TWI566739B - Improved interbody fusion device and implant instrument and method of operation thereof - Google Patents

Improved interbody fusion device and implant instrument and method of operation thereof Download PDF

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TWI566739B
TWI566739B TW102134229A TW102134229A TWI566739B TW I566739 B TWI566739 B TW I566739B TW 102134229 A TW102134229 A TW 102134229A TW 102134229 A TW102134229 A TW 102134229A TW I566739 B TWI566739 B TW I566739B
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cage
implant device
interbody
interbody cage
clamping
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TW102134229A
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Chinese (zh)
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TW201511730A (en
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Fon Yih Tsuang
Chia Hsien Chen
Chang Jung Chiang
Yi Jie Kuo
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Baui Biotech Co Ltd
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改進的椎間融合器及植入器械及其操作方法 Improved interbody fusion cage and implant device and method of operation thereof

本發明涉及一種改進的椎間融合器及植入器械及其操作方法,尤指一種可植入相鄰的椎骨之間的椎間融合器,以及用以實施植入椎間融合器的植入器械及其操作方法。 The present invention relates to an improved interbody cage and implant device and method of operation thereof, and more particularly to an interbody fusion cage implantable between adjacent vertebrae and an implant for implanting an interbody fusion cage Instruments and methods of operation.

脊椎疾病大都是由長期姿勢不正確、運動傷害或是隨著年齡老化等因素所造成的,許多脊椎病變,如椎管狹窄或椎間盤突出等,當病發時經常會伴隨著嚴重的坐骨神經痛、跛行或神經病變等症狀,特別是,當一個椎間盤(Intervertebral disc)之後部毀損時,脊椎的伸展會使兩個脊椎骨(vertebral body)由該盤分離並不正常地互相靠攏,這結果會使神經根被陷住並產生嚴重的疼痛感覺,導致病人在行動上產生困擾。 Spinal diseases are mostly caused by long-term posture errors, sports injuries or ageing. Many spinal lesions, such as spinal stenosis or intervertebral disc herniation, are often accompanied by severe sciatica when the disease occurs. Symptoms such as limp or neuropathy, especially when the posterior portion of an intervertebral disc is damaged, the extension of the spine causes the two vertebral bodies to separate from the disc and not close together normally, which results in nerves. The roots are trapped and cause a severe pain sensation, causing the patient to be troubled by the action.

通常這類脊椎病變是無法使用藥物治癒的,而經過驗證的有效方式是以外科手術治療,在故障的相鄰二椎骨之間植入椎間融合器(Spinal Interbody Fusion Cage)以重建椎間高度,限制相鄰二椎骨之延伸向彼此不正常的靠攏,革除壓迫神經的狀況,以避免病人在行動時產生疼痛等不利特徵。 Usually such spinal lesions cannot be cured with drugs, and a valid and validated method is surgical treatment. A Spinal Interbody Fusion Cage is implanted between the failed adjacent vertebrae to reconstruct the intervertebral height. Limiting the extension of the adjacent two vertebrae to an abnormally close to each other, eliminating the condition of compressing the nerves, so as to avoid adverse characteristics such as pain in the patient's action.

由於椎間融合器安裝部位附近通常佈滿神經與大血管,因此為免破壞這些組織造成對病患的傷害,在臨床上,開創的傷口將會盡量的小,以便在手術施作過程中能有效閃避神經與大血管組織; 於是,目前微創手術已被廣泛應用在椎骨病變的治療,因其開設的傷口小、可大幅降低對治療部位及附近組織的破壞性,增益手術安全性。 Because the nerve cage and the large blood vessel are usually covered near the installation site of the interbody fusion cage, in order to avoid damage to the tissue, the wounds will be as small as possible in order to be able to perform during the operation. Effectively evading nerves and large blood vessels; Therefore, minimally invasive surgery has been widely used in the treatment of vertebral lesions. Because of its small wounds, it can greatly reduce the destructiveness of the treatment site and nearby tissues, and enhance the safety of surgery.

然而,在實際應用中,為了對兩節椎骨之間提供適當的穩定性,一般的椎間融合器在形狀的設計上必須與安裝部位的椎骨形狀相應,例如是外型呈豌豆狀或彎月形,且其尺寸規格不能太小,例如長度在35mm以上,以免受力面積不足造成受力部位崩壞;為了順利將椎間融合器安裝在椎骨上的正確位置及角度,在以往,即使是使用微創手術,其所開設的傷口仍至少需5公分,以供相關手術器械及植入椎間融合器寬度可以通過。因此,提供一種可盡量縮小手術傷口的椎間融合器結構及其植入方法,乃為相關業者努力的課題之一。 However, in practical applications, in order to provide proper stability between the two vertebrae, the general interbody cage must be designed in accordance with the shape of the vertebrae of the installation site, for example, the shape of the peas or the meniscus. Shape, and its size can not be too small, for example, the length is more than 35mm, to avoid the collapse of the force part caused by insufficient force area; in order to smoothly install the intervertebral cage on the correct position and angle of the vertebrae, in the past, even With minimally invasive surgery, the wound is still required to be at least 5 cm for the relevant surgical instruments and the width of the implanted interbody cage to pass. Therefore, it is one of the subjects of the related art to provide an interbody cage structure and an implantation method thereof which can minimize the surgical wound.

於先前技術中,例如同為本案發明人所研發創作的美國專利公開號US 2012/0209383 A1「INTERVERTEBRAL CAGE AND IMPLANTING APPARATUS AND OPERATING METHOD THEREOF」(椎間融合器及植入器械及其操作方法)乙案,揭露一種符合微創手術需求的椎間融合器及植入器械及其操作方法,椎間融合器可以使用微創手術植入相鄰的兩個椎骨之間以重建椎間高度,特別是,該椎間融合器包括一接合部,該接合部具一貫口在側牆設有由數個相鄰排列的內弧面;該植入器械包括一套筒與一前端設有卡合柱的桿體,藉由操控該套筒與桿體之間作軸向的伸縮,使卡合柱可選擇地嵌接或不嵌接於椎間融合器接合部的貫口中,因此植入器械可夾持或釋放椎間融合器;又,利用變換植入器械之卡合柱與椎間融合器接合部的不同內弧面之嵌接位置,以調整植入器械與椎間融合 器的夾持角度;據此在椎間融合器植入手術過程中,植入器械將椎間融合器沿長軸方向夾持,以便椎間融合器可由最小寬度部位通過導管進入安裝部位,當進入安裝部位後,再藉由變換植入器械與椎間融合器之間的不同夾持位置,使椎間融合器被往橫向旋轉擺置,以符合安裝部位所需的擺置角度。 In the prior art, for example, US Patent Publication No. US 2012/0209383 A1 "INTERVERTEBRAL CAGE AND IMPLANTING APPARATUS AND OPERATING METHOD THEREOF" (intervertebral fusion device and implant device and its operation method) The invention discloses an intervertebral cage and an implant device and a method for operating the same, and the interbody cage can be implanted between two adjacent vertebrae by minimally invasive surgery to reconstruct the intervertebral height, in particular The interbody cage includes a joint having a consistent opening on the side wall provided with a plurality of adjacently arranged inner arc surfaces; the implant device includes a sleeve and a front end having a snap post The rod body is axially stretched between the sleeve and the rod body, so that the engaging post can be selectively engaged or not engaged in the joint of the intervertebral cage joint, so that the implant device can be clamped Holding or releasing the interbody fusion cage; in turn, adjusting the engagement position of the different inner arc surfaces of the engagement post of the implant device and the interbody fusion cage to adjust the fusion of the implant device and the intervertebral body The clamping angle of the device; accordingly, during the interbody fusion device implantation procedure, the implant device clamps the interbody cage along the long axis direction so that the interbody cage can enter the installation site through the catheter from the smallest width portion. After entering the installation site, the interbody cage is rotated in a lateral direction by changing the different clamping positions between the implant device and the interbody cage to conform to the placement angle required for the installation site.

前述方案可較傳統的手術大幅縮小傷口,可是它卻也存在著操作不易的問題,例如,當植入器械夾持或釋放椎間融合器時,需旋轉卡合柱並使其通過椎間融合器上的細小槽縫才可與接合部的貫口嵌接或脫離,所以操作上頗具難度,特別是,當精密操作完成將椎間融合器安裝在椎骨之間的正確位置之後,常因操作卡合柱脫離前述細小槽縫時,又不慎造成椎間融合器偏移正確位置,導致須重新進行椎間融合器的安裝定位;另外,手術過程中,欲調整植入器械與椎間融合器的夾持角度時,需使卡合柱與貫口上不同位置的特定內弧面嵌合,但因這項變換角度操作時,植入器械的卡合柱與椎間融合器均深入位於人體內,無法以目視操作,只能憑藉觸感與經驗而操作,困難性極高,且依照該組合構造可調整夾持的角度不多,局限了植入手術的精準度。 The foregoing solution can significantly reduce the wound compared with the conventional surgery, but it also has the problem of difficulty in operation, for example, when the implanted device holds or releases the interbody cage, it is necessary to rotate the engaging post and pass it through the interbody fusion. The small slot on the device can be engaged or disengaged from the joint of the joint, so it is difficult to operate, especially after the precise operation is completed to install the cage between the vertebrae. When the engaging column is separated from the small slot, the position of the intervertebral cage is inadvertently displaced, resulting in the repositioning of the interbody cage. In addition, during the operation, the implant device and the intervertebral fusion are to be adjusted. When the clamping angle of the device is required, the engaging column and the specific inner arc surface at different positions on the cross-port are required to be fitted, but when the angle is changed, the engaging column and the interbody cage of the implanting device are deeply located in the person. In the body, it is impossible to operate visually, and it can only be operated by touch and experience. The difficulty is extremely high, and the angle of the adjustable clamping according to the combined structure is not much, which limits the precision of the implantation operation.

