Guide plate structure for spinal surgery and its manufacturing method and use method

Abstract

The present invention discloses a guide plate for spinal surgery, comprising a guide plate body, the guide plate body comprising an inner side surface matching the posterior surface of the vertebral body of the surgical segment, a guide hole being provided on the guide plate body, the outer surface of the guide block being conical, a drill hole being provided on the guide plate body corresponding to the guide block, the drill hole matching the outer surface of the front end of the guide block, and the guide block being embedded in the drill hole. The present invention also relates to a method for making and using the guide plate. The inner side surface of the guide plate used in the present invention matches the posterior surface of the vertebral body. Since the shape of the posterior surface of the vertebral body is irregular, when the guide plate covers the adaptation area, the inner side surface of the guide plate fits the posterior surface of the vertebral body and is not easy to move when appropriate pressure is applied. The most important thing is that the guide block can be taken out before inserting the guide pin, the grinding drill bit is first positioned and polished at the position where the screw needs to be inserted, and the guide block is inserted after the surface cortical bone is removed, so that the operator can insert the guide pin along the guide hole on the guide plate conveniently, so that the whole operation can be completed more accurately and quickly with the assistance of the guide plate.

Description

Technical Field

[0001] The present invention relates to a spinal surgical guide plate structure and a manufacturing method thereof. The present invention also relates to a manufacturing method of the spinal surgical guide plate. The present invention also relates to a method for using the spinal surgical guide plate. Background Art

[0002] In spinal surgery, posterior pedicle screw fixation is undoubtedly the most basic surgical operation. However, accurate screw placement is always difficult, which depends on the variation of anatomical morphology, the size and direction of the pedicle. Especially for patients with cervical and thoracic vertebrae, and even more so spinal deformities, their structures are complex and there are individual differences, resulting in large variability in their structures. Freehand screw placement without the aid of auxiliary navigation tools has a higher risk. Foreign literature reports that the error rate of freehand pedicle screw placement is 10%-40%, and it is easy to cause serious vascular and nerve damage.

[0003] Therefore, a 3D printing rapid prototyping template technology based on individual patients is used to assist the placement of pedicle screws. Due to its lower price and simple operation, this technology has been improved and now has been promoted to pedicle screw fixation in various parts of the spine.

[0004] The rapid prototyping navigation template technology was first used by Radermacher et al. in 1998 for the study of lumbar pedicle screw placement. Later, the technology was promoted and improved and is now widely used in the study of screw placement in the cervical spine, thoracic spine, lumbar spine, and more complex atlantoaxial spine, scoliosis, etc.

[0005] In the use of ordinary spinal surgery guides, for patients or parts with high bone density and hard cortical bone at the back of the vertebra, it is difficult for the guide needle to break through the corresponding vertebral cortical bone. The guide needle is easy to slip on the untreated cortical bone surface, resulting in inaccurate positioning, increasing the difficulty of guide needle insertion, and even failure of insertion. In addition, the manufacturing precision of existing guides is not accurate enough to ensure the accuracy of guide needle insertion, which in turn affects the insertion of hollow screws. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a guide plate for spinal surgery, which has a higher precision and can more effectively assist the operation, and can position and polish the nail entry point to facilitate the insertion of the guide needle. The technical problem to be solved by the present invention also includes providing a method for making the above-mentioned guide plate for spinal surgery, and the guide plate obtained by the manufacturing method has higher precision. The technical problem to be solved by the present invention also includes providing a method for using the above-mentioned guide plate for spinal surgery.

[0007] To this end, the present invention provides a guide plate for spinal surgery, including a guide plate body, the guide plate body including an inner side surface matching the posterior surface of the surgical segment vertebra, a guide hole is provided on the guide plate body facing the position where the guide needle needs to be inserted, the upper side of the guide hole has a convex edge, the guide hole is arranged on a guide block, the outer surface of the guide block is conical, a drill hole is provided on the guide plate body corresponding to the guide block, the drill hole matches the outer surface of the front end of the guide block, and the guide block is embedded in the drill hole.

[0008] Furthermore, the inner wall of the drill hole is provided with an embedding groove, and the outer wall of the guide block is provided with an embedding block, and after the guide block is embedded in the drill hole, the embedding block is embedded in the embedding groove.

[0009] Furthermore, a magnetic attraction mechanism A matching the guide block is provided on the embedding groove and / or the side wall of the drilled hole, and a magnetic attraction mechanism B matching the magnetic attraction mechanism A is provided on the front end side wall of the guide block and the embedding block. After the guide block and the embedding block are respectively inserted into the drilled hole and the embedding groove, the magnetic attraction mechanism A is attracted to the magnetic attraction mechanism B.

