技术领域technical field
本发明属于医疗器械技术领域，尤其涉及一种透视辅助的皮外个体化微创椎弓根螺钉导航模板。The invention belongs to the technical field of medical devices, and in particular relates to a perspective-assisted extracutaneous individualized minimally invasive pedicle screw navigation template.
背景技术Background technique
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。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，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，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，徒手有限触摸的椎弓根置钉方法虽可减少透视，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。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. Due to the large trauma of traditional open nail placement surgery, the wide range of tissue incision, and the long-term stretching of surrounding tissues during the operation, which affects the postoperative functional recovery of patients, so in recent years, with the development of minimally invasive spinal surgery, through Skin pedicle screw fixation technology has been paid more and more attention. The determination of pedicle screw entry point and screw path direction during operation is the key to this technology. Pedicle screw placement under continuous fluoroscopy is often required in root surgery, resulting in increased radiation doses for medical staff and patients, which can lead to leukemia and skin cancer for a long time. Although the method of pedicle screw placement with bare hands and limited touch can reduce fluoroscopy, it prolongs time. 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.
另外目前已经存在的皮外个体化模板，是以皮肤外部的形态为模板个体化设计，但皮肤软组织活动大，受体位等影响，且不容易固定，明显影响定位的准确性。In addition, the existing individualized templates outside the skin are individually designed based on the external shape of the skin, but the soft tissue of the skin moves a lot and is affected by the receptor position, and is not easy to fix, which obviously affects the accuracy of positioning.
发明内容Contents of the invention
为了解决上述技术问题，本发明提供一种透视辅助的皮外个体化微创椎弓根螺钉导航模板，使脊柱微创手术中经皮椎弓根螺钉植入准确，同时减少患者和医护人员的辐射。In order to solve the above-mentioned technical problems, the present invention provides a perspective-assisted extracutaneous individualized minimally invasive pedicle screw navigation template, which enables accurate implantation of percutaneous pedicle screws in minimally invasive spinal surgery, and at the same time reduces the burden on patients and medical staff. radiation.
解决以上技术问题的本发明中的一种透视辅助的皮外个体化微创椎弓根螺钉导航模板，其特征在于：所述模板具有透视辅助的引导微创椎弓根螺钉导针进入的个体化导向孔、中部弯折形成一个凹形，且用于模板固定于皮外。A fluoroscopy-assisted extracutaneous individualized minimally invasive pedicle screw navigation template in the present invention that solves the above technical problems is characterized in that: the template has a perspective-assisted individual that guides the entry of the minimally invasive pedicle screw guide needle The guide hole is formed, the middle part is bent to form a concave shape, and the template is fixed on the outside of the skin.
所述模板两侧为横连结构，标示和定位；模板中部为导航固定及连接结构，模板两侧通过模板斜部结构相连接；The two sides of the template are horizontal connection structures for marking and positioning; the middle part of the template is a navigation fixation and connection structure, and the two sides of the template are connected by template oblique structures;
所述个体化导向孔包括透视下标示棘突定位孔、透视下标示椎弓根投影中心定位孔、透视下标示椎体上缘克氏针定位孔和透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔，透视下标示椎弓根投影中心定位孔用以穿过透视下标示椎弓根投影中心定位针，透视下标示椎体上缘克氏针定位孔用以穿过透视下标示椎体上缘定位针，透视下标示棘突定位孔用以穿过透视下标示棘突定位针。The individualized guide hole includes a spinous process positioning hole under fluoroscopy, a pedicle projection center positioning hole under fluoroscopy, a Kirschner wire positioning hole on the upper edge of the vertebral body under fluoroscopy, and a pedicle hollow that can be adjusted appropriately under fluoroscopy. Guide hole for screw positioning needle, pedicle projection center positioning hole marked under fluoroscopy, used to pass through the pedicle projection center positioning needle marked under fluoroscopy, and Kirschner wire positioning hole marked under fluoroscopy on the upper edge of the vertebral body to pass through the fluoroscopy marked The positioning pin on the upper edge of the vertebral body, the spinous process positioning hole marked under fluoroscopy is used to pass through the spinous process positioning pin marked under fluoroscopy.
本发明中这些孔的设置辅助透视的定位孔，中间棘突上的孔是固定的模板作用。In the present invention, these holes are set as positioning holes for auxiliary perspective, and the holes on the middle spinous process are fixed templates.
所述透视下标示椎弓根投影中心定位孔为2个，对称位于透视下标示棘突导航孔两侧，透视下标示椎体上缘克氏针定位孔为水平两侧贯通，分别设于左横连侧部和右横连侧部。There are two pedicle projection center positioning holes marked under fluoroscopy, symmetrically located on both sides of the spinous process navigation hole marked under fluoroscopy, and the Kirschner wire positioning holes marked on the upper edge of the vertebral body under fluoroscopy are horizontally penetrated on both sides, respectively located on the left and right sides. Horizontal side and right horizontal side.
