Device and system implanted outside epidural under ultrasonic guidance and used for temporary electrode stimulation of spinal cord

Abstract

The invention provides a device and system implanted outside epidural under ultrasonic guidance for temporary electrode stimulation of spinal cord, and the device comprises a risk assessment module which carries out the comprehensive assessment of a patient through a multi-modal risk assessment model, and outputs a risk level or probability; the configuration selection module is used for analyzing the parameter information of the patient according to the parameter information of the patient when the evaluation result is passed, and setting guide configuration requirements; the probe guiding module guides the temporary electrode through an ultrasonic thermodynamic diagram; the effect test module is used for testing electrode functions by using a stimulator and adjusting electrode positions; the fixing and closing module fixes the electrode to avoid displacement; and the recording and monitoring module is used for recording electrode implantation depth, stimulation parameters and patient response. The system can reduce invasiveness and ultrasonic guidance accurate positioning, reduces errors and complications, is easy to popularize and apply, is relatively simple to operate, and is suitable for being popularized and applied in more medical places.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a device and system for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance. Background Art

[0002] Traditional EES technology mainly stimulates by surgically implanting electrodes. It has the disadvantage of large surgical trauma. Since traditional EES requires surgical implantation of electrodes, the surgical trauma is large, and there are risks such as postoperative infection and displacement. Moreover, there are long-term use risks. Implantable electrodes may cause long-term complications, such as electrode displacement, electrode fracture or infection. At the same time, the operation is not flexible. Although some studies have shown that EES is effective in restoring motor function, its curative effect is still unstable, and long-term use is required to observe significant effects, and dynamic adjustment cannot be achieved.

[0003] Therefore, designing a device with good stimulation guidance effect, simple operation, effective in improving sensory function and reducing muscle spasm, without surgery, and reducing the risk of invasive operations is an important content for those skilled in the art to study. Summary of the Invention

[0004] In view of this, it is necessary to provide a device and system for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance, including a risk assessment module that comprehensively assesses a patient through a multimodal risk assessment model and outputs a risk level or probability; a configuration selection module that, when the assessment result is passed, analyzes the patient parameter information to set the guiding configuration requirements according to the patient parameter information; a probe guiding module that guides the temporary electrode through an ultrasonic thermogram; an effect testing module that tests the electrode function using a stimulator and adjusts the electrode position; a fixing and sealing module that fixes the electrode to avoid displacement; a recording and monitoring module that records the electrode implantation depth, stimulation parameters and patient responses. It can reduce invasiveness, accurately locate under ultrasonic guidance, reduce errors and complications, is easy to promote and apply, has a relatively simple operation, and is suitable for promotion and application in more medical places.

[0005] In response to the above problems, the present invention proposes a percutaneous epidural temporary electrode stimulation (EES), which uses a temporary electrode under ultrasonic guidance as a temporary electrode for short-term epidural electrical stimulation. This method does not require surgery, reduces the risk of invasive operations, and preliminary studies show that it is effective in improving sensory function and reducing muscle spasm.

[0006] It can at least overcome one of the above defects.

[0007] In a first aspect, an embodiment of the present application provides a device for implanting an epidural temporary electrode for spinal cord stimulation under ultrasound guidance. The device includes a risk assessment module, a configuration selection module, a probe guidance module, an effect test module, a fixation and sealing module, and a recording and monitoring module. Each module is connected to a control device, and the control device is used to control and implement the functions of each module. Among them,

[0008] The risk assessment module is used to obtain the patient's medical data, comprehensively evaluate the patient through a multimodal risk assessment model, and output a risk level or probability;

[0009] The configuration selection module is used to, when the evaluation result is passed, analyze the guiding configuration requirements according to the patient parameter information, and the guiding configuration requirements include an ultrasound probe and a temporary electrode;

[0010] The probe guidance module is used to guide the temporary electrode through an ultrasound thermogram, so that the temporary electrode moves in the trajectory direction of the ultrasound thermogram to ensure that the needle tip approaches the target position. The ultrasound thermogram is obtained from the images of the spinal anatomy structure and the epidural space displayed by the guiding probe;