[0010] Furthermore, the guide plate body includes a lower plate and an upper plate, the inner side surface is on the lower plate, the inner side surface has an anti-slip layer, and the upper plate and the lower plate are attached to and fixed to each other.

[0011] Furthermore, the anti-slip layer is a silicone material layer, and staggered drainage grooves are distributed on the silicone material layer.

[0012] Furthermore, the guide plate body is made of transparent material.

[0013] Furthermore, the inner side of the borehole is lined with a metal pad, the cross-section of the lower port of the borehole is circular, the cross-section of the upper portion of the borehole is elliptical, square, triangular, pentagonal or polygonal, and the side wall of the guide block is provided with a magnet that can achieve magnetic attraction with the metal pad.

[0014] The present invention provides a method for manufacturing the spinal surgery guide plate, comprising the following steps:

[0015] A. Perform a preoperative CT scan on the patient to obtain the image data of the target surgical segment vertebra and perform three-dimensional reconstruction;

[0016] B. Setting the screw diameter and determining the screw track data on the guide plate according to the two-dimensional images in each direction;

[0017] C. Design a spinal surgery guide based on the data obtained in steps A and B, and perform 3D printing.

[0018] Furthermore, the above method specifically comprises the following steps:

[0019] A. Obtain the patient's CT image data from the PACS system, save it in *.Dcm format, and then import it into Mimics software to generate views in three different directions: axial, coronal, and sagittal.

[0020] Use the Segment module function in Mimics to select the segment area to be operated on;

[0021] B. Simulate the insertion of pedicle screws, set the screw diameter, and determine the screw track based on 2D images in all directions;

[0022] The segments to be operated on and the simulated nail tracts were exported from Mimics and imported into Geomagic to select the guide plate area and perform area thickening to produce a thin plate model.

[0023] The thin plate model data generated in Geomagic was exported and then imported back into Mimics software to make the guide plate model. The length and diameter of the cylinder used to simulate the nail channel were adjusted to determine the length, inner diameter and outer diameter of the guide channel on the required guide plate model. The Boolean function in Mimics software was used to perform Boolean operations between the guide plate components to make the required guide plate model.

[0024] C. 3D print the finished product according to the guide plate model data.

[0025] The present invention provides a method for using the above-mentioned guide plate for spinal surgery, comprising: A. removing the guide block on the guide plate; B. placing the inner side of the guide plate against the vertebral body adaptation surface, and positioning the position of the nail entry point on the posterior surface of the vertebral body by drilling; C. then embedding the guide block into the drill hole, and using the guide hole on the guide block to accurately guide the guide needle for the insertion of the hollow screw.

[0026] Technical effects of the present invention:

[0027] 1. The inner side of the guide plate of the present invention matches the surface of the spinal lamina. Since the surface of the spinal bones is irregular in shape, when the guide plate covers the adaptation area, the inner side of the guide plate fits the surface of the spinal bones and proper pressure is applied, so it is not easy to move;

[0028] 2. In the present invention, before inserting the guide pin, the guide block can be taken out first, and the grinding drill bit is first positioned and ground at the position where the screw needs to be driven in (i.e., the position where the drill hole is exposed), and then the guide block is inserted after grinding, so that the operator can insert the guide pin along the guide hole on the guide plate conveniently. Since the diameter of the front end of the drill hole is about 3MM, and the diameter of the guide hole is 1.8MM, setting the guide hole on the guide block can make up for the aperture difference, so that the entire operation can be completed more accurately and quickly with the assistance of the guide plate. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a schematic diagram of the three-dimensional structure of the guide plate provided in Example 1 of the present invention.

[0030] Figure 2 for Figure 1 Schematic diagram of the side structure.

[0031] Figure 3 for Figure 1 A schematic partial cross-sectional view of the guide hole in FIG.

[0032] Figure 4 for Figure 3 Schematic diagram of the split structure at the guide hole.

[0033] Figure 5 for Figure 3 A schematic cross-sectional view of the partial structure of the guide plate after the guide plate is configured with an embedding block and an embedding groove.

[0034] Figure 6 for Figure 5 A schematic diagram of a partial top view of the drilling hole of the guide plate.

[0035] Figure 7 A schematic cross-sectional view of the local structure of the drilling hole of the guide plate provided in Example 2 of the present invention.

[0036] Figure 8 for Figure 7 A schematic plan view of the local structure of the silicone material layer on the inner side of the guide plate.

[0037] Fig. 9 This is a schematic diagram of the partial structure of the guide plate provided in Example 3 of the present invention.