所述透视下标示棘突定位孔位于模板中部底部，孔开口一端设于模板中部上侧面，一端设于模板中部下侧面；透视下标示椎弓根投影中心定位孔位于模板斜部结构处，孔开口一端设于模板斜部上侧面，另一端设于模板中部下侧面；透视下标示椎体上缘克氏针定位孔开口一端设于模板斜部上侧面且靠近顶端处，另一端水平设于横连端侧面；透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔位于导航固定及连接结构与横连结构的连接处，以个体化的内倾角度斜穿过模板上表面和模板下表面。The spinous process positioning hole marked under the perspective is located at the bottom of the middle part of the template, one end of the opening of the hole is set on the upper side of the middle part of the template, and the other end is set on the lower side of the middle part of the template; One end of the opening is set on the upper side of the inclined part of the template, and the other end is set on the lower side of the middle part of the template; one end of the opening of the Kirschner wire positioning hole on the upper edge of the vertebral body marked under perspective is set on the upper side of the inclined part of the template and near the top, and the other end is horizontally set on the The side of the transverse connection end; the pedicle hollow screw positioning pin guide hole that can be adjusted appropriately under the aid of perspective is located at the connection between the navigation fixation and the connection structure and the transverse connection structure, obliquely passing through the upper surface of the template and the lower part of the template at an individual inclination angle surface.
所述导航固定及连接结构底部设有固定棘突定位孔，垂直穿过导航固定及连接结构上表面和导航固定及连接结构下表面，用以加强定位固定，不参与透视定位。The bottom of the navigation fixation and connection structure is provided with a fixation spinous process positioning hole, which vertically passes through the upper surface of the navigation fixation and connection structure and the lower surface of the navigation fixation and connection structure to strengthen positioning and fixation, and does not participate in perspective positioning.
所述固定棘突定位孔个数1-3个。The number of positioning holes for the fixed spinous process is 1-3.
所述透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔个数>＝2个。The number of pedicle hollow screw positioning needle guide holes that can be adjusted appropriately under the fluoroscopy assistance is >=2.
所述横连结构上表面设有指示块。An indicator block is provided on the upper surface of the horizontal connection structure.
所述模板厚14-16mm。The template is 14-16mm thick.
所述透视下标示棘突定位孔、透视下标示椎弓根投影中心定位孔、透视下标示椎体上缘克氏针定位孔和透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔的孔径为2.1mm，刚好能穿过2mm直径克氏针。The spinous process positioning hole is marked under the fluoroscopy, the pedicle projection center positioning hole is marked under the fluoroscopy, the Kirschner wire positioning hole on the upper edge of the vertebral body is marked under the fluoroscopy, and the pedicle hollow screw positioning needle guide hole that can be adjusted appropriately under the fluoroscopy The hole diameter is 2.1mm, just enough to pass through a 2mm diameter Kirschner wire.
本发明中模板边缘还可钝化处理，以避免压伤皮肤。In the present invention, the edge of the template can also be passivated to avoid crushing the skin.
本发明中结合透视辅助的个体化皮外模板，通过术中透视辅助定位，解决了模板随皮肤移动变化的问题，另外也增加了固定于棘突的定位针，防止移动。In the present invention, combined with the individualized extracutaneous template assisted by fluoroscopy, the problem that the template changes with the movement of the skin is solved by intraoperative fluoroscopy-assisted positioning, and a positioning pin fixed on the spinous process is also added to prevent movement.
本发明中的模板使经皮准确放置及容易固定，且模板完全设置在皮外，术中时不需要切口放置，另外设计棘突定位针加强定位效果。The template in the present invention enables accurate percutaneous placement and easy fixation, and the template is completely placed outside the skin, no incision is required during the operation, and spinous process positioning pins are designed to enhance the positioning effect.
本发明中的模板完全放置于体外，通过透视辅助提高其准确性，模板可以通过克氏针连接为一整体提高其稳定性，也可以在矢状位上适当的进行调整，适合不同的体位；同时减少医务人员和患者的放射暴露，床上也较小，具有较好的可推广性。The template in the present invention is completely placed outside the body, and its accuracy is improved through fluoroscopy. The template can be connected as a whole by Kirschner wires to improve its stability, and can also be properly adjusted in the sagittal position to suit different body positions; At the same time, the radiation exposure of medical staff and patients is reduced, and the bed is also smaller, which has better scalability.
本发明中导航模板适合于需要个体化的穿刺椎弓根根，单个手术椎体，比如pvp或pkp手术，尤其适用于老年人。The navigation template in the present invention is suitable for needing individualized pedicle puncture, single surgical vertebral body, such as pvp or pkp surgery, especially for the elderly.