有鑒於此,本發明主要目的乃提供一種改進的椎間融合器及植入器械及其操作方法,其藉由在植入器械設有由二彈性夾臂組成的鉗口部,搭配於椎間融合器上設置軸柱,使椎間融合器與植入器械之嵌接組合或分離的操作成為簡易而快速,且利用在該鉗口部及軸柱設置單向齒,使植入器械與椎間融合器組合後,具有易於變換椎間融合器的植入角度及調整安裝位置的優點,因此本發明 可增進植入手術操作的簡易性,以及提升手術安全性與成功率。 In view of the above, the main object of the present invention is to provide an improved interbody cage and implant device and method of operating the same, which is provided with a jaw portion composed of two elastic clip arms in the implant device, and is matched with the intervertebral space. The shaft column is arranged on the cage, so that the operation of combining or separating the interbody cage and the implant device is simple and rapid, and the one-way tooth is arranged on the jaw portion and the shaft column to make the implant device and the vertebra The combination of the inter-cluster has the advantages of easy to change the implantation angle of the interbody cage and adjust the installation position, so the present invention It can improve the ease of implant operation and improve the safety and success rate of surgery.

為了達成上述發明目的,本發明提供一種椎間融合器,其可植入相鄰的二椎骨之間以重建椎間高度,該椎間融合器的主體包含一上墊板以及一下墊板,上墊板與下墊板之間保持間隙,並由複數立部連結成一籠型體;該主體外型係呈一豌豆形狀或新月形狀,且主體的長向尺寸大於寬向尺寸;在主體的長向中心軸線之前端具一流線型的導引頭,以及在長向中心軸線的後端面設有一開口,於該開口內具一立向設置的軸柱,且於軸柱外周緣設有複數個單向齒。 In order to achieve the above object, the present invention provides an intervertebral cage that can be implanted between adjacent vertebrae to reconstruct an intervertebral height. The body of the interbody cage includes an upper pad and a lower pad. a gap is maintained between the backing plate and the lower backing plate, and is joined by a plurality of vertical portions into a cage shape; the outer shape of the body is in the shape of a pea or a crescent, and the longitudinal dimension of the main body is larger than the width dimension; The front end of the long central axis has a first-line type of seeker, and an opening is formed on the rear end surface of the long central axis, and an axially disposed shaft column is arranged in the opening, and a plurality of shafts are arranged on the outer circumference of the shaft column. One-way tooth.

特別是,在所述上墊板與下墊板之向外側的表面上設有由多數鋸齒狀條紋或凹凸狀的壓花圖案所構成的止滑構造。 In particular, a non-slip structure composed of a plurality of zigzag stripes or embossed patterns having irregularities is provided on the outer surface of the upper and lower pads.

特別是,所述單向齒為棘齒。 In particular, the one-way tooth is a ratchet.

特別是,所述單向齒係可選擇地設置在該軸柱的整個外周緣或是只有在該軸柱外周緣的一部分。 In particular, the one-way tooth system is optionally disposed over the entire outer circumference of the shaft column or only a portion of the outer circumference of the shaft column.

特別是,該椎間融合器還包括至少二個定位標靶,各個定位標靶以彼此分隔儘量遠離的設置於主體上;所述定位標靶為一設在主體上的鏤空部,或是一種設在主體上且使用與本體相異材質的材料所製成的物體。 In particular, the interbody fusion cage further includes at least two positioning targets, each of which is disposed on the main body as far apart as possible from each other; the positioning target is a hollow portion disposed on the main body, or a type of An object made on a body and made of a material different from the body.

本發明再提供一種植入器械與椎間融合器之組合的操作方法,包括:提供一椎間融合器,該椎間融合器具一軸柱,且於軸柱外周緣設有複數個單向齒;提供一植入器械,該植入器械主要包含一夾桿及一滑套,該夾桿的下端部位具二彈性夾臂,在二彈性夾臂的外側分別設有由內向外漸擴的斜面,以及二彈性夾臂末端的內 側分別設有相對稱的C字型的顎部以共同構成一鉗口部,並在至少一C字型顎部上設有複數個單向齒,該滑套可串套在前述夾桿上,使該滑套的下端緣套口可環套於前述二彈性夾臂的外側斜面附近,並令該夾桿的鉗口部敞露於該滑套的下端緣套口之外;以及組合該椎間融合器與植入器械,將該植入器械的鉗口部扣接於該椎間融合器的軸柱上,移動該滑套的下端緣套口抵頂二彈性夾臂的外側斜面,使鉗口部將該椎間融合器的軸柱扣合夾緊,並令該鉗口部的單向齒與該軸柱上的單向齒相嚙合。 The invention further provides a method for operating a combination of an implant device and an interbody fusion cage, comprising: providing an interbody fusion cage, the intervertebral fusion device having a shaft column, and having a plurality of one-way teeth on the outer circumference of the shaft column; An implant device is provided, the implant device mainly comprises a clamping rod and a sliding sleeve, wherein the lower end portion of the clamping rod has two elastic clamping arms, and the outer side of the two elastic clamping arms respectively has a slope extending from the inside to the outside, And the inside of the end of the two elastic clip arms The sides are respectively provided with symmetrical C-shaped crotch portions to jointly form a jaw portion, and a plurality of one-way teeth are arranged on at least one C-shaped crotch portion, and the sliding sleeve can be sleeved on the clamping rod So that the lower end edge of the sliding sleeve can be looped around the outer inclined surface of the two elastic clamping arms, and the jaw portion of the clamping rod is exposed outside the lower end edge of the sliding sleeve; and the combination is An interbody cage and an implant device, the jaw portion of the implant device is fastened to the shaft post of the interbody cage, and the lower end edge of the sliding sleeve is moved to abut the outer slope of the two elastic clip arms. The jaw portion is configured to clamp the shaft of the interbody cage, and the one-way teeth of the jaw portion are engaged with the one-way teeth on the shaft column.

特別是,該操作方法還包含一變更植入器械與椎間融合器之間的夾持角度之操作步驟:在該植入器械與椎間融合器扣合夾緊的情況下,以該鉗口部與軸柱的夾持組合部位為中心點,將該植入器械的夾桿或椎間融合器之一或二者依前述中心點作旋轉位移一角度,如此一來,在該鉗口部夾合軸柱狀態下,藉由該二彈性夾臂具有的彈力應變特性,該鉗口部的單向齒可順向的位移以脫離與該軸柱上原先嚙合的單向齒,並嚙合到該軸柱上的其他相鄰位置上的單向齒,因此可順著單向齒的設置方向變換該植入器械與椎間融合器之間的夾持角度。 In particular, the method of operation further includes the step of changing the angle of clamping between the implant device and the interbody cage: in the case of the implant device and the interbody cage being clamped and clamped, the jaw is used The clamping portion of the portion and the shaft column is a center point, and one or both of the clamping rod or the interbody cage of the implant device are rotationally displaced by an angle according to the center point, and thus, in the jaw portion In the state of clamping the shaft column, by the elastic strain characteristic of the two elastic clamping arms, the one-way tooth of the jaw portion can be displaced in a forward direction to disengage from the one-way tooth originally engaged with the shaft column, and meshed to The one-way teeth at other adjacent positions on the shaft column can thus change the clamping angle between the implant device and the interbody cage along the direction in which the one-way teeth are disposed.

特別是,該操作方法更包含一釋放植入器械與椎間融合器之間的夾持組合之操作步驟:移動該滑套,使該滑套的下端緣套口位移離開該二彈性夾臂的外側斜面,藉由二彈性夾臂的彈性回復力量作用使該鉗口部呈開啟狀態,該鉗口部釋放對該軸柱的夾持,因此該植入器械即可與該椎間融合器相互分離。 In particular, the method of operation further includes the step of releasing a clamping combination between the implant device and the interbody cage: moving the sliding sleeve to displace the lower end edge of the sliding sleeve away from the two elastic clamping arms The outer inclined surface is opened by the elastic restoring force of the two elastic clamping arms, and the jaw portion releases the clamping of the shaft column, so that the implant device can interact with the interbody cage Separation.

