図1は本発明の一実施形態(実施例1)の椎体間固定外科手術システムの主要構成概念を示す縦断面図(主要部断面)、図2は本発明の実施例1の椎体間固定装置10の概念を示す縦断面図(主要部断面)、図3は図2のA-A矢視断面図、図4(a)、(b)はそれぞれ図2のB-B矢視断面図、C-C矢視断面図、図5(a)、(b)、(c)、(d)、(e)、(f)はそれぞれ本発明の別の変形実施形態のピンの概念を示す一部断面図、図6は図2のD-D矢視断面図、図7は図2の平面図、図8は椎体間固定装置10の椎体L1、L2間への嵌入状態を示す縦断面図(主要部断面)、図9は椎体間固定装置10の椎体L1、L2間への固定完了状態を示す縦断面図(主要部断面)、図10は図9のE-E矢視図である。なお、ここに添付した図面は、いずれも内部構造を分かり易くするため軸方向に比べて径方向を拡大してノットスケールで表現された主要構成概念を示す概念図である。FIG. 1 is a longitudinal sectional view (main section) showing a main configuration concept of an interbody fusion surgical system according to an embodiment (Example 1) of the present invention, and FIG. 2 is an intervertebral body of Example 1 of the present invention. FIG. 3 is a sectional view taken along the line AA in FIG. 2, and FIGS. 4A and 4B are sectional views taken along the line BB in FIG. FIGS. 5A, 5B, 5C, 5C, 5D, 5E, 5F, and 5F are cross-sectional views taken along arrows CC, respectively. 6 is a cross-sectional view taken along the line DD of FIG. 2, FIG. 7 is a plan view of FIG. 2, and FIG. 8 is a diagram showing a state where theinterbody fusion device 10 is inserted between the vertebral bodies L1 and L2. 9 is a longitudinal sectional view (cross section of the main part), FIG. 9 is a longitudinal sectional view (cross section of the main part) showing a state of fixation between the vertebral bodies L1 and L2 of theinterbody fusion device 10, and FIG. FIG. Each drawing attached here is a conceptual diagram showing the main structural concept expressed in knot scale by enlarging the radial direction compared to the axial direction in order to make the internal structure easy to understand.
本発明の一実施形態の椎体間固定外科手術システムは、図1に示すように、前端有底の略中空円筒状の外面に椎体L1、L2間に係合して嵌入される雄ねじ状の外面係合部14、15が形成され、後端側中空内面16aに設けられた雌ねじ16内面から椎体方向に末広がりに外面まで貫通する1つ又は複数のガイド孔17、18が穿設された本体11、ガイド孔内に遊嵌収容された1つ又は複数のピン30、及び雌ねじ16に螺合しピン後端を押圧してピンの先端側をガイド孔に沿って椎体内に差込む押圧ねじ40を有し、2つの隣接する椎体(椎骨)L1、L2間の椎間板スペースMに嵌入して椎体L1、L2を固定する椎体間固定装置10と、椎体間固定装置10を椎体L1、L2間に移植固定するのに先立ち、生体例えば人体MNの腹部MN1側から椎体L1、L2間の中心に向けて穿設された内視鏡用ポートMa内に挿入されるカニューレKと、カニューレK内に挿入し、椎体L1、L2間の適正な間隔を修正して椎間板スペースMを保持するための椎体間スペース保持装置70と、先端係合部83に椎体間固定装置10の本体11の後端係合部29に係合した状態で椎体間スペース保持装置70の中空部内に挿入し、本体11を押圧し回転して椎体L1、L2間に嵌入させる本体嵌入ドライバー80と、先端係合部93に椎体間固定装置10の押圧ねじ40の後端係合部44に係合した状態で本体嵌入ドライバー80の中空内に挿入し、押圧ねじ40を本体11の雌ねじ部16に挿入し押圧しながら螺入させる押圧ねじドライバー90と、を具備する。As shown in FIG. 1, the interbody fusion surgical system according to an embodiment of the present invention is a male screw shape that is engaged and fitted between vertebral bodies L1 and L2 on a substantially hollow cylindrical outer surface having a front end. Outersurface engaging portions 14 and 15 are formed, and one or a plurality of guide holes 17 and 18 penetrating from the inner surface of thefemale screw 16 provided on the rear end side hollowinner surface 16a to the outer surface so as to extend toward the vertebral body are formed. Themain body 11, one or a plurality ofpins 30 loosely accommodated in the guide hole, and thefemale screw 16 are screwed together and the rear end of the pin is pressed so that the distal end side of the pin is inserted into the vertebral body along the guide hole. An intervertebralbody fixing device 10 that has apressing screw 40 to be inserted and fits into an intervertebral disc space M between two adjacent vertebral bodies (vertebrae) L1 and L2, and fixes the vertebral bodies L1 and L2. Prior to transplantation and fixation of 10 between the vertebral bodies L1 and L2, A cannula K inserted into the endoscope port Ma drilled from the side of the part MN1 toward the center between the vertebral bodies L1 and L2, and inserted into the cannula K, and an appropriate distance between the vertebral bodies L1 and L2 In a state where the intervertebralspace holding device 70 for holding the intervertebral disc space M by correcting the interval and the distalend engaging portion 83 engaged with the rearend engaging portion 29 of themain body 11 of theinterbody fixing device 10. Theinterbody fixing device 10 is inserted into the hollow portion of the interbodyspace holding device 70, themain body 11 is pressed and rotated to be inserted between the vertebral bodies L1 and L2, and the intervertebralbody fixing device 10 is inserted into the distalend engaging portion 93. Apress screw driver 90 is inserted into the hollow of the mainbody insertion driver 80 in a state of being engaged with the rearend engaging portion 44 of thepress screw 40, and thepress screw 40 is inserted into thefemale screw portion 16 of themain body 11 and screwed while being pressed. And.
さらに、椎体間固定外科手術の際に観察及び各種事前/事後の処置をするため、いずれも図示しない別途複数の内視鏡用腹腔から挿入される内視鏡(又は腹腔鏡)あるいは本体嵌入ドライバー80中空内に収設されるカプセル内視鏡等を備えることが望ましい。Furthermore, in order to perform observation and various pre / post treatments during interbody fusion surgery, an endoscope (or a laparoscope) or a main body is inserted through a plurality of endoscope abdominal cavity (not shown). It is desirable to provide a capsule endoscope or the like housed in the hollow of thedriver 80.
本発明の実施例1の椎体間固定装置10は、椎体L1、L2間の適正な間隔に適合する前端有底の略中空円筒状に形成され、外面に椎体L1、L2の対向面L1a、L2a部に外面頭頂部が係合して嵌入される雄ねじ状の外面係合部14、15が形成された本体11と、本体11の後端面13側の中空内面16aに形成された雌ねじ16と、雌ねじ16の奥行き部から椎体L1、L2の対向面L1a、L2aに向かって径方向に略軸対称な末広がりに傾斜して外面まで貫通し穿設された1対のガイド孔17、18と、雌ねじ16内に本体11の主軸C1に沿って遊嵌収容され、先端32側がそれぞれ1対のガイド孔17、18に沿って案内され屈曲し挿通された1対のピン30、30と、雌ねじ16に螺合しその軸方向推進力により、ピン30、30の後端31、31を押圧する押圧ねじ40と、から概略構成されている。Theinterbody fusion device 10 according to the first embodiment of the present invention is formed in a substantially hollow cylindrical shape with a front end that fits an appropriate distance between the vertebral bodies L1 and L2, and the opposing surface of the vertebral bodies L1 and L2 on the outer surface. Amain body 11 formed with externalthread engaging parts 14 and 15 into which outer surface tops engage with L1a and L2a parts, and a female thread formed on a hollowinner surface 16a on the rear end face 13 side of themain body 11 16 and a pair of guide holes 17 inclined from the depth of thefemale screw 16 toward the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2 in a radially axially symmetric shape and penetrating to the outer surface, 18 and a pair ofpins 30, 30 that are loosely fitted and accommodated in thefemale screw 16 along themain axis C 1 of themain body 11, and whosedistal end 32 side is guided along a pair of guide holes 17, 18, bent, and inserted, respectively. Thepin 3 is screwed into thefemale screw 16 and its axial propulsive force Thepress screw 40 that presses the rear ends 31 and 31 of 0 and 30 is schematically configured.
本体11は、椎体L1、L2間の適正な間隔を保持するように形成された外形を有し、2つの椎体L1、L2の対向面L1a、L2a間がほぼ平行面あるいは背部側方向に減縮する例えば水平面に対して9°前後の傾斜面形状となっている場合に対応するように図1に示すような略中空円筒で、中央部外径が僅かに例えば0.1mmオーダー太めの太鼓状に形成される。本体11は、椎体L1、L2の太さすなわち奥行きなどの大きさによるが、椎体L1、L2間に収容される例えば概ね外径が18~22mmで、全長が25mm~45mm程度である。この場合、本体11の前端面12は、凸曲面又は図示しない略円錐面状に形成され、脊柱の背後の神経部に触れないよう神経部の十分手前の椎体L1、L2間に配置されることが必要である。Themain body 11 has an outer shape formed so as to maintain an appropriate distance between the vertebral bodies L1 and L2, and the opposing surfaces L1a and L2a of the two vertebral bodies L1 and L2 are substantially parallel or dorsal. For example, a drum with a substantially hollow cylinder as shown in FIG. 1 whose outer diameter is slightly thicker, for example, on the order of 0.1 mm, so as to correspond to the case of an inclined surface shape of about 9 ° with respect to a horizontal plane. It is formed in a shape. Themain body 11 is accommodated between the vertebral bodies L1 and L2, for example, having an outer diameter of approximately 18 to 22 mm and a total length of approximately 25 to 45 mm, depending on the size of the vertebral bodies L1 and L2. In this case, thefront end surface 12 of themain body 11 is formed in a convex curved surface or a substantially conical surface not shown, and is disposed between the vertebral bodies L1 and L2 sufficiently in front of the nerve portion so as not to touch the nerve portion behind the spinal column. It is necessary.
