Spinal pedicle screw implantation surgery navigation template and preparation and use method thereof

Abstract

A spinal pedicle screw implantation surgery navigation template and its preparation and use method, wherein the spinal pedicle screw implantation surgery navigation template comprises a positioning navigation body and a locking piece having a fitting plate, a locking platform and a positioning guide member, wherein the fitting surface of the fitting plate is used to fit with the surface of the vertebral plate on one side of the spine where the pedicle screw of the patient who needs to undergo pedicle screw implantation surgery is implanted, the locking platform is arranged in the middle of the working surface of the fitting plate and is provided with a fixing hole, the positioning guide member is arranged at the edge of one side of the working surface and is provided with a guiding channel, the guiding channel is used for implanting the pedicle screw to be implanted on the pedicle of the patient's spine, and the locking piece is used to fix the positioning navigation body on the vertebral plate of the patient's spine where the pedicle screw to be implanted is implanted through the fixing hole. The present invention can fix the entire positioning navigation body on the vertebral plate of the patient's spine where the pedicle screw to be implanted is implanted, and the surgery can be performed by only fixing it on the unilateral vertebral plate of the patient's spine, with less surgical dissection, smaller incision, and better medical effect.

Description

Technical Field

[0001] The present invention relates to a navigation template and a preparation and use method thereof, and in particular to a spinal pedicle screw implantation surgery navigation template and a preparation and use method thereof, belonging to the technical field of manufacturing of medical devices and their preparation and use methods. Background Art

[0002] Spinal pedicle screw implantation surgery is a spinal fixation procedure, which is mainly used for spinal fixation of patients with intervertebral disc herniation and segmental spinal instability, spondylolisthesis, spinal fracture, spinal stenosis and infectious diseases such as spinal tuberculosis.

[0003] In clinical practice, for some complex pedicle screw implantation and reconstruction surgeries, such as the occipital-cervical junction, upper cervical spine, cervical-thoracic junction, and severe spinal deformity areas, pedicle screw implantation is often difficult due to the complex anatomical structure of the lesion area, anatomical structure variation, and difficulty in intraoperative positioning. Screw placement errors are prone to occur during the operation, resulting in poor pedicle screw implantation depth and angle, and easy perforation of the pedicle side wall. It can also damage the nerves and blood vessels in the surgical area, causing serious complications and even endangering the patient's life.

[0004] Although intraoperative C-arm or CT image-guided navigation technology is also used in complex spinal reconstruction surgery during pedicle screw placement, it is not the best choice because intraoperative image navigation equipment is expensive, it takes a lot of time to locate the reference points during use, and repeated fluoroscopy during surgery will greatly increase the radiation exposure of the surgeon and the patient. There is also the risk of incorrect screw placement due to inaccurate positioning of anatomical reference points.

[0005] For this purpose, a pedicle screw navigation template (English: Pedicle Screw Guided Template, English abbreviation: PSGT) has appeared in the prior art.

[0006] The existing pedicle screw navigation template is an individualized guide tool that is complementary to the posterior bony structure of the target vertebra and has a screw insertion guide channel and is designed and manufactured based on preoperative patient imaging data using 3D reconstruction technology and rapid prototyping technology.

[0007] However, the pedicle screw navigation template in the prior art still has some shortcomings, including:

[0008] The accuracy is not enough, and the position of the navigation template is prone to shift during use; the reason is that although the pedicle screw navigation template in the prior art uses technologies and measures such as preoperative thin-layer CT scanning, use of a highly accurate 3D printer, careful exposure of the posterior bone structure during surgery, and ensuring the close fit of the navigation template with the posterior accessory structure of the vertebral body during surgery to reduce the error in the application of the navigation template, some errors are still inevitably generated during the collection, three-dimensional reconstruction and 3D printing of imaging data, and there is no dedicated fixing tool for the fit between the existing navigation template and the posterior accessory bone structure of the vertebral body. Therefore, the position of the navigation template during surgery will still be offset;

[0009] Secondly, the structure is not stable enough and is easily damaged, resulting in navigation failure. The reason is that the 3D printed pedicle screw navigation template currently used in clinical practice is made of photosensitive resin material. Due to the characteristics of the photosensitive resin material and the defects in the structural design, the existing pedicle screw navigation template is relatively brittle. If the operation is not careful during the operation, it will cause the template to break and the navigation hole to fail, thus leading to navigation failure.

