Surgical planning device and method, medical system, and storage medium

Abstract

The present application provides a surgical planning device, a surgical planning method, a medical system, and a computer-readable storage medium for implanting a medical device into a patient's head. The surgical planning device includes a memory and at least one processor, the memory storing a computer program, and the at least one processor being configured to implement the following steps when executing the computer program: acquiring medical imaging data of the patient's skull; performing a three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, the three-dimensional reconstruction result including a skull thickness distribution result; and acquiring an implantation point for the medical device on the patient's skull based on the skull thickness distribution result and a preset thickness screening condition. The present application utilizes the individual patient's skull thickness distribution to quickly and accurately select implantation points, thereby improving the accuracy and efficiency of treatment.

Description

Technical Field

[0001] The present application relates to the technical fields of surgical planning and deep brain stimulation, and in particular to surgical planning equipment, surgical planning methods, medical systems, and computer-readable storage media. Background Art

[0002] In some surgical procedures, medical devices need to be implanted in the patient's head. However, to reduce surgical risks, the implant location must be planned preoperatively, taking into account the impact of the device's size on scalp tension and post-suturing aesthetics.

[0003] The traditional method is to select a rough area for skull resection or bone trough grinding based on preoperative imaging data and the doctor's experience, and then implant the medical device. However, this selection method is time-consuming.

[0004] Based on this, the present application provides a surgical planning device, a surgical planning method, a medical system and a computer-readable storage medium to improve related technologies. Summary of the Invention

[0005] The purpose of this application is to provide a surgical planning device, a surgical planning method, a medical system and a computer-readable storage medium, which utilize the individual patient's skull thickness distribution to quickly and accurately select implantation points and improve the accuracy and efficiency of treatment.

[0006] The purpose of this application is achieved by the following technical solutions:

[0007] In a first aspect, the present application provides a surgical planning device for implanting a medical device into a patient's head, the surgical planning device comprising a memory and at least one processor, the memory storing a computer program, the at least one processor being configured to implement the following steps when executing the computer program:

[0008] Acquiring medical imaging data of the patient's skull;

[0009] Performing three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes a skull thickness distribution result;

[0010] The implantation point of the medical device on the patient's skull is obtained according to the skull thickness distribution result and a preset thickness screening condition.

[0011] In some possible implementations, the at least one processor is configured to determine the medical device in the following manner when executing the computer program:

[0012] According to the skull thickness distribution result, a model is selected from multiple models of candidate medical devices to determine one model of the candidate medical device as the medical device.

[0013] In some possible implementations, the skull thickness distribution result is in the form of a skull thickness distribution heat map or a skull two-dimensional contour map.

[0014] In some possible implementations, the three-dimensional reconstruction result further includes a three-dimensional skull model, the three-dimensional skull model having a relative inner skull surface and an outer skull surface, and the thickness screening condition is used to indicate a thickness range corresponding to the medical device;

[0015] The at least one processor is configured to, when executing the computer program, obtain the implantation point of the medical device on the skull of the patient in the following manner:

[0016] According to the skull thickness distribution result, detecting whether there is a point to be measured on the outer surface of the skull whose corresponding thickness is within the thickness range;

[0017] If so, one or more points to be measured on the outer surface of the skull with corresponding thickness within the thickness range are placed into a preselected point set;

[0018] One of the preselected points is determined from the set of preselected points as the implantation point of the medical device on the skull of the patient.

[0019] In some possible implementations, the at least one processor is configured to, when executing the computer program, determine one of the preselected points from the set of preselected points as the implantation point of the medical device on the patient's skull in the following manner:

[0020] Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other;

[0021] Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point;

[0022] According to the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull.

[0023] In some possible implementations, the at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner:

[0024] The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

[0025] In some possible implementations, the at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner:

[0026] The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0027] Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result;

[0028] According to the projection result, the degree of fit corresponding to the preselected point is obtained.

[0029] In some possible implementations, the projection result includes a projection point corresponding to each point on the upper surface of the device;

[0030] The at least one processor is configured to obtain the degree of fit corresponding to the preselected point in the following manner when executing the computer program:

[0031] Calculate the difference in curvature between each point and its corresponding projected point;

[0032] Calculate the sum of squares of the differences in curvature corresponding to all points on the surface of the device;

[0033] The degree of fit corresponding to the preselected point is obtained according to the sum of squares.

[0034] In some possible implementations, the projection result includes a projection image of the upper surface of the skull;

[0035] The at least one processor is configured to further implement the following steps when executing the computer program:

[0036] generating a first color mapping image corresponding to the surface of the device according to the curvature of each point on the surface of the device;

[0037] generating a second color mapping image corresponding to the outer surface of the skull according to the curvature of each point to be measured on the outer surface of the skull, wherein the second color mapping image and the first color mapping image adopt the same color mapping rule;

[0038] The at least one processor is configured to obtain the degree of fit corresponding to the preselected point in the following manner when executing the computer program:

[0039] intercepting a third color mapping image corresponding to the projection image from the second color mapping image;

[0040] calculating a similarity between the first color mapping image and the third color mapping image;

[0041] According to the similarity, the degree of fit corresponding to the preselected point is obtained.

[0042] In some possible implementations, the at least one processor is configured to further implement the following steps when executing the computer program:

[0043] The planned implantation path of the electrode wire is obtained by planning.

[0044] In a second aspect, the present application provides a surgical planning method for implanting a medical device into a patient's head, the method comprising:

[0045] Acquiring medical imaging data of the patient's skull;

[0046] Performing three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes a skull thickness distribution result;

[0047] The implantation point of the medical device on the patient's skull is obtained according to the skull thickness distribution result and a preset thickness screening condition.

[0048] In some possible implementations, the process of determining the medical device includes:

[0049] According to the skull thickness distribution result, a model is selected from multiple models of candidate medical devices to determine one model of the candidate medical device as the medical device.

[0050] In some possible implementations, the skull thickness distribution result is in the form of a skull thickness distribution heat map or a skull two-dimensional contour map.

[0051] In some possible implementations, the three-dimensional reconstruction result further includes a three-dimensional skull model, the three-dimensional skull model having a relative inner skull surface and an outer skull surface, and the thickness screening condition is used to indicate a thickness range corresponding to the medical device;

[0052] The step of obtaining an implantation point of the medical device on the patient's skull based on the skull thickness distribution result and a preset thickness screening condition includes:

[0053] According to the skull thickness distribution result, detecting whether there is a point to be measured on the outer surface of the skull whose corresponding thickness is within the thickness range;

[0054] If so, one or more points to be measured on the outer surface of the skull with corresponding thickness within the thickness range are placed into a preselected point set;

[0055] One of the preselected points is determined from the set of preselected points as the implantation point of the medical device on the skull of the patient.

[0056] In some possible implementations, determining one of the preselected points from the set of preselected points as the implantation point of the medical device on the skull of the patient includes:

[0057] Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other;

[0058] Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point;

[0059] According to the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull.

[0060] In some possible implementations, obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point includes:

[0061] The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

[0062] In some possible implementations, obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point includes:

[0063] The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0064] Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result;

[0065] According to the projection result, the degree of fit corresponding to the preselected point is obtained.

[0066] In some possible implementations, the projection result includes a projection point corresponding to each point on the upper surface of the device;

[0067] The obtaining, according to the projection result, the degree of fit corresponding to the preselected point includes:

[0068] Calculate the difference in curvature between each point and its corresponding projected point;

[0069] Calculate the sum of squares of the differences in curvature corresponding to all points on the upper surface of the device;

[0070] The degree of fit corresponding to the preselected point is obtained according to the sum of squares.

[0071] In some possible implementations, the projection result includes a projection image of the upper surface of the skull;

[0072] The method further comprises:

[0073] generating a first color mapping image corresponding to the surface of the device according to the curvature of each point on the surface of the device;

[0074] generating a second color mapping image corresponding to the outer surface of the skull according to the curvature of each point to be measured on the outer surface of the skull, wherein the second color mapping image and the first color mapping image adopt the same color mapping rule;

[0075] The obtaining, according to the projection result, the degree of fit corresponding to the preselected point includes:

[0076] intercepting a third color mapping image corresponding to the projection image from the second color mapping image;

[0077] calculating a similarity between the first color mapping image and the third color mapping image;

[0078] According to the similarity, the degree of fit corresponding to the preselected point is obtained.

[0079] In some possible implementations, the method further includes:

[0080] The planned implantation path of the electrode wire is obtained by planning.

[0081] In a third aspect, the present application provides a medical system, comprising:

[0082] A surgical planning device for planning the implantation path of the electrode wire and obtaining the implantation point of the medical device on the patient's skull using the above method;

[0083] a surgical robot, configured to implant the electrode wire into the patient's head according to the planned implantation path;

[0084] The surgical navigation device is used to perform path navigation during the implantation process of the electrode wire so that the actual implantation path of the electrode wire matches the planned implantation path.

[0085] In some possible implementations, the medical system further includes:

[0086] an electrophysiological acquisition device, used to acquire electrophysiological data of the patient during the implantation process;

[0087] The surgical planning device is further configured to determine whether the planned implantation path needs to be updated based on the electrophysiological data of the patient; if an update is required, the planned implantation path of the patient is updated.

[0088] In some possible implementations, the medical system further includes:

[0089] A medical device is implanted in the patient's head, collects the patient's electrophysiological data and sends it to the electrophysiological acquisition device, and delivers electrical stimulation to the patient's brain tissue.

[0090] In some possible implementations, the medical device is a pulse generator.

[0091] In a fourth aspect, the present application provides a computer-readable storage medium storing a computer program, which, when executed by at least one processor, implements the functions of any of the above-mentioned surgical planning devices or the steps of any of the above-mentioned surgical planning methods.

[0092] In a fifth aspect, the present application provides a computer program product, which includes a computer program, and when the computer program is executed by at least one processor, it implements the functions of any of the above-mentioned surgical planning devices or implements the steps of any of the above-mentioned surgical planning methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0093] The present application is further described below with reference to the accompanying drawings and specific implementation methods.

[0094] Figure 1 This is a flowchart of a surgical planning method provided in an embodiment of the present application.

[0095] Figure 2 This is a structural block diagram of a surgical planning device provided in an embodiment of the present application.

[0096] Figure 3 This is a structural block diagram of a medical system provided in an embodiment of the present application.

[0097] Figure 4This is a structural block diagram of a deep brain stimulation device provided in an embodiment of the present application.

[0098] Figure 5 This is a structural block diagram of another deep brain stimulation device provided in an embodiment of the present application.

[0099] Figure 6 It is a structural diagram of a computer program product provided in an embodiment of the present application. DETAILED DESCRIPTION

[0100] The technical solutions in this application will be described below in conjunction with the accompanying drawings and specific implementation methods of this application. It should be noted that, under the premise of no conflict, the various implementation methods or technical features described below can be arbitrarily combined to form a new implementation method.

