技术领域technical field
本发明涉及一种医疗器械，尤其是一种用于脊椎固定的棘突间撑开装置。The invention relates to a medical device, in particular to an interspinous process distraction device for spinal fixation.
背景技术Background technique
目前，在治疗脊椎病变或损伤时，一般都采用脊椎固定装置对脊椎进行固定手术，或者用人工椎体作为替代物进行手术。At present, in the treatment of spinal lesions or injuries, spinal fixation devices are generally used to fix the spine, or artificial vertebral bodies are used as substitutes for surgery.
常用的脊椎固定装置由纵向杆和椎弓根钉构成，纵向杆和椎弓根钉的连接固定对手术效果和质量会产生直接的影响。而纵向杆和椎弓根钉的连接固定都是通过旋紧螺钉的紧固方式，这种方式不仅操作不够方便，而且压紧螺钉时容易将椎弓根钉的螺钉头撑开脱出，造成手术失败。如要避免椎弓根钉螺钉头在压紧螺钉时滑脱，不仅要提高其制造材料要求，在尺寸上还必须具有一定高度，这样会增大椎弓根钉在人体内所占用的空间，影响手术质量，增加病人痛苦。Commonly used spinal fixation devices are composed of longitudinal rods and pedicle screws, and the connection and fixation of the longitudinal rods and pedicle screws will have a direct impact on the effect and quality of the operation. The connection and fixation of the longitudinal rod and the pedicle screw are all through the fastening method of tightening the screw. This method is not only inconvenient to operate, but also the screw head of the pedicle screw is easy to be stretched out when the screw is tightened, causing surgery fail. If the screw head of the pedicle screw is to be prevented from slipping when the screw is pressed, not only the requirements for its manufacturing material must be improved, but also the size must have a certain height, which will increase the space occupied by the pedicle screw in the human body and affect the operation. quality, increasing patient suffering.
人工椎体替代物的材料各异, 有异体骨、陶瓷、金属等，其中异体骨存在来源有限、免疫排斥反应等缺陷，陶瓷类在体内易碎和易被疲劳破坏，而钛合金既能提供术后即刻稳定性，又与人体的弹性模量比较接近。部分人工椎体虽然具有能恢复椎体高度的可调性，但最大的缺点是彻底去除了手术部位椎体的活动性。显然传统人工椎体在某些方面尚存在一些有待解决的问题，特别是术后椎体活动性的稳定性不够、与上下椎体早期结合强度低等，其并发症是易导致植入物移位甚至脱出、手术部位脊柱运动功能受限、邻近节段的脊柱由于代偿性地过度活动带来的一系列负荷增加、退变加速等。The materials of artificial vertebral body substitutes are different, including allogeneic bone, ceramics, metals, etc. Allogeneic bone has defects such as limited sources and immune rejection. Ceramics are fragile and easily damaged by fatigue in the body, while titanium alloys can provide both Immediately after surgery, it is stable and close to the elastic modulus of the human body. Although some artificial vertebral bodies have the adjustability that can restore the height of the vertebral body, the biggest disadvantage is that the mobility of the vertebral body at the surgical site is completely removed. Obviously, there are still some problems to be solved in some aspects of the traditional artificial vertebral body, especially the insufficient stability of the postoperative vertebral body mobility and the low early bonding strength with the upper and lower vertebral bodies. Position or even prolapse, restricted spinal motion at the surgical site, a series of load increases and accelerated degeneration of adjacent segments of the spine due to compensatory over-activity.
腰椎退行性疾病是脊柱外科的常见多发病，患病群体在逐年扩大，而且年轻化的趋势越发明显。腰椎融合术是处理腰椎间盘源性痛、节段性不稳、滑脱等疾患的主要手段，虽然内固定的应用使融合率和临床结果有很大改善，但与此相关的问题仍然不少。例如，传统的脊柱融合内固定手术可能出现邻近节段椎间盘退变加快的问题。Lumbar degenerative disease is a common and frequently-occurring disease in spinal surgery, and the population of patients is expanding year by year, and the trend of younger patients is becoming more and more obvious. Lumbar fusion is the main method to deal with lumbar discogenic pain, segmental instability, slippage and other diseases. Although the application of internal fixation has greatly improved the fusion rate and clinical results, there are still many related problems. For example, traditional spinal fusion and internal fixation surgery may have the problem of accelerated degeneration of adjacent segmental discs.
发明内容Contents of the invention
本发明所要解决的技术问题是提供一种手术创伤小、术后椎体活动性较强、稳定性好、简易安全耐用、不容易移位和脱出、使年轻患者更易于接受的棘突间撑开装置。The technical problem to be solved by the present invention is to provide an interspinous process brace with small surgical trauma, strong postoperative vertebral body mobility, good stability, simple, safe and durable, not easy to shift and fall out, and more acceptable to young patients. Turn on the device.