[0011] The effect test module is used to test the electrode function using a stimulator, observe the patient's feedback, and adjust the electrode position until the best effect is achieved;

[0012] The fixation and sealing module is used to pull out the stylet and leave the electrode, ensure that the electrode is placed smoothly along the spinal direction. If the test is passed, fix the electrode to avoid displacement, and cover the puncture site with a sterile dressing;

[0013] The recording and monitoring module is used to record the electrode implantation depth, stimulation parameters, and the patient's response, and closely observe the patient's postoperative conditions, including whether there is infection, bleeding, or other complications.

[0014] Optionally, in another implementation manner of the first aspect of the present invention, the multimodal risk assessment model is constructed in the following manner:

[0015] S1.1: Collect medical record sample data from a local database. The medical record sample data includes text data and image data in electronic medical records;

[0016] S1.2: Classify and preprocess the sample data to obtain effective standard data;

[0017] S1.3: Use the principal component PCA analysis method to perform data dimensionality reduction and feature extraction on the preprocessed text sample data set; use the CNN network model to perform feature extraction on the preprocessed image sample data set;

[0018] S1.4: Divide the extracted data into a training set and a validation set, train a text classification model using the text feature training set, and train an image classification model using the training set image features;

[0019] S1.4: In the decision-making stage, fuse the outputs of the text classification model and the image classification model;

[0020] S1.5: Use the validation set to validate the fused text classification model and image classification model, and use cross-validation to evaluate the model performance to obtain a multimodal risk assessment model.

[0021] Optionally, in another implementation manner of the first aspect of the present invention, the loss function of the multimodal risk assessment model is:

[0022]

[0023] where N is the number of samples, C is the number of categories, p i,c is the probability that the i-th sample predicted by the model belongs to category c, and y i,c is the true label of the i-th sample, the predicted value of the model for the i-th sample, and α and β are the weight ratios respectively.

[0024] Optionally, in another implementation manner of the first aspect of the present invention, the ultrasonic thermogram is obtained from the images of the spinal anatomical structure and the epidural space displayed by the guiding probe, including:

[0025] Generate an image using the reflection and propagation characteristics of ultrasonic waves in tissues;

[0026] Display the signal intensity or temperature distribution of different regions through color changes;

[0027] Convert the original image into a thermogram to highlight the epidural space and its surrounding structures;

[0028] Form a thermogram guiding trajectory according to the thermogram trend and display it in a split screen for visualization.

[0029] Optionally, in another implementation manner of the first aspect of the present invention, the probe guiding module is further used for:

[0030] Slowly insert the combined electrode assembly along the direction of the thermogram guiding trajectory into the skin, and gradually advance under the guidance of the thermogram guiding trajectory to ensure that the tip of the needle approaches the target position;

[0031] During the operation, the operator holds the ultrasonic probe with one hand to display the images of the spinal anatomical structure and the epidural space by the guiding probe, and holds the temporary electrode with the other hand to insert the needle along the ultrasonic-guided trajectory.

[0032] Optionally, in another implementation manner of the first aspect of the present invention, the risk assessment module is further configured to:

[0033] Conduct a comprehensive assessment of the patient to ensure that they are suitable for electrode implantation operations, including assessing the medical history, spinal structure, and related diseases.

[0034] Optionally, in another implementation manner of the first aspect of the present invention, the recording and monitoring are further configured to:

[0035] The needle implantation range is bilateral on the posterior midline, at the T11 / T12, T12 / L1, and L1 / L2 intervertebral spaces. Leave 1 electrode at each vertebral interspace on each side, for a total of 6 needles left.

[0036] Connect the negative electrode to the positive electrode from the inside to the outside, and set the parameters as follows: frequency 10HZ, current intensity 0 - 5mA, time 60min, pulse width 1ms;

[0037] And make fine adjustments according to the patient's feedback.