[0101] In the examples of this application, words such as "exemplary" or "for example" are used to indicate examples, illustrations, or descriptions. Any embodiment or design described as "exemplary" or "for example" in the examples of this application should not be interpreted as being preferred or advantageous over other embodiments or designs. Rather, the use of words such as "exemplary" or "for example" is intended to present the relevant concepts in a concrete manner.

[0102] The first, second, etc. descriptions appearing in the embodiments of the present application are only used for illustration and distinction of the description objects. There is no order, nor does it indicate a special limitation on the quantity in the embodiments of the present application, and cannot constitute any limitation on the embodiments of the present application.

[0103] The following is a brief description of the technical field and related terms of the embodiments of the present application.

[0104] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead adapter systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0105] An implantable neural electrical stimulation system consists of a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device located outside the patient's body. In other words, a stimulator is a medical device, or rather, a medical device includes a stimulator. Related neuromodulation technologies primarily involve implanting electrodes (e.g., in the form of electrode wires) at specific locations (i.e., target sites) within a living organism through stereotactic surgery. These electrodes then send electrical pulses to the target sites, modulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0106] As an example, DBS includes an implantable pulse generator (IPG), an extension lead, and an electrode lead. The IPG is connected to the electrode lead via the extension lead. The IPG is implanted in the patient's body, for example, in the chest or other internal body parts.

[0107] As another example, DBS includes an IPG and an electrode lead, with the IPG directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, by making a groove in the patient's skull and then installing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may partially protrude from the outer surface of the skull.

[0108] The IPG responds to programmed instructions from a programmable device, relying on sealed batteries and circuits to provide controlled electrical stimulation therapy (or electrical stimulation energy) to tissues within the body. Through electrodes and wires, the IPG delivers one or more specific, controllable electrical stimulation pathways to specific areas of tissue within the body.

[0109] In some embodiments, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, transmitting the electrical stimulation generated by the IPG to the electrode lead.

[0110] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal having a variety of waveform shapes, frequencies, and amplitudes. Thus, electrical stimulation in the form of a non-pulsed signal can be a continuous signal, which can have a sinusoidal waveform or other continuous waveform.

[0111] After receiving the electrical stimulation transmitted by the IPG or the extension wire, the electrode wire delivers the electrical stimulation to a specific area of ​​the tissue in the body through a plurality of electrode contacts. The stimulator is provided with, for example, one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wire. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire. The electrode contacts can include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts can be in the shape of sheets, rings, dots, etc., for example.

[0112] In some embodiments, the stimulated in vivo tissue may be the patient's brain tissue, and the stimulated site may be a specific site in the brain tissue. Depending on the patient's disease type, the stimulated site generally varies, as does the number of stimulation contacts (single source or multiple sources), the use of one or more specific electrical stimulation channels (single channel or multiple channels), and the stimulation parameters (values).

[0113] The embodiments of the present application do not limit the types of diseases that can be treated, and can be diseases that are suitable for deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic disorders (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, minor depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and injuries.

[0114] In an embodiment of the present application, when a programmable connection is established between a programmable device and a stimulator, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of a pulse generator, different stimulation parameters correspond to different electrical stimulations), or the stimulator can be used to sense the patient's electrophysiological activities to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue to adjust the stimulation parameters of the stimulator, thereby realizing closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0115] The stimulation parameters may include at least one of the following: the electrode contact identification used to deliver electrical stimulation (for example, electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation pulse signals within a unit time of 1s, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to a discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor (the range that the doctor can adjust) and upper and lower limits controlled by the patient (the range that the patient can adjust independently).

[0116] In some embodiments, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0117] Programmable devices may include doctor-controlled devices (i.e., programmable devices used by doctors) and / or patient-controlled devices (i.e., programmable devices used by patients). Examples of doctor-controlled devices include tablet computers, laptop computers, desktop computers, mobile phones, and other intelligent terminal devices equipped with programmable software. Examples of patient-controlled devices include tablet computers, laptop computers, desktop computers, mobile phones, and other intelligent terminal devices equipped with programmable software. Patient-controlled devices may also include other electronic devices with programmable functions (e.g., chargers with programmable functions, electrophysiological data acquisition devices, etc.).

[0118] The embodiments of the present application do not restrict the data interaction between the doctor-controlled device and the stimulator. When the doctor performs remote programming, the doctor-controlled device can exchange data with the stimulator through the server and the patient-controlled device. When the doctor performs offline programming with the patient face-to-face, the doctor-controlled device can exchange data with the stimulator through the patient-controlled device, or directly with the stimulator.

[0119] In some embodiments, the patient programmable device may include a host (communicating with a server) and a slave (communicating with a stimulator), and the host and slave are communicatively connected. The doctor programmable device may exchange data with the server via a 3G / 4G / 5G network, the server may exchange data with the host via a 3G / 4G / 5G network, the host may exchange data with the slave via a Bluetooth protocol / WIFI protocol / USB protocol, the slave may exchange data with the stimulator via a 401MHz-406MHz operating frequency band / 2.4GHz-2.48GHz operating frequency band, and the doctor programmable device may directly exchange data with the stimulator via a 401MHz-406MHz operating frequency band / 2.4GHz-2.48GHz operating frequency band.

[0120] Patent CN112100631A discloses a method and terminal for determining whether a PPTX document is encrypted. However, when the document is not opened using third-party software such as PowerPoint or WPS, it is impossible to determine whether it is encrypted, which affects subsequent operations on the document. Data files containing electrophysiological data (such as EEG data) collected by electrophysiological acquisition equipment are typically text files represented in ASCII characters. Computers cannot distinguish between encrypted and unencrypted files, which affects subsequent data processing.

[0121] The relevant patents target PPTX documents and are not applicable to EEG data (e.g., in the form of text files, binary data, hexadecimal data, etc.). Furthermore, the relevant patents primarily concern the determination of encryption and non-encryption, and do not address the compatibility of encrypted and non-encrypted data.

[0122] Currently, the data used by electrophysiological acquisition software during surgical planning may be original unencrypted data, encrypted data, or decrypted unencrypted data (of encrypted data). However, the relevant technology can only play one type of data and cannot be compatible with both encrypted and unencrypted data.

[0123] Based on this, this application provides surgical planning equipment, surgical planning methods, medical systems, computer-readable storage media, and computer program products to improve related technologies. This application also provides a method for parsing and compatibly processing encrypted / unencrypted data, and can identify illegal files. This method can adapt to the characteristics of electrophysiological data such as EEG data and provide the ability to parse and process encrypted / unencrypted data to meet the needs of surgical planning.

[0124] The solutions provided in the embodiments of this application involve technologies such as data processing and deep brain stimulation, which are specifically illustrated by the following embodiments. It should be noted that the order of description of the following embodiments does not limit the preferred order of the embodiments.

[0125] (Surgical Planning Method)

[0126] See also Figure 1 , Figure 1 This is a flowchart of a surgical planning method provided in an embodiment of the present application.

[0127] An embodiment of the present application provides a surgical planning method for implanting a medical device into a patient's head, the method comprising:

[0128] Step S101: Acquire medical imaging data of the patient's skull;

[0129] Step S102: performing three-dimensional reconstruction of the patient's skull according to the medical imaging data to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes a skull thickness distribution result;

[0130] Step S103: obtaining the implantation point of the medical device on the patient's skull according to the skull thickness distribution result and a preset thickness screening condition.

[0131] Medical devices refer to instruments, equipment, tools or systems used to diagnose, treat, monitor or help prevent disease. In electrical stimulation therapy, medical devices are, for example, stimulation generators used to deliver electrical stimulation, such as pulse generators.

[0132] The skull is the skeletal structure of the human head, consisting of multiple bones, including the parietal, base, and facial bones. The skull protects the brain and other important nervous systems.

[0133] Medical imaging data is image data about the internal structure or function of the human body obtained through medical imaging technology. Medical imaging data can come from a variety of imaging technologies, such as X-rays, CT scans, and magnetic resonance imaging (MRI).

[0134] 3D reconstruction is the process of converting medical imaging data into a 3D model. By analyzing the pixel values ​​and geometric information in medical imaging data, the 3D shape and position of human organs or structures can be reconstructed.

[0135] The skull thickness distribution result is a 3D reconstruction of the skull, which shows the thickness of different skull regions and is used to guide the selection of implant locations for medical devices.

[0136] Preset thickness screening conditions are pre-defined based on skull thickness distribution results to identify suitable skull regions for medical device implantation. These conditions can be determined based on treatment needs and safety considerations, such as requiring a certain skull thickness range to ensure implant stability.

[0137] During medical device implantation, the implant site refers to the specific location of the medical device on the patient's skull. The choice of implant site is typically based on factors such as the skull's anatomy, the specifics of the condition, and the desired treatment.

[0138] This surgical planning method aims to implant a medical device in the patient's head. First, detailed imaging data of the patient's skull is acquired using medical imaging techniques (such as CT scans or MRIs). Next, the acquired imaging data is used to perform a three-dimensional reconstruction of the patient's skull through computer processing and image reconstruction algorithms. For example, a three-dimensional model of the skull, encompassing its shape and structure, is generated. Based on the 3D reconstruction, the skull data is analyzed to calculate the thickness distribution of various skull regions, providing spatial information on skull thickness. Based on this skull thickness distribution and pre-set thickness screening criteria, the implantation point of the medical device on the patient's skull is determined. By selecting the implantation point in a specific skull region, the safe and effective implantation of the medical device can be ensured.

[0139] The advantage of doing this is that, by utilizing the patient's individual skull morphology and structure information, an individualized surgical plan can be developed for each patient to ensure the accuracy and feasibility of the implantation point; by analyzing the distribution of skull thickness, excessive implantation of the implant device (for example, contact with the outer surface of the dura mater) or mismatch with the skull structure can be avoided, thereby reducing surgical risks and complications; rapid and accurate selection of implantation points can ensure good contact between the medical device and the target area, optimize the effect of electrical stimulation treatment, and improve the accuracy and efficiency of treatment; by planning the surgery in advance, the operating time and trauma during the operation can be reduced, and the patient's surgical experience and recovery speed can be improved.

[0140] In some embodiments, the medical device determination process includes:

[0141] According to the skull thickness distribution result, a model is selected from multiple models of candidate medical devices to determine one model of the candidate medical device as the medical device.

[0142] Models refer to different specifications, configurations, or versions of medical devices. Different models of medical devices may have different features, such as functions, sizes, and shapes. For example, the medical device is a pulse generator, which comes in both rechargeable and non-rechargeable models.

[0143] Alternative medical devices refer to multiple medical device models available for selection during the selection process, with different characteristics and adaptability, which can be selected according to the patient's needs and conditions.

