CN106551734A - The lumbar intervertebral fusion fixing device that a kind of automatic screw is fixed - Google Patents
The lumbar intervertebral fusion fixing device that a kind of automatic screw is fixed Download PDFInfo
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- 230000004927 fusion Effects 0.000 title claims abstract description 37
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- 229920002530 polyetherether ketone Polymers 0.000 claims abstract description 5
- 238000003384 imaging method Methods 0.000 claims abstract description 4
- 239000000463 material Substances 0.000 claims abstract description 3
- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 claims abstract 2
- 238000010079 rubber tapping Methods 0.000 claims description 31
- 210000000988 bone and bone Anatomy 0.000 claims description 17
- 210000004705 lumbosacral region Anatomy 0.000 claims description 4
- 210000003484 anatomy Anatomy 0.000 claims description 3
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- 206010050296 Intervertebral disc protrusion Diseases 0.000 description 2
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- 208000008035 Back Pain Diseases 0.000 description 1
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- 206010057765 Procedural complication Diseases 0.000 description 1
- 208000007103 Spondylolisthesis Diseases 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
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Abstract
Description
技术领域technical field
本发明属于医疗器械技术领域,具体涉及一种自动螺钉固定的腰椎椎间融合固定装置。The invention belongs to the technical field of medical devices, and in particular relates to an automatic screw-fixed lumbar intervertebral fusion fixation device.
背景技术Background technique
腰椎椎体间融合术广泛应用于腰椎间盘退变性疾病,如腰椎间盘突出症、腰椎管狭窄症、腰椎滑脱以及腰椎退变性侧弯等。较传统的术式包括后路腰椎椎体间融合术(TLIF及PLIF)和前路腰椎椎体间融合(ALIF)。后路融合手术虽然疗效确切、融合率较高,但其仍存在一些不足,如剥离椎旁肌引起的肌肉去神经化以及慢性腰痛,椎管内外及神经根周围组织粘连与瘢痕形成,且椎间盘切除范围较小致髓核组织残留、腰椎间盘突出复发等。而前路腰椎椎体间融合也因腹部各种器官干扰而风险高。近年来随着微创手术技术的发展,经微创通道下进行的腰椎融合固定术越来越受欢迎,包括侧方入路腰椎融合固定术(DLIF)和斜前方入路腰椎融合固定术(OLIF)。部分腰椎严重失稳患者,仅仅置入融合器,其抗旋转力学性能较差,可发生融合器的移位,常常需要配合侧路的钉棒或钉板使用。但使用钉板或者钉棒辅助固定,定位难度大,操作繁琐,腰神经常跨越植入物表面,会刺激腰神经引起神经损害,且在临床上仍可观察到联合应用钉棒或者钉板系统患者发生融合器移位。Lumbar interbody fusion is widely used in lumbar degenerative disc diseases, such as lumbar disc herniation, lumbar spinal stenosis, spondylolisthesis, and lumbar degenerative scoliosis. The more traditional surgical methods include posterior lumbar interbody fusion (TLIF and PLIF) and anterior lumbar interbody fusion (ALIF). Although the posterior fusion surgery has a definite curative effect and a high fusion rate, it still has some shortcomings, such as muscle denervation caused by dissection of the paraspinal muscles and chronic low back pain, adhesion and scarring of tissues inside and outside the spinal canal and around nerve roots, and intervertebral disc The resection range is small, resulting in residual nucleus pulposus tissue and recurrence of lumbar disc herniation. The anterior lumbar interbody fusion also has a high risk due to the interference of various abdominal organs. In recent years, with the development of minimally invasive surgical techniques, lumbar fusion and fixation through minimally invasive channels has become more and more popular, including lateral approach lumbar fusion and fixation (DLIF) and oblique anterior approach lumbar fusion and fixation ( OLIF). For some patients with severe lumbar instability, only fusion cages are placed, which have poor anti-rotation mechanical properties, and displacement of fusion cages may occur, and often need to be used in conjunction with lateral screw rods or nail plates. However, the use of nail-plate or nail-rod auxiliary fixation is difficult to locate and cumbersome to operate. The lumbar nerve often crosses the surface of the implant, which will stimulate the lumbar nerve and cause nerve damage, and it can still be observed in clinical practice that the joint application of nail-rod or nail-plate system Patient has fusion cage displacement.
发明内容Contents of the invention
本发明的目的在于提供一种自动螺钉固定的腰椎椎间融合固定装置。The object of the present invention is to provide an automatic screw-fixed lumbar intervertebral fusion fixation device.
