CN102240234B - Adjustable artificial cervical vertebra and intervertebral connecting complex - Google Patents
Adjustable artificial cervical vertebra and intervertebral connecting complex Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
本发明涉及一种可调式人工颈椎及椎间连接复合体,包括椎体部件以及分别通过球关节结构连接于椎体部件上下端的两个终板部件;所述椎体部件由上椎体部件和下椎体部件组成,所述上椎体部件和下椎体部件轴向通过螺纹连接;在所述上椎体部件和下椎体部件的侧周壁上径向对应设有若干螺孔,在上椎体部件和下椎体部件的螺孔间还设有一个长度固定螺钉;所述两个终板部件上分别设有终板部件固定螺钉。该连接复合体同时具备人工椎体的支撑功能和人工椎间盘的活动性能、长度可调节,能够实现颈椎前路手术后的即刻稳定,能起到支撑作用,也可以实现颈椎前路术后即刻运动功能重建,使其活动性能与正常颈椎高度仿生。
The invention relates to an adjustable artificial cervical vertebra and an intervertebral connection complex, which includes a vertebral body part and two endplate parts respectively connected to the upper and lower ends of the vertebral body part through a ball joint structure; the vertebral body part consists of an upper vertebral body part and Composed of lower vertebral body parts, the upper vertebral body part and the lower vertebral body part are axially connected by threads; a number of screw holes are radially correspondingly provided on the side walls of the upper vertebral body part and the lower vertebral body part. A length fixing screw is also provided between the screw holes of the vertebral body part and the lower vertebral body part; the two end plate parts are respectively provided with end plate part fixing screws. The connection complex has both the support function of the artificial vertebral body and the activity performance of the artificial intervertebral disc, and its length can be adjusted. It can achieve immediate stability after anterior cervical surgery, can play a supporting role, and can also realize immediate movement after anterior cervical surgery. Functional reconstruction, so that its activity performance is highly bionic with the normal cervical spine.
Description
技术领域 technical field
本发明属于医用假体制造技术领域,涉及一种长度可调的人工颈椎椎体和椎间连接的复合体。The invention belongs to the technical field of medical prosthesis manufacturing, and relates to a composite body of an artificial cervical vertebral body and an intervertebral connection with adjustable length.
背景技术 Background technique
由于人口老龄化,伏案工作者及使用电脑者比例增长,交通事故发生率增高等因素,颈椎伤患(如颈椎病,颈椎骨折,颈椎肿瘤等)的人数随之增长。对于各种颈椎疾病患者的手术治疗,尤其是颈椎间盘突出导致的颈椎病及颈椎骨折,手术的关键有二:一是减压。需要减除压迫脊髓或者神经根的因素,以促进术后神经功能的早日恢复。二是稳定。通过各种类型的融合手术,采用不同的植入材料(如自体骨、异体骨以及人工椎体等)实现术后手术节段的长期稳定性。其中,前路椎间盘髓核摘除椎体次全切除减压并椎间融合术是目前最主要的,也是最具有应用优势的手术术式。其优点包括减压较单纯椎间盘摘除术彻底,融合率高等。前路椎间融合的方法包括自体骨,异体骨及人工椎体植骨融合。由于自体骨植骨具有良好的骨诱导性、骨传导性和骨形成性,所以成为植骨融合的金标准。自体骨植骨融合术的优点是没有免疫原性,且融合速度快。缺点有术后高度丢失率高,且造成取骨区的二次损伤(如供骨区的出血、骨折、感染等)。异体骨植骨避免了上述缺点,但存在免疫原性,以及融合速度较慢(常常需要6个月甚至9个月以上)。Due to the aging of the population, the increase in the proportion of desk workers and computer users, and the increase in the incidence of traffic accidents, the number of cervical spine injuries (such as cervical spondylosis, cervical spine fractures, cervical spine tumors, etc.) has increased accordingly. For the surgical treatment of patients with various cervical spondylosis, especially cervical spondylosis and cervical spine fractures caused by cervical disc herniation, there are two keys to surgery: one is decompression. It is necessary to reduce the factors that compress the spinal cord or nerve roots to promote the early recovery of neurological function after surgery. The second is stability. Through various types of fusion surgery, different implant materials (such as autologous bone, allogeneic bone, and artificial vertebral body, etc.) are used to achieve long-term stability of the surgical segment after surgery. Among them, anterior discectomy and subtotal corpectomy decompression followed by intervertebral fusion is currently the most important and most advantageous surgical procedure. Its advantages include that the decompression is more complete than the simple discectomy, and the fusion rate is higher. The methods of anterior intervertebral fusion include autologous bone, allograft bone and artificial vertebral bone graft fusion. Because of its good osteoinductivity, osteoconductivity and bone formation, autologous bone graft has become the gold standard for bone graft fusion. The advantages of autologous bone graft fusion are no immunogenicity and fast fusion. Disadvantages include a high postoperative height loss rate and secondary damage to the bone harvesting area (such as bleeding, fracture, infection, etc.) in the bone donor area. Allogeneic bone graft avoids the above disadvantages, but has immunogenicity and slow fusion speed (often takes 6 months or even more than 9 months).
