Method for selecting a fusion device, fusion device, apparatus, storage medium and electronic device
By acquiring cervical spine medical images and calculating the difference in foramen area, combined with mapping tables and sensor monitoring, the parameters of the fusion device are dynamically selected, solving the problem of low accuracy in fusion device selection in existing technologies, and achieving individualized foramen opening and improved surgical safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-11
- Publication Date
- 2026-03-24
AI Technical Summary
In existing technologies, the design of the laminectomy cage size used in posterior cervical unilateral open laminoplasty lacks individualization, resulting in insufficient or excessive expansion, which affects the abnormal force on the lamina and nerve root traction, and the selection accuracy is low.
By acquiring medical images of the cervical spine, calculating the difference in foramen area before and after the lesion, determining the fusion device parameters in conjunction with a mapping table, using sensors to monitor lamina displacement, and dynamically selecting the target fusion device to match the actual distension requirements.
This technology enables dynamic selection of fusion devices based on individual patient needs, improving the accuracy of foramen opening and surgical safety, reducing the risk of lamina collapse, and enhancing the success rate of bone fusion.
Smart Images

Figure CN121287375B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical devices, and more specifically, to a method for selecting a fusion device, a fusion device, an apparatus, a storage medium, and an electronic device. Background Technology
[0002] Posterior cervical unilateral laminoplasty is a common surgical procedure for treating cervical spinal stenosis. It involves cutting one side of the lamina and leaving the other side as a portal frame, then flipping the lamina outward to widen the spinal canal and achieve decompression. However, this procedure still has significant technical limitations in clinical application.
[0003] Currently used laminectomy cages or titanium plates primarily function for fixation and expansion, and their dimensions are mostly designed based on "empirical values," failing to provide individualized matching according to the degree of cervical spinal stenosis in different patients. Due to the lack of preoperative quantitative design, some patients experience insufficient or excessive expansion, which in severe cases may lead to abnormal laminectomy stress or nerve root traction symptoms. Therefore, these techniques suffer from low accuracy in selecting fusion cages.
[0004] There is currently no effective solution to the aforementioned problems in the relevant technologies. Summary of the Invention
[0005] The main objective of this application is to provide a method for selecting a fusion device, a fusion device, a storage medium, and an electronic device, in order to solve the problem that related technologies rely on human experience to select the fusion device to be used in posterior cervical unilateral open laminoplasty, which has the problem of low accuracy in selecting the fusion device.
[0006] To achieve the above objectives, according to one aspect of this application, a method for selecting a fusion device is provided. The method includes: acquiring medical images of the cervical spine of a target subject; determining, based on the cervical spine medical images, the area of a first vertebral foramen of the target subject before lesion and the area of a second vertebral foramen of the target subject after lesion; determining a target expansion area of the vertebral foramen based on the areas of the first and second vertebral foramina; determining fusion device parameters based on the target expansion area; and determining a target fusion device from a plurality of fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the target cervical spine between two lamina to expand the vertebral foramen area.
[0007] Optionally, the method for selecting the fusion device may also include: calculating the difference between the area of the first vertebral foramen and the area of the second vertebral foramen to obtain the area difference; calculating the product of the area difference and the target coefficient to obtain the target expansion area, wherein the target coefficient is greater than 1.
[0008] Optionally, the method for selecting the fusion device further includes: obtaining a preset mapping table, wherein the mapping table is used at least to record the mapping relationship between the expansion area and the fusion device length; determining the fusion device length that matches the target expansion area from the mapping table to obtain the target fusion device length; and determining the target fusion device length as the fusion device parameter.
[0009] Optionally, the method for selecting the fusion device also includes: after determining the target fusion device from multiple fusion devices based on fusion device parameters, and in the case that the target fusion device has been implanted in the cervical spine of the target object, detecting the target resistance change of the sensor in the target fusion device; determining the target lamina displacement distance matching the target resistance change based on the mapping relationship between the resistance change and the lamina displacement distance; and determining whether the target fusion device has a risk of collapse based on the numerical relationship between the target lamina displacement distance and the distance threshold.
[0010] Optionally, the method for selecting the fusion device also includes: obtaining a safe expansion value of the foramen area before determining whether the target fusion device has a risk of collapse based on the numerical relationship between the target lamina displacement distance and the distance threshold, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and determining the distance threshold based on the target expansion area and the safe expansion value of the foramen area.
[0011] Optionally, the method for selecting the fusion device further includes: determining the target vertebral foramen area based on the second vertebral foramen area and the target expansion area; determining a first coefficient based on the target vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area; determining a second coefficient based on the current vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area, wherein the current vertebral foramen area refers to the vertebral foramen area after the target fusion device is implanted into the cervical spine; calculating a first product between the first coefficient and the target expansion area, and calculating a second product between the second coefficient and the safe expansion value of the vertebral foramen area; and determining a distance threshold based on the first product and the second product.
[0012] Optionally, the method for selecting the fusion device also includes: after determining whether the target fusion device has a risk of collapse, and if it is determined that the target fusion device does not have a risk of collapse, obtaining the safe expansion value of the foramen area, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and processing the target expansion area, the target lamina displacement distance, the safe expansion value of the foramen area, and the implantation time of the target fusion device through a fusion trend prediction model to obtain a bone fusion risk value, wherein the bone fusion risk value is used to characterize the probability of fusion failure between the lamina and the target fusion device.
[0013] To achieve the above objectives, according to another aspect of this application, a fusion device is provided. This fusion device, determined based on the aforementioned fusion device selection method, includes: a fusion device body having a bone graft cavity extending through the fusion device body; and a sensor embedded below a target end face of the fusion device body, wherein the target end face is an end face for contacting the vertebral laminae of the target object, and the target end face has a thin-walled deformation zone covering the sensor. The thin-walled deformation zone deforms as the bone material in the bone graft cavity fuses with the cervical vertebrae, and the sensor is used to detect this deformation.
[0014] Optionally, an anti-slip structure is provided on the target end face.
[0015] To achieve the above objectives, according to another aspect of this application, a fusion device is provided. The device includes: a first acquisition module for acquiring medical images of the cervical spine of a target subject; a first determination module for determining, based on the cervical spine medical images, the area of a first vertebral foramen before lesion and the area of a second vertebral foramen after lesion in the target subject; a second determination module for determining a target expansion area of the vertebral foramen based on the areas of the first and second vertebral foramina; and a third determination module for determining fusion device parameters based on the target expansion area, and determining a target fusion device from a plurality of fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the cervical spine between two lamina to expand the area of the vertebral foramen.
[0016] Optionally, the second determining module further includes: a first calculation submodule, used to calculate the difference between the area of the first vertebral foramen and the area of the second vertebral foramen to obtain the area difference; and a second calculation submodule, used to calculate the product of the area difference and the target coefficient to obtain the target expansion area, wherein the target coefficient is greater than 1.
[0017] Optionally, the third determining module further includes: a first obtaining submodule, used to obtain a preset mapping table, wherein the mapping table is used to record at least the mapping relationship between the expansion area and the fusion length; a first determining submodule, used to determine the fusion length that matches the target expansion area from the mapping table, thereby obtaining the target fusion length; and a second determining submodule, used to determine the target fusion length as a fusion parameter.
[0018] Optionally, the fusion device selection device further includes: a detection module for detecting the target resistance change of the sensor in the target fusion device when the target fusion device has been implanted in the cervical spine of the target object; a fourth determination module for determining the target lamina displacement distance matching the target resistance change based on the mapping relationship between the resistance change and the lamina displacement distance; and a fifth determination module for determining whether the target fusion device has a risk of collapse based on the numerical relationship between the target lamina displacement distance and the distance threshold.
