TWI421063B - 二脊椎骨間插置之隔體 - Google Patents

二脊椎骨間插置之隔體 Download PDF

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Publication number
TWI421063B
TWI421063B TW096124983A TW96124983A TWI421063B TW I421063 B TWI421063 B TW I421063B TW 096124983 A TW096124983 A TW 096124983A TW 96124983 A TW96124983 A TW 96124983A TW I421063 B TWI421063 B TW I421063B
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TW
Taiwan
Prior art keywords
spacer
opening
tubular member
length
wall
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TW096124983A
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English (en)
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TW200803809A (en
Inventor
Lutz Biedermann
Jurgen Harms
Wilfried Matthis
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Biedermann Technologies Gmbh
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Publication of TW200803809A publication Critical patent/TW200803809A/zh
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Publication of TWI421063B publication Critical patent/TWI421063B/zh

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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
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Description

二脊椎骨間插置之隔體
本發明係關於二脊椎骨間插置之隔體。具體而言，本發明係關於調節軸向長度之隔體，在插置於脊椎骨之後，可充填骨骼移殖片。
調節軸向長度之隔體，已見於US 6,200,348號。隔體包括第一套筒形構件，和可在第一構件內滑動導引的第二構件，以調節隔體之總長度。軸向長度的調節，是利用第二構件外壁所設棘輪缺口，以及第一構件所設結合構件為之。隔體在壁上有複數開口，供插置骨骼結合劑，在血管內成長。
通常隔體不是在插置於脊椎骨間之後，經灌注充填骨骼結合劑，便是在移殖入患者身體之前，經管狀隔體開口端充填骨骼材料，尤其是骨骼移殖片。已知隔體在插置於二脊椎骨間之後，可調節隔體的長度。在某些情況下，於調節隔體的軸向長度後，需於隔體內部增減骨骼材料。
US 6,616,695號記載一種在二脊椎骨插置之隔體，其軸向長度可以調節。隔體包括第一管狀組件，具有螺紋內表面，和第二管狀組件，具有螺紋外表面，該二組件形成螺釘/螺帽結合，得以調節隔體之軸向長度。第一管狀組件在壁上具有複數圓孔。第二管狀組件在壁上具有複數長孔。把組件相對轉動，即可調節隔體長度。此舉需要比滑動調節長度更多的空間。此外，在轉動中，脊椎骨本體會受到隔體有齒端板之損傷。長孔供固定螺釘插置。壁上孔太小，無法插置骨骼移殖片。
US 5,290,312號記載一種彌補脊椎骨，可調節軸向長度，包括第一空心平行六面形組件和第二空心平行六面形組件，後者可在第一組件內滑動。各組件有銜接端面，可銜接脊椎骨，並在銜接端形成固定窗口。又，各組件有開口第一側，建立存取窗口，在銜接端相反側形成開口。隔體包括機構，防止組件間滑動，以達成所需長度。為連接隔體和脊椎骨，把柔軟性骨骼結合劑通過存取窗口注入組件內，流出固定窗口外，變硬。由於各組件有開口側，經此側插置的骨骼移殖片容易掉出。再者，開口側導致穩定性降低。
