TWI468143B - Minimally invasive spinal stabilization system - Google Patents
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Description
本發明是有關於一種脊柱固定組件,且特別是有關於一種微創侵入性脊柱固定組件及其植入方法。The present invention relates to a spinal fixation assembly, and more particularly to a minimally invasive invasive spinal fixation assembly and method of implantation thereof.
每年有一千三百萬人為了慢性背痛去看醫生,估計其中有兩百四十萬美國人成為慢性殘疾。大約有百分之二十五背部疼痛的人具有椎間盤突出(herniated disk)的問題。在美國,每十萬件椎間盤突出的病例約有四百五十件需要進行例如是椎間盤切除術(discectomy)的外科手術。Every year, 13 million people go to see a doctor for chronic back pain, and an estimated 2.4 million Americans become chronically disabled. About 25 percent of people with back pain have problems with herniated disks. In the United States, there are approximately 450 cases per 100,000 disc herniations requiring surgical procedures such as discectomy.
參照第1A圖,以往當椎間盤8已脫出或刺出,便施行椎間盤切除術(第1A圖)。當外科醫師施行椎間盤切除術時,通常由病人背上施行一切口(incision),此切口對應於脊柱2的患部區域。肌肉與韌帶被移至旁邊以暴露出有問題的椎間盤8。外科醫師使用各種外科手術用儀器,首先分離夾於椎間盤8之間的脊椎骨4,接著完全移開椎間盤8。施行椎間盤切除術後,在施行區域的脊柱被分離大約為被移除椎間盤的高度(第1B圖),接著一人工椎間盤被放置於分離處。脊柱固定裝置(第1C圖)在上述程序後的癒合程序間,被用以穩固且(或)校直脊柱2。在某些案例中,臨床醫師植入病患自體的骨頭(autologous bone)填滿分離處完成結合,如第1D圖所示,用以恢復脊柱2的穩固。可選擇地,椎間盤切除術後可施行脊柱癒合(spinal fusion)或其他被視作必要地,用以強化及矯直 脊髓的程序。Referring to Fig. 1A, in the past, when the intervertebral disc 8 has been detached or punctured, discectomy (Fig. 1A) was performed. When a surgeon performs a discectomy, an incision is usually performed on the patient's back, which corresponds to the affected area of the spine 2. The muscles and ligaments are moved aside to expose the problematic disc 8 . The surgeon uses various surgical instruments to first separate the vertebrae 4 sandwiched between the intervertebral discs 8, and then completely remove the intervertebral disc 8. After the discectomy, the spine in the area of application is separated approximately the height of the removed disc (Fig. 1B), followed by an artificial disc placed at the separation. The spinal fixation device (Fig. 1C) is used to stabilize and/or straighten the spine 2 between the healing procedures following the above procedure. In some cases, the clinician implants the patient's autologous bone to fill the separation to complete the binding, as shown in Figure 1D, to restore the stability of the spine 2. Alternatively, spinal fusion or other treatment may be performed after discectomy to strengthen and straighten Spinal cord procedure.
雖然椎間盤切除術經常地使用微創侵入性裝置(minimally invasive device)與程序來施行,但是提供必要的微創脊椎穩固以及其他脊椎相關的程序仍具有挑戰性。使用改良的微創脊柱固定裝置與方法是必要的,用以最小化病患的風險、創傷與恢復時間,並且減少程序中的總花費。While discectomy is often performed using minimally invasive devices and procedures, providing the necessary minimally invasive spinal stabilization and other spinal related procedures remains challenging. The use of modified minimally invasive spinal fixation devices and methods is necessary to minimize patient risk, trauma and recovery time, and to reduce overall costs in the procedure.
根據本發明,提出一種微創侵入性脊柱固定組件。微創侵入性脊柱固定組件為提供一系列脊椎骨相對固定,包括一固定棒與多數個椎根螺釘,每一椎根螺釘包括一頂部及一螺紋端,頂部配置為接受該固定棒之一部分,螺紋端自該頂部之一第一端延伸且配置為用以嚙合此些脊椎骨其中之一。此組件更包括一扣件,扣件包括多數個外螺紋,外螺紋配置為用以嚙合形成於頂部之一內表面之多數個對應螺紋。固定棒透過扣件被固定於頂部,且頂部包括一分離區域。分離區域包括頂部之一部分,頂部之此部分相較於頂部之剩餘部分在結構上較弱,用以定義一位置,在供應足夠的力至頂部之至少一第一部分時,頂部之第一部分可輕易地於此位置與頂部之剩餘部分分離。In accordance with the present invention, a minimally invasive invasive spinal fixation assembly is presented. The minimally invasive invasive spinal fixation assembly provides a series of relative fixation of the vertebrae, including a fixation rod and a plurality of vertebral screws, each vertebral screw including a top portion and a threaded end, the top portion configured to receive a portion of the fixation rod, the thread end from One of the top ends of the top extends and is configured to engage one of the vertebrae. The assembly further includes a fastener including a plurality of external threads configured to engage a plurality of corresponding threads formed on an inner surface of the top portion. The fixing rod is fixed to the top through the fastener, and the top portion includes a separation area. The separation region includes a portion of the top portion, the portion of the top portion being structurally weaker than the remainder of the top portion for defining a position, the first portion of the top portion being easily accessible when sufficient force is supplied to at least a first portion of the top portion This location is separated from the rest of the top.
微創侵入性脊柱固定組件可包括一或多個下列特徵:固定棒配置為用以容置一縫線。固定棒為一中空管。每一椎根螺釘包括第一端及一張開的第二端,第二端相對於第一端設置。頂部實質上為管狀,且由一單件所組成, 此單件具有一第一開口及一第二開口,第一開口沿著頂部之一軸向方向自第二端延伸至一位置,此位置相鄰且空間上分離於第一端,第二開口相對於第一開口位於頂部的一相反側,第二開口沿著頂部之一軸向方向自第二端延伸至一位置,此位置相鄰且空間上分離於第一端。第一與第二開口完全地對齊,用以形成一橫向穿越通道,穿越通道穿過頂部。一帽蓋可被配置為用以嚙合椎根螺釘之頂部之第二端。帽蓋包括一中空圓柱形本體及一對置端,本體具有一張開端,用以接受頂部之一第二端於其中,對置端包括一中央帽蓋開口。第一端包括一內表面,此內表面具有一環狀突起,且頂部包括一環形溝槽,環形溝槽相鄰於第二端,配置為用以嚙合環狀突起,藉以使帽蓋可拆卸地固定於頂部之第二端。The minimally invasive invasive spinal fixation assembly can include one or more of the following features: The fixation rod is configured to receive a suture. The fixing rod is a hollow tube. Each vertebral screw includes a first end and an open second end, the second end being disposed relative to the first end. The top is substantially tubular and consists of a single piece. The single piece has a first opening and a second opening, the first opening extending from the second end to a position along an axial direction of the top, the position being adjacent and spatially separated from the first end, the second opening With respect to the opposite side of the first opening at the top, the second opening extends from the second end to a position along one of the axial directions of the top, the position being adjacent and spatially separated from the first end. The first and second openings are fully aligned to form a transverse passageway that passes through the passageway. A cap can be configured to engage the second end of the top of the pedicle screw. The cap includes a hollow cylindrical body and a pair of ends, the body having an open end for receiving a second end of the top portion therein, the opposite end including a central cap opening. The first end includes an inner surface having an annular projection, and the top portion includes an annular groove adjacent to the second end, configured to engage the annular projection to thereby disassemble the cap The ground is fixed to the second end of the top.
微創侵入性脊柱固定組件可包括一或多個下列特徵:一U形椎根螺釘穩定器。穩定器包括一握把部分、一環狀基座及一對接腳,環狀基座自握把部分之一側延伸,具有一實質上等於頂部直徑的直徑,對接腳自環狀基座之一側延伸,對接腳配置為個別符合頂部之第一與第二開口的形狀,且可被接受於其中。一帽蓋可被配置為用以閉合椎根螺釘頂部之第二端,帽蓋包括一帽蓋開口,椎根螺釘穩定器之對接腳可穿過此開口而被接受。對應於帽蓋開口之帽蓋邊緣的一部分,具有一形狀,此形狀符合一接腳之一剖面形狀。微創侵入性脊柱固定組件更包括一椎根螺釘斷裂裝置,被接受於椎根螺釘頂部之一內部空間,用以促使頂部之第二端沿著頂部上之一預定環狀分離線,自頂部 之第一端分離預定環狀分離線位於頂部之第一端與第二端之間。The minimally invasive invasive spinal fixation assembly can include one or more of the following features: a U-shaped vertebral screw stabilizer. The stabilizer includes a grip portion, an annular base and a pair of legs, the annular base extending from one side of the grip portion and having a diameter substantially equal to the diameter of the top, the butt joint from one of the annular bases The side extensions are configured to individually conform to the shape of the first and second openings of the top and are receivable therein. A cap can be configured to close the second end of the apical screw top, the cap including a cap opening through which the butt joint of the pedicle screw stabilizer can be accepted. A portion of the edge of the cap corresponding to the opening of the cap has a shape that conforms to a cross-sectional shape of one of the pins. The minimally invasive invasive spinal fixation assembly further includes a vertebral screw breaking device that is received in an interior space of the top of the vertebral screw to urge the second end of the top along a predetermined annular separation line on the top, from the top The first end separates the predetermined annular separation line between the first end and the second end of the top.
微創侵入性脊柱固定組件可包括一或多個下列特徵:一引線及一引導工具,引線用以維持一縫線,引導工具包括樞接的一第一加長臂與一第二加長臂。第一加長臂終止於一公縫線導引之一第一端,第二加長臂終止於一母縫線導引之一第一端。公縫線導引與母縫線導引係用以使引線於第一與第二加長臂於一張開位置與一閉合位置移動時,可自公縫線導引被傳送至母縫線導引,張開位置係為公縫線導引與母縫線導引被分開,閉合位置係為公縫線導引與母縫線導引相鄰。引線包括一尖端及一開口,尖端促使引線插入母縫線導引,開口形成於相鄰此尖端。第一與第二加長臂被接受於椎根螺釘頂部之中空內部空間,且穿過第一與第二開口。此系列脊椎骨包括至少兩塊脊椎骨。微創侵入性脊柱固定組件係透過多數個不連續的傷口施行,傷口之長度實質上對應於該頂部之一剖面直徑。The minimally invasive invasive spinal fixation assembly can include one or more of the following features: a lead and a guiding tool for maintaining a suture, the guiding tool including a first elongated arm and a second elongated arm pivoted. The first extension arm terminates at a first end of a male suture guide, and the second extension arm terminates at a first end of a female suture guide. The male suture guide and the female suture guide are used to guide the lead to the female suture guide from the male suture when the first and second extension arms are moved from an open position to a closed position. The open position is that the male suture guide is separated from the female suture guide, and the closed position is adjacent to the female suture guide. The lead includes a tip and an opening that urges the lead into the female stitch guide, the opening being formed adjacent the tip. The first and second extension arms are received in the hollow interior space at the top of the pedicle screw and through the first and second openings. This series of vertebrae includes at least two vertebrae. The minimally invasive invasive spinal fixation component is performed through a plurality of discrete wounds, the length of the wound substantially corresponding to a cross-sectional diameter of the top.