[0019] Optionally, the selection device for the fusion unit further includes: a second acquisition module for acquiring a safe expansion value of the foramen area, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and a sixth determination module for determining a distance threshold based on the target expansion area and the safe expansion value of the foramen area.
[0020] Optionally, the sixth determining module further includes: a third determining submodule, used to determine the target vertebral foramen area based on the second vertebral foramen area and the target expansion area; a fourth determining submodule, used to determine a first coefficient based on the target vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area; a fifth determining submodule, used to determine a second coefficient based on the current vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area, wherein the current vertebral foramen area refers to the vertebral foramen area after the target fusion device is implanted into the cervical spine; a third calculation submodule, used to calculate a first product between the first coefficient and the target expansion area, and to calculate a second product between the second coefficient and the safe expansion value of the vertebral foramen area; and a sixth determining submodule, used to determine a distance threshold based on the first product and the second product.
[0021] Optionally, the fusion device selection device further includes: a third acquisition module, used to acquire a safe expansion value of the foramen area when it is determined that the target fusion device has no risk of collapse, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and a processing module, used to process the target expansion area, the target lamina displacement distance, the safe expansion value of the foramen area, and the implantation time of the target fusion device through a fusion trend prediction model to obtain a bone fusion risk value, wherein the bone fusion risk value is used to characterize the probability of fusion failure between the lamina and the target fusion device.
[0022] To achieve the above objectives, according to another aspect of this application, a computer-readable storage medium is provided, the computer-readable storage medium including a stored executable program, wherein, when the executable program is running, the device on which the computer-readable storage medium is located controls the execution of the above-described fusion selector method.
[0023] To achieve the above objectives, according to another aspect of this application, an electronic device is provided, the electronic device including a memory storing an executable program; and a processor for running the program, wherein the program executes the above-described fusion selector method during runtime.
[0024] To achieve the above objectives, according to another aspect of this application, a computer program product is provided, including computer instructions that, when executed by a processor, implement the steps of the above-described fusion selector method.
[0025] In this embodiment, the area of the first vertebral foramen in a healthy state and the area of the second vertebral foramen in a diseased state of the target object are determined based on the cervical spine medical image of the target object, and the target expansion area is determined accordingly. This achieves effective determination of the additional area that the fusion device needs to expand. By determining the fusion device parameters based on the target expansion area, and determining the target fusion device from multiple fusion devices based on the fusion device parameters, the target fusion device is dynamically selected based on the actual vertebral foramen expansion requirements of the target object's cervical spine, thereby improving the accuracy of fusion device selection.
[0026] Therefore, the method provided in this application achieves the goal of dynamically selecting the fusion cage based on the actual vertebral foramen opening requirements of the patient's cervical spine, thereby improving the accuracy of fusion cage selection. It also solves the technical problem of low accuracy in selecting the fusion cage required for posterior cervical unilateral open laminoplasty, which relies on manual experience. Attached Figure Description
[0027] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments and descriptions of this application are used to explain this application and do not constitute an undue limitation of this application. In the drawings:
[0028] Figure 1 This is a hardware structure block diagram of a computer terminal provided according to an embodiment of this application;
[0029] Figure 2 This is a flowchart of a fusion selection method provided according to an embodiment of this application;
[0030] Figure 3 This is a schematic diagram of the cross-section of the spinal canal in a cervical spine medical image provided according to an embodiment of this application;
[0031] Figure 4 This is a schematic diagram illustrating the use of the target fusion device according to an embodiment of this application;
[0032] Figure 5 This is a schematic diagram of a fusion device provided according to an embodiment of this application;
[0033] Figure 6 This is a schematic diagram of the selection device for the fusion device provided according to an embodiment of this application;
[0034] Figure 7 This is a structural block diagram of an electronic device according to an embodiment of this application. Detailed Implementation
[0035] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present application, and not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort should fall within the scope of protection of the present application.
[0036] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.
[0037] It should be noted that the information collected in this application (including but not limited to user device information, user personal information, etc.) and data (including but not limited to data used for display, data used for analysis, etc.) are information and data authorized by the user or fully authorized by all parties. Furthermore, the collection, storage, use, processing, transmission, provision, disclosure, and application of this data all comply with relevant laws, regulations, and standards, necessary confidentiality measures have been taken, and they do not violate public order and good morals. Corresponding access points are provided for users to choose to authorize or refuse. For example, interfaces are set up between this system and relevant users or organizations, providing users with corresponding access points to choose to agree to or refuse automated decision-making results; if the user chooses to refuse, the process proceeds to the expert decision-making stage.
[0038] Example 1
[0039] According to an embodiment of this application, an embodiment of a fusion selector method is also provided. It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions. Furthermore, although a logical order is shown in the flowchart, in some cases, the steps shown or described may be executed in a different order than that shown here.
[0040] The method embodiment provided in Embodiment 1 of this application can be executed on a mobile terminal, computer terminal, or similar computing device. Figure 1A hardware block diagram of a computer terminal (or mobile device) for implementing a fusion selector method is shown. Figure 1 As shown, the computer terminal 10 (or mobile device) may include one or more processors 102 (shown as 102a, 102b, ..., 102n in the figure) 102 (processor 102 may include, but is not limited to, a microprocessor (MCU) or a field-programmable gate array (FPGA), etc.), a memory 104 for storing data, and a transmission device 106 for communication functions. In addition, it may also include: a display, an input / output (I / O) interface, a Universal Serial Bus (USB) port (which may be included as one of the ports of a BUS bus), a network interface, a power supply, and / or a camera. Those skilled in the art will understand that... Figure 1 The structure shown is for illustrative purposes only and does not limit the structure of the aforementioned electronic device. For example, computer terminal 10 may also include... Figure 1 The more or fewer components shown, or having the same Figure 1 The different configurations shown.
[0041] It should be noted that the aforementioned one or more processors 102 and / or other data processing circuits are generally referred to herein as "data processing circuits". These data processing circuits may be embodied, in whole or in part, in software, hardware, firmware, or any other combination thereof. Furthermore, the data processing circuits may be a single, independent processing module, or may be integrated, in whole or in part, into any other element within the computer terminal 10 (or mobile device). As involved in the embodiments of this application, the data processing circuits serve as a processor control mechanism (e.g., selection of a variable resistor termination path connected to an interface).
[0042] The memory 104 can be used to store software programs and modules of application software, such as the program instructions / data storage device corresponding to the fusion selection method in this embodiment. The processor 102 executes various functional applications and data processing by running the software programs and modules stored in the memory 104, thereby implementing the aforementioned fusion selection method. The memory 104 may include high-speed random access memory, and may also include non-volatile memory, such as one or more magnetic storage devices, flash memory, or other non-volatile solid-state memory. In some instances, the memory 104 may further include memory remotely located relative to the processor 102, and these remote memories can be connected to the computer terminal 10 via a network. Examples of such networks include, but are not limited to, the Internet, corporate intranets, local area networks, mobile communication networks, and combinations thereof.
[0043] The transmission device 106 is used to receive or send data via a network. Specific examples of the network described above may include a wireless network provided by the communication provider of the computer terminal 10. In one example, the transmission device 106 includes a Network Interface Controller (NIC), which can connect to other network devices via a base station to communicate with the Internet. In another example, the transmission device 106 may be a Radio Frequency (RF) module, used for wireless communication with the Internet.
[0044] The display can be, for example, a touchscreen liquid crystal display (LCD), which allows the user to interact with the user interface of the computer terminal 10 (or mobile device).
[0045] Under the aforementioned operating environment, this application provides the following: Figure 2 The method for selecting the fusion device is shown. Figure 2 This is a flowchart of the fusion selection method according to Embodiment 1 of this application.
[0046] Step S201: Obtain medical images of the cervical spine of the target object.
