Method for spine positioning and navigation by using 3D printing guide plate and positioning patch

Abstract

The invention relates to the field of spine minimally invasive surgery, and particularly provides a method for spine positioning and navigation through a 3D printing guide plate and a positioning patch. The method comprises the steps that a three-dimensional model is reconstructed through a prone position lumbar vertebra CT / MRI image of a patient, the optimal puncture path and cannula parameters of an endoscope working channel are designed in a computer-aided mode, skin positioning coordinates are generated in combination with body surface projection and lumbar vertebra bony marks, and the 3D printing guide plate is generated based on anatomical features and path planning. The positioning hole channel is accurately matched with a target area; during operation, the positioning paste is attached, the guide plate is fixed, and the guide hole channel punctures to directly reach the intervertebral foramen or the vertebral plate gap; according to the method, positioning coordinates and a three-dimensional structure dynamic optimization path are fused, complex anatomical variation is adapted, and perspective and nerve injury risks in an operation are reduced, so that accurate positioning navigation is realized, the number of puncture times is reduced, soft tissue puncture injury is reduced, radiation exposure in the operation is reduced, the operation time is shortened, and the spinal nerve injury risk is reduced.

Description

Technical Field

[0001] The present invention relates to the field of minimally invasive spinal technology, and in particular to a spinal positioning and navigation method using a 3D printed guide plate and a positioning sticker. Background Art

[0002] Currently, in the field of orthopedics, with the advancement of digital orthopedics and minimally invasive surgery, degenerative diseases such as cervical spondylosis, lumbar disc herniation, and lumbar spinal stenosis can be treated through spinal endoscopy. Due to its advantages of minimal tissue trauma, rapid recovery, and shortened return to work, clinical demand for spinal endoscopy is increasing.

[0003] Lumbar endoscopic surgery is a minimally invasive spinal surgical treatment primarily used to address conditions such as lumbar disc herniation, spinal stenosis, and nerve compression. This technique involves making a tiny incision of approximately 5-8 mm in the patient's lumbar spine. An endoscope equipped with a high-definition camera and light source, along with micro-instruments, is then introduced into the affected area. Using real-time imaging guidance, the surgeon precisely removes the disc nucleus pulposus, osteophytes, or expands the narrow spinal canal space that is compressing the nerves, thereby alleviating pain and neurological dysfunction.

[0004] However, in lumbar endoscopic surgery, puncture positioning and channel establishment are the core difficulties. Although real-time endoscopic imaging can be used to assist the operation, the selection of skin puncture points and the anatomical positioning of the intervertebral foramen or interlaminar space still need to rely on fluoroscopic guidance (such as anteroposterior and lateral X-rays or C-arm machines) and the surgeon's spatial judgment experience. Although some technologies can be assisted by preoperative planning tools (such as three-dimensional navigation or positioning stickers), due to individual differences in patients (such as obesity, scoliosis, intervertebral foraminal stenosis or osteophyte hyperplasia), these tools may reduce accuracy due to anatomical variations and even cause the puncture path to deviate from the expected path. Summary of the Invention

[0005] The present invention provides a spinal positioning and navigation method using a 3D printed guide plate and a positioning sticker, which is used to solve the problems of inaccurate positioning in traditional spinal puncture surgery and the inability to provide specific guide plates for different patients, thereby realizing personalized spinal puncture positioning and navigation.

[0006] The technical solution of the present invention is a method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker, comprising: a 3D printed guide plate and a positioning sticker, and the method comprises:

[0007] Obtain lumbar spine CT / MRI images in the prone position of the patient in advance and reconstruct a 3D model of the lumbar spine;

[0008] Based on the three-dimensional model, the optimal puncture path of the endoscope working channel is calculated, and the diameter of the endoscope working cannula and the operating range of the endoscope are determined;

[0009] Based on the projection of the body surface on the skin to mark the puncture point, combined with bony landmarks such as the lumbar spinous process and iliac crest, the patient-adapted positioning coordinates are generated, that is, the corresponding positioning coordinates are determined on the positioning sticker;

[0010] According to the planned path and the patient's anatomical characteristics, the positioning coordinates and the three-dimensional structure of the spine are used to determine the positioning marks on the 3D printed guide plate, and a target 3D printed guide plate is generated, whose positioning channels fully match the target puncture path;

[0011] After the patient is fixed in the prone position, the positioning mark on the 3D printed guide is determined according to the positioning coordinates and the three-dimensional structure of the spine, and the target 3D printed guide is generated; the positioning sticker is attached and the 3D printed guide is installed, and puncture is performed through the guide hole to directly guide the puncture needle to the target area accurately.

[0012] Preferably, determining the corresponding positioning coordinates on the positioning sticker includes:

[0013] Match the coordinates of the spinal scan image and the positioning sticker;

[0014] For each coordinate point on the positioning sticker, determine the image depth and image range at the coordinate point;

[0015] Determine the lesion target point corresponding to each coordinate point based on the image depth, image range, and correlation of lesion characteristics at each coordinate point;

[0016] According to the lesion target corresponding to each coordinate point, the corresponding positioning coordinates are determined on the positioning sticker and correspond to the 3D printed guide.

[0017] Preferably, obtaining a lumbar CT / MRI image of the patient in a prone position in advance and reconstructing a lumbar 3D model further includes:

[0018] The patient's lumbar spine 3D model and lesion data were input into a pre-set lumbar endoscopic surgery database to match cases with similar anatomical features.

[0019] Obtain surgical planning data and spinal lesion data based on similar case studies. That is, extract historical surgical planning data based on the matching results, including guide parameters, puncture path planning, endoscopic operating range, and nerve avoidance parameters.