[0010] In addition, the 3D printed pedicle screw navigation template currently used in clinical practice must be used after the soft tissue on both sides of the posterior spine of the patient's pedicle screw implantation site is completely stripped away, and the accessory structures on both sides of the posterior spine, including the spinous process and lamina structure, are fully exposed. Only then can the pedicle screw navigation template fit closely with the local bony structure to ensure the accuracy of the navigation template. As a result, the paraspinal muscle and ligament structure complex at the posterior spine is excessively stripped away, resulting in the loss of the dynamic stability function of the spine provided by the soft tissue structure at the posterior spine, which can easily lead to complications such as postoperative axial pain. Summary of the invention

[0011] In order to overcome the shortcomings of the prior art, the present invention specifically provides a new type of spinal pedicle screw implantation surgical navigation template and its preparation and use method, so as to accurately position and accurately navigate the navigation template during the spinal pedicle screw implantation surgery, effectively avoid the position drift of the navigation template during the operation, ensure the accuracy of pedicle screw implantation, avoid the stripping of the patient's interspinal ligament, supraspinal ligament and other posterior spinal ligament structure complexes during the operation, reduce surgical trauma, preserve the integrity and biomechanical stability of the posterior spinal structure, and provide better medical services for patients.

[0012] To achieve the above-mentioned purpose, the present invention first provides a navigation template for spinal pedicle screw implantation surgery, and its technical solution includes:

[0013] A spinal pedicle screw implantation surgery navigation template, used for positioning navigation of human spinal pedicle screw implantation surgery, comprising:

[0014] Positioning navigation body and locking member;

[0015] The positioning and navigation body comprises a laminating plate, a locking platform and a positioning and guiding member;

[0016] The fitting plate comprises a fitting surface and a working surface on a side opposite to the fitting surface, wherein the fitting surface is used to fit with the surface of the vertebral plate on the side of the spine where the pedicle screw is implanted in the patient who needs to undergo pedicle screw implantation surgery;

[0017] The locking platform is arranged in the middle of the working surface, and a fixing hole penetrating the locking platform and the laminating plate and corresponding to the vertebral plate is arranged in the middle of the locking platform;

[0018] The positioning guide member is arranged at the edge of one side of the working surface of the bonding plate, and the positioning guide member is also provided with a guide channel which penetrates the positioning guide member and the bonding plate and faces the implantation position of the pedicle screw to be implanted in the patient, the guide channel is used for implanting the pedicle screw to be implanted on the pedicle of the spine of the patient, and the central axis of the guide channel coincides with the implantation direction center line of the pedicle screw to be implanted;

[0019] The locking piece is used to fix the positioning navigation body on the vertebral plate of the spine of the patient where the pedicle screw is to be implanted through the fixing hole.

[0020] As a further optimization:

[0021] The spinal pedicle screw implantation surgery navigation template also includes a reinforcement block in the positioning navigation body. The reinforcement block is arranged on the working surface, and the two ends of the reinforcement block are respectively connected to the outer sides of the locking platform and the positioning guide component.

[0022] Optionally, the locking member is a Kirschner wire, and the needle diameter of the Kirschner wire matches the hole diameter of the fixing hole.

[0023] Optionally, the Kirschner wire has a needle diameter of 1.0 mm.

[0024] Optionally, the positioning guide member is a semicircular cylinder or a frustum, and the guide channel provided on the positioning guide member is a semicircular through groove, and the opening of the through groove faces away from the bonding plate.

[0025] Furthermore, the cross-sectional radius of the semicircular through groove matches the outer radius of the opener and the scout required to be used in the pedicle screw implantation process of the human spine pedicle screw implantation surgery.

[0026] Optionally, the positioning and navigation body is made of photosensitive resin.

[0027] Furthermore, the positioning and navigation body is an integrated structural component made of photosensitive resin by 3D printing.

[0028] Furthermore, the present invention also provides a method for preparing the spinal pedicle screw implantation surgery navigation template, comprising the following steps:

[0029] Performing a thin-layer CT scan on the spine of a patient who needs to undergo a spinal pedicle screw implantation operation at the pedicle screw implantation location to obtain CT scan data of the spinal bone structure;

[0030] Importing the bone structure CT scan data into medical image processing software, selecting the bone structure image data of one side of the spine where pedicle screws need to be implanted and performing three-dimensional reconstruction, obtaining the three-dimensional structure of the pedicle of the spine and a three-dimensional fitting surface graphic that can complement the bone structure of the outer surface of the vertebral plate of the spine, and establishing a working surface on the three-dimensional fitting surface graphic to form a fitting plate;