此將於下文中進一步闡明本發明的其他功能及技術特徵,熟習本技術者熟讀文中的說明後即可據以實現本發明。 Other functional and technical features of the present invention will be further clarified below, and the present invention can be implemented by those skilled in the art after reading the description in the text.

100‧‧‧椎間融合器 100‧‧‧ interbody fusion cage

121‧‧‧上墊板 121‧‧‧Upper board

122‧‧‧下墊板 122‧‧‧Under the board

121a、122a‧‧‧止滑構造 121a, 122a‧‧‧ slip-slip structure

123‧‧‧立部 123‧‧‧

124‧‧‧導引頭 124‧‧‧ seeker

124a‧‧‧弧面 124a‧‧‧ curved surface

124b、124c‧‧‧斜面 124b, 124c‧‧‧ bevel

125‧‧‧開口 125‧‧‧ openings

126‧‧‧軸柱 126‧‧‧ shaft column

127‧‧‧棘齒 127‧‧‧ ratchet

150‧‧‧定位標靶 150‧‧‧Targeting target

200‧‧‧植入器械 200‧‧‧ implanted instruments

210‧‧‧握把 210‧‧‧ grip

220‧‧‧夾桿 220‧‧‧ pinch

221‧‧‧螺紋段 221‧‧ Thread segment

222‧‧‧長溝槽 222‧‧‧Long groove

223‧‧‧彈性夾臂 223‧‧‧Flexible clamp arm

224‧‧‧斜面 224‧‧‧Bevel

225‧‧‧鉗口部 225‧‧ ‧ jaws

226‧‧‧棘齒 226‧‧‧ ratchet

230‧‧‧滑套 230‧‧‧Sleeve

231‧‧‧調整螺帽 231‧‧‧ Adjusting nuts

232‧‧‧下端緣套口 232‧‧‧Bottom edge socket

300‧‧‧中空導管 300‧‧‧ hollow catheter

D‧‧‧椎間盤 D‧‧‧ Intervertebral disc

D1‧‧‧側牆 D1‧‧‧ Side wall

V‧‧‧椎骨 V‧‧‧ vertebrae

N‧‧‧神經 N‧‧‧ nerve

F‧‧‧力矩 F‧‧‧ torque

X1‧‧‧長向中心軸線 X1‧‧‧ long axis axis

X2‧‧‧中心軸線 X2‧‧‧ central axis

δ‧‧‧夾角 Δ‧‧‧ angle

圖1A是本發明實施例的椎間融合器之立體圖。 1A is a perspective view of an interbody cage of an embodiment of the present invention.

圖1B是本發明實施例的椎間融合器之另一視角的立體圖。 Fig. 1B is a perspective view of another perspective view of the interbody cage of the embodiment of the present invention.

圖1C是本發明實施例的椎間融合器之另一視角的立體圖。 1C is a perspective view of another perspective view of the interbody cage of the embodiment of the present invention.

圖1D是本發明實施例的椎間融合器之俯視圖。 Figure 1D is a top plan view of an interbody cage of an embodiment of the present invention.

圖1E是本發明實施例的椎間融合器之部分剖面的俯視圖。 Fig. 1E is a plan view showing a partial cross section of the interbody cage of the embodiment of the present invention.

圖1F是本發明實施例的椎間融合器之側視圖。 Figure 1F is a side elevational view of an interbody cage of an embodiment of the present invention.

圖2A是本發明實施例的植入器械之爆炸圖。 2A is an exploded view of an implant device in accordance with an embodiment of the present invention.

圖2B是本發明實施例的植入器械之外觀圖。 2B is an external view of an implant device in accordance with an embodiment of the present invention.

圖2C是本發明實施例的植入器械鉗口部的部分剖視圖。 2C is a partial cross-sectional view of the jaw portion of the implant device of the embodiment of the present invention.

圖3A是本發明實施例的植入器械鉗口部的特寫放大圖,顯示植入器械與椎間融合器開始組合的操作示意圖。 3A is a close-up enlarged view of the jaw portion of the implant device of the embodiment of the present invention showing the operational combination of the implant device and the intervertebral cage.

圖3B是本發明實施例的植入器械與椎間融合器組合完成的平面圖,顯示植入器械夾合椎間融合器在同一軸線上。 3B is a plan view showing the combination of the implant device and the interbody cage of the embodiment of the present invention, showing that the implant device clamps the interbody cage on the same axis.

圖3C是本發明實施例的植入器械鉗口部的特寫放大圖,顯示植入器械與椎間融合器組合完成的狀態示意圖。 3C is a close-up enlarged view of the jaw portion of the implant device of the embodiment of the present invention, showing a state in which the implant device and the interbody fusion cage are combined.

圖3D是本發明實施例的植入器械與椎間融合器變更夾持角度組合的平面圖,顯示植入器械夾合椎間融合器的軸線形成一夾角。 3D is a plan view showing a combination of an implant device and an intervertebral cage changing the clamping angle according to an embodiment of the present invention, showing that the axis of the implant device clamps the interbody cage forms an angle.

圖3E是本發明實施例的植入器械鉗口部的特寫放大圖,顯示植入器械與椎間融合器的組合形成一夾角的狀態示意圖。 3E is a close-up enlarged view of the jaw portion of the implant device of the embodiment of the present invention, showing a state in which the combination of the implant device and the interbody cage forms an angle.

圖3F是本發明實施例的植入器械鉗口部的特寫放大圖,顯示植入器械與椎間融合器的組合形成一最大夾角的狀態示意圖。 3F is a close-up enlarged view of the jaw portion of the implant device of the embodiment of the present invention, showing a state in which the combination of the implant device and the interbody cage forms a maximum angle.

圖4A是顯示一具有故障部位的脊椎結構的側視示意圖。 4A is a side elevational view showing a spinal structure having a faulty portion.

圖4B是本發明實施例以植入器械將椎間融合器植入椎間盤內的操作示意圖。 4B is a schematic illustration of the operation of implanting an interbody cage into an intervertebral disc with an implant device in accordance with an embodiment of the present invention.

圖4C是本發明實施例以植入器械將椎間融合器植入椎間盤內,並且變換夾持角度的操作示意圖。 4C is a schematic view showing the operation of implanting an interbody cage into an intervertebral disc with an implant device and changing the clamping angle according to an embodiment of the present invention.

圖4D是本發明實施例已經將椎間融合器安裝在椎間盤內部的示意圖。 Figure 4D is a schematic illustration of the embodiment of the present invention having the interbody cage mounted within the intervertebral disc.

後附的圖1A~1F詳示本發明實施例的椎間融合器100,圖2A~2C詳示本發明實施例的植入器械200,圖3A~3F詳示本發明實施例的植入器械200與椎間融合器100的組合方式,以及圖4A~4D詳示本發明實施例應用植入器械200植入椎間融合器100於相鄰之兩個椎骨之間的操作方法。 1A to 1F, the interbody cage 100 of the embodiment of the present invention is detailed, and FIGS. 2A to 2C show the implant device 200 of the embodiment of the present invention. FIGS. 3A to 3F show the implant device of the embodiment of the present invention in detail. The combination of 200 and interbody cage 100, and FIGS. 4A-4D detail the method of operation of implanting intervertebral cage 100 between adjacent vertebrae using implant device 200 in accordance with an embodiment of the present invention.

請參照第1A~1F圖,椎間融合器100用以植入於相鄰的兩個椎骨之間以重建椎間高度。該椎間融合器100的主體包含一上墊板121以及一下墊板122,上墊板121與下墊板122之間保持間隙,並由複數立部123連結成一籠型體;籠型體的構造特徵除了減輕重量、節省製造材料成本之外,籠型體的空洞內可提供生成新骨的空間,增進上、下椎骨的固定效果。 Referring to Figures 1A-1F, the interbody cage 100 is implanted between adjacent vertebrae to reconstruct the intervertebral height. The main body of the interbody cage 100 includes an upper pad 121 and a lower pad 122. The upper pad 121 and the lower pad 122 maintain a gap therebetween, and are connected by a plurality of vertical portions 123 into a cage; the cage body In addition to reducing the weight and saving the cost of manufacturing materials, the structural features of the cage can provide space for new bone formation and enhance the fixation of the upper and lower vertebrae.