US 6,524,341 B2號亦揭示可調節長度之隔體，必須轉動，使隔體組件彼此相對膨脹和收縮。
US 6,176,881 B1號揭示一種可調節長度之隔體。隔體包括內部空心體和外部空心體，內部空心體在外表面有掣子機制，而外部空心體包含彈性元件扣鎖在掣子機制上，因而固定隔體長度，得以抵抗壓縮。若需堵塞空心體以防膨脹，可用鎖定螺釘，配置在隔體之一側。若隔體長度要再縮短，可用工具作動彈性元件，作用於隔體之相反側。類似US 6,176,881 B1號所揭示之隔體，以商標名Synex上市。此隔體另有凹部開口，供引進骨骼移殖片。
本發明之目的，在於提供一種二脊椎骨間插置之隔體，可調節長度，可在原狀不但充填骨骼材料，還可充填骨骼移殖片，可改進運送。
此目的是以申請專利範圍第1項之隔體解決。進一步發展列於申請專利範圍附屬項。
隔體按習知插置於二脊椎骨間之前，可充填骨骼移殖片。在脊椎骨間插置隔體和調節軸向長度後，即可通過存取開口引進額外骨骼移殖片。另外，在脊椎骨間插置隔體並調節長度後，即可插置全部骨骼移殖片。
此隔體可利用滑動膨脹，滑動所需操作空間和時間，較利用轉動膨脹者為少。
存取開口具有封閉邊緣，造成隔體之機械安定性較具有開口側的存取窗口為高。
長度調節元件和長度固定元件，可從隔體同側存取。此點導致運輸上的改進。此外，存取開口、長度調節元件和長度固定元件可從一側存取，得應用於MIS或MOS。
末段可形成多籠式結構。由於接觸面積較大，且在接觸面積透入骨骼的深度減小，可增進在脊椎骨內之固定，因而減少相鄰脊椎骨之損傷。多籠式結構的外籠輪廓，適合脊椎骨本體的表面輪廓。
隔體可由管製成，較其他形狀在製造上更為簡單。
本發明其他優點由參照附圖之說明，即可瞭解。
由第1至6圖可見，第一具體例之隔體1包括第一圓筒形管狀構件2和第二圓筒形管狀構件3。選擇第二管狀構件3的外徑，使第二管狀構件3可在第一管狀構件2內滑動導引。
第一管狀構件2有第一端4，對立之第二端5，和管壁包圍之空心內部。在離第一端4預定距離之壁上設有存取開口6，延伸跨越第一管狀構件2大約長度之半。在圖示具體例中，存取開口為長方形開口。長方形長側的長度約為第一管狀構件2長度之半，而短側的長度約為第一管狀構件2的四分之一。存取開口6的維度，使自然骨骼移殖片可在手術之際或之後，填入開口內和取出。
同理，第二管狀構件有第一端7，對立的第二端8，管所界定之空心內部和壁。在離第二端一段距離處，於第二管狀構件壁上設有存取開口9。存取開口9延伸跨越第二管狀構件3大約長度之半。在圖示具體例中，存取開口9呈長方形，維度與第一管狀構件的存取開口6相同。在第2圖所示的組合狀態中，第二管狀構件3係插入第一管狀構件2內，使第一管狀構件的存取開口6和第二管狀構件的存取開口9在徑向對準。
由於各管狀構件的存取開口，分別設在離第一端和第二端一段距離處，存取開口乃利用壁的一部份，分別與第一端或第二端分開，所以具有封閉邊緣。
在隔體的縱軸線L方向，第二管狀構件3相對於第一管狀構件2之位置，可藉鎖定結構加以固定。鎖定結構係由在第一管狀構件2壁的軸向對準之複數螺紋孔10所形成。螺紋孔10配置在存取開口6之一側，並封閉存取開口，使螺紋孔可在手術當中，由外科醫師在存取開口的同側存取。又，鎖定結構包括複數截面球形之凹部11，在第二管狀構件3壁的外表面，按隔體的縱軸線L方向配置成一排。凹部11是並列形成，深度較其半徑為小。成排凹部11配置在第二管狀構件3的存取開口9之一側，封閉存取開口9，使在第2和3圖所示組合狀態中，成排的螺紋孔10和成排的凹部11相配。鎖定結構又包括鎖定螺釘12，可旋入螺紋孔10內。鎖定螺釘12一側有截面球形凸部13，可套入截面球形凹部11內。在對立側，鎖定螺釘12有凹部，供螺旋工具結合，成排凹部11延伸至少跨越長度和成排螺紋孔10相同。成排螺紋孔可設有無螺紋孔10a，可供保持工具(圖上未示)結合。
由第2、3和12圖上可見，第一管狀構件2包括長孔15，從離第一端4的一段距離處，延伸到離第二端5的一段距離處。長孔15的長度約與存取開口6長度相同，而寬度遠較存取開口6的寬度為小，使骨骼移殖片不能通過長孔15。此外，第一管狀構件2包括複數菱形開口16，配置在鄰近第二端5之區域內。菱形開口16尺寸比存取開口9的尺寸小，使骨骼移殖片不能通過菱形開口。菱形開口16配置成沿周行列，每一行列與相鄰行列偏離菱形軸向高度之半。最近第二端的成排菱形開口16切開，使開口朝第二端5開啟，形成叉部17，與相鄰脊椎骨結合。