[0047] Optionally, electronic devices, application systems, servers, and other devices can be used as the execution subject of this application. In this embodiment, the target processing system is used as the execution subject to execute the above-mentioned fusion selection method.
[0048] The target patient can be understood as a patient undergoing posterior unilateral open laminar flow cervical spine surgery, for example, a patient with cervical spinal stenosis. The cervical spine medical images of the target patient include the lesion area of the cervical spine; that is, the cervical spine medical images are medical images of the diseased cervical vertebrae of the target patient. The cervical spine medical images of the target patient can be CT (Computed Tomography), MRI (Magnetic Resonance Imaging), CBCT (Cone Beam CT), PET (Positron Emission Tomography), etc.
[0049] In an optional embodiment, the cervical spine medical images may be medical images of the 3rd to 6th cervical vertebrae.
[0050] Step S202: Determine the area of the first vertebral foramen of the target object's cervical spine before the lesion and the area of the second vertebral foramen of the target object after the lesion based on cervical spine medical images.
[0051] The vertebral foramen is a structure of the vertebrae (including the cervical vertebrae), formed by the vertebral body and the vertebral arch behind it. The vertebral arch includes the pedicles and the lamina, which can also be called the laminae. All the vertebral foramina are interconnected along the vertical direction of the spine, forming the vertebral canal, which contains the spinal cord.
[0052] Cervical spinal stenosis is a common degenerative disease. With age, the intervertebral discs in the cervical spine may degenerate, osteophytes may form at the vertebral margins, the ligamentum flavum may thicken, and joint hyperplasia may occur, leading to a reduction in the spinal canal volume. This can then compress the spinal cord or nerve roots, causing symptoms such as neck pain, numbness and weakness in the arms, walking difficulties, and even bowel and bladder dysfunction. In posterior cervical spine surgery, laminectomy (such as single-door laminectomy) aims to widen the vertebral foramen, reduce spinal cord compression, and thus treat cervical spinal stenosis and related conditions.
[0053] After acquiring medical images of the cervical spine, a cross-sectional image of the spinal canal can be determined from these images. Then, based on this cross-sectional image, the area of the first vertebral foramen before the lesion and the area of the second vertebral foramen after the lesion are determined. The area of the first vertebral foramen can be understood as the actual area of the foramen of the target cervical spine in a healthy state. The area of the second vertebral foramen can be understood as the area of the foramen of the target cervical spine in a lesion state (such as spinal stenosis).
[0054] In an optional embodiment, the cross-sectional image of the spinal canal can be input into a foramen area recognition model. The model identifies the areas of healthy and diseased foramina within the cross-section of the spinal canal, yielding the first and second foramina areas. The foramen area recognition model can be a neural network model, trained using a training sample set. The training samples in the training sample set are cross-sectional images of the spinal canal of the sample object, and the true labels of the training samples are the healthy and diseased foramina areas corresponding to the cross-sectional images of the spinal canal.
[0055] In another optional embodiment, a binary segmentation algorithm can be used to extract the boundary of the vertebral foramen region. For example, when identifying the area of the first vertebral foramen, a preset first value is used as the threshold for binary segmentation. If the gray value of a certain pixel point in the cross-sectional image of the spinal canal is higher than this threshold, it is considered a non-vertebral foramen region; if the gray value of a certain pixel point in the cross-sectional image of the spinal canal is lower than or equal to this threshold, it is considered a vertebral foramen region. When identifying the area of the second vertebral foramen, a preset second value is used as the threshold for binary segmentation. If the gray value of a certain pixel point in the cross-sectional image of the spinal canal is higher than this threshold, it is considered a non-vertebral foramen region; if the gray value of a certain pixel point in the cross-sectional image of the spinal canal is lower than or equal to this threshold, it is considered a vertebral foramen region. And the second value is less than the first value.
[0056] For example, Figure 3 is a schematic diagram of the cross-section of the spinal canal in a cervical spine medical image provided by an embodiment of the present application. Figure 3 The circled area pointed by the arrow in [Figure] is the cervical spine lesion area of the target object, and the inverted triangular area where the cervical spine lesion area is located is the vertebral foramen. When calculating the area of the first vertebral foramen, the lesion area is ignored based on the binary segmentation algorithm with the first value as the threshold; when calculating the area of the second vertebral foramen, the lesion area is concerned based on the binary segmentation algorithm with the second value as the threshold.
[0057] Optionally, the area of the first vertebral foramen before the lesion can be expressed as:
[0058]
[0059] Where, represents the area of the first vertebral foramen; represents whether the i-th pixel point belongs to the vertebral foramen region before the lesion. means belonging when means not belonging when; s is the actual area represented by a single pixel.
[0060] Optionally, the area of the second vertebral foramen after the lesion can be expressed as:
[0061]
[0062] Where, represents the area of the second vertebral foramen; represents whether the i-th pixel point belongs to the vertebral foramen region after the lesion. To treat a range of nerve compression symptoms caused by cervical spinal stenosis, a distraction procedure is needed to open the spinal foramen, physically increasing the diameter and volume of the cervical spinal canal. This provides more space for the compressed spinal cord and nerve roots, relieving or eliminating nerve compression. Therefore, determining the required area of foramen distraction before performing the surgery is crucial. The target distraction area mentioned above refers to the additional area the fusion device needs to open to restore or achieve the ideal foramen size for the target patient's cervical spine.
[0065] In an optional embodiment, the difference between the area of the first vertebral foramen and the area of the second vertebral foramen can be calculated, and the difference can be determined as the target opening area.
[0066] In an optional embodiment, considering the postoperative foraminal space requirements and the possibility of some retraction, the target expansion area can be obtained by multiplying the difference between the areas of the first and second vertebral foramina by a target coefficient after calculation. The target coefficient can be understood as an empirical correction coefficient, which is a value greater than 1.
[0067] Step S204: Determine the fusion device parameters based on the target expansion area, and determine the target fusion device from multiple fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the cervical vertebrae between the two lamina to expand the foramen area.
[0068] Optionally, the merger parameters may include at least the target merger length L.
[0069] In an optional embodiment, the target processing system can input the target expansion area into a fusion selector model, and process the target expansion area through the fusion selector model to obtain the target fusion length. The fusion selector model can be a neural network model, which can be trained based on a training sample set. The training samples in the training sample set can be the sample expansion areas corresponding to the cervical vertebrae of the sample object, and the true labels of the training samples can be the reference fusion lengths corresponding to the sample expansion areas.
[0070] In another optional embodiment, the target processing system may have a pre-set mapping table, which is used to record at least the mapping relationship between the expansion area and the fusion length. After determining the target expansion area, the target processing system can determine the fusion length that matches the target expansion area based on the mapping table, thus obtaining the target fusion length.
[0071] Optionally, in addition to the target fusion cage length L, the fusion cage parameters may also include the fusion cage opening angle θ and the interlaminar spacing D. The opening angle θ and the interlaminar spacing D can be used for intraoperative navigation and positioning, and the aforementioned interlaminar spacing D is used to determine the position of the laminectomy blade. In this case, a mapping table is used to record the mapping relationship between the opening area, opening angle, interlaminar spacing, and fusion cage length. For example, when the target opening area is 92 mm², by looking up the table, L = 14 mm, θ = 17°, and D = 4.8 mm are obtained.
[0072] After determining the fusion cage parameters, the fusion cage that matches these parameters from among multiple fusion cages is identified as the target fusion cage. The cervical spine contains two laminae, left and right. The target fusion cage is placed between the laminae on either side of the cervical spine to provide support and expansion. By expanding the laminae, the cross-sectional area of the spinal canal (i.e., the vertebral foramen) increases, thereby relieving pressure on the spinal cord or nerves. For example, Figure 4 This is a schematic diagram illustrating the use of the target fusion device according to an embodiment of this application. Figure 4 In this procedure, after the target fusion device is implanted into the cervical spine, the area of the vertebral foramen is effectively expanded.