[0144] Model selection involves choosing the appropriate device model from among a pool of potential medical devices. When selecting a model based on skull thickness distribution results, the candidate device can be evaluated based on factors such as its compatibility with skull thickness, adaptability, and therapeutic efficacy. For example, a device with a similar skull thickness might be selected.

[0145] For example, in electrical stimulation therapy, there are multiple candidate medical devices, A, B, C, D, and E. Based on the patient's skull thickness distribution results, the characteristics and adaptability of these candidate medical devices are analyzed, and the most suitable candidate medical device is selected as the final model (i.e., the medical device). For example, based on the skull thickness distribution results, the shape and size of candidate medical device C are found to be more suitable for the patient's skull structure, so model C is selected as the final medical device.

[0146] By analyzing and calculating the thickness distribution of the patient's skull, we can obtain information about the thickness of different skull regions. Based on this skull thickness distribution, we select a model from among multiple candidate medical devices. These devices may have different shapes, sizes, adaptability, and functional characteristics. Based on the skull thickness distribution results and a comprehensive consideration of the characteristics and adaptability of the candidate medical devices, we select one model as the final medical device.

[0147] The benefit of this is that by selecting from multiple models of alternative medical devices, it ensures that all patients can be matched with a device model that suits them under existing technology. Even under limited conditions (for example, some patients' skulls are too thick or too small), as long as there are enough and extensive alternative models, patients can still obtain medical devices that suit them. Selecting appropriate medical devices based on the skull thickness distribution results can achieve more personalized treatment. The skull thickness distribution of different patients may vary. The selection process can ensure that the selected medical device matches the patient's skull structure, thereby meeting the patient's individual treatment needs. Ensuring that patients can be matched with a device model that suits them improves the success rate of treatment. The appropriate model of medical device can better adapt to the patient's skull structure and treatment needs, thereby increasing the treatment effect and the realization of expected clinical results. Selecting the appropriate medical device model can reduce problems during the implantation process, such as over-implantation or mismatch with the skull, thereby reducing the risk of surgical complications. Ensuring that patients can be matched with a medical device model that suits them can enhance patient satisfaction. Personalized treatment options can improve the patient's treatment experience, making them feel more satisfied and comfortable.

[0148] In some embodiments, the skull thickness distribution result is in the form of a skull thickness distribution heat map or a skull two-dimensional contour map.

[0149] A skull thickness distribution heatmap is a visualization method that presents skull thickness distribution results in the form of a heatmap. A heatmap uses different colors to represent areas of varying thickness, similar to a color spectrum. For example, thinner areas might be represented by cool colors (such as blue), while thicker areas might be represented by warm colors (such as red).

[0150] A 2D skull contour map visualizes the distribution of skull thickness using contour lines. A contour map uses contour lines (or isovalue lines) to connect points of equal thickness, forming a contour line. Each contour line represents a specific thickness of the skull, and the distribution and shape of the contour lines allow you to observe variations in skull thickness.

[0151] For example, a skull thickness distribution heat map can be presented as a colorful image, with different colored areas representing areas of varying skull thickness. Thicker skull areas might appear red or orange, while thinner areas might appear blue or green. Such a heat map can help doctors visually identify the location and extent of variations in skull thickness.

[0152] On the other hand, a 2D skull contour map can display skull thickness distribution results in the form of contour lines. Different contour lines represent areas of skull thickness, and the shape and spacing of the contour lines reflect the thickness variation. Such contour maps can help doctors more clearly understand the spatial distribution and characteristics of skull thickness.

[0153] Therefore, the skull thickness distribution results are presented in a visual form, such as a skull thickness distribution heat map and a skull two-dimensional contour map.

[0154] The advantage of this approach is that, by using skull thickness distribution heat maps or two-dimensional skull contour maps, the spatial variation of skull thickness distribution can be intuitively demonstrated. This visualization allows doctors and other medical professionals to more intuitively understand the thickness of different areas of the skull. Skull thickness distribution heat maps or two-dimensional skull contour maps can serve as a reference for selecting implantation sites during electrical stimulation therapy. Based on these visualization results, doctors can select appropriate implantation sites to ensure good contact between the medical device and the skull and achieve the desired effect. Visualizing skull thickness distribution results can achieve personalized treatment plans. Skull thickness distribution may vary from patient to patient. Based on the visualization results, a specific treatment plan can be developed for each patient to ensure accurate implantation points and personalized treatment. Skull thickness distribution heat maps or two-dimensional skull contour maps can be used to assess risks during implantation. By observing the skull thickness distribution in the image, overimplantation or mismatch with the skull structure can be avoided, reducing surgical risks and complications. These visualization methods can help doctors better understand the structure and thickness variations of the skull, thereby optimizing the positioning and stimulation parameter settings for electrical stimulation therapy. By accurately understanding the skull thickness distribution, the delivery efficiency of electrical stimulation can be improved and the treatment effect can be optimized.

[0155] In some embodiments, the three-dimensional reconstruction result further includes a three-dimensional skull model, wherein the three-dimensional skull model has a relative inner skull surface and an outer skull surface, and the thickness screening condition is used to indicate a range of a sum of squared thickness differences corresponding to the medical device;

[0156] The step of obtaining an implantation point of the medical device on the patient's skull based on the skull thickness distribution result and a preset thickness screening condition includes:

[0157] According to the skull thickness distribution result, obtaining the sum of squares of thickness differences corresponding to each measured point on the outer surface of the skull;

[0158] Detecting whether there is a point on the outer surface of the skull whose corresponding sum of squared thickness differences is within the range of the sum of squared thickness differences;

[0159] If so, one or more test points on the outer surface of the skull whose corresponding sum of squared thickness differences is within the range of the sum of squared thickness differences are taken as preselected points and put into the preselected point set;

[0160] Determining one of the preselected points from the set of preselected points as an implantation point of the medical device on the skull of the patient;

[0161] The process of obtaining the sum of squares of thickness differences corresponding to each point to be measured on the outer surface of the skull includes:

[0162] The following processing is performed for each point to be measured on the outer surface of the skull:

[0163] The three-dimensional model of the device is set based on the point to be measured, so that the center point of the upper surface of the device coincides with the point to be measured, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the point to be measured, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0164] Projecting the upper surface of the device onto the upper surface of the skull to obtain a projection point corresponding to each point on the upper surface of the device;

[0165] Obtaining the device thickness at each point on the upper surface of the device and the skull thickness at its corresponding projection point;

[0166] Calculate the thickness difference between the device thickness at each point on the upper surface of the device and the skull thickness at its corresponding projection point as the thickness difference corresponding to each point on the upper surface of the device;

[0167] The sum of squares of thickness differences corresponding to all points on the upper surface of the device is calculated as the sum of squares of thickness differences corresponding to the points to be measured.

[0168] In the above embodiment, the skull thickness distribution results and preset thickness screening conditions are used to determine the implantation point of the medical device on the patient's skull. This process includes the following steps: obtaining the sum of the squared thickness differences of each test point on the skull's outer surface; detecting whether any test points on the skull's outer surface have a sum of the squared thickness differences within a preset range; placing the test points that meet the conditions as preselected points into a set of preselected points; and determining a preselected point from the set of preselected points as the implantation point for the medical device.

[0169] Among them, the process of obtaining the sum of the squares of the thickness differences corresponding to each point to be measured on the outer surface of the skull includes the following steps: setting a three-dimensional model of the device according to the point to be measured, ensuring that the center point of the upper surface of the device coincides with the point to be measured, the height direction of the device is parallel to the normal of the outer surface of the skull at the point to be measured, and the length direction of the device is parallel or perpendicular to the patient's midsagittal plane; projecting the upper surface of the device onto the outer surface of the skull to obtain the projection point corresponding to each point on the device; obtaining the device thickness of each point on the device and the skull thickness of the corresponding projection point; calculating the thickness difference between the device thickness of each point on the device and the skull thickness of the corresponding projection point as the thickness difference of the point; calculating the sum of the squares of the thickness differences of all points on the device as the sum of the squares of the thickness differences of the points to be measured.

[0170] The advantage of this is that through analysis based on skull thickness distribution, the pre-selected points of the medical device can be accurately determined, and then the implantation points can be accurately determined, thereby improving the positioning accuracy of the treatment; according to the patient's skull morphology and thickness distribution, by screening the points to be tested, the pre-selected points and implantation points suitable for the patient can be screened out to achieve a personalized treatment plan; by calculating the sum of the squares of the thickness differences, the degree of thickness matching of the device at the points to be tested can be evaluated, thereby achieving a more accurate thickness screening process.

[0171] In some embodiments, the three-dimensional reconstruction result further includes a three-dimensional skull model, wherein the three-dimensional skull model has a relative inner skull surface and an outer skull surface, and the thickness screening condition is used to indicate a thickness range corresponding to the medical device;

[0172] The step of obtaining an implantation point of the medical device on the patient's skull based on the skull thickness distribution result and a preset thickness screening condition includes:

[0173] According to the skull thickness distribution result, detecting whether there is a point to be measured on the outer surface of the skull whose corresponding thickness is within the thickness range;

[0174] If so, one or more points to be measured on the outer surface of the skull with corresponding thickness within the thickness range are placed into a preselected point set;

[0175] One of the preselected points is determined from the set of preselected points as the implantation point of the medical device on the skull of the patient.

[0176] In this embodiment, a three-dimensional model of the patient's skull (i.e., a three-dimensional skull model) is generated by processing and calculating medical imaging data. A three-dimensional skull model represents the patient's skull in three dimensions, including the skull's internal surface (i.e., the inner surface of the skull) and external surface (i.e., the outer surface of the skull). It may also include reconstructions of other structures and can be used for positioning, measurement, analysis, and treatment planning. The inner surface of the skull refers to the surface in contact with brain tissue, while the outer surface refers to the surface in contact with the scalp.

[0177] The preselected point set is a set of potential implantation points (i.e., preselected points) formed by detecting test points on the outer surface of the skull within an applicable thickness range based on the skull thickness distribution results and thickness screening criteria. This embodiment of the present application does not limit the number of preselected points in the preselected point set; for example, the number may be 1, 10, 100, 1,000, 10,000, etc.

[0178] Assume that, in an electrical stimulation treatment plan, patient A needs to have a pulse generator implanted that is suitable for areas with a skull thickness range of 5 mm to 6 mm. Therefore, the thickness screening condition is used to indicate a thickness range of 5 mm to 6 mm. This means that in the skull thickness distribution results, only test points within this range will be considered as possible implantation sites. Assuming that in the skull thickness distribution results for patient A, the thickness of a test point on the outer surface of the skull is 5.5 mm, then this test point meets the thickness screening condition. Therefore, this test point can be selected as a preselected point and included in the preselected point set as one of the possible implantation sites.