本体11は、椎体L1、L2間の強大な例えば1000kgオーダーの圧縮力に耐える十分な強度及び生物学的適合性を有する材料あるいは不活性材料から形成される。これらの材料としては、例えば、医療等級のステンレス鋼(SUS)、チタン(Ti)、多孔性タンタル複合材料等の多孔性材料などがあり、特に強度及び軽量な点からはTiが好適である。Themain body 11 is formed of a material having sufficient strength and biological compatibility to withstand a strong compressive force between the vertebral bodies L1 and L2, for example, on the order of 1000 kg, or an inert material. Examples of these materials include porous materials such as medical grade stainless steel (SUS), titanium (Ti), and a porous tantalum composite material. Ti is particularly preferable from the viewpoint of strength and light weight.
本体11の外面には、椎体L1、L2の対向面L1a、L2a部に外面頭頂部が食い込み係合する外面係合部として雄ねじ14、15が形成される。雄ねじ14、15の谷径が椎体L1、L2の対向面L1a、L2a間距離にほぼ接触する程度が望ましく、雄ねじ14、15のねじ山高さは例えば概ね3~4mm弱程度である。雄ねじ14、15は、脊椎に加わる高荷重により本体11が椎体L1、L2間から押し出されないよう椎体L1、L2内に十分に係合することが望ましい。雄ねじ14、15のピッチは、椎体間固定装置10を椎体L1、L2間の所定の位置に保持するのに必要なねじ係合量に応じて、例えば概ね2~3mm程度である。雄ねじ14、15のねじ山高さ及びピッチは、必要に応じて上記より小さい値に形成することができることはいうまでもない。External threads 14 and 15 are formed on the outer surface of themain body 11 as outer surface engaging portions in which the outer surface crown portion bites into and engages the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2. It is desirable that the valley diameter of themale screws 14 and 15 is substantially in contact with the distance between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2. The thread height of themale screws 14 and 15 is, for example, about 3 to 4 mm. Themale screws 14 and 15 are desirably sufficiently engaged in the vertebral bodies L1 and L2 so that themain body 11 is not pushed out between the vertebral bodies L1 and L2 due to a high load applied to the spine. The pitch of themale screws 14 and 15 is, for example, about 2 to 3 mm, depending on the amount of screw engagement required to hold theinterbody fusion device 10 at a predetermined position between the vertebral bodies L1 and L2. Needless to say, the thread height and pitch of themale threads 14, 15 can be formed to a value smaller than the above as required.
この実施例では、図3、4、6、7に示すように、本体11は前端面12側を残して後方の外面の左右両側の頭頂部が適宜な幅でカットされた略平行なカット側面19、19が形成されている。従って、前端面12側の雄ねじ15は全周完全ねじであるが、その後方のカット側面19、19が形成された断面部分円筒の上下外面に形成された雄ねじ14は部分ねじとなっている。雄ねじ14、15の軸方向先端(ねじ端)及び径方向外面頭頂部は尖鋭刃状に形成されており、前端面12側の完全ねじである雄ねじ15は、先頭ねじとして本体11を椎体L1、L2間に容易に螺入させることができる。In this embodiment, as shown in FIGS. 3, 4, 6, and 7, themain body 11 is a substantially parallel cut side surface in which the tops on both the left and right sides of the rear outer surface are cut with an appropriate width, leaving the front end face 12 side. 19 and 19 are formed. Therefore, themale screw 15 on the front end face 12 side is a full screw, but themale screw 14 formed on the upper and lower outer surfaces of the cross-section partial cylinder in which the cut side faces 19 and 19 on the rear side are formed is a partial screw. The axial front ends (screw ends) and the radial outer surface crests of themale screws 14 and 15 are formed in a sharp blade shape, and themale screw 15 which is a complete screw on thefront end surface 12 side uses themain body 11 as a vertebral body L1. , L2 can be easily screwed in.
本体11の全長に亘りカット側面19、19を形成した場合は、本体11を図示90°横にすれば本体11をねじ込まなくても椎体L1、L2の対向面L1a、L2a間に容易に挿入することもできる。この場合は、本体11を椎体L1、L2間に挿入後90°回転して縦てることにより、図8に示すように、本体11が椎体L1、L2間の適正な間隔を保持して固定される。また、カット側面19、19は、椎体L1、L2の対向面L1a、L2a間で骨の内部成長による骨状固定のための領域を提供するのに好適となる。When the cut side surfaces 19 and 19 are formed over the entire length of themain body 11, themain body 11 can be easily inserted between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2 without screwing themain body 11 if themain body 11 is turned 90 ° in the figure. You can also In this case, themain body 11 is rotated 90 ° after being inserted between the vertebral bodies L1 and L2, and is held vertically so that themain body 11 maintains an appropriate distance between the vertebral bodies L1 and L2, as shown in FIG. Fixed. The cut side surfaces 19 and 19 are suitable for providing a region for bone-like fixation by bone ingrowth between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
また、本体11のカット側面19、19の後端部は、椎体間固定装置10の椎体L1、L2間への挿入固定に際し、いずれも図示しない移植ドライバーのシャフトの先端に設けられたトング(挟持具)により把持されるようにもなっている。なお、上記移植ドライバーは公知のものを利用することができるが、本体11を椎体L1、L2間に嵌入させる本発明の一実施形態の本体嵌入ドライバーについては後述する。Further, the rear end portions of the cut side surfaces 19 and 19 of themain body 11 are provided at the tip of the shaft of the transplant driver (not shown) when theinterbody fusion device 10 is inserted and fixed between the vertebral bodies L1 and L2. It can also be held by a (holding tool). Although a known one can be used as the transplant driver, a main body insertion driver according to an embodiment of the present invention in which themain body 11 is inserted between the vertebral bodies L1 and L2 will be described later.
本体11の後端面13側から穿設された中空内面16aには、適宜奥行きの雌ねじ16が形成されるとともに、雌ねじ16の奥行き部の中空内面16aから椎体L1、L2方向に略軸対称に末広がりに主軸C1に対し傾斜角Θ1、Θ2の傾斜軸C2、C3に沿って外面まで貫通する上下1対のガイド孔17、18が穿設されている。傾斜角Θ1、Θ2は、椎体L1、L2の配置状況及びピン30の太さや可撓性等の状況に応じて適宜決定され、両者は略等しい又は若干異なる傾斜角に設定してもよい。同一条件では、ピン30の押し込み力は傾斜角Θ1、Θ2にほぼ比例するような傾向を示す。A hollowinner surface 16a drilled from therear end surface 13 side of themain body 11 is formed with afemale screw 16 having an appropriate depth, and is substantially axisymmetric in the vertebral body L1 and L2 directions from the hollowinner surface 16a of the depth portion of thefemale screw 16. A pair of upper and lower guide holes 17 and 18 penetrating to the outer surface along the inclined axes C2 and C3 of the inclination angles Θ1 and Θ2 with respect to the main axis C1 are formed at the end. The inclination angles Θ1 and Θ2 are appropriately determined according to the arrangement state of the vertebral bodies L1 and L2 and the situation such as the thickness and flexibility of thepin 30, and both may be set to be substantially equal or slightly different inclination angles. Under the same conditions, the pushing force of thepin 30 tends to be substantially proportional to the inclination angles Θ1 and Θ2.
なお、いずれも図示しないが、傾斜軸C2、C3は、ピン30の先端32が押し込まれて椎体L1、L2の外面からはみ出さない限り、主軸C1に対しそれぞれ任意の方向に且つ非対称に配置されてもよく、あるいは主軸C1に対し偏心し且つ任意の方向の面内に配置されてもよい。Although not shown, the inclined axes C2 and C3 are arranged in any direction and asymmetrically with respect to the main axis C1 as long as thedistal end 32 of thepin 30 is not pushed and protrudes from the outer surface of the vertebral bodies L1 and L2. Alternatively, it may be eccentric with respect to the main axis C1 and arranged in a plane in any direction.
また、本体11には、図2~4、6、7等に示すように、側面開口21、22、23及び上下面開口24、25、26などの複数の開口が穿設されている。そして、図2~4等に示すように、中空内面16aの先端面に側面開口21及び上下面開口24とも連通する小穴28が穿設されている。側面開口21、22、23は椎体L1、L2を囲繞する高度に血管化された組織に接触して血管新生を促進し、上下面開口24、25、26は椎体L1、L2の対向面L1a、L2a間で骨の内部成長による骨状固定を促進する。このため、本体11には強度を損なわない限り多数の開口を極力相互に連通するように穿設することが望ましい。Further, as shown in FIGS. 2 to 4, 6, 7, etc., themain body 11 has a plurality of openings such asside openings 21, 22, 23 and upper andlower openings 24, 25, 26. As shown in FIGS. 2 to 4 and the like, asmall hole 28 communicating with the side surface opening 21 and the upper andlower surface openings 24 is formed in the distal end surface of the hollowinner surface 16a. Theside openings 21, 22, 23 contact the highly vascularized tissue surrounding the vertebral bodies L1, L2 to promote angiogenesis, and the upper andlower surface openings 24, 25, 26 are opposite surfaces of the vertebral bodies L1, L2. Bone-like fixation by bone ingrowth is promoted between L1a and L2a. For this reason, it is desirable to drill a large number of openings in themain body 11 so as to communicate with each other as much as possible unless the strength is impaired.