特別在第1和4圖內可見，第一管狀構件2在第一端4開始的區域內，另包括複數圓孔18。圓孔18的尺寸不容骨骼移殖片進出。菱形開口16和圓孔18用來容許血管和組織成長。
同理，第二管狀構件3包括複數圓孔19，鄰接其第二端8，和複數菱形開口鄰接第一端17。圓孔19和菱形開口20尺寸使骨骼移殖片不能通過此等開口進出。類似第一管狀構件2，最近第一管狀構件第二端7之成排菱形開口20切開，形成叉部21，與脊椎骨本體結合。
由第1和4圖可見，設有銷25，可例如固定於第一管狀構件2，並在第二管狀構件3所設長形細縫28(第4圖)內導引，以防轉動，並形成止動部，以防第一和第二管狀構件分離。
隔體又包括第三管狀構件22，其軸向長度約等於菱形開口20位置的第二管狀構件區域之軸向長度。第三管狀構件22在壁上亦包括菱形開口23，以及二自由端之叉部24。第三管狀構件22利用銷26，如第7和8圖示意剖開圖所示，或用螺釘、鉚釘等固定連接於第二管狀構件。第三管狀構件22呈橢圓形截面，如第7圖所示，或是圓形截面，如第8圖所示。第三管狀構件與第二管狀構件末段形成双籠結構，與脊椎骨之接觸面積，較唯有第二管狀構件的接觸面積有所增進。由於第二管狀構件的外徑較第一管狀構件為小，第三管狀構件可用來擴大接觸面積，使叉部之環形，適應所要結合的脊椎骨本體之末端表面輪廓。
由第1至6圖可見，與第三管狀構件22類似的第四管狀構件27，設在第一管狀構件2的第二自由端5內側，並附在第一管狀構件2內，形成双籠結構。第四管狀構件27亦包括菱形開口和叉部，供結合於骨骼。
在組合狀態時，長孔15覆蓋第二管狀構件3之至少一圓孔19或菱形開口20。第一管狀構件之長孔和第二管狀構件的圓孔或菱形開口之一，形成長度調節結構之一例，與工具結合時，容許二管狀構件彼此相對伸縮。
在圖示具體例中，存取開口、鎖定結構和長度調節結構，在隔體沿周約一半或以下範圍內，配置成組合狀態。
第12和13圖表示第二管狀構件3相對於第一管狀構件2伸縮用之長度調節工具。工具30包括管31，一端有柄32，另一端為叉形段33。轉動軸線34跨越自由端之叉形段。剪刀狀結構35與叉形段33樞動連接。剪刀狀結構35可繞軸線34樞動。包括臂桿35a和35b，可在摺疊位置和展開位置之間運動。臂桿之一構成與第一管狀構件2的長孔15結合，另一臂構成與第二管狀構件3的圓孔或菱形開口之一結合。
工具又包括桿，自由端有柄37。桿容納於管31內，伸入叉形段33。用柄37轉動桿，即運動剪刀狀結構35，分別使臂桿35a和35b開闔。
使用上，隔體在插置於脊椎骨間之前，充填骨骼移殖片。隔體具有最低長度。然後，把隔體插置於二相鄰脊椎骨之間，例如在除去脊椎骨後，跨越間隔。再從第一管狀構件伸縮第二管狀構件，調節隔體長度。運動是滑動，而不轉動。第12和13圖所示工具使用方式是，剪刀狀結構以一臂淦35a插置於第一管狀構件之長孔15內，另一臂桿35b結合於第二管狀構件之孔19或20。轉動桿，剪刀狀結構即軸動，而第二管狀構件從第一管狀構件伸縮。達成所需長度時，鎖定螺釘12即插置入螺紋孔10內，直到截面球形之凸部與截面球形凹部18結合為止。由於第一管狀構件和第二管狀構件之存取孔分別對準，隔體有開孔大到足夠插置骨骼移殖片。再將其他骨骼移殖片插置，完全填滿隔體的內部。
由於鎖定結構和用於伸縮的長孔15位在同側，隔體可快速調節至其所需軸向長度，並固定於此位置。由於第一和第二管狀構件的存取開口是在接近鎖定結構之同側，可在手術當中快速充填於骨骼移殖片內。
隔體可經被覆，以增進血管或組織的成長。隔體可分別在管狀構件的外表面和內表面被覆不同材料，第一和第二管狀構件可被覆不同材料。
圖示具體例可加以修改。存取開口不需為長方形，可為任何形狀，惟要大到足夠容許插置骨骼移殖片。可設有一以上之長孔15。
圓孔和菱形開口可以省略，或呈任何其他形狀，惟要小到不容骨骼移殖片除去或插入。在此情況下，與工具結合用之第二管狀構件上的開口，可改在第二管狀構件上設有另一表面結構。
鎖定結構亦可加以修改。球形凹部11可設在第一管狀構件內壁，而螺紋孔可設在第二管狀構件壁上。鎖定螺釘再從空心內部旋入螺紋孔內。
圖示管狀構件呈圓形截面。然而，任何其他形狀之截面均可用。例如，管狀構件的截面形狀可適合脊椎骨本體端面之輪廓。
第三管狀構件和第四管狀構件亦可為不同於圓形截面或橢圓形截面之截面形狀。
其他管狀構件可附設在第一和/或第二管狀構件之末端段，提供多籠式結構。另外，第三和第四管狀構件可以省略。
1．．．隔體
2．．．第一圓筒形管狀構件