根據本發明,提出一種使用於脊柱固定的椎根螺釘,包括一頂部及一螺紋端,頂部包括一第一端及一張開的第二端,第二端相對於第一端,螺紋端自第一端延伸。頂部為管狀,且由一單件所組成,此單件具有一第一開口及一第二開口,第一開口沿著頂部之一軸向方向,自第二端延伸至一位置,此位置相鄰且分離於第一端,第二開口相對於第一開口位於頂部的一相反側,第二開口沿著頂部之一軸向方向自第二端延伸至一位置,位置相鄰且空間上分離於第一端。第一與第二開口完全地對齊,用以形成一橫向 穿越通道,穿越通道穿過頂部。According to the present invention, a pedicle screw for spinal fixation is provided, comprising a top end and a threaded end, the top portion including a first end and an open second end, the second end being opposite to the first end, the thread end being from the first end One end extends. The top is tubular and consists of a single piece having a first opening and a second opening, the first opening extending along the axial direction of the top from the second end to a position, the position Adjacent and separated from the first end, the second opening is located on an opposite side of the top with respect to the first opening, and the second opening extends from the second end to a position along one of the axial directions of the top, adjacent to each other and spatially separated At the first end. The first and second openings are completely aligned to form a lateral direction Cross the passage and cross the passage through the top.
椎根螺釘可包括一或多個下列特徵:頂部之第一端與第二端之間的距離介於40公釐至120公釐的範圍。頂部之第一端與第二端之間的距離介於50公釐至80公釐的範圍。頂部包括一分離區域,位於第一端與第二端之間,分離區域包括頂部之一部分,頂部之此部分相較於頂部之剩餘部分在結構上較弱,用以定義一位置,在供應一足夠的力至該第二端時,該第二端之至少一部分於該位置可輕易地自該頂部被分離。分離區域包括一環形溝槽,位於第一端與一中點之間,中點介於第一端與第二端之間,環形溝槽用以提供一預定分離線,當施加一足夠的力於第二端時,第二端之至少一部分可沿著預定分離線輕易地自頂部分離。力係為以頂部之一縱向軸為軸的一扭力。椎根螺釘更包括一可移除的帽蓋,用以閉合頂部之第二端,其中頂部包括一環形溝槽相鄰於第二端,用以嚙合一對應之環狀邊,環狀邊係位於帽蓋之一內表面。頂部之第一端用以使螺紋端可相對於頂部進行多軸旋轉。The pedicle screw can include one or more of the following features: the distance between the first end and the second end of the top is in the range of 40 mm to 120 mm. The distance between the first end and the second end of the top is in the range of 50 mm to 80 mm. The top portion includes a separation region between the first end and the second end, the separation region including a portion of the top portion, the portion of the top portion being structurally weaker than the remaining portion of the top portion for defining a position, When sufficient force is applied to the second end, at least a portion of the second end can be easily separated from the top at the location. The separation region includes an annular groove between the first end and a midpoint, the midpoint being between the first end and the second end, the annular groove is for providing a predetermined separation line when a sufficient force is applied At the second end, at least a portion of the second end can be easily separated from the top along a predetermined separation line. The force is a torque that is centered on one of the longitudinal axes of the top. The vertebral screw further includes a removable cap for closing the second end of the top, wherein the top portion includes an annular groove adjacent to the second end for engaging a corresponding annular edge, the annular edge being located One of the inner surfaces of the cap. The first end of the top is for the threaded end to be multi-axis rotatable relative to the top.
根據本發明,提出一種縫線導引組件,包括一引線及一引導工具,引線,用以維持一縫線,引導工具包括樞接的一第一加長臂與一第二加長臂,第一加長臂終止於一公縫線導引之一第一端,第二加長臂終止於一母縫線導引之一第一端。公縫線導引與母縫線導引係用以使該引線於第一與第二加長臂於一張開位置與一閉合位置移動時,可自公縫線導引被傳送至母縫線導引,張開位置係為公縫線導引與母縫線導引被分開,閉合位置係為公縫線導引與該母 縫線導引相鄰。According to the present invention, there is provided a suture guiding assembly comprising a lead and a guiding tool for maintaining a suture, the guiding tool comprising a first elongated arm and a second elongated arm pivoted, the first lengthening The arm terminates at a first end of a male suture guide and the second extension arm terminates at a first end of a female suture guide. The male suture guide and the female suture guide are used to guide the lead to the female stitch guide from the male suture when the first and second extension arms are moved from the open position to the closed position. In the open position, the male suture guide is separated from the female suture guide, and the closed position is the male suture guide and the mother. The sutures are guided adjacent.
縫線導引組件可包括一或多個下列特徵:引線包括一錐形尖端及一孔眼,孔眼自錐形尖端突出。公縫線導引包括一圓柱形柄桿,用以可拆卸地嚙合引線之孔眼,而母縫線導引包括一圓柱形殼體,用以可拆卸地嚙合於引線之錐形尖端,且引導工具用以支撐公縫線導引與母縫線導引,當引導工具處於閉合位置時,可使錐形尖端至少部分被接受於殼體之間。殼體包括一第一殼體開口與一第二殼體開口,引線穿過第一殼體開口插入殼體中,引線穿過第二殼體開口被從殼體中抽出。第二殼體開口之形狀實質上符合引線之形狀。第一殼體開口小於引線之最寬部分。引線包括一錐形尖端,且當該引導工具自開放位置移動至閉合位置時,引線之錐形尖端被驅動穿過第一殼體開口,同時可防止從第一殼體開口被收回。第一與第二加長臂係為有一角度。此角度介於90度至180度。The suture leader assembly can include one or more of the following features: the lead includes a tapered tip and an eyelet that projects from the tapered tip. The male suture guide includes a cylindrical shank for detachably engaging the eyelet of the lead, and the female suture guide includes a cylindrical housing for detachably engaging the tapered tip of the lead and guiding The tool is adapted to support the male suture guide and the female suture guide, and the tapered tip is at least partially received between the housings when the guiding tool is in the closed position. The housing includes a first housing opening and a second housing opening, the lead is inserted into the housing through the first housing opening, and the lead is withdrawn from the housing through the second housing opening. The shape of the second housing opening substantially conforms to the shape of the lead. The first housing opening is smaller than the widest portion of the lead. The lead includes a tapered tip, and when the guiding tool is moved from the open position to the closed position, the tapered tip of the lead is driven through the first housing opening while preventing retraction from the first housing opening. The first and second extension arms are at an angle. This angle is between 90 and 180 degrees.
參照第2圖,被用於穩固脊柱2的微創脊柱固定組件20包括一固定棒200、椎根螺釘300以及一扣件500(未繪示於第2圖中,請參照第5圖)。固定棒200具有足夠的長度延伸穿越脊椎骨4,用以穩固脊椎骨4。椎根螺釘300用以扣牢固定棒200至每個對應的脊椎骨4。在每一椎根螺釘300上的扣件500用以扣緊固定棒200至椎根螺釘300。每一椎根螺釘300穿過一小皮膚切口被植入對應之脊椎骨4的椎根6中,皮膚切口具有實質上對應椎根螺釘300剖面尺寸的長度。在所繪示之實施例中,舉例來說,切口為1公分或小於1公分,且固定棒200經由1公分或 小於1公分的皮膚切口,被組裝於椎根螺釘300,下面將進一步討論。Referring to Fig. 2, the minimally invasive spinal fixation assembly 20 used to stabilize the spine 2 includes a fixation rod 200, a pedicle screw 300, and a fastener 500 (not shown in Fig. 2, see Fig. 5). The fixation rod 200 has a sufficient length to extend across the vertebra 4 to stabilize the vertebra 4. The pedicle screw 300 is used to fasten the fixation rod 200 to each corresponding vertebra 4. A fastener 500 on each vertebral screw 300 is used to fasten the fixation rod 200 to the pedicle screw 300. Each vertebral screw 300 is implanted through a small skin incision into the vertebral root 6 of the corresponding vertebra 4, the skin incision having a length substantially corresponding to the cross-sectional dimension of the vertebral screw 300. In the illustrated embodiment, for example, the slit is 1 cm or less, and the fixing rod 200 is 1 cm or A skin incision of less than 1 cm is assembled to the pedicle screw 300, as discussed further below.
參照第3圖,固定棒200具有容置一縫線空間之結構,此處之縫線被定義作一加長的羊腸線、尼龍線或纖維,例如是絲線或金屬線。在所繪示之實施例中,固定棒200為一中空管,包括第一端212、第二端214以及內通道210。第二端214相對於第一端212,內通道210在第一端212與第二端214之間延伸。在此實施例中,固定棒200可容納一縫線於內通道210中。Referring to Fig. 3, the fixing rod 200 has a structure for accommodating a suture space, where the suture is defined as an elongated gut, nylon thread or fiber, such as a thread or a metal wire. In the illustrated embodiment, the fixed rod 200 is a hollow tube including a first end 212, a second end 214, and an inner passage 210. The second end 214 is opposite the first end 212 and the inner passage 210 extends between the first end 212 and the second end 214. In this embodiment, the fixed bar 200 can accommodate a suture in the inner channel 210.
與其剖面尺寸相比,固定棒200相對較長。在所繪示之實施例中,固定棒200為圓柱形,具有5.5mm的直徑,其軸向長度則對應被穩固之脊柱2的總長度。舉例來說,要穩固兩個相鄰的脊椎骨4,固定棒的長度大約為60.0mm長。要穩固一系列四個相鄰的脊椎骨4,固定棒的長度大約為150.0mm長。固定棒200可由一種可植入材料所形成,且由一種具有足夠強度與硬度可穩固脊柱,同時也具有足夠的可塑性得以使固定棒200形成曲狀的材料所形成。舉例來說,固定棒200可由一種鈦合金所形成,例如是鈦六鋁四釩(Ti6 Al4 V)。The fixed rod 200 is relatively long compared to its cross-sectional dimension. In the illustrated embodiment, the fixation rod 200 is cylindrical, having a diameter of 5.5 mm, the axial length of which corresponds to the total length of the stabilized spine 2. For example, to stabilize two adjacent vertebrae 4, the length of the fixation rod is approximately 60.0 mm long. To stabilize a series of four adjacent vertebrae 4, the length of the rod is approximately 150.0 mm long. The fixation rod 200 can be formed of an implantable material and formed of a material having sufficient strength and stiffness to stabilize the spine while also having sufficient plasticity to cause the fixation rod 200 to form a curved shape. For example, the fixing rod 200 may be formed of a titanium alloy such as titanium hexaluminum tetravanadium (Ti 6 Al 4 V).
參照第4圖,軸向椎根螺釘300被用來扣牢固定棒200至每一對應之脊椎骨4。每一椎根螺釘300可植入穿過1公分或小於1公分的皮膚切口,且被旋入對應脊椎骨4之椎根中,脊椎骨4在皮膚底下且位於一般男性肌肉深度約5公分深處。為此,每一椎根螺釘300包括一加長的頂部302與螺紋端304。Referring to Figure 4, an axial vertebral screw 300 is used to secure the fixation rod 200 to each corresponding vertebra 4. Each vertebral screw 300 can be implanted through a skin incision of 1 cm or less and screwed into the vertebral root of the corresponding vertebra 4, which is under the skin and at a depth of about 5 cm from the average male muscle. To this end, each vertebral screw 300 includes an elongated top portion 302 and a threaded end 304.
頂部302實質上為管狀,且由一單件所組成。頂部302包括一封閉的第一端306以及一開放的第二端308,第二端308相對於第一端306。頂部302附帶一第一軸向延伸開口310,第一開口310自第二端308延伸至第一端306且與第一端306分開。頂部302也附帶一第二軸向延伸開口312,第二開口312位於頂部302相對於第一開口310之一側。第二開口312鏡像於第一開口310,第二開口312自第二端308延伸至第一端306且與第一端306分開。第一與第二開口310、312完全地對齊,以形成一橫向穿越通道316穿過頂部302。因此,頂部302實質上為U型。The top portion 302 is substantially tubular and is comprised of a single piece. The top portion 302 includes a closed first end 306 and an open second end 308, the second end 308 being opposite the first end 306. The top portion 302 is provided with a first axially extending opening 310 that extends from the second end 308 to the first end 306 and is separate from the first end 306. The top portion 302 also carries a second axially extending opening 312 that is located on one side of the top portion 302 relative to the first opening 310. The second opening 312 is mirrored to the first opening 310 and the second opening 312 extends from the second end 308 to the first end 306 and is separate from the first end 306. The first and second openings 310, 312 are fully aligned to form a transverse passage 316 through the top 302. Thus, the top 302 is substantially U-shaped.
