CN105534588B - A kind of percutaneous individuation pedicle screw navigation template of detachable bilateral type - Google Patents
A kind of percutaneous individuation pedicle screw navigation template of detachable bilateral type Download PDFInfo
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- 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
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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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
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/90—Guides therefor
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Abstract
本发明涉及医疗器械技术领域,尤其涉及一种拆卸式双侧型经皮个体化椎弓根螺钉导航模板,所述导航模板设有定位机构、横连、螺钉导管和螺钉导向孔,螺钉导向孔设于横连上,从上向下穿过横连与螺钉导管相通且包含在螺钉导管内;定位机构设有乳突定位机构和附突定位机构,乳突定位机构和附突定位机构其形态分别与术前模拟所需胸腰椎的乳突、附突突完全贴合;横连设为左横连、右横连,左横连一端设有卡块,右横连一端内设有卡槽,使用时卡块插入卡槽中使左横连和右横连形成一体;螺钉导管分别与左横连和右横连连接,且将横连和定位机构连接成一体。结构简单、操作方便、成本低,降低手术难度,缩短手术时间,尤其适合应用于微创椎弓根螺钉内固定手术。
The invention relates to the technical field of medical devices, in particular to a detachable bilateral percutaneous individualized pedicle screw navigation template, the navigation template is provided with a positioning mechanism, a horizontal connection, a screw guide tube and a screw guide hole, and the screw guide hole It is located on the horizontal connection, passes through the horizontal connection from top to bottom, communicates with the screw conduit and is included in the screw conduit; the positioning mechanism is provided with a mastoid positioning mechanism and an appendage positioning mechanism, and the shape of the mastoid positioning mechanism and the appendage positioning mechanism The mastoids and appendages of the thoracolumbar spine required for the preoperative simulation are fully fitted respectively; When in use, the clamping block is inserted into the card slot so that the left horizontal connection and the right horizontal connection are integrated; the screw conduit is respectively connected with the left horizontal connection and the right horizontal connection, and the horizontal connection and the positioning mechanism are connected into one. The structure is simple, the operation is convenient, the cost is low, the operation difficulty is reduced, and the operation time is shortened, and it is especially suitable for the minimally invasive pedicle screw internal fixation operation.
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种拆卸式双侧型经皮个体化椎弓根螺钉导航模板。The invention relates to the technical field of medical devices, in particular to a detachable bilateral percutaneous individualized pedicle screw navigation template.
背景技术Background technique
胸腰椎骨折是指由于外力造成胸腰椎骨质连续性的破坏。这是最常见的脊柱损伤。在青壮年患者中,高能量损伤是其主要致伤因素,如车祸,高处坠落伤等。老年患者由于本身存在骨质疏松,致伤因素多为低暴力损伤,如滑倒、跌倒等。胸腰椎骨折患者常合并神经功能损伤,且由于致伤因素基本为高能损伤,常合并其他脏器损伤,这为治疗带来了极大的困难和挑战。Thoracolumbar fractures refer to the destruction of the continuity of the thoracolumbar spine due to external force. This is the most common spinal injury. Among young and middle-aged patients, high-energy injuries, such as car accidents and falls from heights, are the main cause of injury. Due to the existence of osteoporosis in elderly patients, the injury factors are mostly low-violence injuries, such as slips and falls. Patients with thoracolumbar fractures are often associated with neurological impairment, and because the injury factor is basically high-energy injury, they are often associated with other organ injuries, which brings great difficulties and challenges to treatment.
胸腰椎椎体压缩性和爆裂性骨折是脊柱骨折的常见类型,经后路椎弓根内固定系统是处理此类损伤的首选措施。但因传统开放置钉手术创伤较大、组织切开的范围较广、手术中会对周围组织长时间牵拉,严重而影响患者术后功能恢复 ,所以近年来随着脊柱微创外科的发展,经皮椎弓根螺钉固定技术日益受到重视 ,其术中椎弓根螺钉进钉点和钉道方向的确定是这一技术的关键,但胸腰椎解剖结构比较复杂且变异大, 常规的经皮椎弓根手术中往往需连续透视下置钉,造成医务人员和患者辐射剂量加大,长时间会导致白血病及皮肤癌的发生,徒手的椎弓根置钉虽可减少透视,但延长了手术时间,且更难满足同一椎体双侧螺钉进钉点和方向的一致性,影响复位效果,且费用高不易普及。Thoracolumbar compression and burst fractures are common types of spinal fractures, and the posterior pedicle fixation system is the first choice for dealing with such injuries. However, due to the large trauma of traditional open and place nail surgery, the wide range of tissue incision, and the long-term stretching of surrounding tissues during the operation, which seriously affects the postoperative functional recovery of patients, so in recent years with the development of minimally invasive spinal surgery , the technique of percutaneous pedicle screw fixation has been paid more and more attention. The determination of the pedicle screw entry point and the direction of the screw track during the operation is the key to this technique. In skin pedicle surgery, it is often necessary to place screws under continuous fluoroscopy, resulting in increased radiation doses for medical staff and patients, which can lead to leukemia and skin cancer for a long time. Although freehand pedicle screws can reduce fluoroscopy, it prolongs the The operation time is longer, and it is more difficult to meet the consistency of the entry point and direction of the screws on both sides of the same vertebra, which affects the reduction effect, and the cost is high and it is not easy to popularize.