[0020] Vectorized modeling of historical surgical data:

[0021] The first vector includes the channel angle, depth, and diameter;

[0022] The second vector includes intervertebral foraminal morphology, nerve root spacing, and dural sac volume;

[0023] The three-dimensional data of the lumbar spine of the current patient is converted into a third vector, and its vector deviation from the historical case is calculated;

[0024] Based on deviation analysis, the puncture path parameters in the first vector are dynamically modified, including needle angle compensation and channel diameter adaptation, to generate a target path that adapts to the current anatomical variation.

[0025] The geometric parameters of the 3D printed guide plate are designed according to the target path, including the guide plate surface, guide channel and fixed support point.

[0026] Preferably, obtaining surgical planning data and spinal lesion data based on similar case studies also includes:

[0027] Obtain surgical operation data of similar cases during the operation;

[0028] Perform feature detection on surgical operation data to obtain a similar feature set;

[0029] In response to determining that a target feature appears in a similar feature set, a corresponding similar treatment case is obtained; wherein,

[0030] The target features are the same lesion characteristics and surgical procedure characteristics as those in the patient's spinal disease data;

[0031] Identify the puncture process of similar treatment cases and determine the target puncture plan;

[0032] A synchronous search is performed based on the target puncture plan and the patient's spinal structure to obtain multimodal search results; among them,

[0033] The multimodal search results include a variety of spinal lesion data similar to the patient and the corresponding spinal three-dimensional structure data.

[0034] Preferably, before determining the positioning mark on the 3D printing guide plate, the method further includes:

[0035] Determine a fitting curve of a 3D printed guide plate that fits the patient's spinal puncture area based on the spinal lesion data and the patient's three-dimensional spinal structure, and determine a first surface point set;

[0036] determining a puncture angle for spinal puncture according to the fitted curve, and setting a second surface point set of the puncture hole according to the puncture angle;

[0037] A solid geometric model of the 3D printing guide plate is determined according to the first surface point set and the second surface point set.

[0038] Preferably, generating a target 3D printing guide plate includes:

[0039] Configure the virtual guide in the reference spinal guide;

[0040] Design the 3D printing process based on the configured virtual guide and solid geometric model;

[0041] Based on the 3D virtual printing process, the contour shape, puncture hole, and guide path of the 3D printed guide are determined, and 3D printing is performed to generate the target 3D printed guide.

[0042] Preferably, before generating the target 3D printing guide plate, the method further includes:

[0043] Obtaining a fitting curve of the patient's spinal puncture area and setting a first navigation constraint; wherein the first navigation constraint is used to constrain the puncture angle and puncture side;

[0044] Acquire the patient's spinal three-dimensional structure and set a second navigation constraint based on the spinal three-dimensional structure; wherein the second navigation constraint is used to constrain the puncture depth and spinal target point error;

[0045] According to the first navigation constraint and the second navigation constraint, navigation optimization of the target 3D printing guide plate is performed.

[0046] Preferably, navigation optimization includes:

[0047] Pre-set multiple optimization items and set corresponding optimization indicators according to the optimization items;

[0048] Performing normalized calculation on the optimization index and the first navigation constraint and the second navigation constraint respectively, and determining a normalized calculation result;

[0049] According to the normalized calculation results, spinal puncture simulation evolution is performed to determine the evolution results;

[0050] According to the evolution results, the navigation optimization process of the target 3D printed guide is determined.

[0051] Preferably, the spinal puncture navigation method further comprises:

[0052] Build a real-time three-dimensional demonstration platform for spinal puncture and determine the puncture hole of the guide plate for real-time spinal puncture;

[0053] The real-time 3D demonstration platform is used to perform navigation alignment based on the patient's prone navigation plane, the positioning coordinates on the positioning sticker, and the puncture holes on the 3D printed guide plate.

[0054] Determine the real-time puncture holes on the target 3GD printing guide plate based on the navigation benchmark;

[0055] During spinal puncture, the needle is tracked based on the real-time puncture hole, and under the guidance of the camera image, the needle is guided to the navigation channel of the locator and simultaneously aligned with the spinal puncture target;

[0056] The spinal puncture target, 3D printed guide, and positioning sticker are verified in a three-in-one manner. After successful verification, the spinal puncture is performed.

[0057] Preferably, the spinal puncture navigation further comprises:

[0058] Pre-set target targeting area;

[0059] Among them, the target area is the patient's spinal puncture target;

[0060] According to the patient's spinal puncture target and the patient's three-dimensional spinal structure, the puncture end is tracked during the puncture process;

[0061] Based on the puncture end tracking, it is determined whether the navigation path of the spinal puncture has deviated.

[0062] The beneficial effects of the present invention are:

[0063] The present invention utilizes a positioning sticker in combination with CT / MRI images of the patient in the prone position to obtain three-dimensional reconstruction data of the lumbar spine (including intervertebral foramen, nerve root course and intervertebral disc lesions), plans the puncture path (puncture point, angle, depth) of the endoscopic working channel through computer multi-dimensional positioning, and designs a semi-arc guide plate based on 3D printing technology, whose curved surface fits the patient's lumbar spinous process and iliac crest bony landmarks. Accurate puncture is achieved through personalized guide plate navigation, which can reduce the time and fluoroscopic radiation of lumbar endoscopic surgery, shorten the operator's learning curve, and the unilateral intervertebral foraminal approach reduces repeated damage to paravertebral muscles and nerve roots compared to multi-angle puncture. The endoscopic working channel directly reaches the outer opening of the intervertebral foramen or the target area of the interlaminar space, maximizing the operating space under the microscope, which is conducive to the complete removal of the protruding nucleus pulposus or hyperplastic ligament. At the same time, the guide plate guide channel is aligned with the outer edge of the pedicle and the projection of the transverse process to ensure that the channel axis is parallel to the nerve root course, avoiding traction injury during the operation. The present invention uses computer fusion of lumbar anatomical vector parameters (such as intervertebral foramen height, dural sac volume, and articular process distance) and combines historical case data to dynamically correct the puncture path, generating a 3D-printed guide that adapts to complex anatomical variations (such as lumbar sacralization and transverse process hypertrophy). Its multiple positioning landmarks (spinous process midline, iliac crest connection line) strictly match the intraoperative body position, thereby improving the accuracy of percutaneous guide navigation. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 This is an image of a positioning sticker marking for spinal positioning in an embodiment of the present invention;

