Pedicle screw placement guide plate and preparation method thereof

Abstract

The present invention provides a pedicle screw placement guide plate and a preparation method thereof. The prepared screw placement guide plate can safely and accurately place pedicle screws, reduce surgical risks and trauma, and improve the quality of life of patients. The pedicle screw placement guide plate comprises a transverse column, a lateral column, and a needle channel column. Needle channels are arranged at both ends of the transverse column, each needle channel is vertically extended downward and provided with a lateral column, each needle channel is obliquely extended downward and provided with a needle channel column, the lateral column and the needle channel column share an input end, and the inner cavity of the needle channel column is connected to the needle channel. The pedicle screw placement guide plate comprises the following steps: obtaining a CT image of a target vertebra of a patient, importing the image into 3D modeling software to establish a 3D model of the target vertebra; establishing a pedicle screw placement guide plate model, planning the optimal screw insertion point and direction of a pre-placed screw on the 3D model of the target vertebra using a cylinder with a diameter of 4 mm in the 3D modeling software, then establishing a needle channel column to surround the cylinder, and sequentially establishing a transverse column, a lateral column, and a diagonal support column to obtain an initial model.

Description

Technical Field

[0001] The present invention relates to the field of medical instruments, and in particular to a pedicle screw placement guide plate and a preparation method thereof. Background Art

[0002] In existing technologies, pedicle screw placement is the basis of posterior spinal fixation surgery and a key step. Accurate pedicle screw placement is particularly important in reducing complications and ensuring therapeutic efficacy. Biomechanical experiments have shown that only by inserting screws along the anatomical long axis of the pedicle and reaching the ideal depth can an ideal fixation effect be achieved.

[0003] Due to the complex anatomical structure of the spine, individual differences among patients, and the operator's proficiency, traditional manual screw placement technology is prone to deviations in finding the entry point and direction of screw placement. In mild cases, this may affect the fixation effect, prolong the operation time, increase surgical trauma and bleeding, infection rate, and pain in the surgical area. In severe cases, it may damage the patient's spinal cord, nerve roots, and blood vessels.

[0004] Currently, the main methods for determining pedicle screw insertion angles and points include anatomical landmarks, fluoroscopy, computer navigation, and navigation templates. The anatomical landmark method primarily relies on the surgeon's experience to determine the insertion point and angle, requiring high clinical experience and difficult to guarantee accuracy. The fluoroscopy-assisted method is time-consuming and increases radiation exposure for both patients and medical staff. Computer navigation, which utilizes real-time pedicle imaging to guide surgery, offers significant advantages, but the equipment is expensive, difficult to operate, and limited widespread adoption. With the application of 3D-printed navigation templates, various studies, both domestic and international, have demonstrated high accuracy in pedicle screw placement at all vertebral levels, significantly reducing the incidence of screw misentry into the spinal canal and cortical perforation. However, conventional guides, designed to maintain close contact with the bone surface, require extensive soft tissue dissection and clearance during surgery, which can still lead to issues associated with freehand screw placement. Summary of the Invention

[0005] The purpose of the present invention is to provide a pedicle screw placement guide plate and a preparation method thereof, wherein the prepared screw placement guide plate can safely and accurately place pedicle screws, reduce surgical risks and trauma, and improve the quality of life of patients.

[0006] The embodiment of the present invention is achieved as follows:

[0007] A pedicle screw placement guide plate includes a transverse column, a side column and a needle channel column. Needle channels are provided at both ends of the transverse column. Each needle channel is provided with a side column extending vertically downward. Each needle channel is provided with a needle channel column extending obliquely downward. The side columns and the needle channel columns share an input end, and the inner cavity of the needle channel column is communicated with the needle channel.

[0008] In a preferred embodiment of the present invention, the pedicle screw placement guide plate further includes an oblique support column, which extends from the middle of the needle track column or the side column, and has an inclination angle with the needle track column and the side column respectively.

[0009] In a preferred embodiment of the present invention, the top of the horizontal column is a flat surface, and the bottom surface of the horizontal column is a bone-engaging surface.

[0010] In a preferred embodiment of the present invention, the output end surfaces of the side columns, needle channel columns and diagonal support pillars are bone-engaging surfaces.

[0011] In a preferred embodiment of the present invention, the interiors of the horizontal columns, side columns and diagonal bracing pillars are hollow.