为了克服自体骨和异体骨移植的上述缺点,人们一直在寻找脊柱手术后的替代物,由此诞生了人工椎体。1969年,Hamdi首次报告腰2浆细胞瘤和转移性腺癌病人施行椎体肿瘤切除,并以人工假体替代病变椎体(Hamdi,F A.Prosthesis for an excised lumbar vertebra:apreliminary report.Can Med Assoc J,1969,100,12:576-80.)。根据材料可分为金属人工椎体、新型复合材料人工椎体及其它材料人工椎体三大类。从结构及功能特点看主要可分为单纯支撑型,撑开固定型和可调固定型三种类型。单纯支撑型人工椎体:支撑型人工椎体与上下椎体的固定主要是依赖其内填充骨水泥,目的是填充椎体切除后的骨缺损,固定作用较差。可撑开固定型人工椎体:这类人工椎体大多是通过尖刺状物与上下椎体相固定,能达到脊柱的即刻稳定性。钛网是最常使用的可撑开固定型人工椎体,广泛应用于椎体的重建,但钛网本身长度固定且不能调节,因此对椎体的选择很严谨,否则难以恢复理想的椎体高度,而且有脱落的危险。可调固定型人工椎体:国内外学者研制了具有各种特色的可调固定型人工椎体,应用于临床并取得了一定的疗效。如Synex人工椎体,为钛质中空网状结构,长度可调节,Knop等将其用于胸腰椎前柱损伤的重建,可提供良好的脊柱三维稳定性。但由于Synex人工椎体长度调整后,从后路植入困难,技术要求高,因此一般行前路或者前后联合入路,手术创伤大、时间久(Knop,Christian;Lange,Uta;Reinhold,Maximilian;Blauth,Michael.Vertebralbody replacement with Synex in combined posteroanterior surgery fortreatment of thoracolumbar injuries.Oper Orthop Traumatol.2005,17(3):249-80.)。赵定麟等(赵定麟,陈德上,赵杰,等。可调式中空人工椎体的研制与临床应用。中华骨科杂志,2001,21:222-224.)研制的中空可调式钛合金人工椎体,可以调节人工椎体的长度,达到理想的恢复椎体高度的目的,因为是中空结构,其内部可以植骨,使假体与椎体形成永久骨性融合。但仅有尖刺状物与上下椎体接触固定,且该假体呈刚性固定,存在内植骨的应力遮挡和骨吸收等问题。In order to overcome the above-mentioned shortcomings of autologous bone and allograft bone graft, people have been looking for a substitute after spinal surgery, thus the artificial vertebral body was born. In 1969, Hamdi reported for the first time that patients with lumbar 2 plasmacytoma and metastatic adenocarcinoma underwent vertebral tumor resection and replaced the diseased vertebra with artificial prosthesis (Hamdi, F A. Prosthesis for an excised lumbar vertebra: apreliminary report. Can Med Assoc J, 1969, 100, 12:576-80.). According to the material, it can be divided into three categories: metal artificial vertebral body, new composite material artificial vertebral body and other materials artificial vertebral body. From the perspective of structure and functional characteristics, it can be divided into three types: simple support type, open fixed type and adjustable fixed type. Simple support type artificial vertebral body: The fixation between the support type artificial vertebral body and the upper and lower vertebral bodies mainly depends on the filling of bone cement in it, the purpose is to fill the bone defect after vertebral body resection, and the fixation effect is poor. Expandable and fixed artificial vertebral body: Most of these artificial vertebral bodies are fixed with the upper and lower vertebral bodies through spikes, which can achieve immediate stability of the spine. Titanium mesh is the most commonly used expandable and fixed artificial vertebral body. It is widely used in the reconstruction of vertebral bodies. However, the length of titanium mesh itself is fixed and cannot be adjusted. Therefore, the selection of vertebral bodies is very strict, otherwise it will be difficult to restore the ideal vertebral body height and there is a risk of falling off. Adjustable and fixed artificial vertebral bodies: Scholars at home and abroad have developed adjustable and fixed artificial vertebral bodies with various characteristics, which have been used clinically and achieved certain curative effects. For example, the Synex artificial vertebral body is a titanium hollow mesh structure with an adjustable length. Knop et al. used it for the reconstruction of thoracolumbar anterior column injuries, which can provide good three-dimensional stability of the spine. However, after the length adjustment of the Synex artificial vertebral body, it is difficult to implant from the posterior approach, and the technical requirements are high, so the anterior approach or combined anterior-posterior approach is generally performed, and the surgical trauma is large and the time is long (Knop, Christian; Lange, Uta; Reinhold, Maximilian Blauth, Michael. Vertebral body replacement with Synex in combined posteroanterior surgery for treatment of thoracolumbar injuries. Oper Orthop Traumatol. 2005, 17(3): 249-80.). Zhao Dinglin et al. (Zhao Dinglin, Chen Deshang, Zhao Jie, etc. Development and clinical application of adjustable hollow artificial vertebral body. Chinese Journal of Orthopedics, 2001, 21: 222-224.) developed a hollow adjustable titanium alloy artificial vertebral body, The length of the artificial vertebral body can be adjusted to achieve the ideal purpose of restoring the height of the vertebral body. Because it is a hollow structure, bone can be grafted inside to form a permanent bone fusion between the prosthesis and the vertebral body. However, only the spikes are fixed in contact with the upper and lower vertebral bodies, and the prosthesis is rigidly fixed, so there are problems such as stress shielding and bone resorption of the implanted bone.