[0065] Figure 2 This is an image of the positioning patch when it is applied to the patient's body surface in an embodiment of the present invention;

[0066] Figure 3 A schematic diagram of a lateral spinal puncture according to an embodiment of the present invention;

[0067] Figure 4 A schematic diagram of puncture point selection for spinal puncture in an embodiment of the present invention;

[0068] Figure 5A flowchart of a method for spinal positioning navigation using a 3D printed guide plate and positioning stickers according to an embodiment of the present invention

[0069] Figure 6 Schematic diagram of the principle of a method for spinal positioning and navigation using a 3D printed guide plate and positioning stickers in an embodiment of the present invention. DETAILED DESCRIPTION

[0070] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0071] Clinically, the specific steps of lumbar endoscopic surgery include: first, the patient is placed prone on the fluoroscopic table, the target segment (such as L4-L5) is located by anteroposterior and lateral X-rays, and the puncture point is marked by a positioning sticker attached to the body surface (such as Figure 1 、 Figure 2 (as shown); local anesthesia is then administered, and a puncture needle is inserted through a small skin incision (approximately 5-8 mm) into the target area (such as the intervertebral foramen or interlaminar space); taking the intervertebral foraminal approach as an example, the puncture needle needs to be inserted from the outer superior edge of the pedicle under fluoroscopic guidance, and the angle is initially determined in combination with the surface markers of the positioning sticker. Then, the path is adjusted through dynamic fluoroscopy during the operation to avoid the nerve roots and dural sac; after confirming that the puncture needle has reached the safe area, a guide wire and expansion cannula are gradually inserted along the puncture needle to finally establish an endoscopic working channel. The endoscopic system is then inserted, and high-definition images are used to identify and remove the diseased tissue (such as a protruding nucleus pulposus or hyperplastic ligament). For patients with obesity or spinal deformity, due to thickening of subcutaneous fat or deviation of anatomical landmarks, the positioning sticker may not be able to accurately correspond to the deep structure. In this case, intraoperative navigation or three-dimensional guide plate assistance is required; after the operation is completed, the endoscope and channel are removed, the incision is sutured, and neurological function is evaluated immediately after the operation.

[0072] The present invention proposes a spinal positioning navigation method using a 3D printed guide plate and a positioning sticker, comprising: a 3D printed guide plate (such as Figure 3 As shown) and positioning stickers (as shown Figure 4 As shown), Figure 5 As shown, the method includes:

[0073] Obtain lumbar spine CT / MRI images in the prone position in advance and reconstruct a three-dimensional model of the lumbar spine (including but not limited to the intervertebral foramen, spinal canal, nerve roots, and lesion areas such as herniated intervertebral disc);

[0074] Based on the three-dimensional model, the optimal puncture path of the endoscopic working channel (including but not limited to puncture point, needle insertion angle, depth, and safe area to avoid nerve roots) is calculated, and the diameter of the endoscopic working cannula and the endoscopic operating range are determined.

[0075] Based on the projection of the body surface on the skin to mark the puncture point, combined with bony landmarks such as the lumbar spinous process and iliac crest, the patient-adapted positioning coordinates are generated, that is, the corresponding positioning coordinates are determined on the positioning sticker;

[0076] Based on the planned path and the patient's anatomical characteristics (including but not limited to pedicle morphology and foraminal stenosis), the positioning coordinates and the three-dimensional structure of the spine are used to determine the positioning landmarks on the 3D printed guide plate, and a target 3D printed guide plate is generated, whose positioning channels fully match the target puncture path;

[0077] After the patient is fixed in the prone position, the positioning sticker is applied and the 3D printed guide plate is installed. Puncture is performed through the guide plate channel to directly guide the puncture needle to the target area (including but not limited to the external opening of the intervertebral foramen or the interlaminar space).

[0078] The principle of the above technical solution is:

[0079] like Figure 6 As shown, the present invention obtains a spinal scan image of the patient in advance. When obtaining the spinal scan image, the patient is required to be in a prone position. In this prone position, the patient's spine can be scanned at all angles through the horizontal plane. During puncture navigation, the horizontal plane of the patient in the prone position is used as the reference horizontal plane for the navigation path. The spinal scan image can be used to scan the entire structure of the patient's spine to determine the lesion area requiring spinal puncture and the three-dimensional structure of the patient's spine.

[0080] Based on the three-dimensional structure of the lumbar spine and lesion data (such as the location of the intervertebral disc herniation and the area of nerve root compression), the puncture path parameters of the endoscopic working channel (including puncture point, needle insertion angle, depth and channel diameter) can be accurately planned, and the target operation area (such as herniated nucleus pulposus or hyperplastic ligament) can be determined. At the same time, combined with the intervertebral foramen morphology, spinal canal volume and nerve root course, the safe puncture range (avoiding nerve roots and dural sac) is calculated, and finally the optimal puncture coordinates in three-dimensional space are generated (such as the external opening of the intervertebral foramen or the interlaminar space entry point), providing precise navigation for establishing the endoscopic channel during surgery.