目前有一些根据胸腰椎关节突结构制作出的导板结构,能够帮助手术的顺利进行,但依然存在着需要开放手术暴露解剖部位、螺钉方向会因为体位改变而变化,操作过程中稳定性不够,不好安置,操作不方便,且术后拆除不容易等等的技术问题,不适用于经皮的脊椎微创内固定手术。At present, there are some guide plate structures made according to the structure of the thoracolumbar articular process, which can help the operation to proceed smoothly, but there are still some problems that require open surgery to expose the anatomical part, the direction of the screw will change due to the change of the body position, and the stability is not enough during the operation. Easy to place, inconvenient to operate, and difficult to dismantle after surgery, etc., are not suitable for percutaneous minimally invasive internal fixation of the spine.
发明内容Contents of the invention
为解决以上技术问题,本发明提供一种拆卸式双侧型经皮个体化椎弓根螺钉导航模板,结构简单、操作方便、成本低,便捷、高效精确定位,降低手术难度,缩短手术时间,保证手术效果;特别适合于微创术中。In order to solve the above technical problems, the present invention provides a detachable bilateral percutaneous individualized pedicle screw navigation template, which has simple structure, convenient operation, low cost, convenient, efficient and accurate positioning, reduces the difficulty of surgery, and shortens the operation time. Guaranteed surgical effect; especially suitable for minimally invasive surgery.
解决以上技术问题的本发明中的一种拆卸式双侧型经皮个体化椎弓根螺钉导航模板,包括经皮个体化椎弓根螺钉导航模板,其特征在于:所述导航模板设有定位机构、横连、螺钉导管和螺钉导向孔,螺钉导向孔设于横连上,从上向下穿过横连与螺钉导管相通且包含在螺钉导管内,螺钉导向孔与定位机构连接的部分为术前模拟椎弓根螺钉最佳进钉点,导向孔的方向与术前模拟椎弓根螺钉方向一致;A detachable bilateral percutaneous individualized pedicle screw navigation template in the present invention that solves the above technical problems, including a percutaneous individualized pedicle screw navigation template, is characterized in that: the navigation template is provided with a positioning Mechanism, horizontal connection, screw guide hole and screw guide hole. The screw guide hole is set on the horizontal connection, passes through the horizontal connection from top to bottom, communicates with the screw guide tube and is included in the screw guide tube. The part connecting the screw guide hole and the positioning mechanism is The optimal screw entry point for the simulated pedicle screw before operation, and the direction of the guide hole is consistent with the direction of the simulated pedicle screw before operation;
所述定位机构设有乳突定位机构和附突定位机构,乳突定位机构和附突定位机构相连成一体,应用于胸腰椎上,其形态分别与术前模拟所需胸腰椎的乳突、附突完全贴合;The positioning mechanism is provided with a mastoid positioning mechanism and a protruding positioning mechanism, and the mastoid positioning mechanism and the protruding positioning mechanism are connected as a whole, and are applied to the thoracolumbar spine. The appendage fits perfectly;
所述横连设为左横连、右横连,左横连一端设有卡块,右横连一端内设有卡槽,使用时卡块插入卡槽中使左横连和右横连形成一体;The horizontal connection is set as a left horizontal connection and a right horizontal connection. A block is provided at one end of the left horizontal connection, and a card slot is provided at one end of the right horizontal connection. One;
所述螺钉导管两根,分别与左横连和右横连连接,且每根螺钉导管两端分别与横连和定位机构,将横连和定位机构连接成一体。The two screw conduits are respectively connected to the left horizontal connection and the right horizontal connection, and the two ends of each screw conduit are respectively connected to the horizontal connection and the positioning mechanism to integrate the horizontal connection and the positioning mechanism.
所述卡块和卡槽相应位置上设有克氏针插入孔,使用时插入克氏针以固定左横连和右横连。Kirschner wire insertion holes are provided at the corresponding positions of the block and the slot, and the Kirschner wires are inserted to fix the left horizontal connection and the right horizontal connection during use.
所述横连上表面设有指示块,以区分左右横连导管和相应的定位机构,准确确定关节突的位置,在胸腰椎两侧的定位,节省时间,减少出错。An indicator block is provided on the upper surface of the horizontal connection to distinguish the left and right horizontal connection catheters and the corresponding positioning mechanism, accurately determine the position of the articular process, and locate on both sides of the thoracolumbar spine, saving time and reducing errors.
所述螺钉导管内直径和螺钉导向孔直径大小一致,直径为4-4.1mm。The inner diameter of the screw conduit is the same as the diameter of the screw guide hole, and the diameter is 4-4.1mm.
优化方案中所述直径为4mm。The diameter mentioned in the optimized scheme is 4mm.
所述螺钉导管直径为 8mm。The screw conduit diameter is 8mm.
所述克氏针插入孔直径为2-2.1mm。The diameter of the insertion hole of the Kirschner wire is 2-2.1mm.
进一步优化方案中所述克氏针插入孔直径为2.1mm,使刚好穿过克氏针。The diameter of the Kirschner wire insertion hole described in the further optimization scheme is 2.1 mm, so that the Kirschner wire just passes through it.
所述横连与两根螺钉导管形成向内的倾斜角度,以保证椎弓根螺钉能够内倾植入。The transverse connection forms an inward oblique angle with the two screw conduits, so as to ensure that the pedicle screws can be implanted inwardly.