[0012] In a preferred embodiment of the present invention, a horizontal column opening is provided in the middle of the horizontal column.

[0013] In a preferred embodiment of the present invention, the pedicle screw placement guide plate further comprises a puncture needle, which enters the needle channel and passes through the needle channel column into the puncture site of the pedicle. The tail of the puncture needle is provided with a clamping portion, and the needle body of the puncture needle is provided with a scale.

[0014] In a preferred embodiment of the present invention, the puncture needle includes an opening needle and an open-circuit needle. The tip of the opening needle is sharp, and the tip of the open-circuit end is blunt.

[0015] In a preferred embodiment of the present invention, the horizontal column, side column, needle column and diagonal support pillar are integrally formed.

[0016] A method for preparing a pedicle screw placement guide plate comprises the following steps:

[0017] Step 1: Build a vertebral model. Obtain a CT image of the patient's target vertebra and import the image into 3D modeling software to build a 3D model of the target vertebra.

[0018] Step 2: Create a pedicle screw placement guide model. Using 3D modeling software, plan the optimal entry point and direction for the pre-placed screws on the 3D model of the target vertebra using a 4mm diameter cylinder. Then, create a needle track column to surround the cylinder, and sequentially create the transverse column, lateral column, and diagonal brace to obtain the initial model.

[0019] Step 3: Molding and printing: put the initial model and 3D model into the 3D printing software for demolding, and use a 3D printer to print the initial model.

[0020] The beneficial effects of the embodiments of the present invention are as follows: lateral columns are provided at both ends of the transverse column of the pedicle screw placement guide plate in the present invention, the upper ends of the lateral columns partially overlap with the needle channel column, and the lower ends of the lateral columns are in close contact with the contour of the superior articular process bone surface; the needle channel column is used for needle placement, and the bone contact surface of the lower end of the needle channel column is located at the optimal screw insertion point; at the same time, an oblique support column is provided, and the bone contact surface of the oblique support column is located at the outer edge of the vertebral arch isthmus; thus, the pedicle screw placement guide plate adopts a gate-shaped structure to make the guide plate fit with the bilateral bone surface, and the bilateral sides are positioned simultaneously, making the guide plate placement more stable, the positioning more accurate, and the soft tissue peeling surface smaller. With the help of the gate-shaped tree-fork pedicle screw placement guide plate and the matching puncture needle, the surgeon can quickly and accurately place the screws during pedicle fixation surgery, simplifying complex surgery and reducing the cost of equipment. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0022] Figure 1-3 Schematic diagram of the structure of the nail placement guide in various directions according to an embodiment of the present invention;

[0023] Figure 4 This is a schematic structural diagram of a puncture needle according to an embodiment of the present invention;

[0024] Icon: 100- horizontal column; 200- side column; 300- needle channel column; 110- needle channel; 120- horizontal column opening; 400- diagonal support pillar; 500- puncture needle; 510- clamping part; 501- opening needle; 502- open-circuit needle. DETAILED DESCRIPTION

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0026] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort shall fall within the scope of protection of the present invention.

[0027] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not require further definition or explanation in subsequent drawings.

[0028] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" and the like indicate positions or locations based on the positions shown in the accompanying drawings, or the positions or locations in which the inventive product is typically placed when in use. These terms are intended solely to facilitate the description of the present invention and to simplify the description, and are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third," etc., are used solely to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0029] Furthermore, terms such as "horizontal," "vertical," and "overhanging" do not necessarily imply that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0030] In the description of the present invention, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; they may refer to mechanical connections or electrical connections; they may refer to direct connections or indirect connections through an intermediate medium; and they may refer to internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0031] First embodiment

[0032] See Figure 1-3 This embodiment provides a pedicle screw placement guide plate, comprising a transverse column 100, lateral columns 200, and a needle channel column 300. Needle channels 110 are provided at both ends of the transverse column 100. Each needle channel 110 is provided with a lateral column 200 extending vertically downward. Each needle channel 110 is provided with a needle channel column 300 extending diagonally downward. The lateral columns 200 and the needle channel columns 300 share an input end, and the inner lumen of the needle channel column 300 is in communication with the needle channel 110. The pedicle screw placement guide plate further comprises a diagonal support column 400, which extends from the middle of the needle channel column 300 or the lateral column 200. The diagonal support column 400 has an inclination angle with the needle channel column 300 and the lateral column 200, respectively. The output end surfaces of the lateral columns 200, the needle channel column 300, and the diagonal support column 400 are bone-contacting surfaces.