附图说明Description of drawings
图1-2为本发明中导航模板的立体结构图Fig. 1-2 is the three-dimensional structural diagram of navigation template in the present invention
图3为本发明中导航模板与克氏针的结合示意图Fig. 3 is the combination schematic diagram of navigation template and Kirschner wire in the present invention
图4为本发明中导航模板与胸腰椎骨的结合示意图Fig. 4 is the combined schematic diagram of navigation template and thoracolumbar vertebra in the present invention
其中图中的具体标识如下:1.透视下标示椎弓根投影中心定位孔，2.透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔,3.透视下标示棘突定位孔,4.透视下标示椎体上缘克氏针定位孔，5.固定棘突定位孔，6.指示块,7.横连结构(左横连7-1,右横连7-2),8.模板边缘,9.透视下标示椎弓根投影中心定位针，10.透视下标示棘突定位针,11.透视下标示椎体上缘定位针,12.导航固定及连接结构,13.模板斜部结构(模板斜部上侧面13-1),14.模板中部底部(模板中部上侧面14-1,模板中部下侧面14-2),15.模板上表面,16.模板下表面，17.胸腰椎骨，18.进钉管，19.横连端侧面The specific markings in the figure are as follows: 1. Under fluoroscopy, mark the center positioning hole of the pedicle projection; 2. Under the fluoroscopy, the pedicle hollow screw positioning pin guide hole can be adjusted appropriately; 3. Under the fluoroscopy, mark the spinous process positioning hole. 4. Under fluoroscopy, mark the Kirschner wire positioning hole on the upper edge of the vertebral body, 5. Fix the spinous process positioning hole, 6. Indicator block, 7. Horizontal connection structure (left horizontal connection 7-1, right horizontal connection 7-2), 8 .Template edge, 9. Mark the pedicle projection center positioning pin under fluoroscopy, 10. Mark the spinous process positioning pin under fluoroscopy, 11. Mark the upper edge positioning pin of the vertebral body under fluoroscopy, 12. Navigation fixation and connection structure, 13. Template Inclined part structure (13-1 on the upper side of the inclined part of the template), 14. the bottom of the middle part of the template (14-1 on the upper side of the middle part of the template, 14-2 on the lower side of the middle part of the template), 15. the upper surface of the template, 16. the lower surface of the template, 17 .Thoracolumbar vertebrae, 18. Insertion tube, 19. Lateral side of the transverse connection end
具体实施方式detailed description
以下用具体实施例对本发明作进一步的说明：The present invention will be further described with specific examples below:
实施例1Example 1
透视辅助的皮外个体化微创椎弓根螺钉导航模板，具有透视辅助的引导微创椎弓根螺钉导针进入的个体化导向孔、中部弯折形成一个凹形，且用于模板固定于皮外。The fluoroscopy-assisted extracutaneous individualized minimally invasive pedicle screw navigation template has a fluoroscopy-assisted individualized guide hole for guiding the minimally invasive pedicle screw guide needle to enter, and the middle part is bent to form a concave shape, and is used for fixing the template on the outside the skin.
模板两侧为横连结构，标示和定位；模板中部为导航固定及连接结构，模板两侧通过模板斜部结构相连接。其中，个体化导向孔包括透视下标示棘突定位孔、透视下标示椎弓根投影中心定位孔、透视下标示椎体上缘克氏针定位孔和透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔，透视下标示椎弓根投影中心定位孔用以穿过透视下标示椎弓根投影中心定位针，透视下标示椎体上缘克氏针定位孔用以穿过透视下标示椎体上缘定位针，透视下标示棘突定位孔用以穿过透视下标示棘突定位针。本发明中这些孔的设置辅助透视的定位孔，中间棘突上的孔是固定的模板作用。The two sides of the template are horizontal connection structures for marking and positioning; the middle part of the template is a navigation fixing and connection structure, and the two sides of the template are connected by the inclined structure of the template. Among them, individualized guide holes include spinous process positioning holes under fluoroscopy, pedicle projection center positioning holes under fluoroscopy, Kirschner wire positioning holes on the upper edge of the vertebral body under fluoroscopy, and pedicle hollows that can be adjusted appropriately under fluoroscopy. Guide hole for screw positioning needle, pedicle projection center positioning hole marked under fluoroscopy, used to pass through the pedicle projection center positioning needle marked under fluoroscopy, and Kirschner wire positioning hole marked under fluoroscopy on the upper edge of the vertebral body to pass through the fluoroscopy marked The positioning pin on the upper edge of the vertebral body, the spinous process positioning hole marked under fluoroscopy is used to pass through the spinous process positioning pin marked under fluoroscopy. In the present invention, these holes are set as positioning holes for auxiliary perspective, and the holes on the middle spinous process are fixed templates.
透视下标示棘突定位孔配合透视定位，安置透视定位克氏针。The spinous process positioning hole is marked under the fluoroscopy to coordinate with the fluoroscopy positioning, and the fluoroscopy positioning Kirschner wire is placed.
透视下标示椎弓根投影中心定位孔为2个，对称位于透视下标示棘突导航孔两侧，透视下标示椎体上缘克氏针定位孔为水平两侧贯通，分别设于左横连侧部和右横连侧部。Under fluoroscopy, there are 2 positioning holes for the center of the pedicle projection marked under fluoroscopy, which are located symmetrically on both sides of the spinous process navigation hole marked under fluoroscopy. Side and right cross connect the side.