[0073] Optionally, the above steps S201-S204 can be performed before the operation.
[0074] In this embodiment, the area of the first vertebral foramen in a healthy state and the area of the second vertebral foramen in a diseased state of the target object are determined based on the cervical spine medical image of the target object, and the target expansion area is determined accordingly. This achieves effective determination of the additional area that the fusion device needs to expand. By determining the fusion device parameters based on the target expansion area, and determining the target fusion device from multiple fusion devices based on the fusion device parameters, the target fusion device is dynamically selected based on the actual vertebral foramen expansion requirements of the target object's cervical spine, thereby improving the accuracy of fusion device selection.
[0075] Therefore, the method provided in this application achieves the goal of dynamically selecting the fusion cage based on the actual vertebral foramen opening requirements of the patient's cervical spine, thereby improving the accuracy of fusion cage selection. It also solves the technical problem of low accuracy in selecting the fusion cage required for posterior cervical unilateral open laminoplasty, which relies on manual experience.
[0076] Optionally, in the fusion device selection method provided in the embodiments of this application, determining the target expansion area of the vertebral foramen based on the area of the first vertebral foramen and the area of the second vertebral foramen includes: calculating the difference between the area of the first vertebral foramen and the area of the second vertebral foramen to obtain the area difference; calculating the product of the area difference and the target coefficient to obtain the target expansion area, wherein the target coefficient is greater than 1.
[0077] Optionally, the target processing system can subtract the area of the second vertebral foramen from the area of the first vertebral foramen to obtain the area difference.
[0078] Considering that the lamina may naturally retract after the target fusion device is implanted into the cervical spine of the target coefficient object, a target coefficient can be preset. The role of the target coefficient is to add extra expansion requirements on the basis of the area difference, so as to take into account the safety margin during the operation and the ideal state of the vertebral foramen restoration.
[0079] For example, the target expansion area can be calculated based on the following formula:
[0080]
[0081] in, The target area is represented by k, which represents the target coefficient. The target coefficient is greater than 1, for example, it can take the value in the range of 1.3-1.4.
[0082] It should be noted that by multiplying the target coefficient by the area difference to determine the target expansion area, the original size of the vertebral foramen can be restored while providing additional space to compensate for natural retraction after surgery and to avoid restenosis of the vertebral foramen, thereby improving the accuracy of the determined target expansion area.
[0083] Optionally, in the fusion device selection method provided in the embodiments of this application, determining the fusion device parameters based on the target expansion area includes: obtaining a preset mapping table, wherein the mapping table is at least used to record the mapping relationship between the expansion area and the fusion device length; determining the fusion device length that matches the target expansion area from the mapping table to obtain the target fusion device length; and determining the target fusion device length as the fusion device parameter.
[0084] In an optional embodiment, the mapping table may record multiple mapping relationships between the expansion area range and the fusion length. For example, when the expansion area is in the range of 91-92 mm², the corresponding fusion length L = 14 mm; when the expansion area is in the range of 92-93 mm², the corresponding fusion length L = 15 mm.
[0085] In another optional embodiment, to improve the accuracy of fusion selection, the mapping table can record multiple mapping relationships between the expansion area and the fusion length. For example, when the expansion area is 92 mm², the corresponding fusion length L = 14 mm; when the expansion area is 92.5 mm², the corresponding fusion length L = 14.5 mm.
[0086] The target processing system can determine the fusion length that matches the target expansion area based on a mapping table, thus obtaining the target fusion length. After determining the target fusion length, the target fusion length is set as a fusion parameter for selecting the target fusion.
[0087] It should be noted that by using a preset mapping table, the individualized expansion area requirements can be transformed into specific fusion unit length parameters, which can effectively determine the accuracy of fusion unit parameters and thus improve the accuracy of fusion unit selection.
[0088] Optionally, in the fusion device selection method provided in the embodiments of this application, after determining the target fusion device from multiple fusion devices based on fusion device parameters, the method further includes: when the target fusion device has been implanted in the cervical spine of the target object, detecting the target resistance change of the sensor in the target fusion device; determining the target lamina displacement distance matching the target resistance change based on the mapping relationship between the resistance change and the lamina displacement distance; and determining whether the target fusion device has a risk of collapse based on the numerical relationship between the target lamina displacement distance and the distance threshold.
[0089] In an optional embodiment, a sensor is incorporated within the target fusion device to monitor micro-displacement between the two cervical lamina in real time. This sensor may be a strain gauge sensor, whose resistance changes with strain. After being insulated and encapsulated, this sensor is suitable for in vivo implantation and has a measurement range of 0-15 mm. Following fusion device implantation, the sensor continuously monitors the biomechanical environment of the cervical spine; its resistance changes whenever interlaminar displacement occurs.
[0090] Optionally, the sensors in the target fusion unit can be wirelessly coupled to an external data reader to collect resistance change data from the sensors. For example, the external data reader can collect resistance change data (i.e., target resistance change) daily and automatically upload resistance change curve trend data weekly. Target resistance change refers to the resistance change value recorded by the sensor during monitoring, which is a physical quantity reflecting interlaminar displacement or stress changes.
[0091] Optionally, the relationship between the sensor output signal (resistance change ΔR) and the actual lamina displacement (Δx) can be obtained manually through calibration tests before implantation. For example, before fusion cage implantation (i.e., preoperatively), researchers calibrate the sensor using a series of cervical spine models with known displacements, recording the sensor resistance change at specific displacements. Through experimental data analysis, a linear regression model or lookup table is constructed between the resistance change and the lamina displacement. For example, the aforementioned relationship can be described by the following linear formula:
[0092]
[0093] in, Indicates the displacement distance of the target vertebral lamina; b = 0.011 mm; This represents the change in the target resistance.
[0094] For example, when ΔR = 80Ω, according to the above formula, we can obtain: .
[0095] When the target fusion device has been implanted in the cervical spine of the target patient, that is, after the operation, the target processing system can count the above-mentioned Δx according to a preset time period.
[0096] After determining the target lamina displacement distance, the risk of collapse of the target fusion device is determined based on the numerical relationship between the target lamina displacement distance and a distance threshold. The distance threshold is the maximum allowable displacement between the lamina and the target fusion device. The aforementioned collapse risk can be understood as the collapse of the end face of the target fusion device that contacts the lamina, resulting in an abnormal displacement distance of the lamina. Optionally, if the target lamina displacement distance is greater than or equal to the distance threshold, a collapse risk is determined for the target fusion device. In this case, a "lamina collapse risk" alarm can be sent to the physician's device terminal. If the target lamina displacement distance is less than the distance threshold, no collapse risk is determined for the target fusion device.
[0097] For example, if the distance threshold is set to 2mm, and the target vertebral lamina displacement reaches 1.58mm in a certain monitoring, then it is determined that there is no risk of collapse.
[0098] In an optional embodiment, the aforementioned distance threshold is a preset fixed value.
[0099] In another optional embodiment, the aforementioned distance threshold is dynamically determined based on the target expansion area and the safe expansion value of the vertebral foramen area.
[0100] It is important to note that current clinical practice lacks real-time monitoring methods for postoperative laminar stability and bone fusion progress. Once laminar collapse or bone graft material absorption occurs, it is often only detected in imaging after symptoms appear, missing the optimal intervention window. Traditional implantable devices lack any monitoring structures and the ability to provide postoperative data feedback. By embedding sensors within the fusion device, and utilizing the mapping relationship between resistance changes and laminar displacement, the raw sensor data is converted into cervical laminar data. Based on a set distance threshold, it automatically assesses the risk of laminar collapse, achieving effective postoperative monitoring of spinal canal widening surgery. This can significantly improve the safety of spinal canal widening surgery and the success rate of bone fusion.