这些人工椎体通过各种形状、材料的调整、改进,以期能够简化手术步骤,减少手术创伤,实现术后的即刻稳定,加快融合速度。但是上述的人工椎体都存在同样的一个问题,就是使用后施术脊柱节段完全丧失了原有的活动性。而这被认为会加速术后颈椎的退行性病变,导致相邻节段颈椎椎间盘突出、椎体骨质增生等。长期随访的结果显示,施行颈椎前路融合手术后,有高达92%的病人出现了临近节段的退变,虽然临床症状并不与X线上的严重程度一致(Goffin,Jan,Geusens,Eric,Vantomme,Nicolaas,et al.Long-term follow-up afterinterbody fusion of the cervical spine.J Spinal DisordTech,2004,17(2):79-85.)。Hilibrand等发现前路融合手术后每年约有2.9%的患者出现了与相邻节段退变有关的临床症状,且经统计学分析认为25.6%的患者在10年内会出现由于相邻节段退变而导致的临床症状。(Hilibrand AS,Carlson GD,Palumbo MA,et al.Radiculopathyand myelopathy at segments adjacent to the site of a p revious anteriorcervical arthrodesis[J].J Bone Joint Surg Am,1999,81(4):519-528.)生物力学实验的结果也证实了施行融合手术后相邻节段的椎间盘内压力增高。动力位的影像学证据也显示融合术后相邻节段椎体的相对活动度加大。这些因素都极有可能促进了融合术后临近节段的退行性变。These artificial vertebral bodies are adjusted and improved through various shapes and materials in order to simplify the operation steps, reduce the operation trauma, achieve immediate postoperative stability and speed up the fusion speed. However, the above-mentioned artificial vertebral bodies all have the same problem, that is, the spinal segment completely loses its original mobility after use. This is considered to accelerate the degeneration of the cervical spine after surgery, leading to disc herniation in the adjacent segment of the cervical spine and hyperosteogeny in the vertebral body. The results of long-term follow-up showed that after anterior cervical fusion surgery, up to 92% of patients had degeneration of adjacent segments, although the clinical symptoms were not consistent with the severity of the X-ray (Goffin, Jan, Geusens, Eric , Vantomme, Nicolaas, et al. Long-term follow-up after interbody fusion of the cervical spine. J Spinal DisordTech, 2004, 17(2): 79-85.). Hilibrand et al. found that about 2.9% of patients had clinical symptoms related to adjacent segment degeneration every year after anterior fusion surgery, and statistical analysis showed that 25.6% of patients would experience symptoms due to adjacent segment degeneration within 10 years. Clinical symptoms caused by changes. (Hilibrand AS, Carlson GD, Palumbo MA, et al. Radiculopathy and myelopathy at segments adjacent to the site of a p previous anterior cervical arthritis[J]. J Bone Joint Surg Am, 1999, 81(4): 519-528.) The results of mechanical experiments also confirmed that the intervertebral disc pressure in the adjacent segments increased after the fusion operation. The imaging evidence of the dynamic position also showed that the relative motion of the vertebral bodies of adjacent segments increased after fusion. These factors are very likely to promote the degeneration of adjacent segments after fusion.
针对融合术后所产生的施术节段活动度丧失以及临近节段的退变等缺点,国内外科学家和医生建立了脊柱非融合手术方式,其理念便是运动保留(motion preservation)。而人工椎间盘置换术(又称椎间盘成形术)便是施行非融合手术的典型代表。目前临床上主要应用的椎间盘有Bryan假体,ProDisc-C假体,Prestige假体,PCM假体等。目前认为,人工椎间盘置换术的最佳指征是单节段,颈椎生理弯曲存在(Sekhon LH.Cervical arthroplasty in the management ofspondylotic myelopathy[J].J SpinalDisord Tech,2003,16(4):307-313)。公认的禁忌征有骨质疏松和椎体间不稳(Wiffield CC,Skrzyp iecD,Jackowski A,et al.Internal stress distribution in cervical intervertebraldiscs:the influence of an artificial cervical joint and simulated anteriorinterbody fusion[J].J Spinal Disord Tech,2003,16(5):441-449.)。虽然各种人工椎间盘的材料、形态各异,但是它们存在的共同的缺点有:一、只能单独置换椎间盘,而对合并椎体病变无能为力(比如椎体肿瘤,以及需要对椎体进行减压的手术)。二、多数学者不认同多节段的椎间盘置换术,尤其是相邻的两个椎间盘同时进行置换术。Aiming at the disadvantages of loss of mobility of the operating segment and degeneration of adjacent segments after fusion, scientists and doctors at home and abroad have established non-fusion spinal surgery with the concept of motion preservation. Artificial disc replacement (also known as intervertebral disc plastic surgery) is a typical representative of non-fusion surgery. At present, the main clinically used intervertebral discs include Bryan prosthesis, ProDisc-C prosthesis, Prestige prosthesis, PCM prosthesis, etc. At present, it is believed that the best indication for artificial intervertebral disc replacement is single-segment cervical spine physiological curvature (Sekhon LH. ). Recognized contraindications are osteoporosis and intervertebral instability (Wiffield CC, Skrzyp iecD, Jackowski A, et al.Internal stress distribution in cervical intervertebraldiscs: the influence of an artificial cervical joint and simulated anterior interbody fusion[J].J Spinal Disord Tech, 2003, 16(5): 441-449.). Although the materials and shapes of various artificial intervertebral discs are different, they have the following common disadvantages: 1. They can only replace the intervertebral disc alone, but they are powerless to merged vertebral body lesions (such as vertebral body tumors, and need to decompress the vertebral body. surgery). 2. Most scholars do not agree with multi-segment intervertebral disc replacement, especially when two adjacent intervertebral discs are replaced at the same time.