頂部302在軸向相對於其剖面尺寸更長。舉例來說,在繪示之實施例中,第一端306與第二端308之間的距離d1介於4公分至12公分的範圍,然而頂部302之直徑大約為1公分。在另一實施例中,距離d1可介於5公分至8公分的範圍。The top portion 302 is axially longer relative to its cross-sectional dimension. For example, in the illustrated embodiment, the distance d1 between the first end 306 and the second end 308 ranges from 4 cm to 12 cm, whereas the top 302 has a diameter of approximately 1 cm. In another embodiment, the distance d1 may range from 5 cm to 8 cm.
頂部302附帶一環狀分離區域318,分離區域318位於第一端306與第二端308之間。在所繪示之實施例中,分離區域318位於第一端306與一中點P之間,中點P介於第一端與第二端306、308之間。因此,頂部302被分離區域318分隔為兩部分。一腹側部322在第一端306與分離區域318之間延伸;一背側部324在分離區域318與第二端308之間延伸。分離區域318為頂部302之一區域,相較於頂部其他區域,分離區域318在結構上相對較弱,用以定義一周線(circumferential line),沿著該周線,背側部324被施加足夠的力,可使背側部324與腹側部322 輕易分離。在所繪示之實施例中,分離區域318係為一圓周延伸的V型溝槽320。在某些實施例中,脊柱固定組件20可包括一螺釘斷裂工具800,被配置以提供頂部302的縱軸扭力,因此可選擇地將背側部324在溝槽320處與腹側部322分離,下面將進一步說明。可以理解的是,即便是提供一彎曲力也可使背側部324完成分離,使用扭力相較於彎曲力將對周圍組織造成較少的破壞。The top portion 302 is provided with an annular separation region 318 that is located between the first end 306 and the second end 308. In the illustrated embodiment, the separation region 318 is located between the first end 306 and a midpoint P between the first end and the second end 306, 308. Thus, the top portion 302 is divided into two portions by the separation region 318. A ventral side 322 extends between the first end 306 and the separation region 318; a back side 324 extends between the separation region 318 and the second end 308. The separation region 318 is one of the top regions 302, and the separation region 318 is relatively weak in structure compared to the other regions on the top to define a circumferential line along which the back side portion 324 is applied. The force of the back side 324 and the ventral side 322 Easy to separate. In the illustrated embodiment, the separation region 318 is a circumferentially extending V-shaped groove 320. In certain embodiments, the spinal fixation assembly 20 can include a screw fracture tool 800 configured to provide longitudinal axis torsion of the top portion 302, thereby selectively separating the back side portion 324 from the ventral portion 322 at the groove 320. , will be further explained below. It will be appreciated that even if a bending force is provided, the back side portion 324 can be separated, and the use of torsion forces will cause less damage to the surrounding tissue than the bending force.
腹側部322之內表面附帶有螺紋326,螺紋326被配置用以嚙合對應的扣件500之外表面506上之螺紋508,下面將進一步說明。此外,固位溝槽332被形成於頂部302之外表面且相鄰於第二端308。固位溝槽332被設定尺寸並安置,用以容納與維持一對應的環狀隆起610,環狀隆起610形成於螺釘帽蓋600之內表面上,下面將進一步說明。The inner surface of the ventral portion 322 is provided with threads 326 that are configured to engage threads 508 on the outer surface 506 of the corresponding fastener 500, as further described below. Further, a retention groove 332 is formed on the outer surface of the top portion 302 and adjacent to the second end 308. The retention groove 332 is sized and disposed to receive a corresponding annular ridge 610 formed on the inner surface of the screw cap 600, as further described below.
椎根螺釘300之螺紋端304自頂部302之第一端306向外延伸。更具體地說,螺紋端304包括一基底342與一柄部344,基底342支撐於頂部302之第一端306中,柄部344自基底342延伸。頂部302之第一端306被配置,使螺紋端304得以相對於頂部302作三維旋轉。柄部344具有外螺紋348且終止於頂端346。此外,螺紋端304包括通道穿孔350,通道穿孔350開口於基底342,延伸穿過柄部344並開口於頂端346。The threaded end 304 of the pedicle screw 300 extends outwardly from the first end 306 of the top portion 302. More specifically, the threaded end 304 includes a base 342 and a handle 344 that is supported in the first end 306 of the top 302 and the handle 344 extends from the base 342. The first end 306 of the top portion 302 is configured to allow the threaded end 304 to be rotated three-dimensionally relative to the top portion 302. The handle 344 has an external thread 348 and terminates at a top end 346. In addition, the threaded end 304 includes a passage aperture 350 that opens into the base 342, extends through the handle 344 and opens into the top end 346.
參照第5圖,扣件500為圓柱形元件,具有外螺紋508形成於外表面506。螺紋508被配置,用以嚙合形成於椎根螺釘頂部302之腹側部322內表面所對應之螺紋326。 在繪示之實施例中,扣件500為止付螺釘(set screw),螺釘配置第一端502,用以容納驅動工具。舉例來說,第一端502包括六角形的管座510,適合容納六角扳手或一促動器850之定型部分892(詳述如下)。在使用中,扣件500被緊扣於椎根螺釘頂部302之腹側部322,用以維持固定棒200相對於椎根螺釘300的位置。Referring to Figure 5, fastener 500 is a cylindrical member having external threads 508 formed on outer surface 506. The threads 508 are configured to engage threads 326 formed on the inner surface of the ventral side portion 322 of the apical screw top 302. In the illustrated embodiment, the fastener 500 is a set screw that is configured with a first end 502 for receiving a drive tool. For example, the first end 502 includes a hexagonal header 510 adapted to receive a hex wrench or a shaped portion 892 of an actuator 850 (described in detail below). In use, the fastener 500 is secured to the ventral side portion 322 of the pedicle screw top 302 to maintain the position of the fixation rod 200 relative to the vertebral screw 300.
參照第4圖,脊柱固定組件20更包括可卸除的螺釘帽蓋600,帽蓋600具有合適的形狀與尺寸,能扣緊椎根螺釘頂部302之第二端308,用以支撐與穩固頂部302之第二端308,且在插入穩固工具700至椎根螺釘300之中空內部時,可用來導引穩固工具700之方向(詳述如下)。螺釘帽蓋600為中空圓柱,具有開放的第一端602、封閉的第二端604以及側壁606,第二端604相對於第一端602,側壁606在第一端602與第二端604之間延伸。開放的第一端602具有合適的尺寸,用以容納椎根螺釘頂部302之第二端308於其中。Referring to Figure 4, the spine fixation assembly 20 further includes a removable screw cap 600 having a suitable shape and size to fasten the second end 308 of the pedicle screw top 302 for supporting and stabilizing the top 302. The second end 308, and when the stabilization tool 700 is inserted into the hollow interior of the vertebral screw 300, can be used to guide the direction of the stabilization tool 700 (described in detail below). The screw cap 600 is a hollow cylinder having an open first end 602, a closed second end 604, and a side wall 606, the second end 604 being opposite the first end 602, and the side wall 606 being at the first end 602 and the second end 604 Extended between. The open first end 602 is sized to receive the second end 308 of the pedicle screw top 302 therein.
螺釘帽蓋600之側壁606附帶有第一軸向延伸帽蓋開口612,第一帽蓋開口612自第一端602延伸至第二端604且與第二端604分開。螺釘帽蓋之側壁606也附帶有第二軸向延伸帽蓋開口614,第二帽蓋開口614相對於第一帽蓋開口612位在側壁606之相反側。第二帽蓋開口614鏡射於第一帽蓋開口612,第二帽蓋開口614自第一端602延伸至第二端604且與第二端604分開。第一與第二帽蓋開口612、614完全地對齊,用以形成橫向穿越通道616穿過螺釘帽蓋600。當螺釘帽蓋600被設置於椎根螺釘頂 部302之第二端308,螺釘帽蓋600橫向穿越通道616可與椎根螺釘穿越通道316對齊。The sidewall 606 of the screw cap 600 is provided with a first axially extending cap opening 612 that extends from the first end 602 to the second end 604 and is separate from the second end 604. The side wall 606 of the screw cap is also provided with a second axially extending cap opening 614 that is positioned on the opposite side of the side wall 606 relative to the first cap opening 612. The second cap opening 614 is mirrored at the first cap opening 612, and the second cap opening 614 extends from the first end 602 to the second end 604 and is separate from the second end 604. The first and second cap openings 612, 614 are fully aligned to form a transverse through passage 616 through the screw cap 600. When the screw cap 600 is placed on the vertebral screw top At the second end 308 of the portion 302, the screw cap 600 laterally traverses the channel 616 to align with the pedicle screw passage 316.
螺釘帽蓋600包括內突的環狀隆起610,環狀隆起610形成於側壁606之內表面上,被設定尺寸並安置,用以嚙合形成於椎根螺釘之第二端308上的固位溝槽332。環狀隆起610延伸約側壁之內周長,且接合於固位溝槽332,用以維持螺釘帽蓋600於椎根螺釘之第二端308上。The screw cap 600 includes an inwardly projecting annular ridge 610 formed on the inner surface of the side wall 606, sized and positioned for engaging a retention groove formed in the second end 308 of the vertebral screw 332. The annular ridge 610 extends about the inner perimeter of the sidewall and engages the retention groove 332 to maintain the screw cap 600 on the second end 308 of the pedicle screw.
此外,螺釘帽蓋600之第二端604包括中央開口618。中央開口618為不規則形,包括實質上為圓形的中央部分622與細長部分624,每一細長部分624沿著中央部分622相對設置,且與中央部分交錯設置。在所繪示之實施例中,中央部分622具有合適的形狀與尺寸,用以使手術工具能穿過螺釘帽蓋600,進入椎根螺釘之頂部302之內部空間。此外,細長部分624具有合適的形狀與尺寸,當穩固工具700被插入椎根螺釘300之內部時,用以容納穩固工具700之穩固工具腳712(詳述如下)。應注意的是,中央開口618之細長部分624沿著第二端604之周圍設置,用以分別疊加於第一與第二帽蓋開口612、614之上。這樣的結構確保在裝配椎根螺釘300、帽蓋600與穩固工具700後,穩固工具700之穩固工具腳712可分別對齊於椎根螺釘之頂部302之第一與第二開口310、312,下面將進一步討論。Additionally, the second end 604 of the screw cap 600 includes a central opening 618. The central opening 618 is of an irregular shape and includes a substantially circular central portion 622 and an elongated portion 624, each elongated portion 624 being disposed opposite the central portion 622 and staggered with the central portion. In the illustrated embodiment, the central portion 622 has a suitable shape and size for the surgical tool to pass through the screw cap 600 into the interior space of the top 302 of the pedicle screw. In addition, the elongated portion 624 has a suitable shape and size for receiving the securing tool foot 712 of the securing tool 700 (described in detail below) when the stabilizing tool 700 is inserted into the interior of the pedicle screw 300. It should be noted that the elongated portion 624 of the central opening 618 is disposed along the circumference of the second end 604 for superposition on the first and second cap openings 612, 614, respectively. Such a configuration ensures that after assembly of the pedicle screw 300, the cap 600 and the stabilization tool 700, the securing tool feet 712 of the stabilization tool 700 can be respectively aligned with the first and second openings 310, 312 of the top 302 of the pedicle screw, further below discuss.