[0031] A locking platform capable of fitting and fixing the fitting plate to the outer surface of the spinal lamina through a Kirschner wire and a fixing hole adapted to the Kirschner wire are arranged on the working surface of the fitting plate, and a positioning guide component capable of introducing the pedicle screw into the pedicle of the spine and a guiding channel thereof are arranged on the fitting plate, or a reinforcing block connecting the locking platform and the positioning guide component is further established on the working surface to form a three-dimensional digital model of the positioning navigation body of the spinal pedicle screw implantation surgery navigation template;

[0032] The three-dimensional digital model is input into a 3D printer for printing to obtain a 3D print of a positioning navigation body of a personalized spinal pedicle screw implantation surgery navigation template for the patient's pedicle screw implantation location point; the 3D print is processed according to medical requirements and equipped with the Kirschner wire to obtain the spinal pedicle screw implantation surgery navigation template.

[0033] Furthermore, the present invention also provides a method for using the spinal pedicle screw implantation surgery navigation template, comprising the following steps:

[0034] The skin and soft tissue at the pedicle screw implantation point of the patient who needs pedicle screw implantation is cut open to expose the spinal lamina on the corresponding side of the pedicle screw implantation point;

[0035] A personalized spinal pedicle screw implantation surgical navigation template made according to the bone structure of the outer surface of the spinal lamina at the pedicle screw implantation point of the patient is attached to the outer side of the lamina of the spine corresponding to the pedicle screw implantation point of the patient, and the positioning navigation body is fixed to the lamina of the spine with a Kirschner wire matching the fixing hole of the positioning navigation body;

[0036] The pedicle screw is implanted into the pedicle of the spine of the patient through the guide channel on the positioning navigation body to complete the implantation of the pedicle screw;

[0037] The Kirschner wire is pulled out from the vertebral plate of the spine, and then the positioning navigation body is removed from the vertebral plate of the patient's spine, thereby completing the use of the spinal pedicle screw implantation surgery navigation template.

[0038] Compared with the prior art, the present invention has outstanding beneficial effects and significant improvements in that:

[0039] 1) The spinal pedicle screw implantation surgery navigation template for positioning navigation of human spinal pedicle screw implantation surgery provided by the present invention comprises a positioning navigation body and a locking piece, wherein the positioning navigation body comprises a fitting plate, a locking platform and a positioning guide member, the fitting plate has a fitting surface and a working surface opposite to the fitting surface, the fitting surface is used to fit with the surface of the vertebral plate on one side of the spine where the pedicle screw of the patient who needs to undergo pedicle screw implantation surgery is implanted, the locking platform is arranged in the middle of the working surface, and a fixing hole penetrating the locking platform and the fitting plate and corresponding to the vertebral plate is provided in the middle thereof, the positioning guide member is arranged at the edge of one side of the working surface, and a guide channel penetrating the positioning guide member and its fitting plate and facing the implantation position point of the pedicle screw to be implanted in the patient is also provided, the guide channel is used to implant the pedicle screw to be implanted on the pedicle of the patient's spine, and the central axis of the guide channel coincides with the implantation direction center line of the pedicle screw to be implanted, and the locking piece is used to fix the positioning navigation body on the vertebral plate of the spine where the pedicle screw to be implanted is implanted in the patient through the fixing hole;

[0040] 2) The spinal pedicle screw implantation surgical navigation template provided by the present invention overcomes the shortcomings of the prior art. The entire positioning navigation body can be fixed on the vertebral plate of the patient's spine where the pedicle screw is to be implanted through a locking piece, and no additional surgical instruments are required to fix the navigation template during the operation, thereby effectively avoiding the position drift of the navigation template during the operation, ensuring the precise positioning and accurate navigation of the navigation template during the spinal pedicle screw implantation operation, and providing a guarantee for the precise implantation of the pedicle screw;

[0041] 3) The spinal pedicle screw implantation surgery navigation template provided by the present invention is different from the existing navigation template that needs to span the two sides of the patient's spine vertebral plate, and only needs to be fixed on a single side of the patient's spine vertebral plate to perform the surgery, thereby avoiding the stripping of the patient's interspinous ligament, supraspinous ligament and other posterior spinal ligament structure complex during the operation, reducing surgical trauma, and being able to preserve the integrity and biomechanical stability of the posterior spinal structure, thereby providing better medical services for patients;

[0042] 4) The spinal pedicle screw implantation surgery navigation template provided by the present invention has a fixing hole and a guide channel respectively arranged on a locking platform and a positioning guide member thereof, thereby providing sufficient mechanical strength for the fixing hole and the guide channel and the entire positioning navigation body, making them not easily damaged during the operation, and ensuring the smooth completion of the operation;

[0043] 5) The spinal pedicle screw implantation surgical navigation template provided by the present invention is extremely novel and unique in concept. Compared with the traditional pedicle screw navigation template, it is small in size and easy to adjust its position during operation. It requires a small space for the patient to expose the wound during the operation, and can achieve minimally invasive surgery. Compared with the existing technology, it has outstanding substantive characteristics and significant progress, and is extremely valuable for promotion and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to more clearly illustrate the technical solution of the present invention, the following briefly introduces the drawings required for use in the embodiments of the present invention.