[0081] Through the lesion location, the puncture path parameters of the endoscope working channel and the optimal puncture coordinates in three-dimensional space, the puncture position on the patient's spine can be determined, and then the actual surgical path can be determined based on the patient's specific spinal disease. Because the patient's puncture position is fitted with a positioning sticker, the positioning coordinates on the positioning sticker can be determined based on the surgical path and the puncture position on the patient's spine.

[0082] The navigation medical device for performing spinal puncture on patients in the present invention is a 3D printed guide, also called a percutaneous guide. The percutaneous guide is used to control the puncture angle and puncture hole. The present invention is a guide manufactured based on 3D printing technology. When manufacturing the 3D printed guide, the puncture hole on the 3D printed guide and the fitting curve of the 3D printed guide in the geometric structure will be determined, so the 3D printed guide will be determined in the form of positioning marks. The positioning marks are the fitting point positioning marks on the puncture hole and the fitting curve and the patient's prone position. Finally, in the actual treatment process, with the patient in the prone position, the horizontal plane under the prone position, the 3D printed guide and the positioning sticker are matched to determine the specific navigation path for the puncture.

[0083] In practice, if Patient A requires spinal surgery, the doctor first obtains a spinal scan with the patient in the prone position and identifies the spinal structure and lesion data. The doctor then determines the corresponding positioning coordinates on the positioning sticker based on the lesion's location. Based on the positioning coordinates and spinal structure, the doctor determines the needle holes and navigation lines on the 3D-printed guide, generating a target 3D-printed guide. Finally, the doctor performs spinal puncture navigation using the target 3D-printed guide and positioning sticker, successfully completing the surgery.

[0084] The beneficial effects of the above technical solution are:

[0085] This method utilizes positioning patches combined with prone CT scans to obtain three-dimensional spinal reconstruction data, computer-aided multi-dimensional positioning and surgical path planning, and 3D printing technology to design a skin-fitting percutaneous guide. Through personalized, precise positioning and navigation, it reduces operative time for percutaneous spinal surgeries (vertebroplasty, percutaneous screws, and percutaneous endoscopy), shortens the learning curve, reduces the number of punctures and puncture injuries, reduces fluoroscopic radiation, and accelerates postoperative recovery. In lumbar endoscopic surgery, the present invention achieves precise puncture through a unilateral intervertebral foraminal or interlaminar approach, which can reduce repeated damage to paravertebral muscles and nerve roots compared to traditional multi-angle attempts; the endoscopic working channel directly reaches the target area (such as a herniated nucleus pulposus or a narrow spinal canal), and the puncture path is guided by a 3D-printed guide plate, so that the channel axis is consistent with the anatomical direction of the intervertebral foramen, ensuring that the endoscopic operating space is maximized and obstruction of neural structures is avoided. Based on preoperative prone CT / MRI fusion data, the computer combines the three-dimensional coordinates of the outer edge of the pedicle, the tip of the transverse process, and the articular process to design the puncture point and needle insertion angle, and generate a semicircular guide plate that fits the curvature of the skin. Its multiple positioning landmarks (such as the spinous process projection and the iliac crest connection line) are strictly matched with the intraoperative body position, so that the guide plate and the patient's lumbar vertebrae bony structure are seamlessly fitted. In addition, the working channel is established by a single planned path, reducing the risk of puncture failure caused by anatomical variations (such as lumbar sacralization and transverse process hypertrophy), significantly shortening the surgeon's learning curve and improving the efficiency of endoscopic decompression. This invention uses a computer to design the surgical site and path using multi-dimensional positioning landmarks, and employs 3D printing technology to create a semicircular guide that conforms more closely to the skin. The use of multiple positioning landmarks for planning ensures consistent positioning between the prone CT scan and the surgical position, and the skin-conforming guide improves the accuracy of percutaneous guide navigation.

[0086] In one embodiment,

[0087] Determining the corresponding positioning coordinates on the positioning sticker includes:

[0088] Match the coordinates of the spinal scan image and the positioning sticker;

[0089] For each coordinate point on the positioning sticker, determine the image depth and image range at the coordinate point;

[0090] Determine the lesion target point corresponding to each coordinate point based on the image depth, image range, and correlation of lesion characteristics at each coordinate point;

[0091] According to the lesion target corresponding to each coordinate point, the corresponding positioning coordinates are determined on the positioning sticker and correspond to the 3D printed guide.

[0092] The principle of the above technical solution is:

[0093] The present invention first obtains a spinal scan image of the patient in the prone position based on the patient's clinical data. Spinal scan images include anteroposterior and lateral spinal radiographs, CT scans, MRIs, etc., and the spinal scan image contains the detailed structure of the patient's spinal structure. The spinal scan image is then aligned with the positioning sticker. A series of virtual coordinate points are set on the positioning sticker, and these coordinate points are aligned one-to-one with the corresponding image coordinates to determine the lesion location and the lesion target point for puncture.

[0094] Then, for each coordinate point, its depth and range in the image need to be determined. In this process, computer-aided diagnostic software is used to automatically extract the depth and range of the corresponding coordinate point based on the characteristics of the image. The current status of the lesion corresponding to each coordinate point needs to be determined based on the correlation between the image depth, image range and lesion characteristics of each coordinate point. After the current status of the lesion at each coordinate point, the present invention determines the corresponding positioning coordinates on the positioning sticker. This positioning coordinate can identify the specific location of the lesion, so that it can correspond to the 3D printing guide.