透视下标示棘突定位孔位于模板中部底部，孔开口一端设于模板中部上侧面，一端设于模板中部下侧面；透视下标示椎弓根投影中心定位孔位于模板斜部结构处，孔开口一端设于模板斜部上侧面，另一端设于模板中部下侧面；透视下标示椎体上缘克氏针定位孔开口一端设于模板斜部上侧面且靠近顶端处，另一端水平设于横连端侧面；透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔位于导航固定及连接结构与横连结构的连接处，以个体化的内倾角度斜穿过模板上表面和模板下表面。Under fluoroscopy, the spinous process positioning hole is located at the bottom of the template, one end of the hole opening is set on the upper side of the template middle, and the other end is set on the lower side of the template middle; under the perspective, the pedicle projection center positioning hole is located at the oblique structure of the template, and the opening end of the hole is Set on the upper side of the inclined part of the template, and the other end is set on the lower side of the middle part of the template; one end of the Kirschner wire positioning hole opening on the upper edge of the vertebral body marked under perspective is set on the upper side of the inclined part of the template and near the top, and the other end is horizontally set on the horizontal connection End side: The pedicle hollow screw positioning needle guide hole that can be adjusted appropriately under the aid of perspective is located at the connection between the navigation fixation and connecting structure and the horizontal connecting structure, obliquely passing through the upper surface of the template and the lower surface of the template at an individual inclination angle.
导航固定及连接结构底部设有固定棘突定位孔，垂直穿过导航固定及连接结构上表面和导航固定及连接结构下表面，用以加强定位固定，不参与透视定位。There is a fixed spinous process positioning hole at the bottom of the navigation fixation and connection structure, which vertically passes through the upper surface of the navigation fixation and connection structure and the lower surface of the navigation fixation and connection structure to strengthen positioning and fixation, and does not participate in perspective positioning.
固定棘突导航孔个数3个，模板厚14mm，透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔个数10个，模板厚14mm或16mm。透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔也可以增加到10个以上，可以减少透视定位次数，可直接在不同的孔道调整，更方便于术中操作。The number of fixation spinous process navigation holes is 3, the thickness of the template is 14mm, the number of pedicle hollow screw positioning needle guide holes that can be adjusted appropriately with the aid of fluoroscopy is 10, and the thickness of the template is 14mm or 16mm. Under the aid of fluoroscopy, the number of pedicle hollow screw positioning needle guide holes that can be adjusted appropriately can also be increased to more than 10, which can reduce the number of fluoroscopy positioning, and can be directly adjusted in different holes, which is more convenient for intraoperative operation.
透视下标示棘突定位孔、透视下标示椎弓根投影中心定位孔、透视下标示椎体上缘克氏针定位孔和透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔的孔径为2.1mm，刚好能穿过2mm直径克氏针。棘突表浅，在椎弓根低位。可以用克氏针固定避免移位。The spinous process positioning hole is marked under fluoroscopy, the pedicle projection center positioning hole is marked under fluoroscopy, the Kirschner wire positioning hole on the upper edge of the vertebral body is marked under fluoroscopy, and the diameter of the pedicle hollow screw positioning pin guide hole that can be adjusted appropriately under fluoroscopy It is 2.1mm, just enough to pass through a 2mm diameter Kirschner wire. The spinous process is superficial and low in the pedicle. Can be fixed with Kirschner wires to avoid displacement.
实施例2Example 2
透视辅助的皮外个体化微创椎弓根螺钉导航模板，具有透视辅助的引导微创椎弓根螺钉导针进入的个体化导向孔、中部弯折形成一个凹形，且用于模板固定于皮外。The fluoroscopy-assisted extracutaneous individualized minimally invasive pedicle screw navigation template has a fluoroscopy-assisted individualized guide hole for guiding the minimally invasive pedicle screw guide needle to enter, and the middle part is bent to form a concave shape, and is used for fixing the template on the outside the skin.
模板两侧为横连结构，标示和定位；模板中部为导航固定及连接结构，模板两侧通过模板斜部结构相连接。其中，个体化导向孔包括透视下标示棘突定位孔、透视下标示椎弓根投影中心定位孔、透视下标示椎体上缘克氏针定位孔和透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔，透视下标示椎弓根投影中心定位孔用以穿过透视下标示椎弓根投影中心定位针，透视下标示椎体上缘克氏针定位孔用以穿过透视下标示椎体上缘定位针，透视下标示棘突定位孔用以穿过透视下标示棘突定位针。本发明中这些孔的设置辅助透视的定位孔，中间棘突上的孔是固定的模板作用。The two sides of the template are horizontal connection structures for marking and positioning; the middle part of the template is a navigation fixing and connection structure, and the two sides of the template are connected by the inclined structure of the template. Among them, individualized guide holes include spinous process positioning holes under fluoroscopy, pedicle projection center positioning holes under fluoroscopy, Kirschner wire positioning holes on the upper edge of the vertebral body under fluoroscopy, and pedicle hollows that can be adjusted appropriately under fluoroscopy. Guide hole for screw positioning needle, pedicle projection center positioning hole marked under fluoroscopy, used to pass through the pedicle projection center positioning needle marked under fluoroscopy, and Kirschner wire positioning hole marked under fluoroscopy on the upper edge of the vertebral body to pass through the fluoroscopy marked The positioning pin on the upper edge of the vertebral body, the spinous process positioning hole marked under fluoroscopy is used to pass through the spinous process positioning pin marked under fluoroscopy. In the present invention, these holes are set as positioning holes for auxiliary perspective, and the holes on the middle spinous process are fixed templates.