综上所述,目前现有的技术不能解决颈椎手术后活动性的问题,尤其是多个节段手术后不能活动的问题,以及由此带来的融合术后相邻节段的退变问题。To sum up, the current existing technology cannot solve the problem of mobility after cervical spine surgery, especially the problem of inability to move after multiple segmental surgery, and the resulting degeneration of adjacent segments after fusion .
因此,本申请研制了以下同时具备人工椎体的支撑功能和人工椎间盘的活动性能的长度可调节的人工颈椎椎体和椎间连接复合体。Therefore, the present applicant has developed the following artificial cervical vertebral body and intervertebral connection complex with adjustable length, which have both the supporting function of the artificial vertebral body and the mobility of the artificial intervertebral disc.
发明内容 Contents of the invention
本发明的目的在于克服上述现有技术的缺点,提供一种可调式人工颈椎及椎间连接复合体,该连接复合体同时具备人工椎体的支撑功能和人工椎间盘的活动性能、长度可调节,能够实现颈椎前路手术后的即刻稳定,能起到支撑作用,也可以实现颈椎前路术后即刻运动功能重建,使其活动性能与正常颈椎高度仿生。The object of the present invention is to overcome the above-mentioned shortcoming of prior art, provide a kind of adjustable artificial cervical vertebra and intervertebral connecting complex, this connecting complex has the supporting function of artificial vertebral body and the activity performance of artificial intervertebral disc at the same time, and the length can be adjusted, It can achieve immediate stability after anterior cervical surgery, can play a supporting role, and can also realize immediate reconstruction of motion function after anterior cervical surgery, making its activity performance and normal cervical spine highly bionic.
本发明的目的是通过以下技术方案来解决的:The purpose of the present invention is solved by the following technical solutions:
这种可调式人工颈椎及椎间连接复合体,包括椎体部件以及分别通过球关节结构连接于椎体部件上下端的两个终板部件;所述椎体部件由上椎体部件和下椎体部件组成,所述上椎体部件和下椎体部件轴向通过螺纹连接;在所述上椎体部件和下椎体部件的侧周壁上径向对应设有若干螺孔,在上椎体部件和下椎体部件的螺孔间还设有一个长度固定螺钉;所述两个终板部件上分别设有终板部件固定螺钉。This adjustable artificial cervical vertebra and intervertebral connection complex includes a vertebral body component and two endplate components connected to the upper and lower ends of the vertebral body component through a ball joint structure; the vertebral body component consists of an upper vertebral body component and a lower vertebral body Composed of components, the upper vertebral body part and the lower vertebral body part are axially connected by threads; a number of screw holes are radially correspondingly provided on the side walls of the upper vertebral body part and the lower vertebral body part, and the upper vertebral body part There is also a length fixing screw between the screw hole of the lower vertebral body part and the screw hole of the lower vertebral body part; the two end plate parts are respectively provided with end plate part fixing screws.
上述球关节结构包括设置在终板部件上的关节球结构以及设置在上椎体部件或下椎体部件端部与所述关节球结构相适应的臼口结构,所述臼口结构的内部空间由处于中心的圆柱空间以及与圆柱空间两侧相贯的半球空间组成;且所述臼口结构的内部大、出口小,将关节球结构包在其内。The above-mentioned ball joint structure includes the joint ball structure arranged on the end plate part and the socket structure arranged at the end of the upper vertebral body part or the lower vertebral body part and adapted to the joint ball structure, and the inner space of the socket structure It is composed of a cylindrical space in the center and a hemispherical space intersecting with both sides of the cylindrical space; and the socket structure has a large inside and a small outlet, and the joint ball structure is wrapped in it.
上述终板部件包括圆板,在圆板的内侧面边沿垂直固定关节球结构,圆板的外侧面在远离所述关节球结构固定位置的边沿处通过相邻的两个螺孔固定有两个所述终板部件固定螺钉;所述终板部件固定螺钉的轴向与所述圆板平面成一定角度。The above-mentioned end plate component includes a circular plate, and the joint ball structure is vertically fixed on the inner surface edge of the circular plate, and two adjacent screw holes are fixed on the outer surface of the circular plate at the edge far away from the fixed position of the joint ball structure. The end plate component is fixed with a screw; the axial direction of the end plate component fixed screw forms a certain angle with the plane of the circular plate.
上述圆板的上表面为磨砂样粗糙结构,并设有生物用羟基磷灰石涂层。The upper surface of the above-mentioned circular plate has a frosted rough structure and is provided with a biological hydroxyapatite coating.
上述羟基磷灰石涂层的厚度为1μm,圆板上表面的后半部分有大小1μm的小齿结构。The thickness of the above-mentioned hydroxyapatite coating is 1 μm, and the rear half of the upper surface of the circular plate has a denticulate structure with a size of 1 μm.
上述圆板的板厚度于固定终板部件固定螺钉的一侧薄、于固定关节球结构的一侧厚,从圆板的侧面看形成一切面,该切面约从终板结构的正中线开始,沿前下方向,形成一个10°的切面,该切面使终板部件与相邻的上椎体形成80°的斜面,与相邻的下椎体形成100°的斜面。The plate thickness of the above-mentioned circular plate is thinner on the side where the endplate component is fixed and the screw is fixed, and thicker on the side where the joint ball structure is fixed. Viewed from the side of the circular plate, a cut plane is formed, and the cut plane begins approximately from the midline of the endplate structure. In the anterior-inferior direction, a 10° cut plane is formed, which causes the endplate component to form an 80° bevel with the adjacent superior vertebral body and a 100° bevel with the adjacent inferior vertebral body.