脊柱固定組件20更包括穩固工具700,穩固工具700為中空圓柱體且包括開放的第一端702、封閉的第二端704以及側壁706。第二端704相對於第一端702,側壁706 在第一端702與第二端704之間延伸。側壁706被設置為具有對應於椎根螺釘之頂部302的外徑與在直徑方向上相對的開口708、710,開口708、710自第一端702至相鄰於第二端704軸向延伸。開口708、710使側壁706實質上為U型,包括穩固工具腳712,腿部分藉由環狀基底部分714而結合於側壁706。握把部分716被設置於基底部分714與第二端704之間,第二端704具有相較於基底部分714更大的外徑。握把部分716包括表面特徵,例如是軸向延伸溝槽718,用以增加可握持性。此外,第二端704包括中央開口(未於第4圖中繪出),以使該些工具可被插入其中。The spinal fixation assembly 20 further includes a stabilization tool 700 that is a hollow cylinder and that includes an open first end 702, a closed second end 704, and a sidewall 706. The second end 704 is opposite to the first end 702, the side wall 706 Extending between the first end 702 and the second end 704. The sidewall 706 is configured to have an outer diameter corresponding to the outer diameter of the top 302 of the vertebral screw and an diametrically opposed opening 708, 710 that extends axially from the first end 702 to adjacent the second end 704. The openings 708, 710 cause the side wall 706 to be substantially U-shaped, including a securing tool foot 712 that is coupled to the side wall 706 by an annular base portion 714. The grip portion 716 is disposed between the base portion 714 and the second end 704, the second end 704 having a larger outer diameter than the base portion 714. The grip portion 716 includes surface features, such as axially extending grooves 718, to increase grip. Additionally, the second end 704 includes a central opening (not depicted in Figure 4) to allow the tools to be inserted therein.
當穩固工具700組裝於帽蓋600與椎根螺釘300時,穩固工具腳712定於椎根螺釘之頂部302之開口310、312中(見第4A圖)。在脊柱固定組件20植入期間,穩固工具700用於安置固定棒200於椎根螺釘之頂部302之內部空間中。此外,當扣件500用於扣緊固定棒200於椎根螺釘之頂部的腹側部時,穩固工具700用於維持固定棒200的位置。在植入後,將背側部324自腹側部322分離的期間,穩固工具700用於加強背側部324,以下將進一步討論。When the stabilization tool 700 is assembled to the cap 600 and the pedicle screw 300, the stabilization tool foot 712 is positioned in the opening 310, 312 of the top 302 of the vertebral screw (see Figure 4A). During implantation of the spinal fixation assembly 20, the stabilization tool 700 is used to position the fixation rod 200 in the interior space of the top 302 of the pedicle screw. Further, the securing tool 700 is used to maintain the position of the fixed bar 200 when the fastener 500 is used to fasten the ventral portion of the fixation rod 200 to the top of the vertebral screw. After implantation, the stabilization tool 700 is used to reinforce the dorsal portion 324 during separation of the dorsal side 324 from the ventral side 322, as discussed further below.
參照第6A至6C圖,脊柱固定組件20更包括螺釘斷裂工具800,螺釘斷裂工具800被配置於椎根螺釘之頂部302之內部空間中,一旦椎根螺釘之腹側部322與固定棒200被正確地放置且互相固定,螺釘斷裂工具800用以移除椎根螺釘之頂部302的背側部324。螺釘斷裂工具800 包括套管820與T型促動器850,促動器850具有合適的形狀與尺寸可被容納於套管820中(第6A圖)。套管820為一中空圓柱,包括開放的第一端802、第二端804以及側壁806。第二端804相對於第一端802,側壁806在第一端802與第二端804之間延伸。一對溝槽814(只有一個溝槽814被繪示)自第一端802朝套管820之中央部分延伸。溝槽814將第一端802分為兩部分802a、802b。握把區域810被置於第二端804上,相較於側壁806具有更大的外徑,且握把區域810包括表面特徵,例如是軸向延伸溝槽818,用以增加可握性。此外,第二端804包括中央開口812,中央開口812使包括促動器850等工具可被插入其中。套管820之軸向長度,相較於裝配後之椎根螺釘300、帽蓋600以及穩固工具700的軸向長度更長。Referring to Figures 6A through 6C, the spinal fixation assembly 20 further includes a screw fracture tool 800 that is disposed in the interior space of the top 302 of the vertebral screw once the ventral portion 322 of the pedicle screw and the fixation rod 200 are properly positioned. Placed and secured to each other, a screw breaking tool 800 is used to remove the dorsal portion 324 of the top 302 of the pedicle screw. Screw breaking tool 800 A sleeve 820 and a T-actuator 850 are included, the actuator 850 having a suitable shape and size that can be received in the sleeve 820 (Fig. 6A). The sleeve 820 is a hollow cylinder including an open first end 802, a second end 804, and a side wall 806. The second end 804 is opposite the first end 802 and the sidewall 806 extends between the first end 802 and the second end 804. A pair of grooves 814 (only one groove 814 is shown) extend from the first end 802 toward a central portion of the sleeve 820. Trench 814 divides first end 802 into two portions 802a, 802b. The grip region 810 is placed on the second end 804 with a larger outer diameter than the sidewall 806, and the grip region 810 includes surface features, such as axially extending grooves 818, for increased grip. Additionally, the second end 804 includes a central opening 812 into which a tool, including an actuator 850, can be inserted. The axial length of the sleeve 820 is longer than the axial length of the assembled vertebral screw 300, cap 600, and stabilization tool 700.
促動器850包括柄部854,柄部854具有第一端856及第二端858。握把852被固定於第二端858,使促動器850為一T型。柄部之第一端856包括喇叭形部分890及定型部分892,定型部分892自喇叭形部分890延伸(如第6B圖所繪示)。定型部分892之外剖面具有表面特徵使其能夠嚙合於扣件500之管座510。舉例來說,在繪示之實施例中,定型部分892之剖面為六角形,用以嚙合扣件500之六角柱管座510。喇叭形部分890具有相較於套管之側壁806與椎根螺釘之頂部302之內部空間更大的外尺寸。當促動器850被配置於套管820中且喇叭形部分890突出於套管之第一端802時,套管820可被插入椎根螺釘之頂部302,舉例來說用以扣緊扣件500至椎根螺釘302 頂部。藉由向上拉動促動器或向下壓入套管820並旋轉握把810,使喇叭形部分890之至少一部分被置於套管820之第一端之中,喇叭形部分890導致兩端802a與802b稍微分離。透過這個動作,套管820之外牆被朝椎根螺釘之頂部的背側部324壓縮。由於套管820摩擦嚙合於椎根螺釘之頂部302,藉由沿著握把810向下之縱軸旋轉,扭力便施加於椎根螺釘之頂部的背側部324。當施加足夠的力量,椎根螺釘之頂部302的背側部324可沿著分離區域318與腹側部322分離(如第6C圖所繪示)。The actuator 850 includes a handle 854 having a first end 856 and a second end 858. The grip 852 is secured to the second end 858 such that the actuator 850 is a T-shape. The first end 856 of the handle includes a flared portion 890 and a shaped portion 892 that extends from the flared portion 890 (as depicted in Figure 6B). The outer section of the shaped portion 892 has surface features that enable it to engage the stem 510 of the fastener 500. For example, in the illustrated embodiment, the shaped portion 892 has a hexagonal cross-section for engaging the hexagonal column header 510 of the fastener 500. The flared portion 890 has an outer dimension that is larger than the inner space of the side wall 806 of the cannula and the top 302 of the pedicle screw. When the actuator 850 is disposed in the sleeve 820 and the flared portion 890 protrudes from the first end 802 of the sleeve, the sleeve 820 can be inserted into the top 302 of the pedicle screw, for example, to fasten the fastener 500 To vertebral screw 302 top. At least a portion of the flared portion 890 is placed in the first end of the sleeve 820 by pulling the actuator up or down into the sleeve 820 and rotating the grip 810, the flared portion 890 causing the ends 802a Slightly separated from 802b. Through this action, the outer wall of the cannula 820 is compressed toward the dorsal portion 324 at the top of the vertebral screw. Since the sleeve 820 is frictionally engaged with the top 302 of the pedicle screw, the torsion is applied to the dorsal portion 324 at the top of the vertebral screw by rotation along the downward longitudinal axis of the grip 810. When sufficient force is applied, the dorsal portion 324 of the apex screw top 302 can be separated from the ventral portion 322 along the separation region 318 (as depicted in Figure 6C).
參照第7圖,使用一縫線導引組件900,植入固定棒200於個別椎根螺釘302之頂部,以下將進一步討論。縫線導引組件900包括具有一對加長臂982、984的引導工具980,加長臂982、984透過一樞軸銷986連接於加長臂982、984個別之第一端988與第二端990之間。每一加長臂982、984之第一端988被形成為指環992,用以使引導工具980得以手動引動,每一加長臂982、984之第二端990配置為具有縫線導引940、960。在引動過程中,引導工具980以樞軸銷986為軸做一剪形動作(scissoring motion)。Referring to Figure 7, a suture guide assembly 900 is used to implant the fixation rod 200 on top of the individual vertebral screws 302, as discussed further below. The suture leader assembly 900 includes a guide tool 980 having a pair of extension arms 982, 984 that are coupled to the first end 988 and the second end 990 of the extension arms 982, 984 via a pivot pin 986. between. The first end 988 of each extension arm 982, 984 is formed as a finger ring 992 for manual actuation of the guiding tool 980, and the second end 990 of each extension arm 982, 984 is configured to have a suture guide 940, 960 . During the priming process, the guiding tool 980 performs a scissoring motion with the pivot pin 986 as the axis.
引導工具980之第一與第二加長臂982、984具有可被容納至椎根螺釘頂部302之中空內部空間的尺寸,並沿著椎根螺釘頂部302之軸向長度伸長。此外,引導工具980以一剪形動作操作,第一加長臂982與第二加長臂984在一張開位置(如第7與22-23圖所繪示)與閉合位置(如第24圖所繪示)間移動,於張開位置加長臂982、984分 離為一第一距離,於閉合位置加長臂982、984分離為一第二距離,第一距離大於第二距離。當引導工具980插入椎根螺釘300中,第一、第二加長臂982、984具有能夠通過椎根螺釘頂部第一與第二開口310、312的尺寸,以下將進一步討論。在某些實施例中,第一與第二加長臂982’、984’可為有角度的。舉例來說,加長臂982’、984’可於樞軸銷986’與加長臂之第二端990’之間具有一角度,使第二端990’不位於指環992’所定義之平面(如第39圖所繪示)。加長臂的角度可介於90-180度的範圍間。The first and second extension arms 982, 984 of the guiding tool 980 have dimensions that can be received into the hollow interior space of the vertebral screw top 302 and are elongated along the axial length of the pedicle screw top 302. In addition, the guiding tool 980 operates in a scissoring action, and the first elongating arm 982 and the second elongating arm 984 are in an open position (as shown in Figures 7 and 22-23) and in a closed position (as shown in Fig. 24). Move between shows), add 982, 984 points in the open position Dividing from a first distance, the elongated arms 982, 984 are separated into a second distance in the closed position, the first distance being greater than the second distance. When the guiding tool 980 is inserted into the pedicle screw 300, the first and second elongate arms 982, 984 have dimensions that can pass through the apical screw top first and second openings 310, 312, as discussed further below. In some embodiments, the first and second extension arms 982', 984' can be angled. For example, the extension arms 982', 984' can have an angle between the pivot pin 986' and the second end 990' of the extension arm such that the second end 990' is not located in the plane defined by the finger ring 992' (eg, Figure 39 shows). The angle of the extension arm can be in the range of 90-180 degrees.