[0179] Thus, by processing and analyzing the patient's medical imaging data, a three-dimensional reconstruction result of the skull is obtained, including a three-dimensional skull model. Based on the skull thickness distribution results and implantation requirements (for example, the shape parameters of the therapeutic device need to be taken into account), thickness screening conditions are set to indicate the applicable thickness range of the medical device. Based on the skull thickness distribution results and the preset thickness screening conditions, the implantation point is determined. On the outer surface of the skull, it is detected whether there are test points whose thickness is within the specified thickness range, and the test points that meet the conditions are pre-selected points and placed in the pre-selected point set. Finally, a pre-selected point is determined from the pre-selected point set as the implantation point of the medical device on the patient's skull.

[0180] The advantage of this is that through the three-dimensional skull model and thickness screening conditions, an individualized treatment plan can be developed for each patient. Based on the patient's skull structure and thickness characteristics, the appropriate implantation point is selected to ensure good contact between the medical device and the skull and achieve the desired treatment effect; the optimal medical device implantation point is determined based on the skull thickness distribution results and the preset thickness screening conditions; determining the implantation point based on the skull thickness distribution results and thickness screening conditions can reduce surgical risks and reduce problems during the implantation process; ensuring that the medical device is implanted at the appropriate point can improve the transmission efficiency and treatment effect of electrical stimulation therapy, ensure that the target area of ​​electrical stimulation is accurately and effectively stimulated, and optimize the treatment results; individualized treatment and optimal implantation point selection can improve patient satisfaction. By considering the patient's skull characteristics and determining the appropriate implantation point, more accurate, safe and effective treatment can be provided, enhancing the patient's confidence and satisfaction with the treatment.

[0181] In some embodiments, determining one of the preselected points from the set of preselected points as the implantation point of the medical device on the patient's skull includes:

[0182] Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other;

[0183] Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point;

[0184] According to the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull.

[0185] A 3D device model is a 3D virtual model of a medical device generated on a computing device. This model can represent the shape, size, and features of the medical device and can be used to assess the fit of the medical device against the patient's skull. This application does not limit the shape of the medical device to any of the following: a rectangular parallelepiped, a cylinder, a frustum, a sphere, or a shape similar to a rectangular parallelepiped (e.g., with curved upper and lower surfaces).

[0186] The upper surface of a medical device refers to the surface of the device that is closest to the patient's scalp, while the lower surface of the device refers to the surface of the device that is in contact with the patient's skull.

[0187] Fit is a measure of the degree of fit between the upper surface of the device and the outer surface of the skull. Fit can be assessed by measuring factors such as contact area, distance, and shape matching between the upper surface of the device and the outer surface of the skull. Fit can be expressed as a positive number, a ten-point scale, a hundredth scale, or a percentage, and this application is not limited to this.

[0188] For example, assuming the preselected point set includes multiple preselected points, the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point is obtained. Based on the degree of fit, the preselected point on the outer surface of the skull is evaluated to best fit the upper surface of the device. This preselected point is then selected as the final implantation point, which can be highlighted on the surgical planning device, for example.

[0189] In addition to directly selecting the preselected point with the highest degree of fit as the implantation point, in other embodiments, the surgical planning device can also display a three-dimensional skull model, a three-dimensional device model, and the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point. The fit of all preselected points is provided to the doctor, who comprehensively considers various influencing factors and manually selects a preselected point as the final implantation point. The implantation point selected by the doctor in this case is not necessarily the preselected point with the highest degree of fit, and this application does not limit this.

[0190] Therefore, first, a 3D model of the medical device is obtained for fit assessment in subsequent steps. For each point in the preselected point set, its fit with the upper surface of the device and the outer surface of the skull is calculated. Based on the fit between the upper surface of the device and the outer surface of the skull at the corresponding preselected point, the preselected point with the highest fit is selected as the final implant site. The preselected point with the highest fit indicates the best fit between the device and the patient's skull, potentially providing a better treatment effect.

[0191] The advantage of doing this is that by obtaining a three-dimensional model of the device, a set of pre-selected points, and a fit assessment, an individualized implant position planning plan can be developed for each patient. Taking into account the patient's skull morphology and device characteristics, the most suitable implant point can be selected, thereby reducing surgical risks and the occurrence of complications; by performing a fit assessment and selecting the pre-selected point with the highest fit as the implant point, the optimal fit between the medical device and the skull can be ensured; compared with traditional methods, the use of a set of pre-selected points and a fit assessment method can quickly determine the optimal implant point, reduce the scope of skull resection or bone grinding during surgery, and reduce surgical time and trauma; individualized implant position planning helps to improve the distribution of scalp tension when the implant is large, thereby improving postoperative aesthetic effects and wound healing.

[0192] There are many benefits to selecting the pre-selected point with the highest degree of fit as the implantation site. Through fit assessment, selecting the implantation point with the highest degree of fit can make the medical device fit better with the outer surface of the patient's skull, reduce possible bulges or protrusions, make the implantation site smoother and more natural, help the postoperative appearance be more in line with the normal head shape, and improve the patient's aesthetic experience; selecting the implantation point with the highest degree of fit can better hide the medical device and reduce the visible traces of the implantation site. Patients can more easily cover and hide the implantation site in daily life, reduce external attention and distress, and enhance personal privacy and self-confidence; implantation points with high fit can reduce friction and impact between the implanted device and surrounding tissues, helping to reduce tension and pressure on the wound. , which is beneficial to skin repair and tissue regeneration during wound healing, reduces scar formation, and improves the aesthetics of wounds; by selecting the implantation point with the highest fit, it can reduce friction and displacement between the implanted device and surrounding tissues, reduce the impact of implant stimulation and pressure on the skin and tissues, reduce the risk of postoperative infection, inflammation and other complications, and help promote faster and healthier postoperative recovery, reduce adverse reactions and treatment delays; the increased fit between the medical device and the patient's skull enables the skull to more firmly fix and support the medical device, helps prevent the medical device from being affected by lateral external forces, reduces the movement and displacement of the device, and provides a more stable implantation effect.

[0193] In some embodiments, obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point includes:

[0194] The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

[0195] The center point refers to the geometric center point of the upper surface of the device, which is located at the geometric center of the upper surface of the device.

[0196] Curvature is a measure of curvature at a specific point or area, used to describe the degree of curvature of a surface. For example, it can be expressed as the radius of curvature. A smaller radius of curvature indicates a greater curvature and a steeper curvature.

[0197] For example, the degree of fit is determined based on the curvature of the device's upper surface at its center and the curvature of the skull's outer surface at a preselected point. For example, the radius of curvature of the device's upper surface at its center is 2.0 mm, while the radius of curvature of the skull's outer surface at a preselected point is 1.9 mm. Based on these values, a fit value can be calculated, such as 1.9 / 2.0 = 0.95.

[0198] Therefore, first, the curvature of the upper surface of the device and the outer surface of the skull is calculated. By measuring the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at a preselected point, two curvature values ​​are obtained. Based on the obtained curvature values, the degree of fit is determined. By comparing the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at a preselected point, the degree of fit between the upper surface of the device and the outer surface of the skull can be evaluated. The higher the degree of fit, the better the device fits the skull. Next, each preselected point is evaluated based on the degree of fit between its corresponding upper surface of the device and the outer surface of the skull, and the preselected point with the highest degree of fit is selected as the final implantation point of the medical device on the patient's skull. This selection can ensure the optimal fit between the device and the skull, improve the treatment effect and reduce discomfort after implantation.

[0199] The degree of fit is determined by comparing the curvature of the upper surface of the device and the outer surface of the skull, which has the following advantages: small amount of calculation, simple and fast calculation. By comparing the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at a preselected point, the difference or proportional relationship between the curvatures can be directly obtained. This calculation method is relatively simple and does not require complex numerical calculations or iterative processes, reducing the complexity and time of the calculation. Due to the small amount of calculation and simple calculation, the fit of the preselected points can be quickly evaluated. In actual operation, the surgical planning equipment can quickly calculate and compare the fit of the preselected points to determine the optimal implantation point, saving surgical planning time and improving surgical efficiency. Compared with complex numerical calculation methods, the simple comparison between curvatures can reduce the demand for computing resources, does not require a large amount of computing power or high-performance computing equipment, and can be performed in a relatively simple computing environment. Due to the small amount of calculation and simple calculation, this method is suitable for real-time operation and quick decision-making scenarios.

[0200] In some embodiments, obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point includes:

[0201] The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0202] Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result;

[0203] According to the projection result, the degree of fit corresponding to the preselected point is obtained.

[0204] A normal is an imaginary line that is always perpendicular to a plane. The normal of a point on a surface is the line (i.e., a vector) that passes through that point and is perpendicular to the tangent plane at that point.

[0205] The midsagittal plane, also known as the midline sagittal or midsagittal plane, is a crucial reference plane in human anatomy. It is perpendicular to the coronal and transverse planes and divides the human body into two symmetrical halves. Specifically, the midsagittal plane runs through the midline of the head, from front to back, dividing the body into two symmetrical halves. In this plane, the left and right structures are mirror images of each other.

[0206] Projection refers to mapping the shape or features of an object onto another surface or plane. In this embodiment, projection refers to the process of projecting the upper surface of the device onto the outer surface of the skull.

[0207] For example, suppose the preselected point is a specific point on the outer surface of the skull, located at the top of the temporal bone. Assume that the coordinates of this preselected point in the anatomical coordinate system are (x, y, z) = (50, 60, 70). This anatomical coordinate system, for example, has the tip of the nose as the origin, horizontal lines parallel to the ground, vertical lines perpendicular to the ground, and different coordinate axes corresponding to the left-right, front-back, and top-bottom directions. The x coordinate represents the left-right direction, the y coordinate represents the front-back direction, and the z coordinate represents the top-bottom direction.

[0208] Therefore, first, according to the preselected point, the three-dimensional model of the device is set so that the center point of the upper surface of the device coincides with the preselected point. At the same time, the height direction of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the device is parallel or perpendicular to the patient's midsagittal plane. This ensures that the device is accurately aligned with the upper surface of the skull. Secondly, the upper surface of the device is projected onto the outer surface of the skull to obtain a projection result. This projection process is similar to mapping the shape of the device onto the surface of the skull so that the fit of the device can be observed on a two-dimensional plane. Based on the projection results, the degree of fit corresponding to the preselected point is calculated. For example, the curvature of the upper surface of the device at the preselected point can be compared with the curvature of the outer surface of the skull at that point, or the angle between the device surface and the skull surface at that point can be compared. Through this comparison, the degree of fit of the device to the skull at the preselected point can be evaluated.

[0209] The advantage of doing this is that, by setting up a three-dimensional model of the device, the position of the device on the patient's skull is ensured to be highly consistent with the pre-selected point, making the positioning of the implantation point more precise, which helps to ensure the accuracy and feasibility of the treatment goal; by projecting the upper surface of the device onto the outer surface of the skull, the fit of the device to the outer surface of the skull can be observed, and by optimizing the position and direction of the device, the bulge or protrusion between the device and the skull can be reduced, making the implantation site smoother and more natural; by calculating the fit of the pre-selected point, the most matching implantation point can be selected to ensure the optimal fit between the device and the skull.