上述上椎体部件的下部缩颈设有外螺纹,所述下椎体部件上端为设有内螺纹的圆筒结构,所述上椎体部件的下部缩颈端通过螺纹旋入下椎体部件的内螺纹内;在所述上椎体部件和下椎体部件的轴向均匀分布有若干径向螺纹通孔,所述长度固定螺钉能够通过螺纹装入螺纹通孔内以固定上椎体部件和下椎体部件在轴向上的相对位置。The lower constriction of the upper vertebral body part is provided with external threads, the upper end of the lower vertebral body part is a cylindrical structure provided with internal threads, and the lower constriction end of the upper vertebral body part is screwed into the lower vertebral body part by threads In the internal thread of the upper vertebral body part and the lower vertebral body part, there are several radial threaded through holes evenly distributed in the axial direction, and the length fixing screw can be threaded into the threaded through hole to fix the upper vertebral body part relative to the lower vertebral body component in the axial direction.
以上整个复合体最小长度为23mm,最大长度为29mm,调节范围为6mm。The minimum length of the entire complex above is 23mm, the maximum length is 29mm, and the adjustment range is 6mm.
上述终板部件固定螺钉的前端为尖头,所述固定螺钉的后端为螺帽,该固定螺钉的近螺帽端比其近尖头端略粗。The front end of the fixing screw of the end plate part is pointed, the rear end of the fixing screw is a nut, and the end near the nut of the fixing screw is slightly thicker than the end near the tip.
本发明的有益效果是:The beneficial effects of the present invention are:
本发明能够在颈椎前路手术后即刻发挥支撑作用,并通过自带的椎间连接部分替代正常颈椎的运动功能,能够有效的防止融合手术后导致的相邻节段的退变。此外,能够通过植骨和本复合体表面的羟基磷灰石涂层实现生物学融合和长期稳定性。手术难度较小,创伤小,便于推广。由于本复合体本身长度的可调节性,可以减小生产和携带负担,能够适合绝大多数的人群。The present invention can play a supporting role immediately after anterior cervical surgery, and can replace the normal cervical motion function through the self-contained intervertebral connection part, and can effectively prevent the degeneration of adjacent segments after fusion surgery. In addition, biological fusion and long-term stability can be achieved by the bone graft and the hydroxyapatite coating on the surface of the present composite. The operation is less difficult, the trauma is small, and it is easy to promote. Due to the adjustability of the length of the complex itself, the burden of production and carrying can be reduced, and it can be suitable for most people.
附图说明 Description of drawings
图1是本发明的整体结构示意图;Fig. 1 is the overall structural representation of the present invention;
图2是本发明的上椎体部件2结构示意图;Fig. 2 is a schematic structural view of the upper vertebral body part 2 of the present invention;
图3是图2的俯视图;Fig. 3 is the top view of Fig. 2;
图4是本发明的下椎体部件3结构示意图;Fig. 4 is a schematic structural view of the lower vertebral body part 3 of the present invention;
图5是本发明的终板部件1结构示意图图;Fig. 5 is a schematic diagram of the structure of the endplate component 1 of the present invention;
图6是图5的俯视图;Figure 6 is a top view of Figure 5;
其中:1为终板部件;2为上椎体部件;3为下椎体部件;4为终板部件固定螺钉;5为长度固定螺钉;6为关节球结构;7为螺孔;8为小齿结构;9为圆板;10为臼口结构。Among them: 1 is the end plate part; 2 is the upper vertebral body part; 3 is the lower vertebral body part; 4 is the fixing screw of the end plate part; 5 is the length fixing screw; 6 is the joint ball structure; 7 is the screw hole; 8 is the small Tooth structure; 9 is a circular plate; 10 is a socket structure.