[0045] Obviously:

[0046] The drawings described below are only drawings of some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work, but these other drawings also belong to the drawings required for use in the embodiments of the present invention.

[0047] Figure 1 A schematic diagram of the three-dimensional structure of a navigation template for spinal pedicle screw implantation surgery provided by an embodiment of the present invention;

[0048] Figure 2 A schematic diagram of the three-dimensional structure of another spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention;

[0049] Figure 3 A schematic diagram of the working state of a spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention;

[0050] Figure 4 A schematic diagram of the working state of another spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention.

[0051] In the figure:

[0052] 10-Laminae;

[0053] 100-positioning navigation body, 110-fitting plate, 111-fitting surface, 112-working surface, 120-locking platform, 121-fixing hole, 130-positioning guide member, 131-guide channel, 140-reinforcement block;

[0054] 200-Locking piece. DETAILED DESCRIPTION

[0055] In order to make the purpose, technical solution, beneficial effects and significant progress of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the drawings provided in the embodiments of the present invention. Obviously, all the described embodiments are only partial embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0056] It should be noted that:

[0057] The term "comprising" and any variations thereof in the specification and claims of the present invention and the drawings of the embodiments of the present invention are intended to cover non-exclusive inclusions. For example, a process, method, system, product or apparatus comprising a series of steps or units is not limited to the listed steps or units, but may optionally include unlisted steps or units, or may optionally include other steps or units inherent to these processes, methods, products or apparatuses.

[0058] What needs to be understood is:

[0059] In the description of the embodiments of the present invention, terms such as "upper" and "lower" that indicate orientation or position are only based on the orientation or position relationship shown in the drawings of the embodiments of the present invention. They are for the convenience of describing the embodiments of the present invention and simplifying the explanation, rather than indicating or implying a specific orientation, specific orientation structure and operation that the device or element described must have. Therefore, they cannot be understood as limiting the present invention.

[0060] In the present invention, unless otherwise clearly stipulated and limited, the terms such as "installation", "setting", "connection" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, a movable connection, or an integrated connection. It can be a direct connection or an indirect connection through an intermediate medium. It can be the internal connection of two elements or the interaction relationship between two elements. Unless otherwise clearly defined, ordinary technicians in this field can understand the specific meanings of the above terms in the present invention according to the specific circumstances.

[0061] It should also be noted that the following specific embodiments may be combined with each other, and the same or similar concepts or processes therein may not be repeated in some embodiments.

[0062] The technical solution of the present invention is described in detail below with specific embodiments.

[0063] Example 1

[0064] This embodiment provides a spinal pedicle screw implantation surgery navigation template used for positioning navigation in human spinal pedicle screw implantation surgery.

[0065] like Figure 1 A schematic diagram of the three-dimensional structure of a spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention, Figure 2 A schematic diagram of the three-dimensional structure of another spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention, and Figure 3 A schematic diagram of a spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention, Figure 4 A working state diagram of another spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention is shown as follows:

[0066] A spinal pedicle screw implantation surgery navigation template, comprising:

[0067] Positioning the navigation body 100 and the locking member 200;

[0068] The positioning navigation body 100 includes a bonding plate 110, a locking platform 120 and a positioning guide member 130;

[0069] The fitting plate 110 includes a fitting surface 111 and a working surface 112 on a side opposite to the fitting surface 111. The fitting surface 111 is used to fit with the surface of the vertebral plate 10 on a side of the spine (not shown in the figure) where the pedicle screw (not shown in the figure) of the patient who needs to undergo pedicle screw implantation surgery is implanted;

[0070] The locking platform 120 is disposed in the middle of the working surface 112, and a fixing hole 121 is disposed in the middle of the locking platform 120, which penetrates the locking platform 120 and the laminating plate 110 and corresponds to the vertebral plate 10;