透视下标示椎弓根投影中心定位孔为2个，对称位于透视下标示棘突导航孔两侧，透视下标示椎体上缘克氏针定位孔为水平两侧贯通，分别设于左横连侧部和右横连侧部。Under fluoroscopy, there are 2 positioning holes for the center of the pedicle projection marked under fluoroscopy, which are located symmetrically on both sides of the spinous process navigation hole marked under fluoroscopy. Side and right cross connect the side.
透视下标示棘突定位孔位于模板中部底部，孔开口一端设于模板中部上侧面，一端设于模板中部下侧面；透视下标示椎弓根投影中心定位孔位于模板斜部结构处，孔开口一端设于模板斜部上侧面，另一端设于模板中部下侧面；透视下标示椎体上缘克氏针定位孔开口一端设于模板斜部上侧面且靠近顶端处，另一端水平设于横连端侧面；透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔位于导航固定及连接结构与横连结构的连接处，以个体化的内倾角度斜穿过模板上表面和模板下表面。Under fluoroscopy, the spinous process positioning hole is located at the bottom of the template, one end of the hole opening is set on the upper side of the template middle, and the other end is set on the lower side of the template middle; under the perspective, the pedicle projection center positioning hole is located at the oblique structure of the template, and the opening end of the hole is Set on the upper side of the inclined part of the template, and the other end is set on the lower side of the middle part of the template; one end of the Kirschner wire positioning hole opening on the upper edge of the vertebral body marked under perspective is set on the upper side of the inclined part of the template and near the top, and the other end is horizontally set on the horizontal connection End side: The pedicle hollow screw positioning needle guide hole that can be adjusted appropriately under the aid of perspective is located at the connection between the navigation fixation and connecting structure and the horizontal connecting structure, obliquely passing through the upper surface of the template and the lower surface of the template at an individual inclination angle.
导航固定及连接结构底部设有固定棘突定位孔，垂直穿过导航固定及连接结构上表面和导航固定及连接结构下表面，用以加强定位固定，不参与透视定位。横连上表面设有指示块。There is a fixed spinous process positioning hole at the bottom of the navigation fixation and connection structure, which vertically passes through the upper surface of the navigation fixation and connection structure and the lower surface of the navigation fixation and connection structure to strengthen positioning and fixation, and does not participate in perspective positioning. An indicator block is arranged on the upper surface of the horizontal connection.
固定棘突导航孔个数3个，模板厚15mm，透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔个数5个。There are 3 navigation holes for the fixed spinous process, the thickness of the template is 15mm, and the number of pedicle hollow screw positioning pin guide holes that can be adjusted appropriately with the aid of perspective is 5.
透视下标示棘突定位孔、透视下标示椎弓根投影中心定位孔、透视下标示椎体上缘克氏针定位孔和透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔的孔径为2.1mm，刚好能穿过2mm直径克氏针。模板边缘还可钝化处理，以避免压伤皮肤。The spinous process positioning hole is marked under fluoroscopy, the pedicle projection center positioning hole is marked under fluoroscopy, the Kirschner wire positioning hole on the upper edge of the vertebral body is marked under fluoroscopy, and the diameter of the pedicle hollow screw positioning pin guide hole that can be adjusted appropriately under fluoroscopy It is 2.1mm, just enough to pass through a 2mm diameter Kirschner wire. Template edges can also be passivated to avoid crushing the skin.
本发明中的有益效果：Beneficial effect among the present invention:
①引导微创置钉时能够明显减少手术时间、透视次数、减少医务人员及患者的辐射剂量，减少术中出血；① Guided minimally invasive nail placement can significantly reduce operation time, fluoroscopy times, radiation doses to medical staff and patients, and intraoperative bleeding;
②引导微创置钉较传统手术明显提高椎弓根螺钉的准确性和一致性；较光电导航引导下置钉也有更好的一致性。② Guided minimally invasive screw placement significantly improves the accuracy and consistency of pedicle screws compared with traditional surgery; it also has better consistency than photoelectric navigation guided screw placement.
③引导置钉在脊柱微创手术中具有应用及推广价值，易于基层医院推广。③ Guided screw placement has application and promotion value in minimally invasive spinal surgery, and is easy to promote in primary hospitals.
本发明中模板制备方法如下：Template preparation method in the present invention is as follows:
(一)三维模型的分割及建立(1) Segmentation and establishment of 3D model
术前患者行64排CT(西门子公司，德国)扫描；扫描条件：电压120kV，电流150mA,层厚0.625mm，矩阵512 512；采集的数据以DICOM格式存储；在Mimics14.11(Materialise公司，比利时)软件中导入原始Dicom格式数据。Preoperative patients underwent 64-slice CT (Siemens, Germany) scanning; scanning conditions: voltage 120kV, current 150mA, slice thickness 0.625mm, matrix 512 512; the collected data were stored in DICOM format; in Mimics14.11 (Materialise Company, Belgium ) software to import original Dicom format data.