[0101] Optionally, in the fusion device selection method provided in the embodiments of this application, before determining whether the target fusion device has a risk of collapse based on the numerical relationship between the target vertebral laminar displacement distance and the distance threshold, the method further includes: obtaining the safe expansion value of the foramen area, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and determining the distance threshold based on the target expansion area and the safe expansion value of the foramen area.
[0102] In an optional embodiment, the safe expansion value of the foramen area refers to the minimum foramen opening threshold required to maintain cervical spine stability and neurological function safety postoperatively. This safe expansion value can be predetermined by the physician. For example, assuming the patient's preoperative foramen area (i.e., the second foramen area) is 300 mm². 2 The minimum perforation area (i.e., the safe value of perforation area) that patients need to achieve after surgery to maintain stability and neurological function is 350 mm². 2 Therefore, the minimum opening area threshold of the vertebral foramen is (350-300) mm. 2 =50mm 2 That is, the safe expansion value of the vertebral foramen area is equal to the difference between the area of the second vertebral foramen and the safe value of the vertebral foramen area.
[0103] Optionally, the safe expansion value of the foramen area can be determined based on the minimum safe value of the intervertebral space. The intervertebral space is the remaining space after subtracting the area occupied by the spinal cord and nerve roots from the cross-sectional area of the foramen; that is, the effective space within the foramen that allows the spinal cord and nerves to move freely without compression. The size of the intervertebral space is directly related to the health of the cervical spine and the surgical outcome. In posterior cervical spine surgeries, such as single-door cervical laminoplasty, the intervertebral space is a very important consideration. One of the main objectives of the surgery is to increase the intervertebral space by expanding the lamina, thereby relieving nerve compression symptoms caused by cervical spinal stenosis, such as neck pain, arm numbness, or difficulty walking.
[0104] After obtaining the safe expansion value of the foramen area, a distance threshold is determined based on the target expansion area and the safe expansion value of the foramen area. For example, the target expansion area and the safe expansion value of the foramen area are input into a distance threshold prediction model, and the distance threshold is determined by the distance threshold prediction model. The distance threshold prediction model can be a neural network model, which can be trained using a training sample set. The training samples in this set can be the sample expansion area and the sample safe expansion value of the foramen area of the sample object, and the ground truth label can be the reference distance threshold corresponding to the training sample.
[0105] For example, the target expansion area and the safe expansion area of the vertebral foramen are substituted into the preset distance threshold calculation formula, and the distance threshold is calculated based on the distance threshold calculation formula.
[0106] For example, a preset mapping table can be obtained, which records the interlaminar space values (also known as interlaminar spacing values) corresponding to different expansion areas. The target processing system can determine the lamina displacement distance corresponding to the target expansion area from the mapping table and identify it as the actual interlaminar space after surgery; it can also determine the interlaminar space value corresponding to the safe expansion value of the foramen area from the mapping table and identify it as the minimum safe interlaminar space after surgery. Subtracting the minimum safe interlaminar space from the actual interlaminar space yields the distance threshold.
[0107] It should be noted that by determining the distance threshold based on the target expansion area and the safe expansion value of the vertebral foramen area, the distance threshold can be dynamically determined by combining the actual postoperative effect and postoperative safety requirements, thereby improving the accuracy of the determined distance threshold.
[0108] Optionally, in the fusion device selection method provided in this application embodiment, determining the distance threshold based on the target expansion area and the safe expansion value of the vertebral foramen area includes: determining the target vertebral foramen area based on the second vertebral foramen area and the target expansion area; determining a first coefficient based on the target vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area; determining a second coefficient based on the current vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area, wherein the current vertebral foramen area refers to the vertebral foramen area after the target fusion device is implanted into the cervical spine; calculating a first product between the first coefficient and the target expansion area, and calculating a second product between the second coefficient and the safe expansion value of the vertebral foramen area; and determining the distance threshold based on the first product and the second product.
[0109] Optionally, the area of the second vertebral foramen and the target expansion area can be added together to obtain the target vertebral foramen area, which is also the vertebral foramen area expected to be achieved after surgery (after expansion).
[0110] Optionally, the longitudinal diameter of the vertebral foramen refers to the length of the cervical vertebral foramen in the target direction of the cervical vertebral cross-section. The target direction is the anterior-posterior direction, i.e., longitudinal. For example, in Figure 4 In the middle, the target fusion device expands the two vertebral laminae to the left and right, and the target direction is... Figure 4 The vertebral foramen is a part of the cervical spine's skeletal structure, a space formed by the vertebral body and vertebral arch, through which the spinal cord and nerve roots pass. The shape of the vertebral foramen resembles an irregular elliptical passage; its transverse and longitudinal lengths in the cross-section of the cervical spine, as well as its depth along the cervical spine's axis, together determine the volume of the vertebral foramen and the available space for neural structures.
[0111] The target processing system can obtain a first coefficient by dividing the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area by the target vertebral foramen area, and a second coefficient by dividing the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area by the current vertebral foramen area. The current vertebral foramen area refers to the latest vertebral foramen area after the target fusion device is implanted in the cervical spine; that is, the vertebral foramen area measured in the most recent actual measurement after surgery and implantation of the fusion device in the cervical spine.
[0112] After determining the sum of the first and second coefficients, the distance threshold can be calculated based on the following formula:
[0113]
[0114] in, Indicates the distance threshold. Indicates the first coefficient. Indicates the second coefficient. Indicates the target area to be expanded. This represents the safe expansion value of the vertebral foramen area. In an optional embodiment, for example, , .
[0115] It should be noted that the above method enables the effective calculation of the distance threshold.
[0116] Optionally, in the fusion device selection method provided in the embodiments of this application, after determining whether the target fusion device has a risk of collapse, the method further includes: if it is determined that the target fusion device does not have a risk of collapse, obtaining a safe expansion value of the foramen area, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and processing the target expansion area, the target lamina displacement distance, the safe expansion value of the foramen area, and the implantation time of the target fusion device through a fusion trend prediction model to obtain a bone fusion risk value, wherein the bone fusion risk value is used to characterize the probability of fusion failure between the lamina and the target fusion device.
[0117] Optionally, if the target lamina displacement distance is greater than or equal to a distance threshold, a risk of collapse of the target fusion device is determined. In this case, a "lamina collapse risk" alarm can be sent to the physician's device terminal, without the need for bone fusion trend prediction. If the target lamina displacement distance is less than the distance threshold, a risk of collapse of the target fusion device is determined.
[0118] If the target fusion cage is confirmed to have no risk of collapse, the fusion risk between the cervical spine and the target fusion cage can be assessed to enable early identification of laminar stability. Optionally, the target processing system can obtain the safe expansion value of the foramen area, and then input the target expansion area, the actual postoperative laminar displacement (i.e., the target laminar displacement distance), the safe expansion value of the foramen area, and the postoperative duration (i.e., the implantation time of the target fusion cage) into the fusion trend prediction model. The fusion trend prediction model processes the data to obtain the bone fusion risk value. The bone fusion risk value is in the range of 0-1.
[0119] After determining the bone fusion risk value, corresponding prompts can be generated based on the numerical relationship between the bone fusion risk value and a preset risk threshold. For example, when the bone fusion risk value is <0.75, the prompt is "Good fusion trend"; when the bone fusion risk value is ≥0.75, the prompt is "It is recommended to strengthen follow-up or have a repeat CT scan in advance".
[0120] In an optional embodiment, the fusion trend prediction model is a neural network model. The fusion trend prediction model can be trained by a training sample set, in which the training samples are the sample expansion area of the sample user, the sample lamina displacement distance, the sample foramen area safe expansion value, and the implantation time of the sample fusion device. The real label corresponding to the training sample indicates whether the fusion between the lamina and the target fusion device is successful.