椎間融合器為了保持優良的機械強度和抗化學性,並且避免植入人體內產生排斥,使用的材料是選自於可吸收性高分子材料、不 可吸收性高分子材料、金屬、陶瓷、骨材或前述材料二者以上的組合所製成,但實施範圍並不以此為限,舉例來說,可吸收性高分子材料可例如是聚乳酸-羥基乙酸共聚物(poly(lactic-co-glycolic acid),PLGA)或聚左乳酸(Poly-L-Lactic Acid,PLLA),不可吸收性高分子可例如是聚醚醚酮(Polyetheretherketone,PEEK),金屬可例如是鈦或不鏽鋼,骨材可例如是來自於人體或其他的動物。 In order to maintain excellent mechanical strength and chemical resistance, and to avoid repulsion in the human body, the intervertebral cage is selected from absorbable polymer materials, not The absorbable polymer material, the metal, the ceramic, the aggregate or a combination of the above materials is used, but the scope of implementation is not limited thereto. For example, the absorbable polymer material may be, for example, polylactic acid. - Poly(lactic-co-glycolic acid, PLGA) or Poly-L-Lactic Acid (PLLA), the non-absorbable polymer may be, for example, polyetheretherketone (PEEK). The metal may be, for example, titanium or stainless steel, and the aggregate may be, for example, from a human body or other animal.

另,在椎間融合器的上墊板121與下墊板122之向外側的表面上設有止滑構造121a、122a,該止滑構造例如是由多數鋸齒狀條紋或凹凸狀的壓花圖案所構成的,止滑構造可增加該椎間融合器100安裝在椎骨之間的定位穩定性,避免安裝後位置偏移造成手術失敗的後果。 Further, on the outer surface of the upper pad 121 and the lower pad 122 of the interbody cage, the anti-slip structures 121a and 122a are provided, and the anti-slip structure is, for example, an embossed pattern of a plurality of zigzag stripes or irregularities. The anti-slip configuration can increase the positioning stability of the interbody cage 100 between the vertebrae, and avoid the consequences of surgical failure caused by the positional displacement after installation.

如所知的,椎間融合器100的形狀及尺寸規格可依據患者之需求決定,但它的形狀必須相應於安裝部位的結構形狀,例如,當它被安裝在椎骨前緣或是後緣部位時,通常其主體外型係呈一豌豆形狀或新月形狀(參見圖1D),這樣椎間融合器100具有足夠接觸面以承擔椎骨間的壓力,而且這種椎間融合器具有長形主體,亦即主體的長軸尺寸是大於寬軸尺寸的,這是有利於微創手術的植入操作,讓椎間融合器可由最小尺寸部位(即寬軸部位)通過導管進入安裝部位,以便於縮小手術傷口。 As is known, the shape and size of the interbody cage 100 can be determined according to the needs of the patient, but its shape must correspond to the structural shape of the mounting site, for example, when it is mounted on the leading or trailing edge of the vertebra. In general, the body appearance is in the shape of a pea or a crescent (see Fig. 1D), such that the interbody cage 100 has sufficient contact surface to bear the pressure between the vertebrae, and the interbody cage has an elongated body. That is, the long axis dimension of the main body is larger than the width of the wide axis, which is an implantation operation for facilitating minimally invasive surgery, and the interbody cage can be accessed from the smallest size portion (ie, the wide shaft portion) through the catheter into the installation site, so as to facilitate Reduce the surgical wound.

於本實施例中,在椎間融合器主體的長向中心軸線X1之前端具一流線型的導引頭124,以及在主體的長向中心軸線X1的後端面上設有一開口125,於該開口內具一立向設置的軸柱126,且於軸柱外周緣設有複數個單向齒,例如是棘齒127,該等單向齒可設置 在軸柱的整個外周緣,或是只有在軸柱外周緣的一部分,例如在本實施例中,只在軸柱外周緣的一側約90度的範圍設置數個棘齒127。主體之導引頭124可幫助椎間融合器100的順利植入,並且可確保植入過程的安全性;如圖1E所示,引導頭124設於椎間融合器主體的長向中心軸線X1的前端緣,該引導頭由一連接主體二側牆之間的弧面124a,以及分別自上墊板與下墊板向中間延伸的二斜面124b、124c,共同構成一立體的流線型構造。 In the present embodiment, a first-line guide vane 124 is provided at the front end of the longitudinal center axis X1 of the interbody cage body, and an opening 125 is provided on the rear end surface of the longitudinal center axis X1 of the main body. The shaft column 126 is disposed in an upright direction, and a plurality of one-way teeth are disposed on the outer circumference of the shaft column, such as ratchet teeth 127, and the one-way teeth can be set At the entire outer circumference of the shaft column, or only a part of the outer circumference of the shaft column, for example, in the present embodiment, a plurality of ratchet teeth 127 are provided only in a range of about 90 degrees on one side of the outer circumference of the shaft column. The body of the seeker 124 can facilitate the smooth implantation of the interbody fusion cage 100 and ensure the safety of the implantation process; as shown in Figure 1E, the guide head 124 is disposed on the long central axis X1 of the interbody cage body. The front end edge of the guiding head is formed by a curved surface 124a between the side walls of the connecting main body and two inclined surfaces 124b and 124c extending from the upper backing plate and the lower backing plate respectively to form a three-dimensional streamlined structure.

一般來說,當開創一個微型傷口來移除椎間盤時,椎間盤往往無法完全地移除而可能殘留部份的椎間盤;因此,當將椎間融合器100植入到兩個椎骨間的過程中,殘留的椎間盤可能會增加植入物體時的阻力;由於本實施例之椎間融合器100的植入端具有流線型的導引頭124,因此在植入過程中可輕易剝開椎間盤之環狀纖維且有效地降低殘留的椎間盤所形成的阻力,並將該椎間融合器100準確引導至所欲的安裝位置。在另一方面,在導引頭124前端的流線型構造,可避免椎間融合器100於植入過程中推進時產生偏移,以及防止銳利的尖端刮傷或刺穿週邊神經或組織造成傷害,達椎間融合器100安全植入之目的;換言之,本發明實施例可大幅提昇植入椎間融合器100手術操作的簡易性及安全性。 In general, when a micro-wound is created to remove the intervertebral disc, the intervertebral disc is often unable to be completely removed and a portion of the intervertebral disc may remain; therefore, when the interbody cage 100 is implanted between the two vertebrae, The residual intervertebral disc may increase the resistance when the implant is implanted; since the implant end of the interbody fusion cage 100 of the present embodiment has a streamlined seeker 124, the annular fiber of the intervertebral disc can be easily peeled off during the implantation process. And effectively reducing the resistance formed by the residual intervertebral disc and accurately guiding the interbody cage 100 to the desired mounting position. In another aspect, the streamlined configuration at the front end of the seeker 124 prevents the intervertebral cage 100 from shifting as it advances during implantation, and prevents sharp tips from scratching or piercing peripheral nerves or tissue, The purpose of safely implanting the interbody fusion cage 100; in other words, the embodiment of the present invention can greatly improve the ease and safety of the surgical operation of the interbody fusion cage 100.

再請參閱圖1A與1E所示,於本實施例中,椎間融合器100更包括至少二個定位標靶150以彼此分隔儘量遠離的設置於主體上。該等定位標靶150可以是一個鏤空部、或是採用與本體相異材質的材料所製成的物體,例如,當椎間融合器的本體是使用鈦金屬材料,而該定位標靶150可以是圓孔狀或是其他任意幾何形狀的鏤空部,或是椎間融合器的本體是使用高分子材料,而該定位標靶 150可以是使用鈦金屬材料製成的圓柱體;據此當椎間融合器100植入體內的過程中,可利用標靶掃描裝置,例如是手術用X光機(C-arm),擷取椎間融合器100上的定位標靶150的位置及角度參數,以便即時性的確認椎間融合器100的植入體內的位置及置放角度。 Referring to FIG. 1A and FIG. 1E , in the embodiment, the interbody cage 100 further includes at least two positioning targets 150 disposed on the main body so as to be separated from each other as far as possible. The positioning target 150 may be a hollow portion or an object made of a material different from the body. For example, when the body of the interbody cage is made of titanium metal, the positioning target 150 may be a hollow hole or any other geometrically shaped hollow portion, or the body of the interbody cage is a polymer material, and the positioning target 150 may be a cylinder made of a titanium metal material; accordingly, when the interbody cage 100 is implanted in the body, a target scanning device such as a surgical X-ray machine (C-arm) may be used. The position and angle parameters of the target 150 on the interbody cage 100 are used to immediately confirm the position and placement angle of the implant of the interbody cage 100.

圖2A~2C繪示一較佳實施例之植入器械200的構造,它可用以夾持前揭實施例所述的椎間融合器100並將其植入相鄰之二椎骨之間;該植入器械200主要包含一握把210、一夾桿220以及一滑套230。 2A-2C illustrate a configuration of an implant device 200 of a preferred embodiment for clamping the interbody cage 100 of the prior embodiment and implanting it between adjacent vertebrae; The implant device 200 mainly includes a grip 210, a clamping bar 220 and a sliding sleeve 230.