[0038] Fig.10 for Fig. 9 Schematic diagram of the top view of the drilling hole of the guide plate. DETAILED DESCRIPTION

[0039] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. The same parts are represented by the same reference numerals. It should be noted that the words "front", "rear", "left", "right", "upper" and "lower" used in the following description refer to directions in the accompanying drawings, and the words "bottom surface" and "top surface", "inner" and "outer" refer to directions toward or away from the geometric center of a specific component, respectively.

[0040] Reference Figure 1-6As shown, the guide plate for spinal surgery provided in Example 1 of the present invention includes a guide plate body, the guide plate body includes an inner side surface 1 matching the posterior surface of the surgical segment vertebral body, a guide hole 2 is provided on the guide plate body opposite to the position where the guide needle needs to be inserted, and the upper side of the guide hole 2 has a convex edge 3, the guide hole 2 is arranged on a guide block 4, the outer surface of the guide block 4 is conical, a drill hole 5 is provided on the guide plate body corresponding to the guide block 4, the drill hole 5 matches the outer surface of the front end of the guide block 4, and the guide block 4 is embedded in the drill hole 5.

[0041] Reference Figure 5-6 As shown, the inner wall of the borehole is provided with an embedding groove 6, and the outer wall of the guide block is provided with an embedding block 7. After the guide block 4 is embedded in the borehole 5, the embedding block 7 is embedded in the embedding groove 6. The structure of the embedding block 7 and the embedding groove 6 is conducive to maintaining the stable setting of the embedding block 7. The embedding groove 6 and / or the side wall of the borehole 5 are provided with a magnetic attraction mechanism A8 matching the guide block, and the front side wall of the guide block 4 and the embedding block 7 are provided with a magnetic attraction mechanism B9 matching the magnetic attraction mechanism A8. After the guide block 4 and the embedding block 7 are respectively inserted into the borehole 5 and the embedding groove 6, the magnetic attraction mechanism A8 is attracted to the magnetic attraction mechanism B9. The magnetic attraction mechanism further improves the firmness and convenience of the combination of the guide block 4 and the guide plate body.

[0042] In order to observe the surgical status, in the above-mentioned embodiment 1, the guide plate body is made of transparent material.

[0043] Reference Figure 1-6 As shown, the method for manufacturing the spinal surgery guide plate provided in Example 1 of the present invention comprises the following steps:

[0044] A. Perform CT scan on the patient to obtain the image data of the target surgical segment vertebra and perform three-dimensional reconstruction;

[0045] B. Setting the screw diameter and determining the screw track data on the guide plate according to the two-dimensional images in each direction;

[0046] C. Design a spinal surgery guide based on the data obtained in steps A and B, and perform 3D printing.

[0047] Further, the method specifically includes the following steps:

[0048] A. Obtain cervical spine CT image data (scanning layer thickness of about 1 mm) from the PACS system, save it in *.Dcm format, and then import it into Mimics software to generate views in three different directions: axial, coronal, and sagittal.

[0049] Use the Segment module function in Mimics to select the segment area to be operated on;

[0050] B. Simulate the insertion of pedicle screws, set the screw diameter, and determine the screw track based on 2D images in all directions;

[0051] The segments to be operated on and the simulated nail tracts were exported from Mimics and imported into Geomagic to select the guide plate area and perform area thickening to produce a thin plate model.

[0052] The thin plate model data generated in Geomagic was exported and then imported back into Mimics software to make the guide plate model. The length and diameter of the nail channel simulation cylinder were adjusted to determine the length, inner diameter and outer diameter of the guide channel on the required guide plate model. The Boolean function in Mimics software was used to perform Boolean operations between the guide plate components to make the required guide plate model.

[0053] C. 3D print the finished product according to the guide plate model data.

[0054] The guide plate making method described above can make the guide plate more conveniently and accurately in combination with the bone surface data to be operated on.

[0055] Reference Figure 1-6 As shown, the method for using the guide plate for spinal surgery provided by Example 1 of the present invention includes: A. removing the guide block 4 on the guide plate; B. placing the inner side of the guide plate against the vertebral body adapting surface, and using the drill hole 5 to locate the position of the nail entry point on the posterior surface of the vertebral body; C. then embedding the guide block 4 into the drill hole 5, and using the guide hole 2 on the guide block 4 to accurately guide the guide needle for the insertion of the hollow screw. The method for using the guide plate can accurately and effectively pre-grind the cortical bone surface of the surgical vertebral body nail entry point.

[0056] Reference Figure 7 As shown, Embodiment 2 of the present invention is basically the same as Embodiment 1, and the only difference is that: the guide plate body includes a lower plate 10 and an upper plate 11, the inner side surface is on the lower plate 10, the inner side surface has an anti-skid layer, the upper plate and the lower plate are attached and fixed to each other, the anti-skid layer is a silicone material layer 12, and the silicone material layer 12 is provided with staggered drainage grooves 13. The silicone material layer 12 in this embodiment can improve the anti-skid performance of the guide plate and the bone, and the drainage groove 13 can timely drain the liquid remaining on the bone surface to avoid affecting the anti-skid performance.