さらに、本体11の後端面13には、1対の後端開口27、27及び円周部に沿って複数例えば6個の部分円弧状開口が穿設されている。この部分円弧状開口は、本体11を椎体L1、L2間に嵌入するための後述の本体嵌入ドライバーの先端係合部が嵌合して係合する後端係合部29である。後端係合部29は、このような部分円弧状開口に代えて、後端面13面に例えばいずれも図示しない六角形の凹溝を設けて本体嵌入ドライバーの六角形状の先端係合部を係合させるようにしてもよい。Furthermore, therear end surface 13 of themain body 11 has a pair ofrear end openings 27 and 27 and a plurality of, for example, six partial arc-shaped openings formed along the circumferential portion. This partial arc-shaped opening is a rearend engaging portion 29 in which a front end engaging portion of a main body insertion driver described later for fitting themain body 11 between the vertebral bodies L1 and L2 is engaged and engaged. The rearend engaging portion 29 is provided with, for example, a hexagonal concave groove (not shown) on therear end surface 13 in place of such a partial arc-shaped opening to engage the hexagonal front end engaging portion of the main body insertion driver. You may make it match.
なお、本体11に多孔性タンタル-カーボン複合材料例えば米国インプレックス社の商品名「ヘドロセル(HEDROCEL)」などの多孔性材料を用いる場合は、上記のような側面開口21、22、23及び上下面開口24、25、26を設けなくてもよく、相互に連結された多孔部が骨の内部成長及び血管新生を促進することができる。この多孔性材料は、多孔質の骨の構造に似ているとともに、人体の骨の弾性率に近い弾性率を有していることから、本発明の椎体間固定装置には最適とも言える。When themain body 11 is made of a porous tantalum-carbon composite material, for example, a porous material such as “HEDROCEL” (trade name of US Implex Co., Ltd.), theside openings 21, 22, 23 and the upper and lower surfaces as described above are used. Theopenings 24, 25, and 26 may not be provided, and the interconnected porous portions may promote bone ingrowth and angiogenesis. This porous material resembles the structure of a porous bone and has an elastic modulus close to that of a human bone, so it can be said to be optimal for the interbody fusion device of the present invention.
1対のピン30、30は、雌ねじ16内に上下に主軸C1方向に並列して遊嵌収容され、それぞれ後端31側が本体11の主軸C1に沿って延伸するとともに先端32側がそれぞれ1対のガイド孔17、18に沿って案内され屈曲し挿通される。各先端32は、適宜尖鋭状に形成され、本体11が椎体L1、L2間に差込まれる前の初期状態においては雄ねじ14の谷径以内に、すなわち谷径から突出しないようガイド孔17、18の出口内に収容されている。The pair ofpins 30, 30 are loosely accommodated in thefemale screw 16 in parallel in the direction of the main axis C <b> 1, therear end 31 side extends along the main axis C <b> 1 of themain body 11, and thefront end 32 side is a pair each. It is guided along the guide holes 17 and 18, bent and inserted. Eachtip 32 is appropriately sharpened, and in the initial state before themain body 11 is inserted between the vertebral bodies L1 and L2, the guide holes 17 and so on do not protrude from the valley diameter of themale screw 14, that is, from the valley diameter. It is accommodated in 18 outlets.
この実施例のピン30は、丸あるいは多角形など任意断面形状の中実又は中空の棒状体からなり、図3~4等に示すように、例えば一辺が数mm程度の四角棒材で、Ti製の本体より柔らかく、適宜な屈曲性及び強度のある例えば医療等級のSUSなどからなる。Thepin 30 of this embodiment is formed of a solid or hollow rod-like body having an arbitrary cross-sectional shape such as a circle or a polygon. For example, as shown in FIGS. It is softer than the main body and is made of, for example, medical grade SUS having appropriate flexibility and strength.
また、この実施例の中実又は中空の一体型棒状体からなるピン30に替えて、図4(a)又は(b)におけると同様な方向のピンの一部断面図である図5(a)~(f)に示すように、少なくとも先端側又は全長に亘り複数の薄板材30An、30Dn又は丸や各種扁平断面等任意断面型を有する線材30Bn、30En、30Cn、30Fnが積層されて一体的な丸あるいは多角形など任意断面形状の棒状積層体からなるそれぞれ別の変形形態のピン30A、30B、30C、30D、30E、30Fとすることもできる。Moreover, it replaces with thepin 30 which consists of a solid or hollow integrated rod-shaped body of this Example, and is a partial sectional view of the pin in the same direction as in FIG. 4A or FIG. ) To (f), a plurality of thin plate materials 30An, 30Dn or wire rods 30Bn, 30En, 30Cn, 30Fn having an arbitrary cross-sectional shape such as a round shape or various flat cross-sections are laminated and integrated at least over the tip side or the entire length. Thepins 30A, 30B, 30C, 30D, 30E, and 30F may be different from each other in the form of a rod-like laminate having an arbitrary cross-sectional shape such as a round shape or a polygonal shape.
変形形態のピン30A、30B、30Cは、それぞれ図5(a)、(b)、(c)に示すように、少なくとも先端側又は全長に亘り複数の薄板材30An、丸型線材30Bn、長円扁平型線材30Cnが積層されて一体的な略四角形断面形状の棒状積層体に形成される。As shown in FIGS. 5A, 5B, and 5C, thedeformed pins 30A, 30B, and 30C each include a plurality of thin plate materials 30An, a round wire 30Bn, and an oval shape at least on the distal end side or the entire length. The flat wire rods 30Cn are laminated to form a rod-like laminate having an integral substantially square cross section.
変形形態のピン30D、30E、30Fは、それぞれ図5(d)、(e)、(f)に示すように、少なくとも先端側又は全長に亘り幅の異なる複数の薄板材30Dn、丸型線材30En、長円扁平型線材30Fnが積層されて一体的な略菱形断面形状の棒状積層体に形成される。As shown in FIGS. 5D, 5E, and 5F, thedeformed pins 30D, 30E, and 30F include a plurality of thin plate materials 30Dn and round wire rods 30En having different widths at least on the tip side or the entire length, respectively. The oblong flat wire 30Fn is laminated to form a rod-like laminated body having a substantially rhombic cross section.
このような積層体からなる変形形態のピン30A、30B、30C、30D、30E、30Fは、形状を保持するために根元部の薄板材30An、30Dn又は線材30Bn、30En、30Cn、30Fnをそれぞれ相互に接着又は溶着して一体的に形成されることが望ましい。これにより、先端部側は各薄板材30An、30Dn又は線材30Bn、30En、30Cn、30Fnが各々フリーな状態であるため本体11のガイド孔17、18に沿って案内され比較的容易に屈曲し易くなり、本体のガイド孔に沿ってスムースに案内される操作性が向上する。さらに、これらの積層体からなるピン30A~30Fは、任意の形状に一体的に積層し形成することが容易であり、設計の自由度が向上する。The deformed pins 30A, 30B, 30C, 30D, 30E, and 30F made of such a laminate are mutually connected to the thin plate members 30An and 30Dn or the wire rods 30Bn, 30En, 30Cn, and 30Fn at the base portion in order to maintain the shape. It is desirable to be integrally formed by bonding or welding to each other. As a result, since the thin plate members 30An, 30Dn or the wire rods 30Bn, 30En, 30Cn, 30Fn are in a free state, the distal end side is guided along the guide holes 17 and 18 of themain body 11 and can be bent relatively easily. Thus, the operability of being smoothly guided along the guide hole of the main body is improved. Further, thepins 30A to 30F made of these laminates can be easily laminated and formed in an arbitrary shape, and the degree of design freedom is improved.
そこで、雌ねじ16及び中空内面16aの内径は、ピン30あるいは30A~30Fの太さ及び本体11の外径ならびにこの両者の強度等の兼ね合いから適宜決定される。中空内面16aは、雌ねじ16の下孔の役割をも有している。Therefore, the inner diameters of thefemale screw 16 and the hollowinner surface 16a are appropriately determined from the balance of the thickness of thepin 30 or 30A to 30F, the outer diameter of themain body 11, the strength of both, and the like. The hollowinner surface 16a also serves as a pilot hole for thefemale screw 16.
押圧ねじ40は、図8、9に示すように、本体11の雌ねじ16に螺合する雄ねじ部41の後端に本体11の後端面13の全面又は一部を覆う大きさの略円板フランジ状のキャップ42が連設されている。雄ねじ部41のキャップ42連設面からの長さは、ピン30を椎体L1、L2内に差込む長さに対応したピン30押し込みストロークに対応し、押圧ねじ40を雌ねじ16に前記ストローク螺入させたときキャップ42連設面が本体11の後端面13面に当接した状態となるように設定することが望ましい。また、キャップ42の大きさは、必要に応じて椎体L1、L2間を覆うような大きさとすることもできる。押圧ねじ40の材質としては、本体11と同様に、医療等級のSUS、Ti、多孔性タンタル複合材料等の多孔性材料などがあり、特に強度及び軽量な点からはTiが、骨の内部成長及び血管新生の促進性からは多孔性タンタル複合材料などが好適である。As shown in FIGS. 8 and 9, thepressing screw 40 is a substantially disc flange having a size that covers the whole or part of therear end surface 13 of themain body 11 at the rear end of themale screw portion 41 that is screwed into thefemale screw 16 of themain body 11. Acap 42 is continuously provided. The length of themale screw portion 41 from the surface where thecap 42 is provided corresponds to thepin 30 pressing stroke corresponding to the length of inserting thepin 30 into the vertebral bodies L1 and L2, and thepressing screw 40 is connected to thefemale screw 16 with the stroke screw. It is desirable to set so that the continuous surface of thecap 42 is in contact with therear end surface 13 of themain body 11 when it is inserted. Further, the size of thecap 42 can be set so as to cover between the vertebral bodies L1 and L2 as necessary. As the material of thepressing screw 40, there are porous materials such as medical grade SUS, Ti, porous tantalum composite material, etc., as in the case of themain body 11. Especially, Ti is a bone ingrowth in terms of strength and light weight. From the viewpoint of promoting angiogenesis, a porous tantalum composite material or the like is preferable.
