TWI527559B - 容納桿件以聯結桿件至骨骼固定元件用之容納件,以及具有如此容納件之骨骼固定裝置 - Google Patents
容納桿件以聯結桿件至骨骼固定元件用之容納件,以及具有如此容納件之骨骼固定裝置 Download PDFInfo
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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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
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Description
本發明係關於容納桿件以聯結桿件至骨骼固定元件用之容納件,以及具有此等容納件之骨骼固定裝置。容納件包含容納件本體,和至少部份位於容納件本體的包含空間內。壓力元件有撓性部以夾持頭部。壓力元件可在容納件本體內,設有***位置,得以引進和取出頭部;鎖定位置,把頭部鎖定於容納件內;和預鎖定位置,頭部利用壓力元件所施預力夾持。
多軸式骨骼螺釘已知有各種設計,其中頭部是從側面夾持,以鎖定骨骼螺釘之轉動位置。
US 5,672,176號記載一種骨骼螺釘,其容納件有錐形底座和錐形壓力元件,從上面和側面施壓於頭部。若錐體角度值位於特定範圍內,壓力元件即發生自行鎖定於容納件內,得以把頭部預先鎖定在容納件內,而桿件仍然活動,容許調節其位置。
WO 2007/038350 A2揭示一種裝置,把骨骼固定器連接於支持桿件,此裝置含有連接器本體和帽蓋。連接器本體有插座,供骨骼固定器***、轉角度和卸除。設有軸套,其造形可以暫時位置套在連接器本體上,其中軸套容許骨骼固定器***,運動至暫時鎖定位置,此時軸套得以轉角度,但防止骨骼固定器取出,再運動至鎖定位置,此時軸套防止骨骼固定器轉角度和取出。
US 6,063,090號係關於一種裝置,用來連接縱向支持件至梗節螺釘,利用具有凹溝之包容頭部,包容縱件支持件。梗節螺釘和包容頭部,藉包容頭部內之錐形筒夾夾頭和梗節螺釘上的球形頭連接。在梗節螺釘***骨骼後,裝置容許以梗節螺釘結合入包容頭部內。
US 6,132,432號記載一種植入體固設總成,包含骨骼固設構件,諸如螺釘,和桿件容納座,在操作上連接於骨骼固設元件。在一具體例中,設有螺釘頭容納插件,可在總成內,於鎖定位置(抓住螺釘頭)和解鎖位置(螺釘頭可進出)之間活動。
本發明之目的,在於提供一種容納桿件以聯結桿件至骨骼固定元件用之容納件,以及具有此等容納件之骨骼固定裝置,由少數組件組成,在手術當中具有改進處置性能。
此目的是以申請專利範圍第1項之容納件,和申請專利範圍第15項之骨骼固定裝置解決。進一步發展則在申請專利範圍附屬項內規範。
壓力元件可配置於容納本體內三個位置。在***位置,頭部可從底部***容納件本體之包容空間內。在預鎖定位置,壓力元件把頭部預鎖定入包容空間內,以防頭部不慎脫出容納件本體,也防止在手術之際,頭部相對於容納件本體意外運動。如此在手術當中,即可安全處置骨骼固定裝置。在預定位置,頭部終於鎖定在容納件內。壓力元件可解除自如地保持在***位置和預鎖定位置。如此可方便處置。
頭部之預鎖定和最後鎖定,是以同樣壓力元件達成。因此,本發明容納件和骨骼固定裝置包括少數元件,減少生產成本,且方便處置。使用從側面沿周夾持骨骼固定元件的頭部之原理,以減少安全夾持頭部必要之力。容納件的設計容許頭部從容納件底部引入,其優點是可提供模組系統,在手術之前,已有不同容納件的各種骨骼固定器可用。