縫線導引組件900也包括一引線920,用以固定縫線1216、公縫線導引940、母縫線導引960,公縫線導引940裝設於引導工具980之第一加長臂982的一端,母縫線導引960裝設於引導工具980之第二加長臂984的一端。The suture guiding assembly 900 also includes a lead 920 for fixing the suture 1216, the male suture guide 940, the female suture guide 960, and the male suture guide 940 is mounted on the first extension arm of the guiding tool 980. At one end of the 982, the female stitch guide 960 is mounted at one end of the second extension arm 984 of the guiding tool 980.
參照第7圖,細節A,引線920包括一具有頂點926之錐形尖端922。此外,引線920包括一孔眼924,孔眼924自尖端922上反向於頂點926之側邊928突出。孔眼924之孔徑小於側邊928之直徑。在使用上,縫線1216被牢固於使用孔眼924的引線920上,以下將進一步討論。Referring to Figure 7, detail A, lead 920 includes a tapered tip 922 having a vertex 926. In addition, lead 920 includes an eyelet 924 that protrudes from tip 922 opposite side 928 of vertex 926. The aperture of the aperture 924 is smaller than the diameter of the side 928. In use, the suture 1216 is secured to the lead 920 using the eyelet 924, as discussed further below.
公縫線導引940包括一基座946與一圓柱形柄桿942,基座946被引導工具加長臂982之第二端990容置與支撐,圓柱形柄桿942自基座946之軸向端延伸。柄桿942被配置用以可釋放地吸引引線孔眼924。尤其,柄桿942包括一軸向延伸開口948,在推壓孔眼924時,開口948具有可容置孔眼924之合適尺寸。柄桿942也包括一橫向開口950,開口950延伸穿越柄桿942的一橫向於軸 向開口948之直徑,並且與軸向開口948交會。因此,當引線920之孔眼924被容置於軸向開口948之間,且具有一縫線1216附加於引線920上時,縫線1216可自由地沿著橫向開口950通過而不受到阻礙,而縫線1216之位置向外懸垂於橫向開口950。The male suture guide 940 includes a base 946 and a cylindrical shank 942 that is received and supported by a second end 990 of the guiding tool extension arm 982. The cylindrical shank 942 is axially coupled to the base 946. End extension. The shank 942 is configured to releasably attract the lead eye 924. In particular, the shank 942 includes an axially extending opening 948 that has a suitable size for receiving the aperture 924 when the aperture 924 is pushed. The shank 942 also includes a transverse opening 950 that extends across the shank 942 transversely to the shaft The diameter of the opening 948 is made and intersects the axial opening 948. Thus, when the eyelet 924 of the lead 920 is received between the axial openings 948 and has a suture 1216 attached to the lead 920, the suture 1216 is free to pass along the lateral opening 950 without being obstructed. The position of the suture 1216 hangs outwardly from the lateral opening 950.
參照第7圖,細節B,母縫線導引960包括一基座968與一中空圓柱形殼體962,基座968被引導工具加長臂984之第二端990容置與支撐,圓柱形殼體962自基座968之軸向端延伸。殼體962被配置用以容置來自公縫線導引940之尖端922,且可釋放地固定錐形尖端於其中。尤其,殼體962包括一第一殼體開口966,第一殼體開口966係為引線920之錐形尖端穿過所插入的殼體962之內部中空部分,而一第二殼體開口964係為引線920穿過被自殼體962抽出之部分。第一殼體開口966位於殼體之軸向端,實質上為圓柱形且具有小於引線側邊928之直徑。第二殼體開口964位於殼體962之側邊,具有實質上符合引線920之尖端922的尺寸與形狀。在所繪示之實施例中,第二殼體開口964包括一三角形部分,使包括錐形尖端之引線920可穿過並自殼體962中被取出。Referring to Figure 7, detail B, the female suture guide 960 includes a base 968 and a hollow cylindrical housing 962. The base 968 is received and supported by the second end 990 of the guiding tool extension arm 984. Body 962 extends from the axial end of pedestal 968. The housing 962 is configured to receive a tip 922 from the male suture guide 940 and releasably secure the tapered tip therein. In particular, the housing 962 includes a first housing opening 966 such that the tapered tip of the lead 920 passes through the inner hollow portion of the inserted housing 962 and a second housing opening 964 The lead 920 is passed through a portion that is drawn from the housing 962. The first housing opening 966 is located at an axial end of the housing and is substantially cylindrical and has a smaller diameter than the leading side 928 of the lead. The second housing opening 964 is located on a side of the housing 962 having a size and shape that substantially conforms to the tip end 922 of the lead 920. In the illustrated embodiment, the second housing opening 964 includes a triangular portion through which the lead 920 including the tapered tip can pass and be removed from the housing 962.
在使用上,引線被支撐於引導工具980之第一加長臂982上,尤其被固定於公縫線導引940之柄桿942的軸向開口948。公縫線導引940被設置用以支撐引線920,並於移動第一加長臂982與第二加長臂984至引導工具之閉合位置時,傳送引線920至母縫線導引960。在閉合位置,公縫線導引940與母縫線導引960碰觸或幾乎碰觸彼此。 於是,被設置於面對母縫線導引960之公縫線導引940側邊上的引線920,被推進至母縫線導引960中。尤其,當引導工具980移動至閉合位置,尖端922被插入第一殼體開口966,且由頂點926率先插入其中。雖然第一殼體開口966之直徑小於尖端側邊928之外徑,但殼體962於結構上相對較弱,致使引線920之尖端922可穿過第一殼體開口966。由於第一殼體開口966與尖端側邊928尺寸的不同,可防止引線920自殼體962穿過第一開口966被抽出。位於母縫線導引960之殼體962間的引線920,現在被固定於引導工具980之第二加長臂984的第二端990上,當引導工具980張開時,引線920隨著第二加長臂984移動。因此,藉由使用引導工具980,縫線1216可透過附加引線920至公縫線導引940,被固定於第一加長臂982上,接著透過簡單操作引導工具980,使縫線1216可藉由母縫線導引960傳送至第二加長臂984。由於引導工具加長臂982、984符合可設置於椎根螺釘頂部302之間,且每一椎根螺釘頂部302包括軸向延伸開口310、312,在植入椎根螺釘300於脊柱內後,縫線可在皮下與肌下被傳送於相鄰的椎根螺釘300之間。此特徵在使用脊柱固定組件20之方法中是非常重要的,以下將進一步討論。In use, the leads are supported on the first elongate arm 982 of the guiding tool 980, particularly the axial opening 948 of the shank 942 of the male suture leader 940. The male suture guide 940 is configured to support the lead 920 and to transport the lead 920 to the female suture guide 960 when moving the first extension arm 982 and the second extension arm 984 to the closed position of the guiding tool. In the closed position, the male suture guide 940 contacts or nearly touches each other with the female suture guide 960. Thus, the lead 920 disposed on the side of the male stitch guide 940 facing the female stitch guide 960 is advanced into the female stitch guide 960. In particular, when the guiding tool 980 is moved to the closed position, the tip 922 is inserted into the first housing opening 966 and inserted first by the apex 926 therein. While the diameter of the first housing opening 966 is less than the outer diameter of the tip side edge 928, the housing 962 is relatively weak in construction such that the tip end 922 of the lead 920 can pass through the first housing opening 966. Since the first housing opening 966 is different in size from the tip side 928, the lead 920 can be prevented from being withdrawn from the housing 962 through the first opening 966. A lead 920 located between the housing 962 of the female stitch guide 960 is now secured to the second end 990 of the second extension arm 984 of the guiding tool 980. When the guiding tool 980 is opened, the lead 920 follows the second extended arm. 984 moves. Thus, by using the guiding tool 980, the suture 1216 can be affixed to the first elongate arm 982 through the additional lead 920 to the male suture guide 940, and then the suture 1216 can be made by simply operating the guiding tool 980. The female suture guide 960 is delivered to the second extension arm 984. Since the guiding tool extension arms 982, 984 are conformable to be disposed between the pedicle screw tops 302, and each vertebral screw top 302 includes axially extending openings 310, 312, after implantation of the pedicle screw 300 within the spinal column, the suture can be Subcutaneous and submuscular is delivered between adjacent vertebral screws 300. This feature is very important in the method of using the spinal fixation assembly 20, as discussed further below.
參照第8A至8E圖,繪示公縫線導引1340可替代的實施例。舉例來說,在第8A圖中,公縫線導引1340a可形成為與縫線引線為一體,包括設置一基座1346a,用以被支撐於引導工具加長臂982之第二端上,基座1346a包括一開口1342a,縫線可被固定於開口1342a上。公縫線 導引1340a也包括一錐形尖端1322a,用以促使縫線導引1340a插入對應之母縫線導引960的開口。第8B至8E圖繪示其他可替代公縫線導引1340的實施例,其中類似的標號代表了類似的結構。在這些可替代的實施例中,可看見基座1346可被形成為相較於尖端1322,具有較大之外徑(第8B圖)或被形成為非圓柱形(第8B、8D、8E圖)。此外,尖端1322也不限定為圓錐形(第8B、8C、8D圖)。Referring to Figures 8A through 8E, an alternative embodiment of the male suture guide 1340 is illustrated. For example, in FIG. 8A, the male suture guide 1340a can be formed integrally with the suture lead, including a base 1346a for being supported on the second end of the guiding tool extension arm 982. The seat 1346a includes an opening 1342a to which the suture can be secured. Male stitch The guide 1340a also includes a tapered tip 1322a for urging the suture guide 1340a into the opening of the corresponding female suture guide 960. Figures 8B through 8E illustrate other alternative embodiments of the male suture guide 1340, wherein like numerals represent like structures. In these alternative embodiments, it can be seen that the base 1346 can be formed to have a larger outer diameter (Fig. 8B) or a non-cylindrical shape (8B, 8D, 8E) as compared to the tip end 1322. ). Further, the tip end 1322 is not limited to a conical shape (8B, 8C, 8D map).
參照第9A至9D圖,繪示母縫線導引1360可替代的實施例。舉例來說,在第9A圖中,母縫線導引1360a包括設置一基座1362a,用以被支撐於引導工具加長臂984之第二端上。在本實施例中,基座1362a也做為一殼體部分,包括一第一殼體開口1366a與一第二殼體開口1364a,引線尖端922(1322)穿過第一殼體開口1366a插入基座1362a之中空內部,引線920穿過第二殼體開口1364a倍自基座1362a中抽出。第9B至9D圖繪示其他可替代母縫線導引1360的實施例,其中類似的標號代表了類似的結構。在這些可替代的實施例中,可看見第一殼體開口1366與第二殼體開口1364可被形成為不同的形狀(第9B、9C、9D圖),舉例來說符合對應之公縫線導引之結構及/或促使引線插入母縫線導引1360及/或自母縫線導引1360抽出。Referring to Figures 9A through 9D, an alternative embodiment of the female suture guide 1360 is illustrated. For example, in FIG. 9A, the female suture guide 1360a includes a base 1362a for supporting the second end of the guiding tool extension arm 984. In the present embodiment, the base 1362a also serves as a housing portion, including a first housing opening 1366a and a second housing opening 1364a. The lead tip 922 (1322) is inserted through the first housing opening 1366a. In the hollow interior of the seat 1362a, the lead 920 is drawn from the base 1362a through the second housing opening 1364a. Figures 9B through 9D illustrate other alternative embodiments of the female suture guide 1360, wherein like numerals represent like structures. In these alternative embodiments, it can be seen that the first housing opening 1366 and the second housing opening 1364 can be formed into different shapes (9B, 9C, 9D views), for example, corresponding to the male stitch line. The guiding structure and/or the lead is inserted into the female suture guide 1360 and/or extracted from the female suture guide 1360.