具体实施方式 Detailed ways
下面结合附图对本发明做进一步详细描述:The present invention is described in further detail below in conjunction with accompanying drawing:
参见图1,本发明的可调式人工颈椎及椎间连接复合体,包括椎体部件以及分别通过球关节结构连接于椎体部件上下端的两个终板部件1;椎体部件由上椎体部件2和下椎体部件3组成,其中上椎体部件2和下椎体部件3轴向通过螺纹连接;在上椎体部件2和下椎体部件3的侧周壁上径向对应设有若干螺孔,在上椎体部件2和下椎体部件3的螺孔间还设有一个长度固定螺钉5;两个终板部件1上分别设有终板部件固定螺钉4。以下结合附图对组成本发明的各部件进行详细描述:Referring to Fig. 1, the adjustable artificial cervical vertebra of the present invention and the intervertebral connection complex include vertebral body parts and two endplate parts 1 that are connected to the upper and lower ends of the vertebral body parts through a ball joint structure respectively; 2 and the lower vertebral body part 3, wherein the upper vertebral body part 2 and the lower vertebral body part 3 are connected axially by threads; A
参见图1、图2、图4和图5,以上所述的球关节结构包括设置在终板部件1上的关节球结构6以及设置在上椎体部件2或下椎体部件3端部与关节球结构6相适应的臼口结构10,该臼口结构10的内部空间由处于中心的圆柱空间以及与圆柱空间两侧相贯的半球空间组成;且臼口结构10的内部大、出口小,将关节球结构6包在其内。关节球结构6与臼口结构10相互配合,实现椎间连接四个自由度的活动功能。Referring to Fig. 1, Fig. 2, Fig. 4 and Fig. 5, the ball joint structure described above includes the
在本发明的最佳实施例中:关节球结构6由直径4mm的圆球的85%和与之匹配的圆柱状结构相连。该关节球结构6分别与上椎体部件和下椎体部件的臼口结构10相吻合。上下的臼口结构10在左右侧面是与关节球结构6完全吻合的(即直径为4mm)。臼口结构10是由一个直径为4mm的圆沿X轴(即水平面上沿椎体前后缘中点的连线)拉伸1.5mm构成的。立体的看,相当于是一个直径为4mm的半球加一个底面直径为4mm,高为1.5mm的圆柱形再加上一个直径为4mm的半球三部分共同组成的窝柱结构的85%。这样的椎间连接有如下优点:1、85%的匹配性可以形成超过一半的关节吻合性,保证该椎间连接的绝对稳定,不会造成置入术后的关节脱位现象的发生;2、椎间连接活动的中心偏向椎体的中柱略靠后的位置,符合正常脊柱的运动轴心,置入后对脊柱的生物力学性能影响不大;3、该椎间连接可以实现4个自由度的活动,(设定水平面上沿椎体前后缘中点的连线为X轴,水平面上沿椎体左右缘中点的连线为Y轴,垂直方向为Z轴),分别是前屈和后伸约15°(即沿Y轴旋转),左右侧屈约15°(即沿X轴旋转),左右旋转由于脊柱后柱的限制作用,也能保持在15到20°(即沿Z轴旋转),前后平移约1.5mm(即沿X轴平移)。其中最重要的是该椎间连接能够实现目前几乎所有的人工椎间盘和人工椎体都不能实现的前后平移的作用。多数文献证实,人的脊柱在能够进行前屈,后伸,左右侧屈,左右旋转的功能的同时,还能够进行上下椎体间的前后平移,该前后平移对防止椎间盘及颈椎退变有积极的作用。但是前后平移的距离不宜过大,如果过大,会造成椎体失稳。因此,通过独特设计的窝柱结构而形成的椎间连接,可以使上下椎体间有约1.5mm的前后平移作用。能够最大限度的仿生人体颈椎和抑制颈椎疾病的术后退变。In the best embodiment of the present invention: the
如图5和图6,终板部件1包括圆板9,在圆板9的内侧面边沿垂直固定关节球结构6,圆板9的外侧面在远离所述关节球结构6固定位置的边沿处通过相邻的两个螺孔7固定有两个终板部件固定螺钉4;终板部件固定螺钉4的轴向与所述圆板9平面成一定角度(如图1所示)。圆板9的板厚度于固定终板部件固定螺钉4的一侧薄、于固定关节球结构6的一侧厚。并且在圆板9的外侧面上设置有小齿结构8。As shown in Fig. 5 and Fig. 6, the end plate component 1 includes a
在本发明的最佳实施例中:In the preferred embodiment of the present invention:
终板部件1的圆板9前半部分较后半部分薄,从侧面看形成切面,角度约为10°,该切面约从圆板9的正中线开始,沿前下方向,形成一个约10°的切面。该切面使终板部件1与相邻的上椎体形成了80°的斜面,与相邻的下椎体形成了100°的斜面。这两个斜面非常有利于与施术椎体相邻的上下椎体的终板密切贴合。在圆板9的前半部分,有两个螺孔7,(螺孔位置参见图6,螺孔的方向是与相邻椎体的前缘线呈20°的夹角),这两个螺孔带内螺纹,与终板部件固定螺钉4相配合。本发明的终板部件固定螺钉4的前端为尖头,其后端为螺帽(如图1所示),该终板部件固定螺钉4的近螺帽端比其近尖头端略粗。终板部件固定螺钉4可以与施术椎体相邻的椎体成20°的角度的方向置入相邻椎体。终板部件固定螺钉4的近螺帽端与螺孔7配合,由于螺孔7的内螺纹结构,配合较长的终板部件固定螺钉4,可以将本复合体稳定的固定在施术椎体相邻的椎体上,实现即刻稳定,发挥椎体的支撑作用。同时,这样的固定方式与前方螺钉固定相比,螺钉拧入的深度更长,更符合生物力学特性。另外,本发明之所以将终板部件固定螺钉4的钉身设计为前端细,后端与螺孔7配合的一端略粗,是因为这种结构在将终板部件固定螺钉4由螺孔7穿入时,可以方便的调节终板部件固定螺钉4的角度,等终板部件固定螺钉4攻入相邻的椎体内时,其近螺帽端刚好与螺孔7进行螺纹配合,从而将终板部件固定螺钉4的角度锁定。The front half of the
圆板9的上表面为磨砂样粗糙结构,并有利用等离子体氧化技术处理而形成的生物用羟基磷灰石涂层,涂层厚度约1μm,上表面的后半部分有大小约1μm的小齿结构8。所有的上表面处理,都可以加速终板结构与相邻椎体的早期融合,有利于实现生物融合和长期稳定性。The upper surface of the
参见图1或者图2和图4,上椎体部件2的下部缩颈并设有外螺纹,下椎体部件3上端为设有内螺纹的圆筒结构,上椎体部件2的下部缩颈端通过螺纹旋入下椎体部件3的内螺纹内;在上椎体部件2和下椎体部件3的轴向均匀分布有若干径向螺纹孔11和12(图2、3中给出具有3个径向螺纹孔11、12的情况),长度固定螺钉5能够通过螺纹装入螺纹孔内以固定上椎体部件2和下椎体部件3在轴向上的相对位置。Referring to Fig. 1 or Fig. 2 and Fig. 4, the lower part of the upper vertebral body part 2 is constricted and provided with external threads, the upper end of the lower vertebral body part 3 is a cylindrical structure provided with internal threads, and the lower part of the upper vertebral body part 2 is constricted The end is screwed into the internal thread of the lower vertebral body part 3 by threads; some radial threaded
