TWI533837B - 骨骼固定件及骨骼固定總成 - Google Patents

骨骼固定件及骨骼固定總成 Download PDF

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TWI533837B
TWI533837B TW098121485A TW98121485A TWI533837B TW I533837 B TWI533837 B TW I533837B TW 098121485 A TW098121485 A TW 098121485A TW 98121485 A TW98121485 A TW 98121485A TW I533837 B TWI533837 B TW I533837B
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bone
stem
plug member
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陸茲 畢德曼
威爾弗瑞德 馬希斯
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畢德曼科技股份有限公司
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    • 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
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Description

骨骼固定件及骨骼固定總成
本發明係關於骨骼固定件，具有套管幹部，和栓塞構件，可***幹部內，把幹部一端封閉。本發明又關於一種工具，供引進栓塞構件。骨骼固定件特別適用於最少侵襲性手術(MIS)。
WO 01/26568 A1記載一種骨骼固定件，形成骨骼螺釘，有釘頭和螺紋幹部，包括軸向徑孔，和複數徑向徑孔。軸向徑孔在螺釘頭側開口，在螺釘幹部自由端封閉。已知骨骼螺釘可藉骨水泥射入幹部內，而固定於骨骼內。此舉導至骨骼固定件之永久安全固設。
US 5,047,030號亦揭示一種骨骼固定件，形成骨骼螺釘，有套管幹部。骨骼螺釘內含連續性縱溝，有若干徑向延伸橫溝，與縱溝接觸。縱溝在螺釘兩端開啟。可連接真空泵，經由螺釘頭周圍之管，供應真空、抽血和其他物質。
WO 02/38054 A2、US 2004/0122431 A1和US 2004/0147929 A1記載一種骨骼螺釘，有管狀螺紋部，和尖端部，可連接於管狀螺紋部。管狀螺紋部壁上有許多凹部。可用骨水泥充填於管狀螺紋部。
施行最少侵襲性手術的情況日增。在某些情況下，最少侵襲性手術使用導線把植入體置入植入處。最少侵襲性存取常經由皮膚為之。
本發明之目的，在於提供骨骼固定件，有廣泛的應用範圍，例如適於以最少侵襲性手術置於植入處，並可充填骨水泥或另一物質。
此目的是以申請專利範圍第1項之骨骼固定件，和申請專利範圍第12項之工具解決。進一步發展則列入申請專利範圍附屬項內。
本發明骨骼固定件的優點是，可兼用於習用手術和最少侵襲性手術。可對現有套管式骨骼螺釘提供栓塞構件，使其適合於最少侵襲性手術。
具有栓塞構件之骨骼螺釘，防止射入的骨水泥在骨骼固定件尖端漏出。此舉減少血管結構可能損害。
其他特點和優點由參照附圖說明本發明具體例即可明白。
第1-8圖表示本發明骨骼固定件之第一具體例。骨骼固定裝置1包括骨骼固定件2，供固定於骨骼內；容納件3，供容納桿件4；壓力元件5，作用於骨骼固定件2；和保固元件6。所述具體例之骨骼固定裝置1，設計成所謂多軸式骨骼螺釘，其特徵為，骨骼固定件2可樞動保持於容納件3內，把骨骼固定件聯結於脊柱桿件4。骨骼固定件相對於桿件之角度位置，利用保固元件6固設。
特別如第3圖所示，骨骼固定件2包括幹部7，第一端有頭部8，自由第二端9形成尖端。在圖示具體例中，頭部8形成球形截面。又，在幹部7外表面的至少一部份，設有骨骼螺紋10。