夾桿220的上端部位與握把210樞接組合成一體,在夾桿中段部位設有螺紋段221,而夾桿220的下端部位具一長溝槽222以界定出二彈性夾臂223,在二彈性夾臂223的外側分別設有由內向外漸擴的斜面224,而二彈性夾臂末端的內側分別設有相對稱的C字型的顎部以共同構成一鉗口部225,並在至少一C字型顎部上設有複數個單向齒,例如是棘齒226,該等棘齒226恰可與前述椎間融合器軸柱126上的棘齒127彼此嚙合。 The upper end portion of the clamping rod 220 is pivotally combined with the grip 210, and a threaded portion 221 is disposed at a middle portion of the clamping rod, and a lower end portion of the clamping rod 220 has a long groove 222 to define two elastic clamping arms 223. The outer side of the elastic clamping arm 223 is respectively provided with a slope 224 which is gradually enlarged from the inside to the outside, and the inner side of the end of the two elastic clamping arms are respectively provided with symmetrical C-shaped jaws to jointly form a jaw portion 225, and at least A C-shaped crotch portion is provided with a plurality of one-way teeth, such as ratchet teeth 226, which are intermeshing with the ratchet teeth 127 on the aforementioned interbody cage shaft post 126.

另在滑套230上端設有一調整螺帽231,而滑套230可串套在夾桿220上,使調整螺帽231可螺接於夾桿的螺紋段221上,滑套的下端緣套口232可環套於二彈性夾臂223的外側斜面224附近,使夾桿的鉗口部225部位敞露於滑套的下端緣套口232之外。 In addition, an adjusting nut 231 is disposed on the upper end of the sliding sleeve 230, and the sliding sleeve 230 can be sleeved on the clamping rod 220, so that the adjusting nut 231 can be screwed onto the threaded section 221 of the clamping rod, and the lower end edge of the sliding sleeve is sleeved. The 232 can be looped around the outer bevel 224 of the two elastic clamping arms 223 such that the jaw portion 225 of the clamping bar is exposed outside the lower end edge of the sliding sleeve 232.

依上述描述的植入器械200構造,當滑套上的調整螺帽231轉動時,夾桿220相對於滑套230做軸向移動,使得滑套的下端緣套口232與二彈性夾臂的外側斜面224的作用位置改變,據此操控鉗口部225的閉合或開啟。 According to the implant device 200 described above, when the adjusting nut 231 on the sliding sleeve rotates, the clamping rod 220 moves axially relative to the sliding sleeve 230, so that the lower end edge of the sliding sleeve 232 and the two elastic clamping arms The position of the outer bevel 224 changes, thereby controlling the closing or opening of the jaw portion 225.

以下將配合圖3A~3F進一步說明,植入器械200與椎間融合器100的夾合與釋放的操作方法。 The method of operation of clamping and releasing the implant device 200 with the interbody cage 100 will be further described below in conjunction with FIGS. 3A-3F.

請參照圖3A~3C顯示植入器械200與椎間融合器100夾合操作的示意圖,首先於植入器械的鉗口部224呈張開狀態下,將植入器械的二彈性夾臂223前端部通過椎間融合器的開口125深入主體內,使鉗口部225扣接於軸柱上,然後轉動調整螺帽231使滑套230向夾桿220下端位移,滑套的下端緣套口232抵頂二彈性夾臂的外側斜面224,使二彈性夾臂223的C字型顎部向內側彼此靠近,鉗口部225逐漸閉合因此將椎間融合器的軸柱126扣合夾緊。反之,使滑套230向夾桿220上端位移,滑套的下端緣套口232脫離抵頂二彈性夾臂的外側斜面224,二彈性夾臂夾臂藉由彈力回復原位,使鉗口部225呈全開狀態,鉗口部225釋放對軸柱126的夾持,植入器械200即可與椎間融合器100分離。前述使鉗口部225對軸柱126的夾持、釋放之操作均可透過滑套上的調整螺帽231操控,因此可提升手術操作的簡易性,及對植入器械200操控的穩定性。 3A-3C show a schematic view of the operation of the implant device 200 and the interbody cage 100. First, the front end of the two elastic clip arms 223 of the implanted instrument is opened in the jaw portion 224 of the implant device. The portion penetrates into the main body through the opening 125 of the interbody cage, and the jaw portion 225 is fastened to the shaft post, and then the adjusting nut 231 is rotated to displace the sliding sleeve 230 toward the lower end of the clamping rod 220, and the lower end edge of the sliding sleeve is 232. The outer inclined surface 224 of the two elastic clamping arms abuts the C-shaped crotch portion of the two elastic clamping arms 223 toward the inner side, and the jaw portion 225 is gradually closed, thereby clamping and clamping the shaft column 126 of the interbody cage. Conversely, the sliding sleeve 230 is displaced toward the upper end of the clamping rod 220, and the lower end edge sleeve 232 of the sliding sleeve is disengaged from the outer inclined surface 224 of the top elastic clamping arm, and the two elastic clamping arm clamping arms are returned to the original position by the elastic force, so that the jaw portion is The 225 is fully open, the jaw portion 225 releases the clamping of the shaft post 126, and the implant device 200 can be separated from the interbody cage 100. The operation of clamping and releasing the jaw portion 225 to the shaft post 126 can be controlled by the adjusting nut 231 on the sliding sleeve, thereby improving the ease of the surgical operation and the stability of the manipulation of the implant device 200.

另在圖3D~3F進一步繪示變更植入器械200與椎間融合器100之間的夾持角度之操作方式;本發明藉由二彈性夾臂223具有彈力應變特性,可在植入器械與椎間融合器夾合的情況下,直接進行操作以變更二者之間的夾持角度,亦即以鉗口部225與軸柱126的夾持組合部位為中心點,將植入器械的夾桿220或椎間融合器100的本體之一或二者依該中心點作擺動位移,使植入器械的夾桿220相對於椎間融合器的軸柱126轉擺一角度。這種便利且快速的操作方式是可行的,例如按照圖3B、3D所繪示的,操作時,在椎間融合器100的本體固定不動的情況下,植入器械的夾桿220以鉗口 部225與軸柱126的夾持組合部位為中心作順時鐘方向轉擺一角度,此時,鉗口部225與軸柱126雖然處於夾合狀態下,但藉由二彈性夾臂223具有的彈力應變特性,鉗口部225的棘齒226仍可順向的位移以脫離與軸柱126上原先嚙合的棘齒127,並嚙合到軸柱126上的其他相鄰位置上的棘齒(如圖3E所示);而重複前述操作可使植入器械與椎間融合器的組合形成一最大夾角(如圖3F所示)。 The operation mode of changing the clamping angle between the implant device 200 and the interbody cage 100 is further illustrated in FIGS. 3D to 3F; the present invention has elastic strain characteristics by the two elastic clamp arms 223, and can be implanted in the device. In the case where the interbody cage is clamped, the operation is directly performed to change the clamping angle between the two, that is, the clamping point of the jaw portion 225 and the shaft post 126 is centered, and the clip of the implanted instrument is placed. One or both of the rods 220 or the body of the interbody cage 100 are oscillatingly displaced about the center point such that the clamping bar 220 of the implant device is angled relative to the shaft post 126 of the interbody cage. This convenient and fast mode of operation is possible, for example, as illustrated in Figures 3B, 3D, in operation, with the body of the interbody cage 100 immobilized, the clamping bar 220 of the implant device is clamped The clamping portion of the portion 225 and the shaft post 126 is pivoted at an angle from the center. At this time, the jaw portion 225 and the shaft post 126 are in a sandwiched state, but are provided by the two elastic clamping arms 223. The elastic strain characteristic, the ratchet teeth 226 of the jaw portion 225 can still be displaced in a forward direction to disengage the ratchet teeth 127 originally engaged with the shaft post 126 and engage the ratchet teeth at other adjacent positions on the shaft post 126 (eg, Figure 3E); and repeating the foregoing operation allows the combination of the implant device and the interbody cage to form a maximum angle (as shown in Figure 3F).

上述操作方法,可在植入器械與椎間融合器呈夾緊組合的情況下直接進行操作變更二者之間的夾持角度,因此使得植入器械200與椎間融合器100的夾持角度變更成為非常容易,操作方式也極為快速;更特別的是,這種夾持角度變更的操作可在極小的活動空間內執行及完成,因此非常適合在微創手術中應用。但從另一方面來說,上述變更夾持角度的操作過程中,也可以在適度的放鬆鉗口部225對軸柱126的夾持情況下進行,如此一來,可更省力、更容易的操作鉗口部的棘齒226與軸柱棘齒127之嚙合轉換。 In the above operation method, the clamping angle between the implant device and the interbody cage 100 can be directly changed when the implant device and the interbody cage are in a clamping combination, thereby making the clamping angle between the implant device 200 and the interbody cage 100. The change is very easy and the operation is extremely fast; more specifically, this change in clamping angle can be performed and completed in a very small active space, making it ideal for use in minimally invasive surgery. However, on the other hand, during the operation of changing the clamping angle, the clamping of the shaft post 126 can be performed under the moderate relaxation of the jaw portion 225, so that it can be more labor-saving and easier. The engagement of the ratchet teeth 226 of the jaw portion with the shaft ratchet teeth 127 is converted.