キャップ42の後端面には、前記移植ドライバー又は後述の押圧ねじドライバーの先端係合部が係合する後端係合部として例えば、図10に示すように、十字溝44が形成されている。後端係合部44は、十字溝に代えていずれも図示しない移植ドライバー又は押圧ねじドライバーの例えば六角レンチ状に形成された先端係合部が係合する六角形穴を穿設してもよい。For example, as shown in FIG. 10, across groove 44 is formed on the rear end surface of thecap 42 as a rear end engaging portion that engages with a tip engaging portion of the transplant driver or a press screw driver described later. The rearend engaging portion 44 may be formed with a hexagonal hole that engages with a distal end engaging portion formed in, for example, a hexagon wrench shape of a transplant driver or a pressure screw driver (not shown) instead of the cross groove. .
図27は本発明の一実施形態の椎体間固定外科手術用椎体間スペース保持装置70の概念を示す縦断面図(上半部断面)、図28は図27の椎体間スペース保持装置70の平面図(上半部断面)、図29は図27のU-U矢視図である。FIG. 27 is a longitudinal sectional view (upper half section) showing a concept of an interbodyspace holding device 70 for interbody fusion surgery according to an embodiment of the present invention, and FIG. 28 is an interbody space holding device of FIG. 70 is a plan view (upper half section), and FIG. 29 is a view taken in the direction of arrows U-U in FIG.
本発明の一実施形態の椎体間スペース保持装置70は、後端に把持部72が設けられ、生体腹部MN1側に設けられた内視鏡用腹腔部Ma内のカニューレK(図1参照)を介して椎体L1、L2の前面近傍まで挿入される中空長尺の第1のシャフト部71、及び第1のシャフト部71の先端部71aに軸方向に沿って延設され、隣接する椎体L1、L2の左右両側面をそれぞれ挟持し固定する固定爪74bが先端に連接されて椎体L1、L2の直交面内で開閉可能な少なくとも各1対のクランプアーム74、74を有する保持装置本体70aと、第1のシャフト部71に前進/後退自在に外嵌され、後端に把持部77が設けられた中空長尺の第2のシャフト部76からなり、前進又は後退することにより各1対のクランプアーム74、74を縮径方向に閉じ又は拡径方向に開くクランプアーム開閉管70bと、からなる。保持装置本体70aとクランプアーム開閉管70bとから椎体クランプ機構を構成している。An intervertebral bodyspace holding device 70 according to an embodiment of the present invention includes a cannula K in an abdominal part Ma for endoscope provided on a living body abdominal part MN1 side with agrip 72 at a rear end (see FIG. 1). The hollow longfirst shaft portion 71 inserted to the vicinity of the front surface of the vertebral bodies L1 and L2 via the vertebral body and thedistal end portion 71a of thefirst shaft portion 71 are extended along the axial direction and are adjacent to the vertebrae. A holding device having at least one pair ofclamp arms 74 and 74 that can be opened and closed in the orthogonal planes of the vertebral bodies L1 and L2 with fixingclaws 74b that clamp and fix the left and right side surfaces of the bodies L1 and L2 respectively. It consists of amain body 70a and a hollow longsecond shaft portion 76 which is fitted to thefirst shaft portion 71 so as to be movable forward / backward and provided with a grippingportion 77 at the rear end. A pair ofclamp arms 74, 74 A clamparm closing pipe 70b open to closed or expanded direction direction of reducing the diameter, made of. A vertebral body clamping mechanism is constituted by the holding devicemain body 70a and the clamp arm opening /closing tube 70b.
この実施形態の保持装置本体70aは、図28に示すように、先端に各固定爪74bが連設され、後端部が第1のシャフト部71の先端部71aに連設され、フリー状態では固定爪74bをそれぞれ椎体L1、L2の直交面内で拡径して開くように屈曲されて弾支する弾性支持部74aを有する各1対のクランプアーム74、74を備える。As shown in FIG. 28, the holding devicemain body 70a of this embodiment has the fixedclaws 74b connected to the tip, the rear end connected to thetip 71a of thefirst shaft portion 71, and in the free state. A pair ofclamp arms 74 and 74 each having anelastic support portion 74a that is bent and elastically supported so as to expand and open the fixingclaws 74b in the orthogonal planes of the vertebral bodies L1 and L2, respectively.
そして、クランプアーム開閉管70bは、第2のシャフト部76の先端部76aが前進して弾性支持部74aを外側から押圧することにより各1対のクランプアーム74、74を2点鎖線で示す縮径方向に閉じ、その先端部76aが弾性支持部74aから後退することにより各1対のクランプアーム74、74を2点鎖線で示す拡径方向に開く。各1対のクランプアーム74、74は、第2のシャフト部76の先端部76aのC1軸方向の位置がX1(全閉位置)のとき最小に閉じ、X2(椎体把持/固定位置)のとき椎体L1、L2の左右側面を把持/固定し、X3(全開位置)のとき最大に開く。The clamp arm opening /closing pipe 70b is a contraction of the pair ofclamp arms 74, 74 indicated by a two-dot chain line by thedistal end portion 76a of thesecond shaft portion 76 moving forward and pressing theelastic support portion 74a from the outside. The pair ofclamp arms 74 and 74 are opened in a diameter increasing direction indicated by a two-dot chain line by closing in the radial direction and retreating thedistal end portion 76a from theelastic support portion 74a. Each of the pair ofclamp arms 74, 74 is closed to the minimum when the position of thedistal end portion 76a of thesecond shaft portion 76 in the C1 axis direction is X1 (fully closed position), and is X2 (vertebral body grasping / fixing position). Sometimes the left and right lateral surfaces of the vertebral bodies L1 and L2 are gripped / fixed, and open to the maximum at X3 (fully open position).
固定爪74bの椎体挟持面には、椎体L1、L2の左右側面に突刺可能な複数の尖鋭突起74cを有する。The vertebral body clamping surface of the fixedclaw 74b has a plurality ofsharp protrusions 74c that can be pierced on the left and right side surfaces of the vertebral bodies L1 and L2.
また、この実施例の保持装置本体70aは、第1のシャフト部71の先端部71aに椎体L1、L2の外径より僅かに狭い間隔で椎体間スペースMに向かい軸方向に沿って対向状態で延設され、先端部から椎間板スペースM内に挿入されることにより隣接する椎体L1、L2を適正な間隔に修正して保持するような外形形状に形成された少なくとも1対のスペーサー73、73をさらに備える。1対のスペーサー73、73と各1対のクランプアーム74、74とはその主軸が略90°ずれた各平面内に設けられる。Further, the holdingdevice body 70a of this embodiment is opposed to the intervertebral space M along the axial direction at a slightly narrower distance than the outer diameter of the vertebral bodies L1 and L2 to thedistal end portion 71a of thefirst shaft portion 71. At least one pair ofspacers 73 formed in an outer shape that extends in a state and is inserted into the intervertebral disc space M from the distal end portion so that the adjacent vertebral bodies L1 and L2 are corrected and held at appropriate intervals. , 73 are further provided. The pair ofspacers 73 and 73 and the pair ofclamp arms 74 and 74 are provided in respective planes whose main axes are shifted by approximately 90 °.
こような、保持装置本体70aの構成により、構造及び操作が簡易化され、1対のスペーサー73、73が先端から椎間板スペースM内に挿入されることにより隣接する椎体L1、L2を適正な間隔に修正して保持するとともに、各1対のクランプアーム74、74の複数の尖鋭突起74cを有する固定爪74bにより隣接する椎体L1、L2の左右両側面をそれぞれ挟持し固定することから、椎体間固定外科手術における隣接する椎体L1、L2の適正な間隔修正及び信頼性の高い固定/保持が同時に短時間で行うことができる。これにより、従来の椎体間固定外科手術に比べて手術時間が短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担をさらに軽減することができる。Such a configuration of the holding devicemain body 70a simplifies the structure and operation, and the pair ofspacers 73 and 73 are inserted into the intervertebral disc space M from the distal end, so that the adjacent vertebral bodies L1 and L2 are properly connected. Since the distance between the left and right side surfaces of the adjacent vertebral bodies L1 and L2 is held and fixed by the fixingclaws 74b having a plurality ofsharp protrusions 74c of each pair ofclamp arms 74 and 74, respectively, while being corrected and held at intervals. In the interbody fusion surgery, it is possible to correct the distance between adjacent vertebral bodies L1 and L2 and to perform reliable fixation / retention simultaneously in a short time. As a result, the operation time can be shortened compared to the conventional interbody fusion surgery, so that the physical and mental burdens of medical staff including patients and doctors, the surgical invasion of patients, and the economic burden can be further reduced. it can.