在本发明的最佳实施例中:In the preferred embodiment of the present invention:
下椎体部件3由上部(直径约12mm,高约10mm,壁厚约2mm)的空心圆柱结构和下部(直径约12mm,高约4mm)的实心圆柱部分组成(参见图4)。上部的空心圆柱结构的正前方有一个直径为2mm的固定孔,带内螺纹。左右侧面各有四个连续的融合螺孔,直径为2mm,不带螺纹。下椎体部件3的外表面覆有经过等离子体氧化技术处理的厚度约为1μm的生物用羟基磷灰石涂层。下部正中有前述的臼口结构10,下部的虚线显示了臼口结构10的位置,臼口结构10与下位终板部件1的关节球结构6相匹配。The lower vertebral body part 3 is composed of a hollow cylindrical structure at the top (about 12 mm in diameter, about 10 mm in height, and about 2 mm in wall thickness) and a solid cylindrical part at the bottom (about 12 mm in diameter, about 4 mm in height) (see FIG. 4 ). There is a fixing hole with a diameter of 2mm and an internal thread directly in front of the upper hollow cylindrical structure. There are four consecutive fusion screw holes on the left and right sides, each with a diameter of 2mm, without threads. The outer surface of the lower vertebral body part 3 is coated with biological hydroxyapatite coating with a thickness of about 1 μm treated by plasma oxidation technology. There is the
上椎体部件2的下部的外螺纹可与下椎体部件3的上部的内螺纹相吻合。由于螺距是1mm,所以每外旋转一圈可以使整个复合体的长度增加1mm。上椎体部件2的下部左右两侧各有四个融合螺孔12,下椎体部件3的上部左右两侧也各有四个融合螺孔15,融合螺孔的直径均为2mm,不带螺纹。每旋转两圈,上椎体部件2的融合螺孔(即螺孔12)就会与一部分下椎体部件3的融合螺孔(即螺孔11)相通。在长期植入后,上椎体部件2的下部空心圆柱结构内填充的碎骨可以沿着融合螺孔长出,实现稳定的椎体部件与施术椎体的稳定融合。此外,可靠上椎体部件和下椎体部件外表面的羟基磷灰石涂层,可以加速术后的融合过程,实现生物学融合,保证了长期稳定性。The external thread of the lower part of the upper vertebral body part 2 can coincide with the upper part of the internal thread of the lower vertebral body part 3 . Since the thread pitch is 1 mm, each outer turn increases the length of the entire complex by 1 mm. There are respectively four fusion screw holes 12 on the left and right sides of the bottom of the upper vertebral body part 2, and four fusion screw holes 15 are respectively arranged on the left and right sides of the upper part of the lower vertebral body part 3, and the diameter of the fusion screw holes is 2mm. thread. Every two rotations, the fusion screw hole (ie screw hole 12 ) of the upper vertebral body part 2 communicates with the fusion screw hole (ie screw hole 11 ) of a part of the lower vertebral body part 3 . After long-term implantation, the bone fragments filled in the lower hollow cylindrical structure of the upper vertebral body part 2 can grow out along the fusion screw hole, so as to realize the stable fusion of the stable vertebral body part and the operating vertebral body. In addition, the reliable hydroxyapatite coating on the outer surface of the upper and lower vertebral body parts can accelerate the postoperative fusion process, achieve biological fusion, and ensure long-term stability.
上椎体部件2下部正前方的四个调节螺孔11和下椎体部件3上部正前方的一个固定螺孔均带内螺纹,与椎体长度固定螺钉5相匹配。由于调节螺孔和固定螺孔的直径均为2mm,因此每旋转两圈,下椎体部件3的正前方的固定螺孔就会和上椎体部件2的正前方的调节螺孔相吻合,此时,可用椎体长度固定螺钉5沿固定螺孔和调节螺孔拧入,依靠上椎体部件2的下部的外螺纹与下椎体部件3的上部的内螺纹的吻合性和螺钉5与固定螺孔及调节螺孔的把持力,实现复合体长度的固定。四个调节螺孔可以保证使整个复合体的长度调节6mm,完全满足正常人颈椎的长度需要。Four adjusting screw holes 11 directly in front of the lower part of the upper vertebral body part 2 and a fixing screw hole directly in front of the upper part of the lower part of the vertebral body part 3 are all with internal threads, which match the length of the vertebral body with the fixing
以上上椎体部件2和下椎体部件3两者相互配合,通过旋转可以调节整个复合体的长度(整个复合体最小长度为23mm,最大长度为29mm。调节范围为6mm)。The above upper vertebral body part 2 and the lower vertebral body part 3 cooperate with each other, and the length of the whole complex can be adjusted by rotation (the minimum length of the whole complex is 23mm, and the maximum length is 29mm. The adjustment range is 6mm).