[0038] In a second aspect, an embodiment of the present application provides a system for implanting an epidural temporary electrode for spinal cord stimulation under ultrasound guidance. Applied to the device for implanting an epidural temporary electrode for spinal cord stimulation under ultrasound guidance as described in the first aspect, it further includes

[0039] An ultrasound electronic system, a puncture needle tube, and an ultrasound transducer;

[0040] The ultrasound electronic system is connected to the ultrasound transducer;

[0041] The main body of the puncture needle tube is, from the inside to the outside, a stylet, a metal braided sleeve, and an outer plastic sleeve. The head end of the needle tube main body is a needle-shaped metal head, which is connected to the plastic sleeve and the metal braided sleeve; the tail end of the main body is a power transfer female head, which is connected to the metal sleeve and the plastic sleeve of the main body.

[0042] Optionally, in another implementation manner of the second aspect of the present invention, the plastic sleeve is a hard plastic sleeve.

[0043] Optionally, in another implementation manner of the second aspect of the present invention, the specific operation of the puncture needle tube is as follows

[0044] Insert the stylet into the metal sleeve to form Assembly 1;

[0045] Insert Assembly 1 into the hard plastic sleeve again to form Assembly 2;

[0046] When in use, align it with the specific position, hold the hard plastic sleeve, tap the tail end of the stylet, the needle tip can penetrate the skin, and after adjusting the depth, pull out the stylet;

[0047] The plastic sleeve part of the electrode is made of a soft material, bends together with the metal braided sleeve, and the tail end is connected to the adapter of the therapeutic instrument.

[0048] In the technical solution provided by the present invention, there is provided a device for implanting an epidural temporary electrode to stimulate the spinal cord under ultrasonic guidance. The device includes a risk assessment module, a configuration selection module, a probe guidance module, an effect test module, a fixation and sealing module, and a recording and monitoring module. Each module is connected to a control device, and the control device is used to control and implement the functions of each module. Among them, the risk assessment module is used to obtain the medical data of the patient, comprehensively evaluate the patient through a multi-modal risk assessment model, and output a risk level or probability; the configuration selection module is used to, when the evaluation result is passed, analyze the guiding configuration requirements according to the patient parameter information, and the guiding configuration requirements include an ultrasonic probe and a temporary electrode; the probe guidance module is used to guide the temporary electrode through an ultrasonic thermogram, so that the temporary electrode moves in the trajectory direction of the ultrasonic thermogram to ensure that the needle tip approaches the target position, and the ultrasonic thermogram is obtained from the images of the spinal anatomical structure and the epidural space displayed by the guiding probe; the effect test module is used to test the electrode function with a stimulator, observe the patient's feedback, and adjust the electrode position until the best effect is achieved; the fixation and sealing module is used to pull out the stylet and leave the electrode, ensure that the electrode is placed smoothly along the direction of the spine, fix the electrode to avoid displacement if the test is passed, and cover the puncture site with a sterile dressing; the recording and monitoring module is used to record the electrode implantation depth, stimulation parameters and patient responses, and closely observe the patient's postoperative conditions, including whether there is infection, bleeding or other complications.

[0049] Advantageous effects:

[0050] (1) Reduced invasiveness: The present invention uses a temporary electrode to replace the traditional implantable electrode, avoiding the trauma and risks associated with surgery.

[0051] (2) Precise positioning under ultrasonic guidance: Through ultrasonic guidance, the insertion site of the temporary electrode can be precisely positioned, reducing errors and complications.

[0052] (3) Easy to promote and apply: Since no surgery is required and the operation is relatively simple, it is suitable for promotion and application in more medical facilities. Description of the Drawings

[0053] Figure 1 It is a schematic diagram of the device module for implanting an epidural temporary electrode to stimulate the spinal cord under ultrasonic guidance provided by an embodiment of the present application.

[0054] Figure 2 It is a schematic diagram of the puncture needle tube provided by an embodiment of the present application.

[0055] Figure 3The operation flow chart of the puncture needle tube provided by an embodiment of the present application. Detailed implementation manners

[0056] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments.

[0057] It should be noted that in the embodiments of the present application, "at least one" means one or more, and "a plurality" means two or more. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used in the description of this application are only for the purpose of describing specific embodiments, and are not intended to limit this application.