[0071] The positioning guide member 130 is arranged at one side edge of the working surface 112 of the bonding plate 110, and the positioning guide member 130 is also provided with a guide channel 131 that penetrates the positioning guide member 130 and the bonding plate 110 and faces the implantation position of the pedicle screw (not shown in the figure) to be implanted in the patient, and the guide channel 131 is used for implanting the pedicle screw (not shown in the figure) to be implanted on the pedicle (not shown in the figure) of the patient's spine (not shown in the figure), and the central axis of the guide channel 131 coincides with the implantation direction center line of the pedicle screw (not shown in the figure) to be implanted;

[0072] The locking member 200 is used to fix the positioning navigation body 100 on the vertebral plate 10 of the patient's spine (not shown in the figure) where the pedicle screws (not shown in the figure) are to be implanted through the fixing holes 121 .

[0073] From the above description, we can see that:

[0074] The present embodiment provides a spinal pedicle screw implantation surgery navigation template for positioning navigation of human spinal pedicle screw implantation surgery, which includes a positioning navigation body and a locking piece, wherein the positioning navigation body includes a fitting plate, a locking platform and a positioning guide member, wherein the fitting surface in the fitting plate is used to fit with the surface of the vertebral plate on one side of the spine where the pedicle screw of the patient who needs to undergo pedicle screw implantation surgery is implanted, the locking platform is arranged in the middle of the working surface, and is provided with a fixing hole that penetrates the locking platform and the fitting plate and corresponds to the vertebral plate, the positioning guide member is arranged at the edge of one side of the working surface, and is provided with a guiding channel that penetrates the positioning guide member and its fitting plate and is directly facing the implantation position point of the patient's pedicle screw to be implanted, and the locking piece can fix the positioning navigation body on the vertebral plate of the patient's spine where the pedicle screw to be implanted is implanted through the fixing hole;

[0075] Due to the spinal pedicle screw implantation surgical navigation template provided in this embodiment, the entire positioning navigation body can be fixed on the vertebral plate of the patient's spine where the pedicle screw is to be implanted through the locking piece, and no additional surgical instruments are required to fix the navigation template during the operation, thereby effectively avoiding the position drift of the navigation template during the operation, thereby ensuring the accurate positioning and precise navigation of the navigation template during the spinal pedicle screw implantation operation, and providing a guarantee for the accurate implantation of the pedicle screw;

[0076] In addition, unlike the existing navigation template that must span across the two vertebral plates of the patient's spine, the spinal pedicle screw implantation surgery navigation template provided in this embodiment only needs to be fixed on a single vertebral plate of the patient's spine to perform the surgery. Therefore, it is possible to avoid the peeling of the posterior spinal ligament structure complex such as the interspinous ligament and supraspinous ligament of the patient during the operation, thereby reducing the trauma of the operation, and being able to preserve the integrity and biomechanical stability of the posterior spinal structure, thereby providing better medical services for patients.

[0077] At the same time, since the spinal pedicle screw implantation surgery navigation template provided in this embodiment has its fixing holes and guide channels respectively arranged on the locking platform and its positioning guide member, sufficient mechanical strength can be provided for the fixing holes and guide channels and their entire positioning navigation body, making them less susceptible to damage during the surgery, thereby ensuring the smooth completion of the surgery;

[0078] It can be seen that the spinal pedicle screw implantation surgery navigation template provided in this embodiment is extremely novel and unique in concept. Compared with the traditional pedicle screw navigation template, it is small in size, easy to adjust its position during operation, requires a small space for exposing the patient's intraoperative incision, and can achieve minimally invasive surgery. Therefore, compared with the existing technology, it has outstanding substantive characteristics and significant progress, and is extremely valuable for promotion and application.

[0079] As a further optimization, Figures 1 to 4 It can also be seen that in this embodiment:

[0080] The positioning and navigation body 100 further includes a reinforcement block 140 , which is disposed on the working surface 112 , and two ends of the reinforcement block 140 are respectively connected to the outer sides of the locking platform 120 and the positioning and guiding member 130 .

[0081] Obviously, by adding a reinforcement block to the positioning navigation body and connecting the locking platform and the positioning guide component through the reinforcement block, thereby forming an integral structure with the bonding plate, the mechanical strength of the positioning navigation body can be greatly improved, thereby ensuring that it is not damaged during the operation and ensuring the smooth completion of the operation.

[0082] Optionally, in this embodiment, the locking member 200 is a Kirschner wire, and the needle diameter of the Kirschner wire matches the hole diameter of the fixing hole 121, thereby ensuring that the Kirschner wire can smoothly pass through the fixing hole to fix the positioning navigation body to the patient's spinal lamina.