[0033] In this embodiment, side columns 200 are provided at both ends of the transverse column 100, and needle channel columns 300 are attached to the side columns 200, so that the pedicle screw placement guide plate is door-shaped, so that the screw placement guide plate fits with the bilateral bone surfaces, and the bilateral sides are positioned simultaneously, the positioning is more accurate, and the guide plate placement is more stable; the bone fitting surface of the side column 200 fits with the superior articular process of the target vertebra, the bone fitting surface of the needle channel column 300 fits with the optimal screw insertion point of the target vertebra, and the bone fitting surface of the diagonal support column 400 is located at the outer edge of the vertebral arch isthmus, so that the side columns 200, the needle channel column 300 and the diagonal support column 400 are distributed in a tree-branch shape, which makes the guide plate placement more stable and at the same time requires less soft tissue peeling surface.

[0034] More specifically, in this embodiment, the crossbar 100 is a cylindrical structure with a diameter of 10 mm. The top of the crossbar 100 is a needle-threading plane, which is a horizontal plane. Setting the top of the crossbar 100 as a horizontal cutting plane facilitates the stable inverted placement of the guide plate during 3D printing. A needle track 110 is provided at each end of the crossbar 100, and the needle track 110 passes through the needle track column 300 to the optimal nail insertion point. A crossbar opening 120 is provided in the middle of the crossbar 100. The diameter of the crossbar opening 120 is 7 mm. The crossbar opening 120 is a weakened opening, and the strength of the crossbar 100 after the opening is not greatly affected. The crossbar opening 120 is used to cut the crossbar 100 from the weakened opening after the puncture needle is successfully inserted, making it convenient to remove the guide plate without temporarily removing the puncture needle. The advantage of temporarily leaving the puncture needle is that the puncture point can be found quickly.

[0035] The side column 200 in this embodiment is a cylindrical structure with a diameter of 10 mm. The upper end of the side column 200 is connected to the cross column 100, the body partially overlaps with the needle channel column 300, and the lower end conforms to the contour of the superior articular process. The outer side of the side column 200 is also marked with identification. In this embodiment, the left side of the left side column 200 is marked with the patient's name and vertebral segment information, and the right side of the right side column 200 is marked with the hospital identification information. This allows for more intuitive preoperative safety checks and prevents errors.

[0036] In this embodiment, the top of the needle channel column 300 overlaps with the side column 200. The interior of the needle channel column 300 is hollow and connected to the needle channel 110. The bottom of the needle channel column 300 is a bone-fitting surface. The output end of the needle channel column 300 is located at the optimal nail insertion point. Figure 4In this embodiment, a puncture needle 500 is matched. The puncture needle 500 enters from the needle channel 110 and passes through the needle channel column 300 to enter the puncture site of the pedicle. The tail of the puncture needle 500 is provided with a clamping portion 510. The clamping portion 510 is flattened to facilitate clamping and removal. The needle body of the puncture needle 500 is provided with a scale to facilitate the control of the needle insertion depth. The length of the puncture needle 500 is 12-15 cm and the diameter is 3.5 mm. The puncture needle 500 includes an opening needle 501 and an opening needle 502. The tip of the puncture needle 500 is wedge-shaped, wherein the tip of the opening needle 501 is sharp. Even if the needle insertion point is an inclined surface, it can minimize the deviation of the needle channel 110 during puncture; the tip of the opening end is blunt, which effectively reduces the possibility of the opening needle 502 breaking through the side wall of the pedicle cortical bone.

[0037] In this embodiment, the diagonal bracing struts 400 are used to support the outer edge of the isthmus of the vertebral arch. Each lateral column 200 and needle path column 300 is provided with one or more inclined diagonal bracing struts 400, making the nail placement guide more stable and reducing needle placement errors. Furthermore, while enhancing nail placement stability, the diagonal bracing struts 400, lateral columns 200, and needle path columns 300 in this embodiment are designed in a tree-fork-like shape. This eliminates the need for additional support structures during the 3D printing process, improving printing efficiency and the chance of a one-time molding.