通过“Crop project”工具选择所需固定节段缩小建模范围以提高设计速度；“Thresholding”工具获得胸腰椎原始蒙罩；“Regiongrowing”工具缩小并修改上述蒙罩(图4)；以此蒙罩上“Calcuate 3D”工具建立三维模型。Use the "Crop project" tool to select the required fixed segment to narrow the modeling range to increase the design speed; the "Thresholding" tool to obtain the original mask of the thoracolumbar spine; the "Regiongrowing" tool to narrow and modify the above mask (Fig. 4); Cover the "Calcuate 3D" tool to create a three-dimensional model.
(二)标准微创导针的设计(2) Design of standard minimally invasive guide needle
在Mimics软件“Medcad”菜单中，模拟置入直径2.1mm的圆柱体，此圆柱体即表示虚拟置入的微创椎弓根螺钉导针。虚拟导针在Mimics软件中满足以下条件：①“OnlineReslice”在导针进钉点水平切割，标准前后位模拟X线片导针位于椎弓根投影外侧边缘，左右侧3枚螺钉进钉点分布在同一直线上；②“Online Reslice”在导针完全通过椎弓根水平切割，标准前后位模拟X线片导针位于椎弓根投影内侧边缘；③三维模型中观察，矢状位螺钉进钉方向与椎体上终板平行，同一椎体椎弓根螺钉进钉点与进钉方向左右侧对称。In the "Medcad" menu of the Mimics software, a cylinder with a diameter of 2.1 mm was simulated and placed, and this cylinder represented a virtual minimally invasive pedicle screw guide pin. The virtual guide wire in the Mimics software meets the following conditions: ① "Online Reslice" is cut horizontally at the guide pin entry point, the standard anterior-posterior simulated X-ray film guide pin is located at the outer edge of the pedicle projection, and the distribution of the three screw entry points on the left and right sides On the same straight line; ②"Online Reslice" cuts the guide wire completely through the pedicle horizontally, and the standard anterior-posterior simulated X-ray film guide wire is located on the inner edge of the pedicle projection; ③Observed in the three-dimensional model, the screw enters the screw in the sagittal position The direction is parallel to the upper endplate of the vertebral body, and the pedicle screw entry point of the same vertebra is symmetrical to the left and right sides of the screw entry direction.
(三)透视辅助下定位针和可选择模拟微创导针的设计(3) Design of fluoroscopy-assisted positioning needle and optional simulated minimally invasive guide needle
皮外个体化模板并不是以皮肤的外部形态为模板制作而成的，因此需结合透视辅助才能确定术中模板的位置，因此我们设计了平行于椎体上缘的定位针三根、通过棘突及双侧椎弓根中心的定位针三根，共计六根透视定位针，定位针直径2.1mm；我们也考虑到不同体位及皮肤厚度的影响所以设计了若干平行于标准微创导针的钉道，钉道直径2.1mm，上述钉道与定位针及椎体三位模型以STL文件保存。The extracutaneous individualized template is not made from the external shape of the skin, so the position of the template in the operation needs to be combined with the aid of perspective. Therefore, we designed three positioning needles parallel to the upper edge of the vertebral body, passing through the spinous process and three positioning pins in the center of the bilateral pedicles, a total of six fluoroscopy positioning pins, with a diameter of 2.1mm; we also considered the influence of different body positions and skin thickness, so we designed several screw paths parallel to the standard minimally invasive guide pins, The diameter of the screw track is 2.1mm, and the three-dimensional model of the above screw track, positioning pin and vertebral body is saved as an STL file.
(三)模板的设计和打印(3) Template design and printing
模板的设计步骤如下：①在Geomagic Studio 2013软件(Geomagic公司，美国)中同时导入上述STL文件；②通过Geomagic Studio软件设计紧贴皮肤的模板，模板厚度15mm，边缘钝化避免压迫皮肤；③使用“画圈”工具删除虚拟钉道2.1mm的内芯，此内芯即为微创椎弓根螺钉导针的导航通道；④同时使用“画圈”工具删除透视定位针2.1mm的内芯，此内芯即为术中辅助模板透视定位的克氏针通道；⑤为便于模板的皮外固定，我们个体化的设计了穿刺进入棘突的克氏针；⑥模板通过纵向的克氏针使其成为一整体，这样既可以减少其晃动提高准确度，同时也可以在体位变化时对微创导针进行一定范围的调节；⑦在模板表面上设计患者的姓名和节段标记，便于术中区别。The design steps of the template are as follows: ① Import the above STL files into the Geomagic Studio 2013 software (Geomagic, USA); ② Design a template that is close to the skin through the Geomagic Studio software. The "circle" tool deletes the 2.1mm inner core of the virtual screw path, which is the navigation channel of the minimally invasive pedicle screw guide pin; ④ simultaneously uses the "circle" tool to delete the 2.1mm inner core of the fluoroscopy positioning needle, This inner core is the Kirschner wire channel that assists the fluoroscopy positioning of the template during the operation; ⑤ In order to facilitate the extracutaneous fixation of the template, we individually designed the Kirschner wire that punctures into the spinous process; ⑥ The template uses the longitudinal Kirschner wire to It becomes a whole, which can not only reduce its shaking and improve accuracy, but also adjust the minimally invasive guide needle to a certain range when the body position changes; ⑦ design the patient's name and segment marks on the surface of the template, which is convenient for operation the difference.