[0210] The purpose of aligning the upper surface of the device with the outer surface of the skull is to accurately obtain the fit at the preselected points. In this embodiment, three alignment conditions are set.

[0211] The first condition is that the center point of the device's upper surface coincides with the preselected point. This ensures that the device is accurately positioned at a specific location on the skull's outer surface, without protruding outward at the preselected point. This prevents device deviation or misalignment during implantation, ensuring precise treatment targeting.

[0212] The second condition is that the height direction of the device's three-dimensional model is parallel to the normal of the skull's outer surface at the preselected point. By making the height direction of the device parallel to the normal of the skull's outer surface, the height direction of the device is ensured to be consistent with the thickness direction of the skull.

[0213] The third requirement is that the length of the 3D device model be parallel or perpendicular to the patient's midsagittal plane. This ensures that the device is aligned with the patient's anatomy in the transverse direction (i.e., the horizontal direction when the patient is standing), allowing the device to better adapt to the patient's head shape and anatomy, improving treatment accuracy and effectiveness. If the device's length is parallel or perpendicular to the patient's midsagittal plane, it will better conform to the side profile of the patient's head, reducing the potential for irregular protrusions or indentations at the implant site.

[0214] In some embodiments, the projection result includes a projection point corresponding to each point on the upper surface of the device;

[0215] The obtaining, according to the projection result, the degree of fit corresponding to the preselected point includes:

[0216] Calculate the difference in curvature between each point and its corresponding projected point;

[0217] Calculate the sum of squares of the differences in curvature corresponding to all points on the upper surface of the device;

[0218] The degree of fit corresponding to the preselected point is obtained according to the sum of squares.

[0219] In this embodiment, each point on the upper surface of the device is mapped or projected onto the outer surface of the skull to obtain a corresponding projection point.

[0220] The difference in curvature between each point and its corresponding projection point refers to the difference between the curvature of each point and the curvature of its corresponding projection point. The curvature of the projection point is the curvature of the outer surface of the skull at the projection point.

[0221] The sum of squares of differences in curvature is the sum of the squares of a set of values ​​(i.e., differences in curvature).

[0222] In this embodiment, the degree of fit is evaluated by calculating the sum of the squares of the curvature differences.

[0223] For example, suppose point A on the device's surface has a curvature of 5. The corresponding point projected onto the skull's outer surface is point B, whose curvature is 3. The curvature difference is 5 - 3 = 2. Similarly, the curvature differences between all points on the device's surface and their projected points are calculated, and the inverse of the sum of the squares of these differences is used as the degree of fit. The sum of squares can be used to assess the fit of preselected points. For example, a smaller sum of squares indicates a higher degree of fit between the device's surface and the skull's outer surface.

[0224] Each point on the device's upper surface is then projected onto the skull's outer surface to obtain its corresponding projection point. For each point, the difference between the curvature of that point and the curvature of its projection onto the skull's outer surface is calculated. This represents the difference in curvature between the point on the device and the skull's outer surface. The curvature differences for all points are squared and then summed to obtain the sum of squares. This sum of squares measures the overall adaptability of the curvature differences between all points on the device and the skull's outer surface. This approach offers the advantage of quantifying the degree of fit between the device's upper surface and the skull's outer surface by calculating the curvature differences and sum of squares, providing an objective metric for assessing the device's fit on the patient's skull. By assessing the fit of preselected points, the optimal implant location can be determined. For example, selecting the preselected point with the smallest sum of squares (i.e., the point with the highest fit) improves the fit of the implanted device to the skull's outer surface. Ensuring the fit of the device's upper surface to the skull's outer surface enhances surgical precision, reduces gaps or inappropriate contact between the device and the skull, and thus improves treatment efficacy.

[0225] In some embodiments, the projection result includes a projection image of the upper surface of the skull;

[0226] The method further comprises:

[0227] generating a first color mapping image corresponding to the surface of the device according to the curvature of each point on the surface of the device;

[0228] generating a second color mapping image corresponding to the outer surface of the skull according to the curvature of each point to be measured on the outer surface of the skull, wherein the second color mapping image and the first color mapping image adopt the same color mapping rule;

[0229] The obtaining, according to the projection result, the degree of fit corresponding to the preselected point includes:

[0230] intercepting a third color mapping image corresponding to the projection image from the second color mapping image;

[0231] calculating a similarity between the first color mapping image and the third color mapping image;

[0232] According to the similarity, the degree of fit corresponding to the preselected point is obtained.

[0233] The projected image refers to the projection image formed by projecting the upper surface of the device onto the outer surface of the skull.

[0234] A color-mapped image is an image that uses color to represent data or features. The first color-mapped image is generated based on the curvature of each point on the device's surface. Using specific color mapping rules, the curvature values ​​are mapped to corresponding colors. The second color-mapped image is generated based on the curvature of each point on the skull's outer surface. The same color mapping rules as the first color-mapped image are used to ensure consistency.

[0235] Color mapping is a technique for mapping data values ​​to a color space so that color can represent the characteristics or attributes of the data. By selecting a color mapping rule, the data range is mapped to different color values, thereby showcasing the characteristics and variations of the data in an image or visualization.

[0236] The color mapping image may be in the form of, for example, a heat map, a color map, a grayscale map, a gradient color map, a color cycle map, or the like.

[0237] Heatmaps primarily use varying intensities of color to represent relative values ​​or density changes in data. A heatmap is a graphical representation used to visualize the distribution and density of data. Typically, heatmaps use the intensity of color to represent relative values ​​or density. Higher values ​​or density are typically represented by warmer colors (such as red), while lower values ​​or density are represented by cooler colors (such as blue). Therefore, heatmaps primarily focus on the relative intensity or density changes in data.

[0238] Color maps represent the range and variation of data by mapping data values ​​to different colors. Color maps typically use a predefined color map to map data values ​​to different colors. Typical color maps include grayscale images (which map grayscale values ​​to black and white) and images using color maps like rainbows and heat maps. Color maps primarily focus on the specific magnitude and range of data values.

[0239] Grayscale maps map data values ​​to different grayscale values. Gradient color maps map data values ​​to color gradients. Color cycle maps map data values ​​to a cyclical sequence of colors. These different color mapping schemes can be used to visualize different features and properties of data.

[0240] The similarity is used to measure the similarity between the first color-mapped image and the third color-mapped image corresponding to the projection image. Various similarity metrics can be used, such as the structural similarity index (SSIM) or the mean square error (MSE).

[0241] The advantage of this is that by generating a color mapping image, the curvature distribution of the upper surface of the device and the outer surface of the skull can be intuitively compared, which helps to identify areas with higher or lower fit and provides clearer visual guidance; by calculating the similarity between the first color mapping image and the third color mapping image corresponding to the projection image, the degree of fit between the device and the outer surface of the skull can be quantitatively evaluated, providing an objective indicator for measuring the adaptability of the device on the patient's skull; based on the results of the similarity evaluation, the fit of the preselected point can be determined, for example, a higher similarity indicates a higher fit, so that a more suitable implantation point can be selected to improve the treatment effect and the patient's personalized treatment experience.

[0242] On the one hand, different color mapping formats can highlight the characteristic differences between the upper surface of the device and the outer surface of the skull, making them more noticeable and easier to observe. For example, a heat map can show the difference in curvature between the device and the skull, a color map can use different colors to represent different curvatures, and a grayscale map can show changes in curvature. On the other hand, color-mapped images can help doctors better interpret the relationship between the device and the skull. By observing the changes and distribution of colors, information can be obtained about the fit between the device and the skull, the distribution of curvature, and structural matching. In addition, different color mapping formats can be adjusted according to specific circumstances to suit the needs and individual differences of different patients. According to the patient's preferences, cognitive abilities, and perception of color, the appropriate color mapping format should be selected to make it easier to understand and accept.

[0243] In some embodiments, the color mapping rule is a curvature-based color mapping rule.

[0244] Therefore, a specific set of color mapping rules is formulated according to the curvature. According to the change of curvature, different colors are assigned to different curvature ranges to achieve visualization.

[0245] The advantage of this is that by using curvature-based color mapping rules, the curvature difference between the upper surface of the device and the outer surface of the skull can be highlighted, and different colors can be used to represent different degrees of curvature, so that doctors can more intuitively perceive and understand the curvature changes between the device and the skull; the curvature-based color mapping rules enable doctors to more quickly identify and distinguish different curvature areas on the upper surface of the device and the outer surface of the skull. By observing the color, the height of the curvature can be intuitively distinguished, which helps to determine the fit between the device and the skull; using curvature-based color mapping rules can present curvature information in an intuitive way, with different colors representing different curvature values, forming a clear visual contrast, which makes it easier for doctors to choose appropriate implantation points.

[0246] In some embodiments, the medical device is a pulse generator, and the method further comprises:

[0247] The planned implantation path of the electrode wire is obtained by planning.

[0248] Planning the implantation path refers to the implantation path of the electrode lead inside the skull to ensure safe and effective implantation of the electrode lead.

[0249] For example, by planning the implantation path, it is determined that the electrode wire (corresponding to the pulse generator) needs to pass through a specific channel or area inside the brain and ultimately reach the target location (such as the nucleus accumbens or the anterior limb of the internal capsule).

[0250] In this embodiment, the medical device is a pulse generator, a device used for electrical stimulation therapy. First, the brain tissue through which the electrode wires need to pass to reach the target area is determined. Next, the implantation site is determined using the aforementioned method, allowing the pulse generator to be implanted in the patient's skull.

[0251] The benefits of this are that, by planning the implantation path, the electrode wire can be accurately placed at the target location to achieve precise electrical stimulation therapy; the planned implantation path can minimize interference and trauma to the patient's tissue, thereby reducing surgical risks and recovery time; according to the patient's specific situation, by planning the implantation path, the position and direction of the electrode wire can be customized as needed to meet individualized treatment needs.

[0252] In a specific application scenario, an embodiment of the present application further provides a surgical planning method for implanting a medical device into a patient's head; the medical device is a pulse generator;

[0253] The process of determining the medical device includes: selecting from a plurality of models of candidate medical devices according to the skull thickness distribution result, and determining one of the models of the candidate medical devices as the medical device.

[0254] The method comprises:

[0255] Acquiring medical imaging data of the patient's skull;

[0256] performing a three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, the three-dimensional reconstruction result including a skull thickness distribution result and a three-dimensional skull model; the skull thickness distribution result is in the form of a skull thickness distribution heat map or a two-dimensional skull contour map; the three-dimensional skull model has relative skull inner and outer surfaces, and the thickness screening condition is used to indicate a thickness range corresponding to the medical device;

[0257] According to the skull thickness distribution result, detecting whether there is a point to be measured on the outer surface of the skull whose corresponding thickness is within the thickness range;

[0258] If so, one or more points to be measured on the outer surface of the skull with corresponding thickness within the thickness range are placed into a preselected point set;

[0259] Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other;

[0260] Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point;

[0261] Based on the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull;

[0262] The planned implantation path of the electrode wire is obtained by planning.