在圖4A~4D繪示了應用植入器械200來植入椎間融合器100之操作方法與實施步驟。 4A-4D illustrate the method of operation and implementation steps of implanting the interbody cage 100 using the implant device 200.

如圖4A顯示一處故障的脊椎結構示意圖,患者之相鄰的兩個椎骨V間的椎間盤D的一部分係因退化或脫出而壓迫到神經N,治療的方式會以外科手術來進行移除故障的組織,例如是碎骨片、椎間盤D,並以內固定器及椎間骨融合器100來重建兩個椎骨V間的高度,以穩定術後的脊椎。 Figure 4A shows a schematic diagram of a broken spinal structure. A portion of the intervertebral disc D between two adjacent vertebrae V of the patient is compressed into the nerve N due to degeneration or prolapse. The treatment is surgically removed. The failed tissue, such as the broken bone piece, the intervertebral disc D, and the height between the two vertebrae V is reconstructed with the internal fixator and the interbody fusion cage 100 to stabilize the postoperative spine.

在圖4B~4D圖顯示一種使用微創手術進行治療的方式;一中空導管300係被安裝在於鄰近椎間盤D處之椎骨V的一側,並以經椎間 孔椎體融合術(Transforaminal Lumbar Interbody Fusion,TLIF)的方式將椎間融合器100植入因椎間盤D切除術所造成的空洞。進行治療時,先利用如圖3A~3C中所述的操作方式來組合植入器械200與椎間融合器100,亦即,將植入器械的鉗口部225穿過椎間融合器的開口125而扣接在軸柱126上,然後轉動調整螺帽231使滑套下端緣套口232抵頂二彈性夾臂的外側斜面224,令鉗口部225與軸柱126扣合夾緊,並使植入器械的夾桿220之中心軸線X2與椎間融合器的長向中心軸線X1二者重合在同一軸線方向上,據此可讓植入器械200所夾持椎間融合器100順利地通過狹窄的中空導管300被推送至椎間盤D內。 4B to 4D show a method of treatment using minimally invasive surgery; a hollow catheter 300 is mounted on the side of the vertebra V adjacent to the intervertebral disc D, and is intervertebral Transforaminal Lumbar Interbody Fusion (TLIF) is used to implant the cage 160 into a cavity caused by discectomy. When performing the treatment, the implant device 200 and the interbody cage 100 are first combined using the operation modes as described in FIGS. 3A-3C, that is, the jaw portion 225 of the implant device is passed through the opening of the interbody cage. 125 is fastened to the shaft post 126, and then the adjusting nut 231 is rotated so that the lower end edge of the sliding sleeve 232 abuts against the outer inclined surface 224 of the two elastic clamping arms, so that the jaw portion 225 is fastened and clamped with the shaft post 126, and The central axis X2 of the clamping rod 220 of the implant device and the long central axis X1 of the interbody cage are coincident in the same axial direction, thereby allowing the intervertebral cage 100 clamped by the implant device 200 to be smoothly It is pushed into the intervertebral disc D through the narrow hollow catheter 300.

手術進行中,當植入器械200將椎間融合器100推送到中空導管300底部時,可能會遭遇植入部位附近的殘留組織所引起的阻力,例如殘留的椎間盤D,可對植入器械的握把210頂緣施力敲擊,使植入器械200夾持該椎間融合器100沿著施力方向移動推進排除阻礙,從而順利的將椎間融合器100推送進入椎間盤D內,且可避免在椎間融合器的移動推進過程中產生路徑偏移,傷及附近的神經與周圍組織。 During the operation, when the implant device 200 pushes the interbody cage 100 to the bottom of the hollow catheter 300, it may encounter resistance caused by residual tissue near the implantation site, such as residual disc D, which can be applied to the implanted device. The top edge of the grip 210 is struck by force, so that the implant device 200 holds the intervertebral cage 100 to move along the direction of the force application to advance the obstruction, thereby smoothly pushing the interbody cage 100 into the intervertebral disc D, and Avoid path deviation during the movement of the interbody cage, and injure nearby nerves and surrounding tissues.

在圖4C中顯示植入過程中更換夾具與椎間融合器100的夾持角度的情況;當椎間融合器100推送進入椎間盤D內,持續位移前進的椎間融合器的引導頭124接觸或接近椎間盤D的側牆D1時,需變換椎間融合器100的植入推進角度,以便後續的推進位移;其中,變更椎間融合器100擺置角度的夾持操作方式已在圖3D、3F詳細述明;操作時,以鉗口部225與軸柱126的夾持組合部位為中心,將植入器械的夾桿220向左側方微微轉擺,使植入器械的中心 軸線X2與椎間融合器的長向中心軸線X1之間形成一小的夾角δ,然後再對植入器械的握把210頂緣輕敲施力,持續向前推進椎間融合器100,此時,引導頭124受側牆D1的阻力而在長向中心軸線X1上產生一逆時針方向的力矩F,藉由該力矩F的作用,使得在椎間融合器100的本體向前位移推進過程中,前述夾角δ的角度被逐漸擴大,同時地,鉗口部的棘齒226可順向的位移以脫離與軸柱上原先嚙合的棘齒,並重新嚙合到下一相鄰位置的棘齒127上,因此變換植入器械200與椎間融合器100之間的夾持角度;經重複前述變換夾持角度與施力推進之操作步驟,直到最終可將椎間融合器100妥適地安裝於椎骨V邊緣的主要受力區域,也就是位於椎間盤D的側牆D1內側附近。由於本實施例之椎間融合器100的輪廓形狀係接近椎間盤D的側牆D1形狀,且植入後的最終位置亦在椎骨V的主要受力區域,因此,椎間融合器100可在受力均勻的情況下承擔椎骨間的壓力,故可有效提供支撐的作用。 The clamping angle of the replacement clamp and the interbody cage 100 during implantation is shown in FIG. 4C; when the interbody cage 100 is pushed into the intervertebral disc D, the guide head 124 of the interbody cage that continues to displace is contacted or When approaching the side wall D1 of the intervertebral disc D, it is necessary to change the implantation advancement angle of the interbody cage 100 for subsequent advancement displacement; wherein the clamping operation mode for changing the placement angle of the interbody cage 100 is shown in Figs. 3D and 3F. Specifically, in operation, centering on the clamping combination portion of the jaw portion 225 and the shaft post 126, the clamping rod 220 of the implanted instrument is slightly turned to the left side to make the center of the implanted device A small angle δ is formed between the axis X2 and the long central axis X1 of the interbody cage, and then the top edge of the grip 210 of the implant device is tapped to continuously advance the interbody cage 100. When the guide head 124 is subjected to the resistance of the side wall D1 and generates a counterclockwise moment F on the long central axis X1, the body of the interbody cage 100 is displaced forward by the action of the moment F. The angle of the aforementioned angle δ is gradually enlarged, and at the same time, the ratchet teeth 226 of the jaw portion are displaced in the forward direction to disengage the ratchet teeth originally engaged with the shaft column, and re-engage to the ratchet teeth of the next adjacent position. 127, thus changing the clamping angle between the implant device 200 and the interbody cage 100; repeating the aforementioned steps of changing the clamping angle and applying the force until the interbody cage 100 can be properly installed. The main area of force of the vertebra V edge, that is, the inner side of the side wall D1 of the intervertebral disc D. Since the contour shape of the interbody cage 100 of the present embodiment is close to the shape of the side wall D1 of the intervertebral disc D, and the final position after implantation is also in the main force region of the vertebra V, the interbody cage 100 can be subjected to When the force is uniform, the pressure between the vertebrae is taken, so that the support can be effectively provided.

完成椎間融合器100的安裝定位後,將滑套230向夾桿220上端位移,使鉗口部225呈開啟狀態,鉗口部225釋放對軸柱126的夾持,植入器械200即可與椎間融合器100分離然後取出。 After the positioning and positioning of the interbody cage 100 is completed, the sliding sleeve 230 is displaced toward the upper end of the clamping rod 220, so that the jaw portion 225 is opened, and the jaw portion 225 releases the clamping of the shaft column 126, and the instrument 200 can be implanted. It is separated from the interbody cage 100 and then taken out.

藉由上述植入操作方法,椎間融合器100可通過一個狹小管道置入體內,植入器械200亦可在該狹小空間範圍內操作,使椎間融合器100位移推進及變更擺置角度,以便安裝到椎間盤D內的正確位置;因此,植入過程僅需在患者身上開創一個小於3公分的微型傷口,所以患者在手術過程中可避免大傷口可能造成的大量失血的風險,並且防止對脊椎之周圍組織或神經的損傷;還有更進一步的優點是,患者於術後復原的時間可縮短,且可避免例如 是下背無力或疼痛的後遺症。 By the above-mentioned implantation operation method, the interbody cage 100 can be placed into the body through a narrow tube, and the implant device 200 can also operate in the narrow space to make the interbody cage 100 displace and advance the angle of the placement. In order to be installed in the correct position in the disc D; therefore, the implantation process only needs to create a micro-wound of less than 3 cm in the patient, so the patient can avoid the risk of massive blood loss caused by the large wound during the operation, and prevent the pair Damage to the surrounding tissue or nerves of the spine; a further advantage is that the patient's time to recovery after surgery can be shortened and can be avoided, for example It is the sequela of weakness or pain in the lower back.