本发明的技术方案如下:Technical scheme of the present invention is as follows:
一种自动螺钉固定的腰椎椎间融合固定装置,包括:An automatic screw-fixed lumbar intervertebral fusion fixation device, comprising:
一本体,PEEK材质,长度与人体腰椎椎体的冠状斜面的长度一致,宽度为人体腰椎椎体的矢状面宽度的70~80%;其侧壁的形状贴合人体解剖机构,包括一侧壁前段、一侧壁中段和一侧壁后段,该侧壁前段的上边缘和下边缘之间的距离从后向前沿本体的长度方向的轴线逐渐缩小,侧壁中段的上边缘和下边缘均为中间高两边底的弧形,侧壁后段的上边缘与下边缘与人腰椎的冠状水平面的夹角为10~30度;本体的上顶面和下底面均设有从前往后连续排列的三角形的定位齿,该定位齿的齿深为0.8~1.0mm,上述三角形的定位齿的前角为30度,后角为60度,顶角为90度;本体具有上下贯通的一前骨料填充腔和一后骨料填充腔,该前骨料填充腔和后骨料填充腔通过一中央壁相隔,前骨料填充腔的两侧壁具有贯通的二前植骨窗,后骨料填充腔的两侧壁具有贯通的二后植骨窗;一钛合金材质的显影件设于本体上,且距本体的前端1.0~1.5mm处,用以在成像过程中作为结构标记;One body, made of PEEK, the length is consistent with the length of the coronal slope of the human lumbar vertebral body, and the width is 70-80% of the sagittal plane width of the human lumbar vertebral body; the shape of the side wall fits the human anatomy, including one side The front section of the wall, the middle section of the side wall and the rear section of the side wall, the distance between the upper edge and the lower edge of the front section of the side wall gradually decreases from the rear to the axis of the length direction of the front body, and the upper edge and lower edge of the middle section of the side wall They are all arc-shaped with a middle height and two bottoms. The angle between the upper and lower edges of the rear section of the side wall and the coronal horizontal plane of the human lumbar spine is 10-30 degrees; Arranged triangular positioning teeth, the tooth depth of the positioning teeth is 0.8 ~ 1.0mm, the front angle of the above-mentioned triangular positioning teeth is 30 degrees, the rear angle is 60 degrees, and the top angle is 90 degrees; the body has a front through up and down. Aggregate filling cavity and a rear aggregate filling cavity, the front aggregate filling cavity and the rear aggregate filling cavity are separated by a central wall, the two side walls of the front aggregate filling cavity have two front bone graft windows through, and the rear bone The two side walls of the material filling cavity have two through bone grafting windows; a titanium alloy developing part is set on the main body, and is 1.0-1.5 mm away from the front end of the main body, which is used as a structural mark during the imaging process;
一固定件,钛合金材质,其具有一向上向内倾斜的上自攻螺纹通孔和一向下向内倾斜的下自攻螺纹通孔,该上自攻螺纹通孔和下自攻螺纹通孔与水平面的夹角均为30±10°,与矢状面的夹角均为10±2.5°;A fixing piece, made of titanium alloy, has an upper self-tapping threaded through hole inclined upwards and inwards and a lower self-tapping threaded through hole inclined downwards and inwards, the upper self-tapping threaded through hole and the lower self-tapping threaded through hole The included angle with the horizontal plane is 30±10°, and the included angle with the sagittal plane is 10±2.5°;
该固定件与本体的尾端相连。The fixing part is connected with the tail end of the body.
在本发明的一个优选实施方案中,所述本体的上顶面和下底面的后部的二边缘之间的距离从前往后沿本体的长度方向的轴线逐渐缩小。In a preferred embodiment of the present invention, the distance between the upper top surface and the rear two edges of the lower bottom surface of the body gradually decreases from front to back along the axis of the length direction of the body.
在本发明的一个优选实施方案中,所述本体的长度为30~45mm,宽度为10~15mm。In a preferred embodiment of the present invention, the length of the body is 30-45mm, and the width is 10-15mm.
进一步优选的,所述侧壁中段的最大宽度为10至15mm,最小宽度小于10mm且大于等于7mm。Further preferably, the maximum width of the middle section of the side wall is 10 to 15 mm, and the minimum width is less than 10 mm and greater than or equal to 7 mm.
在本发明的一个优选实施方案中,所述前植骨窗的长度为4~5mm,宽度为3~4mm。In a preferred embodiment of the present invention, the length of the bone graft window is 4-5 mm, and the width is 3-4 mm.
在本发明的一个优选实施方案中,所述后植骨窗的长度为4~5mm,宽度为3~4mm。In a preferred embodiment of the present invention, the length of the rear bone graft window is 4-5 mm, and the width is 3-4 mm.