[0058] It should be noted that in the embodiments of the present application, terms such as "first" and "second" are only used for the purpose of distinguishing descriptions, and cannot be understood as indicating or implying relative importance, nor can they be understood as indicating or implying an order. Features defined with "first" and "second" may explicitly or implicitly include one or more of the described features. In the description of the embodiments of this application, words such as "exemplary" or "for example" are used to mean serving as an example, illustration, or description. Any embodiment or design solution described as "exemplary" or "for example" in the embodiments of this application should not be construed as being more preferred or having more advantages than other embodiments or design solutions. Rather, the use of words such as "exemplary" or "for example" is intended to present related concepts in a specific manner.

[0059] All other embodiments obtained by those of ordinary skill in the art based on the embodiments of this application without creative efforts fall within the scope of protection of this application.

[0060] Embodiment 1

[0061] The present application provides a device and system for implanting an epidural temporary electrode for spinal cord stimulation under ultrasonic guidance, including a risk assessment module, a configuration selection module, a probe guidance module, an effect test module, a fixation and sealing module, and a recording and monitoring module. Each module is connected to a control device, and the control device is used to control and implement the functions of each module. Among them, the risk assessment module is used to obtain patient medical data, comprehensively evaluate the patient through a multimodal risk assessment model, and output a risk level or probability; the configuration selection module is used to, when the evaluation result is passed, analyze the guiding configuration requirements according to the patient parameter information, and the guiding configuration requirements include an ultrasonic probe and a temporary electrode; the probe guidance module is used to guide the temporary electrode through an ultrasonic thermogram, so that the temporary electrode moves in the trajectory direction of the ultrasonic thermogram to ensure that the needle tip approaches the target position, and the ultrasonic thermogram is obtained from the images of the spinal anatomical structure and the epidural space displayed by the guiding probe; the effect test module is used to test the electrode function using a stimulator, observe the patient's feedback, and adjust the electrode position until the best effect is achieved; the fixation and sealing module is used to pull out the stylet and leave the electrode, ensure that the electrode is placed smoothly along the spinal direction, fix the electrode to avoid displacement if the test is passed, and cover the puncture site with a sterile dressing; the recording and monitoring module is used to record the electrode implantation depth, stimulation parameters, and patient responses, and closely observe the patient's postoperative conditions, including whether there is infection, bleeding, or other complications. It can reduce invasiveness, use a temporary electrode instead of a traditional implantable electrode, and avoid surgery-related traumas and risks. It can achieve precise positioning under ultrasonic guidance. Through ultrasonic guidance, the insertion site of the temporary electrode can be precisely located, reducing errors and complications. It is easy to promote and apply. Since no surgery is required and the operation is relatively simple, it is suitable for promotion and application in more medical venues.

[0062] Figure 1 It is a schematic diagram of the device module for implanting an epidural temporary electrode for spinal cord stimulation under ultrasonic guidance provided by an embodiment of the present application.

[0063] As Figure 1 shown, a device for implanting an epidural temporary electrode for spinal cord stimulation under ultrasonic guidance includes a risk assessment module 11, a configuration selection module 12, a probe guidance module 13, an effect test module 14, a fixation and sealing module 15, and a recording and monitoring module 16. Each module is connected to a control device 10, and the control device 10 is used to control and implement the functions of each module. Among them,

[0064] The risk assessment module 11 is used to obtain patient medical data, comprehensively evaluate the patient through a multimodal risk assessment model, and output a risk level or probability.

[0065] It can be understood that in this embodiment, the multimodal risk assessment model is constructed in the following manner:

[0066] S1.1: Collect medical record sample data from the local database, where the medical record sample data includes text data and image data in the electronic medical record;

[0067] S1.2: Classify and preprocess the sample data to obtain effective standard data;

[0068] S1.3: Use the principal component PCA analysis method to reduce the dimension and extract features from the preprocessed text sample data set; use the CNN network model to extract features from the preprocessed image sample data set;

[0069] S1.4: Divide the extracted data into a training set and a validation set, and use the text feature training set to train the text classification model, and use the training set image features to train the image classification model;

[0070] S1.4: In the decision-making stage, fuse the outputs of the text classification model and the image classification model;

[0071] S1.5: Use the validation set to verify the fused text classification model and image classification model, and use cross-validation to evaluate the model performance to obtain a multi-modal risk assessment model.