骨骼固定件2有套管。包括實質上共軸徑孔11，從第一端貫穿頭部8和幹部7，直到第二端9。在鄰接第二端9之一部份，徑孔直徑比幹部7主要部份小，因而在幹部7內側產生肩部13。在頭部8的自由端設有結合結構14，可與工具結合。在幹部7壁上設有複數開口15，連接徑孔11與外側。開口15數量、大小和配置，按照骨骼固定件2的整體維度設計，目的在於形成骨水泥或藥劑物質可引進入骨骼固定件2之出口。
徑孔11尤其是末端部12之直徑，設計成最少侵襲性手術常用的導線，可導經骨骼固定件2。
容納件3詳如第1-3圖所示，係實質上圓筒形，有第一 端3a和對立之第二端3b。容納件3包括共軸徑孔16，從第一端朝第二端方向延伸，並朝第二端斜縮，故骨骼固定件之頭部8樞動保持於容納件3內。再者，容納件具有實質上U形凹部17，從第一端3a開始，延伸入第二端3b方向，藉此形成二自由股部18a,18b。該自由股部18a,18b一部份設有陰螺紋19，供旋入保固元件6。在此具體例內，保固元件6係內螺釘。
壓力元件5用來施壓於骨骼固定件的頭部8，在內螺釘旋緊時，即壓緊桿件4。壓力元件5之設計是，可引進入共軸徑孔16內，並在其內按軸向運動。在其朝頭部8之側面，包括實質上球形凹部20，以便把壓力分佈於頭部8，在其對立側，有實質上圓筒形凹部21，容納桿件4。亦包括共軸徑孔22，把導線或螺絲工具導引通過。
如第4-8圖所示，骨骼固定件又包括栓塞構件30，在自由第二端9的末端部12，封閉幹部7的徑孔11。栓塞構件30是分開組件，可引進入徑孔11內。在第4-8圖所示具體例中，栓塞構件30包括第一圓筒部31，其直徑可套入幹部7之末端部12內。在第一圓筒部31的自由端，可設切角部32，以方便引進栓塞構件。栓塞構件在切角部32對面，包括第二圓筒部33，其直徑是可套合徑孔11的內徑。第一圓筒部31和第二圓筒部33間設有過渡部34，其形狀配合徑孔11主部和縮徑末端部12間之肩部13形狀。因此，肩部13形成引進栓塞構件之止動部。
在第二圓筒部33的自由端，設有複數直立保持彈簧35。保持彈簧35配置成圓形，直徑較第二圓筒部33小，具有彈性，以便朝外和/或朝內彈性活動。在其自由端，保持彈簧35分別包括掣子36，可與工具脫卸結合，詳後。保持彈簧35的配置方式，使掣子36外部不會突出到第二圓筒部33直徑外。
如第8圖所示，栓塞構件30完全***徑孔11內時，在 第二部封閉徑孔，使引進徑孔11內的骨水泥或藥劑物質，不會經第二端9逸出。
製作骨骼固定件、容納件、壓力元件和保固螺釘的材料，可為此等裝置能用的任何材料，尤其是生理相容性金屬，諸如鈦或不銹鋼或合金，或任何生理相容性塑膠，例如PEEK。桿件可由金屬或塑膠製成，視用途而定，即桿件是否應具有純固設或動態穩定。栓塞構件的材料和固定件材料相同，亦可為不同材料。栓塞構件的適當材料，特別是鈦和鈦合金、植入物所用不銹鋼，和PEEK。
栓塞構件的第二具體例如第9圖所示。栓塞構件40呈球形，球直徑比第二部的徑孔11內徑大，比幹部7在主部的徑孔11內徑小。球形栓塞構件40宜由高比重材料，諸如金屬製成為宜，使栓塞構件40可以引進，並藉自重落下。
第10圖表示骨骼固定件的第三具體例，其栓塞構件41與栓塞構件30不同，只在不包括保持彈簧35，在與工具結合用的第二圓筒部設有凹部42，以取代保持彈簧35。所有其他部份均與栓塞構件30一致。
雖然多軸式骨骼螺釘所示為包括骨骼固定件之骨骼固定裝置，但本發明包括任何其他骨骼固定件。例如，可用單軸式骨骼螺釘，其中骨骼固定件2的頭部形狀，得以容納桿件。骨骼固定件且不需在幹部設有骨骼螺紋。亦可設計成推轉式固定件，在倒鉤元件，滯留於骨骼內。骨骼固定件亦可設計骨骼釘，有滑順外表面。
栓塞構件亦可構想其他修飾，例如栓塞構件可呈碟形、錐形或任何其他形狀。
茲參見第11和12圖說明可將栓塞構件***骨骼固定件內之工具第一具體例。工具50特別適於***第4-8圖所示型式之栓塞構件。工具50包括持握手柄51，和延伸穿過手柄51之插管52。插管52空心，其長度至少等於幹部長度，得以把栓塞構件30定位在徑孔11末端。管52的內徑使管 52可置於栓塞構件的支座上，故保持彈簧連同掣子36可向內運動至某一程度。如此，可持握管52的末端。插管52在內側末端有凹部，與掣子36合作。管52的外徑比徑孔11內徑稍小，故插管52可引進入徑孔11內。插管52延伸貫穿手柄51，使管52的開口端53與手柄51的端部實質上齊平。第11圖表示固定件2、栓塞構件30和工具50之分解圖。在第12圖中，栓塞構件30利用工具50夾持。由於管52延伸貫穿手柄51，可將導線導引穿過開口端53，進入管部。