[0095] As an embodiment of the present invention,

[0096] In the method, a lumbar spine CT / MRI image is obtained in advance with the patient in the prone position, and a 3D model of the lumbar spine (including but not limited to the intervertebral foramen, spinal canal, nerve roots, and lesion areas such as a herniated intervertebral disc) is reconstructed, further comprising:

[0097] The patient's lumbar spine 3D model and lesion data were input into a pre-set lumbar endoscopic surgery database to match cases with similar anatomical features (such as the degree of intervertebral foraminal stenosis and the location of nucleus pulposus protrusion).

[0098] Obtain surgical planning data and spinal lesion data based on similar case studies. That is, extract historical surgical planning data (including guide plate parameters, puncture path planning, endoscopic operation range, and nerve avoidance parameters) based on the matching results.

[0099] Vectorized modeling of historical surgical data (first vector: channel angle / depth / diameter; second vector: intervertebral foramen morphology / nerve root spacing / dural sac volume);

[0100] The three-dimensional data of the lumbar spine of the current patient is converted into a third vector (same dimension as the second vector) and its vector deviation from historical cases (such as pedicle displacement and transverse process morphology) is calculated;

[0101] Based on deviation analysis, the puncture path parameters in the first vector are dynamically modified (such as needle angle compensation and channel diameter adaptation) to generate a target path that adapts to the current anatomical variations (such as lumbar sacralization and transverse process hypertrophy).

[0102] The geometric parameters of the 3D printed guide were designed according to the target path, including the guide surface (fitting the curvature of the lumbar spinous process / iliac crest), the guide channel (matching the projection of the external opening of the intervertebral foramen), and the fixed fulcrum (avoiding the paravertebral soft tissue).

[0103] The principle of the above technical solution is:

[0104] The present invention pre-acquires a patient's spinal scan image to determine the patient's three-dimensional spinal structure and lesion location. This is achieved using medical imaging equipment such as X-ray machines, CT scans, and MRI machines. The present invention inputs the patient's spinal structure and lesion data into a pre-set large spinal model to identify similar case studies. Using these similar case studies, the present invention obtains treatment data and spinal lesion data, namely, the spinal puncture surgical path and corresponding puncture navigation medical instruments used in the treatment of similar pathologies. Surgical planning data primarily includes guide information and the puncture procedure, while spinal lesion data requires further quantification. The present invention performs a first vectorization process on the treatment data from the similar case studies and a second vectorization process on the spinal lesion data. This is done to eliminate variability between cases and make the model more applicable to general situations. The present invention then determines the deviation term between the second and third vectorization results. This allows for identification of potential errors or anomalies in the model processing process and for timely correction. Based on the deviation term, the present invention determines the correlation vectors in the first vectorization process and performs vector compensation to determine the target treatment data, namely, the target surgical planning data. By adjusting the treatment data generation process, the final guide design and puncture process can be more accurately tailored to the individual patient's condition. This method determines the design parameters of the 3D-printed guide based on the target treatment data. This approach uses the model's predictions, combined with the patient's specific condition, to develop the most appropriate guide design and geometric parameters.

[0105] As an embodiment of the present invention,

[0106] The acquisition of treatment data and spinal lesion data through similar case studies also includes:

[0107] Obtain surgical operation data of similar cases during the operation;

[0108] Perform feature detection on surgical operation data to obtain a similar feature set;

[0109] In response to determining that a target feature appears in a similar feature set, a corresponding similar treatment case is obtained; wherein,

[0110] The target features are the same lesion characteristics and surgical procedure characteristics as those in the patient's spinal disease data;

[0111] Identify the puncture process of similar treatment cases and determine the target puncture plan;

[0112] A synchronous search is performed based on the target puncture plan and the patient's spinal structure to obtain multimodal search results; among them,

[0113] The multimodal search results include a variety of spinal lesion data similar to the patient and the corresponding spinal three-dimensional structure data.

[0114] The principle of the above technical solution is:

[0115] The present invention uses data similar to case histories to acquire surgical procedure data and spinal lesion data from the surgical procedure. Through big data analysis, cases with similar conditions are identified, and corresponding treatment data and spinal lesion data are extracted from them for feature detection and matching. Feature detection is performed on the acquired surgical procedure data to obtain a similar feature set. Key features in the data stream, namely surgical procedure features, as well as patient characteristics such as height, weight, and age, are identified. These features are then integrated to form a similar feature set. When a target feature is identified in the similar feature set, the corresponding similar treatment case is acquired. The target feature is typically the same lesion feature as that found in the patient's spinal data. By searching similar cases, patients with the same condition but different specific treatments are identified. Their treatment methods constitute the similar treatment cases we are looking for. Puncture process identification is performed on these similar treatment cases to obtain a target puncture protocol. This involves observing and analyzing the treatment processes of similar treatment cases to identify the most suitable puncture protocol for the current patient. This process may require detailed observation and analysis of each treatment step to identify the most effective approach. Finally, a simultaneous search based on the target puncture plan and the patient's spinal structure is performed to obtain multimodal search results. This is to find spinal lesion data similar to the patient's and the corresponding spinal 3D structure data.

[0116] As an embodiment of the present invention,

[0117] Before determining the positioning mark on the 3D printing guide plate, the method further includes:

[0118] Determine a fitting curve of a 3D printed guide plate that fits the patient's spinal puncture area based on the spinal lesion data and the patient's three-dimensional spinal structure, and determine a first surface point set;

[0119] determining a puncture angle for spinal puncture according to the fitted curve, and setting a second surface point set of the puncture hole according to the puncture angle;

[0120] A solid geometric model of the 3D printing guide plate is determined according to the first surface point set and the second surface point set.

