TWI498097B - 穩定椎骨本體或骨骼用之植入體 - Google Patents
穩定椎骨本體或骨骼用之植入體 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/74—Devices for the head or neck or trochanter of the femur
- A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
- A61B17/744—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to an intramedullary nail
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
- A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
- A61B17/8858—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc laterally or radially expansible
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
Description
本發明係關於穩定椎骨或骨骼用之植入體。尤指穩定骨質疏鬆的椎骨本體用之植入體。
治療椎骨本體破裂之已知方法,是所謂椎骨手術。把低粘度的骨骼粘合劑以高壓直接注射入椎骨本體破裂處。有一部份骨骼粘合劑會流出椎骨本體,流入周圍面積之虞。如此會造成不適或疼痛,因為骨骼粘合劑會壓到神經或脊髓。而且,超越椎骨端板的血管結構會受損。
治療椎骨本體破裂之另一方法,即所謂脊柱手術。此法包含:先把套管插入破裂的椎骨本體內。再把氣球導管插入椎骨本體內。在X射線監視下注射入流體,使氣球膨脹,因而產生氣球導管容積所界定之腔室。然後,排放流體,除去氣球。下一步驟,把骨骼粘合劑注射入腔室內,骨骼粘合劑可為比椎骨手術所用粘度為高之骨骼粘合劑。雖然骨骼粘合劑逸入周圍之虞,較椎骨手術為低,惟仍不可忽略。又由於腔室尺寸之故,所用骨骼粘合劑量具有實質份量。
二種方法均可應用在衰弱和部份崩壞的骨質疏鬆之椎骨。
椎骨手術和脊柱手術之共同問題是,椎骨本體變得完全僵硬,因超負荷而增加相鄰椎骨本體破裂之可能性。
本發明之目的,在於提供一種穩定椎骨或骨骼用之植入體,以克服上述問題。
此目的是由如申請專利範圍第1項之植入體加以解決。其進一步發展列於申請專利範圍附屬項。
本發明植入體不用骨骼粘合劑即可使用。所以,並無損壞超過椎骨端板的血管結構之虞。改進長期治療成果。植入體形成端板之內部撓性支持體,減少相鄰椎骨破裂之虞。
本發明其他特點和優點,由參見附圖所示具體例之詳述,即可明白。
茲參見第1和2圖說明植入體之第一具體例。植入體1係管狀,有縱軸線L,包括第一端段2和第二端段3,以及中間段4。中間段4由複數縱條5組成,從第一端段2延伸至第二端段3。縱條5間有間隙或長孔6,也是從第一端段2延伸至第二端段3。成對縱條5分別經由橫條7彼此連接,按縱向看大約在其中點,因此,二縱條5和連接橫條7,形成條單位8。由圖上可見,每隔一長孔6即延伸入管狀端段2,3。縱條5賦予中間段4以撓性,其方式如第2圖所示,中間段4可藉條單位向外彎曲而膨脹像氣球,因而擴張條單位間8之長孔6。植入體的維度使其可插通椎骨的梗節所形成洞孔,而進入椎骨本體。尤其是選用中間段4的長度,使得在第2圖所示膨脹狀態時,中間段4可容納入椎骨本體內。可選擇縱條和橫條數目、其形狀、距離和厚度,使膨脹植入體具有所需彈性和所需維度。
植入可由生理相容性材料製成,尤其是生理相容性金屬,諸如鈦,或生理相容性塑膠,諸如PEEK(聚芳基醚醚酮)。特別適用材料有諸如形狀記憶性合金、顯示形狀記憶性能和/或超彈性。適當材料之一例為鎳鈦合金,諸如鎳鈦諾(nitinol)。
植入可用管製成,中間段4是管切成長孔,產生條狀,例如利用雷射裁切製成。