[0038] In a preferred embodiment of the present invention, the interiors of the above-mentioned horizontal columns 100, side columns 200 and diagonal support pillars 400 are hollow, and the nail placing guide plate is integrally formed using 3D printing technology, which reduces the weight of the nail placing guide plate itself while ensuring the stability of the nail placing guide plate.

[0039] Accordingly, this embodiment also provides a method for preparing a pedicle screw placement guide plate, which comprises the following steps:

[0040] Step 1: Build a vertebral model. Obtain a CT image of the patient's target vertebra and import the image into 3D modeling software to build a 3D model of the target vertebra. In this embodiment, the slice thickness of the target vertebra CT image is not less than 1.5 mm, and the 3D modeling software used is mimi cs 20.0 software.

[0041] Step 2: Create a pedicle screw placement guide model. In 3D modeling software, use a 4mm diameter cylinder to plan the optimal entry point and direction of the pre-placed screws on the 3D model of the target vertebra. Then, create a needle channel column 300 to surround the cylinder, and then sequentially create a transverse column 100, a lateral column 200, and a diagonal support column 400. Then, combine Boolean operations and plane cutting functions in the software to obtain the initial guide model.

[0042] Step 3: Molding and printing: Import the initial model and 3D model into the 3D printing software for demolding, and use a 3D printer to print the initial model. Finally, import the 3D model of the target vertebra and the initial model of the guide plate into the 3-mat ic software for demolding, and then label the patient's name, vertebral segment, hospital name, etc. on the guide plate side column 200. Export the 3D model of the guide plate and print the model with a 3D printer. In this embodiment, the "Aurora Elfavo" brand printer based on the fused deposition model is selected. Due to the design advantages of the guide plate itself, even using a more primitive fused deposition model 3D printer has a very high one-time molding rate.

[0043] The method of using the pedicle screw placement guide in this embodiment is as follows:

[0044] 1. After the nail placement guide is made, it is sterilized by low-temperature plasma before surgery, and the patient information marked on the guide is checked to be correct before preparing for surgery; the patient information in this embodiment includes but is not limited to the attached Figure 1-3 The hospital name (Yue TCM Bone) and the patient name (Zhang San) shown can be replaced with other information such as the patient's injury site. In this embodiment, the patient information is also printed by a 3D printer.

[0045] 2. During the operation, the superior articular process, the lambdoid ridge and the outer edge of the isthmus of the vertebrae of the target vertebra are exposed. The bone-fitting surface of the prepared screw placement guide is buckled onto the exposed bone surface. Check that the guide is well attached and stably installed.

[0046] 3. Then, insert a 3.5 mm opening needle 501 into the needle channel column 300 through the needle channels 110 on both sides, with a depth of about 0.5 cm into the bone. Use C-arm fluoroscopy in the anteroposterior and lateral positions to verify whether the entry point and direction of the opening needle 501 are correct.

[0047] 4. After confirming that there are no abnormalities, use a larger vascular clamp to clamp the clamping part 510 at the tail of the opening needle 501, rotate and remove the opening needle 501 on one side to facilitate the expansion of the bone canal, and then knock in the opening needle 502 to a depth of about 2 cm. The flat surface of the tip of the opening needle 502 is parallel to the longitudinal line of the spine. The opening needle 501 on the other side is removed in the same way and the opening needle 502 is knocked in to a depth of about 2 cm. Perform C-arm fluoroscopy in the anteroposterior and lateral positions again to check whether the entry point and direction of the opening needle 502 are correct. If it does not break through the medial wall of the pedicle on the anteroposterior view and the Kirschner wire tip is close to or reaches the posterior wall of the vertebral body on the lateral view, it indicates safety.

[0048] 5. After confirming that it is correct, continue to hammer the needle in about 1-2 cm, then cut off the horizontal column 100, pull out the guide plate, and temporarily retain the open-circuit needle 502 to avoid the situation where the bone opening cannot be found when placing the nail.

[0049] 6. Use a larger vascular clamp to hold the clamping area at the tail of the open needle 502, rotate and remove the open needle 502 where the nail is to be placed, and use a probe to measure the depth of the nail channel and the integrity of the four walls in turn. After confirming that there are no abnormalities, use a tap of appropriate size to tap, and then use a probe to detect. If there are no abnormalities, screw in a screw of appropriate specifications.