此外,前述植入過程中,操作的醫師可利用標靶掃描裝置,例如是手術用X光機(C-arm),擷取椎間融合器100上的定位標靶150的位置及角度參數,以提供手術過程即時性的操作參考,例如,當椎間融合器的引導頭124前端接觸前側的椎間盤的側牆D1時,即可依據相關參數判斷以便停止對植入器械200持續敲擊推進並變換夾持角度,避免敲擊前進過程鑿損椎間盤的側牆D1;除此之外,當有椎間融合器100的推進位置或擺置角度不正確時亦可藉此獲得即時性的修正。 In addition, during the aforementioned implantation process, the operating physician can utilize the target scanning device, such as a surgical X-ray machine (C-arm), to capture the position and angle parameters of the positioning target 150 on the interbody cage 100. To provide an operational reference for the immediacy of the surgical procedure, for example, when the front end of the guide head 124 of the interbody cage contacts the side wall D1 of the anterior disc, it can be judged according to relevant parameters to stop the continuous advancement of the implant device 200 and The clamping angle is changed to avoid the cutting of the side wall D1 of the intervertebral disc by the tapping process; in addition, when the advancing position or the angle of the intervertebral cage 100 is incorrect, the immediacy correction can be obtained thereby.

以上是本發明的椎間融合器及植入器械及其操作方法的具體實施方式,本發明並不局限於此,凡在本發明的技術思想和技術原則內所作的任何替換、變更、變形等均屬於本發明的保護範圍。 The above is a specific embodiment of the interbody cage and the implant device of the present invention and the method of operating the same, and the present invention is not limited thereto, and any substitutions, alterations, modifications, etc. made in the technical idea and technical principle of the present invention. All fall within the scope of protection of the present invention.

100‧‧‧椎間融合器 100‧‧‧ interbody fusion cage

126‧‧‧軸柱 126‧‧‧ shaft column

127‧‧‧棘齒 127‧‧‧ ratchet

224‧‧‧斜面 224‧‧‧Bevel

225‧‧‧鉗口部 225‧‧ ‧ jaws

226‧‧‧棘齒 226‧‧‧ ratchet

230‧‧‧滑套 230‧‧‧Sleeve

232‧‧‧下端緣套口 232‧‧‧Bottom edge socket

X1‧‧‧長向中心軸線 X1‧‧‧ long axis axis

X2‧‧‧中心軸線 X2‧‧‧ central axis

Claims (20)

