖；第2圖表示第1圖骨骼固定元件之斷面圖；第3圖表示第1圖骨骼固定元件之透視圖；第4圖表示具有二件式封閉元件的骨骼固定元件之斷面圖；第5圖表示第4圖骨骼固定元件之透視圖；第6圖表示具有單件式封閉元件和二件式封閉元件的骨骼固定裝置之使用可能性；第7a圖表示具有單件式封閉元件的骨骼固定裝置之鎖定機制簡圖；第7b圖表示二件式封閉元件之鎖定機制簡圖。
2．．．骨釘幹部
5．．．接納部
13．．．U形凹部之底部
14．．．桿
17．．．陰螺紋
20．．．施壓元件
24．．．U形凹部
30．．．內螺釘
32．．．第一圓筒形凸部
33．．．第二圓筒形凸部
40．．．螺帽
43．．．末端開縫
44．．．環形凸部
45．．．固定螺釘

Claims (13)

  1. 一種骨骼固定裝置，包括：固定元件(1)，包括要固定於骨骼或脊椎之幹部(2)，和頭部(3)；接納部(5)，包括第一端(6)，和與第一端對立之第二端(7)，通過二端之縱軸線(8)，與縱軸線共軸之腔孔(9)，鄰接第二端(7)以接納該頭部之第一區(11)，以及凹部(12)，朝第一端(6)開口，形成二自由股部(15,16)，以接納桿(14)；施壓元件(20)，對該頭部(3)施壓，把該頭部鎖定於接納部(5)內；以及第一封閉元件(30)，與該股部(15,16)合作，把該桿穩固於接納部(5)之該凹部(12)內，第一封閉元件(30)作用於桿，同時把頭部和桿固定；第二封閉元件(40,45)，與股部(15,16)合作，把桿穩固於接納部(5)之該凹部(12)內，第二封閉元件作用於施壓元件和桿，把頭部和桿單獨固定；其中第一封閉元件和第二封閉元件可交互使用者。
  2. 如申請專利範圍第1項之骨骼固定裝置，其中在該股部(15,16)設有陰螺紋(17)，而該第一封閉元件即為內螺釘(30)，可旋入該股部(15,16)之間，只對該桿(14)施以壓力者。
  3. 如申請專利範圍第1或2項之骨骼固定裝置，其中該第一封閉元件(30)包括中央凸部(32,33)，作用於該桿(14)，選擇中央凸部之長度，使得在桿固定時，施壓元件(20)和封閉元件(30)之間留有間隙(35)者。
  4. 如申請專利範圍第3項之骨骼固定裝置，其中該施壓元件(20)具有第一端(21)，與施壓元件(20)的第一端(21)對立之第二端(22)以及凹部(24)，朝向施壓元件 (20)的第一端(21)開口以接納桿，施壓元件(20)的凹部(24)深度比桿直徑大，該凸部(32,33)的長度和桿(14)的直徑之和，比施壓元件(20)從施壓元件(20)之凹部(24)的底部(27)至其第一端(21)之高度為大者。
  5. 如申請專利範圍第1項之骨骼固定裝置，其中在該股部(15,16)設有陰螺紋(17)，而該第二封閉元件包括螺帽(40)，有陽螺紋與陰螺紋嚙合，以及內螺釘(45)，要旋入螺帽(40)內者。
  6. 如申請專利範圍第5項之骨骼固定裝置，其中在鎖定狀態，螺帽(40)壓在施壓元件(20)，把該頭部(3)鎖定，而該內螺釘(45)壓在該桿(14)上，將該桿固定者。
  7. 如申請專利範圍第1項之骨骼固定裝置，其中在該股部(15,16)設有陰螺紋(17)，在桿插入時，陰螺紋到該桿(14)上方為止，又其中鄰接陰螺紋(17)設有導引表面(18)，以導引封閉元件插入者。
  8. 如申請專利範圍第1項之骨骼固定裝置，其中在該股部(15,16)設有陰螺紋(17)，接納部(5)之最大內徑，不大於該陰螺紋對立螺峰間之直徑者。
  9. 如申請專利範圍第1項之骨骼固定裝置，其中在接納部(5)內之該凹部實質上呈U形者。
  10. 如申請專利範圍第10項之骨骼固定裝置，其中該施壓元件(20)有第一端(21)，與施壓元件(20)的第一端(21)對立之第二端(22)，以及凹部(24)，朝向施壓元件(20)的第一端(21)開口以接納桿，施壓元件(20)的凹部(24)深度比桿直徑大，該施壓元件(20)之該凹部(24)實質上呈U形者。
  11. 如申請專利範圍第1項之骨骼固定裝置，其中在該股部(15,16)設有陰螺紋(17)，該股部開口通入接納部(5)之凹部(12)者。
  12. 如申請專利範圍第1項之骨骼固定裝置，其中該施壓元件(20)具有第一端(21)，與施壓元件(20)的第一端(21)對立之第二端(22)，以及凹部(24)，朝施壓元件(20)的第一端(21)開口以接納桿，凹部(24)之深度比桿之直徑為大者。
  13. 如申請專利範圍第12項之骨骼固定裝置，其中在預組合狀態時，施壓元件(20)的凹部(24)之底部(27)，按接納部(5)的第一端(6)之方向，突出於接納部的凹部(12)之底部(13)上方者。
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US9333010B2 (en) 2016-05-10
US7955359B2 (en) 2011-06-07
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US20110208249A1 (en) 2011-08-25
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