3．．．第二圓筒形管狀構件
4．．．第一構件的第一端
5．．．第一構件的第二端
6．．．第一構件存取開口
7．．．第二構件的第一端
8．．．第二構件的第二端
9．．．第二構件存取開口
10．．．螺紋孔
10a．．．無螺紋孔
11．．．球形凹部
12．．．鎖定螺釘
13．．．球形凸部
15．．．長孔
16,20,23．．．菱形開口
17,21,24．．．叉部
18,19．．．圓孔
22．．．第三管狀構件
25,26．．．銷
28．．．長形細縫
27．．．第四管狀結構
L．．．縱軸線
30．．．長度調節工具
31．．．管
32,37．．．柄
33．．．叉形段
34．．．轉動軸線
35．．．剪刀狀結構
35a,35b．．．臂桿
第1圖為隔體具體例之透視分解圖；第2圖為隔體在軸向長度接近可能最小長度的組合狀態之側面透視圖；第3圖為隔體在長度大於第2圖所示的組合延伸狀態之側面透視圖；第4圖為第2圖所示隔體之側視圖；第5圖為第2圖所示隔體之俯視圖；第6圖為第2圖所示隔體之仰視圖；第7圖為第一具體例隔體末端段俯視之示意分解圖；第8圖為第二具體例隔體末端段俯視之示意分解圖；第9圖為鎖定元件之透視圖；第10圖為第9圖鎖定元件之側視圖；第11圖為隔體軸向長度固定用之鎖定結構斷面圖；第12圖為隔體與長度調節機構結合之側面透視圖；第13圖為長度調節工具之透視圖。
1．．．隔體
2．．．第一圓筒形管狀構件
3．．．第二圓筒形管狀構件
4．．．第一構件的第一端
5．．．第一構件的第二端
6．．．第一構件存取開口
7．．．第二構件的第一端
8．．．第二構件的第二端
9．．．第二構件存取開口
10．．．螺紋孔
10a．．．無螺紋孔
11．．．球形凹部
12．．．鎖定螺釘
16,20,23．．．菱形開口
17,21,24．．．叉部
18,19．．．圓孔
22．．．第三管狀構件
25．．．銷
L．．．縱軸線

Claims (11)

  1. 一種二脊椎骨間插置之隔體，該隔體具有可變化軸向長度，包括：一第一構件(2)，有一空心內部和一管狀壁；和一第二構件(3)，有一空心內部和一管狀壁，該第二構件可在該第一構件內按軸向滑動，供調節總長度，其中該第一構件(2)或該第二構件(3)至少其一，包括在其壁上之一存取開口(6,9)，其尺寸適於供骨骼移殖片插置貫穿開口進入內部；一長度調節結構(15,19,20)可與一工具(30)結合，供該第二構件(3)相對於該第一構件(2)伸縮；以及一鎖定結構(10,11,12)，供固定軸向長度；其中該存取開口、該長度調節結構和該鎖定結構之配置，可從該隔體同側存取；其中該長度調節結構(15,19,20)包括一長孔(15)，在該第一構件(2)壁上按軸向延伸，和一結構(19,20)在該第二構件(3)壁上，可與該工具結合者。
  2. 如申請專利範圍第1項之隔體，其中該第一構件(2)和該第二構件(3)各包括一存取開口者。
  3. 如申請專利範圍第2項之隔體，其中該第一構件之該開口(6)，和該第二構件之該開口(9)，彼此至少部份重搭者。
  4. 如申請專利範圍第1至3項任一項之隔體，其中該開口(6,9)尺寸容許骨骼移殖片在體內插置者。
  5. 如申請專利範圍第1至3項任一項之隔體，其中該開口(6,9)具有一封閉邊緣者。
  6. 如申請專利範圍第1至3項任一項之隔體，其中該鎖定結構(10,11,12)包括複數凹部(11)，在該第一構件或該第二構件壁上按軸向配置成一行，而分別在其餘之該構件，設有一結合構件(12)與該凹部至少其一結合者。
  7. 如申請專利範圍第6項之隔體，其中該凹部(11)配置在該第二構件(3)外表面，而該結合構件(12)包括一凸部(13)，從該第一構件(2)內表面突出者。
  8. 如申請專利範圍第1至3項任一項之隔體，其中該結構(19,20)包括一洞孔，與該長孔重搭者。
  9. 如申請專利範圍第1至3項任一項之隔體，其中該第一構件或該第二構件至少其一包括壁上複數第二孔(16,18,19,20)，比該存取開口為小，不容骨骼移殖片引入者。
  10. 如申請專利範圍第1至3項任一項之隔體，其中該第一構件或該第二構件至少其一在其自由端包括一第一圈叉部(17,24)，在該第一圈叉部內有至少一第二圈叉部(24)，供固定於脊椎骨本體內者。
  11. 如申請專利範圍第1至3項任一項之隔體，其中該長孔(15)之寬度比該存取開口(6,9)之寬度小，使骨骼移殖片不能穿過該長孔(15)者。
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