図30は本発明の変形実施形態の椎体間固定外科手術用椎体間スペース保持装置70´の概念を示す平面図(上半部断面)、図31は図30の椎体間スペース保持装置70´の縦断面図(上半部断面)、図32は図31のV-V矢視図である。この形態における前記一実施形態と同様な機能を有する構成部材には、若干寸法形状が異なっても記述を平易化するため同一の符号及び記号を付してある。30 is a plan view (upper half section) showing a concept of an intervertebral bodyspace holding device 70 ′ for interbody fusion surgery according to a modified embodiment of the present invention, and FIG. 31 is an interbody space holding device of FIG. 70 'is a longitudinal sectional view (upper half section), and FIG. 32 is a view taken along arrow VV of FIG. In this embodiment, components having the same functions as those of the above-described embodiment are given the same reference numerals and symbols in order to simplify the description even if the dimensions and shapes are slightly different.
この変形実施形態の椎体間スペース保持装置70´は、前記一実施形態と同様な第1のシャフト部71、及び第1のシャフト部71の先端部71aに第1の支持軸P1を介して椎体L1、L2の直交面内で揺動自在に重ね合されて枢着され、前記一実施形態と同様な固定爪74bが支持部74´aの先端に連接された各1対のクランプアーム74´、74´を有する保持装置本体70´aと、前記一実施形態と同様な第2のシャフト部76及び各1対のクランプアーム74´、74´の中間部の反重ね合せ面側に第2の支持軸P2、P2を介してそれぞれ一端部が揺動自在に重ねられて枢着されるとともに、その各他端部が第2のシャフト部76の先端部76aに突設されたブラケット78に第3の支持軸P3回りに揺動自在に重ね合されて枢着された各1対のリンク部材79、79を有するクランプアーム開閉管70´bと、からなる。The interbodyspace holding device 70 ′ of this modified embodiment is similar to thefirst shaft portion 71 and thedistal end portion 71 a of thefirst shaft portion 71 similar to that of the above-described one embodiment via the first support shaft P <b> 1. A pair of clamp arms each having a fixedclaw 74b that is pivotably overlapped and pivotally mounted in an orthogonal plane of the vertebral bodies L1 and L2, and is connected to the tip of the support portion 74'a. The holding device main body 70'a having 74 'and 74' and thesecond shaft portion 76 and the intermediate portion of each pair of clamp arms 74 'and 74' on the side opposite to the overlapping surface as in the above embodiment Brackets in which one end portions are pivotably overlapped and pivotally mounted via the second support shafts P2 and P2, and the other end portions project from thetip end portion 76a of thesecond shaft portion 76. 78 is pivotally overlapped with the third support shaft P3 so as to be swingable. And the clamp arm open tube 70'b having alink member 79, 79 of each pair which is composed of.
保持装置本体70´a及びクランプアーム開閉管70´bは、椎体クランプ機構を構成している。この変形実施形態の椎体クランプ機構は、支持部74´aが前記一実施形態の適宜な弾力性を有する弾性支持部74aとは異なり剛性が大きい形状に形成されており、図30に示すように、第2のシャフト部76が前進又は後退することにより各1対のリンク部材79、79を第3の支持軸P3回りに反時計方向又は時計方向に揺動させて各1対のクランプアーム74´、74´を椎体L1、L2の直交面内で第1の支持軸P1を支点としていずれも2点鎖線で示す縮径方向に閉じ又は拡径方向に開くトグル機構を構成している。各1対のクランプアーム74´、74´は、第2のシャフト部76の先端部76aのC1軸方向の位置がX1´(全閉位置)のとき最小に閉じ、X2(椎体把持/固定位置)のとき椎体L1、L2の左右側面を把持/固定し、X3´(全開位置)のとき最大に開く。The holding device body 70'a and the clamp arm opening / closing tube 70'b constitute a vertebral body clamping mechanism. In the vertebral body clamping mechanism of this modified embodiment, the support portion 74'a is formed in a shape having high rigidity unlike theelastic support portion 74a having appropriate elasticity of the one embodiment, as shown in FIG. Further, as thesecond shaft portion 76 moves forward or backward, each pair oflink members 79, 79 are swung counterclockwise or clockwise around the third support shaft P3 to each pair of clamp arms. Thetoggle mechanism 74 ′, 74 ′ is closed in the reduced diameter direction indicated by the two-dot chain line or opened in the enlarged diameter direction with the first support axis P1 as a fulcrum within the orthogonal plane of the vertebral bodies L1, L2. . Each pair ofclamp arms 74 ′ and 74 ′ is closed to the minimum when the position of thedistal end portion 76 a of thesecond shaft portion 76 in the C1 axis direction isX 1 ′ (fully closed position), and X 2 (vertebral body grasping / fixing) Position), the left and right lateral surfaces of the vertebral bodies L1 and L2 are gripped / fixed, and the X3 '(fully open position) opens to the maximum.
この変形実施形態の椎体間スペース保持装置70´は、保持装置本体70´a及びクランプアーム開閉管70´bからなる椎体クランプ機構がトグル機構を構成していることから、隣接する椎体L1、L2の左右両側面の挟持/固定力が強大化され、椎体間スペース保持装置の信頼性を一層向上させることができる。In the interbodyspace holding device 70 ′ of this modified embodiment, the vertebral body clamping mechanism including the holding devicemain body 70 ′ a and the clamp arm opening /closing tube 70 ′ b constitutes a toggle mechanism. The clamping / fixing force between the left and right side surfaces of L1 and L2 is increased, and the reliability of the interbody space holding device can be further improved.
また、この変形実施形態の椎体間スペース保持装置70´も、第1のシャフト部71の先端部71aに前記一実施形態の椎体間スペース保持装置70と同様の、隣接する椎体L1、L2を適正な間隔に修正して保持するような外形形状に形成された少なくとも1対のスペーサー73、73をさらに備える。Also, the interbodyspace holding device 70 ′ of this modified embodiment is similar to the adjacentvertebral body L 1, similar to the interbodyspace holding device 70 of the above embodiment, at thedistal end portion 71 a of thefirst shaft portion 71. It further includes at least one pair ofspacers 73 and 73 formed in an outer shape so that L2 is corrected and held at an appropriate interval.
また、上記一実施形態及び変形実施形態の椎体間スペース保持装置70、70´の第1及び第2のシャフト部71、76は、図29、32に示すように、いずれも例えば略長円形、略楕円形又は略四角形断面あるいは図示しない略円形や略多角形断面など椎体の外形形状/寸法に相応する中空形状に形成される。そして、例えば本体嵌入ドライバーのシャフト部81に比べて第1のシャフト部71が相当大きくなるような場合、第1のシャフト部71内には、挿通される椎体間固定装置10あるいは椎体間固定装置10の本体11を椎体L1、L2間に嵌入するための後述の本体嵌入ドライバーのシャフト部81の挿入案内用として、椎体間固定装置10あるいはシャフト部81の最大外径より例えば2mm程度大きな内径のガイド筒71b(2点鎖線で示す)を必要に応じて設けてもよい。In addition, as shown in FIGS. 29 and 32, the first andsecond shaft portions 71 and 76 of the interbodyspace holding devices 70 and 70 ′ of the one embodiment and the modified embodiment are both substantially oval, for example. And a hollow shape corresponding to the outer shape / size of the vertebral body, such as a substantially elliptical or substantially rectangular cross section, or a substantially circular or substantially polygonal cross section (not shown). For example, when thefirst shaft portion 71 is considerably larger than theshaft portion 81 of the main body insertion driver, the intervertebralbody fixing device 10 or the intervertebral body is inserted into thefirst shaft portion 71. For insertion guide of ashaft portion 81 of a body insertion driver to be described later for inserting themain body 11 of the fixingdevice 10 between the vertebral bodies L1 and L2, for example 2 mm from the maximum outer diameter of theinterbody fixing device 10 or theshaft portion 81. Aguide cylinder 71b (indicated by a two-dot chain line) having a relatively large inner diameter may be provided as necessary.
また、図27乃至29に示すように、第1のシャフト部71の先端部の左右のクランプアーム74、74部に対応する内面に架け亘る補強板75、75を必要に応じて設けてもよい。この場合、補強板75、75間の距離は、椎体間固定装置10あるいはシャフト部81に干渉しないようにそれらの最大外径より若干例えば少なくとも2mm程度大きく設定される。In addition, as shown in FIGS. 27 to 29, reinforcingplates 75 and 75 extending over the inner surfaces corresponding to the left and right clamparms 74 and 74 at the tip of thefirst shaft portion 71 may be provided as necessary. . In this case, the distance between the reinforcingplates 75 and 75 is set to be slightly larger than, for example, at least about 2 mm from their maximum outer diameter so as not to interfere with theinterbody fusion device 10 or theshaft portion 81.
図33は本発明のさらに別の変形実施形態の椎体間スペース保持装置70´´の概念を示す縦断面図(上半部断面)、図34は図33の椎体間スペース保持装置70´´の平面図(上半部断面)、図35は図34のW-W矢視図である。この形態における前記実施形態と同様な機能を有する構成部材には、若干寸法形状が異なっても記述を平易化するため同一の符号及び記号を付してある。FIG. 33 is a longitudinal sectional view (upper half section) showing the concept of an interbodyspace holding device 70 ″ of still another modified embodiment of the present invention, and FIG. 34 is an interbodyspace holding device 70 ′ of FIG. ′ ′ Plan view (upper half section), FIG. 35 is a view taken along the line WW in FIG. 34. In this embodiment, components having the same functions as those of the embodiment described above are given the same reference numerals and symbols in order to simplify the description even if the dimensions are slightly different.