[0263] There are three ways to obtain the degree of fit corresponding to each pre-selected point.

[0264] First way:

[0265] The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

[0266] Second way:

[0267] The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0268] Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result; the projection result includes a projection point corresponding to each point on the upper surface of the device;

[0269] Calculate the difference in curvature between each point and its corresponding projected point;

[0270] Calculate the sum of squares of the differences in curvature corresponding to all points on the upper surface of the device;

[0271] The degree of fit corresponding to the preselected point is obtained according to the sum of squares.

[0272] The third way:

[0273] generating a first color mapping image corresponding to the surface of the device according to the curvature of each point on the surface of the device;

[0274] generating a second color mapping image corresponding to the outer surface of the skull according to the curvature of each point to be measured on the outer surface of the skull, wherein the second color mapping image and the first color mapping image adopt the same color mapping rule;

[0275] The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0276] Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result; the projection result includes a projection image of the upper surface of the skull;

[0277] intercepting a third color mapping image corresponding to the projection image from the second color mapping image;

[0278] calculating a similarity between the first color mapping image and the third color mapping image;

[0279] According to the similarity, the degree of fit corresponding to the preselected point is obtained.

[0280] Taking the example of a pulse generator (for a deep brain stimulation device) implanted in the head of patient A as a medical device, the pulse generator has an approximately rectangular shape with a length of 2 cm and a height of 0.5 cm. Both the upper and lower surfaces of the device are raised upward to fit the skull structure.

[0281] First, a CT scan is performed on patient A, acquiring CT data as medical imaging data. For example, the average skull thickness of patient A is detected to be 7 mm. Three-dimensional reconstruction is then performed based on these CT data, resulting in a 3D skull model and a skull thickness distribution heat map. During this process, the thickness of each target point on the skull's outer surface is checked to determine if it falls within the pulse generator's thickness range (e.g., 6.5-7.5 mm). A coarse search is performed using the first step length to obtain a coarse search result (i.e., the skull thickness corresponding to each coarse search point). Based on this coarse search result, one or more target regions are selected (e.g., clustering the coarse search points corresponding to skull thicknesses within this thickness range to obtain one or more target regions). A fine search is then performed on each target region using a second step length (smaller than the first step length). Assume that 100 preselected points meeting the criteria are found. A 3D model of the pulse generator device is then obtained, and the fit between the upper surface of the device and the skull's outer surface is calculated for each preselected point.

[0282] Using the first method, the difference between the curvature of the device's upper surface at its center and the curvature of the skull's outer surface at each preselected point can be calculated. For example, if the curvature of the device's upper surface at its center is 0.05 and the curvature of the skull's outer surface at preselected point 1 is 0.07, the difference between the two curvatures is 0.02. The inverse of the absolute value of this difference in curvature is the fit, so the fit for preselected point 1 is 50. This calculation is repeated for all preselected points.

[0283] According to the second method, a three-dimensional model of the device is set based on each preselected point so that the center point of the upper surface of the device coincides with the preselected point, and the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction is parallel or perpendicular to the midsagittal plane. The upper surface of the device is then projected onto the outer surface of the skull, and the difference in curvature between each point and its corresponding projection point is calculated, and then the sum of the squares of the differences in curvature corresponding to all points is calculated. For example, the sum of squares corresponding to preselected point 2 is 1.32. Taking the inverse of the sum of squares as the degree of fit, the degree of fit of preselected point 2 is 0.76. And so on, the degree of fit of all preselected points is calculated.

[0284] According to the third method, a first color-mapped image corresponding to the upper surface of the device and a second color-mapped image corresponding to the outer surface of the skull are generated. The upper surface of the device is then projected onto the outer surface of the skull, and a third color-mapped image corresponding to the projected image is captured from the color-mapped image of the outer surface of the skull. The similarity between the first and third color-mapped images of the upper surface of the device is then calculated. For example, the similarity for preselected point 3 is 0.95. If similarity is used as the degree of fit, then the degree of fit for preselected point 3 is 0.95. This process is repeated to calculate the fit for all preselected points.

[0285] The degree of fit at each preselected point is determined using any of the three methods above, and the preselected point with the highest degree of fit (e.g., preselected point 6) is selected as the implantation point for the device on the patient's skull. Furthermore, this surgical planning method can also plan the path of the electrode wire.

[0286] In the above embodiment, a thickness screening is performed on the skull's outer surface at points to be tested (e.g., 1000 points). Some of these points are then pre-selected as points and placed into a set of pre-selected points (e.g., 100 pre-selected points). Each pre-selected point is then tested for fit, and based on the fit of all pre-selected points, one of the pre-selected points is selected as the implant site. In other words, the pre-selected points are screened from the points to be tested, and the implant site is then selected from the pre-selected points.

[0287] When planning a surgery, in addition to considering the skull structure, the patient's age, gender, health status, and other biological characteristics can also be considered. This information can help doctors better understand the patient's physical condition, predict postoperative recovery, and determine the optimal medical device model and implant location. To improve the accuracy and efficiency of surgical planning, deep learning or machine learning can be used to automatically analyze and interpret medical imaging data, generate three-dimensional skull models, calculate skull thickness distribution, and select the optimal medical device and implant location. Because different medical devices may have different effects on the human body, device biocompatibility must be considered. For example, the device's material, design, and function can be used to assess its impact on the skull and surrounding tissues, as well as potential immune reactions or other complications. This allows for preoperative patient information and allows implant surgery to be performed with the patient's informed decision-making, thus avoiding potential medical disputes. To improve doctors' surgical skills and patient preparation, a surgical simulation system can be established. This system simulates the entire surgical process, including device selection, implant location (i.e., implant site), implant path planning, and potential problems and solutions. This helps doctors prepare in advance and provides patients with a clearer understanding of the procedure.

[0288] It should be noted that, provided that it is feasible, the order of the steps in the above embodiments can be adjusted, and this application does not limit this.

[0289] (Surgical Planning Equipment)

[0290] The embodiment of the present application also provides a surgical planning device, the specific embodiment of which is consistent with the embodiment described in the above method embodiment and the technical effects achieved, and some contents will not be repeated here.

[0291] The surgical planning device is used to implant a medical device into a patient's head. The surgical planning device includes a memory and at least one processor. The memory stores a computer program. The at least one processor is configured to implement the following steps when executing the computer program:

[0292] Acquiring medical imaging data of the patient's skull;

[0293] Performing three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes a skull thickness distribution result;

[0294] The implantation point of the medical device on the patient's skull is obtained according to the skull thickness distribution result and a preset thickness screening condition.

[0295] In some embodiments, the at least one processor is configured to determine the medical device in the following manner when executing the computer program:

[0296] According to the skull thickness distribution result, a model is selected from multiple models of candidate medical devices to determine one model of the candidate medical device as the medical device.

[0297] In some embodiments, the skull thickness distribution result is in the form of a skull thickness distribution heat map or a skull two-dimensional contour map.

[0298] In some embodiments, the three-dimensional reconstruction result further includes a three-dimensional skull model, wherein the three-dimensional skull model has a relative inner skull surface and an outer skull surface, and the thickness screening condition is used to indicate a thickness range corresponding to the medical device;

[0299] The at least one processor is configured to, when executing the computer program, obtain the implantation point of the medical device on the skull of the patient in the following manner:

[0300] According to the skull thickness distribution result, detecting whether there is a point on the outer surface of the skull with a corresponding thickness within the thickness range;

[0301] If so, one or more points on the outer surface of the skull corresponding to thicknesses within the thickness range are placed into a preselected point set;

[0302] One of the preselected points is determined from the set of preselected points as the implantation point of the medical device on the skull of the patient.

[0303] In some embodiments, the at least one processor is configured to, when executing the computer program, determine one of the preselected points from the set of preselected points as the implantation point of the medical device on the patient's skull in the following manner:

[0304] Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other;

[0305] Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point;

[0306] According to the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull.

[0307] In some embodiments, the at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner:

[0308] The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

[0309] In some embodiments, the at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner:

[0310] The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient;

[0311] Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result;

[0312] According to the projection result, the degree of fit corresponding to the preselected point is obtained.

[0313] In some embodiments, the projection result includes a projection point corresponding to each point on the upper surface of the device;

[0314] The at least one processor is configured to obtain the degree of fit corresponding to the preselected point in the following manner when executing the computer program:

[0315] Calculate the difference in curvature between each point and its corresponding projected point;

[0316] Calculate the sum of squares of the differences in curvature corresponding to all points on the upper surface of the device;

[0317] The degree of fit corresponding to the preselected point is obtained according to the sum of squares.

[0318] In some embodiments, the projection result includes a projection image of the upper surface of the skull;

[0319] The at least one processor is configured to further implement the following steps when executing the computer program:

[0320] generating a first color mapping image corresponding to the surface of the device according to the curvature of each point on the surface of the device;

[0321] generating a second color mapping image corresponding to the outer surface of the skull according to the curvature of each point to be measured on the outer surface of the skull, wherein the second color mapping image and the first color mapping image adopt the same color mapping rule;

[0322] The at least one processor is configured to obtain the degree of fit corresponding to the preselected point in the following manner when executing the computer program:

[0323] intercepting a third color mapping image corresponding to the projection image from the second color mapping image;

[0324] calculating a similarity between the first color mapping image and the third color mapping image;

[0325] According to the similarity, the degree of fit corresponding to the preselected point is obtained.

[0326] In some embodiments, the at least one processor is configured to further implement the following steps when executing the computer program:

[0327] The planned implantation path of the electrode wire is obtained by planning.

[0328] See also Figure 2 , Figure 2 It is a structural block diagram of a surgical planning device 10 provided in an embodiment of the present application.

[0329] The surgical planning device 10 may include, for example, at least one memory 11 , at least one processor 12 , and a bus 13 connecting different platform systems.

[0330] Memory 11 may include (computer) readable media in the form of volatile memory, such as random access memory (RAM) 111 and / or cache memory 112, and may further include read-only memory (ROM) 113. Memory 11 also stores a computer program, which can be executed by processor 12, causing processor 12 to implement the steps of any of the aforementioned methods. Memory 11 may also include a utility 114 having at least one program module 115. Such program modules 115 include, but are not limited to, an operating system, one or more application programs, other program modules, and program data. Each of these examples, or some combination thereof, may include an implementation of a network environment.

[0331] Accordingly, the processor 12 may execute the aforementioned computer program and the utility 114. The processor 12 may be implemented as one or more application-specific integrated circuits (ASICs), DSPs, programmable logic devices (PLDs), complex programmable logic devices (CPLDs), field-programmable gate arrays (FPGAs), or other electronic components.