第13和14圖表示工具第二具體例相對於骨骼固定件之二位置。
此具體例之工具60是由注射器60形成。注射器60特別適於把骨水泥或藥劑物質注入骨骼固定件2內。包括胴部，有持握手柄61，和活塞62，把骨水泥或物質推進到針或管63內。針或管63之設計，能夠夾持栓塞構件30，或結合入栓塞構件41之凹部42內。針或管63有足夠長度使栓塞構件可置於徑孔11末端。
工具亦可設想修改例。例如，插管52或63可具撓性，以適應骨骼固定件內之非直型溝。具有例如卸除功能，以夾持和釋放栓塞構件之任何其他夾持機制，亦屬可行。
茲參見第15和16圖說明骨骼固定件之用法。第15和16圖表示骨骼固定件利用最少侵襲性手術植入。在步驟(1)中，導線100穿過皮膚101置於脊椎柱的椎骨102內之骨骼固定件最後位置。栓塞構件在此程序階段，不***骨骼固定件內。然後，設備骨骼固定件2或如第15圖所示與容納件3和壓力元件5預組裝之骨骼固定件，把導線100從骨骼固定件之第一端引導穿過骨骼固定件和容納件3。其次，如步驟(2)所示，把骨骼固定裝置1沿導線100導引至椎骨102，係最後植入處，最後旋入梗節內。然後，如步驟(3)所示，除去導線。
第16(a)至(c)圖表示步驟(4)，引進栓塞構件。如 第16(a)圖所示，使用工具50把栓塞構件30引進入骨骼固定件2內。第16(b)圖表示側視圖，而第16(c)圖是固定件2擴大部之斷面圖，栓塞構件30利用管52***。栓塞構件30是由工具50的管52夾持，並將管52引進入骨骼固定件內。栓塞構件30再脫開工具，係將導線100***(圖上未示)，把導線100對栓塞構件推，使栓塞構件最後置於肩部13上，封閉骨骼固定件。然後，把骨水泥或藥劑物質經開口15，注入到周圍骨骼材料。不能經骨骼固定件的自由端出去，因為自由端被栓塞構件封閉。此造成安全固設，因在自由端無骨水泥漏出，否則會鬆弛固定具或損壞血管結構。
以球形栓塞構件40而言，栓塞構件40只能引進到徑孔11頂部，故藉自重落下，封閉自由端。
在變通方式中，栓塞構件30或41是以注射器60之針63夾持，注射器含骨水泥或藥劑物質，而栓塞構件是藉骨水泥或藥劑物質注入徑孔11內，直至封閉自由端。
俟至少二骨骼固定件固定後，即將桿件4***，利用保固元件加以固設。
1‧‧‧骨骼固定裝置
2‧‧‧骨骼固定件
3‧‧‧容納件
3a‧‧‧容納件第一端
3b‧‧‧容納件第二端
4‧‧‧桿件
5‧‧‧壓力元件
6‧‧‧保固元件
7‧‧‧幹部
8‧‧‧頭部
9‧‧‧第二端
10‧‧‧骨骼螺紋
11‧‧‧徑孔
12‧‧‧末端部
13‧‧‧肩部
14‧‧‧結合結構
15‧‧‧開口
16‧‧‧共軸徑孔
17‧‧‧U形凹部
18a,18b‧‧‧自由股部
19‧‧‧陰螺紋
20‧‧‧球形凹部
21‧‧‧圓筒形凹部
22‧‧‧共軸徑孔
30‧‧‧栓塞構件
31‧‧‧第一圓筒部
32‧‧‧切角部
33‧‧‧第二圓筒部
34‧‧‧過渡部
35‧‧‧保持彈簧
36‧‧‧掣子
40‧‧‧栓塞構件
41‧‧‧栓塞構件
42‧‧‧凹部
50‧‧‧工具
51‧‧‧持握手柄
52‧‧‧插管
53‧‧‧插管開口端
60‧‧‧注射器
61‧‧‧持握手柄
62‧‧‧活塞
63‧‧‧針或管
100‧‧‧導線
101‧‧‧皮膚
102‧‧‧椎骨
第1圖為骨骼固定件一具體例之分解透視圖；第2圖為第1圖之骨骼固定件在桿件固設時的組合狀態；第3圖為第2圖之骨骼固定件沿包含桿件軸線的平面之截面圖；第4圖為第1-3圖骨骼固定件所用栓塞構件之俯視圖；第5圖為第4圖栓塞構件之透視圖；第6圖為栓塞構件之側視圖；第7圖為栓塞構件之斷面圖；第8圖為第4-7圖栓塞構件***骨骼固定件之放大斷面圖；第9圖為骨骼固定件具有另一栓塞構件的第二具體例之 放大斷面圖；第10圖為骨骼固定件和又一栓塞構件的第三具體例之放大斷面圖；第11圖為把栓塞構件***骨骼固定件所用工具第一具體例之分解圖；第12圖為具有第11圖工具的骨骼固定件與栓塞構件組合之透視圖；第13圖為具有工具第二具體例的骨骼固定件在注入骨水泥位置之透視圖；第14圖為具有工具第二具體例的骨骼固定件分解圖；第15圖為在最少侵襲性手術中使用骨骼固定件之步驟(1)至(3)；第16(a)至(c)圖表示在最少侵襲性手術中使用骨骼固定件之步驟(4)。