參照第10至11圖,微創多功能定位導引鑿子1400被用於準備植入的每一脊椎骨,如下文所述。微創多功能定位導引鑿子1400包括加長的軸桿1402,軸桿1402終止於一握把1420之一端,而另一端結束於一切割尖端1408。切割尖端1408具有鑽頭部分1416及攻牙部分1414,鑽頭 部分1416位於切割部分前端,攻牙部分1414被設置介於鑽頭部分1416與軸桿1402之間。此外,一軸向延伸的通道穿孔1418自握把1420延伸至切割尖端1408,且具有可容納克氏針1200的尺寸。Referring to Figures 10 through 11, a minimally invasive multifunctional positioning guide chisel 1400 is used to prepare each vertebrae implanted, as described below. The minimally invasive multi-function positioning guide chisel 1400 includes an elongated shaft 1402 that terminates at one end of a grip 1420 and ends at a cutting tip 1408. The cutting tip 1408 has a drill portion 1416 and a tapping portion 1414, a drill bit The portion 1416 is located at the front end of the cutting portion, and the tapping portion 1414 is disposed between the drill portion 1416 and the shaft 1402. In addition, an axially extending passage aperture 1418 extends from the grip 1420 to the cutting tip 1408 and has a size that can accommodate the K-wire 1200.
參照第12至39圖,其介紹使用脊柱固定組件20進行微創方法以達到穩定脊柱的一實施例。Referring to Figures 12 through 39, an embodiment of using the spinal fixation assembly 20 for a minimally invasive procedure to achieve stabilization of the spine is described.
第1步驟,將一椎根螺釘300植入每一脊柱2之部分脊椎骨4,用以穩定脊椎骨4(第12至20圖)。椎根螺釘300之植入包括以下步驟:In the first step, a vertebral screw 300 is implanted into a portion of the vertebra 4 of each spine 2 for stabilizing the vertebra 4 (Figs. 12-20). Implantation of the vertebral screw 300 includes the following steps:
步驟1a:提供一切口,切口穿過覆蓋於脊椎骨4上方的皮膚10。一般來說,切口的長度係對應椎根螺釘300之外徑,且由於皮膚的柔韌性,可稍微小於椎根螺釘300之外徑。在繪示之實施例中,椎根螺釘300直徑約為1公分,因此約1公分的切口是必要的,用以容納椎根螺釘300。Step 1a: Provide a slit through which the skin 10 covering the vertebra 4 is placed. In general, the length of the incision corresponds to the outer diameter of the vertebral screw 300 and may be slightly smaller than the outer diameter of the vertebral screw 300 due to the flexibility of the skin. In the illustrated embodiment, the pedicle screw 300 is about 1 cm in diameter, so an incision of about 1 cm is necessary to accommodate the pedicle screw 300.
步驟1b:參照第12圖,藉由在椎根6中形成螺紋孔道,準備讓脊椎骨4容納椎根螺釘300。微創多功能定位導引鑿子1400(詳述於美國對應申請案中,申請號為13/161,698,併入本案中做為參考資料)被插入切口,且被用於定位出椎根6及形成螺紋孔道在其中。使用影像裝置,例如是C型臂(C-Arm)或螢光鏡(fluoroscope),用以確認正確位置。Step 1b: Referring to Figure 12, the vertebra 4 is prepared to receive the pedicle screw 300 by forming a threaded bore in the vertebral root 6. The minimally invasive multi-function positioning guide chisel 1400 (described in detail in the U.S. Patent Application Serial No. 13/161,698, incorporated herein by reference) is inserted into the incision and is used to locate the vertebral root 6 and form a thread. The tunnel is in it. Use an imaging device, such as a C-arm or a fluoroscope, to confirm the correct position.
步驟1c:參照第13圖,插入一克氏針1200,使克氏針1200穿過微創多功能定位導引鑿子之軸向通道穿孔1418且進入脊椎骨4中的欲植入位置。Step 1c: Referring to Figure 13, a Kirschner wire 1200 is inserted to pass the Kirschner wire 1200 through the axial passage perforation 1418 of the minimally invasive multifunctional positioning guide chisel and into the desired implantation site in the vertebra 4.
步驟1d:參照第14圖,自切口移除微創多功能定位導引鑿子1400,留下克氏針1200於適當的位置。Step 1d: Referring to Figure 14, the minimally invasive multi-function positioning guide chisel 1400 is removed from the incision leaving the K-wire 1200 in place.
步驟1e:參照第15至16圖,插入一系列擴張套管1202、1204至克氏針1200上之切口,此些擴張套管始於一相對小直徑的套管1202,且每一接續的套管具有稍微大一些的外直徑。即便這裡僅繪示出兩個套管1202、1204,但可使用六至八個套管以擴張皮膚10、肌肉以及其他在克氏針1200周圍的軟組織,創造空間用以插入椎根螺釘300至身體內(第15圖)。克氏針1200在進行擴張時被用來穩固且對準每一擴張套管1202、1204。在完成擴張後,移除擴張套管1202、1204,留下克氏針1200在適當的位置(第16圖)。Step 1e: Referring to Figures 15 through 16, a series of dilation sleeves 1202, 1204 are inserted into the incisions on the Kirschner wire 1200, the dilatation sleeves starting from a relatively small diameter sleeve 1202, and each successive sleeve The tube has a slightly larger outer diameter. Even though only two cannulas 1202, 1204 are shown here, six to eight cannulas can be used to dilate the skin 10, muscles, and other soft tissue around the K-wire 1200, creating space for insertion of the pedicle screw 300 to the body. Inside (figure 15). The K-wire 1200 is used to stabilize and align each expansion sleeve 1202, 1204 as it expands. After the expansion is completed, the expansion sleeves 1202, 1204 are removed leaving the K-wire 1200 in place (Fig. 16).
步驟1f:參照第17至18圖,沿著克氏針1200植入椎根螺釘300至脊椎骨的預先攻牙的螺紋孔道中。具體地說,椎根螺釘300被裝載於克氏針1200上,使克氏針1200被容納於柄部之軸向通道穿孔350與椎根螺釘之頂部302的內部空間中。克氏針1200用來穩固與對齊椎根螺釘之柄部344,使柄部344上之螺紋348嚙合且旋緊於螺紋孔道上。在繪示之實施例中,一驅動工具被用來旋轉椎根螺釘300,旋緊椎根螺釘至脊椎骨4之孔道中。如圖式所示,當柄部344完全被旋緊至脊椎骨4,椎根螺釘之頂部302之一部分相較於皮膚10突出於切口之外部。Step 1f: Referring to Figures 17 to 18, the pedicle screw 300 is implanted along the K-wire 1200 into the pre-tapping threaded bore of the vertebra. Specifically, the pedicle screw 300 is loaded onto the Kirschner wire 1200 such that the Kirschner wire 1200 is received in the axial passage perforation 350 of the handle and the interior space of the top 302 of the pedicle screw. The Kirschner wire 1200 is used to stabilize and align the shank 344 of the pedicle screw such that the threads 348 on the handle 344 engage and screw onto the threaded bore. In the illustrated embodiment, a drive tool is used to rotate the pedicle screw 300 and tighten the pedicle screw into the bore of the vertebra 4. As shown, when the handle 344 is fully screwed to the vertebra 4, a portion of the top 302 of the vertebral screw protrudes outside of the incision than the skin 10.
步驟1g:參照第19圖,自切口移除驅動工具與克氏針1200,留下椎根螺釘300在適當的位置。Step 1g: Referring to Figure 19, the drive tool is removed from the incision with the Kirschner wire 1200, leaving the pedicle screw 300 in place.
步驟1h:參照第20圖,重複前述植入椎根螺釘 300之步驟1a至1g,用以穩固每一脊椎骨4。在繪示之實施例中,藉由椎根螺釘(300a、300b、300c、300d)植入四根脊椎骨4之每一根脊椎骨,四根脊椎骨4都被穩固。Step 1h: Repeat the aforementioned implantation of vertebral screws with reference to Fig. 20. Steps 1a to 1g of 300 are used to stabilize each vertebra 4. In the illustrated embodiment, each of the four vertebrae 4 is implanted by vertebral screws (300a, 300b, 300c, 300d), and the four vertebrae 4 are stabilized.
參照第21圖,第2步驟包括使用一對準工具1214對準個別椎根螺釘之頂部302,使椎根螺釘300之縱向軸彼此平行且各椎根螺釘300彼此垂直對齊。在第21圖中,一參考座標被定義為x軸實質上對應於脊柱2之縱向軸且位於水平方向,y軸橫向並垂直於x軸,且對應於脊柱2之前後方向。在第2步驟中,個別之椎根螺釘頂部302彼此對齊,使第一、第二椎根螺釘開口310、312沿著x軸開啟,因此個別椎根螺釘之橫向開口318對齊於x軸。Referring to Fig. 21, the second step includes aligning the tops 302 of the individual vertebral screws with an alignment tool 1214 such that the longitudinal axes of the pedicle screws 300 are parallel to each other and the vertebral screws 300 are vertically aligned with each other. In Fig. 21, a reference coordinate is defined such that the x-axis substantially corresponds to the longitudinal axis of the spine 2 and is in the horizontal direction, the y-axis is transverse and perpendicular to the x-axis, and corresponds to the front and rear directions of the spine 2. In the second step, the individual vertebral screw tips 302 are aligned with each other such that the first and second vertebral screw openings 310, 312 are opened along the x-axis such that the lateral opening 318 of the individual vertebral screws is aligned with the x-axis.
第3步驟包括藉由皮下穿過一縫線1216通過個別椎根螺釘頂部302,以連結椎根螺釘300。連結椎根螺釘300包括以下步驟:The third step includes joining the pedicle screws 300 by subcutaneously passing through a suture 1216 through the individual pedicle screw tops 302. Connecting the pedicle screw 300 includes the following steps:
步驟3a:參照第22至23圖,使用縫線引導工具980將縫線1216插入椎根螺釘300a之最頂部,使縫線之前端從頂部之第二端308至第一端306,穿過椎根螺釘之頂部302之內部空間(舉例來說沿著y軸進行)。Step 3a: Referring to Figures 22 to 23, the suture 1216 is inserted into the topmost portion of the vertebral screw 300a using the suture guiding tool 980 such that the front end of the suture passes from the second end 308 of the top to the first end 306, through the pedicle screw The interior space of the top 302 (for example, along the y-axis).
步驟3b:參照第24至25圖,啟動引導工具980,將縫線1216自椎根螺釘300a頂部之第一端306,沿著x軸引導至相鄰的椎根螺釘300b,且使其實質上平行於脊柱2之縱向軸。尤其,藉由引線920自公縫線導引940至母縫線導引960(第24圖),啟動引導工具980從張開位置至閉合位置,使縫線1216於相鄰的椎根螺釘300a、300b之間被傳送。縫線1216接著藉由啟動縫線導引至張開位 置,被移動至相鄰的椎根螺釘300b。Step 3b: Referring to Figures 24 through 25, the guiding tool 980 is activated to guide the suture 1216 from the first end 306 of the top of the vertebral screw 300a, along the x-axis to the adjacent vertebral screw 300b, and to make it substantially parallel to The longitudinal axis of the spine 2. In particular, by the lead 920 from the male suture guide 940 to the female suture guide 960 (Fig. 24), the guiding tool 980 is activated from the open position to the closed position, with the suture 1216 adjacent the pedicle screws 300a, 300b. Transferred between. The suture 1216 is then guided to the open position by the activation suture It is moved to the adjacent pedicle screw 300b.
步驟3c:參照第26圖,縫線引導工具980自椎根螺釘300a、300b頂部中抽出,縫線1216此時連接椎根螺釘300a最頂部與相鄰之椎根螺釘300b。這時候,引線920被傳送回公縫線導引940,準備在椎根螺釘300b及300c中再次施行步驟3a至3b。Step 3c: Referring to Figure 26, the suture guiding tool 980 is withdrawn from the top of the vertebral screws 300a, 300b, and the suture 1216 is now attached to the topmost of the vertebral screws 300a and the adjacent vertebral screws 300b. At this time, the lead wire 920 is conveyed back to the male suture guide 940, and steps 3a to 3b are prepared to be performed again in the vertebral screws 300b and 300c.