因为螺钉有一个向内的倾斜角度,若做成一个整体,不容易放置的问题。本发明形成拆卸式,避免了不容易放置的问题,增加了操作上的方便性和导板的稳定性,相应增加术中的成功率。Because the screw has an inward inclination angle, if it is made into a whole, it is not easy to place it. The present invention forms a detachable type, which avoids the problem that it is not easy to place, increases the convenience in operation and the stability of the guide plate, and correspondingly increases the success rate in the operation.
本发明中定位机构用来定位胸腰椎关节突螺钉进钉点,决定螺钉进钉点的位置;导向定位孔决定螺钉进钉方向。定位机构中关节乳突定位机构卡住乳突,关节侧块定位机构辅助固定,进钉点和螺钉开口就能很好的确定下来。The positioning mechanism in the present invention is used to locate the entry point of the thoracolumbar facet screw, and determine the position of the screw entry point; the guide positioning hole determines the direction of the screw entry. In the positioning mechanism, the joint mastoid positioning mechanism clamps the mastoid, and the joint side mass positioning mechanism assists in fixing, so that the nail entry point and screw opening can be well determined.
本发明中通过导航模板的横连,可以剥离更少的软组织,便于导航模板的安放,提高准确度。横连连接双侧的螺钉导管,再通过螺钉导管连接定位机构,使其成为一个整体。每根螺钉导管都与一个螺钉导向孔相通。In the present invention, through the horizontal connection of the navigation template, less soft tissue can be stripped, which facilitates the placement of the navigation template and improves the accuracy. The screw conduits on both sides are connected horizontally, and then the positioning mechanism is connected through the screw conduits to make it a whole. Each screw conduit communicates with a screw pilot hole.
本发明在数字化设计和临床操作上,对实施人员技术要求低,有基本电脑基础知识和整形外科技能的医务人员即可实施;对患者来说,仅仅需要一次CBCT检查而不必做高辐射的螺旋CT检查;如果医疗机构拥有桌面快速成型设备即可自行设计并加工导板,免去了第三方公司的数字化设计费用和费时的模棒运输过程。整个模棒成型的过程只需3-5小时,而且成本低廉,操作便捷且精度高,极大的推进了此项技术的临床应用。In terms of digital design and clinical operation, the present invention has low technical requirements for implementers, and medical personnel with basic computer knowledge and plastic surgery skills can implement it; for patients, only one CBCT examination is needed without high-radiation spiral CT inspection; if the medical institution has desktop rapid prototyping equipment, it can design and process the guide plate by itself, eliminating the cost of digital design by third-party companies and the time-consuming transportation process of mold rods. The whole molding process of the mold stick only takes 3-5 hours, and the cost is low, the operation is convenient and the precision is high, which greatly promotes the clinical application of this technology.
手术医师无需接受特殊训练即可使用,手术中明显减少软组织的剥离(特别是突节突部分)和出血,术中可以快速、准确的安置枢椎螺钉,也提高了安全性,降低了手术成本。Surgeons can use it without special training, significantly reduce the stripping of soft tissue (especially the facet part) and bleeding during the operation, and can quickly and accurately place the axial screw during the operation, which also improves the safety and reduces the operation cost .
本发明适用于中空椎弓根螺钉的植入,尤其适用于微创手术中,且操作稳定、准确和方便操作,成本低,能够减少患者术中的辐射剂量,避免医务人员的术中辐射,保证手术效果,安装和拆卸容易。The invention is suitable for the implantation of hollow pedicle screws, especially for minimally invasive surgery, and has stable, accurate and convenient operation, low cost, can reduce the radiation dose of patients during operation, and avoid intraoperative radiation of medical personnel. Guaranteed surgical effect, easy to install and disassemble.
附图说明Description of drawings
图1为本发明中的导航模板结构示意图Fig. 1 is a schematic structural diagram of a navigation template in the present invention
图2为本发明中导航模板与胸腰椎结合的结构示意图Fig. 2 is the schematic structural diagram of the combination of the navigation template and the thoracolumbar spine in the present invention
其中,图中序号具体为:1. 定位机构,2. 螺钉导管,3. 螺钉导向孔,4. 横连,5.乳突定位机构,6. 附突定位机构,7. 胸腰椎,8. 乳突,9. 指示块, 11.卡块,12.克氏针插入孔,13.卡槽 ,14.附突Among them, the serial numbers in the figure are: 1. Positioning mechanism, 2. Screw catheter, 3. Screw guide hole, 4. Cross connection, 5. Mastoid positioning mechanism, 6. Attached process positioning mechanism, 7. Thoracolumbar spine, 8. Mastoid, 9. Indicator block, 11. Block, 12. Kirschner wire insertion hole, 13. Card slot, 14. Attached protrusion
具体实施方式detailed description
下面通过结合实施例对本发明做进一步说明,应该理解的是,这些实施例仅用于例证的目的,决不限制本发明的保护范围。The present invention will be further described below in conjunction with the examples. It should be understood that these examples are only for the purpose of illustration, and in no way limit the protection scope of the present invention.