[0072] The loss function of the multi-modal risk assessment model is:

[0073]

[0074] where N is the number of samples, C is the number of classes, p i,c is the probability that the i-th sample predicted by the model belongs to class c, and y i,c is the true label of the i-th sample, the predicted value of the model for the i-th sample, and α and β are the weight ratios respectively.

[0075] It can be understood that in this embodiment, 80% of the data is used as the training set, and 20% of the data is used as the validation set to develop multiple machine learning models; among them, the selected machine learning algorithms can also include the RandomForest algorithm, the support vector machine SVM algorithm, the linear discriminant analysis LDA algorithm, and the extreme gradient boosting algorithm.

[0076] It can be understood that in this embodiment, the risk assessment module 11 is further configured to:

[0077] Conduct a comprehensive assessment of the patient to ensure that he / she is suitable for electrode implantation operations, including assessing the medical history, spinal structure, and related diseases.

[0078] A configuration selection module 12 is used to analyze the guiding configuration requirements for setting based on patient parameter information when the evaluation result is passed. The guiding configuration requirements include an ultrasonic probe and a temporary electrode.

[0079] It can be understood that in this embodiment, first, a comprehensive evaluation of the patient is performed to ensure that the patient is suitable for this operation. The medical history, spinal structure, and related diseases such as coagulation disorders or previous surgical history are evaluated. At the same time, the patient is communicated with to ensure that the patient understands the operation steps and potential risks and gives informed consent. Equipment preparation before the operation: Select a suitable ultrasonic probe for precise imaging of the spine and epidural space, and select a suitable temporary electrode to ensure that its length and diameter are suitable for entering the epidural. Prepare sterile gloves, disinfectants (such as povidone-iodine or alcohol), and sterile covers.

[0080] A probe guiding module 13 is used to guide the temporary electrode through an ultrasonic thermogram, so that the temporary electrode moves in the direction of the trajectory of the ultrasonic thermogram to ensure that the tip of the needle approaches the target position. The ultrasonic thermogram is obtained from the images of the spinal anatomy structure and the epidural space displayed by the guiding probe.

[0081] The patient usually takes a lateral or prone position, and the body position is appropriately adjusted to expose the spine well, and the target area is located by ultrasound. During the operation, the operator holds the ultrasonic probe with one hand to display the images of the spinal anatomy structure and the epidural space by the guiding probe, and holds the temporary electrode with the other hand to insert the needle along the trajectory guided by the ultrasound.

[0082] It can be understood that in this embodiment, the ultrasonic thermogram is obtained from the images of the spinal anatomy structure and the epidural space displayed by the guiding probe, including:

[0083] Generating an image by using the reflection and propagation characteristics of ultrasonic waves in tissues;

[0084] Displaying the signal intensity or temperature distribution of different regions through color changes;

[0085] Converting the original image into a thermogram to highlight the epidural space and its surrounding structures;

[0086] Forming a thermogram guiding trajectory according to the trend of the thermogram and displaying it in a split screen for visualization.

[0087] It can be understood that in this embodiment, the probe guiding module 13 is further used for:

[0088] Slowly inserting the combined electrode assembly into the skin along the direction of the thermogram guiding trajectory and gradually advancing it under the guidance of the thermogram guiding trajectory to ensure that the tip of the needle approaches the target position;

[0089] During the operation, the operator holds the ultrasound probe with one hand to guide the probe to display the spinal anatomical structure and the image of the epidural space, and holds the temporary electrode with the other hand to insert the needle along the trajectory guided by the ultrasound.

[0090] The effect test module 14 is used to test the electrode function using a stimulator, observe the patient's feedback, and adjust the electrode position until the best effect is achieved.