[0121] It should be noted that the above methods enable early identification of the stability between the fusion cage and the lamina and accurate prediction of bone fusion risks, thereby facilitating doctors to conduct postoperative management more promptly and accurately.
[0122] In an optional embodiment, the target processing system includes an individualized expansion parameter matching module, a data reading module, and a postoperative evaluation module. The individualized expansion parameter matching module processes preoperative imaging data, calculates the required foraminal area under normal spinal cord conditions, compares it with the pre-expansion foraminal area to obtain the target expansion area, and matches the fusion device's specifications based on the target expansion area to determine the target fusion device. The data reading module receives real-time monitoring data from sensors in the target fusion device. The postoperative evaluation module determines whether laminar collapse has occurred and whether bone graft fusion has occurred based on the real-time monitoring data.
[0123] Optionally, the individualized distraction parameter matching module may include an image processing unit and a parameter matching unit. The image processing unit extracts the areas of the first and second vertebral foramina from preoperative cervical MRI or CT images. The parameter matching unit calculates the target distraction area based on the difference between the areas of the first and second vertebral foramina and matches specifications such as the fusion cage length, distraction angle, and interlaminar spacing.
[0124] Optionally, the postoperative assessment module may include a risk prediction unit, which is used to predict the risk of lamina collapse or fusion failure based on real-time monitoring data, preoperative imaging parameters, and bone density information.
[0125] Therefore, the method provided in this application achieves the goal of dynamically selecting the fusion cage based on the actual vertebral foramen opening requirements of the patient's cervical spine, thereby improving the accuracy of fusion cage selection. It also solves the technical problem of low accuracy in selecting the fusion cage required for posterior cervical unilateral open laminoplasty, which relies on manual experience.
[0126] It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions, and although a logical order is shown in the flowchart, in some cases the steps shown or described may be executed in a different order than that shown here.
[0127] Example 2
[0128] According to an embodiment of this application, a fusion processor is also provided, which is determined based on the fusion processor selection method in Embodiment 1, such as... Figure 5 As shown, the fusion unit includes:
[0129] The fusion device body 1 has a bone graft cavity 2 that penetrates through the fusion device body 1.
[0130] Sensor 3 is embedded below the target end face 4 of the fusion body 1. The target end face 4 is the end face used to contact the vertebral lamina of the target object. The target end face 4 is provided with a thin-walled deformation area 41 covering the sensor 3. The thin-walled deformation area 41 deforms as the bone material in the bone graft cavity 2 fuses with the cervical vertebra. The sensor 3 is used to detect this deformation.
[0131] Optional, such as Figure 5 As shown, the fusion device body 1 can be a bridge-shaped or arc-shaped structure. A bone graft cavity 2 is provided on the fusion device body 1, penetrating the body. This cavity is used to fill bone fragments to promote bone fusion. The implantation method of the fusion device in the cervical spine in this embodiment can be referred to... Figure 4 The implantation method of the target fusion device is shown.
[0132] like Figure 5As shown, a sensor 3 is embedded at one end of the fusion unit 1, below the target end face 4 that is in contact with the cervical vertebral laminae. This sensor 3 is located below the target end face 4 and is covered by a specially designed thin-walled deformation zone 41 within the target end face 4. The thin-walled deformation zone 41 employs a deformable thin-walled structure. During the bone graft fusion process (i.e., the process of the bone material in the bone graft cavity 2 fusing with the vertebral laminae), this thin-walled structure deforms as the bone grows in, and this deformation is detected by the sensor 3. The sensor 3 is used to monitor postoperative displacement or stress changes between the vertebral laminae. The sensor 3 can be a strain gauge sensor or a piezoelectric sensor, and it can communicate with the data reading module of the target processing system via wireless inductive coupling, allowing the target processing system to obtain changes in the resistance value of the sensor 3.
[0133] In an alternative embodiment, the fusion body 1 may be made of titanium alloy.
[0134] In an optional embodiment, the fusion device body 1 has threaded holes 6 on both the left and right sides, extending from the top surface of the fusion device body 1 to the end face of the fusion device body 1, i.e., the end face that contacts the lamina of the target patient. After the fusion device is implanted into the patient, two non-locking screws pass through the threaded holes 6 on the left and right sides respectively to fix the fusion device to the lamina on both sides. During screwing, the screw heads generate axial pressure, thereby providing moderate pressure to the lamina. Due to the non-locking structure, there will be a small gap between the screw head and the threaded hole 6 of the fusion device, which can provide limited micromovement within ±0.2 to 0.5 mm after surgery, which is beneficial for bone ingrowth and fusion. Bone fragments are placed in the bone graft cavity 2 of the fusion device and compacted to complete the surgery.
[0135] In an optional embodiment, after the fusion device is implanted, a sensor 3 fixed inside the fusion device body 1 is used to monitor the micro-displacement between the vertebral laminae in real time. This sensor 3, after being insulated and encapsulated, is suitable for in vivo implantation and has a measurement range of 0-15 mm. The sensor 3 can be connected to an external data reading module via a coupling coil. The data reading module can be set to collect data from the sensor 3 once a day and automatically upload curve trend data once a week.
[0136] In this embodiment, the fusion device is determined using the fusion device selection method described in Embodiment 1. This enables dynamic selection of the fusion device based on the actual foraminal opening requirements of the target patient's cervical spine, thereby improving the accuracy of fusion device selection. By embedding sensors in the fusion device and covering it with a thin-walled deformation zone, accurate determination of the deformation data of the cervical lamina during the fusion process can be achieved. This facilitates subsequent accurate assessment of the progress of bone fusion, effectively warns of potential collapse and fusion failure risks, allows for timely intervention, avoids long-term complications caused by poor bone fusion, and improves surgical safety.
[0137] In an optional embodiment, an anti-slip structure 5 is provided on the target end face 4.
[0138] Optionally, the anti-slip structure 5 can be a toothed structure.
[0139] Optionally, the anti-slip structure 5 can be a dovetail groove structure.
[0140] For example, the end faces of both ends of the laminae fusion device body 1 are provided with interlocking teeth or dovetail groove structures to enhance stability, thereby increasing the friction between the fusion device body 1 and the lamina, and thus enhancing the stability between the fusion device and the lamina.
[0141] In an optional embodiment, the fusion device body 1 is provided with at least one scale structure or transillumination window structure for assisting in the measurement of interlaminar spacing in postoperative CT images.
[0142] It should be noted that by setting an anti-slip structure 5 on the target end face 4, the stability of the fusion device can be effectively enhanced.
[0143] Example 3
[0144] This application also provides a fusion selector device. It should be noted that the fusion selector device of this application can be used to execute the fusion selector method provided in this application. The fusion selector device provided in this application will be described below.
[0145] According to an embodiment of this application, an apparatus for implementing the above-described fusion selector method is also provided, such as... Figure 6 As shown, the device includes:
[0146] The first acquisition module 601 is used to acquire medical images of the cervical spine of the target object;
[0147] The first determining module 602 is used to determine the area of the first vertebral foramen of the cervical spine of the target object before the lesion and the area of the second vertebral foramen of the target object after the lesion based on cervical spine medical images.
[0148] The second determining module 603 is used to determine the target opening area of the vertebral foramen based on the area of the first vertebral foramen and the area of the second vertebral foramen.
[0149] The third determining module 604 is used to determine the fusion device parameters based on the target expansion area, and to determine the target fusion device from multiple fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the cervical vertebrae between the two lamina to expand the foramen area.