[0083] Clinical practice has shown that a Kirschner wire with a needle diameter of 1.0 mm can be used to implement the present invention.

[0084] Of course, the Kirschner wire used as a locking member can have other needle diameters according to clinical needs. When using Kirschner wires of other needle diameters, the diameter of the fixing hole in the positioning navigation body should also be adaptively adjusted when the positioning navigation body is manufactured.

[0085] As an optional implementation, Figure 1 and Figure 2 As shown, in this embodiment:

[0086] The positioning guide member 130 is a semicircular cylinder or a truncated cone, and the guide channel 131 provided on the positioning guide member 130 is a semicircular through groove, and the opening of the through groove faces away from the bonding plate 110 .

[0087] It can be seen that the positioning and guiding component composed of a semicircular cylinder or a truncated cone has quite good mechanical strength and openness, and its opening is facing away from the through groove of the bonding plate, which not only has good positioning and guiding properties, but also its open side can leave space for the use of other instruments during the operation, thereby facilitating the surgical operation.

[0088] As an optimized option, in this embodiment:

[0089] The cross-sectional radius of the semicircular through groove matches the outer radius of the opener and the scout required to be used in the implantation process of the pedicle screws (not shown in the figure) of the human spine pedicle screw implantation surgery.

[0090] This is designed because:

[0091] If the cross-sectional radius of the through slot is smaller than the outer radius of the opener or the scout, the screw path preparation during the pedicle screw implantation process cannot be successfully completed. If the cross-sectional radius of the through slot is too large, the guiding error will become larger, which is not conducive to accurately controlling the screw path direction of the pedicle screw.

[0092] Optionally, in this embodiment, the positioning navigation body 100 is made of photosensitive resin.

[0093] Of course, with the development of material science, the positioning navigation body in this embodiment can also be made of other materials that meet medical requirements.

[0094] As a preferred implementation, the positioning navigation body 100 in this embodiment is an integrated structural component made of photosensitive resin by 3D printing.

[0095] Example 2

[0096] This embodiment provides a method for preparing the spinal pedicle screw implantation surgery navigation template described in the above-mentioned embodiment 1.

[0097] like Figure 3 A schematic diagram of a spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention, Figure 4 A working state diagram of another spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention is shown in a schematic diagram of a spinal pedicle screw implantation surgery navigation template. A method for preparing a spinal pedicle screw implantation surgery navigation template comprises the following steps:

[0098] Performing a thin-layer CT scan on the spine of a patient who needs a pedicle screw implantation operation at the pedicle screw implantation location to obtain CT scan data of the spinal bone structure;

[0099] Import the above-mentioned bone structure CT scan data into medical image processing software, select the bone structure image data of one side of the spine where pedicle screws need to be implanted and perform three-dimensional reconstruction, obtain the three-dimensional structure of the pedicle of the spine and the three-dimensional bonding surface 111 graphic that can complement the outer surface bone structure of the vertebral plate 10 of the spine, and establish a working surface 112 on the three-dimensional bonding surface 111 graphic to form a bonding plate 110;

[0100] A locking platform 120 and a fixing hole 121 adapted to the Kirschner wire (not shown in the figure) are provided on the working surface 112 of the bonding plate 110, which can bond and fix the bonding plate 110 to the outer surface of the patient's spinal lamina 10 through a Kirschner wire (not shown in the figure), and a positioning guide member 130 and a guide channel 131 are provided on the bonding plate 110, which can guide the pedicle screw into the pedicle of the patient's spine, or a reinforcing block 140 connecting the locking platform and the positioning guide member is further established on the working surface, so as to form a three-dimensional digital model of the positioning navigation body 100 of the spinal pedicle screw implantation surgery navigation template;

[0101] The three-dimensional digital model is input into a 3D printer for printing to obtain a 3D print of a personalized spinal pedicle screw implantation surgery navigation template and its positioning navigation body for the patient's pedicle screw implantation location point. The 3D print is then processed according to medical requirements and equipped with a suitable Kirschner wire to obtain the spinal pedicle screw implantation surgery navigation template required in this embodiment.

[0102] From the above description, we can see that:

[0103] The preparation method of the spinal pedicle screw implantation surgery navigation template provided in this embodiment is simple, convenient and technically mature. Compared with the existing technology, its main difference lies in that, in the process of forming the three-dimensional digital model of the positioning navigation body, it is necessary to set a locking table and its fixing hole adapted to the Kirschner wire, as well as a positioning guide component and its guide channel at a specific position on the working surface of the bonding plate according to the patient's specific vertebral plate structure and the pedicle screw implantation position point, so as to obtain a personalized spinal pedicle screw implantation surgery navigation template that meets the patient's needs, so as to complete the corresponding pedicle screw implantation surgery.