在本发明的一个优选实施方案中,所述上自攻螺纹通孔和下自攻螺纹通孔上均设有一弹性限位件。In a preferred embodiment of the present invention, both the upper self-tapping thread through hole and the lower self-tapping thread through hole are provided with an elastic stopper.
在本发明的一个优选实施方案中,所述固定件上设有一适配上自攻螺纹通孔的上限位挡片,用以嵌入上椎体中。In a preferred embodiment of the present invention, the fixing member is provided with an upper limit blocking piece adapted to the upper self-tapping threaded through hole for embedding into the upper vertebral body.
在本发明的一个优选实施方案中,所述固定件上设有一适配下自攻螺纹通孔的下限位挡片,用以嵌入下椎体中。In a preferred embodiment of the present invention, the fixing member is provided with a lower limit blocking piece adapted to the lower self-tapping threaded through hole for embedding into the lower vertebral body.
在本发明的一个优选实施方案中,所述固定件的中部设有适配夹持器械的卡槽。In a preferred embodiment of the present invention, the middle part of the fixing member is provided with a slot adapted to hold an instrument.
本发明的有益效果:Beneficial effects of the present invention:
1、本发明的自动螺钉固定的腰椎椎间融合固定装置可用于微创通道置入,该自动螺钉固定的腰椎椎间融合固定装置可连通本体和固定件一起置入,防止发生不必要的移位,固定牢固,一起置入还可简化手术步骤,缩短手术时间,降低手术难度,减少患者的术中损伤。1. The automatic screw-fixed lumbar intervertebral fusion fixation device of the present invention can be used for minimally invasive channel insertion, and the automatic screw-fixed lumbar intervertebral fusion fixation device can be connected to the main body and the fixation piece to prevent unnecessary displacement. Position, fixed firmly, together can also simplify the operation steps, shorten the operation time, reduce the difficulty of operation, and reduce the intraoperative injury of patients.
2、本发明的上下自攻螺纹通孔上具有弹性限位件,可在置入螺钉时被压回,并在螺钉完全旋入之后再次弹出,可卡在螺钉的头端外缘,防止螺钉退出,降低患者二次手术的风险。2. The upper and lower self-tapping threaded through holes of the present invention have elastic limiters, which can be pressed back when the screw is inserted, and pop out again after the screw is completely screwed in, and can be stuck on the outer edge of the head end of the screw to prevent the screw from Withdrawal, reducing the risk of secondary surgery for patients.
3、所述固定件的中部设有适配夹持器械的卡槽,可以和置入辅助工具相结合,方便在微创通道内置入本发明。3. The middle part of the fixing member is provided with a slot suitable for clamping instruments, which can be combined with an insertion auxiliary tool to facilitate the insertion of the present invention in a minimally invasive channel.
4、本发明的本体的上顶面和下底面均设有从前往后连续排列的三角形的定位齿,上述三角形的定位齿的前角为30度,后角为60度,顶角为90度,这样便于减小融合器的置入的阻力,又可提供初始稳定性,防止融合器脱出。4. The upper top surface and the lower bottom surface of the body of the present invention are provided with triangular positioning teeth arranged continuously from front to back. The front angle of the above-mentioned triangular positioning teeth is 30 degrees, the rear angle is 60 degrees, and the top angle is 90 degrees. , so that it is convenient to reduce the resistance of the insertion of the fusion device, and can also provide initial stability to prevent the fusion device from coming out.
5、本发明的固定件和本体一体置入椎间隙中,再辅以自攻螺钉固定,避免了在椎体外进行钉板、钉棒系统的固定,可以做到零切迹,既不影响临近关节的活动,也不会损伤周围的组织脏器。5. The fixing part and the main body of the present invention are integrated into the intervertebral space, and then fixed with self-tapping screws, which avoids the fixing of the nail plate and nail rod system outside the vertebral body, and can achieve zero notch without affecting the Activities near the joints will not damage the surrounding tissues and organs.
6、本发明可在微创手术下通过侧路或者斜前路置入,相对于传统手术可以最大限度保留椎间小关节、棘突、棘间韧带、后纵韧带,不需要大范围的剥离腰背肌,其中斜前路置入不需要剥离腰大肌,不需要术中进行神经电生理监测,维持了腰椎生理和力学稳定,患者术后恢复快,脊柱稳定良好。6. The present invention can be placed through a lateral or anterior oblique approach under minimally invasive surgery. Compared with traditional surgery, the intervertebral facet joints, spinous processes, interspinous ligaments, and posterior longitudinal ligaments can be preserved to the greatest extent without extensive stripping The lumbar dorsal muscle, in which the oblique anterior approach does not require stripping of the psoas major muscle, does not require intraoperative neurophysiological monitoring, and maintains the physiological and mechanical stability of the lumbar spine. The patient recovers quickly after surgery and the spine is stable.