本發明其他特點和優點,則參見附圖所示具體例之詳細說明。
如第1和2圖所示,第一具體例之骨骼固定裝置包括骨骼固定元件1,形成骨骼螺釘,有螺紋幹部2,和頭部3,在此具體例中是球狀截面形頭部。頭部3有凹部4,可與螺旋工具結合。骨骼固定裝置又包括容納件本體5,供容納桿件6,把桿件連接至骨骼固定元件1。再者,設有封閉元件7,形成內螺釘,把桿件6保固於容納件本體5內。此外,骨骼固定裝置包含壓力元件8,把頭部鎖定於容納件本體5內。壓力元件8例如經由銷9a,9b,保持於容納件本體5內。
茲參見第1和8至14圖說明容納件本體5。容納件本體5包括第一端10和對立的第二端11,以及通過第一端和第二端之對稱軸線M。設有徑孔12,與對稱軸線M共軸。在鄰近第一端10的第一區域內,容納件本體5有U形凹部13,就對稱軸線M對稱,凹部13的底部朝第二端11,二自由側面股部14a,14b朝第一端10延伸。在股部14a,14b區域內,設有陰螺紋15,與內螺釘7螺合。U形凹部13形成之凹溝尺寸,可容納桿件6,連接複數固定裝置。在接近第二端11之第二區,徑孔12之圓筒形部接續第一斜縮部16,以錐體角度朝第二端11斜縮。第一斜縮部16接續第二斜縮部17,以錐體角度朝第二端11斜縮,其角度較第一斜縮部為小。在第二端11設有開口18。開口18直徑較頭部3直徑為大,比徑孔12內徑小。共軸徑孔12具有螺釘頭3之包容空間。
在各股部14a,14b設有徑孔20a,20b,延伸穿過股部14a,14b,以容納銷9a,9b。徑孔位於各股部的大約中心。
由第1和3至7圖可見,壓力元件8基本上包含第一部81,實質上圓筒形,外徑比徑孔12內徑稍小,故壓力元件8可在徑孔12內運動;和第二部82,比第一部凹低,最大外徑比徑孔12內徑為小。第一部81在與第二部82對立的末端,有U形凹部83,當壓力元件8位於容納部本體5內時,可容納桿件6。在U形凹部側面,壓力元件包括在外壁之長形凹部84,配置成彼此對立並對齊,使其長側與容納件本體5之對稱軸線M平行。由第4圖可見,第一部81側面寬度朝自由端遞減。
第二部82形成類似軸環,包括第一端,在第一部81的側面,較第一部81凹陷;第二端;和空心內部85,呈實質上球形,以夾持球形頭部3。第二部82的第二端有開口86,供引進頭部3。第二部82的外壁包括第一部87,呈球形,而第二部88鄰近開口86呈斜縮。斜縮部88與容納件本體的第二斜縮部17協合。壓力元件的第二部82又包括複數開縫89,從開口86邊緣延伸貫穿第二部82。開縫89數目和維度使第二部之壁充分撓性,在頭部3***時,可套在頭部3上。又,壓力元件包括共軸徑孔90,供工具存取螺釘頭。
由第8-14圖可見,由於壓力元件最大外徑比徑孔12內徑稍小,可從第一端10***容納件本體5內。一旦***時,銷9a,9b即引進入徑孔20a,20b內,結合於長形凹部84內,因而保持壓力元件,其U形凹部83與容納件本體之U形凹部13對齊,防止壓力元件從第一端脫出。由於壓力元件之第二部82外徑比徑孔12的內徑小,又因壓力元件之第二部82有撓性外壁,在引進螺釘頭時,第二部可在包容空間19內擴張。
上述所有組件均由生物相容性材料製成,諸如生物相容性金屬,像不銹鋼或鈦,或生物相容性合金,諸如鎳鈦諾(nitinol),或由生物相容性塑膠材料製成,例如PEEK。