实施例1Example 1
一种拆卸式双侧型经皮个体化椎弓根螺钉导航模板,设有定位机构、横连、螺钉导管和螺钉导向孔,螺钉导向孔设于横连上,从上向下穿过横连与螺钉导管相通且包含在螺钉导管内,螺钉导向孔与定位机构连接的部分为术前模拟椎弓根螺钉最佳进钉点,导向孔的方向与术前模拟椎弓根螺钉方向一致;A detachable bilateral percutaneous individualized pedicle screw navigation template, which is equipped with a positioning mechanism, a cross connection, a screw guide tube and a screw guide hole. The screw guide hole is set on the cross connection and passes through the cross connection from top to bottom It communicates with the screw catheter and is included in the screw catheter. The part connecting the screw guide hole and the positioning mechanism is the best screw entry point for the preoperative simulated pedicle screw, and the direction of the guide hole is consistent with the direction of the preoperative simulated pedicle screw;
定位机构设有乳突定位机构和附突定位机构,乳突定位机构和附突定位机构相连成一体,应用于胸腰椎上,其形态分别与术前模拟所需胸腰椎的乳突、附突完全贴合;The positioning mechanism is equipped with a mastoid positioning mechanism and an appendage positioning mechanism. The mastoid positioning mechanism and the appendage positioning mechanism are connected as a whole, and are applied to the thoracolumbar spine. fit perfectly;
横连设为左横连、右横连,左横连一端设有卡块,右横连一端内设有卡槽,使用时卡块插入卡槽中使左横连和右横连形成一体;The horizontal connection is set as the left horizontal connection and the right horizontal connection. One end of the left horizontal connection is provided with a card block, and one end of the right horizontal connection is provided with a card slot. When in use, the card block is inserted into the card slot to make the left and right horizontal connection integrated;
螺钉导管两根,分别与左横连和右横连连接,且每根螺钉导管两端分别与横连和定位机构,将横连和定位机构连接成一体。螺钉导管内直径和螺钉导向孔直径大小一致,直径为4.1mm,螺钉导管直径为 8mm。Two screw conduits are respectively connected with the left horizontal connection and the right horizontal connection, and the two ends of each screw conduit are respectively connected with the horizontal connection and the positioning mechanism, and the horizontal connection and the positioning mechanism are connected into one. The inner diameter of the screw conduit is the same as the diameter of the screw guide hole, the diameter is 4.1mm, and the diameter of the screw conduit is 8mm.
本发明中横连与两侧导管形成向内的倾斜角度。因此作为一个整体经皮放置困难。-本发明形成拆卸式,避免了不容易放置的问题,增加了操作上的方便性和导板的稳定性,相应增加术中的成功率。In the present invention, the transverse connection forms an inward inclined angle with the conduits on both sides. Therefore, percutaneous placement as a whole is difficult. - The present invention forms a detachable type, which avoids the problem that it is not easy to place, increases the convenience of operation and the stability of the guide plate, and correspondingly increases the success rate in the operation.
定位机构用来定位胸腰椎椎弓根螺钉进钉点,决定螺钉进钉点的位置;导向定位孔决定螺钉进钉方向。通过导航模板的横连结构,可以剥离更少的软组织,便于导航模板的安放,提高准确度。The positioning mechanism is used to locate the entry point of the thoracolumbar pedicle screw and determine the position of the screw entry point; the guide positioning hole determines the direction of the screw entry. Through the horizontal connection structure of the navigation template, less soft tissue can be stripped, which facilitates the placement of the navigation template and improves the accuracy.
实例用于微创术中,椎弓根螺钉的进钉点刚好就在乳突及附突上,因此首先是设计与关节突配准的反向模板;通过导板打入穿刺针安置导针,然后通过导针拧入空心的螺钉。The example is used in minimally invasive surgery. The entry point of the pedicle screw is just on the mastoid process and the appendage process. Therefore, the reverse template is firstly designed and registered with the articular process; The hollow screw is then screwed in through the guide wire.
实施例2Example 2
一种拆卸式双侧个体化胸腰椎关节突导航模板,设有定位机构、横连、螺钉导管和螺钉导向孔,螺钉导向孔设于横连上,从上向下穿过横连与螺钉导管相通包含在螺钉导管内,螺钉导向孔与定位机构连接的部分为术前模拟椎弓根螺钉最佳进钉点,导向孔的方向与术前模拟椎弓根螺钉方向一致;A detachable bilateral individualized thoracolumbar facet joint navigation template, equipped with a positioning mechanism, a cross connection, a screw guide hole and a screw guide hole, the screw guide hole is set on the cross connection, and passes through the cross connection and the screw guide from top to bottom It is included in the screw catheter, and the part connecting the screw guide hole and the positioning mechanism is the best screw entry point for the preoperative simulated pedicle screw, and the direction of the guide hole is consistent with the direction of the preoperative simulated pedicle screw;
定位机构用来定位枢椎椎弓根螺钉进钉点,决定螺钉进钉点的位置;导向定位孔决定螺钉进钉方向。通过导航模板的横连结构,可以剥离更少的软组织,便于导航模板的安放,提高准确度。The positioning mechanism is used to locate the screw entry point of the pedicle of the axis, and determine the position of the screw entry point; the guide positioning hole determines the direction of the screw entry. Through the horizontal connection structure of the navigation template, less soft tissue can be stripped, which facilitates the placement of the navigation template and improves the accuracy.