[0121] The principle of the above technical solution is:

[0122] The present invention determines the fitting curve of the 3D printed guide plate based on the spinal lesion data and the patient's spinal three-dimensional structure, by obtaining the spinal lesion data, including information such as the location, size, and shape of the lesion; obtaining the patient's spinal three-dimensional structure information, including information such as the number, height, and curvature of the spinal vertebrae; and determining the geometric shape of the 3D printed guide plate based on the spinal lesion data and the spinal three-dimensional structure information. Specifically, the length and width of the guide plate are determined according to the location and size of the lesion, and the thickness and inclination angle of the guide plate can be determined according to the height and curvature of the spinal vertebrae. Based on the fitting curve, the puncture hole and fitting curve of the spinal puncture are determined, and a surface point set is set. A series of surface points are set on the surface of the guide plate according to certain rules and distances, and these points serve as reference points for puncture. Based on the surface point set, a three-dimensional geometric model of the guide plate is 3D printed. This step includes:

[0123] The determined 3D-printed guide plate geometry is imported into computer-aided design (CAD) software to generate a base model of the guide plate. Based on the surface point set, corresponding surface points are added to the base model to generate a simulation structure. This simulation structure can include surface models of multiple planes, each of which represents the surface shape of a puncture path.

[0124] As an embodiment of the present invention, generating a target 3D printing guide plate includes:

[0125] Configure the virtual guide in the reference spinal guide;

[0126] Design the 3D printing process based on the configured virtual guide and solid geometric model;

[0127] Based on the 3D virtual printing process, the contour shape, puncture hole, and guide path of the 3D printed guide are determined, and 3D printing is performed to generate the target 3D printed guide.

[0128] The principle of the above technical solution is:

[0129] The present invention incorporates a virtual guide into the baseline spinal puncture guide. This transforms the traditional spinal puncture guide into a 3D-printable virtual guide. The generation of the virtual guide requires extensive medical imaging data, such as CT and MRI, to accurately simulate the human skeletal structure and the position of neural tissue. Next, a virtual printing process is designed based on the configured virtual guide and simulated structure. This process is tailored to the shape and position of the virtual guide and the patient's specific condition, resulting in a suitable 3D printing process. The printing process should be designed to ensure surgical safety and effectiveness, while also simplifying the procedure as much as possible. Based on the virtual printing process, the 3D-printed guide's contour shape, puncture hole, and guide path are determined, and 3D printing is performed to generate the target 3D-printed guide. This is the main innovation of the present invention. By directly converting the 3D model of the virtual guide into a physical 3D-printed guide, surgical precision is improved. This also reduces errors caused by human error during the procedure.

[0130] As an embodiment of the present invention, before generating the target 3D printing guide plate, the method further includes:

[0131] Obtaining a fitting curve of the patient's spinal puncture area and setting a first navigation constraint; wherein the first navigation constraint is used to constrain the puncture angle and puncture side;

[0132] Acquire the patient's spinal three-dimensional structure and set a second navigation constraint based on the spinal three-dimensional structure; wherein the second navigation constraint is used to constrain the puncture depth and spinal target point error;

[0133] According to the first navigation constraint and the second navigation constraint, navigation optimization of the target 3D printing guide plate is performed.

[0134] The principle of the above technical solution is:

[0135] In practice, the present invention first requires determining the alignment curve for the patient's spinal puncture area. A first navigation constraint is set to determine the error range for setting the puncture angle and the puncture position on the puncture side. After acquiring the patient's three-dimensional spinal structure, corresponding navigation constraints are set based on this structure. For example, constraints can be set to a certain range between spinal vertebrae to prevent accidental injury during surgery. This constraint can also be determined during the surgical planning phase and retained until the surgical execution. The target 3D printed guide is personalized optimized based on the first and second navigation constraints. After determining the patient's condition and spinal structure and setting the first and second navigation constraints, the target 3D printed guide can be personalized optimized. This process can be performed using computer-aided design (CAD) software, including but not limited to Medical Linearity or IGT Medical. Within this software, the design parameters of the 3D printed guide are adjusted based on the first and second navigation constraints to achieve the optimal surgical outcome. Specifically, the guide's length, angle, and shape are adjusted based on the patient's spinal structure to better fit the patient's anatomy. At the same time, the weight and size of the guide can be optimized based on factors such as the patient's height, weight, and surgical requirements. These optimized parameters can be recorded for direct application in subsequent surgeries.

[0136] As an embodiment of the present invention, the personalized optimization includes:

[0137] Pre-set multiple optimization items and set corresponding optimization indicators according to the optimization items;

[0138] Performing normalized calculation on the optimization index and the first navigation constraint and the second navigation constraint respectively, and determining a normalized calculation result;

[0139] According to the normalized calculation results, spinal puncture simulation evolution is performed to determine the evolution results;

[0140] According to the evolution results, the navigation optimization process of the target 3D printed guide is determined.

[0141] The principle of the above technical solution is:

[0142] This method pre-sets multiple optimization items, sets corresponding optimization indicators based on the optimization items, performs normalized calculations on the first and second navigation constraints, determines the normalized calculation results, then simulates and evolves the spinal puncture based on the normalized calculation results. Finally, based on the evolution results, a personalized optimization process for the target 3D-printed guide is determined. This method can improve the accuracy and efficiency of spinal positioning navigation.

[0143] As an embodiment of the present invention, the spinal puncture navigation method further includes:

[0144] Build a real-time three-dimensional demonstration platform for spinal puncture and determine the puncture hole of the guide plate for real-time spinal puncture;

[0145] The real-time 3D demonstration platform is used to perform navigation alignment based on the patient's prone navigation plane, the positioning coordinates on the positioning sticker, and the puncture holes on the 3D printed guide plate.

[0146] Determine the real-time puncture holes on the target 3GD printing guide plate based on the navigation benchmark;

[0147] During spinal puncture, the needle is tracked based on the real-time puncture hole, and under the guidance of the camera image, the needle is guided to the navigation channel of the locator and simultaneously aligned with the spinal puncture target;

[0148] The spinal puncture target, 3D printed guide, and positioning sticker are verified in a three-in-one manner. After successful verification, the spinal puncture is performed.