[0104] Example 3

[0105] This embodiment provides a method for using the spinal pedicle screw implantation surgery navigation template described in the above-mentioned embodiment 1.

[0106] like Figure 3 A schematic diagram of a spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention, Figure 4 Another spinal pedicle screw implantation surgery navigation template provided by an embodiment of the present invention is shown in a schematic diagram of its working state. A method for using the spinal pedicle screw implantation surgery navigation template described in the above embodiment 1 comprises the following steps:

[0107] The skin and soft tissue at the pedicle screw implantation point of the patient who needs pedicle screw implantation is cut open to expose the spinal lamina 10 on the corresponding side of the pedicle screw implantation point;

[0108] Then, if Figure 3 and Figure 4As shown, the fitting surface 111 of the positioning navigation body 100 of the personalized spinal pedicle screw implantation surgical navigation template made according to the bony structure of the outer surface of the spinal lamina at the pedicle screw implantation point of the patient is fitted to the outer side of the spinal lamina 10 corresponding to the pedicle screw implantation point of the patient, and the positioning navigation body 100 is fixed on the spinal lamina 10 of the patient with a Kirschner wire matching the fixing hole of the positioning navigation body 100;

[0109] The pedicle screw (not shown in the figure) is implanted into the pedicle of the spine of the patient through the guide channel 131 on the positioning navigation body 100 to complete the implantation of the pedicle screw;

[0110] The Kirschner wire (not shown) is pulled out from the vertebral plate 10 of the patient's spine, and then the positioning navigation body 100 is removed from the vertebral plate 10 of the patient's spine, thereby completing the use of the spinal pedicle screw implantation surgery navigation template described in Example 1.

[0111] From the above description, we can see that:

[0112] The spinal pedicle screw implantation surgery navigation template provided in Example 1 is simple to use. Unlike the navigation template in the prior art that must be placed across the two sides of the patient's spine vertebral laminae before use, the spinal pedicle screw implantation surgery navigation template provided in Example 1 only needs to be fixed on a single side of the patient's spine vertebral laminae during use, thereby avoiding the detachment of the patient's interspinous ligament, supraspinous ligament and other posterior spinal ligament structure complexes during surgery, thereby reducing the trauma of the surgery and preserving the integrity and biomechanical stability of the posterior spinal structure. In addition, the incision space that the patient needs to expose during the operation is small, so minimally invasive surgery can be achieved, thereby providing patients with better medical services.

[0113] In summary, we can see that:

[0114] Firstly, the present invention overcomes the shortcomings of the prior art by using a positioning navigation body and a locking member having a bonding plate, a locking platform and a positioning guide member, and constructs a novel navigation template for spinal pedicle screw implantation surgery, which can be used for positioning navigation of spinal pedicle screw implantation surgery in the human body;

[0115] Secondly, the spinal pedicle screw implantation surgery navigation template provided by the present invention is different from the existing navigation template that needs to span the two sides of the patient's spine vertebral plate, and only needs to be fixed on a single side of the patient's spine vertebral plate to perform the surgery, thereby avoiding the stripping of the patient's interspinous ligament, supraspinous ligament and other posterior spinal ligament structure complex during the operation, reducing surgical trauma and retaining the integrity and biomechanical stability of the posterior spinal structure;

[0116] Again, the spinal pedicle screw implantation surgical navigation template provided by the present invention has a fixing hole and a guide channel respectively arranged on a locking platform and a positioning guide component, so that the fixing hole and the guide channel and the entire positioning navigation body have sufficient mechanical strength, are not easily damaged during the operation, and can ensure the smooth completion of the operation. The concept is extremely novel and unique. Compared with the traditional pedicle screw navigation template, it is small in size, easy to operate, and easy to adjust the position. It requires a small space for the patient to expose the wound during the operation, and can realize minimally invasive surgery, providing patients with better medical services and obtaining better medical results. Compared with the existing technology, it has outstanding substantial characteristics and significant progress, and is extremely valuable for promotion and application.

[0117] In the description of the above manual:

[0118] The terms "this embodiment", "an embodiment of the present invention", "as shown in", "further", etc., mean that the specific features, structures, materials or characteristics described in the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example, and the specific features, structures, materials or characteristics described may be combined or combined in any one or more embodiments or examples in a suitable manner;

[0119] In addition, under the premise that no contradiction occurs, a person of ordinary skill in the art may combine or combine different embodiments or examples and features of different embodiments or examples described in this specification.