[0150] In this embodiment, the area of the first vertebral foramen in a healthy state and the area of the second vertebral foramen in a diseased state of the target object are determined based on the cervical spine medical image of the target object, and the target expansion area is determined accordingly. This achieves effective determination of the additional area that the fusion device needs to expand. By determining the fusion device parameters based on the target expansion area, and determining the target fusion device from multiple fusion devices based on the fusion device parameters, the target fusion device is dynamically selected based on the actual vertebral foramen expansion requirements of the target object's cervical spine, thereby improving the accuracy of fusion device selection.
[0151] Therefore, the method provided in this application achieves the goal of dynamically selecting the fusion cage based on the actual vertebral foramen opening requirements of the patient's cervical spine, thereby improving the accuracy of fusion cage selection. It also solves the technical problem of low accuracy in selecting the fusion cage required for posterior cervical unilateral open laminoplasty, which relies on manual experience.
[0152] Optionally, in the fusion device selection device provided in the embodiments of this application, the second determining module further includes: a first calculation submodule, used to calculate the difference between the area of the first vertebral foramen and the area of the second vertebral foramen to obtain the area difference; and a second calculation submodule, used to calculate the product of the area difference and the target coefficient to obtain the target expansion area, wherein the target coefficient is greater than 1.
[0153] Optionally, in the fusion device selection apparatus provided in the embodiments of this application, the third determining module further includes: a first obtaining submodule, used to obtain a preset mapping table, wherein the mapping table is used to record at least the mapping relationship between the expansion area and the fusion length; a first determining submodule, used to determine the fusion length matching the target expansion area from the mapping table, thereby obtaining the target fusion length; and a second determining submodule, used to determine the target fusion length as a fusion parameter.
[0154] Optionally, in the fusion device selection device provided in the embodiments of this application, the fusion device selection device further includes: a detection module, used to detect the target resistance change of the sensor in the target fusion device when the target fusion device has been implanted in the cervical spine of the target object; a fourth determination module, used to determine the target vertebral plate displacement distance matching the target resistance change based on the mapping relationship between the resistance change and the vertebral plate displacement distance; and a fifth determination module, used to determine whether the target fusion device has a risk of collapse based on the numerical relationship between the target vertebral plate displacement distance and the distance threshold.
[0155] Optionally, in the fusion device selection device provided in the embodiments of this application, the fusion device selection device further includes: a second acquisition module, used to acquire the safe expansion value of the foramen area, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and a sixth determination module, used to determine a distance threshold based on the target expansion area and the safe expansion value of the foramen area.
[0156] Optionally, in the fusion device selection device provided in this application embodiment, the sixth determining module further includes: a third determining submodule, used to determine the target vertebral foramen area based on the second vertebral foramen area and the target expansion area; a fourth determining submodule, used to determine a first coefficient based on the target vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area; a fifth determining submodule, used to determine a second coefficient based on the current vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area, wherein the current vertebral foramen area refers to the vertebral foramen area after the target fusion device is implanted into the cervical spine; a third calculation submodule, used to calculate a first product between the first coefficient and the target expansion area, and calculate a second product between the second coefficient and the safe expansion value of the vertebral foramen area; and a sixth determining submodule, used to determine a distance threshold based on the first product and the second product.
[0157] Optionally, in the fusion device selection device provided in the embodiments of this application, the fusion device selection device further includes: a third acquisition module, used to acquire a safe expansion value of the foramen area when it is determined that the target fusion device has no risk of collapse, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; and a processing module, used to process the target expansion area, the target lamina displacement distance, the safe expansion value of the foramen area, and the implantation time of the target fusion device through a fusion trend prediction model to obtain a bone fusion risk value, wherein the bone fusion risk value is used to characterize the probability of fusion failure between the lamina and the target fusion device.
[0158] It should be noted that the first acquisition module 301, the first determination module 302, the second determination module 303, and the third determination module 304 mentioned above correspond to steps S201 to S204 in Embodiment 1. The four modules and their corresponding steps implement the same instances and application scenarios, but are not limited to the content disclosed in Embodiment 1. It should be noted that the above modules or units can be hardware or software components stored in memory (e.g., memory 104) and processed by one or more processors (e.g., processors 102a, 102b, ..., 102n). The above modules can also be part of a device and run in the computer terminal 10 provided in Embodiment 1.
[0159] Example 4
[0160] Embodiments of this application may provide an electronic device. Figure 7 This is a structural block diagram of an electronic device according to an embodiment of this application. Figure 7 As shown, the electronic device may include: one or more ( Figure 7 (Only one is shown) processor 1002, memory 1004, memory controller, and peripheral interface, wherein the peripheral interface is connected to the radio frequency module, audio module and display.
[0161] The memory can be used to store software programs and modules, such as the program instructions / modules corresponding to the methods and apparatus in the embodiments of this application. The processor executes various functional applications and data processing by running the software programs and modules stored in the memory, thereby implementing the above-described methods. The memory may include high-speed random access memory, and may also include non-volatile memory, such as one or more magnetic storage devices, flash memory, or other non-volatile solid-state memory. In some instances, the memory may further include memory remotely located relative to the processor, and these remote memories can be connected to the terminal via a network. Examples of such networks include, but are not limited to, the Internet, corporate intranets, local area networks, mobile communication networks, and combinations thereof.
[0162] The processor can access information and applications stored in the memory via a transmission device to perform the following steps: acquiring medical images of the cervical spine of the target object; determining the area of the first vertebral foramen before the lesion and the area of the second vertebral foramen after the lesion based on the medical images of the cervical spine; determining the target expansion area of the vertebral foramen based on the areas of the first and second vertebral foramina; determining fusion device parameters based on the target expansion area, and determining the target fusion device from multiple fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the cervical spine between two lamina to expand the area of the vertebral foramen.
[0163] The processor can also call the information and application program stored in the memory through the transmission device to perform the following steps: calculate the difference between the area of the first vertebral foramen and the area of the second vertebral foramen to obtain the area difference; calculate the product of the area difference and the target coefficient to obtain the target expansion area, wherein the target coefficient is greater than 1.
[0164] The processor can also call the information and application stored in the memory through the transmission device to perform the following steps: obtain a preset mapping table, wherein the mapping table is used to record at least the mapping relationship between the expansion area and the fusion length; determine the fusion length that matches the target expansion area from the mapping table to obtain the target fusion length; and determine the target fusion length as the fusion parameter.
[0165] The processor can also call the information and application programs stored in the memory through the transmission device to perform the following steps: after determining the target fusion device from multiple fusion devices based on the fusion device parameters, and in the case that the target fusion device has been implanted in the cervical spine of the target object, detect the target resistance change of the sensor in the target fusion device; determine the target vertebral plate displacement distance matching the target resistance change based on the mapping relationship between the resistance change and the vertebral plate displacement distance; and determine whether the target fusion device has a risk of collapse based on the numerical relationship between the target vertebral plate displacement distance and the distance threshold.
[0166] The processor can also call the information and application programs stored in the memory through the transmission device to perform the following steps: before determining whether there is a risk of collapse of the target fusion device based on the numerical relationship between the target vertebral laminar displacement distance and the distance threshold, determine the target vertebral foramen area based on the second vertebral foramen area and the target expansion area; obtain the safe expansion value of the vertebral foramen area, wherein the safe expansion value of the vertebral foramen area represents the minimum expansion area threshold corresponding to the vertebral foramen; determine the distance threshold based on the target expansion area and the safe expansion value of the vertebral foramen area.
[0167] The processor can also call the information and application stored in the memory through the transmission device to perform the following steps: determining a first coefficient based on the target vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area; determining a second coefficient based on the current vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area, wherein the current vertebral foramen area refers to the vertebral foramen area after the target fusion device is implanted into the cervical spine; calculating a first product between the first coefficient and the target expansion area, and calculating a second product between the second coefficient and the safe expansion value of the vertebral foramen area; determining a distance threshold based on the first product and the second product.