茲參見第8-14圖說明骨骼固定裝置的組合步驟。首先,當壓力元件8引進到容納件本體,並用銷9a,9b保持,其定向是使開口86指向容納件本體之第二端11。如第8圖所示,壓力元件8在其最頂上位置,即***位置,使螺釘頭3得以***。在***位置,壓力元件之撓性第二部自由位在包容空間19內。***位置是利用毗連件限制,對抗向上運動,在此具體例中,是利用銷與凹部84下端結合,提供毗連件。如第9圖所示,再將螺釘頭3插穿開口18,進入包容空間19內,壓力元件8之第二部82即位於此。螺釘頭3穿過開口86引進入壓力元件的第二部82之空心內部85內。由於開縫89提供撓性壁,第二部即擴張進入包容空間19,如第9圖所示。第二部套在螺釘頭3上,直至包圍螺釘頭3,如第10圖所示。在螺釘頭***時,銷亦防止壓力元件8經開啟的第二端10脫出。在***位置,螺釘頭3可在容納件內樞動,若壓力元件保留在其原位,亦可拆下。亦可有機構(圖上未示),把壓力元件暫時保持在***位置。另外,壓力元件亦可利用工具(圖上未示)保持在***位置。
第11和12圖表示壓力元件之預鎖定位置。當螺釘頭3***,壓力元件稍往下壓,壓力元件之第二部82外壁,即被第一斜縮部16導引,故接觸到容納件本體之第二斜縮部17。壓力元件外壁之斜縮部88和斜縮部17即告結合,因而由壓力元件的第二部82對螺釘頭3施以預力,把頭部3預鎖定。預鎖定意指在手術引發的狀態下,維持骨骼固定元件1相對於容納件本體5之角度位置,只有對容納件本體或螺釘元件施以額外力量才能鬆開。壓力元件之預鎖定位置之達成,可藉手動把壓力元件向下推,或***桿件並旋入內螺釘7,故桿件壓到壓力元件,藉此稍微向下移。
第13a和13b圖表示壓力元件的外表面部和容納件本體的內表面部,在預鎖定狀態下結合。如前所述,表面17,88可斜縮,如第13a圖所示。另外,表面88',17'可圓滑,如第13b圖所示。在容納件本體5的第一斜縮部16,只用來導引,可以省略。
在第13c圖中,二斜縮部17,88實質以同樣角度斜縮。如此可供壓力元件的第二部88和容納件本體的斜縮部17之間,有實質上平均之壓力分配(如箭頭所示)。第13d和13e圖表示二種不同設計,部份以不同角度斜縮。第13d圖表示主要接觸面積在底部,而第13e圖表示主要接觸面積在頂部17'''。第13f圖表示壓力元件之斜縮部88''''和容納件本體之圓滑部17'''',其曲率朝向容納件本體中心。以此構型,可達成在圓滑部之定位接觸面積。
在第13g及13h圖中,容納件本體5修飾例之狹窄部170,各頂面上二彎曲部170a,170b形成雙球形半徑,中間有凹溝170c,曲率朝向中心軸線M。因此,修飾之壓力元件180在其下端有二逆向彎曲部180a,180b,相當於彎曲部170a,170b,其間有凸部180c,而在壓力元件的外屈服邊緣有外凸部180d。
如第13e圖所示,當壓力元件180向下運動,其最低邊緣會結合於凹溝170c內。在此位置,頭部3摩擦夾持,容許頭部3藉施外力而樞動,比頭部3引進入***位置內時,樞動頭部3之力還要大。此為預鎖定狀態。如第13h圖所示,把壓力元件180再向下壓,則壓力元件180的曲率與狹窄部170的曲率結合,最後把頭部3鎖定。
第三位置即鎖定位置,如第14圖所示。鎖定位置定義是,螺釘頭3最後鎖定於容納件本體內時的壓力元件位置。在此位置,壓力元件之斜縮外表面部88,在較大面積結合容納件本體之第二斜縮部17。於是,壓力元件的第二部撓性部壓住頭部3,頭部3即被鎖定。此位置之達成是最後旋緊內螺釘7,把桿件6壓下。
使用時,可例如把骨骼固定裝置預組合,得以選用適當骨骼固定元件1,連同***的壓力元件引進入容納件本體內。稍微把壓力元件向下推,就可進入預鎖定狀態。然後,把螺釘元件旋入骨骼內。頭部3的凹部4可藉螺絲起子穿過共軸徑孔12和徑孔90存取。為使容納件與要連接的桿件準確對齊,無論用手或應用器具,對容納件施以額外力量。一旦達到桿件相對於其他骨骼固定裝置的正確位置,內螺釘7即旋緊,因而把壓力元件向下移至鎖定位置。最後旋緊內螺釘,即同時鎖定桿件和頭部。