[0091] It can be understood that in this embodiment, the electrode function is tested using a stimulator, and the patient's feedback (such as numbness and muscle contraction) is observed. The electrode position is adjusted until the best effect is achieved.

[0092] The fixation and sealing module 15 is used to pull out the stylet, leaving the electrode, ensure that the electrode is placed smoothly along the spinal direction. If the test passes, fix the electrode to avoid displacement, and cover the puncture site with a sterile dressing.

[0093] It can be understood that in this embodiment, the stylet is pulled out, leaving the electrode. Epidural implantation: Ensure that the electrode is placed smoothly along the spinal direction. If the test passes, fix the electrode to avoid displacement. Cover the puncture site with a sterile dressing.

[0094] The recording and monitoring module 16 is used to record the electrode implantation depth, stimulation parameters and patient responses, and closely observe the patient's postoperative conditions, including whether there is infection, bleeding or other complications.

[0095] It can be understood that in this embodiment, the recording and monitoring 16 is also used for:

[0096] The needle implantation range is bilateral along the posterior median line, at the T11 / T12, T12 / L1, L1 / L2 intervertebral spaces. One electrode is left at each vertebral interspace on each side, and a total of 6 needles are left;

[0097] Connect the negative electrode to the positive electrode from the inside to the outside, and the parameter settings are: frequency 10HZ, current intensity 0 - 5mA, time 60min, pulse width 1ms;

[0098] And make fine adjustments according to the patient's feedback.

[0099] Embodiment 2

[0100] This application provides a system for implanting an epidural temporary electrode to stimulate the spinal cord under ultrasound guidance, which is applied to the device for implanting an epidural temporary electrode to stimulate the spinal cord under ultrasound guidance as described in Embodiment 1, and further includes:

[0101] An ultrasound electronic system, a puncture needle tube and an ultrasound transducer;

[0102] The ultrasound electronic system is connected to the ultrasound transducer.

[0103] Figure 2Schematic diagram of a puncture needle tube provided by an embodiment of the present application. As Figure 2 shown, the main body of the puncture needle tube includes a needle core, a metal braided sleeve, and an outer plastic sleeve from inside to outside. The head end of the needle tube main body is a needle-shaped metal head, which is connected to the plastic sleeve and the metal braided sleeve. The tail end of the main body is a power transfer female head, which is connected to the metal sleeve and the plastic sleeve of the main body.

[0104] It can be understood that in this embodiment, the plastic sleeve is a hard plastic sleeve.

[0105] Figure 3 Flowchart of the operation of the puncture needle tube provided by an embodiment of the present application. It can be understood that in this embodiment, the specific operation of the puncture needle tube is as follows:

[0106] S100, insert the needle core into the metal sleeve to form assembly 1;

[0107] S200, insert assembly 1 into the hard plastic sleeve again to form assembly 2;

[0108] S300, when in use, align it with the specific position, pinch the hard plastic sleeve, tap the tail end of the needle core, the needle tip can penetrate the skin, after adjusting the depth, pull out the needle core;

[0109] S400, the electrode plastic sleeve part is made of a soft material, bends together with the metal braided sleeve, and the tail end is connected to the interface of the therapeutic instrument.

[0110] It can be understood that in this embodiment, the percutaneous implanted temporary electrode is used as a device for short-term stimulation: using the temporary electrode as an electrode for short-term epidural electrical stimulation. The electrode positioning technology under ultrasound guidance: accurately positioning the insertion position of the temporary electrode under ultrasound guidance to improve the accuracy and safety of treatment. The optimization scheme of electrical stimulation parameters: adopting specific parameters (such as a current of 120 mA, a frequency of 100 kHz, and continuous wave stimulation for 60 minutes) to ensure the treatment effect.

[0111] It can be understood that in this embodiment, the present invention can reduce invasiveness. The present invention uses a temporary electrode instead of a traditional implanted electrode, avoiding the trauma and risks related to surgery. Ultrasound-guided precise positioning, through ultrasound guidance, the insertion site of the temporary electrode can be accurately positioned, reducing errors and complications. Easy to promote and apply, because no surgery is required and the operation is relatively simple, it is suitable for promotion and application in more medical places.