[0332] The bus 13 may represent one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, an accelerated graphics port, a processor, or a local bus using any of a variety of bus architectures.

[0333] The surgical planning device 10 can also communicate with one or more external devices, such as a keyboard, pointing device, Bluetooth device, etc., one or more devices capable of interacting with the surgical planning device 10, and / or any device that enables the surgical planning device 10 to communicate with one or more other computing devices (e.g., a router, modem, etc.). Such communication can occur via an input / output interface 14. Furthermore, the surgical planning device 10 can communicate with one or more networks (e.g., a local area network (LAN), a wide area network (WAN), and / or a public network, such as the Internet) via a network adapter 15. The network adapter 15 can communicate with other modules of the surgical planning device 10 via a bus 13. It should be understood that, although not shown in the figures, other hardware and / or software modules may be used in conjunction with the surgical planning device 10 in practice, including but not limited to microcode, device drivers, redundant processors, external disk drive arrays, RAID systems, tape drives, and data backup storage platforms.

[0334] (Healthcare System)

[0335] The embodiments of the present application also provide a medical system, the specific embodiments of which are consistent with the embodiments described in the above method embodiments and the technical effects achieved, and some contents will not be repeated here.

[0336] See also Figure 3 , Figure 3 This is a structural block diagram of a medical system provided in an embodiment of the present application.

[0337] The medical system includes:

[0338] A surgical planning device for planning the implantation path of the electrode wire and obtaining the implantation point of the medical device on the patient's skull using the above method;

[0339] a surgical robot, configured to implant the electrode wire into the patient's head according to the planned implantation path;

[0340] The surgical navigation device is used to perform path navigation during the implantation process of the electrode wire so that the actual implantation path of the electrode wire matches the planned implantation path.

[0341] A surgical planning device is a device used for surgical planning that plans the path for lead implantation and determines the implantation point of the medical device on the patient's skull using any of the aforementioned surgical planning methods. It can be a computer-assisted tool or software system. For example, a surgical planning device can utilize CT data (or MRI data) and computational algorithms to obtain the coordinates of the planned implantation path and implantation point.

[0342] A surgical robot is a robotic system used to perform or assist in surgical procedures. It implants an electrode lead into the patient's head according to a pre-planned implantation path. The surgical robot can perform the implantation procedure according to preset programs and instructions. For example, the surgical robot can use an automated robotic arm to implant an electrode lead into a specific location on the patient's head along a pre-planned implantation path.

[0343] A surgical navigation device is a device used for real-time navigation and monitoring of the surgical robot's implantation process. The device can track the position of the electrode wire and match its actual implantation path with the pre-planned implantation path. If there is a mismatch, the device measures the positional and directional deviations and provides feedback to the surgical robot, allowing it to adjust the position and direction of the electrode wire in a timely manner. The device can also provide visual feedback and real-time positioning information to help doctors accurately observe the operation of the surgical robot during surgery. For example, the device can use sensors and imaging technologies, such as magnetic resonance imaging (MRI) or computed tomography (CT), to display the position of the electrode wire in real time and compare and adjust it with the pre-planned path.

[0344] Thus, the surgical planning device uses any of the above surgical planning methods to plan the implantation path of the electrode wire and obtain the implantation point of the medical device on the patient's skull. By analyzing the patient's skull anatomical data and imaging information, the surgical planning device is able to perform path planning and generate an implantation plan. The surgical robot implants the electrode wire into the patient's head according to the planned implantation path. It uses a robotic arm and a precise motion control system to accurately perform the implantation operation to ensure the correct positioning and safe insertion of the wire. The surgical navigation device is used to perform path navigation during the implantation process of the electrode wire to ensure that the actual implantation path matches the pre-planned path. The surgical navigation device uses imaging technology, sensors and positioning systems to track the position and direction of the wire in real time, and provides visual navigation guidance to help the surgical robot accurately locate and insert the electrode wire.

[0345] The benefit of doing this is that the use of medical systems can improve the precision and accuracy of surgery. The combination of surgical planning equipment and surgical navigation equipment can plan and guide the implantation process of electrode wires, ensuring that the electrode wires are accurately placed in the target position, thereby increasing the accuracy of treatment; using surgical robots for implantation operations can reduce surgical risks and human errors. The robotic system has precise motion control and stability, and can accurately control the implantation force and angle to reduce surgical risks; surgical navigation equipment provides real-time navigation guidance and visual feedback, allowing doctors to accurately observe and monitor the implantation process of electrode wires. This visualization enhances the safety and controllability of the operation. If necessary, doctors can control the surgical robot accordingly and make more accurate decisions during the operation.

[0346] Continue to see Figure 3 In some embodiments, the medical system further comprises:

[0347] an electrophysiological acquisition device, used to acquire electrophysiological data of the patient during the implantation process;

[0348] The surgical planning device is further configured to determine whether the planned implantation path needs to be updated based on the electrophysiological data of the patient; if an update is required, the planned implantation path of the patient is updated.

[0349] An electrophysiological acquisition device is a medical device used to collect electrophysiological data from patients. This data can include one or more of the following: electroencephalogram (EEG) data, electrocardiogram (ECG) data, electromyogram (EMG) data, and electrooculogram (EOG) data. Electrophysiological acquisition devices include components such as sensors, amplifiers, and data acquisition systems.

[0350] Surgical planning equipment not only determines the medical device implantation site and electrode lead implantation path based on imaging data but also utilizes electrophysiological data to determine whether the implantation path needs to be updated. For example, surgical planning equipment is equipped with image processing algorithms, path planning algorithms, and data analysis tools.

[0351] The planned implantation path is determined based on the patient's anatomy and treatment needs, ensuring accurate lead placement and effective treatment. If electrophysiological data indicates the currently planned implantation path is unsuitable, the surgical planning device can update it. Implantation path updating involves replanning and adjusting the lead implantation path based on real-time electrophysiological data and analysis results to better suit the patient's needs. The updated planned implantation path is then provided to the surgical robot and surgical navigation device.

[0352] For example, suppose a patient uses an electrophysiological acquisition device to collect EEG data during the implantation process. The surgical planning system generates an initial planned implantation path based on this data to ensure the electrode leads are correctly placed in the target area. However, during the implantation process, the electrophysiological data indicates that the treatment effect needs to be adjusted (for example, the patient's condition is not under control, or the EEG waveforms planned to be suppressed are not effectively suppressed). Based on this data, the surgical planning system determines that the implantation path needs to be updated and makes corresponding adjustments to ensure the accuracy and effectiveness of the treatment.

[0353] Thus, the electrophysiological acquisition device collects the patient's electrophysiological data during the implantation process and can obtain information about the patient's nervous system function and activity. During the implantation process, by evaluating the patient's electrophysiological data, the surgical planning device can determine whether the implantation path needs to be adjusted. If it is determined based on the electrophysiological data that the planned implantation path needs to be updated, the surgical planning device will update the patient's implantation path, such as replanning the implantation position of the electrode wire or adjusting the implantation depth to obtain a new planned implantation path. The surgical robot will perform the surgical operation according to the new planned implantation path, and the surgical navigation device will perform path navigation according to the new planned implantation path to ensure the accuracy and effectiveness of the treatment.

[0354] The advantage of this is that, based on the patient's electrophysiological data, the surgical planning device can customize the implantation path to better suit the patient's condition and treatment needs and provide an individualized treatment plan; by real-time monitoring and analysis of the patient's electrophysiological data, the surgical planning device can promptly discover and adjust the implantation path to ensure the accurate implantation of the electrode wire, improve the accuracy and effectiveness of the treatment, and maximize the optimization of the treatment effect, improving the patient's disease management and rehabilitation outcomes.

[0355] Continue to see Figure 3 In some embodiments, the medical system further comprises:

[0356] A medical device is implanted in the patient's head, collects the patient's electrophysiological data and sends it to the electrophysiological acquisition device, and delivers electrical stimulation to the patient's brain tissue.

[0357] In some embodiments, the medical device is a stimulation generator or a pulse generator.

[0358] A deep brain stimulation device is one type of stimulator. In addition to a pulse generator, a deep brain stimulation device also includes electrode leads, each of which can be implanted manually or with a surgical robot. During the implantation process, a surgical navigation device guides the surgeon or the robot.

[0359] See also Figure 4 and Figure 5 , Figure 4 This is a structural block diagram of a deep brain stimulation device provided in an embodiment of the present application. Figure 5 This is a structural block diagram of another deep brain stimulation device provided in an embodiment of the present application.

[0360] In some embodiments, the deep brain stimulation device comprises a pulse generator and at least one electrode lead implanted in the patient's head, wherein the pulse generator is directly connected to each electrode lead (e.g., Figure 4 When both the pulse generator and the electrode leads are implanted in the patient's head, the deep brain stimulation device may not include an extension lead, but only include the pulse generator and the electrode leads.

[0361] In other embodiments, the deep brain stimulation device includes a pulse generator implanted in the patient's body, at least one extension wire and at least one electrode wire implanted in the patient's head, the extension wire and the electrode wire have a corresponding relationship, and the pulse generator is connected to each electrode wire through the corresponding extension wire (such as Figure 5 shown).

[0362] In this embodiment, the number of electrode wires can be one or more. In the embodiment where an extension wire is provided, the number of extension wires can be one or more. The extension wires and the electrode wires have a corresponding relationship. The extension wires and the electrode wires can be one-to-one corresponding, and each extension wire is provided between its corresponding electrode wire and the pulse generator (such as Figure 5 The extension wires and electrode wires can also be connected in a one-to-many configuration, with one end of each extension wire connected to its corresponding N electrode wires via an adapter (e.g., a one-to-N adapter), and the other end of each extension wire connected to a pulse generator (not shown). N is an integer greater than 1, such as 2, 3, or 4.

[0363] In this embodiment, the pulse generator and the electrode wire are in communication connection, and the two can communicate directly (such as Figure 4 As shown), data interaction can also be achieved by extending the wire (as shown Figure 5 shown).

[0364] In this embodiment, the electrode leads can be implanted in the patient's target area, such as the nucleus accumbens, anterior limb of the internal capsule, caudate nucleus, lentiform nucleus, putamen, and other tissues, nuclei, fiber bundles, etc. The number of electrode leads can be, for example, 1, 2, 3, 4, 5, 6, etc. The number of electrode contacts per electrode lead can be, for example, 4, 6, 8, 9, 10, 12, 15, 18, etc. When multiple electrode leads are implanted in the patient's head, the multiple electrode leads can be implanted in the same hemisphere of the brain, or can be implanted in both hemispheres of the brain.