[0149] The principle of the above technical solution is:

[0150] First, the present invention establishes a real-time 3D demonstration platform. The primary function of this platform is to perform navigation calibration based on real-time center coordinates. This allows the surgeon to maintain precise navigation calibration throughout the actual procedure, thereby ensuring the accuracy of the surgical procedure. The target center on the target 3D-printed guide is determined based on the real-time center coordinates. This step primarily ensures that the target guide can be accurately located and punctured during subsequent surgical procedures. During a spinal puncture, the puncture needle is tracked based on the target center. In other words, the puncture needle will be precisely aligned with the spinal puncture target along the navigation channel. The final step involves a three-in-one position verification of the spinal puncture target, the 3D-printed guide, and the positioning sticker. Only after successful verification is the actual spinal puncture performed.

[0151] As an embodiment of the present invention,

[0152] The spinal puncture navigation method further includes:

[0153] Pre-set target targeting area;

[0154] Among them, the target area is the patient's spinal puncture target;

[0155] According to the patient's spinal puncture target and the patient's three-dimensional spinal structure, the puncture end is tracked during the puncture process;

[0156] Based on the puncture end tracking, it is determined whether the navigation path of the spinal puncture has deviated.

[0157] The principle of the above technical solution is:

[0158] First, a target region is pre-determined. This region is typically the patient's lesion area. Then, a three-dimensional model of the patient's spine is created based on this target region. This process can utilize any suitable technology and method, such as CT scans or MRI. Through 3D modeling, detailed structural information of the patient's spine is obtained, providing an accurate reference for subsequent procedures. Next, during the puncture procedure, the puncture tip is tracked. This tracking process can be implemented using specialized equipment or software. For example, a camera can be installed on the operating table to capture images of the surgical process. These images are then transmitted in real time to a server, which analyzes them, enabling real-time tracking of the puncture tip. Finally, the puncture tip tracking results can be used to determine if there are any anomalies in the spinal puncture navigation. If so, timely measures can be taken to avoid surgical errors. This approach allows for precise determination of the surgical location, reduces surgical risks, and improves the therapeutic outcome, possessing significant clinical application value. Another advantage of this invention is that it requires no additional hardware or software and can be implemented using existing medical equipment and tools. Furthermore, this method can be flexibly applied to various types of spinal surgery, offering broad application prospects.

[0159] It should be noted that the present invention can also be used for percutaneous spinal precise positioning solutions. In actual operation:

[0160] First, by obtaining a spinal scan image with the patient in the prone position, the patient's spinal three-dimensional structure and spinal lesion data are determined. At this time, surface positioning can be performed first. At this stage, C-arm X-ray or G-arm fluoroscopy is preferentially used to accurately locate the surgical segment, and the puncture point and needle insertion path are marked on the surface to ensure the accuracy of the operation. That is, the three-dimensional spinal structure and spinal lesion data are used to determine the three-dimensional puncture coordinates and the needle insertion path after puncture.

[0161] During the use of the endoscope, a puncture needle is used to follow the puncture hole on the target 3D printed guide plate and the designed path to pass through each layer of tissue (skin-subcutaneous tissue-muscle-intervertebral foramen) in sequence to enter the spinal canal or target area; during the puncture process, the channel is expanded from thin to thick through the guide wire and the step-by-step dilator to establish a working channel; the endoscope is then placed into the target area through the working channel, and the endoscopic angle of view is adjusted to clearly observe the lesion site. If surgery is required, various surgical instruments under the endoscope (such as nucleus pulposus forceps, radiofrequency knife, grinding drill, etc.) are also required to clean and remove the lesion tissue. For cervical disc herniation, lateral mass grinding, posterior longitudinal ligament incision and other operations may be required to expose and remove the protruding nucleus pulposus tissue. For lumbar disc herniation, yellow ligament resection, nerve root release and other operations may be required. During the operation, flushing fluid is used to keep the surgical field clear, and bipolar radiofrequency or electrocoagulation is used for hemostasis. At the same time, the decompression of the dura mater and nerve roots is observed through the endoscope to ensure that the decompression is complete, thereby completing the entire surgical process;

[0162] During surgery, positioning stickers are used to determine the target puncture point, i.e., the endoscopic puncture point. These positioning stickers and 3D-printed guides ensure surgical accuracy. Before surgery, spinal scans can be used to determine the patient's spinal structure and lesion location, as well as case histories, enabling automated surgical planning and quantification of the puncture path.

[0163] The embodiments of the present invention are described in detail above with reference to the accompanying drawings, but the present invention is not limited thereto. Various changes can be made within the scope of knowledge possessed by those skilled in the art without departing from the spirit of the present invention.

Claims

1. A method for spinal positioning navigation using a 3D printed guide plate and positioning stickers, characterized in that: include: 3D printing guides and positioning stickers, methods include: Obtain lumbar spine CT / MRI images in the prone position of the patient in advance and reconstruct a 3D model of the lumbar spine; Based on the three-dimensional model, the optimal puncture path of the endoscope working channel is calculated, and the diameter of the endoscope working cannula and the operating range of the endoscope are determined; Based on the projection of the body surface on the skin to mark the puncture point, combined with bony landmarks such as the lumbar spinous process and iliac crest, the patient-adapted positioning coordinates are generated, that is, the corresponding positioning coordinates are determined on the positioning sticker; According to the planned path and the patient's anatomical characteristics, the positioning coordinates and the three-dimensional structure of the spine are used to determine the positioning marks on the 3D printed guide plate, and a target 3D printed guide plate is generated, whose positioning channels fully match the target puncture path; After the patient is fixed in the prone position, the positioning mark on the 3D printed guide is determined according to the positioning coordinates and the three-dimensional structure of the spine, and the target 3D printed guide is generated; the positioning sticker is attached and the 3D printed guide is installed, and puncture is performed through the guide hole to directly guide the puncture needle to the target area accurately.

2. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 1, characterized in that: Determine the corresponding positioning coordinates on the positioning sticker, including: Match the coordinates of the spinal scan image and the positioning sticker; For each coordinate point on the positioning sticker, determine the image depth and image range at the coordinate point; Determine the lesion target point corresponding to each coordinate point based on the image depth, image range, and correlation of lesion characteristics at each coordinate point; According to the lesion target corresponding to each coordinate point, the corresponding positioning coordinates are determined on the positioning sticker and correspond to the 3D printed guide.

3. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 1, characterized in that: Acquire lumbar spine CT / MRI images in the prone position in advance and reconstruct a 3D model of the lumbar spine, including: The patient's lumbar spine 3D model and lesion data were input into a pre-set lumbar endoscopic surgery database to match cases with similar anatomical features. Obtain surgical planning data and spinal lesion data based on similar case studies. That is, extract historical surgical planning data based on the matching results, including guide parameters, puncture path planning, endoscopic operating range, and nerve avoidance parameters. Vectorized modeling of historical surgical data: The first vector includes the channel angle, depth, and diameter; The second vector includes intervertebral foraminal morphology, nerve root spacing, and dural sac volume; The three-dimensional data of the lumbar spine of the current patient is converted into a third vector, and its vector deviation from the historical case is calculated; Based on deviation analysis, the puncture path parameters in the first vector are dynamically modified, including needle angle compensation and channel diameter adaptation, to generate a target path that adapts to the current anatomical variation. The geometric parameters of the 3D printed guide plate are designed according to the target path, including the guide plate surface, guide channel and fixed support point.

4. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 3, characterized in that: Obtain surgical planning data and spinal lesion data based on similar case studies, including: Obtain surgical operation data of similar cases during the operation; Perform feature detection on surgical operation data to obtain a similar feature set; In response to determining that a target feature appears in the similar feature set, obtaining a corresponding similar treatment case; Among them, the target features are the same lesion features and surgical operation features as those in the patient's spinal disease data; Identify the puncture process of similar treatment cases and determine the target puncture plan; A synchronous search is performed based on the target puncture plan and the patient's spinal structure to obtain multimodal search results; among them, The multimodal search results include a variety of spinal lesion data similar to the patient and the corresponding spinal three-dimensional structure data.

5. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 1, characterized in that: Before determining the positioning marks on the 3D printing guide, it also includes: Determine a fitting curve of a 3D printed guide plate that fits the patient's spinal puncture area based on the spinal lesion data and the patient's three-dimensional spinal structure, and determine a first surface point set; determining a puncture angle for spinal puncture according to the fitted curve, and setting a second surface point set of the puncture hole according to the puncture angle; A solid geometric model of the 3D printing guide plate is determined according to the first surface point set and the second surface point set.

6. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 5, characterized in that: Generating the target 3D printed guide plate includes: Configure the virtual guide in the reference spinal guide; Design the 3D printing process based on the configured virtual guide and solid geometric model; Based on the 3D virtual printing process, the contour shape, puncture hole, and guide path of the 3D printed guide are determined, and 3D printing is performed to generate the target 3D printed guide.

7. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 5, characterized in that: Before generating the target 3D printing guide, it also includes: Obtaining a fitting curve of the patient's spinal puncture area and setting a first navigation constraint; wherein the first navigation constraint is used to constrain the puncture angle and puncture side; Acquire the patient's spinal three-dimensional structure and set a second navigation constraint based on the spinal three-dimensional structure; wherein the second navigation constraint is used to constrain the puncture depth and spinal target point error; According to the first navigation constraint and the second navigation constraint, navigation optimization of the target 3D printing guide plate is performed.

8. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 7, characterized in that: Navigation optimization includes: Pre-set multiple optimization items and set corresponding optimization indicators according to the optimization items; Performing normalized calculation on the optimization index and the first navigation constraint and the second navigation constraint respectively, and determining a normalized calculation result; According to the normalized calculation results, spinal puncture simulation evolution is performed to determine the evolution results; According to the evolution results, the navigation optimization process of the target 3D printed guide is determined.

9. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 1, characterized in that: Other methods of spinal tap navigation include: Build a real-time three-dimensional demonstration platform for spinal puncture and determine the puncture hole of the guide plate for real-time spinal puncture; The real-time 3D demonstration platform is used to perform navigation alignment based on the patient's prone navigation plane, the positioning coordinates on the positioning sticker, and the puncture holes on the 3D printed guide plate. Determine the real-time puncture holes on the target 3GD printing guide plate based on the navigation benchmark; During spinal puncture, the needle is tracked based on the real-time puncture hole, and under the guidance of the camera image, the needle is guided to the navigation channel of the locator and simultaneously aligned with the spinal puncture target; The spinal puncture target, 3D printed guide, and positioning sticker are verified in a three-in-one manner. After successful verification, the spinal puncture is performed.

10. The method for spinal positioning navigation using a 3D printed guide plate and a positioning sticker according to claim 1, characterized in that: The spinal tap navigation further includes: Pre-set target targeting area; Among them, the target area is the patient's spinal puncture target; According to the patient's spinal puncture target and the patient's three-dimensional spinal structure, the puncture end is tracked during the puncture process; Based on the puncture end tracking, it is determined whether the navigation path of the spinal puncture has deviated.

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