横连设为左横连、右横连,左横连一端设有卡块,右横连一端内设有卡槽,使用时卡块插入卡槽中使左横连和右横连形成一体;卡块和卡槽相应位置上设有克氏针插入孔,使用时插入克氏针以固定左横连和右横连。克氏针插入孔直径为2、2.2mm或2.1mm,直径为2.1mm时可刚好使2.0mm的克氏针穿过。The horizontal connection is set as the left horizontal connection and the right horizontal connection. One end of the left horizontal connection is provided with a card block, and one end of the right horizontal connection is provided with a card slot. When in use, the card block is inserted into the card slot to make the left and right horizontal connection integrated; Kirschner wire insertion holes are provided at the corresponding positions of the block and the slot, and the Kirschner wires are inserted to fix the left horizontal connection and the right horizontal connection during use. The diameter of the Kirschner wire insertion hole is 2, 2.2mm or 2.1mm. When the diameter is 2.1mm, the 2.0mm Kirschner wire can just pass through.
螺钉导管两根,分别与左横连和右横连连接,且每根螺钉导管两端分别与横连和定位机构,将横连和定位机构连接成一体。螺钉导管内直径和螺钉导向孔直径大小一致,直径为4mm,螺钉导管直径为 8mm。Two screw conduits are respectively connected with the left horizontal connection and the right horizontal connection, and the two ends of each screw conduit are respectively connected with the horizontal connection and the positioning mechanism, and the horizontal connection and the positioning mechanism are connected into one. The inner diameter of the screw conduit is the same as the diameter of the screw guide hole, the diameter is 4mm, and the diameter of the screw conduit is 8mm.
横连上表面还设有指示块,以区分左右横连导管和相应的定位机构,准确确定胸腰椎乳突、附突的位置,节省时间,减少出错。There is also an indicator block on the upper surface of the cross-connection to distinguish the left and right cross-connection catheters and the corresponding positioning mechanisms, and accurately determine the positions of the thoracolumbar mastoids and appendages, saving time and reducing errors.
试验一test one
实验对像:Experiment object:
设采用传统透视下徒手置钉和本发明中经皮个体化导航模板引导下置钉的两组病例,其中传统透视组:男19例,女13例;年龄27~56岁,平均37.5岁。损伤原因:交通事故伤20例,高处坠落伤8 例,砸伤4例。损伤节段:T11 2例,T128例,L113例,L2 9例。There were two groups of patients who used traditional fluoroscopy to place nails by hand and the present invention guided by the percutaneous individualized navigation template. The traditional fluoroscopy group included 19 males and 13 females, aged 27 to 56 years, with an average of 37.5 years old. Causes of injury: traffic accidents in 20 cases, falls from heights in 8 cases, and crush injuries in 4 cases. Injured segments: 2 cases of T 11 , 8 cases of T 12 , 13 cases of L 1 , 9 cases of L 2 .
本发明中经皮导板组:男18例,女12例;年龄25~57岁,平均37.1岁。损伤原因:交通事故伤19例,高处坠落伤7例,砸伤4例。损伤节段:T11 2例,T128例,L112例,L2 8例。The percutaneous guide group in the present invention: 18 males and 12 females; aged 25-57 years old, with an average of 37.1 years old. Causes of injury: traffic accidents in 19 cases, falls from heights in 7 cases, and crush injuries in 4 cases. Injured segments: T 11 in 2 cases, T 12 in 8 cases, L 1 in 12 cases, L 2 in 8 cases.
两组患者性别、年龄、损伤原因、损伤节段等一般资料比较差异均无统计学意义(P>0.05),具有可比性。There was no significant difference in general data such as gender, age, injury cause, and injury segment between the two groups (P>0.05), and they were comparable.
术后观察Postoperative observation
术后24小时内应用抗生素1次。术后5d内X线片及CT检查,鼓励腰背肌功能锻炼,术后2周在支具保护下下地活动。支具使用3个月,术后10~12月取出内固定。定期复查X线片,连续随访12月以上。Antibiotics were applied once within 24 hours after surgery. X-ray films and CT examinations were performed within 5 days after the operation, and the exercise of the lumbar and back muscles was encouraged, and activities were carried out under the protection of the brace within 2 weeks after the operation. The brace was used for 3 months, and the internal fixation was removed 10 to 12 months after the operation. Regular review of X-ray films, continuous follow-up for more than 12 months.
评估指标Evaluation Index
A、临床指标:术中出血量、手术时间、术中透视次数、切口总长度、术后7天、1月疼痛视觉模拟评分。A. Clinical indicators: intraoperative blood loss, operation time, intraoperative fluoroscopy times, total incision length, visual analogue scale for pain at 7 days and 1 month after operation.