[0365] In an embodiment of the present application, the electrode wire can be used to sense the electrophysiological activity of single cells and / or multiple cells to obtain single cell electrophysiological signals and / or local field potentials. Local field potential (LFP) is a special type of electrophysiological signal. In a living body, the synaptic activity of dendrites in a certain volume of biological tissue will induce an electric current. When this current flows through the extracellular space with a certain impedance, a certain voltage distribution is formed. The local voltage value recorded at a certain point is called the local field potential.

[0366] Thus, an implantable deep brain stimulation device is used to provide electrical stimulation therapy to a region of a patient's brain, and the deep brain stimulation device can be configured in two different ways.

[0367] In the first configuration, the pulse generator is directly connected to the electrode lead. A deep brain stimulation device consists of a pulse generator and at least one electrode lead implanted in the patient's head. The pulse generator is directly connected to each electrode lead, delivering electrical stimulation to the target area through the electrode lead.

[0368] In the second configuration, the pulse generator and electrode leads are indirectly connected via extension leads. A deep brain stimulation device includes a pulse generator implanted in the patient, at least one extension lead, and at least one electrode lead implanted in the patient's head. The extension leads correspond to the electrode leads, for example, in a one-to-one or one-to-many relationship. The pulse generator connects to each electrode lead via the extension lead to deliver electrical stimulation.

[0369] The advantage of this is that implantable deep brain stimulation devices can provide highly targeted electrical stimulation therapy. By implanting electrode wires into specific areas of the patient's head, the pulse generator can accurately transmit electrical stimulation signals to the target area to achieve precise therapeutic effects. The configuration and parameters of the deep brain stimulation device can be adjusted and personalized according to the patient's specific situation. Doctors can choose appropriate configuration methods and electrical stimulation parameters according to the patient's condition and treatment needs to achieve the best therapeutic effect. Implantable deep brain stimulation devices can continuously provide electrical stimulation therapy to the brain area. Compared with non-implantable electrical stimulation devices, implantable devices can provide treatment more stably and persistently, which has significant advantages for diseases that require long-term treatment. The treatment process is more convenient and continuous, which improves the patient's comfort and quality of life.

[0370] Continue to see Figure 3 In some embodiments, the medical system further comprises:

[0371] A program-controlled device is used to send program-controlled instructions to the medical device, wherein the program-controlled instructions are used to adjust one or more stimulation parameters of the pulse generator.

[0372] (Computer-readable storage medium)

[0373] The embodiment of the present application also provides a computer-readable storage medium, the specific embodiment of which is consistent with the embodiment described in the above method embodiment and the technical effects achieved, and some contents will not be repeated here.

[0374] The computer-readable storage medium stores a computer program, and when the computer program is executed by at least one processor, the computer program implements the steps of any of the above methods or implements the functions of any of the above surgical planning devices.

[0375] Computer readable medium can be a computer readable signal medium or a computer readable storage medium. In an embodiment of the present application, a computer readable storage medium can be any tangible medium containing or storing a program, which can be used by an instruction execution system, device or device or used in combination with it. Computer readable storage medium can be, for example, but not limited to, a system, device or device of electricity, magnetism, light, electromagnetic, infrared, or semiconductor, or any combination thereof. More specific examples (non-exhaustive list) of computer readable storage medium include: an electrical connection with one or more wires, a portable disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof.

[0376] A computer-readable storage medium may include a data signal propagated in baseband or as part of a carrier wave, carrying readable program code. This propagated data signal may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. A computer-readable storage medium may also be any computer-readable medium that can transmit, propagate, or transfer a program for use by or in conjunction with an instruction execution system, apparatus, or device. The program code contained on the computer-readable storage medium may be transmitted using any suitable medium, including but not limited to wireless, wired, optical cable, RF, or any suitable combination thereof. The program code used to perform the operations of the present invention may be written in any combination of one or more programming languages, including Java, C++, Python, C#, JavaScript, PHP, Ruby, Swift, Go, Kotlin, and the like. The program code may be executed entirely on the user computing device, partially on the user device, as a standalone software package, partially on the user device and partially on a remote computing device, or entirely on a remote computing device or server. Where a remote computing device is involved, the remote computing device may be connected to the user device through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device (e.g., through the Internet using an Internet service provider).

[0377] (Computer Program Product)

[0378] The embodiments of the present application also provide a computer program product, the specific embodiments of which are consistent with the embodiments described in the above method embodiments and the technical effects achieved, and some contents will not be repeated here.

[0379] The computer program product includes a computer program, and when the computer program is executed by at least one processor, the computer program implements the steps of any of the above methods or implements the functions of any of the above surgical planning devices.

[0380] See also Figure 6 , Figure 6 It is a structural diagram of a computer program product provided in an embodiment of the present application.

[0381] The computer program product is used to implement the steps of any of the aforementioned methods or the functions of any of the aforementioned surgical planning devices. The computer program product may be implemented in a portable compact disc read-only memory (CD-ROM) and include program code, and may be run on a terminal device, such as a personal computer. However, the computer program product of the present invention is not limited thereto and may be implemented in any combination of one or more computer-readable media.

[0382] This application is explained from the perspectives of purpose of use, effectiveness, progress and novelty. The above description and drawings of this application are only preferred embodiments of this application and are not intended to limit this application. Therefore, all structures, devices, features, etc. that are similar or identical to those of this application, that is, all equivalent replacements or modifications made in accordance with the scope of the patent application of this application, should fall within the scope of protection of the patent application of this application.

Claims

1. A surgical planning device, characterized in that: The surgical planning device is used to implant a medical device into a patient's head, the surgical planning device comprising a memory and at least one processor, the memory storing a computer program, the at least one processor being configured to implement the following steps when executing the computer program: Acquiring medical imaging data of the patient's skull; Performing three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes a skull thickness distribution result; Obtaining an implantation point of the medical device on the patient's skull based on the skull thickness distribution result and a preset thickness screening condition; The at least one processor is configured to, when executing the computer program, determine one of the preselected points from a set of preselected points as an implantation point of the medical device on the skull of the patient in the following manner: Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other; Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point; Based on the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull; The at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner: The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

2. The surgical planning device according to claim 1, wherein: The skull thickness distribution result is in the form of a skull thickness distribution heat map or a skull two-dimensional contour map.

3. The surgical planning device according to claim 1, wherein: The three-dimensional reconstruction result further includes a three-dimensional skull model, wherein the three-dimensional skull model has a relative inner skull surface and an outer skull surface, and the thickness screening condition is used to indicate a thickness range corresponding to the medical device; The at least one processor is configured to, when executing the computer program, obtain the implantation point of the medical device on the skull of the patient in the following manner: According to the skull thickness distribution result, detecting whether there is a point to be measured on the outer surface of the skull whose corresponding thickness is within the thickness range; If so, one or more points to be measured on the outer surface of the skull with corresponding thickness within the thickness range are placed into a preselected point set; One of the preselected points is determined from the set of preselected points as the implantation point of the medical device on the skull of the patient.

4. The surgical planning device according to claim 1, wherein: The at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner: The three-dimensional model of the device is arranged based on the preselected point, so that the center point of the upper surface of the device coincides with the preselected point, the height direction of the three-dimensional model of the device is parallel to the normal of the outer surface of the skull at the preselected point, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the midsagittal plane of the patient; Projecting the upper surface of the device onto the outer surface of the skull to obtain a projection result; According to the projection result, the degree of fit corresponding to the preselected point is obtained.

5. The surgical planning device according to claim 4, characterized in that The projection result includes a projection point corresponding to each point on the surface of the device; The at least one processor is configured to obtain the degree of fit corresponding to the preselected point in the following manner when executing the computer program: Calculate the difference in curvature between each point and its corresponding projected point; Calculate the sum of squares of the differences in curvature corresponding to all points on the upper surface of the device; The degree of fit corresponding to the preselected point is obtained according to the sum of squares.

6. The surgical planning device according to claim 4, wherein: The projection result includes a projection image of the upper surface of the skull; The at least one processor is configured to further implement the following steps when executing the computer program: generating a first color mapping image corresponding to the surface of the device according to the curvature of each point on the surface of the device; generating a second color mapping image corresponding to the outer surface of the skull according to the curvature of each point to be measured on the outer surface of the skull, wherein the second color mapping image and the first color mapping image adopt the same color mapping rule; The at least one processor is configured to obtain the degree of fit corresponding to the preselected point in the following manner when executing the computer program: intercepting a third color mapping image corresponding to the projection image from the second color mapping image; calculating a similarity between the first color mapping image and the third color mapping image; According to the similarity, the degree of fit corresponding to the preselected point is obtained.

7. The surgical planning device according to claim 1, wherein: The at least one processor is configured to further implement the following steps when executing the computer program: The planned implantation path of the electrode wire is obtained by planning.

8. A surgical planning method, characterized in that: For implanting a medical device into a patient's head, the method comprises: Acquiring medical imaging data of the patient's skull; Performing three-dimensional reconstruction of the patient's skull based on the medical imaging data to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes a skull thickness distribution result; Obtaining an implantation point of the medical device on the patient's skull based on the skull thickness distribution result and a preset thickness screening condition; The at least one processor is configured to, when executing the computer program, determine one of the preselected points from the set of preselected points as the implantation point of the medical device on the skull of the patient in the following manner: Acquire a three-dimensional model of the medical device, wherein the three-dimensional model has an upper device surface and a lower device surface relative to each other; Obtaining the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point; Based on the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point, the preselected point with the highest degree of fit is used as the implantation point of the medical device on the patient's skull; The at least one processor is configured to, when executing the computer program, obtain the degree of fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner: The degree of fit between the upper surface of the device and the outer surface of the skull corresponding to the preselected point is determined based on the curvature of the upper surface of the device at its own center point and the curvature of the outer surface of the skull at the preselected point.

9. A medical system, characterized in that: The medical system includes: A surgical planning device for planning an implantation path of an electrode wire and obtaining an implantation point of the medical device on the patient's skull using the method of claim 8; a surgical robot, configured to implant the electrode wire into the patient's head according to the planned implantation path; The surgical navigation device is used to perform path navigation during the implantation process of the electrode wire so that the actual implantation path of the electrode wire matches the planned implantation path.

10. The medical system according to claim 9, characterized in that The medical system further comprises: an electrophysiological acquisition device, used to acquire electrophysiological data of the patient during the implantation process; The surgical planning device is further configured to determine whether the planned implantation path needs to be updated based on the electrophysiological data of the patient; if an update is required, the planned implantation path of the patient is updated.

11. The medical system according to claim 10, characterized in that The medical system further comprises: The medical device is implanted in the patient's head, collects the patient's electrophysiological data and sends it to the electrophysiological acquisition device, and delivers electrical stimulation to the patient's brain tissue.

12. The medical system according to claim 11, wherein: The medical device is a pulse generator.

13. A computer-readable storage medium, characterized in that The computer-readable storage medium stores a computer program, and when the computer program is executed by at least one processor, it implements the functions of the surgical planning device according to any one of claims 1 to 7 or implements the steps of the method according to claim 8.

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