[0050] 7. Perform C-arm anteroposterior and lateral fluoroscopy again. If there is no abnormality in the screw, the screw placement operation is completed.

[0051] In summary, the preparation method of the present invention can be used to manufacture a bilaterally simultaneously positioned pedicle screw aimer that is well adhered to the target vertebral positioning surface and has a high-precision screw placement channel. The surgeon can perform pedicle screw placement operations accurately and quickly, which not only improves the efficiency of the operation, but also ensures the accuracy and safety of the operation. At the same time, the unique tree-fork layout and door-type frame design of the guide plate in the present invention are not only structurally reasonable and strong, but also not easy to deform, and greatly save 3D printing consumables, shorten printing time, and have an extremely high one-time molding rate during 3D printing. The use of an integrated guide plate with bilateral simultaneous positioning has a small bone contact area, does not require a large area of ​​soft tissue stripping, and has stable attachment, which effectively guarantees the accuracy of screw placement.

[0052] This specification describes examples of embodiments of the present invention and is not intended to illustrate and describe all possible forms of the invention. It should be understood that the embodiments described in this specification may be implemented in a variety of alternative forms. The figures need not be drawn to scale; some features may be enlarged or reduced to show details of particular components. The specific structural and functional details disclosed should not be interpreted as limiting, but merely as a representative basis for teaching those skilled in the art to implement the invention in various forms. It should be understood by those skilled in the art that the multiple features illustrated and described with reference to any one of the figures may be combined with features illustrated in one or more other figures to form embodiments that are not explicitly illustrated or described. The illustrated combined features provide representative embodiments for typical applications. However, various combinations and variations of features consistent with the teachings of the present invention may be used for specific applications or implementations as needed.

[0053] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A pedicle screw placement guide plate, characterized in that: It includes a horizontal column, a side column and a needle track column. The two ends of the horizontal column are provided with needle tracks. Each needle track is vertically extended downward and provided with the side column. Each needle track is obliquely extended downward and provided with the needle track column. The side column and the needle track column share an input end, and the inner cavity of the needle track column is connected with the needle track. Side columns are provided at both ends of the transverse column, and needle track columns are attached to the side columns, so that the pedicle screw guide plate is gate-shaped. The screw guide plate fits the bone surface on both sides and is positioned on both sides simultaneously. The bone-fitting surface of the side columns fits the superior articular process of the target vertebra, the bone-fitting surface of the needle track column fits the optimal screw insertion point of the target vertebra, and the bone-fitting surface of the diagonal support column is located at the outer edge of the vertebral isthmus, so that the side columns, needle track column and diagonal support column are distributed in a tree-branch shape. The pedicle screw placement guide plate further includes an oblique support column, which extends from the middle of the needle track column or the side column, and has an inclination angle with the needle track column and the side column respectively; the interiors of the transverse column, the side column and the oblique support column are hollow; The output end surfaces of the side columns, the needle track columns and the diagonal support pillars are bone-fitting surfaces; The pedicle screw guide plate also includes a puncture needle, which enters the needle channel and passes through the needle channel column to enter the puncture site of the pedicle. The tail of the puncture needle is provided with a clamping portion, and the needle body of the puncture needle is provided with a scale. The puncture needle includes an opening needle and an opening needle. The tip of the opening needle is sharp, and the tip of the opening end is blunt. The top of the horizontal column is a flat surface, and the bottom surface of the horizontal column is a bone-fitting surface. The preparation method of the pedicle screw placement guide plate includes: Step 1: Establish a vertebral model by obtaining a CT image of the patient's target vertebra and importing the image into 3D modeling software to establish a 3D model of the target vertebra; Step 2: Establish a pedicle screw placement guide model. In the 3D modeling software, a 4 mm diameter cylinder is used to plan the optimal entry point and direction of the pre-placed screws on the 3D model of the target vertebra. Then, a needle column is built to surround the cylinder, and the horizontal column, lateral column, and diagonal support column are sequentially established to obtain the initial model. Step 3: Molding and printing: import the initial model and the 3D model into the 3D printing software for demolding, and use a 3D printer to print the initial model.

2. The pedicle screw placement guide according to claim 1, characterized in that: A horizontal column opening is provided in the middle of the horizontal column.

3. The pedicle screw placement guide according to claim 1, characterized in that: The transverse column, the side column, the needle column and the diagonal support pillar are integrally formed.

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