B、影像学指标:将CT资料导入Mimics软件中,测量以下指标:①椎体前缘高度百分比:椎体前缘高度÷[(上位椎体前缘高度+下位椎体前缘高度)÷2]×100%;②固定节段矢状曲度:固定节段上下位椎体上终板垂线的夹角;固定节段矢状曲度矫正度数:术后固定节段矢状曲度-术前固定节段矢状曲度;③椎弓根皮质与螺钉的关系:按3级分类,CT水平位评估,椎弓根钉完整在椎弓根内为Ⅰ级、优;突破皮质≤2 mm为Ⅱ级、可;>2 mm为Ⅲ级、差。I、Ⅱ级表示置钉成功。④术中首次植钉成功率:首次穿刺椎弓根透视进钉点位置正常,并且术后通过CT验证螺钉置钉成功(不包括首次穿刺失败而再次调整成功)。⑤矢状面螺钉植入角:CT矢状位上测量椎弓根螺钉轴线和椎体上缘的角度,两线相交位于椎体前方读数为正,后方读数为负。⑥螺钉矢状面夹角:同一椎体双侧椎弓根螺钉矢状面植入角的差值。⑦螺钉进钉点水平位置差值:CT矢状位上测量同一椎体双侧椎弓根螺钉进钉点中心与上终板水平的垂直距离差值。⑧螺钉内倾角差值:CT水平位上测量同一椎体双侧椎弓根螺钉与椎体正中平面夹角的差值。B. Imaging indicators: import the CT data into Mimics software, and measure the following indicators: ①The percentage of the anterior edge height of the vertebral body: the anterior edge height of the vertebral body÷[(the anterior edge height of the upper vertebral body+the anterior edge height of the lower vertebral body)÷2 ]×100%; ②Sagittal curvature of the fixed segment: the angle between the vertical line of the upper and lower vertebral upper endplates of the fixed segment; correction degree of the sagittal curvature of the fixed segment: postoperative sagittal curvature of the fixed segment - preoperative sagittal curvature of the fixed segment ③Relationship between pedicle cortex and screw: according to 3-level classification, CT horizontal evaluation, pedicle screw intact in the pedicle is grade I, excellent; breakthrough of cortex ≤ 2 mm is grade II, acceptable; > 2 mm is grade III, poor. Grades I and II indicate successful nail placement. ④The success rate of the first screw implantation during the operation: the position of the pedicle fluoroscopy screw insertion point for the first puncture was normal, and the success of the screw implantation was verified by CT after the operation (excluding the successful readjustment after the first puncture failed). ⑤Sagittal plane screw implantation angle: Measure the angle between the pedicle screw axis and the upper edge of the vertebral body on the sagittal CT plane. The intersection of the two lines at the front of the vertebral body is positive, and the rear reading is negative. ⑥Screw sagittal plane angle: the difference between the sagittal plane implantation angles of bilateral pedicle screws in the same vertebral body. ⑦The difference in the horizontal position of the screw entry point: the vertical distance difference between the center of the screw entry point and the level of the upper endplate of the bilateral pedicle screw of the same vertebra was measured on the sagittal CT. ⑧Screw inclination difference: Measure the difference between the bilateral pedicle screws of the same vertebra and the median plane of the vertebra at the CT level.
C、统计学方法C. Statistical methods
采用SPSS19.0统计软件进行分析。计量数据以均数±标准差表示,组内各时间点间比较采用单因素方差分析,两两比较采用配对t检验,组间比较采用独立样本t检验;计数资料以率表示,组间比较采用χ2检验;等级资料组间比较采用用秩和检验;检验水准α=0.05。SPSS 19.0 statistical software was used for analysis. The measurement data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison between each time point within a group, paired t -test was used for pairwise comparison, and independent sample t -test was used for comparison between groups. χ 2 test; rank sum test was used for comparison between groups of graded data; test level α=0.05.
结果分析:Result analysis:
所有患者均顺利完成手术,共植入椎弓根螺钉372枚。其中传统透视组和经皮导板组各有1例出现浅部感染,经伤口换药、抗生素治疗后愈合。无重要血管及神经损伤。末次随访未见内固定松动或者断裂的患者。两组患者均获随访,随访时间12~24个月,平均13.6个月。All patients successfully completed the operation, and a total of 372 pedicle screws were implanted. Among them, 1 case of superficial infection occurred in the traditional fluoroscopy group and 1 case in the percutaneous guide group, and healed after wound dressing change and antibiotic treatment. No important blood vessel and nerve injury. No internal fixation loosening or rupture was found at the last follow-up. Both groups were followed up for 12 to 24 months, with an average of 13.6 months.
两组术中出血量、手术时间差异有统计学意义(P<0.05),见表1。经皮导板组手术时医务人员因躲避至手术室门外,以铅板保护,故透视放射剂量可忽略不计。因此医务人员及患者的透射计量,两组均有统计学意义(P<0.05),经皮导板组明显低于传统透视组。两组切口长度、术前、术后7天及术后1月的VAS评分,两组差异无统计学意义(P>0.05),见表1。There were statistically significant differences in intraoperative blood loss and operation time between the two groups ( P<0.05 ), see Table 1. During the operation of the percutaneous guide group, the medical staff avoided the door of the operating room and were protected by lead plates, so the radiation dose of fluoroscopy was negligible. Therefore, the transmission measurements of medical staff and patients were statistically significant in both groups ( P<0.05 ), and the percutaneous guide group was significantly lower than the traditional fluoroscopy group. There was no significant difference between the two groups in incision length, VAS score before operation, 7 days after operation and 1 month after operation ( P>0.05 ), see Table 1.
表1 两组患者各临床指标比较(x±s)Table 1 Comparison of clinical indicators between the two groups of patients (x±s)
影像学结果Imaging results
两组术后椎体前缘高度、固定节段矢状曲度矫正度数均较术前明显改善,差异有统计学意义(P<0.05),见表2。经皮导板组螺钉首次植钉准确数、最终植钉准确数及矢状面螺钉植入角均优于传统透视组,两组差异均有统计学意义(P<0.05),见表3。经皮导板组双侧螺钉矢状面夹角、螺钉进钉点水平位置差值、螺钉内倾角差值均小于传统透视组,比较差异有统计学意义(P<0.05),经皮导板组双侧螺钉有更好的一致性,见表4。The height of the anterior edge of the vertebral body and the degree of correction of the sagittal curvature of the fixed segment in the two groups after operation were significantly improved compared with those before operation, and the difference was statistically significant ( P<0.05 ), see Table 2. The accurate number of first screw implantation, final screw implantation accuracy, and sagittal plane screw implantation angle in the percutaneous guide group were better than those in the traditional fluoroscopy group, and the differences between the two groups were statistically significant ( P< 0.05), as shown in Table 3. The angle between the sagittal plane of the bilateral screws, the difference in the horizontal position of the screw entry point, and the difference in the inclination angle of the screws in the percutaneous guide group were all smaller than those in the traditional fluoroscopy group, and the difference was statistically significant ( P< 0.05). Side screws have better consistency, see Table 4.