[0112] In an embodiment of the present application, the device involved is an electronic device, and the program operating in the electronic device can be a program that controls a Central Processing Unit (CPU) and other components to implement the functions of the above-described embodiments related to a solution of the present invention (a program that enables a computer to function). Then, the information processed by these devices is temporarily stored in a Random Access Memory (RAM) during its processing, and then stored in various ROMs such as a Read Only Memory (Flash ROM), a Hard Disk Drive (HDD), etc. It is read, corrected, and written by the CPU as needed.

[0113] It should be noted that a part of the electronic device of the above-described embodiment can also be implemented by a computer. In this case, the program for implementing the control function can be recorded on a computer-readable recording medium, and is implemented by reading the program recorded on the recording medium into the computer and executing it.

[0114] It should be noted that the "computer" mentioned here refers to a computer built into the electronic device, which is a computer including hardware such as an OS and peripheral devices. In addition, the "computer-readable recording medium" refers to removable media such as a floppy disk, a magneto-optical disk, a ROM, a CD-ROM, and a storage device such as a hard disk built into the computer.

[0115] Moreover, the "computer-readable recording medium" can include: a medium that dynamically stores a program for a short time, such as a communication line when transmitting a program via a network such as the Internet or a communication line such as a telephone line; a medium that stores a program for a fixed time, such as a volatile memory inside a computer of a server or a client in this case. In addition, the above program can be a program for implementing a part of the above functions, and can also be a program that can implement the above functions by combining with a program already recorded in the computer.

[0116] In addition, the electronic device in the above-described embodiment can also be implemented as an aggregate (device group) composed of multiple devices. Each device constituting the device group can have all or part of the functions or functional blocks of the electronic device in the above-described embodiment. As the device group, it only needs to have all the functions or functional blocks of the electronic device.

[0117] Those of ordinary skill in the art of the present technology should recognize that the above embodiments are only used to illustrate the present application, rather than to limit the present application. As long as it is within the scope of the spirit of the present application, appropriate changes and variations made to the above embodiments fall within the scope of protection required by the present application.

Claims

1. An apparatus for implanting an epidural temporary electrode for spinal cord stimulation under ultrasonic guidance, characterized in that, The device includes a risk assessment module, a configuration selection module, a probe guidance module, an effect test module, a fixation and sealing module, and a recording and monitoring module. Each module is connected to a control device, which is used to control and implement the functions of each module. Among them, The risk assessment module is used to obtain patient medical data, comprehensively evaluate the patient through a multi-modal risk assessment model, and output a risk level or probability; The configuration selection module is used to analyze the guiding configuration requirements according to the patient parameter information when the evaluation result is passed. The guiding configuration requirements include an ultrasonic probe and a temporary electrode; The probe guidance module is used to guide the temporary electrode through an ultrasonic thermogram, so that the temporary electrode moves in the trajectory direction of the ultrasonic thermogram to ensure that the needle tip approaches the target position. The ultrasonic thermogram is obtained from the images of the spinal anatomical structure and the epidural space displayed by the guiding probe; The effect test module is used to test the electrode function using a stimulator, observe the patient's feedback, and adjust the electrode position until the best effect is achieved; The fixation and sealing module is used to pull out the needle core, leave the electrode, ensure that the electrode is placed smoothly along the spinal direction, fix the electrode to avoid displacement if the test passes, and cover the puncture site with a sterile dressing; The recording and monitoring module is used to record the electrode implantation depth, stimulation parameters, and patient responses, and closely observe the patient's postoperative conditions, including whether there is infection, bleeding, or other complications.