[0057] Reference Figure 8-9As shown, Embodiment 3 of the present invention is basically the same as Embodiment 1, and the only difference is that: the inner side of the borehole is lined with a metal cushion layer 14, the lower end cross section of the borehole is circular, the upper cross section of the borehole is elliptical, square, triangular, pentagonal or polygonal, and the side wall of the guide block is provided with a magnet 15 that can achieve magnetic attraction with the metal cushion layer. The metal cushion layer 14 can prevent the drill bit from directly colliding with the plastic guide plate body when grinding the cortical bone at the borehole, thereby preventing the generation of plastic debris that affects the surgical effect.

[0058] The above is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention. It should be pointed out that for ordinary technicians in this technical field, some improvements and modifications without departing from the principle of the present invention should also be regarded as the protection scope of the present invention.

Claims

1. A guide plate for spinal surgery, comprising a guide plate body, characterized in that: The guide plate body includes an inner side surface matching the posterior surface of the surgical segment vertebral body, a guide hole is provided on the guide plate body facing the position where the guide pin needs to be inserted, a convex edge is provided on the upper side of the guide hole, the guide hole is provided on the guide block, the outer surface of the guide block is conical, a drill hole is provided on the guide plate body corresponding to the guide block, the drill hole matches the outer surface of the front end of the guide block, the guide block is embedded in the drill hole, the diameter of the front end of the drill hole is larger than the diameter of the guide hole, the guide block is first taken out before inserting the guide pin, the grinding drill bit is positioned and polished at the position where the drill hole is exposed, and the guide block is inserted after polishing, so that the operator can insert the guide pin along the guide hole on the guide plate conveniently; The inner wall of the drill hole is provided with an embedding groove, and the outer wall of the guide block is provided with an embedding block. After the guide block is embedded in the drill hole, the embedding block is embedded in the embedding groove; a magnetic attraction mechanism A matching the guide block is provided on the embedding groove and / or the side wall of the drill hole, and a magnetic attraction mechanism B matching the magnetic attraction mechanism A is provided on the front side wall of the guide block and the embedding block. After the guide block and the embedding block are respectively inserted into the drill hole and the embedding groove, the magnetic attraction mechanism A is attracted to the magnetic attraction mechanism B; The guide plate body comprises a lower plate and an upper plate, the inner side surface is on the lower plate, the inner side surface has an anti-skid layer, the upper plate and the lower plate are attached to and fixed to each other; the anti-skid layer is a silicone material layer, and the silicone material layer is provided with staggered drainage grooves.

2. The guide plate for spinal surgery according to claim 1, characterized in that: The guide plate body is made of transparent material.

3. The guide plate for spinal surgery according to claim 1, characterized in that: The inner side of the borehole is lined with a metal pad, the lower port cross-section of the borehole is circular, the upper cross-section of the borehole is elliptical, square, triangular, pentagonal or polygonal, and the side wall of the guide block is provided with a magnet that can achieve magnetic attraction with the metal pad.

4. A method for manufacturing a guide plate for spinal surgery as claimed in claim 1, 2 or 3, characterized in that: The following steps are involved: A. Perform a preoperative CT scan on the patient to obtain the image data of the target surgical segment vertebra and perform three-dimensional reconstruction; B. Setting the screw diameter and determining the screw track data on the guide plate according to the two-dimensional images in each direction; C. Design a spinal surgery guide based on the data obtained in steps A and B, and perform 3D printing.

5. The method for manufacturing a guide plate for spinal surgery according to claim 4, characterized in that: The specific steps include: A. Obtain the patient's CT image data from the PACS system, save it in *.Dcm format, and then import it into Mimics software to generate views in three different directions: axial, coronal, and sagittal. Use the Segment module function in Mimics to select the segment area to be operated on; B. Simulate the insertion of pedicle screws, set the screw diameter, and determine the screw track based on 2D images in all directions; The segments to be operated on and the simulated nail tracts were exported from Mimics and imported into Geomagic to select the guide plate area and perform area thickening to produce a thin plate model. The thin plate model data generated in Geomagic was exported and then imported back into Mimics software to make the guide plate model. The length and diameter of the cylinder used to simulate the nail channel were adjusted to determine the length, inner diameter and outer diameter of the guide channel on the required guide plate model. The Boolean function in Mimics software was used to perform Boolean operations between the guide plate components to make the required guide plate model. C. 3D print the finished product according to the guide plate model data.

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