7‧‧‧幹部
9‧‧‧第二端
11‧‧‧徑孔
12‧‧‧末端部
13‧‧‧肩部
15‧‧‧開口
30‧‧‧栓塞構件
31‧‧‧第一圓筒部
32‧‧‧切角部
33‧‧‧第二圓筒部
34‧‧‧過渡部
35‧‧‧保持彈簧

Claims (11)

  1. 一種骨骼固定件，包括：一整體管狀幹部(7)，界定一徑孔，具有開口之一第一端和沿該幹部(7)縱軸線與有開口之該第一端對立之有開口之一第二端(9)，鄰接該有開口之第二端(9)的一第一部之該徑孔直徑，比該幹部(7)之一主要部份小，因而在該幹部(7)內側產生一肩部(13)，該幹部(7)包含複數開口(15)，貫穿該幹部(7)之管狀壁，並與該有開口之第一端和該有開口之第二端(9)隔開；一栓塞構件(30,40,41)，構成以該管狀幹部植入一骨骼內，其中該栓塞構件構成從該第一開口端***該徑孔內，並可導引貫穿該徑孔，沿縱軸線穿出至少該開口(15)之一，至一第一位置，在該有開口之第一端和該有開口之第二端(9)之間封閉該徑孔，而該有開口之第一端和該至少一開口間之途徑，保留開啟；其中當該栓塞構件在徑孔內時，該栓塞構件橫越該縱軸線的一第一斷面之一第一圓筒部(31)，與該栓塞構件橫越該縱軸線的一第二斷面之一第二圓筒部(33)不同，而在該第一圓筒部(31)和該第二圓筒部(33)之間，形成一過渡部(34)，以配合該肩部(13)之形狀者。
  2. 如申請專利範圍第1項之骨骼固定件，其中該徑孔尺寸可容納最少侵襲性手術之一導線(100)進入者。
  3. 如申請專利範圍第1或2項之任一項骨骼固定件，其中該栓塞構件(30,41)係實質上銷形者。
  4. 如申請專利範圍第3項之骨骼固定件，其中該栓塞構件包括一結合結構，可供與一工具結合者。
  5. 如申請專利範圍第4項之骨骼固定件，其中該結合結構包括一保持彈簧(35)者。
  6. 如申請專利範圍第4項之骨骼固定件，其中該結合結構包括一凹部(42)者。
  7. 如申請專利範圍第1或2項之任一項骨骼固定件，其中該第一端包括一頭部(8)者。
  8. 如申請專利範圍第7項之骨骼固定件，其中該頭部(8)連接至一容納件(3)，供容納一桿件(4)者。
  9. 一種骨骼固定總成，包括：一整體管狀幹部(7)，界定一徑孔，具有開口之一第一端和沿該幹部(7)縱軸線與有開口之該第一端對立之有開口之一第二端(9)，鄰接該有開口之第二端(9)的一第一部之該徑孔直徑，比該幹部(7)之一主要部份小，因而在該幹部(7)內側產生一肩部(13)，該幹部(7)包含複數開口(15)，貫穿該幹部(7)之管狀壁，並與該有開口之第一端和該有開口之第二端(9)隔開；一栓塞構件(30,40,41)，構成以該管狀幹部植入一骨骼內，其中該栓塞構件構成從該第一開口端***該徑孔內，並可導引貫穿該徑孔，沿縱軸線穿出至少該開口(15)之一，至一第一位置，在該有開口之第一端和該有開口之第二端(9)之間封閉該徑孔，而該有開口之第一端和該至少一開口間之途徑，保留開啟；其中當該栓塞構件在徑孔內時，該栓塞構件橫越該縱軸線的一第一斷面之一第一圓筒部(31)，與該栓塞構件橫越該縱軸線的一第二斷面之一第二圓筒部(33)不同，而在該第一圓筒部(31)和該第二圓筒部(33)之間，形成一過渡部(34)，以配合該肩部(13)之形狀；一工具，包括一結合部，構成結合該栓塞構件(30,41)，其中該工具構成把該栓塞構件***於該有開口之第一端和該有開口之第二端間之該徑孔內者。
  10. 如申請專利範圍第9項之骨骼固定總成，又包括一引進部，呈管形，設計成可容納入該徑孔(11)內者。
  11. 如申請專利範圍第10項之骨骼固定總成，其中該引進部是由一注射器之針所形成，供注射骨水泥者。
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