2. An apparatus for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance according to claim 1, characterized in that, The multi-modal risk assessment model is constructed in the following way: S1.1: Collect medical record sample data from the local database. The medical record sample data includes text data and image data in the electronic medical record; S1.2: Classify and preprocess the sample data to obtain effective standard data; S1.3: Use the principal component PCA analysis method to perform data dimensionality reduction and feature extraction on the preprocessed text sample data set; Use the CNN network model to extract features from the preprocessed image sample data set; S1.4: Divide the extracted data into a training set and a validation set, use the text feature training set to train the text classification model, and use the training set image features to train the image classification model; S1.4: Fusion the outputs of the text classification model and the image classification model in the decision-making stage; S1.5: Use the validation set to validate the fused text classification model and image classification model, and use cross-validation to evaluate the model performance to obtain the multi-modal risk assessment model.

3. An apparatus for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance according to claim 2, characterized in that, The loss function of the multi-modal risk assessment model is: where N is the number of samples, C is the number of classes, and p i,c is the probability that the i-th sample predicted by the model belongs to class c, and y i,c is the true label of the i-th sample, the predicted value of the model for the i-th sample, and α and β are the weight ratios respectively.

4. An apparatus for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance according to claim 1, characterized in that, The ultrasonic thermogram is obtained from the images of the spinal anatomical structure and the epidural space displayed by the guiding probe, including: Generate an image using the reflection and propagation characteristics of ultrasonic waves in tissues; Display the signal intensity or temperature distribution of different regions through color changes; Convert the original image into a thermogram to highlight the epidural space and its surrounding structures; Form a thermogram guidance trajectory according to the thermogram trend and display it in a split screen for visualization.

5. An apparatus for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance according to claim 4, wherein The probe guidance module is also used for: Slowly insert the combined electrode assembly along the thermogram guidance trajectory direction into the skin, and gradually advance under the guidance of the thermogram guidance trajectory to ensure that the needle tip approaches the target position; During the operation, the operator holds the ultrasonic probe with one hand to guide the probe to display the images of the spinal anatomical structure and the epidural cavity, and holds the temporary electrode with the other hand to insert the needle along the ultrasonic-guided trajectory.

6. An apparatus for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance according to claim 1, characterized in that, The risk assessment module is further configured to: Conduct a comprehensive assessment of the patient to ensure their suitability for electrode implantation, including assessing the medical history, spinal structure, and related diseases.

7. An apparatus for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasonic guidance according to claim 1, characterized in that, The recording and monitoring are further configured to: The needle insertion range is bilateral on the posterior midline, at the T 11 / T 12, T 12 / L 1, and L 1 / L 2 intervertebral spaces. Leave 1 electrode at each vertebral interspace on each side, for a total of 6 needles. Connect the negative electrode to the positive electrode from the inside out, and set the parameters as follows: frequency 10H Z, current intensity 0 - 5m A, time 60min, pulse width 1m s; And make fine adjustments according to the patient's feedback.

8. A system for implanting an epidural temporary electrode for spinal cord stimulation under ultrasound guidance, which is applied to the device for implanting an epidural temporary electrode for spinal cord stimulation under ultrasound guidance as described in any one of claims 1 to 7, characterized in that, It further includes An ultrasonic electronic system, a puncture needle tube, and an ultrasonic transducer; The ultrasonic electronic system is connected to the ultrasonic transducer; The main body of the puncture needle tube consists of a needle core, a metal braided sleeve, and an outer plastic sleeve from the inside out. The head end of the needle tube body is a needle-shaped metal head, which is connected to the plastic sleeve and the metal braided sleeve; the tail end of the main body is a power transfer female head, which is connected to the metal sleeve and the plastic sleeve of the main body.

9. A system for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasound guidance according to claim 8, characterized in that, The plastic sleeve is a hard plastic sleeve.

10. A system for temporarily stimulating the spinal cord by implanting an epidural electrode under ultrasound guidance according to claim 9, characterized in that, The specific operation of the puncture needle tube is as follows Insert the needle core into the metal sleeve to form Assembly 1; Insert Assembly 1 into the hard plastic sleeve again to form Assembly 2; During use, align it with the specific position, hold the hard plastic sleeve, tap the tail end of the needle core, and the needle tip can penetrate the skin. After adjusting the depth, pull out the needle core; The plastic sleeve part of the electrode is made of a soft material and bends together with the metal braided sleeve. The tail end is connected to the treatment instrument adapter.

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