综上所述,本发明的可调式颈椎人工椎体及椎间连接复合体尤其适合于处理相邻两个颈椎间盘突出导致的颈椎病,可以行椎间盘摘除、椎体次全切除、本复合体置换术。同时,对于颈椎单椎体肿瘤可以行患椎次全切并本复合体置换术。此外,对于不适用于人工颈椎间盘置换的患者,人工颈椎间盘置换术后翻修,颈椎融合术后退变严重等多种颈椎疾病都可以使用本复合体。以下就椎间盘摘除、椎体次全切除并本复合体置换术来说明手术中的具体实施方式对于具备适应症,术前检查未见禁忌症的患者进行该手术治疗,常规术前准备,通常选择气管内插管全麻。体位为仰卧位,双肩垫软枕,头自然向后仰伸,后枕部垫软头圈预防压疮,头两侧各放置小沙袋以防止术中头旋转。切口一般采用颈前横切口,暴露患椎和椎间盘,定位针并术中C形臂X线光透视机定位。于拟行次全切除的椎体的上下位椎体中央分别拧入颈椎椎体撑开器螺钉,在撑开螺钉上套入撑开器,向上下两端撑开。减压:用尖刀切开施术椎体上下方的椎间盘的纤维环,髓核钳取出椎间盘组织,用三关节尖嘴咬骨钳咬除椎体的前皮质骨和大部分的松质骨,接近椎体后缘时暂停,完全切除施术椎体上下方的椎间盘,用刮匙、咬骨钳和圆头锉修复椎间关节面至软骨下出血,使终板大致平行,不可破坏骨性终板。用神经剥离器分离出椎体后缘与后纵韧带间的间隙,用枪式咬骨钳逐步咬除椎体后缘皮质骨,形成一个长方形的减压槽(有时可根据需要咬除后纵韧带),减压槽的宽度大致12mm。调节椎体撑开器撑开的高度,使颈椎前柱的高度恢复正常。此时,将次全切下的椎体骨质减成2mm左右的碎骨,填充在本复合体上椎体部件下部的圆柱形空心结构内。置入本复合体,按照所需高度调节本复合体的长度,使上终板部件与上位椎体的下终板相贴合,下终板部件与下位椎体的上终板相贴合。根据这个长度,拧入椎体长度固定螺钉5,固定本复合体长度。将本复合体的上下椎体部件击入减压槽。根据终板部件上的固定螺孔7,分别在上下位椎体的下上终板上开口,再将终板固定螺钉4按与上下位椎体前缘成20°角拧入上下位椎体。松开椎体撑开器,使本复合体嵌紧。C形臂X线光机透视无误后,冲洗伤口,防止引流,逐层缝合。术后颈托制动40天,预防性使用抗生素,密切观察,其他按颈前路手术常规处理。In summary, the adjustable cervical artificial vertebral body and intervertebral connection complex of the present invention are especially suitable for treating cervical spondylosis caused by herniation of two adjacent cervical intervertebral discs. replacement surgery. At the same time, subtotal vertebral resection and complex replacement can be performed for cervical single vertebral body tumors. In addition, for patients who are not suitable for artificial cervical disc replacement, this complex can be used for various cervical diseases such as revision after artificial cervical disc replacement and severe degeneration after cervical fusion. The following describes the specific implementation of the operation in terms of intervertebral disc removal, subtotal vertebral body resection and replacement of this complex. General anesthesia with endotracheal intubation. The body position is supine, the shoulders are padded with soft pillows, the head is naturally stretched back, the back pillow is padded with a soft headband to prevent pressure sores, and small sandbags are placed on both sides of the head to prevent head rotation during the operation. The incision is generally made through an anterior cervical transverse incision to expose the affected vertebra and intervertebral disc, and the needle is positioned using a C-arm X-ray fluoroscopy machine during the operation. Cervical vertebral body spreader screws are respectively screwed into the center of the upper and lower vertebral bodies of the vertebral body to be subjected to subtotal resection, and the spreader is inserted on the spreader screws, and the upper and lower ends are spread apart. Decompression: use a sharp knife to incise the fibrous annulus of the intervertebral disc above and below the operated vertebral body, remove the intervertebral disc tissue with a nucleus pulposus forceps, and bite off the anterior cortical bone and most of the cancellous bone of the vertebral body with a three-joint sharp-nose rongeur. Pause when approaching the posterior edge of the vertebral body, completely resect the upper and lower intervertebral discs of the operating vertebral body, and repair the intervertebral articular surface to the subchondral hemorrhage with curettes, rongeurs, and round-head files, so that the endplates are roughly parallel and the bone cannot be damaged endplate. Use a nerve stripper to separate the gap between the posterior edge of the vertebral body and the posterior longitudinal ligament, and gradually bite off the cortical bone at the posterior edge of the vertebral body with a gun-style rongeur to form a rectangular decompression groove (sometimes the posterior longitudinal ligament can be bitten off as needed). ligament), the width of the decompression groove is about 12mm. Adjust the height of the vertebral body spreader to restore the height of the cervical anterior column to normal. At this time, the subtotal excised vertebral body bone is reduced to about 2 mm bone fragments, and filled in the cylindrical hollow structure at the lower part of the upper vertebral body part of the complex. Put this complex, adjust the length of this complex according to the required height, make the upper endplate part fit the lower endplate of the upper vertebral body, and the lower endplate part fit the upper endplate of the lower vertebral body. According to this length, screw in the vertebral body
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