由第1和2圖可見,第一端段2比第二端段3短,而第一端段2有封閉端(圖上未示)。第一端段2用做基端段,先引導進入椎骨本體內,而第二端段3適於與工具或其他植入體組件結合。
第3圖表示植入體修飾具體例1'之透視圖,與第1和2圖所示植入體1不同在於膨脹中間段4'之形狀。其他組件均相同,故不贅述。雖然第2圖所示中間段4大約呈球形或橢圓形,惟第3圖中植入體1'之中間段4'包括長條5'之平坦部5a',與縱軸線L平行延伸。長條5'形狀使中間段4'膨脹時,會形成大約多面形,往第一端段2和第二端段3斜縮。
須知膨脹中間段4之任何所需形狀,可藉適當方式設計縱條和橫條之圖型達成。例如中間段4可設計成線圖型,從第一端段2延伸至第二端段3,並加以熔接,或利用中間橫條連接,呈開口網狀方式。撓性是因提供間隙所達成,當植入體在軸向壓縮時,容許中間段4在徑向膨脹。中間段4亦可預先膨脹至某種程度。由於撓性之故,預膨脹中間段可在徑向壓縮。
植入體之功能可參見第4和5圖說明。第4和5圖所示植入體1,有二相鄰橫條7,形成一寬橫條。惟如上所述,長條之任何形狀和橫條及縱條之圖型,可藉長條之特殊形狀和特殊維度達成。第4圖顯示植入體1之中間段4呈未膨脹狀態。植入體1的長度從第一端段2的最外端到第二端段3的最外端,直徑d1
在中間段4中心。植入體1以第一端段2頂住止動件或銜接件9。銜接件是例如椎骨本體之內壁部。在軸向施力F壓住植入體1,以第一端段2頂住銜接件9,如第5圖所示,中間段4即像氣球膨脹,呈現的形狀在本具體例中大略為球形或橢圓形。在此膨脹狀態中,植入體的長度小於,直徑d2
大於未膨脹狀態之直徑d1
。因此,中間段4呈撓性,在軸向施力,可在徑向膨脹,減少第一端段2和第二端段3間之距離。
植入體之第二具體例10,如第6和7圖所示。與前述具體例相同之部份,以同樣參考數字標示,不另贅述。植入體10與前述具體例之植入體不同,包括拉力元件11,設在管狀植入體內側,連接於一端,圖示具體例是連接於第一端段2。延伸貫穿中間段4和第二端段3,到外側。在第一端段2的相反端,拉力元件11包括端部12,可形成方便夾持。端部12的直徑比第二端部3的直徑大,故端部12形成第二端部3的止動件。拉力元件11可以例如桿或線。可由生理相容性材料製成。第二具體例的植入體10之功能,與前述具體例不同,其中止動件9'必須設在第二端部3。在軸向施力F',把拉力元件11拉離止動件9'時,植入體10在軸向被壓縮,從長度變成更小的長度,而中間段4從直徑d1
膨脹至直徑d2
。
第二具體例可用於基部第一端段2不可能設有止動部的情況。
茲參見第8至11圖說明植入體之使用。第8至10圖表示椎骨100之俯視簡圖,第11圖是側視圖。椎骨本體101例如因骨質疏鬆或破裂而受傷(圖上未示)。首先,如第8圖所示,在椎骨100梗節製備洞孔,到達受傷的內椎骨本體101。把植入體1插入洞孔內,如第9圖所示,推入椎骨本體101內,直到端段2頂住內壁,形成植入體的止動件9。把植入體1推到頂住止動件9時,中間段4即膨脹入椎骨本體內。由第11圖可見,可在中間段4區域內壓縮到某種程度之膨脹植入體,形成端板103之撓性支持體,因而近似椎骨本體之彈性。藉此減少相鄰椎骨破裂造成相鄰椎骨之過度應力。
例如利用封閉螺釘(圖上未示)旋入洞孔102內,壓住第二端段3,把洞孔封閉,即可保持植入體1定位。
如第10圖所示,中間段4完全膨脹。惟中間段亦可僅部份膨脹。當中間段未完全引進入椎骨本體,而有部份中間段4受到洞孔102周壁拘限時即是如此。
如第12圖所示,單一椎骨可用二植入體,分別從左、右梗節插入。此舉可提供更對稱的穩定。外科醫師可按照臨床情形,選用一或二植入體。
第13至15圖表示植入體之第三具體例。植入體20與前述具體例不同,在第二端段之結構。與前述具體例相同之植入體20其他組件,以同樣參考號數標示,不予贅述。植入體20包括端段3',比前述具體例之植入體端段3加長。第二端段3'包括有陽螺紋之部份21,最好設在背離中間段4之末端。陽螺紋可為公制螺紋。第二端段的長度是在第15圖所示插入狀態時,第二端段3'延伸貫穿梗節區域。