骨骼固定裝置可預組合,由廠商為之,或是在手術過程中或準備中,或任何其他時間均可。宜按照臨床應用之特殊要求,在手術之前,由外科醫師選擇骨骼固定元件內必要的容納件。骨骼固定裝置的設計,得以選擇適當骨骼固定元件之固定段直徑、長度和其他特點。因此,提供模組系統,含容納件和若干骨骼固定元件,然後個別選用和適應。
茲參見第15-26圖說明骨骼固定裝置第二具體例,與第一具體例相同的組件,標示同樣參照號碼,即不再贅述。骨骼固定裝置的第二具體例,與第一具體例不同在壓力元件和銷之設計。壓力元件8'與第一部的壓力元件8不同。壓力元件8'的第一部81'有淺凹部83',呈實質上圓筒截段形,供導引桿件6。又含二直立彈性指桿91a,91b,在凹部83的二側面,按容納件本體的第一端10方向延伸。直立指桿在自由端分別有朝外部。第一部83'至少在指桿區域內的外徑,比徑孔的內徑小,使彈性指桿可以運動。
銷9a',9b'各有扁平部93,其寬度實質上和彈性指桿的朝外延伸部92寬度相同。當銷***徑孔20a,20b內時,該部93延伸入容納件本體5之共軸徑孔12內,如第20圖所示。利用此構造,對容納件8'提供毗連件。
第二具體例骨骼固定裝置之組合,可參照第20-25圖說明。在第20圖中,先將壓力元件8'從第一端10***容納件本體5內。再把銷9a',9b'***股部洞孔內。壓力元件8'之位置,使彈性指桿之朝外延伸部92,位於銷之扁平部93上方。在此位置,壓力元件8'即在***位置。再將螺釘頭插穿過開口18和86,直到壓力元件8'的第二部82包圍螺釘頭3。然後如第22圖所示,壓力元件8'稍微向下移動,進入預鎖定位置。因而彈性指桿91a,91b被朝外延伸部92繞銷之扁平部93運動而向內壓。如第23圖所示,朝外延伸部92向外運動,而扁平部93形成壓力元件之毗連件。在此預鎖定位置,第二部82的斜縮外表面部,即與容納件本體之斜縮部17結合。因銷有作動部的作用,可以保全預鎖定位置。
***桿件並旋入內螺釘7,又進一步把壓力元件向下運動,直至達成最後鎖定位置,如第26圖所示。
骨骼固定裝置之臨床使用,類似第一具體例。
圖示具體例可有進一步修飾。例如,骨骼固定元件之頭部可有任何其他形狀,例如圓筒形,因而提供單軸式骨骼螺釘,使螺釘元件可相對於容納件,繞單一軸線轉動。頭部3亦可為錐形,而壓力元件之空心內部85適應此形狀。進一步修飾是,容納件本體5或至少壓力元件之第二部82,係由生物相容性塑膠材料製成,其有某程度之彈性,在此情況下,開縫可省略。
第二具體例的替項是,在容納件本體設彈簧部,與壓力元件之一部份合作。一般而言,銷只是達成壓力元件的毗連件之一例。亦可構想其他構造,諸如套環等。
容納件本體可有傾斜開口端,使頭部在一方向有較大轉角。壓力元件第二部82之外表面部可斜縮,而容納件本體之第二部17則向內彎曲。
1...骨骼固定元件
2...螺紋幹部
3...螺釘頭
4...頭部凹部
5...容納件本體
6...桿件
7...內螺釘
8,8'...壓力元件
9a,9b,9a',9b'...銷
10...容納件本體第一端
11...容納件本體第二端
12...徑孔
13...U形凹部
14a,14b...股部
15...陰螺紋
16...第一斜縮部
17,17'...第二斜縮部
18...開口
19...包容空間
20a,20b...徑孔
81,81'...壓力元件第一部
82...壓力元件第二部
83,83'...U形凹部
84...長形凹部