一種椎間融合器,該椎間融合器用於配合一具有二彈性夾臂的植入器械,且可植入相鄰的二椎骨之間以重建椎間高度,該椎間融合器的主體包含一上墊板以及一下墊板,該上墊板與該下墊板之間保持間隙,並由複數立部連結成一籠型體;該主體的外型係呈一豌豆形狀或新月形狀,且該主體的長向尺寸大於寬向尺寸;在該主體的長向中心軸線之前端設有一流線型的導引頭,以及在該長向中心軸線的後端面設有一開口,於該開口內具一立向設置的軸柱,且於該軸柱外周緣設有複數個第一單向齒,該二彈性夾臂的至少一彈性夾臂設有複數個第二單向齒,該複數個第一單向齒與該複數個第二單向齒相嚙合,從而該二彈性夾臂通過彈力應變性改變該椎間融合器和該植入器械之间的夾持角度。 An interbody cage for fitting an implant device having two elastic clip arms and implantable between adjacent vertebrae to reconstruct an intervertebral height, the body of the interbody cage comprising a An upper pad and a lower pad, wherein the upper pad and the lower pad maintain a gap, and are connected by a plurality of vertical portions into a cage body; the body of the body has a pea shape or a crescent shape, and the body The longitudinal dimension of the main body is larger than the wide dimension; a front end of the longitudinal center axis of the main body is provided with a first-line guide head, and an opening is provided at a rear end surface of the long central axis, and a vertical direction is provided in the opening a plurality of first one-way teeth are disposed on the outer circumference of the shaft column, and at least one elastic clamping arm of the two elastic clamping arms is provided with a plurality of second one-way teeth, the plurality of first one-way teeth The teeth engage the plurality of second one-way teeth such that the two elastic clip arms change the clamping angle between the interbody cage and the implant device by elastic strain. 如申請專利範圍第1項所述之椎間融合器,其中在該上墊板與該下墊板之向外側的表面上設有止滑構造。 The interbody cage of claim 1, wherein the anti-slip structure is provided on an outer side surface of the upper pad and the lower pad. 如申請專利範圍第2項所述之椎間融合器,其中該止滑構造為多數鋸齒狀條紋或凹凸狀的壓花圖案之一。 The interbody cage of claim 2, wherein the anti-slip structure is one of a plurality of serrated stripe or embossed embossed patterns. 如申請專利範圍第1項所述之椎間融合器,其中該複數個第一單向齒和該複數個第二單向齒為棘齒。 The interbody cage of claim 1, wherein the plurality of first one-way teeth and the plurality of second one-way teeth are ratchet teeth. 如申請專利範圍第1項所述之椎間融合器,其中該複數個第一單向齒係可選擇地設置在該軸柱的整個外周緣或是只有在該軸柱外周緣的一部分。 The interbody cage of claim 1, wherein the plurality of first one-way dentitions are selectively disposed over the entire outer circumference of the shaft column or only a portion of the outer circumference of the shaft column. 如申請專利範圍第1項所述之椎間融合器,其中該引導頭是由一連接該主體二側牆之間的弧面,以及分別自該上墊板與該下墊板表面向中間延伸的二斜面,共同構成一立體的流線型構造。 The interbody cage according to claim 1, wherein the guiding head is formed by a curved surface connecting the two side walls of the main body, and extending from the upper pad and the lower pad surface respectively. The two inclined faces together form a three-dimensional streamlined structure. 如申請專利範圍第1項所述之椎間融合器,其中該椎間融合器係由一可吸 收性高分子材料、一不可吸收性高分子材料、一金屬、一陶瓷、一骨材或上述之組合所製成。 The interbody cage of claim 1, wherein the interbody cage is smokable A polymer material, a non-absorbable polymer material, a metal, a ceramic, an aggregate or a combination thereof. 如申請專利範圍第1項所述之椎間融合器,更包括至少二個定位標靶,各個定位標靶以彼此分隔儘量遠離的設置於該主體上。 The interbody cage according to claim 1, further comprising at least two positioning targets, each of the positioning targets being disposed apart from each other as far as possible from each other. 如申請專利範圍第8項所述之椎間融合器,其中該定位標靶為一設在該主體上的鏤空部。 The interbody cage of claim 8, wherein the positioning target is a hollow portion provided on the main body. 如申請專利範圍第8項所述之椎間融合器,其中該定位標靶為一設在該主體上且使用與該主體相異材質的材料所製成的物體。 The interbody cage of claim 8, wherein the positioning target is an object formed on the main body and using a material different from the main body. 一種植入器械,可用以夾持一椎間融合器並將其植入相鄰之二椎骨之間,該椎間融合器包括一軸柱,且於該軸柱外周緣設有複數個第一單向齒;該植入器械包括:一夾桿,在其下端部位具一長溝槽以界定出二彈性夾臂,在該二彈性夾臂的外側分別設有由內向外漸擴的斜面,以及該二彈性夾臂末端的內側分別設有相對稱的C字型的顎部以共同構成一鉗口部,並在至少一C字型顎部上設有複數個與該複數個第一單向齒相嚙合的第二單向齒;一握把,其與該夾桿的上端部位樞接組合成一體;以及一滑套,為一中空的筒體,其可串套在該夾桿上,該滑套的下端緣套口可環套於該二彈性夾臂的外側斜面附近,使該夾桿的鉗口部可敞露於該滑套的下端緣套口之外;藉由使該滑套相對於該夾桿作軸向移動,以改變該滑套的下端緣套口與該二彈性夾臂的外側斜面之間的相對位置,據此操控該鉗口部的閉合或開啟,從而該二彈性夾臂通過彈力應變性改變該椎間融合器和該植入器械之间的夾持角度。 An implant device for clamping an intervertebral cage and implanting it between adjacent vertebrae, the interbody cage comprising a shaft column, and a plurality of first sheets on the outer circumference of the shaft column The implant device includes: a clamping rod having a long groove at a lower end portion thereof to define two elastic clamping arms, and an inclined surface extending from the inside to the outside respectively on the outer side of the two elastic clamping arms, and the The inner sides of the ends of the two elastic clamping arms are respectively provided with symmetrical C-shaped crotch portions to jointly form a jaw portion, and a plurality of the first one-way teeth are disposed on the at least one C-shaped crotch portion a second one-way tooth that is engaged; a grip that is pivotally combined with the upper end portion of the clamping rod; and a sliding sleeve that is a hollow cylinder that can be sleeved on the clamping rod, The lower end edge of the sliding sleeve can be sleeved around the outer inclined surface of the two elastic clamping arms, so that the jaw portion of the clamping rod can be exposed outside the lower end edge of the sliding sleeve; Axial movement relative to the clamping rod to change between the lower end edge of the sliding sleeve and the outer inclined surface of the two elastic clamping arms Relative position, whereby manipulation of the jaw portion is opened or closed, so that the two elastic gripping arms gripping change the angle between the cage and the instrument through the elastic strain of the implant. 如申請專利範圍第11項所述之植入器械,其中該複數個第一單向齒和該複數個第二單向齒為棘齒。 The implant device of claim 11, wherein the plurality of first one-way teeth and the plurality of second one-way teeth are ratchet teeth. 如申請專利範圍第11項所述之植入器械,還包括於該夾桿的中段部位設有一螺紋段,以及在該滑套上設有一調整螺帽,該滑套串套在該夾桿上 時,該調整螺帽可螺接於該夾桿的螺紋段上,藉轉動該調整該螺帽可操控該夾桿與該滑套之間做軸向相對位移。 The implant device of claim 11, further comprising a threaded section at a middle portion of the clamping rod, and an adjusting nut disposed on the sliding sleeve, the sliding sleeve being sleeved on the clamping rod The adjusting nut can be screwed onto the threaded section of the clamping rod, and by rotating the adjusting nut, the axial displacement relative between the clamping rod and the sliding sleeve can be controlled. 一種植入器械與椎間融合器之組合的操作方法,包括:提供一椎間融合器,該椎間融合器具一軸柱,且於該軸柱外周緣設有複數個第一單向齒:提供一植入器械,該植入器械包含一夾桿及一滑套,該夾桿的下端部位具二彈性夾臂,在該二彈性夾臂的外側分別設有由內向外漸擴的斜面,以及二彈性夾臂末端的內側分別設有相對稱的C字型的顎部以共同構成一鉗口部,並在至少一C字型顎部上設有複數個第二單向齒,該滑套可串套在該夾桿上,使該滑套的下端緣套口可環套於該二彈性夾臂的外側斜面附近,並令該夾桿的鉗口部敞露於該滑套的下端緣套口之外;以及組合該椎間融合器與該植入器械,將該植入器械的鉗口部扣接於該椎間融合器的軸柱上,移動該滑套的下端緣套口抵頂該二彈性夾臂的外側斜面,使該鉗口部將該椎間融合器的軸柱扣合夾緊,並令該複數個第一單向齒與該複數個第二單向齒相嚙合,從而該二彈性夾臂通過彈力應變性改變該椎間融合器和該植入器械之间的夾持角度。 A method of operating a combination of an implant device and an interbody fusion cage, comprising: providing an interbody fusion cage, the intervertebral fusion device having a shaft column, and having a plurality of first one-way teeth on an outer circumference of the shaft column: providing An implant device comprising a clamping rod and a sliding sleeve, wherein the lower end portion of the clamping rod has two elastic clamping arms, and the outer side of the two elastic clamping arms respectively have a slope extending from the inside to the outside, and The inner sides of the ends of the two elastic clamping arms are respectively provided with symmetrical C-shaped crotch portions to jointly form a jaw portion, and a plurality of second one-way teeth are disposed on at least one C-shaped crotch portion, the sliding sleeve The sleeve can be sleeved on the clamping rod so that the lower end edge of the sliding sleeve can be sleeved around the outer inclined surface of the two elastic clamping arms, and the jaw portion of the clamping rod is exposed at the lower end edge of the sliding sleeve And the combination of the intervertebral cage and the implant device, the jaw portion of the implant device is fastened to the shaft post of the interbody cage, and the lower end edge of the sliding sleeve is moved to the sleeve The outer inclined surface of the two elastic clamping arms is arranged such that the jaw portion fastens and clamps the shaft column of the interbody cage, and The plurality of first one-way engagement with the plurality of teeth of the second one-way teeth, so that the two elastic clip arms to change the angle between the clamp and the cage by elastic strain of the implantation instrument. 如申請專利範圍第14項所述之植入器械與椎間融合器之組合的操作方法,還包含一變更該植入器械與該椎間融合器之間的夾持角度之操作步驟:在該植入器械與該椎間融合器扣合夾緊的情況下,以該鉗口部與該軸柱的夾持組合部位為中心點,將該植入器械的夾桿或該椎間融合器之一或二者依該中心點作旋轉位移一角度,如此一來,在該鉗口部夾合該軸柱狀態下,藉由該二彈性夾臂具有的彈力應變特性,該鉗口部的第二單向齒可順向的位移以脫離與該軸柱上原先嚙合的第一單向齒,並嚙合到該軸柱上的其他相鄰位置上的第一單向齒,以順著該第一單向齒的設置方向變換該植入器械與該椎間融合器之間的夾持角度。 The method for operating a combination of an implant device and an interbody cage as described in claim 14 further comprising the step of: changing a clamping angle between the implant device and the interbody cage: When the implant device is engaged and clamped by the intervertebral cage, the clamping rod of the implant device or the interbody cage is centered on the clamping portion of the jaw portion and the shaft column One or both are rotated at an angle according to the center point, so that the jaw portion is in the state in which the jaw portion is clamped by the jaw portion, and the elastic strain characteristic of the two elastic clip arms The two one-way teeth are directionally displaceable to disengage from the first one-way tooth originally engaged with the shaft post and to engage the first one-way tooth at other adjacent positions on the shaft post to follow the first The orientation of a one-way tooth changes the angle of grip between the implant device and the interbody cage. 如申請專利範圍第14項所述之植入器械與椎間融合器之組合的操作方法 ,還包含一釋放該植入器械與該椎間融合器之間的夾持組合之操作步驟:移動該滑套,使該滑套的下端緣套口位移離開該二彈性夾臂的外側斜面,藉由該二彈性夾臂的彈性回復力量作用使該鉗口部呈開啟狀態,該鉗口部釋放對該軸柱的夾持,因此該植入器械即可與該椎間融合器相互分離。 Method for operating a combination of an implant device and an interbody cage as described in claim 14 The method further includes the step of releasing a clamping combination between the implant device and the interbody cage: moving the sliding sleeve to displace the lower end edge of the sliding sleeve away from the outer inclined surface of the two elastic clamping arms, The jaw portion is opened by the elastic restoring force of the two elastic clip arms, and the jaw portion releases the clamping of the shaft column, so that the implant device can be separated from the interbody cage. 如申請專利範圍第14項所述之植入器械與椎間融合器之組合的操作方法,其中該複數個第一單向齒和該複數個第二單向齒為棘齒。 The method of operating a combination of an implant device and an interbody cage as described in claim 14, wherein the plurality of first one-way teeth and the plurality of second one-way teeth are ratchet teeth. 如申請專利範圍第14項所述之植入器械與椎間融合器之組合的操作方法,其中該植入器械還包括於該夾桿的中段部位設有一螺紋段,以及在該滑套上設有一調整螺帽,且該滑套串套在該夾桿上時,該調整螺帽可螺接於該夾桿的螺紋段上,藉轉動該調整螺帽使該夾桿與該滑套之間做軸向相對位移,可改變該滑套的下端緣套口與該二彈性夾臂的外側斜面之間的作用位置,據此操控該鉗口部的閉合或開啟。 The method of operating a combination of an implant device and an interbody fusion cage according to claim 14, wherein the implant device further comprises a threaded section at a middle portion of the clamping rod, and is disposed on the sliding sleeve When there is an adjusting nut, and the sliding sleeve is sleeved on the clamping rod, the adjusting nut can be screwed onto the threaded section of the clamping rod, and the adjusting nut is rotated to make the clamping rod and the sliding sleeve The axial relative displacement can change the working position between the lower end edge of the sliding sleeve and the outer inclined surface of the two elastic clamping arms, thereby controlling the closing or opening of the jaw portion. 如申請專利範圍第14項所述之植入器械與椎間融合器之組合的操作方法,其中所述椎間融合器還包括至少二個定位標靶,各個定位標靶以彼此分隔儘量遠離的設置於該主體上。 The method of operating a combination of an implant device and an interbody fusion cage according to claim 14, wherein the interbody fusion cage further comprises at least two positioning targets, each of which is separated from each other as far as possible. Set on the main body. 如申請專利範圍第19項所述之植入器械與椎間融合器之組合的操作方法,其中該定位標靶為一設在該椎間融合器上的鏤空部。 The method of operating a combination of an implant device and an interbody fusion cage according to claim 19, wherein the positioning target is a hollow portion disposed on the interbody cage.
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