この別の変形実施形態の椎体間スペース保持装置70´´は、後端に把持部72が設けられ、生体腹部MN1側に設けられた内視鏡用腹腔部Ma内のカニューレK(図1参照)を介して椎体L1、L2の前面近傍まで挿入される中空長尺の第1のシャフト部71´と、第1のシャフト部71´の外面に軸方向に沿って回転自在に延設され、先端に形成されたねじ部76´aが隣接する椎体L1、L2の一方又は両方の前面部に羅入し固定される長尺固定ねじ部材76´bと、第1のシャフト部71´の先端部71´aに突設され、隣接する椎体L1、L2の一方又は両方の前面部に突刺可能な一つ又は複数の針状突起71cと、を備える。The intervertebral bodyspace holding device 70 ″ according to another modified embodiment is provided with a graspingportion 72 at the rear end, and a cannula K (see FIG. 1) in the abdominal portion Ma for endoscope provided on the living body abdominal portion MN1 side. A hollow longfirst shaft portion 71 ′ inserted to the vicinity of the front surface of thevertebral bodies L 1 andL 2 via the reference), and extended on the outer surface of thefirst shaft portion 71 ′ so as to be rotatable along the axial direction. A long fixed screw member 76'b in which the screw portion 76'a formed at the tip is inserted into and fixed to one or both front surface portions of the adjacent vertebral bodies L1, L2, and thefirst shaft portion 71. And one or a plurality of needle-like protrusions 71c that can project into one or both front surface portions of the adjacent vertebral bodies L1 and L2.
長尺固定ねじ部材76´bは、第1のシャフト部71´の外面に立設された後部支持部材75a及び前部支持部材75bの挿通孔75c内に回転自在に挿通され、後端部に図示しないドライバー又はレンチ係合溝あるいは六角型外形を有する頭部76´cを備えている。The long fixing screw member 76'b is rotatably inserted into theinsertion hole 75c of therear support member 75a and thefront support member 75b provided upright on the outer surface of the first shaft portion 71 '. A driver or wrench engaging groove (not shown) or a head portion 76'c having a hexagonal outer shape is provided.
長尺固定ねじ部材76´b、後部支持部材75a及び前部支持部材75bは椎体固定機構76´を構成し、カニューレK内に挿入された第1のシャフト部71´を後端部又は把持部72を介して押圧して先端部の針状突起71cを隣接する椎体L1、L2の一方又は両方の前面部に突刺した後に、頭部76´cを介して長尺固定ねじ部材76´bを押圧しながら例えば時計回りに回転させて椎体L1、L2の一方又は両方の前面部に羅入し固定する。The long fixing screw member 76'b, therear support member 75a, and thefront support member 75b constitute a vertebral body fixing mechanism 76 ', and the first shaft portion 71' inserted into the cannula K is held at the rear end portion or gripped. After pressing through theportion 72 to pierce the frontal portion of one or both of the adjacent vertebral bodies L1 and L2 with the needle-like protrusion 71c at the distal end, the elongated fixingscrew member 76 ′ is inserted through thehead 76′c. While pressing b, it is rotated clockwise, for example, and inserted into and fixed to one or both front portions of the vertebral bodies L1, L2.
この変形実施形態の椎体間スペース保持装置70´´は、第1のシャフト部71´の外面及び先端部71´aにそれぞれ設けられた椎体固定機構76´及び針状突起71cにより、隣接する椎体L1、L2の一方又は両方の前面部にそれぞれ螺入、突刺して抜け止め効果を伴って固定することから、構造及び操作が簡易であるとともに、その後で椎体間固定装置10を椎体L1、L2間に移植固定する際に比較的大きな外力が負荷される椎体L1、L2が後方又は左右の側方にずれないため椎体間固定外科手術における椎体間スペース保持の信頼性が確保される。The interbodyspace holding device 70 ″ of this modified embodiment is adjacent to the vertebralbody fixing mechanism 76 ′ and the needle-like protrusion 71 c provided on the outer surface of thefirst shaft portion 71 ′ and thedistal end portion 71 ′, respectively. The vertebral bodies L1 and L2 are fixed to each other by screwing and piercing into the front portions of the vertebral bodies L1 and L2, respectively, so that the structure and operation are simple. Since the vertebral bodies L1 and L2 to which a relatively large external force is applied when transplanted and fixed between the vertebral bodies L1 and L2 are not displaced rearward or left and right, the reliability of intervertebral body space retention in interbody fusion surgery Sex is secured.
なお、前記把持部72、77は、それぞれカニューレKの外部に順次露出する長さに設定された第1、第2のシャフト部71、71´、76の後端に嵌着されたボス部72a、77a上に立設された少なくとも1対又は複数の取手(ハンドル)状に形成されているが、公知の円筒型などその他任意の把持形状(図示しない)に形成することができる。The grippingportions 72 and 77 areboss portions 72a fitted to the rear ends of the first andsecond shaft portions 71, 71 'and 76, which are set to lengths that are sequentially exposed to the outside of the cannula K, respectively. , 77a and at least one handle or a plurality of handles (handles) standing upright, but can be formed in any other gripping shape (not shown) such as a known cylindrical type.
また、第1、第2のシャフト部71、71´、76の先端部及びその他のクランプ機構、椎体固定機構76´及びスペーサー73、73´等の部材を除くシャフト部の後方部材は、例えば樹脂などの軽量な高分子材料から構成することができる。椎体間スペース保持装置70、70´、70´´は、極力軽量なTiや高分子材料を組み合せて構成するなど全体を軽量化して操作性を向上させることが望ましい。Further, the rear members of the shaft portion excluding the distal ends of the first andsecond shaft portions 71, 71 ′, 76 and other clamp mechanisms, the vertebralbody fixing mechanism 76 ′, thespacers 73, 73 ′, etc. It can be composed of a lightweight polymer material such as a resin. It is desirable that the interbodyspace holding devices 70, 70 ′, and 70 ″ are composed of a combination of Ti and polymer materials that are as light as possible to reduce the overall weight and improve operability.
図36は本発明の一実施形態の本体嵌入ドライバー80の概念を示す縦断面図(上半部断面)、図37は図36のS-S矢視図、図38は本発明の一実施形態の押圧ねじドライバー90の概念を示す側面図、図39は図38のT-T矢視図である。FIG. 36 is a longitudinal sectional view (upper half section) showing a concept of a mainbody insertion driver 80 according to an embodiment of the present invention, FIG. 37 is a view taken along the line SS of FIG. 36, and FIG. 38 is an embodiment of the present invention. FIG. 39 is a view taken along the line TT in FIG. 38.
一実施形態の本体嵌入ドライバー80は、後端に把持部82が設けられ、前記椎体間スペース保持装置70、70´、70´´の第1のシャフト部71、71´内を介して椎体L1、L2の前面近傍まで挿入される中空長尺のシャフト部81と、シャフト部81の先端に椎体間固定装置10の本体11の後端面13に形成された後端係合部29(図3)に係合する先端係合部83とからなる。In one embodiment, thebody insertion driver 80 is provided with a grippingportion 82 at the rear end, and the vertebrae are interposed through thefirst shaft portions 71 and 71 ′ of the interbodyspace holding devices 70, 70 ′ and 70 ″. A hollowlong shaft portion 81 inserted to the vicinity of the front surfaces of the bodies L1 and L2, and a rear end engaging portion 29 (formed on therear end surface 13 of thebody 11 of theinterbody fusion device 10 at the distal end of the shaft portion 81) 3) and atip engaging portion 83 that engages.
把持部82は、前記椎体間スペース保持装置70、70´、70´´の第1のシャフト部71、71´後端の外部に露出する長さに設定されたシャフト部81の後端に嵌着されたボス部82a上に立設された少なくとも1対又は複数の取手(ハンドル)状に形成されている。Thegripping part 82 is attached to the rear end of theshaft part 81 set to a length exposed to the outside of the rear end of thefirst shaft parts 71, 71 ′ of the interbodyspace holding devices 70, 70 ′, 70 ″. It is formed in the shape of at least one pair or a plurality of handles (handles) standing on the fittedboss portion 82a.
先端係合部83は、本体11の部分円弧状の後端係合部29(図3)に嵌入して係合する複数の部分円弧形の爪状に形成されており、その爪の先端部は角部がカットされるなど後端係合部29に嵌入し易い形状となっている。なお、先端係合部83は、後端係合部29の任意の形状に適合する形状に形成される。The frontend engaging portion 83 is formed in a plurality of partial arcuate claw shapes that are engaged with and engaged with the partial arc-shaped rear end engaging portion 29 (FIG. 3) of themain body 11, and the front end of the nail The portion has a shape that can be easily fitted into the rearend engaging portion 29, such as a corner portion being cut. The frontend engaging portion 83 is formed in a shape that matches the arbitrary shape of the rearend engaging portion 29.
先端係合部83はSUSやTiなどの硬質の金属製で、シャフト部81は例えば樹脂などの軽量な高分子材料から構成することができる。本体嵌入ドライバー80は、極力軽量なTiや高分子材料を組み合せて構成するなど全体を軽量化して操作性を向上させることが望ましい。Thetip engaging portion 83 is made of a hard metal such as SUS or Ti, and theshaft portion 81 can be made of a light polymer material such as a resin. It is desirable that the mainbody insertion driver 80 is lightened as a whole, for example, to be constructed by combining Ti and polymer materials that are as light as possible to improve operability.