[0168] The processor can also call the information and application programs stored in the memory through the transmission device to perform the following steps: after determining whether there is a risk of collapse of the target fusion device, and if it is determined that there is no risk of collapse of the target fusion device, obtain the safe expansion value of the foramen area, where the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen; process the target expansion area, the target lamina displacement distance, the safe expansion value of the foramen area, and the implantation time of the target fusion device through the fusion trend prediction model to obtain the bone fusion risk value, where the bone fusion risk value is used to characterize the probability of fusion failure between the lamina and the target fusion device.
[0169] Those skilled in the art will understand that Figure 7 The structure shown is for illustrative purposes only. Electronic devices can also be smartphones, tablets, handheld computers, mobile internet devices (MIDs), PADs, and other terminal devices. Figure 7 This does not limit the structure of the aforementioned electronic device. For example, electronic devices may also include components that are more... Figure 7 The more or fewer components shown (such as network interfaces, display devices, etc.), or having the same Figure 7 The different configurations shown.
[0170] Those skilled in the art will understand that all or part of the steps in the various methods of the above embodiments can be implemented by a program instructing the hardware related to the terminal device. The program can be stored in a computer-readable storage medium, which may include: flash drive, read-only memory (ROM), random access memory (RAM), disk or optical disk, etc.
[0171] Example 5
[0172] Embodiments of this application also provide a storage medium. Optionally, in this embodiment, the storage medium can be used to store the program code executed by the fusion selection method provided in Embodiment 1.
[0173] Optionally, in this embodiment, the storage medium may be located in any computer terminal in a group of computer terminals in a computer network, or in any mobile terminal in a group of mobile terminals.
[0174] This application also provides a computer program product, which, when executed on a data processing device, is adapted to perform the selection method steps of a fusion processor.
[0175] The sequence numbers of the embodiments in this application are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.
[0176] In the above embodiments of this application, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments.
[0177] In the several embodiments provided in this application, it should be understood that the disclosed technical content can be implemented in other ways. The device embodiments described above are merely illustrative; for example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection of units or modules may be electrical or other forms.
[0178] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.
[0179] Furthermore, the functional units in the various embodiments of this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit.
[0180] If the integrated unit is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or all or part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as a USB flash drive, read-only memory (ROM), random access memory (RAM), portable hard drive, magnetic disk, or optical disk.
[0181] The above description is only a preferred embodiment of this application. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this application, and these improvements and modifications should also be considered within the scope of protection of this application.
Claims
1. A method for selecting a fusion processor, characterized in that, include: Acquire medical images of the cervical spine of the target subject; Based on the cervical spine medical images, determine the area of the first vertebral foramen of the target object before the lesion and the area of the second vertebral foramen of the target object after the lesion; The target opening area of the vertebral foramen is determined based on the area of the first vertebral foramen and the area of the second vertebral foramen. The fusion device parameters are determined based on the target expansion area, and a target fusion device is determined from multiple fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the cervical vertebrae of the target object between two lamina to expand the foraminal area; After determining the target fusion unit from multiple fusion units based on the fusion unit parameters, the method further includes: In the case where the target fusion device has been implanted in the cervical spine of the target patient, the change in target resistance of the sensor in the target fusion device is detected; Based on the mapping relationship between the change in resistance and the displacement distance of the vertebral plate, the target vertebral plate displacement distance matching the target change in resistance is determined; Based on the numerical relationship between the target lamina displacement distance and the distance threshold, it is determined whether the target fusion device has a risk of collapse; Before determining whether the target fusion device has a risk of collapse based on the numerical relationship between the target lamina displacement distance and the distance threshold, the method further includes: Obtain the safe expansion value of the vertebral foramen area, wherein the safe expansion value of the vertebral foramen area represents the minimum expansion area threshold corresponding to the vertebral foramen; The distance threshold is determined based on the target expansion area and the safe expansion value of the vertebral foramen area; Determining the distance threshold based on the target expansion area and the safe expansion value of the vertebral foramen area includes: The target vertebral foramen area is determined based on the area of the second vertebral foramen and the target expansion area; A first coefficient is determined based on the target vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the target vertebral foramen area. A second coefficient is determined based on the current vertebral foramen area and the longitudinal diameter of the vertebral foramen corresponding to the current vertebral foramen area, wherein the current vertebral foramen area refers to the vertebral foramen area after the target fusion device is implanted into the cervical spine; Calculate the first product between the first coefficient and the target expansion area, and calculate the second product between the second coefficient and the safe expansion value of the vertebral foramen area; The distance threshold is determined based on the first product and the second product.
2. The method according to claim 1, characterized in that, Determining the target opening area of the vertebral foramen based on the area of the first vertebral foramen and the area of the second vertebral foramen includes: Calculate the difference between the area of the first vertebral foramen and the area of the second vertebral foramen to obtain the area difference; The target expanded area is obtained by multiplying the area difference by the target coefficient, wherein the target coefficient is greater than 1.
3. The method according to claim 1, characterized in that, Determining the fusion unit parameters based on the target expanded area includes: Obtain a preset mapping table, wherein the mapping table is used at least to record the mapping relationship between the expansion area and the fusion length; The target fusion length is obtained by determining the fusion length that matches the target expanded area from the mapping table; The target fusion length is determined as the fusion parameter.
4. The method according to claim 1, characterized in that, After determining whether the target fusion device is at risk of collapse, the method further includes: If it is determined that the target fusion device does not have the risk of collapse, the safe expansion value of the foramen area is obtained, wherein the safe expansion value of the foramen area represents the minimum expansion area threshold corresponding to the foramen. The bone fusion risk value is obtained by processing the target expansion area, the target lamina displacement distance, the safe expansion value of the vertebral foramen area, and the implantation time of the target fusion device through a fusion trend prediction model. The bone fusion risk value is used to characterize the probability of fusion failure between the lamina and the target fusion device.
5. A fusion device, characterized in that, The fusion unit is determined based on the method according to any one of claims 1 to 4, and the fusion unit comprises: The fusion device body (1) has a bone graft cavity (2) that penetrates the fusion device body (1). The sensor (3) is embedded below the target end face (4) of the fusion body (1). The target end face (4) is the end face for contacting the vertebral lamina of the target object. The target end face (4) is provided with a thin-walled structural deformation area (41) covering the sensor (3). The thin-walled structural deformation area (41) deforms as the bone material in the bone graft cavity (2) fuses with the cervical vertebra. The sensor (3) is used to detect this deformation.
6. The fusion device according to claim 5, characterized in that, An anti-slip structure (5) is provided on the target end face (4).
7. A selection device for a fusion unit, characterized in that, For performing the method according to any one of claims 1 to 4, comprising: The first acquisition module is used to acquire medical images of the cervical spine of the target object; The first determining module is used to determine the area of the first vertebral foramen of the cervical spine of the target object before the lesion and the area of the second vertebral foramen of the target object after the lesion, based on the cervical spine medical image. The second determining module is used to determine the target opening area of the vertebral foramen based on the area of the first vertebral foramen and the area of the second vertebral foramen. The third determining module is used to determine the fusion device parameters based on the target expansion area, and to determine the target fusion device from multiple fusion devices based on the fusion device parameters, wherein the target fusion device is used to support the two lamina of the cervical vertebrae of the target object to expand the foramen area.
8. A computer-readable storage medium, characterized in that, The computer-readable storage medium includes a stored executable program, wherein, when the executable program is executed, it controls the device on which the computer-readable storage medium is located to perform the fusion selection method according to any one of claims 1 to 4.
9. An electronic device, characterized in that, include: Memory, which stores executable programs; A processor for running the program, wherein the program, when running, executes the fusion selection method according to any one of claims 1 to 4.
Citation Information
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