表2 两组患者术前后各影像学指标比较(x±s)Table 2 Comparison of imaging indicators before and after operation between the two groups (x±s)
(注:*与术前比较P<0.05,#与对照组比较P<0.05 )(Note: * P<0.05 compared with preoperative, #P <0.05 compared with control group)
表3 两组螺钉植入情况比较Table 3 Comparison of screw implantation in the two groups
表4 两组双侧螺钉一致性比较(x±s)Table 4 Consistency comparison of bilateral screws between the two groups (x±s)
从以上表中可以得出,本发明经皮导板辅助的椎弓根螺钉技术既吸取了数字骨科精准手术的特点,又兼有微创技术,通过本研究获得了手术切口小、出血少、装配简单、置钉准确、放射暴露少、复位效果好等优点,减少了医院的一次性投入,临床值得推广应用。It can be concluded from the above table that the pedicle screw technology assisted by the percutaneous guide plate of the present invention not only absorbs the characteristics of digital orthopedic precision surgery, but also has minimally invasive technology. Simple, accurate nail placement, less radiation exposure, good reset effect and other advantages, reducing the one-time investment of the hospital, it is worthy of popularization and application in clinical practice.
本发明其优点具体主要有以下几个方面:①导板容易经皮准确放置:3D打印是快速制造技术的一种形式,通过术前在计算机中设计最佳的椎弓根螺钉进钉点及方向,然后制作出有限暴露的定位导航模板辅助手术,设计的难点是确定合理可靠的导板配准点。本组患者设计的导板范围为T10~L3节段,这些椎体后方具有明显的乳突、副乳突、横突等解剖结构且位置相对较浅,导板不仅可以经皮放置,而且还可以做到有效的卡位配准。在我们的实际操作中,术者术前了解患者个性化的解剖结构并参与导板设计,术中就可以有的放矢的显露需要卡位解剖结构,使导板能有效贴敷于骨性标志上。在本研究中经皮导板组首次置钉成功率为92.2%,明显优于传统透视组(P<0.05),说明导板的经皮放置准确率高。另外,在本研究中,每个椎体的导板基座被分为左右侧两部分,这样做的目的是为了便于导板的经皮放置和取出,术者在术中适当暴露椎体后方结构后,通过放置特制拉钩,导板就较容易单侧经皮旋转安置并且卡位在骨性结构中,然后术者可以通过左右侧导板设计的“凹凸”结构将两侧连为一体,不仅增强其稳定性,也便于控制螺钉的内倾方向,同时这样的设计也便于插入定位导针后导板的取出,节省手术时间,本发明中经皮导板组的手术时间为71.6±11.9min,出血量为79.7±25.1ml,明显优于传统透视组,说明经皮导板容易放置和取出,节约了手术时间、减少了出血;The advantages of the present invention mainly include the following aspects: ① guide plate is easy to place accurately percutaneously: 3D printing is a form of rapid manufacturing technology, and the best pedicle screw entry point and direction can be designed in the computer before operation , and then make a positioning navigation template with limited exposure to assist surgery. The difficulty in the design is to determine a reasonable and reliable guide plate registration point. The range of the guide plate designed for this group of patients is from T10 to L3 segment. There are obvious anatomical structures such as mastoid process, accessory mastoid process, and transverse process behind these vertebral bodies, and the positions are relatively shallow. The guide plate can not only be placed percutaneously, but also Effective card position registration can be achieved. In our actual operation, the surgeon understands the individualized anatomical structure of the patient and participates in the design of the guide plate before the operation. During the operation, the anatomical structure that needs to be locked can be exposed in a targeted manner, so that the guide plate can be effectively applied to the bony landmarks. In this study, the success rate of first-time nail placement in the percutaneous guide group was 92.2%, which was significantly better than that in the traditional fluoroscopy group (P<0.05), indicating that the accuracy of percutaneous placement of the guide plate was high. In addition, in this study, the base of the guide plate of each vertebral body was divided into two parts, the left and right sides. The purpose of this is to facilitate the percutaneous placement and removal of the guide plate. , by placing a special retractor, the guide plate can be easily rotated on one side and positioned in the bony structure, and then the operator can connect the two sides together through the "concave-convex" structure designed on the left and right guide plates, which not only enhances its stability It is also convenient to control the inclination direction of the screw. At the same time, this design is also convenient to take out the guide plate after inserting the positioning guide pin, saving operation time. The operation time of the percutaneous guide plate group in the present invention is 71.6±11.9min, and the blood loss is 79.7± 25.1ml, significantly better than the traditional fluoroscopy group, indicating that the percutaneous guide plate is easy to place and take out, saving operation time and reducing bleeding;
②导板的经皮放置可以做到微创:导板的配准点(与骨性结构接触的面积)控制在直径16mm左右,与微创螺钉外套筒的直径相当,可以在不增大切口长度的情况下放置导板减少软组织的损伤,经皮导板组的切口长度为12.0±2.0cm、术后7天及1月疼痛VAS评分分别为5.5±0.9和1.7±0.9,与传统透视组比较无显著差异,证明其在微创方面与传统透视组一样。②The percutaneous placement of the guide plate can be minimally invasive: the registration point of the guide plate (the area in contact with the bony structure) is controlled at a diameter of about 16mm, which is equivalent to the diameter of the outer sleeve of the minimally invasive screw, and can be achieved without increasing the length of the incision. The guide plate was placed under normal circumstances to reduce soft tissue damage. The incision length of the percutaneous guide plate group was 12.0±2.0cm, and the pain VAS scores at 7 days and 1 month after operation were 5.5±0.9 and 1.7±0.9, respectively, which were not significantly different from those in the traditional fluoroscopy group. , proving that it is as minimally invasive as the traditional fluoroscopy group.