押圧ねじドライバー90は、後端に把持部92が設けられ、本体嵌入ドライバー80のシャフト部81内を介して椎体L1、L2の前面近傍まで挿入される長尺のシャフト部91と、シャフト部91の先端に押圧ねじ40のキャップ42の後端部に形成された後端係合部44(図10)に係合する先端係合部93とからなる。Thepressing screw driver 90 is provided with agrip portion 92 at the rear end, and along shaft portion 91 inserted into the vicinity of the front surface of the vertebral bodies L1 and L2 through theshaft portion 81 of the mainbody insertion driver 80, and the shaft portion Thefront end 91 includes a frontend engaging portion 93 that engages with a rear end engaging portion 44 (FIG. 10) formed at the rear end portion of thecap 42 of thepressing screw 40.
把持部92は、本体嵌入ドライバー80後端の外部に露出する長さに設定されたシャフト部91の後端に嵌着されたボス部92a上に立設された少なくとも1対又は複数の取手(ハンドル)状に形成されている。すなわち、押圧ねじドライバー90は、図1に示すように、椎体間固定装置10の椎体L1、L2間への固定完了状態において本体嵌入ドライバー80の後端面より外側に露出して把持部92を把持できる十分な長さを有する。Thegrip portion 92 is at least one pair or a plurality of handles (e.g., standing on aboss portion 92a fitted to the rear end of theshaft portion 91 set to a length exposed to the outside of the rear end of the mainbody insertion driver 80. It is formed in a handle shape. That is, as shown in FIG. 1, thepressing screw driver 90 is exposed to the outside from the rear end surface of the mainbody insertion driver 80 when the intervertebralbody fixing device 10 is fixed between the vertebral bodies L1 and L2, and is held by thegrip portion 92. It has a sufficient length that can be gripped.
先端係合部93の先端部93aは、押圧ねじ40の後端係合部44(図10)に係合する例えばプラスドライバ状に形成されている。なお、後端係合部44が十字溝に代えて図示しない例えば六角形穴に形成される場合は、先端部93aはその六角形穴に係合する六角レンチ状に形状されるなど、後端係合部44の任意の形状に適合する形状(図示しない)に形成される。Thefront end portion 93a of the frontend engaging portion 93 is formed, for example, in the shape of a plus driver that engages with the rear end engaging portion 44 (FIG. 10) of thepressing screw 40. When the rearend engaging portion 44 is formed in a hexagonal hole (not shown) instead of the cross groove, thefront end 93a is shaped like a hexagon wrench that engages with the hexagonal hole. It is formed in a shape (not shown) that fits any shape of the engagingportion 44.
先端係合部93はSUSやTiなどの硬質の金属製で、シャフト部91は例えば樹脂などの軽量な高分子材料から構成することができる。押圧ねじドライバー90は、シャフト部91を中空状に形成するなども含めて全体を軽量化して操作性を向上させることが望ましい。Thetip engaging portion 93 is made of a hard metal such as SUS or Ti, and theshaft portion 91 can be made of a light polymer material such as a resin. It is desirable that thepressure screw driver 90 is lightened as a whole including theshaft portion 91 formed in a hollow shape to improve operability.
なお、前記把持部82、92は、公知の円筒型などその他任意の把持形状(図示しない)に形成することができる。The grippingportions 82 and 92 can be formed in any other gripping shape (not shown) such as a known cylindrical shape.
ここで、前記変形実施形態の椎体間スペース保持装置70´´を適用した変形実施形態の椎体間固定外科手術システムの概念縦断面図(主要部断面)を図40に示す。Here, FIG. 40 shows a conceptual longitudinal cross-sectional view (cross-section of the main part) of the interbody fusion surgery system of the modified embodiment to which the interbodyspace holding device 70 ″ of the modified embodiment is applied.
次に、図1、8、9、27~29、36~39、41~43等を参照し、一実施形態の椎体間固定装置10を、腹部MN1側から脊椎の前面まで形成された内視鏡用腹腔部Ma内のカニューレKを介していずれも図示しない内視鏡(又は腹腔鏡)あるいは前記カプセル内視鏡で観察しながら椎体間スペース保持装置70、本体嵌入ドライバー80及び押圧ねじドライバー90を用い、椎体L1、L2の間の椎間板M部に嵌入し椎体L1、L2間を固定する椎体間固定外科手術方法について、その主要な特徴となる部分を説明する。Next, referring to FIGS. 1, 8, 9, 27 to 29, 36 to 39, 41 to 43, etc., theinterbody fusion device 10 according to one embodiment is formed from the abdominal MN1 side to the front surface of the spine. While observing with an endoscope (or a laparoscope) (not shown) or the capsule endoscope through a cannula K in the abdominal cavity Ma for endoscope, the interbodyspace holding device 70, thebody insertion driver 80, and a pressing screw An intervertebral body fixing surgical method that uses ascrewdriver 90 to fit into the intervertebral disc M between the vertebral bodies L1 and L2 and fixes the vertebral bodies L1 and L2 will be described as a main feature.
手術の前に、患者の最適な椎体固定装置10の寸法及び望ましい伸延が評価決定された後、図41(a)に示すように、患者を伸延及び椎体(椎骨)の整列修正が同時にできる脊柱手術台Bd上に上向きに寝かせて脚をく字状に屈曲させるいわゆる砕石位をとった状態で専用の足代に載せ、肩が頭側に下がらないように腕及び脚部を含む人体MNを固定する。Prior to surgery, after the patient's optimal vertebralbody fixation device 10 dimensions and desired distraction have been evaluated, the patient is distracted and the vertebral body (vertebral) alignment corrected simultaneously as shown in FIG. 41 (a). Human body MN including arms and legs so that the shoulder is not lowered to the head side in a so-called crushed position where the legs are bent upwardly on the spinal table Bd To fix.
引続き、図41(b)に示すように、脊柱手術台Bdを傾け、足部を上げて頭部を下げる状態いわゆる頭部低位・腰部高位のトレンデレンブルグ状態にし、以下の手術を開始する。Subsequently, as shown in FIG. 41 (b), the spinal table Bd is tilted, the foot is raised and the head is lowered, so that the head is lowered and the waist is in the Trendelenburg state, and the following operation is started.
このトレンデレンブルグ状態で、図42に示すように、腹部MN1の所定の位置に例えば電気メスにより数mm程度の切開創Mfを適宜複数ヶ所設けて腹腔鏡用ポートMa、Mb、Mc、Md、Me等を設定し、そこから対象となる前記椎体L1、L2に対応する手術場所を観察するために例えばアクセスニードルなどの穿刺針を通して腹腔内にCO2などの不活性ガスである気腹ガスを注入する。このように、腹部MN1側から気腹ガスを腹腔内に注入して腸部を下腹部側に押し遣り、内視鏡(又は腹腔鏡)を介して椎体L1、L2近傍の視界を確保する。ポートMaは、前記椎体間固定装置10を挿入するための主要な腹腔鏡用ポートなるもので、前記椎体L1、L2間のほぼ中央部を目指して配置される。ポートMbは、腹部MN1の中心軸上で例えば臍から数mm~10cm程度頭部寄りに配置される。腹壁は、椎体L1、L2部とは反対の上腹部の脈管の側方に配置される。In this Trendelenburg state, as shown in FIG. 42, laparoscopic ports Ma, Mb, Mc, Md, and a plurality of incision wounds Mf of about several millimeters are provided at predetermined positions of the abdominal part MN1, for example, with an electric knife. In order to observe the surgical site corresponding to the target vertebral bodies L1 and L2 from there, for example, Me or the like, an insufflation gas such as CO2 is supplied into the abdominal cavity through a puncture needle such as an access needle. inject. In this way, pneumoperitoneum gas is injected into the abdominal cavity from the abdominal part MN1 side, the intestine part is pushed to the lower abdominal part side, and a field of view near the vertebral bodies L1 and L2 is secured through the endoscope (or laparoscope). . The port Ma is a main laparoscopic port for inserting theinterbody fusion device 10 and is arranged so as to aim at a substantially central portion between the vertebral bodies L1 and L2. The port Mb is disposed on the central axis of the abdominal part MN1, for example, a few millimeters to 10 cm from the navel near the head. The abdominal wall is disposed on the side of the upper abdominal vessel opposite to the vertebral bodies L1 and L2.
ポートMc、Mdは、ポートMbの左右側に互いに対向するように僅かにずらして配置される。ポートMc、Mdを通して図示しない適宜なリトラクタ(鉗子)を挿入し、対象となる椎体部の周囲から適宜内臓物を引き離す処置などが行われる。The ports Mc and Md are arranged slightly shifted so as to face each other on the left and right sides of the port Mb. An appropriate retractor (forceps) (not shown) is inserted through the ports Mc and Md, and a treatment for appropriately separating the internal organs from the periphery of the target vertebral body is performed.
このようにして、腹部MN1側に設けられた複数個所のポートMa、Mb、Mc、Md、Meから内視鏡(又は腹腔鏡)を介して椎体L1、L2に隣接する腹部側及び左右側面のいずれも図示しない硬膜包及び横断神経根などの骨辺縁物を脇に押し遣るなどの事前処置を施す(事前処置工程)。In this way, the abdominal side and the left and right side surfaces adjacent to the vertebral bodies L1 and L2 from the ports Ma, Mb, Mc, Md, and Me provided on the abdominal part MN1 side via the endoscope (or laparoscope) In either case, a pretreatment such as pushing a bone margin such as a dural capsule and a transverse nerve root (not shown) to the side is performed (pretreatment step).