附图说明Description of drawings
图1本发明的立体结构示意图。Fig. 1 is a schematic diagram of the three-dimensional structure of the present invention.
图2为本发明的侧视图。Figure 2 is a side view of the present invention.
图3为本发明的俯视图。Fig. 3 is a top view of the present invention.
具体实施方式detailed description
以下通过具体实施方式结合附图对本发明的技术方案进行进一步的说明和描述。The technical solutions of the present invention will be further illustrated and described below through specific embodiments in conjunction with the accompanying drawings.
如图1所示,一种自动螺钉固定的腰椎椎间融合固定装置,包括一PEEK(聚醚醚酮)材质的本体1和一钛合金材质的固定件2,该固定件2与本体1的尾端相连,具体的该固定件2通过卡槽结构与本体1的尾端相连。As shown in Figure 1, an automatic screw-fixed lumbar intervertebral fusion fixation device includes a body 1 made of PEEK (polyetheretherketone) and a fixing part 2 made of titanium alloy, the fixing part 2 and the body 1 The tail ends are connected, specifically, the fixing part 2 is connected with the tail end of the body 1 through a slot structure.
如图1至图3所示,本体1具有上下贯通的一前骨料填充腔11和一后骨料填充腔12,该前骨料填充腔11和后骨料填充腔12通过一中央壁13相隔,前骨料填充腔11的两侧壁具有贯通的二前植骨窗110,后骨料填充腔12的两侧壁具有贯通的二后植骨窗120,前植骨窗110和后植骨窗120的形状均为类椭圆形(中部上下边缘平行,两端通过半圆形相连),长度均为4~5mm,宽度均为3~4mm,可以为位于本发明中的骨质提供营养及血液供应,为骨性融合提供良好的生理条件;一钛合金材质的显影件3设于本体2上,且距本体2的前端1.0~1.5mm处,用以在成像过程中作为结构标记;As shown in Figures 1 to 3, the main body 1 has a front aggregate filling cavity 11 and a rear aggregate filling cavity 12 that pass through up and down, and the front aggregate filling cavity 11 and the rear aggregate filling cavity 12 pass through a central wall 13 The two side walls of the front aggregate filling cavity 11 have two through bone graft windows 110, the two side walls of the rear aggregate filling cavity 12 have two through bone graft windows 120, the front bone graft windows 110 and the rear bone graft The shape of the bone window 120 is all oval-like (the upper and lower edges of the middle part are parallel, and the two ends are connected by a semicircle), the length is 4-5mm, and the width is 3-4mm, which can provide nutrition for the bone in the present invention. and blood supply to provide good physiological conditions for bone fusion; a titanium alloy developing part 3 is set on the body 2, and is 1.0-1.5 mm away from the front end of the body 2, and is used as a structural marker during the imaging process;
本体1的长度与人体腰椎椎体的冠状斜面的长度一致,优选30~45mm,宽度为人体腰椎椎体的矢状面宽度的70~80%并尽量适应微创通道能容纳的宽度大小,优选10~15mm;The length of the main body 1 is consistent with the length of the coronal inclined plane of the human lumbar vertebral body, preferably 30-45mm, and the width is 70-80% of the sagittal plane width of the human lumbar vertebral body and is adapted to the width that the minimally invasive channel can accommodate, preferably 10~15mm;
如图2所示,本体1的侧壁的形状贴合人体解剖机构,包括一侧壁前段14、一侧壁中段15和一侧壁后段16,该侧壁前段14的上边缘和下边缘之间的距离从后向前沿本体1的长度方向的轴线逐渐缩小,侧壁中段15的上边缘和下边缘均为中间高两边底的弧形(最大宽度为10至15mm,最小宽度小于10mm且大于等于7mm),侧壁后段16的上边缘与下边缘与人腰椎的冠状水平面的夹角为10~30度,可以方便主体植入腰椎关节间隙,阻力小,易于植入;As shown in Figure 2, the shape of the side wall of the main body 1 conforms to the anatomy of the human body, including a front section 14 of a side wall, a middle section 15 of a side wall and a rear section 16 of a side wall, and the upper and lower edges of the front section 14 of the side wall The distance between them is gradually reduced from the rear to the axis of the length direction of the front body 1, and the upper and lower edges of the middle section 15 of the side wall are arc-shaped (the maximum width is 10 to 15mm, the minimum width is less than 10mm and greater than or equal to 7mm), the angle between the upper edge and the lower edge of the posterior section 16 of the side wall and the coronal horizontal plane of the human lumbar spine is 10-30 degrees, which can facilitate the main body to be implanted into the lumbar joint space, with small resistance and easy implantation;