本发明解决上述问题所采用的技术方案是：该棘突间撑开装置由依次连接为一体结构的椎体上部、椎体中部和椎体下部组成，其结构特点是所述椎体上部和椎体下部均为U形凹槽结构，两者的U形凹槽开口方向相反；椎体中部呈S形结构，该S形的上端与椎体上部U形凹槽的底部相连接并位于同一平面上，且该S形的上端的外壁上设有多个外凸的上倒钩齿形，该S形的下端与椎体下部U形凹槽的底部相连接并位于同一平面上，且该S形的下端的外壁上设有多个外凸的下倒钩齿形，同时该S形的下端向椎体上部方向延伸并弯曲形成一弧形部；上倒钩齿形和下倒钩齿形位于同一侧；椎体上部的U形凹槽的底部开有U形通孔。The technical solution adopted by the present invention to solve the above-mentioned problems is: the interspinous process distraction device is composed of the upper part of the vertebral body, the middle part of the vertebral body and the lower part of the vertebral body connected in sequence, and its structural feature is that the upper part of the vertebral body and the lower part of the vertebral body The lower part of the body is a U-shaped groove structure, and the opening directions of the U-shaped grooves of the two are opposite; the middle part of the vertebral body is an S-shaped structure, and the upper end of the S-shaped body is connected with the bottom of the U-shaped groove in the upper part of the vertebral body and is located on the same plane , and the outer wall of the upper end of the S-shape is provided with a plurality of protruding upper barb teeth, the lower end of the S-shape is connected with the bottom of the U-shaped groove at the lower part of the vertebral body and is located on the same plane, and the S-shape The outer wall of the lower end of the S shape is provided with a plurality of protruding lower barb tooth shapes, and the lower end of the S shape extends toward the upper part of the vertebral body and bends to form an arc; the upper barb tooth shape and the lower barb tooth shape Located on the same side; the bottom of the U-shaped groove on the upper part of the vertebral body has a U-shaped through hole.
本发明所述椎体上部和椎体下部U形凹槽的侧壁的内侧和外侧均设有多个外凸的三角齿形。The inner and outer sides of the U-shaped grooves at the upper part of the vertebral body and the lower part of the vertebral body are provided with a plurality of protruding triangular teeth.
本发明所述椎体上部和椎体下部的侧壁上分别设有两个椭圆形螺钉孔。Two elliptical screw holes are respectively arranged on the side walls of the upper part of the vertebral body and the lower part of the vertebral body in the present invention.
本发明所述的椎体上部、椎体中部和椎体下部由钛合金材料制成。The upper part of the vertebral body, the middle part of the vertebral body and the lower part of the vertebral body described in the present invention are made of titanium alloy material.
本发明所述椎体上部和椎体下部U形凹槽的侧壁的内侧设有两个外凸的三角齿形，椎体上部和椎体下部U形凹槽的侧壁的外侧设有五个外凸的三角齿形。The upper part of the vertebral body and the inner side of the sidewall of the U-shaped groove at the lower part of the vertebral body according to the present invention are provided with two protruding triangular teeth, and the outer sides of the upper part of the vertebral body and the sidewall of the U-shaped groove at the lower part of the vertebral body are provided with five A convex triangular tooth shape.
本发明与现有技术相比，具有以下有益效果：1、该装置是一种在棘突之间插入的金属装置，设计目的是增加神经源性跛行患者狭窄管的横截面直径，该装置的椎体中部采用S形结构安装在棘突和翅膀之间，可以防止其在植入后移动，S形结构纵向上有弹性，可以被压缩，可以方便地被植入人体内，能够兼顾脊柱的稳定性和活动性，无需植骨融合，保存腰椎的生理活动功能的同时，也提供足够的稳定性，最大限度减少术后因腰椎不稳定导致的慢性腰痛；2、该装置采用钛合金材料，生物相容性好，无需再次手术取出，适用于影像学检查证实的中到重度压缩，神经元件受损导致跛行和/或神经根症状分离到1或2级，在L1至S1区域，伴有或不伴有下腰痛；3、该装置椎体上部和椎体下部内外侧均设有外凸的三角齿形，用于帮助该非融合椎体固定于人体中，不易移位和脱落，以获得稳定性，一旦合适的位置已经实现，夹紧器安全地卷曲该棘突间撑开装置的椎体上部和椎体下部，椎体上部和椎体下部侧壁上的三角齿形牢牢地咬住棘突的皮质；4、该装置椎体中部在靠近椎体前部和椎体后部处均设有外凸的倒钩齿形，用于有效阻止该非融合椎体在脊柱中移动；5、使用该装置可大大减少手术的创伤面，简化操作流程，术后椎体活动性的稳定性非常好，不容易移位和脱出，同时可有效改善对邻近节段负荷增加、退变加速等并发症的影响，为椎体的康复治疗提供了一种有效手段；6、该装置提高了在椎弓根部位骨融合的效率，减少了移植的失败率，防止手术部位邻近组织的退行性变化及骨的移动，具有平均分配应力的功能，减少了在手术中产生的额外的应力，同时降低了邻近组织退行性病变的几率，并允许DISC的替换，在部分的组织移动中创造了良好的环境。