この際、図43に示すように、例えばバーサステップあるいはバーサポートなどの処置用トロカールスリーブTrがポートMa部内に配置される。トロカールスリーブTrの外筒である中空状のカニューレ(又はパワーシールドスリーブ)K内には、穿刺針や穿刺針が抜き外された後に後述の各種処置具Tpが脊柱(脊椎)L部まで挿入される。At this time, as shown in FIG. 43, for example, a treatment trocar sleeve Tr such as a verse step or a bar support is disposed in the port Ma portion. In the hollow cannula (or power shield sleeve) K which is the outer cylinder of the trocar sleeve Tr, after the puncture needle and the puncture needle are removed, various treatment tools Tp described later are inserted up to the spinal column (spine) L portion. The
次いで、腹部MN1側に設けられた内視鏡用ポートMa部内に挿入されたカニューレKを介して、図27、28に示すように、椎体L1、L2の前面近傍まで各1対のクランプアーム74、74を閉じた状態の椎体間スペース保持装置70を挿入し、1対のスペーサー73、73を先端から椎間板スペースM内に挿入して隣接する椎体L1、L2を適正な間隔に修正して保持すると同時に、各1対のクランプアーム74、74を開き固定爪74bにより隣接する椎体L1、L2の左右両側面をそれぞれ挟持するように再度閉じて複数の尖鋭突起74cを介して(突刺し)固定する(椎体間スペース保持工程)。このとき、各1対のクランプアーム74、74の開閉操作は、前記したように、クランプアーム開閉管70bを後退又は前進させることにより行う。Next, as shown in FIGS. 27 and 28, a pair of clamp arms to the vicinity of the front surfaces of the vertebral bodies L1 and L2 through a cannula K inserted into the endoscope port Ma provided on the abdominal part MN1 side. The intervertebralspace holding device 70 with 74 and 74 closed is inserted, and a pair ofspacers 73 and 73 are inserted into the intervertebral disc space M from the tip to correct the adjacent vertebral bodies L1 and L2 to an appropriate interval. At the same time, the pair ofclamp arms 74 and 74 are opened and closed again so as to sandwich the left and right side surfaces of the adjacent vertebral bodies L1 and L2 by the fixingclaws 74b, respectively, via a plurality ofsharp protrusions 74c ( Piercing) and fixing (interbody space holding process). At this time, the opening / closing operation of each pair ofclamp arms 74, 74 is performed by moving the clamp arm opening /closing pipe 70b backward or forward as described above.
次に、いずれも図示しないが、腹部MN1側から椎体間スペース保持装置70の第1のシャフト部71内に挿入した内視鏡(又は腹腔鏡)を用いて移植ドライバーのドリル又は中空の管状カッター(穿孔器)により椎体L1、L2の間の椎間板スペースM部に椎体固定装置10の本体11の外径より僅かに細い外径の下穴を適宜深さまで穿設する(下穴穿設工程)。Next, although not shown in the figure, a transplant driver drill or a hollow tubular tube is used by using an endoscope (or a laparoscope) inserted into thefirst shaft portion 71 of the interbodyspace holding device 70 from the abdominal part MN1 side. With a cutter (perforator), a pilot hole having an outer diameter slightly narrower than the outer diameter of themain body 11 of the vertebralbody fixing device 10 is drilled to an appropriate depth in the intervertebral disc space M between the vertebral bodies L1, L2. Installation process).
前記下穴穿設工程後、本体嵌入ドライバー80の先端係合部83に本体11の後端係合部29を係合した状態で腹部MN1側から椎体間スペース保持装置70の第1のシャフト部71内に挿入し、本体11を押圧及び回転させて椎間板スペースM部の前記下孔の所定位置までねじ込み嵌入させて固定する(本体嵌入工程)。このとき本体11は、図8に示すように、雄ねじ14、15の外面頭頂部が椎体L1、L2の対向面L1a、L2a部に食い込み係合して螺入される。After the pilot hole drilling step, the first shaft of the interbodyspace holding device 70 from the abdomen MN1 side with the rearend engaging portion 29 of themain body 11 engaged with the frontend engaging portion 83 of the mainbody insertion driver 80. It is inserted into theportion 71, and themain body 11 is pressed and rotated to be screwed and fixed to a predetermined position of the lower hole in the intervertebral disc space M (main body inserting step). At this time, as shown in FIG. 8, themain body 11 is screwed into the outer surface tops of themale screws 14 and 15 by biting into and engaging with the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
次いで、図8、9に示すように、押圧ねじドライバー90の先端係合部93に押圧ねじ40の後端係合部44を係合した状態で腹部MN1側から本体嵌入ドライバー80のシャフト部81内に挿入し、押圧ねじ40を椎体L1、L2間に嵌入し固定した本体11の後端面13の雌ねじ部16に挿入し押圧しながら回転してねじ込み、雄ねじ部41の先端43面で1対のピン30、30の後端31、31面を押圧してピン30、30の先端32、32側をそれぞれ傾斜角Θ1、Θ2のガイド孔17、18に沿って案内し順次屈曲させながら対向面L1a、L2a部から椎体L1、L2内に傾斜して差込み固定する(ピン差込み固定工程)。このとき、本体嵌入ドライバー80の把持部82を回転しないように別途いずれも図示しない人手又は機械的回転拘束手段により十分押圧して保持しながら、押圧ねじ40をキャップ42連設面が本体11の後端面13に当接する所定トロークまで雌ねじ16内に螺入する。Next, as shown in FIGS. 8 and 9, theshaft portion 81 of thebody insertion driver 80 from the abdomen MN <b> 1 side in a state where the rearend engagement portion 44 of thepress screw 40 is engaged with the frontend engagement portion 93 of thepress screw driver 90. It is inserted into the internal threadedportion 16 of therear end surface 13 of themain body 11 which is inserted and fixed between the vertebral bodies L1 and L2, and is rotated and screwed in while pressing, and 1 at thetip 43 surface of the male threadedportion 41. The rear surfaces 31, 31 of the pair ofpins 30, 30 are pressed so that thetips 32, 32 side of thepins 30, 30 are guided along the guide holes 17, 18 of the inclination angles Θ1, Θ2, respectively, and are bent sequentially. The surfaces L1a and L2a are inclined and inserted into the vertebral bodies L1 and L2 (pin insertion and fixing step). At this time, thepress screw 40 is held by thecap 42 continuous surface of themain body 11 while being sufficiently pressed and held by hand or mechanical rotation restraining means (not shown) so as not to rotate the grippingportion 82 of the mainbody insertion driver 80. Screw into theinternal thread 16 up to a predetermined trowel contacting therear end face 13.
このようにキャップ42は、最終的に本体11の後端面13に当接することにより、本体11内部への押圧ねじ40の所定ストロークのねじ込み代が規定されるとともに押圧ねじ40の逆回転摩擦力がアップするため押圧ねじ40の逆回転防止効果及びこれによるピン30の抜け止め効果を有する。In this way, thecap 42 finally comes into contact with therear end surface 13 of themain body 11, thereby defining the screwing allowance of thepressing screw 40 into themain body 11 for a predetermined stroke and the reverse rotational frictional force of thepressing screw 40. Therefore, it has the effect of preventing the reverse rotation of thepressing screw 40 and the effect of preventing thepin 30 from coming off.
以上説明したように、椎体間固定装置10は椎体L1、L2間の適正な間隔に適合する外形を有する小型であり、本体11を椎体L1、L2間に螺入した後に押圧ねじ40を本体11の雌ねじ16にねじ込むだけで押圧されたピン30の先端32からガイド孔17、18に沿って屈曲され椎体L1、L2内に差込み固定される簡潔な構成であることから、腹腔鏡を併用して全て主軸C1方向からの一軸回りのねじ込み操作のみで容易に短時間で椎体間固定処置を行うことができる。As described above, theinterbody fusion device 10 is a small size having an outer shape adapted to an appropriate distance between the vertebral bodies L1 and L2, and after themain body 11 is screwed between the vertebral bodies L1 and L2, thepressing screw 40 is used. Is simply bent into thefemale screw 16 of themain body 11 and is bent along the guide holes 17 and 18 from thetip 32 of thepin 30 that is pressed, and is inserted into the vertebral bodies L1 and L2 and fixed. Thus, the interbody fusion treatment can be easily performed in a short time only by screwing around one axis from the direction of the main axis C1.
このようにして、本発明の椎体間固定外科手術システム、外科手術方法及び椎体間スペース保持装置は、従来の椎体間固定外科手術に比べて手術規模が大幅に縮小化されるとともに手術時間及び回復期間とも大幅に短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担を著しく軽減することができる。そして、椎体L1、L2内に差込まれ固定されたピン30により本体11の適正位置からの後退や回転を防止することができ、椎体間固定の信頼性が確保されるとともに、椎体間固定構造及び操作が大幅に簡潔化及びコンパクト化され、操作性及び経済性とも一層有利となる。As described above, the interbody fusion surgery system, the surgical method, and the interbody space holding device of the present invention are greatly reduced in operation scale as compared with the conventional interbody fusion surgery, and operated. Since both the time and the recovery period can be greatly shortened, the physical and mental burdens of medical staff including patients and doctors, surgical invasion of patients, and economic burdens can be significantly reduced. Then, thepin 30 inserted and fixed in the vertebral bodies L1 and L2 can prevent thebody 11 from retreating or rotating from the proper position, and the intervertebral body fixing reliability is ensured. The intermediate fixing structure and operation are greatly simplified and compact, and the operability and economy are more advantageous.