如图1至图3所示,本体1的上顶面和下底面均设有从前往后连续排列的三角形的定位齿17,该定位齿17的齿深为0.8~1.0mm,上述三角形的定位齿17的前角为30度,后角为60度,顶角为90度;且本体1的上顶面和下底面的后部的二边缘之间的距离从前往后沿本体1的长度方向的轴线逐渐缩小,也可以减小植入的阻力,还可以避免损伤周围的组织器官;As shown in Figures 1 to 3, the upper top surface and the lower bottom surface of the body 1 are provided with triangular positioning teeth 17 arranged continuously from front to back, and the tooth depth of the positioning teeth 17 is 0.8-1.0 mm. The front angle of the tooth 17 is 30 degrees, the rear angle is 60 degrees, and the top angle is 90 degrees; The axis of the implant gradually narrows, which can also reduce the resistance of implantation and avoid damage to surrounding tissues and organs;
如图1所示,固定件2具有一向上向内倾斜的上自攻螺纹通孔21和一向下向内倾斜的下自攻螺纹通孔22,该上自攻螺纹通孔21和下自攻螺纹通孔22与水平面的夹角均为30±10°,与矢状面的夹角均为10±2.5°,同时,固定件2上设有一适配上自攻螺纹通孔21的上限位挡片23和一适配下自攻螺纹通孔22的下限位挡片24,在本发明植入的过程中,可将该上限位挡片23和下限位挡片24嵌入上下椎体中,一方面防止本发明过深打入椎体,一方面可以增加本发明的抗旋转稳定性;所述上自攻螺纹通孔21和下自攻螺纹通孔22上均设有一弹性限位件25,在置入自攻螺钉时该弹性限位件25被挤压让位,并在螺钉完全旋入之后复位,可卡在自攻螺钉的头端外缘,防止自攻螺钉退出,优选的,自攻螺钉相对于钛合金固定板的角度可调;此外所述固定件2的中部还优选设有适配夹持器械的卡槽26,可以和相应的辅助工具结合,方便本发明经微创通道置入。上述自攻螺钉优选的直径4mm,长度30~40mm,其钉帽呈圆弧面。As shown in Figure 1, the fixing member 2 has an upper self-tapping thread through hole 21 inclined upward and inward and a lower self-tapping thread through hole 22 inclined downward and inward, the upper self-tapping thread through hole 21 and the lower self-tapping thread The included angle between the threaded through hole 22 and the horizontal plane is 30±10°, and the included angle with the sagittal plane is 10±2.5°. At the same time, the fixing member 2 is provided with an upper limit for the self-tapping threaded through hole 21 The blocking piece 23 and a lower limiting blocking piece 24 adapted to the lower self-tapping threaded through hole 22, during the implantation process of the present invention, the upper limiting blocking piece 23 and the lower limiting blocking piece 24 can be embedded in the upper and lower vertebral bodies, On the one hand, it prevents the present invention from penetrating too deeply into the vertebral body, and on the other hand, it can increase the anti-rotation stability of the present invention; the upper self-tapping thread through hole 21 and the lower self-tapping thread through hole 22 are provided with an elastic limiter 25 , when the self-tapping screw is inserted, the elastic limiter 25 is squeezed out of place, and resets after the screw is completely screwed in, and can be stuck on the outer edge of the head end of the self-tapping screw to prevent the self-tapping screw from withdrawing. Preferably, The angle of the self-tapping screw relative to the titanium alloy fixing plate is adjustable; in addition, the middle part of the fixing part 2 is also preferably provided with a draw-in slot 26 suitable for clamping instruments, which can be combined with corresponding auxiliary tools to facilitate the minimally invasive operation of the present invention. Channel placement. The preferred diameter of the above-mentioned self-tapping screw is 4mm, the length is 30-40mm, and its cap is in the form of an arcuate surface.
以上所述,仅为本发明的较佳实施例而已,故不能依此限定本发明实施的范围,即依本发明专利范围及说明书内容所作的等效变化与修饰,皆应仍属本发明涵盖的范围内。The above is only a preferred embodiment of the present invention, so the scope of the present invention cannot be limited accordingly, that is, equivalent changes and modifications made according to the patent scope of the present invention and the content of the specification should still be covered by the present invention In the range.
Claims (10)
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