③导板可以保证螺钉排列一致和左右侧对称:在经皮导板组中导板是依据医师术前规划而完成的,这样就可保证螺钉进钉点在同侧排列一致,便于连接棒的放置;定位导板的术前规划也保证了同一椎体双侧椎弓根螺钉左右侧对称[经皮导板组的螺钉进钉点水平位置差值、螺钉内倾角差值较传统透视组明显减小(P<0.05),提高了矢状曲度Cobb角度和椎体高度的恢复[经皮导板组的椎体前缘高度比值和固定节段矢状曲度矫正度数均较对传统透视组明显更具有优势(P<0.05)。③ The guide plate can ensure the consistent arrangement of the screws and the symmetry of the left and right sides: in the percutaneous guide plate group, the guide plate is completed according to the doctor’s preoperative plan, so that the screw entry points can be arranged consistently on the same side, which is convenient for the placement of the connecting rod; positioning The preoperative planning of the guide plate also ensured the left and right symmetry of the bilateral pedicle screws of the same vertebra [the difference in the horizontal position of the screw entry point and the difference in the inclination angle of the screw in the percutaneous guide group were significantly smaller than those in the traditional fluoroscopy group ( P< 0.05), improved the recovery of sagittal curvature Cobb angle and vertebral body height [the ratio of the anterior edge height of the vertebral body and the degree of correction of the fixed segment sagittal curvature in the percutaneous guide group were significantly more advantageous than those in the traditional fluoroscopy group (P< 0.05).
⑤经皮导板减少医务人员和患者的放射暴露:目前微创螺钉应用的最大障碍之一是术中需要多次透视,加大了医务人员和患者的放射暴露,本研究中经皮导板组可以一次性较为准确的置入6枚穿刺针并同时插入导针,即减少了手术时间也降低了透视次数,医务人员术中完全可以躲避至手术室门外,以铅板保护,避免了放射暴露。⑤ Percutaneous guide reduces the radiation exposure of medical staff and patients: One of the biggest obstacles in the application of minimally invasive screws is that multiple perspectives are required during the operation, which increases the radiation exposure of medical staff and patients. In this study, the percutaneous guide group can 6 puncture needles are inserted more accurately at one time and the guide needle is inserted at the same time, which not only reduces the operation time but also reduces the number of fluoroscopy. .
⑥具有较好的可推广性:数字医学可以实现手术的精准操作,它也是现代外科手术的发展方向之一。本研究设计的导板看似构造相对复杂,但对于逆向工程软件设计来说,设计用时并不长,能够满足临床手术要求,具有推广性。本组患者从入院提取数据到导板打印可以在8h内完成。对于没有3D打印机和导板设计能力的基层医院也可通过互联网路,上传原始数据,外包设计导板及3D实物打印,然后通过物流快递送达。随着3D打印的日益普及,目前导板的打印成本并不高,对患者的经济负担影响不大,反而应用导板可以为手术医生提供更多的安全保障,提高其技术水平,减少患者并发症,使患者受益。⑥Good scalability: digital medicine can realize precise operation of surgery, and it is also one of the development directions of modern surgery. The structure of the guide plate designed in this study seems to be relatively complicated, but for the design of reverse engineering software, the design time is not long, it can meet the requirements of clinical surgery, and it has generalizability. This group of patients can be completed within 8 hours from admission data extraction to guide printing. For grass-roots hospitals without 3D printers and guide design capabilities, they can also upload original data through the Internet, outsource design guides and 3D physical printing, and then deliver them through logistics and express delivery. With the increasing popularity of 3D printing, the cost of printing guide plates is not high at present, and has little impact on the economic burden of patients. On the contrary, the use of guide plates can provide more safety guarantees for surgeons, improve their technical level, and reduce complications of patients. benefit patients.
以上所述仅为本发明的优选实施例,对本发明而言仅是说明性的,而非限制性的;本领域普通技术人员理解,在本发明权利要求所限定的精神和范围内可对其进行许多改变,修改,甚至等效变更,但都将落入本发明的保护范围内。The above description is only a preferred embodiment of the present invention, and it is only illustrative of the present invention, rather than restrictive; those of ordinary skill in the art understand that it can be used within the spirit and scope defined by the claims of the present invention. Many changes, modifications, and even equivalent changes can be made, but all will fall within the protection scope of the present invention.
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