85...空心內部
86...開口
87...球形外壁
88,88'...斜縮外表面部
89...開縫
90...共軸徑孔
91a,91b...二直立彈性指桿
M...對稱軸線
92...彈性指桿朝外延伸部
93...銷扁平部
170...容納件本體狹窄部
170a,170b...彎曲部
170c...凹溝
180...壓力元件
180a,180b...逆向彎曲部
180c...凸部
180d...外凸部
第1圖為骨骼固定裝置第一具體例之分解透視圖;
第2圖為第1圖骨骼固定裝置組合狀態之透視圖;
第3圖為第一具體例壓力元件之透視圖;
第4圖為第3圖壓力元件之側視圖;
第5圖為第4圖所示壓力元件轉90°之側視圖;
第6圖為第5圖所示壓力元件之斷面圖;
第7圖為第3至6圖所示壓力元件之仰視圖;
第8圖為骨骼固定裝置在壓力元件之第一位置時垂直於桿件軸線之斷面圖,此時骨骼固定元件尚未***;
第9圖為骨骼固定裝置第一具體例在壓力元件第一位置之斷面圖,骨骼固定元件部份***;
第10圖為第9圖骨骼固定裝置在骨骼固定元件完全***狀態;
第11圖為第一具體例骨骼固定裝置之斷面圖,其壓力元件在預鎖定位置;
第12圖為第11圖之細部放大圖;
第13a和13b圖分別為壓力元件和容納件本體內、外合作表面設計之二選項例;
第13c至13h圖分別為壓力元件和容納件本體內、外合作表面設計之其他例;
第14圖為第8圖之骨骼固定裝置,其桿件已***,頭部最後鎖定;
第15圖為骨骼固定裝置第二具體例之分解透視圖;
第16圖為第二具體例壓力元件之放大側視圖;
第17圖為第16圖壓力元件之斷面圖;
第18圖為第16圖壓力元件轉90°之側視圖;
第19圖為第16圖壓力元件仰視圖;
第20圖為骨骼固定裝置第二具體例垂直於桿件軸線之斷面圖,其壓力元件在***位置,而骨骼固定元件尚未***;
第21圖為第20圖之骨骼固定裝置,其骨骼固定元件完全***;
第22圖為第20圖之骨骼固定裝置,其壓力元件之位置在剛要達成預鎖定位置之前;
第23圖為第20圖之骨骼固定裝置,其壓力元件在預鎖定位置;
第24圖為第23圖細部之放大圖;
第25圖為第23圖細部之進一步放大圖;
第26圖為第20圖之骨骼固定裝置,其壓力元件在鎖定位置,而頭部最後鎖定。
3...螺釘頭
5...容納件本體
8'...壓力元件
9a,9b...銷
15...陰螺紋
17...第二斜縮部
18...開口
19...包容空間
88...斜縮外表面部
91a,91b...二直立彈性指桿
M...對稱軸線
Claims (15)
- 一種容納桿件以聯結桿件至骨骼固定元件用之容納件,該容納件包括:一容納件本體(5),具有一凹溝(13),供容納一桿件(6),並界定一徑孔,具有一第一直徑,提供一包容空間(19),供包容該骨骼固定元件之一頭部(3),該容納件本體又界定一開口(18),具有一第二直徑,比該第一直徑小,供***該頭部,其中在該徑孔和該開口之間,形成一邊緣;一壓力元件(8,8'),至少部份在該包容空間內,該壓力元件包括一第一部位,有一凹部供容納該桿件,一第二部位,有一撓性部(82),界定一空心內部,以包容和夾持該頭部,和一開口,由該第二部位的一末端區之一內表面界定,以***該頭部;其中該壓力元件(8,8'),可從供***該頭部之一***位置,沿該容納件本體之一縱軸線,運動至一預鎖定位置,該壓力元件的該第二部位之該末端區一外表面,與該容納件本體之該邊緣結合,利用該壓力元件施加一預力,把該頭部夾持於該容納件本體內,至一鎖定位置,把該頭部鎖定於該容納件本體內者。