将上述数字化模型保存为STL格式文件传入3D打印机(3D SYSTEMS公司，美国)进行3D实物打印，打印材料为树脂材料(3D SYSTEMS公司，美国)。The above digital model is saved as an STL format file and transferred to a 3D printer (3D SYSTEMS, USA) for 3D physical printing, and the printing material is a resin material (3D SYSTEMS, USA).
本发明导航模板在术中的过程：The intraoperative process of the navigation template of the present invention:
术中内固定均为长臂单芯椎弓根螺钉系统(北京市富乐科技开发有限公司，中国)，全麻后患者取悬空腹部的俯卧位。使用C型臂X线机以伤椎为中心标准正位摄片，确认棘突位于左右侧椎弓根投影连线的中心位置。体表标记伤椎及相邻头尾侧椎体上缘、各椎体棘突的连线及左右侧椎弓根投影的连线。选直径2mm克氏针1枚分别穿入上述各模板的横向透视定位孔，再选3枚穿入纵向透视定位孔，标准正位摄片确认透视克氏针达到术前设计要求(横向透视克氏针位于各椎体上缘、纵向透视克氏针分别位于棘突连线和两侧椎弓根投影中心连线)，用较短的直径2mm克氏针击入棘突并用手术粘性贴膜固定。The internal fixation during the operation was the long-arm single-core pedicle screw system (Beijing Fule Technology Development Co., Ltd., China). After general anesthesia, the patient was placed in a prone position with the abdomen suspended. Use a C-arm X-ray machine to take standard anteroposterior photographs centered on the injured vertebra, and confirm that the spinous process is located at the center of the projection line connecting the left and right pedicles. The body surface marks the injured vertebra and the upper edge of the adjacent craniocaudal vertebral body, the line connecting the spinous processes of each vertebra, and the line connecting the left and right pedicle projections. One Kirschner wire with a diameter of 2 mm was selected to penetrate into the horizontal fluoroscopy positioning hole of the above-mentioned templates, and another 3 pieces were selected to penetrate into the longitudinal fluoroscopy positioning hole. The Kirschner wires are located on the upper edge of each vertebral body, and the Kirschner wires are located on the line connecting the spinous processes and the projection centers of the pedicles on both sides respectively in longitudinal perspective), and the short 2mm diameter Kirschner wires are driven into the spinous processes and fixed with surgical adhesive film .
以上述正位摄片为基准在模板上选择大致合适的导向孔，经皮依次击入直径2mm克氏针共计6枚，到达骨质后，行正侧位摄片，依据X线片选择临近导向孔调整定位克氏针，直至击入的克氏针调整到正位达到椎弓根投影边缘，侧位与椎体上终板平行(与术前设计相同)，继续击入克氏针，使其针尖侧位达到椎体后壁时，正位位于椎弓根投影内侧，继续击入克氏征进入椎体前1/3。依次沿定位克氏针逐级放入扩张套筒和保护套筒，用中空丝攻沿定位克氏针扩大钉道，选择合适直径和长度的长臂单芯椎弓根螺钉沿定位克氏针拧入椎体，共计置入6枚，伤椎选用的螺钉长度稍短。适当调整手术床的角度，通过体位复位伤椎。按吴超等方法选择合适长度的连接棒进行预弯，连接棒由切口经皮依次插入3枚长臂单芯钉底部。置入螺钉尾帽，适当撑开复位椎体并锁紧，折断钉尾，术毕。Based on the above-mentioned anteroposterior radiographs, select a roughly suitable guide hole on the template, and drill a total of 6 Kirschner wires with a diameter of 2 mm percutaneously. The guide hole is adjusted to position the Kirschner wire until the inserted Kirschner wire is adjusted to the positive position and reaches the projection edge of the pedicle, and the lateral position is parallel to the upper endplate of the vertebral body (same as the preoperative design), and the Kirschner wire is continued to be driven in. When the needle tip laterally reaches the posterior wall of the vertebral body, it is positioned anteriorly on the medial side of the pedicle projection, and continues to drive into the Klinefelter sign to enter the anterior 1/3 of the vertebral body. Insert expansion sleeves and protective sleeves step by step along the positioning Kirschner wires in turn, expand the screw path along the positioning Kirschner wires with a hollow wire tap, and select long-arm single-core pedicle screws of appropriate diameter and length along the positioning Kirschner wires. A total of 6 screws were screwed into the vertebral body, and the length of the screw used for the injured vertebra was slightly shorter. Properly adjust the angle of the operating table, and reset the injured vertebra through posture. According to the method of Wu Chao et al., the connecting rods of appropriate length were selected for pre-bending, and the connecting rods were sequentially inserted through the incision into the bottom of three long-arm single-core nails. Insert the screw tail cap, properly propel and reset the vertebral body and lock it, break off the screw tail, and the operation is completed.