Compared with the prior art, the present invention has the following beneficial effects: 1. The device is a metal device inserted between the spinous processes, and the design purpose is to increase the cross-sectional diameter of the narrow tube of patients with neurogenic claudication. The middle part of the vertebral body is installed between the spinous process and the wings with an S-shaped structure, which can prevent it from moving after implantation. The S-shaped structure is elastic in the longitudinal direction and can be compressed, so it can be easily implanted in the human body and can take care of the spine. Stability and mobility, no need for bone graft fusion, while preserving the physiological function of the lumbar spine, it also provides sufficient stability to minimize postoperative chronic low back pain caused by lumbar instability; 2. The device is made of titanium alloy material, Good biocompatibility, no need for resurgical removal, suitable for moderate to severe compression confirmed by imaging studies, damage to neural components leading to claudication and/or nerve root symptoms dissociated to grade 1 or 2, in the L1 to S1 area, with Or without low back pain; 3. The upper part of the vertebral body and the inner and outer sides of the lower part of the vertebral body are provided with convex triangular teeth, which are used to help the non-fused vertebral body to be fixed in the human body, so that it is not easy to shift and fall off. Stabilization is achieved, and once the proper position has been achieved, the clamp securely crimps the superior and inferior vertebral bodies of the interspinous process distraction device, and the triangular teeth on the lateral walls of the superior and inferior vertebral bodies securely Bite the cortex of the spinous process; 4. The middle part of the vertebral body of the device is provided with protruding barb teeth near the front part of the vertebral body and the back part of the vertebral body, which are used to effectively prevent the non-fused vertebral body from moving in the spine; 5. The use of this device can greatly reduce the surgical trauma surface and simplify the operation process. The stability of postoperative vertebral body mobility is very good, and it is not easy to shift and prolapse. At the same time, it can effectively improve the load increase and degeneration acceleration of adjacent segments. 6. The device improves the efficiency of bone fusion at the pedicle, reduces the failure rate of transplantation, and prevents the degeneration of adjacent tissues at the surgical site. Changes and bone movement, with the function of evenly distributing stress, reducing the extra stress generated during the operation, while reducing the chance of adjacent tissue degeneration, and allowing the replacement of DISC, creating a good environment for partial tissue movement environment of.
附图说明Description of drawings
图1为本发明实施例的主视图。Fig. 1 is a front view of an embodiment of the present invention.
图2为本发明实施例的左视图。Fig. 2 is a left view of the embodiment of the present invention.
图3为本发明实施例的右视图。Fig. 3 is a right side view of the embodiment of the present invention.
图4为本发明实施例的俯视图。Fig. 4 is a top view of an embodiment of the present invention.
图5为本发明实施例的仰视图。Fig. 5 is a bottom view of an embodiment of the present invention.
图6为本发明实施例的立体图。Fig. 6 is a perspective view of an embodiment of the present invention.
图7为本发明实施例另一个角度的立体图。Fig. 7 is a perspective view from another angle of the embodiment of the present invention.
图8为本发明实施例的使用状态图。Fig. 8 is a diagram of the use state of the embodiment of the present invention.