- 如申請專利範圍第1項之容納件,其中在該***位置時,該壓力元件(8,8')可在該包容空間(19)內擴張者。
- 如申請專利範圍第1或2項之容納件,其中該***位置被作用於該壓力元件(8,8')之一止動部(9a,9b,84)所限制者。
- 如申請專利範圍第1或2項之容納件,其中在該預鎖定位置,施於該頭部之該預力,係僅由該容納件本體的內壁之一部份,夾持該壓力元件的外壁之一部份(88)所產生者。
- 如申請專利範圍第1或2項之容納件,其中該壓力元件(8')係利用一彈力保持於該預鎖定位置者。
- 如申請專利範圍第5項之容納件,其中該彈力係由該壓 力元件或該容納件本體上之一彈簧部(91a,91b,92),分別與該容納件本體(5)或該壓力元件上之一毗連件(93)合作而產生者。
- 如申請專利範圍第1或2項之容納件,其中在該***位置時,該頭部可從該容納件本體取出者。
- 如申請專利範圍第1或2項之容納件,其中該包容空間(19)具有一圓筒形部,接近該開口為一窄部(17),該窄部宜斜縮或圓滑者。
- 如申請專利範圍第8項之容納件,其中該壓力元件包括在其外壁之一窄部(88),宜斜縮或圓滑,並與該包容空間(19)內之該窄部(17)合作者。
- 如申請專利範圍第1或2項之容納件,其中該壓力元件之該撓性部(82)有一空心段(85)供包容該頭部(3),和一開口(86),供***該頭部者。
- 如申請專利範圍第1或2項之容納件,其中該撓性部(82)之一外徑,較該包容空間(19)之一內徑為小者。
- 如申請專利範圍第1或2項之容納件,其中該容納件本體(5)包括一段,具有一U形凹部,供容納該桿件(6)者。
- 如申請專利範圍第1或2項之容納件,其中該壓力元件(8,8')包括一凹部(83,83'),供容納該桿件者。
- 如申請專利範圍第1或2項之容納件,其中該壓力元件保固於該容納件本體內,以防脫出者。
- 一種骨骼固定裝置,包括申請專利範圍第1或2項中任一項之一容納件,和一骨骼固定元件,有一幹部和一頭部,其中宜設有一封閉元件,將該桿件保固於該容納件內者。
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EP09002468.8A EP2221013B1 (en) | 2009-02-20 | 2009-02-20 | Receiving part for receiving a rod for coupling the rod to a bone anchoring element and a bone anchoring device with such a receiving part |
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JP2010194309A (ja) | 2010-09-09 |
EP2581057A1 (en) | 2013-04-17 |
US20100234902A1 (en) | 2010-09-16 |
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ES2548580T3 (es) | 2015-10-19 |
JP5622402B2 (ja) | 2014-11-12 |
EP2221013B1 (en) | 2015-08-05 |
ES2455122T3 (es) | 2014-04-14 |
EP2221012B1 (en) | 2014-01-01 |
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