植入體又包括軸套22,設有骨骼螺紋,與洞孔102內壁結合。取代骨骼螺紋,軸套22的外徑可較洞孔102直徑稍微過大尺寸,使梗節洞孔和軸套間形成壓套連接,或加以粗糙化,利用摩擦保持在洞孔102內。軸套22在一端又包括有陰螺紋之部份23,與植入體第二端段3'的部份21之陽螺紋嚙合。軸套長度與梗節洞孔102大約相同。軸套在梗節洞孔102內定向方式,使有陰螺紋的部份23背向椎骨本體101之中心。
使用時,首先把軸套22插入洞孔102內,再把植入體20引導穿過軸套22,直到植入體和軸套的螺紋部21和23分別結合。把植入體進一步旋入軸套內,直至第一端段頂住椎骨本體之內壁,中間段4即膨脹,充填於椎骨本體之一部份。膨脹之植入體形成撓性支持體,穩定椎骨本體,不必使用骨骼粘合劑。
此具體例亦可加以修飾。第二端段3'可由二件製成,其中包括陽螺紋的部份,製成分開件,可連接於植入體。中間段4可轉動自如固設於第二端段3',使得旋入第二端段3'時,對中間段只發生軸向力,即中間段4在前進到椎骨本體內時,不會轉動。端段不需呈管狀,可有任何其他截面,代替圓形截面。可以彎曲,而非直線。
亦可構想植入體和軸套之其他連接機構,例如壓套連接。
亦可把植入體連接於其他植入體組件,諸如把脊椎桿或其他組件連接於椎骨之螺釘頭。第16圖表示椎骨100之簡略俯視圖,有二植入體20'和20"和相對應軸套22',22"。一植入體20'以其第二端段3'單軸式連接至容納件24,容納脊椎桿104,以螺釘固定。另一植入體20"以其端段3"多軸式連接於容納件25,容納桿104',利用螺釘固定。
植入體另外臨床使用於支持長骨(像股骨頭段、脛骨高丘,和其他骨骼部位)之衰弱或破裂骨骼結構。第17圖表示應用植入體200來支持股骨頭201。植入體200之第二端段203連接至骨骼螺釘204,其本身可連接至骨髓釘205。其他螺釘206可按通常設備。
1,1'...植入體
2...第一端段
3,3',3",203...第二端段
4,4'...中間段
5,5'...縱條
5a'...長條平坦部
6,6'...長孔
7...橫條
8...條單位
L...縱軸線
...植入體長度
d1
,d2
...直徑
9,9'...止動件
F,F'...軸向施力
10,20,20',20",200...植入體
11...拉力元件
12...端部
21...有陽螺紋的部份
22,22',22"...軸套
23...有陰螺紋的部份
24,25...容納件
100...椎骨
101...椎骨本體
102...洞孔
103...端板
104,104'...脊椎桿
201...股骨頭
204...骨骼螺釘
205...骨髓釘
206...螺釘
第1圖為植入體具體例呈可插入狀態之透視圖;
第2圖為第1圖植入體呈膨脹狀態之透視圖;
第3圖為植入體修飾具體例之膨脹狀態圖;
第4圖為第1圖植入體在膨脹前頂住止動件之透視圖;
第5圖為第4圖植入體之膨脹步驟圖;
第6圖為植入體第二具體例在膨脹前頂住止動件之狀態圖;
第7圖為第6圖植入體之膨脹狀態圖;
第8至11圖為植入體插入椎骨內並加以膨脹之步驟圖;
第12圖表示有二植入體插入和膨脹;
第13圖為植入體第三具體例與梗節軸套一起使用之側視圖;
第14圖為第13圖植入體部份斷面圖;
第15圖為具有梗節軸套的椎骨本體與第13和14圖植入體之簡略斷面圖;
第16圖為植入體之另一應用例;
第17圖為植入體之又一應用例。
1...植入體
2...第一端段
3...第二端段
4...中間段
5...縱條
6...長孔
7...橫條
8...條單位
Claims (10)
- 一種穩定椎骨本體或骨骼用之植入體,包括:一第一端(2);和一第二端(3,3');一管狀段(4,4'),介於該第一端(2)和該第二端(3,3')之間,具有一縱軸線(L);該管狀段(4)具撓性,有一力(F,F')作用於軸向時,可在徑向膨脹,減少該第一端(2)和該第二端(3)間之距離;其中該植入體含有一軸套(22);其中該軸套(22)包括在一端之第一開口和對立端的第二開口,供導引該管狀段(4,4')貫穿至植入處;其中該軸套(22)包括一結合結構(23),與該第一端(2)所設一結合結構(21)結合;其中該軸套(22)又包括陽螺紋,供與椎弓根內設備的洞孔(102)內壁結合者。