具体实施方式Detailed ways
参见图1-图8，本实施例由Ti-6Al-4VELI钛合金（ASTM F136）制成，由依次连接为一体结构的椎体上部1、椎体中部2和椎体下部3组成。椎体上部1和椎体下部3均为U形凹槽结构，两者的U形凹槽开口方向相反。椎体中部2呈S形结构，该S形的上端与椎体上部1U形凹槽的底部相连接并位于同一平面上，且该S形的上端的外壁上设有五个外凸的上倒钩齿形4；该S形的下端与椎体下部3U形凹槽的底部相连接并位于同一平面上，且该S形的下端的外壁上设有两个个外凸的下倒钩齿形5，同时该S形的下端向椎体上部1方向延伸并弯曲形成一弧形部6。由于S形结构之间留有间隙，使得该非融合椎体纵向上有弹性，可以压缩，有利于非融合椎体植入人体内。上倒钩齿形4和下倒钩齿形5位于同一侧，用于有效阻止该非融合椎体在脊柱中移动。椎体上部1的U形凹槽的底部开有U形通孔9，U形通孔9的作用在于能提供预置张力负荷使椎间盘按需减压，同时其接近正常节段的瞬时旋转轴在腰椎屈伸运动中能够更加均匀地减轻椎间盘的负荷，从而提高植骨融合率、减少邻近节段的退变，并且提供动态的稳定。Referring to Fig. 1-Fig. 8, this embodiment is made of Ti-6Al-4VELI titanium alloy (ASTM F136), and consists of the upper part 1 of the vertebral body, the middle part of the vertebral body 2 and the lower part of the vertebral body 3 which are sequentially connected as an integral structure. The upper part 1 of the vertebral body and the lower part 3 of the vertebral body are both U-shaped groove structures, and the opening directions of the U-shaped grooves of the two are opposite. The middle part of the vertebral body 2 has an S-shaped structure, the upper end of the S-shaped body is connected with the bottom of the U-shaped groove of the upper part of the vertebral body and is located on the same plane, and the outer wall of the upper end of the S-shaped body is provided with five protruding upward inversions. Hook tooth shape 4; the lower end of the S shape is connected to the bottom of the 3 U-shaped groove at the lower part of the vertebral body and is located on the same plane, and the outer wall of the lower end of the S shape is provided with two protruding lower barb tooth shapes 5. At the same time, the lower end of the S-shape extends toward the upper part of the vertebral body 1 and bends to form an arc-shaped part 6 . Since there are gaps between the S-shaped structures, the non-fused vertebral bodies are longitudinally elastic and can be compressed, which is beneficial for the non-fused vertebral bodies to be implanted in the human body. The upper barb tooth shape 4 and the lower barb tooth shape 5 are located on the same side, and are used to effectively prevent the non-fused vertebral body from moving in the spine. There is a U-shaped through hole 9 at the bottom of the U-shaped groove on the upper part of the vertebral body. The function of the U-shaped through hole 9 is to provide a preset tension load to decompress the intervertebral disc as needed, and at the same time it is close to the instantaneous rotation axis of the normal segment. The load on the intervertebral disc can be more uniformly relieved during lumbar flexion and extension, thereby improving the rate of bone graft fusion, reducing degeneration of adjacent segments, and providing dynamic stability.
椎体上部1和椎体下部3 U形凹槽的侧壁的内侧设有五个外凸的三角齿形7，椎体上部1和椎体下部3 U形凹槽的侧壁的外侧设有两个外凸的三角齿形7，用于帮助该棘突间撑开装置固定于人体中，不易移位和脱落，以获得稳定性。一旦合适的位置已经实现，夹紧器安全地卷曲该棘突间撑开装置的椎体上部1和椎体下部3，椎体上部1和椎体下部3侧壁上的三角齿形7牢牢地咬住棘突的皮质。The inner side of the side wall of the upper part of the vertebral body 1 and the lower part of the vertebral body 3 U-shaped grooves is provided with five protruding triangular tooth shapes 7, and the outer side of the side walls of the upper part of the vertebral body 1 and the lower part of the vertebral body 3 U-shaped grooves is provided with The two protruding triangular tooth shapes 7 are used to help the interspinous process distraction device to be fixed in the human body, so that it is not easy to shift and fall off, so as to obtain stability. Once the proper position has been achieved, the clamp securely crimps the upper vertebral body 1 and the lower vertebral body 3 of the interspinous process distraction device, and the triangular teeth 7 on the side walls of the upper vertebral body 1 and the lower vertebral body 3 are firmly secured. Biting the cortex of the spinous process.
椎体上部1和椎体下部3的侧壁上分别设有两个椭圆形螺钉孔8，用于螺钉的固定。韧带重建时，通过椭圆螺钉孔8和棘上韧带缝合。Two oval screw holes 8 are respectively provided on the side walls of the upper vertebral body 1 and the lower vertebral body 3 for fixing the screws. When the ligament is reconstructed, it is sutured through the oval screw hole 8 and the supraspinous ligament.
| Application Number | Priority Date | Filing Date | Title |
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| CN201910699728.0ACN110403688A (en) | 2019-07-31 | 2019-07-31 | interspinous process distraction device |
| Application Number | Priority Date | Filing Date | Title |
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| CN201910699728.0ACN110403688A (en) | 2019-07-31 | 2019-07-31 | interspinous process distraction device |
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| CN110403688Atrue CN110403688A (en) | 2019-11-05 |
| Application Number | Title | Priority Date | Filing Date |
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| CN201910699728.0APendingCN110403688A (en) | 2019-07-31 | 2019-07-31 | interspinous process distraction device |
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| CN (1) | CN110403688A (en) |
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| CN103622739A (en)* | 2013-11-28 | 2014-03-12 | 浙江康慈医疗科技有限公司 | Centrum non-fusion interspinous device |
| CN211023035U (en)* | 2019-07-31 | 2020-07-17 | 浙江康慈医疗科技有限公司 | Interspinous process distraction device |
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