本发明中的导航模板制备用时不长，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模板打印可以在12h内完成。对于没有3D打印机和模板设计能力的基层医院也可通过互联网路，上传原始数据，外包设计模板及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，目前模板的打印成本并不高，对患者的经济负担影响不大，反而应用模板可以为手术医生提供更多的技术保障，逐渐提高其技术，减少患者并发症，使患者受益。The preparation time of the navigation template in the present invention is not long, can meet the requirements of clinical operations, and has generalizability. This group of patients can be completed within 12 hours from admission data extraction to template printing. For grassroots hospitals without 3D printers and template design capabilities, they can also upload original data through the Internet, outsource design templates and 3D physical printing, and then deliver them through logistics express. With the increasing popularity of 3D printing, the cost of template printing is not high at present, and has little impact on the economic burden of patients. On the contrary, the application of templates can provide surgeons with more technical support, gradually improve their technology, and reduce patients' complications. benefit patients.
效果例1Effect Example 1
患者男性，55岁，以“腰部疼痛活动困难3+小时”为主诉求治。3+小时前，患者因车祸伤致腰部疼痛活动困难入院。伤后清醒，无呕吐及胸腹痛，不办双下肢麻木无力。专科检查：脊柱于胸腰段后凸畸形，叩压痛明显，腰部活动明显受限。入院DR及CT提示：腰2椎体爆裂性骨折。入院诊断：腰2椎体爆裂骨折。The patient is a 55-year-old male who seeks treatment with the main complaint of "lumbar pain and difficulty in moving for 3+ hours". 3+ hours ago, the patient was admitted to the hospital due to waist pain and difficulty moving due to a car accident injury. Awake after injury, no vomiting and chest and abdominal pain, no numbness and weakness in both lower extremities. Specialist examination: kyphotic deformity in the thoracolumbar segment of the spine, obvious percussion and tenderness, and obvious limitation of waist movement. Admission DR and CT showed: burst fracture of lumbar 2 vertebrae. Admission diagnosis: burst fracture of lumbar 2 vertebrae.
入院后完善相关术前准备，无绝对手术禁忌后，拟行后路微创椎弓根螺钉固定术。术前将患者原始CT数据导入Mimics软件中，制作本专利介绍的“透视辅助的皮外个体化微创椎弓根螺钉导航模板”并通过3D打印机打印出实物。术中应用此模板，透视定位后模板能很好的固定于皮外，无移动；术中通过模板的“透视辅助下可适当调整的椎弓根空心螺钉定位针导向孔”，可以安全的置入空心螺钉定位针，并顺利置入空心椎弓根螺钉固定病变椎体。手术时间较传统透视下定位的2小时，光电导航下的2.5小时，缩短为1小时左右。透视次数和术中出血也较上述方式明显减少。术后CT检查，螺钉未突破椎弓根皮质，所有螺钉一次性穿刺成功，矢状面螺钉植入角、螺钉矢状面夹角差、螺钉进钉点高度差、螺钉内倾角差值等均为“优”。术后1年复查螺钉无松动，骨折愈合良好，患者未诉特殊不适。After admission to the hospital, relevant preoperative preparations were completed, and if there were no absolute surgical contraindications, a posterior minimally invasive pedicle screw fixation was planned. Import the original CT data of the patient into the Mimics software before the operation, make the "perspective-assisted extracutaneous individualized minimally invasive pedicle screw navigation template" introduced in this patent, and print out the real thing through a 3D printer. Using this template during the operation, the template can be well fixed outside the skin without movement after fluoroscopy positioning; during the operation, the "pedicle hollow screw positioning needle guide hole that can be adjusted appropriately under the aid of fluoroscopy" of the template can be safely placed. Hollow screw positioning pins were inserted, and hollow pedicle screws were successfully placed to fix the diseased vertebral body. The operation time is shortened to about 1 hour compared with 2 hours under traditional fluoroscopy and 2.5 hours under photoelectric navigation. The number of fluoroscopy and intraoperative bleeding are also significantly reduced compared with the above methods. Postoperative CT examination showed that the screw did not break through the pedicle cortex, and all the screws were successfully punctured at one time. as "Excellent". One year after the operation, the screws were not loosened, the fracture healed well, and the patient did not complain of any special discomfort.
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention should be included in the protection of the present invention. within range.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610506151.3ACN106175908B (en) | 2016-06-29 | 2016-06-29 | A kind of minimally invasive pedicle screw navigation template of outer individuation of the skin for having an X-rayed auxiliary |
| Application Number | Priority Date | Filing Date | Title |
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| CN201610506151.3ACN106175908B (en) | 2016-06-29 | 2016-06-29 | A kind of minimally invasive pedicle screw navigation template of outer individuation of the skin for having an X-rayed auxiliary |
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| CN106175908A CN106175908A (en) | 2016-12-07 |
| CN106175908Btrue CN106175908B (en) | 2017-10-27 |
| Application Number | Title | Priority Date | Filing Date |
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| CN201610506151.3AActiveCN106175908B (en) | 2016-06-29 | 2016-06-29 | A kind of minimally invasive pedicle screw navigation template of outer individuation of the skin for having an X-rayed auxiliary |
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