- 如申請專利範圍第1項之植入體,其中該管狀段(4,4')係由長條(5,5')形成,從該第一端(2)至該第二端(3)之方向延伸,其末端分別連接至該第一端和該第二端者。
- 如申請專利範圍第1或2項之植入體,其中該管狀段(4,4')包括壁上之縱向長孔(6,6')者。
- 如申請專利範圍第1或2項之植入體,其中該管狀段(4,4')具有一開口網狀結構者。
- 如申請專利範圍第1或2項之植入體,其中至少該管狀段(4)係由顯示超彈性之一形狀記憶合金製成者。
- 如申請專利範圍第1或2項之植入體,其中設有一拉力元件(11),作動時,即縮短該管狀段(4,4')之長度者。
- 如申請專利範圍第1或2項之植入體,其中該末端(2,3)至少其一是管狀者。
- 如申請專利範圍第1項之植入體,其中該結合結構(21,23)係一螺紋者。
- 如申請專利範圍第1項之植入體,其中該軸套(22)包 括一陽螺紋者。
- 如申請專利範圍第9項之植入體,其中該陽螺紋係一骨骼螺紋者。
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US1752307P | 2007-12-28 | 2007-12-28 | |
EP07025214A EP2074956B1 (en) | 2007-12-28 | 2007-12-28 | Implant for stabilizing vertebrae or bones |
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TWI498097B true TWI498097B (zh) | 2015-09-01 |
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TW097150343A TWI498097B (zh) | 2007-12-28 | 2008-12-24 | 穩定椎骨本體或骨骼用之植入體 |
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US (2) | US8784491B2 (zh) |
EP (2) | EP2441402B1 (zh) |
JP (1) | JP5358177B2 (zh) |
CN (1) | CN101530343B (zh) |
ES (2) | ES2607605T3 (zh) |
TW (1) | TWI498097B (zh) |
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ES2390482T3 (es) | 2012-11-13 |
JP5358177B2 (ja) | 2013-12-04 |
US9439770B2 (en) | 2016-09-13 |
EP2441402A1 (en) | 2012-04-18 |
EP2074956A1 (en) | 2009-07-01 |
CN101530343A (zh) | 2009-09-16 |
US8784491B2 (en) | 2014-07-22 |
TW200927064A (en) | 2009-07-01 |
CN101530343B (zh) | 2013-03-13 |
ES2607605T3 (es) | 2017-04-03 |
US20090204216A1 (en) | 2009-08-13 |
EP2441402B1 (en) | 2016-10-26 |
EP2074956B1 (en) | 2012-06-27 |
US20140288651A1 (en) | 2014-09-25 |
JP2009160399A (ja) | 2009-07-23 |
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