[0120] Finally, it should be noted that:

[0121] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents, and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. The non-essential improvements, adjustments or replacements made by those skilled in the art based on the contents of this specification are all within the scope of protection required by the present invention.

Claims

1. A surgical navigation template for pedicle screw implantation in the spine, used for positioning and navigation of pedicle screw implantation in the human spine, which can be performed by simply fixing it on a unilateral vertebral plate of the patient's spine, thereby avoiding the stripping of the posterior ligament structure complex of the patient's spine during the operation and reducing surgical trauma, characterized in that: include: Positioning navigation body and locking member; The positioning and navigation body comprises a laminating plate, a locking platform and a positioning and guiding member; The fitting plate comprises a fitting surface and a working surface on a side opposite to the fitting surface, wherein the fitting surface is used to fit with the surface of the vertebral plate on the side of the spine where the pedicle screw is implanted in the patient who needs to undergo pedicle screw implantation surgery; The locking platform is arranged in the middle of the working surface, and a fixing hole penetrating the locking platform and the laminating plate and corresponding to the vertebral plate is arranged in the middle of the locking platform; The positioning guide member is arranged at the edge of one side of the working surface of the bonding plate, and the positioning guide member is also provided with a guide channel which penetrates the positioning guide member and the bonding plate and faces the implantation position of the pedicle screw to be implanted in the patient, the guide channel is used for implanting the pedicle screw to be implanted on the pedicle of the spine of the patient, and the central axis of the guide channel coincides with the implantation direction center line of the pedicle screw to be implanted; The locking member is used to fix the positioning navigation body to the vertebral plate of the spine of the patient where the pedicle screw is to be implanted through the fixing hole; The positioning and navigation body further includes a reinforcement block, which is arranged on the working surface, and the two ends of the reinforcement block are respectively connected to the outer sides of the locking platform and the positioning and guiding member; The positioning guide member is a semicircular cylinder or a semicircular truncated cone, and the guide channel arranged on the positioning guide member is a semicircular through groove, and the opening of the through groove faces away from the bonding plate: The positioning navigation body is an integrated structural part made of photosensitive resin by 3D printing.

2. The spinal pedicle screw implantation surgery navigation template according to claim 1, characterized in that: The locking piece is a Kirschner wire, and the needle diameter of the Kirschner wire matches the hole diameter of the fixing hole.

3. The spinal pedicle screw implantation surgery navigation template as claimed in claim 2, characterized in that: The needle diameter of the Kirschner wire is 1.0 mm.

4. The spinal pedicle screw implantation surgery navigation template according to claim 1, characterized in that: The cross-sectional radius of the semicircular through groove matches the outer radius of the opener and the scout required to be used in the pedicle screw implantation process of the human spine pedicle screw implantation surgery.

5. A method for preparing a navigation template for spinal pedicle screw implantation surgery as described in any one of claims 1 to 4, characterized in that: The steps include: Performing a thin-layer CT scan on the spine of a patient who needs to undergo a spinal pedicle screw implantation operation at the pedicle screw implantation location to obtain CT scan data of the spinal bone structure; Importing the bone structure CT scan data into medical image processing software, selecting the bone structure image data of one side of the spine where pedicle screws need to be implanted and performing three-dimensional reconstruction, obtaining the three-dimensional structure of the pedicle of the spine and a three-dimensional fitting surface graphic that can complement the bone structure of the outer surface of the vertebral plate of the spine, and establishing a working surface on the three-dimensional fitting surface graphic to form a fitting plate; A locking platform and a fixing hole adapted to the Kirschner wire are provided on the working surface of the bonding plate, which can bond and fix the bonding plate to the outer surface of the vertebral plate of the spine through a Kirschner wire, and a positioning guide component and a guide channel thereof are provided on the bonding plate, and a reinforcing block connecting the locking platform and the positioning guide component is further established on the working surface to form a three-dimensional digital model of the positioning navigation body of the spinal pedicle screw implantation surgery navigation template; The three-dimensional digital model is input into a 3D printer for printing to obtain a 3D print of a positioning navigation body of a personalized spinal pedicle screw implantation surgery navigation template for the patient's pedicle screw implantation location point; the 3D print is processed according to medical requirements and equipped with the Kirschner wire to obtain the spinal pedicle screw implantation surgery navigation template.

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