步驟3d:參照第27圖,重複步驟3a至3c直到每一椎根螺釘300a、300b、300c、300d藉由縫線1216於皮下與肌下串接。雖然連結步驟揭示從300a之最頂部至300d之最頂部,但並不限制於此。舉例來說,此方法可包括從椎根螺釘300之最尾部至最頂部進行。Step 3d: Referring to Figure 27, steps 3a through 3c are repeated until each vertebral screw 300a, 300b, 300c, 300d is subcutaneously subcutaneously connected to the muscle by suture 1216. Although the joining step reveals from the top of 300a to the top of 300d, it is not limited thereto. For example, the method can include performing from the extreme tail to the top of the vertebral screw 300.
第4步驟包括將縫線前端1216a穿過小通道切口(1公分或小於1公分),將縫線前端1216a自身體抽出。小通道切口就椎根螺釘300d之最尾端而言位於尾端的位置。抽出縫線包括以下步驟:The fourth step includes passing the suture front end 1216a through the small passage slit (1 cm or less) and withdrawing the suture front end 1216a itself. The small channel incision is located at the end of the apical screw 300d. Pulling out the suture includes the following steps:
步驟4a:參照第28至29圖,提供一圓規工具1218,用以將縫線1216自身體抽出。圓規工具1218包括一基腳1220與一彎曲旋轉腳1222,基腳1220被配置用以持有縫線引線920,彎曲旋轉腳1222被配置用以接受縫線引線920,並以基腳1220之一端為旋轉軸,使縫線引線920相對於基腳1220旋轉。如第28圖所示,基腳1220持有相鄰於椎根螺釘300之縫線引線920。在隨後的步驟中,基腳1220插入椎根螺釘300d之最尾端,而旋轉腳1222相較於基腳1220旋轉(圖中為順時針方向),使得旋轉腳1222穿過通道切口。於是,縫線引線920自基腳1220之 一端移動至旋轉腳1222之一端,此方式類似於縫線導引組件900之使用。旋轉腳1222接著相對於基腳1220旋轉(圖中為逆時針方向),用以將縫線1216自通道切口抽出(第29圖)。Step 4a: Referring to Figures 28 through 29, a compass tool 1218 is provided for withdrawing the suture 1216 itself. The compass tool 1218 includes a footing 1220 and a curved swivel leg 1222 that is configured to hold a suture lead 920 that is configured to receive the suture lead 920 and one end of the footing 1220 For the axis of rotation, the suture lead 920 is rotated relative to the footing 1220. As shown in FIG. 28, the footing 1220 holds a suture lead 920 adjacent the pedicle screw 300. In a subsequent step, the footing 1220 is inserted into the extreme end of the pedicle screw 300d, and the rotating foot 1222 is rotated relative to the footing 1220 (clockwise in the figure) such that the rotating foot 1222 passes through the channel incision. Thus, the suture lead 920 is from the base 1220 One end moves to one end of the swivel foot 1222 in a manner similar to the use of the suture leader assembly 900. The swivel foot 1222 is then rotated relative to the footing 1220 (counterclockwise in the figure) for withdrawing the suture 1216 from the channel incision (Fig. 29).
參照第30及31圖,第5步驟包括提供一固定棒200。尤其,固定棒200至少具有同時跨越所有植入的椎根螺釘300a至300d的長度。在某些實施例中,個別突出的椎根螺釘第二端308可當作樣板,用以切割一預定之儲備長度(第30圖)。此外,固定棒200可具有對應於脊柱2之彎曲(虛線所繪示)。尤其,固定棒200之彎曲可藉由對應椎根螺釘300之第二端上表面所定義的線,彎曲固定棒200,在植入身體之前於體外調整。Referring to Figures 30 and 31, the fifth step includes providing a fixed rod 200. In particular, the fixation rod 200 has at least a length that spans all of the implanted pedicle screws 300a to 300d at the same time. In some embodiments, the individual protruding pedicle screw second end 308 can serve as a template for cutting a predetermined reserve length (Fig. 30). Further, the fixed rod 200 may have a curvature corresponding to the spine 2 (shown by a broken line). In particular, the bending of the fixation rod 200 can be flexed by the line defined by the upper surface of the second end of the vertebral screw 300 to be adjusted externally prior to implantation into the body.
參照第32圖,第6步驟包括藉由將縫線1216穿過固定棒200的中空內通道,使尺寸與形狀符合的固定棒200穿過皮下與肌下並包於縫線1216之外。Referring to Fig. 32, the sixth step includes passing the suture 1216 through the hollow inner passage of the fixation rod 200 such that the size and shape of the fixation rod 200 passes under the skin and under the muscle and wraps around the suture 1216.
第7步驟包括沿著縫線1216傳送固定棒200至身體內並穿過每一個別之椎根螺釘頂部302,使固定棒200座落於橫向通道316中,橫向通道316相鄰於每一個別之椎根螺釘頂部302的第一端306。The seventh step includes transporting the fixation rod 200 along the suture 1216 into the body and through each individual vertebral screw top 302 such that the fixation rod 200 is seated in the transverse channel 316 adjacent to each individual The first end 306 of the apical screw top 302.
第8步驟包括將縫線1216自身體移除,留下固定棒200於一系列椎根螺釘300之間。The eighth step includes removing the suture 1216 body itself, leaving the fixation rod 200 between a series of pedicle screws 300.
第9步驟包括將固定棒200拴牢於每一椎根螺釘300上。以下步驟用以將固定棒200拴牢於一椎根螺釘300:The ninth step includes securing the fixation rod 200 to each of the vertebral screws 300. The following steps are used to secure the fixation rod 200 to a vertebral screw 300:
步驟9a:參照第33圖,藉由拴牢帽蓋600至椎根螺釘頂部第二端308,使固定棒200穩固於椎根螺釘 300,接著插入穩固工具700,使穩固工具700穿過帽蓋600且至椎根螺釘頂部302。裝配完成後,穩固工具腳712穩固地座落於固定棒200上,固定棒200位於椎根螺釘之頂部302之第一與第二開口310、312之最底部分之間,且在之後的步驟(9b)中維持固定棒200的位置。Step 9a: Referring to Figure 33, the fixation rod 200 is secured to the pedicle screw by the cap 600 to the apical screw top second end 308 300, followed by insertion of the stabilization tool 700, the stabilization tool 700 is passed through the cap 600 and to the pedicle screw top 302. After assembly is complete, the stabilizing tool foot 712 is securely seated on the fixed rod 200 between the first and second openings 310, 312 of the top 302 of the vertebral screw, and in a subsequent step ( The position of the fixed rod 200 is maintained in 9b).
步驟9b:參照第34圖,利用促動器850驅動扣件500進入椎根螺釘之頂部302,用以讓固定棒200穩固於椎根螺釘300,使得扣件500之外螺紋508嚙合於對應之螺紋326,螺紋326位於椎根螺釘之頂部302之內表面上。於是,固定棒200維持於扣件500與椎根螺釘300之第一端306之間。Step 9b: Referring to Figure 34, the fastener 500 is used to drive the fastener 500 into the top 302 of the vertebral screw for securing the fixation rod 200 to the vertebral screw 300 such that the external thread 508 of the fastener 500 engages the corresponding thread 326. The thread 326 is located on the inner surface of the top 302 of the vertebral screw. Thus, the fixation rod 200 is maintained between the fastener 500 and the first end 306 of the pedicle screw 300.
步驟9c:參照第35、36圖,重複步驟9a至9b直到固定棒200穩固於每一椎根螺釘300a至300d。Step 9c: Referring to Figures 35 and 36, steps 9a to 9b are repeated until the fixation rod 200 is secured to each of the vertebral screws 300a to 300d.
第10步驟包括自每一椎根螺釘之頂部302之維持器移除椎根螺釘之頂部的背側部324。移除步驟包括以下步驟:The 10th step includes removing the dorsal portion 324 of the top of the pedicle screw from the holder of the top 302 of each vertebral screw. The removal step includes the following steps:
步驟10a:參照第37至38圖,使用螺釘斷裂工具800施加一扭力於背側部324,使得背側部324沿著一環狀分離區域318自椎根螺釘之第一端分離,並自身體抽出分離的背側部324。Step 10a: Referring to Figures 37 to 38, a torque is applied to the dorsal portion 324 using the screw breaking tool 800 such that the dorsal portion 324 separates from the first end of the vertebral screw along an annular separation region 318 and is extracted by itself. Separate back side portion 324.
第11步驟包括縫合所有微創切口。The 11th step involves suturing all minimally invasive incisions.
綜上所述,雖然本發明已以較佳實施例揭露如上,然其並非用以限定本發明。本發明所屬技術領域中具有通常知識者,在不脫離本發明之精神和範圍內,當可作各種之 更動與潤飾。因此,本發明之保護範圍當視後附之申請專利範圍所界定者為準。In conclusion, the present invention has been disclosed in the above preferred embodiments, and is not intended to limit the present invention. Those having ordinary skill in the art to which the present invention pertains can be made in various ways without departing from the spirit and scope of the invention. Change and retouch. Therefore, the scope of the invention is defined by the scope of the appended claims.
2‧‧‧脊柱2‧‧‧Spine
4‧‧‧脊椎骨4‧‧‧ vertebrae
6‧‧‧椎根6‧‧‧ vertebral root
8‧‧‧椎間盤8‧‧‧Intervertebral disc
10‧‧‧皮膚10‧‧‧ skin
20‧‧‧脊柱固定組件20‧‧‧ Spinal fixation components
200‧‧‧固定棒200‧‧‧Fixed rod
210‧‧‧內通道210‧‧‧Internal passage
212、306、502、602、702、802、856、988‧‧‧第一端212, 306, 502, 602, 702, 802, 856, 988‧‧‧ first end
214、308、604、704、804、858、990、990’‧‧‧第二端214, 308, 604, 704, 804, 858, 990, 990'‧‧‧ second end
300‧‧‧椎根螺釘300‧‧‧ pedicle screw
302‧‧‧頂部302‧‧‧ top
304‧‧‧螺紋端304‧‧‧Threaded end
310、312、612、614、708、710、948、950、964、966、1342a、1364、1364a、1366、1366a‧‧‧開口310, 312, 612, 614, 708, 710, 948, 950, 964, 966, 1342a, 1364, 1364a, 1366, 1366a‧‧
316、616‧‧‧穿越通道316, 616‧‧‧ crossing passage
318‧‧‧分離區域318‧‧‧Separation area
320、332、718、814、818、1422‧‧‧溝槽320, 332, 718, 814, 818, 1422‧‧‧ trenches
322‧‧‧腹側部322‧‧‧ ventral side
324‧‧‧背側部324‧‧‧ Back side
326、348、508、1426、1430‧‧‧螺紋326, 348, 508, 1426, 1430‧‧ thread
342‧‧‧基底342‧‧‧Base
344、854‧‧‧柄部344, 854‧‧ ‧ handle
346‧‧‧頂端346‧‧‧Top
350、1418‧‧‧通道穿孔350, 1418‧‧‧ channel perforation
500‧‧‧扣件500‧‧‧fasteners
506‧‧‧外表面506‧‧‧ outer surface
510‧‧‧管座510‧‧‧Tube
600、1428‧‧‧帽蓋600, 1428‧‧‧ caps
606、706、806‧‧‧側壁606, 706, 806‧‧‧ side walls
610‧‧‧環狀隆起610‧‧‧Round bulge
618、812‧‧‧中央開口618, 812‧‧‧ central opening
622‧‧‧中央部分622‧‧‧Central Part
624‧‧‧細長部分624‧‧‧Slim part
700‧‧‧穩固工具700‧‧‧Steady tools
712‧‧‧穩固工具腳712‧‧‧Sturdy tool feet
714‧‧‧基底部分714‧‧‧base part
716‧‧‧握把部分716‧‧‧ grip part
800‧‧‧螺釘斷裂工具800‧‧‧screw breaking tool
810‧‧‧握把區域810‧‧‧ grip area
820、1202、1204‧‧‧套管820, 1202, 1204‧‧‧ casing
850‧‧‧促動器850‧‧‧Actuator
852、1420‧‧‧握把852, 1420‧‧ ‧ grip
890‧‧‧喇叭形部分890‧‧‧ flared section
892‧‧‧定型部分892‧‧‧ stereotypes
900‧‧‧縫線導引組件900‧‧‧Sewing guide assembly
920‧‧‧引線920‧‧‧ lead
922、1322、1322a‧‧‧尖端922, 1322, 1322a‧‧‧ cutting-edge
924‧‧‧孔眼924‧‧ ‧ eyelet
926‧‧‧頂點Vertex 926‧‧‧
928‧‧‧側邊928‧‧‧ side
940、960、1340、1340a、1340b、1340c、1340d、1360a、1360b、1360c、1360d‧‧‧縫線導引940, 960, 1340, 1340a, 1340b, 1340c, 1340d, 1360a, 1360b, 1360c, 1360d‧‧‧ suture guidance
942‧‧‧柄桿942‧‧‧handle
946、968、1346、1346a、1362a‧‧‧基座946, 968, 1346, 1346a, 1362a‧‧ pedestal
962‧‧‧殼體962‧‧‧Shell
980‧‧‧引導工具980‧‧‧Guide Tools
982、982’、984、984’‧‧‧加長臂982, 982’, 984, 984’ ‧ ‧ long arms
992、992’‧‧‧指環992, 992’ ‧ ‧ ring
986‧‧‧樞軸銷986‧‧‧ pivot pin
1200‧‧‧克氏針1200‧‧‧Kerns needle
1216‧‧‧縫線1216‧‧‧ stitching
1216a‧‧‧前端1216a‧‧‧ front end
1218‧‧‧圓規工具1218‧‧‧ compass tool
1220‧‧‧基腳1220‧‧‧ footing
1222‧‧‧旋轉腳1222‧‧‧Rotating feet
1400‧‧‧微創多功能定位導引鑿子1400‧‧‧ minimally invasive multi-function positioning guide chisel
1402‧‧‧軸桿1402‧‧‧ shaft
1408‧‧‧切割尖端1408‧‧‧ cutting tip
1414‧‧‧攻牙部分1414‧‧‧Tapping section
1416‧‧‧鑽頭部分1416‧‧‧Drill part
第1A-1D圖繪示修復椎間盤突出的步驟。Figures 1A-1D illustrate the steps of repairing the herniated disc.
第2圖繪示一種被植入一系列四個相鄰脊椎骨之微創脊柱固定組件的透視圖。Figure 2 is a perspective view of a minimally invasive spinal fixation assembly implanted in a series of four adjacent vertebrae.
第3圖繪示在第2圖之脊柱固定組件中使用之固定棒的側視圖。Figure 3 is a side elevational view of the fixation rod used in the spinal fixation assembly of Figure 2.
第4圖繪示椎根螺釘組件,包括在第2圖之脊柱固定組件中使用之椎根螺釘、帽蓋及穩固工具的分解透視圖。Figure 4 is a perspective view of the vertebral screw assembly including the pedicle screw, cap and stabilizing tool used in the spinal fixation assembly of Figure 2.
第4A圖繪示第4圖中沿著4a-4a剖面線之椎根螺釘組件的剖面圖。Figure 4A is a cross-sectional view of the vertebral screw assembly along section line 4a-4a in Figure 4.
第5圖繪示在第2圖之脊柱固定組件中使用之扣件的透視圖。Figure 5 is a perspective view of the fastener used in the spinal fixation assembly of Figure 2.
第6A圖繪示在植入第2圖之脊柱固定組件時使用之斷裂工具的分解圖。Figure 6A is an exploded view of the fracture tool used in implanting the spinal fixation assembly of Figure 2.
第6B圖繪示在第6A圖中斷裂工具被標示為6B的部分之放大圖。Fig. 6B is an enlarged view showing a portion of the fracture tool designated as 6B in Fig. 6A.
第6C圖繪示使用斷裂工具分離椎根螺釘之頂部為兩部分的示意圖。Figure 6C is a schematic view showing the use of a fracture tool to separate the top of the pedicle screw into two parts.
第7圖繪示引導工具組件的透視圖。Figure 7 shows a perspective view of the guiding tool assembly.
第8A-8E圖繪示第7圖中引導工具組件之公縫線導引的可替代實施例。8A-8E illustrate an alternate embodiment of the male suture guide of the guide tool assembly of FIG.
第9A-9D圖繪示第7圖中引導工具組件之母縫線導引 的可替代實施例。Figure 9A-9D shows the mother stitch guide of the guiding tool assembly in Fig. 7. An alternative embodiment.
第10圖繪示植入第2圖中脊椎固定系統所使用之微創多功能定位導引鑿子的側視圖。Figure 10 is a side elevational view of the minimally invasive multi-function positioning guide chisel used in the spinal fixation system of Figure 2.
第11圖繪示第10圖中微創多功能定位導引鑿子之尖端的細部放大圖。Figure 11 is a detailed enlarged view of the tip of the minimally invasive multifunctional positioning guide chisel in Figure 10.
第12-14圖繪示使用微創多功能定位導引鑿子形成一椎根螺釘孔洞並植入克式針至脊椎骨的示意圖。Figures 12-14 illustrate schematic views of the use of a minimally invasive multifunctional positioning guide chisel to form a vertebral screw hole and implant a gram needle into the vertebra.
第15圖繪示在克式針附近之軟組織的擴張。Figure 15 depicts the expansion of soft tissue near the gram needle.
第16圖繪示擴張完成並移除擴張套管後,將克式針保留在適當的位置。Figure 16 shows the gram needle in place after expansion is complete and the expansion cannula is removed.
第17圖繪示將椎根螺釘沿著克式針插入體內。Figure 17 depicts the insertion of a vertebral screw along the gram needle.
第18-19圖繪示植入椎根螺釘於脊椎骨中。Figures 18-19 illustrate the implantation of vertebral screws in the vertebrae.
第20圖繪示重複椎根螺釘植入步驟,將椎根螺釘植入多數根相鄰的脊椎骨。Figure 20 depicts a repeating pedicle screw implantation procedure in which a pedicle screw is implanted into a plurality of adjacent vertebrae.
第21圖繪示使用對準工具對準椎根螺釘頂部。Figure 21 illustrates the alignment of the apical screw top with an alignment tool.
第22-29圖繪示使用導引工具組件將一縫線穿過皮下與肌下至植入的椎根螺釘頂部個別的第一端。Figures 22-29 illustrate the use of a guide tool assembly to pass a suture through the subcutaneous and subcutaneous muscles to the individual first end of the implanted pedicle screw.
第30-31圖繪示以椎根螺釘暴露體外的部份為模板,用以在植入前將椎根螺釘固定棒預先定型。Figures 30-31 illustrate the portion of the vertebral screw exposed to the template for pre-positioning the vertebral screw fixation rod prior to implantation.
第32圖繪示將固定棒沿著縫線穿過個別植入之椎根螺釘頂部。Figure 32 illustrates the placement of the fixation rod along the suture through the top of the individually implanted vertebral screw.
第33圖繪示裝配一帽蓋與穩定器於椎根螺釘頂部之上。Figure 33 shows the assembly of a cap and stabilizer on top of the vertebral screw.
第34圖繪示植入一扣件,使扣件通過帽蓋與穩定器以固定椎根螺釘之固定棒。Figure 34 illustrates the attachment of a fastener to the fastener through the cap and stabilizer to secure the pedicle screw.
第35圖繪示重複第34圖之步驟於每一椎根螺釘上。Figure 35 depicts the steps of repeating Figure 34 on each vertebral screw.
第36-37圖繪示使用斷裂工具使每一椎根螺釘頂部之背側部斷裂。Figures 36-37 illustrate the use of a fracture tool to break the dorsal portion of the top of each vertebral screw.
第38圖繪示植入脊柱固定組件。Figure 38 depicts the implanted spinal fixation assembly.
第39圖繪示引導工具組件之另一實施例的透視圖。Figure 39 illustrates a perspective view of another embodiment of a guide tool assembly.
2‧‧‧脊柱2‧‧‧Spine
4‧‧‧脊椎骨4‧‧‧ vertebrae
20‧‧‧脊柱固定組件20‧‧‧ Spinal fixation components
200‧‧‧固定棒200‧‧‧Fixed rod
300‧‧‧椎根螺釘300‧‧‧ pedicle screw
Claims (26)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US13/161,686 US8784424B2 (en) | 2011-06-16 | 2011-06-16 | Minimally invasive spinal stabilization system |
US13/161,705 US8870879B2 (en) | 2011-06-16 | 2011-06-16 | Minimally invasive spinal stabilization method |
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TW201300073A TW201300073A (en) | 2013-01-01 |
TWI468143B true TWI468143B (en) | 2015-01-11 |
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TW100147514A TWI468143B (en) | 2011-06-16 | 2011-12-20 | Minimally invasive spinal stabilization system |
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DE102013110796A1 (en) * | 2013-09-30 | 2015-04-02 | Z-Medical Gmbh & Co. Kg | Surgical instrument |
CN112587187B (en) * | 2019-09-17 | 2024-07-12 | 尚品医疗器材股份有限公司 | Minimally invasive vertebral annulus repair device |
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US5730747A (en) * | 1995-06-07 | 1998-03-24 | Smith & Nephew, Inc. | Suture passing forceps |
US20030149431A1 (en) * | 2002-02-01 | 2003-08-07 | Varieur Michael S. | Closure system for spinal fixation instrumentation |
US20080114403A1 (en) * | 2006-11-09 | 2008-05-15 | Zimmer Spine, Inc. | Minimally invasive pedicle screw access system and associated method |
US20080234759A1 (en) * | 2005-04-27 | 2008-09-25 | Trinity Orthopedics, Llc | Mono-Planar Pedicle Screw Method, System and Kit |
US20080312704A1 (en) * | 2007-06-12 | 2008-12-18 | Zimmer Spine, Inc. | Instrumentation and associated techniques for minimally invasive spinal construct installation |
US20090171392A1 (en) * | 2007-12-04 | 2009-07-02 | Javier Garcia-Bengochea | Guide wire mounting collar for spinal fixation using minimally invasive surgical techniques |
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US5730747A (en) * | 1995-06-07 | 1998-03-24 | Smith & Nephew, Inc. | Suture passing forceps |
US20030149431A1 (en) * | 2002-02-01 | 2003-08-07 | Varieur Michael S. | Closure system for spinal fixation instrumentation |
US20080234759A1 (en) * | 2005-04-27 | 2008-09-25 | Trinity Orthopedics, Llc | Mono-Planar Pedicle Screw Method, System and Kit |
US20080114403A1 (en) * | 2006-11-09 | 2008-05-15 | Zimmer Spine, Inc. | Minimally invasive pedicle screw access system and associated method |
US20080312704A1 (en) * | 2007-06-12 | 2008-12-18 | Zimmer Spine, Inc. | Instrumentation and associated techniques for minimally invasive spinal construct installation |
US20090171392A1 (en) * | 2007-12-04 | 2009-07-02 | Javier Garcia-Bengochea | Guide wire mounting collar for spinal fixation using minimally invasive surgical techniques |
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